# EDGAR Filing Document

**Accession Number:** 0001121404
**File Stem:** 0001193125-23-048991
**Filing Date:** 2023-2
**Character Count:** 36154
**Document Hash:** d13ed1360e08e20c797f413340a2654d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-048991.hdr.sgml**: 20230224

**ACCESSION NUMBER**: 0001193125-23-048991

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 6

**CONFORMED PERIOD OF REPORT**: 20230224

**FILED AS OF DATE**: 20230224

**DATE AS OF CHANGE**: 20230224

**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:** 23668721

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

**Exhibit Index** 

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| |
|:---|
| **Exhibit No.** |
| Exhibit 99.1 [Press Release dated February 23, 2023: FDA approves once-weekly ALTUVIIIO<sup>™</sup>, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection](d456470dex991.htm) |
| Exhibit 99.2 [Press Release dated February 24, 2023: FDA approves once-weekly ALTUVIIIO<sup>™</sup>, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection. This positive event triggers impairment reversal, impacting 2022 IFRS net income; no change on business net income (non-IFRS) ](d456470dex992.htm) |
| Exhibit 99.3 [Press Release dated February 24, 2023: New Phase 3 data presented at WORLDSymposium<sup>™</sup> reinforce Nexviazyme<sup>®</sup> (avalglucosidase alfa) as potential new standard of care for all people living with late-onset Pompe disease](d456470dex993.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: February 24, 2023 | SANOFI | 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](g456470g0224111757509.jpg) |

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*FDA approves once-weekly ALTUVIIIO<sup>™</sup>, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection* 

**Paris and Stockholm – February 23, 2023 –** The U.S. Food and Drug Administration (FDA) has approved ALTUVIIIO<sup>™</sup> [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy. ALTUVIIIO is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A. ALTUVIIIO is the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis.

***Paul Hudson***

CEO, Sanofi

*"Today's approval of ALTUVIIIO allows patients and physicians to reimagine living with hemophilia. The high sustained factor activity levels that can be achieved with ALTUVIIIO have the potential to change the hemophilia landscape. For the first time, with a once-weekly dose, powerful bleed protection is a reality for patients. Significant shifts in treatment paradigms that improve people's lives, like ALTUVIIIO, are what we have committed to delivering at Sanofi."* 

Hemophilia A is a rare, lifelong condition in which the ability of a person's blood to clot properly is impaired, leading to excessive bleeds and spontaneous bleeds into joints that can result in joint damage and chronic pain, and potentially impact quality of life. The severity of hemophilia is determined by the level of clotting factor activity in a person's blood, and there is a negative correlation between risk of bleeding and factor activity levels.

***Lynn Malec, MD***

Medical Director of Comprehensive Center for Bleeding Disorders and Associate Investigator at The Versiti Blood Research Institute, and Associate Professor of Medicine and Pediatrics at The Medical College of Wisconsin

*"This approval marks an important clinical advancement for the hemophilia community because we have an option that can achieve higher levels of factor activity with a single simplified weekly dose. By maintaining high levels of factor activity throughout the week, patients can be confident in the bleed protection ALTUVIIIO offers."* 

This is the first approval of ALTUVIIIO. The FDA evaluated the application under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The FDA previously granted ALTUVIIIO <u>Breakthrough Therapy designation</u> in May 2022 – the first factor VIII therapy to receive this recognition – <u>Fast Track designation</u> in February 2021, and Orphan Drug designation in August 2017.

Regulatory submission in the EU is anticipated in the second half of 2023. The European Commission granted Orphan Drug designation in June 2019.

***ALTUVIIIO helps elevate expectations for hemophilia A by providing protection for longer***

The FDA approval is based on data from the pivotal XTEND-1 Phase 3 study recently published in *<u>The New England Journal of Medicine</u>*. Once-weekly ALTUVIIIO prophylaxis met the primary endpoint, providing significant bleed protection for people with severe hemophilia A with a mean

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annualized bleeding rate (ABR) of 0.70 (95% CI: 0.5-1.0) and a median ABR of 0.0 (Q1, Q3: 0.0, 1.0). ALTUVIIIO met the key secondary endpoint with a significant reduction of 77% in ABR versus prior factor prophylaxis based on an intra-patient comparison (95% CI:58%-87%).

Additional data showed prevention of joint bleeds with a median annualized joint bleeding rate of 0 (Q1, Q3: 0.0, 1.0). Treatment with ALTUVIIIO provided 100% resolution of target joints, which are joints that have recurrent bleeds (e.g., knee, ankle, or elbow). ALTUVIIIO provided mean factor VIII activity greater than 40% for most of the week and greater than 10% at Day 7; these levels were associated with a low bleed risk. In the study, ALTUVIIIO was well-tolerated and inhibitor development to factor VIII was not detected, although is possible following administration of ALTUVIIIO.

Additionally, interim data from XTEND-Kids showed that children younger than 12 years of age receiving once-weekly ALTUVIIIO for 26 weeks (n=23) experienced a mean ABR of 0.5 (95% CI: 0.2-1.3) and a median ABR of 0 (Q1, Q3: 0.0, 1.3). Safety results were consistent with data from the XTEND-1 trial. The full results from XTEND-Kids will be presented at a future medical meeting.

Across the studies, ALTUVIIIO has an established safety profile and there were no reports of factor VIII inhibitor development, although inhibitor formation is possible following administration of ALTUVIIIO. The most common side effects (>10%) of ALTUVIIIO are headache and arthralgia.

ALTUVIIIO is indicated for routine prophylaxis, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding. The simple recommended dose of 50 IU/kg is intended for all patients and for different clinical scenarios.

To ensure that patients have access to the improved bleed protection provided by ALTUVIIIO, Sanofi will price ALTUVIIIO at parity to the annual cost of treating a prophylaxis patient on Eloctate<sup>®</sup> [Antihemophilic Factor (Recombinant), Fc Fusion Protein]. Sanofi will also provide comprehensive patient support services and resources online and at 1.855.MyALTUVIIIO (855.692.5888). In the U.S., ALTUVIIIO is expected to be commercially available in April.

*About ALTUVIIIO<sup>™</sup>* 

ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] is a novel von Willebrand Factor (VWF) independent recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. ALTUVIIIO has a 3 to 4 fold longer half-life relative to standard and extended half-life factor VIII products. It is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN<sup>®</sup> polypeptides to extend its time in circulation.

*About the XTEND Clinical Programs* 

The XTEND clinical program is comprised of two Phase 3 trials in hemophilia A: XTEND-1 in people 12 years or older and XTEND-Kids in children younger than 12 years old. There is also an ongoing extension study (XTEND-ed).

The Phase 3 XTEND-1 study (NCT04161495) was an open-label, non-randomized interventional study assessing the safety, efficacy, and pharmacokinetics of once-weekly ALTUVIIIO in people 12 years of age or older (n=159) with severe hemophilia A who were previously treated with factor VIII replacement therapy. The study consisted of two parallel treatment arms — the prophylaxis Arm A (n=133), in which patients who had received prior factor VIII prophylaxis were treated with once-weekly intravenous ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks, and the on-demand Arm B (n=26), in which patients who had received prior on-demand factor VIII therapy began with 26 weeks of on-demand ALTUVIIIO (50 IU/kg), then switched to once-weekly prophylaxis with ALTUVIIIO (50 IU/kg) for an additional 26 weeks.

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The primary efficacy endpoint was the mean annualized bleeding rate (ABR) in Arm A, and the key secondary endpoint was an intra-patient comparison of ABR during the ALTUVIIIO weekly prophylaxis treatment period versus the prior factor VIII prophylaxis ABR for a subset of participants in Arm A who had participated in a previous observational study (Study 242HA201/OBS16221).

The XTEND-Kids study (NCT04759131) was an open-label, non-randomized interventional study of the safety, efficacy, and pharmacokinetics of once-weekly ALTUVIIIO in previously treated patients younger than 12 years of age (n=67) with severe hemophilia A. Patients received once-weekly ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks.

*About the Sanofi and Sobi collaboration* 

Sobi and Sanofi collaborate on the development and commercialization of Alprolix<sup>®</sup> and Elocta<sup>®</sup>/Eloctate<sup>®</sup>. The companies also collaborate on the development and commercialization of efanesoctocog alfa or ALTUVIIIO<sup>™</sup> in the US. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory.

*About Sobi<sup>®</sup>* 

Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East and Asia. In 2022, revenue amounted to SEK 18.8 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube.

*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* 

**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>

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

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

*Sobi Contacts:* 

*Media Relations* 

For Sobi Media contacts, click <u>here.</u>

*Investor Relations* 

For details on how to contact the Sobi Investor Relations Team, click <u>here.</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. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. 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, 2021. 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](g456470g0224111757509.jpg) |

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*FDA approves once-weekly ALTUVIIIO<sup>™</sup>, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection. This positive event triggers impairment reversal, impacting 2022 IFRS net income; no change on business net income (non-IFRS)* 

**Filing of the 2022 U.S. Form 20-F and French "Document d'Enregistrement Universel" containing the Annual Financial Report** 

**Paris, February 24, 2023.** Sanofi announces today the filing of its Form 20-F with the U.S. Securities and Exchange Commission (SEC) and its "Document d'Enregistrement Universel" containing its Annual Financial Report with the French market regulator Autorité des marchés financiers (AMF).

On February 22, 2023, the US Food and Drug Administration (FDA) approved ALTUVIIIO<sup>TM</sup>. This confirms the significant increase of value of the asset. That decision, which occurred prior to the filing of the French Document d'enregistrement universel and of the Annual Report on Form 20-F, resulted in an adjustment to IFRS net income for the year ended December 31, 2022 as presented in the Sanofi press release issued on February 3, 2023. The adjustment consisted of the reversal of €2,154 million of impairment losses against the intangible assets associated with the Eloctate franchise, in accordance with IAS 36 (Impairment of Assets); the assets had been partially written down in 2019. The adjustment is presented within the line item Impairment of intangible assets in the consolidated income statement; the net impact after tax is a gain of €1,651 million. Cash flows are not impacted by the adjustment. Following the adjustment, for the year ended December 31, 2022, IFRS net income amounts to €8,371 million (versus €6,720 million as per the press release of February 3, 2023); earnings per share (IFRS EPS) amounts to €6.69 (versus €5.37 as per the press release of February 3, 2023); and total equity amounts to €75,152 million (versus €73,512 million as per the press release of February 3, 2023).

Business net income (a non-IFRS financial measure) for the year ended December 31, 2022 is unchanged, as is the amount of the dividend proposed by the Board of Directors held on February 2, 2023.

*Updated IFRS figures for 2022 Financial Statements<sup>1</sup>* 

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
|  | **Q4 2022** | *Change* | <br> *Change*  | **2022** | *Change* | *Change* |
|  |  |  | *at CER* <br>|  |  | *at CER* <br>|
|  IFRS net sales reported | €10,725m | *+7.3%* | *+2.6%* | €42,997m | *+13.9%* | *+7.0%* |
|  IFRS net income reported | €3,111m | *+175.1%* |  | €8,371m | *+34.5%* | *—* |
|  IFRS EPS reported | €2.48 | *+175.9%* |  | €6.69 | *+34.6%* | *—* |
|  Free cash flow<sup>(2)</sup> | €2,546m | *+0.2%* |  | €8,483m | *+4.8%* | *—* |
|  Business operating income | €2,724m | *+20.7%* | *+15.0%* | €13,040m | *+21.7%* | *+13.3%* |
|  Business net income<sup>(1)</sup> | €2,141m | *+23.8%* | *+17.6%* | €10,341m | *+25.9%* | *+17.0%* |
|  Business EPS<sup>(1)</sup> | €1.71 | *+23.9%* | *+17.4%* | €8.26 | *+25.9%* | *+17.1%* |

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*Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9 of February 3, 2023 Press Release). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-IFRS financial measure (definition in Appendix 9 of February 3, 2023 Press Release). The reconciliation of reported IFRS net income to business net income is set forth in the 2022 U.S. Form 20-F page 62 and French "Document d'Enregistrement Universel" page 142; (2) Free cash flow is a non-IFRS financial measure (definition in Appendix 9 of February 3, 2023 Press Release).* 

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These documents are available on the company's website: <u>https://www.sanofi.com/en/investors/reports-and-publications/financial-and-csr-reports</u> .

In addition, the Form 20-F is available on the website of the SEC (<u>www.sec.gov</u>) and the "Document d'Enregistrement Universel" is available on the website of the AMF (<u>www.amf-france.org</u>). A hard copy of these documents, each of which contains our complete audited financial statements, may be received free of charge, upon request.

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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* 

**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>

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

**Kate Conway** \| + 1 508 364 4931 \| <u>kate.conway@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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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*1.* *Updated vs. February 3, 2023 press release* 

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## Exhibit 99.3

**Exhibit 99.3** 

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|:---|:---|
| **Press Release** | ![LOGO](g456470g0224111757509.jpg) |

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*New Phase 3 data presented at WORLDSymposium<sup>™</sup> reinforce Nexviazyme<sup>®</sup> (avalglucosidase alfa) as potential new standard of care for all people living with late-onset Pompe disease* 

**Paris, February 24, 2023.** Today, at WORLD*Symposium*<sup>TM</sup>, data from the Phase 3 COMET study long-term extension showed sustained treatment effect of Nexviazyme*<sup>®</sup>* (avalglucosidase alfa) over nearly three years in late-onset Pompe disease (LOPD) patients who were treatment-naïve as well as those who switched from long-time standard of care, alglucosidase alfa, during the 96-week extension period. Additionally, a separate analysis of respiratory function showed clinical benefit over two years for patients who switched to Nexviazyme regardless of prior response to alglucosidase alfa.

***Priya S. Kishnani, MD***

C.L. and Su Chen Professor of Pediatrics; Medical Director, YT and Alice Chen Pediatrics Genetics and Genomics Center; and Division Chief, Medical Genetics, Duke University Medical Center

*"The results presented at the 2023 WORLDSymposium continue to build on the data from the clinical trials on the value and long-term impact Nexviazyme may provide for a wide variety of people living with late-onset Pompe disease, from newly diagnosed patients to those who have been previously treated with alglucosidase alfa. Further, when examining patients treated with Nexviazyme who switched from using alglucosidase alfa, these data show clinical benefit both for patients who were stable on alglucosidase alfa and those who experienced sub-optimal response or decline."* 

***Bill Sibold***

Global Head of Specialty Care, Sanofi

*"These long-term data over nearly three years add to the robust body of evidence that consistently shows the clinical benefit and durability of effect of treatment with Nexviazyme for both treatment-experienced and treatment-naïve people living with late-onset Pompe disease. We continue to learn from our 20 years of experience in Pompe disease and build on our findings in an effort to advance the standard of care."* 

Nexviazyme is a monotherapy approved in the US and other markets for the treatment of LOPD. It is also approved for infantile-onset Pompe disease (IOPD) in certain markets outside of the US.

*Nexviazyme maintained treatment effect at 145 weeks* 

The Phase 3 COMET trial enrolled 100 previously untreated LOPD patients who were randomized to receive either Nexviazyme (20 mg/kg) or alglucosidase alfa (20 mg/kg) every two weeks for 49 weeks during the double-blind primary analysis period. During the open-label extension period, long-term efficacy and safety outcomes were assessed up to 145 weeks in patients who continued their treatment with Nexviazyme (n=51), as well as those who switched to treatment with Nexviazyme from alglucosidase alfa (n=44) at the conclusion of the primary analysis period (Week 49).

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After nearly three years (145 weeks), changes from baseline (least squares mean [standard error]) showed:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Patients who received continuous Nexviazyme treatment for 145 weeks experienced sustained improvements in respiratory
and motor function, showing a 1.40 (1.21) point improvement in forced vital capacity (FVC) percent-predicted and an average increase of 20.65 (9.60) meters in walking distance as measured by the six-minute walk test (6MWT), respectively, compared to baseline.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Patients who switched from alglucosidase alfa to Nexviazyme treatment during the extension period experienced
stabilization of treatment effect, showing a 1.18 (1.32) point improvement in FVC percent-predicted and an average increase of 0.29 (10.42) meters in walking distance (6MWT), compared to baseline.

The safety profile during treatment with Nexviazyme was comparable between both study groups (those who started Nexviazyme in the primary analysis period and those who switched to Nexviazyme during the extension period). No new safety signals were observed in patients who switched from alglucosidase alfa to Nexviazyme during the extension period. Across both Nexviazyme treatment groups, five patients discontinued treatment during the extension period due to six adverse events (AEs); four were treatment-related (ocular hyperemia, erythema, urticaria, respiratory distress), and two were non-treatment-related (acute myocardial infarction, pancreatic adenocarcinoma).

*Clinical benefits seen over two years for patients who switched to Nexviazyme* 

Subgroup analyses were also performed to assess respiratory function outcomes for the 44 patients who switched to Nexviazyme in the long-term extension period of the Phase 3 COMET study. Patients were divided into two subgroups, responders (n=14) and non-responders (n=30) based on individual responses to initial treatment with alglucosidase alfa, as measured by the change in FVC percent-predicted (ΔFVC %predicted/year) pre- (baseline-week 49) and post-switch (week 49-week 145). Findings showed clinical benefits over two years following switch to Nexviazyme regardless of prior response to alglucosidase alfa:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Patients who responded to alglucosidase alfa treatment in the primary analysis period had increased respiratory function
(Δ FVC slope, 4.67±1.28%/yr, p<0.001), which was maintained throughout the extension period with Nexviazyme treatment (Δ FVC slope,
0.14±0.94%/yr, p=0.88).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;● Patients who did not respond to alglucosidase alfa treatment in the primary analysis period had reduced respiratory
function while taking alglucosidase alfa (Δ FVC slope, -2.12±0.87%/yr, p=0.016); however, switching to Nexviazyme halted this decline in the
extension period (Δ FVC slope, 0.15±0.61%/yr, p=0.81).

*About Pompe disease* 

People living with Pompe disease have low levels of the enzyme acid alpha-glucosidase (GAA), which results in build-up of glycogen in muscle cells throughout the body, leading to irreversible damage to skeletal and cardiac muscles.

Pompe disease can present as infantile-onset Pompe disease (IOPD), the most severe form of the disease with rapid onset in infancy, or late-onset Pompe disease (LOPD), which progressively damages muscles over time. If left untreated, IOPD can lead to heart failure and death within the first year of life, while people living with LOPD may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility as the disease progresses.

*About Nexviazyme (avalglucosidase alfa)* 

Nexviazyme (avalglucosidase alfa) is an enzyme replacement therapy (ERT) designed to target the mannose-6-phosphate (M6P) receptor, the key pathway for uptake and transport of ERT. Nexviazyme aims to help improve uptake and enhance glycogen clearance in target tissues with an average 15-fold higher level of M6P moieties as compared to alglucosidase alfa, the comparator therapy in the pivotal study. Nexviazyme is approved in multiple markets around

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the world for the treatment of people living with Pompe disease, including the United States, the European Union, Japan, Canada, Switzerland, Australia, Brazil, Argentina, Taiwan, the United Arab Emirates, South Korea and the United Kingdom, with specific indications varying by country. In Europe, the medicine is marketed under the brand name Nexviadyme.

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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* 

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

**Kate Conway** \| + 1 508 364 4931 \| <u>kate.conway@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 and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. 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, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, 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. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly, and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. 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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