Aquestive Therapeutics Advances Royalty Monetization Plan as Sunovion Pharmaceuticals’ Apomorphine Sublingual Film Therapy ...
May 21 2020 - 5:27PM
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 announced plans to advance its strategy to monetize
the anticipated royalties associated with Sunovion Pharmaceuticals’
apomorphine sublingual film APL-130277, which received FDA approval
to treat motor fluctuations (OFF episodes) experienced by people
living with Parkinson’s disease.
Keith J. Kendall, President and Chief Executive
Officer of Aquestive, stated, “We are pleased to see that
the FDA has granted approval for Sunovion’s apomorphine sublingual
film, as expected. This approval is another validation
of the significant value our PharmFilm® based therapies provide in
satisfying unmet needs to certain underserved patient populations.
We expect that this therapy will generate substantial future
license and royalty revenues for our company and we are meeting
with potential investors for the monetization of this royalty
stream. We continue to expect that we will receive between
$50 to $100 million of non-dilutive capital from the monetization,
in one or a series of transactions. The timing of the monetization
will depend on market conditions, and will be executed at a time
that is optimal for Aquestive. Based on our current planning
and expectations, we believe that we are positioned well with
current cash resources and proceeds from a potential monetization
of this royalty stream to extend our capital runway well into 2021
and possibly beyond.”
As disclosed in Aquestive’s filings with the
SEC, in April 2016, Aquestive entered into a license agreement with
Cynapsus Therapeutics (which was later succeeded to in interest by
Sunovion), pursuant to which Aquestive granted Sunovion an
exclusive, worldwide license (with the right to sub-license) to
certain intellectual property, including existing and future
patents and patent applications, covering all oral films containing
APL-130277 (apomorphine) for the treatment of motor fluctuations
(OFF episodes) in Parkinson’s disease patients, as well as two
other therapeutic fields.
About Aquestive
TherapeuticsAquestive Therapeutics is a 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
include, but are not limited to, statements regarding therapeutic
benefits and plans and objectives for regulatory approvals of
AQST-108, LibervantTM 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 also are subject to the uncertain impact
of the COVID-19 global pandemic on our business including with
respect to our clinical trials including site initiation, patient
enrollment and timing and adequacy of clinical trials; on
regulatory submissions and regulatory reviews and approvals of our
product candidates; pharmaceutical ingredient and other raw
materials supply chain, manufacture, and distribution; sale of and
demand of our products; our liquidity and availability of capital
resources; customer demand for our products and services;
customers’ ability to pay for goods and services; and ongoing
availability of an appropriate labor force and skilled
professionals. Given these uncertainties, the Company is
unable to provide assurance that operations can be maintained as
planned prior to the COVID-19 pandemic.
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 the FDA
regulations of our drug candidate Libervant relative to
FDA-approved 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 approval of products 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; risk 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 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 product and product
candidates; the success of any competing products, including
generics; risk of the size and growth of our product markets; risks
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
actions 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 government 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 uncertainties
affecting the Company described in the “Risk Factors” section and
in other sections included in our Annual Report on Form 10‑K, in
our Quarterly Reports on Form 10-Q, and in our Current Reports on
Form 8-K filed with the Securities Exchange Commission (SEC). Given
those 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 registered trademarks referenced herein are
the property of their respective owners.
Investor inquiries:Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
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