Revenue from Contracts with Customers | Revenue from Contracts with Customers The Company adopted ASC 606 on January 1, 2018, using the modified retrospective method for all contracts not completed as of the date of adoption. The reported results for 2018 reflect the application of ASC 606 guidance while the reported results for 2017 were prepared under the guidance of ASC 605, Revenue Recognition (ASC 605), which is also referred to herein as "legacy GAAP" or the "previous guidance". The adoption of ASC 606 represents a change in accounting principle that will more closely align revenue recognition with the delivery of the Company's services and will provide financial statement readers with enhanced disclosures. Financial Statement Impact of Adopting ASC 606 The cumulative effect of applying the new guidance to all contracts with customers that were not completed as of January 1, 2018, was recorded as an adjustment to accumulated deficit as of the adoption date. As a result of applying the modified retrospective method to adopt the new revenue guidance, the following adjustments were made to the Company's accounts on the condensed consolidated balance sheet as of January 1, 2018: Adjustments As Reported at Due to Balance at Consolidated Balance Sheet December 31, 2017 ASU 2014-09 January 1, 2018 Assets Cash, cash equivalents, and restricted cash $ 70,698 $ — $ 70,698 Short-term deposits and investments 25,940 — 25,940 Accounts receivable 63 — 63 Prepaid expenses and other current assets 1,979 231 2,210 Total current assets 98,680 231 98,911 Property and equipment, net 2,091 — 2,091 Restricted cash and other assets 329 2,367 2,696 Total assets $ 101,100 $ 2,598 $ 103,698 Liabilities and stockholders’ equity Current liabilities: Accounts payable 1,606 — 1,606 Accrued expenses 8,580 — 8,580 Deferred revenue, current portion 787 — 787 Total current liabilities 10,973 — 10,973 Non‑current liabilities: Deferred rent and lease incentive 151 — 151 Loans payable, net of current portion 21,042 — 21,042 Deferred revenue, net of current portion 15,919 (1,830 ) 14,089 Other long‑term liabilities 1,201 — 1,201 Total liabilities 49,286 (1,830 ) 47,456 Stockholders’ equity: Common stock 3 — 3 Additional paid-in capital 273,128 — 273,128 Accumulated deficit (216,897 ) 4,428 (212,469 ) Accumulated other comprehensive loss (4,420 ) — (4,420 ) Total stockholders’ equity 51,814 4,428 56,242 Total liabilities and stockholders’ equity $ 101,100 $ 2,598 $ 103,698 In connection with the adoption of ASC 606, the Company identified three collaboration/grant arrangements that required analysis to quantify the impact of adoption to its opening accumulated deficit balance as of January 1, 2018: Spark Therapeutics, Inc., Skolkovo Foundation and National Institutes of Health. Spark Therapeutics, Inc. Spark License Agreement In December 2016, the Company entered into a License and Option Agreement (“Spark License Agreement”) with Spark Therapeutics, Inc. (“Spark”) pursuant to which the Company and Spark agreed to collaborate on the development of gene therapies for certain targets utilizing the SVP™ technology. The Spark License Agreement provides Spark with certain exclusive, worldwide, royalty bearing licenses to the Company’s intellectual property, allowing Spark to develop and commercialize gene therapies for an initial identified target. In addition to an upfront cash payment of $10.0 million under the Spark License Agreement, additional payments of an aggregate of $5.0 million in two payments of $2.5 million each were paid within twelve months of December 2, 2016 (“Contract Date”). The first of the two additional payments was scheduled to be made on or before May 31, 2017 (the “May 2017 License Payment”) (see “Spark Letter Agreement” below) and the second was made on October 31, 2017. Spark may also exercise options to research, develop and commercialize gene therapies utilizing the SVP technology for up to four additional targets. The Company is eligible to receive a variable fee up to $2.0 million for each additional target option elected, dependent on the incidence of the applicable indication. As per the agreement, the election period in which Spark can exercise additional targets is a term of three years from the Contract Date, or December 1, 2019. Assuming successful development and commercialization, the Company could receive up to an additional $65.0 million in development and regulatory milestone payments and $365.0 million in commercialization milestone payments for each indication. If commercialized, the Company would be eligible to receive tiered royalties on global net sales at percentages ranging from mid-single to low-double digits, all of which apply on a target-by-target basis. Under the terms of the agreement, the Company will be eligible to receive these royalties commencing on the first commercial sale of the licensed product and terminating upon the later of (i) ten years after the first commercial sale, (ii) expiration of the last to expire valid claim on patents covering the jointly invented field specific improvements, or (iii) the expiration of regulatory exclusivity in the applicable country for the licensed product. The Spark License Agreement may be terminated by Spark for convenience upon ninety days’ notice. Either party may terminate the Spark License Agreement on a target-by-target basis for material breach with respect to such target. In December 2016, the Company also entered into a Share Purchase Agreement (the “Spark Purchase Agreement”) with Spark. Pursuant to the Spark Purchase Agreement, the Company sold 197,238 shares of the Company’s common stock to Spark for gross proceeds of $5.0 million , or $25.35 per share of common stock, at an initial closing (the “Initial Closing”). The purchase price per share represents an amount equal to 115% of the average daily volume weighted average price (“VWAP”) of the common stock during the thirty consecutive calendar days leading up to and ending on the day prior to the Contract Date. Under the Spark Purchase Agreement, Spark has agreed not to dispose of any of the Initial Closing Shares or any Acquisition Right Shares that it may acquire until January 1, 2018 and, thereafter, transfers will be contractually subject to volume limitations applicable to an “affiliate” under Rule 144 of the Securities Act. Closings under the Spark Purchase Agreement are subject to customary conditions. Beyond the Initial Closing, the Spark Purchase Agreement contemplated potential future sales of shares by the Company to Spark as follows: • First Acquisition Right. During the period beginning on May 1, 2017 and ending on June 1, 2017, Spark had the right (the “First Acquisition Right”) to purchase a number of shares of common stock equal to an aggregate price of $5.0 million . See "Spark Letter Agreement" below. • Second Acquisition Right. During the period beginning on October 1, 2017 and ending on November 1, 2017, Spark had the right (the “Second Acquisition Right”) to purchase a number of shares of common stock equal to an aggregate price of $5.0 million . On October 31, 2017 Spark exercised this right and purchased 205,254 shares of common stock from the Company for $5.0 million , or $24.36 per share of common stock. The purchase price per share represents an amount equal to 115.0% of the average daily VWAP of the common stock during the thirty consecutive calendar days leading up to and ending on the day prior to the Second Acquisition Right notification date. The First Acquisition Rights and Second Acquisition Rights are collectively referred to herein as the “Acquisition Rights”. The aggregate number of shares that the Company may issue pursuant to the Stock Purchase Agreement may not exceed the lesser of (i) 2,758,112 shares and (ii) such number of shares that would require the Company to obtain prior shareholder approval under the Nasdaq Marketplace Rules. In connection with the Spark License Agreement and Spark Purchase Agreement, the Company has made contractual payments defined in the MIT license agreement (Note 14) totaling $2.2 million for the MIT sub-license provided to Spark, and $0.4 million relative to the calculated premium paid by Spark for the equity investments made under the Spark Purchase Agreement. Transition of Revenue Recognition from ASC Topic 605 to ASC Topic 606 The terms of the Spark Purchase Agreement and the Spark License Agreement were negotiated at the same time between the parties and the terms of the Spark Purchase Agreement are referenced in the Spark License Agreement in multiple sections. The pricing and terms of the agreements are unique and must be considered in contemplation with each other. There are provisions within the Spark License Agreement that link to the Spark Purchase Agreement related to provisions that constitute a material breach of the license agreement. Therefore, the Company concluded that the two agreements must be combined and evaluated as a single agreement. While the Spark Purchase Agreement and the Spark License agreement are considered to be a single agreement, the Company determined that the purchase of common stock and future acquisition rights are not within the scope of ASC 606. The Company determined that the initial purchase of common stock combined with the embedded future stock Acquisition Rights had a fair value of $2.7 million and this amount was recorded in equity as of the effective date. The remaining $2.3 million of cash received in exchange for the stock and acquisition rights is included in allocable consideration, as this represents the premium paid by Spark on the purchase of common stock, and should be allocated to the remaining performance obligations. The Company identified the following promises at the inception of the agreement: (1) certain exclusive, worldwide, royalty bearing licenses to the Company’s intellectual property and a license to conduct certain research activities under the collaboration, or the License Obligation, (2) options to research, develop and commercialize gene therapies utilizing the SVP technology for up to four additional target therapy options, or the Option Obligation, (3) manufactured supply of pre-clinical and clinical SVP, or the Supply Obligation at a discount, and (4) option to purchase manufactured supply of commercial SVP, or the Commercial Supply Obligation at fair value. In consideration for these promises, the Company received an upfront payment of $15.0 million . In addition, the Company is eligible to receive additional payments of up to $35.0 million based on the achievement by Spark of future specified development milestones, up to $30.0 million based on the achievement by Spark of future specified regulatory milestones, up to $110.0 million based on the achievement by Spark of future specified commercial milestones, and up to $255.0 million based on the achievement by Spark of future specified sales milestones. The Company will also be eligible to receive tiered royalty payments that reach low double-digits based on future net sales for the duration of the royalty term. The Company determined that the License Obligation was not capable of being distinct from the Supply Obligation. This is because Spark cannot derive benefit from the license without the simultaneous transfer of the pre-clinical and clinical supply. Therefore, the License Obligation and Supply Obligation are combined as a single performance obligation (the “Combined License and Supply Obligation”). The Company also determined that the Option Obligation, which includes the related Supply Obligation, provides the customer with a material right and is considered a performance obligation in the arrangement since it was priced at an incremental discount. The Company determined that the optional Commercial Supply Obligation does not provide the customer with a material right and is not considered to be a performance obligation because Spark can derive benefit from the Combined License and Supply Obligation without the delivery of the Commercial Supply Obligation and is not at an incremental discount. Therefore, the Company determined that the Spark agreement contains five distinct performance obligations: the Combined License and Supply Obligation, and the four separate Option Obligations. In determining the transaction price, the Company considered the future development milestones, regulatory milestones, commercial milestones, sales milestone, and sales royalties all represent variable consideration. Each of these variable consideration items was evaluated under the most likely amount method to determine whether such amounts were probable of occurrence, or whether such amounts should be constrained until they become probable. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of such milestones is outside the control of the Company. Separately, any consideration related to sales-based milestones as well as royalties on net sales upon commercialization by Spark, will be recognized when the related sales occur as they were determined to relate predominantly to the intellectual property granted to Spark and, therefore, have also been excluded from the transaction price in accordance with the royalty recognition constraint. As of the adoption date and as of March 31, 2018, all milestones were constrained. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur. As a result, the Company determined that the up-front payment of $12.3 million ( $15.0 million , less fair value of the equity totaling $2.7 million as discussed above) was included in the transaction price and was allocated to the performance obligations based on the Company’s best estimate of their relative stand-alone selling prices. The Company allocated $7.1 million to the Combined License and Supply Obligation and $5.2 million to the discount on the Option Obligation ( $1.3 million for each option) using the relative standalone selling price method to each obligation. The standalone selling price for the Combined License and Supply Obligation was determined using a discounted cash flow model. The standalone selling price for the Option Obligation was determined based on the fair value of the license minus the strike price of the option (the probability of exercise was included in the valuation) as well as the estimated discount of the Supply Obligation. The estimated proceeds to be received from the sale of the Supply Obligation was also included in the transaction price for the Combined License and Supply Obligation. The total consideration allocated to the Combined License and Supply Obligation will be recognized using the output method, based on the proportion of actual deliveries to the total expected deliveries over the initial term which is estimated to be approximately four years. The discount associated with the Option Obligation, along with the proceeds to be received upon exercise and estimated sale of the Supply Obligation, will be recognized when each of the options are exercised, over the related expected deliveries of its supply. If the options expire without exercise, the related deferred revenue associated with each option will be recognized upon expiration (December 1, 2019). The Company estimated that revenue recognized under ASC 605 is consistent with the revenue recognized in accordance with ASC 606 from contract inception. However, upon adoption of ASC 606, the Company recognized other assets of $2.6 million related to the incremental costs relating to sublicense fees, and a premium, paid to MIT that would not have been incurred if the contract with Spark had not been obtained. The Company recognized revenues of zero and less than $0.1 million related to the Spark License Agreement during the three months ended March 31, 2018 and 2017, respectively. As of March 31, 2018 , there was a contract liability of $14.7 million representing deferred revenue associated with this agreement. A total of $1.0 million is presented as current and $13.7 million is presented as noncurrent in the accompanying consolidated balance sheet. As of December 31, 2017 , there was $14.7 million of deferred revenue related to this agreement. A total of $0.8 million was presented as current and $13.9 million was presented as noncurrent in the accompanying consolidated balance sheet. Spark Letter Agreement On June 6, 2017, the Company and Spark entered into a letter agreement (the “Letter Agreement”), pursuant to which the parties agreed that Spark would make the May 2017 License Payment by June 6, 2017. The May 2017 License Payment was received, and recorded as a liability as of June 30, 2017, of which some or all may potentially constitute the reimbursement described below. The parties also agreed that Spark would be deemed to have delivered notice on May 31, 2017 exercising its right to purchase the shares pursuant to the First Acquisition Right. The Letter Agreement further outlines a cost reimbursement arrangement, pursuant to which the Company agreed to reimburse Spark for all costs and expenses, including the cost of materials provided by the Company, associated with the preclinical research and toxicology studies being performed by Spark for any licensed products for a specified amount of time (the “Reimbursement Period”), up to an agreed upon cap of $2.5 million . Consistent with the First Acquisition Right, Spark purchased 324,362 shares of common stock pursuant to the Spark Purchase Agreement, as amended by the Letter Agreement, for an aggregate purchase price of $5.0 million , or $15.41 per share of common stock. The purchase price per share represents an amount equal to 115.0% of the average daily volume weighted average price (“VWAP”) of the common stock during the thirty consecutive calendar days leading up to and ending on the day prior to the First Acquisition Right notification date. At the initial contract assessment, the Company allocated $2.7 million to equity (representing the fair value of the initial purchase of common stock combined with the embedded future stock Acquisition Rights). Upon exercise of the First Acquisition Right, the Company recorded the purchase amount to stockholders ’ equity. Under ASC 606, the Company determined that the Letter Agreement resulted in a modification to the original agreement. The amount received totaling $2.5 million and the reimbursements pursuant to the Letter Agreement totaling $2.5 million were both included in the transaction price, and a contract liability was recorded for the amount expected to be repaid. As repayments are made, the underlying contract liability will be reduced. To the extent that an amount is expected to be applied towards the clinical supply obligation, the analysis of variable consideration will be updated accordingly. The Company utilized the practical expedient relating to contract modifications that occurred prior to January 1, 2018. The practical expedient allows the Company to reflect the aggregate effect of all modifications that occurred before January 1, 2018 when identifying the satisfied and unsatisfied performance obligations, determining the transaction price and allocating the transaction price to the satisfied and unsatisfied performance obligations for the modified contract at transition. On October 31, 2017, Spark paid the Company a $2.5 million milestone payment pursuant to the Spark License Agreement, which was included in the transaction price and allocated to the performance obligations using the relative standalone selling price. In addition, Spark exercised the Second Acquisition Right set forth in Section 2.4 of the Spark Purchase Agreement and purchased 205,254 shares of common stock from the Company for $5.0 million , or $24.36 per share of common stock. The purchase price per share represents an amount equal to 115.0% of the average daily VWAP of the common stock during the thirty consecutive calendar days leading up to and ending on the day prior to the Second Acquisition Right notification date. Skolkovo Foundation The Company receives grant funding from the Russia-based Development Fund of New Technologies Development and Commercialization Center ("Skolkovo"). On November 28, 2014, the Company executed a grant awarded by Skolkovo for the development of a therapeutic vaccine using nanoparticles to treat chronic infection caused by human papillomavirus (HPV) and diseases associated with this infection. The grant covers the period from August 1, 2014 through July 21, 2017. The grant provides for up to $2.7 million that covers 48.5% of the estimated total cost of the research plan with the remaining 51.5% of estimated costs to be contributed by the Company. From grant inception through March 31, 2018, the Company has received $2.0 million from Skolkovo. At any time during the term of the grant agreement, but not more than once per quarter, Skolkovo has the right to request information related to the project and to conduct an audit of the expenses incurred by the Company. In the event the project or the expenses do not meet predefined requirements, the Company may be required to reimburse the funds received up to three years after the completion of the project. As a result, in accordance with ASC 605, the Company determined that the grant funding was not fixed or determinable and the entire amount received through December 31, 2017 was recorded as deferred revenue in the consolidated balance sheet until the completion of the Skolkovo audit or the expiration of the audit term. The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Skolkovo, is a customer. Furthermore, the Company determined that the agreement with Skolkovo has commercial substance, and that the grant should be accounted for as revenue. The Company identified the research and development services being provided to Skolkovo as the only performance obligation in the agreement. Based on the guidance in ASC 606, the Company concluded that the entire $2.0 million of grant funds received from Skolkovo is variable consideration. Although the Company believes it has an enforceable right to the amounts received, there is risk that an audit could result in the Company needing to refund certain amounts back to Skolkovo, resulting in variability in the transaction price. The Company utilized the “expected value” approach in determining the amount that can be recognized. The Company estimated that it will be entitled to revenue of $1.8 million from the Skolkovo grant, and recorded this amount as a cumulative-effect adjustment through accumulated deficit upon adoption of ASC 606. The remainder of $0.2 million has been recorded as a contract liability upon adoption of ASC 606. National Institutes of Health On May 14, 2014, the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health ("NIH"), provided the Company with a Notice of Award (“NoA”), for a grant relating to the preclinical development and clinical proof of concept for a synthetic nanoparticle (the “Project”). The grant will help advance the Company’s development of the nanoparticle from a preclinical through early clinical stage and will provide support for one or more clinical trials. Under the terms of the grant, NIDA agreed to provide up to $8.1 million in funding to be used to offset the qualifying expenses incurred by the Company. The grant was to be funded over the course of three years, according to budget forecasts prepared by the Company. In accordance with ASC 605, revenue associated with this grant was recognized as the related research and development work was performed, and expenses incurred. Revenue under this grant arrangement was recognized using a proportional performance method. Amounts received prior to satisfying the ASC 605 revenue recognition criteria (if any) was recorded as deferred revenue on the balance sheet. Through December 31, 2017, the Company received and recognized under ASC 605 approximately $7.2 million of grant revenue. The remaining $0.9 million available under the grant requires a change to the overhead rate, which is subject to final reconciliation and approval from NIDA and, therefore, was not recognized under ASC 605. The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, NIDA, is a customer. Furthermore, the Company determined that the agreement with NIDA has commercial substance, and that the grant should be accounted for as revenue. The Company identified the research and development services being provided to NIDA as the only performance obligation in the agreement. Upon adoption of ASC 606, the remaining $0.9 million was not recognized because the change to the overhead rate requires approval from NIDA, and therefore, represents a contract modification. Revenue will be recognized if and when the price change is approved, at which time it will be an enforceable right under contract. The Company expects approval in 2018. Impact of New Revenue Guidance on Financial Statement Line Items The following table compares the reported condensed consolidated balance sheet and statement of operations, as of and for the three months ended March 31, 2018, to the pro-forma amounts had the previous guidance been in effect: As of March 31, 2018 Consolidated Balance Sheet As reported Pro forma as if the previous accounting was in effect Assets Cash, cash equivalents, and restricted cash $ 58,304 $ 58,304 Short-term deposits and investments 24,839 24,839 Accounts receivable 52 52 Prepaid expenses and other current assets 1,789 1,558 Total current assets 84,984 84,753 Property and equipment, net 2,257 2,257 Restricted cash and other assets 2,696 329 Total assets $ 89,937 $ 87,339 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 1,789 1,789 Accrued expenses 9,062 9,062 Deferred revenue, current portion 959 959 Total current liabilities 11,810 11,810 Non‑current liabilities: Deferred rent and lease incentive 129 129 Loans payable, net of current portion 21,127 21,127 Deferred revenue, net of current portion 13,917 15,747 Other long‑term liabilities 1,372 1,372 Total liabilities 48,355 50,185 Stockholders’ equity: Common stock 3 3 Additional paid-in capital 274,334 274,334 Accumulated deficit (228,357 ) (232,785 ) Accumulated other comprehensive loss (4,398 ) (4,398 ) Total stockholders’ equity 41,582 37,154 Total liabilities and stockholders’ equity $ 89,937 $ 87,339 Total reported assets were $2.6 million more than the pro-forma balance sheet, which assumes the previous guidance remained in effect as of March 31, 2018. The higher reported assets were a result of the recognition of other assets of $2.6 million relating to incremental costs of obtaining the contract with Spark. Total reported liabilities were $1.8 million less than the pro-forma balance sheet, which assumes the previous guidance remained in effect as of March 31, 2018. The lower reported liabilities were due to reductions recognized to deferred revenue balances, as follows: less than $0.1 million relating to Spark, and $1.8 million related to Skolkovo. There was no difference in the amounts reported in the statement of operations under ASC 606 during the three months ended March 31, 2018, and the pro-forma statement of operations, which assumes the previous guidance remained in effect as of March 31, 2018. Transaction Price Allocated to Future Performance Obligations Remaining performance obligations represent the transaction price of contracts for which work has not been performed (or has been partially performed) and excludes unexercised contract options. As of March 31, 2018 , the aggregate amount of the transaction price allocated to remaining performance obligations was $8.6 million . The Company expects to recognize revenue on approximately 9.0% of the remaining performance obligations over the next 12 months. Contract Balances from Contracts with Customers The following table presents changes in the Company’s contract liabilities during the three months ended March 31, 2018 (in thousands): Balance at Balance at Beginning of Period Additions Deductions End of Period Three Months Ended March 31, 2018 Contract liabilities: Deferred revenue $ 14,876 $ — $ — $ 14,876 Other liabilities (i) 2,231 — — 2,231 Total contract liabilities $ 17,107 $ — $ — $ 17,107 (i) The current portion of other liabilities in the amount of $0.8 million is presented in the accrued expenses line of the consolidated balance sheet. The noncurrent portion of other liabilities in the amount of $1.4 million is presented in the other long-term liabilities line of the consolidated balance sheet. The timing of revenue recognition and cash collections results in contract liabilities on the consolidated balance sheets. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded. Contract liabilities are recognized as revenue after control of the products or services is transferred to the customer and all revenue recognition criteria have been met. |