WARREN, N.J., Nov. 6, 2018 /PRNewswire/ -- Aquestive
Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical
company focused on identifying, developing and commercializing
differentiated products to address unmet medical needs, today
reported financial results for the third quarter ended September 30, 2018 and provided a business
update.
"Aquestive is the worldwide leader in delivering therapeutics on
oral film with our PharmFilm® technology. Over the past quarter, we
have met a number of key business milestones that position us well
to achieve our long-term vision for growth," said Keith J. Kendall, Chief Executive Officer of
Aquestive. "We are excited to continue advancing our pipeline and
building our CNS commercial franchise with the launch of
SYMPAZAN™. Late stage development of Libervant is also
advancing with the recent completion of the adult EMU study."
Pipeline Overview, Upcoming Milestones and Business
Update
Aquestive received U.S. FDA approval for SYMPAZAN (clobazam)
oral film for the adjunctive treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
SYMPAZAN previously received tentative FDA approval on August 31, 2018 and has now been approved based
on the expiration of the orphan drug exclusivity period for
ONFI®.
Aquestive completed a pharmacokinetic adult epilepsy monitoring
unit (EMU) study demonstrating that its investigational diazepam
buccal film (DBF) product candidate, tentatively named Libervant,
provides comparable bioavailability whether administered between
seizures (interictal) or during and shortly after seizures
(ictal/peri-ictal) in adult patients with poorly controlled
tonic-clonic seizures or focal seizures with impaired awareness.
DBF, a novel formulation of diazepam as a small, thin film strip
placed inside the cheek, is under development for the management of
selected patients with refractory epilepsy who require intermittent
use of diazepam to control episodes of increased seizure
activity.
The topline data from the adult EMU study will be presented as
two late-breaking poster presentations at the American Epilepsy
Society's Annual Meeting, being held from November 30 to December 4, 2018.
Aquestive recently reached agreement with the FDA to end the
swallowing study for AQST-117 (riluzole), an oral soluble film
formulation for the treatment of Amyotrophic Lateral Sclerosis, the
third late-stage CNS asset in its proprietary portfolio, sooner
than previously planned based on an analysis of the study's interim
data. Topline results are expected to be reported in late 2018 and
an NDA submission is expected in the first quarter of
2019.
Aquestive continues to make progress on its early stage complex
molecule development programs for anaphylaxis and acromegaly. The
Company expects to commence a Phase 1 proof of concept study during
2019 for AQST-108, its sublingual film formulation of epinephrine
in development for the treatment of anaphylaxis. During the third
quarter 2018, Aquestive commenced a Phase 1 human proof of concept
study for AQST-305, the Company's sublingual formulation of
octreotide in development for the treatment of acromegaly.
Aquestive's collaborative partnership development activities
continue to advance, and its year-to-date Suboxone volume produced
and shipped has risen by 5%. In addition, AQST-119, an oral soluble
film formulation of tadalafil, a vasodilator that is used to treat
erectile dysfunction, or ED, has its Prescription Drug User Fee Act
(PDUFA) date on November 18, 2018 for
tentative approval.
Third Quarter 2018 Financials
As of September 30, 2018, Aquestive's cash and cash
equivalents were $64.0 million, as
compared to $17.4 million as of
December 31, 2017. In July 2018, Aquestive received net proceeds from
its IPO of $63.5 million.
Aquestive's comprehensive net loss for the third quarter 2018
was $15.0 million, or $0.64 loss per share. The comprehensive net
income for the third quarter 2017 was $7.8
million. The increase in net loss in the third quarter 2018
was driven in part by lower revenue in 2018 compared to 2017 due to
a $14 million reduction in
contractually stipulated collaborative partner license payments.
The loss in the third quarter of 2018 period was also impacted by
increased total expenses compared to 2017, including from selling,
general and administrative expenses that were primarily driven by
investments in SYMPAZAN commercialization.
Investment Community Conference Call
Aquestive will
host an investment community conference call at 4:30 p.m. ET on
Tuesday, November 6, 2018. 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: 3248427. 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 Therapeutics
Aquestive Therapeutics
is a specialty pharmaceutical company focused on identifying,
developing and commercializing differentiated products to address
unmet medical needs. Aquestive Therapeutics has a late-stage
proprietary product pipeline focused on the treatment of CNS
diseases, and is working to advance orally-administered complex
molecules that it believes can be alternatives to
invasively-administered standard of care therapies. As the leader
in developing and delivering drugs via its PharmFilm® technology,
Aquestive Therapeutics also collaborates with pharmaceutical
partners to bring new molecules to market in differentiated and
highly-marketable dosage forms.
Forward-Looking Statement
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as
"anticipate," "believe," "could," "estimate," "expects," "intend,"
"may," "plan," "potential," "project," "will," "would," or the
negative of those terms, and similar expressions, are intended to
identify forward-looking statements. Such statements include, but
are not limited to, statements about regulatory approvals and
pathways, clinical trial timing and plans, the achievement of
clinical and commercial milestones, future financial and operating
results, business strategies, market opportunities, financing, 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; the risks of delays in FDA approval
of our drug candidates or failure to receive approval; the risks
inherent in commercializing a new product (including technology
risks, financial risks, market risks and implementation risks and
regulatory limitations); development of our sales and marketing
capabilities; the rate and degree of market acceptance of our
product candidates; the success of any competing products; the size
and growth of our product markets; the effectiveness and safety of
our product candidates; risks associated with intellectual property
rights and infringement; unexpected patent developments; and other
risks and uncertainties affecting the Company including those
described in the "Risk Factors" section included in our
Registration Statement on Form S-1 declared effective by the SEC on
July 24, 2018 and our other filings
with the Securities and Exchange Commission. As with any
pharmaceutical product candidate under development, there are
significant risks with respect to the development, regulatory
approval and commercialization of new products. 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. We assume no obligation to
update our forward-looking statements after the date of this press
release whether as a result of new information, future events or
otherwise, except as may be required under applicable law.
Media inquiries:
Christopher Hippolyte
christopher.hippolyte@syneoshealth.com
212-364-0458
Investor inquiries:
Stephanie Carrington
stephanie.carrington@icrinc.com
646-277-1282
AQUESTIVE
THERAPEUTICS, INC.
|
Condensed
Consolidated Statements of Operations and Comprehensive
(Loss)/Income
|
(In
thousands, except per share data)
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
|
|
|
|
|
September
30,
|
|
September
30,
|
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
$
13,267
|
|
$
27,146
|
|
$
50,606
|
|
$
54,723
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
Expenses:
|
|
|
|
|
|
|
|
|
|
Manufacture and
supply
|
|
5,592
|
|
4,880
|
|
16,201
|
|
14,205
|
|
Research and
development
|
|
4,534
|
|
5,684
|
|
17,429
|
|
15,862
|
|
Selling,
general and administrative
|
|
12,345
|
|
6,161
|
|
53,561
|
|
17,513
|
|
|
|
Total costs and
expenses
|
|
22,471
|
|
16,725
|
|
87,191
|
|
47,580
|
|
|
|
(Loss)/income
from operations
|
|
(9,204)
|
|
10,421
|
|
(36,585)
|
|
7,143
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expenses):
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(1,933)
|
|
(1,970)
|
|
(5,809)
|
|
(5,737)
|
|
Interest
income
|
|
216
|
|
-
|
|
238
|
|
-
|
|
Change in fair
value of warrant
|
|
(4,116)
|
|
-
|
|
(5,278)
|
|
(309)
|
|
Other,
net
|
|
|
|
(1)
|
|
-
|
|
2
|
|
-
|
|
|
Net
(loss)/income before income taxes
|
|
(15,038)
|
|
8,451
|
|
(47,432)
|
|
1,097
|
|
Income
taxes
|
|
|
-
|
|
-
|
|
-
|
|
-
|
|
|
Net
(loss)/income
|
|
(15,038)
|
|
8,451
|
|
(47,432)
|
|
1,097
|
Dividends on
redeemable preferred interests
|
|
-
|
|
(626)
|
|
-
|
|
(1,854)
|
|
|
Net
(loss)/income attributable to common
|
|
|
|
|
|
|
|
|
|
|
shares/members'
interests
|
|
$
(15,038)
|
|
$
7,825
|
|
$
(47,432)
|
|
$
(757)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
net (loss)/income
|
|
$
(15,038)
|
|
$
7,825
|
|
$
(47,432)
|
|
$
(757)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share - basic and diluted
|
|
$
(0.64)
|
|
|
|
$
(2.45)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common
shares
|
|
|
|
|
|
|
|
|
|
outstanding -
basic and diluted
|
|
23,646,192
|
|
|
|
19,335,541
|
|
|
AQUESTIVE
THERAPEUTICS, INC.
|
Condensed
Consolidated Balance Sheets
|
(In thousands,
except per share / unit amounts)
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
Assets
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
63,982
|
|
$
17,379
|
|
Accounts receivable,
net
|
|
7,450
|
|
6,179
|
|
Inventories,
net
|
|
4,483
|
|
4,014
|
|
Prepaid expenses and
other current assets
|
|
1,444
|
|
591
|
|
|
Total current
assets
|
|
77,359
|
|
28,163
|
Property and
equipment, net
|
|
12,211
|
|
13,460
|
Intangible assets,
net
|
|
216
|
|
254
|
Other
assets
|
|
|
|
224
|
|
1,239
|
|
|
Total
assets
|
|
$
90,010
|
|
$
43,116
|
|
|
|
|
|
Liabilities and
Shareholders' Equity/Members' Deficit
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts payable and
accrued expenses
|
|
$
17,798
|
|
$
14,003
|
|
Deferred
revenue
|
|
781
|
|
1,347
|
|
Loans payable,
current
|
|
2,750
|
|
-
|
|
|
Total current
liabilities
|
|
21,329
|
|
15,350
|
|
Loans payable,
net
|
|
44,054
|
|
45,507
|
|
Warrant
liability
|
|
-
|
|
7,673
|
|
Asset retirement
obligations
|
|
1,183
|
|
1,081
|
|
|
Total
liabilities
|
|
66,566
|
|
69,611
|
|
Commitments and
contingencies (Note 14)
|
|
|
|
|
Redeemable preferred
A-3 interests and accrued dividends
|
|
-
|
|
5,896
|
Redeemable preferred
A-2 interests and accrued dividends
|
|
-
|
|
36,205
|
Shareholders'/Members' deficit:
|
|
|
|
|
|
Preferred A
interests, no par value. Authorized 100,000,000 units;
|
|
|
|
|
|
16,886,750 units issued
and outstanding December 31, 2017
|
|
-
|
|
16,887
|
|
Preferred A-1
interests, no par value. Authorized
|
|
|
|
|
|
100,000,000 units;
21,526,850 units issued and outstanding at December 31,
2017
|
|
-
|
|
21,883
|
|
Common interests, no
par value. Authorized 500,000,000 units;
|
|
|
|
|
|
121,228,353 units
issued and outstanding at December 31, 2017
|
|
-
|
|
12,727
|
|
Common stock, $.001
par value. Authorized 250,000,000 shares;
|
|
|
|
|
|
24,942,185 shares
issued and outstanding at September 30, 2018 (Note 15)
|
|
25
|
|
-
|
|
Additional paid-in
capital
|
|
70,851
|
|
-
|
|
Accumulated
deficit
|
|
(47,432)
|
|
(120,093)
|
|
|
Total shareholders'
equity/members' deficit
|
|
23,444
|
|
(68,596)
|
|
|
Total liabilities and
shareholders' equity/members' deficit
|
|
$
90,010
|
|
$
43,116
|
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SOURCE Aquestive Therapeutics, Inc.