Tvardi Therapeutics, Inc. Q2 FY2022 earnings call

KORSUVA Injection Launch

• Progress with partner Vifor Pharma; independent and midsized dialysis organizations adopted quickly due to shorter contract negotiations, simpler EMR implementation, and faster treatment protocol establishment. Large dialysis organizations (75% of the market) are starting to order in the third quarter, with Fresenius Renal Pharma's sales force promoting KORSUVA to Fresenius Dialysis Clinics.

Kapruvia Milestone

• Received $15 million milestone payment from EU approval in April.

Oral Difelikefalin Pipeline

• Positive Phase 2 proof-of-concept data in notalgia paresthetica (NP) showed broad potential. Plan to share detailed data at a medical meeting and meet with FDA in H2 2022 to discuss next steps for NP. Phase 2 proof-of-concept in primary Biliary Cholangitis (PBC) expected in H2 2022. Phase 3 programs in atopic dermatitis (AD) and non-dialysis dependent chronic kidney disease (CKD) on track with previous timelines.

Total revenues for the second quarter were $23 million. This consisted of $8 million in profit sharing revenue from KORSUVA injection and $15 million in a milestone payment from the EU approval of Kapruvia in April.

Cara expects current unrestricted cash and equivalents, along with marketable securities, to fund operating expenses and capital requirements into the first half of 2024 without relying on product revenue from KORSUVA, Kapruvia, or milestone payments.

Forward-looking statements subject to risks and uncertainties, including commercialization risks of KORSUVA and Kapruvia, regulatory timelines, performance of commercial partners, clinical trial outcomes, and impact of macroeconomic conditions like COVID-19, geopolitical tensions.

Q: Can you help us understand the wholesaler number of 1,812 vials and how that translates to 16 million in net KORSUVA sales?

A: Revenue is recognized when Vifor ships product to the wholesaler. The 1,812 vials are what clinics order from the wholesaler, so it's a timing difference in revenue recognition.

Q: Can you give more color on expectations for organic demand from larger institutions and comment on Fresenius vs DaVita?

A: Vifor shipped product into the channel anticipating future demand. Fresenius Salesforce is additive, and LDOs are starting to order. Details on specific customers not provided, but LDOs are the majority market.

Q: What types of features would you seek to gain alignment with on the FDA regarding Phase 3 design for NP?

A: Joe Goncalves will discuss NP; focus on clinical development program details and future discussions with FDA regarding Phase 3 design.

Q: Comment on initial margins from Vifor and cadence of Kapruvia launch?

A: Profit share of $8 million on net sales of ~$17 million was in line with expectations. Kapruvia launched in April 2022, with Vifor planning to launch in several countries in H2 2022, dependent on reimbursement negotiations.

Q: Thoughts on quarterly sales and profit sharing cadence, especially for 3Q and 4Q?

A: Demand expected to accelerate as LDOs come online. Channel strategy and inventory drawdown expected in Q3, with Q4 dependent on demand transpiration.

Q: Commentary on margins and future profitability of KORSUVA, and timing of large dialysis centers coming on board?

A: Profit share was in line with expectations. Large dialysis centers took longer due to complexity in protocols, contracts, staff training, and system updates, but they are now starting to order.