Aquestive Therapeutics Receives First Milestone Payment from KYNMOBI™ Monetization
November 23 2020 - 7:00AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, announced today receipt of the first milestone payment of
$10 million under the previously announced royalty monetization
agreement with an affiliate of Marathon Asset Management, a leading
global investment firm (“Marathon”), bringing total cash proceeds
this quarter to $50 million.
In conjunction with the receipt of the first
milestone payment and closing of the monetization transaction,
Aquestive has repaid a portion of certain senior notes and plans to
utilize the remaining net proceeds to fund the Company’s ongoing
development and commercialization of its proprietary product and
pipeline candidates, as well as for working capital purposes. Under
the terms of the monetization agreement, Aquestive is eligible to
receive up to the additional $75 million of milestone payments at
various points based on the achievement of worldwide royalty
targets. This includes up to $15 million potentially available in
2021 and through mid-2022.
“We are pleased to have met the first milestone
of our agreement with Marathon and to have received the additional
proceeds of $10 million this quarter. These proceeds will help to
execute on advancing our key clinical and commercial initiatives,
including the resubmission of our NDA for FDA approval of our lead
product Libervant™ (diazepam) Buccal Film, for the management of
seizure clusters, and our ongoing clinical development program for
AQST-108, an oral sublingual film formulation delivering systemic
epinephrine,” remarked Keith J. Kendall, President and Chief
Executive Officer of Aquestive.
About Aquestive
TherapeuticsAquestive Therapeutics is a pharmaceutical
company that applies innovative technology to solve therapeutic
problems and improve medicines for patients. The Company has
commercialized one internally-developed proprietary product to
date, Sympazan, has a commercial proprietary product pipeline
focused on the treatment of diseases of the central nervous system,
or CNS, and other unmet needs, and is developing orally
administered complex molecules to 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 the FDA’s
confirmation that modeling and simulations are a potential path
forward to approval; the Company’s belief that the additional
information requested by the FDA is available based on previously
conducted studies and that no additional clinical studies will be
required for resubmission of the New Drug Application (NDA) for
Libervant; the timing of the NDA resubmission to the FDA; ability
to address the concerns identified in the FDA’s Complete Response
Letter dated September 25, 2020 regarding the NDA for Libervant and
obtain FDA approval of Libervant for U.S. market access;
therapeutic benefits of Libervant; and other statements that are
not historical facts. These forward-looking statements are also
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 for 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 approved products as well as risks
related to other potential pathways or positions which are or may
in the future be advanced to the FDA 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 other FDA marketing exclusivity that blocks U.S. market
access for Libervant; risk inherent in commercializing a new
product (including technology risks, financial risks, market risks
and implementation risks and regulatory limitations); risks for
consummating the monetization transaction for KYNMOBI™ and other
risks and uncertainties concerning the royalty and other revenue
stream of KYNMOBI, achievement of royalty targets worldwide or in
any jurisdiction and certain other commercial targets required for
contingent milestone payments under the monetization transaction,
and of sufficiency of net proceeds of the monetization transaction
after satisfaction of and compliance with 12.5% Senior Notes
obligations, as applicable, and for funding the Company’s
operations; 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 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. 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.
Aquestive Investor Inquiries:
Westwicke, an ICR CompanyStephanie
Carringtonstephanie.carrington@westwicke.com646-277-1282
Aquestive Therapeutics (NASDAQ:AQST)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aquestive Therapeutics (NASDAQ:AQST)
Historical Stock Chart
From Apr 2023 to Apr 2024