• Research and Development Expenses (Q4 2024): $31 million, up from $20.5 million in Q4 2023.
• General and Administrative Expenses (Q4 2024): $15.3 million, up from $8.8 million in Q4 2023.
• Net Loss (Q4 2024): $35.4 million or $0.32 per share, compared to $24.6 million or $0.25 per share in Q4 2023.
• Research and Development Expenses (Full Year 2024): $101.6 million, up from $63.8 million in 2023.
• General and Administrative Expenses (Full Year 2024): $49.3 million, up from $37 million in 2023.
• Net Loss (Full Year 2024): $110 million or $1.01 per share, compared to $85.9 million or $0.91 per share in 2023.
• Cash, Cash Equivalents, and Short-term Investments (End of 2024): $903 million, up from $362 million at the end of 2023.

• Warning! GuruFocus has detected 2 Warning Sign with VKTX.

Release Date: February 05, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Viking Therapeutics Inc (NASDAQ:VKTX) reported successful results from four different studies across its pipeline in 2024, including positive data from the VK2735 subcutaneous and oral tablet programs for obesity.
• The VK2809 program for the treatment of MASH and fibrosis achieved its primary, secondary, and exploratory endpoints, showing significant reductions in liver fat and improvements in MASH resolution rate and fibrosis.
• The company announced positive results from a Phase 1b clinical trial of VK0214 for X-linked adrenoleukodystrophy, demonstrating safety, tolerability, and significant reductions in plasma levels of very long chain fatty acids.
• Viking Therapeutics Inc (NASDAQ:VKTX) closed a successful public offering of common stock, raising over $630 million, which bolstered its financial position with over $900 million in cash by the end of 2024.
• The company plans to initiate Phase 3 trials for VK2735 in obesity in the second quarter of 2025, indicating a clear path forward for its lead program.

Negative Points

• Viking Therapeutics Inc (NASDAQ:VKTX) reported a net loss of $110 million for the year ended December 31, 2024, an increase from the $85.9 million loss in 2023, primarily due to increased research and development and administrative expenses.
• Research and development expenses rose significantly to $101.6 million in 2024 from $63.8 million in 2023, driven by increased manufacturing costs for drug candidates and stock-based compensation.
• General and administrative expenses also increased to $49.3 million in 2024 from $37 million in 2023, due to higher costs related to stock-based compensation, salaries, and professional fees.
• The company faces logistical challenges in manufacturing and preparing clinical materials for its Phase 3 trials, which could impact timelines.
• There is uncertainty regarding the recruitment timeline for the Phase 3 obesity studies, as the company has not yet provided guidance on patient enrollment duration.

Q & A Highlights

Q: Can you provide more details on the feedback from the end of Phase 2 meeting, particularly regarding the potential size and comparator arms for the Phase 3 studies? A: Brian Lian, President and CEO, stated that the Phase 3 program will conform to guidance requiring at least 4,500 participants. There will be two studies: one in obese subjects and another in obese subjects with type 2 diabetes, targeting a 52-week treatment window. Further details on doses and other specifics will be provided upon trial initiation.

Q: Why was the timing for the start of the Phase 3 obesity study narrowed to the second quarter of 2025? A: Brian Lian explained that the adjustment was primarily logistical, related to the production of clinical materials. With better visibility on production timelines, they could focus the start window more precisely. Everything is proceeding according to plan.

Q: Are the Phase 3 studies going to be standard weight loss studies, and how long will it take to recruit patients? A: Brian Lian confirmed that the primary endpoint will be a change in body weight, with glycemic endpoints included in the diabetes study. The recruitment timeline cannot be provided yet as it depends on study initiation and enrollment queue.

Q: Will the monthly dosing for the subcutaneous formulation be included in the Phase 3 study and eventually in the label? A: Brian Lian mentioned that the long-term goal is to include monthly dosing in the label, though it's too early to determine if it will be in the initial NDA. The study will explore transitioning from weekly to monthly dosing to assess weight maintenance.

Q: For the Phase 2 oral VENTURE trial, why is the dose range broad, and is the highest dose realistic for pursuit? A: Brian Lian stated that the broad dose range is to evaluate if lower doses continue to show efficacy over a longer period. The highest dose tested in Phase 1 was well tolerated, and they are comfortable exploring slightly higher doses.

Q: What are the expectations for the 13-week weight loss in the VENTURE oral Phase 2 study, and can you comment on the cost of goods sold? A: Brian Lian indicated it's too early to predict 13-week weight loss outcomes. Regarding cost of goods sold, it's premature to discuss specifics, but they aim for a profitable product.

Q: Is there an update on the manufacturing agreement, and why is it taking time to finalize? A: Brian Lian noted that discussions are ongoing to enable the launch of a substantial commercial product. Progress is being made, and more information will be shared at the appropriate time.

Q: Regarding the amylin program, what needs to be completed for IND submission this year? A: Brian Lian stated that all IND-enabling work, particularly toxicology studies, needs to be completed to enable an IND filing this year.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.