Exelixis, Inc. (EXEL)
Q2 2010 Earnings Call Transcript
August 5, 2010 5:00 pm ET
Charles Butler – VP, Corporate Communications & IR
Michael Morrissey – President and CEO
Frank Karbe – EVP and CFO
Joel Sendek – Lazard Capital Markets
Ted Tenthoff – Piper Jaffray
George Farmer – Canaccord
Good day, ladies and gentlemen, and welcome to the second quarter 2010 Exelixis earnings conference call. My name is Amanda and I will be your coordinator for today. At this time, all participants are in a listen-only mode. We will facilitate a question-and-answer session towards the end of today's conference. (Operator Instructions)
At this time, I would like to turn the call over to your host for today, Mr. Charles Butler, Vice President of Investor Relations. Please proceed, sir.
So thank you for joining us on the Exelixis second quarter 2010 earnings call. Joining me on today's call are Mike Morrissey, our new President and CEO; Frank Karbe, our CFO who will both jointly review our corporate, financial, and development progress for the quarter ended June 30, 2010. They will also discuss upcoming objectives and provide an update on XL184, 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 this presentation and question-and-answer session today, we will be making certain statements that are forward-looking, including and without limitation statements related to the future development of XL184 and our plans related to HER2 [ph], the therapeutic and commercial potential of XL184, data to be presented at EORTC in November 2010, expectations regarding development activities, 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 July 2nd, 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.
Thanks, Charles and thanks to everyone joining us on the call today. As most of you know, I officially became CEO of Exelixis just over two weeks ago on July 15th. I'm taking this position at a turbulent time and I'm excited to lead the company with a clear sense of focus, urgency, and transparency as we advance our key compounds into late-stage development and potential commercialization.
The stability of our senior management and the collaborative approach of our Board remain at the core of the company. We have been working together as a team for many years and we will continue to do so. Despite our recent challenges, we remain focused on advancing XL184, which has generated encouraging early clinical data in a variety of tumor types, including some with significant commercial potential.
While we have numerous other compounds advancing in the clinic, including the PI3K inhibitors XL147 and XL765 with sanofi, our most important near-term objective is to generate additional clinical data that will enable us to concisely frame the near-term development and commercial opportunities for XL184.
While we readily acknowledge the concerns that are shared by many investors about regaining the rights to XL184, we are optimistic that this compound can serve as a potential catalyst for building positive momentum as new data become available from the randomized discontinuation trial or RDT study in the fall.
I'll state here and now that we are moving forward with a renewed sense of urgency and commitment in order to execute on our key next steps in a thoughtful and pragmatic manner.
We made significant progress on the XL184 development program since our most recent update in June. Our near-term plans, which we presented at ASCO, are based on sound clinical developments and commercial rationale and consist of three main priorities.
First, the RDT study continues to enroll quickly, which we believe reflects a high level of investigator enthusiasm for the study. We have expanded enrollment in the hepatoma, melanoma, non-small cell lung cancer, ovarian and prostate cancer cohorts.
Key elements of the early clinical activity highlighted at ASCO including the improvement of bone scans in patients with metastatic castration-resistant prostate cancer are potentially novel and differentiating compared to other TKIs and/or standard of care and continue to be of big interest to us and our investigators as this broad dataset has grown since ASCO.
We are planning an updated presentation of the expanded RDT data at the upcoming EORTC meeting in November where six abstracts have been accepted. We hope to frame our 2011 development priorities and plans for XL184 at our R&D Day on December 2nd.
Second, we inspect – we expect to initiate a Phase III pivotal trial in recurrent glioblastoma with single agent XL184 by the end of 2010 based on the encouraging IRF confirmed response rate of 30% and the median duration of response of 5.1 months, highlighted in an oral presentation at ASCO in June.
Third, we continue to actively enroll our Phase III pivotal trial in medullary thyroid cancer on a global basis and diligently focus on key activities to support a potential filing of our first NDA in MTC in the second half of 2011.