16 unchanged sentences
• Sales of our products are dependent on the availability and extent of coverage and reimbursement or copay assistance from third-party payors and other third parties, including private payors and government programs such as Medicare and Medicaid.
−Removed: • Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors beyond our control, such as drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities.
+Added: • Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors (including those beyond our control), such as drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities or agreements we have entered into or may in the future enter into with the U.S.
+Added: government or other governmental authorities.
• The commercial success of our products is subject to significant competition from products or product candidates that may be superior to, or more established or cost effective than, our products or product candidates, including biosimilars.
42 unchanged sentences
Net product sales of these products have historically represented a substantial portion of our revenues, and we expect net sales of these products to continue to be a significant contributor to our revenues and operating results, with an increasing dependence on EYLEA HD relative to our historical dependence on EYLEA.
−Removed: For the three months ended March 31, 2026 and 2025, our aggregate EYLEA HD and EYLEA net product sales in the United States represented 26% and 34% of our total revenues, respectively.
−Removed: For the three months ended March 31, 2026, EYLEA HD U.S.
+Added: For the six months ended June 30, 2026 and 2025, our aggregate EYLEA HD and EYLEA net product sales in the United States represented 25% and 33% of our total revenues, respectively.
+Added: For the six months ended June 30, 2026, EYLEA HD U.S.
net product sales represented 55% of our aggregate EYLEA HD and EYLEA U.S.
net product sales.
−Removed: If we experience difficulty with the commercialization of EYLEA HD or EYLEA in the United States or if Bayer experiences any difficulty with the commercialization of EYLEA HD or EYLEA outside the United States, if EYLEA HD net product sales do not sufficiently offset any sustained decline of EYLEA net product sales in or outside the United States, or if we and Bayer are unable to maintain or obtain marketing approvals of these products (as applicable), we may experience a reduction in revenue and may not be able to stay profitable at the levels we previously achieved or at all, and our business, prospects, operating results, and financial condition may be materially harmed.
+Added: If we experience difficulty with the commercialization of EYLEA HD or EYLEA in the United States or if Bayer experiences any difficulty with the commercialization of EYLEA HD or EYLEA outside the United States beyond what has been experienced to date as described below, if EYLEA HD net product sales do not sufficiently offset any sustained decline of EYLEA net product sales in or outside the United States, or if we and Bayer are unable to maintain or obtain marketing approvals of these products (as applicable), we may experience a reduction in revenue and may not be able to stay profitable at the levels we previously achieved or at all, and our business, prospects, operating results, and financial condition may be materially harmed.
Commercialization of EYLEA HD and EYLEA in the United States and elsewhere is subject to significant competition (as described further below under " The commercial success of our products and product candidates is subject to significant competition "), which we expect to continue to increase in the future.
−Removed: For the three months ended March 31, 2026, EYLEA U.S.
−Removed: net product sales declined by 36% compared to the corresponding period in 2025 as a result of competitive pressures and other factors described under Part I, Item 2.
+Added: For the three and six months ended June 30, 2026, EYLEA U.S.
+Added: net product sales declined by 45% and 41%, respectively, compared to the corresponding periods in 2025 as a result of competitive pressures and other factors described under Part I, Item 2.
"Management's Discussion and Analysis of Financial Condition and Results of Operations – Results of Operations." Following the expiration of the U.S.
regulatory exclusivity period for EYLEA in May 2024, several biosimilar versions of EYLEA have been approved by the FDA, and one such product has launched in the United States.
−Removed: EYLEA and/or EYLEA HD net product sales recorded by us are likely to continue to be negatively impacted by biosimilar competition in the United States, including competition from additional biosimilar versions of EYLEA expected to launch in the United States in the second half of 2026, which may have a material adverse impact on our results of operations.
−Removed: In addition, we expect that competition for EYLEA and/or EYLEA HD outside the United States will continue to increase as biosimilar versions of EYLEA (including those already approved but not yet launched) are brought to market in additional countries, which may negatively impact the amount of collaboration revenue we earn from Bayer.
−Removed: While in the last six months the FDA approved EYLEA HD for the treatment of RVO and for additional dosing regimens and we continue to work toward FDA approval of the EYLEA HD pre-filled syringe as discussed under Part I, Item 1.
−Removed: "Business - Programs in Clinical Development - Additional Information - Clinical Development Programs - EYLEA HD," there can be no assurance that these
−Removed: enhancements (including potential FDA approval of the EYLEA HD pre-filled syringe) will help accelerate any potential future growth of EYLEA HD net product sales.
+Added: EYLEA and/or EYLEA HD net product sales recorded by us are likely to continue to be negatively impacted by biosimilar competition in the United States, including competition from additional biosimilar versions of EYLEA expected to launch in the United States in the near future, which may have a material adverse impact on our results of operations.
+Added: In addition, we expect that competition for EYLEA and/or EYLEA HD outside the United States will continue to increase as biosimilar versions of EYLEA (including those already approved but not yet launched) are brought to market in additional countries, which may continue to negatively impact the amount of collaboration revenue we earn from Bayer.
+Added: While the FDA recently approved EYLEA HD for the treatment of RVO and for additional dosing regimens and we continue to work toward FDA approval of the EYLEA HD pre-filled syringe as discussed under Part I, Item 2.
+Added: "Management's Discussion and
+Added: Analysis of Financial Condition and Results of Operations - Overview - Additional Information - Clinical Development Programs - EYLEA HD," there can be no assurance that these enhancements (including potential FDA approval of the EYLEA HD pre-filled syringe) will help accelerate any potential future growth of EYLEA HD net product sales.
The degree to which EYLEA HD net product sales may offset further potential decreases in EYLEA net product sales, resulting from the factors discussed above or otherwise, is uncertain.
We also are substantially dependent on our share of profits from the commercialization of Dupixent under our collaboration with Sanofi (the "Antibody Collaboration").
−Removed: For the three months ended March 31, 2026 and 2025, Sanofi collaboration revenue (most of which is attributable to our share of profits from the commercialization of Dupixent) represented 45% and 39% of our total revenues, respectively.
+Added: For the six months ended June 30, 2026 and 2025, Sanofi collaboration revenue (most of which is attributable to our share of profits from the commercialization of Dupixent) represented 48% and 39% of our total revenues, respectively.
If we or Sanofi were to experience any difficulty with the commercialization of Dupixent or if we or Sanofi are unable to maintain current marketing approvals of Dupixent, we may experience a reduction in revenue and our business, prospects, operating results, and financial condition may be materially harmed.
3 unchanged sentences
• sufficient coverage of, and reimbursement or copay assistance for, our marketed products by third-party payors and other third parties, including Medicare and Medicaid in the United States and other government and private payors in the United States and foreign jurisdictions, as well as U.S.
−Removed: and foreign payor restrictions on eligible patient populations and the reimbursement process (including drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities);
+Added: and foreign payor restrictions on eligible patient populations and the reimbursement process (including drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities or agreements we have entered into or may in the future enter into with the U.S.
+Added: government or other governmental authorities);
• our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical development;
15 unchanged sentences
If we or our collaborators fail to maintain regulatory compliance for any of such products, the applicable marketing approval may be withdrawn, which would materially harm our business, prospects, operating results, and financial condition.
−Removed: We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or they commercialize for the products' currently approved indications in the United States, EU, Japan, and other countries.
−Removed: If we or our collaborators fail to maintain regulatory compliance or satisfy other obligations for such products' currently approved indications (including because the product does not meet the relevant endpoints of any required post-approval studies (such as those required under an accelerated approval by the FDA or other similar type of approval), or for any of the reasons discussed below under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug and biological products is costly, time-consuming, and highly uncertain.
+Added: We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or they commercialize in the United States, EU, Japan, and other countries.
+Added: If we or our collaborators fail to maintain regulatory compliance or satisfy other obligations for such products (including because the product does not meet the relevant endpoints of any required post-approval studies (such as those required under an accelerated approval by the FDA or other similar type of approval), or for any of the reasons discussed below under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug and biological products is costly, time-consuming, and highly uncertain.
If we or our collaborators do not maintain regulatory approval for our marketed products, or obtain regulatory approval for our product candidates, we will not be able to market or sell them;
17 unchanged sentences
If independent not-for-profit patient assistance funds that provide patient copay assistance are unable to support eligible patients, this will likely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents.
−Removed: As our currently marketed products and most of our product candidates are biologics, bringing them to market may cost more than bringing traditional, small-molecule drugs to market due to the complexity associated with the research, development, production, supply, and regulatory review of such products.
−Removed: Given cost sensitivities in many healthcare systems, our currently
−Removed: marketed products and product candidates are likely to be subject to continued pricing pressures, which may have an adverse impact on our business, prospects, operating results, and financial condition.
+Added: As our currently marketed products and our product candidates are biologics, genetics medicines, peptides, or other complex therapeutics, bringing them to market may cost more than bringing traditional, small-molecule drugs to market due to the complexity associated with the research, development, production, supply, and regulatory review of such products.
+Added: sensitivities in many healthcare systems, our currently marketed products and product candidates are likely to be subject to continued pricing pressures, which may have an adverse impact on our business, prospects, operating results, and financial condition.
In addition, in order for private insurance and governmental payors (such as Medicare and Medicaid in the United States) to reimburse the cost of our marketed products, we must maintain, among other things, our FDA registration and our National Drug Code, formulary approval by PBMs, and recognition by insurance companies and Centers for Medicare & Medicaid Services ("CMS").
11 unchanged sentences
Our results of operations may suffer if we or our collaborators are unable to market our products in countries outside the United States or if coverage and reimbursement for our marketed products in such countries is limited or delayed.
−Removed: As discussed below under " If we are unable to establish sufficient commercial capabilities outside the United States for products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected, " we will need to manage these and other commercialization-related risks in order for us to successfully maintain and/or further develop sufficient commercial capabilities outside the United States.
+Added: As discussed below under " If we are unable to maintain or establish sufficient commercial capabilities outside the United States for products we currently commercialize or co-commercialize, or intend to commercialize or co-commercialize in the future, outside the United States, our business, prospects, operating results, and financial condition may be adversely affected, " we will need to manage these and other commercialization-related risks in order for us to successfully maintain and/or further develop sufficient commercial capabilities outside the United States.
Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors beyond our control, which may adversely impact our business, prospects, operating results, and financial condition.
12 unchanged sentences
The Medicare Drug Price Negotiation Program requires the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D.
−Removed: Starting in 2023 and 2026, the government is authorized to select Part D and Part B drugs, respectively, for inclusion in the Medicare Drug Price Negotiation Program, with established prices to go into effect for selected Part D drugs in 2026 and for selected Part B drugs in 2028, in each case absent certain disqualifying events.
+Added: Since 2023 and 2026, the government has been in the process of selecting Part D and Part B drugs, respectively, for inclusion in the Medicare Drug Price Negotiation Program, with established prices for the first cycle of selected Part D drugs having gone into effect at the beginning of 2026 and established prices for the first cycle of selected Part B drugs slated to go into effect in 2028, in each case absent certain disqualifying events.
• Medicare Inflation Based Rebates .
2 unchanged sentences
The IRA implements changes to the Medicare Part D benefits to limit patient out-of-pocket drug costs and shift program liabilities from patients to other stakeholders, including health plans, manufacturers, and the government.
−Removed: The full extent to which the policy changes described above will ultimately impact reimbursement levels of our marketed products, including those covered under Medicare Part B (such as EYLEA HD and EYLEA), or our product candidates that may be covered under Medicare Part B or Medicare Part D in the future, is currently unclear.
+Added: It is currently unclear whether and to what extent the Medicare Drug Price Negotiation Program or the other policy changes described above will ultimately impact reimbursement levels of our marketed products covered under Medicare Part B or Medicare Part D, or our product candidates that may be covered under Medicare Part B or Medicare Part D in the future.
In addition, the current U.S.
3 unchanged sentences
In addition, a prior executive order from April 2025 directed the HHS to take appropriate steps to, among other things, modify certain provisions of the Medicare Drug Price Negotiation Program, develop and implement a payment model to reduce the price of high-cost prescription drugs and biological products covered by Medicare, accelerate approval of generic and biosimilar products, and facilitate the ability of states to import pharmaceuticals from other countries.
−Removed: In response to these executive orders, in December 2025, the Center for Medicare and Medicaid Innovation proposed two mandatory Medicare payment models that, if finalized, would apply to certain drugs covered under Medicare Parts B and D and test whether alternative methodologies for calculating inflationary rebates based on international reference pricing would reduce Medicare spending.
−Removed: It is currently unclear how and to what extent the measures described in this paragraph may be implemented and what impact any such implementation would have on our Company.
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.
−Removed: 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 or below Most-Favored-Nation Pricing.
+Added: 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.
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.
6 unchanged sentences
A reduction in the availability or extent of reimbursement from U.S.
−Removed: government programs (including as a
−Removed: result of the legislation, proposals, initiatives, and developments described above) could have a material adverse effect on the sales of our marketed products.
+Added: government programs (including as a result of the legislation, proposals, initiatives, and developments described above) could have a material adverse effect on the sales of our marketed products.
Economic pressure on state budgets may also have a similar impact.
11 unchanged sentences
Novartis' Beovu ® (brolucizumab);
−Removed: and a biosimilar version of Lucentis commercialized in the United States by Biogen Inc.
+Added: and a biosimilar version of Lucentis commercialized in the United States by Harrow, Inc.
In addition, biosimilar versions of EYLEA have been approved and/or launched both in and outside the United States, including Amgen's Pavblu ™ (aflibercept-ayyh) in the United States.
We are aware of several other companies developing biosimilar versions of EYLEA, EYLEA HD, and/or other approved anti-VEGF treatments.
−Removed: We expect that biosimilar competition for EYLEA will continue to increase as additional biosimilar versions of EYLEA are launched in the United States and other countries, the timing of which will depend on, among other factors, the outcome of the pending patent litigation proceedings and the settlement terms of the previously pending litigation proceedings described in Note 12 to our Condensed Consolidated Financial Statements included in this report and the expiration of the patents protecting EYLEA (including those set forth under Part I - Item 1.
+Added: We expect that biosimilar competition for EYLEA will continue to increase as additional biosimilar versions of EYLEA are launched in the United States and other countries, the timing of which will depend on, among other factors, the outcome of the pending patent litigation proceedings and the settlement terms of the previously pending litigation proceedings (including those described in Note 12 to our Condensed Consolidated Financial Statements included in this report) and the expiration of the patents protecting EYLEA (including those set forth under Part I - Item 1.
"Business - Patents, Trademarks, and Trade Secrets" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (filed February 4, 2026)).
−Removed: Ophthalmologists are also using off-label, third-party repackaged versions of Genentech/Roche's approved VEGF antagonist, bevacizumab, for the treatment of certain of EYLEA HD's and EYLEA's respective indications, and we are aware of another company developing an ophthalmic formulation of such product that has been approved in the EU.
+Added: Ophthalmologists are also using off-label, third-party repackaged versions of Genentech/Roche's approved VEGF antagonist, bevacizumab, for the treatment of certain of EYLEA HD's and EYLEA's respective indications, and we are aware of another company with an ophthalmic formulation of such product that has been approved in the United States and the EU.
In DME and RVO, EYLEA HD and EYLEA also compete with intravitreal implants of corticosteroids.
14 unchanged sentences
Libtayo also faces significant competition.
−Removed: There are several competitors that are marketing and/or developing antibodies against PD-1 and/or PDL-1 (some of which were approved in the relevant indications and commercialized before
−Removed: Libtayo), including Merck's Keytruda ® (pembrolizumab), Bristol-Myers Squibb's Opdivo ® (nivolumab), Roche's Tecentriq ® (atezolizumab), AstraZeneca's Imfinzi ® (durvalumab), and Sun Pharma's Unloxcyt ™ (cosibelimab).
−Removed: While Libtayo is currently approved for intravenous administration only, certain of these products are also approved or in development for subcutaneous use.
+Added: There are several competitors that are marketing and/or developing antibodies against PD-1 and/or PDL-1 (some of which were approved in the relevant indications and commercialized before Libtayo), including Merck's Keytruda ® (pembrolizumab), Bristol-Myers Squibb's Opdivo ® (nivolumab), Roche's Tecentriq ® (atezolizumab), AstraZeneca's Imfinzi ® (durvalumab), and Sun Pharma's Unloxcyt ™ (cosibelimab).
+Added: While Libtayo is currently
+Added: approved for intravenous administration only, certain of these products are also approved or in development for subcutaneous use.
Other marketed products.
−Removed: There is also significant actual and potential future competition for other products marketed or otherwise commercialized by us and/or our collaborators under our collaboration agreements with them.
+Added: There is significant actual and potential future competition for other products marketed or otherwise commercialized by us and/or our collaborators under our collaboration agreements with them.
For example, Lynozyfic faces significant actual and potential future competition from other bispecific antibodies and CAR-T cell therapies targeting BCMA, GPRC5D, and/or other targets that are currently approved or in development for the treatment of relapsed/refractory multiple myeloma.
22 unchanged sentences
While we exercised our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States, we continue to rely in considerable part on Sanofi's sales and marketing organization in such jurisdictions.
−Removed: described in Note 12 to our Condensed Consolidated Financial Statements included in this report, we have sued Sanofi and certain of its affiliated entities (the "Antibody Collaboration Litigation") alleging that the defendants breached certain provisions of the agreement governing the Antibody Collaboration (the "Collaboration Agreement").
+Added: As described in Note 12 to our Condensed Consolidated Financial Statements included in this report, we have sued Sanofi and certain of its affiliated entities (the "Antibody Collaboration Litigation") alleging that the defendants breached certain
+Added: provisions of the agreement governing the Antibody Collaboration (the "Collaboration Agreement").
These provisions concern Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement.
26 unchanged sentences
We sell our marketed products for which we record net product sales in the United States to several distributors and specialty pharmacies, as applicable (collectively, "distributor customers"), which generally sell the product directly to healthcare providers or other pharmacies (as applicable).
−Removed: For the three months ended March 31, 2026 and 2025, our product sales to two distributor customers accounted on a combined basis for 75% and 76% of our total gross product revenue, respectively.
+Added: For each of the six months ended June 30, 2026 and 2025, our product sales to two distributor customers accounted on a combined basis for 76% of our total gross product revenue.
We expect significant distributor customer concentration to continue for the foreseeable future.
5 unchanged sentences
See also " The commercial success of our products and product candidates is subject to significant competition - Marketed Products" above.
−Removed: If we are unable to establish sufficient commercial capabilities outside the United States for products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected.
−Removed: While we have made progress with establishing commercial capabilities in certain jurisdictions outside the United States in recent years (primarily in connection with our acquisition of the worldwide rights to Libtayo in 2022 and the exercise of our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States), our commercial capabilities and experience with commercializing products outside the United States (as well as obtaining and/or maintaining regulatory approvals and securing pricing and reimbursement for our products outside the United States) are still somewhat limited.
−Removed: There may be other circumstances in which we need to establish further commercial capabilities outside the United States, including because we decide to commercialize other products independently (such as Lynozyfic and Ordspono, which we recently launched in the EU);
+Added: If we are unable to maintain or establish sufficient commercial capabilities outside the United States for products we currently commercialize or co-commercialize, or intend to commercialize or co-commercialize in the future, outside the United States, our business, prospects, operating results, and financial condition may be adversely affected.
+Added: While we have made progress with establishing commercial capabilities in certain jurisdictions outside the United States in recent years (primarily in connection with our acquisition of the worldwide rights to Libtayo in 2022), our commercial capabilities and experience with commercializing products outside the United States (as well as obtaining and/or maintaining regulatory approvals and securing pricing and reimbursement for our products outside the United States) are still somewhat limited.
+Added: There may be other circumstances in which we need to establish further commercial capabilities outside the United States, including because we decide to commercialize other products independently;
we are unable to find an appropriate collaborator;
34 unchanged sentences
While the FDA has performance goals that provide for action on NDA and BLA submissions by certain deadlines, the FDA's review goals are subject to change and the duration of the FDA's review depends on a number of factors, including the number and types of other applications that are submitted to the FDA around the same time period or are pending.
−Removed: The FDA's review of our regulatory submissions has in the past been delayed, and may be delayed in the future, due to the FDA's request for additional information or for other reasons, including those beyond our control (such a s the 2025 reduction and any future reductions of staffing or other resources at the FDA, as discussed further below).
+Added: The FDA's review of our regulatory submissions has in the past been delayed, and may be delayed in the future, due to the FDA's request for additional information or for other reasons, including those beyond our control (such a s recent changes in FDA leadership, the 2025 reduction in staffing at the FDA, and any future reductions of staffing or other resources at the FDA, as discussed further below).
The functioning of the FDA is affected by a variety of factors, such as shifting government priorities, budgets and funding levels, authorization and payment of user fees, the ability to hire and retain key personnel, as well as other statutory, regulatory, and policy changes impacting HHS, the FDA, or other HHS agencies.
policy changes have recently been implemented at a rapid pace, and additional changes may occur.
−Removed: For example, efforts implemented or commenced in 2025 to reduce the size and budgets of U.S.
−Removed: government agencies, downsize the federal workforce, and restructure parts of the executive branch of the federal government have directly or indirectly impacted agencies that support research and development activities or are otherwise important to our business, including the HHS and the FDA.
−Removed: If legislation, administrative action, or changes in policy prevent the FDA or other regulatory authorities from conducting routine inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to provide feedback on our clinical programs, meet with or engage in other informal interactions with us, and review and process our regulatory submissions (including our pending regulatory submissions) in a timely manner.
+Added: For example, there have been recent efforts to reduce the size and budgets of U.S.
+Added: government agencies, downsize the federal workforce, and restructure parts of the executive branch of the federal government.
+Added: These efforts have directly or indirectly impacted agencies that support research and development activities or are otherwise important to our business, including the HHS and the FDA.
+Added: There have also been ongoing senior leadership changes at the HHS and the FDA.
+Added: If legislation, administrative action, changes in policy, or the continued loss of experienced senior leadership and career staff prevent the FDA or other regulatory authorities from conducting routine inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to provide feedback on our clinical programs, meet with or engage in other informal interactions with us, and review and process our regulatory submissions (including our pending regulatory submissions) in a timely manner.
These developments may also reduce the FDA's capacity to engage in pre-approval or guidance meetings or meetings to negotiate labeling or post-marketing commitments.
−Removed: Furthermore, changes in FDA personnel and policy (such as the 2025 reductions in communication and policymaking roles) may negatively impact the transparency of agency actions, lead to modifications in FDA approval requirements, and alter the FDA's existing guidance pertinent to the development strategy for our products and product candidates.
+Added: Furthermore, changes in FDA personnel and policy (such as those referenced above) may negatively impact the transparency of agency actions, lead to modifications in FDA approval requirements and related FDA review and approval delays, and alter the FDA's existing guidance pertinent to the development strategy for our products and product candidates.
In addition, the U.S.
8 unchanged sentences
Application of this guidance and related rules to our product candidates may result in a delay of the FDA review and approval process despite any earlier beneficial regulatory designation such product candidates may have received.
−Removed: For example, in March 2024, the FDA issued CRLs concerning our BLA for odronextamab for the treatment of relapsed/refractory FL and DLBCL due to the enrollment status of confirmatory Phase 3 trials, which, along with the July 2025 CRL discussed below, has delayed any potential FDA approval of odronextamab.
+Added: For example, in March 2024, the FDA issued CRLs concerning our BLA for odronextamab for the treatment of relapsed/refractory FL and DLBCL due to the enrollment status of confirmatory Phase 3 trials, which, along with the July 2025 CRL discussed below, has delayed the potential FDA approval of odronextamab.
The FDA and comparable foreign regulatory authorities enforce Good Clinical Practice requirements ("GCPs") and other regulations and legal requirements through periodic inspections of trial sponsors, clinical research organizations ("CROs"), principal investigators, and trial sites.
9 unchanged sentences
We have recently received several CRLs from the FDA for regulatory submissions concerning our products or product candidates due to the FDA's findings from inspections at third-party manufacturers responsible for filling drug product.
−Removed: These include the July 2025 CRL concerning the BLA for odronextamab in relapsed/refractory FL, which has delayed further any potential FDA approval of odronextamab in this indication;
−Removed: and the October 2025 CRL concerning our regulatory application seeking approval of the EYLEA HD pre-filled syringe, which has delayed further any potential FDA approval of the EYLEA HD pre-filled syringe.
+Added: These include the July 2025 CRL concerning the BLA for odronextamab in relapsed/refractory FL, which has delayed further the potential FDA approval of odronextamab in this indication;
+Added: and the October 2025 CRL concerning our regulatory application seeking approval of the EYLEA HD pre-filled syringe, which has delayed further the potential FDA approval of the EYLEA HD pre-filled syringe.
For additional information, see "Risks Related to Manufacturing and Supply - Our or our collaborators' or contract manufacturers' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
10 unchanged sentences
From time to time, we may hold a product's marketing approval in a jurisdiction outside the United States where we have less experience and where our regulatory capabilities are more limited;
−Removed: for example, this is now the case for Libtayo in many jurisdictions outside the United States (including Europe and Japan) due to the transition under the Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi.
−Removed: In addition, actions by a regulatory agency in a country or region with respect to a product candidate may have an impact on the approval process for that product candidate in another country or
−Removed: Foreign regulatory authorities may ask for additional data in order to begin a clinical study, including Phase 3 clinical trials required to submit an MAA in the EU.
+Added: for example, this is now the case for Libtayo in many jurisdictions outside the United States (including Europe and Japan) due to our acquisition of the worldwide rights to Libtayo in 2022.
+Added: In addition, actions by a regulatory agency in a country or region with respect to a product candidate may have an impact on the approval process for that product candidate in another country or region.
+Added: Foreign regulatory authorities may ask for additional
+Added: data in order to begin a clinical study, including Phase 3 clinical trials required to submit an MAA in the EU.
In addition, such authorities often have the authority to require post-approval studies, such as a post-authorization safety study ("PASS") and/or a post-authorization efficacy study ("PAES"), which involve various risks similar to those described above.
14 unchanged sentences
and the failure of clinical investigators, trial monitors, contractors, consultants, or trial subjects to comply with the trial plan, protocol, or applicable regulations related to Good Laboratory Practice requirements ("GLPs") or GCPs.
+Added: Given the evolving standards of care for certain conditions, approval of a product candidate to treat such conditions may rely on clinical endpoints that are no longer fit-for-purpose, and there may not be a consensus between clinical trial sponsors (including us) and the FDA or other regulatory authorities as to which other endpoints are adequately validated as a substitute and should be sufficient as a basis for regulatory approval.
Certain of these risks may be exacerbated as we pursue development of drugs generated by means other than our established "Trap" or VelociSuite technologies, such as siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression.
2 unchanged sentences
For example, we and our collaborators are currently conducting and may in the future conduct or initiate clinical trials with sites in Russia, Ukraine, and/or Israel.
−Removed: While we currently do not expect the Russia-Ukraine war, Israel's armed conflicts with Iran, Lebanon, or Hamas, or related developments to have a significant impact on our ability to obtain results from clinical trials conducted by us or our collaborators, further escalation (whether in these countries or surrounding areas) may adversely affect our ability to adequately conduct certain clinical trials and maintain compliance with relevant protocols due to, among other reasons, the prioritization of hospital resources away from clinical trials, reallocation or evacuation of site staff and subjects, or as a result of government-imposed curfews, warfare, violence, or other governmental action or other events that restrict movement.
+Added: While we currently do not expect the Russia-Ukraine war, armed conflicts in the Middle East, or related developments to have a significant impact on our ability to obtain results from clinical trials conducted by us or our collaborators, further escalation (whether in these countries or surrounding areas) may adversely affect our ability to adequately conduct certain clinical trials and maintain compliance with relevant protocols due to, among other reasons, the prioritization of hospital resources away from clinical trials, reallocation or evacuation of site staff and subjects, or as a result of government-imposed curfews, warfare, violence, or other governmental action or other events that restrict movement.
These developments may also result in our inability to access sites for monitoring or to obtain data or samples from affected sites or patients going forward.
6 unchanged sentences
If preclinical testing yields unfavorable results, product candidates may not advance to clinical trials.
−Removed: The failure of clinical trials to demonstrate the safety and effectiveness of our clinical candidates for the desired indication(s) would preclude the successful development of those candidates for such indication(s), in which event our business, prospects, operating results, and financial condition may be materially harmed.
+Added: The failure of clinical trials to demonstrate the safety and effectiveness of our
+Added: clinical candidates for the desired indication(s) would preclude the successful development of those candidates for such indication(s), in which event our business, prospects, operating results, and financial condition may be materially harmed.
Furthermore, an increasing number of our products and product candidates (including Libtayo) are being studied in combination with agents and treatments developed by us or our collaborators.
10 unchanged sentences
Many companies in the biopharmaceutical industry, including our Company, have suffered significant setbacks in clinical trials, even after promising results had been obtained in earlier trials.
−Removed: For example, in May 2025, we and Sanofi announced that one of two Phase 3 trials evaluating itepekimab in adults who were former smokers with inadequately controlled COPD did not meet its primary endpoint.
+Added: For example, in May 2026, we announced that a Phase 3 trial evaluating fianlimab in combination with Libtayo in first-line metastatic melanoma did not reach statistical significance for its primary endpoint compared to pembrolizumab monotherapy.
In a number of instances, we have terminated the development of product candidates due to a lack of or only modest effectiveness and/or safety concerns, and clinical trials evaluating our product candidates have failed to meet the relevant endpoints.
16 unchanged sentences
Various illnesses, injuries, and discomforts have been reported from time-to-time during clinical trials of our product candidates and new indications for our marketed products.
−Removed: It is possible that as we test our drug candidates or new
−Removed: indications in larger, longer, and more extensive or complex clinical programs (including those evaluating combination therapies), or as use of these drugs becomes more widespread if they receive regulatory approval, illnesses, injuries, and discomforts that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients.
+Added: It is possible that as we test our drug candidates or new indications in larger, longer, and more extensive or complex clinical programs (including those evaluating combination therapies), or as use of these drugs becomes more widespread if they receive regulatory approval, illnesses, injuries, and discomforts that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients.
Many times, side effects are only detectable after investigational drugs are tested in large-scale, Phase 3 clinical trials or, in some cases, after they are made available to patients after approval.
18 unchanged sentences
The FDA has substantial discretion in the approval process and may either refuse to accept an application for substantive review or may form the opinion after review of an application that the application is insufficient to allow approval of a drug-delivery device.
−Removed: For example, in October 2025, the FDA issued a CRL for the regulatory application seeking approval of the EYLEA HD pre-filled syringe, which has delayed further any potential FDA approval of the EYLEA HD pre-filled syringe.
+Added: For example, in October 2025, the FDA issued a CRL for the regulatory application seeking approval of the EYLEA HD pre-filled syringe, which has delayed further the potential FDA approval of the EYLEA
+Added: HD pre-filled syringe.
There can be no assurance that FDA approval of the EYLEA HD pre-filled syringe will be obtained in the currently anticipated time frame or at all.
4 unchanged sentences
to conduct the studies and prepare related documentation required for approval or clearance by the applicable regulatory agencies;
−Removed: and to continue to meet the applicable regulatory and other requirements to maintain approval or
−Removed: clearance once it has been received.
+Added: and to continue to meet the applicable regulatory and other requirements to maintain approval or clearance once it has been received.
In addition, other parties may allege that our drug-delivery devices infringe patents or other intellectual property rights.
24 unchanged sentences
Similarly, such opposition proceedings are increasingly common in Europe and are costly to defend.
−Removed: For example, certain of our European patents, including those pertaining to EYLEA and Dupixent, are subject to opposition proceedings before the European Patent Office (the "EPO") and/or patent offices of various European countries (see Note 12 to our Condensed Consolidated Financial Statements included in this report for additional information).
+Added: For example, certain of our European patents, including those pertaining to EYLEA HD, EYLEA, and Dupixent, are subject to opposition proceedings before the European Patent Office (the "EPO") and/or patent offices of various European countries (see Note 12 to our Condensed Consolidated Financial Statements included in this report for additional information).
We have pending patent applications in the USPTO, the EPO, and the patent offices of other foreign jurisdictions, and it is likely that we will need to defend patents from challenges by others from time to time in the future.
5 unchanged sentences
Additionally, the United States' and other government actions related to Russia's invasion of Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia.
−Removed: These actions could result in abandonment or lapse of our
−Removed: patents or patent applications, resulting in partial or complete loss of patent rights in Russia.
+Added: These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia.
Further, a decree was adopted by the Russian government in 2022, allowing Russian companies and individuals to exploit inventions owned by patent holders from the United States without consent or compensation.
21 unchanged sentences
Squibb & Sons, and Ono Pharmaceutical to obtain a license under certain patents owned and/or exclusively licensed by one or more of these parties that includes the right to develop and sell Libtayo.
−Removed: If any licenses are required, we may not be able to obtain such licenses on commercially reasonable terms, if at all.
+Added: If any licenses are required, we may not be able to obtain such licenses on commercially reasonable
+Added: terms, if at all.
The failure to obtain any such license could prevent us from developing or commercializing any one or more of our products or product candidates, which could severely harm our business.
1 unchanged sentence
For example, under the Orphan Drug Act in the United States, if a product candidate with an orphan drug designation subsequently receives FDA approval for indication(s) within the scope of such designation, the product will be entitled to orphan drug exclusivity for such indication(s), barring the FDA from approving for seven years in such approved indication(s) another sponsor's application for a product candidate considered under the FDA regulations to be the same drug as the previously-approved drug with orphan drug exclusivity.
−Removed: This orphan drug exclusivity does not block approval of competing products intended for the orphan exclusivity-protected indication but containing a different active moiety or principal molecular structure, or containing the same active moiety or principal molecular structure
−Removed: but intended for a different indication.
+Added: This orphan drug exclusivity does not block approval of competing products intended for the orphan exclusivity-protected indication but containing a different active moiety or principal molecular structure, or containing the same active moiety or principal molecular structure but intended for a different indication.
Similarly, in the EU, a designated orphan drug is provided up to 10 years of market exclusivity in the orphan indication, during which time the EMA is generally precluded from accepting a MAA for a similar medicinal product.
14 unchanged sentences
The increased likelihood of generic and biosimilar competition has exacerbated the risk of loss of innovators' market exclusivity.
−Removed: It is also not possible to predict changes in United States regulatory law that might reduce drug or biological product regulatory exclusivity.
+Added: It is also not possible to predict changes in United States regulatory law that might reduce drug or biological product regulatory exclusivity and/or requirements to demonstrate biosimilarity.
Due to this risk, and uncertainties regarding patent protection, the length of market exclusivity for any particular product we currently or may in the future commercialize is inherently uncertain.
4 unchanged sentences
Similarly, as EYLEA biosimilars have also been recently launched in certain jurisdictions outside the United States, EYLEA no longer has market exclusivity in those jurisdictions.
−Removed: In addition, as EYLEA HD does not benefit from regulatory exclusivity in the United States, market exclusivity for EYLEA HD in the United States is based solely on our patent rights pertaining to this product (which are subject to the risks and uncertainties discussed above under " If we cannot protect the confidentiality of our trade secrets, or our patents or other means of defending our intellectual property are insufficient to protect our proprietary rights, our business and competitive position will be harmed.
+Added: In addition, as EYLEA HD does not benefit from regulatory exclusivity in the United States, market exclusivity for EYLEA HD
+Added: in the United States is based solely on our patent rights pertaining to this product (which are subject to the risks and uncertainties discussed above under " If we cannot protect the confidentiality of our trade secrets, or our patents or other means of defending our intellectual property are insufficient to protect our proprietary rights, our business and competitive position will be harmed.
Any future loss of market exclusivity for a product would likely negatively affect revenues from product sales of that product and thus our financial results and condition and could have a material negative impact on our business.
20 unchanged sentences
In addition, we may face difficulties or delays in developing or acquiring the necessary production equipment and technology to manufacture sufficient quantities of our product candidates at reasonable costs and in compliance with applicable regulatory requirements.
−Removed: The FDA and analogous foreign regulatory authorities must determine that any existing and expanded manufacturing facilities and any fill/finish activities conducted by us, our collaborators, or our contract manufacturers comply, or continue to comply, with cGMP requirements for both clinical and commercial production and license them, or continue to license them, accordingly, and such facilities must also comply with applicable environmental, safety, and other governmental permitting requirements.
−Removed: We may not successfully expand or establish sufficient manufacturing or any future fill/finish capabilities or manufacture our products in a cost-effective manner or in compliance with cGMPs and other regulatory requirements, and we and our collaborators or contract manufacturers may not be able to build or procure additional capacity in the required timeframe to meet commercial demand for our products (or product candidates if they receive regulatory approval) and to continue to meet the requirements of
−Removed: our clinical programs.
+Added: The FDA and analogous foreign regulatory authorities must determine that any existing and expanded manufacturing facilities and any fill/finish activities conducted by us, our collaborators, or our contract manufacturers comply, or continue to comply, with cGMP
+Added: requirements for both clinical and commercial production and license them, or continue to license them, accordingly, and such facilities must also comply with applicable environmental, safety, and other governmental permitting requirements.
+Added: We may not successfully expand or establish sufficient manufacturing or any future fill/finish capabilities or manufacture our products in a cost-effective manner or in compliance with cGMPs and other regulatory requirements, and we and our collaborators or contract manufacturers may not be able to build or procure additional capacity in the required timeframe to meet commercial demand for our products (or product candidates if they receive regulatory approval) and to continue to meet the requirements of our clinical programs.
This would interfere with our efforts to successfully commercialize our marketed products, and it could also delay or require us to discontinue one or more of our clinical development programs.
13 unchanged sentences
We and our collaborators and contract manufacturers would be unable to manufacture these materials if the relevant facility were to cease production due to regulatory requirements or actions, business interruptions, labor shortages or disputes, supply chain interruptions or constraints (including with respect to natural gas and other raw materials), contaminations, fire, climate change, natural disasters, acts of war or terrorism, or other problems.
−Removed: For example, during the first quarter of 2026, bulk manufacturing production at our facility in Limerick, Ireland was temporarily interrupted due to unanticipated facility repairs that commenced during the quarter.
+Added: For example, during the first and second quarters of 2026, bulk manufacturing production at our facility in Limerick, Ireland was temporarily interrupted due to unanticipated facility repairs that commenced during the first quarter of 2026.
See Part I, Item 2.
−Removed: "Management's Discussion and Analysis of Financial Condition and Results of Operations – Results of Operations – Operating Expenses" for more information, including the interruption's impact on our reported and future financial results.
−Removed: To date, this issue has not adversely impacted our product supply;
−Removed: however, there can be no assurance that this issue will be remediated fully in the currently anticipated time frame or that it will not adversely affect the supply of our products in the future.
+Added: "Management's Discussion and Analysis of Financial Condition and Results of Operations – Results of Operations – Operating Expenses" for more information, including the interruption's impact on our reported financial results.
Many of our products and product candidates are very difficult to manufacture.
−Removed: As our products and most of our product candidates are biologics, they require processing steps that are more difficult than those required for many other chemical pharmaceuticals.
+Added: As our currently marketed products and our product candidates are biologics, genetics medicines, peptides, or other complex therapeutics, they require processing steps that are more difficult than those required for many other chemical pharmaceuticals.
Accordingly, multiple steps are needed to control the manufacturing processes.
−Removed: Problems with these manufacturing processes, even minor deviations from the normal process or from the materials used in the manufacturing process (which may not be detectable by us or our collaborators in a timely manner), have led in the past and could lead in the future to product defects or manufacturing failures, resulting in lot failures, product recalls, product liability claims, and/or insufficient inventory.
+Added: Problems with these manufacturing processes, even minor deviations from the normal
+Added: process or from the materials used in the manufacturing process (which may not be detectable by us or our collaborators in a timely manner), have led in the past and could lead in the future to product defects or manufacturing failures, resulting in lot failures, product recalls, product liability claims, and/or insufficient inventory.
Also, the complexity of our manufacturing process may make it difficult, time-consuming, and expensive to transfer our technology to our collaborators or contract manufacturers.
1 unchanged sentence
In addition, we rely on certain third parties or our collaborators to perform filling, finishing, distribution, laboratory testing, and other services related to the manufacture of our marketed products and product candidates, and to supply various raw materials and other products.
−Removed: We would be unable to obtain these raw materials, other products, or services for an indeterminate period of time if any of these third parties were to cease or interrupt production or otherwise fail to supply these materials, products, or services to us for any reason, including due to regulatory requirements or actions (including recalls), adverse financial developments at or affecting the supplier, failure by the supplier to comply with cGMPs, contaminations, business interruptions, or labor shortages or disputes (in each case, including as a result of public health outbreaks, epidemics, or pandemics or other geopolitical developments, such as the armed conflict between Russia and Ukraine).
+Added: We would be unable to obtain these raw materials, other products, or services for an indeterminate period of time if any of these third parties were to cease or interrupt production or otherwise fail to supply these materials, products, or services to us for any reason, including due to regulatory requirements or actions (including recalls), adverse financial developments at or affecting the supplier, failure by the supplier to comply with cGMPs, contaminations, business interruptions, or labor shortages or disputes (in each case, including as a result of public health outbreaks, epidemics, or pandemics or other geopolitical developments, such as the armed conflicts between Russia and Ukraine and in the Middle East).
Regional or single-source dependencies may in some cases accentuate these risks.
For example, the pharmaceutical industry generally, and in some instances our Company or our collaborators or other third parties on which we rely, depend on China-based suppliers or service providers for certain raw materials, products and services, or other activities.
−Removed: 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 the recently enacted BIOSECURE Act.
+Added: 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 the BIOSECURE Act that was enacted into law in late 2025.
See also "Other Regulatory and Litigation Risks - 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 " below.
11 unchanged sentences
Any delay, interruption, or other issue that arises in the manufacture, fill/finish, packaging, or storage of any drug product or product candidate as a result of a failure of our facilities or the facilities or operations of our collaborators, contract manufacturers, or other third parties to pass any regulatory agency inspection or maintain cGMP compliance could significantly impair our ability to develop, obtain approval for, and successfully commercialize our products, which would substantially harm our business, prospects, operating results, and financial condition.
−Removed: Any finding of non-compliance could also increase our costs, cause us to delay the development of our product candidates, result in delay in our obtaining, or our not obtaining, regulatory approval of product candidates or new indications for our marketed products, and cause us to lose revenue from any marketed products, which could be seriously detrimental to our business, prospects, operating results, and financial condition.
−Removed: We recently received several CRLs from the FDA for regulatory submissions concerning our products or product candidates due to the FDA's findings from inspections at third-party manufacturers responsible for filling drug product, as discussed above under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug
−Removed: and biological products is costly, time-consuming, and highly uncertain.
+Added: Any finding of non-compliance could also increase our costs, cause us to delay the development of our product candidates, result in delay in our obtaining, or our not obtaining, regulatory approval of product candidates or new indications for our marketed products, and cause us to lose revenue from any
+Added: marketed products, which could be seriously detrimental to our business, prospects, operating results, and financial condition.
+Added: We recently received several CRLs from the FDA for regulatory submissions concerning our products or product candidates due to the FDA's findings from inspections at third-party manufacturers responsible for filling drug product, as discussed above under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug and biological products is costly, time-consuming, and highly uncertain.
If we or our collaborators do not maintain regulatory approval for our marketed products, or obtain regulatory approval for our product candidates, we will not be able to market or sell them;
17 unchanged sentences
The FDA's review of promotional activities includes healthcare provider-directed and direct-to-consumer ("DTC") advertising, certain communications regarding unapproved uses, industry-sponsored scientific and educational activities, and sales representatives' communications.
−Removed: The current U.S.
−Removed: administration, HHS, and FDA have recently announced an initiative intended to ensure transparency and accuracy in DTC prescription drug advertisements through a series of reforms that have included and are expected to continue to include FDA rulemaking, additional enforcement action, and expanded regulatory oversight of social media promotional activities.
+Added: In 2025, the current U.S.
+Added: administration, HHS, and FDA announced an initiative intended to ensure transparency and accuracy in DTC prescription drug advertisements through a series of reforms that have included and are expected to continue to include FDA rulemaking, additional enforcement action, and expanded regulatory oversight of social media promotional activities.
Failure to comply with applicable FDA requirements for advertising and promotional activities (including those that currently apply or may apply in the future to DTC advertising) may subject a company to adverse enforcement action by the FDA, the Department of Justice, or the Office of the Inspector General of HHS, as well as state authorities.
6 unchanged sentences
If we provide payments or other remuneration to a healthcare professional to induce the prescribing of our products, we could face liability under state and federal anti-kickback laws.
−Removed: The federal civil False Claims Act prohibits any person from, among other things, knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid.
+Added: The federal civil False Claims Act prohibits any person from, among other things, knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement
+Added: to get a false claim paid.
The False Claims Act also permits a private individual acting as a "whistleblower" to bring actions on behalf of the federal government alleging violations of the statute and to share in any monetary recovery.
Pharmaceutical companies have been investigated and/or prosecuted under these laws for a variety of alleged promotional and marketing activities, such as allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product;
−Removed: reporting to pricing services inflated average wholesale prices that were then used by federal
−Removed: programs to set reimbursement rates;
+Added: reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates;
engaging in promotion for uses that the FDA has not approved, known as off-label uses, that caused claims to be submitted to Medicaid for non-covered off-label uses;
27 unchanged sentences
Price recalculations also may affect the ceiling price at which we are required to offer our products under the 340B program.
−Removed: Civil monetary penalties can be applied if we fail to pay the required rebate, if we are found to have knowingly submitted any false price or product information to the government, if we are found to have made a misrepresentation in the reporting of our average sales price, if we fail to submit the required price data on a timely basis, or if we are found to have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price.
+Added: Civil monetary penalties can be applied if we fail to pay the required rebate, if we are found to have knowingly submitted any false price or product information to the government, if we are found to have made a misrepresentation in the reporting of our
+Added: average sales price, if we fail to submit the required price data on a timely basis, or if we are found to have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price.
CMS could also decide to terminate our Medicaid drug rebate agreement, or HRSA could decide to terminate our 340B program participation agreement, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.
Our failure to comply with our reporting and payment obligations under the Medicaid Drug Rebate program and other governmental programs could negatively impact our operating results.
−Removed: In September 2024, CMS modified the regulations governing the Medicaid Drug Rebate program, which could further increase our costs and the complexity of compliance, impact rebate liabilities, and be time-consuming to implement.
Other regulations and coverage expansion by various governmental agencies relating to the Medicaid Drug Rebate program may have a similar impact.
26 unchanged sentences
There is no certainty that all of our employees, agents, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws.
−Removed: Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and
−Removed: prohibitions on the conduct of our business.
+Added: Violations of
+Added: these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business.
Any such violations could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our ability to expand internationally, our ability to attract and retain employees, and our business, prospects, operating results, and financial condition.
11 unchanged sentences
As described above, the PPACA and potential regulations thereunder easing the entry of competing follow-on biologics into the marketplace, other new legislation or implementation of existing statutory provisions on importation of lower-cost competing drugs from other jurisdictions, and legislation on comparative effectiveness research are examples of previously enacted and possible future changes in laws that could adversely affect our business.
−Removed: In addition, in 2023, the European Commission published a proposal to replace the current pharmaceutical legislative framework in the EU.
−Removed: While it is uncertain whether such proposal will be adopted in its current form, there may ultimately be a number of changes to the current regulatory framework in the EU, including a reduction of the data protection and market exclusivity periods provided thereby.
+Added: In addition, it is expected that in 2026 the revised EU pharmaceutical legislative framework will be adopted and enter into force, with a transition regime until 2028.
+Added: The revised EU legislative framework is expected to facilitate earlier generic and biosimilar market entry, including by generally reducing regulatory data protection and market exclusivity periods.
federal or state governments could carry out other significant changes in legislation, regulation, or government policy, including with respect to government reimbursement changes or drug price control measures or the PPACA or other healthcare reform laws.
13 unchanged sentences
We have operations and conduct business in many countries outside the United States and have been significantly expanding the scope of these activities in existing and/or additional countries, including EU countries and Japan.
−Removed: For example, as discussed above, we now have commercial presence in many jurisdictions outside the United States in connection with our commercialization of Libtayo and co-commercialization of Dupixent, and we expect this commercial presence to continue to increase as we expand our commercialization activities for other products outside the United States (including Lynozyfic and Ordspono, which recently launched in the EU).
+Added: For example, as discussed above, we now have commercial presence in many jurisdictions outside the United States, and we expect this commercial presence to continue to increase as we expand our commercialization activities for other products outside the United States.
Consequently, we are, and will continue to be, subject to risks related to operating in countries outside the United States, particularly those in which we have not previously established operations, and many of these risks will increase as we expand our activities in such jurisdictions.
3 unchanged sentences
Bribery Act (discussed in greater detail above under " Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition "), as well as labor and employment laws and regulations;
−Removed: • changes in the political or economic condition of a specific country or region, including as a result of the Russia-Ukraine war, or Israel's armed conflicts with Iran, Lebanon, or Hamas;
+Added: • changes in the political or economic condition of a specific country or region, including as a result of the Russia-Ukraine war, or armed conflicts in the Middle East;
• fluctuations in the value of foreign currency versus the U.S.
16 unchanged sentences
In response, the U.S.
−Removed: 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").
−Removed: 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.
−Removed: Additionally, pharmaceuticals and pharmaceutical ingredients have thus far been exempted from these tariffs.
−Removed: 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.
+Added: administration ceased collecting these duties and, on February 24, 2026, imposed a temporary 10% surcharge on imports from all trading partners under Section 122 of the Trade Act of 1974 ("Section 122").
+Added: This surcharge expired on July 24, 2026.
+Added: 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.
−Removed: The Section 232 tariffs implement all pharmaceutical-related
−Removed: commitments in existing U.S.
+Added: The Section 232 tariffs implement all pharmaceutical-related commitments in existing U.S.
As discussed under Part I, Item 2.
−Removed: "Management's Discussion and Analysis of Financial Condition and Results of Operations – Recent Developments – U.S.
+Added: "Management's Discussion and Analysis of Financial Condition and Results of Operations – Recent Developments –
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.
−Removed: The Office of the U.S.
−Removed: 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.
−Removed: These investigations collectively target nearly eighty countries.
−Removed: administration has signaled that duties imposed as a result of these investigations would replace the Section 122 tariffs when they expire in July 2026.
−Removed: 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.
+Added: Since March 11, 2026, the Office of the U.S.
+Added: 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;
+Added: industrial overcapacity;
+Added: intellectual property protection and enforcement concerns;
+Added: and underpayment for certain pharmaceutical products.
+Added: These investigations collectively target nearly 80 countries.
+Added: 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.
+Added: On July 23, 2026, USTR issued a notice of action in the Section 301 investigation into forced labor.
+Added: 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.
+Added: These tariffs essentially replace the 10% Section 122 surcharge that expired on July 24, 2026.
+Added: USTR has provided a number of exemptions to the new tariffs, including exemptions for 700 specific articles used in pharmaceutical applications.
+Added: 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.
+Added: 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.
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.
11 unchanged sentences
For example, the OECD Pillar Two framework has influenced tax laws in countries in which we operate, including the implementation of minimum taxes.
−Removed: Changes to these or other laws and regulations or their interpretations, including those resulting from the "One Big Beautiful Bill Act" signed into law in July 2025 (as discussed further in Note 8 to our Condensed Consolidated Financial Statements included in this report), could materially adversely impact our effective tax rate or cash flows.
+Added: Changes to these or other laws and regulations or their interpretations, including those resulting from the "One Big Beautiful Bill Act" signed into law in 2025, could materially adversely impact our effective tax rate or cash flows.
We face risks related to the personal data we collect, process, and share.
5 unchanged sentences
At the federal level, most U.S.
−Removed: healthcare providers, including research institutions from which we or our collaborators obtain clinical trial data, are subject to privacy and security regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA").
+Added: healthcare providers, including research institutions from which we or our collaborators obtain clinical trial data, are subject to privacy and security regulations promulgated under the Health Insurance Portability and Accountability Act of 1996
While Regeneron is not directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we could be subject to criminal penalties if we, our affiliates, or our agents knowingly receive protected health information in a manner that is not permitted under HIPAA.
2 unchanged sentences
The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records.
−Removed: Enforcement by the
−Removed: FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or enforcement actions.
+Added: Enforcement by the FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or enforcement actions.
In addition, at the state level, many state consumer privacy laws recently went into effect and many other consumer privacy laws are expected to go into effect in the near future.
12 unchanged sentences
The misuse of social media platforms by our employees or third parties on which we rely in contravention of our social media policy or other legal or contractual requirements may give rise to liability, lead to the loss of trade secrets or other intellectual property, or result in public exposure of sensitive data.
−Removed: Furthermore, negative posts or comments about us or our products in social media could seriously damage our reputation, brand image, and goodwill.
+Added: Social media posts may also include statements about efficacy or adverse events related to our products or product candidates that could create reporting obligations or lead to regulatory scrutiny.
+Added: Furthermore, negative, inaccurate, or misleading posts or comments about us or our products on social media or any online platform, including posts or comments generated using artificial intelligence ("AI"), could seriously damage our reputation, brand image, and goodwill.
There are inherent risks related to our increasing use of artificial intelligence-based solutions.
−Removed: We are increasingly utilizing artificial intelligence ("AI")-based solutions in various facets of our operations and continue to explore further use cases for AI.
+Added: We are increasingly utilizing AI-based solutions in various facets of our research, development, and other operations and continue to explore further use cases for AI.
The use of AI solutions by our employees or third parties on which we rely may lead to the impermissible use or public disclosure of sensitive data.
+Added: AI systems may generate inaccurate, incomplete, misleading, or biased outputs that may not be readily detectable by users, or may produce unreliable outputs over time.
+Added: Reliance on such outputs could result in errors, inefficiencies, compliance issues, or other adverse consequences.
+Added: Employee use of unapproved AI tools could create ungoverned data flows, unmonitored compliance gaps, and data protection risks that are not visible until an adverse event occurs.
+Added: In addition, the increasing use of agentic and autonomous AI systems may create additional operational, cybersecurity, compliance, and data protection risks.
+Added: Failures in the design, governance, or monitoring of such systems could result in unauthorized actions, inaccurate and/or biased outputs, disruption of business processes, or unauthorized access to sensitive information.
In the United States and in many jurisdictions outside the United States, new regulations have recently passed or have been proposed to ensure the ethical use, privacy, and security of AI solutions and the data processed thereby.
1 unchanged sentence
The misuse of AI solutions could also result in unauthorized access and use of personal data of our employees, clinical trial participants, collaborators, or other third parties.
+Added: Additionally, AI-assisted analysis or AI-generated content embedded in regulatory submissions may be challenged or require additional justification if the underlying methodology cannot be fully defended or if applicable regulatory guidance evolves.
Any of these events could have a material adverse effect on our business, prospects, operating results, and financial condition and could adversely affect the price of our Common Stock.
2 unchanged sentences
We rely on support from Sanofi to develop, manufacture, and commercialize certain of our products and product candidates.
−Removed: With respect to the products and product candidates that we are co-developing with Sanofi under our Antibody Collaboration (currently consisting of Dupixent, Kevzara, and itepekimab), Sanofi initially funds a significant portion of development expenses incurred in connection with the development of these products and product candidates.
+Added: With respect to the products and product candidates that we are co-developing with Sanofi under our Antibody Collaboration, Sanofi initially funds a portion of development expenses incurred in connection with the development of these products and product candidates.
In addition, we rely on Sanofi to lead much of the clinical development efforts, assist with or lead efforts to obtain and maintain regulatory approvals, and lead the commercialization efforts for these products and product candidates.
4 unchanged sentences
It is not possible to determine what impact (if any) the Antibody Collaboration Litigation may have on the Antibody Collaboration and our business relationship with Sanofi, or whether we will be successful in the Antibody Collaboration Litigation.
−Removed: While we have some commercial presence outside the United States, our commercial capabilities outside the United States are still limited and would need to be further developed or outsourced for products commercialized under our Antibody Collaboration (see also "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - If we are unable to establish sufficient commercial capabilities outside the United States for products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected " above).
+Added: While we have some commercial presence outside the United States, our commercial capabilities outside the United States are still limited and would need to be further developed or outsourced for products commercialized under our Antibody Collaboration (see also "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - If we are unable to maintain or establish sufficient commercial capabilities outside the United States for products we currently commercialize or co-commercialize, or intend to commercialize or co-commercialize in the future, outside the United States, our business, prospects, operating results, and financial condition may be adversely affected " above).
Termination of the Antibody Collaboration may create substantial new and additional risks to the successful development and commercialization of the products and product candidates subject to such collaborations, particularly outside the United States.
6 unchanged sentences
If Bayer were to terminate its collaboration agreement with us, we may not have the resources or skills to replace those of our collaborator, which could require us to seek another collaboration that might not be available on favorable terms or at all, and could cause significant issues for the commercialization of EYLEA HD and EYLEA outside the United States and result in substantial additional costs and/or lower revenues to us.
−Removed: We have limited commercial capabilities outside the United States and would have to develop or outsource these capabilities (see also "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - If we are unable to establish sufficient commercial capabilities outside the United States for products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected " above).
+Added: We have limited commercial capabilities outside the United States and would have to develop or outsource these capabilities (see also "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - If we are unable to maintain or establish sufficient commercial capabilities outside the United States for products we currently commercialize or co-commercialize, or intend to commercialize or co-
+Added: commercialize in the future, outside the United States, our business, prospects, operating results, and financial condition may be adversely affected " above).
Termination of the Bayer collaboration agreement would create substantial new and additional risks to the successful commercialization of EYLEA HD and EYLEA.
5 unchanged sentences
We and our collaborators rely on third-party service providers to support the distribution of our marketed products and for many other related activities in connection with the commercialization of these marketed products.
−Removed: Despite our or our
−Removed: collaborators' arrangements with them, these third parties may not perform adequately.
+Added: Despite our or our collaborators' arrangements with them, these third parties may not perform adequately.
If these service providers do not perform their services adequately, sales of our marketed products will suffer.
51 unchanged sentences
or globally), which could have a material adverse effect on our business, prospects, operating results, and financial condition.
−Removed: The foregoing risks may be exacerbated as we periodically upgrade or enhance our information technology systems.
+Added: The foregoing risks may be exacerbated as we periodically upgrade or enhance our information technology systems, including as part of our broader digital transformation efforts.
For example, we are in the early stages of a multi-year project to implement a new enterprise resource planning ("ERP") system.
Upgrading or implementing new business processes and information technology systems, including our new ERP system, requires the commitment of significant personnel, training, and financial resources, and includes risks to our business operations.
−Removed: If we do not successfully implement our new ERP system or other information technology systems improvements, or if there are delays or difficulties in implementing these systems, we may not realize anticipated productivity improvements or cost efficiencies, and we may experience operational difficulties and challenges in effectively managing our business, any of which could have a material adverse effect on our business, prospects, operating results, and financial condition.
+Added: If we do not successfully implement our new systems or other information technology systems improvements, or if there are delays or difficulties in implementing these systems, we may not realize anticipated productivity improvements or cost efficiencies, and we may experience operational difficulties and challenges in effectively managing our business, any of which could have a material adverse effect on our business, prospects, operating results, and financial condition.
Public health outbreaks, epidemics, or pandemics have adversely affected and may in the future adversely affect our business.
6 unchanged sentences
We have certain indebtedness and contingent liabilities, including milestone and royalty payment obligations.
−Removed: As of March 31, 2026, we had an aggregate of $2.706 billion of outstanding indebtedness under our senior unsecured notes and the lease financing facility.
+Added: As of June 30, 2026, we had an aggregate of $2.707 billion of outstanding indebtedness under our senior unsecured notes and the lease financing facility.
We may also incur additional debt in the future.
11 unchanged sentences
Our investments are subject to risks and other external factors that may result in losses or affect the liquidity of these investments.
−Removed: As of March 31, 2026, we had $2.963 billion in cash and cash equivalents and $16.319 billion in marketable and other securities (including $790.2 million in equity securities).
+Added: As of June 30, 2026, we had $2.456 billion in cash and cash equivalents and $16.168 billion in marketable and other securities, as further described in Note 5 and Note 6 to our Condensed Consolidated Financial Statements included in this report.
Our investments consist primarily of debt securities, including investment-grade corporate bonds.
1 unchanged sentence
The equity securities we hold may experience significant volatility and may decline in value or become worthless if the issuer experiences an adverse development.
−Removed: Furthermore, our equity investments could be subject to dilution (and decline in value) as a result of the issuance of additional equity interests by the applicable issuer.
+Added: Furthermore, our equity investments could be subject to dilution (and decline in value) as a result of the issuance of additional
+Added: equity interests by the applicable issuer.
If any of our investments suffer market price declines, such declines may have an adverse effect on our financial condition and operating results.
37 unchanged sentences
Securities class action litigation is often initiated against companies following periods of volatility in their stock price.
−Removed: For example, in January 2025, a putative class action civil complaint was filed against the Company and certain current and former executive officers of the Company asserting violations of federal securities laws, as further described in Note 12 to our Condensed Consolidated Financial Statements included in this report.
−Removed: This type of litigation could result in
−Removed: substantial costs and divert our management's attention and resources, and could also require us to make substantial payments to satisfy judgments or to settle litigation, which may harm our business, prospects, operating results, and financial condition.
+Added: For example, in July 2026, a putative class action civil complaint was filed against the Company and certain employees of the Company asserting violations of federal securities laws, as further described in Note 12 to our Condensed Consolidated Financial Statements included in this report.
+Added: This type of litigation could result in substantial costs and divert our management's attention and resources, and could also require us to make substantial payments to satisfy judgments or to settle litigation, which may harm our business, prospects, operating results, and financial condition.
Future sales of our Common Stock by our significant shareholders or us may depress our stock price and impair our ability to raise funds in new share offerings.
A small number of our shareholders beneficially own a substantial amount of our Common Stock.
−Removed: As of April 14, 2026, our five largest shareholders plus Dr.
−Removed: Schleifer, our Chief Executive Officer, beneficially owned approximately 32.0% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of April 14, 2026.
+Added: As of June 30, 2026, our five largest shareholders plus Dr.
+Added: Schleifer, our Chief Executive Officer, beneficially owned approximately 31.3% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of June 30, 2026.
If our significant shareholders or we sell substantial amounts of our Common Stock in the public market, or there is a perception that such sales may occur, the market price of our Common Stock could fall.
1 unchanged sentence
There can be no assurance that we will continue to repurchase shares of our Common Stock or continue to declare cash dividends.
−Removed: In February 2025, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock (of which $688.2 million remained available as of March 31, 2026);
−Removed: and, in April 2026, the board authorized an additional $3.0 billion for share repurchases.
+Added: In April 2026, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock (of which $2.534 billion remained available as of June 30, 2026).
In 2025, our board of directors also initiated a quarterly cash dividend program.
4 unchanged sentences
Holders of Class A Stock, who are generally the shareholders who purchased their stock from us before our initial public offering, are entitled to ten votes per share, while holders of Common Stock are entitled to one vote per share.
−Removed: As of April 14, 2026, holders of Class A Stock held 15.0% of the combined voting power of all shares of Common Stock and Class A Stock then outstanding.
+Added: As of June 30, 2026, holders of Class A Stock held 15.2% of the combined voting power of all shares of Common Stock and Class A Stock then outstanding.
These shareholders, if acting together, would be in a position to substantially influence the election of our directors and the vote on certain corporate transactions that require majority or supermajority approval of the combined classes, including mergers and other business combinations.
This may result in our taking corporate actions that other shareholders may not consider to be in their best interest and may affect the price of our Common Stock.
−Removed: As of April 14, 2026:
−Removed: • our current executive officers and directors beneficially owned 5.2% of our outstanding shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and the exercise of all options and release of all restricted stock units held by such persons which are exercisable or releasable within 60 days of April 14, 2026, and 17.5% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options and release of all restricted stock units held by such persons which are exercisable or releasable within 60 days of April 14, 2026;
+Added: As of June 30, 2026:
+Added: • our current executive officers and directors beneficially owned 5.3% of our outstanding shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and the exercise of all options and release of all restricted stock units held by such persons which are exercisable or releasable within 60 days of June 30, 2026, and 17.7% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options and release of all restricted stock units held by such persons which are exercisable or releasable within 60 days of June 30, 2026;
• our five largest shareholders plus Dr.
−Removed: Schleifer, our Chief Executive Officer, beneficially owned approximately 32.0% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of April 14, 2026.
−Removed: In addition, these five shareholders plus our Chief Executive Officer held approximately 40.4% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of April 14, 2026.
+Added: Schleifer, our Chief Executive Officer, beneficially owned approximately 31.3% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of June 30, 2026.
+Added: In addition, these five shareholders plus our Chief Executive Officer held approximately 39.9% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of June 30, 2026.
The anti-takeover effects of provisions of our charter, by-laws, and of New York corporate law, as well as the contractual provisions in our investor and collaboration agreements and certain provisions of our compensation plans and agreements, could deter, delay, or prevent an acquisition or other "change of control" of us and could adversely affect the price of our Common Stock.
4 unchanged sentences
• authorization to issue "blank check" preferred stock, which is preferred stock that can be created and issued by the board of directors without prior shareholder approval, with rights senior to those of our Common Stock and Class A Stock;
−Removed: • a staggered board of directors (which, pursuant to an amendment to our certificate of incorporation approved by shareholders in 2025, will be phased out beginning in 2026 and result in the annual election of all of our directors commencing with the 2028 annual meeting of shareholders);
+Added: • a staggered board of directors (which, pursuant to an amendment to our certificate of incorporation approved by shareholders in 2025, is in the process of being phased out, resulting in the annual election of all of our directors commencing with the 2028 annual meeting of shareholders);
• a requirement that removal of directors may only be effected for cause and only upon the affirmative vote of at least eighty percent (80%) of the outstanding shares entitled to vote for directors, as well as a requirement that any vacancy on the board of directors may be filled only by the remaining directors;
9 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.