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.
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We conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could become subject to penalties, be excluded from participation in government programs, and/or be required to make significant changes to our operations.
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🟡 Modified
Sustainability (including environmental, social and governance) regulations, policies and provisions could expose us to numerous risks.
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🔴 No Match in Current Filing
We are subject to cost-containment efforts by third-party payors that could result in reduced product pricing and/or sales of our products and cause a reduction in revenue.
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🔴 No Match in Current Filing
Our CGM systems currently have regulatory marketing authorization limited to individual patient home-use, and have otherwise not received clearance or approval from the FDA or other regulators for use in hospital or other in-patient facility settings, although the FDA has advised us that it will not object to the use of our CGM systems in such settings during the COVID-19 pandemic. Our potential supply of our CGM systems for use in this environment during the COVID-19 pandemic may present risks to our business.
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🔴 No Match in Current Filing
The warrants related to the 2023 Notes and our common stock.
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🟡 Modified
If we experience decreasing prices for our products and we are unable to reduce our expenses, including the per unit cost of producing our products, there may be a material adverse effect on our business, results of operations, financial condition and cash flows.
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🟡 Modified
Our business could be negatively impacted by evolving expectations and challenges relating to implementing sustainability (including environmental, social and governance) initiatives, setting sustainability-related goals, collecting sustainability-related data, and disclosing sustainability-related information.
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🟡 Modified
If our manufacturing capabilities are insufficient to produce an adequate supply of product at appropriate quality levels, our growth could be limited and our business could be harmed.
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🟡 Modified
Failure to obtain any required regulatory authorization in international jurisdictions will prevent us from marketing our products abroad.
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🟡 Modified
Our products may not achieve or maintain market acceptance.
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🟡 Modified
Our Amended Credit Agreement imposes restrictions on us that may adversely affect our ability to operate our business.
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