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Collaborations, Licensing and Other Arrangements
12 Months Ended
Dec. 31, 2025
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,

 

 

 

2025

 

 

2024

 

 

2023

 

UT CSA(1)

 

$

102,385

 

 

$

96,228

 

 

$

52,025

 

Amphastar co-promotion agreement

 

 

2,000

 

 

 

500

 

 

 

 

Cipla License and Distribution Agreement

 

 

1,222

 

 

 

1,247

 

 

 

147

 

Other

 

 

106

 

 

 

 

 

 

 

UT License Agreement

 

 

1,000

 

 

 

2,865

 

 

 

782

 

Total revenue from collaborations and services

 

$

106,713

 

 

$

100,840

 

 

$

52,954

 

_________________________

(1)
Amounts consist of revenue recognized for Manufacturing Services to UT for the periods presented.

 

The activities and ending deferred balance for collaborations and services revenue is as follows (in thousands):

 

 

December 31, 2025

 

 

December 31, 2024

 

Deferred revenue:

 

 

 

 

 

 

Beginning balance

 

$

63,567

 

 

$

78,879

 

Additions

 

 

93,454

 

 

 

85,528

 

Upfront and milestone payments

 

 

5,000

 

 

 

 

Collaborations and services revenue

 

 

(106,713

)

 

 

(100,840

)

Ending balance

 

$

55,308

 

 

$

63,567

 

 

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,

 

 

 

2025

 

 

2024

 

 

2023

 

Revenue from UT

 

 

 

 

 

 

 

 

 

Royalties(1)

 

$

128,116

 

 

$

102,335

 

 

$

71,979

 

UT CSA

 

 

102,385

 

 

 

96,228

 

 

 

52,025

 

UT License Agreement

 

 

1,000

 

 

 

2,865

 

 

 

782

 

Total revenue from UT

 

$

231,501

 

 

$

201,428

 

 

$

124,786

 

_________________________

(1)
Amounts consist of royalties associated with the UT License Agreement. The contract asset related to the royalties receivable of $30.2 million, $24.3 million and $21.7 million as of December 31, 2025, 2024 and 2023, 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 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:

 

 

Year Ended December 31,

 

 

 

2025

 

 

2024

 

 

2023

 

UT CSA Revenue

 

 

 

 

 

 

 

 

 

Sale of product(1)

 

 

88,581

 

 

 

77,006

 

 

 

49,289

 

Recognition of previously deferred revenue

 

 

12,201

 

 

 

12,170

 

 

 

2,736

 

Other agreements

 

 

1,603

 

 

 

7,052

 

 

 

 

Total UT CSA revenue

 

$

102,385

 

 

$

96,228

 

 

$

52,025

 

 

(1)
Sale of product included revenue related to fully reimbursable costs associated with product sales and other miscellaneous charges of $0.9 million and $9.4 million for the years ended December 31, 2025 and 2024, respectively.

There have been various amendments to 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 recognized revenue of $1.6 million and $7.1 million for the years ended December 31, 2025 and 2024, respectively. There was no revenue recognized from additional agreements for the year ended December 31, 2023. 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. The pre-production activities under the CSA, such as facility expansion services that were bundled services under the Manufacturing Services performance obligation were completed in 2024 and are being amortized over the CSA contractual term. Historically, the Company has also fully recognized revenue related to R&D Services and License performance obligation, except for royalties which is recognized on a sales-based or usage-based royalty method.

Under the terms of the UT License Agreement, UT has an option to develop additional dry powder inhalation therapies. In August 2025, UT exercised its right, which was memorialized in an amendment to the UT License Agreement (the "First Amendment"), and is treated as a separate contract for revenue recognition purposes under ASC 606. Under the First Amendment, the Company will formulate MNKD-1501, an investigational molecule using its proprietary Technosphere platform, and United Therapeutics will conduct preclinical and clinical development. Per the First Amendment, the Company received an upfront payment of $5.0 million in 2025 and is eligible to receive up to $35.0 million in development milestones, of which approximately $10.0 million is probable of being earned based on the current stage of development and achievement criteria. The remaining $30.0 million in development milestones is considered constrained due to the inherent uncertainty in the timing and likelihood of achieving the associated milestones. The Company is also eligible to receive 10% royalties on net sales of any resulting product. As of December 31, 2025, $1.0 million of the initial upfront payment was recognized as revenue, based on the input measure of progress, and the remaining $4.0 million is included within deferred revenue - short term on the Company's consolidated balance sheets.

As of December 31, 2025, deferred revenue from UT consisted of $55.3 million, of which $15.3 million was classified as current and $40.0 million was classified as long-term on the 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 $50.1 million was classified as long-term on the consolidated balance sheet. The deferred revenue balance included $52.2 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 December 31, 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 using an output method based on an estimate of measurement of progress as units of product are delivered over the CSA term.

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 had proven promising, the Company would have had the rights to seek a full license to the compound for clinical development and commercialization. The parties performed their respective obligations and provided 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. In September 2025, Thirona initiated a cessation of operations following recent clinical trial results. The Company does not anticipate additional work to be performed or expenses to be incurred related to this agreement.

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, and began recording commercial product sales from this agreement in the fourth quarter of 2025. 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.

As of December 31, 2024, the deferred revenue balance related to the $2.2 million nonrefundable license fee 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. The $1.2 million remaining balance was fully recognized in net revenue – collaborations as of December 31, 2025, since the performance obligation was deemed to have been met. The Company recorded $0.6 million of revenue from commercial product sales to Cipla in India for the year ended December 31, 2025. There were no commercial product sales to India in 2024 or 2023.

Amphastar — In November 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. Per the terms of the co-promotion agreement, Amphastar was obligated to pay fixed quarterly payments to the Company through December 2025. Either party could 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. In December 2025, the first amendment to the co-promotion agreement was executed which extends the term to December 31, 2026. All other terms of the agreement remain in effect and unchanged.

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 $2.0 million and $0.5 million was recognized as revenue from collaborations and services in our consolidated statement of operations for the years ended December 31, 2025 and 2024, respectively.