Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty
pharmaceutical company focused on developing and commercializing
differentiated products that meet patients’ unmet needs and solve
therapeutic problems, today reported anticipated preliminary
unaudited total revenues for the fourth quarter and full year ended
December 31, 2019 and provided initial full year 2020 guidance.
“In addition to exceeding the top end of our
revenue guidance, we achieved significant milestones, as promised,
in 2019. First, we completed our rolling submission of the New Drug
Application (NDA) for our therapeutic candidate Libervant™
(diazepam) Buccal Film for the management of seizure clusters to
the U.S. Food and Drug Administration (FDA) in November 2019.
Next, we successfully completed a number of early stage clinical
trials regarding AQST-108 (epinephrine), advancing toward our
February 2020 Pre-IND meeting with the FDA to clarify the clinical
and regulatory path forward. These milestones establish a
path forward in 2020 to advance our pipeline and commercial
opportunities,” said Keith J. Kendall, Chief Executive Officer of
Aquestive. “Sympazan® continued to extend its reach in the
prescribing community that will ultimately be vital to the
successful launch of Libervant, subject to approval by the
FDA. We entered 2020 with a strong cash position of
approximately $49 million and, with the announcement by Sunovion of
a May 2020 PDUFA date for APL-130277, we believe that we have a
clear timetable to work toward securing substantial additional
non-dilutive capital in mid-2020. We anticipate current
capital and revenues from monetization of our rights in APL-130277,
subject to approval by the FDA, to fully support our commercial
activities, the expected launch of Libervant, the continued
development of AQST-108 and the identification, investigation and
development of additional product candidates.”
Preliminary Unaudited 2019 Total
Revenues and Cash PositionPreliminary unaudited total
revenues are anticipated to be approximately $16 million for the
fourth quarter 2019 and approximately $52 million for the full year
ended December 31, 2019. 2019 total revenue performance was
driven by the continued strength throughout the year, prior to
Indivior’s announcement of the discontinuance of its authorized
generic product, of Suboxone® and Indivior’s authorized generic
product. Additionally, our first proprietary epilepsy
product, Sympazan, grew steadily from launch, and we recognized
co-development and license fees and royalty revenues in the period
on license activity.
Preliminary unaudited cash and cash equivalents
as of December 31, 2019 were approximately $49 million. In
December 2019, the Company completed a public offering of 8,050,000
shares of common stock for gross proceeds of $40.3 million and net
proceeds of $37.5 million.
Initial Full Year 2020 Financial
Guidance Aquestive is providing initial full year 2020
financial guidance as follows based upon the assumptions outlined
below:
- Total revenues of approximately $35
million to $45 million
- Supply of branded Suboxone at similar volumes to fourth quarter
2019, representing a market share of approximately 48%, and
implemented product price adjustments, but no further meaningful
volumes from the discontinued Sandoz authorized generic
product
- Expected revenues from Sympazan net sales, co-development
programs, and license fees and royalties from licensed
products
- Excludes any net revenues from Libervant as there can be no
guaranty of approval or commercialization
- 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 $65 million to $70 million
- Reflective of anticipated more profitable revenue and
significant cost rationalization in the company’s plant and other
legacy aspects of the business, offset by expected substantially
higher investments in R&D driven by AQST-108 and preparation
for the anticipated launch of Libervant
- Cash burn of approximately $65
million to $70 million after considering interest, capital spending
and working capital effects, but prior to any additional capital
transactions.
Aquestive expects to report fourth quarter and
full year 2019 audited results on Thursday, March 12, 2020.
About Aquestive
TherapeuticsAquestive Therapeutics is a specialty
pharmaceutical company that applies innovative technology to solve
therapeutic problems and improve medicines for patients. Aquestive
is advancing a late-stage proprietary product pipeline 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 OutlookIn providing
outlook for non-GAAP adjusted gross margins
and non-GAAP adjusted EBITDA, we exclude certain items
which are otherwise included in determining the comparable GAAP
financial measures. 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 Statement
This 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
Libervant and our other product candidates; ability to obtain FDA
approval and advance 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 that a competitor obtains FDA
orphan drug exclusivity for a product with the same active
moiety as the orphan drug product for which we are seeking FDA
approval and that such earlier approved competitor orphan drug
blocks our product in the U.S. for seven years for the same
indication, including the possible earlier approval of the product
candidate, Valtoco® (diazepam intranasal solution) with respect to
our product candidate Libervant (diazepam buccal film); 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 announcement of its intention to cease
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 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 on
March 14, 2019 and in our quarterly reports on Form 10-Q. 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.
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.
Investor inquiries: Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
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