Previous Statements by EXEL
» Exelixis CEO Presents at Goldman Sachs Healthcare Conference (Transcript)
» Exelixis' Management Presents at Bank of America Merrill Lynch 2012 Health Care Conference (Transcript)
» Exelixis' Management Presents at Deutsche Bank Securities Annual Health Care Conference (Transcript)
» Exelixis's CEO Discusses Q1 2012 Results - Earnings Call Transcript
As a reminder, during the course of this presentation, we will be making forward-looking statements regarding future events or future performance of the company. Including statements about possible future developments regarding clinical regulatory, commercial, financial and strategic matters, 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 today August 2, 2012. These documents contain and identify under the heading Risk Factors, important factors 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 that 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. With that, I will turn the call over to Mike. Mike Morrissey Okay. Thank you, Charles, and thank you all for joining us on the call today. We had a very busy second quarter, and I’d like to briefly highlight our key achievements for Q2 and our goals for the second half of 2012. First, we reached the critical milestone of completing our first NDA submission for cabozantinib for the treatment of progressive Medullary Thyroid Cancer or MTC. This is an important achievement for our company and for the cabozantinib franchise, which we believe has substantial clinical and commercial potential, we also advanced other aspects of the cabozantinib development program including the presentation of nine abstracts at the 2012 ASCO Annual Meeting in June and the expansion of our CRADA with the MCI. As you would expect, we won’t be able to say a lot today about the cabozantinib MTC NDA submission. We’re pleased to have received priority review for the application and we’re working diligently with the agency to facilitate the review process. We had a prominent role at ASCO this year, where we presented the latest data for cabo in eight different tumor indications.
We believe this year’s ASCO data helps to find the broad clinical potential with cabo as a differentiated oncology drug. The data presented for the MTC pivotal trial exam and the two prostate cancer aspects covering the non-randomized expansion cohorts and a low dose IST for Mass General were well received. We have talked previously about our view that cabo is more is just a prostate cancer drug and more just a bone targeting drug.Key ASCO data for cabo including renal cancer, liver cancer, non-small cell lung cancer, melanoma and breast cancer help to reinforce this perspective, with encouraging progression-free survival data and in some cases overall survival data, and we’re viewed positively by key oncology investigators, as we potentially differentiated compared to other commonly used agents dose indications. Collectively, these data showed robust signs of clinical activity that support the expansion of the cabo development program already underway with CTEP. With our singular focus on cabozantinib, we have a clear set of priorities that will support the continued progress of the cabo throughout the second half of 2012, including facilitating the cabo MTC, NDA review, expediting the COMET trials and advancing the cabozantinib IST and CTEP programs. We obviously have a lot on our plate right now and our focus remains solely on driving cabo forward as quickly and as broadly as possible. Gisela will discuss some of these topics in further detail in a moment, but first, I’ll turn the call over to Frank, who will provide an overview for our second quarter financials. Frank. Frank Karbe Thanks, Mike. As usual I will focus my comments on the highlights of our financial performance, and refer you to our press release and today’s 10-Q filing for additional details. In summary our Q2 financial performance was pretty much in line with the financials from the first quarter of this year. Read the rest of this transcript for free on seekingalpha.com