Quanterix Corp
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
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Jun 30, 2024 · Filed Aug 8, 2024
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Notes to Consolidated Financial Statements
(unaudited)
Note 1. Organization and Nature of Business
Quanterix Corporation (“Quanterix” or the “Company”) is a life sciences company that has developed next generation, ultra-sensitive digital immunoassay platforms that advance life sciences research and diagnostics. The Company’s platforms are based on its proprietary digital “Simoa” detection technology and enable customers to reliably detect protein biomarkers in ultra-low concentrations in blood, serum, and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies. The ability of the Company’s Simoa platforms to detect proteins in the femtomolar range is enabling the development of novel therapies and diagnostics and has the potential to facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis, and, ultimately, prevention.
The Company also provides contract research services for customers and Laboratory Developed Test (“LDT”) services through its Clinical Laboratory Improvement Amendments of 1988 ("CLIA") certified Accelerator Laboratory (the “Accelerator Laboratory”). The Accelerator Laboratory provides customers with access to its Simoa technology and its Lucent Diagnostics clinical testing services (launched in July 2023) and supports multiple projects and services, including sample testing, homebrew assay development, custom assay development, and blood-based biomarker testing.
Note 2. Significant Accounting Policies
Basis of Presentation
The accompanying Consolidated Financial Statements and Notes to Consolidated Financial Statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”) regarding interim financial reporting on Form 10-Q. Accordingly, certain information and disclosures required for complete financial statements prepared in accordance with U.S. GAAP are not included herein. The Consolidated Balance Sheet and related information as of December 31, 2023 included herein was derived from the audited Consolidated Financial Statements as of December 31, 2023, but does not include all disclosures required by U.S. GAAP on an annual reporting basis. Certain amounts in the prior years’ Consolidated Financial Statements have been reclassified to conform to the current year’s presentation.
These Consolidated Financial Statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on February 29, 2024. Since the date of that filing, there have been no changes or updates to the Company’s significant accounting policies, other than those described below.
In the opinion of management, the Consolidated Financial Statements and Notes to Consolidated Financial Statements contain all normal, recurring adjustments necessary for a fair statement of financial position, results of operations, comprehensive loss, and cash flows as of the dates and for the interim periods presented. The results of operations for the three and six months ended June 30, 2024 may not be indicative of the results for the full year ended December 31, 2024, or any other period.
The Company’s fiscal year is the 12-month period from January 1 through December 31, and all references to “2024,” “2023,” and the like refer to the fiscal year unless otherwise noted.
Use of Estimates
The preparation of the Consolidated Financial Statements and Notes to Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the end of each fiscal period, and the reported amounts of revenues and expenses during each fiscal period. Such estimates include, but are not limited to, revenue recognition, valuation of inventory, leases, valuation and impairment of intangible and long-lived assets, recoverability of deferred tax assets, and stock-based compensation expense. The Company bases its estimates on historical experience, known trends, worldwide economic conditions, both general and specific to the life sciences industry, and other relevant factors it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates and changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.
Principles of Consolidation
The Consolidated Financial Statements and Notes to Consolidated Financial Statements include the accounts of Quanterix and its wholly-owned subsidiaries. All intercompany transactions have been eliminated in consolidation.
In accordance with Accounting Standards Codification (“ASC”) 810 –Consolidation, the Company assesses the terms of non-marketable equity investments in entities to determine if any meet the definition of a variable interest entity (“VIE”) and require consolidation into its Consolidated Financial Statements. Refer to Note 14 - Variable Interest Entities for further discussion.
Foreign Currency
The functional currency of the Company’s subsidiaries is their respective local currencies. These subsidiary financial statements are translated into U.S. dollars using the period-end exchange rates for assets and liabilities, average exchange rates during the corresponding period for revenue and expenses, and historical rates for equity. The effects of foreign currency translation adjustments are recorded in accumulated other comprehensive income (loss), a component of stockholders’ equity on the Consolidated Balance Sheets.
Foreign currency transaction gains (losses) are included in other income (expense), net on the Consolidated Statements of Operations and were not material for the three months ended June 30, 2024 and 2023. Foreign currency transaction losses were $0.3 million for the six months ended June 30, 2024 and were not material for the six months ended June 30, 2023.
Restricted Cash
The following table summarizes the period ending cash and cash equivalents as presented on the Consolidated Balance Sheets and the total cash, cash equivalents, and restricted cash as presented on the Consolidated Statements of Cash Flows (in thousands):
| As of June 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash and cash equivalents | $47,002 | $329,525 |
| Restricted cash | 2,607 | 2,686 |
| Cash, cash equivalents, and restricted cash | $49,609 | $332,211 |
Restricted cash consists of collateral for a letter of credit issued as security for two of the Company’s leased facilities and to secure the Company’s corporate credit card program. The short-term or long-term classification is determined in accordance with the expiration of the underlying letter of credit and security.
Recently Adopted Accounting Pronouncements
In June 2022, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ASU 2022-03”). This update clarifies the guidance in Topic 820 related to measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, as well as introduces new disclosure requirements for these types of equity securities. The new standard became effective for the Company on January 1, 2024. The Company adopted this standard on a prospective basis and such adoption did not have a material impact on the Company’s Consolidated Financial Statements or related disclosures.
Recent Accounting Standards to be Adopted
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The new standard enhances the disclosures of reportable segment information, primarily with regards to significant segment expenses, and applies to entities with a single reportable segment. The new standard is effective for the Company for annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. Upon adoption, the guidance should be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact of adoption of the standard on its Consolidated Financial Statements disclosures.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The new standard enhances income tax disclosure requirements by requiring specified categories and greater disaggregation within the tax rate reconciliation table, disclosure of income taxes paid by jurisdiction, and providing clarification on uncertain tax positions and related financial statement impacts. The new standard is effective for the Company for annual periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the impact of adoption of the standard on its Consolidated Financial Statements disclosures.
Note 3. Revenue and Related Matters
Revenue from Contracts with Customers
The Company’s customers primarily consist of entities engaged in life sciences research that pursue the discovery and development of new drugs for a variety of neurologic, oncologic, cardiovascular, and infectious diseases, and other protein biomarkers associated with diseases. The Company’s customer base includes pharmaceutical, biotechnology, contract research organizations, academic, and government institutions.
Disaggregated Revenue
The following table disaggregates the Company’s revenue from contracts with customers by geography, based on the location products and services are consumed, and revenue type (in thousands):
| Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | |||||||
|---|---|---|---|---|---|---|---|---|
| North America | EMEA | Asia Pacific | Total | North America | EMEA | Asia Pacific | Total | |
| Product revenue: | ||||||||
| Instruments | $1,580 | $557 | $329 | $2,466 | $1,042 | $971 | $1,473 | $3,486 |
| Consumable and other products | 10,498 | 5,096 | 1,827 | 17,421 | 9,811 | 4,547 | 1,848 | 16,206 |
| Total | $12,078 | $5,653 | $2,156 | $19,887 | $10,853 | $5,518 | $3,321 | $19,692 |
| Service revenue: | ||||||||
| Service-type warranties | $1,611 | $902 | $200 | $2,713 | $1,559 | $753 | $153 | $2,465 |
| Research services | 7,775 | 2,183 | 170 | 10,128 | 6,321 | 711 | 453 | 7,485 |
| Other services | 429 | 240 | 1 | 670 | 372 | 219 | 11 | 602 |
| Total | $9,815 | $3,325 | $371 | $13,511 | $8,252 | $1,683 | $617 | $10,552 |
| Collaboration and license revenue: | ||||||||
| Total | $729 | $— | $— | $729 | $629 | $— | $— | $629 |
| Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | |||||||
|---|---|---|---|---|---|---|---|---|
| North America | EMEA | Asia Pacific | Total | North America | EMEA | Asia Pacific | Total | |
| Product revenue: | ||||||||
| Instruments | $1,988 | $1,826 | $1,198 | $5,012 | $3,186 | $2,962 | $2,597 | $8,745 |
| Consumable and other products | 20,740 | 9,137 | 4,668 | 34,545 | 17,268 | 9,556 | 3,410 | 30,234 |
| Total | $22,728 | $10,963 | $5,866 | $39,557 | $20,454 | $12,518 | $6,007 | $38,979 |
| Service revenue: | ||||||||
| Service-type warranties | $3,248 | $1,754 | $394 | $5,396 | $3,116 | $1,459 | $288 | $4,863 |
| Research services | 13,537 | 4,985 | 297 | 18,819 | 11,510 | 945 | 568 | 13,023 |
| Other services | 747 | 488 | 28 | 1,263 | 754 | 476 | 15 | 1,245 |
| Total | $17,532 | $7,227 | $719 | $25,478 | $15,380 | $2,880 | $871 | $19,131 |
| Collaboration and license revenue: | ||||||||
| Total | $796 | $88 | $— | $884 | $997 | $— | $— | $997 |
For the three and six months ended June 30, 2024, no customer accounted for more than 10% of the Company’s total revenues and for the three and six months ended June 30, 2023, one customer accounted for more than 10% of the Company’s total revenues. At June 30, 2024 and December 31, 2023, one customer accounted for more than 10% of the Company’s gross accounts receivable.
Product Revenue
UltraDx
On May 26, 2022, the Company and UltraDx Limited (“UltraDx”), a company formed by ARCH Venture Partners (“ARCH”), entered into an agreement (the “UltraDx Agreement"). Under the UltraDx Agreement, the Company agreed to supply UltraDx with HD-X instruments (both fully assembled and disassembled), assays and assay components, and granted a co-exclusive license to manufacture, seek Chinese regulatory approval of (including performance of any necessary research and development activities), and commercialize HD-X instruments assembled in China and related assays in the Chinese neurological in vitro diagnostic market. Refer to Note 13 - Related Party Transactions for a discussion of the related party relationships between Quanterix and these entities.
The consideration due to the Company included cash proceeds and contingent, non-cash consideration in the form of ordinary shares of UltraDx with a deemed fair value of $1.0 million. The issuance of the ordinary shares was contingent on UltraDx completing a preferred share financing under the terms and conditions in the UltraDx Agreement. Given the uncertainty of the completion of a preferred share financing, the Company concluded that the non-cash consideration related to the ordinary shares was variable consideration that was fully constrained at contract inception.
In the second quarter of 2023, UltraDx completed a qualified preferred share financing and issued to the Companyone million ordinary shares. Refer to Note 6 - Fair Value of Financial Instruments for the Company’s fair value disclosures related to the ordinary shares received and Note 14 - Variable Interest Entities for the Company's evaluation of its investments in other entities under the VIE guidance.
During the three and six months ended June 30, 2024, revenue recognized from the UltraDx Agreement was not material and $1.1 million, respectively. During both the three and six months ended June 30, 2023, the Company recognized $1.4 million of revenue, which includes the one-time revenue from the receipt of the ordinary shares.
Service Revenue
Eli Lilly and Company Service Revenue Agreements
On February 25, 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 an initial statement of work (the "SOW") under the Lilly Collaboration Agreement to perform assay research and development services within the field of Alzheimer’s disease ("AD"). Under the SOW, the Company receives $1.5 million per calendar quarter, which began in the first quarter of 2022. The initial SOW automatically renews on a quarterly basis until Lilly provides a termination notice in accordance with the terms of the Lilly Collaboration Agreement.
During the second quarter of 2024, Lilly launched its CertuitAD test. As a result, on May 14, 2024, Lilly provided notice to terminate the SOW, effective August 22, 2024. Under the terms of the SOW, the Company received a quarterly payment of $1.5 million during the second quarter of 2024 and will receive a final quarterly payment of $1.5 million in the third quarter of 2024. The Lilly Collaboration Agreement remains in effect and the Company continues to provide products and services to Lilly under other contractual arrangements.
Concurrent with the execution of the Lilly Collaboration Agreement, the Company entered into a Technology License Agreement (the “Lilly License”) under which Lilly granted a non-exclusive license to Lilly’s proprietary p-Tau 217 antibody technology for use by the Company in research use only products, services, and future in vitro diagnostics (“IVD”) applications within the field of Alzheimer’s disease. In consideration of the Lilly 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 royalties on net sales of licensed products.
The Company recognized revenue from the Lilly Collaboration Agreement of $1.5 million and $3.0 million during the three and six months ended June 30, 2024 and 2023, respectively.
Contract Assets
There wereno contract assets as of June 30, 2024 or December 31, 2023.
Deferred Revenue
During the six months ended June 30, 2024 and 2023, the Company recognized $4.9 million of revenue in each of the respective periods related to its deferred revenue balance at January 1 of each such period.
Remaining Performance Obligations
As of June 30, 2024, the aggregate amount of transaction prices allocated to performance obligations that were not yet satisfied, or were partially satisfied, was $11.0 million. Of this amount, $10.1 million is expected to be recognized as revenue in the next 12 months, with the remainder expected to be recognized thereafter. The $11.0 million primarily consists of amounts billed for undelivered services related to initial and extended service-type warranties and research services.
Costs to Obtain a Contract
Changes in costs to obtain a contract were as follows (in thousands):
| 2024 | 2023 | |
|---|---|---|
| Balance at December 31 of prior year | $289 | $377 |
| Capitalization of costs to obtain a contract | 174 | 335 |
| Recognition of costs to obtain a contract | (183) | (333) |
| Balance at June 30 | $280 | $379 |
The Company evaluates potential impairment of these amounts at each balance sheet date, andno related impairments were recorded during thesix months ended June 30, 2024 and 2023.
Grant Revenue
All of the Company's grant revenue is generated within North America.
NIH Grant
On September 21, 2022, the Company and the National Institutes of Health (the “NIH”), an agency of the U.S. Department of Health and Human Services, entered into a contract (the “NIH Grant”) with a total award value of $1.7 million. The NIH granted the Company funding in support of the development of certain point-of-care diagnostic technologies through collaborative efforts. Grant funding is to be used solely for activities related to the point-of-care diagnostic device development project and the contract period runs through August 2025. Receipt of the award value occurs throughout the term of the contract period and after the Company submits for reimbursement of activities related to the grant. As of June 30, 2024, the Company had received $0.8 million of the total award value.
During thethree and six months ended June 30, 2024, grant revenue recognized and research and development expenses incurred were not material and $0.4 million, respectively. During thethree and six months ended June 30,2023, grant revenue recognized and research and development expenses incurred werenot material.
ADDF Grant
On March 24, 2022, the Company and the Alzheimer’s Drug Discovery Foundation (the “ADDF”) entered into a contract (the “ADDF Grant”) with a total funding value of $2.3 million. The ADDF is a charitable venture philanthropy entity that granted the Company funding in support of certain activities for the development of an IVD test for early detection of AD. The ADDF Grant restricts the Company’s use of the granted funds solely for activities related to the Company’s Alzheimer’s diagnostic test development project and the contract period runs through December 2024. Receipt of the contract funding was subject to achievement of pre-defined milestones, and as of December 31, 2023, the Company had received the total funding value of $2.3 million.
During the three and six months ended June 30, 2024 and 2023 grant revenue recognized and research and development expenses incurred were not material. As of June 30, 2024, the Company had $0.9 million of deferred revenue related to the ADDF Grant.
Note 4. Allowance for Credit Losses
The change in the allowance for expected credit losses on accounts receivable is summarized as follows (in thousands):
| 2024 | 2023 | |
|---|---|---|
| Balance at December 31 of prior year | $454 | $118 |
| Provision for expected credit losses | 676 | 516 |
| Write-offs and recoveries collected | (118) | (192) |
| Balance at June 30 | $1,012 | $442 |
Note 5. Marketable Securities
The amortized cost, gross unrealized gains, gross unrealized losses, and fair value of the Company’s marketable securities by major security type were as follows (in thousands):
| As of June 30, 2024 | |||||
|---|---|---|---|---|---|
| Amortized Cost · Unrealized Gains · Unrealized Losses · Fair Value | |||||
| Commercial paper | $30,297 | $— | $(31) | $30,266 | |
| U.S. Treasuries | 61,418 | — | (29) | 61,389 | |
| U.S. Government agency bonds | 78,455 | 1 | (179) | 78,277 | |
| Corporate bonds | 87,908 | 14 | (234) | 87,688 | |
| Total marketable securities | $258,078 | $15 | $(473) | $257,620 | |
| Marketable securities are recorded in the following Consolidated Balance Sheets captions: | |||||
| Cash and cash equivalents | $7,767 | ||||
| Marketable securities | 249,853 | ||||
| Total marketable securities | $257,620 | ||||
| As of December 31, 2023 | ||||
|---|---|---|---|---|
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
| Commercial paper | $53,482 | $23 | $(12) | $53,493 |
| U.S. Treasuries | 4,896 | 1 | — | 4,897 |
| U.S. Government agency bonds | 28,366 | 39 | (7) | 28,398 |
| Corporate bonds | 66,726 | 289 | (8) | 67,007 |
| Total marketable securities | $153,470 | $352 | $(27) | $153,795 |
| Marketable securities are recorded in the following Consolidated Balance Sheets captions: | ||||
| Cash and cash equivalents | $6,893 | |||
| Marketable securities | 146,902 | |||
| Total marketable securities | $153,795 | |||
The following tables show the fair value and gross unrealized losses of the Company’s available-for-sale securities, with unrealized losses that are not deemed to be other-than-temporary aggregated by major security type and length of time that the individual securities have been in a continuous unrealized loss position (in thousands):
| Less Than 12 Months | ||
|---|---|---|
| As of June 30, 2024 | Fair Value | Unrealized Losses |
| Commercial paper | $30,266 | $(31) |
| U.S. Treasuries | 61,389 | (29) |
| U.S. Government agency bonds | 74,306 | (179) |
| Corporate bonds | 79,529 | (234) |
| Total | $245,490 | $(473) |
| Less Than 12 Months | ||
|---|---|---|
| As of December 31, 2023 | Fair Value | Unrealized Losses |
| Commercial paper | $32,137 | $(12) |
| U.S. Government agency bonds | 15,861 | (7) |
| Corporate bonds | 8,367 | (8) |
| Total | $56,365 | $(27) |
The Company did not have any individual securities in a continuous loss position for greater than 12 months, and there were no individual securities that were in a significant unrealized loss position as of June 30, 2024. For marketable securities in an unrealized loss position, the Company does not intend to sell them, it is not more likely than not that the Company will be required to sell them before recovery of their amortized cost bases, and the unrealized losses are not credit related. Accordingly, the Company has not recorded any impairment losses or a credit loss allowance.
The Company did not sell any marketable securities or record any realized gains or losses for the six months ended June 30, 2024. At June 30, 2024 and December 31, 2023, the Company had $1.5 million and $1.0 million, respectively, of accrued interest receivable on its marketable securities.
The following table summarizes the contractual maturities of the Company’s marketable securities (in thousands):
| As of June 30, 2024 | As of December 31, 2023 | |||
|---|---|---|---|---|
| Amortized Cost | Fair Value | Amortized Cost | Fair Value | |
| Due within one year | $213,631 | $213,306 | $95,188 | $95,232 |
| Due in one to two years | 44,447 | 44,314 | 58,282 | 58,563 |
| Total | $258,078 | $257,620 | $153,470 | $153,795 |
Note 6. Fair Value of Financial Instruments
Recurring Fair Value Measurements
The following tables present the Company’s fair value hierarchy for its financial assets that are measured at fair value on a recurring basis (in thousands):
| As of June 30, 2024 | Total | Quoted prices in active markets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) |
|---|---|---|---|---|
| Financial assets: | ||||
| Cash equivalents: (1) | ||||
| Money market funds | $23,991 | $23,991 | $— | $— |
| Commercial paper | 1,994 | — | 1,994 | — |
| U.S. Treasuries | 5,773 | — | 5,773 | — |
| Total cash equivalents | 31,758 | 23,991 | 7,767 | — |
| Marketable securities: | ||||
| Commercial paper | 28,271 | — | 28,271 | — |
| U.S. Treasuries | 55,616 | — | 55,616 | — |
| U.S. Government agency bonds | 78,277 | — | 78,277 | — |
| Corporate bonds | 87,689 | — | 87,689 | — |
| Total marketable securities | 249,853 | — | 249,853 | — |
| Total financial assets | $281,611 | $23,991 | $257,620 | $— |
| As of December 31, 2023 | Total | Quoted prices in active markets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) |
|---|---|---|---|---|
| Financial assets: | ||||
| Cash equivalents: (1) | ||||
| Money market funds | $155,367 | $155,367 | $— | $— |
| Commercial paper | 1,996 | — | 1,996 | — |
| U.S. Treasuries | 4,897 | — | 4,897 | — |
| Total cash equivalents | 162,260 | 155,367 | 6,893 | — |
| Marketable securities: | ||||
| Commercial paper | 51,498 | — | 51,498 | — |
| U.S. Government agency bonds | 28,398 | — | 28,398 | — |
| Corporate bonds | 67,006 | — | 67,006 | — |
| Total marketable securities | 146,902 | — | 146,902 | — |
| Total financial assets | $309,162 | $155,367 | $153,795 | $— |
(1)Included in cash and cash equivalents on the Consolidated Balance Sheets.
Cash equivalents and marketable securities classified as Level 2 financial assets are initially valued at their purchase price and subsequently valued at the end of each reporting period utilizing third party pricing services or other observable data. The pricing services utilize industry standard valuation methods, including both income and market-based approaches, and observable market inputs to determine the fair value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates, and other industry and economic events.
Nonrecurring Fair Value Measurements
In the second quarter of 2023, the Company received 1 million ordinary shares of UltraDx under the UltraDx Agreement (refer to Note 3 - Revenue and Related Matters). As UltraDx is a privately held entity, there is minimal market activity or other financial information available to determine the fair value of UltraDx’s shares and therefore this investment is considered a Level 3 financial asset.
Pursuant to ASC 321 –Investments – Equity Securities, the Company uses the measurement alternative for equity investments without readily determinable fair values and recognizes its equity investment in UltraDx at cost, less any impairment, and adjusted for any observable price changes in orderly transactions. The ordinary shares received were valued at $1.0 million upon receipt, primarily using the third-party purchase price of similar interests issued during UltraDx’s financing that closed in the second quarter of 2023. Changes in the inputs and assumptions used would have resulted in a higher or lower fair value measurement.
The Company’s non-marketable equity investment in UltraDx contains certain restrictions related to the sale or transfer of the securities. The restrictions are in place indefinitely and cannot lapse. No adjustment to the fair value was required as a result of adopting ASU 2022-03 on January 1, 2024.
During the three and six months ended June 30, 2024 and 2023, the Company did not record any fair value adjustments to its non-marketable equity investment, and to date, the cumulative fair value adjustments have not been material. As of June 30, 2024 and December 31, 2023, the carrying value of the non-marketable equity investment was $0.8 million, and is recorded in other non-current assets on the Consolidated Balance Sheets. Refer to Note 14 - Variable Interest Entities for the Company's evaluation of its investments in other entities under the VIE guidance.
Other Fair Value Disclosures
During the three months ended June 30, 2024 and 2023, the Company did not transfer financial assets between levels of the fair value hierarchy. Additionally, there have been no changes to the valuation techniques for Level 2 or Level 3 financial assets.
Note 7. Inventory
Inventory, net of inventory reserves, consisted of the following (in thousands):
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Raw materials | $7,649 | $5,114 |
| Work in process | 7,083 | 4,466 |
| Finished goods | 13,631 | 12,785 |
| Total inventory | $28,363 | $22,365 |
Note 8. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Accrued professional services | $1,790 | $1,596 |
| Accrued royalties | 1,387 | 1,689 |
| Accrued tax liabilities | 768 | 808 |
| Other accrued expenses | 2,632 | 1,948 |
| Total accrued expenses and other current liabilities | $6,577 | $6,041 |
Note 9. Stock-Based Compensation
Stock Options
Stock option activity for the six months ended June 30, 2024 is presented below (in thousands, except per share and contractual life amounts):
| Number of options | Weighted-averageexercise price per share | Weighted-averageremaining contractuallife (in years) | Aggregateintrinsic value | |
|---|---|---|---|---|
| Outstanding at December 31, 2023 | 2,774 | $19.62 | 7.9 | $26,941 |
| Granted | 1,315 | 22.12 | ||
| Exercised | (138) | 12.04 | ||
| Forfeited/expired | (333) | 21.53 | ||
| Outstanding at June 30, 2024 | 3,618 | $20.64 | 8.1 | $2,177 |
| Exercisable at June 30, 2024 | 1,305 | $21.79 | 6.4 | $1,292 |
| Vested and expected to vest at June 30, 2024 | 3,618 | $20.64 | 8.1 | $2,177 |
Restricted Stock Units
Restricted stock unit (“RSU”) activity for the six months ended June 30, 2024 is presented below (in thousands, except per share amounts):
| Number of shares | Weighted-averagegrant date fairvalue per share | |
|---|---|---|
| Unvested at December 31, 2023 | 1,328 | $17.87 |
| Granted | 498 | 23.61 |
| Vested | (311) | 18.86 |
| Forfeited | (157) | 19.31 |
| Unvested at June 30, 2024 | 1,358 | $19.75 |
Employee Stock Purchase Plan (“ESPP”)
In December 2017, the Company adopted the 2017 Employee Stock Purchase Plan (the “2017 ESPP”). The 2017 ESPP provides for six-month offering periods commencing and ending as follows: March 1 through August 31, and September 1 through February 28. During the six months ended June 30, 2024, employees purchased 36 thousand shares of the Company’s common stock pursuant to the 2017 ESPP.
Stock-Based Compensation Expense
Stock-based compensation expense was recorded in the following categories on the Consolidated Statements of Operations (in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Cost of product revenue | $325 | $200 | $606 | $387 |
| Cost of service and other revenue | 275 | 258 | 583 | 608 |
| Research and development | 525 | 405 | 1,068 | 775 |
| Selling, general and administrative | 4,103 | 3,330 | 8,236 | 6,325 |
| Total stock-based compensation expense | $5,228 | $4,193 | $10,493 | $8,095 |
As of June 30, 2024, there was $48.5 million of total unrecognized stock-based compensation expense related to unvested RSUs and stock options, which is expected to be recognized over the remaining weighted-average vesting period of 2.8 years.
Note 10. Net Loss Per Share
The following table presents the computation of basic and diluted net loss per share (in thousands, except per share data):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Numerator: | ||||
| Net loss | $(9,473) | $(6,064) | $(19,545) | $(12,167) |
| Denominator: | ||||
| Weighted average common shares outstanding, basic and diluted | 38,338 | 37,494 | 38,232 | 37,411 |
| Net loss per share, basic and diluted | $(0.25) | $(0.16) | $(0.51) | $(0.33) |
As the Company was in a net loss position for all periods listed in the table below, the following common share equivalents (calculated on a weighted average basis) were excluded from the calculation of diluted net loss per share (in thousands) for the three and six months ended June 30, 2024 and 2023:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Stock options | 3,660 | 2,891 | 3,590 | 2,810 |
| RSUs | 1,410 | 1,607 | 1,332 | 1,557 |
| Estimated ESPP purchases | 18 | 13 | 15 | 15 |
| Total dilutive shares | 5,088 | 4,511 | 4,937 | 4,382 |
Note 11. Income Taxes
The Company’s effective tax rates were (0.4)% and (1.5)% for the three and six months ended June 30, 2024, and (4.0)% and (3.2)% for the three and six months ended June 30, 2023, respectively. The income tax provision and effective tax rate is driven primarily by a valuation allowance in the United States, partially offset by income taxes in foreign jurisdictions.
The Company maintains a valuation allowance on the majority of its deferred tax assets, and it has concluded that it is more likely than not that the deferred assets will not be utilized.
Note 12. Commitments and Contingencies
Purchase Commitments
STRATEC
During 2022, the Company and STRATEC Consumables GmbH (“STRATEC”) entered into an amendment to the supply agreement with STRATEC (as amended, the “STRATEC Supply Agreement”), related to the supply of discs used in Simoa bead-based instruments. As part of the STRATEC Supply Agreement, the Company agreed to purchase a total of 515 thousand discs to be shipped at various points starting in 2022 and continuing through 2024 at an agreed purchase price per disc.
The total purchase commitment under the STRATEC Supply Agreement is $3.7 million, of which $2.7 million has been paid, and $1.0 million is due within one year from June 30, 2024.
During the three and six months ended June 30, 2024 STRATEC shipped 46 thousand and 81 thousand discs, respectively, and during the three and six months ended June 30, 2023 it shipped 46 thousand and 120 thousand discs, respectively, to the Company. The Company recorded cost of product revenue related to these shipments of $0.3 million and $0.6 million for the three and six months ended June 30, 2024, respectively, and $0.3 million and $0.9 million for the three and six months ended June 30, 2023, respectively. During the remainder of 2024, STRATEC is required to ship 141 thousand discs to the Company.
Other Purchase Commitments
The Company’s other non-cancellable purchase commitments primarily consist of purchases of raw materials for manufacturing operations under annual and multi-year agreements, some of which have minimum quantity requirements. As of June 30, 2024, the Company’s total purchase commitments under these agreements were $7.3 million, most of which the Company expects to incur by the end of 2025.
License Agreements
Harvard University
In August 2022, the Company and Harvard University (“Harvard”) entered into an exclusive license agreement (the “Harvard License Agreement”) for certain intellectual property owned by Harvard. Pursuant to the Harvard License Agreement, the Company paid an upfront fee of $0.6 million, which was recorded in research and development expenses on the Consolidated Statements of Operations. Under the Harvard License Agreement, the Company is required to pay Harvard low single-digit royalties on net sales of products and services using the licensed technology, as well as a portion of its applicable sublicense revenues. The Company incurredno royalty expense under the Harvard License Agreement for the three and six months ended June 30, 2024 and 2023.
Refer to Note 13 - Related Party Transactions for a discussion of a related party relationship with Harvard.
Tufts University
In June 2007, the Company and Tufts University (“Tufts”) entered into a license agreement (the “Tufts License Agreement”) for certain intellectual property owned by Tufts. The Tufts License Agreement, which was subsequently amended, is exclusive and sub-licensable, and will continue in effect on a country-by-country basis as long as there is a valid claim of a licensed patent in a country. The Company is required to pay license and maintenance fees that are creditable against royalties, in addition to low single-digit royalties on direct sales and services, and a royalty on sublicense income. The Company incurred royalty expenses related to the Tufts License Agreement of $0.6 million and $1.1 million during the three and six months ended June 30, 2024, respectively, and $0.4 million and $0.8 million during the three and six months ended June 30, 2023, respectively, which were recorded in cost of product revenue on the Consolidated Statements of Operations.
Refer to Note 13 - Related Party Transactions for a discussion of a related party relationship with Tufts.
Legal Contingencies
The Company is subject to claims in the ordinary course of business; however, the Company is not currently a party to any pending or threatened litigation, the outcome of which would be expected to have a material adverse effect on its financial condition or results of operations.
Leases
The undiscounted future lease payments for non-cancelable operating leases were as follows (in thousands):
| Maturity of lease liabilities | As of June 30, 2024 |
|---|---|
| 2024 (remainder) | $3,602 |
| 2025 | 7,296 |
| 2026 | 7,450 |
| 2027 | 7,684 |
| 2028 | 7,923 |
| 2029 | 8,143 |
| Thereafter | 7,613 |
| Total lease payments | 49,711 |
| Less: imputed interest | 10,135 |
| Total operating lease liabilities | $39,576 |
The Company’s lease agreement for office and laboratory facilities in Bedford, Massachusetts included a tenant improvement allowance with the landlord that offset a portion of the Company’s construction costs. During the first quarter of 2023, the Company received the final tenant improvement allowance reimbursement of $0.9 million.
Note 13. Related Party Transactions
In June 2007, the Company entered into the Tufts License Agreement for certain intellectual property owned by Tufts (refer to Note 12 - Commitments and Contingencies). A member of the Company’s Board of Directors was previously affiliated with Tufts and continues to receive compensation from Tufts on a formulaic basis based on royalties and license payments the Company makes to Tufts. At June 30, 2024 and December 31, 2023, open payable balances to Tufts were not material.
In August 2022, the Company entered into the Harvard License Agreement for certain intellectual property owned by Harvard (refer to Note 12 - Commitments and Contingencies). Harvard is required to pay a portion of the payments received from the Company under the Harvard License Agreement to a member of the Company’s Board of Directors. The same member of the Company’s Board of Directors is also affiliated with Mass General Brigham. Revenue recorded from sales of products and services to Harvard and Mass General Brigham was not material and $0.5 million for the three and six months ended June 30, 2024, respectively, and $0.5 million and $0.7 million for the three and six months ended June 30, 2023, respectively. Cost of product revenue and operating expenses with Harvard and Mass General Brigham were not material for the three and six months ended June 30, 2024 and 2023. At June 30, 2024 and December 31, 2023, open payables to and receivable balances from Harvard and Mass General Brigham were not material.
As discussed in Note 3 - Revenue and Related Matters, on May 26, 2022, the Company and UltraDx, a company formed by ARCH, entered into the UltraDx Agreement. At contract inception, the Company determined that UltraDx was a related party because a member of the Company’s Board of Directors was affiliated with ARCH and UltraDx. As of June 7, 2023, this individual no longer served as a member of the Company’s Board of Directors. Cost of goods sold were not material for the three and six months ended June 30, 2024 and 2023. At June 30, 2024 and December 31, 2023 open receivable balances from UltraDx were not material and there wereno open payable balances to UltraDx.
Note 14. Variable Interest Entities
The Company enters into relationships with, or has investments in, other entities that may be VIEs. The Company assesses the criteria in ASC 810 –Consolidation to determine if any such entities meet the definition of a VIE and require consolidation into its financial statements. Based on the Company’s assessments, it does not have any controlling financial interests in any VIE, and therefore did not consolidate any VIE into its Consolidated Financial Statements during the three and six months ended June 30, 2024 and 2023.
As of June 30, 2024 and December 31, 2023, the carrying value of the Company’s investments in VIEs was$0.8 million, which was recorded in other non-current assets on the Consolidated Balance Sheets. Refer to Note 6 - Fair Value of Financial Instruments for the Company’s related valuation disclosures. Maximum exposure to losses related to the VIEs is limited to their carrying value and the Company does not have any future funding commitments to any VIE.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.