Sanofi continues to deliver strong business EPS growth driven by higher sales and improved margins in Q1

Q1 2022 sales growth of 8.6% at CER driven by Dupixent^® and CHC

• Specialty Care grew 17.8% driven by Dupixent^® (€1,614 million, +45.7%)
• Vaccines were up 6.8% reflecting strong PPH franchise as well as gradual recovery of Travel vaccines
• General Medicines core assets up 4.7% driven by Rezurock^® and overall GBU sales broadly stable (-0.7%)
• CHC continued strong growth momentum (+17.0%) driven by Cough & Cold and Pain care categories

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

• BOI margin reached 31.7% up 1.0 ppt reflecting improvement in gross margin while investing in R&D
• Business EPS⁽¹⁾ of €1.94, up 20.5% on a reported basis and 16.1% at CER, also benefitting from an improved effective tax rate
• IFRS EPS of €1.61 (up 28.8%)

Progress on Corporate Social Responsibility strategy

• Sanofi continues its progress to improve access to medicines; issuing a sustainability-linked bond and publishing its global access and pricing policy
• Sanofi is working with experts from leading oncology institutions to reach its CSR ambitions on childhood cancer

Key milestone and regulatory achievements on R&D transformation

• Efanesoctocog alfa met phase 3 primary endpoint in hemophilia A and demonstrated superiority to prior factor prophylaxis
• Dupixent^® approved in EU for severe asthma in children aged 6 to 11 years; Priority Review obtained in atopic dermatitis for children (6 months to 5 years) and eosinophilic esophagitis patients 12 years and older in the U.S.
• Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants
• FDA approved Enjaymo™, first treatment for use in patients with cold agglutinin disease (CAD)
• Xenpozyme^® approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency (ASMD)
• Sanofi and GSK applied for conditional regulatory authorization for 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

2022 financial outlook

• Sanofi expects 2022 business EPS⁽¹⁾ to grow low double-digit⁽²⁾ at CER, barring unforeseen major adverse events. Applying average April 2022 exchange rates, the positive currency impact on 2022 business EPS is estimated to be between +4% to +5%

Sanofi Chief Executive Officer, Paul Hudson, commented:

“We are off to a strong start to 2022 propelled by the continued outstanding performance of Dupixent^®, double-digit growth of our CHC business and improved margins in the first quarter. In R&D, we increased our investments to fuel our rapidly advancing pipeline which was further enhanced through BD collaborations such as Seagen, IGM, Exscientia and Blackstone during the period. As highlighted at our investor event in March, we remain focused on our path to industry leadership in Immunology with a broad set of novel treatments in development, including additional indications for Dupixent^® in diseases such as Prurigo Nodularis and Eosinophilic Esophagitis which were recently submitted for regulatory approval. In addition, we are particularly excited about the positive pivotal trial readout for efanesoctogog alfa, our potentially revolutionizing treatment for Hemophilia A patients, with its filing planned for mid-year. Also in the quarter, we continued to execute well against our strategic priorities with our decision for the proposed EUROAPI shares listing and spin-off through an extraordinary dividend. Based on the strong first quarter, we are on track to deliver on our 2022 financial guidance, despite the challenging business environment.“

READ ALSO: Sanofi delivered close to double-digit Q4 2020 business EPS growth at CER

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

(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; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 7).

2022 first-quarter Sanofi sales

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Unless otherwise indicated, all percentage changes in sales in this press release 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. At CER, company sales were up 8.6%.

Global Business Units

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

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 16.2% to €3,065 million. At CER, BOI increased 12.2%. The ratio of BOI to net sales increased 1.0 percentage point to 31.7% (31.7% at CER).

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 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

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.

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 that its glargine (Toujeo^®/Lantus^®) sales to decrease by around 30% in China in 2022, benefitting from 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.

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 12.6% to €2,831 million (up 8.8% at CER). The ratio of BOI to net sales increased by 0.3 percentage point to 38.6% (38.8% at CER), reflecting an improvement of the gross margin ratio.

Vaccines