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BeiGene, Ltd. (BGNE)·Q3 2024 Earnings Summary

Executive Summary

  • Total revenue reached $1.00B (+28% YoY) on strong BRUKINSA performance; product revenue rose 67% to $993M; GAAP operating loss narrowed to $120M and non-GAAP operating income was positive for a second consecutive quarter at $66M .
  • BRUKINSA global sales were $690M with continued U.S. CLL share gains; TEVIMBRA sales were $163M with expanding U.S./EU launches and new approvals across multiple countries .
  • Gross margin (GAAP) was 83% (down 1 pt YoY) due to $17M accelerated depreciation tied to upgrading tislelizumab manufacturing; adjusted gross margin improved to 85% on higher BRUKINSA mix .
  • Catalysts: ASH 2024 data readouts (SEQUOIA 5-year follow-up; BOVen uMRD durability), CELESTIAL Phase 3 enrollment completion (Q1’25), and multiple Phase 3 starts (1H’25) in hematology .

What Went Well and What Went Wrong

  • What Went Well

    • BRUKINSA momentum: U.S. sales $504M (+87% YoY) with share gains in CLL new patient starts; Europe BRUKINSA sales $97M (+217% YoY) on broad market share gains .
    • Profitability progress: non-GAAP operating income of $66M (vs. $(16)M) and positive operating cash flow of $188M; SG&A as % of product sales improved to 46% (from 61%) as leverage builds .
    • CEO tone: “Our exceptional third-quarter results underscore the Company’s global oncology leadership… BRUKINSA… is now the leader in new patient starts in both frontline and R/R CLL…” .
  • What Went Wrong

    • GAAP gross margin contracted 1 pt YoY due to $17M accelerated depreciation during tislelizumab line transition; similar cost expected in Q4 .
    • GAAP bottom line remained a net loss of $121M, partly reflecting a very strong prior-year non-operating gain from the BMS arbitration and deferred Novartis revenue recognized in Q3’23 (tough comp) .
    • R&D and SG&A (GAAP) increased 9% and 24% YoY, respectively, as BeiGene invests in late-stage programs and global launches (though leverage improved vs sales) .

Financial Results

Revenue, EPS, margins vs prior periods

MetricQ1 2024Q2 2024Q3 2024
Total Revenues ($M)$751.652 $929.166 $1,001.599
Net Product Revenues ($M)$746.918 $921.146 $993.447
Collaboration Revenues ($M)$4.734 $8.020 $8.152
GAAP Loss from Operations ($M)$(261.348) $(107.161) $(120.265)
Adjusted Income (Loss) from Operations ($M)$(147.341) $48.464 $65.630
GAAP Net (Loss) Income ($M)$(251.150) $(120.405) $(121.350)
Diluted EPS per ADS ($)$(2.41) $(1.15) $(1.15)
Gross Margin % (GAAP)83% 85% 83%
Cash from Operations ($M)$(309) $(96) $188

Segment and brand highlights

MetricQ1 2024Q2 2024Q3 2024
BRUKINSA Global Revenue ($M)$489 $637 $690
TEVIMBRA (tislelizumab) Sales ($M)$145 $158 $163
U.S. Product Revenue ($M)$351 $479 $504

KPIs and efficiency

KPIQ1 2024Q2 2024Q3 2024
SG&A as % of Product Sales57% 48% 46%
Total Operating Expenses (GAAP, $M)$888.065 $898.195 $951.402

Notes:

  • Q3 GM% decline reflects $17M accelerated depreciation on tislelizumab line upgrade; adjusted GM rose to 85% on favorable BRUKINSA mix .
  • Q3 operating cash flow improved on non-GAAP operating profitability and working capital seasonality .

Guidance Changes

BeiGene did not provide numerical financial guidance in the Q3 2024 press release. Pipeline timing updates are summarized below.

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CELESTIAL (sonrotoclax + BRUKINSA) TN CLL Enrollment CompletionQ1 2025Enrollment completion estimated Q1 2025 New timing detail
Phase 3 Starts (R/R CLL; R/R MCL)1H 20254Q24/1Q25 window (earlier narrative) 1H 2025 Clarified/shifted window
NMEs Entering Clinic in 2024FY 202410+ target; on track (Q2) On track to 10+ by year-end; 8 YTD with 4 in Q3 Maintained

Earnings Call Themes & Trends

(Transcript for Q3 2024 was not available in the document search; themes below reflect cross-quarter disclosures from press releases.)

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2024)Trend
BRUKINSA leadership in CLLQ1: BTKi class leader in U.S. new-patient share; EU reimbursement expansion . Q2: U.S. +114% YoY; EU +209% YoY .U.S. sales $504M (+87% YoY); EU BRUKINSA $97M (+217% YoY); leader in CLL new patient starts .Accelerating
TEVIMBRA global rolloutQ1: EU NSCLC approvals; U.S. ESCC approval; multiple filings . Q2: U.S. deferral on ESCC 1L; China/ASCO data; $158M sales .$163M sales; U.S. commercial availability (2L ESCC); EU launches; CHMP positive opinions and new country approvals .Broadening
Operating leverageQ1: GM 83%; leverage improving . Q2: GM 85%; non-GAAP op income positive .GM 83% GAAP (85% adjusted); 2nd straight positive non-GAAP op income; CFO +$188M .Improving (with temporary GM headwind)
Pipeline velocity (NMEs)Q1: multiple platforms (ADC/CDAC/PRMT5/KRAS) moving to clinic 2H’24 . Q2: >15 investigational molecules; several entered clinic .Four NMEs entered clinic in Q3 (eight YTD); on track for 10+ in 2024 .Accelerating
Manufacturing/operationsQ2: Opened $800M NJ biologics facility; redomicile plan to Switzerland .Accelerated depreciation from moving tislelizumab to larger lines; similar impact expected in Q4 .Transitioning to scale (near-term cost)
Regulatory/legalQ1: USPTO post-grant review on Pharmacyclics patent; favorable review acceptance .Stable

Management Commentary

  • “Our exceptional third-quarter results underscore the Company’s global oncology leadership… BRUKINSA… is now the leader in new patient starts in both frontline and relapsed/refractory (R/R) CLL… We are laying the foundation for future franchises in breast, lung, and gastrointestinal cancers across three signature platform technologies including multi-specific antibodies, protein degraders, and antibody-drug conjugates.” — John V. Oyler, Co-Founder, Chairman and CEO .
  • “Gross margin… decreased on a GAAP basis due to accelerated depreciation expense of $17 million… The adjusted gross margin percentage… increased primarily due to proportionally higher sales mix of global BRUKINSA…” .

Q&A Highlights

  • The Q3 2024 earnings call transcript was not available in the document repository at time of analysis. BeiGene’s IR site lists Q3 2024 earnings materials; we will update Q&A themes once the transcript is accessible .

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2024 revenue and EPS was unavailable due to a CIQ mapping issue in our S&P Global feed; as a result, we cannot provide a beat/miss analysis vs. consensus at this time. We searched for “Revenue Consensus Mean” and “Primary EPS Consensus Mean” for Q3 2024 but could not retrieve data via S&P Global due to the mapping error. We will refresh and provide comparisons upon resolution.
  • Press release context: Q3 total revenue was $1.00B, product revenue $993M, with positive non-GAAP operating income; GAAP net loss was $121M .

Key Takeaways for Investors

  • BRUKINSA is the primary growth engine with durable CLL leadership; $690M global in Q3 and strong U.S./EU momentum underpin continued top-line expansion .
  • Operating leverage is materializing: second straight quarter of positive non-GAAP operating income and improved SG&A intensity; watch for sustained non-GAAP profitability and cash generation as the revenue base scales .
  • Near-term gross margin headwind from accelerated depreciation is transitory; adjusted GM improvement highlights favorable mix (BRUKINSA) .
  • TEVIMBRA is broadening geographically with incremental approvals and launches; continued execution here diversifies revenue beyond hematology .
  • 2024 is a pivotal pipeline year: four NMEs entered the clinic in Q3 (eight YTD), on track for 10+ by year-end; expansive platforms (ADC, degraders, multispecifics) support multi-franchise ambition .
  • Upcoming catalysts: ASH 2024 long-term BRUKINSA datasets; CELESTIAL enrollment completion in Q1’25; multiple Phase 3 starts in 1H’25 (R/R CLL, R/R MCL) .
  • Trading lens: Focus on ASH quality/read-through to CLL share, sequential non-GAAP profitability, and cadence of EU/US launches; resolution of temporary GM headwinds and sustained CFO strength would be stock-supportive .

Sources:

  • Q3 2024 8-K and press release: revenues, P&L, cash flow, GM %, product and regional disclosures, pipeline/catalysts .
  • Q2 2024 press release: revenues, brand/geography, GM %, operating expenses, narrative .
  • Q1 2024 press release: revenues, brand/geography, GM %, operating leverage progress .
  • Business Wire distribution of Q3 2024 press release .
  • IR events page for Q3 2024 materials .