Exelixis' CEO Discusses Q4 2011 Results - Earnings Call Transcript

Exelixis, Inc. (EXEL)

Q4 2011 Earnings Conference Call

February 8, 2012 17:00 ET

Executives

Charles Butler – Investor Relations

Mike Morrissey – President and Chief Executive Officer

Frank Karbe – Executive Vice President and Chief Financial Officer

Gisela Schwab – Executive Vice President and Chief Medical Officer

Analysts

Eric Schmidt – Cowen and Company

Karen Jay – JPMorgan

Joel Sendek – Stifel

Terence Flynn – Goldman Sachs

David Miller – Biotech Stock Research

Ryan Martins – Lazard Capital

Lee Kelowski – Credit Suisse

Presentation

Operator

Compare to:
Previous Statements by EXEL
» Exelixis Management Hosts Analyst Day - Conference Call Transcript
» Exelixis' CEO Discusses at Piper Jaffray Health Care - Conference Call Transcript
» Exelixis' CEO Hosts Special Conference - Conference Call Transcript

Good day, ladies and gentlemen, and welcome to the Q4 Exelixis Conference Call. My name is (Kim) and I'll be your coordinator for today. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today's conference. (Operator Instructions)

I would now like to turn the presentation over to your host for today's conference, Mr. Charles Butler. Please proceed, sir.

Charles Butler – Investor Relations

Thank you for joining us this afternoon for our fourth quarter and full year 2011 financial results conference call. Joining me on today's call is Mike Morrissey, our President and CEO; Frank Karbe, our Executive Vice President and CFO; and Gisela Schwab, our Executive Vice President and Chief Medical Officer. As usual, Mike will start off with a brief overview and then turn the call over to Frank who will review our performance over the financial reporting period, then Gisela will provide a research and development update before the team takes questions.

As a reminder, during the course of this presentation, we will be making forward-looking statements regarding future events or the future performance of the company. Actual events or results of course could differ materially. We refer you to the documents that Exelixis files from time-to-time with the Securities and Exchange Commission, specifically, the company's most recent Form 10-Q filed on October 27, 2011. These documents contain and identify under the heading Risk Factors, important factor that could cause actual results to differ materially from those contained in any forward-looking statements, including risk related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing, Exelixis' ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; the sufficiency of Exelixis' capital and other resources, and the uncertainty of the FDA review and approval process.

And with that, I will turn the call over to Mike.

Mike Morrissey – President and Chief Executive Officer

Okay, thank you Charles and thanks everyone joining us on the call today. Fourth quarter of 2011 and the first six weeks of 2012 have been very productive for Exelixis. We continue to maintain our similar focus on advancing cabozantinib or cabo for short in a rationale, expeditious and cost efficient manner to further our goal to maximize its value for patients, physicians and shareholders. We are executing across all experts of the business including clinical development, manufacturing, business development, and finance.

I'll give a quick overview today to start things off and then Frank and Gisela will follow up with more details in a moment. The key takeaway message is that we have made significant progress throughout 2011 and during the last 10 weeks since our R&D Day in December. The clinical and commercial opportunity for cabozantinib is both deep and broad. As we highlighted previously, we are seeing objective partial responses per resist in 12 of 13 tumor types to-date, and we've also seen robust tumor reduction of primary and metastatic disease in lymph nodes, visceral organs, the CNS, and more recently, bone.

Our challenge is to maximize the probability of success and ultimately the commercial value of the cabozantinib franchise across the multiple tumor indications in which we have seen activity to-date. As many of you know, metastatic prostate cancer remains the primary focus of our internal clinical development activities. Metastatic CRPC is a large commercial opportunity and despite multiple recent advances provides ideal opportunities to convert cabo's unique profile into a commercially differentiated product that could potentially bring a range of clinical benefits to patients.

Our pivotal trial program in prostate cancer is designed to meaningfully differentiate cabozantinib by quantifying its potential to prolong overall survival and provide rapid and durable relief, reduction of discontinuation of narcotics, and to employ a bone scan response as a pharmacologic marker of cabo's clinical activity. No currently approved oncology agent in the CRPC space can make these claims and it's our goal to make cabo the first. We planned to achieve this goal by effectively executing our initial pivotal trials in metastatic CRPC, a process that is well underway.

As we announced at our R&D Day in December, we'll currently focus on finalizing the plans for our overall survival trial previously known as 307 study now formally named COMET-1 which stands for cabozantinib, MET inhibition, CRPC efficacy trial. We remain on track to initiate that trial in the first half of 2012. As discussed at JPMorgan in early January, we initiated the pain palliation study in December of 2011. We referred to this study in the past as the 306 study and we are now formally naming it COMET-2. Gisela will provide additional details on these prostate cancer pivotal trials in a few minutes.

As the prostate cancer clinical development program moves forward, a growing body of data for cabo and other tumor types continues to provide a signal of clinically meaningful activity. Our initial Phase 2 efforts, including the randomized discontinuation trial had successfully identified a wide range of tumor types sensitive to cabozantinib. Since late last year, investigators have made four presentations outside of the metastatic CRPC indication, specifically on differentiated thyroid cancer, metastatic breast cancer, liver cancer, and most recently advanced renal cell carcinoma.

Read the rest of this transcript for free on seekingalpha.com