Executive Summary

Pre-revenue biotech quarter; operating loss widened as Phase 3 readiness and program breadth drove higher R&D and G&A. Q4 net loss was $35.4M ($0.32/share) vs. $24.9M ($0.22) in Q3 and $22.3M ($0.20) in Q2; year-end cash and investments stood at $903M, supporting planned obesity Phase 3 trials in 2Q25 .
Subcutaneous VK2735 (GLP-1/GIP) advancing to Phase 3 in obesity in 2Q25 after completing End-of-Phase 2; management highlighted potential monthly maintenance dosing based on PK/weight maintenance observed post-dosing .
Oral VK2735 28‑day data at ObesityWeek showed up to 8.2% mean weight loss (placebo‑adjusted up to 6.8%) with a mild GI profile; a 13‑week Phase 2a (VENTURE‑Oral) is underway with data expected 2H25 .
VK2809 (NASH/MASH) final VOYAGE readout underscored best‑in‑class histology (NASH resolution 63–75%; fibrosis improvement 44–57%) with favorable lipids; company evaluating next steps after End‑of‑Phase 2 .
Stock catalysts: formal Phase 3 start (2Q25), monthly‑dosing maintenance study details, 2H25 oral VK2735 data, and partnering updates (VK2809, VK0214) .

What Went Well and What Went Wrong

What Went Well
- Strong obesity franchise momentum: Phase 3 start for SC VK2735 targeted for 2Q25; oral program progressed to 13‑week Phase 2a with favorable 28‑day efficacy/tolerability data .
- Durable efficacy signal supports monthly maintenance: PK subset maintained 94%/83% of weight loss at 4/7 weeks post‑final dose, underpinning planned monthly regimen exploration .
- NASH optionality intact with best‑in‑class histology and lipid effects; End‑of‑Phase 2 completed, next steps under evaluation (incl. partnering) .
- “2024 was an exciting and productive year…four different clinical trials…best‑in‑class data…over $900 million in cash and equivalents,” CEO Brian Lian noted, emphasizing runway and breadth .
What Went Wrong
- Losses widened QoQ and YoY driven by higher OpEx as development scaled (R&D $31.0M in Q4 vs. $22.8M in Q3; G&A $15.3M vs. $13.8M) .
- No quantitative financial guidance; visibility remains tied to clinical milestones and manufacturing scale‑up; management described manufacturing/auto‑injector workstreams as complex and ongoing .
- Estimates context limited; company remains pre‑revenue, and we were unable to retrieve S&P Global consensus this cycle (see Estimates Context) .

Financial Results

Metric ($USD)	Q2 2024	Q3 2024	Q4 2024
Revenues ($MM)	—	—	—
R&D Expense ($MM)	23.77	22.79	30.99
G&A Expense ($MM)	10.29	13.77	15.25
Total Operating Expenses ($MM)	34.05	36.56	46.24
Net Loss ($MM)	(22.25)	(24.94)	(35.42)
Diluted EPS ($)	(0.20)	(0.22)	(0.32)
Cash, Cash Equivalents & Short‑Term Investments ($MM, period‑end)	942	930	903

Notes: Company is pre‑revenue; margin metrics (gross, operating, net margin) are not applicable.

KPIs and Program Readouts

VK2735 SC (VENTURE, 13 weeks): Mean weight loss up to 14.7%; ≥10% weight loss in up to 88% of patients; weight loss remained progressive through 13 weeks .
VK2735 SC (maintenance): 94% of weight loss maintained 4 weeks after last dose; 83% at 7 weeks (PK subset), supporting monthly maintenance exploration .
VK2735 Oral (28 days): Up to 8.2% mean weight loss (placebo‑adjusted up to 6.8%); up to 100% achieving ≥5% weight loss; mild GI profile at up to 100 mg/day .
VK2809 (VOYAGE, 52 weeks): NASH resolution 63–75%; fibrosis improvement 44–57%; both endpoints 40–50%; LDL‑C placebo‑adjusted reduction 20–25% .
VK0214 (X‑ALD, 28 days): ~38% reduction in C26:0‑LPC vs. placebo; favorable lipid changes; well tolerated .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
VK2735 SC (Obesity) – Phase 3 start	2025	Advance to Phase 3; End‑of‑Phase 2 in 4Q24	Phase 3 initiation planned for 2Q25; End‑of‑Phase 2 completed	Window specified; program advanced
VK2735 Oral – 13‑week Phase 2a	2024–2025	Phase 2 expected to begin 4Q24	Phase 2a (VENTURE‑Oral) underway; data expected 2H25	Started; data timing set
VK2809 (NASH) – next steps	2024–2025	Written FDA responses received; planning ongoing	End‑of‑Phase 2 completed; evaluating next steps (partnering)	Regulatory dialogue progressed
VK0214 (X‑ALD) – development path	2024–2025	Positive Phase 1b; assessing data	Positive Phase 1b; exploring partnering	Strategic tilt to partner
DACRA (Amylin/Calcitonin) – IND	2025	IND planned for 2025	IND planned for 2025; tox work ongoing	Maintained

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2, Q3 2024)	Current Period (Q4 2024)	Trend
Phase 3 design/scale for SC VK2735	Planning for Phase 3 per FDA guidance; two studies required; ~$300M program	At least 4,500 subjects across two studies (obesity and T2D); 52‑week window; details at initiation	Greater specificity; timing 2Q25
Monthly maintenance dosing	PK suggested feasibility; planned exploration	Maintenance study planned; aim to prevent weight regain; may seek label inclusion later	Moving from concept toward study design
Oral VK2735 dose/tolerability	Escalation to 100 mg; good tolerability signaled	28‑day data: up to 8.2% weight loss; mild GI to 100 mg; 13‑week Phase 2a underway	Derisking efficacy/tolerability; longer dosing
Manufacturing/API and device	Sufficient clinical supply; engaging CDMOs; auto‑injector considered	Manufacturing agreements progressing; auto‑injector planned with bridging as needed	Execution focus; commercial readiness steps
VK2809 partnering	Preference for larger pharma partner	Evaluating next steps post End‑of‑Phase 2; JPM follow‑up ongoing	Continued BD dialogue
Amylin (DACRA) strategy	Preclinical efficacy; IND 2025; combo potential with GLP‑1/GIP	IND targeted 2025; balanced agonism profile preferred; combo expected to boost efficacy	Pipeline expansion maintained

Management Commentary

“2024 was an exciting and productive year for Viking…positive data from four different clinical trials…best‑in‑class data…over $900 million in cash and equivalents, providing the resources to achieve important clinical goals, including the completion of Phase 3 trials for VK2735 in obesity.” — Brian Lian, CEO .
“We currently expect to initiate Phase III trials evaluating subcutaneous VK2735 for the treatment of obesity in the second quarter of 2025.” .
On maintenance dosing: “…rapidly titrate…to a high dose…then transition…from the weekly to the monthly cadence and really look for…maintenance…at this less frequent dosing interval.” .
On device: “We do plan to introduce an auto‑injector in the Phase III program…would do a bridging study…to make sure…bioequivalence.” .
On financial posture: “We completed 2024 with a strong balance sheet and over $900 million in cash…provides us with the runway to complete Phase III trials for the VK2735‑obesity program.” .

Q&A Highlights

Phase 3 scope: Two trials (obesity and T2D); ≥4,500 subjects across program; 52‑week treatment; doses at initiation announcement .
Monthly/maintenance: Planned study to transition from weekly to monthly dosing; goal to limit weight regain; potential later label inclusion; possible transition to low‑dose oral in same paradigm .
Manufacturing/device readiness: API secured for both Phase 3 studies; comprehensive manufacturing agreements in progress; auto‑injector planned with bioequivalence bridging .
Oral program dose range: Broad range to examine longer‑term efficacy maturation; 120 mg to be explored; tolerability at 100 mg supportive .
BD: VK2809 and VK0214 partnering discussions ongoing; NASH complexity (biopsies) acknowledged .

Estimates Context

Metric	Actual (Q4 2024)	S&P Global Consensus	Surprise
Revenue ($MM)	—	N/A – S&P Global data unavailable this cycle	N/A
Diluted EPS ($)	(0.32)	N/A – S&P Global data unavailable this cycle	N/A

Notes: We attempted to retrieve S&P Global consensus, but the data were unavailable via API at this time. The company is pre‑revenue; EPS comparisons are often the primary estimate focus in this context.

Key Takeaways for Investors

Clear near‑term catalyst path: formal Phase 3 start for SC VK2735 in 2Q25, protocol specifics (doses, titration, endpoints) and auto‑injector plans could re‑rate expectations .
Differentiation via maintenance: Strong post‑dosing weight maintenance supports monthly dosing strategy, potentially improving adherence and payer positioning; watch for study initiation/design .
Oral VK2735 builds breadth: 28‑day efficacy up to 8.2% with mild GI, and a 13‑week Phase 2a underway; 2H25 readout can expand addressable market and combo/transition strategies .
NASH retains optionality: VOYAGE data support best‑in‑class narrative; End‑of‑Phase 2 completed; any partnering move could crystallize value .
Balance sheet strength: $903M cash and investments at year‑end provides runway through Phase 3 execution and pipeline advancement; limits financing overhang near term .
Execution risks persist: Manufacturing/device scale‑up, Phase 3 enrollment pace, GI tolerability at higher exposures, and regulatory endpoints remain the key delivery risks; monitoring updates on manufacturing agreements and trial starts is critical .
Trading lens: Expect sensitivity to Phase 3 start timing/details, maintenance study disclosure, and any BD announcements; pre‑revenue biotech with multiple catalysts can exhibit outsized moves around data and regulatory milestones .

Appendix: Prior Two Quarters (for Trend)

Q3 2024: Net loss $24.9M ($0.22); R&D $22.8M; G&A $13.8M; cash/investments $930M .
Q2 2024: Net loss $22.3M ($0.20); R&D $23.8M; G&A $10.3M; cash/investments $942M .

All figures are from company filings/press materials and earnings call transcripts as cited.

Viking Therapeutics, Inc. (VKTX)·Q4 2024 Earnings Summary