On November 5, 2020 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, reported its third quarter 2020 financial results (Press release, AcelRx Pharmaceuticals, NOV 5, 2020, View Source [SID1234570222]).
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"The third quarter represented one of our most active and successful quarters since DSUVIA’s approval," said Vince Angotti, Chief Executive Officer of AcelRx. "We’ve made significant progress on our revenue growth strategy, highlighted by our oral and dental surgery collaboration with Zimmer Biomet, the addition of DSUVIA to the Department of Defense Joint Deployment Formulary and our new U.S. Army contract. With the recent publication of data supporting DSUVIA’s strong value proposition, we have gained momentum in DSUVIA’s use within existing hospital and ambulatory surgery center customers, and the rate of scheduled formulary reviews. Progress within the Department of Defense continues and we expect the initial ordering of DSUVIA for deployed troops in the fourth quarter."
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, expanding U.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," by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain 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 the Department 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 a DoD study to aid the development of clinical practice guidelines.
Financial Information
Cash, cash equivalents and short-term investments balance was $43.0 million as of September 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 Thursday, November 5, 2020 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of AcelRx’s website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. 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. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of AcelRx’s website at www.acelrx.com.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and AcelRx is currently in discussions with potential European marketing partners.