Tvardi Therapeutics (TVRD) Q3 2024 earnings summary

Executive summary

• Discontinued oral difelikefalin program in notalgia paresthetica (NP) after lack of efficacy in KOURAGE-1 study; not due to safety or regulatory issues.

• Board approved a streamlined operating plan and a 70% workforce reduction, completed by June 2024, to explore strategic alternatives for maximizing shareholder value.

• KORSUVA (difelikefalin) injection remains the only commercial product, out-licensed globally, with limited future revenue expected due to royalty sales and reimbursement changes.

Financial highlights

• Total revenue for Q3 2024 was $2.6M, down 47% year-over-year; nine-month revenue was $5.7M, down 68%.

• Net loss for Q3 2024 was $12.5M, improved from $28.0M in Q3 2023; nine-month net loss was $63.2M, improved from $86.2M year-over-year.

• Collaborative revenue for Q3 2024 was $1.3M, down 47% year-over-year; nine-month collaborative revenue was $2.1M, down 80%.

• No commercial supply or royalty revenue in Q3 2024 due to HCR royalty sale and lower KORSUVA sales; other non-cash revenue of $1.3M in Q3 2024 reflects royalties sold to HCR.

• Cash, cash equivalents, and marketable securities totaled $42.0M as of September 30, 2024.

Outlook and guidance

• No meaningful revenue contribution expected from KORSUVA injection or ex-U.S. royalties/milestones due to CMS reimbursement changes and royalty sale to HCR.

• Current cash and equivalents expected to fund operations for at least the next 12 months, with focus on strategic alternatives.

• Future R&D and operating expenses expected to decrease significantly following program discontinuations and workforce reductions.