AcelRx Pharmaceuticals Reports Fourth Quarter and Full-Year 2012 Financial Results

  AcelRx Pharmaceuticals Reports Fourth Quarter and Full-Year 2012 Financial
                                   Results

PR Newswire

REDWOOD CITY, Calif., March 12, 2013

REDWOOD CITY, Calif., March 12, 2013 /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 and breakthrough pain, today reported financial results for
the fourth quarter and year ended December 31, 2012, and provided a corporate
update.

(Logo: http://photos.prnewswire.com/prnh/20130226/MM67303LOGO)

"We made important strides in the advancement of our sublingual Sufentanil
NanoTab PCA System for the management of moderate to severe post-operative
pain in 2012 and early 2013. We announced positive results from two completed
Phase 3 clinical trials, and we expect the results from our third and final
planned Phase 3 trial of the NanoTab System in the second quarter of 2013,"
stated Richard King, President and CEO of AcelRx. Mr. King added,"In
addition, in December 2012, we strengthened our balance sheet when we raised
$48 million in gross proceeds, $44 million in net proceeds, through a public
offering of our common stock. These funds will provide the capital needed to
submit an NDA for the NanoTab System, expected in the third quarter of 2013,
and to continue with commercial preparations for launch of the product in the
U.S."

Fourth Quarter and Full Year Financial Results

Net loss for the fourth quarter of 2012 was $10.5 million, or $0.41 per share,
compared with a net loss of $6.4 million, or $0.33 per share, for the fourth
quarter of 2011. Common shares used in calculating basic and diluted earnings
per share were 25,587,614 for the fourth quarter of 2012 compared to
19,567,778 common shares for the fourth quarter of 2011.

During the fourth quarter of 2012, AcelRx recognized revenue of $1.7 million,
compared to $624,000 for the same period in the previous year, related to a
research grant from the U.S. Army Medical Research and Materiel Command, or
USAMRMC, for development of its ARX-04 product candidate, a Sufentanil
NanoTab^® for the treatment of moderate-to-severe acute pain.

Research and development, or R&D, expenses for the quarter ended December 31,
2012 totaled $7.8 million, compared with $4.7 million for the fourth quarter
of 2011. The increase was primarily due to advancement of our clinical
programs for the Sufentanil NanoTab PCA System, AcelRx's lead product
candidate for the treatment of post-operative pain and ARX-04. General and
administrative expenses were $1.9 million for the quarter ended December 31,
2012, compared with $1.7 million for the quarter ended December 31, 2011, an
increase primarily from higher legal costs related to intellectual property.

For the year ended December 31, 2012, AcelRx reported a net loss of $33.4
million, or $1.51 per share, compared with a net loss of $20.1 million, or
$1.16 per share, for the same period in 2011. Common shares used in
calculating basic and diluted earnings per share were 22,124,637 for the year
ended December 31, 2012 compared to 17,344,727 for the year ended December 31,
2011.

As of December 31, 2012, AcelRx had cash, cash equivalents and investments of
$59.8 million, compared to $35.8 million at December 31, 2011.

Review of Recent Accomplishments and Corporate Update

  oOn March 4, 2013, AcelRx announced positive top-line results from a
    pivotal Phase 3 double-blind, placebo-controlled efficacy and safety
    clinical trial for the NanoTab System. This trial involved 178 adult
    patients recruited at 13 U.S. sites following major open abdominal
    surgery, and focused on the management of acute pain for up to 72 hours
    after the first study dose was given shortly after completion of surgery.
    The primary endpoint for this trial was the time weighted summed pain
    intensity difference to baseline over 48 hours, or SPID-48. The top-line
    data demonstrated that patients receiving sufentanil NanoTabs realized a
    significantly greater SPID-48 during the study period than placebo-treated
    patients (p=0.001). Secondary endpoint data also showed that 24 hours and
    72 hours after first dose, the SPID was significantly greater in the
    sufentanil-treated patients than in the placebo-treated patients (p<0.001
    and p=0.004, respectively). Further, sufentanil NanoTab treatment in this
    study was well tolerated, with the rate of adverse events being similar in
    both the active and placebo groups, and adverse events were generally mild
    to moderate in nature.
  oIn November 2012, AcelRx announced positive top-line results for the
    NanoTab System in a Phase 3 open-label, active-comparator study evaluating
    the efficacy and safety of the Sufentanil NanoTab System versus IV PCA
    with morphine, a frequently used post-operative pain treatment in the
    hospital setting. The top-line data showed that the NanoTab System met its
    primary endpoint of non-inferiority in patient global assessment, or PGA,
    with method of pain control in comparison to IV PCA with morphine.
    Additional analyses also showed that the NanoTab System was statistically
    significantly superior to IV PCA morphine for the PGA measurement. In
    addition, using validated assessment tools, nurses managing patients in
    the study and the patients themselves reported that they had significantly
    greater Overall Satisfaction with the NanoTab System compared to IV PCA
    morphine and significantly greater Overall Ease of Care with the NanoTab
    System compared to IV PCA morphine.
  oA second placebo-controlled Phase 3 trial with the Sufentanil NanoTab PCA
    System continues to enroll patients following hip or knee replacement
    surgery with a target of enrolling approximately 400 patients. Dosing of
    the final subject in this study is expected in late March or early April
    2013 and top-line results should be available during the second quarter of
    2013. The primary endpoint for the orthopedic placebo-controlled Phase 3
    study is the sum of pain intensity difference to baseline over 48 hours,
    or SPID-48. 
  oIn early November 2012, AcelRx dosed the first patient in a Phase 2 study
    for ARX-04, its single dose sufentanil NanoTab product candidate for the
    management of acute pain. The study is funded by a grant from the U.S.
    Army Medical Research and Materiel Command, or USAMRMC, and enrolled
    approximately 100 patients following bunionectomy surgery, randomizing
    them into one of three groups to receive one of two sufentanil NanoTab
    dosage amounts (20 mcg or 30 mcg) or placebo. Dosing has been completed
    and we expect to announce top-line results for this trial in the second
    quarter of 2013.
  oIn October 2012, the European Medicines Agency, or EMA, notified AcelRx
    that it will permit registration of the Sufentanil NanoTab PCA System via
    the centralized procedure. This procedure will allow AcelRx to submit a
    single Marketing Authorization Application to the EMA for approval to
    market ARX-01 in all 27 EU member states, as well as in the 4 European
    Free Trade Association countries.
  oIn December 2012, AcelRx completed a public offering of common stock
    resulting in gross proceeds of $48 million, $44 million in net proceeds
    after deducting commissions and offering expenses.
  oDuring 2012, the U.S. Patent and Trademark Office, or USPTO, issued five
    patents covering AcelRx's proprietary NanoTab technology and in early
    2013, the USPTO issued the first NanoTab System device related patent.
    AcelRx has now received a total of six U.S. patents and two European
    patents underpinning its four product development programs, proprietary
    NanoTab technology and NanoTab System device.

Financial Outlook

AcelRx anticipates that quarterly R&D expenses for both the first and second
quarters of 2013 will be in line with, or modestly higher than the R&D
expenses experienced in fourth quarter of 2012 as AcelRx conducts and
completes the Phase 3 clinical trials and prepares an NDA for the NanoTab
System, and completes the ARX-04 Phase 2 clinical study. The development of
ARX-04 beyond Phase 2 is dependent on the identification of additional funding
from USAMRMC or other sources. Additionally, AcelRx anticipates modest
increases in general and administrative expenses due to costs associated with
commercial preparations for launch of the NanoTab System in the US, and as
AcelRx expands its corporate infrastructure to support development of its
product candidates.

AcelRx believes its current cash, cash equivalents and investments are
sufficient to fund operations into the third quarter of 2013.

Conference Call

AcelRx will conduct a conference call and webcast today, March 12, 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 (800) 860-2442 for domestic callers,
(866) 605-3852 for Canadian callers, or (412) 858-4600 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 2012 Financial
results. 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,
the Sufentanil NanoTab PCA System, 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. The NanoTab System has successfully completed two of its
three planned Phase 3 clinical trials and a New Drug Application submission is
planned for the third quarter of 2013. AcelRx recently completed enrollment in
a Phase 2 study for ARX-04, a sufentanil formulation for the treatment of
moderate-to-severe acute pain, funded through a grant from USAMRMC, and
top-line results are expected in the second quarter of 2013. 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 the process and timing of anticipated future
clinical development of AcelRx Pharmaceuticals' product candidates, including
the release of the Sufentanil NanoTab PCA System top-line clinical trial data,
the release and anticipated timing of additional NanoTab System clinical trial
data, the potential submission of an NDA for NanoTab System and the timing
thereof, therapeutic and commercial potential of NanoTab System and the
anticipated timing and therapeutic and commercial potential of other AcelRx
Pharmaceuticals' product candidates. 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: the ability of AcelRx
Pharmaceuticals to successfully complete the clinical trials for the
sufentanil NanoTab System, that fact that subsequent analyses of the top-line
data may lead to different (including less favorable) interpretations of the
results than the analyses conducted to date or may identify important
implications of the study that are not reflected in these statements, or be
subject to differing interpretations by the regulatory agencies; the success,
cost and timing of all product development activities and clinical trials; the
uncertain clinical development process, including the risk that clinical
trials, have an effective design, enroll a sufficient number of patients, or
be completed on schedule, if at all; any delays or inability to obtain and
maintain regulatory approval of its product candidates in the United States
and Europe; its ability to obtain adequate clinical supplies of the drug and
device components of its product candidates; its ability to attract funding
partners or collaborators with development, regulatory and commercialization
expertise; its ability to obtain sufficient financing to complete registration
of its product candidates in the United States and Europe; the market
potential for its product candidates; the accuracy of AcelRx Pharmaceuticals'
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 Annual Report on Form 10-K filed with the SEC on March 12,
2013. 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,
                          2012          2011          2012         2011
Statement of Operations
Data
Research grant revenue    $   1,675  $    624   $  2,394   $  1,072
Operating expenses:
Research and development  7,795         4,702         24,908       13,624
^(1)
General and               1,909         1,715         7,199        6,800
administrative ^(1)
Total operating expenses  9,704         6,417         32,107       20,424
Loss from operations      (8,029)       (5,793)       (29,713)     (19,352)
Interest expense          (518)         (417)         (2,283)      (2,309)
Interest income and Other (1,975)       (163)         (1,367)      1,560
income (expense), net
Net loss                  $  (10,522)  $  (6,373)   $ (33,363)  $ (20,101)
Basic and diluted net     $          $   (0.33)  $          $  
loss per common share     (0.41)                      (1.51)      (1.16)
Shares used in computing
basic and diluted net     25,588        19,568        22,125       17,345
loss per common share
 (1) Includes the following noncash, stock-based
compensation expense:
 Research and  $    236  $    207  $    998  $    785
development
 General and   281           280           1,152        1,048
administrative
 Total
non-cash, stock-based     $    517  $    487  $  2,150   $  1,833
expense
                          December 31,  December 31,
                          2012          2011
Balance Sheet Data
Cash, cash equivalents    $          $  
and investments           59,763        35,785
Total assets              64,520        40,835
Total liabilities         30,673        23,367
Total stockholders'       33,847        17,468
equity



SOURCE AcelRx Pharmaceuticals, Inc.

Website: http://www.acelrx.com
Contact: Jim Welch, Chief Financial Officer, +1-650-216-3511,
jwelch@acelrx.com