Revenue Recognition | 12. Revenue Recognition The Company records revenue in accordance with ASC, Topic 606 “ Revenue from Contracts with Customers .” Under Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the entity performs the following five steps: (i) identifies the contract(s) with a customer; (ii) identifies the performance obligations in the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Following is a description of principal activities – separated by reportable segments – from which the Company generates its revenue (See Note 11 – Business Segment, Geographic, and Concentration Risk Information ). 1. Oncology Innovation Platform License fees and consulting revenue The Company out-licenses certain of its intellectual property (“IP”) and provides related consulting services to pharmaceutical companies in specific territories that allow the customer to use, develop, commercialize, or otherwise exploit the licensed IP. In accordance with Topic 606, the Company analyzes each of its out-licensing contracts with customers to identify each of the performance obligations within the contract. Each out-license contains multiple performance obligations. The Company has determined that each of its out-license agreements with customers are classified as functional licenses and are capable of being distinct, because the IP that is licensed carries standalone value and is not expected to be altered through the life of the agreement. Therefore, for each of its out-licensing agreements, the Company has determined that the execution of the license and delivery of the IP to the licensee is a distinct performance obligation. As such, the Company records revenue at a point-in-time for its out-licensing if any of the transaction price is allocated to the obligation, including up-front licensing fee payments. The Company’s classification of each out-licensing as such requires significant judgment to be used by management. The Company considers the economic and regulatory characteristics of the licensed IP to determine if it has standalone value on the date of the licensing, which would make the licensing distinct and dictate that the Company recognizes any transaction price allocated to the license performance obligation at a point-in-time. Revenue recognized at a point-in-time for the execution of a distinct licensing of IP amounted to $5.0 million and $0 for the three months ended September 30, 2018 and 2017, respectively, and $30.0 million and $0 for the nine months ended September 30, 2018 and 2017, respectively. Other performance obligations included in the Company’s out-licensing agreements include reaching milestone development and regulatory events by performing research and development activities over the licensed IP. The Company did not reach any milestone events during the nine months ended September 30, 2018 and reached one milestone event during the nine months ended September 30, 2017 resulting in $0.5 million of revenue recognized. The Company recorded the associated milestone payment as revenue at a point-in-time. Certain out-licensing agreements include performance obligations to manufacture and provide drug product in the future when the licensed product is approved for commercial sale. To date, the Company has not satisfied any of these performance obligations as none of its drugs have been approved by the regulatory agencies in each of the licensed territories. In addition to the multiple performance obligations, the Company’s out-licensing agreements include variable pricing. After the performance obligations are identified, the Company determines each portion of the transaction price, which generally includes upfront fees, milestone payments, and royalty payments. The Company begins by allocating the payments set forth in the agreement to the performance obligation to which the consideration is related. Then, the Company considers whether or not that transaction price is fixed, variable, or subject to return. If any portion of the transaction price is constrained by more than one performance obligation, the Company allocated that portion of the transaction price to the performance obligation that will be satisfied later and will not recognize revenue until it is fully satisfied and the constraint on the transaction price no longer exists. There are no other significant methods employed to allocate the transaction price to performance obligations in a contract. The Company exercises significant judgment when allocating the variable transaction prices to the proper performance obligations, considering if any of those payments are refundable or are contingent on any future events. Grant revenue The Company receives grant award funding to support its continuing research and development efforts. The Company considers these grants to be operating revenue as they support the Company’s primary operating activities. Revenue is recognized when the underlying performance obligation is satisfied, which is generally when all grant eligibility criteria are met at a point-in-time. Performance obligations in these contracts include various eligibility conditions that the Company must satisfy to maintain the grant agreement. Grant revenue is not significant to the consolidated financial statements. Performance obligations remaining as of September 30, 2018 were not material to the financial statements and do not significantly alter the Company’s business operations. Contracts for the grant revenue include a fixed transaction price and a single performance obligation. Therefore, the transaction price is allocated to the single obligation and there are no further allocation methods or assumptions used. 2. Global Supply Chain Platform The Company’s Global Supply Chain Platform manufactures API for use internally in its research and development and clinical studies and for sale to pharmaceutical customers globally. API revenue earned by the Global Supply Platform is recognized when the Company has satisfied its performance obligation, which is the shipment or the delivery of drug products. The underlying contracts for these sales are generally purchase orders and the Company recognizes revenue at a point-in-time. Any remaining performance obligations related to product sales are the result of customer deposits and are reflected in the deferred revenue contract liability balance. The Company also generates revenue, to a lesser extent, by providing small to mid-scale cGMP manufacturing of clinical and commercial products for pharmaceutical and biotech companies and selling pharmaceutical products under 503B regulations set forth by the FDA. 3. Commercial Platform The Company’s Commercial Platform generates revenue by distributing specialty products through independent pharmaceutical wholesalers. The wholesalers then sell to an end-user, normally a hospital, alternative healthcare facility, or an independent pharmacy, at a lower price previously established by the end-user and the Company. Sales are initially recorded at the list price sold to the wholesaler. Because these prices will be reduced for the end-user, the Company records a contra asset in accounts receivable and a reduction to revenue at the time of the sale, using the difference between the list price and the estimated end-user contract price. Upon the sale by the wholesaler to the end-user, the wholesaler will chargeback the difference between the original list price and price at which the product was sold to the end-user and such chargeback is offset against the initial estimated contra asset. The significant estimates inherent in the initial chargeback provision relate to wholesale units pending chargeback and to the ultimate end-user contract selling price. The Company bases the estimate for these factors on product-specific sales and internal chargeback processing experience, as well as estimated wholesaler inventory stocking levels. As of September 30, 2018 and December 31, 2017, the Company’s total provision for chargebacks and other deductions totaled $13.2 million and $3.7 million, respectively, included as a reduction of accounts receivable. The Company offers cash discounts, which approximate 2.0% of the gross sales price, as an incentive for prompt customer payment, and, consistent with industry practice, the Company’s return policy permits customers to return products within a window of time before and after the expiration of product dating. The Company expects that its wholesale customers will make prompt payments to take advantage of the cash discounts, and expects customers to use their right of return. Therefore, at the time of sale, product revenue and accounts receivable are reduced by the full amount of the discount offered and the return expected. The Company considers payment performance and historical return rates and adjusts the accrual to reflect actual experience. As of September 30, 2018 and December 31, 2017, the Company’s accrual for cash discounts and return accrual included as a reduction of accounts receivable were not material to the consolidated financial statements. The Company also offers contractual allowances, generally rebates or administrative fees, to certain wholesale customers, group purchasing organizations (“GPOs”), and end-user customers, consistent with pharmaceutical industry practices. Settlement of rebates and fees may generally occur from one to five months from date of sale. The Company provides a provision for contractual allowances at the time of sale based on the historical relationship between sales and such allowances. Contractual allowances are reflected in the consolidated financial statements as a reduction of revenue and accounts receivable or as accrued expenses. The Company exercises significant judgment in its estimates of the variable transaction price at the time of the sale and recognizes revenue when the performance obligation is satisfied. Factors that determine the final net transaction price include chargebacks, fees for service, cash discounts, rebates, returns, warranties, and other factors. The Company estimates all of these variables based on historical data obtained from previous sales finalized with the end-user customer on a product-by-product basis. At the time of sale, revenue is recorded net of each of these deductions. Through the normal course of business, the wholesaler will sell the product to the end-user, determining the actual chargeback, return products, and take advantage of cash discounts, charge fees for services, and claim warranties on products. The final transaction price per product is compared to the initial estimated net sale price and reviewed for accuracy. The final prices and other factors are immediately included in the Company’s historical data from which it will estimate the transaction price for future sales. The underlying contracts for these sales are generally purchase orders including a single performance obligation, generally the shipment or delivery of products and the Company recognizes this revenue at a point-in-time. Disaggregation of revenue The following represents the Company’s revenue for its reportable segment by country, based on the locations of the customer. For the Three Months Ended September 30, 2018 (In Thousands) Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 2,244 $ 7,315 $ 9,559 Spain 5,000 — — 5,000 India — 258 — 258 Austria — 2,227 — 2,227 China 117 189 — 306 Other foreign countries — 1,077 — 1,077 Total revenue $ 5,117 $ 5,996 $ 7,315 $ 18,428 For the Three Months Ended September 30, 2017 (In Thousands) Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 736 $ 7,378 $ 8,114 India — 3,015 — 3,015 Austria — 964 — 964 China 205 833 — 1,038 Other foreign countries — 863 — 863 Total revenue $ 205 $ 6,411 $ 7,378 $ 13,994 For the Nine Months Ended September 30, 2018 (In Thousands) Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 4,399 $ 23,006 $ 27,405 Spain 30,000 — — 30,000 India — 1,701 — 1,701 Austria — 5,102 — 5,102 China 532 1,385 — 1,917 Other foreign countries — 1,704 — 1,704 Total revenue $ 30,532 $ 14,291 $ 23,006 $ 67,829 For the Nine Months Ended September 30, 2017 (In Thousands) Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 1,781 $ 9,274 $ 11,055 India — 5,275 — 5,275 Austria — 2,682 — 2,682 China 708 1,058 — 1,766 Other foreign countries 500 1,892 — 2,392 Total revenue $ 1,208 $ 12,688 $ 9,274 $ 23,170 The Company also disaggregates its revenue by product group which can be found in Note 11 – Business Segment, Geographic, and Concentration Risk Information Contract balances The following table provides information about receivables and contract liabilities from contracts with customers. The Company has not recorded any contract assets from contracts with customers. September 30, 2018 December 31, 2017 (In Thousands) Accounts receivable, gross $ 20,252 $ 12,263 Chargebacks and other deductions (13,154 ) (3,711 ) Allowance for doubtful accounts (27 ) (84 ) Accounts receivable, net $ 7,071 $ 8,468 Deferred revenue $ 364 $ 1,202 Total contract liabilities $ 364 $ 1,202 The following tables illustrate accounts receivable balances by reportable segments. September 30, 2018 (In Thousands) Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total Accounts receivable, gross $ 9 $ 3,369 $ 16,874 $ 20,252 Chargebacks and other deductions — — (13,154 ) (13,154 ) Allowance for doubtful accounts — (27 ) — (27 ) Accounts receivable, net $ 9 $ 3,342 $ 3,720 $ 7,071 December 31, 2017 (In Thousands) Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total Accounts receivable, gross $ 49 $ 4,553 $ 7,661 $ 12,263 Allowance for doubtful accounts, chargebacks, and other deductions — (84 ) (3,711 ) (3,795 ) Accounts receivable, net $ 49 $ 4,469 $ 3,950 $ 8,468 As of September 30, 2018, $0.4 million of the deferred revenue balance relates to customer deposits made by customers of the Global Supply Chain Platform. As of December 31, 2017, the $1.2 million contract liability related to customer deposits made by customers of the Global Supply Chain Platform. The Company satisfied its performance obligations allocated to these contract liabilities during the nine months ended September 30, 2018. There were no other material changes to contract balances during the nine months ended September 30, 2018. Practical expedients used During the adoption of ASC 606, the Company applied the practical expedient in paragraph 606-10-10-4, the Portfolio Approach The Company applies the practical expedient in paragraph 606-10-50-14 and does not disclose information about remaining performance obligations related to the license of intellectual property (“IP”). This practical expedient is applied because the out-licensing agreements include sales-based royalties in exchange for the license of IP accounted for in accordance with Topic 606 and there is significant uncertainty surrounding the future variable consideration that could be received. |