Tvardi Therapeutics, Inc. Q1 FY2023 earnings call

• KORSUVA injection launch: Net sales $5.7M in Q1 2023. Wholesaler shipments to dialysis clinics doubled q-o-q to 46,000 vials. 64% of vials to Fresenius/FMC clinics, 36% split between DaVita and others. FMC clinics saw orders triple q-o-q, 500 clinics (18%) placed reorders, 1,500 clinics (56%) dosed at least one patient. DaVita had 300 clinics (11%) order, 70% repeat orders. Midsize/independent DOs had 13% order, 66% repeat orders.
• International rollout: Kapruvia in Europe had $1.2M net sales, royalty revenue $125k. Rollout began in 4 additional countries, total 7 launch countries. A decision from NICE expected imminently, Japan regulatory decision expected H2 2023.
• Oral pipeline: Enrollment in Phase 3 programs for pruritis associated with advanced chronic kidney disease and atopic dermatitis progressing. Internal readout of Part A of KIND 1 AD trial expected Q4 2023, final top line results H1 2025. Top line results for KICK program H2 2024. Phase 2/3 program in notalgia paresthetica started Q1 2023, internal readout of KOURAGE 1 Part A H2 2024, final topline results H1 2026.

For the first quarter of 2023, KORSUVA injection had net sales of $5.7 million, translating to $2.8 million in profit. Kapruvia generated $1.2 million in net sales, resulting in $125,000 of royalty revenues. Total revenue was $6.2 million, consisting of $2.8 million collaborative revenue from KORSUVA, $3.2 million commercial supply revenue, and $125,000 royalty revenue. Cost of goods sold was $2.6 million. Research and development expenses were $24.3 million, general and administrative expenses were $6.9 million. Cash, cash equivalents, and marketable securities totaled $123.4 million as of March 31, 2023.

Ryan Maynard stated that current unrestricted cash and cash equivalents, and available-for-sale marketable securities are sufficient to fund operating plan into H2 2024, assuming spend related to late stage clinical programs and KORSUVA revenue profit share contribution. Also, exploring certain non-diluted financing opportunities to extend runway further.

Q: Do you expect your partner to hit steady state operating margins on this product before TDAPA and how important would that be for that to happen so you could start realizing substantial collaboration revenue?

A: Ryan Maynard said the profit split is roughly 46% of every dollar, and it's pretty steady, not material to fluctuate significantly.