Exelixis outlines March 3, 2027 PDUFA for zanza while advancing Wave 2 pivotal plans

• Michael Morrissey framed zanzalintinib as the next growth driver, saying, "zanzalintinib is positioned to drive the next phase of growth for Exelixis as our second franchise molecule," and emphasized continued expansion beyond current pivotal trials: "Beyond our current pivotal trials, we are actively advancing a second wave of potential pivotal trials that could further expand the scope, reach and long-term value of zanza in GU, GI and other indications."
• Morrissey tied CABOMETYX momentum to durability of the base business, stating, "CABO's strong third quarter performance reinforces our confidence in its long-term revenue growth trajectory," and highlighted Q3 2026 U.S. CABO franchise net product revenues of $605 million and global CABO franchise net product revenues (Exelixis and partners) of $818 million.
• Christopher Senner summarized the quarter’s financial performance, saying, "For the third quarter of 2026, the company reported total revenues of approximately $659 million," and added, "The company reported GAAP net income of approximately $218 million or $0.88 per share basic and $0.85 per share diluted," alongside non-GAAP net income of approximately $240 million or $0.97 per share basic and $0.94 per share diluted.
• Dana Aftab detailed zanza’s late-stage buildout and regulatory timeline, stating, "Regarding the NDA based on STELLAR-303, our updated PDUFA action date is March 3, 2027," and added on STELLAR-316 that "sites in this trial are now activated and enrolling participants." Aftab also announced a new candidate, saying, "we have a new development candidate in our pipeline, XL558... for which we plan to submit an IND later this year."

Outlook

• Management said it is "updating the full year 2026 financial guidance" (Executive VP & CFO Christopher Senner) and specified that the update reflects "changes to our cost of goods sold and our tax rate estimates," but no numeric ranges for revenue, EPS, expenses, or cash flow guidance were stated in the transcript.
• On key upcoming milestones, Aftab provided a specific zanza catalyst, saying, "we now expect top line results from the study to be available in the first quarter next year" for STELLAR-304.
• Compared with Q2 2026, the company previously described lowering and narrowing 2026 revenue guidance due to "a more gradual ramp for the NET indication" (Executive VP & CFO Christopher Senner). In Q3 2026, management did not describe a revenue guidance change in the prepared remarks, focusing instead on gross margin and tax-rate assumption updates.

Financial Results

• Senner reported total revenues of approximately $659 million in Q3 2026, including U.S. CABO franchise net product revenues of $605 million; CABOMETYX net product revenues were $603 million and "included no clinical trial sales."
• Profitability and expense levels were described as GAAP net income of approximately $218 million, with total operating expenses of approximately $390 million (vs. $380 million in Q2 2026) and provision for income taxes of approximately $64.7 million (vs. approximately $50.6 million in Q2 2026).
• On commercial economics and channel indicators, Senner said gross-to-net for the cabozantinib franchise was approximately 29% and attributed sequential improvement to "lower 340B discounts when compared to the second quarter," while updating the full-year 2026 gross-to-net projection to approximately 30%. He also said trade inventory ended at 1.8 weeks on hand.
• On capital allocation, Senner said cash and marketable securities were approximately $1.4 billion at quarter end and that Exelixis repurchased approximately $250 million of common stock (approximately 4.5 million shares at an average price per share of $55.77), leaving approximately $348 million under the $750 million plan authorized in May 2026.

Q&A

• Tsan-Yu Hsieh, William Blair: asked about 340B evolution and impact; CEO Michael Morrissey responded, "It has, to our knowledge, very little impact on us," and added, "we're seeing that stabilize in the business."
• Asthika Goonewardene, Leerink Partners: asked whether FDA interactions have reached labeling discussions for zanza; EVP R&D Dana Aftab replied, "I'm not going to speculate further on anything, especially regarding our interactions with the agency during an ongoing review."
• Manoj Eradath, Jefferies: asked about STELLAR-304 dropout/event rates and whether control-arm PFS assumptions changed; Aftab declined specifics, saying, "we're not going to get into details around enrollment or event rates" and pointed to timing: "we're now close to a clinical cutoff date."
• Sean Laaman, Morgan Stanley: asked how non-clear cell RCC could contribute versus CRC; EVP Commercial P. Haley said non-clear cell RCC is "about 20% of the renal cell carcinoma population" and called STELLAR-304 "the smallest" of Wave 1, while adding, "our vision and our goal is to make zanza the market leader in the 30s."
• Kalpit Patel, Wolfe Research: questioned why fiscal 2026 guidance was maintained despite momentum; CFO Senner linked back to Q2’s framework, saying the prior adjustment reflected "the temporal nature of the NET indication and the revenue growth associated with that."
• David Lebowitz, BMO: asked what drove the effective tax-rate guidance shift; Senner said timing after return filing allows release of reserves, adding, "our longer-term expectation is tax rate will be at the federal rate or thereabouts."
• Ashwani Verma, UBS: asked whether earlier-line CRC activity could change the stated 23,000-patient opportunity; Haley responded, "I think the patients are there as it is," and reiterated prescriber overlap and community strength.

Sentiment Analysis

• Analysts’ tone was slightly skeptical around FDA process, trial mechanics, and guidance (e.g., "Have you reached a labeling discussion stage" and questions on discontinuations and confounding), with repeated pressure on STELLAR-304 timing and interpretability.
• Management’s tone in prepared remarks was positive and expansion-focused (e.g., "zanza is in the spotlight" and "we remain laser-focused" from CEO Michael Morrissey), while in Q&A it was more guarded on regulatory and protocol specifics (e.g., "I'm not going to speculate" from EVP R&D Dana Aftab).
• Versus Q2 2026, management in Q3 used more definitive milestone language on timing (e.g., "first quarter next year" for STELLAR-304 and a specific "March 3, 2027" PDUFA), while analysts in Q3 concentrated more on execution details (dropouts, censoring, 340B) rather than Q2’s heavier emphasis on guidance reductions and CRC label risk.

Quarter-over-quarter comparison

• Q3 2026 emphasized CABO execution and zanza breadth with explicit new dates, including "March 3, 2027" for STELLAR-303 and a shift for STELLAR-304 to "the first quarter next year" (Executive Vice President of Research & Development Dana Aftab). In Q2 2026, STELLAR-304 timing was described as "the second half of 2026" (Aftab).
• Q2 2026 included a clear statement that guidance was being lowered and narrowed, with revenue guidance reflecting "modestly slower growth in 2026 due to a more gradual ramp for the NET indication" (Executive VP & CFO Christopher Senner). In Q3 2026, guidance commentary centered on updating cost of goods sold and tax-rate estimates without stating new revenue guidance figures in the transcript.
• Commercial metrics messaging tightened from Q2 to Q3: in Q2, P. Haley cited second-line plus NET new patient market share "greater than 45%," while in Q3 he said CABOMETYX second-line plus new patient oral market share "is now greater than 50%."

Risks and Concerns

• Management flagged variability in certain revenue components, with Senner cautioning, "clinical trial sales have historically been choppy between quarters."
• Several analyst questions focused on trial interpretability risk (dropouts, censoring, and control-arm dynamics). Management repeatedly declined to provide protocol-level specifics, with Aftab saying, "I don't want to get into details" and emphasizing proximity to cutoff: "we're close to data cutoff now."
• Commercial access and discounting risk surfaced via 340B and gross-to-net. Morrissey said 340B has "very little impact" and Senner attributed Q3 gross-to-net improvement to "lower 340B discounts" and updated the full-year gross-to-net projection to approximately 30%.

Final Takeaway

Management characterized Q3 2026 as a strong quarter driven by CABOMETYX performance and disciplined capital return, while positioning zanzalintinib as the next franchise catalyst with a now-specified March 3, 2027 PDUFA date and an anticipated STELLAR-304 topline readout in the first quarter next year; in Q&A, leadership stayed focused on milestones and strategy but consistently avoided speculating on FDA labeling discussions or granular trial mechanics.

Read the full Earnings Call Transcript

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