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Collaborations, Licensing and Other Arrangements | 6 Months Ended
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Jun. 30, 2025
Organization Consolidation And Presentation Of Financial Statements [Abstract] |
Collaborations, Licensing and Other Arrangements | 9. Collaborations, Licensing and Other Arrangements Revenue from collaborations and services were as follows (in thousands):
|  | Three Months Ended June 30, |  |  | Six Months Ended June 30, |
|  | 2025 |  |  | 2024 |  |  | 2025 |  |  | 2024 |
UT CSA(1) |  | $ | 22,224 |  |  | $ | 25,978 |  |  | $ | 51,042 |  |  | $ | 50,442 |
Amphastar co-promotion agreement |  |  | 500 |  |  |  | — |  |  |  | 1,000 |  |  |  | — |
Cipla License and Distribution Agreement |  |  | 37 |  |  |  | 36 |  |  |  | 73 |  |  |  | 73 |
Other |  |  | 84 |  |  |  | — |  |  |  | 106 |  |  |  | — |
UT License Agreement |  |  | — |  |  |  | — |  |  |  | — |  |  |  | 347 |
Total revenue from collaborations and services |  | $ | 22,845 |  |  | $ | 26,014 |  |  | $ | 52,221 |  |  | $ | 50,862 |
_________________________ (1) Amounts consist of revenue recognized for Manufacturing Services to UT for the periods presented. United Therapeutics License Agreement — In September 2018, the Company and UT entered into an exclusive global license and collaboration agreement (the “UT License Agreement”), pursuant to which UT is responsible for global development, regulatory and commercial activities with respect to Tyvaso DPI. Total revenue from UT was as follows (in thousands):
|  | Three Months Ended June 30, |  |  | Six Months Ended June 30, |
|  | 2025 |  |  | 2024 |  |  | 2025 |  |  | 2024 |
Revenue from UT |  |  |  |  |  |  |  |  |  |  |  |
Royalties(1) |  | $ | 31,228 |  |  | $ | 25,592 |  |  | $ | 61,233 |  |  | $ | 48,243 |
UT CSA |  |  | 22,224 |  |  |  | 25,978 |  |  |  | 51,042 |  |  |  | 50,442 |
UT License Agreement |  |  | — |  |  |  | — |  |  |  | — |  |  |  | 347 |
Total revenue from UT |  | $ | 53,452 |  |  | $ | 51,570 |  |  | $ | 112,275 |  |  | $ | 99,032 |
_________________________ (1) Amounts consist of royalties associated with the UT License Agreement. The contract assets related to the royalties is included in prepaid expense and other current assets in the condensed consolidated balance sheets. Pursuant to the UT License Agreement, the Company receives a 10% royalty on net sales of Tyvaso DPI. In December 2023, the Company sold a 1% royalty on future net sales of Tyvaso DPI to a royalty purchaser, with the Company retaining a 9% royalty. In August 2021, the Company and UT entered into the CSA, pursuant to which the Company is responsible for manufacturing and supplying to UT, and UT is responsible for purchasing from the Company on a cost-plus basis. In addition, UT is responsible for supplying treprostinil at its expense in quantities necessary to enable the Company to manufacture Tyvaso DPI as required by the CSA. The activities and deliverables under the CSA and UT License Agreement resulted in distinct performance obligations which include the: (1) R&D Services and License, (2) Next-Gen R&D Services, and (3) Manufacturing Services. The revenue recognized under the CSA for manufacturing services is comprised of the sale of product to UT, recognition of previously deferred revenue, as well as reimbursements from other agreements for individual performance obligations. The portion of revenue related to each deliverable included in UT CSA revenue (in thousands) is as follows:
|  | Three Months Ended June 30, |  |  | Six Months Ended June 30, |
|  | 2025 |  |  | 2024 |  |  | 2025 |  |  | 2024 |
UT CSA Revenue |  |  |  |  |  |  |  |  |  |  |  |
Sale of product(1) |  | $ | 18,704 |  |  |  | 21,400 |  |  |  | 43,818 |  |  |  | 42,943 |
Recognition of previously deferred revenue |  |  | 2,654 |  |  |  | 3,611 |  |  |  | 6,066 |  |  |  | 6,088 |
Other agreements |  |  | 866 |  |  |  | 967 |  |  |  | 1,158 |  |  |  | 1,411 |
Total UT CSA revenue |  | $ | 22,224 |  |  | $ | 25,978 |  |  | $ | 51,042 |  |  | $ | 50,442 |
_________________________ (1) Sale of product included revenue related to fully reimbursable costs associated with product sales and other miscellaneous charges of $1.2 million and $2.9 million for the three and six months ended June 30, 2024, and no ne in 2025. There have been various amendments to the UT License Agreement and the CSA since inception. As amended, the term of the CSA continues until December 31, 2031 (unless earlier terminated) and is thereafter renewed automatically for additional, successive two-year terms unless (i) UT provides notice to the Company at least 24 months in advance of such renewal that UT does not wish to renew the CSA or (ii) the Company provides notice to UT at least 48 months in advance of such renewal that the Company does not wish to renew the CSA. The Company and UT each have normal and customary termination rights, including termination for material breach that is not cured within a specific timeframe or in the event of liquidation, bankruptcy or insolvency of the other party. During 2024, the Company also entered into additional agreements for individual performance obligations which are accounted for separately as they are distinct from Manufacturing Services and offered at a standalone selling price, for which we received revenue of $0.9 and $1.2 million for the three and six months ended June 30, 2025 and $1.0 million and $1.4 million for the three and six months ended June 30, 2024, respectively. Revenue is recognized at a point in time as services are rendered. Also during 2024, the Company fully recognized the Next-Gen R&D Services performance obligation and the pre-production activities under the CSA, such as facility expansion services that were bundled services under the Manufacturing Services performance obligation. As of June 30, 2025, deferred revenue from UT consisted of $55.4 million, of which $10.9 million was classified as current and $44.5 million was classified as long-term on the condensed consolidated balance sheet. As of December 31, 2024, deferred revenue consisted of $62.4 million, of which $12.3 million was classified as current and $5 0.1 million was classified as long-term on the condensed consolidated balance sheet. The deferred revenue balance included $55.3 million and $61.3 million of UT funded pre-production activities under the CSA, such as facility expansion services and other administrative services as of June 30, 2025 and December 31, 2024, respectively. The Company determined that the deferred revenue should be combined with the Manufacturing Services performance obligation and relates solely to a single partially satisfied performance obligation pursuant to the CSA which will be recognized as product is delivered over the CSA term based on the measurement of progress. Thirona Collaboration Agreement — In June 2021, the Company and Thirona entered into a collaboration agreement to evaluate the therapeutic potential of Thirona’s compound for the treatment of fibrotic pulmonary diseases. If initial studies are promising, the Company can exercise certain rights to seek a full license to the compound for clinical development and commercialization. The parties will perform their respective obligations and provide reasonable support for research, clinical development and regulatory strategy. The collaboration agreement was accounted for under ASC 808, Collaborative Agreements; however, no consideration was exchanged between the parties. The costs incurred by the Company were expensed as R&D in the condensed consolidated statements of operations. Biomm Supply and Distribution Agreement — In May 2017, the Company and Biomm S.A. ("Biomm") entered into a supply and distribution agreement for the commercialization of Afrezza in Brazil. Under this agreement, Biomm was responsible for pursuing regulatory approvals of Afrezza in Brazil, including from the Agência Nacional de Vigilância Sanitária (“ANVISA”) and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos (“CMED”), both of which were received. Biomm commenced product sales in January 2020. No additional shipments of product were made to Biomm since 2020. Cipla License and Distribution Agreement — In May 2018, the Company and Cipla Ltd. (“Cipla”) entered into an exclusive agreement for the marketing and distribution of Afrezza in India and the Company received a $2.2 million nonrefundable license fee. Under the terms of the agreement, Cipla is responsible for obtaining regulatory approvals to distribute Afrezza in India and for all marketing and sales activities of Afrezza in India. The Company is responsible for supplying Afrezza to Cipla. The Company is entitled to an additional regulatory milestone payment, minimum purchase commitment revenue and royalties on Afrezza sales in India once cumulative gross sales have reached a specified threshold. In December 2024, the Central Drugs Standard Control Organisation ("CDSCO") in India approved Afrezza for adults and, accordingly, the Company was entitled to the regulatory milestone payment from Cipla totaling $1.1 million, which was recognized as revenue from collaborations and services in the year ended December 31, 2024. The Company expects to ship product once Cipla obtains the registration certificate and import license. The initial $2.2 million nonrefundable licensing fee was recorded in deferred revenue and is being recognized in net revenue – collaborations over 15 years, representing the estimated period to satisfy the performance obligation. As of June 30, 2025, the deferred revenue balance for Cipla was $1.1 million, of which $0.1 million was classified as current and $1.0 million was classified as long term in the condensed consolidated balance sheets. As of December 31, 2024, the deferred revenue balance was $1.2 million, of which $0.1 million was classified as current and $1.1 million was classified as long term in the condensed consolidated balance sheets. Amphastar — During the quarter ended December 31, 2024, the Company entered into a co-promotion agreement which provides the terms and conditions upon which the Company's sales force shall promote Baqsimi (glucagon) nasal powder to designated health care professionals where the Company currently promotes Afrezza. Amphastar is obligated to pay fixed quarterly payments to the Company through December 2025. Either party may terminate the agreement or suspend performance upon written notice to the other party at any time during the contract term. The co-promotion agreement may be renewed or extended only upon the mutual written agreement of both parties. The Company identified a single performance obligation that the Company will satisfy over time. The total transaction price of $2.5 million is considered fixed consideration of which $0.5 million and $1.0 million was recognized as revenue from collaborations and services in our condensed consolidated statement of operations in the three and six months ended June 30, 2025, respectively. The remaining $1.0 million will be recognized based on the measurement of progress as the performance obligation is satisfied through December 2025.

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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Topic 808 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Subparagraph (a) -Publisher FASB -URI https://asc.fasb.org/1943274/2147479402/808-10-50-1 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Topic 808 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Subparagraph (b) -Publisher FASB -URI https://asc.fasb.org/1943274/2147479402/808-10-50-1 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Name Accounting Standards Codification -Topic 808 -Publisher FASB -URI https://asc.fasb.org/808/tableOfContent + Details
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