Collaboration agreements | 3. Collaboration agreements Takeda XMT-1522 strategic partnership In January 2016, the Company entered into a Development Collaboration and Commercial License Agreement with Takeda through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc. for the development and commercialization of XMT-1522 (the XMT-1522 Agreement). Under the XMT-1522 Agreement, Takeda was granted the exclusive right to commercialize XMT-1522 outside of the United States and Canada. Under the XMT-1522 Agreement, the Company is responsible for conducting certain Phase 1 development activities for XMT-1522, including the ongoing Phase 1 clinical study, at its own expense. Takeda has the option to conduct Phase 1 development activities at its own expense within its territory. The parties agreed to collaborate on the further development of XMT-1522 in accordance with a global development plan (Post-Phase 1 Development). The parties agreed to share equally all clinical stage manufacturing costs and any Post-Phase 1 Development costs incurred in the performance of activities for the purpose of obtaining regulatory approval in either the United States or Canada and in certain other major markets in the rest of the world. Each party will be responsible for all Post-Phase 1 Development costs incurred in the performance of activities solely for the purpose of obtaining regulatory approval in such party's territory. Each party may conduct independent development of XMT-1522, subject to certain restrictions. The Company received an upfront payment of $26,500 upon execution of the XMT-1522 Agreement. In addition, the Company was entitled to a milestone payment of $20,000 upon achievement of the IND Clearance Date (as defined therein). The Company achieved the IND Clearance Date in October 2016. In addition to the milestone payment upon achievement of the IND Clearance Date, the Company is entitled to receive future development, regulatory and commercial milestones of up to $288,000, consisting of $87,000 of development milestones, $128,000 of regulatory milestones and $73,000 of commercial milestones, as well as royalties in the low to mid teens on net sales of XMT-1522 in Takeda’s territory during the applicable royalty term. There are development milestones payable upon the achievement of nine separate events: the initiation of Phase 2 clinical trials and Phase 3 clinical trials for four separate specified patient populations and the initiation of a Phase 3 clinical trial for one additional unspecified patient population. There are 14 regulatory milestones, which are payable upon regulatory submissions, regulatory approvals and pricing approvals, as applicable, for the U.S., European Union and Japanese markets for up to four separate patient populations and multiple label indications. In addition, a regulatory milestone is payable upon the receipt of regulatory and pricing approval in two specified markets other than the United States, the European Union or Japan. There are three individual commercial milestones, which are payable upon the attainment of certain thresholds for annual net sales. The next potential milestone the Company will be eligible to receive is a development milestone of $12,000 related to the initiation of a Phase 2 clinical trial. The XMT-1522 Agreement expires upon the expiration of the royalty term for XMT-1522, after which time, Takeda will have a perpetual, royalty-free license. However, Takeda may terminate the XMT-1522 Agreement in its entirety for convenience upon 30 days' prior written notice at any time up to the initiation of the first Phase 2 clinical study of XMT-1522 or upon 90 days' prior written notice following the initiation of the first Phase 2 clinical study of XMT-1522. Each party may terminate the XMT-1522 Agreement in its entirety upon bankruptcy or similar proceedings of the other party and in its entirety or on a country-by-country basis upon an uncured material breach of the agreement by the other party. Following termination, XMT-1522 will revert to the Company for further development and commercialization. Takeda strategic research and development partnership In March 2014, the Company entered into a Research Collaboration and Commercial License Agreement with Takeda through Takeda’s wholly owned subsidiary, Millennium Pharmaceuticals, Inc. (the 2014 Agreement). The 2014 Agreement was amended in January 2015 and amended and restated in January 2016 (the 2016 Restated Agreement). The agreements initially provided Takeda with the right to develop ADCs directed to a total of seven exclusive targets, designated by Takeda, over a specified period of time. Takeda will be responsible for the product development and marketing of any products resulting from this collaboration. To date, the Company has received $24,800 in non-refundable upfront fees, technology access fees or option exercise fees. For the two targets initially under the 2014 Agreement, the Company initially granted a research license upon designation of a target. To receive a development and commercialization license for these designated targets, Takeda was required to pay an additional option exercise fee of $1,300. For the remaining five targets, the Company grants a research, development and commercialization license upon the designation of a target. For each designated target, the Company and Takeda develop research plans to evaluate Takeda's antibodies as ADCs incorporating the Company's technology. The Company receives service fees for its efforts under the research plans. The goal of the research plans is to provide Takeda with sufficient information to formally nominate a development candidate and begin Investigational New Drug Application (IND), enabling studies or cease development on the designated target. As of September 30, 2018, Takeda had designated four targets and received development and commercialization licenses for the first, third and fourth designated targets and a research license for the second designated target. Takeda has limited replacement rights for two designated targets, subject to certain contractual restrictions. Takeda is required to pay $500 to utilize the second limited replacement right. As of September 30, 2018, if products are successfully developed and commercialized, the Company would be entitled to receive aggregate milestones of up to $474,750 for all eligible designated targets consisting of $ 50,250 in development milestones, $153,000 in regulatory milestones, and $ 271,500 in commercial milestones. The total milestones payable on each of the remaining eligible three targets are $158,250. There are four individual development milestones per target, which are payable upon the filing of an IND application and the initiation of Phase 1 through Phase 3 clinical trials. There are eight individual regulatory milestones per target. These are payable upon regulatory submissions, regulatory approvals and pricing approvals, as applicable, for the U.S., European Union and Japanese markets and regulatory approvals for both a second and third indication. There are six individual commercial milestones, which are payable upon the first commercial sale in each of the U.S., European Union and Japanese markets and upon the attainment of three separate defined thresholds for annual net sales. The next potential milestone payment the Company will be eligible to receive is a development milestone of $750 related to the filing of an IND. The Company is also entitled to receive royalties on product sales, if any, during the applicable royalty term. Royalties payable on the remaining designated targets are in the mid to high single digits. The Company may elect to exercise an option to co-develop and co-commercialize one product incorporating either Takeda's fifth, sixth or seventh target in the United States for a payment of $15,000. If the Company elects to exercise the option to co-develop and co-commercialize a product, the Company will share in 50% of the profits related to the United States. The Company will be responsible for 50% of costs incurred specifically for the United States and 30% of global development costs. Any costs incurred specifically for a foreign country will be borne 100% by Takeda. If the Company elects to co-develop and co-commercialize a product, certain regulatory milestones and royalties related to the United States for that target would not be paid by Takeda. Unless earlier terminated, the 2016 Restated Agreement will expire upon the expiration of the last royalty term for a product under the agreement, after which time, Takeda will have a perpetual, royalty-free license. Except with respect to the target antigen of a product for which the Company exercised its option to co-develop and co-commercialize in the United States, Takeda may terminate the 2016 Restated Agreement in its entirety or with respect to any target for convenience upon 45 days' prior written notice. Each party may terminate the 2016 Restated Agreement in its entirety upon bankruptcy or similar proceedings of the other party or upon an uncured material breach of the agreement by the other party. However, if such breach only relates to one target, the agreement may only be terminated with respect to such target. Accounting Analysis For periods prior to January 1, 2018, the Company applied the provisions of ASC 605 in accounting for these arrangements. Refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 28, 2018 for the accounting analysis under these provisions. Under ASC 605 and Topic 606, the Company has concluded that the 2016 Restated Agreement and the XMT-1522 Agreement should be accounted for as one arrangement due in part because the agreements are with the same party and were negotiated and executed contemporaneously. Further, in applying the contract modification practical expedient, the Company has aggregated the effect of all modifications through the initial date of application of Topic 606 for the purposes of (i) identifying the satisfied and unsatisfied performance obligations, (ii) determining the transaction price and (iii) allocating the transaction price to the satisfied and unsatisfied performance obligations. The performance obligations and the allocated transaction price as of the date of initial application of Topic 606 are as follows: Allocated Performance obligations Transaction Price XMT-1522 license and research services $ 49,828 Joint research committee services for XMT-1522 449 Exclusive license to the first designated target and research services 6,611 Research license to the second designated target and research services 1,017 Material right related to the exclusive license to the second designated target 526 Exclusive license to the third designated target and research services 4,974 Exclusive license to the fourth designated target and research services 3,678 Material right related to the license to the fifth designated target and research services 3,506 Material right related to the license to the sixth designated target and research services 3,506 Material right to license to the seventh designated target and research services 3,506 Material right related to first replacement right for a designated target 3,506 Material right related to the second replacement right to a designated target 3,116 Rights to future technological improvements 1,750 Joint research committee services 150 $ 86,123 The Company has concluded the license related to each of the designated targets is not distinct from the research services performed related to each of the designated targets as Takeda cannot obtain the benefit of the license without the related research services. Each license to a designated target and the related services performance obligation is considered distinct from every other license to a designated target and related services performance obligation as each research plan is pursued independent of the any other research plans for other designated targets. Further, the material rights provided in the agreement provide Takeda incremental rights for either no additional consideration or for additional fees that contain a significant discount. The material rights are distinct from the other performance obligations in the arrangement as they are options in the contract and are not required for Takeda to obtain the benefit of the other promised goods or services in the arrangement. Similarly, the Company concluded that the XMT-1522 license and the related research and development services, including the Phase 1 development and the transfer certain materials and know how related to the Company's manufacturing processes are one performance obligation. The license to the Company's intellectual property is not distinct from the research and related development services that the Company is obligated to perform. Takeda would not have the ability to realize the value of the license without the Company performing the related services. The Company has concluded that the Post-Phase 1 Development activities under the XMT-1522 Agreement represent joint operating activities in which both parties are active participants and of which both parties are exposed to significant risks and rewards that are dependent on the commercial success of the activities. Accordingly, the Company is accounting for the Post-Phase 1 Development activities in accordance with ASC 808 and they are not considered revenue elements under Topic 606. For the three months ended September 30, 2018 and 2017 and the nine months ended September 30, 2018 and 2017, the Company was billed approximately $2,210, $924, $5,013 and $1,719, respectively, from Takeda representing the Company's share of Post-Phase 1 Development costs incurred by Takeda. These amounts have been reflected as research and development costs in the consolidated statement of operations. The Company did not perform any Post-Phase 1 Development activities or incur any associated costs prior to January 1, 2018. During the three months ended September 30, 2018 and 2017 and the nine months ended September 30, 2018 and 2017, the Company billed Takeda $ 1,165 , $0, $2,959 and $ 0 , respectively, related to ASC 808 costs. As of the date of initial application of Topic 606, the total transaction price for the 2016 Restated Agreement and the XMT-1522 Agreement was $86,123, which included approximately $14,023 of fees associated with research and development activities which had been or were expected to be provided. The Company utilizes the expected value approach to estimate the amount of consideration related to the fees associated with development and research services. The Company utilizes the most likely amount approach to estimate any development and regulatory milestone payments to be received. As of the date of initial application of Topic 606, there were no milestone payments, which had not been received, included in the estimated transaction price. The Company considered the stage of development and the remaining risks associated with the remaining development required to achieve the milestone, as well as whether the achievement of the milestone is outside the control of the Company or Takeda. The milestone payment amounts were fully constrained, as a result of the uncertainty whether any of the associated milestones would be achieved. The Company has determined that any commercial milestones and sales based royalties will be recognized when the related sales occur as they were determined to relate predominantly to the license granted and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The transaction price was allocated to the performance obligations based on the relative estimated standalone selling prices of each performance obligation or, in the case of certain variable consideration, to one or more performance obligations. The estimated standalone selling prices for performance obligations which include a license and research services, was developed using the estimated selling price of the license and an estimate of the overall effort to perform the research service and an estimated market rate for research services. The estimated standalone selling price of the licenses was established based on comparable transactions. The estimated standalone selling price for the material rights and rights to future technological improvements were developed based on the estimated selling prices of a license or rights received and any fees payable upon exercise of the associated option, as well as considering the probability that additional technology would be made available or the probability the counterpart would utilize the technology or exercise the option. The estimated standalone selling price for the joint research committee services was developed using an estimate of the time and costs incurred to participate in the committees. The Company will recognize revenue related to the performance obligations, which include research licenses or an exclusive development and commercialization license and the related research services, over the estimated period of the research and development services using a proportional performance model. The Company measures proportional performance based on the costs incurred relative to the total estimated costs of the research. To the extent that the Company receives fees for the research services as they are performed, these amounts are recorded as deferred revenue. Revenue related to material rights will be recognized when the option is exercised, unless there are additional research services that the Company is required to perform related to the designated target (in which case revenue will be recognized based on the proportional performance model) or at the time the option right lapses. To the extent that the Company receives a fee upon exercise of the option, such amounts are recorded as deferred revenue. Revenue related to the material rights related to replacement rights will be recognized over the research term of the replacement target once the replacement right is exercised or at the time the right lapses unused. To the extent that the Company receives a fee upon exercise of the replacement right, such amounts are recorded as deferred revenue. Revenue related to future technological improvements and joint research committee services will be recognized ratably over the performance period (which in the case of the joint research committee services approximates the time and cost incurred), which is expected to be ten years and six years, respectively. The Company will reassess the estimated remaining term at each subsequent reporting period. For the three months ended September 30, 2018 and 2017 and the nine months ended September 30, 2018 and 2017, the Company recorded total revenue of $82, $5,768, $ 4,697 and $12,052, respectively, related to its efforts under the 2016 Restated Agreement and the XMT-1522 Agreement. Included in accounts receivable as of September 30, 2018 and December 31, 2017 was $32 and $454, respectively, related to the Takeda agreements. Included in accounts payable as of September 30, 2018 was $530 related to the Takeda agreements. During the quarter ended September 30, 2018, the Company revised its estimate of the total costs to complete research services under the 2016 Restated Agreement and the XMT-1522 Agreement, which changed the total consideration to be received under the agreements and the amount of revenue recognized in the three months and nine months ended September 30, 2018. The Company recognized approximately $1,380 less for the three months and nine months ended September 30, 2018 as a result of the Company’s change in estimate. The change in estimate increased the net loss by $1,380 for the three months and nine months ended September 30, 2018, or $0.06 per common share. As of September 30, 2018, the Company had $41,104 of deferred revenue related to the Takeda agreements that will be recognized over the remaining performance periods for the applicable obligations. Takeda invested $10,000 as part of the Company’s IPO. Merck KGaA In June 2014, the Company entered into a Collaboration and Commercial License Agreement with Merck KGaA (the Merck KGaA Agreement). Upon the execution of the agreement, Merck KGaA paid the Company a nonrefundable technology access fee of $12,000 for the right to develop ADCs directed to six exclusive targets over a specified period of time. No additional fees are due when a target is designated and the commercial license to the target is granted. Merck KGaA will be responsible for the product development and marketing of any products resulting from this collaboration. All six targets were designated prior to 2018. Under the terms of the agreement, the Company and Merck KGaA develop research plans to evaluate Merck KGaA's antibodies as ADCs incorporating the Company's technology. The Company receives fees for its efforts under the research plans. The goal of the research plans is to provide Merck KGaA with sufficient information to formally nominate a development candidate and begin IND-enabling studies or cease development on the designated target. In addition to the payments received for research and development activities performed on behalf of Merck KGaA, the Company is also eligible to receive up to a total of $780,000 in future milestones related to all targets under the agreement, plus low to mid single digit royalties on the commercial sales of any resulting products during the applicable royalty term. The total milestones are categorized as follows: development milestones—$84,000; regulatory milestones—$264,000; and sales milestones—$432,000. There are six individual development milestones per target, payable upon the completion of various activities from the delivery of ADCs meeting defined specifications, through the dosing in a Phase 3 clinical trial. There are five regulatory milestones, which are payable upon regulatory approvals for a first indication in each of the U.S., European Union and Japanese markets and regulatory approvals for both a second and a third indication in the United States. There are three individual commercial milestones, which are payable upon the attainment of certain defined thresholds for annual net sales. Prior to 2018, the Company had received $3,000 related to development milestones under the agreement. There have been no additional milestone payments in the nine months ended September 30, 2018. The next potential milestone payment the Company will be eligible to receive will be a development milestone of $500 on Merck KGaA's designation of a preclinical development candidate for any target. Revenue will be recognized upon achievement of the milestone. The Company and Merck KGaA may also enter into a future supply agreement to provide clinical study material should Merck KGaA pursue clinical development of any candidates nominated under the agreement. Unless earlier terminated, the agreement will expire upon the expiration of the last royalty term for a product under the agreement, after which time, Merck KGaA will have a perpetual, royalty-free license, or if Merck KGaA does not designate any ADC product candidates produced by the Company under the agreement as preclinical development candidates, upon the expiration of the last to expire research program. Merck KGaA may terminate the agreement in its entirety or with respect to any target for convenience upon 60 days' prior written notice. Each party may terminate the Merck KGaA Agreement in its entirety upon bankruptcy or similar proceedings of the other party or upon an uncured material breach of the agreement by the other party. However, if such breach only relates to one target, the agreement may only be terminated with respect to such target. In May 2018, the Company entered into a Supply Agreement with Merck KGaA (the Merck KGaA Supply Agreement). Under the terms of the agreement, the Company will provide Merck KGaA preclinical non-GMP ADC Drug Substance and clinical GMP Drug Substance for use in clinical trials associated with one of the antibodies designated under the Merck KGaA Agreement. The Company receives fees for its efforts under the Merck KGaA Supply Agreement and reimbursement equal to the supply cost. Accounting Analysis For periods prior to January 1, 2018, the Company applied the provisions of ASC 605 in accounting for this arrangement. Refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 28, 2018 for the accounting analysis under these provisions. By applying the contract modification practical expedient, the Company has aggregated the effect of all modifications through the initial date of application of Topic 606 for the purposes of (i) identifying the satisfied and unsatisfied performance obligations, (ii) determining the transaction price and (iii) allocating the transaction price to the satisfied and unsatisfied performance obligations. The Company identified the following performance obligations under the 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 has concluded that each license for a designated target is not distinct from the research services performed related to the designated target as Merck KGaA cannot obtain the benefit of the license without the related research services. Each license for a designated target and the related services performance obligation is considered distinct from every other license for a designated target and related services performance obligation as each research plan is pursued independent of every other research plans for other designated targets. As of the date of initial application of Topic 606, the total transaction price for the Merck KGaA Agreement was $22,875, which included approximately $7,875 fees for research and development activities which have been or were expected to be received and $3,000 of milestone payments previously earned. The Company utilizes the expected value approach to estimate the amount of consideration related to the payment of fees associated with development and research services. The Company utilizes the most likely amount approach to estimate any development and regulatory milestone payments to be received. As of the date of initial application of Topic 606, there were no milestones payments that had not already been received, included in the estimated transaction price. The Company considered the stage of development and the remaining risks associated with the remaining development required to achieve the milestone, as well as whether the achievement of the milestone is outside the control of the Company or Merck KGaA. The milestone payment amounts were fully constrained, as a result of the uncertainty whether any of the associated milestones would be achieved. The Company has determined that any commercial milestones and sales based royalties will be recognized when the related sales occur as they were determined to relate predominantly to the license granted and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. For each of the three and nine months ended September 30, 2018, the transaction price decreased $805 to $22,070 due to a decrease in fees for research and development activities expected to be received, as the Company revised its estimate for fees associated with research and development activities under the Merck KGaA Agreement in the third quarter of 2018 to $7,070. The revised total transaction price for the Merck KGaA Agreement is $22,070. The transaction price was allocated to the performance obligations based on the relative estimated standalone selling prices of each performance obligation or in the case of certain variable consideration to one or more performance obligations. The estimated standalone selling prices for performance obligations, that include a license and research services, were developed using the estimated selling price of the license and an estimate of the overall effort to perform the research service and an estimated market rate for research services. The estimated standalone selling price of the licenses was established based on comparable transactions. The estimated standalone selling price for the rights to future technological improvements was developed based on the estimated selling prices of a license or rights received, as well as considering the probability that additional technology would be made available or the probability the counterpart would utilize the technology. The estimated standalone selling price for the joint research committee services was developed using an estimate of the time and costs incurred to participate in the committees. The transaction price of $22,875 was allocated to the performance obligations as follows: approximately $4,226 for each of the license and corresponding research and development services units of account for the first and second designated targets; $3,439 for each of the license and corresponding research and development services units of account for the third, fourth, fifth and sixth designated target; $425 for rights to future technological improvements; and $242 for joint research committee services. The Company is recognizing revenue related to the exclusive license and research and development services performance obligation over the estimated period of the research and development 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. To the extent that the Company receives fees for the research services as they are preformed, these amounts are recorded as deferred revenue. Revenue related to future technological improvements and joint research committee services will be recognized ratably over the performance period (which in the case of the joint research committee services approximate the time and cost incurred each period), which are 10 and 5 years, respectively. The Company is continuing to reassess the estimated remaining term at each subsequent reporting period. During the three months ended September 30, 2018 and 2017 and the nine months ended September 30, 2018 and 2017, the Company recorded revenue of $1,482, $499, $2,426 and $2,107, respectively, related to its efforts under the collaboration agreement. Included in accounts receivable as of September 30, 2018 and December 31, 2017 was $163 and $330, respectively, related to the Merck KGaA Agreement. As of September 30, 2018, the Company had recorded $ 5,480 in deferred revenue related to the Merck KGaA Agreement that will be recognized over the remaining performance period. Summary of Contract Assets and Liabilities The following table presents changes in the balances of our contract assets and liabilities during the three and nine months ended September 30, 2018: Balance at Beginning Balance at of Period Additions Deductions End of Period Three months ended September 30, 2018 Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 48,208 $ 849 $ 2,151 $ 46,906 Balance at Beginning Balance at of Period Additions Deductions End of Period Nine months ended September 30, 2018 Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 52,439 $ 2,373 $ 7,906 $ 46,906 The impact of the adoption of the new revenue recognition guidance is reflected within the beginning of period balance. During the three months and nine months ended September 30, 2018, the Company recognized the following revenues as a result of changes in the contract asset and the contract liability balances in the respective periods: Three months ended Nine months ended September 30, 2018 September 30, 2018 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ 1,760 $ 7,515 Performance obligations satisfied in previous periods $ — $ — Other Revenue The Company has provided limited services for a collaboration partner, Asana BioSciences. For the three months ended September 30, 2018 and 2017 and the nine months ended September 30, 2018 and 2017, the Comp |