Viking Therapeutics, Inc. (VKTX)·Q2 2024 Earnings Summary

Executive Summary

• Pre-revenue quarter with disciplined OpEx and higher interest income: net loss was $22.3M ($0.20/share) vs $27.4M ($0.26/share) in Q1 and $19.2M ($0.19/share) a year ago; R&D of $23.8M and G&A of $10.3M reflected manufacturing, clinical and personnel costs .
• Obesity franchise advanced: FDA Type C feedback enables VK2735 (subcutaneous) to proceed to Phase 3; End-of-Phase 2 (EoP2) meeting planned in 2H24; monthly dosing to be explored in future study based on PK profile .
• Oral VK2735 continued to derisk: dose escalation completed through 80 mg and 100 mg cohort ongoing; 13-week Phase 2 in obesity targeted to begin in 4Q24 .
• NASH program strengthened: VOYAGE 52-week biopsies showed best-in-class histology—NASH resolution up to 75% vs 29% placebo and ≥1-stage fibrosis improvement up to 57% vs 34% placebo; EoP2 meeting planned for 4Q24 .
• Balance sheet supports aggressive execution: cash, cash equivalents and short-term investments of $942M at 6/30/24; management estimates ~$300M for the subcutaneous VK2735 Phase 3 registration program .

What Went Well and What Went Wrong

• What Went Well

  • Regulatory de-risking and path to pivotal: “Based on written feedback from the agency, we intend to advance VK2735 into Phase III development for obesity,” with an EoP2 meeting planned in 2H24 .
  • Strong VK2809 52-week histology: NASH resolution 63–75% vs 29% placebo and fibrosis improvement 44–57% vs 34% placebo; safety largely mild/moderate AEs, balanced discontinuations vs placebo .
  • Liquidity to self-fund major milestones: “the company ended the quarter with a strong balance sheet of $942 million” enabling key pipeline execution .

• What Went Wrong

  • Higher OpEx YoY as programs scale: R&D rose to $23.8M (from $13.9M) and G&A to $10.3M (from $9.8M) on manufacturing, clinical and staffing; net loss modestly widened YoY to $22.3M from $19.2M .
  • No financial guidance; Street comparisons unavailable: company did not issue quantitative guidance; S&P Global consensus was unavailable at query time, limiting beat/miss analysis .
  • VK0214 timing pushed to 2H: Phase 1b AMN readout guided to 2H24 vs prior “mid-2024,” indicating a modest delay in that rare disease program’s cadence .

Financial Results

Cash and investments

• Cash, cash equivalents and short-term investments: $362.1M (12/31/23) → $963M (3/31/24) → $942M (6/30/24) .

Segment breakdown: Not applicable (no commercial revenue) .

Key KPIs (clinical efficacy and safety)

• VK2735 (SC, Phase 2, 13 weeks): up to 14.7% mean weight loss from baseline; up to 13.1% vs placebo; GI AEs largely mild/moderate (95% of GI AEs mild/moderate) .
• VK2735 (Oral, Phase 1, 28 days): up to 5.3% mean weight loss from baseline; up to 3.3% vs placebo; no vomiting; diarrhea 3% VK2735 vs 20% placebo; all TEAEs mild/moderate .
• VK2809 (Phase 2b VOYAGE, 52 weeks): NASH resolution 63–75% vs 29% placebo; fibrosis improvement 44–57% vs 34% placebo; both endpoints 40–50% vs 20% placebo; 94% of treatment-related AEs mild/moderate .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “The first half of 2024 was marked by strong momentum… we reported successful outcomes from three different clinical trials… we are advancing [VK2735] into Phase 3 development… [and] plan to schedule an end of Phase 2 meeting with the FDA later this year.” — Brian Lian, CEO .
• “To support Viking’s maturing pipeline, the company ended the quarter with a strong balance sheet of $942 million, providing the runway to execute key milestones for each of our pipeline programs.” — Brian Lian .
• “Based on written feedback from the agency, we intend to advance VK2735 into Phase III development for obesity… plan to schedule an end of Phase II meeting… in the fourth quarter of this year.” — Brian Lian (call) .
• “The Phase III registration program for subcu would be around $300 million, in forming the guidance.” — Greg Zante, CFO (call) .
• “The PK profile does suggest that monthly is feasible. We won't know until we actually do a study.” — Brian Lian (call) .

Q&A Highlights

• Phase 3 scope and cost: FDA guidance implies two Phase 3 studies, ≥4,500 total patients with ≥3,000 exposed; estimated ~$300M for the subcutaneous registration program .
• Supply/manufacturing: Company has sufficient API and supply to complete planned trials for both formulations; CapEx needs primarily at CDMOs, not Viking .
• Oral VK2735 dose escalation: Tolerability remains “very encouraging” through 80 mg; 100 mg cohort ongoing; blinded to weight-change data; stepwise titration (e.g., 60→80 mg) used in cohorts .
• Monthly dosing rationale: Supported by half-life (~180 hours); tolerability expected to be manageable if maintaining therapeutic range; study design still in development .
• Partnerships: Receptive to BD; NASH program preference to partner with a larger party on registration path; obesity moving aggressively in-house .

Estimates Context

• S&P Global consensus for Q2 2024 revenue and EPS was unavailable at the time of query due to API request limits; as such, we cannot provide a beat/miss assessment versus Street for the quarter .
• Company reported GAAP net loss of $22.3M ($0.20/share) and zero revenue; no non-GAAP adjustments were provided in the press release or call materials .

Key Takeaways for Investors

• Phase 3 for VK2735 (SC) is now the base case with an EoP2 meeting in 2H24; design specifics (doses, titration, potential monthly arm) are catalysts that can influence perceived competitiveness vs. peers .
• Oral VK2735 remains a differentiated lever (transition option from SC; maintenance strategy); Phase 2 start in 4Q24 creates an additional readout stream and potential valuation support .
• VK2809 delivered best-in-class 52-week histology signals with a benign GI profile; the 4Q24 EoP2 meeting will define the registration path and partnering optionality in NASH .
• Funding is adequate to execute: $942M cash and investments vs an estimated ~$300M for the subcutaneous Phase 3 program suggests runway to advance multiple assets without near-term financing .
• Upcoming catalysts likely to move the stock: EoP2 meeting outcomes (VK2735 SC in 2H24; VK2809 in 4Q24), ObesityWeek oral VK2735 update (incl. 100 mg cohort if available), oral Phase 2 initiation in 4Q24, and VK0214 Phase 1b AMN data in 2H24 .
• Strategic flexibility remains: management open to partnerships, particularly in NASH, while retaining control of obesity—offering multiple routes to value realization .
• Risk frame: Execution risk across parallel programs (large Phase 3 scope, manufacturing scale-up) and timelines (e.g., slight VK0214 delay) should be monitored, but regulatory momentum and cash buffer help mitigate .

Financial and Clinical Detail (Supporting Tables)

Performance vs prior periods and estimates (where available)

Clinical KPIs (select)

Why results moved

• Sequential narrowing of net loss (Q2 vs Q1) driven by higher interest income ($11.8M vs $6.7M) despite stable OpEx (both ~$34M) .
• YoY OpEx growth reflects manufacturing scale-up, clinical/preclinical activity, and personnel costs as programs advance toward late-stage development .

Sources

• Q2 2024 press release and 8-K: financials, pipeline updates, and balance sheet .
• Q2 2024 earnings call: strategy, Phase 3 plan and costs, dosing cadence, supply, BD .
• VK2809 52-week histology press release (June 4, 2024): detailed efficacy and safety .
• Q1 2024 press release: prior-quarter financials and pipeline baselines .
• Q4 2023 8-K: historical baselines and context .