Viking Therapeutics, Inc. Q3 FY2026 earnings call

• Lead Program (VK2735) Progress: Both subcutaneous (Vanquish program) and oral (Sunrise program) Phase III trials for the dual GLP-1/GIP agonist VK2735 are active. Vanquish 1 and 2 are fully enrolled and advancing toward completion. The Sunrise Phase III program, evaluating oral formulations in adults with obesity and type 2 diabetes, was initiated earlier this month.
• Maintenance Dosing Breakthrough: Positive results were announced from Part 1 of a maintenance dosing study, demonstrating that participants could maintain significant weight loss (82-97% retained at week 33) using every-other-week or monthly subcutaneous dosing schedules after an induction phase. Tolerability during maintenance was comparable to placebo.
• New Maintenance Study Initiation: Part 2 of the maintenance study has begun to evaluate daily oral maintenance doses alongside additional subcutaneous regimens (every other week and monthly). Results are expected in 2027.
• Pipeline Expansion (VK3019): Advancement of VK3019, a novel amylin/calcitonin receptor agonist, continues. A Phase I single ascending dose study is nearing completion, with a multiple ascending dose study planned for Q1 2027.
• Commercial Preparation: Management highlighted the strengthening of the commercial infrastructure, including the hiring of senior leadership in commercial, market access, medical affairs, and operational roles in tech ops, CMC, supply chain, and quality/compliance.
• Financial Position: The company closed concurrent offerings of common stock and convertible notes, raising approximately $575 million in gross proceeds. Cash, cash equivalents, and short-term investments stood at $960 million as of September 30, 2026.

As a clinical-stage biotechnology company focused on obesity treatments, Viking Therapeutics does not report revenue from product sales. Consequently, there are no financial performance figures or revenue contribution percentages for product segments. The company reported operating expenses driven by research and development and general/administrative activities.

• Clinical Milestones: Management expects the completion of the Vanquish Phase III studies and the reporting of top-line data in the second half of 2027. The Part 2 maintenance study and the VK3019 multiple ascending dose study are also targeted for readouts or initiation in 2027.
• Regulatory Strategy: While specific filing dates are not confirmed, management indicated a strong preference for incorporating maintenance dosing data into the initial New Drug Application (NDA) label if feasible, though it remains more likely to be submitted as a supplement later due to data set size and timing constraints.
• Financial Outlook: No specific forward-looking revenue or earnings guidance was provided. However, management noted that General and Administrative (G&A) expenses are expected to remain relatively flat in the near term before potentially increasing closer to commercialization, while Research and Development (R&D) expenses will continue to rise due to ongoing Phase III trial costs.

• Clinical Trial Risks: Potential for adverse events, discontinuations, or lack of efficacy in Phase III trials despite positive Phase II data. Blinded discontinuation rates are currently tracking within expectations, but long-term safety and tolerability remain key uncertainties.
• Development Timeline Risks: Delays in completing Phase III trials, maintenance studies, or VK3019 development could impact the timeline for potential launch and revenue generation.
• Competitive Landscape: Intense competition in the obesity treatment space, with competitors releasing data showing high efficacy. Viking must differentiate its portfolio through formulation flexibility (oral vs. injectable) and dosing frequency.
• Execution Risk: Successful commercial launch depends on building out supply chain, manufacturing, and commercial teams effectively. Any failure in these operational preparations could hinder market entry.
• Regulatory Uncertainty: FDA approval is not guaranteed, and the inclusion of maintenance dosing claims in the initial label remains subject to regulatory dialogue and review.

Q: Analyst asked about key differentiators of VK2735 against competitors like Zepbound and whether cross-trial comparisons should be made. / A: CEO Brian Lian highlighted two main differentiators: having both subcutaneous and oral formulations of the same molecule (potentially the first approved dual GLP-1/GIP oral option) and flexible dosing schedules (weekly, every other week, or monthly). He cautioned against direct cross-trial comparisons, stating the data should stand on its own merits.

Q: Analyst inquired about the progress of the commercial build-out and staffing gaps ahead of the potential 2027 launch. / A: CFO Greg Zante and CEO Brian Lian described a solid core commercial team, including SVPs for commercial, market access, and medical affairs. They emphasized recent hires in less visible but critical areas such as tech ops, CMC, supply chain, and quality/compliance to prepare for commercialization.

Q: Analyst asked why the Phase III Sunrise oral study uses a narrower dose range (up to 55 mg) compared to the wider Phase II range (up to 120 mg), and about the VK3019 profile. / A: CEO Brian Lian explained the dose selection balances reducing tablet burden/pill count with ensuring economic viability and sufficient gross margins for profitability. Regarding VK3019, he noted preclinical primate data showed promising potency and that they expect to see interesting signals from the upcoming multiple ascending dose study in Q1 2027.

Q: Analyst asked if the maintenance data from Part 1 or the Vanquish extension studies would be included in the initial NDA filing or submitted later as a supplement. / A: CEO Brian Lian stated it is 'TBD' but leaned towards it being a supplement later because the Vanquish extension data will be a larger, longer dataset. However, they prefer including it in the initial label if regulatory discussions allow, aiming for a robust dataset to support marketing claims.

Q: Analyst asked about the rationale for excluding weekly oral maintenance in Part 2 of the maintenance study and the potential for VK2735/VK3019 combination therapy. / A: CEO Brian Lian explained that high single-dose variability with oral administration makes daily dosing harder to optimize for maintenance, so resources were focused on daily oral and various sub-Q regimens. For VK3019, he identified combination therapy with VK2735 as the most obvious opportunity due to non-overlapping mechanisms, while also seeing monotherapy value for patients intolerant to GLP-1s.