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EXEL

EXELIXIS, INC.

EXELIXIS, INC. Q2 FY2025 earnings call

July 28, 2025 · fiscal period ended 2024-07

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Summary

Generated 2025-07-28

Management highlights

Mike Morrissey mentioned Exelixis had a strong Q2 2025. Cabozantinib U.S. business grew strongly. Zanzalintinib's STELLAR-303 had positive topline in CRC, STELLAR-304 in non-clear cell RCC is fully enrolled, STELLAR-305 not advanced. Early-stage pipeline progressing with XL309, XB010, XB628, XB371. Focus on capital allocation and business development

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Segment performance

Cabozantinib U.S. business had net product revenues of $520 million in Q2 2025, up 19% YOY, contributing ~4% to Q2 net product revenue. Zanzalintinib's STELLAR-303 showed positive topline in CRC, STELLAR-304 in non-clear cell RCC is fully enrolled, STELLAR-305 not advanced due to competition. Early-stage pipeline advancing with XL309, XB010, XB628, XB371

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Guidance

Continue to evaluate further updates to 2025 financial guidance. Reiterate full year 2025 financial guidance as detailed in earnings presentation

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Risks

Risks related to product commercial success, market competition, regulatory review and approval, clinical trials, compliance, dependence on collaboration partners, and costs associated with R&D, business development, etc

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Q&A highlights

Q: David Lebowitz asks about takeaways from head and neck, A: Amy says rigorous drug development requires continuous assessment.

Q: Sean Laaman asks about market share endurance and NET market share, A: Mike and P.J. say confident in growth in both.

Q: Michael Schmidt asks about STELLAR-303 and NLM, A: Amy says positive OS in ITT, will share data later.

Q: Asthika Goonewardene asks about clinical meaningfulness and advancing earlier lines, A: Amy says OS was statistically significant, interested in adjuvant CRC.

Q: Silvan Tuerkcan asks about pricing dynamics, A: Chris says 340B volume impact on gross to net, projecting ~30% gross to net.

Q: Yaron Werber asks about STELLAR-304 endpoints and control arm, A: Amy says dual primary endpoints, will share data later.

Q: Akash Tewari asks about head and neck no-go decision, A: Amy says dynamic landscape, prioritizing other indications.

Q: Jason Gerberry asks about STELLAR-303 enrollment and adjuvant CRC sizing, A: Amy says global enrollment, will share post-adjuvant study details later.

Q: Anish Nikhanj asks about balancing zanza's potential, A: Mike says prioritizing high PTS and commercial potential opportunities.

Q: Tsan-Yu Hsieh asks about CRC epidemiology and treatment duration, A: Amy says duration and population important, Mike says will share post-adjuvant study details.

Q: Andrew Berens asks about STELLAR-303 FDA contribution and NLM benefit, A: Amy says contribution from separate study, positive OS in ITT, will share NLM data later.

Q: Derek Archila asks about NET revenue trajectory and prescribing breadth, A: Mike says no quarter-to-quarter guidance, P.J. says broad prescriber base.

Q: Sudan Loganathan asks about STELLAR-303 dual endpoint and guidance inclusion, A: Amy says dual endpoint can be positive on one, Chris says guidance includes some NET contribution.

Q: Peter Lawson asks about clinical trial revenues in H2, A: Chris says clinical trial sales are choppy, hard to predict.

Q: Stephen Willey asks about 305 decision cadence, A: Amy says trial designed with gate, reviewed data, prioritizing other indications.

Q: Ash Verma asks about STELLAR-303 data presentation, A: Amy says will provide data when abstract titles available

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Transcript

July 28, 2025

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