Tolebrutinib is a small molecule commercialized by Sanofi, with a leading Phase III program in Primary Progressive Multiple Sclerosis (PPMS). According to Globaldata, it is involved in 15 clinical trials, of which 7 were completed, 7 are ongoing, and 1 is planned. GlobalData uses proprietary data and analytics to provide a complete picture of Tolebrutinib’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.

The revenue for Tolebrutinib is expected to reach an annual total of $359 mn by 2034 in the US based off GlobalData’s Expiry Model. The drug’s revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

Tolebrutinib Overview

SAR-442168 (PRN-2246) is under development for the treatment of  primary progressive multiple sclerosis (PPMS), relapsing remitting multiple sclerosis (RRMS), myasthenia gravis (MG) and unspecified indication. It is a small molecule administered through oral route. It acts by targeting Bruton’s tyrosine kinase (BTK) enzyme. The drug candidate is based on Tailored covalency technology platform. It was also under development for the treatment of solid tumors, secondary progressive multiple sclerosis (SPMS), generalized myasthenia gravis (MG), relapsing multiple sclerosis (RMS).

Sanofi Overview

Sanofi is a healthcare company, which is engaged in the discovery, development, manufacturing and marketing of a wide range of medicines and vaccines. Its portfolio includes medicines for the treatment of cancer, diabetes, rare diseases, multiple sclerosis and cardiovascular diseases; human vaccines for protection against various bacterial and viral diseases; and other products. The company also offers consumer healthcare products for digestion; allergy; cough, cold, flu and sinus; pain; women’s health; and vitamins, minerals and supplements. Sanofi‘s R&D efforts focus on advancing a combination drugs to increase the effectiveness of treatments and on advancing the formulation of new biologics to produce precision medicines. It has operations in Europe, the Americas, Asia-Pacific, Africa and the Middle East. Sanofi is headquartered in Paris, France.

The company reported revenues of (Euro) EUR45,389 million for the fiscal year ended December 2022 (FY2022), an increase of 15.9% over FY2021. The operating profit of the company was EUR8,502 million in FY2022, compared to an operating profit of EUR8,126 million in FY2021. The net profit of the company was EUR6,720 million in FY2022, compared to a net profit of EUR6,223 million in FY2021.

For a complete picture of Tolebrutinib’s valuation, buy the drug’s risk-adjusted NPV model (rNPV) here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, drug margins and company expenses. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate valuation, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA) and phase transition success rate (PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.