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AcelRx Pharmaceuticals Reports Second Quarter 2013 Financial Results
"With the successful completion of our Zalviso™ clinical program that includes data from all three Phase 3 studies, each of which met its primary endpoint, we are preparing to submit our New Drug Application (NDA), by the end of the third quarter," stated
Second Quarter Financial Results
Net loss for the second quarter of 2013 was
During the second quarters of 2013 and 2012, AcelRx recognized revenue of
Research and development (R&D) expenses for the quarter ended
General and administrative expenses were
Other income and expense includes the
For the six months ended
R&D expenses for the six months ended
As of
Review of Recent Accomplishments and Corporate Update
- On
July 23, 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 approximately$47.9 million after deducting underwriting discounts and commissions and other estimated expenses payable by AcelRx. AcelRx intends to use the net proceeds from this offering to fund potential regulatory approval of Zalviso both inthe United States andEurope , our continuing preparation for and the potential commercial launch of Zalviso inthe United States , and for working capital and other general corporate purposes. - On
June 27, 2013 , AcelRx held an investor day inNew York City , introducing the trade name of Zalviso for the sufentanil NanoTab PCA System. Presentations delivered at the meeting covered a range of topics, including insights from an anesthesiologist and an orthopedic surgeon on the potential role of Zalviso in the management of post-operative patients and additional data from the Zalviso Phase 3 clinical program. We also discussed AcelRx's intent to pursue a broad label for Zalviso for the treatment of moderate-to-severe acute pain in the hospital setting inthe United States . - On
May 21, 2013 , AcelRx announced top-line data demonstrating that Zalviso met its primary endpoint in a pivotal Phase 3 trial comparing the efficacy and safety of Zalviso to placebo in the management of acute post-operative pain after major orthopedic surgery. Utilizing a randomized, double-blind, placebo-controlled design, this pivotal Phase 3 trial enrolled 426 adult patients at 34 U.S. sites. The primary endpoint evaluated pain intensity difference to baseline over the 48-hour study period, orSPID -48, in patients following major orthopedic surgery, specifically knee or hip replacement. Patients receiving Zalviso demonstrated a significantly greaterSPID -48 (pain reduction) compared to placebo-treated patients during the trial period (p<0.001). Treatment-emergent adverse events were generally mild-to-moderate in nature and similar for the majority of adverse events between Zalviso and placebo treated patients, with the exception of nausea, vomiting, itching and dizziness, which were higher in the sufentanil treated group. Two patients (one each in the Zalviso group and placebo group) experienced a severe adverse event considered possibly or probably related to the trial drug by the investigator. - On
May 2, 2013 AcelRx presented five posters relating to clinical and pharmacokinetic data from the Phase 3 Zalviso clinical program, as well as data from design and human factors studies relating to the Zalviso delivery system at theAmerican Society of Regional Anesthesia and Pain Medicine (ASRA) annual meeting inBoston . In one of these posters, new analyses from the Phase 3 trial comparing Zalviso to intravenous patient-controlled analgesia (IV PCA) with morphine demonstrated that Zalviso had a significantly faster reduction in pain intensity compared to IV PCA morphine (p<0.01). In addition, fewer patients experienced oxygen desaturation events below 95% in the Zalviso-treated group compared to the IV PCA morphine-treated group (p=0.028). Overall, adverse events were similar between groups, and most were generally mild-to-moderate in nature in both groups. - On
April 24, 2013 , AcelRx reported top-line data showing that the primary endpoint was achieved in a placebo-controlled, dose-finding, Phase 2 clinical trial of ARX-04 for moderate-to-severe acute pain. This trial randomized 101 patients following bunionectomy surgery in a 2:2:1 ratio to 30 mcg sufentanil, 20 mcg sufentanil or placebo treatment. Results demonstrated that patients receiving 30 mcg sufentanil NanoTab doses, administered by a healthcare professional, no more frequently than once per hour, had significantly greater pain reduction as measured by Summed Pain Intensity Difference to baseline during the 12-hour trial period (SPID -12) than placebo-treated patients (p=0.003). The clinical study and associated research activities for ARX-04 are funded by a grant from USAMRMC.
Financial Outlook
AcelRx records as revenue the reimbursement received pursuant to the
We anticipate that the quarterly R&D expenses in the second half of 2013 will be lower than the expense recorded in Q2 of 2013, due to lower clinical development costs associated with the Zalviso and ARX-04 programs. These decreases in clinical R&D expenses will be partially offset by costs associated with the preparation of an NDA filing for Zalviso, expected to be submitted to the
Additionally, AcelRx anticipates continued increases in 2013 in general and administrative expense due to costs associated with commercial preparations for the launch of Zalviso in the U.S. and expansion of its corporate infrastructure to support a commercial launch.
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 we 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 recently completed public equity offering, are sufficient to fund operations at least through the end of 2014. We expect our use of cash will decrease during the second half of 2013 compared to the first half of the year as expenditures, primarily R&D expenditures, decline for clinical activity and final payments are made to contract research organizations.
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 recently completed financing, the process and timing of anticipated future development of AcelRx's product candidates, the potential submission of an NDA for Zalviso and the timing thereof, therapeutic and commercial potential of Zalviso and the anticipated timing and 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
SELECTED FINANCIAL DATA |
|||||||
(in thousands, except per share data) |
|||||||
(unaudited) |
|||||||
Three Months Ended |
Six Months Ended |
||||||
June 30, |
June 30, |
||||||
2013 |
2012 |
2013 |
2012 |
||||
Statement of Operations Data |
|||||||
Research grant revenue |
$ 407 |
$ 224 |
$ 1,347 |
$ 553 |
|||
Operating expenses: |
|||||||
Research and development (1) |
6,108 |
5,394 |
15,426 |
10,165 |
|||
General and administrative (1) |
2,070 |
1,776 |
4,261 |
3,880 |
|||
Total operating expenses |
8,178 |
7,170 |
19,687 |
14,045 |
|||
Loss from operations |
(7,771) |
(6,946) |
(18,340) |
(13,492) |
|||
Interest expense |
(403) |
(598) |
(857) |
(1,192) |
|||
Other income (expense), net(2) |
(9,273) |
350 |
(11,012) |
425 |
|||
Net loss |
$ (17,447) |
$ (7,194) |
$(30,209) |
$(14,259) |
|||
Basic and diluted net loss per common share |
$ (0.47) |
$ (0.35) |
$ (0.81) |
$ (0.71) |
|||
Shares used in computing basic and diluted net loss per common share |
37,263 |
20,627 |
37,198 |
20,115 |
|||
(1) Includes the following non-cash, stock-based compensation expense: |
|||||||
Research and development |
$ 411 |
$ 254 |
$ 766 |
$ 505 |
|||
General and administrative |
391 |
276 |
793 |
566 |
|||
Total non-cash, stock-based expense |
$ 802 |
$ 530 |
$ 1,559 |
$ 1,071 |
|||
(2) Other income and expense includes a $9.3 million and $11.0 million and non-cash charge in the for the three and six months ended June 30, 2013, respectively, related to warrants issued in connection with a private placement equity financing, completed in June 2012. |
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June 30, 2013 |
December 31, 2012 |
||||||
Selected Balance Sheet Data |
|||||||
Cash, cash equivalents and investments |
$ 36,844 |
$ 59,763 |
|||||
Total assets |
40,797 |
64,520 |
|||||
Total liabilities |
34,756 |
30,673 |
|||||
Total stockholders' equity |
6,041 |
33,847 |
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SOURCE
Jim Welch, Chief Financial Officer, 650.216.3511, jwelch@acelrx.com