REDWOOD CITY, Calif.,
March 3, 2014 /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 twelve months ended December
31, 2013.
"AcelRx made strong progress in 2013 with the successful
completion of the Zalviso™ (sufentanil sublingual NanoTab system)
Phase 3 program, the filing and acceptance of the NDA for Zalviso,
the execution of a commercial partnership agreement with Grunenthal
for Zalviso that covers Europe and
Australia, and agreement with FDA
on a Phase 3 program for ARX-04, an investigational single-dose
sublingual sufentanil NanoTab for moderate-to-severe acute pain,"
stated Richard King, president and
CEO of AcelRx. "As we begin 2014, we are advancing our U.S.
commercial capability and preparing for a potential Zalviso
approval in third quarter of 2014. We are also readying Zalviso for
MAA filing in Europe, and
preparing to initiate a Phase 3 clinical program for ARX-04 in the
second half of this year."
Fourth Quarter and Full Year 2013 Financial Results
Net income for the fourth quarter of 2013 was $17.8 million, or $0.41 per share, compared with a net loss of
$10.5 million, or $0.41 per share for the fourth quarter of 2012.
During the fourth quarter of 2013, AcelRx received a
$30.0 million upfront payment from
Grunenthal GmbH associated with the Zalviso commercialization
agreement in the EU and Australia,
of which $27.4 million was recognized
as revenue in the quarter. Excluding the $27.4 million of revenue recognized from the
Grunenthal collaboration, and excluding a $1.2 million one-time non-cash charge associated
with the Hercules debt renegotiation and $0.7 million non-cash expense resulting from the
liability accounting related to warrants issued in connection with
the PIPE financing completed in June
2012, the net loss for the fourth quarter of 2013 was
$7.7 million, or $0.18 per share.
During the fourth quarters of 2013 and 2012, AcelRx recognized
revenue of $27.6 million and
$1.7 million, respectively. The
fourth quarter of 2013 revenue includes $27.4 million of revenue recognized from the
$30.0 million upfront payment from
Grunenthal and $0.2 million of
reimbursement for work completed under a research grant from the
U.S. Army Medical Research and Materiel Command (USAMRMC), for
development of ARX-04. Fourth quarter of 2012 revenue consisted of
$1.7 million in reimbursement for
work associated with the USAMRMC grant.
Research and development (R&D) expenses for the quarter
ended December 31, 2013 totaled
$4.3 million, compared with
$7.8 million for the quarter ended
December 31, 2012. The decrease
in R&D expense reflects completion of the Phase 3 development
for Zalviso by the third quarter of 2013.
Selling, general and administrative (SG&A) expenses were
$3.3 million for the fourth quarter
of 2013, compared with $1.9 million
for the fourth quarter of 2012, due primarily to an increase in
commercial activities related to Zalviso, including increased
market research activities and the initial build of internal
marketing capabilities. Fourth quarter 2013 SG&A expense of
$3.3 million includes $1.0 million in marketing costs.
Other income and expense includes a $0.7
million non-cash charge in the fourth quarter of 2013
resulting from the liability accounting related to 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 fourth quarter of 2013
and its resulting impact on the Black-Scholes valuation of these
warrants. Additionally, in connection with the renegotiated
debt with Hercules, AcelRx recorded in the fourth quarter a
$1.2 million non-cash charge for the
extinguishment of the original Hercules loan that was paid off upon
the signing of the new debt arrangement.
For the twelve months ended December 31,
2013, AcelRx reported a net loss of $23.4 million, or $0.59 per share, compared with a net loss of
$33.4 million, or $1.51 per share for the same period in 2012.
Excluding the $27.4 million
recognized from the Grunenthal upfront payment, the $14.1 million in non-cash expense resulting from
the liability accounting related to the warrants issued in
connection with the PIPE financing completed in June 2012 and the $1.2
million one-time, non-cash charge associated with our debt
renegotiation, adjusted net loss for 2013 was $35.5 million, or $0.89 per share.
R&D expenses for 2013 totaled $26.3
million, compared with $24.9
million in 2012. The increase for 2013 over 2012 was
primarily due to expenditures related to the Zalviso Phase 3
clinical trials that were at their highest levels in the first and
second quarters of 2013. SG&A expenses were $9.9 million for 2013, compared with $7.2 million in 2012, due primarily to an
increase in stock based compensation and commercial activities
related to Zalviso, including increased market research activities
and the initial build of marketing capabilities.
As of December 31, 2013, AcelRx
had cash, cash equivalents and investments of $103.7 million, compared to $59.8 million at December
31, 2012. In July 2013,
AcelRx raised approximately $47.9
million in net proceeds through the issuance of 4.37 million
shares of common stock in an underwritten public offering. In
December 2013, AcelRx received an
upfront licensing fee of $30 million
from Grunenthal GmbH under the terms of a collaboration agreement
for Zalviso in Europe and
Australia and an additional
$6.0 million, net of payments to
Hercules, from the renegotiated debt agreement.
Review of Recent Accomplishments and Corporate Update
- The Zalviso New Drug Application (NDA) was accepted for filing
by the FDA on November 26, 2013. The
acceptance indicates the FDA has determined that the application is
sufficiently complete to permit a substantive review and the FDA
has subsequently confirmed a PDUFA action date of July 27, 2014. The NDA seeks approval of Zalviso
for the management of moderate-to-severe acute pain in adult
patients in the hospital setting.
- AcelRx and Grunenthal GmbH announced a commercial collaboration
in December 2013 covering the
territory of the European Union, certain other European countries
and Australia for Zalviso for
potential use in pain treatment within or dispensed by a hospital,
hospice, nursing home or other medically supervised setting. Under
the terms of the agreement, AcelRx received an upfront cash payment
of $30.0 million and is eligible to
receive approximately $220.0 million
in potential additional milestone payments, based upon successful
regulatory and product development efforts and net sales target
achievements. Grunenthal will also make tiered royalty, supply and
trademark fee payments in the mid-teens to the mid-twenties percent
range on potential net sales of Zalviso in the Grunenthal
territory.
- In December 2013, AcelRx
completed an end of Phase 2 meeting with the FDA to seek the
agency's feedback on future development plans for ARX-04. The FDA
requested a 500 patient safety database, consisting of 100 patients
exposed to multiple doses and 400 patients exposed to a single dose
of ARX-04. The FDA confirmed that the Phase 2 bunionectomy trial
could be considered as an adequate and well-controlled study.
Consistent with FDA guidance at the meeting, AcelRx plans a single
additional Phase 3 registration trial, to be conducted in a
visceral, or soft tissue, model of pain, the primary endpoint for
which will be Summed Pain Intensity Difference over 12 hours
(SPID-12). AcelRx plans to begin this Phase 3 study during the
second half of the 2014 and expects that top-line results should be
available during the second half of 2015.
- In December 2013, AcelRx entered
into a new amended and restated credit facility with Hercules
Technology Growth Capital, Inc. that extended AcelRx's previous
relationship with Hercules, which was established in June 2011. The new Hercules credit facility
provides for up to $40.0 million of
new loans. Upon the closing of the new credit facility, AcelRx drew
the initial tranche of $15.0 million,
$9.0 million of which was used to pay
the outstanding balance and fees of the prior Hercules credit
facility.
Financial Outlook
AcelRx records as revenue the reimbursement received pursuant to
the 2011 $5.6 million USAMRMC grant.
Recognition of revenue from this grant has resulted in
recorded revenues of $5.6 million
through December 31, 2013 with no
funding remaining on the USAMRMC grant.
AcelRx expects the first of the Grunenthal regulatory milestones
to be triggered with the planned submission of the MAA in mid-2014,
resulting in a $5.0 million milestone
payment anticipated in the third quarter of 2014.
AcelRx forecasts that quarterly R&D expenses through the end
of 2014 will be relatively consistent across all quarters with
total R&D expenses expected to be in the range of $27 to $29 million for the year.
Additionally, AcelRx anticipates general and administrative
expenses, excluding sales and marketing costs, will increase
gradually quarter over quarter in 2014 as the company builds
infrastructure to support Zalviso's commercial activities.
Consistent with planned commercial preparation, sales and marketing
costs are expected to accelerate over the remaining quarters of
2014 as the company prepares for the possible approval and the
planned commercial launch of Zalviso. In 2014, total SG&A
costs in the $21 to $23 million range
are anticipated, assuming FDA approval for Zalviso in the third
quarter of 2014.
Total operating expenses for 2014 are anticipated to be in the
range of $48 to $52 million.
AcelRx believes its current cash, cash equivalents, investments
and cash available under credit facilities are sufficient to fund
operations at least through 2015, excluding any potential proceeds
from Grunenthal milestones.
Conference Call
AcelRx will conduct a conference call and webcast today,
March 3, 2014 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 Q4 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 in the treatment of
moderate-to-severe acute pain in adult patients in the hospital
setting. 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, during the second
half of 2014. 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 2014 financial guidance and cash
forecast, potential milestones and royalty payments under the
Gruenthal agreement, the process and timing of anticipated future
development of AcelRx's product candidates, including the timing of
potential approval for Zalviso, therapeutic and commercial
potential of Zalviso and the anticipated timing, therapeutic and
commercial potential of other AcelRx product candidates, including
the timing of the Phase 3 trial for ARX-04. 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
receive regulatory approval for Zalviso, that fact that FDA may
dispute or interpret differently 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 receive any milestones
or royalty payments under the Gruenthal agreement; its ability to
obtain sufficient financing to commercialize Zalviso and proceed
with clinical development of ARX-04; the success, cost and timing
of all product development activities and clinical trials,
including the planned Phase 3 ARX-04 trial; 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; 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 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
|
|
Twelve
Months Ended
|
|
December
31,
|
|
December
31,
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
Statement of
Operations Data
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Collaboration
agreement
|
$
27,370
|
|
$
-
|
|
$
27,370
|
|
$
-
|
Research
grant
|
237
|
|
1,675
|
|
2,132
|
|
2,394
|
Total
revenue
|
27,607
|
|
1,675
|
|
29,502
|
|
2,394
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development (1)
|
4,318
|
|
7,795
|
|
26,292
|
|
24,908
|
General and
administrative (1)
|
3,306
|
|
1,909
|
|
9,877
|
|
7,199
|
Total operating
expenses
|
7,624
|
|
9,704
|
|
36,169
|
|
32,107
|
Loss from
operations
|
19,983
|
|
(8,029)
|
|
(6,667)
|
|
(29,713)
|
|
|
|
|
|
|
|
|
Interest
expense
|
(313)
|
|
(518)
|
|
(1,518)
|
|
(2,283)
|
Other income
(expense), net(2)
|
(1,901)
|
|
(1,975)
|
|
(15,241)
|
|
(1,367)
|
Net income
(loss)
|
$
17,769
|
|
$
(10,522)
|
|
$
(23,426)
|
|
$
(33,363)
|
|
|
|
|
|
|
|
|
Basic net income
(loss) per common share
|
$
0.41
|
|
$
(0.41)
|
|
$
(0.59)
|
|
$
(1.51)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income (loss) per common share
|
43,044
|
|
25,588
|
|
39,747
|
|
22,125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
$
464
|
|
$
236
|
|
$
1,657
|
|
$
998
|
General and administrative
|
580
|
|
281
|
|
1,822
|
|
1,152
|
Total
|
$
1,044
|
|
$
517
|
|
$
3,479
|
|
$
2,150
|
|
|
|
|
|
|
|
|
(2) Other income and
expense includes a $0.7 million and $14.1 million non-cash charge
for the three and twelve months ended December 31, 2013,
respectively, related to warrants issued in connection with a
private placement equity financing, completed in June
2012.
|
|
|
|
|
|
|
|
|
|
December 31,
2013
|
|
December 31,
2012
|
|
|
|
|
Selected Balance
Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
103,663
|
|
$
59,763
|
|
|
|
|
Total
assets
|
110,031
|
|
64,520
|
|
|
|
|
Total
liabilities
|
36,872
|
|
30,673
|
|
|
|
|
Total stockholders'
equity
|
73,159
|
|
33,847
|
|
|
|
|
|
|
|
|
|
|
|
|
Logo: http://photos.prnewswire.com/prnh/20130226/MM67303LOGO
SOURCE AcelRx Pharmaceuticals, Inc.