Revenue Recognition | 17. 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. Below is a description of principal activities – separated by reportable segments – from which the Company generates its revenue (See Note 16 – Business Segment, Geographic, and Concentration Risk Information ). 1. The Company out-licenses certain of its IP to other 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 the contracts to identify its performance obligations within the contract. Most of the Company’s out-license arrangements contain multiple performance obligations and variable pricing. After the performance obligations are identified, the Company determines the transaction price, which generally includes upfront fees, milestone payments related to the achievement of developmental, regulatory, or commercial goals, and royalty payments on net sales of licensed products. The Company considers whether the transaction price is fixed or variable, and whether such is subject to return. Variable consideration is only included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. If any portion of the transaction price is constrained, it is excluded from the transaction price until the constraint no longer exists. The Company then allocates the transaction price to the performance obligation to which the consideration is related. Where a portion of the transaction price is received and allocated to continuing performance obligations under the terms of the arrangement, it is recorded as deferred revenue and recognized as revenue when (or as) the underlying performance obligation is satisfied. The Company’s contracts may contain one or multiple promises, including the license of IP and development services. The licensed IP is capable of being distinct from the other performance obligations identified in the contract and is distinct within the context of the contract, as upon transfer of the IP, the customer is able to use and benefit from it, and the customer could obtain the development services from other parties. The Company also considers the economic and regulatory characteristics of the licensed IP and other promises in the contract to determine if it is a distinct performance obligation. The Company considers if the IP is modified or enhanced by other performance obligations through the life of the agreement and whether the customer is contractually or practically required to use updated IP. The IP licensed by the Company has been determined to be functional IP. The IP is not modified during the license period and therefore, the Company recognizes revenues from any portion of the transaction price allocated to the licensed IP when the license is transferred to the customer and they can benefit from the right to use the IP. The Company recognized revenue allocated to the licensed IP performance obligation upon transfer of the license of $0.1 million and $30.0 million for the years ended December 31, 2019 and 2018, respectively. Other performance obligations included in most of the Company’s out-licensing agreements include performing development services to reach clinical and regulatory milestone events. The Company satisfies these performance obligations at a point-in-time, because the customer does not simultaneously receive and consume the benefits as the development occurs, the development does not create or enhance an asset controlled by the customer, and the development does not create an asset with no alternative use. The Company considers milestone payments to be variable consideration measured using the most likely amount method, as the entitlement to the consideration is contingent on the occurrence or nonoccurrence of future events. The Company allocates each variable milestone payment to the associated milestone performance obligation, as the variable payment relates directly to the Company’s efforts to satisfy the performance obligation and such allocation depicts the amount of consideration to which the Company expects to be entitled for satisfying the corresponding performance obligation. The Company re-evaluates the probability of achievement of such performance obligations and any related constraint, and adjusts its estimate of the transaction price as appropriate. To date, no amounts have been constrained in the initial or subsequent assessments of the transaction price. The Company recognized revenue allocated to development performance obligations upon transfer to the customer of $20.0 million and $2.0 million for the years ended December 31, 2019 and 2018, respectively. Certain out-license agreements include performance obligations to manufacture and provide drug product in the future for commercial sale when the licensed product is approved. For the commercial, sales-based royalties, the consideration is predominantly related to the licensed IP and is contingent on the customer’s subsequent sales to another commercial customer. Consequently, the sales- or usage-based royalty exception would apply. Revenue will be recognized for the commercial, sales-based milestones as the underlying sales occur. The Company exercises significant judgment when identifying distinct performance obligations within its out-license arrangements, determining the transaction price, which often includes both fixed and variable considerations, and allocating the transaction price to the proper performance obligation. The Company did not use any other significant judgments related to out-licensing revenue during the years ended December 31, 2019 and 2018. 2. Global Supply Chain Platform The Company’s Global Supply Chain Platform manufactures API for use internally in its research and development activities as well as its clinical studies, and for sale to pharmaceutical customers globally. The Company generates additional revenue on this platform, 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. 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. 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. 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. The Company also offers cash discounts, which approximate 2.3% 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. Further, the Company 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. Revenues are recorded net of provisions for variable consideration, including discounts, rebates, GPO allowances, price adjustments, returns, chargebacks, promotional programs and other sales allowances. Accruals for these provisions are presented in the consolidated financial statements as reductions in determining net sales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). As of December 31, 2019 and 2018, the Company’s total provision for chargebacks and other deductions included as a reduction of accounts receivable totaled $14.4 million and $13.1 million, respectively. The Company’s total provision for chargebacks and other revenue deductions was $87.2 million, $36.5 million, and $10.6 million for the years ended December 31, 2019, 2018, and 2017, respectively. 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 (in thousands). For the Year Ended December 31, 2019 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 17,367 $ 50,427 $ 67,794 Spain 20,000 — — 20,000 Austria — 4,422 — 4,422 India — 3,066 — 3,066 China 562 1,543 — 2,105 United Kingdom — 1,023 — 1,023 Other Foreign Countries — 2,819 — 2,819 Total Revenue $ 20,562 $ 30,240 $ 50,427 $ 101,229 For the Year Ended December 31, 2018 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 7,478 $ 30,426 $ 37,904 Spain 30,000 — — 30,000 Austria — 9,569 — 9,569 China 2,776 1,640 — 4,416 India — 3,457 — 3,457 Other Foreign Countries — 3,754 — 3,754 Total Revenue $ 32,776 $ 25,898 $ 30,426 $ 89,100 For the Year Ended December 31, 2017 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total United States $ — $ 2,715 $ 17,218 $ 19,933 India — 8,479 — 8,479 Austria — 3,962 — 3,962 China 911 1,892 — 2,803 Taiwan 500 — — 500 Other Foreign Countries — 2,366 — 2,366 Total Revenue $ 1,411 $ 19,414 $ 17,218 $ 38,043 The Company also disaggregates its revenue by product group which can be found in Note 16 – 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 (in thousands). December 31, 2019 2018 Accounts receivable, gross $ 31,207 $ 26,061 Chargebacks and other deductions (14,394 ) (13,101 ) Allowance for doubtful accounts (124 ) (9 ) Accounts receivable, net $ 16,689 $ 12,951 Deferred revenue 218 190 Total contract liabilities $ 218 $ 190 The following tables illustrate accounts receivable by reportable segments (in thousands). December 31, 2019 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total Accounts receivable, gross $ 49 $ 1,522 $ 29,636 $ 31,207 Chargebacks and other deductions — (1 ) (14,393 ) (14,394 ) Allowance for doubtful accounts — (114 ) (10 ) (124 ) Accounts receivable, net $ 49 $ 1,407 $ 15,233 $ 16,689 December 31, 2018 Oncology Innovation Platform Global Supply Chain Platform Commercial Platform Consolidated Total Accounts receivable, gross $ — $ 7,814 $ 18,247 $ 26,061 Chargebacks and other deductions — — (13,101 ) (13,101 ) Allowance for doubtful accounts — (9 ) — (9 ) Accounts receivable, net $ — $ 7,805 $ 5,146 $ 12,951 As of December 31, 2019, $0.2 million of the deferred revenue balance relates to customer deposits made by customers of the Global Supply Chain Platform and is included within accrued expenses on the consolidated balance sheet. Upon delivery of certain drug product, the Company will recognize revenue of $0.2 million. Other amounts included within the deferred revenue balance are not material to the consolidated financial statements. As of December 31, 2018, the $0.2 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 year ended December 31, 2019 There were no other material changes to contract balances during the year ended December 31, 2019. During December 2019, the Company entered into an agreement to out-license three of its proprietary products and to grant an option, excercisable by the licensee, to license two additional product canididates on separately negotiated terms, under which the Company is entitled to receive an initial payment, regulatory and commercial milestone payments, and sales-based royalty payments. The Company determined that the contract included a distinct performance obligation to deliver a license of functional IP with the regulatory data necessary for the licensee to benefit from its right to use the IP. The Company is not required to provide any additional goods or services under the agreement. The Company determined that the initial payment is fixed consideration and the regulatory and commercial milestone payments and sales-based royalty payments are variable consideration; the regulatory milestone payments will be constrained until the Company determines that it is probable that the milestones will occur. The licensed IP is considered functional and therefore, the Company will recognize revenue at a point-in-time, when such performance obligation is satisfied. Revenue from the regulatory milestones will be recognized when the constraint on the related variable consideration is alleviated. As of December 31, 2019, the Company had not yet satisfied its performance obligation to deliver the licensed IP with the necessary regulatory data and therefore, no revenue was recorded under this contract during 2019. 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 optional exemption in paragraph 606-10-50-14 and does not disclose information about remaining performance obligations related to the license of 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. |