BeOne Medicines Ltd. Q3 FY2025 earnings call

Financial Performance - Revenue reached $1.4 billion, up 41% y-o-y; GAAP earnings per ADS were $1.09; generated over $350 million of free cash flow. - BRUKINSA continued strong performance, growing 51% and becoming global value share leader in BTK market; Sonro received FDA breakthrough designation in relapsed/refractory mantle cell lymphoma. ### Hematology - BRUKINSA in Phase III SEQUOIA trial showed 74% landmark PFS at 6 years in first-line CLL. - BeOne has fully owned potentially best-in-class assets across 3 foundational MOAs in CLL: BRUKINSA, sonro, and BTK CDAC. ### Solid Tumor Pipeline - Achieved clinical proof-of-concept for several innovative programs including CDK4 inhibitor, B7-H4 ADC, PRMT5 inhibitor under GPC3x41BB bispecifics. - CDK4 inhibitor plans to initiate Phase III trial in first-line BC in H1 2026; B7-H4 ADC completed dose escalation; PRMT5i Inhibitor accelerated into frontline lung and pancreatic cancer. ### Development Global Super Highway - Built a global organization of nearly 6,000 colleagues across clinical development and manufacturing, seen as unique and critical to R&D returns.

In the third quarter, revenue reached $1.4 billion, representing 41% year-on-year growth. BRUKINSA grew 51% and exceeded $1 billion in quarterly global revenue for the first time, now the global value share leader among the BTK market. TEVIMBRA reported a 17% increase. In-licensed products grew 17% year-over-year, with a 31% growth from the Amgen in-licensed asset portfolio. By region, the U.S. remained the largest market with $743 million in revenue, up 47% year-over-year; China revenue totaled $435 million, a 17% increase; Europe contributed $167 million, with 71% year-over growth; rest of world markets grew 133%. Gross margin improved to 86% from approximately 83% in the prior year.

• Updated full year revenue guidance to between $5.1 billion and $5.3 billion. - Gross margin guidance remains in the mid- to high 80% range. - Updated operating expense guidance to be between $4.1 billion to $4.3 billion; expects positive GAAP operating income and positive free cash flow for the year. - For 2026, consider U.S. BTK class seasonality patterns like inventory increases at year-end and lower shipment gains in Q1 2026; detailed 2026 guidance to be provided on Q4 earnings call in February.

• BRUKINSA's Phase III MAMRO study in treatment-naive mantle cell lymphoma delayed to H1 2026 due to slower-than-anticipated event rate. - Potential delays in product approvals, e.g., sonro's accelerated approval in relapse/refractory mantle cell lymphoma and CRO in China. - Strategic realignment of some solid tumor programs like B7-H3 ADC and Pro-IL15 due to competitive landscape and data, reflecting disciplined development strategy.

Q: BRUKINSA's global leader, any update on Europe launch and CDAC data for CLL?

A: In Europe, BRUKINSA growth is strong but total acala in Europe is flattening; regarding CDAC data, it's a single-arm study likely based on ORR and DOL depending on agency discussion.

Q: Early stage pipeline proof-of-concept, any details on other assets and if they'll progress to Phase III?

A: For early programs, clear criteria for success based on preclinical data; some programs like CDK4, B7-H4, PRMT5, GPC3x41BB are advancing to Phase III, others continue exploration based on data maturity.

Q: CDK4 inhibitor decision to focus on first line, and zanu plus sonro trial signpost?

A: Deprioritized second-line due to competitive landscape and strong frontline data; zani plus sonro trial is PFS events-driven, also monitoring uMRD rate for earlier look.