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
Changes to product reimbursement and coverage policies and practices may materially harm our business, prospects, operating results, and financial condition.
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🟢 New in Current Filing
Public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) have adversely affected and may in the future adversely affect our business.
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🔴 No Match in Current Filing
Our business may be further adversely affected by the effects of the COVID-19 pandemic.
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🔴 No Match in Current Filing
We may need additional funding in the future, which may not be available to us, and which may force us to delay, reduce or eliminate our product development programs or commercialization efforts.
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🔴 No Match in Current Filing
Risks Related to the COVID-19 Pandemic
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🔴 No Match in Current Filing
We face risks related to the development, manufacturing, and potential future commercialization of monoclonal antibodies targeting SARS-CoV-2.
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🔴 No Match in Current Filing
Our business is subject to increasingly complex corporate governance, public disclosure, and accounting requirements and regulations that could adversely affect our business, operating results, and financial condition.
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🟡 Modified
Changes in laws and regulations affecting the healthcare industry could adversely affect our business.
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🟡 Modified
Increasing use of social media and artificial intelligence-based platforms could give rise to liability, breaches of data security and privacy laws, or reputational damage.
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🔴 No Match in Current Filing
If we or our collaborators do not maintain regulatory approval for our marketed products, and obtain regulatory approval for our product candidates or new indications for our marketed products, we will not be able to market or sell them, which would materially and negatively impact our business, prospects, operating results, and financial condition.
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🔴 No Match in Current Filing
Many of our product candidates in development are recombinant proteins that could cause an immune response, resulting in the creation of harmful or neutralizing antibodies against the therapeutic protein.
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🟡 Modified
We face risks related to the personal data we collect, process, and share.
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🟡 Modified
Obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain. If we or our collaborators do not maintain regulatory approval for our marketed products, and obtain regulatory approval for our product candidates or new indications for our marketed products, we will not be able to market or sell them, which would materially and negatively impact our business, prospects, operating results, and financial condition.
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🟡 Modified
Other Risks Related to Our Business and Our Common Stock
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🟡 Modified
The commercial success of our products and product candidates is subject to significant competition.
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🟡 Modified
Risks associated with our operations outside the United States could adversely affect our business.
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🟡 Modified
Successful development of our current and future product candidates is uncertain.
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🟡 Modified
If our collaboration with Bayer for EYLEA HD and EYLEA is terminated, or Bayer materially breaches its obligations thereunder, our business, prospects, operating results, and financial condition, and our ability to continue to commercialize EYLEA HD and EYLEA outside the United States would be materially harmed.
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🟡 Modified
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.
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🟡 Modified
Sales of our marketed products are dependent on the availability and extent of coverage and reimbursement from third-party payors.
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🟡 Modified
We may incur additional tax liabilities related to our operations.
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🟡 Modified
If our Antibody Collaboration with Sanofi is terminated, or Sanofi materially breaches its obligations thereunder, our business, prospects, operating results, and financial condition, and our ability to develop, manufacture, and commercialize certain of our products and product candidates in the time expected, or at all, may be materially harmed.
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🟡 Modified
If we are unable to establish commercial capabilities outside the United States for Libtayo, Dupixent, and any other products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected.
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🟡 Modified
We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent.
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🟡 Modified
Risks Related to Our Reliance on or Transactions with Third Parties
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🟡 Modified
Changes in foreign currency exchange rates could have a material adverse effect on our operating results.
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🟡 Modified
Commercialization Risks
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