Earnings release
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EXELIXIS Exelixis Announces Third Quarter 2021 Financial Results and Provides Corporate Update November 2 , 2021 - Total Revenues of $ 328.4 Million , Cabozantinib Franchise Revenues of $ 263.1 Million - -GAAP Diluted EPS of $ 0.12 , Non - GAAP Diluted EPS of $ 0.20 - - Conference Call and Webcast Today at 5:00 PM Eastern Time - ALAMEDA , Calif .-- ( BUSINESS WIRE ) -- Nov . 2 , 2021-- Exelixis , Inc. ( Nasdaq : EXEL ) today reported financial results for the third quarter of 2021 and provided an update on progress toward achieving key corporate objectives , as well as commercial , clinical and pipeline development milestones . " Exelixis continued to execute across all facets of our business in the third quarter of 2021 with significant progress across our commercial , clinical development and pipeline activities , " said Michael M. Morrissey , Ph.D. , President and Chief Executive Officer , Exelixis . " We are pleased with the growth of CABOMETYXⓇ prescriptions in the third quarter in the face of increasing competition , driven by the continued broad adoption of the CABOMETYX and OPDIVOⓇ combination regimen in first - line renal cell carcinoma . Additionally , in September , CABOMETYX was approved by the U.S. Food and Drug Administration for a differentiated thyroid cancer indication , further expanding the CABOMETYX label to add an important new treatment option for a patient population with significant unmet need . We also made important strides across our clinical pipeline during the quarter , including expanding our XL092 development program and progressing enrollment for our XB002 and XL102 phase 1 studies . More recently , following the FDA's acceptance of the Investigational New Drug application for XL114 , we in - licensed the compound from Aurigene . Additionally , we signed a new collaboration agreement with STORM Therapeutics for a novel therapeutic approach to treat cancer . I'd like to thank the Exelixis team for their collective hard work and execution in the third quarter and look forward to providing further updates on our business in the remainder of the year . ” Third Quarter 2021 Financial Results Total revenues for the quarter ended September 30 , 2021 were $ 328.4 million , compared to $ 231.1 million for the comparable period in 2020 . Total revenues for the quarter ended September 30 , 2021 included net product revenues of $ 263.1 million , compared to $ 168.6 million for the comparable period in 2020. The increase in net product revenues was primarily related to an increase in sales volume that was driven by strong uptake for the combination therapy of CABOMETYX ( cabozantinib ) and OPDIVO ( nivolumab ) following approval by the U.S. Food and Drug Administration ( FDA ) in January 2021 . Collaboration revenues , composed of license revenues and collaboration services revenues , were $ 65.3 million for the quarter ended September 30 , 2021 , compared to $ 62.5 million for the comparable period in 2020. The increase in collaboration revenues was primarily related to an increase in recognition of milestone - related revenues and higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis ' collaboration partners , Ipsen Pharma SAS ( Ipsen ) and Takeda Pharmaceutical Company Limited ( Takeda ) , which was partially offset by a decrease in development costs reimbursements earned . Research and development expenses for the quarter ended September 30 , 2021 were $ 163.4 million , compared to $ 176.8 million for the comparable period in 2020. The decrease in research and development expenses was primarily related to decreases in clinical trial costs , license and other collaboration costs and stock - based compensation expense , which was partially offset by an increase in personnel expenses . Selling , general and administrative expenses for the quarter ended September 30 , 2021 were $ 101.6 million , compared to $ 88.2 million for the comparable period in 2020. The increase in selling , general and administrative expenses was primarily related to increases in personnel expenses , marketing costs and corporate giving , which was partially offset by a decrease in stock - based compensation expense . Provision for ( benefit from ) income taxes for the quarter ended September 30 , 2021 was $ 15.1 million , compared to $ ( 6.0 ) million for the comparable period in 2020 , primarily due to the change in pre - tax income ( loss ) . GAAP net income ( loss ) for the quarter ended September 30 , 2021 was $ 38.2 million , or $ 0.12 per share , basic and diluted , compared to GAAP net loss of $ ( 32.0 ) million , or $ ( 0.10 ) per share , basic and diluted , for the comparable period in 2020 . Non - GAAP net income for the quarter ended September 30 , 2021 was $ 64.5 million , or $ 0.20 per share , basic and diluted , compared to non - GAAP net income of $ 11.2 million , or $ 0.04 per share , basic and diluted , for the comparable period in 2020. Non - GAAP net income excludes stock - based compensation , adjusted for the related income tax effect . Cash , cash equivalents , restricted cash equivalents and investments were $ 1.8 billion at September 30 , 2021 , compared to $ 1.5 billion at December 31 , 2020 . Non - GAAP Financial Measures To supplement Exelixis ' financial results presented in accordance with U.S. Generally Accepted Accounting Principles ( GAAP ) , Exelixis presents non - GAAP net income ( and the related per share measures ) , which excludes from GAAP net income ( loss ) ( and the related per share measures ) stock - based compensation expense , adjusted for the related income tax effect for all periods presented . Exelixis believes that the presentation of these non - GAAP financial measures provides useful supplementary information to , and facilitates additional analysis by , investors . In particular , Exelixis believes that these non - GAAP financial measures , when considered together with its financial information prepared in accordance with GAAP , can enhance investors ' and analysts ' ability to meaningfully compare Exelixis ' results from period to period , and to identify operating trends in Exelixis ' business . Exelixis has excluded stock - based compensation expense , adjusted for the related income tax effect ,