Tvardi Therapeutics, Inc. Q4 FY2022 earnings call

1. KORSUVA Launch: In Q4 2022, net sales were $2.3M, profit $1.1M, and 21,000 vials shipped. Transitioning from stocking/trial to adoption/demand phase. Positive feedback from providers/patients. Different dynamics in Fresenius, DaVita, and MDO/IDO segments with reorders increasing. 2. Pipeline Progress: Oral difelikefalin Phase 3 programs in CKD and AD progressing; Phase 2/3 program in NP initiated. Positive Phase 2 results in NP. KORSUVA rollout in Europe and international markets, with Japan expected to decide in H2 2023. 3. Financials: Q4 2022 revenue $3.3M, COGS $2.1M, R&D $26M, G&A $6.4M. Cash at year-end $156.7M.

For the fourth quarter of 2022, net sales for KORSUVA injection were $2.3 million, translating into $1.1 million of profit recorded as revenue to Cara, and wholesaler shipments to dialysis clinics totaled approximately 21,000 vials. Total revenue for the three months ended December 31, 2022 was $3.3 million, consisting of $1.1 million collaborative revenue from KORSUVA, $2.1 million commercial supply revenue, and $72,000 royalty revenue. Cash, cash equivalents and marketable securities at December 31, 2022 totaled $156.7 million.

1. Cash runway sufficient to fund operating plan into at least first half of 2024, assuming current spend and KORSUVA revenue. 2. Anticipate top-line data for CKD program in H2 2024, AD program in H1 2025, and NP program internal readout in H2 2024 with final results in H1 2026. 3. Japan regulatory decision expected in H2 2023, potentially bringing milestone payment.

1. Volatility in KORSUVA launch dynamics, especially with inventory management and market adoption. 2. Uncertainty around post-TDAPA reimbursement mechanism from CMS. 3. Dependence on successful clinical trial outcomes for pipeline programs.

Q: Roughly what percentage of 207,000 vials shipped in 2022 have been used?

A: Chris Posner mentioned 180,000 vials shipped to Fresenius in Q3, with trends showing inventory drawdown accelerating into Q1 2023.

Q: Potential use of wastage data for TDAPA?

A: Chris Posner stated it's a procedural thing.

Q: Cash runway and R&D spend?

A: Ryan Maynard explained cash runway guidance is conservative, assuming current spend and KORSUVA revenue, sufficient into H1 2024.

Q: Inventory drawdown and demand robustness?

A: Chris Posner noted building market from scratch with positive trends in reorders and confidence in future performance.

Q: TDAPA metric and visibility?

A: Chris Posner explained CMS uses claims data, and Cara has no real-time visibility on that metric.