Collaboration agreements | Collaboration agreements GSK On August 6, 2022, the Company entered into a Collaboration, Option and License Agreement (the "GSK Agreement") with GlaxoSmithKline Intellectual Property (No. 4) Limited ("GSK"), pursuant to which the Company granted GSK an exclusive option to obtain an exclusive license (the “Option”) to co-develop and to commercialize products containing XMT-2056 (the "Licensed Products"), exercisable within a specified time period (the “Option Period”) after the Company delivers to GSK data resulting from completion of dose escalation with enrichment for breast cancer patients in a Phase 1 single-agent clinical trial of XMT-2056. GSK’s exercise of the Option may require clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Clearance” and GSK’s exercise of the Option following any applicable HSR Clearance, the “GSK Option Exercise”). Prior to the GSK Option Exercise, the Company will lead and will be responsible for the costs of manufacturing, research, and early clinical development related to its XMT-2056 program. After the GSK Option Exercise, if any, GSK has the right to elect to manufacture XMT-2056, and GSK and the Company will co-develop XMT-2056 aimed at the approval of Licensed Product(s) in the United States and the European Union, with GSK being responsible for the majority of the development costs. GSK will be responsible for all development costs aimed solely at gaining approval outside the United States and European Union. Pursuant to the GSK Agreement, following the GSK Option Exercise and subject to certain exceptions and specified payment obligations, the Company’s aggregate shared development costs are capped at a fixed amount, with any amounts in excess to be borne by GSK unless and until the Company exercises its option to receive (or bear) a specified share of U.S. profits (or losses) for any Licensed Products (“Profit Share Election”). The excess development costs will accrue interest as specified in the GSK Agreement and will later either be repaid by the Company or offset against future regulatory and sales milestones or royalty payments that may become due to the Company. If the Company exercises its Profit Share Election, the cap on the Company’s share of development costs shall no longer apply, and the Company must pay any then-outstanding excess plus accrued interest costs. Additionally, if the Company exercises its Profit Share Election, it may also simultaneously elect to co-promote any Licensed Products in the United States. Pursuant to the GSK Agreement, GSK paid the Company a non-refundable, upfront fee of $100.0 million in August 2022. Following the GSK Option Exercise, if any, GSK is obligated to pay the Company an option exercise payment of $90.0 million (the "Option Payment"). The Company is eligible to receive future development, regulatory, and commercial milestone payments up to approximately $1.3 billion and, if the Company does not exercise its Profit Share Election, tiered royalties up to the mid-twenty percent range based on global sales of Licensed Products. Included in the aggregate milestone payments amount is $30 million that the Company is eligible to earn upon the satisfaction of early clinical development milestones that may occur prior to the GSK Option Exercise. If the Company exercises its Profit Share Election, the Company will be eligible to receive reduced development, regulatory, and commercial milestone payments and reduced royalty rates on sales outside of the United States. Whether or not the Company exercises its Profit Share Election, GSK will be responsible for certain milestone payments or royalties due to specified third parties with which the Company currently has agreements that relate to the XMT-2056 program. The GSK Agreement will terminate at the end of the Option Period if GSK does not exercise its Option. In the event of the GSK Option Exercise, unless earlier terminated, the GSK Agreement will continue in effect until the date on which the royalty term and all payment obligations with respect to all Licensed Products in all countries have expired. Accounting Analysis The Company assessed the GSK Agreement in accordance with ASC 606 and concluded that the contract counterparty, GSK, is a customer. The Company identified the following two material performance obligations under the GSK Agreement: (i) development activities, including manufacturing, research and early clinical development activities, necessary to deliver the package of data, information and materials specified in the GSK agreement (the "Development Activities") and (ii) the Option to co-develop and to commercialize Licensed Products (the "License Option"). The Company concluded that the Development Activities are one distinct performance obligation, as the underlying activities are not distinguishable in the context of the contract and are inputs to an integrated development program that will generate data and information providing value to GSK in determining whether to exercise the Option. The License Option is considered a material right as the value of the license exceeds the Option Payment, and is therefore a distinct performance obligation. In accordance with ASC 606, the Company determined that the initial transaction price under the GSK Agreement equals $100.0 million, consisting of the upfront, non-refundable and non-creditable payment paid by GSK. None of the early clinical development milestones that may occur prior to the GSK Option Exercise have been included in the initial transaction price, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including stage of development and the remaining risks associated with the development required to achieve the milestones, as well as whether the achievement of the milestones is outside the control of the Company or GSK. The GSK Option payment is excluded from the initial transaction price at contract inception along with any future development, regulatory, and commercial milestone payments (including royalties) following the GSK Option Exercise. Consistent with the allocation objective under ASC 606, the Company allocated the $100.0 million fixed upfront payment in the transaction price to the Development Activities and the License Option based on each performance obligation’s relative standalone selling price. The standalone selling price for the Development Activities was calculated using a cost-plus margin approach for the estimated pre-option development timeline. For the standalone selling price of the License Option, the Company utilized an income-based approach which included the following key assumptions: post-option development timeline and costs, revenue forecast, discount rates and probabilities of technical and regulatory success. The Company is recognizing revenue related to the Development Activities performance obligation over the estimated period of the pre-option development using a proportional performance model as the underlying activities are performed. Th e C ompany measures proportional performance based on the costs incurred relative to the total costs expected to be incurred. The Company deferred revenue recognition related to the License Option. If the License Option is exercised and GSK obtains an exclusive license, the Company will recognize revenue as it fulfills its obligations under the GSK Agreement. If the Option is not exercised, the Company will recognize the entirety of the revenue in the period when the Option expires. During the years ended December 31, 2023 and 2022, the Company recorded collaboration revenue of $3.4 million and $2.0 million, respectively, related to its efforts under the GSK Agreement. As of December 31, 2023 and 2022 , the Company had recorded $94.6 million and $98.0 million, respectively, in deferred revenue related to the unsatisfied performance obligations under the GSK Agreement. This deferred revenue will be recognized over the remaining performance period and classified as current or noncurrent on the consolidated balance sheets based upon the expected timing of satisfaction of the performance obligations. Johnson & Johnson In February 2022, the Company entered into a research collaboration and license agreement with Janssen Biotech Inc. ("Johnson & Johnson" and such agreement, as amended on July 14, 2023 and September 25, 2023, the "Johnson & Johnson Agreement") focused on the research, development and commercialization of novel ADCs for three oncology targets by leveraging Mersana’s ADC expertise and Dolasynthen platform with Johnson & Johnson’s proprietary antibodies. Upon execution of the Johnson & Johnson Agreement, the Company received a non-refundable upfront payment of $40.0 million from Johnson & Johnson. Pursuant to the Johnson & Johnson Agreement, the Company granted Johnson & Johnson two exclusive, nontransferable, worldwide licenses - a research license and a commercialization license (together, the "Johnson & Johnson Licenses"). The research license that forms a part of the Johnson & Johnson Licenses provides Johnson & Johnson, on a target-by-target basis, rights under the Company’s technology and the Company’s interest in the technology developed jointly through the collaboration solely to conduct Johnson & Johnson’s activities under the research and Chemistry, Manufacturing and Controls ("CMC") plans with respect to each target. The commercialization license that forms a part of the Johnson & Johnson Licenses is a royalty-bearing license granted on a target-by-target basis under the Company’s technology and the Company’s interest in the technology developed jointly through the collaboration to develop, manufacture, commercialize and otherwise exploit licensed ADCs and any licensed products containing licensed ADCs directed toward a target. Johnson & Johnson may select up to three targets and may substitute each target once prior to a substitution deadline. Johnson & Johnson is not required to pay a fee for its first substitution right, but must pay a one-time fee for access to the subsequent substitution rights following its exercise of its second substitution right. During the year ended December 31, 2023, Johnson & Johnson exercised its first substitution right for a certain target. Pursuant to mutually agreed research and CMC plans, the Company agreed to perform bioconjugation, production development, preclinical manufacturing, and certain related research and preclinical development activities, in order to progress the targets through investigational new drug application ("IND") submission for further development, manufacture and commercialization by Johnson & Johnson. Johnson & Johnson will have sole responsibility for IND-enabling studies, IND submission, clinical development, regulatory activities and commercialization of the licensed ADCs. Both the Company and Johnson & Johnson will have equal representation on a Joint Research Committee and Joint Manufacturing Committee to oversee the research and CMC activities. The Company estimates that its activities under the research plans for the targets will be performed into 2025. Johnson & Johnson is required to pay for the Company's CMC activities at agreed upon rates. Assuming successful development and commercialization of all three targets by Johnson & Johnson, the Company is eligible to receive up to $505 million in development and regulatory milestones and $530 million in sales milestones, as well as tiered mid single-digit to low double-digit royalties on aggregate net sales of the ADC products. Unless earlier terminated, the Johnson & Johnson Agreement will expire upon the expiration of the last royalty term for a product under the Johnson & Johnson Agreement. The Johnson & Johnson Agreement contains customary provisions for termination by either party, including in the event of breach of the Johnson & Johnson Agreement, subject to cure, by Johnson & Johnson for convenience and by the Company upon a challenge of the licensed patents, and customary provisions regarding the effects of termination. Johnson & Johnson may request that the Company perform clinical manufacturing services under a separate clinical supply agreement. Johnson & Johnson may also request that the Company perform a technology transfer of bioconjugation and manufacturing process technology, at Johnson & Johnson's cost, at an agreed upon rate. Accounting Analysis The Company assessed the Johnson & Johnson Agreement in accordance with ASC 606 and concluded that the contract counter party, Johnson & Johnson, is a customer. The Company identified the following seven material performance obligations under the Johnson & Johnson Agreement: (i) exclusive Johnson & Johnson Licenses and research activities for each of the three designated targets, (ii) CMC activities for each of the three designated targets and (iii) the first target substitution right. The Company concluded that the Johnson & Johnson Licenses and research activities are one combined performance obligation for each target as the Johnson & Johnson Licenses are not capable of being distinct from the research activities given their proprietary nature. The CMC activities are considered a distinct performance obligation for each target as the activities could be performed by a third-party provider. The first target substitution right is considered a material right as there is no option exercise fee and, as such, is a distinct performance obligation. In accordance with ASC 606, the Company determined that the initial transaction price under the Johnson & Johnson Agreement equals $40.0 million, consisting of the upfront, non-refundable and non-creditable payment. None of the development and the regulatory milestones were included in the initial transaction price, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including stage of development and the remaining risks associated with the development required to achieve the milestones, as well as whether the achievement of the milestones is outside the control of the Company or Johnson & Johnson. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as such milestones were determined to relate predominantly to the license granted to Johnson & Johnson and therefore have also been excluded from the transaction price. As of December 31, 2023, the revised total transaction price for the Johnson & Johnson Agreement was $48.0 million. During 2023, the Company revised the estimated transaction price by $6.0 million based on the reassessment of the constraint of certain development milestones and the remaining risks associated with the development required to achieve the milestones. The Company determined that the consideration for CMC activities represents variable consideration. CMC activities for one of the three designated targets have been initiated. The Company has elected to apply the Right to Invoice practical expedient under ASC 606 related to the CMC activities. As such, the Company will recognize revenue related to the CMC activities when the services are performed over the corresponding CMC plan for a given target. Consistent with the allocation objective under ASC 606, the Company allocated the total transaction price to the Johnson & Johnson Licenses and research activities and first substitution right based on each performance obligation’s relative standalone selling price. Each of the standalone selling prices for the Johnson & Johnson Licenses and research activities and for the first substitution right were estimated utilizing an income approach, along with the likelihood of exercise for the substitution right and included the following key assumptions: the development timeline, revenue forecast, discount rate and probabilities of technical and regulatory success. Due to Johnson & Johnson's exercise of its first substitution right, the transaction price related to that performance obligation has been reallocated to the Johnson & Johnson Licenses and research activities for the three designated targets. The Company is recognizing revenue related to the Johnson & Johnson Licenses and research services performance obligation over the estimated period of the research services using a proportional performance model. The Company measures proportional performance based on the costs incurred relative to the total costs expected to be incurred. During the years ended December 31, 2023 and 2022, the Company recorded collaboration revenue of $16.6 million and $24.2 million, respectively, related to its performance obligations under the Johnson & Johnson Agreement. As of December 31, 2023 and 2022, the Company had recorded $10.4 million and $15.8 million, respectively, in deferred revenue related to the Johnson & Johnson Agreement that will be recognized over the remaining performance period and classified as current or noncurrent on the consolidated balance sheets based upon the expected timing of satisfaction of respective performance obligations. Merck KGaA Immunosynthen Platform Agreement In December 2022, the Company entered into a research collaboration and license agreement with Ares Trading S.A., a wholly owned subsidiary of Merck KGaA, Darmstadt, Germany (Merck KGaA and/or its affiliate, as applicable, "Merck KGaA" and such agreement, the "2022 Merck KGaA Agreement"), focused on the research, development and commercialization of novel ADCs for up to two specific target antigens by leveraging Mersana’s ADC expertise and Immunosynthen platform with Merck KGaA’s proprietary antibodies. In connection with the 2022 Merck KGaA Agreement, the Company received a non-refundable upfront payment of $30.0 million. Pursuant to the 2022 Merck KGaA Agreement, the Company granted Merck KGaA two exclusive, non-transferable, worldwide licenses - a research license and a commercialization license (together, the "Merck KGaA Licenses"). The research license that forms a part of the Merck KGaA Licenses provides Merck KGaA, on a target-by-target basis, rights under the Company’s technology and the Company’s interest in the technology developed jointly through the collaboration solely to conduct Merck KGaA’s activities under the research and CMC plans with respect to each target. The commercialization license that forms a part of the Merck KGaA Licenses is a royalty-bearing license granted on a target-by-target basis under the Company’s technology and the Company’s interest in the technology developed jointly through the collaboration to develop, manufacture, commercialize and otherwise exploit licensed ADCs and any licensed products containing licensed ADCs directed toward a target. Pursuant to mutually agreed research and CMC plans, the Company agreed to perform bioconjugation, production development, preclinical manufacturing, and certain related research and preclinical development activities, in order to progress the targets through IND (or foreign equivalent) submission for further development, manufacture and commercialization by Merck KGaA. Merck KGaA will have sole responsibility for IND-enabling studies, IND submission, clinical development, regulatory activities and commercialization of the licensed ADCs. Both the Company and Merck KGaA will have equal representation on a Joint Research Committee and Joint Manufacturing Committee to oversee the research and CMC activities. The Company estimates that its activities under the research plans for the targets will be performed through 2026. The Company's CMC activities will be compensated by Merck KGaA at agreed upon rates. Assuming successful development and commercialization of the two targets by Merck KGaA, the Company is eligible to receive up to $200 million in development and regulatory milestones and $600 million in sales milestones as well as tiered single-digit to low double-digit royalties on aggregate net sales of the ADC products. Unless earlier terminated, the 2022 Merck KGaA Agreement will expire upon the expiration of the last royalty term for a product under the 2022 Merck KGaA Agreement. The 2022 Merck KGaA Agreement contains customary provisions for termination by either party, including in the event of breach of the 2022 Merck KGaA Agreement, subject to cure, by Merck KGaA for convenience and by the Company upon a challenge of the licensed patents, and customary provisions regarding the effects of termination. Merck KGaA may request that the Company perform clinical manufacturing services under a separate clinical supply agreement. Merck KGaA may also request that the Company perform a technology transfer of bioconjugation technology, at Merck KGaA's cost, at an agreed upon rate. Accounting Analysis The Company assessed the 2022 Merck KGaA Agreement in accordance with ASC 606 and concluded that the contract counter party, Merck KGaA, is a customer. The Company identified the following four material performance obligations under the 2022 Merck KGaA Agreement: (i) exclusive Merck KGaA Licenses and research activities for each of the two designated targets and (ii) CMC activities for each of the two designated targets. The Company concluded that the Merck KGaA Licenses and research activities are one combined performance obligation for each target as the Merck KGaA Licenses are not capable of being distinct from the research activities given their proprietary nature. The CMC activities are considered a distinct performance obligation for each target as the activities could be performed by a third-party provider. In accordance with ASC 606, the Company determined that the initial transaction price under the 2022 Merck KGaA Agreement equals $32.0 million, consisting of the $30.0 million upfront, non-refundable and non-creditable fee and certain near-term discovery milestones. The $30.0 million upfront fee was not received by the Company as of December 31, 2022, and was recorded as an accounts receivable with a corresponding deferred revenue liability for the year ended December 31, 2022. The Company subsequently received this payment in February 2023. The development and the regulatory milestones not included in the transaction price were constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including stage of development and the remaining risks associated with the development required to achieve the milestones, as well as whether the achievement of the milestones is outside the control of the Company or Merck KGaA. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as such milestones were determined to relate predominantly to the license granted to Merck KGaA and therefore have also been excluded from the transaction price. The Company determined that the consideration for CMC activities represents variable consideration. The Company has elected to apply the Right to Invoice practical expedient under ASC 606 related to the CMC activities. As such, the Company will recognize revenue related to the CMC activities when the services are performed over the corresponding CMC plan for a given target. CMC activities for the targets have not yet been initiated. Consistent with the allocation objective under ASC 606, the Company allocated the $32.0 million estimated transaction price to the Merck KGaA Licenses and research activities based on each performance obligation’s relative standalone selling price. Each of the standalone selling prices for the Merck KGaA Licenses and research activities were estimated utilizing an adjusted market assessment approach, which was established based on comparable transactions. The Company is recognizing revenue related to the Merck KGaA Licenses and research services performance obligation over the estimated period of the research services using a proportional performance model. The Company measures proportional performance based on the costs incurred relative to the total costs expected to be incurred. During the year ended December 31, 2023, the Company recorded collaboration revenue of $10.7 million related to its efforts under the 2022 Merck KGaA Agreement. The Company did not record collaboration revenue related to the 2022 Merck KGaA Agreement during the year ended December 31, 2022. As of December 31, 2023 and 2022, the Company had recorded $20.2 million and $30.0 million, respectively, in deferred revenue related to the unsatisfied performance obligations under the 2022 Merck KGaA Agreement. This deferred revenue will be recognized over the remaining performance period and classified as current or noncurrent on the consolidated balance sheets based upon the expected timing of satisfaction of respective performance obligations. Dolaflexin Platform Agreement In June 2014, the Company entered into a collaboration and commercial license agreement with Merck KGaA, Darmstadt Germany (as amended from time to time, the "2014 Merck KGaA Agreement"). The 2014 Merck KGaA Agreement provided Merck KGaA with the right to develop ADCs directed to six exclusive targets. In May 2018, the Company entered into a Supply Agreement with Merck KGaA, Darmstadt, Germany (as amended from time to time, the "2018 Merck KGaA Supply Agreement"). Under the terms of the 2018 Merck KGaA Supply Agreement, the Company could provide Merck KGaA preclinical non-good manufacturing practice ADC drug substance and clinical good manufacturing practice drug substance for use in clinical trials associated with one of the antibodies designated under the 2014 Merck KGaA Agreement. In the fourth quarter of 2023, the Company and Merck KGaA mutually agreed to terminate the 2014 Merck KGaA Agreement and the 2018 Merck KGaA Supply Agreement. Accounting Analysis The 2014 Merck KGaA Agreement and 2018 Merck KGaA Supply Agreement were terminated during the fourth quarter of 2023. As there are no further performance obligations, the Company recognized $3.7 million of revenue related to the termination of the 2014 Merck KGaA Agreement and the 2018 Merck KGaA Supply Agreement during the year ended December 31, 2023. Prior to the termination of the agreements, the Company had identified the following performance obligations under the 2014 Merck KGaA Agreement: (i) exclusive license and research services for six designated targets, (ii) rights to future technological improvements and (iii) participation of project team leaders and providing joint research committee services. The Company had concluded that each license for a designated target was not distinct from the research services performed related to the designated target as Merck KGaA could not obtain the benefit of the license without the related research services. Each license for a designated target and the related services performance obligation was considered distinct from every other license for a designated target and related services performance obligation as each research plan was pursued independent of every other research plan for other designated targets. Collaboration revenue recognized related to the 2014 Merck KGaA Agreement and the 2018 Merck KGaA Supply Agreement during the year ended December 31, 2023 was $3.7 million. Collaboration revenue recognized related to the 2014 Merck KGaA Agreement and the 2018 Merck KGaA Supply Agreement during the years ended December 31, 2022 and 2021 was immaterial. As of December 31, 2023, the Company did not have deferred revenue related to the 2014 Merck KGaA Agreement and 2018 Merck KGaA Supply Agreement. As of December 31, 2022, the Company had recorded $3.9 million in deferred revenue related to the 2014 Merck KGaA Agreement and 2018 Merck KGaA Supply Agreement, in the aggregate. Summary of Contract Assets and Liabilities The following table presents changes in the balances of the Company's contract liabilities: Balance at Beginning of Period Additions Deductions Balance at End of Period Year ended December 31, 2023 Contract liabilities: Total deferred revenue $ 147,653 $ 5,517 $ 27,856 $ 125,314 Year ended December 31, 2022 Contract liabilities: Total deferred revenue $ 3,944 $ 170,000 $ 26,291 $ 147,653 The Company did not record any contract assets associated with its collaboration agreements as of December 31, 2023 and December 31, 2022. During the years ended December 31, 2023 and 2022 the Company recognized the following revenues as a result of changes in the contract liability balances in the respective periods: Year ended December 31, 2023 2022 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ 27,870 $ 43 Other Revenue |