Exelixis CEO Discusses Q3 2010 Results - Earnings Call Transcript
Exelixis, Inc. (
)
Q3 2010 Earnings Call
November 04, 2010 5:00 pm ET
Executives
Mike Morrissey - President and CEO
Frank Karbe - CFO
Analysts
Ted Tenthoff - Piper Jaffray
Ziad Bakri - Cowen & Company
Joel Sendek - Lazard Capital Markets
Presentation
Operator
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Exelixis, Inc. Q2 2010 Earnings Call Transcript
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Exelixis, Inc. Q1 2010 Earnings Call Transcript
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Exelixis, Inc. Q3 2009 Earnings Call Transcript
Good day, ladies and gentlemen, and welcome to the third quarter 2010 Exelixis earnings conference call. My name is Kares and I will be your coordinator for today. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session. (Operator Instructions)
I would now like to turn the call over to your host for today, Mr. Charles Butler, Vice President of Investor Relations. Please proceed, sir.
Charles Butler
Thank you. Thank you for joining us on the Exelixis third quarter 2010 earnings call. Joining me on today's call are Mike Morrissey, our new President and CEO; Frank Karbe, our CFO who will review our corporate, financial, and development progress for the quarter ended October 1, 2010. They will also discuss upcoming objectives and provide an update on 184, our lead clinical development program. As a reminder, we are reporting our financial results on a GAAP basis only and as usual, the complete press release with our results can be accessed through our website at exelixis.com.
Before we get started, I would like to note that during our presentation and question-and-answer session today, we will be making certain statements that are forward-looking, including without limitation statements related to the future development of 184 and our plans related there to, the clinical, therapeutic and commercial potential of 184, future presentations on data and development priorities, and our 2010 financial outlook.
These statements are only predictions and are based upon current assumptions and expectations. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements because of risks and uncertainties discussed in the presentation materials, the comments made during this presentation, and the Q&A session, and the Risk Factors section of our 10-Q for the quarter ended October 1, 2010, and our other reports filed with the Securities and Exchange Commission. We expressly disclaim any duty to make any updates or revisions to any forward-looking statement.
With that, I will turn the call over to Mike Morrissey.
Mike Morrissey
Thank you Charles and thanks to everyone joining us on the call today. We’ve had a productive quarter and made progress across nearly all aspects of our business. Our call today is taking place ahead of the EORTC data release for XL184 in two weeks. We’ll focus our brief comments today on XL184; the Q4 events that will help us end the year and our Q3 financial summary, including our recently announced transaction with BMS.
(inaudible) saying that 2010 has been a truly transformative year for Exelixis and we continue to focus on two key objectives, developing new oncology drugs for cancer patients with significant unmet medical need and building value for our shareholders. Let’s first start today with XL184.
Our development activities with this compound remain the top priority for the company. We are advancing the XL184 clinical program across multiple fronts and are evaluating 13 tumor types across eight clinical trials in the initial development effort. Today, objective responses have been seen in seven distinct tumor types thus demonstrating the potential of XL184 as a broadly acting anti cancer agent.
In addition to the activity observed in patients with advanced medullary thyroid cancer or MTC and refractory glioblastoma, objective responses were documented at ASCO and patients with five other tumor types from our ongoing randomized discontinuation trial or RDT study including advanced ovarian cancer with 3PRs hepatoma, with 2PRs patients after progression of sorafenib and non small cell lung cancer also with 2PRs.
The pivotal phase III trial of XL184 in MTC patients is projected to read out top line data in the first half of 2011 and we planned to file our first NDA in the second half of 2011 assuming a positive outcome of that trial. In addition, we are preparing to initiate a phase II pivotal trial in refractory glioblastoma patients in the fourth quarter based on the encouraging data that was presented at ASCO in June.
The RDT study is an important single search trial that is investigating the activity of XL184 in nine different tumor types. This study will be the focus of our six upcoming presentations at the EORTC meeting on November 18 in Berlin and our R&D day on December 2 in New York City. We will have a closer presentation on the overall study results as well as individual posters with the new data from hepatoma, prostate, ovarian, melanoma, and non small cell lung cancer. We are planning report data on approximately 40 to 60 valuable patients for the later four cohorts.
Rapid enrollment into the RDT study continues and is now at 400 patients overall. This we believe reflects investigative enthusiasm for the trial and the emerging data obtained so far. Of these five tumor types, metastatic castration-resistant prostate cancer is evolving into an opportunity of significant interest. We have enrolled 101 patients into the prostate cohort to-date including 59 patients since September 1
st
.
Investigators interest were peaked by our initial data released during ASCO which documented a single post Taxotere patients who experienced a truly unique clinical response to XL184. A complete resolution of the bone scan at 6 and 12 weeks confirm partial response of this measurable lung lesion, a 50% decrease in its PSA level and a marked reduction in the symptomatic pain that is often associated with bone metastasis.
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