Collaborative Arrangements and Revenue Recognition | 6. Collaborative Arrangements and Revenue Recognition Healios 2016 Inception of License Arrangement In 2016, we entered into a license agreement (“Healios Agreement”) with Healios to develop and commercialize MultiStem cell therapy for ischemic stroke in Japan and to provide Healios with access to our proprietary MAPC technology for use in its “organ bud” program, initially for transplantation to treat liver disease or dysfunction. Under the Healios Agreement, Healios obtained a right to expand the scope of the collaboration to include the exclusive rights to develop and commercialize MultiStem for the treatment of certain additional indications in Japan, which include acute respiratory distress syndrome (“ARDS”), and, as addressed herein, plans for an expansion of the collaboration are underway. Under the terms of the Healios Agreement, we received a nonrefundable, up-front For the ischemic stroke indication, we may also receive additional success-based development, regulatory approval and sales milestones, which are non-refundable non-creditable If Healios exercised its option to expand the collaboration to include ARDS and another indication in the orthopedic area under the Healios Agreement, we would be entitled to receive a cash payment of $10 million at the time of exercise and royalties from product sales and success-based development, regulatory approval and sales milestones, as well as payments for product supply related to the additional indications covered by the option. Under the proposed expansion plans addressed herein, at a minimum, Healios would exercise its option to include the ARDS field under the Healios Agreement, and the $10 million expansion fee was funded by Healios into an escrow account in March 2018, which is due to be released to us by June 1, 2018. For the “organ bud” product, we are entitled to receive a fractional royalty percentage on net sales of the “organ bud” products and will receive payments for manufactured product supplied to Healios under a manufacturing supply agreement. Additionally, we have a right of first negotiation for commercialization of an “organ bud” product in North America, with such right expiring on certain dates in the future. For the Healios arrangement, we identified all material performance obligations, which included a license to our technology, product supply services, and services related to transfer technology to a contract manufacture on Healios’ behalf. In order to determine the transaction price, in addition to the upfront payment, we estimated the amount of variable consideration at the outset of the contract utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. We constrain, or reduce, the estimates of variable consideration if it is probable that a significant reversal of previously recognized revenue could occur throughout the life of the contract. Both the likelihood and magnitude of a potential reversal of revenue are taken into consideration. These estimates are re-assessed Once the estimated transaction price is established, amounts are allocated to the performance obligations that have been identified. The transaction price is allocated to each separate performance obligation on a relative standalone selling price basis. We must develop assumptions that require judgment to determine the relative standalone selling price in order to account for our collaborative agreements, as these assumptions typically include probabilities of obtaining marketing approval for our product candidates, estimated timing and cost of development and commercialization, estimated future cash flows from potential product sales of our product candidates, and appropriate discount and tax rates. We do not include a financing component to our estimated transaction price at contract inception unless we estimate that the performance obligations will not be satisfied within one year. We determined that the license in the Healios arrangement was distinct from the other performance obligations identified in the arrangement, and that the license was transferred to Healios and Healios was able to use and benefit from the license. Furthermore, the product supply services and the technology transfer services provided to Healios were also determined to be distinct. We then allocated the transaction price based on the relative value prescribed to the license compared to the overall arrangement. As a result of the analysis, we allocated to the license $17.3 million of the proceeds received and to be received in the future. For performance obligations satisfied over time, we apply an appropriate method of measuring progress each reporting period and, if necessary, adjust the estimates of performance and the related revenue recognition. For our technology transfer services provided to Healios that are satisfied over time, we recognize revenue in proportion to the contractual services provided. We computed the effect of the adoption of Topic 606, which is included in the cumulative effect adjustment as of January 1, 2018. Overall, the conclusions under the former guidance related to performance obligations, obligations being distinct within the contract and relative standalone selling prices did not change with the adoption of the new guidance. However, the transaction price was higher under Topic 606 since revenue recognition is no longer limited to cash proceeds received, and we were able to recognize more revenue for the delivered license. This additional revenue of $1.9 million was accounted for as a decrease to our accumulated deficit at January 1, 2018 and an increase to a contract asset and to a lesser extent, a decrease to deferred revenue. The contract asset was evaluated at March 31, 2018, noting that it is properly classified as a current asset since the conditional rights to consideration are expected to be satisfied within one year. 2017 Amendment – Cost Share In January 2017, we signed a clinical trial supply agreement for the manufacturing of investigational product for Healios for its Japan clinical study, the terms of which were consistent with the Healios Agreement. The clinical trial supply agreement was amended in July 2017 to clarify a cost-sharing arrangement associated with our supply of clinical product. The proceeds from Healios that relate specifically to the cost-sharing arrangement may result in a reduction in the proceeds we receive from Healios upon the achievement of two future milestones, and an increase to a later-stage commercial milestone. While the amendment to the supply agreement resulted in a revision to the terms associated with the product supply under the Healios Agreement, namely the cost of product supply, the revision did not affect any of the performance obligations under the overall arrangement. The cost-sharing proceeds received are recognized on the balance sheets as a non-current 2017 Technology Transfer Services In September 2017, we entered into a services agreement with Healios, in which Healios provides financial support to establish a contract manufacturer in Japan to produce product for Healios, and services began in the fourth quarter of 2017. We evaluated this agreement as combined with the Healios Agreement due to its connection to the license and the product supply under the Healios Agreement. The costs of the services, representing our performance obligation, are reimbursed by Healios at our cost. Given that Healios will benefit from the services as the services are performed, which is the intended purpose of the arrangement, we concluded that the services were distinct. We estimated the relative standalone value of the technology transfer services, which was included in the allocation of the transaction price for the overall Healios arrangement. The technology transfer services are recognized over time as the services are performed. Furthermore, in September 2017, we amended the Healios Agreement to confer to Healios a limited license to manufacture MultiStem in the event that we are acquired by a third party. Such amendment was evaluated as a combined agreement along with the Healios Agreement and had no impact on the allocation of revenue to the remaining undelivered items. 2018 Planned Expansion In March 2018, we entered into a letter of intent (as amended in April 2018, the “LOI”) with Healios to significantly expand Healios’ license to develop MultiStem products and enter into a Collaboration Expansion Agreement (the “Collaboration Expansion Agreement”). Under the terms of the LOI, we and Healios will work to execute the agreements necessary to expand the existing collaboration by May 31, 2018. If the Collaboration Expansion Agreement is entered into in accordance with the terms of the LOI, Healios would (i) expand its license to include ARDS (including idiopathic pulmonary fibrosis) and trauma in Japan, and use of MultiStem worldwide for organ buds for all organ diseases, (ii) obtain a worldwide exclusive license for use of MultiStem product to treat certain ophthalmological indications, (iii) obtain an exclusive option to a license to develop and commercialize MultiStem products for ischemic stroke, ARDS and trauma in China, and (iv) obtain certain other rights. In exchange, if the Collaboration Expansion Agreement is entered into as contemplated by the LOI, we would be entitled to receive payments of $35 million ($10 million of which was funded in an escrow account to be paid to us upon execution), as well as additional possible payments, including milestones and royalties. Under the Collaboration Expansion Agreement, the remaining $25 million payment obligation would be paid in instalments that cannot be terminated over time, and though the payments would be non-refundable, Under the binding terms of the LOI, we and Healios entered into an escrow agreement in March 2018, and Healios funded $10 million into the escrow account, which is to be paid to us no later than June 1, 2018 as either (i) a portion of the $35 million in payments associated with the execution of the Collaboration Expansion Agreement, or (ii) if Collaboration Expansion Agreement is not executed on or before May 31, 2018, payment for expanding the scope of the existing Healios Agreement to include ARDS and certain ophthalmological indications in Japan and use of MultiStem for organ buds for all organ diseases. Also see Note 3 regarding our revenue recognition policies and Note 8 regarding the equity investment made by Healios in the first quarter of 2018 in connection with the planned expansion of the collaboration, and the issuance of a warrant to Healios. Other Under our agreement with RTI to develop and commercialize biologic implants using our technology for certain orthopedic applications in the bone graft substitutes market, we are eligible to receive up to $34.5 million in remaining cash payments upon the successful achievement of certain commercial milestones, after the first commercial milestone payment of $1.0 million was received in the first quarter of 2017. No milestone revenues were received in the first quarter of 2018. In addition, we receive tiered royalties on worldwide commercial sales of implants using our technologies based on a royalty rate starting in the mid-single mid-teens, In January 2017, we received an option fee related to an agreement with a global leader in the animal health business segment to evaluate our cell therapy technology for application in an animal health area. Under the terms of the agreement, we received the payment in exchange for an exclusive period to evaluate our cell therapy technology with an option to negotiate for a license for the development and commercialization of the technology for the animal health area. The option fee is recorded as deferred revenue at March 31, 2018 since the performance obligation of granting a license has not occurred. If the option is exercised, we will include the option fee in the overall consideration for the license arrangement, to be evaluated at that time. If the option is not exercised, the option fee will be recognized as revenue at that time since there will be no more performance obligations. The evaluation of our technology for this application is currently ongoing. |