Biogen completed the acquisition of Reata Pharmaceuticals in September 2023 for approximately $6.6 billion in cash, adding SKYCLARYS for Friedreich's Ataxia to its marketed products and expanding its clinical and preclinical pipeline programs.

In February 2023, Biogen announced that it is exploring strategic options for its biosimilars business, indicating a potential shift in focus or structure within this segment.

In 2023, Biogen initiated additional cost-saving measures as part of its Fit for Growth program to reduce operating costs, while improving operating efficiency and effectiveness. The Fit for Growth program is expected to generate approximately $1.0 billion in gross operating expense savings and $800.0 million in net operating expense savings by 2025.

Biogen continues to expand its manufacturing capacity, with the second manufacturing suite at the Solothurn facility becoming operational in January 2024. This facility has been approved for the manufacture of ADUHELM and LEQEMBI by the FDA.

Biogen discontinued several research and development programs, including the ENVISION and EMBARK studies for aducanumab, BIIB093, and BIIB132, reflecting a prioritization of research and development efforts.

There were changes in the executive leadership team with the appointment of Jane Grogan as Head of Research and Adam Keeney as Head of Corporate Development.

The 10-K highlights the company's dependence on third-party suppliers and manufacturers, noting that any failure by these parties could lead to supply chain disruptions.

The 10-K acknowledges the increasing frequency and sophistication of cybersecurity threats and incidents, which could compromise information systems and data, leading to liability and operational interruptions.

The 10-K discusses the potential impact of healthcare reform in the U.S., including the Inflation Reduction Act (IRA), and measures being taken worldwide to reduce healthcare costs, which could limit pricing and reimbursement for Biogen's products.

The 10-K acknowledges increasing competition in the MS market from generic versions, prodrugs, and biosimilars, which are likely to be sold at substantially lower prices.

Biosimilar products referencing RITUXAN have launched in the U.S and are being offered at lower prices. This competition has had a significant adverse impact on the pre-tax profits of our collaboration arrangements with Genentech

The 10-K highlights that LEQEMBI and SKYCLARYS are in the early stages of commercial launch in the U.S., with potential risks associated with reimbursement, market acceptance, and competition.

Biogen initiated the Fit for Growth program to reduce operating costs and improve efficiency, targeting $1.0 billion in gross operating expense savings and $800.0 million in net operating expense savings by 2025.

The 10-K mentions that the Solothurn facility is not yet being fully utilized, resulting in the recording of excess capacity charges, which could negatively affect the company's financial condition.

The 10-K notes that factors such as geopolitical events, global health outbreaks, weather events, labor or raw material shortages, and other supply chain disruptions could result in difficulties and delays in manufacturing products.

The 10-K states that Biogen intends to continue committing significant resources to targeted research and development opportunities where there is a significant unmet need and where a drug candidate has the potential to be highly differentiated.

Biogen's research efforts are focused on biologics, small molecule, antisense, gene therapy, and other technologies to target specific medical needs.

As Biogen refocusses its investment in gene therapy, the company is evaluating alternative uses for the new gene therapy manufacturing facility in RTP, North Carolina.

Biogen completed the acquisition of Reata in September 2023 for $7.2 billion, demonstrating a significant capital allocation towards expanding its rare disease portfolio.

The 10-K states that there were no share repurchases of common stock during 2023, although $2.1 billion remained available under the 2020 Share Repurchase Program.

The 10-K notes that R&D expense increased by 10.3% in 2023, indicating continued investment in the pipeline.

The 10-K states that ESG oversight is formally embedded into the Board of Director's corporate governance principles and the Board of Directors annually review our ESG strategy and short-and long-term goals.

A portion of employees' and executive officers' compensation continues to be tied to advancing our ESG efforts.

The 10-K notes that Biogen expects to be required to comply with both the CCDAA and CRFRA and are actively evaluating the requirements under these acts in order to prepare for compliance.

The 10-K acknowledges that global economic conditions and geopolitical tensions, including the conflict between Russia and Ukraine and the military conflict in the Middle East, pose risks to Biogen's business.

The 10-K notes that Biogen expects to be required to comply with both the CCDAA and CRFRA and are actively evaluating the requirements under these acts in order to prepare for compliance.

The 10-K states that competition in the biopharmaceutical industry and the markets in which Biogen operates is intense.