Tvardi Therapeutics (TVRD) Q2 2024 earnings summary

Executive summary

• Discontinued the clinical program in notalgia paresthetica (NP) after oral difelikefalin failed to show clinical benefit, leading to a 70% workforce reduction and a strategic review to maximize shareholder value; no safety or regulatory issues cited.

• KORSUVA injection (IV difelikefalin) remains approved and commercialized in the US, EU, Japan, and other countries, but US revenues have declined due to reimbursement changes and future revenue contribution is expected to be minimal.

• Entered into an HCR Agreement in late 2023, selling future ex-US royalties and milestones for KORSUVA/Kapruvia and Japan to HCR for up to $40M, reducing future royalty revenue.

• Exploring strategic alternatives to maximize shareholder value, including potential transactions or dissolution, with sufficient cash to fund operations for at least 12 months.

Financial highlights

• Total revenue for Q2 2024 was $1.0M, down 86% from $6.9M in Q2 2023; six-month revenue was $3.1M, down 76% year-over-year.

• Net loss for Q2 2024 was $20.0M (vs. $31.5M in Q2 2023); six-month net loss was $50.7M (vs. $58.1M prior year).

• No collaborative or commercial supply revenue in Q2 2024 due to negative net sales of KORSUVA injection in the US; negative profit share of $1.4M recorded as a liability.

• Other revenue of $1.0M in Q2 2024 reflects non-cash royalties remitted to HCR under the HCR Agreement.

• Cash, cash equivalents, and marketable securities totaled $56.6M as of June 30, 2024.

Outlook and guidance

• No meaningful revenue expected from KORSUVA injection or Kapruvia royalties/milestones in the foreseeable future due to the HCR agreement and unfavorable US reimbursement changes.

• Current cash and equivalents expected to fund operations for at least the next 12 months, focused on winding down activities and exploring strategic alternatives.

• Additional capital would be required to resume development of any product candidates.