News Release
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AcelRx Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results
"After only two quarters in 2019 with an expanded sales team, exceeding last year's formulary and REMS objectives is a solid indicator of the growing acceptance of DSUVIA® as a treatment option for the management of acute pain. We fully expect DSUVIA's success to continue and look forward to the
Fourth Quarter and Recent Highlights
- Announced an agreement to acquire Tetraphase Pharmaceuticals in a stock for stock transaction at an exchange ratio of 0.6303 shares of AcelRx for each share of Tetraphase, valuing Tetraphase at
$14.4 million as of the close of trading onMarch 13, 2020 . Also entered into a co-promotion agreement to immediately begin realizing commercial combination benefits prior to closing of the acquisition. - The Company is on track to achieve its previously communicated target of 465 REMS-certified facilities and formulary approvals by the end of 2020. As of
March 15, 2020 , 218 healthcare facilities are now REMS-certified and able to purchase DSUVIA and 223 formulary approvals have been achieved. - Confirmed timing for
April 2020 DSUVIA Milestone C meeting with theDepartment of Defense , with procurement recommendation expected post-meeting. - Announced an agreement with
Brigham and Women's Hospital for an investigator-initiated study led byRichard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of theCenter for Perioperative Research atBrigham and Women's Hospital andHarvard Medical School . The study plans to examine the perioperative use of DSUVIA in the analgesic regimen for spine surgery.
Financial Information
- Cash, cash equivalents and short-term investments balance of
$66.1 million as ofDecember 31, 2019 ; - Fourth quarter 2019 net revenues were
$0.5 million , and for the full year 2019 were$2.3 million , as previously announced; - Combined R&D and SG&A expenses for the fourth quarter of 2019 totaled
$13.8 million compared to$10.4 million for the fourth quarter of 2018. Excluding stock-based compensation expense, these amounts were$12.6 million for the fourth quarter of 2019 compared to$9.2 million for the fourth quarter of 2018. R&D and SG&A expenses for the year endedDecember 31, 2019 totaled$49.7 million compared to$33.9 million for the year endedDecember 31, 2018 . Excluding stock-based compensation expense, these figures were$44.9 million for the year endedDecember 31, 2019 compared to$29.1 million for the year endedDecember 31, 2018 . The increase in combined R&D and SG&A expenses is primarily due to increased personnel-related expenses 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; - Net cash outflow for the fourth quarter of 2019 was
$14.3 million , including$0.6 million in debt service, and for the year-endedDecember 31, 2019 was$39.6 million , and; - For the fourth quarter of 2019, net loss was
$14.4 million , or$0.18 per basic and diluted share, compared to$12.6 million , or$0.18 per basic and diluted share, for the fourth quarter of 2018. Net loss for the year endedDecember 31, 2019 was$53.2 million , or$0.67 per basic and diluted share, compared to$47.1 million , or$0.81 per basic and diluted share, for the year endedDecember 31, 2018 .
2020 Guidance
As previously announced, the Company's year-end goals include obtaining 465 REMS-certified facilities and 465 formulary approvals in 2020. Quarterly combined R&D and SG&A expense in 2020 is expected to range from
2020 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 the "Forward-Looking Statements" heading below.
Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO™ in
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
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the number of REMS-certified facilities and formulary approvals expected by the end of 2020, the timing of the
Selected Financial Data |
|||||||
(in thousands, except per share data) |
|||||||
(unaudited) |
|||||||
Three Months Ended |
Twelve Months Ended |
||||||
|
December 31 |
||||||
2019 |
2018 |
2019 |
2018 |
||||
Statement of Comprehensive Loss Data |
|||||||
Revenue: |
|||||||
Product sales |
$ 377 |
$ 390 |
$ 1,830 |
$ 825 |
|||
Contract and other collaboration |
98 |
223 |
459 |
1,326 |
|||
Total revenue |
475 |
613 |
2,289 |
2,151 |
|||
Operating costs and expenses: |
|||||||
Cost of goods sold (1) |
1,618 |
1,238 |
6,806 |
3,976 |
|||
Research and development (1) |
1,063 |
2,704 |
4,661 |
13,137 |
|||
Selling, general and administrative (1) |
12,786 |
7,648 |
45,027 |
20,765 |
|||
Total operating costs and expenses |
15,467 |
11,590 |
56,494 |
37,878 |
|||
Loss from operations |
(14,992) |
(10,977) |
(54,205) |
(35,727) |
|||
Other income (expense): |
|||||||
Interest expense |
(831) |
(459) |
(2,535) |
(2,217) |
|||
Interest income and other income (expense), net |
438 |
495 |
2,166 |
1,138 |
|||
Non-cash interest income (expense) on liability related to sale of future royalties |
962 |
(1,617) |
1,337 |
(10,341) |
|||
Total other income (expense) |
569 |
(1,581) |
968 |
(11,420) |
|||
Provision for income taxes |
- |
- |
(3) |
(2) |
|||
Net loss |
$ (14,423) |
$ (12,558) |
$ (53,240) |
$ (47,149) |
|||
Basic and diluted net loss per common share |
$ (0.18) |
$ (0.18) |
$ (0.67) |
$ (0.81) |
|||
Shares used in computing basic and diluted net loss per common share |
79,573 |
70,623 |
79,184 |
58,409 |
|||
(1) Includes the following non-cash, stock-based compensation expense: |
|||||||
Cost of goods sold |
$ 63 |
$ 78 |
$ 260 |
$ 358 |
|||
Research and development |
221 |
392 |
920 |
1,970 |
|||
Selling, general and administrative |
994 |
762 |
3,877 |
2,840 |
|||
Total |
$ 1,278 |
$ 1,232 |
$ 5,057 |
$ 5,168 |
|||
|
|
||||||
Selected Balance Sheet Data |
|||||||
Cash, cash equivalents and investments |
$ 66,137 |
$ 105,715 |
|||||
Total assets |
91,356 |
120,533 |
|||||
Total liabilities |
132,774 |
116,280 |
|||||
Total stockholders' (deficit) equity |
(41,418) |
4,253 |
Reconciliation of Non-GAAP Financial Measures |
|||||||
(Operating Expenses less associated stock-based compensation expense) |
|||||||
Three Months Ended |
Twelve Months Ended |
||||||
|
|
||||||
2019 |
2018 |
2019 |
2018 |
||||
Operating expenses (GAAP): |
|||||||
Research and development |
$ 1,063 |
$ 2,704 |
$ 4,661 |
$ 13,137 |
|||
Selling, general and administrative |
12,786 |
7,648 |
45,027 |
20,765 |
|||
Total operating expenses |
13,849 |
10,352 |
49,688 |
33,902 |
|||
Less associated stock-based compensation expense |
1,215 |
1,154 |
4,797 |
4,810 |
|||
Operating expenses (non-GAAP) |
$ 12,634 |
$ 9,198 |
$ 44,891 |
$ 29,092 |
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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; or Investor Contacts: Raffi Asadorian, CFO, AcelRx, investors@acelrx.com; or Brian Korb, Solebury Trout, 646-378-2923, investors@acelrx.com