China-originated global pharma BeOne Medicines last week released Q2 and H1 2025 financials, reporting for the first time the much-anticipated profitability. In Q2, BeOne achieved a GAAP net profit of USD 94 million, a USD 215 million improvement compared to the loss in the same period last year, primarily driven by "revenue growth and improved operating leverage". Notably, BeOne also generated USD 220 million in free cash flow in Q2.
Profitability status was largely due to the continued expansion of BTK inhibitor BRUKINSA® (zanubrutinib) HCP. In fact, based on Brukinsa’s leading position in the US market and its continued expansion in Europe and other key global markets in the first semester, BeOne raised its full-year total revenue guidance to between RMB 35.8 and 38.1 billion and revised its cash flow guidance from "positive operating cash flow for the full-year" to "positive free cash flow for the full-year", demonstrating confidence in profitability driven by product revenue.
Blockbuster Continues to Drive Growth
According to the announcement, BeOne’s revenue reached USD 1.3 billion in Q2 2025, up 42% year-on-year (YoY), while H1 total revenue hit USD 2.4 billion, up 45%.
Brukinsa was the top contributor to this strong performance: in Q2 alone, the drug’s global revenue reached USD 950 million, up 49% YoY, exceeding the overall product revenue growth rate.
Broken down by geography, Brukinsa’s US sales in Q2 2025 were USD 684 million (+43% YoY), while its market share in Europe also increased, with Q2 sales reaching USD 150 million.
Since winning a head-to-head trial against Johnson & Johnson and AbbVie’s Imbruvica (ibrutinib), Brukinsa has established itself as the best-in-class BTK inhibitor, maintaining its lead in new patient market share aided by its broader approved indications. In the announcement, BeOne stated that Brukinsa saw significant demand growth across all indications in Q2, with net pricing also providing a modest benefit.
On the commercial front, Brukinsa also made new progress: in Q2, it was newly included or expanded in reimbursement lists in five markets, while its new film-coated tablet formulation was approved by US regulator the Food and Drug Administration (FDA) for all approved indications, and received a positive opinion from the European Medicines Agency (EMA).
Correspondingly, continued investment in global commercial expansion led to an increase in selling, general, and administrative expenses (SG&A) expenses in Q2. However, as core product Brukinsa scaled up, SG&A expenses as a percentage of product revenue actually declined, dropping to 41% in Q2 2025 from 48% in the same period last year.
Meanwhile, thanks to Brukinsa’s higher contribution to global sales and improved production efficiency for both Brukinsa and checkpoint inhibitor TEVIMBRA® (tislelizumab-jsgr) HCP, BeOne’s GAAP gross margin further improved to 87.4% in Q2 2025, up from 85.0%.
Clearly, the profitability driven by Brukinsa’s expansion is not a one-off event but reflects optimisation from operating expense ratios to gross margins, marking BeOne’s official entry into black-numbers territory.
Raised Full-Year Guidance: Marching Toward Global Oncology Leadership
In view of Brukinsa’s continued global sales growth, investment firm Nomura Securities International, Inc. last month projected that BeOne would record a USD 119 million profit in H2 and achieve full-year revenue of USD 4.9 billion to USD 5.3 billion, likely meeting its full-year sales and operating profit guidance. In last week’s half-year report, BeOne raised its 2025 revenue guidance to RMB 35.8 to 38.1 billion (USD 5.0 to 5.3 billion), closely aligning with Nomura’s forecast.
In view of Brukinsa’s continued global sales growth, investment firm Nomura Securities International, Inc. last month projected that BeOne would record a USD 119 million profit in H2 and achieve full-year revenue of USD 4.9 billion to USD 5.3 billion, likely meeting its full-year sales and operating profit guidance. In last week’s half-year report, BeOne raised its 2025 revenue guidance to RMB 35.8 to 38.1 billion (USD 5.0 to 5.3 billion), closely aligning with Nomura’s forecast.
A closer look reveals that BeOne’s confidence stems from its broad innovative product portfolio.
On one hand, its stalwart products will keep getting stronger. Flagship product Brukinsa will maintain its leading position in the US while continuing to expand globally; Tevimbra/Tizveni was newly included in reimbursement lists in 20 markets in Q2, including Australia, Europe and Japan, while achieving milestones such as European Commission (EC) approval for first-line treatment of extensive-stage small cell lung cancer (SCLC) and combination therapy for metastatic or recurrent nasopharyngeal carcinoma. These developments will further fuel the company’s growth.
On the other hand, while continuing to advance in haematology, BeOne has achieved breakthroughs in solid tumours. The financial report mentioned that BeOne expects over 20 R&D milestones in the next 18 months and is building a global pipeline targeting high-incidence cancers such as lung, breast and gastric tumours with highly differentiated molecules.
In the case of haematology, BeOne has two products in Phase III: BCL2 inhibitor sonrotoclax and BTK-based chimeric degradation-activating compound (CDAC) BGB 16673, both of which will soon release pivotal data and initiate new trials.
In H2 2025, sonrotoclax’s Phase II trial for r/r mantle cell lymphoma (MCL) is expected to report data, potentially leading to global accelerated approval submissions. Currently, sonrotoclax’s applications for r/r chronic lymphocytic leukaemia (CLL) and r/r MCL have been accepted in China and granted priority review.
BGB 16673 is expected to initiate a Phase III head-to-head trial against the non-covalent BTK inhibitor pirtobrutinib for r/r CLL.
Meanwhile, both drugs have multiple ongoing late-stage studies, including a global trial of sonrotoclax combined with an anti-CD20 antibody for r/r CLL, which has enrolled its first patient, and the global BGB 16673 302 trial for r/r CLL, which has also initiated enrolment.
Another highlight for BeOne in H2 is progress in its solid tumour pipeline.
According to last week’s report, BGB 58067 (a PRMT5 inhibitor) and BG 89894 (a MAT2A inhibitor) in lung cancer are expected to reach first-patient enrolment for combination therapy trials this year.
In gastrointestinal cancers, zanidatamab (a HER2-targeting bispecific antibody) is also expected to hit new milestones, with a Phase III trial for first-line HER2-positive gastroesophageal adenocarcinoma (Zymeworks Inc./Jazz Pharmaceuticals collaboration) set to report primary progression-free survival (PFS) data.
Currently, zanidatamab has been approved and commercialised for second-line HER2-high biliary tract cancer in China, undoubtedly creating a new growth driver beyond haematology for BeOne.
Notably, BeOne also stated at its recent R&D Day that eight proof-of-concept milestones in solid tumours will be achieved in the next six months, including BG T187 (an EGFR/MET trispecific antibody), BG 60366 (an EGFR CDAC), and BG C137 (an FGFR2b ADC).
In H1 2025, BeOne’s R&D expenses grew 10% YoY to approximately USD 1.0 billion. With sustained R&D investment and an efficient R&D system, BeOne’s next blockbuster is poised to emerge quickly, propelling its march toward becoming a global oncology leader.
Following the earnings release, BeOne’s US pre-market shares rose over 4%. From the start of the year to the date of publication, BeOne’s A-share price has surged 52.5% with market cap exceeding RMB 378 billion, while Hong Kong Stock Exchange (HKEX) shares rose over 67%.