BIOGEN INC.
For the period ended Jun 30, 2025. Filed Jul 31, 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.
Jun 30, 2025 · Filed Jul 31, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-01.
0000875045-25-000018
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 327 previous paragraphs and 399 current paragraphs.
208 unchanged; 94 reworded; 86 added; 22 removed; 3 previous and 11 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 (86)
Current report
2025 LEGISLATION AND TAX REFORM
Current report
On July 4, 2025, the U.S. signed into law the H.R.1 legislation formally titled "An Act to Provide for Reconciliation Pursuant to Title II of H. Con. Res. 14", commonly referred to as the OBBBA.
Current report
The OBBBA contains tax provisions, such as the permanent extension or revision of certain expiring provisions of the Tax Cuts and Jobs Act enacted in 2017, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The provisions of the OBBBA have multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027.
Current report
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 report
The OBBBA also enacts significant potential changes to Medicaid funding and rescinds or does not continue elements of the PPACA. The OBBBA implements additional eligibility rules on government health plans, expands administrative procedures around enrollment, modifies how states can obtain federal funding for Medicaid and no longer extends ACA premium subsidies. Additional federal and state guidance is expected to be issued in order to implement these OBBBA provisions, most of which have effective dates in 2027 and 2028.
Current report
At this time, we are unable to determine the overall impact that the OBBBA will have on our business, results of operations and financial condition, or the impact the OBBBA will have on the pharmaceutical industry as a whole because any such impact will depend upon developing interpretations of the OBBBA provisions and implementing regulations, which may be material.
Current report
$180.6 million or 7.3%
Current report
$0.33 or 8.3%
Current report
$20.9 million or 1.1%
Current report
•MS revenue decreased $42.6 million, or 3.7%
Current report
•Rare disease revenue increased $8.9 million, or 1.7%
Current report
•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 report
$135.3 million or 7.7%
Current report
•Cost of sales increased $59.0 million, or 10.8%
Current report
•SG&A expense increased $30.0 million, or 5.4%
Current report
•In May 2025 we issued our 2025 Senior Notes for an aggregate principal amount of $1.75 billion. In June 2025 we used the net proceeds to redeem our 4.050% Senior Notes due September 15, 2025, prior to maturity.
Current report
2025 SENIOR NOTES
Current report
On May 12, 2025, we issued our 2025 Senior Notes for an aggregate principal amount of $1.75 billion. In June 2025 we used the net proceeds from the sale of our 2025 Senior Notes to redeem our 4.050% Senior Notes due September 15, 2025, prior to maturity.
Current report
For additional information relating to our 2025 Senior Notes, please read Note 13, Indebtedness, to our condensed consolidated financial statements included in this report.
Current report
CITY THERAPEUTICS, INC. COLLABORATION
Current report
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 report
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 report
For additional information on our strategic research arrangement with City Therapeutics, please read Note 19, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.
Current report
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 report
•In June 2025 we filed a request for arbitration in the International Court of Arbitration of the International Chamber of Commerce seeking adoption of a budget and commercialization plan for the European Territory that allocates commercialization activities to Biogen and Eisai in an equitable fashion taking into account our respective capabilities and provides a meaningful role for each party.
Current report
ZURZUVAE (zuranolone)
Current report
In July 2025 the CHMP of the EMA adopted a positive opinion recommending the marketing authorization for zuranolone for the treatment of PPD.
Current report
SALANERSEN (BIIB115)
Current report
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 report
SKYCLARYS (omaveloxolone)
Current report
In June 2025 we announced the initiation of dosing in the global Phase 3 BRAVE study. This study will evaluate the efficacy and safety of omaveloxolone in children with FA between the ages of two and sixteen years old.
Current report
(1) Other includes ZURZUVAE, FUMADERM and ADUHELM.
Current report
•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 report
•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 report
•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 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.
Current 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.
Current report
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.
Current report
•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 report
•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.
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Removed paragraphs (22)
Previous report
CURRENT ECONOMIC CONDITIONS
Previous report
GLOBAL SUPPLY CHAIN DISRUPTIONS
Previous report
$140.5 million or 6.1%
Previous report
$1.06 or 39.3%
Previous report
$14.6 million or 0.9%
Previous report
•MS revenue decreased $122.9 million, or 11.4%
Previous report
•Rare disease revenue increased $139.4 million, or 32.9%
Previous report
•The decrease in MS product revenue was primarily due to a decrease in global TECFIDERA and Interferon demand due to increased competition, as well as a decrease in global TYSABRI revenue driven by increased competition, including the impacts from a biosimilar entrant of TYSABRI in Europe, and a decrease in pricing in rest of world TYSABRI.
Previous report
$294.1 million or 16.1%
Previous report
•Cost of sales increased $87.1 million, or 16.1%
Previous report
•SG&A expense decreased $9.0 million, or 1.5%
Previous report
SKYCLARYS
Previous report
Revenue is summarized as follows:
Previous report
(1) Other includes FUMADERM, ADUHELM and ZURZUVAE.
Previous report
•Global VUMERITY revenue increased $11.3 million, from $127.5 million in 2024 to $138.8 million in 2025, or 8.9%, primarily due to an increase in U.S. demand.
Previous report
For the three months ended March 31, 2025 and 2024, we recognized approximately $33.0 million and $2.8 million, respectively, of Alzheimer's collaboration revenue within our condensed consolidated statements of income.
Previous report
•increased spend on felzartamab for AMR; and
Previous report
For additional information on our collaboration and license agreement with Stoke and our third-party agreement with MorphoSys, please read Note 19, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.
Previous report
We expect selling, general and administrative costs to continue to decline in 2025 due to the continued realization of our cost-reduction measures in connection with our Fit for Growth program.
Previous report
Our ability to liquidate our investments in Denali and Sage may be limited by the size of our interest, the volume of market related activity, our concentrated level of ownership and potential restrictions resulting from our status as a collaborator. Therefore, we may realize significantly less than the current value of such investments.
Previous report
CAPITAL EXPENDITURES
Previous report
In the fourth quarter of 2021 we began construction of a new gene therapy, clinical packaging and other manufacturing facility in RTP, North Carolina to support our gene therapy pipeline across multiple therapeutic areas. The new manufacturing facility will be approximately 197,000 square feet with an estimated total investment of approximately $195.0 million. We estimate the construction of this manufacturing facility will be completed during 2025. As we continue to advance our research and development prioritization efforts, which includes refocusing our investment in gene therapy, we are evaluating several alternative uses for this facility.
Reworded paragraphs (94)
Previous wording
Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI for the treatment of MS; SPINRAZA for the treatment of SMA; SKYCLARYS for the treatment of FA; QALSODY for the treatment of ALS; and FUMADERM for the treatment of severe plaque psoriasis.
Current wording
Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI for the treatment of MS; SPINRAZA for the treatment of SMA; SKYCLARYS for the treatment of FA; and QALSODY for the treatment of ALS.
Previous wording
We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we regularly review our manufacturing capacity, capabilities, processes and facilities. In order to support our future growth and drug development pipeline, we expanded our large molecule production capacity and built a large-scale biologics manufacturing facility in Solothurn, Switzerland. In the second quarter of 2021 a portion of this facility (the first manufacturing suite) received a GMP multi-product license from SWISSMEDIC and was placed into service. The second manufacturing suite, which was also licensed to operate by SWISSMEDIC, became operational in the first quarter of 2024. Solothurn has been approved for the manufacture of LEQEMBI. We believe that the Solothurn facility will support our anticipated near to mid-term needs for the manufacturing of biologic assets. The plant represents a significant increase in our overall manufacturing capacity. If we are unable to fully utilize our manufacturing facilities, we will incur additional excess capacity charges which would have a negative effect on our financial condition and results of operations.
Current wording
We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we regularly review our manufacturing capacity, capabilities, processes and facilities. In order to support our future growth and drug development pipeline, we expanded our large molecule production capacity and built a large-scale biologics manufacturing facility in Solothurn, Switzerland. Solothurn is operational and has been approved for the manufacture of LEQEMBI. We believe that the Solothurn facility will support our anticipated near to mid-term needs for the manufacturing of biologic assets. The plant represents a significant increase in our overall manufacturing capacity. Additionally, we continue to invest to modernize, automate and support the capacity requirements for our pipeline and existing products at our existing manufacturing facilities in RTP, North Carolina. If we are unable to fully utilize our manufacturing facilities, we will incur additional excess capacity charges which would have a negative effect on our financial condition and results of operations.
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.
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 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.
Previous wording
A biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We expect that future sales of TYSABRI may be adversely affected by the entrance of this biosimilar.
Current wording
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
Economic conditions remain vulnerable as markets continue to be impacted in part by elevated inflation, higher interest rates, extreme weather events, global supply chain uncertainties and risks associated with geopolitical conflicts.
Current wording
Economic conditions remain uncertain as markets continue to be impacted in part by elevated inflation, higher interest rates, extreme weather events, global supply chain uncertainties and risks associated with geopolitical conflicts. Global supply chain disruptions, such as strikes, work stoppages, port congestion, port closures, trade restrictions, capacity constraints and other logistical problems, may affect our ability to do business.
Previous wording
For example, the U.S. has imposed a baseline tariff on imports from all countries, subject to certain exceptions. Trade-related tensions between the U.S. and China have led to a series of tariffs and sanctions being imposed by the U.S. on imports from China and retaliatory tariffs imposed by China on U.S. imports.
Current wording
The U.S. has imposed a baseline tariff on imports from all countries, subject to certain exceptions. Trade-related tensions between the U.S. and China have led to a series of tariffs and sanctions being imposed by the U.S. on imports from China and retaliatory tariffs imposed by China on U.S. imports.
Previous wording
In addition, although certain starting materials for SKYCLARYS rely on a single supplier based in China, the manufacturing process, including active pharmaceutical ingredients and drug substance, is primarily conducted in the U.S. We are working to mitigate potential exposure from tariffs across our network.
Current wording
Although certain starting materials for SKYCLARYS rely on a single supplier based in China, the manufacturing process, including active pharmaceutical ingredients and drug substance, is primarily conducted in the U.S.
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. However, 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 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.
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 months ended March 31, 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 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.
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 as of March 31, 2025 and December 31, 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 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.
Previous wording
We expect the IRA's drug pricing controls and Medicare Part D redesign may have an adverse impact on our sales, particularly for our products that are more substantially reliant on Medicare reimbursement. We anticipate the IRA Medicare Part D redesign will have a modest net unfavorable impact to our 2025 revenue, ranging from approximately $50.0 million to $100.0 million, concentrated in our SKYCLARYS and MS portfolio product revenue, approximately a third of which could be associated with SKYCLARYS.
Current wording
We expect the IRA's drug pricing controls and Medicare Part D redesign may have an adverse impact on our full-year sales, particularly for our products that are more substantially reliant on Medicare reimbursement. We anticipate the IRA Medicare Part D redesign will have a modest net unfavorable impact to our 2025 revenue, ranging from approximately $50.0 million to $100.0 million, concentrated in our SKYCLARYS and MS portfolio product revenue, approximately a third of which could be associated with SKYCLARYS.
Previous wording
•The increase in rare disease product revenue was primarily due to an increase in rest of world SPINRAZA revenue driven by a one-time VAT refund received during the first quarter of 2025 of approximately $18.1 million and the timing of shipments in rest of world markets, as well as higher revenue from new product launches, including global SKYCLARYS revenue of $123.9 million and global QALSODY revenue of $15.5 million in the first 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 $130.3 million and global QALSODY revenue of $20.0 million in the second quarter of 2025.
Previous wording
•R&D expense decreased $11.3 million, or 2.5%
Current wording
•R&D expense decreased $106.4 million, or 21.1%
Previous wording
•Acquired IPR&D, upfront and milestone expense increased $193.2 million
Current wording
•Acquired IPR&D, upfront and milestone expense increased $38.1 million
Previous wording
•The increase in cost of sales was primarily due to higher contract manufacturing revenue and approximately $51.4 million in SKYCLARYS amortization costs, partially offset by lower inventory write-offs in the first quarter of 2025.
Current wording
•The increase in cost of sales was primarily due to higher contract manufacturing revenue and higher SKYCLARYS amortization costs, partially offset by lower inventory write-offs in the second quarter of 2025.
Previous wording
•The decrease in R&D expense was primarily driven by continued cost reduction measures realized in connection with our portfolio prioritization initiatives and our Fit for Growth program, offset in part by higher spend on clinical trials, including litifilimab and felzartamab. Higher clinical trial spend related to litifilimab was partially offset by$50.0 million in R&D funding received from Royalty Pharma.
Current wording
•The decrease in R&D expense was primarily driven by continued cost reduction measures realized in connection with our portfolio prioritization initiatives and our Fit for Growth program, offset in part by higher spend on clinical trials, including litifilimab and felzartamab. Higher clinical trial spend related to litifilimab was offset by $50.0 million in R&D funding received from Royalty Pharma.
Previous wording
•The increase in acquired IPR&D, upfront and milestone expense was primarily due to an upfront payment of $165.0 million to Stoke in connection with the closing of our collaboration and license agreement in March 2025, as well as a $35.0 million milestone 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.
Current wording
•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 wording
•The decrease in SG&A expense was primarily due to the continued realization of cost-reduction measures in connection with our Fit for Growth program partially offset by an increase in operational spending on sales and marketing activities in support of product launches.
Current 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.
Previous wording
•Cash and cash equivalents totaled approximately $2.6 billion as of March 31, 2025, compared to approximately $2.4 billion as of December 31, 2024.
Current 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.
Previous wording
•We generated approximately $259.3 million of net cash flow from operations for the three months ended March 31, 2025, compared to approximately $553.2 million in the prior year
Current 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.
Previous wording
comparative period. This year-over-year reduction was due in part to the upfront payment of $165.0 million to Stoke in connection with the closing of our collaboration and license agreement in March 2025 as well as higher employee-benefit payments.
Current 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.
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. The 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% 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.
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 initiate a global Phase 3 registrational study in the second 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. In connection with the closing of this transaction, we made an upfront payment of $165.0 million to Stoke.
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 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.
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 expenses. For thethree months ended March 31, 2025, we recorded a reduction to research and development expense of $50.0 million.
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 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.
Previous wording
If litifilimab receives regulatory approval, Royalty Pharma will be eligible to royalties of a mid-single digits percentage of the applicable net sales. Royalties on net sales will be recorded as cost of sales within our condensed consolidated statements of income.
Current wording
If litifilimab receives regulatory approval, Royalty Pharma will be eligible to receive royalties of a mid-single digit percentage of the applicable net sales. Royalties on net sales will be recorded as cost of sales within our condensed consolidated statements of income.
Previous wording
In connection with the initiation of this dosing we accrued a $35.0 million milestone payment to MorphoSys.
Current wording
In June 2025 we announced the initiation of dosing in the global Phase 3 PREVAIL study. This study will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo on proteinuria and preservation of kidney function in adults diagnosed with IgAN. In connection with the initiation of this dosing we accrued a $30.0 million milestone payment to MorphoSys, which was subsequently paid in July 2025. Additionally, in June 2025 we announced the initiation of dosing in the global Phase 3 PROMINENT study. This study will evaluate the efficacy and safety of the investigational drug felzartamab compared to tacrolimus in adults diagnosed with PMN.
Previous wording
In March 2025 we announced the initiation of dosing in the global Phase 3 TRANSCEND study. This study will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo in adult kidney transplant recipients diagnosed with late AMR.
Current wording
In March 2025 we announced the initiation of dosing in the global Phase 3 TRANSCEND study. This study will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo in adult kidney transplant recipients diagnosed with late AMR. In connection with the initiation of this dosing we paid a $35.0 million milestone payment to MorphoSys in April 2025.
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 will receive a payment of $51.0 million, which we expect to receive in July 2025, and recognized a de minimis loss within our condensed consolidated statements of income for the three months ended March 31, 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 six months ended June 30, 2025.
Previous wording
The following revenue discussion should be read in conjunction with Note 5, Revenue, to our condensed consolidated financial statements included in this report.
Current wording
The following revenue discussion should be read in conjunction with Note 5, Revenue, to our condensed consolidated financial statements included in this report. Revenue is summarized as follows:
Previous wording
•Global TYSABRI revenue decreased $49.8 million, from $431.3 million in 2024 to $381.5 million in 2025, or 11.5%, primarily due to increased competition, including the impacts from a biosimilar entrant of TYSABRI in Europe, and a decrease in pricing in rest of world TYSABRI.
Current 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.
Previous wording
•Global TECFIDERA revenue decreased $48.2 million, from $254.3 million in 2024 to $206.1 million in 2025, or 19.0%, driven by a decrease in demand as a result of multiple TECFIDERA generic entrants in North America, Latin America and certain E.U. countries.
Current 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.
Previous wording
•Global Interferon revenue decreased $17.3 million, from $243.6 million in 2024 to $226.3 million in 2025, or 7.1%, driven by a decrease in demand as patients transition to higher efficacy therapies.
Current wording
•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 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. 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 may be adversely affected by the entrance of this biosimilar.
Current wording
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
•Global SKYCLARYS revenue increased $45.9 million, from$78.0 million in 2024 to $123.9 million in 2025, or 58.8%, 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. The increase was partially offset by a decrease in U.S. SKYCLARYS revenue, resulting from the unfavorable impact of Medicare discount dynamics, offset in part by an increase in demand.
Current wording
•Global SKYCLARYS revenue increased $30.3 million, from $100.0 million in 2024 to $130.3 million in 2025, or 30.3%, 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.
Previous wording
•Global QALSODY revenue increased $10.9 million, from $4.6 million in 2024 to $15.5 million in 2025, or 237.0%, 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 $15.0 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.
Previous wording
•U.S. SPINRAZA revenue increased $5.9 million, from $148.5 million in 2024 to $154.4 million in 2025, or 4.0%, primarily due to favorable net pricing.
Current wording
•U.S. SPINRAZA revenue decreased $2.1 million, from $305.8 million in 2024 to $303.7 million in 2025, or 0.7%.
Previous wording
•Rest of world SPINRAZA revenue increased $76.7 million, from $192.8 million in 2024 to $269.5 million in 2025, or 39.8%, partially due to a one-time VAT refund received during the first quarter of 2025 of approximately $18.1 million and the timing of shipments in rest of world markets.
Current wording
•Rest of world SPINRAZA revenue increased $48.3 million, from $464.6 million in 2024 to $512.9 million in 2025, or 10.4%, partially due to a one-time VAT refund received in 2025 of approximately $18.1 million and the timing of shipments in rest of world markets, partially offset by lower demand and the unfavorable impact of foreign currency exchange.
Previous wording
•For the three months ended March 31, 2025, compared to the same period of 2024, the decrease in biosimilar revenue was primarily due to a decrease in sales volumes related to IMRALDI, the unfavorable impact of foreign currency exchange and a decrease in pricing due to competitive pressures in Europe.
Current wording
•For the six months ended June 30, 2025, compared to the same period in 2024, the decrease in biosimilar revenue was primarily due to a decrease in sales volumes related to IMRALDI, the unfavorable impact of foreign currency exchange and a decrease in pricing due to competitive pressures in Europe.
Previous wording
For the three months ended March 31, 2025, compared to the same period in 2024, the decrease in royalty revenue on sales of OCREVUS was primarily due to a change in estimate recorded in the first quarter of 2025 related to prior period OCREVUS sales estimates. Global sales growth of OCREVUS was relatively flat as compared to the first quarter of 2024.
Current wording
For the three and six months ended June 30, 2025, compared to the same periods in 2024, the increases in royalty revenue on sales of OCREVUS were primarily due to sales growth of OCREVUS in the U.S.
Previous wording
For the three months ended March 31, 2025, compared to the same period in 2024, the decrease in our share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO was primarily due to a decrease in sales volumes of RITUXAN in the U.S. of 8.9%, resulting from competition from multiple biosimilar products, partially offset by an increase in sales volumes of GAZYVA of 17.2%.
Current wording
For the three and six months ended June 30, 2025, compared to the same periods in 2024, the increases in our share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO were primarily due to increases in sales volumes of GAZYVA of 13.3% and 15.2%, respectively, partially offset by decreases in sales volumes of RITUXAN of 7.2% and 8.1%, respectively, as a result of competition from multiple biosimilar products.
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Current report — wording carried from elsewhere
We are working to mitigate potential exposure from tariffs across our network.
Current report — wording carried from elsewhere
The degree of impact from this legislation on our business depends on a number of forthcoming implementation actions by regulatory authorities, which may be further impacted by other legislative acts that may modify or replace the IRA, such as the OBBBA, as discussed below. The full extent of the IRA's impacts on our sales and, in turn, our business, remains uncertain.
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
•For the three months ended June 30, 2025, compared to the same period of 2024, the decrease in biosimilar revenue was primarily due to a decrease in sales volumes related to IMRALDI and a decrease in pricing due to competitive pressures in Europe.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
The decrease in late stage program expense was driven by a decrease in costs associated with:
Current report — wording carried from elsewhere
The decrease in early stage programs was driven by a decrease in costs associated with:
Current report — wording carried from elsewhere
•discontinuation of BIIB121 for the treatment of Angelman syndrome;
Current report — wording carried from elsewhere
•development of litifilimab for the treatment of CLE and increased spend in SLE, offset by Royalty Pharma funding of $100.0 million.
Current report — wording carried from elsewhere
•decreased spend on LEQEMBI for the treatment of Alzheimer's disease.
Current report — wording carried from elsewhere
For the three months ended June 30, 2025, net unrealized and realized gains on our holdings in equity securities were approximately $5.3 million and zero, respectively, compared to net unrealized and realized losses of approximately $29.8 million and $0.6 million, respectively, in the prior year comparative period.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Global supply chain disruptions, such as strikes, work stoppages, port congestion, port closures, trade restrictions, capacity constraints and other logistical problems, may affect our ability to do business.
Previous report — wording carried elsewhere
For the three months ended March 31, 2025, compared to the same period in 2024, the decrease in returns was primarily driven by lower returns in the U.S.
Previous report — wording carried elsewhere
The decrease was partially offset by an increase in costs associated with: