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AVANIR Pharmaceuticals (



Q3 2010 Earnings Call

November 30, 2010 11:00 a.m. ET


Brenna Mullen - Investor Relations

Keith Katkin - President and CEO

Christine Ocampo - VP of Finance

Randall Kaye - Chief Medical Officer


Ritu Baral - Cannacord Genuity

Andrew Glasheen - First Capital Alliance

Greg Wade - [Wedbush Securities]


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Good morning. At this time, I would like to welcome everyone to the AVANIR Pharmaceuticals fiscal 2010 fourth quarter and fiscal year end conference call. [Operator Instructions.] Thank you Ms. Mullen, you may begin your conference.

Brenna Mullen

Thank you and good morning everyone. Joining me on today's conference call is Keith Katkin, president and chief executive officer, Christine Ocampo, vice president of finance and Dr. Randall Kaye, chief medical officer.

I will begin the call by addressing our forward-looking statements. Following this, I'll turn the call over to Keith Katkin.

As a reminder, the statements made on this call represent our judgment as of today, November 30, 2010. 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.

These forward-looking statements include, but are not limited to, the anticipated timing and success of the commercial launch of NUEDEXTA, AVANIR's ability to market and sell NUEDEXTA in the United States, the safety and efficacy of NUEDEXTA, the long-term commercial potential for NUEDEXTA, the initiation of new clinical studies for NUEDEXTA, advancing the European regulatory status of NUEDEXTA, as well as statements regarding our financial ability to support the initial launch of NUEDEXTA and other activities, anticipated expenditure levels, and future reimbursement coverage for NUEDEXTA.

We encourage you to take the time to review our recent filings with the Securities and Exchange Commission, which present these matters in more detail as well as related risk factors. AVANIR disclaims any intent to update any forward-looking statements made during this call.

Now I will turn over the call to Keith Katkin.

Keith Katkin

Thank you Brenna, and good morning everyone. Thank you for joining us on our fiscal 2010 fourth quarter and year-end earnings call. I'll start today's call by providing a brief overview of our business before turning it over to Christine Ocampo, who will review our financial results, followed by Dr. Randal Kaye, who will discuss the recent approval of our first-in-class drug, NUEDEXTA.

Fiscal 2010 has been a year of great success and accomplishment for AVANIR. This year marked a significant transition for AVANIR, as we broadened our focus from clinical and regulatory success to market development and commercial readiness.

Now, with the FDA approval of NUEDEXTA as the first and only treatment for pseudobulbar affect, or PBA, we are fully accelerating those activities in order to ensure a successful commercial launch in February of 2011. Everyone at AVANIR is thrilled to have the opportunity to provide NUEDEXTA to patients that are suffering from the debilitating emotional outbursts of PBA, and who, until now, had no approved treatment options.

The past year was highlighted by key accomplishments such as presenting NUEDEXTA data at several prestigious medical conferences, announcing favorable safety and efficacy results from the open label extension of the STAR trial, submission to the FDA of our complete response to the October 2006 approvable letter, and finally, and most importantly, the FDA approval of NUEDEXTA for the treatment of PBA in late October. This approval occurred on the FDA-established action date with a broad indication that allows access to NUEDEXTA for all patients suffering from PBA.

We also accomplished several achievements to set the stage for a successful commercial launch and long commercial life cycle for NUEDEXTA. First, in February, we announced that the United States Patent and Trademark Office issued a new patent that extends the period of intellectual property protection for NUEDEXTA into 2025. Subsequently, we identified new case law that allowed us to extend the patent protection into late 2026.

This accomplishment strengthened our NUEDEXTA intellectual property portfolio and should provide approximately 15 years of revenue generation in the United States. In addition to this new patent, we continued to strengthen our intellectual property portfolio by filing two new U.S. patent applications for NUEDEXTA.

Second, subsequent to the end of the fiscal year, we strengthened our balance sheet by raising gross proceeds of $88 million in a public offering of common stock. We believe the size, favorable financial terms, and strong investor syndicate, including several large long-only institutional investors, demonstrates the high level of interest and excitement about AVANIR in the financial community.

I am pleased to announce that now, with approximately $125 million in cash on hand, we expect to be able to fully fund the commercialization of NUEDEXTA, the additional clinical development of NUEDEXTA for follow-on indications, and further development of our European regulatory strategy.

In addition to obtaining adequate financial resources, during the past year we have diligently taken steps to prepare for the approval and launch of NUEDEXTA by initiating PBA disease-awareness campaigns for both our target physicians and patient audiences, as well as building up our commercial team by filling key leadership positions and recruiting an experienced sales force.

Unlike many companies our size, we believe that commercialization is a core competency of the AVANIR leadership team. AVANIR has the benefit of being a somewhat reverse-engineered biotech company. Whereas most companies start with a focus on research and development and need to expand into commercialization, the AVANIR leadership team all have significant commercial experience and a demonstrated track record of success.

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