BeOne Medicines Ltd 8-K, filed Nov 5, 2026
BeOne Medicines Ltd. (ONC)
8-K
2026-11-05
For: 2026-11-05
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Added on
November 05, 2026
About this 8-K
BeOne Medicines Ltd filed this 8-K on November 5, 2026.
BeOne Medicines Ltd. reported third-quarter total global revenues of $1.9 billion, up 34% from the prior year, and BRUKINSA (zanubrutinib) revenues of $1.4 billion, up 34%. It raised 2026 total revenue guidance to $6.9 to $7.0 billion. AI summary
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
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
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) | ||||||
(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:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
| Ordinary Shares, par value $0.0001 per share* | 06160 | The 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 | |||||||
| 104 | The 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 | ||||||||
| 104 | The 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: | By: | /s/ Chan Lee | ||||||
| Name: | Chan Lee | |||||||
| Title: | Senior Vice President, General Counsel | |||||||
 | 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 Ended | Nine Months Ended | |||||||||||||||||||||||||||||||||||||
| September 30, | September 30, | |||||||||||||||||||||||||||||||||||||
| 2026 | 2025 | % Change | 2026 | 2025 | % 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.
| 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:
| GAAP | Non-GAAP | |||||||||||||||||||||||||||||||||||||
| (unaudited, in thousands, except percentages) | Q3 2026 | Q3 2025 | % Change | Q3 2026 | Q3 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:
| GAAP | Non-GAAP | |||||||||||||||||||||||||||||||||||||
| (unaudited, in thousands, except percentages) | Q3 YTD 2026 | Q3 YTD 2025 | % Change | Q3 YTD 2026 | Q3 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.
| 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% range | High-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.
| 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 | |||||||
| 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 Contact | Media Contact | |||||||
| Liza Heapes | Meredith Ferguson | |||||||
| +1 857-302-5663 | +1 216-338-3797 | |||||||
| ir@beonemed.com | media@beonemed.com | |||||||
| 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, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||||||||||||
| Revenues | ||||||||||||||||||||||||||
| Product revenue, net | $ | 1,855,057 | $ | 1,395,013 | $ | 5,022,180 | $ | 3,805,619 | ||||||||||||||||||
| Other revenue | 34,758 | 17,271 | 86,144 | 39,244 | ||||||||||||||||||||||
| Total revenues | 1,889,815 | 1,412,284 | 5,108,324 | 3,844,863 | ||||||||||||||||||||||
| Cost of sales - products | 216,896 | 196,510 | 558,641 | 526,118 | ||||||||||||||||||||||
| Gross profit | 1,672,919 | 1,215,774 | 4,549,683 | 3,318,745 | ||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||
| Research and development | 660,784 | 523,662 | 1,814,288 | 1,530,445 | ||||||||||||||||||||||
| Selling, general and administrative | 593,460 | 528,998 | 1,741,771 | 1,526,199 | ||||||||||||||||||||||
| Total operating expenses | 1,254,244 | 1,052,660 | 3,556,059 | 3,056,644 | ||||||||||||||||||||||
| Income from operations | 418,675 | 163,114 | 993,624 | 262,101 | ||||||||||||||||||||||
| Interest income | 33,663 | 19,393 | 89,227 | 43,735 | ||||||||||||||||||||||
| Interest expense | (42,407) | (16,364) | (115,033) | (31,361) | ||||||||||||||||||||||
| Other income (expense), net | 429 | (18,979) | 14,216 | (6,862) | ||||||||||||||||||||||
| Income before income taxes | 410,360 | 147,164 | 982,034 | 267,613 | ||||||||||||||||||||||
| Income tax expense | 25,654 | 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—basic | 1,478,074,394 | 1,432,801,699 | 1,457,134,424 | 1,410,497,062 | ||||||||||||||||||||||
| Weighted-average shares outstanding—diluted | 1,524,954,790 | 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—basic | 113,698,030 | 110,215,515 | 112,087,263 | 108,499,774 | ||||||||||||||||||||||
| Weighted-average ADSs outstanding—diluted | 117,304,215 | 114,519,258 | 116,305,612 | 112,733,462 | ||||||||||||||||||||||
| 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, | |||||||||||||
| 2026 | 2025 | |||||||||||||
| (unaudited) | (audited) | |||||||||||||
| Assets: | ||||||||||||||
| Cash, cash equivalents and restricted cash | $ | 5,866,314 | $ | 4,609,647 | ||||||||||
| Accounts receivable, net | 1,092,535 | 865,080 | ||||||||||||
| Inventories | 807,922 | 608,227 | ||||||||||||
| Property, plant and equipment, net | 1,647,231 | 1,641,678 | ||||||||||||
| Total assets | $ | 9,875,925 | $ | 8,188,573 | ||||||||||
| Liabilities and equity: | ||||||||||||||
| Accounts payable | $ | 496,879 | $ | 479,035 | ||||||||||
| Accrued expenses and other payables | 1,342,646 | 1,109,120 | ||||||||||||
| R&D cost share liability | — | 64,345 | ||||||||||||
| Sale of future royalty liability | 912,581 | 906,956 | ||||||||||||
| Debt | 1,074,081 | 1,019,206 | ||||||||||||
| Total liabilities | 4,055,531 | 3,827,379 | ||||||||||||
| Total equity | $ | 5,820,394 | $ | 4,361,194 | ||||||||||
| 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, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| (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 activities | 508,707 | 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 activities | 102,194 | 961,272 | 164,772 | 962,520 | ||||||||||||||||||||||
| Net effect of foreign exchange rate changes | 10,499 | 9,905 | 49,655 | 36,862 | ||||||||||||||||||||||
| Net increase in cash, cash equivalents, and restricted cash | 585,640 | 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 | ||||||||||||||||||
| 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.
| 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, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Reconciliation of GAAP to adjusted cost of sales - products: | ||||||||||||||||||||||||||
| GAAP cost of sales - products | $ | 216,896 | $ | 196,510 | $ | 558,641 | $ | 526,118 | ||||||||||||||||||
| Less: Depreciation | 5,596 | 4,261 | 15,442 | 10,195 | ||||||||||||||||||||||
| Less: Amortization of intangibles | 23,598 | 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 cost | 56,474 | 58,839 | 168,866 | 164,998 | ||||||||||||||||||||||
| Less: Depreciation | 18,142 | 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 cost | 76,143 | 81,947 | 224,566 | 221,792 | ||||||||||||||||||||||
| Less: Depreciation | 13,582 | 12,550 | 40,769 | 32,712 | ||||||||||||||||||||||
| Less: Amortization of intangibles | 16 | 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 cost | 132,617 | 140,786 | 393,432 | 386,790 | ||||||||||||||||||||||
| Less: Depreciation | 31,724 | 31,469 | 100,169 | 87,003 | ||||||||||||||||||||||
| Less: Amortization of intangibles | 16 | 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 cost | 132,617 | 140,786 | 393,432 | 386,790 | ||||||||||||||||||||||
| Plus: Depreciation | 37,320 | 35,730 | 115,611 | 97,198 | ||||||||||||||||||||||
| Plus: Amortization of intangibles | 23,614 | 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 items | 11,527 | 926 | (41,847) | 9,663 | ||||||||||||||||||||||
| Plus: Income tax effect of non-GAAP adjustments | 27,995 | 17,044 | 68,668 | 45,747 | ||||||||||||||||||||||
| Adjusted income tax expense | $ | 65,176 | $ | 40,293 | $ | 159,785 | $ | 102,592 | ||||||||||||||||||
| Exhibit 99.1 | |||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
| September 30, | September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Reconciliation of GAAP to adjusted net income: | ||||||||||||||||||||||||||
| GAAP net income | $ | 384,706 | $ | 124,841 | $ | 849,070 | $ | 220,431 | ||||||||||||||||||
| Plus: Share-based compensation expenses | 132,617 | 140,786 | 393,432 | 386,790 | ||||||||||||||||||||||
| Plus: Depreciation | 37,320 | 35,730 | 115,611 | 97,198 | ||||||||||||||||||||||
| Plus: Amortization of intangibles | 23,614 | 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 expenses | 0.09 | 0.10 | 0.27 | 0.27 | ||||||||||||||||||||||
| Plus: Depreciation | 0.03 | 0.02 | 0.08 | 0.07 | ||||||||||||||||||||||
| Plus: Amortization of intangibles | 0.02 | 0.00 | 0.02 | 0.01 | ||||||||||||||||||||||
| Plus: Other | 0.00 | 0.00 | 0.00 | 0.00 | ||||||||||||||||||||||
| Plus: Impairment of equity investments | 0.00 | 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 expenses | 0.09 | 0.09 | 0.26 | 0.26 | ||||||||||||||||||||||
| Plus: Depreciation | 0.02 | 0.02 | 0.08 | 0.07 | ||||||||||||||||||||||
| Plus: Amortization of intangibles | 0.02 | 0.00 | 0.02 | 0.01 | ||||||||||||||||||||||
| Plus: Other | 0.00 | 0.00 | 0.00 | 0.00 | ||||||||||||||||||||||
| Plus: Impairment of equity investments | 0.00 | 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 expenses | 1.17 | 1.28 | 3.51 | 3.56 | ||||||||||||||||||||||
| Plus: Depreciation | 0.33 | 0.32 | 1.03 | 0.90 | ||||||||||||||||||||||
| Plus: Amortization of intangibles | 0.21 | 0.01 | 0.24 | 0.08 | ||||||||||||||||||||||
| Plus: Other | 0.00 | 0.00 | 0.00 | 0.01 | ||||||||||||||||||||||
| Plus: Impairment of equity investments | 0.00 | 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 | ||||||||||||||||||
| Exhibit 99.1 | |||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
| September 30, | September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| 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 expenses | 1.13 | 1.23 | 3.38 | 3.43 | ||||||||||||||||||||||
| Plus: Depreciation | 0.32 | 0.31 | 0.99 | 0.86 | ||||||||||||||||||||||
| Plus: Amortization of intangibles | 0.20 | 0.01 | 0.23 | 0.08 | ||||||||||||||||||||||
| Plus: Other | 0.00 | 0.00 | 0.00 | 0.01 | ||||||||||||||||||||||
| Plus: Impairment of equity investments | 0.00 | 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, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| 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 income | 1,200,000 | — | 1,300,000 | ||||||||||||||
Plus: Adjustments to arrive at Non-GAAP1 | 700,000 | — | 700,000 | ||||||||||||||
| Non-GAAP operating income | 1,900,000 | — | 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.