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AcelRx Pharmaceuticals Reports First Quarter 2019 Financial Results
"I am very pleased with the progress made in the first five weeks of the DSUVIA™ launch. Shifting the paradigm in healthcare facilities to a new, non-invasive treatment option for acute pain will take time; however, from my time in the field, I have seen first-hand the enthusiasm that healthcare professionals have for DSUVIA," said
First Quarter and Recent Highlights
- Launched DSUVIA in the second-half of
February 2019 using 15 hospital account managers, with DSUVIA available for sale for five weeks in the first quarter of 2019 - Successfully completed or scheduled 46 hospital formulary reviews by mid-year, on track for 125 approvals by year-end
- In addition to hospital formularies, AcelRx became an approved vendor for an ambulatory surgical center network with over 300 locations across the U.S., making DSUVIA available beyond the hospital setting
- Pooled safety data from 804 patients was published in Pain Management demonstrating sufentanil sublingual tablets are well-tolerated in a wide variety of postoperative and emergency room patients
Financial Information
- Cash, cash equivalents and short-term investments balance of
$90.2 million as ofMarch 31, 2019 ; - Combined R&D and SG&A expenses for the first quarter of 2019 totaled
$11.4 million compared to$7.5 million for the first quarter of 2018. Excluding stock-based compensation expense, these amounts were$10.3 million for the first quarter of 2019 compared to$6.5 million for the first quarter 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 first quarter of 2019 was
$15.5 million which included$2.3 million in debt service; and - For the first quarter of 2019, net loss was
$13.7 million , or$0.17 per basic and diluted share, compared to$11.6 million , or$0.23 per basic and diluted share, for the first quarter of 2018.
2019 Guidance
AcelRx remains on track to achieve 125 hospital formulary approvals by the end of 2019. The acceleration of the second phase of hiring 25 additional hospital account managers to the beginning of the third quarter from the fourth quarter also remains as planned. Quarterly combined R&D and SG&A expense for the remaining quarters of 2019 is expected to remain in the range of
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 the safe harbor statements 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 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, and market demand for, DSUVIA in
Selected Financial Data |
|||
(in thousands, except per share data) |
|||
(unaudited) |
|||
Three Months Ended |
|||
March 31 |
|||
2019 |
2018 |
||
Statement of Comprehensive Loss Data |
|||
Revenue: |
|||
Net product sales |
$ 47 |
$ - |
|
Collaboration agreement |
218 |
274 |
|
Contract and other |
- |
69 |
|
Total revenue |
265 |
343 |
|
Operating costs and expenses: |
|||
Cost of goods sold (1) |
1,230 |
1,114 |
|
Research and development (1) |
1,377 |
3,513 |
|
Selling, general and administrative (1) |
9,976 |
3,985 |
|
Total operating costs and expenses |
12,583 |
8,612 |
|
Loss from operations |
(12,318) |
(8,269) |
|
Other (expense) income: |
|||
Interest expense |
(376) |
(643) |
|
Interest income and other income (expense), net |
627 |
136 |
|
Non-cash interest expense on liability related to sale of future royalties |
(1,607) |
(2,816) |
|
Total other expense |
(1,356) |
(3,323) |
|
Net loss |
$ (13,674) |
$ (11,592) |
|
Basic and diluted net loss per common share |
$ (0.17) |
$ (0.23) |
|
Shares used in computing basic and diluted net loss per common share |
78,789 |
50,931 |
|
(1) Includes the following non-cash, stock-based compensation expense: |
|||
Cost of goods sold |
$ 61 |
$ 87 |
|
Research and development |
224 |
432 |
|
Selling, general and administrative |
822 |
561 |
|
Total |
$ 1,107 |
$ 1,080 |
|
March 31, 2019 |
December 31, 2018 |
||
Selected Balance Sheet Data |
|||
Cash, cash equivalents and investments |
$ 90,150 |
$ 105,715 |
|
Total assets |
113,444 |
120,533 |
|
Total liabilities |
121,335 |
116,280 |
|
Total stockholders' (deficit) equity |
(7,891) |
4,253 |
Reconciliation of Non-GAAP Financial Measures |
|||
(Operating Expenses less associated stock-based compensation expense) |
|||
Three Months Ended |
|||
March 31 |
|||
2019 |
2018 |
||
Operating expenses (GAAP): |
|||
Research and development |
$ 1,377 |
$ 3,513 |
|
Selling, general and administrative |
9,976 |
3,985 |
|
Total operating expenses |
11,353 |
7,498 |
|
Less associated stock-based |
|||
compensation expense |
1,046 |
993 |
|
Operating expenses (non-GAAP) |
$ 10,307 |
$ 6,505 |
|
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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