The Redwood City, Calif.-based company pared its losses to -$9.7 million, or -21¢ per share, on sales of $6.4 million for the 3 months ended Dec. 31, for bottom-line growth of 8.2% on sales growth of 276.5% compared with the same period last year.
Adjusted to exclude 1-time items, losses per share were -21¢, ahead of the -24¢ consensus on The Street.
“We have taken meaningful steps towards meeting our goal of Dsuvia approval in the U.S., and we continue to make additional commercial preparations for a potential Dsuvia launch,” CEO Howie Rosen said in prepared remarks. “A key aspect of our preparations, as we announced a few weeks ago, is having appointed Vincent J. Angotti to be chief executive officer starting March 6th. Vince has over 25 years of successful commercial experience, most recently at Xenoport, where he managed the relaunch of Horizant as COO, and as CEO led their acquisition by Arbor Pharmaceuticals. I look forward to working with Vince and the AcelRx team in my continuing role on the Board of Directors.”
AcelRx did not provide financial guidance for the full year of 2017.
ACRX shares were trading at $3.35 apiece today in afternoon trading, up 4.7%.
The company said earlier this week that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year.
The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe acute pain resulting from trauma or injury.
Dsuvia is investigational and not approved in any country.
AcelRx’s NDA was supported by the sufentanil tablet’s clinical program, which included 4 clinical trials evaluating the sublingual painkiller as a treatment for acute pain in postoperative and emergency department patients. The data showed that patients treated with the sufentanil therapy demonstrated alleviation from pain as early as 15 minutes after they were dosed. Adverse events associated with treatment were similar to that of opioid therapy – nausea, headache, vomiting and dizziness.