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Trevi Therapeutics, Inc. (TRVI)·Q4 2024 Earnings Summary

Executive Summary

  • Trevi reported Q4 2024 net loss of $11.4M and basic/diluted EPS of $(0.11); OpEx moderated sequentially as R&D fell to $9.3M after a heavy Q3 .
  • Operational execution was strong: CORAL (IPF chronic cough) SSRE affirmed N=160 in Dec-2024, enrollment completed in Feb-2025, with topline data guided for Q2 2025; RIVER (RCC) delivered highly positive topline on Mar-10, showing 57% placebo-adjusted reduction in 24-hour cough frequency (p<0.0001) .
  • Liquidity strengthened via a $50M underwritten offering in Dec-2024, ending 2024 with $107.6M in cash, cash equivalents and marketable securities and runway into H2 2026; management guided cash burn of ~$12–$14M per quarter in Q1–Q2 2025 .
  • Consensus estimates were unavailable from S&P Global at time of analysis; no beat/miss vs. Wall Street consensus can be determined. This will be updated when available.

What Went Well and What Went Wrong

What Went Well

  • RIVER Phase 2a (RCC) met primary endpoint with 57% placebo-adjusted reduction in 24-hour cough frequency and strong efficacy across moderate and severe subgroups; patient-reported outcomes also improved early in dosing .
  • CORAL Phase 2b (IPF chronic cough) SSRE confirmed original sample size (N=160) and conditional power ≥80%, enabling on-time completion of enrollment; discontinuations remained single-digit across the trial .
  • Positive HAP study results supported nalbuphine’s known profile and unscheduled status, de-risking abuse potential ahead of NDA planning; management emphasized no new data suggesting scheduling change risk .

What Went Wrong

  • Net loss widened year-over-year (Q4 2024 vs. Q4 2023) as R&D scaled with multiple programs (CORAL, RIVER, HAP, TIDAL); other income declined on lower balances and yields .
  • Lack of revenue and ongoing clinical investment continue to drive cash burn; management projects $12–$14M quarterly burn in early 2025 before details of next trials are finalized .
  • Consensus estimates from S&P Global were not retrievable due to rate limits, limiting the ability to frame the quarter vs Street; this constrains beat/miss analysis pending data availability.

Financial Results

Quarterly P&L (sequential comparison)

Metric ($USD Millions unless noted)Q2 2024Q3 2024Q4 2024
Research & Development$10.02 $11.22 $9.33
General & Administrative$3.27 $2.86 $2.92
Total Operating Expenses$13.29 $14.09 $12.24
Other Income, net$0.93 $0.81 $0.84
Net Loss$12.35 $13.24 $11.42
Basic & Diluted EPS ($)$(0.12) $(0.13) $(0.11)
Weighted Avg Shares (Millions)101.04 99.33 106.01

YoY (Q4 2024 vs Q4 2023)

Metric ($USD Millions unless noted)Q4 2023Q4 2024
Research & Development$6.52 $9.33
General & Administrative$2.42 $2.92
Total Operating Expenses$8.93 $12.24
Other Income, net$1.13 $0.84
Net Loss$7.82 $11.42
Basic & Diluted EPS ($)$(0.08) $(0.11)
Weighted Avg Shares (Millions)99.49 106.01

Liquidity KPIs

Metric ($USD Millions)Q2 2024 (6/30)Q3 2024 (9/30)Q4 2024 (12/31)
Cash & Cash Equivalents$12.96 $16.05 $34.10
Marketable Securities$56.53 $49.44 $73.53
Working Capital$65.38 $58.21 $98.92
Total Assets$73.81 $68.91 $110.90
Stockholders’ Equity$66.17 $58.97 $99.64

Note: Trevi is clinical-stage and reports no product revenue; segment breakdown not applicable .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CORAL topline timing (IPF chronic cough)2025“First half of 2025” (post-SSRE, if no upsize) “Second quarter of 2025” Narrowed/maintained timeline
CORAL SSRE outcomeDec 2024Expected in Dec 2024 Positive SSRE; original N=160 confirmed Achieved; affirmed powering
CORAL enrollmentFeb 202550% enrolled as of Oct 2024 Enrollment completed Feb 2025 Completed
RIVER topline timing/outcome (RCC)Q1 2025Topline expected Q1 2025 Positive topline announced Mar 10, 2025 (57% placebo-adjusted, p<0.0001) Delivered; strongly positive
Cash runwayThrough H2 2026Into 2026 (Q2) ; into H2 2026 (Q3) Into H2 2026 Maintained
Cash burn guidanceQ1–Q2 2025Not provided~$12–$14M per quarter (net of interest) New
Capital actionsDec 2024Not providedCompleted $50M underwritten offering New
Fully diluted sharesCurrentNot provided~137M fully diluted incl. ~10M options New

Earnings Call Themes & Trends

TopicQ2 2024 (Prior-2)Q3 2024 (Prior-1)Q4 2024 (Current)Trend
R&D execution (RIVER, CORAL)RIVER ~80% enrolled; CORAL SSRE planned Q4 RIVER completed enrollment; CORAL 50% enrolled CORAL SSRE positive; enrollment completed; RIVER topline highly positive Accelerating progress
Abuse potential (HAP)~95% enrolled; topline expected Q4 Dosing completed; topline expected Dec Positive HAP supporting unscheduled status De-risking
Regulatory strategyNot detailedNot detailedPlan End-of-Phase II FDA meeting by end-2025 (IPF first NDA; RCC as sNDA) Clarity increased
Cash runway/capitalRunway into 2026 Runway into H2 2026 Runway into H2 2026; $50M raise completed Stable; strengthened liquidity
Placebo/endpoint assumptionsNot discussedNot discussedPlacebo assumed 30%; drug effect 66%; discontinuations single-digit; EXACT2 and CSS secondary endpoints Trial design rigor
RCC positioningNot detailedNot detailedTarget treatment-failure RCC; no stratification (moderate vs severe) going forward; likely lower effective dose range (27–54 mg) Commercial/clinical focus refined

Management Commentary

  • “Haduvio is now the first and only therapy in clinical development to show a statistically significant reduction in chronic cough across patients with IPF and RCC.”
  • “The SSRE confirmed the original sample size of 160 patients… conditional power at the 50% enrollment point of at least 80% or greater.”
  • “Our cash runway guidance into the second half of 2026 remains unchanged… cash burn net of interest income of about $12–$14 million per quarter in Q1 and Q2.”
  • “We expect to prepare for an end of Phase II meeting with the FDA… IPF first NDA; RCC as sNDA.”

Q&A Highlights

  • Enrollment quality and continuity: No protocol or site changes post-SSRE; discontinuations remained single-digit across CORAL, supporting data integrity .
  • Placebo assumptions: Assumed 30% placebo and 66% drug effect for powering; historical IPF placebo generally 15–23%; no placebo run-in—two-week titration used .
  • Dose range and AEs: RIVER suggests effective dosing in 27–54 mg range, potentially avoiding 108 mg for RCC; slower titration and nighttime dosing considered to manage tolerability .
  • RCC strategy: Focus on treatment-failure population with documented prior antitussive failures; no stratification between moderate/severe going forward .
  • Secondary endpoints/payer relevance: Emphasis on cough severity and quality-of-life metrics alongside objective cough frequency to support payer acceptance .

Estimates Context

  • S&P Global consensus estimates for EPS and revenue were unavailable at time of retrieval due to rate limits; as a result, beat/miss vs. Street cannot be assessed for Q4 2024. This section will be updated when access is restored.
  • Trevi is pre-commercial with no product revenue; net loss and OpEx are key financial focus areas until commercialization .

Key Takeaways for Investors

  • Near-term catalyst: CORAL Phase 2b topline in Q2 2025; SSRE positivity and single-digit discontinuations are constructive for risk-adjusted expectations .
  • Differentiated profile: First to show significant cough reduction across IPF and RCC; central/peripheral KAMA mechanism positions Haduvio for broad chronic cough indications .
  • RCC development strategy: Targeting treatment-failure segment with likely lower effective dose range (27–54 mg) and simplified inclusion criteria (no moderate/severe stratification) .
  • Regulatory path: IPF targeted for initial NDA with RCC as sNDA; End-of-Phase II meeting planned by end-2025—watch for safety database sizing and open-label extension plans .
  • Liquidity: $107.6M cash/securities and runway into H2 2026; $50M Dec-2024 raise reduces financing risk ahead of pivotal program planning .
  • Financial trajectory: Sequential OpEx moderation in Q4 after a heavy Q3; management guiding $12–$14M quarterly cash burn in early 2025 pending trial designs .
  • Data visibility: Expect further RCC and IPF cough data disclosure at ATS (May) and ERS (Sept), aiding dose optimization and endpoint strategy .