Regeneron Pharmaceuticals (REGN) Economic Moat Analysis56

Evidence

In April 2026, the FDA approved the extension of dosing intervals for EYLEA HD up to every 20 weeks for wAMD and DME.

2026 proxy, page 59: April 2026 EYLEA HD extended-dosing approval · Filed 24/04/2026

Regulatory Actions EYLEA HD: Obtained FDA approval for the treatment of macular edema following retinal vein occlusion (“RVO”) and a positive opinion by the European Medicines Agency for the same indication Obtained FDA approval for every 4-week dosing regimen for approved indications Obtained European Commission (“EC”) approval for extended dosing intervals in wet age‑related macular degeneration (“wAMD”) and diabetic macular edema (“DME”) Received Complete Response Letters (“CRLs”) from FDA for supplemental Biologics License Application (“sBLA”) for addition of extended dosing intervals and for regulatory application for pre-filled syringe* Dupixent: Obtained FDA and EC approvals for the treatment of chronic spontaneous urticaria (“CSU”) in adults and adolescents Obtained FDA approval for the treatment of bullous pemphigoid Obtained approvals by Japan’s Ministry of Health, Labour and Welfare (“MHLW”) for the treatment of asthma in pediatrics and the treatment of chronic obstructive pulmonary disease (“COPD”) Oncology & Hematology: Obtained FDA and EC approvals for Libtayo in adjuvant cutaneous squamous cell carcinoma (“CSCC”) Obtained FDA and EC approvals for Lynozyfic® (linvoseltamab) in relapsed/refractory (“R/R”) multiple myeloma Received CRL from FDA for OrdsponoTM (odronextamab) Biologics License Application (“BLA”) for R/R follicular lymphoma* Clinical and Significant Pipeline Developments EYLEA HD: Presented positive three‑year data from extension study of Phase 3 wAMD trial Immunology & Inflammation: Reported that Phase 3 trial of Dupixent in allergic fungal rhinosinusitis (“AFRS”) met its primary and key secondary endpoints Reported that Phase 3 trial of cemdisiran (siRNA therapeutic targeting C5) in generalized myasthenia gravis met its primary and key secondary endpoints Reported that one of two Phase 3 trials evaluating itepekimab (IL-33 antibody) in adults who were former smokers with inadequately controlled COPD did not meet its primary endpoint Reported that Phase 3 trials evaluating REGN5713-5715 (multi- antibody therapy to Bet v 1) and REGN1908-1909 (multi- antibody therapy to Fel d 1) for birch allergy and cat allergy, respectively, met their primary and key secondary endpoints Neurology & Rare Diseases: Reported that Phase 3 trial of garetosmab (antibody to Activin A) in fibrodysplasia ossificans progressiva (“FOP”) met its primary endpoint; submitted a BLA to the FDA and a regulatory application in the EU for this indication Reported updated data from pivotal trial of DB-OTO (AAV-based gene therapy) for profound genetic hearing loss; submitted BLA to the FDA for this indication, for which the FDA granted a Commissioner’s National Priority Voucher Commercial and Operational Execution EYLEA HD: Increased full‑year 2025 U.S.

2026 proxy: regulatory actions and clinical developments · Filed 24/04/2026

net product sales 36% to $1.64 billion Dupixent: Increased full‑year 2025 global net product sales (recorded by our collaborator Sanofi) 26% to $17.81 billion versus 2024 Recognized as the “Best Biotechnology Product” of 2025 by the Galien Foundation Libtayo: Increased full‑year 2025 global net product sales 19% to $1.45 billion versus 2024 Other Operational Achievements: Expanded U.S.

2026 proxy: 2025 commercial execution and product net-sales growth · Filed 24/04/2026

We rely on a combination of intellectual property laws, including patent, trademark, copyright, trade secret, and domain name protection laws, as well as confidentiality and license agreements, to protect our intellectual property and proprietary rights.

Business: patents, trademarks and trade secrets · Filed 04/02/2026

•15 internally developed medicines approved or authorized over past ~15 years

2026 proxy: internally developed medicines approved or authorized · Filed 24/04/2026

•Dupixent: >1.4M patients actively treated globally; $17.8B in 2025 global net

2026 proxy: global active Dupixent patient population · Filed 24/04/2026

Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, have in the past reduced and could reduce in the future the duration of market exclusivity for our products.

Risk factors: historical and potential limitations of market exclusivity · Filed 04/02/2026

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; and, in the case of EYLEA HD and EYLEA, the existing and potential new branded and biosimilar competition (discussed further under "The commercial success of our products and product candidates is subject to significant competition - Marketed Products" below) and the willingness of retinal specialists and patients to start or continue treatment with such products or to switch from a competitive product to one of our products; •the safety and efficacy of our marketed products seen in a broader patient group (i.e., real-world use); •the effect of existing and new healthcare laws and regulations, pricing mandates, and agreements with government entities (including the U.S.

Risk factors: branded and biosimilar competition and treatment switching · Filed 30/07/2026

There are systemic JAK inhibitors and antibodies against IL-13 and IL-4Ra approved or in development for atopic dermatitis.

Competition: approved and developing alternatives for atopic dermatitis · Filed 04/02/2026

Private payor healthcare and insurance providers, health maintenance organizations, and PBMs are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and copayment/coinsurance.

Risk factors: payor formulary discounts and rebates · Filed 04/02/2026

manufacturing capabilities internally and in partnership with Fujifilm Diosynth Biotechnologies; made progress toward reducing reliance on third-party manufacturing fillers by advancing process validation of the Company’s first fill/ finish facility located in Rensselaer, New York Announced donation of Inmazeb® (atoltivimab, maftivimab, and odesivimab-ebgn), an Ebola treatment, to the World Health Organization for exclusive use by governments of low- and lower-middle income countries Financial Execution and Talent Management Financial Results: Grew full‑year 2025 revenues 1% to $14.34 billion versus 2024 Achieved GAAP and non‑GAAP diluted net income per share, or EPS, of $41.48 and $44.31,** respectively Capital Allocation: Invested $5.9 billion in research and development (“R&D”); deployed nearly $900 million in capital expenditures primarily to expand our U.S.-based research and manufacturing facilities Invested in significant business development opportunities, including the in-licensing of a late-stage GLP-1/GIP agonist Repurchased $3.5 billion of common stock Initiated first-ever quarterly cash dividend program Talent Management: Achieved industry-leading retention rate of nearly 93% in 2025 Received positive employee feedback, with 81% of employees indicating in a company‑wide survey that Regeneron is a great place to work For the 15th year in a row, placed in the top five in Science magazine’s annual “Top Employers Survey” of the global biotechnology and pharmaceutical industry *The CRLs for the EYLEA HD pre-filled syringe regulatory application and the Ordspono BLA cited unresolved inspection findings at a third-party manufacturer responsible for filling drug product.

2026 proxy: capital allocation, manufacturing progress and CRL inspection findings · Filed 24/04/2026

•We are substantially dependent on revenues derived from net product sales of EYLEA HD, EYLEA, and Dupixent.

Risk-factor summary: dependence on principal product revenues · Filed 30/07/2026

2026 Proxy Statement and Notice of Annual Shareholder Meeting 111 Introduction Board of Directors Corporate Governance The Company Compensation-Related Matters Other Matters Reconciliation of GAAP to Non-GAAP Financial Information (Unaudited) (In millions, except per share data) Year Ended December 31, 2025 2024 GAAP research and development (“R&D”) $5,850.2 $5,132.0 Stock-based compensation expense 545.4 543.8 Acquisition and integration costs — 24.9 Priority review voucher 155.0 — Non-GAAP R&D $5,149.8 $4,563.3 GAAP selling, general, and administrative (“SG&A”) $2,700.0 $2,954.4 Stock-based compensation expense 362.9 355.0 Acquisition and integration costs 0.8 42.2 Litigation settlements 25.0 13.0 Non-GAAP SG&A $2,311.3 $2,544.2 GAAP cost of goods sold (“COGS”) $1,140.8 $1,087.3 Stock-based compensation expense 85.4 84.0 Acquisition and integration costs — 2.0 Intangible asset amortization expense 131.7 103.5 Non-GAAP COGS $923.7 $897.8 GAAP other operating (income) expense, net $(10.0) $53.4 Change in fair value of contingent consideration — 53.4 Non-GAAP other operating (income) expense, net $(10.0) $— GAAP other income (expense), net $1,652.8 $789.2 Losses (gains) on marketable and other securities, net (946.1) (118.3) Non-GAAP other income (expense), net $706.7 $670.9 GAAP net income $4,504.9 $4,412.6 Total of GAAP to non-GAAP reconciling items above 360.1 1,103.5 Income tax effect of GAAP to non-GAAP reconciling items (54.4) (196.9) Income tax expense: Shortfall from stock-based compensation 32.6 — Income tax expense: Charge related to enactment of “One Big Beautiful Bill Act” 44.5 — Non-GAAP net income $4,887.7 $5,319.2 Non-GAAP net income per share - basic $46.73 $49.30 Non-GAAP net income per share - diluted $44.31 $45.62 Shares used in calculating: Non-GAAP net income per share - basic 104.6 107.9 Non-GAAP net income per share - diluted 110.3 116.6

2026 proxy, Appendix A, page 111: 2025 and 2024 GAAP and non-GAAP reconciliation · Filed 24/04/2026

Business Highlights We delivered top- and bottom-line growth: Grew full-year 2025 revenues 1% to $14.34 billion versus 2024; achieved full-year 2025 GAAP and non-GAAP diluted net income per share, or EPS, of $41.48 and $44.31, respectively.2 We returned capital to our shareholders: Repurchased $3.5 billion of common stock and initiated quarterly cash dividend program.

2026 proxy: 2025 revenue, earnings and shareholder distributions · Filed 24/04/2026

In some of these countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.

Pricing regulation: prior governmental approval of proposed drug prices · Filed 05/02/2025

The amount of the rebate is adjusted upward if the average manufacturer price increases more than inflation (measured by reference to the Consumer Price Index - Urban).

Government pricing programs: inflation-linked Medicaid rebate adjustment · Filed 04/02/2026

Government Agreements will likely result, and any potential future agreements with government entities could also result, in reduced prices and reimbursement for certain of our current and future marketed products and may impact our results of operations.

Risk factors: expected pricing effects of government agreements · Filed 29/04/2026

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (In millions) Class A Stock Common Stock Additional Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity Shares Amount Shares Amount Shares Amount Balance, December 31, 2022 1.8 $ — 130.4 $ 0.1 $ 9,949.3 $ 23,306.7 $ (238.8) (22.6) $ (10,353.3) $ 22,664.0 Issuance of Common Stock for equity awards granted under long-term incentive plans — — 3.5 — 1,152.2 — — — — 1,152.2 Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — (0.8) — (708.4) — — — — (708.4) Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 66.6 — — 0.1 7.5 74.1 Repurchases of Common Stock — — — — — — — (3.0) (2,214.6) (2,214.6) Stock-based compensation charges — — — — 894.3 — — — — 894.3 Net income — — — — — 3,953.6 — — — 3,953.6 Other comprehensive income, net of tax — — — — — — 157.9 — — 157.9 Balance, December 31, 2023 1.8 — 133.1 0.1 11,354.0 27,260.3 (80.9) (25.5) (12,560.4) 25,973.1 Issuance of Common Stock for equity awards granted under long-term incentive plans — — 4.1 — 1,454.6 — — — — 1,454.6 Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — (1.2) — (1,021.3) — — — — (1,021.3) Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 71.7 — — 0.1 6.9 78.6 Repurchases of Common Stock — — — — — — — (2.8) (2,613.9) (2,613.9) Stock-based compensation charges — — — — 996.9 — — — — 996.9 Net income — — — — — 4,412.6 — — — 4,412.6 Other comprehensive income, net of tax — — — — — — 73.0 — — 73.0 Balance, December 31, 2024 1.8 — 136.0 0.1 12,855.9 31,672.9 (7.9) (28.2) (15,167.4) 29,353.6 F-6 Table of Contents CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (continued) Class A Stock Common Stock Additional Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity Shares Amount Shares Amount Shares Amount Issuance of Common Stock for equity awards granted under long-term incentive plans — — 2.6 — 637.4 — — — — 637.4 Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — (1.0) — (576.2) — — — — (576.2) Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 72.2 — — 0.1 10.8 83.0 Repurchases of Common Stock — — — — — — — (5.6) (3,456.2) (3,456.2) Dividends declared — — — — 4.1 (380.7) — — — (376.6) Stock-based compensation charges — — — — 1,001.6 — — — — 1,001.6 Net income — — — — — 4,504.9 — — — 4,504.9 Other comprehensive income, net of tax — — — — — — 85.4 — — 85.4 Balance, December 31, 2025 1.8 $ — 137.6 $ 0.1 $ 13,995.0 $ 35,797.1 $ 77.5 (33.7) $ (18,612.8) $ 31,256.9 The accompanying notes are an integral part of the financial statements.

Consolidated statements of stockholders' equity, F-6: earnings, equity issuance, compensation and repurchases · Filed 04/02/2026

Three Months Ended June 30, Six Months Ended June 30, (In millions) 2026 2025 2026 2025 Number of shares 1.7 1.9 2.7 3.4 Total cost of shares $ 1,164.5 $ 1,069.9 $ 1,967.7 $ 2,122.3 As of June 30, 2026, $2.534 billion remained available for share repurchases under the Company's share repurchase programs.

Note 9: actual first-half 2026 share repurchases · Filed 30/07/2026

As of June 30, 2026, the "development balance," which represented the Company's obligation to reimburse Sanofi for development expenses that were previously funded by Sanofi, was fully repaid and will no longer reduce Sanofi collaboration revenue beginning in the third quarter of 2026.

Sanofi collaboration: development balance fully repaid at June 30, 2026 · Filed 30/07/2026

–2020 CEO/CSO PSUs (which vested in December 2025 and must be held until December 2028) were earned solely based on the relevant TSR-based performance criteria.

Executive compensation: vested 2020 CEO/CSO performance awards and holding requirement · Filed 24/04/2026

For example, as of year-end 2025, both our CEO and CSO held shares with a value over 400x of their respective base salaries then in effect.

Executive compensation: actual year-end 2025 CEO and CSO shareholdings relative to salary · Filed 24/04/2026

The RSAs vest 50% on the second anniversary of the date of grant and 50% on the fourth anniversary of the date of grant, which is a more backloaded vesting schedule than is typical in the industry.

Executive compensation: restricted-stock award vesting schedule · Filed 24/04/2026

In accordance with our Corporate Governance Guidelines, the board conducts executive sessions of independent directors presided by the Lead Independent Director in connection with each regularly scheduled board meeting, as discussed further below.

Corporate governance: independent-director executive sessions · Filed 24/04/2026

As further discussed in the subsection “Board Governance—Declassification of the Board of Directors,” at our 2025 annual meeting, our board of directors proposed and shareholders approved an amendment to the Company’s Certificate of Incorporation to declassify the board.

Corporate governance: shareholder-approved 2025 board declassification amendment · Filed 24/04/2026

These provisions include: •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; •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; •a provision whereby any action required or permitted to be taken at any meeting of shareholders may be taken without a meeting, only if, prior to such action, all of our shareholders consent, the effect of which is to require that shareholder action may only be taken at a duly convened meeting; •a requirement that any shareholder seeking to bring business before an annual meeting of shareholders must provide timely notice of this intention in writing and meet various other requirements; and •under the New York Business Corporation Law, in addition to certain restrictions which may apply to "business combinations" involving our Company and an "interested shareholder," a plan of merger or consolidation of our Company must be approved by two-thirds of the votes of all outstanding shares entitled to vote thereon.

Risk factors: board declassification timetable and remaining takeover protections · Filed 30/07/2026

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.

Capital structure: unequal voting rights · Filed 30/07/2026

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.

Capital structure: Class A voting power at June 30, 2026 · Filed 30/07/2026

c. Proceedings Relating to Praluent (alirocumab) Injection On May 27, 2022, the Company filed a lawsuit against Amgen in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws.

Litigation: Amgen's alleged exclusionary bundling affecting Praluent · Filed 30/07/2026

A trial was held in May 2025. On May 15, 2025, the jury reached a verdict in Regeneron's favor on nine of the ten counts submitted to it and awarded Regeneron $135.6 million in compensatory damages and $271.2 million in punitive damages.

Litigation: May 2025 jury verdict in Praluent proceedings · Filed 30/07/2026

On June 20, 2025, Amgen filed a post-trial motion for judgment as a matter of law or, in the alternative, for a new trial.

Litigation: Amgen's post-trial challenge to the verdict · Filed 30/07/2026

Publication history

Sources

• filing-1 · Filed 04/02/2026
• filing-2 · Filed 30/07/2026
• filing-3 · Filed 24/04/2026
• filing-4 · Filed 05/02/2025
• filing-5 · Filed 05/02/2024
• filing-6 · Filed 29/04/2026