Aquestive Therapeutics Reaches Agreement to Extend Principal Payments Due Under Credit Facility to March 30, 2023 and Receives Bridge Waiver of Principal Debt Payment in Advance of Concluding Formal Agreement
October 06 2021 - 5:59PM
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 that it has reached an agreement with its
lenders providing for a bridge waiver of the first principal
payment due under its 12.5% Senior Secured Notes (the “Notes”) in
order to provide sufficient time for the parties to execute a
definitive agreement to extend the time when the first principal
payment is due under the Notes to March 30, 2023.
Pursuant to the proposed amendment of the Notes,
the amortization schedule under the Notes would be amended to
provide for the date of the first principal payment to be made on
March 30, 2023, while maintaining the current maturity date and
interest payment obligations under the Notes (the “Definitive
Agreement”). In consideration of this extension, upon the execution
of the intended Definitive Agreement, Aquestive will agree to pay
to the holders of the Notes an aggregate payment of $2.7 million
payable in four equal quarterly installments beginning on March 30,
2022. The bridge waiver provided by the lenders resulted in the
deferral of the first principal payment due under the Notes and
expires upon the occurrence of the earlier to occur of the
execution of the intended Definitive Agreement and December 31,
2021 or such later date consented to by the holders of the
Notes.
Keith Kendall, Chief Executive Officer of
Aquestive, stated, “We appreciate and value the continued
constructive support received from our lenders, as further
evidenced by their prior agreement to extend until June 30, 2022 at
the Company’s option to access additional debt of $30 million under
the Credit Facility upon FDA approval of our product candidate
Libervant™ (diazepam) Buccal Film for U.S. market access. We
believe the bridge waiver and proposed amendment terms agreed to by
our lenders demonstrate the confidence of our stakeholders in our
investment strategy and performance to date. We expect that the
Definitive Agreement will be executed in the next few days. This
amendment of our Credit Facility, our access to the additional $30
million of debt under the Credit Facility, strong operating results
and appropriate ATM access will continue to provide the capital to
meet our immediate needs including the potential launch of
Libervant, if approved by the FDA for U.S. market access. We
continue to believe that Libervant, our non-invasive and innovative
PharmFilm® product candidate for refractory epilepsy, is well
positioned to improve the quality of life for patients suffering
from this disease with this first of its kind treatment
option.”
About LibervantLibervant™ is a
buccally, or inside of the cheek, administered soluble film
formulation of diazepam, a benzodiazepine intended for rapid
treatment of acute uncontrolled seizures in selected, refractory
patients with epilepsy on stable regimens of AEDs who require
intermittent use of diazepam to control bouts of increased seizure
activity. Aquestive is developing Libervant as an alternative to
Diastat (diazepam rectal gel), the current standard of care rescue
therapy for patients with refractory epilepsy which, as a rectal
gel, is invasive, inconvenient, and difficult to administer. As a
result, a large portion of the patient population does not receive
adequate treatment or foregoes treatment altogether. The Company
believes that Libervant will enable a larger share of these
patients to receive more appropriate treatment by providing
consistent therapeutic dosing in a non-invasive and innovative
treatment form for epileptic seizures. The U.S. Food and Drug
Administration (FDA) has accepted for filing the resubmission of
the New Drug Application (NDA) for Libervant and assigned a
Prescription Drug User Fee Act (“PDUFA”) target goal date of
December 23, 2021. Based upon the Agency’s guidance, the submission
included additional statistical modeling and supporting analyses of
the existing clinical data. The Company continues to believe that
no additional clinical studies will be required for FDA approval of
Libervant for U.S. market access.
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® (clobazam) oral film, 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 Statement
This press release includes “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. For this purpose, 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 impact and importance of the Credit
Facility amendment, the potential approval of Libervant™, the
impact of and prospects for Libervant and business strategies,
market opportunities, and other statements that are not historical
facts. These forward-looking statements 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 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, the
risk that the Definitive Agreement may not be agreed 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
establishing a PDUFA date for and FDA approval of Libervant or
failure to receive approval; ability to address the concerns
identified in the FDA’s Complete Response Letter (CRL) for
Libervant received by the Company in September 2020; risk of our
ability to demonstrate to the FDA “clinical superiority” within the
meaning of the FDA regulations of 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 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 in obtaining
market access for other reasons; 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
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; 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; 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 (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®, Sympazan® and the Aquestive logo are
registered trademarks of Aquestive Therapeutics, Inc.
Investor Inquiries Westwicke, an ICR Company
Stephanie Carrington
stephanie.carrington@westwicke.com646-277-1282
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