AcelRx Pharmaceuticals Reports Third Quarter 2019 Financial Results
AcelRx Pharmaceuticals Reports Third Quarter 2019 Financial Results
"Achieving 125 REMS-certified facilities two months ahead of our year-end goal demonstrates healthcare providers' increasing interest in DSUVIA," said
Third Quarter and Recent Highlights
- 130 healthcare facilities are now REMS-certified and able to purchase DSUVIA and 105 formulary approvals have been achieved through
October 31, 2019 ; approximately 60% of REMS certifications and formulary approvals have occurred since the date of the Company's last earnings call - AcelRx was selected to present at one of the two plenary sessions of the 2019 Military Health System Research Symposium; the presentation was entitled "Pooled Safety Analysis of Patients Who Were Exposed to < 300 mcg vs. ≥300 mcg of Sublingual Sufentanil in a 24 Hour Period for Treatment of Acute Pain"
- Pooled dosing and efficacy data from use of the sufentanil sublingual tablet (SST) 30 mcg among multiple demographic subgroups (age, sex, race, and body mass index) was accepted for publication in the
Journal of PeriAnesthesia Nursing to aid nurses in understanding the effectiveness and duration of action of SST 30 mcg in the management of moderate-to-severe acute pain across a variety of patient demographics
Financial Information
- Cash, cash equivalents and short-term investments balance of
$80.4 million as ofSeptember 30, 2019 ; - Combined R&D and SG&A expenses for the third quarter of 2019 totaled
$12.0 million compared to$8.8 million for the third quarter of 2018. Excluding stock-based compensation expense, these amounts were$10.7 million for the third quarter of 2019 compared to$7.1 million for the third quarter of 2018. R&D and SG&A expenses for the first nine months of 2019 totaled$35.8 million compared to$23.6 million in the first nine months of 2018. Excluding stock-based compensation expense, these figures were$32.3 million for the first nine months of 2019 compared to$19.9 million for the first nine months of 2018. The increase in 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 third quarter of 2019 was
$11.1 million , which included$0.6 million in debt service; - For the third quarter of 2019, net loss was
$12.7 million , or$0.16 per basic and diluted share, compared to$12.5 million , or$0.21 per basic and diluted share, for the third quarter of 2018. Net loss for the first nine months of 2019 was$38.8 million , or$0.49 per basic and diluted share, compared to$34.6 million , or$0.64 per basic and diluted share, for the prior year period.
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 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 these non-GAAP financial measures provide useful supplementary information to, and facilitate additional analysis by, investors and analysts. In particular, the Company believes that these non-GAAP financial measures, 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, these types of non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. AcelRx's management also regularly uses these non-GAAP financial measures 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 condensed 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 formulary approvals and use of DSUVIA. 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. 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 the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the
Selected Financial Data |
|||||
(in thousands, except per share data) |
|||||
(unaudited) |
|||||
Three Months Ended |
Nine Months Ended |
||||
September 30 |
September 30 |
||||
2019 |
2018 |
2019 |
2018 |
||
Net product sales |
$ 116 |
$ - |
$ 218 |
$ - |
|
Collaboration agreement |
492 |
177 |
$ 1,596 |
$ 802 |
|
Contract and other |
- |
200 |
- |
736 |
|
Total revenue |
608 |
377 |
1,814 |
1,538 |
|
Operating costs and expenses: |
|||||
Cost of goods sold |
2,148 |
875 |
5,188 |
2,738 |
|
Research and development |
1,058 |
3,642 |
3,598 |
10,433 |
|
General and administrative |
10,936 |
5,188 |
32,241 |
13,117 |
|
Total operating costs and expenses |
14,142 |
9,705 |
41,027 |
26,288 |
|
Loss from operations |
(13,534) |
(9,328) |
(39,213) |
(24,750) |
|
Other income (expense): |
|||||
Interest expense |
(828) |
(529) |
(1,704) |
(1,758) |
|
Interest income and other income (expense), net |
645 |
312 |
1,728 |
643 |
|
Non-cash interest income (expense) on liability related to sale of future royalties |
986 |
(2,913) |
375 |
(8,724) |
|
Total other income (expense) |
803 |
(3,130) |
399 |
(9,839) |
|
Provision for income taxes |
- |
- |
(3) |
(2) |
|
Net loss |
$ (12,731) |
$(12,458) |
$(38,817) |
$(34,591) |
|
Basic and diluted net loss per common share |
$ (0.16) |
$ (0.21) |
$ (0.49) |
$ (0.64) |
|
Shares used in computing basic and diluted net loss per common share |
79,461 |
60,004 |
79,053 |
54,292 |
|
(1) Includes the following non-cash, stock-based compensation expense: |
|||||
Cost of goods sold |
$ 68 |
$ 119 |
$ 197 |
$ 280 |
|
Research and development |
242 |
769 |
699 |
1,578 |
|
Selling, general and administrative |
1,016 |
920 |
2,883 |
2,078 |
|
Total |
$ 1,326 |
$ 1,808 |
$ 3,779 |
$ 3,936 |
|
September 30, 2019 |
December 31, 2018 |
||||
Selected Balance Sheet Data |
|||||
Cash, cash equivalents and investments |
$ 80,400 |
$ 105,715 |
|||
Total assets |
104,978 |
120,533 |
|||
Total liabilities |
133,252 |
116,280 |
|||
Total stockholders' (deficit) equity |
(28,274) |
4,253 |
Reconciliation of Non-GAAP Financial Measures |
|||||||
(Operating Expenses less associated stock-based compensation expense) |
|||||||
Three Months Ended |
Nine Months Ended |
||||||
September 30 |
September 30 |
||||||
2019 |
2018 |
2019 |
2018 |
||||
Operating expenses (GAAP): |
|||||||
Research and development |
$ 1,058 |
$ 3,642 |
$ 3,598 |
$ 10,433 |
|||
Selling, general and administrative |
10,936 |
5,188 |
32,241 |
13,117 |
|||
Total operating expenses |
11,994 |
8,830 |
35,839 |
23,550 |
|||
Less associated stock-based compensation expense |
1,258 |
1,689 |
3,582 |
3,656 |
|||
Operating expenses (non-GAAP) |
$ 10,736 |
$ 7,141 |
$ 32,257 |
$ 19,894 |
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-reports-third-quarter-2019-financial-results-300953234.html
SOURCE
Media Contacts: Theresa Dolge, Evoke, 215-928-2748, theresa.dolge@evokegroup.com, Jessica Ross, Evoke, 215-928-2346, jessica.ross@evokegroup.com, Investor Contacts: Raffi Asadorian, CFO, AcelRx, investors@acelrx.com, Brian Korb, Solebury Trout, 646-378-2923, investors@acelrx.com