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 reported financial results for the third quarter
ended September 30, 2021 and provided an update on recent
developments in its business.
“We continue to interact with the FDA regarding
the NDA submission for Libervant, including responding to several
information requests to date, having a recent inspection of our
post-marketing adverse event capabilities, regarding changes in
language relating to our packaging, approval of the product trade
name and an update to the patent information included in the
resubmission. We are continuing to prepare for commercialization
with payer and sales force planning underway,” said Keith Kendall,
Chief Executive Officer of Aquestive. “We recently demonstrated
clinical results comparable to the autoinjectors in the recently
completed Phase 1 trial for AQST-109, potentially the first orally
administered epinephrine product for the emergency treatment of
allergic reactions, including anaphylaxis. Before year end, we
anticipate receiving written feedback from the FDA following our
pre-IND meeting request and plan to commence an adaptive design
crossover study that will determine the final formulation and dose
strength leading to our pivotal PK study in 2022.”
Libervant™Libervant™ is a
buccally, or inside of the cheek, administered soluble film
formulation of diazepam, a benzodiazepine intended for rapid
treatment of acute uncontrolled seizures in selected, refractory
patients with epilepsy on stable regimens of AEDs who require
intermittent use of diazepam to control bouts of increased seizure
activity. The Company believes that Libervant, if approved by the
U.S. Food and Drug Administration (FDA) for U.S. market access,
will enable a larger share of patients to receive more appropriate
treatment by providing consistent therapeutic dosing in a
non-invasive and innovative treatment form for epileptic seizures.
Aquestive is developing Libervant as an alternative to more
invasive, inconvenient, and difficult to administer device driven
products, including a rectal gel and nasal spray, for patients with
refractory epilepsy. A large portion of the patient population
still does not access either one of these existing products and
remains underserved with regard to having an important medication
where they need it, when they need it and in a form they
prefer.
Aquestive continues to actively engage with the
FDA regarding its accepted New Drug Application (NDA) for Libervant
ahead of the Prescription Drug User Fee Act (PDUFA) target goal
date of December 23, 2021. Aquestive has again spoken with and
provided additional information to the FDA Office of Orphan
Products Development (OOPD) that the Company believes provides a
clear position of clinical superiority as a major contribution to
patient care as compared to the device driven rectal gel and nasal
spray alternatives.
EpinephrineAquestive continues
to advance its development of product candidate AQST-109
(epinephrine prodrug sublingual film) for the emergency treatment
of severe allergic reactions, including anaphylaxis, utilizing
Aquestive’s PharmFilm® technologies. The Company reported positive
topline data from its first-in-human Phase 1 pharmacokinetic (PK)
trial for AQST-109. Findings from this study support AQST-109's
potential as the first orally administered and transformative
epinephrine-based product for the treatment of allergic reactions
including anaphylaxis with safety, tolerability, PK and
pharmacodynamics (PD) measures comparable to those of the standard
of care autoinjectors, such as EpiPen® and Auvi-Q®. These products
require patients or caregivers to inject epinephrine into their
thighs during an emergency allergic reaction. However, AQST-109
would, if approved by the FDA, allow a patient to simply place a
dissolvable strip, approximately the size and weight of a postage
stamp, under the tongue, again providing an appropriate medication
where it is needed, when it is needed and in a form preferred by
patients.
Aquestive has submitted its request for a
pre-Investigational New Drug (IND) meeting with the FDA and
anticipates receiving a written response from the FDA before year
end 2021. Aquestive is on track to conduct a crossover study using
an adaptive design for AQST-109 beginning in the fourth quarter
2021. This study will determine the final formulation and dose for
AQST-109 and allow the Company to move forward to the manufacture
of registration batches and a pivotal PK study in 2022.
Sympazan®The
Company’s proprietary product Sympazan® (clobazam), an oral film
for the treatment of seizures associated with Lennox-Gastaut
syndrome, continued to grow in shipment volumes to the prescriber
base for the third quarter 2021. Sympazan has grown quarterly over
the past eleven sequential quarters since its launch.
Third Quarter 2021
FinancialsTotal revenues were $13.3 million in the third
quarter 2021, compared to $8.3 million in the third quarter 2020.
For the third quarter 2021 compared to the prior year period, the
Company saw an 18% increase in Sympazan net revenue and a 77%
increase in manufacture and supply revenue.
Aquestive’s net loss for the third quarter 2021
was $14.6 million, or $0.37 loss per share. The net loss for the
third quarter 2020 was $16.6 million, or $0.49 loss per share. The
year-over-year change in net loss was driven by higher revenue,
lower costs and expenses, offset by an increase in non-cash
interest expense related to the KYNMOBI® monetization transaction,
which does not represent a cash output or monetary obligation at
any time during the life of the transaction.
Adjusted EBITDA loss was $5.3 million in the
third quarter 2021, compared to a loss of $11.3 million in the
third quarter of 2020. The year-over-year change in adjusted EBITDA
was primarily driven by higher revenue and an increase in non-cash
interest expense related to the KYNMOBI® monetization transaction,
which does not represent a cash output or monetary obligation at
any time during the life of the transaction.
As of September 30, 2021, cash and cash
equivalents were $31.2 million. During the third quarter 2021,
Aquestive accessed capital under its "At-The-Market" (ATM) facility
resulting in net proceeds of $6.1 million.
On September 30, 2021, the Company entered into
a waiver agreement with the holders of the 12.5% Notes (the
"Notes") pursuant to which the principal payment due under the
Notes on September 30, 2021 was deferred in order to provide
sufficient time for the execution of the Fourth Supplemental
Indenture of the existing debt facility. The Fourth Supplemental
Indenture was subsequently executed in October 2021 which extended
the date of the first amortization payment to March 30, 2023,
resulting in a deferral of $10.3M in principal payments through
December 2022. The Fourth Supplemental Indenture did not change the
maturity date of the Notes or the interest payment obligation due
under the Notes. As part of the agreement, the Company entered into
a Consent Fee Letter pursuant to which the Company agreed to pay
the holders of the Notes a $2.7 million fee, payable in four
quarterly installments beginning May 15, 2022.
2021 OutlookSympazan and the
Company's other on-going business activities generated strong
operating results during the first half of 2021. As a result, the
Company has revised its full year expectations as follows:
|
Updated Guidance |
|
Prior Guidance |
Total revenue (in
millions) |
$47 to $49 |
|
$46 to $48 |
Non-GAAP adjusted gross
margins |
70% to 75% |
|
70% to 75% |
Non-GAAP adjusted EBITDA loss
(in millions) |
$32 to $34 |
|
$39 to $42 |
Tomorrow’s Conference Call and Webcast
ReminderThe Company will host a conference call at 8:00
a.m. ET on Wednesday, November 3, 2021. Investors and analysts may
participate in the conference call by dialing (866) 417-5886 from
the U.S. and (409) 217-8235 internationally, followed by the
conference ID: 4285256.
There will also be a simultaneous, live webcast
available on the Investors section of the Company’s website at
https://investors.aquestive.com/events-and-presentations. The
webcast will be archived for 30 days.
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.
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 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 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 2021 and 2020
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 are
“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 clinical advancement and related timing of
Libervant and AQST-109 through the regulatory and development
pipeline; the potential for AQST-109 as the first orally
administered epinephrine prodrug for the treatment of anaphylaxis;
the focus on growing the Company’s commercial sales of Sympazan®;
the ability to address the concerns identified in the FDA’s
Complete Response Letter dated September 25, 2020 regarding the NDA
for Libervant; obtaining FDA approval of Libervant for U.S. market
access; the timing of the PDUFA target goal date; the 2021
financial outlook; and business strategies, market opportunities,
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 our business including with respect
to our clinical trials including site initiation, patient
enrollment and timing and adequacy of clinical trials; on
regulatory submissions and regulatory reviews and approvals of our
product candidates; pharmaceutical ingredient and other raw
materials supply chain, manufacture, and distribution; sale of and
demand for our products; our liquidity and availability of capital
resources; customer demand for our products and services;
customers’ ability to pay for goods and services; and ongoing
availability of an appropriate labor force and skilled
professionals. Given these uncertainties, the Company is unable to
provide assurance that operations can be maintained as planned
prior to the COVID-19 pandemic.
These forward-looking statements are also based
on our current expectations and beliefs and are subject to a number
of risks and uncertainties that could cause actual results to
differ materially from those described in the forward-looking
statements. Such risks and uncertainties include, but are not
limited to, risks associated with the Company's development work,
including any delays or changes to the timing, cost and success of
our product development activities and clinical trials and plans
for AQST-108, AQST-109 and our other drug candidates; risk of
delays in regulatory advancement through the FDA of Libervant,
AQST-108, AQST-109 and our other drug candidates or failure to
receive approval, including the risk that the FDA may require
additional clinical studies for FDA approval of Libervant for U.S.
market access; risk of our ability to demonstrate to the FDA the
“clinical superiority” of Libervant within the meaning of the FDA
regulations 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 the Company 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 product candidates 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 that a competitor will obtain other market
exclusivity with respect to our product candidates; risk in
obtaining market access for our product candidates for other
reasons; risk inherent in commercializing a new product (including
technology risks, financial risks, market risks and implementation
risks and regulatory limitations); 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; risks and
uncertainties concerning the royalty and other revenue stream of
the KYNMOBI® monetization, achievement of royalty targets worldwide
or in any jurisdiction and certain other commercial targets
required for contingent payments under the monetization
transaction; risk of failure to satisfy all financial and other
debt covenants and of any default; short-term and long-term
liquidity and cash requirements, cash funding and cash burn; 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 of eroding
market share for Suboxone and risk of a 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;
including anticipated sales of Sympazan®; risk of loss of
significant customers; risks related to legal proceedings,
including patent infringement, securities, investigative and
antitrust litigation matters; changes in government laws and
regulations; risk of product recalls and withdrawals; uncertainties
related to general economic, political, business, industry,
regulatory and market conditions and other unusual items; and other
uncertainties affecting the Company described in the “Risk Factors”
section and in other sections included in our Annual Report on Form
10-K, in our Quarterly Reports on Form 10-Q, and in our Current
Reports on Form 8-K filed with the Securities Exchange Commission.
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:ICR WestwickeStephanie
Carringtonstephanie.carrington@westwicke.com646-277-1282
AQUESTIVE THERAPEUTICS,
INC.Condensed Consolidated Balance
Sheets(In thousands, except share and per share
amounts)(Unaudited)
|
September 30,2021 |
|
December 31,2020 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
31,164 |
|
|
|
$ |
31,807 |
|
|
Trade and other receivables, net |
13,643 |
|
|
|
6,955 |
|
|
Inventories, net |
2,863 |
|
|
|
2,461 |
|
|
Prepaid expenses and other current assets |
2,540 |
|
|
|
3,402 |
|
|
Total current assets |
50,210 |
|
|
|
44,625 |
|
|
Property and equipment, net |
5,197 |
|
|
|
6,873 |
|
|
Right-of-use assets, net |
2,917 |
|
|
|
3,448 |
|
|
Intangible assets, net |
64 |
|
|
|
102 |
|
|
Other non-current assets |
6,905 |
|
|
|
7,836 |
|
|
Total assets |
$ |
65,293 |
|
|
|
$ |
62,884 |
|
|
|
|
|
|
Liabilities and
stockholders’ deficit |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
6,215 |
|
|
|
$ |
7,089 |
|
|
Accrued expenses |
7,624 |
|
|
|
8,569 |
|
|
Lease liabilities, current |
860 |
|
|
|
728 |
|
|
Deferred revenue, current |
767 |
|
|
|
693 |
|
|
Liability related to the sale of future revenue, current |
1,848 |
|
|
|
1,450 |
|
|
Loans payable, current |
7,725 |
|
|
|
2,575 |
|
|
Total current liabilities |
25,039 |
|
|
|
21,104 |
|
|
Loans payable, net |
32,673 |
|
|
|
34,329 |
|
|
Liability related to the sale of future revenue, net |
56,615 |
|
|
|
47,524 |
|
|
Lease liabilities |
2,185 |
|
|
|
2,846 |
|
|
Deferred revenue |
7,316 |
|
|
|
3,633 |
|
|
Other non-current liabilities |
1,810 |
|
|
|
1,945 |
|
|
Total liabilities |
125,638 |
|
|
|
111,381 |
|
|
Contingencies (Note
19) |
|
|
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
Common stock, $0.001 par value. Authorized 250,000,000 shares;
40,083,245 and 34,569,254 shares issued and outstanding at
September 30, 2021 and December 31, 2020, respectively |
40 |
|
|
|
35 |
|
|
Additional paid-in capital |
167,466 |
|
|
|
137,725 |
|
|
Accumulated deficit |
(227,851 |
) |
|
|
(186,257 |
) |
|
Total stockholders’ deficit |
(60,345 |
) |
|
|
(48,497 |
) |
|
Total liabilities and stockholders’ deficit |
$ |
65,293 |
|
|
|
$ |
62,884 |
|
|
AQUESTIVE THERAPEUTICS,
INC.Condensed Consolidated Statements of
Operations and Comprehensive Loss(In thousands,
except share and per share data
amounts)(Unaudited)
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues |
$ |
13,287 |
|
|
|
$ |
8,260 |
|
|
|
$ |
39,754 |
|
|
|
$ |
38,700 |
|
|
Costs and expenses: |
|
|
|
|
|
|
|
Manufacture and supply |
4,400 |
|
|
|
2,978 |
|
|
|
11,623 |
|
|
|
10,176 |
|
|
Research and development |
4,726 |
|
|
|
7,260 |
|
|
|
12,647 |
|
|
|
15,461 |
|
|
Selling, general and administrative |
12,129 |
|
|
|
11,803 |
|
|
|
38,494 |
|
|
|
40,310 |
|
|
Total costs and expenses |
21,255 |
|
|
|
22,041 |
|
|
|
62,764 |
|
|
|
65,947 |
|
|
Loss from operations |
(7,968 |
) |
|
|
(13,781 |
) |
|
|
(23,010 |
) |
|
|
(27,247 |
) |
|
Other income/(expenses): |
|
|
|
|
|
|
|
Interest expense |
(2,787 |
) |
|
|
(2,778 |
) |
|
|
(8,305 |
) |
|
|
(8,296 |
) |
|
Interest expense related to the sale of future revenue, net |
(3,767 |
) |
|
|
— |
|
|
|
(10,567 |
) |
|
|
— |
|
|
Interest and other (expense) income, net |
(33 |
) |
|
|
8 |
|
|
|
288 |
|
|
|
128 |
|
|
Net loss before income
taxes |
(14,555 |
) |
|
|
(16,551 |
) |
|
|
(41,594 |
) |
|
|
(35,415 |
) |
|
Income taxes |
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Net loss |
$ |
(14,555 |
) |
|
|
$ |
(16,551 |
) |
|
|
$ |
(41,594 |
) |
|
|
$ |
(35,415 |
) |
|
Comprehensive loss |
$ |
(14,555 |
) |
|
|
$ |
(16,551 |
) |
|
|
$ |
(41,594 |
) |
|
|
$ |
(35,415 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted |
$ |
(0.37 |
) |
|
|
$ |
(0.49 |
) |
|
|
$ |
(1.12 |
) |
|
|
$ |
(1.05 |
) |
|
Weighted-average number of
common shares outstanding - basic and diluted |
39,224,863 |
|
|
|
33,619,379 |
|
|
|
37,297,892 |
|
|
|
33,592,846 |
|
|
AQUESTIVE THERAPEUTICS,
INC.Reconciliation of Non-GAAP Adjustments - Net
Loss to Adjusted EBITDA(In
Thousands)(Unaudited)
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
GAAP net loss |
$ |
(14,555 |
) |
|
|
$ |
(16,551 |
) |
|
|
$ |
(41,594 |
) |
|
|
$ |
(35,415 |
) |
|
Share-based Compensation Expense |
1,900 |
|
|
|
1,765 |
|
|
|
|
5,128 |
|
|
|
|
3,625 |
|
|
Interest expense |
2,787 |
|
|
|
2,778 |
|
|
|
|
8,305 |
|
|
|
|
8,296 |
|
|
Interest expense related to the sale of future revenue, net |
3,767 |
|
|
|
— |
|
|
|
|
10,567 |
|
|
|
|
— |
|
|
Interest and other (income) expense, net |
33 |
|
|
|
(8 |
) |
|
|
|
(288 |
) |
|
|
|
(128 |
) |
|
Income Taxes |
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
Depreciation and Amortization |
736 |
|
|
|
754 |
|
|
|
|
2,233 |
|
|
|
|
2,337 |
|
|
Total non-GAAP
adjustments |
$ |
9,223 |
|
|
|
$ |
5,289 |
|
|
|
$ |
25,945 |
|
|
|
$ |
14,130 |
|
|
Adjusted EBITDA |
$ |
(5,332 |
) |
|
|
$ |
(11,262 |
) |
|
|
$ |
(15,649 |
) |
|
|
$ |
(21,285 |
) |
|
AQUESTIVE THERAPEUTICS,
INC.Reconciliation of Non-GAAP Adjustments - GAAP
Expenses to Adjusted Expenses(In
Thousands)(Unaudited)
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Total costs and expenses |
$ |
21,255 |
|
|
|
$ |
22,041 |
|
|
|
$ |
62,764 |
|
|
|
$ |
65,947 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
(1,900 |
) |
|
|
(1,765 |
) |
|
|
(5,128 |
) |
|
|
(3,625 |
) |
|
Depreciation and amortization |
(736 |
) |
|
|
(754 |
) |
|
|
(2,233 |
) |
|
|
(2,337 |
) |
|
Adjusted costs and
expenses |
$ |
18,619 |
|
|
|
$ |
19,522 |
|
|
|
$ |
55,403 |
|
|
|
$ |
59,985 |
|
|
AQUESTIVE THERAPEUTICS,
INC.Reconciliation of Non-GAAP Adjustments - GAAP
Manufacture & Supply Expense to Adjusted Manufacture and Supply
Expense(In Thousands, except
percentages)(Unaudited)
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Manufacture and Supply Expense |
$ |
4,400 |
|
|
|
$ |
2,978 |
|
|
|
$ |
11,623 |
|
|
|
$ |
10,176 |
|
|
Gross Margin on total revenue |
67 |
% |
|
|
64 |
% |
|
|
71 |
% |
|
|
74 |
% |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
(88 |
) |
|
|
(72 |
) |
|
|
(241 |
) |
|
|
(135 |
) |
|
Depreciation and amortization |
(579 |
) |
|
|
(617 |
) |
|
|
(1,744 |
) |
|
|
(1,163 |
) |
|
Adjusted manufacture and
supply expense |
$ |
3,733 |
|
|
|
$ |
2,289 |
|
|
|
$ |
9,638 |
|
|
|
$ |
8,878 |
|
|
Non-GAAP Gross Margin on total revenue |
72 |
% |
|
|
72 |
% |
|
|
76 |
% |
|
|
77 |
% |
|
AQUESTIVE THERAPEUTICS,
INC.Reconciliation of Non-GAAP Adjustments - GAAP
Research and Development Expense to Adjusted Research and
Development Expense(In
Thousands)(Unaudited)
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Research and Development
Expense |
$ |
4,726 |
|
|
|
$ |
7,260 |
|
|
|
$ |
12,647 |
|
|
|
$ |
15,461 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
(230 |
) |
|
|
(183 |
) |
|
|
(670 |
) |
|
|
(365 |
) |
|
Depreciation and amortization |
(51 |
) |
|
|
(59 |
) |
|
|
(160 |
) |
|
|
(119 |
) |
|
Adjusted research and
development expense |
$ |
4,445 |
|
|
|
$ |
7,018 |
|
|
|
$ |
11,817 |
|
|
|
$ |
14,977 |
|
|
AQUESTIVE THERAPEUTICS,
INC.Reconciliation of Non-GAAP Adjustments - GAAP
Selling, General and Administrative Expenses to Adjusted Selling,
General andAdministrative
Expenses(In
Thousands)(Unaudited)
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Selling, General and Administrative Expenses |
$ |
12,129 |
|
|
|
$ |
11,803 |
|
|
|
$ |
38,494 |
|
|
|
$ |
40,310 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
(1,582 |
) |
|
|
(1,510 |
) |
|
|
(4,217 |
) |
|
|
(3,125 |
) |
|
Depreciation and amortization |
(106 |
) |
|
|
(78 |
) |
|
|
(329 |
) |
|
|
(1,055 |
) |
|
Adjusted selling, general and
administrative expenses |
$ |
10,441 |
|
|
|
$ |
10,215 |
|
|
|
$ |
33,948 |
|
|
|
$ |
36,130 |
|
|
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