Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the
"Company"), a pharmaceutical company advancing medicines to bring
meaningful improvement to patients' lives through innovative
science and delivery technologies, reported financial results for
the third quarter, which ended September 30, 2024, and provided an
update on recent developments in its business.
"Our innovative epinephrine prodrug platform
remains the cornerstone of our development strategy," said Daniel
Barber, President and Chief Executive Officer of Aquestive. "We've
reached a significant milestone with the clinical development
program for Anaphylm, our groundbreaking oral epinephrine treatment
for severe allergic reactions, including anaphylaxis. With our
adult supportive studies now complete, we are preparing for our
pre-NDA meeting for Anaphylm with the FDA scheduled for this
quarter. Moreover, AQST-108, our promising pipeline candidate, is
progressing towards a pre-IND meeting this quarter, setting the
stage for a potential Phase 2a study in alopecia areata next year,
subject to FDA alignment. On the commercial front, we successfully
expanded Libervant's market presence, deploying a dedicated sales
force and securing nationwide reimbursement coverage, positioning
us for continued growth."
Anaphylm™ (epinephrine) Sublingual
FilmAquestive is advancing the development of Anaphylm™
(epinephrine) Sublingual Film, the first and only orally delivered
epinephrine product candidate, as an easy to remember, easy to
carry, and easy to use alternative to EpiPen® and other epinephrine
medical devices for the treatment of severe life-threatening
allergic reactions, including anaphylaxis.
In October 2024, Aquestive reported positive
topline data from the oral allergy syndrome challenge study (now
referred to as the "OASIS" study), meeting both primary and
secondary endpoints. The two-part study demonstrated that Anaphylm
maintained its pharmacokinetics (PK) and pharmacodynamics (PD)
profile during allergen-induced oral physiological changes. In
addition, following allergen exposure where 94% of subjects
exhibited moderate to severe symptoms per the pre-defined oral
severity score, rapid symptom resolution was observed beginning as
early as two minutes after administration of Anaphylm. The median
time to complete symptom resolution was twelve minutes compared to
seventy-four minutes at screening baseline, with 50% of all
symptoms across all subjects resolving by five minutes. The mean
time of symptom resolution for edema, which affected approximately
25% of subjects, was five minutes after Anaphylm administration.
The PK profile remained consistent, with median time to peak drug
concentration (Tmax) maintained at twelve minutes and comparable
geometric mean maximum concentration (Cmax) values between
allergen-exposed and non-exposed cohorts. The safety profile was
favorable, with all adverse events classified as mild to moderate
and resolving without medical intervention.
Also in October 2024, at the American College of
Allergy Asthma and Immunology (ACAAI) 2024 Annual Meeting in
Boston, the Company presented results from a subsequent analysis of
its pivotal study data demonstrating Anaphylm's consistent PK and
PD profile regardless of variable placement or intraoral movement.
The analysis showed that 87.5% of subjects maintained consistent
film placement during disintegration. In the 12.5% of subjects
where movement was noted, there were no significant differences in
Cmax and Tmax. These findings further demonstrate that initial
placement or subsequent movement of the sublingual film had no
impact on epinephrine PK or PD comparability to epinephrine
autoinjectors.
The Company recently received positive pre-New
Drug Application (NDA) written response feedback from the U.S. Food
and Drug Administration (FDA) to the Company's proposed Chemistry,
Manufacturing, Controls (CMC) submission for Anaphylm. In addition,
a clinically focused pre-NDA meeting with the FDA is scheduled for
the fourth quarter of 2024. The Company is maintaining its guidance
of initiating a full product launch of Anaphylm, if approved by the
FDA, in the first quarter of 2026. This is based on commencing the
pediatric study in subjects weighing 30 kgs and above in the fourth
quarter of 2024 and completing an NDA submission with the FDA in
the first quarter of 2025.
AQST-108 (epinephrine) Topical
GelAquestive is advancing the development of AQST-108, a
topically delivered adrenergic agonist prodrug. At the Company's
virtual investor day in September 2024, Aquestive outlined its
development strategy for AQST-108, the second product candidate
from the Company's Adrenaverse prodrug platform. The Company
outlined the design of its planned Phase 2a study to assess the
safety and efficacy of AQST-108 in alopecia areata patients. The
Company has scheduled a pre-IND meeting with the FDA in the fourth
quarter of 2024 to align on the Phase 2a study design and plans to
commence a Phase 2a study in the second quarter of 2025.
An estimated 6.7 million people in the United
States have been affected by alopecia areata. Of those affected,
43% are considered severe. The existing therapies for alopecia
areata are janus kinase (or JAK) inhibitors. These systemic
treatments with known side effects come with a "black box" warning
and are expensive for patients. Even with these limitations, the
estimated market opportunity for JAK inhibitors is over one billion
dollars. In the first in human Phase 1 clinical study, AQST-108
demonstrated no serious adverse events or topical adverse events.
Since AQST-108 is topical and there is evidence that it acts at the
application site, it may not have systemic side effects. As a
result of these conditions, AQST-108, if approved by the FDA as a
treatment for severe alopecia areata, has the potential to capture
significant market share.
Libervant® (diazepam) Buccal
FilmLibervant® (diazepam) Buccal Film is the first and
only FDA approved orally administered rescue product for the
treatment of seizure clusters in patients between the ages of two
and five years.
In April 2024, the FDA approved Libervant for
the acute treatment of intermittent, stereotypic episodes of
frequent seizure activity (i.e., seizure clusters, acute repetitive
seizures) that are distinct from a patient's usual seizure pattern
in patients with epilepsy between the ages of two to five
years.
Aquestive has continued to expand the launch of
Libervant for patients between the ages of two and five years and
currently has a twelve person national sales team in place. Market
access activities have broadened coverage. Libervant for patients
between the ages of two and five years is available nationwide with
retail distribution capabilities in place, is available for
Medicaid patients in this age group in all states, and commercial
access for patients in this age group continues to expand based on
health plan reviews and Pharmacy Benefit Manager agreements.
The NDA for Libervant for the acute treatment of
intermittent, stereotypic episodes of frequent seizure activity
(i.e., seizure clusters, acute repetitive seizures) in patients
twelve years of age and older was tentatively approved by the FDA
in August 2022 and is currently subject to an orphan drug market
exclusivity block until January 2027 based on an FDA approved nasal
spray product of another company. The Company expects to file for
approval of Libervant for the treatment of these epilepsy patients
between six to twelve years of age prior to the expiration of the
orphan drug market exclusivity block.
Commercial
CollaborationsAquestive continues to manufacture products
for the licensing and supply collaborations that it has
established. The Company manufactured approximately 44 million
doses in the third quarter of 2024, compared to approximately 46
million doses in the third quarter of 2023. The Company continues
to support the manufacturing of Indivior's Suboxone® Sublingual
Film product and its other global collaborations, including
Sympazan® (clobazam) Oral Film product for Assertio Holdings, Inc.,
Ondif® (Ondansetron) Oral Film product for Hypera in Brazil, and
Emylif® (Riluzole) Oral Film product for Zambon in Europe.
Sales of royalty-based products, inclusive of
Sympazan® (clobazam) Oral Film for the treatment of seizures
associated with Lennox-Gastaut Syndrome in patients two years of
age and older, and Azstarys® (serdexmethylphenidate and
dexmethylphenidate) for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in patients six years of age and
older, continued to contribute to the Company's revenue in the
third quarter of 2024.
Third Quarter 2024
FinancialsTotal revenues increased to $13.5 million in the
third quarter 2024 from $13.0 million in the third quarter 2023.
This 4% increase in revenue was primarily driven by increases in
license and royalty revenue due to the recognition of deferred
revenue from the termination of a licensing and supply agreement,
partially offset by decreases in manufacture and supply
revenue.
Manufacture and supply revenue decreased to
$10.7 million in the third quarter 2024 from $11.4 million in the
third quarter 2023, primarily due to decreases in Suboxone and
Sympazan revenues, partially offset by an increase in Ondif
revenue, which was attributable to an increase in volume.
Manufacture and supply revenue decreased to $29.3 million for the
nine months ended September 30, 2024 from $32.8 million for
the nine months ended September 30, 2023. On a September
year-to-date basis and excluding the one-time retroactive price
increase of $1.7 million recognized in the three months ended
March 31, 2023, manufacture and supply revenue decreased to $29.3
million from $31.1 million.
Research and development expenses increased to
$5.3 million in the third quarter 2024 from $3.2 million in the
third quarter 2023. The increase in research and development
expenses was primarily due to clinical trial costs and product
research expenses associated with the continued advancement of the
Anaphylm development program.
Selling, general and administrative expenses
increased to $12.1 million in the third quarter 2024 from $7.4
million in the third quarter 2023. This increase was partially
driven by a $1.5 million year-over-year change in the
allocation of expenses of manufacturing and supply costs. Given
this year-over-year change, the Company expects to continue to see
a positive benefit in gross margin offset by somewhat higher
selling, general and administrative expenses. Excluding this item,
increases in expenses were driven by increased commercial spending
and regulatory fees related to the approval of Libervant and the
commercial preparations for Anaphylm.
Aquestive's net loss for the third quarter 2024
was $11.5 million, or $0.13 for both basic and diluted loss per
share, compared to the net loss for the third quarter 2023 of $2.0
million, or $0.03 for both basic and diluted loss per share. The
increase in net loss was primarily driven by increases in selling,
general and administrative expenses, research and development
expenses, non-cash interest expense related to amortization of the
debt and royalty obligation discounts, and decreases in interest
income and other income, net partially offset by increases in
revenues.
Non-GAAP adjusted EBITDA loss was $6.6 million
in the third quarter 2024, compared to non-GAAP adjusted EBITDA
loss of $1.3 million in the third quarter 2023. Non-GAAP adjusted
EBITDA loss excluding adjusted research and development expenses
was $1.6 million in the third quarter 2024, compared to non-GAAP
adjusted EBITDA income excluding adjusted research and development
expenses of $1.7 million in the third quarter 2023.
Cash and cash equivalents were $77.9 million as
of September 30, 2024.
OutlookAquestive's full-year
2024 financial guidance is below.
The Company expects:
|
Guidance |
Total revenue (in
millions) |
$57 to $60 |
Non-GAAP adjusted EBITDA loss
(in millions) |
$20 to $23 |
|
|
Tomorrow’s Conference Call and Webcast
ReminderThe Company will host a conference call at 8:00
a.m. ET on Tuesday, November 5, 2024.
In order to participate, please register in
advance here to obtain a local or toll-free phone number and your
personal pin.
A live webcast of the call will be available on Aquestive’s
website at: Third Quarter 2024 Earnings Call.
About
Anaphylm™Anaphylm™ (epinephrine) Sublingual Film
is a polymer matrix-based epinephrine prodrug product. Anaphylm is
similar in size to a postage stamp, weighs less than an ounce, and
begins to dissolve on contact. No water or swallowing is required
for administration. The primary packaging for Anaphylm is thinner
and smaller than an average credit card, can be carried in a
pocket, and is designed to withstand weather excursions such as
exposure to rain and/or sunlight. The Anaphylm trade name for
AQST-109 has been conditionally approved by the FDA. Final approval
of the Anaphylm proprietary name is conditioned on FDA approval of
the product candidate.
About Libervant®Libervant®
(diazepam) Buccal Film is a buccally, or inside of the cheek,
administered film formulation of diazepam, a benzodiazepine
intended for the acute treatment of intermittent, stereotypic
episodes of frequent seizure activity (i.e., seizure clusters,
acute repetitive seizures) that are distinct from a patient's usual
seizure pattern in patients with epilepsy between two and five
years of age. Aquestive developed Libervant as an alternative to
the device-based products currently available for patients with
refractory epilepsy, including a rectal gel and nasal spray
products. The FDA approval for U.S. market access received in April
2024 for Libervant is for these epilepsy patients between two and
five years of age. The FDA granted tentative approval in August
2022 for Libervant for treatment of these epilepsy patients twelve
years of age and older, with U.S. market access for Libervant for
this age group of patients subject to the expiration of the
existing orphan drug market exclusivity of a previously FDA
approved drug scheduled to expire in January 2027.
About AQST-108AQST-108
(epinephrine) Topical Gel is a topically delivered adrenergic
agonist prodrug gel product candidate. Aquestive completed a first
in human study for AQST-108 that measured the amount of epinephrine
that remained on the skin or was found in circulation over time
after the application of the gel and without any serious or topical
adverse events. AQST-108 is based on Aquestive's Adrenaverse™
platform that contains a library of over twenty epinephrine prodrug
product candidates intended to control absorption and conversion
rates across a variety of possible dosage forms and delivery
sites.
Important Safety InformationDo
not give Libervant to your child between the ages of two and five
if your child is allergic to diazepam or any of the ingredients in
Libervant or has an eye problem called acute narrow angle
glaucoma.
What is the most important information I
should know about Libervant?
- Libervant is a
benzodiazepine medicine. Taking benzodiazepines with opioid
medicines, alcohol, or other central nervous system (CNS)
depressants (including street drugs) can cause severe drowsiness,
breathing problems (respiratory depression), coma, and
death. Get emergency help right away if any of the
following happens:
- shallow or slowed
breathing,
- breathing stops (which may
lead to the heart stopping),
- excessive sleepiness
(sedation).
Do not allow your child to drive a motor
vehicle, operate heavy machinery, or ride a bicycle until you know
how taking Libervant with opioids affects your child.
- Risk of abuse, misuse, and
addiction. Libervant is used in children 2 to 5 years of
age. The unapproved use of Libervant has a risk for abuse, misuse,
and addiction, which can lead to overdose and serious side effects
including coma and death.
- Serious side effects
including coma and death have happened in people who have abused or
misused benzodiazepines, including diazepam (the active ingredient
in Libervant). These serious side effects may also include
delirium, paranoia, suicidal thoughts or actions, seizures, and
difficulty breathing. Call your child's healthcare provider
or go to the nearest hospital emergency room right away if you get
any of these serious side effects.
- Your child can develop an
addiction even if your child takes Libervant as prescribed by your
child's healthcare provider.
- Give Libervant exactly as
your child's healthcare provider prescribed.
- Do not share Libervant with other
people.
- Keep Libervant in a safe place and
away from children.
- Physical dependence and
withdrawal reactions. Libervant is intended for use if needed in
order to treat higher than usual seizure activity.
Benzodiazepines, including Libervant, can cause physical
dependence and withdrawal reactions, especially if used daily.
Libervant is not intended for daily use.
- Do not suddenly stop giving
Libervant to your child without talking to your child's healthcare
provider. Stopping Libervant suddenly can cause serious
and life-threatening side effects, including, unusual movements,
responses, or expressions, seizures that will not stop (status
epilepticus), sudden and severe mental or nervous system changes,
depression, seeing or hearing things that others do not see or
hear, homicidal thoughts, an extreme increase in activity or
talking, losing touch with reality, and suicidal thoughts or
actions. Call your child's healthcare provider or go to the nearest
hospital emergency room right away if your child gets any of these
symptoms.
- Some people who suddenly
stop benzodiazepines have symptoms that can last for several weeks
to more than 12 months including, anxiety, trouble
remembering, learning, or concentrating, depression, problems
sleeping, feeling like insects are crawling under your skin,
weakness, shaking, muscle twitching, burning, or prickling feeling
in your hands, arms, legs or feet, and ringing in your ears.
- Physical dependence is not the same
as drug addiction. Your child's healthcare provider can tell you
more about the differences between physical dependence and drug
addiction.
- Do not give your child more
Libervant than prescribed or give Libervant more often than
prescribed.
Libervant can make your child sleepy or
dizzy and can slow your child's thinking and motor
skills.
- Do not allow your child to drive a
motor vehicle, operate machinery, or ride a bicycle until you know
how Libervant affects your child.
- Do not give other drugs that may
make your child sleepy or dizzy while taking Libervant without
first talking to your child's healthcare provider. When taken with
drugs that cause sleepiness or dizziness, Libervant may make your
child's sleepiness or dizziness much worse.
Like other antiepileptic medicines,
Libervant may cause suicidal thoughts or actions in a small number
of people, about 1 in 500.
- Call a healthcare provider
right away if your child has any of these symptoms, especially if
they are new, worse, or worry you:
- thoughts about suicide or
dying
- new or worse depression
- feeling agitated or restless
- trouble sleeping (insomnia)
- acting aggressive, being angry or
violent
- other unusual changes in behavior
or mood
- attempts to commit suicide
- new or worse anxiety or
irritability
- an extreme increase in activity and
talking (mania)
- new or worse panic attacks
- acting on dangerous impulses
- Pay attention to any changes,
especially sudden changes in mood, behaviors, thoughts, or
feelings.
- Keep all follow-up visits with your
child's healthcare provider as scheduled.
- Call your child's
healthcare provider between visits as needed, especially if you are
worried about symptoms. Suicidal thoughts or actions can
be caused by things other than medicines. If your child has
suicidal thoughts or actions, your child's healthcare provider may
check for other causes.
What are the possible side effects of
Libervant?
- The most common side effects of
Libervant are sleepiness and headache.
- These are not all the possible side
effects of Libervant.
- Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1 800
FDA-1088.
For more information about Libervant, talk to
your doctor, and see Product Information: Medication Guide and
Instructions For Use.
About Aquestive Therapeutics,
Inc.Aquestive is pharmaceutical company advancing
medicines to bring meaningful improvement to patients' lives
through innovative science and delivery technologies. We are
developing orally administered products to deliver complex
molecules, providing novel alternatives to invasive and
inconvenient standard of care therapies. Aquestive has five
commercialized products marketed by the Company and its licensees
in the U.S. and around the world and is the exclusive manufacturer
of these licensed products. The Company also collaborates with
pharmaceutical companies to bring new molecules to market using
proprietary, best-in-class technologies, like PharmFilm®, and has
proven drug development and commercialization capabilities.
Aquestive is advancing a late-stage proprietary product candidate
for the treatment of severe allergic reactions, including
anaphylaxis, and an early-stage epinephrine prodrug topical gel
product candidate for various possible dermatology conditions. For
more information, visit Aquestive.com and follow us on
LinkedIn.
Non-GAAP Financial
InformationThis press release and our webcast earnings
call regarding our quarterly financial results contains financial
measures that do not comply with U.S. generally accepted accounting
principles (GAAP), such as non-GAAP adjusted EBITDA loss, non-GAAP
adjusted gross margins, non-GAAP adjusted costs and expenses and
other adjusted expense measures, because such measures exclude, as
applicable, share-based compensation expense, interest expense,
interest expense related to the sale of future revenue, interest
income, depreciation, amortization, and income taxes.
Specifically, the Company adjusts net income
(loss) for loss on the extinguishment of debt; certain non-cash
expenses, including share-based compensation expenses; depreciation
and amortization; and interest expense related to the sale of
future revenue, interest income and other income (expense), net and
income taxes, with a result of non-GAAP adjusted EBITDA loss.
Similarly, manufacture and supply expense, research and development
expense, and selling, general and administrative expense were
adjusted for certain non-cash expenses of share-based compensation
expense and depreciation and amortization. Non-GAAP adjusted EBITDA
loss and these non-GAAP expense categories are used as a supplement
to the corresponding GAAP measures to provide additional insight
regarding the Company's ongoing operating performance.
These measures supplement the Company's
financial results prepared in accordance with GAAP. Aquestive
management uses these measures to analyze its financial results,
and its future manufacture and supply expenses, gross margins,
research and development expense and selling, general and
administrative expense and to help make managerial decisions. In
management's opinion, these non-GAAP measures provide added
transparency into the operating performance of Aquestive and added
insight into the effectiveness of our operating strategies and
actions. The Company may provide one or more revenue measures
adjusted for certain discrete items, such as fees collected on
certain licensed products, in order to provide investors added
insight into our revenue stream and breakdown, along with providing
our GAAP revenue. Such measures are intended to supplement, not act
as substitutes for, comparable GAAP measures and should not be read
as a measure of liquidity for Aquestive. Non-GAAP adjusted EBITDA
loss and the other non-GAAP measures are also likely calculated in
a way that is not comparable to similarly titled measures reported
by other companies.
Non-GAAP OutlookIn providing
the outlook for non-GAAP adjusted EBITDA and non-GAAP gross margin,
we exclude certain items which are otherwise included in
determining the comparable GAAP financial measures. In order to
inform our outlook measures of non-GAAP adjusted EBITDA and
non-GAAP gross margin, a description of the 2024 and 2023
adjustments which have been applicable in determining non-GAAP
Adjusted EBITDA and non-GAAP gross margin for these periods are
reflected in the tables below. In providing outlook for non-GAAP
gross margin, the Company adjusts for non-cash share-based
compensation expense and depreciation and amortization. The Company
is providing such outlook only on a non-GAAP basis because the
Company is unable to predict with reasonable certainty the totality
or ultimate outcome or occurrence of these adjustments for the
forward-looking period such as share-based compensation expense,
income tax, amortization, and certain other adjusted items, which
can be dependent on future events that may not be reliably
predicted. Based on past reported results, where one or more of
these items have been applicable, such excluded items could be
material, individually or in the aggregate, to reported
results.
Forward-Looking
StatementCertain statements in this press release
include "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 advancement and related timing of our
product candidate Anaphylm™ (epinephrine) Sublingual Film through
clinical development and approval by the U.S. Food and Drug
Administration (FDA), including the timing of submission of
supporting and pediatric clinical studies, holding a pre-New Drug
Application (NDA) meeting with the FDA and filing the NDA for
Anaphylm with the FDA, and the following launch of Anaphylm, if
approved by the FDA; that the results of the Company's clinical
studies for Anaphylm are sufficient to support submission of the
NDA for approval of Anaphylm by the FDA; that Anaphylm will be the
first and only oral administration of epinephrine and accepted as
an alternative to existing standards of care, if Anaphylm is
approved by the FDA; the advancement and related timing of our
Adrenaverse pipeline epinephrine prodrug product candidates,
including AQST-108, through clinical development and FDA regulatory
approval process, including holding a pre-IND meeting with the FDA
for AQST-108; the advancement and related timing of our product
candidate Libervant® (diazepam) Buccal Film for the indicated
epilepsy patient population aged between six and eleven years
through clinical development and FDA regulatory approval and the
following launch of Libervant for this patient population if
approved by the FDA; the approval for U.S. market access of
Libervant for this patient population aged six years, and older and
overcoming the orphan drug market exclusivity of an FDA approved
nasal spray product of another company extending to January 2027
for Libervant for these epilepsy patients six years of age and
older; the advancement, growth and related timing of our
Adrenaverse™ pipeline of epinephrine prodrug product candidates,
including AQST-108 (epinephrine) Topical Gel, through clinical
development including design and timing of clinical studies
including those necessary to support the targeted indication of
alopecia areata for AQST-108, and holding a pre-investigational new
drug application meeting (IND) with the FDA; the commercial
opportunity of Libervant, Anaphylm, AQST-108 and our other product
candidates, including potential revenues (including projected peak
annual sales) generated from commercialization of these products
and product candidates should these product candidates be approved
by the FDA; the potential benefits our products and product
candidates could bring to patients; our cash and financial
position, including with respect to our 2024 financial outlook; and
business strategies, market opportunities, and other statements
that are not historical facts.
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 our development work, including any delays or
changes to the timing, cost and success of our product development
activities and clinical trials and plans, including those relating
to Anaphylm (including for pediatric patients), AQST-108, and the
Company's other product candidates; risks associated with the
Company's distribution work for Libervant, including any delays or
changes to the timing, cost and success of Company's distribution
activities and expansion of market access to patients aged two to
five for Libervant; risk of delays in advancement of the regulatory
approval process through the FDA of our product candidates,
including the filing of the respective NDAs, including for
Anaphylm, AQST-108, Libervant for patients aged between six and
eleven and other product candidates, or failure to receive FDA
approval at all of any of these product candidates; risk of the
Company's ability to generate sufficient clinical data for approval
of our product candidates, including with respect to our PK/PD
comparability submission for FDA approval of Anaphylm; risk of the
Company's ability to address the FDA's comments on the Company's
future clinical trials and other concerns identified in the FDA
Type C meeting minutes for Anaphylm, including the risk that the
FDA may require additional clinical studies for approval of
Anaphylm; risk of the success of any competing products; risk that
we may not overcome the seven year orphan drug market exclusivity
granted by the FDA for the approved nasal spray product of another
company in the U.S. in order for Libervant to be granted U.S.
market access for patients aged six years and older until the
expiration of the orphan drug market exclusivity period of the
nasal spray product due to expire in January 2027, or for other
reasons; risk of loss of U.S. market approval of Libervant for
patients aged between two and five resulting from a legal challenge
relating to U.S. orphan drug market exclusivity by the owner of the
approved nasal spray product with respect to the FDA's approval for
U.S. market access of Libervant for this pediatric patient
population, or for other reasons; risks and uncertainties inherent
in commercializing a new product (including technology risks,
financial risks, market risks and implementation risks and
regulatory limitations); risk of development of a sales and
marketing capability for commercialization of our product Libervant
and other product candidates, including Anaphylm and AQST-108; the
potential impact on the value of the Company of the sale or
outlicensing of our product and product candidates, including
Libervant and Anaphylm and other product candidates; risk of
sufficient capital and cash resources, including sufficient access
to available debt and equity financing, including under our ATM
facility, and revenues from operations, to satisfy all of our
short-term and longer-term liquidity and cash requirements and
other cash needs, at the times and in the amounts needed, including
to fund commercialization activities relating to Libervant for
patients between two and five years of age and to fund future
clinical development and commercial activities for our product
candidates, including Anaphylm, AQST-108 and Libervant for patients
aged between six and eleven, should these product candidates be
approved by the FDA, and for Libervant patients of six years and
older upon expiration of the orphan drug marketing exclusivity
period of the nasal spray product; risk that our manufacturing
capabilities will be sufficient to support demand for Libervant for
patients between two and five years of age and for older patients,
should Libervant receive U.S. market access for these older
patients, and for demand for our licensed products in the U.S. and
abroad; risk of eroding market share for Suboxone® and risk as a
sunsetting product, which accounts for the substantial part of our
current operating revenue; risk of default of our debt instruments;
risks related to the outsourcing of certain sales, marketing and
other operational and staff functions to third parties; risk of the
rate and degree of market acceptance in the U.S. and abroad of
Libervant for epilepsy patients between two and five years of age,
and for older epilepsy patients, if approved for U.S. market access
and after the expiration of the orphan drug market exclusivity
period in January 2027; risk of the rate and degree of market
acceptance in the U.S. and abroad of Libervant and Anaphylm,
AQST-108 and our other product candidates, should these product
candidates be approved by the FDA, and for our licensed products in
the U.S. and abroad; risk of the success of any competing products
including generics; risk of the size and growth of our product
markets; risk 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 our products; risk that our patent applications
for our product candidates, including for Anaphylm, will not be
timely issued, or issued at all, by the PTO; risk of unexpected
patent developments; risk of legislation and regulatory actions and
changes in laws or regulations affecting our business including
relating to our products and products candidates and product
pricing, reimbursement or access therefor; risk of loss of
significant customers; risks related to claims and legal
proceedings against Aquestive including patent infringement,
securities, business torts, investigative, product safety or
efficacy and antitrust litigation matters; risk of product recalls
and withdrawals; risks related to any disruptions in our
information technology networks and systems, including the impact
of cybersecurity attacks; risk of increased cybersecurity attacks
and data accessibility disruptions due to remote working
arrangements; risk of adverse developments affecting the financial
services industry; risks related to inflation and rising interest
rates; risks related to the impact of the COVID-19 global pandemic
and other pandemic diseases on our business, including with respect
to our clinical trials and the site initiation, patient enrollment
and timing and adequacy of those clinical trials, regulatory
submissions and regulatory reviews and approvals of our product
candidates, availability of pharmaceutical ingredients and other
raw materials used in our products and product candidates, supply
chain, manufacture and distribution of our products and product
candidates; risks and uncertainties related to general economic,
political (including the Ukraine and Israel wars and other acts of
war and terrorism), business, industry, regulatory, financial and
market conditions and other unusual items. These forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause our actual results, levels of activity,
performance or achievements to differ materially from those
expressed or implied by these statements. These factors include the
matters discussed and referenced in the risk factors of the
Company's 2023 Annual Report on Form 10-K and our other Quarterly
Reports on Form 10-Q and in our Current Reports on Form 8-K and our
other filings with the U.S. Securities and Exchange Commission.
Given these uncertainties, you should not place undue reliance on
these forward-looking statements, which speak only as the date
made. All subsequent forward-looking statements attributable to the
Company or any person acting on its 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.
Libervant®, 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:ICR WestwickeStephanie
CarringtonStephanie.Carrington@icrhealthcare.com646-277-1282
|
AQUESTIVE THERAPEUTICS, INC. |
Condensed Balance Sheets |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
September 30,2024 |
|
December 31,2023 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
77,893 |
|
|
$ |
23,872 |
|
Trade and other receivables, net |
|
|
9,684 |
|
|
|
8,471 |
|
Inventories |
|
|
7,021 |
|
|
|
6,769 |
|
Prepaid expenses and other current assets |
|
|
1,972 |
|
|
|
1,854 |
|
Total current assets |
|
|
96,570 |
|
|
|
40,966 |
|
Property and equipment, net |
|
|
3,848 |
|
|
|
4,179 |
|
Right-of-use assets, net |
|
|
5,310 |
|
|
|
5,557 |
|
Intangible assets, net |
|
|
— |
|
|
|
1,278 |
|
Other non-current assets |
|
|
4,230 |
|
|
|
5,438 |
|
Total assets |
|
$ |
109,958 |
|
|
$ |
57,418 |
|
|
|
|
|
|
Liabilities and
stockholders' deficit |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
7,572 |
|
|
$ |
8,926 |
|
Accrued expenses |
|
|
5,025 |
|
|
|
6,497 |
|
Lease liabilities, current |
|
|
482 |
|
|
|
390 |
|
Deferred revenue, current |
|
|
1,048 |
|
|
|
1,551 |
|
Liability related to the sale of future revenue, current |
|
|
1,000 |
|
|
|
922 |
|
Loans payable, current |
|
|
25 |
|
|
|
22 |
|
Total current liabilities |
|
|
15,152 |
|
|
|
18,308 |
|
Notes payable, net |
|
|
31,253 |
|
|
|
27,508 |
|
Royalty obligations, net |
|
|
18,835 |
|
|
|
14,761 |
|
Liability related to the sale of future revenue, net |
|
|
62,730 |
|
|
|
63,568 |
|
Lease liabilities |
|
|
5,109 |
|
|
|
5,399 |
|
Deferred revenue, net of current portion |
|
|
20,266 |
|
|
|
32,345 |
|
Other non-current liabilities |
|
|
2,033 |
|
|
|
2,016 |
|
Total liabilities |
|
|
155,378 |
|
|
|
163,905 |
|
Contingencies |
|
|
|
|
|
|
|
|
|
Stockholders' deficit: |
|
|
|
|
Common stock, $0.001 par value. Authorized 250,000,000 shares;
91,178,193 and 68,533,085 shares issued and outstanding at
September 30, 2024 and December 31, 2023, respectively |
|
|
91 |
|
|
|
69 |
|
Additional paid-in capital |
|
|
300,648 |
|
|
|
212,521 |
|
Accumulated deficit |
|
|
(346,159 |
) |
|
|
(319,077 |
) |
Total stockholders' deficit |
|
|
(45,420 |
) |
|
|
(106,487 |
) |
Total liabilities and stockholders' deficit |
|
$ |
109,958 |
|
|
$ |
57,418 |
|
AQUESTIVE THERAPEUTICS, INC. |
Condensed Statements of Operations and Comprehensive (Loss)
Income |
(In thousands, except share and per share data
amounts) |
(Unaudited) |
|
|
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember
30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenues |
|
$ |
13,542 |
|
|
$ |
13,002 |
|
|
$ |
45,694 |
|
|
$ |
37,377 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Manufacture and supply |
|
|
4,437 |
|
|
|
4,798 |
|
|
|
13,352 |
|
|
|
16,152 |
|
Research and development |
|
|
5,269 |
|
|
|
3,196 |
|
|
|
15,363 |
|
|
|
10,216 |
|
Selling, general and administrative |
|
|
12,126 |
|
|
|
7,385 |
|
|
|
34,171 |
|
|
|
22,200 |
|
Total costs and expenses |
|
|
21,832 |
|
|
|
15,379 |
|
|
|
62,886 |
|
|
|
48,568 |
|
Income (Loss) from operations |
|
|
(8,290 |
) |
|
|
(2,377 |
) |
|
|
(17,192 |
) |
|
|
(11,191 |
) |
Other income/(expenses): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2,780 |
) |
|
|
(1,256 |
) |
|
|
(8,343 |
) |
|
|
(4,064 |
) |
Interest expense related to royalty obligations |
|
|
(1,359 |
) |
|
|
— |
|
|
|
(4,075 |
) |
|
|
— |
|
Interest expense related to the sale of future revenue |
|
|
(59 |
) |
|
|
(56 |
) |
|
|
(175 |
) |
|
|
(163 |
) |
Interest income and other income, net |
|
|
979 |
|
|
|
1,514 |
|
|
|
2,703 |
|
|
|
16,156 |
|
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(353 |
) |
Net (loss) income before
income taxes |
|
|
(11,509 |
) |
|
|
(2,175 |
) |
|
|
(27,082 |
) |
|
|
385 |
|
Income taxes (benefit) expense |
|
|
— |
|
|
|
(140 |
) |
|
|
— |
|
|
|
144 |
|
Net (loss) income |
|
$ |
(11,509 |
) |
|
$ |
(2,035 |
) |
|
$ |
(27,082 |
) |
|
$ |
241 |
|
Comprehensive (loss)
income |
|
$ |
(11,509 |
) |
|
$ |
(2,035 |
) |
|
$ |
(27,082 |
) |
|
$ |
241 |
|
|
|
|
|
|
|
|
|
|
(Loss) earnings per
share attributable to common stockholders: |
|
|
|
|
|
|
|
|
Basic (in dollars per
share) |
|
$ |
(0.13 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.32 |
) |
|
$ |
— |
|
Diluted (in dollars per
share) |
|
$ |
(0.13 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.32 |
) |
|
$ |
— |
|
Weighted average
common shares outstanding: |
|
|
|
|
|
|
|
|
Basic (in shares) |
|
|
91,082,081 |
|
|
|
64,678,761 |
|
|
|
85,224,263 |
|
|
|
59,252,768 |
|
Diluted (in shares) |
|
|
91,082,081 |
|
|
|
64,678,761 |
|
|
|
85,224,263 |
|
|
|
61,513,736 |
|
AQUESTIVE THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments – Net (Loss) Income
to Non-GAAP Adjusted EBITDA |
(In Thousands) |
(Unaudited) |
|
|
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember
30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP net (loss) income |
|
$ |
(11,509 |
) |
|
$ |
(2,035 |
) |
|
$ |
(27,082 |
) |
|
$ |
241 |
|
Share-based compensation expense |
|
|
1,577 |
|
|
|
774 |
|
|
|
4,696 |
|
|
|
1,766 |
|
Interest expense |
|
|
2,780 |
|
|
|
1,256 |
|
|
|
8,343 |
|
|
|
4,064 |
|
Interest expense related to royalty obligations |
|
|
1,359 |
|
|
|
— |
|
|
|
4,075 |
|
|
|
— |
|
Interest expense related to the sale of future revenue |
|
|
59 |
|
|
|
56 |
|
|
|
175 |
|
|
|
163 |
|
Interest income and other income, net |
|
|
(979 |
) |
|
|
(1,514 |
) |
|
|
(2,703 |
) |
|
|
(16,156 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
353 |
|
Income Taxes |
|
|
— |
|
|
|
(140 |
) |
|
|
— |
|
|
|
144 |
|
Depreciation and Amortization |
|
|
159 |
|
|
|
264 |
|
|
|
571 |
|
|
|
878 |
|
Total non-GAAP
adjustments |
|
$ |
4,955 |
|
|
$ |
696 |
|
|
$ |
15,157 |
|
|
$ |
(8,788 |
) |
Non-GAAP adjusted EBITDA |
|
$ |
(6,554 |
) |
|
$ |
(1,339 |
) |
|
$ |
(11,925 |
) |
|
$ |
(8,547 |
) |
Excluding Non-GAAP adjusted
R&D expenses |
|
|
(4,943 |
) |
|
|
(3,069 |
) |
|
|
(14,521 |
) |
|
|
(9,869 |
) |
Non-GAAP adjusted EBITDA
excluding Non-GAAP adjusted R&D expenses |
|
$ |
(1,611 |
) |
|
$ |
1,730 |
|
|
$ |
2,596 |
|
|
$ |
1,322 |
|
AQUESTIVE THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments – GAAP Expenses to
Non-GAAP Adjusted Expenses |
(In Thousands, except percentages) |
(Unaudited) |
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Total costs and
expenses |
|
$ |
21,832 |
|
|
$ |
15,379 |
|
|
$ |
62,886 |
|
|
$ |
48,568 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
(1,577 |
) |
|
|
(774 |
) |
|
|
(4,696 |
) |
|
|
(1,766 |
) |
Depreciation and amortization |
|
|
(159 |
) |
|
|
(264 |
) |
|
|
(571 |
) |
|
|
(878 |
) |
Non-GAAP adjusted
costs and expenses |
|
$ |
20,096 |
|
|
$ |
14,341 |
|
|
$ |
57,619 |
|
|
$ |
45,924 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacture and Supply
Expense |
|
$ |
4,437 |
|
|
$ |
4,798 |
|
|
$ |
13,352 |
|
|
$ |
16,152 |
|
Gross Margin on total revenue |
|
|
67 |
% |
|
|
63 |
% |
|
|
71 |
% |
|
|
57 |
% |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
(102 |
) |
|
|
(59 |
) |
|
|
(271 |
) |
|
|
(155 |
) |
Depreciation and amortization |
|
|
(130 |
) |
|
|
(214 |
) |
|
|
(482 |
) |
|
|
(746 |
) |
Non-GAAP adjusted
manufacture and supply expense |
|
$ |
4,205 |
|
|
$ |
4,525 |
|
|
$ |
12,599 |
|
|
$ |
15,251 |
|
Non-GAAP Gross Margin on total revenue |
|
|
69 |
% |
|
|
65 |
% |
|
|
72 |
% |
|
|
59 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
Development Expense |
|
$ |
5,269 |
|
|
$ |
3,196 |
|
|
$ |
15,363 |
|
|
$ |
10,216 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
(310 |
) |
|
|
(105 |
) |
|
|
(788 |
) |
|
|
(277 |
) |
Depreciation and amortization |
|
|
(16 |
) |
|
|
(22 |
) |
|
|
(54 |
) |
|
|
(70 |
) |
Non-GAAP adjusted
research and development expense |
|
$ |
4,943 |
|
|
$ |
3,069 |
|
|
$ |
14,521 |
|
|
$ |
9,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, General and
Administrative Expenses |
|
$ |
12,126 |
|
|
$ |
7,385 |
|
|
$ |
34,171 |
|
|
$ |
22,200 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
(1,165 |
) |
|
|
(610 |
) |
|
|
(3,637 |
) |
|
|
(1,334 |
) |
Depreciation and amortization |
|
|
(13 |
) |
|
|
(28 |
) |
|
|
(35 |
) |
|
|
(62 |
) |
Non-GAAP adjusted
selling, general and administrative expenses |
|
$ |
10,948 |
|
|
$ |
6,747 |
|
|
$ |
30,499 |
|
|
$ |
20,804 |
|
Aquestive Therapeutics (NASDAQ:AQST)
過去 株価チャート
から 11 2024 まで 12 2024
Aquestive Therapeutics (NASDAQ:AQST)
過去 株価チャート
から 12 2023 まで 12 2024