Viking Therapeutics, Inc. (VKTX) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call indicates mixed signals: increased net loss due to R&D costs, but a promising pipeline with Phase III trials and a new amylin program. The Q&A reveals management's reluctance to disclose specifics, which raises uncertainties. Despite strong cash reserves, the lack of clear guidance and strategic partnerships tempers optimism. Overall, the sentiment remains neutral as positive developments are balanced by uncertainties and financial pressures.
Key Financial Performance
Research and Development Expenses (Q4 2025) $153.5 million, a significant increase from $31 million in Q4 2024. The increase was primarily due to expenses related to running 2 Phase III clinical trials, stock-based compensation, and salaries and benefits, partially offset by decreased expenses related to manufacturing for drug candidates and preclinical studies.
General and Administrative Expenses (Q4 2025) $11.3 million, a decrease from $15.3 million in Q4 2024. The decrease was primarily due to reduced expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation.
Net Loss (Q4 2025) $157.7 million or $1.38 per share, compared to $35.4 million or $0.32 per share in Q4 2024. The increase in net loss was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income.
Research and Development Expenses (Full Year 2025) $345 million, a significant increase from $101.6 million in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for drug candidates, stock-based compensation, salaries and benefits, regulatory services, and consultants, partially offset by decreased expenses related to preclinical studies.
General and Administrative Expenses (Full Year 2025) $48.4 million, a slight decrease from $49.3 million in 2024. The decrease was primarily due to reduced expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation, insurance, and salaries and benefits.
Net Loss (Full Year 2025) $358.5 million or $3.19 per share, compared to $110 million or $1.01 per share in 2024. The increase in net loss was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income.
Cash, Cash Equivalents, and Short-term Investments (End of 2025) $706 million, a decrease from $903 million at the end of 2024. The decrease reflects the company's expenditures on research and development and other operational activities.
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Operating Highlights
VK2735 Subcutaneous Formulation: Initiated Phase III VANQUISH clinical program in obesity, including two studies (VANQUISH-1 and VANQUISH-2). VANQUISH-1 completed enrollment ahead of schedule, and VANQUISH-2 is nearing completion. Demonstrated significant weight loss in Phase I and II studies.
VK2735 Oral Formulation: Completed Phase II VENTURE oral dosing study with positive results, achieving primary and secondary endpoints. Plans to advance into Phase III development in Q3 2026.
Amylin Agonist Program: Progressed with novel agonists of the amylin receptor for appetite and weight regulation. IND filing expected later this quarter.
Market Expansion for VK2735: Potential to introduce industry's first oral and subcutaneous therapeutic options using the same dual GLP-1 and GIP coagonist molecule. Manufacturing agreement with CordenPharma to support commercialization.
Manufacturing and Supply Agreement: Signed agreement with CordenPharma for large-scale supply of active pharmaceutical ingredients and fill/finish capacities for VK2735 formulations.
Staffing and Leadership: Increased staffing in clinical, supply chain, and manufacturing roles. Appointed Neil Aubuchon as Chief Commercial Officer to lead commercial strategy.
Pipeline Diversification: Expanded pipeline with VK2735 and amylin agonist programs, focusing on weight loss and obesity treatment.
Financial Management: Maintained over $700 million in cash to support ongoing Phase III trials and other development programs.
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Risk or Challenges
Increased R&D Expenses: The company reported a significant increase in research and development expenses, rising from $101.6 million in 2024 to $345 million in 2025. This increase is attributed to clinical studies, manufacturing, and regulatory services, which could strain financial resources and impact profitability.
Net Loss: Viking reported a net loss of $358.5 million in 2025, a substantial increase from $110 million in 2024. This growing loss could challenge the company's financial sustainability and ability to fund future operations.
Cash Reserves Decline: The company's cash reserves decreased from $903 million in 2024 to $706 million in 2025. This decline, coupled with high R&D expenses, could limit financial flexibility and increase reliance on external funding.
Regulatory Risks: The development of VK2735 and other programs is subject to regulatory approvals, including ongoing Phase III trials and FDA feedback. Delays or negative outcomes in these processes could hinder product commercialization.
Adverse Events in Clinical Trials: While VK2735 showed promising results, treatment-emergent adverse events, primarily gastrointestinal issues, were reported. These could impact patient adherence and the drug's market acceptance.
Supply Chain Dependence: The company relies on CordenPharma for large-scale manufacturing and supply of VK2735. Any disruptions in this partnership could affect production and commercialization timelines.
Competitive Pressures: The obesity treatment market is highly competitive, with other companies launching oral peptides and weight-loss therapies. Viking's ability to differentiate its products and capture market share remains uncertain.
Strategic Execution Risks: The company is expanding its pipeline and commercial activities, including the introduction of an auto-injector and oral formulations. Missteps in execution could delay product launches or reduce market impact.
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Guidance & Outlook
Phase III VANQUISH Program: The Phase III VANQUISH program includes two studies: VANQUISH-1 (targeting adults with obesity) and VANQUISH-2 (targeting adults with obesity and type 2 diabetes). VANQUISH-1 has completed enrollment ahead of schedule, while VANQUISH-2 is nearing completion. Both studies aim to assess the efficacy and safety of VK2735 administered weekly for 78 weeks, with primary endpoints focused on percent change in body weight from baseline.
Oral VK2735 Phase III Development: The company plans to advance oral VK2735 into Phase III development for obesity, with initiation expected in the third quarter of 2026. Study design details will be provided in the coming months.
Maintenance Dosing Study: A Phase I study evaluating various maintenance dosing regimens (monthly, weekly, every other week subcutaneous doses, and weekly or daily oral doses) has completed enrollment. Results are expected in the third quarter of 2026.
Amylin Agonist Program: The company expects to file an IND for its lead amylin agonist program in the first quarter of 2026, targeting appetite and body weight regulation.
Commercial Preparation: Viking has signed a manufacturing agreement with CordenPharma to support large-scale production of VK2735, enabling potential multibillion-dollar revenue opportunities. The company has also appointed a Chief Commercial Officer to lead its commercial strategy.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Will there be a Phase III study in patients with diabetes, and has the FDA provided feedback on improving nausea rates?
A:The company is not disclosing specifics of FDA communication but feels comfortable transitioning into Phase III. Details on design elements will be shared closer to launch, likely paralleling the VANQUISH-1 and VANQUISH-2 design.
Q:Does the evolving obesity space influence the go-to-market strategy, and will the company partner with firms like Ro or Hims?
A:The company is exploring various options but is not disclosing its strategy at this time. They acknowledge the rapidly evolving market and aim to adapt their strategy accordingly. They have sufficient cash to cover major catalysts, including the oral Phase III trials.
Q:Will the design of the tablet in Phase III differ from the Phase IIa program?
A:Yes, the tablet size and count will be reduced in the Phase III program based on learnings from Phase II.
Q:What does success look like for the maintenance study, and will there be a subcu arm in the Phase III trial?
A:Success is defined as continued weight loss, weight stabilization, or minimal rebound during the maintenance period. The company is considering creative options for the maintenance window but has not finalized plans for a subcu arm in the Phase III trial.
Q:Why was the 15 mg once-monthly dose split into a bi-weekly dose in the Phase I maintenance study?
A:The decision was based on feedback from investigators and market research favoring less frequent regimens. The adjustment allows for testing a lower bi-weekly maintenance dose.
Q:Will there be one or two Phase III trials, and will the size of the trials be reduced?
A:There will likely be two separate studies for diabetes and non-diabetes patients. The size of the oral Phase III program may be reduced by leveraging data from the subcu program.
Q:Will the duration of the oral Phase III trial be shorter than the VANQUISH study, and is there any data needed before starting the trial?
A:The oral Phase III trial may have a shorter duration, reduced size, and fewer clinic visits. No additional data is needed before starting the trial in Q3.
Q:Can the maintenance study provide insights into oral tolerability?
A:The company expects good tolerability for the oral dose, as it follows higher subcu doses with lower exposures. Significant GI side effects are not anticipated.
Q:Has the FDA agreed on patient numbers and duration for the oral Phase III trial, and is supply for the trial ready?
A:The company feels comfortable with the FDA's feedback on the clinical development plan. Supply for the trial is not expected to be an issue.
Q:What is the status of the auto-injector and the amylin program?
A:The auto-injector bioequivalence study was positive, and it will be introduced this quarter. The amylin program's IND will be filed this quarter, with first dosing likely in Q2 and initial data expected later in 2026.
Q:What are the read-throughs from Novo's oral Wegovy uptake, and is the current R&D spend sustainable?
A:The rapid uptake of oral Wegovy is seen as positive for oral peptides. Quarterly R&D spend is expected to range between $60 million and $90 million.
Q:Are there notable differences in baseline characteristics for the maintenance study, and what are the expectations for the amylin program?
A:Baseline characteristics are expected to be similar to the VENTURE Phase II study. The amylin program will likely be U.S.-based, with initial data from the SAD portion expected later in 2026.
Q:Will a larger maintenance study be needed, and are there supply issues with the auto-injector?
A:A larger maintenance study may be required, depending on the data. No supply issues are anticipated for the auto-injector.
Q:Were there differences in the end-of-Phase II meeting minutes for oral and injectable VK2735, and will the maintenance study use auto-injectors?
A:Feedback from the FDA was consistent for both oral and injectable VK2735. The maintenance study will not use auto-injectors.
Q:Review of Unclear Management Responses
A:Management avoided providing direct answers to several questions, including specifics on FDA feedback for nausea rates, the go-to-market strategy, and the inclusion of a subcu arm in the Phase III trial. They also did not disclose details about the end-of-Phase II meeting minutes or the exact design elements of the Phase III studies.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Chief Commercial
Commercial Officer
CordenPharma commercialization
CordenPharma scale
FDA step
III VANQUISH
Ms Inc
Officer role
Phase III
Relations Ms
VANQUISH Enrollment
VANQUISH completion
VANQUISH program
VANQUISH treatment
VK effect
VK efficacy
Viking manufacturing
Viking milestone
adult obesity
agreement CordenPharma
agreement supply
appointment Chief
benefit manufacturing
chain manufacturing
compensation month
completion respect
decrease patent
development comment
development milestone
diabetes completion
dollar opportunity
dosing study
period decrease
result Research
service stock
today Viking
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VKTX Transcript
Viking Therapeutics, Inc. (VKTX) Q4 2025 Earnings Call Transcript
Unknown2-12
The earnings call indicates mixed signals: increased net loss due to R&D costs, but a promising pipeline with Phase III trials and a new amylin program. The Q&A reveals management's reluctance to disclose specifics, which raises uncertainties. Despite strong cash reserves, the lack of clear guidance and strategic partnerships tempers optimism. Overall, the sentiment remains neutral as positive developments are balanced by uncertainties and financial pressures.
Viking Therapeutics, Inc. (VKTX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Neutral1-13
Viking Therapeutics, Inc. (VKTX) Presents at Jefferies London Healthcare Conference 2025 Transcript
Neutral11-19
Viking Therapeutics, Inc. (VKTX) Q3 2025 Earnings Call Transcript
Positive10-22
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.
VKTX Report
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