Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty
pharmaceutical company focused on developing and commercializing
differentiated products that meet patients’ unmet needs and solve
therapeutic problems, today reported financial results for the
third quarter ended September 30, 2019 and provided an update on
recent developments in its business.
“The third quarter was an important one in our
evolution. We successfully completed the crossover study requested
by the U.S. Food and Drug Administration (FDA) for Libervant
compared to the reference listed rectal gel. We also completed our
proof-of-concept study for epinephrine, AQST-108, for the treatment
of allergic reactions including anaphylaxis, and requested a
pre-IND meeting with the FDA. In addition, we advanced the
commercialization of Sympazan® with more than 50% growth of
shipments to retailers since the end of the second quarter,” said
Keith J. Kendall, Chief Executive Officer of Aquestive.
Proprietary Pipeline Overview and
Business UpdateAquestive is building a portfolio of
differentiated medicines that can offer physicians and patients,
who have difficulty using currently available treatment options,
improved clinical and usability features based on the Company’s
PharmFilm® technology. The Company’s late stage proprietary
products are initially focused on CNS conditions, and other patient
populations with high unmet need.
- Aquestive is expected to complete
its rolling NDA submission for Libervant (diazepam) Buccal Film
around the end of November 2019, after having filed the CMC portion
in September 2019. Libervant has the potential to be the first oral
therapy approved by the FDA for the management of seizure clusters
in the population of 1.2 million refractory epilepsy patients and
the first diazepam based treatment usable by and delivering a
consistent predictable dose to virtually all patients to whom it is
prescribed.
- Positive data reported from Phase 1
dose escalation proof-of-concept study in healthy subjects for
AQST-108, a “first in class” oral sublingual film formulation of
epinephrine, demonstrated the ability to deliver systemic
epinephrine using Aquestive’s proprietary PharmFilm
formulation.
- Adoption of Sympazan® (clobazam)
oral film for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) continues to grow, with shipments to
retailers increasing over 50% as compared to the quarter ended in
June.
Third Quarter 2019 Financial
ResultsTotal revenues were $12.4 million in the third
quarter 2019, compared to $13.3 million in the third quarter 2018.
This year-over-year decrease reflected lower license and royalty
revenue in 2019 as expected, offset by growth from manufacturing
and supply revenue related to Suboxone and the authorized generic
product volume growth, as well as proprietary net revenue from
Sympazan sales.
Aquestive’s net loss for the third quarter 2019
was $18.4 million, or $0.74 loss per share. The net loss for the
third quarter 2018 was $15.0 million, or $0.64 loss per share. The
year-over-year change in net loss was driven primarily by higher
investments in 2019 in the commercialization of Sympazan, and in
the development of Libervant and AQST-108. Cash and cash
equivalents as of September 30, 2019 were $20.9 million.
2019 OutlookAquestive is
raising its full year revenue and earnings guidance and updating
its financial outlook for 2019. The Company expects:
- Total revenues of $45 million to
$47 million;
- Non-GAAP gross margins of 67% to
69% on total revenues;
- Non-GAAP adjusted EBITDA loss of
$49 million to $50 million; and
- Cash burn of approximately $60
million to $65 million after considering interest, capital spending
and working capital effects, but prior to any additional
non-dilutive capital transactions.
Today’s Conference Call and Webcast
ReminderAquestive announced that it will report results
for the third quarter ended September 30, 2019 and provide a
business update on Wednesday, November 6, 2019 before the market
open. The Company will host an investment community conference call
at 8:00 a.m. ET on Wednesday, November 6, 2019. 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: 4779544. 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 specialty
pharmaceutical company that applies innovative technology to solve
therapeutic problems and improve medicines for patients. Aquestive
is advancing a late-stage proprietary product pipeline to treat CNS
conditions and 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 Adjusted EBITDA, non-GAAP gross margins,
non-GAAP costs and expenses, because such measures exclude, as
applicable, share-based compensation, interest expense, interest
income, depreciation, amortization, and income taxes.
Specifically, the Company adjusts net income
(loss) for one-time IPO related expenditures; change in fair value
of warrants; loss on the extinguishment of debt; recurring non-cash
expenditures, including share-based compensation expenses;
depreciation and amortization; and for interest expense, interest
income and income taxes, with a result of Adjusted EBITDA.
Similarly, manufacturing and supply expense, research and
development expense, and selling, general and administrative
expense were adjusted for the recurring non-cash expenditures of
share-based compensation expense and depreciation and amortization.
Adjusted EBITDA 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,
its future manufacturing 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 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 and non-GAAP gross margin, we
exclude certain items which are otherwise included in determining
the comparable GAAP financial measures. A description of the
adjustments which have been applicable in determining Adjusted
EBITDA for the three and nine month periods ended September 30,
2019 and 2018 are reflected in the table 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 StatementThis
press release includes 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 may
include, but are not limited to, statements regarding therapeutic
benefits and plans and objectives for regulatory approval of
Libervant and other product candidates; statements about our growth
and future financial and operating results and financial position,
ability to advance Libervant and our other product candidates to
the market, regulatory approvals and pathways, clinical trial
timing and plans, short-term and long-term liquidity and cash
requirements, cash funding and cash burn, 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 the Company's development work, including any
delays or changes to the timing, cost and success of our product
development activities and clinical trials; risk of delays in FDA
approval of our drug candidates or failure to receive approval;
risk inherent in commercializing a new product (including
technology risks, financial risks, market risks and implementation
risks and regulatory limitations); risk that a competitor obtains
orphan drug exclusivity and blocks our product for the same
indication for seven years; 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;
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; risks
associated with Indivior’s announcement of its intention to cease
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 sales, marketing and other operational and
staff functions to third parties; risk of the rate and degree of
market acceptance of our products and product candidates; 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 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 action 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, investigative and antitrust
litigation matters; changes in governmental 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 risks and
uncertainties affecting the Company including those described in
the "Risk Factors" section and in other sections included in the
Company's Annual Report on Form 10‑K filed with the SEC on March
14, 2019 and in our quarterly reports on Form 10-Q. Given these
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.
SYMPAZAN IMPORTANT SAFETY INFORMATIONBOXED
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDSConcomitant use of
benzodiazepines and opioids may result in profound sedation,
respiratory depression, coma, and death.
- Reserve concomitant prescribing of these drugs for use in
patients for whom alternative treatment options are
inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory
depression and sedation.
CONTRAINDICATIONSSYMPAZAN is contraindicated in patients with a
history of hypersensitivity to the drug or its ingredients.
Hypersensitivity reactions have included serious dermatological
reactions.
WARNINGS AND PRECAUTIONSPotentiation of Sedation from
Concomitant Use with Central Nervous System (CNS)
DepressantsSYMPAZAN has a CNS depressant effect. Caution patients
and/or caregivers against simultaneous use with other CNS
depressants or alcohol as the effects of other CNS depressants or
alcohol may be potentiated.
Somnolence or SedationSYMPAZAN causes dose-related somnolence
and sedation, which generally begins within the first month of
treatment and may diminish with continued treatment. Monitor
patients for somnolence and sedation, particularly with concomitant
use of other CNS depressants. Caution patients against engaging in
hazardous activities requiring mental alertness, i.e., operating
dangerous machinery or motor vehicles, until the effect of SYMPAZAN
is known.
Withdrawal SymptomsAbrupt discontinuation of SYMPAZAN should be
avoided. The risk of withdrawal symptoms is greater with higher
doses. Withdraw SYMPAZAN gradually to minimize the risk of
precipitating seizures, seizure exacerbation, or status
epilepticus.
Serious Dermatological ReactionsSerious skin reactions,
including Stevens-Johnson syndrome (SJS) and toxic epidermal
necrolysis (TEN), have been reported with clobazam in both children
and adults. Discontinue SYMPAZAN at the first sign of rash, unless
the rash is clearly not drug-related.
Physical and Psychological DependencePatients with a history of
substance abuse should be under careful surveillance when receiving
SYMPAZAN.
Suicidal Behavior and IdeationAEDs, including SYMPAZAN, increase
the risk of suicidal thoughts or behavior in patients. Patients
treated with SYMPAZAN should be monitored for the emergence or
worsening of depression, suicidal thoughts or behavior, and/or any
unusual changes in mood or behavior. Inform patients, their
caregivers, and families of the increased risk of suicidal thoughts
and behaviors. Advise them to be alert for and report immediately
to healthcare providers any emergence or worsening signs and
symptoms of depression, any unusual changes in mood or behavior, or
the emergence of suicidal thoughts, behavior, or thoughts of
self-harm.
ADVERSE REACTIONSAdverse reactions (≥10% and more frequently
than placebo) included constipation, somnolence or sedation,
pyrexia, lethargy, and drooling.
DRUG INTERACTIONSThe concomitant use of benzodiazepines and
opioids increases the risk of respiratory depression. Limit dosage
and duration of concomitant use of benzodiazepines and opioids and
follow patients closely for respiratory depression and sedation.
Concomitant use of SYMPAZAN with other CNS depressants, including
alcohol, may increase the risk of sedation and somnolence. Caution
patients and/or caregivers against simultaneous use with other CNS
depressants or alcohol, as effects of other CNS depressants or
alcohol may be potentiated.Hormonal contraceptives that are
metabolized by CYP3A4; effectiveness may be diminished when given
with SYMPAZAN. Additional non-hormonal forms of contraception are
recommended when using SYMPAZAN. Dose adjustment may be necessary
of drugs metabolized by CYP2D6 and of SYMPAZAN when co-administered
with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine,
ticlopidine).
USE IN SPECIFIC POPULATIONSPregnancy and Lactation: SYMPAZAN may
cause fetal harm and should only be used during pregnancy if the
potential benefit justifies the potential risk to the fetus.
Infants born to mothers who have taken benzodiazepines during the
later stages of pregnancy can develop dependence, withdrawal
syndrome and symptoms suggestive of floppy infant syndrome.
SYMPAZAN is excreted in human milk. Because of the potential for
serious adverse reactions in nursing infants from SYMPAZAN,
discontinue nursing or discontinue the drug. Encourage patients to
call the toll-free number 1-888-233-2334 to enroll in the Pregnancy
Registry or visit http://www.aedpregnancyregistry.org/.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Please click here to see full Prescribing Information, including
the Boxed Warning.
AQUESTIVE
THERAPEUTICS, INC. |
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
(In
thousands, except share and per share data amounts) |
(Unaudited) |
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
|
|
|
September
30, |
|
|
September
30, |
|
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
12,418 |
|
|
$ |
13,267 |
|
|
|
$ |
36,190 |
|
|
$ |
50,606 |
|
Costs and Expenses: |
|
|
|
|
|
|
|
|
|
Manufacture and supply |
|
4,643 |
|
|
|
5,592 |
|
|
|
|
13,569 |
|
|
|
16,201 |
|
|
Research and development |
|
5,063 |
|
|
|
4,534 |
|
|
|
|
17,517 |
|
|
|
17,429 |
|
|
Selling, general and administrative |
|
13,714 |
|
|
|
12,346 |
|
|
|
|
47,868 |
|
|
|
53,559 |
|
|
|
|
|
Total costs and expenses |
|
23,420 |
|
|
|
22,472 |
|
|
|
|
78,954 |
|
|
|
87,189 |
|
|
|
|
|
(Loss) from operations |
|
(11,002 |
) |
|
|
(9,205 |
) |
|
|
|
(42,764 |
) |
|
|
(36,583 |
) |
Other income/(expenses): |
|
|
|
|
|
|
|
|
|
Interest expense |
|
(2,652 |
) |
|
|
(1,933 |
) |
|
|
|
(6,515 |
) |
|
|
(5,809 |
) |
|
Interest income |
|
138 |
|
|
|
216 |
|
|
|
|
565 |
|
|
|
238 |
|
|
Loss on extinguishment of debt |
|
(4,896 |
) |
|
|
- |
|
|
|
|
(4,896 |
) |
|
|
- |
|
|
Change in fair value of warrant |
|
- |
|
|
|
(4,116 |
) |
|
|
|
- |
|
|
|
(5,278 |
) |
|
|
Net (loss) before income taxes |
|
(18,412 |
) |
|
|
(15,038 |
) |
|
|
|
(53,610 |
) |
|
|
(47,432 |
) |
|
Income taxes |
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
Net (loss) |
|
(18,412 |
) |
|
|
(15,038 |
) |
|
|
|
(53,610 |
) |
|
|
(47,432 |
) |
|
|
Comprehensive (loss) |
$ |
(18,412 |
) |
|
$ |
(15,038 |
) |
|
|
$ |
(53,610 |
) |
|
$ |
(47,432 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) per share - basic and diluted |
$ |
(0.74 |
) |
|
$ |
(0.64 |
) |
|
|
$ |
(2.15 |
) |
|
$ |
(2.45 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares |
|
|
|
|
|
|
|
|
|
outstanding - basic and diluted |
|
25,031,478 |
|
|
|
23,646,192 |
|
|
|
|
24,992,229 |
|
|
|
19,335,541 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE THERAPEUTICS, INC. |
|
Condensed Consolidated Balance Sheets |
|
(In thousands, except for share and per share
amounts) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
|
|
|
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
20,914 |
|
|
$ |
60,599 |
|
|
Accounts
receivable, net |
|
10,316 |
|
|
6,481 |
|
|
Inventories,
net |
|
4,124 |
|
|
5,441 |
|
|
Prepaid expenses
and other current assets |
|
2,706 |
|
|
1,680 |
|
|
|
|
|
|
Total current
assets |
|
38,060 |
|
|
74,201 |
|
Property and
equipment, net |
|
10,351 |
|
|
12,207 |
|
Intangible assets,
net |
|
165 |
|
|
204 |
|
Other
assets |
|
242 |
|
|
239 |
|
|
|
|
|
|
Total assets |
|
$ |
48,818 |
|
|
$ |
86,851 |
|
Liabilities and shareholders'
(deficit)/equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts payable
and accrued expenses |
|
$ |
19,218 |
|
|
$ |
27,631 |
|
|
Deferred revenue,
current |
|
835 |
|
|
721 |
|
|
Loans payable,
current |
|
- |
|
|
4,600 |
|
|
|
|
|
|
Total current
liabilities |
|
20,053 |
|
|
32,952 |
|
Loans payable,
net |
|
59,775 |
|
|
42,603 |
|
Deferred revenue,
net of current portion |
|
2,127 |
|
|
- |
|
Asset retirement
obligations |
|
1,322 |
|
|
1,216 |
|
|
|
|
|
|
Total
liabilities |
|
83,277 |
|
|
76,771 |
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders’
(deficit)/equity: |
|
|
|
|
|
|
|
Common stock,
$.001 par value. Authorized 250,000,000 shares; 25,042,964 and
24,957,309 |
|
|
|
|
|
|
|
|
shares
issued and outstanding at September 30, 2019 and December 31, 2018,
respectively |
|
25 |
|
|
25 |
|
|
Additional paid-in
capital |
|
83,354 |
|
|
71,431 |
|
|
Accumulated
deficit |
|
(117,838 |
) |
|
(61,376 |
) |
|
|
|
|
|
Total
shareholders' (deficit)/equity |
|
(34,459 |
) |
|
10,080 |
|
|
|
|
|
|
Total liabilities
and shareholders' (deficit) /equity |
|
$ |
48,818 |
|
|
$ |
86,851 |
|
AQUESTIVE
THERAPEUTICS, INC. |
|
Reconciliation of Non-GAAP Adjustments - GAAP Costs and
Expenses to Adjusted Costs and Expenses |
|
(In
Thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
|
|
September
30, |
|
September
30, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
Total Costs and Expenses |
$ |
23,420 |
|
|
$ |
22,472 |
|
|
$ |
78,954 |
|
|
$ |
87,189 |
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
Compensation Expense |
|
(1,869 |
) |
|
|
(1,236 |
) |
|
|
(5,199 |
) |
|
|
(28,541 |
) |
|
|
|
Depreciation
and Amortization |
|
(707 |
) |
|
|
(746 |
) |
|
|
(2,182 |
) |
|
|
(2,476 |
) |
|
Adjusted Costs and Expenses |
$ |
20,844 |
|
|
$ |
20,490 |
|
|
$ |
71,573 |
|
|
$ |
56,172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
|
Reconciliation of Non-GAAP Adjustments - GAAP Manufacture
and Supply Expense to Adjusted Manufacture and Supply
Expense |
|
(In
Thousands, except percentages) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
|
|
September
30, |
|
September
30, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
Manufacture and Supply Expense |
$ |
4,643 |
|
|
$ |
5,592 |
|
|
$ |
13,569 |
|
|
$ |
16,201 |
|
|
|
|
Gross Margin
on total revenue |
|
63 |
% |
|
|
58 |
% |
|
|
63 |
% |
|
|
68 |
% |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
Share-based
Compensation Expense |
|
(60 |
) |
|
|
(32 |
) |
|
|
(176 |
) |
|
|
(377 |
) |
|
|
|
Depreciation
and Amortization |
|
(572 |
) |
|
|
(602 |
) |
|
|
(1,765 |
) |
|
|
(2,003 |
) |
|
Adjusted Manufacture and Supply Expense |
$ |
4,011 |
|
|
$ |
4,958 |
|
|
$ |
11,628 |
|
|
$ |
13,821 |
|
|
|
|
Non-GAAP
Gross Margin on total revenue |
|
68 |
% |
|
|
63 |
% |
|
|
68 |
% |
|
|
73 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
|
Reconciliation of Non-GAAP Adjustments - GAAP Research and
Development Expense to Adjusted Research and Development
Expense |
|
(In
Thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
|
|
September
30, |
|
September
30, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
Research and Development Expense |
$ |
5,063 |
|
|
$ |
4,534 |
|
|
$ |
17,517 |
|
|
$ |
17,429 |
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
Share-based
Compensation Expense |
|
(187 |
) |
|
|
(192 |
) |
|
|
(535 |
) |
|
|
(2,378 |
) |
|
|
|
Depreciation
and Amortization |
|
(79 |
) |
|
|
(117 |
) |
|
|
(200 |
) |
|
|
(259 |
) |
|
Adjusted Research and Development Expense |
$ |
4,797 |
|
|
$ |
4,225 |
|
|
$ |
16,782 |
|
|
$ |
14,792 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
|
Reconciliation of Non-GAAP Adjustments - GAAP Selling,
General and Administrative Expenses to Adjusted Selling, General
and Administrative Expenses |
|
(In
Thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
|
|
September
30, |
|
September
30, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
Selling, General and Administrative Expenses |
$ |
13,714 |
|
|
$ |
12,346 |
|
|
$ |
47,868 |
|
|
$ |
53,559 |
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
Share-based
Compensation Expense |
|
(1,622 |
) |
|
|
(1,012 |
) |
|
|
(4,488 |
) |
|
|
(25,786 |
) |
|
|
|
Depreciation
and Amortization |
|
(57 |
) |
|
|
(27 |
) |
|
|
(217 |
) |
|
|
(214 |
) |
|
Adjusted Selling, General and Administrative Expenses |
$ |
12,035 |
|
|
$ |
11,307 |
|
|
$ |
43,163 |
|
|
$ |
27,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
|
Reconciliation of Non-GAAP Adjustments - Net Loss to
Adjusted EBITDA |
|
(In
Thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
|
|
|
|
September
30, |
|
September
30, |
|
|
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
$ |
(18,412 |
) |
|
$ |
(15,038 |
) |
|
$ |
(53,610 |
) |
|
$ |
(47,432 |
) |
|
|
Share-based Compensation Expense |
|
|
1,869 |
|
|
|
1,236 |
|
|
|
5,199 |
|
|
|
28,541 |
|
|
|
Interest Expense, net |
|
|
|
2,514 |
|
|
|
1,717 |
|
|
|
5,950 |
|
|
|
5,571 |
|
|
|
Income Taxes |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
Depreciation and Amortization |
|
|
707 |
|
|
|
746 |
|
|
|
2,182 |
|
|
|
2,476 |
|
|
|
Loss on Extinguishment of Debt |
|
|
4,896 |
|
|
|
- |
|
|
|
4,896 |
|
|
|
- |
|
|
|
Change in Fair Value of Warrant |
|
|
- |
|
|
|
4,116 |
|
|
|
- |
|
|
|
5,278 |
|
|
Adjusted EBITDA |
|
|
$ |
(8,426 |
) |
|
$ |
(7,223 |
) |
|
$ |
(35,383 |
) |
|
$ |
(5,566 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor inquiries: Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
Media inquiriesMark Corbaemark.corbae@icrinc.com203-682-8288
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