AVEO Pharmaceuticals, Inc. (AVEO)

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AVEO Pharmaceuticals, Inc. (AVEO)

Discussion of Strategic Restructuring Conference

June 05, 2013 8:30 am ET


David B. Johnston - Chief Financial Officer and Principal Accounting Officer

Tuan Ha-Ngoc - Chief Executive Officer, President and Director

William J. Slichenmyer - Chief Medical Officer


Adnan S. Butt - RBC Capital Markets, LLC, Research Division

Anupam Rama - JP Morgan Chase & Co, Research Division

Michael G. King - JMP Securities LLC, Research Division

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Christian Glennie - Edison Investment Research Limited



Thank you, for holding, and welcome to AVEO Oncology Conference Call. [Operator Instructions] Please be advised that this call is being taped at the company's request, and will be archived on the company's website for 2 weeks from today.

At this time, I would like to introduce Mr. David Johnston, Chief Operating Officer at AVEO.

David B. Johnston

Thank you, operator, and thank you, all, for joining us this morning. With me today is Tuan Ha-Ngoc, our President and Chief Operating Officer; and Bill Clinton Meyer, Chief Medical Officer, who will be joining us for Q&A.

Let me remind everyone that certain matters discussed today may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and these may include statements about AVEO's future expectations, plans and prospects, financial projections, clinical development and regulatory timelines, as well as potential approval and success of our product candidates. These statements involve risks and uncertainties, which are described in the Risk Factors section of our most recent Form 10-K 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're not taking on an obligation to do so. So with that, I will now turn the call over to Tuan.

Tuan Ha-Ngoc

Thank you, Dave, and thank you, all, for joining us this morning. This is an incredibly sad day for AVEO. Today, we are saying goodbye to many talented friends and colleagues, who dedicated their professional life to fighting cancer.

I'm sorry the results weren't as we had hoped. Sorry for the employees, sorry for the investors and sorry for the patients. However, in these circumstances, we owe it to all 3 to move the company forward, and we need to do it with the assets, both scientific and financial, that we have.

Unfortunately, downsizing is a necessary part of this process. Let me also thank all of you for your patience during this difficult period for AVEO. I realized that this has been as frustrating for all of you as it has been for us.

Since the ODAC meeting, our ability to communicate has been limited by the fact that our NDA remains under review by the FDA, and also by our need for ongoing discussions with our partner, Astellas. In addition, we have been conducting our own flow internal review of the implications of ODAC recommendation for the company. The tivozanib NDA remains under review with the FDA, and therefore, we believe it would not be appropriate to discuss any regulatory aspects of NDA submission at this time. We intend to address this topic once we receive definitive action from the FDA.

However, based on the recent ODAC meeting, we believe that it is unlikely that tivozanib will receive FDA approval for RCC at this time.

After Astellas informed us of its decision not to proceed with the MAA filing in Europe, as well as not to fund new trials in RCC, we reviewed our options with key outside RCC experts and also conducted our own analysis of the options for proceeding in this indication. Our conclusion was that, while we continue to believe that tivozanib offers a benefit to patients with RCC, we simply did not see a viable fast-forward in this indication at this time.

This was a difficult conclusion for us because it will come as a tremendous disappointment to patients and their families, as well as for the larger RCC community, including our investigators and nurses.

Again, I'm sorry that the outcome could not have been more positive for patients, for our employees, and for investors.

Despite this disappointment, we need to move AVEO forward, and that is what we like to discuss with you today.

In developing a fast-forward, we are guided by 2 overarching goals: One, we will conserve our existing financial resources by implementing a strategy that we expect to extend our cash runway for at least 2 years so that we have the opportunity to create value to upcoming inflection points, including data readouts for ongoing clinical trials; Two, we will focus our R&D efforts on areas in oncology, where our unique insight derived from our human response platform will allow us to develop targeted agents, with the potential to provide meaningful clinical benefit for specific patient populations.

Why these 2 goals? The foothold of expanding the cash runway reflects our desire to create value for our shareholders with resources, both scientific and financial, that we already have. Second, our clinical pipeline already includes products, which target 3 very important pathways in cancer: VEGF, HGF/c-Met and ERBB3.

In addition, we have multiple promising assets in late preclinical development. Our development strategy going forward will be to leverage insights with the right [ph] from our proprietary Human Response Platform to design clinical studies in clearly defined patient populations where there are limited treatment options available today. Our objective is to be in position to demonstrate a meaningful impact on patient outcomes that could enable a clear regulatory pathway to approval.

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