REDWOOD CITY, Calif.,
Nov. 5, 2013 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute and breakthrough pain, today reported financial results for
the three and nine months ended September
30, 2013.
"With the submission of our NDA at the end of September for
Zalviso™, AcelRx has commenced activities related to an anticipated
U.S. commercial launch," stated Richard
King, president and CEO of AcelRx. "We also continue
to actively participate in key medical meetings worldwide to
increase awareness of the results from our completed Zalviso Phase
3 clinical trials among a broad audience of medical professionals
involved in pain treatment. Having appointed our Chief
Commercial Officer last quarter, we are working diligently to
prepare Zalviso to be well positioned for launch in the US market,
subject to regulatory approval."
Third Quarter and Nine Months Financial Results
Net loss for the third quarter of 2013 was $11.0 million, or $0.26 per share, compared with a net loss of
$8.6 million, or $0.38 per share for the third quarter of 2012.
The adjusted net loss for the third quarter of 2013 was
$8.6 million, or $0.21 per share and excludes a $2.4 million non-cash expense resulting from the
liability accounting related to warrants issued in connection with
the PIPE financing completed in June
2012. There was no such expense recorded in the third
quarter of 2012.
During the third quarters of 2013 and 2012, AcelRx recognized
revenue of $0.5 million and
$0.2 million, respectively, as
reimbursement for work completed under a research grant from the
U.S. Army Medical Research and Materiel Command, or USAMRMC, for
development of ARX-04, a sufentanil NanoTab product candidate for
the treatment of moderate-to-severe acute pain in a range of
military and ambulatory environments.
Research and development, or R&D, expenses for the quarter
ended September 30, 2013 totaled
$6.5 million, compared with
$6.9 million for the quarter ended
September 30, 2012. R&D
expense for the third quarter of 2013 included a fee of
approximately $1.95 million for
submission of the NDA for Zalviso. Excluding the NDA
submission fee, the third quarter R&D expenses reflect lower
clinical costs when compared to second quarter 2013 as a result of
the completion of the Phase 3 development program for Zalviso in
the second quarter of 2013.
General and administrative expenses were $2.3 million for the third quarter of 2013,
compared with $1.4 million for the
third quarter of 2012, due primarily to an increase in Zalviso
commercial preparation activities.
Other income and expense includes a $2.4
million non-cash charge in the third quarter of 2013
resulting from the liability accounting related to the warrants
issued in connection with the PIPE financing completed in June
2012. The primary determinant of this charge was an increase
in share price during the third quarter of 2013 and its resulting
impact on the Black-Scholes valuation of these warrants.
For the nine months ended September 30,
2013, AcelRx reported a net loss of $41.2 million, or $1.07 per share, compared with a net loss of
$22.8 million, or $1.09 per share for the same period in 2012.
Adjusted net loss for the nine months ended September 30, 2013 was $27.8 million, or $0.72 per share. Adjusted net loss excludes
the $13.4 million non-cash expense
resulting from the liability accounting related to the warrants
issued in connection with the PIPE financing completed in
June 2012.
R&D expenses for the nine months ended September 30, 2013 totaled $22.0 million, compared with $17.1 million for the nine months ended
September 30, 2012. The
increase was primarily due to expenses associated with the Phase 3
clinical studies of Zalviso and the NDA filing fee. General
and administrative expenses were $6.6
million for the nine months of 2013, compared with
$5.3 million for the nine months
ended September 30, 2012 due
primarily to an increase in stock based compensation and commercial
preparation activities.
As of September 30, 2013, AcelRx
had cash, cash equivalents and investments of $76.0 million, compared to $59.8 million at December
31, 2012 and $36.8 million at
June 30, 2013. In July 2013, AcelRx raised $47.9 million in net proceeds through the
issuance of 4.37 million shares of common stock in an underwritten
public offering. Net cash used in the third quarter of 2013,
excluding the offering proceeds, was $8.7
million.
Review of Recent Accomplishments and Corporate Update
- On September 27, 2013, AcelRx
submitted an NDA to the FDA for Zalviso for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting. The NDA submission is based primarily on data from a Phase
3 registration program that included two double-blind, randomized,
placebo-controlled clinical trials, one in patients following open
abdominal surgery and the other in patients following hip or knee
replacement surgery. An additional open label active comparator
trial was conducted in patients following major abdominal or
orthopedic surgery that compared Zalviso to intravenous patient
controlled analgesia, or IV PCA, with morphine.
- In July 2013, AcelRx completed an
underwritten public offering of 4,370,000 shares of common stock,
including 570,000 shares which were issued pursuant to the exercise
of the underwriters' option to purchase additional shares, at a
price of $11.65 per share. The total
net proceeds of this offering were $47.9
million after deducting underwriting discounts and
commissions and other expenses payable by AcelRx. AcelRx intends to
use the net proceeds from this offering to fund potential
regulatory approval of Zalviso both in the U.S. and Europe, the continuing preparation for and the
potential commercial launch of Zalviso in the U.S., and for working
capital and other general corporate purposes.
- In September 2013, David H. Chung joined AcelRx as chief commercial
officer with responsibility for establishing, developing and
leading the company's commercial operations. Mr. Chung has over 20
years of hospital-focused, global medical device and pharmaceutical
marketing experience, most recently as chief commercial officer at
Conceptus, Inc.
- The expanding patent portfolio for AcelRx now totals 9 issued
U.S. patents and 19 issued patents worldwide. These issued patents
cover AcelRx's sufentanil NanoTab, medication delivery devices and
platform technology, and are expected to provide coverage through
2027 – 2031.
- In October, 2013, data from the Phase 3 clinical trial
evaluating Zalviso in the treatment of post-operative pain in
patients following either knee or hip replacement surgery compared
to placebo, was presented at two major medical meetings. The
presentations occurred during the European Federation of IASP
Chapters Annual Congress in Florence,
Italy and at the American Society of Anesthesiologists
meeting in San Francisco. Results
demonstrated that patients receiving Zalviso realized a
significantly greater Summed Pain Intensity Difference to baseline
for 48 hours (SPID-48), the FDA-requested primary endpoint, during
the study period than placebo-treated patients (+76.1 vs. -11.5,
p<0.001). Adverse events reported in the study were generally
mild or moderate in nature and were similar in both placebo and
treatment groups for the majority of adverse events. Additional
posters presented at both of these meetings highlighted more
detailed results from the Phase 3 placebo-controlled study
conducted in abdominal surgery patients, the Phase 3
active-comparator study comparing Zalviso to IV PCA with morphine,
and pharmacokinetic data from a study describing different routes
of sufentanil delivery (IV vs. transmucosal vs.
oral/swallowed).
Financial Outlook
AcelRx records as revenue the reimbursement received pursuant to
the $5.6 million USAMRMC grant
received in 2011. To date, revenue from this grant has been the
only source of revenue recognized by AcelRx resulting in recorded
revenues of $5.4 million through
September 30, 2013. We expect
the remaining $0.2 million to be
recorded as revenue in the fourth quarter of 2013.
We anticipate that quarterly R&D expenses through the end of
2013 will continue to decline due to lower clinical development
costs associated with the Zalviso and ARX-04 programs.
Additionally, we anticipate higher general and administrative
expense in the fourth quarter of 2013 due to an increase in Zalviso
U.S. commercial preparations and the expansion of its corporate
infrastructure to support an emerging commercial
organization.
Total operating expenses for 2013 are anticipated to be modestly
higher than they were in 2012.
Other income and expense in future periods is expected to
include non-cash charges that result from the liability accounting
related to the warrants AcelRx issued in connection with the PIPE
financing completed in the second quarter of 2012. The
primary determinant of this charge is stock price change over each
quarter and its impact on the Black-Scholes valuation of these
warrants. For this reason, the impact in future periods is very
difficult to predict and is not included in the company's
guidance.
AcelRx believes its current cash, cash equivalents and
investments including funding from the public equity offering in
July 2013, are sufficient to fund
operations at least through the end of 2014. We expect the
use of cash will decrease during the fourth quarter of 2013
compared to the first three quarters of the year as expenditures,
primarily R&D expenses, decline for clinical activity and final
payments are made to contract research organizations.
Conference Call
AcelRx will conduct a conference call and webcast today,
November 5, 2013 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss its financial
results and program updates. To listen to the conference call, dial
in approximately ten minutes before the scheduled call to (877)
870-4263 for domestic callers, (855) 669-9657 for Canadian callers,
or (412) 317-0790 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 and selecting the webcast link for the Q3 2013
earnings conference call. 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 acute and breakthrough
pain. AcelRx's lead product candidate, Zalviso™, is designed
to solve the problems associated with post-operative intravenous
patient-controlled analgesia which has been shown to cause harm to
patients following surgery because of the side effects of morphine,
the invasive IV route of delivery and the complexity of infusion
pumps. AcelRx has announced positive results from each of the
three completed Phase 3 clinical trials for Zalviso, and has
submitted an NDA to the FDA seeking approval for Zalviso to be used
to treat moderate-to-severe acute pain in the hospital
setting. AcelRx has also announced positive top-line results
for a Phase 2 trial for ARX-04, a product candidate for the
treatment of moderate-to-severe acute pain in a medically
supervised setting, funded through a grant from the U.S. Army
Medical Research and Materiel Command. The company has two
additional pain treatment product candidates, ARX-02 and ARX-03,
which have completed Phase 2 clinical development. 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 future
financial results, including 2013 financial guidance and cash
forecast, use of proceeds from the recently completed financing,
the process and timing of anticipated future development of
AcelRx's product candidates, the potential acceptance by the FDA of
the NDA for Zalviso and the timing thereof, therapeutic and
commercial potential of Zalviso and the anticipated timing,
therapeutic and commercial potential of other AcelRx product
candidates. These forward-looking statements are based on
AcelRx's current expectations and inherently involve significant
risks and uncertainties. AcelRx's actual results and the
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to:
AcelRx's ability to submit an NDA and receive regulatory approval
for Zalviso, that fact that FDA may not accept for filing the NDA
for Zalviso or dispute or interpret differently positive clinical
results obtained to date; any delays or inability to obtain and
maintain regulatory approval of its product candidates, including
Zalviso, in the United States and
Europe; its ability to attract
funding partners or collaborators with development, regulatory and
commercialization expertise; its ability to obtain sufficient
financing to commercialize Zalviso; the market potential for its
product candidates; the accuracy of AcelRx's estimates regarding
expenses, capital requirements and needs 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 today with the SEC on
November 5, 2013. 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,
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
Statement of
Operations Data
|
|
|
|
|
|
|
|
Research grant
revenue
|
$
548
|
|
$
166
|
|
$
1,895
|
|
$
719
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development (1)
|
6,548
|
|
6,948
|
|
21,974
|
|
17,113
|
General and
administrative (1)
|
2,310
|
|
1,410
|
|
6,571
|
|
5,290
|
Total operating
expenses
|
8,858
|
|
8,358
|
|
28,545
|
|
22,403
|
Loss from
operations
|
(8,310)
|
|
(8,192)
|
|
(26,650)
|
|
(21,684)
|
|
|
|
|
|
|
|
|
Interest
expense
|
(348)
|
|
(573)
|
|
(1,205)
|
|
(1,765)
|
Other income
(expense), net(2)
|
(2,328)
|
|
183
|
|
(13,340)
|
|
608
|
Net loss
|
$
(10,986)
|
|
$
(8,582)
|
|
$(41,195)
|
|
$(22,841)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.26)
|
|
$
(0.38)
|
|
$
(1.07)
|
|
$
(1.09)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
41,462
|
|
22,633
|
|
38,635
|
|
20,962
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
Research and development
|
$
427
|
|
$
258
|
|
$
1,193
|
|
$
762
|
General and administrative
|
449
|
|
304
|
|
1,242
|
|
871
|
Total
|
$
876
|
|
$
562
|
|
$
2,435
|
|
$
1,633
|
|
|
|
|
|
|
|
|
(2) Other income and
expense includes a $2.4 million and $13.4 million non-cash charge
for the three and nine months ended September 30, 2013,
respectively, related to warrants issued in connection with a
private placement equity financing, completed in June
2012.
|
|
|
|
|
|
|
|
|
|
September 30,
2013
|
|
December 31,
2012
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
75,968
|
|
$
59,763
|
|
|
|
|
Total
assets
|
80,661
|
|
64,520
|
|
|
|
|
Total
liabilities
|
27,456
|
|
30,673
|
|
|
|
|
Total stockholders'
equity
|
53,205
|
|
33,847
|
|
|
|
|
(Logo:
http://photos.prnewswire.com/prnh/20130226/MM67303LOGO)
SOURCE AcelRx Pharmaceuticals, Inc.