AVNR

Avanir Pharmaceuticals, Inc. (AVNR)

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Avanir Pharmaceuticals Inc. (AVNR)

F3Q13 Earnings Call

August 6, 2013 4:30 PM ET

Executives

Ian Clements – Director, 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

Roy Buchanan – Piper Jaffray

Chris Slocum – Slocum

Presentation

Operator

Good day, ladies and gentlemen and welcome to the Avanir Fiscal 2013 Third Quarter Financial Results Conference Call. My name is Cathy and I’ll be your operator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. (Operator Instructions) As a reminder, this conference is being recorded for replay purposes.

I would now like to turn the call over to Mr. Ian Clements, Director of Investor Relations. Please proceed sir.

Ian Clements

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

To discuss our results, commercial and clinical 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. Our Chief Commercial Officer, Rohan Palekar will highlight NUEDEXTA performance followed by Dr. Joao Siffert, Chief Scientific Officer, who will provide a 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’ll 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 includes statements relating to our expectations for NUEDEXTA sales and revenue growth including market opportunity, future expense levels, the timing and success of future development of AVP-923 for other indications, the potential approval of NUEDEXTA in new markets, and the timing and success of the development of AVP-786 and AVP-825. 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 any subsequent reports filed with the Securities and Exchange Commission.

From an investor communications perspective, we’ll be presenting an overview of the company at two meetings this month. Next week, we’ll present at the Canaccord Genuity Conference in Boston and the Wedbush PacGrow Healthcare Conference in New York. A webcast to these presentations will be accessible through the Investor Relations section of our website. Additionally, we are planning of holding an Investor Day in New York on October the 29, 2013. For more information on these events, please contact me in the Investor Relations Department.

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

Keith Katkin

Thank you Ian and thank you everyone for joining us on our fiscal year 2013 third quarter conference call. The fiscal 2013 third quarter was another strong quarter for Avanir. We continue to see strong growth in NUEDEXTA sales and prescriptions and made substantial progress on our clinical, regulatory and business development initiatives. I would like to start today by talking a little bit more about our corporate strategy. The first part of our corporate strategy is to establish NUEDEXTA as a global brand. We continue to do this through successful execution in the United States with growing NUEDEXTA sales as well as through our recent approval of NUEDEXTA within the European Union.

Second part of our strategy is to apply the rich pharmacology of NUEDEXTA of dextromethorphan to build a multi indication franchise for patients suffering from CNS diseases and conditions a significant unmet need. We continue to move forward on this strategy through our broad development programs for AVP-923 and for AVP-786. And the final part of our strategy is to continue to opportunistically leverage our commercial presence by continuing to acquire rights to novel products or leverage our field sales team through potential co-promotes.

Now I like to move on to high level update on our commercial performance over the last quarter. Very pleased with the commercial performance over the last quarter with nearly $25 million in the gross NUEDEXTA sales and $19 million in net NUEDEXTA revenues for the quarter. This represents an acceleration of quarter-over-quarter growth with approximately 27% increase in capsule sold in the third quarter versus the second quarter. This compares to 7% growth we saw in the second quarter over the first quarter so a 20% increase the quarter-over-quarter capsule units sold. Recently our IMS numbers if you annualize them project to an approximate NUEDEXTA run rate of $110 million so we continue to see successful commercial execution within the business.

Now, turning to progress on our clinical and regulatory portion of the business. As we reported in the last quarter our PRIME study our multiple sclerosis neuropathic pain with multiple sclerosis study completed enrollment and we expect top-line data from that study in the fourth calendar quarter of this year. Second, our agitation program in Alzheimer’s is progressing well with enrollment and we continue to expect top-line data in the middle of 2014. And finally with EMA approval quite a success for our research and development team obtaining a broad label for PBA getting two dosage strength approved with approval on hand we’re now in active discussions with potential partners as we prepare – taken a necessary steps for launch.

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