REDWOOD CITY, Calif.,
March 9, 2015 /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 reported financial results for the three and
twelve months ended December 31,
2014.
Fourth Quarter 2014 Financial Results
Net loss for the fourth quarter of 2014 was $13.8 million, or $0.32 basic and diluted net loss per share,
compared to $17.8 million net income,
or $0.41 basic net income per share
and $0.39 diluted net income per
share, for the fourth quarter of 2013.
Net loss in the fourth quarter as compared to net income in the
fourth quarter last year was primarily due to the receipt of a
$30.0 million upfront payment under
the collaboration agreement with Grunenthal, of which $27.4 million was recognized as revenue in the
fourth quarter of 2013. In the fourth quarter of 2014, operating
expenses of $12.0 million increased
by $4.4 million from $7.6 million in the fourth quarter of 2013,
primarily due to research and development activities to support
resubmission of the Zalviso NDA, and an increase in headcount and
related expenses in preparation for the potential commercialization
of Zalviso.
During the fourth quarter of 2014, AcelRx recognized
$226,000 of previously deferred
revenue under the collaboration agreement with Grunenthal. During
the fourth quarter of 2013, in addition to the $27.4 million in revenue recognized under the
Grunenthal collaboration, AcelRx also recognized revenue of
$237,000 resulting from reimbursement
for work completed under a research grant from the U.S. Army for
development of ARX-04. Work under this research grant was completed
in the fourth quarter of 2013.
Research and development expenses for the fourth quarter 2014
were $7.3 million, compared to
$4.3 million for the fourth quarter
2013. The increase was primarily due to activities to support
the resubmission of the Zalviso NDA, build-out of the Medical
Affairs team and continued development work on ARX-04.
General and administrative expenses were $4.7 million for the fourth quarter of 2014,
compared to $3.3 million for the
fourth quarter of 2013. The increase was primarily due to
activities in support of the potential commercialization of
Zalviso.
Full Year 2014 Financial Results
For the year ended December 31,
2014, AcelRx reported a net loss of $33.4 million, or $0.77 basic net loss per share and $0.91 diluted net loss per share, compared to
$23.4 million net loss, or
$0.59 basic and diluted net loss per
share for 2013.
Revenue for 2014 was $5.2 million,
including the receipt of a $5 million
milestone payment from Grunenthal for the filing of the Marketing
Authorization Application, or MAA, for Zalviso in Europe.
Revenue for 2013 was $29.5 million
mainly from the upfront payment received from Grunenthal for the
collaboration agreement signed in December
2013.
Research and development expenses for 2014 were $24.5 million, compared to $26.3 million for 2013. The decrease in
research and development expense for 2014 was primarily due to a
high level of activity associated with Phase 3 clinical studies of
Zalviso in 2013. General and administrative expenses were
$18.3 million for 2014, compared to
$9.9 million for 2013. The
increase was primarily due to an increase in headcount, market
research programs and other activities in preparation for the
potential commercialization of Zalviso.
As of December 31, 2014, AcelRx
had cash, cash equivalents and investments of $75.4 million, compared to $103.7 million at December
31, 2013. The decrease in cash during the year was
driven by cash used in operations and investing activities of
$40.2 million, primarily offset by
the $10.0 million drawdown of the
second tranche of the loan agreement with Hercules and receipt of
$1.9 million from the exercise of
stock options and purchase of stock under the employee stock
purchase plan.
Corporate Update
AcelRx recently received correspondence from the U.S. Food and
Drug Administration ("FDA") stating that in addition to the bench
testing and two Human Factors studies it has performed, an
additional clinical study is needed to assess the risk of
inadvertent dispensing and overall risk of dispensing failures.
AcelRx plans to meet with the FDA to discuss and clarify the need
and potential objectives of an additional clinical study for
Zalviso.
Conference Call
AcelRx will conduct a conference call and webcast today,
March 9, 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 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 and selecting the Webcast link
for the Q4 2014 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 Zalviso™
Zalviso is an investigational pre-programmed, non-invasive
system to allow hospital patients with moderate-to-severe acute
pain to self-dose with sufentanil sublingual tablets to manage
their pain. Zalviso consists of sufentanil tablets delivered
by the Zalviso System, a needle-free, handheld,
patient-administered, pain management system (together,
"Zalviso"). Zalviso is designed to help address certain
problems associated with post-operative intravenous
patient-controlled analgesia, by offering:
- A high therapeutic index opioid: Zalviso uses sufentanil, an
opioid that has a high therapeutic index. The therapeutic index is
the ratio of the effective dose versus the lethal dose. In animal
studies, the therapeutic index for sufentanil was approximately 100
times larger than fentanyl and 300 times larger than
morphine.
- A non-invasive route of delivery: Zalviso utilizes a sufentanil
tablet which allows for a sublingual (under the tongue) route of
delivery. Sufentanil is highly lipophilic which provides for rapid
absorption in the fatty cells (or mucosal tissue) found under the
tongue and for rapid transit across the blood-brain barrier to
reach the mu-opioid receptors in the brain. The sublingual delivery
used by Zalviso provides rapid onset of analgesia. The sublingual
delivery system also eliminates the risk of IV-related analgesic
gaps and IV complications, such as catheter-related infections. In
addition, because patients do not require direct connection to an
IV PCA infusion pump through IV tubing, Zalviso allows for ease of
patient mobility.
- A pre-programmed PCA solution: Zalviso allows patients to
self-dose sufentanil sublingual tablets via a pre-programmed,
secure system designed to eliminate the risk of programming
errors.
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 improve the management of moderate-to-severe acute pain in adult
patients in the hospital setting by utilizing a high therapeutic
index opioid, through a non-invasive delivery route via a
pre-programmed, patient-controlled analgesia device. AcelRx has
announced positive results from each of the three completed Phase 3
clinical trials for Zalviso, has submitted an NDA to the FDA
seeking approval for Zalviso in the treatment of moderate-to-severe
acute pain in adult patients in the hospital setting and on
July 25, 2014, received a Complete
Response Letter from the FDA. AcelRx recently received
correspondence from the FDA stating that in addition to the bench
testing and two Human Factors studies AcelRx has performed, an
additional clinical study is needed to assess the risk of
inadvertent dispensing and overall risk of dispensing failures.
AcelRx plans to meet with the FDA to discuss and clarify the need
and potential objectives of an additional clinical study for
Zalviso. AcelRx plans to initiate a Phase 3 clinical trial for
ARX-04, a product candidate for the treatment of moderate-to-severe
acute pain in a medically supervised setting. 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 the process and timing of anticipated
future development of AcelRx's product candidates, including
Zalviso; the Zalviso NDA submission and the CRL; AcelRx's plans to
meet with the FDA to discuss and clarify the need and potential
objectives of an additional clinical study for Zalviso; the Type A
meeting held with the FDA to discuss the CRL; the tasks AcelRx has
completed to address the issues raised in the CRL, and anticipated
resubmission of the Zalviso NDA to the FDA, including the scope of
the resubmission and the timing of the resubmission and FDA review
time; the impact, if any, of the FDA's review of the amendments to
the Zalviso NDA that were not previously reviewed; and the
therapeutic and commercial potential of AcelRx Pharmaceuticals'
product candidates, including Zalviso.
These forward-looking statements are based on AcelRx
Pharmaceuticals' current expectations and inherently involve
significant risks and uncertainties. AcelRx Pharmaceuticals' 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 Pharmaceuticals' ability to receive regulatory
approval for Zalviso; any delays or inability to obtain and
maintain regulatory approval of its product candidates, including
Zalviso, in the United States and
Europe; the success, cost and
timing of all product development activities and clinical trials;
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 Pharmaceuticals' U.S. Securities and
Exchange Commission filings and reports, including its Quarterly
Report on Form 10-Q filed with the SEC on November 10, 2014. AcelRx Pharmaceuticals
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,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Collaboration
agreement
|
$ 226
|
|
$ 27,370
|
|
$ 5,217
|
|
$ 27,370
|
Research
grant
|
-
|
|
237
|
|
-
|
|
2,132
|
Total
revenue
|
226
|
|
27,607
|
|
5,217
|
|
29,502
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development (1)
|
7,281
|
|
4,318
|
|
24,520
|
|
26,292
|
General and
administrative (1)
|
4,724
|
|
3,306
|
|
18,346
|
|
9,877
|
Total operating
expenses
|
12,005
|
|
7,624
|
|
42,866
|
|
36,169
|
Loss from
operations
|
(11,779)
|
|
19,983
|
|
(37,649)
|
|
(6,667)
|
|
|
|
|
|
|
|
|
Interest
expense
|
(821)
|
|
(313)
|
|
(2,639)
|
|
(1,518)
|
Interest income and
other income (expense), net(2)
|
(1,218)
|
|
(1,901)
|
|
6,935
|
|
(15,241)
|
Net income
(loss)
|
$ (13,818)
|
|
$ 17,769
|
|
$ (33,353)
|
|
$ (23,426)
|
|
|
|
|
|
|
|
|
Basic net income
(loss) per common share
|
$ (0.32)
|
|
$ 0.41
|
|
$ (0.77)
|
|
$ (0.59)
|
|
|
|
|
|
|
|
|
Diluted net income
(loss) per common share
|
$ (0.32)
|
|
$ 0.39
|
|
$ (0.91)
|
|
$ (0.59)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income (loss) per common share
|
43,709
|
|
43,044
|
|
43,427
|
|
39,747
|
|
|
|
|
|
|
|
|
Shares used in
computing diluted net income (loss) per common
share(3)
|
43,709
|
|
45,755
|
|
44,322
|
|
39,747
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
$ 645
|
|
$ 464
|
|
$ 2,252
|
|
$ 1,657
|
General and administrative
|
727
|
|
580
|
|
2,188
|
|
1,822
|
Total
|
$ 1,372
|
|
$ 1,044
|
|
$ 4,440
|
|
$ 3,479
|
|
|
|
|
|
|
|
|
(2)
|
Interest income and
other income (expense), net includes $1.2 million in non-cash
charges and $7.0 million in non-cash income for the three and
twelve months ended December 31, 2014, respectively, and $0.7
million and $14.1 million in non-cash charges during the three and
twelve months ended December 31, 2013, respectively, related to
revaluation of the PIPE warrants issued in connection with a
private placement equity financing, completed in June
2012.
|
|
|
|
|
|
|
|
|
|
(3)
|
Diluted net income
per share for the three months ended December 31, 2013 includes the
dilutive effect of warrants, stock options and stock awards
outstanding of 2.7 million shares. Basic net loss per share for the
year ended December 31, 2014 includes $7.0 million in non-cash
income related to the revaluation of PIPE warrants, which was
deducted from net loss in order to arrive at the numerator for the
calculation of diluted EPS, and 0.9 million shares were added to
the denominator (using the treasury stock method) to reflect the
dilutive effect of the PIPE warrants.
|
|
|
|
|
|
|
|
|
|
December 31,
2014
|
|
December 31,
2013
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
75,350
|
|
$
103,663
|
|
|
|
|
Total
assets
|
86,447
|
|
110,031
|
|
|
|
|
Total
liabilities
|
39,791
|
|
36,872
|
|
|
|
|
Total stockholders'
equity
|
46,656
|
|
73,159
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE AcelRx Pharmaceuticals, Inc.