Collaboration and Licensing Agreements	3 Months Ended
Mar. 31, 2025
Collaboration and Licensing Agreements.
Collaboration and Licensing Agreements	11. Collaboration and Licensing Agreements Vifor (International) Ltd. (Vifor International) In October 2020, Cara entered into a license agreement with Vifor International (“Vifor Agreement No. 1”), under which Cara granted Vifor International an exclusive license solely in the United States to use, distribute, offer for sale, promote, sell and otherwise commercialize difelikefalin injection for all therapeutic uses relating to the inhibition, prevention or treatment of itch associated with pruritus in hemodialysis and peritoneal dialysis patients in the United States. Under Vifor Agreement No. 1, Cara retains all rights with respect to the clinical development of, and activities to gain regulatory approvals of, difelikefalin injection in the United States. In conjunction with the consummation of the Asset Disposition, Vifor Agreement No. 1 was terminated (see Note 18, Subsequent Events). After the assignment of rights of Vifor Agreement No. 1 from Vifor International to Vifor Fresenius Medical Care Renal Pharma Ltd. in May 2022, Vifor Agreement No. 1 provided full commercialization rights in dialysis clinics to CSL Vifor in the United States under a profit-sharing arrangement. Pursuant to the profit-sharing arrangement, Cara was generally entitled to 60% of the net profits (as defined in Vifor Agreement No. 1) from sales of difelikefalin injection in the United States and CSL Vifor was entitled to 40% of such net profits (excluding sales to Fresenius Medical Center dialysis clinics, compensation for which was governed by Vifor Agreement No. 2, as defined below), subject to potential temporary adjustment in future years based on certain conditions. Under Vifor Agreement No. 1, in consideration of CSL Vifor’s conduct of the marketing, promotion, selling and distribution of difelikefalin injection in the United States, Cara paid a marketing and distribution fee to CSL Vifor based on the level of annual net sales. This fee as well as CSL Vifor’s cost of goods sold (“COGS”) were deducted from net sales in calculating the net profits that are subject to the profit-sharing arrangement under Vifor Agreement No. 1. In addition, pursuant to Vifor Agreement No. 1, Cara was eligible to receive payments of up to $240,000 upon the achievement of certain sales-based milestones. Cara retained the rights to make and have made difelikefalin injection (the “Licensed Product”) on a non-exclusive basis, in the United States for commercial sale of the Licensed Product for use in all therapeutic areas to prevent, inhibit or treat itch associated with pruritus in hemodialysis and peritoneal-dialysis patients (the “Field”) anywhere in the world and for supply of Licensed Product to CSL Vifor under the terms of a supply agreement (the “Vifor International Supply Agreement”) which was executed in September 2021. The supply price was Cara’s COGS, as calculated under GAAP, plus an agreed upon margin. The Vifor International Supply Agreement would co-terminate with Vifor Agreement No. 1. Cara also retained the rights to import, distribute, promote, sell and otherwise commercialize the Licensed Product on an exclusive basis outside of the Field either in or outside of the United States. The Vifor International Supply Agreement is accounted for as a customer option that is not a material right because the selling price of the Licensed Product under the Vifor International Supply Agreement is Cara’s COGS plus an agreed upon margin, which is commensurate with the “COGS plus” model that Cara would charge other parties under similar agreements (the standalone selling price) and not at a discount. Therefore, the sale of commercial supply to CSL Vifor is not a performance obligation under Vifor Agreement No. 1 but rather the Vifor International Supply Agreement is a separate agreement from Vifor Agreement No. 1. The only performance obligation under the Vifor International Supply Agreement is the delivery of the Licensed Product to CSL Vifor for commercialization. In connection with the consummation of the Asset Disposition, the Vifor International Supply Agreement was terminated (see Note 18, Subsequent Events). Vifor Fresenius Medical Care Renal Pharma Ltd. In May 2018, Cara entered into a license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. (“Vifor Agreement No. 2”) under which Cara granted Vifor Fresenius Medical Care Renal Pharma Ltd. an exclusive, royalty-bearing license, or the Vifor License, to seek regulatory approval to commercialize, import, export, use, distribute, offer for sale, promote, sell and otherwise commercialize the Licensed Product in the Field worldwide (excluding the United States, Japan and South Korea) (the “Territory”). In connection with the consummation of the Asset Disposition, Vifor Agreement No. 2 was terminated (see Note 18, Subsequent Events). Cara was eligible to receive from Vifor Fresenius Medical Care Renal Pharma Ltd. additional commercial milestone payments in the aggregate of up to $440,000, all of which are sales related. Cara was also eligible to receive tiered double-digit royalty payments based on annual net sales, as defined in Vifor Agreement No. 2, of difelikefalin injection in the licensed territories. Cara retained full commercialization rights for difelikefalin injection for the treatment of chronic kidney disease associated pruritus in the United States except in the dialysis clinics of FMCNA, where Vifor Fresenius Medical Care Renal Pharma Ltd. will promote difelikefalin injection under a profit-sharing arrangement (as defined in Vifor Agreement No. 2), based on net FMCNA clinic sales (as defined in Vifor Agreement No. 2) and Cara and Vifor Fresenius Medical Care Renal Pharma Ltd. were each entitled to 50% of such net profits, subject to potential adjustments in a calendar year based on certain conditions. Cara retained the rights to make and have made the Licensed Product in the Territory for commercial sale by Vifor Fresenius Medical Care Renal Pharma Ltd. in the Field in or outside the Territory and for supply of Licensed Product to Vifor Fresenius Medical Care Renal Pharma Ltd. under the terms of a supply agreement (the “Vifor Supply Agreement”) which was executed in May 2020. The supply price was Cara’s COGS, as calculated under GAAP, plus an agreed upon margin. The Vifor Supply Agreement would co-terminate with Vifor Agreement No. 2. The Vifor Supply Agreement is accounted for as a customer option that is not a material right because the selling price of the Licensed Product under the Vifor Supply Agreement is Cara’s COGS plus an agreed upon margin, which is commensurate with the “COGS plus” model that Cara would charge other parties under similar agreements (the standalone selling price) and not at a discount. Therefore, the sale of compound to Vifor Fresenius Medical Care Renal Pharma Ltd. is not a performance obligation under Vifor Agreement No. 2 but rather the Vifor Supply Agreement is a separate agreement from Vifor Agreement No. 2. The only performance obligation under the Vifor Supply Agreement is the delivery of the Licensed Product to Vifor Fresenius Medical Care Renal Pharma Ltd. for commercialization. In connection with the consummation of the Asset Disposition, the Vifor Supply Agreement was terminated (see Note 18, Subsequent Events). Maruishi Pharmaceutical Co., Ltd. (Maruishi) In April 2013, Cara entered into a license agreement with Maruishi (the “Maruishi Agreement”) under which Cara granted Maruishi an exclusive license to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and/or uremic pruritus in Japan. Maruishi has the right to grant sub-licenses in Japan, which entitled Cara to receive sub-license fees, net of prior payments made by Maruishi to Cara. Under the Maruishi Agreement, Cara and Maruishi were required to use commercially reasonable efforts, at their own expense, to develop, obtain regulatory approval for and commercialize difelikefalin in the United States and Japan, respectively. In addition, Cara provided Maruishi specific clinical development services for difelikefalin used in Maruishi’s field of use. Under the terms of the Maruishi Agreement, Cara was eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered, low double-digit royalties with respect to any sales of the licensed product sold in Japan by Maruishi, if any, and share in any sub-license fees. In September 2022, Maruishi submitted a New Drug Application in Japan for approval of difelikefalin injection for the treatment of pruritus in hemodialysis patients. In September 2023, Maruishi received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA IV Injection Syringe for the treatment of pruritus in hemodialysis patients. In November 2023, Cara entered into an API supply agreement with Maruishi for difelikefalin. In connection with the consummation of the Asset Disposition, Cara assigned the Maruishi Agreement and the API supply agreement with Maruishi to CSL Vifor (see Note 18, Subsequent Events). Chong Kun Dang Pharmaceutical Corporation (CKDP) In April 2012, Cara entered into a license agreement with CKDP (the “CKDP Agreement”) in South Korea, under which Cara granted CKDP an exclusive license to develop, manufacture and commercialize drug products containing difelikefalin in South Korea. Cara and CKDP are each required to use commercially reasonable efforts, at their respective expense, to develop, obtain regulatory approval for and commercialize difelikefalin in the United States and South Korea, respectively. In connection with the consummation of the Asset Disposition, Cara assigned the CKDP Agreement to CSL Vifor (see Note 18, Subsequent Events). Under the terms of the CKDP Agreement, Cara was eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered royalties, with percentages ranging from the high single digits to the high teens, based on net sales of products containing difelikefalin in South Korea, if any, and share in any sub-license fees.

Collaboration and Licensing Agreements

3 Months Ended

Mar. 31, 2025

Collaboration and Licensing Agreements.

11. Collaboration and Licensing Agreements

Vifor (International) Ltd. (Vifor International)

In October 2020, Cara entered into a license agreement with Vifor International (“Vifor Agreement No. 1”), under which Cara granted Vifor International an exclusive license solely in the United States to use, distribute, offer for sale, promote, sell and otherwise commercialize difelikefalin injection for all therapeutic uses relating to the inhibition, prevention or treatment of itch associated with pruritus in hemodialysis and peritoneal dialysis patients in the United States. Under Vifor Agreement No. 1, Cara retains all rights with respect to the clinical development of, and activities to gain regulatory approvals of, difelikefalin injection in the United States. In conjunction with the consummation of the Asset Disposition, Vifor Agreement No. 1 was terminated (see Note 18, Subsequent Events).

After the assignment of rights of Vifor Agreement No. 1 from Vifor International to Vifor Fresenius Medical Care Renal Pharma Ltd. in May 2022, Vifor Agreement No. 1 provided full commercialization rights in dialysis clinics to CSL Vifor in the United States under a profit-sharing arrangement. Pursuant to the profit-sharing arrangement, Cara was generally entitled to 60% of the net profits (as defined in Vifor Agreement No. 1) from sales of difelikefalin injection in the United States and CSL Vifor was entitled to 40% of such net profits (excluding sales to Fresenius Medical Center dialysis clinics, compensation for which was governed by Vifor Agreement No. 2, as defined below), subject to potential temporary adjustment in future years based on certain conditions. Under Vifor Agreement No. 1, in consideration of CSL Vifor’s conduct of the marketing, promotion, selling and distribution of difelikefalin injection in the United States, Cara paid a marketing and distribution fee to CSL Vifor based on the level of annual net sales. This fee as well as CSL Vifor’s cost of goods sold (“COGS”) were deducted from net sales in calculating the net profits that are subject to the profit-sharing arrangement under Vifor Agreement No. 1.

In addition, pursuant to Vifor Agreement No. 1, Cara was eligible to receive payments of up to $240,000 upon the achievement of certain sales-based milestones.

Cara retained the rights to make and have made difelikefalin injection (the “Licensed Product”) on a non-exclusive basis, in the United States for commercial sale of the Licensed Product for use in all therapeutic areas to prevent, inhibit or treat itch associated with pruritus in hemodialysis and peritoneal-dialysis patients (the “Field”) anywhere in the world and for supply of Licensed Product to CSL Vifor under the terms of a supply agreement (the “Vifor International Supply Agreement”) which was executed in September 2021. The supply price was Cara’s COGS, as calculated under GAAP, plus an agreed upon margin. The Vifor International Supply Agreement would co-terminate with Vifor Agreement No.

1. Cara also retained the rights to import, distribute, promote, sell and otherwise commercialize the Licensed Product on an exclusive basis outside of the Field either in or outside of the United States.

The Vifor International Supply Agreement is accounted for as a customer option that is not a material right because the selling price of the Licensed Product under the Vifor International Supply Agreement is Cara’s COGS plus an agreed upon margin, which is commensurate with the “COGS plus” model that Cara would charge other parties under similar agreements (the standalone selling price) and not at a discount. Therefore, the sale of commercial supply to CSL Vifor is not a performance obligation under Vifor Agreement No. 1 but rather the Vifor International Supply Agreement is a separate agreement from Vifor Agreement No. 1. The only performance obligation under the Vifor International Supply Agreement is the delivery of the Licensed Product to CSL Vifor for commercialization. In connection with the consummation of the Asset Disposition, the Vifor International Supply Agreement was terminated (see Note 18, Subsequent Events).

Vifor Fresenius Medical Care Renal Pharma Ltd.

In May 2018, Cara entered into a license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. (“Vifor Agreement No. 2”) under which Cara granted Vifor Fresenius Medical Care Renal Pharma Ltd. an exclusive, royalty-bearing license, or the Vifor License, to seek regulatory approval to commercialize, import, export, use, distribute, offer for sale, promote, sell and otherwise commercialize the Licensed Product in the Field worldwide (excluding the United States, Japan and South Korea) (the “Territory”). In connection with the consummation of the Asset Disposition, Vifor Agreement No. 2 was terminated (see Note 18, Subsequent Events).

Cara was eligible to receive from Vifor Fresenius Medical Care Renal Pharma Ltd. additional commercial milestone payments in the aggregate of up to $440,000, all of which are sales related. Cara was also eligible to receive tiered double-digit royalty payments based on annual net sales, as defined in Vifor Agreement No. 2, of difelikefalin injection in the licensed territories. Cara retained full commercialization rights for difelikefalin injection for the treatment of chronic kidney disease associated pruritus in the United States except in the dialysis clinics of FMCNA, where Vifor Fresenius Medical Care Renal Pharma Ltd. will promote difelikefalin injection under a profit-sharing arrangement (as defined in Vifor Agreement No. 2), based on net FMCNA clinic sales (as defined in Vifor Agreement No. 2) and Cara and Vifor Fresenius Medical Care Renal Pharma Ltd. were each entitled to 50% of such net profits, subject to potential adjustments in a calendar year based on certain conditions.

Cara retained the rights to make and have made the Licensed Product in the Territory for commercial sale by Vifor Fresenius Medical Care Renal Pharma Ltd. in the Field in or outside the Territory and for supply of Licensed Product to Vifor Fresenius Medical Care Renal Pharma Ltd. under the terms of a supply agreement (the “Vifor Supply Agreement”) which was executed in May 2020. The supply price was Cara’s COGS, as calculated under GAAP, plus an agreed upon margin. The Vifor Supply Agreement would co-terminate with Vifor Agreement No. 2.

The Vifor Supply Agreement is accounted for as a customer option that is not a material right because the selling price of the Licensed Product under the Vifor Supply Agreement is Cara’s COGS plus an agreed upon margin, which is commensurate with the “COGS plus” model that Cara would charge other parties under similar agreements (the standalone selling price) and not at a discount. Therefore, the sale of compound to Vifor Fresenius Medical Care Renal Pharma Ltd. is not a performance obligation under Vifor Agreement No. 2 but rather the Vifor Supply Agreement is a separate agreement from Vifor Agreement No. 2. The only performance obligation under the Vifor Supply Agreement is the delivery of the Licensed Product to Vifor Fresenius Medical Care Renal Pharma Ltd. for commercialization. In connection with the consummation of the Asset Disposition, the Vifor Supply Agreement was terminated (see Note 18, Subsequent Events).

Maruishi Pharmaceutical Co., Ltd. (Maruishi)

In April 2013, Cara entered into a license agreement with Maruishi (the “Maruishi Agreement”) under which Cara granted Maruishi an exclusive license to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and/or uremic pruritus in Japan. Maruishi has the right to grant sub-licenses in Japan, which entitled Cara to receive sub-license fees, net of prior payments made by Maruishi to Cara. Under the Maruishi Agreement, Cara and Maruishi were required to use commercially reasonable efforts, at their own expense, to develop, obtain regulatory approval for and commercialize difelikefalin in the United States and Japan, respectively. In addition, Cara provided Maruishi specific clinical development services for difelikefalin used in Maruishi’s field of use.

Under the terms of the Maruishi Agreement, Cara was eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered, low double-digit royalties with respect to any sales of the licensed product sold in Japan by Maruishi, if any, and share in any sub-license fees.

In September 2022, Maruishi submitted a New Drug Application in Japan for approval of difelikefalin injection for the treatment of pruritus in hemodialysis patients. In September 2023, Maruishi received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA IV Injection Syringe for the treatment of pruritus in hemodialysis patients. In November 2023, Cara entered into an API supply agreement with Maruishi for difelikefalin. In connection with the consummation of the Asset Disposition, Cara assigned the Maruishi Agreement and the API supply agreement with Maruishi to CSL Vifor (see Note 18, Subsequent Events).

Chong Kun Dang Pharmaceutical Corporation (CKDP)

In April 2012, Cara entered into a license agreement with CKDP (the “CKDP Agreement”) in South Korea, under which Cara granted CKDP an exclusive license to develop, manufacture and commercialize drug products containing difelikefalin in South Korea. Cara and CKDP are each required to use commercially reasonable efforts, at their respective expense, to develop, obtain regulatory approval for and commercialize difelikefalin in the United States and South Korea, respectively. In connection with the consummation of the Asset Disposition, Cara assigned the CKDP Agreement to CSL Vifor (see Note 18, Subsequent Events).

Under the terms of the CKDP Agreement, Cara was eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered royalties, with percentages ranging from the high single digits to the high teens, based on net sales of products containing difelikefalin in South Korea, if any, and share in any sub-license fees.