STOCK TITAN

BeOne Medicines raises 2026 revenue outlook to $6.9B–$7B

BeOne expects certain valuation allowances to reverse in Q4 2026, potentially resulting in a material tax benefit.

Available on EDGAR Accepted by SEC EDGAR Learn about SEC filing dates
(High)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
8-K

Rhea-AI Filing Summary

BeOne Medicines Ltd. (ONC) reported third-quarter 2026 revenue of $1.89 billion, up 34% year over year, and GAAP net income of $384.7 million, up 208%. BRUKINSA global sales were $1.4 billion, up 34%; diluted earnings were $3.28 per ADS on a GAAP basis and $4.59 per ADS on an adjusted basis.

BeOne raised full-year 2026 revenue guidance to $6.9 billion to $7.0 billion, with GAAP operating income guidance of $1.2 billion to $1.3 billion and non-GAAP operating income guidance of $1.9 billion to $2.0 billion. Third-quarter free cash flow was $473.5 million, up 34% year over year.

Business updates included Japan's approval of TEVIMBRA for first-line nasopharyngeal cancer, FDA Priority Review designation for the Phase 3 MANGROVE filing, and a Phase 2 CaDAnCe-101 primary-endpoint result in relapsed/refractory CLL. BeOne also announced a clinical collaboration and a separate regional-rights agreement granting it exclusive development and commercialization rights to Revolution Medicines' assets in select Asian markets.

3 points · 1 major

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 0 points

Hollow bars mark forward-looking points. How the balance works

Positive

  • Major point. Forward-looking: it has not happened yet and may not happen.2026 revenue guidance was raised to $6.9 billion to $7.0 billion.
  • Moderate pointThird-quarter revenue reached $1.89 billion, up 34% year over year.
  • Moderate pointGAAP net income rose 208% to $384.7 million in Q3 2026.

Negative

  • None.

Filing Explained

BeOne expects a reversal of certain valuation allowances in Q4 2026 that could produce a material tax benefit, while the amount remains under evaluation.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Total revenue $1.89 billion Third quarter 2026; up 34% year over year
BRUKINSA global sales $1.4 billion Third quarter 2026; up 34% year over year
GAAP net income $384.7 million Third quarter 2026; up 208% year over year
Adjusted net income $538.7 million Third quarter 2026; up 77% year over year
GAAP diluted earnings per ADS $3.28 per ADS Third quarter 2026; up 201% year over year
Adjusted diluted earnings per ADS $4.59 per ADS Third quarter 2026; up 73% year over year
Free Cash Flow $473.5 million Third quarter 2026; up 34% year over year
Total revenue guidance $6.9 billion to $7.0 billion Current full-year 2026 guidance
Non-GAAP financial measures financial
"Non-GAAP financial measures are intended to provide additional information"
Non-GAAP financial measures are numbers companies use to show their financial performance that exclude certain expenses or income. They help investors see how the company might perform without one-time costs or other unusual items, giving a different perspective from official reports. However, since they can be adjusted, they don’t always tell the full story and should be looked at alongside standard financial figures.
Priority Review regulatory
"Received U.S. Food and Drug Administration (FDA) Priority Review designation"
Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.
Orphan Drug Designation regulatory
"Received Orphan Drug Designation from the European Commission"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
valuation allowance financial
"a valuation allowance on its net deferred tax assets"
A valuation allowance is a reserve set aside to reduce the value of certain assets on a company's financial records when there is uncertainty about whether they will generate the expected benefits. It acts like a caution sign, indicating that some assets might not be fully recoverable or worth their recorded amount. This matters to investors because it provides a more realistic picture of a company's financial health and potential risks.
overall response rate medical
"met its primary endpoint of overall response rate"
Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.
Total revenue $1.89 billion Up 34% year over year
GAAP net income $384.7 million Up 208% year over year
GAAP diluted earnings per ADS $3.28 per ADS Up 201% year over year
Adjusted diluted earnings per ADS $4.59 per ADS Up 73% year over year
Free Cash Flow $473.5 million Up 34% year over year
Guidance

Full-year 2026 total revenue of $6.9 billion to $7.0 billion; GAAP operating income of $1.2 billion to $1.3 billion; non-GAAP operating income of $1.9 billion to $2.0 billion.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is ONC's 2026 revenue and operating income guidance?

BeOne raised full-year 2026 total revenue guidance to $6.9 billion to $7.0 billion, GAAP operating income to $1.2 billion to $1.3 billion, and non-GAAP operating income to $1.9 billion to $2.0 billion. Guidance assumes November 1, 2026 foreign exchange rates and does not assume potential new material business development activity or unusual or non-recurring items.

How much did TEVIMBRA and Amgen in-licensed products sell in Q3 2026?

TEVIMBRA global sales totaled $243 million, up 28% year over year, and Amgen in-licensed products had global sales of $167 million, up 26% year over year.

When does BeOne expect a possible valuation allowance reversal?

BeOne expects the reversal of certain valuation allowances to occur in Q4 2026. The company said earnings may provide sufficient positive evidence for the reversal, which would result in a material tax benefit when recognized, and that it continues to evaluate the magnitude.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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0001651308false00016513082026-11-052026-11-05

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form 8-K
_________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): November 5, 2026

BEONE MEDICINES LTD.
(Exact Name of Registrant as Specified in Charter)
Switzerland
001-37686
98-1209416
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
c/o BeOne Medicines I GmbH
Aeschengraben 27
Basel 4051
Switzerland
(Address of Principal Executive Offices) (Zip Code)
+41 61 685 19 00
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per shareONCThe Nasdaq Global Select Market
Ordinary Shares, par value $0.0001 per share*06160The Stock Exchange of Hong Kong Limited
*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o




Item 2.02. Results of Operations and Financial Condition.
On November 5, 2026, BeOne Medicines Ltd. announced its financial results for the three months ended September 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.Description
99.1
Press release titled “BeOne Medicines Announces Third Quarter 2026 Financial Results and Business Updates” issued by BeOne Medicines Ltd. on November 5, 2026
104The cover page from this Current Report on Form 8-K, formatted in Inline XBRL
The portions of the press release set forth under Item 2.02 of this Current Report on Form 8-K are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.



Exhibit Index
 
Exhibit No.Description
99.1
Press release titled “BeOne Medicines Announces Third Quarter 2026 Financial Results and Business Updates” issued by BeOne Medicines Ltd. on November 5, 2026
104The cover page from this Current Report on Form 8-K, formatted in Inline XBRL
 



SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
BEONE MEDICINES LTD.
Date: November 5, 2026
By: /s/ Chan Lee
Name:Chan Lee
Title:Senior Vice President, General Counsel


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Exhibit 99.1
BeOne Medicines Announces Third Quarter 2026 Financial Results and Business Updates
•Total global revenues of $1.9 billion for the third quarter, an increase of 34% from the prior year
•BRUKINSA (zanubrutinib) global revenues of $1.4 billion for the third quarter, an increase of 34% from the prior year
•Diluted GAAP Earnings per American Depository Share (ADS) of $3.28 for the third quarter; non-GAAP diluted Earnings per ADS of $4.59 for the third quarter
•Raised 2026 total revenue guidance to $6.9 to $7.0 billion; GAAP operating income of $1.2 to $1.3 billion, non-GAAP operating income of $1.9 to $2.0 billion
SAN CARLOS, Calif. – November 5, 2026 – BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the third quarter of 2026.
John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:
“Our strong third quarter results and raised full-year guidance reflect continued rapid global growth and leadership in hematology, anchored by our foundational BTK inhibitor BRUKINSA, which drives powerful and sustained responses in patients, and now joined by our next-generation BCL2 inhibitor BEQALZI. We look forward to multiple catalysts in the coming months from one of the deepest pipelines in oncology, spanning hematology and solid tumors, accelerated by our differentiated capabilities in R&D, manufacturing, and commercialization.”
(Amounts in thousands of U.S. dollars and unaudited)
Three Months EndedNine Months Ended
September 30,September 30,
20262025% Change20262025% Change
Net product revenues$1,855,057 $1,395,013 33 %$5,022,180 $3,805,619 32 %
Other revenue$34,758 $17,271 101 %$86,144 $39,244 120 %
Total revenue$1,889,815 $1,412,284 34 %$5,108,324 $3,844,863 33 %
GAAP income from operations$418,675 $163,114 157 %$993,624 $262,101 279 %
Adjusted income from operations*$612,226 $341,184 79 %$1,529,649 $755,486 102 %
GAAP net income$384,706 $124,841 208 %$849,070 $220,431 285 %
Adjusted net income*$538,735 $303,663 77 %$1,358,274 $692,622 96 %
GAAP basic EPS per ADS$3.38 $1.13 199 %$7.58 $2.03 273 %
Adjusted basic EPS per ADS*$4.74 $2.76 72 %$12.12 $6.38 90 %
GAAP diluted EPS per ADS$3.28 $1.09 201 %$7.30 $1.96 272 %
Adjusted diluted EPS per ADS*$4.59 $2.65 73 %$11.68 $6.14 90 %
Free Cash Flow*$473,532 $354,469 34 %$1,069,423 $561,916 90 %
* 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.


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Exhibit 99.1
Third Quarter 2026 Financial Results
Product Revenue totaled $1.9 billion for the third quarter of 2026, representing growth of 33% compared to the prior-year period.
•BRUKINSA: Global sales totaled $1.4 billion for the third quarter of 2026, representing growth of 34% compared to the prior-year period; U.S. sales of BRUKINSA totaled $1.0 billion in the third quarter of 2026, representing growth of 36% compared to the prior-year period.
•TEVIMBRA (tislelizumab): Global sales totaled $243 million in the third quarter of 2026, representing growth of 28% compared to the prior-year period.
•Amgen in-licensed products: Global sales totaled $167 million in the third quarter of 2026, representing growth of 26% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the third quarter of 2026 was 88%, compared to 86% 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 the Company’s portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA, which was offset by a non-cash intangible asset impairment charge of $22 million associated with our decision to discontinue promotion of POBEVCY. On an adjusted basis, which does not include depreciation and amortization, or the impairment charge, gross margin as a percentage of product sales increased to 90%, from 86% in the comparable period of the prior year.
Operating Expenses
The following table summarizes operating expenses for the third quarter of 2026:
GAAPNon-GAAP
(unaudited, in thousands, except percentages)Q3 2026Q3 2025% ChangeQ3 2026Q3 2025% Change
Research and development $660,784 $523,662 26 %$586,168 $445,904 31 %
Selling, general and administrative $593,460 $528,998 12 %$503,719 $434,484 16 %
Total operating expenses$1,254,244 $1,052,660 19 %$1,089,887 $880,388 24 %
The following table summarizes operating expenses for the year-to-date period ended September 30, 2026, and 2025:
GAAPNon-GAAP
(unaudited, in thousands, except percentages)Q3 YTD 2026Q3 YTD 2025% ChangeQ3 YTD 2026Q3 YTD 2025% Change
Research and development $1,814,288 $1,530,445 19 %$1,586,022 $1,311,156 21 %
Selling, general and administrative $1,741,771 $1,526,199 14 %$1,476,386 $1,271,650 16 %
Total operating expenses$3,556,059 $3,056,644 16 %$3,062,408 $2,582,806 19 %
Research and Development (R&D) Expenses increased for the third quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing early clinical programs into late stage and preclinical programs into the clinic.
Selling, General and Administrative (SG&A) Expenses increased for the third quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth.
Net Income and Basic/Diluted Earnings Per Share
GAAP net income for the third quarter of 2026 was $385 million, an increase of $260 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage. Adjusted net income was $539 million, an increase of $235 million over the prior-year period.


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Exhibit 99.1
For the third quarter of 2026, basic and diluted earnings per share were $0.26 and $0.25 per share and $3.38 and $3.28 per American Depositary Share (ADS), respectively, compared to $0.09 and $0.08 per share and $1.13 and $1.09 per ADS in the prior-year period. On an adjusted basis, basic and diluted earnings per share was $0.36 and $0.35 per share and $4.74 and $4.59 per ADS, respectively, compared to $0.21 and $0.20 per share and $2.76 and $2.65 per ADS in the prior-year period.
Free Cash Flow for the third quarter of 2026 was $474 million, representing an increase of $119 million over the prior-year period.
For further details on BeOne’s Third Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the third quarter of 2026 filed with the U.S. Securities and Exchange Commission.
Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
Prior FY 2026 Guidance
Current FY 2026 Guidance1
Total revenue$6.6B - $6.8B$6.9B - $7.0B
GAAP gross margin %High-80% rangeHigh-80% range
GAAP operating expenses2
(combined R&D and SG&A)
$4.8B - $5.0B$4.9B - $5.0B
GAAP operating income2
$1.0B - $1.1B$1.2B - $1.3B
Non-GAAP operating income2,3
$1.7B - $1.8B$1.9B - $2.0B
1 Assumes November 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 $6.9 billion to $7.0 billion reflects performance through the third quarter and the Company’s expectations for the remainder of the year. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth.
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 the 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 Company continues to evaluate and assess the magnitude but expects the reversal will occur in the fourth quarter of 2026. See Form 10-Q for additional updates.
•Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million.
Third Quarter 2026 Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Received U.S. Food and Drug Administration (FDA) Priority Review designation for the Phase 3 MANGROVE filing.
•Completed Phase 3 MANGROVE regulatory submissions in the EU and China.
•29 abstracts accepted for presentation at the American Society of Hematology (ASH) 2026 Annual Meeting, including interim analysis results from the Phase 3 MANGROVE study in first-line mantle cell lymphoma (MCL) to be presented during the Plenary Scientific Session.

BEQALZI (sonrotoclax)
•10 abstracts accepted for presentation at ASH 2026.
TEVIMBRA (tislelizumab)
•Received Japan regulatory approval for the treatment of adult patients with first-line nasopharyngeal cancer.


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Exhibit 99.1
ZIIHERA (zanidatamab) for which BeOne holds commercialization rights in select markets
•Presented Phase 3 survival data reinforcing benefit of ZIIHERA-containing regimens in first-line HER2+ gastroesophageal adenocarcinoma (GEA) at the European Society for Medical Oncology Congress 2026 (ESMO 2026).
•Received U.S. Food and Drug Administration (FDA) approval for TEVIMBRA-based regimen for first-line HER2+ GEA.

Select Clinical-Stage Programs
Hematology
•6 Tacabrutideg abstracts accepted for presentation at ASH 2026.
•Tacabrutideg (BTK CDAC): Pivotal Phase 2 portion of CaDAnCe-101 met its primary endpoint of overall response rate in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
•BG-75202 (KAT6 A/B inhibitor): First patient enrolled into monotherapy cohort for the Phase 1 study for the treatment of adult patients with acute myeloid leukemia.
Gastrointestinal Cancers
•BGB-B2033 (GPC3x4-1BB bispecific antibody):
◦Updated data presented at ESMO 2026.
◦Received Orphan Drug Designation from the European Commission and awarded Innovation Passport, enabling entry to the UK's Innovative Licensing and Access Pathway, in hepatocellular carcinoma (HCC).
•BG-85738 (RAS ONi): First patient enrolled in the Phase 1 study of advanced solid tumors with RAS mutations.
Lung Cancer
•BG-C477 (CEA ADC):
◦Disclosed first clinical data at ESMO 2026.
◦Received FDA Fast Track Designation for the treatment of patients with advanced or metastatic CEA-high non-small cell lung cancer whose disease has progressed following prior systemic therapy.
•BGB 58067 (MTA-cooperative PRMT5 inhibitor): Disclosed first clinical data at ESMO 2026.

Breast and Gynecological Cancers
•BG-C9074 (B7-H4 ADC): Initiated Starstone-301 Phase 3 study in combination with bevacizumab for the treatment of adult patients with first-line ovarian cancer in maintenance setting.

Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Regulatory submission in Japan for the treatment of adult patients with first-line MCL.
Q4 2026
TEVIMBRA
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
1H 2027
ZIIHERA
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
1H 2027
Tacabrutideg(BGB-16673)
•Phase 2 potential submission for the treatment of adult patients with R/R CLL.
Mid 2027
•CaDAnCe-306: Phase 3 study initiation for R/R CLL in combination with BEQALZI
1H 2027
BGB-B2033
(GPC3x4-1BB bispecific antibody)
•GroundBBreaker-301 Phase 3 study initiation in second-line or later hepatocellular carcinoma.
Q4 2026
•GroundBBreaker-201 potentially pivotal single-arm Phase 2 study initiation in second-line or later hepatocellular carcinoma.
Q4 2026
•GroundBBreaker-302 pivotal Phase 3 study initiation in first-line hepatocellular carcinoma
1H 2027


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Exhibit 99.1
Corporate Updates
•Announced a multi-part collaboration with Revolution Medicines, including a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines’ four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets.
•Announced a voluntary agreement with the U.S. Government to expand access to innovative cancer medicines for American patients while strengthening the Company’s U.S manufacturing footprint.
•Announced the renewal of a partnership with the BeOne Care Foundation and The Max Foundation, a leading global health nonprofit organization, to expand access to BRUKINSA for the treatment of adult patients with CLL in low- and middle-income countries through 2028.
BeOne’s Earnings Results Webcast
The Company’s earnings conference call for the third quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Thursday, November 5, 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.
About BeOne
BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before.
To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding: BeOne’s continued rapid global growth and leadership in hematology; future catalysts for BeOne’s business; BeOne’s full year 2026 guidance; BeOne’s expectations regarding certain valuation allowances; BeOne’s expectations regarding continued global expansion and investment to support growth; upcoming R&D milestones to be achieved by BeOne; the timing of clinical and regulatory developments and data readouts; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.


Investor ContactMedia Contact
Liza HeapesMeredith Ferguson
+1 857-302-5663+1 216-338-3797
ir@beonemed.commedia@beonemed.com



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Exhibit 99.1
Condensed Consolidated Statements of Operations (U.S. GAAP)
(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2026202520262025
(Unaudited)(Unaudited)
Revenues
Product revenue, net$1,855,057 $1,395,013 $5,022,180 $3,805,619 
Other revenue34,758 17,271 86,144 39,244 
Total revenues1,889,815 1,412,284 5,108,324 3,844,863 
Cost of sales - products216,896 196,510 558,641 526,118 
Gross profit1,672,919 1,215,774 4,549,683 3,318,745 
Operating expenses:
Research and development660,784 523,662 1,814,288 1,530,445 
Selling, general and administrative 593,460 528,998 1,741,771 1,526,199 
Total operating expenses1,254,244 1,052,660 3,556,059 3,056,644 
Income from operations418,675 163,114 993,624 262,101 
Interest income33,663 19,393 89,227 43,735 
Interest expense(42,407)(16,364)(115,033)(31,361)
Other income (expense), net429 (18,979)14,216 (6,862)
Income before income taxes410,360 147,164 982,034 267,613 
Income tax expense25,654 22,323 132,964 47,182 
Net income$384,706 $124,841 $849,070 $220,431 
Earnings per share
Basic$0.26 $0.09 $0.58 $0.16 
Diluted$0.25 $0.08 $0.56 $0.15 
Weighted-average shares outstanding—basic1,478,074,394 1,432,801,699 1,457,134,424 1,410,497,062 
Weighted-average shares outstanding—diluted1,524,954,790 1,488,750,354 1,511,972,953 1,465,535,004 
Earnings per American Depositary Share (“ADS”)
Basic$3.38 $1.13 $7.58 $2.03 
Diluted$3.28 $1.09 $7.30 $1.96 
Weighted-average ADSs outstanding—basic113,698,030 110,215,515 112,087,263 108,499,774 
Weighted-average ADSs outstanding—diluted117,304,215 114,519,258 116,305,612 112,733,462 



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Exhibit 99.1
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
As of
September 30,December 31, 
20262025
(unaudited)(audited)
Assets:
Cash, cash equivalents and restricted cash$5,866,314 $4,609,647 
Accounts receivable, net1,092,535 865,080 
Inventories807,922 608,227 
Property, plant and equipment, net1,647,231 1,641,678 
Total assets$9,875,925 $8,188,573 
Liabilities and equity:
Accounts payable$496,879 $479,035 
Accrued expenses and other payables1,342,646 1,109,120 
R&D cost share liability— 64,345 
Sale of future royalty liability912,581 906,956 
Debt1,074,081 1,019,206 
Total liabilities4,055,531 3,827,379 
Total equity$5,820,394 $4,361,194 




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Exhibit 99.1
Select Condensed Consolidated Statements of Cash Flows (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2026202520262025
(unaudited)(unaudited)
Cash, cash equivalents and restricted cash at beginning of period$5,280,674 $2,786,086 $4,609,647 $2,638,747 
Net cash provided by operating activities508,707 402,553 1,172,863 710,233 
Net cash used in investing activities(35,760)(49,274)(130,623)(237,820)
Net cash provided by financing activities102,194 961,272 164,772 962,520 
Net effect of foreign exchange rate changes10,499 9,905 49,655 36,862 
Net increase in cash, cash equivalents, and restricted cash585,640 1,324,456 1,256,667 1,471,795 
Cash, cash equivalents and restricted cash at end of period$5,866,314 $4,110,542 $5,866,314 $4,110,542 



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Exhibit 99.1
Note Regarding Use of Non-GAAP Financial Measures
BeOne provides certain non-GAAP financial measures, including Adjusted Cost of Sales- Product, Adjusted Operating Expenses, Adjusted Income from Operations, Adjusted Income Tax Expense, Adjusted Net Income, Adjusted Earnings Per Share, Free Cash Flow and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeOne’s operating performance. Adjustments to BeOne’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Non-GAAP adjustments are tax effected to the extent there is U.S. GAAP current tax expense. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects. BeOne maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeOne believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeOne’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of BeOne’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeOne’s management uses for planning and forecasting purposes and measuring BeOne’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by BeOne may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.


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Exhibit 99.1
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES
(Amounts in thousands of U.S. Dollars, except for per share and per ADS data)
(unaudited)

Three Months Ended Nine Months Ended
September 30,September 30,
2026202520262025
Reconciliation of GAAP to adjusted cost of sales - products:
GAAP cost of sales - products$216,896 $196,510 $558,641 $526,118 
Less: Depreciation5,596 4,261 15,442 10,195 
Less: Amortization of intangibles23,598 1,537 26,932 8,459 
Less: Other— — — 893 
Adjusted cost of sales - products$187,702 $190,712 $516,267 $506,571 
Reconciliation of GAAP to adjusted research and development:
GAAP research and development$660,784 $523,662 $1,814,288 $1,530,445 
Less: Share-based compensation cost56,474 58,839 168,866 164,998 
Less: Depreciation18,142 18,919 59,400 54,291 
Adjusted research and development$586,168 $445,904 $1,586,022 $1,311,156 
Reconciliation of GAAP to adjusted selling, general and administrative:
GAAP selling, general and administrative$593,460 $528,998 $1,741,771 $1,526,199 
Less: Share-based compensation cost76,143 81,947 224,566 221,792 
Less: Depreciation13,582 12,550 40,769 32,712 
Less: Amortization of intangibles16 17 50 45 
Adjusted selling, general and administrative$503,719 $434,484 $1,476,386 $1,271,650 
Reconciliation of GAAP to adjusted operating expenses:
GAAP operating expenses $1,254,244 $1,052,660 $3,556,059 $3,056,644 
Less: Share-based compensation cost132,617 140,786 393,432 386,790 
Less: Depreciation 31,724 31,469 100,169 87,003 
Less: Amortization of intangibles16 17 50 45 
Adjusted operating expenses$1,089,887 $880,388 $3,062,408 $2,582,806 
Reconciliation of GAAP to adjusted income from operations:
GAAP income from operations$418,675 $163,114 $993,624 $262,101 
Plus: Share-based compensation cost132,617 140,786 393,432 386,790 
Plus: Depreciation37,320 35,730 115,611 97,198 
Plus: Amortization of intangibles23,614 1,554 26,982 8,504 
Plus: Other— — — 893 
Adjusted income from operations$612,226 $341,184 $1,529,649 $755,486 
Reconciliation of GAAP to adjusted income tax expense:
GAAP income tax expense$25,654 $22,323 $132,964 $47,182 
Plus: Discrete tax items11,527 926 (41,847)9,663 
Plus: Income tax effect of non-GAAP adjustments27,995 17,044 68,668 45,747 
Adjusted income tax expense$65,176 $40,293 $159,785 $102,592 


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Exhibit 99.1
Three Months Ended Nine Months Ended
September 30,September 30,
2026202520262025
Reconciliation of GAAP to adjusted net income:
GAAP net income$384,706 $124,841 $849,070 $220,431 
Plus: Share-based compensation expenses132,617 140,786 393,432 386,790 
Plus: Depreciation37,320 35,730 115,611 97,198 
Plus: Amortization of intangibles23,614 1,554 26,982 8,504 
Plus: Other— — — 893 
Plus: Impairment of equity investments— 18,722 — 34,216 
Plus: Discrete tax items(11,527)(926)41,847 (9,663)
Plus: Income tax effect of non-GAAP adjustments1
(27,995)(17,044)(68,668)(45,747)
Adjusted net income$538,735 $303,663 $1,358,274 $692,622 
Reconciliation of GAAP to adjusted EPS - basic
GAAP earnings per share - basic$0.26 $0.09 $0.58 $0.16 
Plus: Share-based compensation expenses0.09 0.10 0.27 0.27 
Plus: Depreciation0.03 0.02 0.08 0.07 
Plus: Amortization of intangibles0.02 0.00 0.02 0.01 
Plus: Other0.00 0.00 0.00 0.00 
Plus: Impairment of equity investments0.00 0.01 0.00 0.02 
Plus: Discrete tax items(0.01)0.00 0.03 (0.01)
Plus: Income tax effect of non-GAAP adjustments1
(0.02)(0.01)(0.05)(0.03)
Adjusted earnings per share - basic$0.36 $0.21 $0.93 $0.49 
Reconciliation of GAAP to adjusted EPS - diluted
GAAP earnings per share - diluted$0.25 $0.08 $0.56 $0.15 
Plus: Share-based compensation expenses0.09 0.09 0.26 0.26 
Plus: Depreciation0.02 0.02 0.08 0.07 
Plus: Amortization of intangibles0.02 0.00 0.02 0.01 
Plus: Other0.00 0.00 0.00 0.00 
Plus: Impairment of equity investments0.00 0.01 0.00 0.02 
Plus: Discrete tax items(0.01)0.00 0.03 (0.01)
Plus: Income tax effect of non-GAAP adjustments1
(0.02)(0.01)(0.05)(0.03)
Adjusted earnings per share - diluted$0.35 $0.20 $0.90 $0.47 
Reconciliation of GAAP to adjusted earnings per ADS - basic
GAAP earnings per ADS - basic$3.38 $1.13 $7.58 $2.03 
Plus: Share-based compensation expenses1.17 1.28 3.51 3.56 
Plus: Depreciation0.33 0.32 1.03 0.90 
Plus: Amortization of intangibles0.21 0.01 0.24 0.08 
Plus: Other0.00 0.00 0.00 0.01 
Plus: Impairment of equity investments0.00 0.17 0.00 0.32 
Plus: Discrete tax items(0.10)(0.01)0.37 (0.09)
Plus: Income tax effect of non-GAAP adjustments1
(0.25)(0.15)(0.61)(0.42)
Adjusted earnings per ADS - basic$4.74 $2.76 $12.12 $6.38 


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Exhibit 99.1
Three Months Ended Nine Months Ended
September 30,September 30,
2026202520262025
Reconciliation of GAAP to adjusted earnings per ADS - diluted
GAAP earnings per ADS - diluted$3.28 $1.09 $7.30 $1.96 
Plus: Share-based compensation expenses1.13 1.23 3.38 3.43 
Plus: Depreciation0.32 0.31 0.99 0.86 
Plus: Amortization of intangibles0.20 0.01 0.23 0.08 
Plus: Other0.00 0.00 0.00 0.01 
Plus: Impairment of equity investments0.00 0.16 0.00 0.30 
Plus: Discrete tax items(0.10)(0.01)0.36 (0.09)
Plus: Income tax effect of non-GAAP adjustments1
(0.24)(0.15)(0.59)(0.41)
Adjusted earnings per ADS - diluted$4.59 $2.65 $11.68 $6.14 
1.Tax effect of Non-GAAP adjustments is based on the statutory tax rate in the relevant tax jurisdiction. Please note that the Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects.
Three Months Ended Nine Months Ended
September 30,September 30,
2026202520262025
 Free Cash Flow (Non-GAAP):
Net cash provided by operating activities (GAAP)$508,707 $402,553 $1,172,863 $710,233 
Less: Purchases of property, plant and equipment(35,175)(48,084)(103,440)(148,317)
Free Cash Flow (Non-GAAP)$473,532 $354,469 $1,069,423 $561,916 

Reconciliation of GAAP Operating Income Guidance to Non-GAAP
Operating Income Guidance for Full Year 2026
(Unaudited)
GAAP operating income1,200,000 — 1,300,000 
Plus: Adjustments to arrive at Non-GAAP1
700,000 — 700,000 
Non-GAAP operating income1,900,000 — 2,000,000 
1.The non-GAAP adjustments are based on actual results through the first nine months of 2026 and best available information at this time related to similar items for the remainder of the year.

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