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 fourth quarter
and full year ended December 31, 2020 and provided an update
on recent developments in its business.
“2020 was an important year for Aquestive and we
are pleased with the progress we made during the year. We made
exciting progress relating to our epinephrine program and most
recently we now have a clear path to resubmission of our NDA for
Libervant. Additionally, we licensed additional products based on
our differentiated PharmFilm® technology. We more than
doubled the size of Sympazan and the prescriber base that will be
so important to Libervant once approved and launched,” said Keith
Kendall, President and Chief Executive Officer of
Aquestive.
“We are focused on value creation in 2021 by
resubmitting Libervant and, if approved, launching later in the
year. Additionally, we will be very focused on advancing our
epinephrine program through additional studies and ultimately
discussing the program with the FDA,” continued Mr. Kendall.
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. We are developing Libervant as an alternative to the
device driven, invasive, inconvenient, and difficult to administer
alternatives including a rectal gel, currently available for
patients with refractory epilepsy. As a result of the issues many
patients have regarding the current products in the market, a large
portion of the patient population does not receive adequate
treatment or foregoes treatment altogether. The Company believes
that Libervant, if approved by the FDA for US market access, will
enable a larger share of these patients to receive more appropriate
treatment by providing consistent therapeutic dosing in a
non-invasive and innovative treatment form. At a Type A meeting
with the FDA held on November 12, 2020, the FDA confirmed that the
issues identified in the Complete Response Letter (CRL) received by
the Company related to the NDA for Libervant may be addressed by
utilizing modeling and simulations based upon the information
provided by Aquestive in its FDA meeting package submitted in
October 2020. Following the Type A meeting, the Company resubmitted
a revised weight-based dosing regimen along with modeling and
simulations in December 2020. As recently announced, the FDA
provided feedback on the December submission which provided clarity
regarding the information that the Agency expected to see in the
Company’s population pharmacokinetic model and safety data as it
relates specifically to the patient population included in the
studies. The Company will be working on the NDA to provide a
resubmission in a form that the Company believes will be acceptable
to the FDA. Based upon the FDA’s feedback at the Type A meeting and
further guidance from the Agency, the Company continues to believe
that no further clinical studies are necessary and that the Company
will be able to address the identified issues with additional
analytical data that already exists. The Company expects to
resubmit its NDA at the end of the second quarter of 2021. Once the
NDA is resubmitted, the Company anticipates a six month review
process.
EpinephrineAquestive has
scheduled a virtual investor event on March 25, 2021 at 9 am ET to
review the Company’s epinephrine program. At this event, the
Company plans to review the data from the two completed Phase 1 PK
trials, the breadth of its epinephrine pipeline, and the design of
its upcoming Phase 1 PK trial. Utilizing Aquestive’s PharmFilm®
technologies, AQST-108-Sublingual Film (SF) is a “first of its
kind” oral sublingual film formulation delivering systemic
epinephrine that is in development for the treatment of
anaphylaxis. The Company received Fast Track Designation from the
FDA for AQST-108-SF, and recently submitted a dossier to Health
Canada for a third Phase 1 PK trial. The Company plans on
commencing the study, to move towards final formulation and dose,
as soon we receive the necessary documentation.
Sympazan®Despite the continued
limitations on provider in-person interactions caused by the
COVID-19 pandemic, the Company’s proprietary product Sympazan®
(clobazam), an oral film for the treatment of seizures associated
with Lennox-Gastaut syndrome, continues to meet key performance
metrics. Shipment volume has grown 6% sequentially quarter over
quarter and by 59% over the same period last year.
Sympazan net revenue grew 132% for the three-month period ended
December 31, 2020 versus the same period last year, and 97% for the
twelve month period ended December 31, 2020 versus the same period
last year.
Mitsubishi Tanabe Pharma America
Exservan (riluzole) LicenseAquestive entered into a
licensing and supply agreement with Mitsubishi Tanabe Pharma
America, Inc. (MTPA) for the U.S. rights to commercialize EXSERVAN™
(riluzole), an oral film formulation of riluzole for the treatment
of amyotrophic lateral sclerosis (ALS). Pursuant to the
agreement, MTPA will commercialize EXSERVAN in the U.S. Aquestive
will serve as the exclusive sole manufacturer and supplier for the
product. MTPA plans to make EXSERVAN available to
patients in the middle of 2021. The Company now has
licensed Exservan in both the U.S. and Europe.
Additions to Management Team and Board
of DirectorsAquestive has strengthened its management team
and Board of Directors. Ernie Toth was appointed interim Chief
Financial Officer in December 2020. Mr. Toth is a seasoned
financial executive with over two decades of senior financial
leadership at ArisGlobal, Synowledge, and JHP Pharmaceuticals, and
most recently with EHE Health. Mark Lepore, M.D., was appointed as
the Chief Medical Officer for Allergy in January 2021. Dr. Lepore
is a board-certified allergist and pediatrician and has over
fourteen years of drug development experience with prior roles at
Lupin Pharmaceuticals and Teva Pharmaceuticals. Julie Krop, M.D.,
Chief Medical Officer of Freeline Therapeutics, and Marco
Taglietti, M.D., Director, President and Chief Executive Officer of
SCYNEXIS, were appointed as independent directors to the Board in
February 2021.
Fourth Quarter 2020
FinancialsTotal revenues were $7.1 million in the fourth
quarter 2020, compared to $16.4 million in the fourth quarter 2019.
This year-over-year decrease reflected lower Suboxone manufacture
and supply revenue, as well as lower license and royalty revenue,
offset partially by growth in Sympazan revenue.
Aquestive’s net loss for the fourth quarter 2020
was $20.4 million, or $0.60 loss per share. The net loss for the
fourth quarter 2019 was $12.6 million, or $0.48 loss per share. The
change in net loss was driven by lower revenue and offset by
reductions in costs and expenses, primarily in manufacture and
supply expense reflecting the lower volume of production in the
fourth quarter 2020, compared to the fourth quarter 2019.
Adjusted EBITDA loss was $13.0 million in the
fourth quarter 2020, compared to $7.3 million of losses in the
comparable prior period. The year-over-year change in adjusted
EBITDA loss was driven primarily by lower revenue partially offset
by reductions in costs and expenses, primarily in manufacture and
supply expenses, in the fourth quarter 2020, compared to the fourth
quarter 2019.
Full Year 2020 Financials
Total revenues were $45.8 million for the full
year 2020, compared to $52.6 million for the full year 2019. This
year-over-year change came primarily from lower Suboxone
manufacture and supply revenue and co-development and research fees
offset in part by higher license and royalty revenue and
proprietary product revenue, net.
The Company’s net loss for the full year 2020
was $55.8 million, or $1.66 loss per share. The net loss for the
full year 2019 was $66.2 million, or $2.61 loss per share.
Adjusted EBITDA losses were $32.9 million in the
full year 2020, compared to $42.7 million in the full year 2019.
The change in adjusted EBITDA loss was driven by lower revenues and
a reduction in manufacture and supply costs attributable to lower
volumes of Suboxone production in 2020, higher investments in the
commercial launch of Sympazan and increased intellectual property
expenses in 2019 related to the launches of multiple generic
products in competition with Suboxone, partially offset by the
timing of research and development expenses.
As of December 31, 2020, cash and cash
equivalents were $31.8 million. During the fourth quarter 2020,
the Company accessed capital net proceeds of $6.1 million under its
"At-the-Market" (ATM) facility.
2021 Outlook
Aquestive is providing its full year 2021 financial outlook.
The Company expects:
- Total revenues of approximately $38
million to $42 million
- Non-GAAP adjusted gross margins of
approximately 70% to 75% on total revenues
- Non-GAAP adjusted EBITDA loss of
approximately $42 million to $45 million
Aquestive anticipates that the net cash provided
by the KYNMOBI® monetization, the cash position, ATM activity to
date, and expense management efforts will provide the Company with
12 months or more of capital, with additional options for capital,
when needed. As previously stated, those options
include up to $30 million of additional capital available, subject
to FDA approval of Libervant and U.S. market access, under its
existing senior debt facility.
Tomorrow’s Conference Call and Webcast
Reminder The Company will host a conference call at 8:00
a.m. ET on Wednesday, March 10, 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: 7828506.
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 Information
This 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. We 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
outlook for non-GAAP adjusted EBITDA loss 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 loss and
non-GAAP gross margin, a description of the 2019 and 2020
adjustments which have been applicable in determining non-GAAP
Adjusted EBITDA loss and non-GAAP gross margin for these periods
are reflected in the tables below. In providing outlook for
non-GAAP gross margin, we adjust for non-cash share-based
compensation expense and depreciation and amortization. We are
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 advancement and related timing of
Libervant and AQST-108-SF through the regulatory and development
pipeline; the focus on growing the Company’s commercial sales of
Sympazan® and continuing to manufacture Suboxone® and other
licensed products; ability to address the concerns identified in
the FDA’s Complete Response Letter dated September 25, 2020
regarding the New Drug Application for Libervant and obtain FDA
approval of Libervant for U.S. market access; clinical trial timing
and plans for AQST-108-SF; 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-SF and our other drug candidates; risk of delays in
regulatory advancement through the FDA of Libervant and AQST-108-SF
and our other drug candidates or failure to receive approval; risk
of our ability to demonstrate to the FDA “clinical superiority”
within the meaning of the FDA regulations of our drug candidate
Libervant relative to FDA-approved diazepam rectal gel and nasal
spray products including by establishing a major contribution to
patient care within the meaning of FDA regulations relative to the
approved products as well as risks related to other potential
pathways or positions which are or may in the future be advanced to
the FDA to overcome the seven year orphan drug exclusivity granted
by the FDA for the approved nasal spray product of a competitor in
the U.S. and there can be no assurance that we will be successful;
risk that a competitor obtains FDA orphan drug exclusivity for a
product with the same active moiety as any of our other drug
products for which we are seeking FDA approval and that such
earlier approved competitor orphan drug blocks such other product
candidates in the U.S. for seven years for the same indication;
risk that a competitor will obtain other market exclusivity with
respect to our products; risk inherent in commercializing a new
product (including technology risks, financial risks, market risks
and implementation risks and regulatory limitations); risks and
uncertainties concerning the royalty and other revenue stream of
the 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 development of our sales and
marketing capabilities; risk of legal costs associated with and the
outcome of our patent litigation challenging third party at risk
generic sale of our proprietary products; risk of sufficient
capital and cash resources, including access to available debt and
equity financing and revenues from operations, to satisfy all of
our short-term and longer term cash requirements and other cash
needs, at the times and in the amounts needed; risk of failure to
satisfy all financial and other debt covenants and of any default;
our and our competitors’ orphan drug approval and resulting drug
exclusivity for our products or products of our competitors;
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 associated with Indivior’s cessation of production
of its authorized generic buprenorphine naloxone film product,
including the impact from loss of orders for the authorized generic
product and risk of eroding market share for Suboxone and risk of
sunsetting product; risks related to the outsourcing of certain
marketing and other operational and staff functions to third
parties; risk of the rate and degree of market acceptance of our
product and product candidates; the success of any competing
products, including generics; risk of the size and growth of our
product markets; risks of compliance with all FDA and other
governmental and customer requirements for our manufacturing
facilities; risks associated with intellectual property rights and
infringement claims relating to the Company's products; risk of
unexpected patent developments; the impact of existing and future
legislation and regulatory provisions on product exclusivity;
legislation or regulatory actions affecting pharmaceutical product
pricing, reimbursement or access; claims and risks that may arise
regarding the safety or efficacy of the Company's products and
product candidates; risk of loss of significant customers; risks
related to legal proceedings, including patent infringement,
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 (SEC). Given those
uncertainties, you should not place undue reliance on these
forward-looking statements, which speak only as of the date made.
All subsequent forward-looking statements attributable to us or any
person acting on our behalf are expressly qualified in their
entirety by this cautionary statement. The Company assumes no
obligation to update forward-looking statements or outlook or
guidance after the date of this press release whether as a result
of new information, future events or otherwise, except as may be
required by applicable law.
PharmFilm®, Sympazan® and the Aquestive logo are
registered trademarks of Aquestive Therapeutics, Inc. All other
registered trademarks referenced herein are the property of their
respective owners.
Investor inquiries:
Westwicke, an ICR CompanyStephanie
Carringtonstephanie.carington@westwicke.com646-277-1282
AQUESTIVE THERAPEUTICS,
INC.Consolidated Balance
Sheets(In thousands, except share and per share
amounts)(Unaudited)
|
December 31, |
|
2020 |
|
2019 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
31,807 |
|
|
|
$ |
49,326 |
|
|
Trade and other receivables, net |
6,955 |
|
|
|
13,130 |
|
|
Inventories, net |
2,461 |
|
|
|
2,859 |
|
|
Prepaid expenses and other current assets |
3,402 |
|
|
|
2,999 |
|
|
Total current assets |
44,625 |
|
|
|
68,314 |
|
|
Property and equipment,
net |
6,873 |
|
|
|
9,726 |
|
|
Right-of-use assets, net |
3,448 |
|
|
|
— |
|
|
Intangible assets, net |
102 |
|
|
|
153 |
|
|
Other non-current assets |
7,836 |
|
|
|
286 |
|
|
Total assets |
$ |
62,884 |
|
|
|
$ |
78,479 |
|
|
|
|
|
|
Liabilities and
stockholders’ deficit |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
7,089 |
|
|
|
$ |
12,274 |
|
|
Accrued expenses |
8,569 |
|
|
|
5,475 |
|
|
Lease liabilities, current |
728 |
|
|
|
— |
|
|
Deferred revenue |
693 |
|
|
|
806 |
|
|
Liability related to the sale of future revenue, current |
1,450 |
|
|
|
— |
|
|
Loans payable, current |
2,575 |
|
|
|
— |
|
|
Total current liabilities |
21,104 |
|
|
|
18,555 |
|
|
Loans payable, net |
34,329 |
|
|
|
60,338 |
|
|
Liability related to the sale of future revenue, net |
47,524 |
|
|
|
— |
|
|
Lease liabilities |
2,846 |
|
|
|
— |
|
|
Deferred revenue, net of current portion |
3,633 |
|
|
|
4,348 |
|
|
Other non-current liabilities |
1,945 |
|
|
|
1,360 |
|
|
Total liabilities |
111,381 |
|
|
|
84,601 |
|
|
Contingencies (note 20) |
|
|
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
Common stock, $0.001 par value. Authorized 250,000,000 shares;
34,569,254 and 33,562,885 shares issued and outstanding at December
31 2020 and 2019, respectively |
35 |
|
|
|
34 |
|
|
Additional paid-in capital |
137,725 |
|
|
|
124,318 |
|
|
Accumulated deficit |
(186,257 |
) |
|
|
(130,474 |
) |
|
Total stockholders’ deficit |
(48,497 |
) |
|
|
(6,122 |
) |
|
Total liabilities and stockholders’ deficit |
$ |
62,884 |
|
|
|
$ |
78,479 |
|
|
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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues |
$ |
7,149 |
|
|
|
$ |
16,419 |
|
|
|
$ |
45,849 |
|
|
|
$ |
52,609 |
|
|
Costs and expenses: |
|
|
|
|
|
|
|
Manufacture and supply |
2,788 |
|
|
|
6,792 |
|
|
|
12,964 |
|
|
|
20,361 |
|
|
Research and development |
4,425 |
|
|
|
3,057 |
|
|
|
19,886 |
|
|
|
20,574 |
|
|
Selling, general and administrative |
15,582 |
|
|
|
16,474 |
|
|
|
55,892 |
|
|
|
64,342 |
|
|
Total costs and expenses |
22,795 |
|
|
|
26,323 |
|
|
|
88,742 |
|
|
|
105,277 |
|
|
Loss from operations |
(15,646 |
) |
|
|
(9,904 |
) |
|
|
(42,893 |
) |
|
|
(52,668 |
) |
|
Other income (expenses): |
|
|
|
|
|
|
|
Interest expense |
(2,768 |
) |
|
|
(2,803 |
) |
|
|
(11,064 |
) |
|
|
(9,318 |
) |
|
Interest expense related to the sale of future revenue |
(1,958 |
) |
|
|
— |
|
|
|
(1,958 |
) |
|
|
— |
|
|
Interest income and other income (expense), net |
4 |
|
|
|
71 |
|
|
|
132 |
|
|
|
636 |
|
|
Loss on the extinguishment of debt |
— |
|
|
|
— |
|
|
|
— |
|
|
|
(4,896 |
) |
|
Net loss before income taxes |
(20,368 |
) |
|
|
(12,636 |
) |
|
|
(55,783 |
) |
|
|
(66,246 |
) |
|
Income taxes |
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Net loss |
$ |
(20,368 |
) |
|
|
$ |
(12,636 |
) |
|
|
$ |
(55,783 |
) |
|
|
$ |
(66,246 |
) |
|
Comprehensive loss |
$ |
(20,368 |
) |
|
|
$ |
(12,636 |
) |
|
|
$ |
(55,783 |
) |
|
|
$ |
(66,246 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.60 |
) |
|
|
$ |
(0.48 |
) |
|
|
$ |
(1.66 |
) |
|
|
$ |
(2.61 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average number of
common shares outstanding - basic and diluted |
33,821,508 |
|
|
|
26,435,840 |
|
|
|
33,651,127 |
|
|
|
25,356,098 |
|
|
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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Net loss |
$ |
(20,368 |
) |
|
|
$ |
(12,636 |
) |
|
|
$ |
(55,783 |
) |
|
|
$ |
(66,246 |
) |
|
Share-based compensation expense |
1,529 |
|
|
|
1,873 |
|
|
|
6,581 |
|
|
|
7,071 |
|
|
Interest expense |
2,768 |
|
|
|
2,803 |
|
|
|
11,064 |
|
|
|
9,318 |
|
|
Interest expense related to the sale of future revenue |
1,958 |
|
|
|
— |
|
|
|
1,958 |
|
|
|
— |
|
|
Interest income and other income (expense), net |
(4 |
) |
|
|
(71 |
) |
|
|
(132 |
) |
|
|
(636 |
) |
|
Income taxes |
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Depreciation and amortization |
1,157 |
|
|
|
723 |
|
|
|
3,443 |
|
|
|
2,905 |
|
|
Loss on extinguishment of debt |
— |
|
|
|
— |
|
|
|
— |
|
|
|
4,896 |
|
|
Total non-GAAP
adjustments |
$ |
7,408 |
|
|
|
$ |
5,328 |
|
|
|
$ |
22,914 |
|
|
|
$ |
23,554 |
|
|
Adjusted EBITDA |
$ |
(12,960 |
) |
|
|
$ |
(7,308 |
) |
|
|
$ |
(32,869 |
) |
|
|
$ |
(42,692 |
) |
|
AQUESTIVE THERAPEUTICS,
INC.Reconciliation of Non-GAAP Adjustments - Total
Costs and Expenses to Adjusted Costs and
Expenses(In
Thousands)(Unaudited)
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Total costs and expenses |
$ |
22,795 |
|
|
|
$ |
26,323 |
|
|
|
$ |
88,742 |
|
|
|
$ |
105,277 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
(1,529 |
) |
|
|
(1,873 |
) |
|
|
(6,581 |
) |
|
|
(7,071 |
) |
|
Depreciation and amortization |
(1,157 |
) |
|
|
(723 |
) |
|
|
(3,443 |
) |
|
|
(2,905 |
) |
|
Adjusted costs and
expenses |
$ |
20,109 |
|
|
|
$ |
23,727 |
|
|
|
$ |
78,718 |
|
|
|
$ |
95,301 |
|
|
AQUESTIVE THERAPEUTICS,
INC.Reconciliation of Non-GAAP Adjustments -
Manufacture & Supply Expense to Adjusted Manufacture and Supply
Expense(In Thousands, except
percentages)(Unaudited)
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Manufacture and supply expense |
$ |
2,788 |
|
|
|
$ |
6,792 |
|
|
|
$ |
12,964 |
|
|
|
$ |
20,361 |
|
|
Gross Margin on total revenue |
61 |
|
% |
|
59 |
|
% |
|
72 |
|
% |
|
61 |
|
% |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
(67 |
) |
|
|
(50 |
) |
|
|
(275 |
) |
|
|
(231 |
) |
|
Depreciation and amortization |
(503 |
) |
|
|
(585 |
) |
|
|
(2,374 |
) |
|
|
(2,350 |
) |
|
Adjusted manufacture and
supply expense |
$ |
2,218 |
|
|
|
$ |
6,157 |
|
|
|
$ |
10,315 |
|
|
|
$ |
17,780 |
|
|
Non-GAAP Gross Margin on total revenue |
69 |
|
% |
|
63 |
|
% |
|
78 |
|
% |
|
66 |
|
% |
AQUESTIVE THERAPEUTICS,
INC.Reconciliation of Non-GAAP Adjustments -
Research and Development Expense to Adjusted Research and
Development Expense(In
Thousands)(Unaudited)
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Research and development expense |
$ |
4,425 |
|
|
|
$ |
3,057 |
|
|
|
$ |
19,886 |
|
|
|
$ |
20,574 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
(186 |
) |
|
|
(185 |
) |
|
|
(729 |
) |
|
|
(720 |
) |
|
Depreciation and amortization |
(46 |
) |
|
|
(65 |
) |
|
|
(225 |
) |
|
|
(265 |
) |
|
Adjusted research and
development expense |
$ |
4,193 |
|
|
|
$ |
2,807 |
|
|
|
$ |
18,932 |
|
|
|
$ |
19,589 |
|
|
AQUESTIVE THERAPEUTICS,
INC.Reconciliation of Non-GAAP Adjustments -
Selling, General and Administrative Expenses to Adjusted Selling,
General andAdministrative
Expenses(In
Thousands)(Unaudited)
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Selling, general and administrative expenses |
$ |
15,582 |
|
|
|
$ |
16,474 |
|
|
|
$ |
55,892 |
|
|
|
$ |
64,342 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense |
(1,276 |
) |
|
|
(1,632 |
) |
|
|
(5,577 |
) |
|
|
(6,120 |
) |
|
Depreciation and amortization |
(607 |
) |
|
|
(73 |
) |
|
|
(843 |
) |
|
|
(290 |
) |
|
Adjusted selling, general and
administrative expenses |
$ |
13,699 |
|
|
|
$ |
14,769 |
|
|
|
$ |
49,472 |
|
|
|
$ |
57,932 |
|
|
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