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Viking Therapeutics, Inc. (VKTX)·Q3 2024 Earnings Summary

Executive Summary

  • Viking reported a net loss of $24.9M (-$0.22 EPS) for Q3 2024 versus a net loss of $22.5M (-$0.23 EPS) in Q3 2023, driven by higher R&D and G&A, partially offset by increased interest income .
  • Cash, cash equivalents and short-term investments were $0.93B at quarter-end, providing runway to execute multiple Phase 2/3 milestones across VK2735 (GLP‑1/GIP, injectable and oral), VK2809 (NASH/MASH), and VK0214 (X‑ALD) .
  • Subcutaneous VK2735: End‑of‑Phase 2 FDA meeting scheduled for 4Q24 with intent to advance into Phase 3; management indicated feasibility of monthly maintenance dosing and auto‑injector use in Phase 3 .
  • Oral VK2735: 13‑week Phase 2 obesity study to initiate in 4Q24; Phase 1 dose escalation reached 100 mg with tolerability supporting further development; additional data to be presented at ObesityWeek (Nov 3) .
  • VK2809: VOYAGE Phase 2b histology achieved best‑in‑class endpoints; AASLD oral late‑breaker set for Nov 19; FDA End‑of‑Phase 2 written responses received this week, next steps under evaluation—partnering remains preferred .

What Went Well and What Went Wrong

What Went Well

  • Pipeline momentum: Positive outcomes across four clinical programs (subcu VK2735, oral VK2735, VK2809 VOYAGE histology, VK0214 Phase 1b) in 2024, underscoring breadth and execution .
  • Strong liquidity: Quarter‑end cash and investments of $0.93B enable Phase 3 initiation (subcu VK2735), Phase 2 oral VK2735, and continued development of VK2809/VK0214 without near‑term financing risk .
  • Regulatory progress: Scheduled End‑of‑Phase 2 meeting for subcu VK2735 in 4Q24; FDA written responses received for VK2809 Phase 3 path; oral VK2735 Phase 2 design readiness .

Management quote: “With $930 million in cash and equivalents, we believe we have the financial resources to achieve multiple important milestones with our clinical programs.” — Brian Lian, CEO .

What Went Wrong

  • Continued losses: Net loss widened YoY to $24.9M in Q3 2024 on increased R&D and G&A, reflecting higher manufacturing, compensation, and regulatory costs .
  • No commercial revenue: Revenues remained $0, so margin metrics are not meaningful; the investment case remains entirely clinical/regulatory‑driven .
  • Estimates comparison unavailable: S&P Global consensus data could not be retrieved due to request limits, limiting beat/miss assessment for EPS; however, VKTX is pre‑revenue and typically not guided for EPS/OpEx [GetEstimates error; see Estimates Context].

Financial Results

P&L and EPS Trend

MetricQ3 2023Q1 2024Q2 2024Q3 2024
Revenues ($USD Millions)$0.00 $0.00 $0.00 $0.00
Research & Development ($USD Millions)$18.38 $24.10 $23.77 $22.79
General & Administrative ($USD Millions)$8.89 $9.97 $10.29 $13.77
Total Operating Expenses ($USD Millions)$27.27 $34.07 $34.05 $36.56
Interest Income, net ($USD Millions)$4.73 $6.75 $11.82 $11.53
Net Loss ($USD Millions)$(22.53) $(27.36) $(22.25) $(24.94)
Diluted EPS ($USD)$(0.23) $(0.26) $(0.20) $(0.22)
Weighted Avg Shares (Millions)99.85 103.46 110.39 110.91

Notes:

  • Q/Q: Net loss increased vs Q2 on higher G&A; R&D moderated slightly. Interest income remained strong with cash build supporting non‑dilutive P&L offset .
  • Y/Y: Higher operating spend reflects pipeline scale‑up and manufacturing/regulatory workstreams .

Balance Sheet KPIs

KPIQ1 2024Q2 2024Q3 2024
Cash, Cash Equivalents & ST Investments ($USD Billions)$0.963 $0.942 $0.930
Total Assets ($USD Millions)$967.52 $946.84 $937.89
Total Stockholders’ Equity ($USD Millions)$933.89 $920.98 $911.45

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
VK2735 (Subcu) End‑of‑Phase 2 Meeting4Q24Planned for 2H/4Q24 Scheduled for 4Q24; intend Phase 3 start post‑meeting Maintained/Progressed
VK2735 (Oral) Phase 2 Initiation4Q24Expected to begin 4Q24 Expected to begin 4Q24; Phase 1 escalated to 100 mg Maintained/Detail Added
VK2735 Monthly Dosing (Subcu)FutureNot specified priorPK supports feasibility; likely as stand‑alone study New Detail
VK2735 Auto‑Injector (Phase 3)Phase 3Not specified priorPlan to use auto‑injector in Phase 3; transition if needed New Detail
VK2809 VOYAGE histologyNov 2024Data reported June; AASLD in Nov Late‑breaking oral at AASLD Nov 19 Maintained/Confirmed
VK2809 End‑of‑Phase 2 responses4Q24Meeting planned for 4Q24 FDA written responses received; next steps under review Progressed
VK0214 Phase 1b AMN data2H24Results expected 2H24 Positive results announced; next steps TBD Achieved
Amylin/DACRA IND2025IND planned for 2025 IND planned 2025, internal program advancing Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1)Previous Mentions (Q2)Current Period (Q3)Trend
VK2735 Subcu efficacy/safetyVENTURE: up to 14.7% baseline weight loss; well‑tolerated Advancing to Phase 3; End‑of‑Phase 2 planned EOP2 scheduled; Phase 3 intent; monthly maintenance feasible; placebo‑controlled in first 2 Phase 3 studies Advancing
VK2735 Oral programUp to 5.3% baseline weight loss at 28 days; safe/tolerable Dose escalation ongoing; Phase 2 planned 4Q24 Dose escalated to 100 mg; Phase 2 in 4Q; ObesityWeek poster Nov 3 Advancing
Manufacturing/supply chain (peptides)Strengthened balance sheet from offering Capacity plans implied by advancing programs Dialogues with global peptide suppliers; synthetic route discussions; blockbuster‑scale confidence Scaling up
VK2809 NASH/MASHVOYAGE primary endpoint achieved; MRI‑PDFF 38–55% 52‑week histology: NASH resolution 63–75%; fibrosis improvement 44–57% AASLD oral; EOP2 responses received; partnering preferred for Phase 3 Toward reg path/partnering
VK0214 X‑ALDPhase 1b enrolling; results mid‑year Enrollment complete; results 2H24 Positive Phase 1b biomarker/safety; next step likely registrational focused on functional/QoL endpoints Positive data; planning
Amylin/DACRANot highlightedPreclinical data at ADA; IND 2025 Dual amylin/calcitonin balance viewed as optimal; high value in combo with GLP‑1/GIP; combination strategy planned Building toward clinic

Management Commentary

  • “The first 3 quarters of 2024 have been data‑rich for Viking, with the company delivering positive data from 4 clinical programs and promising in vivo data from a new preclinical program.” — Brian Lian .
  • “Based on written feedback from the agency, we intend to advance VK2735 into Phase III development for obesity… End‑of‑Phase II meeting… later this quarter.” — Brian Lian .
  • “We think that monthly dosing is very feasible… we would probably target a stand‑alone [study].” — Brian Lian .
  • “We will be using an auto‑injector in [the Phase 3] study… utilize that from the onset if available; otherwise transition.” — Brian Lian .
  • “With $930 million in cash and equivalents… the financial resources required to reach clinical milestones for each of our programs.” — Brian Lian .

Q&A Highlights

  • Subcu VK2735 Phase 3 design: Placebo‑controlled in first two studies; active comparator may come later; monthly dosing feasible with supportive PK; auto‑injector planned .
  • Oral VK2735: Dose escalated to 100 mg; tolerability strong; Phase 2 to start in 4Q; ObesityWeek poster to disclose added details .
  • Manufacturing: Ongoing dialogues with global peptide suppliers; synthetic route evaluation in progress; confidence in blockbuster‑scale supply .
  • VK2809 strategy: Evaluating FDA EOP2 responses; AASLD oral late‑breaker; partnering with large pharma still preferred for registrational path .
  • Amylin/DACRA: Dual amylin/calcitonin agonism targeted; balanced receptor activity may yield better weight loss; significant add‑on value with GLP‑1/GIP; combos envisioned post single‑agent entry .

Estimates Context

  • S&P Global consensus estimates for Q3 2024 EPS and revenue were unavailable due to exceeded daily request limits from the data provider at the time of query; consequently, beat/miss versus consensus cannot be assessed in this recap. VKTX is pre‑revenue, and the company does not provide financial guidance for EPS or revenue; investor focus is on clinical/regulatory milestones and cash runway .

Key Takeaways for Investors

  • Funding runway de‑risks execution: $0.93B cash/investments supports Phase 3 (subcu VK2735), Phase 2 (oral VK2735), VK2809 next steps, and VK0214 program maturation without near‑term capital needs .
  • Near‑term catalysts: ObesityWeek posters (Nov 3) for VK2735 (subcu PK, oral Phase 1 data); AASLD late‑breaker (Nov 19) for VK2809 histology; FDA EOP2 outcomes for subcu VK2735 and VK2809 path—each could move the stock .
  • Subcu VK2735 positioning: Phase 3 design clarity (placebo‑controlled, auto‑injector) and monthly maintenance feasibility strengthen commercial narrative on convenience and adherence .
  • Oral VK2735 optionality: 13‑week Phase 2 initiation in 4Q expands franchise reach; management views oral as ~20% of opportunity with subcu ~80%, reinforcing injectable anchor strategy .
  • VK2809 differentiation: Best‑in‑class histology endpoints with lipid benefits provide a partnering‑ready asset; watch for regulatory feedback and BD updates post‑AASLD .
  • Execution scaling: Hiring across regulatory, clinical, manufacturing/formulation, market access, and biostatistics indicates readiness for larger trials—reduces operational risk heading into Phase 3 .
  • Risk factors: No commercial revenue; trial timelines and regulatory outcomes are key; manufacturing scale‑up and auto‑injector readiness are execution dependencies, though management expresses confidence .