Key Takeaways
- • Exelixis reported Q3 2026 total revenues of $658.7M, up from $597.8M a year earlier, driven by net product revenues of $604.9M (vs. $542.9M).
- • GAAP net income rose to $218.1M ($0.85 per diluted share) from $193.6M ($0.69), aided by lower share count from stock repurchases; non-GAAP net income was $240.2M ($0.94 diluted).
- • The FDA set a March 3, 2027 PDUFA date for zanzalintinib plus atezolizumab in previously treated metastatic colorectal cancer after a three-month review extension.
- • Phase 3 STELLAR-304 (nccRCC) topline results are expected in Q1 2027; STELLAR-316 in resected CRC with Merck and Natera began enrolling in August 2026.
- • Exelixis is actively evaluating external innovation opportunities while continuing share repurchases and R&D investment.
Summary
Exelixis, Inc. (Nasdaq: EXEL) reported third-quarter 2026 results for the quarter ended September 30, 2026, with total revenues of $658.7M compared with $597.8M in the year-earlier period. Net product revenues, driven primarily by higher sales volume and a higher average net selling price, rose to $604.9M from $542.9M. Collaboration revenues were $53.8M versus $54.8M, as lower milestone revenues and development cost reimbursements were partly offset by higher royalties on cabozantinib sales outside the U.S. generated by partner Ipsen. Exelixis earned $51.8M in royalty revenues from Ipsen and Takeda's cabozantinib sales in the quarter.
Operating expenses increased. Research and development expenses rose to $209.5M from $199.2M on higher personnel and clinical trial costs. Selling, general and administrative expenses climbed to $154.6M from $123.7M, reflecting personnel, marketing, and legal and advisory costs. Provision for income taxes was $64.7M versus $58.8M. GAAP net income was $218.1M, or $0.88 basic and $0.85 diluted per share, compared with $193.6M and $0.69 diluted per share a year earlier. The company attributed the per-share improvement partly to lower weighted-average shares outstanding from its stock repurchase programs. Non-GAAP net income, which excludes stock-based compensation net of tax effects, was $240.2M, or $0.94 per diluted share.
On the regulatory front, the U.S. FDA is reviewing the NDA for zanzalintinib in combination with atezolizumab for previously treated metastatic CRC, with a PDUFA target action date of March 3, 2027. In September 2026, the agency extended the review by three months after Exelixis submitted updated safety and efficacy data in response to an information request. The NDA is based on the phase 3 STELLAR-303 trial, where overall survival met one dual primary endpoint in the intention-to-treat population. In June 2026, Exelixis reported that the non-liver metastases subpopulation showed a non-statistically significant OS trend favoring the combination; detailed findings are planned for a future medical conference. Guidance does not include potential zanzalintinib launch revenue.
Pipeline activity included the August 2026 initiation of phase 3 STELLAR-316, which is evaluating zanzalintinib with and without KEYTRUDA QLEX in resected stage II/III CRC patients who are MRD+. Merck supplies KEYTRUDA QLEX and Natera provides its Signatera assay for enrollment. Exelixis expects topline results from phase 3 STELLAR-304 in nccRCC in Q1 2027. Phase 3 LITESPARK-033 and LITESPARK-034, Merck-sponsored trials evaluating zanzalintinib with WELIREG, are enrolling. CEO Michael M. Morrissey, Ph.D., said the company remains disciplined in capital deployment across R&D, share repurchases, and external innovation opportunities.
Operating expenses increased. Research and development expenses rose to $209.5M from $199.2M on higher personnel and clinical trial costs. Selling, general and administrative expenses climbed to $154.6M from $123.7M, reflecting personnel, marketing, and legal and advisory costs. Provision for income taxes was $64.7M versus $58.8M. GAAP net income was $218.1M, or $0.88 basic and $0.85 diluted per share, compared with $193.6M and $0.69 diluted per share a year earlier. The company attributed the per-share improvement partly to lower weighted-average shares outstanding from its stock repurchase programs. Non-GAAP net income, which excludes stock-based compensation net of tax effects, was $240.2M, or $0.94 per diluted share.
On the regulatory front, the U.S. FDA is reviewing the NDA for zanzalintinib in combination with atezolizumab for previously treated metastatic CRC, with a PDUFA target action date of March 3, 2027. In September 2026, the agency extended the review by three months after Exelixis submitted updated safety and efficacy data in response to an information request. The NDA is based on the phase 3 STELLAR-303 trial, where overall survival met one dual primary endpoint in the intention-to-treat population. In June 2026, Exelixis reported that the non-liver metastases subpopulation showed a non-statistically significant OS trend favoring the combination; detailed findings are planned for a future medical conference. Guidance does not include potential zanzalintinib launch revenue.
Pipeline activity included the August 2026 initiation of phase 3 STELLAR-316, which is evaluating zanzalintinib with and without KEYTRUDA QLEX in resected stage II/III CRC patients who are MRD+. Merck supplies KEYTRUDA QLEX and Natera provides its Signatera assay for enrollment. Exelixis expects topline results from phase 3 STELLAR-304 in nccRCC in Q1 2027. Phase 3 LITESPARK-033 and LITESPARK-034, Merck-sponsored trials evaluating zanzalintinib with WELIREG, are enrolling. CEO Michael M. Morrissey, Ph.D., said the company remains disciplined in capital deployment across R&D, share repurchases, and external innovation opportunities.
Go deeper than the headline
Research every firm in this story, track the ones that matter and get the daily briefing — free for 7 days.