ONC

EX-99.1

2 exhibit991-q22026earningsr.htm

EX-99.1

Document

Exhibit 99.1

BeOne Medicines Announces Second Quarter 2026 Financial Results and Business Updates

•Total global revenues of $1.7 billion for the second quarter, an increase of 30% from the prior year

•BRUKINSA (zanubrutinib) global revenues of $1.2 billion for the second quarter, an increase of 31% from the prior year

•Diluted GAAP Earnings per American Depository Share (ADS) of $2.05 for the second quarter; non-GAAP diluted Earnings per ADS of $3.84 for the second quarter

•Raised 2026 total revenue guidance to $6.6 to $6.8 billion; GAAP operating income of $1 to $1.1 billion, non-GAAP operating income of $1.7 to $1.8 billion

SAN CARLOS, Calif. – August 5, 2026 – BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the second quarter of 2026.

John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:

“These strong second-quarter results underscore our continued growth as a global oncology leader. Our foundational hematology franchise, led by BRUKINSA, continues to gain momentum as we advance one of the industry’s deepest and most diverse pipelines. With differentiated capabilities spanning drug discovery, clinical development, manufacturing, and commercialization, we are well positioned for our next phase of global growth.”

(Amounts in thousands of U.S. dollars and unaudited)

Three Months EndedSix Months Ended

June 30,June 30,

20262025% Change20262025% Change

Net product revenues$1,679,794 $1,302,076 29 %$3,167,123 $2,410,606 31 %

Other revenue$25,277 $13,224 91 %$51,386 $21,973 134 %

Total revenue$1,705,071 $1,315,300 30 %$3,218,509 $2,432,579 32 %

GAAP income from operations$325,047 $87,885 270 %$574,949 $98,987 481 %

Adjusted income from operations*$503,029 $274,945 83 %$917,423 $414,302 121 %

GAAP net income$237,007 $94,320 151 %$464,364 $95,590 386 %

Adjusted net income*$444,497 $252,822 76 %$819,539 $388,959 111 %

GAAP basic EPS per ADS$2.12 $0.87 144 %$4.17 $0.89 369 %

Adjusted basic EPS per ADS*$3.98 $2.33 71 %$7.37 $3.61 104 %

GAAP diluted EPS per ADS$2.05 $0.84 144 %$4.01 $0.85 372 %

Adjusted diluted EPS per ADS*$3.84 $2.25 71 %$7.08 $3.48 103 %

Free Cash Flow*$435,344 $219,772 98 %$595,891 $207,447 187 %

* 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

Second Quarter 2026 Financial Results

Product Revenue totaled $1.7 billion for the second quarter of 2026, representing growth of 29% compared to the prior-year period.

•BRUKINSA: Global sales totaled $1.2 billion for the second quarter of 2026, representing growth of 31% compared to the prior-year period; U.S. sales of BRUKINSA totaled $893 million in the second quarter of 2026, representing growth of 31% compared to the prior-year period.

•TEVIMBRA (tislelizumab): Global sales totaled $229 million in the second quarter of 2026, representing growth of 18% compared to the prior-year period.

•Amgen in-licensed products: Global sales totaled $157 million in the second quarter of 2026, representing growth of 25% compared to the prior-year period.

Gross Margin as a percentage of global product sales for the second quarter of 2026 was 90%, compared to 87% 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.

Operating Expenses

The following table summarizes operating expenses for the second quarter of 2026:

GAAPNon-GAAP

(unaudited, in thousands, except percentages)Q2 2026Q2 2025% ChangeQ2 2026Q2 2025% Change

Research and development $612,280 $524,896 17 %$533,950 $444,057 20 %

Selling, general and administrative $593,214 $537,913 10 %$500,674 $441,655 13 %

Total operating expenses$1,205,494 $1,062,809 13 %$1,034,624 $885,712 17 %

The following table summarizes operating expenses for the first half of 2026:

GAAPNon-GAAP

(unaudited, in thousands, except percentages)Q2 YTD 2026Q2 YTD 2025% ChangeQ2 YTD 2026Q2 YTD 2025% Change

Research and development $1,153,504 $1,006,783 15 %$999,854 $865,252 16 %

Selling, general and administrative $1,148,311 $997,201 15 %$972,667 $837,166 16 %

Total operating expenses$2,301,815 $2,003,984 15 %$1,972,521 $1,702,418 16 %

Research and Development (R&D) Expenses increased for the second 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. Upfront fees and milestone payments r

EX-99.1

2 exhibit991-q12026earningsr.htm

EX-99.1

Document

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,

20262025% 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:

GAAPNon-GAAP

(unaudited, in thousands, except percentages)Q1 2026Q1 2025% ChangeQ1 2026Q1 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

bgne-20260414

0001651308false00016513082026-04-142026-04-14

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): April 14, 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 94 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. ☐

Item 2.02. Results of Operations and Financial Condition.

On April 14, 2026, BeOne Medicines Ltd. (the “Company”) filed its 2025 Annual Report (the “STAR Annual Report”) with the Science and Technology Innovation Board (the “STAR Market”) of the Shanghai Stock Exchange, which was prepared in accordance with the listing rules of the STAR Market and the applicable securities laws and regulations of the Peoples’ Republic of China (the “PRC” and the “PRC Securities Laws”).

As required by the PRC Securities Laws, the STAR Annual Report contains additional financial information of the Company for the year ended December 31, 2025 (the “Reporting Period”), prepared in accordance with the China Accounting Standards for Business Enterprises – Basic Standard (“CAS”) and other applicable PRC accounting rules, guidance and interpretations (together with CAS, “PRC GAAP”). As required by the PRC Securities Laws, the STAR Annual Report also contains financial information of the Company for the Reporting Period prepared in accordance with PRC GAAP. PRC GAAP are different from accounting principles generally accepted in the United States (“U.S. GAAP”). The financial information regarding the Company’s gross profit margin ratio, research and development expenses allocated by key products and other research and development projects and production, sales and inventory stock units for the Reporting Period prepared in accordance with U.S. GAAP as well as a summary of the material differences between PRC GAAP and U.S. GAAP are attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

The STAR Annual Report is available to the public in Chinese language only on the website maintained by the Shanghai Stock Exchange at www.sse.com.cn. The STAR Annual Report and the information contained on the Shanghai Stock Exchange’s website are not part of this Current Report on Form 8-K and shall not be deemed filed or furnished by the Company with the U.S. Securities and Exchange Commission, nor shall they be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

The information in Item 2.02 of this Current Report on Form 8-K and in Exhibit 99.1 is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or othe