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Exelixis, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 5 August 2026: press release. Guidance figures: 3 lowered, 4 kept. The quarter’s numbers.

Key takeaways

  • Total revenue rose year on year: Total revenues were $628.7 million, against $568.3 million a year earlier and $610.8 million in the first quarter of 2026. Source
  • GAAP and non-GAAP EPS reported: GAAP net income was $212.1 million, or $0.82 per diluted share, against $0.65 a year earlier. Non-GAAP diluted EPS was $0.91, excluding stock-based compensation. Source
  • CABOMETYX drove U.S. sales: CABOMETYX net product revenues were $570.6 million and COMETRIQ net product revenues were $2.4 million, totaling $573.0 million in the U.S. Source
  • Colorectal NDA under FDA review: The FDA is reviewing the NDA for zanzalintinib with atezolizumab in previously treated metastatic colorectal cancer. The PDUFA target action date is December 3, 2026. Source
  • Non-liver subgroup survival trend: The final NLM subgroup overall survival analysis from STELLAR-303, announced in June 2026, showed a trend favoring the combination that was not statistically significant. Source
  • Revenue guidance lowered: Total revenue guidance is $2.500 billion to $2.550 billion, down from $2.525 billion to $2.625 billion. Net product revenue guidance is $2.300 billion to $2.350 billion, down from $2.325 billion to $2.425 billion. Source
  • Q2 buybacks totaled $311.6 million: The company repurchased $311.6 million of stock in the quarter at an average of $47.85 per share, and completed the October 2025 program of $750 million. Source

“Exelixis continues to execute across the key pillars of our business, positioning the company to deliver on our strategic objectives for 2026 and beyond,”

Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis

Guidance

AreaPeriodFigureAgainst last quarter
Total revenues SourceFiscal year 2026$2.500 billion - $2.550 billionLowered from $2.525 billion - $2.625 billion
Net product revenues SourceFiscal year 2026$2.300 billion - $2.350 billionLowered from $2.325 billion - $2.425 billion
Cost of goods sold, % of net product revenues SourceFiscal year 20263.5% - 4.5%Kept
Research and development expenses SourceFiscal year 2026$825 million - $875 millionLowered from $875 million - $925 million
Selling, general and administrative expenses SourceFiscal year 2026$575 million - $625 millionKept
Effective tax rate SourceFiscal year 202621% - 23%Kept
Stock repurchases (May 2026 SRP) SourceThrough December 31, 2027up to $750 millionKept

What changed from last quarter

  • Guidance lowered: Full-year total revenue guidance and net product revenue guidance were both lowered from the January 11, 2026 ranges. Source
  • Guidance lowered: Full-year R&D expense guidance was lowered from $875 million to $925 million to $825 million to $875 million. Source
  • New: Merck agreed to supply KEYTRUDA QLEX for the planned STELLAR-316 trial, announced in May 2026. The first quarter release did not include this supply arrangement. Source
  • New: The final analysis of overall survival in the NLM subgroup of STELLAR-303 was announced in June 2026, a result not reported in the first quarter release. Source
  • Ended: The October 2025 stock repurchase program was completed in the second quarter, with the $750 million commitment fulfilled. Source

Revenue and profit results

  • Total revenue rose year on year: Total revenues were $628.7 million, against $568.3 million a year earlier and $610.8 million in the first quarter of 2026. Source
  • Product sales grew on volume: Net product revenues were $573.0 million, against $520.0 million a year earlier. The company attributed the increase primarily to higher sales volume. Source
  • GAAP and non-GAAP EPS reported: GAAP net income was $212.1 million, or $0.82 per diluted share, against $0.65 a year earlier. Non-GAAP diluted EPS was $0.91, excluding stock-based compensation. Source
  • Fewer shares lifted per-share results: Management said per-share results were favorably impacted by lower weighted-average shares outstanding from the stock repurchase programs. Diluted shares averaged 259.7 million. Source

Cabozantinib franchise and royalties

  • CABOMETYX drove U.S. sales: CABOMETYX net product revenues were $570.6 million and COMETRIQ net product revenues were $2.4 million, totaling $573.0 million in the U.S. Source
  • Partner royalties rose: Royalty revenues from partner sales of cabozantinib were $53.2 million, up from $45.9 million in the first quarter. Partners are Ipsen and Takeda. Source
  • Collaboration revenue rose on royalties: Collaboration revenues were $55.7 million, against $48.2 million, mainly from higher ex-U.S. royalties, partly offset by lower development cost reimbursements. Source

“Additionally, in the second quarter, we saw the continued growth of the cabozantinib franchise while advancing preparations for the potential launch of zanzalintinib in metastatic colorectal cancer, pending approval from regulatory authorities later this year.”

Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis

Zanzalintinib regulatory and trial progress

  • Colorectal NDA under FDA review: The FDA is reviewing the NDA for zanzalintinib with atezolizumab in previously treated metastatic colorectal cancer. The PDUFA target action date is December 3, 2026. Source
  • Non-liver subgroup survival trend: The final NLM subgroup overall survival analysis from STELLAR-303, announced in June 2026, showed a trend favoring the combination that was not statistically significant. Source
  • STELLAR-304 readout in second half: Topline results from STELLAR-304 in non-clear cell renal cell carcinoma are expected in the second half of 2026, depending on event rates. Primary endpoints are PFS and ORR. Source
  • STELLAR-316 start on track: The phase 3 STELLAR-316 trial in resected stage II/III colorectal cancer is on track to start in mid-2026, with Natera supplying its Signatera assay for enrollment. Source
  • Other trials advancing: STELLAR-201 in recurrent meningioma is enrolling. STELLAR-311 enrollment continues. STELLAR-002 bladder and mCRPC expansion cohorts have started. Source

Partner collaborations with Merck and Natera

  • Merck to supply KEYTRUDA QLEX: Merck will supply KEYTRUDA QLEX for subcutaneous use with zanzalintinib in the STELLAR-316 trial, under a clinical development collaboration announced in May 2026. Source
  • Merck runs renal cell trials: Merck initiated LITESPARK-034 in April 2026 with zanzalintinib and WELIREG in second-line or later renal cell carcinoma. LITESPARK-033 began in December 2025. Source

“We are executing on all these initiatives while maintaining disciplined expense management and capital allocation, with a focus on simultaneously investing in R&D and returning capital to shareholders”

Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis

2026 guidance revisions

  • Revenue guidance lowered: Total revenue guidance is $2.500 billion to $2.550 billion, down from $2.525 billion to $2.625 billion. Net product revenue guidance is $2.300 billion to $2.350 billion, down from $2.325 billion to $2.425 billion. Source
  • Revenue excludes zanzalintinib launch: Revenue guidance does not reflect any revenue from a potential U.S. approval and launch of zanzalintinib for previously treated metastatic colorectal cancer. Source
  • R&D guidance lowered by $50 million: R&D expense guidance is $825 million to $875 million, down from $875 million to $925 million, and includes $50.0 million of non-cash stock-based compensation. Source
  • Cost, SG&A and tax guidance unchanged: Cost of goods sold stays at 3.5% to 4.5% of net product revenues, SG&A at $575 million to $625 million, and the effective tax rate at 21% to 23%. Source

Costs and margins

  • R&D spend rose year on year: R&D expenses were $212.0 million, up from $200.4 million, on higher clinical trial, manufacturing and license costs, partly offset by lower personnel expenses. Source
  • SG&A rose on marketing and staff: SG&A was $147.6 million, up from $134.9 million, mainly on marketing activities and personnel expenses. Source
  • Cost of goods sold edged up: Cost of goods sold was $20.7 million, up from $19.5 million a year earlier. Source
  • Tax provision rose: The provision for income taxes was $50.6 million, up from $45.6 million a year earlier, on income before taxes of $262.7 million. Source

Capital and share repurchases

  • Q2 buybacks totaled $311.6 million: The company repurchased $311.6 million of stock in the quarter at an average of $47.85 per share, and completed the October 2025 program of $750 million. Source
  • New $750 million program underway: Repurchases began under the May 2026 program, which authorizes up to $750 million through December 31, 2027. Source
  • Cumulative buybacks since 2023: Since March 2023 the company has repurchased $2.9 billion of stock, retiring 93.3 million shares at an average of $31.12 per share. Source
  • Repurchase timing depends on factors: Timing and amount of repurchases depend on capital needs, alternative investment opportunities, the share price and market conditions. Source

Clinical data at ASCO 2026

  • CABINET subgroup showed PFS benefit: A CABINET subgroup analysis presented at ASCO 2026 showed CABOMETYX improved PFS versus placebo in NET regardless of functional status. Source
  • Atezolizumab contribution in STELLAR-303: ASCO data support the contribution of atezolizumab to the survival benefit of zanzalintinib plus atezolizumab in metastatic colorectal cancer. Source
  • Anti-drug antibody work continues: The company said the anti-drug antibody data showed a need to study effects on exposure and checkpoint activity, and it plans to keep examining this across zanzalintinib programs. Source

Coming up, as management said on 5 August 2026

  • FDA decision on colorectal NDA: The PDUFA target action date is December 3, 2026. The potential launch is pending approval from regulatory authorities later this year. Source
  • STELLAR-316 start expected mid-2026: Initiation of the phase 3 STELLAR-316 trial is planned for mid-2026, with the company stating it remains on track. Source
  • STELLAR-304 topline in second half: Topline results from STELLAR-304 are expected in the second half of 2026, depending on event rates. Source
  • STELLAR-202 start in second half: Initiation of the phase 2 STELLAR-202 trial is expected in the second half of 2026. Source

Figures management reported

FigureReported
CABOMETYX net product revenues, Q2 2026 Source$570.6 million
Cabozantinib franchise U.S. net product revenues, Q2 2026 Source$573.0 million
Royalty revenues from partner cabozantinib sales, Q2 2026 Source$53.2 million
Research and development expenses, Q2 2026 Source$212.0 million
PDUFA target action date, zanzalintinib with atezolizumab in metastatic CRC SourceDecember 3, 2026
STELLAR-316 trial initiation timing Sourcemid-2026
STELLAR-303 NLM subgroup overall survival result Sourcenon-statistically significant trend favoring combination

Risks management discussed

  • Regulatory: Approval of the colorectal NDA remains subject to FDA review, and no launch revenue is included in guidance. Source
  • Operational: The NLM subgroup result showed a survival trend that was not statistically significant, after the intention-to-treat result was reported earlier. Source
  • Operational: The timing of the STELLAR-304 topline readout depends on event rates in the trial. Source

Earlier plans management reported on

  • On track: Management stated the company remains on track to start the STELLAR-316 trial in mid-2026. Source
  • Met: The final analysis of the NLM subgroup was announced in June 2026, the period the first quarter release had expected. Source
  • Met: The company said it completed the October 2025 program, fulfilling its $750 million commitment. Source
  • Met: Both the bladder cancer and mCRPC expansion cohorts have been initiated, with enrollment ongoing. Source
  • Not stated: The company restated its expectation to start STELLAR-202 in the second half of 2026. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.