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AEZS:MoreThanFiveYearsMember
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AEZS:ServicesAndManufacturingMember
2021-12-31
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AEZS:ResearchAndDevelopmentContractMember
2021-12-31
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AEZS:ResearchAndDevelopmentMember
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2021-12-31
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AEZS:ResearchAndDevelopmentContractsMember
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2021-12-31
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AEZS:ResearchAndDevelopmentMileStonePaymentsMember
2021-01-01
2021-12-31
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AEZS:ResearchAndDevelopmentMileStonePaymentsMember
AEZS:LessThanOneYearMember
2021-12-31
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AEZS:RevenueRelatedMileStonePaymentsMember
AEZS:LessThanOneYearMember
2021-12-31
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AEZS:ResearchAndDevelopmentMileStonePaymentsMember
AEZS:OneToThreeYearsMember
2021-12-31
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AEZS:RevenueRelatedMileStonePaymentsMember
AEZS:OneToThreeYearsMember
2021-12-31
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AEZS:ResearchAndDevelopmentMileStonePaymentsMember
AEZS:FourToFiveYearsMember
2021-12-31
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AEZS:RevenueRelatedMileStonePaymentsMember
AEZS:FourToFiveYearsMember
2021-12-31
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AEZS:ResearchAndDevelopmentMileStonePaymentsMember
AEZS:MoreThanFiveYearsMember
2021-12-31
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AEZS:RevenueRelatedMileStonePaymentsMember
AEZS:MoreThanFiveYearsMember
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AEZS:RevenueRelatedMileStonePaymentsMember
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iso4217:USD
xbrli:shares
iso4217:USD
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xbrli:pure
iso4217:CAD
iso4217:EUR
AEZS:Integer
iso4217:GBP
PART
I
Item
1. |
Identity
of Directors, Senior Management and Advisers |
A. |
Directors
and senior management |
Not
applicable.
Not
applicable.
Not
applicable.
Item
2. |
Offer
Statistics and Expected Timetable |
Not
applicable.
B. |
Method
and expected timetable |
Not
applicable.
B. |
Capitalization
and indebtedness |
Not
applicable.
C. |
Reasons
for the offer and use of proceeds |
Not
applicable.
An
investment in our securities involves a high degree of risk. You should carefully consider the risks described below, together with all
of the other information included in this Annual Report, before making an investment decision. If any of the following risks actually
occur, our business, prospects, financial condition or results of operations could be materially, adversely affected by any of these
risks. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. The trading
price of our securities could decline due to any of these risks, and you may lose all or part of your investment. This Annual Report
also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those
anticipated in these forward-looking statements as a result of certain factors, including the risks mentioned below. Forward-looking
statements included in this Annual Report are based on information available to us on the date hereof, and all forward-looking statements
in the documents incorporated by reference are based on information available to us as of the date of each such document. We disavow
and are under no obligation to update or alter such forward-looking statements whether as a result of new information, future events
or otherwise, other than as required by applicable securities legislation.
Risks
Relating to Us and Our Business
Our
Common Shares may be delisted from the NASDAQ or the TSX, which could affect their market price and liquidity. If our Common Shares were
to be delisted, investors may have difficulty in disposing their Common Shares.
Our
Common Shares are currently listed on both the NASDAQ and the TSX under the symbol “AEZS”. We must meet continuing listing
requirements to maintain the listing of our Common Shares on the NASDAQ and the TSX. For continued listing, the NASDAQ requires, among
other things, that listed securities maintain a minimum closing bid price of not less than $1.00 per share. On July 28, 2021, we received
a letter from the Listing Qualifications Staff of the NASDAQ (the “Staff”), notifying us that for the last 30 consecutive
business days prior to the date of the letter, the closing bid price of our common shares was below $1.00 per share and, therefore, we
did not meet the requirement for continued listing on Nasdaq as required by Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were granted a grace period of 180 calendar days, through January 24, 2022,
and on January 26, 2022, we were granted a subsequent 180 calendar day extension, through July 26, 2022, to evidence compliance with
the Bid Price Rule. If at any time before July 26, 2022, the bid price for the Company’s common shares closes at or above US$1.00
per share for a minimum of 10 consecutive business days (and generally not more than 20 consecutive business days, in NASDAQ’s
discretion), it is expected that NASDAQ would provide formal notice that the Company has regained compliance with the bid price requirement.
The Company may choose to implement a reverse stock split before July 26, 2022 in order to regain compliance. In the event the Company
does not evidence compliance with the minimum bid price requirement during the 180-day grace period, it is expected that Nasdaq would
notify the Company that its shares are subject to delisting. At such time, the Company may appeal such determination to a Nasdaq Hearings
Panel (the “Panel”) and it is expected that the Company’s securities would continue to be listed and available to trade
on Nasdaq at least pending the completion of the appeal process. There can be no assurance that any such appeal would be successful or
that the Company would be able to evidence compliance with the terms of any extension that may be granted by the Panel. The NASDAQ notification
letter does not impact the Company’s compliance or listing status on the Toronto Stock Exchange.
On
July 27, 2020, we received a letter from the Staff notifying us that for the last thirty (30) consecutive business days prior to the
date of the letter, the closing bid price of our Common Shares was below $1.00 per share and, therefore, we did not meet the requirement
for continued listing on the NASDAQ as required the Bid Price Rule. In accordance with NASDAQ Listing Rule 5810(c)(3)(A), we were granted
a grace period of one hundred and eighty (180) calendar days, through January 25, 2021, and on January 26, 2021, we were granted a subsequent
180 calendar day extension, through July 26, 2021, to evidence compliance with the Bid Price Rule. On March 22, 2021, the Company received
confirmation that it had regained compliance with the Bid Price Rule and NASDAQ advised us that this matter was then closed.
In
addition to the minimum bid price requirement, the continued listing rules of the NASDAQ require us to meet at least one of the following
listing standards: (i) stockholders’ equity of at least $2.5 million, (ii) market value of listed securities (calculated by multiplying
the daily closing bid price of our securities by our total outstanding securities) of at least $35 million or (iii) net income from continuing
operations (in the latest fiscal year or in two of the last three fiscal years) of at least $500,000.
It
is possible that we may be a passive foreign investment company, which could result in adverse tax consequences to U.S. investors.
Adverse
U.S. federal income tax rules apply to “U.S. Holders” who directly or indirectly hold stock of a passive foreign investment
company (“PFIC”). We would be classified as a PFIC for U.S. federal income tax purposes for a taxable year if (i)
at least 75% of our gross income is “passive income” or (ii) at least 50% of the average value of our assets, including goodwill
(based on annual quarterly average), is attributable to assets which produce passive income or are held for the production of passive
income.
The
determination of whether we are, or will be, a PFIC for a taxable year depends, in part, on the application of complex U.S. federal income
tax rules, which are subject to various interpretations. Although the matter is not free from doubt, we believe that we were not a PFIC
during our 2020 taxable year and will not likely be a PFIC during our 2021 taxable year. Because PFIC status is based on our income,
assets and activities for the entire taxable year, and our market capitalization, it is not possible to determine whether we will be
characterized as a PFIC for the 2021 taxable year until after the close of the taxable year. The tests for determining PFIC status are
subject to a number of uncertainties. These tests are applied annually, and it is difficult to accurately predict future income, assets
and activities relevant to this determination. In addition, because the market price of our Common Shares is likely to fluctuate, the
market price may affect the determination of whether we will be considered a PFIC. There can be no assurance that we will not be considered
a PFIC for any taxable year (including our 2021 taxable year).
If
we are a PFIC for any taxable year during which a U.S. Holder holds Common Shares, we generally would continue to be treated as a PFIC
with respect to that U.S. Holder for all succeeding years during which the U.S. Holder holds such Common Shares, even if we ceased to
meet the threshold requirements for PFIC status. Accordingly, no assurance can be given that we will not constitute a PFIC in the current
(or any future) tax year or that the Internal Revenue Service (the “IRS”) will not challenge any determination made
by us concerning our PFIC status. PFIC characterization could result in adverse U.S. federal income tax consequences to U.S. Holders.
In particular, absent certain elections, a U.S. Holder would generally be subject to U.S. federal income tax at ordinary income tax rates,
plus a possible interest charge, in respect of a gain derived from a disposition of our Common Shares, as well as certain distributions
by us. If we are treated as a PFIC for any taxable year, a U.S. Holder may be able to make an election to “mark-to-market”
Common Shares each taxable year and recognize ordinary income pursuant to such election based upon increases in the value of the Common
Shares.
In
addition, U.S. Holders may mitigate the adverse tax consequences of the PFIC rules by making a “qualified electing fund”
(“QEF”) election; however, there can be no assurance that we will satisfy the record keeping requirements applicable
to a QEF or that we will provide the information regarding our income that would be necessary for a U.S. Holder to make a QEF election.
If
the Company is a PFIC, U.S. Holders will generally be required to file an annual information return with the IRS (on IRS Form 8621 Information
Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing Fund, which PFIC shareholders will be required
to file with their U.S. federal income tax or information returns) relating to their ownership of Common Shares. This filing requirement
is in addition to any pre-existing reporting requirements that apply to a U.S. Holder’s interest in a PFIC (which this requirement
does not affect).
Our
net operating losses may be limited for U.S. federal income tax purposes under Section 382 of the Internal Revenue Code.
If
a corporation with net operating losses (“NOLs”) undergoes an “ownership change” within the meaning of
Section 382 of the United States Internal Revenue Code of 1986, as amended (the “Code”), then such corporation’s
use of such “pre-change” NOLs to offset income incurred following such ownership change may be limited. Such limitation also
may apply to certain losses or deductions that are “built-in” (i.e., attributable to periods prior to the ownership change,
but not yet taken into account for tax purposes) as of the date of the ownership change that are subsequently recognized. An ownership
change generally occurs when there is either (i) a shift in ownership involving one or more “5% shareholders,” or (ii) an
“equity structure shift” and, as a result, the percentage of stock of the corporation owned by one or more 5% shareholders
(based on value) has increased by more than 50 percentage points over the lowest percentage of stock of the corporation owned by such
shareholders during the “testing period” (generally the 3 years preceding the testing date). In general, if such change occurs,
the corporation’s ability to utilize its NOL carry-forwards and certain other tax attributes would be subject to an annual limitation,
as described below. The unused portion of any such NOL carry-forwards or tax attributes each year is carried forward, subject to the
same limitation in future years. The impact of an ownership change on state NOL carry forwards may vary from state to state. Due
to previous ownership changes, or if we undergo an ownership change in connection with or after this offering, our ability to use our
NOLs could be limited by Section 382 of the Code. Future changes to our stock ownership, some of which are outside of our control, could
result in an ownership change under Section 382 of the Code. Recent legislation added several limitations to the ability to claim deductions
for NOLs in future years, particularly for tax years beginning after December 31, 2020, including a deduction limit equal to 80% of taxable
income and a restriction on NOL carryback deductions. For these reasons, we may not be able to use a material portion of the NOLs, even
if we attain profitability.
Prevention
of Transactions Involving a Change of Control of the Company
Effective
May 8, 2019, the shareholders re-approved our Rights Plan that provides the Board and the Company’s shareholders with additional
time to assess any unsolicited take-over bid for the Company and, where appropriate, to pursue other alternatives for maximizing shareholder
value. Under the Rights Plan, one right has been issued for each currently issued Common Share, and one right will be issued with each
additional Common Share that may be issued from time to time. The Rights Plan may have a significant anti-takeover effect. The Rights
Plan has the potential to significantly dilute the ownership interests of an acquiror of our shares, and therefore may have the effect
of delaying, deterring or preventing a change in control of the Company.
The
economic effects of a pandemic, epidemic or outbreak of an infectious disease could adversely affect our operations or the market price
of our Common Shares.
Public
health crises such as pandemics, epidemics or similar outbreaks could adversely impact our operations or the market price of our Common
Shares. Specifically, the global pandemic declared regarding the novel strain of coronavirus (“COVID-19”) in
2020 and 2021 that adversely impacted global markets is abating, but currently ongoing. The extent to which the COVID-19 impacts our
operations or market price of our Common Shares will depend on future developments, which are highly uncertain and cannot be predicted
with confidence, either internationally or within the U.S., Canada or Germany, including the duration of the outbreak, new information
that may emerge concerning the severity of the COVID-19, and the actions to contain the virus or treat its impact, among others. COVID-19,
however, has already resulted in significant volatility in the world and the national trading markets.
The
spread of COVID-19 may impact our operations, including the potential interruption of our clinical trial activities and our supply chain.
For example, the rise in the Omicron variant in the COVID-19 pandemic has caused delays in site initiation and patient enrollment in
our Phase 3 DETECT clinical trial for diagnostic use in childhood-onset growth hormone deficiency. As well, sales activities for Macrilen™
in the US by Novo Nordisk may be impacted due to delays of diagnostic activities on adult growth hormone deficiency (“AGHD”)
in the U.S. In addition, the COVID-19 pandemic may also cause some patients to be unwilling to enroll in our trials or be unable to comply
with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay our ability
to conduct clinical trials or release clinical trial results on a timely basis and could delay our ability to obtain regulatory approval
and commercialize our product candidates. The spread of an infectious disease, including COVID-19, may also result in the inability of
our suppliers to deliver components or raw materials on a timely basis or at all. In addition, hospitals may reduce staffing and reduce
or postpone certain treatments in response to the spread of an infectious disease. Such events may result in a period of business disruption
and, in reduced operations, doctors or medical providers may be unwilling to participate in our clinical trials, any of which could materially
affect our business, financial condition or results of operations. The significant spread of COVID-19 within the U.S., Canada or Germany
resulted in a widespread health crisis and has had adverse effect on the national economies generally, the markets that we serve, our
operations and the market price of our Common Shares.
Investments
in biopharmaceutical companies are generally considered to be speculative in nature.
The
prospects for companies operating in the biopharmaceutical industry are uncertain, given the very nature of the industry, in which companies
often experience lengthy development time, extensive capital requirements, rapid technological developments and a high degree of competition
based primarily on scientific and technological factors. These factors include the availability to obtain patent and other protection
for technology and products, the ability to commercialize technological developments and the ability to obtain government approval for
testing, manufacturing and marketing. Accordingly, investments in biopharmaceutical companies should be considered to be speculative
assets.
.
If
we are unable to successfully commercialize or out-license Macrilen™ (macimorelin), or if we experience significant delays in doing
so, our business would be materially harmed, and the future and viability of the Company could be imperiled.
Our
lead product, Macrilen™ (macimorelin), is the first and only U.S. Food and Drug Administration and European Commission approved
oral test indicated for the diagnosis of patients with AGHD and we currently do not have any other products. We are focused on opportunistically
utilizing our network with universities in Europe and the U.S., which we believe will provide vital access to innovative development
candidates in different indications, with a focus on rare or orphan indications and potential for pediatric use. To date, we have signed
agreements to establish this growing pipeline across a number of indications, including neuromyelitis optica spectrum disorder (“NMOSD”)
and Parkinson’s disease (“PD”), primary hypoparathyroidism and amyotrophic lateral sclerosis (“ALS”, or
Lou Gehrig’s disease). Additionally, we are developing oral prophylactic bacterial vaccines against each form of SARS-CoV-2, the
virus that causes COVID-19, and chlamydia.
We
are a party to license agreements to carry out development, manufacturing, registration and commercialization of Macrilen™ (macimorelin)
in the U.S., Canada, the European Economic Area, the United Kingdom, and the Republic of Korea. We are party to a distribution agreement for the commercialization of Macrilen™ (macimorelin) in Israel and the Palestinian Authority, Turkey and some non-European Union
Balkan countries. We continue to explore licensing and distribution opportunities worldwide.
The
commercial success of Macrilen™ (macimorelin) depends on several factors, including, but not limited to, the following:
|
● |
receipt
of approvals from foreign regulatory authorities; |
|
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|
● |
successfully
negotiating pricing and reimbursement in key markets in the EU for Macrilen™ (macimorelin); |
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● |
successfully
contracting with qualified third-party suppliers to manufacture Macrilen™ (macimorelin); |
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● |
developing
appropriate distribution and marketing infrastructure and arrangements for our product; |
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● |
launching
and growing commercial sales of the product; |
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● |
out-licensing
Macrilen™ (macimorelin) to third parties; and |
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● |
acceptance
of the product in the medical community, among patients and with third-party payers. |
If
we are unable to successfully achieve any of these factors, our business, financial condition and results of operations may be materially,
adversely affected.
Our
revenues and expenses may fluctuate significantly, and any failure to meet financial expectations may disappoint securities analysts
or investors and result in a decline in the price or the value of our Common Shares or other securities.
We
have a history of operating losses. Our revenues and expenses have fluctuated in the past and may continue to do so in the future. These
fluctuations could cause our share price of Common Shares or the value of our other securities to decline. Some of the factors that could
cause our revenues and expenses to fluctuate include, but are not limited to, the following:
|
● |
the
timing and willingness of any current or future collaborators to invest the resources necessary to commercialize Macrilen™
(macimorelin); |
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|
● |
not
obtaining necessary regulatory approvals from the United States Food & Drug Administration (“FDA”), the European
Medicines Agency (“EMA”), the European Commission (“EC”) or other agencies that may delay or prevent us from
obtaining approval of a pediatric indication for Macrilen™ (macimorelin), which may affect the share price of our Common Shares; |
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● |
the
timing of regulatory submissions and approvals; |
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● |
the
nature and timing of licensing fee revenues; |
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● |
the
outcome of future litigation; |
|
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● |
foreign
currency fluctuations; |
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● |
the
effects of the recent outbreak of COVID-19, including the effects of intensified efforts to contain the spread of the virus, which
has, to date, included, among other things, quarantines and travel restrictions; |
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● |
the
timing of the achievement and the receipt of milestone payments from current or future licensing partners; and |
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● |
failure
to enter into new or the expiration or termination of current agreements with suppliers who manufacture Macrilen™ (macimorelin). |
Due
to fluctuations in our revenues and expenses, we believe that period-to-period comparisons of our results of operations are not necessarily
indicative of our future performance. It is possible that in some future periods, our revenues and expenses will be above or below the
expectations of securities analysts or investors. In this case, the share price of our Common Shares and the value of our other securities
could fluctuate significantly or decline.
If
we are unable to successfully complete the pediatric clinical trial program for Macrilen™ (macimorelin), or if such clinical trial
takes longer to complete than we project, our ability to execute any related business strategy will be adversely affected.
If
we experience delays in identifying and contracting with sites and/or in-patient enrollment in our pediatric clinical trial program for
Macrilen™ (macimorelin), we may incur additional costs and delays in our development programs, and may not be able to complete
our clinical trials on a cost-effective or timely basis. In addition, conducting multi-national studies adds another level of complexity
and risk as we are subject to events affecting countries other than the U.S. and Canada. Moreover, negative or inconclusive results from
the clinical trials we conduct or adverse medical events could cause us to have to repeat or terminate the clinical trials. Furthermore,
children have different metabolic issues than adults. Accordingly, we may not be able to complete the pediatric clinical trial within
an acceptable time-frame, if at all. If we or our Contract Research Organizations (“CRO”) have difficulty enrolling a sufficient
number of patients to conduct our clinical trials as planned, we may need to delay or terminate ongoing clinical trials.
Clinical
trials are subject to continuing oversight by governmental regulatory authorities and institutional review boards and must, among other
requirements:
|
● |
meet
the requirements of these authorities from multiple countries and jurisdictions and their related statutes, regulations and guidance; |
|
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● |
meet
the requirements for informed consent; |
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● |
meet
the requirements for institutional review boards; and |
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● |
meet
the requirements for good clinical practices. |
We
are currently dependent on certain strategic relationships with third parties for the development, manufacturing and licensing of Macrilen™
(macimorelin) and we may enter into future collaborations for the development, manufacturing and licensing of Macrilen™ (macimorelin).
Our
arrangements with third parties may not provide us with the benefits we expect and may expose us to a number of risks.
Currently,
we are dependent on various partners to commercialize macimorelin in the U.S. and Canada, the U.K. and EU and the Republic of
Korea. Most of our potential revenue consists of contingent payments, including milestones and royalties on the sale of Macrilen™
(macimorelin). The milestone and royalty revenue that we may receive under this collaboration will depend upon these parties’ ability
to successfully introduce, market and sell Macrilen™ (macimorelin). If they do not devote sufficient time and resources to their
respective collaboration arrangements with us, we may not realize the potential commercial benefits of the arrangement, and our results
of operations may be materially, adversely affected.
Our
reliance on these relationships and other potential third parties poses a number of risks. We may not realize the contemplated benefits
of such agreements nor can we be certain that any of these parties will fulfill their obligations in a manner which maximizes our revenue.
These arrangements may also require us to transfer certain material rights to third parties. These agreements create certain additional
risks. The occurrence of any of the following or other events may delay or impair commercialization of Macrilen™ (macimorelin):
|
● |
in
certain circumstances, third parties may assign their rights and obligations under these agreements to other third parties without
our consent or approval; |
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● |
the
third parties may cease to conduct business for financial or other reasons; |
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● |
we
may not be able to renew such agreements; |
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the
third parties may not properly maintain or defend certain intellectual property rights that may be important to the commercialization
of Macrilen™ (macimorelin); |
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the
third parties may encounter conflicts of interest, changes in business strategy or other issues which could adversely affect their
willingness or ability to fulfill their obligations to us (for example, pharmaceutical companies historically have re-evaluated their
priorities following mergers and consolidations, which have been common in this industry); |
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delays
in, or failures to achieve, scale-up to commercial quantities, or changes to current raw material suppliers or product manufacturers
(whether the change is attributable to us or the supplier or manufacturer) could delay clinical studies, regulatory submissions and
commercialization of Macrilen™ (macimorelin); and |
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|
● |
disputes
may arise between us and the third parties that could result in the delay or termination of the manufacturing or commercialization
of Macrilen™ (macimorelin), resulting in litigation or arbitration that could be time-consuming and expensive, or causing the
third parties to act in their own self-interest and not in our interest or those of our shareholders. |
In
addition, the third parties can terminate our agreements with them for a number of reasons based on the terms of the individual agreements
that we have entered into with them. If one or more of these agreements were to be terminated, we would be required to devote additional
resources to manufacturing and commercializing Macrilen™ (macimorelin).
We
may be unsuccessful in consummating further out-licensing arrangements for MacrilenTM (macimorelin) on favorable terms and
conditions, or we may be significantly delayed in doing so.
As
part of our product development and commercialization strategy, we are evaluating out-licensing opportunities for Macrilen™ (macimorelin)
in addition to existing License Agreements signed with Novo Nordisk, Consilient Health and NK MEDITECH Ltd. by the end of 2021. If we
elect to collaborate with third parties in respect of macimorelin, we may not be able to negotiate a collaborative arrangement for macimorelin
on favorable terms and conditions, if at all. Should any partner fail to successfully commercialize macimorelin, our business, financial
condition and results of operations may be adversely affected.
We
have initiated significant early-stage pre-clinical programs
Over
the course of 2021, we in-licensed six new pre-clinical development programs, four potential therapeutics and two potential vaccines,
all of which were added to our development pipeline based on their potential to represent significant individual market opportunities.
These pre-clinical development programs are at an early stage of development and none of these potential products has obtained regulatory
approval for commercial use and sale in any country and, as such, no revenues have resulted from product sales. Significant additional
investment will be necessary to complete the development of any of our product candidates. Pre-clinical and clinical trial work must
be completed before our potential products could be ready for use within the markets that we have identified. We may fail to develop
any products, obtain regulatory approvals, enter clinical trials or commercialize any products. We do not know whether any of our potential
product development efforts will prove to be effective, meet applicable regulatory standards, obtain the requisite regulatory approvals,
be capable of being manufactured at a reasonable cost or be accepted in the marketplace. We also do not know whether sales, license fees
or related royalties will allow us to recoup any investment we make in the commercialization of our products. The product candidates
we are currently developing are not expected to be commercially viable for at least the next several years and we may encounter unforeseen
difficulties or delays in commercializing our product candidates. In addition, our potential products may not be effective or may cause
undesirable side effects.
Our
product candidates require significant funding to reach regulatory approval assuming positive clinical results. Such funding for our
product candidates may be difficult, or impossible to raise in the public or private markets or through partnerships. If funding or partnerships
are not readily attainable, the development of our product candidates may be significantly delayed or stopped altogether. The announcement
of a delay or discontinuation of development would likely have a negative impact on our share price.
We
may require significant additional financing, and we may not have access to sufficient capital.
We
may require significant additional capital to fund our commercialization efforts and may require additional capital to pursue planned
clinical trials and regulatory approvals. Although we have capital from the License Agreement, we do not anticipate generating significant
revenues from operations in the near future other than from the License Agreement. Moreover, we currently have no committed sources of
capital.
We
may attempt to raise additional funds through public or private financings, collaborations with other pharmaceutical companies or from
other sources, including, without limitation, through at-the-market offerings and issuances of securities. Additional funding may not
be available on terms that are acceptable to us. If adequate funding is not available to us on reasonable terms, we may need to delay,
reduce or eliminate our product development programs or obtain funds on terms less favorable than we would otherwise accept. To the extent
that additional capital is raised through the sale of equity securities or securities convertible into or exchangeable or exercisable
for equity securities, the issuance of those securities would result in dilution to our shareholders. Moreover, the incurrence of debt
financing or the issuance of dividend-paying preferred shares, could result in a substantial portion of our future operating cash flow,
if any, being dedicated to the payment of principal and interest on such indebtedness or the payment of dividends on such preferred shares
and could impose restrictions on our operations and on our ability to make certain expenditures and/or to incur additional indebtedness,
which could render us more vulnerable to competitive pressures and economic downturns.
Our
future capital requirements are substantial and may increase beyond our current expectations depending on many factors, including, but
not limited to, the following:
|
● |
the
duration of changes to and results of our clinical trials for any future products going forward; |
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● |
unexpected
delays or developments in seeking regulatory approvals; |
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● |
the
time and cost involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
|
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unexpected
developments encountered in implementing our business development and commercialization strategies; |
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In
addition, global economic and market conditions, as well as future developments in the credit and capital markets, may make it even more
difficult for us to raise additional financing in the future.
We
are and will be subject to stringent ongoing government regulation for our products and our product candidates, even if we obtain regulatory
approvals for the latter.
The
manufacturing, marketing and sale of Macrilen™ (macimorelin) and our product candidates are and will be subject to strict and ongoing
regulation, even with marketing approval by the FDA and the EC for Macrilen™ (macimorelin). Compliance with such regulation will
be expensive and consume substantial financial and management resources. For example, the EC approval for macimorelin was conditioned
on our agreement to conduct post-marketing follow-up studies to monitor the safety or efficacy of the product. In addition, as clinical
experience with a drug expands after approval because the drug is used by a greater number and more diverse group of patients than during
clinical trials, side effects or other problems may be observed after approval that were not observed or anticipated during pre-approval
clinical trials. In such a case, a regulatory authority could restrict the indications for which the product may be sold or revoke the
product’s regulatory approval.
We
and our contract manufacturers will be required to comply with applicable current Good Manufacturing Practice (“GMP”)
regulations for the manufacture of our current or future products and other regulations. These regulations include requirements relating
to quality assurance, as well as the corresponding maintenance of rigorous records and documentation. Manufacturing facilities must be
approved before we can use them in the commercial manufacturing of a product and are subject to subsequent periodic inspection by regulatory
authorities. In addition, material changes in the methods of manufacturing or changes in the suppliers of raw materials are subject to
further regulatory review and approval.
If
we, or if any future marketing collaborators or contract manufacturers, fail to comply with applicable regulatory requirements, we may
be subject to sanctions including fines, product recalls or seizures and related publicity requirements, injunctions, total or partial
suspension of production, civil penalties, suspension or withdrawals of previously granted regulatory approvals, warning or untitled
letters, refusal to approve pending applications for marketing approval of new products or of supplements to approved applications, complete
withdrawal of a marketing application, exclusion from government healthcare programs, import or export bans or restrictions, and/or criminal
prosecution and penalties. Any of these penalties could delay or prevent the promotion, marketing or sale of a product.
Even
with marketing approval for MacrilenTM (macimorelin), such product approval could be subject to restrictions or withdrawals.
Regulatory requirements are subject to change.
On
December 20, 2017, the FDA granted marketing approval in the U.S. for Macrilen™ (macimorelin) to be used in the diagnosis of patients
with AGHD, and on January 16, 2019, the EC granted marketing approval in Europe for macimorelin for the diagnosis of AGHD. Regulatory
authorities generally approve products for specified indications. If an approval is for a limited indication, this limitation reduces
the size of the potential market for that product. Product approvals, once granted, are subject to continual review and periodic inspections
by regulatory authorities. Our operations and practices are subject to regulation and scrutiny by the U.S. government, as well as governments
of any other countries in which we do business or conduct activities. Later discovery of previously unknown problems or safety issues
and/or failure to comply with domestic or foreign laws, knowingly or unknowingly, can result in various adverse consequences, including,
among other things, a possible delay in the approval or refusal to approve a product, warning or untitled letters, fines, injunctions,
civil penalties, recalls or seizures of products and related publicity requirements, total or partial suspension of production, import
or export bans or restrictions, refusal of the government to renew marketing applications, complete withdrawal of a marketing application,
criminal prosecution and penalties, suspension or withdrawals of previously granted regulatory approvals, withdrawal of an approved product
from the market and/or exclusion from government healthcare programs. Such regulatory enforcement could have a direct and negative impact
on the product for which approval is granted, but also could have a negative impact on the approval of any pending applications for marketing
approval of new drugs or supplements to approved applications.
Because
we operate in a highly regulated industry, regulatory authorities could take enforcement action against us in connection with our licensees’
or collaborators’ businesses or marketing activities for various reasons.
From
time to time, new legislation is passed into law that could significantly change the statutory provisions governing the approval, manufacturing
and marketing of products regulated by the FDA, the EC and other health authorities. In addition, regulations and guidance are often
revised or reinterpreted by health agencies in ways that may significantly affect our business. It is impossible to predict whether further
legislative changes will be enacted, or whether regulations, guidance, or interpretations will change, and what the impact of such changes,
if any, may be.
Healthcare
reform measures could hinder or prevent the commercial success of a product and adversely affect our business.
The
business prospects and financial condition of pharmaceutical and biotechnology companies are affected by the efforts of governmental
and third-party payers to contain or reduce the costs of healthcare. The U.S. government and other governments have shown significant
interest in pursuing healthcare reform and reducing healthcare costs. Any government-adopted reform measures could cause significant
pressure on the pricing of healthcare products and services, including Macrilen™ (macimorelin), both in the U.S. and internationally,
as well as the amount of reimbursement available from governmental agencies and other third-party payers. If reimbursement for Macrilen™
(macimorelin) is substantially less than we expect, our revenue prospects could be materially and adversely impacted.
In
the U.S. and in other jurisdictions there have been, and we expect that there will continue to be, a number of legislative and regulatory
proposals aimed at changing the healthcare system, such as proposals relating to the pricing of healthcare products and services in the
U.S. or internationally, the reimportation of drugs into the U.S. from other countries (where they are then sold at a lower price), and
the amount of reimbursement available from governmental agencies or other third-party payers. Furthermore, the pricing of pharmaceutical
products, in general, and specialty drugs, in particular, has been a topic of concern in the U.S. Congress, where hearings on the topic
have been held, and has been a topic of speeches given by political figures, including the President of the U.S. Additionally, in the
U.S., individual states have also passed legislation and proposed bills that are aimed at drug pricing transparency, which will likely
impact drug pricing. There can be no assurance as to how this scrutiny on pricing of pharmaceutical products will impact future pricing
of Macrilen™ (macimorelin).
The
Patient Protection and Affordable Care Act and the Healthcare and Education Affordability Reconciliation Act of 2010 (collectively,
the “ACA”) has had far-reaching consequences for most healthcare companies, including specialty biopharmaceutical
companies like us. The future of the ACA is, however, uncertain as there have been executive, judicial and congressional challenges to
certain aspects of the ACA. In June 2021, the United States Supreme Court dismissed a challenge to the ACA on the grounds the plaintiffs
did not have standing to attack as unconstitutional the ACA’s minimum essential coverage provision because they had not shown they
had suffered damages from the defendants’ conduct in enforcing the ACA.” Change the last sentence to: “It is unclear
how other such litigation and the healthcare reform efforts of the Biden administration will impact the ACA and our business. It is unclear
how the Supreme Court ruling, other such litigation and the healthcare reform efforts of the Biden administration will impact the ACA
and our business.
In
addition, the Food and Drug Administration Amendments Act of 2007 gives the FDA enhanced post-market authority, including the
authority to require post-marketing studies and clinical trials, labeling changes based on new safety information, and compliance with
risk evaluations and mitigation strategies approved by the FDA. The FDA’s exercise of this authority may result in delays or increased
costs during the period of product development, clinical trials and regulatory review and approval, which may also increase costs related
to complying with new post-approval regulatory requirements, and increase potential FDA restrictions on the sale or distribution of approved
products.
If
we or our licensees market products or interact with health care practitioners in a manner that violates healthcare fraud or abuse laws,
we or our licensees may be subject to civil or criminal penalties, including exclusion from participation in government healthcare programs.
As
a pharmaceutical company, even though we do not provide healthcare services or receive payments directly from or bill directly to Medicare,
Medicaid or other national or third-party payers for our current product, U.S. federal and state healthcare laws and regulations, as
well as certain EU regulatory and government agencies, pertaining to fraud or abuse are and will be applicable to our business. We, and
our licensees, are subject to healthcare fraud and abuse regulation by EU regulatory and government agencies in the countries where we
may seek marketing access, and the U.S. federal government and the states in which we conduct our business.
The
laws that may affect us or affect our licensee’s ability to operate include the federal healthcare program anti-kickback statute,
which prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce, or in
return for, the purchase, lease or order, or arrangement for the purchase, lease or order of any healthcare item or service reimbursable
under Medicare, Medicaid or other federally financed healthcare programs. This statute applies to arrangements between pharmaceutical
manufacturers and prescribers, purchasers and formulary managers. Although there are a number of statutory exceptions and regulatory
safe harbors protecting certain common activities, the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration
intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or a
safe harbor.
Federal
false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal
government, or knowingly making, or causing to be made, a false statement to get a false claim paid. Pharmaceutical companies have been
prosecuted under these laws for a variety of alleged promotional and marketing activities, such as providing free product to customers
with the expectation that the customers would bill federal programs for the product, reporting to pricing services inflated average wholesale
prices that were then used by federal programs to set reimbursement rates, engaging in off-label promotion that caused claims to be submitted
to Medicaid for non-covered off-label uses, and submitting inflated best price information to the Medicaid Drug Rebate Program.
The
Health Insurance Portability and Accountability Act of 1996 also created prohibitions against healthcare fraud and false statements
relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare
benefit program, including private payers. The false statements statute immediately noted above prohibits knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery
of or payment for healthcare benefits, items or services.
In
addition, there has been a recent trend of increased federal and state regulation of payments made to physicians. The ACA, through the
Physician Payment Sunshine Act of 2010, imposed new requirements on manufacturers of drugs, devices, biologics and medical supplies for
which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report
annually to the Centers for Medicare and Medicaid Services (“CMS”), information related to payments or other “transfers
of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals,
and applicable manufacturers and group purchasing organizations to report annually to CMS ownership and investment interests held by
physicians (as defined above) and their immediate family members and payments or other “transfers of value” to such physician
owners and their immediate family members. Manufacturers are required to report such data to the government by the 90th calendar day
of each year.
The
majority of states also have statutes or regulations similar to these federal laws, which apply to items and services reimbursed under
Medicaid and other state programs, or, in several states, apply regardless of the payer. In addition, some states have laws that require
pharmaceutical companies to adopt comprehensive compliance programs. For example, under California law, pharmaceutical companies must
comply with both the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and the PhRMA
Code on Interactions with Healthcare Professionals, as amended. Certain states also mandate the tracking and reporting of gifts, compensation,
and other remuneration paid by us to physicians and other healthcare providers.
Although
compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely
eliminated. Any action against us or our licensees for violation of these laws, even if we successfully defend against it, could cause
us to incur significant legal expenses, cause reputational harm and divert our management’s attention from the operation of our
business. Moreover, achieving and sustaining compliance with EU government and regulatory agencies and applicable U.S. federal and state
laws may prove costly.
Because
of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject
to challenge under one or more of such laws. The ACA also made several important changes to the federal anti-kickback statute, false
claims laws and healthcare fraud statute by weakening the intent requirement under the anti-kickback and healthcare fraud statutes that
may make it easier for the government or whistleblowers to charge such fraud and abuse violations. A person or entity no longer needs
to have actual knowledge of this statute or specific intent to violate it. In addition, the ACA provides that the government may assert
that a claim including items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent
claim for purposes of the false claims statutes. In addition, the ACA increases penalties for fraud and abuse violations. If our past,
present or future operations are found to be in violation of any of the laws described above or other similar governmental regulations
to which we are subject, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment,
exclusion from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations,
any of which could adversely affect our ability to operate our business and negatively impact our financial results.
If
Macrilen™ (macimorelin) does not gain market acceptance, we may be unable to generate significant revenues.
Market
acceptance of Macrilen™ (macimorelin) depends on a number of factors, including, but not limited to, the following:
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advantages and disadvantages of Macrilen™ (macimorelin) relative to current or alternative treatments and tests; |
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If
Macrilen™ (macimorelin) does not gain market acceptance among physicians, patients, healthcare payers and others in the medical
community, who may not accept or utilize Macrilen™ (macimorelin), our ability to generate significant revenues from Macrilen™
(macimorelin) would be limited, and our financial condition could be materially, adversely affected. In addition, if we fail to further
penetrate our core markets and existing geographic markets or to successfully expand our business into new markets, the growth in sales
of Macrilen™ (macimorelin), along with our operating results, could be negatively impacted.
Our
ability to further penetrate our core markets and existing geographic markets in which we compete or to successfully expand our business
into additional countries in Europe, Asia or elsewhere is subject to numerous factors, many of which are beyond our control. Macrilen™
(macimorelin), if successfully commercialized, may compete with a number of drugs, therapies, products and tests currently manufactured
and marketed by major pharmaceutical and other biotechnology companies. Macrilen™ (macimorelin) may also compete with new products
currently under development by others or with products which may be less expensive than Macrilen™ (macimorelin). There can be no
assurance that our efforts to increase market penetration in our core markets and existing geographic markets will be successful. Our
failure to do so could have an adverse effect on our operating results and would likely cause a drop in the share price of our Common
Shares.
We
may expend our limited resources to pursue a particular product or indication and fail to capitalize on other products or indications
for which there may be a greater likelihood of success.
We
are currently focusing our efforts on Macrilen™ (macimorelin) for specific indications and for the six pre-clinical programs announced
in 2021. As a result, we may forego or delay pursuit of opportunities for other potential indications for Macrilen™ (macimorelin),
which there may be a greater likelihood of success or may prove to have greater commercial potential. Research programs to identify new
product candidates or pursue alternative indications for Macrilen™ (macimorelin) require substantial technical, financial and human
resources. These activities – if pursued – may initially show promise in identifying potential product candidates or indications,
yet fail to yield product candidates or indications for further clinical development.
We
may not achieve our projected development goals in the time-frames we announce and expect.
We
may set goals and make public statements regarding the timing of the accomplishment of objectives material to our success, such as the
commencement, enrollment and anticipated completion of clinical trials, anticipated regulatory submission and approval dates and time
of product launch. The actual timing of these events can vary dramatically due to factors such as delays or failures in any clinical
trials, the uncertainties inherent in the regulatory approval process and delays in achieving manufacturing or marketing arrangements
sufficient to commercialize any of our products or product candidates. There can be no assurance that we will make regulatory submissions
or receive regulatory approvals as planned or that we will be able to adhere to our schedule for launching of Macrilen™ (macimorelin)
or any of our future product candidates. If we fail to achieve one or more of these milestones as planned, the share price of our Common
Shares may decline.
If
we fail to obtain acceptable prices or adequate reimbursement for Macrilen™ (macimorelin), our ability to generate revenues will
be diminished.
Our
ability or that of our licensee(s) to successfully commercialize Macrilen™ (macimorelin) will depend significantly on our or their
ability to obtain acceptable prices and the availability of reimbursement to the patient from third-party payers, such as governmental
and private insurance plans. These third-party payers frequently require companies to provide predetermined discounts from list prices,
and they are increasingly challenging the prices charged for pharmaceuticals and other medical products. Macrilen™ (macimorelin)
may not be considered cost-effective, and reimbursement to the patient may not be available or sufficient to allow us or our licensee(s)
to sell our products on a competitive basis. It may not be possible to negotiate favorable reimbursement rates for Macrilen™ (macimorelin).
Adverse pricing and reimbursement conditions would also likely diminish our ability to induce third parties to in-license Macrilen™
(macimorelin).
In
addition, the continuing efforts of third-party payers to contain or reduce the costs of healthcare through various means may limit our
commercial opportunity and reduce any associated revenue and profits. We expect that proposals to implement similar government controls
will continue. The pricing of pharmaceutical products, in general, and specialty drugs, in particular, has been a topic of concern in
the U.S. Congress, where hearings on the topic have been held, and has been a topic of speeches given by political figures, including
the President of the U.S. Specifically, there have been several recent U.S. Congressional inquiries and proposed bills designed to, among
other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and
reform government program reimbursement methodologies for drugs. Furthermore, there is drug pricing reform taking place at the state
level in the U.S. that will impact how pharmaceutical companies can market and sell drug products and at what price. Additionally, third-party
payers are increasingly challenging the price, examining the medical necessity, and reviewing the cost-effectiveness of medical drug
products and medical services, in addition to questioning their safety and efficacy. There can be no assurance as to how this scrutiny
on pricing of pharmaceutical products will impact future pricing of a product or orphan drugs or pharmaceutical products generally. In
addition, increasing emphasis on managed care will continue to put pressure on the pricing of pharmaceutical and biopharmaceutical products.
Cost control initiatives could decrease the price that we or any current or potential collaborators could receive a product and could
adversely affect our profitability. In addition, in the U.S., Canada and many other countries, pricing and/or profitability of some or
all prescription pharmaceuticals and biopharmaceuticals are subject to government control.
If
we or our licensee(s) fail to obtain acceptable prices or an adequate level of reimbursement for Macrilen™ (macimorelin), the sales
of Macrilen™ (macimorelin) would be adversely affected or there may be no commercially viable market for Macrilen™ (macimorelin).
Competition
in our targeted markets is intense, and development by other companies could render Macrilen™ (macimorelin), or any of our future
products, non-competitive.
The
biopharmaceutical field is highly competitive. New products developed by other companies in the industry could render Macrilen™
(macimorelin) or any of our future products uncompetitive or significantly less competitive. Competitors are developing and testing products
and technologies that would compete with Macrilen™ (macimorelin) or any of our future products. Some of these competitive products
may be more effective or have an entirely different approach or means of accomplishing the desired effect than Macrilen™ (macimorelin)
or any of our future products. We expect competition from pharmaceutical and biopharmaceutical companies and academic research institutions
to continue to increase over time. Many of our competitors and potential competitors have substantially greater product development capabilities
and financial, scientific, marketing and human resources than we do.
We
may not obtain adequate protection for Macrilen™ (macimorelin) through our intellectual property.
We
rely heavily on our proprietary information in developing and manufacturing Macrilen™ (macimorelin). Our success depends, in large
part, on our ability to protect our competitive position through patents, trade secrets, trademarks and other intellectual property rights.
We have filed and are pursuing applications for patents and trademarks in many countries. Pending patent applications may not result
in the issuance of patents, and we may not be able to obtain additional issued patents relating to Macrilen™ (macimorelin).
The
laws of some countries do not protect intellectual property rights to the same extent as the laws of the U.S. and Canada. Many companies
have encountered significant problems in protecting and defending such rights in foreign jurisdictions. Many countries, including certain
countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In
addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries,
the patent owner may have limited remedies, which could materially diminish the value of the patent. Moreover, the legal systems of certain
countries, particularly certain developing countries, do not favor the aggressive enforcement of patent and other intellectual property
protection, which makes it difficult to stop and prevent infringement.
Our
patents may be challenged, narrowed, invalidated, held to be unenforceable or circumvented, which could limit our ability to stop competitors
from marketing similar products or limit the length of term of patent protection we may have for Macrilen™ (macimorelin). Changes
in either patent laws or in interpretations of patent laws in the U.S. and other countries may diminish the value of our intellectual
property or narrow the scope of our patent protection for Macrilen™ (macimorelin). The patents issued or to be issued to us for
Macrilen™ (macimorelin) may not provide us with any competitive advantage or protect us against competitors with similar technology.
In addition, it is possible that third parties with products that are very similar to ours will circumvent our patents by means of alternate
designs or processes. We may have to rely on method-of-use, methods of manufacture and/or new-formulation protection for our compounds
in development, and any resulting products, which may not confer the same protection as claims to compounds per se.
In
addition, our patents may be challenged by third parties in patent litigation, which is becoming widespread in the biopharmaceutical
industry. There may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim. There may
also be prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, which may, nonetheless,
ultimately be found to affect the validity or enforceability of a claim. No assurance can be given that our patents would, if challenged,
be held by a court to be valid or enforceable, or that a competitor’s technology or product would be found by a court to infringe
our patents. Our granted patents could also be challenged and revoked in U.S. post-grant proceedings as well as in opposition or nullity
proceedings in certain countries outside the U.S. In addition, we may be required to disclaim part of the term of certain patents. The
costs of these proceedings could be substantial, and it is possible that our efforts could be unsuccessful, resulting in a loss of our
U.S. patent position.
We
also rely on trade secrets and proprietary know-how to protect our intellectual property. If we are unable to protect the confidentiality
of our proprietary information and know-how, the value of our technology and products could be adversely affected. We seek to protect
our unpatented proprietary information in part by requiring our employees, consultants, outside scientific collaborators, and sponsored
researchers and other advisors to enter into confidentiality agreements. These agreements provide that all confidential information developed
or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed
to third parties except in specific circumstances. In the case of our employees, the agreements provide that all of the technology that
is conceived by the individual during the course of employment is our exclusive property. These agreements may not provide meaningful
protection or adequate remedies in the event of unauthorized use or disclosure of our proprietary information. In addition, it is possible
that third parties could independently develop proprietary information and techniques substantially similar to ours or otherwise gain
access to our trade secrets. If we are unable to protect the confidentiality of our proprietary information and know-how, competitors
may be able to use this information to develop products that compete with our products and technologies, which could adversely impact
our business.
We
currently have the right to use certain patents and technologies under license agreements with third parties. Our failure to comply with
the requirements of one or more of our license agreements could result in the termination of such agreements, which could cause us to
terminate the related development program and cause a complete loss of our investment in that program or given market. Inventions claimed
in certain in-licensed patents may have been made with funding from the U.S. government and may be subject to the rights of the U.S.
government, and we may be subject to additional requirements in the event we seek to commercialize or manufacture product candidates
incorporating such in-licensed technology.
As
a result of the foregoing factors, we may not be able to rely on our intellectual property to protect Macrilen™ (macimorelin) in
the marketplace.
We
may infringe the intellectual property rights of others.
Our
commercial success depends significantly on our ability to operate without infringing the patents and other intellectual property rights
of third parties. There could be issued patents of which we are not aware that our products or methods may be found to infringe, or patents
of which we are aware and believe we do not infringe, but which we may ultimately be found to infringe. Moreover, patent applications
and their underlying discoveries are in some cases maintained in secrecy until patents are issued. Because patents can take many years
to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our products
or technologies are found to infringe. Moreover, there may be published pending applications that do not currently include a claim covering
our products or technologies, but, which nonetheless, provide support for a later drafted claim that, if issued, our products or technologies
could be found to infringe.
If
we infringe or are alleged to infringe intellectual property rights of third parties, it will adversely affect our business. Third parties
may own or control these patents or patent applications in the U.S. and abroad. These third parties could bring claims against us or
our collaborators that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial
damages. Further, if a patent infringement suit were brought against us or our collaborators, we or they could be forced to stop or delay
research, development, manufacturing or sales of the product or product candidate that is the subject of the suit.
The
biopharmaceutical industry has produced a proliferation of patents, and it is not always clear to industry participants, including us,
which patents cover various types of products. The coverage of patents is subject to interpretation by the courts, and the interpretation
is not always uniform. In the event of infringement or violation of another party’s patent or other intellectual property rights,
we may not be able to enter into licensing arrangements or make other arrangements at a reasonable cost. Any inability to secure licenses
or alternative technology could result in delays in the introduction of our products or lead to prohibition of the manufacture or sale
of products by us or our partners and collaborators.
Patent
litigation is costly and time consuming and may subject us to liabilities.
If
we become involved in any patent litigation, interference, opposition, re-examination or other administrative proceedings, we will likely
incur substantial expenses in connection therewith, and the efforts of our technical and management personnel will be significantly diverted.
In addition, an adverse determination in litigation could subject us to significant liabilities.
We
may not obtain trademark registrations for our current or future products.
We
have filed applications for trademark registrations, including Macrilen™ (macimorelin), in various jurisdictions, including the
U.S. We may file applications for other possible trademarks for macimorelin. No assurance can be given that any of our trademarks will
be registered elsewhere, or that the use of any registered or unregistered trademarks will confer a competitive advantage in the marketplace.
We
rely on third parties to conduct, supervise and monitor our clinical trials, and those third parties may not perform satisfactorily.
We
rely on third parties such as CROs, medical institutions and clinical investigators to enroll qualified patients and to conduct, supervise
and monitor our clinical trials. Our reliance on these third parties for clinical development activities reduces our control over these
activities. Our reliance on these third parties, however, does not relieve us of our regulatory responsibilities, including ensuring
that our clinical trials are conducted in accordance with GCP guidelines and the investigational plan and protocols contained in an IND
application to the FDA, or a comparable foreign regulatory submission. Furthermore, these third parties may also have relationships with
other entities, some of which may be our competitors. In addition, they may not complete activities on schedule, or may not conduct our
preclinical studies or clinical trials in accordance with regulatory requirements or our trial design. If these third parties do not
successfully carry out their contractual duties or meet expected deadlines, our efforts to obtain regulatory approvals for, and to commercialize,
our products may be delayed or prevented.
We
are dependent on, and rely upon, third parties to perform various functions related to our business, including, but not limited to, development
of some of our product candidates. Our reliance on these relationships poses a number of risks.
Any
difficulties or delays in the commencement or completion, or termination or suspension, of our ongoing or planned clinical trials could
result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
Before
we can initiate clinical trials for our product candidates, we must submit the results of preclinical studies to the FDA or comparable
foreign regulatory authorities along with other information, including information about product candidate chemistry, manufacturing and
controls and our proposed clinical trial protocol, as part of an IND or similar regulatory filing required for authorization to proceed
with clinical development. The FDA or comparable foreign regulatory authorities may require us to conduct additional preclinical studies
for any product candidate before it allows us to initiate clinical trials under any IND or similar regulatory filing, which may lead
to delays and increase the costs of our preclinical development programs. Any such delays in the commencement or completion of the DETECT-trial
evaluating macimorelin for the diagnosis of CGHD, or any other product candidate, could significantly affect our product development
costs.
Further,
conducting clinical trials in foreign countries, as in our ongoing DETECT-trial, presents additional risks that may delay completion
of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a
result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign
regulatory schemes, as well as political and economic risks, including war, relevant to such foreign countries. For example, we have
engaged a CRO to conduct the DETECT-trial outside the United States, including in Russia and Ukraine and clinical trial sites in those
countries are being halted due to the conflict in Ukraine. To date, no patients have been enrolled in these clinical trials. Russia’s
invasion of Ukraine in February 2022 may impact our ability to conduct certain of our trials in the region. This could hinder the completion
of our clinical trials and/or analyses of clinical results, which could materially harm our business.
We
are conducting our DETECT-trial of macimorelin globally and may conduct future clinical trials outside the United States. However, the
FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could
materially harm our business.
In
particular, we have engaged a CRO to conduct our DETECT-trial outside of the United States, including in Russia and Ukraine. As a result
of Russia’s invasion of Ukraine in February 2022, clinical trial sites in Ukraine and the surrounding region are being halted.Furthermore,
the United States and its European allies have imposed significant new sanctions against Russia, including regional embargoes, full blocking
sanctions, and other restrictions targeting major Russian financial institutions. Our ability to conduct clinical trials in Russia, parts
of Ukraine and elsewhere in the region may become restricted under applicable sanctions laws, which would require us to identify alternative
trial sites, which may increase our development costs and delay the clinical development of our product candidates. All of the foregoing
could impede the execution of our clinical development plans, which could materially harm our business.
In
carrying out our operations, we are dependent on a stable and consistent supply of ingredients and raw materials.
There
can be no assurance that we, our contract manufacturers or our licensees, will be able, in the future, to continue to purchase products
from our current suppliers or any other supplier on terms that are favorable or similar to current terms or at all. An interruption in
the availability of certain raw materials or ingredients, or significant increases in the prices we pay for them, could have a material
adverse effect on our business, financial condition, liquidity and operating results.
The
failure to perform satisfactorily by third parties upon which we expect to rely to manufacture and supply products may lead to supply
shortfalls.
We
rely on third parties to manufacture and supply Macrilen™ (macimorelin). We also have or may have certain supply obligations vis-à-vis
our existing and potential licensees, who are or will be responsible for the marketing of Macrilen™ (macimorelin). To be successful,
Macrilen™ (macimorelin) has to be manufactured in commercial quantities in compliance with quality controls and regulatory requirements.
Even though it is our objective to minimize such risk by introducing alternative suppliers to ensure a constant supply at all times,
there are a limited number of contract manufacturers or suppliers that are capable of manufacturing Macrilen™ (macimorelin) or
the materials used in its manufacture. If we are unable to do so ourselves or to arrange for third-party manufacturing or supply of Macrilen™
(macimorelin) or materials, or to do so on commercially reasonable terms, we may not be able to commercialize Macrilen™ (macimorelin)
through our licensees. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured products
ourselves, including reliance on the third party for regulatory compliance, the possibility of breach of the manufacturing agreement
by the third party because of factors beyond our control, and the possibility of termination or non-renewal of the agreement by the third
party, based on its own business priorities, at a time that is costly or inconvenient for us.
We
are subject to intense competition for our skilled personnel, and the loss of key personnel or the inability to attract additional personnel
could impair our ability to conduct our operations.
We
are highly dependent on our management and our clinical, regulatory and scientific staff, the loss of whose services might adversely
impact our ability to achieve our objectives. Recruiting and retaining qualified management and clinical, scientific and regulatory personnel
is critical to our success. Reductions in our staffing levels have eliminated redundancies in key capabilities and skill sets among our
full-time staff, and required us to rely more heavily on outside consultants and third parties. We have been unable to increase the compensation
of our associates to the extent required to remain fully competitive for their services, which increased our employee retention risk.
The competition for qualified personnel in the biopharmaceutical field is intense, and if we are not able to continue to retain qualified
personnel and/or maintain positive relationships with our outside consultants, we may not be able to achieve our strategic and operational
objectives.
We
may be subject to litigation in the future.
We
may, from time to time, be a party to litigation in the normal course of business. Monitoring and defending against legal actions, whether
meritorious, is time-consuming for our management and detracts from our ability to fully focus our internal resources on our business
activities. In addition, legal fees and costs incurred in connection with such activities may be significant and we could, in the future,
be subject to judgments or enter into settlements of claims for significant monetary damages. A decision adverse to our interests could
result in the payment of substantial damages and could have a material adverse effect on our cash flow, results of operations and financial
position.
With
respect to any litigation, our insurance may not reimburse us, or may not be sufficient to reimburse us, for the expenses or losses we
may suffer in contesting and concluding such lawsuit. Substantial litigation costs, including the substantial self-insured retention
that we are required to satisfy before any insurance applies to a claim, unreimbursed legal fees or an adverse result in any litigation
may adversely impact our business, operating results or financial condition.
We
are subject to the risk of product liability claims, for which we may not have or may not be able to obtain adequate insurance coverage.
The
sale and use of Macrilen™ (macimorelin) will involve the risk of product liability claims and associated adverse publicity. Product
liability claims might be made against us directly by patients, healthcare providers or pharmaceutical companies, or others selling,
buying or using our products. We attempt to manage our liability risks by means of insurance. We maintain insurance covering our liability
for our preclinical and clinical studies as well as products liability insurance. However, we may not have or be able to obtain or maintain
sufficient and affordable insurance coverage, including coverage for potentially very significant legal expenses, and without sufficient
coverage any claim brought against us could have a materially adverse effect on our business, financial condition or results of operations.
We
are a holding company, and claims of creditors of our subsidiaries will generally have priority as to the assets of such subsidiaries
over our claims and those of our creditors and shareholders. In addition, our principal operating subsidiary, AEZS Germany, may become
subject to insolvency proceedings if it is illiquid or “over-indebted” in accordance with German law.
Aeterna
Zentaris is a holding company and a substantial portion of our non-cash assets is the share capital of our subsidiaries. AEZS Germany,
our principal operating subsidiary, based in Frankfurt, Germany, holds most of our intellectual property rights. Because Aeterna Zentaris
is a holding company, our obligations to our creditors are structurally subordinated to all existing and future liabilities of our subsidiaries,
which may incur additional or other liabilities and/or obligations. As a result, our rights and the rights of our creditors to participate
in any distribution of the assets of any subsidiary in the event that such subsidiary were to be liquidated or reorganized or in the
event of any bankruptcy or insolvency proceeding relating to or involving such subsidiary, and, therefore, the rights of the holders
of our securities to participate in those assets, are subject to the prior claims of such subsidiary’s creditors. To the extent
that we may be a creditor with recognized claims against any such subsidiary, our claims would still be subject to the prior claims of
our subsidiary’s creditors to the extent that they are secured or senior to those held by us.
Holders
of our securities are not creditors of our subsidiaries. Claims to the assets of our subsidiaries will derive from our own ownership
interest in those operating subsidiaries. Claims of our subsidiaries’ creditors will generally have priority as to the assets of
such subsidiaries over our own ownership interest claims and, therefore, will have priority over the holders of our securities. Our subsidiaries’
creditors may from time to time include general creditors, trade creditors, employees, secured creditors, taxing authorities and creditors
holding guarantees. Accordingly, in the event of any foreclosure, dissolution, winding-up, liquidation or reorganization, or a bankruptcy,
insolvency or creditor protection proceeding relating to us or our property, or any subsidiary, there can be no assurance as to the value,
if any, that would be available to holders of our securities. In addition, any distributions to us by our subsidiaries could be subject
to monetary transfer restrictions in the jurisdictions in which our subsidiaries operate.
German
law, which governs our principal operating subsidiary AEZS Germany, imposes an obligation on the managing director(s) of AEZS Germany
to institute insolvency proceedings of that subsidiary if the managing director(s) concludes that AEZS Germany is insolvent because it
is either illiquid or “over-indebted” in accordance with the provisions of German law.
It
may be difficult for U.S. investors to obtain and enforce judgments against us because of our Canadian incorporation and German presence.
We
are a company existing under the laws of Canada. A number of our directors and officers are residents of Canada or otherwise reside outside
the U.S., and all or a substantial portion of their assets, and a substantial portion of our assets, are located outside the U.S. Consequently,
although we have appointed an agent for service of process in the U.S., it may be difficult for investors in the U.S. to bring an action
against such directors or officers or to enforce against those persons or us a judgment obtained in a U.S. court predicated upon the
civil liability provisions of federal securities laws or other laws of the U.S. Investors should not assume that foreign courts (i) would
enforce judgments of U.S. courts obtained in actions against us or such directors, officers or experts predicated upon the civil liability
provisions of the U.S. federal securities laws or the securities or “blue sky” laws of any state within the U.S. or (ii)
would enforce, in original actions, liabilities against us or such directors, officers or experts predicated upon the U.S. federal securities
laws or any such state securities or “blue sky” laws.
We
are subject to various internal control reporting requirements under applicable Canadian securities laws and the Sarbanes-Oxley Act in
the U.S. We can provide no assurance that we will, at all times in the future, be able to report that our internal controls over financial
reporting are effective.
As
a public company, we are required to comply with Section 404 of the U.S. Sarbanes-Oxley Act of 2002 (“Section 404”)
and National Instrument 52-109 - Certification of Disclosure in Issuers’ Annual and Interim Filings of the Canadian securities
administrators. In any given year, we cannot be certain as to the time of completion of our internal control evaluation, testing and
remediation actions or of their impact on our operations. Upon completion of this process, we may identify control deficiencies of varying
degrees of severity under applicable SEC and Public Company Accounting Oversight Board (U.S.) rules and regulations. As a public company,
we are required to report, among other things, control deficiencies that constitute material weaknesses or changes in internal controls
that, or that are reasonably likely to, materially affect internal controls over financial reporting. A “material weakness”
is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility
that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a
timely basis. If we fail to comply with the requirements of Section 404 or similar Canadian requirements, or if we report a material
weakness, we might be subject to regulatory sanction and investors may lose confidence in our consolidated financial statements, which
may be inaccurate if we fail to remedy such material weakness.
We
have identified a material weakness in our internal control over financial reporting as of December 31, 2021. If we fail to fully remediate
this weakness and maintain proper and effective internal controls, our ability to produce accurate and timely consolidated financial
statements could be impaired, which could harm our operating results and our ability to operate our business or investors’ views
of us and could have a material adverse effect on the price of our common stock.
Management
assessed the effectiveness of our internal control over financial reporting as of December 31, 2021, and based on our assessment using
criteria established in Internal Control — Integrated Framework: 2013, issued by the Committee of Sponsoring Organizations
of the Treadway Commission, management concluded that our internal control over financial reporting was not effective as of December
31, 2021. Management identified a control deficiency that constitutes a material weakness. The material weakness resulted from a failure
in the design and implementation of review controls over the accounting for under license and collaboration agreements under IFRS and
the related revenue recognition. This resulted in a restatement of our previously issued condensed interim consolidated financial statements
as at and for the quarters and year-to-date periods ended March 31, 2021, June 30, 2021 and September 30, 2021, with respect to revenue
recognition on one agreement.
We
have developed and commenced implementation of a remediation plan for this material weakness. While we intend to remediate this material
weakness, we have not completed the implementation of this plan, and we can give no assurance that our current and planned implementation
will remediate this deficiency in our internal control or that additional material weaknesses or significant deficiencies in our internal
control over financial reporting will not be identified in the future. Our failure to implement and maintain effective internal control
over financial reporting could result in errors in our consolidated financial statements that could result in a restatement of our consolidated
financial statements and cause us to fail to meet our reporting obligations. If we cannot in the future favorably assess the effectiveness
of our internal control over financial reporting, investor confidence in the reliability of our financial reports may be adversely affected,
which could have a material adverse effect on the trading price of our common stock.
We
are subject to a broad range of environmental laws and regulations and may be subject to environmental remediation obligations under
such safety and related laws and regulations. The impact of these obligations and the Company’s ability to respond effectively
to them may have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause
the market value of our Common Shares to decline.
We
are subject to a broad range of federal, state, provincial and local environmental laws and regulations in the U.S., Canada and Germany
concerning the environment, safety matters, regulation of chemicals and product safety in the countries where we manufacture and sell
our products or otherwise operate our business. These requirements include, among other matters, regulation of the handling, manufacture,
transportation, storage, use and disposal of materials, including the discharge of pollutants, hazardous substances and waste into the
environment. In the normal course of our business, such substances and waste may be released into the environment, which could cause
environmental or property damage or personal injuries, and which could subject us to remediation obligations regarding contaminated soil
and groundwater, potential liability for damage claims or to social or reputational harm and other similar adverse impacts. Under certain
laws, we may be required to remediate contamination at certain of our properties regardless of whether the contamination was caused by
us or by previous occupants of the property, or by others and at third-party sites where we send waste.
In
recent years, the operations of all companies have become subject to increasingly stringent legislation and regulation related to environmental
protection. Such legislation and regulations are complex and constantly changing. Future events, such as changes in existing laws or
regulations or the enforcement thereof, or the discovery of contamination at our facilities may, among other things, require us to install
additional controls for certain of our emission sources, undertake changes in our manufacturing processes, remediate soil or groundwater
contamination at facilities where such cleanup is not currently required, or to take action to address social expectations or concerns
arising from or relating to such changes and our response to such changes. The cost of such additional compliance or remediation obligations
or responding to such social expectations or concerns may be significant and could have a material adverse effect on our business, financial
condition, cash flows and results of operations and could cause the market value of our Common Shares and/or debt securities to decline.
We
may incur losses associated with foreign currency fluctuations.
Our
operations are, in many instances, conducted in currencies other than our functional currency or the functional currencies of our subsidiaries.
Fluctuations in the value of currencies could cause us to incur currency exchange losses. We do not currently employ a hedging strategy
against exchange rate risk. We cannot assert with any assurance that we will not suffer losses as a result of unfavorable fluctuations
in the exchange rates between the U.S. dollar, the euro, the Canadian dollar and other currencies.
Legislative
actions, new accounting pronouncements and higher insurance costs may adversely impact our future financial position or results of operations.
Changes
in financial accounting standards or implementation of accounting standards may cause adverse, unexpected revenue or expense fluctuations
and affect our financial position or results of operations. New pronouncements and varying interpretations of pronouncements have occurred
with greater frequency and are expected to occur in the future, and we may make or be required to make changes in our accounting policies
in the future. Compliance with changing regulations of corporate governance and public disclosure, notably with respect to internal controls
over financial reporting, may result in additional expenses. Changing laws, regulations and standards relating to corporate governance
and public disclosure are creating uncertainty for companies such as ours, and insurance costs are increasing as a result of this uncertainty.
Data
security breaches may disrupt our operations and adversely affect our operating results.
Our
network security and data recovery measures and those of third parties with which we contract, may not be adequate to protect against
computer viruses, cyber-attacks, breaches, and similar disruptions from unauthorized tampering with our computer systems. The misappropriation,
theft, sabotage or any other type of security breach with respect to any of our proprietary and confidential information that is electronically
stored, including research or clinical data, could cause interruptions in our operations, could result in a material disruption of our
clinical activities and business operations and could expose us to third-party legal claims. Furthermore, we could be required to make
substantial expenditures of resources to remedy the cause of cyber-attacks or break-ins. This disruption could have a material adverse
impact on our business, operating results and financial condition. Additionally, any break-in or trespass of our facilities that results
in the misappropriation, theft, sabotage or any other type of security breach with respect to our proprietary and confidential information,
including research or clinical data, or that results in damage to our research and development equipment and assets could have a material
adverse impact on our business, operating results and financial condition.
Our
business processes personal information, both in connection with clinical activities and our employees. The use of this information is
critical to our operations and innovation, including the development of our products, as well as management of our employees. New and
evolving regulations, such as the European Union General Data Protection Regulation, could bring increased scrutiny of our data management
in the future. Any cyber-attacks or other failure to protect critical and sensitive systems and information could damage our reputation,
prompt litigation or lead to regulatory sanctions, all of which could materially affect our financial condition and results of operation.
Risks
Relating to our Common Shares
Our
share price is volatile, which may result from factors outside of our control.
Our
valuation and share price since the beginning of trading after our initial listings, first in Canada and then in the U.S., have had no
meaningful relationship to current or historical financial results, asset values, book value or many other criteria based on conventional
measures of the value of shares.
Between
January 1, 2021 and December 31, 2021, the closing price of our Common Shares ranged from $0.36 to $3.34 per share on the NASDAQ and
from C$0.64 to C$4.25 per share on the TSX. As of March 24, 2022, the price of our Common Shares on the NASDAQ was $0.375
and C$0.47 on the TSX. Our share price may be affected by developments directly affecting our business and by developments out
of our control or unrelated to us. The stock market generally, and the biopharmaceutical sector in particular, are vulnerable to abrupt
changes in investor sentiment. Prices of shares and trading volume of companies in the biopharmaceutical industry can swing dramatically
in ways unrelated to, or that bear a disproportionate relationship to, operating performance. Our share price and trading volume may
fluctuate based on a number of factors including, but not limited to, the following:
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developments
regarding current or future third-party suppliers and licensee(s); |
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clinical
trial and regulatory developments regarding Macrilen™ (macimorelin); |
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delays
in our anticipated clinical trial development or commercialization timelines; |
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announcements
by us regarding technological, regulatory or other matters; |
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arrivals
or departures of key personnel; |
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governmental
or regulatory action affecting our product candidates and our competitors’ products in the U.S., Canada and other countries; |
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developments
or disputes concerning patent or proprietary rights; |
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actual
or anticipated fluctuations in our revenues or expenses; |
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general
market conditions and fluctuations for the emerging growth and biopharmaceutical market sectors; and |
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economic
conditions in the U.S. or abroad, including the instability due to COVID-19. |
Our
listing on both the NASDAQ and the TSX may increase price volatility due to various factors, including different ability to buy or sell
our Common Shares, different market conditions in different capital markets, and different trading volumes. In addition, low trading
volume may increase the price volatility of our Common Shares. A thin trading market could cause the share price of our Common Shares
to fluctuate significantly more than the stock market as a whole.
We
do not intend to pay dividends in the near future.
To
date, we have not declared or paid any dividends on our Common Shares. As a result, the return on an investment in our Common Shares,
or any of our other securities, will depend upon any future appreciation in value. There is no guarantee that our Common Shares or any
of our other securities will appreciate in value or even maintain the price at which shareholders have purchased them.
Future
issuances of securities and hedging activities may depress the trading price of our Common Shares.
Any
additional or future issuance of securities or convertible securities, including the issuance of securities upon the exercise of stock
options and upon the exercise of warrants or other convertible securities or securities pursuant to which Common Shares are issuable,
could dilute the interests of our existing shareholders, and could substantially decrease the trading share price of our Common Shares.
We
may issue equity securities in the future for a number of reasons, including to finance our operations and business strategy, to satisfy
our obligations upon the exercise of options or warrants, or for other reasons. Our stock option plans generally permit us to have outstanding,
at any given time, stock options that are exercisable for a maximum number of Common Shares equal to 11.4% of all then issued and outstanding
Common Shares.
In
addition, the share price of our Common Shares could also be affected by possible sales of securities by investors who view other investment
vehicles as more attractive means of equity participation in us and by hedging or arbitrage trading activity that may develop involving
our securities. This hedging or arbitrage could, in turn, affect the trading share price of our Common Shares.
In
the event we were to lose our foreign private issuer status as of June 30 of a given financial year, we would be required to comply with
the Securities Exchange Act of 1934 domestic reporting regime, which could cause us to incur additional legal, accounting and other expenses.
In
order to maintain our current status as a foreign private issuer, either (1) a majority of our Common Shares must not be either directly
or indirectly owned of record by residents of the U.S. or (2) (a) a majority of our executive officers and of our directors must not
be U.S. citizens or residents, (b) more than 50 percent of our assets cannot be located in the U.S. and (c) our business must be administered
principally outside the U.S.
In
2021, our management conducted its annual assessment of the various facts and circumstances underlying the determination of our status
as a foreign private issuer and, based on the foregoing, our management has determined that, as of the date of such determination and
as of June 30, 2021, we continued to be a foreign private issuer.
There
can be no assurance, however, that we will remain a foreign private issuer either in 2022 or in future financial years.
If
we were to lose our foreign private issuer status as of June 30 of any given financial year, we would be required to comply with the
Securities Exchange Act of 1934 reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive
than the requirements for foreign private issuers. We may also be required to make changes in our corporate governance practices in accordance
with various SEC rules and the NASDAQ listing standards. The regulatory and compliance costs to us of complying with the reporting requirements
applicable to a U.S. domestic issuer under U.S. securities laws may be higher than the cost we have historically incurred as a foreign
private issuer. As a result, we would expect that a potential loss of foreign private issuer status at some future point in time could
increase our legal, financial reporting and accounting compliance costs, and it is difficult at this time to estimate by how much our
legal, financial reporting and accounting compliance costs may increase in such eventuality.
Our
articles of incorporation contain “blank check” preferred share provisions, which could delay or impede an acquisition of
our company.
Our
articles of incorporation, as amended, authorize the issuance of an unlimited number of “blank check” preferred shares, which
could be issued by our Board without shareholder approval and which may contain liquidation, dividend and other rights equivalent or
superior to our Common Shares. In addition, we have implemented in our constating documents an advance notice procedure for shareholder
approvals to be brought before an annual meeting of our shareholders, including proposed nominations of persons for election to our Board.
These provisions, among others, whether alone or together, could delay or impede hostile takeovers and changes in control or changes
in our management. Any provision of our constating documents that has the effect of delaying or deterring a change in control could limit
the opportunity for our shareholders to receive a premium for their Common Shares and could also affect the price that some investors
are willing to pay for our Common Shares.
Our
business could be negatively affected as a result of the actions of activist shareholders.
Proxy
contests have been waged against many companies in the biopharmaceutical industry over the last few years. If faced with a proxy contest,
we may not be able to successfully respond to the contest, which would be disruptive to our business. Even if we are successful, our
business could be adversely affected by a proxy contest because:
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responding
to proxy contests and other actions by activist shareholders may be costly and time-consuming, and may disrupt our operations and
divert the attention of management and our employees; |
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perceived
uncertainties as to the potential outcome of any proxy contest may result in our inability to consummate potential acquisitions,
collaborations or in-licensing opportunities and may make it more difficult to attract and retain qualified personnel and business
partners; and |
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if
individuals that have a specific agenda different from that of our management, or other members of our board of directors are elected
to our Board as a result of any proxy contest, such an election may adversely affect our ability to effectively and timely implement
our strategic plan and to create value for our shareholders. |
Item
4. |
Information
on the Company |
A. |
History
and development of the Company |
Aeterna
Zentaris Inc. was incorporated on September 12, 1990 under the Canada Business Corporations Act (the “CBCA”)
and continues to be governed by the CBCA. Our registered address is located at 222 Bay St., Suite 3000, Toronto, Ontario, Canada M5K
1E7 c/o Norton Rose Fulbright Canada LLP and we operate another office located at 315 Sigma Drive, Summerville, South Carolina 29486;
our telephone number is (843) 900-3223 and our website is www.zentaris.com.
In
May 2004, we changed our name to Aeterna Zentaris Inc. and on November 17, 2015, we completed 100-to-1 Share Consolidation (reverse stock
split). Our Common Shares commenced trading on a consolidated and adjusted basis on both the NASDAQ and the TSX on November 20, 2015.
We
currently have three wholly-owned direct and indirect subsidiaries: Aeterna Zentaris GmbH (“AEZS Germany”), based in Frankfurt
am Main, Germany and incorporated under the laws of Germany; Zentaris IVF GmbH, a direct wholly-owned subsidiary of AEZS Germany based
in Frankfurt am Main, Germany and incorporated under the laws of Germany; and Aeterna Zentaris, Inc., an entity incorporated in the State
of Delaware with an office in the Charleston, South Carolina area in the U.S.
Our
Common Shares are listed for trading on both the NASDAQ and the TSX under the trading symbol “AEZS”.
Our
agent for service of process and SEC matters in the U.S. is our wholly-owned subsidiary, Aeterna Zentaris, Inc., located at 315 Sigma
Drive, Summerville, South Carolina 29486.
Recent
Developments
For
a complete description of our recent corporate and pipeline developments, refer to “Item 5. - Operating and Financial Review and
Prospects - Key Developments”.
Aeterna
Zentaris is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s
lead product, Macrilen™ (macimorelin), is the first and only U.S. Food and Drug Administration and European Commission approved
oral test indicated for the diagnosis of patients with AGHD. Macimorelin is currently marketed in the U.S. under the tradename Macrilen™
through the license agreement and the amended license agreement (collectively the “Novo Amendment”) with Novo Nordisk Healthcare
AG (“Novo Nordisk” or “Novo”) under which Aeterna Zentaris receives royalties on net sales. According to a commercialization
and supply agreement, MegaPharm Ltd. is seeking regulatory approval and plans to subsequently commercialize macimorelin in Israel and
the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna Zentaris expects that macimorelin
will be marketed in Europe and the United Kingdom as GHRYVELIN™ through a recently established license agreement with Consilient
Health Ltd. (“Consilient Health”) under which Aeterna Zentaris will receive regulatory milestone payments related to agreed-upon
pricing and reimbursement parameters; net sales milestone payments; and royalties, ranging from 10%-20% of net sales, subject to reduction
in certain cases, or sublicense income recorded by Consilient Health. The Company is also leveraging the clinical success and compelling
safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (“CGHD”), an area
of significant unmet need. The Company is actively pursuing business development opportunities for the commercialization of macimorelin
in Asia and the rest of the world. We entered into license and supply agreements with NK Meditech Ltd. (“NK”), a subsidiary
of PharmBio Korea, effective November 30, 2021, and a distribution and commercialization agreement with ER Kim Pharmaceuticals Bulgaria
Food (“ER-Kim”), effective February 1, 2022. The agreements with NK are related to the development and commercialization
of macimorelin for the diagnosis of AGHD and CGHD in the Republic of Korea, while the agreement with ER-Kim is related to the commercialization
of macimorelin for the diagnosis of growth hormone deficiency in children and adults in Turkey and some non-European Union Balkan countries.
The
Company is dedicated to the development of therapeutic assets and has recently taken steps to establish a pre-clinical pipeline to potentially
address unmet medical needs across a number of indications with a focus on rare or orphan indications and with the potential for pediatric
use. To date, we have signed agreements to establish this growing pipeline across a number of indications, including neuromyelitis optica
spectrum disorder (NMOSD), Parkinson’s disease (PD), primary hypoparathyroidism and amyotrophic lateral sclerosis (ALS, Lou Gehrig’s
disease). Additionally, the Company is developing oral prophylactic bacterial vaccines against each of SARS-CoV-2, the virus that causes
COVID-19, and Chlamydia Trachomatis.
Macrilen™
(macimorelin)
Macrilen™
(macimorelin) is a novel orally available peptidomimetic ghrelin receptor agonist that stimulates the secretion of growth hormone by
binding to the ghrelin receptor (GHSR-1a) and has potential uses in both endocrinology and oncology indications. Macrilen™ (macimorelin)
was granted orphan-drug designation by the FDA for use in the diagnosis of growth hormone deficiency (“GHD”).
Competitors
for Macrilen™ (macimorelin) as a product for the diagnosis of AGHD are principally the diagnostic tests currently performed by
endocrinologists, although none of these tests are approved by the FDA for this purpose. The most commonly used diagnostic tests for
GHD are:
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The
Insulin Tolerance Test (“ITT”), which has historically been considered the gold standard for the evaluation of
AGHD because of its high sensitivity and specificity. However, the ITT is inconvenient to both patients and physicians, administered
intravenously (“IV”), and contra-indicated in certain patients, such as patients with coronary heart disease or
seizure disorder, because it requires the patient to experience hypoglycemia to obtain an accurate result. Some physicians will not
induce full hypoglycemia, intentionally compromising accuracy to increase safety and comfort for the patient. Furthermore, administration
of the ITT includes additional costs associated with the patient being closely monitored by a physician for the two- to four-hour
duration of the test, and the test must be administered in a setting where emergency equipment is available and where the patient
can be quickly hospitalized. The ITT is not used for patients with co-morbidities, such as cardiovascular disease, seizure disorder
or a history of brain cancer, or for patients who are elderly and frail, due to safety concerns. |
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The
Glucagon Stimulation Test (“GST”) is considered relatively safe by endocrinologists. The mechanism of action for
this test is unclear. Also, this test takes up to three to four hours. It produces side effects in up to one-third of the patients
with the most common being nausea during and after the test. This test is administered intramuscularly (“IM”). |
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The
growth hormone releasing hormone-arginine stimulation test (“GHRH + ARG”) is an easier test to perform in an office setting
and has a good safety profile, but is considered to be costly to administer compared to the ITT and the GST. GHRH + ARG has been
proposed to be the best alternative to ITT, but GHRH + ARG is no longer available in the U.S. This test is administered through an
IV. |
Oral
administration of Macrilen™ (macimorelin) offers convenience and simplicity over the current GHD tests used, all of which require
either IV or IM administration. Additionally, Macrilen™ (macimorelin) may demonstrate a more favorable safety profile than existing
diagnostic tests, some of which may be inappropriate for certain patient populations (e.g. patients with diabetes mellitus or coronary
heart disease) and have demonstrated a variety of side effects, which Macrilen™ (macimorelin) has not thus far. These factors may
be limiting the use of GHD testing and may potentially enable Macrilen™ (macimorelin) to become the product of choice in evaluating
AGHD. We believe that Macrilen™ (macimorelin) is well-positioned to displace the ITT as the preferred means by endocrinologists
of evaluating AGHD for the following reasons:
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it
is safer and more convenient than the ITT because it does not require the patient to become hypoglycemic; |
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Macrilen™
(macimorelin) is administered orally, while the ITT requires an intravenous injection of insulin; |
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Macrilen™
(macimorelin) is a more robust test than the ITT leading to evaluable test results; |
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Macrilen™
(macimorelin) results are highly reproducible; |
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the
evaluation of AGHD using Macrilen™ (macimorelin) is less time-consuming and labor-intensive than the ITT; and |
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the
evaluation can be conducted in the physician’s office rather than in a hospital-like setting. |
We
believe that approximately 15,000 – 20,000 AGHD tests will be conducted annually, in the U.S., after full market introduction of
Macrilen™ (macimorelin). In addition, based on published information from the U.S. Centers for Disease Control and Prevention,
different scientific publications, Huron, TVG and Navigant Research, we estimate that the total potential U.S. market for AGHD evaluation
is in the range of 28,000 to 43,000 tests per year, excluding the evaluation of patients who have suffered a traumatic brain injury (“TBI”).
In patients with a TBI, GHD is frequent and may contribute to cognitive sequelae and reduction in quality of life. GHD may develop in
approximately 10% to 35% of TBI victims according to published study results. These data support a large upside potential for GHD testing.
Macimorelin
Development History
The
following is a summary of the history of our development of Macrilen™ (macimorelin):
2017
- present
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On
January 4, 2017, we announced that, based on an analysis of top-line data, the confirmatory Phase 3 clinical trial of Macrilen™
(macimorelin) failed to achieve one of its co-primary endpoints. Under the study protocol, the evaluation of AGHD with Macrilen™
(macimorelin) would be considered successful, if the lower bound of the two-sided 95% confidence interval for the primary efficacy
variables was 75% or higher for “percent negative agreement” with the ITT, and 70% or higher for the “percent positive
agreement” with the ITT. While the estimated percent negative agreement met the success criteria, the estimated percent positive
agreement did not reach the criteria for a successful outcome. Therefore, the results did not meet the pre-defined equivalence criteria
which required success for both the percent negative agreement and the percent positive agreement. |
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On
February 13, 2017, we announced that, after reviewing the raw data on which the top-line data were based, we had concluded that Macrilen™
(macimorelin) had demonstrated performance supportive of achieving FDA registration and that we intended to pursue registration.
The announcement set forth the facts on which our conclusion was based. The Company met with the FDA at the end of March 2017 to
discuss this position. |
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On
March 7, 2017, we announced that the Pediatric Committee (“PDCO”) EMA agreed to the Company’s Pediatric Investigation
Plan (“PIP”) for Macrilen™ (macimorelin) and agreed that the Company may defer conducting the PIP until after it
files a Marketing Authorization Application (“MAA”) seeking marketing authorization for the use of Macrilen™ (macimorelin)
for the evaluation of AGHD. |
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On
July 18, 2017, we were provided a Prescription Drug User Fee Amendment date of December 30, 2017 by the FDA. |
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On
November 27, 2017, the EMA accepted our MAA submission for Macrilen™ (macimorelin). |
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On
December 20, 2017, the FDA approved the market authorization for Macrilen™ (macimorelin), to be used in the diagnosis of patients
with AGHD. |
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On
January 16, 2018, the Company, through AEZS Germany, entered into a License Agreement to carry out development, manufacturing, registration,
regulatory and supply chain services for the commercialization of Macrilen™ (macimorelin) in the U.S. and Canada as further
described below. |
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In
the August 2018, Volume 103, Issue 8 edition
of The Journal of Clinical Endocrinology and Metabolism,
the pivotal Phase 3 data from the Macrilen™ (macimorelin) confirmatory trial was published
by Jose M. Garcia, MD, PhD, et al., titled ‘Macimorelin as a Diagnostic Test for Adult GH Deficiency’. |
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On
November 19, 2018, we announced the Committee for Medicinal Products
for Human Use (“CHMP”) of the EMA adopted a positive opinion recommending a marketing
authorization for macimorelin. |
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On
January 16, 2019, we announced that the EC granted marketing authorization for macimorelin. |
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On
December 18, 2019, we announced that the American Association of Clinical Endocrinologists (“AACE”) and the American
College of Endocrinology (“ACE”) published new “Guidelines for Management of Growth Hormone Deficiency in Adults
and Patients Transitioning from Pediatric to Adult Care” (“Guidelines”). Theses AACE/ACE 2019 Guidelines identify
macimorelin as a “shorter and simpler alternative” compared to the traditionally available GHST. |
Macrilen™
(macimorelin) Clinical Program
On
January 28, 2020, we announced the successful completion of patient recruitment for the first pediatric study of macimorelin as a growth
hormone stimulation test for the evaluation of GHD in children. This study, AEZS-130-P01 (“Study P01”), was the first
of two studies as agreed with the EMA in our Pediatric Investigation Plan (the “PIP”) for macimorelin as a GHD diagnostic.
Macimorelin, a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary
gland into the circulatory system. The goal of Study P01 was to establish a dose that can both be safely administered to pediatric patients
and cause a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having GHD. The recommended dose derived
from Study P01 will be evaluated in the pivotal second study, Study P02, on diagnostic efficacy and safety. Study P01 was an international,
multicenter study, which was conducted in Hungary, Poland, Ukraine, Serbia, Belarus and Russia. Study P01 was an open label, group comparison,
dose escalation trial designed to investigate the safety, tolerability, and pharmacokinetic/pharmacodynamic (“PK/PD”)
of macimorelin acetate after ascending single oral doses of macimorelin at 0.25, 0.5, and 1.0 milligram per kilogram body weight in pediatric
patients from two to less than 18 years of age with suspected CGHD. We enrolled a total of 24 pediatric patients across the three cohorts
of the study. Per study protocol, all enrolled patients completed four study visits after successful completion of the screening period.
At Visit 1 and Visit 3, a provocative growth hormone stimulation test was conducted according to the study sites’ local practices.
At Visit 2, the macimorelin test was performed, and following the oral administration of the macimorelin solution, blood samples were
taken at predefined times for PK/PD assessment. Visit 4 was a safety follow-up visit at study end.
The
final study results from Study P01 were published in the second quarter of 2020 indicating positive safety and tolerability data for
use of macimorelin in CGHD, as well as PK/PD data observed in a range as expected from the adult studies.
On
April 7, 2020 the Company announced the decision of the EMA to accept our modification request of our PIP as originally approved in March
2017, which covered the conduct of two pediatric studies and defined relevant key elements in the outline of these studies. We believe
this EMA decision supports the development of one globally harmonized study protocol for test validation, specifically Study P02, which
we expect to be accepted both in Europe and the U.S.
In
late 2020, Aeterna entered into the start-up phase for the clinical safety and efficacy study, AEZS-130-P02 (“Study P02”
or ““DETECT-trial”), evaluating macimorelin for the diagnosis of CGHD. The DETECT-trial is an open-label, single dose,
multicenter and multinational study expected to enroll approximately 100 subjects worldwide, with at least 40 pre-pubertal and 40 pubertal
subjects, and a minimum of 25 subjects expected to be enrolled in the U.S. The study design is expected to be suitable to support a claim
for potential stand-alone testing, if successful. In addition, under the Novo Amendment, Novo and Aeterna agreed that the percentage
of DETECT-trial clinical trial costs that Novo is required to reimburse to Aeterna was adjusted from 70% to 100% of costs up to $11 million
(€9 million), and includes reimbursement of Aeterna’s budgeted internal labor costs. Any additional external jointly approved
DETECT-trial costs incurred over $11 million (€9 million) will be shared equally between Novo and Aeterna. On April 22, 2021, the
U.S. FDA Investigational New Drug Application associated with this clinical trial became active, see: https://clinicaltrials.gov/ct2/show/NCT04786873
and on May 13, 2021, we announced the opening of the first clinical site in the U.S. On January 26, 2022, the Company announced that
it had experienced unavoidable delays in site initiation and patient enrollment due to rise of the Omicron variant in the COVID-19 pandemic.
Further delays may be experienced as a result of the invasion into Ukraine by Russia which may cause volatility, disruption and instability
in general economic conditions and international relations.
Macimorelin
Pre-clinical Program
On
January 13, 2021, we entered into a material transfer agreement with Queensland University to provide macimorelin for the conduct of
preclinical and clinical studies evaluating macimorelin as a therapeutic for the treatment of amyotrophic lateral sclerosis (“ALS”
and commonly known as Lou Gehrig’s disease). Queensland University researchers have filed funding applications to dedicated organizations
in Australia to finance parts of the abbreviated preclinical development program and to conduct a subsequent investigator-initiated clinical
trial to evaluate the safety, tolerability and efficacy of macimorelin as a potential new treatment option for ALS patients. The Company
expects to continue work with Queensland University to conduct proof-of-concept studies with macimorelin in disease specific animal models,
assess alternative formulations and formalize a preclinical development plan. The Company plans to evaluate the development of additional
alternative formulations or administration routes with the goal of ensuring sufficient bioavailability and expects to provide updates
on its progress as results become available.
Macimorelin
Commercialization Program
On
June 25, 2020, we announced that we entered into an exclusive distribution and related quality agreement with MegaPharm Ltd., a leading
Israel-based biopharmaceutical company, for the commercialization in Israel and in the Palestinian Authority of macimorelin, to be used
in the diagnosis of patients with AGHD and in clinical development for the diagnosis of CGHD.
Under
the terms of the agreement, MegaPharm Ltd. will be responsible for obtaining registration to market macimorelin in Israel and the Palestinian
Authority, while the Company will be responsible for manufacturing, product supply, quality assurance and control, regulatory support,
and maintenance of the relevant intellectual property. In June 2021, MegaPharm Ltd. filed an application to the Ministry of Health of
Israel for regulatory approval of macimorelin in Israel.
On
November 16, 2020, the Company announced that it had entered into the Novo Amendment related to the development and commercialization
of macimorelin. Novo is currently marketing macimorelin in the U.S. under the tradename Macrilen™ for the diagnosis of AGHD. Aeterna,
in collaboration with Novo, is currently developing the expanded use of macimorelin for the diagnosis of CGHD, an area of significant
unmet need.
Pursuant
to the Novo Amendment, the Company agreed to grant to Novo additional rights with respect to ownership of the Aeterna Patent Rights and
Trademarks, as defined, and to amend certain responsibilities between Aeterna and Novo with respect to the ongoing development initiatives
for the use of Macrilen™ as a diagnostic in the pediatric indication (the “Pediatric Indication”). Additionally, the
Novo Amendment: reflected the existence of a supply agreement; established total consideration to be provided by Novo as reimbursements
for costs incurred in connection with the development activities related to the Pediatric Indication; provided for a non-refundable upfront
payment of $6.1 million (€5.0 million) to be made by Novo to the Company; and modified future payment obligations, including a reduction
of royalty rates and a waiver by the Company with respect to the $5 million pediatric milestone from the original agreement with Novo.
Per
the Novo Amendment, total consideration to be payable by Novo to the Company as reimbursement for Pediatric Indication development-related
costs was established at approximately $11 million (€9 million) plus 50% of any excess over this amount, limited specifically to
clinical trial expenses, which were estimated to total $11.7 million (€9.9 million) (the “Pediatric Development Consideration”).
The Pediatric Development Consideration was derived from development forecasts that were approved by both the Company and Novo.
As
for the reduction in royalties, the Company agreed to reduce the Net Sales Royalties from 15% to 8.5% for annual net sales of Macrilen™
up to $40 million and to establish a royalty of 15% for annual net sales of Macrilen™ over $40 million.
On
December 7, 2020, the Company entered into an exclusive licensing agreement with Consilient Health Limited (“CH”)
for the commercialization of macimorelin as GHRYVELIN™ in the European Economic Area and the United Kingdom (the “CH License
Agreement”).
Under
the terms of the CH License Agreement, CH agreed to make a non-refundable, non-creditable upfront payment to the Company of $1.2 million
(€1.0 million), which the Company received in January 2021. The Company also is eligible to receive additional consideration, including:
regulatory milestones related to agreed-upon pricing and reimbursement parameters; net sales milestones; and royalties, ranging from
10%-20% of net sales of macmorelin, subject to reduction in certain cases, or sublicense income recorded by CH.
Also
on December 7, 2020, the Company and CH entered into an exclusive supply agreement, pursuant to which the Company agreed to provide the
Licensed Product to CH, with such Licensed Product to be manufactured by third-party manufacturers for a period of ten years, subject
to renewal (the “CH Supply Agreement”). In December 2021, the Department of Health and Social Care in the United Kingdom
approved a list price which triggered a $226 (€0.2 million) pricing milestone payment from CH to the Company.
We
entered into license and supply agreements with NK Meditech Ltd. (“NK”), a subsidiary of PharmBio Korea, effective
November 30, 2021, and a distribution and commercialization agreement with ER Kim Pharmaceuticals Bulgaria Food (“ER-Kim”),
effective February 1, 2022. The agreements with NK are related to the development and commercialization of macimorelin for the diagnosis
of AGHD and CGHD in the Republic of Korea, while the agreement with ER-Kim is related to the commercialization of macimorelin for the
diagnosis of growth hormone deficiency in children and adults in Turkey and some non-European Union Balkan countries.
Pipeline
Expansion Opportunities
Bacterial
Vaccine Platform: Orally active, live-attenuated bacterial vaccine platform with potential application against viruses and bacteria,
such as coronaviruses and chlamydia bacteria
On
February 2, 2021, the Company announced that it had entered into an exclusive option agreement to evaluate a preclinical potential COVID-19
vaccine developed at the University of Wuerzburg. On March 14, 2021, the Company exercised the option to enter into a license agreement
with the University. Pursuant to the terms of the University License Agreement, the Company has been granted an exclusive, world-wide,
license to certain patent applications and know-how owned by the University to research and develop, manufacture, and sell a potential
COVID-19 vaccine using the University’s bacterial vaccine platform technology. The Company has paid an up-front payment under the
University License Agreement and will conduct milestones payments upon achievement of certain development, regulatory, and sales milestones,
as well as a percentage of any sub-licensing revenue received by the Company as well as royalty payments on net sales of the licensed
vaccine products (including for by the Company or its sub-licensees). Pursuant to the University License Agreement, the University granted
the Company an exclusive option for the exclusive use of the Licensed Rights in an undisclosed field. In September 2021, the Company
exercised this option and disclosed the field to be chlamydia. Additionally, the Company has entered into the Research Agreement under
which the Company has engaged the University on a fee-for-service basis to conduct supplementary research activities and preclinical
development studies on the potential vaccines.
The
vaccine technology developed at the University is based on the active live-attenuated bacterial typhoid fever vaccine Salmonella Typhi
Ty21a with an excellent safety profile, as a carrier strain. Our vaccines have the potential to be administered orally, induce mucosal
immunity, induce a response to more than one antigen, and be stored and distributed at 2 to 8°C. We believe that, if there is sufficient
data to advance into human clinical trials, the development program for these vaccines is expected to be abbreviated, as clinical safety
data and manufacturing technology is already available for the underlying vaccine strain.
The
Coronavirus outbreak began in the end of 2019 and in early 2022 was reaching its fourth infection peak worldwide with vaccinated people
getting infected and with booster vaccinations being needed. As of January 12, 2022, there were three vaccines approved in US, and five
in EU. At that time, over 9.5 billion doses had been administered, 59% of the world population had received at least one dose, and 35
million doses were being administered every day. The competition is large with 11 vaccines currently being in clinical studies only in
Europe. Our COVID-19 vaccine candidate is unique in stimulating the mucosal immune system giving the potential to eliminate the virus
when it enters the body, before an infection can occur, and drastically reducing the risk of vaccinated people getting infected and spreading
the virus. In addition, the oral application and its storage stability greatly facilitates distribution and administration. Our next
development steps include evaluating the administration route, dose and immunization scheme; initiating in-vivo immunology experiments
with antigen variant candidates in relevant mice models; conducting virus challenge experiments in immunized transgenic animals; starting
the manufacturing process assessment / development; and conducting pre-clinical safety and toxicology assessments.
Chlamydia
trachomatis is a sexually transmitted bacterium infecting over 130 million subjects annually. In US, the prevalence 2.4 million per year,
the incidence is 4 million per year, and the associated yearly health cost $691 million. The disease can spread to the reproductive tract
eventually inducing infertility, miscarriage, or ectopic pregnancy, which is a life-threatening condition. Additionally, ocular infections
can lead to inclusion conjunctivitis or trachoma, which is the primary source of visual impairment or infectious blindness. While diagnosed
infections can be treated with antibiotics, three quarters of all infections are asymptomatic and currently no vaccine exists to protect
against chlamydia. The potential strengths of our Chlamydia vaccine candidate are the mucosal immunity, oral administration, good stability,
and inexpensive production. Our next development steps include designing and preparing candidate vaccine strains; evaluating administration
route, dose and immunization scheme; and initiating in-vivo immunology experiments with candidate strains in relevant mouse models.
Delayed
Clearance Parathyroid Hormone (“DC-PTH”) Fusion Polypeptides: Potential treatment for chronic hypoparathyroidism
On
March 11, 2021, the Company entered into an exclusive license agreement with The University of Sheffield, United Kingdom, for the intellectual
property relating to parathyroid hormone (“PTH”) fusion polypeptides covering the field of human use, which will initially
be studied by Aeterna for the potential therapeutic treatment of chronic hypoparathyroidism (“HypoPT”). Under the
terms of the exclusive patent and know-how license agreement entered into with the University of Sheffield, Aeterna obtained worldwide
rights to develop, manufacture and commercialize PTH fusion polypeptides covered by the licensed patent applications for all human uses
for an up-front cash payment, and milestone payments to be paid upon the achievement of certain development, regulatory and sales milestones,
as well as low single digit royalty payments on net sales of those products and certain fees payable in connection with sublicensing.
Aeterna will be responsible for the further development, manufacturing, approval, and commercialization of the licensed products. Aeterna
has also engaged the University of Sheffield under a research contract to conduct certain research activities to be funded by Aeterna,
the results of which will be included within the scope of the license granted to Aeterna.
The
researchers at the University of Sheffield have developed a method to increase the serum clearance time of peptides, which the Company
is applying to the development of a treatment for HypoPT. HypoPT is an orphan disease where the PTH level is abnormally low or absent,
with a prevalence per 100 000 of 37 in US, 22 in Denmark, 9.4 in Norway, and 5.3 to 27 in Italy. Standard treatment is calcium and vitamin
D supplementation. The only approved hormone replacement therapy, Natpar/Natpara, is sold by Takedo Pharmaceuticals. It is approved when
standard treatment is insufficient and is administered by daily subcutaneous injections. Longer-acting PTH formulations are expected
to give a more natural PTH level and a better treatment and quality of life for patients with HypoPT. Three competitors working on long-acting
PTH formulations have their products in clinical trials. Ascendis Pharma develops TransCon PTH for daily injections and currently perform
phase III trials. Amolyt Pharma develops their PTH hybrid AZP-3601 for daily injections and completed phase I trials in October 2021.
Extend Biosciences develops their candidate EXT608 for weekly injections and foresee phase I trials starting in Q4 2021. Entera Bio has
an orally administered PTH variant EB612 tested in a phase II study completed in 2015 and is currently evaluating further formulations
for their next clinical trials. In consultation with The University of Sheffield, Aeterna has selected AEZS-150 as the lead candidate
in its DC-PTH program. AEZS-150 is developed to provide a weekly treatment option of chronic hypoparathyroidism in adults. The delayed
clearance time of AEZS-150 is achieved by transposing a principle successfully demonstrated by the University of Sheffield for the human
growth hormone.
AIM
Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum
disorder and Parkinson’s disease
In
January 2021, Aeterna entered into an exclusive patent license and research agreement with the University of Wuerzburg, Germany, for
worldwide rights to develop, manufacture, and commercialize AIM Biologicals for the potential treatment of neuromyelitis optica spectrum
disorder (“NMOSD”). Additionally, the Company has engaged Prof. Dr. Joerg Wischhusen from the University Hospital
in Wuerzburg as well as neuro-immunologist Dr. Michael Levy from the Massachusetts General Hospital in Boston as consultants for scientific
support and advice in the field of inflammatory CNS disorders, autoimmune diseases of the nervous system, and NMOSD. In September 2021,
the Company entered into an additional exclusive license with the University of Wuerzburg for early pre-clinical development towards
the potential treatment of Parkinson’s disease (“PD”).
AIM
Biologicals is based on a natural process during pregnancy, which induces immunogenic tolerance of the maternal immune system to the
partially foreign fetal antigens. Fetal proteins are processed and presented on certain immunosuppressive MHC class I molecules to induce
this tolerance. In an autoimmune disease is the immune system misdirected and targets the body’s own protein. With AIM Biologicals,
we aim to restore the tolerance against such proteins to treat autoimmune diseases.
NMOSD
is an autoimmune disease targeting the protein aquaporin 4 (“AQP4”), primarily found in optic nerves and the spinal
cord. The disease leading to blindness and paralysis has a prevalence of 0.7-10 in 100 000, more common in persons with Asian or African
compared to European ancestors, and 9 times more prevalent among women compared to men. NMOSD progresses in often life-threatening relapses,
which are aggressively treated with high-dose steroids and plasmapheresis.
Until
2019, there was no FDA approved medication so the prevention of relapses and disease progression were treated by off-label use of immunosuppressive
medication such as rituximab, azathioprine and mycophenolate mofetil. More recently three monoclonal antibodies were approved; soliris
inhibiting cleavage of complement protein C5, uplizna depleting B lymphocytes through binding to C19, and enspryng blocking interleukin-6-mediated
inflammatory cascades. Additionally, ultomiris, a long-acting variant of soliris, is currently in phase III trials for NMOSD.
In
addition, other immunosuppressive medications are in clinical trials for this disease. In 2016, TG Therapeutics announced the development
of the antibody ublituximab (TG-1101) for the treatment of NMOSD, although it currently is in phase III trials for relapsing multiple
sclerosis. Lundbeck is also investigating related indications and is performing phase I trials with Lu AG06466. And finally, Aquaporumab
has demonstrated its ability to block the interaction between the autoimmune antibody and AQP4 in preclinical studies.
With
AIM Biologicals, we have the potential to specifically suppress the autoimmune response against aquaporin-4 and thereby treating NMOSD
without suppressing the immune defense against pathogens in general.
Parkinson’s
disease is a neurological disease commonly associated with motoric problems with a slow and fast progression form. It is the second most
common neurodegenerative disease affecting 10 million people worldwide. In US, there are almost 1 million people living with PD and this
is predicted to increase to 1.2 million by 2030. In addition, 60 000 people are diagnosed with PD each year, with the direct and indirect
costs estimated at over $50 billion per year. The hallmark of PD is the neuronal inclusion of mainly α-synuclein protein (αSyn)
associated with the death of dopamine-producing cells. Dopaminergic medication is the mainstay treatment of PD symptoms, but currently
there is no pharmacological therapy to prevent or delay disease progression leading to alternate treatments, such as deep brain stimulation
with short electric bursts, being investigated for the treatment of symptoms.
A
survey of clinical trials under development for PD include: Anavex Life Sciences which is testing their Sigma-1 receptor agonist blarcamesine
in related indications in phase I to III and are planning phase II trials to treat PD; stem-cell therapies are investigated for the regeneration
of damaged neurons by several groups, and International Stem Cell Corporation currently performing a phase I trial. Since αSyn
aggregation has a crucial part in the propagation of PD between cells, Prothena Biosciences and Roche are investigating their αSyn
antibody Prasinemuzab in phase II clinical trials, while AFFiRiS have completed phase I studies with their candidate PD01 stimulating
the immune system to produce such antibodies. With AIM Biologicals we want to induce tolerance for αSyn to stop or slow down the
progression of this degenerative disease.
Macimorelin
Therapeutic: Ghrelin agonist in development for the treatment of amyotrophic lateral sclerosis (Lou Gehrig’s disease)
In
January 2021, the Company entered into a material transfer agreement with the University of Queensland, Australia, to provide macimorelin
for the conduct of pre-clinical and subsequent clinical studies, evaluating macimorelin as a potential therapeutic for the treatment
of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The University of Queensland researchers have filed for supportive
grants to conduct such clinical studies. AEZS and the University are currently in the final steps of negotiating a research agreement.
ALS
is a rare progressive neurological disease primarily affecting the neurons controlling voluntary movement, leading to the disability
to control movements such as walking, talking, and chewing. Most people with ALS die from respiratory failure, usually between 3-5 years
after diagnosis. ALS has a prevalence per 100 000 persons and an incidence per 100,000 person-years of 6.22 and 2.31 in Europe, 5.20
and 2.35 in North America, 3.41 and 1.25 in Latin America, 3.01 and 0.93 in Asian countries excluding Japan, and 7.96 and 1.76 in Japan,
respectively.
Currently
there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. Riluzole was the first treatment
for ALS, it was approved by FDA in 1995, reduces the amount of the neurotransmitter glutamate, is taken orally, and increases life expectance
with 2-3 months. Edaravone is available in Japan since 2016 and in US since 2018, but not marketed in EMA. It is an intravenous mediation
aimed at reducing the progression of ALS with 30% for a specific patient group. The developer Mitsubishi Tanabe Pharma has recently presented
promising 24 weeks results for their oral formulation of edaravone (MT-1186) in a 48-weeks phase III trial. These are the two only FDA
approved treatments of ALS, but various additional drug and non-drug therapies are used to relieve symptoms and improve quality of life.
There
is a great need of further treatment options of ALS and many candidates with various modes of action are being investigated. Advanced
clinical phase treatments include antisense medicine targeting different proteins investigated by Ionis in phase III, Ionis/Biogen in
phase III and II, and Wave Life Sciences/Takeda in phase I/II. Biohaven Pharmaceuticas is investigating verdiperstat, an orally administered
irreversible myeloperoxidase inhibitor, in phase II/III trial. Brainstorm Cell Therapeutics have a cell therapy in phase III trials,
where they are collecting autologous mesenchymal stem cells from the patient, inducing them to secrete growth factors, and injecting
them into the cerebrospinal fluid where they slow down disease progression. Cytokinetics has phase III trials for reldesemtiv, a fast
skeletal muscle troponin activator, expected to lead to increased muscle contractility. The gene therapy, engensis (WM202), from Helixmith
induces expression of the hepatocyte growth factor, which may stimulate nerve regeneration and is currently in phase II trials for ALS
and in phase I to III for further indications. Masitinib is a tyrosine kinase inhibitor being investigated by AB Science which demonstrated
27% decreased disease progression in a phase IIB/III trial, and is currently in a phase III confirmatory trial. Zilucoplan is an investigational
macrocyclic peptide inhibitor of complement component 5 from UCB currently in phase III trials. Clene Nanomedicine has demonstrated the
potential of their orally administered gold nanocrystals CNM-Au8 to reverse neuronal damage, improve energy production, decrease reactive
oxygen species, through the execution of its phase III trials which are expected to be completed in the second half of 2022. Another
potential cure is under development by researchers at the Northwestern University in USA, NU-9 demonstrated in mouse models potential
to decrease misfolding of superoxide dismutase and regeneration of upper motor neurons.
Ghrelin
is a hormone with wide-ranging biological actions, most known for stimulating growth hormone release, which is demonstrating emerging
evidence as therapeutic for ALS. Macimorelin (AEZS-130) is our small molecule ghrelin agonist approved for clinical tests of growth hormone
deficiency. As a ghrelin agonist AEZS-130 has the potential as a treatment for ALS, which is evaluated in this research collaboration.
Geographic
Areas
A
description of the principal geographic areas in which we compete, including a geographical and categorical breakdown of our revenues
in the past three years, is presented in note 25 (Segment information) to our consolidated financial statements included in this Annual
Report on Form 20-F at Item 17.
Seasonality
As
a specialty biopharmaceutical company, the Company does not consider any of its products or services to be seasonal.
Raw
Materials
Raw
materials and supplies are generally available in quantities adequate to meet the needs of our business. We will be dependent on third-party
manufacturers for the pharmaceutical products that we or our licensees will market. An interruption in the availability of certain raw
materials or ingredients, or significant increases in the prices paid by us for them, could have a material adverse effect on our business,
financial condition, liquidity and operating results.
Regulation
of Drug Development
Generally.
Governmental authorities in the U.S., Canada, Europe, and other countries extensively regulate the preclinical and clinical testing,
manufacturing, labeling, storage, record keeping, advertising, promotion, export, marketing, and distribution, among other things, of
pharmaceuticals. Under the laws of the U.S., the countries of the EU, and other countries, we are subject to obligations to ensure that
our clinical trials are conducted in accordance with Good Clinical Practice (“GCP”) guidelines and the investigational
plan and protocols contained in an Investigational New Drug (“IND”) application, or comparable foreign regulatory
submission. Set forth below is a brief summary of the material governmental regulations affecting us in the major markets in which we
intend to market our products and/or promote products that we acquire or in-license or to which we obtain promotional rights.
The
United States. In the U.S., the FDA’s Center for Drug Evaluation and Research (“CDER”) under the Federal
Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act and other federal statutes
and regulations, subjects pharmaceutical products to rigorous review. In order to market and sell a new drug product in the U.S., we
must first test it and send CDER evidence from these tests to prove that the drug is safe and effective for its intended use. In most
cases, these tests include extensive preclinical, clinical, and laboratory tests. A team of CDER physicians, statisticians, chemists,
pharmacologists, and other scientists review the company’s data and proposed labeling. If this independent and unbiased review
establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale. CDER does not test the drug
itself, but it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. Before approving a new
drug or marketing application, the FDA may conduct pre-approval inspections of the developer of the drug (the “sponsor”),
its CRO and/or its clinical trial sites to ensure that clinical, safety, quality control, and other regulated activities are compliant
with GCP, or Good Laboratory Practices (“GLP”), for specific non-clinical toxicology studies. The manufacturing process,
which must be compliant with GMP, and the manufacturing facilities used to produce a product are also subject to ongoing inspection by
the FDA. The FDA may also require confirmatory trials, post-marketing testing, and/or extra surveillance to monitor the effects of approved
products, or place conditions on any approvals that could restrict the commercial applications of a product. Once approved, the labeling,
advertising, promotion, marketing, and distribution of a drug or biologic product must be in compliance with FDA regulatory requirements.
The
first stage required for ultimate FDA approval of a new biologic or drug involves completion of preclinical studies whereby a sponsor
must test new drugs on animals for toxicity. Multiple species are used to gather basic information on the safety and efficacy of the
compound being investigated and/or researched. The FDA regulates preclinical studies under a series of regulations called the current
GLP regulations as well as regulatory requirements found in Part 21 subchapter D of the Code of Federal Regulations. If the sponsor violates
these regulations, the FDA may require that the sponsor replicates those studies or can subject the sponsor to enforcement actions or
penalties as described further below. The sponsor then submits to the FDA an IND application based on the results from the initial testing
that include the drug’s composition and manufacturing, along with a plan for testing the drug on humans. The FDA reviews the IND
to ensure that the proposed studies (clinical trials) do not place human subjects at unreasonable risk of harm. FDA also verifies that
there are adequate informed consent and human subject protections in place.
After
a sponsor submits an IND application, it must wait thirty (30) days before starting a clinical trial to allow the FDA time to review
the prospective study. If the FDA finds a problem, it can order a clinical hold to delay an investigation, or interrupt a clinical trial
if problems occur during the study. After the IND application is in effect, a sponsor may commence human clinical trials. The sponsor
typically conducts human clinical trials in three sequential phases, but the phases may overlap. In Phase 1 trials, the sponsor tests
the product in a small number of patients or healthy volunteers (typically 20-80 healthy volunteers), primarily for safety at one or
more doses. The goal in this phase is to determine what the drug’s most frequent side effects are and, often, how the drug is metabolized
and excreted. Phase 2 studies begin if Phase 1 studies do not reveal unacceptable toxicity. In Phase 2, in addition to safety, the sponsor
evaluates the efficacy of the product in a patient population somewhat larger than Phase 1 trials. The number of subjects in Phase 2
studies typically ranges from a few dozen to about 300. This phase aims to obtain preliminary data on whether a drug works in people
who have a certain disease or condition. At the end of Phase 2, the FDA and sponsor try to come to an agreement on how large-scale studies
in Phase 3 should be done.
Phase
3 studies begin if evidence of effectiveness is shown in Phase 2. Phase 3 trials typically involve additional testing for safety and
clinical efficacy in an expanded population (approx. 300-3,000 volunteers who have the disease or condition) at geographically dispersed
test sites. The sponsor must submit to the FDA a clinical plan, or “protocol”, accompanied by the approval of the institutions
participating in the trials, prior to commencement of each clinical trial. The FDA may order the temporary or permanent discontinuation
of a clinical trial at any time.
In
the case of product candidates for cancer, the initial human testing may be done in patients with the disease rather than in healthy
volunteers. Because these patients are already afflicted with the target disease, such studies may provide results traditionally obtained
in Phase 2 studies. Accordingly, these studies are often referred to as “Phase 1/2” studies as they combine two phases. Even
if patients participate in initial human testing and a Phase 1/2 study is carried out, the sponsor is still responsible for obtaining
all the data usually obtained in both Phase 1 and Phase 2 studies.
The
sponsor must submit to the FDA the results of the preclinical and clinical testing, together with, among other things, detailed information
on the manufacture and composition of the product, in the form of a New Drug Application (an “NDA”) or, in the case
of a biologic, a Biologics License Applications (a “BLA”). In a process that can take a year or more, the FDA reviews
this application and, when and if it decides that adequate data are available to show that the new compound is both safe and effective
for a particular indication and that other applicable requirements have been met, approves the drug or biologic for marketing. The amount
of time taken for this approval process is a function of a number of variables, including the quality of the submission and studies presented
and the potential contribution that the compound will make in improving the treatment of the disease in question.
FDA
provides incentives, such as orphan drug designation or pediatric exclusivity. Orphan-drug designation is granted by the FDA Office
of Orphan Drug Products to novel drugs or biologics that are intended for the safe and effective treatment, diagnosis or prevention of
rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 people but are not expected
to recover the costs of developing and marketing a treatment drug. The designation provides the sponsor with a seven-year period of U.S.
marketing exclusivity if the drug is the first of its type approved for the specified indication, or if it demonstrates superior safety,
efficacy, or a major contribution to patient care versus another drug of its type that was previously granted the designation for the
same indication. We have been granted orphan drug designations for Macrilen™ (macimorelin) for the evaluation of GHD.
Under
the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), newly approved drugs
and indications may benefit from a statutory period of non-patent data exclusivity. The Hatch-Waxman Act provides five-year data exclusivity
to the first applicant to gain approval of an NDA for a new chemical entity (“NCE”), meaning that the FDA has not
previously approved any other drug containing the same active pharmaceutical ingredient, or active moiety. Although protection under
the Hatch-Waxman Act will not prevent the submission or approval of another full NDA, such an NDA applicant would be required to conduct
its own preclinical and adequate, well-controlled clinical trials to demonstrate safety and effectiveness.
The
Hatch-Waxman Act also provides three years of data exclusivity for the approval of new and supplemental NDAs, including Section 505(b)(2)
applications, for, among other things, new indications, dosage forms, routes of administration, or strengths of an existing drug, or
for a new use, if new clinical investigations that were conducted or sponsored by the sponsor are determined by the FDA to be essential
to the approval of the application. This exclusivity, which is sometimes referred to as clinical investigation exclusivity, would not
prevent the approval of another application if the sponsor has conducted its own adequate, well-controlled clinical trials demonstrating
safety and efficacy, nor would it prevent approval of a generic product that did not incorporate the exclusivity-protected changes of
the approved drug product.
The
labeling, advertising, promotion, marketing, and distribution of a drug or biologic product must be in compliance with FDA regulatory
requirements. Failure to comply with applicable requirements can lead to the FDA demanding that production and shipment cease and, in
some cases, that the manufacturer recall products, or to enforcement actions that can include seizures, injunctions, and criminal prosecution.
These failures can also lead to FDA withdrawal of approval to market a product. As long as the requirements are fulfilled and the fees
are paid to FDA the product can stay on the market, there is no renewal procedure.
Canada.
In Canada, the Therapeutic Products Directorate of Health Canada is the Canadian federal authority that regulates pharmaceutical
drugs and medical devices for human use. Prior to being given market authorization, a sponsor must present substantive scientific evidence
of a product’s safety, efficacy, and quality as required by the Food and Drugs Act and other legislation and regulations. The requirements
for the development and sale of pharmaceutical drugs in Canada are substantially similar to those in the U.S., which are described above.
The
European Union. Medicines can be authorized in the EU by using either the centralized authorization procedure (CP), or national authorization
procedures. The EU has implemented a centralized procedure coordinated by the EMA for the approval of human medicines, which results
in a single marketing authorization issued by the EC that is valid across the EU, as well as Iceland, Liechtenstein, and Norway. The
centralized procedure is mandatory for human medicinal products containing a new active substance for the treatment of HIV/AIDS, cancer,
diabetes, neurodegenerative diseases, autoimmune diseases, other immune dysfunctions, viral diseases, or that are designated as orphan
medicinal products. In addition, the CP is required for product types derived, for example, from biotechnological processes or genetic
engineering. For medicines that do not fall within these categories, an applicant has the option of submitting an application for a centralized
marketing authorization to the EMA, as long as the medicine concerned is a significant therapeutic, scientific or technical innovation,
or if its authorization would be in the interest of public health.
There
are two national routes to authorize medicinal products in several EU countries, which are available for investigational drug products
that fall outside the scope of the centralized procedure and result in a national marketing authorization:
● |
Decentralized
procedure. Using the decentralized procedure, a sponsor may apply for simultaneous authorization in more than one EU country
of medicinal products that have not yet been authorized in any EU country and that do not fall within the mandatory scope of the
centralized procedure. After mutual approval national authorizations will be granted separately by each member state involved. Mutual
recognition procedure. In the mutual recognition procedure, a medicine is first authorized in one EU Member State, in accordance
with the national procedures of that country. Following this, further marketing authorizations can be sought from other EU countries
in a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization. |
|
|
● |
National
procedure. If approval is sought independently in only one country, the application for marketing authorization is addressed
directly to the competent authority of the member state. |
Similar
to the U.S., the EMA provides incentives for the development of orphan drugs or for pediatrics. Orphan designation is granted
for diseases affecting less than 5 in 10,000 people in the EU. With the designation, the sponsor benefits from prolonged market exclusivity
(10 years) and fee reductions.
The
pediatric regulation grants pediatric development with a six-month extension of the supplementary protection certificate.
The
EU marketing authorization is valid for five years and is renewable upon application by the MAH. After the renewal the approval is permanently
valid.
Regulation
of Commercial Operations
The
marketing, promotional, and pricing practices of human pharmaceutical manufacturers, as well as the manner in which manufacturers interact
with purchasers and prescribers, are subject to various U.S. federal and state laws, including the federal anti-kickback statute and
the False Claims Act, and state laws governing kickbacks, false claims, unfair trade practices, and consumer protection, and to similar
laws in other countries. In the U.S., these laws are administered by, among others, the Department of Justice (“DOJ”),
the Office of Inspector General of the Department of Health and Human Services, the Federal Trade Commission, the Office of Personnel
Management, and state attorneys general. Over the past several years, the FDA, the DOJ and many other agencies have increased their enforcement
activities with respect to pharmaceutical companies and increased the inter-agency coordination of enforcement activities.
In
the U. S., biopharmaceutical and medical device manufacturers are required to record any transfers of value made to licensed physicians
and teaching hospitals and to disclose such data to the Department of Health and Human Services (“HHS”). In addition
to civil penalties for failure to report transfers of value to physicians or teaching hospitals, there will be criminal penalties if
a manufacturer intentionally makes false statements or excludes information in such reports. The payment data across biopharmaceutical
and medical device companies is posted by the HHS on a publicly available website. Increased access to such data by fraud and abuse investigators,
industry critics and media will draw attention to our collaborations with reported entities and will importantly provide opportunities
to underscore the critical nature of our collaborations for developing new medicines and exchanging scientific information. This national
payment transparency effort coupled with industry commitment to uphold voluntary codes of conduct (such as the PhRMA Code on Interactions
with Healthcare Professionals and PhRMA Guiding Principles Direct to Consumer Advertisements About Prescription Medicines) and rigorous
internal training and compliance efforts will complement existing laws and regulations to help ensure ethical collaboration and truthful
product communications.
The
Canadian Association of Research-Based Pharmaceutical Companies (“Rx & D”) has adopted “Guidelines for Transparency
in Stakeholder Funding” that require member companies to regularly disclose, by means of websites and annual reports, a list of
all stakeholders to which they provide direct funding. The term “stakeholder” is defined in Rx & D’s Code of Ethical
Practices to include “Health Care Professionals”. In the EU, the disclosure code of transfers of value to healthcare professionals
and organizations adopted by the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) requires
all members of EFPIA to disclose transfers of value to healthcare professionals and healthcare organizations beginning in 2016, covering
the relevant transfers in 2015. Each member company will be required to document and disclose: (i) the names of healthcare professionals
and associations that have received payments or other transfers of value and (ii) the amounts or value transferred, and the type of relationship.
For
more information about the regulatory risks associated with our business operations, see “Item 3D. Risk Factors”.
Intellectual
Property - Patents
We
seek to protect our compounds, manufacturing processes, compositions and methods of medical use for our lead drugs and drug candidates
through a combination of patents, trade secrets and know-how. Our patent portfolio consists of approximately six owned and in-licensed
patent families (issued, granted or pending in the U.S., Europe and other jurisdictions). The patent positions of companies in the biotechnology
and pharmaceutical industries are highly uncertain and involve complex legal and factual questions. Therefore, we cannot predict the
breadth of claims, if any, that may be allowed under any of our patent applications, or the enforceability of any of our allowed patents.
See “Item 3.D. Risk Factors - We may not obtain adequate protection for our products through our intellectual property.”
Patents
extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various countries where
patent protection is obtained. The actual protection afforded by a patent, which can vary from country to country, depends on the type
of patent, the scope of its coverage and the availability of legal remedies in the country. In the U.S., the patent term of a patent
that covers an FDA-approved drug may also be eligible for patent term extension, which permits patent term restoration as compensation
for the patent term lost during the FDA regulatory review process. The Hatch-Waxman Act permits a patent term extension of up to five
years beyond the expiration of the patent, in which the patentee may file an application for yearly interim extensions within five years
if the patent will expire and the FDA has not yet approved the NDA. The length of the patent term extension is related to the length
of time the drug is under regulatory review. Patent extension cannot extend the remaining term of a patent beyond a total of 14 years
from the date of product approval and only one patent applicable to an approved drug may be extended.
Similar
provisions are available in Europe and other foreign jurisdictions to extend the term of a patent that covers an approved drug. In these
jurisdictions, however, no interim extensions exist and the marketing approval must be granted before the patent expires. In the future,
we expect to apply for patent term extensions on patents covering those products, outside the U.S. While we anticipate that any such
applications for patent term extensions will likely be granted, we cannot predict the precise length of time for which such patent terms
would be extended in the U.S., Europe or other jurisdictions. If we are not able to secure patent term extensions on patents covering
our products for meaningful periods of additional time, we may not achieve or sustain profitability, which would adversely affect our
business.
In
addition to patent protection, our products may benefit from the market-exclusivity provisions contained in the orphan-drug regulations
or the pediatric-exclusivity provisions or other provisions of the FDA Act, such as a NCE exclusivity or new formulation exclusivity.
Orphan drug regulations provide incentives to pharmaceutical and biotechnology companies to develop and manufacture drugs for the treatment
of rare diseases, currently defined as diseases that exist in fewer than 200,000 individuals in the U.S., or diseases that affect more
than 200,000 individuals in the U.S. but that the sponsor does not realistically anticipate will generate a net profit. Under these provisions,
a manufacturer of a designated orphan drug can seek tax benefits, and the holder of the first FDA approval of a designated orphan product
will be granted a seven-year period of marketing exclusivity for such FDA-approved orphan product. In the U.S., the FDA has the authority
to grant additional data protection for approved drugs where the sponsor conducts specified testing in pediatric or adolescent populations.
If granted, this pediatric exclusivity provides an additional six months which are added to the term of data protection as well as to
the term of any relevant patents, to the extent these protections have not already expired. We may also seek to utilize market exclusivities
in other territories, such as in the EU. There can be no assurance that any of our drug candidates will obtain such orphan drug designation,
pediatric exclusivity, a NCE exclusivity or any other market exclusivity in the U.S., the EU or any other territory, or that we will
be the first to receive the regulatory approval in a given country or territory for such drugs so as to be eligible for any market exclusivity
protection.
Macrilen™
(macimorelin):
We
hold the worldwide rights to macimorelin pursuant to an exclusive license agreement with the French Centre National de la Recherche Scientifique
(CNRS), as licensor, and AEZS Germany, as licensee. The obligation to pay royalties on net sales to CNRS expired in 2021. Macrilen™
is the approved trademark for macimorelin as licensed under the License Agreement for commercialization in the U.S. and Canada.
The
following patents and patent applications relate to macimorelin:
|
● |
U.S.
patent 8,192,719 covers a method of assessing pituitary-related GHD in a human or animal subject comprising an oral administration
of the compound macimorelin and determination of the level of growth hormone in the sample and assessing whether the level of growth
hormone in the sample is indicative of GHD. This patent expires in October 2027. |
|
|
|
|
● |
European
patent 1 984 744 covers a method of assessing pituitary-related GHD by oral administration of macimorelin. This patent expires in
February 2027. |
|
|
|
|
● |
Japanese
patent 4 852 728 covers a method of assessing pituitary-related GHD by oral administration of macimorelin. This patent expires in
February 2027. |
An
invention has been made by inventors of AEZS Germany to use a macimorelin containing composition for the assessment of GHD in adults.
|
● |
A
related U.S. provisional patent applications Serial No. 62/607,866 was filed on December 19, 2017 and Serial No. 62/609,059 was filed
on December 21, 2017. Both are identical and are directed to a method of assessing GHD comprising oral administration of a macimorelin
containing composition and collecting one or two post-administration samples. |
|
|
|
|
● |
The
non-provisional U.S. application 15/993,507 was filed on May 30, 2018 drawing the priority of both provisional applications. The
related U.S. patent 10,288,629 was granted on May 14, 2019, and will expire on May 30, 2038.A Patent Cooperation Treaty (“PCT”)
PCT/EP/2018/085622 application was filed December 18, 2018 drawing the priority of both provisional U.S. applications. In addition
to the method of assessing GHD comprising oral administration of a macimorelin containing composition and collecting one or two post-administration
samples, the PCT application also covers a similar method of assessing GHD using three post-administration samples. On February 24,
2022, following examination of European patent application 18827044.1, a European patent with the title “Method of assessing
growth hormone deficiency comprising oral administration of a macimorelin containing composition and collecting one or two post-administration
samples” has been granted. The patent will be published in European Patent Bulletin on March 23, 2022. The European patent
covers the use of macimorelin according to the label approved by EC to diagnose GHD in adults. The European patent will be validated
in 41 European countries. |
An
invention has been made by inventors of AEZS Germany to use a macimorelin containing composition for the assessment of GHD in children.
The invention is directed to a method comprises providing at least one blood sample, taken from a subject within a range from about 15
to about 100 minutes following an administration of an sufficient amount of macimorelin to induce growth hormone secretion, measuring
the growth hormone level of each blood sample and compare the level with a single threshold value to carry out the diagnosis GHD. The
method of the invention is a stand-alone test.
|
● |
A
related U.S. provisional application Serial No. 63/054,889 was filed July 22, 2020 for the use of macimorelin in assessing growth
hormone deficiency in children. |
|
|
|
|
● |
A
non-provisional U.S. application named “Use of macimorelin in assessing growth hormone deficiency in children” with docket
number 17/375,709 was filed on July 14, 2021, drawing the priority of the provisional application. |
|
|
|
|
● |
An
international PCT application with docket number PCT/EP2020/070691 was filed on July 22, 2020. Based on the PCT application several
national applications have been filed in due time. |
Patent
applications related to the pipeline expansion opportunities and covered by the individual Patent and License Agreements between AEZS
Germany and licensors.
Development
of a COVID-19 vaccine based on a modified Salmonella Typhi Ty21a bacterial strain
|
● |
Our
licensor the University of Wuerzburg has filed a priority patent application at European Patent Office on August 14, 2020, named
“Salmonella vaccine for the treatment of coronavirus”. The patent application with docket number EP20 191142.7 provides
a live-attenuated bacterium of the genus Salmonella comprising a recombinant plasmid encoding a fusion protein, wherein the fusion
protein comprises a coronavirus antigen, and an adjuvant peptide. An international PCT application with docket number PCT/EP2021/072624,
and a national U.S. application with docket number 17/402,014 was filed August 13, 2021. |
Delayed
Clearance Parathyroid Hormone (DC-PTH) Fusion Polypeptide for the treatment of hypoparathyroidism in adults
|
● |
A
priority patent application with docket number GB 1706781.0 has been filed by our licensor The University of Sheffield on April 27,
2017. The patent application provides long-acting parathyroid hormone like fusion polypeptides comprising a receptor polypeptide
and its use in the treatment of hypoparathyroidism and osteoporosis. An international PCT application named “Parathyroid Hormone
Fusion Polypeptide” with docket number PCT/GB2018/051120 was filed April 27, 2018. A national U.S. application with docket
number 16/608,611 has been filed on October 25, 2019 and was published as US 2020/0164033A1 on May 28, 2020. |
AIM
Biologicals: Targeted, highly specific autoimmunity modifying therapeutics
|
● |
Our
licensor the University of Wuerzburg has filed a priority patent application with docket number EP 17172444.6 on May 23, 2017. The
invention relates to targeted immunomodulatory effects of defined peptides in combination with proteins comprising one or more domains
of a non-classical MHC class 1b molecules or in combination with molecules that interfere with the interaction of MHC class 1b molecules
and their receptors. An international PCT application named “Combinations of MHC class 1b molecules and peptides for targeted
therapeutic immunomodulation” with docket number PCT/EP2018/063100 has been filed on May 18, 2018. The application was published
as WO 2018/215340 A1 on November 29, 2018. A national U.S. application with docket number 16/615,188 has been filed on November 20,
2019 and was published as US 2020/0157175A1 on May 21, 2020. |
C. |
Organizational
structure |
Our
corporate structure, the jurisdiction of incorporation of our direct and indirect subsidiaries and the percentage of shares that we held
in those subsidiaries as at December 31, 2021 is depicted in the chart set forth under the caption “Item 4.A. History and development
of the Company”.
D. |
Property,
plant and equipment |
Our
registered address is located in Toronto, Canada. Our largest office is located in Frankfurt, Germany and we have an additional office
in Summerville, South Carolina. We do not own any real property. Effective August 25, 2021, the Company and its landlord mutually agreed
to a one year extension to its existing building lease agreement for its German subsidiary, continuing such terms until March 31, 2023.
The
following table sets forth information with respect to our main facilities as at December 31, 2021.
Location |
|
Use
of space |
|
Square
Footage |
|
Type
of interest |
315
Sigma Drive, Summerville SC 29486 |
|
Occupied
for administration |
|
168 |
|
Leasehold |
Weismüllerstr.
50
D-60314
Frankfurt-am-Main,
Germany |
|
Occupied
for management, R&D, business development and administration |
|
30,343 |
|
Leasehold |
We
believe that our current facilities are adequate to meet our ongoing needs.
Item
4A |
Unresolved
Staff Comments |
Not
required.
Item
5. |
Operating
and Financial Review and Prospects |
Key
Developments
Financing
activities
During
the year ended December 31, 2021, certain warrant holders exercised outstanding warrants to purchase 35,111,187 of our
common shares for gross proceeds of approximately $20.1 million (such exercises, the “2021 Warrant Exercises”).
On
February 19, 2021, the Company completed a bought deal public offering of 20,509,746 common shares at $1.45 per common share, resulting
in aggregate gross proceeds of $29.7 million, less underwriting discounts, commissions and offering expenses of $2.8 million (the “February
2021 Financing”). The Company also granted to the underwriter and placement agent (the “Underwriter”), a 30-day
over-allotment option to purchase up to 3,076,461 additional common shares at a price of $1.45 per common share (the “Underwriter
Option”). In connection with the February 2021 Financing, the Company issued warrants to purchase 1,435,682 common
shares to the Underwriter, with each warrant bearing an exercise price of $1.8125 (the “February 2021 Placement Agent Warrants”).
The February 2021 Placement Agent Warrants expire on February 17, 2026.
On
February 22, 2021, the Underwriter exercised the Underwriter Option and received 3,076,461 common shares in exchange for gross proceeds
to the Company of $4.5 million. Upon exercise of the Underwriter Option, the Underwriter also received an additional 215,352 February
2021 Placement Agent Warrants.
Aggregate
gross proceeds received in connection with the February 2021 Financing totaled $34.2 million, less cash transaction costs of $3.2 million
and non-cash transaction costs, which represent the issue-date fair value of the February 2021 Placement Agent Warrants, of $1.9 million.
The
Company expects to use the net proceeds from the February 2021 Financing for general corporate purposes, including, to
advance, the investigation of further therapeutic uses of Macrilen™ (macimorelin), to expand pipeline development activities,
to further expand commercial activities associated with macimorelin in available territories and to fund a potential
pediatric clinical trial in the E.U. and U.S. for macimorelin.
Macimorelin
Clinical Program
On
January 28, 2020, we announced the successful completion of patient recruitment for the first pediatric study of macimorelin as a growth
hormone stimulation test for the evaluation of GHD in children. This study, AEZS-130-P01 (“Study P01”), was the first
of two studies as agreed with the EMA in our Pediatric Investigation Plan (the “PIP”) for macimorelin as a GHD diagnostic.
Macimorelin, a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary
gland into the circulatory system. The goal of Study P01 was to establish a dose that can both be safely administered to pediatric patients
and cause a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having GHD. The recommended dose derived
from Study P01 will be evaluated in the pivotal second study, Study P02, on diagnostic efficacy and safety. Study P01 was an international,
multicenter study, which was conducted in Hungary, Poland, Ukraine, Serbia, Belarus and Russia. Study P01 was an open label, group comparison,
dose escalation trial designed to investigate the safety, tolerability, and pharmacokinetic/pharmacodynamic (“PK/PD”)
of macimorelin acetate after ascending single oral doses of macimorelin at 0.25, 0.5, and 1.0 milligram per kilogram body weight in pediatric
patients from two to less than 18 years of age with suspected CGHD. We enrolled a total of 24 pediatric patients across the three cohorts
of the study. Per study protocol, all enrolled patients completed four study visits after successful completion of the screening period.
At Visit 1 and Visit 3, a provocative growth hormone stimulation test was conducted according to the study sites’ local practices.
At Visit 2, the macimorelin test was performed, and following the oral administration of the macimorelin solution, blood samples were
taken at predefined times for PK/PD assessment. Visit 4 was a safety follow-up visit at study end.
The
final study results from Study P01 were published in the second quarter of 2020 indicating positive safety and tolerability data for
use of macimorelin in CGHD, as well as PK/PD data observed in a range as expected from the adult studies.
On
April 7, 2020, the Company announced the decision of the EMA to accept our modification request of our PIP as originally approved in
March 2017, which covered the conduct of two pediatric studies and defined relevant key elements in the outline of these studies. We
believe this EMA decision supports the development of one globally harmonized study protocol for test validation, specifically Study
P02, which we expect to be accepted both in Europe and the U.S.
In
late 2020, Aeterna entered into the start-up phase for the clinical safety and efficacy study, AEZS-130-P02 (“Study P02”
or “DETECT-trial”), evaluating macimorelin for the diagnosis of CGHD.The DETECT-trial is an open-label, single dose,
multicenter and multinational study expected to enroll approximately 100 subjects worldwide, with at least 40 pre-pubertal and 40 pubertal
subjects, and a minimum of 25 subjects expected to be enrolled in the U.S. The study design is expected to be suitable to support a claim
for potential stand-alone testing, if successful. In addition, under the Novo Amendment, Novo and Aeterna agreed that the percentage
of DETECT-trial clinical trial costs that Novo is required to reimburse to Aeterna was adjusted from 70% to 100% of costs up to
$11 million (€9 million), and includes reimbursement of Aeterna’s budgeted internal labor costs. Any additional external jointly
approved DETECT-trial costs incurred over $11million (€9 million) will be shared equally between Novo and Aeterna. On April
22, 2021, the U.S. FDA Investigational New Drug Application associated with this clinical trial became active, see: https://clinicaltrials.gov/ct2/show/NCT04786873
and on May 13, 2021, we announced the opening of the first clinical site in the U.S. On January 26, 2022, the Company announced
that it had experienced unavoidable delays in site initiation and patient enrollment due to rise of the Omicron variant in the
COVID-19 pandemic. Our team is diligently working to get more clinical sites up and running with the goal of building momentum and bringing
this study across the finish line while navigating as best as possible through this challenge. However, we have engaged a CRO to conduct
the DETECT-trial outside the United States, including in Russia and Ukraine and clinical trial sites in those countries are being halted
due to the conflict in Ukraine. To date, no patients have been enrolled in these clinical trials. Russia’s invasion of Ukraine
in February 2022 may also impact our ability to conduct certain of our trials in the region. This could hinder the completion of our
clinical trials and/or analyses of clinical results, which could materially harm our business.
Macimorelin
Pre-clinical Program
On
January 13, 2021, we entered into a material transfer agreement with Queensland University to provide macimorelin for the conduct of
preclinical and clinical studies evaluating macimorelin as a therapeutic for the treatment of amyotrophic lateral sclerosis (“ALS”
and commonly known as Lou Gehrig’s disease). Queensland University researchers have filed funding applications to dedicated organizations
in Australia to finance parts of the abbreviated preclinical development program and to conduct a subsequent investigator-initiated clinical
trial to evaluate the safety, tolerability and efficacy of macimorelin as a potential new treatment option for ALS patients. The Company
expects to continue work with Queensland University to conduct proof-of-concept studies with macimorelin in disease specific animal models,
assess alternative formulations and formalize a preclinical development plan. The Company plans to evaluate the development of additional
alternative formulations or administration routes with the goal of ensuring sufficient bioavailability and expects to provide updates
on its progress as results become available.
Macimorelin
Commercialization Program
On
June 25, 2020, we announced that we entered into an exclusive distribution and related quality agreement with MegaPharm Ltd., a leading
Israel-based biopharmaceutical company, for the commercialization in Israel and in the Palestinian Authority of macimorelin, to be used
in the diagnosis of patients with AGHD and in clinical development for the diagnosis of CGHD.
Under
the terms of the agreement, MegaPharm Ltd. will be responsible for obtaining registration to market macimorelin in Israel and the Palestinian
Authority, while the Company will be responsible for manufacturing, product supply, quality assurance and control, regulatory support,
and maintenance of the relevant intellectual property. In June 2021, MegaPharm Ltd. filed an application to the Ministry of Health of
Israel for regulatory approval of macimorelin in Israel.
On
November 16, 2020, the Company announced that it had entered into the Novo Amendment related to the development and commercialization
of macimorelin. Novo is currently marketing macimorelin in the U.S. under the tradename Macrilen™ for the diagnosis of AGHD. Aeterna,
in collaboration with Novo, is currently developing the expanded use of macimorelin for the diagnosis of CGHD, an area of significant
unmet need.
Pursuant
to the Novo Amendment, the Company agreed to grant to Novo additional rights with respect to ownership of the Aeterna Patent Rights and
Trademarks, as defined, and to amend certain responsibilities between Aeterna and Novo with respect to the ongoing development initiatives
for the use of Macrilen™ as a diagnostic in the pediatric indication (the “Pediatric Indication”). Additionally, the
Novo Amendment: reflected the existence of a supply agreement; established total consideration to be provided by Novo as reimbursements
for costs incurred in connection with the development activities related to the Pediatric Indication; provided for a non-refundable upfront
payment of $6.1 million (€5.0 million) to be made by Novo to the Company; and modified future payment obligations, including a reduction
of royalty rates and a waiver by the Company with respect to the $5 million pediatric milestone from the original agreement with Novo.
Per
the Novo Amendment, total consideration to be payable by Novo to the Company as reimbursement for Pediatric Indication development-related
costs was established at approximately $11.1 million (€9 million) plus 50% of any excess over this amount, limited specifically
to clinical trial expenses, which were estimated to total $11.7 million (€9.9 million) (the “Pediatric Development Consideration”).
The Pediatric Development Consideration was derived from development forecasts that were approved by both the Company and Novo.
As
for the reduction in royalties, the Company agreed to reduce the Net Sales Royalties from 15% to 8.5% for annual net sales of Macrilen™
up to $40 million and to establish a royalty of 15% for annual net sales of Macrilen™ over $40 million.
On
December 7, 2020, the Company entered into an exclusive licensing agreement with Consilient Health Limited (“CH”)
for the commercialization of macimorelin (the “Licensed Product”) in the European Economic Area and the
United Kingdom (the “CH License Agreement”).
Under
the terms of the CH License Agreement, CH agreed to make a non-refundable, non-creditable upfront payment to the Company of $1.2 million
(€1.0 million), which the Company received in January 2021. The Company also is eligible to receive additional consideration, including
regulatory milestones related to agreed-upon pricing and reimbursement parameters; net sales milestones; and royalties, ranging from
10%-20% of net sales of macimorelin, subject to reduction in certain cases, or sublicense income recorded by CH.
Also
on December 7, 2020, the Company and CH entered into an exclusive supply agreement, pursuant to which the Company agreed to provide the
Licensed Product to CH, with such Licensed Product to be manufactured by third-party manufacturers for a period of ten years, subject
to renewal (the “CH Supply Agreement”). In December 2021, the Department of Health and Social Care in the
United Kingdom approved a list price which triggered a $226 (€0.2 million) pricing milestone payment from CH to the Company.
We
entered into license and supply agreements with NK Meditech Ltd. (“NK”), a subsidiary of PharmBio Korea, effective
November 30, 2021, and a distribution and commercialization agreement with ER Kim Pharmaceuticals Bulgaria Food (“ER-Kim”),
effective February 1, 2022. The agreements with NK are related to the development and commercialization of macimorelin for the diagnosis
of AGHD and CGHD in the Republic of Korea, while the agreement with ER-Kim is related to the commercialization of macimorelin for the
diagnosis of growth hormone deficiency in children and adults in Turkey and some non-European Union Balkan countries.
Pipeline
Expansion Opportunities
Bacterial
Vaccine Platform: Orally active, live-attenuated bacterial vaccine platform with potential application against viruses and bacteria,
such as coronaviruses and chlamydia bacteria
On
February 2, 2021, the Company announced that it had entered into an exclusive option agreement to evaluate a preclinical potential COVID-19
vaccine developed at the University of Wuerzburg. On March 14, 2021, the Company exercised the option to enter into a license agreement
with the University. Pursuant to the terms of the University License Agreement, the Company has been granted an exclusive, world-wide,
license to certain patent applications and know-how owned by the University to research and develop, manufacture, and sell a potential
COVID-19 vaccine using the University’s bacterial vaccine platform technology. The Company has paid an up-front payment under the
University License Agreement and will conduct milestones payments upon achievement of certain development, regulatory, and sales milestones,
as well as a percentage of any sub-licensing revenue received by the Company as well as royalty payments on net sales of the licensed
vaccine products (including for by the Company or its sub-licensees). Pursuant to the University License Agreement, the University granted
the Company an exclusive option for the exclusive use of the Licensed Rights in an undisclosed field. In September 2021, the Company
exercised this option and disclosed the field to be chlamydia. Additionally, the Company has entered into the Research Agreement
under which the Company has engaged the University on a fee-for-service basis to conduct supplementary research activities and preclinical
development studies on the potential vaccines.
The
vaccine technology developed at the University is based on the active live-attenuated bacterial typhoid fever vaccine Salmonella Typhi
Ty21a with an excellent safety profile, as a carrier strain. Our vaccines have the potential to be administered orally, induce the
mucosal immune system, induce a response to more than one antigen, and be stored and distributed at 2 to 8°C. We believe that, if
there is sufficient data to advance into human clinical trials, the development program for these vaccines is expected to be abbreviated,
as clinical safety data and manufacturing technology is already available for the underlying vaccine strain.
The
Coronavirus outbreak began in the end of 2019 and in early 2022 was reaching its fourth infection peak worldwide with vaccinated people
getting infected and with booster vaccinations being needed. As of January 12, 2022, there were three vaccines approved in US, and five
in EU. At that time, over 9.5 billion doses had been administered, 59% of the world population had received at least one dose, and 35
million doses were being administered every day. The competition is large with 11 vaccines currently being in clinical studies only in
Europe. Our COVID-19 vaccine candidate is unique in stimulating the mucosal immune system giving the potential to eliminate the virus
when it enters the body, before an infection can occur, and drastically reducing the risk of vaccinated people getting infected and spreading
the virus. In addition, the oral application and its storage stability greatly facilitates distribution and administration. Our next
development steps include evaluating the administration route, dose and immunization scheme; initiating in-vivo immunology experiments
with antigen variant candidates in relevant mice models; conducting virus challenge experiments in immunized transgenic animals; starting
the manufacturing process assessment / development; and conducting pre-clinical safety and toxicology assessments.
Chlamydia
trachomatis is a sexually transmitted bacterium infecting over 130 million subjects annually. In US, the prevalence 2.4 million per
year, the incidence is 4 million per year, and the associated yearly health cost $691 million. The disease can spread to the reproductive
tract eventually inducing infertility, miscarriage, or ectopic pregnancy, which is a life-threatening condition. Additionally, ocular
infections can lead to inclusion conjunctivitis or trachoma, which is the primary source of visual impairment or infectious blindness.
While diagnosed infections can be treated with antibiotics, three quarters of all infections are asymptomatic and currently no vaccine
exists to protect against chlamydia. The potential strengths of our chlamydia vaccine candidate are the mucosal immunity, oral administration,
good stability, and inexpensive production. Our next development steps include designing and preparing candidate vaccine strains; evaluating
administration route, dose and immunization scheme; and initiating in-vivo immunology experiments with candidate strains in relevant
mouse models.
On
March 10, 2022, the Company announced the expansion of its research program with the University of Wuerzburg to include the development
of human 3D intestinal tissue models to study infection biology in the gut, the site of Salmonella primary action.
Delayed
Clearance Parathyroid Hormone (“DC-PTH”) Fusion Polypeptides: Potential treatment for chronic hypoparathyroidism
On
March 11, 2021, the Company entered into an exclusive license agreement with The University of Sheffield, United Kingdom, for the intellectual
property relating to parathyroid hormone (“PTH”) fusion polypeptides covering the field of human use, which will initially
be studied by Aeterna for the potential therapeutic treatment of chronic hypoparathyroidism (“HypoPT”). Under the terms of
the exclusive patent and know-how license agreement entered into with the University of Sheffield, Aeterna obtained worldwide rights
to develop, manufacture and commercialize PTH fusion polypeptides covered by the licensed patent applications for all human uses for
an up-front cash payment, and milestone payments to be paid upon the achievement of certain development, regulatory and sales milestones,
as well as low single digit royalty payments on net sales of those products and certain fees payable in connection with sublicensing.
Aeterna will be responsible for the further development, manufacturing, approval, and commercialization of the licensed products. Aeterna
has also engaged the University of Sheffield under a research contract to conduct certain research activities to be funded by Aeterna,
the results of which will be included within the scope of the license granted to Aeterna.
The
researchers at the University of Sheffield have developed a method to increase the serum clearance time of peptides, which the Company
is applying to the development of a treatment for HypoPT. HypoPT is an orphan disease where the PTH level is abnormally low or absent,
with a prevalence per 100 000 of 37 in US, 22 in Denmark, 9.4 in Norway, and 5.3 to 27 in Italy. Standard treatment is calcium and vitamin
D supplementation. In consultation with The University of Sheffield, Aeterna has selected AEZS-150 as the lead candidate in its DC-PTH
program. AEZS-150 is being developed to provide a weekly treatment option of chronic hypoparathyroidism in adults and our next steps
include working with The University of Sheffield to conduct in depth characterization of development candidate (in-vitro and in-vivo);
developing the manufacturing process; and formalizing the pre-clinical development of AEZS-150 in preparation for a potential IND filing
for conducting the first in-human clinical study.
AIM
Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum
disorder and Parkinson’s disease
In
January 2021, Aeterna entered into an exclusive patent license and research agreement with the University of Wuerzburg, Germany, for
worldwide rights to develop, manufacture, and commercialize AIM Biologicals for the potential treatment of NMOSD. Additionally, the Company
has engaged Prof. Dr. Joerg Wischhusen from the University Hospital in Wuerzburg as well as neuro-immunologist Dr. Michael Levy from
the Massachusetts General Hospital in Boston as consultants for scientific support and advice in the field of inflammatory CNS disorders,
autoimmune diseases of the nervous system, and NMOSD. In September 2021, the Company entered into an additional exclusive license with
the University of Wuerzburg for early pre-clinical development towards the potential treatment of Parkinson’s disease.
AIM
Biologicals is based on a natural process during pregnancy, which induces immunogenic tolerance of the maternal immune system to the
partially foreign fetal antigens. Fetal proteins are processed and presented on certain immunosuppressive major histocompatibility complex
class I molecules to induce this tolerance. In an autoimmune disease is the immune system misdirected and targets the body’s
own protein. With AIM Biologicals, we aim to restore the tolerance against such proteins to treat autoimmune diseases.
NMOSD
is an autoimmune disease targeting the protein aquaporin 4, primarily found in optic nerves and the spinal cord. The disease leading
to blindness and paralysis has a prevalence of 0.7-10 in 100,000, more common in persons with Asian or African compared to European ancestors,
and nine times more prevalent among women compared to men. NMOSD progresses in often life-threatening relapses, which are aggressively
treated with high-dose steroids and plasmapheresis. Our pre-clinical plans include conducting in-vitro and in-vivo assessments
to select an AIM Biologicals-based development candidate; and manufacturing process development for the selected candidate.
Parkinson’s
disease is a neurological disease commonly associated with motoric problems with a slow and fast progression form. It is the second most
common neurodegenerative disease affecting 10 million people worldwide. The hallmark of PD is the neuronal inclusion of mainly α-synuclein
protein (αSyn) associated with the death of dopamine-producing cells. Dopaminergic medication is the mainstay treatment of PD symptoms,
but currently there is no pharmacological therapy to prevent or delay disease progression leading to alternate treatments, such as deep
brain stimulation with short electric bursts, being investigated for the treatment of symptoms. For the development of AIM Biologicals
as potential PD therapeutics, Aeterna plans to utilize, among others, an innovative animal model on neurodegeneration by α-synuclein-specific
T cells in AAV-A53T-α-synuclein Parkinson’s disease mice, which has recently been published by University of Wuerzburg researchers.
Our next steps include designing and producing antigen-specific AIM Biologics molecules for the potential treatment of Parkinson’s
disease; and conducting in-vitro and in-vivo assessments in relevant Parkinson’s disease models.
Macimorelin
Therapeutic: Ghrelin agonist in development for the treatment of amyotrophic lateral sclerosis (Lou Gehrig’s disease)
In
January 2021, the Company entered into a material transfer agreement with the University of Queensland, Australia, to provide macimorelin
for the conduct of pre-clinical and subsequent clinical studies, evaluating macimorelin as a potential therapeutic for the treatment
of ALS. The University of Queensland researchers have filed for supportive grants to conduct such clinical studies. AEZS and the University
are currently in the final steps of negotiating a research agreement.
ALS
is a rare progressive neurological disease primarily affecting the neurons controlling voluntary movement, leading to the disability
to control movements such as walking, talking, and chewing. Most people with ALS die from respiratory failure, usually between 3-5 years
after diagnosis. Currently there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. Ghrelin
is a hormone with wide-ranging biological actions, most known for stimulating growth hormone release, which is demonstrating emerging
evidence as therapeutic for ALS. As a ghrelin agonist, macimorelin has the potential as a treatment for ALS, which is evaluated in this
research collaboration. Our next steps include working with the University of Queensland to conduct proof-of-concept studies with macimorelin
in disease-specific animal models, assessing alternative formulations and formalizing a pre-clinical development plan.
Changes
in personnel and advisors
On
May 3, 2021, the Company announced the addition of Michael Teifel, Ph.D. as Senior Vice President, Non-Clinical Development and Chief
Scientific Officer to drive forward our pre-clinical research initiatives. In the second quarter of 2021, Prof. Dr. Joerg Wischhusen
(Wuerzburg University) and Dr. Michael Levy, MD, PhD were engaged by the Company as a scientific consultant to support
the development of the AIM Biologicals in NMOSD. Dr. Thomas Rudel (Wuerzburg University) was engaged by the Company in September 2021
as a scientific consultant to support development of the salmonella-based vaccine platform for coronavirus and chlamydia vaccines. Effective
January 24, 2022, Mr. Giuliano La Fratta joined the Company as the Senior Vice President, Chief Financial Officer, replacing Ms. Leslie
Auld.
Nasdaq
Letters
On
July 28, 2021, we received a letter from the Listing Qualifications Staff of the Nasdaq, notifying us that during the 30 consecutive
business days prior to the date of the letter, the closing bid price of our common shares was below $1.00 per share and, therefore, we
did not meet the requirement for continued listing on Nasdaq as required by Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were granted a grace period of 180 calendar days, through January 24, 2022.
On January 26, 2022, we announced that the Listing Qualifications Staff of the Nasdaq had notified the Company that it has been granted
an additional 180 calendar day period, through July 26, 2022, to comply with the US$1.00 minimum bid price requirement for continued
listing on the Nasdaq. If at any time before July 26, 2022, the bid price for the Company’s common shares closes at or above US$1.00
per share for a minimum of 10 consecutive business days (and generally not more than 20 consecutive business days, in Nasdaq’s
discretion), it is expected that Nasdaq would provide formal notice that the Company has regained compliance with the bid price requirement.
The Company may choose to implement a reverse stock split before July 26, 2022 in order to regain compliance. In the event the Company
does not provide, during the 180-day grace period, evidence to demonstrate compliance with Bid Price Rule, it is expected that Nasdaq
would notify the Company that its shares are subject to delisting. At such time, the Company may appeal such determination to a Nasdaq
Hearings Panel (the “Panel”) and it is expected that the Company’s securities would continue to be listed and available
to trade on Nasdaq at least pending the completion of the appeal process. There can be no assurance that any such appeal would be successful
or that the Company would be able to comply with the terms of any extension that may be granted by the Panel. There is no assurance that
we will regain compliance with the Bid Price Rule in the future, and therefore there can be no assurance that our common shares will
remain listed on Nasdaq. The aforementioned notification from the Nasdaq does not impact the Company’s listing status on the TSX.
As
of the date of this Annual Report on Form 20-F, the Company’s closing bid price was below $1.00. See “Item 3.D. Risk factors—Our
Common Shares may be delisted from the NASDAQ or the TSX, which could affect their market price and liquidity. If our Common Shares were
to be delisted, investors may have difficulty in disposing their Common Shares.”
Settlement
of Class-Action Lawsuit
On
March 9, 2020, the Company settled the previously disclosed class-action lawsuit against it pending in the U.S. District Court for the
District of New Jersey. This settlement was approved by the U.S. District Court for the District of New Jersey on June 3, 2021. The settlement
payment was funded entirely by the Company’s insurers. As no appeals were filed within the 30-day appeal period, this matter is
fully and finally settled.
Extension
of German building lease
Effective
August 25, 2021, the Company and its landlord mutually agreed to a one year extension to its existing building lease agreement for its
German subsidiary, continuing such terms until March 31, 2023.
Exposure
to Epidemic or Pandemic Outbreak
Coronavirus,
or COVID-19, a contagious disease that was characterized by the World Health Organization as a pandemic in early 2020, continues to affect
the global community. The significant spread of COVID-19 resulted in a widespread health crisis and has had adverse effects on national
economies generally, on the markets that we serve, on our operations and on the market price of our Common Shares.
The
spread of COVID-19 may continue to impact our operations, including the potential interruption of our clinical trial activities and of
our supply chain. For example, the rise in the Omicron variant in the COVID-19 pandemic has caused delays in site initiation and patient
enrollment in our Phase 3 DETECT clinical trial for diagnostic use in childhood-onset growth hormone deficiency. Additionally, sales
activities for Macrilen™ in the US may be impacted due to delays of diagnostic activities on AGHD in the US. Further, the COVID-19
pandemic may also cause some patients to be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if
quarantines impede patient movement or interrupt healthcare services, which would delay our ability to conduct clinical trials or release
clinical trial results on a timely basis and could delay our ability to obtain regulatory approval and commercialize our product candidates.
The spread of an infectious disease, including COVID-19, may also result in the inability of our suppliers to deliver components or raw
materials on a timely basis or at all. In addition, hospitals may reduce staffing and reduce or postpone certain treatments in response
to the spread of an infectious disease. Such events may result in a period of business disruption and, in reduced operations, doctors
or medical providers may be unwilling to participate in our clinical trials, any of which could materially affect our business, financial
condition or results of operations.
Given
this rapidly evolving situation, the duration, scope and impact on our business operations, clinical studies and financial results cannot
at this time be fully determined or quantified. Aeterna Zentaris has developed protocols and procedures should they be required to deal
with any potential epidemics and pandemics and has implemented these protocols and procedures to address the current COVID-19 pandemic.
Despite appropriate steps being taken to mitigate such risks, there can be no assurance that existing policies and procedures will ensure
that the Company’s operations will not be adversely affected. The COVID-19 pandemic has resulted in a widespread health crisis
that has adversely affected the economies and financial markets of many regions and countries. There can be no assurance that a disruption
in financial markets, regional economies and the world economy would not negatively affect Aeterna Zentaris’ access to capital
or its financial performance.
Uncertain
factors, including the duration of the outbreak, the severity of the disease and the actions to contain or treat its impact, could impair
our operations including, among other things, employee mobility and productivity, availability of our facilities, conduct of our clinical
trials and the availability and the productivity of third-party product and service suppliers. Please see the Risk Factor entitled “The
economic effects of a pandemic, epidemic or outbreak of an infectious disease could adversely affect our operations or the market price
of our Common Shares”.
Russia/Ukraine Conflict
Conducting clinical trials
in foreign countries, as in our ongoing DETECT-trial, presents additional risks that may delay completion of our clinical trials. These
risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare
services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political
and economic risks, including war, relevant to such foreign countries. For example, we have engaged a CRO to conduct the DETECT-trial
outside the United States, including in Russia and Ukraine and clinical trial sites in those countries are being halted due to the conflict
in Ukraine. To date, no patients have been enrolled in these clinical trials. Russia’s invasion of Ukraine in February 2022 may
impact our ability to conduct certain of our trials in the region. This could hinder the completion of our clinical trials and/or analyses
of clinical results, which could materially harm our business.
In particular, we have engaged a CRO
to conduct our DETECT-trial outside of the United States, including in Russia and Ukraine. As a result of Russia’s invasion of
Ukraine in February 2022, clinical trial sites in Ukraine and the surrounding region are being halted. Furthermore, the United States
and its European allies have imposed significant new sanctions against Russia, including regional embargoes, full blocking sanctions,
and other restrictions targeting major Russian financial institutions. Our ability to conduct clinical trials in Russia, parts of Ukraine
and elsewhere in the region may become restricted under applicable sanctions laws, which would require us to identify alternative trial
sites, which may increase our development costs and delay the clinical development of our product candidates. All of the foregoing could
impede the execution of our clinical development plans, which could materially harm our business.
A.
Operating Results
Consolidated
Statements of Comprehensive Loss Information
| |
Three
months ended December 31, | | |
Years
ended December 31, | |
(in
thousands, except share and per share data) | |
2021 | | |
2020 | | |
2021 | | |
2020 | | |
2019 | |
| |
$ | | |
$ | | |
$ | | |
$ | | |
$ | |
Revenues | |
| | | |
| | | |
| | | |
| | | |
| | |
License fees | |
| 361 | | |
| 856 | | |
| 1,670 | | |
| 911 | | |
| 74 | |
Development services | |
| 528 | | |
| — | | |
| 3,337 | | |
| — | | |
| — | |
Product sales | |
| — | | |
| 1,354 | | |
| — | | |
| 2,370 | | |
| 129 | |
Royalty income | |
| 21 | | |
| 20 | | |
| 68 | | |
| 67 | | |
| 45 | |
Supply chain | |
| 46 | | |
| 136 | | |
| 185 | | |
| 304 | | |
| 284 | |
Total
revenues | |
| 956 | | |
| 2,366 | | |
| 5,260 | | |
| 3,652 | | |
| 532 | |
Operating expenses | |
| | | |
| | | |
| | | |
| | | |
| | |
Cost of sales | |
| 18 | | |
| 1,410 | | |
| 90 | | |
| 2,317 | | |
| 410 | |
Research and development expenses | |
| 1,863 | | |
| 626 | | |
| 6,574 | | |
| 1,506 | | |
| 1,837 | |
General and administrative expenses | |
| 1,779 | | |
| 1,314 | | |
| 5,916 | | |
| 4,759 | | |
| 6,615 | |
Selling expenses | |
| 427 | | |
| 404 | | |
| 1,351 | | |
| 1,134 | | |
| 1,214 | |
Restructuring costs | |
| — | | |
| — | | |
| — | | |
| — | | |
| 507 | |
Gain on modification of building lease | |
| — | | |
| — | | |
| — | | |
| (219 | ) | |
| — | |
Impairment of right of use asset | |
| — | | |
| — | | |
| — | | |
| — | | |
| 22 | |
(Reversal)
impairment of other asset | |
| — | | |
| (139 | ) | |
| — | | |
| (139 | ) | |
| 169 | |
Total
operating expenses | |
| 4,087 | | |
| 3,615 | | |
| 13,931 | | |
| 9,358 | | |
| 10,774 | |
Loss
from operations | |
| (3,131 | ) | |
| (1,249 | ) | |
| (8,671 | ) | |
| (5,706 | ) | |
| (10,242 | ) |
Gain due to changes in foreign currency
exchange rates | |
| 257 | | |
| 335 | | |
| 215 | | |
| 572 | | |
| 87 | |
Change in fair value of warrant liability | |
| — | | |
| — | | |
| — | | |
| 1,147 | | |
| 4,518 | |
Other finance costs | |
| — | | |
| (2 | ) | |
| (21 | ) | |
| (736 | ) | |
| (593 | ) |
Net
finance income | |
| 257 | | |
| 333 | | |
| 194 | | |
| 983 | | |
| 4,012 | |
Loss before income taxes | |
| (2,874 | ) | |
| (916 | ) | |
| (8,477 | ) | |
| (4,723 | ) | |
| (6,230 | ) |
Income tax (expense)
recovery | |
| (20 | ) | |
| (395 | ) | |
| 109 | | |
| (395 | ) | |
| 188 | |
Net loss | |
| (2,894 | ) | |
| (1,311 | ) | |
| (8,368 | ) | |
| (5,118 | ) | |
| (6,042 | ) |
Other comprehensive loss | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation adjustments | |
| (93 | ) | |
| (657 | ) | |
| 367 | | |
| (1,139 | ) | |
| 83 | |
Actuarial (loss)
gain on defined benefit plans | |
| (3,725 | ) | |
| 15 | | |
| (3,592 | ) | |
| (650 | ) | |
| (1,068 | ) |
Comprehensive
loss | |
| (6,712 | ) | |
| (1,953 | ) | |
| (11,593 | ) | |
| (6,907 | ) | |
| (7,027 | ) |
Net
loss per share (basic) | |
| (0.02 | ) | |
| (0.02 | ) | |
| (0.07 | ) | |
| (0.12 | ) | |
| (0.35 | ) |
Net
loss per share (diluted) | |
| (0.02 | ) | |
| (0.02 | ) | |
| (0.07 | ) | |
| (0.12 | ) | |
| (0.35 | ) |
Our
operating and financial review and prospects should be read in conjunction with our consolidated financial statements, accompanying notes
and other information appearing in this Annual Report.
2021
compared with 2020
Fourth
Quarter
Revenues
Our
total revenue for the three-month period ended December 31, 2021 was $1.0 million as compared with $2.4 million for the same period in
2020, representing a decrease of $1.4 million, primarily due to $1.4 million decline in product sales of macimorelin to its licensees
(as no product sales were generated in 2021), $0.5 million decline in license fees offset by $0.5 million increase in development services
(as further discussed below).
In
the fourth quarter of 2021, the Company restated its previously reported condensed consolidated interim financial statements for the
three-month period ended March 31, 2021 and the three-month and six-month periods ended June 30, 2021 and three-month and nine-month
periods ended September 30, 2021 with respect to the recognition of revenue for the Novo Amendment, signed in November 2020. During the
fourth quarter of 2021, management reassessed the classification of the development activities associated with the DETECT-trial and concluded
that subsequent to the Novo Amendment the parties no longer shared joint control of these activities and, as such, these development
activities no longer met the definition of a joint operation, as defined in IFRS 11. Therefore, pursuant to the guidance in IFRS 15,
the Company reclassified the charges to Novo, from research and development expenses to development services revenue, in the related
periods. In addition, the license fees related to the pediatric indication were adjusted to reflect the revised pattern of recognition
as the performance obligation for the development services has now been combined with the pediatric license. In addition, the accounting
for prepaid expenses and other assets and deferred revenues related to the DETECT-trial expenses incurred were restated.
The
impacts of these restatements are as follows (amounts in thousands, except for basic and diluted loss per share):
| |
Previously
reported | | |
Effect
of restatement | | |
Amended | |
| |
$ | | |
$ | | |
$ | |
Consolidated interim statement of loss and
comprehensive loss for the three-month period ended March 31, 2021 | |
| | | |
| | | |
| | |
License fees | |
| 537 | | |
| (13 | ) | |
| 524 | |
Development service revenues | |
| — | | |
| 1,095 | | |
| 1,095 | |
Research and development expenses | |
| 363 | | |
| 1,095 | | |
| 1,458 | |
Net loss | |
| (1,445 | ) | |
| (13 | ) | |
| (1,458 | ) |
Total comprehensive
loss | |
| (16 | ) | |
| (13 | ) | |
| (29 | ) |
Basic and diluted loss
per share | |
| (0.02 | ) | |
| — | | |
| (0.02 | ) |
| |
| | | |
| | | |
| | |
Consolidated interim
statement of financial position as of March 31, 2021 | |
| | | |
| | | |
| | |
Prepaid expenses and other current assets | |
| 3,050 | | |
| 543 | | |
| 3,593 | |
Current portion of deferred revenues | |
| 2,101 | | |
| 556 | | |
| 2,657 | |
Deficit | |
| (323,222 | ) | |
| (13 | ) | |
| (323,235 | ) |
| |
Previously
reported | | |
Effect
of restatement | | |
Amended | |
| |
$ | | |
$ | | |
$ | |
Consolidated interim statement of loss and
comprehensive loss for the three-month period ended June 30, 2021 | |
| | | |
| | | |
| | |
License fees | |
| 537 | | |
| (45 | ) | |
| 492 | |
Development service revenues | |
| — | | |
| 1,030 | | |
| 1,030 | |
Research and development expenses | |
| 738 | | |
| 1,030 | | |
| 1,768 | |
Net loss | |
| (2,039 | ) | |
| (45 | ) | |
| (2,084 | ) |
Total comprehensive
loss | |
| (3,133 | ) | |
| (45 | ) | |
| (3,178 | ) |
Basic and diluted loss
per share | |
| (0.02 | ) | |
| — | | |
| (0.02 | ) |
| |
| | | |
| | | |
| | |
Consolidated interim
statement of loss and comprehensive loss for the six-month period ended June 30, 2021 | |
| | | |
| | | |
| | |
License fees | |
| 1,074 | | |
| (58 | ) | |
| 1,016 | |
Development service
revenues | |
| — | | |
| 2,125 | | |
| 2,125 | |
Research and development
expenses | |
| 1,101 | | |
| 2,125 | | |
| 3,226 | |
Net loss | |
| (3,484 | ) | |
| (58 | ) | |
| (3,542 | ) |
Total comprehensive
loss | |
| (3,149 | ) | |
| (58 | ) | |
| (3,207 | ) |
Basic and diluted loss
per share | |
| (0.03 | ) | |
| — | | |
| (0.03 | ) |
| |
| | | |
| | | |
| | |
Consolidated interim
statement of financial position as of June 30, 2021 | |
| | | |
| | | |
| | |
Prepaid expenses and other current assets | |
| 3,308 | | |
| 1,067 | | |
| 4,375 | |
Current portion of deferred revenues | |
| 2,125 | | |
| 1,111 | | |
| 3,236 | |
Deficit | |
| (326,229 | ) | |
| (58 | ) | |
| (326,287 | ) |
| |
Previously
reported | | |
Effect
of restatement | | |
Amended | |
| |
$ | | |
$ | | |
$ | |
Consolidated interim statement of loss and
comprehensive loss for the three-month period ended September 30, 2021 | |
| | | |
| | | |
| | |
License fees | |
| 527 | | |
| (234 | ) | |
| 293 | |
Development service revenues | |
| — | | |
| 684 | | |
| 684 | |
Research and development expenses | |
| 801 | | |
| 684 | | |
| 1,485 | |
Net loss | |
| (1,698 | ) | |
| (234 | ) | |
| (1,932 | ) |
Total comprehensive
loss | |
| (1,440 | ) | |
| (234 | ) | |
| (1,674 | ) |
Basic and diluted loss
per share | |
| (0.01 | ) | |
| (0.01 | ) | |
| (0.02 | ) |
| |
| | | |
| | | |
| | |
Consolidated interim
statement of loss and comprehensive loss for the nine-month period ended September 30, 2021 | |
| | | |
| | | |
| | |
License fees | |
| 1,601 | | |
| (292 | ) | |
| 1,309 | |
Development service
revenues | |
| — | | |
| 2,809 | | |
| 2,809 | |
Research and development
expenses | |
| 1,902 | | |
| 2,809 | | |
| 4,711 | |
Net loss | |
| (5,182 | ) | |
| (292 | ) | |
| (5,474 | ) |
Total comprehensive
loss | |
| (4,589 | ) | |
| (292 | ) | |
| (4,881 | ) |
Basic and diluted loss
per share | |
| (0.05 | ) | |
| — | | |
| (0.05 | ) |
| |
| | | |
| | | |
| | |
Consolidated interim
statement of financial position as of September 30, 2021 | |
| | | |
| | | |
| | |
Prepaid expenses and other current assets | |
| 3,431 | | |
| 600 | | |
| 4,031 | |
Current portion of deferred revenues | |
| 2,075 | | |
| 943 | | |
| 3,018 | |
Deficit | |
| (327,708 | ) | |
| (292 | ) | |
| (328,000 | ) |
These
restatements did not impact the Company’s cash and cash equivalent amounts and reported amounts of operating, investing and financing
activities within the consolidated interim statements of cash flows for the three-month period ended March 31, 2021 and the three-month
and six-month periods ended June 30, 2021 and three-month and nine-month periods ended September 30, 2021. Nor did these restatements
have any impact on 2020 results. No amended financial statements will be filed.
Operating
expenses
Our
total operating expenses for the three-month period ended December 31, 2021 were $4.1 million as compared with $3.6 million for the same
period in 2020, representing an increase of $0.5 million. This increase arose primarily from a $1.3 million increase in research and
development expenses, a $0.5 million increase in general and administrative expenses and $0.1 million in costs incurred in 2020 and not
incurred in 2021 (comprised of $0.1 million in reversal of impairment of other asset), offset by a decline of $1.4 million in cost of
sales, as discussed below.
Research
and development expenses
The
following table summarizes our research and development expenses incurred during the periods indicated (amounts in thousands, except
percentages):
| |
QUARTER
ENDED DECEMBER 31, | | |
| | |
| |
| |
2021 | | |
2020 | | |
$
CHANGE | | |
%
CHANGE | |
Macrilen™ (macimorelin) pediatric
trial direct research and development expenses (DETECT-trial) | |
$ | 526 | | |
$ | (32 | ) | |
$ | 558 | | |
| 1,743.8 | % |
AEZS-130 direct research and development expenses | |
| 143 | | |
| — | | |
| 143 | | |
| 100.0 | % |
DC-PTH direct research and development expenses | |
| 63 | | |
| — | | |
| 63 | | |
| 100.0 | % |
Parkinsons direct research and development
expenses | |
| 171 | | |
| — | | |
| 171 | | |
| 100.0 | % |
Covid-19 direct research and development expenses | |
| 137 | | |
| — | | |
| 137 | | |
| 100.0 | % |
NMOSD direct research and development expenses | |
| 106 | | |
| — | | |
| 106 | | |
| 100.0 | % |
Chlamydia direct research and development expenses | |
| 108 | | |
| — | | |
| 108 | | |
| 100.0 | % |
Additional programs’
direct research and development expenses | |
| 249 | | |
| 333 | | |
| (84 | ) | |
| (25.2 | )% |
Total direct research and
development expenses | |
| 1,503 | | |
| 301 | | |
| 1,202 | | |
| 399.3 | % |
Employee-related expenses | |
| 335 | | |
| 226 | | |
| 109 | | |
| 48.2 | % |
Facilities, depreciation,
and other expenses | |
| 25 | | |
| 99 | | |
| (74 | ) | |
| (74.7 | )% |
Total | |
$ | 1,863 | | |
$ | 626 | | |
$ | 1,237 | | |
| 197.6 | % |
Research
and development expenses increased $1.2 million for the quarter ended December 31, 2021 compared to the quarter ended December 31, 2020
primarily due to $1.2 million increase in direct research and development expenses. Direct research and development expenses include
expenses incurred under arrangements with third parties, such as a contract research organization for the DETECT-trial, contract manufacturers,
and consultants. The $1.2 million increase in total direct research and development expenses for the quarter ended December 31, 2021
was primarily due to a $0.6 million increase in costs for the DETECT-trial and a $0.6 million increase in the initiation of our new pre-clinical
projects with universities. During the fourth quarter of 2021, management reassessed the classification of the charges to Novo for development
activities associated with the DETECT-trial and reclassified them from direct research and development expenses to development services
revenue, as discussed in further detail above in “Revenues” in the Results from operations section of this MD&A. In 2020,
the Company accounted for employee charges to Novo for the DETECT-trial relating as a reduction in the direct research and development
costs, while the gross employee costs remained in the ‘Employee-related expenses’ in the analysis above. This classification
led to the negative direct expenses for the DETECT-trial
In
the fourth quarter of 2021, the Company was actively recruiting patients for the DETECT-trial. This is in contrast to 2020, when we were
primarily focused on the completion of our pediatric Study P01 for macimorelin which established the dose that is being used in the DETECT-trial.
In addition to the DETECT-trial, the Company was actively working with its university research partners on the named pre-clinical programs,
which primarily began in the first quarter of 2021. Of note, the Parkinsons’ project became active in the fourth quarter of 2021
after being in-licensed in the third quarter of 2021.
Employee-related
expenses have increased in 2021 by $0.1 million for the quarter ended December 31, 2021 as compared to the quarter ended December 31,
2020 primarily from the impact of the addition of Dr. Michael Teifel as our Chief Scientific Officer in May 2021 and of our Head of Quality
Control and CMC-Regulatory in March 2021, to better support our new pre-clinical initiatives.
Facilities,
depreciation, and other expenses have declined by $0.1 million for the quarter ended December 31, 2021 as compared to the quarter ended
December 31, 2020 primarily from the impact of lease negotiations for its German subsidiary initiated in 2020. Effective March 31, 2020,
the Company modified its existing building lease agreement with its landlord, significantly reducing its leased space and leasing costs,
and ultimately leading to the extension of its lease term to March 31, 2023.
General
and administrative expenses
General
and administrative expenses increased by $0.5 million for the quarter ended December 31, 2021 compared to the quarter ended December
31, 2020, due to increased directors and officers’ insurance coverage of $0.2 million, for recruiting costs pertaining to the Chief
Financial Officer role of $0.1 million, and increased salary and bonus costs of $0.1 million.
Cost
of sales
Cost
of sales decreased by $1.3 million in the fourth quarter of 2021 as compared with the same quarter in 2020, as there were no purchases
of macimorelin by any licensee in 2021 as compared to the sale of one batch of Macrilen™ in the fourth quarter of 2020 to Novo.
Net
Loss
For
the three-month period ended December 31, 2021, we reported a consolidated net loss of $2.9 million, or $0.02 loss per common share (basic
and diluted), as compared with a consolidated net loss of $1.3 million, or $0.02 loss per common share (basic and diluted) for the three-month
period ended December 31, 2020. The $1.6 million increase in net loss is primarily from a $0.5 million increase in total operating expenses
and a $1.4 million decrease in revenues, partially offset by a $0.4 million reduction in income tax expense, as discussed above.
Fiscal
Year-End
Revenues
Our
total revenue for the twelve-month period ended December 31, 2021 was $5.3 million as compared with $3.7 million for the same period
in 2020, representing an increase of $1.6 million, primarily due to $3.3 million increase in development services with Novo and $0.8 million increase in license fees related to the partial recognition of the €5 million up front payment
received from Novo in 2020 offset by a $2.4 million decline in product sales (as no product sales were generated in 2021).
Operating
expenses
Our
total operating expenses for the twelve-month period ended December 31, 2021 was $13.9 million as compared with $9.4 million for the
same period in 2020, representing an increase of $4.5 million. This increase arises primarily from a $5.1 million increase in research
and development expenses, $1.1 million increase in general and administration expenses, $0.3 million in increase in selling expenses
and $0.3 million in costs incurred in 2020 and not incurred in 2021 (comprised of $0.2 million in gain on modification of building lease
and $0.1 million in reversal of impairment of other asset), offset by a $2.2 million decrease in cost of sales, as discussed below.
Research
and development expenses
The
following table summarizes our research and development expenses incurred during the periods indicated (amounts in thousands, except
percentages):
| |
YEAR
ENDED DECEMBER 31, | | |
| | |
| |
| |
2021 | | |
2020 | | |
$
CHANGE | | |
%
CHANGE | |
Macrilen™ (macimorelin)
pediatric trial direct research and development expenses (DETECT-trial) | |
$ | 3,244 | | |
$ | 184 | | |
$ | 3,060 | | |
| 1,663.0 | % |
AEZS-130 direct research and development
expenses | |
| 230 | | |
| — | | |
| 230 | | |
| 100.0 | % |
DC-PTH direct research and development expenses | |
| 154 | | |
| — | | |
| 154 | | |
| 100.0 | % |
Parkinson’s direct research and development
expenses | |
| 171 | | |
| — | | |
| 171 | | |
| 100.0 | % |
Covid-19 direct research and development
expenses | |
| 712 | | |
| — | | |
| 712 | | |
| 100.0 | % |
NMOSD direct research and development expenses | |
| 453 | | |
| — | | |
| 453 | | |
| 100.0 | % |
Chlamydia direct research and development
expenses | |
| 146 | | |
| — | | |
| 146 | | |
| 100.0 | % |
Additional programs’
direct research and development expenses | |
| 486 | | |
| 475 | | |
| 11 | | |
| 2.3 | % |
Total direct research
and development expenses | |
| 5,596 | | |
| 659 | | |
| 4,937 | | |
| 749.2 | % |
Employee-related expenses | |
| 839 | | |
| 653 | | |
| 186 | | |
| 28.5 | % |
Facilities, depreciation,
and other expenses | |
| 139 | | |
| 194 | | |
| (55 | ) | |
| (28.4 | )% |
Total | |
$ | 6,574 | | |
$ | 1,506 | | |
$ | 5,068 | | |
| 336.5 | % |
Research
and development expenses increased $5.1 million for the year ended December 31, 2021 as compared to the year ended December 31, 2020
primarily due to $4.9 million increase in direct research and development expenses. Direct research and development expenses include
expenses incurred under arrangements with third parties, such as a contract research organization for the DETECT-trial, contract manufacturers,
and consultants. The $4.9 million increase in total direct research and development expenses for the year ended December 31, 2021 was
primarily due to a $3.1 million increase in costs for the DETECT-trial and a $1.8 million increase in the initiation of our new pre-clinical
projects with universities for named projects. In the second quarter of 2021, the DETECT-trial became active and we announced the opening
of the first clinical site in the U.S. During the fourth quarter of 2021, management reassessed the classification of the charges to
Novo for development activities associated with the DETECT-trial and reclassified them from direct research and development expenses
to development services revenue, as discussed in further detail above in “Revenues” in the 2021 compared with 2020 for the
Fourth Quarter from this section of this Annual Report.
Employee-related
expenses have increased in 2021 by $0.2 million as compared to the year ended December 31, 2020 primarily from the addition of two senior
members of our research and development team earlier in 2021.
Facilities,
depreciation, and other expenses have declined in 2021 by $0.1 million as compared to the year ended December 31, 2020, primarily from
the impact of lease negotiations for its German subsidiary which were completed early in 2020 and resulted in the negotiated reduction
in leased space for its German subsidiary.
General
and administrative expenses
General
and administrative expenses increased by $1.1 million for the year ended December 31, 2021 compared to the year ended December 31, 2020,
primarily from higher share based compensation of $0.2 million, higher spending on media and communication of $0.2 million, increased
directors and officers’ insurance coverage of $0.2 million, higher professional fees of $0.2 million, increased higher public company
costs of $0.2 million from holding our annual shareholders meeting in May 2021, subsequent to our issuance of common shares in the February
2021 Financing and the 2021 Warrant Exercises, in addition to recruiting costs for the Chief Financial Officer role of $0.1 million.
Cost
of sales
Cost
of sales decreased by $2.2 million during the year ended December 31, 2021 as compared to the same period in 2020, as there were no purchases
of macimorelin by any licensee in 2021 as compared to the sale of two batches of Macrilen™ to Novo in 2020.
Net
finance income
Our
net finance income for the twelve-month period ended December 31, 2021 was $0.2 million as compared with $1.0 million for the same period
in 2020, representing a decrease of $0.8 million. This is primarily due to a $1.1 million change in fair value of warrant liability,
a $0.4 million decline in gain due to change in foreign currency, offset by a $0.7 million decline in other finance costs. During the
prior year, the Company registered the common shares underlying certain warrants which allowed the Company to reclassify such warrants
from liability to shareholders’ equity in the consolidated statements of financial position. As such the change in fair value of
such warrants liabilities was classified as a finance cost in the consolidated statements of loss in 2020; there was no such change in
fair value in 2021.
Net
Loss
For
the twelve-month period ended December 31, 2021, we reported a consolidated net loss of $8.4 million, or $0.07 loss per common share
(basic and diluted), as compared with a consolidated net loss of $5.1 million, or $0.12 loss per common share (basic and diluted), for
the year ended December 31, 2020. The $3.3 million increase in net loss is primarily from a $4.5 million increase in operating expenses
and a $0.8 million decline in net finance income, partially offset by an increase of $1.6 million in total revenues and a change in income
tax recovery of $0.5 million, as previously discussed.
2020
compared with 2019
Fourth
Quarter
Revenues
Our
total revenue for the three-month period ended December 31, 2020 was $2.4 million as compared with $0.02 million for the same period
in 2019, representing an increase of $2.4 million. The 2020 revenue was comprised of $1.4 million in product sales (2019 - $nil), $0.9
million in licensing revenue (2019 - $0.02 million), $0.02 million in royalty revenue (2019 - $0.2 million) and $0.1 million in supply
chain revenue (2019 – ($0.02) million).
On
November 16, 2020, the Company announced that it had entered into the Amendment of its existing License Agreement and received an upfront
payment of €5 million ($6.1 million) in December 2020. Management determined that the remaining performance obligation
under the contract which provides the customer with a license of a future FDA approved pediatric indication is a distinct
performance obligation before and after the modification. Accordingly, the Company accounted for the modification to the License
Agreement as an adjustment to the existing License Agreement with Novo, on a prospective basis. The portion of the changes in the
transaction price that was attributable to the change in future royalty rate was allocated to both the adult and pediatric
indications. Based on the change in future royalty rates, the Company determined that $0.6 million of the additional
upfront payment should be allocated to the Adult Indication. Accordingly, the Company recognized $0.6 million related
to the adult indication in revenues for the year ended December 31, 2020 and has deferred $5.6 million to be recognized over time until
the expected FDA approval date of June 2023.
Operating
expenses
Our
total operating expense for the three-month period ended December 31, 2020 was $3.6 million as compared with $1.8 million for the same
period in 2019, representing an increase of $1.8 million. This increase arises primarily from a $1.1 million increase in cost of sales,
$0.4 million increase in research and development costs, $0.4 million increase in selling expenses and $0.5 million in costs incurred
in the fourth quarter of 2019 and not incurred in the fourth quarter of 2020 (comprised of $0.3 million in restructuring costs and approximately
$0.2 million in impairment of right of use asset), offset by a decline of $0.4 million in general and administrative expenses and a reversal
of $0.1 million of write off of other asset.
In
the fourth quarter of 2020, cost of sales increased from the sale of a batch of macimorelin to Novo Nordisk. The increase in research
and development costs reflect the Company’s initial pipeline expansion activities in 2020 as compared to close out activities for
Study P01 in 2019. The impact of our June 2019 restructuring in our German subsidiary, namely for payroll and share based compensation
costs, was a key influence in the declines in general and administrative expenses.
Net
finance costs
Our
net finance income for the three-month period ended December 31, 2020 was $0.3 million as compared with $0.6 million for the same period
in 2019, representing a decrease of $0.3 million. This is primarily due to a $0.5 million lower gain in the change in fair value of warrant
liability offset by $0.3 million from changes in currency exchange rates. By December 31, 2020, the Company had registered all of the
common shares underlying all of its issued and outstanding warrants.
Net
loss
For
the three-month period ended December 31, 2020, we reported a consolidated net loss of $1.3 million, or $0.02 loss per common share (basic),
as compared with a consolidated net loss of $1.0 million, or $0.05 loss per common share for the three-month period ended December 31,
2019. The $0.3 million increase in net results is primarily from an increase in total operating expenses of $1.8 million, an increase
in net finance costs of $0.2 million, a change of tax expenses of $0.6 million partially offset by an increase in revenues of $2.3 million
in operating expenses.
Fiscal
Year-End
Revenues
Our
total revenue for the twelve-month period ended December 31, 2020 was $3.7 million as compared with $0.5 million for the same period
in 2019, representing an increase of $3.2 million. The 2020 revenue was comprised of $2.4 million in product sales (2019 – $0.1
million), $0.9 million in licensing revenue (2019 - $0.07 million), $0.3 million in supply chain (2019 - $0.3 million) and $0.07 million
in royalty income (2019 - $0.05 million).
On
November 16, 2020, the Company announced that it had entered into the Amendment of its existing License Agreement and received an upfront
payment of €5 million ($6.1 million) in December 2020. Management determined that the remaining performance obligation
under the contract which provides the customer with a license of a future FDA approved pediatric indication is a distinct
performance obligation before and after the modification. Accordingly, the Company accounted for the modification to the License
Agreement as an adjustment to the existing License Agreement with Novo , on a prospective basis. The portion of the changes in the
transaction price that was attributable to the change in future royalty rate was allocated to both the adult and pediatric
indications. Based on the change in future royalty rates, the Company determined that $0.6 million of the additional
upfront payment should be allocated to the Adult Indication. Accordingly, the Company recognized $0.6 million related
to the adult indication in revenues for the year ended December 31, 2020 and has deferred $5.6 million to be recognized over time until
the expected FDA approval date of June 2023.
Operating
expenses
Our
total operating expense for the twelve-month period ended December 31, 2020 was $9.4 million as compared with $10.8 million for the same
period in 2019, representing a decrease of $1.4 million. This decline arises primarily from a $1.9 million reduction in general and administration
expenses, a decrease of $0.5 million in restructuring costs, a $0.3 million reduction in research and development costs, a $0.3 million
reversal in write off of other asset, a $0.2 million gain on modification of building lease and $0.1 million reduction in selling costs,
offset by an increase of $1.9 million in cost of sales. This decline in operating expenses is in-line with the expected impact of our
cost control initiatives as previously implemented and the impact of the 2019 restructuring at our German subsidiary.
Net
finance income
Our
net finance income for the year ended December 31, 2018 was $1.2 million, as compared to $2.8 million for the same period in 2017, representing
a decrease of $1.6 million. The decline in net finance income is primarily due to the change in fair value of our warrant liability.
Such change in fair value results from the periodic “mark-to-market” revaluation via the application of pricing models to
our outstanding share purchase warrants. The closing price of our Common Shares, which, on the NASDAQ, fluctuated from $1.19 to $3.87
during the twelve-month period ended December 31, 2018, compared to $2.67 to $2.70 during the same period in 2017, also had a direct
impact on the change in fair value of warrant liability.
Net
Loss
For
the twelve-month period ended December 31, 2020, we reported a consolidated net loss of $5.1 million, or $0.12 loss per common share,
as compared with a consolidated net loss of $6.0 million, or $0.35 loss per common share (basic), for the twelve-month period ended December
31, 2019. The $0.9 million improvement in net results is primarily from an increase in total revenues of $3.1 million and a reduction
of operating expenses of $1.4 million partially offset by a $3.0 million decline in net finance income and an increase in income tax
expense of $0.6 million.
Selected
quarterly financial data
| |
Three
months ended | |
(in thousands, except
for per share data) | |
December
31, 2021 | | |
September
30, 2021(1) | | |
June
30, 2021(1) | | |
March
31, 2021(1) | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Revenues | |
| 956 | | |
| 1,052 | | |
| 1,584 | | |
| 1,668 | |
Net loss | |
| (2,894 | ) | |
| (1,932 | ) | |
| (2,084 | ) | |
| (1,458 | ) |
Net loss per share (basic
and diluted)(2) | |
| (0.02 | ) | |
| (0.02 | ) | |
| (0.02 | ) | |
| (0.02 | ) |
| |
Three
months ended | |
(in
thousands, except for per share data) | |
December
31, 2020 | | |
September
30, 2020 | | |
June
31, 2020 | | |
March
31, 2020 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Revenues | |
| 2,366 | | |
| 128 | | |
| 68 | | |
| 1,090 | |
Net (loss) income | |
| (1,311 | ) | |
| (1,136 | ) | |
| (3,450 | ) | |
| 779 | |
Net (loss) income per share
(basic and diluted)(2) | |
| (0.02 | ) | |
| (0.02 | ) | |
| (0.15 | ) | |
| 0.04 | |
|
(1) |
The
restatements are discussed above under “Revenues” in the Results from operations section of this 20-F comparing 2021
with 2020 for the Fourth Quarter (which had no impact on 2020). The interim financial statements for the periods ended March
31, 2021, June 30, 2021 and September 30, 2021 have not been refiled but the comparatives will be corrected when the interim financial
statements for the periods ended March 31, 2022, June 30, 2022 and September 30, 2022 are filed. These restatements did not have
any impact on 2020 results. |
|
(2) |
Net
loss per share is based on the weighted average number of shares outstanding during each reporting period, which may differ on a
quarter-to-quarter basis. As such, the sum of the quarterly net loss per share amounts may not equal full-year net loss per share.
|
Historical
quarterly results of operations and net (loss) income cannot be taken as reflective of recurring revenue or expenditure patterns of predictable
trends, largely given the non-recurring nature of certain components of our historical revenues, due most notably to unpredictable quarterly
variations in net finance income, which are impacted by periodic “mark-to-market” revaluations of our warrant liability and
of foreign exchange gains and losses.
Condensed
Consolidated Statement of Financial Position Information
(in thousands) | |
As
of
December 31, 2021 | | |
As
of
December 31, 2020 | | |
As
of
December 31, 2019 | |
| |
$ | | |
$ | | |
$ | |
Cash and cash equivalents | |
| 65,300 | | |
| 24,271 | | |
| 7,838 | |
Trade and other receivables and other current
assets | |
| 5,447 | | |
| 3,322 | | |
| 1,869 | |
Inventory | |
| 73 | | |
| 21 | | |
| 1,203 | |
Restricted cash equivalents | |
| 335 | | |
| 338 | | |
| 364 | |
Property, plant and equipment | |
| 42 | | |
| 22 | | |
| 35 | |
Right of use assets | |
| 150 | | |
| 157 | | |
| 582 | |
Other non-current
assets | |
| 8,755 | | |
| 8,874 | | |
| 8,090 | |
Total
assets | |
| 80,102 | | |
| 37,005 | | |
| 19,981 | |
Payables and accrued liabilities and income
taxes payable | |
| 2,787 | | |
| 2,322 | | |
| 3,596 | |
Current portion of provisions | |
| 34 | | |
| 92 | | |
| 418 | |
Current portion of deferred revenues | |
| 4,815 | | |
| 2,193 | | |
| 991 | |
Lease liabilities | |
| 161 | | |
| 184 | | |
| 903 | |
Warrant liability | |
| — | | |
| — | | |
| 2,225 | |
Non-financial
non-current liabilities (*) | |
| 19,319 | | |
| 19,003 | | |
| 14,281 | |
Total
liabilities | |
| 27,116 | | |
| 23,794 | | |
| 22,444 | |
Shareholders’
equity (deficiency) | |
| 52,986 | | |
| 13,211 | | |
| (2,463 | ) |
Total
liabilities and shareholders’ equity (deficiency) | |
| 80,102 | | |
| 37,005 | | |
| 19,981 | |
(*)
Comprised mainly of employee future benefits, provisions, deferred gain and non-current portion of deferred revenues.
Outstanding
Share Data
As
at March 25, 2022, we had 121,397,007 common shares issued and outstanding, as well as 1,086,368 stock options, 423,000 deferred
share units and 11,441,213 warrants outstanding representing a total of 11,441,213 equivalent common shares.
Recent
Accounting Pronouncements
The
IASB continues to issue new and revised IFRS. A listing of the recent accounting pronouncements promulgated by the IASB and not yet adopted
by the Company is included in note 4 to the Company’s December 31, 2021 consolidated financial statements which are included in
Item 17 of this Annual Report on Form 20-F.
B. |
Liquidity,
Cash Flows and Capital Resources |
Since
inception, the Company has incurred significant expenses in its efforts to develop and co-promote products. Our current business focus
is to: investigate further therapeutic uses of Macrilen™, expand pipeline development activities, further expand the commercialization
of macimorelin in available territories and fund our 50% share of the DETECT-trial costs which exceed €9 million. Consequently,
the Company has incurred operating losses and has generated negative cash flow from operations historically and in each of the last several
years except for the year ended December 31, 2018 when the Company earned revenue from the sale of a license for the adult indication
of Macrilen™ (macimorelin) in the U.S. and Canada. The Company expects to incur significant expenses and operating losses for the
foreseeable future as it advances its product candidates through preclinical and clinical development, seeks regulatory approval and
pursues commercialization of any approved product candidates. We expect that our research and development costs will increase in connection
with our planned research and development activities.
As
of December 31, 2021, the Company had cash and cash equivalents of $65.3 million and an accumulated deficit of $334.6 million. The Company
also had a net loss of $8.4 million and negative cash flows from operations of $8.6 million for the year ended December 31, 2021. We
believe that our existing cash on hand will be sufficient to fund our anticipated operating and capital expenditure requirements through
2023. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we
expect. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
Registered
and Private Offerings
On
March 28, 2017, we commenced a new at-the-market (“ATM”) offering pursuant to the existing ATM Sales Agreement, dated April
1, 2016, under which we were able, at our discretion, from time to time, to sell up to a maximum of 3 million common shares through ATM
issuances on the NASDAQ, up to an aggregate amount of $9.0 million (the “March 2017 ATM Program”). The common shares
were to be sold at market prices prevailing at the time of the sale of the common shares and, as a result, sale prices varied.
Between
March 28, 2017 and April 18, 2017, we issued a total of 597,994 common shares under the March 2017 ATM Program at an average issuance
price of $2.97 per share for aggregate gross proceeds of $1.8 million less cash transaction costs of $55,000 and previously deferred
financing costs of $65,000.
On
April 27, 2017, we entered into a new ATM Sales Agreement (the “New ATM Sales Agreement”), and filed with the SEC
a prospectus supplement (the “Prospectus Supplement”) related to sales and distributions of up to a maximum of 2,240,000
common shares through ATM issuances on the NASDAQ, up to an aggregate amount of $6.9 million under the New ATM Sales Agreement. The common
shares will be sold at market prices prevailing at the time of the sale of the common shares and, as a result, prices may vary. The New
ATM Sales Agreement and the Prospectus Supplement superseded and replaced the March 2017 ATM Program, which itself had superseded and
replaced the April 2016 ATM Program. The Prospectus Supplement supplements the base prospectus included in our Shelf Registration Statement
on Form F-3, as amended (the “2017 Shelf Registration Statement”), which was declared effective by the SEC on April
27, 2017. Between May 30, 2017 and December 31, 2017, we issued 1.8 million common shares at an average issuance price of $2.08 per share
under the New ATM Sales Agreement.
On
September 20, 2019, we entered into a securities purchase agreement (the “2019 Securities Purchase Agreement”) with
institutional investors in the U.S. to purchase approximately $5.0 million of our Common Shares for $1.50 per share in a registered direct
offering and warrants to purchase Common Shares in a concurrent private placement. The gross proceeds from the offering were approximately
$5.0 million before deducting the placement agent’s fees and other estimated offering expenses. Under the terms of the 2019 Securities
Purchase Agreement, we sold 3,325,000 Common Shares. In a concurrent private placement, we issued unregistered warrants to purchase up
to approximately 3,325,000 Common Shares. The warrants are exercisable six months following the date of issuance and have an exercise
price of $1.65. The warrants will expire five years from the date of issuance. The Common Shares described above (but not the warrants
or the Common Shares underlying the warrants) were offered by us pursuant to a “shelf” registration statement on Form F-3,
as amended (the “2019 Shelf Registration Statement”), which was declared effective by the SEC on August 15, 2019.
On
February 21, 2020, the Company completed a registered direct offering for 3,478,261 common shares, at a purchase price of $1.29375 per
share, priced at-the-market. Additionally, the Company issued to the investors in the offering unregistered warrants to purchase up to
an aggregate of 2,608,696 common shares in a concurrent private placement. The warrants have an exercise price of $1.20 per common share,
are exercisable immediately and will expire five and one-half years following the date of issuance. The net cash proceeds to the Company
from the offering totaled $3.9 million. The Company issued 243,478 warrants to the placement agent with an exercise price of $1.61719
per common share, which are exercisable immediately and will expire five years following the date of issuance. Collectively, this financing
is referred to as the “February 2020 Financing”.
Effective
June 16, 2020, the Company registered under the Securities Act of 1933 the 2,608,696 investor warrants and 243,478 placement agent warrants
issued on February 21, 2020 and the 3,325,000 investor warrants issued on September 20, 2019.
On
July 7, 2020, the Company completed a public offering of 26,666,666 units at a price to the public of $0.45 per unit, for gross proceeds
of $12 million, before deducting placement agent fees and other offering expenses payable by the Company, in the amount of $1.4 million.
Each unit contained one common share (or common share equivalent in lieu thereof) and one investor share purchase warrant to purchase
one common share. In total, 26,666,666 common shares, 26,666,666 investor share purchase warrants with an exercise price of $0.45 per
share expiring July 7, 2025 and 1,866,667 placement agent warrants with an exercise price of $0.5625 per share expiring July 1, 2025
were issued. The net cash proceeds to the Company from the offering totaled $10.6 million. Collectively, this financing is referred to
as the “July 2020 Financing”.
On
August 5, 2020, the Company entered into a securities purchase agreement with several institutional investors in the U.S. providing for
the sale and issuance of 12,427,876 common shares at a purchase price of $0.56325 per common share in a registered direct offering priced
at-the-market under Nasdaq rules. The offering resulted in gross proceeds of $7 million. Concurrently, the Company issued to the purchasers
unregistered warrants to purchase up to an aggregate of 9,320,907 common shares. The warrants are exercisable for a period of five and
one-half years, exercisable immediately following the issuance date and have an exercise price of $0.47 per common share. In addition,
the Company issued unregistered warrants to the placement agent to purchase up to an aggregate of 869,952 common shares, with an exercise
price of $0.7040625 per share and an expiration date of August 3, 2025. The net cash proceeds to the Company from the offering totaled
$6.3 million. Effective September 14, 2020, the Company registered the common shares underlying the 9,320,907 investor warrants and 869,952
placement agent warrants issued on August 3, 2020 by way of a registration statement which removed the cashless exercise option for registered
warrants. Collectively, this financing is referred to as the “August 2020 Financing”.
During
the period between January 1, 2021 and December 31, 2021, holders have exercised certain of our outstanding warrants to purchase 35,111,187
of our common shares for gross proceeds of approximately $20.1 million (such exercises, the “Warrant Exercises”).
On
February 19, 2021, the Company closed a public offering of 20,509,746 common shares at a price to the public of $1.45 per common share,
for gross proceeds of $29.7 million, before deducting underwriting discounts, commissions and offering expenses payable by the Company,
in the amount of $2.8 million. Aeterna also granted the underwriter a 30-day overallotment option (the “Underwriter Option”)
to purchase up to 3,076,461 additional common shares at the public offering price, less underwriting discounts and commissions, and 1,435,682
warrants with an exercise price of $1.8125 and expiring on February 17, 2026. The net cash proceeds to the Company from the offering
totaled $26.9 million. On February 22, 2021, the underwriter exercised the Underwriter Option in full and received 3,076,461 common shares
for gross proceeds to the Company of $4.5 million. In connection with the public offering and the exercise of the Underwriter Option,
the Company paid commissions and other expenses of $0.4 million and issued 215,352 warrants priced at $1.8125 and expiring on February
17, 2026. Aggregate gross proceeds received in connection with the February 2021 Financing totaled $34.2 million, less cash transaction
costs of $3.2 million and non-cash transaction costs, which represent the issue-date fair value of the February 2021 Placement Agent
Warrants, of $1.9 million. Collectively, this financing is referred to as the “February 2021 Financing”.
The
variations in our liquidity by activity are explained below.
|
|
Three
months ended
December 31, |
|
|
Years
ended
December 31, |
|
(in
thousands) |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
2019 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Cash
and cash equivalents - Beginning of period |
|
|
68,002 |
|
|
|
21,746 |
|
|
|
24,271 |
|
|
|
7,838 |
|
|
|
14,512 |
|
Cash
flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash (used in) operating activities |
|
|
(2,413 |
) |
|
|
2,518 |
|
|
|
(8,581 |
) |
|
|
(4,129 |
)
|
|
|
(10,725 |
) |
|
|
|
(2,413 |
) |
|
|
2,518 |
|
|
|
(8,581 |
) |
|
|
(4,129 |
)
|
|
|
(10,725 |
) |
Cash
flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
proceeds from issuance of common shares and issuance of common shares and warrants |
|
|
—
|
|
|
|
— |
|
|
|
30,979 |
|
|
|
20,733 |
|
|
|
4,193 |
|
Proceeds
from exercise of warrants, stock options and deferred share units |
|
|
45 |
|
|
|
— |
|
|
|
20,087 |
|
|
|
— |
|
|
|
314 |
|
Proceeds
on deferred gain |
|
|
98 |
|
|
|
— |
|
|
|
98 |
|
|
|
— |
|
|
|
— |
|
Payments
on lease liability |
|
|
(32 |
) |
|
|
(17) |
|
|
|
(127 |
) |
|
|
(265 |
)
|
|
|
(614 |
)
|
|
|
|
111 |
|
|
|
(17) |
|
|
|
51,037 |
|
|
|
20,468 |
|
|
|
3,893 |
|
Cash
flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash (used in) provided by investing activities |
|
|
(124) |
|
|
|
— |
|
|
|
(658) |
|
|
|
56 |
|
|
|
50 |
|
|
|
|
(124) |
|
|
|
— |
|
|
|
(658) |
|
|
|
56 |
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect
of exchange rate changes on cash and cash equivalents |
|
|
(276) |
|
|
|
24 |
|
|
|
(769) |
|
|
|
38 |
|
|
|
108 |
|
Cash
and cash equivalents - End of period |
|
|
65,300 |
|
|
|
24,271 |
|
|
|
65,300 |
|
|
|
24,271 |
|
|
|
7,838 |
|
Operating
Activities
2021
compared to 2020
Cash
used by operating activities totaled $8.6 million for the twelve months ended December 31, 2021, as compared to $4.1 million used by
operating activities in the same period in 2020. This $4.5 million increase in spending in operating activities is attributed primarily
to $1.9 million spending on the pre-clinical development programs, four potential therapeutics and two potential vaccines initiated in
2021 in addition to $2.4 million decrease in product sales.
2020
compared to 2019
Cash
used by operating activities totaled $4.1 million for the twelve months ended December 31, 2020, as compared to $10.7 million used by
operating activities in the same period in 2019. This $6.6 million improvement in operating activities is attributed primarily to the
receipt of the non-refundable payment of $6.1 million (€5 million) from Novo Nordisk and the impact of the June 2019 restructuring
in Germany, primarily impacting payroll and share-based compensation costs.
Financing
Activities
2021
compared to 2020
Cash
provided by financing activities totaled $51.0 million for the twelve months ended December 31, 2021, as compared with cash provided
by financing activities of $20.5 million in the same period in 2020. In February 2021, the Company completed a financing which provided
$31.0 million in net funding (2020 – the Company completed three financings for $20.7 million in net funding). Throughout 2021,
holders exercised 35.1 million warrants resulting in proceeds to the Company of $20.1 million.
2020
compared to 2019
Cash
provided by financing activities totaled $20.5 million for the twelve months ended December 31, 2020, as compared with cash provided
by financing activities of $3.9 million in the same period in 2019. On February 21, 2020, the Company completed the February 2020 Financing
with net cash proceeds of $3.9 million. In 2020, the Company also completed the July 2020 Financing with net proceeds of $10.6 million
and the August 2020 Financing with net proceeds of $6.3 million (2019 – completed the September 2019 financing for $4.2 million).
Investing
Activities
2021
compared to 2020
Cash
used in investing activities totaled $0.7 million for the twelve months ended December 31, 2021, as compared with cash provided by investing
activities of $0.1 million in the same period in 2020. The $0.6 million year-over-year increase is attributable entirely to the five
pre-clinical development programs discussed above, for which we made payments to the University of Wuerzburg for $0.5 million and to
the University of Sheffield for $0.1 million.
2020
compared to 2019
Cash
flows from investing activities totaled $0.1 million for the year ended December 31, 2020, as compared with $0.1 million for the same
period in 2019 reflecting change being made in our restricted cash balances.
Critical
Accounting Policies, Estimates and Judgments
Our
consolidated financial statements as of December 31, 2021 and December 31, 2020 and for the years ended December 31, 2021, 2020
and 2019 have been prepared in accordance with IFRS as issued by the IASB.
The
preparation of consolidated financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions
that affect the reported amounts of our assets, liabilities, revenues, expenses and related disclosures. Judgments, estimates and assumptions
are based on historical experience, expectations, current trends and other factors that management believes to be relevant when our consolidated
financial statements are prepared.
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgments in order to ensure that the
consolidated financial statements are presented fairly and in accordance with IFRS. Revisions to accounting estimates are recognized
in the period in which the estimates are revised and in any future periods affected. Further details can be found in note 3 in the consolidated
financial statement as of December 31, 2021 and December 31, 2020 and for the years ended December 31, 2021, 2020 and 2019. Our most
significant accounting estimates and assumptions that the Company has made in the preparation of the consolidated financial statements
including accounting for a contract modification, license and collaboration arrangement with multiple elements, impairment of
goodwill, employee future benefits and research and development accrual.
Capital
Disclosures
The
Company’s objective in managing capital, consisting of shareholders’ equity (deficiency), with cash and cash equivalents
and restricted cash equivalents being its primary components, is to ensure sufficient liquidity to fund R&D costs, selling expenses,
G&A expenses and working capital requirements. Over the past several years, the Company has raised capital via public and private
equity offerings and issuances as its primary source of liquidity. The capital management objective of the Company remains the same as
that in previous periods. The policy on dividends is to retain cash to keep funds available to finance the activities required to advance
the Company’s product development portfolio and to pursue appropriate commercial opportunities as they may arise.
The
Company is not subject to any capital requirements imposed by any regulators or by any other external source.
Material
Cash Requirements
Contractual
obligations and commitments as of December 31, 2021
| |
Service and manufacturing | | |
R&D
contracts | | |
TOTAL | |
| |
$ | | |
$ | | |
$ | |
Less than 1 year | |
| 1,085 | | |
| 2,252 | | |
| 3,337 | |
1 – 3 years | |
| 6 | | |
| 1,049 | | |
| 1,055 | |
4 – 5 years | |
| - | | |
| - | | |
| - | |
More than 5 years | |
| - | | |
| - | | |
| - | |
Total | |
| 1,091 | | |
| 3,301 | | |
| 4,392 | |
During
2021, the Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements
may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company
generally has the right to terminate these agreements at no penalty.
Based
on the closing exchange rates at December 31, 2021, the Company expects to pay $3.3 million, including $3.1 million (€2.8 million),
and $0.2 million (£0.1 million), in R&D contracts and up to $8.9 million, including $7.4 million (€6.5 million) and $1.5
million (£1.2 million), in R&D milestone payments and up to $32.9 million, including $31.3 million (€27.6 million) and
$1.6 million (£1.3 million), in revenue related milestone payments. The table below contains all potential R&D and revenue-related
milestone payments that the Company may be required to make under such agreements:
(in thousands) | |
Future potential R&D milestone
payments | | |
Future
potential revenue milestone payments | | |
TOTAL | |
| |
| $ | | |
| $ | | |
| $ | |
Less than 1 year | |
| 28 | | |
| - | | |
| 28 | |
1 – 3 years | |
| 113 | | |
| - | | |
| 113 | |
4 – 5 years | |
| 927 | | |
| - | | |
| 927 | |
More than 5 years | |
| 7,869 | | |
| 32,942 | | |
| 40,811 | |
Total | |
| 8,937 | | |
| 32,942 | | |
| 41,879 | |
The
future payments that are disclosed represent contract payments and are not discounted and are not risk-adjusted. The development of any
pharmaceutical product candidates is a complex and risky process that may fail at any stage in the development process due to a number
of factors. The timing of the payments is based on the Company’s current best estimate of achievement of the relevant milestone.
C. |
Research
and development, patents and licenses, etc. |
For
a description of our R&D policies for the last three years, see “Item 4.B. Business Overview” and “Key Developments”
at the beginning of this Item 5. Over the past three years, our research and development activities have encompassed the 2018 initiation
of pediatric indication P01 study for MacrilenTM (macimorelin) for which Novo paid 70% of the costs, the 2021 initiation
of the PCT study for MacrilenTM (macimorelin) for which Novo is paying 100% of the initial €9 million of the trial
costs and 50% of any excess costs, in addition to our pipeline activities which consist of pre-clinical work.
Aeterna
is currently conducting its pivotal Phase 3 safety and efficacy study AEZS-130-P02 (the “DETECT-trial”) evaluating
macimorelin for the diagnosis of CGHD. Children and adolescents from two to less than 18 years of age with suspected growth hormone deficiency
are to be included. The study is expected to include approximately 100 subjects in Europe and North America, with at least 40 subjects
in pre-pubertal and 40 subjects in pubertal status. Macimorelin growth hormone stimulation test (“GHST”) will be performed
twice for repeatability data and two standard GHSTs will be used as controls: arginine (IV) and clonidine (orally). On April 22, 2021,
the U.S. FDA Investigational New Drug Application associated with this clinical trial became active. The first clinical sites in the
U.S. and in Europe are open for patient recruitment. In Europe, national clinical trial approval procedures and site initiation activities
are ongoing. At this point in time, we are closely monitoring delays in site activation and enrollment due to the ongoing COVID-19 pandemic,
to mitigate potential impact on estimated trial completion dates.
The
Company continues to advance its ongoing business development discussions to secure commercialization partners for macimorelin in additional
markets. In addition to its previously established agreements, Aeterna recently entered into a license agreement with NK Meditech Ltd.,
for the development and commercialization of macimorelin in the Republic of Korea, and a distribution agreement with Er-Kim Pharmaceuticals
Bulgaria EOOD for the commercialization of macimorelin in Turkey and some Balkan countries.
For
the development of AIM Biologicals as potential PD therapeutics, Aeterna plans to utilize, among others, an innovative animal model on
neurodegeneration by α-synuclein-specific T cells in AAV-A53T-α-synuclein Parkinson’s disease mice, which has recently
been published by University of Wuerzburg researchers.
Next
Steps – NMOSD
|
● |
Conduct
in-vitro and in-vivo assessments to select an AIM Biologicals-based development candidate. |
|
● |
Manufacturing
process development for selected candidate. |
Next
Steps – Parkinson’s Disease
|
● |
Design
and produce antigen-specific AIM Biologics molecules for the potential treatment of Parkinson’s disease. |
|
● |
Conduct
in-vitro and in-vivo assessments in relevant Parkinson’s disease models. |
In
consultation with the University of Sheffield, Aeterna has selected AEZS-150 as the lead candidate in its DC-PTH program. AEZS-150 is
being developed with the goal of providing a potential new treatment option of primary hypoparathyroidism in adults.
Next
Steps DC-PTH
|
● |
Work
with the University of Sheffield to conduct in depth characterization of development candidate (in-vitro and in-vivo). |
|
● |
Develop
manufacturing process. |
|
● |
Formalize
pre-clinical development of AEZS-150 in preparation for a potential IND filing for conducting the first in-human clinical study |
Apart
from already available pre-clinical and clinical data on macimorelin for the development as a diagnostic, Aeterna may utilize the established
supply chain to support this development. Alternative formulations are currently also under development, as a further option in addition
to the existing oral solution already approved for the diagnostic use in adult growth hormone deficiency (AGHD).
Next
Steps – Macimorelin as a Potential Therapeutic (ALS)
|
● |
Work
with the University of Queensland to conduct proof-of-concept studies with macimorelin in disease-specific animal models. |
|
● |
Assess
alternative formulations. |
|
● |
Formalize
pre-clinical development plan |
During
2021, the Company entered into a Research Agreement with the University of Wuerzburg on a fee-for-service basis to conduct supplementary
research activities and pre-clinical development studies on the potential vaccines, the results of which are covered within the scope
of the license agreements. Additionally, Prof. Dr. Thomas Rudel of the University of Wuerzburg was engaged by the Company in September
2021 as a scientific consultant to support development of the salmonella-based vaccine platform for the coronavirus and Chlamydia
vaccines.
Next
Steps – Coronavirus Vaccine
|
● |
Evaluate
administration route, dose and immunization scheme. |
|
● |
In-vivo
immunology experiments with antigen variant candidates in relevant mice models. |
|
● |
Conduct
virus challenge experiments in immunized transgenic animals. |
|
● |
Start
manufacturing process assessment / development. |
|
● |
Conduct
pre-clinical safety and toxicology assessment. |
Next
Steps – Chlamydia Vaccine
|
● |
Design
and prepare candidate vaccine strains. |
|
● |
Evaluate
administration route, dose and immunization scheme. |
|
● |
In-vivo
immunology experiments with candidate strains in relevant mouse models. |
Financial
Risk Factors and Other Instruments
The
nature and extent of our exposure to risks arising from financial instruments, including credit risk, liquidity risk and market risk
(share price risk) and how we manage those risks are described in note 24 to the Company’s
annual audited consolidated financial statements as of December 31, 2021 and 2020 and for the years ended December 31, 2021, 2020
and 2019.
The
consolidated financial statements filed as part of this Annual Report on Form 20-F are presented under “Item 17. –
Financial Statements”.
E. |
Critical Accounting Estimates |
See
Item 5.B above “Liquidity, Cash Flows and Capital Resources – Critical Accounting Policies, Estimates and Judgments”.
Item
6. Directors, Senior Management and Employees
A. |
Directors
and senior management |
The
following table sets forth information about our directors and our senior corporate officers as at December 31, 2021:
Name
and Place of Residence |
|
Position
with Aeterna Zentaris |
|
|
|
Ammer,
Nicola
Hessen,
Germany |
|
Senior
Vice President Clinical Development, Chief Medical Officer |
Auld,
Leslie
Ontario,
Canada |
|
Senior
Vice President, Chief Financial Officer |
Edwards,
Peter G.
Ohio,
United States |
|
Director |
Egbert,
Carolyn
Texas,
United States |
|
Director,
Chair of the Board |
Gagnon,
Gilles
Quebec,
Canada |
|
Director |
Gerlach,
Matthias
Hessen,
Germany |
|
Senior
Vice President Manufacturing and Supply Chain |
Grau,
Guenther
Hessen,
Germany |
|
Vice
President Finance |
Guenther,
Eckhard
Hessen,
Germany |
|
Senior
Vice President Business Development & Alliance Management; Managing Director AEZS Germany |
Paulini,
Klaus
Hessen,
Germany |
|
President,
Chief Executive Officer, Director; Managing Director AEZS Germany |
Turpin,
Dennis(1)
Quebec,
Canada |
|
Director |
Teifel,
Michael
Hessen,
Germany |
|
Senior
Vice President Non-Clinical Development, Chief Scientific Officer |
(1) |
Mr.
Turpin joined the Board on May 5, 2021. |
The
following is a brief biography of each of our directors and executive officers.
Nicola
Ammer was appointed as our Senior Vice President, Clinical Development and as Chief Medical Officer in January 2021. She serves as
one of our executive officers. Dr. Ammer, who is based in the Frankfurt, Germany office of AEZS Germany, began her career in the pharmaceutical
medicine environment in the CRO business in 2002 and gained experience in all aspects of clinical research & development in various
positions with increasing responsibility, including a Director of Clinical Operations. She joined AEZS Germany in March 2015 as Clinical
Program Director and took over the role of the Head of Clinical Development in January 2016. She possesses numerous skills in the area
of pharmaceutical medicine and contributed significantly to the successful completion of the macimorelin clinical development program
in the adult indication. Dr. Ammer obtained the license to practice medicine in 1995 after completion of her academic studies at the
University of Essen. She was awarded a doctorate diploma in medicine by the University of Münster in 2004 and a Master of Science
in Pharmaceutical Medicine by the University Duisburg-Essen in 2009.
Leslie
Auld was appointed as our Senior Vice President, Chief Financial Officer in September 2018. She has over twenty-five years of accounting,
finance and pharmaceutical industry experience, with increasingly senior roles at Helix BioPharma Corp., Luminex Diagnostics (formerly
TM BioScience Corp.), Attwell Capital Inc. (formerly Fralex Therapeutics) and GeneNews Limited. Ms. Auld was most recently the Chief
Financial Officer and Treasurer of GeneNews Limited from 2010 to 2018. A Chartered Professional Accountant, Ms. Auld graduated with an
Honors Bachelor of Science degree in Pharmacology & Toxicology from the Western University and has a Master of Business Administration
degree from the University of Toronto and began her career at PricewaterhouseCoopers.
Peter
G. Edwards joined the Board on May 15, 2020 and is a member of the Audit Committee and of the Nominating, Governance and Compensation
Committee. Mr. Edwards is currently General Counsel of Aziyo Biologics. Mr. Edwards served as the Executive Vice President and General
Counsel of Celanese Corporation from January 2017 to January 2019. Mr. Edwards previously was Executive Vice President and General Counsel
of Baxalta Incorporated, the biopharmaceutical spin-off from Baxter, from June 2015 until its merger with Shire plc in July 2016. Before
that, he was Senior Vice President and General Counsel of the global specialty pharmaceuticals company Mallinckrodt plc from July 2013
to June 2015 and served as its Vice President and General Counsel from May 2010 to its spin-off from Covidien plc in June of 2013. He
previously served as Executive Vice President and General Counsel for Solvay Pharmaceuticals in Brussels, Belgium from June 2007 until
April 2010 and as its Senior Vice President and General Counsel in the US from October 2005 to June 2007. Prior to that, he held in-house
positions of increasing responsibility within Mettler-Toledo, Inc. and Eli Lilly and Company. Mr. Edwards began his career in 1990 as
an associate in the Kansas City, Missouri office of Shook, Hardy & Bacon L.L.P. Mr. Edwards received his J.D., cum laude, from Brigham
Young University.
Carolyn
Egbert has served as a director on our Board since August 2012 and as Chair of our Board since May 2016. She is also a member of
the Nominating, Governance and Compensation Committee. After enjoying the private practice of law as a defense litigator in Michigan
and Washington, D.C., she joined Solvay America, Inc. (“Solvay”) (a chemical and pharmaceutical company) in Houston,
Texas. Over the course of a twenty-year career with Solvay, she held the positions of Vice President, Human Resources, President of Solvay
Management Services, Global Head of Human Resources and Senior Executive Vice President of Global Ethics and Compliance. During her tenure
with Solvay, she served as a director on the board of directors of seven subsidiary companies and as Chair of one subsidiary board. After
retiring in 2010, she established Creative Solutions for Executives, a consulting business providing expertise in corporate governance,
ethics and compliance, organizational development, executive compensation and strategic human resources. She holds a Bachelor of Sciences
degree in Biological Sciences from George Washington University, Washington D.C. and a Juris Doctor degree from Seattle University, Seattle,
Washington. She also was a Ph.D. candidate in Pharmacology at both Georgetown University Medical School at Washington, D.C. and Northwestern
University Medical School at Chicago, Illinois. She remains an active member of both the Michigan State Bar and the District of Columbia
Bar, Washington, D.C.
Gilles
Gagnon joined the Board on January 1, 2020 and is a member of the Audit Committee and of the Nominating, Governance and Compensation
Committee. Mr. Gagnon is currently the President and Chief Executive Officer of Ceapro Inc., a biotechnology company. Prior to that,
he was President and CEO of Aeterna Zentaris Inc. During the past 35 years, Mr. Gagnon has worked at several management levels within
the field of health, especially in the hospital environment and pharmaceutical industry. Mr. Gagnon has participated in several international
committees and strategic advisory boards. He served nine years on the board of directors of Canada’s Research Based Pharmaceutical
Companies (Rx&D—now Innovative Medicine Canada) where he represented members from the biopharmaceutical sector and pioneered
the Rx&D’s Canadian Bio partnering initiative. He is currently a member of the CEO Council of Innovative Medicine Canada. He
is a certified corporate Director having completed the Directors Education Program at the Rotman School of Management at the University
of Toronto, and he has served on several boards of both private and publicly listed companies in the biopharmaceutical sector.
Matthias
Gerlach was appointed as our Vice President, Manufacturing Operations in June 2014 and as Vice President, Manufacturing and Supply
Chain in January 2018. He serves as one of our executive officers. From December 2011 through May 2014, he was our Vice President, Medicinal
Chemistry. Dr. Gerlach, who is based in the Frankfurt office of AEZS Germany, began his career in the pharmaceutical industry in 1997.
He joined our Company in January 2001, assuming roles of increasing responsibility in areas of medicinal chemistry and preclinical development
through product commercialization during his career. He possesses numerous scientific and business skills and has a long record of successful
innovation, drug development and management, and contributed significantly to the successful U.S.-commercialization of macimorelin in
the adult indication. Dr. Gerlach obtained a diploma in Chemistry from the Johann Wolfgang Goethe University in Frankfurt in 1994 and
was awarded his doctorate diploma in synthetic organic chemistry by the Johann Wolfgang Goethe University in 1997.
Guenther
Grau was appointed as our Vice President, Finance in February 2018. Mr. Grau has been part of the Company since 2000. He began his
career in the pharmaceutical industry at ASTA Medica AG, a predecessor of our Company, in 1995, assuming roles of increasing responsibility
in areas of internal and external accounting during his career. Mr. Grau obtained a diploma in Business Administration from the Philipps-University,
Marburg, in 1991.
Eckhard
Guenther was appointed as Managing Director of Aeterna Zentaris GmbH in January 2020 and Senior Vice President of Business Development
& Alliance Management in 2021. Dr. Guenther brings more than 25 years in the pharmaceutical industry, with profound knowledge and
expertise in drug discovery and development in various indication areas like oncology and endocrinology. Additionally, over the course
of his career, he has gained extensive experience across research coordination, project management, intellectual properties and business
development. After receiving his Ph.D. in organic chemistry from the Martin-Luther University of Halle-Wittenberg (Germany), he started
his industrial career at Fahlberg-List Magdeburg in 1985. In 1990 he joined ASTA Medica AG in Frankfurt where he worked in the department
of Medicinal Chemistry. During his time at ASTA Medica, Dr. Guenther was significantly involved in the preparation and execution for
the spin-off of the biotechnology company Zentaris from ASTA Medica. After the founding of Aeterna Zentaris in 2002 he was appointed
to Vice President of Drug Discovery and Preclinical Research. In 2008 he was promoted to Vice President Alliance Management & Intellectual
Property and in 2014 he became Vice President of Business Development at Aeterna Zentaris. Dr. Guenther was responsible for the initiation
and execution of several research and development and licensing deals with midsize and large international pharmaceutical companies,
like Consilient Health, MegaPharm Ltd., Schering Pharma, Solvay, Yakult Honsha, Hikma Pharmaceuticals and Sinopharm A-Think. Dr. Guenther
is based in Frankfurt, Germany.
Dr.
Klaus Paulini was appointed President and Chief Executive Officer of the Company in October 2019 and also serves as a director on
our Board. Dr. Paulini is based in Frankfurt, Germany at our subsidiary AEZS Germany, where he was appointed Managing Director in July
2019 and as Vice President Quality and Regulatory in February 2018. Dr. Paulini began his career in the pharmaceutical industry at ASTA
Medica AG in 1997. He had an active role when Zentaris was formed and spun out of ASTA Medica and served in various roles with increasing
responsibility at the company ever since, including project responsibility for Cetrotide®. As Head of Quality Assurance from 2010
and 2019, Dr. Paulini successfully managed many of our clinical development projects – including Macrilen™/Macimorelin –
in the research and development phase as group leader medicinal chemistry. With his extensive experience and knowledge, he provided successful
oversight and valuable input for our pharmaceutical and clinical development programs, ensuring successful and compliant outcomes, ultimately
leading to regulatory approvals by the U.S. FDA and the EMA. Dr. Paulini obtained his PhD (Dr. Ing.) in chemistry at the Technical University
Darmstadt (Germany) in 1993 and specialized in medicinal chemistry/drug discovery during subsequent postdoctoral fellowships at Strathclyde
University (Glasgow, Scotland) and J.W. Goethe University (Frankfurt, Germany) before joining ASTA Medica AG.
Dennis
Turpin is a seasoned professional executive and chartered accountant (CA, CPA) with significant experience in finance and capital
markets transactions, business development and mergers and acquisitions, over 20 years of which has been in the biopharmaceutical industry.
He is currently the President and Chief Executive Officer of Endoceutics, Inc., a speciality biopharmaceutical company where he was previously
the Vice President, Special Projects. Mr. Turpin was previously the Vice President and Chief Financial Officer of the Quebec Port Authority
from February 2016 to June 2018. From 2007 to 2015,
Mr. Turpin was the Senior Vice President and Chief Financial Officer of Aeterna Zentaris and, between 2007 and 1996 he held various finance
roles with Aeterna Zentaris. Prior to that, he was a Director in the tax department at Coopers Lybrand, now PricewaterhouseCoopers, from
1988 to 1996 and worked as an auditor from 1985 to 1988. Mr. Turpin earned his Bachelor’s degree in Accounting from Laval University
in Québec. He obtained his license in accounting in 1985 and became a chartered accountant in 1987.
Michael
Teifel is a leading industry executive
with a career spanning over 20 years in various therapeutic areas, including endocrinology and oncology. He has deep experience in translating
research into clinical development. Over the course of his career, he has gained particular expertise in the design and implementation
of non-clinical development programs for small molecule drugs, peptides, targeted therapies, and biologics, as well as in the continued
non-clinical evaluation of drug candidates for global registration. Dr Teifel joined Aeterna Zentaris having held various positions in
industry with increasing responsibilities in pharmacology, pharmacokinetics, toxicology and translational sciences. He began his career
in industry at Roche Diagnostics in the area of delivery systems / non-viral gene therapy. In 1999, Dr. Teifel joined the biotech start-up,
Munich Biotech in Martinsried, Germany as a co-founder. As head of pharmacology & toxicology, he was responsible for the evaluation
and non-clinical development of a novel vascular targeting technology for the development of anti-tumor diagnostics and therapeutics.
In 2004, Dr. Teifel started his first term at Aeterna Zentaris where he held several positions in the field of preclinical development
and translational research. In his capacity he was, among others, responsible for preparation of the non-clinical dossier for registration
of macimorelin in the U.S. and EU in the indication AGHD. In 2019, Dr. Teifel left Aeterna Zentaris to pursue his career in non-clinical
research and development at Cleara Biotech in Utrecht, The Netherlands. As head of translational sciences at Cleara Biotech, he was responsible
for translating research on anti-senescent drugs into pre-clinical development in age-related diseases and late-stage cancer. In May
2021 he re-joined Aeterna Zentaris as Senior Vice-President Non-Clinical Development and Chief Scientific officer. Dr. Teifel holds a
degree in biology and his Ph.D. from the Technical University of Darmstadt, Germany.
There
are no family relationships between any of the persons named above and no arrangement with any customers, major shareholders, suppliers
or others pursuant to which any person above was selected as a director or executive officer. Each director holds office until the Company’s
next annual general meeting or until a successor is duly elected or appointed.
Our
directors and executive officers are generally paid in their home country currency. Unless otherwise indicated, all compensation information
included in this document is presented in U.S. dollars and, to the extent a director or officer has been paid in a currency other than
U.S. dollars, the amounts have been converted from such person’s home country currency to U.S. dollars based on the following annual
average exchange rates: for the financial year ended December 31, 2021: €1.000 = U.S.$1.182 and CAN$1.000 = U.S.$0.797; for the
financial year ended December 31, 2020: €1.000 = U.S.$1.140 and CAN$1.000 = U.S.$0.745; for the financial year ended December 31,
2019: €1.000 = U.S.$1.120 and CAN$1.000 = U.S.$0.754.
Compensation
of Outside Directors
The
compensation paid to members of our Board who are not our employees (our “Outside Directors”) is designed to (i) attract
and retain the most qualified people to serve on the Board and its committees, (ii) align the interests of the Outside Directors with
those of our shareholders, and (iii) provide appropriate compensation for the risks and responsibilities related to being an effective
Outside Director. This compensation is recommended to the Board by the Nominating, Governance and Compensation Committee (“NGCC”).
The NGCC is currently composed of three Outside Directors, each of whom is independent, namely Ms. Carolyn Egbert (Chair), Mr. Peter
G. Edwards and Mr. Gilles Gagnon.
The
Board has adopted a formal mandate for the NGCC, which is available on our website at www.zentaris.com. The mandate of
the NGCC provides that it is responsible for, among other matters, assisting the Board in developing our approach to corporate governance
issues, proposing new Board nominees, overseeing the assessment of the effectiveness of the Board and its committees, their respective
chairs and individual directors, making recommendations to the Board with respect to directors’ compensation and generally serving
in a leadership role for our corporate governance practices.
Retainers
Our
Outside Directors are paid an annual retainer, the amount of which depends on the position held on the Board. Annual retainers are paid
on a quarterly basis to our Outside Directors. Each Outside Director is paid the equivalent value of the payment in his or her home currency,
net of any withholdings or deductions required by applicable law.
Type
of Compensation | |
Annual
Retainer for the year 2021 | |
Chair of the Board Retainer | |
| 60,000 | |
Board Member Retainer | |
| 30,000 | |
Audit Committee Chair Retainer | |
| 20,000 | |
Audit Committee Member Retainer | |
| 5,000 | |
NGCC Chair Retainer | |
| 10,000 | |
NGCC Member Retainer | |
| 3,000 | |
All
Directors are reimbursed for travel and other out-of-pocket expenses incurred in attending Board or committee meetings. Retainers are
prorated when an Outside Director joins the Board during a financial year.
Outstanding
Awards
The
following table shows all awards outstanding to each Outside Director as at December 31, 2021:
| |
Option-based
Awards | | |
Share-based
Awards | |
Name | |
Issuance
Date (mm-dd-yyyy) | | |
Number
of Securities Underlying Unexercised Options (#) | | |
Option
Exercise Price ($) | | |
Option
Expiration Date (mm-dd-yyyy) | | |
Value
of Unexercised In-the-money
Options(1) ($) | | |
Issuance
Date (mm-dd-yyyy) | | |
Number
of Shares or Units of Shares that have Not Vested (#) | | |
Market
or Payout Value of Share-based Awards that have Not Vested(2) ($) | | |
Market
or payout value of vested share-based awards not paid out or distributed ($) | |
Edwards,
Peter | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 05/15/2020 | | |
| 30,000 | | |
| — | | |
| 10,800 | |
| |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 05/05/2021 | | |
| 70,000 | | |
| — | | |
| 25,200 | |
| |
| 05-10-2016 | | |
| 10,000 | | |
| 3.48 | | |
| 05-09-2023 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
| |
| 12-06-2016 | | |
| 7,850 | | |
| 3.45 | | |
| 12-06-2023 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
| |
| 08-15-2017 | | |
| 60,000 | | |
| 2.05 | | |
| 08-15-2024 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Egbert,
Carolyn | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 05/08/2018 | | |
| 23,000 | | |
| — | | |
| 8,280 | |
| |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 05/22/2019 | | |
| 30,000 | | |
| — | | |
| 10,800 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| 05/15/2020 | | |
| 30,000 | | |
| — | | |
| 10,800 | |
| |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 05/15/2021 | | |
| 70,000 | | |
| — | | |
| 25,200 | |
Gagnon,
Gilles | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 05/15/2020 | | |
| 30,000 | | |
| — | | |
| 10,800 | |
| |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 05/19/2021 | | |
| 70,000 | | |
| — | | |
| 25,200 | |
Turpin,
Dennis(3) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 05/19/2021 | | |
| 70,000 | | |
| — | | |
| 25,200 | |
(1)
“Value of unexercised in-the-money options” at financial year-end is calculated based on the difference between the closing
prices of the Common Shares on the NASDAQ on the last trading day of the fiscal year (December 31, 2021) of $0.36 and the exercise price
of the options, multiplied by the number of unexercised options.
(2)
The Company used the closing price of its Common Shares on the NASDAQ as at the last trading day of the fiscal year (December 31, 2021)
of $0.36.
(3)
Mr. Dennis Turpin joined the Board on May 5, 2021.
See
“Summary of the Stock Option Plan” for more details on the Company’s second amended and restated stock option plan
adopted by the Board on March 29, 2016 and ratified by the shareholders on May 10, 2016 (“Stock Option Plan”) and
see “Summary of Long-Term Incentive Plan” for more details on the Company’s long-term incentive plan adopted by the
Board on March 27, 2018, and ratified by the shareholders on May 8, 2018 (“Long-Term Incentive Plan”).
Total
Compensation of Outside Directors
The
table below summarizes the total compensation paid to our Outside Directors during the financial year ended December 31, 2021 (all amounts
are in U.S. dollars). Our Outside Directors are generally paid in their home currency. Mr. Desbiens, Mr. Gagnon and Mr. Turpin were paid
in Canadian dollars. Ms. Egbert and Mr. Edwards were paid in U.S. dollars.
Name | |
Fees
earned(1) ($) | | |
Share-based Awards(2) ($) | | |
Option-based
Awards ($) | | |
Non-Equity
Incentive Plan Compensation ($) | | |
Pension
Value ($) | | |
All
Other Compensation ($) | | |
Total ($)
| |
Desbiens, Pierre-Yves(3) | |
| 25,000 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 25,000 | |
Edwards, Peter | |
| 38,000 | | |
| 60,753 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 98,753 | |
Egbert, Carolyn | |
| 70,000 | | |
| 60,753 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 130,753 | |
Gagnon, Gilles | |
| 38,000 | | |
| 60,753 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 98,753 | |
Turpin, Dennis(4) | |
| 32,778 | | |
| 60,753 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 93,531 | |
(1)
In respect of our financial year ended December 31, 2021, we paid an aggregate amount of $203,778 to all of our Outside Directors for
services rendered in their capacity as directors, excluding reimbursement of out-of-pocket expenses and the value of share-based and
option-based awards granted in 2021.
(2)
Amounts shown represent the value of the DSUs on the grant date ($0.89). The value of one DSU on the grant date is the closing price
of one Common Share on the NASDAQ on the last trading day preceding the date of grant.
(3)
Mr. Pierre-Yves Desbiens served on the Board until May 5, 2021.
(4)
Mr. Dennis Turpin joined the Board on May 5, 2021.
Compensation
of Executive Officers
The
following is disclosure of information related to the compensation that we paid to our “Named Executive Officers” during
2021. For the 2021 year, our “Named Executive Officers” were as follows:
● |
Dr.
Klaus Paulini, who, since October 4, 2019, is serving as President and Chief Executive Officer, as well as Managing Director AEZS
Germany since July 2019; |
|
|
● |
Ms.
Leslie Auld, who, since September 24, 2018, is serving as Senior Vice President, Chief Financial Officer as an independent contractor;
and |
|
|
● |
Dr.
Matthias Gerlach, who serves as Vice President Manufacturing and Supply Chain; Mr. Eckhard Guenther, who serves as Vice President
Business Development & Alliance Management and Managing Director AEZS Germany; and Ms. Nicola Ammer, who serves as Chief Medical
Officer and Senior Vice President Clinical Development, who were our three most highly compensated executive officers (other than
our current and former Chief Executive Officer and our Chief Financial Officer) employed at the end of 2021. |
Compensation
Discussion & Analysis
Compensation
Philosophy and Objectives
Our
Board, through the NGCC, establishes our executive compensation program that is market-based and at a competitive percentile grouping
for both total cash and total direct compensation. The NGCC has established a compensation program that is designed to attract, motivate
and retain high-performing senior executives, encourage and reward superior performance and align the executives’ interests with
those of our shareholders by:
|
● |
providing the opportunity
for an executive to earn compensation that is competitive with the compensation received by executives serving in the same or measurably
similar positions within comparable companies; |
|
|
|
|
● |
providing the opportunity
for executives to participate in equity-based incentive compensation plans; |
|
|
|
|
● |
aligning executive compensation
with our corporate objectives; and |
|
|
|
|
● |
attracting and retaining
highly qualified individuals in key positions. |
Compensation
Elements
Our
executive compensation is targeted at the 50th percentile for small cap biopharmaceutical companies within both the local and national
markets and is comprised of both fixed and variable components. The variable components include equity and non-equity incentive plans.
Each compensation component is intended to serve a different function, but all elements are intended to work in concert to maximize both
corporate and individual performance by establishing specific, competitive operational and corporate goals and by providing financial
incentives to employees based on their level of attainment of these goals.
Our
current executive compensation program is comprised of the following four basic components: (i) base salary; (ii) an annual bonus linked
to both individual and corporate performance; (iii) equity incentives, including stock options, previously granted under our second amended
and restated stock option plan adopted by the Board on March 29, 2016 and ratified by the shareholders of Aeterna Zentaris on May 10,
2016 (the “Stock Option Plan”), and presently granted under the Corporation’s long-term incentive plan adopted
by the Board on March 27, 2018 and ratified by the shareholders of Aeterna Zentaris on May 8, 2018 (the “Long-Term Incentive
Plan”), established for the benefit of our directors, certain executive officers and other participants as may be designated
from time to time by either the Board or the NGCC; and (iv) other elements of compensation, consisting of benefits, perquisites and retirement
benefits.
Base
Salary. Base salaries are intended to provide a steady income to our executive officers regardless of share price. In determining
individual base salaries, the NGCC takes into consideration individual circumstances that may include the scope of an executive’s
position, the executive’s relevant competencies or experience and retention risk. The NGCC also takes into consideration the fulfillment
of our corporate objectives, as well as the individual performance of the executive.
Short-Term,
Non-Equity Incentive Compensation. Our short-term, non-equity incentive compensation plan sets a target cash bonus for each executive
officer, expressed as a percentage of the executive officer’s base salary. The amount of cash bonus paid to an executive officer
depends on the extent to which he or she contributed to the achievement of the annual performance objectives established by the Board
for the year. The annual performance objectives are specific operational, clinical, regulatory, financial, commercial and corporate goals
that are intended to advance our product pipeline, to promote the success of our commercial efforts and to enhance our financial position.
The annual performance objectives are set at the end of each financial year as part of the annual review of corporate strategies. The
performance objectives are not established for individual executive officers but rather by functional area(s), many of which are carried
out by or fall within the responsibility of our President and Chief Executive Officer, Chief Financial Officer (or principal financial
officer) and our other executive officers, including our Named Executive Officers. The award of a cash bonus requires the approval of
both the NGCC and the Board and is based upon an assessment of each individual’s performance, as well as our overall performance
at a corporate level. The determination of individual performance does not involve quantitative measures using a mathematical calculation
in which each individual performance objective is given a numerical weight. Instead, the NGCC’s determination of individual performance
is a subjective determination as to whether a particular executive officer substantially achieved the stated objectives or over-performed
or under-performed with respect to corporate objectives that were deemed to be important to our success.
Long-Term
Equity Compensation Plan of Executive Officers. The long-term component of the compensation of our executive officers is based exclusively
on the Long-Term Incentive Plan, which permits the issuance of a number of equity-based awards based on the contribution of the officers
and their responsibilities. The Board adopted a policy regarding stock option grants in December 2014, which provides that each Named
Executive Officer is eligible to receive options to acquire our Common Shares having a value, based on the Black-Scholes option pricing
model, equal to a specified multiple of his or her salary. The specified multiple for the President and Chief Executive Officer is 1.5.
The specified multiple for each other Named Executive Officer is 0.75. To encourage retention and focus management on developing and
successfully implementing our continuing growth strategy, stock options vest over a period of three years, with the first third vesting
on the first anniversary of the date of grant. Since the adoption of the Long-Term Incentive Plan in 2018, we have broadened the types
of equity-based awards which we may issue beyond stock options (to include, among other types, restricted stock units (“RSUs”),
DSUs and others).
Other
Forms of Compensation. Our executive employee benefits program also includes life, medical, dental and disability insurance to the
same extent and in the same manner as all other employees. Several of our executive officers also receive a car allowance as a perquisite.
These benefits and perquisites are designed to be competitive overall with equivalent positions in comparable North American organizations
in the life sciences industry. We also contribute to our North American employees’ retirement plans up to an annual maximum amount
of $19,500 for employees in the United States. The contribution amounts for our United States employees are subject to limitations imposed
by the United States Internal Revenue Service on contributions to our most highly compensated employees. Employees based in Frankfurt;
Germany also benefit from certain employer contributions into the employees’ pension funds. Our executive officers, including the
Named Executive Officers, are eligible to participate in such employer-contribution plans to the same extent and in the same manner as
all other employees.
Positioning
The
NGCC is authorized to engage its own independent consultant to advise it with respect to executive compensation matters. While the NGCC
may rely on external information and advice, all of the decisions with respect to executive compensation are made by the Board upon the
recommendation of the NGCC and may reflect factors and considerations other than, or that may differ from, the information and recommendations
provided by any external compensation consultants that may be retained from time to time.
In
2013, the NGCC retained a compensation consultant to benchmark our executive compensation plan in an effort to determine whether we were
achieving our objective of providing market competitive compensation opportunities. The compensation consultant gathered compensation
data from companies that it concluded were of comparable size and/or stage of development as us and from other companies with which we
compete for executive talent and advised the NGCC that our executive compensation should be generally aligned with the 50th percentile,
or the mid-point, of the companies surveyed by the consultant. Furthermore, the consultant advised the NGCC that the total cash target
payment (base salary and, if applicable or awarded in cash, annual bonus) for our executive officers in 2013 generally fell around the
50th percentile of the companies surveyed. The NGCC did not repeat or update the benchmarking process in 2014 – 2020 because it
concluded that doing so would not provide additional meaningful data, considering the expense of the process. However, the NGCC, as a
matter of good governance, annually reviews and assesses the Corporation’s current compensation program and makes appropriate adjustments,
if any.
Risk
Assessment of Executive Compensation Program
The
Board, through the NGCC, oversees the implementation of compensation methods that tie a portion of executive compensation to our short-term
and long-term performance and that of each executive officer and that take into account the advantages and risks associated with such
compensation methods. In addition, the Board oversees the creation of compensation policies that are intended to reward the creation
of shareholder value while reflecting a balance between our short-term and long-term performance and that of each executive officer.
The NGCC has considered in general terms the concept of risk as it relates to our executive compensation program.
Base
salaries are fixed in amount to provide a steady income to the executive officers regardless of share price and thus do not encourage
or reward risk-taking to the detriment of other important business, operational, commercial or clinical metrics or milestones. The variable
compensation elements (annual bonuses and equity-based awards) are designed to reward each of short-term, mid-term and long-term performance.
For short-term performance, a discretionary annual bonus may be awarded based on the timing and level of attainment of specific operational
and corporate goals that the NGCC believes to be challenging yet does not encourage unnecessary or excessive risk-taking. While our bonus
payments are generally based on annual performance, a maximum bonus payment is pre-fixed for each senior executive officer and represents
only a portion of each individual’s overall total compensation opportunities. In exceptional circumstances, a particular executive
officer may be awarded a bonus that exceeds his or her maximum pre-fixed or target bonus amount. Finally, a significant portion of executive
compensation is provided in the form of equity-based awards, which is intended to further align the interests of executives with those
of shareholders. The NGCC believes that these awards do not encourage unnecessary or excessive risk-taking since the ultimate value of
the awards is tied to our share price, and in the case of grants under the long-term incentive compensation plan, are generally subject
to mid-term and long-term vesting schedules to help ensure that executives generally have significant value tied to long-term share price
performance.
The
NGCC believes that the variable compensation elements (annual bonuses and equity-based awards) represent a percentage of overall compensation
that is sufficient to motivate our executive officers to produce superior short-term, mid-term and long-term corporate results, while
the fixed compensation element (base salary) is also sufficient to discourage executive officers from taking unnecessary or excessive
risks. The NGCC and the Board also generally have the discretion to adjust annual bonuses and equity-based awards based on individual
performance and any other factors they may determine to be appropriate in the circumstances. Such factors may include, where necessary
or appropriate, the level of risk-taking a particular executive officer may have engaged in during the preceding year.
Based
on the foregoing, the NGCC has not identified any specific risks associated with our executive compensation program that are reasonably
likely to have a material adverse effect on us. The NGCC believes that our executive compensation program does not encourage or reward
any unnecessary or excessive risk-taking behavior.
Our
directors, executive officers and employees are prohibited from purchasing, selling or otherwise trading in derivative securities relating
to our Common Shares. Derivative securities are securities whose value varies in relation to the price of our securities. Examples of
derivative securities include warrants to purchase our Common Shares, and put or call options written on our Common Shares, as well as
individually arranged derivative transactions, such as financial instruments, including, for greater certainty, prepaid variable forward
contracts, equity swaps, collars, or units of exchange funds, which are designed to hedge or offset a decrease in market value of our
equity securities granted as executive compensation or directors’ remuneration. Options to acquire our Common Shares and other
equity-based awards issued pursuant to the Stock Option Plan or Long-Term Incentive Plan are not derivative securities for this purpose.
2021
Compensation
Base
Salary. The primary element of our compensation program is base salary. Our view is that a competitive base salary is a necessary
element for retaining qualified executive officers. In determining individual base salaries, the NGCC takes into consideration individual
circumstances that may include the scope of an executive’s position, the executive’s relevant competencies or experience
and retention risk. The NGCC also takes into consideration the fulfillment of our corporate objectives, as well as the individual performance
of the executive.
Short-Term,
Non-Equity Incentive Compensation. The Board, based on the NGCC’s recommendation, adopted the following performance objectives
for 2021:
Goal
|
|
|
|
Result
|
Commercialization
of Macrilen™ (macimorelin) in Europe and the rest of the world |
|
Successfully
execute the Board-approved strategy and implementation plan to pursue commercialization opportunities for macimorelin for the rest
of the world. |
|
In
progress. The Company signed a distribution agreement, in June 2020, with MegaPharm Ltd. for Israel and the Palestinian Authority,
with Consilient Health in December 2020 for the United Kingdom and the European Union, with NK Meditech in December 2021 for South
Korea. The Company continues to explore opportunities in additional geographies. |
Commercialization
of Macrilen™ (macimorelin) in United States and Canada |
|
Ensure
effective clinical studies are in place to obtain approval of pediatric indication of Macrilen™ (macimorelin). |
|
In
progress. In November 2020, the Company executed an amendment to the License Agreement with Novo whereby the Company will
conduct the pivotal Study P02 as sponsor in partnership with a contract research organization. Study P02 was initiated in April 2021. |
Identify
and pursue cost-effective pipeline development projects to further growth strategy, including the therapeutic development potential
of Macrilen™ (macimorelin) |
|
|
|
During
2021, we in-licensed six new preclinical programs, four potential therapeutics (NMOSD, Parkinson’s Disease, Hypoparathyroidism
and ALS) and two potential vaccines (COVID-19 and Chlamydia Trachomatis). The ALS program aims at therapeutic use of macimorelin. |
Improve
operations |
|
Manage
costs and control expenses to maximize cash conservation. |
|
Ongoing
activity in progress. |
|
Ensure
appropriate capitalization of the Company. |
|
The
Company raised approximately $31.0 million with a public financing in February 2021 and approximately $20.1 million through the exercise
of warrants. |
Long-Term
Equity Compensation
For
the financial year ended December 31, 2021, the Board approved awards of a total of 580,000 stock options at an exercise price of $0.42
to employees of the Corporation on December 17, 2021 in accordance with the Long-Term Incentive Plan.
Summary
of the Stock Option Plan
We
established the Stock Option Plan in order to attract and retain directors, officers, employees and suppliers of ongoing services, who
will be motivated to work towards ensuring our success. The Board has full and complete authority to interpret the Stock Option Plan,
to establish applicable rules and regulations and to make all other determinations it deems necessary or useful for the administration
of the Stock Option Plan, provided that such interpretations, rules, regulations and determinations are consistent with the rules of
all stock exchanges and quotation systems on which our securities are then traded and with all relevant securities legislation.
There
were 141,400 options outstanding under the Stock Option Plan representing approximately 0% of all issued and outstanding Common Shares
as of December 31, 2021. The proposed number of Common Shares issuable pursuant to the Long-Term Incentive Plan is fixed at 11.4% of
the issued and outstanding Common Shares at any given time less the number of Common Shares issuable pursuant to stock options granted
at such time under the Stock Option Plan. See below for a complete description of the Long-Term Incentive Plan. As of December 31, 2020,
there were 246,619 Common Shares unallocated and available for future grants of options under the Stock Option Plan; however, the Corporation
does not intend on issuing any new stock options under the Stock Option Plan, and instead will issue any future stock options under the
Long-Term Incentive Plan.
The
burn rate for the Stock Option Plan for the most recently completed fiscal year is set out below:
Stock
Option Plan |
Year
End | |
Options
Granted | | |
Weighted
Average Shares Outstanding | | |
Burn
Rate(1) | |
December 31, 2021 | |
| 0 | | |
| 114,924,497 | | |
| 0 | % |
December 31, 2020 | |
| 0 | | |
| 41,083,163 | | |
| 0 | % |
December 31, 2019 | |
| 0 | | |
| 17,494,472 | | |
| 0 | % |
Notes:
(1) |
Annual burn rate is expressed
as a percentage and is calculated by dividing the number of securities granted under the Stock Option Plan by the weighted average
number of securities outstanding for the applicable fiscal year. |
Under
the Stock Option Plan, (i) the number of securities issuable to insiders, at any time, or issued within any one-year period, under all
of our security-based compensation arrangements, cannot exceed 10% of our issued and outstanding securities and (ii) no single person
eligible to receive grants under the Stock Option Plan (each a “Participant”) may hold options to purchase, from time
to time, more than 5% of our issued and outstanding Common Shares. In addition: (i) the aggregate fair value of options granted under
all of our security-based compensation arrangements to any one of our Outside Directors entitled to receive a benefit under the Stock
Option Plan, within any one-year period, cannot exceed $100,000 valued on a Black-Scholes basis and as determined by the NGCC; and (ii)
the aggregate number of securities issuable to all of our Outside Directors entitled to receive a benefit under the Stock Option Plan,
within any one-year period, under all of our security-based compensation arrangements, cannot exceed 1% of its issued and outstanding
securities.
Options
granted under the Stock Option Plan may be exercised at any time within a maximum period of seven or ten years following the date of
their grant (the “Outside Expiry Date”), depending on the date of grant. The Board or the NGCC, as the case may be,
designates, at its discretion, the specific Participants to whom stock options are granted under the Stock Option Plan and determines
the number of Common Shares covered by each of such option grants, the grant date, the exercise price of each option, the Outside Expiry
Date and any other matter relating thereto, in each case in accordance with the applicable rules and regulations of the regulatory authorities.
The price at which the Common Shares may be purchased may not be lower than the greater of the closing prices of the Common Shares on
the NASDAQ on the last trading day preceding the date of grant of the option. Options granted under the Stock Option Plan shall vest
in equal tranches over a three-year period (one-third each year, starting on the first anniversary of the grant date) or as otherwise
determined by the Board or the NGCC, as the case may be. Participants may not assign their options (nor any interest therein) other than
by will or in accordance with the applicable laws of estates and succession.
Unless
the Board or the NGCC decides otherwise, Participants cease to be entitled to exercise their options under the Stock Option Plan: (i)
immediately, in the event a Participant who is an officer or employee resigns or voluntarily leaves his or her employment or his or her
employment is terminated with cause and, in the case of a Participant who is a non-employee director of us or one of our subsidiaries,
the date on which such Participant ceases to be a member of the relevant Board; (ii) six months following the date on which employment
is terminated as a result of the death of a Participant who is an officer or employee and, in the case of a Participant who is an Outside
Director, six months following the date on which such Participant ceases to be a member of the Board by reason of death; (iii) 90 days
following the date on which a Participant’s employment is terminated for a reason other than those mentioned in (i) or (ii) above
including, without limitation, upon the disability, long-term illness, retirement or early retirement of the Participant; and (iv) where
the Participant is a service supplier, 30 days following the date on which such Participant ceases to act as such, for any cause or reason
(each, an “Early Expiry Date”).
The
Stock Option Plan also provides that, if the expiry date of one or more options (whether an Early Expiry Date or an Outside Expiry Date)
occurs during a “blackout period” or within the seven business days immediately after a blackout period imposed by us, the
expiry date will be automatically extended to the date that is seven business days after the last day of the blackout period. For the
purposes of the foregoing, “blackout period” means the period during which trading in our securities is restricted in accordance
with our corporate policies.
If
(i) we accept an offer to amalgamate, merge or consolidate with any other entity (other than one of our wholly-owned subsidiaries) or
to sell or license all or substantially all of our assets to any other entity (other than one of our wholly-owned subsidiaries); (ii)
we sign a support agreement in customary form pursuant to which the Board agrees to support a takeover bid and recommends that our shareholders
tender their Common Shares to such takeover bid; or (iii) holders of more than 50% of our then outstanding Common Shares tender all of
their Common Shares to a takeover bid made to all of the holders of the Common Shares to purchase all of the then issued and outstanding
Common Shares, then, in each case, all of the outstanding options shall, without any further action required to be taken by us, immediately
vest. Each Participant shall thereafter be entitled to exercise all of such options at any time up to and including, but not after the
close of business on that date which is ten days following the Closing Date (as defined below). Upon the expiration of such ten-day period,
all rights of the Participant to such options or to the exercise of same (to the extent not already exercised) shall automatically terminate
and have no further force or effect whatsoever. “Closing Date” is defined to mean (x) the closing date of the amalgamation,
merger, consolidation, sale or license transaction in the case of clause (i) above; (y) the first expiry date of the takeover bid on
which each of the offeror’s conditions are either satisfied or waived in the case of clause (ii) above; or (z) the date on which
it is publicly announced that holders of greater than 50% of our then outstanding Common Shares have tendered their Common Shares to
a takeover bid in the case of clause (iii) above.
The
Stock Option Plan provides that the following amendments may be made to the plan only upon approval of each of the Board and our shareholders
as well as receipt of all required regulatory approvals:
●
any amendment to Section 3.2 of the Stock Option Plan (which sets forth the limit on the number of options
that may be granted to insiders) that would have the effect of permitting, without having to obtain shareholder approval on a “disinterested
vote” at a duly convened shareholders’ meeting, the grant of any option(s) under the Stock Option Plan otherwise prohibited
by Section3.2;
●
any amendment to the number of securities issuable under the Stock Option Plan (except for certain permitted
adjustments, such as in the case of stock splits, consolidations or reclassifications);
●
any amendment that would permit any option granted under the Stock Option Plan to be transferable or assignable
other than by will or in accordance with the applicable laws of estates and succession;
●
the addition of a cashless exercise feature, payable in cash or securities, which does not provide for
a full deduction of the number of underlying securities from the Stock Option Plan reserve;
●
the addition of a deferred or restricted share unit component or any other provision that results in employees
receiving securities while no cash consideration is received by us;
●
with respect to any Participant, whether or not such Participant is an “insider” and except in respect of certain permitted
adjustments, such as in the case of stock splits, consolidations or reclassifications:
●
any reduction in the exercise price of any option after the option has been granted; or
●
any cancellation of an option and the re-grant of that option under different terms;
●
any extension to the term of an option beyond its Outside Expiry Date to a Participant who is an “insider”
(except for extensions made in the context of a “blackout period”);
●
any amendment to the method of determining the exercise price of an option granted pursuant to the Stock
Option Plan;
●
the addition of any form of financial assistance or any amendment to a financial assistance provision which
is more favorable to employees; and
●
any amendment to the foregoing amending provisions requiring Board, shareholder and regulatory approvals.
The
Stock Option Plan further provides that the following amendments may be made to the Stock Option Plan upon approval of the Board and
upon receipt of all required regulatory approvals, but without shareholder approval:
●
amendments of a “housekeeping” or clerical nature or to clarify the provisions of the Stock
Option Plan;
●
amendments regarding any vesting period of an option;
●
amendments regarding the extension of an option beyond an Early Expiry Date in respect of any Participant,
or the extension of an option beyond the Outside Expiry Date in respect of any Participant who is a “non-insider”;
●
adjustments to the number of issuable Common Shares underlying, or the exercise price of, outstanding options resulting from a split
or a consolidation of the Common Shares, a reclassification, the payment of a stock dividend, the payment of a special cash or non-cash
distribution to our shareholders on a pro rata basis provided such distribution is approved by our shareholders in accordance
with applicable law, a recapitalization, a reorganization or any other event which necessitates an equitable adjustment to the outstanding
options in proportion with corresponding adjustments made to all outstanding Common Shares;
●
discontinuing or terminating the Stock Option Plan; and any other amendment which does not require
shareholder approval under the terms of the Stock Option Plan.
Summary
of the Long-Term Incentive Plan
The
purpose of the Long-Term Incentive Plan is to (i) promote our long-term financial interests and growth by attracting and retaining management
and other personnel and key service providers with the training, experience and ability to enable them to make a substantial contribution
to the success of our business; (ii) motivate management personnel by means of growth-related incentives to achieve long-range goals;
and (iii) further the alignment of interests of participants with those of our shareholders through opportunities for increased share
ownership in the Corporation.
The
NGCC is the administrator of the Long-Term Incentive Plan (the “Administrator”). At any time, the Board may serve
as the Administrator of the Long-Term Incentive Plan, in lieu of, or in addition, to the NGCC. Except as provided otherwise under the
Long-Term Incentive Plan, the Administrator has plenary authority to grant awards pursuant to the terms of the Long-Term Incentive Plan
to eligible individuals, determine the types of awards and the number of shares to be covered by the awards, establish the terms and
conditions for awards, including the exercise price and term of awards, and take all other actions necessary or desirable to carry out
the purpose and intent of the Long-Term Incentive Plan.
Participation
in the Long-Term Incentive Plan is generally open to all officers, employees and other individuals, including Outside Directors. However,
any individual whose services to the Corporation or any of its subsidiaries are limited to capital-raising transactions, or the promotion
and maintenance of a market for the Corporation securities, are ineligible to participate in the Long-Term Incentive Plan. Prospective
officers, employees and other service providers who have accepted offers to provide services to the Corporation may also participate
in the Long-Term Incentive Plan.
The
Long-Term Incentive Plan enables the grant of stock options, stock appreciation rights (“SARs”), stock awards, stock
unit awards, performance shares, cash-based performance units and other stock-based awards, each of which may be granted separately or
in tandem with other awards.
The
maximum number of Common Shares issuable under the Long-Term Incentive Plan is fixed at 11.4% of the issued and outstanding Common Shares
at any given time, less the number of Common Shares issuable pursuant to stock options granted at such time under the Stock Option Plan.
There were 1,367,968 awards outstanding under the Long-Term Incentive Plan representing approximately 1.1% of all issued and outstanding
Common Shares as of December 31, 2021. As of December 31, 2021, there were 12,329,890 Common Shares unallocated and available for future
grants of awards that are settled in Common Shares under the Long-Term Incentive Plan. See above for a complete description of the Stock
Option Plan.
The
burn rate for the LTIP for the most recently completed fiscal year is set out below:
LTIP |
Year
End | |
Awards
Granted | | |
Weighted
Average Shares Outstanding | | |
Burn
Rate(1) | |
December 31, 2021 | |
| 860,000 | | |
| 114,924,497 | | |
| 0.7 | % |
December 31, 2020 | |
| 300,000 | | |
| 41,083,163 | | |
| 0.7 | % |
December 31, 2019 | |
| 335,000 | | |
| 17,494,472 | | |
| 1.9 | % |
Notes:
(1) |
Annual
burn rate is expressed as a percentage and is calculated by dividing the number of securities granted under the LTIP by the weighted
average number of securities outstanding for the applicable fiscal year. |
The
number of securities issuable to insiders, at any time, or issued within any one-year period, under all of our security-based compensation
arrangements, cannot exceed 10% of our issued and outstanding securities and no single participant may hold options to purchase, from
time to time, more than 5% of our issued and outstanding Common Shares.
The
aggregate fair value of options granted under all of our security-based compensation arrangements to any one of our Outside Directors
entitled to receive a benefit under the Long-Term Incentive Plan, within any one-year period, cannot exceed $100,000 valued on a Black-Scholes
basis and as determined by the NGCC; and the aggregate number of securities issuable to all of our Outside Directors entitled to receive
a benefit under the Long-Term Incentive Plan, within any one-year period, under all of our security-based compensation arrangements,
cannot exceed 1% of its issued and outstanding securities.
Except
as provided below or within an award agreement, each award granted under the Long-Term Incentive Plan (other than a performance unit
that cannot be paid in shares) will be subject to a minimum vesting period or minimum restriction period as follows: (i) each stock option
or SAR will be subject to a minimum vesting period of 12 months from the date of grant, (ii) each award of stock, stock units, performance
shares, performance units payable in shares and other stock- based awards (“Full Value Awards”) granted to non-employee
directors will be subject to a minimum restriction period of 12 months from the date of grant, and (iii) each Full Value Award granted
to a participant other than a non-employee director will be subject to a minimum restriction period of 12 months from the date of grant
if vesting of or lapse of restrictions on such award is based on the satisfaction of performance goals and a minimum restriction period
of 36 months from the date of grant, applied in either pro rata installments or a single installment, if vesting of or lapse of restrictions
on such award is based solely on the participant’s satisfaction of specified service requirements with us (provided that no such
Full Value Awards will vest or have its restrictions lapse during the first 12 months following the date of grant). If the grant of a
performance award is conditioned on satisfaction of performance goals, the performance period must not be less than 12 months’
duration, but no additional minimum restriction period need apply to such award. The minimum vesting period or minimum restriction period
will not apply in the case of death or disability of a participant or in the event of a change in control. Awards that result in the
issuance of an aggregate of up to 5% of the share pool under the Long-Term Incentive Plan may be granted without regard to such minimum
vesting period or minimum restriction period.
A
SAR is the right to receive a payment equal to the excess of the Fair Market Value (as defined below) of a specified number of shares
on the date the SAR is exercised over the base price per share specified in the award agreement. The base price for each SAR cannot be
less than 100% of the Fair Market Value of Common Shares on the grant date and the term of a SAR cannot be more than 10 years from the
grant date, unless required otherwise by applicable law. At the discretion of the Administrator, the payment upon a SAR exercise may
be in cash, shares or a combination of the two. The “Fair Market Value” means the official closing price per Common Share
for the regular market session on the day of determination.
Awards
granted under the Long-Term Incentive Plan shall not be subject in any manner to alienation, anticipation, sale, transfer, assignment,
pledge, or encumbrance, except as otherwise determined by the Administrator; provided, however, that this restriction shall not apply
to the Common Shares received in connection with an award after the date that the restrictions on transferability of such shares set
forth in the applicable award agreement have lapsed.
Except
as provided in the applicable award agreement or otherwise determined by the Administrator, and subject to the minimum vesting period
or minimum restriction period described above, upon termination of service (as defined in the Long-Term Incentive Plan):
●
Stock options or stock appreciation rights shall be forfeited, to the extent stock options or stock appreciation
rights are not vested and exercisable;
●
During the applicable restriction period, restricted stock and any accrued but unpaid dividends that are at that time subject to restrictions
shall be forfeited; and
●
During the applicable deferral period or portion thereof to which forfeiture conditions apply, or upon failure to satisfy any other conditions
precedent to the delivery of Common Shares or cash to which RSUs, performance shares or performance units relate, all performance shares,
performance units and RSUs and any other accrued but unpaid dividend equivalents with respect to such RSUs that are then subject to deferral
or restriction shall be forfeited.
In
the event of a change in control (as defined in the Long-Term Incentive Plan) of the Corporation, outstanding awards will terminate upon
the effective time of the change in control unless provision is made for the continuation, assumption or substitution of awards by the
surviving or successor entity or its parent. Unless an award agreement says otherwise, the following will occur with respect to awards
that terminate in connection with a change in control of the Corporation:
●
stock options and SARs, whether vested or unvested, will become fully exercisable and holders of these awards will be permitted immediately
before the change in control to exercise them;
●
restricted stock and RSUs with time-based vesting (i.e., not subject to achievement of performance goals) will become fully vested immediately
before the change in control, and RSUs will be settled as promptly as is practicable in accordance with applicable law; and
●
restricted stock, RSUs, performance shares, and performance units that vest based on the achievement of performance goals will become
fully vested and earned based on the target performance level as to the performance goals, such that 100% of the target award is earned
as of the date of the change of control; and the RSUs and performance units will be settled as promptly as is practicable in accordance
with applicable law. The Long-Term Incentive Plan will terminate on the earlier of (i) the earliest date as of which all awards granted
under the Long-Term Incentive Plan have been satisfied in full or terminated and no shares approved for issuance under the Long-Term
Incentive Plan remain available to be granted under new awards, or (ii) the tenth anniversary of date the Long-Term Incentive Plan, as
amended and restated, is approved by our shareholders.
The
Administrator may amend, alter or discontinue the Long-Term Incentive Plan, but no amendment, alteration or discontinuation will be made
that would materially impair the rights of a participant with respect to a previously granted award without his or her consent, except
such an amendment made to comply with applicable law or rule of any securities exchange or market on which our Common Shares are listed
or admitted for trading or to prevent adverse tax or accounting consequences to the Corporation or the participant. In no event, however,
will an amendment be made without the approval of our shareholders to the extent such amendment would (i) materially increase the benefits
accruing to participants under the Long-Term Incentive Plan, (ii) increase the number of shares that may be issued under the Long-Term
Incentive Plan or to a participant, (iii) materially expand the eligibility for participation in the Long-Term Incentive Plan, (iv) eliminate
or modify the prohibition on repricing of stock options and SARs, (v) lengthen the maximum term or lower the minimum exercise price or
base price permitted for stock options and SARs, (vi) modify the prohibition on the issuance of reload or replenishment options, (vii)
amend the amendment provisions in the Long-Term Incentive Plan, or (viii) amend the Long-Term Incentive Plan to remove or exceed the
10% insider participation limit.
Outstanding
Option-Based Awards and Share-Based Awards
The
following table shows all awards outstanding to our Named Executive Officers as of December 31, 2021:
|
|
Option-based
Awards |
|
Share-based
Awards |
|
Name |
|
Issuance
Date
(mm/dd/yyyy) |
|
Number
of Securities Underlying Unexercised Options(1)
(#) |
|
|
Option
Exercise Price
($) |
|
|
Option
Expiration Date
(mm/dd/yyyy) |
|
|
Value
of Unexercised In-the- money Options(2)
($) |
|
|
Issuance
Date |
|
|
Number
of Shares or Units of shares
that
have Not Vested (#) |
|
|
Market
or Payout
Value
of Share- based
Awards
that have Not Vested ($) |
|
|
Market
or payout value of vested share-based awards not paid out or distributed
($) |
|
Paulini, Klaus |
|
12/06/2016 |
|
|
2,500 |
|
|
|
3.45 |
|
|
|
12/06/2023 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
08/15/2019 |
|
|
25,000 |
|
|
|
2.15 |
|
|
|
08/15/2026 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
11/11/2019 |
|
|
35,000 |
|
|
|
1.05 |
|
|
|
11/11/2026 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/14/2020 |
|
|
35,000 |
|
|
|
0.366 |
|
|
|
12/14/2027 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/17/2021 |
|
|
100,000 |
|
|
|
0.42 |
|
|
|
12/17/2028 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Auld, Leslie |
|
— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/21/2015 |
|
|
5,000 |
|
|
|
4.58 |
|
|
|
12/21/2022 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Gerlach, Matthias |
|
12/06/2016 |
|
|
15,000 |
|
|
|
3.45 |
|
|
|
12/06/2023 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/04/2019 |
|
|
20,000 |
|
|
|
0.87 |
|
|
|
12/04/2026 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/14/2020 |
|
|
25,000 |
|
|
|
0.366 |
|
|
|
12/14/2027 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/17/2021 |
|
|
50,000 |
|
|
|
0.42 |
|
|
|
12/17/2028 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/21/2015 |
|
|
5,000 |
|
|
|
4.58 |
|
|
|
12/21/2022 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
11/08/2016 |
|
|
398 |
|
|
|
3.50 |
|
|
|
11/08/2023 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Guenther, Eckhard |
|
12/06/2016 |
|
|
10,000 |
|
|
|
3.45 |
|
|
|
12/06/2023 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/04/2019 |
|
|
25,000 |
|
|
|
0.87 |
|
|
|
12/04/2026 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/14/2020 |
|
|
25,000 |
|
|
|
0.366 |
|
|
|
12/14/2027 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/17/2021 |
|
|
50,000 |
|
|
|
0.42 |
|
|
|
12/17/2027 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/06/2016 |
|
|
10,000 |
|
|
|
3.45 |
|
|
|
12/06/2023 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Ammer, Nicola |
|
12/04/2019 |
|
|
25,000 |
|
|
|
0.87 |
|
|
|
12/04/2026 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/14/2020 |
|
|
25,000 |
|
|
|
0.366 |
|
|
|
12/14/2027 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12/17/2021 |
|
|
50,000 |
|
|
|
0.42 |
|
|
|
12/17/2027 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
(1)
The number of securities underlying unexercised options represents all awards outstanding at December 31, 2021.
(2)
“Value of unexercised in-the-money options” at financial year-end is calculated based on the difference between the closing
price of the Common Shares on the NASDAQ on the last trading day of the fiscal year (December 31, 2021) of $0.36 and the exercise price
of the options, multiplied by the number of unexercised options.
There
were no share-based awards outstanding to our Named Executive Officers at December 31, 2021.
Incentive
Plan Awards - Value Vested or Earned During the Year
The
following table shows the incentive plan awards value vested or earned for each Named Executive Officer for the financial year ended
December 31, 2021:
Name | |
Option-based
awards — Value
vested during the year(1) ($) | | |
Share-based
awards — Value
vested during the year ($) | | |
Non-equity
incentive plan compensation — Value earned during the year(2) ($) | |
Paulini, Klaus | |
| — | | |
| — | | |
| 162,530 | |
Auld, Leslie | |
| — | | |
| — | | |
| — | |
Gerlach, Matthias | |
| — | | |
| — | | |
| 55,319 | |
Guenther, Eckhard | |
| — | | |
| — | | |
| 67,021 | |
Ammer, Nicola | |
| — | | |
| — | | |
| 53,191 | |
|
(1) |
Represents
the aggregate dollar value that would have been realized if the options had been exercised on the vesting date, based on the difference
between the closing price of the Common Shares on the NASDAQ and the exercise price on such vesting date. If closing price of the
Common Shares on the NASDAQ on the vesting date was lower than the exercise price, then $nil was considered realized. |
|
|
|
|
(2) |
During
2021, each of Dr. Paulini, Dr. Gerlach, Dr. Guenther and Dr. Ammer were paid bonuses granted in 2021 for activities related to 2020
and will be paid in 2022 bonuses granted in 2020 for activities related to 2021. |
Summary
Compensation Table
The
Summary Compensation Table set forth below shows compensation information for each of the Named Executive Officers for services rendered
in all capacities during each of the financial years ended December 31, 2021, 2020 and 2019. All amounts in the table below are in U.S.
dollars. Ms. Auld’s cash payments were made in Canadian dollars. All cash amounts paid to Dr. Paulini, Dr. Guenther, Dr. Gerlach
and Dr. Ammer were made in Euros.
SUMMARY
COMPENSATION TABLE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-equity
incentive plan compensation(1) |
|
|
|
|
|
|
|
|
|
|
Name
and principal position |
|
Years |
|
|
Salary
($) |
|
|
Share
based awards
($) |
|
|
Option
based awards
($) |
|
|
Annual
incentive plan
($) |
|
|
Long-
term incentive plans
($) |
|
|
Pension
Value
($)(2) |
|
|
All
other compensation ($) |
|
|
Total
compensation ($) |
|
Paulini,
Klaus(3)
President and Chief Executive |
|
|
2021 |
|
|
|
374,496 |
|
|
|
— |
|
|
|
35,298 |
|
|
|
162,530 |
|
|
|
— |
|
|
|
213,700 |
|
|
|
— |
|
|
|
786,024 |
|
Officer;
Managing |
|
|
2020 |
|
|
|
306,086 |
|
|
|
— |
|
|
|
9,503 |
|
|
|
183,580 |
|
|
|
— |
|
|
|
292,983 |
|
|
|
— |
|
|
|
792,152 |
|
Director
AEZS Germany |
|
|
2019 |
|
|
|
197,282 |
|
|
|
— |
|
|
|
66,781 |
|
|
|
22,400 |
|
|
|
— |
|
|
|
191,572 |
|
|
|
— |
|
|
|
478,035 |
|
Auld,
Leslie |
|
|
2021 |
|
|
|
163,038 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
163,038 |
|
Senior
Vice President, |
|
|
2020 |
|
|
|
166,834 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
166,834 |
|
Chief
Financial Officer |
|
|
2019 |
|
|
|
194,060 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
194,060 |
|
Guenther,
Eckhard
Senior Vice President Business Development and Alliance |
|
|
2021 |
|
|
|
238,737 |
|
|
|
— |
|
|
|
17,649 |
|
|
|
67,021 |
|
|
|
— |
|
|
|
5,019 |
|
|
|
— |
|
|
|
328,426 |
|
Management;
Managing |
|
|
2020 |
|
|
|
218,966 |
|
|
|
— |
|
|
|
6,788 |
|
|
|
85,460 |
|
|
|
— |
|
|
|
97,937 |
|
|
|
— |
|
|
|
409,151 |
|
Director
AEZS Germany |
|
|
2019 |
|
|
|
169,438 |
|
|
|
— |
|
|
|
14,792 |
|
|
|
12,443 |
|
|
|
— |
|
|
|
124,866 |
|
|
|
— |
|
|
|
321,539 |
|
Gerlach,
Matthias
Senior Vice |
|
|
2021 |
|
|
|
203,276 |
|
|
|
— |
|
|
|
17,649 |
|
|
|
55,319 |
|
|
|
— |
|
|
|
16,314 |
|
|
|
— |
|
|
|
292,558 |
|
President
Manufacturing |
|
|
2020 |
|
|
|
185,379 |
|
|
|
— |
|
|
|
6,788 |
|
|
|
70,810 |
|
|
|
— |
|
|
|
14,827 |
|
|
|
— |
|
|
|
277,803 |
|
and
Supply Chain |
|
|
2019 |
|
|
|
159,862 |
|
|
|
— |
|
|
|
11,834 |
|
|
|
22,400 |
|
|
|
— |
|
|
|
11,368 |
|
|
|
— |
|
|
|
205,464 |
|
Ammer,
Nicola
Chief Medical Officer and |
|
|
2021 |
|
|
|
182,787 |
|
|
|
— |
|
|
|
17,649 |
|
|
|
53,191 |
|
|
|
— |
|
|
|
2,400 |
|
|
|
— |
|
|
|
256,027 |
|
Senior
Vice President |
|
|
2020 |
|
|
|
154,512 |
|
|
|
— |
|
|
|
6,788 |
|
|
|
64,880 |
|
|
|
— |
|
|
|
2,266 |
|
|
|
— |
|
|
|
228,446 |
|
Clinical
Development |
|
|
2019 |
|
|
|
139,802 |
|
|
|
— |
|
|
|
14,792 |
|
|
|
20,608 |
|
|
|
— |
|
|
|
2,164 |
|
|
|
— |
|
|
|
177,366 |
|
(1)
Non-equity incentive plan compensation includes cash bonuses. During 2021, each of Dr. Paulini, Dr. Gerlach, Dr. Guenther and Dr. Ammer
were paid for bonuses granted in 2020 for activities related to 2020 and will be paid in 2022 bonuses granted in 2021 for activities
related to 2021.
(2)
Dr. Paulini and Dr. Guenther participate in the DUPK (as defined below), a defined-contribution pension plan maintained by Unterstützungskasse
Degussa e.V. that was introduced for employees who began their employment with AEZS Germany (or its predecessors) prior to December 31,
1999. The DUPK includes indirect obligations through a funded multi-employer contribution plan as well as direct unfunded defined benefit
plans obligations. Dr. Gerlach participates in RUK 1 (as defined below), a defined-contribution pension plan maintained by Unterstützungskasse
Degussa e.V. Dr. Ammer participates in RUK 2 (as defined below), a defined-contribution pension plan maintained by Unterstützungskasse
Degussa e.V.
(3)
Dr. Paulini did not receive any compensation in his role as a managing director of GmbH or as an executive director.
The
value of option-based awards set out in the table above represents the closing price of the Common Shares on the NASDAQ on the last trading
day preceding the date of grant multiplied by the Black-Scholes factor as at such date and the number of stock options granted on such
date. For 2021, the Black-Scholes valuation model values the options based on the following assumptions: a 5.71-year expected life, 115.80%
expected volatility, risk-free annual interest rate of 1.23% per annum and an expected dividend yield of 0%. See the consolidated financial
statements for the Corporation for the years ended December 31, 2019, 2018 and 2017 and for the years ended December 31, 2018, 2017 and
2016 for the assumptions applied to the Black-Scholes option pricing model in previous years. The Corporation used the Black-Scholes
valuation model as it most accurately captured the fair value of such options. The following table sets forth the value of the option-based
awards and the corresponding Black-Scholes factor:
Date
of Grant | |
Value
of Grant | | |
Black-Scholes
Factor | |
November 9, 2016 | |
$ | 3.50 | | |
| 80.35 | % |
December 6, 2016 | |
$ | 3.45 | | |
| 80.57 | % |
December 16, 2016 | |
$ | 3.80 | | |
| 80.68 | % |
August 15, 2017 | |
$ | 2.05 | | |
| 78.86 | % |
April 2, 2018 | |
$ | 1.46 | | |
| 77.57 | % |
June 22, 2018 | |
$ | 2.11 | | |
| 80.86 | % |
August 15, 2019 | |
$ | 2.15 | | |
| 79.22 | % |
November 11, 2019 | |
$ | 1.05 | | |
| 67.13 | % |
December 4, 2019 | |
$ | 0.87 | | |
| 68.01 | % |
December 14, 2020 | |
$ | 0.366 | | |
| 74.19 | % |
December 17, 2021 | |
$ | 0.42 | | |
| 83.94 | % |
Compensation
of the Chief Executive Officer
The
compensation of our President and Chief Executive Officer is governed by our executive compensation policy described in the section titled
“Compensation of Executive Officers”, and the President and Chief Executive Officer participates, together with the other
Named Executive Officers, in all our incentive plans.
Dr.
Paulini’s total earnings during the financial year ended December 31, 2021 was $786,023, including an incentive bonus in the amount
of $162,530.
For
the financial year ended December 31, 2021, the Board approved an award of 100,000 stock options at an exercise price of $0.42 to Dr.
Paulini on December 17, 2021 in accordance with the Long-Term Incentive Plan.
See
“Long-Term Equity Compensation Plan of Executive Officers - Summary of the Stock Option Plan”, for a complete description
of the Stock Option Plan. See “Long-Term Equity Compensation Plan of Executive Officers - Summary of the Long-Term Incentive Plan”,
for a complete description of the Long-Term Incentive Plan.
Pension,
retirement or similar benefits
Each
of our Named Executive Officers who are employed with AEZS Germany participate in defined-contribution pension plans. The terms of these
pension plans are described below.
Degussa
Pensionskasse (“DUPK”)
Dr.
Paulini and Dr. Guenther participate in the DUPK, a defined-contribution pension plan maintained by Unterstützungskasse Degussa
e.V. that was introduced for employees who began their employment with AEZS Germany (or its predecessors) prior to December 31, 1999.
The DUPK includes indirect obligations through a funded multi-employer contribution plan as well as direct unfunded defined benefit plans
obligations.
Under
the funded multi-employer contribution portion of the DUPK, the contributions by AEZS Germany and the employee are calculated based on
the employee’s total salary during the prior year. The employee contributes 2% of his or her monthly average salary and AEZS Germany
contributes an amount of 1.784 times the employee’s contribution. The contributions are limited to the social security contribution
assessment ceiling. In 2021, the social security contribution assessment ceiling is €7,100 per month. Accordingly,
the employee will contribute at most €142.00 monthly and AEZS Germany will contribute at most €253.33 monthly.
Under
the unfunded defined benefit portion of the DUPK, the employee earns additional claims for future pension payments for the part of the
employee’s salary that exceeds the social security contribution assessment ceiling (“Supplementary Pensions”)
that are unfunded and are presented as a pensions benefit obligation on the balance sheet of the Company. The Supplementary Pensions
amount to 1.25% annually of a fictional salary peak, which is a percentage of the social security contribution assessment ceiling. Further,
the employee is entitled to annual Christmas benefits (“Christmas Benefits”), which amount to 1.4% of the last pensionable
monthly income for each year of service, limited by the social security contribution assessment ceiling. The employee’s contribution
and AEZS Germany’s contribution are transferred monthly to the pension fund, and AEZS Germany’s contribution is calculated
with the salary payments and treated as provision for pension payment. We are liable to the employees for the pension benefits that have
been promised if the private pension provider does not, or cannot, pay the promised pension payments. Employees will receive a pension
payment based on the contributions that were made during their employment, and will also receive the Supplementary Pensions and Christmas
Benefits, after they have reached the statutory retirement age, independent of whether they work with AEZS Germany until such age. All
direct pension obligations as well as pension obligations from deferred compensation are included and have been included in the pensions
benefit obligation of the Company.
Rückgedeckte
Unterstützungskasse 1 (“RUK 1”)
Dr.
Gerlach participates in RUK 1, a defined-contribution pension plan maintained by Unterstützungskasse Degussa e.V. Under RUK 1, AEZS
Germany contributes 2.4% of Dr. Gerlach’s monthly gross salary and Dr. Gerlach contributes 2% of his monthly gross salary. The
contributions are limited to the social security contribution assessment ceiling. However, AEZS Germany provides an additional contribution
of 18% of his monthly gross salary for the part of his salary that exceeds the social security contribution assessment ceiling. In 2021,
the social security contribution assessment ceiling is €7,100 per month. Accordingly, AEZS Germany will contribute at
most €1,232.40 (which includes the additional contribution of 18%) monthly and Dr. Gerlach will contribute at most €142.00
monthly. Both contributions are calculated with the monthly salary accounting and transferred to the relief fund monthly. We are
liable to Dr. Gerlach for the pension benefits that have been promised if the private pension provider does not, or cannot, pay the promised
pension payments. Dr. Gerlach will receive a pension payment based on the contributions that were made during his employment after he
has reached the statutory retirement age, independent of whether he works with AEZS Germany until such age.
Rückgedeckte
Unterstützungskasse 2 (“RUK 2”)
Dr.
Ammer participates in RUK 2, a defined-contribution pension plan maintained by Unterstützungskasse Degussa e.V. Under RUK 2, AEZS
Germany contributes 2.4% of Dr. Ammer’s monthly gross salary and Dr. Ammer contributes 3% of her monthly gross salary. The contributions
are limited to the social security contribution assessment ceiling. In 2021, the social security contribution assessment ceiling
is €7,100 per month. Accordingly, AEZS Germany will contribute at most €170.40 monthly and Dr. Ammer will contribute
at most €213.00 monthly. Both contributions are calculated with the monthly salary accounting and transferred to the relief
fund monthly. We are liable to Dr. Ammer for the pension benefits that have been promised if the private pension provider does not, or
cannot, pay the promised pension payments. Dr. Ammer will receive a pension payment based on the contributions that were made during
her employment after she has reached the statutory retirement age, independent of whether she works with AEZS Germany until such age.
***
The
table below includes the following information about each Named Executive Officer participating in the DUPK, the Company’s only
benefit plan with a defined benefit component:
|
● |
years of credited service
as at December 31, 2021; |
|
|
|
|
● |
estimated annual benefit
accrued, or earned, for service to December 31, 2021 and to the normal retirement age of 65; and |
|
|
|
|
● |
a reconciliation of the accrued
obligation from December 31, 2020 to December 31, 2021. |
|
|
Number of
years |
|
|
Annual
benefits
payable ($)(2) |
|
|
Opening
present
value
of
defined |
|
|
Compensatory |
|
|
Non- |
|
|
Closing
present
value
of
defined |
|
Name |
|
credited
service
(#)(1) |
|
|
At
year end |
|
|
At
age 65 |
|
|
benefit
obligation
($)(3) |
|
|
change
($)(4) |
|
|
compensatory
change
($) |
|
|
benefit
obligation ($)(3) |
|
Paulini, Klaus |
|
|
24 |
|
|
|
34,085 |
|
|
|
104,447 |
|
|
|
855,633 |
|
|
|
210,131 |
|
|
|
31,548 |
|
|
|
1,097,312 |
|
Guenther, Eckhard |
|
|
31 |
|
|
|
54,219 |
|
|
|
54,219 |
|
|
|
899,891 |
|
|
|
1,450 |
|
|
|
33,180 |
|
|
|
934,521 |
|
(1)
The number of years of credited service as at December 31, 2021 corresponds to the actual years of service with AEZS Germany.
(2)
For each Named Executive Officer, the amount of annual benefits payable at December 31, 2021 is the pension the Named Executive Officer
would be entitled to starting at age 65 based on termination of employment at December 31, 2021. For each Named Executive Officer, the
annual benefits payable at age 65 is the annual benefits payable at December 31, 2021 increased to reflect estimated credited service
at age 65.
(3)
The present value is the estimated value of the pension obligation to the date indicated using the actuarial assumptions and methods
that are consistent with those used in determining pension liabilities as disclosed in the Company’s consolidated financial statements.
(4)
Compensatory change represents the change in the pension liability between December 31, 2020 and 2021 for each Named Executive Officer.
(5)
The calculations of reported amounts use the same actuarial assumptions and methods that are used for calculating accrued benefit obligations
and annual expenses, as disclosed in the Company’s 2021 and 2020 consolidated financial statements in Note 18, and as prescribed
by International Financial Reporting Standards. The methods and assumptions used to determine estimated amounts will not be identical
to the methods and assumptions used by other issuers so, as a result, the figures may not be directly comparable across issuers. All
amounts shown above are based on assumptions and represent contractual entitlements that may change over time.
The
table below includes amounts from AEZS Germany’s defined-contribution plans. Any difference between (i) the sum of the Accumulated
Value at Start of Year column plus the Compensatory column and (ii) the Accumulated Value at End of Year column is attributable to the
employee’s contributions to the pension plan during the year ended December 31, 2021, as well as changes in the foreign exchange
rate, each employee’s contributions being made in Euros.
Name | |
Accumulated
value at start of year ($) | | |
Compensatory ($) | | |
Accumulated
value at year end ($) | |
Paulini, Klaus | |
| 96,086 | | |
| 3,569 | | |
| 105,229 | |
Gerlach, Matthias | |
| 212,972 | | |
| 16,314 | | |
| 239,090 | |
Guenther, Eckhard | |
| 116,059 | | |
| 3,569 | | |
| 125,895 | |
Ammer, Nicola | |
| 25,784 | | |
| 5,400 | | |
| 32,128 | |
Our
Articles provide that our Board shall be composed of a minimum of five (5) and a maximum of fifteen (15) directors. Directors are elected
annually by our shareholders, but the directors may from time to time appoint one or more directors, provided that the total number of
directors so appointed does not exceed one-third of the number of directors elected at the last annual meeting of shareholders. Each
elected director will remain in office until termination of the next annual meeting of the shareholders or until his or her successor
is duly elected or appointed, unless his or her post is vacated earlier. We do not have service agreements with our independent directors.
See
Item 6A. for information about the period of service of each of our directors and senior corporate officers.
Standing
Committees of the Board of Directors
Our
Board has established an Audit Committee and a NGCC.
Audit
Committee
The
Audit Committee assists the Board in fulfilling its oversight responsibilities. The Audit Committee reviews the financial reporting process,
the system of internal control, the audit process, and our process for monitoring compliance with laws and regulations and with our Code
of Ethical Conduct. In performing its duties, the Audit Committee will maintain effective working relationships with the Board, management,
and the external auditors. To effectively perform his or her role, each committee member will obtain an understanding of the detailed
responsibilities of committee membership as well as our business, operations and risks.
The
function of the Audit Committee is oversight and while it has the responsibilities and powers set forth in its charter (incorporated
by reference to Exhibit 11.3 to this Annual Report on Form 20-F), it is neither the duty of the committee to plan or to conduct audits
or to determine that our financial statements are complete, accurate and in accordance with generally accepted accounting principles,
nor to maintain internal controls and procedures.
The
current members of the Audit Committee are Dennis Turpin (Chair), Peter G. Edwards, and Gilles Gagnon.
NGCC
The
compensation of executive officers of the Corporation and its subsidiaries is recommended to the Board by the NGCC. The NGCC is responsible
for, among other matters, (i) assisting the Board in developing our approach to corporate governance issues, (ii) proposing new Board
nominees, (iii) overseeing the assessment of the effectiveness of the Board and its committees, their respective chairs and individual
directors and (iv) making recommendations to the Board with respect to board member nominees and directors’ compensation, as well
as serving in a leadership role for our corporate governance practices. It is also responsible for taking all reasonable actions to ensure
that appropriate human resources policies, procedures and systems, e.g., recruitment and retention policies, competency and performance
metrics and measurements, training and development programs, and market-based, competitive compensation and benefits structures, are
in place so that we can attract, motivate and retain the quality of personnel required to achieve our business objectives. The NGCC also
assists the Board in discharging its responsibilities relating to the recruitment, retention, development, assessment, compensation and
succession planning for our executive and senior management members.
Thus,
the NGCC recommends the appointment of senior officers, including the terms and conditions of their appointment and termination, and
reviews the evaluation of the performance of our senior officers, including recommending their compensation and overseeing risk identification
and management in relation to executive compensation policies and practices. The Board, which includes the members of the NGCC, reviews
the Chief Executive Officer’s corporate strategy, goals and performance objectives and evaluates and measures his or her performance
and compensation against the achievement of such goals and objectives.
The
NGCC recognizes that the industry, regulatory and competitive environment in which we operate requires a balanced level of risk-taking
to promote and achieve the performance expectations of executives of a specialty biopharmaceutical company. The NGCC is of the view that
our executive compensation program should not encourage senior executives to take inappropriate or unreasonable risk. In this regard,
the NGCC recommends the implementation of compensation methods that appropriately connect a portion of senior executive compensation
with our short-term and longer-term performance, as well as that of each individual executive officer and that take into account the
advantages and risks associated with such compensation methods. The NGCC is also responsible for establishing compensation policies that
are intended to reward the creation of shareholder value while reflecting a balance between our short-term and longer-term performance
and that of each executive officer.
The
NGCC is currently composed of Ms. Carolyn Egbert (Chair), Mr. Peter G. Edwards and Mr. Gilles Gagnon, each of whom is independent. The
Board believes that the members of the NGCC collectively have the knowledge, experience and background required to fulfill its mandate:
As
at December 31, 2021, we had a total of 17 active employees, of which 16 are based in Frankfurt, Germany. In addition, there was one
employee based in the U.S. and our CFO was based in Toronto, Canada.
Our
current employees are engaged in the following activities: (i) six are engaged in research and development, regulatory affairs and quality
assurance; (ii) five are involved in commercial operations and business development; and (iii) six are involved in various administrative
functions, including finance and accounting. We do not employ any sales representatives. As at December 31, 2020, we had a total of 11
active employees, of which 10 were based in Frankfurt, Germany. In addition, there was one employee based in the U.S. and our CFO was
based in Toronto, Canada.
We
have agreements with our employees covering confidentiality, loyalty, non-competition and assignment of all intellectual property rights
developed during the employment period.
The
table below sets forth information as of March 15, 2022 provided to us by our current directors and named executive officers concerning
their ownership of Common Shares and stock options of the Company:
Name | |
No.
of Common Shares owned or held | | |
Percent(1) | | |
No.
of stock options held(2) | | |
No.
of currently exercisable options | |
Ammer, Nicola | |
| — | | |
| — | | |
| 110,000 | | |
| 35,001 | |
Egbert, Carolyn | |
| 31,920 | | |
| * | | |
| 77,850 | | |
| 77,850 | |
Edwards, Peter G. | |
| — | | |
| — | | |
| — | | |
| — | |
Gagnon, Gilles | |
| — | | |
| — | | |
| — | | |
| — | |
Gerlach, Matthias | |
| — | | |
| — | | |
| 115,000 | | |
| 41,668 | |
Guenther, Eckhard | |
| — | | |
| — | | |
| 115,398 | | |
| 40,399 | |
Paulini, Klaus | |
| 55,000 | | |
| * | | |
| 197,500 | | |
| 54,168 | |
Turpin, Dennis(3) | |
| 32,000 | | |
| — | | |
| — | | |
| — | |
Total | |
| 118,920 | | |
| * | | |
| 620,350 | | |
| 249,086 | |
*
Less than 1%
(1) |
Based
on 121,397,007 Common Shares outstanding as at March 25, 2022. |
(2) |
For
information regarding option expiration dates and exercise price refer to the tables included under the caption “Outstanding
Option-Based Awards and Share-Based Awards”. |
(3) |
Mr.
Turpin joined the Board on May 5, 2021. |
Item
7. |
Major
Shareholders and Related Party Transactions |
We
are not directly or indirectly owned or controlled by another corporation or by any foreign government. Based on filings with the SEC
and the Canadian securities regulatory authorities, as at March 25, 2022, no individual or entity, other than as set out below,
beneficially owned, directly or indirectly, or exercised control or direction over our Common Shares carrying more than 5% of the voting
rights attached to all our Common Shares (to whom we refer as our major shareholders).
Changes
in Percentage Ownership by Major Shareholders
We
had no major shareholders in 2017. During 2018, J. Goldman & Co., L.P. J., Goldman Capital Management, Inc., and Jay G. Goldman (collectively,
“Goldman”) became major shareholders due to the acquisition of over 5% of our outstanding Common Shares, and as of December
31, 2019, Goldman ceased to be the beneficial owner of more than 5% of our Common Shares, based solely on a Schedule 13G filed with the
SEC on February 14, 2020. On February 18, 2020, Armistice Capital Master Fund, LTD became a major shareholder of the Company due to the
acquisition of over 5% of our outstanding Common Shares, but as of December 31, 2020 ceased to beneficially own more than 5% of our Common
Shares, based solely on a Schedule 13G filed with the SEC on February 16, 2021. On July 1, 2020, Intracoastal Capital LLC became a major
shareholder due to the acquisition of over 5% of our outstanding Common Shares, but as of December 31, 2021 ceased to beneficially own
more than 5% of our Common Shares, based solely on a Schedule 13G filed with the SEC on February 11, 2022. On July 2, 2020, Lind Global
Macro Fund, LP became a major shareholder due to the acquisition of over 5% of our outstanding Common Shares, but as of December 31,
2021 ceased to beneficially own more than 5% of our Common Shares, based solely on a Schedule 13G filed with the SEC on February 11,
2022.
United
States Shareholders
Based
on a review of the information provide to us by our transfer agent, as at March 21, 2022, there were 14 holders of record of our
Common Shares, of which two were registered with an address in the U.S., holding in the aggregate approximately 99% of our outstanding
Common Shares. We believe that the number of beneficial owners of our Common Shares is substantially greater than the number of record
holders, because the overwhelming majority of our Common Shares are held in broker “street names”.
B. |
Related
party transactions |
Other
than employment agreements and indemnification agreements with our management, there are no related party transactions.
C. |
Interests
of experts and counsel |
Not
required.
Item
8. |
Financial
Information |
A. |
Consolidated
statements and other financial information |
The
consolidated financial statements filed as part of this Annual Report on Form 20-F are presented under “Item 17. –
Financial Statements”.
No
significant changes occurred since the date of our annual consolidated financial statements included elsewhere in this Annual Report
on Form 20-F.
Item
9. |
The
Offer and Listing |
A. |
Offer
and listing details |
Not
applicable, except for Item 9A(4). Our Common Shares are listed on both the NASDAQ and the TSX under the symbol “AEZS”. The
following table indicates, for the relevant periods, the high and low closing prices of our Common Shares on the NASDAQ and on the TSX
as of December 31, 2021:
| |
NASDAQ
(US$) | | |
TSX
(CAN$) | |
| |
High | | |
Low | | |
High | | |
Low | |
2019 | |
| 5.43 | | |
| 0.77 | | |
| 7.26 | | |
| 1.02 | |
2020 | |
| 1.44 | | |
| 0.30 | | |
| 1.87 | | |
| 0.39 | |
2021 | |
| 3.34 | | |
| 0.36 | | |
| 4.25 | | |
| 0.64 | |
Fourth quarter | |
| 0.77 | | |
| 0.36 | | |
| 0.96 | | |
| 0.455 | |
Third quarter | |
| 0.88 | | |
| 0.59 | | |
| 1.10 | | |
| 0.76 | |
Second quarter | |
| 1.14 | | |
| 0.83 | | |
| 1.42 | | |
| 1.02 | |
First quarter | |
| 3.34 | | |
| 0.51 | | |
| 4.25 | | |
| 0.64 | |
2020 | |
| | | |
| | | |
| | | |
| | |
Fourth quarter | |
| 0.44 | | |
| 0.30 | | |
| 0.56 | | |
| 0.39 | |
Third quarter | |
| 0.55 | | |
| 0.34 | | |
| 0.73 | | |
| 0.46 | |
Second quarter | |
| 1.17 | | |
| 0.45 | | |
| 1.71 | | |
| 0.66 | |
First quarter | |
| 1.44 | | |
| 0.42 | | |
| 1.87 | | |
| 0.59 | |
2019 | |
| | | |
| | | |
| | | |
| | |
Fourth quarter | |
| 1.08 | | |
| 0.77 | | |
| 1.45 | | |
| 1.02 | |
Third quarter | |
| 2.97 | | |
| 1.00 | | |
| 3.86 | | |
| 1.33 | |
Second quarter | |
| 5.43 | | |
| 2.04 | | |
| 7.26 | | |
| 2.73 | |
First quarter | |
| 4.65 | | |
| 3.03 | | |
| 6.25 | | |
| 4.12 | |
Not
applicable.
Our
Common Shares are listed and posted for trading on both the NASDAQ and the TSX under the symbol “AEZS”.
Not
applicable.
Not
applicable.
Not
applicable.
Item
10. |
Additional
Information |
Not
required.
B. |
Memorandum
and articles of association |
We
are governed by our restated articles of incorporation (the “Restated Articles of Incorporation”) under the CBCA and
by articles of amendment dated October 2, 2012, November 17, 2015, and May 9, 2019 (together with the Restated Articles of Incorporation,
the “Articles”) and by our bylaws, as amended and restated on March 21, 2013 (the “bylaws”). Our
Articles are on file with Corporations Canada under Corporation Number 264271-9. The Articles do not include a stated purpose and do
not place any restrictions on the business that we may carry on.
Inspection
Rights of Shareholders
Under
the CBCA, shareholders are entitled to be provided with a copy of the list of our registered shareholders. In order to obtain the shareholder
list, a shareholder must provide to us an affidavit including, among other things, a statement that the list will only be used for the
purposes permitted by the CBCA. These permitted purposes include an effort to influence the voting of our shareholders, an offer to acquire
our securities and any other matter relating to our affairs. We are entitled to charge a reasonable fee for the provision of the shareholder
list and must deliver that list no more than ten days after receipt of the affidavit described above.
Under
the CBCA, shareholders have the right to inspect certain corporate records, including our Articles and bylaws and minutes of meetings
and resolutions of the shareholders. Shareholders have no statutory right to inspect minutes of meetings and resolutions of our directors.
Our shareholders have the right to certain financial information respecting us. In addition to the annual and quarterly financial statements
required to be filed under applicable securities laws, we are required by the CBCA to place before every annual meeting of shareholders
our audited comparative annual financial statements. In addition, shareholders have the right to examine the financial statements of
each of our subsidiaries and any other corporate entity whose accounts are consolidated in our financial statements.
Directors
The
minimum number of directors we must have is five (5) and the maximum number is fifteen (15). In accordance with the CBCA, at least 25%
of our directors must be residents of Canada. In order to serve as a director, a person must be a natural person at least 18 years of
age, of sound mind, not bankrupt, and must not be prohibited by any court from holding the office of director. None of the Articles,
the bylaws and the CBCA impose any mandatory retirement requirements for directors.
The
directors are elected by a majority of the votes cast at the annual meeting at which an election of directors is required, to hold office
until the election of their successors, except in the case of resignations or if their offices become vacant by death or otherwise. Subject
to the provisions of our bylaws, all directors may, if still qualified to serve as directors, stand for re-election. The Board is not
replaced at staggered intervals but is elected annually.
There
is no provision in our bylaws or Articles that requires that a director must be a shareholder.
The
directors are entitled to remuneration as shall from time to time be determined by the Board or by a committee to which the Board may
delegate the power to do so. Under the mandate of the NGCC, such committee, comprised of at least a majority of independent directors,
is tasked with making recommendations to the Board concerning director remuneration.
The
CBCA provides that a director who is a party to, or who is a director or officer of, or has a material interest in, any person who is
a party to a material contract or transaction or proposed material contract or transaction with us must disclose to us the nature and
extent of his or her interest at the time and in the manner provided by the CBCA, or request that same be entered in the minutes of the
meetings of the Board, even if such contract, in connection with our normal business activity, does not require the approval of either
the directors or the shareholders. At the request of the president or any director, the director placed in a situation of conflict of
interest must leave the meeting while the Board discusses the matter. The CBCA prohibits such a director from voting on any resolution
to approve the contract or transaction unless the contract or transaction:
● |
relates
primarily to his or her remuneration as our director, officer, employee or agent or as a director, officer, employee or agent of
an affiliate of us; |
|
|
● |
is
for indemnity or insurance for director’s liability as permitted by the CBCA; or |
|
|
● |
is
with our affiliate. |
The
CBCA provides that the Board may, on our behalf and without authorization of our shareholders:
● |
borrow
money upon our credit; |
|
|
● |
issue,
reissue, sell or pledge our debt obligations; |
|
|
● |
give
a guarantee on our behalf to secure performance of an obligation of any person; and |
|
|
● |
mortgage,
hypothecate, pledge or otherwise create a security interest in all or any of our property, owned or subsequently acquired, to secure
any of our obligations. |
The
shareholders have the ability to restrict such powers through our Articles or bylaws (or through a unanimous shareholder agreement),
but no such restrictions are in place.
The
CBCA prohibits the giving of a guarantee to any of our shareholders, directors, officers or employees or of an affiliated corporation
or to an associate of any such person for any purpose or to any person for the purpose of or in connection with a purchase of a share
issued or to be issued by us or our affiliates, where there are reasonable grounds for believing that we are or, after giving the guarantee,
would be unable to pay our liabilities as they become due, or the realizable value of our assets in the form of assets pledged or encumbered
to secure a guarantee, after giving the guarantee, would be less than the aggregate of our liabilities and stated capital of all classes.
These borrowing powers may be varied by our bylaws or Articles. However, our bylaws and Articles do not contain any restrictions on or
variations of these borrowing powers.
Pursuant
to the CBCA, our directors manage and administer our business and affairs and exercise all such powers and authority as we are authorized
to exercise pursuant to the CBCA, the Articles and the bylaws. The general duties of our directors and officers under the CBCA are to
act honestly and in good faith with a view to our best interests and to exercise the care, diligence and skill that a reasonably prudent
person would exercise in comparable circumstances. Any breach of these duties may lead to liability to us and our shareholders for breach
of fiduciary duty. In addition, a breach of certain provisions of the CBCA, including the improper payment of dividends or the improper
purchase or redemption of shares, will render the directors who authorized such action liable to account to us for any amounts improperly
paid or distributed.
Our
bylaws provide that the Board may, from time to time, appoint from amongst their number committees of the Board, and delegate to any
such committee any of the powers of the Board except those which pursuant to the CBCA a committee of the Board has no authority to exercise.
As such, the Board has two standing committees: the Audit Committee and the Nominating, Governance and Compensation Committee, or the
NGCC.
Subject
to the limitations provided by the CBCA, our bylaws provide that we shall, to the full extent provided by law, indemnify a director or
an officer, a former director or officer or a person who acts or acted at our request as a director or officer of a body corporate of
which we are or were a shareholder or creditor, and his or her heirs and legal representatives, against all costs, losses, charges and
expenses, including an amount paid to settle an action or satisfy a judgment, reasonably incurred by him or her in respect of any civil,
criminal or administrative action or proceeding to which he or she is made a party by reason of having been our director or officer or
such body corporate, provided: (a) he or she acted in good faith in our best interests and (b) in the case of a criminal or an administrative
action or proceeding that is enforced by a monetary penalty, he or she had reasonable grounds to believe that his or her conduct was
lawful.
Our
directors are authorized to indemnify from time to time any director or other person who has assumed or is about to assume in the normal
course of business any liability for us or for any corporation controlled by us and to secure such director or other person against any
loss by the pledge of all or part of our movable or immovable property through the creation of a hypothec or any other real right in
all or part of such property or in any other manner.
We
have also agreed to indemnify and save harmless our directors and senior corporate officers as well as the managing directors of our
German subsidiary pursuant to various Director and Officer Indemnification Agreements against certain charges, damages, awards, settlements,
liabilities, interest, judgments, fines, penalties, statutory obligations, professional fees and retainers and other expenses of whatever
nature or kind, provided that any such costs, charges, professional fees and other expenses are reasonable (collectively, “Expenses”)
and from and against all Expenses sustained or incurred by the indemnified party as a result of serving as a director, officer or employee
of the Company (or its subsidiary) in respect of any act, matter, deed or thing whatsoever made, done, committed, permitted, omitted
or acquiesced in by the indemnified party as a director, officer or employee of the Company (or its subsidiary).
Share
Capitalization
Our
authorized share capital structure consists of an unlimited number of shares of the following classes (all classes are without nominal
or par value): Common Shares; and first preferred shares (the “First Preferred Shares”) and second preferred shares
(the “Second Preferred Shares” and, together with the First Preferred Shares, the “Preferred Shares”),
both issuable in series. As at March 25, 2022, there were approximately 121,397,007
Common Shares outstanding. No Preferred Shares have been issued to date. We have also issued warrants to acquire Common Shares in connection
with certain equity financings.
Common
Shares
The
holders of the Common Shares are entitled to one vote for each Common Share held by them at all meetings of shareholders, except meetings
at which only shareholders of a specified class of shares are entitled to vote. In addition, the holders are entitled to receive dividends
if, as and when declared by our Board on the Common Shares. Finally, the holders of the Common Shares are entitled to receive our remaining
property upon any liquidation, dissolution or winding-up of our affairs, whether voluntary or involuntary. Shareholders have no liability
to further capital calls as all shares issued and outstanding are fully paid and non-assessable.
Preferred
Shares
The
First and Second Preferred Shares are issuable in series with rights and privileges specific to each class. The holders of Preferred
Shares are generally not entitled to receive notice of or to attend or vote at meetings of shareholders. The holders of First Preferred
Shares are entitled to preference and priority to any participation of holders of Second Preferred Shares, Common Shares or shares of
any other class of shares of our share capital ranking junior to the First Preferred Shares with respect to dividends and, in the event
of our liquidation, the distribution of our property upon our dissolution or winding-up, or the distribution of all or part of our assets
among the shareholders, to an amount equal to the value of the consideration paid in respect of such shares outstanding, as credited
to our issued and paid-up share capital, on an equal basis, in proportion to the amount of their respective claims in regard to such
shares held by them. The holders of Second Preferred Shares are entitled to preference and priority to any participation of holders of
Common Shares or shares of any other class of shares of our share capital ranking junior to the Second Preferred Shares with respect
to dividends and, in the event of our liquidation, the distribution of our property upon our dissolution or winding-up, or the distribution
of all or part of our assets among the shareholders, to an amount equal to the value of the consideration paid in respect of such shares
outstanding, as credited to our issued and paid-up share capital, on an equal basis, in proportion to the amount of their respective
claims in regard to such shares held by them.
Our
Board may, from time to time, provide for additional series of Preferred Shares to be created and issued, but the issuance of any Preferred
Shares is subject to the general duties of the directors under the CBCA to act honestly and in good faith with a view to our best interests
and to exercise the care, diligence and skill that a reasonably prudent person would exercise in comparable circumstances.
Warrants
For
a description of our Warrants, see note 19 – share capital, warrants and other capital, to
the audited consolidated financial statements included in Item 17 of this Annual Report on Form 20-F.
Shareholder
Actions
The
CBCA provides that our shareholders may, with leave of a court, bring an action in our name and on our behalf for the purpose of prosecuting,
defending or discontinuing an action on our behalf. In order to grant leave to permit such an action, the CBCA provides that the court
must be satisfied that our directors were given adequate notice of the application, the shareholder is acting in good faith and that
it appears to be in our best interests that the action be brought.
Shareholder
Rights Plan
The
Board of the Company approved an amended and restated shareholder rights plan of the Company on March 29, 2019, which was approved, ratified
and confirmed by the shareholders at the annual and special meeting of shareholders of the Company on May 8, 2019 (the “Rights
Plan”). The Rights Plan amended and restated the Company’s shareholder rights plan originally implemented in 2016 and
was implemented to ensure, to the extent possible, that all shareholders of the Company are treated fairly in connection with any take-over
offer or other acquisition of control of the Company.
Objectives
and Background of the Rights Plan
The
fundamental objectives of the Rights Plan are to provide adequate time for our Board and shareholders to assess an unsolicited take-over
bid for us, to provide the Board with sufficient time to explore and develop alternatives for maximizing shareholder value if a take-over
bid is made, and to provide shareholders with an equal opportunity to participate in a take-over bid.
The
Rights Plan encourages a potential acquiror who makes a take-over bid to proceed either by way of a “Permitted Bid”, as described
below, which requires a take-over bid to satisfy certain minimum standards designed to promote fairness, or with the concurrence of our
Board. If a take-over bid fails to meet these minimum standards and the Rights Plan is not waived by the Board, the Rights Plan provides
that holders of Common Shares, other than the acquiror, will be able to purchase additional Common Shares at a significant discount to
market, thus exposing the person acquiring Common Shares to substantial dilution of its holdings.
Summary
of the Rights Plan
The
following is a summary of the principal terms of the Rights Plan, which summary is qualified in its entirety by reference to the terms
thereof. Capitalized terms not otherwise defined in this summary shall have the meaning ascribed to such terms in the Rights Plan. A
draft of the Rights Plan is available at the following websites: www.zenataris.com, www.sedar.com and www.sec.gov.
For
the purposes of this summary and as set out in the Rights Plan, the term “NI 62-104” refers to National Instrument 62-104-Take-Over
Bids and Issuer Bids adopted by the Canadian securities regulatory authorities, as now in effect or as the same may from time to
time be amended, re-enacted or replaced and including for greater certainty any successor instrument thereto.
Operation
of the Rights Plan
Pursuant
to the terms of the Rights Plan, one right was issued in respect of each common share outstanding at 5:01 p.m. on March 29, 2016 (the
“Record Time”). In addition, we will issue one right for each additional Common Share issued after the Record Time
and prior to the earlier of the Separation Time (as defined below) and the Expiration Time (as defined below). The rights have an initial
exercise price equal to the Market Price (as defined below) of the Common Shares as determined at the Separation Time, multiplied by
five, subject to certain anti-dilution adjustments (the “Exercise Price”), and they are not exercisable until the
Separation Time. Upon the occurrence of a Flip-in Event (as defined below), each right will entitle the holder thereof, other than an
Acquiring Person or any other person whose rights are or become void pursuant to the provisions of the Rights Plan, to purchase from
us, effective at the close of business on the eighth trading day after the Stock Acquisition Date (as defined below), upon payment to
us of the Exercise Price, Common Shares having an aggregate Market Price equal to twice the Exercise Price on the date of consummation
or occurrence of such Flip-in Event, subject to certain anti-dilution adjustments.
Definition
of Market Price
Market
Price is generally defined in the Rights Plan, on any given day on which a determination must be made, as the volume weighted average
trading price of the Common Shares for the 20 consecutive trading days (i.e. days on which the TSX or another stock exchange or national
securities quotation system on which the Common Shares are traded (including for greater certainty, each of the Nasdaq Global Select
Market, the Nasdaq Global Market and the Nasdaq Capital Market) is open for the transaction of business, subject to certain exceptions),
through and including the trading day immediately preceding such date of determination, subject to certain exceptions.
Trading
of Rights
Until
the Separation Time (or the earlier termination or expiration of the rights), the rights trade together with the Common Shares and are
represented by the same share certificates as the Common Shares or an entry in our securities register in respect of any outstanding
Common Shares. From and after the Separation Time and prior to the Expiration Time, the rights are evidenced by rights certificates and
trade separately from the Common Shares. The rights do not carry any of the rights attaching to the Common Shares such as voting or dividend
rights.
Separation
Time
The
rights will separate from the Common Shares to which they are attached and become exercisable at the time (the “Separation Time”)
of the close of business on the eighth business day after the earliest to occur of:
1. |
the
first date (the “Stock Acquisition Date”) of a public announcement of facts indicating that a person has become
an Acquiring Person; and |
|
|
2. |
the
date of the commencement of, or first public announcement of the intention of any person (other than us or any of our subsidiaries)
to commence a take-over bid or a share exchange bid for more than 20% of our outstanding Common Shares other than a Permitted Bid
or a Competing Permitted Bid (as defined below), so long as such take-over bid continues to satisfy the requirements of a Permitted
Bid or a Competing Permitted Bid, as the case may be. |
The
Separation Time can also be such later time as may from time to time be determined by the Board, provided that if any such take-over
bid expires, or is canceled, terminated or otherwise withdrawn prior to the Separation Time, without securities deposited thereunder
being taken up and paid for, it shall be deemed never to have been made and if the Board determines to waive the application of the Rights
Plan to a particular Flip-in Event, the Separation Time in respect of such Flip-in Event shall be deemed never to have occurred.
From
and after the Separation Time and prior to the Expiration Time, each right entitles the holder thereof to purchase one Common Share upon
payment of the Exercise Price to us.
Flip-in
Event
The
acquisition by a person (an “Acquiring Person”), including others acting jointly or in concert with such person, of
more than 20% of the outstanding Common Shares, other than by way of a Permitted Bid, a Competing Permitted Bid or in certain other limited
circumstances described in the Rights Plan, is referred to as a “Flip-in Event”.
In
the event that, prior to the Expiration Time, a Flip-in Event that has not been waived occurs (see “Waiver and Redemption”
below), each right (other than those held by or deemed to be held by the Acquiring Person) will thereafter entitle the holder thereof,
effective as at the close of business on the eighth trading day after the Stock Acquisition Date, to purchase from us, upon payment of
the Exercise Price and otherwise exercising such right in accordance with the terms of the Rights Plan, that number of Common Shares
having an aggregate Market Price on the date of consummation or occurrence of the Flip-in Event equal to twice the Exercise Price, for
an amount in cash equal to the Exercise Price (subject to certain anti-dilution adjustments described in the Rights Plan).
A
bidder may enter into Permitted Lock-up Agreements with our shareholders (“Locked-up Persons”) who are not affiliates
or associates of the bidder and who are not, other than by virtue of entering into such agreement, acting jointly or in concert with
the bidder, whereby such shareholders agree to tender their Common Shares to the take-over bid (the “Lock-up Bid”)
without the bidder being deemed to beneficially own the Common Shares deposited pursuant to the Lock-up Bid. Any such agreement must
include a provision that permits the Locked-up Person to withdraw the Common Shares to tender to another take-over bid or to support
another transaction that will either provide greater consideration to the shareholder than the Lock-up Bid or provide for a right to
sell a greater number of shares than the Lock-up Bid contemplates (provided that the Permitted Lock-up Agreement may require that such
greater number exceed the number of shares under the Locked-up Bid by a specified percentage not to exceed 7%).
A
Permitted Lock-up Agreement may require that the consideration under the other transaction exceed the consideration under the Lock-up
Bid by a specified amount. The specified amount may not be greater than 7%. For greater certainty, a Permitted Lock-up Agreement may
contain a right of first refusal or require a period of delay (or other similar limitation) to give a bidder an opportunity to match
a higher price in another transaction as long as the limitation does not preclude the exercise by the Locked-up Person of the right to
withdraw the Common Shares during the period of the other take-over bid or transaction.
The
Rights Plan requires that any Permitted Lock-up Agreement be made available to us and the public. The definition of Permitted Lock-up
Agreement also provides that under a Permitted Lock-up Agreement, no “break up” fees, “topping” fees, penalties,
expenses or other amounts that exceed in aggregate the greater of (i) 2.5% of the price or value of the aggregate consideration payable
under the Lock-up Bid, and (ii) 50% of the amount by which the price or value of the consideration received by a Locked-up Person under
another take-over bid or transaction exceeds what such Locked-up Person would have received under the Lock-up Bid, can be payable by
such Locked-up Person if the Locked-up Person fails to deposit or tender Common Shares to the Lock-up Bid or withdraws Common Shares
previously tendered thereto in order to deposit such Common Shares to another take-over bid or support another transaction.
Permitted
Bid Requirements
The
requirements of a Permitted Bid include the following:
1. |
the
take-over bid must be made by means of a take-over bid circular; |
|
|
2. |
the
take-over bid must be made to all holders of Common Shares wherever resident, on identical terms and conditions, other than the bidder;
|
|
|
3. |
the
take-over bid must not permit Common Shares tendered pursuant to the bid to be taken up or paid for: |
|
a) |
prior
to the close of business on a date that is not less than 105 days following the date of the relevant take-over bid or such shorter
minimum period that a take-over bid (that is not exempt from any of the requirements of Division 5 (Bid Mechanics of NI 62-104))
must remain open for deposits of securities thereunder, in the applicable circumstances at such time, pursuant to NI 62-104; |
|
|
|
|
b) |
then
only if at the close of business on the date Common Shares (and/or “Convertible Securities”, as defined in the Rights
Plan) are first taken up or paid for under such take-over bid, outstanding Common Shares and Convertible Securities held by shareholders
other than any other Acquiring Person, the bidder, the bidder’s affiliates or associates, persons acting jointly or in concert
with the bidder and any employee benefit plan, deferred profit-sharing plan, stock participation plan or trust for the benefit of
our employees or the employees of any of our subsidiaries, unless the beneficiaries of such plan or trust direct the manner in which
the Common Shares are to be voted or direct whether the Common Shares are to be tendered to a take-over bid (collectively, “Independent
Shareholders”) that represent more than 50% of the aggregate of (I) then outstanding Common Shares and (II) Common Shares
issuable upon the exercise of Convertible Securities, have been deposited or tendered pursuant to the take-over bid and not withdrawn;
|
4. |
the
take-over bid must allow Common Shares and/or Convertible Securities to be deposited or tendered pursuant to such take-over bid,
unless such take-over bid is withdrawn, at any time prior to the close of business on the date Common Shares and/or Convertible Securities
are first taken up or paid for under the take-over bid; |
|
|
5. |
the
take-over bid must allow Common Shares and/or Convertible Securities to be withdrawn until taken up and paid for; and |
|
|
6. |
in
the event the requirement set forth in clause 3.b) above is satisfied, the bidder must make a public announcement of that fact and
the take-over bid must remain open for deposits and tenders of Common Shares for not less than ten days from the date of such public
announcement. |
A
Permitted Bid need not be a bid for all outstanding Common Shares not held by the bidder, i.e., a Permitted Bid may be a partial bid.
The Rights Plan also allows a competing Permitted Bid (a “Competing Permitted Bid”) to be made while a Permitted Bid
is in existence. A Competing Permitted Bid must satisfy all the requirements of a Permitted Bid other than the requirement set out in
clause 3.a) above and must not permit Common Shares tendered or deposited pursuant to the bid to be taken up or paid for prior to the
close of business on the last day of the minimum initial deposit period that such take-over bid must remain open for deposits of securities
thereunder pursuant to NI 62-104 after the date of the take-over bid constituting the Competing Permitted Bid; provided, however, that
a take-over bid that has qualified as a Competing Permitted Bid shall cease to be a Competing Permitted Bid at any time and as soon as
such time as when such take-over bid ceases to meet any or all of the foregoing provisions of the definition of “Competing Permitted
Bid” and any acquisition of Common Shares and/or Convertible Securities made pursuant to such take-over bid that qualified as a
Competing Permitted Bid, including any acquisition of Common Shares and/or Convertible Securities made before such take-over bid ceased
to be a Competing Permitted Bid, will not be a “Permitted Bid Acquisition” (as defined in the Rights Plan).
Waiver
and Redemption
The
Board may, prior to the occurrence of a Flip-in Event, waive the dilutive effects of the Rights Plan in respect of, among other things,
a particular Flip-in Event resulting from a take-over bid made by way of a take-over bid circular to all holders of our Common Shares.
In such an event, such waiver shall also be deemed to be a waiver in respect of any other Flip-in Event occurring under a take-over bid
made by way of a take-over bid circular to all holders of Common Shares prior to the expiry of the first mentioned take-over bid.
The
Board may, with the approval of a majority of Independent Shareholders (or, after the Separation Time has occurred, holders of rights,
other than rights which are void pursuant to the provisions of the Rights Plan or which, prior to the Separation Time, are held otherwise
than by Independent Shareholders), at any time prior to the occurrence of a Flip-in Event which has not been waived, elect to redeem
all, but not less than all, of the then outstanding rights at a price of CAN$0.00001 each, appropriately adjusted as provided in the
Rights Plan (the “Redemption Price”).
Where
a take-over bid that is not a Permitted Bid or Competing Permitted Bid is withdrawn or otherwise terminated after the Separation Time
has occurred and prior to the occurrence of a Flip-in Event, the Board may elect to redeem all the outstanding rights at the Redemption
Price without the consent of the holders of the Common Shares or the rights and reissue rights under the Rights Plan to holders of record
of Common Shares immediately following such redemption. Upon the rights being so redeemed and reissued, all the provisions of the Rights
Plan will continue to apply as if the Separation Time had not occurred, and the Separation Time will be deemed not to have occurred and
we shall be deemed to have issued replacement rights to the holders of its then outstanding Common Shares.
Amendment
to the Rights Plan
The
Rights Plan may be amended to correct any clerical or typographical error or to make such changes as are required to maintain the validity
of the Rights Plan as a result of any change in any applicable legislation, regulations or rules thereunder, without the approval of
the holders of the Common Shares or rights. Prior to the Separation Time, we may, with the prior consent of the holders of Common Shares,
amend, vary or delete any of the provisions of the Rights Plan in order to effect any changes which the Board, acting in good faith,
considers necessary or desirable. We may, with the prior consent of the holders of rights, at any time after the Separation Time and
before the Expiration Time, amend, vary or delete any of the provisions of the Rights Plan.
Protection
Against Dilution
The
Exercise Price, the number and nature of securities which may be purchased upon the exercise of rights and the number of rights outstanding
are subject to adjustment from time to time to prevent dilution in the event of stock dividends, subdivisions, consolidations, reclassifications
or other changes in the outstanding Common Shares, pro rata distributions to holders of Common Shares and other circumstances where adjustments
are required to appropriately protect the interests of the holders of rights.
Fiduciary
Duty of Board
The
Rights Plan will not detract from or lessen the duty of the Board to act honestly and in good faith with a view to our best interests
and the best interests of our shareholders. The Board will continue to have the duty and power to take such actions and make such recommendations
to our shareholders as are considered appropriate.
Exemptions
for Investment Advisors
Fund
managers, investment advisors (for fully-managed accounts), trust companies (acting in their capacities as trustees and administrators),
statutory bodies whose business includes the management of funds, and administrators of registered pension plans are exempt from triggering
a Flip-in Event, provided that they are not making, or are not part of a group making, a take-over bid.
Term
The
Rights Plan will expire on the earlier of (i) the Termination Time; and (ii) the Close of Business on the date on which the annual meeting
of the Company to be held in 2022 and at every third annual meeting of the Company thereafter (each such annual meeting being a “Reconfirmation
Meeting”) occurs and at which the Rights Plan is not reconfirmed or presented for reconfirmation as contemplated in the Rights
Plan (the “Expiration Time”).
Action
Necessary to Change Rights of Shareholders
In
order to change the rights of our shareholders, we would need to amend our Articles to effect the change. Such an amendment would require
the approval of holders of two-thirds of the issued and outstanding shares cast at a duly called special meeting. For certain amendments,
a shareholder is entitled under the CBCA to dissent in respect of such a resolution amending the Articles and, if the resolution is adopted
and we implement such changes, demand payment of the fair value of its shares.
Disclosure
of Share Ownership
In
general, under applicable securities regulation in Canada, a person or company who beneficially owns, or who directly or indirectly exercises
control or direction over voting securities of a reporting issuer, voting securities of an issuer or a combination of both, carrying
more than ten percent of the voting rights attached to all the issuer’s outstanding voting securities is an insider and must, within
ten days of becoming an insider, file a report in the required form effective the date on which the person became an insider, disclosing
any direct or indirect beneficial ownership of, or control or direction over, securities of the reporting issuer.
Additionally,
securities regulation in Canada provides for the filing of a report by an insider of a reporting issuer whose holdings change, which
report must be filed within five days from the day on which the change takes place.
Section
13 of the Exchange Act imposes reporting requirements on persons who acquire beneficial ownership (as such term is defined in the Rule
13d-3 under the Exchange Act) of more than five percent of a class of an equity security registered under Section 12 of the Exchange
Act. Our Common Shares are so registered. In general, such persons must file, within ten days after such acquisition, a report of beneficial
ownership with the SEC containing the information prescribed by the regulations under Section 13 of the Exchange Act. This information
is also required to be sent to the issuer of the securities and to each exchange where the securities are traded.
Meeting
of Shareholders
An
annual meeting of shareholders is held each year for the purpose of considering the financial statements and reports, electing directors,
appointing auditors and fixing or authorizing the Board to fix their remuneration and for the transaction of other business as may properly
come before a meeting of shareholders. Any annual meeting may also constitute a special meeting to take cognizance and dispose of any
matter of which a special meeting may take cognizance and dispose. Under the bylaws, our Chief Executive Officer or our President has
the power to call a meeting of shareholders.
The
CBCA provides that the holders of not less than 5% of our outstanding voting shares may requisition our directors to call a meeting of
shareholders for the purpose stated in the requisition. Except in limited circumstances, including where a meeting of shareholders has
already been called and a notice of meeting already given or where it is clear that the primary purpose of the requisition is to redress
a personal grievance against us or our directors, officers or shareholders, our directors, on receipt of such requisition, must call
a meeting of shareholders. If the directors fail to call a meeting of shareholders within twenty-one days after receiving the requisition,
any shareholder who signed the requisition may call the meeting of shareholders and, unless the shareholders resolve otherwise at the
meeting, we shall reimburse the shareholders for the expenses reasonably incurred by them in requisitioning, calling and holding the
meeting of shareholders.
The
CBCA also provides that, except in limited circumstances, a resolution in writing signed by all of the shareholders entitled to vote
on that resolution at a meeting of shareholders is as valid as if it had been passed at a meeting of shareholders.
A
quorum of shareholders is present at an annual or special meeting of shareholders, regardless of the number of persons present in person
at the meeting, if the holder(s) of shares representing at least 10% of the outstanding voting shares at such meeting are present in
person or represented in accordance with our bylaws. In the case where the CBCA, our Articles or our bylaws require or permit the vote
by class of holders of a given class of shares of our share capital, the quorum at any meeting will be one or more persons representing
10% of the outstanding shares of such class.
Notice
of the time and place of each annual or special meeting of shareholders must be given not less than 21 days, nor more than 50 days, before
the date of each meeting to each director, to the auditor and to each shareholder entitled to vote thereat. If the address of any shareholder,
director or auditor does not appear in our books, the notice may be sent to such address as the person sending the notice may consider
to be most likely to reach such shareholder, director or auditor promptly. Every person who, by operation of the CBCA, transfers or by
any other means whatsoever, becomes entitled to any share, shall be bound by every notice given in respect of such share which, prior
to the entry of his or her name and address on our register, is given to the person whose name appears on the register at the time such
notice is sent. Notice of meeting of shareholders called for any other purpose other than consideration of the financial statements and
auditor’s report, election of directors and reappointment of the incumbent auditor, must state the nature of the business in sufficient
detail to permit the shareholder to form a reasoned judgment on and must state the text of any special resolution or bylaw to be submitted
to the meeting.
Our
bylaws include an advance notice provision (the “Advance Notice Requirement”). The Advance Notice Requirement applies
in certain circumstances where nominations of persons for election to the Board are made by our shareholders other than pursuant to:
(a) a requisition of a meeting made pursuant to the provisions of the CBCA; or (b) a shareholder proposal made pursuant to the provisions
of the CBCA.
Among
other things, the Advance Notice Requirement fixes a deadline by which shareholders must submit a notice of director nominations to us
prior to any annual or special meeting of shareholders where directors are to be elected and sets forth the information that a shareholder
must include in the notice for it to be valid. In the case of an annual meeting of shareholders, we must be given not less than 30 nor
more than 65 days’ notice prior to the date of the annual meeting; provided, however, that in the event that the annual meeting
is to be held on a date that is less than 50 days after the date on which the first public announcement of the date of the annual meeting
was made, notice may be made not later than the close of business on the 10th day following such public announcement. In the
case of a special meeting of shareholders (which is not also an annual meeting), we must be given notice not later than the close of
business on the 15th day following the day on which the first public announcement of the date of the special meeting was made.
The
Board may, in its sole discretion, waive any requirement of the Advance Notice Requirement.
Limitations
on Right to Own Securities
Neither
Canadian law nor our Articles or bylaws limit the right of a non-resident to hold or vote our Common Shares, other than as provided in
the Investment Canada Act (the “Investment Act”).
The
Investment Act requires any person that is a “non-Canadian” (as defined in the Investment Act) who acquires “control”
(as defined in the Investment Act) of an existing Canadian business to file either a pre-closing application for review or a post-closing
notification with Innovation, Science and Economic Development Canada.
As
of February 15, 2020, the threshold for review of a direct acquisition of control of a non-cultural Canadian business by a World Trade
Organization member country investor that is not a state-owned enterprise is an enterprise value of assets that exceeds CAN$1.075 billion.
For “trade agreement investors” that are not state-owned enterprises (as defined in the Investment Act), which as of March
2020 include investors ultimately controlled by nationals of Australia, Chile, Colombia, EU member states, Honduras, Japan, Korea, Mexico,
New Zealand, Panama, Peru, Singapore, the U.S. or Vietnam, the threshold for review of a direct acquisition of control of a non-cultural
Canadian business is an enterprise value of assets that exceeds CAN$1.613 billion. The enterprise value review thresholds for both World
Trade Organization member countries and trade agreement investors are indexed to annual GDP growth and are adjusted accordingly each
year. For purposes of a publicly traded company, the “enterprise value” of the assets of the Canadian business is equal to
the market capitalization of the entity, plus its liabilities (excluding its operating liabilities), minus its cash and cash equivalents.
As
such, under the Investment Act, the acquisition of control of us (either through the acquisition of our Common Shares or all or substantially
all our assets) by a non-Canadian who is a World Trade Organization member country investor or a trade agreement investor, including
a U.S. investor, would be reviewable only if the enterprise value of our assets exceeds the specified threshold for review.
Where
the acquisition of control is a reviewable transaction, the Investment Act generally prohibits the implementation of the reviewable transaction
unless, after review, the relevant Minister is satisfied or deemed to be satisfied that the acquisition is likely to be of net benefit
to Canada.
The
acquisition of a majority of the voting interests of an entity is deemed to be acquisition of “control” of that entity. The
acquisition of less than a majority but one-third or more of the total number of votes attached to all of the voting shares of a corporation
or of an equivalent undivided ownership interest in the total number of votes attached to all of the voting shares of the corporation
is presumed to be an acquisition of control of that corporation unless it can be established that, on the acquisition, the corporation
is not controlled in fact by the acquiror through the ownership of voting shares. The acquisition of less than one-third of the total
number of votes attached to all of the voting shares of a corporation is deemed not to be acquisition of control of that corporation
subject to certain discretionary rights relative to investments involving state-owned enterprises. Other than in connection with a “national
security” review, discussed below, certain transactions in relation to our Common Shares would be exempt from the Investment Act
including:
● |
the
acquisition of our Common Shares by a person in the ordinary course of that person’s business as a trader or dealer in securities; |
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|
● |
the
acquisition or control of us in connection with the realization of security granted for a loan or other financial assistance and
not for any purpose related to the provisions of the Investment Act, if the acquisition is subject to approval under the Bank Act,
the Cooperative Credit Associations Act, the Insurance Companies Act or the Trust and Loan Companies Act; and |
|
|
● |
the
acquisition or control of us by reason of an amalgamation, merger, consolidation or corporate reorganization following which the
ultimate direct or indirect control in fact of us, through the ownership of our voting interests, remains unchanged. |
Under
the national security regime in the Investment Act, review on a discretionary basis may also be undertaken by the federal government
in respect of a much broader range of investments by a non-Canadian to “acquire, in whole or in part, or to establish an entity
carrying on all or any part of its operations in Canada”. The relevant test is whether such an investment by a non-Canadian could
be “injurious to national security”. The Minister of Innovation, Science and Economic Development has broad discretion to
determine whether an investor is a non-Canadian and therefore may be subject to national security review. Review on national security
grounds is at the discretion of the federal government and may occur on a pre- or post-closing basis.
There
is no law, governmental decree or regulation in Canada that restricts the export or import of capital, or which would affect the remittance
of dividends or other payments by us to non-resident holders of our Common Shares, other than withholding tax requirements.
The
following are the only material agreements of the Company that are in effect as of the date hereof (other than certain agreements entered
into in the ordinary course of business):
|
● |
the
United States and Canada License Agreement (as described below); and |
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● |
the
Licensing Agreement with Consilient Health (as described below). |
United
States and Canada License Agreement
On
January 16, 2018, the Company, through AEZS Germany, entered into a License Agreement with Strongbridge, to carry out development, manufacturing,
registration and commercialization of Macrilen™ (macimorelin) in the U.S. and Canada, and received a cash payment of $24 million
(the “2018 Agreement”).
Effective
December 19, 2018, Strongbridge sold its rights to Macrilen™ (macimorelin) in Canada and the U.S. to Novo, and Novo
agreed to fund Strongbridge’ s Macrilen™ (macimorelin) field organization as a contract field force to promote the product
in the U.S. for up to three years. This service agreement was terminated as of December 1, 2019.
On
November 16, 2020, the Company announced that, through a wholly owned subsidiary, it had entered into an amendment (the “Amendment”)
of its existing License Agreement with Novo related to the development and commercialization of macimorelin. Under the terms of
the original License Agreement, Novo was granted the exclusive right to commercialize macimorelin in the U.S. and Canada. Novo
is currently marketing macimorelin in the U.S. under the tradename Macrilen™ for the diagnosis of AGHD. The Amendment was intended
to amend the 2018 Agreement to, among others:
|
● |
Reflect
the updated supply arrangement between the parties relating to the supply of the API Macimorelin acetate; |
|
|
|
|
● |
Grant
Novo a joint ownership interest in the Aeterna Patent Rights and Trademarks; |
|
|
|
|
● |
Amend
responsibility between the Parties for the pediatric clinical trial for the Pediatric Indication (100% cost reimbursement up to EUR
9 million and 50% of exceeding costs per the Amendment, as compared to a total of 70% of costs in the 2018 Agreement); and |
|
|
|
|
● |
Modify
the future payment obligations, i.e. reduction of royalty rate and waiver by the Company of the future regulatory milestone payment
on FDA approval of Pediatric Indication. |
Under
the Amendment, Aeterna continued to retain all rights to macimorelin outside of the U.S. and Canada, but Novo agreed to make an upfront
payment to Aeterna of $6,109 (€5,000), which the Company received in December 2020. Under the Amendment, the royalty payment Aeterna
receives on sales in the U.S. and Canada was reduced from 15% to 8.5% for annual net sales up to U.S.$40 million and returns to 15% or
more for annual net sales of macimorelin over U.S.$40 million. Additionally, the $5 million variable payment owing to Aeterna by Novo,
upon FDA approval of the pediatric indication, was waived. Under the Amendment, Novo and Aeterna agreed that solely Aeterna will conduct
the pivotal Study P02 in partnership with a contract research organization (“CRO”). Given the transfer of development activities
to Aeterna, the percentage of Study P02 clinical trial costs that Novo is required to reimburse to Aeterna was adjusted from 70% to 100%
of costs up to €9,000 (approximately $10,980). Any additional external jointly approved Study P02 trial costs incurred over €9,000
will be shared equally between Novo and Aeterna. In addition, certain changes to rights and responsibilities of the joint steering committee
were made
Under
the Amendment, both companies will continue to closely coordinate the activities related to the development and commercialization of
macimorelin in the U.S. and Canada through a joint steering committee, with each party having decision rights in certain areas. Novo
will also receive co-ownership of the U.S. and Canadian patents and trademarks owned by Aeterna on macimorelin but will be required
to transfer co-ownership in those patents back to Aeterna on the occurrence of certain termination events.
In
addition, upon regulatory approval of macimorelin in the U.S. for the diagnosis of CGHD, if Novo determines not to commercialize
macimorelin in Canada, then Aeterna has the option to exclusively license rights to macimorelin in Canada (but not in U.S.) to a third
party. The Amendment also confirms that Aeterna has the right to use the results from Study P02, if successful, to support Aeterna in
seeking regulatory approval and in its ongoing efforts to seek partnering opportunities for macimorelin in Europe and other regions outside
of the two countries licensed to Novo, the U.S. and Canada.
Under
the Amendment, for as long as Macrilen™ (macimorelin) is patent-protected, the Company will be entitled to a 8.5% royalty on net
sales up to $40 million, 15% royalty on net sales between $40 million and $75 million, and an 18% royalty on net sales above $75 million.
Following the end of patent protection in the U.S. or Canada for Macrilen™ (macimorelin), the Company will be entitled to a 5%
royalty on net sales in that country.
In
addition, the Company will also receive one-time payments from Novo following the first achievement of the following commercial
milestone events:
|
● |
$4
million on achieving $25 million annual net sales, |
|
|
|
|
● |
$10
million on achieving $50 million annual net sales, |
|
|
|
|
● |
$20
million on achieving $100 million annual net sales, |
|
|
|
|
● |
$40
million on achieving $200 million annual net sales, and |
|
|
|
|
● |
$100
million on achieving $500 million annual net sales. |
The
Amendment will expire at the end of a defined royalty period in each of the U.S. and Canada, at which time the license that the Company
granted will become irrevocable, fully paid-up, perpetual and royalty-free in such country. The licensee has the right to terminate the
Amendment if there is a safety concern related to Macrilen™ (macimorelin), withdrawal of regulatory approval for Macrilen™
(macimorelin) in the U.S. believed to be permanent, two hundred and seventy (270) days prior written notice, or if the Company commits
a material breach of any term of the Amendment that it fails to cure within ninety (90) days after receiving written notice of the breach.
The Company has the right to terminate the Amendment if the licensee commits a material breach of any term of the Amendment that it fails
to cure within ninety (90) days after receiving written notice of the breach. If the breach relates to Canada then the Company shall
only have the right to terminate the Amendment in relation to Canada. If the breach relates to the U.S., then the Company shall have
the right to terminate the Amendment in its entirety. If Novo terminates the Amendment early or the Company terminates because
of a material breach by Novo, then the joint ownership rights will be returned to the Company.
The
Amendment contains customary provisions related to, among other things, confidentiality and non-disclosure, representations and warranties,
indemnity and dispute resolution. The Amendment is governed by the laws of Switzerland.
European
Economic Area and United Kingdom License Agreement
On
December 7, 2020, the Company entered into an exclusive licensing agreement with Consilient Health Limited (“CH”) for the
commercialization of macimorelin (the “Licensed Product”) in the European Economic Area and the United Kingdom (the “CH
License Agreement”).
Under
the terms of the CH License Agreement, CH agreed to make a non-refundable, non-creditable upfront payment to the Company of $1,209 (€1.0
million), which the Company received in January 2021. The Company also is eligible to receive additional consideration, including regulatory
milestones related to agreed-upon pricing and reimbursement parameters; net sales milestones; and royalties, ranging from 10%-20% of
net sales of macimorelin, subject to reduction in certain cases, or sublicense income recorded by CH. Also on December 7, 2020, the Company
and CH entered into an exclusive supply agreement, pursuant to which the Company agreed to provide the Licensed Product to CH, with such
Licensed Product to be manufactured by third-party manufacturers for a period of ten years, subject to renewal (the “CH Supply
Agreement”).
As
consideration for the right to commercialise the licensed product, CH has agreed certain milestones as summarized below:
One-time
payment (non-refundable and non-creditable)
|
● |
Payment
of Euro 1 million thirty (30) days after the effective date of the Licensing Agreement; |
Paediatric
Use Regulatory payment (non-refundable and non-creditable)
|
● |
Grant
of first marketing authorization from the European Commission for Paediatric Use of Euro 500,000. |
Regulatory
payments (non-refundable and non-creditable)
|
● |
Upon
receipt of pricing and reimbursement approval in France, Germany, Italy, Spain and the United Kingdom upon price per test of: |
|
● |
Above
Euro 300: Euro 200,000 per country; |
|
|
|
|
● |
Euro
250 to Euro 300: Euro 100,000 per country; and |
|
|
|
|
● |
Achievement
of a mean average reimbursement price of above Euro 300 in France, Germany, Italy, Spain and UK of Euro 500,000. |
Commercial
milestones (non-refundable and non-creditable)
|
● |
Annual
net sales reaching Euro 4 million for payment of Euro 250,000; |
|
|
|
|
● |
Annual
net sales reaching Euro 6 million for payment of Euro 400,000; |
|
|
|
|
● |
Annual
net sales reaching Euro 8 million for payment of Euro 600,000; and |
|
|
|
|
● |
Annual
net sales reaching Euro 10 million for payment of Euro 1,000,000. |
Royalties
|
● |
10.0%
for up to Euro 2 million annual net sales; |
|
|
|
|
● |
12.5%
between Euro 2 million and Euro 3 million net sales; |
|
|
|
|
● |
15.0%
between Euro 3 million and Euro 4 million net sales; and |
|
|
|
|
● |
20.0%
for above Euro 4 million net sales. |
Sublicense
Income Royalty
|
● |
10.0%
on any form of consideration other than running royalties on net sales |
The
license remains in full force and effect (i) as long as the licensed product is covered by a valid claim in any country covered by the
licensing agreement; (ii) the expiration of any regulatory marketing exclusivity period or other statutory designation that provides
similar exclusivity for the commercialisation of the licensed product in any country covered by the licensing agreement; or (iii) on
a country by country of the covered territory, and licensed product by licensed product basis, for a period of ten (10) years after the
first commercial sale date in the respective country, whichever term is longer, subject to renewal. The licensee has the right to terminate
the license in certain circumstances.
Employment
and Service Agreements
We,
or one of our subsidiaries, had entered into an employment agreement and, in some cases, a change of control agreement with each of our
Named Executive Officers.
Klaus
Paulini
We
entered into an employment agreement with Dr. Klaus Paulini, effective as of October 4, 2019 (the “Employment Agreement”)
for his position as Chief Executive Officer of the Corporation. The Corporation, through AEZS Germany, also entered into a service agreement
with Dr. Klaus Paulini effective as of July 26, 2019 (the “Services Agreement”) for his position as Managing Director
of AEZS Germany. The Employment Agreement provides that we will pay Dr. Paulini (the “Executive”) an initial base
salary of €260,000 per annum, which includes payment for his service as Managing Director of AEZS Germany. Additionally, pursuant
to the Employment Agreement, we provided the Executive with an initial grant of 35,000 stock options in November 2019. Under the terms
of the Services Agreement, the Executive may receive subsequent grants of stock options at the discretion of the Board of Directors or
the NGCC, an annual bonus subject to the determination and approval of the NGCC and participation in an employer sponsored pension scheme.
If
there is a termination of the Executive’s employment by us without “Cause”, then the Executive will be entitled to
receive a severance payment in the amount equal to €300,000.
The
Employment Agreement contains customary confidentiality, intellectual property and non-disparagement covenants.
For
the purposes of the Employment Agreement, termination of employment for “Cause” includes (but is not limited to) (i) if the
Executive commits any fraud, theft, embezzlement or other criminal act of a similar nature, and (ii) if the Executive has committed serious
misconduct or willful negligence in the performance of his duties.
Leslie
Auld
We
entered into a consulting agreement with Leslie Auld, Senior Vice President, Chief Financial Officer, effective as of September 24, 2018
(the “Consulting Agreement”). The Consulting Agreement provides that Ms. Auld (the “Consultant”)
will perform specified services for us for up to 120 hours per month. The Consultant will be paid CAN$150 per hour (plus HST) (the “base
fees”) for these services. Additionally, the Consultant will be paid for up to eight (8) hours of travel time per round trip,
at a rate of CAN$150 per hour.
The
Consulting Agreement may be terminated by either party for convenience, upon thirty (30) days written notice. The Consulting Agreement
may also be terminated by us upon the material breach or default of any provision of the Consulting Agreement by the Consultant, immediately
upon the Consultant’s death or upon the parties’ mutual agreement. In the event of termination, the Consultant will be entitled
to receive any outstanding base fees and reimbursement for incurred expenses to the effective date of termination.
The
Consulting Agreement provides the Consultant indemnifies us from and against any and all claims, costs, liabilities, damages, charges
and expenses arising out of the Consulting Agreement or the services, including in respect of misclassification.
Ms.
Auld concluded her Consulting Agreement effective March 31, 2022.
Matthias
Gerlach
AEZS
Germany entered into an employment agreement in January 2001 with Dr. Gerlach, Vice President Manufacturing and Supply Chain. In accordance
with the terms of his employment agreement, Dr. Gerlach will receive a pension payment after he has reached the statutory retirement
age, independent of whether he works with AEZS Germany until such age, in an amount to be based on the contributions that were made during
his employment with AEZS Germany.
Eckhard
Guenther
AEZS
Germany entered into an employment agreement in 1990 with Dr. Guenther, Vice President Business Development & Alliance Management.
In accordance with the terms of his employment agreement, Dr. Guenther will receive a pension payment after he has reached the statutory
retirement age, independent of whether he works with AEZS Germany until such age, in an amount to be based on the contributions that
were made during his employment with AEZS Germany.
Nicola
Ammer
AEZS
Germany entered into an employment agreement in April 2015 with Dr. Ammer, Chief Medical Officer and Senior Vice President Clinical Development.
In accordance with the terms of her employment agreement, Dr. Ammer will receive a pension payment after she has reached the statutory
retirement age, independent of whether she works with AEZS Germany until such age, in an amount to be based on the contributions that
were made during her employment with AEZS Germany.
Name | |
Termination
Provisions Value
($)(1) (2) | |
Ammer, Nicola | |
| 0 | |
Auld, Leslie | |
| 0 | |
Gerlach, Matthias | |
| 0 | |
Guenther, Eckhard | |
| 0 | |
Paulini, Klaus | |
| 354,600 | |
(1) |
The
termination values assume that the triggering event took place on the last business day of our financial year-end (December 31, 2021). |
|
|
(2) |
Value
of earned/unused vacation, if applicable, and amounts owing for expense reimbursement are not included as they are not considered
as “incremental” payments made in connection with termination of employment. |
Canada
has no system of exchange controls. There are no exchange restrictions on borrowing from foreign countries or on the remittance of dividends,
interest, royalties and similar payments, management fees, loan repayments, settlement of trade debts or the repatriation of capital.
THE
FOLLOWING SUMMARY IS OF A GENERAL NATURE ONLY AND IS NOT INTENDED TO BE, NOR SHOULD IT BE CONSTRUED TO BE, LEGAL OR TAX ADVICE TO ANY
PARTICULAR HOLDER. CONSEQUENTLY, HOLDERS ARE URGED TO CONSULT THEIR OWN TAX ADVISORS FOR ADVICE AS TO THE TAX CONSEQUENCES OF AN INVESTMENT
IN THE COMMON SHARES HAVING REGARD TO THEIR PARTICULAR CIRCUMSTANCES.
Material
Canadian Income Tax Considerations
The
following summary describes the principal Canadian federal income tax considerations applicable to a holder of Common Shares and who,
for the purposes of the Canadian federal Income Tax Act, R.S.C. 1985, as amended (the “Tax Act”), and at all relevant
times, deals at arm’s length with, and is not affiliated with, the Company and holds their Common Shares as capital property (a
“holder”). Common Shares will generally be considered to be capital property to a holder for purposes of the Tax Act
unless either the holder holds such Common Shares in the course of carrying on a business of trading or dealing in securities, or the
holder has held or acquired such Common Shares in a transaction or transactions considered to be an adventure in the nature of trade.
This
summary is not applicable to a holder (i) that is a “financial institution”, as defined in the Tax Act for purposes of the
mark-to- market rules, (ii) that is a “specified financial institution”, as defined in the Tax Act, (iii) an interest in
which would be a “tax shelter investment” as defined in the Tax Act, (iv) that has made a functional currency reporting election
for purposes of the Tax Act, (v) that has entered or will enter into a “derivative forward agreement”, as defined in the
Tax Act, in respect of Common Shares, or (vi) that receives dividends on Common Shares under or as part of a dividend rental arrangement
as defined in the Tax Act. Such holders should consult their own tax advisors.
Additional
considerations, not discussed herein, may be applicable to a holder that is a corporation resident in Canada, and is, or becomes, or
does not deal at arm’s length for purposes of the Tax Act with a corporation resident in Canada that is or becomes, as part of
a transaction or series of transactions or events that includes the acquisition of the Common Shares, controlled by a non-resident person
or a group of non-resident persons not dealing with each other at arm’s length for the purposes of the “foreign affiliate
dumping” rules in section 212.3 of the Tax Act. Such holders should consult their tax advisors with respect to the consequences
of acquiring Common Shares.
This
summary is based upon the current provisions of the Tax Act and the regulations promulgated thereunder (the “Regulations”)
and the Company’s understanding of the current published administrative policies and assessing practices of the Canada Revenue
Agency (“CRA”). It also takes into account all proposed amendments to the Tax Act and the Regulations publicly released
by the Minister of Finance (Canada) prior to the date hereof (“Tax Proposals”), and assumes that all such Tax Proposals
will be enacted as currently proposed. No assurance can be given that the Tax Proposals will be enacted in the form proposed or at all.
This summary does not otherwise take into account or anticipate any changes in law or administrative or assessing practice or policy
of the CRA, whether by legislative, regulatory, judicial or administrative action or interpretation, nor does it address any provincial,
local, territorial or foreign tax considerations.
For
purposes of the Tax Act, all amounts, including dividends, adjusted cost base and proceeds of disposition, must generally be determined
in Canadian dollars. Amounts denominated in a foreign currency must be converted to Canadian currency using exchange rates determined
in accordance with the Tax Act. The amount of any capital gain or any capital loss to a holder with respect to the Common Shares may
be affected by fluctuations in Canadian dollar exchange rates.
Holders
Not Resident in Canada
The
following discussion applies to a holder who, at all relevant times, for purposes of the Tax Act, is neither resident nor deemed to be
resident in Canada and does not, and is not deemed to, use or hold Common Shares in carrying on a business or part of a business in Canada
(a “Non-Resident holder”). In addition, this discussion does not apply to an insurer who carries or is deemed to carry
on, an insurance business in Canada and elsewhere.
Disposition
of Common Shares
A
Non-Resident holder generally will not be subject to tax under the Tax Act in respect of any capital gain realized by such Non- Resident
holder on a disposition or deemed disposition of Common Shares unless such shares constitute “taxable Canadian property”
(as defined in the Tax Act) of the Non-Resident holder at the time of disposition and the gain is not exempt from tax pursuant to the
terms of an applicable income tax treaty or convention. As long as the Common Shares are listed on a designated stock exchange (which
currently includes the NASDAQ and the TSX) at the time of their disposition, the Common Shares generally will not constitute taxable
Canadian property of a Non-Resident holder, unless (a) at any time during the 60-month period immediately preceding the disposition (i)
one or any combination of (A) the Non-Resident holder, (B) persons with whom the Non-Resident holder did not deal at arm’s length,
and (C) partnerships in which the Non-Resident holder or a person described in (B) holds a membership interest directly or indirectly
through one or more partnerships, owned 25% or more of the issued shares of any class or series of shares of the Company; and (ii) more
than 50% of the fair market value of the shares of the Company was derived directly or indirectly from one or any combination of real
or immovable property situated in Canada, “Canadian resource properties” (as defined in the Tax Act), “timber resource
properties” (as defined in the Tax Act) or options in respect of, or interests in, or for civil law rights in, any such property
whether or not such property exists or (b) the Common Shares are otherwise deemed to be taxable Canadian property to the Non-Resident
holder.
A
Non-Resident holder’s capital gain (or capital loss) in respect of Common Shares that constitute or are deemed to constitute taxable
Canadian property (and are not “treaty-protected property” as defined in the Tax Act) will generally be computed in the manner
described below under the heading “Holders Resident in Canada - Disposition of Common Shares”. If the Common Shares were
to cease being listed on the NASDAQ, the TSX or another “recognized stock exchange” (as defined in the Tax Act), a Non-Resident
holder who disposes of Common Shares that are taxable Canadian property may be required to fulfill the requirements of section 116 of
the Tax Act, unless the Common Shares are “treaty-protected property” (as defined in the Tax Act) of the disposing Non-Resident
holder.
Non-Resident
holders whose Common Shares are taxable Canadian property should consult their own tax advisors.
Taxation
of Dividends on Common Shares
Dividends
paid or credited or deemed to be paid or credited to a Non-Resident holder by the Company are subject to Canadian withholding tax at
the rate of 25% unless reduced by the terms of an applicable tax treaty or convention. Under the Canada - United States Tax Convention
(1980) (the “Convention”) as amended, the rate of withholding tax on dividends paid or credited to a Non-Resident
holder who is the beneficial owner of the dividends, is resident in the U.S. for purposes of the Convention and entitled to the benefits
of the Convention (a “U.S. holder”) is generally limited to 15% of the gross amount of the dividend (or 5% in the
case of a U.S. holder that is a company beneficially owning at least 10% of the Company’s voting shares). Non-Resident holders
should consult their own tax advisors.
Holders
Resident in Canada
The
following discussion applies to a holder of Common Shares who, at all relevant times, for purposes of the Tax Act, is or is deemed to
be resident in Canada (a “Canadian holder”). Certain Canadian holders whose Common Shares might not otherwise qualify
as capital property may, in certain circumstances, treat the Common Shares and every other “Canadian security” (as defined
in the Tax Act) owned by the Canadian holder as capital property by making an irrevocable election provided by subsection 39(4) of the
Tax Act. Canadian holders should consult their own tax advisors for advice as to whether an election under subsection 39(4) of the Tax
Act is available and/or advisable in their particular circumstances.
Taxation
of Dividends on Common Shares
Dividends
received or deemed to have been received on the Common Shares will be included in a Canadian holder’s income for purposes of the
Tax Act. Such dividends received or deemed to have been received by a Canadian holder that is an individual (other than certain trusts)
will be subject to the gross-up and dividend tax credit rules generally applicable under the Tax Act in respect of dividends received
on shares of taxable Canadian corporations. Generally, a dividend will be eligible for the enhanced gross-up and dividend tax credit
if the Company designates the dividend as an “eligible dividend” (within the meaning of the Tax Act) in accordance with the
provisions of the Tax Act. There may be limitations on the ability of the Company to designate dividends as eligible dividends. A Canadian
holder that is a corporation will be required to include such dividends in computing its income and will generally be entitled to deduct
the amount of such dividends in computing its taxable income. In certain circumstances, subsection 55(2) of the Tax Act may treat a taxable
dividend received by a Canadian holder that is a corporation as proceeds of disposition or a capital gain. A Canadian holder that is
a “private corporation” or a “subject corporation” (as such terms are defined in the Tax Act), may be liable
under Part IV of the Tax Act to pay a refundable tax on dividends received or deemed to have been received on the Common Shares to the
extent such dividends are deductible in computing the holder’s taxable income.
Disposition
of Common Shares
A
disposition, or a deemed disposition, of a Common Share by a Canadian holder will generally give rise to a capital gain (or a capital
loss) equal to the amount by which the proceeds of disposition of the share, net of any reasonable costs of disposition, exceed (or are
less than) the adjusted cost base of the share to the holder. Such capital gain (or capital loss) will be subject to the treatment described
below under “Taxation of Capital Gains and Capital Losses”.
Additional
Refundable Tax
A
Canadian holder that is a “Canadian-controlled private corporation” (as such term is defined in the Tax Act) may be liable
to pay an additional refundable tax on certain investment income including amounts in respect of “Taxable Capital Gains”,
as defined below.
Taxation
of Capital Gains and Capital Losses
In
general, one half of any capital gain (a “Taxable Capital Gain”) realized by a Canadian holder in a taxation year
will be included in the holder’s income in the year. Subject to and in accordance with the provisions of the Tax Act, one half
of any capital loss (an “Allowable Capital Loss”) realized by a Canadian holder in a taxation year must be deducted
from Taxable Capital Gains realized by the holder in the year and Allowable Capital Losses in excess of Taxable Capital Gains may be
carried back and deducted in any of the three preceding taxation years or carried forward and deducted in any subsequent taxation year
against net Taxable Capital Gains realized in such years. The amount of any capital loss realized by a Canadian holder that is a corporation
on the disposition or deemed disposition of a Common Share may be reduced by the amount of dividends received or deemed to have been
received by it on such Common Share (or on a share for which the Common Share has been substituted) to the extent and under the circumstances
prescribed by the Tax Act. Similar rules may apply where a corporation is a member of a partnership or a beneficiary of a trust that
owns Common Shares, directly or indirectly, through a partnership or a trust.
Alternative
Minimum Tax
A
Taxable Capital Gain realized and taxable dividends received or deemed to have been received by a Canadian holder who is an individual
(including a trust, other than certain specified trusts) may give rise to liability for alternative minimum tax.
Material
U.S. Federal Income Tax Considerations
The
following discussion is a summary of the material U.S. federal income tax consequences applicable to the purchase, ownership and disposition
of Common Shares by a U.S. Holder (as defined below), but does not purport to be a complete analysis of all potential U.S. federal income
tax effects. This summary is based on the Internal Revenue Code of 1986, as amended (the “Code”), U.S. Treasury regulations
promulgated thereunder, IRS rulings and judicial decisions in effect on the date hereof. All of these are subject to change, possibly
with retroactive effect, or different interpretations. This summary does not discuss the potential effects, whether adverse or beneficial,
of any proposed legislation that, if enacted, could be applied on a retroactive basis. This summary is not binding on the IRS, and the
IRS is not precluded from taking a position that is different from, and contrary to, the positions taken in this summary.
This
summary does not address all aspects of U.S. federal income taxation that may be relevant to particular U.S. Holders in light of their
specific circumstances (for example, U.S. Holders subject to the alternative minimum tax or the Medicare contribution tax on net investment
income under the Code) or to holders that may be subject to special rules under U.S. federal income tax law, including:
● |
dealers
in stocks, securities or currencies; |
|
|
● |
securities
traders that use a mark-to-market accounting method; |
|
|
● |
banks
and financial institutions; |
|
|
● |
insurance
companies; |
|
|
● |
regulated
investment companies; |
|
|
● |
real
estate investment trusts; |
|
|
● |
tax-exempt
organizations; |
|
|
● |
retirement
plans, individual plans, individual retirement accounts and tax-deferred accounts; |
|
|
● |
partnerships
or other pass-through entities for U.S. federal income tax purposes and their partners or members; |
|
|
● |
persons
holding Common Shares as part of a hedging or conversion transaction straddle or other integrated or risk reduction transaction; |
|
|
● |
persons
who or that are, or may become, subject to the expatriation provisions of the Code; |
|
|
● |
persons
whose functional currency is not the U.S. dollar; and |
|
|
● |
direct,
indirect or constructive owners of 10% or more of the total combined voting power of all classes of our voting stock or 10% or more
of the total value of shares of all classes of our stock. |
This
summary also does not address the tax consequences of holding, exercising or disposing of warrants in the Company. If the Company is
a PFIC, as described below, U.S. Holders of its warrants will be subject to adverse tax rules and will not be able to make the mark-to-market
or the QEF election described below with respect to such warrants. U.S. Holders of warrants should consult their tax advisors with regard
to the U.S. federal income tax consequences of holding, exercising or disposing of warrants in the Company, including in the situation
in which the Company is classified as a PFIC.
This
summary also does not discuss any aspect of state, local or foreign law, or estate or gift tax law as applicable to U.S. Holders. In
addition, this discussion is limited to U.S. Holders holding Common Shares as capital assets. For purposes of this summary, “U.S.
Holder” means a beneficial holder of Common Shares who or that for U.S. federal income tax purposes is:
● |
an
individual citizen or resident of the U.S.; |
|
|
● |
a
corporation or other entity classified as a corporation for U.S. federal income tax purposes created or organized in or under the
laws of the U.S., any state thereof or the District of Columbia; |
|
|
● |
an
estate, the income of which is subject to U.S. federal income taxation regardless of its source; or |
|
|
● |
a
trust, if (a) a court within the U.S. is able to exercise primary supervision over the administration of such trust and one or more
“U.S. persons” (within the meaning of the Code) have the authority to control all substantial decisions of the trust,
or (b) a valid election is in effect to be treated as a U.S. person for U.S. federal income tax purposes. |
If
a partnership or other entity or arrangement classified as a partnership for U.S. federal income tax purposes holds Common Shares, the
U.S. federal income tax treatment of a partner generally will depend on the status of the partner and the activities of the partnership.
This summary does not address the tax consequences to any such partner. Such a partner should consult its own tax advisor as to the tax
consequences of the partnership purchasing, owning and disposing of Common Shares.
U.S.
HOLDERS SHOULD CONSULT THEIR OWN TAX ADVISORS WITH REGARD TO THE APPLICATION OF THE TAX CONSEQUENCES DESCRIBED BELOW TO THEIR PARTICULAR
SITUATIONS AS WELL AS THE APPLICATION OF ANY STATE, LOCAL, FOREIGN OR OTHER TAX LAWS, INCLUDING GIFT AND ESTATE TAX LAWS.
Tax
Consequences if we are a Passive Foreign Investment Company (“PFIC”)
A
foreign corporation will be classified as a PFIC for any taxable year in which, after taking into account the income and assets of the
corporation and certain subsidiaries pursuant to applicable “look-through rules”, either (i) at least 75% of its gross income
is “passive income” or (ii) at least 50% of the average quarterly value of its assets is attributable to assets which produce
passive income or are held for the production of passive income. Passive income generally includes dividends, interest, rents and royalties
(other than certain rents and royalties derived in the active conduct of a trade or business), annuities and gains from assets that produce
passive income. If a non-U.S. corporation owns at least 25% by value of the stock of another corporation, the non-U.S. corporation is
treated for purposes of the PFIC tests as owning its proportionate share of the assets of the other corporation and as receiving directly
its proportionate share of the other corporation’s income.
The
Company believes it was a PFIC for the 2015 taxable year, but not for the 2016, 2017, 2018, 2019 or 2020 taxable years. However, the
fair market value of the Company’s assets may be determined in large part by the market price of the Common Shares, which is likely
to fluctuate, and the composition of the Company’s income and assets will be affected by how, and how quickly, the Company spends
any cash that is raised in any financing transaction. Thus, no assurance can be provided that the Company will not be classified as a
PFIC for the 2021 taxable year or any future taxable year. U.S. Holders should consult their tax advisors regarding the Company’s
PFIC status.
If
the Company is classified as a PFIC for any taxable year during which a U.S. Holder owns Common Shares, the U.S. Holder, absent certain
elections (including the mark-to-market and QEF elections described below), will generally be subject to adverse rules (regardless of
whether the Company continues to be classified as a PFIC) with respect to (i) any “excess distributions” (generally, any
distributions received by the U.S. Holder on the Common Shares in a taxable year that are greater than 125% of the average annual distributions
received by the U.S. Holder in the three preceding taxable years or, if shorter, the U.S. Holder’s holding period for the Common
Shares) and (ii) any gain realized on the sale or other disposition of the Common Shares.
Under
these adverse rules (a) the excess distribution or gain will be allocated ratably over the U.S. Holder’s holding period, (b) the
amount allocated to the current taxable year and any taxable year prior to the first taxable year in which the Company is classified
as a PFIC will be taxed as ordinary income and (c) the amount allocated to each of the other taxable years during which the Company was
classified as a PFIC will be subject to tax at the highest rate of tax in effect for the applicable category of taxpayer for that year
and an interest charge will be imposed with respect to the resulting tax attributable to each such other taxable year. A U.S. Holder
that is not a corporation will be required to treat any such interest paid as “personal interest”, which is not deductible.
U.S.
Holders can avoid the adverse rules described above in part by making a mark-to-market election with respect to the Common Shares, provided
that the Common Shares are “marketable”. The Common Shares will be marketable if they are “regularly traded”
on a “qualified exchange” or other market within the meaning of applicable U.S. Treasury regulations. For this purpose, the
Common Shares generally will be considered to be regularly traded during any calendar year during which they are traded, other than in
de minimis quantities, on at least 15 days during each calendar quarter. The Common Shares are currently listed on the NASDAQ, which
constitutes a qualified exchange; however, there can be no assurance that the Common Shares will be treated as regularly traded for purposes
of the mark-to-market election on a qualified exchange. If the Common Shares were not regularly traded on the NASDAQ or were delisted
from the NASDAQ and were not traded on another qualified exchange for the requisite time period described above, the mark-to-market election
would not be available.
A
U.S. Holder that makes a mark-to-market election must include in gross income, as ordinary income, for each taxable year an amount equal
to the excess, if any, of the fair market value of the U.S. Holder’s Common Shares at the close of the taxable year over the U.S.
Holder’s adjusted tax basis in the Common Shares. An electing U.S. Holder may also claim an ordinary loss deduction for the excess,
if any, of the U.S. Holder’s adjusted tax basis in the Common Shares over the fair market value of the Common Shares at the close
of the taxable year, but this deduction is allowable only to the extent of any net mark-to-market gains previously included in income.
A U.S. Holder that makes a mark-to-market election generally will adjust such U.S. Holder’s tax basis in the Common Shares to reflect
the amount included in gross income or allowed as a deduction because of such mark-to-market election. Gains from an actual sale or other
disposition of the Common Shares will be treated as ordinary income, and any losses incurred on a sale or other disposition of the Common
Shares will be treated as ordinary losses to the extent of any net mark-to-market gains previously included in income.
If
the Company is classified as a PFIC for any taxable year in which a U.S. Holder owns Common Shares but before a mark-to-market election
is made, the adverse PFIC rules described above will apply to any mark-to-market gain recognized in the year the election is made. Otherwise,
a mark-to-market election will be effective for the taxable year for which the election is made and all subsequent taxable years. The
election cannot be revoked without the consent of the IRS unless the Common Shares cease to be marketable, in which case the election
is automatically terminated.
If
the Company is classified as a PFIC, a U.S. Holder of Common Shares will generally be treated as owning stock owned by the Company in
any direct or indirect subsidiaries that are also PFICs and will be subject to similar adverse rules with respect to distributions to
the Company by, and dispositions by the Company of, the stock of such subsidiaries. A mark-to-market election is not permitted for the
shares of any subsidiary of the Company that is also classified as a PFIC. U.S. Holders should consult their tax advisors regarding the
availability of, and procedure for making, a mark-to-market election.
In
some cases, a shareholder of a PFIC can avoid the interest charge and the other adverse PFIC consequences described above by making a
QEF election to be taxed currently on its share of the PFIC’s undistributed income. We will endeavor to satisfy the record keeping
requirements that apply to a QEF and to supply requesting U.S. Holders with the information that such U.S. Holders are required to report
under the QEF rules. However, there can be no assurance that the Company will satisfy the record keeping requirements or provide the
information required to be reported by U.S. Holders.
A
U.S. Holder that makes a timely and effective QEF election for the first tax year in which its holding period of its Common Shares begins
generally will not be subject to the adverse PFIC consequences described above with respect to its Common Shares. Rather, a U.S. Holder
that makes a timely and effective QEF election will be subject to U.S. federal income tax on such U.S. Holder’s pro rata share
of (a) the Company’s net capital gain, which will be taxed as long-term capital gain to such U.S. Holder, and (b) the Company’s
ordinary earnings, which will be taxed as ordinary income to such U.S. Holder, in each case regardless of which such amounts are actually
distributed to the U.S. Holder by the Company. Generally, “net capital gain” is the excess of (i) net long-term capital gain
over (ii) net short-term capital loss, and “ordinary earnings” are the excess of (A) “earnings and profits” over
(B) net capital gain.
A
U.S. Holder that makes a timely and effective QEF election with respect to the Company generally (a) may receive a tax-free distribution
from us to the extent that such distribution represents “earnings and profits” that were previously included in income by
the U.S. Holder because of such QEF election and (b) will adjust such U.S. Holder’s tax basis in the Common Shares to reflect the
amount included in income or allowed as a tax-free distribution because of such QEF election. In addition, a U.S. Holder that makes a
QEF election generally will recognize capital gain or loss on the sale or other taxable disposition of Common Shares.
The
QEF election is made on a shareholder-by-shareholder basis. Once made, a QEF election will apply to the tax year for which the QEF election
is made and to all subsequent tax years, unless the QEF election is invalidated or terminated or the IRS consents to revocation of the
QEF election. In addition, if a U.S. Holder makes a QEF election, the QEF election will remain in effect (although it will not be applicable)
during those tax years in which the Company is not a PFIC.
If
the Company is classified as a PFIC and then ceases to be so classified, a U.S. Holder may make an election (a “deemed sale
election”) to be treated for U.S. federal income tax purposes as having sold such U.S. Holder’s Common Shares on the
last day of the taxable year of the Company during which it was a PFIC. A U.S. Holder that made a deemed sale election would then cease
to be treated as owning stock in a PFIC by reason of ownership of Common Shares in the Company. However, gain recognized as a result
of making the deemed sale election would be subject to the adverse rules described above and loss would not be recognized.
If
the Company is a PFIC in any year with respect to a U.S. Holder, the U.S. Holder will be required to file an annual information return
on IRS Form 8621 regarding distributions received on Common Shares and any gain realized on the disposition of Common Shares.
In
addition, if the Company is a PFIC, U.S. Holders will generally be required to file an annual information return with the IRS (also on
IRS Form 8621, which PFIC shareholders are required to file with their U.S. federal income tax or information returns) relating to their
ownership of Common Shares.
U.S.
Holders should consult their tax advisors regarding the potential application of the PFIC regime and any reporting obligations to which
they may be subject under that regime.
Dividends
Subject
to the PFIC rules discussed above, any distributions paid by the Company out of current or accumulated earnings and profits (as determined
for U.S. federal income tax purposes), before reduction for any Canadian withholding tax paid with respect thereto, will generally be
taxable to a U.S. Holder as foreign source dividend income, and generally will not be eligible for the dividends received deduction generally
allowed to corporations.
Distributions
in excess of current and accumulated earnings and profits will be treated as a non-taxable return of capital to the extent of the U.S.
Holder’s adjusted tax basis in the Common Shares and thereafter as capital gain. The Company does not, however, intend to calculate
its earnings and profits under U.S. federal income tax principles. Therefore, U.S. Holders should expect that any distribution from the
Company generally will be treated for U.S. federal income tax purposes as a dividend. U.S. Holders should consult their own tax advisors
with respect to the appropriate U.S. federal income tax treatment of any distribution received from the Company.
Dividends
paid to non-corporate U.S. Holders by the Company in a taxable year in which it is treated as a PFIC, or in the immediately following
taxable year, will not be eligible for the special reduced rates normally applicable to long-term capital gains. In all other taxable
years, dividends paid by the Company should be taxable to a non-corporate U.S. Holder at the special reduced rates normally applicable
to long-term capital gains, provided that certain conditions are satisfied. (including a minimum holding period requirement). The Company
believes it was not a PFIC for the 2020 taxable year. However, no assurance can be provided that the Company will not be classified as
a PFIC for 2021 and, therefore, no assurance can be provided that a U.S. Holder will be able to claim a reduced rate for dividends paid
in 2021 or 2022 (if any). Please see the subsection above entitled “Material U.S. Federal Income Tax Considerations—’Tax
Consequences if we are a Passive Foreign Investment Company’” for a more detailed discussion.
Under
current law, payments of dividends by the Company to non-Canadian investors are generally subject to a 25% Canadian withholding tax.
The rate of withholding tax applicable to U.S. Holders that are eligible for benefits under the Canada-United States Tax Convention (the
“Convention”) is reduced to a maximum of 15%. This reduced rate of withholding will not apply if the dividends received
by a U.S. Holder are effectively connected with a permanent establishment of the U.S. Holder in Canada. For U.S. federal income tax purposes,
U.S. Holders will be treated as having received the amount of Canadian taxes withheld by the Company, and as then having paid over the
withheld taxes to the Canadian taxing authorities. As a result of this rule, the amount of dividend income included in gross income for
U.S. federal income tax purposes by a U.S. Holder with respect to a payment of dividends may be greater than the amount of cash actually
received (or receivable) by the U.S. Holder from the Company with respect to the payment.
Subject
to certain limitations, a U.S. Holder will generally be entitled, at the election of the U.S. Holder, to a credit against its U.S. federal
income tax liability, or a deduction in computing its U.S. federal taxable income, for Canadian income taxes withheld by the Company.
This election is made on a year-by-year basis and applies to all foreign taxes paid (whether directly or through withholding) by a U.S.
Holder during a year. For purposes of the foreign tax credit limitation, dividends paid by the Company generally will constitute foreign
source income in the “passive category income” basket. The foreign tax credit rules are complex and U.S. Holders should consult
their tax advisors concerning the availability of the foreign tax credit in their particular circumstances.
Dividends
paid in Canadian dollars will be included in the gross income of a U.S. Holder in a U.S. dollar amount calculated by reference to the
exchange rate in effect on the date the U.S. Holder (actually or constructively) receives the dividend, regardless of whether such Canadian
dollars are actually converted into U.S. dollars at that time. If the Canadian dollars received are not converted into U.S. dollars on
the date of receipt, a U.S. Holder will have a tax basis in the Canadian dollars equal to their U.S. dollar value on the date of receipt.
Gain or loss, if any, realized on a sale or other disposition of the Canadian dollars will generally be U.S. source ordinary income or
loss to a U.S. Holder.
The
Company generally does not pay any dividends and does not anticipate paying any dividends in the foreseeable future.
Sale,
Exchange or Other Taxable Disposition of Common Shares
Subject
to the PFIC rules discussed above, upon a sale, exchange or other taxable disposition of Common Shares, a U.S. Holder generally will
recognize capital gain or loss for U.S. federal income tax purposes equal to the difference, if any, between the amount realized on the
sale, exchange or other taxable disposition and the U.S. Holder’s adjusted tax basis in the Common Shares.
This
capital gain or loss will be long-term capital gain or loss if the U.S. Holder’s holding period in the Common Shares exceeds one
year. The deductibility of capital losses is subject to limitations. Any gain or loss will generally be U.S. source for U.S. foreign
tax credit purposes.
Information
Reporting and Backup Withholding
Payments
made within the U.S., or by a U.S. payor or U.S. middleman, of dividends on, and proceeds arising from sales or other dispositions of
Common Shares, generally will be reported to the IRS and to the U.S. Holder as required under applicable regulations. Backup withholding
tax may apply to these payments if the U.S. Holder fails to timely provide in the appropriate manner an accurate taxpayer identification
number or otherwise fails to comply with, or establish an exemption from, such backup withholding tax requirements. Certain U.S. Holders
are not subject to the information reporting or backup withholding tax requirements described herein. U.S. Holders should consult their
tax advisors as to their qualification for exemption from backup withholding tax and the procedure for establishing an exemption.
Backup
withholding tax is not an additional tax. U.S. Holders generally will be allowed a refund or credit against their U.S. federal income
tax liability for amounts withheld, provided the required information is timely furnished to the IRS.
Subject
to certain exceptions and future guidance, a U.S. Holder that is a “specified individual” or a “specified domestic
entity” (as defined in the instructions to IRS Form 8938) must report annually to the IRS on IRS Form 8938 such U.S. Holder’s
interests in stock or securities issued by a non-U.S. person (such as the Company). U.S. Holders should consult their tax advisors regarding
the information reporting obligations that may arise from their acquisition, ownership or disposition of Common Shares.
F. |
Dividends
and paying agents |
Not
required.
Not
required.
In
addition to placing our audited consolidated annual financial statements before every annual meeting of shareholders as described above,
we are subject to the information requirements of the Securities Exchange Act of 1934, as amended. In accordance with these requirements,
we file and furnish reports and other information with the SEC. These materials, including this Annual Report on Form 20-F and the exhibits
hereto, may be inspected and copied at the SEC’s Public Reference Room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549.
The public may obtain information on the operation of the SEC’s Public Reference Room by calling the SEC in the U.S. at 1-800-SEC-0330.
The SEC also maintains a website at www.sec.gov that contains reports, proxy statements and other information regarding registrants that
file electronically with the SEC. Our annual reports and some of the other information we submitted to the SEC may be accessed through
this website. In addition, material we filed can be inspected on the Canadian Securities Administrators’ electronic filing system,
SEDAR, accessible at the website www.sedar.com. This material includes our Management Information Circular for our annual meeting of
shareholders to be held in 2022 to be furnished to the SEC on Form 6-K, which provides information including directors’ and officers’
remuneration and indebtedness and principal holders of securities. Additional financial information is provided in our audited annual
financial statements for the year ended December 31, 2021 and our MD&A relating to these statements included elsewhere in this Annual
Report on Form 20-F. These documents are also accessible on SEDAR (www.sedar.com) and on EDGAR (www.sec.gov).
I. |
Subsidiary
information |
Not
required.
Item
11. |
Quantitative
and Qualitative Disclosures About Market Risk |
Fair
value
The
Company classifies its financial instruments in the following categories: “Financial assets at amortized cost”; and “Financial
liabilities at amortized cost”.
● |
The
Company’s financial assets at amortized cost are comprised of cash and cash equivalents, trade and other receivables and restricted
cash equivalents. |
|
|
● |
Financial
liabilities at amortized cost include payables and accrued liabilities, and lease liability. |
The
carrying values of all of the aforementioned financial instruments approximate their fair values due to their short-term maturity or
to the prevailing interest rates of these instruments which are comparable to those of the market.
The
Black-Scholes valuation methodology uses inputs in calculating fair value, as defined in IFRS 13, which establishes
a hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices
in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).
Financial
risk factors
The
following provides disclosures relating to the nature and extent of the Company’s exposure to risks arising from financial instruments,
including credit risk, liquidity risk and foreign exchange risk and how the Company manages those risks.
Credit
risk is the risk of an unexpected loss if a customer or counterparty to a financial instrument fails to meet its contractual obligations.
The Company regularly monitors credit risk exposure and takes steps to mitigate the likelihood of this exposure resulting in losses.
The Company’s exposure to credit risk currently relates to the financial assets at amortized cost in the table above. The Company
holds its available cash in amounts that are readily convertible to known amounts of cash and deposits its cash balances with financial
institutions that have an investment grade rating of at least “P-2” or the equivalent. This information is supplied by independent
rating agencies where available and, if not available, the Company uses publicly available financial information to ensure that it invests
its cash in creditworthy and reputable financial institutions. Once there are indicators that there is no reasonable expectation of recovery,
such financial assets are written off but are still subject to enforcement activity.
As
at December 31, 2021, trade accounts receivable for an amount of approximately $0.9 million were with three counterparties of which $0.1
million was past due and impaired and fully provided for (2020 - $1.2 million with three counterparties and $0.1 million past due and
impaired and fully provided for).
Generally,
the Company does not require collateral or other security from customers for trade accounts receivable; however, credit is extended following
an evaluation of creditworthiness. In addition, the Company performs ongoing credit reviews of all of its customers and determines expected
credit losses. On this basis, as at December 31, 2021, the Company has provided for all outstanding and unpaid amounts relating to its
operations before its licensing of MacrilenTM.
The
maximum exposure to credit risk approximates the amount recognized in the Company’s consolidated statement of financial position.
Liquidity
risk is the risk that the Company will not be able to meet its financial obligations as they become due. The Company manages this risk
through the management of its capital structure. It also manages liquidity risk by continuously monitoring actual and projected cash
flows.
A
portion of the Company’s cash is held in AEZS Germany, which is the counter-party to various license and distribution agreements
for the Company’s only approved product. In September 2019 and February, July and August of 2020 and February of 2021 the Company
completed financings resulting in total funding (net of transaction costs) of $55,905. Net cash proceeds were deposited in AEZS Canada
accounts and such funds can be provided to its German subsidiary, if and when needed. During 2020, AEZS Germany signed agreements with
Novo and CH whereby AEZS Germany received cash payments of $6.1 million (€5.0 million) in fiscal 2020 and $1.2 million (€1.0
million) in January 2021, respectively, and expects to use this cash to fund its operations directly.
The
Board of Directors reviews and approves the Company’s operating and capital budgets, as well as any material transactions occurring
outside of the ordinary course of business. The Company has adopted an investment policy in respect of the safety and preservation of
its capital to ensure the Company’s liquidity needs are met. The instruments are selected with regard to the expected timing of
expenditures and prevailing interest rates.
(c) |
Foreign exchange risk |
Entities
using the Euro as their functional currency
The
Company is exposed to foreign exchange risk due to its investments in foreign operations whose functional currency is the Euro. As at
December 31, 2021, if the US dollar had increased or decreased by 10% against the Euro, with all other variables held constant, net loss
for the year ended December 31, 2021 would have been lower or higher by approximately $0.3 million (2020 - $0.1 million and 2019 - $0.8
million).
Item
12. |
Description
of Securities Other than Equity Securities |
Not
required.
Not
required.
Not
required.
D. |
American
depositary shares |
Not
applicable.
PART
III
Item
17 |
Financial
Statements |
The financial statements appear on pages [123]
to [178].
Item
18. |
Financial
Statements |
Not
applicable.
Aeterna
Zentaris Inc.
Consolidated
Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
Report
of independent registered public accounting firm
To
the shareholders and the board of directors of
Aeterna
Zentaris Inc.
Opinion
on the financial statements
We
have audited the accompanying consolidated statement of financial position of Aeterna Zentaris Inc. (the Company) as of December
31, 2021, the related consolidated statement of changes in shareholders’ equity (deficiency), comprehensive loss, and cash flows,
for the year ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company
as of December 31, 2021, and its financial performance and its cash flows for the year ended December 31, 2021, in conformity with International
Financial Reporting Standards (“IFRSs”) as issued by the International Accounting Standards Board.
Basis
for opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit,
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or
fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that
our audit provides a reasonable basis for our opinion.
Critical
audit matter
The
critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial
statements and (2) involved our especially challenging, subjective or complex judgments. The communication of critical audit matter does
not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical
audit matters below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which they relate.
Revenue
from License and Collaboration Arrangements |
|
Description
of the matter |
As
described in Note 2, Note 3 and Note 5, the Company enters into license and collaboration arrangements that may include non-refundable upfront license fees, the provision of development services, milestone payments, royalties
on future product sales and supply arrangements. The Company has recorded $5.3 million of total revenues during the year ended December
31, 2021 and $6.3 million as deferred revenues as of December 31, 2021. Management analyzes each agreement and applies
significant judgment to determine whether contracts entered into at or near the same time should be accounted for as a single arrangement
and whether all parts of the contract fall within the scope of IFRS 15. In addition, each agreement is analyzed to identify all performance
obligations and to determine whether a performance obligation is distinct or should be combined with other promised goods and services, determine
and allocate the transaction price on a relative stand-alone selling price basis, determine whether a performance obligation
is satisfied at a point in time or over time, and, for performance obligations satisfied over time, in concluding upon the appropriate
method of measuring progress to be applied for purposes of recognizing revenue. |
|
|
|
Auditing
the Company’s accounting for revenues from the license and collaboration arrangements was complex given the significant judgment
required in evaluating the terms and multiple elements of the related agreements. A high degree of auditor judgment and effort was
required in performing procedures to evaluate the reasonableness of management’s assessment to identify all performance obligations
and to determine whether a performance obligation is distinct or should be combined with other promised goods and services. |
|
|
How
we addressed the matter in our audit |
To
test the Company’s accounting for revenue from license and collaboration arrangements, our audit procedures included, among
others, obtaining and evaluating management’s accounting analyses for all significant arrangements. We inspected the Company’s
agreements and we evaluated whether management’s assessments considered all relevant terms included in the agreements. We assessed
management’s consideration of whether contracts should be accounted for as a single arrangement and whether all elements fall
within the scope of IFRS 15. We assessed management’s identification of performance obligations and whether they are distinct
or combined with other promised goods and services. We evaluated the reasonableness of management’s recognition of revenue
based on when each performance obligation will be satisfied in conformity with the Company’s accounting policies.
|
/s/
Ernst & Young LLP
We
have served as the Company’s auditor since 2021.
Montreal,
Canada
March
28, 2022
Report
of Independent Registered Public Accounting Firm
To
the Board of Directors and Shareholders of Aeterna Zentaris Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated statement of financial position of Aeterna Zentaris Inc. and its subsidiaries (together, the
Company) as of December 31, 2020, and the related consolidated statements of changes in shareholders’ equity (deficiency), comprehensive
loss and cash flows for each of the two years in the period ended December 31, 2020, including the related notes (collectively referred
to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects,
the financial position of the Company as of December 31, 2020, and its financial performance and its cash flows for each of the two years
in the period ended December 31, 2020 in conformity with International Financial Reporting Standards as issued by the International Accounting
Standards Board.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance
with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material
misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of
the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures
included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits
also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall
presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/PricewaterhouseCoopers
LLP
Chartered
Professional Accountants, Licensed Public Accountants
Toronto, Canada
March
24, 2021
We
served as the Company’s auditor from 1993 to 2021.
PricewaterhouseCoopers
LLP
PwC
Tower, 18 York Street, Suite 2600, Toronto, Ontario, Canada M5J
0B2 T: +1 416 863 1133, F: +1 416 365 8215
“PwC”
refers to PricewaterhouseCoopers LLP, an Ontario limited liability partnership.
Aeterna
Zentaris Inc.
Consolidated
Statements of Financial Position
(in
thousands of US dollars)
Commitments
and contingencies (note 27)
The
accompanying notes are an integral part of these consolidated financial statements.
Approved
by the Board of Directors
/s/
Carolyn Egbert |
|
/s/
Dennis Turpin |
Carolyn
Egbert
Chair
of the Board |
|
Dennis
Turpin
Director |
Aeterna
Zentaris Inc.
Consolidated
Statements of Changes in Shareholders’ Equity (Deficiency)
(in
thousands of US dollars, except share data)
| 1 | Issued
and paid in full. |
The
accompanying notes are an integral part of these consolidated financial statements.
Aeterna
Zentaris Inc.
Consolidated
Statements of Comprehensive Loss
(in
thousands of US dollars, except share and per share data)
The
accompanying notes are an integral part of these consolidated financial statements.
Aeterna
Zentaris Inc.
Consolidated
Statements of Cash Flows
(in
thousands of US dollars, except share data)
The accompanying notes are an integral
part of these consolidated financial statements.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Summary
of business
Aeterna
Zentaris (the “Company” or “Aeterna”) is a specialty biopharmaceutical company commercializing and developing
therapeutics and diagnostic tests. The Company’s lead product, Macrilen™ (macimorelin), is the first and only United States
(“US”) Food and Drug Administration (“FDA”) and European Medicines Agency-approved oral test indicated for the
diagnosis of patients with adult growth hormone deficiency (“AGHD”). Macrilen™ is currently marketed in the US through
a license agreement, as amended, between the Company and Novo Nordisk Health Care AG (“Novo”). The Company is also dedicated
to the development of therapeutic assets and has recently taken steps to establish a pre-clinical pipeline to potentially address unmet
medical needs across a number of indications with a focus on rare or orphan indications and with the potential for pediatric use.
COVID-19
impact
Coronavirus,
or COVID-19, a contagious disease that was characterized by the World Health Organization as a pandemic in early 2020, continues to affect
the global community.
The
spread of COVID-19 may continue to impact our operations, including the potential interruption of our clinical trial activities and of
our supply chain. For example, the rise in the Omicron variant in the COVID-19 pandemic has caused delays in site initiation and patient
enrollment in our Phase 3 DETECT clinical trial for diagnostic use in childhood-onset growth hormone deficiency. Additionally, sales
activities for Macrilen™ in the US may be impacted due to delays of diagnostic activities on AGHD in the US. Further, the COVID-19
pandemic may also cause some patients to be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if
quarantines impede patient movement or interrupt healthcare services, which would delay our ability to conduct clinical trials or release
clinical trial results on a timely basis and could delay our ability to obtain regulatory approval and commercialize our product candidates.
Management will continue to monitor and assess the impact of the pandemic on its judgments, estimates, accounting policies and amounts
recognized in these consolidated financial statements. As of December 31, 2021, the Company assessed the possible impacts of COVID-19
on its consolidated financial results. The Company has evaluated its financial assets, property, plant and equipment, intangible assets,
and goodwill for impairment and no changes from the carrying amount were required in the reporting period.
Reporting
entity
The
accompanying consolidated financial statements include the accounts of Aeterna Zentaris Inc., an entity incorporated under the Canada
Business Corporations Act, and its wholly owned subsidiaries. The Company and its subsidiaries are collectively referred to as the
“Group”. Aeterna Zentaris Inc. is the ultimate parent company of the Group. The Company currently has three wholly owned
direct and indirect subsidiaries, Aeterna Zentaris GmbH (“AEZS Germany”), based in Frankfurt, Germany, Zentaris IVF GmbH,
a wholly owned subsidiary of AEZS Germany, based in Frankfurt, Germany, and Aeterna Zentaris, Inc., an entity incorporated in the state
of Delaware and with offices in Summerville, South Carolina, in the US.
The
registered office of the Company is located at 222 Bay Street, Suite 3000, P.O. Box 53, Toronto, Ontario M5K 1E7, Canada.
The
Company’s common shares are listed on both the Toronto Stock Exchange and on the NASDAQ Capital Market.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Basis
of presentation
(a)
Statement of compliance
These
consolidated financial statements as of December 31, 2021 and December 31, 2020 and for the years ended December 31, 2021, 2020 and 2019
have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards
Board (“IFRS”).
These
consolidated financial statements were approved by the Company’s Board of Directors, subject to confirmation by the Audit Committee
of the Board of Directors, which confirmation was received on March 28, 2022.
The
preparation of financial statements in accordance with IFRS requires the use of certain critical accounting estimates and the exercise
of management’s judgment in applying the Company’s accounting policies. Areas involving a high degree of judgment or complexity
and areas where assumptions and estimates are significant to the Company’s consolidated financial statements are discussed in note
3 - Critical accounting estimates and judgments. Certain comparative figures for the year ended December 31, 2020 were reclassified
to conform to the presentation adopted for December 31, 2021.
(b)
Basis of measurement
The
consolidated financial statements have been prepared under a historical cost convention.
(c) Principles of consolidation
These
consolidated financial statements include any entity in which the Company directly or indirectly holds more than 50% of the voting rights
or over which the Company exercises control. The Company controls an entity when the Company is exposed to, or has rights to, variable
returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. An entity
is included in the consolidation from the date that control is transferred to the Company, while any entities that are sold are excluded
from the consolidation from the date that control ceases. All inter-company balances and transactions are eliminated on consolidation.
(d)
Foreign currency
Items
included in the financial statements of the Group’s entities are measured using the currency of the primary economic environment
in which the entities operate (the “functional currency”) which is the US dollar for the Company and its US subsidiary, Aeterna
Zentaris, Inc., and the Euro (“EUR” or “€”) for its German subsidiaries.
Assets
and liabilities of the German subsidiaries are translated from EUR balances at the period-end exchange rates, and the results of operations
are translated from EUR amounts at average rates of exchange for the period. The resulting translation adjustments are included in accumulated
other comprehensive loss within shareholders’ equity (deficiency).
Foreign
currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the underlying
transaction. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation of monetary
assets and liabilities not denominated in the functional currency are recognized in the consolidated statements of comprehensive loss.
2. |
Summary of significant accounting policies |
The
accounting policies set out below have been applied consistently to all years presented in these consolidated financial statements and
have been applied consistently by all Group entities.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Cash
and cash equivalents
Cash
and cash equivalents consist of unrestricted cash on hand and balances with banks, as well as short-term interest-bearing deposits, such
as money market accounts, that are readily convertible to known amounts of cash and are subject to an insignificant risk of changes in
value, with a maturity of three months or less from the date of acquisition.
Inventories
Inventories
are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The Company’s
policy is to write down inventory that has become obsolete and inventory that has a cost basis in excess of its expected net realizable
value. Increases in the reserve are recorded as charges in cost of sales. For product candidates that have not been approved by the FDA,
inventory used in clinical trials is written down at the time of production and recorded as research and development (“R&D”)
costs. For products that have been approved by the FDA, inventory used in clinical trials is expensed at the time the inventory is packaged
for the clinical trial. All direct manufacturing costs incurred after approval are capitalized into inventory.
Restricted
cash equivalents
Restricted
cash equivalents are comprised of bank deposits, which are related to a guarantee for a long-term operating lease obligation, and for
corporate credit card programs that cannot be used for current purposes.
Property,
plant and equipment and depreciation
Items
of property, plant and equipment are recorded at cost, net of accumulated depreciation and impairment charges. Depreciation is calculated
using the following methods, annual rates and period:
Summary of Depreciation Using Methods, Annual Rates and Period
| |
Methods | |
Annual rates and period |
Equipment | |
Declining balance and straight-line | |
20% |
Furniture and fixtures | |
Declining balance and straight-line | |
10% to 20% |
Computer equipment | |
Straight-line | |
25% to 331/3% |
Leasehold improvements | |
Straight-line | |
Remaining lease term |
Depreciation
expense, which is recorded in the consolidated statement of comprehensive loss, is allocated to the appropriate functional expense categories
to which the underlying items of property, plant and equipment relate.
Identifiable
intangible assets and amortization
Identifiable
intangible assets with finite useful lives consist of in-process R&D acquired in business combinations, patents, trademarks, in-licensed
technology and rights to serialization equipment located at the Company’s third-party macimorelin manufacturer. In-process R&D
acquired in business combinations is recognized at fair value at the acquisition date. Patents and trademarks are comprised of costs,
including professional fees incurred in connection with the filing of patents and the registration of trademarks for product marketing
and manufacturing purposes, net of related government grants, impairment losses and accumulated amortization. Identifiable intangible
assets with finite useful lives are amortized beginning at the time at which the assets are available for use, on a straight-line basis
over the assets’ estimated useful lives, which range from seven to 15 years for in-process R&D and patents and are ten years
for trademarks. Amortization expense, which is recorded in the consolidated statement of comprehensive loss, is allocated to the appropriate
functional expense categories to which the underlying identifiable intangible assets relate.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Contingent
payments
The
Company accounts for contingent variable payments for separately acquired intangible assets, such as in-licensed technology, under the
cost accumulation approach. Contingent consideration is not considered on initial recognition of the asset but instead is added to the
cost of the asset initially recorded, when incurred.
Goodwill
Goodwill
is recognized as the fair value of the consideration transferred, including the recognized amount of any non-controlling interest in
the acquiree, less the fair value of the net identifiable assets acquired, and liabilities assumed, as of the acquisition date. Subsequent
to initial recognition, goodwill is measured at cost less accumulated impairment losses. Goodwill acquired in business combinations is
allocated to groups of cash generating units (“CGU”) that are expected to benefit from the synergies of the combination.
Impairment
of long-lived assets
Items
of property, plant and equipment, right of use assets and identifiable intangible assets with finite lives that are subject to depreciation
or amortization, respectively, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts
of the assets may not be recoverable. Intangible assets that are not subject to amortization are tested when there are indications
that their carrying value may not be recoverable, or, at a minimum, annually. Management is required to assess at each reporting
date whether there is any indication that an asset may be impaired. Where such an indication exists, the asset’s recoverable amount
is compared to its carrying value, and an impairment loss is recognized for the amount by which the asset’s carrying amount exceeds
its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. For
purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows, or
CGU. In determining value in use of a given asset or CGU, estimated future cash flows are discounted to their present value using a pre-tax
discount rate that reflects current market assessments of the time value of money and the risks specific to the asset.
Items
of property, plant and equipment and identifiable intangible assets with finite lives that have suffered impairment are reviewed for
possible reversal of the impairment if there has been a change, since the date of the most recent impairment test, in the estimates used
to determine the impaired asset’s recoverable amount. However, an asset’s carrying amount, increased due to the reversal
of a prior impairment loss, must not exceed the carrying amount that would have been determined, net of depreciation or amortization,
had the original impairment not occurred.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Goodwill
is not subject to amortization, but instead is tested for impairment annually or more often if there is an indication that the CGU to
which the goodwill has been allocated may be impaired. Impairment is determined for goodwill by assessing whether the carrying value
of a CGU, including the allocated goodwill, exceeds the CGU’s recoverable amount, which is the higher of fair value less costs
to sell and the CGU’s value in use. Fair value less costs of disposal is determined based on the Company’s market capitalization,
as well as relevant market data, such as control premiums, and other assumptions. In the event that the carrying amount of goodwill exceeds
its recoverable amount, an impairment loss is recognized in an amount equal to the excess. Impairment losses related to goodwill, which
are recorded in the consolidated statement of comprehensive loss, are not subsequently reversed.
Provisions
Provisions
represent liabilities to the Company for which the amount or timing is uncertain. Provisions are recognized when the Company has a present
legal or constructive obligation as a result of past events, such as organizational restructuring, when it is probable that an outflow
of resources will be required to settle the obligation and where the amount can be reliably estimated. Provisions are not recognized
for future operating losses.
Provisions
are made for any contracts which are deemed onerous. A contract is onerous if the unavoidable costs of meeting the obligations under
the contract exceed the economic benefits expected to be received under it. Provisions for onerous contracts are measured at the present
value of the lower of the expected cost of terminating the contract and the expected net cost of continuing with the contract. Present
value is determined based on expected future cash flows that are discounted at a pre-tax rate that reflects current market assessments
of the time value of money and the risks specific to the liability. The unwinding of the discount is recognized in finance costs.
Leases
At
the inception of a contract, the Company assesses whether a contract is or contains a lease. A lease is a contract in which the right
to control the use of an identified asset is granted for an agreed-upon period of time in exchange for consideration. The Company assesses
whether a contract conveys the right to control the use of an identified asset when there is both the right to direct the use of the
asset and obtain substantially all the economic benefits from that use. The Company recognizes a right of use asset and a lease liability
at the lease commencement date.
The
lease liability is initially measured at the present value of the non-cancellable lease payments over the lease term and discounted at
the rate implicit in the lease. If that rate cannot be determined, the Company’s incremental borrowing rate, or the rate that Company
would have to pay to borrow the funds necessary to obtain an asset of similar value in a similar economic environment with similar terms
and conditions, is used. Lease payments include fixed payments and such variable payments that depend on an index or a rate less any
lease incentives receivable.
The
lease liability is subsequently measured at amortized cost using the effective interest method and is remeasured when there is a change
in future lease payments arising from a change in an index or rate, if there is a change in the Company’s estimate of the amount
expected to be payable under a residual value guarantee or if the Company changes its assessment of whether it will exercise a purchase,
extension or termination option. When the lease liability is remeasured, a corresponding adjustment is made to the carrying amount of
the right of use asset, with any difference recorded in the statement of comprehensive loss.
Right
of use assets are measured at cost, which comprises the initial lease liability, lease payments made at or before the lease commencement
date, initial direct costs and restoration obligations, less lease incentives. Right of use assets are subsequently measured at amortized
cost. The assets are depreciated over the shorter of the assets’ useful life and the lease terms on a straight-line basis, less
any accumulated impairment losses, and adjusted for any remeasurement of the lease liability. The lease term includes periods covered
by an option to extend if the Company is reasonably certain to exercise that option.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
Company accounts for a lease modification as a separate lease if both of the following conditions exist: (a) the modification increases
the scope of the lease by adding the right to use one or more underlying assets; and (b) the consideration for the lease increases by
an amount equivalent to the standalone price for the increase in scope and any appropriate adjustments to that stand-alone price to reflect
the circumstances of the particular contract. Where the Company accounts for a lease modification as a new lease, the separate lease
is accounted for in the same way as a new lease, as described above.
Where
the Company does not account for a lease modification as a separate lease, the lease liability is remeasured by: (a) decreasing the carrying
amount of the right of use asset to reflect the partial or full termination of the lease for lease modifications that decrease the scope
of the lease, with any gain or loss relating to the partial or full termination of the lease recorded in the consolidated statement of
comprehensive loss; or (b) making a corresponding adjustment to the right of use asset for all other lease modifications.
Payments
associated with short-term leases and leases of low-value assets are recognized on a straight-line basis as an expense in the consolidated
statement of comprehensive loss.
Employee
benefits
Salaries
and other short-term benefits
Salaries
and other short-term benefit obligations are measured on an undiscounted basis and are recognized in the consolidated statement of comprehensive
loss over the related service period or when the Company has a present legal or constructive obligation to make payments as a result
of past events and when the amount payable can be estimated reliably.
Post-employment
benefits
AEZS
Germany provides unfunded and partially funded defined benefit multi-employer pension plans, namely the DUPK pension plan and the RUK
1990 and 2006 pension plans, (the “Pension Benefit Plans”) and unfunded post-employment benefit plans for certain groups
of employees. Provisions for pension obligations are established for benefits payable in the form of retirement, disability and surviving
dependent pensions. The Company also provides a defined contribution plans to some of its employees.
For defined benefit pension plans and other post-employment benefits, net
periodic pension expense is actuarially determined on a quarterly basis using the projected unit credit method. The cost of pension and
other benefits earned by employees is determined by applying certain assumptions, including discount rates, rate of pension benefit increases,
the projected age of employees upon retirement and the expected rate of future compensation.
The
employee future benefits liability is recognized at its present value, which is determined by discounting the estimated future cash outflows
using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid and that
have terms to maturity approximating the terms of the related future benefit liability. Actuarial gains and losses that arise in calculating
the present value of the defined benefit obligation are recognized in other comprehensive loss, net of tax, and simultaneously reclassified
in the deficit in the consolidated statement of financial position in the year in which the actuarial gains and losses arise and without
recycling to the consolidated statement of comprehensive loss in subsequent periods.
For
defined contribution plans, expenses are recorded in the consolidated statement of comprehensive loss as incurred–namely, over
the period that the related employee service is rendered.
Termination
benefits
Termination
benefits are recognized in the consolidated statement of comprehensive loss when the Company is demonstrably committed, without the realistic
possibility of withdrawal, to a formal detailed plan to terminate employment earlier than originally expected. Termination benefit liabilities
expected to be settled after 12 months from the end of a given reporting period are discounted to their present value, where material.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Financial
instruments
The
Company classifies its financial instruments in the following categories: financial assets at fair value through profit or loss (“FVTPL”);
financial liabilities at FVTPL; financial assets at amortized cost; financial liabilities at amortized cost and financial assets at fair
value through other comprehensive income (“FVTOCI”).
Financial
assets at FVTPL: Financial assets carried at FVTPL are initially recorded at fair value, and transaction costs directly attributable
to issuing the financial assets are expensed in the statement of comprehensive loss. Realized and unrealized gains and losses arising
from changes in the fair value of the financial assets held at FVTPL are included in the statement of comprehensive loss in the period
in which they arise. As of December 31, 2021 and 2020, the Company did not have any financial assets at FVTPL.
Financial
liabilities at FVTPL: These financial liabilities are initially recognized at fair value, and transaction costs directly attributable
to issuing the financial liabilities are expensed in the statement of comprehensive loss. Financial liabilities that are required to
be measured at FVTPL are re-measured at each reporting date, with changes in fair value reported in the statement of comprehensive loss.
As of December 31, 2021 and 2020, the Company did not have any financial liabilities at FVTPL.
Financial
assets at amortized cost: A financial asset is measured at amortized cost if the objective of the business model is to hold the financial
asset for the collection of contractual cash flows, and the asset’s contractual cash flows are comprised solely of payments of
principal and interest. Financial assets at amortized cost are classified as current or non-current based on their maturity date and
are initially recognized at fair value and subsequently carried at amortized cost, less any impairment.
Financial
liabilities at amortized cost: Financial liabilities classified as amortized cost are initially recognized at fair value, less directly
attributable transaction costs. After initial recognition, costs are subsequently measured at amortized cost using the effective interest
rate method with interest expense recognized on an effective yield basis. The effective interest rate is the rate that discounts estimated
future cash payments through the expected life of the financial liability, or, where appropriate, a shorter period. Interest accretion
is recorded in interest expense in the consolidated statement of comprehensive loss.
Financial
assets at FVTOCI: Investments in equity instruments at FVTOCI are initially recognized at fair value, plus incremental transaction
costs. Subsequently, financial assets at FVTOCI are measured at fair value, with gains and losses arising from changes in fair value
recognized in other comprehensive loss in the period in which those gains or losses arise. As of December 31, 2021 and 2020, the Company
did not have any financial assets at FVTOCI.
Impairment
of financial assets at amortized cost: The Company applies the simplified approach on trade receivables, which allows for the use
of a lifetime expected credit loss (“ECL”) provision considering the probability of default over the expected life of the
financial asset. The 12-month ECL only considers default events that are possible within the year following the reporting date. The Company
uses a provision matrix to calculate ECLs for trade receivables. The provision matrix is initially based on the Company’s historical
observed default rates and is subsequently evaluated and updated based on new and forward-looking information.
Share
capital
Common
shares are classified as equity. Incremental costs that are directly attributable to the issuance of common shares are recognized as
a deduction from equity, net of any tax effects.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Where
offerings result in the issuance of units (where each unit is comprised of a common share of the Company and a warrant, exercisable in
order to purchase a common share or fraction thereof) and the Company does not have the unconditional right to avoid delivering cash
to the holders in the future, proceeds received in connection with those offerings are allocated between share capital and warrants.
Transaction costs in connection with such offerings are allocated to the liability and equity unit components in proportion to the allocation
of proceeds.
Where
offerings result in the issuance of units (where each unit is comprised of a common share of the Company and a warrant, exercisable in
order to purchase a common share or fraction thereof) and the warrants issued meet the fixed-for-fixed criteria, discussed below, proceeds
received in connection with those offerings are allocated between share capital and warrants based on the relative fair value method. Transaction costs in connection with
such offerings are allocated to share capital and warrant components within equity in proportion to the allocation of proceeds.
Warrants
Warrants
are classified as liabilities when the Company does not have the unconditional right to avoid delivering cash to the holders in the future,
or when they can be settled with a variable number of common shares. Each of the Company’s warrants contains a written put option,
arising upon the occurrence of a fundamental transaction, as that term is defined in the warrants, including a change of control.
The
warrant liability is initially measured at fair value, and any subsequent changes in fair value are recognized as gains or losses through
profit or loss. Any transaction costs related to the warrants are expensed as incurred. Fair value of such warrants is determined at
the issue date using the Black-Scholes option pricing model.
The
warrant liability is classified as non-current, unless the underlying warrants will expire or be settled within 12 months from the end
of a given reporting period.
When
issued warrants meet the fixed-for-fixed criteria under IAS 32, Financial Instruments, either upon initial issue or upon subsequent
registration of the common shares underlying the warrants, the Company classifies such warrants as equity-settled. Such warrants are
accounted for by using the relative fair value method whereby the total gross proceeds from the offering are allocated to each of common
shares and warrants based on their relative fair values. Fair value of such warrants is determined at the issue date using the Black-Scholes
option pricing model.
Share-based
compensation costs
The
Company operates an equity-settled share-based compensation plan under which the Company receives services from directors, senior executives,
employees and other collaborators as consideration for equity instruments of the Company. The Company accounts for all forms of share-based
compensation using the fair value-based method. Fair value of stock options is determined at the date of grant using the Black-Scholes
option pricing model, which includes estimates of the number of awards that are expected to vest over the vesting period. Where granted
share options vest in installments over the vesting period (defined as graded vesting), the Company treats each installment as a separate
share option grant. Share-based compensation expense is recognized over the vesting period, or as specified vesting conditions are satisfied,
and credited to other capital. Any consideration received by the Company in connection with the exercise of stock options is credited
to share capital. Any other capital component of the share-based compensation is transferred to share capital upon the issuance of shares.
The
Company grants deferred share units (“DSUs”) to members of its Board of Directors who are not employees or officers of the
Company. DSUs cannot be redeemed until the holder is no longer a director of the Company and are considered equity-settled instruments.
Under the terms of the DSU agreement, the DSUs vest immediately upon grant. The value attributable to the DSUs is based on the market
value of the share price at the time of grant and share based compensation expense is recognized in general and administrative expenses
in the consolidated statement of comprehensive loss. At the time of redemption, each DSU may be exchanged for one common share of the
Company. Any consideration received by the Company in connection with the exercise of DSUs is credited to share capital. Any other capital
component of the share-based compensation is transferred to share capital upon the issuance of shares.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Revenue
recognition
The
Company generates revenue from license and collaboration agreements with customers (license fees, milestone revenue, royalties), the
provision of development services, the sale of certain active pharmaceutical ingredients (“API”) and semi-finished goods
and finished goods, and from certain supply chain activities, which are comprised largely of oversight or supervisory support services
related to stability studies or development activities carried out with respect to API batch production as specified in underlying contracts
with customers.
The
Company applies the provisions of IFRS 15, Revenue from Contracts with Customers (“IFRS 15”), a single, comprehensive
set of criteria for revenue recognition. IFRS 15 applies to all contracts with customers except for contracts that are within the scope
of other standards. IFRS 15 prescribes a five-step framework through which revenue is recognized when control of promised goods or services
is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for
those goods or services. Goods and services that are determined not to be distinct are combined with other promised goods or services
until a distinct bundle is identified. The Company allocates the transaction price (the amount of consideration to which the Company
expects to be entitled in exchange for the promised goods or services) to each performance obligation and recognizes the associated revenue
when (or as) each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes
all variable consideration to which the Company expects to be entitled, and that estimate is reassessed at the end of each reporting
period. When two or more contracts are entered into with the same customer at or near the same time, the Company evaluates the contracts
to determine whether the contracts should be accounted for as a single arrangement.
The
transaction price is allocated among the performance obligations on a relative standalone selling price basis, and the applicable revenue
recognition criteria are applied to each of the separate performance obligations. Standalone selling prices may be estimated via methods
that include, but are not limited to, an adjusted market assessment approach, an expected cost-plus-margin approach or a residual approach.
Determining the standalone selling price for performance obligations requires significant judgment.
The
Company applies judgment in determining whether a combined performance obligation is satisfied at a point in time or over time, and,
for performance obligations satisfied over time, in concluding upon the appropriate method of measuring progress to be applied for purposes
of recognizing revenue. The Company evaluates the measure of progress each reporting period and, as estimates related to the measure
of progress change, related revenue recognition is adjusted accordingly. Changes in the Company’s estimated measure of progress
are accounted for on a cumulative catch-up basis as a change in accounting estimate and are recorded in the consolidated statement of
comprehensive loss in the period of adjustment.
License
fees
If the license to the Company’s intellectual property is determined
to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable,
upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from
the license. In assessing whether a license is distinct from the other promises, the Company considers whether the collaboration partner
can benefit from the license for its intended purpose without the receipt of the remaining promises, whether the value of the license
is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises and whether it is
separately identifiable from the remaining promises. For licenses that are combined with other promises, the Company utilizes judgment
to assess the nature of the combined performance obligation and whether the license is the predominant promise within the combined performance
obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the
appropriate method of measuring progress for purposes of recognizing revenue.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Development
services
Arrangements
that include a promise for the Company to provide development services are assessed to determine whether the services are capable of
being distinct, are not highly interdependent or do not significantly modify one another, and if so, the services are accounted for as
a separate performance obligation as the services are provided to the customer. Otherwise, when development services are determined not
to be capable of being distinct, such services are added to the performance obligation that includes the underlying license. For development
services that are combined with other promises, the Company applies judgment to assess the nature of the combined performance obligation
to determine whether the combined performance obligation is satisfied over time or at a point in time. The Company utilizes judgment
to determine the appropriate method of measuring progress for purposes of recognizing revenue, which is generally an input measure such
as costs incurred.
Milestone
payments
At
the inception of any contracts with a customer that includes milestone payments, which are oftentimes payable upon the successful achievement
of development or regulatory events, the Company evaluates whether the milestones are considered probable of being reached and estimates
the amount to be included in the transaction price using the most likely amount method. If the Company concludes it is highly probable
that a significant revenue reversal will not occur, the associated milestone payment is included in the transaction price. Milestone
payments that are not within the control of the Company or the licensee, such as regulatory approvals, are generally not considered probable
of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative
stand-alone selling price basis, for which the Company recognizes revenue when (or as) the performance obligations under the contract
are satisfied. At the end of each subsequent reporting period, the Company reassesses the probability of achievement of milestones and
any related constraints, and, if necessary, adjusts the estimate of the overall transaction price on a cumulative catch-up basis.
Royalty
payments
For
arrangements that include sales-based royalties, including milestone payments based on the level of sales, and when the license is deemed
to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur,
or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied.
Product
sales
The
Company recognizes revenue from the sale of certain API and semi-finished goods, including MacrilenTM, upon delivery of such
items to its customer.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Supply
chain revenue
Supply
chain services are contracted with fixed fees and are provided over a period of time. The Company recognizes revenue on a straight-line
basis over time as it best represents the pattern of performance of the services.
While
providing services, the Company incurs certain direct costs for subcontractors and other expenses that are recoverable directly from
its customers. The recoverable amounts of these direct costs are included in the Company’s operating expenses as the Company controls
the services before they are transferred to the customer and acts as a principal in these arrangements.
Contract
costs
The
Company recognizes as an asset the incremental costs of obtaining a contract with a customer if the costs are expected to be recovered,
and any capitalized contract costs are amortized on a systematic basis that is consistent with the transfer to the customer of the goods
or services to which the asset relates. As a practical expedient, the Company recognizes the incremental costs of obtaining a contract
as an expense when incurred if the amortization period of the asset that it otherwise would have recognized is one year or less. To date,
the Company has not incurred any incremental costs of obtaining a contract with a customer.
Contract
modifications
Contract
modifications are defined in IFRS 15 as changes in the scope or price (or both) of a contract that are approved by the parties to the
contract, such as a contract amendment. Contract modifications exist when the parties to a contract approve a modification that either
creates new or changes existing enforceable rights and obligations of the parties to the contract. Depending on facts and circumstances,
the Company accounts for a contract modification in one of the following ways: (a) as a separate contract; (b) as a termination of the
existing contract and a creation of a new contract; or (c) as a combination of the preceding treatments. A contract modification is accounted
for as a separate contract if the scope of the contract increases because of the addition of promised goods or services that are distinct
and the price of the contract increases by an amount of consideration that reflects the Company’s standalone selling prices of
the additional promised goods or services. When a contract modification is not considered a separate contract and the remaining goods
or services are distinct from the goods or services transferred on or before the date of the contract modification, the Company accounts
for the contract modification as a termination of the existing contract and a creation of a new contract. When a contract modification
is not considered a separate contract and the remaining goods or services are not distinct, the Company accounts for the contract modification
as an add-on to the existing contract and as an adjustment to revenue on a cumulative catch-up basis.
Income
tax
Income
tax on profit or loss comprises current and deferred tax. Tax is recognized in profit or loss, except that a change attributable to an
item of income or expense recognized as other comprehensive loss or directly in equity is also recognized directly in other comprehensive
loss or directly in equity. Management periodically evaluates positions taken in tax returns with respect to situations in which applicable
tax regulation is subject to interpretation and establishes provisions where appropriate on the basis of amounts expected to be paid
to the tax authorities.
The
current income tax charge is calculated in accordance with tax rates and laws that have been enacted or substantively enacted by the
reporting date in the countries where the Company’s subsidiaries operate and generate taxable income.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Deferred
income tax is recognized on temporary differences (other than, where applicable, temporary differences associated with unremitted earnings
from foreign subsidiaries and associates, to the extent that the investment is essentially permanent in duration, and temporary differences
associated with the initial recognition of goodwill) arising between the tax bases of assets and liabilities and their carrying amounts
in the consolidated financial statements and on unused tax losses or R&D non-refundable tax credits in the Group. Deferred income
tax is determined using tax rates and laws that have been enacted or substantively enacted by the reporting date.
Deferred
income tax assets are recognized only to the extent that it is probable that future taxable profit will be available against which the
temporary differences can be utilized.
Deferred
income tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets against current tax
liabilities and when the deferred income taxes assets and liabilities relate to income taxes levied by the same taxation authority on
either the same taxable entity or different taxable entities where there is an intention to settle the balances on a net basis.
The
Company provides reserves for potential payments of tax to various tax authorities related to uncertain tax positions and other issues.
Reserves are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filing is more likely
than not to be realized following resolution of any potential contingencies present related to the tax benefit.
Research
and development expenses
Research
costs are expensed as incurred. Development costs are expensed as incurred, except for those that meet the criteria for deferral, in
which case the costs are capitalized and amortized to operations over the estimated period of benefit. No development costs have been
capitalized during any of the periods presented.
Net
loss per share
Basic
net loss per share is calculated using the weighted average number of common shares outstanding during the year.
Diluted
net loss per share is calculated based on the weighted average number of common shares outstanding during the year, plus the effects
of dilutive common share equivalents, such as stock options and warrants. This method requires that diluted net loss per share be calculated
using the treasury stock method, as if all common share equivalents had been exercised at the beginning of the reporting period, or period
of issuance, as the case may be, and that the funds obtained thereby were used to purchase common shares of the Company at the average
trading price of the common shares during the period.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
3. |
Critical accounting estimates and judgments |
The
preparation of consolidated financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions
that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures. Judgments, estimates
and assumptions are based on historical experience, expectations, current trends and other factors that management believes to be relevant
at the time at which the Company’s consolidated financial statements are prepared.
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgments in order to ensure that the
consolidated financial statements are presented fairly and in accordance with IFRS. Revisions to accounting estimates are recognized
in the period in which the estimates are revised and in any future periods affected.
Critical
accounting estimates and assumptions are those that have a significant risk of causing material adjustment and are often applied to matters
or outcomes that are inherently uncertain and subject to change. As such, management cautions that future events often vary from forecasts
and expectations and that estimates routinely require adjustment.
The
following discusses the most significant accounting estimates and assumptions that the Company has made in the preparation of the consolidated
financial statements.
Accounting
for a contract modification
The
Novo Amendment, as defined and discussed in note 5 – License, supply and distribution arrangements, and which was determined to
be a modification pursuant to the provisions of IFRS 15, required management to apply significant judgments, including: assessment of
any increases to the scope of the license agreement; assessment of whether the remaining goods or services are distinct from goods or
services transferred before the modification; and assessment as to whether a portion of the changes in the transaction price was attributable
to the amount of variable consideration promised before the modification. Any changes in the judgments or assumptions applied to account
for this agreement could have a significant impact on the Company’s revenue and deferred revenue.
License and collaboration arrangements
with multiple elements
The Company enters into licensing and
supply agreements related to the licensing, development, supply and distribution for macimorelin in various territories. Each agreement
may contain specific terms or clauses that require careful analysis by management under IFRS 15 in order to ensure the appropriate accounting
treatment is reached. The agreements may include non-refundable upfront payments and licensing fees, the provision of development services,
pre- and post-commercialization milestone payments, royalties on future product sales derived from such license agreements, and supply
arrangements. Management analyzes each agreement and applies significant judgment to determine whether contracts entered into at or near
the same time should be accounted for as a single arrangement, whether all parts of the contract are scoped within IFRS 15, to identify
all performance obligations, determine whether a performance obligation is distinct or should be combined with other promised goods and
services, determine and allocate the transaction price on a relative stand-alone selling price basis, determine whether a combined performance
obligation is satisfied at a point in time or over time, and, for performance obligations satisfied over time, in concluding upon the
appropriate method of measuring progress to be applied for purposes of recognizing revenue. Any changes in the judgments or assumptions
applied can give rise to a significant impact on the Company’s revenues and deferred revenues
Impairment
of goodwill
The
annual impairment assessment related to goodwill requires management to estimate the recoverable amount, which has been determined using
fair value less cost of disposal. The Company has a single cash generating unit and reportable segment, and management monitors goodwill
based on an overall entity basis. The carrying amount of its consolidated net assets is compared to its overall market capitalization
less estimated cost of disposal. Based on this calculation, including a control premium, management determined that goodwill was not
impaired. Future events could cause the assumptions utilized in the impairment tests to change, resulting in a potentially adverse effect
on the Company’s future results due to increased impairment charges.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Employee
future benefits
The
determination of expenses and obligations associated with employee future benefits requires the use of assumptions, such as the discount
rate to measure obligations, rate of pension benefit increases, the projected age of employees upon retirement and the expected rate
of future compensation. Because the determination of the costs and obligations associated with employee future benefits requires the
use of various assumptions, there is measurement uncertainty inherent in the actuarial valuation process. Actual results will differ
from results that are estimated based on the aforementioned assumptions. Additional information is included in note 18 - Employee future
benefits.
Research
and development accrual
As
part of the process of preparing our financial statements, we are required to estimate accrued expenses including those pertaining to
our research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel
to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred
for the service when we have not yet been invoiced or otherwise notified of the actual cost. If the actual timing of the performance
of services or the level of effort varies from our estimate, we adjust the accrued or prepaid expense balance accordingly. Although the
Company does not expect estimates to be materially different from amounts actually incurred, if those estimates of the status and timing
of services performed differ from the actual status and timing of services performed, the Company may report amounts that are too high
or too low in any particular period.
4. |
Recent accounting pronouncements |
IFRS
Pronouncements issued but not yet effective
(a)
IAS 37, Provisions, Contingent Liabilities and Contingent Assets (“IAS 37”)
The
amendment to IAS 37 clarifies the meaning of costs to fulfil a contract and that before a separate provision for an onerous contract
is established, an entity recognizes any impairment loss that has occurred on assets used in fulfilling the contract, rather than on
assets dedicated to the contract. This amendment will be effective for annual periods beginning on or after January 1, 2022. The Company
is currently evaluating this guidance and the impacts that the amendments may have on the Company’s consolidated financial statements.
5. |
License, supply and distribution arrangements |
License
and supply agreements for Macrilen™ - United States and Canada
On
January 16, 2018, the Company, through AEZS Germany, entered into License Agreement with Strongbridge Ireland Limited (“Strongbridge”)
to carry out development, manufacturing, registration, regulatory and supply chain services for the commercialization of Macrilen™
(macimorelin) in the U.S. and Canada, which provides for (i) a right to use license relating to the adult indication (the “Adult
Indication”); (ii) a license for a future FDA-approved pediatric indication (the “Pediatric Indication”); (iii) the
licensee to fund 70% of the costs of a pediatric clinical trial submitted for approval to the EMA and FDA to be run by the Company with
oversight from a joint steering committee (the “PIP”); and (iv) for an Interim Supply Arrangement. In January 2018, the Company
received a cash payment of $24,000 from Strongbridge and on July 23, 2018, Strongbridge launched product sales of Macrilen™ (macimorelin)
in the U.S. The Company is also entitled to receive a milestone payment of $5,000 upon FDA approval of the Pediatric Indication. Effective
December 19, 2018, Strongbridge sold the entity which owned the License Agreement for the U.S. and Canadian rights to Macrilen™
(macimorelin) to Novo. In 2019, the Interim Supply Arrangement was concluded and Novo contracted AEZS Germany to provide supply chain
services for the manufacture of Macrilen™ (macimorelin).
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
On
November 16, 2020, the Company, through AEZS Germany, entered into an amendment (the “Novo Amendment”) of its existing License
Agreement with Novo related to the development and commercialization of macimorelin.
Under
the Novo Amendment, Aeterna continues to retain all rights to macimorelin outside of the U.S. and Canada but Novo agreed to make an upfront
payment to Aeterna of $6,109 (€5,000), which the Company received in December 2020. Under the Novo Amendment, the royalty payment
Aeterna receives on sales in the U.S. and Canada was reduced from 15% to 8.5% for annual net sales up to U.S.$40 million and returns
to 15% or more for annual net sales of macimorelin over U.S.$40 million. Additionally, the $5,000 variable payment owing to Aeterna by
Novo, upon FDA approval of the pediatric indication, was waived. Under the Novo Amendment, Novo and Aeterna agreed that solely Aeterna
will conduct the pivotal Study P02 in partnership with a contract research organization (“CRO”). Given the transfer of development
activities to Aeterna, the percentage of Study P02 clinical trial costs that Novo is required to reimburse to Aeterna was adjusted from
70% to 100% of costs up to €9,000 (approximately $10,980). Any additional external jointly approved Study P02 trial costs incurred
over €9,000 will be shared equally between Novo and Aeterna. In addition, certain changes to rights and responsibilities of the
joint steering committee were made.
Under
the amended terms, Novo was also granted co-ownership of the U.S. and Canadian patents and trademarks owned by Aeterna on macimorelin
but will be required to transfer co-ownership in those patents back to Aeterna on the occurrence of certain termination events.
Management
has determined that the modification that grants co-ownership of the U.S. and Canadian patents and trademarks that were previously licensed
by the Company to Novo is not a distinct performance obligation as the related benefits are highly interdependent and interrelated with
the licensed indications granted under the existing license contract prior to the modification.
In
addition, upon regulatory approval of macimorelin in the U.S. for the diagnosis of CGHD, if Novo determines not to commercialize macimorelin
in Canada, then Aeterna has the option to exclusively license rights to macimorelin in Canada (but not in U.S.) to a third party. The
Amendment also confirms that Aeterna has the right to use the results from Study P02, if successful, to support Aeterna seeking regulatory
approval and ongoing efforts to seek partnering opportunities for macimorelin in other regions outside of the two countries licensed
to Novo, the U.S. and Canada.
Analysis
prior to modification
At
contract inception, upon analysis of the total discounted cash flows of both the $24,000 payment and the $5,000 payment upon FDA approval
of the Pediatric Indication, the Company determined that 84% of the future revenue streams would be derived from the Adult Indication
and 16% from the Pediatric Indication. On a relative fair value basis, the Company had allocated the transaction price to the performance
obligations resulting in $23,600 being allocated to the Adult Indication and being recognized as license fee revenue in the consolidated
statement of comprehensive loss for the year ended, December 31, 2018, and $400 being allocated to the Pediatric Indication, which was
recognized as deferred revenue on the consolidated statement of financial position and amortized on a straight-line basis beginning January
2018, over a period of 5.4 years, into the consolidated statements of comprehensive loss.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Under
the License Agreement, the Company considered the funding arrangement under the PIP to be a collaboration arrangement under IFRS 11 and
has accounted for the invoicing as a reduction of costs incurred. During 2020, the Company invoiced its licensee $1,099 (2019 - $979)
as its share of the costs incurred by the Company.
Analysis
post modification
On
November 16, 2020, the Company announced that it had entered into the Novo Amendment of its existing License Agreement and received an
upfront payment of $6,109
(€5,000)
in December 2020. Management determined that the remaining performance obligation under the contract which provides the customer with
the license of a future FDA approved Pediatric Indication is a distinct performance obligation before and after the modification. Accordingly,
the Company accounted for the modification to the License Agreement as an adjustment to the existing License Agreement with Novo, on
a prospective basis. The portion of the changes in the transaction price that was attributable to the change in royalty rate was allocated
to both the Adult Indication and the Pediatric Indication. Based on the change in future royalty rates, the Company determined
that $550
of the additional upfront payment should be allocated
to the Adult Indication. Accordingly, the Company allocated $550
(€470)
to the Adult Indication which was recognized in revenues for the year ended December 31, 2020 and deferred $5,559
(€4,530).
As
required per IFRS 11, given changes in facts and circumstances with respect to the development activities associated with the pediatric
indication—namely, the substantive changes to rights and responsibilities granted to Novo pursuant to the Novo Amendment—management
reassessed whether the classification of those activities should change. Management concluded that the parties to the Novo Amendment
no longer share joint control of the related activities. As such, the Pediatric Indication development activities are no longer accounted
for under IFRS 11, and the incremental performance obligation associated with the Pediatric Indication development services has been
combined with the pediatric license for revenue recognition purposes. No other additional performance obligations were identified in
the Novo Amendment.
Based
on the preceding analysis, management determined that the total modified transaction price was $5,754
(€4.7
million), which is comprised of $195
(€0.2
million) pre-Novo Amendment unamortized pediatric
license fee and $5,559
(€4.5
million) post-Novo Amendment Pediatric Indication
and has been allocated to the remaining combined performance obligation. Revenue associated with this performance obligation is being
recognized as pediatric development services using a cost-to-cost measure of progress method. The transfer of control to Novo occurs
over time, and as such, in management’s judgment, this input method is the best measure of progress towards satisfying the performance
obligation and reflects a faithful depiction of the transfer of goods and services. As of December 31, 2021, management expects that
the remaining performance obligation will be recognized through December 31, 2022. Management reevaluates the transaction price
at the end of each reporting period or as changes in circumstances occur and adjusts the transaction price and the timing of recognition
thereof as necessary.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Supply
Chain Arrangement
The
Company agreed, in the Interim Supply Arrangement to the License Agreement, to supply ingredients for the manufacture of Macrilen™
(macimorelin) during an interim period at a price that is set ‘at cost’ without any profit margin. The Company believes the
stand-alone selling price of the manufacturing ingredients to be their cost, as that approximates the amount at which Novo would be able
to procure those same goods with other suppliers. In November 2019, Novo contracted with AEZS Germany, to provide supply chain services
including provision of supervision of stability studies (support services) as well as API batch production and delivery of certain API
and semi-finished goods.
License
and supply agreements for macimorelin - European Union and United Kingdom
Background
On
December 7, 2020, the Company entered into an exclusive licensing agreement with Consilient Health Limited (“CH”) for the
commercialization of macimorelin (the “Licensed Product”) in the European Economic Area and the United Kingdom (the “CH
License Agreement”).
Under
the terms of the CH License Agreement, CH agreed to make a non-refundable, non-creditable upfront payment to the Company of $1,209
(€1.0
million), which the Company received in January 2021. The Company also is eligible to receive additional consideration, including
regulatory milestones related to agreed-upon pricing and reimbursement parameters; net sales milestones; and royalties, ranging from
10%-20% of net sales of macimorelin, subject to reduction in certain cases, or sublicense income recorded by CH. Also on December 7,
2020, the Company and CH entered into an exclusive supply agreement, pursuant to which the Company agreed to provide the Licensed
Product to CH, with such Licensed Product to be manufactured by third-party manufacturers for a period of ten years, subject to
renewal (the “CH Supply Agreement”).
The
total transaction price associated with the CH Agreement is $1,209 (€1.0 million), which consists of the non-refundable, non-creditable
upfront payment, discussed above. At the inception of the contract, all other contractual consideration to which the Company may be entitled
represents variable consideration, including the regulatory milestones, which were determined to be zero, based on management’s
estimate of the most likely amount, given that the achievement of the underlying milestones is
uncertain and highly susceptible to factors outside of the Company’s control.
The
Company allocated the transaction price to the two combined performance obligation of the license agreement and the supply agreement
for the adult and pediatric indication, using the application of an adjusted market assessment approach. Revenue will be recognized over
time using an outputs method based on units of Licensed Product supplied to CH. The total units that the Company expects to supply to
CH pursuant to the CH Agreement is an estimate, based on current projections and anticipated market demand, and therefore will be a significant
judgment that will be relied upon when using the outputs method to recognize revenue.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
In
December 2021, the Department of Health and Social Care in the United Kingdom approved a list price which triggered a $226 (€0.2
million) pricing milestone payment, which was allocated to the Adult license performance obligation and deferred to the consolidated
statement of financial position.
The
aggregate amount of the transaction price allocated to the Company’s unsatisfied or partially unsatisfied performance obligations
under the CH Agreement was $1,358 (€1.2 million) as of December 31, 2021. The Company expects to recognize the balance of the relevant
deferred revenue over the remaining period of ten years, subject to extension based on the outcome of the ongoing clinical development
related to the Pediatric Indication and related patent application initiatives.
For
the year ended December 31, 2021, the Company recognized $nil as license fee revenue associated with the CH Agreement.
License
and supply agreements for macimorelin - Korea
The
Company and NK Meditech Limited (“NK”) entered into a licensing agreement, effective November 30, 2021 and pursuant to which
the Company granted to NK the exclusive right to commercialize (including marketing, selling and offering to sell) macimorelin in the
Republic of Korea (the “ROK”) and as applicable, in the Democratic People’s Republic of Korea (“DPRK”)
to the extent NK is allowed to use the aforementioned licensed rights in the latter (“NK License Agreement”).
Under
the terms of the NK License Agreement, NK agreed to make a non-refundable, non-creditable upfront payment to the Company of $136
(€0.1
million), which the Company received in December
2021. The Company also is eligible to receive additional consideration, including a regulatory milestone related to the approval of macimorelin
in the Pediatric Indication in the ROK and/or DPRK. Additionally, NK has agreed to pay AEZS royalties of 12% of any sublicense income
(i.e., royalties, upfront payments, license or option fees, lump sum payments, equity securities, milestone payments or other
non-cash consideration) that may be received by NK from any future sublicensees (“Sublicense Income”).
Also,
effective November 30, 2021, the Company and NK entered into an exclusive supply agreement, pursuant to which the Company agreed to provide
macimorelin to NK for a period of ten years, subject to renewal (the “NK Supply Agreement”).
Management
determined that the total transaction price associated with the NK License Agreement was $136
(€0.1
million), which consists of the upfront payment,
discussed above, that was received by the Company in 2021. The Company allocated the $136
(€0.1
million) transaction price to the single combined
performance using an outputs method based on units of macimorelin supplied to NK over a 10-year period.
Distribution
agreement for macimorelin - Israel and the Palestinian Authority
In
June 2020, the Company entered into an exclusive distribution and quality agreement with MegaPharm Ltd. (“MegaPharm”) for
the commercialization in Israel and in the Palestinian Authority of MacrilenTM, to be used in the diagnosis of patients with
adult growth hormone deficiency and in clinical development for the diagnosis of pediatric growth hormone deficiency (the “MegaPharm
Agreement”). Under the terms of the MegaPharm Agreement, MegaPharm will be responsible for obtaining registration to market MacrilenTM
in Israel and the Palestinian Authority, while the Company will be responsible for manufacturing, product supply, quality assurance
and control, regulatory support, and maintenance of the relevant intellectual property. In June 2021 MegaPharm filed an application to
the Ministry of Health of Israel for regulatory approval of macimorelin in Israel and, as of December 31, 2021, there have been no products
supplied under this agreement.
Summary
of revenue recognized, deferred revenue and contract asset balances associated with license, supply and distribution arrangements
The
following table provides a summary of deferred revenue balances for the Novo Amendment, CH Agreement and NK License Agreement as of December
31:
Summary
of Deferred Revenue
| |
2021 | |
| |
Current | | |
Non-Current | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Novo Amendment | |
| 4,791 | | |
| 23 | | |
| 4,814 | |
CH Agreement | |
| 24 | | |
| 1,334 | | |
| 1,358 | |
NK License Agreement | |
| — | | |
| 136 | | |
| 136 | |
Total | |
| 4,815 | | |
| 1,493 | | |
| 6,308 | |
| |
2020 | |
| |
Current | | |
Non-Current | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Novo Amendment | |
| 2,193 | | |
| 3,289 | | |
| 5,482 | |
Total | |
| 2,193 | | |
| 3,289 | | |
| 5,482 | |
The following table provides a summary
of revenue recognized for the Strongbridge agreement and Novo Amendment:
Summary
of Products Supplied Under Agreement
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
| |
| $ | | |
| $ | | |
| $ | |
License fee associated with the Strongbridge Agreement | |
| — | | |
| 68 | | |
| 74 | |
License fee associated with the Novo Amendment (of which $1,670
(2020 - $264
and 2019 - $nil)
in deferred revenue was recognized) | |
| 1,670 | | |
| 843 | | |
| — | |
Development services associated with Novo Amendment | |
| 3,337 | | |
| — | | |
| — | |
Product sales associated with Novo Supply Agreement (of which $nil (2020 - $852 and 2019 - $nil) in deferred revenue was recognized for prepayments received from Novo) | |
| — | | |
| 2,370 | | |
| 129 | |
Royalties associated with the Strongbridge Agreement | |
| — | | |
| 56 | | |
| 45 | |
Royalties associated with the Novo Amendment | |
| 68 | | |
| 11 | | |
| — | |
Supply chain revenue associated with the Novo Supply Agreement (of which $nil (2020 - $67 and 2019 - $nil) in deferred revenue was recognized upon sale of Macrilen™ to Novo) | |
| 185 | | |
| 304 | | |
| 284 | |
Total | |
| 5,260 | | |
| 3,652 | | |
| 532 | |
As
of December 31, 2021, the Company had $132 in contract assets associated with the Novo Amendment which is presented in other receivables
in the Company’s consolidated statement of financial position (note 7).
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
6. |
Cash and cash equivalents |
Summary of Cash and Cash Equivalents
| |
2021 | | |
2020 | |
| |
December 31, | |
| |
2021 | | |
2020 | |
| |
| $ | | |
| $ | |
Cash on hand and balances with banks | |
| 55,600 | | |
| 23,920 | |
Interest-bearing deposits with maturities of three months or less | |
| 9,700 | | |
| 351 | |
Cash and cash equivalents | |
| 65,300 | | |
| 24,271 | |
7. |
Trade and other receivables |
Schedule of Trade and Other Receivables
| |
2021 | | |
2020 | |
| |
December 31, | |
| |
2021 | | |
2020 | |
| |
| $ | | |
| $ | |
Trade accounts receivable (net of expected credit losses of $55 (2020 - $55)) | |
| 877 | | |
| 1,190 | |
Value added tax | |
| 372 | | |
| 468 | |
Other receivables | |
| 65 | | |
| 23 | |
Trade and other receivables | |
| 1,314 | | |
| 1,681 | |
See
also note 24 - Financial instruments and financial risk management for discussion of credit losses.
Summary of Inventory
| |
2021 | | |
2020 | |
| |
December 31, | |
| |
2021 | | |
2020 | |
| |
| $ | | |
| $ | |
Work in process | |
| 73 | | |
| 21 | |
Inventory | |
| 73 | | |
| 21 | |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
Company recognized $nil of inventory costs and $nil as impairment in inventory in the consolidated statement of comprehensive loss for
the year ended December 31, 2021 (2020 - $1,980 and $131, respectively and 2019 - $101 and $106, respectively).
9. |
Prepaid expenses and other current assets |
Summary of Prepaid Expenses and Other Current Assets
| |
2021 | | |
2020 | |
| |
December 31, | |
| |
2021 | | |
2020 | |
| |
| $ | | |
| $ | |
Prepaid insurance | |
| 421 | | |
| 1,021 | |
Prepaid research and development | |
| 1,329 | | |
| — | |
Other | |
| 22 | | |
| 19 | |
Prepaid expenses and
other current assets | |
| 1,772 | | |
| 1,040 | |
10. |
Restricted cash equivalents |
The
Company had restricted cash equivalents amounting to $335 at December 31, 2021 (2020 - $338). These balances consist of certificates
of deposit that are used as collateral for corporate credit cards and leases.
11. |
Property, plant and equipment |
Components
of the Company’s property, plant and equipment are summarized below.
Summary of Property, Plant and Equipment
| |
Equipment | | |
Furniture and fixtures | | |
Computer equipment | | |
Leasehold improvements | | |
Total | |
| |
Cost | |
| |
Equipment | | |
Furniture and fixtures | | |
Computer equipment | | |
Leasehold improvements | | |
Total | |
| |
$ | | |
$ | | |
$ | | |
$ | | |
$ | |
At January 1, 2020 | |
| 422 | | |
| 7 | | |
| 314 | | |
| 34 | | |
| 777 | |
Property, plant and equipment, Cost Beginning | |
| 422 | | |
| 7 | | |
| 314 | | |
| 34 | | |
| 777 | |
Disposals / Retirements | |
| (245 | ) | |
| (7 | ) | |
| (3 | ) | |
| (38 | ) | |
| (293 | ) |
Impact of foreign exchange rate changes | |
| 38 | | |
| — | | |
| 24 | | |
| 4 | | |
| 66 | |
At December 31, 2020 | |
| 215 | | |
| — | | |
| 335 | | |
| — | | |
| 550 | |
Additions | |
| 6 | | |
| — | | |
| 24 | | |
| — | | |
| 30 | |
Disposals / Retirements | |
| (5 | ) | |
| — | | |
| (69 | ) | |
| — | | |
| (74 | ) |
Impact of foreign exchange rate changes | |
| (17 | ) | |
| — | | |
| (22 | ) | |
| — | | |
| (39 | ) |
At December 31, 2021 | |
| 199 | | |
| — | | |
| 268 | | |
| — | | |
| 467 | |
Property, plant and equipment, Cost Ending | |
| 199 | | |
| — | | |
| 268 | | |
| — | | |
| 467 | |
| |
| Equipment | | |
| Furniture and fixtures | | |
| Computer equipment | | |
| Leasehold improvements | | |
| Total | |
| |
| Accumulated
Depreciation
| | |
| |
| Equipment | | |
| Furniture and fixtures | | |
| Computer equipment | | |
| Leasehold improvements | | |
| Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At January 1, 2020 | |
| 400 | | |
| 7 | | |
| 307 | | |
| 28 | | |
| 742 | |
Property, plant and equipment, Accumulated depreciation Beginning | |
| 400 | | |
| 7 | | |
| 307 | | |
| 28 | | |
| 742 | |
Disposals / Retirements | |
| (247 | ) | |
| (7 | ) | |
| (3 | ) | |
| (38 | ) | |
| (295 | ) |
Depreciation expense | |
| 6 | | |
| — | | |
| 3 | | |
| — | | |
| 9 | |
Impact of foreign exchange rate changes | |
| 40 | | |
| — | | |
| 22 | | |
| 10 | | |
| 72 | |
At December 31, 2020 | |
| 199 | | |
| — | | |
| 329 | | |
| — | | |
| 528 | |
Disposals / Retirements | |
| (5 | ) | |
| — | | |
| (69 | ) | |
| — | | |
| (74 | ) |
Depreciation expense | |
| 4 | | |
| — | | |
| 5 | | |
| — | | |
| 9 | |
Impact of foreign exchange rate changes | |
| (17 | ) | |
| — | | |
| (21 | ) | |
| — | | |
| (38 | ) |
At December 31, 2021 | |
| 181 | | |
| — | | |
| 244 | | |
| — | | |
| 425 | |
Property, plant and equipment, Accumulated depreciation Ending | |
| 181 | | |
| — | | |
| 244 | | |
| — | | |
| 425 | |
| |
| Carrying amount | |
| |
| Equipment | | |
| Furniture and fixtures | | |
| Computer equipment | | |
| Leasehold improvements | | |
| Total | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
At December 31, 2020 | |
| 16 | | |
| — | | |
| 6 | | |
| — | | |
| 22 | |
At December 31, 2021 | |
| 18 | | |
| — | | |
| 24 | | |
| — | | |
| 42 | |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Schedule of Right of Use Assets
| |
| |
Vehicles and equipment | | |
|
| |
$ | | |
$ | | |
$ | |
Cost | |
| | | |
| | | |
| | |
At January 1, 2020 | |
| 757 | | |
| 106 | | |
| 863 | |
Modification of building lease | |
| (259 | ) | |
| — | | |
| (259 | ) |
Additions | |
| — | | |
| 7 | | |
| 7 | |
Disposals | |
| — | | |
| (21 | ) | |
| (21 | ) |
Impact of foreign exchange rate changes | |
| 48 | | |
| 2 | | |
| 50 | |
At December 31, 2020 | |
| 546 | | |
| 94 | | |
| 640 | |
Additions | |
| 16 | | |
| — | | |
| 16 | |
Modification of building lease | |
| 109 | | |
| — | | |
| 109 | |
Impact of foreign exchange rate changes | |
| (48 | ) | |
| (7 | ) | |
| (55 | ) |
At December 31, 2021 | |
| 623 | | |
| 87 | | |
| 710 | |
|
|
|
Vehicles
and equipment |
|
|
|
$ |
|
$ |
|
$ |
Accumulated
Depreciation |
|
|
|
|
|
|
At
January 1, 2020 |
|
242 |
|
39 |
|
281 |
Disposals |
|
— |
|
(21) |
|
(21) |
Depreciation |
|
180 |
|
23 |
|
203 |
Impact
of foreign exchange rate changes |
|
15 |
|
5 |
|
20 |
At
December 31, 2020 |
|
437 |
|
46 |
|
483 |
Depreciation |
|
94 |
|
26 |
|
120 |
Impact
of foreign exchange rate changes |
|
(38) |
|
(5) |
|
(43) |
At
December 31, 2021 |
|
493 |
|
67 |
|
560 |
| |
Building | | |
Vehicles and equipment | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Carrying amount | |
| | | |
| | | |
| | |
As of December 31, 2020 | |
| | |
| 48 | | |
| |
As of December 31, 2021 | |
| | |
| 20 | | |
| |
Effective
August 25, 2021, the Company and its landlord mutually agreed to a one-year extension to its existing building lease agreement for its
German subsidiary, continuing such terms until March 31, 2023, resulting in a modification being recorded to the building right of use
asset in the amount of $109. Upon the renegotiation of the building lease agreement completed on April 30, 2020, a modification was recorded
to the building right of use asset in the amount of $259, representing the reduction in the square footage leased from the landlord.
Also see note 17 - Lease liabilities.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
13. |
Identifiable intangible assets |
Changes
in the carrying value of the Company’s identifiable intangible assets are summarized below.
Summary of Identifiable Intangible Assets with Finite Useful Lives
| |
Year ended December 31, 2021 | | |
Year ended December 31, 2020 | |
| |
Cost | | |
Accumulated amortization | | |
Carrying value | | |
Cost | | |
Accumulated amortization | | |
Carrying value | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Balances – Beginning of the year | |
| 35,020 | | |
| (34,961 | ) | |
| 59 | | |
| 31,422 | | |
| (31,382 | ) | |
| 40 | |
Additions | |
| 609 | | |
| — | | |
| 609 | | |
| 34 | | |
| — | | |
| 34 | |
Amortization expense | |
| — | | |
| (16 | ) | |
| (16 | ) | |
| — | | |
| (20 | ) | |
| (20 | ) |
Impact of foreign exchange rate changes | |
| (3,218 | ) | |
| 3,191 | | |
| (27 | ) | |
| 3,564 | | |
| (3,559 | ) | |
| 5 | |
Balances – End of the year | |
| 32,411 | | |
| (31,786 | ) | |
| 625 | | |
| 35,020 | | |
| (34,961 | ) | |
| 59 | |
During
2021, the Company recorded additions of $609, for separately identified intangibles related to upfront payments under certain license
agreements with the University of Wuerzburg €400 ($471) and the University of Sheffield £100 ($138). These intangible assets
were not subject to amortization in the year ended December 31, 2021 as they are not ready for their intended use. Amortization of intangible
assets with finite lives of $16 (2020 - $20 and 2019 - $20) is presented in research and development expenses.
Cetrotide
On
August 10, 2021, the Company entered into a trademark maintenance and assignment option agreement with ARES Trading SA, a subsidiary
of Merck KGaA (“Merck”), with respect to the trademarks owned by the Company on Cetrotide® (cetrorelix acetate for injection),
a luteinizing hormone-releasing hormone antagonist approved for therapeutic use as part of in vitro fertilization programs in women undergoing
infertility treatment (the “Cetrotide Agreement”). The Company had transferred all Cetrotide activities to Merck in 2013
via a license and supply agreement (“LSA”).
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Pursuant
to the Cetrotide Agreement, the Company has granted to Merck the exclusive option to acquire any and all rights in the Cetrotide trademarks
at the end of the term of the LSA (the “Option”), which currently is May 2029 (the “Transfer Date”), when, as
agreed, the Company will convey and assign to Merck all rights and interest in, as well as title to, the Cetrotide trademarks. The transfer
of the trademarks on the Transfer Date shall constitute a sale, after which the Company will no longer have any ownership in or obligations
related to the Cetrotide trademarks.
As
consideration for having been granted the Option, Merck has agreed to pay the Company a total of $566 (€0.5 million) a portion of
which is to be calculated as a reimbursement of all internal and external trademark fees incurred by the Company for all years beginning
with 2019 until the Transfer Date. If the Company is not able to transfer the trademarks to Merck on the Transfer Date, all consideration
paid by Merck to the Company through the Transfer Date shall be refunded to Merck, and all rights associated with the Trademarks shall
revert back to the Company.
The
carrying value of the trademarks underlying Cetrotide is $nil and the Company received proceeds of $98 through December 31, 2021. Any
proceeds that are received pursuant to the Cetrotide Agreement have been or will be recorded as a deferred gain in the Company’s
consolidated statement of financial position. The Company will recognize the entirety of the gain on the Transfer Date to the extent
that the transfer is successful.
Summary of Change in Carrying Value of Goodwill
| |
Cost | | |
Accumulated impairment loss | | |
Carrying amount | |
| |
$ | | |
$ | | |
$ | |
Balances at January 1, 2020 | |
| 8,050 | | |
| — | | |
| 8,050 | |
Impact of foreign exchange rate changes | |
| 765 | | |
| — | | |
| 765 | |
Balances at December 31, 2020 | |
| 8,815 | | |
| — | | |
| 8,815 | |
Impact of foreign exchange rate changes | |
| (685 | ) | |
| — | | |
| (685 | ) |
Balances at December 31, 2021 | |
| 8,130 | | |
| — | | |
| 8,130 | |
Management’s
evaluation of impairment in goodwill is based on fair value less costs of disposal based on the Company’s market capitalization
at December 31, 2021, including a control premium, less estimated cost of disposal of approximately $1,774. There was no impairment assessed
at December 31, 2021.
15. |
Payables and accrued liabilities |
Schedule of Payables and Accrued Liabilities
| |
2021 | | |
2020 | |
| |
December 31, | |
| |
2021 | | |
2020 | |
| |
| $ | | |
| $ | |
Trade accounts payable | |
| 934 | | |
| 1,187 | |
Accrued research and development costs | |
| 531 | | |
| 23 | |
Salaries, employment taxes and benefits | |
| 596 | | |
| 474 | |
Other accrued liabilities | |
| 611 | | |
| 515 | |
Payables and accrued
liabilities | |
| 2,672 | | |
| 2,199 | |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Schedule of Changes in Provisions for Onerous Contracts
| |
Cetrotide onerous contracts | | |
German restructuring: severance | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Balance at January 1, 2020 | |
| 396 | | |
| 330 | | |
| 726 | |
Utilization of provision | |
| (93 | ) | |
| (323 | ) | |
| (416 | ) |
Change in the provision | |
| 33 | | |
| — | | |
| 33 | |
Unwinding of discount and impact of foreign exchange rate changes | |
| 35 | | |
| (7 | ) | |
| 28 | |
Balance at December 31, 2020 | |
| 371 | | |
| — | | |
| 371 | |
Utilization of provision | |
| (90 | ) | |
| — | | |
| (90 | ) |
Change in the provision | |
| 23 | | |
| — | | |
| 23 | |
Unwinding of discount and impact of foreign exchange rate changes | |
| (27 | ) | |
| — | | |
| (27 | ) |
Balance at December 31, 2021 | |
| 277 | | |
| — | | |
| 277 | |
Less: current portion | |
| 34 | | |
| — | | |
| 34 | |
Non-current portion | |
| 243 | | |
| — | | |
| 243 | |
In
2013, the Company recognized a provision for certain non-cancellable contracts related to the Cetrotide activities, discussed in note
13 – Identifiable intangible assets, that were deemed onerous. The provisions for onerous contracts represent the present value
of estimated unavoidable future royalty and patent costs associated with the intellectual property underlying Cetrotide.
On
June 6, 2019, the Company announced that it was reducing the size of its German workforce to more closely reflect the Company’s
ongoing commercial activities. This restructuring was completed on January 31, 2020.
Schedule of Operating Lease Liabilities
| |
Years Ended December 31, | |
| |
2021 | | |
2020 | |
| |
| $ | | |
| $ | |
Balance – Beginning of period | |
| 184 | | |
| 903 | |
Additions | |
| 15 | | |
| 7 | |
Interest paid as charged to comprehensive loss as other finance costs | |
| (7 | ) | |
| (19 | ) |
Payment against lease liabilities | |
| (127 | ) | |
| (265 | ) |
Modification of lease liability | |
| 103 | | |
| (463 | ) |
Impact of foreign exchange rate changes | |
| (7 | ) | |
| 21 | |
Balance – End of period | |
| 161 | | |
| 184 | |
Current lease liabilities | |
| 130 | | |
| 135 | |
Non-current lease liabilities | |
| 31 | | |
| 49 | |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Effective
March 31, 2020, the Company and its landlord mutually agreed to modify its existing building lease agreement for its German subsidiary,
extended the lease term for its portion of the reduced space from April 30, 2021 to March 31, 2022 and retained one sub-lessee until
April 30, 2021. On May 5, 2020, the sub-lessee terminated its lease with the Company effective April 30, 2020. Concurrent with this termination,
the Company was able to renegotiate a further reduction in leased square footage with the landlord, which resulted in a lease modification
and a resulting gain of $34 which was recorded in the consolidated statement of comprehensive loss. Effective August 25, 2021, the Company
and its landlord mutually agreed to a one-year extension to its existing building lease agreement for its German subsidiary, continuing
such terms until March 31, 2023, resulting in a lease modification and a resulting gain of $nil (2020 - $34) which was recorded in the
consolidated statement of comprehensive loss.
Future
lease payments as of December 31, 2021 are as follows:
Summary of Maturity Analysis of Operating Lease Liabilities
|
|
$ |
|
Less
than 1 year |
|
|
130 |
|
1
– 3 years |
|
|
31 |
|
Total |
|
|
161 |
|
18. |
Employee future benefits |
AEZS Germany provides unfunded and
partially funded defined benefit multi-employer pension plans, namely the DUPK pension plan and the RUK 1990 and 2006 pension plans,
(the “Pension Benefit Plans”) and unfunded post-employment benefit plans for certain groups of employees. Provisions for
pension obligations are established for benefits payable in the form of retirement, disability and surviving dependent pensions. The
Company also provides a defined contribution plans to some of its employees.
The
Pension Benefit Plans are final salary pension plans, which provide benefits to members (or to their surviving dependents) in the form
of a guaranteed level of pension payable for life. The level of benefits provided depends on the member’s length of service and
on the member’s base salary in the final years leading up to retirement. Current pensions vary in accordance with applicable statutory
requirements, which foresee an adjustment every three years on an individual basis that is based on inflationary increases or in relation
to salaries of comparable groups of active employees in the Company. Generally, the Company has not authorized actual pension increases,
given the economic situation of the Company, and any legally required increases have been funded from the related pension surpluses.
In 2020, the Company became responsible for pension increases for one of its Pension Benefit Plans and, in 2021, the Company became additionally
responsible for pension increases for two of its Pension Benefit Plans.
An
increase may be denied by the Company if the Company’s financial situation does not allow for an increase in pensions. As most
German pension plans grant lifelong pension benefits, rising life expectancy could increase the Company’s benefit obligation. These
plans are fully or partially unfunded and the Company meets benefit payment obligations as they fall due.
In
the past, certain Pension Benefit Plans were accounted for as defined contribution plans as sufficient information was not available
for the Company to account for its proportionate share of the defined benefit obligation, plan assets and cost associated with such Pension
Benefit Plans. During 2021, additional information became available to the Company, which began to account for its proportionate share
of the defined benefit obligation and plan assets amounting to $16,137 and $11,963, respectively, which amounts were recorded through
other comprehensive income.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
change in the Company’s accrued benefit obligations associated with the Employee future obligation is summarized for the year ended
December 31, 2021:
Disclosure of Net Defined Benefit Liability (Asset)
| |
Pension Benefit Plans | | |
Other benefit
plan | | |
Total | |
| |
| $ | | |
| $ | | |
| $ | |
Change in benefit obligation: | |
| | | |
| | | |
| | |
Balances – Beginning of the year | |
| 15,341 | | |
| 94 | | |
| 15,435 | |
Current service cost | |
| 60 | | |
| 5 | | |
| 65 | |
Interest cost | |
| 87 | | |
| 1 | | |
| 88 | |
Actuarial loss (gain) arising from changes in financial assumptions | |
| (1,138 | ) | |
| 8 | | |
| (1,130 | ) |
Past service cost associated with multi-employer plan | |
| 16,137 | | |
| — | | |
| 16,137 | |
Actuarial loss arising from change in current assumptions on funding of future pension increases | |
| 556 | | |
| — | | |
| 556 | |
Benefits paid | |
| (509 | ) | |
| (2 | ) | |
| (511 | ) |
Impact of foreign exchange rate changes | |
| (1,221 | ) | |
| (7 | ) | |
| (1,228 | ) |
Balances – End of the year | |
| 29,313 | | |
| 99 | | |
| 29,412 | |
Obligation is attributable to: | |
| | | |
| | | |
| | |
Active members | |
| 4,242 | | |
| 99 | | |
| 4,341 | |
Vested terminees | |
| 13,799 | | |
| — | | |
| 13,799 | |
Retirees | |
| 11,272 | | |
| — | | |
| 11,272 | |
| |
| 29,313 | | |
| 99 | | |
| 29,412 | |
Change in plan assets | |
| | | |
| | | |
| | |
Balances – Beginning of the year | |
| — | | |
| — | | |
| — | |
Presentation of plan assets as of December 31, 2021 | |
| 11,963 | | |
| — | | |
| 11,963 | |
Impact of foreign exchange rate changes | |
| (36 | ) | |
| — | | |
| (36 | ) |
Balances – End of the year | |
| 11,927 | | |
| — | | |
| 11,927 | |
| |
| | | |
| | | |
| | |
Net liability of the unfunded plans | |
| 12,650 | | |
| 99 | | |
| 12,749 | |
Net liability of the funded plans | |
| 4,736 | | |
| — | | |
| 4,736 | |
Net amount recognized as Employee future benefits | |
| 17,386 | | |
| 99 | | |
| 17,485 | |
| |
| | | |
| | | |
| | |
Amounts recognized: | |
| | | |
| | | |
| | |
In net loss | |
| (147 | ) | |
| (6 | ) | |
| (153 | ) |
In other comprehensive (loss) | |
| 2,407 | | |
| 1 | | |
| 2,408 | |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
cumulative amount of actuarial net losses recognized in other comprehensive loss as of December 31, 2021 is $9,385 ($5,793 as of December
31, 2020 and $5,143 as of December 31, 2019).
The
Company’s proportionate share of the multi-employer pension plan assets as of December 31, 2021 is as follows:
Schedule of Employer Pension Plan Asset
|
|
$ |
|
Quoted
equities (Level 1) |
|
|
826 |
|
Quoted
bonds (Level 1) |
|
|
7,445 |
|
Cash
(Level 1) |
|
|
67 |
|
Real
estate (Level 3) |
|
|
2,207 |
|
Other
(Level 3) |
|
|
1,382 |
|
Total |
|
|
11,927 |
|
The
significant actuarial assumptions applied to determine the Company’s accrued benefit obligations are as follows:
Summary of Significant Actuarial Assumptions Applied to Determine Accrued Benefit Obligations
| |
Pension Benefit Plans | | |
Other benefit plans | |
| |
Years ended December 31, | | |
Years ended December 31, | |
Actuarial assumptions | |
2021 | | |
2020 | | |
2019 | | |
2021 | | |
2020 | | |
2019 | |
| |
| % | | |
| % | | |
| % | | |
| % | | |
| % | | |
| % | |
Discount rate | |
| 1.10 | | |
| 0.60 | | |
| 1.10 | | |
| 1.10 | | |
| 0.60 | | |
| 1.90 | |
Pension benefits increase | |
| 0.50 | | |
| 0.50 | | |
| 1.50 | | |
| 0.50 | | |
| 0.50 | | |
| 1.50 | |
Rate of compensation increase | |
| 2.50 | | |
| 2.00 | | |
| 2.00 | | |
| 2.50 | | |
| 2.00 | | |
| 2.00 | |
During
2020, management expanded its assumptions of possible future compensation scenarios from its current three-year forecast to a thirty-year
forecast and from using an expected average inflation rate to an expected inflation rate. Additionally, the Company included the potential
claims of retirees within the thirty-year time horizon. The Company expects to invest in its R&D opportunities, which would not change
its economic situation in the short term but, if successful, does allow for scenarios that such pension increases would be owing. Such
potential future pension compensation obligations have been included in the revised forecast assumptions, at a rate of 0.50%, in addition
to an expected inflation rate of 1.75%. These assumptions remain unchanged in 2021.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Assumptions
regarding future mortality are set based on actuarial advice in accordance with published statistics and experience in Germany. These
assumptions translate into an average remaining life expectancy in years for a pensioner retiring at age 65:
Summary of Assumptions Translate into an Average Remaining Life Expectancy in Years
| |
2021 | | |
2020 | | |
2019 | |
Retiring at the end of the reporting period: | |
| | | |
| | | |
| | |
Male | |
| 21 | | |
| 20 | | |
| 20 | |
Female | |
| 24 | | |
| 24 | | |
| 24 | |
Retiring 20 years after the end of the reporting period: | |
| | | |
| | | |
| | |
Male | |
| 28 | | |
| 28 | | |
| 28 | |
Female | |
| 31 | | |
| 31 | | |
| 31 | |
The
most recent actuarial reports give effect to the pension and post-employment benefit obligations as of December 31, 2021. The next actuarial
reports are planned for December 31, 2022.
In
accordance with the assumptions used as of December 31, 2021, undiscounted defined pension benefits expected to be paid are as follows:
Summary of Undiscounted Defined Pension Benefits Expected to be Paid
|
|
|
Total
$ |
|
2022 |
|
|
801 |
|
2023 |
|
|
823 |
|
2024 |
|
|
853 |
|
2025 |
|
|
868 |
|
2026 |
|
|
894 |
|
Thereafter |
|
|
32,685 |
|
|
|
|
36,924 |
|
The
weighted average duration of the defined benefit obligation is 16.0 years.
If
variations in the following assumptions had occurred during 2021, the impact on the Company’s pension benefit obligation of $29,313
as of December 31, 2021 would have been as follows:
Summary of Impact on Pension Benefit Obligation
Assumption | |
Increase | | |
Decrease | |
| |
| | |
| |
| |
| (1,252 | ) | |
| 1,338 | |
Change in discount rate of 0.25% | |
| (1,252 | ) | |
| 1,338 | |
Change in salary rate of 0.25% | |
| 18 | | |
| (18 | ) |
Change in pension rate assumption by % | |
| 905 | | |
| (867 | ) |
Change mortality by one year | |
| 968 | | |
| (974 | ) |
Total
expenses for the defined benefit plan that the Company accounts for as a defined contribution plan amounted to approximately
$45 for the year ended December 31, 2021 (2020 - $38 and 2019 - $54).
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
19. |
Share capital, warrants and other capital |
(a) Share capital
The
Company has an unlimited number of authorized common shares (being voting and participating shares) with no par value, as well as an
unlimited number of preferred, first and second ranking shares, issuable in series, with rights and privileges specific to each class,
with no par value.
2021
During
the year ended December 31, 2021, certain warrant holders exercised outstanding warrants to purchase 35,111,187 of our common shares
for gross proceeds of approximately $20.1 million (such exercises, the “2021 Warrant Exercises”).
On
February 19, 2021, the Company completed an underwritten public offering of 20,509,746 common shares at $1.45 per common share, resulting
in aggregate gross proceeds of $29,739, less underwriting discounts, commissions and offering expenses of $2,837 (the “February
2021 Financing”). The Company also granted to the underwriter and placement agent (the “Underwriter”), a 30-day over-allotment
option to purchase up to 3,076,461 additional common shares at a price of $1.45 per common share (the “Underwriter Option”).
Additionally, the Company issued warrants underlying 1,435,682 common shares to the Underwriter, with each warrant bearing an exercise
price of $1.8125 (the “February 2021 Placement Agent Warrants”). The February 2021 Placement Agent Warrants expire on February
17, 2026.
On
February 22, 2021, the Underwriter exercised the Underwriter Option and received 3,076,461 common shares in exchange for gross proceeds
to the Company of $4,461. Upon exercise of the Underwriter Option, the Underwriter also received an additional 215,352 February 2021
Placement Agent Warrants.
Aggregate
gross proceeds received in connection with the February 2021 Financing totaled $34,200, less cash transaction costs of $3,221 and non-cash
transaction costs, which represent the issue-date fair value of the February 2021 Placement Agent Warrants, of $1,897.
2020
On
February 21, 2020, the Company closed a registered direct offering for 3,478,261 common shares, at a purchase price of $1.29 per share,
priced at-the-market. Additionally, 2,608,696 investor warrants were issued at an exercise price of $1.20 per common share and 243,478
broker warrants were issued at an exercise price of $1.62 per common share. The net cash proceeds to the Company from the offering totaled
$3,900. The gross proceeds of $4,500 was allocated as $2,325 to warrant liability based on the ascribed fair value and the remaining
gross proceeds of $2,174 were allocated to share capital. The transaction costs of $600 were allocated between share capital and warrants
based on their relative fair values. The fair value of the share capital was recorded within equity net of the allocated transaction
costs. The transaction costs of $311 allocated to the warrant liability were recorded as expense in the consolidated statement of comprehensive
loss.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
On
July 7, 2020, the Company closed a public offering of 26,666,666 units at a price of $0.45 per unit, for net cash proceeds to the Company
of $10,596. Each unit contained one common share (or common share equivalent in lieu thereof) and one investor warrant to purchase one
common share. In total, 26,666,666 common shares, 26,666,666 investor warrants at an exercise price of $0.45 per share expiring July
7, 2025 (the “July 2020 Investor Warrants”) and 1,866,667 placement agent warrants with an exercise price of $0.5625 per
share, expiring July 1, 2025 (the “July 2020 Placement Agent Warrants”) were issued. As these warrants were registered and
can be settled for a fixed number of the Company’s underlying common shares, the warrants meet the requirements of the fixed-for-fixed
rule and have been classified as equity.
Because
the warrants were classified as equity, the gross proceeds of $12,000 were allocated as $6,308 to share capital and $5,691 to warrants
based on their relative fair values. The transaction costs of $1,420 were reduced from share capital and warrants in the amounts of $754
and $666, respectively, and charged to share issuance costs and classified as equity. The values ascribed to the share capital and warrants
were recorded within equity, net of the allocated transaction costs.
On
August 5, 2020, the Company closed a securities purchase agreement of 12,427,876 common shares at a purchase price of $0.56325 per common
share. The offering resulted in gross proceeds of $7,000. Concurrently, the Company issued to the purchasers unregistered warrants to
purchase up to an aggregate of 9,320,907 common shares. The warrants are exercisable for a period of five and one-half years, exercisable
immediately following the issuance date and have an exercise price of $0.47 per common share. In addition, the Company issued unregistered
warrants to the placement agent to purchase up to an aggregate of 869,952 common shares, with an exercise price of $0.7040625 per share
and an expiration date of August 3, 2025. The gross proceeds of $7,000 was allocated as $3,944 to warrant liability based on the ascribed
fair value and the remaining gross proceeds of $3,056 were allocated to share capital. The transaction costs of $748 were allocated between
share capital and warrants based on their relative fair values. The fair value of the share capital was recorded within equity net of
the allocated transaction costs of $327. The transaction costs of $421 allocated to the warrant liability were recorded as expense in
the consolidated statement of comprehensive loss.
2019
On
September 20, 2019, the Company entered into a securities purchase agreement with US institutional investors to purchase $4,988 (before
total transaction costs of $795) of its common shares in a registered direct offering and warrants with a cashless exercise feature to
purchase common shares in a concurrent private placement (together, the “Offering”). The combined purchase price for one
common share and one warrant was $1.50. Under the terms of the securities purchase agreement, the Company sold 3,325,000 common shares.
The gross proceeds of $4,988 was allocated as $3,457 to warrants based on the ascribed fair value and the remaining gross proceeds of
$1,531 were allocated to share capital. The transaction costs of $795 were allocated between share capital and warrants based on their
relative fair values. The fair value of the share capital was recorded within equity net of the allocated transaction costs. The transaction
costs of $550 allocated to the warrant liability were recorded as expense in the consolidated statements of comprehensive loss.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Shareholder
rights plan
Effective
May 8, 2019, the shareholders re-approved the Company’s shareholder rights plan (the “Rights Plan”) that provides the
board of directors and the Company’s shareholders with additional time to assess any unsolicited take-over bid for the Company
and, where appropriate, to pursue other alternatives for maximizing shareholder value. Under the Rights Plan, one right has been issued
for each currently issued common share, and one right will be issued with each additional common share that may be issued from time to
time.
(b) Warrants
Schedule
of Warrants Activity Reclassified into Equity
| |
| | |
Weighted average exercise price | | |
| |
| |
Number | | |
($) | | |
$ | |
Balance – January 1, 2020 | |
| — | | |
| — | | |
| — | |
Warrant liability reclassified to equity | |
| 16,368,033 | | |
| 0.8556 | | |
| 7,377 | |
Warrants issued as equity | |
| 28,533,333 | | |
| 0.4574 | | |
| 5,025 | |
Balance – December 31, 2020 | |
| 44,901,366 | | |
| 0.6025 | | |
| 12,402 | |
February 2021 Placement Agent Warrants | |
| 1,651,034 | | |
| 1.8125 | | |
| 1,897 | |
Warrants exercised | |
| (35,111,187 | ) | |
| 0.5725 | | |
| (9,746 | ) |
Allocation of transaction costs to share capital | |
| — | | |
| — | | |
| 532
| |
Balance – December 31, 2021 | |
| 11,441,213 | | |
| 0.8668 | | |
| 5,085 | |
i)
Warrants granted in 2021
The
table presented below shows the inputs and assumptions applied to the Black-Scholes option pricing model in order to determine the fair
value of the February 2021 Placement Agent Warrants:
Schedule of Fair Value of Warrants Assumptions
| |
Number of equivalent shares | | |
Market value per share price | | |
Weighted average exercise price | | |
Risk-free annual interest rate | | |
Expected volatility | | |
Expected life (years) | | |
Expected dividend yield | |
| |
# | | |
$ | | |
$ | | |
(i) | | |
(ii) | | |
(iii) | | |
(iv) | |
February 2021 Placement Agent Warrants issued on February 19, 2021 | |
| 1,435,682 | | |
| 1.48 | | |
| 1.8125 | | |
| 0.58734 | % | |
| 119.18 | % | |
| 4.99 | | |
| 0.00 | % |
February 2021 Placement Agent Warrants issued on February 22, 2021 | |
| 215,352 | | |
| 1.48 | | |
| 1.8125 | | |
| 0.58544 | % | |
| 119.57 | % | |
| 4.98 | | |
| 0.00 | % |
|
(i) |
Based
on United States Treasury Government Bond interest rates with a term that is consistent with the expected life of the warrants. |
|
(ii) |
Based
on the historical volatility of the Company’s stock price over the most recent period consistent with the expected life of
the warrants. |
|
(iii) |
Based
upon time to expiry from the issuance date. |
|
(iv) |
The
Company has not paid dividends and it does not intend to pay dividends in the foreseeable future. |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
ii)
Warrants exercised in 2021
During
2021, certain warrant holders exercised their warrants as follows:
Summary
of Warrants Exercise Transactions
| |
Warrants exercised (number of underlying common shares) | | |
Exercise Price | | |
Aggregate proceeds to the Company | |
September 2019 Investor warrants | |
| 2,000,000 | | |
$ | 1.65 | | |
$ | 3,300 | |
February 2020 Investor warrants | |
| 1,739,130 | | |
| 1.20 | | |
| 2,087 | |
July 2020 Investor warrants | |
| 21,045,555 | | |
| 0.45 | | |
| 9,471 | |
July 2020 Placement Agent warrants | |
| 1,866,667 | | |
| 0.5625 | | |
| 1,050 | |
August 2020 Investor warrants | |
| 7,589,883 | | |
| 0.47 | | |
| 3,567 | |
August 2020 Placement Agent warrants | |
| 869,952 | | |
| 0.7040625 | | |
| 612 | |
| |
| 35,111,187 | | |
| | | |
$ | 20,087 | |
iii)
Warrant liability reclassified to equity in 2020
The
Company had issued 3,325,000 unregistered investor warrants in the September 2019 closed direct offering (the “September 2019 Warrants”)
as well as 2,608,696 unregistered investor warrants (the “February 2020 Investor Warrants”) and 243,478 unregistered placement
agent warrants (the “February 2020 Placement Agent Warrants”) in the February 2020 closed direct offering transaction. The
terms of the warrant agreement stated that if the warrants remained unregistered, the warrant holder could elect to exercise the warrants
by way of a cashless exercise. This violated the fixed-for-fixed criterion due to the cashless exercise option, and accordingly these
warrants had been accounted for as a liability.
Effective
June 16, 2020, the Company registered the common shares underlying these warrants by way of a registration statement which eliminated
the cashless exercise option on the warrants, on a one-for-one basis. Accordingly, as of June 16, 2020, the warrant liability was remeasured
at fair value using the Black-Scholes option pricing model, with the amount of the remeasurement loss recognized in the consolidated
statement of comprehensive loss. The carrying value of the warrants was then reclassified from warrant liability to other capital within
equity.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
Company also issued 9,320,907 unregistered investor warrants (the “August 2020 Investor Warrants”) and 869,952 unregistered
placement agent warrants (the “August 2020 Placement Agent Warrants”) in the August 2020 registered direct offering transaction.
The terms of the warrant agreement stated that if the warrants remained unregistered, the warrant holder could elect to exercise the
warrants by way of a cashless exercise. This violated the fixed-for-fixed criterion due to the cashless exercise option, and accordingly
these warrants were accounted for as a liability on issuance and measured at fair value using the Black-Scholes option pricing model.
Effective September 14, 2020, the Company registered the common shares underlying these warrants by way of a registration statement which
eliminated the cashless exercise option on the warrants, on a one-for-one basis. Accordingly, as of September 14, 2020, the warrant liability
was remeasured at fair value using the Black-Scholes option pricing model, with the amount of the remeasurement loss recognized in the
consolidated statement of comprehensive loss. The carrying value of the warrants was then reclassified from warrant liability to other
capital within equity.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
iv)
Warrants issued as equity in 2020
On
July 7, 2020, the Company closed a public offering of 26,666,666 units at a price of $0.45 per unit, for net cash proceeds to the Company
of $10,596. Each unit contained one common share (or common share equivalent in lieu thereof) and one investor warrant to purchase one
common share. In total, 26,666,666 common shares, 26,666,666 July 2020 Investor Warrants and 1,866,667 July 2020 Placement Agent Warrants
were issued. As these warrants were registered and can be settled for a fixed number of the Company’s underlying common shares,
the warrants meet the requirements of the fixed-for-fixed rule were classified as equity.
(c)
Other capital
Long-term
incentive plan
At
the 2018 annual and special meeting of shareholders, the Company’s shareholders approved the adoption of the 2018 long-term incentive
plan (the “LTIP”), which allows the Board of Directors to issue up to 11.4% of the total issued and outstanding common shares
at any given time to eligible individuals at an exercise price to be determined by the Board of Directors at the time of the grant, subject
to a ceiling, as stock options, stock appreciation rights, stock awards, deferred stock units (“DSUs”), performance shares,
performance units, and other stock-based awards. This LTIP replaces the stock option plan (the “Stock Option Plan”) for its
directors, senior executives, employees and other collaborators who provide services to the Company. Options granted under the LTIP expire
after seven years following the date of grant, vest over three years, beginning one year after date of grant. The Company’s Board
of Directors amended the Stock Option Plan on March 20, 2014 and the Company’s Shareholders approved, ratified and confirmed the
Stock Option Plan on May 10, 2016. Options granted under the Stock Option Plan prior to the 2014 amendment expire after a maximum period
of 10 years following the date of grant. Options granted after the 2014 amendment expire after a maximum period of seven years following
the date of grant.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
Company settles stock options exercised through the issuance of new common shares as opposed to purchasing common shares on the market
to settle stock option exercises.
As
of December 31, 2021, the total compensation cost related to unvested US dollar stock options not yet recognized amounted to $96 (2020
- $43 and 2019 - $101). This amount is expected to be recognized over a weighted average period of 1.54 years (2020 - 1.43 years and
2019 1.21 years).
Disclosure of Change in Stock Options Issued
| |
Year ended December 31, 2021 | |
| |
Stock options | | |
Weighted average exercise price | | |
DSUs | |
| |
(Number) | | |
($) | | |
(Number) | |
Balance – January 1, 2021 | |
| 506,400 | | |
| 1.44 | | |
| 173,000 | |
Granted | |
| 580,000 | | |
| 0.42 | | |
| 280,000 | |
Expired | |
| (32 | ) | |
| 590.25 | | |
| — | |
Exercised | |
| — | | |
| — | | |
| (30,000 | ) |
Balance – December 31, 2021 | |
| 1,086,368 | | |
| 0.88 | | |
| 423,000 | |
| |
Year ended December 31, 2019 | |
| |
US$ Stock options | | |
Weighted average exercise price | | |
DSUs | | |
CAN$ Stock options | | |
Weighted average exercise price | |
| |
(Number) | | |
(US$) | | |
(Number) | | |
(Number) | | |
(CAN$) | |
Balance – Beginning of year | |
| 727,816 | | |
| 4.07 | | |
| 161,000 | | |
| 869 | | |
| 743.56 | |
Granted | |
| 185,000 | | |
| 1.07 | | |
| 150,000 | | |
| — | | |
| — | |
Exercised | |
| (64,850 | ) | |
| 2.75 | | |
| (99,000 | ) | |
| — | | |
| — | |
Canceled/Forfeited | |
| (6,000 | ) | |
| 13.39 | | |
| — | | |
| — | | |
| — | |
Expired | |
| (100,850 | ) | |
| 2.24 | | |
| — | | |
| (428 | ) | |
| 570.00 | |
Balance – End of year | |
| 741,116 | | |
| 3.61 | | |
| 212,000 | | |
| 441 | | |
| 912.00 | |
| |
Year ended December 31, 2020 | |
| |
US$ Stock options | | |
Weighted average exercise price | | |
DSUs | | |
CAN$ Stock options | | |
Weighted
average exercise price | |
| |
(Number) | | |
(US$) | | |
(Number) | | |
(Number) | | |
(CAN$) | |
Balance – Beginning of year | |
| 741,116 | | |
| 3.61 | | |
| 212,000 | | |
| 441 | | |
| 912.00 | |
Granted | |
| 180,000 | | |
| 0.37 | | |
| 120,000 | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| (159,000 | ) | |
| — | | |
| — | |
Canceled/Forfeited | |
| (330,350 | ) | |
| 2.56 | | |
| — | | |
| — | | |
| — | |
Expired | |
| (84,366 | ) | |
| 2.14 | | |
| — | | |
| (441 | ) | |
| 912.00 | |
Balance – End of year | |
| 506,400 | | |
| 1.44 | | |
| 173,000 | | |
| — | | |
| — | |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Fair
value input assumptions for US dollar stock option grants
The
table below shows the assumptions, or weighted average parameters, applied to the Black-Scholes option pricing model in order to determine
share-based compensation costs over the life of the awards.
Summary of Assumptions to Determine Share-Based Compensation Costs Over the Life of Awards
| |
| | |
2021 | | |
2020 | | |
2019 | |
| |
| | |
Years ended December 31, | |
| |
| | |
2021 | | |
2020 | | |
2019 | |
Expected dividend yield | |
| (a) | | |
| 0.00 | % | |
| 0.00 | % | |
| 0.00 | % |
Expected volatility | |
| (b) | | |
| 115.80 | % | |
| 112.50 | % | |
| 110.02 | % |
Risk-free annual interest rate | |
| (c) | | |
| 1.23 | % | |
| 0.27 | % | |
| 1.86 | % |
Expected life (years) | |
| (d) | | |
| 5.71 | | |
| 4.02 | | |
| 5.94 | |
Weighted average share price | |
| | | |
$ | 0.42 | | |
$ | 0.37 | | |
$ | 2.00 | |
Weighted average exercise price | |
| | | |
$ | 0.42 | | |
$ | 0.37 | | |
$ | 2.00 | |
Weighted average grant date fair value | |
| | | |
$ | 0.35 | | |
$ | 0.27 | | |
$ | 2.00 | |
_________________________
|
(a) |
The
Company has not paid dividends and it does not intend to pay dividends in the foreseeable future. |
|
|
|
|
(b) |
Based
on the historical volatility of the Company’s stock price over the most recent period consistent with the expected life of
the stock options, as well as on future expectations. |
|
|
|
|
(c) |
Based
on United States Treasury Government Bond interest rates with a term that is consistent with the expected life of the stock options. |
|
|
|
|
(d) |
Based
upon historical data related to the exercise of stock options, on post-vesting employment terminations and on future expectations
related to exercise behavior. |
Schedule of Stock Options Exercise Price Range
| |
Options outstanding | | |
Options exercisable | |
Range of US dollar stock option exercise prices | |
Number (#) | | |
Weighted average remaining contractual life (years) | | |
Weighted average exercise price ($) | | |
Number (#) | | |
Weighted average remaining contractual life (years) | | |
Weighted average exercise price ($) | |
0.37 to 0.50 | |
| 760,000 | | |
| 6.72 | | |
| 0.41 | | |
| 60,006 | | |
| 5.95 | | |
| 0.37 | |
0.51 to 1.78 | |
| 160,000 | | |
| 4.91 | | |
| 0.91 | | |
| 106,672 | | |
| 4.91 | | |
| 0.90 | |
1.79 to 3.14 | |
| 85,000 | | |
| 3.21 | | |
| 2.08 | | |
| 76,667 | | |
| 3.06 | | |
| 2.07 | |
3.15 to 217.00 | |
| 81,368 | | |
| 1.70 | | |
| 3.95 | | |
| 81,368 | | |
| 1.70 | | |
| 3.95 | |
| |
| 1,086,368 | | |
| 5.81 | | |
| 0.88 | | |
| 324,713 | | |
| 3.86 | | |
| 1.84 | |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
nature of the Company’s operating expenses includes the following:
Schedule of Operating Expenses
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
| |
$ | | |
$ | | |
$ | |
Key management personnel compensation(1) | |
| | | |
| | | |
| | |
Salaries and short-term employee benefits(1) | |
| 1,646 | | |
| 1,540 | | |
| 1,705 | |
Consultant’s fees(1) | |
| 163 | | |
| 167 | | |
| 194 | |
Termination benefits(1) | |
| — | | |
| — | | |
| 503 | |
Post-employment benefits, including defined contribution
plan benefits of $33
in 2021, $33
in 2020 and $195
in 2019(1) | |
| 70 | | |
| 86 | | |
| 257 | |
Share-based compensation costs(1) | |
| 295 | | |
| 160 | | |
| 784 | |
Key management personnel
compensation(1) | |
| 2,174 | | |
| 1,953 | | |
| 3,443 | |
Other employees compensation: | |
| | | |
| | | |
| | |
Salaries and short-term employee benefits | |
| 1,160 | | |
| 1,004 | | |
| 1,257 | |
Post-employment benefits, including defined contribution plan benefits of $15 in 2021, $9 in 2020 and $25 in 2019 | |
| 139 | | |
| 159 | | |
| 78 | |
Share-based compensation costs | |
| 16 | | |
| (99 | ) | |
| 9 | |
Other employees compensation | |
| 1,315 | | |
| 1,064 | | |
| 1,344 | |
Cost of inventory used and services provided | |
| 90 | | |
| 2,186 | | |
| 309 | |
Professional fees | |
| 2,749 | | |
| 1,969 | | |
| 2,599 | |
Insurance | |
| 1,077 | | |
| 861 | | |
| 890 | |
Third-party research and development | |
| 5,047 | | |
| 414 | | |
| 322 | |
Consulting fees | |
| 553 | | |
| 587 | | |
| 144 | |
Restructuring costs | |
| — | | |
| — | | |
| 507 | |
Travel | |
| 130 | | |
| 66 | | |
| 154 | |
Marketing services | |
| 222 | | |
| 39 | | |
| 18 | |
Laboratory supplies | |
| 114 | | |
| 36 | | |
| 23 | |
Other goods and services | |
| 162 | | |
| 72 | | |
| 137 | |
Leasing costs, net of sublease receipts of $nil in 2021, $nil in 2020 and $214 in 2019 | |
| 112 | | |
| 218 | | |
| 247 | |
Modification of building lease | |
| — | | |
| (219 | ) | |
| — | |
(Reversal) impairment of other asset and inventory | |
| — | | |
| (8 | ) | |
| 270 | |
Depreciation and amortization of property, equipment and intangibles | |
| 25 | | |
| 29 | | |
| 37 | |
Depreciation - right to use assets | |
| 120 | | |
| 203 | | |
| 278 | |
Impairment of right of use asset | |
| — | | |
| — | | |
| 22 | |
Operating foreign exchange losses (gains) | |
| 41 | | |
| (112 | ) | |
| 30 | |
Operating expenses excluding
management and Employee compensation | |
| 10,442 | | |
| 6,341 | | |
| 5,987 | |
Total operating expenses | |
| 13,931 | | |
| 9,358 | | |
| 10,774 | |
______________________
(1) | Key management
includes the Company’s executive management team and directors. |
Most
of the employment agreements entered into between the Company and its executive officers include termination provisions, whereby the
executive officers would be entitled to receive benefits that would be payable if the Company were to terminate the executive officers’
employment without cause or if their employment is terminated following a change of control. Separation benefits generally are calculated
based on an agreed-upon multiple of applicable base salary and incentive compensation and, in certain cases, other benefit amounts.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
21. |
Supplemental disclosure of cash flow information |
Disclosure of Changes in Operating Assets and Liabilities
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
| |
| $ | | |
| $ | | |
| $ | |
Changes in operating assets and liabilities: | |
| | | |
| | | |
| | |
Trade and other receivables | |
| 120 | | |
| (1,023 | ) | |
| (371 | ) |
Inventory | |
| (56 | ) | |
| 1,182 | | |
| (971 | ) |
Prepaid expenses and other current assets | |
| (750 | ) | |
| (702 | ) | |
| (170 | ) |
Payables and accrued liabilities | |
| 634 | | |
| 51 | | |
| (615 | ) |
Income taxes payable | |
| (109 | ) | |
| 395 | | |
| (188 | ) |
Deferred revenues | |
| 3,010 | | |
| 3,031 | | |
| 743 | |
Provision for restructuring and other costs | |
| — | | |
| — | | |
| (389 | ) |
Employee future benefits (note 18) | |
| (349 | ) | |
| (532 | ) | |
| (483 | ) |
Increase (decrease) in
operating assets and liabilities | |
| 2,500 | | |
| 2,402 | | |
| (2,444 | ) |
Significant
components of the current and deferred income tax recovery (expense) for the years ended December 31, 2021, 2020 and 2019 are as follows:
Summary of Significant Components of Current and Deferred Income Tax Recovery (Expense)
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
| |
| $ | | |
| $ | | |
| $ | |
Current income tax recovery (expense) | |
| 109 | | |
| (395 | ) | |
| 188 | |
Deferred tax: | |
| | | |
| | | |
| | |
Origination and reversal of temporary differences | |
| 1,291 | | |
| 1,509 | | |
| 2,755 | |
Change in unrecognized tax assets | |
| (1,291 | ) | |
| (1,509 | ) | |
| (2,755 | ) |
Total income tax recovery (expense) | |
| 109 | | |
| (395 | ) | |
| 188 | |
From
time to time, the Company is subject to tax audits. While the Company believes that its filing positions are appropriate and supportable,
periodically, certain matters are challenged by tax authorities. Although the Company believes its tax provisions are adequate, the final
determination of tax audits and any related disputes could be materially different from historical income tax provisions and accruals.
In 2020, AEZS Germany underwent a tax audit regarding the taxation years 2013 to 2016. As of December 31, 2021, the tax authorities concluded
the audit for those years. The subsequent years remain unaudited, and the Company has accrued $115 as an uncertain tax provision for
those years. In addition, as of December 31, 2021, AEZS Germany paid instalments in the amount of $1,605 for the 2021 tax year and $1,448
in estimated taxes payable for the 2020 tax year.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
reconciliation of the combined Canadian federal and provincial corporate income tax rate to the income tax expense is provided below:
Summary of Reconciliation of Combined Canadian Federal and Provincial Income Tax Rate to Income Tax Expense
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
Combined Canadian federal and provincial statutory income tax rate | |
| 26.5 | % | |
| 26.5 | % | |
| 26.5 | % |
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
| |
$ | | |
$ | | |
$ | |
Income tax (expense) recovery based on combined statutory income tax rate | |
| 2,246 | | |
| 1,252 | | |
| 1,615 | |
Change in unrecognized tax assets | |
| (1,291 | ) | |
| (1,872 | ) | |
| (2,820 | ) |
| |
| | | |
| | | |
| | |
Share issuance costs | |
| 367 | | |
| 363 | | |
| 65 | |
Permanent difference attributable to the use of local currency for tax reporting | |
| — | | |
| — | | |
| 35 | |
Change in enacted rates used | |
| — | | |
| — | | |
| (27 | ) |
Impact of expiring tax credits | |
| (1,724 | ) | |
| (481 | ) | |
| — | |
Provision to filed return adjustments | |
| 151 | | |
| — | | |
| — | |
Permanent difference attributable to net change in fair value of warrant liability | |
| — | | |
| 304 | | |
| 1,197 | |
Share-based compensation costs | |
| (82 | ) | |
| (16 | ) | |
| (210 | ) |
Difference in statutory income tax rate of foreign subsidiaries | |
| 226 | | |
| 99 | | |
| 321 | |
Uncertain tax position | |
| — | | |
| (123 | ) | |
| — | |
Other | |
| 216 | | |
| 79 | | |
| 12 | |
Total
income tax (expense) recovery | |
| 109 | | |
| (395 | ) | |
| 188 | |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
(Loss)
income before income taxes
(Loss)
income before income taxes is attributable to the Company’s tax jurisdictions as follows:
Summary of (Loss) Income Before Income Taxes
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
| |
$ | | |
$ | | |
$ | |
Germany | |
| (4,383 | ) | |
| (2,042 | ) | |
| (6,010 | ) |
Canada | |
| (3,860 | ) | |
| (2,463 | ) | |
| 812 | |
United States | |
| (234 | ) | |
| (218 | ) | |
| (1,032 | ) |
Loss before income taxes | |
| (8,477 | ) | |
| (4,723 | ) | |
| (6,230 | ) |
Significant
components of deferred tax assets and liabilities are as follows:
Summary of Significant Components of Deferred Tax Assets and Liabilities
| |
2021 | | |
2020 | |
| |
December 31, | |
| |
2021 | | |
2020 | |
| |
$ | | |
$ | |
Deferred tax assets | |
| | | |
| | |
| |
| | | |
| | |
Operating losses carried forward | |
| 205 | | |
| 46 | |
Intangible assets | |
| 776 | | |
| 1,318 | |
Deferred tax assets | |
| 981 | | |
| 1,364 | |
Deferred tax liabilities | |
| | | |
| | |
| |
| | | |
| | |
Accounts receivable | |
| 375 | | |
| — | |
Payables and accrued liabilities | |
| 7 | | |
| 126 | |
Property, plant and equipment | |
| 47 | | |
| 49 | |
Deferred revenues | |
| 492 | | |
| 1,073 | |
Other | |
| 60 | | |
| 116 | |
Deferred tax liabilities | |
| 981 | | |
| 1,364 | |
Deferred
tax liabilities, net | |
| 981 | | |
| 1,364 | |
Deferred tax assets (liabilities), net | |
| — | | |
| — | |
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Significant
components of deferred tax assets and losses are as follows:
Summary of Significant Components of Unrecognized Deferred Tax Assets
| |
2021 | | |
2020 | |
| |
December 31, | |
| |
2021 | | |
2020 | |
| |
$ | | |
$ | |
Unrecognized deferred tax assets | |
| | | |
| | |
| |
| | | |
| | |
Deferred revenues and other provisions | |
| 1,680 | | |
| 1,494 | |
Operating losses carried forward | |
| 87,734 | | |
| 89,144 | |
Capital losses carried forward | |
| 105 | | |
| — | |
SR&ED Pool | |
| 9,138 | | |
| 9,138 | |
Unused tax credits | |
| 2,945 | | |
| 4,668 | |
Employee future benefits | |
| 3,396 | | |
| 2,570 | |
Property, plant and equipment | |
| 523 | | |
| 495 | |
Intangible assets | |
| — | | |
| 541 | |
Share issuance expenses | |
| 1,110 | | |
| 623 | |
Other | |
| 84 | | |
| — | |
Unrecognized deferred
tax assets, gross | |
| 106,715 | | |
| 108,673 | |
Unrecognized deferred tax assets | |
| 106,715 | | |
| 108,673 | |
Deferred
income tax assets are recognized to the extent that the realization of the related tax benefit through reversal of temporary differences
and future taxable profits is probable. Based on the current forecasted future taxable profits and reversal of temporary differences,
the company does not believe it will have sufficient future earnings to offset the deferred tax assets and has an unrecognized deferred
tax asset balance of $106,715.
As
at December 31, 2021, the Corporation has total accumulated non-capital losses of $77,867 federally and $76,545 provincially, which may
be carried forward for twenty years and used to reduce taxable income in future years. The Corporation has not recognized deferred tax
assets on any of the non-capital losses, due to the uncertainty that there will be sufficient taxable income or that the taxable temporary
differences will be reversing in the same reporting period and jurisdiction. The losses will be expiring as follows:
Summary of Disclosure of Federal Tax Losses
|
|
Federal |
|
|
Provincial |
|
|
|
Canada |
|
|
|
Federal |
|
|
Provincial |
|
|
|
$ |
|
|
$ |
|
2028 |
|
|
8,054 |
|
|
|
6,668 |
|
2029 |
|
|
4,791 |
|
|
|
4,773 |
|
2030 |
|
|
4,104 |
|
|
|
4,089 |
|
2031 |
|
|
1,753 |
|
|
|
1,737 |
|
2032 |
|
|
4,250 |
|
|
|
4,250 |
|
2033 |
|
|
3,721 |
|
|
|
3,721 |
|
2034 |
|
|
4,153 |
|
|
|
4,153 |
|
2035 |
|
|
10,418 |
|
|
|
10,452 |
|
2036 |
|
|
10,592 |
|
|
|
10,592 |
|
2037 |
|
|
7,343 |
|
|
|
7,343 |
|
2038 |
|
|
6,557 |
|
|
|
6,557 |
|
2039 |
|
|
3,501 |
|
|
|
3,580 |
|
2040 |
|
|
3,808 |
|
|
|
3,808 |
|
2041 |
|
|
4,822 |
|
|
|
4,822 |
|
Tax
attributes to be deferred for which no deferred tax asset was recognized |
|
|
77,867 |
|
|
|
76,545 |
|
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
Company has non-refundable R&D investment tax credits of approximately $4,006 which can be carried forward to reduce Canadian federal
income taxes payable and which expire at dates ranging from 2022 to 2035. Furthermore, the Company has unrecognized tax assets in respect
of operating losses to be carried forward in Germany and in the US The federal tax losses amount to approximately $210,709 in Germany
(€ 185,271) for which there is no expiry date, and to $4,793 in the US. The losses in the US will be expiring as follows:
The
operating loss carryforwards and the tax credits claimed are subject to review, and potential adjustment, by tax authorities. Other deductible
temporary differences for which tax assets have not been booked are not subject to a time limit, except for share issuance expenses which
are amortizable over five years.
The
Company’s objective in managing capital, consisting of shareholders’ equity, with cash and cash equivalents and restricted
cash equivalents being its primary components, is to ensure sufficient liquidity to fund R&D costs, selling expenses, general and
administrative expenses and working capital requirements. Over the past several years, the Company has raised capital via public and
private equity offerings and issuances as its primary source of liquidity, as discussed in note 19 - share capital, warrants and other
capital. The capital management objective of the Company remains the same as that in previous periods. The policy on dividends is to
retain cash to keep funds available to finance the activities required to advance the Company’s product development portfolio and
to pursue appropriate commercial opportunities as they may arise.
The
Company is not subject to any capital requirements imposed by any regulators or by any other external source.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
24. |
Financial instruments and financial risk management |
Financial
assets and liabilities as of December 31, 2021 and December 31, 2020 are presented below.
Disclosure of Fair Value Measurement
of Assets
December 31, 2021 | |
Financial assets at amortized cost | | |
Financial liabilities at amortized cost | |
| |
$ | | |
$ | |
Cash and cash equivalents (note 6) | |
| 65,300 | | |
| — | |
Trade and other receivables (note 7) | |
| 1,314 | | |
| — | |
Restricted cash equivalents (note 10) | |
| 335 | | |
| — | |
Payables and accrued liabilities (note 15) | |
| — | | |
| 1,530 | |
Lease liability (note 17) | |
| — | | |
| 161 | |
| |
| 66,949 | | |
| 1,691 | |
December 31, 2020 | |
Financial assets at amortized cost | | |
Financial liabilities at amortized cost | |
| |
$ | | |
$ | |
Cash and cash equivalents (note 6) | |
| 24,271 | | |
| — | |
Trade and other receivables (note 7) | |
| 1,681 | | |
| — | |
Restricted cash equivalents (note 10) | |
| 338 | | |
| — | |
Payables and accrued liabilities (note 15) | |
| — | | |
| 2,176 | |
Lease liability (note 17) | |
| — | | |
| 184 | |
| |
| 26,290 | | |
| 2,360 | |
Fair
value
IFRS
13, Fair Value Measurement (“IFRS 13”) establishes a hierarchy that prioritizes the inputs used to measure fair value.
The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement)
and the lowest priority to unobservable inputs (Level 3 measurement).
The
input levels discussed in IFRS 13 are:
Level
1 – Unadjusted quoted prices in active markets for identical assets or liabilities.
Level
2 – Inputs other than quoted prices included within Level 1 that are observable for an asset or liability, either directly (i.e.
prices) or indirectly (i.e. derived from prices).
Level
3 – Inputs for an asset or liability that are not based on observable market data (unobservable inputs).
The
carrying values of the Company’s cash and cash equivalents, trade and other receivables, restricted cash equivalents, payables
and accrued liabilities and provision for restructuring and other costs approximate their fair values due to their short-term maturities
or to the prevailing interest rates of the related instruments, which are comparable to those of the market.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Financial
risk factors
The
following provides disclosures relating to the nature and extent of the Company’s exposure to risks arising from financial instruments,
including credit risk, liquidity risk and foreign exchange risk and how the Company manages those risks.
(a) Credit risk
Credit
risk is the risk of an unexpected loss if a customer or counterparty to a financial instrument fails to meet its contractual obligations.
The Company regularly monitors credit risk exposure and takes steps to mitigate the likelihood of this exposure resulting in losses.
The Company’s exposure to credit risk currently relates to the financial assets at amortized cost in the table above. The Company
holds its available cash in amounts that are readily convertible to known amounts of cash and deposits its cash balances with financial
institutions that have an investment grade rating of at least “P-2” or the equivalent. This information is supplied by independent
rating agencies where available and, if not available, the Company uses publicly available financial information to ensure that it invests
its cash in creditworthy and reputable financial institutions. Once there are indicators that there is no reasonable expectation of recovery,
such financial assets are written off but are still subject to enforcement activity.
As
of December 31, 2021, trade accounts receivable for an amount of approximately $932 were with three counterparties of which $55 was past
due and impaired and fully provided for (2020 - $1,245 with three counterparties and $55 past due and impaired and fully provided for).
Generally,
the Company does not require collateral or other security from customers for trade accounts receivable; however, credit is extended following
an evaluation of creditworthiness. In addition, the Company performs ongoing credit reviews of all of its customers and determines expected
credit losses. On this basis, as of December 31, 2021, the Company has provided for all outstanding and unpaid amounts relating to its
operations before its licensing of MacrilenTM.
The
maximum exposure to credit risk approximates the amount recognized in the Company’s consolidated statement of financial position.
(b) Liquidity risk
Liquidity
risk is the risk that the Company will not be able to meet its financial obligations as they become due. As indicated in note 24, the
Company manages this risk through the management of its capital structure. It also manages liquidity risk by continuously monitoring
actual and projected cash flows.
A
portion of the Company’s cash is held in AEZS Germany, which is the counter-party to various license and distribution agreements
for the Company’s only approved product. In September 2019 and February, July and August of 2020 and February of 2021 the Company
completed financings resulting in total funding (net of transaction costs) of $55,905 (note 19). Net cash proceeds were deposited in
AEZS Canada accounts and such funds can be provided to its German subsidiary, if and when needed. During 2020, AEZS Germany signed agreements
with NOVO and CH whereby AEZS Germany received cash payments of €5,000 ($6,109) in fiscal 2020 and €1,000 ($1,209) in January
2021, respectively (note 5), and expects to use this cash to fund its operations directly.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
The
Board of Directors reviews and approves the Company’s operating and capital budgets, as well as any material transactions occurring
outside of the ordinary course of business. The Company has adopted an investment policy in respect of the safety and preservation of
its capital to ensure the Company’s liquidity needs are met. The instruments are selected with regard to the expected timing of
expenditures and prevailing interest rates.
All
of the Company’s financial liabilities except lease liabilities are current liabilities with expected settlement dates within one
year. The maturity analysis for lease liabilities is disclosed in note 17.
(c)
Foreign exchange risk
Entities
using the Euro as their functional currency
The
Company is exposed to foreign exchange risk due to its investments in foreign operations whose functional currency is the Euro. As of
December 31, 2021, if the US dollar had increased or decreased by 10% against the Euro, with all other variables held constant, net loss
for the year ended December 31, 2021 would have been lower or higher by approximately $300 (2020 - $110 and 2019 - $841).
The
Company operates in a single operating segment, being the biopharmaceutical segment.
Geographical
information
Revenues
by geographical area have been allocated to geographic regions based on the country of residence of the Company’s external customers
or licensees and are detailed as follows:
Summary of Revenues by Geographical Area
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
| |
$ | | |
$ | | |
$ | |
Switzerland | |
| 5,075 | | |
| 905 | | |
| — | |
Ireland | |
| — | | |
| 73 | | |
| 74 | |
Denmark | |
| 185 | | |
| 2,655 | | |
| 413 | |
Other | |
| — | | |
| 19 | | |
| 45 | |
Revenue | |
| 5,260 | | |
| 3,652 | | |
| 532 | |
Non-current
assets include restricted cash equivalents, right of use assets, property, plant and equipment, identifiable intangible assets, other
asset and goodwill and are detailed by geographical area as follows:
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
Summary of Non-current Assets by Geographical Area
| |
2021 | | |
2020 | |
| |
December 31, | |
| |
2021 | | |
2020 | |
| |
$ | | |
$ | |
Germany | |
| 9,212 | | |
| 9,341 | |
United States | |
| 70 | | |
| 50 | |
Non-current assets | |
| 9,282 | | |
| 9,391 | |
Major
customers representing 10% or more of the Company’s revenues in each of the last three years are as follows:
Summary of Major Customers
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
| |
$ | | |
$ | | |
$ | |
Company 1 | |
| 5,260 | | |
| 3,634 | | |
| 532 | |
The
following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common
shareholders.
Summary of Pertinent Data Relating to Computation of Basic and Diluted Net Loss Per Share
| |
2021 | | |
2020 | | |
2019 | |
| |
Years ended December 31, | |
| |
2021 | | |
2020 | | |
2019 | |
| |
$ | | |
$ | | |
$ | |
Net loss | |
| (8,368 | ) | |
| (5,118 | ) | |
| (6,042 | ) |
Basic weighted average number of shares outstanding | |
| 114,924,497 | | |
| 41,083,163 | | |
| 17,494,472 | |
Diluted weighted average number of shares outstanding | |
| 114,924,497 | | |
| 41,083,163 | | |
| 17,494,472 | |
Items excluded from the calculation of diluted net loss per share because the exercise price was greater than the average market price of the common shares or due to their anti-dilutive effect | |
| | | |
| | | |
| | |
Stock options and DSUs | |
| 1,509,368 | | |
| 679,400 | | |
| 953,557 | |
Share purchase warrants | |
| 11,441,213 | | |
| 44,901,366 | | |
| 6,629,144 | |
Anti-dilutive shares | |
| | | |
| | | |
| | |
Net
loss per share is calculated by dividing net loss by the weighted average number of shares outstanding during the relevant period. Diluted
weighted average number of shares reflects the dilutive effect of equity instruments, such as any “in the money” stock options,
DSUs and warrants. In periods with reported net losses, all stock options and warrants are deemed anti-dilutive such that basic net loss
per share and diluted net loss per share are equal, and thus “in the money” stock options and warrants have not been included
in the computation of net loss per share because to do so would be anti-dilutive.
Aeterna
Zentaris Inc.
Notes
to Consolidated Financial Statements
As
of December 31, 2021 and December 31, 2020 and for the years ended
December
31, 2021, 2020 and 2019
(in
thousands of US dollars, except share and per share data and where otherwise noted)
27. |
Commitments and contingencies |
Contractual
obligations and commitments as of December 31, 2021
Schedule of Expected Future Minimum Lease Payments
| |
Service and manufacturing | | |
R&D contracts | | |
TOTAL | |
| |
$ | | |
$ | | |
$ | |
Less than 1 year | |
| 1,085 | | |
| 2,252 | | |
| 3,337 | |
1 – 3 years | |
| 6 | | |
| 1,049 | | |
| 1,055 | |
4 – 5 years | |
| — | | |
| — | | |
| — | |
More than 5 years | |
| — | | |
| — | | |
| — | |
Total | |
| 1,091 | | |
| 3,301 | | |
| 4,392 | |
During
2021, the Company executed various agreements including in-licensing and similar arrangements with development partners (note 13). Such
agreements may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the
Company generally has the right to terminate these agreements at no penalty. The Company recognizes research and development milestones
as an intangible asset once it is committed to the payment, which is generally when the Company reaches a set point in the development
cycle.
Based on the closing exchange rates at December 31, 2021, the Company expects to pay $3,301, including $3,124 (€2.8 million), and $177
(£0.1 million), in R&D contracts and up to $8,937, including $7,386 (€6.5 million) and $1,551 (£1.2 million), in
R&D milestone payments and up to $32,942, including $31,255 (€27.6 million) and $1,687 (£1.3 million), in revenue related
milestone payments. The table below contains all potential R&D and revenue-related milestone payments that the Company may be required
to make under such agreements:
Schedule of R&D and Revenue Related Milestone Payments
| |
Future potential R&D milestone payments | | |
Future potential revenue milestone payments | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Less than 1 year | |
| 28 | | |
| — | | |
| 28 | |
1 – 3 years | |
| 113 | | |
| — | | |
| 113 | |
4 – 5 years | |
| 927 | | |
| — | | |
| 927 | |
More than 5 years | |
| 7,869 | | |
| 32,942 | | |
| 40,811 | |
Total | |
| 8,937 | | |
| 32,942 | | |
| 41,879 | |
The
table excludes any payments already capitalized in the consolidated statement of financial position. The future payments that are disclosed
represent contract payments and are not discounted and are not risk-adjusted. The development of any pharmaceutical product candidates
is a complex and risky process that may fail at any stage in the development process due to a number of factors. The timing of the payments
is based on the Company’s current best estimate of achievement of the relevant milestone.
Securities
class action lawsuit
On
March 9, 2020, the Company settled the previously disclosed class-action lawsuit against it pending in the US District Court for the
District of New Jersey. This settlement was approved by the US District Court for the District of New Jersey on June 3, 2021. The settlement
payment was funded entirely by the Company’s insurers. As no appeals were filed within the 30-day appeal period, this matter is
fully and finally settled.
Item 19. Exhibits