REDWOOD CITY, Calif.,
March 2, 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
acute pain, today provided a business update and reported financial
results for the fourth quarter and full year ended
December 31, 2016.
Corporate and Clinical Highlights
During the fourth
quarter of 2016, AcelRx submitted a New Drug Application (NDA)
under section 505(b)(2) with the U.S. Food and Drug Administration
(FDA) for DSUVIA™ (sufentanil sublingual tablet, 30 mcg)
for the treatment of patients experiencing moderate-to-severe acute
pain in a medically supervised setting. Recently, this application
was accepted for filing, and a Prescription Drug User Fee Act
(PDUFA) goal date of October 12, 2017
was assigned.
During the fourth quarter, AcelRx updated its expectations of
DSUVIA's market potential, and presented these findings at an
analyst and investor event in December. Should DSUVIA be approved
in the U.S. and then subsequently in Europe, the company's expectations, based on
commissioned research, are for an estimated $1.1 billion in peak sales in the U.S. and €700
million in Europe.
"We have taken meaningful steps towards meeting our goal of
DSUVIA approval in the U.S., and we continue to make additional
commercial preparations for a potential DSUVIA launch," commented
Howie Rosen, chief executive
officer. Mr. Rosen continued. "A key aspect of our preparations, as
we announced a few weeks ago, is having appointed Vincent J. Angotti to be chief executive officer
starting March 6th. Vince
has over 25 years of successful commercial experience, most
recently at Xenoport, where he managed the relaunch of Horizant as
COO, and as CEO led their acquisition by Arbor Pharmaceuticals. I
look forward to working with Vince and the AcelRx team in my
continuing role on the Board of Directors."
In the fourth quarter of 2016, AcelRx also made a number of
presentations of DSUVIA results from the Phase 3 clinical program.
These included the first presentation of complete results from the
Phase 3 SAP303 study, which was conducted in 140 patients aged
≥40 years who had undergone short-stay, in-patient or out-patient
surgery. These results, which were presented at the Annual Pain
Medicine Meeting of the American Society of Regional Anesthesia and
Pain Medicine (ASRA), showed that patients administered DSUVIA
experienced a 49% reduction (p < 0.001) in mean pain intensity
from baseline during the first 2 hours, and maintained that
reduction for the duration of the 12-hour study period. The most
common study drug-related adverse events in the study population
were nausea (27%) and dizziness (4%).
Corporate Milestones for DSUVIA and ARX-04 in the
Upcoming Year:
- Submit the European Regulatory Application. AcelRx
expects to submit a Marketing Authorization Application (MAA) under
the Centralized Procedure for ARX-04 with the European Medicines
Agency (EMA) in the first half of 2017.
- Plan for Potential U.S. Approval and Commercialization.
In anticipation of the potential for NDA approval by the PDUFA
date, AcelRx continues its preparation for commercialization of
DSUVIA.
Fourth Quarter 2016 Financial Results
Net loss for the
fourth quarter of 2016 was $9.7
million, or $0.21 basic and
diluted net loss per share, compared to a net loss of $10.5 million, or $0.24 basic and diluted net loss per share for
the fourth quarter of 2015. The decrease in net loss in the fourth
quarter 2016, as compared to the fourth quarter 2015, was primarily
due to an increase in revenue partially offset by increased
operating costs and expenses.
During the fourth quarter of 2016, AcelRx recognized revenue of
$1.8 million under the collaboration
agreement with Grunenthal and $4.6
million related to work performed under the DoD contract for
DSUVIA. This compares to $0.3 million
in revenue recognized under the collaboration agreement with
Grunenthal and $1.4 million in
revenue recognized related to the DoD contract during the fourth
quarter of 2015.
Operating costs and expenses during the fourth quarter of 2016
included cost of goods sold of $3.2
million, as compared to $1.8
million for the fourth quarter 2015. Research and
development expenses for the fourth quarter of 2016 were
$6.3 million, as compared to
$3.5 million for the fourth quarter
of 2015. The $2.8 million increase in
R&D expenses was primarily due to increased DSUVIA-related
expenses, including the filing fee for the DSUVIA NDA. General and
administrative expenses were $4.1
million during the fourth quarter of 2016, as compared to
$4.0 million for the fourth quarter
of 2015.
Total other expense decreased from $3.0
million in the fourth quarter of 2015 to $2.5 million in the fourth quarter of 2016,
primarily due to the change in the fair value of our warrants, or
PIPE warrants, issued in connection with the private placement of
our common stock, which was completed in June 2012.
Full-Year 2016 Financial Results
For the year-ended
December 31, 2016, AcelRx reported a
net loss of $43.2 million, or
$0.95 basic and diluted net loss per
share, as compared to a net loss of $24.4
million, or $0.55 basic net
loss per share and $0.60 diluted net
loss per share for the same period in 2015. Common shares used in
calculating earnings per share were 45.3 million for basic and
diluted net loss in 2016, as compared to 44.3 million for basic EPS
and 44.5 million for diluted EPS in 2015.
AcelRx recognized revenue of $6.4
million under the collaboration agreement with Grunenthal
and $10.9 million related to work
performed under the DoD contract for DSUVIA in 2016. This compares
to $14.9 million in revenue
recognized under the collaboration agreement with Grunenthal and
$4.4 million in revenue related to
the DoD contract recognized in 2015. AcelRx began shipments of
commercial product to Grunenthal in the second quarter of 2016. In
2015, upon approval of the MAA for ZALVISO, the Company recognized
revenue related to a milestone payment received from Grunenthal
under the collaboration agreement.
Operating costs and expenses during 2016 included cost of goods
sold of $12.3 million, as compared to
$1.8 million during the year ended
December 31, 2015. Research and
development, and general and administrative expenses during the
year were $21.4 million and
$15.6 million, respectively. These
compare to $22.5 million in research
and development expenses and $14.2
million in general and administrative expenses last year.
The $1.1 million decrease in R&D
expenses was primarily attributable to a $3.1 million reduction in overhead costs,
predominantly as a result of the allocation of certain research and
development personnel and related expenses to cost of goods sold, a
$0.9 million decrease in
ZALVISO-related expenses due to the completion of certain
development activities as AcelRx finalized the development path
forward with the FDA, partially offset by an incremental increase
of $2.9 million in DSUVIA-related
spending as the DSUVIA development program reached completion and
the NDA was prepared and submitted to the FDA. The $1.4 million increase in general and
administrative expenses in 2016 was primarily due to $2.4 million in increased DSUVIA-related market
research activities, and $0.3 million
in ZALVISO-related market research activities, offset by decreases
of $0.6 million in professional
services and legal expenses, $0.5
million in stock-based compensation expense, and a net
decrease of $0.2 million in other
general and administrative-related expenses.
Total other expense was $11.2
million during 2016, as compared to $3.7 million during 2015. The difference was
primarily a result of the non-cash interest expense related to the
monetization of the expected royalty stream, or Royalty
Monetization, from the sales of ZALVISO in the EU by Grunenthal to
PDL BioPharma, Inc.
The Royalty Monetization resulted in a taxable gain of more than
$60.0 million in the year ended
December 31, 2015, the majority of
which was offset with net operating loss carryforwards; however,
AcelRx was subject to U.S. federal alternative minimum taxes in
2015, as reflected in its provision for income taxes in 2015.
As of December 31, 2016, AcelRx
had cash, cash equivalents and investments of $80.3 million, compared to $113.5 million at December
31, 2015. The decrease was primarily attributable to cash
used in operating activities.
Conference Call
AcelRx will conduct a conference call
and webcast today, March 2, 2017 at
4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss these
financial results and business updates. To listen to the conference
call, dial in approximately ten minutes before the scheduled call
1-866-361-2335 for domestic callers, 1-855-669-9657 for Canadian
callers, or 1-412-902-4204 for international callers. Those
interested in listening to the conference call live via the
Internet may do so by visiting the Investors section of the
company's website at www.acelrx.com. A webcast replay will be
available on the AcelRx website for 90 days following the call by
visiting the Investors section of the company's website at
www.acelrx.com.
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. An NDA for
DSUVIA (sufentanil sublingual tablet, 30mcg) with a proposed
indication for the treatment of moderate-to-severe acute pain in
medically supervised settings, was accepted for filing by the FDA
with a Prescription Drug User Fee Act (PDUFA) goal date of
October 12, 2017.
The Company's follow on product candidate, ZALVISO®
(sufentanil sublingual tablet system), designed for the management
of moderate-to-severe acute pain in adult patients in the hospital
setting, is currently enrolling patients in a Phase 3 clinical
trial, IAP312. 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 U.S.
Grunenthal Group holds the rights for ZALVISO in Europe, where a commercial launch has
begun.
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, DSUVIATM
(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 DSUVIA and ARX-04 clinical trial
results; AcelRx's pathway forward towards gaining approval of
ZALVISO in the U.S., including successful completion of the IAP312
clinical study for ZALVISO; the therapeutic and commercial
potential of AcelRx's product candidates, including potential
market opportunities for DSUVIA, ARX-04 and ZALVISO and
anticipated cash balance at year-end 2017. 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 and the possibility that
the FDA may dispute or interpret differently clinical results
obtained from the DSUVIA Phase 3 studies; the ZALVISO development
program, including successful completion of IAP312 and 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; the success, cost and timing of all
development activities and clinical trials; 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
November 2, 2016. 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
|
|
Twelve
Months Ended
|
|
December
31
|
|
December
31
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
agreement revenue
|
$
1,771
|
|
$
327
|
|
$
6,440
|
|
$
14,857
|
Contract and other
revenue
|
4,664
|
|
1,403
|
|
10,917
|
|
4,406
|
Total
revenue
|
6,435
|
|
1,730
|
|
17,357
|
|
19,263
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
(1)
|
3,161
|
|
1,770
|
|
12,315
|
|
1,770
|
Research and
development (1)
|
6,334
|
|
3,479
|
|
21,402
|
|
22,488
|
General and
administrative (1)
|
4,078
|
|
4,017
|
|
15,597
|
|
14,203
|
Restructuring
costs
|
-
|
|
-
|
|
-
|
|
756
|
Total operating costs
and expenses
|
13,573
|
|
9,266
|
|
49,314
|
|
39,217
|
Loss from
operations
|
(7,138)
|
|
(7,536)
|
|
(31,957)
|
|
(19,954)
|
|
|
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
|
|
|
Interest
expense
|
(701)
|
|
(681)
|
|
(2,770)
|
|
(2,977)
|
Interest income and
other income(2)
|
618
|
|
(195)
|
|
918
|
|
1,720
|
Non-cash interest
expense on liability related to sale of future royalties to
PDL
|
(2,461)
|
|
(2,146)
|
|
(9,382)
|
|
(2,428)
|
Total other
expense
|
(2,544)
|
|
(3,022)
|
|
(11,234)
|
|
(3,685)
|
Benefit (provision)
for income taxes
|
-
|
|
12
|
|
34
|
|
(760)
|
Net loss
|
$
(9,682)
|
|
$
(10,546)
|
|
$(43,157)
|
|
$(24,399)
|
|
|
|
|
|
|
|
|
Basic net loss per
common share
|
$
(0.21)
|
|
$
(0.24)
|
|
$
(0.95)
|
|
$
(0.55)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net loss per common share
|
45,334
|
|
44,568
|
|
45,313
|
|
44,300
|
|
|
|
|
|
|
|
|
Diluted net loss per
common share
|
$
(0.21)
|
|
$
(0.24)
|
|
$
(0.95)
|
|
$
(0.60)
|
|
|
|
|
|
|
|
|
Shares used in
computing diluted net loss per common share
|
45,334
|
|
44,568
|
|
45,313
|
|
44,468
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
$
77
|
|
$
67
|
|
$
302
|
|
$
67
|
Research and development
|
562
|
|
620
|
|
2,308
|
|
2,587
|
General and administrative
|
432
|
|
503
|
|
1,869
|
|
2,356
|
Total
|
$
1,071
|
|
$
1,190
|
|
$
4,479
|
|
$
5,010
|
|
|
|
|
|
|
|
|
(2) Interest
income and other income (expense) includes $0.5 million in non-cash
income for the three months ended December 31, 2016 and $0.6
million in non-cash income for the twelve months ended December 31,
2016, as compared to $0.3 million in non-cash charges for the three
months ended December 31, 2015 and $2.1 million in non-cash income
for the twelve months ended December 31, 2015, respectively,
related to warrants issued in connection with a private placement
equity financing, completed in June 2012.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2016
|
|
December 31,
2015
|
Selected Balance
Sheet Data
|
|
|
|
Cash, cash
equivalents and investments
|
$
80,310
|
|
$
113,464
|
Total
assets
|
99,993
|
|
127,785
|
Total
liabilities
|
105,330
|
|
94,672
|
Total stockholders'
(deficit) equity
|
(5,337)
|
|
33,113
|
|
|
|
|
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SOURCE AcelRx Pharmaceuticals, Inc.