AVNR

Avanir Pharmaceuticals, Inc. (AVNR)

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Avanir Pharmaceuticals, Inc. (AVNR)

F1Q13 Earnings Call

February 7, 2013 4:30 PM ET

Executives

Ian Clements – Head, IR

Keith Katkin – President and CEO

Christine Ocampo – VP, Finance

Rohan Palekar – SVP and Chief Commercial Officer

Joao Siffert – SVP, R&D and Chief Scientific Officer

Analysts

Charles Duncan – Piper Jaffray

Thomas Wei – Jefferies

Jason Butler – JMP Securities

Ritu Baral – Canaccord

Carol Werther – Summer Street Research

Gregory Wade – Wedbush Pac Grow Life Sciences

Presentation

Operator

Good day ladies and gentlemen and welcome to the Avanir Fiscal 2013 Pharmaceuticals Earnings Conference Call. My name is Dianna. I’ll be the operator for today. At this time all participants are in listen-only mode. Later, we will conduct a question-and-answer session. (Operator Instructions)

As a reminder this conference is being recorded for replay purposes. I would now like to turn the call over to your host, Dr. Ian Clements, Head of Investor Relations. Please go ahead.

Ian Clements

Thanks, Dianna and good afternoon everybody. I’d like to welcome you to our conference call to discuss our financial and operation results for the fiscal 2013 first quarter.

Today is the second anniversary of the commercial launch of NUEDEXTA hence it is an opportune time to discuss the success we have achieved during the last two years and the strong momentum heading into 2013. We’ve recently undertaken several initiatives to help drive further ways of PBA and NUEDEXTA and to accelerate revenue growth.

To discuss our results and these initiatives, I’m joined today by several members of our leadership team. Our President and CEO, Keith Katkin will lead the call today by providing a brief strategic overview of our business. After Keith, our Vice President of Finance, Christine Ocampo will review our quarterly results and provide guidance for our new fiscal year. Our Chief Commercial Officer, Rohan Palekar will highlight NUEDEXTA performance followed by Dr. Joao Siffert, Chief Scientific Officer who will provide the pipeline update. For the Q&A portion of today’s call we’ll also be joined by Dr. Randall Kaye Chief Medical Officer; and Greg Flesher, our Chief Business Officer.

During the course of this conference call we will be making certain forward-looking statements. These statements are subject to numerous risks and uncertainties and reflect our current expectations and judgments. Examples of these forward-looking statements include statements relating to our expectations for NUEDEXTA sales and growth including market opportunity, future expense levels, the timing and success of future of development of AVP for other indications, the potential approval of NUEDEXTA in new markets and the timing and success of the development of AVP-786.

Actual results could vary materially from the results anticipated by these statements. Investors should read the risk factors set forth in Avanir’s Form 10-K for the year ended September 30, 2012 and periodic reports filed with the Securities and Exchange Commission.

Before I turn the call over to Keith, I wanted to let everyone know that we’ll be referencing a new slide in our corporate presentation during this discussion. And the updated quarter presentation can be found on the Avanir website in the Investor Relations section.

And with that said, I’ll turn the floor over to Keith Katkin. Keith?

Keith Katkin

Thanks Ian, and my thanks to each of you for joining us today. We’re building a leading mid-cap biopharmaceutical business designed to provide innovative new therapies to patients with high unmet needs. Our strategy to realize this goal is underpinned by three key strengths. First, our platform, NUEDEXTA. Today marks the second anniversary of the launch of NUEDEXTA. During these past two years NUEDEXTA has helped treat tens of thousands of PBA patients and has become a commercially meaningful product.

The number of PBA patients benefiting from NUEDEXTA has steadily grown each month. I am very pleased that during the month of January we reached an important milestone where we exceeded 3,000 prescriptions per week demonstrating continued growth in our business. Based on the data generated so far and results expected from ongoing studies, NUEDEXTA provides an important platform for us to build a leading mid-cap specialty biopharmaceutical company.

Second, our people. During fiscal 2012, we created the infrastructure to promote NUEDEXTA to healthcare providers practicing in skilled nursing facilities. With our recent institutional sales force expansion implemented during the first fiscal quarter of 2013, we now have approximately 80 full-time equivalent sales representatives focused on the institutional setting. We are very encouraged by the adoption of NUEDEXTA in the institutional setting so early in the launch phase.

Prescriptions from this segment now account for over half of our business and we believe the significant opportunity remains with between 100,000 and 300,000 residents in the skilled nursing facilities suffering from PBA. We are excited about our recent expansion in the institutional setting and firmly believe that we are uniquely positioned with one of the largest and most capable institutional sales forces in the United States. We expect to realize the full impact of this expanded sales force in the coming months.

Third, our pipeline. From a clinical perspective I am delighted with the continued progress we are making in our Phase II trials exploring therapeutic use in Alzheimer’s disease, Central Neuropathic Pain and Parkinson’s disease. Additionally as reported in today’s press release, we announced extremely encouraging interim results from the Phase I study examining the pharmacokinetics of AVP-786, our next generation asset which as a reminder has a composition of methorphan through at least 2030.

Read the rest of this transcript for free on seekingalpha.com