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AcelRx Pharmaceuticals Reports Fourth Quarter 2017 Financial Results
"As disclosed earlier today, we had a constructive meeting with the
Recent Highlights
- The Type A
FDA meeting onJanuary 26, 2018 focused on addressing the two primary points in theOctober 2017 Complete Response Letter (CRL) regarding the DSUVIA New Drug Application (NDA). Official meeting minutes fromFDA indicate proposals discussed in the Type A meeting were reasonable, which provides a path to resubmit the DSUVIA NDA in the second quarter of 2018. - Completed preparation of Zalviso® NDA resubmission inclusive of positive IAP 312 study results on device functionality and tablet dispensing errors. However, AcelRx intends to hold resubmission until the second half of 2018 to focus on DSUVIA.
Financial Information
December 31, 2017 cash and short-term investment balance of$60.5 million .- Revenues of
$8.0 million for the full year 2017, consisting of$7.1 million from the Grunenthal collaboration agreement, and$0.9 million for work performed under theDepartment of Defense (DoD) contract for DSUVIA. In contrast, revenues from those two agreements for the full year 2016 were$6.4 million and$10.9 million , respectively. The year-over-year decrease in DoD contract revenue reflects our completion in 2016 of the Phase 3 clinical program for DSUVIA, which was reimbursed under the contract. - R&D and G&A expenses for the year ended
December 31, 2017 totaled$36.0 million , and excluding stock-based compensation was$32.0 million , compared to$37.0 million , and excluding stock-based compensation,$32.8 million , for the year endedDecember 31, 2016 . This decrease is due to lower DSUVIA-related expenses resulting from the completion of the Phase 3 clinical program in 2016, offset by an increase in Zalviso-related expenses attributed to the Phase 3 clinical program completed in 2017, and a small increase in pre-commercialization expenses in anticipation of potentialFDA approval of DSUVIA. For the quarter endedDecember 31, 2017 , R&D and G&A expenses totaled$7.6 million , and excluding stock-based compensation was$6.6 million , declining$2.8 million compared to the fourth quarter of 2016. The decrease was mainly due to lower DSUVIA-related expenses, which included the filing fee for the DSUVIA NDA during the fourth quarter of 2016. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures. - For full year 2017, net loss was
$51.5 million , or$1.10 basic and diluted net loss per share, compared to$43.2 million , or$0.95 basic and diluted net loss per share, for full year 2016. Net loss for the fourth quarter of 2017 was$9.9 million , or$0.20 basic and diluted net loss per share, compared to$9.7 million , or$0.21 basic and diluted net loss per share, for the fourth quarter of 2016. - Net cash usage during the fourth quarter 2017 of
$7.5 million included$4.0 million of debt service, inclusive of the payment of a$1.7 million deferred fee.
2018 Guidance and Expected Upcoming Milestones
AcelRx expects quarterly net cash usage in 2018 to remain in the
- Anticipated resubmission of NDA for DSUVIA in Q2 2018.
- Expected opinion on the Marketing Authorization Application (MAA) for DZUVEO from the
Committee for Medicinal Products for Human Use (CHMP) in H1 2018. - Expected
FDA advisory committee meeting for DSUVIA in Q3 2018. - Anticipated PDUFA date for DSUVIA in Q4 2018.
- Anticipated resubmission of NDA for Zalviso in H2 2018.
Conference Call and Webcast Information
As previously announced, AcelRx will conduct an investment-community conference call today,
About
For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
Non-GAAP Financial Measures
To supplement AcelRx's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non-GAAP financial measures in this press release, in particular, excluding stock-based compensation expense from its operating expenses. The company believes that this non-GAAP financial measure provides useful supplementary information to, and facilitates additional analysis by, investors and analysts. In particular, the company believes that this non-GAAP financial measure, when considered together with the company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the company's results from period to period and to its forward-looking guidance. In addition, this type of non-GAAP financial measure is regularly used by investors and analysts to model and track the company's financial performance. AcelRx's management also regularly uses this non-GAAP financial measure internally to understand, manage and evaluate the company's business and to make operating decisions. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with AcelRx's consolidated financial statements prepared in accordance with GAAP. The non-GAAP financial measures in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
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 DZUVEO outside
Selected Financial Data |
|||||||
(in thousands, except per share data) |
|||||||
(unaudited) |
|||||||
Three Months Ended |
Twelve Months Ended |
||||||
December 31 |
December 31 |
||||||
2017 |
2016 |
2017 |
2016 |
||||
Statement of Comprehensive Loss Data |
|||||||
Revenue: |
|||||||
Collaboration agreement revenue |
$ 699 |
$ 1,771 |
$ 7,143 |
$ 6,440 |
|||
Contract and other revenue |
41 |
4,664 |
852 |
10,917 |
|||
Total revenue |
740 |
6,435 |
7,995 |
17,357 |
|||
Operating costs and expenses: |
|||||||
Cost of goods sold (1) |
962 |
3,161 |
10,659 |
12,315 |
|||
Research and development (1) |
3,676 |
6,334 |
19,409 |
21,402 |
|||
General and administrative (1) |
3,909 |
4,078 |
16,609 |
15,597 |
|||
Total operating costs and expenses |
8,547 |
13,573 |
46,677 |
49,314 |
|||
Loss from operations |
(7,807) |
(7,138) |
(38,682) |
(31,957) |
|||
Other (expense) income: |
|||||||
Interest expense |
(720) |
(701) |
(3,316) |
(2,770) |
|||
Interest income and other income (expense), net(2) |
725 |
618 |
510 |
918 |
|||
Non-cash interest expense on liability related to sale of future royalties |
(2,786) |
(2,461) |
(10,721) |
(9,382) |
|||
Total other expense |
(2,781) |
(2,544) |
(13,527) |
(11,234) |
|||
Benefit (provision) for income taxes |
703 |
- |
701 |
34 |
|||
Net loss |
$ (9,885) |
$ (9,682) |
$(51,508) |
$(43,157) |
|||
Basic and diluted net loss per common share |
$ (0.20) |
$ (0.21) |
$ (1.10) |
$ (0.95) |
|||
Shares used in computing basic and diluted net loss per common share |
50,391 |
45,334 |
46,884 |
45,313 |
|||
(1) Includes the following non-cash, stock-based compensation expense: |
|||||||
Cost of goods sold |
$ 80 |
$ 77 |
$ 324 |
$ 302 |
|||
Research and development |
459 |
562 |
1,901 |
2,308 |
|||
General and administrative |
514 |
432 |
2,069 |
1,869 |
|||
Total |
$ 1,053 |
$ 1,071 |
$ 4,294 |
$ 4,479 |
|||
(2) Interest income and other income (expense) includes $0.6 million and $0.5 million in non-cash income for the three months ended December 31, 2017 and 2016, respectively, and $0.3 million and $0.6 million in non-cash income for the twelve months ended December 31, 2017 and 2016, respectively, related to warrants issued in connection with a private placement equity financing, completed in June 2012. These warrants expired in November 2017. |
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December 31, 2017 |
December 31, 2016 |
||||||
Selected Balance Sheet Data |
|||||||
Cash, cash equivalents and investments |
$ 60,469 |
$ 80,310 |
|||||
Total assets |
75,552 |
99,993 |
|||||
Total liabilities |
112,061 |
105,330 |
|||||
Total stockholders' deficit |
(36,509) |
(5,337) |
Reconciliation of Non-GAAP Financial Measures |
|||||
(Operating Expenses less associated stock-based compensation expense) |
|||||
Three Months Ended |
Three Months Ended |
Twelve Months Ended |
|||
2017 |
2016 |
2017 |
2017 |
2016 |
|
Operating expenses (GAAP): |
|||||
Research and development |
$ 3,676 |
$ 6,334 |
$ 3,913 |
$ 19,409 |
$ 21,402 |
General and administrative |
3,909 |
4,078 |
4,406 |
16,609 |
15,597 |
Total operating expenses |
7,585 |
10,412 |
8,319 |
36,018 |
36,999 |
Less associated stock-basedcompensation expense |
973 |
994 |
938 |
3,970 |
4,177 |
Operating expenses (non-GAAP) |
$ 6,612 |
$ 9,418 |
$ 7,381 |
$ 32,048 |
$ 32,822 |
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SOURCE
Investors: Brian Korb, Trout Group LLC, 646-378-2923, investors@acelrx.com, Raffi Asadorian, Chief Financial Officer, AcelRx, investors@acelrx.com