News Release

AcelRx Pharmaceuticals Reports Third Quarter 2013 Financial Results
"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
Third Quarter and Nine Months Financial Results
Net loss for the third quarter of 2013 was
During the third quarters of 2013 and 2012, AcelRx recognized revenue of
Research and development, or R&D, expenses for the quarter ended
General and administrative expenses were
Other income and expense includes a
For the nine months ended
R&D expenses for the nine months ended
As of
Review of Recent Accomplishments and Corporate Update
- On
September 27, 2013 , AcelRx submitted an NDA to theFDA 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. andEurope , 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 atConceptus, 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 theAmerican Society of Anesthesiologists meeting inSan Francisco . Results demonstrated that patients receiving Zalviso realized a significantly greater Summed Pain Intensity Difference to baseline for 48 hours (SPID -48), theFDA -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
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
Conference Call
AcelRx will conduct a conference call and webcast today,
About
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
SELECTED FINANCIAL DATA |
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(in thousands, except per share data) |
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(unaudited) |
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Three Months Ended |
Nine Months Ended |
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September 30, |
September 30, |
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2013 |
2012 |
2013 |
2012 |
||||
Statement of Operations Data |
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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 |
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(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. |
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September 30, 2013 |
December 31, 2012 |
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Selected Balance Sheet Data |
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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 |
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SOURCE
Jim Welch, Chief Financial Officer, 650.216.3511, jwelch@acelrx.com