BeOne Medicines (NASDAQ: ONC) boosts 2026 outlook after strong Q1 revenue

Rhea-AI Filing Summary

BeOne Medicines reported a very strong first quarter of 2026, with total revenue of $1.51 billion, up 35% from the prior year. Net product revenue was $1.49 billion, driven mainly by oncology medicines.

Flagship BTK inhibitor BRUKINSA generated global sales of $1.1 billion, up 38%, including U.S. sales of $761 million (up 35%). TEVIMBRA reached $206 million in global sales, while Amgen in-licensed products contributed $142 million.

GAAP income from operations rose to $249.9 million and GAAP net income to $227.4 million, compared with nearly break-even a year earlier. GAAP diluted earnings were $1.96 per ADS, and non‑GAAP diluted earnings were $3.24 per ADS. Free cash flow improved to $160.5 million from negative levels.

The company raised full‑year 2026 guidance, now expecting total revenue of $6.3 billion–$6.5 billion and GAAP operating income of $750 million–$850 million. Management highlighted a broad oncology pipeline with multiple late‑stage milestones and regulatory decisions anticipated through 2026–2027.

Positive

• Revenue and profit inflection: Total revenue rose 35% year over year to $1.51 billion, while GAAP net income increased to $227.4 million from near break‑even, showing strong operating leverage.
• Upgraded 2026 outlook: Management raised full‑year 2026 guidance for total revenue to $6.3–$6.5 billion and GAAP operating income to $750–$850 million, indicating confidence in continued growth.
• Robust oncology portfolio: BRUKINSA’s $1.1 billion in quarterly sales, TEVIMBRA growth, and multiple late‑stage pipeline and regulatory milestones highlight a diversified, advancing cancer franchise.

Negative

• None.

Insights

Biopharma equity analyst

Q1 2026 shows breakout profitability, stronger guidance, and deepening oncology momentum.

BeOne delivered $1.51 billion in Q1 2026 revenue, up 35%, with BRUKINSA contributing $1.1 billion and gaining share. GAAP net income jumped to $227.4 million, and GAAP diluted EPS per ADS rose to $1.96, reflecting strong operating leverage.

Non‑GAAP diluted EPS per ADS of $3.24 and free cash flow of $160.5 million underscore improving cash generation. Management raised 2026 revenue guidance to $6.3–$6.5 billion and GAAP operating income to $750–$850 million, signaling confidence in demand and cost control.

The pipeline remains active: multiple programs, including TEVIMBRA, sonrotoclax, BGB‑16673, and GPC3x41BB bispecific BGB‑B2033, have key clinical or regulatory events in 2026–2027. Actual value will depend on regulatory outcomes, competitive dynamics in hematology and solid tumors, and execution on global launches.

8-K Event Classification

5 items: 0.00, 0.03, 0.05, 2.02, 9.01

5 items

Item 0.00 Item 0.00

Item 0.03 Item 0.03

Item 0.05 Item 0.05

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, and exhibit attachments filed with this report.

Key Figures

Total revenue Q1 2026: $1.51B BRUKINSA global revenue: $1.1B GAAP net income: $227.4M +5 more

8 metrics

Total revenue Q1 2026 $1.51B Three months ended March 31, 2026; +35% year over year

BRUKINSA global revenue $1.1B Q1 2026 global sales; +38% year over year

GAAP net income $227.4M Three months ended March 31, 2026; up from $1.3M

GAAP diluted EPS per ADS $1.96 Q1 2026, vs. $0.01 prior year

Non-GAAP diluted EPS per ADS $3.24 Three months ended March 31, 2026; up from $1.22

Free cash flow $160.5M Q1 2026, vs. -$12.3M in Q1 2025

Cash and equivalents $4.85B Balance at March 31, 2026

2026 revenue guidance $6.3B–$6.5B Updated full-year 2026 total revenue outlook

Key Terms

non-GAAP diluted Earnings per ADS, Free Cash Flow, Orphan Drug Designation, Supplemental Biologics License Application, +2 more

6 terms

non-GAAP diluted Earnings per ADS financial

"non-GAAP diluted Earnings per ADS of $3.24 for the first quarter"

Free Cash Flow financial

"Free Cash Flow for the first quarter of 2026 was $161 million"

Free cash flow is the amount of money a company has left over after paying all its expenses and investing in its business, like buying equipment or updating facilities. It shows how much cash is available to reward shareholders, pay down debt, or save for future growth. This helps investors understand if a company is financially healthy and able to grow.

Orphan Drug Designation regulatory

"Received Orphan Drug Designation in Japan for the treatment of adult patients"

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.

Supplemental Biologics License Application regulatory

"Received acceptance of a Supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration"

A supplemental biologics license application is a formal request to a regulator (such as the U.S. Food and Drug Administration) asking permission to change an already approved biological product — for example to add a new use, change how it’s made, or alter dosing. For investors, an approved supplemental application can expand a product’s sales or reduce manufacturing risk, while a delay or rejection can limit revenue prospects or raise compliance costs; think of it like applying for an update to a building permit for an existing, income-producing property.

Phase 3 study initiation technical

"Phase 3 study initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer"

trispecific antibody technical

"a novel trispecific antibody targeting PD-1, VEGF-A and CTLA-4"

A trispecific antibody is a lab-designed protein that can attach to three different biological targets or sites at once, like a three-pronged tool that grabs multiple parts of a problem simultaneously. For investors, trispecifics matter because they can enable more precise or potent therapies than single-target drugs, which may translate into greater clinical benefit, higher commercial value and distinct risks around development complexity and regulatory review that can move a company’s stock.

Earnings Snapshot

Total revenue: $1.51B · Guidance included

Q1 2026

Total revenue $1.51B +35% YoY

Net product revenue $1.49B +34% YoY

GAAP net income $227.4M up from $1.3M YoY

GAAP diluted EPS per ADS $1.96 vs. $0.01 prior year

Non-GAAP diluted EPS per ADS $3.24 vs. $1.22 prior year

Free cash flow $160.5M vs. -$12.3M prior year

Guidance

For full year 2026, BeOne expects total revenue of $6.3–$6.5 billion, GAAP operating income of $750–$850 million, and non-GAAP operating income of $1.45–$1.55 billion, assuming May 1, 2026 foreign exchange rates and no major new business development.

Understanding 8-K Material Events →

0001651308false00016513082026-05-062026-05-06

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): May 6, 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 class

Trading Symbol(s)

Name of each exchange on which registered

American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share

ONC

The Nasdaq Global Select Market

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 May 6, 2026, BeOne Medicines Ltd. announced its financial results for the three months ended March 31, 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 First Quarter 2026 Financial Results and Business Updates” issued by BeOne Medicines Ltd. on May 6, 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						Press release titled “BeOne Medicines Announces First Quarter 2026 Financial Results and Business Updates” issued by BeOne Medicines Ltd. on May 6, 2026
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: May 6, 2026			By:			/s/ Chan Lee
			Name:			Chan Lee
			Title:			Senior Vice President, General Counsel

Exhibit 99.1

BeOne Medicines Announces First Quarter 2026 Financial Results and Business Updates

•Total global revenues of $1.5 billion for the first quarter, an increase of 35% from the prior year

•Foundational BRUKINSA (zanubrutinib) global revenues of $1.1 billion for the first quarter, an increase of 38% from the prior year

•Diluted GAAP Earnings per American Depository Share (ADS) of $1.96 for the first quarter; non-GAAP diluted Earnings per ADS of $3.24 for the first quarter

SAN CARLOS, Calif. – May 6, 2026 – BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the first quarter of 2026.

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, 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.

Exhibit 99.1

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.

Exhibit 99.1

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) 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.

Exhibit 99.1

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.

•BG-C9074 (B7-H4 ADC): Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO.

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.

Lung Cancer

•BG-C0979 (ADAM9-targeting ADC): Initiated first-in-human study.

Inflammation and Immunology

•BG-A3004 (KLRG1 mAb): Initiated first-in-human study.

Exhibit 99.1

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
TEVIMBRA			•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
			•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 Cancers			•BGB-43395 (CDK4 inhibitor):
			◦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 Cancers			•BGB-B2033 (GPC3x41BB bispecific antibody):
			◦Pivotal Phase 3 study initiation.			2H 2026
Inflammation and Immunology			•BGB-16673 (BTK CDAC):
			◦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.

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.

Exhibit 99.1

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 growth as a global oncology leader; the fixed-duration combination of sonrotoclax and BRUKINSA as a potential new standard-of-care in first-line CLL; the emergence of BGB-16673 as a potential first-in-class therapy for R/R CLL; BeOne’s future revenue, gross margin percentage, operating expenses, operating income, other income or expense, income tax and diluted ADS outstanding; 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						Kyle Blankenship
+1 857-302-5663						+1 667-351-5176
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 March 31,
			2026						2025
			(Unaudited)
Revenues
Product revenue, net			$	1,487,329					$	1,108,530
Other revenue			26,109						8,749
Total revenues			1,513,438						1,117,279
Cost of sales - products			167,215						165,002
Gross profit			1,346,223						952,277
Operating expenses:
Research and development			541,224						481,887
Selling, general and administrative			555,097						459,288
Total operating expenses			1,096,321						941,175
Income from operations			249,902						11,102
Interest income			27,664						12,850
Interest expense			(32,887)						(7,002)
Other income, net			14,536						3,950
Income before income taxes			259,215						20,900
Income tax expense			31,858						19,630
Net income			$	227,357					$	1,270
Earnings per share
Basic			$	0.16					$	0.00
Diluted			$	0.15					$	0.00
Weighted-average shares outstanding—basic			1,442,451,870						1,390,052,966
Weighted-average shares outstanding—diluted			1,505,027,338						1,445,253,219
Earnings per American Depositary Share (“ADS”)
Basic			$	2.05					$	0.01
Diluted			$	1.96					$	0.01
Weighted-average ADSs outstanding—basic			110,957,836						106,927,151
Weighted-average ADSs outstanding—diluted			115,771,334						111,173,325

Exhibit 99.1

Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)

(Amounts in thousands of U.S. Dollars)

			As of
			March 31,						December 31,
			2026						2025
			(unaudited)						(audited)
Assets:
Cash, cash equivalents and restricted cash			$	4,853,425					$	4,609,647
Accounts receivable, net			938,019						865,080
Inventories			681,590						608,227
Property, plant and equipment, net			1,640,918						1,641,678
Total assets			$	8,553,619					$	8,188,573
Liabilities and equity:
Accounts payable			$	423,546					$	479,035
Accrued expenses and other payables			1,079,283						1,109,120
R&D cost share liability			35,700						64,345
Sale of future royalty liability			904,399						906,956
Debt			1,078,655						1,019,206
Total liabilities			3,793,177						3,827,379
Total equity			$	4,760,442					$	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 March 31,
						2026						2025
						(unaudited)
Cash, cash equivalents and restricted cash at beginning of period						$	4,609,647					$	2,638,747
Net cash provided by operating activities						201,336						44,082
Net cash used in investing activities						(45,510)						(121,941)
Net cash provided by (used in) financing activities						68,632						(33,777)
Net effect of foreign exchange rate changes						19,320						3,480
Net increase (decrease) in cash, cash equivalents, and restricted cash						243,778						(108,156)
Cash, cash equivalents and restricted cash at end of period						$	4,853,425					$	2,530,591

Exhibit 99.1

Note Regarding Use of Non-GAAP Financial Measures

BeOne provides certain non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Operating Loss, 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
			March 31,
			2026						2025
Reconciliation of GAAP to adjusted cost of sales - products:
GAAP cost of sales - products			$	167,215					$	165,002
Less: Depreciation			4,326						2,613
Less: Amortization of intangibles			1,742						1,173
Adjusted cost of sales - products			$	161,147					$	161,216
Reconciliation of GAAP to adjusted research and development:
GAAP research and development			$	541,224					$	481,887
Less: Share-based compensation cost			53,856						41,767
Less: Depreciation			21,464						18,925
Adjusted research and development			$	465,904					$	421,195
Reconciliation of GAAP to adjusted selling, general and administrative:
GAAP selling, general and administrative			$	555,097					$	459,288
Less: Share-based compensation cost			69,492						53,684
Less: Depreciation			13,595						10,076
Less: Amortization of intangibles			17						17
Adjusted selling, general and administrative			$	471,993					$	395,511
Reconciliation of GAAP to adjusted operating expenses
GAAP operating expenses			$	1,096,321					$	941,175
Less: Share-based compensation cost			123,348						95,451
Less: Depreciation			35,059						29,001
Less: Amortization of intangibles			17						17
Adjusted operating expenses			$	937,897					$	816,706
Reconciliation of GAAP to adjusted income from operations:
GAAP income from operations			$	249,902					$	11,102
Plus: Share-based compensation cost			123,348						95,451
Plus: Depreciation			39,385						31,614
Plus: Amortization of intangibles			1,759						1,190
Adjusted income from operations			$	414,394					$	139,357
Reconciliation of GAAP to adjusted net income:
GAAP net income			$	227,357					$	1,270
Plus: Share-based compensation expenses			123,348						95,451
Plus: Depreciation			39,385						31,614
Plus: Amortization of intangibles			1,759						1,190
Plus: Impairment of equity investments			—						12,376
Plus: Discrete tax items			3,535						5,473
Plus: Income tax effect of non-GAAP adjustments1			(20,342)						(11,237)
Adjusted net income			$	375,042					$	136,137

Exhibit 99.1

			Three Months Ended
			March 31,
			2026						2025
Reconciliation of GAAP to adjusted EPS - basic
GAAP earnings per share - basic			$	0.16					$	0.00
Plus: Share-based compensation expenses			0.09						0.07
Plus: Depreciation			0.03						0.02
Plus: Amortization of intangibles			0.00						0.00
Plus: Impairment of equity investments			0.00						0.01
Plus: Discrete tax items			0.00						0.00
Plus: Income tax effect of non-GAAP adjustments1			(0.01)						(0.01)
Adjusted earnings per share - basic			$	0.26					$	0.10
Reconciliation of GAAP to adjusted EPS - diluted
GAAP earnings per share - diluted			$	0.15					$	0.00
Plus: Share-based compensation expenses			0.08						0.07
Plus: Depreciation			0.03						0.02
Plus: Amortization of intangibles			0.00						0.00
Plus: Impairment of equity investments			0.00						0.01
Plus: Discrete tax items			0.00						0.00
Plus: Income tax effect of non-GAAP adjustments1			(0.01)						(0.01)
Adjusted earnings per share - diluted			$	0.25					$	0.09
Reconciliation of GAAP to adjusted earnings per ADS - basic
GAAP earnings per ADS - basic			$	2.05					$	0.01
Plus: Share-based compensation expenses			1.11						0.89
Plus: Depreciation			0.35						0.30
Plus: Amortization of intangibles			0.02						0.01
Plus: Impairment of equity investments			0.00						0.12
Plus: Discrete tax items			0.03						0.05
Plus: Income tax effect of non-GAAP adjustments1			(0.18)						(0.11)
Adjusted earnings per ADS - basic			$	3.38					$	1.27
Reconciliation of GAAP to adjusted earnings per ADS - diluted
GAAP earnings per ADS - diluted			$	1.96					$	0.01
Plus: Share-based compensation expenses			1.07						0.86
Plus: Depreciation			0.34						0.28
Plus: Amortization of intangibles			0.02						0.01
Plus: Impairment of equity investments			0.00						0.11
Plus: Discrete tax items			0.03						0.05
Plus: Income tax effect of non-GAAP adjustments1			(0.18)						(0.10)
Adjusted earnings per ADS - diluted			$	3.24					$	1.22

1Tax 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
						March 31,
						2026						2025
Free Cash Flow (Non-GAAP):
Net cash provided by operating activities (GAAP)						$	201,336					$	44,082
Less: Purchases of property, plant and equipment						(40,789)						(56,407)
Free Cash Flow (Non-GAAP)						$	160,547					$	(12,325)

Exhibit 99.1

Reconciliation of GAAP Operating Income Guidance to Non-GAAP
Operating Income Guidance for Full Year 2026
			(Unaudited)
GAAP operating income			750,000						—						850,000
Plus: Adjustments to arrive at Non-GAAP1			700,000						—						700,000
Non-GAAP operating income			1,450,000						—						1,550,000

1.The non-GAAP adjustments are based on best available information at this time related to non-cash items similar to those reported in our actual Non-GAAP results.

FAQ

How did BeOne Medicines (ONC) perform financially in Q1 2026?

BeOne Medicines reported strong Q1 2026 results, with total revenue of $1.51 billion, up 35% year over year. GAAP net income increased to $227.4 million, and GAAP diluted earnings reached $1.96 per ADS, reflecting improved margins and operating leverage.

What drove BeOne Medicines’ revenue growth in Q1 2026?

Revenue growth was led by oncology drug BRUKINSA, which delivered $1.1 billion in global sales, up 38%. Additional contributions came from TEVIMBRA with $206 million in sales and Amgen in‑licensed products totaling $142 million, all growing double digits.

How did BeOne Medicines’ earnings and cash flow change in Q1 2026?

GAAP income from operations rose to $249.9 million and GAAP net income to $227.4 million, versus minimal profit last year. GAAP diluted EPS per ADS was $1.96, while free cash flow improved to $160.5 million, up from a negative figure in Q1 2025.

Did BeOne Medicines update its full-year 2026 guidance?

Yes. BeOne now expects $6.3–$6.5 billion in 2026 total revenue, up from prior $6.2–$6.4 billion, and GAAP operating income of $750–$850 million. Non‑GAAP operating income guidance increased to $1.45–$1.55 billion, reflecting stronger anticipated performance.

What are the key oncology products for BeOne Medicines (ONC)?

BeOne’s core products include BRUKINSA (BTK inhibitor) with $1.1 billion in quarterly sales and TEVIMBRA (tislelizumab) at $206 million. Amgen in‑licensed therapies added $142 million. These medicines anchor the company’s hematology and solid tumor portfolio.

What major pipeline and regulatory milestones does BeOne Medicines expect?

Upcoming milestones include TEVIMBRA regulatory actions in the U.S., Japan, and China for HER2‑positive gastroesophageal adenocarcinoma, sonrotoclax and BGB‑16673 studies in hematologic cancers, and pivotal development of bispecific antibody BGB‑B2033. Several events are planned across 2026–2027.

How strong is BeOne Medicines’ balance sheet at the end of Q1 2026?

As of March 31, 2026, BeOne held $4.85 billion in cash, cash equivalents, and restricted cash, with total assets of $8.55 billion. Total liabilities were $3.79 billion, including $1.08 billion of debt, supporting continued investment in R&D and commercialization.

Filing Exhibits & Attachments

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