Revenue from Contract 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. Under this method, the new guidance was applied to contracts that were not yet completed as of January 1, 2018 with the cumulative effect of initially applying the guidance recognized through accumulated deficit as the date of initial application. For contracts that were modified before the effective date, the Company reflected the aggregate effect of all modifications when identifying performance obligations and allocating transaction price, which did not have a material effect on the adjustment to accumulated deficit. 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 the "previous guidance". The adoption of ASC 606 represents a change in accounting principle that primarily impacts how revenue is recognized for the Company's drug delivery product line and how the Company accounts for contract acquisition costs such as commissions. In accordance with ASC 606, revenue is recognized when a customer obtains control of the promised products. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for these products. To achieve this core principle, the Company applies the following five steps as outlined in ASC 606: 1) Identify the contract with a customer; 2) Identify the performance obligations in the contract; 3) Determine the transaction price; 4) Allocate the transaction price to performance obligations in the contract; 5) Recognize revenue when or as the Company satisfies a performance obligation. The following table summarizes revenue from contracts with customers for the three and nine months ended September 30, 2018 and 2017: Three months Nine months (in thousands) 2018 2017 2018 2017 U.S. Omnipod $ 81,970 $ 70,065 $ 230,289 $ 195,081 International Omnipod 50,214 32,481 117,127 84,200 Drug Delivery 18,892 19,229 51,500 53,963 Total $ 151,076 $ 121,775 $ 398,916 $ 333,244 U.S. and International Omnipod The Company generates the majority of its revenue from sales of its Omnipod, which is sold in the U.S., Europe, Canada and Israel. The Omnipod is sold either directly to end users or indirectly through intermediaries, such as independent distributors who resell the Omnipod to end users or wholesalers who sell the Company's product to end users through the pharmacy channel. • Contracts with Customers. The Company's contracts with its direct customers generally consist of a physician order form, a patient information form and, if applicable, third-party insurance (payor) approval. Contracts with the Company's intermediaries are generally in the form of master service agreements against which firm purchase orders are issued. At the outset of the contract, the Company assesses the customer’s ability and intention to pay, which is based on a variety of factors including historical payment experience or, in the case of a new intermediary, published credit, credit references and other available financial information pertaining to the customer and in the case of a new direct customer, an investigation of insurance eligibility. • Performance Obligations. The performance obligations in contracts for the delivery of the Omnipod to new end users, either directly to end users or through intermediaries, primarily consist of the PDM and the initial and subsequent quantity of Pods ordered. To the extent a contract includes multiple promised items, the Company must apply judgment to determine whether promised items are capable of being distinct and distinct in the context of the contract. If these criteria are not met, the promised services are accounted for as a combined performance obligation. • Transaction Price. The price charged for the PDM and Pods is dependent on the Company's pricing as established with third party payors and intermediaries. The Company provides a right of return for sales of its Omnipod to new patients. The Company also provides for certain rebates and discounts for sales of its product through intermediaries. These rights of return, discounts and rebates represent variable consideration and reduce the transaction price at the outset of the contract based on the Company's estimates, which are primarily based on the expected value method using historical and other data related to actual product returns, discounts and rebates paid in each market in which the Omnipod is sold. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. There were no constraints recorded to variable consideration and none of the Company's contracts as of January 1, 2018 or September 30, 2018 contained a significant financing component. • Allocation of Transaction Price. The Company allocates the transaction price to each performance obligation based on its relative stand-alone selling price, which is determined based on the price at which the Company typically sells the deliverable or, if the performance obligation is not typically sold separately, the stand-alone selling price is estimated based on cost plus a reasonable profit margin or the price that a third party would charge for a similar product or service. • Recognition of Revenue. The Company transfers the Omnipod at a point in time, which is determined based on when the customer gains control of the product. Generally, intermediaries in the U.S. obtain control upon shipment based on the contractual terms including right to payment and transfer of title and risk of loss. For sales directly to end users and international intermediaries, control is generally transferred at the time of delivery based on customary business practices related to risk of ownership. Drug Delivery The Company's drug delivery product line includes sales of a modified version of the Omnipod to pharmaceutical and biotechnology companies who use the Company’s technology as a delivery method for their drugs. Under ASC 606, for the majority of this product line, revenue is recognized as the product is produced pursuant to the customer’s firm purchase commitments as the Company has an enforceable right to payment for performance completed to date and the inventory has no alternative use to the Company. Judgment is required in the assessment of progress toward completion of in-process inventory. The Company recognizes revenue over time using a blend of costs incurred to date relative to total estimated costs at completion and time incurred to date relative to total production time to measure progress toward the satisfaction of its performance obligations. The Company believes that both incurred cost and elapsed time reflect the value generated, which best depicts the transfer of control to the customer. Contract costs include third party costs as well as an allocation of manufacturing overhead. Changes from quarter to quarter in quantity and stage of production of in-process inventory could have a significant quarterly impact on revenue. 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. The following table shows the adjustments made to accounts on the consolidated balance sheet as of January 1, 2018 as a result of adopting the new guidance. The table also compares the reported consolidated balance sheet accounts as of September 30, 2018 that were impacted by the new guidance to pro forma balance sheet amounts had the previous guidance been in effect. As Reported Adjustments As Adjusted As Reported Adjustments Pro forma (in thousands) 12/31/2017 1/1/2018 1/1/2018 9/30/2018 9/30/2018 9/30/2018 Unbilled receivable (a) $ — $ 5,119 $ 5,119 $ 9,963 $ (9,963 ) $ — Inventories 33,793 (753 ) 33,040 58,050 1,430 59,480 Prepaid expenses and other current assets (b) 9,949 5,568 15,517 17,905 (6,869 ) 11,036 Total current assets 537,171 9,934 547,105 445,712 (15,402 ) 430,310 Other assets (b) 1,969 13,326 15,295 18,057 (15,567 ) 2,490 Total assets 816,744 23,260 840,004 886,306 (30,969 ) 855,337 Deferred revenue (c) 2,356 2,625 4,981 2,210 (771 ) 1,439 Total current liabilities 86,025 2,625 88,650 97,224 (771 ) 96,453 Other long-term liabilities 6,030 271 6,301 6,668 (270 ) 6,398 Total liabilities 658,228 2,896 661,124 688,377 (1,041 ) 687,336 Accumulated deficit (707,255 ) 20,349 (686,906 ) (693,507 ) (29,937 ) (723,444 ) Total stockholders' equity 158,516 20,364 178,880 197,929 (29,928 ) 168,001 Total liabilities and stockholders' equity 816,744 23,260 840,004 886,306 (30,969 ) 855,337 (a) Unbilled receivable that reflects revenue for a portion of the Company's drug delivery product line as the product is produced. The unbilled receivable is reclassified to accounts receivable as the product is completed and shipped to the customer. (b) Other current and non-current assets include contract acquisition costs related to the sale of the Omnipod. These costs are amortized over the estimated period of benefit. (c) The adoption of ASC 606 required the Company to record a contract liability, or deferred revenue, on January 1, 2018, primarily associated with a volume-based pricing discount granted to the Company's European Distributor at the outset of the distribution contract in 2010. The deferred revenue was recognized as revenue through the completion of the distributor contract during the first half of 2018. The following summarizes the significant changes on the Company’s consolidated statement of operations for the three and nine months ended September 30, 2018 as a result of the adoption of ASC 606 on January 1, 2018 compared to if the Company had continued to recognize revenue under ASC 605: Three months ended September 30, 2018 Nine months ended September 30, 2018 (in thousands, except per share amounts) As reported Adjustments Pro forma As reported Adjustments Pro forma U.S. Omnipod $ 81,970 $ (135 ) $ 81,835 $ 230,289 $ (9 ) $ 230,280 International Omnipod (a) 50,214 53 50,267 117,127 (1,845 ) 115,282 Drug Delivery (b) 18,892 3,995 22,887 51,500 (4,844 ) 46,656 Revenue 151,076 3,913 154,989 398,916 (6,698 ) 392,218 Cost of revenue 49,107 674 49,781 139,060 (677 ) 138,383 Gross profit 101,969 3,239 105,208 259,856 (6,021 ) 253,835 Sales and marketing (c) 34,922 394 35,316 102,660 3,567 106,227 Total operating expenses 95,104 394 95,498 248,666 3,567 252,233 Operating income 6,865 2,845 9,710 11,190 (9,588 ) 1,602 Income (loss) before income taxes 1,853 2,845 4,698 (5,662 ) (9,588 ) (15,250 ) Net income (loss) $ 1,659 $ 2,845 $ 4,504 $ (6,601 ) $ (9,588 ) $ (16,189 ) Net income (loss) per share: basic $ 0.03 $ 0.05 $ 0.08 $ (0.11 ) $ (0.17 ) $ (0.28 ) Net income (loss) per shares: diluted $ 0.03 $ 0.04 $ 0.07 $ (0.11 ) $ (0.17 ) $ (0.28 ) (a) International Omnipod revenue under ASC 606 includes the amortization of a material right associated with a volume-based pricing discount granted to the Company's European Distributor at the outset of the distribution contract in 2010. The deferred revenue was recognized as revenue through the completion of the distributor contract during the first half of 2018. (b) ASC 606 accelerated the recognition of revenue and fulfillment costs related to certain drug delivery contracts for which recognition was previously recorded when the product was shipped to the customer and is recorded as the product is produced under ASC 606. During the three and nine months ended September 30, 2018, revenue was lower by $4.0 million and higher by $4.8 million , respectively, due to changes in quantity and stage of production of in-process inventory relative to the prior period. (c) ASC 606 resulted in the amortization of capitalized commission costs that were recorded as part of the cumulative effect adjustment upon adoption and during the nine months ended September 30, 2018. Amortization of these capitalized costs to selling and marketing expenses, net of commission costs that were capitalized in the three and nine month periods, reduced sales and marketing expenses in each period . Nine Months Ended September 30, 2018 Statement of Cash Flows (in thousands) As Reported Adjustments Pro Forma Net loss $ (6,601 ) $ (9,588 ) $ (16,189 ) Adjustments to reconcile net loss to net cash used in operating activities Non-cash items 66,602 — 66,602 Changes in operating assets and liabilities: — Accounts receivable and unbilled receivable (24,581 ) 4,844 (19,737 ) Inventories (25,279 ) (677 ) (25,956 ) Prepaid expenses and other assets (5,258 ) 3,567 (1,691 ) Accounts payable, accrued expenses and other current liabilities 2,938 — 2,938 Deferred revenue (2,761 ) 1,854 (907 ) Other long-term liabilities 400 — 400 Net cash provided by operating activities $ 5,460 $ — $ 5,460 The adoption of ASC 606 had no net impact on the Company’s cash used in operating, investing or financing activities. Revenue recognized during the three and nine months ended September 30, 2018 from amounts included in deferred revenue at the beginning of the period was approximately $0.6 million and $2.5 million , respectively. No revenue was recognized during the three and nine months ended September 30, 2018 from performance obligations satisfied or partially satisfied in previous periods. As of September 30, 2018, unbilled receivable associated with the Company's drug delivery product line increased by $4.8 million relative to the beginning of the year due to an increase in the quantity and stage of production of in-process inventory during the year. There were no contract modifications entered into during the three and nine months ended September 30, 2018 impacting the Company’s unbilled receivable or deferred revenue. Revenue for customers comprising more than 10% of total revenue were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Amgen, Inc. 12% 16% 13% 16% Ypsomed and affiliates * 23% 11% 21% Cardinal Health Inc. and affiliates 12% 11% 12% 10% * Represents less than 10% of consolidated revenue. |