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BEIGENE LTD(6160.HK):TURNING PROFITABLE IN 2025 WITH STRONG COMMERCIAL MOMENTUM AND HIGH-POTENTIAL PIPELINE

中银国际研究有限公司2025-02-28
  In 4Q24, Beigene's total revenue grew 78% YoY to US$1.13bn, with FY24 sales reaching US$3.81bn (+55% YoY). BRUKINSA remains the key growth driver, with FY24 sales of US$2.6bn (+105% YoY).
  Management issued 2025 revenue guidance of US$4.9-US$5.3bn and expects to achieve its first-ever positive GAAP operating profit (along with positive operating cash flow) in 2025. The late stage hematology pipeline is advancing rapidly. BGB-16673 (BTK CDAC) has begun PhIII trial in R/R CLL, positioning it as a global first-in-class BTK degrader, while sonrotoclax (BCL-2 inhibitor) is progressing towards registration trials in CLL and MCL. In solid tumours, key upcoming catalysts include PoC data readouts in 2025 for BGB-43395 (CDK4 for breast cancer), BGB-53038 (pan-KRAS for lung/colorectal), BGB-C9074 (B7- H4 ADC for breast/ovarian), BGB-60366 (EGFR CDAC for lung cancer), each with multi-billion-dollar potential. Reiterate BUY.
  Key Factors for Rating
  Robust 2024 results & 2025 guidance. BeiGene delivered robust growth in 4Q24, with total revenue reaching US$1.13bn (up 78% YoY) and full-year 2024 revenue of US$3.81bn (up 55% YoY) , driven largely by zanubrutinib's 4Q global sales which doubled to US$828m and FY2024 sales at US$2.6bn (a 105% YoY increase) . The strong product revenue momentum, coupled with a narrowing operating loss in 2024, are set to turn BeiGene profitable in 2025. Management issued 2025 revenue guidance of US$4.9-US$5.3bn and expects to achieve its first-ever positive GAAP operating profit (along with positive operating cash flow) in 2025. This inflection point reflects a transition towards sustainable growth funded by internal cash generation.
  Late-stage pipeline in hematology on track. BGB-16673 (BTK PROTAC degrader): A potential first-in-class BTK protein degrader entering PhIII. Over 500 patients have been treated in its trials to date, and pivotal studies in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) have already begun in February 2025. Notably, a head-to-head PhIII trial against Lilly's non- covalent BTK inhibitor pirtobrutinib is planned for late 2025, positioning BGB- 16673 to lead in BTK inhibitor-resistant B-cell malignancies. Sonrotoclax (BCL-2 inhibitor): A next-generation BCL-2 inhibitor in PhIII development for CLL aiming to challenge AbbVie's venetoclax. Sonrotoclax has entered pivotal-stage testing, including the PhIII CELESTIAL trial (1L CLL) now fully enrolled. In combination with BRUKINSA, it has shown no disease progression in treatment-naive CLL patients at 1.5-year follow-up (PhIb). Interim data from PhII studies in R/R CLL and mantle cell lymphoma (MCL) are expected in 2H25, with potential accelerated approval filings in those settings which could bring sonrotoclax to market ahead of schedule.
  Emerging pipeline poised to drive its next phase of growth. Beigene’s pipeline is expanding beyond hematologic cancers into solid tumours with innovative therapies across protein degraders (CDACs/PROTACs), antibody-drug conjugates (ADCs), and synthetic lethality approaches. Among its most promising assets, BGB-43395 (CDK4 inhibitor) aims to improve safety over existing CDK4/6 inhibitors in HR+ breast cancer, with PhI/II data expected in 1H25 and US$5bn+ peak sales potential. BGB-53038 (pan-KRAS inhibitor), designed to address multiple KRAS mutations, has PoC data expected in 2H25, targeting lung, colorectal, and pancreatic cancers (US$3bn+ market). BGB- C9074 (B7-H4 ADC), an antibody-drug conjugate for breast, ovarian, and endometrial cancers, expects initial clinical data in late 2025 with US$2bn+ peak sales potential, while BGB-60366 (EGFR CDAC) is a targeted degrader for EGFR- mutant NSCLC, designed to overcome osimertinib resistance, with PhI data in late 2025 (US$4bn+ market). BeiGene is also advancing synthetic lethality approaches with BGB-58067 (PRMT5/MAT2A inhibitor) targeting MTAP-deleted tumours, with PhI data expected in 2026 (US$3bn+ potential), and BGB-45035 (IRAK4 degrader) for hematologic malignancies and inflammation, with PhII trials beginning in 2025 (US$3bn+ opportunity).
  Key Risks for Rating
  1) Delay or failure in clinical development of key products; 2) patent disputes; 3) breakdown of key partnerships.
  Valuation
  Post results, we revised up our revenue forecasts for 2025E/26E and raised expenses estimation for 2026E. We rolled over our DCF model and derived a new TP (WACC: 11.8% and terminal growth 3.5%) of HK$183/US$293 for HK/ADR shares. Reiterate BUY.

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