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Collaboration and License Agreements and Supply Agreements | 3 Months Ended
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Mar. 31, 2023
Collaboration And License Agreements And Supply Agreements [Abstract] |
Collaboration and License Agreements and Supply Agreements | 5. Collaboration and License Agreements and Supply Agreements The Company has entered into collaboration and license agreements and supply agreements with various pharmaceutical and biotechnology companies. See “Note 5. Collaboration and License Agreements and Supply Agreements” to the Company’s financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2022, or as further described below, for additional information on each of its collaboration agreements. The Company’s accounts receivable balances may contain billed and unbilled amounts from milestones and other contingent payments, as well as reimbursable costs from collaboration and license agreements and supply agreements. The Company performs a regular review of its customers’ credit risk and payment histories, including payments made after the period end. Historically, the Company has not experienced credit loss from its accounts receivable and, therefore, has no t recorded a reserve for estimated credit losses as of March 31, 2023 and December 31, 2022. In accordance with the collaboration agreements, the Company recognized revenue as follows:
|  | Three Months Ended |
|  | March 31, |
|  | 2023 |  |  | 2022 |
|  | (in thousands) |
Bristol Myers Squibb Company (“BMS”) |  | $ | 3,166 |  |  | $ | 2,165 |
Merck Sharp & Dohme Corporation (“Merck”) |  |  | 2,553 |  |  |  | 1,064 |
Merck KGaA, Darmstadt, Germany (operating in the United States and Canada under the name “EMD Serono”) |  |  | 8 |  |  |  | 1,897 |
Astellas Pharma Inc. (“Astellas”) |  |  | 6,272 |  |  |  | - |
Vaxcyte |  |  | 675 |  |  |  | 771 |
Total revenue |  | $ | 12,674 |  |  | $ | 5,897 |
The following table presents the changes in the Company’s deferred revenue balance from collaboration agreements during the three months ended March 31, 2023:
|  | Three Months Ended |
|  | March 31, 2023 |
|  | (in thousands) |
Deferred revenue—December 31, 2022 |  | $ | 106,644 |
Additions to deferred revenue |  |  | 1,018 |
Recognition of revenue in current period |  |  | (5,430 | )
Deferred revenue—March 31, 2023 |  | $ | 102,232 |
The Company’s balance of deferred revenue contains an upfront payment and an advance payment for an obligation from one of our supply agreements which remains partially unsatisfied. The Company expects to recognize approximately $17.2 million of the deferred revenue over the next twelve months. Collaboration with BMS BMS Agreement In September 2014, the Company signed a Collaboration and License Agreement (the “BMS Agreement”) with BMS to discover and develop bispecific antibodies and/or antibody-drug conjugates (“ADCs”), focused primarily on the field of immuno-oncology, using the Company’s proprietary integrated cell-free protein synthesis platform, XpressCF®. In August 2017, the Company entered into an amended and restated collaboration and license agreement with BMS to refocus the collaboration on four programs that were advancing through preclinical development, including an ADC program targeting B cell maturation antigen (“BCMA ADC”). In May 2019, the U.S. Food and Drug Administration cleared the investigational new drug (“IND”) application for the BCMA ADC, which was discovered and manufactured by the Company and is the first collaboration program IND. BMS has worldwide development and commercialization rights with respect to the BCMA ADC. The Company will continue to be responsible for clinical supply manufacturing and certain development services for the BCMA ADC and is eligible to receive from BMS aggregate development and regulatory contingent payments of up to $275.0 million, if approved in multiple indications, and tiered royalties ranging from mid to high single digit percentages on worldwide sales of any resulting commercial products. As of both March 31, 2023 and December 31, 2022, there was no deferred revenue related to payments received by the Company under the BMS Agreement. 2018 BMS Master Services Agreement In March 2018, the Company entered into a Master Development and Clinical Manufacturing Services Agreement (the “2018 BMS Master Services Agreement”) with BMS, wherein BMS requested the Company to provide development, manufacturing and supply chain management services, including clinical product supply. As of March 31, 2023 and December 31, 2022, there was $1.2 million and $3.1 million, respectively, of deferred revenue under the 2018 BMS Master Services Agreement. Revenues under the BMS Agreement and the 2018 BMS Master Services Agreement were as follows:
|  | Three Months Ended |
|  | March 31, |
|  | 2023 |  |  | 2022 |
|  | (in thousands) |
Research and development services |  | $ | 221 |  |  | $ | 244 |
Materials supply |  |  | 2,945 |  |  |  | 1,921 |
Total revenue |  | $ | 3,166 |  |  | $ | 2,165 |
Collaboration with Merck 2018 Merck Agreement In July 2018, the Company e ntered into an agreement (the “2018 Merck Agreement”) with Merck for access to the Company’s technology and the identification and preclinical research and development of two target programs, with an option for Merck to engage the Company to continue these activities for a third program, upon the payment of an additional amount, focusing on cytokine derivatives for cancer and autoimmune disorders, with an initial transaction price of $60.0 million. The option to expand activities to a third program expired in January 2021. In March 2020, Merck exercised its option to extend the research term of the collaboration’s first cytokine-derivative program by one year, which, pursuant to the terms of the 2018 Merck Agreement, triggered a payment of $5.0 million. In April 2021, the Company earned a $15.0 million contingent payment for the initiation by Merck of the first IND-enabling toxicology study under the first cytokine-derivative program in the collaboration. In September 2021, the Company entered into an amendment to the 2018 Merck Agreement (the “2021 Amendment”) to extend the research term for the first program in the 2018 Merck Agreement. Under the terms of the 2021 Amendment, the Company received a payment of $2.5 million with an additional $7.5 million to be received upon the achievement of certain developmental milestones by Merck on a second molecule under the first cytokine-derivative program of the collaboration. Merck decided not to pursue further development of a second molecule under the first cytokine-derivative program of the collaboration and therefore allowed the option to extend the period for nomination of additional clinical candidates under the 2021 Amendment to expire in June 2022. In December 2021, Merck did not extend the research term for the second research program of the collaboration, which research program reverted to the Company. The first research program of the collaboration is focuse d on one distinct cytokine derivative molecule for the treatment of cancer. The Company is eligible to receive aggregate contingent payments of up to approximately $0.5 billion for the target program selected by Merck, assuming the develo pment and sale of the therapeutic candidate and all possible indications identified under the collaboration. If one or more products from the target program is developed for non-oncology or a single indication, the Company will be eligible for reduced aggregate contingent payments. In addition, the Company is eligible to receive tiered royalties ranging from mid-single digit to low teen percentages on the worldwide sales of any commercial products that may result from the collaboration. In July 2022, the first patient was dosed in a Phase 1 study of an investigational candidate resulting from the 2018 Merck Agreement for the development of a novel cytokine derivative therapeutic for the treatment of cancer. As a result of this achievement, the Company earned and received a $10.0 million contingent payment from Merck during the year ended December 31, 2022. As of both March 31, 2023 and December 31, 2022, there was no deferred revenue related to the 2018 Merck Agreement and 2021 Amendment. 2020 Merck Master Services Agreement In August 2020, the Company entered into a Pre-Clinical and Clinical Supply Agreement (the “2020 Merck Master Services Agreement”) with Merck, wherein Merck requested the Company to provide development, manufacturing and supply chain management services, including clinical product supply, upon completion of the research programs under the 2018 Merck Agreement. As of both March 31, 2023 and December 31, 2022, there was no deferred revenue under the 2020 Merck Master Services Agreement. Revenues under the 2018 Merck Agreement and the 2020 Merck Master Services Agreement were as follows:
|  | Three Months Ended |
|  | March 31, |
|  | 2023 |  |  | 2022 |
|  | (in thousands) |
Ongoing performance related to unsatisfied performance obligations |  | $ | - |  |  | $ | 862 |
Research and development services |  |  | 125 |  |  |  | 173 |
Materials supply |  |  | 2,428 |  |  |  | 29 |
Total revenue |  | $ | 2,553 |  |  | $ | 1,064 |
Collaboration with EMD Serono MDA Agreement and 2019 EMD Serono Supply Agreement The Company signed a Collaboration Agreement and a License Agreement with EMD Serono in May 2014 and September 2014, respectively, which were entered into in contemplation of each other and therefore treated as a single agreement for accounting purposes. The Collaboration Agreement was subsumed into the License Agreement (the “MDA Agreement”), which agreement is to develop ADCs for multiple cancer targets. In April 2019, the Company entered into an ADC Product Preclinical and Phase I Clinical Supply Agreement (the “2019 EMD Serono Supply Agreement”) with EMD Serono, wherein EMD Serono requested the Company to provide development, manufacturing and supply chain management services, including clinical product supply. In March 2023, EMD Serono disclosed its decision to close the Phase 1a trial of M1231 in patients with solid tumors and not initiate a previously planned expansion study. EMD Serono stated that the decision was based on strategic portfolio considerations. As of both March 31, 2023 and December 31, 2022, there was no deferred revenue related to payments received by the Company under the MDA Agreement or the 2019 EMD Serono Supply Agreement. Revenues under the EMD Serono agreements were as follows:
|  | Three Months Ended |
|  | March 31, |
|  | 2023 |  |  | 2022 |
|  | (in thousands) |
Research and development services |  | $ | 6 |  |  | $ | 284 |
Materials supply |  |  | 2 |  |  |  | 1,613 |
Total revenue |  | $ | 8 |  |  | $ | 1,897 |
Astellas License and Collaboration Agreement In June 2022, the Company entered into a License and Collaboration Agreement (the “Astellas Agreement”) with Astellas for the development of immunost imulatory antibody-drug conjugates for up to three biological targets, to be identified by Astellas. The Company will conduct research and pre-clinical development of any compound (as designated by Astellas) in each of the three programs in accor dance with the terms of a research plan between the Company and Astellas. Astellas will have an exclusive worldwide license to develop and commercialize any such designated compound, subject to the Company’s rights to participate in cost and profit sharing in the United States, as described below. Pursuant to the Astellas Agreement, the Company received from Astellas a one-time, nonrefundable, non-creditable, upfront payment of $90.0 million during the year ended December 31, 2022. Under ASC 808 and ASC 606, the Company determined that both parties are active participants in the activities and are exposed to significant risks and rewards dependent on the success of the development program, and identified four performance obligations under the Astellas Agreement as: (1) performance of services related to the first target program; (2) performance of services related to the second target program; (3) performance of services related to the third target program; and (4) the Company’s estimated future services on the collaboration JSC. The transaction price of $90.0 million was allocated among the performance obligations using the Company’s best estimate of the standalone selling price, or SSP, for each of the associated performance obligations. Revenue allocated to the three target programs, which totaled $89.1 million, is being recognized on a proportion of performance basis, using FTE cost as the basis of measurement, with such performance expected to occur over an estimated service period of four years for each target program. As it pertains to the JSC performance obligation, the revenue allocated to such performance obligation was $0.9 million, and is being recognized on a proportion of performance basis using FTE cost as the basis of measurement, and such effort is expected to be incurred on a relatively consistent basis throughout the term of the Astellas Agreement. Additionally, under ASC 606, the Company determined a financing component associated with the $90.0 million upfront payment and has calculated $32.6 million as of March 31, 2023, on the unearned revenue portion beyond one year from the effective date of the agreement, which amount is being recognized as interest expense and revenue over the estimated service period for the three target programs. The Company is also eligible to receive up to $422.5 million in develo pment, regulatory and commercial milestones for each product candidate, and tiered royalties ranging from low double-digit to mid-teen percentages on worldwide sales of any commercial products that may result from the collaboration, subject to customary deductions under certain circumstances. The Company can also elect to convert any product candidate into a cost and profit-sharing arrangement, for the United States only. In the event the Company makes such election, it will share commercialization costs and profits relating to such product candidate equally with Astellas in the United States, and no royalties will be due from Astellas for net sales of such product candidates in the United States. Revenues under the Astellas Agreement were as follows:
|  | Three Months Ended |
|  | March 31, |
|  | 2023 |  |  | 2022 |
|  | (in thousands) |
Ongoing performance related to unsatisfied performance obligations |  | $ | 2,572 |  |  | $ | - |
Research and development services |  |  | 1,157 |  |  |  | - |
Financing component on unearned revenue |  |  | 2,543 |  |  |  | - |
Total revenue |  | $ | 6,272 |  |  | $ | - |
As of March 31, 2023 and December 31, 2022, there was $83.5 million and $86.1 million of deferred revenue, respectively, related to the upfront payment received by the Company under the Astellas Agreement. Agreements with Vaxcyte Vaxcyte Supply Agreement In May 2018, the Company entered into a Supply Agreement (the “Supply Agreement”) with Vaxcyte, wherein Vaxcyte engaged the Company to provide research and development services and to supply extracts and custom reagents, as requested by Vaxcyte. The pricing is based on an agreed upon cost-plus arrangement. During 2020, upon Vaxcyte’s request and their agreement to reimburse the related costs, the Company entered into agreements with third-party contract manufacturing organizations, or CMOs, to conduct process transfers to allow for such CMOs to manufacture and supply extract and custom reagents for Vaxcyte. As part of the agreement with Vaxcyte, should the Company decide to purchase extract from the extract CMO, the Company would be required to reimburse Vaxcyte for a portion of all incurred process transfer costs. As of March 31, 2023 and December 31, 2022, there was $5.3 million and $4.8 million, respectively, in such accruals related to the Vaxcyte Supply Agreement. For the three months ended March 31, 2023 and 2022, the agreed-upon reimbursements by Vaxcyte of the costs associated with such arrangements, principally for pass-through costs from the CMOs, were $1.9 million and $2.4 million, respectively, and were accounted for by the Company as a reduction to research and development expense based on the Company’s conclusion that Vaxcyte was not a customer for such activities and associated payments. Revenues under the Vaxcyte Supply Agreement were as follows:
|  | Three Months Ended |
|  | March 31, |
|  | 2023 |  |  | 2022 |
|  | (in thousands) |
Research and development services |  | $ | 504 |  |  | $ | 601 |
Materials supply |  |  | 171 |  |  |  | 170 |
Total revenue |  | $ | 675 |  |  | $ | 771 |
Vaxcyte Agreement In December 2022, the Company entered into a letter agreement (the “Vaxcyte Agreement”) with Vaxcyte under which the Company granted to Vaxcyte (i) authorization to enter into an agreement with an independent alternate CMO to source cell-free extract solely for the products it licensed from the Company, allowing Vaxcyte to have direct oversight over financial and operational aspects of the relationship with the CMO (“CMO Relationship Rights”), and (ii) a right, but not an obligation, to obtain certain exclusive rights to internally manufacture and/or source extract from certain CMOs and the right to independently develop and make improvements to extract for use in connection with the exploitation of certain vaccine compositions (the “Option”). The Option is exercisable for five years following the effective date of the Vaxcyte Agreement (the “Option Period”), subject to potential acceleration in the event of a change of control of Vaxcyte. Pursuant to the Vaxcyte Agreement, the Company received a one-time, nonrefundable, non-creditable, upfront payment of $10.0 million in cash, and 167,780 shares of Vaxcyte common stock with a fair value of $7.5 million in December 2022. The Company will receive an additional nonrefundable, non-creditable payment of $5.0 million after the Company and Vaxcyte mutually agree in writing upon the Form Definitive Agreement that will become effective upon Vaxcyte’s exercise of the Option. In the event Vaxcyte elects to exercise the Option, Vaxcyte will pay the Company $75.0 million in cash in two installments, and upon the occurrence of certain regulatory milestones, certain additional payments totaling up to $60.0 million. In the event that Vaxcyte undergoes a change of control, and subsequently exercises the Option, a substantial majority of the milestone payments will be accelerated. The Company evaluated the terms of the Vaxcyte Agreement and concluded that the Vaxcyte Agreement is considered a new standalone contract and distinct from the previously existing agreements with Vaxcyte. Under ASC 606, the Company determined that Vaxcyte is a customer for this arrangement and identified the promised goods and services under the Vaxcyte Agreement as: (1) the Option; (2) the Form Definitive Agreement; (3) CMO Relationship Rights; and (4) Joint steering committee participation. The Company concluded that the promises within the contract are interrelated and interdependent of one another. As such, these are not considered distinct but are combined as a single performance obligation. This single performance obligation is considered a material right as it provides Vaxcyte with the right to acquire additional goods at a price it would not have received without having entered into the Vaxcyte Agreement. Other than the upfront cash and stock payments received, all other payment provisions in the Vaxcyte Agreement were considered constrained variable consideration or otherwise not eligible for revenue recognition at inception and as of March 31, 2023. Revenue for the single performance obligation was deferred and will be eligible to begin to be recognized at the earlier of when the Option is exercised or expires. As of each of March 31, 2023 and December 31, 2022, there was $17.5 million of deferred revenue, related to the upfront cash and stock payments received by the Company under the Vaxcyte Agreement.

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