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 expenses and salaries [6] - 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 [6] - 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 [7][8] - For the first nine months of 2025, research and development expenses totaled $191.5 million, up from $70.7 million in the same period in 2024 [8] - 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 in 2024 [9] Business Line Data and Key Metrics Changes - The company announced positive top-line results from the phase two clinical trial of VK2735, achieving significant weight loss in patients with obesity [4][26] - VK2735 demonstrated statistically significant reductions in body weight, with up to 14.7% weight loss after 13 weeks in the Venture Oral Dosing Study [11][17] - The study also indicated that VK2735 was safe and well-tolerated, with most adverse events being mild or moderate [5][20] Market Data and Key Metrics Changes - The Vanquish Registration Program is currently enrolling approximately 4,500 patients for the obesity trial and 1,100 patients for the obesity and type 2 diabetes trial [13][14] - Enrollment for the Vanquish studies is proceeding well, with expectations to complete enrollment by the end of 2025 for Vanquish One and in Q1 2026 for Vanquish Two [14][25] Company Strategy and Development Direction - The company is advancing both subcutaneous and oral formulations of VK2735 for obesity treatment, aiming to provide options for patients [10][15] - A phase one study has been initiated to evaluate maintenance dosing regimens following initial weight loss achieved with VK2735 [23] - The company is also progressing with novel agonists targeting the amyloid receptor, with an IND filing expected in Q1 2026 [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the enrollment pace in the Vanquish studies, indicating enthusiasm for the program [29] - The company plans to submit an end-of-phase two meeting request to the FDA to discuss potential next steps for the oral formulation of VK2735 [26] - Management noted that the financial position is strong, with $715 million in cash available to support ongoing and future development programs [25] Other Important Information - The company is preparing for potential commercialization strategies, remaining open to partnerships while also being ready to proceed independently [82] - The results from the Venture Oral Dosing Study are expected to be published in a leading medical journal in early 2026 [12] Q&A Session Summary Question: Early signs of patient persistence and trial execution - Management noted that enrollment is ahead of schedule and there are no signs of persistence issues at this early stage [29] Question: Details on the maintenance study induction phase - The induction phase will involve titration up to doses of 17.5 mg, 20 mg, and 22.5 mg over 19 weeks [30] Question: Doses for monthly sub-Q, daily oral, and weekly oral being tested - Monthly doses will range from 15 mg to 22.5 mg, with daily doses at 17.5 mg and 27.5 mg, and weekly oral at 110 mg [34] Question: Next steps for validating a maintenance regimen - Management indicated that a longer study may be needed depending on the data from the maintenance study [38] Question: Impact of government shutdown on enrollment and timing - Management reported no significant impact from the government shutdown on enrollment or communication with the FDA [40] Question: Considerations for leveraging maintenance data with payers - Management emphasized the importance of persistence in therapy and ongoing discussions with payers regarding maintenance options [48] Question: Future plans for VK2809 in the MASH space - Management acknowledged increased interest in the MASH space and noted ongoing discussions regarding VK2809 [66]