REDWOOD CITY, Calif.,
Nov. 9, 2017 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty
pharmaceutical company today reported third quarter 2017 financial
results.
"In response to the DSUVIA CRL, we are pleased to have compiled
and submitted the Briefing Book and request for a Type A meeting
with the FDA. Our goal is to have this meeting scheduled before the
end of the year to provide clarity on our path towards DSUVIA NDA
resubmission," stated Vince Angotti,
AcelRx's chief executive officer. "DSUVIA remains our core asset as
we believe the recommendations in the CRL are manageable. In
addition, we successfully completed the ZALVISO Phase 3 study
requested by the FDA, and remain focused on providing physicians
and patients with non-invasive pain management options for
moderate-to-severe acute pain within medically supervised settings.
We also reduced our cash spending during the quarter, and plan to
continue our prudent cash management in the coming quarters to
maintain our solid liquidity position."
Recent Highlights
- Reported successful outcome of ZALVISO Phase 3 IAP312 study on
device functionality, achieving the study objective with 2.2% of
patients experiencing a device error, which was statistically less
than the 5% limit specified in the study objective.
- On track for the resubmission of the NDA for ZALVISO by the end
of the year with the intention to resubmit after the DSUVIA Type A
meeting.
- Received a CRL in October 2017
from the FDA regarding its NDA for DSUVIA. A Type A meeting request
was submitted to the FDA to discuss the topics covered in the CRL
and to confirm plans to move towards resubmission of the DSUVIA
NDA.
Third Quarter 2017 Financial Information
- September 30, 2017 cash balance
of $67.9 million.
- Revenue of $1.5 million,
consisting of $1.2 million related to
the collaboration with Grunenthal, and $0.3
million related to work performed under the Department of
Defense (DoD) contract for DSUVIA. The $1.9
million decline from the third quarter of 2016 is mainly
attributed to lower invoicing under our DoD contract due to less
DSUVIA development work in the quarter.
- Cost of goods sold of $2.0
million related to commercial production of ZALVISO in
support of Grunenthal's European launch, as compared to
$2.6 million during the third quarter
of 2016.
- R&D and G&A expenses totaled $8.3 million, and excluding stock-based
compensation was $7.4 million,
declining $0.4 million compared to
the third quarter of 2016. The decrease was mainly due to the
completion of the Phase 3 DSUVIA trials in 2016, and lower
ZALVISO-related development costs offset by an increase in
DSUVIA-related pre-commercialization expenses.
- Net loss for the third quarter of 2017 was $13.0 million, or $0.28 basic and diluted net loss per share,
compared to $11.4 million, or
$0.25 basic and diluted net loss per
share for the third quarter of 2016. The net loss from operations
in the third quarter of 2017 was $8.9
million, compared to $8.0
million during the third quarter last year.
Year-to-Date Financial Information
- For the nine months ended September 30,
2017, revenue of $7.2 million,
consisting of $6.4 million under the
collaboration agreement with Grunenthal, and $0.8 million related to work performed under the
Department of Defense contract for DSUVIA. This compares to revenue
related to those two agreements of $4.7
million and $6.2 million,
respectively, for the nine months ended September 30, 2016. Higher ZALVISO product sales
to Grunenthal were offset by the timing of DSUVIA development work
reimbursed under our contract with the DoD.
- Cost of goods sold of $9.7
million related to the production of ZALVISO for
Grunenthal's European launch, as compared to $9.2 million in the comparable period last
year.
- R&D and G&A expenses totaled $28.4 million, and excluding stock-based
compensation was $25.4 million, in
the nine months ended September 30,
2017, compared to $26.6
million, and excluding stock-based compensation was
$23.4 million, during the nine months
ended September 30, 2016. The
increase was primarily due to the IAP312 clinical trial for ZALVISO
and DSUVIA-related pre-commercialization expenses.
- Net loss of $41.6 million, or
$0.91 basic and diluted net loss per
share, compared to $33.5 million, or
$0.74 basic and diluted net loss per
share for the same period in 2016.
Conference Call
As previously announced, AcelRx will
conduct an investment-community conference call on Thursday, November 9, 2017 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these
financial results. Investors who wish to participate in the
conference call may do so by dialing (866) 361-2335 for domestic
callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for
international callers. Those interested in listening to a webcast
of the conference call live via the Internet may do so by visiting
the Investors page of the company's website at www.acelrx.com and
clicking on the webcast link on the Investors home page. The
webcast will be archived on the AcelRx website for 90 days
following the call.
About AcelRx Pharmaceuticals, Inc.
AcelRx
Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on the development and commercialization of innovative therapies
for the treatment of moderate-to-severe acute pain. AcelRx's
proprietary, non-invasive sublingual formulation technology
delivers sufentanil with consistent pharmacokinetic profiles. The
company has two product candidates including DSUVIA™
(sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside
the United States, with a proposed
indication for the treatment of moderate-to-severe acute pain in
medically supervised settings, and ZALVISO® (sufentanil
sublingual tablet system, SST system, 15 microgram) being developed
as an innovatively designed patient-controlled analgesia (PCA)
system for reduction of moderate-to-severe acute pain in medically
supervised settings.
For additional information about AcelRx's clinical programs,
please visit www.acelrx.com.
Forward-Looking Statements
This press release
contains forward-looking statements, including, but not limited to,
statements related to the process and timing of anticipated future
development of AcelRx's product candidates, DSUVIA™
(sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside
the United States, and
ZALVISO® (sufentanil sublingual tablet system),
including U.S. Food and Drug Administration, or FDA, review of the
New Drug Application, or NDA, for DSUVIA; evaluation of the CRL and
AcelRx's plans for resubmission of the NDA for DSUVIA with the FDA;
the timing of the planned resubmission of the ZALVISO NDA; and the
Company's ability to continue its cash management plan and maintain
a solid liquidity position. These forward-looking statements are
based on AcelRx Pharmaceuticals' current expectations and
inherently involve significant risks and uncertainties. AcelRx
Pharmaceuticals' actual results and timing of events could differ
materially from those anticipated in such forward-looking
statements, and as a result of these risks and uncertainties, which
include, without limitation, risks related to AcelRx
Pharmaceuticals' DSUVIA and ARX-04 development programs, including
EMA review of the ARX-04 MAA, and the possibility that EMA may
dispute or interpret differently clinical results obtained from the
ARX-04 Phase 2 and 3 studies; the possibility that the FDA may
dispute or interpret differently the results of the ZALVISO
development program, including the results from the IAP312 clinical
trial; the resubmission of the ZALVISO NDA to the FDA; any delays
or inability to obtain and maintain regulatory approval of its
product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical
development process, including adverse events; the success, cost
and timing of all development activities and clinical trials; the
accuracy of AcelRx's estimates regarding expenses, capital
requirements and the need for financing; and other risks detailed
in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and
Exchange Commission filings and reports, including its Quarterly
Report on Form 10-Q filed with the SEC on August 2, 2017. AcelRx undertakes no duty or
obligation to update any forward-looking statements contained in
this release as a result of new information, future events or
changes in its expectations.
Selected Financial
Data
|
(in thousands, except
per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30
|
|
September
30
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Collaboration
agreement revenue
|
$
1,225
|
|
$
1,562
|
|
$
6,444
|
|
$
4,669
|
Contract and other
revenue
|
262
|
|
1,804
|
|
811
|
|
6,253
|
Total
revenue
|
1,487
|
|
3,366
|
|
7,255
|
|
10,922
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
2,029
|
|
2,579
|
|
9,697
|
|
9,154
|
Research and
development (1)
|
3,913
|
|
4,617
|
|
15,733
|
|
15,068
|
General and
administrative (1)
|
4,406
|
|
4,145
|
|
12,700
|
|
11,519
|
Total operating costs
and expenses
|
10,348
|
|
11,341
|
|
38,130
|
|
35,741
|
Loss from
operations
|
(8,861)
|
|
(7,975)
|
|
(30,875)
|
|
(24,819)
|
|
|
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
|
|
|
Interest
expense
|
(919)
|
|
(702)
|
|
(2,596)
|
|
(2,069)
|
Interest income and
other income (expense), net(2)
|
(465)
|
|
(360)
|
|
(215)
|
|
300
|
Non-cash interest
expense on liability related to sale of future royalties
|
(2,768)
|
|
(2,401)
|
|
(7,935)
|
|
(6,921)
|
Total other
expense
|
(4,152)
|
|
(3,463)
|
|
(10,746)
|
|
(8,690)
|
Benefit (provision)
for income taxes
|
-
|
|
36
|
|
(2)
|
|
34
|
Net loss
|
$(13,013)
|
|
$(11,402)
|
|
$(41,623)
|
|
$(33,475)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.28)
|
|
$
(0.25)
|
|
$
(0.91)
|
|
$
(0.74)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
46,365
|
|
45,319
|
|
45,701
|
|
45,306
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
80
|
|
$
77
|
|
$
243
|
|
$
225
|
Research and development
|
458
|
|
560
|
|
1,442
|
|
1,746
|
General and administrative
|
480
|
|
441
|
|
1,555
|
|
1,437
|
Total
|
$
1,018
|
|
$
1,078
|
|
$
3,240
|
|
$
3,408
|
|
|
|
|
|
|
|
|
(2) Interest
income and other income (expense) includes $0.6 million and $0.4
million in non-cash charges for the three months ended September
30, 2017 and 2016, respectively, and $0.4 million in non-cash
charges and $0.1 million in non-cash income for the nine months
ended September 30, 2017 and 2016, respectively, related to
warrants issued in connection with a private placement equity
financing, completed in June 2012.
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
December 31,
2016
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
67,936
|
|
$
80,310
|
|
|
|
|
Total
assets
|
82,743
|
|
99,993
|
|
|
|
|
Total
liabilities
|
113,052
|
|
105,330
|
|
|
|
|
Total stockholders'
deficit
|
(30,309)
|
|
(5,337)
|
|
|
|
|
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SOURCE AcelRx Pharmaceuticals, Inc.