Recently, the French pharmaceutical giant Sanofi announced its latest pipeline developments and performance for Q3 2024.

Performance Overview

The financial report shows that total sales for Q3 2024 reached €13.4 billion, a year-on-year increase of 15.7%, primarily due to early sales of influenza and respiratory syncytial virus vaccines. Thanks to strong business performance, Sanofi has raised its earnings per share guidance for 2024 to at least achieve low single-digit percentage growth.

In terms of segments, pharmaceutical business revenue for Q3 2024 was €8.365 billion, a year-on-year increase of 13%; vaccine revenue was €3.802 billion, a year-on-year increase of 25.5%, mainly due to phased sales of the influenza vaccine and growth from increased production capacity for Beyfortus following its approval; consumer healthcare revenue was €1.271 billion, a year-on-year increase of 7.9%. Sanofi expects to complete the spin-off of its consumer healthcare business by Q2 2025 at the earliest, focusing on innovative pharmaceuticals and vaccines.

By product, Dupixent (dupilumab) was the top-selling product, with sales of €3.476 billion in Q3 2024, a year-on-year increase of 23.8%. Total sales of Dupixent for the first three quarters of 2024 reached €9.614 billion, and sales for 2024 are expected to reach €13 billion.

Pipeline Adjustments

In Q3 2024, Sanofi removed two Phase III studies and one Phase II study from its pipeline.

Losmapimod for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD) - Phase III Study

Losmapimod is an oral selective p38α/β mitogen-activated protein kinase (MAPK) inhibitor, originally developed by GlaxoSmithKline (GSK). In April 2019, Fulcrum acquired all rights to losmapimod from GSK. On May 13 of this year, Sanofi acquired the development and commercialization rights for losmapimod from Fulcrum Therapeutics.

According to the terms of the agreement, Fulcrum will receive an $80 million upfront payment and is eligible for up to $975 million in additional payments upon reaching specific regulatory and sales milestones, as well as tiered royalties starting from low double digits on annual net sales of losmapimod outside the U.S.

On September 12, 2024, Fulcrum Therapeutics announced that the Phase III REACH trial of losmapimod for FSHD failed to meet its primary endpoint. Moreover, the secondary endpoints also lacked statistical significance. The safety and tolerability of losmapimod were consistent with previously reported study results. The company will complete a comprehensive evaluation of the data obtained and plans to share the assessment results at an upcoming medical conference. Following this announcement, Fulcrum's stock price fell by approximately 61%.

Meningococcal Vaccine MenQuadfi - Phase III Study

MenQuadfi is an innovative meningococcal vaccine from Sanofi, and it is the only quadrivalent meningococcal vaccine approved by the U.S. FDA for individuals aged 2 years to 56 years and older. This vaccine is also the first and only quadrivalent meningococcal vaccine in the U.S. to use tetanus toxoid as a protein carrier. The termination concerns a six-week+ Phase III study of MenQuadfi.

Oditrasertib for the Treatment of Multiple Sclerosis (MS) - Phase II Study

Oditrasertib is a RIPK1 inhibitor. Sanofi and Denali partnered in 2018 to develop RIPK1 inhibitors for treating a range of neurological and systemic inflammatory diseases. According to the terms of the agreement, Sanofi will make a $125 million upfront payment to Denali, with potential milestone payments exceeding $1 billion for development and commercialization.

Sanofi is stopping the Phase II study of oditrasertib in multiple sclerosis because the candidate failed to meet its primary and key secondary endpoints. This is not the first failure for this drug this year. In April 2024, Sanofi announced the termination of the Phase II trial of oditrasertib in amyotrophic lateral sclerosis (ALS) due to disappointing interim results; in February 2024, the Phase II HIMALAYA study of oditrasertib for ALS did not meet its primary endpoint.

Sanofi's Q3 pipeline progress included four regulatory approvals and four positive results from Phase III studies. Dupixent was approved in the U.S. and China for the COPD indication, and it was also approved in the U.S. for adolescents for chronic sinusitis with nasal polyps. Another regulatory approval was for Sarclisa in multiple myeloma indications. In Phase III studies, Dupixent's BP and CSU studies met their primary endpoints; Tolebrutinib's nrSPMS study and Sarclisa's NDMM and TE studies also achieved their primary endpoints.

Sanofi expects several pipeline milestones in Q4 2024, including interim clinical trials for the oral BTK inhibitor ralzabrutinib for the treatment of IgG4-mediated diseases and the anti-TL1A biologic duvakitug for treating inflammatory bowel disease.