Dr. Gary S. Jacob, Chief
Executive Officer
(Name, telephone, e-mail and/or facsimile
number and address of company contact person)
Securities registered or to be registered
pursuant to Section 12(b) of the Act:
Securities registered
or to be registered pursuant to Section 12(g) of the Act: None
Securities for which
there is a reporting obligation pursuant to Section 15(d) of the Act: None
Indicate the number
of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by
the annual report:
Indicate by check
mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
If this report is
an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13
or 15 (d) of the Securities Exchange Act of 1934.
Indicate by check
mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act
of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90 days.
Indicate by check
mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§2232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Indicate by check
mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth
company” in Rule 12b-2 of the Exchange Act.
If an emerging growth
company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected
not to use the extended transition period for complying with any new or revised financial accounting standards† provided
pursuant to Section 13(a) of the Exchange Act. ☐
† The term
“new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board
to its Accounting Standards Codification after April 5, 2012.
Indicate by check
mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
If “Other” has been checked in response to the previous
question, indicate by check mark which financial statement item the registrant has elected to follow:
If this is an annual report, indicate by check mark whether
the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
We are a commercial
and clinical-stage biopharmaceutical company with a proprietary technology platform focused on the development and commercialization
of a novel class of specifically targeted polyclonal antibodies that we believe can address significant unmet medical needs. Our
oral polyclonal antibodies offer delivery within the gastrointestinal (“GI”) track and essentially do not cross into
the bloodstream, potentially leading to much improved safety and tolerability, without sacrificing efficacy. We believe that our
two lead drug candidates, IMM-124E and IMM-529, currently in clinical development, have the potential to transform the existing
treatment paradigms for travelers’ diarrhea and for C. difficile infections, respectively. We currently market our
flagship commercial product Travelan® in Australia, where it is a listed medicine on the Australian Register for Therapeutic
Goods, as an over-the-counter product indicated to reduce the risk of travelers’ diarrhea. We also market Travelan® in
Canada where it is licensed as a natural health product indicated to reduce the risk of travelers’ diarrhea, and presently
market Travelan® in the U.S. as a dietary supplement for digestive tract protection.
Our American Depositary
Shares (each, an “ADS” and, collectively the “ADSs”) and warrants (each, a “Warrant” and collectively,
the “Warrants”)) are listed on The NASDAQ Capital Market under the symbols “IMRN” and “IMRNW”,
respectively. Each ADS represents 40 of our ordinary shares, no par value. Each Warrant has a per ADS exercise price of US$10.00
and expires five years from the date of issuance. Our ordinary shares are also listed on the Australian Securities Exchange under
the symbol “IMC.”
Our consolidated financial
statements appearing in this annual report are prepared in Australian dollars and in accordance with the International Financial
Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our consolidated financial statements
appearing in this annual report comply with the IFRS.
In this annual report,
all references to “U.S. dollars” or “US$” are to the currency of the United States, and all references
to “Australian dollars”, “A$” or “AUD$” are to the currency of Australia. Unless otherwise
indicated or the context implies otherwise, all references to “we,” “us,” or “our” refers to
Immuron Limited, an Australian corporation.
Statements made in
this annual report concerning the contents of any contract, agreement or other document are summaries of such contracts, agreements
or documents and are not complete descriptions of all of their terms. If we filed any of these documents as an exhibit to this
annual report or to any registration statement or annual report that we previously filed, you may read the document itself for
a complete description of its terms.
Except for the historical
information contained in this annual report, the statements contained in this annual report are “forward-looking statements”
within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended, or the Exchange Act, and the Private Securities Litigation Reform Act of 1995, as amended, with respect to our
business, financial condition and results of operations. Such forward-looking statements reflect our current view with respect
to future events and financial results. We urge you to consider that statements which use the terms “anticipate,” “believe,”
“expect,” “plan,” “intend,” “estimate,” or
the negative of these terms or other comparable terminology. are intended to identify forward-looking statements. We remind
readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors
and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements,
or industry results, to be materially different from any future results, performance, levels of activity, or our achievements expressed
or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. Except as required by applicable law, including the securities laws of the United States,
we undertake no obligation to publicly release any update or revision to any forward-looking statements to reflect new information,
future events or circumstances, or otherwise after the date hereof. We have attempted to identify significant uncertainties and
other factors affecting forward-looking statements in the Risk Factors section that appears in Item 3.D. “Key Information-Risk
Factors.”
PART I
ITEM 1.
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2.
OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3.
KEY INFORMATION
A.
Selected Consolidated Financial Data
The
tables below as of and for the five years ended June 30, 2019 set forth selected consolidated financial data, which is derived
from our audited consolidated financial statements. The audited consolidated financial statements as of June 30, 2019 and, 2018
appear in this annual report. The consolidated income statement data for the years ended June 30, 2019, 2018 and 2017 and the consolidated
balance sheet data as of June 30, 2019 and 2018 are derived from our audited consolidated financial statements included in “ITEM
18: Financial Statements”. The consolidated financial data as of June 30, 2017, 2016 and 2015 and for the years ended June
30, 2016 and 2015 have been derived from our audited consolidated financial statements which are not included in this annual report.
The selected consolidated financial data set forth below should be read in conjunction with and is qualified entirely by reference
to Item 5. “Operating and Financial Review and Prospects” and our consolidated financial statements and notes thereto
included elsewhere in this annual report.
Statement of Comprehensive Income:
|
|
For the year ended June 30,
|
|
|
|
2019
AUD$
|
|
|
2018
AUD$
|
|
|
2017
AUD$
|
|
|
2016
AUD$
|
|
|
2015
AUD$
|
|
Consolidated Statement of Profit or Loss and Other Comprehensive Income Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from contracts with customers
|
|
|
2,387,426
|
|
|
|
1,842,909
|
|
|
|
1,396,197
|
|
|
|
1,001,077
|
|
|
|
1,002,380
|
|
Cost of Goods Sold
|
|
|
(667,371
|
)
|
|
|
(418,693
|
)
|
|
|
(337,546
|
)
|
|
|
(301,435
|
)
|
|
|
(316,128
|
)
|
Gross Profit
|
|
|
1,720,055
|
|
|
|
1,424,216
|
|
|
|
1,058,651
|
|
|
|
699,642
|
|
|
|
686,252
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income
|
|
|
532,050
|
|
|
|
1,849,163
|
|
|
|
1,605,987
|
|
|
|
1,526,872
|
|
|
|
1,494,387
|
|
Other gains/(losses) – net
|
|
|
38,413
|
|
|
|
95,167
|
|
|
|
(375,479
|
)
|
|
|
(221,112
|
)
|
|
|
(70,190
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
|
(5,014,128
|
)
|
|
|
(3,412,576
|
)
|
|
|
(3,109,845
|
)
|
|
|
(4,337,686
|
)
|
|
|
(1,654,026
|
)
|
Research and development expenses
|
|
|
(1,044,528
|
)
|
|
|
(2,257,224
|
)
|
|
|
(4,630,674
|
)
|
|
|
(3,623,961
|
)
|
|
|
(3,018,294
|
)
|
Selling and marketing expenses
|
|
|
(864,644
|
)
|
|
|
(686,714
|
)
|
|
|
(1,271,526
|
)
|
|
|
(751,805
|
)
|
|
|
(226,583
|
)
|
Operating loss
|
|
|
(4,632,782
|
)
|
|
|
(2,987,968
|
)
|
|
|
(6,722,886
|
)
|
|
|
(6,708,050
|
)
|
|
|
(2,788,454
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
|
|
|
39
|
|
|
|
1,238
|
|
|
|
8,386
|
|
|
|
12,143
|
|
|
|
96,634
|
|
Finance expenses
|
|
|
—
|
|
|
|
(24,199
|
)
|
|
|
(89,654
|
)
|
|
|
(372,860
|
)
|
|
|
—
|
|
Finance costs - net
|
|
|
39
|
|
|
|
(22,961
|
)
|
|
|
(81,268
|
)
|
|
|
(360,717
|
)
|
|
|
96,634
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax
|
|
|
(4,632,743
|
)
|
|
|
(3,010,929
|
)
|
|
|
(6,804,154
|
)
|
|
|
(7,068,767
|
)
|
|
|
(2,691,820
|
)
|
Income Tax Expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Loss for the period
|
|
|
(4,632,743
|
)
|
|
|
(3,010,929
|
)
|
|
|
(6,804,154
|
)
|
|
|
(7,068,767
|
)
|
|
|
(2,691,820
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items that may be reclassified to profit or loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange differences on translation of foreign operations
|
|
|
61,846
|
|
|
|
(79,599
|
)
|
|
|
40,017
|
|
|
|
8,846
|
|
|
|
(12,581
|
)
|
Total Comprehensive Loss for the Period
|
|
|
(4,570,897
|
)
|
|
|
(3,090,528
|
)
|
|
|
(6,764,137
|
)
|
|
|
(7,059,921
|
)
|
|
|
(2,704,401
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share, basic and diluted (in cents per share)
|
|
|
(3.20
|
)
|
|
|
(2.25
|
)
|
|
|
(6.40
|
)
|
|
|
(9.248
|
)
|
|
|
(3.592
|
)
|
Weighted-average number of shares outstanding, basic and diluted
|
|
|
144,740,535
|
|
|
|
133,660,556
|
|
|
|
105,866,110
|
|
|
|
76,435,993
|
|
|
|
74,935,902
|
|
|
|
As of June 30,
|
|
|
|
2019
AUD$
|
|
|
2018
AUD$
|
|
|
2017
AUD$
|
|
|
2016
AUD$
|
|
|
2015
AUD$
|
|
Consolidated Statement of Financial Position Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
5,119,887
|
|
|
|
4,727,430
|
|
|
|
3,994,924
|
|
|
|
2,290,639
|
|
|
|
3,116,074
|
|
Total current assets
|
|
|
6,682,444
|
|
|
|
7,050,437
|
|
|
|
8,267,654
|
|
|
|
8,809,421
|
|
|
|
5,998,898
|
|
Total assets
|
|
|
8,561,647
|
|
|
|
9,242,688
|
|
|
|
8,286,491
|
|
|
|
8,827,484
|
|
|
|
6,018,412
|
|
Total current liabilities
|
|
|
1,195,531
|
|
|
|
803,338
|
|
|
|
1,711,565
|
|
|
|
3,886,921
|
|
|
|
1,207,810
|
|
Total liabilities
|
|
|
1,210,511
|
|
|
|
803,338
|
|
|
|
1,711,565
|
|
|
|
3,886,921
|
|
|
|
1,207,810
|
|
Total equity
|
|
|
7,351,136
|
|
|
|
8,439,350
|
|
|
|
6,574,926
|
|
|
|
4,940,563
|
|
|
|
4,810,602
|
|
B.
Capitalization and Indebtedness
Not applicable.
C.
Reasons for the Offer and Use of Proceeds
Not applicable.
D.
Risk Factors
Investing in our ADSs involves a high
degree of risk and uncertainty. You should carefully consider the risks and uncertainties described below before investing in our
ADSs. Additional risks and uncertainties not presently known to us or that we believe to be immaterial may also adversely affect
our business. If any of the following risks actually occurs, our business, prospects, financial condition and results of operations
could be harmed. In that case, the price of our ADSs could decline, and you could lose all or part of your investment.
Risks Related to Our Financial Condition
As a company predominantly focused on
the research and development activities of our existing patent portfolio pipeline we have incurred operating losses; we expect
to continue to incur operating losses for the foreseeable future and may never achieve or maintain profitability.
We have
incurred losses in every period since we began operations in 1994 and we have reported net losses of A$4,632,743,
A$3,010,929, A$6,804,154, A$7,068,767 and A$2,691,820 during the fiscal years ended June 30, 2019, 2018, 2017, 2016 and 2015,
respectively. As of June 30, 2019, our accumulated deficit was A$56,860,523. We are budgeting to continue to incur additional
operating losses for the next several years as we expand our research and development activities for the treatment of
infectious diseases, commence new trials for our product candidate IMM-529 for C. difficile, and
potential other assets/indications. We may never be able to achieve or maintain profitability.
Our actual cash requirements may vary materially
from those now planned and will depend upon numerous factors, including:
|
●
|
the continued progress of our research and development programs;
|
|
●
|
the timing, scope, results and costs of pre-clinical studies and clinical trials;
|
|
●
|
the cost, timing and outcome of regulatory submissions and approvals;
|
|
●
|
determinations as to the commercial potential of our product candidates;
|
|
●
|
spending on our marketed assets;
|
|
●
|
our ability to successfully expand our contract manufacturing services;
|
|
●
|
our ability to establish and maintain collaborative arrangements; and
|
|
●
|
the status and timing of competitive developments.
|
As of June 30,
2019, we had A$5,119,887 in cash and cash equivalents. Developing prescription products is expensive and we will need to
secure additional financing in order to continue to meet our longer-term business objectives, including advancement of our
research and development programs. We may also require additional funds to pursue regulatory clearances, defend our
intellectual property rights, establish commercial scale manufacturing facilities, develop marketing and sales capabilities
and fund operating expenses. We intend to seek such additional funding through public or private financings and/or through
licensing of our assets or strategic alliances or other arrangements with corporate partners. The global economic climate
could adversely impact our ability to obtain such funding, license our assets or enter into alliances or other arrangements
with corporate partners. Any shortfall in funding could result in our having to curtail or cease our operations, including
our research and development activities, which would be expected to adversely affect our business, financial condition and
results of operations.
We have never generated any revenue
from prescription product sales and this area of our business may never be profitable.
Our ability to generate significant revenue
from prescription products and achieve profitability depends on our ability to, alone or with strategic collaboration partners,
successfully complete the development of and obtain the regulatory approvals for our prescription product candidates, to manufacture
sufficient supply of our product candidates, to establish a sales and marketing organization or suitable third-party alternative
for the marketing of any approved products and to successfully commercialize any approved products on commercially reasonable terms.
All of these activities will require us to raise sufficient funds to finance business activities. Currently, we do not expect any
milestone payments from our collaborative partners to be significant in the foreseeable future. However, we are actively pursuing
potential partner collaboration. In addition, we do not anticipate generating revenue from commercializing product candidates for
the foreseeable future, if ever.
Our ability to generate future revenues
from commercializing our intellectual property (“IP”) assets depends heavily on our success in:
|
●
|
establishing proof of concept in preclinical studies and clinical trials for our product candidates;
|
|
●
|
successfully completing clinical trials of our product candidates;
|
|
●
|
obtaining regulatory and marketing approvals for product candidates for which we complete clinical
trials;
|
|
●
|
maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing
on intellectual property of third parties;
|
|
●
|
establishing and maintaining successful licenses, collaborations and alliances with third parties;
|
|
●
|
developing a sustainable, scalable, reproducible and transferable manufacturing process for our
product candidates;
|
|
●
|
establishing and maintaining supply and manufacturing relationships with third parties that can
provide products and services adequate, in amount and quality, to support clinical development and commercialization of our product
candidates, if approved;
|
|
●
|
launching and commercializing any product candidates for which we obtain regulatory and marketing
approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and distribution
infrastructure;
|
|
●
|
obtaining market acceptance of any product candidates that receive regulatory approval as viable
treatment options;
|
|
●
|
obtaining favorable coverage and reimbursement rates for our products from third-party payors;
|
|
●
|
addressing any competing technological and market developments;
|
|
●
|
identifying and validating new product candidates; and
|
|
●
|
negotiating favorable terms in any collaboration, licensing or other arrangements into which we
may enter.
|
The process of developing
product candidates for the prevention and treatment of gut mediated pathogens contains a number of inherent risks and uncertainties, including
clinical and regulatory risks.
Even if one or more
of our product candidates is approved for commercial sale, we may incur significant costs associated with commercializing any approved
product candidate. As one example, our expenses could increase beyond expectations if we are required by the Food and Drug Administration,
or FDA, or other regulatory agencies, domestic or foreign, to perform clinical and other studies in addition to those that we currently
anticipate. Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may
need to obtain additional funding to continue operations, which could have an adverse effect on our business, financial condition,
results of operations and prospects.
We are a development stage company
and our success is uncertain.
We are a clinical
development stage company and our pharmaceutical products are designed to treat a range of infectious diseases. Other than our
Travelan and Protectyn products, we have not sufficiently advanced the development of any of our products, including our current
lead product candidate, IMM-124E, to market or generate revenues from their commercial application. Our current or any future
product candidates, if successfully developed, may not generate sufficient or sustainable revenues to enable us to be profitable.
We receive Australian government research
and development income tax concession refunds. If our research and development expenditures are not deemed eligible for the refund,
we may encounter difficulties in the funding of future research and development projects, which could harm our operating results.
We have historically
received, and expect to continue to receive, refunds from the Australian Federal Government’s Research and Development Tax
Incentive program, under which the government provides a cash refund for the 43.5% of eligible research and development expenditures
by small to medium size Australian entities during the year ended June 30, 2019, which are defined as Australian entities with
less than A$20 million in revenue, having a tax loss.
The Research
and Development Tax Incentive refunds are made by the Australian federal government for eligible research and development
purposes based on the filing of an annual application and subsequent income tax returns for the fiscal year. We recognized
Research and Development Tax Concession Incentive refunds in the fiscal years ended June 30, 2018, June 30, 2017, June 30,
2016 and June 30, 2015 of A$1,849,123 A$1,575,315, A$1,512,840, and A$1,478,581, respectively, and we have recognized
A$531,005 for the fiscal year ended June 30, 2019, that includes an estimate of the receipt for the claim yet to be
filed.
These refunds are
available to fund our ongoing activities including our research and development activities in Australia, as well as activities
in Europe, the U.S. and Israel to the extent such overseas-based expenses relate to our activities in Australia, do not exceed
half the expenses for the relevant activities and are approved by the Australian government. To the extent our research and development
expenditures are deemed to be “ineligible,” then our refunds would decrease. In addition, the Australian government
may in the future modify the requirements of or reduce the amounts or percentage claimable in turn reducing the refunds available
under the Research and Development Tax Incentive program, or discontinue the incentive program entirely. Any such change in the
Research and Development Tax Incentive program would have a negative effect on our future cash flows and our potential associated
future expenditures.
Risks Related to Our Business
We are faced with uncertainties related
to our research.
Our research programs
are based on scientific hypotheses and experimental approaches that may not lead to desired results. In addition, the timeframe
for obtaining proof of principle and other results may be considerably longer than originally anticipated, or may not be possible
given time, resource, financial, strategic and collaborator scientific constraints. Success in one stage of testing is not necessarily
an indication that the particular program will succeed in later stages of testing and development. It is not possible to predict
whether any of the drugs designed for these programs will prove to be safe, effective, and suitable for human use. Each drug will
require additional research and development, scale-up, formulation and extensive clinical testing in humans. Unsatisfactory results
obtained from a particular study relating to a program may cause us to abandon our commitment to that program or to the lead compound
or product candidate being tested. The discovery of toxicities, lack of sufficient efficacy, unacceptable pharmacology, inability
to increase scale of manufacture, market attractiveness, regulatory hurdles, competition, as well as other factors, may make our
targets, lead therapies or product candidates unattractive for further development or unsuitable for human use, and we may abandon
our commitment to that program, target, lead therapy or product candidate. Any delay in obtaining or failure to obtain required
approvals could materially and adversely affect our ability to generate revenue from the particular product candidate, which likely
would result in significant harm to our financial position and adversely impact the price of the ADS. Furthermore, any regulatory
approval to market a product may be subject to limitations on the indicated uses for which we may market the product. These limitations
may limit the size of the market for the product.
Clinical trials are expensive and
time consuming, and their outcome is uncertain.
In order to obtain
approvals to market a new drug product, we or our potential partners must demonstrate proof of safety and efficacy in humans. To
meet these requirements, we or our potential partners will have to conduct extensive preclinical testing and “adequate and
well- controlled” clinical trials. Conducting clinical trials is a lengthy, time-consuming and expensive process. The length
of time may vary substantially according to the type, complexity, novelty and intended use of the product candidate, and often
can be several years or more per trial. Even if we obtain positive results from preclinical or initial clinical trials, we may
not achieve the same success in future trials. Clinical trials may not demonstrate statistically sufficient safety and effectiveness
to obtain the requisite regulatory approvals for product candidates employing our technology. The failure of clinical trials to
demonstrate safety and efficacy for a particular desired indication could harm development of that product candidate for other
indications as well as other product candidates.
We expect to commence
new clinical trials from time to time in the course of our business as our product development work continues. Any change in, or
termination of, our clinical trials could materially harm our business, financial condition and results of operations.
We rely on third parties to conduct
our preclinical studies and clinical trials. If these third parties do not meet our deadlines or otherwise conduct the studies
as required, we may be delayed in progressing, or ultimately may not be able to progress, product candidates to clinical trials,
our clinical development programs could be delayed or unsuccessful, and we may not be able to commercialize or obtain regulatory
approval for our product candidates when expected, or at all.
We do not have the
ability to conduct all aspects of our preclinical testing or clinical trials ourselves. We are dependent on third parties to conduct
the clinical trials for IMM-124E and IMM-529, and preclinical studies for our other product candidates, and therefore the timing
of the initiation and completion of these trials and studies is reliant on third parties and may occur at times substantially different
from our estimates or expectations.
If we cannot contract
with acceptable third parties on commercially reasonable terms, or if these third parties do not carry out their contractual duties,
satisfy legal and regulatory requirements for the conduct of preclinical studies or clinical trials or meet expected deadlines,
our clinical development programs could be delayed or discontinued.
We may experience delays in one or
any of our clinical trial programs that could have an adverse effect on our business and operations, and future commercialization
opportunities of our clinical pipeline.
To the extent we do
our best to plan and mitigate against known risk aspects of our clinical trial programs, we do not know with any certainty whether
the planned clinical trials will begin on time, whether we will complete any of our clinical trials on schedule, or at all, or
within the forecasted budget. Our ability to commence and complete clinical trials may be delayed by many factors, including, but
not limited to:
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government or regulatory delays, including delays in obtaining approvals from applicable hospital
ethics committees and internal review boards;
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slower than expected patient enrollment;
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our inability to manufacture sufficient quantities of our new proprietary compound or our other
product candidates or matching controls;
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unforeseen safety issues; or
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lack of efficacy or unacceptable toxicity during the clinical trials or non-clinical studies.
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Patient enrollment
is a function of, among other things, the nature of the clinical trial protocol, the existence of competing protocols, the size
and longevity of the target patient population, and the availability of patients who comply with the eligibility criteria for the
clinical trial. Delays in planned patient enrollment may result in increased costs, delays or termination of the clinical trials.
Moreover, we rely on third parties such as clinical research organizations to assist us in clinical trial management functions
including clinical trial database management, statistical analyses, site management and monitoring. Any failure by these third
parties to perform under their agreements with us may cause the trials to be delayed or result in a failure to complete the trials.
If we experience delays
in testing, in gaining the receipt of necessary approvals, or if we need to perform more, larger or more complex clinical trials
than planned, our product development costs may increase. Significant delays could adversely affect the commercial prospects of
our product candidates and our business, financial condition and results of operations.
We may not be successful in obtaining
or maintaining other rights necessary for the development of our pipeline through acquisitions and in-licenses.
Our product candidates
may require specific formulations to work effectively, and efficiently, and rights to such formulations may be held by others.
We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property
rights from third parties that we identify on terms that we find acceptable, or at all. The licensing and acquisition of third-party
intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to
license or acquire third-party intellectual property rights that we may consider attractive. These established companies may have
a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.
For example, we sometimes
collaborate with U.S. and foreign academic institutions to accelerate our preclinical research or development under written agreements
with these institutions. Typically, these institutions provide us with an option to negotiate a license to any of the institution’s
rights in technology resulting from the collaboration. Regardless of such right of first negotiation for intellectual property,
we may be unable to negotiate a license within the specified time frame or under terms that are acceptable to us. If we are unable
to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our ability to pursue
our program.
In addition, companies
that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire
third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment. If we are
unable to successfully obtain rights to required third-party intellectual property rights, our business, financial condition and
prospects for growth could suffer.
We rely on research institutions to
conduct our clinical trials and we may not be able to secure and maintain research institutions to conduct our future trials.
Our reliance upon
research institutions, including public and private hospitals and clinics, provides us with less control over the timing and cost
of clinical trials, clinical study management personnel and the ability to recruit subjects. If we are unable to reach agreements
with suitable research institutions on acceptable terms, or if any resulting agreement is terminated, we may be unable to secure,
maintain, or quickly replace the research institution with another qualified institution on acceptable terms.
We grant licenses to our collaborators
to use our hyper-immune colostrum technology exclusively for the development of product candidates for certain conditions.
We may out-license
to our collaborators the right to use our hyper-immune colostrum technology for the development of product candidates for certain
conditions, so long as our collaborators comply with certain requirements. That means that once our technology is licensed to a
collaborator for a specified condition, we are generally prohibited from developing product candidates for that condition and from
licensing to any third party for that condition. The limitations imposed by these exclusive licenses could prevent us from expanding
our business and increasing our development of product candidates with new collaborators, both of which could adversely affect
our business and results of operations.
We may not be able to complete the
development of IMM-124E, IMM-529 or develop other pharmaceutical products.
We may not be able
to progress with the development of our current, or any future, pharmaceutical product candidates to a stage that will attract
a suitable collaborative partner for the development of any current or future pharmaceutical product candidates. The projects initially
specified in connection with any such collaboration and any associated funding may change or be discontinued as a result of changing
interests of either the collaborator or us, and any such change may change the budget for the projects under the collaboration.
Additionally, our research may not lead to the discovery of additional product candidates, and any of our current and future product
candidates may not be successfully developed, prove to be safe and efficacious in clinical trials, meet applicable regulatory standards
and receive regulatory approval, be capable of being produced in commercial quantities at reasonable costs, or be successfully
or profitably marketed, either by us or a collaborative partner. The products we develop may not be able to penetrate the potential
market for a particular therapy, or indication, or gain market acceptance among health care providers, patients and third-party
payers. We cannot predict if or when the development of IMM-124E, IMM-529 or any future pharmaceutical product will be completed
or commercialized, whether funded by us, as part of a collaboration or through a grant.
We may need to prioritize the development
of our most promising candidates at the expense of the development of other products.
We may need to prioritize
the allocation of development resources and/or funds towards what we believe to be our most promising product or products. The
nature of the drug development process is such that there is a constant availability of new information and data that could positively
or adversely affect any of our products in development. We cannot predict how such new information and data may impact in the future
the prioritization of the development of our current or future product candidates or that any of our products, regardless of its
development stage or the investment of time and funds in its development, will continue to be funded or developed.
Our research and development efforts
will be seriously jeopardized if we are unable to retain key personnel and cultivate key academic and scientific collaborations.
Our future success
depends to a large extent on the continued services of our senior management and key scientific personnel, including Dr. Gary
S Jacob who is currently our Chief Executive Officer. The loss of the services from Dr. Jacob could negatively affect our
business.
Competition among
biotechnology and pharmaceutical companies for qualified employees is intense, including competition from larger companies with
greater resources, and we may not be able to continue to attract and retain qualified management, technical and scientific personnel
critical to our success. Our success is highly dependent on our ability to develop and maintain important relationships with leading
academic institutions and scientists who conduct research at our request or assist us in formulating our research and development
strategies. These academic and scientific collaborators are not our employees and may have commitments to, or consulting or advisory
contracts with, other entities that may limit their availability to us. In addition, these collaborators may have arrangements
with other companies to assist such companies in developing technologies that may prove competitive to ours.
If we are unable to successfully keep
pace with technological change or with the advances of our competitors, our technology and products may become obsolete or non-competitive.
The biotechnology
and pharmaceutical industries are subject to rapid and significant technological change. Our competitors are numerous and include
major pharmaceutical companies, biotechnology firms, universities and other research institutions. These competitors may develop
technologies and products that are more effective than any that we are developing, or which would render our technology and products
obsolete or non-competitive. Many of these competitors have greater financial and technical resources and manufacturing and marketing
capabilities than we do. In addition, many of our competitors have much more experience than we do in pre-clinical testing and
human clinical trials of new or improved drugs, as well as in obtaining regulatory approvals.
We know that competitors
are developing or manufacturing various technologies or products for the treatment of diseases that we have targeted for product
development. Some of these competitive products use therapeutic approaches that compete directly with our product candidates. Our
ability to further develop our products may be adversely affected if any of our competitors were to succeed in obtaining regulatory
approval for their competitive products sooner than us.
Acceptance of our products in the
marketplace is uncertain, and failure to achieve market acceptance will negatively impact our business and operations.
Our current or future
products may not achieve market acceptance even if they are approved by regulatory authorities. The degree of market acceptance
of such products will depend on a number of factors, including:
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the receipt and timing of regulatory approvals for the uses that we are studying;
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the establishment and demonstration to the medical community of the safety, clinical efficacy or
cost-effectiveness of our product candidates and their potential advantages over existing therapeutics and technologies; and
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the pricing and reimbursement policies of governments and third-party payors.
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Physicians, patients, third-party
payors or others in the medical community may not be receptive to our product candidates, and we may not generate any future revenue
from the sale or licensing of our product candidates.
Even if we obtain
approval for a product candidate, we may not generate or sustain revenue from sales of the product if the product cannot be sold
at a competitive cost or if it fails to achieve market acceptance by physicians, patients, third-party payors or others in the
medical community. These market participants may be hesitant to adopt a novel treatment based on hyper-immune colostrum technology,
and we may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement
for, any product candidates developed by us or our existing or future collaborators. Market acceptance of our product candidates
will depend on, among other factors:
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the safety and efficacy of our product candidates;
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our ability to offer our products for sale at competitive prices;
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the relative convenience and ease of administration of our product candidates;
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the prevalence and severity of any adverse side effects associated with our product candidates;
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the terms of any approvals and the countries in which approvals are obtained;
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limitations or warnings contained in any labeling approved by the FDA or comparable foreign regulatory
authorities;
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conditions upon the approval imposed by FDA or comparable foreign regulatory authorities, including,
but not limited to, a Risk Evaluation and Mitigation Strategy (“REMS”);
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the willingness of patients to try new treatments and of physicians to prescribe these treatments;
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the availability of government and other third-party payor coverage and adequate reimbursement;
and
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availability of alternative effective treatments for the disease indications our product candidates
are intended to treat and the relative risks, benefits and costs of those treatments.
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Additional risks apply
in relation to any disease indications we pursue which are classified as rare diseases and allow for orphan drug designation by
regulatory agencies in major commercial markets, such as the U.S. or European Union. If pricing is not approved or accepted in
the market at an appropriate level for any approved product for which we pursue and receive an orphan drug designation, such product
may not generate enough revenue to offset costs of development, manufacturing, marketing and commercialization despite any benefits
received from the orphan drug designation, such as market exclusivity, for a period of time. Orphan exclusivity could temporarily
delay or block approval of one of our products if a competitor obtains orphan drug designation for its product first. However,
even if we obtain orphan exclusivity for one of our products upon approval, our exclusivity may not block the subsequent approval
of a competitive product that is shown to be clinically superior to our product.
Market size is also
a variable in disease indications not classified as rare. Our estimates regarding potential market size for any indication may
be materially different from what we discover to exist at the time we commence commercialization, if any, for a product, which
could result in significant changes in our business plan and have a material adverse effect on our business, financial condition,
results of operations and prospects.
We face competition from entities
that have developed or may develop product candidates for our target disease indications, including companies developing novel
treatments and technology platforms based on modalities and technology similar to ours. If these companies develop technologies
or product candidates more rapidly than we do or their technologies, including delivery technologies, are more effective, our ability
to develop and successfully commercialize product candidates may be compromised.
The development and
commercialization of pharmaceutical products is highly competitive. We compete with a variety of multinational pharmaceutical companies
and specialized biotechnology companies, as well as technology being developed at universities and other research institutions.
Our competitors have developed, are developing or could develop product candidates and processes competitive with our product candidates.
Competitive therapeutic treatments include those that have already been approved and accepted by the medical community, patients
and third-party payors, and any new treatments that enter the market.
We believe that a
significant number of products are currently under development, and may become commercially available in the future, for the treatment
of conditions for which we are developing, and may in the future try to develop, product candidates. We are aware of multiple companies
that are working in the field of fatty-liver diseases and C. difficile therapeutics, including Intercept, Gilead, Genfit,
Tobira, Galmed which are all developing therapeutics for fatty-liver diseases and Seres, Synthetic Biotechnology and Assembly Biotechnology
for C. difficile.
We have limited large scale manufacturing
experience with our product candidates. Delays in manufacturing sufficient quantities of such materials to the required standards
for pre-clinical and clinical trials may negatively impact our business and operations.
While we have extensive
experience in producing therapeutic colostrum, we may not be able to manufacture sufficient quantities of our product candidates
in a cost-effective or timely manner. Manufacturing includes the production, formulation and stability testing of an active pharmaceutical
ingredient and its formulation into pharmaceutical products, such as capsules or tablets. Any delays in production would delay
our pre-clinical and human clinical trials, which could adversely affect our business, financial condition and operations.
We may be required
to enter into contracting arrangements with third parties to manufacture our product candidates for large-scale, pre- clinical
and/or clinical trials. We may not be able to make the transition from laboratory-scale to development-scale or from development-scale
to commercial production. We may need to develop additional manufacturing resources, enter into collaborative arrangements with
other parties who have established manufacturing capabilities, or have third parties manufacture our products on a contract basis.
We may not have access on acceptable terms to the necessary and substantial financing that would be required to scale-up production
and develop effective commercial manufacturing processes and technologies. We may not be able to enter into collaborative or contracting
arrangements on acceptable terms with parties that will meet our requirements for quality, quantity and timeliness.
If we are not able
to obtain an acceptable purity for any product candidate or an acceptable product specification, pre-clinical and clinical trials
would be delayed, which could adversely affect the priority of the development of our product candidates, our business, financial
condition and results of operations. This may adversely impact the cost of goods or feasibility of market scale.
Our product candidates and the process
for administering our product candidates may cause undesirable side effects or have other properties that could delay or prevent
their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following
any potential marketing approval.
Treatment with our
product candidates may produce undesirable side effects or adverse reactions or events. If any such adverse events occur, our clinical
trials could be suspended or discontinued, and the FDA or comparable foreign regulatory authorities could order us to cease further
development or deny approval of our product candidates for any or all targeted indications. The product-related side effects could
affect patient recruitment or the ability of enrolled patients to complete the trial. If we elect or are required to delay, suspend
or discontinue any clinical trial of any of our product candidates, the commercial prospects of such product candidates will be
harmed and our ability to generate product revenues from any of these product candidates will be delayed or eliminated. Any of
these occurrences may harm our business, financial condition and prospects significantly.
We currently depend upon a sole manufacturer
of our lead compound and on a sole manufacturer to produce finished drug products and could incur significant costs and delays
if we are unable to promptly find a replacement for either of them.
At this time, we are
relying on a single manufacturer to develop Good Manufacturing Practice (“GMP”), processes for our lead compound. Our
lead compound, IMM-124E, is manufactured by Synlait Milk Limited based in New Zealand. This manufacturer enables efficient large-scale
manufacture of colostrum to provide drug substance for our current and prospective trials in fatty-liver patients. We also rely
on contract manufacturers such as Mayne Pharma International, to produce all of our marketed products and Pharmaceutical Packaging Professionals
and Australian Blister Sealing to package our investigational drug products. We are actively seeking additional and back-up manufacturers
but may be unsuccessful in our efforts or may incur material additional costs and substantial delays.
The failure to establish sales, marketing
and distribution capability would materially impair our ability to successfully market and sell our pharmaceutical products.
We currently have
limited experience in the marketing, sales or distribution of pharmaceutical products. If we develop any commercially marketable
pharmaceutical products and decide to perform our own sales and marketing activities, we will require additional resources and,
will need to hire sales and marketing personnel which will require additional capital. Qualified personnel may not be available
in adequate numbers or at a reasonable cost. Furthermore, our sales staff may not achieve success in their marketing efforts. Alternatively,
we may be required to enter into marketing arrangements with other parties who have established appropriate marketing, sales and
distribution capabilities. We may not be able to enter into marketing arrangements with any marketing partner, or if such arrangements
are established, our marketing partners may not be able to commercialize our products successfully. Other companies offering similar
or substitute products may have well-established and well-funded marketing and sales operations in place that will allow them to
market their products more effectively. Failure to establish sufficient marketing capabilities would materially impair our ability
to successfully market and sell our pharmaceutical products.
If healthcare insurers and other organizations
do not pay for our products, or impose limits on reimbursement, our future business may suffer.
The drugs we hope
to develop may be rejected by the marketplace due to many factors, including cost. The continuing efforts of governments, insurance
companies, health maintenance organizations and other payors of healthcare costs to contain or reduce healthcare costs may affect
our future revenues and profitability and those of our potential customers, suppliers and collaborative partners, as well as the
availability of capital. In Australia and certain foreign markets, the pricing or profitability of prescription pharmaceuticals
is already subject to government control. We expect initiatives for similar government control at both the state and federal level
to continue in the U.S. and elsewhere. The adoption of any such legislative or regulatory proposals could adversely affect our
business and prospects.
Our ability to commercially
exploit our products successfully will depend in part on the extent to which reimbursement for the cost of our products and related
treatment will be available from government health administration authorities, private health coverage insurers and other organizations.
Third-party payors, such as government and private health insurers, are increasingly challenging the price of medical products
and services. Uncertainty exists as to the reimbursement status of newly approved health care products and in foreign markets,
including the U.S. If third-party coverage is not available to patients for any of the products we develop, alone or with collaborators,
the market acceptance of these products may be reduced, which may adversely affect our future revenues and profitability. In addition,
cost containment legislation and reductions in government insurance programs may result in lower prices for our products and could
materially adversely affect our ability to operate profitably.
We may be exposed to product liability
claims, which could harm our business.
The testing, marketing,
and sale of human health care products also entail the inherent risk of product liability. We may incur substantial liabilities
or be required to limit development or commercialization of our products if we cannot successfully defend ourselves against product
liability claims. We have historically obtained no fault compensation insurance for our clinical trials and will continue to obtain
similar coverage for all future clinical trials. Such coverage may not be available in the future on acceptable terms, or at all.
This may result in our inability to pursue further clinical trials or to obtain adequate protection in the event of a successful
claim. We may not be able to obtain product liability insurance in the event of the commercialization of a product or such insurance
may not be available on commercially reasonable terms. Even if we have adequate insurance coverage, product liability claims, or
recalls could result in negative publicity or force us to devote significant time, attention and financial resources to those matters.
Breaches of network or information
technology security, natural disasters or terrorist attacks could have an adverse effect on our business.
Cyber-attacks or other
breaches of network or information technology (“IT”) security, natural disasters, terrorist acts or acts of war may
cause equipment failures or disrupt our research and development operations. In particular, both unsuccessful and successful cyber-attacks
on companies have increased in frequency, scope and potential harm in recent years. Such an event may result in our inability,
or the inability of our partners, to operate the research and development facilities, which even if the event is for a limited
period of time, may result in significant expenses and/or significant damage to our experiments and trials. In addition, a failure
to protect employee confidential data against breaches of network or IT security could result in damage to our reputation. Any
of these occurrences could adversely affect our results of operations and financial condition.
To date, we have not
had any such occurrence of cyber-attacks to our networks and IT infrastructure through cyber-attack, malware, computer viruses
and other means of unauthorized access or other cyber incidents, individually or in the aggregate; however, should this occur in
the future, it may result in a material impact to our operations or financial condition.
We expect to expand our drug development,
regulatory and business development capabilities, and as a result, we may encounter difficulties in managing our growth, which
could disrupt our operations.
We expect to experience
significant growth in the number of our employees and consultants and the scope of our operations, particularly in the areas of
drug development, regulatory affairs and business development. To manage our anticipated future growth, we must continue to implement
and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional
qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company
with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional
qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development
resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations and have a
materially adverse effect on our business.
Positive results from preclinical studies
of our product candidates are not necessarily predictive of future results of planned clinical trials of our product candidates.
Positive results
in preclinical proof-of-concept and animal studies of our product candidates may not result in positive results in clinical trials
in humans. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials
after achieving positive results in preclinical development or early stage clinical trials, and we cannot be certain that we will
not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials
were underway or safety or efficacy observations made in clinical trials, including adverse events. Moreover, preclinical and
clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates
performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory authority
approval. If we fail to produce positive results in our clinical trials of our product candidates, the development timeline and
regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business and financial
prospects, would be negatively impacted.
Our future prospects may also be dependent
on our or our collaborators’ ability to successfully develop a pipeline of additional product candidates, and we and our
collaborators may not be successful in efforts to use our platform technologies to identify or discover additional product candidates.
The success of our
business depends primarily upon our ability to identify, develop and commercialize products based on our platform technology. We
only have two product candidates currently in clinical development, IMM-124E and IMM-529.
Our other product
candidates derived from our platform technology may not successfully complete IND-enabling studies, and our research programs may
fail to identify other potential product candidates for clinical development for a number of reasons. Our and our collaborators’
research methodology may be unsuccessful in identifying potential product candidates, our potential product candidates may not
demonstrate the necessary preclinical outcomes to progress to clinical studies, or our product candidates may be shown to have
harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing
approval.
If any of these events
occur, we may be forced to discontinue our development efforts for a program or programs. Research programs to identify new product
candidates require substantial technical, financial and human resources. We may focus our efforts and resources on potential programs
or product candidates that ultimately prove to be unsuccessful.
We may not be able to obtain orphan
drug exclusivity for some of our product candidates.
Of our current product
candidates, the only one designed for treatment of an indication that would likely qualify for rare disease status is IMM-529 for
the treatment of recurrent C. difficile. Regulatory authorities in some jurisdictions, including the U.S. and the European
Union, may designate drugs or biological products for relatively small patient populations as orphan drugs. Under the Orphan Drug
Act, the FDA may designate a product as an orphan drug if it is a product intended to treat a rare disease or condition, which
is generally defined as a patient population of fewer than 200,000 individuals annually in the U.S. The FDA may also designate
a product as an orphan drug if it is intended to treat a disease or condition of more than 200,000 individuals in the U.S. and
there is no reasonable expectation that the cost of developing and making a drug or biological product available in the U.S. for
this type of disease or condition will be recovered from sales of the product candidate. Under the European Union orphan drug legislation,
a rare disease or condition means a disease or condition which affects not more than five in ten thousand persons in the European
Union at the time of the orphan drug designation application.
Generally, if a product
with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation,
the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application
for the same drug for that time period. During the marketing exclusivity period, in the European Union, the European Medicines
Agency, or the EMA, is precluded from approving a similar drug with an identical therapeutic indication. The applicable period
is seven years in the U.S. and ten years in the European Union. The European Union exclusivity period can be reduced to six years
if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity
is no longer justified. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially
defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare
disease or condition.
Even if we obtain
orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different
drugs can be approved for the same condition, and the same drug could be approved for a different condition. Even after an orphan
drug is approved, the FDA can subsequently approve the same drug, made by a competitor, for the same condition if the FDA concludes
that the competitive product is clinically superior in that it is shown to be safer, more effective or makes a major contribution
to patient care. In the European Union, the EMA can approve a competitive product if the orphan drug no longer meets the criteria
for orphan designation (including sufficient profitability), if the competitive product is safer, more effective or otherwise clinically
superior, or if the orphan drug cannot be supplied in sufficient quantities.
We have not entered into agreements
with any third-party manufacturers to support commercialization of our pharmaceutical product candidates. Additionally, no manufacturers
have experience producing our product candidates at commercial levels, and any manufacturer that we work with may not achieve the
necessary regulatory approvals or produce our product candidates at the quality, quantities, locations and timing needed to support
commercialization.
We have not yet secured
manufacturing capabilities for commercial quantities of our product candidates or established facilities in the desired locations
to support commercialization of our product candidates. We intend to rely on third-party manufacturers for commercialization, and
currently we have only entered into agreements with such manufacturers to support our clinical trials for IMM-124E. We may be unable
to negotiate agreements with third-party manufacturers to support our commercialization activities on commercially reasonable terms.
We may encounter technical
or scientific issues related to manufacturing or development that we may be unable to resolve in a timely manner or with available
funds. Currently, we do not have the capacity to manufacture our product candidates on a commercial scale. In addition, our product
candidates are novel, and no manufacturer currently has experience producing our product candidates on a large scale. If we are
unable to engage manufacturing partners to produce our product candidates on a larger scale on reasonable terms, our commercialization
efforts will be harmed.
Even if we timely
develop a manufacturing process and successfully transfer it to the third-party manufacturers of our product candidates, if such
third-party manufacturers are unable to produce the necessary quantities of our product candidates, or do so in compliance with
Current Good Manufacturing Practice (“cGMP”) or with pertinent foreign regulatory requirements, and within our planned
time frame and cost parameters, the development and sales of our product candidates, if approved, may be impaired.
Risks Related to Government Regulation
If we do not obtain the necessary governmental
approvals, we will be unable to commercialize our pharmaceutical products.
Our ongoing research
and development activities are, and the production and marketing of our pharmaceutical product candidates derived from such activities
will be, subject to regulation by numerous international regulatory authorities. Prior to marketing, any therapeutic product developed
must undergo rigorous pre-clinical testing and clinical trials and, to the extent that any of our pharmaceutical products under
development are marketed abroad, by the relevant international regulatory authorities. For example, in Australia, principally the
Therapeutics Goods Administration (“TGA”), the FDA in the U.S.; the Medicines and Healthcare products Regulatory Agency,
(“MHRA”) in the United Kingdom; the Medical Products Agency (“MPA”) in Sweden; and the EMA in Europe. These
regulatory processes can take many years and require the expenditure of substantial resources. Governmental authorities may not
grant regulatory approval due to matters arising from pre-clinical animal toxicology, safety pharmacology, drug formulation and
purity, clinical side effects or patient risk profiles, or medical contraindications. Failure or delay in obtaining regulatory
approvals would adversely affect the development and commercialization of our pharmaceutical product candidates. We may not be
able to obtain the clearances and approvals necessary for clinical testing or for manufacturing and marketing our pharmaceutical
product candidates.
We will not be able to commercialize
any current or future product candidates if we fail to adequately demonstrate their safety, efficacy and superiority over existing
therapies.
Before obtaining regulatory
approvals for the commercial sale of any of our pharmaceutical products, we must demonstrate through pre- clinical testing and
clinical studies that our product candidates are safe and effective for use in humans for each target indication. Results from
early clinical trials may not be predictive of results obtained in large-scale, later-stage clinical testing. Even though a potential
drug product shows promising results in clinical trials, regulatory authorities may not grant the necessary approvals without sufficient
safety and efficacy data.
We may not be able
to undertake further clinical trials of our current and future product candidates as therapies for fatty-liver disease, C. difficile
or other indications or to demonstrate the safety and efficacy or superiority of any of these product candidates over existing
therapies or other therapies under development, or enter into any collaborative arrangement to commercialize our current or future
product candidates on terms acceptable to us, or at all. Clinical trial results that show insufficient safety and efficacy could
adversely affect our business, financial condition and results of operations.
Even if we obtain regulatory approval
for a product candidate, our products may remain subject to regulatory scrutiny.
Even if we obtain
regulatory approval in a jurisdiction, the regulatory authority may still impose significant restrictions on the indicated uses
or marketing of our product candidates or impose ongoing requirements for potentially costly post-approval studies or post-market
surveillance. For example, the holder of an approved biologics license application (“BLA”) is obligated to monitor
and report to the FDA adverse events and any failure of a product to meet the specifications in the BLA. The holder of an approved
BLA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product
labeling or manufacturing process.
Advertising and promotional
materials must comply with FDA rules and are subject to FDA review, in addition to other potentially applicable foreign, federal
and state laws.
If we fail to comply with applicable regulatory
requirements following approval of any of our product candidates, a regulatory agency may:
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issue a warning letter asserting that we are in violation of the law;
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seek an injunction or impose civil or criminal penalties or monetary fines;
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suspend or withdraw regulatory approval;
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suspend any ongoing clinical trials;
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refuse to permit government reimbursement of our product by government-sponsored third-party payors;
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refuse to approve a pending BLA or supplements to a BLA submitted by us for other indications or
new product candidates;
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refuse to allow us to enter into or continue supply contracts, including government contracts.
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Any government investigation
of alleged violations of law could require us to expend significant time and resources in response and could generate negative
publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates
and generate revenues.
Healthcare reform measures and other
statutory or regulatory changes could adversely affect our business.
In both the United
States and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare
system in ways that could impact our business. For example, the Patient Protection and Affordable Care Act and the Health Care
and Education Affordability Reconciliation Act of 2010 (collectively, the “ACA”), enacted in March 2010, substantially
changed the way healthcare is financed by both governmental and private insurers, and significantly impacts the pharmaceutical
industry. With regard to pharmaceutical products, among other things, the ACA is expected to expand and increase industry rebates
for drugs covered under Medicaid programs and make changes to the coverage requirements under the Medicare D program.
If we fail to comply
with our reporting and payment obligations under the Medicaid program or other governmental pricing programs, we could be subject
to additional reimbursement requirements, penalties, sanctions and fines which could have a material adverse effect on our business,
financial condition, results of operations and growth prospects.
If we obtain FDA approval
for any of our product candidates and begin commercializing those products in the United States, our operations may be directly
or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation,
the federal Anti-Kickback Statute, the federal False Claims Act, and physician sunshine laws and regulations.
The pharmaceutical
and biotechnology industries are subject to extensive regulation, and from time to time legislative bodies and governmental agencies
consider changes to such regulations that could have significant impact on industry participants. For example, in light of certain
highly-publicized safety issues regarding certain drugs that had received marketing approval, the U.S. Congress has considered
various proposals regarding drug safety, including some which would require additional safety studies and monitoring and could
make drug development costlier. Additional legislation or regulation, if any, relating to the implementation of cost containment
measures or other aspects of drug development may prevent us from being able to generate revenue, attain profitability, or commercialize
our products. Such reforms could have an adverse effect on anticipated revenues from product candidates that we may successfully
develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product
candidates. In addition, it is possible that there will be further legislation or regulation that could harm our business, financial
condition and results of operations.
Our product candidates are based on
our hyper-immune colostrum technology. Currently, no prescription product candidates utilizing our technology have been approved
for commercial sale and our approach to the development of our technology may not result in safe, effective or marketable products.
We have concentrated
our product research and development efforts on our hyper-immune colostrum technology, and our future success depends on successful
clinical development of this technology. We plan to develop a pipeline of product candidates using our technology and deliver
therapeutics for a number of infectious and life-threatening conditions, including C. difficile Infections (“CDI”),
Shigellosis (bacillary dysentery) and Traveler’s Diarrhea.
The scientific research
that forms the basis of our efforts to develop product candidates is based on the pre-clinical and clinical data in conditions
such as CDI, Shigellosis (bacillary dysentery) and Traveler’s Diarrhea, and the identification, optimization and delivery
of hyper-immune colostrum- based product candidates is relatively new. The scientific evidence to support the feasibility of successfully
developing therapeutic treatments based on our technology is preliminary and limited. There can be no assurance that any development
and technical problems we experience in the future will not cause significant delays or unanticipated costs, or that such development
problems can be solved. We may be unable to reach an agreement on favorable terms, or at all, with providers of vectors needed
to optimize delivery of our product candidates to target disease cells and we may also experience unanticipated problems or delays
in expanding our manufacturing capacity or transferring our manufacturing process to commercial partners, any of which may prevent
us from completing our clinical trials or commercializing our products on a timely or profitable basis, if at all.
Only a few product candidates
based on our technology have been tested in either animals or humans. We may discover that the applications of IMM-124E and IMM-529
do not possess properties required for a therapeutic benefit, such as the ability to sufficiently suppress the immune system for
the period of time required to be approved as a NASH or CDI therapeutic. In addition, application of hyper-immune- based products
in humans may result in safety problems. We currently have only limited long-term data, and no conclusive evidence, to suggest
that we can effectively produce efficacious therapeutic treatments using our hyper-immune colostrum technology.
We are early in our product development
efforts and have only two product candidates in early-stage (Phase I) and mid-stage (Phase II) clinical trials. All of our other
current product candidates are still in preclinical development. We have no late-stage clinical trials (post-proof of concept)
and may not be able to obtain regulatory approvals for the commercialization of some or all of our product candidates.
The research, testing,
manufacturing, labeling, approval, selling, marketing and distribution of biologics is subject to extensive regulation by the FDA
and other regulatory authorities, and these regulations differ from country to country. We do not have any prescription products
on the market and are early in our development efforts. We have two product candidates in clinical trials and all of our other
product candidates are in preclinical development. All of our current and future product candidates are subject to the risks of
failure typical for development of biologics. The development and approval process is expensive and can take many years to complete,
and its outcome is inherently uncertain. In addition, the outcome of preclinical testing and early clinical trials may not be predictive
of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.
We have not submitted
an application, or received marketing approval, for any of our product candidates and will not submit any applications for marketing
approval for several years. We have limited experience in conducting and managing clinical trials necessary to obtain regulatory
approvals for prescription product candidates. To receive approval, we must, among other things, demonstrate with evidence from
clinical trials that the product candidate is both safe and effective for each indication for which approval is sought, and failure
can occur in any stage of development. Satisfaction of the approval requirements typically takes several years and the time needed
to satisfy them may vary substantially, based on the type, complexity and novelty of the pharmaceutical product. We cannot predict
if or when we might receive regulatory approvals for any of our product candidates currently under development.
The FDA and foreign
regulatory authorities also have substantial discretion in the pharmaceutical and biological product approval process. The numbers,
types and sizes of preclinical studies and clinical trials that will be required for regulatory approval varies depending on the
product candidate, the disease or condition that the product candidate is designed to address and the regulations applicable to
any particular product candidate. Approval policies, regulations or the type and amount of clinical data necessary to gain approval
may change during the course of a product candidate’s clinical development and may vary among jurisdictions, and there may
be varying interpretations of data obtained from preclinical studies or clinical trials, any of which may cause delays or limitations
in the approval or the decision not to approve an application. Regulatory agencies can delay, limit or deny approval of a product
candidate for many reasons, including:
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation
of our clinical trials;
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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory
authorities that a product candidate is safe and effective for its proposed indication;
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the results of clinical trials may not meet the level of statistical or clinical significance required
by the FDA or comparable foreign regulatory authorities for approval;
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the patients recruited for a particular clinical program may not be sufficiently broad or representative
to assure safety in the full population for which we seek approval;
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the results of clinical trials may not confirm the positive results from earlier preclinical studies
or clinical trials;
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we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh
its safety risks;
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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data
from preclinical studies or clinical trials;
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the data collected from clinical trials of our product candidates may not be sufficient to the
satisfaction of FDA or comparable foreign regulatory authorities to support the submission of a biologics license application,
or BLA, or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the U.S. or elsewhere;
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the FDA or comparable foreign regulatory authorities may only agree to approve a product candidate
under conditions that are so restrictive that the product is not commercially viable;
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regulatory agencies might not approve or might require changes to our manufacturing processes or
facilities; or
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regulatory agencies may change their approval policies or adopt new regulations in a manner rendering
our clinical data insufficient for approval.
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Any delay in obtaining
or failure to obtain required approvals could materially and adversely affect our ability to generate revenue from the particular
product candidate, which likely would result in significant harm to our financial position and adversely impact the price of the
ADSs. Furthermore, any regulatory approval to market a product may be subject to limitations on the indicated uses for which we
may market the product. These limitations may limit the size of the market for the product.
We are not permitted
to market our product candidates in the U.S. or in other countries until we receive approval of a BLA from the FDA or marketing
approval from applicable regulatory authorities outside the U.S. Obtaining approval of a BLA can be a lengthy, expensive and uncertain
process. If we fail to obtain FDA approval to market our product candidates, we will be unable to sell our product candidates in
the U.S., which will significantly impair our ability to generate any revenues. In addition, failure to comply with FDA and non-U.S.
regulatory requirements may, either before or after product approval, if any, subject us to administrative or judicially imposed
sanctions, including:
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restrictions on our ability to conduct clinical trials, including full or partial clinical holds
on ongoing or planned trials;
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restrictions on the products, manufacturers or manufacturing process;
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civil and criminal penalties;
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suspension or withdrawal of regulatory approvals;
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product seizures, detentions or import bans;
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voluntary or mandatory product recalls and publicity requirements;
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total or partial suspension of production;
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imposition of restrictions on operations, including costly new manufacturing requirements; and
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refusal to approve pending BLAs or supplements to approved BLAs.
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Even if we do receive
regulatory approval to market a product candidate, any such approval may be subject to limitations on the indicated uses for which
we may market the product. It is possible that none of our existing product candidates or any product candidates we may seek to
develop in the future will ever obtain the appropriate regulatory approvals necessary for us or our collaborators to commence product
sales.
Any delay in obtaining,
or an inability to obtain, applicable regulatory approvals would prevent us from commercializing our product candidates, generating
revenues and achieving and sustaining profitability.
If our ability to use cumulative carry
forward net operating losses is or becomes subject to certain limitations, our results of operations and financial condition may
be adversely affected.
We are an Australian
company subject to taxation in Australia and other jurisdictions. As of June 30, 2019, our cumulative operating losses have a total
potential tax benefit of A$10,230,814 at local tax rates (excluding other temporary differences). These losses may be available
for use once we are in a tax profitable position. These losses were incurred in different jurisdictions and can only be offset
against profits earned in the relevant jurisdictions. Tax losses are able to be carried forward at their nominal amount indefinitely
in Australia and for losses generated prior to January 1, 2018 for up to 20 years in the U.S. as long as certain conditions are
met. In order to use these tax losses, it is necessary to satisfy certain tests and, as a result, we cannot assure you that the
tax losses will be available to offset profits if and when we earn them. Utilization of our net operating loss and research and
development credit carryforwards in the U.S. may be subject to substantial annual limitation due to ownership change limitations
that could occur in the future provided by Section 382 of the Internal Revenue Code of 1986, as amended. Our carry forward net
operating losses in the U.S. first start to expire in 2035.
We could be adversely affected by
violations of the U.S. Foreign Corrupt Practices Act.
Our business operations
may be subject to anti-corruption laws and regulations, including restrictions imposed by the U.S. Foreign Corrupt Practices Act
the FCPA. The FCPA and similar anti-corruption laws in other jurisdictions generally prohibit companies and their intermediaries
from making improper payments to government officials for the purpose of obtaining or retaining business. We cannot provide assurance
that our internal controls and procedures will always protect us from criminal acts committed by our employees or third parties
with whom we work. If we are found to be liable for violations of the FCPA or similar anti-corruption laws in international jurisdictions,
either due to our own acts or out of inadvertence, or due to the acts or inadvertence of others, we could suffer from criminal
or civil penalties which could have a material and adverse effect on our results of operations, financial condition and cash flows.
Risks Related to Our Intellectual
Property
Our success depends upon our ability
to protect our intellectual property and our proprietary technology, to operate without infringing the proprietary rights of third
parties and to obtain marketing exclusivity for our products and technologies.
Any future success will depend in large
part on whether we can:
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obtain and maintain patents to protect our own products and technologies;
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obtain orphan designation for our products and technologies;
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obtain licenses to the patented technologies of third parties;
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operate without infringing on the proprietary rights of third parties; and
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protect our trade secrets, know-how and other confidential information.
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Patent matters in
biotechnology are highly uncertain and involve complex legal and factual questions. Accordingly, the availability and breadth of
claims allowed in biotechnology and pharmaceutical patents cannot be predicted. Any of the pending or future patent applications
filed by us or on our behalf may not be approved, we may not develop additional proprietary products or processes that are patentable,
or we may not be able to license any other patentable products or processes.
Our products may be
eligible for orphan designation for particular therapeutic indications that are of relatively low prevalence and for which there
is no effective treatment. Orphan drug designation affords market exclusivity post marketing authorization for a product for a
specified therapeutic utility. The period of orphan protection is dependent on jurisdiction, for example, seven years in the U.S.
and ten years in Europe. The opportunity to gain orphan drug designation depends on a variety of requirements specific to each
marketing jurisdiction and can include; a showing of improved benefit relative to marketed products, that the mechanism of action
of the product would provide plausible benefit and the nature of the unmet medical need within a therapeutic indication. It is
uncertain if our products will be able to obtain orphan drug designation for the appropriate indications and in the jurisdictions
sought.
Our commercial success
will also depend, in part, on our ability to avoid infringement of patents issued to others. If a court determines that we were
infringing any third-party patents, we could be required to pay damages, alter our products or processes, obtain licenses or cease
certain activities. Licenses required under patents held by third parties may not be made available on terms acceptable to us,
or at all. To the extent that we are unable to obtain such licenses, we could be foreclosed from the development, export, manufacture
or commercialization of the product requiring such license or encounter delays in product introductions while we attempt to design
around such patents, and any of these circumstances could adversely affect our business, financial condition and results of operations.
We may have to resort
to litigation to enforce any patents issued or licensed to us or to determine the scope and validity of third party proprietary
rights. We may have to defend the validity of our patents in order to protect or enforce our rights against a third party. Third
parties may, in the future, assert against us infringement claims or claims that we have infringed a patent, copyright, trademark
or other proprietary right belonging to them. Any infringement claim, even if not meritorious, could result in the expenditure
of significant financial and managerial resources and could negatively affect our profitability. While defending our patents, the
scope of the claim may be reduced in breadth and inventorship of the claimed subject matter, and proprietary interests in the claimed
subject matter may be altered or reduced. Some of our competitors may be able to sustain the costs of such litigation or proceedings
more effectively than we can because of their substantially greater financial resources. Any such litigation or proceedings, regardless
of outcome, could be expensive and time consuming, and adverse determinations in any such litigation or proceedings could prevent
us from developing, manufacturing or commercializing our products and could adversely affect our business, financial condition
and results of operations.
The patents for our
product candidates have varying expiration dates and, if these patents expire, we may be subject to increased competition and we
may not be able to recover our development costs or market any of our approved products profitably. In some of the larger potential
market territories, such as the U.S. and Europe, patent term extension or restoration may be available to compensate for time taken
during aspects of the product’s development and regulatory review or by procedural delays before the relevant patent office.
However, such an extension may not be granted, or if granted, the applicable time period or the scope of patent protection afforded
during any extension period may not be sufficient. In addition, even though some regulatory authorities may provide some other
exclusivity for a product under their own laws and regulations, we may not be able to qualify the product or obtain the exclusive
time period. If we are unable to obtain patent term extension/restoration or some other exclusivity, we could be subject to increased
competition and our opportunity to establish or maintain product revenue could be substantially reduced or eliminated. Furthermore,
we may not have sufficient time to recover our development costs prior to the expiration of our U.S. and non-U.S. patents.
We may face difficulties in certain
jurisdictions in protecting our intellectual property rights, which may diminish the value of our intellectual property rights
in those jurisdictions.
The laws of some jurisdictions
do not protect intellectual property rights to the same extent as the laws in the U.S. and the European Union, and many companies
have encountered significant difficulties in protecting and defending such rights in such jurisdictions. If we or our collaboration
partners encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property
rights important for our business in such jurisdictions, the value of these rights may be diminished and we may face additional
competition from others in those jurisdictions.
Many countries 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 such patent. If we or any of our licensors is forced to
grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired
and our business, financial condition and results of operations may be adversely affected.
Intellectual property rights do not
address all potential threats to our competitive advantage.
The degree of future
protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and
may not adequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative:
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Others may be able to make products that are similar to ours but that are not covered by the claims
of the patents that we own.;
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Others may independently develop similar or alternative technologies or otherwise circumvent any
of our technologies without infringing our intellectual property rights;
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We or any of our collaboration partners might not have been the first to conceive and reduce to
practice the inventions covered by the patents or patent applications that we own, license or will own or license;
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We or any of our collaboration partners might not have been the first to file patent applications
covering certain of the patents or patent applications that we or they own or have obtained a license, or will own or will have
obtained a license;
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It is possible that our pending patent applications will not lead to issued patents;
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Issued patents that we own may not provide us with any competitive advantage, or may be held invalid
or unenforceable, as a result of legal challenges;
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Our competitors might conduct research and development activities in countries where we do not
have patent rights, or in countries where research and development safe harbor laws exist, and then use the information learned
from such activities to develop competitive products for sale in our major commercial markets;
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The patents of third parties or pending or future applications of third parties, if issued, may
have an adverse effect on our business; and/or
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Compulsory licensing provisions of certain governments to patented technologies that are deemed
necessary for the government to access.
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Changes in patent laws or patent jurisprudence
could diminish the value of patents in general, thereby impairing our ability to protect our products or product candidates.
As is the case with
other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and
enforcing patents involves both technological complexity and legal complexity and is costly, time-consuming and inherently uncertain.
In addition, the America Invents Act was recently enacted in the U.S., resulting in significant changes to the U.S. patent system.
The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available
in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty
with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to
the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the U.S. Patent and Trademark
Office, or USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to
obtain new patents or to enforce our existing patents and patents that we might obtain in the future. Similarly, the complexity
and uncertainty of European patent laws has also increased in recent years. In addition, the European patent system is relatively
stringent with regard to the type of amendments that are allowed during prosecution. These changes could limit our ability to obtain
new patents in the future that may be important for our business.
Confidentiality agreements with employees
and others may not adequately prevent disclosure of trade secrets and protect other proprietary information.
We consider proprietary
trade secrets and/or confidential know-how and unpatented know-how to be important to our business. We may rely on trade secrets
and/or confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value.
However, trade secrets and/or confidential know-how can be difficult to maintain as confidential.
To protect this type
of information against disclosure or appropriation by competitors, our policy is to require our employees, consultants, contractors
and advisors to enter into confidentiality agreements with us. However, current or former employees, consultants, contractors and
advisers may unintentionally or willfully disclose our confidential information to competitors, and confidentiality agreements
may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Enforcing a claim that
a third-party obtained illegally and is using trade secrets and/or confidential know-how is expensive, time consuming and unpredictable.
The enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction.
Failure to obtain or maintain trade secrets
and/or confidential know-how trade protection could adversely affect our competitive position. Moreover, our competitors may independently
develop substantially equivalent proprietary information and may even apply for patent protection in respect of the same. If successful
in obtaining such patent protection, our competitors could limit our use of our trade secrets and/or confidential know-how.
Risks Related to Our Securities
The market price and trading volume
of our ADS may be volatile and may be affected by economic conditions beyond our control.
The market price of
our ADS may be highly volatile and subject to wide fluctuations. In addition, the trading volume of the ADS may fluctuate and cause
significant price variations to occur. If the market price of the ADS declines significantly, you may be unable to resell your
ADS at or above the purchase price, if at all. We cannot assure you that the market price of the ADS will not fluctuate or significantly
decline in the future.
Some specific factors
that could negatively affect the price of the ADS or result in fluctuations in their price and trading volume include:
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actual or expected fluctuations in our operating results;
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changes in market valuations of similar companies;
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changes in our key personnel;
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changes in financial estimates or recommendations by securities analysts;
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trading prices of our ordinary shares on the Australian Securities Exchange (“ASX”);
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changes in trading volume of ADS on The NASDAQ Capital Market, or NASDAQ, and of our ordinary shares
on the ASX;
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sales of the ADS or ordinary shares by us, our executive officers or our shareholders in the future;
and
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conditions in the financial markets or changes in general economic conditions.
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The dual listing of our ordinary shares
and the ADSs may adversely affect the liquidity and value of the ADS.
Our ordinary shares
are listed on the ASX. We cannot predict the effect of this dual listing on the value of our ordinary shares and ADS. However,
the dual listing of our ordinary shares and ADS may dilute the liquidity of these securities in one or both markets and may impair
the development of an active trading market for the ADS in the U.S. The trading price of the ADSs could also be adversely affected
by trading in our ordinary shares on the ASX.
As a foreign private issuer, we are
permitted, and we expect to follow certain home country corporate governance practices in lieu of certain NASDAQ requirements applicable
to domestic issuers. This may afford less protection to holders of our ADSs.
As a foreign private
issuer whose shares are listed on NASDAQ, we are permitted to follow certain home country corporate governance practices instead
of certain requirements of the NASDAQ Stock Market Rules. Among other things, as a foreign private issuer we have elected to follow
home country practice with regard to, the composition of the board of directors and the audit committee, the financial expert,
director nomination procedure, compensation of officers and quorum at shareholders’ meetings. In addition, we may follow
our home country law, instead of the NASDAQ Stock Market Rules, which require that we obtain shareholder approval for certain dilutive
events, such as for the establishment or amendment of certain equity based compensation plans, an issuance that will result in
a change of control of the company, certain transactions other than a public offering involving issuances of a 20% or more interest
in the company and certain acquisitions of the stock or assets of another company. Accordingly, our shareholders may not be afforded
the same protection as provided under NASDAQ’s corporate governance rules. See Item 16G - Corporate Governance.
As a foreign private issuer, we are
permitted to file less information with the SEC than a company incorporated in the U.S. Accordingly, there may be less publicly
available information concerning us than there is for companies incorporated in the U.S.
As a foreign private
issuer, we are exempt from certain rules under the Exchange Act that impose disclosure requirements as well as procedural requirements
for proxy solicitations under Section 14 of the Exchange Act. In addition, our officers, directors and principal shareholders are
exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act. Moreover,
we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as a company that
files as a U.S. company whose securities are registered under the Exchange Act, nor are we required to comply with the SEC’s
Regulation FD, which restricts the selective disclosure of material non-public information. Accordingly, there may be less information
publicly available concerning us than there is for a company that files as a domestic issuer.
We are an emerging growth company
as defined in the JOBS Act and the reduced disclosure requirements applicable to emerging growth companies may make the ADS less
attractive to investors and, as a result, adversely affect the price of the ADS and result in a less active trading market for
the ADS.
We are an emerging
growth company as defined in the JOBS Act, and we may take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies that are not emerging growth companies. For example, we have elected to rely on an
exemption from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act relating to internal control over
financial reporting, and we will not provide such an attestation from our auditors for so long as we qualify as an emerging growth
company.
We may avail ourselves
of these disclosure exemptions until we are no longer an emerging growth company. We cannot predict whether investors will find
the ADS less attractive because of our reliance on some or all of these exemptions. If investors find the ADS less attractive,
it may cause the trading price of the ADS to decline and there may be a less active trading market for the ADS.
We will cease to be
an emerging growth company upon the earliest of:
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the end of the fiscal year in which the fifth anniversary of completion of our initial public offering
(“IPO”) occurs;
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the end of the first fiscal year in which the market value of our ordinary shares held by non-affiliates
exceeds US$700 million as of the end of the second quarter of such fiscal year;
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the end of the first fiscal year in which we have total annual gross revenues of at least US$1.07
billion; and
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the date on which we have issued more than US$1 billion in non-convertible debt securities in any
rolling three-year period.
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If we fail to comply with the rules under
the Sarbanes-Oxley Act of 2002 related to accounting controls and procedures in the future, or, if we discover additional material
weaknesses and other deficiencies in our internal control and accounting procedures, the price of our ordinary shares and ADSs
could decline significantly and raising capital could be more difficult. Previously, our management determined that our disclosure
controls and procedures and internal controls were ineffective as of June 30, 2018.
If we fail to comply
with the rules under the Sarbanes-Oxley Act of 2002 related to disclosure controls and procedures in the future, or, if we
discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline
significantly and raising capital could be more difficult. Section 404 of the Sarbanes-Oxley Act requires annual management
assessments of the effectiveness of our internal control over financial reporting. As of June 30, 2018, our management determined
that we had material weaknesses in our control environment and in the period end financial close and reporting process. We have
since remediated such material weaknesses and our internal controls and accounting procedures are effective. If additional material
weaknesses or significant deficiencies are discovered or if we otherwise fail to achieve and maintain the adequacy of our internal
control, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal controls over financial
reporting in accordance with Section 404 of the Sarbanes-Oxley Act. Moreover, effective internal controls are necessary for
us to produce reliable financial reports and are important to helping prevent financial fraud. If we cannot provide reliable financial
reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported
financial information, and the trading price of our ordinary shares and ADSs could drop significantly.
ADS holders may be subject to additional
risks related to holding ADS rather than ordinary shares.
ADS holders do not
hold ordinary shares directly and, as such, are subject to, among others, the following additional risks:
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As an ADS holder, we will not treat you as one of our shareholders and you will not be able to
exercise shareholder rights, except through the ADR depositary as permitted by the amended and restated deposit agreement among
the Company, The Bank of New York Mellon, as depositary, and owners and holders of our ADSs (the “Deposit Agreement”);
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distributions on the ordinary shares represented by your ADS will be paid to the ADR depositary,
and before the ADR depositary makes a distribution to you on behalf of your ADSs, any withholding taxes that must be paid will
be deducted. Additionally, if the exchange rate fluctuates during a time when the ADR depositary cannot convert the foreign currency,
you may lose some or all of the value of the distribution; and
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We and the ADR depositary may amend or terminate the Deposit Agreement without the ADS holders’
consent in a manner that could prejudice ADS holders.
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You must act through the ADR depositary
to exercise your voting rights and, as a result, you may be unable to exercise your voting rights on a timely basis.
As a holder of ADS
(and not the ordinary shares underlying your ADSs), we will not treat you as one of our shareholders, and you will not be able
to exercise shareholder rights. The ADR depositary will be the holder of the ordinary shares underlying your ADS, and ADS holders
will be able to exercise voting rights with respect to the ordinary shares represented by the ADS only in accordance with the Deposit
Agreement relating to the ADS. There are practical limitations on the ability of ADS holders to exercise their voting rights due
to the additional procedural steps involved in communicating with these holders. For example, holders of our ordinary shares will
receive notice of shareholders’ meetings by mail and will be able to exercise their voting rights by either attending the
shareholders meeting in person or voting by proxy. ADS holders, by comparison, will not receive notice directly from us. Instead,
in accordance with the Deposit Agreement, we will provide notice to the ADR depositary of any such shareholders meeting and details
concerning the matters to be voted upon at least 30 days in advance of the meeting date. If we so instruct, the ADR depositary
will mail to holders of ADS the notice of the meeting and a statement as to the manner in which voting instructions may be given
by holders as soon as practicable after receiving notice from us of any such meeting. To exercise their voting rights, ADS holders
must then instruct the ADR depositary as to voting the ordinary shares represented by their ADSs. Due to these procedural steps
involving the ADR depositary, the process for exercising voting rights may take longer for ADS holders than for holders of ordinary
shares. The ordinary shares represented by ADS for which the ADR depositary fails to receive timely voting instructions will not
be voted.
If we are classified as a “passive
foreign investment company,” then our U.S. shareholders could suffer adverse tax consequences as a result.
Generally, if, for
any taxable year, at least 75% of our gross income is passive income (including our pro rata share of the gross income of our
25% or more owned corporate subsidiaries) or at least 50% of the average quarterly value of our total gross assets (including
our pro rata share of the gross assets of our 25% or more owned corporate subsidiaries) is attributable to assets that produce
passive income or are held for the production of passive income, including cash, we would be characterized as a passive foreign
investment company, or PFIC, for U.S. federal income tax purposes. For purposes of these tests, passive income includes dividends,
interest, and gains from the sale or exchange of investment property and rents and royalties other than rents and royalties which
are received from unrelated parties in connection with the active conduct of a trade or business. If we are characterized as a
PFIC, a U.S. holder of our ordinary shares or ADSs may suffer adverse tax consequences, including having gains recognized on the
sale of our ordinary shares or ADSs treated as ordinary income, rather than capital gain, the loss of the preferential rate applicable
to dividends received on our ordinary shares or ADSs by individuals who are U.S. holders, and having interest charges added to
their tax on distributions from us and on gains from the sale of our ordinary shares or ADS. See “Taxation—United
States Federal Income Tax Considerations—Passive Foreign Investment Company.”
Our status as a PFIC
may also depend, in part, on how quickly we utilize any cash proceeds from any offering. Since PFIC status depends on the composition
of our income and the composition and value of our assets, which may be determined in large part by reference to the market value
of our ordinary shares or ADS, which may be volatile, there can be no assurance that we will not be a PFIC for any taxable year.
While we expect that we were not a PFIC for our taxable year ended June 30, 2019, no assurance of our PFIC status can be provided
for such taxable year or future taxable years. Prospective U.S. investors should discuss the issue of our possible status as a
PFIC with their tax advisors.
Currency fluctuations may adversely
affect the price of our ordinary shares and ADS.
Our ordinary shares
are quoted in Australian dollars on the ASX and the ADS are quoted in U.S. dollars on NASDAQ. Movements in the Australian dollar/U.S.
dollar exchange rate may adversely affect the U.S. dollar price of the ADS. In the past year the Australian dollar has generally
weakened against the U.S. dollar. However, this trend may not continue and may be reversed. If the Australian dollar weakens against
the U.S. dollar, the U.S. dollar price of the ADS could decline, even if the price of our ordinary shares in Australian dollars
increases or remains unchanged.
We have never declared or paid dividends
on our ordinary shares and we do not anticipate paying dividends in the foreseeable future.
We have never declared
or paid cash dividends on our ordinary shares. For the foreseeable future, we currently intend to retain all available funds and
any future earnings to support our operations and to finance the growth and development of our business. Any future determination
to declare cash dividends will be made at the discretion of our board of directors, subject to compliance with applicable laws
and covenants under current or future credit facilities, which may restrict or limit our ability to pay dividends, and will depend
on our financial condition, operating results, capital requirements, general business conditions and other factors that our board
of directors may deem relevant. We do not anticipate paying any cash dividends on our ordinary shares in the foreseeable future.
As a result, a return on your investment will only occur if our ADS price appreciates.
You may not receive distributions
on our ordinary shares represented by the ADS or any value for such distribution if it is illegal or impractical to make them available
to holders of ADS.
While we do not anticipate
paying any dividends on our ordinary shares in the foreseeable future, if such a dividend is declared, the depositary for the ADS
has agreed to pay to you the cash dividends or other distributions it or the custodian receives on our ordinary shares or other
deposited securities after deducting its fees and expenses. You will receive these distributions in proportion to the number of
our ordinary shares your ADS represent. However, in accordance with the limitations set forth in the Deposit Agreement, it may
be unlawful or impractical to make a distribution available to holders of ADS. We have no obligation to take any other action to
permit the distribution of the ADS, ordinary shares, rights or anything else to holders of the ADS. This means that you may not
receive the distributions we make on our ordinary shares or any value from them if it is unlawful or impractical to make them available
to you. These restrictions may have a material adverse effect on the value of your ADS.
Australian takeover laws may discourage
takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares or ADS.
We are incorporated
in Australia and are subject to the takeover laws of Australia. Among other things, we are subject to the Australian Corporations
Act 2001, or the Corporations Act. Subject to a range of exceptions, the Corporations Act prohibits the acquisition of a direct
or indirect interest in our issued voting shares if the acquisition of that interest will lead to a person’s voting power
in us increasing to more than 20%, or increasing from a starting point that is above 20% and below 90%. Australian takeover laws
may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares.
This may have the ancillary effect of entrenching our board of directors and may deprive or limit our shareholders’ or ADS
holders’ opportunity to sell their ordinary shares or ADSs and may further restrict the ability of our shareholders and ADS
holders to obtain a premium from such transactions. See Item 10. – Additional Information “Change of Control”.
Our Constitution and Australian laws
and regulations applicable to us may adversely affect our ability to take actions that could be beneficial to our shareholders.
As an Australian company,
we are subject to different corporate requirements than a corporation organized under the laws of the states of the U.S. Our Constitution,
as well as the Australian Corporations Act, set forth various rights and obligations that are unique to us as an Australian company.
These requirements may operate differently than those of many U.S. companies. See Item 10 - Additional Information.
You will have limited ability to bring
an action against us or against our directors and officers, or to enforce a judgment against us or them, because we are incorporated
in Australia and certain of our directors and officers reside outside the U.S.
We are incorporated
in Australia, certain of our directors and officers reside outside the U.S. and substantially all of the assets owned by such persons
are located outside of the U.S.. As a result, it may be impracticable or at least more expensive for you to bring an action against
us or against these individuals in Australia in the event that you believe that your rights have been infringed under the applicable
securities laws or otherwise.
You may be subject to limitations
on transfer of the ADSs.
The ADSs are only
transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time
when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer
or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary
deem it advisable to do so because of any requirement of law or of any government or governmental body, or under any provision
of the Deposit Agreement, or for any other reason.
Australian companies may not be able
to initiate shareholder derivative actions, thereby depriving shareholders of the ability to protect their interests.
Australian companies
may not have standing to initiate a shareholder derivative action in a federal court of the U.S. The circumstances in which any
such action may be brought, and the procedures and defenses that may be available in respect to any such action, may result in
the rights of shareholders of an Australian company being more limited than those of shareholders of a company organized in the
U.S. Accordingly, shareholders may have fewer alternatives available to them if they believe that corporate wrongdoing has occurred.
Australian courts are also unlikely to recognize or enforce against us judgments of courts in the U.S. based on certain liability
provisions of U.S. securities law and to impose liabilities against us, in original actions brought in Australia, based on certain
liability provisions of U.S. securities laws that are penal in nature. Although the courts of Australia may recognize and enforce
the non-penal judgment of a foreign court of competent jurisdiction without retrial on the merits upon being satisfied about all
the relevant circumstances upon which such judgment was obtained, there is no statutory recognition in Australia of judgments obtained
in the U.S..
Anti-takeover provisions in our Constitution
and our right to issue preference shares could make a third-party acquisition of us difficult.
Some provisions of
our Constitution may discourage, delay or prevent a change in control of our company or management that shareholders may consider
favorable, including provisions that only require one-third of our board of directors to be elected annually and authorize our
board of directors to issue an unlimited number of shares of capital stock and preference shares in one or more series and to designate
the price, rights, preferences, privileges and restrictions of such preference shares by amending the Constitution.
ITEM
4. INFORMATION ON THE COMPANY
A.
History and Development of the Company
We were incorporated
under the laws of the Commonwealth of Australia in 1994 and have been listed on the ASX since April 30, 1999. Our ADSs and Warrants
have traded on The NASDAQ Capital Market since June 13, 2017. Our principal executive office is located at Level 3, 62 Lygon Street,
Carlton South, Victoria, Australia 3053 and our telephone number is +61 (0)3 9824 5254. Our agent for service in the U.S. is Puglisi & Associates, 850 Library Avenue, Suite 204, Newark, DE 19711.
B.
Business Overview
We are a clinical-stage
biopharmaceutical company with a proprietary technology platform focused on the development and commercialization of a novel class
of polyclonal antibodies that we believe can address significant unmet medical needs. Our oral polyclonal antibodies offer targeted
delivery within the gastrointestinal track but do not cross into the bloodstream, potentially leading to much improved safety and
tolerability, without sacrificing efficacy. We believe that our two lead product candidates, IMM-124E and IMM-529, have the potential
to transform the existing treatment paradigms for Travelers’ Diarrhea and for C. difficile infections, respectively.
We
currently market an OTC product, Travelan, in Australia, Canada, and the U.S. Travelan was developed utilizing our novel technology
platform and targets 13 strains of pathogenic E. coli. Travelan has been shown to be up to 90% effective in the prevention
of diarrhea in several E.coli challenge placebo controlled clinical studies. In Australia, Travelan® is a listed medicine
on the Australian Register of Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of travelers’ diarrhea,
reduce the risk of minor gastro-intestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health
product (NPN 80046016) and is indicated to reduce the risk of travelers’ diarrhea. In the U.S., Travelan® is sold as
a dietary supplement for digestive tract protection in accordance with section 403 (r)(6) of the Federal Drug Administration (FDA).
Travelan sales for fiscal year 2019 and 2018 were gross A$2.5 million (net: AUD$2.3 million) and AUD$2 million (net: AUD$1.8 million),
respectively.
OUR STRATEGY
Our goal is to become
one of the leading biopharmaceutical companies developing and commercializing therapeutics to address increased unmet medical
needs in the anti-infective area. The critical components of our strategy include:
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Aggressively advancing our two lead oral polyclonal antibody drug candidates
presently in clinical development: 1) IMM-124E as a drug to specifically prevent travelers’ diarrhea, and 2) IMM-529 to treat
recurrent C. difficile infections (CDI);
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Leveraging our technology platform and our collaborations to expand our
differentiated polyclonal-based product pipeline across multiple indications including various novel and potentially game-changing
anti-infective programs with the U.S. Department of Defense (DoD);
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Continuing to invest in and growing Travelan sales worldwide, including in the U.S., Australia, Canada, and in new markets;
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Continuing to invest in mechanism of action studies that expand our understanding
of our novel mechanism of action across our targeted diseases and conditions, and potentially identify new opportunities for investment;
and
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Protect and leverage our intellectual property portfolio and patents.
We believe that our intellectual property protection strategy, grounded in securing composition of matter patents on the
biologics we develop, as well as broader patents to protect our technology platform, has best positioned us to gain broad and
strong protection for our assets. We have 20 granted patents, 1 accepted patent awaiting grant and 9 pending patent
applications worldwide. We have been issued patents in the U.S., Australia, Canada, India, Japan and New Zealand.
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OUR PLATFORM
Our platform technology
is based on oral polyclonal immunoglobulins. Prior to calving, cows are immunized with proprietary vaccines to ensure maximum immunogenicity
and after calving, the first milk, called bovine colostrum is harvested and processed to produce bovine colostrum powder. This
proprietary process of vaccinating cows with specific vaccines generated against antigens for therapeutic targets ensures that
the colostrum contains a high concentration of polyclonal antibodies and high concentrations of immunoglobulin G1 against the specified
antigens. The technology is generally believed to be safe, low cost and can be applied to a variety of diseases.
The underlying nature
of our platform technology enables the development of medicines across a large range of diseases, including infectious diseases
and immune mediated disorders. The platform can be used to block viruses or bacteria at mucosal surfaces (such as the GI tract)
and neutralize the toxins they produce. Additionally, the dairy origins of our antibodies enable us to commercialize our platform
through most regulatory pathways, including prescription (Rx), medical foods, over-the-counter medicines, and dietary supplements.
The active pharmaceutical
ingredient (API) for a particular application is prepared using the first milking colostrum of dairy cows that have been immunized
with patented vaccines for the specific therapeutic use to produce very high levels of specific antibodies against selected surface
antigens. Pregnant dairy cows at commercial dairy farms are immunized through a proprietary process. Such inoculation of dairy
cows with specific vaccines activates a generalized immune response in the host animal to produce antibodies which recognize and
bind to bacterial cell-surface epitopes that the vaccines were designed against. These polyclonal antibodies in the harvested
bovine colostrum are present in high concentration within the raw material which is further processed to produce the final drug
product which contains at least 35% immunoglobulins (Ig), composed mainly of IgG (mostly IgG1).
Risk management covering
the source of colostrum must focus on assurance of absence of Bovine Spongiform Encephalopathy (“BSE”), commonly known
as Mad Cow Disease attributable to the liquid raw product. Australia and New Zealand are classified as Category 1 countries with
negligible BSE risk.
OUR PIPELINE
We presently have
two drug candidates in clinical development: 1) IMM-124E as a drug to prevent travelers’ diarrhea, and 2) IMM-529 to treat
recurrent C. difficile infections.
IMM-124E to Prevent Travelers’ Diarrhea
IMM-124E is manufactured
from colostrum harvested from dairy cows that have been immunized against the 13 most common pathogenic strains of enterotoxigenic
E.coli (ETEC). IMM-124E is designed to block and reduce bacterial growth without negatively impacting essential microbiota,
and is a first-in-class, oral polyclonal antibody therapeutic which targets gram negative ETEC and other cross-reactive pathogenic
bacteria in the gut, leading to the blockage of their pathologic activities.
Earlier Clinical Studies on IMM-124E
IMM-124E was evaluated
as a potential drug to treat non-alcoholic steatohepatitis (NASH) under FDA IND #014933. The primary endpoint was the mean change
from baseline in the hepatic fat fraction (HFF, %), as measured by MRI at week 24 for two doses of IMM-124E compared with placebo.
Both doses of IMM-124E did not lead to significant reduction in fat at the end of 24 weeks of therapy. Topline results from this
earlier IMM-124E phase II NASH clinical study were reported in March 2018. The 24-week treatment study which was conducted in Australia,
Israel, and the U.S. involved 133 biopsy-proven NASH patients. The study results demonstrated that IMM-124E, a first-in-class,
oral antibody therapy targeting the endotoxin lipopolysaccharide (LPS) and other bacterial components in the gastrointestinal tract,
resulted in a statistically significant reduction of serum LPS in patients with biopsy proven NASH. IMM-1214E was developed to
target ETEC pathogens, preventing LPS from translocating into the portal circulation. The study results demonstrated a statistically
significant reduction of serum LPS levels in the drug treatment arms when compared to placebo, providing proof-of-concept for a
novel mechanism of action. Serum ALT was also significantly reduced when compared to placebo as well as AST and cytokeratin-18
(CK-18) demonstrating metabolic endotoxemia can be decreased with IMM-124E which can lower serum LPS levels and reduce LPS -associated
liver inflammation. The data showed a small statistically significant reduction in serum lipopolysaccharide (LPS), and reductions
in two biomarkers associated with liver function, but the drug did not display signs of clinical benefit in reducing fat content
of the liver in patients with NASH. Consequently, we decided not to continue clinical development of IMM-124E specifically to treat
NASH. Data from this trial, however, showed that IMM-124E was not systemically absorbed, and the trial provided further support
for IMM-124E’s safety profile, and for its potential use in other therapeutics areas.
Two additional clinical
studies, sponsored and funded by the National Institute of Health, have been performed with IMM-124E: 1) a Phase II clinical study
in patients with severe alcoholic hepatitis (SAH) conducted under FDA IND #015675, and 2) a Phase II clinical study in pediatric
patients with non-alcoholic fatty liver disease (NAFLD) conducted under FDA IND #017066.
Top-line results from
the SAH trial with Dr. Arun Sanyal of Virginia Commonwealth University as the lead Principal Investigator were released on August
8, 2019. The primary objective of this study was to evaluate the safety and efficacy of IMM-124E at two oral dosage levels as
compared with a placebo in patients with severe alcoholic hepatitis and with all patients being treated with steroids. A total
of 57 patients with SAH with a model for end stage liver disease (MELD) score ranging from 21-28 were enrolled into the clinical
study and were treated with either IMM-124E or placebo for 28 days (placebo N=20, IMM-124E 2400 mg/day N=18, IMM-124E 4800 mg/day
N= 19). No suspected unexpected serious adverse reactions were reported and no differences in serious adverse events (SAE)
were observed across the three arms of the study and no SAE was considered related to the study drug by investigators. Both doses
of IMM-124E in the study (2400mg and 4800mg) were well tolerated. There were 9 deaths reported over a six-month period for the
entire cohort and there were no significant differences across study groups. The data showed that IMM-124E is safe to use in patients
with SAH but does not reduce circulating lipopolysaccharide levels, mortality or have an impact on MELD score in the study population,
and we will not continue clinical development of IMM-124E specifically to treat SAH.
The second Phase II clinical
trial involving pediatric patients with NAFLD, which is still undergoing enrollment of patients, is designed to enroll 40 pediatric
patients who are dosed in a three month treatment period. The trial is designed to determine the safety and exploratory efficacy
of IMM-124 in pediatric NAFLD patients. The trial has presently randomized 24 of the targeted 40 patients into the study. The top-line
results for this study are anticipated to be reported in 2020.
Plan to Develop IMM-124E as a Drug to Prevent Travelers’
Diarrhea
On April 11, 2019, we
announced plans to pursue clinical development of IMM-124E through a formal FDA registration pathway as a drug to prevent travelers’
diarrhea. We believe this is an important strategic initiative towards enhancing commercialization of the Travelan/IMM-124E franchise.
Because Travelan and IMM-124E are one and the same, we believe seeking FDA registration for IMM-124E as a drug to prevent travelers’
diarrhea offers the potential for substantial sales benefits to Immuron. We are moving aggressively forward to develop IMM-124E
through the FDA, and on August 20, 2019 we filed with FDA a request for a pre-IND Type B meeting with the agency, with a submitted
IND#145362 application, to discuss the clinical development plan for IMM-124E to prevent travelers’ diarrhea. We believe
that a successful clinical program, followed by a BLA filing with the FDA, and successful FDA approval of IMM-124E to specifically
prevent travelers’ diarrhea could lead to substantial increases in the marketing of what we believe would be the first drug
clinically demonstrated to prevent travelers’ diarrhea.
The Type B meeting with FDA is also planned to provide us with feedback
on the future development program which we hope will enable us to open a Phase 3 registration trial in 2020, establishing the
basis for a future BLA filing of IMM-124E to prevent travelers’ diarrhea.
IMM-529 to Treat Recurrent C. difficile Infections (CDI)
Background on C. difficile
C. difficile
is a gram-positive, toxin-producing, spore-forming bacterium that generally causes severe and persistent diarrhea in infected
individuals, but can also lead to more severe outcomes, including in the most serious cases, death. C. difficile infection
(CDI) is most often associated with the prior use of antibiotics. The U.S. Centers for Disease Control has identified CDI as one
of the top three most urgent antibiotic-resistant bacterial threats in the U.S. and is now the most common cause of hospital acquired
infection in the U.S. CDI is responsible for approximately 29,000 deaths in the U.S. annually. The prevalence of CDI is estimated
at more than 450,000 infections annually, with nearly 100,000 cases of first recurrences. Research suggests that the risk of recurrence
is approximately 25% after the primary occurrence of CDI, 40% after a first recurrence and greater than 60% for those experiencing
two or more recurrences. CDI leads to an increased length of hospitalization and as of 2015, an estimated US$1.1 billion in health
care costs annually in the U.S. The rise of community-acquired CDI is now a growing problem and led to the recognition that CDI
is not simply limited to just hospitals. This increase in CDI incidence, which is now a growing problem worldwide due to the widespread
and increased use of antibiotics, is the driver behind a growing market for C. difficile therapeutics. The CDI market
across the seven major markets of the US, France, Germany, Italy, Spain, the UK and Japan, is set to grow from $630 million in
2016 to almost $1.7 billion by 2026, representing a compound annual growth rate of 10.2%.
C. difficile
can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. In the most serious cases, C.
difficile infections can lead to fulminant colitis, megacolon and even death from colon perforation and peritonitis. C
difficile is acquired from contact with humans or objects harboring these bacteria. It can be commonly acquired during hospitalization.
Up to 30% of those who have spent a prolonged period in the hospital leave carrying these bacteria in the bowel flora, especially
if antibiotics have been administered. This is because CDI is most often associated with the prior use of broad-spectrum antibiotics,
which decrease the natural resistance of the body to C. difficile. Chronic CDI is estimated to occur in perhaps
15-30% of those infected. In some cases, reinfections can occur with the same or with a different strain. Risk factors for relapse
include the number of previous episodes, the need to use antibiotics recurrently, and older age groups.
Human infection occurs
through ingestion of the highly infectious spores which survive acid and bile on their passage into the bowel. Normally, this
infectious process may be eradicated or substantially reduced by the normal bowel flora since the microbes that collectively make
up the flora provide colonization resistance against pathogenic species through competition for essential nutrients and attachment
sites to the gut wall. However, if the bowel flora is suppressed because of concomitant use of antibiotics, or if the bowel flora
has a deficiency, C. difficile can colonize the flora and remain with the patient. In some individuals, it seems
that antibiotics are not required for colonization to take place, which may be related to inadequate defense of the naturally
occurring flora within the bowel.
When C. difficile
takes hold, the toxins produced by the bacterium, especially Toxin B, act by inactivation of Rho GTPases leading to cell death,
and stimulation of an inflammatory cascade that exacerbates tissue damage, diarrhea, and pseudomembranous colitis. When faced
with a CDI infection, the standard of care is typically either a course of vancomycin or metronidazole, both of which are broad
spectrum antibiotics. While these agents are very effective at treating the primary infections, they also severely impact the
rest of the gut flora, creating an ideal environment for the C. difficile spores to once again take hold. This creates
a vicious cycle, as more courses of antibiotic treatments worsen recurrence. Vancomycin and metronidazole treatments are plagued
by increasing rate of CDI recurrences, underscoring the need for new treatments. There is also growing concern of resistance to
vancomycin treatment.
C. difficile
is a very hardy organism most likely because it shed spores and these spores are unable to be eradicated by any known antibiotics.
Since C. difficile spores are able to survive for long periods of time outside of the body, and because healthcare settings
are often sites of significant antibiotic use, CDI transmission rates in hospitals, long-term acute care facilities and nursing
homes have been increasing. CDI is also a cause of morbidity and mortality among hospitalized cancer patients and bone marrow
transplant patients, as their immune systems are suppressed by cytotoxic drugs and sometimes by antibiotics that are administered
to prevent opportunistic infections.
IMM-529 – Novel Triple Action offers a Revolutionary Treatment for Recurrent CDI
Our second lead compound,
IMM-529, targets the C. difficile bacterium and contains polyclonal antibodies cross-reactive to Toxin B, spores
and vegetative cells of the bacterium. IMM-529 is an oral biologic which does not destroy the microbiome like antibiotic treatments,
allowing the microbiome to return to a healthy state, while treating the virulent CDI. The antibodies in IMM-529 have been demonstrated
to be cross-reactive with a variety of human and animal C. difficile isolates and to their associated Toxin B, vegetative
cells and spore components. The antibodies in IMM-529 have also been shown to neutralize Toxin B from a historical C. difficile
strain (630), and from a hypervirulent strain which caused recent worldwide outbreaks.
IMM-529 was developed
and tested extensively in pre-clinical models in collaboration with Dr. Dena Lyras and her team at Monash University, Australia.
Dr. Lyras is one of the world’s foremost experts in C. difficile. IMM-529 targets the virulent Toxin B, the
spores and the vegetative cells. It is a three-pronged approach that is unique and which has yielded promising results in pre-clinical
studies, including (1) prevention of primary disease, (2) treatment of primary disease and (3) suppression of disease recurrence.
To our knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases
of the disease.
Preclinical studies
with IMM-529 yielded promising results in a number of pre-clinical animal models (shown below). All results were highly statistically
significant:
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●
|
Prevention of C. difficile
infection: approximately 70% (17/24) survival vs. 0% survival in the control groups:
|
|
○
|
Control group #1 (0/14) treated with water; and
|
|
○
|
Control group #2 (0/15) treated with non-hyperimmune colostrum.
|
|
●
|
Treatment: approximately 80% survival (11/14) vs. <7% survival in the control groups:
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|
○
|
Control group #1 (0/14): Treated with water alone following vancomycin treatment; and
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|
○
|
Control group #2 (1/15): Treated with non-hyperimmune colostrum following vancomycin treatment.
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|
●
|
Relapse: approximately 90% survival in IMM-529 + vancomycin group (n=7/9); vs. 11% survival in
the control group which received vancomycin alone (n=1/9).
|
The results of these
studies were published in Scientific Reports (Hutton et al. Bovine antibodies targeting primary and recurrent Clostridium difficile
disease are potent antibiotic alternatives), SCI Rep. 2017 Jun 16:7(1):3665.
Phase I/IIa clinical trial of IMM-529 in C. difficile
patients
A first-in-man Phase I/II
clinical trial was initiated at two clinical sites in Israel at the end of 2017 in CDI patients. This trial was intended to evaluate
the safety, tolerability and effectiveness of IMM-529 together with standard of care (SOC) antibiotic treatment in patients with
CDI
On March 19, 2019, we
provided an update regarding the status of the IMM-529 clinical trial in patients with CDI, along with a refocusing of our efforts
to develop IMM-529. The Phase I/II clinical trial of IMM-529 in patients with C. difficile initiated at the end of 2017
at two clinics in Israel provided us with disappointing numbers of enrolled patients. At present, only 9 out of 60 patients have
been randomized into the study and the company has decided to close these sites. We decided to further develop IMM-529 to treat
CDI patients through a formal filing of an IND with FDA, and to develop a new clinical plan for the drug candidate with input from
FDA. The focus for IMM-529 will be to explore how the drug can be developed to determine its impact on reducing recurrent CDI disease,
a major unmet medical need in treatment of patients suffering with C. difficile infections. We are planning to file a Type
B meeting request with FDA to develop IMM-529 to treat patients with CDI.
IMM-529 – Competitive Advantage
We believe that IMM-529
has novel competitive advantages:
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|
Triple Mechanism of Action – IMM-529 not only targets Toxin B, but also contains antibodies to spores and vegetative cells. This is unique among all clinical drug candidates currently in development.
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Effective Against Virulent Strains – As discussed above, IMM-529 has been shown to be effective against a number of virulent strains of CDI, providing a strong proof-of-concept model that IMM-529 can be a frontline agent.
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Effective in All Phases of the Disease – IMM-529 has been shown to be an effective agent in animal models designed to mimic all phases of the disease including prevention of infection, treatment of primary disease and recurrence. This is novel compared to all of our competitors and indicates a much larger potential use for IMM-529 than current development programs which primarily target recurrence.
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Oral Therapy – IMM-529 is an oral therapy lessening costs/burden issues covering patients, hospitals and the healthcare system overall.
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Not an Antibiotic – IMM-529 is not an antibiotic, and only targets components of C. difficile - its Toxin B, spores and vegetative cells. Consequently, IMM-529 is not expected to negatively impact the bacterial flora, allowing the flora to return to normal, while fighting the primary infection / recurrence.
|
Other Development Programs
In addition to the IMM-124E
and IMM-529 programs, we also have two research collaborations with the U.S. Department of Defense (DoD) involving programs with
the U.S. Navy and with the U.S. Army, for the development of two therapeutic products. Specifically one therapeutic program targets
Campylobacter and ETEC, and the second program is focused on the development of Shigella-specific therapeutics. Enterotoxigenic
Escherichia coli is a type of E. coli and is one of the leading bacterial causes of diarrhea in the developing world,
as well as the most common cause of travelers’ diarrhea.
Collaborations with
U.S. Army and U.S. Navy. We believe that our collaborations
with the DoD are a powerful validation of the potential of our platform to develop novel anti-infectives. These collaborations
also open the door to explore and develop potentially low risk / low cost therapeutics with some of the most advanced research
facilities in the world. The DoD earlier commissioned several studies to characterize the polyclonal antibodies contained in Travelan.
The aim was to conduct trials to determine the product’s effectiveness in neutralizing pathogenic GI bacterial infections
as a preventative treatment for U.S. military personnel and civilians stationed or traveling in locations where such infections
can be debilitating.
Armed Forces Research
Institute of Medical Sciences. In June 2016, we signed an agreement with the Walter Reed Army Institute of Research (“WRAIR”)
to develop a therapeutic for a form of dysentery that kills up to one million people a year. WRAIR is the largest and most diverse
biomedical research organization in the DoD.
The project’s aim
is to develop an oral therapeutic for shigellosis, a severe form of dysentery that affects about 165 million people a year, mostly
children, and causes up to a million deaths. Symptoms of shigellosis, also known as bacillary dysentery, include severe and bloody
diarrhea, fever, and stomach cramps. We plan to develop the product for both civilian and military use in areas where endemic diseases
such as shigellosis can compromise the health and readiness of the local community, travelers, contractors and defense personnel.
In January 2018, we reported
that the DoD-commissioned study showed Travelan was immunologically reactive to a number of dangerous and potentially fatal infectious
bacteria. The Department of Enteric Diseases unit of the Armed Forces Research Institute of Medical Sciences (“AFRIMS”)
performed the study. It took place at a WRAIR laboratory in Bangkok, Thailand. The study, one of three involving Travelan, looked
at 60 clinical isolates of each of Campylobacter, ETEC, and Shigella obtained from infected U.S. defense personnel in southeast
Asia between 1993 and 2016. The study indicated that, compared to the control, Travelan antibodies were reactive to all 180 clinical isolates.
In September 2018 we reported
the findings of a study conducted by AFRIMS. The study evaluated the therapeutic potential of Travelan in a non-human primate (“NHP”)
preclinical Shigella challenge model that closely mimics the disease seen in humans. The study was performed in collaboration with
the Department of Enteric Diseases and the Department of Veterinary Medicine, AFRIMS, and the Department of Enteric Infections,
Bacterial Diseases Branch, WRAIR. The placebo-controlled study was carried out in 12 NHPs segregated into 2 groups: a Travelan
treatment cohort of 8 and a placebo cohort of 4, which were treated with either Travelan or placebo respectively twice daily for
a total of 12 doses over a 6-day period. The animals received treatment for 3 days prior to oral challenge with approximately 3
x 109 viable Shigella flexneri strain 2a organisms. All (4 of 4 - 100%) placebo-treated animals displayed acute
dysentery symptoms within 24 to 36 hours of the Shigella flexneri 2a challenge. Seven of the eight individuals in the Travelan
treatment cohort (87.5%) remained symptom-free to 4 days post the Shigella flexneri 2a challenge. Only one of the Travelan-treated
cohort displayed dysentery symptoms during the same time frame as the placebo arm. Once the treatment period was concluded a second
individual in the Travelan treatment group developed symptoms. Six of the eight Travelan treated cohort animals remained symptom-free
to the conclusion of the study which was 11 days post the Shigella flexneri 2a challenge.
In June 2019 we updated
the market on the latest developments arising from our cooperative research and development efforts with the DoD. AFRIMS completed
the histopathological analysis, which provides a comprehensive view of the clinical disease
and its effect on tissues of gut, revealed that all animals in the placebo-treated group displayed severe inflammation in
different parts of the gastrointestinal tract. These animals also had very high levels of inflammatory cytokines (IL-1b, IL-6 and
IL-8) in fecal samples collected throughout the study. The inflammation seen in the gastrointestinal tract and the increase in
inflammatory cytokines in the feces were closely associated with the observed clinical outcomes of dysentery. Only 3 of the 8 Travelan-treated
animals had signs of inflammation in the gastrointestinal tract, and only 2 of those had high levels of inflammatory cytokines
in fecal samples. All other animals in the Travelan-treated group were clinically healthy and did not excrete any inflammatory
cytokines. Overall the results suggest that Travelan® is functionally cross-reactive and may have prophylactic activity against
Shigellosis.
In June 2019 we also reported
the completion of the manufacture of three new Shigella-specific therapeutic products using proprietary vaccines developed
by WRAIR. The immune reactivity of the three hyper-immune Shigella specific products were evaluated by the WRAIR using Enzyme-Linked ImmunoSorbent Assay and
Western Blot analysis. The antibodies in the products were shown to react with the specific antigens present in the vaccines. The
antibodies within the three products were also reactive to 4 different clinical isolates of Shigella (S. flexneri 2a, S.
flexneri 3a, S. flexneri 6, and S. sonnei). The three Immuron Shigella-specific therapeutic products will
now go on to evaluation in WRAIR’s preclinical models of shigellosis.
In September 2019 we
announced the results of the study, sponsored by the DoD and funded through the Defense Health Agency, which was performed at
the overseas laboratory of the WRAIR located in Bangkok, Thailand. The goal was to investigate the breadth of Travelan®’s
immunological reactivity against pathogenic Vibrio cholera bacterial isolates. Clinical isolates were collected from infected
personnel located in Bangladesh, Cambodia, and Thailand, enabling researchers to gauge Travelan®’s potential against
bacterial strains typically seen in the field. When compared to a placebo control, researchers found that the polyclonal antibodies
comprising Immuron’s Travelan® product were reactive to all 71 clinical isolates from these infected individuals. The
ability of Travelan® to bind these bacteria highlights the broad-spectrum recognition by Travelan® of surface antigens
on potentially debilitating and even life-threatening bacteria.
U.S. Naval Medical
Research Center (“NMRC”). In August 2016, we signed an agreement with the U.S. Navy to test the reactivity and
therapeutic effectiveness of Travelan against Campylobacter and ETEC, two common gram-negative bacteria. A subsequent study demonstrated
Travelan bound to and neutralized key components used by ETEC bacteria to attach to host cells and cause disease. This study was
performed by the NMRC’s Department of Enteric Infections and reported that Travelan was specifically shown to:
|
●
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React with the major colonization factor antigens;
|
|
●
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Bind to key fimbrial proteins which are used by the bacteria to attach to host cells and cause
disease;
|
|
●
|
Inhibit the bacteria binding and causing cell hemagglutination; and
|
|
●
|
React with the heat labile enterotoxin produced by ETEC bacteria.
|
In October 2019, we announced
that the U.S. Department of Defense had approved USD $3.7 million in funding in connection with a new research agreement with the
Naval Medical Research Center (NMRC), Silver Spring, MD, USA to develop and clinically evaluate a new oral therapeutic targeting
Campylobacter and ETEC. The focus of this new agreement will be to develop a combined Campylobacter and enterotoxigenic E. coli
(ETEC)-specific anti-microbial preventative for clinical evaluation. Under this agreement, Immuron and NMRC will be collaborating
on the manufacture and evaluation of the new product designed to protect against travelers’ diarrhea caused by Campylobacter
and ETEC pathogens. The protective efficacy of the product will be tested utilizing two controlled human infection-model clinical
trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis,
and the second trial focusing on ETEC infections.
Campylobacter’s
main reservoir is poultry; however, humans can contract the disease from contaminated food. At least a dozen species of Campylobacter
have been implicated in human disease, with C. jejuni and C. coli being the most common. C. jejuni is now
recognized as one of the main causes of bacterial foodborne disease in many developed countries as well as developing countries
where poultry is common.
ETEC is one of the
leading bacterial causes of diarrhea in the developing world, as well as the most common cause of travelers’ diarrhea. Conservative
estimates suggest that each year, about 157,000 deaths occur, mostly in children, from ETEC, but no vaccines exist, highlighting
the need for new treatment modalities.
Accordingly, we believe
that the breadth and depth of our technology, and the support we are receiving from the NIH, the DoD and other leading institutions
and Key Opinion Leaders, demonstrates the importance of our technology platform, and makes us truly a unique and attractive player
in the therapeutic areas we are targeting.
OUR ADVISORY BOARD
Our company’s
programs are supported by an advisory board consisting of:
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●
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Dr. Arun Sanyal (MD) – University of Virginia. Professor of Medicine and Former Chairman
of the Division of Gastroenterology, Hepatology and Nutrition, VCU Medical Center. Dr. Sanyal is an internationally renowned expert
in liver diseases. He is a former President of the American Association for the Study of Liver Diseases and is the current Chair of the Liver Study Section at the NIH.
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Dr. Stephen Harrison (MD) – Professor of Medicine, Uniformed Services University of the Health
Sciences, Bethesda, Maryland; Physician, San Antonio Military Medical Center, Fort Sam Houston, San Antonio, Texas. Chief of Residents,
Internal Medicine, Brooke U.S. Army Medical Center. Dr. Harrison is an internationally renowned expert in NASH and his group has
published seminal work on many aspects in the field. Dr. Harrison is the Principal Investigator of Galectin’s GR-MD-02’s
Phase 2 trial and hold’s key roles in other leading clinical NASH studies.
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Dr. Miriam Vos (MD) – Emory University. Dr. Vos is an associate professor of pediatrics at
the Emory University School of Medicine, and an attending Hepatologist at Children’s Healthcare of Atlanta. She specializes
in the treatment of GI disease in children as well as fatty liver disease and obesity. Dr. Vos is also the author of The No-Diet
Obesity Solution for Kids.
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Dr.
Dena Lyras (PhD) – Monash University. Dr. Lyras, an associate professor at Monash
University, is one of the world’s leading experts in C. difficile. Dr. Lyras
has spent her research career developing world-leading knowledge of C. difficile.
She was the lead author of a seminal study published in Nature in 2009, which shed new
light on the essential role specific toxins play in causing disease, a discovery that
disproved prevailing opinion.
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Dr.
Manal Abdelmalek (MD) – Duke University Medical Center. Dr. Abdelmalek is Associate Professor
of Medicine at Duke Medical University Medical Center, Division of Gastroenterology & Hepatology,
Section of Hepatobiliary Diseases & Liver Transplantation. Dr. Abdelmalek is a leading investigator
in the field of NASH.
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Dr.
Gerhard Rogler (MD, PhD) – Zurich University. Dr. Rogler was the principal investigator
of our Colitis preclinical program. He ceased to be a member of our advisory board when
the scientific results were published on January 25, 2019. Dr. Rogler is the Chairman
of the Scientific Advisory Board of the University of Zurich and Professor of Gastroenterology
and Hepatology and Consultant Gastroenterologist at the Division of Gastroenterology
& Hepatology, Department of Medicine, Zürich University Hospital, Switzerland.
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OUR MARKETED ASSETS
Travelan –
Our Flagship Commercial Asset. Travelan, our over-the-counter gastrointestinal and digestive health supplement,
reported increased sales of 28.5% year over year for the 2019 financial year, achieving AUD $2.3M total sales. Travelan
is currently marketed in Australia, the U.S., and Canada. In Australia, Travelan® is a listed medicine on the Australian Register
of Therapeutic Goods (AUST L 106709), and is indicated to reduce the risk of Travelers’ Diarrhea, reduce the risk of minor
gastro-intestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health product (NPN 80046016)
and is indicated to reduce the risk of Travelers’ Diarrhea. In the U.S., Travelan® is sold as a dietary supplement for
digestive tract protection in accordance with section 403 (r)(6) of the FDA.
Australian sales revenue
for Travelan for the 2019 financial year was AUD $1.16M, showing continued growth and a 12% increase compared to the 2018 fiscal
year. Increased initiatives in the pharmacy sector, including TV advertising with Chemist Warehouse and stronger merchandising
in-store, contributed to this sales momentum.
In the United States,
Travelan sales also increased with fiscal year 2019 revenue exceeding the AUD $1M milestone for the first time, as sales grew by 32% year over year. The increase in sales, reaching AUD $1.02M for the 2019 fiscal year, was mainly thanks to the partnership
with Passport Health, America’s largest travel medicine network, and rising sales on the Amazon platform. During fiscal year 2019, we were featured in two podcasts on the US based ‘Not Old, Better’ channel. This included an interview with Dr.
Hailey Weerts from the US Department of Defense, in which she spoke of the ground-breaking research into Travelan by WRAIR. Both
podcasts resulted in an immediate spike in sales of Travelan on Amazon, with this online category growing by almost 80% in fiscal year 2019.
May 2019 also represented a record-breaking month for Travelan sales, with revenue climbing to $182K in the United States.
In April 2019 we relaunched Travelan in Canada, with ANB Canada managing marketing and distribution in the retail pharmacy sector. The major Canadian
Pharmacy chain Shoppers Drug Mart was the first banner to range the product.
Overall, over 50 million
people from developed nations travel to developing countries each year, 35%-50% of people traveling to developing countries will
suffer from travelers’ diarrhea, and 70% of those episodes will be caused by ETEC. Travelers’ diarrhea is the most
common health problem faced by these travelers; given this, we believe that an expanded sales and marketing campaign for Travelan
would lead to a strong increase in sales. We are in the process of finding partners for other priority markets outside of Australia,
the U.S., and Canada.
OVERVIEW OF TECHNOLOGY
We are a clinical-stage
Australian biopharmaceutical company with a proprietary technology platform focused on developing a novel class of biological polyclonal
antibodies that can address significant unmet medical needs. Our primary focus is on developing first-in-class oral polyclonal
antibodies drugs to treat a range of infectious diseases. Compared to other therapeutics, our oral polyclonal antibodies offer
targeted delivery within the gastrointestinal track and do not cross into the bloodstream, potentially leading to much improved
safety and tolerability.
The underlying nature
of our platform technology enables the development of medicines across a large range of infectious diseases. The platform can
be used to directly block viruses or bacteria at mucosal surfaces (such as the GI tract) and neutralize the toxins they produce.
Additionally, the dairy origins of our antibodies enable us to commercialize our platform through most regulatory pathways, including
prescription, medical foods, over-the-counter medicines, and dietary supplements.
Manufacturing Process
Our active pharmaceutical
ingredients are manufactured under cGMP conditions and many of the components are the same as those of normal cow’s milk.
However, the main differentiation between milk and our active ingredient constituents is the presence of antibodies in bovine colostrum
of the order of 35-45% by weight of dry colostrum powder. The main classes of immunoglobulins found in the active ingredient are
IgG with smaller amounts of IgM and IgA. The major class of immunoglobulin G found in bovine colostrum is IgG1 making up between
65% and 90% of total immunoglobulins, in contrast to milk which comprises predominantly IgA.
Vaccination
The active drug substance
is prepared using the first milking colostrum of dairy cows that have been immunized with patented vaccines to produce very high
levels of specific antibodies against selected surface antigens. Pregnant dairy cows at commercial dairy farms are immunized through
a proprietary process.
Colostrum
The colostrum is harvested
from immunized Holstein Friesian and Jersey cows registered for milk production for human consumption and at the time of harvesting
are free from antibiotics. They are not given steroids at any stage of the process. Colostrum is harvested at the first milking
which will be within twelve hours of calving, leaving plenty for the calf to feed on.
Once harvested, preparation
of the active ingredient complies with processes that are regulated by Dairy Safe standards in addition to the TGA, which is a
Federal requirement and known globally for its stringent criteria. The raw colostrum material is centrifuged using a milk separator
to remove somatic cells, cell debris, some bacteria and fat. It is then pasteurized, cooled and subjected to membrane ultra-filtration,
removing much of the water, salts and lactose. The colostrum wet concentrate is then spray dried to produce a powder, which is
milled to 200 microns. The processes are typical for the dairy industry and for production of dairy foods. After spray drying,
the active ingredient is ready for further processing into the oral dosage form.
Tableting
The
product excipients are all standard, FDA acceptable oral compounds that are granulated, milled and finally compressed into caplets
and blister packaged (pharmaceutical grade packaging materials).
Batch Consistency
The
IgG component of our active ingredient ranges between 36% and 45%. The parameters are stable within batches and across batches.
Our product is stable according to ICH guidelines and the IgG component of our active ingredient is stable over time and is manufactured
under cGMP conditions with all associated QA and QC processes ensuring the stability of these parameters.
Trademarks
We have rights to trademarks
and trade names (both registered and unregistered) used in this Annual Report on Form 20-F (this “Annual Report”) which
are important to our business.
These trademarks are as follows:
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●
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Immuron (registration in U.S.);
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|
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|
Travelan (registration in U.S., Australia and China); and
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|
●
|
Protectyn (registration in Australia and Europe);
|
Solely for convenience,
trademarks and trade names referred to in this Annual Report appear without the “®” or “™”
symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent possible
under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend
our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement
or sponsorship of us by, any other companies. Each trademark, trade name or service mark of any other company appearing in this
Annual Report is the property of its respective holder.
PATENTS
We
have a policy to identify, capture and protect all relevant intellectual property associated within our core business strategies.
We own a number of patent families that have been filed to protect both the vaccine that is used to generate our colostrum enriched
with antibodies of choice, as well as methods of treating certain conditions with the resulting hyper-immune colostrum.
Our
patent rights are supplemented by a comprehensive body of confidential and proprietary expertise that has been developed over many
years and relates to the methods of production of the hyper-immune colostrum. These trade secrets include information relating
to a low cost production system and an effective immunization process that is approved by an independent animal ethics committee.
During the year ended June 30, 2019, we continued to
expand our patent portfolio in various global jurisdictions.
A summary of our principal patent families is set out
in the table below:
Number
|
|
Country
|
|
Status
|
|
Expiry
|
Composition and Method for the Treatment and Prevention of Enteric Bacterial Infections
|
2004216920
|
|
Australia
|
|
Granted
|
|
March 4, 2024
|
0408085-8
|
|
Brazil
|
|
Pending
|
|
March 4, 2024
|
2,517,911
|
|
Canada
|
|
Granted
|
|
March 4, 2024
|
201210055406.0
|
|
China
|
|
Pending
|
|
March 4, 2024
|
EP 16020270.1
|
|
Europe
|
|
Pending
|
|
March 4, 2024
|
230664 B
|
|
India
|
|
Granted
|
|
March 4, 2024
|
542088
|
|
New Zealand
|
|
Granted
|
|
March 4, 2024
|
9,402,902
|
|
USA
|
|
Granted
|
|
March 4, 2024
|
8,637,025
|
|
USA
|
|
Granted
|
|
February 25, 2028
|
|
|
|
|
|
|
|
Anti LPS Enriched Immunoglobulin Preparation for use in Treatment and/or Prophylaxis of a Pathologic Disorder
|
2010243205
|
|
Australia
|
|
Granted
|
|
April 27, 2030
|
2760096
|
|
Canada
|
|
Granted
|
|
April 27, 2030
|
13/265,252
|
|
USA
|
|
Granted
|
|
April 27, 2030
|
2424890
|
|
Europe
|
|
Granted
|
|
April 27, 2030
|
12103554.8
|
|
Hong Kong
|
|
Granted
|
|
April 27, 2030
|
315924
|
|
Israel
|
|
Granted
|
|
April 27, 2030
|
5740390
|
|
Japan
|
|
Granted
|
|
April 27, 2030
|
10-2011-7027634
|
|
Korea
|
|
Granted
|
|
April 27, 2030
|
335793
|
|
Mexico
|
|
Pending
|
|
April 27, 2030
|
201171304
|
|
Eurasia
|
|
Granted
|
|
April 27, 2030
|
|
|
|
|
|
|
|
Anti LPS Enriched Immunoglobulin Preparation for use in Treatment and/or Prophylaxis of a Pathologic Disorder
|
2011290478
|
|
Australia
|
|
Granted
|
|
April 27, 2030
|
2808361
|
|
Canada
|
|
Pending
|
|
April 27, 2030
|
2605791
|
|
Europe
|
|
Granted
|
|
April 27, 2030
|
13/817,414
|
|
USA
|
|
Granted
|
|
April 27, 2030
|
1185016
|
|
Hong Kong
|
|
Granted
|
|
April 27, 2030
|
|
|
|
|
|
|
|
Methods and Compositions for the Treatment and/or Prophylaxis of Clostridium Difficile Associated Disease
|
2014253685
|
|
Australia
|
|
Accepted
|
|
April 17, 2034
|
2,909,636
|
|
Canada
|
|
Pending
|
|
April 17, 2034
|
2986316
|
|
Europe
|
|
Pending
|
|
April 17, 2034
|
14/785,527
|
|
USA
|
|
Granted
|
|
April 17, 2034
|
201480034857.3
|
|
China
|
|
Pending
|
|
April 17, 2034
|
713233
|
|
New Zealand
|
|
Pending
|
|
April 17, 2034
|
REGULATORY CONSIDERATIONS
Our clinical assets
are considered as biologics by the FDA, conferring 12 years of market exclusivity from date of approval in the U.S. for approved
drugs derived from our technology program. New products in Europe have 10 years of market exclusivity.
Our
ongoing research and development activities are, and the production and marketing of our pharmaceutical product candidates derived
from those activities will be, subject to regulation by human research ethics committees and institutional research boards, as
well as numerous governmental authorities in Australia, principally the TGA, the FDA in the U.S., the MHRA in the United Kingdom
and the EMA in Europe. Prior to marketing, any therapeutic product developed must undergo rigorous pre-clinical testing and clinical
trials, as well as an extensive regulatory approval process mandated by the TGA and, to the extent that any of our pharmaceutical
products under development are marketed abroad, by foreign regulatory agencies, including the FDA, EMA and MHRA.
Clinical
trials can take many years to complete and require the expenditure of substantial resources. The length of time varies substantially
according to the type, complexity, novelty and intended use of the product candidate. We cannot make any assurances that once clinical
trials are completed by us or a collaborative partner, we will be able to submit as scheduled a marketing approval request to the
applicable governmental regulatory authority, or that such request and application will be reviewed and cleared by such governmental
authority in a timely manner, or at all. Although we intend to make use of fast-track and abbreviated regulatory approval programs
when possible and commercially appropriate, we cannot be certain that we will be able to obtain the clearances and approvals necessary
for clinical testing or for manufacturing and marketing our pharmaceutical products candidates. Delays in obtaining regulatory
approvals could adversely affect the development and commercialization of our pharmaceutical product candidates and could adversely
impact our business, financial condition and results of operations.
During
the course of clinical trials and non-clinical studies, including toxicology studies, product candidates may exhibit unforeseen
and unacceptable drug-related toxicities or side effects. If any unacceptable toxicities or side effects were to occur, we may,
or regulatory authorities may require us to, interrupt, limit, delay or abort the development of our potential products. In addition,
unacceptable toxicities could ultimately prevent the clearance of our product candidates by human research ethics committees, institutional
research boards, the TGA, EMA, FDA or other regulatory authority for any or all targeted indications. Even after being cleared
by a regulatory authority, any of our products may later be shown to be unsafe or not to have its purported effect, thereby preventing
widespread use or requiring withdrawal from the market. We cannot make any assurances that IMM-124E, IMM-529 or any other development
or product candidate will be safe or effective when administered to patients.
ORGANIZATIONAL STRUCTURE
We have three wholly-owned
subsidiaries, Immuron Inc., Anadis EPS Pty Ltd (formed for the sole purpose to act as trustee for the Immuron Limited Executive
Officer Share Plan Trust) and IMC Canada Ltd. All costs associated with the operations of these companies are borne by Immuron
Limited. Anadis ESP Pty Ltd does not form a part of the consolidated accounts as they are not material.
PROPERTY, PLANT AND EQUIPMENT
Our corporate
headquarters are located at Level 3, 62 Lygon Street, Carlton South, Victoria, 3053, Australia and consist of
approximately 1,000 square feet of office space (which is provided as part of a services agreement which expires at-will upon
six months written notice). Our principal office is located at Suite 10-25 Chapman Street, Blackburn North, Victoria 3130 and
consists of approximately 1,500 square feet of leased office and warehouse space under a lease agreement which is expiring in
December 2021, with an ongoing further three-year option for extension. We have no dedicated research and development
facility as our research and development activities are provided by third party suppliers who are responsible for their own
premises. We believe that our existing facilities are adequate for our current needs.
ITEM 4A. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
The following discussion
and analysis includes certain forward-looking statements with respect to the business, financial condition and results of operations
of our company. The words “estimate,” “project,” “intend,” “expect” and similar
expressions are intended to identify forward-looking statements within the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those
contemplated by such forward-looking statements, including those risk factors contained in Item 3.D. of this Annual Report. You
should read the following discussion and analysis in conjunction with our consolidated financial statements and the notes thereto
included in this Annual Report.
A. Operating Results
Background
We were incorporated under
the laws of Australia in 1994 and have been listed on the ASX since April 30, 1999. Our ADSs and Warrants have traded on The NASDAQ
Capital Market since June 13, 2017.
Our consolidated financial
statements appearing in this annual report comply with IFRS as issued by IASB. In this annual report, all references to “U.S.
dollars” or “US$” are to the currency of the U.S., and all references to “Australian dollars”, “A$”
or “AUD$” are to the currency of Australia. All of our revenues are generated in Australian dollars, United States
dollars and Canadian dollars, and the majority of our expenses are incurred in Australian dollars.
Critical Accounting Policies
The
following is a summary of the material accounting policies adopted by us in the preparation of the financial report. The accounting
policies have been consistently applied, unless otherwise stated.
Basis of Consolidation
The
consolidated financial statements incorporate the financial statements of our company and the entities controlled by us (our subsidiaries)
referred to as “the group” or “the Group” in the financial statements. Control is achieved where the consolidated entity 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 to direct the activities of the entity.
A
list of controlled entities is contained in note 10 to the financial statements. All controlled entities have a June 30 financial
year-end. All intra-group transactions, balances, income and expenses are eliminated in full on consolidation. Accounting policies
of subsidiaries have been changed where necessary to ensure consistency with those policies applied by the parent entity. Subsidiaries
are accounted for at cost in the parent entity.
Revenue Recognition
Sale of hyperimmune products
Revenue from the sale of hyperimmune products
are recognized at a point in time. The performance obligation is satisfied when the customer has access and thus control of the
product.
Financing components
The group does not expect
to have any contracts where the period between the transfer of the promised goods or services to the customer and payment by the
customer exceeds one year. As a consequence, the group does not adjust any of the transaction prices for the time value of money.
Previous accounting policy for revenue recognition
Revenue is measured at the fair value of the
consideration received or receivable. Amounts disclosed as revenue are net of returns, trade allowances, rebates and amounts collected
on behalf of third parties.
The Company recognizes revenue when the amount
of revenue can be reliably measured, it is probable that future economic benefits will flow to the entity and specific criteria
have been met for each of the Company’s activities. The amount of the revenue is not considered to be reliably measured until all
contingencies relating to the sale have been resolved.
Fair value of R&D tax incentive
The
group’s research and development (R&D) activities are eligible under an Australian government tax incentive for
eligible expenditure. Management has assessed these activities and expenditure to determine which are likely to be eligible
under the incentive scheme. Amounts are recognized when it has been established that the conditions of the tax incentive have
been met and that the expected amount can be reliably measured. For the year ended June 30, 2019, the group has included an
item in other income of $531,005 (2018: $1,849,123) to recognize income over the period necessary to match the grant on a
systematic basis with the costs that they are intended to compensate.
Intangible Assets – Research & Development
Expenditure
on research activities, undertaken with the prospect of obtaining new scientific or technical knowledge and understanding, is recognized
in the statement of profit or loss and other comprehensive income as an expense when it is incurred.
Expenditure
on development activities, being the application of research findings or other knowledge to a plan or design for the production
of new or substantially improved products or services before the start of commercial production or use, is capitalized if it is
probable that the product or service is technically and commercially feasible, will generate probable economic benefits and adequate
resources are available to complete development and cost can be measured reliably. Other development expenditure is recognized
in the statement of profit or loss and other comprehensive income as an expense as incurred.
Interest Bearing Loans and
Borrowings
Generally,
loans and borrowings are initially recognized at cost, being the fair value of the consideration received net of issue costs associated
with the borrowing. After initial recognition, interest bearing loans and borrowings are subsequently measured at amortized cost
using the effective interest method. Amortized cost is calculated by taking into account any issue costs and any discount or premium
on settlement.
Inventories
Raw
materials, work in progress and finished goods are stated at the lower of cost and net realizable value. Cost comprises direct
material, freight and import duty. Management classifies a portion of inventory as a current asset based on an assessment of expected
use in the next 12 months. The remainder is classified as a non-current asset.
Costs
are assigned to individual items of finished goods inventory on basis of weighted average costs. Net realizable value is the estimated
selling price in the ordinary course of business less the estimated costs of completion and the estimated costs necessary to make
the sale.
Share-based payments
Share-based
compensation benefits may be provided through the issue of fully paid ordinary shares under the Immuron Employee Share and Option
Plan (“ESOP”). Options are also granted to employees and consultants in accordance with the terms of their respective
employment and consultancy agreements. Any options granted are made in accordance with the terms of our ESOP.
The
fair value of options granted under employment and consultancy agreements are recognized as an employee benefit expense with a
corresponding increase in equity. The fair value is measured at grant date and recognized over the period during which the employees
become unconditionally entitled to the options.
The
fair value at grant date is determined using a Black-Scholes option pricing model that takes into account the exercise price, the
term of the option, the vesting and performance criteria, the impact of dilution, the non-tradable nature of the option, the share
price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk-free interest
rate for the term of the option.
The
fair value of the options granted excludes the impact of any non-market vesting conditions (for example, profitability and sales
growth targets). Non-market vesting conditions are included in assumptions about the number of options that are expected to become
exercisable. At each reporting date, the entity revises its estimate of the number of options that are expected to become exercisable.
The employee benefit expense recognized each period takes into account the most recent estimate. The impact of the revision to
original estimates, if any, is recognized in the statement of profit or loss and other comprehensive in come with a corresponding
adjustment to equity.
Upon the exercise
of options, the balance of the share-based payments reserve relating to those options is transferred to contributed equity.
Critical Accounting Estimates
and Judgments
Management
evaluates estimates and judgments incorporated into the financial statements based on historical knowledge and best available current
information. Estimates assume a reasonable expectation of future events and are based on current trends and economic data, obtained
both internally and externally.
Share-based payments
The
value attributed to share options and remunerations shares issued is an estimate calculated using an appropriate mathematical formula
based on an option pricing model. The choice of models and the resultant option value require assumptions to be made in relation
to the likelihood and timing of the conversion of the options to shares and the value of volatility of the price of the underlying
shares.
Impairment of inventories
The
provision for impairment of inventories assessment requires a degree of estimation and judgement. The level of the provision is
assessed by taking into account the recent sales experience, the ageing of inventory, and in particular, the shelf life of inventories
that affects obsolescence. Expected shelf-life is reassessed on a regular basis with reference to stability tests which are conducted
by an expert engaged by the Company.
Inventory split
During
the current financial period, management has performed an assessment on its raw materials and their utilization within 12 months
from reporting date and have determined A$225,765 (2018: A$198,585) of raw materials relating to Colostrum is expected to be consumed
within 12 months and the remaining balance of A$1,862,063 (2018: A$2,171,867) is expected to be consumed after 12 months from reporting
date.
During
the year ended June 30, 2018, management determined that a portion of its inventory should be reclassified on a prospective basis
as a noncurrent asset as a result of a strategic decision made by management in the intended use of its inventory. The Company
decided to terminate all plans to sell the colostrum powder to secondary markets as a result of the continued scientific evidence
supporting an extended shelf life. The extended shelf life provides the Company with the assurance that colostrum will be consumed
through the production of its current Travelan and Protectyn products throughout future reporting periods.
Provision for employee benefits
Provision
for employee benefits represents amounts accrued for annual leave and long service leave. The current portion for this provision
includes the total amount accrued for annual leave entitlements and the amounts accrued for long service leave entitlements that
have vested due to employees having completed the required period of service. Refer to note 1(q) for policies on provisions.
R&D tax incentive
The
Group’s research and development activities are eligible under an Australian Government tax incentive for eligible
expenditure from July 1, 2011. Management has assessed these activities and expenditure to determine which are likely to be
eligible under the incentive scheme.
For the year
ended June 30, 2019 the Group has recorded other income of A$531,005 (2018: A$1,849,123) to recognize this amount which
relates to this financial year.
Fair value measurement hierarchy
The
preparation of the financial statements requires management to make judgments, estimates and assumptions that affect the reported
amounts in the financial statements. Management continually evaluates its judgments, estimates in relation to assets, liabilities,
contingent liabilities, revenue and expenses. Management bases its judgments, estimates, and assumptions on historical experience
and on other various factors, including expectations of future events, management believes to be reasonable under the circumstances.
The resulting accounting judgments and estimates will seldom equal the related actual results. The judgments, estimates and assumptions
that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next
financial year are discussed within the relevant sections where applicable.
The fair value of
the convertible notes classified as Level 3 were determined by the use of valuation model. These include discounted cash flow
analysis and the use of observable inputs that required significant adjustments based on unobservable inputs.
Results of Operations
The
following discussion relates to our consolidated results of operations, financial condition and capital resources. You should read
this discussion in conjunction with our consolidated financial statements and the notes thereto contained elsewhere in this Annual
Report.
Comparison of the fiscal
years ended June 30, 2019 and 2018
|
|
For the fiscal year ended
|
|
|
|
|
|
|
June 30,
|
|
|
Increase/
|
|
|
|
2019
|
|
|
2018
|
|
|
(Decrease)
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from contracts with customers
|
|
|
2,387,426
|
|
|
|
1,842,909
|
|
|
|
544,517
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Australian Federal R&D tax concession refund
|
|
|
531,005
|
|
|
|
1,849,123
|
|
|
|
(1,318,118
|
)
|
Other income
|
|
|
1,045
|
|
|
|
40
|
|
|
|
1,005
|
|
Total Other Income
|
|
|
532,050
|
|
|
|
1,849,163
|
|
|
|
(1,317,113
|
)
|
Revenues
received from the sale of goods increased by A$544,517, or 30%, from fiscal 2018 to fiscal 2019, primarily due to the sales growth
in the Australian, U.S. and North American markets for Travelan products. We anticipate that revenues from sales of our Travelan
product will increase in the future.
Our
R&D tax concession income recognized during fiscal 2019 decreased by A$1,318,118 compared to fiscal 2018. The overall decrease
is attributed to a decrease in R&D tax concession expenditure relating to eligible research and development.
Other (residual) income,
which is interest income, increased by A$1,005 in fiscal 2019, primarily due to an increase in cash and cash equivalents.
Cost of Goods Sold and
Gross Profit
|
|
For the fiscal year ended
|
|
|
|
|
|
|
June 30,
|
|
|
Increase/
|
|
|
|
2019
|
|
|
2018
|
|
|
(Decrease)
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
Revenue from contracts with customers
|
|
|
2,387,426
|
|
|
|
1,842,909
|
|
|
|
544,517
|
|
Cost of Goods Sold
|
|
|
(667,371
|
)
|
|
|
(418,693
|
)
|
|
|
248,678
|
|
Gross Profit
|
|
|
1,720,055
|
|
|
|
1,424,216
|
|
|
|
295,839
|
|
Our key manufacturing
partners provide us with steady, reliable product at a known price which from a strategic point of view provides us with certainty
around the manufacturing margins. The Company’s cost of goods sold margin was broadly maintained year on year with a slight
increase to 28% in fiscal 2019 from 23% in fiscal 2018. As we expand our sales efforts in North America, we have been able to maintain
economies of scale thereby broadly maintaining our cost of goods sold margins.
Expenses
|
|
For the fiscal year ended
|
|
|
|
|
|
|
June 30,
|
|
|
Increase/
|
|
|
|
2019
|
|
|
2018
|
|
|
(Decrease)
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
|
5,014,128
|
|
|
|
3,412,576
|
|
|
|
1,601,552
|
|
Research and development expenses
|
|
|
1,044,528
|
|
|
|
2,257,224
|
|
|
|
(1,212,696
|
)
|
Selling and marketing expenses
|
|
|
864,644
|
|
|
|
686,714
|
|
|
|
177,930
|
|
Total expenses
|
|
|
6,923,300
|
|
|
|
6,356,514
|
|
|
|
566,786
|
|
General and administrative
expenses. General and administrative expenses increased by A$1,601,552 from fiscal 2018 to fiscal 2019. The increase is mainly
attributed to the share-based payments made to employees, consultants and directors of the Company amounting to A$1,343,500 in
fiscal 2019 compared to $A59,975 in fiscal 2018 and the appointment of Dr Gary S. Jacob and Mr Richard Jay Berman during fiscal
2019.
“Furthermore,
of the A$1,343,500 share-based payments expenses recognized during fiscal 2019, A$1,139,400 relates to the value of the options
granted to Dr Gary S. Jacob and Mr Richard Jay Berman which did not result in an actual allocation of shares.” The exercise
price of the options is $0.50 per share.
Research
and development expenses. Research and development expenses decreased by A$1,212,696 from fiscal 2018 to fiscal 2019. The
reduction in the research and development expenditure reflects the Company’s new strategic focus and development pipeline
during fiscal 2019.
Selling and marketing
expenses. Selling and marketing expenses increased by A$177,930 from fiscal 2018 to fiscal 2019 as we increased our promotional
efforts for Travelan, our existing flagship consumer product.
Loss
for the period. As a result of the foregoing, our loss for the period after income tax benefit increased by A$1,621,814, or
54%, from A$3,010,929 in fiscal 2018 to A$4,632,743 in fiscal 2019.
Given
our, and our subsidiaries’, history of recent losses, we have not recognized a deferred tax asset with regard to unused tax
losses and other temporary differences, as it has not been determined whether we, or our subsidiaries, will generate sufficient
future taxable income against which we can utilized these unused tax losses and any uncalculated potential deferred tax assets,
together with any other temporary differences. Should the need arise, we can, and will, revisit this position.
Comparison
of the fiscal years ended June 30, 2018 and 2017
Revenue and Other income
|
|
For the fiscal year ended
|
|
|
|
|
|
|
June 30,
|
|
|
Increase/
|
|
|
|
2018
|
|
|
2017
|
|
|
(Decrease)
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from contracts with customers
|
|
|
1,842,909
|
|
|
|
1,396,197
|
|
|
|
446,712
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Australian Federal R&D Tax Concession Refund
|
|
|
1,849,123
|
|
|
|
1,575,315
|
|
|
|
273,808
|
|
Other income
|
|
|
40
|
|
|
|
30,672
|
|
|
|
(30,632
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Income
|
|
|
1,849,163
|
|
|
|
1,605,987
|
|
|
|
243,176
|
|
Revenues
received from the sale of goods increased by A$446,712, or 32%, from fiscal 2017 to fiscal 2018, primarily due to the sales growth
in the Australian and U.S. markets for Travelan products. We anticipate that revenues from sales of our Travelan product will increase
in the future.
Our
R&D tax concession income recognized during fiscal 2018 increased by A$273,808 compared to fiscal 2017. The overall increase
is attributed to the combination of an additional A$658,094 R&D tax concession income relating to eligible research and development
expenditure being incurred during fiscal 2017 that was recognized in fiscal 2018 and a net decrease of A$384,286 being the difference
between the research and development accrual recognized in fiscal 2018 compared to fiscal 2017.
Other (residual) income decreased by A$30,632 in
fiscal 2018, primarily due to a one-off industry grant received in fiscal 2017.
Cost of Goods Sold, Gross Profit and Direct
Selling Costs
|
|
For the fiscal year ended
June 30,
|
|
|
Increase/
|
|
|
|
2018
|
|
|
2017
|
|
|
(Decrease)
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
Revenue from contracts with customers
|
|
|
1,842,909
|
|
|
|
1,396,197
|
|
|
|
446,712
|
|
Cost of Goods Sold
|
|
|
(418,693
|
)
|
|
|
(337,546
|
)
|
|
|
81,147
|
|
Gross Profit
|
|
|
1,424,216
|
|
|
|
1,058,651
|
|
|
|
365,565
|
|
Our long-term
relationships with our key manufacturing partners for Travelan, our flagship consumer product, have assisted us in reducing our
cost of goods sold margin by 1% in comparison to the 2017 financial year. These key manufacturing partners provide us with steady,
reliable product at a known price which from a strategic point of view provides us with certainty around the manufacturing margins.
As we expand our sales efforts in the U.S., we have been able to maintain economies of scale thereby maintaining our cost of goods
sold margins.
Expenses
|
|
For the fiscal year ended
June 30,
|
|
|
Increase/
|
|
|
|
2018
|
|
|
2017
|
|
|
(Decrease)
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
|
3,412,576
|
|
|
|
3,109,845
|
|
|
|
302,731
|
|
Research and development expenses
|
|
|
2,257,224
|
|
|
|
4,630,674
|
|
|
|
(2,373,450
|
)
|
Selling and marketing expenses
|
|
|
686,714
|
|
|
|
1,271,526
|
|
|
|
(584,812
|
)
|
Total expenses
|
|
|
6,356,514
|
|
|
|
9,012,045
|
|
|
|
(2,655,531
|
)
|
General and
administrative expenses. General and administrative expenses increased by A$302,731 from fiscal 2017 to fiscal 2018
primarily due to increases in employee expenses, insurance, legal and listing and share registry, being partially offset by a
decrease in share-based payments made to directors during fiscal 2018.
Research
and development expenses. Research and development expenses decreased by A$2,373,450 from fiscal 2017 to fiscal 2018, primarily
due to the significant completion in our Phase II NASH clinical trial announced to the market in November 2017.
Selling and marketing
expenses. Selling and marketing expenses decreased by A$584,812 from fiscal 2017 to fiscal 2018 as we decreased our promotional
efforts for Travelan, our existing flagship consumer product.
Loss
for the period. As a result of the foregoing, our loss for the period after income tax benefit decreased by A$3,793,225, or
56%, from A$6,804,154 in fiscal 2017 to A$3,010,929 in fiscal 2018.
Given
our, and our subsidiaries’, history of recent losses, we have not recognized a deferred tax asset with regard to unused tax
losses and other temporary differences, as it has not been determined whether we, or our subsidiaries, will generate sufficient
future taxable income against which we can utilized these unused tax losses and any uncalculated potential deferred tax assets,
together with any other temporary differences. Should the need arise, we can, and will, revisit this position.
Inflation and Seasonality
Management believes inflation
has not had a material impact on our company’s operations or financial condition and that our operations are not currently
subject to seasonal influences.
Conditions in Australia
We are incorporated under
the laws of, and our principal offices and research and development facilities are located in, the Commonwealth of Australia. Therefore,
we are directly affected by political and economic conditions in Australia. See Item 3.D. “Key Information – Risk Factors
– Risks Relating to Our Location in Australia” for a description of factors that could materially affect our operations.
Recently Issued International Accounting Standards
and Pronouncements
New and amended Accounting
Standards adopted by the Group
All accounting
policies adopted are consistent with the most recent Annual Financial Report for the year ended June 30, 2019. The
consolidated entity has adopted all of the new, revised or amended Accounting Standards and Interpretations issued by the
IASB that are mandatory for the current reporting period. The adoption of these Accounting Standards and Interpretations did
not have any significant impact on the financial performance or position of the consolidated entity.
The group has applied the
following standards and amendments for the first time for their annual reporting period commencing July 1, 2018:
|
●
|
IFRS 9 Financial Instruments
|
|
●
|
IFRS 15 Revenue from Contracts with Customers; and
|
|
●
|
IFRS 2 Amendments to Share-based Payment.
|
The group has changed its
accounting policies without making retrospective adjustments following the adoption of IFRS 9 and IFRS 15. This is disclosed in
note 1. Most of the other amendments listed above did not have any impact on the amounts recognized in prior periods and are not
expected to significantly affect the current or future periods.
New Accounting Standards
and Interpretations not yet adopted
Certain new
accounting standards and interpretations have been published that are not mandatory for June 30, 2019 reporting periods
and have not been early adopted by the group. The group’s assessment of the impact of these new standards and
interpretations is set out below.
Title of standard
|
|
IFRS 16 Leases
|
|
|
|
Impact
|
|
The group has reviewed all leasing
arrangements in light of the new lease accounting rules in IFRS 16. The standard will affect the accounting for the group’s
operating leases.
As at the reporting date, the group has non-cancellable operating
lease commitments of $104,851, see note 13.
The group expects to recognize right-of-use
assets of approximately $96,824 on July 1, 2019 and lease liabilities of $98,302 (after adjustments for prepayments and accrued
lease payments recognized as at June 30, 2019). Overall net assets will be approximately $1,479 lower, and net current assets will
be $56,913 lower due to the presentation of a portion of the liability as a current liability.
The group expects that net profit after tax will decrease by
approximately $1,532 for the year ended June 30, 2020 as a result of adopting the new rules.
Operating cash flows will increase and financing cash flows
decrease by approximately $41,389 as repayment of the principal portion of the lease liabilities will be classified as cash flows
from financing activities.
The group does not act in the capacity as a lessor and hence
the group does not expect any lessor impact on the financial statements.
|
|
|
|
Mandatory application date/ Date of adoption by group
|
|
The group will apply the standard from its mandatory adoption
date of July 1, 2019.
The group intends to apply the
modified retrospective transition approach and will not restate comparative amounts for the year prior to first adoption. Right-of-use
assets will be measured at the amount of the lease liability on adoption (adjusted for any prepaid or accrued lease expenses).
|
There
are no other new standards and interpretations that are not yet effective and that would be expected to have a material impact
on the group in the current or future reporting periods and on foreseeable future transactions.
B. Liquidity
and Capital Resources
We have incurred cumulative
losses and negative cash flows from operations since our inception in 1994 and as of June 30, 2019 we had accumulated losses of
A$56,860,523.
In May 2019, the Company
completed an underwritten public offering of 500,000 ADSs at a public offering price of USD $4.00 per ADS for gross proceeds $2,000,000
(prior to deducting underwriting discounts, commissions and other estimated offering expenses).
In June 2017, we sold 610,000
ADSs and Warrants to purchase 701,500 ADSs (not including the 35,075 Representative’s Warrants) in an initial public offering
in the U.S. The aggregate net offering proceeds to us, after deducting underwriting discounts and commissions, was US$5,673,000.
Additionally, in mid-March 2018, we completed a A$5,161,585 private placement with a large US institutional investment fund.
The funds will support current and future clinical programs, support continued Travelan marketing, and our working capital. We
anticipate that we will continue to incur losses for the foreseeable future. We expect that as we continue research efforts and
the development of our product candidates, hire additional staff, including clinical, scientific, operational, financial and management
personnel we will need additional capital to fund our operations which we may raise through a combination of equity offerings,
debt financings, other third-party funding and other collaborations, strategic alliances and licensing arrangements.
The commitment
to these projects will require additional external funding, at least until we are able to generate sufficient cash flow from sale
of one or more of our products to support our continued operations. If adequate funding is not available, we may be required to
delay, scale back or eliminate certain aspects of our operations or attempt to obtain funds through unfavorable arrangements with
partners or others that may force us to relinquish rights to certain of our technologies, products or potential markets or that
could impose onerous financial or other terms. Management is continuing its efforts to obtain additional funds so that we can meet
our obligations and sustain operations.
The sale of additional
equity or convertible debt could result in additional dilution to our shareholders. The incurrence of indebtedness would result
in debt service obligations and could result in operating and financing covenants that would restrict our operations. We can provide
no assurance that financing will be available in the amounts we need or on terms acceptable to us, if at all. If we are unable
to secure adequate additional funding we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate
assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm our business.
We do not currently have any credit facilities in
place.
As of June 30, 2019, we
had cash of A$5,119,887 as compared to cash of A$4,727,430 as of June 30, 2018. Additionally, during the current year we also
recognized a total of A$968,926 in receivables, including A$531,828 related to an R&D Tax Concession, which has not yet been
received. Management is satisfied that with receipt of the R&D Tax Concession refund for fiscal year 2019 R&D expenditures
and the anticipated increase in Travelan sales in both the Australian and U.S. markets, our company is a going concern and is of
the opinion that no asset is likely to be realized for an amount lower than the amount at which it is recorded in our Consolidated
Statement of Financial Position as of June 30, 2019.
We expect that our current
cash, cash equivalents will be sufficient to fund our capital requirements for at least 12 months from the issuance date of the
financial statements. Our future funding requirements will depend on many factors, including, but not limited to:
|
●
|
the timing and costs of our planned clinical trials
for our product candidates;
|
|
●
|
the timing and costs of our planned preclinical studies
for our product candidates;
|
|
●
|
the number and characteristics of product candidates
that we pursue;
|
|
●
|
the outcome, timing and costs of seeking regulatory
approvals;
|
|
●
|
revenue received from commercial sales of any of our
product candidates that may receive regulatory approval;
|
|
●
|
the terms and timing of any future collaborations,
licensing, consulting or other arrangements that we may establish;
|
|
●
|
the amount and timing of any payments we may be required
to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents
or other intellectual property rights;
|
|
●
|
the costs of preparing, filing and prosecuting patent
applications, maintaining and protecting our intellectual property rights and defending against intellectual property related
claims; and
|
|
●
|
the extent to which we need to in-license or acquire
other products and technologies.
|
In connection with our initial public offering in June
2017, we sold Warrants to purchase 701,500 ADSs at an initial exercise price of $10.00 per ADS. The Warrants will expire five
years from the date of issuance. Any proceeds from the exercise of the Warrants will be added to our working capital.
Upon the closing of our
initial public offering, we issued Warrants to purchase 35,075 ADSs to the representatives (the “Representative’s Warrants”).
The Representative’s Warrants are exercisable at a per ADS exercise price equal to $12.50. The Representative’s Warrants
are exercisable at any time and from time to time, in whole or in part, during the four-year period commencing one year from the
effective date of the offering. Any proceeds from the exercise of the Representative’s Warrants will be added to our working
capital.
Cash flows
The following table sets forth the primary sources
and uses of cash for each of the periods set forth below:
|
|
For the year ended June 30,
|
|
|
|
2019
|
|
|
2018
|
|
|
2017
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
Net cash used in operating activities
|
|
|
(1,798,579
|
)
|
|
|
(3,504,523
|
)
|
|
|
(6,942,423
|
)
|
Net cash (used in)/from investing activities
|
|
|
(2,008
|
)
|
|
|
(5,316
|
)
|
|
|
2,690
|
|
Net cash from financing activities
|
|
|
2,069,183
|
|
|
|
4,348,985
|
|
|
|
8,604,001
|
|
Operating activities.
During the twelve months ended June 30, 2018 and 2019, net cash used in operating activities decreased by A$1,705,944 from
A$3,504,523 to A$1,798,579, respectively. Net cash used in operating activities decreased by A$3,437,900 from A$6,942,423 in fiscal
year 2017 to A$3,504,523 in fiscal year 2018. The use of net cash in all periods resulted from our ordinary business operations.
Net cash used in operating activities decreased by approximately 50% in fiscal year 2018 and 2019 due to the completion of our
Phase II NASH clinical trial during the year which resulted in decrease in operational cash payments Another factor affecting the
decrease in net cash from operational activities was an increase in receipts from customers during the financial year 2018 and
2019.
Investing
activities. Net cash used in investing activities during the twelve months ended June 30, 2019, 2018 and 2017 were relatively
minimal and solely related to interest received and pertained to purchases of office and computer equipment.
Financing activities.
During the twelve months ended June 30, 2019, net cash provided by financing activities was A$2,069,183, which comprised
of proceeds from issue of securities through a public offering of ADSs (less costs associated with the issue).
During the twelve
months ended June 30, 2018, net cash provided by financing activities was A$4,348,985, which comprised of (i) proceeds from issue
of securities through a private placement (less costs associated with the issue), (ii) receipt of borrowings from short-term R&D
Tax Concession loan advances from a related party and (iii) repayments of borrowing principal of the convertible notes, interest,
other costs of finance paid and R&D Tax Concession loan advances.
During the twelve
months ended June 30, 2017, net cash provided by financing activities was A$8,604,001, which comprised of (i) proceeds from issue
of securities on the Australia Stock Exchange (less costs associated with the offer), (ii) proceeds from issue of securities as
part of our IPO and listing of our securities on The NASDAQ Capital Market (less costs associated with the offering), (iii) receipt
of borrowings from short-term R&D Tax Concession loan advances from a related party and (iv) repayments of borrowing principal
of the convertible notes, interest, other costs of finance paid and R&D Tax Concession loan advances.
Quantitative and qualitative disclosures about
market risks
We are exposed to
market risk related to changes in interest rates and exchange rates. As of June 30, 2019, we had cash and cash equivalents of A$5,119,887,
primarily held in bank accounts. Our primary exposure to market risk is interest rate sensitivity, which is affected primarily
by changes in the general level of Australian interest rates. We are exposed to interest rate risks relating to our cash and borrowings.
Interest rate risk is the risk that a financial instruments value will fluctuate as a result of changes in market interest rates.
We are exposed to
fluctuations in foreign currencies that arise from foreign currencies held in bank accounts and the translation of results from
our operations outside Australia. Our foreign exchange exposure is primarily to the U.S. dollar and Canadian dollar. Foreign currency
risks arising from commitments in foreign currencies are managed by holding cash in that currency. Foreign currency translation
risk is not hedged.
C. Research and Development,
Patents and Licenses
In recent years, we have
continued our practice of building valuable research collaborations with institutes based in Australia, the United States, the
United Kingdom and other countries to enable us to investigate a variety of therapeutic indications including Autism Spectrum Disorders,
IBD such as colitis, Campylobacter, Shigella and Uropathogenic E.coli Infections. These collaborative arrangements ensure that
we work with well-respected key opinion leaders and laboratories with specific expertise in screening and animal modelling of relevance
to the particular indication, without incurring ongoing administrative and personnel costs. We maintain in-house patent counsel
and research and development project expertise to coordinate these research collaborations.
When a lead compound is identified
as suitable for clinical development, we establish a project team to coordinate all non-clinical and clinical development and manufacturing
activities. Typically, we would project manage all the project activities, tasks and milestones and engage clinical research organizations
and contract manufacturing organizations to assist. We manage our manufacturing campaigns through contract manufacturing organizations
for quality assurance and cGMP compliance. All clinical, non-clinical, clinical development and manufacturing of our compounds
is performed in compliance with the appropriate governing authorities, regulators and standards (for example, the International
Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
Research and development
expenses amounted to A$4,630,674, A$2,257,224 and A$1,044,528 during the years ended June 30, 2017, 2018 and 2019, respectively.
Costs associated with patent applications and defense of patent applications are classified as research and development expenses
and amounted to approximately A$290,000, A$176,000 and A$142,000, during the years ended June 30, 2017, 2018 and 2019, respectively.
Our research
and development expenses consist primarily of expenses for contracted research and development activities conducted by third
parties on our behalf, including personnel, testing facilities and other payments in accordance with our research and
clinical agreements. Research and development expenses also include costs associated with the acquisition and development of
patents. Due to the numerous variables and the uncertain nature of the development of a clinical compound, including
obtaining regulatory approvals, we are not able to reasonably estimate the nature, timing and costs of the future
expenditures necessary to complete our research and development projects, the anticipated completion dates of each project
and when material net cash flows from our research and development programs will commence.
D. Trend Information
We are a clinical development
stage company and while we believe that our technology will offer novel therapeutic strategies into an expanding market, we cannot
predict with any degree of accuracy the outcome of our research or commercialization efforts. Accordingly, any trends within the
markets in which we operate are expected to have more direct impact on our business in the event that we are successful in commercializing
our new product candidates, including our current lead product candidates.
Over the past few years,
there has been increasing pressure to reduce drug prices in the developed markets as a consequence of political initiatives and
regulations aiming to curb continuous increases in healthcare spending. Any revenue we earn in the future may be negatively affected
by such political initiatives and regulations. The increased burden of healthcare costs in the aging population have led to an
increased focus on reducing costs and, therefore, have further increased the pressure to lower drug prices. We expect this trend
to continue in the years ahead. However, we believe spending in the healthcare industry, as compared to many other industries,
is less linked to economic trends. We expect sales growth to continue at higher levels in emerging markets and also for niche,
orphan indications. We also expect that demographic developments, increased treatment penetration, especially in newly established
drug markets, and better diagnostic tools to enable the tailoring of drugs to specific needs, will result in continuing growth
in overall global drug sales.
E. Off-Balance
Sheet Arrangements
We are not a party to any
material off-balance sheet arrangements. In addition, we have no unconsolidated special purpose financing or partnership entities
that are likely to create material contingent obligations.
F. Tabular
Disclosure of Contractual Obligations
The following table summarizes
our minimum contractual obligations as of June 30, 2019. We have the ability to scale down our operations and prioritize our research
and development programs to reduce expenditures as discussed in Item 5B. Liquidity and Capital Resources.
Contractual Obligations
|
|
Payments due by period
|
|
|
|
Total
|
|
|
less than
1 year
|
|
|
1-3 years
|
|
|
3-5 Years
|
|
|
more than
5 years
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
Operating lease obligations
|
|
|
104,851
|
|
|
|
41,389
|
|
|
|
63,462
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
104,851
|
|
|
|
41,389
|
|
|
|
63,462
|
|
|
|
—
|
|
|
|
—
|
|
G. Safe
Harbor
See “Introduction”
for disclosure regarding forward-looking statements.
ITEM 6. DIRECTORS, SENIOR
MANAGEMENT AND EMPLOYEES
A. Directors
and Senior Management
As of October 23, 2019, our directors and executive officers are as follows:
Name
|
|
Age
|
|
Position
|
Dr. Roger Aston
|
|
63
|
|
Non-Executive Chairman
|
Mr. Peter Anastasiou
|
|
59
|
|
Executive Vice Chairman
|
Mr. Daniel Pollock
|
|
59
|
|
Non-Executive Director
|
Mr. Stephen Anastasiou
|
|
62
|
|
Non-Executive Director
|
Prof. Ravi Savarirayan
|
|
52
|
|
Non-Executive Director
|
Dr.
Gary S. Jacob, Ph.D.
|
|
72
|
|
Chief Executive Officer and Non-Executive Director
|
Dr. Jerry Kanellos, Ph.D.
|
|
56
|
|
Chief Operating Officer
|
Mr. Phillip Hains
|
|
60
|
|
Chief Financial Officer and Secretary
|
Mr. Peter Anastasiou
and Mr. Stephen Anastasiou are brothers. Other than such relationship, there are no family relationships among our directors and
senior executives. Mr. Richard J. Berman resigned as our Non-Executive Director effective October 17, 2019.
Roger
Aston has been a member of our board of directors and
the board’s Independent Non-Executive Chairman since March 2012. He also has special responsibilities as a member of
the audit and risk committee and chair of the remuneration committee. Dr. Aston holds a BSc (Hons) and PhD. He has more than 20
years’ experience in the pharmaceutical and biotechnology industries. Dr Aston was previously the chief executive officer
and a director of Mayne Pharma Group Limited (ASX: MYX). Prior to his position at Mayne Pharma, some of his previous positions
have included chief executive officer of Peptech Limited (ASX: PTD), director of Cambridge Antibody Technology Limited (LSE: CAT
and NASDAQ: CATG) and chairman of Bio Focus Plc (formerly: Cambridge Drug Discovery Limited). Dr Aston was also founder and chief
executive officer of Biokine Technology Ltd (UK) prior to its acquisition by the Peptech Group. Dr Aston was also a director of
pSivida Ltd. During the past 20 years of his career, Dr Aston has been closely involved in the development of many successful
pharmaceutical and biotechnology companies. He has extensive experience including negotiating global license agreements, overseeing
product registration activities with the FDA, the establishment and implementation of guidelines and operating procedures for
manufacturing and clinical trials, overseeing manufacturing of human and veterinary products, private and public fund-raising
activities and the introduction of corporate governance procedures. Dr. Aston’s other current directorships are with Oncosil
Limited (ASX: OSL) since March 2013, Pharmaust Limited (ASX: PAA) since August 2013, and Resapp Health Limited (ASX: RAP)
since July 2015. He held the position of director and chairman of Regeneus Limited (ASX:RGS) until April 2019.
Peter Anastasiou has
been a member of our board of directors and our Executive Vice Chairman since May 2015. Mr. Anastasiou holds a B.Psych and is a
serial entrepreneur and investor with extensive experience in business in Australia and internationally. Over the past 25 years,
he has been credited with rebuilding a number of companies through the implementation of various corporate restructurings, acquisitions
and solid financial management practices, with his most recent success being managing the restructuring of SABCO to ensure the
future of this 100-year-old iconic Australian company. Mr. Anastasiou’s involvement with Immuron commenced in May 2013 following
his substantial underwriting support of the group’s renounceable rights issue, which was surpassed by his further funding
support of the A$9.66 million (before costs) capital raising in February 2014 resulting in an ownership of approximately 15 percent
of the company via his associated investment funds. Mr. Anastasiou was the founding chairman of the ACSI Group of Companies, which
has owned and managed successful consumer companies such as SABCO, Britex Carpet Care, Rug Doctor and Crystal Clear. Mr. Anastasiou
also has a number of philanthropic interests including being a patron of the Identity Theatre for men, a prior board member and
supporter of the Indigenous Eye Health Unit at Melbourne University, a supporter of the John Fawcett Foundation in Bali, and a
founding investor and director of Melbourne Victory Football Club.
Gary S. Jacob, Ph.D. has
served as our Chief Executive Officer since November 2018 and a director since April 2019. Dr. Jacob earned a Bachelor of Science
cum laude in Chemistry from the University of Missouri-St. Louis, and holds a PhD in Biochemistry from the University of Wisconsin-Madison.
Dr. Jacob’s more than 30 years of experience in the pharmaceutical and biotechnology industries covers multiple disciplines,
including research and development, operations, business development, capital financing activities and senior management expertise.
He is the co-founder and founding chief executive officer of Synergy Pharmaceuticals Inc. where he also served as chairman and
is the co-inventor of the FDA-approved drug Trulance for treating functional gastrointestinal disorders. In December 2018, Synergy
Pharmaceuticals Inc. filed a petition for relief under Chapter 11 of the U.S. Bankruptcy Code. From May 2003 until January 2013,
Dr. Jacob served as chief executive officer and a director of Callisto Pharmaceuticals, Inc. (AMEX: KAL) a publicly listed biotechnology
company focused on drugs to treat cancer. Prior to Callisto, Dr. Jacob was at Monsanto/G.D. Searle, where he served as Director
of Glycobiology and Monsanto Science Fellow, specializing in the fields of glycobiology and drug discovery. From 1986 to 1990,
Dr. Jacob, while located at Oxford University, England, managed the G.D. Searle Glycobiology Group. Dr. Jacob has over 50 peer-reviewed
publications in scientific journals, over 15 issued US patents and is the co-inventor of two pharmaceutical drugs, one of which
is FDA approved. He is the recipient of an honorary Doctor of Science degree from the University of Missouri-St. Louis, and has
been honored as a Distinguished Alumnus of the University. Dr. Jacob’s other current directorships are with Hepion Pharmaceuticals
Inc, (NASDAQ: HEPA) since May 2013 and Trovagene, Inc. (NASDAQ: TROV) since 2009.
Daniel Pollock has
been a member of our board of directors and our Independent Non-Executive Director since October 2012. He also has special responsibilities
as chair of the audit and risk committee and a member of the remuneration committee. Mr. Pollock holds a Bachelor of Laws and Diploma
in Professional Legal Practice and is a lawyer admitted in both Scotland and Australia and holding practicing certificates in both
jurisdictions. He is a sole practitioner in his own legal firm based in Melbourne which operates internationally and specializes
in commercial law. Further, he is executive director and co-owner of Great Accommodation Pty Ltd, a property management business
operating in Victoria. Mr. Pollock has had historical involvement as a seed investor and board member of a number of small unlisted
companies. The most recent of these was an e-pharmacy company where he was heavily involved in its commercial growth and ultimate
sale to a large listed health services company.
Stephen Anastasiou has
been a member of our board of directors and our Independent Non-Executive Director since May 2013. Mr. Anastasiou holds a Bachelor
of Science (Hons), Graduate Diploma in Marketing and Master of Business Administration. He has over 20 years of experience in general
management, marketing and strategic planning within the healthcare industry. His breadth of experience incorporates medical diagnostics,
pharmaceuticals, hospital, dental and over-the-counter products, with companies including the international pharmaceutical company
Bristol-Myers Squibb (NYSE: BMY). While working with KPMG Peat Marwick as a management consultant, Mr. Anastasiou previously led
project teams in a diverse range of market development and strategic planning projects in both the public and private sector. He
is also a director and shareholder of a number of unlisted private companies, covering a variety of industry sectors that include
healthcare and funds management. Mr. Anastasiou’s companies have participated in several corporate transactions involving
business units and brands of multinational and Australian companies.
Professor Ravi
Savarirayan has been a member of our board of directors and our Independent Non-Executive Director since April
2017. Prof. Savarirayan holds a Doctor of Medicine from the University of Melbourne, a Bachelor of Medicine and Bachelor of Surgery
from the University of Adelaide, is a Fellow of the Royal Australasian College of Physicians (FRACP) and is a member of the American
Academy of Physician Assistants (ARC-PA, Hons). He has been a consultant clinical geneticist at the Victorian Clinical Genetics
Services since August 1999, as well as professor and research group leader of skeletal biology and disease at the Murdoch Children’s
Research Institute since September 2000. Prof. Savarirayan has served as a founding member of the Skeletal Dysplasia Management Consortium
since January 2011 and has acted as the chair of the specialist advisory committee in clinical genetics at the Royal Australasian
College of Physicians since February 2009. He was president of the International Skeletal Dysplasia Society from July 2009 to
June 2011 and has been an invited member of several international working committees on constitutional diseases of bone. Prof.
Savarirayan’s primary research focus is on inherited disorders of the skeleton causing short stature, arthritis and osteoporosis.
He has published over 150 peer-reviewed articles, collaborating with peers from over 30 countries. He has been on the editorial
board of Human Mutation since January 2009, European Journal of Human Genetics since July 2007, American Journal of Medical Genetics
since December 2011 and the Journal of Medical Genetics since June 2005.
Dr. Jerry Kanellos,
Ph.D. has been our Chief Operating Officer since July 2015, and served as our Interim CEO from August 2017 until November
2018 and our Chief Scientific Officer from July 2015 to November 2018. In addition, since April 2018, Dr. Kanellos has served as
a director of IMC Canada Limited. Dr. Kanellos has over 25 years of experience in the pharmaceutical and biotechnology
industry, and has held leadership roles in executive management, business development, project management, intellectual property
portfolio management research and development. From 2008 until 2012, Dr. Kanellos was the Chief Operating Officer of TransBio Limited
where he was responsible for the strategic identification, development and maintenance of commercial partnerships globally, along
with development, management and maintenance responsibility for the intellectual property portfolio, research and development and
technology transfer. Prior to this, Dr. Kanellos worked for five years as a consultant to the biotechnology industry and provided
development and commercialization strategies for various bodies including academic institutes, private and publicly listed companies
and government departments both national and international. He has also been involved in the establishment and management of several
startup biotechnology companies. During his ten year tenure in research and development at CSL Limited, a global specialty biotherapeutics
company that develops and delivers innovative biotherapies, Dr. Kanellos gained considerable experience in the international drug
development process, formulation development through to pharmaceutical scale up and cGMP manufacture successfully leading the Chemistry
Manufacturing and Controls programs for the approval, manufacture and launch of several products. Dr. Kanellos holds a PhD
degree in Medicine from the University of Melbourne.
Company secretary
Mr. Phillip
Hains was appointed as the secretary of the Company in April 2013. Mr. Hains is a Chartered Accountant operating a specialist
public practice, ‘The CFO Solution’. The CFO Solution focuses on providing back office support, financial reporting
and compliance systems for listed public companies. A specialist in the public company environment, Mr. Hains has served the needs
of a number of company boards and their related committees. He has over 30 years of experience in providing businesses with accounting,
administration, compliance and general management services. He holds a Master of Business Administration from RMIT University and
a Public Practice Certificate from the Chartered Accountants Australia and New Zealand.
B. Compensation
Our remuneration policy is
designed to ensure that directors and senior management are appropriately remunerated having regard to their relevant experience,
their performance, the performance of our company, industry norms and standards and the general pay environment as appropriate.
Our remuneration policy has been established to enable us to attract, motivate and retain suitably qualified directors and senior
management who will create value for shareholders.
Our remuneration policy is
not directly based on our earnings. Our earnings have remained negative since inception due to the nature of our company. Shareholder
wealth reflects this speculative and volatile market sector. No dividends have ever been declared by us. We continue to focus on
the research and development of our intellectual property portfolio with the objective of achieving key development and commercial
milestones in order to add further shareholder value.
Non-Executive Director Remuneration
Similarly, our remuneration
policy is designed to ensure that non-executive directors are appropriately remunerated with respect to their relevant experience,
individual performance, the performance of our company, industry norms/standards and the general pay environment as appropriate.
Our Constitution and the
ASX Listing Rules specify that the aggregate remuneration of non-executive directors shall be determined from time to time by a
meeting of shareholders. An amount (not exceeding the amount approved at the shareholders’ meeting) is determined by the
Board and then divided between the non-executive directors. The latest determination was at the shareholders’ meeting held
on November 19, 2018 when shareholders approved the aggregate maximum cash sum to be paid or provided as remuneration to the directors
as a whole (other than the managing director and executive directors) for their services as A$500,000 per annum. This compensation
is cash based and does not include stock based compensation.
In the year ended June 30,
2019, our Non-Executive directors received an aggregate of A$378,423, including superannuation and our executive directors received
A$361,195. The manner in which the aggregate remuneration is apportioned among non-executive directors is reviewed periodically.
The Board is responsible for reviewing its own performance. Both Board and Board committee performance is monitored on an informal
basis throughout the year with a formal review conducted during the financial year. No retirement benefits are payable other than
statutory superannuation, if applicable.
Executive Director and Executive Officer Remuneration
Our remuneration policy
is also designed to ensure that executive directors are appropriately remunerated with respect to their relevant experience, individual
performance, the performance of our company, industry norms/standards and the general pay environment as appropriate.
Our non-executive directors
are responsible for evaluating the performance of the Chief Executive Officer (“CEO”) who in turn evaluates the performance
of the other senior executives. The evaluation process is intended to assess our business performance, whether long-term strategic
objectives are being achieved, and the achievement of individual performance objectives.
The performance of our
CEO and senior executives are monitored on an informal basis throughout the year and a formal evaluation is performed annually.
Fixed Remuneration.
Executives’ fixed remuneration comprises salary and superannuation and is reviewed annually by the CEO, and in turn,
the Remuneration Committee. This review takes into account the executives’ experience, performance in achieving agreed objectives
and market factors as appropriate.
Variable Remuneration
- Short Term Incentive Scheme. Executives may be entitled to receive a combination of short term incentives (“STI”)
and long term incentives (“LTI”) as part of their total remuneration if they achieve certain performance indicators
as set by the Board. These STI /LTI may be paid either by cash, or a combination of cash and the issue of equity in our company,
at the determination of the Board and Remuneration Committee.
The Remuneration Committee
approves the issuance of bonuses following the recommendations of the CEO in the annual review of the performance of the executives,
and our company as a whole, against agreed key performance indicators (“KPIs”).
Variable Remuneration
- Long Term Incentive Scheme. Executives may also be provided with longer-term incentives through our Employee Share and Option
Plan (“ESOP”) that was approved by shareholders at our annual general meeting held on November 13, 2014. The goal of
the ESOP is to allow the executives to participate in, and benefit from, the growth of our company as a result of their efforts
and to assist in motivating and retaining those key employees over the long term. Continued service is the condition attached to
the vesting of the options. The Board at its discretion determines the total number of options granted to each executive.
Remuneration paid in Fiscal 2019
The following table sets
forth all compensation we paid for the year ended June 30, 2019 with respect to each of our executive officers and directors during
the 2019 fiscal year:
2019
|
|
Short-term benefits
|
|
|
Post-
employment
benefits
|
|
|
Long-
term
benefits
|
|
Share-
based
payments
|
|
|
|
|
|
Cash
salary and fees
|
|
|
Other
|
|
|
Super-
annuation
|
|
|
Long
service
leave
|
|
Options
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
$
|
|
$
|
|
Non-executive directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Roger Aston
|
|
|
70,000
|
|
|
|
-
|
|
|
|
6,650
|
|
|
|
-
|
|
|
-
|
|
|
76,650
|
|
Mr. Daniel Pollock
|
|
|
60,000
|
|
|
|
-
|
|
|
|
5,700
|
|
|
|
-
|
|
|
-
|
|
|
65,700
|
|
Mr. Stephen Anastasiou
|
|
|
50,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
-
|
|
|
50,000
|
|
Prof. Ravi Savarirayan
|
|
|
50,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
-
|
|
|
50,000
|
|
Mr. Richard Berman (1)
|
|
|
136,073
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
164,400
|
|
|
300,473
|
|
Executive directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. Peter Anastasiou
|
|
|
50,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
-
|
|
|
50,000
|
|
Dr. Gary Jacob (2)
|
|
|
311,195
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
975,000
|
|
|
1,286,195
|
|
Other KMP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Jerry Kanellos (3)
|
|
|
210,000
|
|
|
|
15,138
|
|
|
|
19,950
|
|
|
|
3,652
|
|
|
157,000
|
|
|
405,740
|
|
Total KMP compensation
|
|
|
937,268
|
|
|
|
15,138
|
|
|
|
32,300
|
|
|
|
3,652
|
|
|
1,296,400
|
|
|
2,284,758
|
|
|
1.
|
Resigned as a member of the Company’s board of directors effective as of October 17, 2019.
|
|
2.
|
Appointed as Chief Executive Officer on November 19, 2018 and an Executive director on April 17, 2019.
|
|
3.
|
Served as Interim CEO until November 19, 2018.
|
Employment Agreements with Executive Officers
We have contracts with all of our senior management
and employees, and letters of appointment for each of our directors.
Gary S. Jacob
On February
11, 2019 (the “Effective Date”), we entered into an Executive Employment Agreement (the “Jacob Agreement”)
with Gary S. Jacob pursuant to which Mr. Jacob serves as our Chief Executive Officer. The term of the Jacob Agreement is for a
period of three years from the Effective Date, which term shall be automatically renewed for successive one year periods until
either Mr. Jacob or the Company provides written notice of their intent to not renew such term at least 60 days prior to the expiration
of the term. Pursuant to the Jacob Agreement, Mr. Jacob shall receive a base salary of US$350,000, which may be increased by the
Company’s Board. In addition, Mr. Jacob shall be eligible to receive for each fiscal year beginning on July 1, 2019 and for
the pro-rated portion of the fiscal year ended June 30, 2019, an annual cash bonus of up to 50% of his then base salary subject
to the achievement of certain Company and individual performance goals as established by the Board or a committee thereof. The
Company also granted Mr. Jacob a five-year option (the “Option Termination Date”) to purchase up to 5,000,0000 ordinary
shares at an exercise price of $A0.50 per share which option will expire upon the earlier of the Option Termination Date or Mr.
Jacob’s resignation without Good Reason (as defined in the Jacob Agreement) or termination for Cause (as defined in the Jacob
Agreement).
If the Jacob
Agreement expires as a result of the Company’s election to not renew the employment term or Mr. Jacob is terminated by the
Company other than for Cause or as a result of Mr. Jacob’s death or permanent disability or by Mr. Jacob for Good Reason,
Mr. Jacob shall receive (i) his accrued by unpaid base salary through the termination date, (ii) reimbursement of unreimbursed
business expenses incurred prior to the termination date, (iii) other vested rights and benefits (including with respect to Mr.
Jacob’s equity interests in the Company) and (iv) the annual bonus, if any, for the year ending immediately prior to the
year in which the termination date occurs (collectively, the “Accrued Obligations”). Furthermore, if Mr. Jacob executes
a general release of all claims against the Company and such release becomes effective within 60 days following the date of Mr.
Jacob’s termination, Mr. Jacob shall receive the following: (i) continuation of Mr. Jacob’s then base salary during
the Severance Period (as defined in the Jacob Agreement) and (ii) a pro-rated target bonus. In the event the Company terminates
Mr. Jacob’s employment for Cause or failure in the first year of the Jacob Agreement to meet a material part of the Company’s
corporate goals as determined by the Company or by Mr. Jacob other than for Good Reason or as a result of Mr. Jacob’s permanent
disability or death or in connection with the Company’s notice of its intent not to renew the employment term, Mr. Jacob
shall be entitled to receive the Accrued Obligations.
Jerry Kanellos
On July 23, 2015, we entered
into an Executive Service Agreement with Dr. Jerry Kanellos (the “Kanellos Agreement”), pursuant to which Dr. Kanellos
is serving as our Chief Operating & Scientific Officer. Pursuant to the Kanellos Agreement, we will pay Dr. Kanellos A$160,000
per annum. Following Dr. Kanellos’ appointment as Interim-Chief Executive Officer on August 3, 2017, we increased his base
salary to A$210,000 per annum plus 9.5% Australia superannuation guarantee equating to a total remuneration package of A$229,950
per annum. On November 19, 2018, Dr. Jerry Kanellos resigned as Interim CEO and moved to the role of Chief Operating Officer on
the same date with no change in remuneration.
Our Board has approved
the issuance of 200,000 options to Dr. Kanellos under our existing ESOP. Our Board will consider a short and long term share and/or
share option incentive package for Dr. Kanellos after twelve months of continuous employment, subject to any applicable shareholder
approval. We or Dr. Kanellos may terminate the Kanellos Agreement without cause on thirty days’ written notice. Subject
to applicable laws and rules, we may elect to pay Dr. Kanellos thirty days’ base salary instead of providing notice. We
may also terminate the Kanellos Agreement for Cause (as defined in the Kanellos Agreement).
Employee Share Option Plan
Under the term of the ESOP
the Board may offer options to key management staff and consultants and in special circumstances may provide financial assistance
to an entitled option holder to assist in the exercise of the ESOP options. The aggregate number of shares that may be issued upon
the exercise of the ESOP options, together with all other share purchase plans for eligible persons, may not at any time exceed
5% of the total number of our outstanding ordinary shares.
The assessed fair value
of options granted to personnel at their grant date is allocated equally over the period from grant date to vesting date, and the
amount for the 2019 financial year is included in the remuneration table as set out above. Fair values at grant date are determined
using the Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of
dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and
the risk-free interest rate for the term of the option. The expected price volatility is based on the historic volatility (based
on the remaining life of the options), adjusted for any expected changes to future volatility due to publicly available information.
As of June 30, 2019 the
number of options over ordinary shares in our company held by each director and other key management personnel of our company,
including their personally related parties, are set out below.
As of June 30, 2019
our executive officers and directors as a group, then consisting of nine persons, held options under our ESOP to purchase an aggregate
of 15,625,532 ordinary shares at an exercise price of A$0.50 per share. Of such options, options to purchase 7,625,532 ordinary
shares expire on November 27, 2019, options to purchase 1,000,000 ordinary shares expire on July 1, 2021, options to purchase 2,000,000
ordinary shares expire on June 30, 2020 and options to purchase 5,000,000 ordinary shares (to be granted subject to shareholder
approval) expire on February 10, 2024.
C. Board
Practices
As of June 30, 2019, our board
of directors consisted of seven members. Directors are elected at each annual general meeting of our shareholders and serve until
their successors are elected or appointed unless their office is earlier vacated. We believe that each of our directors has relevant
industry experience. The membership of our board of directors is directed by the following requirements:
|
●
|
our Constitution specifies that there must be a minimum
of three directors and a maximum of ten directors, and our board of directors may determine the number of directors within those
limits;
|
|
●
|
as set forth in our Board Charter, the membership
of the board of directors should consist of a majority of independent directors who satisfy the criteria recommended by the ASX
Corporate Governance Principles and Recommendations of the Australian Securities and Investments Commission (“ASIC”);
|
|
●
|
the Chairman of our Board should be an independent
director who satisfies the criteria for independence recommended by the ASX Corporate Governance Principles and Recommendations;
and
|
|
●
|
our board of directors should, collectively, have
the appropriate level of personal qualities, skills, experience, and time commitment to properly fulfill its responsibilities
or have ready access to such skills where they are not available.
|
Our board of directors has
delegated responsibility for the conduct of our businesses to the Chief Executive Officer, but remains responsible for overseeing
the performance of management. Our board of directors has established delegated limits of authority, which define the matters that
are delegated to management and those that require board of directors’ approval. Under the Corporations Act, at least two
of our directors must be resident Australians. None of our directors have any service contracts with us that provide for benefits
upon termination of employment.
We have not entered into
any service contracts with our directors providing for benefits upon termination of employment.
Committees
To assist our board of directors
with the effective discharge of its duties, it has established a Remuneration and Nomination Committee and an Audit and Risk Committee,
which committees operate under a specific charter approved by our board of directors.
Remuneration and Nomination Committee
The members
of our Remuneration and Nomination Committee are Roger Aston and Daniel Pollock, each of whom our board of directors has determined
meets the criteria for independence under NASDAQ Listing Rule 5605(a)(2). Dr. Aston acts as chairman of the committee. The committee’s
role involves:
|
●
|
identifying, evaluating and recommending qualified
nominees to serve on our board of directors;
|
|
●
|
evaluating, adopting and administering our compensation
plans and similar programs advisable for us, as well as modifying or terminating existing plans and programs;
|
|
●
|
establishing policies with respect to equity compensation
arrangements; and
|
|
●
|
overseeing, reviewing and reporting on various remuneration
matters to our board of directors.
|
Audit and Risk Committee
The members of our Audit and
Risk Committee are Daniel Pollock and Roger Aston, each of whom our board of directors has determined meets the criteria for independence
of audit committee members set forth in Rule 10A-3(b)(1) under the Securities Exchange Act of 1934, as amended, or the Exchange
Act, and the applicable rules of the NASDAQ Capital Market. Each member of our audit committee meets the financial literacy requirements
of the listing standards of the NASDAQ Capital Market. Daniel Pollock acts as the chairman of the audit committee. The principal
duties and responsibilities of our audit committee include, among other things:
|
●
|
overseeing and reporting on various auditing and accounting
matters to our board of directors, including the selection of our independent accountants, the scope of our annual audits, fees
to be paid to the independent accountants, the performance of our independent accountants and our accounting practices;
|
|
●
|
overseeing and reporting on various risk management
matters to our board of directors;
|
|
●
|
considering and approving or disapproving all related-party
transactions;
|
|
●
|
reviewing our annual and semi-annual financial statements
and reports and discussing the statements and reports with our independent registered public accounting firm and management;
|
|
●
|
reviewing and pre-approving the engagement of our
independent registered public accounting firm to perform audit services and any permissible non-audit services;
|
|
●
|
evaluating the performance of our independent registered
public accounting firm and deciding whether to retain their services; and
|
|
●
|
establishing procedures for the receipt, retention
and treatment of complaints received by us regarding financial controls, accounting or auditing matters.
|
D. Employees
As of June 30, 2019, we
had six full-time employees. Of these full-time employees, one is engaged in research and development activities, two are employed in manufacturing and quality control positions, one is employed in U.S. sales, one is our COO and one is our CEO.
Our employees are located in Australia, Israel and
the U.S.
E. Share
Ownership
Beneficial Ownership of Executive Officers and
Directors
The following table
sets forth certain information as of October 23, 2019 regarding the beneficial ownership of our ordinary shares by each of our
directors and executive officers and by all of our directors and executive officers as a group.
Unless otherwise indicated,
to our knowledge each shareholder possesses sole voting and investment power over the ordinary shares listed subject to community
property laws, where applicable. None of our shareholders have different voting rights from other shareholders.
Name
|
|
Number of Ordinary Shares Beneficially
Owned (1)
|
|
|
Percentage of
Ownership (2)
|
|
Dr. Roger Aston(3)
|
|
|
4,034,066
|
|
|
|
2.24
|
%
|
Mr. Peter Anastasiou(4)
|
|
|
22,994,573
|
|
|
|
12.64
|
%
|
Mr. Daniel Pollock(5)
|
|
|
1,654,600
|
|
|
|
*
|
|
Mr. Stephen Anastasiou(6)
|
|
|
9,498,154
|
|
|
|
5.28
|
%
|
Prof. Ravi Savarirayan(7)
|
|
|
1,000,000
|
|
|
|
*
|
|
Dr. Jerry Kanellos (PhD)(8)
|
|
|
1,200,000
|
|
|
|
*
|
|
Mr. Phillip Hains(9)
|
|
|
1,242,336
|
|
|
|
*
|
|
Dr. Gary S. Jacob(10)
|
|
|
5,260,000
|
|
|
|
2.89
|
%
|
Officers and directors as a group (9 persons)(11)
|
|
|
46,883,729
|
|
|
|
23.77
|
%
|
|
(1)
|
Beneficial ownership is determined in accordance with the
rules of the SEC and generally includes voting or investment power with respect to securities. Ordinary shares relating to options
currently exercisable or exercisable within 60 days of the date of this table are deemed outstanding for computing the percentage
of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Except
as indicated by footnote, and subject to community property laws where applicable, the persons named in the table above have sole
voting and investment power with respect to all shares shown as beneficially owned by them. Except as set forth herein, the address
for each of the persons listed in the table above is Immuron Limited, Level 3, 62 Lygon Street, Carlton South, Victoria, Australia
3053.
|
|
(2)
|
The percentages shown are based on 176,780,906 ordinary shares outstanding as of October 23, 2019, but do not include (i) 25,289,894 ordinary shares issuable upon the exercise of currently exercisable options that are traded on the ASX and (ii) 27,760,000 ordinary shares issuable upon exercise of outstanding warrants. The options, which were issued in an offering in Australia, have an exercise price of A$0.55 per share and expire on November 30, 2019. Certain warrants have an exercise price of US$10.00 per ADS while other warrants have an exercise price of US$12.50 per ADS.
|
|
(3)
|
Includes options and warrants to purchase 3,282,950 ordinary
shares.
|
|
(4)
|
Includes options and warrants to purchase 5,158,409 ordinary
shares. Peter Anastasiou is the Chairman of Grandlodge Capital Pty Ltd (“Grandlodge”) and in such capacity has voting
and dispositive power over the securities held by Grandlodge.
|
|
(5)
|
Includes options and warrants to purchase 1,134,800 ordinary
shares.
|
|
(6)
|
Includes options and warrants to purchase 3,247,017 ordinary
shares.
|
|
(7)
|
Includes 1,000,000 options to purchase ordinary shares.
|
|
(8)
|
Includes options to purchase 1,200,000 ordinary shares.
|
|
(9)
|
Includes options to purchase 425,532 ordinary shares.
|
|
(10)
|
Includes options to purchase 5,000,000 ordinary shares.
|
|
(11)
|
Includes options to purchase 20,448,708 ordinary shares.
|
ITEM
7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major
Shareholders
The following table
sets forth as of October 23, 2019 certain information regarding the beneficial ownership by all shareholders known to us to own
beneficially 5% or more of our ordinary shares:
|
|
Ordinary Shares
Beneficially Owned (1)
|
|
Shareholder
|
|
Number
|
|
|
Percent (2)
|
|
HSBC Custody Nom Aust. Ltd
|
|
|
29,304,544
|
|
|
|
16.58
|
%
|
Grandlodge Capital Pty Ltd(3)
|
|
|
16,430,163
|
|
|
|
9.03
|
%
|
|
(1)
|
Beneficial ownership is determined in accordance with the
rules of the SEC and generally includes voting or investment power with respect to securities. Ordinary shares relating to options
currently exercisable or exercisable within 60 days of the date of this table are deemed outstanding for computing the percentage
of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Except
as indicated by footnote, and subject to community property laws where applicable, the persons named in the table above have sole
voting and investment power with respect to all shares shown as beneficially owned by them.
|
|
(2)
|
The percentages shown are based on 176,780,906 ordinary shares outstanding as of October 23, 2019, but do not include (i) 25,289,894 ordinary shares issuable upon the exercise of currently exercisable options that are traded on the ASX and (ii) 27,760,000 ordinary shares issuable upon exercise of outstanding warrants.
|
|
(3)
|
Includes options and warrants to purchase 5,158,409 ordinary
shares. Peter Anastasiou is the majority owner of Grandlodge.
|
Significant Changes in the Ownership of Major
Shareholders
Previous substantial shareholders
Citicorp Nominees Pty Limited and Authentics Australia Pty Ltd ceased to be major shareholders following the issuance of securities
pursuant to our public offering in May 2019 and July 2019 as their existing shareholdings were diluted below 5% ownership.
Major Shareholders Voting Rights
All of our shareholders, including the shareholders listed below,
have the same voting rights attached to their ordinary shares.
Record Holders
As of October
23, 2019, there were 2,045 Immuron shareholders holding 176,780,906 fully paid ordinary shares. These numbers are not
representative of the number of beneficial holders of our shares nor are they representative of where such beneficial holders
reside, since many of these ordinary shares were held of record by brokers or other nominees. The majority of trading by our
U.S. investors is done by means of ADS that are held of record by HSBC Nominees Ltd., which held 37,930,184 (21.46%) of our
ordinary shares as of such date.
B. Related
Party Transactions
Grandlodge Capital Pty Ltd is an entity part-owned
and operated by our non-executive directors Peter Anastasiou and Stephen Anastasiou. Mr. David Plush is also an owner of Grandlodge,
and its associated entities.
On June 6, 2016 and
May 9, 2017, we executed short-term funding agreements with Grandlodge for a principal amount of A$750,000 (interest rate of 15%)
and A$500,000 (interest rate of 15%), respectively. The short- term funding was a cash advance against the anticipated refund
receivable from the Australian Taxation Office under the Research and Development Income Tax Concession Incentive for our eligible
R&D expenditure incurred for the financial years of 2016 and 2017. The loans from June 2016 and May 2017, plus applicable
fees and interest, were repaid to Grandlodge on December 2, 2016 and June 23, 2017, respectively. Interest expense was approximately
A$57,000 for the year ended June 30, 2017.
Starting June 1, 2013, Grandlodge
provides warehousing, distribution and invoicing services for our products for A$70,000 per year. During the 2019 financial year, the fees of A$70,000 equivalent were repaid by issuance of 437,500 ordinary
shares based on a price of A$0.16 per share representing the share price of our ordinary shares at the commencement date of
an oral agreement between us and Grandlodge. During the 2018 financial year, the fees of A$140,000 equivalent were repaid by issuance of 875,000 ordinary shares based on a set price of A$0.16 per share
representing the share price of our ordinary shares at the commencement date of an oral agreement between us and Grandlodge. The
875,000 shares issued to Grandlodge were in relation to the 2017 and 2018 financial years.
Grandlodge
is reimbursed in cash for all reasonable costs and expenses incurred in accordance with their scope of works under the oral agreement,
unless both Grandlodge and we agree to an alternative method of payment. The oral agreement may be terminated by either party upon
providing the other party with 30 days written notice of the termination of the agreement.
Effective January 2016,
we executed a Lease Agreement with Wattle Laboratories Pty Ltd, (“Wattle”), an entity part-owned and operated by our
non-executive directors, Peter Anastasiou and Stephen Anastasiou, whereby we lease part of their Blackburn office facilities for
our operations at a rental rate of A$38,940 per year, payable in monthly installments. The rental agreement is subject to annual
rental increases, and effective January 2017, the annual rent was increased to A$39,525. The lease is for a three year term with
an additional three year option period. The lease may be terminated by either party upon six months’ written notice. During
the fiscal years ended June 30, 2017, 2018 and 2019, we paid Wattle A$35,792, A$30,019 and A$53,958 (excluding Goods and Services
Tax), respectively. The lease was renewed, commencing January 1, 2019 for three years.
Grandlodge purchased US$1,500,000
on behalf of our company at the cost of A$1,968,762 on August 25, 2016 and on the same day we paid Grandlodge A$1,968,762 to settle
this transaction. On September 12, 2016, Grandlodge returned the US$1,500,000 they purchased on our behalf to us. Grandlodge received
no financial gains or benefits for this transaction.
On
July 7, 2016, we issued 18,045,512 ordinary shares in relation to the $4,511,378 received in a capital raising transaction that
we were committed to issue as of June 30, 2016. Of such shares, 2,418,129 shares and options were issued to Grandlodge on the same
terms and conditions as all other subscribers. In addition, Grandlodge participated in our June 2017 initial public offering in
the U.S. and acquired 32,707 ADSs and 32,707 warrants.
During the year
ended June 30, 2018, the group entered into a short-term loan arrangement for an amount of $500,000 with Great Accommodation
Pty Ltd, an entity controlled by Mr Daniel Pollock. The purpose of this loan was to fund on going R&D expenditure.
Interest accrued at a rate of 15% per annum in addition to a $15,000 establishment fee. The loan was repaid in full on
February 12, 2018.
C. Interests
of Experts and Counsel
Not applicable.
ITEM
8. FINANCIAL INFORMATION
A. Financial
Statements and Other Financial Information
See our consolidated financial statements, including
the notes thereto, included in Item 18.
Legal Proceedings
We are not involved in
any legal proceedings nor are we subject to any threatened litigation that is material to our business or financial condition.
Dividend Distribution Policy
We have never paid cash dividends
to our shareholders. We intend to retain future earnings for use in our business and do not anticipate paying cash dividends on
our ordinary shares in the foreseeable future. Any future dividend policy will be determined by the Board of Directors and will
be based upon various factors, including our results of operations, financial condition, current and anticipated cash needs, future
prospects, contractual restrictions and other factors as the Board of Directors may deem relevant.
B. Significant
Changes
There have been no significant changes in the operation
or financial condition of our company since June 30, 2019.
ITEM
9. THE OFFER AND LISTING
A. Offer
and Listing Details
Australian Securities
Exchange
Our ordinary shares have traded on the ASX since April 30, 1999
under the symbol IMC.
NASDAQ Capital Market
Our ADSs and Warrants
have been listed on The NASDAQ Capital Market under the symbol “IMRN” and “IMRNW”, respectively, since
June 13, 2017.
B. Plan
of Distribution
Not applicable.
C. Markets
The principal listing of
our ordinary shares is on the ASX, and since June 9, 2017, our ADSs and warrants have traded on The Nasdaq Capital Market.
D. Selling
Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses
of the Issue
Not applicable.
ITEM
10. ADDITIONAL INFORMATION
A. Share
Capital
Not applicable.
B. Memorandum and
Articles of Association
Our Constitution
Our Constitution is similar
in nature to the bylaws of a U.S. corporation. It does not provide for or prescribe any specific objectives or purposes of our
company. Our Constitution is subject to the terms of the ASX Listing Rules and the Corporations Act. It may be amended or repealed
and replaced by special resolution of shareholders, which is a resolution passed by at least 75% of the votes cast by shareholders
entitled to vote on the resolution.
Under Australian law, a
company has the legal capacity and powers of an individual both within and outside Australia. The material provisions of our Constitution
are summarized below. This summary is not intended to be complete or to constitute a definitive statement of the rights and liabilities
of our shareholders. Our Constitution is filed as an exhibit to this Annual Report.
Interested Directors
A director may not vote in respect of any contract
or arrangement in which the director has, directly or indirectly, any material interest according to our Constitution. Such director
must not be counted in a quorum, must not vote on the matter and must not be present at the meeting while the matter is being considered.
However, that director may execute or otherwise act in respect of that contract or arrangement notwithstanding any material personal
interest.
Unless a relevant exception
applies, the Corporations Act requires our directors to provide disclosure of certain interests or conflicts of interests and prohibits
directors from voting on matters in which they have a material personal interest and from being present at the meeting while the
matter is being considered. In addition, the Corporations Act and the ASX Listing Rules require shareholder approval of any provision
of related party benefits to our directors.
Borrowing Powers Exercisable by Directors
Pursuant to our Constitution,
the management and control of our business affairs are vested in our board of directors. Our board of directors has the power to
raise or borrow money, and charge any of our property or business or any uncalled capital, and may issue debentures or give any
other security for any of our debts, liabilities or obligations or of any other person, in each case, in the manner and on terms
it deems fit.
Retirement of Directors
Pursuant to our Constitution
and the ASX Listing Rules, there must be an election of directors at each annual general meeting. The directors, other than the
managing director, who are to stand for election at each annual general meeting are: (i) any director required to retire after
a period of three years in office, (ii) any director appointed by the other directors in the year preceding the annual general
meeting, (iii) any new directors, or (iv) if no person is standing for election for the aforementioned reasons then the director
longest in office since last being elected. A director, other than the director who is the Chief Executive Officer, must retire
from office at the conclusion of the third annual general meeting after which the director was elected. Retired directors are eligible
for a re-election to the board of directors unless disqualified from acting as a director under the Corporations Act or our Constitution.
Rights and Restrictions on Classes of Shares
The rights attaching to
our ordinary shares are detailed in our Constitution. Our Constitution provides that our directors may issue shares with preferred,
deferred or other special rights, whether in relation to dividends, voting, return of share capital or otherwise as our board of
directors may determine. Subject to any approval which is required from our shareholders under the Corporations Act and the ASX
Listing Rules (see “—Exemptions from Certain NASDAQ Corporate Governance Rules” and “—Change of Control”),
any rights and restrictions attached to a class of shares, we may issue further shares on such terms and conditions as our board
of directors resolve. Currently, our outstanding share capital consists of only one class of ordinary shares.
Dividend Rights
Our board of directors
may from time to time determine to pay dividends to shareholders. All dividends unclaimed for one year after having been declared
may be invested or otherwise made use of by our board of directors for our benefit until claimed or otherwise disposed of in accordance
with our Constitution.
Voting Rights
Under our Constitution,
and subject to any voting exclusions imposed under the ASX Listing Rules (which typically exclude parties from voting on resolutions
in which they have an interest), the rights and restrictions attaching to a class of shares, each shareholder has one vote on a
show of hands at a meeting of the shareholders unless a poll is demanded under the Constitution or the Corporations Act. On a poll
vote, each shareholder shall have one vote for each fully paid share and a fractional vote for each share held by that shareholder
that is not fully paid, such fraction being equivalent to the proportion of the amount that has been paid to such date on that
share. Shareholders may vote in person or by proxy, attorney or representative. Under Australian law, shareholders of a public
company are not permitted to approve corporate matters by written consent. Our Constitution does not provide for cumulative voting.
Note that ADS holders may
not directly vote at a meeting of the shareholders but may instruct the depositary to vote the number of deposited ordinary shares
their ADSs represent.
Right to Share in Our Profits
Pursuant to our Constitution,
our shareholders are entitled to participate in our profits only by payment of dividends. Our board of directors may from time
to time determine to pay dividends to the shareholders; however, no dividend is payable except in accordance with the thresholds
set out in the Corporations Act.
Rights to Share in the Surplus in the Event
of Liquidation
Our Constitution provides
for the right of shareholders to participate in a surplus in the event of our liquidation, subject to the rights attaching to a
class of shares.
Redemption Provision for Ordinary Shares
There are no redemption
provisions in our Constitution in relation to ordinary shares. Under our Constitution, any preference shares may be issued on the
terms that they are, or may at our option be, liable to be redeemed.
Variation or Cancellation of Share Rights
Subject to the terms of
issue of shares of that class, the rights attached to shares in a class of shares may only be varied or cancelled by a special
resolution of our company together with either:
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a special resolution passed at a separate general
meeting of members holding shares in the class; or
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the written consent of members with at least 75% of
the shares in the class.
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Directors May Make Calls
Our Constitution provides
that subject to the terms on which the shares have been issued directors may make calls on a shareholder for amounts unpaid on
shares held by that shareholder, other than monies payable at fixed times under the conditions of allotment. Shares represented
by the ADSs are fully paid and are not be subject to calls by directors.
General Meetings of Shareholders
General meetings of shareholders
may be called by our board of directors. Except as permitted under the Corporations Act, shareholders may not convene a meeting.
The Corporations Act requires the directors to call and arrange to hold a general meeting on the request of shareholders with at
least 5% of the votes that may be cast at a general meeting or at least 100 shareholders who are entitled to vote at the general
meeting. Notice of the proposed meeting of our shareholders is required at least 28 clear days prior to such meeting under the
Corporations Act.
Foreign Ownership Regulation
There
are no limitations on the rights to own securities imposed by our Constitution. However, acquisitions and proposed acquisitions
of securities in Australian companies may be subject to review and approval by the Australian Federal Treasurer under the Foreign
Acquisitions and Takeovers Act 1975, or the FATA, which generally applies to acquisitions or proposed acquisitions:
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by a foreign person (as defined in the FATA) or associated
foreign persons that would result in such persons having an interest in 20% or more of the issued shares of, or control of 20%
or more of the voting power in, an Australian company; and
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by non-associated foreign persons that would result
in such foreign person having an interest in 40% or more of the issued shares of, or control of 40% or more of the voting power
in, an Australian company, where the Australian company is valued above the monetary threshold prescribed by FATA.
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However, no such review
or approval under the FATA is required if the foreign acquirer is a U.S. entity and the value of the target is less than A$1.094
million.
The Australian Federal
Treasurer may prevent a proposed acquisition in the above categories or impose conditions on such acquisition if the Treasurer
is satisfied that the acquisition would be contrary to the national interest. If a foreign person acquires shares or an interest
in shares in an Australian company in contravention of the FATA, the Australian Federal Treasurer may order the divestiture of
such person’s shares or interest in shares in that Australian company.
Ownership Threshold
There are no provisions in
our Constitution that require a shareholder to disclose ownership above a certain threshold. The Corporations Act, however, requires
a shareholder to notify us and the ASX once it, together with its associates, acquires a 5% interest in our ordinary shares, at
which point the shareholder will be considered to be a “substantial” shareholder. Further, once a shareholder owns
a 5% interest in us, such shareholder must notify us and the ASX of any increase or decrease of 1% or more in its holding of our
ordinary shares, and must also notify us and the ASX on its ceasing to be a “substantial” shareholder.
Issues of Shares and Change in Capital
Subject
to our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, we may at any time issue shares
and grant options or warrants on any terms, with preferred, deferred or other special rights and restrictions and for the consideration
and other terms that the directors determine.
Subject to the requirements
of our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, including relevant shareholder approvals,
we may consolidate or divide our share capital into a larger or smaller number by resolution, reduce our share capital (provided
that the reduction is fair and reasonable to our shareholders as a whole and does not materially prejudice our ability to pay creditors)
or buy back our ordinary shares whether under an equal access buy-back or on a selective basis.
Change of Control
Takeovers of listed Australian
public companies, such as ours are regulated by the Corporations Act, which prohibits the acquisition of a “relevant interest”
in issued voting shares in a listed company if the acquisition will lead to that person’s or someone else’s voting
power in our company increasing from 20% or below to more than 20% or increasing from a starting point that is above 20% and below
90%, subject to a range of exceptions.
Generally, a person will have a relevant interest
in securities if the person:
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is the holder of the securities;
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has power to exercise, or control the exercise of,
a right to vote attached to the securities; or
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has the power to dispose of, or control the exercise
of a power to dispose of, the securities, including any indirect or direct power or control.
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If, at a particular time, a person has a relevant
interest in issued securities and the person:
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has entered or enters into an agreement with another
person with respect to the securities;
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has given or gives another person an enforceable right,
or has been or is given an enforceable right by another person, in relation to the securities (whether the right is enforceable
presently or in the future and whether or not on the fulfillment of a condition);
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has granted or grants an option to, or has been or
is granted an option by, another person with respect to the securities; or
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the other person would have a relevant interest in
the securities if the agreement were performed, the right enforced or the option exercised; the other person is presumed to already
have a relevant interest in the securities.
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There are a number of exceptions
to the above prohibition on acquiring a relevant interest in issued voting shares above 20%. In general terms, some of the more
significant exceptions include:
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when the acquisition results from the acceptance of
an offer under a formal takeover bid;
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when the acquisition is conducted on market by or
on behalf of the bidder under a takeover bid, the acquisition occurs during the bid period, the bid is for all the voting shares
in a bid class and the bid is unconditional or only conditioned on prescribed matters set out in the Corporations Act;
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when shareholders of our company approve the takeover
by resolution passed at general meeting;
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an acquisition by a person if, throughout the six
months before the acquisition, that person or any other person has had voting power in our company of at least 19% and, as a result
of the acquisition, none of the relevant persons would have voting power in our company more than three percentage points higher
than they had six months before the acquisition;
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when the acquisition results from the issue of securities
under a rights issue;
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when the acquisition results from the issue of securities
under dividend reinvestment schemes;
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when the acquisition results from the issue of securities
under underwriting arrangements;
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when the acquisition results from the issue of securities
through operation of law;
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an acquisition that arises through the acquisition
of a relevant interest in another listed company which is listed on a prescribed financial market or a financial market approved
by ASIC;
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an acquisition arising from an auction of forfeited
shares conducted on-market; or
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an acquisition arising through a compromise, arrangement,
liquidation or buy-back.
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Breaches
of the takeovers provisions of the Corporations Act are criminal offenses. ASIC and the Australian Takeover Panel have a wide range
of powers relating to breaches of takeover provisions, including the ability to make orders canceling contracts, freezing transfers
of, and rights attached to, securities, and forcing a party to dispose of securities. There are certain defenses to breaches of
the takeover provisions provided in the Corporations Act.
Access to and Inspection of Documents
Inspection of our records
is governed by the Corporations Act. Any member of the public has the right to inspect or obtain copies of our registers on the
payment of a prescribed fee. Shareholders are not required to pay a fee for inspection of our registers or minute books of the
meetings of shareholders. Other corporate records, including minutes of directors’ meetings, financial records and other
documents, are not open for inspection by shareholders. Where a shareholder is acting in good faith and an inspection is deemed
to be made for a proper purpose, a shareholder may apply to the court to make an order for inspection of our books.
C. Material
Contracts
We entered into
a Development and Supply Agreement with Synlait Milk Ltd. on June 21, 2016, which is currently under renegotiation. Pursuant to
the agreement, Synlait Milk, a large dairy farm company located in New Zealand, agreed to vaccinate their cow herds with IMM- 124E
vaccine and to collect the hyperimmune colostrum from the first milking of the cows at calving. This colostrum, which contains
the vaccine antibodies, is then spray or freeze dried and tested for the vaccine properties. If levels of the vaccine are sufficient
and meet our product specifications, the dried hyperimmune colostrum is then shipped to our warehouse in Melbourne, Australia. Consideration paid to Synlait Mild Ltd during the 2018 fiscal year was A$630,192.
On February 16, 2016, we entered into a Convertible
Security and Share Purchase Agreement with SBI Investments which provided us with a line of funding from which we could draw down
funding to continue our ongoing operations. The convertible note comprised of three tranches, of which we drew down the first two
tranches, totaling A$1.2 million in the aggregate. The note was repayable in 18 equal monthly installments payable on the 15th
day of each month either by the issuance of equity at a discount to the market rate at the time of issue, or by a cash payment
plus a 2.5% premium. The final payment with respect to this convertible note was repaid on September 10, 2017.
D. Exchange
Controls
Australia has largely abolished
exchange controls on investment transactions. The Australian dollar is freely convertible into U.S. dollars. In addition, there
are currently no specific rules or limitations regarding the export from Australia of profits, dividends, capital, or similar funds
belonging to foreign investors, except that certain payments to non-residents must be reported to the Australian Cash Transaction
Reports Agency, which monitors such transactions, and amounts on account of potential Australian tax liabilities may be required
to be withheld unless a relevant taxation treaty can be shown to apply.
The Foreign Acquisitions and Takeovers Act 1975
Under Australian law, in
certain circumstances foreign persons are prohibited from acquiring more than a limited percentage of the shares in an Australian
company without notification to or approval from the Australian Treasurer. These limitations are set forth in the Australian Foreign
Acquisitions and Takeovers Act, or the Takeovers Act.
Under the Takeovers Act,
as currently in effect, any foreign person, together with associates, is prohibited from acquiring 15% or more of the shares in
any company having total assets exceeding A$252 million or more. In addition, a foreign person may not acquire shares in a company
having total assets of A$252 million or more if, as a result of that acquisition, the total holdings of all foreign persons and
their associates will exceed 40% in aggregate without the approval of the Australian Treasurer. However, for “U.S. Investors”
and investors from certain other countries, a threshold of A$1.094 million applies (except in certain circumstances) to each of
the previous acquisitions. A “U.S. Investor” is defined by the Takeovers Act as a U.S. national or a U.S. enterprise.
If the necessary approvals
are not obtained, the Treasurer may make an order requiring the acquirer to dispose of the shares it has acquired within a specified
period of time. Under the current Australian foreign investment policy, however, it is unlikely that the Treasurer would make such
an order where the level of foreign ownership exceeds 40% in the ordinary course of trading, unless the Treasurer finds that the
acquisition is contrary to the national interest. The same rule applies if the total holdings of all foreign persons and their
associates already exceeds 40% and a foreign person (or its associate) acquires any further shares, including in the course of
trading in the secondary market of the ADSs. At present, we do not have total assets of A$252 million.
If the level of foreign
ownership exceeds 40% at any time, we would be considered a foreign person under the Takeovers Act. In such event, we would be
required to obtain the approval of the Treasurer for our company, together with our associates, to acquire (i) more than 15% of
an Australian company or business with assets totaling over A$252 million; or (ii) any direct or indirect ownership interest in
Australian residential real estate.
The percentage of foreign
ownership in our company would also be included in determining the foreign ownership of any Australian company or business in which
it may choose to invest. Since we have no current plans for any such acquisitions and do not own any property, any such approvals
required to be obtained by us as a foreign person under the Takeovers Act will not affect our current or future ownership or lease
of property in Australia.
Our Constitution does not contain any additional
limitations on a non-resident’s right to hold or vote our securities.
Australian law requires
the transfer of shares in our company to be made in writing. No stamp duty will be payable in Australia on the transfer of ADSs.
E. Taxation
The following is a discussion
of Australian and U.S. tax considerations material to our shareholders. To the extent that the discussion is based on tax legislation
which has not been subject to judicial or administrative interpretation, the views expressed in the discussion might not be accepted
by the tax authorities in question or by court. The discussion is not intended, and should not be construed, as legal or professional
tax advice and does not exhaust all possible tax considerations.
Holders of our ADSs should consult their
own tax advisors as to the United States, Australian or other tax consequences of the purchase, ownership and disposition of ADSs,
including, in particular, the effect of any foreign, state or local taxes.
AUSTRALIAN TAX CONSIDERATIONS
In this section we discuss
the material Australian tax considerations that apply to non-Australian tax residents with respect to the acquisition, ownership
and disposal of the absolute beneficial ownership of ADSs, which are evidenced by ADRs. This discussion is based upon existing
Australian tax law as of the date of this annual report, which is subject to change, possibly retrospectively. This discussion
does not address all aspects of Australian income tax law which may be important to particular investors in light of their individual
investment circumstances, such as ADSs or shares held by investors subject to special tax rules (for example, financial institutions,
insurance companies or tax exempt organizations). In addition, this summary does not discuss any foreign or state tax considerations,
other than stamp duty.
Prospective investors
are urged to consult their tax advisors regarding the Australian and foreign income and other tax considerations of the purchase,
ownership and disposition of the ADSs or shares.
Nature of ADSs for Australian Taxation Purposes
Holders of our ADSs are treated as the owners of
the underlying ordinary shares for Australian income tax and capital gains tax purposes.
Therefore, dividends paid on the underlying ordinary
shares will be treated for Australian tax purposes as if they were paid directly to the owners of ADSs, and the disposal of ADSs
will be treated for Australian tax purposes as the disposal of the underlying ordinary shares. In the following analysis we discuss
the application of the Australian income tax and capital gains tax rules to non-Australian resident holders of ADSs.
Taxation of Dividends
Australia operates a dividend
imputation system under which dividends may be declared to be ‘franked’ to the extent of tax paid on company profits.
Fully franked dividends are not subject to dividend withholding tax. Dividends that are not franked or are partly franked and are
paid to non-Australian resident shareholders are subject to dividend withholding tax, but only to the extent the dividends are
not franked.
Unfranked dividends paid to
a non-resident shareholder are subject to withholding tax at 30%, unless the shareholder is a resident of a country with which
Australia has a double taxation agreement. In accordance with the provisions of the Double Taxation Convention between Australia
and the U.S., the maximum rate of Australian tax on unfranked dividends to which a resident of the U.S. is beneficially entitled
is 15%, where the U.S. resident holds less than 10% of the voting rights in our company, or 5% where the U.S. resident holds 10%
or more of the voting rights in our company. The Double Taxation Convention between Australia and the U.S. does not apply to limit
the tax rate on dividends where the ADSs are effectively connected to a permanent establishment or a fixed base carried on by the
owner of the ADSs in Australia through which the shareholder carries on business or provides independent personal services, respectively.
Tax on Sales or other Dispositions of Shares -
Capital Gains Tax
Australian capital gains derived
by non-Australian residents in respect of the disposal of capital assets that are not taxable Australian property will be disregarded.
Non-Australian resident shareholders will not be subject to Australian capital gains tax on the capital gain made on a disposal
of our shares, unless they, together with associates, hold 10% or more of our issued capital, tested either at the time of disposal
or over any continuous 12 month period in the 24 months prior to disposal, and the value of our shares at the time of disposal
are wholly or principally attributable to Australian real property assets.
Australian capital gains tax
applies to net capital gains at a taxpayer’s marginal tax rate. Previously, certain shareholders, such as individuals were
entitled to a discount of 50% for capital gains on shares held for greater than 12 months. However, as part of the 2012-2013 Federal
Budget measures, the Australian Government announced changes to the application of the CGT discount for foreign resident individuals
on taxable Australian assets, including shares. These changes became effective on 29 June 2013.
The effect of the change is to:
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Retain access to the full CGT discount for discount
capital gains of foreign resident individuals in respect of the increase in the value of a CGT asset that occurred before 9 May
2013; and
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Remove the CGT discount for discount capital gains
for foreign resident individuals that arise after 8 May 2013.
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Foreign residents will
still have access to a discount on discount capital gains accrued prior to 8 May 2013 provided they choose to obtain a market valuation
for their assets as at that date.
Net capital gains are calculated after reduction
for capital losses, which may only be offset against capital gains.
Tax on Sales or other Dispositions of Shares -
Shareholders Holding Shares on Revenue Account
Some non-Australian resident
shareholders may hold shares on revenue rather than on capital account, for example, share traders. These shareholders may have
the gains made on the sale or other disposal of the shares included in their assessable income under the ordinary income provisions
of the income tax law, if the gains are sourced in Australia.
Non-Australian resident
shareholders assessable under these ordinary income provisions in respect of gains made on shares held on revenue account would
be assessed for such gains at the Australian tax rates for non-Australian residents, which start at a marginal rate of 32.5% for
non-Australian resident individuals. Some relief from the Australian income tax may be available to such non-Australian resident
shareholders under the Double Taxation Convention between the U.S. and Australia, for example, because the shareholder does not
have a permanent establishment in Australia.
To the extent an amount
would be included in a non-Australian resident shareholder’s assessable income under both the capital gains tax provisions
and the ordinary income provisions, the capital gain amount would generally be reduced, so that the shareholder would not be subject
to double tax on any part of the income gain or capital gain.
Dual Residency
If a shareholder were a resident
of both Australia and the U.S. under those countries’ domestic taxation laws, that shareholder may be subject to tax as an
Australian resident. If, however, the shareholder is determined to be a U.S. resident for the purposes of the Double Taxation Convention
between the U.S. and Australia, the Australian tax applicable would be limited by the Double Taxation Convention. Shareholders
should obtain specialist taxation advice in these circumstances.
Stamp
Duty
A
transfer of shares of a company listed on the ASX is not subject to Australian stamp duty except in some circumstances where one
person, or associated persons, acquires 90% or more of the shares.
Australian
Death Duty
Australia
does not have estate or death duties. No capital gains tax liability is realized upon the inheritance of a deceased person’s
shares.
The
disposal of inherited shares by beneficiaries, may, however, give rise to a capital gains tax liability.
Goods
and Services Tax
The
issue or transfer of shares will not incur Australian goods and services.
UNITED
STATES FEDERAL INCOME TAX CONSIDERATIONS
The
following is a summary of certain material U.S. federal income tax consequences that generally apply to U.S. Holders (as defined
below) who hold ADSs as capital assets. This summary is based on the U.S. Internal Revenue Code of 1986, as amended (the “Code”),
Treasury regulations promulgated thereunder, judicial and administrative interpretations thereof, and the bilateral taxation convention
between Australia and the U.S. (the “Tax Treaty”), all as in effect on the date hereof and all of which are subject
to change either prospectively or retroactively.
This
summary does not discuss all the tax consequences that may be relevant to an investment in ADSs by a U.S. Holder in light of such
holder’s particular circumstances or to U.S. Holders subject to special rules, including broker-dealers, banks or other
financial institutions, traders in securities who elect to use a mark-to-market method of accounting for securities holdings,
insurance companies, investors liable for alternative minimum tax, tax-exempt organizations, regulated investment companies or
real estate investment trusts, non-resident aliens of the U.S. or taxpayers whose functional currency is not the U.S. dollar,
partnerships or other pass-through entities for U.S. federal income tax purposes or persons holding ADSs through any such entities,
persons who acquired their ADSs through the exercise or cancellation of any employee stock options or otherwise as compensation
for their services, investors that actually or constructively own 10% or more of our shares by vote or value, and investors holding
ADSs as part of a straddle or appreciated financial position or as part of a hedging or conversion transaction.
If
a partnership or an entity treated as a partnership for U.S. federal income tax purposes owns ADSs, the U.S. federal income tax
treatment of a partner in such a partnership will generally depend upon the status of the partner and the activities of the partnership.
A partnership that owns ADSs and each partner in such partnership should consult its own tax advisors about the U.S. federal income
tax consequences of holding and disposing of ADSs.
This
summary does not address the effect of any U.S. federal taxation other than U.S. federal income taxation. In addition, this summary
does not include any discussion of U.S. federal estate and gift tax, state, local or foreign taxation. You are urged to consult
your tax advisors regarding the particular U.S. federal income tax consequences to you relating to the purchase, ownership and
disposition of ADSs, the consequences to you under any foreign taxing jurisdiction, as well as the U.S. federal, state and local
tax considerations of an investment in ADSs.
For
purposes of this summary, the term “U.S. Holder” means an (i) individual who is a citizen or, for U.S. federal income
tax purposes, a resident of the U.S., (ii) a corporation or other entity taxable as a corporation created or organized in or under
the laws of the U.S. or any political subdivision thereof, (iii) an estate whose income is subject to U.S. federal income tax
regardless of its source, or (iv) a trust if (a) a court within the U.S. is able to exercise primary supervision over administration
of the trust, and one or more U.S. persons have the authority to control all substantial decisions of the trust or (b) it has
a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.
Taxation
of Dividends on ADSs
For
U.S. federal income tax purposes, U.S. Holders of ADSs will be treated as owning the underlying ordinary shares represented by
the ADSs held by them. Subject to the passive foreign investment company, or PFIC rules discussed below, the gross amount of any
distributions received with respect to the underlying ordinary shares represented by the ADSs, including the amount of any taxes
withheld therefrom, will constitute dividends for U.S. federal income tax purposes, to the extent of our current and accumulated
earnings and profits, as determined under U.S. federal income tax principles. You will be required to include this amount of dividends
in gross income as ordinary income. Distributions in excess of our earnings and profits will be treated as a non-taxable return
of capital to the extent of your tax basis in the ADSs, and any amount in excess of your tax basis will be treated as gain from
the sale of ADSs. See “Disposition of ADSs” below for the discussion on the
taxation of capital gains. Dividends will not qualify for the dividends-received deduction generally available to corporations
under Section 243 of the Code.
Dividends
that we pay in Australian dollars, including the amount of any Australian taxes withheld therefrom, will be included in your income
in a U.S. dollar amount calculated by reference to the exchange rate in effect on the day such dividends are received. A U.S.
Holder who receives payment in Australian dollars and converts Australian dollars into U.S. dollars at an exchange rate other
than the rate in effect on such day will likely have a foreign currency exchange gain or loss, which would be treated as U.S.-source
ordinary income or loss.
Subject
to complex limitations, any Australian withholding tax imposed on our dividends will be a foreign income tax eligible for credit
against a U.S. Holder’s U.S. federal income tax liability (or, alternatively, for deduction against income in determining
such tax liability). The limitations set forth in the Code include computational rules under which foreign tax credits allowable
with respect to specific classes of income cannot exceed the U.S. federal income taxes otherwise payable with respect to each
such class of income. Dividends generally will be treated as foreign-source passive category income or general category income
for U.S. foreign tax credit purposes, depending upon the holder’s circumstances. The rules relating to the determination
of the foreign tax credit are complex. You should consult with your own tax advisors to determine whether and to what extent you
would be entitled to this credit.
Subject
to certain limitations, “qualified dividend income” received by a non-corporate U.S. Holder will be subject to tax
at a reduced maximum tax rate of 20 percent. Distributions taxable as dividends generally qualify for the 20 percent rate provided
that either: (i) the issuer is entitled to benefits under the Tax Treaty or (ii) the ADSs are readily tradable on an established
securities market in the U.S. and certain other requirements are met. We believe that we are entitled to benefits under the Tax
Treaty and that the ADSs currently are readily tradable on an established securities market in the U.S. However, no assurance
can be given that the ADSs will remain readily tradable. Furthermore, the reduced rate does not apply to dividends received from
PFICs. The amount of foreign tax credit is limited in the case of foreign qualified dividend income. U.S. Holders of ADSs should
consult their own tax advisors regarding the effect of these rules in their particular circumstances.
Disposition
of ADSs
If
you sell or otherwise dispose of ADSs, you will recognize gain or loss for U.S. federal income tax purposes in an amount equal
to the difference between the amount realized on the sale or other disposition and your adjusted tax basis in the ADSs. Subject
to the PFIC rules discussed below, such gain or loss generally will be capital gain or loss and will be long-term capital gain
or loss if you have held the ADSs for more than one year at the time of the sale or other disposition. In general, any gain that
you recognize on the sale or other disposition of ADSs will be U.S.-source for purposes of the foreign tax credit limitation;
losses will generally be allocated against U.S.-source income. Deduction of capital losses is subject to certain limitations under
the Code. U.S. Holders are urged to consult their tax advisors regarding the tax consequences that may occur when a foreign withholding
tax is imposed on a disposition of our ADSs, including the availability of the foreign tax credit under such U.S. Holder’s
particular circumstances.
Passive
Foreign Investment Company
The
Code provides special, generally adverse, rules regarding certain distributions received by U.S. Holders with respect to, and
sales, exchanges and other dispositions, including pledges, of, shares of stock of a PFIC. A foreign corporation will be a PFIC
for any taxable year if at least 75% of its gross income for the taxable year is passive income or at least 50% of its gross assets
during the taxable year, based on a quarterly average and generally by value, produce or are held for the production of passive
income. Passive income for this purpose generally includes, among other things, dividends, interest, rents, royalties, gains from
commodities and securities transactions and gains from the disposition of assets that produce or are held for the production of
passive income. In determining whether a foreign corporation is a PFIC, a pro-rata portion of the income and assets of each corporation
in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account.
Based
on our business results for the last fiscal year and the composition of our assets, we believe that we were not a PFIC for
U.S. federal income tax purposes for the taxable year ended June 30, 2019. However, the determination of PFIC status is a
factual determination that must be made annually at the close of each taxable year and therefore, there can be no certainty
as to our PFIC status for a taxable year until the close of that taxable year. Our PFIC status could change depending upon,
among other things, a decrease in the trading price of our ordinary shares or ADSs and how quickly we make use of the cash
proceeds from any offering, as well as changes in the composition and relative values of our assets and the composition of
our income. Moreover, the rules governing whether certain assets are active or passive are complex and in some cases their
application can be uncertain. If we were a PFIC in any year during a U.S. Holder’s holding period for the ordinary
shares or ADSs, we generally would continue to be treated as a PFIC for each subsequent year during which the U.S. Holder
owned the ordinary shares or ADSs.
If
we are a PFIC for any taxable year during which a U.S. Holder holds ordinary shares or ADSs, any “excess distribution”
that the holder receives and any gain recognized from a sale or other disposition (including a pledge) of such ordinary shares
or ADSs will be subject to special tax rules, unless the U.S. Holder makes a mark-to-market election (provided the ADSs are “marketable”)
or qualified electing fund election, as discussed below. Any distribution in a taxable year that is greater than 125% of the average
annual distribution received by a U.S. Holder during the shorter of the three preceding taxable years or such holder’s holding
period for the ordinary shares or ADSs will be treated as an excess distribution. Under these special tax rules:
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●
|
the
excess distribution or gain will be allocated ratably over the U.S. Holder’s holding
period for the ordinary shares or ADSs;
|
|
●
|
the
amount allocated to the current taxable year, and any taxable year prior to the first
taxable year in which we were a PFIC in the U.S. Holder’s holding period, will
be treated as ordinary income arising in the current taxable year; and
|
|
●
|
the
amount allocated to each other year will be subject to income tax at the highest rate
in effect for that year and applicable to the U.S. Holder and the interest charge generally
applicable to underpayments of tax will be imposed on the resulting tax attributable
to each such year.
|
If
we are a PFIC, the tax liability for amounts allocated to years prior to the year of disposition or excess distribution
cannot be offset by any net operating loss, and gains (but not losses) recognized on the transfer of the ordinary shares or
ADSs cannot be treated as capital gains, even if the ordinary shares or ADSs are held as capital assets. In addition,
non-corporate U.S. Holders will not be eligible for reduced rates of taxation on any dividends that we pay if we are a PFIC
for either the taxable year in which the dividend is paid or the preceding year. Furthermore, unless otherwise provided by
the U.S. Treasury Department, each U.S. Holder of a PFIC is required to file an annual report containing such information as
the U.S. Treasury Department may require.
If
we are a PFIC for any taxable year during which any of our non-U.S. subsidiaries is also a PFIC, a U.S. Holder of ordinary shares
or ADSs during such year would be treated as owning a proportionate amount (by value) of the shares of the lower-tier PFIC for
purposes of the application of these rules to such subsidiary. You should consult your tax advisors regarding the tax consequences
if the PFIC rules apply to any of our subsidiaries.
In
certain circumstances, in lieu of being subject to the adverse tax rules discussed above, you may make an election to include
gain on the stock of a PFIC as ordinary income under a mark-to-market method, provided that such stock is regularly traded on
a qualified exchange, or “marketable”. Under current law, the mark-to-market election may be available to U.S. Holders
of ADSs if the ADSs are listed on NASDAQ, which constitutes a qualified exchange. As stated above, the ADSs will be listed on
NASDAQ. However, there can be no assurance that the ADSs will be “regularly traded” for purposes of the mark-to-market
election. It should also be noted that it is intended that only the ADSs and not the ordinary shares will be listed on NASDAQ.
While we would expect the Australian Stock Exchange, on which the ordinary shares are listed, to be considered a qualified exchange,
no assurance can be given as to whether the Australian Stock Exchange is a qualified exchange, or that the ordinary shares would
be traded in sufficient frequency to be considered regularly traded for these purposes. Additionally, because a mark-to-market
election cannot be made for equity interests in any lower-tier PFIC that we may own, a U.S. Holder that makes a mark-to-market
election with respect to its ADSs may continue to be subject to the PFIC rules with respect to any indirect investments held by
us that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. If you make an effective mark-to-market
election, you will include as ordinary income in each year that we are a PFIC, the excess of the fair market value of your ordinary
shares or ADSs at the end of your taxable year over your adjusted tax basis in such ordinary shares or ADSs. You will be entitled
to deduct as an ordinary loss in each such year the excess of your adjusted tax basis in the ordinary shares or ADSs over their
fair market value at the end of the year, but only to the extent of the net amount previously included in income as a result of
the mark-to-market election. If you make an effective mark-to-market election, any gain you recognize upon the sale or other disposition
of your ordinary shares or ADSs in a year that we are a PFIC will be treated as ordinary income and any loss will be treated as
ordinary loss, but only to the extent of the net amount previously included in income as a result of the mark-to-market election.
Any gain or loss you recognize upon the sale or other disposition of your ordinary shares or ADSs in a year when we are not a
PFIC will be a capital gain or loss. See Disposition of ADSs above for the treatment of capital gains and losses.
Your
adjusted tax basis in the ordinary shares or ADSs will be increased by the amount of any income inclusion and decreased by the
amount of any losses under the mark-to-market rules. If you make a mark-to-market election, it will be effective for the taxable
year for which the election is made and all subsequent taxable years unless the ordinary shares or ADSs are no longer regularly
traded on a qualified exchange or the IRS consents to the revocation of the election. You are urged to consult your tax advisors
about the availability of the mark-to-market election, and whether making the election would be advisable in your particular
circumstances. In the case of a valid mark-to-market election, any distributions we make would generally be subject to the rules
discussed above under “Taxation of Dividends,” except the reduced rates of taxation on any dividends received
from us would not apply if we are a PFIC.
Alternatively,
you can sometimes avoid the PFIC rules described above by electing to treat us as a “qualified electing fund” under
Section 1295 of the Code. However, this option will not be available to you because we do not intend to comply with the requirements
necessary to permit you to make this election.
U.S.
Holders are urged to contact their own tax advisors regarding the determination of whether we are a PFIC and the tax consequences
of such status.
Additional
Tax on Investment Income
U.S.
Holders that are individuals, estates, or trusts and whose income exceeds certain thresholds will be subject to a 3.8% Medicare
contribution tax on net investment income, which will include dividends on and capital gains from the sale or other taxable disposition
of ADSs, subject to certain limitations and exceptions.
Backup
Withholding and Information Reporting
Payments
in respect of ADSs may be subject to information reporting to the IRS and to U.S. backup withholding tax at a rate equal to
the fourth lowest income tax rate applicable to individuals (which, under current law, is 24%). Backup withholding will not
apply, however, if you (i) are a corporation or come within certain exempt categories and demonstrate the fact when so
required or (ii) furnish a correct taxpayer identification number and make any other required certification.
Backup
withholding is not an additional tax. Amounts withheld under the backup withholding rules may be credited against a U.S. Holder’s
U.S. tax liability. A U.S. Holder may obtain a refund of any excess amounts withheld under the backup withholding rules by timely
filing the appropriate claim for refund with the IRS, which is generally an annual income tax return.
U.S.
Holders who are individuals generally will be required to report our name, address, and such information relating to an interest
in the ADSs as is necessary to identify the class or issue of which the ADSs are a part. These requirements are subject to exceptions,
including an exception for ADSs held in accounts maintained by certain financial institutions and an exception applicable if the
aggregate value of all “specified foreign financial assets” (as defined in the Code) does not exceed $50,000.
U.S.
Holders should consult their tax advisors regarding the application of these information reporting rules.
F. Dividends And Paying Agents
Not
applicable.
G. Statement By Experts
Not
applicable.
H. Documents on display
We
are subject to the reporting requirements of the Exchange Act, as applicable to “foreign private issuers” as
defined in Rule 3b-4 thereunder. As a foreign private issuer, we are exempt from certain provisions of the Exchange Act.
Accordingly, our proxy solicitations are not subject to the disclosure and procedural requirements of Regulation 14A under
the Exchange Act, transactions in our equity securities by our officers and directors are exempt from reporting and the
“short-swing” profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not
required to file periodic reports and financial statements as frequently or as promptly as U.S. companies whose securities
are registered under the Exchange Act. However, we file with the Securities and Exchange Commission an annual report on Form
20-F containing financial statements that have been examined and reported on, with an opinion expressed by, an independent
registered public accounting firm, and we submit reports to the Securities and Exchange Commission on Form 6-K containing
(among other things) press releases and unaudited financial information for the first six months of each fiscal year. We post
our annual report on Form 20-F on our website (www.immuron.com.au/corporate-directory-and-governance) promptly following the
filing of our annual report with the Securities and Exchange Commission. The information on our website is not incorporated
by reference into this Annual Report.
This
Annual Report and the exhibits thereto and any other document we file pursuant to the Exchange Act may be inspected without charge
and copied at prescribed rates at the Securities and Exchange Commission public reference room at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You may obtain information on the operation of the Securities and Exchange Commission’s public reference
room in Washington, D.C. by calling the Securities and Exchange Commission at 1-800-SEC-0330. The Exchange Act file number for
our Securities and Exchange Commission filings is 001-38104.
The
Securities and Exchange Commission maintains a website at www.sec.gov that contains reports, proxy and information statements,
and other information regarding registrants that make electronic filings with the Securities and Exchange Commission using its
EDGAR (Electronic Data Gathering, Analysis, and Retrieval) system.
The
documents concerning our company referred to in this Annual Report may also be inspected at our offices located at Level 3, 62
Lygon Street, Carlton Victoria, Australia, 3053.
I. Subsidiary Information
Not
applicable.
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We
invest our excess cash in interest-bearing accounts and term deposits with banks in Australia. Our management believes that the
financial institutions that hold our investments are financially sound and accordingly, minimal credit risk exists with respect
to these investments. Certain of our cash equivalents are subject to interest rate risk. Due to the short duration and conservative
nature of these instruments, we do not believe that we have a material exposure to interest rate risk. Our major market risk is
changes in foreign exchange rates as we had approximately A$5,119,887 on deposit on June 30, 2019.
We
conduct our activities almost exclusively in Australia. We are required to make certain payments in U.S. dollars and other currencies,
however such payments are not significant to our operations and we believe an adverse movement in end-of-period exchange rates
would not have a material impact on our operating results. In the twelve months ended June 30, 2019, the Australian dollar depreciated
against the U.S. dollar.
We
do not currently utilize derivative financial instruments or other financial instruments subject to market risk.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt Securities
Not
applicable.
B. Warrants and Rights
Description
of the Warrants
The
following summary of certain terms of the Warrants is not complete and is subject to, and qualified in its entirety by the provisions
of the ADS Warrant Agent Agreement and Form of Global Warrant to Purchase ADSs, which are incorporated by reference as exhibits
to this annual report.
Global
Certificates, Book-entry Interests. The Warrants are represented by one or more global certificates in registered form. The
global certificate are deposited with the Warrant Agent as custodian for DTC and registered in the name of Cede & Co., as
nominee of DTC. Ownership of interests in the global warrant certificate will be limited to persons that have accounts with DTC
or persons that have accounts with DTC participants. Book-entry interests in the Warrants will be shown on, and transfers of such
interests will be effected only through records maintained by DTC and its participants. So long as the Warrants are held in global
form, DTC will be considered the sole holder of the Warrants. Beneficial owners must rely on the procedures of the participants
through which they own book-entry interests to exercise their Warrants or transfer their Warrants.
Exercisability.
The Warrants are exercisable immediately upon issuance and at any time up to the date that is five years from the date of issuance.
The Warrants are exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice
accompanied by payment in full for the number of ADSs purchased upon such exercise. We will pay the ADS issuance fee of US$0.05
per ADS and any other applicable charges and taxes in connection with any such exercise.
Maximum
Percentage. A holder of a Warrant will not have the right to exercise such Warrant, to the extent that after giving effect
to such exercise, such person (together with such person’s affiliates and certain other persons), would beneficially own
in excess of 4.99% (the “Maximum Percentage”) of the ordinary shares outstanding immediately after giving effect to
such exercise. Subject to certain exceptions, “beneficial ownership” for purposes of determining the Maximum Percentage
is calculated in accordance with Section 13(d) of the Exchange Act and the regulations of the SEC thereunder. Upon request by
a Warrant holder, we will provide current information regarding the number of our outstanding ordinary shares.
Exercise
Price. The initial exercise price per ADS purchasable upon exercise of the Warrants is US$10.00.
Restrictive
Legend Events. We will notify the Warrant Agent and each holder if we are unable to deliver ADSs via DTC transfer or otherwise
(without restrictive legend), because (a) the SEC has issued a stop order with respect to the registration statement relating
to the ADSs, (b) the SEC otherwise has suspended or withdrawn the effectiveness of such registration statement, either temporarily
or permanently, (c) we have suspended or withdrawn the effectiveness of the registration statement, either temporarily or permanently,
or (d) otherwise (each a “Restrictive Legend Event”). If a Restrictive Legend Event occurs after a Warrant holder
has exercised a Warrant in accordance with its terms but prior to the delivery of the ADSs, or if we do not cause the depositary
to timely deliver ADSs to a Warrant holder upon exercise of the Warrants, we will be obligated to pay a cash buy-in amount to
the holder of the Warrants who did not receive ADSs upon such holder’s exercise of Warrants.
Anti-Dilution
Provisions. The exercise price per Warrant and the numbers of Warrants will be subject to adjustment from time to time in
accordance with the ASX Listing Rules upon the occurrence of certain stock dividends and distributions, stock splits, stock subdivisions
and combinations, reclassifications, rights issues, or similar events affecting our ADSs or ordinary shares, or upon the occurrence
of a change in ADS ratio.
Warrant
Agent and Exchange Listing. The Warrants are issued in registered form under an ADS Warrant Agent Agreement between The Bank
of New York Mellon, as warrant agent and us and listed on the NASDAQ Capital Market under the symbol “IMRNW”.
Rights
as a Shareholder. Except as otherwise provided in the ADS Warrant Agent Agreement or by virtue of such holder’s ownership
of ADSs or ordinary shares, holders of Warrants do not have rights or privileges of a holder of ADSs or ordinary shares, including
any voting rights, until the holder exercises the Warrant.
C.
Other Securities
Not
applicable.
D.
American Depository Shares
Fees
and Charges Payable by ADS Holders
The
table below summarizes the fees and charges that a holder of our ADSs may have to pay, directly or indirectly, to our depositary,
The Bank of New York Mellon, pursuant to the Amended and Restated Deposit Agreement, between Immuron Limited and The Bank of New
York Mellon, as depositary, and Owners and Holders of the American Depositary Shares, which was filed as Exhibit 4.1 to Amendment
No.4 of our Registration Statement on Form F-1/A filed with the SEC on May 18, 2017, and the types of services and the amount
of the fees or charges paid for such services. The disclosure under this heading “Fees and Charges Payable by ADS Holders”
is subject to and qualified in its entirety by reference to the full text of the Deposit Agreement. The holder of an ADS may have
to pay fees and charges in connection with ownership of the ADS:
Persons
depositing or withdrawing shares or ADS holders must pay:
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For:
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US$5.00 (or less)
per 100 ADSs (or portion of 100 ADSs)
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Issuance of ADSs,
including issuances resulting from a distribution of shares or rights or other property
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Cancellation of
ADSs for the purpose of withdrawal, including if the Deposit Agreement terminates
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US$0.05 (or less)
per ADS
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Any cash distribution
to ADS holders
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A fee equivalent
to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance
of ADSs
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Distribution of
securities distributed to holders of deposited securities which are distributed by the depositary to ADS holders
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US$0.05 (or less)
per ADS per calendar year
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Depositary services
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Registration or
transfer fees
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Transfer and registration
of shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares
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Expenses of the
depositary
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Cable, telex and
facsimile transmissions (when expressly provided in the Deposit Agreement) converting foreign currency to U.S. dollars
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Taxes and other
governmental charges the depositary or the custodian has to pay on any ADSs or shares underlying ADSs, such as stock transfer
taxes, stamp duty or withholding taxes
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As necessary
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Any charges incurred
by the depositary or its agents for servicing the deposited securities
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As necessary
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The
depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or surrendering ADSs
for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to
investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees.
The depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly billing
investors or by charging the book-entry system accounts of participants acting for them. The depositary may collect any of its
fees by deduction from any cash distribution payable to ADS holders that are obligated to pay those fees. The depositary may generally
refuse to provide fee-attracting services until its fees for those services are paid.
From
time to time, the depositary may make payments to us to reimburse and/or share revenue from the fees collected from ADS holders,
or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance
of the ADS program. In performing its duties under the Deposit Agreement, the depositary may use brokers, dealers or other service
providers that are affiliates of the depositary and that may earn or share fees or commissions.
Fees
and Payments Made by Us to the Depositary
For
the year ended June 30, 2019, we paid The Bank of New York Mellon a total of US$3,121.40, for services pursuant to the
Annual General Meeting (AGM).
Notes
to the Consolidated Financial Statements
Note
1. Summary of Significant Accounting Policies
Corporate
Information
The consolidated financial report of Immuron
Limited (“the Company”) for the year ended June 30, 2019, 2018 and 2017 was authorized for issue in accordance with
a resolution of the Directors on October 25, 2019.
Immuron
Limited is a listed public company limited by shares incorporated and domiciled in Australia whose shares are publicly traded
on the Australian Securities Exchange (ASX) and The NASDAQ Capital Market (“NASDAQ”).
The
Group’s principal activity is oral immunotherapy research and development and product sales focused on bovine-colostrum
enriched with antibodies of choice for the treatment and prevention of a range of infectious and immune modulated diseases. Product
sales comprise Travelan and Protectyn, used for the prevention of travelers’ diarrhea.
The
financial report is a general-purpose financial report, which has been prepared in accordance with the requirements of International
Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”),
required for a for-profit entity.
The
financial report has been prepared on an accrual basis and is based primarily on historical costs. The financial report is presented
in Australian dollars, which is the Company’s functional and presentation currency. All values are rounded to the nearest
dollar unless otherwise stated.
Management
is required to make judgements, estimates and assumptions about carrying values of assets and liabilities that are not readily
apparent from other sources. The estimates and associated assumptions are based on historical experience and various other factors
that are believed to be reasonable under the circumstance, the results of which form the basis of making the judgements. Actual
results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions
to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period,
or in the period of the revision and future periods if the revision affects both current and future periods.
Accounting policies are selected
and applied in a manner which ensures that the resulting financial information satisfies the concepts of relevance and reliability,
thereby ensuring that the substance of the underlying transactions or other events is reported.
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(ii)
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Historical
cost convention
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The
financial statements have been prepared on a historical cost basis.
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(iii)
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New
and amended standards adopted by the group
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The consolidated entity has adopted all
of the new, revised or amending Accounting Standards and Interpretations issued by the IASB that are mandatory for the current
reporting period. The adoption of these Accounting Standards and Interpretations did not have any significant impact on the financial
performance or position of the consolidated entity.
The group has applied the following
standards and amendments for the first time for the annual reporting period commencing 1 July 2018:
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IFRS 9 Financial Instruments
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IFRS 15 Revenue from Contracts with Customers; and
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●
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IFRS 2 Amendments to Share-based Payment.
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The group has changed its accounting policies without making
retrospective adjustments following the adoption of IFRS 9 and IFRS 15 as discussed in this note 1. Most of the other amendments
listed above did not have any impact on the amounts recognized in prior periods and are not expected to significantly affect the
current or future periods.
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(iv)
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New
standards and interpretations not yet adopted
|
Certain new accounting standards and interpretations
have been published that are not mandatory for June 30, 2019 reporting periods and have not been early adopted by the Group. The
Group’s assessment of the impact of these new standards and interpretations is set out below.
Title of standard
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IFRS 16 Leases
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Impact
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The group has reviewed all leasing arrangements
in light of the new lease accounting rules in IFRS 16. The standard will affect the accounting for the group’s operating
leases.
As at the reporting date, the group has non-cancellable
operating lease commitments of $104,851, see note 13.
The group expects to recognize right-of-use assets
of approximately $96,824 on July 1, 2019 and lease liabilities of $98,302 (after adjustments for prepayments and accrued lease
payments recognized as at June 30, 2019). Overall net assets will be approximately $1,479 lower, and net current assets will be
$56,913 lower due to the presentation of a portion of the liability as a current liability.
The group expects that net profit after tax will
decrease by approximately $1,532 for the year ended June 30, 2020 as a result of adopting the new rules.
Operating cash flows will increase and financing
cash flows decrease by approximately $41,389 as repayment of the principal portion of the lease liabilities will be classified
as cash flows from financing activities.
The group does not act in the capacity as a lessor
and hence the group does not expect any lessor impact on the financial statements.
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Mandatory application date/ Date of adoption by
group
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The group will apply the standard from its mandatory
adoption date of July 1, 2019.
The group intends to apply the modified
retrospective transition approach and will not restate comparative amounts for the year prior to first adoption. Right-of-use
assets will be measured at the amount of the lease liability on adoption (adjusted for any prepaid or accrued lease expenses).
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There
are no other new standards and interpretations that are not yet effective and that would be expected to have a material impact
on the group in the current or future reporting periods and on foreseeable future transactions.
(v)
|
Changes to presentation
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Classification of expenses
Immuron Limited decided in the current
financial year to change the classification of its expenses in the consolidated statement of profit or loss and other comprehensive
income. We believe that this will provide more relevant information to our stakeholders as it more in line with common practice
in the industries Immuron Limited is operating in. The comparative information has been reclassified accordingly.
Expenses are now presented in the
consolidated statement of profit or loss and other comprehensive income by ‘function’ rather than ‘nature’.
A breakdown of ‘general and administrative expenses’ is provided in note 3.
The reclassification did not have
an impact on the statement of profit or loss and other comprehensive income.
Classification of interest received and interest paid
Immuron Limited decided in the current
financial year to change the classification of interest received and interest paid in the consolidated statement of cash flows
from operating to investing and financing activities, respectively. The comparative information has been reclassified accordingly, including as presented in Note 17.
Error correction to the notes to consolidated financial
statements
The improvements in the internal control
environment as set out in Item 15 Management’s Completed Action identified the below errors.
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(i)
|
Accounting and audit fees previously disclosed under ‘corporate
administrative costs’ for June 30, 2018 and 30 June 2017 were $222,973 and $146,007 respectively. This category no longer
exists with the change in presentation. Accounting and audit fees disclosed under the new expense classification category ‘general
and administrative expenses’ in note 3 for June 30, 2018 and 30 June 2017 are $555,996 and $457,676, respectively.
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(ii)
|
Segments reporting profit/(loss) previously
disclosed for HyperImmune Products and Unallocated for June 30, 2018 was $1,010,288 and $(3,613,116) respectively. The amounts
disclosed in note 16 for June 30, 2018 are $573,942 and $(3,176,770). Previously unallocated selling and marketing expenses have
now been allocated to HyperImmune products.
Segments reporting profit/(loss) previously
disclosed for Research and development and Unallocated for June 30, 2017 was $(3,394,040) and $(3,794,814) respectively. The amounts
disclosed in note 16 for June 30, 2017 are $(3,030,359) and $(4,158,495). Expenses previously allocated to Research and development
have now been moved to Unallocated in connection to the expense reclassification as mentioned above.
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The errors identified were determined not
to be material however have been revised in the June 30, 2019 financial statements as part of the reclassification adjustments
noted above.
The errors did not have an impact on the
statement of profit or loss and other comprehensive income.
Previously
issued Financial Statements
Reclassification:
Statement
of Comprehensive Income:
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|
For
the year ended June 30,
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2018
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2018
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2017
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2017
|
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AUD$
|
|
|
Reclassification
|
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|
Reclassified
|
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AUD$
|
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|
Reclassification
|
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Reclassified
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Revenue:
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|
|
|
|
|
|
|
|
Operating Revenue
|
|
|
1,842,909
|
|
|
|
-
|
|
|
|
1,842,909
|
|
|
|
1,396,197
|
|
|
|
-
|
|
|
|
1,396,197
|
|
Total Operating Revenue
|
|
|
1,842,909
|
|
|
|
-
|
|
|
|
1,842,909
|
|
|
|
1,396,197
|
|
|
|
-
|
|
|
|
1,396,197
|
|
Cost of Goods Sold
|
|
|
(418,693
|
)
|
|
|
-
|
|
|
|
(418,693
|
)
|
|
|
(337,546
|
)
|
|
|
-
|
|
|
|
(337,546
|
)
|
Gross Profit
|
|
|
1,424,216
|
|
|
|
-
|
|
|
|
1,424,216
|
|
|
|
1,058,651
|
|
|
|
-
|
|
|
|
1,058,651
|
|
Sales and Marketing Costs
|
|
|
(282,241
|
)
|
|
|
282,241
|
|
|
|
-
|
|
|
|
(407,751
|
)
|
|
|
407,751
|
|
|
|
-
|
|
Freight Costs
|
|
|
(169,458
|
)
|
|
|
169,458
|
|
|
|
-
|
|
|
|
(135,377
|
)
|
|
|
135,377
|
|
|
|
-
|
|
Total Gross Profit less Direct Selling Costs
|
|
|
972,517
|
|
|
|
451,699
|
|
|
|
1,424,216
|
|
|
|
515,523
|
|
|
|
543,128
|
|
|
|
1,058,651
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income
|
|
|
1,850,401
|
|
|
|
(1,238
|
)
|
|
|
1,849,163
|
|
|
|
1,614,373
|
|
|
|
(8,386
|
)
|
|
|
1,605,987
|
|
Other gains/(losses) – net
|
|
|
-
|
|
|
|
95,167
|
|
|
|
95,167
|
|
|
|
-
|
|
|
|
(375,479
|
)
|
|
|
(375,479
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consulting, Employee and Director
|
|
|
(1,384,298
|
)
|
|
|
1,384,298
|
|
|
|
-
|
|
|
|
(1,689,521
|
)
|
|
|
1,689,521
|
|
|
|
-
|
|
Corporate Administration
|
|
|
(1,336,516
|
)
|
|
|
1,336,516
|
|
|
|
-
|
|
|
|
(1,381,809
|
)
|
|
|
1,381,809
|
|
|
|
-
|
|
Depreciation
|
|
|
(5,047
|
)
|
|
|
5,047
|
|
|
|
-
|
|
|
|
(4,922
|
)
|
|
|
4,922
|
|
|
|
-
|
|
Finance Costs
|
|
|
(18,857
|
)
|
|
|
18,857
|
|
|
|
-
|
|
|
|
(24,483
|
)
|
|
|
24,483
|
|
|
|
-
|
|
Impairment of Inventory
|
|
|
(163,600
|
)
|
|
|
163,600
|
|
|
|
-
|
|
|
|
(136,494
|
)
|
|
|
136,494
|
|
|
|
-
|
|
Marketing and Promotion
|
|
|
(370,699
|
)
|
|
|
370,699
|
|
|
|
-
|
|
|
|
(789,608
|
)
|
|
|
789,608
|
|
|
|
-
|
|
Research and Development
|
|
|
(2,257,224
|
)
|
|
|
-
|
|
|
|
(2,257,224
|
)
|
|
|
(4,630,674
|
)
|
|
|
-
|
|
|
|
(4,630,674
|
)
|
Travel and Entertainment
|
|
|
(297,606
|
)
|
|
|
297,606
|
|
|
|
-
|
|
|
|
(276,539
|
)
|
|
|
276,539
|
|
|
|
-
|
|
General and administrative expenses
|
|
|
-
|
|
|
|
(3,412,576
|
)
|
|
|
(3,412,576
|
)
|
|
|
-
|
|
|
|
(3,109,845
|
)
|
|
|
(3,109,845
|
)
|
Selling and marketing expenses
|
|
|
-
|
|
|
|
(686,714
|
)
|
|
|
(686,714
|
)
|
|
|
-
|
|
|
|
(1,271,526
|
)
|
|
|
(1,271,526
|
)
|
Finance income
|
|
|
-
|
|
|
|
1,238
|
|
|
|
1,238
|
|
|
|
-
|
|
|
|
8,386
|
|
|
|
8,386
|
|
Finance expenses
|
|
|
-
|
|
|
|
(24,199
|
)
|
|
|
(24,199
|
)
|
|
|
-
|
|
|
|
(89,654
|
)
|
|
|
(89,654
|
)
|
Loss for the period
|
|
|
(3,010,929
|
)
|
|
|
-
|
|
|
|
(3,010,929
|
)
|
|
|
(6,804,154
|
)
|
|
|
-
|
|
|
|
(6,804,154
|
)
|
Consolidated
statement of Cash Flows
|
|
2018
|
|
|
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
2017
|
|
|
|
AUD$
|
|
|
Reclassification
|
|
|
Reclassified
|
|
|
AUD$
|
|
|
Reclassification
|
|
|
Reclassified
|
|
Cash
flows Related to Operating Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Receipts from customers
|
|
|
1,601,619
|
|
|
|
-
|
|
|
|
1,601,619
|
|
|
|
1,413,676
|
|
|
|
-
|
|
|
|
1,413,676
|
|
Payments to suppliers and employees
|
|
|
(7,262,348
|
)
|
|
|
-
|
|
|
|
(7,262,348
|
)
|
|
|
(9,971,142
|
)
|
|
|
-
|
|
|
|
(9,971,142
|
)
|
Interest received
|
|
|
1,278
|
|
|
|
(1,278
|
)
|
|
|
-
|
|
|
|
8,386
|
|
|
|
(8,386
|
)
|
|
|
-
|
|
Interest and other costs of finance paid
|
|
|
(24,199
|
)
|
|
|
24,199
|
|
|
|
-
|
|
|
|
(97,051
|
)
|
|
|
97,051
|
|
|
|
-
|
|
Other - R&D Tax Concession Refund
|
|
|
2,156,206
|
|
|
|
-
|
|
|
|
2,156,206
|
|
|
|
1,615,043
|
|
|
|
-
|
|
|
|
1,615,043
|
|
Net Cash Flows Used In Operating Activities
|
|
|
(3,527,444
|
)
|
|
|
22,921
|
|
|
|
(3,504,523
|
)
|
|
|
(7,031,088
|
)
|
|
|
88,665
|
|
|
|
(6,942,423
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows Related to Investing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment for purchases of plant and equipment
|
|
|
(6,594
|
)
|
|
|
-
|
|
|
|
(6,594
|
)
|
|
|
(5,696
|
)
|
|
|
-
|
|
|
|
(5,696
|
)
|
Interest received
|
|
|
-
|
|
|
|
1,278
|
|
|
|
1,278
|
|
|
|
-
|
|
|
|
8,386
|
|
|
|
8,386
|
|
Net Cash Flows (Used In)/From Investing Activities
|
|
|
(6,594
|
)
|
|
|
1,278
|
|
|
|
(5,316
|
)
|
|
|
(5,696
|
)
|
|
|
8,386
|
|
|
|
2,690
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows Related to Financing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issues of securities
|
|
|
5,472,200
|
|
|
|
-
|
|
|
|
5,472,200
|
|
|
|
12,525,067
|
|
|
|
-
|
|
|
|
12,525,067
|
|
Capital raising costs
|
|
|
(733,152
|
)
|
|
|
-
|
|
|
|
(733,152
|
)
|
|
|
(2,132,422
|
)
|
|
|
-
|
|
|
|
(2,132,422
|
)
|
Proceeds from borrowings
|
|
|
500,000
|
|
|
|
-
|
|
|
|
500,000
|
|
|
|
500,000
|
|
|
|
-
|
|
|
|
500,000
|
|
Repayment of borrowings
|
|
|
(865,864
|
)
|
|
|
-
|
|
|
|
(865,864
|
)
|
|
|
(2,191,593
|
)
|
|
|
-
|
|
|
|
(2,191,593
|
)
|
Interest and other costs of finance paid
|
|
|
-
|
|
|
|
(24,199
|
)
|
|
|
(24,199
|
)
|
|
|
-
|
|
|
|
(97,051
|
)
|
|
|
(97,051
|
)
|
Net Cash Flows From Financing Activities
|
|
|
4,373,184
|
|
|
|
(24,199
|
)
|
|
|
4,348,985
|
|
|
|
8,701,052
|
|
|
|
(97,051
|
)
|
|
|
8,604,001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
839,146
|
|
|
|
-
|
|
|
|
839,146
|
|
|
|
1,664,268
|
|
|
|
-
|
|
|
|
1,664,268
|
|
Cash and cash equivalents at the beginning of the year
|
|
|
3,994,924
|
|
|
|
-
|
|
|
|
3,994,924
|
|
|
|
2,290,639
|
|
|
|
-
|
|
|
|
2,290,639
|
|
Effects of exchange rate changes on cash and cash equivalents
|
|
|
(106,640
|
)
|
|
|
-
|
|
|
|
(106,640
|
)
|
|
|
40,017
|
|
|
|
-
|
|
|
|
40,017
|
|
Cash and Cash Equivalents at the End of the Year
|
|
|
4,727,430
|
|
|
|
-
|
|
|
|
4,727,430
|
|
|
|
3,994,924
|
|
|
|
-
|
|
|
|
3,994,924
|
|
The
reclassifications had no impact on the net loss for each period.
This note provides a list of the significant
accounting policies adopted in the preparation of these consolidated financial statements to the extent they have not already been
disclosed in the other notes above. These policies have been consistently applied to all the years presented, unless otherwise
stated. The financial statements are for the group consisting of Immuron Limited and its subsidiaries.
Summary of significant accounting
policies
The
following is a summary of the material accounting policies adopted by the Company in the preparation of the financial report.
The accounting policies have been consistently applied, unless otherwise stated.
|
(b)
|
Principles
of consolidation
|
The consolidated
financial statements include the accounts of the Company and its wholly and majority-owned subsidiaries. Inter-company transactions
and balances, including profit from inter-company sales not yet realized outside of the Company, have been eliminated upon consolidation.
Subsidiaries are all entities
(including structured entities) over which the group has control. The Group controls an entity when the Group 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
to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the
Group. They are deconsolidated from the date that control ceases.
The acquisition method of accounting is used to account
for business combinations by the Group.
Intercompany transactions,
balances and unrealised gains on transactions between group companies are eliminated. Unrealised losses are also eliminated unless
the transaction provides evidence of an impairment of the transferred asset. Accounting policies of subsidiaries have been changed
where necessary to ensure consistency with the policies adopted by the Group.
Operating
segments are reported in a manner consistent with the internal reporting provided to the chief operating decision maker. This
has been identified as the chief executive officer.
|
(d)
|
Foreign
currency translation
|
|
(i)
|
Functional
and presentation currency
|
Items included in the
financial statements of each of the Group’s entities are measured using the currency of the primary economic environment
in which the entity operates (the ‘functional currency’). The consolidated financial statements are presented in Australian
dollar ($), which is Immuron Limited’s functional and presentation currency.
|
(ii)
|
Transactions
and balances
|
Foreign
currency transactions are translated into the functional currency using the exchange rates at the dates of the transactions. Foreign
exchange gains and losses resulting from the settlement of such transactions and from the translation of monetary assets and liabilities
denominated in foreign currencies at year end exchange rates are generally recognized in profit or loss.
Foreign exchange gains and
losses that relate to borrowings are presented in the consolidated statement of profit or loss and other comprehensive income,
within finance costs. All other foreign exchange gains and losses are presented in the consolidated statement of profit or loss
and other comprehensive income on a net basis within other gains/(losses).
Non-monetary
items that are measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair
value was determined. Translation differences on assets and liabilities carried at fair value are reported as part of the fair
value gain or loss. For example, translation differences on non-monetary assets and liabilities such as equities held at fair
value through profit or loss are recognized in profit or loss as part of the fair value gain or loss and translation differences
on non-monetary assets such as equities classified as at fair value through other comprehensive income are recognized in other
comprehensive income.
The results and financial position of
foreign operations (none of which has the currency of a hyperinflationary economy) that have a functional currency different from
the presentation currency are translated into the presentation currency as follows:
|
●
|
assets and liabilities for each consolidated statement
of financial position presented are translated at the closing rate at the date of that consolidated statement of financial position;
|
|
●
|
income and expenses for each consolidated statement of
profit or loss and consolidated statement of profit or loss and other comprehensive income are translated at average exchange
rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates,
in which case income and expenses are translated at the dates of the transactions); and
|
|
●
|
all resulting
exchange differences are recognized in other comprehensive income.
|
Sale of hyperimmune products
Revenue from the sale of hyperimmune products
are recognized at a point in time. The performance obligation is satisfied when the customer has access and thus control of the
product.
Financing components
The group does not expect to have any contracts
where the period between the transfer of the promised goods or services to the customer and payment by the customer exceeds one
year. As a consequence, the group does not adjust any of the transaction prices for the time value of money.
Previous accounting policy for revenue
recognition
Revenue recognition policy applicable prior to 1 July, 2018:
Revenue is measured at the fair value of
the consideration received or receivable. Amounts disclosed as revenue are net of returns, trade allowances, rebates and amounts
collected on behalf of third parties.
The company recognizes revenue when the
amount of revenue can be reliably measured, it is probable that future economic benefits will flow to the entity and specific criteria
have been met for each of the company’s activities. The amount of the revenue is not considered to be reliably measured until
all contingencies relating to the sale have been resolved.
Grants from the government are recognized
at their fair value where there is a reasonable assurance that the grant will be received and the group will comply with all attached
conditions. The Group’s research and development (R&D) activities are eligible under an Australian government tax incentive
for eligible expenditure. Management has assessed these activities and expenditure to determine which are likely to be eligible
under the incentive scheme. Amounts are recognized when it has been established that the conditions of the tax incentive have
been met and that the expected amount can be reliably measured.
The income tax expense or credit for the
period is the tax payable on the current period’s taxable income based on the applicable income tax rate for each jurisdiction
adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses.
The current income tax charge is calculated
on the basis of the tax laws enacted or substantively enacted at the end of the reporting period in the countries where the company
and its subsidiaries and associates operate and generate taxable income. Management periodically evaluates positions taken in
tax returns with respect to situations in which applicable tax regulation is subject to interpretation. It establishes provisions
where appropriate on the basis of amounts expected to be paid to the tax authorities.
Deferred income tax is provided in full,
using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying
amounts in the consolidated financial statements. However, deferred tax liabilities are not recognized if they arise from the
initial recognition of goodwill. Deferred income tax is also not accounted for if it arises from initial recognition of an asset
or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting
nor taxable profit or loss. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially
enacted by the end of the reporting period and are expected to apply when the related deferred income tax asset is realised or
the deferred income tax liability is settled.
Deferred tax assets are recognized only
if it is probable that future taxable amounts will be available to utilise those temporary differences and losses.
Current and deferred tax is recognized
in profit or loss, except to the extent that it relates to items recognized in other comprehensive income or directly in equity.
In this case, the tax is also recognized in other comprehensive income or directly in equity, respectively.
Leases in which a significant portion
of the risks and rewards of ownership are not transferred to the group as lessee are classified as operating leases (note 13).
Payments made under operating leases (net of any incentives received from the lessor) are charged to profit or loss on a straight-line
basis over the period of the lease.
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 of disposal and value in use. For the purposes of assessing impairment, assets are grouped at the lowest
levels for which there are separately identifiable cash inflows which are largely independent of the cash inflows from other assets
or groups of assets (cash-generating units). Non-financial assets other than goodwill that suffered an impairment are reviewed
for possible reversal of the impairment at the end of each reporting period.
|
(j)
|
Cash
and cash equivalents
|
For the purpose of presentation in the
consolidated statement of cash flows, cash and cash equivalents includes cash on hand, deposits held at call with financial institutions,
other short-term, highly liquid investments with original maturities of three months or less that are readily convertible to known
amounts of cash and which are subject to an insignificant risk of changes in value, and bank overdrafts. Bank overdrafts are shown
within borrowings in current liabilities in the consolidated statement of financial position.
Trade receivables are recognized initially
at fair value and subsequently measured at amortised cost using the effective interest method, less loss allowance. See note 8 for further information about the group’s accounting for trade receivables and note 20(b) for a description of the group’s
impairment policies.
|
Raw materials
and stores, work in progress and finished goods
|
Raw
materials and stores, work in progress and finished goods are stated at the lower of cost and net realizable value. Cost comprises
direct materials, direct labor and an appropriate proportion of variable and fixed overhead expenditure, the latter being allocated
on the basis of normal operating capacity. Costs are assigned to individual items of inventory on the basis of weighted average
costs. Costs of purchased inventory are determined after deducting rebates and discounts. Net realizable value is the estimated
selling price in the ordinary course of business less the estimated costs of completion and the estimated costs necessary to make
the sale.
|
(m)
|
Investments
and other financial assets
|
From 1 July 2018, the Group classifies
its financial assets in the following measurement categories:
|
●
|
those to be measured subsequently at fair value (either
through other comprehensive income (OCI) or through profit or loss); and
|
|
●
|
those to be measured at amortised cost.
|
The classification depends on
the Group’s business model for managing the financial assets and the contractual terms of the cash flows.
For assets measured at fair value, gains
and losses will either be recorded in profit or loss or OCI. For investments in equity instruments that are not held for trading,
this will depend on whether the group has made an irrevocable election at the time of initial recognition to account for the equity
investment at fair value through other comprehensive income (FVOCI).
|
(ii)
|
Recognition
and derecognition
|
Regular way purchases and sales of financial
assets are recognized on trade-date, the date on which the group commits to purchase or sell the asset. Financial assets are derecognized
when the rights to receive cash flows from the financial assets have expired or have been transferred and the group has transferred
substantially all the risks and rewards of ownership.
At initial recognition, the group measures
a financial asset at its fair value plus, in the case of a financial asset not at fair value through profit or loss (FVPL), transaction
costs that are directly attributable to the acquisition of the financial asset. Transaction costs of financial assets carried
at FVPL are expensed in profit or loss.
From 1 July 2018, the group assesses on
a forward looking basis the expected credit losses associated with its debt instruments carried at amortised cost and FVOCI. The
impairment methodology applied depends on whether there has been a significant increase in credit risk.
For trade receivables, the group applies
the simplified approach permitted by IFRS 9, which requires expected lifetime losses to be recognized from initial recognition
of the receivables, see note 20(b) for further details.
|
(v)
|
Accounting
policies applied until June 30, 2018 Classification
|
Until June 30, 2018, the group classified
its financial assets in the following categories:
|
●
|
financial assets
at fair value through profit or loss;
|
|
●
|
held-to-maturity
investments; and
|
|
●
|
available-for-sale
financial assets.
|
The classification depended on the purpose
for which the investments were acquired. Management determined the classification of its investments at initial recognition and,
in the case of assets classified as held-to-maturity, re-evaluated this designation at the end of each reporting period.
Impairment
See note 20(b) for a description of the
group’s impairment policies.
|
(vi)
|
Income
recognition Interest income
|
Interest income is recognized using the
effective interest method. When a receivable is impaired, the group reduces the carrying amount to its recoverable amount, being
the estimated future cash flow discounted at the original effective interest rate of the instrument, and continues unwinding the
discount as interest income. Interest income on impaired loans is recognized using the original effective interest rate.
|
(n)
|
Property,
plant and equipment
|
Property, plant and equipment is stated
at historical cost less depreciation. Historical cost includes expenditure that is directly attributable to the acquisition of
the items.
Subsequent costs are included in the asset’s
carrying amount or recognized as a separate asset, as appropriate, only when it is probable that future economic benefits associated
with the item will flow to the group and the cost of the item can be measured reliably. The carrying amount of any component accounted
for as a separate asset is derecognized when replaced. All other repairs and maintenance are charged to profit or loss during
the reporting period in which they are incurred.
Depreciation is calculated using the straight-line
method to allocate their cost or revalued amounts, net of their residual values, over their estimated useful lives or, in the
case of leasehold improvements and certain leased plant and equipment, the shorter lease term as follows:
●
|
Plant and equipment
|
3 - 15 years
|
●
|
Furniture and fittings
|
3 - 15 years
|
●
|
Computer equipment
|
2 - 5 years
|
The assets’ residual values and useful
lives are reviewed, and adjusted if appropriate, at the end of each reporting period.
An asset’s carrying amount is written
down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount (note
1(i)).
Gains and losses on disposals are determined
by comparing proceeds with carrying amount. These are included in profit or loss.
|
(i)
|
Research
and development
|
Expenditure on research activities, undertaken
with the prospect of obtaining new scientific or technical knowledge and understanding, is recognized in the consolidated statement
of profit or loss and other comprehensive income as an expense when it is incurred.
Expenditure on development activities,
being the application of research findings or other knowledge to a plan or design for the production of new or substantially improved
products or services before the start of commercial production or use, is capitalised if it is probable that the product or service
is technically and commercially feasible, will generate probable economic benefits, adequate resources are available to complete
development and cost can be measured reliably. Other development expenditure is recognized in the consolidated statement of profit
or loss and other comprehensive income as an expense as incurred.
|
(p)
|
Trade
and other payables
|
These amounts represent liabilities for
goods and services provided to the group prior to the end of financial year which are unpaid. The amounts are unsecured and are
usually paid within 30 days of recognition. Trade and other payables are presented as current liabilities unless payment is not
due within 12 months after the reporting period. They are recognized initially at their fair value and subsequently measured at
amortised cost using the effective interest method.
|
(i)
|
Short-term
obligations
|
Liabilities for wages and salaries, including
non-monetary benefits, annual leave and accumulating sick leave that are expected to be settled wholly within 12 months after
the end of the period in which the employees render the related service are recognized in respect of employees’ services
up to the end of the reporting period and are measured at the amounts expected to be paid when the liabilities are settled. The
liabilities are presented as current employee benefit obligations in the statement of financial position.
|
(ii)
|
Other
long-term employee benefit obligations
|
In some countries, the Group also has
liabilities for long service leave and annual leave that are not expected to be settled wholly within 12 months after the end
of the period in which the employees render the related service. These obligations are therefore measured as the present value
of expected future payments to be made in respect of services provided by employees up to the end of the reporting period using
the projected unit credit method.
Consideration is given to expected future
wage and salary levels, experience of employee departures and periods of service. Expected future payments are discounted using
market yields at the end of the reporting period of high-quality corporate bonds with terms and currencies that match, as closely
as possible, the estimated future cash outflows. Remeasurements as a result of experience adjustments and changes in actuarial
assumptions are recognized in profit or loss.
The obligations are presented as current liabilities in the statement of financial
position if the entity does not have an unconditional right to defer settlement for at least twelve months after the reporting
period, regardless of when the actual settlement is expected to occur.
|
(iii)
|
Share-based
payments
|
Share-based compensation benefits are
provided to employees via the ‘executive share and option plan’ (ESOP). Information relating to these schemes is set out in note
18.
Employee options
The fair value of options granted under
the ESOP is recognized as a share-based payment expense with a corresponding increase in equity. The total amount to be expensed
is determined by reference to the fair value of the options granted:
|
-
|
including
any market performance conditions (e.g. the company’s share price);
|
|
-
|
excluding
the impact of any service and non-market performance vesting conditions (e.g. profitability,
sales growth targets and remaining an employee of the company over a specified time period);
and
|
|
-
|
including
the impact of any non-vesting conditions (e.g. the requirement for employees to save
or holdings shares for a specific period of time).
|
The total expense is recognized over the
vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each
period, the entity revises its estimates of the number of options that are expected to vest based on the non-market vesting and
service conditions. It recognizes the impact of the revision to original estimates, if any, in profit or loss, with a corresponding
adjustment to equity.
Ordinary shares are classified as equity.
Incremental costs directly attributable
to the issue of new shares or options are shown in equity as a deduction, net of tax, from the proceeds.
Basic loss per share is calculated by
dividing:
|
●
|
the loss attributable
to owners of the company, excluding any costs of servicing equity other than ordinary
shares
|
|
●
|
by the weighted
average number of ordinary shares outstanding during the financial year, adjusted for
bonus elements in ordinary shares issued during the year.
|
|
(ii)
|
Diluted
loss per share
|
Diluted loss per share adjusts the figures
used in the determination of basic loss per share to take into account:
|
●
|
the
after income tax effect of interest and other financing costs associated with dilutive
potential ordinary shares, and
|
|
●
|
the
weighted average number of additional ordinary shares that would have been outstanding
assuming the conversion of all dilutive potential ordinary shares.
|
|
(t)
|
Goods
and services tax (GST)
|
Revenues, expenses and assets are recognized
net of the amount of associated GST, unless the GST incurred is not recoverable from the taxation authority. In this case it is
recognized as part of the cost of acquisition of the asset or as part of the expense.
Receivables and payables are stated inclusive
of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the taxation authority is included
with other receivables or payables in the consolidated statement of financial position.
Cash flows are presented on a gross basis.
The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the
taxation authority, are presented as operating cash flows.
Changes in accounting policies
This note explains the impact
of the adoption of IFRS 9 Financial Instruments and IFRS 15 Revenue from Contracts with Customers on the group’s
financial statements.
IFRS 9 Financial Instruments –
impact of adoption
IFRS 9 Financial
Instruments replaces IAS 39 Financial Instruments: Recognition and Measurement for annual periods beginning on or after
1 January 2018, bringing together all three aspects of the accounting for financial instruments: classification and measurement,
impairment and hedge accounting. The adoption of this standard has not materially impacted the amounts disclosed in these financial
statements.
|
(i)
|
Classification and measurement
|
Except for certain trade
receivables, under IFRS 9, the group initially measures a financial asset at its fair value plus, in the case of a financial asset
not at fair value through profit or loss, transaction costs.
Under IFRS 9, debt financial
instruments are subsequently measured at fair value through profit or loss (FVPL), amortised cost, or fair value through other
comprehensive income (FVOCI). The classification is based on two criteria: the group’s business model for managing the assets;
and whether the instruments’ contractual cash flows represent ‘solely payments of principal and interest’ on
the principal amount outstanding (the ‘SPPI criterion’).
The new classification and measurement
of the group’s debt financial assets are as follows:
|
●
|
Debt
instruments at amortised cost for financial assets that are held within a business model
with the objective to hold the financial assets in order to collect contractual cash
flows that meet the SPPI criterion. This category comprises trade and other receivables.
|
The assessment of the group’s business
models was made as of the date of initial application, 1 July 2018 and then applied retrospectively to those financial assets
that were not derecognized before 1 July 2018. The assessment of whether contractual cash flows on debt instruments are solely
comprised of principal and interest was made based on the facts and circumstances as at the initial recognition of the assets.
There has been no adjustment made to the amounts disclosed as a result of the application of this standard.
|
(ii)
|
Impairment
of financial assets
|
The adoption of IFRS 9 has altered the group’s
accounting for impairment losses for financial assets by replacing IAS 39’s incurred loss approach with a forward-looking
expected credit loss (ECL) approach.
IFRS 9 requires the group to record an allowance for
ECLs for all loans and other debt financial assets not held at FVPL.
ECLs are based on the difference between the contractual
cash flows due in accordance with the contract and all the cash flows that the group expects to receive. The shortfall is then
discounted at an approximation to the asset’s original effective interest rate.
For trade and other receivables,
the group has applied the standard’s simplified approach and has calculated ECLs based on lifetime expected credit losses.
The group has established a provision matrix that is based on the group’s historical credit loss experience, adjusted for
forward-looking factors specific to the debtors and the economic environment.
The adoption of the ECL requirements
of IFRS 9 has not resulted in any material change in impairment allowances of the group’s debt financial assets.
IFRS 9 Financial Instruments
– accounting policies applied from 1 July 2018
Trade receivables
The accounting policies applied
by the group from 1 July 2018 are set out in note 1(k).
Investments and other financial
assets
The accounting policies applied
by the group from 1 July 2018 are set out in note 1(m).
IFRS 15 Revenue from Contracts
with Customers – impact of adoption
IFRS 15 supersedes IAS 11 Construction Contracts,
IAS 18 Revenue and related interpretations and it applies to all revenue arising from contracts with customers, unless those
contracts are in the scope of other standards. The new standard has been applied as at 1 July 2018 using the modified retrospective
approach and establishes a five-step model to account for revenue arising from contracts with customers. Under IFRS 15, revenue
is recognized at an amount that reflects the consideration to which an entity expects to be entitled in exchange for transferring
goods or services to a customer. The standard requires entities to exercise judgement, taking into consideration all of the relevant
facts and circumstances when applying each step of the model to contracts with their customers. The standard also specifies the
accounting for the incremental costs of obtaining a contract and the costs directly related to fulfilling a contract. The adoption
of IFRS 15 has not impacted the amounts disclosed within the financial statements.
IFRS 15 Revenue from Contracts
with Customers – accounting policies applied from 1 July 2018
Revenue recognition
The accounting policies applied by the
group from 1 July 2018 are set out in note 1(e).
Critical Accounting Estimates and Judgments
Management evaluates estimates and judgments
incorporated into the financial statements based on historical knowledge and best available current information. Estimates assume
a reasonable expectation of future events and are based on current trends and economic data, obtained both internally and externally.
Share-based payments
The value attributed to share options and
remunerations shares issued is an estimate calculated using an appropriate mathematical formula based on an option pricing model.
The choice of models and the resultant option value require assumptions to be made in relation to the likelihood and timing of
the conversion of the options to shares and the value of volatility of the price of the underlying shares.
Impairment of inventories
The provision for impairment of inventories
assessment requires a degree of estimation and judgement. The level of the provision is assessed by taking into account the recent
sales experience, the ageing of inventory, and in particular, the shelf life of inventories that affects obsolescence. Expected
shelf-life is reassessed on a regular basis with reference to stability tests which are conducted by an expert engaged by the Company.
Inventory split
During the current financial period, management
has performed an assessment on its raw materials and their utilization within 12 months from reporting date and have determined
A$225,765 (2018: A$198,585) of raw materials relating to Colostrum is expected to be consumed within 12 months and the remaining
balance of A$1,862,063 (2018: A$2,171,867) is expected to be consumed after 12 months from reporting date.
During the year ended June 30, 2018, management
determined that a portion of its inventory should be reclassified on a prospective basis as a noncurrent asset as a result of a
strategic decision made by management in the intended use of its inventory. The Company decided to terminate all plans to sell
the colostrum powder to secondary markets as a result of the continued scientific evidence supporting an extended shelf life. The
extended shelf life provides the Company with the assurance that colostrum will be consumed through the production of its current
Travelan and Protectyn products throughout future reporting periods.
Provision for employee benefits
Provision for employee benefits represents
amounts accrued for annual leave and long service leave. The current portion for this provision includes the total amount accrued
for annual leave entitlements and the amounts accrued for long service leave entitlements that have vested due to employees having
completed the required period of service. Refer to note 1(q) for policies on provisions.
R&D tax incentive
The Group’s research and development
activities are eligible under an Australian Government tax incentive for eligible expenditure from July 1, 2011. Management has
assessed these activities and expenditure to determine which are likely to be eligible under the incentive scheme.
For the year ended June 30, 2019 the Group
has recorded other income of A$531,005 (2018: A$1,849,123) to recognize this amount which relates to this financial year.
Fair value measurement hierarchy
The preparation of the financial statements
requires management to make judgments, estimates and assumptions that affect the reported amounts in the financial statements.
Management continually evaluates its judgments, estimates in relation to assets, liabilities, contingent liabilities, revenue and
expenses. Management bases its judgments, estimates, and assumptions on historical experience and on other various factors, including
expectations of future events, management believes to be reasonable under the circumstances. The resulting accounting judgments
and estimates will seldom equal the related actual results. The judgments, estimates and assumptions that have a significant risk
of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed
within the relevant sections where applicable.
The fair value of the convertible notes
classified as Level 3 were determined by the use of valuation model. These include discounted cash flow analysis and the use of
observable inputs that required significant adjustments based on unobservable inputs.
Note 2. Revenue and other income
|
|
30 June
2019
|
|
|
30 June
2018
|
|
|
30 June
2017
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
Revenue from Operating Activities
|
|
|
|
|
|
|
|
|
|
Revenue from contracts
with customers
|
|
|
2,387,426
|
|
|
|
1,842,909
|
|
|
|
1,396,197
|
|
Total Revenue
from Operating Activities
|
|
|
2,387,426
|
|
|
|
1,842,909
|
|
|
|
1,396,197
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Income
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
|
|
|
1,045
|
|
|
|
40
|
|
|
|
30,672
|
|
Australian Federal R&D Tax
Concession Refund
|
|
|
531,005
|
|
|
|
1,849,123
|
|
|
|
1,575,315
|
|
Total Other
Income
|
|
|
532,050
|
|
|
|
1,849,163
|
|
|
|
1,605,987
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Gains/(Losses) – Net
|
|
|
|
|
|
|
|
|
|
|
|
|
Net foreign exchange gains/(losses)
|
|
|
51,807
|
|
|
|
258,767
|
|
|
|
(238,985
|
)
|
Net impairment losses
|
|
|
(13,394
|
)
|
|
|
(163,600
|
)
|
|
|
(136,494
|
)
|
Total Other
Gains/(Losses) – Net
|
|
|
38,413
|
|
|
|
95,167
|
|
|
|
(375,479
|
)
|
Total Revenue, Other Income and Other Gains/(Losses) – Net
|
|
|
2,957,889
|
|
|
|
3,787,239
|
|
|
|
2,626,705
|
|
Note 3. Expenses
|
|
30 June
2019
|
|
|
30 June
2018
|
|
|
30 June
2017
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
|
|
|
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
|
|
|
|
a)
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
Accounting and audit
|
|
|
496,983
|
|
|
|
555,996
|
|
|
|
457,676
|
|
Bad debts
|
|
|
50,429
|
|
|
|
77,698
|
|
|
|
—
|
|
Consulting
|
|
|
243,508
|
|
|
|
46,417
|
|
|
|
33,976
|
|
Depreciation and Amortisation
|
|
|
5,287
|
|
|
|
5,047
|
|
|
|
4,922
|
|
Employee benefits
|
|
|
1,599,023
|
|
|
|
1,281,845
|
|
|
|
1,128,496
|
|
Expected credit losses
|
|
|
34,046
|
|
|
|
—
|
|
|
|
—
|
|
Insurance
|
|
|
307,757
|
|
|
|
277,888
|
|
|
|
150,502
|
|
Investor relations
|
|
|
128,415
|
|
|
|
135,684
|
|
|
|
61,210
|
|
Legal
|
|
|
171,145
|
|
|
|
166,052
|
|
|
|
58,268
|
|
Listing and share registry
|
|
|
186,013
|
|
|
|
272,711
|
|
|
|
79,548
|
|
Occupancy
|
|
|
105,606
|
|
|
|
74,395
|
|
|
|
75,683
|
|
Share-based payments
|
|
|
1,343,500
|
|
|
|
59,975
|
|
|
|
522,665
|
|
Superannuation
|
|
|
55,176
|
|
|
|
42,478
|
|
|
|
42,551
|
|
Travel and entertainment
|
|
|
159,911
|
|
|
|
297,606
|
|
|
|
276,539
|
|
Other
|
|
|
127,329
|
|
|
|
118,784
|
|
|
|
217,809
|
|
Total General and Administrative
Expenses
|
|
|
5,014,128
|
|
|
|
3,412,576
|
|
|
|
3,109,845
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
b)
Selling and Marketing Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling
|
|
|
277,478
|
|
|
|
123,660
|
|
|
|
126,261
|
|
Marketing
|
|
|
377,427
|
|
|
|
393,596
|
|
|
|
1,009,888
|
|
Distribution
costs
|
|
|
209,739
|
|
|
|
169,458
|
|
|
|
135,377
|
|
Total
Selling and Marketing Expenses
|
|
|
864,644
|
|
|
|
686,714
|
|
|
|
1,271,526
|
|
Note 4. Income Tax Benefit
|
|
2019
AUD$
|
|
|
2018
Restated
AUD$
|
|
Unused tax losses
for which no deferred tax asset has been recognized
|
|
|
37,202,960
|
|
|
|
34,749,580
|
|
Potential tax benefit @ 27.5%
|
|
|
10,230,814
|
|
|
|
9,556,135
|
|
The unused tax losses for the year ended
June 30, 2018 have been restated to reflect the income tax returns lodged for the same period.
Numerical reconciliation of income
tax expense to prima facie tax payable
|
|
30 June
2019
|
|
|
30 June
2018
|
|
|
|
AUD$
|
|
|
AUD$
|
|
Loss from continuing operations before income tax expense
|
|
|
(4,632,743
|
)
|
|
|
(3,010,929
|
)
|
Tax at the Australian tax rate of 27.5% (2018: 27.5%)
|
|
|
(1,274,004
|
)
|
|
|
(828,005
|
)
|
Tax effect of amounts which are not deductible (taxable) in calculating taxable income:
|
|
|
|
|
|
|
|
|
R&D tax incentive
|
|
|
(146,026
|
)
|
|
|
(508,509
|
)
|
Accounting expenditure subject to R&D tax incentive
|
|
|
335,693
|
|
|
|
752,949
|
|
Share-based payments
|
|
|
369,463
|
|
|
|
16,493
|
|
Net impact of other amounts not deductible (taxable)
|
|
|
38,656
|
|
|
|
26,956
|
|
Subtotal
|
|
|
(676,218
|
)
|
|
|
(540,116
|
)
|
|
|
|
|
|
|
|
|
|
Difference in overseas tax rates
|
|
|
1,539
|
|
|
|
—
|
|
Tax losses and other timing differences for which no deferred tax asset is recognized
|
|
|
674,679
|
|
|
|
540,116
|
|
Income tax expense
|
|
|
—
|
|
|
|
—
|
|
Note 5. Key Management Personnel
Compensation
This note details the nature and amount
of remuneration for each Director of Immuron Limited, and for the Key Management Personnel.
The Directors of Immuron Limited during
the year ended 30 June 2019 were:
The following persons held office as Directors
of Immuron Limited during the financial year:
Dr Roger Aston, Independent
Non-Executive Chairman
Mr Peter Anastasiou, Executive
Vice Chairman
Dr Gary Jacob, Executive Director
(appointed 17 April 2019) and Chief Executive Officer (appointed 16 November 2018)
Mr Daniel Pollock, Independent
Non-Executive Director
Mr Stephen Anastasiou, Independent
Non-Executive Director
Prof. Ravi Savarirayan, Independent
Non-Executive Director
Mr Richard Berman, Independent
Non-Executive Director (appointed 1 July 2018)
The following persons held office as Key
Management Personnel of Immuron Limited during the financial year ended June 30, 2019:
Dr Jerry Kanellos, Chief Operating
Officer (appointed 16 November 2018), Interim Chief Executive Officer (appointed 3 August 2017; resigned 16 November 2018)
The aggregate compensation made to Directors
and Other Key Management Personnel of the Company is set out below:
|
|
30 June
2019
|
|
|
30 June
2018
|
|
|
30 June
2017
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
|
|
|
|
|
|
|
|
|
|
Key Management Personnel
Compensation
|
|
|
|
|
|
|
|
|
|
Short-term employee
benefits
|
|
|
952,406
|
|
|
|
570,256
|
|
|
|
681,666
|
|
Post-employment benefits
|
|
|
32,300
|
|
|
|
32,087
|
|
|
|
25,947
|
|
Long-term benefits
|
|
|
3,652
|
|
|
|
—
|
|
|
|
—
|
|
Share-based
payments
|
|
|
1,296,400
|
|
|
|
59,975
|
|
|
|
353,670
|
|
Total Key Management
Personnel Compensation
|
|
|
2,284,758
|
|
|
|
662,318
|
|
|
|
1,061,283
|
|
Note 6. Loss per Share
|
|
30 June
2019
|
|
|
30 June
2018
|
|
|
30 June
2017
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
AUD$
|
|
|
|
|
|
|
|
|
|
|
|
Basic/Diluted
loss per share (in cents)
|
|
|
3.20
|
|
|
|
2.30
|
|
|
|
6.40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
a) Net loss
used in the calculation of basic and diluted loss per share
|
|
|
4,632,743
|
|
|
|
3,010,929
|
|
|
|
6,804,154
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
b) Weighted
average number of ordinary shares outstanding during the period used in the calculation of basic and diluted loss per share
|
|
|
144,740,535
|
|
|
|
133,660,556
|
|
|
|
105,866,110
|
|
The Company is currently in a loss making
position and thus the impact of potential issuance of shares is concluded as anti-dilutive which includes the Company’s
options and warrants and convertible notes payable. Treasury shares are excluded from the calculation of weighted average number
of ordinary shares.
Note 7. Cash
|
|
30 June
2019
|
|
|
30 June
2018
|
|
|
|
AUD$
|
|
|
AUD$
|
|
Cash at Bank and
in hand:
|
|
|
|
|
|
|
Cash
at bank and in hand
|
|
|
5,119,887
|
|
|
|
4,727,430
|
|
Total Cash
|
|
|
5,119,887
|
|
|
|
4,727,430
|
|
Note 8. Trade and Other Receivables
|
|
30 June
2019
|
|
|
30 June
2018
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade receivables*
|
|
|
332,972
|
|
|
|
492,276
|
|
Loss allowance
|
|
|
(34,046
|
)
|
|
|
—
|
|
Other receivables
|
|
|
138,172
|
|
|
|
—
|
|
Accrued
income**
|
|
|
531,828
|
|
|
|
1,191,029
|
|
Total Trade and Other
Receivables
|
|
|
968,926
|
|
|
|
1,683,305
|
|
|
*
|
All trade receivables
are non-interest bearing.
|
|
**
|
Primarily comprises
of receivables from the Australian Tax Office in relation to R&D tax concession for
the year.
|
Classification as trade
receivables
Trade receivables are amounts due from
customers for goods sold or services performed in the ordinary course of business. They are generally due for settlement within
30 days and therefore are all classified as current. Trade receivables are recognized initially at the amount of consideration
that is unconditional unless they contain significant financing components, when they are recognized at fair value. The Group
holds the trade receivables with the objective to collect the contractual cash flows and therefore measures them subsequently
at amortised cost using the effective interest method. Details about the Group’s impairment policies and the calculation
of the loss allowance are provided in note 20(b).
Accrued receivables
These amounts primarily comprise
amounts receivable from the Australian Taxation Office in relation to the R&D tax incentive.
Fair value of trade and
other receivables
Due to the short-term nature
of the current receivables, their carrying amount is considered to be the same as their fair value.
Impairment and risk exposure
Information about the impairment
of trade receivables and the group’s exposure to credit risk, foreign currency risk and interest rate risk can be found
in note 20.
Note 9. Inventories
|
|
30 June
2019
|
|
|
30 June
2018
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
|
|
|
|
|
|
Current Inventory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Raw materials
|
|
|
225,765
|
|
|
|
198,585
|
|
Work in Progress
|
|
|
192,399
|
|
|
|
33,625
|
|
Finished goods
|
|
|
126,177
|
|
|
|
265,692
|
|
|
|
|
|
|
|
|
|
|
Total Current Inventory
|
|
|
544,341
|
|
|
|
497,902
|
|
|
|
30 June
2019
|
|
|
30 June
2018
|
|
|
|
AUD$
|
|
|
AUD$
|
|
|
|
|
|
|
|
|
Non-Current Inventory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Raw materials
|
|
|
1,862,063
|
|
|
|
2,171,867
|
|
|
|
|
|
|
|
|
|
|
Total Non-Current Inventory
|
|
|
1,862,063
|
|
|
|
2,171,867
|
|
The provision for impairment of inventories
assessment requires a degree of estimation and judgement. The level of the provision is assessed by taking into account the recent
sales experience, the ageing of inventories and in particular the shelf life of inventories that affect obsolescence. Expected
shelf-life is reassessed on a regular basis with reference to stability tests which are conducted by an expert engaged by the
group.
There was a $13,394 expired Protectyn
impairment expense recognized during year ended 30 June 2019 (2018: $163,600) for inventory obsolescence in the consolidated statement
of profit or loss and other comprehensive income.
During the year ended 30 June 2019, management
performed an assessment of its raw materials and utilisation within 12 months from reporting date. Management determined $225,765
(2018: $198,585) of raw materials relating to Colostrum will be consumed within 12 months from reporting date; the remaining balance
of $1,862,063 (2018: $2,171,867) was estimated to be consumed beyond 12 months.
Note 10. Controlled Entities
The Company’s subsidiaries at 30
June 2019 are set out below. Unless otherwise stated, they have share capital consisting solely of ordinary shares that are held
directly by the Company, and the proportion of ownership interests held equals the voting rights held by the Company. The country
of incorporation or registration is also their principal place of business.
|
|
|
|
Percentage
of Ownership
|
|
|
|
Country of
Incorporation
|
|
30
June
2019
|
|
|
30
June
2018
|
|
|
|
|
|
|
|
|
|
|
Parent Entity:
|
|
|
|
|
|
|
|
|
Immuron Limited
|
|
Australia
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiaries of Immuron
Limited:
|
|
|
|
|
|
|
|
|
|
|
Immuron Inc.
|
|
USA
|
|
|
100
|
%
|
|
|
100
|
%
|
Anadis EPS Pty Ltd
|
|
Australia
|
|
|
100
|
%
|
|
|
100
|
%
|
IMC Canada Ltd.
|
|
Canada
|
|
|
100
|
%
|
|
|
100
|
%
|
Note 11. Trade and Other Payables
|
|
30
June 2019
AUD$
|
|
|
30
June 2018
AUD$
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
Trade payables
|
|
|
715,115
|
|
|
|
216,938
|
|
Accrued expenses
|
|
|
355,825
|
|
|
|
435,280
|
|
Other payables
|
|
|
20,979
|
|
|
|
37,108
|
|
Total
|
|
|
1,091,919
|
|
|
|
689,326
|
|
Convertible Notes:
The outstanding balance of $226,000 convertible
note as at 30 June 2017 was repaid during July 2017 and August 2017 with the liability being fully extinguished by 10 September
2017. The balance as at 30 June 2018 and 30 June 2019 was nil.
Borrowings:
The financed insurance policies with a
balance of $139,864 as at 30 June 2017 were fully repaid by the Company during 2018. The balance as at 30 June 2018 and 30 June
2019 was nil.
Note 12. Contingent liabilities
The group had no contingent liabilities
at 30 June 2019 (2018: nil).
Note 13. Commitments
|
|
30 June
2019
|
|
|
|
AUD$
|
|
Commitments
for minimum lease payments in relation to non-cancellable operating leases are payable as follows1:
|
|
|
|
- not later than 12
months
|
|
|
41,389
|
|
- between
1 and 5 years
|
|
|
63,462
|
|
Total
|
|
|
104,851
|
|
|
1
|
The property lease
is a non-cancellable lease with a 3 year term, with rent payable monthly in advance.
The minimum lease payments shall be increased by CPI per annum. An option exists to renew
the lease at the end of the 3 year term for an additional term of 3 years. The current
3 year lease period expires in December 2021.
|
The Group has recognized A$89,529,
A$38,917 and A$46,082, of rental expenses in its Statement of Profit or Loss and Other Comprehensive Income for the years 2019,
2018 and 2017, respectively, as General and Administration Expense.
Note 14. Share capital
|
|
2019
Shares
|
|
|
2018
Shares
|
|
|
2017
Shares
|
|
|
2019
$
|
|
|
2018
$
|
|
|
2017
$
|
|
Ordinary shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fully paid
|
|
|
163,215,706
|
|
|
|
142,778,206
|
|
|
|
130,041,417
|
|
|
|
60,511,326
|
|
|
|
58,372,043
|
|
|
|
53,632,995
|
|
|
|
|
163,215,706
|
|
|
|
142,778,206
|
|
|
|
130,041,417
|
|
|
|
60,511,326
|
|
|
|
58,372,043
|
|
|
|
53,632,995
|
|
|
(i)
|
Movements in
ordinary shares:
|
Details
|
|
Number of
shares
|
|
|
Total
$
|
|
Balance at 1 July 2016
|
|
|
80,099,646
|
|
|
|
45,633,354
|
|
Right issue1 (2016-07-07)
|
|
|
18,045,512
|
|
|
|
—
|
|
Right issue at A$0.25 (2016-07-07)
|
|
|
3,275,466
|
|
|
|
818,867
|
|
Right issue at A$0.25 to oversubscribes and private placement (2016-09-29)
|
|
|
3,968,916
|
|
|
|
992,229
|
|
Shares issued at A$0.245 under ESOP – for 6 months service (vesting
monthly) (2016-12-02)
|
|
|
251,877
|
|
|
|
61,710
|
|
Shares issued at A$0.332 on NASDAQ (equivalent
to 610,000 ADSs) (2017-06-09)2
|
|
|
24,400,000
|
|
|
|
8,092,517
|
|
Less: Transaction costs arising on share issues
|
|
|
—
|
|
|
|
(2,037,557
|
)
|
Movement to Retained Earnings
|
|
|
—
|
|
|
|
71,875
|
|
Balance at 30 June 2017
|
|
|
130,041,417
|
|
|
|
53,632,995
|
|
Issue at A$0.19 on conversion of convertible notes (2017-07-28)
|
|
|
399,045
|
|
|
|
75,333
|
|
Issue at A$0.16 in lieu of payment for services (2017-11-13)
|
|
|
875,000
|
|
|
|
140,000
|
|
Cancellation pursuant to annual general meeting (2017-11-24)
|
|
|
(2,000,000
|
)
|
|
|
—
|
|
Issue at A$0.39 pursuant to placement (2018-03-15)
|
|
|
13,162,744
|
|
|
|
5,161,585
|
|
Issue at A$0.32 on exercise of IMRNW warrants (2018-03-15)
|
|
|
300,000
|
|
|
|
95,282
|
|
Less: Transaction costs arising on share issues
|
|
|
—
|
|
|
|
(733,152
|
)
|
Balance at 30 June 2018
|
|
|
142,778,206
|
|
|
|
58,372,043
|
|
Issue at A$0.16 in lieu of payment for services
(2018-11-22)3
|
|
|
437,500
|
|
|
|
70,000
|
|
Issue at US$0.10 pursuant to ADS public offering
(2019-05-30)4
|
|
|
20,000,000
|
|
|
|
2,894,238
|
|
Reclassify exercised options from reserves to share capital
|
|
|
—
|
|
|
|
100
|
|
Less: Transaction costs arising on share issues
|
|
|
—
|
|
|
|
(825,055
|
)
|
Balance at 30 June 2019
|
|
|
163,215,706
|
|
|
|
60,511,326
|
|
Notes
|
1.
|
As at
30 June 2016, the Company was committed to issue 18,045,512 of ordinary shares in relation
to the A$4,511,378 received in capital raising. These shares were subsequently issued
to respective holders on 7 July 2016. 2,418,129 of these new fully paid ordinary shares
were issued to Grandlodge on the same terms and conditions as all other subscribers.
|
|
2.
|
Grandlodge
participated in our NASDAQ IPO and acquired 32,707 ADRs and 32,707 Warrants.
|
|
3.
|
Mr Peter
and Mr Stephen Anastasiou are directors and majority shareholders of Grandlodge Capital
Pty Ltd (Grandlodge). Commencing 1 June 2013, Immuron Limited contracted Grandlodge on
normal commercial terms and conditions to provide warehousing, distribution and invoicing
services for Immuron Limited’s products for $70,000 per annum. These fees will be payable
in new fully paid ordinary shares in Immuron Limited at a set price of $0.16 per share,
representing Immuron Limited’s shares price at the commencement of the agreement.
|
|
4.
|
On 30
May 2019, 500,000 American Depository Shares (ADS) were issued at US$4.00 each. Each
ADS is equivalent to 40 ordinary shares, i.e. 20,000,000 at US$0.10 each (A$0.1447).
|
Ordinary shares entitle
the holder to participate in dividends, and to share in the proceeds of winding up the company in proportion to the number of
and amounts paid on the shares held.
On a show of hands every
holder of ordinary shares present at a meeting in person or by proxy, is entitled to one vote, and upon a poll each share is entitled
to one vote.
Ordinary shares have
no par value and the Company does not have a limited amount of authorised capital.
The value of all share based payments
of stock is per the terms of an underlying agreement or based on the fair value of the stock on the date of the transaction.
Note 15. Other reserves
The following table shows a
breakdown of the consolidated statement of financial position line item ‘other reserves’ and the movements in
these reserves during the year. A description of the nature and purpose of each reserve is provided below the table.
|
|
Share-based payments
$
|
|
|
Foreign currency translation
$
|
|
|
Total other reserves
$
|
|
At 1 July 2016
|
|
|
2,132,301
|
|
|
|
(3,735
|
)
|
|
|
2,128,566
|
|
Currency translation differences
|
|
|
-
|
|
|
|
40,017
|
|
|
|
40,017
|
|
Other comprehensive income
|
|
|
-
|
|
|
|
40,017
|
|
|
|
40,017
|
|
Transactions with owners in their capacity as owners
|
|
|
|
|
|
|
|
|
|
|
|
|
Options issued during the year
|
|
|
136,784
|
|
|
|
-
|
|
|
|
136,784
|
|
Granted options to be issued (*)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Expense of vested options
|
|
|
333,950
|
|
|
|
-
|
|
|
|
333,950
|
|
Options lapsed
|
|
|
(168,900
|
)
|
|
|
-
|
|
|
|
(168,900
|
)
|
At 30 June 2017
|
|
|
2,434,135
|
|
|
|
36,282
|
|
|
|
2,470,417
|
|
|
(*)
|
On 9 December 2016, the Company issued 1 million options
exercisable at A$0.50 per option expiring on April 1, 2017 to an employee under the Company’s ESOP following the successful
completion of the related milestone pertaining to a minimum recruitment of 100 patients into the Company’s NASH Phase 2
clinical trial.
|
|
|
Share-based
payments
$
|
|
|
Foreign
currency translation
$
|
|
|
Total
other reserves
$
|
|
At 1 July 2017
|
|
|
2,434,135
|
|
|
|
36,282
|
|
|
|
2,470,417
|
|
Currency translation differences
|
|
|
-
|
|
|
|
(79,599
|
)
|
|
|
(79,599
|
)
|
Other comprehensive income
|
|
|
-
|
|
|
|
(79,599
|
)
|
|
|
(79,599
|
)
|
Transactions with owners in their capacity as owners
|
|
|
|
|
|
|
|
|
|
|
|
|
Options issued during the year
|
|
|
156,392
|
|
|
|
-
|
|
|
|
156,392
|
|
Expense of vested options
|
|
|
59,975
|
|
|
|
-
|
|
|
|
59,975
|
|
Options and warrants lapsed
|
|
|
(463
|
)
|
|
|
-
|
|
|
|
(463
|
)
|
At 30 June 2018
|
|
|
2,650,039
|
|
|
|
(43,317
|
)
|
|
|
2,606,722
|
|
|
|
Share-based
payments
$
|
|
|
Foreign
currency translation
$
|
|
|
Total
other reserves
$
|
|
At 1 July 2018
|
|
|
2,650,039
|
|
|
|
(43,317
|
)
|
|
|
2,606,722
|
|
Currency translation differences
|
|
|
-
|
|
|
|
61,846
|
|
|
|
61,846
|
|
Other comprehensive income
|
|
|
-
|
|
|
|
61,846
|
|
|
|
61,846
|
|
Transactions with owners in their capacity as owners
|
|
|
|
|
|
|
|
|
|
|
|
|
Options and warrants issued/expensed
|
|
|
1,343,500
|
|
|
|
-
|
|
|
|
1,343,500
|
|
Options and warrants exercised
|
|
|
(100
|
)
|
|
|
-
|
|
|
|
(100
|
)
|
Options and warrants lapsed
|
|
|
(311,635
|
)
|
|
|
-
|
|
|
|
(311,635
|
)
|
At 30 June 2019
|
|
|
3,681,804
|
|
|
|
18,529
|
|
|
|
3,700,333
|
|
|
(i)
|
Nature and purpose
of other reserves
|
Share-based payments
The share-based payment reserve records
items recognized as expenses on valuation of share options and warrants issued to key management personnel, other employees and
eligible contractors.
Foreign currency translation
Exchange differences arising on translation
of foreign controlled entities are recognized in other comprehensive income as described in note 1(d) and accumulated in a separate
reserve within equity. The cumulative amount is reclassified to profit or loss when the net investment is disposed of.
|
(ii)
|
Movements in
options and warrants:
|
Details
|
|
Number of
options
|
|
|
Total
$
|
|
Balance
at 1 July 2016
|
|
|
9,937,629
|
|
|
|
2,132,301
|
|
Right issue (2016-07-07)*
|
|
|
18,045,512
|
|
|
|
-
|
|
Right issue (2016-07-07)
|
|
|
3,275,466
|
|
|
|
-
|
|
Right issue to oversubscribes
and private placement (2016-09-29)
|
|
|
3,968,916
|
|
|
|
-
|
|
Unlisted options issued at
A$0.143 in lieu of services (2016-12-09)
|
|
|
200,000
|
|
|
|
28,620
|
|
Options issued at A$0.00033
to cover equivalent of 610,000 warrants on issue with NASDAQ (2017-06-09)
|
|
|
24,400,000
|
|
|
|
8,101
|
|
Options issued at A$0.00033
to cover equivalent of 35,075 warrants on issue with NASDAQ (2017-06-09)
|
|
|
1,403,000
|
|
|
|
463
|
|
Options issued at A$0.00033
to cover equivalent of 91,500 warrants on issue with NASDAQ (2017-06-13)
|
|
|
3,660,000
|
|
|
|
1,215
|
|
Unlisted options issued at
A$0.094 in lieu of services (2017-06-22)
|
|
|
1,050,000
|
|
|
|
98,385
|
|
Lapse of unexercised options
|
|
|
(2,250,000
|
)
|
|
|
(168,900
|
)
|
Expense
of vested options
|
|
|
-
|
|
|
|
333,950
|
|
Balance
at 30 June 2017
|
|
|
63,690,523
|
|
|
|
2,434,135
|
|
Lapse of unlisted options (2017-07-01)
|
|
|
(403,000
|
)
|
|
|
(463
|
)
|
Lapse of unlisted options (2017-11-01)
|
|
|
(62,500
|
)
|
|
|
-
|
|
Issue of unlisted options at
A$0.468 pursuant to placement (2018-03-15)
|
|
|
7,897,647
|
|
|
|
-
|
|
Issue of unlisted options at
A$0.585 to broker for placement (2018-03-15)
|
|
|
526,510
|
|
|
|
156,392
|
|
Exercise of IMRNW warrants
at A$0.32 (2018-03-15)
|
|
|
(300,000
|
)
|
|
|
-
|
|
Amortisation
of share-based payments for options issued in prior periods
|
|
|
-
|
|
|
|
59,975
|
|
Balance
at 30 June 2018
|
|
|
71,349,180
|
|
|
|
2,650,039
|
|
Issue of ESOP unlisted options
at A$0.50 (2018-07-13)
|
|
|
1,300,000
|
|
|
|
204,100
|
|
Issue of ESOP unlisted options
at A$0.50 (2018-11-26)
|
|
|
2,000,000
|
|
|
|
164,400
|
|
Lapse of ESOP unlisted options
at A$0.50 (2018-10-01)
|
|
|
(1,050,000
|
)
|
|
|
(98,385
|
)
|
Issue of ESOP unlisted options
at A$0.50 (2019-02-11)
|
|
|
5,000,000
|
|
|
|
975,000
|
|
Lapse of unlisted options at
A$0.57 (2019-02-24)
|
|
|
(1,000,000
|
)
|
|
|
(185,601
|
)
|
Lapse of unlisted options at
A$1.892 (2019-02-28)
|
|
|
(15,380
|
)
|
|
|
(1,173
|
)
|
Lapse of unlisted options at
A$0.30 (2019-05-28)
|
|
|
(140,056
|
)
|
|
|
(13,390
|
)
|
Reclassify exercised options
from reserves to share capital
|
|
|
-
|
|
|
|
(100
|
)
|
Reclassify
lapsed options from reserves to accumulated losses
|
|
|
-
|
|
|
|
(13,086
|
)
|
Balance
at 30 June 2019
|
|
|
77,443,744
|
|
|
|
3,681,804
|
|
|
(*)
|
As of 30 June 2016, the Company was committed to issue
18,045,512 options in relation to the A$4,511,378 received in capital raising. These options were subsequently issued to respective
holders on 7 July 2016. 2,418,129 of these options were issued to Grandlodge on the same terms and conditions as all other subscribers.
|
On 22 June 2017, the Company issued Professor Ravi Savarirayan, a Non-Executive Director of Immuron Limited,
1,000,000 unlisted options exercisable at A$0.50 on or before 27 Nov 2019. During the 2018 annual general meeting, the shareholders
approved the issuance of the options to Ravi Savarirayan.
On 13 July 2018, the Company issued Professor
Dr. Jerry Kanellos, Chief Operating Officer of Immuron Limited, 1,000,000 unlisted options exercisable at A$0.50 on or before
1 July 2021.
On 26 November 2018, the Company issued
Mr. Richard J. Berman, a Non-Executive Director of Immuron Limited, 2,000,000 unlisted options exercisable at A$0.50 on or before
30 June 2020. During the 2019 annual general meeting, the shareholders approved the issuance of the options to Richard Berman.
On 11 February 2019, the Company issued
Dr. Gary S. Jacob, Chief Executive Officer and an Executive Director of Immuron Limited, 5,000,000 unlisted options exercisable
at A$0.50 on or before 10 February 2024. These options are currently held in escrow and cannot be exercised until shareholder
approval is granted.
Note 16. Segment Reporting
Description of segments and principal
activities
The group has identified its operating
segments based on the internal reports that are reviewed and used by the executive management team in assessing performance and
determining the allocation of resources.
Management considers the business from
both a product and a geographic perspective and has identified two reportable segments:
Research and development (R&D): income
and expenses directly attributable to the group’s R&D projects performed in Australia, Israel and United States.
Hyperimmune products: income and expenses directly
attributable to Travelan and Protectyn activities which occur in Australia, the United States, Canada and the rest of the world.
Financial breakdown
The segment information for the reportable
segments for the year ended 30 June 2019 is as follows:
2019
|
|
Research
and development
|
|
|
Hyperimmune
products
|
|
|
Unallocated
|
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Revenue from contracts with customers
|
|
|
-
|
|
|
|
2,387,426
|
|
|
|
-
|
|
|
|
2,387,426
|
|
Cost of sales of goods
|
|
|
-
|
|
|
|
(667,371
|
)
|
|
|
-
|
|
|
|
(667,371
|
)
|
Gross profit
|
|
|
-
|
|
|
|
1,720,055
|
|
|
|
-
|
|
|
|
1,720,055
|
|
Other income
|
|
|
531,005
|
|
|
|
1,045
|
|
|
|
-
|
|
|
|
532,050
|
|
Other gains/(losses) – net
|
|
|
-
|
|
|
|
(13,394
|
)
|
|
|
51,807
|
|
|
|
38,413
|
|
General and administrative expenses
|
|
|
-
|
|
|
|
-
|
|
|
|
(5,014,128
|
)
|
|
|
(5,014,128
|
)
|
Research and development expenses
|
|
|
(1,044,528
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,044,528
|
)
|
Selling and marketing expenses
|
|
|
-
|
|
|
|
(864,644
|
)
|
|
|
-
|
|
|
|
(864,644
|
)
|
Operating profit/(loss)
|
|
|
(513,523
|
)
|
|
|
843,062
|
|
|
|
(4,962,321
|
)
|
|
|
(4,632,782
|
)
|
Finance income
|
|
|
-
|
|
|
|
-
|
|
|
|
39
|
|
|
|
39
|
|
Profit/(loss) for the year
|
|
|
(513,523
|
)
|
|
|
843,062
|
|
|
|
(4,962,282
|
)
|
|
|
(4,632,743
|
)
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment assets
|
|
|
531,828
|
|
|
|
2,705,330
|
|
|
|
5,324,489
|
|
|
|
8,561,647
|
|
Total assets
|
|
|
531,828
|
|
|
|
2,705,330
|
|
|
|
5,324,489
|
|
|
|
8,561,647
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment liabilities
|
|
|
221,520
|
|
|
|
191,836
|
|
|
|
797,155
|
|
|
|
1,210,511
|
|
Total liabilities
|
|
|
221,520
|
|
|
|
191,836
|
|
|
|
797,155
|
|
|
|
1,210,511
|
|
The segment information for the reportable
segments for the year ended 30 June 2018 is as follows:
2018
|
|
Research
and development
|
|
|
Hyperimmune
products
|
|
|
Unallocated
|
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Revenue from contracts with customers
|
|
|
-
|
|
|
|
1,842,909
|
|
|
|
-
|
|
|
|
1,842,909
|
|
Cost of sales of goods
|
|
|
-
|
|
|
|
(418,693
|
)
|
|
|
-
|
|
|
|
(418,693
|
)
|
Gross profit
|
|
|
-
|
|
|
|
1,424,216
|
|
|
|
-
|
|
|
|
1,424,216
|
|
Other income
|
|
|
1,849,123
|
|
|
|
40
|
|
|
|
-
|
|
|
|
1,849,163
|
|
Other gains/(losses) – net
|
|
|
-
|
|
|
|
(163,600
|
)
|
|
|
258,767
|
|
|
|
95,167
|
|
General and administrative expenses
|
|
|
-
|
|
|
|
-
|
|
|
|
(3,412,576
|
)
|
|
|
(3,412,576
|
)
|
Research and development expenses
|
|
|
(2,257,224
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,257,224
|
)
|
Selling and marketing expenses
|
|
|
-
|
|
|
|
(686,714
|
)
|
|
|
-
|
|
|
|
(686,714
|
)
|
Operating profit/(loss)
|
|
|
(408,101
|
)
|
|
|
573,942
|
|
|
|
(3,153,809
|
)
|
|
|
(2,987,968
|
)
|
Finance income
|
|
|
-
|
|
|
|
-
|
|
|
|
1,238
|
|
|
|
1,238
|
|
Finance costs
|
|
|
-
|
|
|
|
-
|
|
|
|
(24,199
|
)
|
|
|
(24,199
|
)
|
Profit/(loss) for the year
|
|
|
(408,101
|
)
|
|
|
573,942
|
|
|
|
(3,176,770
|
)
|
|
|
(3,010,929
|
)
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment assets
|
|
|
1,191,029
|
|
|
|
3,162,045
|
|
|
|
4,889,614
|
|
|
|
9,242,688
|
|
Total assets
|
|
|
1,191,029
|
|
|
|
3,162,045
|
|
|
|
4,889,614
|
|
|
|
9,242,688
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment liabilities
|
|
|
174,434
|
|
|
|
26,009
|
|
|
|
602,895
|
|
|
|
803,338
|
|
Total liabilities
|
|
|
174,434
|
|
|
|
26,009
|
|
|
|
602,895
|
|
|
|
803,338
|
|
The segment information for the reportable
segments for the year ended 30 June 2017 is as follows:
2017
|
|
Research and development
|
|
|
Hyperimmune products
|
|
|
Unallocated
|
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Revenue from contracts with customers
|
|
|
-
|
|
|
|
1,396,197
|
|
|
|
-
|
|
|
|
1,396,197
|
|
Cost of sales of goods
|
|
|
-
|
|
|
|
(337,546
|
)
|
|
|
-
|
|
|
|
(337,546
|
)
|
Gross profit
|
|
|
-
|
|
|
|
1,058,651
|
|
|
|
-
|
|
|
|
1,058,651
|
|
Other income
|
|
|
1,600,315
|
|
|
|
5,672
|
|
|
|
-
|
|
|
|
1,605,987
|
|
Other gains/(losses) – net
|
|
|
-
|
|
|
|
(136,494
|
)
|
|
|
(238,985
|
)
|
|
|
(375,479
|
)
|
General and administrative expenses
|
|
|
-
|
|
|
|
-
|
|
|
|
(3,109,845
|
)
|
|
|
(3,109,845
|
)
|
Research and development expenses
|
|
|
(4,630,674
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
(4,630,674
|
)
|
Selling and marketing expenses
|
|
|
-
|
|
|
|
(543,129
|
)
|
|
|
(728,397
|
)
|
|
|
(1,271,526
|
)
|
Operating profit/(loss)
|
|
|
(3,030,359
|
)
|
|
|
384,700
|
|
|
|
(4,077,227
|
)
|
|
|
(6,722,886
|
)
|
Finance income
|
|
|
-
|
|
|
|
-
|
|
|
|
8,386
|
|
|
|
8,386
|
|
Finance costs
|
|
|
-
|
|
|
|
-
|
|
|
|
(89,654
|
)
|
|
|
(89,654
|
)
|
Profit/(loss) for the year
|
|
|
(3,030,359
|
)
|
|
|
384,700
|
|
|
|
(4,158,495
|
)
|
|
|
(6,804,154
|
)
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment assets
|
|
|
1,498,112
|
|
|
|
2,585,755
|
|
|
|
4,202,624
|
|
|
|
8,286,491
|
|
Total assets
|
|
|
1,498,112
|
|
|
|
2,585,755
|
|
|
|
4,202,624
|
|
|
|
8,286,491
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment liabilities
|
|
|
514,326
|
|
|
|
330,218
|
|
|
|
867,021
|
|
|
|
1,711,565
|
|
Total liabilities
|
|
|
514,326
|
|
|
|
330,218
|
|
|
|
867,021
|
|
|
|
1,711,565
|
|
Information on geographical regions:
The group derives revenue from the transfer of hyperimmune
products at a point in time in the following major product lines and geographical regions:
|
|
Travelan
|
|
|
Protectyn
|
|
|
|
|
2019
|
|
Australia
|
|
|
United
States
|
|
|
Other
|
|
|
Australia
|
|
|
Other
|
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Segment
revenue
|
|
|
1,162,628
|
|
|
|
1,016,468
|
|
|
|
149,283
|
|
|
|
58,683
|
|
|
|
364
|
|
|
|
2,387,426
|
|
Revenue
from external customers
|
|
|
1,162,628
|
|
|
|
1,016,468
|
|
|
|
149,283
|
|
|
|
58,683
|
|
|
|
364
|
|
|
|
2,387,426
|
|
|
|
Travelan
|
|
|
Protectyn
|
|
|
|
|
2018
|
|
Australia
|
|
|
United States
|
|
|
Other
|
|
|
Australia
|
|
|
Other
|
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Segment revenue
|
|
|
1,042,279
|
|
|
|
767,354
|
|
|
|
2,095
|
|
|
|
30,319
|
|
|
|
862
|
|
|
|
1,842,909
|
|
Revenue from external customers
|
|
|
1,042,279
|
|
|
|
767,354
|
|
|
|
2,095
|
|
|
|
30,319
|
|
|
|
862
|
|
|
|
1,842,909
|
|
In 2017, the Company earned 64%, 26% and 10% of its revenues
from customers located in Australia, United States and Canada, respectively.
Information on major customers:
During the years ended 30 June 2019, 2018
and 2017, the Company had the following major customers in the hyperimmune product segment with revenues amounting to 10 percent
or more of total group revenues:
|
|
2019
|
|
|
2018
|
|
Customer A
|
|
|
659,637
|
|
|
|
609,305
|
|
Customer B
|
|
|
611,920
|
|
|
|
435,763
|
|
Customer C
|
|
|
266,111
|
|
|
|
-
|
|
Customer D
|
|
|
249,522
|
|
|
|
193,627
|
|
Customer E
|
|
|
228,661
|
|
|
|
218,216
|
|
|
|
|
2,015,851
|
|
|
|
1,456,911
|
|
|
|
2017
|
|
Customer A
|
|
|
13
|
%
|
Customer B
|
|
|
34
|
%
|
Customer C
|
|
|
15
|
%
|
Customer D
|
|
|
15
|
%
|
Customer E
|
|
|
10
|
%
|
No other single customers contributed
10% or more to the Group’s revenue for all periods.
Note 17. Cash Flow Information
|
(a)
|
Reconciliation
of cash flow from operations with loss after income tax
|
|
|
30 June
2019
AUD$
|
|
|
30 June
2018
AUD$
|
|
|
30 June
2017
AUD$
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the Year
|
|
|
(4,632,743
|
)
|
|
|
(3,010,929
|
)
|
|
|
(6,804,154
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments for
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense
|
|
|
5,287
|
|
|
|
5,047
|
|
|
|
4,922
|
|
Interest accrued on borrowings
|
|
|
—
|
|
|
|
—
|
|
|
|
8,561
|
|
Distribution costs
|
|
|
70,000
|
|
|
|
—
|
|
|
|
—
|
|
Expected credit losses
|
|
|
34,046
|
|
|
|
—
|
|
|
|
—
|
|
Finance costs
|
|
|
—
|
|
|
|
24,199
|
|
|
|
97,051
|
|
Finance income
|
|
|
(39
|
)
|
|
|
(1,238
|
)
|
|
|
(8,386
|
)
|
Leave provision expense
|
|
|
4,580
|
|
|
|
41,110
|
|
|
|
5,902
|
|
Share-based payments
|
|
|
1,343,500
|
|
|
|
242,950
|
|
|
|
522,665
|
|
Unrealised net foreign currency (gains)/losses
|
|
|
(62,015
|
)
|
|
|
(316,380
|
)
|
|
|
24,433
|
|
Change in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Add decreases / (increases) in trade and other receivables
|
|
|
680,337
|
|
|
|
438,001
|
|
|
|
7,396
|
|
Add decreases / (increases) in inventories
|
|
|
263,365
|
|
|
|
(333,642
|
)
|
|
|
(280,060
|
)
|
Add (increases) in other operating assets
|
|
|
92,510
|
|
|
|
26,561
|
|
|
|
69,034
|
|
Add (decrease) / increase in trade and other payables
|
|
|
402,593
|
|
|
|
(620,202
|
)
|
|
|
(589,787
|
)
|
|
|
|
(1,798,579
|
)
|
|
|
(3,504,523
|
)
|
|
|
(6,942,423
|
)
|
|
(b)
|
Non-cash financing
and investing activities
|
The Company financed A$162,457 for
its insurance policies during the year ended June 30, 2017, which was recorded to Borrowings and Other Assets as of June 30, 2017.
During the financial year 2018, the balance
of the outstanding convertible note as at 30 June 2017 was repaid during July 2017 and August 2017 with the liability being fully
extinguished by 10 September 2017.
See note 18 for details regarding issues
of options to employees and for details surrounding the issue of shares to suppliers.
Note 18. Share-based Payments
|
a)
|
Executive
share and option plan
|
The establishment of the ‘executive share
and option plan’ (ESOP) was approved by shareholders at the 2017 annual general meeting. The plan is designed to provide long-term
incentives for executives (including directors) to deliver long-term shareholder returns. Participation in the plan is at the
board’s discretion and no individual has a contractual right to participate in the plan or to receive any guaranteed benefits.
Options issued to Dr Gary Jacob expire
upon his resignation without good reason or termination. All other options issued expire upon departure from the company if they
are determined to be a ‘bad leaver’.
Set out below are summaries of all listed
and unlisted options, including those issued under ESOP:
|
|
2019
|
|
|
2018
|
|
|
2017
|
|
|
|
Average exercise
price per share option
|
|
|
Number of
options
|
|
|
Average exercise
price per share option
|
|
|
Number of
options
|
|
|
Average exercise
price per share option
|
|
|
Number of
options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As at 1 July
|
|
$
|
0.45
|
|
|
|
71,349,180
|
|
|
$
|
0.44
|
|
|
|
63,690,523
|
|
|
$
|
0.60
|
|
|
|
9,937,629
|
|
Granted during the year
|
|
$
|
0.50
|
|
|
|
8,300,000
|
|
|
$
|
0.48
|
|
|
|
8,424,157
|
|
|
$
|
0.43
|
|
|
|
56,002,894
|
|
Exercised during the year
|
|
|
—
|
|
|
|
—
|
|
|
$
|
0.32
|
|
|
|
(300,000
|
)
|
|
|
—
|
|
|
|
—
|
|
Forfeited/lapsed
during the year
|
|
$
|
0.53
|
|
|
|
(2,205,436
|
)
|
|
$
|
0.49
|
|
|
|
(465,500
|
)
|
|
$
|
0.48
|
|
|
|
(2,250,000
|
)
|
As at
30 June
|
|
$
|
0.42
|
|
|
|
77,443,744
|
|
|
$
|
0.45
|
|
|
|
71,349,180
|
|
|
$
|
0.44
|
|
|
|
63,690,523
|
|
Vested and exercisable at 30
June
|
|
$
|
0.42
|
|
|
|
77,443,744
|
|
|
$
|
0.45
|
|
|
|
71,349,180
|
|
|
$
|
0.44
|
|
|
|
62,690,523
|
|
Share
options outstanding at the end of the year have the following expiry date and exercise prices:
ASX new issue
announcement date (Appendix 3B)
|
|
Expiry date
|
|
Exercise
price
($)
|
|
|
Share options
30 June 2019
|
|
|
Share options
30 June 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2012-06-29
|
|
2021-11-30
|
|
|
1.944
|
|
|
|
14,493
|
|
|
|
14,493
|
|
2012-06-29
|
|
2022-01-17
|
|
|
1.876
|
|
|
|
29,668
|
|
|
|
29,668
|
|
2014-03-03
|
|
2019-02-28
|
|
|
1.892
|
|
|
|
-
|
|
|
|
15,380
|
|
2015-05-27
|
|
2019-11-27
|
|
|
0.500
|
|
|
|
6,000,000
|
|
|
|
6,000,000
|
|
2016-05-31
|
|
2019-11-27
|
|
|
0.500
|
|
|
|
425,532
|
|
|
|
425,532
|
|
2016-12-09
|
|
2019-11-27
|
|
|
0.500
|
|
|
|
200,000
|
|
|
|
200,000
|
|
2017-06-22
|
|
2019-11-27
|
|
|
0.500
|
|
|
|
1,000,000
|
|
|
|
1,000,000
|
|
2014-05-29
|
|
2019-05-28
|
|
|
0.300
|
|
|
|
-
|
|
|
|
140,056
|
|
2016-02-18
|
|
2019-02-24
|
|
|
0.570
|
|
|
|
-
|
|
|
|
1,000,000
|
|
2016-12-02 (IMCOB)
|
|
2019-11-30
|
|
|
0.550
|
|
|
|
25,289,894
|
|
|
|
25,289,894
|
|
2017-06-13 (warrants)
|
|
2022-06-13
|
|
|
USD 0.25
|
|
|
|
27,760,000
|
|
|
|
27,760,000
|
|
2017-06-22
|
|
2018-10-01
|
|
|
0.500
|
|
|
|
-
|
|
|
|
1,050,000
|
|
2018-03-15
|
|
2023-03-15
|
|
|
0.468
|
|
|
|
7,897,647
|
|
|
|
7,897,647
|
|
2018-03-15
|
|
2023-03-15
|
|
|
0.585
|
|
|
|
526,510
|
|
|
|
526,510
|
|
2018-07-13
|
|
2021-07-01
|
|
|
0.500
|
|
|
|
1,300,000
|
|
|
|
-
|
|
2018-11-26
|
|
2020-06-30
|
|
|
0.500
|
|
|
|
2,000,000
|
|
|
|
-
|
|
2019-02-11
|
|
2024-02-10
|
|
|
0.500
|
|
|
|
5,000,000
|
|
|
|
-
|
|
Total
|
|
|
|
|
|
|
|
|
77,443,744
|
|
|
|
71,349,180
|
|
|
●
|
Warrants
are exercisable at US$10.00 per 40 options, i.e. US$0.25 per option.
|
Weighted average remaining contractual life of options outstanding at end of period
|
|
|
2.00
|
|
|
|
2.77
|
|
(i)
Fair value of options granted
The
assessed fair value of options at grant date was determined using the Black-Scholes option pricing model that takes into account
the exercise price, term of the option, security price at grant date and expected price volatility of the underlying security,
the expected dividend yield, the risk-free interest rate for the term of the security and certain probability assumptions.
The
model inputs for options granted under ESOP during the year ended 30 June 2019 included:
Grant date
|
|
Expiry date
|
|
Exercise price ($)
|
|
|
No. of options
|
|
|
Share price at grant date ($)
|
|
|
Expected volatility
|
|
|
Dividend yield
|
|
|
Risk- free interest rate
|
|
|
Fair value at grant date per option ($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2018-07-13
|
|
2021-07-01
|
|
|
0.50
|
|
|
|
1,300,000
|
|
|
|
0.32
|
|
|
|
92.00
|
%
|
|
|
0.00
|
%
|
|
|
2.09
|
%
|
|
|
0.1570
|
|
2018-11-26
|
|
2020-06-30
|
|
|
0.50
|
|
|
|
2,000,000
|
|
|
|
0.34
|
|
|
|
92.00
|
%
|
|
|
0.00
|
%
|
|
|
2.02
|
%
|
|
|
0.0822
|
|
2019-02-11
|
|
2024-02-11
|
|
|
0.50
|
|
|
|
5,000,000
|
|
|
|
0.29
|
|
|
|
100.00
|
%
|
|
|
0.00
|
%
|
|
|
1.69
|
%
|
|
|
0.1950
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,300,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 2016 Options
Pursuant to an agreement entered
between the Company and a consultant on April 1, 2015, the Company granted 1,000,000 options, which were issued and vested on 9
December 2016, and each option entitles the holder to purchase one ordinary share of the Company at an exercise price of A$0.500.
These options were issued and vested following the successful completion of related milestone pertaining to a minimum recruitment
of 100 patients into the Company’s NASH Phase 2 clinical trial.
The following table lists the inputs to the model
used to determine the weighted average value of the options expensed during the year:
Vesting date
|
|
|
|
|
N/A
|
|
Dividend yield
|
|
|
|
|
|
|
—
|
|
Expected volatility
|
|
|
|
|
|
|
100
|
%
|
Risk-free interest rate
|
|
|
|
|
|
|
1.69
|
%
|
Expected life of option (years)
|
|
|
|
|
|
|
3.17 years
|
|
Option exercise price
|
|
|
AUD$
|
|
|
|
0.5000
|
|
Weighted average share price at grant date
|
|
|
AUD$
|
|
|
|
0.285
|
|
Value per option
|
|
|
AUD$
|
|
|
|
0.1431
|
|
June 2017 Options
The following table lists the inputs to the model
used to determine the weighted average value of the options expensed during the year:
Vesting date
|
|
|
|
|
|
|
N/A
|
|
Dividend yield
|
|
|
|
|
|
|
—
|
|
Expected volatility
|
|
|
|
|
|
|
100
|
%
|
Risk-free interest rate
|
|
|
|
|
|
|
1.69
|
%
|
Expected life of option (years)
|
|
|
|
|
|
|
1.33 years
|
|
Option exercise price
|
|
|
AUD$
|
|
|
|
0.5000
|
|
Weighted average share price at grant date
|
|
|
AUD$
|
|
|
|
0.315
|
|
Value per option
|
|
|
AUD$
|
|
|
|
0.0937
|
|
The expected life of the options
is based on historical data and is not necessarily indicative of exercise patterns that may occur. The expected volatility reflects
the assumption that the historical volatility is indicative of future trends, which may also not necessarily be the actual outcome.
|
b)
|
Expenses
arising from share-based payment transactions
|
Total
expenses arising from share-based payment transactions recognized during the period were as follows:
|
|
2019
$
|
|
|
2018
$
|
|
|
2017
$
|
|
Options issued under ESOP
|
|
|
1,343,500
|
|
|
|
59,975
|
|
|
|
522,665
|
|
Note
19. Related Party Transactions
Interests
in subsidiaries are set out in note 10.
|
(b)
|
Transactions
with other related parties
|
The
following transactions occurred with related parties:
|
|
2019
$
|
|
|
2018
$
|
|
|
2017
$
|
|
|
|
|
|
|
|
|
|
|
|
Amounts settled in cash or shares for goods and services
|
|
|
|
|
|
|
|
|
|
Purchases of various goods and services from entities controlled by key management personnel (i)
|
|
|
123,958
|
|
|
|
173,020
|
|
|
|
35,792
|
|
(i)
Purchases from entities controlled by key management personnel
The
group acquired the following goods and services from entities that are controlled by members of the group’s key management personnel:
|
●
|
rental
of an office suite (Wattle Laboratories Pty Ltd); and
|
Effective January 2016, we
executed a Lease Agreement with Wattle Laboratories Pty Ltd, (“Wattle”), an entity part-owned and operated by our
non-executive directors, Peter Anastasiou and Stephen Anastasiou, whereby we lease part of their Blackburn office facilities for
our operations at a rental rate of A$38,940 per year, payable in monthly installments. The rental agreement is subject to annual
rental increases, and effective January 2017, the annual rent was increased to A$39,525. The lease is for a three year term with
an additional three year option period. The lease may be terminated by either party upon six months’ written notice. During
the fiscal years ended June 30, 2017, 2018 and 2019, we paid Wattle A$35,792, A$30,019 and A$53,958 (excluding Goods and Services
Tax), respectively. The lease was renewed, commencing January 1, 2019 for three years.
|
●
|
warehousing,
distribution and invoicing services (Grandlodge Capital Pty Ltd).
|
Grandlodge Capital Pty Ltd is an entity
part-owned and operated by our non-executive directors Peter Anastasiou and Stephen Anastasiou. Mr. David Plush is also an owner
of Grandlodge, and its associated entities.
Starting June 1, 2013, Grandlodge provides
warehousing, distribution and invoicing services for our products for A$70,000 per year. During the 2019 financial year, the fees
of A$70,000 equivalent were repaid by issuance of 437,500 ordinary shares based on a price of A$0.16 per share representing the
share price of our ordinary shares at the commencement date of an oral agreement between us and Grandlodge. During the 2018 financial
year, the fees of A$140,000 equivalent were repaid by issuance of 875,000 ordinary shares based on a set price of A$0.16 per share
representing the share price of our ordinary shares at the commencement date of an oral agreement between us and Grandlodge. The
875,000 shares issued to Grandlodge were in relation to the 2017 and 2018 financial years.
Grandlodge is reimbursed in cash for all
reasonable costs and expenses incurred in accordance with their scope of works under the oral agreement, unless both Grandlodge
and we agree to an alternative method of payment. The oral agreement may be terminated by either party upon providing the other
party with 30 days written notice of the termination of the agreement.
Aggregate
amounts of each of the above types of other transactions with key management personnel of Immuron Limited:
|
|
2019
$
|
|
|
2018
$
|
|
|
2017
$
|
|
Amounts settled in cash or shares during the period
|
|
|
|
|
|
|
|
|
|
Rental of an office suite from Wattle Laboratories Pty Ltd
|
|
|
53,958
|
|
|
|
33,020
|
|
|
|
35,792
|
|
Services rendered by Grandlodge Capital Pty Ltd
|
|
|
70,000
|
|
|
|
140,000
|
|
|
|
-
|
|
|
|
|
123,958
|
|
|
|
173,020
|
|
|
|
35,792
|
|
|
(c)
|
Outstanding
balances arising from sales/purchases of goods and services
|
The
following balances are outstanding at the end of the reporting period in relation to transactions with related parties:
|
|
2019
$
|
|
|
2018
$
|
|
|
2017
$
|
|
Current payables (purchases of goods and services)
|
|
|
|
|
|
|
|
|
|
Entities controlled by key management personnel
|
|
|
-
|
|
|
|
35,000
|
|
|
|
105,000
|
|
|
(d)
|
Loans
to/from related parties
|
|
|
2019$
|
|
|
2018$
|
|
|
2017$
|
|
Loans from key management personnel
|
|
|
|
|
|
|
|
|
|
Beginning of the year
|
|
|
-
|
|
|
|
-
|
|
|
|
772,397
|
|
Loans advanced
|
|
|
-
|
|
|
|
500,000
|
|
|
|
500,000
|
|
Loans repayments made
|
|
|
-
|
|
|
|
(500,000
|
)
|
|
|
(1,250,000
|
)
|
Fees and interest charged
|
|
|
-
|
|
|
|
20,342
|
|
|
|
56,610
|
|
Fees and interest paid
|
|
|
-
|
|
|
|
(20,342
|
)
|
|
|
(79,007
|
)
|
End of year
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Terms
and conditions:
During
the year ended 30 June 2018, the group entered into a short-term loan arrangement for an amount of $500,000 with Great Accommodation
Pty Ltd, an entity controlled by Mr Daniel Pollock. The purpose of this loan was to fund on going R&D expenditure. Interest
accrued at a rate of 15% per annum in addition to a $15,000 establishment fee. The loan was repaid in full on 12 February 2018.
Grandlodge Capital Pty Ltd (Grandlodge)
is an entity part-owned and operated by Immuron Directors Peter and Stephen Anastasiou. Mr David Plush is also an owner of Grandlodge,
and its associated entities. On 6 June 2016 and 9 May 2017, Immuron executed a short-term funding agreement with Grandlodge for
a principle amount of $750,000 (interest rate 15%) and $500,000 (interest rate 15%) respectively. The short-term funding is a cash
advance against the anticipated refund Immuron will receive from the Australian Taxation Office under the Research and Development
Income Tax Concession Incentive for the group’s eligible R&D expenditure incurred for financial year of 2016 and 2017.
Interest expense was approximately $57,000 for the years ended 30 June 2017. Loan from June 2016 and May 2017, plus applicable
fees and interest, was repaid to Grandlodge on 2 December 2016 and 23 June 2017, respectively.
Note
20. Financial Risk Management Objectives and Policies
This
note explains the Group’s exposure to financial risks and how these risks could affect the Group’s future financial performance.
The
Group’s risk management is predominantly controlled by the Board. The Board monitors the Group’s financial risk management
policies and exposures and approves substantial financial transactions. It also reviews the effectiveness of internal controls
relating to market risk, credit risk and liquidity risk.
Risk Management Policy
The Board is responsible for overseeing the establishment
and implementation of the risk management system, and reviews and assesses the effectiveness of the Company’s implementation
of that system on a regular basis.
The Board and Senior Management identify the general
areas of risk and their impact on the activities of the Company, with Management performing a regular review of:
|
Ø
|
the major risks that occur within the business; the degree
of risk involved;
|
|
Ø
|
the current approach to managing the risk; and
|
|
Ø
|
if appropriate, determine:
|
|
○
|
any inadequacies of the current approach; and
|
|
○
|
possible new approaches that more efficiently and effectively address the risk.
|
Management report risks identified to the Board through the
monthly Operations Report.
The Company seeks to ensure that its exposure to
undue risk which is likely to impact its financial performance, continued growth and survival is minimised in a cost effective
manner.
(a)
Market risk
(i)
Foreign exchange risk
The
Group undertakes certain transactions denominated in foreign currency and is exposed to foreign currency risk through foreign
exchange rate fluctuations.
Foreign
exchange rate risk arises from financial assets and financial liabilities denominated in a currency that is not the Group’s functional
currency. Exposure to foreign currency risk may result in the fair value of future cash flows of a financial instrument fluctuating
due to the movement in foreign exchange rates of currencies in which the group holds financial instruments which are other than
the Australian dollar (AUD) functional currency of the Group. This risk is measured using sensitivity analysis and cash flow forecasting.
The cost of hedging at this time outweighs any benefits that may be obtained.
Exposure
The
Group’s exposure to foreign currency risk at the end of the reporting period, expressed in Australian dollars, was as follows:
|
|
2019
|
|
|
2018
|
|
|
|
USD
$
|
|
|
CAD
$
|
|
|
ILS
$
|
|
|
USD
$
|
|
|
CAD
$
|
|
|
ILS
$
|
|
Cash and cash equivalents
|
|
|
4,852,834
|
|
|
|
22,801
|
|
|
|
-
|
|
|
|
4,222,310
|
|
|
|
-
|
|
|
|
-
|
|
Trade receivables
|
|
|
157,451
|
|
|
|
-
|
|
|
|
-
|
|
|
|
158,978
|
|
|
|
-
|
|
|
|
-
|
|
Trade payables
|
|
|
245,284
|
|
|
|
-
|
|
|
|
13,657
|
|
|
|
45,018
|
|
|
|
10,278
|
|
|
|
4,320
|
|
Total exposure
|
|
|
5,255,569
|
|
|
|
22,801
|
|
|
|
13,657
|
|
|
|
4,426,306
|
|
|
|
10,278
|
|
|
|
4,320
|
|
Sensitivity
As
shown in the table above, the Group is primarily exposed to changes in USD/AUD exchange rates. The sensitivity of profit or loss
to changes in the exchange rates arises mainly from USD denominated financial instruments. The impact on other components of equity
arises from the translation of foreign subsidiary financial statements into AUD.
The
Group has conducted a sensitivity analysis of its exposure to foreign currency risk. The Group is currently materially exposed
to the United States dollar (USD). The sensitivity analysis is conducted on a currency-by-currency basis using the sensitivity
analysis variable, which is based on the average annual movement in exchange rates over the past five years at year-end spot rates.
The variable for each currency the group is materially exposed to is listed below:
|
|
Impact on loss for the
period
|
|
|
Impact on other components
of equity
|
|
|
|
2019
$
|
|
|
2018
$
|
|
|
2019
$
|
|
|
2018
$
|
|
USD/AUD exchange rate - change by 6.9% (2018: 6.2%)*
|
|
|
362,634
|
|
|
|
274,431
|
|
|
|
1,334
|
|
|
|
2,694
|
|
|
*
|
Holding
all other variables constant
|
Profit
is more sensitive to movements in the AUD/USD exchange rates in 2019 than 2018 because of the increased amount of USD denominated
cash and cash equivalents and the increased variability of the AUD/USD exchange rate. Equity is less sensitive to movements in
the AUD/USD exchange rates in 2019 than 2018 because of the decreased size of the foreign currency translation reserve for the
subsidiary with USD functional currency. The group’s exposure to other foreign exchange movements is not material.
(b)
Credit risk
Exposure
to credit risk relating to financial assets arises from the potential non-performance by counterparties of contract obligations
that could lead to a financial loss to the group.
Credit
risk is managed through the maintenance of procedures (such as the utilisation of systems for the approval, granting and renewal
of credit limits, regular monitoring of exposures against such limits and monitoring the financial stability of significant customers
and counterparties), ensuring to the extent possible that customers and counterparties to transactions are of sound credit worthiness.
Such monitoring is used in assessing receivables for impairment. Credit terms are normally 30 days from the invoice date.
Risk
is also minimised through investing surplus funds in financial institutions that maintain a high credit rating.
For
some trade receivables the group may obtain security in the form of guarantees, deeds of undertaking or letters of credit which
can be called upon if the counterparty is in default under the terms of the agreement.
|
(iii)
|
Impairment
of financial assets
|
The
group has one type of financial asset subject to the expected credit loss model:
|
●
|
trade
receivables for sales of inventory
|
While
cash and cash equivalents are also subject to the impairment requirements of IFRS 9, the identified impairment loss was immaterial.
Trade
receivables
The
group applies the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime expected loss allowance
for all trade receivables.
To
measure the expected credit losses, trade receivables assets have been grouped based on shared credit risk characteristics and
the days past due.
The expected loss rates are based on the
payment profiles of sales over a period of 60 months before June 30, 2019 and the corresponding historical credit losses experienced
within this period. The historical loss rates are adjusted to reflect current and forward-looking information on macroeconomic
factors affecting the ability of the customers to settle the receivables.
On
that basis, the loss allowance as at 30 June 2019 was determined as follows for trade receivables:
|
|
Days past due
|
|
30 June 2019
|
|
Current
$
|
|
|
1-30
$
|
|
|
31-60
$
|
|
|
61-90
$
|
|
|
91-120
$
|
|
|
121+
$
|
|
|
Total
$
|
|
Expected credit loss rate
|
|
|
1.66
|
%
|
|
|
6.19
|
%
|
|
|
18.28
|
%
|
|
|
30.06
|
%
|
|
|
99.78
|
%
|
|
|
91.64
|
%
|
|
|
|
|
Gross carrying amount
|
|
|
209,731
|
|
|
|
83,291
|
|
|
|
15,385
|
|
|
|
416
|
|
|
|
4,307
|
|
|
|
19,842
|
|
|
|
332,972
|
|
Loss allowance
|
|
|
3,476
|
|
|
|
5,153
|
|
|
|
2,813
|
|
|
|
125
|
|
|
|
4,297
|
|
|
|
18,182
|
|
|
|
34,046
|
|
Trade
receivables are written off when there is no reasonable expectation of recovery. Indicators that there is no reasonable expectation
of recovery include, amongst others, the failure of a debtor to engage in a repayment plan with the group, and a failure to make
contractual payments for a period of greater than 121 days past due.
Impairment
losses on trade receivables are presented as net impairment losses within operating profit. Subsequent recoveries of amounts previously
written off are credited against the same line item.
Previous
accounting policy for impairment of trade receivables
In
the prior year, the impairment of trade receivables was assessed based on the incurred loss model. Individual receivables which
were known to be uncollectible were written off by reducing the carrying amount directly. The other receivables were assessed
collectively to determine whether there was objective evidence that an impairment had been incurred but not yet been identified.
For these receivables the estimated impairment losses were recognized in a separate provision for impairment. The Group considered
that there was evidence of impairment if any of the following indicators were present:
|
●
|
significant
financial difficulties of the debtor;
|
|
●
|
probability
that the debtor will enter bankruptcy or financial reorganization; and
|
|
●
|
default
or late payments (more than 121 days overdue).
|
Receivables
for which an impairment provision was recognized were written off against the provision when there was no expectation of recovering
additional cash.
Liquidity
risk arises from the possibility that the group might encounter difficulty in settling its debts or otherwise meeting its obligations
related to financial liabilities. The group manages this risk through the following mechanisms:
|
●
|
preparing
forward looking cash flow analyses in relation to its operating, investing and financing activities;
|
|
●
|
obtaining
funding from a variety of sources;
|
|
●
|
maintaining
a reputable credit profile;
|
|
●
|
managing
credit risk related to financial assets;
|
|
●
|
investing
cash and cash equivalents and deposits at call with major financial institutions; and
|
|
●
|
comparing
the maturity profile of financial liabilities with the realisation profile of financial assets.
|
(i)
Maturities of financial liabilities
The
tables below analyse the group’s financial liabilities into relevant maturity groupings based on their contractual maturities.
The amounts disclosed in the table are the contractual undiscounted cash flows.
|
|
Less than
6 months
|
|
|
6 - 12
months
|
|
|
Between
1 and 2
years
|
|
|
Between
2 and 5
years
|
|
|
Over
5
years
|
|
|
Total
contractual
cash flows
|
|
|
Carrying
amt (assets)/
liabilities
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 30 June 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade and other payables
|
|
|
1,091,919
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,091,919
|
|
|
|
1,091,919
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
1,091,919
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,091,919
|
|
|
|
1,091,919
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 30 June 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade and other payables
|
|
|
689,326
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
689,326
|
|
|
|
689,326
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
689,326
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
689,326
|
|
|
|
689,326
|
|
Note
21. Events occurring after the Reporting Date
On
19 July 2019, the company completed a capital raising comprising 339,130 ADS at US$4.00 per security.
The gross proceeds to the company were US$1,356,520.
On 17 October 2019, Mr Richard Jay Berman resigned as director of the Company effective 17 October 2019.
No
other matter or circumstance has occurred subsequent to period end that has significantly affected, or may significantly affect,
the operations of the group, the results of those operations or the state of affairs of the group or economic entity in subsequent
financial years.
Note
22. Company Details
The
registered office of the Company is:
Level
3, 62 Lygon Street, Carlton, Victoria, Australia 3053.
The principal place of business of the Company is:
Unit
10, 25-37 Chapman Street, Blackburn, Victoria, Australia 3130.