News Release

AcelRx Pharmaceuticals Reports Fourth Quarter and Full Year 2013 Financial Results
"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
Fourth Quarter and Full Year 2013 Financial Results
Net income for the fourth quarter of 2013 was
During the fourth quarters of 2013 and 2012, AcelRx recognized revenue of
Research and development (R&D) expenses for the quarter ended
Selling, general and administrative (SG&A) expenses were
Other income and expense includes a
For the twelve months ended
R&D expenses for 2013 totaled
As of
Review of Recent Accomplishments and Corporate Update
- The Zalviso New Drug Application (NDA) was accepted for filing by the
FDA onNovember 26, 2013 . The acceptance indicates theFDA has determined that the application is sufficiently complete to permit a substantive review and theFDA has subsequently confirmed a PDUFA action date ofJuly 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 inDecember 2013 covering the territory of theEuropean Union , certain other European countries andAustralia 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 theFDA to seek the agency's feedback on future development plans for ARX-04. TheFDA 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. TheFDA confirmed that the Phase 2 bunionectomy trial could be considered as an adequate and well-controlled study. Consistent withFDA 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 withHercules Technology Growth Capital, Inc. that extended AcelRx's previous relationship with Hercules, which was established inJune 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
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
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
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
Total operating expenses for 2014 are anticipated to be in the range of
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,
About
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
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
Jim Welch, Chief Financial Officer, 650.216.3511, jwelch@acelrx.com