Avanir Pharmaceuticals' CEO Discusses F3Q12 Results - Earnings Call Transcript

Avanir Pharmaceuticals (AVNR)

F3Q12 Earnings Call

August 08, 2012, 04:30 pm ET


Ian Clements - Head, IR

Keith Katkin - President & CEO

Rohan Palekar - CCO

Christine Ocampo - VP, Finance

Dr. Joao Siffert - SVP, Research and Development


Charles Duncan - JMP Securities

Ritu Baral - Canaccord



Good day everyone and welcome to the Avanir fiscal 2012 third quarter conference call. My name is Louisa and I will 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 call is being recorded for replay purposes. I’d now like to turn the call over to Dr. Ian Clements, Head of the Investor Relations. Please proceed, sir.

Ian Clements

Thanks, Theresa and good afternoon everybody. I would like to welcome you to our conference call to discuss our financial and operating results for the fiscal 2012 third quarter.

To discuss our results, I am joined by Keith Katkin, our President and Chief Executive Officer, who will provide a strategic overview of our business and fiscal 2012 third quarter performance. Christine Ocampo, Vice President of Finance, who will provide additional details on our financial performance during the quarter. Rohan Palekar, our Chief Commercial Officer; and Dr. Joao Siffert, Senior Vice President, Research and Development, who will provide an R&D update. For the Q&A portion of today's call we will also be joined by Dr. Randall Kaye, our Chief Medical 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 includes statements relating to our expectations for NUEDEXTA sales and revenue growth, future expense levels, the timing and success of future development of AVP for other indications and the potential approval of NUEDEXTA in new markets.

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, 2011 and periodic reports filed with Securities and Exchange Commission.

From an investor communications perspective, we will be presenting an overview of the company two meetings this month. Next week we will present at the Canaccord Genuity Conference in Boston and the Wedbush Pacific Growth Healthcare Conference in New York. A webcast of these presentations will be accessible through the Investor Relations section of our website.

With that said, I'll now turn the call over to Keith Katkin. Keith?

Keith Katkin

Thank you, Ian and good afternoon everyone. The Fiscal 2011 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 and regulatory initiatives. We are delighted to announce that net NUEDEXTA revenues for the quarter exceeded $10 million representing net revenue growth of over 37% over the previous quarter.

Gross NEUDEXTA sales also grew by 33% over the previous quarter. Five quarters post our launch we continue to set new record high prescriptions and based on our most recent weekly prescription numbers of 2232, our annualized gross run rate is approximately $52 million.

Later on the call, Rohan will be giving an update on our commercial activities and the strong growth we continue to see in NEUDEXTA sales.

Addressing some of the recent corporate highlights, first in June we announced a valuable new addition to our intellectual property portfolio. US patent number 8227484 entitled pharmaceutical compositions comprising Dextromethorphan and Quinidine for the treatment of neurological disorders.

This new patent claims methods for treating pseudobulbar affect or emotional ability using low dose Quinidine formulations of NEUDEXTA. This patent was issued on July 24, 2012 and was recently added to the FDA Orange Book. This additional patent listed in the Orange Book for NEUDEXTA further strengthens our patent in the States and creates another hurdle for ANDA filers to overcome.

Second, the growth we are delivering in NEUDEXTA sales combined with a strong balance sheet firmly position us for commercial success and delivery of a number of exciting catalysts in our development pipeline. The most recent clinical achievement centered around our early June announcement that the FDA has accepted the company’s investigational new drug application for the study of AVP-923 for the treatment of agitation in patients with Alzheimer’s disease. Joao will provide more details on this exciting initiative later on the call and the progress we continue to make exploring the broader potential of this dual sigma-1 agonist and NMDA receptor antagonist. With that introduction I will now ask Rohan to say a few words. Rohan?

Rohan Palekar

Thanks Keith and hello everybody. It's my pleasure to update you this afternoon on the progress we've been making in our commercial activities. The fundamentals of our commercial business remain strong and all our indicators point towards a successful 2012.

On the prescription side as Keith mentioned we saw strong quarter-over-quarter growth as prescriptions increased by approximately 33% to 26,428. Over the same period, new prescriptions grew by approximately 22% to 11,736. I would like to highlight a couple of key factors driving this growth.

First, awareness of NUEDEXTA amongst physicians continues to grow and reached an all-time high in our recently completed market research. This demonstrates that our sales and marketing initiatives are continuing to have significant impact in the marketplace.

Second, the number of physicians prescribing NUEDEXTA each week continues to grow here again reaching an all time high in June. Similarly our reach amongst nursing homes is also increasing and we now cover over a third of the beds in the country.

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

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