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AVEO Pharmaceuticals, Inc. (AVEO)
Q4 2012 Earnings Call
February 13, 2013 10:00 am ET
Monique Allaire – Director of Investor Relations
Tuan Ha-Ngoc – President and Chief Executive Officer
William Slichenmyer – Chief Medical Officer
David Johnston – Chief Financial Officer
Geoff Meacham – J.P. Morgan Securities Inc.
John Sonnier – William Blair & Co.
Adnan Butt – RBC Capital Markets, LLC
Salveen Richter – Canaccord Genuity Inc.
Thomas Wei – Jefferies & Company, Inc.
Marshall Urist – Morgan Stanley & Co. LLC
James Birchenough – BMO Capital Markets Corp.
Brian Klein – Stifel, Nicolaus & Company, Incorporated.
» AVEO Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript
» Given Imaging's CEO Discusses Q4 2012 Results - Earnings Call Transcript
At this time, all participants are on a listen-only mode. Following the formal report AVEO management will open the lines for a question-and-answer period. Please be advised that this call is being taped at the Company’s request and will be archived on the Company’s website for two weeks from today.
At this time, I would like to introduce Ms. Monique Allaire, Director of Investor Relations. Please go ahead, Monique.
Thank you, Cathy, and good morning everyone. Today, we would be talking about our 2012 financial results, detailed TIVO-1 findings and key recent developments. With me are Tuan Ha-Ngoc, our President and CEO; and Bill Slichenmyer, our Chief Medical Officer; David Johnston, our Chief Financial Officer is joining us from Italy; and Michael Bailey, our Chief Commercial Officer will join us for Q&A. The press releases issued yesterday evening and earlier today, detail our results and are available on our website at aveooncology.com.
In addition, we will be using slides during today’s call, which were filed as an 8-K with the SEC earlier this morning. You can access the webcast with those slides by going to the investor page of our website.
During this call, we may make forward-looking statements including statements in the slides, all within the meaning of the Private Securities Litigation Reform Act of 1995.
These include statements about AVEO’s future expectations and plans, clinical development and regulatory timeline, the anticipated launch of tivozanib, the potential success of our product candidates, and our financial projections. These statements involve risks and uncertainties, which are described in the Risk Factors section of our Form 8-K filed with the SEC on January 16, 2013, and available online at sec.gov.
While these forward-looking statements represent our views as of today, they should not be relied upon as representing our views in the future. We may update these statements in the future, but we are not taking on an obligation to do so.
With that, let me pass the call over to Tuan.
Thank you, Monique, and thank you all for joining us this morning. We are pleased with the progress we made in 2012, and stand ready for what will be an important year for AVEO.
Of our achievements last year, our focus on the most significant, the FDA’s acceptance of our new drug application for tivozanib for the treatment of patients with advanced RCC. The PDUFA date is targeted for July 28. This was a key milestone for AVEO, marking the development of tivozanib through clinical trials over the last five years, and now into regulatory review for approval. I am very proud of the work we’ve done in executing on our plan, and getting us to this point in the company’s evolution.
We are confident in the full NDA package that was submitted to the FDA last September. This covered data from 18 clinical trials with tivozanib including the efficacy and safety results on TIVO-1, our registration study in advanced RCC. In addition, we included the final overall survival results, which we’ll talk about a bit on this call today.
The final OS results and additional data are scheduled to be represented this Saturday February 16, at the Annual ASCO GU Symposium. Some of these data were provided in abstracts that came out last night as well as in our press release.
I’m now going to pass the call over to Bill to review those data. After that, Dave will review our financial results and guidance; then we can move to Q&A. Bill?
Thank you, Tuan. Last night, ASCO released the abstracts for ASCO GU, and lifted its embargo on the data from the posters. For AVEO’s drug tivozanib, there are five posters that will be presented, and this morning, we like to share some of those data with you. The posters will be available on the website as of Saturday, 16 which is the day that will be presented at the meeting. Before I get into the new data, I’ll take just a moment to review four quick slides to show some of the high points of what we have previously disclosed.
This slide shows the design of our pivotal study called TIVO-1. To be eligible for this study, patients were required to have advanced clear cell RCC, good performance status and have undergone prior nephrectomy. Patients were allowed to have had up to one prior systemic therapy, but not VEGF or mTOR-targeted therapies, which were prohibited.
The patients were randomized to receive either tivozanib or sorafenib in their standard doses. The study included an optional one-way crossover for patients in the control arm if they had radiographic evidence of disease progression.