Tvardi Therapeutics, Inc. Q1 FY2022 earnings call

• Chris Posner highlighted the pivotal first quarter as Cara moves to a commercial stage, with KORSUVA injection US launch proceeding as planned. Key objectives in the first four weeks of launch were met, including products being available for ordering, nephrologists aware and prescribing, and patient outreach expanding. - Kapruvia approved in EU/UK, triggering a $15 million cash milestone, with EU rollout expected in second half of 2022. - Strategic priorities include maximizing KORSUVA commercial potential, advancing oral KORSUVA Phase 3 programs, and expanding clinical utility of oral KORSUVA. Phase 2 proof-of-concept data for notalgia paresthetica expected in Q2, and Phase 2 data for PBC pruritus in second half of 2022. - Tom Reilly provided financial details, noting cash, cash equivalents, and marketable securities at March 31, 2022, totaled $209.6 million, with existing cash expected to fund operations into first half of 2024.

Total revenue for the first quarter of 2022 was $4.8 million, compared to $1.9 million in the same period of 2021. The $12.8 million in Q1 2022 related to KORSUVA injection commercial supply to Vifor Pharma. R&D expenses were $21.3 million for Q1 2022 compared to $19.1 million in Q1 2021, due to increases in direct clinical trial and payroll-related costs. G&A expenses were $9.3 million for Q1 2022 compared to $6.4 million in Q1 2021, principally due to stock-based compensation and payroll-related cost increases.

• Cara expects existing unrestricted cash and cash equivalents, including the $15 million EU milestone, to fund operating expenses and capital requirements into first half of 2024. - Q2 expected to provide more quantitative metrics on KORSUVA net sales, Cara’s revenue from KORSUVA, and aggregate wholesaler sales volume as a proxy for end user demand.

• Forward-looking statements subject to risks and uncertainties, including successful commercialization of KORSUVA, regulatory submissions/approvals, coverage/reimbursement, commercial partner performance, clinical trial outcomes, and impact of COVID-19. Risks detailed in SEC filings.

Q: On IV KORSUVA, could you provide additional color on the addressable patient population and initial patients?

A: Chris Posner stated the addressable market is ~40% of dialysis patients with moderate to severe pruritus, roughly 200,000 U.S. hemodialysis patients. Nephrologists are actively identifying these patients now that a solution is available.

Q: On second quarter expectations, could you clarify components of revenue?

A: Tom Reilly explained the $15 million EU milestone will be separated, profit split revenue from KORSUVA will be disclosed, and commercial supply revenue will be broken out separately, with transparency on P&L items.

Q: On notalgia paresthetica proof-of-concept data, will it be reported similarly and assumptions?

A: Dr. Joana Goncalves said top line data will be shared in Q2, with no prior robust placebo-controlled study benchmarks, and they expect a numerical separation from placebo.

Q: On R&D expenses, will they increase?

A: Tom Reilly stated they don't guide quarter-by-quarter but existing cash runway carries operations into first half of 2024 without considering KORSUVA revenue.

Q: On launch pushback or nitpicks for KORSUVA IV?

A: Chris Posner said no pushback, with general excitement in the nephrology community as there are few treatment alternatives in CKD dialysis.

Q: On EU commercial dynamics and model?

A: Chris Posner mentioned Europe has ~300,000 dialysis patients with ~40% addressable, launch to occur sequentially in Germany first in second half of 2022, with Vifor working on pricing, and Tom Reilly noted royalty-based agreement outside US with tiered double-digit royalty structure.