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EXELIXIS, INC. (EXEL)·Q1 2026 Earnings Summary

Executive Summary

  • Primary source documents for Q1 2026 (8-K 2.02 press release and earnings call transcript) were not available in our document catalogs; we anchored this recap on S&P Global consensus for Q1 2026 and verified trends from Q2–Q3 2025 filings/calls.
  • Consensus for Q1 2026 stands at $624.23M* revenue and $0.73* EPS (6 EPS estimates; 4 revenue estimates). Values retrieved from S&P Global.
  • Q3 2025 delivered strong execution: total revenue $597.8M, GAAP EPS $0.69, non-GAAP EPS $0.78; U.S. cabozantinib net product revenue $542.9M; guidance tightened to the upper end for FY25 and new $750M buyback authorized.
  • Strategic catalysts into early 2026: filing NDA for zanzalintinib + atezolizumab in late-line CRC as soon as the government reopens; continued NET uptake for CABOMETYX; GI sales build-out to support CRC launch.

What Went Well and What Went Wrong

What Went Well

  • Cabozantinib franchise momentum: Q3 2025 U.S. net product revenues reached $542.9M; cabozantinib maintained #1 TKI share in RCC with TRx share rising from 42% to 46% YoY and NET demand contributing ~6% of total demand.
  • Zanzalintinib pivotal success: STELLAR-303 in non‑MSI‑H CRC met the ITT OS endpoint (HR 0.80; p=0.0045); company intends to file NDA promptly on government reopening.
  • Management tone on execution: “Accelerating R&D momentum, coupled with flawless commercial execution, has the potential to transform our business…”

What Went Wrong

  • Collaboration revenues softness in Q3 2025 vs. prior year due to lower milestone recognition and development reimbursements (partially offset by higher ex‑U.S. royalties).
  • Restructuring charges: $19.8M in Q3 2025 lifted operating expenses sequentially (Q3 opex $361M vs. $355M in Q2).
  • Gross‑to‑net headwinds: higher 340B discounts impacted Q3 deductions, though partially offset by lower Medicare/copay assistance; gross‑to‑net projected ~30% for the year.

Financial Results

MetricQ1 2025Q2 2025Q3 2025Q1 2026E
Revenue ($USD Millions)$555.4 $568.3 $597.8 $624.23*
GAAP Diluted EPS ($)$0.55 $0.65 $0.69 $0.73*
Non‑GAAP Diluted EPS ($)$0.62 $0.75 $0.78 n/a

Note: Values retrieved from S&P Global for Q1 2026 estimates (marked with *).

Segment/MetricQ1 2025Q2 2025Q3 2025
U.S. Cabozantinib Net Product Revenues ($M)$513.3 $520.0 $542.9
Royalty Revenues ($M)$36.7 $43.4 $46.3
Gross‑to‑Net (Cabozantinib) (%)n/a30.2 30.4
Trade Inventory (weeks on hand)n/an/a~2

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenues ($)FY 2025$2.15B–$2.25B $2.30B–$2.35B Raised/Narrowed
Net Product Revenues ($)FY 2025$1.95B–$2.05B $2.10B–$2.15B Raised/Narrowed
Cost of Goods (% of NPR)FY 20254%–5% ~4% Tightened/Lowered
R&D Expenses ($)FY 2025$925M–$975M $850M–$900M Lowered
SG&A Expenses ($)FY 2025$475M–$525M $500M–$525M Tightened
Effective Tax Rate (%)FY 202521%–23% 17%–18% Lowered
Share Repurchase Authorization ($)Through 2026$1.0B programs through 2025 +$750M new authorization to end‑2026

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2025)Previous Mentions (Q3 2025)Current Period (Q1 2026)Trend
Zanzalintinib (CRC)Positive topline STELLAR‑303; intent to file quickly ITT OS benefit; NDA filing planned as soon as government reopens n/aStrengthening catalyst
CABOMETYX NET LaunchEarly strong reception; NET share gains >40% new patient share in oral 2L+ NET; demand +50% QoQ n/aAccelerating adoption
RCC LeadershipCheckMate‑9ER longer‑term data supports 1L combo; share gains Highest ever 1L cabo+nivo market share; TRx growth outpacing market n/aDurable leadership
Capital AllocationOngoing buybacks; strong cash balance (~$1.4B) $99M repurchased in Q3; new $750M authorization n/aContinued return of capital
R&D ExecutionSTELLAR‑304 fully enrolled; multiple early programs advancing Seven pivotal Zanza trials; INDs and Phase 1s in early pipeline n/aBroadening pipeline

Management Commentary

  • “US Cabo franchise net product revenues grew approximately 14% year‑over‑year to $543 million…we’re expediting the full build‑out of our GI sales team…before Zanza comes to the forefront.”
  • “For the third quarter 2025…Cabometyx net product revenues were approximately $540 million…gross‑to‑net…30.4%…we are narrowing our total revenue and net product revenue guidance to the upper end…”
  • “The study met one of its dual primary endpoints…HR 0.80…median OS 10.9 months with Zanza + Atezo vs 9.4 months with Rego…we intend to submit [the NDA] this December pending the government reopening…”

Q&A Highlights

  • CRC market dynamics: fragmented third‑line market (~⅓ SUNLIGHT regimen, ~⅓ TKIs, ~⅓ other chemos/targeted); expectation to take share across competitors; GI team build‑out to reach community prescribers.
  • STELLAR‑303 endpoints: ITT OS hit supports broad label filing; NLM OS endpoint final analysis expected ~mid‑2026.
  • Merck collaboration: confirmation trials to proceed; no Q3 clinical trial sales for cabozantinib.
  • Capital allocation: company intends to fund R&D, BD, and share repurchases concurrently given revenue growth and expense discipline.

Estimates Context

  • Q1 2026 consensus: Revenue $624.23M*, EPS $0.73* (6 EPS estimates; 4 revenue estimates). Values retrieved from S&P Global.
  • With FY25 guidance raised/narrowed at Q3 and strong NET uptake, Street may revise FY26 trajectory upward for cabozantinib and factor CRC contributions upon zanzalintinib approval timing.

Key Takeaways for Investors

  • Execution remains strong: Q3 2025 beat on non‑GAAP EPS ($0.78 vs $0.68 consensus) and revenue ($597.8M vs $590.0M), signaling resilient demand and disciplined opex.
  • CRC NDA filing for zanzalintinib + atezolizumab is a near‑term binary catalyst as soon as government operations resume; STELLAR‑303 demonstrated the first OS benefit in non‑MSI‑H CRC vs SOC.
  • NET launch momentum is building (>40% new patient share; demand +50% QoQ), with GI sales expansion to support both CABOMETYX NET and future CRC opportunities.
  • Capital returns continue: new $750M buyback authorization through 2026 alongside robust cash and marketable securities ($1.6B at Q3).
  • Guidance raised to upper end for FY25 on revenue and NPR, with lower R&D/tax rate—supporting EPS leverage into 2026 barring unforeseen headwinds.
  • Watch gross‑to‑net dynamics (30% range) and collaboration revenue variability; these can affect quarterly optics despite underlying demand strength.
  • Near‑term trading: position for CRC filing headlines and any label/launch updates; medium‑term thesis anchored on multi‑franchise evolution (cabozantinib + zanzalintinib) and durable RCC/NET leadership.

Notes on sourcing: Q1 2026 primary source documents (press release and call transcript) were not available in our catalogs at time of research; Q1 2026 comparisons rely on S&P Global consensus for estimates (marked with *; Values retrieved from S&P Global). Trend analysis references Q2–Q3 2025 press releases and the full Q3 2025 earnings call transcript.