Investors

REDWOOD CITY, Calif., May 9, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today reported its first quarter 2018 financial results.

"The first quarter of this year was extremely productive as we successfully advanced DSUVIA down the path for FDA approval with our recent NDA resubmission for DSUVIA. We also received a CHMP positive opinion for DZUVEO™ in Europe," said Vince Angotti, Chief Executive Officer of AcelRx. "We've achieved each of the milestones outlined on our year-end earnings call.  Our goal is to end the year with another approved product in Europe and our first approved product in the U.S. with DSUVIA," continued Angotti.

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 the October 2017 Complete Response Letter; and
• Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for DZUVEO recommending approval in the European 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, May 9, 2018 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to a webcast of the conference call live via the Internet may do so by visiting the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be archived on the AcelRx website for 90 days following the call.

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The company has two product candidates including DSUVIA^™ (sufentanil sublingual tablet, 30 mcg), known as DZUVEO^™ outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, and Zalviso^® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings.

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 the United States, and Zalviso^® (sufentanil sublingual tablet system), including the acceptance of the NDA resubmission for DSUVIA by the FDA and related expected PDUFA date; the timing and results of the European Commission (EC) final decision on the Marketing Authorization Application (MAA) for DZUVEO, the anticipated resubmission of the Zalviso NDA, and the Company's anticipated conservation of cash in expectation of a potential commercial launch of DSUVIA, if approved. These forward-looking statements are based on AcelRx's current expectations and inherently involve significant risks and uncertainties. AcelRx's actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, DZUVEO in Europe and Zalviso in the United States; the possibility that the FDA may dispute or interpret differently the results of the company's Human Factors study to validate the effectiveness of the changes in the Directions for Use, or the supplemental information included in the resubmission of the NDA for DSUVIA; EC review of the CHMP positive opinion and approval recommendation for the DZUVEO MAA, and the possibility that EC may dispute or interpret differently clinical results obtained from the DZUVEO Phase 2 and 3 studies; the possibility that the FDA may dispute or interpret differently the results of the Zalviso development program, including the results from the IAP312 clinical trial; the accuracy of AcelRx's estimates regarding expenses, capital requirements and the need for financing; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-K filed with the SEC on March 9, 2018. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations, except as required by law.

 

 

 

 

 

 

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SOURCE AcelRx Pharmaceuticals, Inc.

Investors, Brian Korb, Solebury Trout, 646-378-2923, investors@acelrx.com, or Raffi Asadorian, Chief Financial Officer, AcelRx, investors@acelrx.com