BIOGEN INC.
For the period ended Sep 30, 2025. Filed Oct 30, 2025.
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, 2025 · Filed Oct 30, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-07-31.
0000875045-25-000033
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-10-30.
0000875045-25-000049
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 399 previous paragraphs and 413 current paragraphs.
256 unchanged; 109 reworded; 41 added; 25 removed; 9 previous and 7 current paragraphs rearranged.
Tables are not compared: 12 previous and 12 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 (41)
Current report
For additional information, please read Note 21, Litigation, to our condensed consolidated financial statements included in this report.
Current report
$68.9 million or 2.8%
Current report
$0.51 or 19.2%
Current report
$77.5 million or 4.4%
Current report
•MS revenue increased $7.6 million, or 0.7%
Current report
•Rare disease revenue increased $38.5 million, or 7.8%
Current report
•ZURZUVAE revenue of $55.3 million in the third quarter of 2025 was driven by the continued launch in the U.S.
Current report
$37.4 million or 1.9%
Current report
•Cost of sales increased $35.7 million, or 5.6%
Current report
•The increase in cost of sales was primarily due to a charge recorded during the third quarter of 2025 of approximately $104.3 million related to a litigation matter and higher SKYCLARYS inventory step-up amortization costs, partially offset by lower cost of contract manufacturing revenue driven by the timing of batch releases and lower inventory write-offs during the third quarter of 2025.
Current report
2025 ACQUISITIONS, COLLABORATIVE AND OTHER RELATIONSHIPS
Current report
ALCYONE THERAPEUTICS, INC.
Current report
In September 2025 we entered into a definitive agreement to acquire all of the issued and outstanding shares of Alcyone Therapeutics, Inc., a clinical-stage biotechnology company focused on pediatric care through precision CNS therapeutics and dosing platforms. Alcyone's lead asset is ThecaFlex DRx, an implantable subcutaneous port and catheter device being investigated for the intrathecal delivery of ASOs, which is designed to provide an alternative to repeat lumbar punctures in chronic intrathecal administration of medicines.
Current report
We have agreed to pay an upfront cash payment of $85.0 million upon closing, plus additional potential amounts payable upon the achievement of certain milestones related to the development and regulatory approval of ThecaFlex DRx for administering SPINRAZA and additional pipeline products.
Current report
We plan to account for this proposed acquisition as an asset acquisition as the value being acquired primarily relates to a single asset and plan to record the upfront payment within acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income upon the completion of this proposed acquisition. We anticipate the proposed acquisition to close during the fourth quarter of 2025, subject to the satisfaction of customary closing conditions. Under the terms of this proposed acquisition, we expect to oversee the end-to-end development, manufacturing and commercialization of ThecaFlex DRx.
Current report
Alcyone's remaining therapeutic assets would be divested from Alcyone into Neela Therapeutics, Inc., a newly formed independent company, prior to the closing of this proposed acquisition. We anticipate to make a convertible debt investment of up to$5.0 million in Neela Therapeutics. Inc.
Current report
For additional information on our proposed acquisition of Alcyone, please read Note 2, Acquisitions, to our condensed consolidated financial statements included in this report.
Current report
•In September 2025 the Therapeutic Goods Administration of Australia approved LEQEMBI for adults who are either apolipoprotein E ε4 non-carriers or heterozygous carriers.
Current report
•In September 2025 the EC approved ZURZUVAE in the E.U. for the treatment of PPD in adults following childbirth, offering the first and only treatment indicated for PPD in the E.U.
Current report
•In August 2025 the Medicines and Healthcare products Regulatory Agency in the U.K. granted marketing authorization for ZURZUVAE for moderate to severe PPD in the U.K.
Current report
•In September 2025 the FDA issued a CRL for the supplemental NDA for a higher dose regimen of nusinersen for the treatment of SMA. The CRL requested an update to the technical information to be included in the Chemistry Manufacturing and Controls module of the supplemental NDA and did not cite any deficiencies in the clinical data of the high dose regimen. The CRL provided options for resolution and we have announced a plan to resubmit the application promptly based upon readily available information.
Current report
For additional information on our sale of TOFIDENCE, please read Note 3, Dispositions, to our condensed consolidated financial statements included in this report.
Current report
•Global VUMERITY revenue increased $56.5 million, from $158.1 million in 2024 to $214.6 million in 2025, or 35.7%, primarily due to an increase in U.S. VUMERITY driven by higher demand, timing of shipments and favorable pricing dynamics, as well as a favorable change in estimate of approximately $13.0 million related to rebates and discounts in the U.S.
Current report
•Global TYSABRI revenue increased $25.7 million, from $406.1 million in 2024 to $431.8 million in 2025, or 6.3%, primarily due to higher net pricing in the U.S. and a favorable change in estimate related to rebates and discounts in the U.S., partially offset by a decrease in global TYSABRI demand due to increased competition, including the impacts from a biosimilar entrant of TYSABRI in Europe.
Current report
•Global Interferon revenue increased $9.4 million, from $237.5 million in 2024 to $246.9 million in 2025, or 4.0%, primarily due to a favorable change in estimate of approximately $18.0 million related to rebates and discounts. This increase was partially offset by a decrease in rest of world Interferon revenue as patients continue to transition to higher efficacy therapies.
Current report
For the three months ended September 30, 2025, compared to the same period in 2024, the decrease in contract manufacturing revenue was primarily due to lower manufacturing batch releases during the third quarter of 2025 driven by the acceleration of timing for manufacturing batch releases during the first half of 2025, as discussed below.
Current report
For the three months ended September 30, 2025, compared to the same period in 2024, the decrease in product cost of sales was primarily due to lower cost of contract manufacturing revenue driven by the timing of batch releases and lower inventory write-offs, partially offset by higher SKYCLARYS inventory step-up amortization costs.
Current report
For the three andnine months ended September 30, 2025, compared to the same periods in 2024, the increases in royalty cost of sales were primarily due to a charge recorded during the third quarter of 2025 of approximately $104.3 million related to a litigation matter. For additional information on our litigation matters, please read Note 21, Litigation, to our condensed consolidated financial statements included in this report.
Current report
•advancement of felzartamab for AMR, IgAN and PMN to late stage.
Current report
•development of salanersen for the treatment of SMA
Current report
•increased spend on SKYCLARYS for the treatment of pediatric FA.
Current report
•development of salanersen for the treatment of SMA;
Current report
•development of felzartamab for IgAN and PMN prior to advancement to late stage; and
Current report
•development of felzartamab for lupus nephritis.
Current report
•$48.5 million of step-up amortization related to SKYCLARYS inventory recorded in the prior year comparative period.
Current report
For additional information on our collaboration and license arrangements with Samsung Bioepis and Supernus, please read Note 19, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.
Current report
During the second quarter of 2025 the first milestone related to the fourth patient dosed in a phase 3 clinical trial of felzartamab for AMR was achieved, resulting in a $150.0 million milestone payment made to the former shareholders of HI-Bio, which was paid during the third quarter of 2025. In October 2025 the second milestone related to the fourth patient dosed in a phase 3 clinical trial of felzartamab for IgAN was achieved, resulting in a $150.0 million milestone payment to be made to the former shareholders of HI-Bio, which we expect will be paid during the fourth quarter of 2025.
Current report
For the nine months ended September 30, 2025, compared to the same period in 2024, the change in other (income) expense, net primarily reflects higher interest income in 2025 driven by higher cash balances.
Current report
For the three and nine months ended September 30, 2024, our effective tax rates benefited from a decrease in our valuation allowance, partially offset by the impact of certain foreign uncertain tax positions.
Current report
During the second quarter of 2025 the first milestone related to the fourth patient dosed in a phase 3 clinical trial of felzartamab for AMR was achieved, resulting in a $150.0 million milestone payment made to the former shareholders of HI-Bio, which was paid during the third quarter of 2025. In October 2025 the second milestone related to the fourth patient dosed in a phase 3 clinical trial of felzartamab for IgAN was achieved, resulting in a $150.0 million milestone payment to be made to the former shareholders of HI-Bio, which we expect will be paid during the fourth quarter of 2025.
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Removed paragraphs (25)
Previous report
$180.6 million or 7.3%
Previous report
$0.33 or 8.3%
Previous report
$20.9 million or 1.1%
Previous report
•MS revenue decreased $42.6 million, or 3.7%
Previous report
•Rare disease revenue increased $8.9 million, or 1.7%
Previous report
$135.3 million or 7.7%
Previous report
•Cost of sales increased $59.0 million, or 10.8%
Previous report
•Acquired IPR&D, upfront and milestone expense increased $38.1 million
Previous report
•The increase in acquired IPR&D, upfront and milestone expense was primarily due to an upfront payment of $16.0 million to City Therapeutics in connection with the closing of our strategic research arrangement, as well as a $30.0 million milestone accrued during the second quarter of 2025 in connection with the first patient dosed in a Phase 3 clinical trial of felzartamab for the treatment of IgAN.
Previous report
COLLABORATIVE AND OTHER RELATIONSHIPS
Previous report
•In March 2025 we and Eisai announced that the Therapeutic Goods Administration of Australia confirmed the initial decision made in October 2024 to decline the approval of lecanemab as a treatment for early Alzheimer's disease.
Previous report
In July 2025 the CHMP of the EMA adopted a positive opinion recommending the marketing authorization for zuranolone for the treatment of PPD.
Previous report
•Global TYSABRI revenue decreased $57.4 million, from $893.5 million in 2024 to $836.1 million in 2025, or 6.4%, primarily due to a decrease in demand and pricing in rest of world TYSABRI, offset in part by favorable net pricing in the U.S.
Previous report
•Global VUMERITY revenue increased $57.8 million, from $293.3 million in 2024 to $351.1 million in 2025, or 19.7%, primarily due to favorable commercial mix and a favorable change in estimate during the second quarter of 2025 of approximately $22.0 million related to rebates and discounts, partially offset by charges related to the IRA.
Previous report
For the three months ended June 30, 2025, compared to the same period in 2024, the increase in royalty cost of sales was primarily due to higher royalties payable associated with higher sales of VUMERITY.
Previous report
For the six months ended June 30, 2025, compared to the same period in 2024, the increase in royalty cost of sales was primarily due to higher royalties payable associated with higher sales of VUMERITY and SPINRAZA, partially offset by lower royalties payable associated with lower sales of TYSABRI.
Previous report
•development of zorevunersen for the treatment of Dravet syndrome.
Previous report
•$46.0 million of step-up amortization related to SKYCLARYS inventory recorded in the second quarter of 2024; and
Previous report
•development of felzartamab for IgAN, PMN and Lupus Nephritis;
Previous report
•development of zorevunersen for the treatment of Dravet syndrome.
Previous report
•$46.0 million of step-up amortization related to SKYCLARYS inventory recorded in the second quarter of 2024; and
Previous report
For additional information on our collaboration and license arrangements with Samsung Bioepis and Sage, please read Note 19, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.
Previous report
During the second quarter of 2025 the first milestone related to the fourth patient dosed in a phase 3 clinical trial of felzartamab for AMR was achieved, resulting in a $150.0 million milestone payment made to the former shareholders of HI-Bio, which was substantially paid in July 2025.
Previous report
During the second quarter of 2025 the first milestone related to the fourth patient dosed in a phase 3 clinical trial of felzartamab for AMR was achieved, resulting in a $150.0 million milestone payment made to the former shareholders of HI-Bio, which was substantially paid in July 2025. We expect to achieve the second milestone payment of $150.0 million related to the fourth patient dosed in a phase 3 clinical trial of felzartamab for IgAN during the third quarter of 2025.
Previous report
During the second quarter of 2025 the first milestone related to the fourth patient dosed in a phase 3 clinical trial of felzartamab for AMR was achieved, resulting in a $150.0 million milestone payment made to the former shareholders of HI-Bio, which was substantially paid in July 2025. We expect to achieve the second milestone payment of $150.0 million related to the fourth patient dosed in a phase 3 clinical trial of felzartamab for IgAN during the third quarter of 2025.
Reworded paragraphs (109)
Previous wording
We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the commercialization of ZURZUVAE for the treatment of PPD. We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of relapsed or refractory follicular lymphoma; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma; and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group.
Current wording
We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Supernus on the commercialization of ZURZUVAE for the treatment of PPD. We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL, follicular lymphoma and, following its approval in October 2025, lupus nephritis; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of relapsed or refractory follicular lymphoma; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma; and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group.
Previous wording
Our products and revenue streams continue to face increasing competition in many markets from the introduction of new originator therapies, generics, biosimilars of existing products and products approved under abbreviated regulatory pathways. Some of these products are likely to be sold at substantially lower prices than branded products. Accordingly, the introduction of such products as well as other lower-priced competing products may significantly reduce both the price that we are able to charge for our products and the volume of products we sell, which will negatively impact our revenue. In addition, in some markets, when a generic or biosimilar version of one of our products is commercialized, it may be automatically substituted for our product and significantly reduce our revenue in a short period of time.
Current wording
Our products and revenue streams continue to face increasing competition in many markets from the introduction of new originator therapies, generics, biosimilars of existing products and products approved under abbreviated regulatory pathways. Some of these products are likely to be sold at substantially lower prices than branded products. Accordingly, the introduction of such products as well as other lower-priced competing products has, and in the future, may significantly reduce both the price that we are able to charge for our products and the volume of products we sell, which can negatively impact our revenue. In addition, in some markets, when a generic or biosimilar version of one of our products is commercialized, it may be automatically substituted for our product and significantly reduce our revenue in a short period of time.
Previous wording
Drug prices are under significant scrutiny in the markets in which our products are prescribed; for example the IRA has certain provisions related to drug pricing, including the ability for the U.S. government to set prices for certain drugs in Medicare. We expect drug pricing and other health care costs will continue to be subject to political and societal pressures on a global basis. Additionally, our ability to set the price for our products varies significantly from country to country and, as a result, so can the price or reimbursement of our products. Governments may use a variety of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, value-based pricing and reference pricing (i.e., referencing prices in other countries and using those reference prices to set a price).
Current wording
Additionally, our ability to set the price for our products varies significantly from country to country and, as a result, so can the price or reimbursement of our products. Governments may use a variety of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, value-based pricing and reference pricing (i.e., referencing prices in other countries and using those reference prices to set a price).
Previous wording
Multiple TECFIDERA generic entrants are now in North America, Brazil and certain European countries and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and we expect that TECFIDERA revenue will continue to decline. We are defending the validity of our EP 2 653 873 patent related to TECFIDERA which expires in 2028 in opposition proceedings in the European Patent Office. We are also engaged in litigation in Europe to defend and enforce national counterparts of our EP 2 653 873 patent, with mixed results as we have been unsuccessful in enjoining generic entry in several significant European markets.
Current wording
Multiple TECFIDERA generic entrants are now in North America, Brazil and certain European countries and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and we expect that TECFIDERA revenue will continue to decline. We are defending the validity of our EP 2 653 873 patent related to TECFIDERA which expires in 2028 in opposition proceedings before the Technical Boards of Appeal of the European Patent Office in November 2025. We are also engaged in litigation in Europe to defend and enforce national counterparts of our EP 2 653 873 patent, with mixed results as we have been unsuccessful in enjoining generic entry in several significant European markets.
Previous wording
BUSINESS UPDATE REGARDING MACROECONOMIC CONDITIONS AND OTHER DISRUPTIONS
Current wording
BUSINESS UPDATE REGARDING MACROECONOMIC CONDITIONS AND OTHER POTENTIAL DISRUPTIONS
Previous wording
We have significant manufacturing presence in the U.S. While our portfolio is evolving, approximately three quarters of our 2024 U.S. product revenue comes from products that are primarily manufactured domestically. However, we, and the pharmaceutical industry, do utilize partners and production facilities located outside the U.S. for certain raw materials, ingredients, processes and components for our pharmaceutical products and their delivery devices. Engaging alternative suppliers may involve seeking additional regulatory approvals and incurring additional costs and risks associated with new suppliers. This may be costly in terms of time and resources needed or result in delays.
Current wording
We have significant manufacturing presence in the U.S. While our portfolio is evolving, approximately three quarters of our 2024 U.S. product revenue was attributable to products which were largely manufactured in the U.S. However, we, and the pharmaceutical industry, do utilize partners and production facilities located outside the U.S. for certain raw materials, ingredients, processes and components for our pharmaceutical products and their delivery devices. Engaging alternative suppliers may involve seeking additional regulatory approvals and incurring additional costs and risks associated with new suppliers. This may be costly in terms of time and resources needed or result in delays.
Previous wording
We currently do not expect a material impact in 2025 from potential tariffs as previously announced by the U.S. Administration on April 2, 2025, even if the exemption for pharmaceuticals were to be removed. This is based on the expected timing of any potential tariffs, our manufacturing footprint, and our inventory levels and positioning, although the actual impact of tariffs on our business and financial condition may differ materially from our current expectations. We will continue to monitor the current and future global tariff landscape as it evolves.
Current wording
We currently do not expect a material impact in 2025 from potential tariffs as previously announced by the U.S. Administration during 2025, even if the exemption for pharmaceuticals were to be removed. This is based on the expected timing of any potential tariffs, our manufacturing footprint, and our inventory levels and positioning, although the actual impact of tariffs on our business and financial condition may differ materially from our current expectations. We will continue to monitor the current and future global tariff landscape as it evolves.
Previous wording
We will continue to monitor the ongoing conflict between Russia and Ukraine as well as the military conflict in the Middle East and assess any potential impacts on our business, supply chain, partners or customers, as well as any factors that could have an adverse effect on our results of operations. Revenue generated from sales in Russia and Ukraine represent less than 1.0% of total revenue for the three and six months ended June 30, 2025 and 2024. Additionally, revenue generated from sales in the Middle East region represents less than 2.0% of total revenue for the three and six months ended June 30, 2025 and 2024.
Current wording
We will continue to monitor the ongoing conflict between Russia and Ukraine as well as the military conflict in the Middle East and assess any potential impacts on our business, supply chain, partners or customers, as well as any factors that could have an adverse effect on our results of operations. Revenue generated from sales in Russia and Ukraine represent less than 1.0% of total revenue for the three and nine months ended September 30, 2025 and 2024. Additionally, revenue generated from sales in the Middle East region represents less than 2.0% of total revenue for the three and nine months ended September 30, 2025 and 2024.
Previous wording
In August 2022 the IRA was signed into law in the U.S. The IRA introduced new tax provisions, including a 15.0% corporate alternative minimum tax and a 1.0% excise tax on stock repurchases. The provisions of the IRA are effective for periods after December 31, 2022. The IRA did not result in any material adjustments to our income tax provision for the three and six months ended June 30, 2025 and 2024. Preliminary guidance has been issued by the IRS and we expect additional guidance and regulations to be issued in future periods. We continue to assess its potential impact on our business and results of operations as further information becomes available.
Current wording
In August 2022 the IRA was signed into law in the U.S. The IRA introduced new tax provisions, including a 15.0% corporate alternative minimum tax and a 1.0% excise tax on stock repurchases. The provisions of the IRA are effective for periods after December 31, 2022. The IRA did not result in any material adjustments to our income tax provision for the three and nine months ended September 30, 2025 and 2024. Preliminary guidance has been issued by the IRS and we expect additional guidance and regulations to be issued in future periods. We continue to assess its potential impact on our business and results of operations as further information becomes available.
Previous wording
Based on our initial assessment of the OBBBA, we do not expect the introduced tax changes to have a material impact on our consolidated financial statements in 2025. However, given the complexity of tax laws, related regulations and interpretations, our current estimates may require revision as additional information becomes available regarding the application of the OBBBA provisions.
Current wording
The OBBBA did not result in any material adjustments to our total income tax provision for the three and nine months ended September 30, 2025, and we have adjusted our deferred tax balances to reflect the impacts of the OBBBA enactment. However, given the complexity of tax laws, related regulations and interpretations, our current estimates may require revision as additional information becomes available regarding the application of the OBBBA provisions.
Previous wording
•The decrease in MS product revenue was primarily due to a decrease in global TECFIDERA and TYSABRI demand due to increased competition outside the U.S. from generic and biosimilar competition, respectively. These factors were offset in part by an increase in demand for U.S. VUMERITY and favorable U.S. TYSABRI inventory dynamics. MS product revenue in the U.S. also benefited from favorable commercial mix and approximately $45.0 million of favorable changes in estimates resulting in lower discounts and allowances.
Current wording
•The increase in MS product revenue was primarily due to an increase in U.S. VUMERITY driven by higher demand, timing of shipments and favorable pricing dynamics, partially offset by a decrease in global TECFIDERA demand due to increased competition outside the U.S. from generic competition. MS product revenue in the U.S. also benefited from favorable commercial mix and approximately $38.0 million of favorable changes in estimates from discounts and allowances.
Previous wording
•The increase in rare disease product revenue was primarily due to our new product launches, including global SKYCLARYS revenue of $130.3 million and global QALSODY revenue of $20.0 million in the second quarter of 2025.
Current wording
•The increase in rare disease product revenue was primarily due to our new product launches, including global SKYCLARYS revenue of $132.9 million and global QALSODY revenue of $26.4 million in the third quarter of 2025.
Previous wording
•R&D expense decreased $106.4 million, or 21.1%
Current wording
•R&D expense decreased $80.1 million, or 15.5%
Previous wording
•SG&A expense increased $30.0 million, or 5.4%
Current wording
•SG&A expense increased $6.4 million, or 1.1%
Previous wording
•The increase in SG&A expense was primarily due to an increase in operational spending on sales and marketing activities in support of LEQEMBI and SKYCLARYS as we continue to expand our U.S. and international product launches.
Current wording
•The increase in SG&A expense was primarily due to increases in operational spending on sales and marketing activities in support of LEQEMBI and SKYCLARYS as we continue to expand our U.S. and international product launches.
Previous wording
•Cash and cash equivalents totaled approximately $2.8 billion as of June 30, 2025, compared to approximately $2.4 billion as of December 31, 2024.
Current wording
•Cash, cash equivalents and marketable securities totaled approximately $4.0 billion as of September 30, 2025, compared to approximately $2.4 billion as of December 31, 2024.
Previous wording
•We generated approximately $420.2 million of net cash flow from operations for the six months ended June 30, 2025, compared to approximately $1,179.0 million in the prior year comparative period.
Current wording
•We generated approximately $1.7 billion of net cash flow from operations for the nine months ended September 30, 2025, compared to approximately $2.1 billion in the prior year comparative period.
Previous wording
•This year-over-year reduction was due in part to higher worldwide tax payments in 2025, compared to 2024, of approximately $774.7 million due to the timing of estimated payments.
Current wording
•The year-over-year reduction in net cash flow from operations was due in part to higher worldwide tax payments in 2025 of approximately $840.7 million driven by the timing of estimated payments.
Previous wording
In May 2025 we entered into a strategic research arrangement with City Therapeutics to develop select novel RNAi therapies. Through this arrangement, City Therapeutics will leverage its next-generation RNAi engineering technologies to develop an RNAi trigger molecule combined with our proprietary drug delivery technology. The collaboration will initially focus on a single target that mediates key central nervous system diseases, utilizing tissue enhanced delivery technologies with the aim of allowing for systemic administration of medicines. We will be responsible for IND-enabling studies and global clinical development along with any regulatory submissions and all activities related to commercialization.
Current wording
In May 2025 we entered into a strategic research arrangement with City Therapeutics to develop select novel RNAi therapies. Through this arrangement, City Therapeutics will leverage its next-generation RNAi engineering technologies to develop an RNAi trigger molecule combined with our proprietary drug delivery technology. The collaboration will initially focus on a single target that mediates key CNS diseases, utilizing tissue enhanced delivery technologies with the aim of allowing for systemic administration of medicines. We will be responsible for IND-enabling studies and global clinical development along with any regulatory submissions and all activities related to commercialization.
Previous wording
In connection with the closing of this transaction we made an upfront payment of $16.0 million to City Therapeutics, which was recognized as acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for thethree and six months ended June 30, 2025, and invested $30.0 million in exchange for a City Therapeutics convertible note, representing a minority equity interest in City Therapeutics, if converted. This convertible note was recorded as a component of investments and other assets within our condensed consolidated balance sheets as of June 30, 2025.
Current wording
In connection with the closing of this transaction we made an upfront payment of $16.0 million to City Therapeutics, which was recognized as acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for thenine months ended September 30, 2025, and invested $30.0 million in exchange for a City Therapeutics convertible note, representing a minority equity interest in City Therapeutics, if converted. This convertible note was recorded as a component of investments and other assets within our condensed consolidated balance sheets as of September 30, 2025.
Previous wording
In February 2025 we entered into a collaboration and license agreement with Stoke to co-develop and commercialize zorevunersen, an investigational ASO that targets the SCN1A gene for the potential treatment of Dravet syndrome, a rare form of genetic epilepsy associated with refractory seizures and neurodevelopmental impairments. Zorevunersen is a Phase 3-ready disease modifying asset on track to start dosing in a global Phase 3 registrational study in the third quarter of 2025. Under the terms of this agreement, Stoke will continue to lead global development and retain exclusive development and commercialization rights for zorevunersen in the U.S., Canada and Mexico and we will have exclusive rights to commercialize zorevunersen in the rest of the world.
Current wording
In February 2025 we entered into a collaboration and license agreement with Stoke to co-develop and commercialize zorevunersen, an investigational ASO that targets the SCN1A gene for the potential treatment of Dravet syndrome, a rare form of genetic epilepsy associated with refractory seizures and neurodevelopmental impairments. Zorevunersen dosed its first patient in August 2025, advancing zorevunersen to a global Phase 3 trial. Under the terms of this agreement, Stoke will continue to lead global development and retain exclusive development and commercialization rights for zorevunersen in the U.S., Canada and Mexico and we will have exclusive rights to commercialize zorevunersen in the rest of the world.
Previous wording
In connection with the closing of this transaction we made an upfront payment of $165.0 million to Stoke, which was recognized as acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for the six months ended June 30, 2025.
Current wording
In connection with the closing of this transaction we made an upfront payment of $165.0 million to Stoke, which was recognized as acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for the nine months ended September 30, 2025.
Previous wording
In February 2025 we entered into a funding agreement with Royalty Pharma under which we will receive up to $200.0 million in 2025 and up to $50.0 million in 2026 to co-fund our development costs for the litifilimab program. As there is a substantive transfer of risk to the financial partner for the amount invested, the development funding will be recognized by us as an obligation to perform contractual services. We plan to recognize this funding as a reduction to research and development expense within our condensed consolidated statements of income, proportionate to the related expense. For thethree and six months ended June 30, 2025, we recorded reductions to research and development expense of $50.0 million and $100.0 million, respectively, within our condensed consolidated statements of income.
Current wording
In February 2025 we entered into a funding agreement with Royalty Pharma under which we will receive up to $200.0 million in 2025 and up to $50.0 million in 2026 to co-fund our development costs for the litifilimab program. As there is a substantive transfer of risk to the financial partner for the amount invested, the development funding will be recognized by us as an obligation to perform contractual services. We plan to recognize this funding as a reduction to research and development expense within our condensed consolidated statements of income, proportionate to the related expense. For thethree and nine months ended September 30, 2025, we recorded reductions to research and development expense of $50.0 million and $150.0 million, respectively, within our condensed consolidated statements of income.
Previous wording
•In January 2025 the FDA accepted for review the BLA for LEQEMBI subcutaneous autoinjector for weekly maintenance dosing, with a PDUFA action date set for August 31, 2025.
Current wording
•In August 2025 the FDA approved the BLA for LEQEMBI subcutaneous autoinjector (IQLIK) for weekly maintenance dosing.
Previous wording
In June 2025 we announced positive topline results from the Phase 1b study of salanersen, an ASO being developed for the treatment of SMA. Interim Phase 1b data shows children with SMA previously treated with gene therapy experienced a substantial slowing of neurodegeneration and clinically meaningful improvements in motor function following initiation of salanersen. We are currently engaging with regulators to advance salanersen to a Phase 3 registrational study.
Current wording
•In June 2025 we announced positive topline results from the Phase 1b study of salanersen, an ASO being developed for the treatment of SMA. Interim Phase 1b data shows children with SMA previously treated with gene therapy experienced a substantial slowing of neurodegeneration and clinically meaningful improvements in motor function following initiation of salanersen. We are currently engaging with regulators about the possibility of advancing salanersen to a Phase 3 registrational study.
Previous wording
In January 2025 the FDA accepted the supplemental NDA and the EMA validated the application for a higher dose regimen of nusinersen for SMA. The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg-doses 14 days apart, and higher maintenance regimen, 28 mg, every four months, compared to the currently approved dose of SPINRAZA.
Current wording
•In January 2025 the FDA accepted for review the supplemental NDA and the EMA validated the application for a higher dose regimen of nusinersen for SMA. The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg-doses 14 days apart, and higher maintenance regimen, 28 mg, every four months, compared to the currently approved dose of SPINRAZA.
Previous wording
In March 2025 we completed the sale of our regulatory and commercial rights in the U.S. for TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA, to Organon. Under the terms of this transaction, we received a payment of approximately $51.0 millionin July 2025 and recognized a de minimis loss within our condensed consolidated statements of income for the six months ended June 30, 2025.
Current wording
In March 2025 we completed the sale of our regulatory and commercial rights in the U.S. for TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA, to Organon. Under the terms of this transaction, we received a payment of approximately $51.0 millionin July 2025 and recognized a de minimis loss within our condensed consolidated statements of income for the nine months ended September 30, 2025.
Previous wording
In March 2025 we entered into a lease agreement with MIT Investment Management Company and BioMed Realty for the lease of approximately 580,000 square feet of office and research and development space located at 75 Broadway, Cambridge, Massachusetts, which will be used as our new global corporate headquarters, as well as integrating our research and development and technical operations teams alongside our North American commercial organization. As part of a multi-year real estate consolidation plan that is expected to result in a reduction of approximately 40% in our real estate footprint in Massachusetts, this new lease is intended to replace two existing leases, both in Cambridge, Massachusetts, including our current corporate headquarters. We expect the initial lease term of approximately 15.5 years to commence on May 31, 2028.
Current wording
In March 2025 we entered into a lease agreement with MIT Investment Management Company and BioMed Realty for the lease of approximately 580,000 square feet of office and research and development space located at 75 Broadway, Cambridge, Massachusetts, which will be used as our new global corporate headquarters, as well as integrating our research and development and technical operations teams alongside our North American commercial organization. As part of a multi-year real estate consolidation plan that is expected to result in a reduction of approximately 40% of our real estate footprint in Massachusetts, this new lease is intended to replace two existing leases, both in Cambridge, Massachusetts, including our current corporate headquarters. We expect the initial lease term of approximately 15.5 years to commence on May 31, 2028.
Previous wording
•Global TECFIDERA revenue decreased $58.6 million, from $252.2 million in 2024 to $193.6 million in 2025, or 23.2%, driven by a decrease in demand resulting from multiple TECFIDERA generic entrants.
Current wording
•Global TECFIDERA revenue decreased $64.6 million, from $232.8 million in 2024 to $168.2 million in 2025, or 27.7%, driven by a decrease in demand resulting from multiple TECFIDERA generic entrants.
Previous wording
•Global VUMERITY revenue increased $46.5 million, from $165.8 million in 2024 to $212.3 million in 2025, or 28.0%, primarily due to favorable commercial mix and a favorable change in estimate of approximately $22.0 million related to rebates and discounts, partially offset by charges related to the IRA.
Current wording
•Global VUMERITY revenue increased $114.3 million, from $451.4 million in 2024 to $565.7 million in 2025, or 25.3%, primarily due to an increase in U.S. VUMERITY driven by higher demand and a favorable change in estimate of approximately $40.0 million related to rebates and discounts in the U.S., partially offset by charges related to the IRA redesign.
Previous wording
•Global TYSABRI revenue decreased $7.6 million, from $462.2 million in 2024 to $454.6 million in 2025, or 1.6%, primarily due to increased competition, including the impacts from a biosimilar entrant of TYSABRI in Europe. The decrease was partially offset by an increase in U.S. TYSABRI driven by a favorable change in estimate of approximately $12.0 million related to rebates and discounts and favorable inventory dynamics.
Current wording
•Global TYSABRI revenue decreased $31.7 million, from $1,299.6 million in 2024 to $1,267.9 million in 2025, or 2.4%, primarily due to increased competition in rest of world, including the impacts from a biosimilar entrant of TYSABRI in Europe. The decrease was partially offset by a favorable change in estimate of approximately $16.0 million related to rebates and discounts and favorable inventory dynamics in the U.S.
Previous wording
•Global Interferon revenue decreased $4.2 million, from $250.9 million in 2024 to $246.7 million in 2025, or 1.7%, as patients continue to transition to higher efficacy therapies. This decline is partially offset by favorable inventory dynamics in the U.S.
Current wording
•Global Interferon revenue decreased $12.1 million, from $732.0 million in 2024 to $719.9 million in 2025, or 1.7%, driven by a decrease in demand as patients transition to higher efficacy therapies, offset in part by a favorable change in estimate of approximately $32.0 million related to rebates and discounts in the U.S.
Previous wording
•Global TECFIDERA revenue decreased $106.8 million, from $506.5 million in 2024 to $399.7 million in 2025, or 21.1%, driven by a decrease in demand as a result of multiple TECFIDERA generic entrants.
Current wording
•Global TECFIDERA revenue decreased $171.4 million, from $739.3 million in 2024 to $567.9 million in 2025, or 23.2%, driven by a decrease in demand as a result of multiple TECFIDERA generic entrants.
Previous wording
MS revenue includes sales from TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated. We expect to recognize minimal revenue in 2025.
Current wording
MS revenue includes sales from TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated and we expect to recognize minimal revenue in 2025.
Previous wording
In 2025 we expect total MS revenue will continue to decline as a result of increasing competition for many of our MS products in both the U.S. and rest of world markets.
Current wording
In 2025 we expect total MS revenue will continue to decline as a result of increasing competition for many of our MS products in both the U.S. and rest of world markets. We expect TECFIDERA revenue will be adversely impacted by accelerating generic competition in certain markets in the E.U. for at least the remainder of the year. Additionally, a biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We expect that future sales of TYSABRI will continue to be adversely affected by the entrance of this biosimilar in certain international markets.
Previous wording
•U.S. SPINRAZA revenue decreased $8.0 million, from $157.3 million in 2024 to $149.3 million in 2025, or 5.1%, primarily due to lower demand.
Current wording
•U.S. SPINRAZA revenue increased $0.1 million, from $153.1 million in 2024 to $153.2 million in 2025, or 0.1%.
Previous wording
•Rest of world SPINRAZA revenue decreased $28.4 million, from $271.8 million in 2024 to $243.4 million in 2025, or 10.4%, partially due to lower demand, timing of shipments and the unfavorable impact of foreign currency exchange.
Current wording
•Rest of world SPINRAZA revenue decreased $7.5 million, from $228.3 million in 2024 to $220.8 million in 2025, or 3.3%, partially due to lower demand and pricing adjustments during the third quarter of 2025, partially offset by the favorable impact of foreign currency exchange.
Previous wording
•Global SKYCLARYS revenue increased $76.2 million, from $178.0 million in 2024 to $254.2 million in 2025, or 42.8%, primarily related to primarily related to an increase in rest of world sales volumes driven by the continued launch in Europe and certain markets in the Middle East.
Current wording
•Global SKYCLARYS revenue increased $30.6 million, from $102.3 million in 2024 to $132.9 million in 2025, or 29.9%, primarily related to an increase in rest of world sales volumes driven by the continued launch in Europe and certain markets in the Middle East, partially offset by an unfavorable Medicare-related adjustment in the U.S. during the third quarter of 2025 resulting from the IRA redesign.
Previous wording
•Global QALSODY revenue increased $15.0 million, from $5.0 million in 2024 to $20.0 million in 2025, or 300.0%, primarily related to an increase in rest of world sales volumes driven by the continued launch in international markets.
Current wording
•Global QALSODY revenue increased $15.3 million, from $11.1 million in 2024 to $26.4 million in 2025, or 137.8%, primarily related to an increase in rest of world sales volumes driven by the continued launch in international markets.
Previous wording
•U.S. SPINRAZA revenue decreased $2.1 million, from $305.8 million in 2024 to $303.7 million in 2025, or 0.7%.
Current wording
•U.S. SPINRAZA revenue decreased $2.0 million, from $458.9 million in 2024 to $456.9 million in 2025, or 0.4%.
Showing the first 40 of 109 pairs. Open the source sections for the rest.
Rearranged current paragraphs (7)
Current report — wording carried from elsewhere
Drug prices are under significant scrutiny in the markets in which our products are prescribed; for example the IRA has certain provisions related to drug pricing, including the ability for the U.S. government to set prices for certain drugs in Medicare. We expect drug pricing and other healthcare costs will continue to be subject to political and societal pressures on a global basis. As the policy environment remains dynamic, we will continue to monitor how uncertainty with respect to how the U.S. and foreign tariffs and the U.S. and international pricing may impact our business in the future.
Current report — wording carried from elsewhere
•In October 2025 Health Canada issued a Notice of Compliance with Conditions for LEQEMBI for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease who are either apolipoprotein E ε4 non-carriers or heterozygotes and who have confirmed amyloid pathology.
Current report — wording carried from elsewhere
•In September 2025 the National Medical Products Administration in China approved LEQEMBI monthly IV maintenance dosing for the treatment of early Alzheimer's disease.
Current report — wording carried from elsewhere
•In July 2025 the Medicines and Healthcare products Regulatory Agency in the U.K. approved QALSODY for the treatment of ALS in adults who have a mutation in the SOD1 gene.
Current report — wording carried from elsewhere
Additionally, for the nine months ended September 30, 2025, Alzheimer's collaboration revenue reflects the favorable impact from the timing of shipments to China during the second quarter of 2025 as we optimized our global inventory positions.
Current report — wording carried from elsewhere
For the three months ended September 30, 2025, compared to the same period in 2024, the increase in discounts was primarily driven by higher volume discounts in the U.S. and rest of world for TYSABRI, partially offset by lower purchase discounts in rest of world.
Current report — wording carried from elsewhere
•the development of felzartamab for AMR, IgAN and PMN; and
Rearranged previous paragraphs (9)
Previous report — wording carried elsewhere
•Global Interferon revenue decreased $21.5 million, from $494.5 million in 2024 to $473.0 million in 2025, or 4.3%, driven by a decrease in demand as patients transition to higher efficacy therapies.
Previous report — wording carried elsewhere
We expect TECFIDERA revenue will be adversely impacted by accelerating generic competition in certain markets in the E.U. for at least the remainder of the year.
Previous report — wording carried elsewhere
Additionally, a biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We expect that future sales of TYSABRI will continue to be adversely affected by the entrance of this biosimilar in certain international markets.
Previous report — wording carried elsewhere
•the development of felzartamab for AMR, IgAN and PMN.
Previous report — wording carried elsewhere
•discontinuation of BIIB121 for the treatment of Angelman syndrome;
Previous report — wording carried elsewhere
•discontinuation of BIIB105 for the treatment of ALS; and
Previous report — wording carried elsewhere
•discontinuation of BIIB143 for the treatment of diabetic neuropathic pain.
Previous report — wording carried elsewhere
•development of BIIB080 for the treatment of Alzheimer's disease; and
Previous report — wording carried elsewhere
For the six months ended June 30, 2025, compared to the same period in 2024, the increase in acquired in-process research and development, upfront and milestone expense was primarily due to a $165.0 million upfront payment made to Stoke in connection with the closing of our collaboration and license agreement in February 2025, as well as a $35.0 million milestone payment to MorphoSys accrued during the first quarter of 2025 in connection with the first patient dosed in a Phase 3 clinical trial of felzartamab for the treatment of AMR.