CORRESP Filing
MANNKIND CORP
Date: June 5, 2025 · CIK: 0000899460 · Accession: 0001193125-25-135790
AI Filing Summary & Sentiment
File numbers found in text: 000-50865
Referenced dates: May 16, 2025
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CORRESP 1 filename1.htm CORRESP June 5, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Frank Wyman Angela Connell Re: MannKind Corporation Form 10-K for the Fiscal Year Ended December 31, 2024 Filed February 26, 2025 File No. 000-50865 Dear Frank Wyman and Angela Connell: We are writing in response to the comments received from the staff (the “ Staff ”) of the Securities and Exchange Commission (the “ Commission ”) by letter dated May 16, 2025 with respect to the above-referenced filing (the “ Form 10-K ”) of MannKind Corporation (the “ Company ”). For your convenience, we have repeated the Staff’s comments before the Company’s responses below. Form 10-K for Fiscal Year Ended December 31, 2024 Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 50 1. We note that sales of Tyvaso DPI under your Commercial Supply Agreement (CSA) with United Therapeutics (UT) account for the majority of your Collaboration and services revenue, which increased 90% from $53 million in 2023 to $100.9 million in 2024. Based on your disclosure on page 94 and Section 3.01 of the CSA included as an Exhibit to your filing, it appears that such sales are made to UT on a cost plus margin basis. Given that the increase in your Cost of collaboration revenue in 2024 was only 41% compared to the prior year, it would appear that you achieved higher margins on sales of Tyvaso DPI during 2024 than in 2023. However, your disclosure on page 50 attributes the increase in revenue solely to higher patient demand. Please clarify for us the factors underlying the increase in Collaboration and services revenue and revise your disclosure in future filings accordingly. Response : The Company respectfully acknowledges the Staff’s comment and clarifies that while product sales are made to UT on a cost plus margin basis, collaboration and service revenue also includes the recognition of deferred revenue for pre-production activities under the CSA, such as facility expansion and administrative services. Previously deferred amounts are being recognized as product is delivered over the CSA term based on the measurement of progress. There are no incremental material deferred costs that are associated with the deferred revenue. In future periodic reports filed with the Commission, the Company will provide the following revised disclosure to clarify the impact of the recognition of deferred revenue in the fluctuation of Collaboration and services revenue ( bolded text below represents proposed additions): U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences June 5, 2025 Page 2 Collaborations and Services - Net revenue from collaborations and services increased by $47.9 million, or 90%, for the year ended December 31, 2024 compared to the prior year. The increase in revenue was primarily attributable to increased manufacturing volume for product sold to UT and recognition of deferred revenue . Notes to Consolidated Financial Statements 2. Summary of Significant Accounting Policies Revenue Recognition - Collaboration and Services, page 79 2. You disclose that revenue under your CSA with UT is recognized for the supply of product at a point in time, once control has transferred to UT. In your auditors’ Critical Audit Matter discussion, they disclose that revenue is recognized based on the measure of progress as the performance obligation is satisfied and that forecasted revenue over the contract term is utilized in determining the measure of progress. Please revise your accounting policy disclosure in future filings to disclose the method used to measure revenue under your CSA as well as the significant judgments used in determining your measure of progress. Please also disclose how any changes in transaction price are recognized. Response : The Company respectfully acknowledges the Staff’s comment and clarifies that Collaboration and services revenue includes both the sale of product recognized in accordance with purchase orders for the supply of product and the recognition of previously deferred amounts for pre-production activities under the CSA, such as facility expansion and administrative services bundled under the Manufacturing Services performance obligation. Revenue is recognized for the supply of product at a point in time, once control is transferred to UT in accordance with the purchase orders from the customer which represents distinct contracts and performance obligations and previously deferred amounts related to the Manufacturing Services performance obligation are recognized as product is delivered over the CSA term based on measurement of progress. Please note the following disclosures presented in Footnote 2 with respect to recognition of sale of product (emphasis added in bold ): “Following the FDA’s approval of Tyvaso DPI, UT began issuing purchase orders for the supply of product, which represents distinct contracts and performance obligations under ASC 606. Revenue is recognized for the supply of product at a point in time, once control is transferred to UT .” Also, please note the following disclosure presented in Footnote 2 with respect to recognition of deferred revenue related to Manufacturing Services: “Revenue is recognized based on the measurement of progress as the performance obligation is satisfied and consideration received that does not meet the requirements to satisfy the revenue recognition criteria is recorded as deferred revenue.” U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences June 5, 2025 Page 3 In addition, please note the following disclosure presented in Footnote 11 with respect to recognition of deferred revenue related to Manufacturing Services and sale of product: “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 .” We have also disclosed the following in Footnote 11 regarding changes in transaction price: “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 .” However, in future periodic reports filed with the Commission, the Company will provide the following revised disclosure to clarify the impact of the recognition of deferred revenue in the fluctuation of Collaboration and services revenue ( bolded text below represents proposed additions): Revenue Recognition - Collaborations and Services - The Company enters into licensing, research or other agreements under which the Company licenses certain rights to its product candidates to third parties, conducts research or provides other services to third parties. The terms of these arrangements may include, but are not limited to payment to the Company of one or more of the following: up-front license fees; development, regulatory, and commercial milestone payments; payments for commercial manufacturing and clinical supply services the Company provides; and royalties on net sales of licensed products and sublicenses of the rights. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment such as determining the performance obligation in the contract and determining the stand-alone selling price for each performance obligation identified in the contract. With respect to the Company’s significant collaboration and service agreement with UT that includes a long-term commercial supply agreement (as amended, the “CSA”), the Company has identified three distinct performance obligations: (1) the license, supply of product to be used in clinical development, and continued development and approval support for Tyvaso DPI (“R&D Services and License”); (2) development activities for the next generation of the product (“Next-Gen R&D Services”); and (3) a material right associated with current and future manufacturing and supply of product (“Manufacturing Services”). Pre-production activities under the CSA, such as facility expansion services and other administrative services, were considered bundled services under the Manufacturing Services performance obligation as required by ASC 606 , which were recorded as deferred revenue . Following the FDA’s approval of Tyvaso DPI, UT began issuing purchase orders for the supply of product, which represents distinct contracts and performance obligations under ASC 606. Revenue is recognized for the supply of product at a point in time, once control is transferred to UT, and deferred revenue is recognized as product is delivered over the CSA term based on the estimate of the measurement of progress . See Note 11 - Collaborations, Licensing and Other Arrangements. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences June 5, 2025 Page 4 If an arrangement has multiple performance obligations, the allocation of the transaction price is determined from observable market inputs, and the Company uses key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. Revenue is recognized based on the measurement of progress as the performance obligation is satisfied and consideration received that does not meet the requirements to satisfy the revenue recognition criteria is recorded as deferred revenue. Current deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. For further information, see Note 11 - Collaborations, Licensing and Other Arrangements. The Company recognizes upfront license payments as revenue upon delivery of the license only if the license is determined to be a separate unit of accounting from the other undelivered performance obligations. The undelivered performance obligations typically include manufacturing or development services or research and/or steering committee services. If the license is not considered as a distinct performance obligation, then the license and other undelivered performance obligations would be evaluated to determine if such should be accounted for as a single unit of accounting. If concluded to be a single performance obligation, the transaction price for the single performance obligation is recognized as revenue over the estimated period of when the performance obligation is satisfied. If the license is considered to be a distinct performance obligation, then the estimated revenue is included in the transaction price for the contract, which is then allocated to each performance obligation based on the respective standalone selling prices. Whenever the Company determines that an arrangement should be accounted for over time, the Company determines the period over which the performance obligations will be performed, and revenue will be recognized over the period the Company is expected to complete its performance obligations. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement, including estimating future revenue to be earned over the CSA contract term to determine the amount of deferred revenue to be recognized in the period . The Company’s collaboration agreements typically entitle the Company to additional payments upon the achievement of development, regulatory and sales milestones. If the achievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaboration consideration, such as upfront fees and research funding, in the Company’s revenue calculation. If these milestones are not considered probable at the inception of the collaboration, the milestones will typically be recognized in one of two ways depending on the timing of when the milestone is achieved. If the milestone is improbable at inception and subsequently deemed probable of achievement, such will be added to the transaction price, resulting in a cumulative adjustment to revenue. If the milestone is achieved after the performance period has been completed and all performance obligations have been delivered, the Company will recognize the milestone payment as revenue in its entirety in the period the milestone was achieved. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences June 5, 2025 Page 5 The Company’s collaboration agreements, for accounting purposes, represent contracts with customers and therefore are not subject to accounting literature on collaboration agreements. The Company grants licenses to its intellectual property, supplies raw materials, semi-finished goods or finished goods, provides research and development services and offers sales support for the co-promotion of products, all of which are outputs of the Company’s ongoing activities, in exchange for consideration. Accordingly, the Company concluded that its collaboration agreements must generally be accounted for pursuant to ASC 606. For collaboration agreements that allow collaboration partners to select additional optioned products or services, the Company evaluates whether such options contain material rights (i.e., have exercise prices that are discounted compared to what the Company would charge for a similar product or service to a new collaboration partner). The exercise price of these options includes a combination of licensing fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, the Company concludes the option does not contain a material right, and therefore is not included in the transaction price at contract inception. The Company assessed the CSA agreement with UT and determined that a material right existed for the manufacturing services performance obligation. The transaction price is allocated to the material right as well as the remaining performance obligations in accordance with ASC 606. The Company also evaluates grants of additional licensing rights upon option exercises to determine whether such should be accounted for as separate contracts. Any changes in transaction price is assessed by management as follows: • To the extent the change in estimated variable consideration relates to performance obligations that have been partially or fully satisfied, the effect of the change is recognized as an adjustment to revenue in the period of the change. This adjustment is recorded on a cumulative catch-up basis, reflecting the amount of revenue that would have been recognized if the revised estimate had been used since contract inception. • To the extent the change in estimated variable consideration relates to performance obligations that have not yet been satisfied, the effect of the change is recognized prospectively over the remaining performance period. 3. Pulmatrix Transaction, page 85 3. Please provide a detailed analysis supporting your accounti