A Multicenter, Open-Label, Single-Arm, Two-Cohort, Phase 3, Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Eliglustat Sublingual Film in Patients with Gaucher Disease Type 1. - NIL

Start Date02 Sep 2024

Sponsor / Collaborator

Kashiv Biosciences Pvt Ltd.

NCT06558773

/ Not yet recruitingPhase 2IIT

GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor and/or Regorafenib for Patients With Advanced/Metastatic pMMR/MSS Colorectal Cancer:an Open-Label, Randomized,Phase II Study

In this single-center,open-label, randomized, phase II study, the efficacy and feasibility of GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib therapeutic regimen will be evaluated in patients with advanced/metastatic proficient mismatch repair/microsatellite stable (pMMR/MSS) colorectal cancer (CRC).In this clinical trial, a total of 120 eligible patients were stratified randomly (with/without liver metastases) assigned to the 3 arms in a 1:1:1 ratio: experimental group-arm A(Eliglustat+Immune checkpoint inhibitor+Regorafenib),experimental group-arm B(Eliglustat+Immune checkpoint inhibitor) and comparator group-arm C(Regorafenib+Immune checkpoint inhibitor).It aims to: 1).assess the antitumor effects of GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib;2).evaluate the immunological or clinical predictive biomarkers for efficacy and toxicity; 3).detect the transformation of tumor microenvironment (TME) and dynamic changes of immune cells in peripheral blood after the treatment with GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib.

Start Date01 Sep 2024

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

NCT06523517

/ Not yet recruitingPhase 2IIT

A Single-center, Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Eliglustat in Chinese Pediatric Patients (≥12 to <18 Years Old) With Gaucher Disease Type 1 and Type 3

Primary Objective:
Evaluate the efficacy and safety of eliglustat in Chinese pediatric patients (≥12 to <18 years old) with Gaucher disease type 1 and type 3.
Secondary Objective:
Evaluate the quality of life in Chinese pediatric patients (≥12 to <18 years old) with Gaucher disease type 1 and type 3 treated with eliglustat.

Start Date01 Aug 2024

Sponsor / Collaborator

Peking Union Medical College Hospital

100 Clinical Results associated with Eliglustat

100 Translational Medicine associated with Eliglustat

100 Patents (Medical) associated with Eliglustat

194

Literatures (Medical) associated with Eliglustat

01 Jun 2025·Pediatric Nephrology

Model-informed repurposing of eliglustat for treatment and prophylaxis of Shiga toxin-producing Escherichia coli hemolytic-uremic syndrome (STEC-HUS) in children

Article

Author: Ter Heine, Rob ; Kartha, Reena V ; Wolthuis, David F G J ; Wijnsma, Kioa ; de Wildt, Saskia N ; Freriksen, Jolien J M ; Ter Avest, Mendy ; van de Kar, Nicole C A J

AbstractBackgroundShiga toxin-producing Escherichia coli hemolytic-uremic syndrome (STEC-HUS) is a severe illness predominantly affecting young children, with limited treatment options beyond supportive care. Eliglustat, approved for Gaucher disease, shows potential in reducing Shiga toxin binding to target glomerular endothelial cells in vitro, prompting interest as a treatment for STEC-HUS. However, it remains unknown what dose is likely to be effective and safe for treatment of STEC-HUS in the pediatric population. We hypothesize that effective and safe levels of eliglustat can be reached in children.MethodsWe identified pharmacokinetic targets of efficacy for treatment and prophylaxis of STEC-HUS based on a preclinical model and human cardiac safety data. Then, we developed oral and intravenous dosing regimens using population pharmacokinetic (popPK) simulations based on an existing model enriched to allow extrapolation to a simulated virtual pediatric population. These dosing regimens were then confirmed using a verified physiologically based pharmacokinetic (PBPK) model.ResultsWe simulated, using popPK data, oral and intravenous dosing regimens resulting in adequate target exposure in > 90% of all patients, with minimal expected risk for cardiotoxicity. Confirmation of these dosing regimens with PBPK modeling resulted in very similar exposure, with lower interindividual variability and minimal toxicity potential.ConclusionsBased on pharmacokinetic modeling, we developed oral and intravenous eliglustat dosing regimens that are likely safe and effective for treatment of STEC-HUS and prophylaxis in case of outbreaks of STEC infections. Clinical evaluation of these dosing regimens in children suspected of or diagnosed with STEC-HUS is required and should include assessment of pharmacokinetics, efficacy, and safety (e.g., ECG monitoring).Graphical abstract

01 May 2025·Molecular Genetics and Metabolism

Challenges in Gaucher disease: Perspectives from an expert panel

Review

Author: Tuason, Dominick A ; Prakalapakorn, S Grace ; Grabowski, Gregory A ; Weinreb, Neal J ; Kishnani, Priya S ; Alcalay, Roy N ; Rosenbloom, Barry E

This focused review concentrates on eight topics of high importance for Gaucher disease (GD) clinicians and researchers: 1) The consideration of GD as distinct types rather than a spectrum. A review of the literature clearly supports the view that there are distinct types of GD. Type 1 is characterized by the absence of primary neuronopathic involvement, while types 2 and 3 are characterized by progressive primary neuronopathic disease. 2) Neurologic and neuronopathic manifestations. A growing body of evidence indicates that the peripheral nervous system may be involved in GD type 1 and that there may also be signs and symptoms of central nervous system (CNS) disease in this group. However, GD type 1 is characterized by the absence of primary neuronopathic disease, whereas GD types 2 and 3 are characterized by progressive, albeit variable, primary neuronopathic disease. Abnormalities in saccadic eye movements have been suggested as being diagnostic for neuronopathic GD, but they may also occur in GD type 1 and in other inflammatory diseases. 3) The importance of whole GBA1 sequencing. This approach is superior to exome sequencing because of potential effects of deep intronic variants on gene expression. It also has the capacity to detect variant alleles that might be missed with gene panels. 4) Monoclonal gammopathy of undetermined significance (MGUS). The risks of MGUS, multiple myeloma, and non-Hodgkin's lymphoma are elevated in patients with GD compared to the general population and strong evidence indicates that lyso-Gb1 stimulates the formation of monoclonal immunoglobulins (M-protein) in patients with GD and MGUS. 5) Pulmonary involvement in GD. Pulmonary complications can be identified through spirometry in up to 45 % of patients with GD type 1 and 55 % of those with GD type 3. Limited evidence exists that enzyme replacement therapy (ERT) reduces the severity of these complications in patients with GD type 1. 6) Gaucheromas. These may occur in patients with GD types 1 or 3, but there is little detailed information about their inception, mechanisms underlying growth, cellular organization, and biochemical activities, and no definitive guidance for their management. Gaucheromas behave like benign (i.e. non-metastasizing) neoplasms, and it may be reasonable to classify them as such. 7) Bone and joint involvement. Dual-energy X-ray absorptiometry scans alone are insufficient for monitoring all changes in bone that may occur in patients with GD. Quantitative magnetic resonance imaging (MRI) techniques using Dixon quantitative chemical shift imaging have provided results that correlate with GD severity scores, bone complications, and biomarkers for GD bone involvement. Thoracic kyphosis is a common complication of GD types 1 and 3, and there is very limited information regarding the effects of ERT or substrate synthesis inhibition therapy (SSIT) on this condition. 8) Treatment initiation, selection, combination, and switching. Prompt initiation of treatment in pediatric patients is important as GD can lead to impaired growth, lower peak bone mass, and delayed puberty. These adverse outcomes can often be ameliorated or prevented with timely treatment. Either ERT or eliglustat, a SSIT agent, is suitable as first-line treatment of adults with GD. Studies of switching from ERT to eliglustat, or between different ERT products, have indicated that changing treatment is safe, although efficacy outcomes vary. A critical remaining issue is the lack of treatments capable of reaching the CNS to slow or halt the progression of neuronopathic disease in patients with GD type 2 or 3 and potentially reduce the risk of Parkinson's disease in GD type 1 patients and heterozygotes for GBA1 variants.

01 Feb 2025·Clinical Pharmacology & Therapeutics

Building Confidence in Physiologically Based Pharmacokinetic Modeling of CYP3A Induction Mediated by Rifampin: An Industry Perspective

Review

Author: Bolleddula, Jayaprakasam ; Mukherjee, Dwaipayan ; Reddy, Micaela B. ; Ramsden, Diane ; Prakash, Chandra ; Dowty, Martin E. ; Cabalu, Tamara D. ; Boulu, Laurent ; de Zwart, Loeckie ; Hariparsad, Niresh ; Fu, Qiang ; Umehara, Kenichi ; Shah, Kushal ; Badée, Justine ; Lewis, Gareth ; Taskar, Kunal S. ; Kotsuma, Masakatsu ; Rehmel, Jessica ; Leblanc, Alix F. ; Liang, Guiqing ; Pilla Reddy, Venkatesh ; Parrott, Neil

Physiologically‐based pharmacokinetic (PBPK) modeling offers a viable approach to predict induction drug–drug interactions (DDIs) with the potential to streamline or reduce clinical trial burden if predictions can be made with sufficient confidence. In the current work, the ability to predict the effect of rifampin, a well‐characterized strong CYP3A4 inducer, on 20 CYP3A probes with publicly available PBPK models (often developed using a workflow with optimization following a strong inhibitor DDI study to gain confidence in fraction metabolized by CYP3A4, fm,CYP3A4, and fraction available after intestinal metabolism, Fg), was assessed. Substrates with a range of fm,CYP3A4 (0.086–1.0), Fg (0.11–1.0) and hepatic availability (0.09–0.96) were included. Predictions were most often accurate for compounds that are not P‐gp substrates or that are P‐gp substrates but that have high permeability. Case studies for three challenging DDI predictions (i.e., for eliglustat, tofacitinib, and ribociclib) are presented. Along with parameter sensitivity analysis to understand key parameters impacting DDI simulations, alternative model structures should be considered, for example, a mechanistic absorption model instead of a first‐order absorption model might be more appropriate for a P‐gp substrate with low permeability. Any mechanisms pertinent to the CYP3A substrate that rifampin might impact (e.g., induction of other enzymes or P‐gp) should be considered for inclusion in the model. PBPK modeling was shown to be an effective tool to predict induction DDIs with rifampin for CYP3A substrates with limited mechanistic complications, increasing confidence in the rifampin model. While this analysis focused on rifampin, the learnings may apply to other inducers.

News (Medical) associated with Eliglustat

30 Jan 2025

·www.globenewswire.com

Press Release: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025

Sanofi: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025 Paris, January 30, 2025 Q4: sales growth of 10.3% at CER1 and business EPS2 of €1.31 Pharma launches up 56.5%, reaching sales of €0.8 billion, 8% of total sales, led by ALTUVIIIODupixent sales up 16.0% to €3.5 billionVaccines sales up 10.8% to €2.2 billion, driven by Beyfortus sales in EuropeBusiness EPS of €1.31, -11.0% at CER and -14.9% reported; IFRS EPS of €0.54 FY: double-digit sales growth and business EPS guidance exceeded Sales totaled €41.1 billion, an increase of 11.3% at CERSales targets exceeded: Dupixent >€13 billion and Beyfortus blockbuster status (€1.7 billion) in its first full yearResearch and Development expenses reached €7.4 billion, up 14.6%, in line with commitmentsBusiness EPS of €7.12, +4.1% at CER, above guidance, and -1.8% reported; IFRS EPS of €4.59The Board of Directors met on January 29, 2025; proposes a dividend of €3.92 for 2024, 30th year of consecutive increases Pipeline: increased investment and progress Q4: four regulatory approvals: Dupixent EoE (children) (EU), Kevzara PMR (EU), Cerdelga GD1 (children) (EU), Efluelda flu (JP)3FY: 14 regulatory approvals of medicines and vaccines, 21 regulatory submission acceptances, and eight positive phase 3 readouts emphasize a positive and improving pipeline momentum Further progress towards a focused biopharma business Intention to sell a controlling stake in Opella consumer health at an attractive valuation; closing in Q2 2025 at the earliest4 Guidance In 2025, sales are anticipated to grow by a mid-to-high single-digit percentage at CER5. Sanofi confirms the expectation of a strong rebound in business EPS with growth at a low double-digit percentage at CER (before share buyback).6Sanofi intends to execute a share buyback program in 2025 of €5 billion. Shares will be purchased preferably through block trades and in the open market with the purpose of cancellation. Paul Hudson, Chief Executive Officer: “We achieved double-digit sales growth in 2024 while pursuing the transformation of the company. Innovation was a key driver of our growth as launches already contributed 11 percent of sales, with Beyfortus becoming a blockbuster in its first full year of sales. We exceeded our business EPS guidance. In 2024, we announced an intention to sell a controlling stake in Opella consumer health, which will make Sanofi a focused, science-driven biopharma company. We increased R&D investments and achieved significant progress with our pipeline in 2024, including positive phase 3 study results for new medicines such as rilzabrutinib in rare diseases and tolebrutinib in multiple sclerosis. As we enter 2025, we expect continued, solid growth in sales and a strong rebound in earnings. We are also confident in the mid to long-term growth prospects of Sanofi, supported by ongoing launches, Dupixent (currently expected to reach sales of around €22 billion in 20307, in line with the current ambition), and expected future launches from our pipeline.” Q4 2024 Change Change at CER FY 2024 Change Change at CER IFRS net sales reported €10,564m +9.1% +10.3% €41,081m +8.6% +11.3% IFRS net income reported €683m — — €5,744m +6.4% — IFRS EPS reported €0.54 — — €4.59 +6.5% — Free cash flow8 €2,340m -25.5% — €5,955m -19.6% — Business operating income €2,078m -11.8% -7.7 % €11,343m +1.5% +7.6% Business net income €1,642m -15.1% -11.2 % €8,912m -1.8% +4.1% Business EPS €1.31 -14.9% -11.0% €7.12 -1.8% +4.1% 1 Changes in net sales are at constant exchange rates (CER) unless stated otherwise (definition in Appendix 9).2 To facilitate an understanding of operational performance, Sanofi comments on the business net income statement which is a non-IFRS financial measure (definition in Appendix 9). The income statement is in Appendix 3 and a reconciliation of reported IFRS to business net income is in Appendix 4.3 For the definition of medical and scientific terms, please see the first use of the word in the Pipeline update section.4 Subject to finalization of definitive agreements and subject to obtaining regulatory approvals from the competent authorities.5 In 2025, sales growth will exclude any impact from hyperinflation. In 2024, it is estimated that sales growth benefited by 1.8 percentage points.6 Applying average January 2025 exchange rates, the currency impacts are estimated between +2% and +3% on sales and +2% and +3% on business EPS.7 At CER.8 Free cash flow is a non-IFRS financial measure (definition in Appendix 9). Attachment Press_Release

Phase 3Clinical ResultFinancial StatementBiosimilarDrug Approval

28 Oct 2021

·www.biospace.com

Sanofi : Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1)

Paris, October 28, 2021 Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1) Q3 2021 sales grew double digit to €10.4 billion (up 10.1%) due to strong growth from Dupixent®, Vaccines and CHC Specialty Care sales increased 20.2% with strong contribution from Dupixent® (+54.6% to €1,410 million) Vaccines up 16.5%, with record quarterly sales driven by differentiated flu vaccines and meningitis franchise recovery CHC increased 11.1% driven by growth of Pain care and Digestive Wellness categories General Medicines sales down 1.7% while transformation of business model supports core assets growth (up 4.5%) Q3 2021 business EPS(2) growth of 19.1% at CER driven by sales performance and efficiencies Business EPS(2) was €2.18, up 19.1% on a reported basis BOI margin reached 34.1% up 2.2 ppts reflecting improvement in Gross margin and continued expense management IFRS EPS was €1.85 (up 19.4 %) Progress on Corporate Social Responsibility strategy Carbon neutrality target accelerated to 2030; a 2050 net zero objective established Sanofi ranked #1 in the European pharma sector by ESG rating agency Vigeo Eiris (part of Moody’s ESG Solutions) Key milestone and regulatory achievements on R&D transformation Positive pivotal phase 3 readouts for Dupixent® in chronic spontaneous urticaria and infant atopic dermatitis (6 months to 5 years) Nexviazyme® approvals in U.S. and Japan Submissions of sutimlimab in the U.S. and olipudase alfa in Japan under the Sakigake pathway Acquisition of Translate Bio completed, first positive clinical data read-out validating the mRNA platform Full-year 2021 business EPS guidance revised upward(1) Sanofi now expects 2021 business EPS(2) to grow around 14% at CER(3), barring unforeseen major adverse events. Applying average October 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -3.5% to -4.5% Sanofi Chief Executive Officer, Paul Hudson, commented: “Sanofi has delivered outstanding financial results in the third quarter. Double-digit sales growth in the period was driven by the remarkable performance of Dupixent®, record sales of Vaccines and business momentum in Consumer Healthcare, all in line with our strategic priorities. As a result of our sales performance and strong earnings, we have upgraded our full-year EPS guidance growth to around 14% at CER. In R&D, our growing pipeline of potentially transformative therapies has progressed, including the most recent positive readouts for Dupixent® in Eosinophilic esophagitis and Prurigo nodularis as well as the U.S. approval and launch of Nexviazyme® in Pompe disease. With higher R&D investment behind our pipeline assets and the two targeted bolt-on acquisitions of Translate Bio and Kadmon, we have further increased our commitment to bring innovative medicines to patients and drive future growth. Aligned with our contract with society and leading up to COP 26, we have set ourselves new ambitious ESG targets to reduce carbon emissions and accelerate our actions in fighting global climate change.” Q3 2021 Change Change at CER 9M 2021 Change Change at CER IFRS net sales reported €10,432m +10.1% +10.1% €27,767m +4.2% +8.2% IFRS net income reported(4) €2,317m +18.7% _ €5,093m -54.7% — IFRS EPS reported €1.85 +19.4% _ €4.07 -54.6% — Free cash flow(5) €2,202m +16.9% _ €5,555m +1.9% — Business operating income €3,558m +17.5% +17,3% €8,461m +9.7% +15.0% Business net income(2) €2,736m +19.0% +18.8% €6,484m +11.4% +16.9% Business EPS(2) €2.18 +19.1% +19.1% €5.18 +11.6% +17.2% Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7) (1) Sanofi already raised its full-year 2021 business EPS growth guidance to around 12% at CER on July 29; (2) 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 Q3 2021 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (3) 2020 restated business EPS was €5.86; (4) 9M 2021 IFRS net income reported reflected capital gain from sales of Regeneron shares in Q2 2020; (5) Free cash flow is a non-GAAP financial measure (definition in Appendix 7) 2021 third-quarter and first nine months Sanofi sales ---------------------------- Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER1 ---------------------------- In the third quarter of 2021, Sanofi sales were €10,432 million, up 10.1% on a reported basis. Exchange rate movements had a neutral effect, the negative impact of the U.S. dollar, Japanese yen and Turkish lira was offset by the increase of the Chinese Yuan and some other currencies. In the first nine months Sanofi sales reached €27,767 million, up 4.2% on a reported basis. Exchange rate movements had a negative effect of 4.0 percentage points. At CER, company sales were up 8.2%. Global Business Units Third-quarter 2021 operating income Third-quarter business operating income (BOI) increased 17.5% to €3,558 million. At CER, BOI increased 17.3%. The ratio of BOI to net sales increased 2.2 percentage points to 34.1% (34.0% at CER). In the first nine months, BOI increased 9.7% to €8,461 million. At CER, BOI increased 15.0%. The ratio of business operating income to net sales increased 1.6 percentage points to 30.5% (30.8% at CER). Pharmaceuticals Third-quarter 2021 Pharmaceutical sales increased 7.8% to €6,855 million, mainly driven by the Specialty Care portfolio (up 20.2%) with continued strong performance of Dupixent® while sales in General Medicines decreased 1.7%. In the first nine months, Pharmaceuticals sales increased 7.7% to €20,051 million reflecting the strong performance of Specialty Care and General Medicines core assets. Specialty Care Dupixent Net sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER Total Dupixent® 1,410 +54.6 % 3,700 +52.5 % In the third quarter, Dupixent® (collaboration with Regeneron) sales increased 54.6% to €1,410 million. In the U.S., Dupixent® sales of €1,061 million (up 47.7%) were driven by continued strong demand in atopic dermatitis (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 45% (year-over-year) and new-to-brand prescriptions (NBRx) grew 23% despite fewer in-person physician visits, which remain slightly below the pre-COVID level. In Europe, third-quarter Dupixent® sales grew 78.4% to €173 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Japan, sales were €78 million (up 68.8%). In the first nine months, Dupixent® sales reached €3,700 million, up 52.5%. Neurology and Immunology Net sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER Aubagio® 483 -3.8 % 1,477 -1.7 % Lemtrada® 20 -16.7 % 63 -27.2 % Kevzara® 83 +42.4 % 196 +15.3 % Total Neurology and Immunology 586 +0.3 % 1,736 -1.4 % In the third quarter, Neurology and Immunology sales remained stable to €586 million, reflecting strong Kevzara® sales which were offset by lower Aubagio® sales. In the first nine months, Neurology and Immunology sales were down 1.4% reflecting decreased sales of Lemtrada® and Aubagio. Aubagio® sales decreased 3.8% in the third quarter to €483 million due to lower sales in the U.S. reflecting increased competition which was partially offset by higher sales in Europe and the Rest of the World. Third-quarter Kevzara® (collaboration with Regeneron) sales increased 42.4% to €83 million due to an increase in global demand for IL-6 receptor blockers and the temporary tocilizumab shortage. Rare Disease Net sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER Myozyme® / Lumizyme® 266 +10.4 % 749 +8.4 % Fabrazyme® 209 +3.4 % 621 +5.7 % Cerezyme® 159 +0.6 % 502 +1.1 % Aldurazyme® 57 +5.5 % 180 +7.3 % Cerdelga® 64 +5.0 % 187 +10.9 % Others Rare Disease 24 +4.3 % 69 +10.8 % Total Rare Disease 779 +5.4 % 2,308 +6.1 % In the third quarter, Rare Disease sales increased 5.4% to €779 million driven by Pompe franchise performance. In the first nine months, sales of Rare Disease increased 6.1% reflecting growth across all three geographic regions. Third-quarter Myozyme®/Lumizyme® sales increased 10.4% to €266 million supported primarily by new patient accruals across geographic regions. Third-quarter Fabrazyme® sales increased 3.4% to €209 million driven by higher demand in Europe and the Rest of the World region, reflecting new patient accruals and improved treatment compliance. Sales of the Gaucher franchise (Cerezyme® + Cerdelga®) increased 1.8% (to €223 million) in the third quarter. Over the period, Cerezyme® sales increased 0.6% to €159 million, reflecting growth in the U.S. and Rest of World region. In Europe Cerezyme® sales were down 4.8% as Cerdelga® sales were up 5.0% globally driven by new patient accruals in Europe. Oncology Net sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER Jevtana® 105 -20.9 % 345 -10.9 % Sarclisa® 48 +276.9 % 122 +605.6 % Fasturtec® 37 -9.5 % 111 +1.8 % Libtayo® 35 +61.9 % 94 +95.8 % Total Oncology 225 +8.1 % 672 +19.3 % Third-quarter and first-nine months sales of Oncology increased 8.1% (to €225 million) and 19.3%, respectively, driven by the Sarclisa® and Libtayo® launches which more than offset the impact of Jevtana® generic competition in Europe. Third-quarter Jevtana® sales decreased 20.9% to €105 million following the entry of generic competition in certain European markets (down 58.3%) at the end of March. In the U.S., sales were up 1.6%, where the Jevtana® composition of matter patent has expired in September 2021. However, Sanofi has filed patent infringement suits against generic on Jevtana® under Hatch-Waxman in the U.S. District Court for the District of Delaware asserting three method of use patents, two of which (US 10,583,110 and US 10, 716,777) expire in October 2030 and the other one (US 8,927,592) expires in April 2031 including 6-month pediatric exclusivities. Sanofi has reached settlement agreements with some of the defendants and the suit against the remaining defendants is ongoing. No trial dates has been scheduled 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. Separately, Jevtana® has been granted a data exclusivity on the CARD clinical study results which expires in December 2023. Third-quarter Sarclisa® sales were €48 million (versus €13 million in the third quarter of 2020) driven by additional country launches in Europe (€17 million), higher sales in the U.S (€18 million) and in the Rest of the world region (€13 million) driven by the uptake in Japan. Libtayo® (collaboration with Regeneron) sales were €35 million (up 61.9%) in the third quarter driven by increased demand in metastatic cutaneous squamous cell carcinoma (CSCC) as well as additional country launches. Libtayo® sales in the U.S. are reported by Regeneron. Rare Blood Disorders Net sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER Eloctate® 144 -4.6 % 422 -7.3 % Alprolix® 101 -6.4 % 301 -4.8 % Cablivi® 42 +32.3 % 126 +56.6 % Total Rare Blood Disorders 287 -1.4 % 849 -0.4 % In the third quarter, Rare Blood Disorders franchise sales decreased 1.4% (€287 million). Excluding industrial sales to Sobi, third-quarter sales were up 7.1% mainly driven by Cablivi®. Alprolix® and Eloctate® industrial sales to Sobi are expected to be significantly lower in 2021 than in 2020 due to a change in the supply agreement. In the first nine months sales of Rare Blood Disorders decreased 0.4% and were up 9.8.% when excluding industrial sales to Sobi. Eloctate® sales were €144 million in the third quarter, down 4.6%. Excluding industrial sales to Sobi, Eloctate sales were up 2.2% driven by higher U.S. sales (+3.7%) which benefited from buying patterns in the quarter . Sales in the Rest of the World were down 25.0% reflecting lower industrial sales to Sobi (which are recorded in this region). Third-quarter Alprolix® sales were down 6.4% to €101 million. Excluding industrial sales to Sobi, Alprolix® sales were up 6.3% driven by U.S. sales (up 5.0%) which benefited from buying patterns in the quarter. Sales in the Rest of the World were down 37.9% reflecting lower industrial sales to Sobi (which are recorded in this region). Cablivi® generated sales of €42 million (up 32.3%) in the third quarter driven by launches in Europe (up 120.0% to €22 million). In the U.S., sales of the product were €19 million, down 9.5% reflecting the impact of the COVID-19 environment on treatment initiations with Cablivi® at the hospital level. General Medicines Third quarter General Medicines sales decreased 1.7% to €3,568 million. The growth of core assets2 (up 4.5% to €1,437 million and up 5.6% excluding Praluent® U.S. sales) was more than offset by the non-core assets sales decrease (down 6.3% to €1,923 million) mainly reflecting lower Lantus® sales in the U.S., portfolio streamlining (-1.3 ppt impact) and a decline in Aprovel®/Avapro® sales. Third-quarter Industrial sales3 were €208 million up 2.5%. Excluding portfolio streamlining, third quarter General Medicines sales were down 0.7% (- 1.0 ppt impact). In the first nine months, General Medicines sales were down 0.6% to €10,786 million. During the same period, sales of the core assets were €4,339 million up 6.8%, driven by strong performance of Lovenox®, Toujeo® and Thymoglobulin®. Non-core assets sales were €5,859 million, down 5.8% reflecting portfolio streamlining (-2.0 ppt), as well as lower Lantus® and Aprovel®/Avapro® sales. Over the same period, Industrial sales were €588 million up 4.2%. Excluding portfolio streamlining, General Medicines sales were up 0.5 % (-1.1 ppt impact). Diabetes Net sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER Lantus® 622 -5.9 % 1,911 -4.1 % Toujeo® 239 +11.1 % 739 +7.9 % Total glargine 861 -1.7 % 2,650 -1.0 % Soliqua® 51 +27.5 % 141 +28.7 % Other diabetes 211 -6.6 % 653 -3.7 % Total Diabetes 1,123 -1.7 % 3,444 -0.6 % In the third quarter, global Diabetes sales decreased 1.7% to €1,123 million. Sales growth in the Rest of the Word (up 9.3%) was more than offset by lower sales in the U.S. (down 13.4%) and Europe (down 3.2%). In the first nine months, Diabetes sales were down 0.6% mainly as a result of lower Lantus® sales partially offset by growth from Toujeo® and Soliqua®. Third-quarter Toujeo® sales increased 11.1% to €239 million reflecting growth across all geographies and strong growth in the Rest of World region (up 20.0%). Lantus® sales were €622 million, down 5.9% in the third quarter, reflecting lower sales in the U.S. and Europe due to a continued decline in average U.S. net price, increasing use of Toujeo® and biosimilar glargine competition. In the Rest of World region, Lantus® sales were up 10.1% driven by China. Third-quarter Soliqua® sales increased 27.5% to €51 million driven by growth in all three geographic regions. In the Rest of World region, third-quarter Soliqua® sales grew 40.0% mainly due to new launches. Cardiovascular and Established Rx Products Net sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER Lovenox®* 383 +4.4 % 1,151 +19.1 % Plavix®* 222 +6.3 % 707 +1.0 % Aprovel®/Avapro® 107 -21.8 % 307 -29.4 % Thymoglobulin® 91 +4.6 % 263 +16.1 % Multaq® 79 0.0 % 230 +4.3 % Praluent® 59 +18.0 % 163 -15.8 % Mozobil® 60 +7.1 % 170 +13.5 % Generics 172 -10.9 % 566 -0.3 % Other 1,064 -4.0 % 3,197 -5.0 % Total Cardiovascular and Established Rx Products 2,237 -2.1 % 6,754 -1.0 % *Excluding Auto generics In the third quarter, Cardiovascular andEstablished Rx Products sales decreased 2.1% to €2,237 million. The performance of the core assets including Lovenox®, Plavix®, Thymoglobulin®, Mozobil® and Praluent® was more than offset by lower sales of Aprovel®/Avapro® and generics as well as the impact of the divestments of non-core products. In the first nine months, Cardiovascular and Established Rx Products sales were down 1.0% (up 0.1% excluding Praluent® U.S. sales) mainly due to lower Aprovel®/Avapro® sales and the divestments which offset strong growth of several core assets. Third-quarter Lovenox® sales increased 4.4% to €383 million, driven by strong sales in Rest of World region (up 9.5%). COVID-19 related demand continued to be strong (guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients). However, growth performance was impacted by a comparable high base in the third quarter of 2020, supply limitations and biosimilar competition in Europe (down 1.8%). Plavix® sales were up 6.3% in the third quarter to €222 million due to higher sales in Rest of World (up 9.2%) driven by China (up 16.7% to €90 million) largely offsetting lower sales in Japan and Europe. Third-quarter Aprovel®/Avapro® sales were down 21.8% to €107 million reflecting supply constraints. Third-quarter Praluent® sales increased 18.0% to €59 million, reflecting the restructuring of the collaboration with Regeneron effective April 1, 2020. Sanofi has sole responsibility for Praluent® outside the U.S. while Regeneron has sole responsibility for Praluent® in the U.S. Excluding U.S. sales in the comparable quarter last year, higher Praluent® sales (up 63.9%) were driven by the launch in China and strong performance in Europe. Multaq® third quarter sales were stable at €79 million, reflecting U.S. sales growth which was offset by lower sales in Europe. Pharmaceuticals business operating income In the third quarter, business operating income (BOI) of Pharmaceuticals increased 2.8% to €2,409 million (up 1.7% at CER). The ratio of BOI to net sales decreased by 1.7 percentage points to 35.1%. At CER, the ratio decreased 2.0 percentage points reflecting Regeneron MAbs alliance and increased R&D expenses in priority assets and commercial expenses in Specialty Care growth drivers, despite an improvement of the gross margin ratio. In the first nine months, business operating income of Pharmaceuticals decreased 1.2% to €7,320 million (up 3.1% at CER). The ratio of BOI to net sales decreased by 1.7 percentage points to 36.5% (36.6% at CER). Vaccines Net sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER Polio/Pertussis/Hib vaccines (incl. Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®) 563 +1.8 % 1,616 +3.1 % Influenza vaccines (incl. Vaxigrip®, Fluzone HD®, Fluzone® & Flublok®) 1,339 +25.5 % 1,535 +23.9 % Meningitis/Pneumo vaccines (incl. Menactra®) 253 +18.7 % 567 +36.2 % Adult Booster vaccines (incl. Adacel®) 158 +4.6 % 364 +8.7 % Travel and other endemic vaccines 82 +16.9 % 215 -1.3 % Other vaccines 27 +8.7 % 62 +18.5 % Total Vaccines 2,422 +16.5 % 4,359 +13.8 % Third-quarter Vaccines sales grew 16.5% to €2,422 million driven by influenza vaccines performance and meningitis vaccination recovery in the U.S. In the first nine months, Vaccines sales grew 13.8% due to the strong performance of the influenza vaccines franchise and a recovery of meningitis vaccines more than offsetting the negative COVID-19 impact on the travel vaccines. In the third quarter, Polio/Pertussis/Hib (PPH) vaccines sales increased 1.8% to €563 million. In Europe, PPH sales decreased 11.2% reflecting unfavorable phasing effect and lower birth rates due to the pandemic. In Rest of World, PPH sales were up 3.5% supported by Pentaxim® in China and Polio vaccines which largely offset the impact of lower birth rates. In the U.S., PPH sales increased 6.8% due to positive inventory fluctuation. VaxelisTM, the first and only hexavalent combination vaccine approved in the U.S., was launched in the U.S. in June 2021. Developed as part of a joint-partnership between Sanofi and Merck, VaxelisTM in-market sales are not consolidated and the profits shared equally between the two parties. As Vaxelis™ is expected to partly replace Pentacel® sales, PPH sales in the U.S. are expected to decrease going forward. Influenza vaccines sales increased 25.5% in the third quarter to €1,339 million as a result of earlier shipments in the U.S and a strong increase in differentiated influenza vaccines in Europe driven by Germany which adopted a preferential recommendation for Efluelda® for people above 60 years old. Influenza vaccines sales in the U.S and in Europe grew 18.1% (to €982 million) and 87.8% (to €247 million), respectively. Third-quarter Meningitis sales were up 18.7% to €253 million mainly with the recovery of meningitis vaccination in the U.S. and in Middle East in conjunction with the U.S. launch of MenQuadfi® in March 2021. Adult Booster vaccines sales grew 4.6% in the third quarter to €158 million, due to the gradual recovery of Adacel® vaccinations in the U.S. Third-quarter Travel and other endemic vaccines sales increased 16.9% versus a low 2020 basis. Vaccines business operating income In the third quarter, business operating income (BOI) increased 29.8% to €1,359 million reflecting the strong sales growth. At CER, BOI increased 29.5%. The ratio of BOI to net sales was 56.1% (versus 50.4% in the third quarter of 2020) reflecting a favorable product mix driven by influenza vaccines and Meningitis vaccines as well as good industrial performance. In the first nine months, BOI increased 30.7% (up 33.0% at CER) to €1,957 million reflecting strong sales performance as well as the payment from Daiichi Sankyo in the first quarter of 2021. The ratio of BOI to net sales increased 6.6 percentage points to 44.9% (44.7% at CER). Consumer Healthcare Net sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER Allergy 142 +17.4 % 485 +2.2 % Cough, Cold and Flu 94 +4.4 % 204 -30.9 % Pain Care 290 +18.2 % 818 +7.3 % Digestive Wellness 282 +16.0 % 855 +21.8 % Physical Wellness 85 -7.7 % 244 -5.7 % Mental Wellness 53 +8.2 % 160 +16.8 % Personal Care 135 +5.4 % 387 +2.8 % Non-Core / Others 74 +4.2 % 204 -5.8 % Total Consumer Healthcare 1,155 +11.1 % 3,357 +4.2 % In the third quarter, Consumer Healthcare (CHC) sales increased 11.1% to €1,155 million driven by growth in all three geographic regions and the performance of the Digestive Wellness category, as well as the Pain Care category which also benefited from COVID-19 vaccinations. In the first nine months CHC sales increased 4.2% mainly due to the growing sales in Digestive Wellness, Pain Care and Mental Wellness categories which more than offset a weak cough and cold season last winter and the divestments of non-core products (-0.6 ppt impact). In the U.S., third-quarter CHC sales increased 16.4% to €289 million driven by strong growth of Pain Care, Personal Care (driven by Gold bond) and Digestive Wellness categories as well as Allergy which benefited from a low base for comparison. In Europe, third-quarter CHC sales increased 3.1% to €335 million mainly reflecting growth of Pain Care and Digestive categories which more than offset lower sales from the Cough, Cold and Flu category due to the impact of social distancing measures. In Rest of World, third-quarter CHC sales increased 13.9% to €531 million, supported by strong growth of Pain Care and Digestive Wellness categories as well as higher sales from the Allergy category. CHC business operating income In the third quarter, business operating income (BOI) of CHC increased 44.1% (44.4% at CER) to €464 million reflecting higher sales and a strict control of operational expenses. The ratio of BOI to net sales increased 9.3 percentage point to 40.2% versus the prior year and included a €77 million capital gain related to divestment of non-strategic assets. In the first nine months of 2021, BOI of CHC increased 8.0% (up 14.5% at CER) to €1,195 million. The ratio of BOI to net sales increased 2.7 percentage points to 35.6% (36.1% at CER). Company sales by geographic region Sanofi sales (€ million) Q3 2021 Change at CER 9M 2021 Change at CER United States 4,477 +13.4 % 10,565 +13.4 % Europe 2,483 +8.9 % 6,955 +5.3 % Rest of the World 3,472 +6.7 % 10,247 +5.0 % of which China 782 +12.8 % 2,162 +8.5 % of which Japan 423 +13.3 % 1,253 +2.1 % of which Brazil 198 +14.8 % 651 +16.7 % of which Russia 139 -0.7 % 439 -3.8 % Total Sanofi sales 10,432 +10.1 % 27,767 +8.2 % Third-quarter sales in the U.S. increased 13.4% to €4,477 million supported by the strong performance of Dupixent® and double-digit growth of Vaccines and CHC. In the first nine months, U.S. sales grew 13.4%, mainly reflecting Dupixent® and Vaccines performance. In Europe sales increased 8.9% in the third quarter to €2,483 million mainly driven by strong Vaccines growth and Dupixent® performance. In the first nine months, European sales increased 5.3% due to the growth of Specialty Care products driven by Dupixent® and Vaccines which more than offset lower sales of General Medicines and CHC. In Rest of World sales increased 6.7% to €3,472 million in the third quarter, driven by the performance of Dupixent®, General medicine and CHC. Sales in China increased 12.8% to €782 million mainly sustained by Dupixent®, Vaccines, CHC and General Medicines performance. In Japan, third-quarter sales increased 13.3% to €423 million reflecting the strong performance of Dupixent® and Sarclisa®. In Rest of World first-nine months sales increased 5.0% mainly supported by growth of Dupixent®, Oncology, General Medicines and CHC. R&D update at the end of the third quarter 2021 Regulatory update The U.S. Food and Drug Administration (FDA) approvedNexviazyme® (avalglucosidase alfa) for the treatment of patients one year of age and older with late-onset Pompe disease. Nexviazyme® was also approved in Japan. Nexviazyme® is a long-term enzyme replacement therapy targeting the mannose-6-phosphate receptor, the key pathway for cellular uptake of enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells. The approval was based on the Phase 3 COMET study, showing clinically meaningful improvements in respiratory function and movement endurance measures in people with late-onset Pompe disease. The European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Nexviazyme® (avalglucosidase alfa), for the treatment of Pompe disease. However, they considered that avalglucosidase alfa does not qualify as a New Active Substance (NAS), leading Sanofi to be requesting a re-examination of the CHMP opinion in relation to the NAS conclusion. The FDA accepted the resubmission of the Biologics License Application (BLA) for sutimlimab, its investigational therapy for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). The FDA is reviewing the BLA under priority review with a PDUFA action date of February 5, 2022. Sutimlimab has previously received Breakthrough Therapy Designation (BTD) and Orphan Drug Designations (ODD) from the FDA. Olipudase alfa, an investigational recombinant human acid sphingomyelinase for the treatment of Acid Sphingomyelinase Deficiency (ASMD), was submitted in Japan on September 30th, through the Sakigake regulatory pathway. The FDA accepted for priority review of the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab) to treat patients in 2L with recurrent or metastatic cervical cancer. The FDA approvedfexinidazole, the first 10-day once-a-day oral treatment for Trypanosoma brucei gambiensesleeping sickness, in patients 6 years of age and older and weighing at least 20 kg. Both first stage and second stage of the disease are targeted, in which the parasites have crossed the blood-brain barrier, causing patients to suffer from neuropsychiatric symptoms. The China National Medical Products Administrations (NMPA) approved the use of Dupixent® (dupilumab), for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The FDA granted Fast-Track Designation for SAR443820, a RIPK1 inhibitor currently in Phase 1, for the amyotrophic lateral sclerosis (ALS) indication. The FDA granted ODD for SAR445088 (formerly known as BIVV020), a complement C1s inhibitor currently in Phase 2, for the treatment of Chronic inflammatory demyelinating polyneuropathy (CIDP). Portfolio update Phase 3: Dupixent®met its primary and all key secondary endpoints in Study A (the first of two trials) of the pivotal LIBERTY CUPID clinical program, showing a nearly doubled reduction in itch and urticaria activity scores, compared to antihistamines (standard-of-care treatment), in patients with moderate-to-severe chronic spontaneous urticaria (CSU). Study B of the clinical trial evaluates Dupixent® in adults and adolescents who remain symptomatic despite standard-of-care treatment and are intolerant or incomplete responders to an anti-IgE therapeutic (omalizumab). This study is expected to read out in H1 2022. CSU is an inflammatory skin disease, affecting more than 300,000 patients in the U.S. alone. The pivotal trial evaluating Dupixent® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, met its primary and all secondary endpoints. The data show adding Dupixent® to standard of care topical corticosteroids (TCS) significantly reduced the overall disease severity and improved the skin clearance, itch and health-related quality of life measures at 16 weeks compared to TCS alone. Detailed data from the MELODY study for nirsevimab to prevent respiratory illness caused by RSV (Respiratory Syncytial Virus) in infants was presented at the IDWeek congress showing a 74.5% reduction in medically attended LRTI (Lower Respiratory Tract Infections) after 5 months of follow up. The study evaluating Libtayo® in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival primary endpoint, compared to chemotherapy alone, in first-line treatment of patients with advanced non-smallcell lung cancer(NSCLC), with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels. Results were presented at the 2021 European Society of Oncology (ESMO) congress. The PEGASUS phase 3 trial, evaluating rilzabrutinib, a BTK inhibitor for the treatment of pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints. The proportion of patients meeting the primary endpoint on Rilzabrutinib, was not significantly different from placebo. Rilzabrutinib continues to be investigated in a Phase 3 trial for the treatment of immune thrombocytopenia, a rare blood disorder, and in a Phase 2 study for the autoimmune condition IgG4-related disease. Additional Phase 2 studies in immunological and rare blood disorders diseases including asthma, atopic dermatitis, chronic spontaneous urticaria and warm autoimmune hemolytic anemia are planned to start in 2021. A potential filing date for fitusiran, a small interference RNA therapy in development for the treatment of people with hemophilia A or B, with or without inhibitors, has been moved to 2024 due the introduction of a lower dose cohort in the ongoing phase 3 studies. The lower dose may be available to those patients currently on 50 mg every other month with anti-thrombin levels below the lower threshold of 15% and may enable them to continue to receive prophylactic treatment with fitusiran. A new phase 3 study evaluating the safety pro Nexviazyme® in infantile-onset Pompe Disease was initiated in children from 6 months to 17 years. Patient enrollment is ongoing in EU and ROW in the phase 3 multicenter, open-label ELIKIDS study of Cerdelga® in pediatric patients with Gaucher Disease Type 1 and Type 3, under the pediatric investigation plan (PIP) as part of the overall clinical development plan. Submission is currently planned for 2025. Given the integral nature of the project it is not detailed anymore on the overall Sanofi pipeline chart. MenQuadfi®, a quadrivalent ACWY vaccine, met all primary and secondary endpoints, demonstrating the induced superior immune responses to serogroup C based on geometric mean antibody titers (GMTs) compared to NeisVac-C (monovalent C vaccine) - standard-of-care vaccine- , in healthy toddlers. The data also showed superior immune responses to serogroup C based on seroprotection rates and GMTs compared to Nimenrix® (quadrivalent ACWY vaccine) in this population. MenQuadfi is approved in Europe for use as a single dose in individuals 12 months of age and older for the prevention of invasive meningococcal ACWY disease. In the US it is licensed for the prevention of invasive meningococcal disease in individuals 2 years of age and older. Phase 2 Positive results from a Phase 2a study evaluating the safety and efficacy of amlitelimab in patients with moderate-to-severe atopic dermatitis, were presented as a late-breaker at the European Academy of Dermatology and Venerology (EADV) 2021 Virtual Congress. Amlitelimab, formerly known as KY1005, is a human monoclonal antibody targeting immune system regulator OX40-Ligand At week 16, the data demonstrated that when dosed intravenously every four weeks an 80% improvement in average EASI from baseline for the low dose and a 70% improvement in average EASI from baseline for the high dose was achieved, compared to 49% for the placebo group indicating a consistent pharmacological effect of blocking OX40-L. A Phase 2b dose ranging study is about to start, including lower doses and subcutaneous injection. SAR444727 (formerly known as PRN473), a topically administered BTK inhibitor, entered Phase 2a study, evaluating safety, tolerability, and pharmacokinetics in patients with mild-to-moderate atopic dermatitis. Data of tolebrutinib, an oral brain penetrant BTK inhibitor, were published in Lancet Neurology. The Phase 2b trial showed both safety and efficacy in relapsing multiple sclerosis. The treatment led to a dose-dependent reduction in new gadolinium-enhancing lesions, leading to a reduction of acute inflammation, while the drug was well tolerated. The phase 3 clinical trials in patients with relapsing and progressive forms of multiple sclerosis are currently enrolling. SAR444245 (formerly known as THOR707), a novel non-alpha IL-2, entered a phase 2 basket trial in combination with Libtayo® for the treatment of various advanced skin cancers. A phase 2 study cohort evaluating safety and efficacy of Sarclisa® in combination with atezolizumab in 1L mCRC was terminated. A phase 2 study evaluating the safety and efficacy of Sarclisa®, in Adults with Warm Autoimmune Hemolytic Anemia (wAIHA) was initiated. The phase 1/2 study of SP0254, an mRNA-based COVID-19 vaccine candidate, delivered positive interim results confirming the company’s platform robust capabilities and strategy in mRNA. Taking into account public health needs and given sufficient mRNA COVID-19 vaccines supply can be expected going forward, the development of SP0254 will not be further continued. Phase 1 SAR443216, an anti-CD3xCD28xHER2 trispecific antibody, entered phase 1 study for the treatment of metastatic gastric cancers with HER2 low expression or HER2 mutation. SAR443726, a novel IL13/OX40L nanobody entered a first-in-human, three-part, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult participants and in adult participants with moderate-to-severeatopic dermatitis. Sangamo and Sanofi are continuing to advance the zinc finger genome editing program (SAR445136, formerly known as BIVV003) for sickle cell disease. The companies recently obtained manufacturing requirements guidance from FDA in preparation for further clinical studies and expect to share preliminary data from the sickle cell program at an upcoming meeting. The parties agreed to terminate the program addressing transfusion-dependent β-thalassemia (ST400) while focusing resources on the sickle cell disease indication. Acquisitions On September 14, Sanofi completed the acquisition of Translate Bio, acquiring all of their outstanding shares for $38.00 per share in cash, representing a total equity value of approximately $3.2 billion. Translate Bio is a clinical-stage mRNA therapeutics company, having already signed a collaboration with Sanofi in 2018, to develop mRNA vaccines which was further expanded in 2020 to broadly address current and future infectious diseases. The acquisition builds on Sanofi’s establishment of a first-of-its kind vaccines mRNA Center of Excellence. On September 8, Sanofi entered into a definitive agreement to acquire Kadmon Holdings4 for $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion. The acquisition supports Sanofi’s strategy to continue to grow its General Medicines core assets and will immediately add Rezurock™(belumosudil) to its transplant portfolio. This latter, a Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, has been 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. An update of the R&D pipeline as of September 30, 2021, is available on our website. Progress on implementation of the Corporate Social Responsibility strategy Sanofi is accelerating its efforts to address climate change and intends to achieve net zero5 greenhouse gas (GHG) emissions across all operations (scope 1 & 2) and the entire value chain (scope 3) by 2050. In alignment with the 1.5°C pathway, this new commitment will be building on years of work to reduce the environmental footprint of its products and activities through its Planet Mobilization program. In this journey, the company has also set an interim target to reach by 2030 carbon neutrality6 across all scopes of emissions, 20 years ahead of its previous commitment made in 2015 after the COP21 and the Paris Agreement. Sanofi’s carbon footprint (scope 1 and 2) has decreased by –27% between 2015 and 2020. As per today, renewable electricity represents 50% of total electricity consumption, on track to reach 100% of renewable electricity supply in 2030, and its RE1007 commitment. As a result of an eco-driving policy and the renewal of the car fleet, the eco fleet represents 22% of total car fleet today with the objective to reach 100% by 2030. The company will continue to report on progress annually to ensure its efforts are on track. Finally, in the run-up to the 26th UN Climate Change Conference of the Parties (COP26), Sanofi has joined the UN’s 'Race to Zero' initiative. This global campaign mobilizes cities, regions, investors and 20% of the major companies by revenue committing to net zero carbon emissions by 2050. The COP26 will take place in Glasgow (UK) from October 31 until November 12, 2021. In recognition of Sanofi’ ESG strategy implementation, Sanofi is ranked #1 in the European pharmaceutical sector in the latest international ESG ranking issued by Vigeo Eiris (V.E), published late August 2021. V.E, which is part of Moody’s ESG Solutions, is an independent international ESG rating agency. Its assessment is based on information covering 28 areas of interest ranging from climate change, health, safety, and environmental issues to human and labor rights. VE's ESG scores measure the degree to which companies factor and manage material Environmental, Social and Governance factors. Across the pharmaceutical sector globally, Sanofi scored of 62/100 points moving up from its fourth place in the ranking one year ago. Embedded in Sanofi's long-term Play to Win strategy, the company’s ESG strategy is based on four essential pillars. Sanofi Global Health, a newly formed nonprofit unit within the company, will provide thirty of Sanofi's medicines across a wide range of therapeutic areas to patients in 40 of the lowest income countries. Sanofi Global Health will also fund the training of healthcare professionals and the development of sustainable care systems. Sanofi continues its efforts to fight polio and sleeping sickness, two of its historical programs that address global health issues. Sanofi is the only pharmaceutical company that keeps developing and supplying treatments for sleeping sickness. It has committed itself alongside the WHO to eliminate this neglected tropical disease in humans by 2030. Over the years, Sanofi has supplied billions of polio vaccine doses, including hundreds of millions of donated doses to support the global polio eradication effort. To contribute to better resource conservation, Sanofi plans to remove all pre-formed plastic packaging (blister packs) for its vaccines by 2027. In addition, the company is committed to ecodesigning all its new products by 2025. To reduce its greenhouse gas emissions by 55% by 2030, all Sanofi sites will use 100% renewable electricity and the company has set a target of a carbon-neutral car fleet, both by 2030. As a global company, Sanofi is committed to ensuring that its leaders reflect the communities and patients it serves. The company is committed to continue fostering an organization where all employees have equal opportunities to reach positions of responsibility within the company. Sanofi also keeps its commitment to making a strong contribution to current global public health priorities, with the supply of half a billion doses of authorized vaccines. Sanofi is the only company leveraging its worldwide manufacturing capacity and expertise for the supply of three different authorized COVID-19 vaccines from BioNTech / Pfizer, Moderna, and Johnson & Johnson. Manufacturing teams on three industrial sites of the company in France, Germany and the U.S. are mobilized, with 30 million doses released by end September. At the same time, Sanofi continues its efforts in the fight against the COVID-19 pandemic with its adjuvanted recombinant protein candidate vaccine, developed in partnership with GSK. In parallel to its ongoing Phase 3 efficacy and safety study, Sanofi has expanded its development program to include a study of the vaccine as a potentially broadly protective booster to address evolving public health needs. First data readout is expected before year-end. 2021 third-quarter and the first nine months financial results Business Net Income8 In the third quarter of 2021, Sanofi generated net sales of €10,432 million, an increase of 10.1% (on a reported basis and at CER). In the first nine months, net sales were €27,767 million up 4.2% (up 8.2% at CER). Third-quarter other revenues decreased 0.7% (up 0.2% at CER) to €397 million, reflecting decreased VaxServe sales of non-Sanofi products (€336 million, down 5.3% at CER). In the first nine months, other revenues increased 2.0% (up 8.1% at CER) to €993 million, including higher VaxServe sales of non-Sanofi products (€790 million, up 0.8% at CER). Third-quarter Gross Profit increased 13.0% (on a reported basis and at CER) to €7,591 million. The gross margin ratio increased 1.9 percentage points to 72.8% versus the third quarter of 2020. This improvement mainly reflected efficiency gains in Industrial Affairs, favorable impact of growing weight of Specialty Care (the Pharmaceuticals gross margin ratio improved from 73.5% to 75.2%), positive product mix of Vaccines (Vaccines gross margin ratio increased 3.7 percentage point to 72.0% which more than offset lower CHC gross margin ratio (64.7% versus 66.6%). In the first nine months, the gross margin ratio increased 0.9 percentage point to 72.0% (72.1% at CER). Research and Development (R&D) expenses increased 9.2% (up 9.3% at CER) to €1,443 million in the third quarter, reflecting increase in priority assets development and early pipeline as well as recent acquisitions partly offset by efficiencies. In the first nine months, R&D expenses increased 2.3% to €4,106 million and were up 4.9% at CER as increased investment behind key assets were partly offset by the benefits of terminating diabetes and cardiovascular care related projects recorded in 2020. Third-quarter selling general and administrative expenses (SG&A) increased 3.9% to €2,267 million. At CER, SG&A expenses were up 3.6%, reflecting increased commercial investments in Specialty Care growth drivers which were partially offset by continued streamlining of General and Administrative expenses (G&A). In the third quarter, the ratio of SG&A to sales decreased 1.3 percentage points to 21.7% compared to the prior year. In the first nine months, SG&A expenses increased 0.1% to €6,797 million (up 3.6% at CER). In the first nine months, ratio of SG&A to sales was 1.0 percentage point lower at 24.5% compared to the prior year. Third-quarter operating expenses were €3,710 million, an increase of 5.9% and 5.7% at CER. In the first nine months operating expenses were €10,903 million, an increase of 0.9% and an increase of 4.1% at CER. Third-quarter other current operating income net of expenses was -€289 million versus -€182 million in the third quarter of 2020. Other current operating income net of expenses included an expense of €399 million (versus an expense of €229 million in the third quarter of 2020) 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 nine months, other current operating income net of expenses was -€589 million versus -€437 million in the same period of 2020. The share of profit from associates was -€5 million versus €1 million in Q3 2020 and included the share of U.S profit related to VaxelisTM. Third-quarter business operating income8 (BOI) increased 17.5% to €3,558 million. At CER, BOI increased 17.3%. The ratio of BOI to net sales was 34.1% versus 31.9% in Q3 2020 reflecting seasonal contribution of flu vaccines, gross margin ratio improvement as well as SG&A ratio improvement. In the first nine months, business operating income was €8,461 million, up 9.7% (up 15.0% at CER) and the ratio of business operating income to net sales increased 1.6 percentage points to 30.5% (30.8% at CER). Net financial expenses were €85 million in the third quarter versus €76 million in the same period of 2020. Third-quarter and the first-nine months 2021 effective tax rate was 21.0% versus 22% in the prior year. Sanofi expects its effective tax rate to be around 21% in 2021, everything being equal in the U.S. Third-quarter business net income8 increased 19.0% to €2,736 million and increased 18.8% at CER. The ratio of business net income to net sales increased 1.9 percentages points to 26.2% versus the third quarter of 2020. In the first nine months, business net income increased 11.4% to €6,484 million and increased 16.9% at CER. The ratio of business net income to net sales increased 1.6 percentage points to 23.4% versus the same period of 2020. In the third quarter of 2021, business earnings per share8 (EPS) was €2.18, up 19.1% on a reported basis (and at CER). The average number of shares outstanding was 1,254.5 million versus 1,255.7 million in third quarter 2020. In the first nine months of 2021, business earnings per share8 was €5.18, up 11.6% on a reported basis and up 17.2% at CER. The average number of shares outstanding was 1,251.7 million in the first nine months of 2021 versus 1,253.0 million in the first nine months 2020. Reconciliation of IFRS net income reported to business net income (see Appendix 4) In the first nine months of 2021, the IFRS net income was €5,093 million. The main items excluded from the business net income were: An amortization charge of €1,160 million related to fair value remeasurement on intangible assets of acquired companies (primarily Genzyme: €380 million, Bioverativ: €238 million, Boehringer Ingelheim CHC business: €148 million and Ablynx: €126 million) and to acquired intangible assets (licenses/products: €70 million). These items have no cash impact on the Company. An impairment of intangible assets of €177 million mainly related to sutimlimab (termination of ITP). Restructuring costs and similar items of €494 million related to streamlining initiatives. A €440 million tax effect arising from the items listed above, mainly comprising €320 million of deferred taxes generated by amortization and impairments of intangible assets and €121 million associated with restructuring costs and similar items (see Appendix 4). Capital Allocation In the first nine months of 2021, free cash flow before restructuring, acquisitions and disposals increased by 21.0% to €6,968 million, after net changes in working capital (+€218 million) and capital expenditures (-€953 million). After acquisitions9 (-€1,093 million of which Kiadis -€319 million, Tidal Therapeutics -€135 millions), proceeds from disposals9 (+€461 million), and payments related to restructuring and similar items (-€781 million), free cash flow10 increased 1.9% to €5,555 million, reflecting recent acquisitions to strengthen the long-term pipeline and less proceeds compared to last year as Seprafilm was divested in Q1 2020 (€311 million). After the acquisition of Translate Bio (-€ 2,397 million) and Kymab (-€922 million) and the dividend paid by Sanofi (-€4,008 million), net debt increased from €8,790 million at December 31, 2020 to €10,427 million at September 30, 2021 (amount net of €9,785 million cash and cash equivalents). Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, risks related to Sanofi’s ability to complete the proposed transaction with Kadmon Holdings, Inc. on the proposed terms or on the proposed timeline, including the receipt of required regulatory approvals, the possibility that competing offers will be made, other risks associated with executing business combination transactions, as well as other risks related to Sanofi’s business, including the ability to grow sales and revenues from existing products and to develop, commercialize or market new products, competition, 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, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Appendices List of appendices Appendix 1: 2021 third-quarter and first nine months sales by GBU, franchise, geographic region and product Appendix 2: 2021 third-quarter and first nine months business net income statement Appendix 3: 2021 third-quarter and first nine months consolidated income statement Appendix 4: Reconciliation of IFRS net income reported to business net income Appendix 5: Change in net debt Appendix 6: Currency sensitivity Appendix 7: Definitions of non-GAAP financial indicators Investor Relations: (+) 33 1 53 77 45 45 - E-mail: IR@sanofi.com - Media Relations: (+) 33 1 53 77 46 46 - E-mail: MR@sanofi.com Website: Appendix 1: 2021 third-quarter net sales by GBU, franchise, geographic region and product Q3 2021 (€ million) Total Sales % CER % reported United States % CER Europe % CER Rest of the world % CER Dupixent 1,410 54.6 % 53.6 % 1,061 47.7 % 173 78.4 % 176 82.3 % Aubagio 483 -3.8 % -4.4 % 328 -6.8 % 122 1.7 % 33 10.0 % Lemtrada 20 -16.7 % -16.7 % 9 -35.7 % 7 -14.3 % 4 66.7 % Kevzara 83 42.4 % 40.7 % 49 75.0 % 24 33.3 % 10 -15.4 % Neurology & Immunology 586 0.3 % -0.3 % 386 -2.0 % 153 4.8 % 47 6.5 % Cerezyme 159 0.6 % -1.9 % 45 4.7 % 59 -4.8 % 55 3.5 % Cerdelga 64 5.0 % 6.7 % 33 0.0 % 26 13.0 % 5 0.0 % Myozyme 266 10.4 % 10.4 % 103 13.2 % 105 6.1 % 58 13.5 % Fabrazyme 209 3.4 % 2.5 % 101 0.0 % 53 3.9 % 55 9.8 % Aldurazyme 57 5.5 % 3.6 % 13 7.7 % 20 0.0 % 24 9.1 % Rare Disease 779 5.4 % 4.6 % 296 5.7 % 264 3.5 % 219 7.2 % Jevtana 105 -20.9 % -21.6 % 63 1.6 % 20 -58.3 % 22 -4.3 % Fasturtec 37 -9.5 % -11.9 % 22 -17.9 % 12 9.1 % 3 0.0 % Libtayo 35 61.9 % 66.7 % — 0.0 % 28 47.4 % 7 200.0 % Sarclisa 48 276.9 % 269.2 % 18 111.1 % 17 750.0 % 13 550.0 % Oncology 225 8.1 % 7.1 % 103 6.0 % 77 -3.8 % 45 46.7 % Alprolix 101 -6.4 % -7.3 % 83 5.0 % — 0.0 % 18 -37.9 % Eloctate 144 -4.6 % -5.3 % 111 3.7 % — 0.0 % 33 -25.0 % Cablivi 42 32.3 % 35.5 % 19 -9.5 % 22 120.0 % 1 0.0 % Rare Blood Disorder 287 -1.4 % -1.7 % 213 2.9 % 22 120.0 % 52 -30.1 % Specialty Care 3,287 20.2 % 19.4 % 2,059 21.4 % 689 17.2 % 539 19.6 % Lantus 622 -5.9 % -5.3 % 199 -20.9 % 113 -11.1 % 310 10.1 % Toujeo 239 11.1 % 10.6 % 72 9.1 % 96 6.7 % 71 20.0 % Soliqua/iGlarLixi 51 27.5 % 27.5 % 30 25.0 % 7 16.7 % 14 40.0 % 0thers Diabetes 211 -6.6 % -7.0 % 39 -23.1 % 61 -3.2 % 111 -0.9 % Diabetes 1,123 -1.7 % -1.5 % 340 -13.4 % 277 -3.2 % 506 9.3 % Lovenox 383 4.4 % 4.9 % 9 14.3 % 166 -1.8 % 208 9.5 % Plavix 222 6.3 % 8.3 % 2 -33.3 % 28 -6.9 % 192 9.2 % Multaq 79 0.0 % 0.0 % 70 1.4 % 5 -16.7 % 4 0.0 % Praluent 59 18.0 % 18.0 % — -100.0 % 41 36.7 % 18 200.0 % Aprovel 107 -21.8 % -19.5 % 4 -42.9 % 19 -13.0 % 84 -22.3 % Mozobil 60 7.1 % 7.1 % 33 3.1 % 16 7.1 % 11 20.0 % Thymoglobulin 91 4.6 % 4.6 % 52 1.9 % 9 0.0 % 30 11.5 % Generics 172 -10.9 % -10.9 % 26 -40.5 % 3 0.0 % 143 -2.7 % Others 1,064 -4.0 % -2.9 % 96 -10.2 % 335 -9.2 % 633 0.2 % Cardiovascular & Established Rx Products 2,237 -2.1 % -1.2 % 292 -12.5 % 622 -4.8 % 1,323 2.0 % Industrial Sales 208 2.5 % 2.0 % 9 -60.0 % 186 13.4 % 13 -25.0 % General Medicines 3,568 -1.7 % -1.1 % 641 -14.3 % 1,085 -1.6 % 1,842 3.6 % Pharmaceuticals 6,855 7.8 % 7.8 % 2,700 10.5 % 1,774 4.9 % 2,381 6.9 % Polio / Pertussis / Hib 563 1.8 % 1.8 % 124 6.8 % 79 -11.2 % 360 3.5 % Adult Booster Vaccines 158 4.6 % 4.6 % 105 14.1 % 36 -7.7 % 17 -15.0 % Meningitis / Pneumonia 253 18.7 % 18.2 % 218 19.7 % — 0.0 % 35 12.9 % Influenza Vaccines 1,339 25.5 % 25.7 % 982 18.1 % 247 87.8 % 110 5.9 % Travel and Other Endemic Vaccines 82 16.9 % 15.5 % 34 100.0 % 12 200.0 % 36 -26.0 % Vaccines 2,422 16.5 % 16.6 % 1,488 18.5 % 374 41.8 % 560 0.0 % Allergy 142 17.4 % 17.4 % 92 13.6 % 8 -11.1 % 42 35.5 % Cough, Cold and Flu 94 4.4 % 4.4 % — 0.0 % 45 -10.2 % 49 22.0 % Pain Care 290 18.2 % 17.4 % 53 23.3 % 127 9.5 % 110 27.3 % Digestive Wellness 282 16.0 % 16.0 % 29 16.0 % 97 9.0 % 156 20.9 % Physical Wellness 85 -7.7 % -6.6 % — 0.0 % 7 0.0 % 78 -8.3 % Mental Wellness 53 8.2 % 8.2 % 11 0.0 % 23 4.3 % 19 20.0 % Personal Care 135 5.4 % 4.7 % 101 9.7 % 1 0.0 % 33 -8.3 % Non-Core / Others 74 4.2 % 4.2 % 3 -233.3 % 27 -16.1 % 44 2.3 % Consumer Healthcare 1,155 11.1 % 11.0 % 289 16.4 % 335 3.1 % 531 13.9 % Company 10,432 10.1 % 10.1 % 4,477 13.4 % 2,483 8.9 % 3,472 6.7 % Appendix 1: 2021 first nine months net sales by GBU, franchise, geographic region and product First 9M 2021 (€ million) Total Sales % CER % reported United States % CER Europe % CER Rest of the world % CER Dupixent 3,700 52.5 % 45.0 % 2,801 46.3 % 462 70.1 % 437 85.0 % Aubagio 1,477 -1.7 % -6.1 % 994 -6.2 % 386 10.0 % 97 8.7 % Lemtrada 63 -27.2 % -31.5 % 29 -36.7 % 18 -32.0 % 16 5.6 % Kevzara 196 15.3 % 11.4 % 99 13.0 % 65 18.2 % 32 17.2 % Neurology & Immunology 1,736 -1.4 % -5.7 % 1,122 -6.0 % 469 8.6 % 145 10.1 % Cerezyme 502 1.1 % -5.3 % 128 2.3 % 183 -2.1 % 191 3.3 % Cerdelga 187 10.9 % 6.9 % 97 7.2 % 77 13.2 % 13 30.0 % Myozyme 749 8.4 % 5.0 % 283 11.5 % 305 4.5 % 161 10.5 % Fabrazyme 621 5.7 % 0.6 % 291 0.6 % 164 10.1 % 166 11.3 % Aldurazyme 180 7.3 % 1.7 % 39 7.7 % 63 6.8 % 78 7.6 % Rare Disease 2,308 6.1 % 1.4 % 839 5.6 % 794 5.2 % 675 8.0 % Jevtana 345 -10.9 % -14.8 % 182 4.3 % 95 -32.1 % 68 -8.9 % Fasturtec 111 1.8 % -2.6 % 65 -4.1 % 34 9.7 % 12 20.0 % Libtayo 94 95.8 % 95.8 % — 0.0 % 76 76.7 % 18 260.0 % Sarclisa 122 605.6 % 577.8 % 46 250.0 % 44 2100.0 % 32 1600.0 % Oncology 672 19.3 % 14.9 % 293 14.7 % 249 15.3 % 130 41.7 % Alprolix 301 -4.8 % -10.1 % 245 8.3 % — 0.0 % 56 -38.3 % Eloctate 422 -7.3 % -12.4 % 327 1.8 % — 0.0 % 95 -29.3 % Cablivi 126 56.6 % 51.8 % 62 22.2 % 62 113.8 % 2 0.0 % Rare Blood Disorder 849 -0.4 % -5.7 % 634 6.0 % 62 113.8 % 153 -32.1 % Specialty Care 9,265 19.2 % 13.6 % 5,689 19.6 % 2,036 19.5 % 1,540 17.4 % Lantus 1,911 -4.1 % -7.9 % 628 -7.8 % 359 -11.8 % 924 2.1 % Toujeo 739 7.9 % 3.8 % 192 -2.4 % 291 4.7 % 256 21.3 % Soliqua/iGlarLixi 141 28.7 % 22.6 % 83 23.9 % 21 23.5 % 37 44.4 % 0thers Diabetes 653 -3.7 % -7.6 % 126 -11.2 % 191 -3.5 % 336 -0.6 % Diabetes 3,444 -0.6 % -4.5 % 1,029 -5.3 % 862 -4.2 % 1,553 5.0 % Lovenox 1,151 19.1 % 15.7 % 24 13.6 % 534 15.0 % 593 23.1 % Plavix 707 1.0 % -0.8 % 7 0.0 % 88 -7.4 % 612 2.3 % Multaq 230 4.3 % -1.3 % 202 4.9 % 17 -5.6 % 11 10.0 % Praluent 163 -15.8 % -16.8 % 5 -92.7 % 116 34.9 % 42 53.6 % Aprovel 307 -29.4 % -30.1 % 7 -63.2 % 66 -11.8 % 234 -31.4 % Mozobil 170 13.5 % 9.7 % 93 8.9 % 45 10.0 % 32 36.0 % Thymoglobulin 263 16.1 % 11.4 % 153 16.4 % 25 13.6 % 85 16.2 % Generics 566 -0.3 % -7.8 % 96 -12.8 % 7 0.0 % 463 2.7 % Others 3,197 -5.0 % -7.6 % 254 -14.0 % 1,032 -11.2 % 1,911 0.1 % Cardiovascular & Established Rx Products 6,754 -1.0 % -4.1 % 841 -10.3 % 1,930 -2.0 % 3,983 1.8 % Industrial Sales 588 4.2 % 2.1 % 33 -32.7 % 521 15.8 % 34 -45.6 % General Medicines 10,786 -0.6 % -3.9 % 1,903 -8.2 % 3,313 -0.2 % 5,570 2.1 % Pharmaceuticals 20,051 7.7 % 3.5 % 7,592 11.1 % 5,349 6.5 % 7,110 5.1 % Polio / Pertussis / Hib 1,616 3.1 % 0.2 % 365 29.3 % 224 -10.4 % 1,027 -1.1 % Adult Booster Vaccines 364 8.7 % 5.8 % 218 21.3 % 102 -9.7 % 44 2.3 % Meningitis / Pneumonia 567 36.2 % 30.6 % 425 43.1 % 1 0.0 % 141 18.9 % Influenza Vaccines 1,535 23.9 % 23.4 % 982 16.3 % 265 94.1 % 288 11.8 % Travel and Other Endemic Vaccines 215 -1.3 % -4.4 % 70 23.3 % 25 -40.5 % 120 0.0 % Vaccines 4,359 13.8 % 11.4 % 2,114 24.3 % 618 13.6 % 1,627 2.6 % Allergy 485 2.2 % -3.4 % 292 5.8 % 42 -6.7 % 151 -1.9 % Cough, Cold and Flu 204 -30.9 % -32.2 % — 0.0 % 91 -42.4 % 113 -18.2 % Pain Care 818 7.3 % 2.8 % 144 8.5 % 377 5.3 % 297 9.2 % Digestive Wellness 855 21.8 % 16.5 % 90 57.4 % 297 6.4 % 468 27.3 % Physical Wellness 244 -5.7 % -7.9 % — 0.0 % 20 5.3 % 224 -6.5 % Mental Wellness 160 16.8 % 11.9 % 34 5.9 % 78 15.9 % 48 27.5 % Personal Care 387 2.8 % -3.0 % 292 3.3 % 3 50.0 % 92 0.0 % Non-Core / Others 204 -5.8 % -9.3 % 7 700.0 % 80 -26.2 % 117 6.8 % Consumer Healthcare 3,357 4.2 % -0.2 % 859 10.0 % 988 -4.6 % 1,510 7.2 % Company 27,767 8.2 % 4.2 % 10,565 13.4 % 6,955 5.3 % 10,247 5.0 % Appendix 2: Business net income statement Third Quarter 2021 Pharmaceuticals Vaccines Consumer Healthcare Other(1) Total Group € million Q3 2021 Q3 2020 Change Q3 2021 Q3 2020 Change Q3 2021 Q3 2020 Change Q3 2021 Q3 2020 Change Q3 2021 Q3 2020 Change Net sales 6,855 6,361 7.8% 2,422 2,077 16.6% 1,155 1,041 11.0% — — —% 10,432 9,479 10.1% Other revenues 44 28 57.1% 339 359 -5.6% 14 13 7.7% — — —% 397 400 -0.7% Cost of Sales (1,744) (1,715) 1.7% (1,017) (1,018) -0.1% (422) (361) 16.9% (55) (65) -15.4% (3,238) (3,159) 2.5% As % of net sales (25.4)% (27.0)% (42.0)% (49.0)% (36.5)% (34.7)% (31.0)% (33.3)% Gross Profit 5,155 4,674 10.3% 1,744 1,418 23.0% 747 693 7.8% (55) (65) -15.4% 7,591 6,720 13.0% As % of net sales 75.2% 73.5% 72.0% 68.3% 64.7% 66.6% 72.8% 70.9% Research and development expenses (1,104) (980) 12.7% (185) (178) 3.9% (35) (37) -5.4% (119) (126) -5.6% (1,443) (1,321) 9.2% As % of net sales (16.1)% (15.4)% (7.6)% (8.6)% (3.0)% (3.6)% (13.8)% (13.9)% Selling and general expenses (1,281) (1,151) 11.3% (198) (193) 2.6% (327) (330) -0.9% (461) (508) -9.3% (2,267) (2,182) 3.9% As % of net sales (18.7)% (18.1)% (8.2)% (9.3)% (28.3)% (31.7)% (21.7)% (23.0)% Other current operating income/expenses (329) (190) 2 (2) 77 (3) (39) 13 (289) (182) Share of profit/loss of associates* and joint ventures (5) (1) (3) 2 3 — — — (5) 1 Net income attributable to non controlling interests (27) (8) (1) — (1) (1) — — (29) (9) Business operating income (2) 2,409 2,344 2.8% 1,359 1,047 29.8% 464 322 44.1% (674) (686) -1.7% 3,558 3,027 17.5% As % of net sales 35.1% 36.8% 56.1% 50.4% 40.2% 30.9% 34.1% 31.9% Financial income and expenses (85) (76) Income tax expenses (737) (652) Tax rate** 21.0% 22.0% Business net income 2,736 2,299 19.0% As % of net sales 26.2% 24.3% Business earnings / share(in euros)*** 2.18 1.83 19.1% * 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 1,254.5 million in the third quarter of 2021 and 1,255.7 million in the third quarter of 2020. (1) Other includes the cost of global support functions (Finance, Human Resources, Information Solution & Technologies, Sanofi Business Services, etc…). (2) The 2020 items have been represented in order to take into account the reallocation of certain expenses, in particular the IT costs related to the new Digital organization, which were previously allocated to the Pharmaceuticals, Vaccines and Consumer Health Care segments and are now accounted for under "Other". 9 months 2021 Pharmaceuticals Vaccines Consumer Healthcare Other(1) Total Group € million 9M 2021 9M 2020 Change 9M 2021 9M 2020 Change 9M 2021 9M 2020 Change 9M 2021 9M 2020 Change 9M 2021 9M 2020 Change Net sales 20,051 19,381 3.5% 4,359 3,913 11.4% 3,357 3,365 (0.2)% — — — 27,767 26,659 4.2% Other revenues 152 98 55.1% 800 833 (4.0)% 41 43 (4.7)% — — — 993 974 2.0% Cost of Sales (5,147) (5,121) 0.5% (2,271) (2,194) 3.5% (1,175) (1,142) 2.9% (186) (209) (11.0)% (8,779) (8,666) 1.3% As % of net sales (25.7)% (26.4)% (52.1)% (56.1)% (35.0)% (33.9)% —% (31.6)% (32.5)% Gross Profit 15,056 14,358 4.9% 2,888 2,552 13.2% 2,223 2,266 (1.9)% (186) (209) (11.0)% 19,981 18,967 5.3% As % of net sales 75.1% 74.1% 66.3% 65.2% 66.2% 67.3% — 72.0% 71.1% Research and development expenses (3,145) (3,045) 3.3% (501) (497) 0.8% (104) (106) (1.9)% (356) (365) (2.5)% (4,106) (4,013) 2.3% As % of net sales (15.7)% (15.7)% (11.5)% (12.7)% (3.1)% (3.2)% — (14.8)% (15.1)% Selling and general expenses (3,761) (3,539) 6.3% (557) (562) (0.9)% (1,027) (1,074) (4.4)% (1,452) (1,614) (10.0)% (6,797) (6,789) 0.1% As % of net sales (18.8)% (18.3)% (12.8)% (14.4)% (30.6)% (31.9)% — (24.5)% (25.5)% Other current operating income/expenses (795) (340) 123 2 100 18 (17) (117) (589) (437) Share of profit/loss of associates* and joint ventures 8 3 5 2 8 7 — — 21 12 Net income attributable to non controlling interests (43) (25) (1) — (5) (5) — — (49) (30) Business operating income (2) 7,320 7,412 (1.2)% 1,957 1,497 30.7% 1,195 1,106 8.0% (2,011) (2,305) (12.8)% 8,461 7,710 9.7% As % of net sales 36.5% 38.2% 44.9% 38.3% 35.6% 32.9% 30.5% 28.9% Financial income and expenses (246) (243) Income tax expenses (1,731) (1,647) Tax rate** 21.0% 22.0% Business net income 6,484 5,820 11.4% As % of net sales 23.4% 21.8% Business earnings / share(in euros)*** 5.18 4.64 11.6% * 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 1,251.7 million in the first nine months of 2021 and 1,253 million in the first nine months of 2020. (1) Other includes the cost of global support functions (Finance, Human Resources, Information Solution & Technologies, Sanofi Business Services, etc…). (2) The 2020 items have been represented in order to take into account the reallocation of certain expenses, in particular the IT costs related to the new Digital organization, which were previously allocated to the Pharmaceuticals, Vaccines and Consumer Health Care segments and are now accounted for under "Other". Appendix 3: Consolidated income statements € million Q3 2021 Q3 2020 9M 2021 9M 2020 Net sales 10,432 9,479 27,767 26,659 Other revenues 397 400 993 974 Cost of sales (3,238) (3,176) (8,779) (8,719) Gross profit 7,591 6,703 19,981 18,914 Research and development expenses (1,443) (1,321) (4,106) (4,013) Selling and general expenses (2,267) (2,182) (6,797) (6,789) Other operating income 259 242 668 523 Other operating expenses (548) (424) (1,257) (1,117) Amortization of intangible assets (385) (404) (1,160) (1,287) Impairment of intangible assets (1) 1 (2) (177) (325) Fair value remeasurement of contingent consideration 5 22 1 76 Restructuring costs and similar items (167) (110) (494) (868) Other gains and losses, and litigation (2) (4) — (4) 136 Gain on Regeneron investment as result of transaction completed on May 29th, 2020 (3) — — — 7,382 Operating income 3,042 2,524 6,655 12,632 Financial expenses (87) (91) (276) (289) Financial income 2 15 30 46 Income before tax and associates and joint ventures 2,957 2,448 6,409 12,389 Income tax expense (609) (490) (1,291) (1,484) Share of profit/(loss) of associates and joint ventures (5) 1 21 355 Net income 2,343 1,959 5,139 11,260 Net income attributable to non-controlling interests 26 7 46 27 Net income attributable to equity holders of Sanofi 2,317 1,952 5,093 11,233 Average number of shares outstanding (million) 1,254.5 1,255.7 1,251.7 1,253.0 IFRS Earnings per share (in euros) 1.85 1.55 4.07 8.96 (1) In 2021 and 2020, mainly related to Sutimlimab impairments. (2) In 2020, includes mainly the gain on the sale of operations related to the Seprafilm product to Baxter. (3) In 2020, this line includes the pre-tax income from the sale of Regeneron shares following the public offer for sale and Regeneron's repurchase on May 29, 2020. This amount includes the gain related to the remeasurement at fair value of the 400,000 retained shares that could be used to finance the R&D collaboration under the letter of agreement dated 2018. Appendix 4: Reconciliation of Net income attributable to equity holders of Sanofi to Business net income € million Q3 2021 Q3 2020 9M 2021 9M 2020 Net income attributable to equity holders of Sanofi 2,317 1,952 5,093 11,233 Amortization of intangible assets (1) 385 404 1,160 1,287 Impairment of intangible assets (2) (1) 2 177 325 Fair value remeasurement of contingent consideration (5) (22) (1) (76) Expenses arising from the impact of acquisitions on inventories — 17 — 53 Restructuring costs and similar items 167 110 494 868 Other gains and losses, and litigation (3) 4 — 4 (136) Gain on sale of Regeneron shares on May 29, 2020 (4) — — — (7,225) Tax effect of the items listed above: (129) (162) (440) (163) Amortization and impairment of intangible assets (90) (122) (320) (424) Fair value remeasurement of contingent consideration (1) (1) 2 1 Expenses arising from the impact of acquisitions on inventories — (3) — (8) Restructuring costs and similar items (37) (29) (121) (261) Gain on sale of Regeneron shares on May 29, 2020 — — — 475 Other tax effects (1) (7) (1) 54 Share of items listed above attributable to non-controlling interests (2) (2) (3) (3) Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures — — — (30) Effect of discontinuation of use of equity method for Regeneron investment (5) — — — (313) Business net income 2,736 2,299 6,484 5,820 IFRS earnings per share (6) (in euros) 1.85 1.55 4.07 8.96 (1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €361 million in the third quarter of 2021 and €383 million in the third quarter of 2020. (2) In 2021 and 2020, mainly related to Sutimlimab impairments. (3) In 2020, includes mainly the gain on the sale of operations related to the Seprafilm product to Baxter. (4) This line includes the result of the sale of 13 million of Regeneron’s shares as part of the public offering and of the 9.8 million of its shares repurchased by Regeneron. The amount does not include the gain related to the remeasurement at fair value at this date of the 400,000 retained shares. (5) Our non-GAAP indicator (Business Net Income) does not include the share of income related to equity accounting from Regeneron since it ceased to be an associate on May 29, 2020. As a result, this line reflects that exclusion up to this date. (6) Q3: Based on an average number of shares outstanding of 1,254.5 million in the third quarter of 2021 and 1,255.7 million in the third quarter of 2020. 9M : Based on an average number of shares outstanding of 1,251.7 million in the first nine months of 2021 and 1,253 million in the first nine months of 2020. Appendix 5: Change in net debt € million 9M 2021 9M 2020 (1) Business net income 6,484 5,820 Depreciation & amortization & impairment of property, plant and equipment and software 1,102 1,125 Other items 117 592 Operating cash flow 7,703 7,537 Changes in Working Capital 218 (933) Acquisitions of property, plant and equipment and software (953) (847) Free cash flow before restructuring, acquisitions and disposals 6,968 5,757 Acquisitions of intangibles assets, investments and other long-term financial assets (2) (1,093) (447) Restructuring costs and similar items paid (781) (660) Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets net of taxes (2) 461 802 Free cash flow 5,555 5,452 Acquisitions of investments in consolidated undertakings including assumed debt (3) (3,385) (5,767) Proceeds from Sale of Regeneron Shares on May 29,2020 net of taxes — 10,332 Issuance of Sanofi shares 175 194 Acquisition of treasury shares (140) (361) Dividends paid to shareholders of Sanofi (4,008) (3,937) Other items 166 (450) Change in net debt (1,637) 5,463 Beginning of period 8,790 15,107 Closing of net debt 10,427 9,644 (1) Excluding any effect of equity method accounting for Regeneron investment for comparison purposes. (2) Free cash flow includes investments and divestments not exceeding a cap of €500 million per transaction (inclusive of all payments related to the transaction). (3) Includes transactions that are above a cap of €500 million per transaction (inclusive of all payments related to the transaction). Appendix 6: Currency sensitivity 2021 business EPS currency sensitivity Currency Variation Business EPS Sensitivity U.S. Dollar +0.05 USD/EUR -EUR 0.13 Japanese Yen +5 JPY/EUR -EUR 0.02 Chinese Yuan +0.2 CNY/EUR -EUR 0.02 Brazilian Real +0.4 BRL/EUR -EUR 0.01 Russian Ruble +10 RUB/EUR -EUR 0.02 Currency exposure on Q3 2021 sales Currency Q3 2021 US $ 43.8 % Euro € 20.1 % Chinese Yuan 7.1 % Japanese Yen 3.9 % Brazilian Real 1.7 % Canadian $ 1.6 % British Pound 1.5 % Mexican Peso 1.3 % Russian ruble 1.3 % South Korean won 1.1 % Others 16.6 % Currency average rates Q3 2020 Q3 2021 Change 9M 2020 9M 2021 Change €/$ 1.17 1.18 +0.8 % 1.12 1.20 +6.5 % €/Yen 124.05 129.79 +4.6 % 120.84 129.80 +7.4 % €/Yuan 8.09 7.63 -5.7 % 7.87 7.74 -1.60 % €/Real 6.29 6.16 -2.0 % 5.71 6.38 +11.8 % €/Ruble 86.28 86.60 +0.4 % 79.87 88.60 +10.9 % Appendix 7: Definitions of non-GAAP financial indicators Company sales at constant exchange rates (CER) When we refer to changes in our net sales “at constant exchange rates” (CER), this means that we exclude the effect of changes in exchange rates. We eliminate the effect of exchange rates by recalculating net sales for the relevant period at the exchange rates used for the previous period. Reconciliation of net sales to Company sales at constant exchange rates for the third quarter and In the first nine months 2021 € million Q3 2021 9M 2021 Net sales 10,432 27,767 Effect of exchange rates — (1,075) Company sales at constant exchange rates 10,432 28,842 Business net income Sanofi publishes a key non-GAAP indicator. Following the Regeneron shares transaction that was completed on May 29, 2020, the definition of the non-GAAP financial measure “Business net income” has been revised such that Share of profit/(loss) from investments accounted for using the equity method excludes the effects of applying the equity method to the investment in Regeneron. The comparative periods of 2019 presented have been restated to reflect that adjustment. Business net income is defined as net income attributable to equity holders of Sanofi excluding: amortization of intangible assets, impairment of intangible assets, fair value remeasurement of contingent consideration related to business combinations or to disposals, other impacts associated with acquisitions (including impacts of acquisitions on associates and joint ventures), restructuring costs and similar items(1), other gains and losses (including gains and losses on disposals of non-current assets(1)), costs or provisions associated with litigation(1), gain on Regeneron investment as a result of the transaction completed on May 29, 2020 (the amount does not include the gain related to the remeasurement at fair value at this date of the 400,000 retained shares), tax effects related to the items listed above as well as effects of major tax disputes, effect of equity method accounting for Regeneron investment (excluded from Business net income as a consequence of the sale of the entire equity investment in Regeneron (with the exception of 400,000 shares retained by Sanofi) on May 29th 2020, net income attributable to non-controlling interests related to the items listed above. (1) Reported in the line items Restructuring costsand similar items and Gains and losses on disposals, and litigation, which are defined in Notes B.19. and B.20. to our consolidated financial statements. Free cash flow Free cash flow is a non-GAAP financial indicator which is reviewed by our management, and which we believe provides useful information to measure the net cash generated from the Company’s operations that is available for strategic investments1 (net of divestments1), for debt repayment, and for capital return to shareholders. Free Cash Flow is determined from the Business Net Income adjusted for depreciation, amortization and impairment, share of profit/loss in associates and joint ventures net of dividends received, gains & losses on disposals, net change in provisions including pensions and other post-employment benefits, deferred taxes, share-based expense and other non-cash items. It comprises net changes in working capital, capital expenditures and other asset acquisitions2 net of disposal proceeds2, and payments related to restructuring and similar items. Free cash flow is not defined by IFRS and it is not a substitute measure for the IFRS aggregate net cash flows in operating activities. 1 Amount of the transaction above a cap of €500 million per transaction (inclusive of all payments related to the transaction). 2 Not exceeding a cap of €500 million per transaction (inclusive of all payments related to the transaction). 1See Appendix 7 for definitions of financial indicators. 2Sanofi has prioritized core assets in its General Medicines portfolio with differentiated and/or established profiles that have significant opportunity for growth in key markets. Core assets include Toujeo, Soliqua, Praluent, Multaq, Lovenox, Plavix and others for total sales of €5.6bn in 2020 3API and Drug Product manufacturing in Sanofi sites for third party 4 Announced on September 8, 2021; Subject to satisfaction or waiver of customary closing conditions, Sanofi expects to complete the acquisition in Q4 2021 5Net zero is achieved when company emissions of greenhouse gases to the atmosphere are balanced by removals elsewhere over a specified period. 6Carbon neutrality is achieved when company emissions of greenhouse gases to the atmosphere are balanced by reduction or avoidance elsewhere over a specified period. 7RE100 is a global initiative bringing together the world's most influential businesses committed to 100% renewable electricity 8See Appendix 3 for 2021 third-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. 9Not exceeding €500 million per transaction (inclusive of all payments related to the transaction). 10non-GAAP financial measure (definition in Appendix 7). Attachment Press Release Q3 2021

Gene TherapyFinancial StatementAntibodyOrphan DrugBreakthrough Therapy

08 Feb 2021

·www.beckershospitalreview.com

20 most expensive prescription drugs in 2021

Drug prices in the U.S. are about 256 percent higher than those in other countries, according to recent research. Below is a list of the 20 most expensive prescription drugs in the U.S., based on the official price their manufacture assigned to them, as compiled by prescription discount company GoodRx. This list excludes medications that must be administered by a healthcare practitioner. Zokinvy (Eiger BioPharmaceuticals): $86,040 Myalept (Aegerion Pharmaceuticals): $74,159 Mavenclad (EMD Serono): $60,371 Ravicti (Horizon Therapeutics): $57,998 Actimmune (Horizon Therapeutics): $55,310 Oxervate (Dompé): $48,498 Takhzyro (Takeda): $46,828 Juxtapid (Aegerion Pharmaceuticals): $46,502 Cinryze (Takeda): $45,465 Chenodal (Travere Therapeutics): $42,570 Gattex (Takeda): $41,664 H.P. Acthar (Mallinckrodt Pharmaceuticals): $39,864 Orladeyo (BioCryst Pharmaceuticals): $37,308 Tegsedi (Akcea Therapeutics): $35,638 Ayvakit (Blueprint Medicines): $33,568 Vitrakvi (Bayer Pharmaceuticals): $32,800 Qinlock (Decipera Pharmaceuticals): $32,000 Korlym (Corcept Therapeutics): $31,440 Cerdelga (Genzyme): $28,599 Idhifa (Celgene): $28,246

100 Deals associated with Eliglustat

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KEGG	Wiki	ATC	Drug Bank
D09894	Eliglustat	A16AX10	DB09039

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Gaucher Disease	Japan	Sanofi KK	26 Mar 2015
Gaucher Disease	Japan	Genzyme Corp.	26 Mar 2015
Gaucher Disease, Type 1	United States	Genzyme Corp.	19 Aug 2014

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Gaucher Disease, Type 3	Phase 3	France	Sanofi	11 Apr 2018
Gaucher Disease, Type 3	Phase 3	Canada	Sanofi	11 Apr 2018
Gaucher Disease, Type 3	Phase 3	Sweden	Sanofi	11 Apr 2018
Gaucher Disease	Preclinical	Canada	Genzyme Corp.	27 Oct 2015
Gaucher Disease	Preclinical	Russia	Genzyme Corp.	27 Oct 2015
Gaucher Disease	Preclinical	Tunisia	Genzyme Corp.	27 Oct 2015
Gaucher Disease, Type 1	Preclinical	Russia	Genzyme Corp.	01 Sep 2009
Gaucher Disease, Type 1	Preclinical	Argentina	Genzyme Corp.	01 Sep 2009
Gaucher Disease, Type 1	Preclinical	Brazil	Genzyme Corp.	01 Sep 2009
Gaucher Disease, Type 1	Preclinical	Egypt	Genzyme Corp.	01 Sep 2009

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03485677 (ELIKIDS, SSIEM2023)	Phase 3	Gaucher Disease First line CYP2D6 extensive metabolizers \| N370S variant	57	Eliglustat monotherapy	qomscfohyk(dcpiqdysjo) = ivhqlkncze adfqpvpqzn (pjxzlefcip ) View more	-	30 Aug 2023
				Eliglustat plus imiglucerase combination therapy	qomscfohyk(dcpiqdysjo) = nngbcxutof adfqpvpqzn (pjxzlefcip ) View more
ICGG Gaucher Registry (SSIEM2022)	Not Applicable	First line CYP2D6-metabolizer status	-	eliglustat	nlsdpirbfi(qpdcallucv) = rohsmmdhno zjexmxhzlm (noriwweopd ) View more	-	30 Aug 2022
				eliglustat	nlsdpirbfi(qpdcallucv) = pljrllstfe zjexmxhzlm (noriwweopd ) View more
NCT02536755 (EXOSKEL, CTgov)	Phase 3	Gaucher Disease	31	Eliglustat, GZ385660	fhqklgyixm(gmqtnumjuk) = rqxxncxlzd tfyoszampg (xlchdpfbnd, vlmvubnzia - lxamazhxhp) View more	-	15 Jul 2022
NCT00891202 (ENGAGE, Pubmed \| Am J Hematol)	Phase 3	Gaucher Disease, Type 1	40	Eliglustat	(onowwshunf) = mmxqbyasrz izmpimneuu (hwvwdpucgz ) View more	Positive	23 Jun 2021
				Placebo	(kdshldmoea) = vmxsuvhbwf iswjhiqmwb (xkquoghmer ) View more
EHA2019	Not Applicable	Gaucher Disease, Type 1 First line	-	Eliglustat	kgeitckkpz(jjquhgognn) = rufttfzqut uuhjugvldb (fppjrehcxy ) View more	-	14 Jun 2019
NCT00358150 (Pubmed \| Am J Hematol) Manual	Phase 2	Gaucher Disease, Type 1 First line	26	eliglustat	(tebukzjqex) = nvygwcaueq gqtupclmif (aygaofospi ) View more	Positive	01 Jan 2019
NCT01074944 (EDGE, Pubmed) Manual	Phase 3	Gaucher Disease, Type 1	170	eliglustat (once-daily)	(fycuzbjbpn) = vkkkkdcjff nbxpuabgom (fafjvzdvcb, 67.6 - 89.8)	Positive	01 Mar 2018
				eliglustat (twice-daily)	(fycuzbjbpn) = qwjccobxbz nbxpuabgom (fafjvzdvcb, 71.0 - 91.6)
NCT01074944 (EDGE, CTgov)	Phase 3	Gaucher Disease, Type 1	170	PAP+Eliglustat (PAP, Eliglustat: Once Daily)	bucqdqihha(visrzawaee) = uofoyauwyv jvssaydcsv (kzotntxumg, ceedhbatyp - qohgwdpgun) View more	-	02 Dec 2016
				PAP+Eliglustat (PAP, Eliglustat: Twice Daily)	bucqdqihha(visrzawaee) = rvzlnagqoq jvssaydcsv (kzotntxumg, hjmhvjjqcd - mpfnkfuzqs) View more
NCT00943111 (ENCORE, Pubmed \| Lancet) Manual	Phase 3	Gaucher Disease, Type 1	160	Eliglustat	(tlhhmqoote) = rrtuukjgvz bzaqebkyqu (kablokjytq ) View more	Non-superior	13 Jun 2015
				imiglucerase	(tlhhmqoote) = iautcxiiht bzaqebkyqu (kablokjytq ) View more
NCT00891202 (ENGAGE, Pubmed \| J Coll Physicians Surg Pak \| JAMA) Manual	Phase 3	Splenomegaly \| Gaucher Disease, Type 1	40	eliglustat	(lrlladsqhq) = dddgumwuad ftwlxroblf (hwnajcvokd, -32.57 to -22.97)	Positive	17 Feb 2015
				Placebo	(lrlladsqhq) = kklgplqqix ftwlxroblf (hwnajcvokd, -2.54 to 7.06)

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