Every 8-K that BeOne Medicines Ltd. American (ONC) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ONC and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ONC filings page.
BeOne Medicines Ltd. (ONC) reported that it filed its 2026 Interim Report for the six months ended June 30, 2026 with the STAR Market of the Shanghai Stock Exchange, prepared under PRC GAAP, and furnished related U.S. GAAP information to U.S. investors. The company summarized key accounting differences between PRC GAAP and U.S. GAAP for share-based compensation, interim income tax calculation, lease presentation and the transfer of future royalty rights from a collaborative arrangement. It also disclosed a detailed U.S. GAAP breakdown of research and development expenses by key products and projects for the first half of 2026, showing total R&D expenses of US$1,153,504,000 versus US$1,006,783,000 a year earlier, including both external project spending and internal R&D costs.
BeOne Medicines reported strong Q2 2026 results, with total revenue of $1,705,071 thousand, up 30% year over year. Net product revenue was $1,679,794 thousand, driven by BRUKINSA global sales of $1.2 billion (31% growth), TEVIMBRA sales of $229 million (18% growth), and Amgen in-licensed products at $157 million (25% growth). GAAP income from operations rose to $325,047 thousand, GAAP net income to $237,007 thousand, and GAAP diluted EPS per ADS to $2.05, while adjusted diluted EPS per ADS reached $3.84. Gross margin improved to 90% from 87%, and Free Cash Flow increased to $435,344 thousand. Cash, cash equivalents and restricted cash were $5,280,674 thousand as of June 30, 2026.
Management raised 2026 guidance, now expecting total revenue of $6.6–$6.8 billion, GAAP operating income of $1.0–$1.1 billion, and non-GAAP operating income of $1.7–$1.8 billion. Updates included positive BRUKINSA Phase 3 data, FDA accelerated approval for BEQALZI in relapsed/refractory mantle cell lymphoma, Japan approval for TEVIMBRA in first-line gastric cancer, U.S. FDA Orphan Drug Designation for PRMT5 inhibitor BGB-58067, and a $300 million expansion of the Princeton West manufacturing and R&D campus.
BeOne Medicines Ltd. reports the conclusion of a statutory tax audit in China that resulted in a settlement requiring an income tax payment of approximately RMB 446 million, including surcharges and related interest. The payment stems from agreed adjustments to previously filed tax returns and involves no administrative penalty.
The company indicates this income tax payment will be recognized in its U.S. GAAP financial statements for the second quarter of fiscal 2026. The disclosure follows earlier discussion of ongoing international tax audits that may lead to outcomes different from prior estimates because of complex local tax rules.
BeOne Medicines Ltd. held its 2026 annual general meeting, where shareholders approved all 20 proposals, including financial statements, director elections and compensation items under Swiss law.
Investors approved the Fifth Amended and Restated 2016 Share Option and Incentive Plan, increasing the shares available for awards by 75,400,000 ordinary shares, and the Sixth Amended and Restated 2018 Employee Share Purchase Plan, adding a further 3,250,000 ordinary shares for employee purchases. Shareholders re-elected John V. Oyler as chairman, refreshed the board and compensation committee, and ratified Ernst & Young entities as auditors.
They also granted a general mandate allowing the board to issue up to 20% of issued shares and a separate mandate to repurchase up to 10% of ordinary shares (excluding certain categories). A Connected Person Placing Authorization was approved, permitting allocations to Amgen Inc. to maintain its ownership percentage in future offerings.
BeOne Medicines Ltd. reports that the U.S. FDA has granted accelerated approval for BEQALZI (sonrotoclax), a next-generation BCL2 inhibitor, to treat adults with relapsed or refractory mantle cell lymphoma after at least two prior systemic therapies, including a BTK inhibitor.
The decision is based on a Phase 1/2 study showing a 52% overall response rate, a 16% complete response rate, and a median duration of response of 15.8 months. Approval is conditional on confirmatory trial results, and the label carries important safety warnings, including tumor lysis syndrome and serious infections.
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.
BeOne Medicines delivered a strong 2025, with total revenue rising 40% to $5.34 billion and fourth-quarter revenue up 33% to $1.50 billion. Product revenue made up 99% of the total.
Flagship BTK inhibitor BRUKINSA generated $3.9 billion in 2025 sales, up 49%, including $2.8 billion in the U.S. TEVIMBRA added $737 million, up 19%, while Amgen in-licensed products contributed $486 million, up 33%.
GAAP net income improved to $286.9 million from a $644.8 million loss, and free cash flow reached $941.7 million. For 2026, BeOne guides total revenue to $6.2–$6.4 billion, GAAP operating income of $700–$800 million, and non-GAAP operating income of $1.4–$1.5 billion, with gross margin expected in the high-80% range.
BeOne Medicines Ltd. has fully repaid and terminated a major credit facility with China Merchants Bank Co., Ltd. The company used a portion of the borrowings from its previously disclosed Facilities Agreement, arranged with The Hongkong and Shanghai Banking Corporation Limited and other lenders, to pay off all outstanding amounts under the prior CMB Credit Facility.
As part of this repayment, all commitments by China Merchants Bank to extend further credit, as well as all guarantees and security interests granted by BeOne Medicines under the CMB Credit Facility, were terminated. The company incurred no termination penalties in connection with ending this facility.
BeOne Medicines Ltd. appointed Dr. Lai Wang as President, Global Head of Research and Development, effective January 1, 2026. In this expanded role, he will lead research and development as well as other functions, including business development and alliance management.
Dr. Wang, age 48, has led the Company’s R&D since April 2021 after joining in 2011, and previously served as Director of Research at Joyant Pharmaceuticals. His new compensation includes a $750,000 annual salary, an annual target bonus equal to 75% of base salary, and a one-time equity incentive of $10,000,000 in restricted share units vesting in four equal annual installments, with certain accelerated vesting rights under his employment agreement. The Company states there are no related-party or other arrangements connected to his appointment.
BeOne Medicines Ltd. (ONC) filed an 8-K announcing its third-quarter 2025 results. The company reported that it announced financial results for the three months ended September 30, 2025, and furnished a related press release as Exhibit 99.1 titled “BeOne Medicines Announces Third Quarter 2025 Financial Results and Business Updates.”
The information provided under Item 2.02 is being furnished and is not deemed “filed” under the Exchange Act. The filing also lists the company’s securities, including American Depositary Shares trading on Nasdaq under ONC, with each ADS representing 13 ordinary shares; the ordinary shares are listed on the Stock Exchange of Hong Kong under 06160.
BeOne Medicines Ltd. furnished an 8-K to note that its STAR Interim Report for the six months ended June 30, 2025 was prepared under PRC GAAP (China Accounting Standards) as required by PRC Securities Laws. The filing states a supplemental exhibit (Exhibit 99.1) provides the company’s research and development expenses allocated by key products and other R&D projects prepared in accordance with U.S. GAAP, plus a summary of material differences between PRC GAAP and U.S. GAAP. The STAR Interim Report is available publicly in Chinese on the Shanghai Stock Exchange website, but that report and the SSE website content are explicitly not being filed with or incorporated into the company’s U.S. SEC filings. Information in Item 2.02 and Exhibit 99.1 is being furnished, not filed, and therefore is not subject to Section 18 liabilities.
BeOne Medicines entered a royalty sale with Royalty Pharma providing an upfront payment of $885 million at closing in exchange for a significant portion of tiered mid-single-digit royalties on Imdelltra (tarlatamab) sales outside China. The Seller retains other economic rights under the Amgen Collaboration Agreement and may, through August 25, 2026, exercise a put option to sell an additional portion of royalties for up to $65 million. The Seller will share in royalties on annual Imdelltra ex-China net revenue above $1.5 billion. All Amgen royalty payments to the Seller are to be deposited into an escrow account, and the agreement includes customary representations, warranties, covenants and indemnities. BeOne expects the upfront payment to become a material direct financial obligation at closing. The filing also discloses forward-looking statements and enumerates clinical, regulatory, intellectual property, funding and third-party risks.