Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical
company advancing medicines to bring meaningful improvement to
patients' lives through innovative science and delivery
technologies, today reported financial results for the fourth
quarter and full year ended December 31, 2023, and provided a
progress update on the key 2024 objectives previously outlined by
the Company.
“We ended 2023 on a strong note with double
digit base revenue growth, an improved balance sheet, and the start
of our pivotal study for Anaphylm. We are now focused on continuing
our progress in 2024 and building a strong foundation for the
long-term growth of the Company. This includes (1) progressing
Anaphylm to a US filing, (2) expanding and growing our revenue
base, (3) licensing or launching Libervant (diazepam) Buccal Film,
if approved by the FDA with market access, and (4) advancing our
next pipeline assets by utilizing our Adrenaverse technology,”
stated Daniel Barber, President and Chief Executive Officer of
Aquestive. “Anaphylm, as the only orally administered epinephrine
product under development for the treatment of severe allergic
reactions including anaphylaxis, continues to represent a
transformational opportunity for both patients and the Company. We
remain excited to see our topline pivotal data and continue to
anticipate reporting topline data from our Anaphylm pivotal study
this month.”
Anaphylm™Aquestive is advancing
the development of Anaphylm, the first and only orally delivered
epinephrine product candidate to demonstrate clinical results
comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the
emergency treatment of allergic reactions, including
anaphylaxis.
Aquestive received positive feedback in October
2023 from the U.S. Food and Drug Administration (FDA) on the
Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol
for Anaphylm. The FDA indicated that the Company’s proposed
endpoints, sample size, and statistical analysis are reasonable. As
anticipated, the FDA also reminded the Company that PK
sustainability post-dosing (30–60 minutes) is an important factor
and recommended using repeat-dose data to support PK
sustainability. The Company has incorporated the FDA’s feedback
into the design of its clinical protocol for Anaphylm.
Aquestive commenced dosing in December 2023 in
the Phase 3 pivotal PK clinical study of Anaphylm. The two-part,
single-center, open-label, randomized study is designed to compare
the PK and pharmacodynamics (PD) of single and repeat doses of
Anaphylm versus single and repeat doses of the epinephrine IM
injection and epinephrine autoinjectors in healthy adult subjects.
The primary objective of the study is to compare the PK of
epinephrine following the single administration of Anaphylm to
single administration of epinephrine IM injection in healthy adult
subjects. The secondary objectives of the study include evaluating
PK sustainability following repeat administration and evaluating
the safety and tolerability following single and repeat
administrations versus epinephrine IM injection and epinephrine
autoinjectors. Aquestive anticipates reporting topline data from
the Anaphylm Pivotal PK study this month and continuing to guide to
a filing of the Anaphylm New Drug Application (NDA) with the FDA
before the end of 2024. A comprehensive adult and pediatric Human
Factors program, an expected and ongoing part of the Anaphylm
clinical development program, will also be included in the Anaphylm
NDA to support future labeling and the use of the product by
intended patients.
Libervant™In September 2023,
the FDA accepted Aquestive's NDA for Libervant (diazepam) Buccal
Film for the acute treatment of intermittent, stereotypic episodes
of frequent seizure activity (i.e., seizure clusters, acute
repetitive seizures) in patients between two and five years of age.
Diastat (diazepam) Rectal Gel is the only FDA approved treatment
currently available to this patient population for this indication.
Based on the latest information available to the Company, the
review of the Libervant NDA remains on track and there are
currently no outstanding information requests from the FDA. The NDA
for Libervant was assigned a PDUFA target action date of April 28,
2024.
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 continues to engage with the FDA on
Libervant’s approval for U.S. market access and remains committed
to bringing Libervant to patients.
Commercial
CollaborationsAquestive continues to manufacture products
for the licensing and supply collaborations that it has
established. The Company manufactured approximately 45 million
doses in the fourth quarter 2023, compared to approximately 37
million doses in the fourth quarter 2022. The Company continues to
see consistent order demand for the manufacture of Indivior’s
Suboxone® Sublingual Film product and continues to support its
other global collaborations including the recent launch of Emilyf
(Riluzole) Oral Film product by 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® for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in patients six years of age and
older continued to improve in the fourth quarter of 2023.
Fourth Quarter 2023
FinancialsTotal revenues were $13.2 million in the fourth
quarter 2023, compared to $10.7 million in the fourth quarter 2022,
an increase of 24%. The increase was due to higher manufacture and
supply revenues, and license and royalty revenues, offset by the
discontinuance of proprietary product sales of Sympazan as a result
of the outlicensing agreement with Assertio in October 2022.
Manufacture and supply revenue increased by 23%,
or $2.1 million, primarily due to increased manufacturing revenues
of $3.2 million for Suboxone partially offset by decreases for
Ondif® for Hypera in Brazil and for Sympazan.
In addition, the Company recognized $1.0 million
in milestone royalty revenue for Azstarys from Zevra
Therapeutics.
Aquestive’s net loss for the fourth quarter 2023
was $8.1 million, or $0.12 loss per share. The net loss for the
fourth quarter 2022 was $12.4 million, or $0.23 loss per share. The
reduction in net loss was primarily driven by increases in revenue
described above, decreases in selling, general and administrative
expense, including severance costs and lower administrative costs
in the commercial organization subsequent to the outlicensing of
Sympazan, and a decrease in research and development cost and
expenses, partially offset by increases by a one-time loss on
extinguishment of debt of $1.0 million and higher interest expense
related to the amortization of debt discount related to the 13.5%
Notes payable.
Non-GAAP adjusted EBITDA loss was $2.8 million
in the fourth quarter 2023, compared to a $9.6 million loss in the
fourth quarter 2022. Non-GAAP adjusted EBITDA loss excluding
adjusted R&D expenses was $0.1 million in the fourth quarter
2023, compared to a non-GAAP adjusted EBITDA loss excluding
adjusted R&D expenses of $5.6 million in the fourth quarter
2022.
Full Year 2023
FinancialsExcluding the impact of prior year proprietary
sales of Sympazan, total revenues increased from $40.0 million for
the full year 2022 to $50.6 million for the full year 2023, an
increase of 26%. The increase was due to higher manufacture and
supply revenues and license and royalty revenue offset by the
discontinuance of proprietary product sales of Sympazan following
the outlicensing of Sympazan.
Total reported revenues were $50.6 million for
the full year 2023, compared to $47.7 million for the full year
2022, an increase of 6%.
Manufacture and supply revenue increased 20% due
to increased manufacturing revenues of $4.4 million for Suboxone,
increased revenues of $2.1 million for Ondif for Hypera subsequent
to receiving foreign regulatory approval in February 2022, and
increased revenues of $0.6 million for Sympazan.
License and royalty revenue increased 129%, or
$3.0 million, for the year ended December 31, 2023 compared to
the same period in 2022. This increase was primarily due to $1.5
million in milestone licensing revenues for Azstarys from Zevra
Therapeutics and increased licensing and royalty revenue of $1.3
million for Sympazan.
The Company’s net loss for the full year 2023
was $7.9 million, or $0.13 loss per share. The net loss for the
full year 2022 was $54.4 million, or $1.12 loss per share. The
reduction in net loss was primarily driven by $14.5 million of
other income which consisted of $6.0 million from an amendment to
the Indivior Commercial Exploitation Agreement, and $8.5 million
from the patent litigation settlement with BioDelivery Sciences
International, increases in revenue described above, decrease in
selling, general and administrative expense, including severance
costs and significantly lower administrative costs in the
commercial organization subsequent to the outlicensing of Sympazan,
a decrease in research and development cost and expenses and lower
interest expense related to the KYNMOBI® monetization transaction,
partially offset by a loss on extinguishment of debt of $1.4
million and higher interest expense related to the amortization of
debt discount related to the 13.5% Notes payable.
Non-GAAP adjusted EBITDA loss was $11.6 million
in the full year 2023, compared to a loss of $35.3 million in the
full year 2022. The year-over-year change in non-GAAP adjusted
EBITDA was primarily driven by the items described above. Non-GAAP
adjusted EBITDA income excluding adjusted R&D expenses was $1.0
million in the full year 2023, compared to a non-GAAP adjusted
EBITDA loss excluding adjusted R&D expenses of $18.7 million in
the full year 2022.
As of December 31, 2023, cash and cash
equivalents were $23.9 million. During the fourth quarter 2023,
the Company accessed capital net proceeds of $3.7 million under its
"At-the-Market" (ATM) facility.
2024
Outlook
Aquestive is providing its full year 2024
financial outlook. The Company expects:
|
Guidance |
Total revenue (in millions) |
$48 to $51 |
Non-GAAP adjusted EBITDA loss (in
millions) |
$22 to $26 |
|
|
Revenue guidance does not include any revenue
for Libervant. In addition, the guidance for 2024 includes
continued focused R&D investments related to the continued
development and planned NDA filing of Anaphylm.
Tomorrow’s Conference Call and Webcast
ReminderThe Company will host a conference call at 8:00
a.m. ET on Wednesday, March 6, 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: Fourth Quarter 2023 Earnings Call. The webcast will be
archived for 30 days.
About Aquestive
TherapeuticsAquestive is a 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 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 pipeline
focused on treating diseases of the central nervous system and an
earlier stage pipeline for the treatment of severe allergic
reactions, including anaphylaxis. 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 EBITDA loss excluding adjusted R&D expenses, 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 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. 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. 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 Outlook
In 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
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 through clinical development and
approval by the FDA, including receipt and release of topline data
and the filing of the Anaphylm NDA; regarding the FDA’s approval
and related timing of the filing of the NDA for Libervant with the
FDA 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 between two and five years of age;
regarding the approval for U.S. market access of Libervant for
these epilepsy patients aged two years and older; overcoming the
orphan drug market exclusivity of an FDA approved nasal spray
product of another company extending to January 2027 for this
patient population; regarding the potential benefits Anaphylm and
Libervant could bring to patients; regarding the potential growth
in market demand for existing licensed products of the Company in
the U.S. and abroad and the potential and related timing for
expanding the Company’s manufacturing capabilities and supporting
the growth of demand for existing and potential future licensed
products in the U.S. and other countries; regarding the financial
outlook of the Company and its growth and future financial and
operating results and financial position; regarding advancing the
Company's pipeline assets utilizing the Company's Adrenaverse
technology through clinical development and regulatory approval;
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 the Company’s business including
with respect to its clinical trials including site initiation,
enrollment and timing and adequacy of clinical trials; on
regulatory submissions and regulatory reviews and approval of
Anaphylm and Libervant and the Company's other pipeline products,
pharmaceutical ingredients and other raw materials supply chain,
manufacture, and distribution; and ongoing availability of an
appropriate labor force and skilled professionals.
These forward-looking statements are based on
the Company’s 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
its product development activities and clinical trials for
Anaphylm, Libervant and our other product candidates; risk of the
Company’s ability to generate sufficient data in its 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
pivotal PK study protocol and other concerns identified in the FDA
End-of-Phase 2 meeting for Anaphylm, including the risk that the
FDA may require additional clinical studies for approval of
Anaphylm; risk of delays in or the failure to receive FDA approval
of Anaphylm; risks that the FDA will not approve Libervant for U.S.
market access by overcoming the seven year orphan drug market
exclusivity of an FDA approved nasal spray product of another
company in effect until January 2027; risk of delays in or the
failure to receive FDA approval of the NDA for Libervant for these
epilepsy patients between two and five years of age, including the
risk that the FDA may require additional clinical studies for
approval of Libervant for this age group, and there can be no
assurance that the Company will be successful in obtaining any of
the foregoing FDA approvals for Anaphylm and Libervant, including
for U.S. market access for Libervant for any age group of patients;
risk that a competing pediatric epilepsy product of Libervant will
receive FDA approval prior to the Company’s receipt of FDA approval
of the Libervant NDA for these epilepsy patients between two and
five years of age; risk relating to the unpredictability of the
FDA’s decisions regarding orphan drug exclusivity; risk of
litigation brought by third parties relating to overcoming their
orphan drug exclusivity of an FDA approved product should the FDA
approve Libervant for U.S. market access for any age group of this
epilepsy patient population; risk in obtaining market access for
Libervant for other reasons; 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;
risk of the success of any competing products; risk inherent in
commercializing a new product (including technology risks,
financial risks, market risks and implementation risks, and
regulatory limitations); risk of the rate and degree of market
acceptance of our product candidates, including Anaphylm and
Libervant, and our licensed products in the U.S. and abroad; risk
of insufficient capital and cash resources, including insufficient
access to available debt and equity financing and revenues from
operations, to satisfy all of the Company’s short-term and longer
term liquidity and cash requirements and other cash needs, at the
times and in the amounts needed, including to fund future clinical
development activities for Anaphylm, Libervant and our other
product candidates; risk of failure to satisfy all financial and
other debt covenants and of any default under existing debt
financing; risk that our manufacturing capabilities will be
sufficient to support demand for existing and potential future
licensed products in the U.S. and other countries; 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 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;
uncertainties related to general economic, political (including
acts of war and terrorism), business, industry, regulatory,
financial and market conditions and other unusual items; and other
risks and uncertainties affecting the Company described in the
“Risk Factors” section and in other sections included in the
Company’s 10-K, Quarterly Reports on Form 10-Q, and Current Reports
on Form 8-K filed with the U.S. Securities and Exchange Commission.
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 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.
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@westwicke.com646-277-1282
AQUESTIVE THERAPEUTICS, INC. |
Consolidated Balance Sheets |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
December 31, |
|
2023 |
|
2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
23,872 |
|
|
$ |
27,273 |
|
Trade and other receivables, net |
|
8,471 |
|
|
|
4,704 |
|
Inventories, net |
|
6,769 |
|
|
|
5,780 |
|
Prepaid expenses and other current assets |
|
1,854 |
|
|
|
2,131 |
|
Total current assets |
|
40,966 |
|
|
|
39,888 |
|
Property and equipment,
net |
|
4,179 |
|
|
|
4,085 |
|
Right-of-use assets, net |
|
5,557 |
|
|
|
5,211 |
|
Intangible assets, net |
|
1,278 |
|
|
|
1,435 |
|
Other non-current assets |
|
5,438 |
|
|
|
6,451 |
|
Total assets |
$ |
57,418 |
|
|
$ |
57,070 |
|
|
|
|
|
Liabilities and
stockholders’ deficit |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
8,926 |
|
|
$ |
9,946 |
|
Accrued expenses |
|
6,497 |
|
|
|
7,967 |
|
Lease liabilities, current |
|
390 |
|
|
|
255 |
|
Deferred revenue |
|
1,551 |
|
|
|
1,513 |
|
Liability related to the sale of future revenue, current |
|
922 |
|
|
|
1,147 |
|
Loans payable, current |
|
22 |
|
|
|
18,700 |
|
Total current liabilities |
|
18,308 |
|
|
|
39,528 |
|
Loans payable, net |
|
27,508 |
|
|
|
33,448 |
|
Royalty obligations, net |
|
14,761 |
|
|
|
— |
|
Liability related to the sale of future revenue, net |
|
63,568 |
|
|
|
64,112 |
|
Lease liabilities |
|
5,399 |
|
|
|
5,085 |
|
Deferred revenue, net of current portion |
|
32,345 |
|
|
|
31,417 |
|
Other non-current liabilities |
|
2,016 |
|
|
|
2,034 |
|
Total liabilities |
|
163,905 |
|
|
|
175,624 |
|
Contingencies |
|
|
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
Common stock, $0.001 par value. Authorized 250,000,000 shares;
68,533,085 and 54,827,734 shares issued and outstanding at
December 31, 2023 and December 31, 2022,
respectively |
|
69 |
|
|
|
55 |
|
Additional paid-in capital |
|
212,521 |
|
|
|
192,598 |
|
Accumulated deficit |
|
(319,077 |
) |
|
|
(311,207 |
) |
Total stockholders’ deficit |
|
(106,487 |
) |
|
|
(118,554 |
) |
Total liabilities and stockholders’ deficit |
$ |
57,418 |
|
|
$ |
57,070 |
|
|
|
|
|
|
|
|
|
AQUESTIVE THERAPEUTICS, INC. |
Consolidated Statements of Operations and Comprehensive
Loss |
(In thousands, except share and per share data
amounts) |
(Unaudited) |
|
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues |
$ |
13,206 |
|
|
$ |
10,682 |
|
|
$ |
50,583 |
|
|
$ |
47,680 |
|
Costs and expenses: |
|
|
|
|
|
|
|
Manufacture and supply |
|
4,679 |
|
|
|
5,305 |
|
|
|
20,831 |
|
|
|
19,386 |
|
Research and development |
|
2,888 |
|
|
|
4,278 |
|
|
|
13,104 |
|
|
|
17,481 |
|
Selling, general and administrative |
|
9,550 |
|
|
|
11,812 |
|
|
|
31,750 |
|
|
|
52,879 |
|
Total costs and expenses |
|
17,117 |
|
|
|
21,395 |
|
|
|
65,685 |
|
|
|
89,746 |
|
Loss from operations |
|
(3,911 |
) |
|
|
(10,713 |
) |
|
|
(15,102 |
) |
|
|
(42,066 |
) |
Other income (expenses): |
|
|
|
|
|
|
|
Interest expense |
|
(2,273 |
) |
|
|
(1,650 |
) |
|
|
(6,337 |
) |
|
|
(6,552 |
) |
Interest expense related to royalty obligations |
|
(905 |
) |
|
|
— |
|
|
|
(905 |
) |
|
|
— |
|
Interest expense related to the sale of future revenue |
|
(57 |
) |
|
|
(54 |
) |
|
|
(220 |
) |
|
|
(5,891 |
) |
Interest income and other income, net |
|
165 |
|
|
|
65 |
|
|
|
16,321 |
|
|
|
99 |
|
Loss on the extinguishment of debt |
|
(1,029 |
) |
|
|
— |
|
|
|
(1,382 |
) |
|
|
— |
|
Net loss before income taxes |
|
(8,010 |
) |
|
|
(12,352 |
) |
|
|
(7,625 |
) |
|
|
(54,410 |
) |
Income taxes |
|
(101 |
) |
|
|
— |
|
|
|
(245 |
) |
|
|
— |
|
Net loss |
$ |
(8,111 |
) |
|
$ |
(12,352 |
) |
|
$ |
(7,870 |
) |
|
$ |
(54,410 |
) |
Comprehensive loss |
$ |
(8,111 |
) |
|
$ |
(12,352 |
) |
|
$ |
(7,870 |
) |
|
$ |
(54,410 |
) |
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.12 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.13 |
) |
|
$ |
(1.12 |
) |
|
|
|
|
|
|
|
|
Weighted-average number of
common shares outstanding - basic and diluted |
|
67,199,645 |
|
|
|
54,390,696 |
|
|
|
61,255,864 |
|
|
|
48,734,377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - Net Loss to
Adjusted EBITDA |
(In
Thousands) |
(Unaudited) |
|
|
|
|
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
GAAP net loss |
$ |
(8,111 |
) |
|
$ |
(12,352 |
) |
|
$ |
(7,870 |
) |
|
$ |
(54,410 |
) |
Share-based compensation expense |
|
923 |
|
|
|
712 |
|
|
|
2,689 |
|
|
|
4,381 |
|
Interest expense |
|
2,273 |
|
|
|
1,650 |
|
|
|
6,337 |
|
|
|
6,552 |
|
Interest expense related to the sale of future revenue |
|
57 |
|
|
|
54 |
|
|
|
220 |
|
|
|
5,891 |
|
Interest expense related to royalty obligations |
|
905 |
|
|
|
— |
|
|
|
905 |
|
|
|
— |
|
Interest income and other income (expense), net |
|
(165 |
) |
|
|
(65 |
) |
|
|
(16,321 |
) |
|
|
(99 |
) |
Income taxes |
|
(101 |
) |
|
|
— |
|
|
|
(245 |
) |
|
|
— |
|
Depreciation, amortization, and impairment |
|
433 |
|
|
|
397 |
|
|
|
1,345 |
|
|
|
2,387 |
|
Loss on extinguishment of debt |
|
1,029 |
|
|
|
— |
|
|
|
1,382 |
|
|
|
— |
|
Total non-GAAP
adjustments |
$ |
5,354 |
|
|
$ |
2,748 |
|
|
$ |
(3,688 |
) |
|
$ |
19,112 |
|
Adjusted EBITDA |
$ |
(2,757 |
) |
|
$ |
(9,604 |
) |
|
$ |
(11,558 |
) |
|
$ |
(35,298 |
) |
Excluding adjusted R&D
expenses |
$ |
(2,688 |
) |
|
$ |
(3,975 |
) |
|
$ |
(12,557 |
) |
|
$ |
(16,636 |
) |
Adjusted EBITDA excluding
adjusted R&D expenses |
$ |
(69 |
) |
|
$ |
(5,629 |
) |
|
$ |
999 |
|
|
$ |
(18,662 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - Total Costs and
Expenses to Adjusted Costs and Expenses |
(In
Thousands) |
(Unaudited) |
|
|
|
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Total costs and expenses |
$ |
17,117 |
|
|
$ |
21,395 |
|
|
$ |
65,685 |
|
|
$ |
89,746 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
|
(923 |
) |
|
|
(712 |
) |
|
|
(2,689 |
) |
|
|
(4,381 |
) |
Depreciation, amortization, and impairment |
|
(433 |
) |
|
|
(397 |
) |
|
|
(1,345 |
) |
|
|
(2,387 |
) |
Adjusted costs and
expenses |
$ |
15,761 |
|
|
$ |
20,286 |
|
|
$ |
61,651 |
|
|
$ |
82,978 |
|
Manufacture and supply expense |
$ |
4,679 |
|
|
$ |
5,305 |
|
|
$ |
20,831 |
|
|
$ |
19,386 |
|
Gross Margin on total revenue |
|
65 |
% |
|
|
50 |
% |
|
|
59 |
% |
|
|
59 |
% |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
|
(36 |
) |
|
|
(44 |
) |
|
|
(191 |
) |
|
|
(203 |
) |
Depreciation, amortization, and impairment |
|
(395 |
) |
|
|
(317 |
) |
|
|
(1,140 |
) |
|
|
(1,890 |
) |
Adjusted manufacture and
supply expense |
$ |
4,248 |
|
|
$ |
4,944 |
|
|
$ |
19,500 |
|
|
$ |
17,293 |
|
Non-GAAP Gross Margin on total revenue |
|
68 |
% |
|
|
54 |
% |
|
|
61 |
% |
|
|
64 |
% |
Research and development expense |
$ |
2,888 |
|
|
$ |
4,278 |
|
|
$ |
13,104 |
|
|
$ |
17,481 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
|
(179 |
) |
|
|
(266 |
) |
|
|
(456 |
) |
|
|
(672 |
) |
Depreciation, amortization, and impairment |
|
(21 |
) |
|
|
(37 |
) |
|
|
(91 |
) |
|
|
(173 |
) |
Adjusted research and
development expense |
$ |
2,688 |
|
|
$ |
3,975 |
|
|
$ |
12,557 |
|
|
$ |
16,636 |
|
Selling, general and administrative expenses |
$ |
9,550 |
|
|
$ |
11,812 |
|
|
$ |
31,750 |
|
|
$ |
52,879 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
|
(708 |
) |
|
|
(402 |
) |
|
|
(2,042 |
) |
|
|
(3,506 |
) |
Depreciation, amortization, and impairment |
|
(17 |
) |
|
|
(43 |
) |
|
|
(79 |
) |
|
|
(324 |
) |
Adjusted selling, general and
administrative expenses |
$ |
8,825 |
|
|
$ |
11,367 |
|
|
$ |
29,629 |
|
|
$ |
49,049 |
|
Aquestive Therapeutics (NASDAQ:AQST)
Historical Stock Chart
From Nov 2024 to Dec 2024
Aquestive Therapeutics (NASDAQ:AQST)
Historical Stock Chart
From Dec 2023 to Dec 2024