On May 6, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the first quarter of 2026.
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John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:
"These strong first-quarter results reinforce BeOne’s continued growth as a global oncology leader, driven by disciplined commercial execution, and underpinned by our established hematology leadership, and an impressive, rapidly emerging solid tumor pipeline. The sustained competitive advantages of our global superhighway for clinical development and manufacturing are now clear. BRUKINSA has firmly established itself as the foundational, best-in-class BTK inhibitor with unmatched long-term efficacy and safety data for the treatment of CLL and as the only BTKi with proven efficacy superiority over ibrutinib which has resulted in clear global revenue leadership. The fixed-duration combination of sonrotoclax, a foundational, next-generation BCL2 inhibitor, and BRUKINSA represents a potential new standard-of-care in first-line CLL, with BTK CDAC BGB-16673 emerging as a potential first-in-class therapy in the relapsed or refractory setting. With more than 20 abstracts across our hematology and solid tumor pipeline accepted for presentation at ASCO (Free ASCO Whitepaper), BeOne has solidified its position as a leading oncology company."
(Amounts in thousands of U.S. dollars and unaudited)
Three Months Ended
March 31,
2026
2025
% Change
Net product revenues
$
1,487,329
$
1,108,530
34
%
Other revenue
$
26,109
$
8,749
198
%
Total revenue
$
1,513,438
$
1,117,279
35
%
GAAP income from operations
$
249,902
$
11,102
2,151
%
Adjusted income from operations*
$
414,394
$
139,357
197
%
GAAP net income
$
227,357
$
1,270
17,802
%
Adjusted net income*
$
375,042
$
136,137
175
%
GAAP basic EPS per ADS
$
2.05
$
0.01
20,400
%
Adjusted basic EPS per ADS*
$
3.38
$
1.27
166
%
GAAP diluted EPS per ADS
$
1.96
$
0.01
19,500
%
Adjusted diluted EPS per ADS*
$
3.24
$
1.22
166
%
Free Cash Flow*
$
160,547
$
(12,325
)
1,403
%
* For an explanation of our use of non-GAAP financial measures, refer to the "Note Regarding Use of Non-GAAP Financial Measures" section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.
First Quarter 2026 Financial Results
Product Revenue totaled $1.5 billion for the first quarter of 2026, representing growth of 34% compared to the prior-year period.
BRUKINSA: Global sales totaled $1.1 billion for the first quarter of 2026, representing growth of 38% compared to the prior-year period; U.S. sales of BRUKINSA totaled $761 million in the first quarter of 2026, representing growth of 35% compared to the prior-year period.
TEVIMBRA (tislelizumab): Global sales totaled $206 million in the first quarter of 2026, representing growth of 20% compared to the prior-year period.
Amgen in-licensed products: Global sales totaled $142 million in the first quarter of 2026, representing growth of 25% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the first quarter of 2026 was 89%, compared to 85% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA.
Operating Expenses
The following table summarizes operating expenses for the first quarter of 2026:
GAAP
Non-GAAP
(unaudited, in thousands, except percentages)
Q1 2026
Q1 2025
% Change
Q1 2026
Q1 2025
% Change
Research and development
$
541,224
$
481,887
12
%
$
465,904
$
421,195
11
%
Selling, general and administrative
$
555,097
$
459,288
21
%
$
471,993
$
395,511
19
%
Total operating expenses
$
1,096,321
$
941,175
16
%
$
937,897
$
816,706
15
%
Research and Development (R&D) Expenses increased for the first quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing preclinical programs into the clinic and early clinical programs into late stage.
Selling, General and Administrative (SG&A) Expenses increased for the first quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth. SG&A expenses as a percentage of product sales were 37% for the first quarter of 2026, compared to 41% in the prior-year period.
Net Income and Basic/Diluted Earnings Per Share
GAAP net income for the first quarter of 2026 was $227 million, an increase of $226 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage.
For the first quarter of 2026, basic and diluted earnings per share were $0.16 and $0.15 per share and $2.05 and $1.96 per American Depositary Share (ADS), compared to basic and diluted earnings per share of $0.00 per share and $0.01 per ADS in the prior-year period.
Free Cash Flow for the first quarter of 2026 was $161 million, representing an increase of $173 million over the prior-year period.
For further details on BeOne’s First Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the first quarter of 2026 filed with the U.S. Securities and Exchange Commission.
Updated Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
Prior FY 2026 Guidance
Current FY 2026 Guidance1
Total revenue
$6.2 – $6.4 billion
$6.3 – $6.5 billion
GAAP gross margin %
High-80% range
High-80% range
GAAP operating expenses2
(combined R&D and SG&A)
$4.7 – $4.9 billion
$4.7 – $4.9 billion
GAAP operating income2
$700 – $800 million
$750 – $850 million
Non-GAAP operating income2,3
$1.4 – $1.5 billion
$1.45 – $1.55 billion
1 Assumes May 1, 2026 foreign exchange rates.
2 Does not assume any potential new, material business development activity or unusual/non-recurring items.
3 Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth.
BeOne’s total revenue guidance for full year 2026 of $6.3 billion to $6.5 billion includes expectations for strong revenue growth driven by BRUKINSA’s leadership position in the U.S. and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage.
The Company is providing the following additional guidance on items impacting net income and earnings per ADS:
Other income (expense): Estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement.
Income tax outlook: Earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship. See Form 10-Q for additional updates on income tax uncertainties.
Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million.
First Quarter 2026 Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
Received Orphan Drug Designation in Japan for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL).
Submitted New Drug Application in Japan for R/R MZL and tablet formulation.
Sonrotoclax (BCL2 inhibitor)
Launched and commercially available in China for the treatment of adult patients with R/R mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Included in the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) guidelines as a recommended third-line treatment for R/R MCL patients.
TEVIMBRA (tislelizumab)
Received acceptance of a Supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) with Priority Review for the treatment of adult patients with first-line HER2-positive gastroesophageal adenocarcinoma (GEA) in combination with ZIIHERA (zanidatamab) and chemotherapy, based on results of the HERIZON-GEA-01 trial which demonstrated statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy.
Received acceptance of sBLA by the Center for Drug Evaluation (CDE) in China for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
ZIIHERA (zanidatamab)
Received acceptance of sBLA by the CDE in China for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
Select Clinical-Stage Programs
Hematology
BGB-16673 (BTK CDAC): Initiated Phase 2 cohorts in R/R MZL and Richter’s Transformation.
Breast and Gynecological Cancers
BGB-43395 (CDK4 inhibitor): Received acceptance of Phase 1 study data as a poster presentation at ASCO (Free ASCO Whitepaper).
BG-C9074 (B7-H4 ADC): Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO (Free ASCO Whitepaper).
Gastrointestinal Cancers
BGB-B2033 (GPC3x41BB bispecific antibody):
Received FDA Orphan Drug Designation for hepatocellular carcinoma (HCC).
Initiated potentially registrational study in patients with HCC.
Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO (Free ASCO Whitepaper).
Lung Cancer
BG-C0979 (ADAM9-targeting ADC): Initiated first-in-human study.
Inflammation and Immunology
BG-A3004 (KLRG1 mAb): Initiated first-in-human study.
Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•
Interim analysis in the Phase 3 MANGROVE study data in combination with rituximab versus bendamustine plus rituximab for the treatment of adult patients with first-line MCL.
1H 2026
•
Japan regulatory action for the treatment of adult patients with first-line gastric cancer.
1H 2026
•
U.S. FDA regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA.
2H 2026
TEVIMBRA
•
China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA.
1H 2027
Hematology
•
Sonrotoclax (BCL2 inhibitor):
◦
FDA regulatory action on New Drug Application as monotherapy treatment of adult patients with R/R MCL.
1H 2026
◦
Phase 3 study initiation for the treatment of adult patients with R/R multiple myeloma t(11;14).
2H 2026
•
BGB-16673 (BTK CDAC):
◦
Phase 2 potential accelerated approval submission (if data support) for the treatment of adult patients with R/R CLL.
2H 2026
Breast/Gynecologic
•
BGB-43395 (CDK4 inhibitor):
Cancers
◦
Phase 3 study initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.
1H 2026
Lung Cancer
•
BON-110 (PD-1xVEGF-AxCTLA-4 trispecific antibody):
First-in-human study initiation.
1H 2026
Gastrointestinal
•
BGB-B2033 (GPC3x41BB bispecific antibody):
Cancers
◦
Pivotal Phase 3 study initiation.
2H 2026
Inflammation and
•
BGB-16673 (BTK CDAC):
Immunology
Phase 2 study initiation for the treatment of adult patients with chronic spontaneous urticaria.
2H 2026
Corporate Updates
Entered into an exclusive option with Huahui Health to license worldwide rights to HH160 (BON-110), a novel trispecific antibody targeting PD-1, VEGF-A and CTLA-4.
BeOne’s Earnings Results Webcast
The Company’s earnings conference call for the first quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, May 6, 2026, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available.
(Press release, BeOne Medicines, MAY 6, 2026, View Source [SID1234665183])