Exelixis, Inc. (EXEL) Earnings

Management highlights

ExoLexus had strong progress in 2026. Cabo Zantative business had strong performance with U.S. and global revenues growth. ZANSA's NDA for the ZANSA-ATEZA combination in third-line plus CRC is under review, with the development program rapidly advancing. The goal is to establish ZANSA as the TKI of choice. The development effort for ZANSA has multiple ongoing or soon-to-start pivotal trials. The team is committed to efficient business operation, with share repurchases and reiteration of full-year 2026 financial guidance. PJ discussed CaboMedics' growth and preparations for ZANSA launch. Dana reviewed ZANSA's development in various indications and early pipeline progress.

Guidance

Reiterating full year 2026 financial guidance detailed on slide 16 of the earnings presentation. The company expects to complete the October 2025 stock repurchase plan this month. In May 2026, a new $750 million stock repurchase plan was authorized that expires on December 31, 2027.

Segment performance

For the first quarter of 2026, total revenues were approximately $611 million. Cabo Zantative franchise net product revenues were $555 million, with CaboMedics net product revenues at $552.8 million including ~$3.6 million in clinical trial sales. Global Cabo franchise net product revenues grew 12.5% year-over-year to $764 million. U.S. Cabo franchise net product revenues grew 8% year-over-year to $555 million. Cash and marketable securities were approximately $1.4 billion as of March 31, 2026. CaboMedics continued to grow, being the number one prescribed TKI in renal cell carcinoma, etc., with Q1 having the highest number of new patient starts ever.

Risks & headwinds

Risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, dependence on collaboration partners, and level of costs associated with discovery, product development, business development, and commercialization activities.

Analyst Q&A

• Q: For Dana, in light of the recent miss from the LightSpark 012 study, comment on updated thoughts or learnings for Belzutivan plus Zanza combination development.

  A: Sure. Thanks for the question, Paul. Yeah, so first of all, you know, our strategy with ZANZA is to really focus on creating the next franchise molecule in RCC and the top TKI combination therapy in clear cell RCC in the 2030s. So, you know, the results from LightSpark 011 are, you know, that was with a, sorry, with 012, that was a triplet of PEM-LEN plus BELS versus PEM-LEN. As Mike mentioned earlier, triplet therapy in clear cell renal cell carcinoma is not an easy game, and, you know, our strategy is really focused on trying to establish a standard of care that covers multiple possible outcomes based on trials that are going on now. So we have multiple shots on goal with LightSpark 033, 034. We have the Stellar 304 data coming out hopefully soon, and non-clear cell and renal cell carcinoma. And as I mentioned earlier, we're evaluating a number of other potential novel and innovative combinations to further explore the Clear Cell RCC space. So that includes molecules from our own early pipeline. If XB628, which is our novel and innovative bispecific with multiple IO arms on it pans out, that could be a very interesting combination to explore in these patients. It would be very innovative and nothing in that space has been explored so far. So as Mike said earlier, we have multiple shots on goal to really establish and drive the Zanza franchise into Clear Cell RCC in the future, especially focused on the 2030s, not on today, but on the 2030s.

• Q: Hi, team. Congrats on the quarter, and thanks so much for the question. Just two quick questions from us. One, if you could please provide some color on the contribution in renal cell carcinoma versus NET for CABO. And then second, I recall that CABO failed as a monotherapy in advanced unselected non-small cell lung cancer and also on OS in phase 3 for pancreatic, even though it showed a response in PFS. So you touched on some of the combo regimens that have shown early data, but could you maybe expand on the rationale for testing combo therapies in stellar 202 and 002.

  A: Sure. So, you know, as I mentioned, the data that support our hypothesis for testing xantholinib in patients with non-small cell lung cancer comes from the CONTACT-01 study, which I think you're referring to. So this is the phase three study evaluating cabozantinib plus atezolizumab versus docetaxel in a broad population of non-small cell lung cancer patients. So in that study, the subpopulation of patients with squamous histology actually did quite well, appeared to have a favorable benefit compared to the control arm in the study. For that reason, the STELLAR-202 trial is focused 100% on the squamous patient population with non-small cell lung cancer. In this population, the current standard of care is platinum-based chemotherapy plus pembrolizumab during induction, which is up to four cycles of chemotherapy or 12 weeks. And then they go on pembrolizumab maintenance. So we are looking to add zanzalitinib onto the maintenance arm of pembrolizumab. We've already shown that ZANZA can sensitize patients to benefit with IO in the STELLAR-303 trial, a population of colorectal cancer patients that have historically been refractory to treatment with IO. So we think this is a very rational exploration to pursue for these patients with squamous histology, non-small cell lung cancer, and high unmet need. In prostate cancer, similarly, there was a small Phase I study combining cobizantinib with docetaxel. So the phase three trials that failed were not combining cobizantinib with chemotherapy. In the small phase one, however, we saw very, I'd say, favorable outcomes in the patients that were treated in this small study. So based on the results from that, we believe there is rationale to pursue that combination in the phase one stellar OO2 trial. Once we get data showing safety and potentially activity of that combination, that opens up a lot of different avenues of exploration, either in castration-resistant prostate cancer, potentially in lung cancer, and potentially in other indications where either chemo or chemo-based therapies, including ADCs, might be standard of care.