Revenue from Contracts with Customers | Note 9. Revenue from Contracts with Customers Product and Product-related Services Revenue The Company had product and product-related services revenue consisting of revenue from the sale of instruments and consumables and the use of the HTG EdgeSeq proprietary technology to process samples and design custom RUO assays for the three and nine months ended September 30, 2020 and 2019 as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Product revenue: Instruments $ 71,742 $ 414,491 $ 563,396 $ 1,100,606 Consumables 764,605 1,058,386 2,091,848 2,218,674 Total product revenue 836,347 1,472,877 2,655,244 3,319,280 Product-related services revenue: Custom RUO assay design 238,502 2,129,251 1,210,968 3,978,428 RUO sample processing 626,219 708,915 1,551,519 4,100,208 Total product-related services revenue 864,721 2,838,166 2,762,487 8,078,636 Total product and product-related services revenue $ 1,701,068 $ 4,311,043 $ 5,417,731 $ 11,397,916 Because the Company’s agreements for product and product-related services revenue have an expected duration of one year or less, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations. Sale of Instruments and Consumables The delivery of each instrument and related installation and calibration are considered to be a single performance obligation, as the HTG EdgeSeq instrument must be professionally installed and calibrated prior to use. Instrument product revenue is generally recognized upon installation and calibration of the instrument by field service engineers, which represents the point at which the customer has the ability to use the instrument and has accepted the asset. Installation generally occurs within one month of instrument shipment. The delivery of each consumable is a separate performance obligation. Consumables revenue is recognized upon transfer of control, which represents the point when the customer has legal title and the significant risks of ownership of the asset. The Company’s standard terms and conditions provide that no right of return exists for instruments and consumables, unless replacement is necessary due to delivery of defective or damaged product. Customer payment terms vary but are typically between 30 and 90 days of revenue being earned from shipment or delivery, as applicable. Shipping and handling fees charged to the Company’s customers for instruments and consumables shipped are included in the accompanying condensed consolidated statements of operations as part of product and product-related services revenue. Shipping and handling costs for sold products shipped to the Company’s customers are included in the accompanying condensed consolidated statements of operations as part of cost of product and product-related services revenue. For sales of consumables in the United States, standard delivery terms are FOB shipping point, unless otherwise specified in the customer contract, reflecting transfer of control to the customer upon shipment. Standard delivery terms for sales to customers outside of the United States are FOB delivery point, unless otherwise specified in the customer contract. The Company has elected the practical expedient to account for shipping and handling as activities to fulfill the promise to transfer the consumables. The Company uses a most likely amount approach to estimate variable consideration arising from its rebate program. The Company’s variable consideration from its rebate program is constrained. The Company provides instruments to certain customers under reagent rental agreements. Under these agreements, the Company installs an instrument in the customer’s facility without a fee and the customer agrees to purchase consumable products at a stated price over the term of the agreement; in some instances, the agreements do not contain a minimum purchase requirement. Terms range from several months to multiple years and may automatically renew in several month or multiple year increments unless either party notifies the other in advance that the agreement will not renew. The Company measures progress toward complete satisfaction of this performance obligation to provide the instrument and deliver the consumables using an output method based on the number of consumables delivered in relation to the total consumables to be provided under the reagent rental agreement. This is considered to be representative of the delivery of outputs under the arrangement and the best measure of progress because the customer benefits from the instrument only in conjunction with the consumables. The Company expects to recover the cost of the instrument under the agreement through the fees charged for consumables, to the extent sold, over the term of the agreement. In reagent rental agreements, the Company retains title to the instrument and title is transferred to the customer at no additional charge at the conclusion of the initial arrangement. The cost of the instrument is amortized on a straight-line basis over the term of the arrangement, unless there is no minimum consumable product purchase, in which case the instrument would be expensed as cost of product and product-related services RUO Sample Processing The Company also provides sample preparation and processing services and molecular profiling of retrospective cohorts for its customers through its VERI/O laboratory, whereby the customer provides samples to be processed using HTG EdgeSeq technology specified in the order. Customers are charged a per sample fee for sample processing services which is recognized as revenue upon delivery of a data file to the customer showing the results of testing and completing delivery of the agreed upon service. This is when the customer can use and benefit from the results of testing and the Company has the present right to payment. Custom RUO Assay Design and Related Agreements The Company enters into custom RUO assay design agreements that may generate up-front fees and subsequent payments that might be earned upon completion of design process phases. The Company measures progress toward complete satisfaction of its performance obligation to perform custom RUO assay design using an output method based on the costs incurred to date compared with total expected costs, as this is representative of the delivery of outputs under the arrangements and the best measure of progress. However, because in most instances the assay design fees are contingent upon completion of each phase of the design project and the decision of the customer to proceed to the next phase, the amount to be included in the transaction price and recognized as revenue is limited to that which the customer is contractually obligated to pay upon completion of that phase, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company did not recognize any custom RUO assay design revenue from performance obligations that were satisfied in previous periods for either the three and nine months ended September 30, 2020, compared with $0 and $41,137 for the three and nine months ended September 30, 2019, respectively. Collaborative Development Services Revenue The Company enters into collaborative development services agreements with biopharmaceutical companies for the development of NGS-based companion diagnostic assays in support of and in conjunction with, biopharmaceutical companies’ drug development programs. These collaborative development services agreements may generate upfront fees, and in some cases subsequent milestone payments that may be earned upon completion of certain product development milestones or activities. The Company follows ASC 606, Revenue from Contracts with Customers and ASC 808, Collaborative Arrangements to determine the appropriate recognition of revenue under our collaborative research, development and commercialization agreements that contain multiple elements. For the three and nine months ended September 30, 2020 and 2019, collaborative development services revenue was generated through statements of work entered into under the Governing Agreement with QML as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Collaborative development services $ 76,030 $ 1,093,750 $ 548,135 $ 3,006,022 Master Assay Development, Commercialization and Manufacturing Agreement In November 2016, the Company entered into the Governing Agreement, which created the framework for QML and the Company to combine their technological and commercial strengths to offer biopharmaceutical companies a complete NGS-based solution for the development, manufacture and commercialization of companion diagnostic assays. Under the Governing Agreement, the parties jointly sought companion diagnostic programs with biopharmaceutical companies, with QML entering into sponsor project agreements with interested biopharmaceutical companies for specified projects, and QML and the Company entering into statements of work which set forth the rights and obligations of QML and the Company with respect to each project. In November 2019, the Company elected to terminate the Governing Agreement with QML as a result of QML’s material breach of the Governing Agreement, including QML’s failure to develop an in vitro diagnostic (“IVD”) version of its GeneReader sequencing platform for development of PDP Assays. The Company’s termination of the Governing Agreement did not terminate active statements of work under the Governing Agreement. The Company has determined that SOW Two and SOW Three (each defined below) are collaborative arrangements and that QML meets the definition of a customer under ASC 606. Additionally, each SOW is a separate contract with a single performance obligation to provide development services. Under each SOW, QML pays the Company a monthly fee for development work performed by the Company and its subcontractors (collectively, the “Monthly Fee”). The Monthly Fee is based on the employee and materials costs incurred during the month, which is subject to significant variability from period to period and unknown until the costs are incurred. Therefore, the Monthly Fee, which is based on use of hours and costs as a measure of progress, is included in the transaction price and recognized as revenue over time when the costs are incurred, and the Monthly Fee is billed to QML. It is at this time that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company and QML also share any net profits resulting from performance of the development work as determined pursuant to the Governing Agreement. Such profit-sharing payment(s) are deemed to be variable consideration using the expected value method and are included in the transaction price upon completion of the respective SOW deliverables, acceptance of corresponding deliverables, and the mutual agreement by QML and the Company on the calculation of net profit, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Because each SOW has an expected duration of one year or less, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations for each SOW. Statement of Work No. Two In October 2017, the Company and QML entered into the second statement of work under the Governing Agreement (“SOW Two”), which was made effective as of June 2, 2017 (“Onset Date”). The Company and QML amended SOW Two twice in August 2018 and two additional times, in September 2018 and in February 2019. SOW Two addresses development activities conducted by the Company and QML since the Onset Date and those expected to be further conducted by the parties in connection with what is expected to be a multi-stage project leading to the potential development and commercialization of an NGS-based companion diagnostic assay in support of one or more therapeutic development and commercialization programs for a third-party biopharmaceutical company. The initial-phase investigational-use-only (“IUO”) development activities under SOW Two and the first three amendments related to next phases, which include the use of the IUO assay developed in the initial-phase in a retrospective clinical trial and in additional disease indications, have been completed. The fourth amendment of SOW Two, effective as of February 5, 2019, contemplates the use of the IUO assay in multiple biopharmaceutical company clinical trials and additional development activities which could potentially be included in a future companion diagnostic regulatory submission. As of September 30, 2020, development activities agreed upon in the fourth amendment are ongoing and expected to be completed in the fourth quarter of 2020. Revenue of approximately $0.1 million and $0.5 million inclusive of SOW Two Monthly Fees and approximately $0.1 million and $0.1 million of SOW Two profit-sharing payments has been included in collaborative development services revenue in the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2020, respectively. Revenue of approximately $0.6 million and $2.2 million, inclusive of SOW Two Monthly Fees and approximately $0.3 million and $0.4 million of SOW Two profit-sharing payments has been included in collaborative development services revenue in the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2019, respectively. Accounts receivable relating to SOW Two of approximately $0.1 million and $0.2 million remained in the accompanying condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019, respectively. Costs relating to development activities conducted by the Company pursuant to SOW Two of less than $0.1 million and approximately $0.4 million have been included in research and development expense in the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2020, respectively, compared with approximately $0.2 million and $1.3 million for the three and nine months ended September 30, 2019, respectively. Statement of Work No. Three In January 2018, the Company and QML entered into a third statement of work under the Governing Agreement (“SOW Three”) and amended SOW Three in September 2018. SOW Three relates to development activities for an NGS-based clinical-trial assay (“SOW Three Project”) in connection with a sponsor project agreement between QML and a pharmaceutical company (“Pharma Three”). Initial assay development activities under SOW Three have been completed, and the first amendment to SOW Three provides for the development of an IUO assay, subsequent retrospective testing of clinical trial samples, design verification and, subject to satisfactory achievement of relevant performance and regulatory milestones, regulatory submissions in the United States and European Union necessary for the commercialization of a companion diagnostic for a corresponding Pharma Three drug. As of September 30, 2020, the Company and QML are on hold pending customer decision as to whether to proceed with next phase contract activities. There was no revenue recognized, or development costs incurred relating to SOW Three for the three and nine months ended September 30, 2020. Revenue of approximately $0.5 million and $0.8 million reflecting SOW Three Monthly Fees has been included in collaborative development services revenue in the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2019, respectively. Accounts receivable relating to SOW Three of $0 and approximately $0.8 million remained in the condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019, respectively. Costs relating to development activities conducted by the Company pursuant to SOW Three of approximately $0.3 million and $0.6 million have been included in research and development expense in the condensed consolidated statements of operations for the three and nine months ended September 30, 2019, respectively. Contract Assets Contract assets represent the Company's right to consideration in exchange for goods or services that the Company has transferred to a customer, for which rights to payment are conditional upon something other than the passage of time. Contract assets of approximately $42,000 and $0 were included in prepaid expenses and other in the accompanying condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019, respectively. Contract Liabilities The Company receives up-front payments from customers for custom RUO assay design services, and occasionally for sample processing services. Payments for instrument extended warranty contracts are made in advance as are payments for certain agreed-upon capital purchases required for collaborative development service projects. The Company recognizes such up-front payments as a contract liability. The contract liability is subsequently reduced at the point in time that the data file is delivered for sample processing services or as the Company satisfies its performance obligations over time for RUO assay design, collaborative development and extended warranty services. Contract liabilities of approximately $0.5 million and $0.6 million were included in contract liabilities – current and other non-current liabilities in the accompanying condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019, respectively. The Company expects approximately $0.3 million of deferred revenue to be realized within the next 12 months and the remaining $0.2 million to be realized prior to December 31, 2022. Changes in the Company’s contract liability were as follows as of the dates indicated: Product Revenue Custom RUO Assay Design Sample Processing Total Contract Liability Balance at January 1, 2020 $ 95,148 $ 66,216 $ 438,090 $ 599,454 Deferral of revenue 335,265 459,385 77,104 871,754 Recognition of deferred revenue (325,181 ) (525,601 ) (95,670 ) (946,452 ) Balance at September 30, 2020 $ 105,232 $ — $ 419,524 $ 524,756 Product Revenue Custom RUO Assay Design Sample Processing Total Contract Liability Balance at January 1, 2019 $ 116,547 $ 50,000 $ 244,400 $ 410,947 Deferral of revenue 126,425 671,885 463,814 1,262,124 Recognition of deferred revenue (172,610 ) (707,641 ) (229,192 ) (1,109,443 ) Balance at September 30, 2019 $ 70,362 $ 14,244 $ 479,022 $ 563,628 |