EI
EXELIXIS, INC. (EXEL)·Q3 2026 Earnings Summary
Executive Summary
- Strong print with beats on revenue and non-GAAP EPS; Q3 delivered $597.8M revenue vs $590.2M consensus* and $0.78 non-GAAP diluted EPS vs $0.61 consensus*, driven by robust CABOMETYX U.S. demand and early NET launch contribution . Values retrieved from S&P Global.*
- Management narrowed FY25 revenue guidance to the upper end ($2.30–$2.35B) and cut R&D/ETR guidance, boosting full-year earnings power; also authorized an additional $750M buyback through 2026, reinforcing capital return momentum .
- Commercial execution remains a highlight: U.S. cabozantinib franchise net product revenue grew to $542.9M; gross-to-net ran ~30.4%; NET launch contributed ~6% of CABOMETYX demand and >40% new-patient share in 2L+ oral therapies, supporting 2026 growth trajectory .
- Pipeline catalysts in sight: STELLAR-303 (Zanza + atezo) showed a statistically significant OS benefit in 3L+ non‑MSI‑H CRC with NDA filing planned as soon as government reopens; final NLM analyses and STELLAR-304 nccRCC topline targeted around mid‑2026, positioning a second franchise opportunity .
- Potential stock reaction catalysts: near-term NDA filing for Zanzalintinib in CRC, continued NET launch ramp, guidance discipline, and sizable buyback authorization .
What Went Well and What Went Wrong
What Went Well
- CABOMETYX execution: U.S. cabozantinib net product revenue reached $542.9M; CABOMETYX maintained leadership in RCC and >40% new-patient share in 2L+ NET oral therapies; NET contributed ~6% of Q3 demand and is “vectoring towards exceeding $100M” in FY25 .
- Clear estimate beats: Revenue of $597.8M vs $590.2M consensus* and non‑GAAP diluted EPS of $0.78 vs $0.61 consensus*; operating income up to $236.5M (39.6% margin, calc.) . Values retrieved from S&P Global.*
- Management tone/confidence on Zanza: “The cabozantinib business has never been stronger, and we're pleased to see Zanzalintinib move to center stage with our first big clinical success in CRC.” – CEO Mike Morrissey . Plans to file NDA “as quickly as possible” for CRC and expand pivotal footprint (meningioma, adjuvant CRC) .
What Went Wrong
- Collaboration revenue down YoY: Q3 collaboration revenue declined to $54.8M vs $61.5M in 3Q24 on lower milestones and development reimbursements, partly offset by higher ex-U.S. royalties .
- Payer mix pressure: Gross-to-net for the CABO franchise was 30.4% (higher 340B discounts offset by lower Medicare/copay assistance), a watch item for pricing/mix into 2026 .
- Restructuring costs: Recognized $19.8M of restructuring (workforce reorg and facility closure), though largely completed in Q3 and tied to efficiency efforts; also carryover optics from prior-year facility impairment .
Financial Results
Note: Exelixis uses a 52/53-week fiscal year; Q3 reflects the period ended October 3, 2025 (referred to as September 30, 2025 for convenience) .
Consolidated financials (oldest → newest)
Actual vs S&P Global Consensus (Q3 2026)
Segment/Revenue mix
Selected KPIs (Q3 2026 unless noted)
Guidance Changes
Additional capital return: New $750M share repurchase authorization through end of 2026 .
Earnings Call Themes & Trends
Management Commentary
- “Exelixis had a strong third quarter… The Cabozantinib business has never been stronger, and we're pleased to see Zanzalintinib move to center stage with our first big clinical success in CRC.” – CEO Mike Morrissey .
- “US Cabo franchise net product revenues grew approximately 14% year-over-year to $543 million… Cabometyx maintained its leadership position as the top TKI for RCC.” – CEO Mike Morrissey .
- “We continue to carefully manage capital allocation… we have been authorized to repurchase an additional $750 million of our shares.” – CEO Mike Morrissey .
- “Gross-to-net for the Cabozantinib franchise in the third quarter 2025 was 30.4%… trade inventory… approximately two weeks on hand.” – CFO Chris Senner .
- “We intend to submit our first new drug application for zanzalintinib in the U.S. before year-end.” – Press release .
Q&A Highlights
- Zanza CRC positioning: Physicians value OS benefit and chemo‑free IO combo in non‑MSI‑H CRC; management expects share capture across a fragmented 3L+ market (~1/3 SUNLIGHT, ~1/3 TKIs, ~1/3 other) .
- Regulatory approach: Filing based on ITT OS primary endpoint provides broad label basis; NLM dual-primary to read mid‑2026; filing queued “ASAP” once government reopens .
- Capital allocation: Company expects to fund R&D (~$850–$900M), BD, and buybacks concurrently given revenue growth and prudent expense management .
- nccRCC and meningioma: STELLAR‑304 uses sunitinib as relevant SOC comparator; planning pivotal meningioma and adjuvant CRC starts in 2026 (dose exploration anticipated as moves earlier) .
- Commercial color: No clinical trial sales in quarter; NET launch uptake robust; expanding GI field footprint to deepen community reach ahead of potential Zanza launch .
Estimates Context
- Q3 results beat Street: Revenue $597.8M vs $590.2M consensus*; Primary EPS (non‑GAAP diluted) $0.78 vs $0.61 consensus*, with 16–17 covering estimates* . Values retrieved from S&P Global.*
- Given the magnitude of beat and updated FY25 guidance (higher revenue low end, lower R&D, lower tax rate), estimate revisions should move higher on EPS while revenue tweaks are modest toward the upper end of the range .
Key Takeaways for Investors
- Solid top-line and bottom-line beats, with operating margin expansion and disciplined guidance updates enhance near-term earnings quality .
- CABOMETYX remains the cash engine; NET launch traction (>40% 2L+ oral share) and GI sales expansion should sustain growth into 2026 .
- Zanzalintinib is the next leg: positive, differentiated OS result in non‑MSI‑H CRC with near-term NDA filing, plus a mid‑2026 cadence of additional pivotal data readouts (NLM OS, nccRCC) .
- Balance sheet strength and a new $750M buyback provide downside support and EPS accretion as diluted share count continues to trend lower .
- Watch items: payer mix (340B) in gross‑to‑net, collaboration revenue variability, and regulatory timing (government shutdown impacts submission timing) .
- Near-term trading setup: catalysts include NDA submission/acceptance for Zanza CRC, additional NET share gains, and potential year‑end/early‑year guidance commentary; buyback activity could underpin shares in volatile tape .
- Medium-term thesis: durable CABOMETYX + a potentially larger Zanza franchise across CRC and RCC can pivot EXEL to a multi‑franchise oncology company with improving mix and operating leverage .
Notes: Exelixis’ fiscal calendar uses a 52/53‑week year; Q3 reflects period ended October 3, 2025 (presented as September 30, 2025) .