Company: TVRD
Filing Date: 2025-02-14
Form Type: S-4/A
Source: 0001104659-25-013053
Chunk: 591

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: S-4/A
Chunk 591
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 million (before South Korean withholding tax) of development and regulatory milestones have been received under the CKDP Agreement. In December 2021, CMS granted TDAPA designation to KORSUVA injection in the anti-pruritic functional category. TDAPA went into effect on April 1, 2022, for two years. On October 27, 2023, CMS published the final CY 2024 rule, which finalized the post-TDAPA add-on as proposed in the draft CY 2024 rule. Under the final rule, TDAPA drugs in existing functional categories will receive a post-TDAPA add-on payment set at 65 percent of the total trailing 12-months expenditure levels for the given renal dialysis drug or biological product. The post-TDAPA add-on payment adjustment will be applied to all ESRD PPS payments and paid for 3 years, adjusted annually. The add-on payments for KORSUVA injection commenced on April 1, 2024. The unfavorable CMS reimbursement codified in the final CY2024 rule has resulted in a lack of sequential revenues growth for KORSUVA injection since its launch. As a result, Cara expects no meaningful revenue contribution from KORSUVA injection post its TDAPA expiration. Cara’s ability to earn these milestone and royalty payments and their timing is dependent upon successful commercialization of KORSUVA injection/Kapruvia, and successful future repayments made to HCR using CSL Vifor and Maruishi milestones and royalties under the Original HCR Agreement. However, Cara’s receipt of any further such amounts is uncertain at this time and Cara may never receive any more of these amounts. Outlook As a result of the discontinuation of Cara’s clinical NP program, Cara’s workforce reductions in 2024, and Cara’s exploration of strategic alternatives to maximize shareholder value, Cara expects that its current unrestricted cash and cash equivalents and available-for-sale marketable securities will be sufficient to fund its currently anticipated operating plan for at least the next 12 months. Cara’s anticipated operating expenses include contractually committed costs as well as non-contractually committed clinical trial costs for trials that are closing based on the Cara Board’s new strategic plan. It is possible that the assumptions upon which Cara has based this estimate may prove to be wrong, and Cara could use its capital resources sooner than it presently expects. Cash Flows For the Nine Months Ended September 30, 2024 and 2023 The following is a summary of the net cash flows provided by