BIOGEN INC. (BIIB) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that BIOGEN INC. surfaced in its latest filing.

• In May 2026, we completed our acquisition of Apellis, which became a wholly-owned subsidiary.May 2026
• LEQEMBI commercialized in the U.S. and certain international markets.
• SKYCLARYS in early commercial launch in certain European markets.
• Seeking approval of a subcutaneous formulation of LEQEMBI as a starting dose in the U.S.
• The Inflation Reduction Act's drug pricing controls and Medicare Part D redesign expected to have an adverse impact on sales.
• The OBBBA, signed into law in July 2025, enacts significant potential changes to Medicaid funding and other provisions, with most provisions effective in 2027 and 2028.July 2025
• Executive order aiming to establish an MFN drug pricing policy that would tie U.S. drug prices to prices in other developed countries.
• CMS-proposed MFN initiatives, including 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, are being debated.
• One of our contract manufacturers for IMRALDI and BENEPALI was acquired by a third party in 2024.2024
• The SEC has adopted additional disclosure rules regarding cybersecurity risk management, strategy, governance, and incident reporting for public companies.
• The EU's General Data Protection Regulation (GDPR) imposes large penalties for noncompliance.
• U.S. data privacy and security laws like the CCPA introduce requirements and potential liability through private actions with statutorily defined damages for certain data breaches.
• The U.S. government has challenged some of our donations to third-party charities that provide patient assistance.
• Specific trade investigations under Section 232 with respect to pharmaceutical imports into the U.S.
• Clinical trial delays attributable to Russia's invasion of Ukraine and the military conflict in the Middle East.
• Solothurn facility was approved by the FDA for LEQEMBI and TYSABRI.
• Building a new clinical packaging and other manufacturing facility in RTP.
• Potential application of the U.S. FCPA to healthcare professionals qualifying as foreign government officials.
• Potential violations of the U.K. Bribery Act 2010.