BIOGEN INC.

Previous wording

The U.S. Secretary of Commerce previously initiated an investigation to determine the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, key starting materials and derivative products of those items, under Section 232 of the Trade Expansion Act of 1962. In April 2026 after the investigation concluded, the U.S. Administration issued a Proclamation imposing a 100% tariff on imports of patented pharmaceuticals, biologics and associated ingredients, subject to certain exemptions and reduced rates. The Proclamation tariffs are effective for certain categories on July 31, 2026, and others on September 29, 2026.

Current wording

The U.S. Secretary of Commerce previously initiated an investigation to determine the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, key starting materials and derivative products of those items, under Section 232 of the Trade Expansion Act of 1962. In April 2026 after the investigation concluded, the U.S. Administration issued a Proclamation imposing a 100% tariff on imports of patented pharmaceuticals, biologics and associated ingredients, subject to certain exemptions and reduced rates. The Proclamation tariffs went into effect for certain categories on July 31, 2026, and others on September 29, 2026.

Previous wording

We have a significant manufacturing presence in the U.S. While our portfolio is evolving, approximately three quarters of our 2025 U.S. product revenue was attributable to products that were largely manufactured in the U.S. However, we, and the biopharmaceutical industry, do utilize partners and production facilities located outside the U.S. for certain raw materials, ingredients, processes and components for our products and their delivery technologies. 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 a significant manufacturing presence in the U.S. While our portfolio is evolving, approximately three quarters of our 2026 and 2025 U.S. product revenue were attributable to products that were largely manufactured in the U.S. However, we, and the biopharmaceutical industry, do utilize partners and production facilities located outside the U.S. for certain raw materials, ingredients, processes and components for our products and their delivery technologies. 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 are closely monitoring ongoing geopolitical tensions in the Middle East, including the recent conflict involving the U.S., Israel and Iran, and the related regional instability. The ongoing geopolitical conflicts in the region could lead to significant disruption of fuel and energy supplies and increases in global fuel prices, which could heighten inflationary pressures, disrupt global supply chains and adversely impact the availability and pricing of raw materials. For example, our primary shipping method for resources and finished goods is through air freight. We will continue to evaluate and take actions to mitigate any potential impacts on our business, results of operations and financial condition. Although the long-term effects remain uncertain, this geopolitical conflict did not have any material effects on our results of operations for thethree and six months ended June 30, 2026.

Current wording

We are closely monitoring ongoing geopolitical tensions in the Middle East, including the recent conflict involving the U.S., Israel and Iran, and the related regional instability. The ongoing geopolitical conflicts in the region could lead to significant disruption of fuel and energy supplies and increases in global fuel prices, which could heighten inflationary pressures, disrupt global supply chains and adversely impact the availability and pricing of raw materials. For example, our primary shipping method for resources and finished goods is through air freight. We will continue to evaluate and take actions to mitigate any potential impacts on our business, results of operations and financial condition. Although the long-term effects remain uncertain, this geopolitical conflict did not have any material effects on our results of operations for thethree and nine months ended September 30, 2026.

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 other global geopolitical developments 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 2.0% of total revenue for the three and six months ended June 30, 2026 and 2025. Additionally, revenue generated from sales in the broader Middle East region represents less than 3.0% of total revenue for the three and six months ended June 30, 2026 and 2025.

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 other global geopolitical developments 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 2.0% of total revenue for the three and nine months ended September 30, 2026 and 2025. Additionally, revenue generated from sales in the broader Middle East region represents less than 3.0% of total revenue for the three and nine months ended September 30, 2026 and 2025.

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 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 wording

Drug prices are under significant scrutiny in many of the markets in which our products are prescribed. For example, legislation like the IRA has certain provisions related to drug pricing, including the ability for the U.S. government to exert considerable influence over prices for certain drugs in Medicare. Additional regulatory or executive actions in the U.S., including those relating to MFN pricing, have been issued or proposed concerning drug pricing and rebates. In addition, many European countries require negotiation of the commercial price within their country and the timelines associated with these pricing approvals has, in some cases, lengthened and have more uncertain outcomes. 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 legislative and regulatory developments and how U.S. and international drug pricing may impact our business in the future.

Previous 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 medicines, 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

Increasingly, our ability to set or influence 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 are using a variety of cost-containment measures to control the cost of medicines and achieve economic and budgetary objectives, including price cuts, arbitration hearings, pharmaceutical taxes, mandatory rebates, volume caps, value-based pricing and reference pricing (i.e., referencing prices in other countries and using those reference prices to set a price).

Previous wording

Our failure to obtain or maintain adequate coverage, pricing or reimbursement for our products could have an adverse effect on our business, reputation, revenue and results of operations, could curtail or eliminate our ability to adequately fund research and development programs for the discovery and commercialization of new products and/or could cause a decline or volatility in our stock price.

Current wording

If our efforts to obtain or maintain adequate coverage, pricing or reimbursement for our products are not successful, it could have an adverse effect on our business, reputation, revenue and results of operations, could curtail or eliminate our ability to adequately fund research and development programs for the discovery, launch or commercialization of new products and/or could cause a decline or volatility in our stock price.

Previous wording

The IRA's drug pricing controls and Medicare Part D redesign had an adverse impact on our sales, particularly for our products that are more substantially reliant on Medicare reimbursement. The IRA Medicare Part D redesign had a modest net unfavorable impact to our full-year 2025 revenue of approximately $90.0 million, concentrated in our SKYCLARYS and MS portfolio product revenue, approximately a quarter of which was associated with SKYCLARYS.

Current wording

The IRA's drug pricing controls and Medicare Part D redesign have had an adverse impact on our sales, particularly for our products that are more substantially reliant on Medicare reimbursement. The IRA Medicare Part D redesign had a modest net unfavorable impact to our revenue, concentrated in our SKYCLARYS and MS portfolio product revenue.

Previous wording

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. The full extent of the IRA's impact on our sales and, in turn, our business, remains uncertain.

Current wording

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. The full extent of the IRA's impact on our sales and, in turn, our business, remains uncertain.

Previous wording

Additionally, in May 2025 the U.S. government issued an executive order aiming to establish an MFN drug pricing policy that would tie U.S. drug prices to the prices paid for drugs in other developed countries. If HHS sets MFN pricing targets for prescription drugs, including the use of international reference pricing to set drug prices in the U.S., it could result in reduced prices and reimbursement for certain of our products in the U.S. We continue to evaluate the potential impact of this executive order. This executive order and any additional legislation, regulations or initiatives related to drug pricing, such as the CMS-proposed MFN initiatives, the Global Benchmark for Efficient Drug Pricing for certain Medicare Part B drugs and the Guarding U.S. Medicare Against Rising Drug Costs for certain Medicare Part D drugs, could create additional uncertainty around the timing and prioritization around worldwide commercial efforts and adversely impact our business and results of operations.

Current wording

Additionally, in May 2025 the U.S. government issued an executive order aiming to establish an MFN drug pricing policy that would tie U.S. drug prices to the prices paid for drugs in other developed countries. HHS actions to set MFN pricing targets for prescription drugs, including the use of international reference pricing to set drug prices in the U.S. may result in reduced prices and reimbursement for certain of our products in the U.S.

Previous wording

•Specialized immunology revenue of $127.8 million

Current wording

•Specialized immunology revenue of $242.8 million

Previous wording

•The increase in rare disease product revenue was primarily due to revenue growth from our launch products, including SKYCLARYS and QALSODY as well as the launch of the high dose regimen of SPINRAZA, partially offset by unfavorable inventory dynamics resulting from timing of shipments of SPINRAZA in certain international markets.

Current wording

•The increase in rare disease product revenue was primarily due to the continued launch of the high-dose regimen of SPINRAZA as well as revenue growth from our launch products, including SKYCLARYS, QALSODY and ZURZUVAE, partially offset by unfavorable inventory dynamics resulting from timing of shipments of SPINRAZA in certain international markets.

Previous wording

•U.S. revenue for SYFOVRE and EMPAVELI was $127.8 million, which we began recognizing during the quarter, subsequent to our acquisition of Apellis on May 14, 2026.

Current wording

•U.S. revenue for SYFOVRE and EMPAVELI was $242.8 million.

Previous wording

•ZURZUVAE revenue of $70.8 million in the second quarter of 2026 was driven by the continued launch in the U.S.

Current wording

•ZURZUVAE revenue of $84.4 million in the third quarter of 2026 was driven by the continued launch in the U.S.

Previous wording

•R&D expense increased $130.6 million, or 32.7%

Current wording

•R&D expense increased $137.9 million, or 31.6%

Previous wording

•SG&A expense increased $125.9 million, or 21.6%

Current wording

•SG&A expense increased $157.2 million, or 26.4%

Previous wording

•Acquired IPR&D, upfront and milestone expense increased $117.4 million, or 251.9%

Current wording

•Acquired IPR&D, upfront and milestone expense increased $281.7 million

Previous wording

•The increase in cost of sales was primarily due to higher amortization costs associated with the acquired inventory fair value step-up adjustment, which increased by $112.8 million, as well as higher revenues.

Current wording

•The increase in cost of sales was primarily due to higher amortization costs associated with the acquired inventory fair value step-up adjustment, which increased by $135.7 million, primarily driven by the Apellis acquisition, as well as higher product revenues. The increase was partially offset by a charge recorded during the third quarter of 2025 of approximately $104.3 million related to a litigation matter.

Previous wording

•The increase in R&D expense was primarily due to approximately $37.5 million of step-up amortization related to SKYCLARYS inventory, higher spend on clinical trials, including felzartamab, salanersen and litifilimab as well as operating expense from Apellis.

Current wording

•The increase in R&D expense was primarily due tohigher spend on clinical trials, including felzartamab, salanersen and litifilimab as well as additional expenses resulting from our acquisition of Apellis.

Previous wording

•The increase in acquired IPR&D, upfront and milestone expense was due to $164.0 million in upfront and milestone payments in the second quarter of 2026, primarily driven by our agreement with TJ Bio.

Current wording

•The increase in acquired IPR&D, upfront and milestone expense was due to $283.8 million in upfront and milestone charges recorded in the third quarter of 2026, primarily driven by our RayThera acquisition.

Previous wording

•Cash, cash equivalents and marketable securities totaled approximately $1.3 billion as of June 30, 2026, compared to approximately $4.2 billion as of December 31, 2025. The decrease was primarily due to total consideration paid of $5.1 billion for our acquisition of Apellis, net of cash acquired, partially offset by net borrowings of $1.8 billion.

Current wording

•Cash, cash equivalents and marketable securities totaled approximately $1.3 billion as of September 30, 2026, compared to approximately $4.2 billion as of December 31, 2025. The decrease was primarily due to total consideration paid of $5.1 billion for our acquisition of Apellis, net of cash acquired, partially offset by net borrowings of $1.4 billion.

Previous wording

•We generated approximately $1.1 billion of net cash flow from operations for the six months ended June 30, 2026, compared to approximately $420.2 million in the prior year comparative period. The increase was primarily due to higher worldwide tax payments in 2025.

Current wording

•We generated approximately $1.7 billion of net cash flow from operations for the nine months ended September 30, 2026, compared to approximately $1.7 billion in the prior year comparative period.

Previous wording

In June 2026 we entered into a definitive agreement to acquire all of the issued and outstanding shares of RayThera Inc., a private biotechnology company focused on discovering and developing small molecule therapies in immunology. RayThera's portfolio includes a lead program which entered Phase 1 development during the third quarter of 2026 and other anti-inflammatory assets that could potentially treat immune-mediated conditions across a range of indications.

Current wording

On August 6, 2026, we completed the acquisition of all of the issued and outstanding shares of RayThera Inc., a private biotechnology company focused on discovering and developing small molecule therapies in immunology. RayThera's portfolio includes a lead program which entered Phase 1 development during the third quarter of 2026 that could potentially treat immune-mediated conditions across a range of indications.

Previous wording

The proposed acquisition excludes certain preclinical assets, which will be divested from RayThera into a newly formed independent company prior to the expected closing of this acquisition.

Current wording

This acquisition excluded certain preclinical assets, which were divested from RayThera into a newly formed independent company prior to the closing of this acquisition.

Previous wording

For additional information on our proposed acquisition of RayThera, please read Note 2, Acquisitions, to our condensed consolidated financial statements included in this report.

Current wording

For additional information on our acquisition of RayThera, please read Note 2, Acquisitions, to our condensed consolidated financial statements included in this report.

Previous wording

Under the terms of this agreement we made an upfront payment of $100.0 million to TJ Bio, which was recorded in acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for the three and six months ended June 30, 2026.

Current wording

Under the terms of this agreement we made an upfront payment of $100.0 million to TJ Bio, which was recorded in acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for the nine months ended September 30, 2026.

Previous wording

In connection with the closing of this transaction we accrued an upfront payment of $20.0 million to Alteogen, which was recognized in acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for the six months ended June 30, 2026, and was paid during the second quarter of 2026.

Current wording

In connection with the closing of this transaction we accrued an upfront payment of $20.0 million to Alteogen, which was recognized in acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for the nine months ended September 30, 2026, and was paid during the second quarter of 2026.

Previous wording

In connection with the closing of this transaction we accrued an upfront payment of $12.0 million to Alloy, which was recognized in acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for the six months ended June 30, 2026, and was paid during the second quarter of 2026.

Current wording

In connection with the closing of this transaction we accrued an upfront payment of $12.0 million to Alloy, which was recognized in acquired in-process research and development, upfront and milestone expense within our condensed consolidated statements of income for the nine months ended September 30, 2026, and was paid during the second quarter of 2026.

Previous wording

•In May 2026 the FDA extended the review period by three months for the supplemental BLA for LEQEMBI subcutaneous autoinjector, LEQEMBI IQLIK, for a weekly initiation dose, with a new PDUFA action date of August 24, 2026; in July 2026 the FDA approved the supplemental BLA.

Current wording

•In July 2026 the FDA approved the supplemental BLA for LEQEMBI subcutaneous autoinjector, LEQEMBI IQLIK, for a weekly initiation dose, which became commercially available in the U.S. in August 2026.

Previous wording

•In May 2026, we announced topline results from the Phase 2 CELIA study evaluating diranersen, an investigational ASO therapy targeting tau, in individuals with early Alzheimer's disease. CELIA did not meet its primary endpoint assessing dose response; based upon what we believe to be an unprecedented combination of reduction in tau pathology and clinical benefit, including cognition, we plan to advance diranersen to registrational development.

Current wording

•In May 2026 we announced topline results from the Phase 2 CELIA study evaluating diranersen, an investigational ASO therapy targeting tau, in individuals with early Alzheimer's disease. CELIA did not meet its primary endpoint assessing dose response. In July 2026 we announced data from the Phase 2 CELIA study. The data, presented at the Alzheimer’s Association International Conference 2026, expand upon previously reported topline results and demonstrate a combination of meaningful clinical efficacy and robust biomarker effects, providing Phase 2 proof of concept for diranersen’s tau-directed mechanism of action. Based on the growing and consistent body of evidence from the Phase 1b and Phase 2 studies and upon what we believe to be a combination of reduction in tau pathology and clinical benefit, including cognition, we plan to advance diranersen into confirmatory Phase 3 development.

Previous wording

•In March 2026 the FDA approved the high dose regimen of SPINRAZA, which is comprised of 50 mg/5 mL and 28mg/5 mL doses for the treatment of SMA.

Current wording

•In March 2026 the FDA approved the high-dose regimen of SPINRAZA, which is comprised of 50 mg/5 mL and 28 mg/5 mL doses for the treatment of SMA.

Previous wording

•Global TECFIDERA revenue decreased $102.7 million, from $193.6 million in 2025 to $90.9 million in 2026, or 53.0%, driven by a decrease in global demand, particularly in Europe, as a result of multiple TECFIDERA generic entrants.

Current wording

•Global TECFIDERA revenue decreased $86.2 million, from $168.2 million in 2025 to $82.0 million in 2026, or 51.2%, driven by a decrease in global demand, particularly in Europe, as a result of multiple TECFIDERA generic entrants.

Previous wording

•Global Interferon revenue decreased $21.6 million, from $246.7 million in 2025 to $225.1 million in 2026, or 8.8%, driven by a decrease in global demand as patients continue the long-term trend of transitioning to oral and higher efficacy therapies, partially offset by an increase in pricing in the U.S.

Current wording

•Global Interferon revenue decreased $38.7 million, from $246.9 million in 2025 to $208.2 million in 2026, or 15.7%, driven by a decrease in global demand as patients continue the long-term trend of transitioning to oral and higher efficacy therapies and unfavorable pricing.

Previous wording

•Global TYSABRI revenue increased $56.2 million, from $836.1 million in 2025 to $892.3 million in 2026, or 6.7%, primarily due to a favorable pricing change in the U.S. and the favorable impact of foreign currency exchange.

Current wording

•Global TYSABRI revenue increased $61.5 million, from $1,267.9 million in 2025 to $1,329.4 million in 2026, or 4.9%, primarily due to a favorable pricing change in the U.S. and the favorable impact of foreign currency exchange.

Previous wording

•Global VUMERITY revenue increased $24.4 million, from $351.1 million in 2025 to $375.5 million in 2026, or 6.9%, primarily due to favorable pricing in the U.S., partially offset by inventory dynamics.

Current wording

•Global VUMERITY revenue increased $1.8 million, from $565.7 million in 2025 to $567.5 million in 2026, or 0.3%, primarily due to favorable pricing in the U.S and the favorable impact of foreign currency exchange, partially offset by a shift in patient dynamics resulting from changes in the U.S. Medicare Part D.

Previous wording

•Global TECFIDERA revenue decreased $199.3 million, from $399.7 million in 2025 to $200.4 million in 2026, or 49.9%, driven by a decrease in global demand, particularly in Europe, as a result of multiple TECFIDERA generic entrants.

Current wording

•Global TECFIDERA revenue decreased $285.5 million, from $567.9 million in 2025 to $282.4 million in 2026, or 50.3%, driven by a decrease in global demand, particularly in Europe, as a result of multiple TECFIDERA generic entrants.

Previous wording

•Global Interferon revenue decreased $20.4 million, from $473.0 million in 2025 to $452.6 million in 2026, or 4.3%, driven by a decrease in global demand as patients continue the long-term trend of transitioning to oral and higher efficacy therapies, partially offset by an increase in pricing in the U.S. and the favorable impact of foreign currency exchange.

Current wording

•Global Interferon revenue decreased $59.1 million, from $719.9 million in 2025 to $660.8 million in 2026, or 8.2%, driven by a decrease in global demand as patients continue the long-term trend of transitioning to oral and higher efficacy therapies, partially offset by an increase in pricing in the U.S. and the favorable impact of foreign currency exchange.

Previous wording

In 2026 we expect total MS revenue will decline as a result of high levels of 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., and we expect TYSABRI revenue to continue to be adversely affected by the entrance of a biosimilar.

Current wording

We expect total MS revenue to continue to decline as a result of high levels of 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., and we expect TYSABRI revenue to continue to be adversely affected by the entrance of a biosimilar.

Previous wording

•U.S. SPINRAZA revenue increased $42.8 million, from $303.7 million in 2025 to $346.5 million in 2026, or 14.1% primarily driven by demand and stocking for the high-dose regimen.

Current wording

•U.S. SPINRAZA revenue increased $93.2 million, from $153.2 million in 2025 to $246.4 million in 2026, or 60.8%, primarily driven by demand and stocking for the high-dose regimen as well as a favorable pricing change.

Previous wording

•Rest of world SPINRAZA revenue decreased $45.8 million, from $243.4 million in 2025 to $197.6 million in 2026, or 18.8%, primarily due to unfavorable inventory dynamics resulting from timing of shipments of SPINRAZA in certain international markets, partially offset by higher pricing of the high dose regimen and the favorable impact of foreign currency exchange.

Current wording

•Rest of world SPINRAZA revenue decreased $6.6 million, from $220.8 million in 2025 to $214.2 million in 2026, or 3.0%, primarily due to unfavorable inventory dynamics resulting from timing of shipments of SPINRAZA in certain international markets, partially offset by the launch of high-dose regimen.