BeOne Medicines Ltd.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-05.
0001628280-26-052878
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001628280-26-070477
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 132 previous paragraphs and 134 current paragraphs.
66 unchanged; 59 reworded; 9 added; 7 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 16 previous and 16 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
•BRUKINSA® (zanubrutinib) global revenues increased 34% to $1.4 billion versus third quarter 2025
Current report
On August 31, 2026, we announced our entry into a voluntary agreement with the U.S. government to expand access to innovative cancer medicines for American patients while strengthening our U.S. manufacturing footprint and further expanding the capabilities needed to deliver medicines at scale.
Current report
On August 31, 2026, we announced positive topline results from the second interim analysis of the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), in combination with chemotherapy, with and without TEVIMBRA® (tislelizumab), as first-line treatment for HER2-positive (“HER2+”) locally advanced or metastatic gastroesophageal adenocarcinoma (“GEA”).
Current report
On August 25, 2026, we announced that the U.S. Food and Drug Administration (“FDA”) approved the supplemental Biologics License Application (“sBLA”) for TEVIMBRA in combination with ZIIHERA and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or GEA.
Current report
On August 18, 2026, we announced the renewal of our partnership with the BeOne Care Foundation and The Max Foundation through 2028 to expand access to BRUKINSA® (zanubrutinib) for the treatment of chronic lymphocytic leukemia in low- and middle-income countries, with the program projected to support approximately 1,000 patients cumulatively.
Current report
On August 10, 2026, we announced a multi-part collaboration with Revolution Medicines, Inc., including: a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from our pipeline with any of Revolution Medicines’ four clinical RAS(ON) inhibitors; and a separate regional rights agreement granting us exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets.
Current report
Other Income (Expense), Net
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
Other Income (Expense), Net
Removed paragraphs (7)
Previous report
•Global BRUKINSA® (zanubrutinib) revenues increased 31% to $1.2 billion versus second quarter 2025
Previous report
On July 23, 2026, we announced a $300 million expansion of our flagship clinical and commercial-stage manufacturing and research and development center at the Princeton West Innovation Campus in Hopewell, New Jersey, to add small molecule manufacturing capabilities.
Previous report
On June 30, 2026, we announced positive topline results from the Phase 3 MANGROVE study (BGB-3111-306) evaluating foundational Bruton’s tyrosine kinase (“BTK”) inhibitor BRUKINSA® plus rituximab versus bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma (“MCL”).
Previous report
On May 13, 2026, we announced that the U.S. Food and Drug Administration (“FDA”) granted accelerated approval to BEQALZI™ (sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) MCL, after at least two lines of systemic therapy, including a BTK inhibitor.
Previous report
Other Expense (Income), Net
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
Other Income, Net
Reworded paragraphs (59)
Previous wording
We provide certain financial measures that are not defined under accounting principles generally accepted in the United States of America (“GAAP”), commonly referred to as non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Income (Loss) from Operations, Adjusted Net Income (Loss), Adjusted Earnings Per Share, Free Cash Flow and certain other non-GAAP measures, each of which include adjustments to GAAP figures. These non-GAAP measures are intended to provide additional information on our operating performance. Adjustments to our 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 US GAAP current tax effect. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects in our tax expense. We maintain an established non-GAAP policy that guides the determination of what items may be excluded in non-GAAP financial measures. We believe that these non-GAAP measures, when considered together with the GAAP figures, can enhance an overall understanding of our operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of our 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 our performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, GAAP financial measures. 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.
Current wording
We provide certain financial measures that are not defined under accounting principles generally accepted in the United States of America (“GAAP”), commonly referred to as non-GAAP financial measures, including Adjusted Cost of Sales- Product, Adjusted Operating Expenses, Adjusted Income (Loss) from Operations, Adjusted Income Tax Expense, Adjusted Net Income (Loss), Adjusted Earnings Per Share, Free Cash Flow and certain other non-GAAP measures, each of which include adjustments to GAAP figures. These non-GAAP measures are intended to provide additional information on our operating performance. Adjustments to our 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 US GAAP current tax effect. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects in our tax expense. We maintain an established non-GAAP policy that guides the determination of what items may be excluded in non-GAAP financial measures. We believe that these non-GAAP measures, when considered together with the GAAP figures, can enhance an overall understanding of our operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of our 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 our performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, GAAP financial measures. 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.
Previous wording
Key highlights for the second quarter of 2026 are as follows:
Current wording
Key highlights for the third quarter of 2026 are as follows:
Previous wording
•Second quarter 2026 total global revenues increased 30% to $1.7 billion versus second quarter 2025
Current wording
•Third quarter 2026 total global revenues increased 34% to $1.9 billion versus third quarter 2025
Previous wording
•Diluted GAAP Earnings per American Depositary Share (“ADS”) of $2.05, non-GAAP diluted Earnings per ADS of $3.84.
Current wording
•Diluted GAAP Earnings per American Depositary Share (“ADS”) of $3.28, non-GAAP diluted Earnings per ADS of $4.59.
Previous wording
The following table summarizes our results of operations for the three and six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our results of operations for the three and nine months ended September 30, 2026 and 2025:
Previous wording
Total revenue increased to $1,705.1 million for the three months ended June 30, 2026, from $1,315.3 million for the three months ended June 30, 2025, due to increased sales of BRUKINSA, TEVIMBRA, as well as increased sales of in-licensed products from Amgen.
Current wording
Total revenue increased to $1,889.8 million for the three months ended September 30, 2026, from $1,412.3 million for the three months ended September 30, 2025, due to increased sales of BRUKINSA and TEVIMBRA, as well as increased sales of in-licensed products from Amgen.
Previous wording
Net product revenue increased 29.0% to $1,679.8 million for the three months ended June 30, 2026, compared to $1,302.1 million in the prior-year period, primarily due to increased sales of BRUKINSA globally, driven by significant growth in the U.S. and Europe. In addition, product revenues in the second quarter of 2026 were positively impacted by growth from in-licensed products from Amgen and TEVIMBRA.
Current wording
Net product revenue increased 33.0% to $1,855.1 million for the three months ended September 30, 2026, compared to $1,395.0 million in the prior-year period, primarily due to increased sales of BRUKINSA globally, driven by growth in the U.S. and Europe. In addition, product revenues in the third quarter of 2026 were positively impacted by growth from in-licensed products from Amgen and TEVIMBRA.
Previous wording
Global sales of BRUKINSA totaled $1,247.6 million in the second quarter, representing a 31.4% increase compared to the prior-year period; U.S. sales of BRUKINSA totaled $892.5 million in the second quarter, compared to $683.7 million in the prior-year period, representing growth of 30.5%, driven primarily by robust demand growth. BRUKINSA continues to maintain its leading new patient share across the BTKi class due to its differentiated, best-in-class clinical profile. BRUKINSA sales in the EU totaled $195.6 million in the second quarter, compared to $150.5 million in the prior-year period, representing growth of 30.0%, driven by continued gains in market share across all major markets, including Germany, Italy, Spain, France and the UK. BRUKINSA sales in China totaled $97.2 million, representing growth of 16.7%. Foreign exchange contributed approximately 7% of the China growth given the Renminbi strengthening on a year-over-year basis. BRUKINSA rest of world revenue totaled $62.4 million in the second quarter, representing growth of 92.1% compared to the prior-year period.
Current wording
Global sales of BRUKINSA totaled $1,390.9 million in the third quarter, representing a 33.7% increase compared to the prior-year period; U.S. sales of BRUKINSA totaled $1,005.1 million in the third quarter, compared to $738.7 million in the prior-year period, representing growth of 36.1%, driven primarily by demand growth. BRUKINSA sales in Europe totaled $217.6 million in the third quarter, compared to $163.2 million in the prior-year period, representing growth of 33.3%, driven by continued gains in market share across all major markets, including Germany, Italy, Spain, France and the UK. BRUKINSA sales in China totaled $103.1 million, representing growth of 11.6%. BRUKINSA rest of world revenue totaled $65.2 million in the third quarter, representing growth of 40.4% compared to the prior-year period.
Previous wording
Sales of TEVIMBRA totaled $228.5 million in the second quarter, compared to $193.5 million in the prior-year period, representing an 18.1% increase.
Current wording
Sales of TEVIMBRA totaled $243.3 million in the third quarter, compared to $190.6 million in the prior-year period, representing an 27.6% increase.
Previous wording
Revenue for Amgen products in China totaled $157.3 million in the second quarter, compared to $126.3 million in the prior-year period, representing a 24.5% increase, driven primarily by increased XGEVA® sales volume.
Current wording
Revenue for Amgen products in China totaled $167.0 million in the third quarter, compared to $133.1 million in the prior-year period, representing a 25.5% increase, driven primarily by increased XGEVA® sales volume.
Previous wording
Other revenue totaled $25.3 million and $13.2 million for the three months ended June 30, 2026 and 2025, respectively, primarily related to royalty revenue under the Amgen collaboration and revenue generated under the Novartis broad markets marketing and promotion agreement.
Current wording
Other revenue totaled $34.8 million and $17.3 million for the three months ended September 30, 2026 and 2025, respectively, primarily related to royalty revenue under the Amgen collaboration and revenue generated under the Novartis broad markets marketing and promotion agreement.
Previous wording
Gross margin as a percentage of product sales increased to 89.6% for the three months ended June 30, 2026, from 87.4% in the comparable period of the prior year. 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 production productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 90.0%, from 88.1% in the comparable period of the prior year.
Current wording
Gross margin as a percentage of product sales increased to 88.3% for the three months ended September 30, 2026, from 85.9% in the comparable period of the prior year. 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 production productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA, which was offset by a non-cash intangible asset impairment charge of $22.0 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 89.9%, from 86.3% in the comparable period of the prior year.
Previous wording
Research and development expense increased by $87.4 million, or 16.6%, to $612.3 million for the three months ended June 30, 2026 from $524.9 million for the three months ended June 30, 2025. The following table summarizes the external cost of development programs, upfront license and development milestone fees, and internal research and development expense for the three months ended June 30, 2026 and 2025, respectively:
Current wording
Research and development expense increased by $137.1 million, or 26.2%, to $660.8 million for the three months ended September 30, 2026 from $523.7 million for the three months ended September 30, 2025. The following table summarizes the external cost of development programs, upfront license and development milestone fees, and internal research and development expense for the three months ended September 30, 2026 and 2025, respectively:
Previous wording
Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the three months ended June 30, 2026 totaled $59.8 million, of which $30.3 million was recorded as R&D expense. The remaining $29.5 million was recorded as a reduction for the R&D cost share liability.
Current wording
Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the three months ended September 30, 2026 totaled $12.2 million, of which $6.0 million was recorded as R&D expense. The remaining $6.2 million was recorded as a reduction of the R&D cost share liability.
Previous wording
External research and development expenses increased in the second quarter of 2026 compared to the same period in 2025. This was primarily driven by increased investment in the continued advancement of several programs across the pipeline, including BTK CDAC, CDK4, PRMT5 and GPC3x4-1BB bsAb, higher Amgen co-development expenses, and higher development upfront and milestone fees.
Current wording
External research and development expenses increased in the third quarter of 2026 compared to the same period in 2025. This was primarily driven by increased investment in the continued advancement of several programs across the pipeline, including BTK CDAC, CDK4, PRMT5 and GPC3x4-1BB bsAb, offset by decreased Amgen co-development expenses as we met the co-funding cap under the collaboration during the quarter.
Previous wording
Internal research and development expense increased by $49.3 million, or 15.6%, to $364.7 million for the three months ended June 30, 2026, from $315.4 million for the three months ended June 30, 2025, as we continue to invest in capabilities to support a growing portfolio. This increase was primarily attributable to the expansion of resources within the global development organization, alongside higher spending for toxicology studies, reagents, and consumables necessary to advance our clinical and preclinical candidates.
Current wording
Internal research and development expense increased by $104.0 million, or 32.5%, to $423.7 million for the three months ended September 30, 2026, from $319.8 million for the three months ended September 30, 2025, as we continue to invest in capabilities to support a growing portfolio. This increase was primarily attributable to the expansion of resources within the global development organization, alongside higher spending for toxicology studies, reagents, and consumables necessary to advance our clinical and preclinical candidates.
Previous wording
Selling, general and administrative expense increased by $55.3 million, or 10.3%, to $593.2 million for the three months ended June 30, 2026, from $537.9 million for the three months ended June 30, 2025. The increase was primarily attributable to continued investment in global commercial expansion primarily in the U.S. and Europe. Selling, general and administrative expenses as a percentage of product sales were 35.3% in the second quarter of 2026 compared to 41.3% in the prior-year period.
Current wording
Selling, general and administrative expense increased by $64.5 million, or 12.2%, to $593.5 million for the three months ended September 30, 2026, from $529.0 million for the three months ended September 30, 2025. The increase was primarily attributable to continued investment in global commercial expansion primarily in the U.S. and Europe. Selling, general and administrative expenses as a percentage of product sales were 32.0% in the third quarter of 2026 compared to 37.9% in the prior-year period.
Previous wording
Interest income increased by $16.4 million, or 142.8%, to $27.9 million for the three months ended June 30, 2026, from $11.5 million for three months ended June 30, 2025. The increase in interest income was primarily attributable to a higher cash and cash equivalents balance.
Current wording
Interest income increased by $14.3 million, or 73.6%, to $33.7 million for the three months ended September 30, 2026, from $19.4 million for the three months ended September 30, 2025. The increase in interest income was primarily attributable to a higher cash and cash equivalents balance.
Previous wording
Interest expense increased by $31.7 million, or 397.0%, to $39.7 million for the three months ended June 30, 2026, from $8.0 million for three months ended June 30, 2025. The increase in interest expense was primarily attributable to interest expense recorded under the effective interest method related to the sale of future royalty liability, higher interest rates on debt balances, and lower interest capitalized related to the completion of certain phases of our Hopewell facility.
Current wording
Interest expense increased by $26.0 million, or 159.1%, to $42.4 million for the three months ended September 30, 2026, from $16.4 million for the three months ended September 30, 2025. The increase in interest expense was primarily attributable to interest expense recorded under the effective interest method related to the sale of future royalty liability, higher interest rates on debt balances, and lower interest capitalized related to the completion of certain phases of our Hopewell facility.
Previous wording
Other expense, net was $0.7 million for the three months ended June 30, 2026, primarily due to foreign exchange losses. For the three months ended June 30, 2025, other income, net was $8.2 million, primarily due to foreign exchange gains and government subsidy income, partially offset by unrealized losses on our equity investments.
Current wording
Other income, net was $0.4 million for the three months ended September 30, 2026, primarily due to government subsidy income, offset by foreign exchange losses. For the three months ended September 30, 2025, other expense, net was $19.0 million, primarily due to impairment losses recognized on our equity investments and foreign exchange losses.
Previous wording
Income tax expense was $75.5 million for the three months ended June 30, 2026 as compared to $5.2 million for the three months ended June 30, 2025. The income tax expense for the three months ended June 30, 2026 and 2025 was primarily attributable to the application of our expected current worldwide effective tax rate for the full year to year-to-date actual pre-tax income, reflecting the mix of taxable income across jurisdictions as well as the impact of certain discrete items. Specifically, the provision for income taxes for the three months ended June 30, 2026 included a discrete net tax expense of approximately $49.3 million. This figure primarily relates to the settlement of the audit of one of our China subsidiaries amounting to $59.0 million, partially offset by certain discrete items mainly related to U.S. share-based compensation. The income taxes expense for the three months ended June 30, 2025 included a discrete net tax benefit of $14.2 million, primarily related to updated provision estimates for U.S. R&D credits for prior periods.
Current wording
Income tax expense was $25.7 million for the three months ended September 30, 2026 as compared to $22.3 million for the three months ended September 30, 2025. The income tax expense for the three months ended September 30, 2026 and 2025 was primarily attributable to the application of our expected current worldwide effective tax rate for the full year to year-to-date actual pre-tax income, reflecting the mix of taxable income across jurisdictions as well as the impact of certain discrete items. Specifically, the provision for income taxes for the three months ended September 30, 2026 included a discrete net tax benefit of approximately $11.5 million, attributable mainly to U.S. share-based compensation. The income tax expense for the three months ended September 30, 2025 included a discrete net tax benefit of $0.9 million, primarily related to updated provision estimates for U.S. R&D credits for prior periods.
Previous wording
As of June 30, 2026, the Company had gross unrecognized tax benefits of $26.0 million. Due to the uncertain and complex application of income tax regulations by certain tax authorities outside of the U.S., it is possible that the ultimate resolution of ongoing audits may result in liabilities that could be different from current estimates. The ongoing tax audits in various jurisdictions could impact future tax expense if tax authorities in their administration of tax laws during open audits may lead us to change our assessment of whether or not it is more likely than not that certain tax benefit positions will be sustained. The Company’s reserve for uncertain tax positions decreased by $2.4 million in the three months ended June 30, 2026, primarily due to the settlement of the China audit, partially offset by an increase in U.S. federal and state tax credits and incentives.
Current wording
As of September 30, 2026, the Company had gross unrecognized tax benefits of $28.1 million. Due to the uncertain and complex application of income tax regulations by certain tax authorities outside of the U.S., it is possible that the ultimate resolution of ongoing audits may result in liabilities that could be different from current estimates. The ongoing tax audits in various jurisdictions could impact future tax expense if tax authorities in their administration of tax laws during open audits may lead us to change our assessment of whether or not it is more likely than not that certain tax benefit positions will be sustained. The Company’s reserve for uncertain tax positions increased by $2.0 million in the three months ended September 30, 2026, primarily due to an increase in U.S. federal and state tax attributes.
Previous wording
Net income for the second quarter of 2026 improved over the prior-year period on both a GAAP and adjusted basis, primarily attributable to revenue growth and improved operating leverage.
Current wording
Net income for the third quarter of 2026 improved over the prior-year period on both a GAAP and adjusted basis, primarily attributable to revenue growth and improved operating leverage.
Previous wording
For the second quarter of 2026, basic and diluted earnings per share were both $0.16 per share and $2.12 and $2.05 per American Depositary Share (“ADS”), respectively, compared to $0.07 and $0.06 per share and $0.87 and $0.84 per ADS in the prior-year period. On an adjusted basis, basic and diluted earnings per share was $0.31 and $0.30 per share and $3.98 and $3.84 per ADS, respectively, compared to $0.18 and $0.17 per share and $2.33 and $2.25 per ADS in the prior-year period.
Current wording
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.
Previous wording
Total revenue increased to $3,218.5 million, or 32.3%, for the six months ended June 30, 2026, from $2,432.6 million for the six months ended June 30, 2025, primarily due to increased sales of our internally developed products, BRUKINSA and TEVIMBRA, as well as increased sales of in-licensed Amgen products.
Current wording
Total revenue increased to $5,108.3 million, or 32.9%, for the nine months ended September 30, 2026, from $3,844.9 million for the nine months ended September 30, 2025, primarily due to increased sales of our internally developed products, BRUKINSA and TEVIMBRA, as well as increased sales of in-licensed Amgen products.
Previous wording
Net product revenue increased 31.4% to $3,167.1 million for the six months ended June 30, 2026, compared to $2,410.6 million in the prior-year period, primarily due to increased sales of BRUKINSA globally, driven by continued growth in the U.S. and Europe. In addition, product revenues in the six months ended June 30, 2026 were positively impacted by sales of TEVIMBRA and in-licensed products from Amgen, primarily XGEVA®.
Current wording
Net product revenue increased 32.0% to $5,022.2 million for the nine months ended September 30, 2026, compared to $3,805.6 million in the prior-year period, primarily due to increased sales of BRUKINSA globally, driven by continued growth in the U.S. and Europe. In addition, product revenues in the nine months ended September 30, 2026 were positively impacted by sales of TEVIMBRA and in-licensed products from Amgen, primarily XGEVA®.
Previous wording
Global sales of BRUKINSA totaled $2,342.5 million in the six months ended June 30, 2026, representing a 34.5% increase compared to the prior-year period. U.S. sales of BRUKINSA totaled $1,653.6 million in the six months ended June 30, 2026, compared to $1,246.9 million in the prior-year period, representing growth of 32.6%, driven primarily by robust demand growth across all indications as well as favorable net pricing, of which approximately $20.0 million relates to non-recurring gross to net adjustments realized in the first quarter of 2026. BRUKINSA sales in Europe totaled $378.0 million in the six months ended June 30, 2026, representing growth of 41.9% driven by increased market share across all major European markets. BRUKINSA revenue in China totaled $191.2 million, representing growth of 16.3%. BRUKINSA rest of world revenue totaled $119.6 million in the six months ended June 30, 2026, representing growth of 87.3% compared to the prior-year period.
Current wording
Global sales of BRUKINSA totaled $3,733.4 million in the nine months ended September 30, 2026, representing a 34.2% increase compared to the prior-year period. U.S. sales of BRUKINSA totaled $2,658.7 million in the nine months ended September 30, 2026, compared to $1,985.6 million in the prior-year period, representing growth of 33.9%, driven primarily by demand growth across all indications as well as favorable net pricing, of which approximately $20.0 million relates to non-recurring gross to net adjustments realized in the first quarter of 2026. BRUKINSA sales in Europe totaled $595.6 million in the nine months ended September 30, 2026, representing growth of 38.6% driven by increased market share across all major European markets. BRUKINSA revenue in China totaled $294.3 million, representing growth of 14.6%. BRUKINSA rest of world revenue totaled $184.8 million in the nine months ended September 30, 2026, representing growth of 67.6% compared to the prior-year period.
Previous wording
Revenue for TEVIMBRA totaled $434.8 million in the six months ended June 30, 2026, compared to $364.7 million in the prior-year period, representing a 19.2% increase.
Current wording
Revenue for TEVIMBRA totaled $678.0 million in the nine months ended September 30, 2026, compared to $555.3 million in the prior-year period, representing a 22.1% increase.
Previous wording
Revenue for Amgen products in China totaled $299.5 million in the six months ended June 30, 2026, compared to $240.4 million in the prior-year period, driven primarily by increased XGEVA® sales volume.
Current wording
Revenue for Amgen products in China totaled $466.5 million in the nine months ended September 30, 2026, compared to $373.5 million in the prior-year period, driven primarily by increased XGEVA® sales volume.
Previous wording
Other revenue totaled $51.4 million and $22.0 million for the six months ended June 30, 2026 and 2025, respectively, primarily related to royalty revenue under the Amgen collaboration and revenue generated under the Novartis broad markets marketing and promotion agreement.
Current wording
Other revenue totaled $86.1 million and $39.2 million for the nine months ended September 30, 2026 and 2025, respectively, primarily related to royalty revenue under the Amgen collaboration and revenue generated under the Novartis broad markets marketing and promotion agreement.
Previous wording
Gross margin on product sales increased to $2,825.4 million for the six months ended June 30, 2026, compared to $2,081.0 million in the prior-year period, primarily due to increased product revenue in the current year period. Gross margin as a percentage of product sales increased to 89.2% for the six months ended June 30, 2026, from 86.3% in the comparable period of the prior year. 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 production productivity improvements for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 89.6%, from 86.9% in the comparable period of the prior year.
Current wording
Gross margin on product sales increased to $4,463.5 million for the nine months ended September 30, 2026, compared to $3,279.5 million in the prior-year period, primarily due to increased product revenue in the current year period. Gross margin as a percentage of product sales increased to 88.9% for the nine months ended September 30, 2026, from 86.2% in the comparable period of the prior year. 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 production productivity improvements for both BRUKINSA and TEVIMBRA, which was offset by a non-cash intangible asset impairment charge of $22.0 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 89.7%, from 86.7% in the comparable period of the prior year.
Previous wording
Research and development expense increased by $146.7 million, or 14.6%, to $1,153.5 million for the six months ended June 30, 2026 from $1,006.8 million for the six months ended June 30, 2025. The following table summarizes external clinical, external non-clinical and internal research and development expense for the six months ended June 30, 2026 and 2025, respectively:
Current wording
Research and development expense increased by $283.8 million, or 18.5%, to $1,814.3 million for the nine months ended September 30, 2026 from $1,530.4 million for the nine months ended September 30, 2025. The following table summarizes external clinical, external non-clinical and internal research and development expense for the nine months ended September 30, 2026 and 2025, respectively:
Previous wording
Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the six months ended June 30, 2026 totaled $117.9 million, of which $59.7 million was recorded as R&D expense. The remaining $58.2 million was recorded as a reduction of the R&D cost share liability.
Current wording
Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the nine months ended September 30, 2026 totaled $130.1 million, of which $65.7 million was recorded as R&D expense. The remaining $64.3 million was recorded as a reduction of the R&D cost share liability.
Previous wording
The increase in external research and development expenses in the six months ended June 30, 2026 was primarily attributable to an increase in development upfront and milestone fees and Amgen co-development expenses.
Current wording
The increase in external research and development expenses in the nine months ended September 30, 2026 was primarily attributable to increased investment in the continued advancement of several programs across the pipeline, including BTK CDAC, CDK4, PRMT5 and GPC3x4-1BB bsAb and an increase in development upfront and milestone fees, offset by a decrease in Amgen co-development expenses as we met the co-funding cap under the collaboration during the quarter ended September 30, 2026.
Previous wording
Internal research and development expense increased $111.9 million, or 18.4%, to $718.4 million and was primarily attributable to the expansion of our global development organization and our clinical and preclinical drug candidates, as well as our continued efforts to internalize research and clinical trial activities and control spend.
Current wording
Internal research and development expense increased by $215.8 million, or 23.3%, to $1,142.1 million and was primarily attributable to the expansion of our global development organization and our clinical and preclinical drug candidates, as well as our continued efforts to internalize research and clinical trial activities and control spend.
Previous wording
Selling, general and administrative expense increased by $151.1 million, or 15.2%, to $1,148.3 million, for the six months ended June 30, 2026, from $997.2 million for the six months ended June 30, 2025. The increase was primarily attributable to continued investment in global commercial expansion primarily in the U.S. and Europe. Selling, general and administrative expenses as a percentage of product sales were 36.3% for the six months ended June 30, 2026 compared to 41.4% in the prior-year period.
Current wording
Selling, general and administrative expense increased by $215.6 million, or 14.1%, to $1,741.8 million, for the nine months ended September 30, 2026, from $1,526.2 million for the nine months ended September 30, 2025. The increase was primarily attributable to continued investment in global commercial expansion primarily in the U.S. and Europe. Selling, general and administrative expenses as a percentage of product sales were 34.7% for the nine months ended September 30, 2026 compared to 40.1% in the prior-year period.
Previous wording
Interest income increased by $31.2 million, or 128.3%, to $55.6 million for the six months ended June 30, 2026, from $24.3 million for the six months ended June 30, 2025. The increase in interest income was primarily attributable to higher cash and cash equivalents balance.
Current wording
Interest income increased by $45.5 million, or 104.0%, to $89.2 million for the nine months ended September 30, 2026, from $43.7 million for the nine months ended September 30, 2025. The increase in interest income was primarily attributable to higher cash and cash equivalents balance.
Previous wording
Interest expense increased by $57.6 million, or 384.3%, to $72.6 million for the six months ended June 30, 2026, from $15.0 million for the six months ended June 30, 2025. Interest expense increased resulting from interest expense recorded under the effective interest method related to the sale of future royalty liability, higher interest rates on debt balances and lower interest capitalized related to completion of certain phases of our Hopewell facility.
Current wording
Interest expense increased by $83.7 million, or 266.8%, to $115.0 million for the nine months ended September 30, 2026, from $31.4 million for the nine months ended September 30, 2025. The increase in interest expense was primarily attributable to interest expense recorded under the effective interest method related to the sale of future royalty liability, higher interest rates on debt balances and lower interest capitalized related to completion of certain phases of our Hopewell facility.
Previous wording
Other income, net was $13.8 million for the six months ended June 30, 2026, primarily due to government subsidy income. For the six months ended June 30, 2025, other income, net was $12.1 million, primarily due to foreign exchange gains and government subsidy income, partially offset by unrealized losses on our equity investments.
Current wording
Other income, net was $14.2 million for the nine months ended September 30, 2026, primarily due to government subsidy income, offset by foreign exchange losses. For the nine months ended September 30, 2025, other expense, net was $6.9 million, primarily due to impairment losses recognized on our equity investments, partially offset by government subsidy income and foreign exchange gains.
Previous wording
Income tax expense increased to $107.3 million for the six months ended June 30, 2026, from $24.9 million for the six months ended June 30, 2025. The income tax expense for the six months ended June 30, 2026 and 2025 was primarily attributable to the application of our expected current worldwide effective tax rate for the fully year to year-to-date actual pre-tax income, reflecting the mix of taxable income across jurisdictions as well as the impact of certain discrete items. Specifically, the provision for income taxes for the six months ended June 30, 2026 included a discrete net tax expense of approximately $52.8 million. This figure primarily relates to the settlement of the audit of one of our China subsidiaries amounting to $59.6 million, partially offset by certain discrete items mainly related to U.S. share-based compensation. The income tax expense for the six months ended June 30, 2025 included a discrete net tax benefit of $8.7 million, primarily related to updated provision estimates for U.S. R&D tax credits.
Current wording
Income tax expense increased to $133.0 million for the nine months ended September 30, 2026, from $47.2 million for the nine months ended September 30, 2025. The income tax expense for the nine months ended September 30, 2026 and 2025 was primarily attributable to the application of our expected current worldwide effective tax rate for the full year to year-to-date actual pre-tax income, reflecting the mix of taxable income across jurisdictions as well as the impact of certain discrete items. Specifically, the provision for income taxes for the nine months ended September 30, 2026 included a discrete net tax expense of approximately $41.3 million. This figure primarily relates to the settlement of the audit of one of our China subsidiaries amounting to $59.6 million, partially offset by certain discrete items mainly related to U.S. share-based compensation. The income tax expense for the nine months ended September 30, 2025 included a discrete net tax benefit of $9.6 million, primarily related to updated provision estimates for U.S. R&D tax credits.
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