Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 416

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 416
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 third quarter of 2022, large dialysis organizations (LDOs), came on-line driving a significant quarter-to-quarter increase in order volume from the wholesaler. This stocking at the clinic level, particularly from Fresenius Medical Care (FMC), resulted in significant subsequent quarterly revenue fluctuations. In the third quarter of 2023, FMC decided to reallocate all remaining clinic level inventory within its network of clinics resulting in limited revenues in the fourth quarter of 2023 and the nine months ended September 30, 2024. KORSUVA Injection and Kapruvia Revenue and Other Metrics Cara generates revenue from its commercial products KORSUVA injection and Kapruvia primarily through its collaboration agreements with CSL Vifor:

| ● | Collaborative revenue from Cara’s share of the profit generated by KORSUVA injection sales in the United States. For the three months ended September 30, 2024 and 2023, Cara recorded collaborative revenue of $1.3 million and $1.9 million, respectively. For the nine months ended September 30, 2024 and 2023, Cara recorded collaborative revenue of $2.1 million and $10.1 million, respectively. |

| ● | Commercial supply revenue from Cara’s sales of commercial product to CSL Vifor, which is subsequently sold to wholesalers. There was no commercial supply revenue recorded during the three months ended September 30, 2024. For the three months ended September 30, 2023, Cara recorded commercial supply revenue of $1.3 million. For the nine months |

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| ended September 30, 2024 and 2023, Cara recorded commercial supply revenue of $0.6 million and $5.8 million, respectively. |

| ● | Royalty revenue in conjunction with the launch of Kapruvia. For the three and nine months ended September 30, 2023, Cara recorded royalty revenue of approximately $167,000 and $415,000, respectively, which represented royalty payments earned by Cara. Cara recorded no royalty revenue in connection with Kapruvia for the three and nine months ended September 30, 2024 as a result of entering the Original HCR Agreement in the fourth quarter of 2023. |

During the fourth quarter of 2023, Cara entered into the Original HCR Agreement where Cara sold its current and future royalties and milestone payments for Kapruvia and KORSUVA injection to HCR. For the three and nine months