AVANIR Pharmaceuticals (AVNR)
F3Q10 (Qtr End 06/30/10) Earnings Call
August 05, 2010 11:00 am ET
Brenna Mullen - IR
Keith Katkin - President and CEO
Christine Ocampo - VP of Finance
Randall Kaye - CMO
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After the speakers' remarks, there will be a question and answer session. (Operator Instructions). Thank you Ms. Mullen, you may begin your conference.
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, August 5, 2010. Our remarks and responses to questions during this conference call may constitute forward-looking statements, including plans, expectations and financial projection, 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 and obtaining FDA approval for AVP-923 and subsequent launch timing, as well as statements regarding anticipated expenditure levels and future cash balances.
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 to Keith Katkin.
Thank you, Brenna and good morning everyone. Thank you for joining us on our fiscal 2010 third quarter earnings call. I'll start today's call by providing a brief update on our overall business before turning the call over to Christine Ocampo who will review our financial results followed by Dr. Randall Kaye, who will provide a clinical and regulatory update for our investigational drug AVP-923 formally known as Zenvia.
Before I begin my comments, I want to let everyone know that we will now be referring to Zenvia as AVP-923 until such time that we receive FDA approval. The FDA recently informed us, that our proposed trade name Zenvia, was not accepted by the agency due to promotional reasons.
This is a common occurrence within the pharmaceutical industry that we were [prepared] for and as such we immediately submitted additional brand names to the FDA for consideration. We do not expect for the review of a new proposed trade name to affect the anticipated approval or the launch timelines.
Now, I'd like to move on to the third fiscal quarter business update. Earlier in third fiscal quarter of 2010, we achieved an extremely important milestone for AVANIR with submission of our complete response to the October 2006, NDA approvable letter for AVP-923 for the treatment of pseudobulbar affect or PBA.
14 days after submission, the FDA acknowledged receipt of our complete response until an action date of October 30, 2010. We continue to believe that we have provided the agency with all of the information they need to access the benefit risk profile of AVP-923 in-patience with PBA.
Dr. Kaye will provide an update on the overall regulatory review process in his comments. With the review timeline set, we have accelerated our market development activities in order to prepare for a successful launch of AVP-923 for into our first calendar quarter of 2011.
We have made excellent progress in building up our commercial team with several key hires in leadership roles including the previously announced hiring of Michael McFadden as our Vice President of Sales and Manage Markets. In addition, we have filled several other leadership positions in the Sales and Manage Markets.
We have also started the process of recruiting our specialty sales force to identify top talent to ensure quick on boarding to meet our launch timelines. Our current plan is to expand contingent offers to 75 sales representatives and seven regional sales managers throughout the United States by the October 30, 2010 action date.
This AVP-923 is approved by the action date, we plan to immediately hire the 75 sales representatives and initiate sales training activities to help ensure a successful launch of AVP-923 in the first calendar quarter of 2011.
During the last quarter, we also continued to conduct market research and advisory board meetings. One of the key areas of research was pricing and managed care coverage to access the optimal price to balance product access with maximizing revenues. We currently expected AVP-923 will be priced between $3000 and $5000 a year and we will continue to evaluate pricing as more research data becomes available.
In addition to building our commercial team, we also continue to focus on raising awareness of PBA among our target position and patient audiences. We have strengthened our medical affairs organization by hiring additional Medical Science Liaisons to interact with key opinion leaders in Neurology and Psychiatry and that had a significant presence at recent medical meetings with a boost focused on PBA education.