Search every filing
2,477,667 paragraphs from 10-Ks, 10-Qs and 8-Ks with press releases.
Matching paragraphs
We face significant risks from the existing tariffs imposed by the United States (such as those discussed above) and potential new tariffs as well as their secondary effects, including other countries' imposition of retaliatory tariffs and non-tariff barriers. Depending on how the existing tariffs are applied and whether additional tariffs are imposed, our products that are manufactured partly or entirely outside of the United States could be subject to tariff duties when they are imported to the United States for further manufacturing, packaging, and/or sale to customers. In addition, like all U.S. importers, our Company could pay more for foreign-sourced inputs, which could adversely affect our operating costs in the United States. Our results of operations and financial condition may be materially adversely affected due to the impact of the foregoing.
Read in the filing ↗ Also in 10-Q of Oct 28, 2025, 10-K of Feb 4, 2026, 10-Q of Apr 29, 2026, 10-Q of Jul 30, 2026, 10-Q of Oct 30, 2026
The United States has recently imposed significant tariffs on imports from other countries, including a baseline tariff of 10% on imports into the United States and higher tariffs on multiple designated countries, such as "reciprocal" tariffs at varying rates. Such tariffs have prompted retaliatory measures from several countries, which may further escalate. Certain of these tariffs have been subsequently paused …
Read in the filing ↗ Also in 10-Q of Aug 1, 2025, 10-Q of Oct 28, 2025
On February 20, 2026, the U.S. Supreme Court ruled that IEEPA does not confer the authority to impose tariffs. In response, the U.S. administration ceased collecting these duties and, on February 24, 2026, imposed a 10% tariff on imports from all trading partners under Section 122 of the Trade Act of 1974 ("Section 122"). The United States has signaled an intention to raise the Section 122 tariff rate to the statutory maximum of 15%, but this has not materialized as of the date of this report. Additionally, pharmaceuticals and pharmaceutical ingredients have thus far been exempted from these tariffs.
Read in the filing ↗ Also in 10-Q of Oct 30, 2026, 10-Q of Jul 30, 2026
On July 23, 2026, USTR issued a notice of action in the Section 301 investigation into forced labor. As a result of this notice, tariffs of either 10% or 12.5%, effective July 24, 2026, apply to imports from 60 countries, including locations where we have operations, such as Canada, the European Union, India, Japan, and the United Kingdom. These tariffs essentially replace the 10% Section 122 surcharge that expired on July 24, 2026. USTR has provided a number of exemptions to the new tariffs, including exemptions for 700 specific articles used in pharmaceutical applications. While these exemptions limit the direct impact of the forced labor Section 301 tariffs on our import activities, some of our imports may not qualify for the exemptions and may be subject to the new tariffs. Additionally, because the scope, timing, and applicability of any tariffs resulting from the other ongoing Section 301 investigations remain uncertain, it is unclear what impact they may have on our supply chain and operations.
Read in the filing ↗ Also in 10-Q of Oct 30, 2026
In addition, on April 2, 2026, the United States imposed new tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients under Section 232, which are set to become effective on July 31, 2026. The Section 232 tariffs create a tiered structure with multiple rates depending on the country of origin, the importing company's status concerning onshoring and pricing agreements, and the nature of the product. The Section 232 tariffs implement all pharmaceutical-related
Read in the filing ↗
In 2025, the U.S. administration imposed an array of tariffs under the International Emergency Economic Powers Act ("IEEPA"). In July 2025, the United States and the EU announced the framework of a trade agreement that generally imposes a 15% tariff on imports from the EU. Under this agreement, pharmaceutical products would not be subject to any future duties under Section 232 in excess of this 15% rate. IEEPA tariffs prompted retaliatory measures from several countries.
Read in the filing ↗ Also in 10-Q of Apr 29, 2026, 10-Q of Jul 30, 2026
• changes in trade, economic, and other policies of the United States or other countries, such as the imposition or threat of tariffs (including tariffs that have been or may in the future be imposed by the United States or other countries), other trade barriers, or protectionist or retaliatory measures taken by the United States or other countries;
Read in the filing ↗ Also in 10-Q of Oct 28, 2025, 10-K of Feb 4, 2026, 10-Q of Apr 29, 2026, 10-Q of Jul 30, 2026, 10-Q of Oct 30, 2026
Our Company faces risks associated with tariffs and other trade protection measures (including tariffs that have been or may in the future be imposed by the United States or other countries), import or export licensing requirements, trade embargoes, sanctions (including those administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury), other
Read in the filing ↗ Also in 10-Q of Oct 28, 2025, 10-K of Feb 4, 2026, 10-Q of Apr 29, 2026, 10-Q of Jul 30, 2026, 10-Q of Oct 30, 2026
In addition, in April 2026, the United States imposed new tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients under Section 232, which are set to become effective for certain companies on July 31, 2026, and for others on September 29, 2026. The Section 232 tariffs create a tiered structure with multiple rates depending on the country of origin, the importing company's status concerning onshoring and pricing agreements, and the nature of the product. The Section 232 tariffs implement all pharmaceutical-related commitments in existing U.S. trade deals. As discussed under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Recent Developments -
Read in the filing ↗
• our ability to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions;
Read in the filing ↗ Also in 10-Q of Oct 28, 2025, 10-K of Feb 4, 2026, 10-Q of Apr 29, 2026, 10-Q of Jul 30, 2026, 10-Q of Oct 30, 2026
• Tax liabilities, tariffs and other trade restrictions, and other risks associated with our operations outside the United States could adversely affect our business.
Read in the filing ↗ Also in 10-Q of Oct 28, 2025, 10-K of Feb 4, 2026, 10-Q of Apr 29, 2026, 10-Q of Jul 30, 2026, 10-Q of Oct 30, 2026
We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial condition.
Read in the filing ↗ Also in 10-Q of Oct 28, 2025, 10-K of Feb 4, 2026, 10-Q of Apr 29, 2026, 10-Q of Jul 30, 2026, 10-Q of Oct 30, 2026
In addition, in April 2026, the United States announced new tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients under Section 232, which became effective for those companies that had not entered into a qualifying agreement with the U.S. government by September 29, 2026. The Section 232 tariffs create a tiered structure with multiple rates depending on the country of origin, the importing company's status concerning onshoring and pricing agreements, and the nature of the product. As discussed under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations - U.S. Government Agreements," we have entered into the U.S. Government Agreements and thus have exemptions from the Section 232 tariffs through January 2029, subject to certain conditions.
Read in the filing ↗
• tariffs (including tariffs that have been or may in the future be imposed by the United States or other countries), trade protection measures, import or export licensing requirements, trade embargoes, sanctions (including those administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury), other trade barriers (including further legislation or actions taken by the United States or other countries that restrict trade), and protectionist or retaliatory measures taken by the United States or other countries;
Read in the filing ↗
U.S. Government Agreements," we have entered into the U.S. Government Agreements and thus have exemptions from the Section 232 tariffs through January 2029, subject to certain conditions.
Read in the filing ↗
Since March 11, 2026, the Office of the U.S. Trade Representative ("USTR") has initiated four new investigations under Section 301 of the Trade Act of 1974 ("Section 301") covering forced labor in supply chains; industrial overcapacity; intellectual property protection and enforcement concerns; and underpayment for certain pharmaceutical products. These investigations collectively target nearly 80 countries. As described below, the forced labor investigation has already resulted in new tariffs, effective July 24, 2026, and the remaining investigations could result in additional new tariffs impacting our business.
Read in the filing ↗ Also in 10-Q of Oct 30, 2026
• tariffs, trade protection measures, import or export licensing requirements, trade embargoes, sanctions (including those administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury), other trade barriers (including further legislation or actions taken by the United States or other countries that restrict trade), and protectionist or retaliatory measures taken by the United States or other countries (discussed in greater detail below under "We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial condition");
Read in the filing ↗ Also in 10-Q of Oct 28, 2025, 10-K of Feb 4, 2026, 10-Q of Apr 29, 2026, 10-Q of Jul 30, 2026, 10-Q of Oct 30, 2026
The Office of the U.S. Trade Representative ("USTR") has initiated two new investigations under Section 301 of the Trade Act of 1974 ("Section 301"), one focused on industrial overcapacity and another on forced labor in supply chains. These investigations collectively target nearly eighty countries. The U.S. administration has signaled that duties imposed as a result of these investigations would replace the Section 122 tariffs when they expire in July 2026. It remains unclear if exemptions and carve-outs from Section 122 duties that currently exist for products, including pharmaceutical products, will be replicated in their entirety with respect to any future set of Section 301 tariffs.
Read in the filing ↗
commitments in existing U.S. trade deals. As discussed under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Recent Developments - U.S. Government Agreements," we have entered into the U.S. Government Agreements and thus have exemptions from the Section 232 tariffs through January 2029, subject to certain conditions.
Read in the filing ↗
• In April 2026, the Company announced agreements with the U.S. government pursuant to which the Company will provide certain of its products to the Medicaid program at or below prices benchmarked against a defined group of other developed countries (Most-Favored-Nation Pricing), price certain future medicines in the United States at or below Most-Favored-Nation Pricing, offer Praluent ® for direct patient purchase, and continue its large investment in domestic R&D and manufacturing capacity. Furthermore, Regeneron will not be subject to future U.S. government pricing mandates and will receive tariff relief for three years.
Read in the filing ↗
… Our ability or the ability of our collaborators or such other third parties to continue to engage these China-based suppliers or service providers for certain preclinical research programs and clinical development programs could be restricted due to geopolitical developments between the United States and China, including as a result of the escalation of tariffs or other trade restrictions or …
Read in the filing ↗
In April 2026, we announced agreements with the U.S. government (the "U.S. Government Agreements") pursuant to which we have agreed, among other matters, to provide certain of our products that we wholly own in the United States to the Medicaid program at or below prices benchmarked against a defined group of other developed countries ("Most-Favored-Nation Pricing"). We have also agreed to price certain future medicines in the United States at or below Most-Favored-Nation Pricing; to participate in a direct purchasing platform, TrumpRx.gov, that will allow eligible patients to purchase Praluent directly; and to provide our recently FDA-approved gene therapy Otarmeni™ for free in the United States. The U.S. Government Agreements further provide that Regeneron's products will not face tariffs as a result of the U.S. Department of Commerce's recent investigation under Section 232 of the Trade Expansion Act of 1962, as amended, through January 2029 so long as the Company continues its commitments to invest in manufacturing and research and development infrastructure in the United States.
Read in the filing ↗ Also in 10-Q of Jul 30, 2026, 10-Q of Oct 30, 2026
… Our ability or the ability of our collaborators or such other third parties to continue to engage these China-based suppliers or service providers for certain preclinical research programs and clinical development programs could be restricted due to geopolitical developments between the United States and China, including as a result of the escalation of tariffs or other trade restrictions or …
Read in the filing ↗ Also in 10-Q of Oct 30, 2026, 10-Q of Jul 30, 2026, 10-Q of Aug 1, 2025, 10-Q of Oct 28, 2025, 10-K of Feb 5, 2025
In April 2026, in response to the May 2025 executive order described above and a related letter that we and certain other pharmaceutical companies received from President Trump, we entered into the U.S. Government Agreements, pursuant to which we have agreed, among other matters, to provide certain of our products that we wholly own in the United States to the Medicaid program, and to price certain future medicines in the United States, at prices no greater than Most-Favored-Nation Pricing. The U.S. Government Agreements further provide that Regeneron's products will not face tariffs as a result of the investigation under Section 232 of the Trade Expansion Act of 1962, as amended ("Section 232"), through January 2029 so long as the Company continues its commitments to invest in manufacturing and research and development infrastructure in the United States. The U.S. Government Agreements will likely result, and any potential future agreements with government entities could also result, in reduced prices and reimbursement for certain of our current and future marketed products and may impact our results of operations. See Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations - U.S. Government Agreements."
Read in the filing ↗ Also in 10-Q of Apr 29, 2026, 10-Q of Jul 30, 2026
… commercialize Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to …
Read in the filing ↗ Also in 8-K of Aug 1, 2025, 8-K of Oct 28, 2025
… commercialize Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to …
Read in the filing ↗
… commercialize Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to …
Read in the filing ↗ Also in 8-K of Apr 29, 2026
… commercialize Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to …
Read in the filing ↗
… or commercialize Regeneron's Products and Regeneron's Product Candidates; Regeneron's ability to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; the ability of Regeneron's collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to …
Read in the filing ↗