AcelRx Pharmaceuticals Announces Commercial Launch of DSUVIA and Reports Fourth Quarter and Full Year 2018 Financial Results
AcelRx Pharmaceuticals Announces Commercial Launch of DSUVIA and Reports Fourth Quarter and Full Year 2018 Financial Results
"This past year was a tremendous success for the Company, highlighted by the
Fourth Quarter and Recent Highlights
- Following the positive recommendation from the
FDA advisory committee inOctober 2018 , theFDA approved DSUVIA inNovember 2018 for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. - AcelRx now has 14 Orange Book listed patents with exclusivity dates ranging from 2027 through 2031.
- The staged DSUVIA launch was initiated with fifteen hospital account managers hired, trained and placed in the field beginning in second half of
January 2019 . - Commercial launch of DSUVIA with initial contracted wholesaler orders received and shipped in the second half of February, as planned.
- Contracts executed with GPO targets covering approximately 80% of the hospital customers included in the DSUVIA initial launch markets.
Financial Information
- Cash, cash equivalents and short-term investments balance of
$105.7 million as ofDecember 31, 2018 ; - Combined R&D and G&A expenses for the fourth quarter 2018 totaled
$10.4 million compared to$7.6 million for the prior year period. Excluding stock-based compensation expense, these amounts were$9.2 million for the fourth quarter of 2018 compared to$6.6 million for the prior year period. The increase in R&D and G&A expenses is primarily due to increased personnel-related expenses in preparation for the commercial launch of DSUVIA. R&D and G&A expenses for the year endedDecember 31, 2018 totaled$33.9 million compared to$36.0 million in the year endedDecember 31, 2017 . Excluding stock-based compensation expense, these amounts were$29.1 million for 2018 compared to$32.0 million for the prior year. The decrease in R&D and G&A expenses is primarily due to lower Zalviso-related expenses attributed to the Phase 3 clinical program completed in 2017, partially offset by increased personnel-related expenses in preparation for the commercial launch of DSUVIA. 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; - Excluding
$53.4 million in net proceeds raised from the issuance of equity, the Company used$11.3 million in cash, including$2.3 million in debt service, during the quarter endedDecember 31, 2018 ; and - For the fourth quarter of 2018, net loss was
$12.6 million , or$0.18 per basic and diluted share, compared to$9.9 million , or$0.20 per basic and diluted share, for the fourth quarter of 2017. Net loss for the year endedDecember 31, 2018 was$47.1 million , or$0.81 basic and diluted net loss per share, compared to$51.5 million , or$1.10 basic and diluted net loss per share, for the prior year.
2019 Guidance
Based on the initial month of experience in the field with its commercial team, the Company is increasing its expected number of formulary approval wins by the end of 2019 to 125, up from the previous guidance of 100. In addition, the Company plans to accelerate the hiring of the next stage of 25 hospital account managers to the third quarter from the fourth quarter to better cover the initial indications of interest in DSUVIA by hospitals. Quarterly combined R&D and SG&A expense in 2019 is expected to range from
2019 financial guidance is based on the Company's current expectations and are forward-looking statements. Actual results could differ materially depending on market conditions and the factors set forth under "Safe Harbor Statement" below.
Conference Call and Webcast Information
As previously announced, AcelRx will conduct an investment-community conference call
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA™, known as DZUVEO™ outside
For more information, please visit www.DSUVIA.com.
About
For additional information about AcelRx, 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 anticipated commercial growth of DSUVIA in
Selected Financial Data |
|||||||
(in thousands, except per share data) |
|||||||
(unaudited) |
|||||||
Three Months Ended |
Twelve Months Ended |
||||||
December 31 |
December 31 |
||||||
2018 |
2017 |
2018 |
2017 |
||||
Statement of Comprehensive Loss Data |
|||||||
Revenue: |
|||||||
Collaboration agreement revenue |
$ 511 |
$ 699 |
$ 1,313 |
$ 7,143 |
|||
Contract and other revenue |
102 |
41 |
838 |
852 |
|||
Total revenue |
613 |
740 |
2,151 |
7,995 |
|||
Operating costs and expenses: |
|||||||
Cost of goods sold (1) |
1,238 |
962 |
3,976 |
10,659 |
|||
Research and development (1) |
2,704 |
3,676 |
13,137 |
19,409 |
|||
General and administrative (1) |
7,648 |
3,909 |
20,765 |
16,609 |
|||
Total operating costs and expenses |
11,590 |
8,547 |
37,878 |
46,677 |
|||
Loss from operations |
(10,977) |
(7,807) |
(35,727) |
(38,682) |
|||
Other (expense) income: |
|||||||
Interest expense |
(459) |
(720) |
(2,217) |
(3,316) |
|||
Interest income and other income (expense), net |
495 |
725 |
1,138 |
510 |
|||
Non-cash interest expense on liability related to sale of future royalties |
(1,617) |
(2,786) |
(10,341) |
(10,721) |
|||
Total other expense |
(1,581) |
(2,781) |
(11,420) |
(13,527) |
|||
(Benefit) provision for income taxes |
- |
(703) |
2 |
(701) |
|||
Net loss |
$ (12,558) |
$ (9,885) |
$ (47,149) |
$ (51,508) |
|||
Basic and diluted net loss per common share |
$ (0.18) |
$ (0.20) |
$ (0.81) |
$ (1.10) |
|||
Shares used in computing basic and diluted net loss per common share |
70,623 |
50,391 |
58,409 |
46,884 |
|||
(1) Includes the following non-cash, stock-based compensation expense: |
|||||||
Cost of goods sold |
$ 78 |
$ 80 |
$ 358 |
$ 324 |
|||
Research and development |
392 |
459 |
1,970 |
1,901 |
|||
General and administrative |
762 |
514 |
2,840 |
2,069 |
|||
Total |
$ 1,232 |
$ 1,053 |
$ 5,168 |
$ 4,294 |
|||
December 31, 2018 |
December 31, 2017 |
||||||
Selected Balance Sheet Data |
|||||||
Cash, cash equivalents and investments |
$ 105,715 |
$ 60,469 |
|||||
Total assets |
120,533 |
75,552 |
|||||
Total liabilities |
116,280 |
112,061 |
|||||
Total stockholders' equity (deficit) |
4,253 |
(36,509) |
Reconciliation of Non-GAAP Financial Measures |
|||||||
(Operating Expenses less associated stock-based compensation expense) |
|||||||
Three Months Ended |
Twelve Months Ended |
||||||
December 31 |
December 31 |
||||||
2018 |
2017 |
2018 |
2017 |
||||
Operating expenses (GAAP): |
|||||||
Research and development |
$ 2,704 |
$ 3,676 |
$ 13,137 |
$ 19,409 |
|||
General and administrative |
7,648 |
3,909 |
20,765 |
16,609 |
|||
Total operating expenses |
10,352 |
7,585 |
33,902 |
36,018 |
|||
Less associated stock-based |
|||||||
compensation expense |
1,154 |
973 |
4,810 |
3,970 |
|||
Operating expenses (non-GAAP) |
$ 9,198 |
$ 6,612 |
$ 29,092 |
$ 32,048 |
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SOURCE
Media Contacts: Theresa Dolge, Evoke, 215-928-2748, theresa.dolge@evokegroup.com or Jessica Ross, Evoke, 215-928-2346, jessica.ross@evokegroup.com, Investor Contacts: Raffi Asadorian, CFO, AcelRx, investors@acelrx.com or Brian Korb, Solebury Trout, 646-378-2923, investors@acelrx.com