BIIB Biogen Inc.

Risks

• If we are unable to obtain and maintain adequate protection for our data, intellectual property and other proprietary rights, our business may be harmed.
• The ongoing COVID-19 pandemic may, directly or indirectly, adversely affect our business, results of operations and financial condition.
• Our long-term success depends upon the successful development of new products and additional indications for existing products.
• If we fail to compete effectively, our business and market position would suffer.
• Our business may be adversely affected if we do not successfully execute or realize the anticipated benefits of our strategic and growth initiatives.
• Successful preclinical work or early stage clinical trials does not ensure success in later stage trials, regulatory approval or commercial viability of a product.
• Clinical trials and the development of biopharmaceutical products is a lengthy and complex process. If we fail to adequately manage our clinical activities, our clinical trials or potential regulatory approvals may be delayed or denied.
• Adverse safety events or restrictions on use and safety warnings for our products can negatively affect our business, product sales and stock price.
• Sales of our products depend, to a significant extent, on adequate coverage, pricing and reimbursement from third-party payors, which are subject to increasing and intense pressure from political, social, competitive and other sources. Our inability to obtain and maintain adequate coverage, or a reduction in pricing or reimbursement, could have an adverse effect on our business, reputation, revenues 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 or could cause a decline or volatility in our stock price.
• A breakdown or breach of our technology systems could subject us to liability or interrupt the operation of our business.
• We depend on relationships with collaborators, joint venture partners and other third parties for revenues, and for the development, regulatory approval, commercialization and marketing of certain of our products and product candidates, which are outside of our full control.
• Our results of operations may be adversely affected by current and potential future healthcare reforms.
• Management and key personnel changes may disrupt our operations, and we may have difficulty retaining key personnel or attracting and retaining qualified replacements on a timely basis for management and other key personnel who may leave the Company.
• If we fail to comply with the extensive legal and regulatory requirements affecting the health care industry, we could face increased costs, penalties and a loss of business.
• Our sales and operations are subject to the risks of doing business internationally.
• We are building a large-scale biologics manufacturing facility, which will result in the incurrence of significant investment with no assurance that such investment will be recouped.
• Manufacturing issues could substantially increase our costs, limit supply of our products and/or reduce our revenues.
• Our success in commercializing biosimilars developed by Samsung Bioepis is subject to risks and uncertainties inherent in the development, manufacture and commercialization of biosimilars. If Samsung Bioepis is unsuccessful in the development, manufacture and commercialization of biosimilars, we may not realize the anticipated benefits of our investment in Samsung Bioepis.
• Our operating results are subject to significant fluctuations.
• Our effective tax rate fluctuates, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
• Our investments in properties may not be fully realized.
• Our portfolio of marketable securities is subject to market, interest and credit risk that may reduce its value.
• There can be no assurance that we will continue to repurchase shares or that we will repurchase shares at favorable prices.
• We may not be able to access the capital and credit markets on terms that are favorable to us.
• Our indebtedness could adversely affect our business and limit our ability to plan for or respond to changes in our business.
• Our business involves environmental risks, which include the cost of compliance and the risk of contamination or injury.
• The illegal distribution and sale by third parties of counterfeit or unfit versions of our products or stolen products could have a negative impact on our reputation and business.
• The increasing use of social media platforms presents new risks and challenges.
• Some of our collaboration agreements contain change in control provisions that may discourage a third party from attempting to acquire us.