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BeOne Medicines Ltd. 8-K Report, Financial Results (Feb 26, 2026)

Reports
Earnings & Results·Exhibits & Filings
Filing Date
Filed February 26, 2026
Period End
February 26, 2026
Securities
ONCBEIGF
In the record · 2016–202610-K1310-Q328-K284

ONC filed 13 annual reports (10-K), 32 quarterly reports (10-Q) and 284 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · Jan ’18Jan ’18
  2. Leadership change8-K · Jun ’20Jun ’20
  3. Leadership change8-K · Jun ’22Jun ’22
  4. Material agreement8-K · Dec ’24Dec ’24

01—Abstract

Summary

Summary of the 8-K filed February 26, 2026. Cited figures are marked; the original filing is the authoritative source.

BeOne Medicines (ONC) reported strong fourth quarter and full-year 2025 results, with total revenue of $1.50 billiona in Q4 (up 33% year over year) and $5.34 billion for the full year (up 40%).

Growth was driven overwhelmingly by BRUKINSA (zanubrutinib), which generated $1.1 billionb globally in Q4 and $3.9 billion for the year (up 38% and 49%, respectively). U.S. BRUKINSA sales reached $2.8 billion for the full year. Profitability improved sharply: GAAP operating income swung to $447 million for 2025 from a $568 million loss in 2024, GAAP net income was $287 million versus a $645 million loss, and free cash flow reached $942 million.

Gross margin on a GAAP basis expanded to 87.3% for the year, reflecting product mix and operating leverage. management guided to 2026 total revenue of $6.2 to $6.4 billionc, a GAAP gross margin in the high-80% range, GAAP operating income of $700 to $800 million, and non-GAAP operating income of $1.4 to $1.5 billion. Notably, management flagged that earnings may support a reversal of certain deferred tax valuation allowances in 2026, which could produce a material one-time tax benefit, though timing and size are uncertain. Other income/expense is expected to be a $25 to $50 million expense, and diluted ADS outstanding is projected at about 118 million.

The pipeline update centers on near-term regulatory and data catalysts, including FDA action on sonrotoclax for relapsed/refractory mantle cell lymphoma (priority review granted), a Phase 3 MANGROVE interim analysis in first-line MCL in 1H 2026, and planned TEVIMBRA sBLA submissions for first-line HER2-positive gastroesophageal adenocarcinoma. Investors should note that the results were disclosed via an Item 2.02 furnishing (Exhibit 99.1), and that the quarter included about $76 milliond of full-year equity investment impairments and $45 million of tax items, which weighed on GAAP net income.

02—Key points

Key Highlights

  1. Total revenue of $1.50B in Q4 2025 (+33% YoY) and $5.34B for FY2025 (+40% YoY), with product revenue representing 99% of total.
  2. BRUKINSA global sales of $1.1B in Q4 (+38%) and $3.9B for FY2025 (+49%); U.S. BRUKINSA sales were $2.8B for the year (+45%).
  3. GAAP operating income of $447M for FY2025 versus a $568M loss in FY2024; GAAP net income of $287M versus a $645M loss.
  4. Free cash flow of $942M for FY2025, an increase of $1.6B year over year, and cash, cash equivalents and restricted cash rose to $4.6B at year-end.
  5. FY2026 guidance: total revenue of $6.2–6.4B, GAAP gross margin in the high-80% range, GAAP operating income of $700–800M, and non-GAAP operating income of $1.4–1.5B.
  6. Potential reversal of deferred tax valuation allowances in 2026 could produce a material, though uncertain, one-time income tax benefit.
  7. Near-term catalysts include FDA action on sonrotoclax in R/R MCL, the Phase 3 MANGROVE interim analysis in 1H 2026, and TEVIMBRA sBLA submissions in U.S. and China for first-line HER2-positive GEA.

03—Questions

Frequently Asked Questions

  1. What drove BeOne's revenue growth in 2025?

    Growth was driven primarily by BRUKINSA, whose global sales rose 49% to $3.9 billion for the full year, with U.S. sales up 45% to $2.8 billion. TEVIMBRA grew 19% to $737 million, and Amgen in-licensed products grew 33% to $486 million.

  2. Is BeOne now profitable on a GAAP basis?

    Yes, for full-year 2025 BeOne reported GAAP income from operations of $447 million and GAAP net income of $287 million, compared with an operating loss of $568 million and a net loss of $645 million in 2024. Q4 2025 GAAP net income was $67 million, though it included equity investment impairments and tax charges.

  3. What does the 2026 guidance imply for investors?

    Management guided to 2026 total revenue of $6.2–6.4 billion and GAAP operating income of $700–800 million, implying continued top-line growth and further operating leverage. Guidance excludes any new business development activity or unusual items, and the company expects diluted ADS outstanding of about 118 million.

  4. Could BeOne record a large tax benefit in 2026?

    Possibly. Management said 2026 earnings may provide sufficient positive evidence to reverse certain valuation allowances on deferred tax assets, which would result in a material tax benefit. The timing and magnitude are uncertain, and until then income tax expense should track earnings under historical relationships.

  5. What are the key pipeline catalysts to watch in 2026?

    Key 1H 2026 milestones include the FDA regulatory decision on sonrotoclax for relapsed/refractory mantle cell lymphoma (granted priority review), the Phase 3 MANGROVE interim analysis of BRUKINSA in first-line MCL, and sBLA submissions for TEVIMBRA in first-line HER2-positive GEA in the U.S. and China.

04—Continue

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