Aquestive Therapeutics Announces Departure of Chief Financial Officer and Appointment of Interim Chief Financial Officer
December 16 2020 - 8:00AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, today announced that John Maxwell, Senior Vice President,
Chief Financial Officer (CFO) of the Company, has provided his
intent to resign his positions with the Company to pursue other
interests. Current plans call for Mr. Maxwell to continue to serve
as CFO of the Company until his departure, which currently is
anticipated at year end. Mr. Ernie Toth, a seasoned financial
executive most recently with EHE Health as Chief Financial Officer,
will assume the role of CFO on an interim basis upon Mr. Maxwell’s
departure.
“We have made meaningful progress in our
business since John joined the Company in January 2017,” said Keith
J. Kendall, President and Chief Executive Officer of Aquestive.
“John has been a valuable part of the continued development of the
Company. We thank him for his contributions, especially in
shepherding our efforts to become a public company and close
several critical capital markets transactions. The management team
and board of directors of Aquestive joins me in wishing him well in
his future business pursuits. We anticipate effecting a very smooth
transition over the next few weeks and are pleased to welcome Mr.
Toth as the new interim CFO to our team,” concluded Mr.
Kendall.
“I have enjoyed my time with Aquestive
Therapeutics,” said Mr. Maxwell. “Upon arrival, my immediate
objective was to help evolve the capitalization of the Company.
Aquestive was in the midst of its transformation into a commercial
proprietary pharmaceutical company. Having accomplished this
critical goal, I believe the Company is well positioned for future
growth and I believe in the strength of the Aquestive business. I
wish the team all the best for its continued success.”
The Company also reported that Mr. Maxwell’s
departure is not related to the Company’s operations, financial
reporting or controls.
2020 Outlook
The Company also announced that there is no
change to its full year 2020 financial outlook.
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 therapeutic
benefits and plans and objectives for regulatory approvals of
AQST-108 and Libervant; ability to address the concerns identified
in the FDA’s Complete Response Letter dated September 25, 2020
regarding the New Drug Application for Libervant and obtain FDA
approval of Libervant for U.S. market access; ability to obtain FDA
approval and advance AQST-108, Libervant and our other product
candidates to the market; about our growth and future financial and
operating results and financial position; regulatory approval and
pathway; 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
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 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); 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 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 (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. All other registered
trademarks referenced herein are the property of their respective
owners.
Investor Inquiries:Westwicke, an ICR CompanyStephanie
Carringtonstephanie.carington@westwicke.com646-277-1282
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