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Collaborations, Licensing and Other Arrangements
12 Months Ended
Dec. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Collaborations, Licensing and Other Arrangements

11. Collaborations, Licensing and Other Arrangements

Revenue from collaborations and services were as follows (in thousands):

 

 

 

Year Ended December 31,

 

 

 

2024

 

 

2023

 

 

2022

 

UT CSA(1)

 

$

96,228

 

 

$

52,025

 

 

$

24,826

 

UT License Agreement (2)

 

 

2,865

 

 

 

782

 

 

 

2,426

 

Cipla License and Distribution Agreement

 

 

1,247

 

 

 

147

 

 

 

147

 

Amphastar co-promotion agreement

 

 

500

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

525

 

Total revenue from collaborations and services

 

$

100,840

 

 

$

52,954

 

 

$

27,924

 

_________________________

(1)
Amounts consist of revenue recognized for Manufacturing Services to UT for the periods presented.
(2)
Amounts consist of revenue recognized for Next-Gen R&D Services and R&D Services and License for the periods presented.

 

The activity related to deferred revenue and the related revenue recognized for collaborations and services is as follows (in thousands):

 

 

 

December 31, 2024

 

 

December 31, 2023

 

Deferred revenue:

 

 

 

 

 

 

Beginning balance

 

$

78,879

 

 

$

39,417

 

Additions

 

 

85,528

 

 

 

92,416

 

Collaborations and services revenue

 

 

(100,840

)

 

 

(52,954

)

Ending balance

 

$

63,567

 

 

$

78,879

 

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):

 

 

 

Year Ended December 31,

 

 

 

2024

 

 

2023

 

 

2022

 

Revenue from UT

 

 

 

 

 

 

 

 

 

UT CSA

 

$

96,228

 

 

$

52,025

 

 

$

24,826

 

UT License Agreement

 

 

2,865

 

 

 

782

 

 

 

2,426

 

Royalties(1)

 

 

102,335

 

 

 

71,979

 

 

 

15,599

 

Total revenue from UT

 

$

201,428

 

 

$

124,786

 

 

$

42,851

 

_________________________

(1)
Amounts consist of royalties associated with the UT License Agreement. The contract asset related to the royalties receivable of $24.3 million, $21.7 million and $9.1 million as of December 31, 2024, 2023 and 2022, respectively, was included in prepaid expense and other current assets in the consolidated balance sheets and collected in the following quarter.

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 Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to UT. The Company will sell product to UT under individual purchase orders which represent distinct performance obligations and is recognized upon transfer of control.

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.

The Company accounted for the December 2024 contract amendment as if it were part of the existing contract. The effect of the modification on the transaction price and the measure of progress towards completion was de minimis. Therefore, the modification did not result in a change in the activities and deliverables under the CSA.

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. Revenue is recognized at a point in time as services are rendered. Also during 2024, the Company and UT concluded the Next-Gen R&D Services performance obligation, which resulted in the recognition of $2.9 million of deferred revenue.

As of December 31, 2024, deferred revenue from UT consisted of $62.4 million, of which $12.3 million was classified as current and $50.1 million was classified as long-term on the consolidated balance sheet. As of December 31, 2023, deferred revenue consisted of $77.5 million, of which $8.9 million was classified as current and $68.6 million was classified as long-term on the consolidated balance sheet. The Company determined that the revenue recognition associated with the facility expansion should be combined with the Manufacturing Services performance obligation.

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 consolidated statements of operations. On February 28, 2023, the collaboration agreement was amended to extend the term through June 2024. In accordance with the amendment, the Company agreed to fund a minimum of $1.1 million to be expended on a revised development plan prepared by Thirona, of which $1.1 million had been funded through December 31, 2024.

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 shipments of product were made to Biomm during the year ended December 31, 2024, 2023 or 2022.

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 included in accounts receivable, net, in the consolidated balance sheets at December 31, 2024 and collaborations and services revenue in the consolidated statements of operations for the year then ended. The payment was received in the first quarter of 2025. 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 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 consolidated balance sheets. As of December 31, 2023, the deferred revenue balance was $1.4 million, of which $0.2 million is classified as current and $1.2 million is classified as long term in the 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 Amphastar is marketing Baqsimi (glucagon) nasal powder and the Company's sales force shall promote Baqsimi 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 (the "contract term"). 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 was recognized as revenue from collaborations and services in our consolidated statement of operations for the year ended December 31, 2024. The remaining $2.0 million will be recognized based on the measurement of progress as the performance obligation is satisfied through the end of the contract term.