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AcelRx Pharmaceuticals Reports Third Quarter 2017 Financial Results
"In response to the DSUVIA CRL, we are pleased to have compiled and submitted the Briefing Book and request for a Type A meeting with the
Recent Highlights
- Reported successful outcome of ZALVISO Phase 3 IAP312 study on device functionality, achieving the study objective with 2.2% of patients experiencing a device error, which was statistically less than the 5% limit specified in the study objective.
- On track for the resubmission of the NDA for ZALVISO by the end of the year with the intention to resubmit after the DSUVIA Type A meeting.
- Received a CRL in
October 2017 from theFDA regarding its NDA for DSUVIA. A Type A meeting request was submitted to theFDA to discuss the topics covered in the CRL and to confirm plans to move towards resubmission of the DSUVIA NDA.
Third Quarter 2017 Financial Information
September 30, 2017 cash balance of$67.9 million .- Revenue of
$1.5 million , consisting of$1.2 million related to the collaboration with Grunenthal, and$0.3 million related to work performed under theDepartment of Defense (DoD) contract for DSUVIA. The$1.9 million decline from the third quarter of 2016 is mainly attributed to lower invoicing under our DoD contract due to less DSUVIA development work in the quarter. - Cost of goods sold of
$2.0 million related to commercial production of ZALVISO in support of Grunenthal's European launch, as compared to$2.6 million during the third quarter of 2016. - R&D and G&A expenses totaled
$8.3 million , and excluding stock-based compensation was$7.4 million , declining$0.4 million compared to the third quarter of 2016. The decrease was mainly due to the completion of the Phase 3 DSUVIA trials in 2016, and lower ZALVISO-related development costs offset by an increase in DSUVIA-related pre-commercialization expenses. - Net loss for the third quarter of 2017 was
$13.0 million , or$0.28 basic and diluted net loss per share, compared to$11.4 million , or$0.25 basic and diluted net loss per share for the third quarter of 2016. The net loss from operations in the third quarter of 2017 was$8.9 million , compared to$8.0 million during the third quarter last year.
Year-to-Date Financial Information
- For the nine months ended
September 30, 2017 , revenue of$7.2 million , consisting of$6.4 million under the collaboration agreement with Grunenthal, and$0.8 million related to work performed under theDepartment of Defense contract for DSUVIA. This compares to revenue related to those two agreements of$4.7 million and$6.2 million , respectively, for the nine months endedSeptember 30, 2016 . Higher ZALVISO product sales to Grunenthal were offset by the timing of DSUVIA development work reimbursed under our contract with the DoD. - Cost of goods sold of
$9.7 million related to the production of ZALVISO for Grunenthal's European launch, as compared to$9.2 million in the comparable period last year. - R&D and G&A expenses totaled
$28.4 million , and excluding stock-based compensation was$25.4 million , in the nine months endedSeptember 30, 2017 , compared to$26.6 million , and excluding stock-based compensation was$23.4 million , during the nine months endedSeptember 30, 2016 . The increase was primarily due to the IAP312 clinical trial for ZALVISO and DSUVIA-related pre-commercialization expenses. - Net loss of
$41.6 million , or$0.91 basic and diluted net loss per share, compared to$33.5 million , or$0.74 basic and diluted net loss per share for the same period in 2016.
Conference Call
As previously announced, AcelRx will conduct an investment-community conference call on
About
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, DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside
Selected Financial Data |
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(in thousands, except per share data) |
|||||||
(unaudited) |
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Three Months Ended |
Nine Months Ended |
||||||
September 30 |
September 30 |
||||||
2017 |
2016 |
2017 |
2016 |
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Statement of Comprehensive Loss Data |
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Revenue: |
|||||||
Collaboration agreement revenue |
$ 1,225 |
$ 1,562 |
$ 6,444 |
$ 4,669 |
|||
Contract and other revenue |
262 |
1,804 |
811 |
6,253 |
|||
Total revenue |
1,487 |
3,366 |
7,255 |
10,922 |
|||
Operating costs and expenses: |
|||||||
Cost of goods sold (1) |
2,029 |
2,579 |
9,697 |
9,154 |
|||
Research and development (1) |
3,913 |
4,617 |
15,733 |
15,068 |
|||
General and administrative (1) |
4,406 |
4,145 |
12,700 |
11,519 |
|||
Total operating costs and expenses |
10,348 |
11,341 |
38,130 |
35,741 |
|||
Loss from operations |
(8,861) |
(7,975) |
(30,875) |
(24,819) |
|||
Other (expense) income: |
|||||||
Interest expense |
(919) |
(702) |
(2,596) |
(2,069) |
|||
Interest income and other income (expense), net(2) |
(465) |
(360) |
(215) |
300 |
|||
Non-cash interest expense on liability related to sale of future royalties |
(2,768) |
(2,401) |
(7,935) |
(6,921) |
|||
Total other expense |
(4,152) |
(3,463) |
(10,746) |
(8,690) |
|||
Benefit (provision) for income taxes |
- |
36 |
(2) |
34 |
|||
Net loss |
$(13,013) |
$(11,402) |
$(41,623) |
$(33,475) |
|||
Basic and diluted net loss per common share |
$ (0.28) |
$ (0.25) |
$ (0.91) |
$ (0.74) |
|||
Shares used in computing basic and diluted net loss per common share |
46,365 |
45,319 |
45,701 |
45,306 |
|||
(1) Includes the following non-cash, stock-based compensation expense: |
|||||||
Cost of goods sold |
$ 80 |
$ 77 |
$ 243 |
$ 225 |
|||
Research and development |
458 |
560 |
1,442 |
1,746 |
|||
General and administrative |
480 |
441 |
1,555 |
1,437 |
|||
Total |
$ 1,018 |
$ 1,078 |
$ 3,240 |
$ 3,408 |
|||
(2) Interest income and other income (expense) includes $0.6 million and $0.4 million in non-cash charges for the three months ended September 30, 2017 and 2016, respectively, and $0.4 million in non-cash charges and $0.1 million in non-cash income for the nine months ended September 30, 2017 and 2016, respectively, related to warrants issued in connection with a private placement equity financing, completed in June 2012. |
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September 30, 2017 |
December 31, 2016 |
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Selected Balance Sheet Data |
|||||||
Cash and cash equivalents |
$ 67,936 |
$ 80,310 |
|||||
Total assets |
82,743 |
99,993 |
|||||
Total liabilities |
113,052 |
105,330 |
|||||
Total stockholders' deficit |
(30,309) |
(5,337) |
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SOURCE
Investors, Brian Korb, Trout Group LLC, 646-378-2923, investors@acelrx.com or Raffi Asadorian, Chief Financial Officer, AcelRx, investors@acelrx.com