Calliditas Therapeutics(CALT) - 2023 Q4 - Annual Report

Foreign Exchange Impact - Foreign exchange rate difference translation gains were SEK 1.3 million for the year ended December 31, 2023, compared to SEK 46.6 million in 2022[868] - A 10% stronger Euro against the Swedish Krona would negatively impact profit after tax and equity by approximately SEK 29.3 million for the year ended December 31, 2023[870] - A 10% stronger US dollar against the Swedish Krona would positively impact profit after tax and equity by approximately SEK 0.1 million for the year ended December 31, 2023[870] - The company's transaction exposure in foreign currency has been increasing year by year, with primary exposure in Euros and US dollars[917] TARPEYO and Nefecon Clinical Data - TARPEYO received full FDA approval on December 20, 2023, for reducing kidney function loss in adults with IgAN at risk for disease progression[537] - In the Phase 3 NefIgArd trial, Nefecon showed a 31% reduction in UPCR compared to a 5% reduction in placebo-treated patients after nine months of treatment[979] - Proteinuria reduction was 52% from baseline in Nefecon-treated patients compared to 7% in placebo-treated patients at 12 months[979] Disease Prevalence and Patient Impact - IgAN affects approximately 130,000 to 150,000 people in the United States and approximately 200,000 people in Europe, with a significantly higher prevalence in Asia, particularly Greater China, affecting around 5 million people[539] - The company estimates approximately 140,000 patients in the United States are affected by PBC, with an annual incidence ranging from 0.3 to 5.8 cases per 100,000[992] Remediation and Internal Controls - The company has initiated a remediation plan to address material weaknesses, including increasing dedicated resources and improving reporting processes[914]