CELG Celgene Corporation

Risks

• Our operating results may be subject to significant fluctuations.
• Our future commercial success depends on gaining regulatory approval for products in development, and obtaining approvals for our current products for additional indications.
• If we fail to comply with laws or government regulations or policies our business could be adversely affected.
• Sales of our products will be significantly reduced if access to and reimbursement for our products by governmental and other third-party payers are reduced or terminated.
• Federal and state legislation may affect our pricing policies and government reimbursement of our products which may adversely impact our revenues and profitability.
• Our ability to sell our products to hospitals in the United States depends in part on our relationships with group purchasing organizations.
• Our products may face competition from lower cost generic or follow-on products.
• Certain novel approaches to the treatment of diseases, such as chimeric antigen receptor (CAR) T cell therapy, may present significant challenges and risks for us.
• Our business operates in an extremely competitive environment.
• A decline in general economic conditions would adversely affect our results of operations.
• We may be required to modify our business practices, pay fines and significant expenses or experience other losses due to governmental investigations or other enforcement activities.
• The development of new biopharmaceutical products involves a lengthy and complex process and we may be unable to commercialize any of the products we are currently developing.
• Disruptions of our manufacturing and distribution operations could significantly interrupt our production and distribution capabilities.
• The consolidation of drug wholesalers and other wholesaler actions could increase competitive and pricing pressures.
• Risks from the improper conduct of employees, agents, contractors or collaborators could adversely affect our business or reputation.
• We are subject to a variety of risks related to the conduct and expansion of our business internationally, particularly in emerging markets.
• We may not realize the anticipated benefits of acquisitions and strategic initiatives.
• We may not be able to continue to attract and retain highly qualified managerial, scientific, manufacturing and commercial talent.
• Risks associated with using hazardous materials in our business could subject us to significant liability.
• We are subject to various legal proceedings, claims and investigative demands in the ordinary course of our business, the ultimate outcome of which may result in significant expense, payments and penalties.
• Product liability claims could adversely affect our business, results of operations and financial condition.
• Changes in our effective income tax rate could adversely affect our results of operations.
• Currency fluctuations and changes in exchange rates could adversely affect our revenue growth, increase our costs and cause our profitability to decline.
• We may experience an adverse market reaction if we are unable to meet our financial reporting obligations.
• Impairment charges or write downs in our books and changes in accounting standards could have a significant adverse effect on our results of operations and financial condition.
• The price of our common stock may fluctuate significantly.
• Our business would be adversely affected if we are unable to service our debt obligations.
• A breakdown or breach of our information technology systems and cyber security efforts could subject us to liability, reputational damage or interrupt the operation of our business.
• The illegal distribution and sale by third parties of counterfeit versions of our products or stolen products could have a negative impact on our reputation and business.
• We have certain charter and by-law provisions that may deter a third party from acquiring us and may impede the stockholders’ ability to remove and replace our management or board of directors.
• In addition to the risks relating to our common stock, holders of our CVRs are subject to additional risks.
• While the merger is pending, we are subject to business uncertainties and contractual restrictions that could materially adversely affect our operating results, financial position and/or cash flows or result in a loss of employees, customers, collaborators or suppliers.
• Lawsuits have been filed against us and Bristol-Myers Squibb and other lawsuits may be filed against us and/or Bristol-Myers Squibb challenging the transactions contemplated by the merger agreement. An adverse ruling in any such lawsuit may delay or prevent the proposed acquisition from being completed.
• We may have difficulty attracting, motivating and retaining executives and other key employees in light of the merger.