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Acura Pharmaceuticals (ACUR)

Q2 2012 Earnings Call

July 31, 2012 8:30 am ET


David Carey

Robert B. Jones - Chief Executive Officer, President and Director

Peter A. Clemens - Chief Financial Officer, Principal Accounting officer, Senior Vice President of Investor Relations and Secretary


Michael Kallai Tong - Wells Fargo Securities, LLC, Research Division

Kevin Kedra - Gabelli & Company, Inc.

James Liberman

Robert Cummins Hazlett - Roth Capital Partners, LLC, Research Division

Tom Marks



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Good day, everyone, and welcome, ladies and gentlemen, to the Acura Pharmaceutical's Conference Call. As a reminder, today's call is being recorded. [Operator Instructions] At this time, I'd like to turn the call over to David Carey of Lazar Partners. Please go ahead, sir.

David Carey

Thank you. Before we begin, I'd like to remind you that any discussion that takes place during this conference call may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements reflect management's current view of future events and operations including, but not limited to, statements pertaining to the company's expectations regarding OXECTA and other products licensed to Pfizer, the company's product development pipeline, commercial plans for the NEXAFED product, the commercial potential of the company's products and plans to maximize this potential, future product sales and financial results and the company's strategy for long-term growth. Forward-looking statements involve certain significant risks and uncertainties, and actual results may differ materially. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

Certain factors that may cause actual results to differ materially from the forward-looking statements are discussed in the company's press release issued yesterday evening and the Risk Factors section and other sections of the company's Form 10-K for the year ended December 31, 2011, as filed with the Securities and Exchange Commission.

Acura does not undertake to publicly update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.

I'll now turn the call over to Bob Jones, President and CEO of Acura Pharmaceuticals.

Robert B. Jones

Thanks, David. Good morning, and thank you for joining us to discuss our second quarter 2012 financial results and corporate update.

Let's start with the AVERSION opioid products, which are designed to discourage some of the common methods of tampering associated with abuse and intentional misuse of the opioids. Last week, Pfizer notified us of their decision to return the 3 AVERSION opioid products in development while continuing to commercialize the product OXECTA. You will recall that our partnership with Pfizer was a result of our merger of our former partner, King Pharmaceuticals. Pfizer has had our 3 development products for 16 months following its acquisition of King. In that time, they have completed 1 bioequivalence study, held 1 FDA meeting and has not initiated any additional clinical studies.

In contrast, in the 8 months between King's announcement of the bioequivalence results on OXECTA and the submission of the NDA for that product, King completed 2 clinical studies, held an FDA meeting and completed all the other related development activities. It is against this background that we welcome our products back. We now control the timing and execution of these products, and we believe we have the resources and the expertise to execute the development plan for these products once they are formally returned by Pfizer. In the scheme of pharmaceutical development, these are not overly expensive products to develop if all goes well. We will also consider partnering these products with an alternative strategic partner for the development and commercialization of the returned products. Importantly, there is nothing we are aware of to indicate there are any clinical or regulatory barriers to developing these products.

The lead development product, hydrocodone with acetaminophen has demonstrated bioequivalence to its reference drug and the development plan discussed with the FDA at a pre-IND meeting is generally comparable to the development plan used for OXECTA. We will work with Pfizer to in effect an appropriate transition of the development products back to Acura within the next 12 months. Once we have the products back, we will be in a position to assess our strategic options for them, including the potential to relicense them to a motivated partner for development and commercialization. Pfizer has impressive marketing capabilities that have the potential to make OXECTA a long-term success.

However, we believe that their decision to price OXECTA at such a significant premium to the market has been a hindrance to the initial uptake of this product. Even so, we remain hopeful that their continued efforts position OXECTA as part of the solution to combat the abuse and misuse of opioids will soon be evidenced in not only the sales of OXECTA, but also may benefit our other AVERSION opioid products as well.

The problem of prescription opioid abuse persists. Two recent New York Times articles provided anecdotal information that abusers of extended-release opioids may be shifting to other drugs, including immediate release opioids when faced with tamper-resistant products. The Centers for Disease Control and Prevention estimates 1 person dies every 19 minutes from prescription drug abuse in the United States. We are encouraged by the fact that state and national lawmakers are devoting more attention to this epidemic and proposing legislation to combat the issue.

Importantly, last month, a bipartisan group of congressmen, led by Representative William Keating of Massachusetts, introduced the Stop Tampering of Prescription Pills Act of 2012, otherwise known as the STOPP Act. If approved, the STOPP Act would provide a framework for defining tamper-resistant technologies and encourage the development and adoption of tamper-resistant opioids. This legislation has the potential to initiate a dialogue between physicians, regulators, third-party payers and others concerned with the epidemic of prescription opioid abuse and misuse to promote the proper use of tamper-resistant technologies, along with other risk mitigation strategies.

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