Viking Therapeutics(VKTX) - 2025 Q1 - Quarterly Results

Corporate and Pipeline Update Q1 2025 Highlights Viking Therapeutics reported significant Q1 2025 progress, advancing VK2735 with Phase 3 preparation for subcutaneous, full enrollment for oral Phase 2, a new manufacturing agreement, and a strong cash position - Phase 3 trials for subcutaneous VK2735 are on track to begin in Q2 2025[3][5][6] - The Phase 2 VENTURE-Oral Dosing trial for the tablet formulation of VK2735 is fully enrolled, with data expected in the second half of 2025[3][5][8] - A broad, multi-year manufacturing agreement was signed with CordenPharma to support the future commercialization of VK2735, covering both API and fill/finish capacity[3][5][12] - The company maintained a strong balance sheet, ending the quarter with $852 million in cash, cash equivalents, and short-term investments[3][5][17] VK2735 Program Update (Obesity) Viking is advancing its dual GLP-1/GIP receptor agonist, VK2735, for obesity, with the subcutaneous version entering Phase 3 in Q2 2025 and the oral tablet completing Phase 2 enrollment for H2 2025 data - Subcutaneous VK2735: - Set to begin Phase 3 trials in Q2 2025 following a successful End-of-Phase 2 meeting with the FDA[6][7][8] - Previous Phase 2 VENTURE study showed statistically significant mean body weight reductions up to 14.7% after 13 weeks, with an encouraging safety profile[6][7][8] - Oral VK2735: - The 13-week Phase 2a VENTURE-Oral Dosing trial is fully enrolled with approximately 280 subjects[8][9][11] - Top-line data from this study is expected in the second half of 2025[8][9][11] - Previous Phase 1 trial showed dose-dependent weight loss up to 8.2% after 28 days[8][9][11] Other Pipeline and Corporate Developments Viking is advancing its DACRA program for obesity with an IND filing planned for H2 2025, while securing a multi-year manufacturing agreement with CordenPharma for VK2735 API and fill/finish capacity - DACRA Program: The company is advancing its internally developed dual amylin and calcitonin receptor agonist (DACRA) program for obesity and plans to file an IND application in the second half of 2025[11][12] - Manufacturing Agreement: Viking entered a multi-year agreement with CordenPharma to secure dedicated capacity for annual manufacture of multiple metric tons of VK2735 API and fill/finish services for both injectable and oral forms[12][13](index=13&type=chunk] - Viking will make prepayments between 2025 and 2028, which will be credited against future orders[12][13] Financial Performance Q1 2025 Financial Results Viking Therapeutics reported a Q1 2025 net loss of $45.6 million, or $0.41 per share, driven by increased R&D and G&A expenses primarily from manufacturing and clinical activities Financial Performance Summary | Financial Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Research & Development Expenses | $41.4 million | $24.1 million | +71.8% | | General & Administrative Expenses | $14.1 million | $10.0 million | +41.0% | | Loss from Operations | ($55.5 million) | ($34.1 million) | +62.8% | | Net Loss | ($45.6 million) | ($27.4 million) | +66.5% | | Net Loss Per Share | ($0.41) | ($0.26) | +57.7% | - The increase in R&D expenses was mainly due to manufacturing for drug candidates, clinical studies, and stock-based compensation[14] - The rise in G&A expenses was primarily driven by increased legal, patent, stock-based compensation, and insurance costs[15] Balance Sheet and Cash Position As of March 31, 2025, Viking Therapeutics maintained a strong financial position with $852 million in cash, cash equivalents, and short-term investments, and $846.9 million in stockholders' equity - Cash, cash equivalents, and short-term investments totaled $852 million at March 31, 2025, compared to $903 million at December 31, 2024[17] Balance Sheet Summary | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Current Assets | $866.0 million | $907.2 million | | Total Assets | $867.0 million | $908.3 million | | Total Liabilities | $20.1 million | $28.0 million | | Total Stockholders' Equity | $846.9 million | $880.3 million | Supplementary Information Upcoming Investor Events Viking management is scheduled to participate in four investor conferences during June 2025, including events hosted by William Blair, Jefferies, Goldman Sachs, and ScotiaBank - Management will participate in the following June 2025 conferences: - William Blair Annual Growth Stock Conference (June 3-5)[13] - Jefferies Global Healthcare Conference (June 3-5)[13] - 46th Annual Goldman Sachs Global Healthcare Conference (June 9-11)[13] - ScotiaBank Third Annual Healthcare Canadian Investor Day (June 17)[13] Conference Call Information The company hosted a conference call on April 23, 2025, at 4:30 pm Eastern to discuss Q1 2025 financial results, with webcast and replay options available - A conference call was scheduled for 4:30 pm Eastern on April 23, 2025[19] - A live webcast is available on the investor relations section of the company's website, with an archive available for 30 days[19]