Conference Call and Webcast
Exelixis' management will discuss the company's financial results for the quarter and year ended December 31, 2012, financial outlook, and development program and plans for COMETRIQ, and will also provide a general business update, during a conference call beginning at 5:00 p.m. EST/2:00 p.m. PST today, Thursday, February 21, 2013. To listen to a live webcast of the discussion, visit the Event Calendar page under Investors & Media at
An archived replay of the webcast will be available on the Event Calendar page under Investors & Media at
and via phone until 11:59 p.m. PST on March 21, 2013. Access numbers for the phone replay are: 888-286-8010 (domestic) and 617-801-6888 (international); the passcode is 32648982.
Exelixis, Inc. is a biotechnology company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its proprietary resources and development efforts exclusively on its lead product, COMETRIQ. Exelixis has also established a portfolio of other novel compounds that it believes have the potential to address serious unmet medical needs, many of which are being advanced by partners as part of collaborations. For more information, please visit the company's web site at
Basis of Presentation
Exelixis adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal year ended December 28, 2012 are indicated on a calendar year basis, ended December 31, 2012, and references as of and for the fiscal quarters ended December 30, 2011 and December 28, 2012 are indicated as ended December 31, 2011 and 2012, respectively. Fiscal year 2013, a 52-week year, will end on December 27, 2013.
This press release contains forward-looking statements, including, without limitation, statements related to: the referenced review for marketing authorization for COMETRIQ in the European Union; Exelixis' plans to initiate phase 3 pivotal trials of cabozantinib in advanced HCC and metastatic RCC; Exelixis' focus on expanding the commercial franchise for cabozantinib; Exelixis' primary objective to execute on the broad cabozantinib clinical development program, including Exelixis' COMET pivotal trial program in metastatic CRPC, planned pivotal trials in HCC and RCC, and additional randomized phase 2 trials; the continued development, clinical, therapeutic and commercial potential of COMETRIQ; and Exelixis' financial outlook for 2013, including expected contract and license revenue, total costs and expenses, including non-cash expenses, interest expense, including non-cash charges and 2013 year-end cash and cash equivalents, short- and long-term investments and short- and long-term restricted cash and investments balance. Words such as “confirms,” “permit,” “review,” “plans,” “initiate,” “focus,” “primary objective,” “continue,” “allow,” “potential,” “outlook,” “expects,” “believes,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis' current plans, assumptions, beliefs and expectations. Forward-looking statements involve risks and uncertainties. Exelixis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; the uncertain timing and level of expenses associated with the development of cabozantinib; Exelixis' ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; the availability of data at the expected times; the risk that unanticipated developments could adversely affect the launch, commercialization, manufacturing, distribution and availability of COMETRIQ; the degree of market acceptance of COMETRIQ; the extent to which coverage and reimbursement for COMETRIQ will be available from third-party payors; risks and uncertainties related to Exelixis' compliance with applicable regulatory requirements, including healthcare fraud and abuse laws and post-marketing requirements; Exelixis' dependence on third-party vendors; timely receipt of potential reimbursements, milestones, royalties and profits under Exelixis' collaborative agreements; the sufficiency of Exelixis' capital and other resources; the uncertainty of the regulatory approval processes; market competition; and changes in economic and business conditions. These and other risk factors are discussed under “Risk Factors” and elsewhere in Exelixis' annual report on Form 10-K for the year ended December 28, 2012, filed with the Securities and Exchange Commission (SEC) on February 21, 2013, and Exelixis' other filings with the SEC. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.