# EDGAR Filing Document

**Accession Number:** 0001121404
**File Stem:** 0001193125-23-077834
**Filing Date:** 2023-3
**Character Count:** 79845
**Document Hash:** 551025b7188bec3bdca62448225f26c8
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-077834.hdr.sgml**: 20230323

**ACCESSION NUMBER**: 0001193125-23-077834

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 9

**CONFORMED PERIOD OF REPORT**: 20230323

**FILED AS OF DATE**: 20230323

**DATE AS OF CHANGE**: 20230323

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Sanofi
- **CENTRAL INDEX KEY:** 0001121404
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 133529324
- **STATE OF INCORPORATION:** I0
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-31368
- **FILM NUMBER:** 23756116

**BUSINESS ADDRESS:**
- **STREET 1:** 46 AVENUE DE LA GRANDE ARMEE
- **CITY:** PARIS
- **STATE:** I0
- **ZIP:** 75017
- **BUSINESS PHONE:** 33153774400

**MAIL ADDRESS:**
- **STREET 1:** 46 AVENUE DE LA GRANDE ARMEE
- **CITY:** PARIS
- **STATE:** I0
- **ZIP:** 75017

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** SANOFI-AVENTIS
- **DATE OF NAME CHANGE:** 20040826

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** SANOFI SYNTHELABO SA
- **DATE OF NAME CHANGE:** 20010104

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**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549** 

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**FORM 6-K** 

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**REPORT OF FOREIGN PRIVATE ISSUER** 

**PURSUANT TO RULE 13a-16 OR 15d-16** 

**UNDER THE SECURITIES EXCHANGE ACT OF 1934** 

**For the month of March 2023** 

**Commission File Number: 001-31368** 

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## SANOFI
**(Translation of registrant's name into English)** 

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**46, avenue de la Grande Armée, 75017 Paris, FRANCE** 

**(Address of principal executive offices)** 

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Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

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In March 2023, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2, 99.3 and 99.4 which are incorporated herein by reference.

**Exhibit Index** 

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| |
|:---|
| Exhibit No. |
| Exhibit 99.1 [Press Release dated March 16, 2023: Sanofi cuts U.S. list price of Lantus<sup>®</sup>, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance](d434337dex991.htm) |
| Exhibit 99.2 [Press Release dated March 18, 2023: Dupixent<sup>®</sup> (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis](d434337dex992.htm) |
| Exhibit 99.3 [Press Release dated March 21, 2023: Dupixent<sup>®</sup> (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis](d434337dex993.htm) |
| Exhibit 99.4 [Press Release dated March 23, 2023: Dupixent<sup>®</sup> demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial](d434337dex994.htm) |

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

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| | | |
|:---|:---|:---|
| Dated: March 23, 2023 |  | SANOFI |
|  | By | /s/ Alexandra Roger |
|  |  | Name: Alexandra Roger |
|  |  | Title: Head of Securities Law and Capital Markets |

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## Exhibit 99.1

**Exhibit 99.1** 

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| | |
|:---|:---|
| **Press Release** | ![LOGO](g434337g0323203045943.jpg) |

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*Sanofi cuts U.S. list price of Lantus<sup>®</sup>, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance*

**Paris, March 16, 2023**. Sanofi announces that it will cut the list price of Lantus (insulin glargine injection) 100 Units/mL, its most widely prescribed insulin in the U.S., by 78 percent. The company also will establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance, underscoring its longstanding commitment to offer affordable access to medicines.

These moves, which go into effect January 1, 2024, will come in addition to decisions taken in June 2022 to lower diabetes medicines costs: the launch of an unbranded Lantus biologic at -60% versus Lantus list price, and a cap on out-of-pocket costs on insulin to $35 for all people without insurance. With all those decisions, now Sanofi's suite of savings programs ensures that no patient will pay more than $35 for a monthly supply of Lantus. Finally, Sanofi will also cut the list price of its short-acting Apidra (insulin glulisine injection) 100 Units/mL by 70%.

***Olivier Bogillot***

Head, U.S. General Medicines, Sanofi

*"Sanofi believes that no one should struggle to pay for their insulin and we are proud of our continued actions to improve access and affordability for millions of patients for many years. We launched our unbranded biologic for Lantus at 60 percent less than the Lantus list price in June 2022 but, despite this pioneering low-price approach, the health system was unable to take advantage of it due to its inherent structural challenges. We are pleased to see others join our efforts to help patients as we now accelerate the transformation of the U.S. insulin market. Our decision to cut the list price of our lead insulin needs to be coupled with broader change to the overall system to actually drive savings for patients at the pharmacy counter."*

*Sanofi Savings Programs* 

Sanofi will continue to provide different programs to ensure access and affordability to patients depending on their coverage situations and will continue to monitor policy and market changes. Our suite of innovative programs includes:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● **100% of commercially insured** people are eligible for Sanofi's copay assistance programs, regardless of
income or insurance plan design, which, in 2022 limited out-of-pocket expenses for a majority of participating patients to $15 or less for their diabetes medicines for a 30-day supply.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● **100% of uninsured** people are eligible for the <u>Insulins Valyou Savings Program</u> – regardless of income level – enabling them to buy one or multiple Sanofi insulins at $35 for a 30-day supply. The Soliqua (insulin glargine and lixisenatide) injection 100 Units/mL and 33 mcg/mL
cash offer also allows uninsured people to pay as little as $99 per box of pens, for up to two boxes of pens for a 30-day supply.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● We also provide free medications to qualified low- and middle-income patients
the <u>Sanofi Patient Connection program</u>. Some people facing an unexpected financial hardship may be eligible for a one-time, immediate month's supply of their Sanofi
medicine as they wait for their application to process.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Beginning in 2023, Sanofi insulins and Soliqua are included under the Inflation Reduction Act, where covered on Medicare
formulary, which provides insulin savings, capping monthly cost at $35 for Seniors who have Medicare Part D. This ensures a predictable, stable co-pay, regardless of phase including the donut hole.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Prior to the Inflation Reduction Act, Sanofi voluntarily participated in part of the Centers for Medicare and Medicaid
Services' (CMS) Senior Savings Model which allowed patients enrolled in participating Part D plans to pay a $35 or less co-pay for each 30-day prescription of a
Sanofi insulin throughout the year.

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Every patient has unique circumstances, and Sanofi has live support specialists who can be reached at (855) 984-6302 to answer individual patient's questions and navigate their unique situation to find the best resources and programs to help lower their out-of-pocket costs.

Learn more about Sanofi's transparent approach to pricing in our <u>2023 Pricing Principles Report</u>.

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*About Sanofi* 

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

*Media Relations* 

**Evan Berland** \| +1 215 432 0234 \| <u>evan.berland@sanofi.com</u>

**Sandrine Guendoul** \| + 33 6 25 09 14 25 \| <u>sandrine.guendoul@sanofi.com</u>

**Victor Rouault** \| + 33 6 70 93 71 40 \| <u>victor.rouault@sanofi.com</u>

*Investor Relations* 

**Eva Schaefer-Jansen** \| + 33 7 86 80 56 39 \| <u>eva.schaefer-jansen@sanofi.com</u>

**Arnaud Delépine** \| + 33 6 73 69 36 93 \| <u>arnaud.delepine@sanofi.com</u>

**Corentine Driancourt** \| + 33 6 40 56 92 21 \| <u>corentine.driancourt@sanofi.com</u>

**Felix Lauscher** \| + 1 908 612 7239 \| <u>felix.lauscher@sanofi.com</u>

**Tarik Elgoutni\|** + 1 617 710 3587 \| <u>tarik.elgoutni@sanofi.com</u>

**Nathalie Pham** \| + 33 7 85 93 30 17 \| <u>nathalie.pham@sanofi.com</u>

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**Sanofi Forward-Looking Statements** 

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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## Exhibit 99.2

**Exhibit 99.2** 

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| | |
|:---|:---|
| **Press Release** | ![LOGO](g434337g0323203221162.jpg) |

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*Dupixent<sup>®</sup> (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis*

\* More than twice as many patients on Dupixent achieved clear or almost clear skin compared to placebo at 16 weeks

\* Nearly four times as many patients on Dupixent saw a clinically meaningful reduction of itch, with improvements seen as early as one week

**Paris and Tarrytown, N.Y. March 18, 2023**. Positive results from the clinical trial assessing Dupixent<sup>®</sup> (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented today. The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting.

***Eric L. Simpson, M.D.***

Frances J. Storrs Professor of Medical Dermatology at the Oregon Health and Science University and principal investigator of this trial

*"Atopic hand and foot dermatitis can extensively disrupt the lives of patients, given the intense itch and painful skin lesions it causes on essential body areas. In this trial, Dupixent significantly improved disease signs, symptoms and quality of life measures for this particularly difficult-to-treat subset of atopic dermatitis patients, with itch improvement seen as early as one week after the first dose. While the efficacy and safety profile of Dupixent is well-established for atopic dermatitis more broadly, these positive results are the first demonstrating the impact on specific and heavily used areas of the body."*

In the trial, patients received Dupixent (n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n=66). At 16 weeks, patients treated with Dupixent experienced the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo (p ≤ 0.01), the primary endpoint.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● 52% saw a clinically meaningful reduction in itch on hands and feet compared to 14% with placebo (p<0.0001), the key
secondary endpoint.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● 69% average reduction in signs of hand and foot lesions from baseline compared to 31% with placebo (p<0.0001).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● 75% average improvement in hand eczema disease severity from baseline compared to 40% with placebo (p<0.0001).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● There were significant improvements in measures of hand and foot skin pain, sleep and hand eczema-related quality of life.

The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. Overall rates of adverse events (AEs) were 66% for Dupixent and 74% for placebo. AEs more commonly observed with Dupixent (≥5%) compared to placebo included nasopharyngitis (16% Dupixent, 11% placebo), upper respiratory tract infection (9% Dupixent, 5% placebo), conjunctivitis (6% Dupixent, 2% placebo), herpes viral infections (6% Dupixent, 3% placebo) and increased blood creatine phosphokinase (6% Dupixent, 0% placebo). Additionally, 3% of patients taking Dupixent used at least one rescue medication compared to 21% of patients on placebo.

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There are 23 Dupixent scientific abstracts being presented across three dermatological diseases with underlying type 2 inflammation at the AAD 2023 Annual Meeting. These include oral presentations on long-term Dupixent use in children as young as 6 months with atopic dermatitis; the impact of Dupixent treatment on health-related quality of life, skin pain and sleep in prurigo nodularis; and the investigational use of Dupixent on signs, symptoms and health-related quality of life in chronic spontaneous urticaria.

The potential use of Dupixent in chronic spontaneous urticaria is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

**About the Dupixent Trial** 

The Phase 3 double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in 133 adolescents and adults with moderate-to-severe atopic hand and foot dermatitis who had an inadequate response or intolerance to topical corticosteroids. Patients with hand and foot disease predominantly driven by allergic or irritant contact dermatitis were excluded from the trial.

The primary endpoint evaluated the proportion of patients with clear or almost clear skin of hand and feet eczema at 16 weeks (measured by a score of 0 or 1 on the Investigator Global Assessment Scale). The key secondary endpoint measured the proportion of patients with improvement in itch on hands and feet from baseline (measured by a ≥4-point reduction in Peak-Pruritis Numeric Rating Scale [PP-NRS] on a 0-10 scale) at 16 weeks. Lesion sign reduction was assessed by change from baseline in Modified Total Lesion Sign Score (mTLSS; measured by a 0-36 scale), and disease severity was assessed by the change from baseline in Hand Eczema Severity Index (HECSI) score (measured by a 0-360 scale). Symptoms were assessed every one or two weeks during the trial.

Additional secondary endpoints included:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Skin pain reduction as assessed by the change from baseline in weekly average of daily hand and foot peak pain NRS
(measured by a 0-10 scale).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Sleep improvement as assessed by change from baseline in weekly average of daily Sleep NRS (measured by a 0-10 scale).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Health-related quality of life, assessed by change from baseline in the Quality of Life in Hand Eczema Questionnaire
(QoLHEQ) (measured by a 0-117 scale).

**About Dupixent** 

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis.

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in the U.S., European Union and Japan. More than 600,000 patients are being treated with Dupixent globally.

**Dupilumab Development Program** 

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

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In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

**About Regeneron** 

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary *VelociSuite*<sup>®</sup> technologies, such as *VelocImmune*<sup>®</sup>, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For more information, please visit <u>www.Regeneron.com</u> or follow @Regeneron on Twitter.

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*About Sanofi* 

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

*Media Relations* 

**Sally Bain** \| + 1 617 834 6026 \| <u>sally.bain@sanofi.com</u> 

*Investor Relations* 

**Eva Schaefer-Jansen** \| + 33 7 86 80 56 39 \| <u>eva.schaefer-jansen@sanofi.com</u>

**Arnaud Delépine** \| + 33 6 73 69 36 93 \| <u>arnaud.delepine@sanofi.com</u>

**Corentine Driancourt** \| + 33 6 40 56 92 21 \| <u>corentine.driancourt@sanofi.com</u>

**Felix Lauscher** \| + 1 908 612 7239 \| <u>felix.lauscher@sanofi.com</u>

**Tarik Elgoutni\|** + 1 617 710 3587 \| <u>tarik.elgoutni@sanofi.com</u>

**Nathalie Pham** \| + 33 7 85 93 30 17 \| <u>nathalie.pham@sanofi.com</u>

*Regeneron Media Relations* 

**Hannah Kwagh** \| +1 914-847-6314 \| <u>hannah.kwagh@regeneron.com</u>

*Regeneron Investor Relations* 

**Vesna Tosic** \| + 914 847 5443 \| <u>vesna.tosic@regeneron.com</u>

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**Sanofi Disclaimers or Forward-Looking Statements** 

*This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or* 

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 *implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.* 

**Regeneron Forward-Looking Statements and Use of Digital Media** 

*This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation Dupixent; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as Dupixent for the treatment atopic hand and foot dermatitis as discussed in this press release as well as for the treatment of pediatric eosinophilic esophagitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA<sup>®</sup> (aflibercept) Injection, Praluent<sup>®</sup> (alirocumab), and REGEN-COV<sup>®</sup> (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.* 

*Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).* 

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## Exhibit 99.3

**Exhibit 99.3**![LOGO](g434337g0323203426053.jpg)

**Press Release** 

*Dupixent<sup>®</sup> (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Approximately seven times as many patients aged 6 months to 5 years with severe atopic dermatitis treated with Dupixent
experienced clear or almost clear skin and reduced overall disease severity compared to placebo

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Patients treated with Dupixent achieved rapid itch reduction as early as three weeks after start of therapy, with
significant improvements at 16 weeks sustained through one year

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Dupixent is now a treatment option for the approximately 80,000 infants and young children living with uncontrolled severe
atopic dermatitis in Europe

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Milestone marks third Dupixent European Commission approval in the past four months

**Paris and Tarrytown, N.Y. March 21, 2023**. The European Commission (EC) has approved Dupixent<sup>®</sup> (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. With this approval, Dupixent is the first and only targeted medicine indicated to treat these young children in Europe and the <u>U.S.</u>

***Korey Capozza, MPH***

Founder and Executive Director of Global Parents for Eczema Research (GPER)

*"Watching an infant or young child grapple with the debilitating and wide-reaching impacts of severe atopic dermatitis is heartbreaking. I've personally witnessed how this chronic skin disease can disrupt the lives of entire families when left uncontrolled. Intervening with effective treatments during infancy and early childhood can help manage the challenging impact this disease has on children and their families during such formative years."* 

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, crusting and oozing, which can increase the risk of skin infection. Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Treatment options in this age group are primarily topical corticosteroids (TCS), which can be associated with safety risks and may impair growth when used long-term.

***Naimish Patel, M.D.***

Head of Global Development, Immunology and Inflammation at Sanofi 

*"A vast majority of people with atopic dermatitis begin to develop symptoms during their earliest, most vulnerable years, and these symptoms can often continue through the rest of their lives. With this latest approval, Dupixent is the first-ever biologic medicine for people living with atopic dermatitis from infancy to adulthood. Given its well-established safety and efficacy profile, Dupixent has the potential to transform the landscape for people of all ages living with atopic dermatitis. We remain committed to exploring Dupixent for the treatment of other chronic inflammatory skin diseases."* 

***George D. Yancopoulos, M.D., Ph.D.***

President and Chief Scientific Officer at Regeneron 

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*"No infant or child should have to spend their earliest days suffering with the intense and unrelenting itch and skin pain of atopic dermatitis. Too often the parents and caregivers of children with severe atopic dermatitis are left desperate for new treatments to manage this chronic disease. In the pivotal trial, Dupixent reduced itch and skin pain, and improved health-related quality of life and sleep quality. Dupixent is currently being used to treat more than 600,000 patients around the word across approved indications. This latest EU approval brings the proven efficacy, and importantly, the long-term safety profile of Dupixent to this particularly vulnerable population."* 

The approval is based on data from a <u>Phase 3 trial</u> evaluating Dupixent every four weeks (200 mg or 300 mg based on body weight) plus low-potency TCS or TCS alone (placebo) in 162 children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. At 16 weeks, Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo in the overall enrolled population. In a subset of those with severe atopic dermatitis, patients randomized to Dupixent (n=63) experienced the following compared to placebo (n=62) at 16 weeks:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● 46% of patients achieved 75% or greater improvement in overall disease severity compared to 7% treated with placebo, a co-primary endpoint.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● 14% of patients achieved clear or almost clear skin compared to 2% treated with placebo, a co-primary endpoint.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● 55% average reduction in overall disease severity from baseline compared to 10% with placebo.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● 42% average reduction in itch from baseline compared to a 1% increase with placebo.

Dupixent also improved sleep quality, skin pain and health-related quality of life compared to placebo in both the overall and severe populations. Long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks.

The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. The safety results of the 6 months to 5 years old trial were generally consistent with the known safety profile of Dupixent in its approved indications; in the trial, adverse events more commonly observed (≥5%) with Dupixent compared to placebo included eosinophilia and conjunctivitis. The long-term safety profile through 52 weeks was similar to the safety profile observed at 16 weeks, and consistent with what was observed in older patients with atopic dermatitis.

**About the Pivotal Dupixent Atopic Dermatitis Trial** 

The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent added to standard-of-care low-potency TCS compared to low-potency TCS alone (placebo) in 162 children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.

The co-primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75) at week 16. Additional endpoints measured itch (assessed by a caregiver-reported worst scratch/itch numerical rating scale from 0-10), sleep quality (assessed by a caregiver-reported numerical rating scale from 0-10), skin pain (assessed by a caregiver-reported numerical rating scale from 0-10) and health-related quality of life (assessed by the Children's Dermatology Life Quality Index in patients aged 4 to 5 years and the Infants' Dermatitis Quality of Life Index in patients aged 6 months to 3 years, both scales from 0-30).

**About Dupixent** 

Dupixent is an injection administered under the skin (subcutaneous injection) at different injection sites. In patients aged 6 months to 5 years, Dupixent is administered with a pre-filled syringe every four weeks based on weight (200 mg for children ≥5 to <15 kg and 300 mg for children ≥15 to <30 kg). Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home. Dupixent does not require initial lab testing or ongoing lab monitoring.

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Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis.

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 600,000 patients are being treated with Dupixent globally.

**Dupilumab Development Program** 

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

**About Regeneron** 

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite<sup>®</sup> technologies, such as VelocImmune<sup>®</sup>, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For more information, please visit <u>www.Regeneron.com</u> or follow @Regeneron on Twitter.

------

*About Sanofi* 

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

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Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

*Media Relations* 

**Sally Bain** \| + 1 617 834 6026 \| <u>sally.bain@sanofi.com</u>

*Investor Relations* 

**Eva Schaefer-Jansen** \| + 33 7 86 80 56 39 \| <u>eva.schaefer-jansen@sanofi.com</u>

**Arnaud Delépine** \| + 33 6 73 69 36 93 \| <u>arnaud.delepine@sanofi.com</u>

**Corentine Driancourt** \| + 33 6 40 56 92 21 \| <u>corentine.driancourt@sanofi.com</u>

**Felix Lauscher** \| + 1 908 612 7239 \| <u>felix.lauscher@sanofi.com</u>

**Tarik Elgoutni\|** + 1 617 710 3587 \| <u>tarik.elgoutni@sanofi.com</u>

**Nathalie Pham** \| + 33 7 85 93 30 17 \| <u>nathalie.pham@sanofi.com</u>

*Regeneron Media Relations* 

**Hannah Kwagh** \| +1 914-847-6314 \| <u>hannah.kwagh@regeneron.com</u>

*Regeneron Investor Relations* 

**Vesna Tosic** \| + 914 847 5443 \| <u>vesna.tosic@regeneron.com</u>

------

**Sanofi Forward-Looking Statements** 

*This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.* 

**Regeneron Forward-Looking Statements and Use of Digital Media** 

*This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation Dupixent<sup>®</sup> (dupilumab) for the treatment of severe atopic dermatitis in children 6 months to 5 years old; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as Dupixent for the treatment of pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in* 

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 *other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA<sup>®</sup> (aflibercept) Injection, Praluent<sup>®</sup> (alirocumab), and REGEN-COV<sup>®</sup> (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.* 

*Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (<u>http://newsroom.regeneron.com</u>) and its Twitter feed (<u>http://twitter.com/regeneron</u>).* 

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## Exhibit 99.4

**Exhibit 99.4** 

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|:---|:---|
| **Press Release** | ![LOGO](g434337g0323203045943.jpg) |

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*Dupixent<sup>®</sup> demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● First and only biologic to demonstrate clinically meaningful and statistically significant (30%) reduction in
exacerbations compared to maximal standard-of-care inhaled therapy

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● First and only biologic to show rapid and significant improvement (160 mL in FEV<sub>1</sub>) in lung function compared to maximal standard of care inhaled therapy (77 mL in FEV<sub>1</sub>)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● First and only biologic to demonstrate significant improvements in quality of life and respiratory symptoms

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● COPD is the third leading cause of death worldwide with no new treatment approaches approved in more than a decade;
trial enrolled patients with moderate to severe disease and evidence of type 2 inflammation (i.e., blood eosinophils ≥ 300 cells/ m L)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● COPD is the seventh disease in which Dupixent has shown positive pivotal results, confirming the key role of IL-4 and IL-13 in these type 2 inflammatory diseases

**Paris and Tarrytown, N.Y. March 23, 2023**. The primary and all key secondary endpoints were met in a Phase 3 trial evaluating the investigational use of Dupixent<sup>®</sup> (dupilumab) added to maximal standard-of-care inhaled therapy (triple therapy) in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation. Dupixent is the first and only biologic to demonstrate a clinically meaningful and highly significant (30%) reduction in moderate or severe acute exacerbations of COPD (rapid and acute worsening of respiratory symptoms), while also demonstrating significant improvements in lung function, quality of life and COPD respiratory symptoms.

***Dietmar Berger, M.D., Ph.D.***

Head of Global R&D ad interim and Chief Medical Officer at Sanofi

*"Change cannot come quick enough for people living with uncontrolled COPD but, unfortunately, many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options. We took a bold approach with our direct to Phase 3 program, shaving years off standard clinical development timelines. We are excited to share these unprecedented and potentially paradigm-shifting clinical results, which may give new hope to patients, caregivers and physicians."*

COPD is a life-threatening respiratory disease that damages the lungs and causes progressive lung function decline. Symptoms include persistent cough and breathlessness that may not only impair the ability to perform routine daily activities, but can also lead to anxiety, depression and sleep disturbances. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization or even death. Smoking is a key risk factor for COPD, but even individuals who quit smoking can still develop the disease. In the U.S. alone, approximately 300,000 people live with uncontrolled COPD with type 2 inflammation.

***George D. Yancopoulos, M.D., Ph.D.***

President and Chief Scientific Officer at Regeneron 

*"COPD is an urgent global health concern and a notoriously difficult-to-treat disease due to its heterogeneity, with no new treatments approved in more than a decade. In this landmark Phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic. These results also validated the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific community's understanding of the underlying biology of this disease. We look forward to discussing these exciting results with regulatory authorities."*

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In the BOREAS Phase 3 trial (the first of two Phase 3 trials), 939 adults who were current or former smokers aged 40 to 80 years were randomized to receive Dupixent (n=468) or maximal standard-of-care inhaled therapy (n=471). Patients who added Dupixent to triple therapy experienced the following, compared to maximal standard-of-care inhaled therapy:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0005), the primary endpoint.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Improved lung function from baseline by 160 mL at 12 weeks compared to 77 mL for maximal standard-of-care inhaled therapy (p<0.0001), with the benefit versus maximal standard-of-care sustained through week 52 (p=0.0003), both of which were key secondary endpoints.

Dupixent met all endpoints tested in the hierarchy, including improvement in patient-reported health-related quality of life as measured by St. George's Respiratory Questionaire (SGRQ) and reduction in the severity of respiratory symptoms of COPD as measured by Evaluation Respiratory Symptoms: COPD (E-RS: COPD).

The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. For the 52-week treatment period, overall rates of adverse events (AE) were 77% for Dupixent and 76% for maximal standard-of-care inhaled therapy. AEs more commonly observed with Dupixent compared to maximal standard-of-care inhaled therapy included headache (8.1% Dupixent, 6.8% maximal standard-of-care inhaled therapy), diarrhea (5.3% Dupixent, 3.6% maximal standard-of-care inhaled therapy) and back pain (5.1% Dupixent, 3.4% maximal standard-of-care inhaled therapy). Adverse events more commonly observed with maximal standard-of-care inhaled therapy compared to Dupixent included upper respiratory tract infection (9.8% maximal standard-of-care inhaled therapy, 7.9% Dupixent), hypertension (6.0% maximal standard-of-care inhaled therapy, 3.6% Dupixent) and COVID-19 (5.7% maximal standard-of-care inhaled therapy, 4.1% Dupixent). AEs leading to deaths were balanced between the two arms (1.7% maximal standard-of-care inhaled therapy, 1.5% Dupixent).

Detailed efficacy and safety results from this trial will be presented in a future scientific forum.

The broader Sanofi and Regeneron COPD clinical research program includes Phase 3 trials with itepekimab, a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33). Itepekimab received Fast Track Designation from the U.S. Food and Drug Administration in January 2023 for the treatment of COPD in patients who do not currently smoke. Data from this pivotal program is expected in 2025.

The safety and efficacy of Dupixent and itepekimab in COPD have not been fully evaluated by any regulatory authority.

**About the Dupixent COPD Phase 3 Trial Program** 

BOREAS is one of two pivotal trials in the Dupixent COPD program. The randomized, Phase 3, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in 939 adults who were current or former smokers aged 40 to 80 years with moderate-to-severe COPD. All patients in the trial had evidence of type 2 inflammation, as measured by blood eosinophils ≥300 cells/µL. During the 52-week treatment period, patients received Dupixent or placebo every two weeks added to triple therapy of inhaled corticosteroids (ICS), long-acting beta agonists, and long-acting muscarinic antagonists. Double maintenance therapy was allowed if ICS was contraindicated.

The primary endpoint evaluated the annualized rate of acute moderate or severe COPD exacerbations. Moderate exacerbations were defined as those requiring systemic steroids and/or antibiotics. Severe exacerbations were defined as those: requiring hospitalization; more than a day of observation in an emergency department or urgent care facility; or resulting in death. Key secondary endpoints included change from baseline in lung function (assessed by pre-bronchodilator FEV<sub>1</sub>) at 12 and 52 weeks; change from baseline at week 52 in SGRQ total score compared to maximal standard-of-care inhaled therapy and proportion of patients with SGRQ improvement ≥4 points at week 52.

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The second, replicate Phase 3 trial of Dupixent in COPD (NOTUS) is ongoing with data expected in 2024.

**About Sanofi and Regeneron's COPD Clinical Research Program** 

Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through the investigation of two potentially first-in-class biologics, Dupixent and itepekimab.

Dupixent inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and the program focuses on a specific population of people with evidence of type 2 inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of broad inflammation in COPD. Across both programs, four Phase 3 trials are ongoing and designed to inform next-generation treatments for people with COPD who might not have other options.

**About Dupixent** 

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and eosinophilic esophagitis (EoE).

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 600,000 patients are being treated with Dupixent globally.

**Dupilumab Development Program** 

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, COPD with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

------

*About Regeneron* 

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.Regeneron is accelerating and improving the traditional drug development process through our proprietary *VelociSuite*<sup>®</sup> technologies, such as *VelocImmune*<sup>®</sup>, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit <u>www.Regeneron.com</u> or follow @Regeneron on Twitter.

*About Sanofi* 

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

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| ![LOGO](g434337g18l69.jpg)  | 3/5 |

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*Media Relations* 

**Sandrine Guendoul** \| + 33 6 25 09 14 25 \| <u>sandrine.guendoul@sanofi.com</u>

**Sally Bain** \| + 1 617 834 6026 \| <u>sally.bain@sanofi.com</u>

**Chrystel Baude** \| + 33 6 70 98 70 59 \| <u>chrystel.baude@sanofi.com</u>

**Evan Berland** \| +1 215 432 0234 \| <u>evan.berland@sanofi.com</u>

**Kate Conway** \| + 1 508 364 4931 \| <u>kate.conway@sanofi.com</u>

**Nicolas Obrist** \| + 33 6 77 21 27 55 \| <u>nicolas.obrist@sanofi.com</u>

**Victor Rouault** \| + 33 6 70 93 71 40 \| <u>victor.rouault@sanofi.com</u>

*Investor Relations* 

**Eva Schaefer-Jansen** \| + 33 7 86 80 56 39 \| <u>eva.schaefer-jansen@sanofi.com</u>

**Arnaud Delépine** \| + 33 6 73 69 36 93 \| <u>arnaud.delepine@sanofi.com</u>

**Corentine Driancourt** \| + 33 6 40 56 92 21 \| <u>corentine.driancourt@sanofi.com</u>

**Felix Lauscher** \| + 1 908 612 7239 \| <u>felix.lauscher@sanofi.com</u>

**Tarik Elgoutni\|** + 1 617 710 3587 \| <u>tarik.elgoutni@sanofi.com</u> 

**Nathalie Pham** \| + 33 7 85 93 30 17 \| <u>nathalie.pham@sanofi.com</u>

*Regeneron Media Relations* 

**Sharon Chen** \| +1 914-847-1546 \| <u>sharon.chen@regeneron.com</u>

*Regeneron Investor Relations* 

**Vesna Tosic** \| + 914 847 5443 \| <u>vesna.tosic@regeneron.com</u>

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**Sanofi Disclaimers or Forward-Looking Statements** 

*This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.* 

**Regeneron Forward-Looking Statements and Use of Digital Media** 

*This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation Dupixent<sup>®</sup> (dupilumab) in patients with uncontrolled chronic obstructive pulmonary disease ("COPD") and evidence of type 2 inflammation and itepekimab (a fully human monoclonal antibody that binds to and inhibits interleukin-33) in patients with COPD as discussed in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as Dupixent for the treatment of COPD as discussed in this press release as well as for the treatment of pediatric eosinophilic esophagitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products (such as Dupixent for the treatment of COPD) and Regeneron's Product Candidates (such as itepekimab); the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates (such as itepekimab) in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product* 

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| ![LOGO](g434337g18l69.jpg)  | 4/5 |

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 *candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA<sup>®</sup> (aflibercept) Injection, Praluent<sup>®</sup> (alirocumab), and REGEN-COV<sup>®</sup> (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.* 

*Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).* 

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| ![LOGO](g434337g18l69.jpg)  | 5/5 |

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