Isatuximab-IRFC

Sanofi has outlined plans to execute a share buyback programme of €5bn in 2025. Credit: ArDanMe/Shutterstock. Sanofi has announced an increase in net income from continuing operations for the fourth quarter (Q4) of 2024, reaching €880m ($916m) compared to a loss of €119m ($123.9m) in the same period in 2023. The company’s income before tax and associates and joint ventures also increased to €1.06bn compared to a €75m loss in Q4 2023. The operating income for the quarter was reported at €1.18bn against €384m in the same quarter of the previous year. Gross profit for the quarter stood at €7.84bn, up on €7.43bn in the same period of 2023. Sanofi’s net sales for Q4 2024 also saw a rise, reaching €10.56bn against €9.68bn in the same quarter of 2023. The company’s research and development expenses amounted to €2.25bn in Q4 2024. In 2025, Sanofi anticipates sales growth by a mid-to-high single-digit percentage at constant exchange rates. The company has outlined plans to execute a share buyback programme of €5bn during the year, preferably through block trades and in the open market. Sanofi CEO Paul Hudson stated: “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% of sales, with Beyfortus becoming a blockbuster in its first full year of sales. “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 €22bn in 2030, in line with the current ambition), and expected future launches from our pipeline.” In November 2024, the European Medicines Agency Committee for Medicinal Products for Human Use recommended the approval of Sanofi’s Sarclisa with Velcade, plus Revlimid, plus dexamethasone (VRd) for treating newly diagnosed multiple myeloma (MM).

Sanofi’s Sarclisa (isatuximab) has been approved by the Medicines and Healthcare product Regulatory Agency (MHRA) as part of a combination treatment for newly diagnosed multiple myeloma (MM). The regulator has approved the drug for use alongside standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) to treat adults who are ineligible for autologous stem cell transplant (ASCT). An estimated 5,900 new cases of MM, an incurable cancer of the blood plasma cells, are diagnosed in the UK every year. Administered as an intravenous infusion, Sanofi’s Sarclisa is designed to bind to the CD38 protein on MM cells and induce distinct anti-tumour activity. The MHRA’s decision on the anti-CD38 quadruplet therapy, which comes less than a week after the European Commission approved the Sarclisa combination for the same patient population, was based on positive results from the phase 3 IMROZ trial. The open-label trial achieved its primary endpoint, with Sarclisa plus VRd followed by Sarclisa and Rd reducing the risk of disease progression or death by 40% compared to VRd followed by Rd. Median progression-free survival (PFS) with the Sarclisa/VRd combination was not reached after a median follow up of 59.7 months versus 54.3 months with VRd, and the estimated PFS at 60 months was 63.2% for patients randomised to receive Sarclisa/VRd compared to 45.2% for the VRd cohort. Benefits were also seen across the study’s secondary endpoints, and the safety and tolerability of the combination was consistent with the known safety profile of each agent. Sarclisa/VRd in this indication will now be evaluated by the National Institute for Health and Care Excellence to determine whether it will be reimbursed for use on the NHS. Anju Bhalla, head of oncology and haematology at Sanofi UK and Ireland, said: “While significant strides have been made in MM treatment there is a continued unmet need for patients with MM. Effective first-line treatment is essential in managing and delaying disease progression for newly diagnosed transplant ineligible MM patients. “With [the MHRA’s] decision, patients across the UK are a step closer to accessing a new combination therapy.” The Sarclisa combination has also already been approved by the US Food and Drug Administration to treat newly diagnosed MM in adults ineligible for ASCT.