News Release
View printer-friendly version << Back
AcelRx Pharmaceuticals Reports Third Quarter 2020 Financial Results
"The third quarter represented one of our most active and successful quarters since DSUVIA's approval," said
Third Quarter Highlights
- In July, AcelRx entered into a distribution agreement with Zimmer Biomet to market DSUVIA within the dental and oral surgery markets in
the United States exclusively through Zimmer Biomet's Dental division, expandingU.S. availability of DSUVIA. It is estimated that the applicable market in dental surgeries is over 7 million annual procedures. - In July, AcelRx completed a
$10 million common stock offering priced at the market with two leading life science investors. - In August, AcelRx announced the publication of a study entitled "Reduced Opioid Use and Reduced Time in the
Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting," byChristian Tvetenstrand , MD andMichael Wolff , MD, in theJournal of Clinical Anesthesia andPain Management . Highlights of the publication included a greater than 50% overall reduction in opioids administered perioperatively and a 34% reduction in PACU time in the DSUVIA-treated patients compared to historical controls. - In August, AcelRx announced an investigator-initiated study with
Cleveland Clinic that will assess the effects of DSUVIA on post-operative recovery from orthopedic surgery. - In September, AcelRx announced that the
U.S. military's access to DSUVIA had been expanded with the addition of DSUVIA to theDepartment of Defense Joint Deployment Formulary (JDF). - In September, the
U.S. Army awarded AcelRx with an initial contract of up to$3.6 million over four years for the purchase of DSUVIA to support aDoD study to aid the development of clinical practice guidelines.
Financial Information
- Cash, cash equivalents and short-term investments balance was
$43.0 million as ofSeptember 30, 2020 . - Net revenues for the third quarter 2020 were
$1.4 million , of which approximately$1.3 million relates to product sales (compared to$0.3 million in product sales for the second quarter of 2020). - Combined R&D and SG&A expenses for the third quarter of 2020 totaled
$8.6 million , a significant reduction compared to$12.0 million for the third quarter of 2019. Excluding stock-based compensation expense, these amounts were$7.5 million for the third quarter of 2020 compared to$10.7 million for the third quarter of 2019. The decrease in combined R&D and SG&A expenses in the third quarter of 2020 was primarily due to a reduction of$1.8 million in personnel costs and a$1.1 million reduction in DSUVIA-related commercialization expenses. - Net loss for the third quarter of 2020 was
$8.9 million , or$0.10 per basic and diluted share, compared to$12.7 million , or$0.16 per basic and diluted share, for the third quarter of 2019.
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
This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, 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 and Cautionary Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the timing and size of military orders, the market for DSUVIA in dental and oral surgeries, the expected commencement of an investigator-initiated study and the scope of the study. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that the military and hospital systems delay, or fail to place, orders, that AcelRx may not experience the expected benefits from the Zimmer Biomet commercial opportunity and the uncertainties inherent in the initiation, execution and completion of investigator-initiated studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the
Limitations of the published study referenced above include that it was an open-label study, the retrospective nature of the control group, and the focus on only general surgery patients.
Selected Financial Data |
|||||||
(in thousands, except per share data) |
|||||||
(unaudited) |
|||||||
Three Months Ended |
Nine Months Ended |
||||||
|
September 30 |
||||||
2020 |
2019 |
2020 |
2019 |
||||
Statement of Comprehensive Loss Data |
|||||||
Revenue: |
|||||||
Product sales |
$ 1,287 |
$ 559 |
$ 1,864 |
$ 1,453 |
|||
Contract and other collaboration |
81 |
49 |
2,814 |
361 |
|||
Total revenue |
1,368 |
608 |
4,678 |
1,814 |
|||
Operating costs and expenses: |
|||||||
Cost of goods sold (1) |
1,851 |
2,148 |
4,732 |
5,188 |
|||
Research and development (1) |
956 |
1,058 |
3,181 |
3,598 |
|||
Selling, general and administrative (1) |
7,598 |
10,936 |
28,484 |
32,241 |
|||
Total operating costs and expenses |
10,405 |
14,142 |
36,397 |
41,027 |
|||
Loss from operations |
(9,037) |
(13,534) |
(31,719) |
(39,213) |
|||
Other income (expense): |
|||||||
Interest expense |
(824) |
(828) |
(2,551) |
(1,704) |
|||
Interest income and other income (expense), net |
106 |
645 |
311 |
1,728 |
|||
Non-cash interest income (expense) on liability related to sale of future royalties |
825 |
986 |
2,502 |
375 |
|||
Total other income (expense) |
107 |
803 |
262 |
399 |
|||
Provision for income taxes |
- |
- |
(4) |
(3) |
|||
Net loss |
$ (8,930) |
$ (12,731) |
|
|
|||
Basic and diluted net loss per common share |
$ (0.10) |
$ (0.16) |
$ (0.38) |
$ (0.49) |
|||
Shares used in computing basic and diluted net loss per common share |
87,913 |
79,461 |
82,896 |
79,053 |
|||
(1) Includes the following non-cash, stock-based compensation expense: |
|||||||
Cost of goods sold |
$ 25 |
$ 68 |
$ 98 |
$ 197 |
|||
Research and development |
188 |
242 |
572 |
699 |
|||
Selling, general and administrative |
891 |
1,016 |
2,670 |
2,883 |
|||
Total |
$ 1,104 |
$ 1,326 |
$ 3,340 |
$ 3,779 |
|||
|
|
||||||
Selected Balance Sheet Data |
|||||||
Cash, cash equivalents and investments |
$ 43,023 |
$ 66,137 |
|||||
Total assets |
66,179 |
91,356 |
|||||
Total liabilities |
124,032 |
132,774 |
|||||
Total stockholders' (deficit) equity |
(57,853) |
(41,418) |
|||||
Reconciliation of Non-GAAP Financial Measures |
|||||||
(Operating Expenses less associated stock-based compensation expense) |
|||||||
Three Months Ended |
Nine Months Ended |
||||||
|
|
||||||
2020 |
2019 |
2020 |
2019 |
||||
Operating expenses (GAAP): |
|||||||
Research and development |
$ 956 |
$ 1,058 |
$ 3,181 |
$ 3,598 |
|||
Selling, general and administrative |
7,598 |
10,936 |
28,484 |
32,241 |
|||
Total operating expenses |
8,554 |
11,994 |
31,665 |
35,839 |
|||
Less associated stock-based compensation expense |
1,079 |
1,258 |
3,242 |
3,582 |
|||
Operating expenses (non-GAAP) |
|
|
|
|
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-reports-third-quarter-2020-financial-results-301167437.html
SOURCE
Media, Evoke, Theresa Dolge / Jessica Ross, 215-928-2748 / 215-928-2346, theresa.dolge@evokegroup.com / jessica.ross@evokegroup.com; or Investors, Raffi Asadorian, CFO AcelRx, investors@acelrx.com; or Brian Korb, Solebury Trout, 646-378-2923, Investors@acelrx.com