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Revenue from Contracts with Customers
 9 Months Ended
Sep. 30, 2025
Revenue from Contracts with Customers  
Revenue from Contracts with Customers

8.Revenue from Contracts with Customers

Kaken License Agreement

On August 6, 2025, the Company entered into the Kaken License Agreement with Kaken Pharmaceutical, Co., Ltd. (“Kaken”), pursuant to which the Company granted an exclusive license under certain patent rights and know-how controlled by the Company for Kaken to develop, package, and commercialize navenibart, a long-acting investigational monoclonal antibody inhibitor of plasma kallikrein (the “Navenibart Licensed Product”), for the prevention of HAE attacks in humans (the “Field”), in Japan.

Under the terms of the Kaken License Agreement, the Company will receive an upfront payment of $16.0 million, with a potential for an additional $16.0 million in total commercialization and sales milestones. In addition to these payments, on a Navenibart Licensed Product-by- Navenibart Licensed Product basis, the Company is eligible for tiered royalties, with the royalty rate as a percentage of net sales from the mid-teens to 30%. Kaken’s royalty payment obligations commence on the first commercial sale of each Navenibart Licensed Product in Japan and continue until the latest of (i) the expiration of the last to expire valid claim of specified Company patents rights covering such Navenibart Licensed Product in Japan, (ii) the expiration of the last to expire regulatory exclusivity with respect to such Navenibart Licensed Product in Japan, and (iii) ten (10) years following the first commercial sale of such Navenibart Licensed Product in Japan (each such term with respect to a Navenibart Licensed Product, the “Royalty Term”). Pursuant to the terms of the Kaken License Agreement, Kaken will also provide support for the Company’s ALPHA-ORBIT Phase 3 trial in Japan, be responsible for regulatory submissions in Japan, and reimburse the Company for a portion of the costs of the navenibart Phase 3 program. Kaken is obligated to use commercially reasonable efforts to obtain regulatory approval and reimbursement approval for, and commercialize, at least one Navenibart Licensed Product in the Field in Japan.

Unless earlier terminated, the Kaken License Agreement will expire on the expiration of the last-to-expire Royalty Term. The Kaken License Agreement may be terminated by either party for the other party’s uncured material breach, insolvency or bankruptcy. Additionally, Kaken may terminate the Kaken License Agreement upon 30 days’ notice for a material safety issue, or at its convenience with 90 days’ notice.

The Company evaluated the Kaken License Agreement and concluded that the agreement is subject to ASC 606 as a contract with a customer and that any future potential revenue will be recorded in accordance with ASC 606. The Company identified two performance obligations in the Kaken License Agreement including performance of research and development services and delivery of the license.

The transaction price has been allocated to performance of research and development services and delivery of the license on a relative standalone selling price basis. The transaction price at inception was approximately $23.0 million including fixed consideration consisting of the upfront fee of $16.0 million and variable consideration of $7.0 million relating to the estimated reimbursement of research and development services to be incurred. The amount of variable consideration was estimated using the expected value method. The remaining variable consideration of $16.0 million in total commercialization and sales milestones and sales-based royalties were excluded from the transaction price and considered constrained at inception and will be recognized when the related sales occur. The Company re-evaluates the transaction price at the end of each reporting period and adjusts the estimate as changes in circumstances occur. As of September 30, 2025, the Company allocated $20.6 million of the transaction price to the research and development services and $2.4 million to delivery of the license.

Revenue allocated to the research and development services is recognized as the Company satisfies its performance obligations of conducting the Phase 3 trials of navenibart and development of a prefilled syringe and autoinjector device. Revenue allocated to research and development services is recognized using the input method based on costs incurred to provide the services as the level of costs incurred over-time. Revenue allocated to the license is recognized when control of the Navenibart Licensed Product is transferred to Kaken at a point in time upon delivery of results from the ALPHA-ORBIT Phase 3 trial.

Accounts receivable were $17.2 million as of September 30, 2025 and consist of a $16.0 million upfront payment and reimbursements due for a portion of the Phase 3 program costs by Kaken to the Company. There were no accounts receivable as of December 31, 2024.

During the three and nine months ended September 30, 2025, the Company recognized $0.7 million of collaboration revenue related to the Kaken License Agreement. There was no revenue recognized during the three and nine months ended September 30, 2024. As of September 30, 2025, the Company recorded $16.5 million of deferred revenue related to the upfront payment and cost sharing due from Kaken, of which $4.5 million is classified as current and $12.0 million is classified as long-term on the Company’s consolidated balance sheets respectively.