REDWOOD CITY, Calif.,
Aug. 1, 2017 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
moderate-to-severe acute pain, today provided a business update and
reported financial results for the three and six months ended
June 30, 2017.
Clinical Highlights
In the second quarter of 2017, AcelRx presented efficacy and
integrated safety results from the DSUVIA™ (sufentanil sublingual
tablet, 30 mcg) clinical program during the Annual Regional
Anesthesiology and Acute Pain Medicine Meeting. DSUVIA is AcelRx's
lead investigational candidate for the treatment of patients with
moderate-to-severe acute pain in a medically supervised setting. A
New Drug Application (NDA) is currently under review at the U.S.
Food and Drug Administration and a Marketing Authorisation
Application (MAA) for ARX‑04 (known as DSUVIA in the U.S.) is being
evaluated by the European Medicines Agency.
ZALVISO® (sufentanil sublingual tablet system), the
company's patient-controlled analgesia system, was selected for a
Red Dot Award in the category of Product Design – Life Sciences and
Medicine in the second quarter of 2017. The Red Dot Award is
organized by the Design Zentrum Nordrhein Westfalen in Essen, Germany, and is one of the largest
design competitions in the world. ZALVISO is currently marketed in
the EU through the company's licensee, Grunenthal, for the
treatment of moderate to severe post-operative pain management in a
hospital setting.
Today AcelRx reported top-line results from IAP312, a Phase 3
study that treated 320 hospitalized, post-operative patients who
used ZALVISO to self-administer 15 mcg sublingual sufentanil
tablets as often as once every 20 minutes for 24-to-72 hours to
manage their moderate-to-severe acute pain. Throughout the study,
2.2% of patients experienced a ZALVISO device error, which was
statistically less than the 5% limit specified in the study
objectives. In addition, results of this study supported earlier
clinical findings, with favorable tolerability and a significant
majority of "good" or "excellent" ratings provided by both patients
and healthcare providers when assessing the method of pain control.
AcelRx remains on track to resubmit the NDA for ZALVISO by the end
of the year.
"We are making solid progress on our path to commercializing our
two late-stage product candidates, DSUVIA and ZALVISO," stated
Vincent J. Angotti, AcelRx's chief executive officer. "We expect to
receive a decision from the FDA on our marketing application for
DSUVIA in the fourth quarter, and are on track to resubmit the NDA
for ZALVISO to the FDA that same quarter. We also continue to
manage our expenses and cash in line with our plan leading into
these major company milestones."
Second Quarter 2017 Financial Results
Net loss for the second quarter of 2017 was $13.1 million, or $0.29 basic and diluted net loss per share,
compared to $11.1 million, or
$0.24 basic and diluted net loss per
share for the second quarter of 2016. The net loss from operations
in the second quarter of 2017 was $9.9
million, compared to $8.3
million during the second quarter last year.
During the second quarter of 2017, AcelRx recognized revenue of
$2.2 million under the collaboration
agreement with Grunenthal, mainly due to ZALVISO product shipments,
and $0.5 million related to work
performed under the Department of Defense (DoD) contract for
DSUVIA. This compares to $1.3 million
and $3.2 million in revenue
recognized, respectively, from those two agreements in the second
quarter of 2016.
Operating costs and expenses during the second quarter of 2017
included cost of goods sold of $3.5
million related to commercial production of ZALVISO in
support of Grunenthal's European launch, as compared to
$3.0 million during the three months
ended June 30, 2016. Research and
development expenses for the second quarter of 2017 and 2016 were
$4.9 million and $6.3 million, respectively. The net decrease was
due to the completion of the Phase 3 DSUVIA trials in June 2016, partially offset by an increase in
R&D expenses in 2017 related to the IAP312 study for ZALVISO.
General and administrative expenses for the second quarter of 2017
and 2016 were $4.2 million and
$3.6 million, respectively, primarily
due to increased pre-commercialization expenses in 2017. Total
other expense for the second quarter of 2017 was $3.1 million as compared to $2.8 million in the second quarter of 2016, and
consists mainly of non-cash interest expense on the liability
related to the sale of future royalties.
Year-to-Date Financial Results
For the six months ended June 30,
2017, AcelRx reported a net loss of $28.6 million, or $0.63 basic and diluted net loss per share,
compared to $22.1 million, or
$0.49 basic and diluted net loss per
share for the same period in 2016. The increased net loss in the
first half of 2017 is primarily due to decreased DoD contract
revenue, combined with increased costs of goods sold related to
larger shipments of ZALVISO, and higher expenses related to the
IAP312 study and pre-commercialization activities. In addition,
total other expense increased in the six months ended June 30, 2017 primarily due to increased interest
expense on the Hercules loan and other non-cash items, including
interest expense on the liability related to the sale of future
royalties.
During the six months ended June 30,
2017, AcelRx recognized revenue of $5.2 million under the collaboration agreement
with Grunenthal and $0.6 million
related to work performed under the DoD contract for ARX-04. This
compares to $3.1 million and
$4.4 million in revenue,
respectively, related to these agreements in the six months ended
June 30, 2016.
Operating costs and expenses during the six months ended
June 30, 2017 included cost of goods
sold of $7.7 million, as compared to
$6.6 million in the comparable period
last year. Research and development, and general and administrative
expenses during the six months ended June
30, 2017 were $11.8 million
and $8.3 million, respectively. These
compare to $10.5 million in research
and development expenses and $7.4
million in general and administrative expenses in the first
half of last year.
Total other expense of $6.6
million during the six months ended June 30, 2017 compares to $5.2 million in other income during the six
months ended June 30, 2016.
As of June 30, 2017, AcelRx had
cash, cash equivalents and investments of $62.1 million, compared to $80.3 million at December
31, 2016. The decrease was primarily attributable to cash
used in operating activities.
Conference Call
As previously announced, AcelRx will conduct an
investment-community conference call on Tuesday, August 1, 2017 at 8:30 am Eastern Time (5:30
am Pacific Time) to discuss top-line results from the IAP312
study. IAP312 was a Phase 3 study in which hospitalized,
post-operative patients self-administered 15 microgram sublingual
sufentanil tablets using ZALVISO® (sufentanil sublingual tablet
system) as often as once every 20 minutes to manage their
moderate-to-severe acute pain. The company also plans to discuss
its financial results for the three and six months ended
June 30, 2017. Please note, this
conference call and webcast will replace the previously announced
financial results conference call that had been scheduled for
August 2, 2017. A separate press
release regarding the Phase 3 IAP312 study top-line results was
issued today.
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. A New Drug Application (NDA) for 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, was accepted for filing by the
United States Food and Drug Administration (FDA) and has been given
a PDUFA date of October 12, 2017. In
the EU, the European Medicines Agency (EMA) has notified the
company that the ARX-04 (sufentanil sublingual tablet, 30 mcg)
Marketing Authorisation Application (MAA) has passed validation and
that the scientific review of the MAA is underway.
The company's product candidate, ZALVISO® (sufentanil
sublingual tablet system), is designed for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting. The company recently completed a Phase 3 clinical trial,
IAP312, which included input from the FDA on the study protocol.
This study was designed to evaluate the effectiveness of changes
made to the functionality and usability of the ZALVISO device, to
evaluate the incidence of inadvertent dosing, and to take into
account comments from the FDA on the study protocol. AcelRx intends
to resubmit the NDA for ZALVISO to the FDA by the end of the year.
ZALVISO delivers 15 mcg sufentanil sublingually through a
non-invasive delivery route via a pre-programmed,
patient-controlled analgesia device. ZALVISO is approved in the EU
and is investigational and in late-stage development in
the United States. Grunenthal
Group holds the rights for ZALVISO in Europe, where a commercialization across
multiple countries is underway.
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; the
potential approval of the DSUVIA NDA by the FDA; the European
Medicines Agency (EMA) scientific review of the ARX-04 Marketing
Authorisation Application (MAA); the DSUVIA and ARX-04 clinical
trial results; AcelRx's pathway forward towards gaining approval of
ZALVISO in the United States,
including the planned resubmission and timing of the ZALVISO NDA to
the FDA; and the therapeutic and commercial potential of AcelRx's
product candidates, including potential market opportunities for
DSUVIA, ARX-04 and ZALVISO. 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
the FDA review of the DSUVIA NDA, the EMA review of the ARX-04 MAA,
and the possibility that the FDA or EMA may dispute or interpret
differently clinical results obtained from the DSUVIA or 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 May 8, 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
|
|
Six Months
Ended
|
|
June
30
|
|
June
30
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Collaboration
agreement revenue
|
$
2,192
|
|
$
1,314
|
|
$
5,219
|
|
$
3,107
|
Contract and other
revenue
|
467
|
|
3,217
|
|
549
|
|
4,449
|
Total
revenue
|
2,659
|
|
4,531
|
|
5,768
|
|
7,556
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
3,543
|
|
2,976
|
|
7,668
|
|
6,575
|
Research and
development (1)
|
4,901
|
|
6,280
|
|
11,820
|
|
10,451
|
General and
administrative (1)
|
4,156
|
|
3,597
|
|
8,294
|
|
7,374
|
Total operating costs
and expenses
|
12,600
|
|
12,853
|
|
27,782
|
|
24,400
|
Loss from
operations
|
(9,941)
|
|
(8,322)
|
|
(22,014)
|
|
(16,844)
|
|
|
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
|
|
|
Interest
expense
|
(903)
|
|
(687)
|
|
(1,677)
|
|
(1,367)
|
Interest income and
other income (expense), net(2)
|
396
|
|
241
|
|
250
|
|
660
|
Non-cash interest
expense on liability related to sale of future royalties
|
(2,609)
|
|
(2,324)
|
|
(5,167)
|
|
(4,520)
|
Total other
expense
|
(3,116)
|
|
(2,770)
|
|
(6,594)
|
|
(5,227)
|
Provision for income
taxes
|
(2)
|
|
-
|
|
(2)
|
|
(2)
|
Net loss
|
$
(13,059)
|
|
$
(11,092)
|
|
$(28,610)
|
|
$(22,073)
|
|
|
|
|
|
|
|
|
Basic net loss per
common share
|
$
(0.29)
|
|
$
(0.24)
|
|
$
(0.63)
|
|
$
(0.49)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net loss per common share
|
45,379
|
|
45,312
|
|
45,364
|
|
45,300
|
|
|
|
|
|
|
|
|
Diluted net loss per
common share
|
$
(0.29)
|
|
$
(0.24)
|
|
$
(0.63)
|
|
$
(0.49)
|
|
|
|
|
|
|
|
|
Shares used in
computing diluted net loss per common share
|
45,379
|
|
45,312
|
|
45,364
|
|
45,300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
79
|
|
$
77
|
|
$
163
|
|
$
148
|
Research and development
|
448
|
|
586
|
|
985
|
|
1,186
|
General and administrative
|
551
|
|
482
|
|
1,074
|
|
996
|
Total
|
$
1,078
|
|
$
1,145
|
|
$
2,222
|
|
$
2,330
|
|
|
|
|
|
|
|
|
(2) Interest
income and other income (expense) includes $0.3 million and $0.2
million in non-cash income for the three months ended June 30, 2017
and 2016, respectively, and $0.3 million and $0.5 million in
non-cash income for the six months ended June 30, 2017 and 2016,
respectively, related to warrants issued in connection with a
private placement equity financing, completed in June
2012.
|
|
|
|
|
|
|
|
|
|
June 30,
2017
|
|
December 31,
2016
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
62,148
|
|
$
80,310
|
|
|
|
|
Total
assets
|
66,769
|
|
99,993
|
|
|
|
|
Total
liabilities
|
109,814
|
|
105,330
|
|
|
|
|
Total stockholders'
deficit
|
(31,624)
|
|
(5,337)
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE AcelRx Pharmaceuticals, Inc.