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    Viking Therapeutics Inc (VKTX)

    Q1 2024 Earnings Summary

    Reported on Mar 31, 2025 (After Market Close)
    Pre-Earnings Price$65.07Last close (Apr 24, 2024)
    Post-Earnings Price$63.00Open (Apr 25, 2024)
    Price Change
    $-2.07(-3.18%)

    What went well

    • Viking Therapeutics is advancing VK2735, a dual GLP-1/GIP receptor agonist, in both subcutaneous and oral formulations, with promising weight loss data and plans to initiate Phase IIb trials in obesity later this year. The company has completed chronic toxicology studies, allowing for longer dosing durations in future trials.
    • The company has a strong cash position of $963 million, enabling aggressive development of its pipeline through important clinical milestones. Additionally, management is open to potential partnerships or strategic transactions to unlock further value.
    • VK2809, the company's lead candidate for NASH and fibrosis, has shown positive Phase IIb results, and the company expects to report histology data later this quarter. Management plans to schedule an end-of-Phase II meeting with the FDA and is considering partnering the program.

    What went wrong

    • Manufacturing capacity constraints may hinder the commercial supply of VK2735, particularly for higher doses of the oral formulation. Brian Lian acknowledged challenges in the supply chain: "throughout the supply chain, solvents, whatever is needed for solid-phase synthesis fill and finish materials. So it's a pretty thorough shortfall right now." ( ) This could limit availability and affect commercialization efforts.
    • The VOYAGE study for VK2809 may not achieve statistical significance in fibrosis improvement due to insufficient powering. Brian Lian stated: "It wasn't powered on fibrosis. It was powered on NASH resolution rates... I would not be expecting statistical significance just because the numbers are smaller." ( ) This may impact the perceived efficacy of VK2809 in treating NASH with fibrosis.
    • Competition from GLP-1 therapies could impact the market potential for VK2809. Brian Lian noted that the rapid expansion of GLP-1 utilization "probably does create some headwind on the uptick of new NASH drugs" ( ), suggesting increased competition could affect VK2809's market adoption.

    Q&A Summary

    1. VK2809 VOYAGE Study Results
      Q: Expectations on VOYAGE histology endpoints?
      A: Brian Lian anticipates the VOYAGE study to show NASH resolution and fibrosis improvement, aiming for a low to mid-teens percentage difference in NASH resolution between treated and placebo groups. He does not expect statistical significance for fibrosis due to the smaller sample size. Data on NASH resolution and one-point fibrosis improvement will be available soon, with some biopsy data arriving later.

    2. Partnerships or Strategic Transactions
      Q: Plans to seek partnerships or deals?
      A: They believe they have sufficient data to engage in meaningful partnership discussions without needing additional data. While larger partners may prefer more data, it's not a requirement at this point.

    3. VK2735 vs. Tirzepatide Weight Loss
      Q: Will VK2735 outperform tirzepatide?
      A: Brian Lian suggests that at any given dose, VK2735 could achieve higher exposures without increasing tolerability issues. It's uncertain whether it will surpass or match tirzepatide without longer studies.

    4. Manufacturing Challenges for VK2735
      Q: Issues scaling up VK2735 supply?
      A: Current manufacturing shortages affect all doses due to supply chain issues, but this is not expected to be permanent. They anticipate manufacturing capacity will expand over the next few years given the market opportunity.

    5. Phase IIb Study Plans and FDA Discussions
      Q: Updates on Phase IIb and FDA talks?
      A: They plan a Type C meeting with the FDA this quarter to discuss VK2735 study design and duration. A Phase IIb study is expected to start in Q4, possibly lasting 6 or 9 months, depending on FDA guidance on whether a weight loss plateau is needed before Phase III.

    6. VK2809 Phase III and Competition
      Q: Will you proceed to VK2809 Phase III?
      A: After reviewing VOYAGE data, they will meet with the FDA for guidance on Phase III trial design and registration endpoints. They may seek a partner for the program but will decide after seeing the data. Brian Lian notes that GLP-1s are increasingly used in NASH, which could impact market dynamics for thyroid beta agonists.

    7. Potential of SARM 5211 as Add-On
      Q: Thoughts on adding SARM to GLP-1?
      A: Brian Lian acknowledges that VK5211, a potent SARM, could be useful if muscle loss during weight loss is clinically significant. Combining it with GLP-1s may address muscle loss concerns in the pharmacological setting.

    8. Oral VK2735 Dose Escalation
      Q: Update on oral VK2735 dosing?
      A: Dose escalation continues until they reach maximum tolerated dose, observe a plateau in exposure or weight change, or encounter tolerability issues. More data is expected around mid-year.

    9. Additional Trials or Subpopulations
      Q: Plans for trials in subgroups?
      A: While focusing on obesity as the primary indication, they recognize the importance of subpopulations like those with dyslipidemia. Adding cohorts to assess effects on plasma lipids could indicate cardiovascular benefits, but the primary focus remains on weight loss.

    10. Auto-Injector and Bridging Study
      Q: Is a PK bridging study needed?
      A: They will use a pen-type auto-injector for VK2735. If it's not ready before the next study, they'll start with vial and syringe and transition later. They don't anticipate needing a bridging PK study for this transition.

    11. Gannex IP Dispute Timing
      Q: Any updates on Gannex dispute?
      A: A ruling on the Gannex IP dispute is expected this quarter, but it's hard to speculate due to ongoing litigation.

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