Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, announced today reported financial results for the second
quarter ended June 30, 2020 and provided an update
on recent developments in its business.
Keith J. Kendall, President and Chief Executive
Officer of Aquestive, stated, “While continuing to navigate
the health crisis caused by the COVID-19 pandemic and, to the best
of our ability, fulfilling our responsibility to keep our
colleagues and neighbors safe, we are advancing the important work
of the Company, as expected, and ensuring the medications our
patients depend on each day remain available to them without
interruption. We are pleased that Sympazan continued its
commercial growth during the second quarter. Also, in July
2020, the FDA accepted our IND for AQST-108, our drug candidate in
development to deliver systemic epinephrine for the treatment of
anaphylaxis, and we are progressing toward commencing our planned
PK trials expected later in the third quarter of this year.
Concurrently, we are continuing to advance through the FDA review
process for our product candidate, Libervant™ (diazepam) Buccal
Film for the management of seizure clusters, including providing
information to the agency, responding to its information requests
and working with the agency on its inspection of our manufacturing
and clinical investigational sites. With the commercial
foundation we have built for Sympazan, we will be prepared to
launch Libervant quickly, if approved by the FDA for U.S. marketing
access. The formal process for a potential monetization of
our KYNMOBI royalty asset is ongoing.”
Proprietary Pipeline Overview and
Business UpdateAquestive is building a portfolio of
differentiated therapeutics 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 proprietary
products and late-stage product candidates are initially focused on
CNS conditions and other patient populations with high unmet
need.
- Aquestive submitted an
Investigational New Drug (IND) application on June 26, 2020 to the
U.S. Food and Drug Administration (FDA) for PK clinical trials of
its drug candidate AQST-108, a “first of its kind” oral sublingual
film formulation delivering systemic epinephrine that is in
development for the treatment of anaphylaxis using Aquestive’s
proprietary PharmFilm® technologies. As proposed by Aquestive
and confirmed by the FDA at the pre-IND meeting held in February
2020, the clinical development for AQST-108 will be reviewed under
the 505(b)(2) regulatory approval pathway. On July 23, 2020,
Aquestive received confirmation from the FDA that the agency had
completed its safety review of the IND and concluded that the
Company could proceed with the first planned PK clinical trials of
AQST-108. The Company expects to commence a crossover study
to compare the pharmacokinetics and pharmacodynamics of epinephrine
administered as sublingual film to that of epinephrine administered
as an injection before the end of the third quarter of 2020.
- Aquestive is engaging as
expected with the FDA related to its New Drug Application
(NDA) for Libervant™ (diazepam) Buccal Film for the
management of seizure clusters. The review to date has
progressed with our providing information to the agency, responding
to its information requests and working with the agency on its
inspections of the Company’s manufacturing and clinical
investigational sites. The Company expects that it will
continue to have exchanges with the FDA as the September 27, 2020
Prescription Drug User Fee Act (PDUFA) goal date approaches.
Aquestive is seeking to demonstrate to the FDA
that Libervant will, if approved by the FDA for marketing
in the U.S., represent a “major contribution to patient care”
within the meaning of FDA regulations and guidance as compared to
currently available treatment options, and further expand patient
choice as the only orally delivered and non-device
driven diazepam-based therapy available to manage seizure
clusters in epilepsy patients. Although we cannot assure FDA
approval of Libervant for U.S. marketing access, we remain
committed to helping epilepsy patients affected by seizure clusters
by working to bring innovative products to the market.
- Sympazan® (clobazam), an oral film
for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) and launched as a precursor and
complement to Libervant, continues to progress on key
performance commercialization metrics including quarterly growth in
retail shipments, number of prescribers, repeat prescribers, and
covered lives, with the goal of helping prepare
the market for a launch of Libervant, if approved by the
FDA for marketing in the U.S.
- KYNMOBI, an apomorphine thin film
therapy for the treatment of off episodes in Parkinson’s disease
patients, is licensed by the Company to Sunovion Pharmaceuticals,
Inc. KNYMOBI received FDA approval on May 21, 2020. Under the
terms of the license agreement with Sunovion, Aquestive is entitled
to receive certain milestone payments and ongoing royalties on the
world-wide net sales of KYNMOBI. The Company is in the
process of seeking to monetize this asset. The formal process for a
potential monetization of the Company’s KYNMOBI royalty asset is
ongoing.
Second Quarter
2020 FinancialsTotal revenues were $21.7 million
in the second quarter 2020, compared to $11.1 million in the
second quarter 2019. This year-over-year increase reflected
license fees and royalty revenue in the second quarter of 2020
primarily related to $12 million recognized as a result of the
KYNMOBI approval, of which $8 million is non-cash revenue related
to minimum royalties that will be received over future years.
In addition, Aquestive saw revenue growth in the second quarter of
2020 compared to the prior year period of 59% for Sympazan,
the first of its proprietary products to be launched, offset in
part, by lower year-over-year performance of Suboxone®.
Aquestive’s net loss for the second quarter
2020 was $2.3 million, or $0.07 loss per share. The net loss
for the second quarter 2019 was $20.5 million, or
$0.82 loss per share. The change in net loss was
driven by higher revenue and reductions in costs and expenses,
primarily in research and development and selling, general and
administrative expenses in the second quarter 2020, compared to
the second quarter 2019, partially offset by higher
interest expense.
Earnings before interest, taxes, depreciation
and amortization, share-based compensation and other adjustments
(adjusted EBITDA) was $2.9 million in the
second quarter 2020, compared to $16.2 million of losses
in the comparable prior period. The year-over-year change
in adjusted EBITDA was driven primarily
by higher revenue and reductions in costs and expenses,
primarily in research and development and selling, general and
administrative expenses in the second quarter 2020, compared to the
second quarter 2019, partially offset by higher interest
expense.
As of June 30, 2020, cash and cash
equivalents were $25.4 million.
2020 Outlook Aquestive is
re-affirming its full year 2020 financial outlook. The
Company’s full year guidance does not include the revenue
recognized this quarter as a result of minimum royalty payments
that will be received over future years from KYNMOBI.
The Company expects:
- Total revenues of approximately $35 million to $45
million
- No Libervant revenues are included in the Company’s 2020
guidance
- Non-GAAP adjusted gross margins of approximately 70% to 75% on
total revenues
- Non-GAAP adjusted EBITDA loss of approximately $45 million to
$50 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 Wednesday, August 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: 6069891.
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. Aquestive is advancing
a late-stage proprietary product pipeline to treat CNS and other
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
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, 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. Similarly, manufacturing
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 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 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 Outlook In
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. In order
to inform our outlook measures of non-GAAP adjusted EBITDA and
non-GAAP gross margin, a description of the 2019 and
2020 adjustments which have been applicable in
determining non-GAAP Adjusted EBITDA and non-GAAP
gross margin for these periods are reflected in
the tables below. In providing outlook for non-GAAP gross
margin, 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, Libervant™ and our other product candidates; ability
to obtain FDA approval and advance AQST-108, Libervant and our
other product candidates to the market, statements about our growth
and future financial and operating results and financial position,
regulatory approval and pathways, 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 and uncertainties concerning any
potential monetization of royalty and other revenue stream of
KYNMOBI (apomorphine), including timing, structure, terms and
market conditions of any such potential monetization and of
sufficiency of net proceeds of any such monetization after
satisfaction of and compliance with 12.5% Senior Notes obligations,
as applicable; 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 sales, 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 |
|
|
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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 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:Stephanie
Carringtonstephanie.carington@icrinc.com646-277-1282
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AQUESTIVE THERAPEUTICS, INC. |
Condensed Consolidated Balance Sheets |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
|
June 30, |
|
December 31, |
|
Assets |
|
2020 |
|
2019 |
|
|
|
|
|
|
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Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ 25,422 |
|
$ 49,326 |
|
Trade and other receivables, net |
|
12,891 |
|
13,130 |
|
Inventories, net |
|
3,173 |
|
2,859 |
|
Prepaid expenses and other current assets |
|
2,423 |
|
2,999 |
|
|
Total current assets |
|
43,909 |
|
68,314 |
|
Property and equipment, net |
|
8,457 |
|
9,726 |
|
Right-of-use asset, net |
|
3,764 |
|
- |
|
Intangible assets, net and other assets |
|
7,416 |
|
439 |
|
|
Total assets |
|
$ 63,546 |
|
$ 78,479 |
|
|
|
|
|
|
|
Liabilities and stockholders' deficit |
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ 13,390 |
|
$ 17,749 |
|
Lease liabilities, current |
|
689 |
|
- |
|
Deferred revenue, current |
|
803 |
|
806 |
|
|
Total current liabilities |
|
14,882 |
|
18,555 |
|
Loans payable, net |
|
61,505 |
|
60,338 |
|
Lease liabilities |
|
3,240 |
|
- |
|
Deferred revenue, net of current |
|
3,867 |
|
4,348 |
|
Asset retirement obligations |
|
1,440 |
|
1,360 |
|
|
Total liabilities |
|
84,934 |
|
84,601 |
|
Contingencies |
|
|
|
|
|
|
|
|
|
|
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Stockholders' deficit: |
|
|
|
|
|
Common stock, $.001 par value. Authorized 250,000,000 shares;
33,616,601 and |
|
|
|
|
33,562,885 shares issued and outstanding at June 30, 2020 and
December 31, 2019, |
|
|
|
respectively |
|
34 |
|
34 |
|
Additional paid-in capital |
|
127,916 |
|
124,318 |
|
Accumulated deficit |
|
(149,338) |
|
(130,474) |
|
|
Total stockholders' deficit |
|
(21,388) |
|
(6,122) |
|
|
Total liabilities and stockholders' deficit |
|
$ 63,546 |
|
$ 78,479 |
|
|
|
|
|
|
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AQUESTIVE THERAPEUTICS, INC. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(In thousands, except share and per share data
amounts) |
(Unaudited) |
|
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|
|
|
|
|
|
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Three Months Ended |
|
Six Months Ended |
|
|
|
|
June 30, |
|
June 30, |
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
21,675 |
|
|
$ |
11,129 |
|
|
$ |
30,440 |
|
|
$ |
23,772 |
|
Costs and Expenses: |
|
|
|
|
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|
|
|
Manufacture and supply |
|
|
3,539 |
|
|
|
5,420 |
|
|
|
7,198 |
|
|
|
8,926 |
|
|
Research and development |
|
|
3,847 |
|
|
|
8,151 |
|
|
|
8,201 |
|
|
|
12,454 |
|
|
Selling, general and administrative |
|
|
13,894 |
|
|
|
16,246 |
|
|
|
28,507 |
|
|
|
34,154 |
|
|
|
Total costs and expenses |
|
|
21,280 |
|
|
|
29,817 |
|
|
|
43,906 |
|
|
|
55,534 |
|
|
|
Income (loss) from operations |
|
|
395 |
|
|
|
(18,688 |
) |
|
|
(13,466 |
) |
|
|
(31,762 |
) |
Other income/(expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2,747 |
) |
|
|
(1,937 |
) |
|
|
(5,518 |
) |
|
|
(3,863 |
) |
|
Interest income |
|
|
18 |
|
|
|
153 |
|
|
|
120 |
|
|
|
427 |
|
|
Net loss before income taxes |
|
|
(2,334 |
) |
|
|
(20,472 |
) |
|
|
(18,864 |
) |
|
|
(35,198 |
) |
|
Income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Net loss |
|
$ |
(2,334 |
) |
|
$ |
(20,472 |
) |
|
$ |
(18,864 |
) |
|
$ |
(35,198 |
) |
|
Comprehensive loss |
|
$ |
(2,334 |
) |
|
$ |
(20,472 |
) |
|
$ |
(18,864 |
) |
|
$ |
(35,198 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.82 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares |
|
|
|
|
|
|
|
|
|
outstanding - basic and diluted |
|
|
33,589,174 |
|
|
|
24,980,861 |
|
|
|
33,579,434 |
|
|
|
24,972,280 |
|
|
|
|
|
|
|
|
|
|
|
|
AQUESTIVE THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - Net Loss to
Adjusted EBITDA |
(In Thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
|
$ |
(2,334 |
) |
|
$ |
(20,472 |
) |
|
|
$ |
(18,864 |
) |
|
$ |
(35,198 |
) |
|
Share-based Compensation Expense |
|
|
1,765 |
|
|
|
1,810 |
|
|
|
3,625 |
|
|
|
3,330 |
|
|
Interest Expense, net |
|
|
2,729 |
|
|
|
1,784 |
|
|
|
5,398 |
|
|
|
3,436 |
|
|
Income Taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Depreciation and Amortization |
|
|
754 |
|
|
|
724 |
|
|
|
1,520 |
|
|
|
1,473 |
|
Total non-GAAP adjustmentss |
|
|
5,248 |
|
|
|
4,318 |
|
|
|
10,543 |
|
|
|
8,239 |
|
Adjusted EBITDA |
|
$ |
2,914 |
|
|
$ |
(16,154 |
) |
|
$ |
(8,321 |
) |
|
$ |
(26,959 |
) |
|
|
|
|
|
|
|
|
|
|
AQUESTIVE THERAPEUTICS, INC. |
Reconciliation of Non-GAAP Adjustments - GAAP Expenses to
Adjusted Expenses |
(In Thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Total costs and expenses |
$ |
21,280 |
|
|
$ |
29,817 |
|
|
$ |
43,906 |
|
|
$ |
55,534 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
(1,765 |
) |
|
|
(1,810 |
) |
|
|
(3,625 |
) |
|
|
(3,330 |
) |
|
|
Depreciation and amortization |
|
(754 |
) |
|
|
(724 |
) |
|
|
(1,520 |
) |
|
|
(1,473 |
) |
Adjusted costs and expenses |
$ |
18,761 |
|
|
$ |
27,283 |
|
|
$ |
38,761 |
|
|
$ |
50,731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Manufacture and Supply Expense |
$ |
3,539 |
|
|
$ |
5,420 |
|
|
$ |
7,198 |
|
|
$ |
8,926 |
|
|
|
Gross Margin on total revenue |
|
84 |
% |
|
|
51 |
% |
|
|
76 |
% |
|
|
62 |
% |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
(72 |
) |
|
|
(72 |
) |
|
|
(135 |
) |
|
|
(116 |
) |
|
|
Depreciation and amortization |
|
(617 |
) |
|
|
(586 |
) |
|
|
(627 |
) |
|
|
(1,193 |
) |
Adjusted manufacture and supply expense |
$ |
2,850 |
|
|
$ |
4,762 |
|
|
$ |
6,436 |
|
|
$ |
7,617 |
|
|
|
Non-GAAP Gross Margin on total revenue |
|
87 |
% |
|
|
57 |
% |
|
|
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 |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Research and Development Expense |
$ |
3,847 |
|
|
$ |
8,151 |
|
|
$ |
8,201 |
|
|
$ |
12,454 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
(183 |
) |
|
|
(140 |
) |
|
|
(365 |
) |
|
|
(348 |
) |
|
|
Depreciation and amortization |
|
(59 |
) |
|
|
(60 |
) |
|
|
(60 |
) |
|
|
(121 |
) |
Adjusted research and development expense |
$ |
3,605 |
|
|
$ |
7,951 |
|
|
$ |
7,776 |
|
|
$ |
11,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Selling, General and Administrative Expenses |
$ |
13,894 |
|
|
$ |
16,246 |
|
|
$ |
28,507 |
|
|
$ |
34,154 |
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
(1,510 |
) |
|
|
(1,598 |
) |
|
|
(3,125 |
) |
|
|
(2,866 |
) |
|
|
Depreciation and amortization |
|
(78 |
) |
|
|
(78 |
) |
|
|
(79 |
) |
|
|
(159 |
) |
Adjusted selling, general and administrative expenses |
$ |
12,306 |
|
|
$ |
14,570 |
|
|
$ |
25,303 |
|
|
$ |
31,129 |
|
|
|
|
|
|
|
|
|
|
|
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