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AcelRx Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2015 Financial Results
Corporate Update and 2016 Objectives
- ARX-04 ER and Postoperative Studies: In
December 2015 , AcelRx, along with representatives from its partner at theDepartment of Defense , held a pre-NDA meeting with theFDA to discuss the New Drug Application, or NDA, for ARX-04 (sufentanil sublingual tablet, 30 mcg) for the treatment of moderate-to-severe acute pain in a medically supervised setting. Based on these discussions, AcelRx decided to expand enrollment in the open-label SAP302 study, which was initiated inOctober 2015 in patients who present with moderate-to-severe acute pain in the emergency room, or ER. The extension phase of SAP302 is expected to be initiated this month, and will allow participants to be administered multiple doses of ARX-04, given hourly as needed for pain, for up to 4 doses. A new study of ARX-04, known as SAP303, was initiated last week in postoperative patients with moderate-to-severe acute pain. SAP303 will focus on enrolling patients older than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. Both SAP302 and SAP303 are expected to be completed by the third quarter of 2016. - ARX-04 NDA Submission: AcelRx intends to pursue an indication for ARX-04 for the management of moderate-to-severe acute pain in a medically supervised setting. Assuming successful completion of the above studies by the third quarter of 2016, the company anticipates submitting the NDA for ARX-04 in the fourth quarter of 2016.
- Zalviso Open-Label Phase 3 Study: The company continues to advance the regulatory process for Zalviso. AcelRx has completed a protocol review with the
FDA of an open-label clinical study, known as IAP312, of Zalviso in post-operative patients. This study will primarily measure the rate of device errors, including the failure to dispense medication as well as the incidence of misplaced or dropped tablets. AcelRx expects to initiate the study later this month. - Zalviso NDA Submission: Pending timely completion of the IAP312 study, AcelRx expects to resubmit the NDA for Zalviso by the end of 2016.
- Zalviso EU Commercial Launch: In
September 2015 , theEuropean Commission approved Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. The marketing authorization was granted for the 28 EU member states as well as for the European Economic Area countries,Norway ,Iceland andLiechtenstein .Grunenthal Group , AcelRx's licensee inEurope , has been working with the member states of the EU and EEA to ensure that Zalviso is made available to those patients who would benefit from an effective and reliable solution for their acute moderate-to-severe post-surgical pain. Grunenthal expects the product to be available to Western European patients in the first half of 2016.
"Having obtained significant input from the
Fourth Quarter 2015 Financial Results
Net loss for the fourth quarter of 2015 was
During the fourth quarter of 2015, AcelRx recognized revenue of
Cost of goods sold was
Research and development expenses for the fourth quarter of 2015 were
General and administrative expenses were
Total other expense increased in the fourth quarter of 2015, as compared to the fourth quarter of 2014, primarily as a result of the non-cash interest expense related to the monetization of the expected royalty stream, or Royalty Monetization, from the sales of Zalviso in the EU by Grunenthal to
Full Year 2015 Financial Results
For the year ended
Revenue for 2015 was
Research and development expenses for 2015 were
Cost of goods sold was
General and administrative expenses for 2015 were
As of
Assuming the timely completion of the clinical studies and accomplishments of the 2016 Corporate Objectives listed above, AcelRx anticipates cash, cash equivalents and investments to be between
Conference Call
AcelRx will conduct a conference call and webcast today,
About
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index opioid, sublingually through a disposable, pre-filled, single-dose applicator. AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and has advanced ARX-04 into a study (SAP302) in emergency room patients. In addition, AcelRx initiated SAP303 in
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 development of AcelRx's product candidates, including the process and timing of anticipated future development of Zalviso and ARX-04; timing for initiation and completion along with anticipated results of IAP312 for Zalviso; anticipated results and timing of the completion of the SAP302 and SAP303 studies for ARX-04; anticipated cash balance at year-end 2016; launch timing and commercial availability for Zalviso in
Selected Financial Data |
|||||||
(in thousands, except per share data) |
|||||||
(unaudited) |
|||||||
Three Months Ended |
Twelve Months Ended |
||||||
December 31, |
December 31, |
||||||
2015 |
2014 |
2015 |
2014 |
||||
Statement of Comprehensive Loss Data |
|||||||
Collaboration agreement revenue |
$ 327 |
$ 226 |
$ 14,857 |
$ 5,217 |
|||
Contract and other revenue |
1,403 |
- |
4,406 |
- |
|||
Total revenue |
1,730 |
226 |
19,263 |
5,217 |
|||
Operating costs and expenses: |
|||||||
Cost of goods sold (1) |
1,770 |
- |
1,770 |
- |
|||
Research and development (1) |
3,479 |
7,281 |
22,488 |
24,520 |
|||
General and administrative (1) |
4,017 |
4,724 |
14,203 |
18,346 |
|||
Restructuring costs |
- |
- |
756 |
- |
|||
Total operating expenses |
9,266 |
12,005 |
39,217 |
42,866 |
|||
Income (loss) from operations |
(7,536) |
(11,779) |
(19,954) |
(37,649) |
|||
Other (expense) income: |
|||||||
Interest expense |
(681) |
(821) |
(2,977) |
(2,639) |
|||
Interest income and other income (expense), net(2) |
(195) |
(1,218) |
1,720 |
6,935 |
|||
Non-cash interest expense on liability related to sale of future royalties to PDL |
(2,146) |
- |
(2,428) |
- |
|||
Total other (expense) income |
(3,022) |
(2,039) |
(3,685) |
4,296 |
|||
Provision for income taxes |
12 |
- |
(760) |
||||
Net income (loss) |
$ (10,546) |
$ (13,818) |
$ (24,399) |
$ (33,353) |
|||
Basic net income (loss) per common share |
$ (0.24) |
$ (0.32) |
$ (0.55) |
$ (0.77) |
|||
Shares used in computing basic net income (loss) per common share |
44,568 |
43,709 |
44,300 |
43,427 |
|||
Diluted net income (loss) per common share |
$ (0.24) |
$ (0.32) |
$ (0.60) |
$ (0.91) |
|||
Shares used in computing diluted net income (loss) per common share |
44,568 |
43,709 |
44,468 |
44,322 |
|||
(1) Includes the following non-cash, stock-based compensation expense: |
|||||||
Cost of goods sold |
$ 67 |
$ - |
$ 67 |
$ - |
|||
Research and development |
620 |
645 |
2,587 |
2,252 |
|||
General and administrative |
503 |
727 |
2,356 |
2,188 |
|||
Total |
$ 1,190 |
$ 1,372 |
$ 5,010 |
$ 4,440 |
|||
(2) Interest income and other income (expense) includes $0.3 million in non-cash charges and $2.1 million in non-cash income for the three and twelve months ended December 31, 2015, respectively, as compared to $1.2 million in non-cash charges and $7.0 million in non-cash income for the three and twelve months ended December 31, 2014, respectively, related to warrants issued in connection with a private placement equity financing, completed in June 2012. |
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December 31, 2015 |
December 31, 2014 |
||||||
Selected Balance Sheet Data |
|||||||
Cash, cash equivalents and investments |
$ 113,464 |
$ 75,350 |
|||||
Total assets |
127,785 |
86,416 |
|||||
Total liabilities |
94,672 |
39,760 |
|||||
Total stockholders' equity |
33,113 |
46,656 |
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SOURCE
Timothy E. Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com: or Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com