Tvardi Therapeutics, Inc.

In Q4 2023, KORSUVA injection generated net sales of $5 million. Reported revenue was $3 million for the three months ended December 31, 2023, versus $3.3 million in the same period of 2022. Cost of goods sold was $0.6 million, versus $2.1 million a year ago; R&D expense was $28.4 million, versus $26 million; and G&A was $6.6 million, versus $6.4 million. Cash, cash equivalents, and marketable securities were $100.8 million at December 31, 2023, versus $156.7 million in 2022, and management said current cash is sufficient to fund the operating plan into 2026. For guidance, management expects no meaningful revenue contribution from KORSUVA going forward due to unfavorable reimbursement changes, and expects top-line efficacy and safety results from COURAGE I Part A in Q3.

Chris Posner framed 2023 as a year of strategic sharpening, saying Cara is now focused on the program with the highest likelihood of clinical and commercial success: oral difelikefalin for notalgia paresthetica. He emphasized the large unmet need, the absence of approved therapies, and the strong interest generated by the February 2023 NEJM publication and rapid site enrollment. His tone was confident and optimistic, but disciplined: he said the company’s intent is to keep advancing NP internally rather than partner it at this stage.

Ryan Maynard focused on the balance sheet impact of the HealthCare Royalty transaction, saying Cara brought forward ex-U.S. and Japan royalties in a nondilutive way. He said the company recorded the HCR proceeds as a long-term liability, with royalties from CSL and Maruishi shown as non-cash other revenue and non-cash imputed interest also recorded. He cited $100.8 million in cash, cash equivalents, and marketable securities at year-end, explained the decline from $156.7 million by $92.1 million of operating cash use partly offset by $36.5 million of HCR proceeds, and said the company’s cash now funds operations into 2026.

Analysts asked how large the Phase 3 program might be, how many doses should move forward, and whether the asset could be partnered. Management said Part B size will depend on Part A results and KOMFORT data, but ideally only one dose would advance to simplify the pivotal program. On partnering, management said the asset is unencumbered but the current intent is to continue development internally. Questions also focused on placebo expectations, quality-of-life endpoints, and safety; management said placebo may run slightly higher because of the 3:1 randomization, more sites, and greater awareness, and that Q3 readout will include top-line efficacy and safety with typical adverse event and discontinuation detail.