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AcelRx Provides Encouraging Q2 Update

Douglas Johnson profile picture
Douglas Johnson


  • ACRX reported Q2 financial results yesterday after hours.
  • AdCom meeting date to be finalized and announced shortly; PDUFA date is Nov. 3.
  • Current IV opioid shortage provides a window of opportunity for Dsuvia's potential entrance into the market.
  • Cash and short-term investments totaled $50.1 million (not including the $20 million raised from the July equity offering); quarterly burn rate remains around $10 million.

Yesterday, August 2, AcelRx Pharmaceuticals (NASDAQ:ACRX) presented its second quarter update. On the whole, the update was quite positive - the company is clearly expecting approval of Dsuvia in November and has already hired sales representatives and developed a strategic, well-researched marketing plan. Additionally, ACRX provided some positive clarification on the reasoning behind its recent equity dilution.

Clinical Progress

CEO Vince Angotti began the call with an update on the company's significant clinical progress in Q2 and the outlook going forward. First, in mid-April, the company completed the human factors study required by Dsuvia's October 2017 CRL. Later in April, Dsuvia received a positive opinion from the CHMP in Europe (which was followed by a European Commission approval for Dsuvia in late June). Finally, and most importantly, in May, ACRX announced that the FDA had accepted ACRX's NDA resubmission for Dsuvia and set a PDUFA date of November 3.

Management are quite bullish on Dsuvia's chances of approval, as they believe that the company has fully addressed the points of concern outlined by the FDA in Dsuvia's CRL. Now, the company has begun looking forward. An advisory committee meeting for Dsuvia has been tentatively scheduled, and ACRX will announce the meeting's date once it is officially finalized. If approved, ACRX is planning a commercial launch in Q1 2019, and has already hired sales reps and developed a commercialization plan for North America.

Importantly, CEO Vince Angotti noted that the company had originally intended to wait until after approval of Dsuvia to begin building out a sales team. However, due to the current opioid shortage, "an increasing number of potential customers have expressed interest in Dsuvia," according to Angotti; as such, the company has started hiring a sales force so as to be better positioned for commercialization and distribution immediately post-approval. This move speaks

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Douglas Johnson profile picture
I am currently in my senior year at the University of Southern California, where I am double majoring in business administration and accounting. After completing my degree, I plan to sit for the CPA and work several years in public accounting before assessing my options again. I am very interested in emerging, clinical-stage biotech companies, and specialize in researching and uncovering companies which are undervalued heading into catalyst events. In biotech, every investor will have losers, and sometimes big losers; picking big winners and small losers is key for success in trading this industry. As such, my overall strategy hinges on finding and investing in companies with minimal downside but strong potential upside.

Analyst’s Disclosure: I am/we are long ACRX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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