Avanir Pharmaceuticals, Inc. (AVNR)
F1Q10 (Qtr End 12/31/09) Earnings Call Transcript
February 2, 2010 11:00 am ET
Brenna Mullen – IR
Keith Katkin – President and CEO
Christine Ocampo – VP, Finance
Randall Kaye – SVP, Clinical Research and Medical Affairs, Chief Medical Officer
Mike King – Merriman Curhan Ford
Carol Werther – Summer Street Research Partners
Jim McCamant – America HealthCare
Mark Mcinerney – Visium Assets
Previous Statements by AVNR
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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 2, 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, among others, statements about our expectations about the likelihood of success in obtaining FDA approval for Zenvia, as well as statements regarding anticipated expenditure levels, future cash balances, clinical development timelines, and intellectual property protection.
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 on this call.
Now, I will turn the call over to Keith Katkin.
Good morning everyone. Thank you for joining us on our fiscal 2010 first quarter earnings call. I will start today’s call by providing a brief commentary on our overall business performance before turning the call over to Christine Ocampo, who will review our financial results followed by Dr. Randall Kaye who will discuss our Zenvia clinical development programs.
The first quarter of fiscal 2010 was a very exciting time at AVENIR as we continued to build on the positive momentum created after announcing the STAR trial results in August. With the positive outcome from the confirmatory Phase III STAR trial, we opened the fiscal year by presenting the full Zenvia data set at three prestigious medical conferences. In addition, we announced favorable safety and efficacy results from the open-label extension of the STAR trial, and very importantly we received a notice of allowance from the USPTO that our new patent will soon be issued extending the US patent protection of Zenvia into 2025.
From an operational perspective, we shifted our focus from clinical development activities to preparing the regulatory submission that is necessary to secure FDA approval and initiating commercial readiness activities to support an expected product launch in early 2011.
Last quarter on the regulatory front, with the STAR trial completed, we sought alignment with the FDA on the components of our submission package for the first full response filing. In November, we announced that the company had engaged in a constructive written communication with the FDA, and based on the feedback from the FDA, we planned to proceed with the filing of the full response with existing Zenvia data. Our clinical team is now busy preparing to file the response early in the second quarter of 2010. We remain optimistic that our full response will address the questions raised by the FDA in their approvable letter and will serve as the basis for an approval decision in the fourth quarter of 2010.
In order to prepare for a US launch in early 2011, we have initiated significant commercial readiness in medical affairs activities. We have focused on long lead-time items such as manufacturing and packaging as well as initiating PBA disease awareness programs for physicians and patient audiences. We intend to be very active at important medical meetings in 2010 to raise awareness of PBA among neurologists, psychiatrists, and other physician specialties that manage patients suffering from PBA. We have also been working with key patient advocacy groups to educate their constituencies that are at risk of PBA. Our goal is to educate the market about PBA and create a platform for a successful Zenvia launch in early 2011.
While we are open to evaluating all strategic options, we firmly believe we can successfully commercialize Zenvia ourselves. Members of our senior team have significant commercial experience having launched and managed several blockbuster brands at large pharma and biotech companies. Further, we demonstrated our commercial capabilities at AVANIR by successfully re-launching FazaClo in 2006 and more than doubling the sales trajectory before selling their brand in 2007 to fund the Zenvia confirmatory Phase III STAR trial. We have now begun to staff up key commercial roles including posting openings for a vice president of sales and a head of managed markets. Our actions demonstrate that we have the conviction and expertise to successfully bring Zenvia to market.
In summary, 2010 will be a transformational year for AVENIR. We are on the brink of filing our regulatory application and expect an FDA approval decision before year-end. Considering the imminent filing of the full response to the FDA, our internal commercial expertise, and the allowance of our new patent that provides patent protection in the US in the late 2025, we believe that we are well positioned to create substantial value for our shareholders. We are very excited of the prospect of soon becoming a leading developer and marketer of innovative therapies for central nervous system disorders.