Setanaxib is a small molecule commercialized by Calliditas Therapeutics, with a leading Phase III program in Primary Biliary Cholangitis (Primary Biliary Cirrhosis). According to Globaldata, it is involved in 4 clinical trials, of which 3 are ongoing, and 1 is planned. GlobalData uses proprietary data and analytics to provide a complete picture of Setanaxib’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.

The revenue for Setanaxib is expected to reach an annual total of $55 mn by 2036 globally 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.

Setanaxib Overview

Setanaxib (GKT-831; GKT-137831) is under development for the treatment of alport syndrome, kidney disease (nephropathy), primary biliary cholangitis (primary biliary cirrhosis), recurrent head and neck cancer squamous cell carcinoma, idiopathic pulmonary fibrosis. The drug candidate is administered orally. It selectively targets NOX4 and NOX1 over expressed in cancer associated fibroblast (CAF). It was also under development for the treatment of prostate cancer, liver fibrosis, kidney fibrosis, atherosclerosis, non alcoholic steatohepatitis, scleroderma, portal hypertension and kidney disease.

Calliditas Therapeutics Overview

Calliditas Therapeutics develops, identifies and commercializes pharmaceutical products for rare and orphan diseases. The company’s pipeline products include Nefecon, a proprietary oral drug candidate for the treatment of IgA nephropathy and setanaxib, an oral small molecule inhibitor being developed for the treatment of primary biliary cholangitis, head and neck cancer, idiopathic pulmonary fibrosi, and kidney diseases. The company offers products under the brand name TARPEYO. Calliditas Therapeutics works in collaboration with healthcare providers, clinicians and research organizations. The company offers its products and services in Sweden, France, Switzerland and the US. Calliditas Therapeutics is headquartered in Stockholm, Sweden.

The company reported revenues of (Swedish Krona) SEK802.9 million for the fiscal year ended December 2022 (FY2022), compared to a revenue of SEK229.4 million in FY2021. The operating loss of the company was SEK421.9 million in FY2022, compared to an operating loss of SEK524.5 million in FY2021. The net loss of the company was SEK412.3 million in FY2022, compared to a net loss of SEK500.3 million in FY2021. The company reported revenues of SEK191.4 million for the first quarter ended March 2023, a decrease of 55.4% over the previous quarter.

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

This content was updated on 2 September 2023

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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.