License and Collaboration Arrangements | 5. License and Collaboration Arrangements The following tables present changes during the nine months ended September 30, 2020 in the balances of our contract assets, including receivables from collaboration partners, and contract liabilities, including deferred revenue (in thousands): Contract Assets Balance at December 31, 2019 $ 4,097 Additions 3,747 Deductions (6,361 ) Balance at September 30, 2020 $ 1,483 Contract Liabilities Balance at December 31, 2019 $ 6,409 Additions for advance billings 1,362 Deductions for performance obligations satisfied in current period (4,221 ) Deductions for updates to the measure of progress and decrease in transaction price from prior periods (2,299 ) Balance at September 30, 2020 $ 1,251 Bristol-Myers Squibb Company Immuno-Oncology Research Collaboration In March 2014, we entered into a research collaboration and license agreement, or the immuno-oncology research collaboration, with Bristol-Myers Squibb Company, or BMS. We identified one performance obligation under the immuno-oncology research collaboration for the research license to access our technology, the exclusive commercial license and research activities. BMS’s option to select additional collaboration targets is not priced at a discount and therefore does not represent one or more performance obligations for which the transaction price would be allocated. The transaction price of $36.1 million includes the $20.0 million non-refundable upfront fee, $13.7 million of research funding and $2.4 million of equity premium. as uncertain events are resolved and other changes in circumstances occur For the three and nine months ended September 30, 2020, no adjustments were made to the transaction price. Under the input method, we recognize revenue on the basis of our efforts or inputs applicable to the satisfaction of a performance obligation (e.g., resources consumed, labor hours expended, costs incurred, or time elapsed) relative to the total expected inputs applicable to the satisfaction of that performance obligation. We concluded that we will recognize revenue based on actual costs incurred as a percentage of total budgeted costs as we complete our performance obligation. As the performance obligation was fully satisfied through March 31, 2019, the transaction price of $36.1 million was fully recognized as collaboration revenue. Revenue recognized from the performance obligation was $0 for each of the three months ended September 30, 2020 and 2019, and $0 and $1.4 million for the nine months ended September 30, 2020 and 2019, respectively. L icense and Collaboration Agreement On October 14, 2015, we entered into a license and collaboration agreement, or the cabiralizumab collaboration agreement, with BMS. The cabiralizumab collaboration agreement supersedes the clinical trial collaboration agreement we entered into with BMS in November 2014, or the original collaboration agreement. We assessed the two agreements separately as standalone agreements under Topic 606. Under the original collaboration agreement, we identified one performance obligation for the execution of a Phase 1a/1b clinical trial of cabiralizumab in combination with Opdivo ® We used the input method to measure progress toward completion of the performance obligation and concluded that we will recognize revenue based on actual costs incurred by our clinical research organization, or CRO, as a percentage of total budgeted costs as we complete our performance obligation. We will recognize revenue from reimbursements when we have the right to invoice BMS. As the performance obligation was fully satisfied through June 30, 2020, the transaction price of $30.0 million was fully recognized as collaboration revenue. We recognized $0 and $0.9 million of the transaction price as revenue for the three months ended September 30, 2020 and 2019, respectively, and $0.8 million and $3.8 million for the nine months ended September 30, 2020 and 2019, respectively. Total revenue recognized for reimbursements for the three months ended September 30, 2020 and 2019 was $0 and $0.7 million, respectively, and for the nine months ended September 30, 2020 and 2019 was $1.7 million and $3.1 million, respectively. Under the cabiralizumab collaboration agreement, we identified the following performance obligations: (1) the license grant to BMS and (2) the transfer of licensed know-how to BMS. The transaction price consisted of the $350.0 million non-refundable up-front fee. As t was fully recognized as revenue concurrent with the transfer of the license and know-how in prior years We concluded that the transaction price should not yet include milestone payments that may become due, as they are fully constrained. We will recognize any consideration related to royalties when the related sales occur, as we have determined that these amounts relate predominantly to the license granted and therefore will be recognized upon the occurrence of the related sales. We will re-evaluate the transaction price in each reporting period as uncertain events are resolved and other changes in circumstances occur. For the three and nine months ended September 30, 2020, no adjustments were made to the transaction price. Zai Lab (Shanghai) Co., Ltd. In December 2017, we entered into a license and collaboration agreement, or the China collaboration agreement, with Zai Lab (Shanghai) Co., Ltd., or Zai Lab, pursuant to which we granted Zai Lab an exclusive license to develop and commercialize bemarituzumab in China, Hong Kong, Macau and Taiwan. We are currently dosing patients in a global double-blind Phase 2 clinical trial of bemarituzumab in combination with mFOLFOX6 as front-line treatment of patients with advanced FGFR2b+/HER2- gastric or GEJ cancer, which we refer to as our FIGHT trial . We identified the following performance obligations under the China collaboration agreement: (1) the license grant to Zai Lab together with the transfer of licensed know-how, development drug supply and global development activities, or the license grant, and (2) the development of companion diagnostics. Zai Lab has the option to purchase commercial drug supply from us pursuant to a separate commercial supply agreement to be negotiated in the future. The commercial drug supply will be accounted for as a separate contract when Zai Lab exercises this option. The transaction price of $9.6 million consists of the $3.7 million of expected reimbursement from Zai Lab for global development activities, $4.2 million non-refundable upfront fee and $1.7 million clinical development milestone payment. We have not included the regulatory milestone payments in the transaction price, as all such milestone amounts are fully constrained. We will recognize any consideration related to royalties when the related sales occur, as we determined that these amounts relate predominantly to the license granted and therefore will be recognized upon the occurrence of the related sales. We concluded that the reimbursement of costs incurred for the development of companion diagnostics qualifies for t We will re-evaluate the transaction price in each reporting period as uncertain events are resolved and other changes in circumstances occur. During the three and nine months ended September 30, 2020, the transaction price increased to $9.6 million from $8.9 million and was reduced to $9.6 million from $14.7 million, respectively, primarily as a result of our decision to amend We use the input method to measure progress toward completion of the performance obligation for the license grant. We concluded that revenue will be recognized based on actual costs incurred by our CRO as a percentage of total budgeted costs as we complete our performance obligation. We will recognize revenue from reimbursements for the development of companion diagnostics when we have the right to invoice Zai Lab. Revenue recognized for the license grant performance obligation was $1.9 million and $0.4 million for the three months ended September 30, 2020 and 2019, respectively, and $5.2 million and $1.0 million for the nine months ended September 30, 2020 and 2019, respectively. Total revenue recognized for the companion diagnostics development performance obligation was $0.2 million and $1.0 million for the three months ended September 30, 2020 and 2019, respectively, and $1.1 million and $2.4 million for the nine months ended September 30, 2020 and 2019, respectively. Of the remaining transaction price of $1.3 million, we recorded $0.6 million in deferred revenue, which we will recognize over the estimated performance period for satisfaction of the performance obligations. The remaining $0.7 million of the transaction price will be recorded in deferred revenue when invoiced as we complete global development activities. Seagen Inc. In February 2020, we entered into a global license agreement, or the Seagen license agreement, with Seagen Inc., or Seagen, pursuant to which we granted Seagen an exclusive worldwide license to a family of monoclonal antibodies that are directed to a single target and Seagen is responsible for research, development, manufacturing and commercialization of novel antibody-drug conjugate products based on these antibodies. Pursuant to the Seagen license agreement, Seagen paid us an upfront fee of $5.0 million. Additionally, we are eligible to receive up to (i) $132.0 million in specified developmental and regulatory milestone payments for the first achievement of such milestone events by the first licensed product, (ii) $68.0 million in specified developmental and regulatory milestone payments for the first achievement of such milestone events by the second licensed product, and (iii) $19.0 million in specified developmental and regulatory milestone payments for each achievement of such milestone events by a subsequent licensed product. We are also eligible to receive up to $162.5 million in sales-based contingent payments per licensed product. Seagen will also be obligated pay us an additional mid-single-digit percentage royalty on net sales of each licensed product in a region until the latest of: (i) 11 years after the first commercial sale of such licensed product in such region; (ii) the expiration of certain patents covering such licensed product in such region; and (iii) the date on which any applicable regulatory exclusivities with respect to such licensed product expire in such region. We are also eligible to receive annual maintenance fees of $0.2 million. Unless earlier terminated by either party, the Seagen agreement will expire on a licensed product-by-licensed product and country-by-country basis upon the expiration of Seagen’s royalty term with respect to each licensed product in the applicable country under the agreement. Seagen may terminate the agreement in its entirety at any time with advance written notice. Either party may terminate the agreement in its entirety with written notice for the other party’s material breach if such other party fails to cure the breach. . We may terminate the agreement in its entirety if Seagen or its affiliates or sublicensees commences a legal action challenging the validity, enforceability or scope of any of our patents. Either party also may terminate the agreement in its entirety upon certain insolvency events involving the other party. Under the Seagen license agreement, we identified one performance obligation for the license grant. The transaction price consists of the $5.0 million non-refundable upfront fee. As t transaction price of $5.0 million was fully recognized. For the three and nine months ended September 30, 2020, no milestone payments were triggered under the Seagen license agreement. We will recognize any consideration related to sales-based payments (including milestones and royalties) when the related sales occur, as we have determined that these amounts relate predominantly to the license granted and therefore will be recognized on the later to occur of satisfaction of the performance obligation or the occurrence of the related sales. We will re-evaluate the transaction price for the in each reporting period as uncertain events are resolved and other changes in circumstances occur. |