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Risks

• Risks Related to Our Business
• Risks Related to Development and Clinical Testing of Our Products and Drug Candidates
• Risks Related to Government Regulation
• Risks Related to Business Development Activities
• Risks Related to Third-Party Manufacturing and Reliance on Third Parties
• Risks Related to Intellectual Property
• Risks Related to Our Operations
• Risks Related to Financial Results and Holding Our Common Stock
• All of our product revenues and the vast majority of our total revenues are derived from sales of medicines for the treatment of CF. If we are unable to continue to increase revenues from sales of our CF medicines, our business would be materially harmed and the market price of our common stock would likely decline.
• We are investing significant resources in the research and development of therapies for serious diseases other than CF, and if we are unable to successfully commercialize one or more of these therapies, our business could be materially harmed.
• If our competitors bring drugs with superior product profiles to market, our drugs may not be competitive and our revenues could decline.
• If we discover safety issues with any of our products or if we fail to comply with continuing U.S. and applicable foreign regulations, commercialization efforts for the product could be negatively affected, the approved product could lose its approval or sales could be suspended, and our business could be materially harmed.
• If physicians and patients do not accept our medicines, or if patients do not remain on treatment or comply with their prescribed dosing regimen, our product revenues would be materially harmed in future periods.
• Government and other third-party payors seek to contain costs of health care through legislative and other means. If they fail to provide coverage and adequate reimbursement rates for our products, our revenues will be harmed.
• We have experienced challenges commercializing products outside of the U.S., and our future revenues will be dependent on our ability to obtain adequate reimbursement for our products.
• We have limited experience developing cell and genetic therapies and could experience challenges with these programs, which could result in delays or prevent the development, manufacturing and commercialization of our cell and genetic therapies.
• We are dependent upon a small number of customers for a significant portion of our revenue, and the loss of, or significant reduction in sales to, these customers would adversely affect our results of operations.
• Our drug candidates remain subject to clinical testing and regulatory approval. Our future success is dependent on our ability to successfully develop additional drug candidates for both CF and non-CF indications.
• If we are unable to obtain regulatory approval, we will be unable to commercialize our drug candidates.
• If clinical trials are prolonged or delayed, our development timelines for the affected development program could be extended, our costs to develop the drug candidate could increase and the competitive position of the drug candidate could be adversely affected.
• If regulatory authorities interpret any of our conduct, including our marketing practices, as being in violation of applicable health care laws, including fraud and abuse laws, laws prohibiting off-label promotion, disclosure laws or other similar laws, we may be subject to civil or criminal penalties.
• If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the U.S., we could be subject to additional reimbursement requirements, penalties, sanctions and fines which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
• If our processes and systems are not compliant with regulatory requirements, we could be subject to restrictions on marketing our products or could be delayed in submitting regulatory filings seeking approvals for our drug candidates.
• We are subject to various and evolving laws and regulations governing the privacy and security of personal data, and our failure to comply could adversely affect our business, result in fines and/or criminal penalties, and damage our reputation.
• If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
• Our ability to execute on our long-term strategy depends in part on our ability to engage in transactions and collaborations with other entities that add to our pipeline or provide us with new commercial opportunities.
• We may not realize the anticipated benefits of acquisitions of businesses or technologies, and the integration following any such acquisition may disrupt our business and management.
• We face risks in connection with existing and future collaborations with respect to the development, manufacture and commercialization of our products and drug candidates.
• We may not be able to attract collaborators or external funding for the development and commercialization of certain of our drug candidates.
• We depend on third-party manufacturers to manufacture our products and the materials we require for our clinical trials. We may not be able to maintain these relationships and could experience supply disruptions outside of our control.
• We rely on third parties to conduct pre-clinical work, clinical trials and other activities, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such studies and/or trials or failing to satisfy regulatory requirements.
• If our patents do not protect our drugs or our drugs infringe third-party patents, we could be subject to litigation which could result in injunctions preventing us from selling our products or substantial liabilities.
• Uncertainty over intellectual property in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes, which is inherently costly and unpredictable.
• We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
• Risks associated with operating in foreign countries could materially adversely affect our business.
• We are subject to risks associated with the global COVID-19 pandemic.
• If we fail to manage our operations effectively, our business may suffer.
• If we fail to attract and retain skilled employees, our business could be materially harmed.
• Our business faces potential risks relating to the United Kingdom’s withdrawal from the European Union.
• Our business has a substantial risk of product liability claims and other litigation liability.
• A breakdown or breach of our information technology systems could subject us to liability or interrupt the operation of our business.
• If our facilities were to experience a catastrophic loss, our operations would be seriously harmed.
• The use of social media platforms presents risks and challenges.
• Our stock price may fluctuate.
• Our quarterly operating results are subject to significant fluctuation.
• We expect that results from our clinical development activities and the clinical development activities of our competitors will continue to be released periodically, and may result in significant volatility in the price of our common stock.
• Changes in tax laws, regulations and treaties could affect our future taxable income.
• We may need to raise additional capital that may not be available.
• Future indebtedness could materially and adversely affect our financial condition, and the terms of our credit agreements impose restrictions on our business, reducing our operational flexibility and creating default risks.
• Issuances of additional shares of our common stock could cause the price of our common stock to decline.
• There can be no assurance that we will repurchase shares of common stock or that we will repurchase shares at favorable prices.
• We have adopted anti-takeover provisions and are subject to Massachusetts corporate laws that may frustrate any attempt to remove or replace our current management or effectuate a business combination involving Vertex.
• SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
• Issuer Repurchases of Equity Securities
• Drug Discovery and Development
• Net Income Attributable to Vertex
• Research and Development Expenses
• Sales, General and Administrative Expenses
• Other Non-Operating Income (Expense), Net
• LIQUIDITY AND CAPITAL RESOURCES
• Future Capital Requirements
• CONTRACTUAL COMMITMENTS AND OBLIGATIONS
• Research and Development Costs
• Collaborative Arrangements and Asset Acquisitions
• Other Funding Commitments
• CRITICAL ACCOUNTING POLICIES AND ESTIMATES
• RECENT ACCOUNTING PRONOUNCEMENTS
• Foreign Exchange Market Risk
• Opinion on Internal Control over Financial Reporting
• Definition and Limitations of Internal Control over Financial Reporting