Oct 29, 2026 earnings call — Zanzalintinib takes center stage
Exelixis said U.S. CABO franchise net product revenues grew approximately 11% year-over-year to $605 million.
Revenue $0.7B (est $0.6B) · EPS $0.94 (est $0.89)
Key quotes
"Zanza remains our #1 R&D priority, and we are advancing key objectives across the program."
"CABO remains the leading TKI for RCC and the market leader for the oral second-line plus NET segment."
"Third, our commitment to rigorous expense management and capital allocation is unwavering as we invest in our mission-critical R&D priorities while returning cash to shareholders with our share repurchase program."
Analyst Q&A 15
340B program impact
Q (Tsan-Yu Hsieh · William Blair): Analyst asked how changes in the 340B program could affect the existing CABO franchise and the zanza program.
A: Management said the 340B developments have very little impact on their business. They have an integrity agreement and an engaged market access team, and they see the situation stabilizing.
"It has, to our knowledge, very little impact on us." — Michael Morrissey (CEO)
FDA labeling discussions
Q (Asthika Goonewardene · Leerink Partners): Analyst asked whether zanza is at the labeling discussion stage with the FDA.
A: Management reiterated the PDUFA date is now in March next year. They declined to speculate about ongoing agency interactions during the review.
"Beyond what I said in the prepared remarks around our PDUFA date now being in March next year." — Dana Aftab
STELLAR-304 event rates
Q (Manoj Eradath · Jefferies): Analyst asked whether arm-specific adverse-event dropout rates in STELLAR-304 match assumptions and whether the control arm median PFS remains unchanged.
A: Management said they are excited about the 304 study as the first global randomized Phase III in this setting. They would not discuss enrollment or event-rate details but said events are coming in and they are close to a clinical cutoff driving a Q1 topline result expectation.
"So first of all, we're really excited about the 304 study." — Dana Aftab
Non-clear cell RCC size
Q (Sean Laaman · Morgan Stanley): Analyst asked how large non-clear cell RCC could be within the zanza franchise compared with CRC.
A: Management said the non-clear cell population is about 20% of renal cell carcinoma and noted 304 is the smallest Wave 1 study. They see kidney cancer as an important area and are exploring multiple combinations and trials to grow the program.
"This population is about 20% of the renal cell carcinoma population." — P. Haley
LITESPARK studies and belzutifan
Q (Michael Schmidt · Guggenheim): Analyst asked about the size and potential of LITESPARK-034 and -033 and how adjuvant belzutifan approval might affect the patient population.
A: Management said LITESPARK-033 is in the frontline post-adjuvant setting and the impact will depend on how adjuvant data evolve. They described LITESPARK-034 as adding zanza to belzutifan, which could be differentiated and potentially impactful in second-line-plus kidney cancer.
"And then certainly, we're excited about LITESPARK-034, where we're -- the design of that is adding zanza to belzutifan." — P. Haley
ESMO takeaways for CABO and zanza
Q (Silvan Tuerkcan · Citizens): Analyst asked what ESMO 2026 taught them for CABO, learnings from failed LITESPARK studies, bispecifics, and zanza in colorectal.
A: Management said ESMO was busy and generated lots of engagement. They saw little new data that changes CABO today, and they view newer IO mechanisms as orthogonal to zanza, supporting zanza as a backbone for future combinations.
"Overall, from the data presented, I think there wasn't really a lot new there in terms of impacting CABO today." — P. Haley
OS censoring in STELLAR-304
Q (Jason Gerberry · BofA): Analyst asked whether patients who discontinue (for example to get a PD-1 TKI) would be censored or otherwise affect OS analysis in STELLAR-304.
A: Management declined to discuss trial specifics or speculate about dropout effects. They reiterated excitement about delivering Level 1 evidence and that they are close to data cutoff, which drives their Q1 topline timing.
"Regarding the specifics of the trial, I don't want to get into details there, and I don't want to speculate on the potential for dropout or anything else like that." — Dana Aftab
NET patient accumulation and guidance
Q (Truist): Analyst asked how starts and time on therapy in NET are translating into patient accumulation versus last quarter and what the maintained revenue guide assumes for Q4.
A: Management said NET demand continues to grow and their new patient market share in the second-line-plus oral setting is now over 50%. They see continued refills and expect ongoing strength given the indolent nature of NET and strong duration of therapy.
"And as you referred to now our new patient market share in that second-line plus oral setting is now over 50%, which is great." — P. Haley
STELLAR-316 arm signals
Q (Leonid Timashev · RBC): Analyst asked how to interpret the relative signals between pembro alone and zanza+pembro arms in STELLAR-316 and how physicians might choose if both succeed.
A: Management said the cohort design addresses component contribution in microsatellite-stable CRC. They do not expect pembro alone to be active, single-agent zanza could show activity, and the pembro plus zanza cohort is expected to perform best, with final decisions depending on the data.
"And then pembro plus zanza, we expect to perform the best, obviously." — Dana Aftab
Maintaining fiscal guidance
Q (Kalpit Patel · Wolfe): Analyst asked why EXEL maintained fiscal year '26 guidance despite CABO growth and whether guidance includes any impact from LITESPARK-011.
A: Management said the business is doing well and the pipeline is growing. They reiterated that their prior guidance reduction reflected the temporal nature of NET revenue growth, which continues to be a factor.
"As we talked about last quarter, when we adjusted our revenue guidance down, it was because of the temporal nature of the NET indication and the revenue growth associated with that." — Christopher Senner (CFO)
Metastatic vs adjuvant CRC role
Q (Etzer Darout · Barclays): Analyst asked about the longer-term relative contribution of zanzalintinib in adjuvant CRC versus metastatic CRC.
A: Management said the metastatic third-line-plus setting has significant unmet need and could bring immunotherapy to a broader CRC population (they cited 23,000 patients and about a $1.5 billion TAM). For the post-adjuvant STELLAR-316 population, they said ctDNA-positive patients recur quickly (about 6 to 8 months) and adjuvant benefit could be highly meaningful.
"Now in terms of that post-adjuvant population, the STELLAR-316 population, it's a very exciting study, as Dana referred to it, area of significant unmet medical need." — P. Haley
Q4 tax rate change
Q (David Lebowitz · BMO): Analyst asked what caused the shift in the effective tax rate in Q4 and how to view tax rate going forward after Q4.
A: Management explained that after filing tax returns in October they were able to recognize items reserved in prior periods, which they did this year and last. They are not giving long-term guidance but expect the tax rate to be at the federal rate or thereabouts over the longer term.
"I would say that we're not giving guidance longer term, but our longer-term expectation is tax rate will be at the federal rate or thereabouts." — Christopher Senner (CFO)
Early-line CRC competition and reach
Q (Ashwani Verma · UBS): Analyst asked whether earlier-line CRC programs could change the 23,000 addressable patient population for zanza.
A: Management said the patient population remains sizable and physicians are excited about the potential regimen. They highlighted their CABOMETYX commercial capabilities and noted prescriber overlap with CRC targets—about 70%, rising to 90% including the same addresses.
"We have prescriber overlap estimated with our CRC targets with regards to CABOMETYX of about 70%, and it goes to 90% if you include the same addresses." — P. Haley
ARC-20 data and zanza dose
Q (Yaron Werber · TD Cowen): Analyst asked what the ARC-20 cas/cabo data imply for CABO and whether zanza doses in upcoming Wave 1 studies include 60 mg starts.
A: Management said a positive study that includes CABO could provide incremental opportunity for CABO. On dose, they said dose selection requires extensive exposure-response modeling and depends on the indication, combination partner, and line of therapy, so they cannot specify doses now.
"So we -- a lot of work goes into selecting dose for a trial based on extensive modeling from the perspective of exposure response, looking at either tumor response or safety." — Dana Aftab
Bladder cohort and oral SSTR2
Q (Tsan-Yu Hsieh · William Blair): Analyst asked about the standard of care and efficacy bar for STELLAR-002 bladder cohort post-PADCEV and pembro, and about the TPP for oral SSTR2 (XL-558) versus injectables.
A: Management said EV/pem has strong data and is widely used, and the bladder cohort is enrolling quickly in a field with limited options. They noted EV/IO is moving earlier and validated the unmet need. They did not provide specific comparative TPP details for the oral SSTR2 versus injectables in this exchange.
"I think, obviously EV/pem, great data there has done very well for patients with metastatic bladder cancer." — P. Haley