Viking Therapeutics(VKTX) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $90 million, up from $22.8 million in Q3 2024, primarily due to increased clinical study costs and salaries [9] - General and administrative expenses decreased to $8.6 million in Q3 2025 from $13.8 million in Q3 2024, mainly due to reduced legal and patent service costs [9] - The net loss for Q3 2025 was $90.8 million or $0.81 per share, compared to a net loss of $24.9 million or $0.22 per share in Q3 2024 [10] - For the first nine months of 2025, research and development expenses totaled $191.5 million, up from $70.7 million in the same period of 2024 [11] - The net loss for the first nine months of 2025 was $202 million or $1.80 per share, compared to a net loss of $74.5 million or $0.69 per share in the same period of 2024 [11] - Cash, cash equivalents, and short-term investments were $715 million as of September 30, 2025, down from $903 million at the end of 2024 [12] Business Line Data and Key Metrics Changes - The company is advancing VK2735, a dual agonist for obesity treatment, with both subcutaneous and oral formulations [13] - The phase two clinical trial of VK2735's oral tablet formulation achieved significant weight loss results, with reductions up to 12.2% from baseline after 13 weeks [20][21] - The subcutaneous formulation demonstrated up to 8% weight loss after 28 days in prior studies, indicating strong efficacy [14] Market Data and Key Metrics Changes - The Vanquish Registration Program for VK2735 is targeting enrollment of approximately 4,500 patients for one trial and 1,100 patients for another, with enrollment proceeding well [17][18] - The company plans to submit an end-of-phase two meeting request to the FDA to discuss next steps for the oral formulation of VK2735 [24] Company Strategy and Development Direction - The company is focused on advancing its obesity treatment programs and exploring maintenance dosing strategies for VK2735 [26] - Viking Therapeutics is also developing novel agonists targeting the amyloid receptor, with an IND filing expected in Q1 2026 [27] - The company aims to manage its balance sheet effectively to support multiple value inflection points [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the enrollment progress in the Vanquish studies and noted no early signs of patient persistence issues [33] - The company is exploring various maintenance dosing regimens to enhance patient adherence and long-term outcomes [65] - Management remains open to partnerships for commercialization but is also prepared to proceed independently [117] Other Important Information - The company highlighted the importance of maintaining weight loss and preventing regain through effective dosing strategies [110] - Management discussed the potential impact of recent developments in the oral GLP-1 space on their program, emphasizing their strong safety and tolerability profile [76] Q&A Session Summary Question: Early signs of patient persistence in the Vanquish studies - Management noted that enrollment is ahead of schedule and there are no notable persistence issues at this early stage [33] Question: Details on the maintenance study's induction phase - The induction phase will involve titration to doses of 17.5 mg, 20 mg, and 22.5 mg over 19 weeks [34] Question: Doses for the maintenance study - Monthly doses will range from 15 mg to 22.5 mg, with daily doses at 17.5 mg and 27.5 mg [41] Question: Impact of government shutdown on enrollment and timing - Management reported no significant impact from the government shutdown on enrollment or timing of the amyloid program [51] Question: Future clinical steps for maintenance regimens - Management indicated that a longer study may be needed to validate maintenance regimens, potentially a phase two B or phase three [50] Question: Considerations for the end-of-phase two meeting with the FDA - The meeting will focus on study design, duration, and leveraging the safety package from the subcutaneous formulation [83] Question: Expectations for operating expenses moving forward - Operating expenses are expected to remain elevated due to ongoing phase three activities [90] Question: Strategic interest in the metabolic disease space - Management acknowledged increased interest in the MASH space and noted ongoing discussions regarding VK2809 [91]