AcelRx Pharmaceuticals: Next Generation Of Pain Management Technologies



AcelRx Pharmaceuticals, Inc. (ACRX) is a specialty pharmaceutical company focused on the development of four novel therapies for the treatment of acute and breakthrough pain. The company's lead product candidate, the Sufentanil NanoTab PCA system or ARX-01 for short, is designed to solve the challenges associated with post-operative intravenous patient-controlled analgesia (IV PCA).

ARX-01 is currently in 3 Phase III trials and AcelRx is expected to report top-line data in 2H 2012 or early 2013. The company has also completed Phase II clinical trials for two additional product candidates, ARX-02 and ARX-03. ARX-02 is short for the Sufentanil NanoTab Breakthrough Pain Management System for the treatment of cancer breakthrough pain while ARX-03 also known as Sufentanil/Triazolam NanoTab is designed to provide mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office. The fourth drug candidate, ARX-04, a non-invasive, fast-onset sublingual product for the treatment of moderate-to-severe pain, is about to enter a Phase II trial under a grant funded by the Department of Defense.

In the United States, AcelRx is planning to develop and commercialize these product candidates through its own efforts or in conjunction with partners. Outside of the United States, AcelRx anticipates commercializing these products on a worldwide basis through select regional partnerships. With a stock price of $3.25 per share and fully diluted shares of 29.2 MM, AcelRx has a market cap of $73.53 MM and an enterprise value (EV) of $85.1 MM. With approximately $29 MM cash in hand, the company has enough cash resource to fund operations through early 2013, ensuring delivery of all clinical data for ARX-01 and enabling new drug application (NDA) preparation. Overall, we view that the stock is undervalued and should move significantly higher upon positive results from the ARX-01 Phase III trial data.

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