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, 2020 and provided an
update on recent developments in its business.
“Amidst the unprecedented uncertainty of the
COVID-19 pandemic, our Company has made progress this quarter in
advancing our CNS product portfolio and other important
therapeutics in our product pipeline, highlighted by the completion
of dosing in a Phase 1 pharmacokinetic trial for our product
candidate AQST-108, a “first of its kind” oral sublingual film
formulation delivering systemic epinephrine, and we are on track to
assess the validity and quality of that data in the coming weeks,”
said Keith J. Kendall, President and Chief Executive Officer of
Aquestive. “Importantly, we are advancing our lead product
candidate, Libervant™ (diazepam) Buccal Film for the management of
seizure clusters, through the approval process with the Food and
Drug Administration (FDA). We received confirmation from the FDA
that, after submitting our meeting package this past October, a
review meeting with the Agency is set for November 12, 2020. We
look forward to working with the FDA in seeking feedback and
clarity on the pathway for approval of Libervant. Moreover, the
KYNMOBI royalty monetization transaction, which was signed this
week and is expected to close and fund later this month, provides
the Company with substantial capital to support our key clinical
and commercial initiatives and reduce our senior debt,” concluded
Mr. Kendall.
Despite 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
sequentially quarter over quarter has grown 18% and by 130% over
the same period last year. During the third quarter 2020, Sympazan
saw continued growth in the prescriber base, approaching 700
healthcare providers, which represents over 26% penetration into
the Company’s focused group of prescribers, with over 77% of those
prescribers writing multiple scripts. Sympazan net revenue grew
102% for the three month period ended September 30, 2020 versus the
same period last year, and 86% for the nine month period ended
September 30, 2020 versus the same period last year. Sympazan
currently has over 72% of commercial lives covered and an 82%
coverage of State Medicaid regions. Given the substantial overlap
of prescribers, Sympazan is strategically accomplishing what was
intended when it was developed and launched last year, to build an
important foundation for a successful launch of Libervant, if
approved by the FDA for U.S. market access.
As indicated in the Company’s investor call on
September 25, 2020, the Company submitted in October the data and
information it believes addresses the FDA’s concerns expressed in
the FDA’s Complete Response Letter relating to Libervant. The
Company received confirmation that the FDA agreed to a Type A
meeting with the Company to be held on November 12, 2020. A Type A
meeting is granted for candidate drugs on hold to discuss impeding
issues and a path forward for approval. Based on the data and
information submitted to the FDA, the Company does not believe at
this time that further clinical studies are necessary. At that
meeting, the Company expects to discuss the information submitted
in the October 2020 meeting package and to seek to confirm the
pathway for approval and propose the immediate resubmission of the
NDA for Libervant. If the FDA agrees with the Company’s proposal,
then the Company plans on resubmitting the NDA before the end of
the year. If the FDA does not agree with the Company’s proposal,
then the Company will seek to understand the best path forward for
resubmission and approval. The Company will update the market
regarding the FDA’s comments, the Company’s plans for resubmitting
the NDA, and the potential range of PDUFA dates for Libervant once
meeting minutes are finalized.
After receiving Fast Track Designation from the FDA
for AQST-108, the Company completed enrollment and dosing of 28
healthy volunteers in a Phase 1 pharmacokinetic (PK) trial for
AQST-108 in October 2020. The trial features a four-treatment
crossover design comparing the pharmacokinetics and
pharmacodynamics of AQST-108, 0.3 mg of epinephrine subcutaneous
injection (subQ), 0.3 mg of epinephrine intramuscular (IM)
injection, and 0.5 mg epinephrine subQ. The study includes
secondary endpoints for changes in blood pressure and heart rate.
The Company is on track to assess the validity and quality of that
data in the coming weeks. The Company believes that AQST-108, if
approved by the FDA, will be the first orally administered
epinephrine-based rescue medication for this patient
population.
As previously announced, this week the Company
signed a monetization agreement for up to $125 million for its
worldwide royalty rights in KYNMOBI™ (apomorphine HCI) sublingual
film for the acute, intermittent treatment of OFF episodes in
patients with Parkinson’s disease, which received approval from the
FDA on May 21, 2020. The Company expects to close and fund the
monetization transaction later this month. Under the terms of the
monetization agreement, the Company will receive at closing of the
transaction $40 million and is eligible to receive up to the
additional $85 million of contingent payments at various points,
beginning as early as the fourth quarter of 2020, based on the
achievement of worldwide royalty targets and certain other
commercial milestones. This includes up to $25 million potentially
available between now and mid-2022. The net proceeds of the
transaction will be used to repay certain senior notes and fund the
Company’s ongoing development and commercialization of its
proprietary product and pipeline candidates, as well as for working
capital purposes. In connection with the monetization transaction,
the Company will repay $22.5 million of its senior notes and issue
$4.0 million of new senior notes in lieu of paying a prepayment
premium on the early repayment of the senior notes, bringing the
Company’s outstanding senior debt from $70 million to $51.5
million, and reducing the principal and interest obligations under
the senior note debt facility in the future.
Third Quarter
2020 FinancialsTotal revenues were $8.3 million in
the third quarter 2020, compared to $12.4 million in the third
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 saw revenue growth in the third quarter 2020
compared to the prior year period of 102% for Sympazan, the
first of its proprietary products to be launched.
Aquestive’s net loss for the third quarter
2020 was $16.6 million, or $0.49 loss per share. The net loss
for the third quarter 2019 was $18.4 million, or
$0.74 loss per share. The change in net loss was
driven by lower revenue and reductions in costs and expenses,
primarily in manufacture and supply expense reflecting the lower
volume of production in the third quarter 2020, compared to
the third quarter 2019. In addition, the third quarter
of 2019 included a $4.9 million loss on extinguishment of debt.
Non GAAP adjusted loss before interest, taxes,
depreciation and amortization, share-based compensation and other
adjustments (adjusted EBITDA loss) was $11.6 million in the
third quarter 2020, compared to $8.4 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
third quarter 2020, compared to the third quarter
2019.
As of September 30, 2020, cash and cash
equivalents were $17.1 million.
2020 Outlook Aquestive is
updating its full year 2020 financial outlook. The Company’s full
year guidance does not include the accounting for the monetization
of the KYNMOBI royalty stream.
The Company expects:
- Total revenues of approximately $42 million to $46
million
- Non-GAAP adjusted gross margins of approximately 70% to 75% on
total revenues
- Non-GAAP adjusted EBITDA loss of approximately $38 million to
$42 million
- Cash burn of approximately $45 million to $50 million
The novel coronavirus pandemic continues to evolve
and the extent to which it may impact Aquestive’s ongoing and
future business operations, financial results and resources, or the
success of the Company’s commercial and candidate products,
including Libervant, will depend on future developments which are
uncertain.
Tomorrow’s Conference Call and Webcast
Reminder The Company will host a conference call at
8:00 a.m. ET on Thursday, November 5, 2020. 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: 8266119.
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 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, interest expense,
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, interest income 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 Outlook In 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 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
include, but are not limited to, statements regarding therapeutic
benefits and plans and objectives for regulatory approvals of
AQST-108 and Libervant; 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; ability to obtain FDA
approval and advance AQST-108, Libervant and our other product
candidates to the market; about our growth and future financial and
operating results and financial position; regulatory approval and
pathway; clinical trial timing and plans; 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;
business strategies, market opportunities, and other statements
that are not historical facts. These forward-looking statements are
also 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 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; risk of delays in FDA
approval of Libervant 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 inherent in
commercializing a new product (including technology risks,
financial risks, market risks and implementation risks and
regulatory limitations); risks for consummating the monetization
transaction for KYNMOBI and other risks and uncertainties
concerning the royalty and other revenue stream of KYNMOBI,
achievement of royalty targets worldwide or in any jurisdiction and
certain other commercial targets required for contingent payments
under the monetization transaction, and of sufficiency of net
proceeds of the monetization transaction after satisfaction of and
compliance with 12.5% Senior Notes obligations, as applicable, and
for funding the Company’s operations; 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; 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,
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.
Additional Information Regarding FDA
Regulations and Guidance on “Major Contribution to
Patient Care”The FDA’s response to the Company’s Citizen’s
Petition dated November 1, 2019 includes the following in
discussing orphan drug exclusivity, including pertinent factors
that may be considered by the FDA in making a determination of
“major contribution to patient care” for “clinical superiority” as:
convenient treatment location; duration of treatment; patient
comfort; reduced treatment burden; advances in ease and comfort of
drug administration; longer periods between doses; and potential
for self-administration:
Section 527 of the Federal Food, Drug, and Cosmetic
Act defines “clinically superior” to mean “the drug provides a
significant therapeutic advantage over and above an already
approved or licensed drug in terms of greater efficacy, greater
safety, or by providing a major contribution to patient care.” The
orphan-drug regulations elaborate on the definition of “clinically
superior” as follows:
Clinically superior means that a drug is shown to
provide a significant therapeutic advantage over and above that
provided by an approved drug (that is otherwise the same drug) in
one or more of the following ways:
|
Greater
effectiveness than an approved drug (as assessed by effect on a
clinically meaningful endpoint in adequate and well controlled
clinical trials). Generally, this would represent the same kind of
evidence needed to support a comparative effectiveness claim for
two different drugs; in most cases, direct comparative clinical
trials would be necessary; or |
|
|
|
Greater safety in a substantial portion of the target
populations, for example, by the elimination of an ingredient or
contaminant that is associated with relatively frequent adverse
effects. In some cases, direct comparative clinical trials will be
necessary; or In unusual cases, where neither greater safety nor
greater effectiveness has been shown, a demonstration that the drug
otherwise makes a major contribution to patient care. |
Because of the diverse ways in which drugs may
qualify as clinically superior under these criteria, FDA evaluates
clinical superiority on a case by case basis. Specifically, with
respect to the major contribution to patient care prong of the
clinical superiority definition, the FDA has further stated:
|
There is no
way to quantify such superiority in a general way. The amount and
kind of superiority needed would vary depending on many factors,
including the nature and severity of the disease or condition, the
quality of the evidence presented, and diverse other factors;
and |
|
|
|
The following factors, when applicable to severe or
life-threatening diseases, may in appropriate cases be taken into
consideration when determining whether a drug makes a major
contribution to patient care: convenient treatment location;
duration of treatment; patient comfort; reduced treatment burden;
advances in ease and comfort of drug administration; longer periods
between doses; and potential for self-administration. |
Although FDA approval for U.S. market access cannot
be assured, Aquestive remains committed to helping epilepsy
patients affected by seizure clusters by working to bring
innovative products to the market.
____________________________________________________________________________________ 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.
SYMPAZAN IMPORTANT SAFETY
INFORMATION BOXED WARNING: RISKS FROM CONCOMITANT USE
WITH OPIOIDS Concomitant 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.
CONTRAINDICATIONS SYMPAZAN is contraindicated
in patients with a history of hypersensitivity to the drug or its
ingredients. Hypersensitivity reactions have included serious
dermatological reactions.
WARNINGS AND PRECAUTIONS Potentiation of
Sedation from Concomitant Use with Central Nervous System (CNS)
Depressants SYMPAZAN 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 Sedation SYMPAZAN 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 Symptoms Abrupt 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 Reactions Serious 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 Dependence Patients
with a history of substance abuse should be under careful
surveillance when receiving SYMPAZAN.
Suicidal Behavior and Ideation AEDs, 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 REACTIONS Adverse reactions (≥10% and
more frequently than placebo) included constipation, somnolence or
sedation, pyrexia, lethargy, and drooling.
DRUG INTERACTIONS The 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 POPULATIONS Pregnancy 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.
Investor inquiries:
Westwicke, an ICR CompanyStephanie
Carringtonstephanie.carington@westwicke.com646-277-1282
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AQUESTIVE THERAPEUTICS, INC. |
Condensed Consolidated Balance Sheets |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
Assets |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
17,064 |
|
$ |
49,326 |
|
|
Trade and other receivables, net |
|
7,990 |
|
13,130 |
|
|
Inventories, net |
|
3,242 |
|
2,859 |
|
|
Prepaid expenses and other current assets |
|
3,388 |
|
2,999 |
|
|
|
Total current assets |
|
31,684 |
|
68,314 |
|
|
Property and equipment, net |
|
7,728 |
|
9,726 |
|
|
Right-of-use asset, net |
|
3,609 |
|
- |
|
|
Intangible assets, net and other assets |
|
7,402 |
|
439 |
|
|
|
Total assets |
|
$ |
50,423 |
|
$ |
78,479 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' deficit |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
15,237 |
|
$ |
17,749 |
|
|
Lease liabilities, current |
|
664 |
|
- |
|
|
Loans payable, current |
|
1,750 |
|
- |
|
|
Deferred revenue, current |
|
722 |
|
806 |
|
|
|
Total current liabilities |
|
18,373 |
|
18,555 |
|
|
Loans payable, net |
|
60,346 |
|
60,338 |
|
|
Lease liabilites |
|
3,047 |
|
- |
|
|
Deferred revenue, net of current |
|
3,694 |
|
4,348 |
|
|
Asset retirement obligations |
|
1,482 |
|
1,360 |
|
|
|
Total liabilities |
|
86,942 |
|
84,601 |
|
|
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' deficit: |
|
|
|
|
|
|
Common stock, $.001 par value. Authorized 250,000,000 shares;
33,619,796 and |
|
|
|
|
|
|
33,562,885 shares issued and outstanding at September 30, 2020 and
December 31, 2019, |
|
|
|
|
|
|
|
respectively |
|
34 |
|
34 |
|
|
Additional paid-in capital |
|
129,336 |
|
124,318 |
|
|
Accumulated deficit |
|
(165,889) |
|
(130,474) |
|
|
|
Total stockholders' deficit |
|
(36,519) |
|
(6,122) |
|
|
|
Total liabilities and stockholders' deficit |
|
$ |
50,423 |
|
$ |
78,479 |
|
|
|
|
|
|
|
|
|
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, |
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
$ |
8,260 |
|
|
$ |
12,418 |
|
|
|
$ |
38,700 |
|
|
$ |
36,190 |
|
Costs and Expenses: |
|
|
|
|
|
|
|
|
|
|
|
Manufacture and supply |
|
|
|
2,978 |
|
|
|
4,643 |
|
|
|
|
10,176 |
|
|
|
13,569 |
|
|
Research and development |
|
|
|
7,260 |
|
|
|
5,063 |
|
|
|
|
15,461 |
|
|
|
17,517 |
|
|
Selling, general and administrative |
|
|
|
11,803 |
|
|
|
13,714 |
|
|
|
|
40,310 |
|
|
|
47,868 |
|
|
Total costs and expenses |
|
|
|
22,041 |
|
|
|
23,420 |
|
|
|
|
65,947 |
|
|
|
78,954 |
|
|
Loss from operations |
|
|
|
(13,781 |
) |
|
|
(11,002 |
) |
|
|
|
(27,247 |
) |
|
|
(42,764 |
) |
Other income (expenses): |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
(2,778 |
) |
|
|
(2,652 |
) |
|
|
|
(8,296 |
) |
|
|
(6,515 |
) |
|
Interest income |
|
|
|
8 |
|
|
|
138 |
|
|
|
|
128 |
|
|
|
565 |
|
|
Loss on extinguishment of debt |
|
|
|
- |
|
|
|
(4,896 |
) |
|
|
|
- |
|
|
|
(4,896 |
) |
|
Net loss before income taxes |
|
|
|
(16,551 |
) |
|
|
(18,412 |
) |
|
|
|
(35,415 |
) |
|
|
(53,610 |
) |
|
Income taxes |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
Net loss |
|
|
$ |
(16,551 |
) |
|
$ |
(18,412 |
) |
|
|
$ |
(35,415 |
) |
|
$ |
(53,610 |
) |
|
Comprehensive loss |
|
|
$ |
(16,551 |
) |
|
$ |
(18,412 |
) |
|
|
$ |
(35,415 |
) |
|
$ |
(53,610 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
|
$ |
(0.49 |
) |
|
$ |
(0.74 |
) |
|
|
$ |
(1.05 |
) |
|
$ |
(2.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares |
|
|
|
|
|
|
|
|
|
|
outstanding - basic and diluted |
|
|
|
33,619,379 |
|
|
|
25,031,478 |
|
|
|
|
33,592,846 |
|
|
|
24,992,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - Net Loss to
Adjusted EBITDA |
(In Thousands) |
(Unaudited) |
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
Sept 30, |
|
Sept 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
|
$ |
(16,551 |
) |
|
$ |
(18,412 |
) |
|
$ |
(35,415 |
) |
|
$ |
(53,610 |
) |
Share-based Compensation Expense |
|
|
1,427 |
|
|
|
1,869 |
|
|
|
5,052 |
|
|
|
5,199 |
|
Interest Expense, net |
|
|
2,770 |
|
|
|
2,514 |
|
|
|
8,168 |
|
|
|
5,950 |
|
Income Taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Depreciation and Amortization |
|
|
766 |
|
|
|
707 |
|
|
|
2,286 |
|
|
|
2,182 |
|
Loss on Extinguishment of Debt |
|
|
- |
|
|
|
4,896 |
|
|
|
- |
|
|
|
4,896 |
|
Total non-GAAP adjustmentss |
|
|
4,963 |
|
|
|
9,986 |
|
|
|
15,506 |
|
|
|
18,227 |
|
Adjusted EBITDA |
|
$ |
(11,588 |
) |
|
$ |
(8,426 |
) |
|
$ |
(19,909 |
) |
|
$ |
(35,383 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE
THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - GAAP Expenses to
Adjusted Expenses |
(In
Thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Total costs and expenses |
$ |
22,041 |
|
|
$ |
23,420 |
|
|
$ |
65,947 |
|
|
$ |
78,954 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based
compensation expense |
|
(1,427 |
) |
|
|
(1,869 |
) |
|
|
(5,052 |
) |
|
|
(5,199 |
) |
|
|
Depreciation
and amortization |
|
(766 |
) |
|
|
(707 |
) |
|
|
(2,286 |
) |
|
|
(2,182 |
) |
Adjusted costs and expenses |
$ |
19,848 |
|
|
$ |
20,844 |
|
|
$ |
58,609 |
|
|
$ |
71,573 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
Ended |
|
Nine Months
Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Manufacture and Supply Expense |
$ |
2,978 |
|
|
$ |
4,643 |
|
|
$ |
10,176 |
|
|
$ |
13,569 |
|
|
|
Gross Margin
on total revenue |
|
64 |
% |
|
|
63 |
% |
|
|
74 |
% |
|
|
63 |
% |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based
compensation expense |
|
(72 |
) |
|
|
(60 |
) |
|
|
(208 |
) |
|
|
(176 |
) |
|
|
Depreciation
and amortization |
|
(627 |
) |
|
|
(572 |
) |
|
|
(1,871 |
) |
|
|
(1,765 |
) |
Adjusted manufacture and supply expense |
$ |
2,279 |
|
|
$ |
4,011 |
|
|
$ |
8,097 |
|
|
$ |
11,628 |
|
|
|
Non-GAAP
Gross Margin on total revenue |
|
72 |
% |
|
|
68 |
% |
|
|
79 |
% |
|
|
68 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Research and Development Expense |
$ |
7,260 |
|
|
$ |
5,063 |
|
|
$ |
15,461 |
|
|
$ |
17,517 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based
compensation expense |
|
(178 |
) |
|
|
(187 |
) |
|
|
(543 |
) |
|
|
(535 |
) |
|
|
Depreciation
and amortization |
|
(60 |
) |
|
|
(79 |
) |
|
|
(179 |
) |
|
|
(200 |
) |
Adjusted research and development expense |
$ |
7,022 |
|
|
$ |
4,797 |
|
|
$ |
14,739 |
|
|
$ |
16,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Selling, General and Administrative Expenses |
$ |
11,803 |
|
|
$ |
13,714 |
|
|
$ |
40,310 |
|
|
$ |
47,868 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expense |
|
(1,176 |
) |
|
|
(1,622 |
) |
|
|
(4,301 |
) |
|
|
(4,488 |
) |
|
|
Depreciation
and amortization |
|
(79 |
) |
|
|
(57 |
) |
|
|
(236 |
) |
|
|
(217 |
) |
Adjusted selling, general and administrative expenses |
$ |
10,548 |
|
|
$ |
12,035 |
|
|
$ |
35,773 |
|
|
$ |
43,163 |
|
|
|
|
|
|
|
|
|
|
|
Aquestive Therapeutics (NASDAQ:AQST)
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