BeOne Medicines (ONC) Leerink Global Healthcare Conference 2025 summary

Strategic and operational highlights

• Achieved 73% product growth in 2024, with revenue guidance for 2025 set at $4.9–$5.3 billion.

• Expanded international footprint, now with over 60% of revenue from US and Europe, and opened a biologics facility in New Jersey.

• Announced plans to re-domicile to Switzerland and change name to BeOne Medicines, effective first half of 2025.

• Achieved three consecutive quarters of non-GAAP operating income and two quarters of positive cash flow from operations.

• Maintains triple listing in US, Hong Kong, and China, balancing growth investment with operating discipline.

Hematology franchise and Brukinza performance

• Brukinza became the leading BTK inhibitor in the US, surpassing Calquence in total dollar sales in Q4.

• Holds over 50% new patient start share in CLL, with approvals and launches expanding in the EU and globally.

• Clinical preference driven by selectivity, potency, and strong head-to-head data versus ibrutinib.

• Fixed duration regimens are a strategic focus, with promising early results for Sonro plus Xanu in all-comers populations.

• Phase 3 Celestial study in treatment-naive CLL completed enrollment; MRD data expected in about one year.

Pipeline and innovation

• 13 new molecular entities entered the clinic in 2024, with proof-of-concept readouts expected in 2025–2026.

• BTK degrader program advancing to two randomized phase 3 studies in 2024, with additional combination studies planned.

• CDK4 inhibitor program rapidly enrolling globally, aiming for front-line and second-line registrational studies.

• Internal ADC portfolio progressing, with first clinical data for B7-H4 ADC to be shared at ASCO.

• PRMT5 and MAT2A inhibitor programs advancing, with combination studies set to begin in Q3 2024.

• EGFR degrader in early phase dose escalation, targeting broad resistance and initiating mutations.