Viking Therapeutics, Inc. (VKTX) Q3 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call indicates strong financial health with $800 million in cash, a strategic focus on obesity and diabetes treatments, and ongoing trials. The Q&A reveals no major risks or uncertainties, and management's confidence in fiscal discipline and pipeline advancement is reassuring. However, lack of specific timelines for some projects and management's reluctance to comment on certain deals slightly temper enthusiasm. Overall, the company's strong cash position and strategic focus on high-demand areas suggest a positive outlook.

Key Financial Performance

Research and Development Expenses (Q3 2025) $90 million, a significant increase from $22.8 million in Q3 2024. The increase was primarily due to higher expenses related to clinical studies, manufacturing for drug candidates, salaries and benefits, and regulatory services, partially offset by a decrease in stock-based compensation.

General and Administrative Expenses (Q3 2025) $8.6 million, a decrease from $13.8 million in Q3 2024. The decrease was primarily due to reduced expenses related to legal and patent services and stock-based compensation, partially offset by increased expenses related to salaries and benefits.

Net Loss (Q3 2025) $90.8 million or $0.81 per share, compared to $24.9 million or $0.22 per share in Q3 2024. The increase in net loss was primarily due to the rise in research and development expenses.

Research and Development Expenses (9 months ended September 30, 2025) $191.5 million, up from $70.7 million in the same period in 2024. The increase was due to higher expenses related to clinical studies, manufacturing for drug candidates, salaries and benefits, stock-based compensation, and regulatory services, partially offset by decreased expenses related to preclinical studies.

General and Administrative Expenses (9 months ended September 30, 2025) $37.1 million, up from $34 million in the same period in 2024. The increase was due to higher expenses related to stock-based compensation and insurance, partially offset by reduced expenses related to legal and patent services.

Net Loss (9 months ended September 30, 2025) $202 million or $1.80 per share, compared to $74.5 million or $0.69 per share in the same period in 2024. The increase in net loss was due to higher research and development and general and administrative expenses, partially offset by increased interest income.

Cash, Cash Equivalents, and Short-term Investments (as of September 30, 2025) $715 million, down from $903 million as of December 31, 2024. The decrease reflects the company's ongoing operational and development expenses.

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Operating Highlights

VK2735 Phase III VANQUISH Obesity Program: Initiated Phase III trials for VK2735, targeting obesity and obesity with type 2 diabetes. The trials are randomized, double-blind, placebo-controlled, and multicenter, with weekly subcutaneous injections for 78 weeks. Enrollment is progressing well, with completion expected by the end of 2025 for VANQUISH-1 and Q1 2026 for VANQUISH-2.

VK2735 Oral Tablet Formulation: Positive Phase II results from the VENTURE-Oral Dosing Study showed statistically significant weight loss (up to 12.2% reduction) and good safety/tolerability over 13 weeks. Plans to submit an end of Phase II meeting request to the FDA for next steps.

Amylin Receptor Agonist Program: Progressing toward an IND filing in Q1 2026 for a novel amylin receptor agonist targeting appetite and body weight regulation. Planned Phase I studies include single and multiple ascending dose studies.

Financial Position: Cash reserves of $715 million as of September 30, 2025, sufficient to complete planned Phase III trials and additional programs.

Research and Development Expenses: R&D expenses increased to $90 million in Q3 2025 (from $22.8 million in Q3 2024) due to clinical studies, manufacturing, and regulatory services.

Pipeline Strategy: Focus on advancing VK2735 in both subcutaneous and oral formulations for obesity treatment, with a unique approach of using the same molecule for both formulations to reduce safety risks during transitions.

Maintenance Dosing Study: Initiated a Phase I study to evaluate maintenance dosing strategies for VK2735, including monthly subcutaneous, weekly oral, and daily oral dosing. Results expected in mid-2026.

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Risk or Challenges

Increased R&D Expenses: Research and development expenses increased significantly to $90 million for Q3 2025 compared to $22.8 million in Q3 2024, primarily due to clinical studies, manufacturing, and regulatory services. This could strain financial resources and impact profitability.

Net Loss: The company reported a net loss of $90.8 million for Q3 2025, a significant increase from $24.9 million in Q3 2024. This reflects higher operational costs and could challenge financial sustainability.

Cash Burn Rate: Cash, cash equivalents, and short-term investments decreased from $903 million at the end of 2024 to $715 million as of September 30, 2025. This indicates a high cash burn rate, which could limit future operational flexibility.

Regulatory Risks: The company is advancing multiple clinical trials and plans to submit regulatory filings, including an end of Phase II meeting request to the FDA. Delays or unfavorable outcomes in regulatory processes could impact timelines and strategic objectives.

Adverse Events in Clinical Trials: While VK2735 was generally well tolerated, treatment-emergent adverse events, particularly gastrointestinal issues, were reported. These could pose risks to patient compliance and the drug's market acceptance.

Enrollment Challenges: The VANQUISH-1 and VANQUISH-2 Phase III trials require large patient enrollments (4,500 and 1,100 participants, respectively). Delays in enrollment could impact trial timelines and subsequent product launches.

Dependence on VK2735: The company’s pipeline heavily relies on the success of VK2735. Any setbacks in its development or commercialization could significantly impact the company’s strategic goals.

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Guidance & Outlook

Phase III VANQUISH Registration Program: The VANQUISH program includes two trials evaluating VK2735 in adults with obesity and adults with obesity and type 2 diabetes. Each trial is designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. Enrollment for VANQUISH-1 is expected to complete by the end of 2025, and VANQUISH-2 by Q1 2026.

Oral Formulation of VK2735: The company plans to submit an end of Phase II meeting request to the FDA in Q4 2025 to discuss next steps for the oral formulation of VK2735. The oral formulation has shown statistically significant weight loss results and is being positioned as a potential maintenance therapy.

Phase I Maintenance Dosing Study: A Phase I study has been initiated to evaluate maintenance dosing regimens for VK2735, including monthly subcutaneous doses, weekly oral doses, and daily oral doses. Results are expected in mid-2026.

Amylin Receptor Agonist Program: The company plans to file an IND for its novel amylin receptor agonist in Q1 2026, with Phase I studies to follow.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:Enrollment is going well in Phase III. Are there any early signs of patient persistence or discontinuation rates?

A:Enrollment is ahead of schedule, reflecting enthusiasm for the program. There are no notable persistence issues or discontinuation rates observed so far.

Q:Can you expand on the 19-week induction versus 12-week maintenance in the maintenance study? What is being done during the induction phase, and how are patients being titrated?

A:Patients are titrated up to doses of 17.5 mg, 20 mg, or 22.5 mg during the induction phase before transitioning to monthly dosing. The titration windows are slightly accelerated compared to the 4-week blocks in the Phase III study.

Q:Are there any changes to the tablets or the availability of an auto-injector for the maintenance study?

A:No auto-injector is available; the study uses vial and syringe forms. Tablets are smaller, with doses of 17.5 mg, 27.5 mg for dailies, and 110 mg for weekly.

Q:What are the doses being tested for the monthly subcutaneous, daily oral, and weekly oral regimens in the maintenance study?

A:Monthly doses range from 15 mg to 22.5 mg. Daily oral doses are 17.5 mg and 27.5 mg, and the weekly oral dose is 110 mg.

Q:Why are the 19-week doses higher than those tested in Phase III?

A:The higher doses are being tested to explore the optimal monthly dose, as the correct dose is not yet known.

Q:What are the key considerations when screening for multiple compounds? Will the compounds be small molecules, peptides, subcutaneous, or orally dosed?

A:Key considerations include efficacy, toxicity profile, and compatibility with 2735. The lead compound is a peptide, and formulation challenges are addressed early in development.

Q:If the maintenance study shows compelling evidence, what is the next clinical step for validating a maintenance regimen?

A:The next step could involve a longer study, such as a Phase IIb or Phase III, to validate the maintenance regimen and potentially include it in the label.

Q:Has the government shutdown impacted enrollment for the VANQUISH studies or the timing of the amylin program?

A:No impact on enrollment or communication with the FDA has been observed. However, the timing of an end-of-Phase II meeting could be affected.

Q:For the daily maintenance regimen, will there be titration from 17.5 mg to 27.5 mg?

A:No titration is planned from 17.5 mg to 27.5 mg, as subcutaneous exposures are much higher than oral, making titration unnecessary.

Q:When transitioning from weekly injectable to weekly oral at 110 mg, is titration necessary?

A:Titration is not anticipated, and no significant tolerability challenges are expected.

Q:How can the maintenance data be leveraged given the lack of a regulatory path to include it on the label?

A:The data can be used to engage payers by demonstrating the importance of persistence for long-term clinical benefits and cost savings.

Q:What are your thoughts on the recent Pfizer-Metsera deal?

A:No comments were provided on the deal, as it is better addressed by Pfizer or Metsera management.

Q:Will there be a decision on proceeding to Phase IIb or Phase III for the oral program by the end of the year?

A:The decision depends on the FDA meeting and the timing of receiving final minutes, which could extend into January.

Q:What lessons have been learned from recent dynamics in the oral GLP-1 space?

A:The program's safety and tolerability profiles are strong. Lessons include starting at lower doses and extending titration windows for better long-term outcomes.

Q:What are the limiting steps for the DACRA IND filing?

A:Efforts are focused on understanding whether the compound is better suited for oral therapy due to its potency, which could allow for low-dose oral administration.

Q:What topics will be discussed in the end-of-Phase II meeting for the oral program?

A:Discussions will include study design, duration, safety package, and leveraging subcutaneous safety data for the oral program.

Q:Are there plans for additional studies, such as head-to-head comparisons with current GLP-1s?

A:No additional Phase III studies are planned, but expected studies include renal and hepatic impairment studies and drug-drug interaction studies.

Q:What are the expectations for OpEx spend moving forward?

A:OpEx is expected to remain at higher levels due to Phase III activities, with some variability by quarter.

Q:Are there plans to partner VK2809 in the MASH space?

A:There is increased interest in the MASH space, and the company is in a strong position with valuable assets, but no specific plans were disclosed.

Q:Will the next oral study be oral-to-oral or subcutaneous-to-oral?

A:The next oral study will likely be a traditional design with titration to a level and maintenance for 52 weeks.

Q:Will data from VANQUISH-1 and VANQUISH-2 be reported simultaneously or sequentially?

A:The decision depends on the timing of data availability. If there is a significant time gap, the data will likely be reported separately.

Q:When will updates on the Phase IIa or Phase I oral studies be available?

A:The final PK report from the oral dosing study is expected within the next few weeks.

Q:What are your thoughts on the dose required for maintaining weight loss during active weight loss versus after reaching maximum weight loss?

A:The goal is to understand what dose prevents weight regain, regardless of whether patients have reached maximum weight loss.

Q:What is your interpretation of Eli Lilly's cardiovascular outcomes in type 2 diabetes?

A:The full results are not yet available, but larger weight loss and A1C reductions are expected to translate into cardiovascular benefits.

Q:What is your latest thinking on partnerships or going alone for commercialization in the obesity field?

A:The company is open to partnerships but is also prepared to proceed independently if necessary.

Q:Review of Unclear Management Responses

A:Management avoided directly commenting on the Pfizer-Metsera deal, stating it is better addressed by the respective companies. Additionally, they did not disclose specific dose levels for the next oral study or provide a clear timeline for the DACRA IND filing.

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Earnings Word Cloud

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