UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
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Securities registered pursuant to Section 12(b) of the Exchange Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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| Accelerated filer | ◻ | |
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Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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As of August 1, 2022, the registrant had
TTABLE OF CONTENTS
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Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about our financial performance, including anticipated benefits and costs associated with our plan of restructuring announced in August 2022, and are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A , “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q and in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 or other filings that we make with the Securities and Exchange Commission, or SEC. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report on Form 10-Q may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events or circumstances reflected in the forward-looking statements will be achieved or occur. You should read this Quarterly Report on Form 10-Q, and the documents that we reference herein and have filed with the SEC, with the understanding that our actual future results, levels of activity, performance, and events and circumstances may be materially different from what we expect. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to new information, actual results or to changes in our expectations, except as required by law.
Unless the context otherwise requires, the terms “Quanterix,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q refer to Quanterix Corporation and its subsidiaries. “Quanterix,” “Simoa,” “Simoa HD-X,” “Simoa HD-1,” “SR-X,” “SP-X,” “HD-X Analyzer,” “HD-1 Analyzer” and our logo are our trademarks. All other service marks, trademarks and trade names appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, these other companies.
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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
Quanterix Corporation
Condensed Consolidated Balance Sheets
(amounts in thousands, except share and per share data)
June 30, 2022 |
| December 31, 2021 | |||
Assets | |||||
Current assets: |
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Cash and cash equivalents | $ | | $ | | |
Accounts receivable (less allowance for credit losses of $ |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets | |
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Restricted cash |
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Property and equipment, net |
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Intangible assets, net |
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Goodwill |
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Right-of-use assets | | | |||
Other non-current assets |
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Total assets | $ | | $ | | |
Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable | $ | | $ | | |
Accrued compensation and benefits |
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Other accrued expenses |
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Deferred revenue |
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Short term lease liabilities | | | |||
Other current liabilities | | | |||
Total current liabilities |
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Deferred revenue, net of current portion |
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Long term lease liabilities | | | |||
Other non-current liabilities |
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Commitments and contingencies (Note 11) | |||||
Stockholders’ equity: |
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Common stock, $ |
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Authorized— |
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Additional paid-in capital |
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Accumulated other comprehensive (loss) income | ( | | |||
Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | |
See accompanying notes
4
Quanterix Corporation
Condensed Consolidated Statements of Operations
(amounts in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||
2022 |
| 2021 | 2022 |
| 2021 | ||||||
Product revenue | $ | | $ | | $ | | $ | | |||
Service and other revenue |
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Collaboration revenue |
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Grant revenue | | | | | |||||||
Total revenue |
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Costs of goods sold: |
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Cost of product revenue |
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Cost of service and other revenue |
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Total costs of goods sold and services |
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Gross profit | | | | | |||||||
Operating expenses: |
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Research and development |
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Selling, general and administrative |
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Total operating expenses |
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Loss from operations |
| ( |
| ( |
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Interest income (expense), net |
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Other (expense) income, net |
| ( |
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| ( |
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Loss before income taxes | ( | ( | ( | ( | |||||||
Income tax provision (benefit) | | | ( | ( | |||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||
Net loss per share, basic and diluted | ( | ( | ( | ( | |||||||
Weighted-average common shares outstanding, basic and diluted |
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See accompanying notes
5
Quanterix Corporation
Condensed Consolidated Statements of Comprehensive Loss
(amounts in thousands)
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2022 |
| 2021 | 2022 |
| 2021 | ||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||
Other comprehensive loss: | |||||||||||
Cumulative translation adjustment | ( | | ( | ( | |||||||
Total other comprehensive (loss) income | ( | | ( | ( | |||||||
Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( |
See accompanying notes
6
Quanterix Corporation
Condensed Consolidated Statements of Cash Flows
(amounts in thousands)
Six Months Ended June 30, | |||||
2022 |
| 2021 | |||
Operating activities |
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Net loss | $ | ( | $ | ( | |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization expense |
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Inventory step-up amortization | — | | |||
Credit loss expense on accounts receivable | | | |||
Reduction in the carrying amount of right-of-use assets | | | |||
Stock-based compensation expense |
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Non-cash interest expense |
| — |
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Loss on disposal of fixed assets | | — | |||
Changes in operating assets and liabilities: |
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Accounts receivable |
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Prepaid expenses and other assets |
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Inventory |
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Other non-current assets |
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| ( | |
Accounts payable |
| ( |
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Accrued compensation and benefits, other accrued expenses and other current liabilities |
| ( |
| ( | |
Contract acquisition costs | | ( | |||
Operating lease liabilities | ( | ( | |||
Other non-current liabilities | ( | ( | |||
Deferred revenue |
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Net cash used in operating activities | ( | ( | |||
Investing activities |
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Purchases of property and equipment |
| ( |
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Proceeds from RADx grant on assets purchased | | | |||
Net cash used in investing activities | ( | ( | |||
Financing activities |
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Proceeds from stock options exercised |
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Sale of common stock in underwritten public offering, net | — | | |||
Proceeds from ESPP purchase |
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Net cash provided by financing activities | | | |||
Net (decrease) increase in cash, cash equivalents and restricted cash |
| ( |
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Effect of foreign currency exchange rate on cash | ( | ( | |||
Cash, restricted cash, and cash equivalents at beginning of period |
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Cash, restricted cash, and cash equivalents at end of period | $ | | $ | | |
Reconciliation of cash, cash equivalents, and restricted cash: | |||||
Cash and cash equivalents | $ | | $ | | |
Restricted cash | | | |||
Total cash, cash equivalents, and restricted cash | $ | | $ | |
See accompanying notes
7
Quanterix Corporation
Condensed Consolidated Statements of Stockholders’ Equity
(amounts in thousands, except share data)
Common stock | ||||||||||||||||
Shares |
| Value |
| Additional paid-in capital |
| Accumulated other comprehensive income (loss) |
| Accumulated deficit |
| Total stockholders' equity | ||||||
Balance at March 31, 2022 | | $ | | $ | | $ | ( | $ | ( |
| $ | | ||||
Issuance of capital shares: | ||||||||||||||||
−Exercised stock options | | — | |
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−Restricted units converted | | — | — | — | ||||||||||||
−Issuance of common stock | | — | — | — | ||||||||||||
Stock-based compensation expense | | | ||||||||||||||
Cumulative translation adjustment | ( | ( | ||||||||||||||
Net loss | ( | ( | ||||||||||||||
Balance at June 30, 2022 | |
| $ | |
| $ | |
| $ | ( | $ | ( |
| $ | | |
Common stock | ||||||||||||||||
Shares |
| Value |
| Additional paid-in capital |
| Accumulated other comprehensive income (loss) |
| Accumulated deficit |
| Total stockholders' equity | ||||||
Balance at March 31, 2021 | | $ | | $ | | $ | | $ | ( |
| $ | | ||||
Issuance of capital shares: | ||||||||||||||||
−Exercised stock options | | | |
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−Restricted units converted | | — | — | — | ||||||||||||
Stock-based compensation expense | | | ||||||||||||||
Cumulative translation adjustment | | | ||||||||||||||
Net loss | ( | ( | ||||||||||||||
Balance at June 30, 2021 | |
| $ | |
| $ | |
| $ | | $ | ( |
| $ | | |
Common stock | ||||||||||||||||
Shares |
| Value |
| Additional paid-in capital |
| Accumulated other comprehensive income (loss) |
| Accumulated deficit |
| Total stockholders' equity | ||||||
Balance at December 31, 2021 | | $ | | $ | | $ | | $ | ( |
| $ | | ||||
Issuance of capital shares: | ||||||||||||||||
−Exercised stock options | | — | |
| | |||||||||||
−Restricted units converted | | — | — | — | ||||||||||||
−Issuance of common stock | | — | — | — | ||||||||||||
−ESPP stock purchase | | — | |
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Stock-based compensation expense | | | ||||||||||||||
Cumulative translation adjustment | ( | ( | ||||||||||||||
Net loss | ( | ( | ||||||||||||||
Balance at June 30, 2022 | |
| $ | |
| $ | |
| $ | ( | $ | ( |
| $ | | |
Common stock | ||||||||||||||||
Shares |
| Value |
| Additional paid-in capital |
| Accumulated other comprehensive income (loss) |
| Accumulated deficit |
| Total stockholders' equity | ||||||
Balance at December 31, 2020 | | $ | | $ | | $ | | $ | ( |
| $ | | ||||
Issuance of capital shares: | ||||||||||||||||
−Exercised warrants | | — | — | — | ||||||||||||
−Exercised stock options | | | |
| | |||||||||||
−Restricted units converted | | — | — | — | ||||||||||||
−ESPP stock purchase | | — | |
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Sale of common stock in underwritten public offering, net | | | | | ||||||||||||
Stock-based compensation expense | | | ||||||||||||||
Cumulative translation adjustment | ( | ( | ||||||||||||||
Net loss | ( | ( | ||||||||||||||
Balance at June 30, 2021 | |
| $ | |
| $ | |
| $ | | $ | ( |
| $ | |
See accompanying notes
8
Quanterix Corporation
Notes to condensed consolidated financial statements
1. Organization and operations
Quanterix Corporation (Nasdaq: QTRX) (the Company) is a life sciences company that has developed next generation, ultra-sensitive digital immunoassay platforms that advance precision health for life sciences research and diagnostics. The Company's platforms are based on its proprietary digital “Simoa” detection technology. The Company's Simoa bead-based and planar array platforms enable customers to reliably detect protein biomarkers in extremely low concentrations in blood, serum and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies, and also allow researchers to define and validate the function of novel protein biomarkers that are only present in very low concentrations. These capabilities provide the Company's customers with insight into the role of protein biomarkers in human health that has not been possible with other existing technologies and enable researchers to unlock unique insights into the continuum between health and disease. The Company is currently focusing on protein detection, which it believes is an area of significant unmet need and where it has significant competitive advantages. However, in addition to enabling new applications and insights in protein analysis, the Company’s Simoa platforms have also demonstrated applicability across other testing applications, including detection of nucleic acids and small molecules.
The Company launched its first immunoassay platform, the Simoa HD-1 (HD-1), in 2014. The HD-1 is a fully automated immunoassay bead-based platform with multiplexing and custom assay capability, and related assay test kits and consumable materials. In the fourth quarter of 2017, the Company launched a second bead-based immunoassay platform (SR-X) with a more compact footprint than the HD-1 and less automation designed for lower volume requirements while still allowing multiplexing and custom assay capability. The Company initiated an early-access program for its third instrument (SP-X) on the new Simoa planar array platform in January 2019, with the full commercial launch commencing in April 2019. In July 2019, the Company launched the Simoa HD-X, an upgraded version of the HD-1 and phased out the HD-1. The HD-X has been designed to deliver significant productivity and operational efficiency improvements, as well as greater user flexibility. The Company began shipping and installing HD-X instruments at customer locations in the third quarter of 2019. The Company also performs research services on behalf of customers to apply the Simoa technology to specific customer needs. The Company's customers are primarily in the research use only market, which includes academic and governmental research institutions, the research and development laboratories of pharmaceutical manufacturers, contract research organizations, and specialty research laboratories.
Basis of presentation
The interim condensed consolidated financial statements are unaudited. The unaudited condensed consolidated financial statements reflect, in the opinion of the Company’s management, all adjustments, consisting of only normal recurring adjustments, necessary for a fair presentation of financial position, results of operations, comprehensive loss and cash flows for each period presented and have been prepared in accordance with United States generally accepted accounting principles (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain information and disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 1, 2022.
Reclassifications
Certain amounts in the prior years’ consolidated financial statements have been reclassified to conform to the current year’s presentation.
9
2. Significant accounting policies
The significant accounting policies and estimates used in the preparation of the accompanying consolidated financial statements are described in the Company’s audited consolidated financial statements for the year ended December 31, 2021, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 1, 2022. There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2022. For a discussion of recently issued accounting standards updates, refer to Note 2 in the Company’s Annual Report on Form 10-K filed with the SEC on March 1, 2022.
3. Revenue recognition
The Company recognizes revenue when a customer obtains control of a promised good or service. The amount of revenue recognized reflects consideration that the Company expects to be entitled to receive in exchange for these goods and services, incentives and taxes collected from customers that are subsequently remitted to governmental authorities.
Customers
The Company’s customers primarily consist of entities engaged in the life sciences research market that pursue the discovery and development of new drugs for a variety of neurologic, cardiovascular, oncologic and other protein biomarkers associated with diseases. The Company’s customer base includes several of the largest biopharmaceutical companies, academic research organizations and distributors who serve certain geographic markets.
Product revenue
The Company’s products are composed of analyzer instruments, assay kits and other consumables such as reagents. Products are sold directly to biopharmaceutical and academic research organizations or are sold through distributors in EMEA and Asia Pacific regions. The sales of instruments are generally accompanied by an initial year of implied service-type warranties and may be bundled with assays and other consumables and may also include other items such as training and installation of the instrument and/or an extended service warranty. Revenues from the sale of products are recognized at a point in time when the Company transfers control of the product to the customer, which is upon installation for instruments sold to direct customers, and based upon shipping terms for assay kits and other consumables. Revenue for instruments sold to distributors is generally recognized based upon shipping terms (either upon shipment or delivery).
Service and other revenue
Service revenues are composed of contract research services, initial implied
During the first quarter of 2022, the Company entered into a Master Collaboration Agreement with Eli Lilly and Company (Lilly) establishing a framework for future projects focused on the development of Simoa immunoassays (the Lilly Collaboration Agreement). The Company also entered into a Statement of Work under the Lilly Collaboration Agreement to perform assay research and development services within the field of Alzheimer’s disease. In connection with the Lilly Collaboration Agreement, the Company received a non-refundable up-front payment of $
10
during the first quarter of 2022, and under the Statement of Work receives $
Concurrent with the execution of the Lilly Collaboration Agreement, the Company entered into a Technology License Agreement (the Lilly License) under which Lilly granted to the Company a non-exclusive license to Lilly’s proprietary P-tau217 antibody technology for potential near-term use in research use only products and services and future in vitro diagnostics applications within the field of Alzheimer’s disease. In consideration of the license, the Company paid an upfront fee, is required to make milestone payments based on the achievement of predetermined regulatory and commercial events, and will pay a royalty on net sales of licensed products.
The Company concluded that the Lilly Collaboration Agreement (including the Statement of Work) and the Lilly License represented a single contract with a customer and is accounting for the agreements as service revenue recognized over time as the services are delivered. The transaction price for the Lilly Collaboration Agreement is $
During the three and six months ended June 30, 2022, the Company recognized approximately $
Collaboration and license revenue
The Company may enter into agreements to license the intellectual property and know-how associated with its instruments and certain antibodies in exchange for license fees and future royalties (as described below). The license agreements provide the licensee with a right to use the intellectual property with the license fee revenues recognized at a point in time as the underlying license is considered functional intellectual property.
Payment terms
The Company’s payment terms vary by the type and location of the customer and the products or services offered. Payment from customers is generally required in a term ranging from
11
Disaggregated revenue
When disaggregating revenue, the Company considered all of the economic factors that may affect its revenues. The following tables disaggregate the Company's revenue from contracts with customers by revenue type (in thousands):
Three Months Ended June 30, 2022 |
| Six Months Ended June 30, 2022 | |||||||||||||||||||||
NA |
| EMEA |
| Asia Pacific |
| Total | NA |
| EMEA |
| Asia Pacific |
| Total | ||||||||||
Product revenues | |||||||||||||||||||||||
Instruments | $ | | | | $ | | $ | | $ | | $ | | $ | | |||||||||
Consumable and other products | | | | | | | | | |||||||||||||||
Total | $ | | | | $ | | $ | |
| $ | |
| $ | |
| $ | | ||||||
Service and other revenues | |||||||||||||||||||||||
Service-type warranties | $ | | $ | | $ | | $ | | $ | | $ | | $ | | $ | | |||||||
Research services | | | |
| | | | |
| | |||||||||||||
Other services | | | | | | | | | |||||||||||||||
Total | $ | | $ | | $ | | $ | | $ | | $ | | $ | | $ | | |||||||
Collaboration and license revenue | |||||||||||||||||||||||
Collaboration and license revenue | $ | | $ | | $ | — | $ | | $ | | $ | | $ | | $ | |
Three Months Ended June 30, 2021 |
| Six Months Ended June 30, 2021 | |||||||||||||||||||||
NA |
| EMEA |
| Asia Pacific |
| Total | NA |
| EMEA |
| Asia Pacific |
| Total | ||||||||||
Product revenues | |||||||||||||||||||||||
Instruments | $ | |
| $ | |
| $ | |
| $ | | $ | | $ | | $ | | $ | | ||||
Consumable and other products | |
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| |
| | | | | | ||||||||||||
Total | $ | |
| $ | |
| $ | |
| $ | | $ | |
| $ | |
| $ | |
| $ | | |
Service and other revenues | |||||||||||||||||||||||
Service-type warranties | $ | |
| $ | |
| $ | |
| $ | | $ | | $ | | $ | | $ | | ||||
Research services | |
| |
| |
| | | | |
| | |||||||||||
Other services | |
| |
| — |
| | | | — | | ||||||||||||
Total | $ | | $ | | $ | | $ | | $ | | $ | | $ | | $ | | |||||||
Collaboration and license revenue | |||||||||||||||||||||||
Collaboration and license revenue | $ | | $ | | $ | — | $ | | $ | | $ | | $ | — | $ | |
For each of the three and six months ended June 30, 2022, there was
The Company’s contracts with customers may include promises to transfer multiple products and services to a customer. The Company combines any performance obligations that are immaterial with one or more other performance obligations that are material to the contract. For arrangements with multiple performance obligations, the Company allocates the contract transaction price, including discounts, to each performance obligation based on its relative standalone selling price. Judgment is required to determine the standalone selling price for each distinct performance obligation. The Company determines standalone selling prices based on prices charged to customers in observable transactions and uses a range of amounts to estimate standalone selling prices for each performance obligation. The
12