Financial Performance - Fourth quarter revenues increased 116% to 290.5 million compared to 2023 [1] - Net income for the fourth quarter was 1.58 per common share (basic) [20] - Net income for the full year was 3.12 per common share (basic) [20] - Gross margin for the fourth quarter was 95% [7] Business Developments - The Company received full sanctioning of the KB407 Phase 1 protocol from the Cystic Fibrosis Foundation Therapeutic Development Network [1][8] - The Company has secured over 510 reimbursement approvals for VYJUVEK in the U.S. [7] - The Company is focused on executing the global launch of VYJUVEK and advancing multiple clinical stage programs in 2025 [2] Clinical Pipeline - VYJUVEK is indicated for the treatment of Dystrophic Epidermolysis Bullosa (DEB) [3][22] - The Company has enrolled approximately 50 DEB patients in a natural history study for KB803, with a Phase 3 study expected to commence in 1H 2025 [5] - KB407 is being evaluated in a Phase 1 study for cystic fibrosis, with interim data expected in mid-2025 [8][9] - KB408 for alpha-1 antitrypsin deficiency has shown promising initial data, with results from expanded cohorts expected in 2H 2025 [9] - Inhaled KB707 for lung tumors has shown an objective response rate of 27% in advanced non-small cell lung cancer patients [11] Financial Guidance - The Company projects non-GAAP combined R&D and SG&A expenses for FY 2025 to be between 175 million [18]
Krystal Biotech Announces Fourth Quarter and Full Year 2024 Financial and Operating Results