BGNE Company Report

For the first three quarters of 2025, Beigene delivered $3.8 billion in product revenue, a 43% year-over-year increase, achieved $1.96 in GAAP diluted earnings per ADS, and generated $562 million in free cash flow.
BRUKINSA's quarterly revenue reached $1.2 billion in Q3 2025, marking a 51% year-over-year growth and establishing it as a global BTKi leader.
In 2025, Beigene achieved four regulatory approval submissions and initiated five Phase 3 studies, with Sonrotoclax receiving FDA breakthrough designation and first approvals. Key 2026 milestones include Sonrotoclax R/R MCL U.S. approval and a Phase 3 study initiation for ZS vs. AV in IL CLL.
The company showed significant improvement in free cash flow, transitioning from ($465 million) in Q1 2024 to a positive $354 million by Q3 2025.

Jan 13, 2026, 3:30 PM

Presentation

BeOne Medicines Reports Strong 2025 Performance and Outlines 2026 Pipeline Milestones

BGNE

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

BeOne Medicines achieved significant product revenue growth, GAAP profitability, and meaningful cash flow generation in 2025, generating over $350 million in free cash flow in Q3 and holding over $4 billion in cash. The company is committed to growth and margin expansion.
In 2025, BRUKINSA became the number one BTK inhibitor globally and in the U.S., setting a new standard for CLL treatment with six-year progression-free survival of 74% and overall survival of 84% (77% and 87% adjusted for COVID).
BeOne made significant pipeline progress in 2025, including Sonro receiving breakthrough designation and its first regulatory approvals. For 2026, the company anticipates phase three data for BURKINSA-MANGROVE, U.S. approval and initial global launches for Sonro, and an accelerated approval submission for its BTK CDAC trial in relapsed CLL. Five solid tumor programs also have external data catalysts this year.
The company aims to expand its presence in the $12 billion and growing CLL market with the combination of BRUKINSA and sonrotoclax (ZS), which is expected to fundamentally change the treatment paradigm for fixed-duration therapy.

Jan 13, 2026, 3:30 PM

Transcript

BeOne reports strong 2025 financial performance and pipeline advancements

BGNE

Product Launch

Revenue Acceleration/Inflection

New Projects/Investments

BeOne achieved significant product revenue growth, GAAP profitability, and meaningful cash flow generation in 2025.
Its foundational BTK inhibitor, BRUKINSA, became number one in the U.S. and globally in 2025, setting a new standard for efficacy and safety in CLL treatment with six-year progression-free survival and overall survival of 74% and 84% (or 77% and 87% adjusted for COVID).
In 2025, Sonro received breakthrough designation and priority review in the U.S. for relapsed MCL and its first-ever regulatory approvals, with four regulatory approval submissions in total.
The company generated over $350 million in free cash flow in Q3 and maintains a solid balance sheet with over $4 billion in cash.
BeOne expects a milestone-rich 2026, including phase three data for Brukinza-Mangrove in MCL, first US approval and initial global launches for Sonro, and accelerated approval submission for its pivotal phase 2 BTK CDAC trial in relapsed CLL.

Jan 13, 2026, 3:30 PM

Transcript

BeOne Provides 2025 Review and 2026 Outlook at J.P. Morgan Healthcare Conference

BGNE

Revenue Acceleration/Inflection

New Projects/Investments

Guidance Update

BeOne achieved significant product revenue growth, GAAP profitability, and meaningful cash flow generation in 2025.
BRUKINSA became the number one BTK inhibitor globally and in the U.S. in 2025, establishing a new standard for efficacy and safety in CLL treatment.
The company anticipates a milestone-rich 2026, including the first U.S. approval and global launches for Sonro in relapsed MCL, and an accelerated approval submission for its BTK CDAC in relapsed CLL.
BeOne reported a strong financial position with over $350 million in free cash flow in Q3 and over $4 billion in cash.
The company highlighted its R&D capabilities, having brought 15 new molecular entities into the clinic in the last 18 months and aiming to deliver 8 to 10 new molecular entities annually.

Jan 13, 2026, 3:30 PM

Transcript

B1 Highlights Strong Financial Performance and Pipeline Milestones

BGNE

Revenue Acceleration/Inflection

New Projects/Investments

Product Launch

B1 reported strong financial performance in Q3 2025, achieving $125 million in net income and $354 million in free cash flow, and is committed to generating GAAP operating income and cash flow for the full year.
The company's BTK inhibitor, Brukenza, is now the leading global revenue-generating BTK inhibitor and demonstrated a 74% milestone PFS at six years in CLL patients.
B1 expects initial market approvals for its BCL2 inhibitor, Synrodoclaix, in 2026, and for its BTK degrader in 2027.
B1's Q3 2025 revenue showed significant geographic diversity, with 52% from the United States, 12% from Europe (a 71% year-over-year growth), and the Rest of World growing 133% year-over-year.
The company plans to initiate a Phase 3 study for its CDK4 inhibitor in frontline HR positive HER2 negative breast cancer by the end of 2026, reflecting its broad pipeline in solid tumors.

Nov 17, 2025, 4:00 PM

Transcript

BeOne Discusses Profitability, Global Growth, and Pipeline Milestones

BGNE

Revenue Acceleration/Inflection

New Projects/Investments

Product Launch

BeOne has achieved profitability and its BTK inhibitor, Brukinsa, is now the leading global revenue-generating BTK, with $125 million in net income and $354 million of free cash flow reported in Q3 2025.
The company's revenue base is geographically diverse, with 52% from the United States, 12% from Europe (71% year-over-year growth), and Rest of World experiencing 133% year-over-year growth in Q3 2025.
BeOne anticipates initial approvals for its BCL2 inhibitor, sonrotoclax, in 2026, and a potential first market approval for its BTK degrader in 2027.
The company plans significant R&D investment, with more than 20 Phase 3 trials expected in 2026, including a Phase 3 study for its CDK4 inhibitor starting by the end of the first half of 2026.

Nov 17, 2025, 4:00 PM

Transcript

BeOne Discusses 2025 Financial Performance, Global Strategy, and Pipeline Milestones

BGNE

Revenue Acceleration/Inflection

New Projects/Investments

Product Launch

BeOne achieved profitability in 2025 and reported $125 million in net income and $354 million in free cash flow for Q3 2025, with a commitment to GAAP operating income and cash flow generation for the full year.
The company's global revenue diversification in Q3 2025 showed 52% from the United States, 12% from Europe (up 71% year-over-year), and 133% year-over-year growth in the rest of the world.
BeOne's unique "Global Superhighway" infrastructure, comprising 6,000 people across manufacturing and clinical trials in 40-50 countries, enables rapid and cost-effective drug development, leading to 16 new molecular entities entering the clinic in the last two years.
Key pipeline developments include BRUKINSA leading global BTK revenue , expected initial approvals for Sonrotoclax in 2026, and the BTK degrader in 2027. BeOne plans to initiate more than 20 phase III trials in 2026, including a CDK4 inhibitor for breast cancer.

Nov 17, 2025, 4:00 PM

Transcript

BeOne Medicines Discusses Product Pipeline and Brukinsa Growth

BGNE

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

BeOne Medicines (BGNE) has achieved profitability this year and its anchor product, Brukinsa, has captured the leading market share in the BTK inhibitor market, with 47% year-over-year growth in the United States and 71% year-over-year growth in Europe.
The company is advancing its BCL-2 inhibitor, sonrotoclax, which received breakthrough designation in relapsed refractory MCL and plans for global filing later this year, with data to be presented at ASH. It is also being developed for CLL in combination with Brukinsa and for multiple myeloma.
BeOne is developing a BDK CDAC degrader, with a potentially pivotal phase II cohort fully enrolled and data expected in the first half of next year, showing an 84% response rate and 79% 12-month landmark PFS in heavily pretreated patients.
A CDK4/6 inhibitor for solid tumors is also in the pipeline, with a phase III trial planned for first-line breast cancer next year, demonstrating a similarly high response rate as Pfizer's CDK4 inhibitor.

Nov 10, 2025, 2:30 PM

Transcript

BeOne Medicines Highlights First-Time Profitability and Pipeline Progress

BGNE

Revenue Acceleration/Inflection

Product Launch

New Projects/Investments

BeOne Medicines (BGNE) has achieved profitability for the first time in its history and is recognized as one of the fastest-growing large biotech companies.
The company's anchor product, Brukinsa, a BTK inhibitor, is demonstrating strong commercial performance with 47% year-over-year growth in the US and 71% year-over-year growth in Europe, and has shown unprecedented durability with 74% landmark PFS at 72 months in Sequoia data.
The pipeline includes sonrotoclax (BCL2 inhibitor), which received breakthrough designation in relapsed refractory MCL and is expected to be filed globally later this year based on data to be presented at ASH. A phase 3 study for sonrotoclax in multiple myeloma is also planned for next year.
The BDK CDAC (degrader) has shown an 84% response rate and 79% 12-month landmark PFS in heavily pretreated patients, with pivotal phase 2 data for registration expected in H1 next year.
BeOne is also advancing a CDK4/6 inhibitor into a phase 3 trial next year for first-line breast cancer, having significantly accelerated its development to within roughly a year of competitors.

Nov 10, 2025, 2:30 PM

Transcript

BeOne Medicines Achieves Profitability Amid Strong Product Growth and Deep Pipeline Advancements

BGNE

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

BeOne Medicines has achieved profitability for the first time in its history.
Brukinsa, the company's anchor product, holds a leading market share in the BTK inhibitor market, demonstrating 47% year-over-year growth in the United States and 71% in Europe.
The company has a deep product pipeline, having advanced 10 internally developed New Molecular Entities (NMEs) into the clinic in 2024, with a total of 16 to date.
Sonrotoclax, a BCL2 inhibitor, received breakthrough designation in relapsed refractory MCL and is slated for global filing later this year, with data to be presented at ASH.
BGB-16673, a BDK CDAC degrader, has a potentially pivotal phase two cohort fully enrolled, with data expected in the first half of next year for registration in relapse refractory CLL.