Viking Therapeutics(US:VKTX)2022-07-27 21:11Revenue Generation - The company has not generated any revenue to date and does not expect to receive revenue from drug candidates until regulatory approval and commercialization occur [121]. Research and Development Expenses - Research and development expenses for the year ended December 31, 2021, were $45.0 million, primarily for the VK2809 Phase 2b VOYAGE clinical trial and VK0214 studies [122]. - For the six months ended June 30, 2022, research and development expenses were $26.1 million, focusing on VK2809, VK0214, and VK2735 clinical trials [122]. - Research and development expenses for the three months ended June 30, 2022, increased by 5.8% to $13,542,000 compared to $12,804,000 in 2021, primarily due to increased manufacturing and clinical study expenses [131]. - Research and development expenses for the six months ended June 30, 2022, increased by 7.2% to $26,097,000 from $24,340,000 in 2021, driven by higher manufacturing and clinical study costs [137]. Clinical Trials - The company has completed eight clinical studies for VK2809, enrolling over 300 subjects, with no serious adverse events reported [109]. - VK0214 is in a Phase 1b clinical trial for X-ALD, which was temporarily placed on clinical hold by the FDA in January 2022 but resumed in July 2022 [113]. - VK2735, a dual agonist for metabolic disorders, is undergoing a Phase 1 clinical trial initiated in January 2022 [114]. - VK5211 showed statistically significant increases in lean body mass in a Phase 2 trial with 108 patients recovering from hip fracture surgery [116]. - The impact of the COVID-19 pandemic on clinical trials has caused delays in patient enrollment and site initiation [119]. General and Administrative Expenses - The company expects general and administrative expenses to increase due to hiring, stock-based compensation, and compliance costs associated with being a public company [125]. - General and administrative expenses for the three months ended June 30, 2022, rose by 49.4% to $4,089,000 from $2,737,000 in 2021, mainly due to higher legal services and stock-based compensation costs [133]. - General and administrative expenses for the six months ended June 30, 2022, increased by 43.3% to $7,779,000 from $5,430,000 in 2021, attributed to increased legal services and stock-based compensation [139]. Cash Flow and Financial Position - Cash used in operating activities for the six months ended June 30, 2022, was $23,972,000, a slight decrease from $24,310,000 in 2021 [149]. - Cash provided by investing activities for the six months ended June 30, 2022, was $20,599,000, primarily from investment maturities of $87,000,000, offset by purchases of $66,400,000 [152]. - As of June 30, 2022, the company had cash, cash equivalents, and short-term investments totaling $168.9 million, expected to fund operations through at least September 30, 2023 [143]. - The company anticipates continued losses as it develops drug candidates and seeks regulatory approvals, indicating a need for additional capital in the future [156]. Company Classification - The company is classified as a smaller reporting company and non-accelerated filer, continuing this status until at least December 31, 2023 [127]. Stock Repurchase Program - The company has a stock repurchase program authorized for up to $50.0 million, with 729,034 shares repurchased under the new program as of June 30, 2022 [148].