Exelixis ( EXEL) Q3 2011 Results October 27, 2011 5:00 p.m. ET Executives Charles Butler – VP, IR Mike Morrissey – President and CEO Frank Karbe – EVP and CFO Gisela Schwab – EVP and Chief Medical Officer Scott Garland - EVP and Chief Commercial Officer Analysts Ted Tenthoff - Piper Jaffray Karen Jay - JP Morgan George Farmer - Canaccord David Miller - Biotech Stock Research Ryan Martins - Lazard Capital Markets Eric Schmidt – Cowan & Company Maged Shenouda - Stifel Nicolaus Presentation Operator
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As a reminder, during this call we will making certain forward-looking statements that are forward-looking, including, without limitations, statements related to our updated 2011 financial guidance, our plans to build value for patients and shareholders; the continued development and clinical, therapeutic, and commercial potential of, and opportunities for, Cabozantinib; the expected timing of the initiation of the planned XL184306 pivotal trial of Cabozantinib in metastatic castration-resistant prostate cancer; additional planned Phase III pivotal trials in prostate cancer; our plans to file a new drug application for Cabozantinib in medullary thyroid cancer and the timing of the FDA’s response thereto; and upcoming data presentations for Cabozantinib as well as other statements identified as forward-looking in the slides accompanying this call.These statements are only predictions and are based upon our current assumptions and expectations. Our actual result and the timing of events could differ materially from those anticipated in such forward-looking statements because of risk and uncertainty discussed in the slides accompanying this call, the comments made during this call, and the risk factor section of our 10-Q for the quarter ended September 30, 2011, 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 statements. And with that, I’ll turn the call over to Mike. Mike Morrissey Thank you Charles, and thanks to everyone joining us on the call today. We’ve had a very exciting week and are moving forward to build momentum from the outstanding results we have attained in the EXAM study. Based on that data, it’s clear that Cabozantinib’s significant antitumor activity translates into a profound PFS benefit in patients with advanced MTC. We’re thrilled with the EXAM data and its implications and will continue to move thoughtfully and aggressively to build value for both patients and shareholders.
We have a number of important topics to discuss today including first, our Q3 financial results that Frank will discuss shortly; second, the top line EXAM results that we released on Monday; third, a brief update on the 306 SPA process; and finally a review of additional upcoming data presentations in Q4.Now I know that everyone has a lot of questions on EXAM and the supporting data that led to the top line results we disclosed on Monday. As I’m sure you’ll appreciate, we’re not going to dive into the details on EXAM today as we’re continuing to review the broad EXAM data set and do not want to jeopardize a future presentation and publication at a top-tier medical meeting and journal by sharing data beyond the top line information we disclosed on Monday. As you know, we submitted the 306 SPA documents to the FDA in June 2011. We expect to get feedback from the FDA shortly on the 306 protocol and its acceptability to support a regulatory filing in metastatic CRPC if the resulting data are positive. We will communicate this information publicly as soon as we have completed the SPA process. In the meantime, we are actively planning to initiate the 306 study this year and have selected clinical trial sites and vendors to enable an expeditious start before the end of 2011. We remain confident that we will secure a SPA for 306 that will allow for a robust investigation of the potential clinical benefit of Cabozantinib in an indication with substantial commercial potential. As we outlined a few minutes ago for the EXAM trial, we’re not going to delve into the details of the 306 protocol or entertain detailed questions on the SPA process today as to not preempt agency feedback on this topic. Finally, we also announced this week that Scott Garland joined our executive team as EVP and chief commercial officer. With 20 years of sales and marketing experience in both Big Pharma and biotech, Scott comes to Exelixis from Genentech, where, since 2009, he served as vice president of the Avastin franchise, the largest product at Genentech and one of the top five global oncology products. Scott provides the additional domain expertise, experience, and perspective that we need to advance Cabozantinib as a leading oncology franchise. Read the rest of this transcript for free on seekingalpha.com