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AcelRx Pharmaceuticals Reports First Quarter 2018 Financial Results
"The first quarter of this year was extremely productive as we successfully advanced DSUVIA down the path for
Q1 and Recent Highlights
- Constructive Type A
FDA meeting held in January clarifying DSUVIA path to resubmission; - Successfully completed the Human Factors study performed to validate the effectiveness of the revised DSUVIA Directions For Use (DFU);
- Completed preparation and resubmission of the DSUVIA NDA addressing the comments received from the
FDA in theOctober 2017 Complete Response Letter; and - Received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP) for DZUVEO recommending approval in theEuropean Union and European Economic Area for the management of moderate-to-severe acute pain in medically monitored settings.
Financial Information
March 31, 2018 cash and short-term investment balance of$51.2 million ;- R&D and G&A expenses for the quarter ended
March 31, 2018 totaled$7.5 million compared to$11.1 million for the prior year period. Excluding stock-based compensation expense, these figures were$6.5 million for the first quarter of 2018 compared to$10.0 million for the prior year period. This decrease is primarily due to lower Zalviso-related expenses attributed to the Phase 3 clinical program completed in 2017. 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 usage during the first quarter 2018 of
$9.3 million included$2.3 million of debt service; and - For the first quarter of 2018 net loss was
$11.6 million , or$0.23 per basic and diluted share, compared to$15.6 million , or$0.34 per basic and diluted share, for the first quarter of 2017.
2018 Remaining Milestones
- Expected acceptance of DSUVIA NDA by
FDA in Q2 2018; Potential European Commission approval of DZUVEO in Q3 2018;- Expected
FDA advisory committee meeting for DSUVIA in Q3 2018; - Anticipated Prescription Drug User Fee Act, PDUFA, date for DSUVIA in Q4 2018; and
- Anticipated resubmission of NDA for Zalviso in H2 2018.
Conference Call and Webcast Information
As previously announced, AcelRx will conduct an investment-community conference call today,
About
For additional information about AcelRx's clinical programs, 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 the process and timing of anticipated future development of AcelRx's product candidates, DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ outside
Selected Financial Data |
||||
(in thousands, except per share data) |
||||
(unaudited) |
||||
Three Months Ended |
||||
March 31, |
||||
2018 |
2017 |
|||
Statement of Comprehensive Loss Data |
||||
Revenue: |
||||
Collaboration agreement revenue |
$ 274 |
$ 3,027 |
||
Contract and other revenue |
69 |
82 |
||
Total revenue |
343 |
3,109 |
||
Operating costs and expenses: |
||||
Cost of goods sold (1) |
1,114 |
4,125 |
||
Research and development (1) |
3,513 |
6,919 |
||
General and administrative (1) |
3,985 |
4,138 |
||
Total operating costs and expenses |
8,612 |
15,182 |
||
Loss from operations |
(8,269) |
(12,073) |
||
Other (expense) income: |
||||
Interest expense |
(643) |
(774) |
||
Interest income and other income (expense), net |
136 |
(146) |
||
Non-cash interest expense on liability related to sale of future royalties |
(2,816) |
(2,558) |
||
Total other expense |
(3,323) |
(3,478) |
||
Benefit (provision) for income taxes |
- |
- |
||
Net loss |
$ (11,592) |
$ (15,551) |
||
Basic and diluted net loss per common share |
$ (0.23) |
$ (0.34) |
||
Shares used in computing basic and diluted net loss per common share |
50,931 |
45,348 |
||
(1) Includes the following non-cash, stock-based compensation expense: |
||||
Cost of goods sold |
$ 87 |
$ 84 |
||
Research and development |
432 |
537 |
||
General and administrative |
561 |
523 |
||
Total |
$ 1,080 |
$ 1,144 |
||
March 31, 2018 |
December 31, 2017 |
|||
Selected Balance Sheet Data |
||||
Cash, cash equivalents and investments |
$ 51,176 |
$ 60,469 |
||
Total assets |
65,813 |
75,552 |
||
Total liabilities |
112,693 |
112,061 |
||
Total stockholders' deficit |
(46,880) |
(36,509) |
Reconciliation of Non-GAAP Financial Measures |
|||
(Operating Expenses less associated stock-based compensation expense) |
|||
Three Months Ended |
|||
March 31, |
|||
2018 |
2017 |
||
Operating expenses (GAAP): |
|||
Research and development |
$ 3,513 |
$ 6,919 |
|
General and administrative |
3,985 |
4,138 |
|
Total operating expenses |
7,498 |
11,057 |
|
Less associated stock-based |
|||
compensation expense |
993 |
1,060 |
|
Operating expenses (non-GAAP) |
$ 6,505 |
$ 9,997 |
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SOURCE
Investors, Brian Korb, Solebury Trout, 646-378-2923, investors@acelrx.com, or Raffi Asadorian, Chief Financial Officer, AcelRx, investors@acelrx.com