And just 2 quick ones. Firstly, just on the oral TNF again. Obviously, one of the indications where we are seeing OTNF still be used and actually not facing the same competition is HS, where I think you've also got some other programs looking at as well. I'm curious, I guess, why necessarily the focus on psoriasis, which is a pretty competitive market and I guess not some other potential statements as there are where perhaps less competition about the more amenable there for you to be an early entrant. Thom ...

Financial Performance - FDA approved ALTUVIIIO™, a new class of factor VIII therapy for hemophilia A, leading to a €2,154 million impairment reversal impacting 2022 IFRS net income[1][2] - Adjusted IFRS net income for 2022 is €8,371 million, a 34.5% increase from the previous figure of €6,720 million[2][4] - Earnings per share (IFRS EPS) for 2022 increased to €6.69, up 34.6% from €5.37[2][4] - IFRS net sales for Q4 2022 were €10,725 million, reflecting a 7.3% increase, and total 2022 net sales reached €42,997 million, a 13.9% increase[4] - Business operating income for 2022 was €13,040 million, a 21.7% increase year-over-year[4] - Free cash flow for 2022 amounted to €8,483 million, representing a 4.8% increase[4] - Business net income for 2022 remained unchanged at €10,341 million, with a 25.9% increase year-over-year[3][4] - The total equity for the company as of December 31, 2022, is €75,152 million, up from €73,512 million[2][4] Strategic Focus - The company continues to focus on innovative healthcare solutions and expanding its market presence globally[6] - Sanofi's commitment to sustainability and social responsibility remains central to its business strategy[6]

Sales and Market Presence - In 2022, 42.5% of net sales were generated in the United States, 23.3% in Europe, and 34.2% in the Rest of the World, with 7.3% in China and 3.8% in Japan[132]. - Sanofi ranks twelfth in the US pharmaceutical market with a market share of 3.6%[297]. - In France, Sanofi is the sixth largest pharmaceutical company with a market share of 4.7%[297]. - Sanofi's market share in Germany is 3.3%, ranking eighth among pharmaceutical companies[297]. - The company ranks eighteenth in Japan with a market share of 1.8% and twelfth in China with a market share of 1.5%[297]. - Sanofi operates in approximately 90 countries, with products available in over 180 countries[293]. - The company is the ninth largest pharmaceutical company globally by sales[293]. Product Development and Innovation - Sanofi's peak sales ambition for Dupixent is raised to more than €13 billion, driven by its unique mechanism of action targeting type 2 inflammation[153]. - The Vaccines business is expected to deliver mid-to-high single-digit net sales growth, with plans to double sales by the end of the decade based on 2018 sales[153]. - Six new vaccine candidates using mRNA technologies are planned to enter the clinic by 2025, targeting diseases with high unmet needs[153]. - Sanofi acquired Amunix Pharmaceuticals in February 2022, gaining access to innovative Pro-XTEN technology and a promising pipeline of immunotherapies[149]. - The company aims to focus investments on six potentially transformative therapies across oncology, immunology, hematology, neurology, and vaccines[153]. - Fitusiran is in development for hemophilia A and B, potentially becoming a first-in-class therapeutic option[157]. - ALTUVIIIO received FDA approval on February 22, 2023, for once-weekly prophylactic treatment in hemophilia A, maintaining factor concentrations at normal levels[157]. - Dupixent has shown significant clinical benefits across over 60 trials, targeting type 2 inflammation in various chronic diseases[163]. - Dupixent was approved for eosinophilic esophagitis (EoE) in patients aged 12 years and older on May 20, 2022, becoming the first specific treatment for EoE in the U.S.[169]. - Dupixent is being evaluated for additional indications, including chronic obstructive pulmonary disease (COPD) and chronic spontaneous urticaria (CSU)[174]. - Sanofi completed the acquisition of Amunix Pharmaceuticals, enhancing its pipeline with T-cell engagers and cytokine therapies[157]. - The Vaccines R&D portfolio includes 11 projects in advanced development, including mRNA vaccines for RSV and influenza[279]. - MenQuadfi, a meningococcal quadrivalent conjugate vaccine, is licensed in the US and Europe, with ongoing Phase III trials for infants[284]. Strategic Collaborations and Partnerships - Collaborations are essential for Sanofi, with many products relying on third-party rights or technologies[143]. - The company has entered into multiple strategic collaborations to advance its drug development pipeline across oncology and immunology[157]. - Sanofi is collaborating with SK Chemicals to develop a 21-valent pneumococcal conjugate vaccine, with Phase II study data expected to guide Phase III development[287]. - Sanofi's collaboration with GSK led to the development of VidPrevtyn Beta, a COVID-19 vaccine that received full marketing authorization in the EU and UK[226]. Financial and Investment Strategies - Sanofi's capital allocation policy prioritizes organic investment, business development, and growing the annual dividend[161]. - Sanofi's preclinical research expenditures in the Pharmaceuticals segment increased to €884 million in 2022, up from €718 million in 2021, representing a 23.1% increase[290]. - Clinical development expenditure in the Pharmaceuticals segment rose to €3,460 million in 2022, compared to €2,892 million in 2021, marking an increase of 19.7%[290]. Regulatory and Market Challenges - The Inflation Reduction Act (IRA) is expected to reduce federal drug spending by approximately $290 billion over the next decade[324]. - 111 new drugs were added to the National Reimbursement Drug List (NRDL) in January 2023, representing a 36% increase over 2022, with an average price reduction of 60.1%[330]. - More than 500 drugs are targeted for inclusion in the volume-based procurement (VBP) policy by 2025, which will further drive down prices[331]. - The FDA has approved 36 biosimilars to date, with projected savings potentially exceeding $100 billion over the next five years[326]. - The three largest PBM group purchasing organizations now cover over 85% of US prescription drug claims, increasing pricing pressure on the industry[327]. - The new EU HTA regulation adopted in December 2021 will be implemented by 2025, introducing joint clinical assessments among Member States[333]. - The Biden administration is focused on lowering healthcare and prescription drug costs, impacting industry revenue growth and future innovation[327]. - In Europe, industry payback and mandatory rebates are expected to increase significantly in 2023, particularly in Germany and the UK[332]. - The effective period of patent protection for approved products is often significantly shorter than 20 years due to regulatory delays[337]. - The lack of effective intellectual property protection in emerging markets poses challenges for the company's operations[349]. Product Approvals and Market Presence - Aubagio (teriflunomide) is approved in over 80 countries, with generic competition expected in Q4 2023[177]. - Lemtrada (alemtuzumab) is approved in more than 70 countries and is available through a restricted distribution program in the US[178]. - Kevzara (sarilumab) is available in 20 countries and is under priority review for polymyalgia rheumatica by the FDA[180]. - Nexviazyme (avalglucosidase alfa-ngpt) was first approved in the US on August 6, 2021, and is anticipated to launch in additional markets in 2023[185]. - Xenpozyme (olipudase alfa) received approvals in Japan, Europe, and the US in 2022, addressing a significant unmet need for ASMD[188]. - Sarclisa (isatuximab) is approved in over 50 countries for relapsed refractory multiple myeloma and is under investigation for new indications[189]. - Libtayo (cemiplimab-rwlc) is approved in 37 countries for various cancers, including advanced cutaneous squamous cell carcinoma and non-small cell lung cancer[190]. - Jevtana (cabazitaxel) is approved in over 75 countries, with generic competition starting in Europe from March 2021 and patent expiration in the US in September 2021[192]. - Eloctate and Alprolix are extended half-life clotting-factor therapies for hemophilia A and B, respectively, marketed primarily in the US and several other countries[194][195]. - Enjaymo, approved in February 2022, is the first treatment for hemolytic anemia in adults with cold agglutinin disease, impacting an estimated 12,000 people in the US, Europe, and Japan[197][198]. - Toujeo, a long-acting insulin, has been launched in over 60 countries, including China since late 2020, and received expanded indications for adolescents and children[199]. - Lovenox/Clexane is marketed in over 100 countries, with generics available in the US and biosimilars in various European markets[200]. - Praluent, approved in more than 60 countries, is indicated for patients with uncontrolled LDL cholesterol and has been commercialized in the US by Regeneron since April 2020[202]. - Multaq is available in about 35 countries and is indicated for the prevention of atrial fibrillation recurrences[203]. - Sanofi is building a connected set of digital tools for diabetes management in collaboration with Abbott and others, demonstrating successful launches in several countries[208]. - Renagel and Renvela are marketed in over 85 countries, with generics available in the US and various European countries[211]. - Sanofi's Vaccines division is a world leader, supplying life-saving vaccines globally, including 395 million doses of inactivated polio vaccine to UNICEF from 2014 to 2022[219]. - The company has simplified its Consumer Healthcare portfolio from 250 brands to 140 brands in 18 months, enhancing operational efficiency[227]. Research and Development Focus - Sanofi's R&D strategy focuses on oncology, immunology, neurology, rare diseases, and rare blood disorders, with a goal of developing first-in-class or best-in-class medicines[232]. - The company has prioritized five transformative therapies in high unmet patient need areas, including fitusiran and efanesoctocog alfa for hemophilia[232]. - SAR445419, an off-the-shelf NK cell therapy, started enrollment in a new patient cohort in 2022 for acute myeloid leukemia[248]. - Itepekimab (SAR440340) is currently in Phase III for chronic obstructive pulmonary disease, with studies involving both former and current smokers[253]. - Tolebrutinib (SAR442168) is under investigation in Phase III trials for relapsing multiple sclerosis, with recruitment completed in December 2022 for one trial[262]. - Amlitelimab (SAR445229) is in Phase II for moderate to severe atopic dermatitis, with a Phase II study initiated for asthma in 2022[254]. - Eclitasertib (SAR443122) is undergoing a proof-of-concept Phase II study for cutaneous lupus erythematosus[256]. - SAR444200, a GPC3-based T cell engager, entered clinical development in 2022 for advanced solid tumors[252]. - SAR443820 (DNL788) is a RIPK1 inhibitor for ALS, with a Phase II study starting enrollment in 2022[264]. - SAR446159 (ABL301) is a bispecific antibody for Parkinson's disease, with a Phase I study initiated in December 2022[265]. - ALTUVIIIO (efanesoctocog alfa) received FDA approval on February 22, 2023, for hemophilia A, supported by Phase III study data showing clinically meaningful prevention of bleeds[270]. - Fitusiran (SAR439774) showed positive Phase III data for once-monthly prophylaxis in severe hemophilia A or B, with further data expected in the second half of 2023[270]. - Dupixent was approved in the US for prurigo nodularis in September 2022, becoming the first specific treatment for this condition[277]. - Nirsevimab received European and UK approvals in November 2022, with FDA acceptance in January 2023, aiming to provide passive immunity against RSV[285]. Intellectual Property and Legal Matters - Significant litigation is ongoing concerning patent protection for several products[357]. - Generic companies have filed Abbreviated New Drug Applications (ANDAs) challenging patents on small molecule products[358]. - The FDA may grant ANDA approval after a 30-month period, but this does not resolve patent disputes[359]. - In Europe, generic drug manufacturers can reference original product data only after data exclusivity expires[363]. - Trademarks are crucial for the commercial success of products, providing visibility and assurance to patients[365]. - The company vigorously defends its patent rights against competitors[360].

Sanofi SA (NASDAQ:SNY) Q4 2022 Results Conference Call February 3, 2023 8:00 AM ET Company Participants Eva Schaefer-Jansen - Head, IR Paul Hudson - CEO Bill Sibold - EVP, Specialty Care and President, North America Thomas Triomphe - EVP, Vaccines Olivier Charmeil - EVP, General Medicines Julie Van Ongevalle - EVP, Consumer Healthcare Jean-Baptiste de Chatillon - EVP and CFO John Reed - EVP and Global Head, R&D Conference Call Participants Graham Parry - BofA Peter Welford - Jefferies Richard Vosser - JPMor ...

Press Release Exhibit 99.2 Late-breaking Dupixent® (dupilumab) data at ERS 2022 show consistent efficacy and safety profile for up to two years in children aged 6 to 11 years with moderate-to-severe asthma Paris and Tarrytown, N.Y. September 5, 2022. Results from a Phase 3 open-label extension trial demonstrated the efficacy and safety profile of Dupixent® (dupilumab) as a maintenance therapy when added to other asthma medications was consistent for up to two years in children aged 6 to 11 years with uncont ...

Exhibit 99.1 | | TABLE OF CONTENTS | | --- | --- | | 1. | CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS 2 | | | CONSOLIDATED BALANCE SHEETS – ASSETS 2 | | | CONSOLIDATED BALANCE SHEETS — SHAREHOLDERS' EQUITY AND LIABILITIES 3 | | | 4 CONSOLIDATED INCOME STATEMENTS | | | CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME 5 | | | CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY 6 | | | CONSOLIDATED STATEMENTS OF CASH FLOWS 9 | | | NOTES TO THE CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE ...

Exhibit 99.1 Information Statement DISTRIBUTION OF SHARES OF EUROAPI TO THE SHAREHOLDERS OF SANOFI This information statement is intended to provide shareholders of Sanofi ("Sanofi") in specified jurisdictions other than France (as set forth under "Notice to Prospective Shareholders of EUROAPI", the "Jurisdictions") with information relating to the proposed pro rata distribution of approximately 58% of the outstanding shares of the EUROAPI company ("EUROAPI" or the "Company") by Sanofi to its shareholders ( ...

. FORM 20-F 2021 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 Or ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Or ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR ...

Exhibit 99.1 Sanofi announces positive Phase 1/2 study interim results for its first mRNA- based vaccine candidate PARIS – September 28, 2021 – Positive interim results from a Phase 1/2 study1 of Sanofi's mRNA-based COVID-19 vaccine candidate confirm the potential of recently-acquired Translate Bio's messenger RNA (mRNA) and lipid nanoparticle (LNP) platform and support Sanofi's mRNA strategy. The initial data from Phase 1/2 showed neutralizing antibody seroconversion (defined as 4-fold increase vs baseline ...

Exhibit 99.5 Press Release Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY) Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ³50% PD-L1 expression PARIS and TARRYTOWN, NY – June 25, 2021 - The European Commission (EC) has approved Sanofi and Regeneron's PD-1 inhibitor Libtayo® (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ³50% PD-L1 expression and no EG ...