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Commitments and Contingencies
3 Months Ended
Mar. 31, 2025
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

12.

Commitments and Contingencies

 

Contingent Value Rights Agreement

 

Each CVR under the CVR Agreement entitles the holder to receive (i) certain cash payments from the net proceeds related to the disposition of Catalyst’s legacy assets, (ii) 100% of the excess cash (net of all current or contingent liabilities, including transaction-related expenses) retained by the Company in excess of $1.0 million as of the closing date of the transactions under the Business Combination Agreement, (iii) 100% of the amount actually received by the Company, net of expenses, pursuant to an asset purchase agreement Catalyst entered into with Vertex Pharmaceuticals Inc. (“Vertex”) in May 2022 and (iv) 100% of the excess amount, by which the preapproved costs to manage, negotiate, settle and finalize certain third party claims exceed the costs actually incurred with respect to such claims. The CVRs are not transferable, except in certain limited circumstances as provided for in the CVR Agreement, will not be certificated or evidenced by any instrument, and will not be registered with the SEC or listed for trading on any exchange.

 

In February 2023, Catalyst sold its legacy rare bleeding disorder program to GCBP. As a result, the Company distributed the net cash proceeds received from the GCBP asset sale of $0.2 million to the CVR Holders as well as

recorded a $4.5 million long-term CVR derivative liability for the future distribution of the hold-back amount to be received in May 2025. As of December 31, 2024, the carrying value of the CVR derivative liability was $5.0 million on the condensed consolidated balance sheet. In the first quarter of 2025 the Company received a $5.0 million hold-back payment from GCBP and, after deducting expenses, distributed the net amount to the CVR Holders. As of March 31, 2025, the Company does not have any outstanding balance related to CVR derivative liability. Refer to Note 3 — Fair Value Measurements and Financial Instruments for additional information regarding the CVR derivative liability and GCBP asset sale.

 

On October 30, 2023, pursuant to the CVR Agreement, the Company recorded a $1.1 million CVR excess closing cash payable upon closing of the Contributions. During the first quarter of 2024, the Company received a settlement related to the CVR litigation, and on August 26, 2024, it distributed approximately $12.6 million (or $0.40 per contingent value right) to the CVR Holders. Subsequent to the payment, the CVR Holders have received all requisite cash payable under the CVR Agreement and there are no outstanding distributions.

 

Litigation and Legal Matters

 

The Company is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse effect upon the Company’s condensed consolidated financial statements.

 

Purchasing Commitments

 

Property and Equipment

 

The Company’s commitments related to purchase of property and equipment contracted but not yet reflected in the condensed consolidated financial statements were $4.8 million as of March 31, 2025 and were expected to be incurred within one year.

 

Nintedanib IP Rights

In May 2024, the Company entered into an IP rights transfer agreement with a third party, Jiangsu Wangao Pharmaceuticals Co., Ltd., to acquire the intellectual property associated with Nintedanib (the “Nintedanib IP Rights”). The Nintedanib IP Rights are recorded as Technology rights in Intangible Assets in Note 5. As of March 31, 2025, the commercial sales of Nintedanib has not yet commenced.

 

According to the agreement, except for RMB 35.0 million, or approximately $4.9 million, based on the March 31, 2025 spot exchange rate, the Company is committed to additional annual payments over eight years following the commencement of commercial sales, which will be contingent consideration based on actual annual sales in future years. The contingent payment in the first year will be 5% of sales for that year minus RMB 10 million, or approximately $1.4 million, based on the March 31, 2025 spot exchange rate. The contingent payment in the second year will be 4% of sales for that year minus RMB 10 million, or approximately $1.4 million, based on the March 31, 2025 spot exchange rate. The contingent payment in the third year through the eighth year will be 3%, 2%, 2%, 1%, 1%, and 1% of sales in each year, respectively.

 

F351

 

In September 2020, Gyre Pharmaceuticals entered into an IP transfer agreement (the “F351 Transfer Agreement”) with GNI Japan and certain of its wholly owned subsidiaries (the “GNI Group”). According to the F351 Transfer Agreement, Gyre Pharmaceuticals acquired the exclusive right to use Hydronidone IP rights in mainland China and the right of first offer for the global IP rights (the “F351 IP Rights”).

 

Under the F351 Transfer Agreement, in exchange for the F351 IP Rights, Gyre Pharmaceuticals is obligated to pay GNI Group $4.6 million upon submission of the F351 New Drug Application (the “NDA”) to Center for Drug Evaluation of the NMPA of the PRC, $1.2 million after the NDA passes the NMPA’s Center for Food and Drug

Review and Inspection’s on-site registration inspection for the F351 product, and $6.9 million upon NMPA’s approval of the NDA. As of March 31, 2025, the payment conditions have not been met, and no payments have been made.

 

Research and Development Programs

 

In addition to the $12.7 million commitment to GNI for the F351 program, as of March 31, 2025, Gyre Pharmaceuticals has committed to allocate $20.0 million toward future research and development activities for various programs.

 

Indemnification Agreements

 

In the normal course of business, the Company enters into agreements that indemnify others for certain liabilities that may arise in connection with a transaction or certain events and activities. If the indemnified party were to make a successful claim pursuant to the terms of the indemnification, the Company may be required to reimburse the loss. These indemnifications are generally subject to various restrictions and limitations. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations.