Presentation

Company Profile
Calliditas Therapeutics is a specialty pharmaceutical company focused on developing medical products for patients with significant unmet medical needs in niche indications, where the company can partially or completely participate in the commercialization. Calliditas is focused on the development and commercialization of its lead product candidate Nefecon, which has successfully completed its clinical development for patients with inflammatory kidney disease (IgA nephropathy) who are at risk of progressing to renal failure. Nefecon is expected to be the first drug approved within this indication.

Recent highlights
In January 2021, Calliditas announced the clinical development plan for its second asset, setanaxib, for the treatment of primary biliary cholangitis. Based on nefecon’s outstanding and consistent Ph2 and Ph3 data, the company submitted the drug’s CTA to both FDA (March 2021) and EMA (May 2021). This April, the FDA granted priority review to nefecon (similar procedure granted by EMA too, already prior MAA submission). In order to ramp up launch activities, the company closed a directed share issue raising proceeds of SEK 324m in August.

Outlook
We expect US market approval within the multibillion-dollar indication on September 15th, nefecon’s PDUFA date set by the FDA. With that, nefecon will be the only drug on the market with competition reaching the market earliest in summer 2022 (Travere Therapeutics). Approval in Europe is likely to follow within late Q1 2022.