BeOne Medicines Q3 Earnings Call Highlights

Key Points

• BeOne raised its 2026 revenue forecast to $6.9 billion–$7 billion and increased its operating-income outlook by $200 million across GAAP and non-GAAP ranges. Third-quarter revenue climbed to $1.9 billion, while net income reached $385 million.
• BRUKINSA sales rose 34% globally to about $1.4 billion, topping $1 billion in U.S. sales for the first time. TEVIMBRA revenue grew 28%, and product revenue also increased in China, Europe, and other markets.
• The FDA requested more safety and durability follow-up data before BeOne submits tacabrutideg for potential accelerated U.S. approval, now planned for mid-2027. The company is expanding its phase III trial to 600 patients and advancing several other cancer-drug programs.

BeOne Medicines NASDAQ: ONC raised its 2026 revenue and operating income forecasts after third-quarter sales of its cancer drug BRUKINSA topped $1 billion in the United States for the first time.

The company reported total revenue of $1.9 billion, up from $1.4 billion a year earlier, and net income of $385 million. BRUKINSA generated approximately $1.4 billion in global sales, an increase of 34%, while U.S. sales rose 36%. Chief Financial Officer Aaron Rosenberg said U.S. sales included an approximately $50 million benefit from order timing, including an extra shipping day.

BeOne also outlined plans to seek accelerated U.S. approval for its experimental blood cancer treatment tacabrutideg in mid-2027, after the Food and Drug Administration requested additional follow-up data.

Higher guidance and continued investment

BeOne now expects 2026 total revenue of $6.9 billion to $7 billion, up from its prior forecast of $6.6 billion to $6.8 billion. It raised its outlook for both GAAP and non-GAAP operating income by $200 million across their respective ranges.

• GAAP operating income: $1.2 billion to $1.3 billion.
• Non-GAAP operating income: $1.9 billion to $2 billion.
• Operating expenses: $4.9 billion to $5 billion, narrowed from $4.8 billion to $5 billion.
• Gross margin: Unchanged, in the high 80% range.

Third-quarter GAAP operating income increased 157% to $419 million, while diluted earnings per American depositary share rose to $3.28 from $1.09. Adjusted diluted earnings per ADS were $4.59, compared with $2.65 a year earlier. Free cash flow increased 34% to $474 million.

Rosenberg said the company expects 2027 operating expenses to grow at least in line with the pace of the past several years as it advances its pipeline. While operating income is expected to grow meaningfully, he said profit-margin expansion would likely be more modest than in 2025 and 2026.

BeOne also expects to reverse a portion of its deferred tax asset valuation allowance in the fourth quarter. Rosenberg said the company is still assessing the magnitude but expects a material tax benefit to its full-year GAAP net income.

Drug sales grow across regions

Beyond BRUKINSA, TEVIMBRA generated approximately $243 million in quarterly revenue, up 28% year over year, while the company’s licensed Amgen portfolio produced approximately $167 million, up 26%.

China product revenue rose 21% to approximately $527 million, including a 7% contribution to reported growth from foreign exchange. European product revenue increased 41% to approximately $234 million, while revenue from the rest of the world rose 58% to approximately $80 million.

Rosenberg cautioned that biosimilar competition for XGEVA, along with potential volume-based procurement inclusion for XGEVA and KYPROLIS, would likely pressure revenue for those brands beyond 2026. He said the recently launched BEQALZI was not expected to be a meaningful revenue driver this year because of the size of its approved indication and the timing of the launch.

Tacabrutideg filing and trial changes

BeOne said the phase II portion of its CaDAnCe-101 study of tacabrutideg in relapsed or refractory chronic lymphocytic leukemia met its primary objective response rate endpoint. Amit Agarwal, chief medical officer for hematology, said the FDA had requested additional follow-up related to safety and durability before a potential accelerated approval submission.

“We remain confident in what the dataset shows and the unmet need in that particular population,” Agarwal said, adding that the company would continue engaging with the regulator.

BeOne is increasing enrollment in its phase III CaDAnCe-304 trial, which compares tacabrutideg with pirtobrutinib, to 600 patients from 500 in an effort to accelerate an interim readout. The company expects enrollment to be completed in early 2027. It is also converting CaDAnCe-302 to a phase II study and plans to begin enrolling a phase III trial of tacabrutideg combined with sonrotoclax in the first half of 2027.

Solid tumor programs advance

President and Global Head of Research and Development Lai Wang highlighted data recently presented at the European Society for Medical Oncology meeting. In heavily pretreated liver cancer patients, the company’s GPC3 x 4-1BB bispecific antibody BGB-B2033 showed a 36% confirmed response rate. Among 27 confirmed responders, approximately 79% maintained their responses for at least six months, Wang said.

BeOne plans to start a single-arm study and a confirmatory phase III trial in previously treated liver cancer before year-end. It also plans a global phase III study of the drug in a first-line combination in the first half of 2027.

For its experimental PRMT5 inhibitor BGB-58067, BeOne reported a 38.5% confirmed response rate and median progression-free survival of 8.1 months in previously treated patients with MTAP-deficient, EGFR wild-type non-small cell lung cancer. Its CEA antibody-drug conjugate BG-C477 showed a 60% confirmed response rate in an initial phase I-A dataset of heavily pretreated lung cancer patients, Wang said. A global phase III study in second-line lung cancer is being planned.

Separately, BeOne is increasing the size of its phase III KANDELA-302 breast cancer study of a CDK4 inhibitor to approximately 1,200 patients to bring forward the readout. Mark Lanasa, chief medical officer for solid tumors, said the company believes it can enroll the larger study within the originally projected timeframe.

About BeOne Medicines (NASDAQ:ONC)

BeOne Medicines Ltd. is a global oncology company focused on discovering, developing, manufacturing and commercializing medicines for cancer patients. Formerly known as BeiGene, the company operates an integrated biotechnology platform spanning research, clinical development, regulatory activities and commercial operations.

Its portfolio includes BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor used in the treatment of several blood cancers, and TEVIMBRA (tislelizumab), an anti-PD-1 immunotherapy approved in multiple markets for certain cancers.

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