Sanofi continues to ship sturdy enterprise

Sanofi continues to ship sturdy enterprise EPS⁽¹⁾ development pushed by greater gross sales and improved margins in Q1 

Paris, April 28, 2022

Q1 2022 gross sales development of 8.6% at CER pushed by Dupixent^® and CHC

• Specialty Care grew 17.8% pushed by Dupixent^® (€1,614 million, +45.7%)
• Vaccines have been up 6.8% reflecting sturdy PPH franchise in addition to gradual restoration of Journey vaccines
• Normal Medicines core property up 4.7% pushed by Rezurock^® and total GBU gross sales broadly steady (-0.7%)
• CHC continued sturdy development momentum (+17.0%) pushed by Cough & Chilly and Ache care classes

Q1 2022 enterprise EPS⁽¹⁾ up 16.1% at CER pushed by greater gross sales and bettering margins

• BOI margin reached 31.7% up 1.0 ppt reflecting enchancment in gross margin whereas investing in R&D
• Enterprise EPS⁽¹⁾ of €1.94, up 20.5% on a reported foundation and 16.1% at CER, additionally benefitting from an improved efficient tax fee
• IFRS EPS of €1.61 (up 28.8%)

Progress on Company Social Accountability technique

• Sanofi continues its progress to enhance entry to medicines; issuing a sustainability-linked bond and publishing its world entry and pricing coverage
• Sanofi is working with consultants from main oncology establishments to succeed in its CSR ambitions on childhood most cancers

Key milestone and regulatory achievements on R&D transformation

• Efanesoctocog alfa met section 3 major endpoint in hemophilia A and demonstrated superiority to prior issue prophylaxis
• Dupixent^® permitted in EU for extreme bronchial asthma in youngsters aged 6 to 11 years; Precedence Evaluate obtained in atopic dermatitis for youngsters (6 months to five years) and eosinophilic esophagitis sufferers 12 years and older within the U.S.
• Nirsevimab EMA regulatory submission accepted underneath accelerated evaluation for RSV safety in all infants
• FDA permitted Enjaymo™, first therapy to be used in sufferers with chilly agglutinin illness (CAD)
• Xenpozyme^® permitted in Japan, first and solely permitted remedy indicated to deal with acid sphingomyelinase deficiency (ASMD)
• Sanofi and GSK utilized for conditional regulatory authorization for his or her first-generation COVID-19 vaccine in Europe with information supporting its use as a common booster, designed to spice up all at the moment permitted COVID-19 vaccine platforms

2022 monetary outlook

• Sanofi expects 2022 enterprise EPS⁽¹⁾ to develop low double-digit⁽²⁾ at CER, barring unexpected main adversarial occasions. Making use of common April 2022 change charges, the constructive forex impression on 2022 enterprise EPS is estimated to be between +4% to +5%

Sanofi Chief Govt Officer, Paul Hudson, commented:

“We’re off to a powerful begin to 2022 propelled by the continued excellent efficiency of Dupixent^®, double-digit development of our CHC enterprise and improved margins within the first quarter. In R&D, we elevated our investments to gasoline our quickly advancing pipeline which was additional enhanced by way of BD collaborations corresponding to Seagen, IGM, Exscientia and Blackstone through the interval. As highlighted at our investor occasion in March, we stay centered on our path to trade management in Immunology with a broad set of novel therapies in improvement, together with further indications for Dupixent^® in ailments corresponding to Prurigo Nodularis and Eosinophilic Esophagitis which have been lately submitted for regulatory approval. As well as, we’re notably excited in regards to the constructive pivotal trial readout for efanesoctogog alfa, our probably revolutionizing therapy for Hemophilia A sufferers, with its submitting deliberate for mid-year. Additionally within the quarter, we continued to execute nicely towards our strategic priorities with our resolution for the proposed EUROAPI shares itemizing and spin-off by way of a rare dividend. Primarily based on the sturdy first quarter, we’re on observe to ship on our 2022 monetary steering, regardless of the difficult enterprise setting.“

Modifications in web gross sales are expressed at fixed change charges (CER) until in any other case indicated (definition in Appendix 7)

(1) So as to facilitate an understanding of operational efficiency, Sanofi feedback on the enterprise web earnings assertion. Enterprise web earnings is a non-GAAP monetary measure (definition in Appendix 7). The consolidated earnings assertion for Q1 2022 is supplied in Appendix 3 and a reconciliation of reported IFRS web earnings to enterprise web earnings is ready forth in Appendix 4; (2) 2021 enterprise EPS was €6.56; (3) Free money stream is a non-GAAP monetary measure (definition in Appendix 7).

2022 first-quarter Sanofi gross sales

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Except in any other case indicated, all share modifications in gross sales on this press launch are said at CER¹

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Within the first quarter of 2022, Sanofi gross sales have been €9,674 million, up 12.6% on a reported foundation. Change fee actions had a constructive impact of 4.0 share factors, primarily because of the U.S. greenback. At CER, firm gross sales have been up 8.6%.

International Enterprise Items

First-quarter 2022 working earnings

First-quarter enterprise working earnings (BOI) elevated 16.2% to €3,065 million. At CER, BOI elevated 12.2%. The ratio of BOI to web gross sales elevated 1.0 share level to 31.7% (31.7% at CER).

Prescribed drugs

First-quarter 2022 Pharmaceutical gross sales elevated 7.5% to €7,326 million, primarily pushed by the Specialty Care portfolio (up 17.8%) with continued sturdy efficiency of Dupixent^® whereas gross sales in Normal Medicines decreased 0.7%.

Specialty Care

Dupixent

Within the first quarter, Dupixent^® (collaboration with Regeneron) gross sales elevated 45.7% to €1,614 million. Within the U.S., Dupixent^® gross sales of €1,176 million (up 38.1%) have been pushed by continued sturdy demand in AD in adults, adolescents, and youngsters aged 6 to 11 years, and continued uptake in bronchial asthma and continual rhinosinusitis with nasal polyposis (CRSwNP). Dupixent^® whole prescriptions (TRx) elevated 43% (year-over-year) and new-to-brand prescriptions (NBRx) grew 32%. In Europe, first-quarter Dupixent^® gross sales grew 53.3% to €211 million reflecting continued development in AD and extra launches in youthful inhabitants in AD, bronchial asthma and CRSwNP.

Neurology and Immunology

Within the first quarter, Neurology and Immunology gross sales grew 0.3% to €611 million, reflecting sturdy Kevzara^® gross sales which have been partially offset by decrease Aubagio^® gross sales.

Aubagio^® gross sales decreased 6.6% within the first quarter to €491 million because of decrease gross sales within the U.S. on account of each aggressive strain and value. Gross sales in Europe have been steady.

First-quarter Kevzara^® (collaboration with Regeneron) gross sales elevated 61.4% to €95 million because of a COVID-19 associated enhance in world demand for IL-6 receptor blockers and the momentary tocilizumab scarcity.

Uncommon Illness

Within the first quarter, Uncommon Illness gross sales elevated 1.9% to €804 million pushed by the Pompe franchise, partially offset by unfavorable buying patterns in Remainder of the World area primarily for the Gaucher and Fabrazyme franchises. Underlying sufferers base handled grew round 6% in comparison with the identical quarter of final 12 months.

First-quarter gross sales of the Pompe franchise (Myozyme/Lumizyme^® + Nexviazyme^®) elevated 8.9% to €265 million primarily from new affected person accruals and the ramp up of Nexviazyme^®. Myozyme^®/Lumizyme^® gross sales decreased 3.0% to €235 million primarily reflecting the conversion to Nexviazyme^® within the U.S. Gross sales of Nexviazyme^® (which was launched within the US in August 2021 and in Japan in November 2021) have been €30 million within the first quarter (of which €26 million within the U.S.).

Gross sales of the Gaucher franchise (Cerezyme^® + Cerdelga^®) decreased 4.2% (to €232 million) within the first quarter. Over the interval, Cerezyme^® gross sales decreased 6.7% to €165 million, primarily because of unfavorable shopping for patterns leading to decrease gross sales within the Remainder of the World area. In parallel, Cerdelga^® gross sales have been up 3.2% pushed by switches and new affected person accruals in Europe and the U.S.

First-quarter Fabrazyme^® gross sales elevated 2.4% to €220 million pushed primarily by Europe and the U.S. Within the Remainder of the World area, regardless of unfavorable buying patterns, Fabrazyme^® gross sales have been steady.

Oncology

First-quarter 2022 gross sales of Oncology elevated 6.8% (to €244 million) pushed by the Sarclisa^® launch which greater than offset the impression of Jevtana^® generic competitors in Europe.

First-quarter Jevtana^® gross sales decreased 25.4% to €98 million following the entry of generic competitors in some European markets (down 75.6%) on the finish of March 2021. Within the U.S., gross sales have been up 8.6%, the place Jevtana^® is at the moment coated by 4 Orange Guide listed patents US 7,241,907, US 8,927,592, US 10,583,110 and US 10,716,777. Sanofi filed patent infringement fits underneath Hatch-Waxman towards generic filers asserting the ‘110 patent, the ‘777 patent and the ‘592 patent within the US District Court docket for the District of Delaware. Sanofi has reached settlement agreements with among the defendants and the swimsuit towards the remaining defendants is ongoing. A 3-day trial towards Apotex and Sandoz has been scheduled beginning January 2023 and the remaining defendants have agreed to not launch any generic cabazitaxel product till the sooner of a district courtroom resolution in favor of the defendants or 4 months after the completion of the post-trial briefing. Jevtana^® additionally acquired a regulatory information exclusivity associated to the CARD scientific research which expires in December 2023.

First-quarter Sarclisa^® gross sales have been €65 million (versus €34 million within the first quarter of 2021) primarily pushed by efficiency within the U.S. (€25 million), Europe (€22 million) and Japan.

Uncommon Blood Problems

Within the first quarter, Uncommon Blood Problems franchise gross sales elevated 1.8% (€293 million), reflecting Cablivi^® and Alprolix^® development partially offset by decrease Eloctate^®/Alprolix^® industrial gross sales to Sobi (recorded within the Remainder of the World area).

Eloctate^® gross sales have been €138 million within the first quarter, down 3.0% reflecting decrease gross sales within the U.S. (down 1.9%) and within the Remainder of the World area.

First-quarter Alprolix^® gross sales have been up 2.0% to €108 million pushed by the U.S. gross sales (up 8.9%), partially offset by decrease gross sales within the Remainder of the World area.

Cablivi^® gross sales elevated by 15.8% to €46 million within the first quarter pushed by launches in Europe (up 46.7% to €23 million). Within the U.S., gross sales of the product have been down 4.5% to €22 million, because of the COVID-19 setting impacting therapy initiations on the hospital degree.

Normal Medicines

First quarter Normal Medicines gross sales decreased 0.7% to €3,760 million and have been steady excluding portfolio streamlining.

Core property

Within the first quarter, core property gross sales elevated 4.7% to €1,594 million, pushed by Toujeo^®, Praluent^®, Multaq^®, Thymoglobulin^® and Rezurock^® (consolidated from November 9, 2021), partially offset by decrease gross sales of Lovenox^®. Core property gross sales grew throughout all geographies within the first quarter.

First-quarter Lovenox^® gross sales decreased 8.2% to €377 million, primarily reflecting decrease gross sales within the Remainder of the World area (down 11.9%) because of excessive base of comparability within the first quarter of 2021 which benefitted from sturdy Covid-related demand (WHO tips recommending the usage of low molecular weight heparins in hospitalized COVID-19 sufferers). As well as, biosimilar competitors and provide limitations affected the efficiency.

First-quarter Toujeo^® gross sales elevated 6.3% to €274 million because of development in Europe and the Remainder of the World area, partially offset by decrease gross sales within the U.S.

In China, the Quantity Primarily based Procurement (VBP) for insulins is predicted to be carried out in Could 2022. In November 2021, Sanofi participated within the VBP tender for basal insulin analogues and was among the many bidding winners within the group A with Lantus^®/Toujeo^®. Sanofi expects that its glargine (Toujeo^®/Lantus^®) gross sales to lower by round 30% in China in 2022, benefitting from excessive volumes at considerably decrease costs. In China, Toujeo^®/Lantus^® gross sales have been €459 million in 2021.

Plavix^® gross sales have been steady within the first quarter to €261 million, greater gross sales within the Remainder of the World area (up 1.4%) offsetting decrease gross sales in Europe. Plavix^® gross sales in China have been down 3.4% to €123 million because of a excessive base of comparability within the first quarter of 2021.

Multaq^® first quarter gross sales grew 13.9% to €87 million, reflecting sturdy U.S. gross sales development.

Gross sales of Rezurock^®, a lately FDA-approved, first-in-class therapy for continual graft-versus-host illness (cGVHD) for grownup and pediatric sufferers 12 years and older who’ve failed at the least two prior traces of systemic remedy, have been consolidated as of November 9, 2021 (by way of the Kadmon acquisition) and generated €41 million within the first quarter. Rezurock^® efficiency displays the quickly increasing pool of prescribing establishments in addition to pent-up demand from cGVHD sufferers who’ve already failed a number of systemic therapies.

Praluent^® first-quarter gross sales have been €69 million, up 21.4% pushed by Europe efficiency. In Remainder of the World area, gross sales have been up 6.7%. In China, Praluent^® was included within the NDRL record initially of 2022.

First-quarter Soliqua^® gross sales elevated 15.9% to €53 million pushed by the Remainder of World area (up 54.5%) supported by new launches and Solimix outcomes.

Non-core property

Within the first quarter, non-core property gross sales decreased 4.2% to €1,983 million reflecting portfolio streamlining (-1.4ppt), decrease Lantus^® gross sales in addition to the impression of VBP wave 5 in China on Eloxatin^® and Taxotere^® gross sales.

Lantus^® gross sales have been €671 million, down 1.5% within the first quarter, because of decrease gross sales in Europe, reflecting biosimilar competitors and steady Toujeo^® switches.

First-quarter Aprovel^®/Avapro^® gross sales have been up 17.8% to €125 million, because of some provide enchancment and in contrast with a low base within the first quarter of 2021.
  

Prescribed drugs enterprise working earnings

Within the first quarter, enterprise working earnings (BOI) of Prescribed drugs elevated 12.6% to €2,831 million (up 8.8% at CER). The ratio of BOI to web gross sales elevated by 0.3 share level to 38.6% (38.8% at CER), reflecting an enchancment of the gross margin ratio.

Vaccines

First-quarter Vaccines gross sales elevated 6.8% to €1,020 million pushed by double-digit development of Polio/Pertussis/Hib vaccines gross sales and partial restoration of Journey vaccines.

Within the first quarter, Polio/Pertussis/Hib (PPH) vaccines gross sales elevated 10.3% to €613 million. Within the Remainder of the World area, PPH gross sales grew 23.1% pushed by a powerful efficiency of Pentaxim^® in China in comparison with a low base final 12 months and favorable timing of polio tender supply. Within the U.S., PPH gross sales have been impacted by stock fluctuation and progressive ramp up of Vaxelis^® gross sales. As a reminder, Vaxelis^® in-market gross sales aren’t consolidated and the earnings are shared equally between Sanofi and Merck.

First-quarter Meningitis gross sales decreased 16.4% to €112 million, because of decrease gross sales in Latin America reflecting value competitors in public tenders.

Booster vaccines gross sales elevated 4.0% within the first quarter to €109 million, pushed by the Remainder of the World area.

First-quarter Journey and endemic vaccines gross sales elevated 61.0% to €98 million, reflecting a partial restoration of Journey vaccines in Europe and the U.S. in addition to greater endemic vaccines gross sales within the Remainder of the World area.

Influenza vaccines gross sales decreased 18.2% within the first quarter, reaching €66 million because of an distinctive excessive demand within the first quarter of 2021.

Vaccines enterprise working earnings

Within the first quarter, enterprise working earnings (BOI) decreased 20.2% (down 24.8% at CER) to €296 million in comparison with the identical interval of final 12 months. This displays greater R&D bills associated to Translate Bio and the mRNA heart of excellence and the cost from Daiichi Sankyo recorded within the first quarter of 2021. BOI to web gross sales ratio was 29.0% (versus 40.5% within the first quarter of 2021, 27.5% excluding the cost from Daiichi Sankyo).

Client Healthcare

Within the first quarter, Client Healthcare (CHC) gross sales elevated 17.0% to €1,328 million sustained by development in Europe and the Remainder of the World area. This efficiency was primarily pushed by the sturdy demand for Cough & Chilly merchandise, in addition to the efficiency of Ache Care and Digestive Wellness classes. This world efficiency features a constructive value impact of three%. The divestments of non-core merchandise had an impression of -0.6 ppt of development within the first quarter.

Within the U.S., first-quarter CHC gross sales elevated 2.1% to €310 million pushed by double-digit development of Allergy class partially offset by decrease gross sales of Private care and non-core property primarily because of provide constraints.

In Europe, first-quarter CHC gross sales elevated 21.0% to €406 million primarily reflecting sturdy development of the Cough & Chilly and Ache Care classes.

In Remainder of World, first-quarter CHC gross sales elevated 22.8% to €612 million, supported by development in all classes.

CHC enterprise working earnings

Within the first quarter, enterprise working earnings (BOI) of CHC elevated 51.3% (up 48.0% at CER) to €596 million. The ratio of BOI to web gross sales elevated 9.5 share level to 44.9% versus the prior 12 months, reflecting sturdy prime line development in addition to a capital achieve associated to divestments of non-strategic property.

Firm gross sales by geographic area

First-quarter gross sales within the U.S. elevated +12.1% to €3,484 million supported by the sturdy efficiency of Dupixent^®.

In Europe gross sales elevated +6.7% within the first quarter to €2,392 million primarily pushed by Dupixent^® efficiency in addition to sturdy CHC development.

In Remainder of World gross sales elevated +7.0% to €3,798 million within the first quarter, reflecting the efficiency of Dupixent^®, CHC and Vaccines which largely offset decrease gross sales of Normal Medicines. Gross sales in China elevated 13.4% to €901 million primarily on account of the expansion of Dupixent^®, Vaccines and CHC. In Japan, first-quarter gross sales elevated 1.6% to €433 million pushed by Dupixent^® and Sarclisa^® which greater than offset decrease gross sales of Normal Medicines. In Russia, because of sturdy cough, chilly and flu associated gross sales, greater vaccines gross sales and unprecedented stockpiling at pharmacy and affected person degree gross sales elevated 34.4% within the first quarter. In March, Sanofi has determined to cease any new spending not associated to the availability of its important and life-changing medicines and vaccines in Russia. This contains all promoting and promotional spending.

R&D replace on the finish of the primary quarter 2022

Regulatory replace

• The European Medicines Company’s Committee for Medicinal Merchandise for Human Use (CHMP) has adopted a constructive opinion recommending to increase the approval of Dupixent^® (dupilumab) within the European Union to incorporate add-on upkeep therapy for youngsters aged 6 to 11 years with extreme bronchial asthma with kind 2 irritation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who’re inadequately managed on two upkeep therapies.
• The U.S. Meals and Drug Administration (FDA) has accepted for Precedence Evaluate the supplemental Biologics License Software (sBLA) for Dupixent^® as an add-on upkeep therapy for youngsters aged 6 months to five years with moderate-to-severe atopic dermatitis whose illness will not be adequately managed with topical prescription therapies or when these therapies aren’t advisable. The goal motion date for the FDA resolution on this investigational use is June 9, 2022. Dupixent^® stays the one biologic drugs permitted for sufferers 6 years of age and older on this indication.
• The FDA has accepted for Precedence Evaluate the supplemental Biologics License Software (sBLA) for Dupixent^® 300 mg weekly to deal with adults and adolescents aged 12 years and older with eosinophilic esophagitis (EoE), a continual and progressive kind 2 inflammatory illness that damages the esophagus and the flexibility to swallow.
• The FDA has permitted Enjaymo™ (sutimlimab-jome), the primary and solely permitted therapy to lower the necessity for purple blood cell transfusion because of hemolysis in adults with chilly agglutinin illness (CAD). CAD is a continual and uncommon blood dysfunction that impacts the lives of an estimated 5,000 folks within the U.S. Sanofi estimates round 3,200 sufferers to be drug-treated per 12 months and that Enjaymo may attain a market share of round 25% within the years to return.
• The Japanese Ministry of Well being, Labor and Welfare (MHLW) has granted advertising authorization for Xenpozyme^® (olipudase alfa) for the therapy of grownup and pediatric sufferers with non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD). Xenpozyme^® is at the moment the one permitted therapy for ASMD and represents Sanofi’s first remedy to be permitted underneath the SAKIGAKE or pioneer designation, which is the Japanese authorities’s regulatory fast-track pathway to advertise analysis and improvement of revolutionary new medical merchandise addressing pressing unmet medical wants.
• The EMA has accepted the Advertising Authorization Software (MAA) for nirsevimab underneath an accelerated evaluation process. Nirsevimab, the primary investigational long-acting antibody designed to guard all infants towards medically attended decrease respiratory tract infections (LRTI) for the respiratory syncytial virus (RSV) season, is being developed by Sanofi and AstraZeneca. The New England Journal of Medication (NEJM) revealed detailed Section 3 outcomes of the MELODY trial. On this research, with wholesome infants born at time period or late preterm getting into their first RSV season, the first endpoint was met, lowering the incidence of medically attended LRTI, corresponding to bronchiolitis or pneumonia, attributable to RSV by 74.5% in comparison with placebo.
• The EMA has began to guage the applying for the conditional advertising authorization of the Sanofi-GSK first-generation recombinant COVID-19 vaccine as a major vaccine and a booster designed to spice up all at the moment permitted COVID-19 vaccine platforms. Closing evaluation of the VAT02 COVID-19 booster trial confirms common potential to spice up neutralizing antibodies 18- to 30-fold throughout vaccine platforms. The VAT08 major collection trial, with two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated 100% efficacy towards extreme COVID-19 illness and hospitalizations, 75% efficacy towards average or extreme COVID-19 illness, and 57.9% efficacy towards any symptomatic COVID-19 illness, in keeping with anticipated vaccine effectiveness in as we speak’s setting dominated by variants of concern. When the Sanofi-GSK vaccine was used as a two-dose major collection adopted by a booster dose, neutralizing antibodies elevated 84- to 153-fold in comparison with pre-boost ranges.
• Sanofi and Regeneron introduced the voluntary withdrawal of the sBLA for Libtayo^® (cemiplimab-rwlc) as a second-line therapy for sufferers with superior cervical most cancers. The choice was made after the businesses and the FDA weren’t capable of align on sure post-marketing research. Discussions with regulatory authorities exterior of the U.S. are ongoing.

Portfolio replace

Section 3:

• Sanofi and Sobi introduced constructive topline outcomes from the pivotal XTEND-1 research evaluating the protection, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001), a once-weekly recombinant issue VIII remedy, in beforehand handled sufferers ≥12 years of age with extreme hemophilia A. The research met each major and secondary endpoints, displaying a clinically significant prevention of bleeds in folks with extreme hemophilia A over a interval of 52 weeks, with a median annualized bleeding fee (ABR) of 0 and a imply ABR of 0.71, and a superiority to prior prophylactic issue VIII alternative remedy based mostly on intra-patient comparability. Sanofi plans to submit the info within the U.S. mid-2022. Submission within the EU will observe the provision of knowledge from the continued XTEND-Children pediatric research, anticipated in 2023.
• A second trial (PRIME) evaluating Dupixent^® in adults with uncontrolled prurigo nodularis (PN), met its major and key secondary endpoints, displaying it considerably lowered itch and pores and skin lesions in comparison with placebo at 24 weeks on this investigational setting. The information verify the constructive outcomes that have been beforehand reported from the Section 3 PRIME2 trial.
• The LIBERTY-CPUO-CHIC research evaluating the efficacy and security of subcutaneous Dupixent^® for the therapy of grownup members with continual pruritus of unknown origin (CPUO) has initiated, and enrolled its first participant.
• The CUPID Examine B evaluating Dupixent^® in sufferers with continual spontaneous urticaria (CSU), who have been refractory to omalizumab, stopped because of futility based mostly on a pre-specified interim evaluation. Though constructive numerical traits in lowering itch and hives have been noticed, the outcomes from the interim evaluation didn’t show statistical significance for the first endpoints. The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated direct-to-Section 3 technique. The beforehand reported Section 3 trial (Examine A), which evaluated a special group of sufferers who have been biologic-naïve, met its major and all key secondary endpoints at 24 weeks displaying that including Dupixent to standard-of-care antihistamines considerably lowered itch and hives in comparison with antihistamines alone. Sanofi and Regeneron stay dedicated to advancing Dupixent for sufferers with CSU uncontrolled on antihistamines, subsequent steps are being evaluated together with discussions with regulatory authorities.
• The scientific trial evaluating the efficacy and security of amcenestrant in contrast with tamoxifen in sufferers with HR+ early breast most cancers who’ve discontinued adjuvant aromatase inhibitor (AI) remedy because of therapy associated toxicity (AMEERA-6), enrolled its first participant.

Section 2:

• Three research assessing rilzabrutinib have initiated, and enrolled their first members: a randomized, double-blind, placebo-controlled research in adults with moderate-to-severe bronchial asthma, a randomized, double-blind, placebo-controlled research in CSU, and an open-label research in adults with Heat Autoimmune Hemolytic Anemia (wAIHA).
• The non-randomized and open-label research assessing the scientific advantage of SAR444245 mixed with different anticancer therapies for the therapy of adults with superior or metastatic gastrointestinal most cancers was initiated, and was administered to the primary participant.
• The pivotal AMEERA-3 scientific trial evaluating amcenestrant, an investigational optimized oral selective estrogen receptor degrader (SERD), as monotherapy in comparison with endocrine therapy of doctor’s alternative in sufferers with regionally superior or metastatic ER+/HER2- breast most cancers who progressed on or after hormonal therapies, didn’t meet its major endpoint of bettering progression-free survival as assessed by an impartial central overview.

Section 1:

• The research assessing the protection and efficacy of 4 investigational HSV 2 vaccines in adults with recurrent genital herpes attributable to HSV 2 (HSV15) has been discontinued.

Given the conflict in Ukraine and the struggling of the Ukrainian folks, Sanofi has tailored its scientific trial implementation within the area. The corporate determined to halt any new recruitment of sufferers for ongoing scientific trials in Russia and Belarus, although it would proceed to deal with sufferers already enrolled. In Ukraine, Sanofi is doing the whole lot it could actually to assist and provide sufferers at the moment enrolled in Sanofi-sponsored scientific trials, together with transferring them inside Ukraine or into neighboring nations. In anticipation of potential lack of information, the corporate is at the moment activating new scientific websites and increasing affected person enrollment in geographies not impacted by the conflict. This will likely result in the deliberate major completion dates of its pivotal trials in MS and COPD to shift, beforehand communicated submission timelines stay unchanged.

Acquisitions and main collaborations

• Sanofi and Blackstone introduced a strategic, risk-sharing collaboration underneath which funds managed by Blackstone Life Sciences will contribute as much as €300 million to speed up the worldwide pivotal research and the scientific improvement program for the subcutaneous formulation and supply of the anti-CD38 antibody Sarclisa^®, to deal with sufferers with a number of myeloma (MM), anticipating to start within the second half of 2022.
• Sanofi introduced the analysis collaboration and license settlement to develop as much as 15 novel small molecule candidates throughout oncology and immunology with Exscientia, leveraging their end-to-end AI-driven platform using precise affected person samples. The businesses have been working collectively since 2016 and in 2019, Sanofi in-licensed Exscientia’s novel bispecific small molecule candidate able to focusing on two distinct targets in irritation and immunology.
• Sanofi introduced the completion of the acquisition of Amunix Prescribed drugs, Inc, including a promising pipeline of T-cell engagers and cytokine therapies. The acquisition additionally gives entry to their Professional-XTEN, XPAT, and XPAC expertise to ship subsequent technology conditionally activated biologics. The expertise platform is very complementary to Sanofi’s present R&D platforms and helps Sanofi’s efforts to speed up and develop its contributions to revolutionary medicines for oncology sufferers, with roughly 20 molecules at the moment in improvement.
• Sanofi and Seagen introduced an unique collaboration settlement to design, develop, and commercialize antibody-drug conjugates (ADCs) for as much as three most cancers targets. The collaboration will make the most of each Sanofi’s proprietary monoclonal antibody expertise and Seagen’s proprietary ADC expertise.
• Sanofi and IGM Biosciences introduced the signing of an unique worldwide collaboration settlement to create, develop, manufacture, and commercialize IgM antibody agonists towards three oncology targets and three immunology/irritation targets.

An replace of the R&D pipeline at as of March 31, 2022, is out there on Sanofi’s web site:

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

  
Progress on implementation of the Company Social Accountability technique

Sanofi continues its progress to enhance entry to medicines

Sustainability-linked bond tied to Sanofi’s Entry commitments

Sanofi is dedicated to combine sustainability inside its Play to Win enterprise technique, in addition to inside its funding and financing technique. Greater than a 12 months after issuing its first sustainability-linked credit score revolving amenities, Sanofi efficiently priced an inaugural sustainability-linked bond listed on entry to medicines. A nominal quantity of EUR 650 million of notes, tied to Sanofi’s dedication to enhance entry to important medicines in low- and lower-middle-income nations by way of its world well being non-profit unit. This transaction demonstrates Sanofi’s dedication to society, to make sure entry to healthcare for the world’s weak folks.

Entry and Pricing Rules at Sanofi

Sanofi has a protracted historical past of working with healthcare programs to make its therapies accessible and reasonably priced to sufferers in want. Sanofi understands and shares considerations in regards to the affordability of medicines for sufferers and Sanofi encourages nations to enhance worth in healthcare spending. Nevertheless, the Firm firmly believes that the pharmaceutical trade is simply one of many many stakeholders within the healthcare system that may and will contribute to this purpose. Given the rising considerations over rising healthcare prices, Sanofi has developed an method to pricing that displays its dedication to broadly increasing affected person entry to medicines and vaccines whereas sustaining sustainable funding in Analysis & Growth. The Entry & Pricing Rules it places forth are based on 2 pillars:

• Clear rationale for pricing and entry on the time of launch of a brand new drugs or vaccine
• Inclusion of affordability standards into pricing concerns for brand new launches

When the Firm units the worth of a brand new drugs, it holds itself to a rigorous and structured course of that features session with exterior stakeholders and considers the next elements:

• Holistic evaluation of worth (scientific, social and wellbeing and financial worth)
• Availability or anticipation of comparable therapies on the time of launch
• Means of market to afford new medicines
• Distinctive elements particular to the drugs or vaccine on the time of launch

Sanofi discloses extra data on its world entry and pricing rules on its world web site and particularly on its U.S. pricing coverage on the Sanofi U.S. web site.

Constructing partnerships to assist Sanofi’s pediatric most cancers dedication

For the childhood most cancers flagship program, Sanofi goals to work along with companions, throughout sectors, to advance data in pediatric research.

Within the analysis discipline, Sanofi is now one of many companions of the Pediatric Pre-clinical Proof of Idea Platform (ITCC-P4) that goals to allow cutting-edge upfront preclinical testing of novel molecularly focused compounds. Sanofi has lately engaged in a Pediatric Oncology Related Goal collaboration led by the Basis for the Nationwide Institutes of Well being (FNIH) to overview and prioritize targets.

For the event of revolutionary scientific trials, Sanofi is proud to be working intently with consultants at MD Anderson Most cancers Middle, Institut Gustave Roussy, Kids’s Hospital of Philadelphia, Dana-Farber Most cancers Institute, Memorial Sloan Kettering Most cancers Middle. All of those efforts are centered on affected person wants as highlighted by Sanofi’s assist to childhood most cancers advocacy teams together with Coalition In opposition to Childhood Most cancers (CAC2) and Think about for Margo.

ESG dashboard

In 2020, as Sanofi renewed its CSR ambitions, the Firm reviewed and up to date its portfolio of initiatives. Numbers proven under spotlight the continued progress within the implementation of Sanofi’s CSR technique.

Reasonably priced entry

Sanofi International Well being, a non-profit unit shaped throughout the firm in April 2021, goals to supply 30 of Sanofi’s medicines throughout a variety of therapeutic areas to sufferers in 40 of the bottom earnings nations. Past the merchandise supplied, Sanofi International Well being will even give attention to built-in applications that guarantee optimum care administration over time for sufferers.

Sanofi can also be dedicated to serving to 1,000 sufferers residing with uncommon ailments who haven’t any entry to therapies and can donate 100,000 vials of medication for his or her therapies every year. This continues Sanofi’s 30-year dedication to sufferers affected by uncommon ailments, corresponding to Fabry, Gaucher or Pompe ailments, for which entry to therapy is commonly restricted.

The third initiative on entry is to develop a worldwide entry plan for all new merchandise, making them accessible in chosen related markets inside two years of launch.

Innovating for weak communities

Sanofi continues its efforts to struggle polio and sleeping illness, two of its legacy applications that handle world well being points.

Sanofi has been concerned within the struggle towards polio from the start and continues to play a vital function within the supply of polio vaccines. The Firm has additionally dedicated to collaborate with the WHO to remove sleeping illness by 2030.

A part of Sanofi’s R&D ambition is to develop revolutionary medicines to remove most cancers deaths in youngsters.

Defending the planet

To contribute to higher useful resource conservation, Sanofi plans to take away all plastic blister packs for its vaccines by 2027. As well as, the corporate is dedicated to eco-designing all its new merchandise by 2025. To scale back its greenhouse fuel emissions by 55% by 2030, all Sanofi websites will use 100% electrical energy from renewable sources and the Firm has set a goal of a carbon-neutral for its automobile fleet, each by 2030.

Constructing an inclusive office

As a worldwide firm, Sanofi is dedicated to making sure that its leaders replicate the communities and sufferers it serves. The Firm is dedicated to proceed fostering a company the place all staff have equal alternatives to succeed in positions of duty throughout the firm. Sanofi’s ambition is to have 40% of ladies in prime govt roles and 50% of ladies in senior management roles by 2025. Sanofi is continuous its social and financial engagement within the communities it operates in. Lastly, Sanofi is embedding its dedication to society in its leaders’ profession improvement paths to strengthen the social impression of their choices.

ESG scores

Sanofi was acknowledged as one of the vital sustainability-committed corporations in an ESG Analysis (Surroundings, Social, Governance) carried out by Customary & Poor’s International Scores (S&P).

The ESG Analysis awarded Sanofi a rating of 86 out of 100 factors, one of many highest scores throughout all sectors globally. Sanofi’s ESG profile was awarded 80 factors for its stable fundamentals, accomplished with an extra sturdy preparedness opinion of 6 factors awarded for its wonderful consciousness of dangers and alternatives and its capability to anticipate and adapt to quite a lot of long-term believable disruptions.

Sanofi’s Social Profile was ranked as ‘main’ within the class of communities highlighting the latest 2021 creation of its world well being unit which goals to supply 30 of Sanofi’s medicines throughout a variety of therapeutic areas to sufferers in 40 of the bottom earnings nations. The report additionally famous Sanofi’s dedication to eliminating infectious illness corresponding to polio, sleeping illness and malaria.

Sanofi was notably distinguished for its dedication to entry to medicines, notably in weak communities. The research, which acknowledged ‘the growing challenges and inequalities in healthcare throughout all geographies’, recognized the creation of a non-profit unit devoted to offering poorest nations with entry to important medicines as one in every of Sanofi’s main differentiators.

The continual implementation of Sanofi’s social impression technique has led in latest months to a variety of constructive updates of the corporate’s rank or grade in many of the ESG rankings.

Covid Replace

Sanofi and GSK utilized for regulatory authorization of their first-generation COVID-19 vaccine in Europe with information supporting its use as a common booster, designed to spice up all at the moment permitted COVID-19 vaccine platforms. As well as, the businesses are growing a next-generation booster vaccine designed to supply broad safety towards all variants of concern, from the unique pressure to Omicron BA.2. The information (VAT02 Cohort 2) is predicted to be communicated in Q2 2022.
  
First-quarter 2022 monetary outcomes

Enterprise Internet Revenue²

Within the first quarter of 2022, Sanofi generated web gross sales of €9,674 million, a rise of 12.6% (up 8.6% at CER).

First-quarter different revenues elevated 28.5% (up 23.7% at CER) to €379 million, together with VaxServe gross sales contribution of non-Sanofi merchandise of €286 million (up 16.7 % at CER).

First-quarter Gross Revenue elevated 15.7% (up 11.1% at CER) to €7,175 million. The gross margin ratio elevated 2.0 share factors to 74.2% versus the primary quarter of 2021, reflecting sturdy enchancment of the Prescribed drugs gross margin ratio (which elevated from 75.2% to 77.9%) pushed by favorable impression of rising weight of Specialty Care, effectivity good points in Industrial Affairs and decrease royalty bills. The Vaccines gross margin ratio barely decreased to 61.6% from 62.0%. CHC gross margin ratio was 67.3%, down 0.7 share level.

Analysis and Growth (R&D) bills elevated 17.5% (up 14.0% at CER) to €1,489 million within the first quarter, reflecting enhance in precedence property improvement in addition to latest acquisitions.

First-quarter promoting basic and administrative bills (SG&A) elevated 8.4% to €2,379 million. At CER, SG&A bills have been up 4.3%, reflecting elevated industrial investments in Specialty Care development drivers which have been partially offset by continued streamlining initiatives. Within the first quarter, the ratio of SG&A to gross sales decreased 0.9 share level to 24.6% in comparison with the prior 12 months.

First-quarter working bills have been €3,868 million, a rise of 11.8% and seven.8% at CER.

First-quarter different present working earnings web of bills was -€265 million versus -€101 million within the first quarter of 2021. Different present working earnings web of bills included an expense of €477 million (versus an expense of €279 million within the first quarter of 2021) comparable to the share of revenue to Regeneron of the monoclonal antibodies Alliance, reimbursement of improvement prices by Regeneron and the reimbursement of commercialization-related bills incurred by Regeneron. Within the first quarter, this line additionally included €232 million of web capital good points associated to Normal Medicines and CHC portfolio streamlining in comparison with €56million in the identical interval of 2021.

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

First-quarter enterprise working earnings² (BOI) elevated 16.2% to €3,065 million. At CER, BOI elevated 12.2%. The ratio of BOI to web gross sales elevated 1.0 share level to 31.7% primarily reflecting gross margin ratio enchancment.

Internet monetary bills have been €78 million versus €84 million in the identical interval of 2021.

First-quarter efficient tax fee was 19.0% versus 21.0% within the prior 12 months. Sanofi expects its efficient tax fee to be round 19% in 2022.

First-quarter enterprise web earnings² elevated 20.2% to €2,424 million and elevated 16.0% at CER. The ratio of enterprise web earnings to web gross sales elevated 1.6 share level to 25.1% versus the primary quarter of 2021.

Within the first quarter of 2022, enterprise earnings per share² (EPS) was €1.94, up 20.5% on a reported foundation (up 16.1% at CER). The common variety of shares excellent was 1,249.2 million versus 1,249.3 million in first quarter 2021.

   
Reconciliation of IFRS web earnings reported to enterprise web earnings (see Appendix 4)

Within the first quarter of 2022, the IFRS web earnings was €2,009 million. The primary objects excluded from the enterprise web earnings have been:

• An amortization cost of €449 million associated to honest worth remeasurement on intangible property of acquired corporations (primarily Genzyme: €145 million, Bioverativ: €88 million, Boehringer Ingelheim CHC enterprise: €48 million, Ablynx: €42 million and Kadmon: €37 million) and to acquired intangible property (licenses/merchandise: €24 million). This stuff haven’t any money impression on the Firm.
• An impairment of intangible property of €5 million.
• Restructuring prices and related objects of €175 million associated to streamlining initiatives.
• A €232 million tax impact arising from the objects listed above, primarily comprising €96 million of deferred taxes generated by amortization and impairments of intangible property and €46 million related to restructuring prices and related objects (see Appendix 4).

Capital Allocation

Within the first quarter of 2022, free money stream earlier than restructuring, acquisitions and disposals decreased by 15.5% to €1,998 million, after web modifications in working capital (-€468 million) and capital expenditures (-€356 million). After acquisitions (-€277 million), proceeds from disposals³ (+€347 million) and funds associated to restructuring and related objects (-€361 million), free money stream⁴ decreased by 11.3% to €1,707 million. After the acquisition of Amunix (-€803 million), web debt decreased from €9,983 million at December 31, 2021 to €9,432 million at March 31, 2022 (quantity web of €8,728 million money and money equivalents).

Ahead-Wanting Statements

This press launch accommodates forward-looking statements as outlined within the Personal Securities Litigation Reform Act of 1995, as amended. Ahead-looking statements are statements that aren’t historic details. These statements embrace projections and estimates and their underlying assumptions, statements concerning plans, targets, intentions and expectations with respect to future monetary outcomes, occasions, operations, companies, product improvement and potential, and statements concerning future efficiency. Ahead-looking statements are typically recognized by the phrases “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and related expressions. Though Sanofi’s administration believes that the expectations mirrored in such forward-looking statements are cheap, traders are cautioned that forward-looking data and statements are topic to varied dangers and uncertainties, a lot of that are troublesome to foretell and customarily past the management of Sanofi, that would trigger precise outcomes and developments to vary materially from these expressed in, or implied or projected by, the forward-looking data and statements. These dangers and uncertainties embrace amongst different issues, the uncertainties inherent in analysis and improvement, future scientific information and evaluation, together with submit advertising, choices by regulatory authorities, such because the FDA or the EMA, concerning whether or not and when to approve any drug, system or organic utility that could be filed for any such product candidates in addition to their choices concerning labelling and different issues that would have an effect on the provision or industrial potential of such product candidates, the truth that product candidates if permitted is probably not commercially profitable, the long run approval and industrial success of therapeutic options, Sanofi’s potential to learn from exterior development alternatives, to finish associated transactions and/or acquire regulatory clearances, dangers related to mental property and any associated pending or future litigation and the final word end result of such litigation, traits in change charges and prevailing rates of interest, unstable financial and market circumstances, value containment initiatives and subsequent modifications thereto, and the impression that COVID-19 can have on us, our clients, suppliers, distributors, and different enterprise companions, and the monetary situation of any one in every of them, in addition to on our staff and on the worldwide financial system as a complete. Any materials impact of COVID-19 on any of the foregoing may additionally adversely impression us. This example is altering quickly and extra impacts could come up of which we aren’t at the moment conscious and will exacerbate different beforehand recognized dangers. The dangers and uncertainties additionally embrace the uncertainties mentioned or recognized within the public filings with the SEC and the AMF made by Sanofi, together with these listed underneath “Danger Components” and “Cautionary Assertion Relating to Ahead-Wanting Statements” in Sanofi’s annual report on Kind 20-F for the 12 months ended December 31, 2021. Aside from as required by relevant legislation, Sanofi doesn’t undertake any obligation to replace or revise any forward-looking data or statements.

Appendices

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | [email protected]
Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist[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]

Appendix 1: 2022 first-quarter web gross sales by GBU, franchise, geographic area and product

Appendix 2: Enterprise web earnings assertion

* Internet of tax.        
** Decided on the idea of Enterprise earnings earlier than tax, associates, and non-controlling pursuits.
*** Primarily based on a mean variety of shares excellent of 1,249.2 million within the first quarter of 2022 and 1,249.3 million within the first quarter of 2021.
                                                                                                            

⁽¹⁾  Different contains the price of world assist features (Finance, Human Sources, Info Resolution & Applied sciences, Sanofi Enterprise Providers, and so forth…).
⁽²⁾  Contains the impacts of the IFRIC remaining agenda resolution of April 2021 on the attribution of advantages to durations of service.

Appendix 3: Consolidated earnings statements

(1)   Contains the impacts of the IFRIC remaining agenda resolution of April 2021 on the attribution of advantages to durations of service

Appendix 4: Reconciliation of Internet earnings attributable to fairness holders of Sanofi to Enterprise web earnings

(1)    Contains the impacts of the IFRIC remaining agenda resolution of April 2021 on the attribution of advantages to durations of service.

(2)   Of which associated to amortization expense generated by the remeasurement of intangible property as a part of enterprise mixtures: €425 million within the first quarter of 2022 and €369 million within the first quarter of 2021.

(3)   Primarily based on a mean variety of shares excellent of 1,249.2 million within the first quarter of 2022 and 1,249.3 million within the first quarter of 2021.

Appendix 5: Change in web debt

(1)   Contains the impacts of the IFRIC remaining agenda resolution of April 2021 on the attribution of advantages to durations of service.

(2)   Free money stream contains investments and divestments not exceeding a cap of €500 million per transaction (inclusive of all funds associated to the transaction).

(3)   Contains transactions which are above a cap of €500 million per transaction (inclusive of all funds associated to the transaction).

  
Appendix 6: Foreign money sensitivity

2022 enterprise EPS forex sensitivity

Foreign money publicity on Q1 2022 gross sales

Foreign money common charges

Appendix 7: Definitions of non-GAAP monetary indicators

Firm gross sales at fixed change charges (CER)

Once we confer with modifications in our web gross sales “at fixed change charges” (CER), which means we exclude the impact of modifications in change charges.

We remove the impact of change charges by recalculating web gross sales for the related interval on the change charges used for the earlier interval.

Reconciliation of web gross sales to Firm gross sales at fixed change charges for the primary quarter 2022

Enterprise web earnings

Sanofi publishes a key non-GAAP indicator. Enterprise web earnings is outlined as web earnings attributable to fairness holders of Sanofi excluding:

• amortization of intangible property,
• impairment of intangible property,
• honest worth remeasurement of contingent consideration associated to enterprise mixtures or to disposals,
• different impacts related to acquisitions (together with impacts of acquisitions on associates and joint ventures),
• restructuring prices and related objects⁽¹⁾,
• different good points and losses (together with good points and losses on disposals of non-current property⁽¹⁾),
• prices or provisions related to litigation⁽¹⁾,
• achieve on Regeneron funding on account of the transaction accomplished on Could 29, 2020 (the quantity doesn’t embrace the achieve associated to the remeasurement at honest worth at this date of the 400,000 retained shares),
• tax results associated to the objects listed above in addition to results of main tax disputes,
• impact of fairness technique accounting for Regeneron funding (excluded from Enterprise web earnings) as a consequence of the sale of the complete fairness funding in Regeneron (apart from 400,000 shares retained by Sanofi) on Could twenty ninth 2020),
• web earnings attributable to non-controlling pursuits associated to the objects listed above.

(1) Reported within the line objects Restructuring prices and related objects and Beneficial properties and losses on disposals, and litigation, that are outlined in Notes B.19. and B.20. to our consolidated monetary statements.

Free money stream

Free money stream is a non-GAAP monetary indicator which is reviewed by our administration, and which we imagine gives helpful data to measure the web money generated from the Firm’s operations that’s accessible for strategic investments¹ (web of divestments¹), for debt reimbursement, and for capital return to shareholders. Free Money Circulation is set from the Enterprise Internet Revenue adjusted for depreciation, amortization and impairment, share of revenue/loss in associates and joint ventures web of dividends acquired, good points & losses on disposals, web change in provisions together with pensions and different post-employment advantages, deferred taxes, share-based expense and different non-cash objects. It includes web modifications in working capital, capital expenditures and different asset acquisitions² web of disposal proceeds², and funds associated to restructuring and related objects. Free money stream will not be outlined by IFRS and it’s not a substitute measure for the IFRS mixture web money flows in working actions.

¹ Quantity of the transaction above a cap of €500 million per transaction (inclusive of all funds associated to the transaction).
² Not exceeding a cap of €500 million per transaction (inclusive of all funds associated to the transaction).

1 See Appendix 7 for definitions of economic indicators.
2 definition in Appendix 7
3 Not exceeding €500 million per transaction (inlusive of all funds associated to the transaction).
4 Non-GAAP monetary measure (definition in Appendix 7).