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BeiGene, Ltd. (ONC)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was inflectional: total revenue rose 49% to $1.12B and BeiGene achieved positive GAAP net income ($1.27M) and operating profit, driven by BRUKINSA’s strength and margin expansion .
  • BRUKINSA global revenue grew 62% to $792M, with U.S. BRUKINSA sales $563M (+60% YoY) and Europe $116M (+73%), underscoring leading BTKi share and demand momentum .
  • Guidance maintained: FY 2025 revenue $4.9–$5.3B, GAAP gross margin mid‑80% range, positive full‑year GAAP operating income and positive cash from operations; unchanged vs prior quarter .
  • Estimates context: Q1 revenue modestly below consensus, but EPS materially beat as the company delivered GAAP profitability; set-up for pipeline catalysts and strengthened commercial execution .
  • Strategic catalysts include shareholder approval to rename to BeOne Medicines and redomicile to Switzerland, broadening global manufacturing and supply-chain resilience amid evolving tariff regimes .

What Went Well and What Went Wrong

What Went Well

  • BRUKINSA outperformance: global revenue +62% YoY to $791.7M; U.S. +60% to $563.3M; Europe +73.4% to $115.9M, reflecting leading new patient starts and widening market share .
  • Margin and cash-flow gains: GAAP product gross margin increased to 85.1% and operating cash flow rose to $44.1M, an improvement of $352.7M YoY, supporting GAAP profitability .
  • Management confidence and pipeline breadth: “We delivered another exceptional quarter, achieving our first quarter of GAAP profitability... multiple proof-of-concept readouts expected this year...” — John Oyler (CEO) ; reiterated robust late-stage heme and solid tumor pipeline milestones .

What Went Wrong

  • Collaboration revenue remains small ($8.7M) relative to product sales; tariff and supply-chain risks highlighted, requiring continued resiliency actions .
  • R&D and SG&A still sizable (GAAP R&D $481.9M; SG&A $459.3M), reflecting heavy investment intensity despite operating leverage; taxes also rose (income tax expense $19.6M) .
  • TEVIMBRA growth (+17.8% YoY to $171.2M) lags BRUKINSA’s pace; continued multi-region launch execution needed for acceleration .

Financial Results

Core Financials (Actuals)

MetricQ3 2024Q4 2024Q1 2025
Total Revenue ($USD Millions)$1,001.6*$1,127.8 $1,117.3
GAAP Net Income ($USD Millions)$(121.35)*$(151.88) $1.27
GAAP EPS per Share ($USD)$(1.17)*$(0.11) $0.00
GAAP EPS per ADS ($USD)$(2.41)*$(1.43) $0.01
Product Gross Margin % (GAAP)83.0%*85.6% 85.1%
Cash from Operations ($USD Millions)$188.4*$75.2 $44.1

Values marked with * retrieved from S&P Global.

Segment/Product Breakdown (Q1 2025 vs Q1 2024)

ProductQ1 2025 ($USD Millions)Q1 2024 ($USD Millions)YoY Change
BRUKINSA$791.664 $488.515 +62.1%
TEVIMBRA$171.164 $145.277 +17.8%
XGEVA (Amgen, China)$70.423 $43.381 +62.3%
BLINCYTO (Amgen, China)$23.906 $14.366 +66.4%
KYPROLIS (Amgen, China)$19.728 $14.111 +39.8%
POBEVCY$13.745 $16.633 −17.4%
Other$17.900 $24.635 −27.3%
Total Net Product Revenue$1,108.530 $746.918 +48.4%

Geographic Revenue (Q1 2025)

RegionTotal Revenue ($USD Millions)
U.S.$567.211
China$399.592
Europe$118.554
Rest of World$31.922
Total$1,117.279

Additional KPIs

KPIQ1 2025Prior-Year Q1 2024
SG&A as % of Product Sales (GAAP)41.4% 57.2%
GAAP Operating Income ($USD Millions)$11.1 $(261.3)
U.S. BRUKINSA Revenue ($USD Millions)$563.3 $351.5
Europe BRUKINSA Revenue ($USD Millions)$115.9 $66.8

Q1 2025 vs Consensus (S&P Global)

MetricQ3 2024Q4 2024Q1 2025
Revenue: Actual vs Consensus ($USD Millions)$1,001.6* vs $984.2*$1,127.8 vs $1,039.2*$1,117.3 vs $1,136.3*
Primary EPS: Actual vs Consensus ($USD)−1.15* vs −1.114*−0.11 vs −1.017*0.00 vs −0.74*

Values marked with * retrieved from S&P Global.

Notable outcomes:

  • Q1 EPS beat: Actual $0.00 vs −$0.74 consensus (Primary EPS) — bold positive surprise on profitability *.
  • Q1 revenue slight miss: $1,117.3M vs $1,136.3M consensus — modest underperformance on top line *.

Guidance Changes

MetricPeriodPrevious Guidance (as of Q4 2024)Current Guidance (Q1 2025)Change
Total RevenueFY 2025$4.9–$5.3B $4.9–$5.3B Maintained
GAAP Operating Expenses (R&D + SG&A)FY 2025$4.1–$4.4B $4.1–$4.4B Maintained
GAAP Gross Margin %FY 2025Mid‑80% Mid‑80% Maintained
Full‑Year GAAP Operating IncomeFY 2025Positive Positive Maintained
Cash Flow from OperationsFY 2025Positive Positive Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q3 2024)Current Period (Q1 2025)Trend
BRUKINSA leadership in CLLReinforced leadership; ALPINE superiority; BTKi breadth U.S. market leader by revenue; leading new patient starts; strong demand Improving
Fixed‑duration combo (zanu + sonro)CELESTIAL enrollment progress; head‑to‑head strategy TN CLL CELESTIAL 301 completed enrollment; plans for superiority vs VO; continued R/R trials Advancing
BTK CDAC (BGB‑16673)Registration‑enabling Phase 2 progressing; Phase 3 plans Initiated first Phase 3; head‑to‑head vs pirtobrutinib planned 2H25 Advancing
Solid tumor pipeline (CDK4, ADCs)Multiple PoC readouts expected 1H25 R&D Day to show early efficacy; aggressive enrollment; second‑line plans with SERD Building
Supply chain & tariffsU.S./EU/China footprint; Hopewell facility Proactive resilience; U.S. biologics production; API from Switzerland/Spain; tariff mitigation Resilient
Regulatory/legalOngoing litigation; risk disclosure USPTO invalidated Pharmacyclics patent claims; multiple TEVIMBRA approvals De‑risking/approvals

Management Commentary

  • “We delivered another exceptional quarter, achieving our first quarter of GAAP profitability with continued global revenue growth... we are well positioned — as we transition to BeOne Medicines and redomicile to Switzerland — to become one of the world’s most impactful oncology innovators.” — John Oyler, CEO .
  • Strategic manufacturing and tariff stance: “$800 million investment in our Hopewell, New Jersey manufacturing facility... commitment to regional manufacturing helps us mitigate potential risks and maintain reliable supply.” — CEO .
  • Financial discipline and cash generation: “We achieved a third consecutive quarter of positive operating cash flow... improved by $353 million vs Q1 2024.” — CFO .

Q&A Highlights

  • Breast cancer strategy: considering registration-enabling trial with PFS endpoint; exploring post‑ADC populations to de‑risk and accelerate data; potential neoadjuvant opportunities per KOL feedback .
  • BD approach: evaluating global or regional (e.g., Europe) partnerships to maximize pelareorep/pipeline value; continued interest from biopharma .
  • Medicare Part D redesign and seasonality: net pricing stable; Q1 seasonality (inventory drawdown, fewer shipping weeks) noted; TEVIMBRA U.S. launch building post recent approvals/NCCN listings .
  • Supply chain: Swiss API approval; efforts to broaden suppliers (Spain) and stockpile to ensure continuity .
  • IRA dynamics and competition: BRUKINSA differentiation vs IMBRUVICA/CALQUENCE; expectation to maintain leadership across earlier lines despite competitor developments .

Estimates Context

MetricQ3 2024 ActualQ3 2024 ConsensusQ4 2024 ActualQ4 2024 ConsensusQ1 2025 ActualQ1 2025 Consensus
Revenue ($USD Millions)$1,001.6*$984.2*$1,127.8 $1,039.2*$1,117.3 $1,136.3*
Primary EPS ($USD)−1.15*−1.114*−0.11 −1.017*0.00 −0.74*

Values marked with * retrieved from S&P Global.

  • Q1 EPS beat: Actual $0.00 vs −$0.74 consensus — strong profitability surprise driven by operating leverage and margin expansion *.
  • Q1 revenue slight miss: $1,117.3M vs $1,136.3M — modest underperformance; momentum remains underpinned by BRUKINSA demand and Europe/ROW scaling *.
  • Q4 revenue and EPS outcomes reflect seasonality dynamics and investment cadence; continued operating leverage into 2025 *.

Key Takeaways for Investors

  • BRUKINSA continues to drive the P&L with best‑in‑class execution and widening share in CLL; monitor upcoming mantle cell (MANGROVE) interim and fixed‑duration data with sonrotoclax as potential share catalysts .
  • Earnings quality improved: product GM in mid‑80s and SG&A intensity fell to 41.4% of product sales; sustained operating leverage supports full‑year GAAP profitability targets .
  • Guidance reaffirmation removes downside risk; watch quarterly cadence (seasonality, Part D redesign), but FY revenue trajectory intact at $4.9–$5.3B .
  • Supply chain and tariff resilience is a differentiator: U.S. biologics capacity and European API diversification mitigate geopolitical volatility; reduces risk to U.S. supply continuity .
  • Pipeline breadth offers multiple near‑term PoC readouts and late‑stage de‑risking in CLL (sonro, BTK CDAC), plus TEVIMBRA label expansion; potential valuation inflections tied to trial milestones and regulatory events .
  • Corporate transition to BeOne Medicines and Swiss redomicile may broaden the investor base and operational footprint; monitor execution milestones and governance updates .
  • Near‑term trading: expect focus on EPS sustainability and BRUKINSA demand trends; medium‑term thesis hinges on fixed‑duration data and BTK CDAC competitive positioning vs emerging BTK regimens .

Values marked with * retrieved from S&P Global.