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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)

MetricQ1 2025Q2 2025Q3 2026 (quarter ended Sep 30, 2025)
Revenue ($M)$555.4 $568.3 $597.8
GAAP Diluted EPS$0.55 $0.65 $0.69
Non-GAAP Diluted EPS$0.62 $0.75 $0.78
Income from Operations ($M)$186.9 $213.6 $236.5
Operating Margin % (calc.)33.7% (from cited figures) 37.6% (from cited figures) 39.6% (from cited figures)
Net Income ($M)$159.6 $184.8 $193.6
Net Income Margin % (calc.)28.7% (from cited figures) 32.5% (from cited figures) 32.4% (from cited figures)

Actual vs S&P Global Consensus (Q3 2026)

MetricActualConsensus*Surprise
Revenue ($M)$597.8 $590.2*+$7.6
Primary EPS (Non-GAAP diluted)$0.78 $0.61*+$0.17
Values retrieved from S&P Global.*

Segment/Revenue mix

Revenue MixQ1 2025Q2 2025Q3 2026
Net Product Revenues ($M)$513.3 $520.0 $542.9
– CABOMETYX ($M)$510.9 $517.9 $539.9
– COMETRIQ ($M)$2.4 $2.1 $3.1
Collaboration Revenues ($M)$42.2 $48.2 $54.8
Total Revenues ($M)$555.4 $568.3 $597.8

Selected KPIs (Q3 2026 unless noted)

KPIQ1 2025Q2 2025Q3 2026
Gross-to-net (CABO franchise)30.4%
Trade inventory (weeks)~2 weeks
Royalty Revenues ($M)$36.7 $43.4 $46.3
Cash & Marketable Securities ($B)~$1.6
Share Repurchases in Quarter ($M)~$99 (2.4M shrs at $41.69)
Weighted-avg Diluted Shares (M)288.2 284.4 278.5

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenuesFY 2025$2.25B – $2.35B (prev. provided May 13, 2025)$2.30B – $2.35B Narrowed to upper end (raised low end)
Net Product RevenuesFY 2025$2.05B – $2.15B (incl. 2.8% WAC increase) $2.10B – $2.15B Raised low end
Cost of Goods SoldFY 20254% – 5% of net product rev. ~4% of net product rev. Tightened lower
R&D ExpenseFY 2025$925M – $975M (incl. $50M SBC) $850M – $900M (incl. $40M SBC) Lowered
SG&A ExpenseFY 2025$475M – $525M (incl. $80M SBC) $500M – $525M (incl. $80M SBC) Tightened higher floor
Effective Tax RateFY 202521% – 23% 17% – 18% Lowered

Additional capital return: New $750M share repurchase authorization through end of 2026 .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2026)Trend
CABOMETYX demand and RCC leadershipStrong demand; FY25 guidance raised; early NET launch U.S. net product rev $520M; EU NET approval via Ipsen U.S. net product rev $542.9M; RCC leadership maintained; NET >40% 2L+ oral share; ~6% demand contribution Improving
NET launchFDA approval late March; rapid mobilization NET ~4% of CABO business; leadership in new patient starts >40% new-patient share; >50% QoQ demand growth; FY25 NET rev to exceed $100M Accelerating
Zanzalintinib (CRC)Anticipated STELLAR‑303 readout; plan to file quickly Topline positive OS (ITT); plan to file ASAP Detailed ESMO/Lancet data; OS HR 0.80; NDA planned ASAP pending govt reopening Advancing
Zanzalintinib (nccRCC)STELLAR‑304 enrollment completed; H1’26 topline dependent on events SameTopline now mid‑2026 timing; still targeted Slightly delayed on events
GI commercial build-outPreparing for broader GI opportunity Expediting GI sales team build in Q4 to prime NET and future Zanza CRC launch Scaling up
Capital returnsRepurchases ongoing; shares down to 288.2M diluted Repurchased $796.3M cumulatively; diluted shares 284.4M Additional $750M authorization; diluted shares 278.5M Increasing
Tax law benefit$147M federal cash tax benefit from R&E repeal (no P&L provision impact) Positive cash impact

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) .