Trevi Therapeutics (TRVI) investor relations material

Strategic vision and future plans

• Aims to establish a leadership position in chronic cough with Haduvio (nalbuphine ER), targeting IPF, non-IPF ILD, and RCC, addressing large, underserved markets with no approved therapies and significant unmet need.

• Advancing three main growth pillars: IPF cough, non-IPF ILD cough, and RCC, with phase III and IIb/III trials initiating in 2024.

• Commercial strategy centers on specialty pricing, a focused sales force (50-75 reps), and rapid adoption as first-line therapy in underserved markets, leveraging concentrated care centers and scalable expansion across indications.

• Patent estate protection prioritized, with foundational patents through 2039 and ongoing efforts to extend exclusivity to the mid-2040s via new filings and label-based claims.

• Financial runway extended into 2030 following a $162 million capital raise and $172M in cash as of March 2026, funding all key clinical programs through pivotal data and NDA submission.

Clinical development and regulatory progress

• OCEAN program (IPF): Two pivotal phase III trials (OCEAN-1, OCEAN-2) launching in 2024, with >95% power for primary efficacy endpoints and topline data expected between 2027 and 2028.

• LAKE program (RCC): Parallel-arm phase IIb trial starting in 2024, designed for dose-ranging and robust efficacy assessment, with interim analyses and regulatory discussions guiding progression.

• Non-IPF ILD: Adaptive phase IIb/III trial to follow IPF program, leveraging similar design and endpoints, with regulatory discussions scheduled for Q3 2024.

• All programs utilize the validated VitaloJAK digital cough monitor for objective measurement, with FDA-required validation studies completed.

• Positive FDA End-of-Phase 2 meetings aligned on clinical and CMC pathways, supporting regulatory advancement toward NDA submission.

Market opportunity and commercial outlook

• Addressable U.S. markets: $5–12B for IPF, $7–15B for non-IPF ILD, and $20B+ for RCC, totaling over $30B, with peak sales potential estimated at $6B+ across all chronic cough indications.

• Physician and payer research indicates strong intent to adopt Haduvio as first- or second-line therapy, with anticipated rapid uptake and specialty-tier pricing ($75,000–$125,000/year).

• Commercial model leverages existing specialty infrastructure, targeting concentrated care centers and pulmonologists, focusing on treatment-resistant RCC for initial launch.

• Payers recognize the unmet need and are expected to provide access at specialty pricing, with minimal contracting and established formulary positions.

• Lessons from recent specialty respiratory launches inform payer engagement, pricing, and patient education strategies.