BofA International released a research report highlighting BEIGENE's (06160) strong product sales in the fourth quarter of last year. Zanubrutinib sales reached $1.1 billion, representing year-on-year and quarter-on-quarter increases of 38% and 10%, respectively. Sales in the United States amounted to $845 million, rising 37% year-on-year and 14% quarter-on-quarter. Among first-line chronic lymphocytic leukemia (1L CLL) patients, Zanubrutinib captured approximately half of the BTK inhibitor market share and about a quarter of the share across all treatment classes.
The company's gross margin for the fourth quarter improved by 4.7 percentage points year-on-year to 90.5%. The general and administrative expense ratio decreased by 7.7 percentage points compared to the same period last year. Non-GAAP net profit significantly increased year-on-year to $225 million.
The company provided guidance for 2026, projecting revenues between $6.2 billion and $6.4 billion. GAAP operating expenses are expected to be in the range of $4.7 billion to $4.9 billion, with the gross margin anticipated to be at the high end of the 80% range. Non-GAAP net profit is forecasted to be between $1.4 billion and $1.5 billion. BofA International maintains its "Buy" rating on the stock.
The report indicated the company is focusing on four key areas. Firstly, in chronic lymphocytic leukemia, sotrovimab is expected to launch in Europe and the US within the year, and a BTK CDAC candidate is anticipated to submit a marketing application in the second half of 2026. A Phase III trial for the fixed-duration Zanubrutinib plus sotrovimab (ZS) regimen, the first of its mechanism, has recently been initiated. Future strategies may involve ZS targeting first-line treatment, with CDAC monotherapy and sotrovimab plus CDAC FDR focusing on relapsed/refractory populations.
Secondly, in other hematological malignancies, the company aims to expand into indications such as other lymphomas, multiple myeloma, and acute myeloid leukemia, leveraging later-stage assets like zanubrutinib and sotrovimab, as well as therapies targeting CD19/CD20, including trispecific antibodies, bispecific antibodies, and cell therapies.
Thirdly, in solid tumors, efforts are concentrated on breast cancer, lung cancer, and gastrointestinal cancers. A recent success with a PD-1 inhibitor + HER2 bispecific antibody + chemotherapy regimen in first-line HER2-positive gastric cancer could potentially expand its application overseas. Candidates including a CDK4 inhibitor, a B7H4 ADC, and a GPC3/4-1BB bispecific antibody have either entered or are expected to initiate registrational studies within the next 12 months.
Finally, in inflammation/immunology, early data for the BTK CDAC and IRAK4 CDAC candidates are expected to be read out in 2026.
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