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AVANIR Pharmaceuticals (AVNR)

F1Q11 (Qtr End 12/31/2010) Earnings Call

February 3, 2011 9:00 am ET


Brenna Mullen - Investor Relations

Keith Katkin - President and CEO

Christine Ocampo - VP of Finance

Randall Kaye - Chief Medical Officer


Ritu Baral - Cannacord

Matt Duffy - PGR Research

Carol Werther - Summer Street Research

Thomas Wei - Jefferies



Good morning. My name is Sarah and I will be your conference operator today. At this time, I would like to welcome everyone to the AVANIR Pharmaceuticals Fiscal 2011 First Quarter Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers remarks, there will be question and answer session. (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, February 3, 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.

These forward-looking statements include, but are not limited to AVANIR’s ability to successfully market and sell NUEDEXTA in the United States, the safety and efficacy of NUEDEXTA, the long-term commercial potential for NUEDEXTA, including the estimates of market size, the timing and the cost for 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 over to Keith Katkin.

Keith Katkin

Thank you Brenna and good morning everyone. Thank you for joining us on our fiscal 2011 first quarter earnings call. It is incredibly the second time in AVANIR as we are conducting this earnings call live from our national launch meeting with our entire sales force and commercial team after almost two months of physician call activity focused on PBA disease awareness. The team is excited and very eager to get out and start selling NUEDEXTA next Monday, February 7th.

Now, I would like to turn today’s call but I’ll provide a brief overview of our business before turning the call over to Christine Ocampo, who will review our financial results, followed by Dr. Randal Kaye, who will provide and update on NUEDEXTA development program and our medical affairs activities.

The first quarter of fiscal 2011 was a significant turning point in the history of AVANIR. We opened the new fiscal year with the FDA approval of NUEDEXTA the first and only treatment for pseudobulbar or PBA, marking an important milestone for the many patients in the U.S. currently suffering from the debilitating episodes of PBA and accelerating their transformation into a commercial enterprise fully equipped to deliver what we believe will be a successful launch.

Earlier this week we were extremely pleased to announce that NUEDEXTA is now available by prescription in retail pharmacies across the country and that our dedicated sales force will commence physician promotional activity on Monday February 7th. This truly an exciting time at AVANIR as we are on the cusp of seeing our hard work and perseverance over the past several years culminate in the launch of NUEDEXTA.

In the past quarter we focused on market development and commercial readiness and as a result, I am delighted to announce that our commercial organization is fully staffed, trained and ready to support the launch of NUEDEXTA. The commercial team has significant sales and marketing experience and a collective track record of success to help ensure a strong launch for NUEDEXTA.

Since we are building a new market in therapeutic category, we continue to educate physicians, neurologic patients and their caregivers in order to change the established behaviors and ensure patients of PBA are properly diagnosed and treated.

In order to do so, we continue work on our PBA Disease Awareness campaigns for both our target physicians and neurologic patient audiences.

In addition to our sales team educating healthcare providers about PBA and the impact it has on patient's lives, we will also be employing tactics such as print and digital advertising, representation at medical conferences and partnership initiatives with leading patient advocacy groups.

For example, the Brain Injury Association of America and the National Stroke Association have both released results of survey conducted amongst their constituents on the prevalent and impact of PBA. The Multiple Sclerosis Association of America, a national non-profit of charity, also recently conducted a survey of over 5,000 of their members and will be releasing the result of this survey within the next few weeks.

In addition, last week we trained our first wave of physicians to conduct peer-to-peer educational programs. The feedback from the physicians was very positive. They were very eager to not only educate their colleagues but also treat their PBA patients with NUEDEXTA as soon as it was available for prescription.

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