\nExelixis, Inc. (Nasdaq: EXEL) today reported financial results for the first quarter of 2023 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones.<\/p>\n
\n\u201cThe Exelixis team continued to execute on our key priorities and made significant progress in advancing our commercial business and our growing pipeline,\u201d said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. \u201cCABOMETYX\u00ae<\/sup> maintained its status as the leading tyrosine kinase inhibitor in renal cell carcinoma in the first quarter, driven by its use in combination with nivolumab in the first-line setting. We\u2019ve made important progress across our pipeline programs, including advancing the STELLAR-303 and STELLAR-304 phase 3 trials for zanzalintinib, as well as single-agent and combination dose-escalation cohorts of the phase 1 trial of XB002. We are on track to initiate additional pivotal studies for zanzalintinib in 2023 and are focused on accelerating XB002 into full development by year-end.\u201d<\/p>\n \nDr. Morrissey continued: \u201cOur collaborations with Cybrexa and Sairopa also made steady progress. Sairopa received clearance of its Investigational New Drug application for ADU-1805 from the U.S. Food and Drug Administration in February and subsequently initiated the phase 1 study in March. Cybrexa is planning to present updated phase 1 data for CBX-12 at the ASCO Annual Meeting in June. In March, we announced a share repurchase program for up to $550 million of our common stock before the end of 2023, which reflects continued confidence in our long-term prospects and the strength of our balance sheet and reinforces our commitment to deliver value to shareholders. I\u2019d like to thank the entire Exelixis team for their collective hard work and dedication to improving the standard-of-care for patients while driving sustainable, long-term value for shareholders as we advance our mission to help cancer patients recover stronger and live longer.\u201d<\/p>\n First Quarter 2023 Financial Results<\/span><\/b><\/p>\n Total revenues <\/b>for the quarter ended March 31, 2023 were $408.8 million, as compared to $356.0 million for the comparable period in 2022.<\/p>\n \nTotal revenues for the quarter ended March 31, 2023 included net product revenues of $363.4 million, as compared to $310.3 million for the comparable period in 2022. The increase in net product revenues was primarily due to an increase in sales volume and an increase in average net selling price.<\/p>\n \nCollaboration revenues, composed of license revenues and collaboration services revenues, were $45.4 million for the quarter ended March 31, 2023, as compared to $45.7 million for the comparable period in 2022. The decrease in collaboration revenues was primarily related to a decrease in development cost reimbursements earned, which was offset by higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis\u2019 collaboration partners, Ipsen Pharma SAS and Takeda Pharmaceutical Company Limited.<\/p>\n Research and development expenses<\/b> for the quarter ended March 31, 2023 were $234.2 million, as compared to $156.7 million for the comparable period in 2022. The increase in research and development expenses was primarily related to increases in license and other collaboration costs, personnel expenses and manufacturing costs to support our development candidates, which were partially offset by lower stock-based compensation expense.<\/p>\n Selling, general and administrative expenses<\/b> for the quarter ended March 31, 2023 were $131.4 million, as compared to $102.9 million for the comparable period in 2022. The increase in selling, general and administrative expenses was primarily related to an increase in personnel expenses.<\/p>\n Provision for income taxes <\/b>for the quarter ended March 31, 2023 was $8.3 million, as compared to $16.7 million for the comparable period in 2022, primarily due to a decrease in pre-tax income.<\/p>\n GAAP net income <\/b>for the quarter ended March 31, 2023 was $40.0 million, or $0.12 per share, basic and diluted, as compared to GAAP net income of $68.6 million, or $0.21 per share, basic and diluted, for the comparable period in 2022.<\/p>\n Non-GAAP net income <\/b>for the quarter ended March 31, 2023 was $52.8 million, or $0.16 per share, basic and diluted, as compared to non-GAAP net income of $83.9 million, or $0.26 per share, basic and diluted, for the comparable period in 2022.<\/p>\n Non-GAAP Financial Measures<\/span><\/b><\/p>\n \nTo supplement Exelixis\u2019 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 (and the related per share measures) stock-based compensation expense, adjusted for the related income tax effect for all periods presented.<\/p>\n \nExelixis 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\u2019 and analysts\u2019 ability to meaningfully compare Exelixis\u2019 results from period to period, and to identify operating trends in Exelixis\u2019 business. Exelixis has excluded stock-based compensation expense, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.<\/p>\n \nThese non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis\u2019 business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.<\/p>\n 2023 Financial Guidance<\/span><\/b><\/p>\n \nExelixis is maintaining the previously provided financial guidance for fiscal year 2023:<\/p>\n
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