Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, today reported audited financial results for the fourth
quarter and full year ended December 31, 2019 and provided an
update on recent developments in its business.
Keith J. Kendall, Chief Executive Officer of
Aquestive, stated, “Significant advancements have been made across
our portfolio in 2019 and during the first two months of 2020. We
had a constructive pre-IND meeting with the FDA in February 2020
for AQST-108, our “first of its kind” oral sublingual PharmFilm®
formulation delivering systemic epinephrine that is in development
for the treatment of anaphylaxis. Preparations are now underway to
file the IND for AQST-108 during the second quarter 2020 and
commence PK trials by year end. The ability to pursue a
505(b)(2) regulatory approval pathway for this drug candidate will
potentially streamline the development and regulatory process from
both a timeline and cost standpoint. If approved, AQST-108,
as the first highly portable, easy-to-administer and anxiety-free
oral sublingual film medication, is positioned to provide an
innovative and transformative treatment for the underserved
anaphylaxis patient population for whom the current standard of
care is an invasive injection.”
“Following the FDA’s acceptance of our NDA in
February, our drug candidate, Libervant™ (diazepam) Buccal Film,
the first oral diazepam-based therapy for management of seizure
clusters, is advancing through the FDA review process and has been
assigned a September 27, 2020 PDUFA goal date. We believe
that Libervant, if approved by the FDA, will potentially provide a
major contribution to patient care to epilepsy patients who can
benefit from another rescue medication. We look forward to
working with the FDA in the coming months in seeking to demonstrate
that Libervant, as the only orally delivered diazepam-based product
for this indication, has one or more of the attributes required by
the FDA to be considered a “major contribution to patient care,”
within the meaning of FDA regulations and guidance, relative to the
currently approved products. Although FDA approval of Libervant
cannot be assured, we remain committed to helping epilepsy patients
affected by seizure clusters by working to bring important
innovative products to the market.”
Mr. Kendall concluded, “As we focus on these two
important programs we also continue to manage our costs and
streamline our business operations. We have reflected those
efforts on our updated guidance. Based on our planning and
expectations, we anticipate that we will have the cash resources to
take us through early 2021 and, with the expected monetization of
our apomorphine royalty stream, subject to that product being
approved by the FDA, the Company expects to extend that horizon
further.”
Proprietary Pipeline Overview and
Business UpdateAquestive is building a portfolio of
differentiated medicines that can offer physicians and patients,
who have difficulty using currently available treatment options,
improved clinical and usability features based on the Company’s
PharmFilm® technology. The Company’s proprietary products and
late-stage product candidates are initially focused on CNS
conditions and other patient populations with high unmet need.
- At the constructive face-to-face
meeting in February 2020 with the U.S. Food and Drug Administration
(FDA) prior to filing Aquestive’s Investigational New Drug (IND)
application for AQST-108, the FDA confirmed that the drug candidate
will be reviewed under the 505(b)(2) regulatory approval pathway,
and that no additional studies will be necessary prior to opening
the proposed IND application. Aquestive is currently
preparing the IND application, which is expected to be submitted in
the second quarter 2020 and plans to commence PK clinical trials
before year end.
- Following the FDA’s acceptance of
the New Drug Application (NDA) for Aquestive’s drug candidate,
Libervant™ (diazepam) Buccal Film for the management of seizure
clusters, the FDA has assigned a Prescription Drug User Fee Act
(PDUFA) goal date of September 27, 2020. Aquestive believes
that Libervant will, if approved by the FDA, represent a
“major contribution to patient care”, as compared to available
treatment options, and further expand patient choice as the first
orally delivered diazepam-based product available to manage seizure
clusters in epilepsy patients. See an explanation of the
FDA’s determination of “major contribution to patient care” and its
grant of seven-year orphan drug exclusivity for a competing product
in the section below in this press release entitled “Additional
Information Regarding Orphan Drug Exclusivity”.
- Sympazan® (clobazam), an oral film
for the treatment of seizures associated with Lennox-Gastaut
syndrome (LGS) and launched as a precursor and complement to
Libervant, continues to exhibit progress on key performance metrics
including prescriber growth, repeat prescribers, quarterly growth
in retail shipments, and covered lives.
Fourth Quarter 2019
FinancialsTotal revenues were $16.4 million in the fourth
quarter 2019, compared to $16.8 million in the fourth quarter 2018.
This year-over-year decrease reflected lower license fees offset by
higher manufacturing and supply revenue from higher volume and
price on licensee products.
Aquestive’s net loss for the fourth quarter 2019
was $12.6 million, or $0.48 loss per share. The net loss for the
fourth quarter 2018 was $13.9 million, or $0.56 loss per share.
Losses before interest, taxes, depreciation and
amortization, share-based compensation and other adjustments
(adjusted EBITDA losses) were $7.3 million in the fourth quarter of
2019, compared to $10.2 million in the comparable prior
period. The year-over-year change in adjusted EBITDA loss was
driven primarily by lower research and development and selling,
general and administrative expenses, offset partially by higher
manufacturing and supply expenses from higher volume on licensee
products.
Full Year 2019 FinancialsTotal
revenues were $52.6 million, exceeding the top end of the Company’s
guidance range, for the full year 2019, compared to $67.4 million
for the full year 2018. This year-over-year change came primarily
from differences in the magnitude and timing of license and royalty
revenue, as well as co-development and research fees.
The Company’s net loss for the full year 2019
was $66.2 million, or $2.61 loss per share. The net loss for the
full year 2018 was $61.4 million, or $2.96 loss per share.
Adjusted EBITDA losses were $42.7 million in the
full year 2019, better than previously guided, compared to $15.8
million in the full year 2018. The change in adjusted EBITDA
loss was driven by lower revenues, higher investments in the
commercial launch of Sympazan, increased intellectual property
expenses in 2019 related to the generic launch and full-year public
company costs, partially offset by the timing of research and
development expenses.
As of December 31, 2019, cash and cash
equivalents were $49.3 million. In December 2019, the Company
completed a public offering of 8,050,000 shares of common stock for
net proceeds of $37.3 million.
2020 OutlookAquestive’s full year 2020
financial outlook is as follows. The Company expects:
- Total revenues of approximately $35
million to $45 million
- Expected revenue from Suboxone® includes branded only, as
authorized generic products were discontinued in 2019; branded
Suboxone ended 2019 with a 48% film market share and is expected to
continue to erode
- Expected revenues from Sympazan® net sales, co-development
programs, and license fees and royalties from licensed
products
- We did not include any Libervant revenues in our 2020
guidance.
- Non-GAAP adjusted gross margins of
approximately 70% to 75% on total revenues
- Reflective of the anticipated higher profitability of Suboxone
manufacturing revenues and expected greater mix of higher margin
proprietary revenue
- Non-GAAP adjusted EBITDA loss of
approximately $45 million to $50 million
- The Company expects to reduce its expenses and to improve
adjusted EBITDA losses from previous guidance for 2020 by limiting
its near-term focus to Libervant and AQST-108, and managing costs
to reflect the declining revenue of Suboxone and the level of
contribution of Sympazan
- Cash burn of approximately $45
million to $50 million after considering revised adjusted EBITDA
loss guidance, interest, capital spending and working capital
effects, but prior to any additional capital transactions
Tomorrow’s Conference Call and Webcast
ReminderThe management team will host an investment
community conference call tomorrow, March 12, 2020, at 8:00 a.m.
ET. Investors and analysts may participate in the conference
call by dialing (866) 417-5886 from the U.S. and (409) 217-8235
internationally, followed by the conference ID: 3961108.
There will also be a simultaneous, live webcast
available on the Investors section of the Company’s website at
https://investors.aquestive.com/events-and-presentations. The
webcast will be archived for 30 days.
About Aquestive
TherapeuticsAquestive Therapeutics is a pharmaceutical
company that applies innovative technology to solve therapeutic
problems and improve medicines for patients. Aquestive is advancing
proprietary products and late-stage product candidates to treat CNS
conditions and provide alternatives to invasively administered
standard of care therapies. The Company also collaborates with
other pharmaceutical companies to bring new molecules to market
using proprietary, best-in-class technologies, like PharmFilm®, and
has proven capabilities for drug development and
commercialization.
Non-GAAP Financial Information
This press release and our webcast earnings call
regarding our quarterly financial results contains financial
measures that do not comply with U.S. generally accepted accounting
principles (GAAP), such as Adjusted EBITDA, non-GAAP gross margins,
non-GAAP costs and expenses and other adjusted expense measures,
because such measures exclude, as applicable, share-based
compensation, interest expense, interest income, depreciation,
amortization, income taxes and change in fair value of
warrants.
Specifically, the Company adjusts net income
(loss) for change in fair value of warrants; loss on the
extinguishment of debt; recurring non-cash expenditures, including
share-based compensation expenses; depreciation and amortization;
and interest expense, interest income and income taxes, with a
result of Adjusted EBITDA. Similarly, manufacturing and
supply expense, research and development expense, and selling,
general and administrative expense were adjusted for the recurring
non-cash expenditures of share-based compensation expense and
depreciation and amortization. Adjusted EBITDA and these non-GAAP
expense categories are used as a supplement to the corresponding
GAAP measures to provide additional insight regarding the Company’s
ongoing operating performance.
These measures supplement the Company’s
financial results prepared in accordance with GAAP. Aquestive
management uses these measures to analyze its financial results,
its future manufacturing and supply expenses, gross margins,
research and development expense and selling, general and
administrative expense and to help make managerial decisions. In
management’s opinion, these non-GAAP measures provide added
transparency into the operating performance of Aquestive and added
insight into the effectiveness of our operating strategies and
actions. We may provide one or more revenue measures adjusted for
certain discrete items, such as fees collected on certain licensed
products, in order to provide investors added insight into our
revenue stream and breakdown, along with providing our GAAP
revenue. Such measures are intended to supplement, not act as
substitutes for, comparable GAAP measures and should not be read as
a measure of liquidity for Aquestive. Adjusted EBITDA and the other
non-GAAP measures are also likely calculated in a way that is not
comparable to similarly titled measures reported by other
companies.
Non-GAAP Outlook
In providing outlook for non-GAAP adjusted
EBITDA and non-GAAP gross margin, we exclude certain items which
are otherwise included in determining the comparable GAAP financial
measures. In order to inform our outlook measures of non-GAAP
adjusted EBITDA and non-GAAP gross margin, a description of the
2018 and 2019 adjustments which have been applicable in determining
non-GAAP Adjusted EBITDA and non-GAAP gross margin for these
periods are reflected in the tables below. In providing outlook for
non-GAAP gross margin, we adjust for non-cash share-based
compensation expense and depreciation and amortization. We are
providing such outlook only on a non-GAAP basis because the Company
is unable to predict with reasonable certainty the totality or
ultimate outcome or occurrence of these adjustments for the
forward-looking period such as share-based compensation expense,
income tax, amortization, and certain other adjusted items, which
can be dependent on future events that may not be reliably
predicted. Based on past reported results, where one or more of
these items have been applicable, such excluded items could be
material, individually or in the aggregate, to reported
results.
Forward-Looking StatementThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “believe,” “anticipate,” “plan,” “expect,”
“estimate,” “intend,” “may,” “will,” or the negative of those
terms, and similar expressions, are intended to identify
forward-looking statements. These forward-looking statements may
include, but are not limited to, statements regarding therapeutic
benefits and plans and objectives for regulatory approvals of
AQST-108, Libervant and our other product candidates; ability to
obtain FDA approval and advance AQST-108, Libervant and our other
product candidates to the market; statements about our growth and
future financial and operating results and financial position,
regulatory approval and pathways, clinical trial timing and plans,
our and our competitors’ orphan drug approval and resulting drug
exclusivity for our products or products of our competitors,
short-term and long-term liquidity and cash requirements, cash
funding and cash burn, business strategies, market opportunities,
and other statements that are not historical facts.
These forward-looking statements are based on
our current expectations and beliefs and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
Such risks and uncertainties include, but are not limited to, risks
associated with the Company's development work, including any
delays or changes to the timing, cost and success of our product
development activities and clinical trials and plans; risk of
delays in FDA approval of Libervant and our other drug candidates
or failure to receive approval; risk of our ability to demonstrate
to the FDA “clinical superiority” within the meaning of FDA
regulations of our drug candidate Libervant relative to the
FDA-approved alternative diazepam rectal gel and nasal spray
products, including by establishing a major contribution to patient
care within the meaning of FDA regulations relative to the approved
products, to overcome the seven year orphan drug exclusivity
granted by the FDA for the approved nasal spray product of a
competitor in the U.S., and there can be no assurance that we will
be successful; risk that a competitor obtains FDA orphan drug
exclusivity for a product with the same active moiety as any of our
other drug products for which we are seeking FDA approval and that
such earlier approved competitor orphan drug blocks such other
product candidates in the U.S. for seven years for the same
indication; risk inherent in commercializing a new product
(including technology risks, financial risks, market risks and
implementation risks and regulatory limitations); risk of
development of our sales and marketing capabilities; risk of legal
costs associated with and the outcome of our patent litigation
challenging third party at risk generic sale of our proprietary
products; risk of sufficient capital and cash resources, including
access to available debt and equity financing and revenues from
operations, to satisfy all of our short-term and longer term cash
requirements and other cash needs, at the times and in the amounts
needed; risk of failure to satisfy all financial and other debt
covenants and of any default; risk related to government claims
against Indivior for which we license, manufacture and sell
Suboxone and which accounts for the substantial part of our current
operating revenues; risks associated with Indivior’s cessation of
production of its authorized generic buprenorphine naloxone film
product, including the impact from loss of orders for the
authorized generic product and risk of eroding market share for
Suboxone and risk of sunsetting product; risks related to
coronavirus and potential impact on global businesses as well as
clinical trials, sourcing, regulatory approval and
commercialization of our products and product candidates; risks
related to the outsourcing of certain sales, marketing and other
operational and staff functions to third parties; risk of the rate
and degree of market acceptance of our products and product
candidates; the success of any competing products, including
generics; risk of the size and growth of our product markets; risk
of compliance with all FDA and other governmental and customer
requirements for our manufacturing facilities; risks associated
with intellectual property rights and infringement claims relating
to the Company's products; risk of unexpected patent developments;
the impact of existing and future legislation and regulatory
provisions on product exclusivity; legislation or regulatory action
affecting pharmaceutical product pricing, reimbursement or access;
claims and risks that may arise regarding the safety or efficacy of
the Company's products and product candidates; risk of loss of
significant customers; risks related to legal proceedings,
including patent infringement, investigative and antitrust
litigation matters; changes in governmental laws and regulations;
risk of product recalls and withdrawals; uncertainties related to
general economic, political, business, industry, regulatory and
market conditions and other unusual items; and other risks and
uncertainties affecting the Company including those described in
the “Risk Factors” section and in other sections included in the
Company's Annual Report on Form 10‑K filed with the SEC, in our
quarterly reports on Form 10-Q, and in the Form 8-K filed on
January 13, 2020. Given these uncertainties, you should not place
undue reliance on these forward-looking statements, which speak
only as of the date made. All subsequent forward-looking statements
attributable to us or any person acting on our behalf are expressly
qualified in their entirety by this cautionary statement. The
Company assumes no obligation to update forward-looking statements
or outlook or guidance after the date of this press release whether
as a result of new information, future events or otherwise, except
as may be required by applicable law.
Additional Information Regarding Orphan
Drug ExclusivityIn a recent decision, the FDA’s Center for
Drug Evaluation and Research granted marketing exclusivity for
seven years to Valtoco®, a drug approved for the labeled indication
of acute treatment of intermittent stereotypic episodes of frequent
seizure activity (i.e., seizure clusters, acute repetitive
seizures) that are distinct from a patient’s usual seizure pattern
in patients with epilepsy six years of age and older.
Although we cannot be assured of the FDA’s approval of Libervant or
finding that Libervant represents a “major contribution to patient
care” to overcome this market exclusivity, Aquestive remains
committed to helping people affected by seizure clusters and acute
repetitive seizures by looking to bring important innovative
products to the market that will improve the lives of patients. In
the FDA’s response to the Company’s Citizen’s Petition dated
November 1, 2019, the FDA outlined the pertinent factors that may
be considered by the FDA, under appropriate circumstances, in
making a determination of “major contribution to patient care” for
“clinical superiority” as: convenient treatment location; duration
of treatment; patient comfort; reduced treatment burden; advances
in ease and comfort of drug administration; longer periods between
doses; and potential for self-administration. The FDA also
discussed in the Citizen’s Petition the relevant law regarding a
determination of “clinically superior” as follows:
“Section 527 of the [Federal Food, Drug, and
Cosmetic Act] defines “clinically superior” to mean “the drug
provides a significant therapeutic advantage over and above an
already approved or licensed drug in terms of greater efficacy,
greater safety, or by providing a major contribution to patient
care.” The orphan-drug regulations elaborate on the definition of
“clinically superior” as follows:
Clinically superior means that a drug is shown
to provide a significant therapeutic advantage over and above that
provided by an approved drug (that is otherwise the same drug) in
one or more of the following ways:
Greater effectiveness
than an approved drug (as assessed by effect on a clinically
meaningful endpoint in adequate and well controlled clinical
trials). Generally, this would represent the same kind of evidence
needed to support a comparative effectiveness claim for two
different drugs; in most cases, direct comparative clinical trials
would be necessary; or Greater safety in a substantial portion of
the target populations, for example, by the elimination of an
ingredient or contaminant that is associated with relatively
frequent adverse effects. In some cases, direct comparative
clinical trials will be necessary; or In unusual cases, where
neither greater safety nor greater effectiveness has been shown, a
demonstration that the drug otherwise makes a major contribution to
patient care.
Because of the diverse ways in which drugs may
qualify as clinically superior under these criteria, FDA evaluates
clinical superiority on a case by case basis. Specifically, with
respect to the major contribution to patient care prong of the
clinical superiority definition, the FDA has further stated:
There is no way to
quantify such superiority in a general way. The amount and kind of
superiority needed would vary depending on many factors, including
the nature and severity of the disease or condition, the quality of
the evidence presented, and diverse other factors; and The
following factors, when applicable to severe or life-threatening
diseases, may in appropriate cases be taken into consideration when
determining whether a drug makes a major contribution to patient
care: convenient treatment location; duration of treatment; patient
comfort; reduced treatment burden; advances in ease and comfort of
drug administration; longer periods between doses; and potential
for self-administration.”
__________________________________PharmFilm®,
Sympazan® and the Aquestive logo are registered trademarks of
Aquestive Therapeutics, Inc. All other registered trademarks
referenced herein are the property of their respective owners.
SYMPAZAN IMPORTANT SAFETY INFORMATIONBOXED
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDSConcomitant use of
benzodiazepines and opioids may result in profound sedation,
respiratory depression, coma, and death.
- Reserve concomitant prescribing of these drugs for use in
patients for whom alternative treatment options are
inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory
depression and sedation.
CONTRAINDICATIONSSYMPAZAN is contraindicated in patients with a
history of hypersensitivity to the drug or its ingredients.
Hypersensitivity reactions have included serious dermatological
reactions.
WARNINGS AND PRECAUTIONSPotentiation of Sedation from
Concomitant Use with Central Nervous System (CNS)
DepressantsSYMPAZAN has a CNS depressant effect. Caution patients
and/or caregivers against simultaneous use with other CNS
depressants or alcohol as the effects of other CNS depressants or
alcohol may be potentiated.
Somnolence or SedationSYMPAZAN causes dose-related somnolence
and sedation, which generally begins within the first month of
treatment and may diminish with continued treatment. Monitor
patients for somnolence and sedation, particularly with concomitant
use of other CNS depressants. Caution patients against engaging in
hazardous activities requiring mental alertness, i.e., operating
dangerous machinery or motor vehicles, until the effect of SYMPAZAN
is known.
Withdrawal SymptomsAbrupt discontinuation of SYMPAZAN should be
avoided. The risk of withdrawal symptoms is greater with higher
doses. Withdraw SYMPAZAN gradually to minimize the risk of
precipitating seizures, seizure exacerbation, or status
epilepticus.
Serious Dermatological ReactionsSerious skin reactions,
including Stevens-Johnson syndrome (SJS) and toxic epidermal
necrolysis (TEN), have been reported with clobazam in both children
and adults. Discontinue SYMPAZAN at the first sign of rash, unless
the rash is clearly not drug-related.
Physical and Psychological DependencePatients with a history of
substance abuse should be under careful surveillance when receiving
SYMPAZAN.
Suicidal Behavior and IdeationAEDs, including SYMPAZAN, increase
the risk of suicidal thoughts or behavior in patients. Patients
treated with SYMPAZAN should be monitored for the emergence or
worsening of depression, suicidal thoughts or behavior, and/or any
unusual changes in mood or behavior. Inform patients, their
caregivers, and families of the increased risk of suicidal thoughts
and behaviors. Advise them to be alert for and report immediately
to healthcare providers any emergence or worsening signs and
symptoms of depression, any unusual changes in mood or behavior, or
the emergence of suicidal thoughts, behavior, or thoughts of
self-harm.
ADVERSE REACTIONSAdverse reactions (≥10% and more frequently
than placebo) included constipation, somnolence or sedation,
pyrexia, lethargy, and drooling.
DRUG INTERACTIONSThe concomitant use of benzodiazepines and
opioids increases the risk of respiratory depression. Limit dosage
and duration of concomitant use of benzodiazepines and opioids and
follow patients closely for respiratory depression and sedation.
Concomitant use of SYMPAZAN with other CNS depressants, including
alcohol, may increase the risk of sedation and somnolence. Caution
patients and/or caregivers against simultaneous use with other CNS
depressants or alcohol, as effects of other CNS depressants or
alcohol may be potentiated.Hormonal contraceptives that are
metabolized by CYP3A4; effectiveness may be diminished when given
with SYMPAZAN. Additional non-hormonal forms of contraception are
recommended when using SYMPAZAN. Dose adjustment may be necessary
of drugs metabolized by CYP2D6 and of SYMPAZAN when co-administered
with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine,
ticlopidine).
USE IN SPECIFIC POPULATIONSPregnancy and Lactation: SYMPAZAN may
cause fetal harm and should only be used during pregnancy if the
potential benefit justifies the potential risk to the fetus.
Infants born to mothers who have taken benzodiazepines during the
later stages of pregnancy can develop dependence, withdrawal
syndrome and symptoms suggestive of floppy infant syndrome.
SYMPAZAN is excreted in human milk. Because of the potential for
serious adverse reactions in nursing infants from SYMPAZAN,
discontinue nursing or discontinue the drug. Encourage patients to
call the toll-free number 1-888-233-2334 to enroll in the Pregnancy
Registry or visit http://www.aedpregnancyregistry.org/.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Please click here to see full Prescribing Information, including
the Boxed Warning.
|
AQUESTIVE
THERAPEUTICS, INC. |
Consolidated
Statements of Operations and Comprehensive Loss |
(In
thousands, except share and per share data amounts) |
(Audited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Year
Ended |
|
|
|
December 31, |
|
December
31, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
16,419 |
|
|
$ |
16,824 |
|
|
$ |
52,609 |
|
|
$ |
67,430 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Manufacture and supply |
|
6,792 |
|
|
|
4,787 |
|
|
|
20,361 |
|
|
|
20,988 |
|
|
Research and development |
|
3,057 |
|
|
|
5,683 |
|
|
|
20,574 |
|
|
|
23,112 |
|
|
Selling, general and administrative |
|
16,474 |
|
|
|
18,710 |
|
|
|
64,342 |
|
|
|
72,269 |
|
|
|
Total costs and expenses |
|
26,323 |
|
|
|
29,180 |
|
|
|
105,277 |
|
|
|
116,369 |
|
|
|
Loss from
operations |
|
(9,904 |
) |
|
|
(12,356 |
) |
|
|
(52,668 |
) |
|
|
(48,939 |
) |
Other income/(expenses): |
|
|
|
|
|
|
|
|
Interest expense |
|
(2,803 |
) |
|
|
(1,902 |
) |
|
|
(9,318 |
) |
|
|
(7,711 |
) |
|
Interest income |
|
71 |
|
|
|
314 |
|
|
|
636 |
|
|
|
552 |
|
|
Loss on extinguishment of debt |
|
- |
|
|
|
- |
|
|
|
(4,896 |
) |
|
|
- |
|
|
Change in fair value of warrant |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5,278 |
) |
|
|
Loss before
income taxes |
|
(12,636 |
) |
|
|
(13,944 |
) |
|
|
(66,246 |
) |
|
|
(61,376 |
) |
|
Income taxes |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Net loss and comprehensive loss |
|
(12,636 |
) |
|
|
(13,944 |
) |
|
|
(66,246 |
) |
|
|
(61,376 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
$ |
(0.48 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.61 |
) |
|
$ |
(2.96 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares |
|
|
|
|
|
|
|
|
outstanding - basic and diluted |
|
26,435,840 |
|
|
|
24,942,185 |
|
|
|
25,356,098 |
|
|
|
20,725,526 |
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
Consolidated
Balance Sheets |
(In
thousands, except share amounts) |
(Audited) |
|
|
|
|
|
|
|
|
|
December
31, |
|
December
31, |
Assets |
2019 |
|
2018 |
|
|
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
49,326 |
|
|
$ |
60,599 |
|
|
Trade and other receivables, net |
|
13,130 |
|
|
|
6,481 |
|
|
Inventories, net |
|
2,859 |
|
|
|
5,441 |
|
|
Prepaid expenses and other current assets |
|
2,999 |
|
|
|
1,680 |
|
|
|
Total current assets |
|
68,314 |
|
|
|
74,201 |
|
Property and equipment, net |
|
9,726 |
|
|
|
12,207 |
|
Intangible assets, net and other assets |
|
439 |
|
|
|
443 |
|
|
|
Total
assets |
$ |
78,479 |
|
|
$ |
86,851 |
|
|
|
|
|
|
|
Liabilities
and stockholders' deficit/equity |
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
12,274 |
|
|
$ |
20,436 |
|
|
Accrued expenses |
|
5,475 |
|
|
|
7,195 |
|
|
Deferred revenue, current |
|
806 |
|
|
|
721 |
|
|
Loans payable, current |
|
- |
|
|
|
4,600 |
|
|
|
Total
current liabilities |
|
18,555 |
|
|
|
32,952 |
|
|
Deferred revenue, net of current portion |
|
4,348 |
|
|
|
- |
|
|
Loans payable, net |
|
60,338 |
|
|
|
42,603 |
|
|
Asset retirement obligations |
|
1,360 |
|
|
|
1,216 |
|
|
|
Total
liabilities |
|
84,601 |
|
|
|
76,771 |
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
Stockholders' (deficit)/equity: |
|
|
|
|
Common stock, $.001 par value. Authorized 250,000,000 shares;
33,562,885 and |
|
|
|
|
24,957,309 shares issued and outstanding at December 31, 2019 and
2018, respectively |
|
34 |
|
|
|
25 |
|
|
Additional paid-in capital |
|
124,318 |
|
|
|
71,431 |
|
|
Accumulated deficit |
|
(130,474 |
) |
|
|
(61,376 |
) |
|
|
Total
stockholders' (deficit)/equity |
|
(6,122 |
) |
|
|
10,080 |
|
|
|
Total
liabilities and stockholders' (deficit)/equity |
$ |
78,479 |
|
|
$ |
86,851 |
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - GAAP Expenses to
Adjusted Expenses |
(In
Thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Year
Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
$ |
26,323 |
|
|
$ |
29,180 |
|
|
$ |
105,277 |
|
|
$ |
116,369 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
(1,873 |
) |
|
|
(1,399 |
) |
|
|
(7,071 |
) |
|
|
(29,940 |
) |
|
|
Depreciation
and amortization |
|
(723 |
) |
|
|
(760 |
) |
|
|
(2,905 |
) |
|
|
(3,236 |
) |
Adjusted costs and expenses |
$ |
23,727 |
|
|
$ |
27,021 |
|
|
$ |
95,301 |
|
|
$ |
83,193 |
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - GAAP Manufacture
& Supply Expense to Adjusted Manufacture & Supply
Expense |
(In
Thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Year
Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
Manufacture and supply expense |
$ |
6,792 |
|
|
$ |
4,787 |
|
|
$ |
20,361 |
|
|
$ |
20,988 |
|
|
|
Gross margin on total revenue |
|
59 |
% |
|
|
72 |
% |
|
|
61 |
% |
|
|
69 |
% |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based
compensation expense |
|
(50 |
) |
|
|
(37 |
) |
|
|
(221 |
) |
|
|
(414 |
) |
|
|
Depreciation
and amortization |
|
(585 |
) |
|
|
(615 |
) |
|
|
(2,350 |
) |
|
|
(2,618 |
) |
Adjusted manufacture and supply expense |
$ |
6,157 |
|
|
$ |
4,135 |
|
|
$ |
17,790 |
|
|
$ |
17,956 |
|
|
|
Non-GAAP
gross margin on total revenue |
|
63 |
% |
|
|
75 |
% |
|
|
66 |
% |
|
|
73 |
% |
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - GAAP Research and
Development Expense to Adjusted Research and Development
Expense |
(In
Thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Year
Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
Research and development expense |
$ |
3,057 |
|
|
$ |
5,683 |
|
|
$ |
20,574 |
|
|
$ |
23,112 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
(185 |
) |
|
|
(205 |
) |
|
|
(720 |
) |
|
|
(2,583 |
) |
|
|
Depreciation
and amortization |
|
(65 |
) |
|
|
(109 |
) |
|
|
(265 |
) |
|
|
(368 |
) |
Adjusted research and development expense |
$ |
2,807 |
|
|
$ |
5,369 |
|
|
$ |
19,589 |
|
|
$ |
20,161 |
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - GAAP Selling,
General and Administrative Expenses to Adjusted Selling, General
and Administrative Expenses |
(In
Thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Year
Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
$ |
16,474 |
|
|
$ |
18,710 |
|
|
$ |
64,342 |
|
|
$ |
72,269 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
(1,638 |
) |
|
|
(1,157 |
) |
|
|
(6,130 |
) |
|
|
(26,943 |
) |
|
|
Depreciation
and amortization |
|
(73 |
) |
|
|
(36 |
) |
|
|
(290 |
) |
|
|
(250 |
) |
Adjusted selling, general and administrative expenses |
$ |
14,763 |
|
|
$ |
17,517 |
|
|
$ |
57,922 |
|
|
$ |
45,076 |
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - Net Loss to
Adjusted EBITDA |
(In
Thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Year
Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(12,636 |
) |
|
$ |
(13,944 |
) |
|
$ |
(66,246 |
) |
|
$ |
(61,376 |
) |
|
Share-based compensation |
|
1,872 |
|
|
|
1,399 |
|
|
|
7,071 |
|
|
|
29,940 |
|
|
Interest expense, net |
|
2,732 |
|
|
|
1,588 |
|
|
|
8,682 |
|
|
|
7,159 |
|
|
Loss on extinguishment of debt |
|
- |
|
|
|
- |
|
|
|
4,896 |
|
|
|
- |
|
|
Income taxes |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Depreciation and amortization |
|
723 |
|
|
|
760 |
|
|
|
2,905 |
|
|
|
3,236 |
|
|
Change in fair value of warrant |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,278 |
|
|
|
Adjusted EBITDA |
$ |
(7,309 |
) |
|
$ |
(10,197 |
) |
|
$ |
(42,692 |
) |
|
$ |
(15,763 |
) |
|
|
|
|
|
|
|
|
|
|
Investor inquiries:Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
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