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Collaborative Arrangement
12 Months Ended
Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Collaborative Arrangement

4. Collaborative Arrangement

On February 26, 2018, we entered into the Abbott Agreement under which Abbott has exclusive worldwide commercialization rights for Surmodics' SurVeil DCB to treat the superficial femoral artery. In June 2023, we received premarket approval (“PMA”) for the SurVeil DCB from the U.S. Food and Drug Administration (“FDA”), and the product may now be marketed and sold in the U.S. by Abbott. Under the Abbott Agreement, Abbott has the right to purchase commercial units of the SurVeil DCB from us. Upon shipment of SurVeil DCB units to Abbott, Surmodics will realize product revenue, which will include (i) an agreed-upon transfer price, and (ii) a share of net profits resulting from product sales by Abbott to third parties. As of September 30, 2023, Surmodics had not yet recognized any such SurVeil DCB product revenue on the consolidated statements of operations. Timing of commercialization in the U.S. is at the discretion of Abbott.

Under the Abbott Agreement, Surmodics is responsible for conducting all necessary clinical trials, including completion of the ongoing, five-year, 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.

As of September 30, 2023, Surmodics had received payments totaling $87.8 million under the Abbott Agreement, which consisted 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, (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, and (v) final milestone payment of $27 million in fiscal 2023 upon receipt of PMA for the SurVeil DCB from the FDA.

Refer to Note 3 for SurVeil DCB license fee revenue recognized in fiscal 2023, 2022 and 2021. As of September 30, 2023, the Company had recognized total SurVeil DCB license fee revenue of $81.2 million on the total $87.8 million in upfront and milestone payments received under the Abbott Agreement. As of September 30, 2023 and 2022, deferred revenue of $6.6 million and $9.2 million, respectively, was recorded on the consolidated balance sheets from the upfront and milestone payments received under 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 $4.6 million, $5.7 million and $4.7 million for fiscal 2023, 2022 and 2021, respectively.

As of September 30, 2023, the estimated revenue expected to be recognized in future periods totaled approximately $6.6 million related to performance obligations that are unsatisfied for executed contracts with an original duration of one year or more. These remaining performance obligations related to the Abbott Agreement and are expected to be recognized over the next two 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, 2023, we expected to recognize approximately $4.2 million of these remaining performance obligations as revenue within one year, with the remaining $2.4 million over the subsequent, final year of the TRANSCEND trial follow-up and clinical reporting period.

See Note 2 for further information regarding SurVeil DCB license fee revenue recognition.