|MedHunter Club Research Team
On April 25, Sanofi announced its financial results for the first quarter of 2024, with three months' revenue reaching €10.464 billion (Approximately 122.2 billion US dollars, calculated at an exchange rate of 1 euro ≈ 1.0723 US dollars), according to CER calculations, representing a year-over-year increase of 6.7%. By region, the U.S. generated the highest revenue at €4.316 billion, up 7.3% year-over-year; revenue in China reached €757 million, reflecting a 6.2% year-over-year growth. The growth in China was primarily driven by Dupixent, Toujeo, and Plavix.
- Dupixent (dupilumab) sales reached 2.835 billion euros, increasing by 24.9% year-on-year. The sales target for this product in 2024 is approximately 13 billion euros. Outside Europe and the United States, Japan and China areDupilumabMain Source of Sales Growth;
- Products Nexviazyme and ALTUVIIIO led the gains, marketed drugs (Specifically refers to Sanofi8 marketed drugs) Sales increased by 90.5%, reaching 606 million euros;
- Driven by Beyfortus, vaccine sales increased by 5.6%, reaching €1.177 billion in revenue;
- Consumer Health Business Revenue: €1.525 billion, increased by 9.0%.
R&D expenses increased by 11.8% year-on-year to 1.719 billion euros during the reporting period:- Dupixent、BeyfortusReceived Three Regulatory Approvals:
--Dupixent approved in the U.S. for the treatment of children aged 1-11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE);--Dupixent has been approved in Japan for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older whose condition is not adequately controlled by existing therapies;--Beyfortus Approved in Japan as the First Drug Authorized to Protect All Children from RSV Infection.- Positive Phase 3 Clinical Results for Rilzabrutinib in the Treatment of Rare Disease Immune Thrombocytopenia;
- The number of pipelines will continue to increase from 2024 to 2025, including the interpretation of 12 Phase III data.
Dupixent: Sales of 2.835 billion euros, on track to achieve 2024 sales targetSanofi's leading product Dupilumab achieved sales of 2.835 billion euros (Approximately USD 3.04 billion), an increase of 24.9% year-on-year. Of which, sales revenue in the U.S. reached 2.03 billion euros（Approximately USD 2.177 billion）; Outside the U.S., sales grew by 51% year-over-year due to expanded indications, reaching 805 million euros.（Approximately USD 863 million), with China and Japan being the main sources.Sanofi stated that Dupilumab has the potential to achieve the sales target of 13 billion euros in 2024. In the first half of 2024, new indications were approved respectively in the United States and Japan. Additionally, regarding the indication for COPD, the FDA's target action date for a decision is June 27, 2024. The second half of 2024 remains highly anticipated, with registration decisions for the COPD indication upcoming in Europe and China, as well as a registration decision for eosinophilic esophagitis expected in Europe.
Newly Listed Product: Accounts for 9% of the Company's Biopharmaceutical Sales RevenueSanofi stated that the cumulative sales of newly launched products such as Beyfortus and Nexviazyme reached 788 million euros, representing a 150% year-on-year increase.
Beyfortus: 182 million eurosBeyfortus is a long-acting antibody therapy designed for all infants and toddlers, requiring only a single dose from birth through their first RSV season to prevent diseases associated with RSV infection. Beyfortus was approved in November 2022.First Global ApprovalLaunched to prevent lower respiratory tract diseases in newborns caused by infection during their first RSV season. Approved by the U.S. FDA in July 2023.Nexviazyme: 152 million eurosNexviazyme is an enzyme replacement therapy for the treatment of Pompe disease, which targets the mannose-6-phosphate (M6P) receptor to enhance cellular enzyme uptake and increase glycogen clearance in target tissues, helping to reduce glycogen accumulation. On August 6, 2021, the product received FDA approval in the United States for the treatment of late-onset Pompe disease in patients aged one year and older. Previously, the FDA granted Nexviazyme breakthrough therapy designation and fast track designation for the treatment of Pompe disease. As a rare disease drug, Nexviazyme has already demonstrated excellent market performance, and its future market potential is highly anticipated.ALTUVIIIO: 122 million eurosALTUVIIIO (Efanesoctocog alfa) is a first-in-class, highly persistent Factor VIII replacement therapy. By fusing Factor VIII with Fc, a portion of von Willebrand factor (vWF), and an XTEN polypeptide fragment, it overcomes the vWF limitation on the extended half-life of FVIII, significantly prolonging the drug's presence in the bloodstream. In February 2023, the U.S. FDA approved the drug for marketing for the treatment of Hemophilia A.Main Products 2024Q1 Sales Revenue
Key Pipeline Milestones Expected to Be Achieved in 2024
The first half of 2024:
Kevzara（Sarilumab）Sarilumab is a fully human monoclonal antibody that inhibits the IL-6 pathway by binding to and blocking the interleukin-6 (IL-6) receptor, thereby inhibiting IL-6-mediated signaling. The U.S. FDA will make a regulatory decision on the use of this drug for the treatment of juvenile idiopathic arthritis in the first half of 2024.MenQuadfi: This is an innovative meningococcal vaccine from Sanofi. The Phase 3 clinical data for the treatment of meningitis in infants aged six weeks and above is about to be read out.Dupixent: A registration decision for the COPD indication is expected in Europe; Phase 3 clinical data for the treatment of chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP) will be read out soon.Rilzabrutinib: is a potential first-in-class BTK inhibitor that has recently achieved the primary endpoint of the LUNA 3 Phase 3 clinical trial, demonstrating significant clinical improvement in symptoms of patients with Immune Thrombocytopenia (ITP). Regulatory submissions to the U.S. FDA and the EU are expected by the end of this year. Additionally, data from Phase 2 clinical studies for the treatment of IgG4-related diseases and warm autoimmune hemolytic anemia are expected to be read out soon.Amlitelimab: A potential first-in-class OX40 signaling pathway blocker, the Phase 2 clinical trial data for asthma treatment is expected to be released in the second half of 2024. In China, a Phase 3 clinical trial for treating moderate to severe atopic dermatitis in patients aged 18 and above was initiated on April 25, 2024.Tolebrutinib: An oral BTK inhibitor capable of crossing the blood-brain barrier, Sanofi is currently conducting several pivotal Phase 3 clinical trials to evaluate its efficacy in treating various types of multiple sclerosis patients. The results of the Phase 3 clinical studies for relapsing multiple sclerosis and non-relapsing secondary progressive multiple sclerosis are expected to be available by the second half of 2024, with regulatory submissions planned in the U.S. for these two indications.
Business Dynamics Expected in 2024
2024Q2 Sales:
Dupixent and Pharmaceuticals (8 drugs): Sales will continue to grow;Beyfortus: No sales expected; attributed to early delivery/seasonal factors;Aubagio: LoE Impact on EU Region.Dupixent: Expected to achieve approximately 13 billion euros in sales;Vaccines: Expected to achieve mid-single-digit growth;Beyfortus: Will Achieve Very Significant Sales Growth;Aubagio: LoE impact, mainly in the first half of the year;GenMed: Lantus stabilizes, divestment of approximately 300 million euros.
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