Release Date: April 23, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Viking Therapeutics Inc (VKTX, Financial) announced positive data from four separate clinical programs, including VK2735 for obesity and VK2809 for NASH and fibrosis.
- The company made significant progress toward initiating Phase 3 trials for the subcutaneous VK2735 program, expected to commence later this quarter.
- Viking Therapeutics Inc (VKTX) completed enrollment for the Phase 2 trial of the VK2735 oral tablet for obesity, indicating strong interest in the program.
- A long-term manufacturing agreement was secured to support the future commercialization of VK2735, suggesting readiness for large-scale production.
- The company maintains a strong financial position with over $850 million in cash, providing a solid runway for ongoing and future clinical trials.
Negative Points
- Research and development expenses increased significantly to $41.4 million, impacting the company's financials.
- The net loss for the first quarter of 2025 was $45.6 million, a substantial increase from the previous year.
- General and administrative expenses rose to $14.1 million, driven by legal, patent services, and stock-based compensation costs.
- There is uncertainty regarding the potential impact of tariffs on future operations, which could affect commercial activities.
- The company faces logistical challenges in preparing for the Phase 3 trials, including supply chain and site readiness.
Q & A Highlights
Q: Is the Phase 2 VENTURE-Oral readout going to include the four-week follow-up data or will the top line data only include data with 13 weeks of dosing? And when do you plan on introducing the auto-injector into the Phase 3?
A: The top line data from the Oral study will likely be reported before the four-week follow-up data are available. The introduction of the auto-injector is expected early next year, with a bridging study comparing the vial and syringe to the auto-injector in the interim. - Brian Lian, CEO
Q: What specific level of weight loss are you looking to achieve in the Phase 2 VENTURE-Oral data?
A: If we can show around 8% weight loss, similar to what was shown at the high dose last time after 12 weeks, it would be a competitive profile. However, it's hard to predict prior to unblinding the data. - Brian Lian, CEO
Q: Are you planning to test oral VK2735 in other indications besides obesity, like type 2 diabetes?
A: The Phase 3 program will include one study in obese subjects and another in obese diabetics, which will provide data on weight change and glycemic control in type 2 patients. - Brian Lian, CEO
Q: Can you provide an update on the logistics before initiating Phase 3 for VK2735? Are the remaining tasks more regulatory or operational?
A: We plan to initiate the study in the second quarter, with preparations primarily logistical, such as getting supplies ready and sites prepared. There is no reason to think we can't meet this timeline. - Brian Lian, CEO
Q: Are you able to comment on the cost of goods sold (COGS) for the manufacturing side with CordenPharma?
A: It's difficult to discuss COGS specifics, but we expect margins consistent with other peptide products. The manufacturing agreement is large-scale with tiered pricing, which is favorable to us. - Brian Lian, CEO
Q: How do you plan to incorporate the auto-injector and monthly dosing regimen into the Phase 3 trials?
A: The auto-injector will be introduced into Phase 3 following a comparative study. The monthly regimen will first be studied separately, and its incorporation into Phase 3 is yet to be determined. - Brian Lian, CEO
Q: What are your thoughts on the potential for direct-to-consumer models in the obesity market?
A: Direct-to-consumer models have proven viable, providing optionality and different avenues to market the product. It's early to decide, but this model is a viable channel. - Brian Lian, CEO
Q: Is the formulation for the oral VK2735 program finalized, or are you still optimizing it?
A: We are mostly set with the current formulation, though minor changes may occur. - Brian Lian, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
