Collaboration Agreements | 3. Collaboration Agreements On January 1, 2018, the Company adopted Topic 606 using the modified retrospective transition method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting under Topic 605. AbbVie In December 2011, the Company entered into the AbbVie collaboration agreement to jointly research, develop, and commercialize the Company’s portfolio of second and later generation oral Nrf2 activators. The terms of the agreement include payment to the Company of a nonrefundable, up-front payment of $400,000,000 and development cost sharing for jointly developing indications after certain initial early development costs were incurred by the Company. The Company evaluated the AbbVie collaboration agreement under Topic 606 and determined that the upfront payment constituted the transaction price. The Company identified three performance obligations at contract inception: (1) the exclusive license rights to research, develop, and commercialize Nrf2 activators outside the United States, (2) the obligation to participate in Joint Steering Committees (JSCs), and (3) cost sharing for jointly developed indications. The transaction price was allocated to the exclusive license rights and the obligation to participate on JSCs, which are accounted for as a single performance obligation, and is being recognized as revenue ratably through December 2026, which is the estimated minimum period that is needed to complete the deliverables under the terms of the AbbVie Collaboration Agreement. The Company records shared development cost payments from AbbVie as reductions of research and development expense. As the Company is currently unilaterally developing its lead Nrf2 activator omaveloxolone, no amounts were recognized during the six months ended June 30, 2018. The adoption of Topic 606 did not result in a significant change in revenue recognition for this agreement. As of January 1, 2018, the Company’s deferred revenue balance was $238,292,000, which represents the contract liability for the unsatisfied performance obligations as well as the variable consideration paid in advance that is being recognized ratably through December 2026. The Company began recognizing revenue related to the up-front payment upon execution of the agreement and, accordingly, recognized approximately $6,644,000 and $13,214,000 as collaboration revenue during the three and six months ended June 30, 2018, respectively. As of June 30, 2018, the Company has a remaining deferred revenue balance totaling approximately $225,078,000. KHK In December 2009, the Company entered into the KHK agreement, which granted KHK an exclusive license to develop and commercialize bardoxolone methyl in the licensed territory. The Company received a nonrefundable, up-front license fee of $35,000,000 in 2009 and regulatory milestones totaling $15,000,000 in 2010 and 2012 and could receive additional regulatory milestones of $82,000,000 and commercial milestones of $140,000,000, as well as tiered royalties ranging from the low teens to the low 20 percent range, depending on the country of sale and the amount of annual net sales, on net sales by KHK in the licensed territory. The Company evaluated the KHK agreement under Topic 606 and identified three performance obligations at contract inception: (1) the exclusive license rights to develop and commercialize bardoxolone methyl in Japan and licensed territory, (2) the obligation to participate in JSCs, and (3) the obligation to supply bardoxolone methyl for KHK’s clinical trial and commercial needs. The transaction price was allocated to the exclusive license rights and the obligation to participate on JSCs, which are accounted for as a single performance obligation and is recognized as revenue ratably through December 2021, which is the estimated minimum period to complete the performance obligation under the KHK agreement. Any consideration related to the Company’s obligation to supply KHK with drug product is recognized upon delivery. Upon adoption of Topic 606, the Company determined that the transaction price for this agreement at contract inception includes the upfront fee of $35,000,000 and regulatory milestones of $15,000,000 received. In May 2018, the Company achieved its regulatory milestone of $30,000,000. The Company believes the remaining additional regulatory milestones of $52,000,000 and commercial milestones of $140,000,000 are fully constrained as they are not within the control of the Company or KHK and did not include these remaining milestones in the transaction price. Any consideration related to royalties will be recognized when the related sales occur. During the six months ended June 30, 2018, the Company added the regulatory milestone of $30,000,000 as variable consideration to the transaction price. For the six months ended June 30, 2018, the Company recorded $30,000,000 in receivables from collaboration arrangements on the balance sheet and $25,384,000 in collaboration revenue, including a cumulative catch-up for the portion of this milestone that was satisfied in prior periods. The remainder of $4,616,000 was recorded in deferred revenue on the balance sheet and will be recognized over the remaining performance obligation period. The Company recognized approximately $875,000 and $26,472,000 as collaboration revenue during the three and six months ended June 30, 2018, respectively. The Company also recognized related license fees and other expenses of approximately $3,600,000 related to achievement of this milestone. Due to the adoption of Topic 606, for the three and six months ended June 30, 2018, collaboration revenue was decreased and net loss was increased by $29,508,000 and $4,298,000, respectively. Additionally, the adoption resulted in an increase in basic and diluted net loss per share of $1.13 and $0.16, for the three and six months ended June 30, 2018, respectively. As of June 30, 2018, the Company’s deferred revenue balance was $12,308,000, which represents the contract liability for the unsatisfied performance obligations as well as the variable consideration paid in advance and achieved that is being recognized ratably through the remaining performance obligation period. |