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Avanir Pharmaceuticals (AVNR)

F2Q11 Earnings Call

May 09, 2011 04:30 p.m. ET


Ian Clement - Investor Relations

Keith Katkin - President and CEO

Christine Ocampo - VP of Finance

Randall Kaye - Chief Medical Officer


Ritu Baral - Canaccord Genuity

Thomas Wei - Jeffries

Carol Werther - Summer Street Research

Greg Wade - Wedbush Securities



Good afternoon. My name is Piya and I will be the conference operator today. At this time I would like to welcome everyone to the Avanir Pharmaceuticals fiscal 2011 second quarter conference call. (Operator Instructions)

Thank you. At this time I would like to turn the conference over to Mr. Ian Clement. Sir, you may begin.

Ian Clement

Thank you and good afternoon everybody. Joining me on today’s conference call are Keith Katkin, President and Chief Executive Officer, Bill Sibold, Chief Commercial Officer; Christine Ocampo, Vice President of Finance and Dr. Randall Kaye, Chief Medical Officer.

Earlier this afternoon Avanir issued a news release announcing the company’s results for fiscal 2011, second quarter and first six months. If you have not received this news release or if you would like to be added to the company’s distribution lists please call the investor relations of the company or you can sign up through the IR section of the company’s website.

Copies of news releases and SEC filings can also be found in the IR section of our website. There is always a gap, I would like to remind you that the statements made on the call represent our judgment as of today, May 9, 2011. Our remarks and responses to questions during this conference call may constitute forward-looking statements, including plans, expectations, and financial projections, all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ materially from the expected results expressed in our forward-looking statements.

The company’s actual results may differ materially from the statements made during today’s call and the company undertakes no obligation to update any of these statements.

From an investor communications perspective we will be presenting an overview of the company at one meeting this month, tomorrow, Tuesday May 10th, we will present at the Bank of America/Merrill Lynch healthcare conference in Las Vegas, Nevada. A webcast of this presentation will be accessible through the investor relation section of our website.

With that said, I would now like to turn the call over to Keith.

Keith Katkin

Thank Ian, and thank you for joining us on the conference call today. During today’s call I would like to discuss recent achievements and provide an overview of our business. I will then hand the call over to Bill Sibold who will comment on the launch of NUEDEXTA, the commercial potential moving forward and why he found it a compelling opportunity to join Avanir.

Christine will then follow with an update on the quarter’s financial results that were released earlier today. Finally, Randall will then discuss our clinical plans for AVP-923, I will then conclude with an update on our key upcoming milestones and events.

Second quarter of 2011 marked another exciting busy and successful period for Avanir. Before adjusting the launch of NUEDEXTA I would like to take a moment to highlight a couple of other recent corporate highlights.

First, as we transition from a development stage company to an integrated commercial stage biopharmaceutical company ensuring we have the right talent in place is a key imperative for us. In the first few months of calendar 2011 we made a couple of important additions to the senior management team. This morning we announced Elona Kogan, has been appointed in the position of Vice President of Legal Affairs. Elona’s legal, regulatory and business expertise will be a valuable asset to our organization.

Promotion of Greg Flesher to the critical role of Chief Business Officer will help position Avanir to grow into a successful CNS company. Greg’s broad pharmaceutical background in business development, sales and marketing and research and development provide strong foundation to achieve this growth through an increased focus on business development and product lifecycle management.

In April, I was delighted that we were able to announce the appointment of Bill Sibold to the position Chief Commercial Officer. Previously, Bill was responsible for leading a $2.8 billion franchise and the management of over 800 people in the commercial organization of Biogen Idec. His proven ability to build and lead cross functional teams to drive growth, to develop and launch new products further enhances our already strong commercial leadership team.

Second, the filing of an IND application with the FDA for AVP-923 for the treatment of central neuropathic pain in patients with multiple sclerosis underscores our commitment to the continued development of AVP-923 for additional indications. Third, the recently announced PRISM registry, the largest ever observational study in PBA will allow us to further assess the prevalence of PBA across multiple underlying neurologic conditions and PBA’s impact on quality of life.

Moving on to the launch of NUEDEXTA, I believe we are off to a promising start as we build and develop a market for the first and only FDA approved treatment for patients living with PBA. We are measuring our success across a number of variables from a broad perspective including both quantitative and qualitative measures. We agree prescription data is trending in a positive direction and demonstrating overall continued growth. Awareness of PBA and NUEDEXTA are critical to the long term success of our business. Market research shows that awareness is growing through such activities as field sales force interactions, peer to peer speaker programs and advertising.

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