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Collaborative Arrangement
12 Months Ended
Sep. 30, 2022
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Collaborative Arrangement

4. Collaborative Arrangement

On February 26, 2018, the Company entered into an agreement with Abbott whereby Abbott has exclusive worldwide commercialization rights for Surmodics' SurVeil DCB to treat the superficial femoral artery (the “Abbott Agreement”). A premarket approval (“PMA”) application for the SurVeil DCB was being evaluated by the U.S. Food and Drug Administration (“FDA”) as of September 30, 2022.

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 September 30, 2022, the Company has 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 upon completion of enrollment in the TRANSCEND clinical trial, (iii) $10.8 million milestone payment in fiscal 2020 upon receipt of Conformité Européenne Mark (“CE Mark”) approval prerequisite for commercialization of the SurVeil DCB in the European Union, and (iv) $15 million milestone payment in fiscal 2021 upon receipt by Abbott of the clinical study report and related materials from the TRANSCEND pivotal trial that demonstrated the primary safety and primary clinical endpoints were non-inferior to the control device. As of September 30, 2022, the Company may receive an additional contingent milestone payment of up to $30 million upon PMA of our SurVeil DCB. The milestone payment is reduced to $27 million (if PMA is received after December 31, 2022 but before June 30, 2023), and to $24 million (if PMA is received on or after June 30, 2023), pursuant to the terms of the Abbott Agreement. As of September 30, 2022, 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 September 30, 2022.

Revenue recognized from the Abbott Agreement totaled $5.7 million, $16.0 million and $12.0 million in fiscal 2022, 2021 and 2020, respectively. As of September 30, 2022, the Company had recognized total license fee revenue of $51.6 million from the Abbott Agreement. Revenue recognized from the Abbott Agreement, which was included in the respective beginning of fiscal year balances of deferred revenue on the consolidated balance sheets, totaled $5.7 million, $4.7 million and $5.0 million for fiscal 2022, 2021 and 2020, respectively. As of September 30, 2022 and 2021, total deferred revenue from the upfront and milestone payments received of $9.2 million and $14.9 million, respectively, was recorded on the consolidated balance sheets.

As of September 30, 2022, the estimated revenue expected to be recognized in future periods totaled approximately $9.2 million related to performance obligations that are unsatisfied for executed contracts with an original duration of one year or more. These remaining performance obligations relate to the Abbott Agreement, exclude the potential contingent milestone payment under the Abbott Agreement, and are expected to be recognized over the next three years as the services, which are primarily comprised of the R&D and Clinical Activities performance obligation in the Abbott Agreement, are completed. As of September 30, 2022, we expect to recognize approximately $4.1 million of these remaining performance obligations as revenue within one year, with the remaining $5.1 million over the subsequent, final two years of the TRANSCEND trial follow-up and clinical reporting period.

See Note 2 for further information regarding revenue recognition for the Abbott Agreement.