REVENUE RECOGNITION AND RELATED ALLOWANCES | 2. REVENUE RECOGNITION AND RELATED ALLOWANCES Revenue Recognition We recognize revenue using the following steps: · Identification of the contract, or contracts, with a customer; · Identification of the performance obligations in the contract; · Determination of the transaction price, including the identification and estimation of variable consideration; · Allocation of the transaction price to the performance obligations in the contract; and · Recognition of revenue when we satisfy a performance obligation. We derive our revenues primarily from sales of generic and branded pharmaceutical products. Revenue is recognized when our obligations under the terms of our contracts with customers are satisfied, which generally occurs when control of the products we sell is transferred to the customer. We estimate variable consideration after considering applicable information that is reasonably available. We generally do not have incremental costs to obtain contracts that would otherwise not have been incurred. We do not adjust revenue for the promised amount of consideration for the effects of a significant financing component because our customers generally pay us within 100 days. All revenue recognized in the accompanying unaudited interim condensed consolidated statements of operations is considered to be revenue from contracts with customers. The following table depicts the disaggregation of revenue according to contract type: Three Months Ended Nine Months Ended Products and Services September 30, September 30, September 30, September 30, (in thousands) 2019 2018 2019 2018 Sales of generic pharmaceutical products $ 31,753 $ 30,287 $ 99,452 $ 83,716 Sales of branded pharmaceutical products 16,605 14,589 48,300 41,714 Sales of contract manufactured products 2,376 2,826 8,499 5,450 Royalties from licensing agreements 268 2,409 594 12,560 Product development services 75 288 806 288 Other (1) 260 304 930 726 Total net revenues $ 51,337 $ 50,703 $ 158,581 $ 144,454 (1) Primarily includes laboratory services and royalties on sales of contract manufactured products. The following table depicts revenue recognized during the following periods: Three Months Ended Nine Months Ended Timing of Revenue Recognition September 30, September 30, September 30, September 30, (in thousands) 2019 2018 2019 2018 Performance obligations transferred at a point in time $ 51,262 $ 50,415 $ 157,775 $ 144,166 Performance obligations transferred over time 75 288 806 288 Total $ 51,337 $ 50,703 $ 158,581 $ 144,454 In the three and nine months ended September 30, 2019 and 2018, we did not incur, and therefore did not defer, any material incremental costs to obtain contracts. We recognized a decrease of $6.5 million to net revenue from performance obligations satisfied in prior periods during the nine months ended September 30, 2019, consisting primarily of revised estimates for variable consideration, including chargebacks, rebates, returns, and other allowances, related to prior period sales, partially offset by royalties from licensing agreements. We recognized $6.4 million of net revenue from performance obligations satisfied in prior periods during the nine months ended September 30, 2018, consisting primarily of royalties from licensing agreements and revised estimates for variable consideration, including chargebacks, rebates, returns, and other allowances, related to prior period sales. In August 2018, we acquired WellSpring Pharma Services Inc. (“WellSpring”) (see Note 3), a contract manufacturing company that also provides technical transfer services to customers, for which services are transferred over time. As a result, we had $0.1 million of contract assets related to revenue recognized based on a percentage of completion but not yet billed at both September 30, 2019 and December 31, 2018 and $0.5 million and $0.7 million of deferred revenue at September 30, 2019 and December 31, 2018, respectively. For the nine months ended September 30, 2019, we recognized $56 thousand of revenue that was included in deferred revenue as of December 31, 2018. Revenue from Sales of Generic and Branded Pharmaceutical Products Product sales consists of sales of our generic and brand pharmaceutical products. Our sole performance obligation in our contracts is to provide pharmaceutical products to customers. Our products are sold at pre-determined standalone selling prices and our performance obligation is considered to be satisfied when control of the product is transferred to the customer. Control is transferred to the customer upon delivery of the product to the customer, as our pharmaceutical products are sold on an FOB destination basis and because inventory risk and risk of ownership passes to the customer upon delivery. Payment terms for these sales are generally less than 100 days. Sales of our pharmaceutical products are subject to variable consideration due to chargebacks, government rebates, returns, administrative and other rebates, and cash discounts. Estimates for these elements of variable consideration require significant judgment. A comprehensive discussion of variable consideration is included in Item 8. Consolidated Financial Statements, Note 1, Description of Business and Summary of Significant Accounting Policies , in our Annual Report on Form 10‑K for the year ended December 31, 2018. The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the nine months ended September 30, 2019 and 2018, respectively: Accruals for Chargebacks, Rebates, Returns, and Other Allowances Administrative Prompt Government Fees and Other Payment (in thousands) Chargebacks Rebates Returns Rebates Discounts Balance at December 31, 2017 $ 28,230 $ 7,930 $ 8,274 $ 5,226 $ 1,834 Accruals/Adjustments 170,533 8,097 10,942 23,148 6,744 Credits Taken Against Reserve (156,750) (7,013) (8,376) (21,418) (6,373) Balance at September 30, 2018 $ 42,013 $ 9,014 $ 10,840 $ 6,956 $ 2,205 Balance at December 31, 2018 $ 39,007 $ 8,974 $ 12,552 $ 7,353 $ 2,009 Accruals/Adjustments 187,843 12,723 13,392 27,476 7,962 Credits Taken Against Reserve (188,504) (12,513) (9,999) (26,927) (7,714) Balance at September 30, 2019 $ 38,346 $ 9,184 $ 15,945 $ 7,902 $ 2,257 Contract Manufacturing Product Sales Revenue Contract manufacturing arrangements consists of agreements in which we manufacture a pharmaceutical product on behalf of third party. Our performance obligation is to manufacture and provide pharmaceutical products to customers, typically pharmaceutical companies. The contract manufactured products are sold at pre-determined standalone selling prices and our performance obligations are considered to be satisfied when control of the product is transferred to the customer. Control is transferred to the customer when the product leaves our dock to be shipped to the customer, as our pharmaceutical products are sold on an FOB shipping point basis and the inventory risk and risk of ownership passes to the customer at that time. Payment terms for these sales are generally less than two months. We estimate returns based on historical experience. Historically, we have not had material returns for contract manufactured products. As of September 30, 2019, the value of our unsatisfied performance obligations (or backlog) was $6.2 million, which consists of firm orders for contract manufactured products, for which our performance obligations remain unsatisfied and for which the related revenue has yet to be recognized. We anticipate satisfying these performance obligations within six months. Royalties from Licensing Agreements From time to time, we enter into transition agreements with the sellers of products we acquire, under which we license to the seller the right to sell the acquired products. Therefore, we recognize the revenue associated with sales of the underlying products as royalties. Because these royalties are sales-based, we recognize the revenue when the underlying sales occur, based on sales and gross profit information received from the sellers. Upon full transition of the products and upon launching the products under our own labels, we recognize revenue for the products as sales of generic or branded pharmaceutical products, as described above. We receive royalties from a license for patent rights initially owned by Cell Genesys, Inc., which merged with BioSante in 2009. The royalties are the results of sales and milestones related to the Yescarta® product. We recognize revenue for sales-based royalties when the underlying sales occur. We estimate variable consideration related to milestones, which requires significant judgment. Product Development Services Revenue We provide product development services to customers, which are performed over time. These services primarily relate to the technical transfer of product development to our facility in Oakville, Ontario. The duration of these technical transfer projects can be up to three years. Deposits received from these customers are recorded as deferred revenue until revenue is recognized. For contracts with no deposits and for the remainder of contracts with deposits, we invoice customers as our performance obligations are satisfied. We recognize revenue on a percentage of completion basis, which results in contract assets on our balance sheet. As of September 30, 2019, the value of our unsatisfied performance obligations for product development services contracts was $4.3 million. We expect to satisfy these performance obligations in the next 6 to 15 months. Credit Concentration Our customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and pharmaceutical companies. During the three months ended September 30, 2019, three customers represented 34%, 24%, and 23% of net revenues, respectively. During the nine months ended September 30, 2019, the same three customers represented 33%, 24%, and 24% of net revenues, respectively. As of September 30, 2019, accounts receivable from these customers totaled 84% of accounts receivable, net. During the three months ended September 30, 2018, three customers represented 35%, 23%, and 20% of net revenues, respectively. During the nine months ended September 30, 2018, the same three customers represented 34%, 23%, and 20% of net revenues respectively. |