Aquestive Therapeutics Reaffirms Full Year 2019 Revenue Guidance and Will Announce Third Quarter 2019 Financial Results and R...
October 15 2019 - 5:41PM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty
pharmaceutical company focused on developing and commercializing
differentiated products to solve therapeutic problems, today
announced, in response to Indivior PLC’s press release issued
earlier today of Indivior’s intent to cease production of its
authorized generic buprenorphine-naloxone film product, that the
Company is reaffirming its full year 2019 total revenue
guidance. Full year 2019 total revenue is now expected to be
at the top end of the Company’s guidance range of $38 million to
$45 million. Full year 2019 revenue from the Company’s Suboxone®
franchise is expected to be at the top end of its guidance range of
$29 million to $32 million. As of October 2019, Suboxone and
the authorized generic buprenorphine-naloxone film continue to
retain approximately 75% of the market for film treatments of
opioid dependence, of which a substantial majority of its retained
market share is branded Suboxone.
“The key value drivers of our business continue
to be our proprietary products addressing unmet needs for highly
differentiated solutions for patients with epilepsy and other
disease conditions,” said Keith J. Kendall, Chief Executive
Officer of Aquestive. “As expected, we filed the CMC portion of our
rolling NDA submission for Libervant™ (diazepam buccal film) with
the FDA in September 2019 and expect to complete the filing in
fourth quarter 2019. We also recently reported positive
results from our Phase 1 dose escalation proof-of-concept study in
healthy subjects for AQST-108 that is in development for the
treatment of anaphylaxis.”
Mr. Kendall added, “Suboxone has exceeded our
expectations in terms of market share retention since the entry of
generics. Based on this market performance, Aquestive has a
strong order book for the full year 2019. As the exclusive
manufacturer of Suboxone, we expect that this product will continue
to generate meaningful revenue for the foreseeable future.
While Suboxone is important to us, we have continued to plan
for the erosion of this sunsetting product over time, and continue
to focus on delivering our proprietary pipeline of highly valuable
products to patients with epilepsy and other disease conditions in
need of improved treatments.”
Third Quarter 2019 Conference Call and
WebcastAquestive announced that it will report results for
the third quarter ended September 30, 2019 and provide a business
update on Wednesday, November 6, 2019 before the market open. The
Company will host an investment community conference call at 8:00
a.m. ET on Wednesday, November 6, 2019. 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: 4779544. 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 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.
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 about our growth and future financial and operating
results and financial position, ability to advance Libervant and
our other product candidates to the market, regulatory approvals
and pathways, clinical trial timing and plans, 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; risk of delays in FDA
approval of our drug candidates or failure to receive approval;
risk inherent in commercializing a new product (including
technology risks, financial risks, market risks and implementation
risks and regulatory limitations); risk that a competitor obtains
orphan drug exclusivity and blocks our product for the same
indication for seven years; 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 announced intent to cease production of
its authorized generic buprenorphine-naloxone film product,
including risk of loss of orders for the authorized generic product
and eroding market share for Suboxone and the authorized generic
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; risk of claims and concerns 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® and the Aquestive logo are registered
trademarks of Aquestive Therapeutics, Inc. All other
trademarks are the property of their respective owners.
Media and Investor inquiries: Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
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