Exelixis: The Zanza Clock Slips, the Franchise Clock Keeps Ticking

A strong CABOMETYX quarter and a broader Wave 2 plan cannot fully mask a PDUFA push to March 2027 and STELLAR-304’s slide into Q1.

EXEL · Earnings Call · 2026-10-29

A strong quarter, a slipped clock

zanzalintinib is positioned to drive the next phase of growth for Exelixis as our second franchise molecule, potentially first with the third line plus CRC opportunity, followed by several waves of pivotal trials that we’ll highlight today.
Michael M. Morrissey, President and Chief Executive Officer · 2026-10-29

Exelixis’s Q3 was operationally clean: total revenue of about $659 million, U.S. CABOMETYX net product revenue of $605 million, global franchise revenue of $818 million, GAAP net income of $218 million and roughly $1.4 billion of cash. The CABOMETYX franchise grew 12% year over year, with TRx up 13% and share in the oral TKI basket rising to 49% from 46%. But the quarter’s real news was not the P&L; it was the calendar. The zanzalintinib NDA based on STELLAR-303 now has a PDUFA date of March 3, 2027. “Regarding the NDA based on STELLAR-303, our updated PDUFA action date is March 3rd, 2027.” — Dana T. Aftab, Executive Vice President · 2026-10-29 In May, management had described the review as “progressing on schedule toward the PDUFA date in early December.” “progressing on schedule toward the PDUFA date in early December.” — Dana T. Aftab, Executive Vice President · 2026-05-05 That is a real push, not a rounding error. The same pattern appears in STELLAR-304, the non-clear-cell RCC trial. Management now expects top-line data in Q1 2027; in August it was still guiding to events in the second half of 2026. “we are expecting to achieve the planned number of events in the second half of this year.” — Dana Aftab, Executive Vice President of Research and Development · 2026-08-05 In the current call, Dana Aftab would only say that “based on the events coming in, we are now close to a clinical cutoff date.” “based on the events coming in, we are now close to a clinical cutoff date, and that is driving our expectations around Q1 for the top-line results.” — Dana T. Aftab, Executive Vice President · 2026-10-29 Investors are left to infer whether the delay reflects event accrual, enrollment mix, or regulatory back-and-forth. Management declined to elaborate on FDA interactions or label discussions.

The commercial engine is humming — so why no raise?

The community setting remains Exelixis’s moat. PJ Haley said the expanded GI sales team has now been in the field for a second full quarter, with more than 1,000 unique NET prescribers activated and new-patient oral share above 50% in second-line-plus NET. The company also called out contemporary pricing for the third-line-plus CRC opportunity: roughly 23,000 U.S. patients and a $1.5 billion market. The prescriber overlap with CABOMETYX is about 70%, rising to 90% including co-located addresses. That is a launch handoff most biotechs would envy. Yet revenue guidance was maintained, not raised. CFO Chris Senner was explicit: “the business continues to be strong. But... when we adjusted our revenue guidance down, it was because of the temporal nature of the NET indication... That continues today.” — Christopher J. Senner, Executive Vice President and Chief Financial Officer · 2026-10-29 This is a recurring refrain. On the prior call, PJ described the NET ramp as “a little more gradual” because of patient kinetics in a more indolent tumor. “it's just kind of the ramp is a little more gradual” — P. Haley, Unspecified Executive (likely Commercial or Strategy) · 2026-08-05 The good news is that gross-to-net came in at 29% for Q3, below Q2, helped by lower 340B discounts; management now sees full-year gross-to-net around 30%. But the decision not to lift the top line despite an 11% increase in the U.S. CABOMETYX franchise suggests either conservatism or a genuine worry that NET refills will not inflect as quickly as the bull case assumes. The balance sheet gives them room. Effective net cash was about $1.0 billion, up 33% year over year. Total revenue was $629 million in the June quarter, up 11% year over year, before the $659 million Q3 print. The company repurchased $250 million of stock in Q3 at an average of $55.77 and has $348 million left on its $750 million authorization. Repurchases totaled $323 million in the June quarter and $250 million in Q3. That supports the stock, but it is not a substitute for catalysts.

Wave 2 is the real option value

The bull case is no longer just CABOMETYX. Exelixis is trying to turn zanzalintinib into a multi-indication franchise, with seven label-enabling Wave 1 trials already running and a broadening Wave 2. The new disclosures: STELLAR-202 in squamous NSCLC is now enrolling; a bladder cancer cohort post enfortumab vedotin plus PD-1 has enrolled “extremely quickly”; XB628 plus zanza is in the clinic; and a docetaxel combination in metastatic CRPC is underway. Bladder cancer is a particularly interesting white space because, as PJ put it, it is “kind of a new data-free zone” after EV/pembro. The strategy is to make zanza the TKI backbone for immune checkpoint inhibitor combinations across GU and GI. That is a credible ambition, and it is why the PDUFA slip has not broken the stock. There is also a new pipeline candidate: XL558, an oral somatostatin receptor 2 agonist, with an IND planned later this year. It fits the NET franchise build-out beyond CABOMETYX and zanza. The company is clearly trying to seed the next leg of growth before the current one is de-risked.

What to watch

The setup is a company with a cash-generative commercial base, a near-high stock, and two key catalysts pushed into 2027. The stock trades at about 15.9x trailing net income. That is not demanding for a biotech with $1 billion-plus net cash and a buyback. But the recent 90-day tape shows a 25% rally, so the market has already voted for the franchise story. The risk is that another slip in the March PDUFA or the Q1 STELLAR-304 readout turns a “show-me” story into a “why-now” story. The opportunity is that Wave 2 and the CABOMETYX base are enough to keep the earnings stream growing while the market waits.