Trevi Therapeutics, Inc. (TRVI)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 delivered a narrower net loss and an EPS beat versus Wall Street: diluted EPS was $(0.09) vs consensus of $(0.122), driven by lower R&D and higher interest income; revenue remained $0 as the company is pre-commercial. Bold beat: EPS beat by $0.032 per share.*
• Operational execution remained strong: CORAL (IPF chronic cough) enrollment completed with last patient last visit in April, data lock preparation underway; discontinuation rates stayed below 10%.
• RCC Phase 2a RIVER results were robust (57% placebo-adjusted reduction in cough; p<0.0001), reinforcing Haduvio’s central + peripheral mechanism across chronic cough indications.
• Guidance improved: cash runway extended to the fourth quarter of 2026 (vs second half 2026 previously), and CORAL topline timing narrowed to Q2 2025, creating a near‑term catalyst path.

What Went Well and What Went Wrong

What Went Well

• Strong RCC efficacy: “Haduvio met the primary endpoint… 57% on a placebo-adjusted basis (p<0.0001)” and showed benefit across moderate and severe cough counts, a differentiator vs peripherally acting agents.
• CORAL momentum and trial discipline: Enrollment completion and LPLV in April; management reiterated <10% discontinuations and no unusual safety signals.
• Clear FDA engagement: Company received timely Type C written responses on endpoint validation; management emphasized constructive guidance and plans for end-of-Phase II meetings.

What Went Wrong

• No product revenue yet; continued operating losses: Net loss was $(10.3)M, reflecting clinical-stage status and ongoing OpEx.
• G&A rose YoY to support scaling: Q1 G&A increased to $3.7M from $3.1M YoY, reflecting higher personnel costs, which modestly offsets R&D savings.
• Complexity and multi-country operations add execution risk: Management highlighted the burden of running a tough parallel-arm IPF cough trial across 60 sites in 10 countries, underscoring trial operational risk until data are disclosed.

Financial Results

P&L Comparison (YoY, QoQ)

Interpretation: Net loss narrowed QoQ and YoY primarily on lower R&D and higher interest income; G&A increased YoY with added personnel, reflecting growth and readiness for late-stage development.

Balance Sheet Trend

Revenue, EPS vs Estimates (Wall Street)

Values retrieved from S&P Global.*

Why the beat: Lower R&D spend YoY and higher interest income lifted EPS relative to expectations; no revenue change given clinical-stage profile.

Margins

KPIs (Clinical/Operational)

Segment breakdown: Not applicable (no commercial segments).

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Trevi is at a pivotal moment with promising data, a dedicated development team advancing trials, and a strong balance sheet to support the continued development of Haduvio.” — Jennifer Good, CEO.
• “In the Phase IIa RIVER study, Haduvio… showed the same strong effect across a broad range of cough counts, including patients with moderate and severe cough frequencies.” — Jennifer Good, CEO.
• “As of March 31, 2025, our cash and investments totaled $103.3 million, which gives us runway into the fourth quarter of 2026.” — Lisa Delfini, CFO.

Q&A Highlights

• CORAL success bar: A statistically significant positive trial will move the program forward; safety looks acceptable with discontinuations under 10%.
• Catalysts: Company will outline catalysts path after IPF data; FDA engagements planned for IPF and RCC.
• Respiratory physiology study (TIDAL): On track to complete in 2H 2025; dose coverage aligns with clinical program needs.
• Long-term safety: Plan to include 52 weeks of safety exposure for NDA via extension/Phase III design.
• Commercial stance: Prepared to self-commercialize in US; ex-US partnerships being explored.

Estimates Context

• Q1 2025 EPS: Actual $(0.09) vs consensus $(0.1217) — bold beat by $0.0317 per share.*
• Q1 2025 Revenue: Actual $0.00 vs consensus $0.00 — in line.*
  Values retrieved from S&P Global.*

Where estimates may adjust: If CORAL delivers statistically significant efficacy with acceptable safety and low discontinuations, models may add probability-weighted IPF chronic cough value, raise target prices, and incorporate RCC program acceleration.

Key Takeaways for Investors

• EPS surprise reflects expense discipline and interest income; expect future results to be driven by clinical catalysts rather than P&L line items in the near term.
• Near-term stock catalyst: CORAL topline in Q2 2025; management sees a statistically significant result as sufficient to advance to pivotal development.
• RCC strength broadens optionality: Strong efficacy across moderate and severe coughers differentiates Haduvio vs peripherally acting agents and supports a treatment-failure positioning.
• Regulatory risk mitigants: FDA Type C guidance on endpoint validation and clear long-term safety expectations add visibility to development path.
• Balance sheet supports execution through key readouts and planning; runway extended to Q4 2026.
• Trading setup: Positive CORAL readout could drive estimate revisions and derisk trajectory; conversely, weak efficacy or unexpected safety could compress probability of success across indications.
• Medium-term thesis: First-in-class IPF chronic cough and potential best-in-class across chronic cough indications via central + peripheral mechanism, with a specialty commercial strategy and ex-US partnership leverage.