Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)
QUANTERIX CORPORATION
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except per share data)
March 31, 2024
December 31, 2023
ASSETS
Current assets:
Cash and cash equivalents
$
45,281
$
174,422
Marketable securities
256,640
146,902
Accounts receivable, net of allowance for expected credit losses
29,276
25,414
Inventory
26,015
22,365
Prepaid expenses and other current assets
9,551
9,291
Total current assets
366,763
378,394
Restricted cash
2,605
2,604
Property and equipment, net
17,492
17,926
Intangible assets, net
5,339
6,034
Operating lease right-of-use assets
17,748
18,251
Other non-current assets
1,802
1,802
Total assets
$
411,749
$
425,011
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$
3,914
$
5,048
Accrued compensation and benefits
6,706
13,659
Accrued expenses and other current liabilities
7,021
6,041
Deferred revenue
10,234
9,468
Operating lease liabilities
4,366
4,241
Total current liabilities
32,241
38,457
Deferred revenue, net of current portion
933
1,227
Operating lease liabilities, net of current portion
36,084
37,223
Other non-current liabilities
1,053
1,177
Total liabilities
70,311
78,084
Commitments and contingencies (Note 12)
Stockholders’ equity:
Common stock, $ 0.001 par value per share:
Authorized: 120,000 shares; issued and outstanding: 38,353 and 38,014 shares at March 31, 2024 and December 31, 2023 , respectively
38
38
Additional paid-in capital
789,006
783,142
Accumulated other comprehensive loss
( 3,038 )
( 1,757 )
Accumulated deficit
( 444,568 )
( 434,496 )
Total stockholders’ equity
341,438
346,927
Total liabilities and stockholders’ equity
$
411,749
$
425,011
The accompanying notes are an integral part of these Consolidated Financial Statements.
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QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except per share data)
Three Months Ended March 31,
2024
2023
Revenues:
Product revenue
$
19,670
$
19,287
Service and other revenue
11,967
8,579
Collaboration and license revenue
155
368
Grant revenue
274
222
Total revenues
32,066
28,456
Costs of goods sold and services:
Cost of product revenue
7,145
7,033
Cost of service and other revenue
5,295
4,497
Total costs of goods sold and services
12,440
11,530
Gross profit
19,626
16,926
Operating expenses:
Research and development
6,675
4,720
Selling, general and administrative
25,993
20,850
Other lease costs
924
776
Total operating expenses
33,592
26,346
Loss from operations
( 13,966 )
( 9,420 )
Interest income
3,948
3,449
Other income, net
206
8
Loss before income taxes
( 9,812 )
( 5,963 )
Income tax expense
( 260 )
( 140 )
Net loss
$
( 10,072 )
$
( 6,103 )
Net loss per common share, basic and diluted
$
( 0.26 )
$
( 0.16 )
Weighted-average common shares outstanding, basic and diluted
38,126
37,327
The accompanying notes are an integral part of these Consolidated Financial Statements.
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Q UANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(amounts in thousands)
Three Months Ended March 31,
2024
2023
Net loss
$
( 10,072 )
$
( 6,103 )
Other comprehensive loss, net of tax:
Unrealized losses on marketable securities
( 607 )
—
Foreign currency translation
( 674 )
42
Total other comprehensive income (loss)
( 1,281 )
42
Comprehensive loss
$
( 11,353 )
$
( 6,061 )
The accompanying notes are an integral part of these Consolidated Financial Statements.
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QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(amounts in thousands)
Three Months Ended March 31, 2024
Common Stock
Shares
Amount
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders' equity
Balance at December 31, 2023
38,014
$
38
$
783,142
$
( 1,757 )
$
( 434,496 )
$
346,927
Issuance of common stock under stock plans, including tax effects
274
—
599
—
—
599
Stock-based compensation expense
—
—
5,265
—
—
5,265
Unrealized loss on marketable securities, net of tax
—
—
—
( 607 )
—
( 607 )
Foreign currency translation
—
—
—
( 674 )
—
( 674 )
Net loss
—
—
—
—
( 10,072 )
( 10,072 )
Balance at March 31, 2024
38,288
$
38
$
789,006
$
( 3,038 )
$
( 444,568 )
$
341,438
Three Months Ended March 31, 2023
Common Stock
Shares
Amount
Additional paid-in capital
Accumulated other comprehensive income (loss)
Accumulated deficit
Total stockholders' equity
Balance at December 31, 2022
37,280
$
37
$
763,688
$
( 2,623 )
$
( 402,162 )
$
358,940
Issuance of common stock under stock plans, including tax effects
144
—
551
—
—
551
Stock-based compensation expense
—
—
3,902
—
—
3,902
Foreign currency translation
—
—
—
42
—
42
Net loss
—
—
—
—
( 6,103 )
( 6,103 )
Balance at March 31, 2023
37,424
$
37
$
768,141
$
( 2,581 )
$
( 408,265 )
$
357,332
The accompanying notes are an integral part of these Consolidated Financial Statements.
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QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
Three Months Ended March 31,
2024
2023
Cash flows from operating activities:
Net loss
$
( 10,072 )
$
( 6,103 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
1,523
1,439
Credit losses on accounts receivable
176
178
Accretion of marketable securities
( 1,657 )
—
Operating lease right-of-use asset amortization
478
334
Stock-based compensation expense
5,265
3,902
Other operating activity
55
270
Changes in assets and liabilities:
Accounts receivable
( 4,233 )
( 3,741 )
Inventory
( 3,670 )
( 89 )
Prepaid expenses and other current assets
( 254 )
( 422 )
Other non-current assets
( 21 )
( 33 )
Accounts payable
( 1,122 )
( 1,271 )
Accrued compensation and benefits, accrued expenses, and other current liabilities
( 6,126 )
( 5,983 )
Deferred revenue
472
2,041
Operating lease liabilities
( 988 )
179
Other non-current liabilities
10
( 203 )
Net cash used in operating activities
( 20,164 )
( 9,502 )
Cash flows from investing activities:
Purchases of marketable securities
( 137,889 )
—
Proceeds from maturities of marketable securities
29,200
—
Purchases of property and equipment
( 506 )
( 136 )
Net cash used in investing activities
( 109,195 )
( 136 )
Cash flows from financing activities:
Proceeds from common stock issued under stock plans
2,037
564
Payments for employee taxes withheld on stock-based compensation awards
( 1,438 )
( 13 )
Net cash provided by financing activities
599
551
Net decrease in cash, cash equivalents, and restricted cash
( 128,760 )
( 9,087 )
Effect of exchange rate changes on cash, cash equivalents, and restricted cash
( 380 )
24
Cash, cash equivalents, and restricted cash at beginning of period
177,026
341,337
Cash, cash equivalents, and restricted cash at end of period
$
47,886
$
332,274
Supplemental disclosure of cash flow information:
Cash paid for taxes
$
175
$
246
Purchases of property and equipment in accounts payable and accrued expenses
$
222
$
147
The accompanying notes are an integral part of these Consolidated Financial Statements.
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QUANTERIX CORPORATION
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 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. To date, the Company has completed over 2,300 projects for more than 480 customers from all over the world using its Simoa platforms.
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 months ended March 31, 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 twelve-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
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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, net on the Consolidated Statements of Operations and were not material for the three months ended March 31, 2024 and 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 March 31,
2024
2023
Cash and cash equivalents
$
45,281
$
329,354
Restricted cash
2,605
2,920
Cash, cash equivalents, and restricted cash
$
47,886
$
332,274
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.
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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, infectious disease, and other protein biomarkers associated with diseases. The Company’s customer base includes pharmaceutical, biotechnology, contract research organizations, academic, and government institutions.
Disaggregated Revenue
When disaggregating revenue, the Company considers all of the economic factors that may affect its revenues. 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 March 31, 2024
Three Months Ended March 31, 2023
North America
EMEA
Asia Pacific
Total
North America
EMEA
Asia Pacific
Total
Product revenue:
Instruments
$
408
$
1,269
$
869
$
2,546
$
2,144
$
1,981
$
1,135
$
5,260
Consumable and other products
10,242
4,041
2,841
17,124
7,457
4,940
1,630
14,027
Total
$
10,650
$
5,310
$
3,710
$
19,670
$
9,601
$
6,921
$
2,765
$
19,287
Service revenue:
Service-type warranties
$
1,637
$
852
$
194
$
2,683
$
1,557
$
706
$
135
$
2,398
Research services
5,762
2,802
127
8,691
5,190
234
115
5,539
Other services
318
248
27
593
381
257
4
642
Total
$
7,717
$
3,902
$
348
$
11,967
$
7,128
$
1,197
$
254
$
8,579
Collaboration and license revenue:
Total
$
67
$
88
$
—
$
155
$
368
$
—
$
—
$
368
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For the three months ended March 31, 2024, no customer accounted for more than 10 % of the Company’s total revenues and for the three months ended March 31, 2023, one customer accounted for more than 10 % of the Company’s total revenues. At March 31, 2024 and December 31, 2023, one customer accounted for more than 10 % of the Company’s gross accounts receivable.
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 a statement of work under the Lilly Collaboration Agreement to perform assay research and development services within the field of Alzheimer’s disease. Under the statement of work, the Company receives $ 1.5 million per calendar quarter, which began in the first quarter of 2022. The statement of work automatically renews on a quarterly basis until Lilly provides a termination notice in accordance with the terms of the Lilly Collaboration Agreement. As of March 31, 2024, the Lilly Collaboration Agreement and the statement of work were still in effect.
Concurrent with the execution of the Lilly Collaboration Agreement, the Company entered into a Technology License Agreement (the “Lilly License”) under which Lilly granted the Company a non-exclusive license to Lilly’s proprietary p-Tau 217 antibody technology for use in research use only products and 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 $ 1.5 million of revenue from the Lilly Collaboration Agreement during the three months ended March 31, 2024 and 2023.
Contract Assets
There were no contract assets as of March 31, 2024 or December 31, 2023.
Deferred Revenue
During the three months ended March 31, 2024 and 2023, the Company recognized $ 2.7 million and $ 2.4 million of revenue, respectively, related to its deferred revenue balance at January 1 of each such period.
Remaining Performance Obligations
As of March 31, 2024, the aggregate amount of transaction prices allocated to performance obligations that were not yet satisfied, or were partially satisfied, was $ 11.2 million. Of this amount, $ 10.2 million is expected to be recognized as revenue in the next 12 months , with the remainder expected to be recognized thereafter. The $ 11.2 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
$
288
$
377
Capitalization of costs to obtain a contract
97
197
Recognition of costs to obtain a contract
( 95 )
( 191 )
Balance at March 31
$
290
$
383
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The Company evaluates potential impairment of these amounts at each balance sheet date, and no related impairments were recorded during the three months ended March 31, 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 March 31, 2024, the Company had received $ 0.8 million of the total award value.
During the three months ended March 31, 2024 and 2023, grant revenue recognized and research and development expenses incurred were not 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 Alzheimer's disease. 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 June 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 months ended March 31, 2024 and 2023 grant revenue recognized and research and development expenses incurred were not material. As of March 31, 2024, the Company had $ 1.0 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
176
178
Write-offs and recoveries collected
( 103 )
( 74 )
Balance at March 31
$
527
$
222
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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 March 31, 2024
Amortized Cost
Unrealized Gains
Unrealized Losses
Fair Value
Commercial paper
$
42,947
$
—
$
( 40 )
$
42,907
U.S. Treasuries
73,033
—
( 23 )
73,010
U.S. Government agency bonds
78,389
10
( 149 )
78,250
Corporate bonds
79,012
55
( 136 )
78,931
Total marketable securities
$
273,381
$
65
$
( 348 )
$
273,098
Marketable securities are recorded in the following Consolidated Balance Sheets captions:
Cash and cash equivalents
$
16,458
Marketable securities
256,640
Total marketable securities
$
273,098
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 March 31, 2024
Fair Value
Unrealized Losses
Commercial paper
$
38,497
$
( 40 )
U.S. Treasuries
73,010
( 23 )
U.S. Government agency bonds
69,825
( 149 )
Corporate bonds
48,629
( 136 )
Total
$
229,961
$
( 348 )
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 March 31, 2024. For marketable securities in an unrealized loss position, the Company does not intend to sell them before recovery of their amortized cost bases, 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.
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The Company did not sell any marketable securities or record any realized gains or losses for the three months ended March 31, 2024. At March 31, 2024 and December 31, 2023, the Company had $ 1.2 million and $ 1.0 million, respectively, of accrued interest receivable on its marketable securities, which was recorded in prepaid expenses and other current assets on the Consolidated Balance Sheets.
The following table summarizes the contractual maturities of the Company’s marketable securities (in thousands):
As of March 31, 2024
As of December 31, 2023
Amortized Cost
Fair Value
Amortized Cost
Fair Value
Due within one year
$
209,554
$
209,378
$
95,188
$
95,232
Due in one to two years
63,827
63,720
58,282
58,563
Total
$
273,381
$
273,098
$
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 March 31, 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
$
19,792
$
19,792
$
—
$
—
U.S. Treasuries
16,458
—
16,458
—
Total cash equivalents
36,250
19,792
16,458
—
Marketable securities:
Commercial paper
42,907
—
42,907
—
U.S. Treasuries
56,552
—
56,552
—
U.S. Government agency bonds
78,250
—
78,250
—
Corporate bonds
78,931
—
78,931
—
Total marketable securities
256,640
—
256,640
—
Total financial assets
$
292,890
$
19,792
$
273,098
$
—
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.
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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
The Company has a non-marketable equity investment in an entity that is evaluated under the VIE guidance (refer to Note 14 - Variable Interest Entities for further discussion). Pursuant to ASC 321 – Investments – Equity Securities , the Company uses the measurement alternative for equity investments without readily determinable fair values and recognizes its non-marketable equity investment at cost, less any impairment, and adjusted for any observable price changes in orderly transactions. The Company’s investment is classified as a Level 3 financial asset. Changes in the inputs and assumptions used to determine the fair value would result in a higher or lower fair value measurement.
The Company’s non-marketable equity investment 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 months ended March 31, 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 March 31, 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.
Other Fair Value Disclosures
During the three months ended March 31, 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):
March 31, 2024
December 31, 2023
Raw materials
$
6,369
$
5,114
Work in process
7,371
4,466
Finished goods
12,275
12,785
Total inventory
$
26,015
$
22,365
Note 8. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
March 31, 2024
December 31, 2023
Accrued professional services
$
1,947
$
1,596
Accrued royalties
1,631
1,689
Accrued tax liabilities
1,485
808
Other accrued expenses
1,958
1,948
Total accrued expenses and other current liabilities
$
7,021
$
6,041
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Note 9. Stock-Based Compensation
Stock Options
Stock option activity for the three months ended March 31, 2024 is presented below (in thousands, except per share and contractual life amounts):
Weighted-average
Weighted-average
remaining contractual
Aggregate
Number of options
exercise price per share
life (in years)
intrinsic value
Outstanding at December 31, 2023
2,774
$
19.62
7.9
$
26,941
Granted
1,179
22.74
Exercised
( 104 )
12.34
Forfeited/expired
( 181 )
20.24
Outstanding at March 31, 2024
3,668
$
20.80
8.3
$
17,741
Exercisable at March 31, 2024
1,297
$
22.24
6.6
$
7,615
Vested and expected to vest at March 31, 2024
3,668
$
20.80
8.3
$
17,741
Restricted Stock Units
Restricted stock unit (“RSU”) activity for the three months ended March 31, 2024 is presented below (in thousands, except per share amounts):
Weighted-average
grant date fair
Number of shares
value per share
Unvested at December 31, 2023
1,328
$
17.87
Granted
446
24.40
Vested
( 197 )
17.57
Forfeited
( 96 )
20.52
Unvested at March 31, 2024
1,481
$
19.71
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 three months ended March 31, 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 March 31,
2024
2023
Cost of product revenue
$
281
$
187
Cost of service and other revenue
308
350
Research and development
543
370
Selling, general and administrative
4,133
2,995
Total stock-based compensation expense
$
5,265
$
3,902
As of March 31, 2024, there was $ 56.0 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 3.1 years.
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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 March 31,
2024
2023
Numerator:
Net loss
$
( 10,072 )
$
( 6,103 )
Denominator:
Weighted average common shares outstanding, basic and diluted
38,126
37,327
Net loss per share, basic and diluted
$
( 0.26 )
$
( 0.16 )
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):
Three Months Ended March 31,
2024
2023
Stock options
3,520
2,720
Common stock and RSUs
1,497
1,489
Estimated ESPP purchases
19
26
Total dilutive shares
5,036
4,235
Note 11. Income Taxes
The Company’s effective tax rates were ( 2.6 )% and ( 2.4 )% for the three months ended March 31, 2024 and 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 $ 2.1 million has been paid, and $ 1.6 million is due within one year from March 31, 2024.
During the three months ended March 31, 2024 and 2023, STRATEC shipped 35 thousand and 75 thousand discs, respectively, to the Company. The Company recorded cost of product revenue related to these shipments of $ 0.3 million and $ 0.5 million for the three months ended March 31, 2024 and 2023, respectively. During 2024, STRATEC is
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required to ship 222 thousand discs to the Company. During the three months ended March 31, 2024, 35 thousand discs were shipped.
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 March 31, 2024, the Company’s total purchase commitments under these agreements were $ 3.8 million, most of which the Company expects to incur in the year ending December 31, 2024.
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 this license, 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 incurred no royalty expense under the Harvard License Agreement for the three months ended March 31, 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 $ 0.5 million and $ 0.4 million during the three months ended March 31, 2024 and 2023, respectively, which was 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. The Company records contingent liabilities when losses are probable and estimable. If an estimate of a probable loss is a range and no amount within the range is more likely than any other amount in the range, the Company records the minimum amount of the range.
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Leases
The undiscounted future lease payments for non-cancelable operating leases were as follows (in thousands):
Maturity of lease liabilities
As of March 31, 2024
2024 (remainder)
$
5,340
2025
7,254
2026
7,408
2027
7,641
2028
7,880
2029
8,126
Thereafter
7,612
Total lease payments
51,261
Less: imputed interest
10,811
Total operating lease liabilities
$
40,450
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 March 31, 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. A member of the Company’s Board of Directors is also affiliated with Harvard and Mass General Brigham. Revenue recorded from sales of products and services to Harvard and its affiliates and to Mass General Brigham and its affiliates was $ 0.3 million for both the three months ended March 31, 2024 and 2023. Cost of product revenue and operating expenses with Harvard and Mass General Brigham were not material for the three months ended March 31, 2024 and 2023. At March 31, 2024 and December 31, 2023, open payables to and receivable balances from Harvard and Mass General Brigham were not material.
In May 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 IVD market. 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 was no longer a member of the Company’s Board of Directors. Revenue recorded from sales of products and services to UltraDx totaled $1.1 million for the three months ended March 31, 2024. Cost of product revenue and services was not material for the three months ended March 31, 2024. At March 31, 2024 there was $1.2 million in open receivable balances and no open payable balances to UltraDx.
Revenue and cost of product revenue and services for three months ended March 31, 2023 were not material. At December 31, 2023, there were no open payable balances to UltraDx and open receivable balances from UltraDx were not material.
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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 of these entities meet the definition of a VIE and require consolidation into its financial statements. The Company’s analysis determines whether it has a controlling financial interest and also identifies the primary beneficiary of a VIE as the enterprise that has both (1) the power to direct activities of a VIE that most significantly impact the entity’s economic performance and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity.
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 months ended March 31, 2024 and 2023.
As of March 31, 2024 and December 31, 2023, the carrying value of the Company’s investment 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 VIE is limited to its carrying value and the Company does not have any future funding commitments to any VIE.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.