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 [8][10] - 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 [9][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 in 2024 [10] - The net loss for the nine months ended September 30, 2025, was $200 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 [10][11] - Cash, cash equivalents, and short-term investments stood at $715 million as of September 30, 2025, compared to $93 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - The company is advancing VK2735, a dual agonist for obesity, with both subcutaneous and oral formulations being developed [12][14] - The Phase II VENTURE oral dosing trial showed statistically significant weight loss reductions of up to 12.2% from baseline after 13 weeks [19][20] - The VANQUISH Phase III program is ongoing, targeting approximately 4,500 patients in one trial and 1,100 in another [15][16] Market Data and Key Metrics Changes - The obesity treatment market is seeing increased interest, with Viking's VK2735 positioned to compete effectively [27][28] - The company is exploring various dosing regimens for VK2735, including monthly subcutaneous and daily oral options [26][29] Company Strategy and Development Direction - Viking is focused on completing its Phase III trials for VK2735 while also pursuing additional programs targeting the amylin receptor [27][28] - The company plans to submit an end of Phase II meeting request to the FDA to discuss next steps for the oral formulation of VK2735 [24][29] - Viking is managing its balance sheet to ensure financial stability for ongoing and future development programs [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing enrollment in the VANQUISH studies and the positive results from the VENTURE oral dosing study [28][29] - The company is prepared to engage with potential partners for commercialization but is also ready to proceed independently if necessary [126] Other Important Information - Viking has seen a significant increase in interest in its NASH asset, reflecting a broader market trend [97] - The company is preparing for potential regulatory discussions regarding its oral formulation and its implications for future studies [88] Q&A Session Summary Question: Early signs of patient persistence in Phase III trials - Management noted that enrollment is ahead of schedule and there are no early signs of persistence issues [34][35] Question: Details on the maintenance study titration - The company is titrating patients up to target doses before transitioning to monthly dosing [36] Question: Monthly doses for maintenance study - Monthly doses will range from 15 mg to 22.5 mg, with daily oral doses at 17.5 mg and 27.5 mg [44] Question: Impact of government shutdown on enrollment - Management reported no significant impact from the government shutdown on enrollment or timelines [54] Question: Future clinical steps for maintenance regimen - Depending on data, the next step could involve a Phase 2b or Phase 3 study to validate the maintenance regimen [51] Question: Expectations for OpEx moving forward - R&D expenses are expected to remain elevated due to ongoing Phase III activities [96] Question: Considerations for the end of Phase II meeting - The focus will be on study design, duration, and leveraging existing safety data for the oral formulation [88] Question: Transitioning from subcutaneous to oral dosing - Management indicated that the oral study would follow a traditional titration approach [103] Question: Strategic interest in metabolic disease space - The company remains open to partnerships but is also prepared to proceed independently [126]