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 A. Ernest (Ernie) Toth, Jr., a
seasoned financial executive and currently serving the Company as
the interim Chief Financial Officer, has transitioned to the
permanent role of Senior Vice President and Chief Financial Officer
effective immediately.
“Ernie is a seasoned and experienced financial
executive. He has become a valued member of our team and an
important part of our external relationships in the financial
community. We look forward to the effective leadership of the
financial functions of the Company that Ernie will bring,” said
Keith Kendall, Director, President and Chief Executive Officer of
Aquestive.
About Mr. TothErnie Toth joined
Aquestive as Interim CFO in December, 2020 through the services of
Danforth Advisors, a consulting firm providing finance support and
strategic advisory services to life science companies and the
healthcare technology industry. Prior to joining Aquestive, Mr.
Toth was CFO of EHE Health, a national preventive health, primary
care, and telehealth network owned by Summit Partners and DW
Healthcare Partners. From January, 2016 to December, 2016, Mr. Toth
was Chief Financial Officer of ArisGlobal, an end-to-end drug
development platform, and from January, 2015 to December, 2015, he
served as Global Chief Financial Officer of Synowledge, a global
life sciences solutions company providing drug safety, regulatory
affairs and IT services to diverse pharmaceutical, biotechnology
and medical devices companies. Owned by the Abbhi family, at both
ArisGlobal and Synowledge, he led Finance, HR, IT, Legal, and
Commercial Operations during periods of high growth and the sale of
Synowledge to Bioclinica. Mr. Toth was Chief Financial Officer from
2011 to 2013 of JHP Pharmaceuticals, a PE owned (Morgan Stanley
Private Investments) integrated specialty healthcare company that
develops, manufactures and sells branded and generic aseptic
injectable pharmaceuticals and provides contract manufacturing
services for global pharmaceutical companies. As CFO, Mr. Toth
provided financial and operational leadership through 9 new product
launches, 17 ANDA filings, a BARDA award, clinical trials and the
sale to Warburg Pincus in 2012. From 2014 until its sale to a
strategic buyer in 2017, Mr. Toth was a member of the Board of
Directors of Eska, a leading Canadian beverage company owned by
Morgan Stanley Private Investments. Mr. Toth’s prior experience
includes senior financial leadership positions at Valeritas,
Pharmaceutical Formulations, and World Power Technologies. He spent
15 years in various financial positions at MacAndrews & Forbes,
the investment company owned by Ronald O. Perelman. Mr. Toth holds
an MBA from Pace University, a BS in Accounting from Shippensburg
University of Pennsylvania, and is a CPA in the State of New
York.
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.
For this purpose, any statements contained herein that are not
statements of historical fact may be deemed to be forward-looking
statements. Without limiting the foregoing, 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 are based on
our current expectations and beliefs about future events and
financial trends that the Company believes may affect its business,
financial condition and results of operations 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
the Company’s product development activities and clinical trials
and plans; risk of delays in FDA approval of the Company’s product
candidate Libervant and other drug candidates or failure to receive
approval; 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; 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 inherent in commercializing a new product
(including technology risks, financial risks, market risks and
implementation risks and regulatory limitations); risks and
uncertainties concerning the royalty and other revenue stream of
the Company’s KYNMOBI monetization transaction, 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, 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; risks relating to the
impact and uncertainties of the COVID-19 global pandemic on our
business and operations 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; 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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