Classification is based on semantic text similarity scoring and may include approximations. “No match” means no high-confidence textual match was found — not necessarily that a section was removed.
🟢 New in Current Filing
We rely on third parties to carry out our operations. Failure to maintain our third-party relationships or challenges at or with these third parties could materially harm our business.
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🟡 Modified
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 that could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
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🟡 Modified
We may face manufacturing, supply, and distribution difficulties, among other challenges, delays, or interruptions, including at our third-party providers.
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🟡 Modified
A variety of risks associated with operating in foreign countries could materially adversely affect our business.
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🟡 Modified
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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🟡 Modified
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.
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🟡 Modified
Our business has a substantial risk of product liability claims and other litigation liability.
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🟡 Modified
If we are unable to sustain and grow revenues from sales of our CF medicines, our business would be materially harmed and the market price of our common stock would likely decline.
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🟡 Modified
If we are unable to successfully develop and commercialize additional products, our business could be materially harmed.
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🟡 Modified
Our effective tax rate fluctuates, and changes in tax laws, regulations and treaties, unfavorable resolution to the tax positions we have taken or exposure to additional income tax liabilities could have a material impact on our future taxable income.
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🟡 Modified
Uncertainty over intellectual property in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes that are inherently costly and unpredictable.
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🟡 Modified
If we are not successful in commercializing CASGEVY, our revenue growth could be limited and our business could be materially harmed.
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🟡 Modified
Risks Related to Financial Results and Holding Our Common Stock
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🟡 Modified
Insurance coverage and reimbursement of cell and genetic therapies is uncertain.
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🟡 Modified
Risks Related to Supply, Manufacturing and Reliance on Third Parties
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🟡 Modified
If we are unable to successfully develop, obtain approval and commercialize treatments for acute and neuropathic pain, our business could be materially harmed.
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🟡 Modified
Risks Related to Our Operations
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