This summary highlights information contained in other parts of
this prospectus or incorporated by reference into this prospectus
from our filings with the Securities and Exchange Commission (the
“SEC”). As it is only a summary, it does not contain all of the
information that you should consider before purchasing our
securities and it is qualified in its entirety by, and should be
read in conjunction with, any applicable prospectus supplement and
the more detailed information appearing elsewhere or incorporated
by reference into this prospectus. You should read the entire
prospectus, any applicable prospectus supplement, the registration
statement of which this prospectus is a part, and the information
incorporated by reference herein in their entirety, including the
“Risk Factors” and our financial statements and the related notes
contained in and incorporated by reference into this prospectus,
before purchasing our securities.
Unless the context indicates otherwise, references in this
prospectus to “Aquestive,” “company,” “we,” “us” and “our” refer to
Aquestive Therapeutics, Inc. and its consolidated
subsidiaries.
Company Overview
We are a pharmaceutical company focused on developing and
commercializing differentiated products which leverage our
proprietary PharmFilm® technology to meet patients’ unmet medical
needs and to solve patients’ therapeutic problems. We have five
products approved by the U.S. Food and Drug Administration (FDA),
both proprietary and out-licensed, as well as a late-stage
proprietary product pipeline focused on the treatment of central
nervous system, or CNS, diseases and an earlier stage pipeline
including treatment of anaphylaxis. Our licensees market their
products in the US and in some instances outside the US. The
company markets its proprietary product in the US. We believe that
our proprietary and licensed products address the characteristics
of these patient populations and the shortcomings of available
treatments create opportunities for the development and
commercialization of meaningfully differentiated medicines.
Sympazan®, an oral soluble film formulation of clobazam used for
the treatment of seizures associated with a rare, intractable form
of epilepsy known as Lennox-Gastaut syndrome, or LGS, was approved
by the FDA on November 1, 2018. The Company commercially
launched Sympazan in December 2018. Sympazan was launched as a
precursor and complement to our product candidate Libervant™ and
continues to progress on key performance metrics including
prescriber growth, repeat prescribers, quarterly growth in retail
shipments, and covered lives.
Exservan® (riluzole), utilizing our proprietary PharmFilm
technology, has been developed for the treatment of amyotrophic
lateral sclerosis (ALS). Exservan was approved by the FDA on
November 22, 2019. During the fourth quarter of 2019, we
announced the granting of a license to Zambon S.p.A. for the
development and commercialization of Exservan Oral Film in the
European Union (EU) for treatment of ALS. Zambon is exclusively
responsible for obtaining regulatory approval and marketing
Exservan in the EU and we have sole and exclusive manufacturing
rights for the product in the EU. We are seeking an appropriate
licensee for the commercialization rights for Exservan in the
United States. There can be no assurance that we will be successful
in licensing Exservan in the United States.
One of the company’s out-licensed products, KYNMOBI™, which is used
for the treatment of off episodes in patients suffering from
Parkinson’s disease, was approved by the FDA on May 21, 2020,
and was commercially launched by our licensee in September 2020. In
November 2020, we consummated a royalty monetization transaction
for KYNMOBI™ that will result in proceeds to the Company of up to
$125 million, $50 million of which was received at
closing of the monetization transaction.
Libervant is our most advanced proprietary investigational product
candidate, which we intend to self-commercialize, subject to FDA
approval for market access in the U.S. Libervant is a buccally, or
inside of the cheek, administered soluble film formulation of
diazepam. Aquestive is developing Libervant as an alternative to
the device-dependent rescue therapies currently available to
patients with refractory epilepsy, which are a rectal gel and nasal
sprays. In late September 2020, we received a complete response
letter (“CRL”) from the FDA focusing on dosing issues in certain
weight groups. In a Type A meeting with the FDA in November, the
FDA confirmed that these issues may be addressed by utilizing
modeling and simulations for an updated dosing regimen. The Company
resubmitted a revised weight-based dosing regimen with modeling and
simulations in December 2020. Based upon correspondence from the
FDA, the Company expects to receive feedback and guidance from the
FDA in late January 2021. We expect to resubmit the NDA for
Libervant, based upon further FDA feedback (the timing of which
cannot be assured), during the first half of 2021. We are seeking
to demonstrate to the FDA that Libervant will, if approved by the
FDA, represent a “major contribution to patient care” within the
meaning of FDA regulations and guidance,