Viking Therapeutics, Inc. Q4 FY2024 earnings call

• Brian Lian highlighted 2024 was a busy year with successful results from four pipeline studies: VK2735 subcutaneous and oral obesity programs, VK2809 NASH/fibrosis program, and VK0214 X-ALD program. • VK2735 lead obesity program had positive Phase 2 VENTURE trial results, Phase 1 oral tablet study showed good tolerability and weight loss. Plans to initiate Phase 3 trials for subcutaneous in Q2 2025 and VENTURE-Oral Dosing trial results expected in H2 2025. • VK2809 NASH program had final 52-week study results, completed end-of-Phase 2 meeting with FDA. • VK0214 X-ALD program had positive Phase 1b results showing safety, tolerability, and reduced very long chain fatty acids. • Amylin receptor agonist program announced in 2024, expect IND filing and Phase 1 trial later in 2025. • Strong balance sheet with over $900M cash as of Dec 31, 2024, providing runway for development.

No specific product segment financial performance with revenue contribution % provided as the transcript does not detail revenue by product segments.

• Plan to initiate Phase 3 trials evaluating subcutaneous VK2735 for obesity in Q2 2025. • Expect to report data from the ongoing Phase 2 VENTURE-Oral Dosing trial in H2 2025. • Plan to file IND for novel amylin agonist program later in 2025. • Phase 3 programs will conform to guidance requiring at least 4,500 people, with 52-week treatment window and multiple doses.

• Forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from expectations, as mentioned in the opening remarks.

Q: Ryan Deschner asked about feedback from end of Phase 2 meeting and Phase 3 study details.

A: Brian Lian said Phase 3 studies will conform to guidance requiring at least 4,500 people, with one in obese subjects and one in type 2 diabetes, targeting 52-week window and multiple doses, with further details to come on initiation.

Q: Mike Ulz asked about timing of Phase 3 obesity study start.

A: Brian Lian said it's primarily logistical, with better visibility on clinical material production allowing better timing, but everything on track.

Q: Asim Rana asked about Phase 3 study nature, patient recruitment, and API.

A: Brian Lian said primary endpoint is body weight change, diabetes study includes glycemic endpoints; recruitment timeline not yet available; have API for both studies and hope to start concurrently.

Q: Jay Olson asked about monthly testing for subcu formulation and transition from subcu to oral.

A: Brian Lian said study to evaluate weight regain by transitioning from weekly to monthly dosing; transition from subcu to oral ideally in same study, working on protocol.

Q: Annabel Samimy asked about Phase 2 oral VENTURE trial dose range and manufacturing.

A: Brian Lian said dose range TBD, Phase 1 study well tolerated at 100mg, working on manufacturing agreements with progress but details to come later.

Q: Mayank Mamtani asked about 13-week weight loss expectation, COGS, and weight regain/lean muscle.

A: Brian Lian said 13-week weight loss expectation too early to tell; COGS premature to discuss; maintenance study to target weight regain, Dexas in Phase 3 for some patients.

Q: Biren Amin asked about monthly subcu dose study and amylin IND.

A: Brian Lian said dose details to come on study initiation; hope to have IND-enabling work done for amylin program this year.

Q: Hardik Parikh asked about subcu program type 2 diabetes inclusion and oral program data timing.

A: Brian Lian said Phase 3 trial in obese subjects and separate in type 2 diabetes, with data released when key elements available; oral program data released when top line available.

Q: Andy Hsieh asked about PK data and follow-up on accumulation.

A: Brian Lian said plasma levels in 2.5mg dose range prevent weight gain, accumulation graph shows ongoing accumulation even at fixed dose, suggesting 13-week data understate long-term efficacy.

Q: Yale Jen asked about Phase 3 type 2 diabetes label and auto injector.

A: Brian Lian said type 2 diabetes inclusion in obesity label, plan to introduce auto-injector with bridging study.

Q: Justin Zelin asked about peptide vs small molecule scalability.

A: Brian Lian said peptide chemistry simple, scalability challenge, but confident in producing scale for multibillion-dollar franchise.

Q: Unidentified Analyst asked about amylin program compound characterization.

A: Brian Lian said selected compounds are balanced, close to one-to-one calcitonin to amylin ratio.