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EXELIXIS, INC. (EXEL)·Q4 2025 Earnings Summary

Executive Summary

  • Q4 2025 results and 8‑K 2.02 filing are not yet available; this recap synthesizes the most recent primary sources (Q3 2025 call and materials, Q2 2025 press release) and FY25 guidance to frame the setup into Q4 .
  • Q3 2025 was solid: total revenues ≈$598M, Cabozantinib franchise net product revenues ≈$543M, gross‑to‑net 30.4%, collaboration revenues ≈$54.8M (royalties ≈$46.3M); non‑GAAP diluted EPS $0.78; cash and marketable securities ≈$1.6B .
  • NET launch continues to outperform: >40% new‑patient share in 2L+ oral segment; NET demand +50% q/q; management expects >$100M 2025 revenue from NET .
  • Zanzalintinib (Zanza) momentum: STELLAR‑303 achieved statistically significant OS benefit in non‑MSI‑H CRC (median OS 10.9 months ITT); NDA filing planned “ASAP” when government reopens; commercial GI build‑out underway to prepare for CRC and accelerate Cabo NET growth .
  • Capital allocation supportive: $99M buybacks in Q3; new $750M program authorized through 2026; FY25 guidance narrowed upward (TR and net product), R&D cut by ~$75M, tax rate lowered to 17–18% heading into Q4 .

What Went Well and What Went Wrong

  • What Went Well

    • Cabozantinib execution: US Cabo franchise net product revenue grew ≈14% YoY to ≈$543M; Cabo remained #1 TKI in RCC with record 1L share .
    • NET launch outperformance: >40% NET 2L+ oral new‑patient share; +50% demand q/q; trajectory “vectoring towards exceeding $100M” 2025 revenue .
    • Guidance/returns: TR and net product ranges tightened to the upper end; R&D and tax rate lowered; incremental $750M repurchase authorization .
    • Management quote: “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.” .

  • What Went Wrong

    • Gross‑to‑net headwind: gross‑to‑net 30.4% in Q3 with higher 340B discounts; management still projects ~30% for the year .
    • Opex uptick from restructuring: Q3 opex ≈$361M included a $19.8M restructuring charge (partially offset by lower SG&A) .
    • Pipeline pruning/uncertainties: head & neck (STELLAR‑305) discontinued earlier in 2025; STELLAR‑303 NLM endpoint awaits final analysis (target mid‑2026), leaving some investors focused on “contribution of components” risk until full data mature .

Financial Results

Recent quarters (oldest → newest). Q4 2025 not yet reported.

Metric (USD unless noted)Q2 2025Q3 2025
Total Revenues ($M)$568.3 ≈$598.0
Net Product Revenues ($M)$520.0 ≈$543.0
Collaboration Revenues ($M)$48.2 ≈$54.8
Royalties within Collaboration ($M)$43.4 ≈$46.3
GAAP Diluted EPS ($)$0.65 $0.69
Non‑GAAP Diluted EPS ($)$0.75 $0.78
Gross‑to‑Net (%)30.2% 30.4%
Total Operating Expenses ($M)$355 ≈$361
Provision for Income Taxes ($M)$45.6 ≈$58.8
Cash & Marketable Securities ($B)≈$1.4 ≈$1.6
Share Repurchase ($M)$302 (7.5M sh @ $40.10) $99 (2.4M sh @ $41.69)

Revenue mix

Revenue Mix ($M)Q2 2025Q3 2025
Cabozantinib Franchise Net Product$520.0 ≈$543.0
Collaboration (incl. Royalties)$48.2 ≈$54.8
of which: Royalties$43.4 ≈$46.3

Commercial and operating KPIs

KPIQ2 2025Q3 2025
Trade Inventory (weeks on hand)~2.2 weeks ~2.0 weeks
Gross‑to‑Net (Cabo)30.2% 30.4%
RCC TRx Share YoY Δ (pp)+4pp (41%→45%) +4pp (42%→46%)
NET 2L+ Oral New‑Patient Share~35% >40%
NET Demand as % of Cabo Demandjust >4% ~6%
NET Demand Growth (q/q)—>+50%

Notes: Q4 2025 estimates unavailable from S&P Global due to access limits at this time; management does not provide quarterly guidance, but FY25 guidance was tightened in Q3 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenuesFY 2025$2.25B–$2.35B $2.30B–$2.35B Tightened up to upper end
Net Product RevenuesFY 2025$2.05B–$2.15B $2.10B–$2.15B Tightened up to upper end
Cost of GoodsFY 20254–5% of net product ≈4% Lowered/tightened
R&D ExpenseFY 2025$925M–$975M $850M–$900M Lowered (~$75M)
SG&A ExpenseFY 2025$475M–$525M $500M–$525M Narrowed (raised floor)
Effective Tax RateFY 202521%–23% 17%–18% Lowered

Earnings Call Themes & Trends

TopicQ2 2025 (Q‑2)Q3 2025 (Q‑1)Current Period (Q4 2025)
Zanzalintinib CRC (STELLAR‑303)Positive topline OS benefit in ITT; planning regulatory engagement Median OS 10.9m (ITT); NDA filing “ASAP” pending gov’t reopening; fragmented CRC market (~⅓ each SUNLIGHT, TKIs, other) Pre‑release: filing plan and GI build‑out remain priorities into Q4
NET Launch (Cabo)~35% 2L+ oral new‑patient share; best‑in‑class perception; >4% demand >40% share; +50% q/q demand; targeting >$100M 2025 NET revenue Accelerate via GI sales expansion initiated in Q4 to drive NET momentum
RCC Franchise#1 TKI; TRx share +4pp YoY (41→45) #1 TKI + IO in 1L; highest 1L share ever; TRx up 21% YoY Continued focus on 1L RCC positioning heading into 2026
Gross‑to‑Net / 340BGtN 30.2%; 340B mix rising (~24% volume) GtN 30.4%; ~30% for year Ongoing headwind; no quarterly guidance provided
Capital Allocation$302M buyback in Q2; $204M remaining on $500M plan $99M buyback; new $750M authorization through 2026; cash ≈$1.6B Flexibility for R&D, BD, and buybacks maintained
Pipeline PrioritizationStop STELLAR‑305; start STELLAR‑311; wave‑two planning Wave‑two: meningioma and adjuvant/post‑adjuvant CRC trials expected 2026 Pre‑Q4: R&D Day set for Dec 10 with updates

Management Commentary

  • “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.” — Mike Morrissey, CEO .
  • “We are narrowing our total revenue and net product revenue guidance to the upper end… lowering our R&D expense guidance… and lowering our full‑year effective tax rate to 17%–18%.” — Chris Senner, CFO .
  • “Zanza + atezo had the first clinical success in a non‑MSI‑H 3L+ CRC population… median OS 10.9 months (ITT).” — Dana Aftab, EVP R&D .
  • “Cabometyx has rapidly become the market leader in [NET] 2L+ oral segment, with >40% new patient share… NET demand contributed ~6% of total demand in Q3.” — P.J. Haley, EVP Commercial .

Q&A Highlights

  • CRC launch positioning: Market is fragmented (~⅓ SUNLIGHT, ~⅓ TKIs, ~⅓ other); research suggests share gains from all competitors if approved; GI sales force expansion aims to maximize uptake .
  • STELLAR‑303 endpoints: ITT OS positive; NLM dual primary endpoint to final analysis mid‑2026; filing can proceed based on ITT hit; ITT is entire population, not a subgroup .
  • Comparator rationale (STELLAR‑304 nccRCC): Sunitinib is a relevant SOC comparator, widely used, including ex‑US .
  • Merck combo plans: Company confident belzutifan combinations with Zanza will proceed; no clinical‑trial sales in Q3 .
  • Capital allocation: Company expects to fund R&D, BD, and buybacks concurrently given revenue growth and prudent cost management .

Estimates Context

  • S&P Global consensus estimates for Q4 2025 EPS and revenue were not retrievable due to access limits at this time; we will update when available. Management does not guide quarterly figures but tightened FY25 ranges to the upper end in Q3, implying confidence into year‑end .

Key Takeaways for Investors

  • Cabo remains a durable growth engine with expanding 1L RCC presence and a successful NET launch that is already >40% new‑patient share and likely >$100M in 2025 revenue — a tangible growth driver into 2026 .
  • Zanza’s positive OS in non‑MSI‑H CRC is a differentiated data point; an NDA filing “ASAP” when government reopens is a near‑term catalyst, with commercial groundwork underway (GI sales build) .
  • FY25 guidance tightened toward the high end while R&D and tax rate were lowered, supporting operating leverage and capital returns (new $750M authorization) .
  • Gross‑to‑net remains a manageable headwind (~30% full‑year) given rising 340B mix; watch mix and rebate dynamics through Q4 .
  • Medium‑term optionality from wave‑two Zanza trials (meningioma, adjuvant/post‑adjuvant CRC) and early‑stage biotherapeutics (e.g., XB371, XB628) can broaden the franchise beyond Cabo .
  • Upcoming catalysts: Zanza NDA submission and R&D Day (Dec 10) for pipeline prioritization — both potential stock movers ahead of Q4 print .

Appendix: Source Availability

  • Q4 2025 8‑K 2.02 and earnings call transcript were not yet available in the document set searched (through 11/20/2025). We incorporated Q3 2025 earnings call (11/4/2025) and Q2 2025 press release (7/28/2025) for trend analysis – –.