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BeOne Medicines Ltd. (ONC)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 delivered strong growth and profitability: revenue $1.41B (+41% Y/Y), GAAP diluted EPS per ADS $1.09, non-GAAP diluted EPS $2.65; free cash flow $354M. Strength was driven by BRUKINSA global leadership and mix-led gross margin expansion .
  • Results beat Wall Street: EPS beat consensus $1.09 vs $0.86*, revenue beat $1.41B vs $1.36B*, with 9–10 estimates tracked [GetEstimates].
  • Guidance raised/optimized: FY25 total revenue lifted to $5.1–$5.3B (from $5.0–$5.3B); GAAP OpEx tightened to $4.1–$4.3B (from $4.1–$4.4B); gross margin and operating income expectations maintained .
  • Strategic catalysts: FDA Breakthrough Therapy Designation for sonrotoclax in R/R MCL and participation in Project Orbis; TEVIMBRA perioperative NSCLC expansion and new ESMO data; Royalty Pharma royalty sale up to $950M on IMDELLTRA ex-China .
  • Stock reaction: Shares rose ~4% premarket post-earnings as investors digested the beat and guidance update .

What Went Well and What Went Wrong

  • What Went Well

    • BRUKINSA outperformance: Global BRUKINSA revenue hit ~$1.0B (+51% Y/Y), with U.S. sales $739M (+47% Y/Y) and Europe $163M (+68% Y/Y), supported by leading new patient share and differentiated clinical profile .
    • Margin expansion and operating leverage: GAAP gross margin reached 85.9% (+310 bps Y/Y) on higher BRUKINSA mix and productivity gains; GAAP income from operations swung to $163M from a loss; adjusted operating income $341M .
    • Confidence and pipeline momentum: Management emphasized BRUKINSA’s class leadership and highlighted late-stage assets (sonrotoclax, BTK CDAC BGB-16673) targeting broad CLL utility, with 74% 6-year landmark PFS data for first-line CLL to be presented at ASH, reinforcing the long-term narrative .

  • What Went Wrong

    • Elevated OpEx as growth investment continues: GAAP R&D $524M (+6% Y/Y) and SG&A $529M (+16% Y/Y); total GAAP OpEx $1.053B (+11% Y/Y), reflecting global commercial expansion and pipeline advancement .
    • Impairment and OI&E drag: Other income (expense), net was -$19.0M in Q3 and impairment of equity investments of $18.7M factored into non-GAAP adjustments; income tax expense remained notable at $22.3M .
    • Seasonality and pricing sensitivities: Management flagged U.S. seasonality and only a modest net pricing benefit in BRUKINSA, tempering the pace of sequential growth expectations into Q4 .

Financial Results

  • Quarter-over-quarter and year-over-year comparisons, with margins:
MetricQ1 2025Q2 2025Q3 2025
Total Revenue ($USD)$1,117,279,000 $1,315,300,000 $1,412,284,000
GAAP Diluted EPS per ADS ($)$0.01 $0.84 $1.09
Non-GAAP Diluted EPS per ADS ($)$1.22 $2.25 $2.65
GAAP Gross Margin (%)85.1% 87.4% 85.9%
GAAP Net Income ($USD)$1,270,000 $94,320,000 $124,841,000
Free Cash Flow ($USD)—$219,772,000 $354,469,000
  • Q3 actuals vs Wall Street consensus:
MetricConsensusActual
Primary EPS (GAAP diluted per ADS)$0.86*$1.09
Revenue ($USD)$1,363,952,190*$1,412,284,000
# of EPS Estimates9*—
# of Revenue Estimates10*—

Values with * retrieved from S&P Global (Capital IQ).

  • Segment/product/geography KPIs:
KPI ($USD Millions)Q1 2025Q2 2025Q3 2025
U.S. Product Revenue$563 $685 $743
BRUKINSA U.S. Sales$563 $684 $739
BRUKINSA Europe Sales$116 $150 $163
TEVIMBRA Sales$171 $194 $191
Product Revenue (Global)$1,108.53 $1,302.076 $1,395.013
Other/Collaboration Revenue$8.749 $13.224 $17.271
  • Non-GAAP adjustments (Q3):
    • Share-based compensation: $140.786M; depreciation: $35.730M; amortization: $1.554M; impairment of equity investments: $18.722M; tax effect of adjustments: $(17.044)M .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025$5.0–$5.3B $5.1–$5.3B Raised low end
GAAP Operating Expenses (R&D + SG&A)FY 2025$4.1–$4.4B $4.1–$4.3B Lowered high end
GAAP Gross Margin %FY 2025Mid to high-80% Mid to high-80% Maintained
GAAP Operating IncomeFY 2025Positive Positive Maintained
Cash FlowFY 2025Positive free cash flow Positive free cash flow Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1/Q2)Current Period (Q3)Trend
BRUKINSA leadership in BTKiQ1: Became overall BTKi market share leader in U.S.; new patient starts lead . Q2: Leading new patient share; tablet formulation approvals (FDA/EC) .CEO reiterated global leadership; ASH data with 74% 6-year landmark PFS in 1L CLL; robust demand and modest pricing benefit Strengthening
Sonrotoclax (BCL2)Q1: Phase 3 initiations; filings in China (CLL/MCL) . Q2: Priority reviews in China; global Phase 3 with CD20 .FDA Breakthrough Therapy Designation; Project Orbis participation; positive topline R/R MCL data Accelerating
BTK CDAC (BGB-16673)Q1: Phase 2 R/R CLL ongoing; Phase 3 vs physician’s choice initiated . Q2: EMA PRIME; Phase 3 global/China in R/R CLL; R/R WM Phase 2 .Global Phase 3 head-to-head vs pirtobrutinib in R/R CLL enrolled Advancing
TEVIMBRA expansionQ1: Multiple FDA/EC approvals and dosing flexibility; ESCC and ES-SCLC approvals . Q2: EC approvals (nasopharyngeal carcinoma; ES-SCLC); perioperative NSCLC positive CHMP .EC approval perioperative NSCLC; new ESMO 2025 data (RATIONALE-307/-312) supporting OS benefits; HPK1 combo early data Broadening
Margin and OpExQ1: GAAP GM 85.1%; SG&A 41% of product sales . Q2: GAAP GM 87.4%; SG&A 41% of product sales .GAAP GM 85.9%; SG&A as % of product sales 38% (improved leverage) Operating leverage improving
Macro/seasonalityQ2: Positive free cash flow outlook .Management highlighted U.S. seasonality; reaffirmed FY revenue range Seasonality watch

Management Commentary

  • “These strong financial results reinforce our position as a global oncology leader with exceptional topline growth and a strong balance sheet. BRUKINSA is now the global revenue leader in the BTKi class...” — John V. Oyler, Co-Founder, Chairman & CEO .
  • “GAAP earnings per ADS were $1.09... We generated over $350 million of free cash flow during the quarter.” — Management, Q3 earnings call .
  • “Gross margin... increased due to a proportionally higher sales mix of global BRUKINSA... and production productivity improvements...” .

Q&A Highlights

  • Market dynamics and seasonality: CFO underscored confidence in the updated FY25 range ($5.1–$5.3B) while noting U.S. seasonality in Q4 intake; teams executing well locally .
  • CLL treatment paradigm: Management highlighted future opportunities for fixed-duration regimens (e.g., BTK + BCL2), degrader utility in later lines, and sustained BTK mono leadership .
  • Pipeline clarifications: Team discussed ongoing pivotal plans for BTK CDAC and timelines to pivotal data/filings in 2026; reiterated Breakthrough status for sonrotoclax and Orbis participation .

Estimates Context

  • Q3 2025 beat on both lines: EPS $1.09 vs $0.86*; revenue $1.41B vs $1.36B*, supported by BRUKINSA strength and gross margin expansion [GetEstimates].
  • With 9 EPS and 10 revenue estimates*, consensus appears to have under-modeled mix benefits and U.S./Europe BRUKINSA momentum [GetEstimates].
  • Forward estimates likely to adjust upward for FY revenue and non-GAAP EPS, while OpEx expectations may reflect continued commercial investments and R&D scale-up .

Values with * retrieved from S&P Global (Capital IQ).

Key Takeaways for Investors

  • Momentum intact: Strong Q3 execution, guidance raised on the low end; BRUKINSA commercial durability and mix drive margin leverage — supportive of upward estimate revisions .
  • Near-term trading: Positive beat-and-raise setup, ASH visibility (CLL long-term data) and BTD headline for sonrotoclax offer catalysts; watch U.S. seasonality commentary for Q4 cadence .
  • Medium-term thesis: Late-stage hematology franchise (BRUKINSA, sonrotoclax, BTK CDAC) positions ONC for CLL paradigm leadership with broad utility; TEVIMBRA adds durable growth across lung and other indications, with continued EU/Japan expansion .
  • Financial strength: $4.11B cash, positive FY free cash flow target, and improved SG&A efficiency (38% of product sales in Q3) provide flexibility for BD and pipeline investment .
  • Risk checks: OpEx growth continues; OI&E/impairments can create quarterly volatility; regulatory timelines and competitive dynamics (noncovalent BTKi, BCL2 competitors) warrant monitoring .
  • Corporate actions: Royalty Pharma transaction (up to $950M) enhances balance sheet optionality; patent resolution with Pharmacyclics removes an overhang .
  • Watchlist events: TEVIMBRA approvals/indication expansions, sonrotoclax confirmatory Phase 3 progress, BTK CDAC pivotal enrollment/data flow — all potential stock-moving updates .
Sources accessed:
- Q3 2025 8-K 2.02 earnings press release (Ex. 99.1) **[1651308_0001628280-25-049821_bgne-20251106.htm:0]**–**[1651308_0001628280-25-049821_exhibit991-q32025earningsr.htm:9]**
- Prior quarters’ 8-K 2.02: Q2 2025 **[1651308_0001651308-25-000131_bgne-20250806.htm:0]**–**[1651308_0001651308-25-000131_exhibit991-q22025earningsr.htm:9]**; Q1 2025 **[1651308_0001651308-25-000074_bgne-20250507.htm:0]**–**[1651308_0001651308-25-000074_exhibit991-q12025earningsr.htm:8]**
- Q3 related press releases: Sonrotoclax BTD **[1651308_d44b28f737db4a358b7050f928c8fbc6_0]**–**[1651308_d44b28f737db4a358b7050f928c8fbc6_3]**; TEVIMBRA ESMO data **[1651308_7b23ecb178404debb62d1cdfc77c0564_0]**–**[1651308_7b23ecb178404debb62d1cdfc77c0564_4]**
- Q3 earnings call transcript: Seeking Alpha/Quartr/MarketScreener/Yahoo/GuruFocus **[https://seekingalpha.com/article/4839255-beone-medicines-ag-onc-q3-2025-earnings-call-transcript]** **[https://finance.yahoo.com/quote/688235.SS/earnings/688235.SS-Q3-2025-earnings_call-371199.html/#:~:text=BeOne%20Medicines%20reported%20Q3%202025,pivotal%20readouts%20and%20regulatory%20filings.&text=Good%20day%2C%20everyone.]** **[https://www.marketscreener.com/news/transcript-beone-medicines-ag-q3-2025-earnings-call-nov-06-2025-ce7d5cd2d089f027]** **[https://www.gurufocus.com/news/3200234/q3-2025-beone-medicines-ag-earnings-call-transcript?mobile=true]**
- Market reaction detail **[https://www.investing.com/news/transcripts/earnings-call-transcript-beone-medicines-q3-2025-beats-expectations-with-strong-eps-93CH-4338606]**
- Consensus estimates (SPGI/Capital IQ) [GetEstimates]