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Collaborative Arrangement | 6 Months Ended
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Mar. 31, 2023
Organization Consolidation And Presentation Of Financial Statements [Abstract] |
Collaborative Arrangement | 3. Collaborative Arrangement On February 26, 2018, the Company entered into an agreement with Abbott Vascular, Inc. (“Abbott”) whereby Abbott has exclusive worldwide commercialization rights for Surmodics' SurVeil TM drug-coated balloon (“DCB”) to treat the superficial femoral artery (the “Abbott Agreement”). In accordance with the Abbott Agreement, the Company has filed a premarket approval (“PMA”) application for the SurVeil DCB with the U.S. Food and Drug Administration (“FDA” or the “Agency”) as of March 31, 2023. In January 2023, the FDA issued a letter to the Company indicating that the PMA application was not approvable based on the information submitted to the Agency to that time. Following receipt of the letter, the Company has been in communications with the FDA to obtain clarity on the requirements to put the application in approvable form. The Company plans to prepare an amendment to its PMA application based on its communications with the FDA. Surmodics is responsible for conducting all necessary clinical trials and other activities required to achieve U.S. regulatory clearance for the SurVeil DCB, including completion of the ongoing TRANSCEND pivotal clinical trial. Abbott and Surmodics participate on a joint development committee charged with providing guidance on the Company’s clinical and regulatory activities with regard to the SurVeil DCB product. Upon receipt of U.S. regulatory approval for our SurVeil DCB, Abbott will have the right to purchase commercial units from the Company, and Surmodics will realize revenue from product sales to Abbott at an agreed-upon transfer price, as well as a share of net profits resulting from third-party product sales by Abbott. As of March 31, 2023, the Company had received payments totaling $60.8 million under the Abbott Agreement, which consist of the following: (i) $25 million upfront fee in fiscal 2018, (ii) $10 million milestone payment in fiscal 2019, (iii) $10.8 million milestone payment in fiscal 2020, and (iv) $15 million milestone payment in fiscal 2021. As of March 31, 2023, the Abbott Agreement provides that the Company may receive an additional contingent milestone payment upon PMA of our SurVeil DCB of $27 million (if PMA is received prior to June 30, 2023) or $24 million (if PMA is received on or after June 30, 2023). As of March 31, 2023, consideration from this potential regulatory milestone was fully excluded from the contract price (i.e., deemed fully constrained) due to the high level of uncertainty of achievement as of March 31, 2023. If PMA is not received by December 31, 2023, Abbott may terminate the Abbott Agreement and would have no further obligation to make the potential regulatory milestone payment after termination. In the period of termination, deferred revenue on the condensed consolidated balance sheets related to payments received under the Abbott Agreement would be recognized as revenue. Revenue recognized from the Abbott Agreement totaled $1.3 million and $1.4 million for the three months ended March 31, 2023 and 2022, respectively, and $2.6 million for both the six months ended March 31, 2023 and 2022. The amount of revenue recognized from the Abbott Agreement that was included in the respective beginning of fiscal year balances of deferred revenue on the condensed consolidated balance sheets totaled $2.6 million for both the six months ended March 31, 2023 and 2022. As of March 31, 2023 and September 30, 2022, deferred revenue on the condensed consolidated balance sheets included $6.6 million and $9.2 million, respectively, related to payments received under the Abbott Agreement. The $6.6 million in deferred revenue as of March 31, 2023, which represents the Company’s performance obligations that are unsatisfied for executed contracts with an original duration of one year, is expected to be recognized as revenue over the next three years through fiscal 2025 as services, principally the TRANSCEND clinical trial, are completed.

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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 -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (a) -URI https://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (b) -URI https://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -URI https://asc.fasb.org/topic&trid=5833765 + Details
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