Form 6-K Sanofi For: May 16

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

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

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of May 2022

Commission File Number: 001-31368

SANOFI

(Translation of registrant’s name into English)

54, rue La Boétie, 75008 Paris, FRANCE

(Address of principal executive offices)

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): ________

In May 2022, Sanofi issued the document attached hereto as Exhibit 99.1 which is incorporated herein by reference.

Exhibit List

Exhibit Index

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.

Exhibit 99.1

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7)

Q1 2022 sales growth driven by Dupixent^® and CHC

Q1 2022 business EPS⁽¹⁾ up 16.1% at CER driven by higher sales and improving margins

Key milestone and regulatory achievements on R&D transformation

(1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7). The consolidated income statement for Q1 2022 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2021 business EPS was €6.56.

2022 first-quarter Sanofi sales

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Unless otherwise indicated, all percentage changes in sales in this document are stated at CER¹

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In the first quarter of 2022, Sanofi sales were €9,674 million, up 12.6% on a reported basis. Exchange rate movements had a positive effect of 4.0 percentage points, mainly due to the U.S. dollar.

Global Business Units

First-quarter 2022 net sales by Global Business Unit (variation at CER; € million; % of total sales)

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First-quarter 2022 net sales by geographic region (variation at CER; € million; % of total sales)

First-quarter 2022 operating income

First-quarter business operating income (BOI) increased.. The ratio of BOI to net sales increased 1.0 percentage point to 31.7%.

Pharmaceuticals

First-quarter 2022 Pharmaceutical sales increased 7.5% to €7,326 million, mainly driven by the Specialty Care portfolio (up 17.8%) with continued strong performance of Dupixent^® while sales in General Medicines decreased 0.7%.

Specialty Care

Dupixent

In the first quarter, Dupixent^® (collaboration with Regeneron) sales increased 45.7% to €1,614 million. In the U.S., Dupixent^® sales of €1,176 million (up 38.1%) were driven by continued strong demand in AD in adults, adolescents, and children aged 6 to 11 years, and continued uptake in asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent^® total prescriptions (TRx) increased 43% (year-over-year) and new-to-brand prescriptions (NBRx) grew 32%. In Europe, first-quarter Dupixent^® sales

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grew 53.3% to €211 million reflecting continued growth in AD and additional launches in younger population in AD, asthma and CRSwNP.

Neurology and Immunology

In the first quarter, Neurology and Immunology sales grew 0.3% to €611 million, reflecting strong Kevzara^® sales which were partially offset by lower Aubagio^® sales.

Aubagio^® sales decreased 6.6% in the first quarter to €491 million due to lower sales in the U.S. as a result of both competitive pressure and price. Sales in Europe were stable.

First-quarter Kevzara^® (collaboration with Regeneron) sales increased 61.4% to €95 million due to a COVID-19 related increase in global demand for IL-6 receptor blockers and the temporary tocilizumab shortage.

Rare Disease

In the first quarter, Rare Disease sales increased 1.9% to €804 million driven by the Pompe franchise, partially offset by unfavorable purchasing patterns in Rest of the World region primarily for the Gaucher and Fabrazyme franchises. Underlying patients base treated grew around 6% compared to the same quarter of last year.

First-quarter sales of the Pompe franchise (Myozyme/Lumizyme^® + Nexviazyme^®) increased 8.9% to €265 million primarily from new patient accruals and the ramp up of Nexviazyme^®. Myozyme^®/Lumizyme^® sales decreased 3.0% to €235 million mainly reflecting the conversion to Nexviazyme^® in the U.S. Sales of Nexviazyme^® (which was launched in the US in August 2021 and in Japan in November 2021) were €30 million in the first quarter (of which €26 million in the U.S.).

Sales of the Gaucher franchise (Cerezyme^® + Cerdelga^®) decreased 4.2% (to €232 million) in the first quarter. Over the period, Cerezyme^® sales decreased 6.7% to €165 million, mainly due to unfavorable buying patterns resulting in lower sales in the Rest of the World region. In parallel, Cerdelga^® sales were up 3.2% driven by switches and new patient accruals in Europe and the U.S.

First-quarter Fabrazyme^® sales increased 2.4% to €220 million driven mainly by Europe and the U.S. In the Rest of the World region, despite unfavorable purchasing patterns, Fabrazyme^® sales were stable.

Oncology

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First-quarter 2022 sales of Oncology increased 6.8% (to €244 million) driven by the Sarclisa^® launch which more than offset the impact of Jevtana^® generic competition in Europe.

First-quarter Jevtana^® sales decreased 25.4% to €98 million following the entry of generic competition in some European markets (down 75.6%) at the end of March 2021. In the U.S., sales were up 8.6%, where Jevtana^® is currently covered by four Orange Book listed patents US 7,241,907, US 8,927,592, US 10,583,110 and US 10,716,777. Sanofi filed patent infringement suits under Hatch-Waxman against generic filers asserting the ‘110 patent, the ‘777 patent and the ‘592 patent in the US District Court for the District of Delaware. Sanofi has reached settlement agreements with some of the defendants and the suit against the remaining defendants is ongoing. A 3-day trial against Apotex and Sandoz has been scheduled starting January 2023 and the remaining defendants have agreed not to launch any generic cabazitaxel product until the earlier of a district court decision in favor of the defendants or four months after the completion of the post-trial briefing. Jevtana^® also received a regulatory data exclusivity related to the CARD clinical study which expires in December 2023.

First-quarter Sarclisa^® sales were €65 million (versus €34 million in the first quarter of 2021) primarily driven by performance in the U.S. (€25 million), Europe (€22 million) and Japan.

Rare Blood Disorders

In the first quarter, Rare Blood Disorders franchise sales increased 1.8% (€293 million), reflecting Cablivi^® and Alprolix^® growth partially offset by lower Eloctate^®/Alprolix^® industrial sales to Sobi (recorded in the Rest of the World region).

Eloctate^® sales were €138 million in the first quarter, down 3.0% reflecting lower sales in the U.S. (down 1.9%) and in the Rest of the World region.

First-quarter Alprolix^® sales were up 2.0% to €108 million driven by the U.S. sales (up 8.9%), partially offset by lower sales in the Rest of the World region.

Cablivi^® sales increased by 15.8% to €46 million in the first quarter driven by launches in Europe (up 46.7% to €23 million). In the U.S., sales of the product were down 4.5% to €22 million, due to the COVID-19 environment impacting treatment initiations at the hospital level.

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General Medicines

First quarter General Medicines sales decreased 0.7% to €3,760 million and were stable excluding portfolio streamlining.

Core assets

In the first quarter, core assets sales increased 4.7% to €1,594 million, driven by Toujeo^®, Praluent^®, Multaq^®, Thymoglobulin^® and Rezurock^® (consolidated from November 9, 2021), partially offset by lower sales of Lovenox^®. Core assets sales grew across all geographies in the first quarter.

First-quarter Lovenox^® sales decreased 8.2% to €377 million, mainly reflecting lower sales in the Rest of the World region (down 11.9%) due to high base of comparison in the first quarter of 2021 which benefitted from strong Covid-related demand (WHO guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients). In addition, biosimilar competition and supply limitations affected the performance.

First-quarter Toujeo^® sales increased 6.3% to €274 million due to growth in Europe and the Rest of the World region, partially offset by lower sales in the U.S.

In China, the Volume Based Procurement (VBP) for insulins is expected to be implemented in May 2022. In November 2021, Sanofi participated in the VBP tender for basal insulin analogues and was among the bidding winners in the group A with Lantus^®/Toujeo^®. Sanofi expects its glargine (Toujeo^®/Lantus^®) sales to decrease in China in 2022, due to high volumes at significantly lower prices. In China, Toujeo^®/Lantus^® sales were €459 million in 2021.

Plavix^® sales were stable in the first quarter to €261 million, higher sales in the Rest of the World region (up 1.4%) offsetting lower sales in Europe. Plavix^® sales in China were down 3.4% to €123 million due to a high base of comparison in the first quarter of 2021.

Multaq^® first quarter sales grew 13.9% to €87 million, reflecting strong U.S. sales growth.

Sales of Rezurock^®, a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy, were consolidated as of November 9, 2021 (through the Kadmon acquisition) and generated €41 million in the first quarter. Rezurock^® performance reflects the rapidly expanding pool of prescribing institutions as well as pent-up demand from cGVHD patients who have already failed multiple systemic therapies.

Praluent^® first-quarter sales were €69 million, up 21.4% driven by Europe performance. In Rest of the World region, sales were up 6.7%. In China, Praluent^® was included in the NDRL list at the beginning of 2022.

First-quarter Soliqua^® sales increased 15.9% to €53 million driven by the Rest of World region (up 54.5%) supported by new launches and Solimix results.

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Non-core assets

In the first quarter, non-core assets sales decreased 4.2% to €1,983 million reflecting portfolio streamlining (-1.4ppt), lower Lantus^® sales as well as the impact of VBP wave 5 in China on Eloxatin^® and Taxotere^® sales.

Lantus^® sales were €671 million, down 1.5% in the first quarter, due to lower sales in Europe, reflecting biosimilar competition and continuous Toujeo^® switches.

First-quarter Aprovel^®/Avapro^® sales were up 17.8% to €125 million, due to some supply improvement and compared with a low base in the first quarter of 2021.

Pharmaceuticals business operating income

In the first quarter, business operating income (BOI) of Pharmaceuticals increased. The ratio of BOI to net sales increased by 0.3 percentage point to 38.6%, reflecting an improvement of the gross margin ratio.

Vaccines

First-quarter Vaccines sales increased 6.8% to €1,020 million driven by double-digit growth of Polio/Pertussis/Hib vaccines sales and partial recovery of Travel vaccines.

In the first quarter, Polio/Pertussis/Hib (PPH) vaccines sales increased 10.3% to €613 million. In the Rest of the World region, PPH sales grew 23.1% driven by a strong performance of Pentaxim^® in China compared to a low base last year and favorable timing of polio tender delivery. In the U.S., PPH sales were impacted by inventory fluctuation and progressive ramp up of Vaxelis^® sales. As a reminder, Vaxelis^® in-market sales are not consolidated and the profits are shared equally between Sanofi and Merck.

First-quarter Meningitis sales decreased 16.4% to €112 million, due to lower sales in Latin America reflecting price competition in public tenders.

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Booster vaccines sales increased 4.0% in the first quarter to €109 million, driven by the Rest of the World region.

First-quarter Travel and endemic vaccines sales increased 61.0% to €98 million, reflecting a partial recovery of Travel vaccines in Europe and the U.S. as well as higher endemic vaccines sales in the Rest of the World region.

Influenza vaccines sales decreased 18.2% in the first quarter, reaching €66 million due to an exceptional high demand in the first quarter of 2021.

Vaccines business operating income

In the first quarter, business operating income (BOI) decreased compared to the same period of last year. This reflects higher R&D expenses related to Translate Bio and the mRNA center of excellence and the payment from Daiichi Sankyo recorded in the first quarter of 2021. BOI to net sales ratio was 29.0% (versus 40.5% in the first quarter of 2021, 27.5% excluding the payment from Daiichi Sankyo).

Consumer Healthcare

In the first quarter, Consumer Healthcare (CHC) sales increased 17.0% to €1,328 million sustained by growth in Europe and the Rest of the World region. This performance was mainly driven by the strong demand for Cough & Cold products, as well as the performance of Pain Care and Digestive Wellness categories. This global performance includes a positive price effect of 3%. The divestments of non-core products had an impact of -0.6 ppt of growth in the first quarter.

In the U.S., first-quarter CHC sales increased 2.1% to €310 million driven by double-digit growth of Allergy category partially offset by lower sales of Personal care and non-core assets mainly due to supply constraints.

In Europe, first-quarter CHC sales increased 21.0% to €406 million mainly reflecting strong growth of the Cough & Cold and Pain Care categories.

In Rest of World, first-quarter CHC sales increased 22.8% to €612 million, supported by growth in all categories.

CHC business operating income

In the first quarter, business operating income (BOI) of CHC increased. The ratio of BOI to net sales increased 9.5 percentage point to 44.9% versus the prior year, reflecting strong top line growth as well as a capital gain related to divestments of non-strategic assets.

Company sales by geographic region

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First-quarter sales in the U.S. increased +12.1% to €3,484 million supported by the strong performance of Dupixent^®.

In Europe sales increased +6.7% in the first quarter to €2,392 million mainly driven by Dupixent^® performance as well as strong CHC growth.

In Rest of World sales increased +7.0% to €3,798 million in the first quarter, reflecting the performance of Dupixent^®, CHC and Vaccines which largely offset lower sales of General Medicines. Sales in China increased 13.4% to €901 million mainly as a result of the growth of Dupixent^®, Vaccines and CHC. In Japan, first-quarter sales increased 1.6% to €433 million driven by Dupixent^® and Sarclisa^® which more than offset lower sales of General Medicines. In Russia, due to strong cough, cold and flu related sales, higher vaccines sales and unprecedented stockpiling at pharmacy and patient level sales increased 34.4% in the first quarter. In March, Sanofi decided to stop any new spending not related to the supply of its essential and life-changing medicines and vaccines in Russia. This includes all advertising and promotional spending.

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R&D update at the end of the first quarter 2022

Regulatory update

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Portfolio update

Phase 3:

Phase 2:

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Phase 1:

Given the war in Ukraine and the suffering of the Ukrainian people, Sanofi has adapted its clinical trial implementation in the region. The company decided to halt any new recruitment of patients for ongoing clinical trials in Russia and Belarus, though it will continue to treat patients already enrolled. In Ukraine, Sanofi seeks to continue to support and supply patients currently enrolled in Sanofi-sponsored clinical trials, including transferring them within Ukraine or into neighboring countries. In anticipation of potential loss of data, the company is currently activating new clinical sites and expanding patient enrollment in geographies not impacted by the war. This may lead to the planned primary completion dates of its pivotal trials in MS and COPD to shift, but previously communicated submission timelines remain unchanged.

Acquisitions and major collaborations

An update of the R&D pipeline at as of March 31, 2022, is available on Sanofi’s website:

https://www.sanofi.com/en/science-and-innovation/research-and-development

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Covid Update

Sanofi and GSK applied for regulatory authorization of their first-generation COVID-19 vaccine in Europe with data supporting its use as a universal booster, designed to boost all currently approved COVID-19 vaccine platforms. In addition, the companies are developing a next-generation booster vaccine designed to provide broad protection against all variants of concern, from the original strain to Omicron BA.2. The data (VAT02 Cohort 2) is expected to be communicated in Q2 2022.

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First-quarter 2022 financial results

Business Net Income²

In the first quarter of 2022, Sanofi generated net sales of €9,674 million, an increase of 12.6% (up 8.6% at CER).

First-quarter other revenues increased 28.5% (up 23.7% at CER) to €379 million, including VaxServe sales contribution of non-Sanofi products of €286 million (up 16.7 % at CER).

First-quarter Gross Profit increased 15.7% (up 11.1% at CER) to €7,175 million. The gross margin ratio increased 2.0 percentage points to 74.2% versus the first quarter of 2021, reflecting strong improvement of the Pharmaceuticals gross margin ratio (which increased from 75.2% to 77.9%) driven by favorable impact of growing weight of Specialty Care, efficiency gains in Industrial Affairs and lower royalty expenses. The Vaccines gross margin ratio slightly decreased to 61.6% from 62.0%. CHC gross margin ratio was 67.3%, down 0.7 percentage point.

Research and Development (R&D) expenses increased 17.5% (up 14.0% at CER) to €1,489 million in the first quarter, reflecting increase in priority assets development as well as recent acquisitions.

First-quarter selling general and administrative expenses (SG&A) increased 8.4% to €2,379 million. At CER, SG&A expenses were up 4.3%, reflecting increased commercial investments in Specialty Care growth drivers which were partially offset by continued streamlining initiatives. In the first quarter, the ratio of SG&A to sales decreased 0.9 percentage point to 24.6% compared to the prior year.

First-quarter operating expenses were €3,868 million, an increase of 11.8% and 7.8% at CER.

First-quarter other current operating income net of expenses was -€265 million versus -€101 million in the first quarter of 2021. Other current operating income net of expenses included an expense of €477 million (versus an expense of €279 million in the first quarter of 2021) corresponding to the share of profit to Regeneron of the monoclonal antibodies Alliance, reimbursement of development costs by Regeneron and the reimbursement of commercialization-related expenses incurred by Regeneron. In the first quarter, this line also included €232 million of net capital gains related to General Medicines and CHC portfolio streamlining compared to €56million in the same period of 2021.

The share of profit from associates was €30 million versus €9 million in the first quarter of 2021 and included the share of U.S profit related to Vaxelis^®.

First-quarter business operating income² (BOI) increased. . The ratio of BOI to net sales increased 1.0 percentage point to 31.7% mainly reflecting gross margin ratio improvement.

Net financial expenses were €78 million versus €84 million in the same period of 2021.

First-quarter effective tax rate was 19.0% versus 21.0% in the prior year. Sanofi expects its effective tax rate to be around 19% in 2022.

First-quarter business net income² increased 20.2% to €2,424 million and increased 16.0% at CER. The ratio of business net income to net sales increased 1.6 percentage point to 25.1% versus the first quarter of 2021.

In the first quarter of 2022, business earnings per share² (EPS) was €1.94, up 20.5% on a reported basis (up 16.1% at CER). The average number of shares outstanding was 1,249.2 million versus 1,249.3 million in first quarter 2021.

Reconciliation of IFRS net income reported to business net income (see Appendix 4)

² See Appendix 3 for 2021 first-quarter consolidated income statement; see Appendix 7 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income.

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In the first quarter of 2022, the IFRS net income was €2,009 million. The main items excluded from the business net income were:

Capital Allocation

In the first quarter of 2022, free cash flow before restructuring, acquisitions and disposals⁴ decreased by 15.5% to €1,998 million, after net changes in working capital (-€468 million) and capital expenditures (-€356 million). After acquisitions (-€277 million), proceeds from disposals³ (+€347 million) and payments related to restructuring and similar items (-€361 million), free cash flow⁴ decreased by 11.3% to €1,707 million. After the acquisition of Amunix (-€803 million), net debt decreased from €9,983 million at December 31, 2021 to €9,432 million at March 31, 2022 (amount net of €8,728 million cash and cash equivalents).

³ Not exceeding €500 million per transaction (inclusive of all payments related to the transaction).

⁴ Non-GAAP financial measure (definition in Appendix 7).

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Forward-Looking Statements

This document 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”, “expected to”, “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, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Appendices

Media Relations

Sandrine Guendoul | + 33 6 25 09 14 25 | [email protected]

Nicolas Obrist | + 33 6 77 21 27 55 | [email protected]

Victor Rouault | + 33 6 70 93 71 40 | [email protected]

Sally Bain | + 1 617 834 6026 | [email protected]

Investor Relations

Eva Schaefer-Jansen | + 33 7 86 80 56 39 | [email protected]

Arnaud Delépine | + 33 6 73 69 36 93 | [email protected]

Corentine Driancourt | + 33 6 40 56 92 | [email protected]

Felix Lauscher | + 1 908 612 7239 | [email protected]

Priya Nanduri | +1 617 764 6418 | [email protected]

Nathalie Pham | + 33 7 85 93 30 17 | [email protected]

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Appendix 1: 2022 first-quarter net sales by GBU, franchise, geographic region and product

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Appendix 2: Business net income statement

* Net of tax.

** Determined on the basis of Business income before tax, associates, and non-controlling interests.

*** Based on an average number of shares outstanding of 1,249.2 million in the first quarter of 2022 and 1,249.3 million in the first quarter of 2021.

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Appendix 3: Consolidated income statements