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AVEO Pharmaceuticals (AVEO)
Q3 2012 Earnings Call
October 30, 2012 10:00 am ET
Tuan Ha-Ngoc - Chief Executive Officer, President and Director
William J. Slichenmyer - Chief Medical Officer
Michael P. Bailey - Chief Commercial Officer
David B. Johnston - Chief Financial Officer and Principal Accounting Officer
Elan Z. Ezickson - Chief Operating Officer, Executive Vice President and Chief Business Officer
Adnan S. Butt - RBC Capital Markets, LLC, Research Division
Salveen J. Richter - Canaccord Genuity, Research Division
Yigal D. Nochomovitz - Morgan Stanley, Research Division
Thomas Wei - Jefferies & Company, Inc., Research Division
Jim Birchenough - BMO Capital Markets U.S.
Howard Liang - Leerink Swann LLC, Research Division
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Thank you, Operator, and good morning, everyone. Today, we'll be talking about key recent developments and our third quarter 2012 financial results. With me are Tuan Ha-Ngoc, our President and CEO; David Johnston, our CFO; Bill Slichenmyer, our Chief Medical Officer; Michael Bailey, our Chief Commercial Officer; and Elan Ezickson, our Executive Vice President and Chief Operating Officer. The press release issued earlier today, detailing our results is available on our website at aveooncology.com.
During this call, we may make forward-looking statements 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 potential success of our product candidates and financial projections. These statements involve risks and uncertainties, which are described in the Risk Factors section of our most recent Form 10-Q filed with the SEC 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. Earlier today, we announced that AVEO has conducted a strategic restructuring designed to optimize company resources and reduce expenses to ensure 2 things: that we are well prepared and positioned to execute on the planned launch of our first product candidate, tivozanib, in 2013; and that we maintain a focused, appropriately sized research engine to build long-term value.
Turning first to the optimization of our resources. Our #1 priority is the approval and commercialization of tivozanib in kidney cancer. Behind that is the continued development of tivozanib in additional chemo types, such as colorectal and breast cancers. With this restructuring, we are directing approximately 80% of our resources to supporting the anticipated approval and planned commercial launch and market uptake of tivozanib in RCC as well as maximizing its potential in other chemo types.
We are also narrowing our efforts in our earlier pipeline research organization. We have made the strategic decision to explore further development of ficlatuzumab and certain other discovery assets through external collaborations. We will continue to utilize our core discovery and platform capabilities primarily directed to biomarker research in support of our clinical stage programs and working on select novel discovery initiatives.
Consistent with this reduction in the scope of the R&D activities outside of tivozanib, we have reduced our workforce by approximately 45 positions or 17% and closed approximately 30 open positions. The largest of our impact of this was on our research organization. These are difficult decisions, but we believe that we have aligned our resources appropriately with our updated operating plan.
In terms of the reduction in expenses, this restructuring is expected to provide AVEO with substantial cost savings in 2013 as well as over the next 3 years. Further, it extends our current cash runway to year-end 2013. We believe we have made a prudent fiscal and strategic decision in our evolution towards our goal of becoming a fully integrated oncology company, delivering novel cancer therapies to patients. In the recent weeks and months, we have gotten closer to this with the submission of our first NDA for tivozanib. With that, let me ask Bill to share some recent tivozanib highlights. Bill?
William J. Slichenmyer
Thanks, Tuan. We continue to make good progress with the development of tivozanib. As Tuan mentioned, we and our partners at Astellas submitted the NDA for tivozanib in patients with advanced RCC. The submission was based on results from our TIVO-1 study and various supportive studies and was a significant milestone for us. We look forward to the agency's response in the next month or so.
To remind you, TIVO-1 demonstrated a statistically significant improvement in PFS with tivozanib compared to sorafenib in both the overall population study as well as the prespecified subpopulation that was treatment-naive. In that patient population, tivozanib demonstrated a PFS of 12.7 months versus 9.1 months with sorafenib. In TIVO-1, tivozanib demonstrated low rates of dose reductions and interruptions with 12% and 18% respectively. Further, in our safety analysis of over 1,000 people treated with tivozanib in 17 clinical studies, it was well-tolerated. The most common adverse event was hypertension, which has been readily managed and is correlated with efficacy outcomes.