Item 1. Financial Statements
Item 1. Financial Statements (Unaudited)
QUANTERIX CORPORATION
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except per share data)
September 30, 2023
December 31, 2022
ASSETS
Current assets:
Cash and cash equivalents
$
201,261
$
338,740
Marketable securities
126,449
—
Accounts receivable (net of allowance for expected credit losses of $ 429 and $ 118 as of September 30, 2023 and December 31, 2022, respectively)
24,083
19,017
Inventory
19,945
16,786
Prepaid expenses and other current assets
9,273
6,860
Total current assets
381,011
381,403
Restricted cash
2,647
2,597
Property and equipment, net
17,517
20,162
Intangible assets, net
6,003
7,516
Operating lease right-of-use assets
19,860
21,223
Other non-current assets
2,004
1,298
Total assets
$
429,042
$
434,199
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$
4,786
$
3,836
Accrued compensation and benefits
9,775
10,658
Accrued expenses and other current liabilities
6,672
5,133
Deferred revenue
9,827
8,644
Operating lease liabilities
4,093
2,687
Total current liabilities
35,153
30,958
Deferred revenue, net of current portion
1,126
1,415
Operating lease liabilities, net of current portion
38,306
41,417
Other non-current liabilities
1,105
1,469
Total liabilities
75,690
75,259
Commitments and contingencies (Note 13)
Stockholders’ equity:
Common stock, $ 0.001 par value, per share:
Authorized shares: 120,000 ; Issued and outstanding: 37,839 and 37,280 shares at September 30, 2023 and December 31, 2022 , respectively
38
37
Additional paid-in capital
778,615
763,688
Accumulated other comprehensive loss
( 3,214 )
( 2,623 )
Accumulated deficit
( 422,087 )
( 402,162 )
Total stockholders’ equity
353,352
358,940
Total liabilities and stockholders’ equity
$
429,042
$
434,199
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 September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Revenues:
Product revenue
$
19,660
$
17,693
$
58,639
$
53,134
Service revenue
10,938
8,370
30,069
25,728
Collaboration and license revenue
237
301
1,234
479
Grant revenue
499
282
877
357
Total revenues
31,334
26,646
90,819
79,698
Costs of goods sold and services:
Cost of product revenue
8,342
10,511
22,611
31,178
Cost of service and other revenue
5,209
5,191
14,361
14,306
Total costs of goods sold and services
13,551
15,702
36,972
45,484
Gross profit
17,783
10,944
53,847
34,214
Operating expenses:
Research and development
7,200
6,631
17,866
20,290
Selling, general, and administrative
23,595
19,966
66,069
72,723
Other lease costs
758
609
2,696
609
Impairment and restructuring
—
20,341
( 33 )
20,341
Total operating expenses
31,553
47,547
86,598
113,963
Loss from operations
( 13,770 )
( 36,603 )
( 32,751 )
( 79,749 )
Interest income, net
4,185
1,712
11,520
2,316
Other income (expense), net
2,030
( 101 )
1,884
( 676 )
Loss before income taxes
( 7,555 )
( 34,992 )
( 19,347 )
( 78,109 )
Income tax expense
( 203 )
( 72 )
( 578 )
( 10 )
Net loss
$
( 7,758 )
$
( 35,064 )
$
( 19,925 )
$
( 78,119 )
Net loss per common share, basic and diluted
$
( 0.21 )
$
( 0.95 )
$
( 0.53 )
$
( 2.12 )
Weighted-average common shares outstanding, basic and diluted
37,657
37,005
37,494
36,927
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 September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Net loss
$
( 7,758 )
$
( 35,064 )
$
( 19,925 )
$
( 78,119 )
Other comprehensive loss, net of tax:
Unrealized losses on marketable securities
( 241 )
—
( 241 )
—
Foreign currency translation
( 148 )
( 796 )
( 350 )
( 3,440 )
Total other comprehensive loss
( 389 )
( 796 )
( 591 )
( 3,440 )
Comprehensive loss
$
( 8,147 )
$
( 35,860 )
$
( 20,516 )
$
( 81,559 )
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 September 30, 2023
Common stock
Shares
Value
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders' equity
Balance at June 30, 2023
37,566
$
37
$
772,473
$
( 2,825 )
$
( 414,329 )
$
355,356
Issuance of common stock under stock plans, including tax effects
273
1
1,799
—
—
1,800
Stock-based compensation expense
—
—
4,343
—
—
4,343
Unrealized loss on marketable securities, net of tax
( 241 )
( 241 )
Foreign currency translation
—
—
—
( 148 )
—
( 148 )
Net loss
—
—
—
—
( 7,758 )
( 7,758 )
Balance at September 30, 2023
37,839
$
38
$
778,615
$
( 3,214 )
$
( 422,087 )
$
353,352
Three Months Ended September 30, 2022
Common stock
Shares
Value
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders' equity
Balance at June 30, 2022
36,975
$
37
$
756,139
$
( 2,203 )
$
( 348,517 )
$
405,456
Issuance of common stock under stock plans, including tax effects
119
—
407
—
—
407
Stock-based compensation expense
—
—
2,766
—
—
2,766
Foreign currency translation
—
—
—
( 796 )
—
( 796 )
Net loss
—
—
—
—
( 35,064 )
( 35,064 )
Balance at September 30, 2022
37,094
$
37
$
759,312
$
( 2,999 )
$
( 383,581 )
$
372,769
Nine Months Ended September 30, 2023
Common stock
Shares
Value
Additional paid-in capital
Accumulated other comprehensive 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
559
1
2,489
—
—
2,490
Stock-based compensation expense
—
—
12,438
—
—
12,438
Unrealized loss on marketable securities, net of tax
—
—
—
( 241 )
—
( 241 )
Foreign currency translation
—
—
—
( 350 )
—
( 350 )
Net loss
—
—
—
—
( 19,925 )
( 19,925 )
Balance at September 30, 2023
37,839
$
38
$
778,615
$
( 3,214 )
$
( 422,087 )
$
353,352
Nine Months Ended September 30, 2022
Common stock
Shares
Value
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders' equity
Balance at December 31, 2021
36,768
$
37
$
745,936
$
441
$
( 305,462 )
$
440,952
Issuance of common stock under stock plans, including tax effects
326
—
1,597
—
—
1,597
Stock-based compensation expense
—
—
11,779
—
—
11,779
Foreign currency translation
—
—
—
( 3,440 )
—
( 3,440 )
Net loss
—
—
—
—
( 78,119 )
( 78,119 )
Balance at September 30, 2022
37,094
$
37
$
759,312
$
( 2,999 )
$
( 383,581 )
$
372,769
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)
Nine Months Ended September 30,
2023
2022
Cash flows from operating activities:
Net loss
$
( 19,925 )
$
( 78,119 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
4,788
4,186
Credit losses on accounts receivable
311
102
Foreign currency losses
359
167
Unrealized losses on marketable securities
( 241 )
—
Amortization of (discount) premium on marketable securities
( 1,249 )
—
Operating lease right-of-use asset amortization
1,518
1,099
Stock-based compensation expense
12,438
11,779
Impairment
—
16,915
Deferred income taxes
242
( 134 )
Loss on disposal of fixed assets
46
6
Changes in assets and liabilities:
Accounts receivable
( 5,615 )
5,045
Inventory
( 2,966 )
3,919
Prepaid expenses and other current assets
( 2,829 )
( 262 )
Other non-current assets
( 716 )
( 859 )
Accounts payable
948
( 7,085 )
Accrued compensation and benefits, accrued expenses, and other current liabilities
876
( 3,021 )
Deferred revenue
894
3,108
Operating lease liabilities
( 1,690 )
( 1,156 )
Other non-current liabilities
( 107 )
128
Net cash used in operating activities
( 12,918 )
( 44,182 )
Cash flows from investing activities:
Purchases of marketable securities
( 125,200 )
—
Purchases of property and equipment
( 1,572 )
( 10,131 )
Proceeds from RADx grant on assets purchased
—
520
Net cash used in investing activities
( 126,772 )
( 9,611 )
Cash flows from financing activities:
Proceeds from common stock issued under stock plans
2,632
1,597
Payments for employee taxes withheld on stock-based compensation awards
( 142 )
—
Net cash provided by financing activities
2,490
1,597
Net decrease in cash, cash equivalents, and restricted cash
( 137,200 )
( 52,196 )
Effect of exchange rate changes on cash, cash equivalents, and restricted cash
( 229 )
( 507 )
Cash, cash equivalents, and restricted cash at beginning of period
341,337
399,042
Cash, cash equivalents, and restricted cash at end of period
$
203,908
$
346,339
Supplemental disclosure of cash flow information:
Cash paid for taxes
$
719
$
263
Operating lease right-of-use assets obtained in exchange for lease liabilities
$
—
$
22,239
Shares received as consideration under product sales agreement (Note 3, 6)
$
775
$
—
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 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. The Company is currently focusing on protein detection, but its Simoa platforms have also demonstrated applicability across other testing applications, including detection of nucleic acids and small molecules.
The Company also provides contract research services for customers and Laboratory Developed Test (“LDT”) services through its CLIA-certified Accelerator Laboratory (the “Accleerator Laboratory”). The Accelerator Laboratory provides customers with access to Simoa technology 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 2,200 projects for more than 470 customers from all over the world using its Simoa platforms.
Note 2. Significant Accounting Policies
Basis of Presentation
The Consolidated Financial Statements have been prepared in accordance with the 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, 2022 included herein was derived from the audited Consolidated Financial Statements as of December 31, 2022, but does not include all disclosures required by U.S. GAAP on an annual reporting basis. Certain prior period amounts have been reclassified to conform to the current period 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, 2022, as filed with the SEC on March 6, 2023. 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 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 nine months ended September 30, 2023 may not be indicative of the results for the full year ended December 31, 2023 or any other period.
The Company’s fiscal year is the twelve-month period from January 1 through December 31.
Use of Estimates
The preparation of the Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts of assets, liabilities, revenues, and expenses reported and disclosures in the financial statements and accompanying notes. Such estimates include, but are not limited to, revenue recognition, valuation of inventory, leases, valuation of intangible and other long-lived assets, recoverability of deferred
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tax assets, ongoing impairment reviews, and stock-based compensation expense. The Company bases its estimates on historical experience, known trends, market specific information, or other relevant factors it believes to be reasonable. On an ongoing basis, management evaluates its estimates and changes in estimates are recorded in the period in which they become known. Actual results may differ from these estimates.
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. Foreign exchange losses were not material during the nine months ended September 30, 2023, and were $ 0.8 million during the nine months ended September 30, 2022.
Principles of Consolidation
The 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 its investment interests 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 16 − Variable Interest Entities for further discussion.
Presentation of 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 September 30,
2023
2022
Cash and cash equivalents
$
201,261
$
343,743
Restricted cash (1)
2,647
2,596
Cash, cash equivalents, and restricted cash
$
203,908
$
346,339
(1) Restricted cash consists of collateral for a letter of credit issued as security for several 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.
Marketable Securities
The Company’s current portfolio of marketable securities is entirely debt securities and may at any time include commercial paper, U.S. Treasuries, corporate notes and bonds, U.S. Government agency bonds, certificates of deposit, and similar types of debt securities. Marketable debt securities with original maturities of three months or less at the time of purchase are recorded in cash equivalents on the Consolidated Balance Sheets as they are considered highly liquid and readily convertible into cash. All other marketable securities, including those with maturities beyond one year, are recorded as current assets on the Consolidated Balance Sheets based on their highly liquid nature and because such securities are available for use in current operations.
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The Company classifies its marketable securities as either held to maturity, available-for-sale, or trading at the time of purchase and re-evaluates such classification at each balance sheet date. All of the Company’s marketable securities are currently classified as available-for-sale as it may use them in current operations. Available-for-sale securities are recorded at fair value (refer to Note 6 − Fair Value of Financial Instruments ).
Unrealized gains and losses (other than impairment or credit related losses) are recorded in accumulated other comprehensive income (loss), net of tax, a component of stockholders’ equity on the Consolidated Balance Sheets. Realized gains and losses are determined using the specific identification method and are recorded in other income (expense), net on the Consolidated Statements of Operations.
Quarterly, or more frequently if circumstances warrant, the Company monitors its marketable securities for impairment. In the event a security’s fair value is less than its amortized cost basis, the Company evaluates whether an impairment exists and if the impairment is a result of credit loss or other factors. For a security in an unrealized loss position, if the Company intends to sell the security in an unrealized loss position, or it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis, an impairment loss equal to the difference between the security’s fair value and amortized cost basis is recorded in other income (expense), net. Additionally, the Company determines if a credit loss exists by considering information about the collectability of the security, current market conditions, and the issuer’s financial condition. If a decline in fair value is a result of a credit loss, an allowance for credit losses is recorded in other income (expense), net, limited to the portion attributed to the credit loss.
Recent Accounting Pronouncements
There are no new accounting pronouncements issued or effective in the current or future periods that are expected to have a material impact on the Company’s Consolidated Financial Statements or accompanying notes.
Note 3. Revenue and Related Matters
Disaggregated Revenue
The following tables disaggregate 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 September 30, 2023
Three Months Ended September 30, 2022
North America
EMEA
Asia Pacific
Total
North America
EMEA
Asia Pacific
Total
Product revenue
Instruments
$
1,693
$
707
$
1,257
$
3,657
$
2,964
$
3,115
$
1,684
$
7,763
Consumable and other products
8,710
5,205
2,088
16,003
6,262
2,840
828
9,930
Total
$
10,403
$
5,912
$
3,345
$
19,660
$
9,226
$
5,955
$
2,512
$
17,693
Service revenue
Service-type warranties
$
1,595
$
810
$
161
$
2,566
$
1,454
$
703
$
125
$
2,282
Research services
6,690
617
433
7,740
5,246
305
44
5,595
Other services
388
243
1
632
315
142
36
493
Total
$
8,673
$
1,670
$
595
$
10,938
$
7,015
$
1,150
$
205
$
8,370
Collaboration and license revenue
$
237
$
—
$
—
$
237
$
136
$
165
$
—
$
301
Grant revenue
$
499
$
—
$
—
$
499
$
282
$
—
$
—
$
282
Total revenues
$
19,812
$
7,582
$
3,940
$
31,334
$
16,659
$
7,270
$
2,717
$
26,646
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Nine Months Ended September 30, 2023
Nine Months Ended September 30, 2022
North America
EMEA
Asia Pacific
Total
North America
EMEA
Asia Pacific
Total
Product revenue
Instruments
$
4,879
$
3,659
$
3,864
$
12,402
$
7,602
$
7,288
$
4,699
$
19,589
Consumable and other products
25,978
14,692
5,567
46,237
19,814
10,854
2,877
33,545
Total
$
30,857
$
18,351
$
9,431
$
58,639
$
27,416
$
18,142
$
7,576
$
53,134
Service revenue
Service-type warranties
$
4,711
$
2,269
$
449
$
7,429
$
4,057
$
2,050
$
341
$
6,448
Research services
18,200
1,562
1,001
20,763
16,853
752
65
17,670
Other services
1,142
719
16
1,877
916
590
104
1,610
Total
$
24,053
$
4,550
$
1,466
$
30,069
$
21,826
$
3,392
$
510
$
25,728
Collaboration and license revenue
$
1,234
$
—
$
—
$
1,234
$
179
$
248
$
52
$
479
Grant revenue
$
877
$
—
$
—
$
877
$
357
$
—
$
—
$
357
Total revenues
$
57,021
$
22,901
$
10,897
$
90,819
$
49,778
$
21,782
$
8,138
$
79,698
For each of the three and nine months ended September 30, 2023, one customer accounted for more than 10 % of the Company’s total revenues. At September 30, 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 14 − Related Party Transactions for a discussion of the related party relationships between Quanterix and these entities.
The Company determined that the instruments, components, and licenses formed a single, combined performance obligation. The consideration due to the Company included (1) cash proceeds of $ 1.9 million, which was received and recognized as revenue in the third quarter of 2022 when the instruments, components, and licenses were delivered to and paid by UltraDx, and (2) 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 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 the 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 the qualified preferred share financing and issued to the Company one million ordinary shares. Refer to Note 6 − Fair Value of Financial Instruments for the Company’s disclosures related to determining the fair value of the shares received. Also refer to Note 16 − Variable Interest Entities for additional information on the Company’s investment interests in UltraDx as a result of the share issuance.
During the three months ended September 30, 2023, revenue recognized was not material. During the nine months ended September 30, 2023, the Company recognized $ 1.6 million of revenue, which includes the one-time revenue from the receipt of the UltraDx shares in the second quarter of 2023. During the three and nine months ended September 30, 2022, the Company recognized $ 1.9 million of revenue.
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Service Revenue
Eli Lilly and Company
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. In connection with the Lilly Collaboration Agreement, the Company received a non-refundable up-front payment of $ 5.0 million during the first quarter of 2022, which was recognized over a one-year period. In addition, 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 September 30, 2023, 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 pTau217 antibody technology for 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 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 $ 4.5 million during the three and nine months ended September 30, 2023, respectively, and $ 2.7 million and $ 8.1 million during the three and nine months ended September 30, 2022, respectively.
Collaboration and License Revenue
Abbott Laboratories
On September 29, 2020, the Company and Abbott Laboratories (“Abbott”) entered into a Non-Exclusive License Agreement (the “Abbott License Agreement”) under which the Company granted Abbott a non-exclusive, worldwide, royalty-bearing license, without the right to sublicense, to the Company’s bead-based single molecule detection patent (the “Licensed Patents”) in the field of in vitro diagnostics. Abbott paid the Company an initial license fee of $ 10.0 million, which was recognized as license revenue during 2020. Abbott also agreed to pay the Company milestone fees, subject to the achievement by Abbott of certain development, regulatory, and commercialization milestones and low single-digit royalties on net sales of licensed products.
The Abbott License Agreement will continue until expiration of the last-to-expire licensed patent, or the agreement is earlier terminated. Under the terms of the Abbott License Agreement, the Company and Abbott each have the right to terminate the agreement for uncured material breach by, or insolvency of, the other party. Abbott may also terminate the Abbott License Agreement at any time, without cause, upon 60 days ’ notice.
During the three and nine months ended September 30, 2023, the Company recognized zero and $ 0.5 million of one-time revenue, respectively, related to the expiration of a previously paid for option to expand the scope of the Abbott License Agreement.
Grant Revenue
The Company recognizes grant revenue after funding is committed and as each grant’s related activities are performed. The timing of revenue recognition and receipt of funding varies by grant and can be independent from performance of the related activities, such as an upfront payment of the award value, or subsequent to the Company’s requests for reimbursement for already performed activities (subject to the approval of the granting organization), as further described below.
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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 September 30, 2023, the Company had received $ 0.5 million of the award value.
During the three months ended September 30, 2023, grant revenue recognized and research and development expenses incurred were not material. During the nine months ended September 30, 2023, grant revenue recognized and research and development expenses incurred were $ 0.5 million and $ 0.4 million, respectively. During the three and nine months ended September 30, 2022, 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 in vitro diagnostic 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 September 30, 2023, the Company had received the total funding value of $ 2.3 million.
During the three and nine months ended September 30, 2023, grant revenue recognized and research and development expenses incurred were $ 0.3 million and $ 0.4 million, respectively. During the three and nine months ended September 30, 2022, grant revenue recognized and research and development expenses incurred were $ 0.3 million and $ 0.4 million, respectively.
RADx Grant
On September 29, 2020, the Company entered into a contract with the NIH under its Rapid Acceleration of Diagnostics (“RADx”) program (the “RADx Grant”), with a total award value of $ 18.2 million. The RADx Grant was to accelerate the continued development, scale-up, and deployment of the novel SARS-CoV-2 antigen detection test using the Company’s Simoa technology. Grant funding was used to expand assay kit manufacturing capacity and commercial deployment readiness, and the contract ran through the final milestone on May 31, 2022. Receipt of the award value occurred throughout the term of the contract period and after the Company submitted for reimbursement of activities related to the grant. During the first half of 2022, the Company received $ 0.5 million which represented the final and total funding value of the $ 18.2 million award.
During the three and nine months ended September 30, 2023 and 2022, the Company recognized no grant revenue and incurred no research and development expenses. As of September 30, 2023, the Company had no future obligations under the RADx Grant.
Contract Assets
There were no contract assets of as September 30, 2023 or December 31, 2022.
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Deferred Revenue
The Company refers to contract liabilities as deferred revenue on the Consolidated Balance Sheets. During the nine months ended September 30, 2023 and 2022, the Company recognized $ 6.4 million and $ 4.7 million of revenue, respectively, related to its deferred revenue balance at January 1 of each such period.
Remaining Performance Obligations
As of September 30, 2023, the aggregate amount of transaction prices allocated to performance obligations that have not yet been satisfied, or are partially satisfied, was $ 11.0 million.
Of the performance obligations not yet satisfied or partially satisfied, $ 9.8 million is expected to be recognized as revenue in the next 12 months , with the remainder expected to be recognized thereafter. The $ 9.8 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
The Company capitalizes commissions paid to its sales representatives and related fringe benefits costs that are incremental to obtaining customer contracts. These costs are included in prepaid expenses and other current assets on the Consolidated Balance Sheets. Changes in costs to obtain a contract were as follows (in thousands):
2023
2022
Balance at December 31 of prior year
$
377
$
440
Deferral of costs to obtain a contract
414
1,182
Amortization of costs to obtain a contract
( 491 )
( 914 )
Balance at September 30
$
300
$
708
Costs to obtain a contract are amortized to earnings over the life of the contract and are recorded in cost of goods sold and selling, general, and administrative expense on the Consolidated Statements of Operations. The Company evaluates potential impairment of these amounts at each balance sheet date, and no related impairments were recorded during the nine months ended September 30, 2023 and 2022.
Note 4. Allowance for Credit Losses
The Company is exposed to credit losses primarily through accounts receivable from sales of its products and services. The Company’s expected credit loss allowance methodology is developed using historical collection experience, current and future economic and market conditions, and a review of the status of customers’ accounts receivable.
The change in the allowance for credit losses on accounts receivable is summarized as follows (in thousands):
2023
2022
Balance at December 31 of prior year
$
118
$
419
Provision for expected credit losses
605
102
Write-offs and recoveries collected
( 294 )
—
Balance at September 30
$
429
$
521
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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 September 30, 2023
Amortized cost
Unrealized Gains
Unrealized Losses
Fair Value
Commercial paper
$
75,934
$
—
$
( 55 )
$
75,879
U.S. Treasuries
16,195
1
( 1 )
16,195
U.S. Government agency bonds
24,109
6
( 50 )
24,065
Corporate bonds
35,729
—
( 142 )
35,587
Total marketable securities
$
151,967
$
7
$
( 248 )
$
151,726
Marketable securities are reported in the following Consolidated Balance Sheets captions:
Cash and cash equivalents
$
25,277
Marketable securities
126,449
Total marketable securities
$
151,726
The Company did no t have any marketable securities as of December 31, 2022.
The following table shows the gross unrealized losses and fair value 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 September 30, 2023
Fair Value
Unrealized Losses
Commercial paper
$
75,879
$
( 55 )
U.S. Treasuries
5,940
( 1 )
U.S. Government agency bonds
13,328
( 50 )
Corporate bonds
35,587
( 142 )
Total
$
130,734
$
( 248 )
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 September 30, 2023. 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.
The Company did not sell any marketable securities or record any realized gains or losses for the three and nine months ended September 30, 2023. At September 30, 2023, the Company had $ 0.4 million 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 September 30, 2023
Amortized cost
Fair Value
Due within one year
$
110,743
$
110,670
Due in one to two years
41,224
41,056
Total
$
151,967
$
151,726
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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 September 30, 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
$
153,306
$
153,306
$
—
$
—
Commercial paper
19,006
—
19,006
—
U.S. Treasuries
6,271
—
6,271
—
Total cash equivalents:
178,583
153,306
25,277
—
Marketable securities: (2)
Commercial paper
56,874
—
56,874
—
U.S. Treasuries
9,923
—
9,923
—
U.S. Government agency bonds
24,065
—
24,065
—
Corporate bonds
35,587
—
35,587
—
Total marketable securities
126,449
—
126,449
—
Total financial assets
$
305,032
$
153,306
$
151,726
$
—
As of December 31, 2022
Total
Quoted prices in active markets (Level 1)
Significant other observable inputs (Level 2)
Significant unobservable inputs (Level 3)
Financial assets:
Money market funds (1)
$
306,097
$
306,097
$
—
$
—
Total financial assets
$
306,097
$
306,097
$
—
$
—
(1) Included in cash and cash equivalents on the Consolidated Balance Sheets.
(2) Marketable securities are initially valued at their purchase price and subsequently fair 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
On June 26, 2023, the Company received ordinary shares in UltraDx (refer to Note 3 − Revenue and Related Matters ) which were valued at $ 1.0 million upon receipt, primarily using the third-party purchase price of similar interests issued during UltraDx’s financing event that closed in the second quarter of 2023. As UltraDx is a recently formed, privately held entity, there was 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. Changes in the inputs and assumptions used would have resulted in a higher or lower fair value measurement.
Pursuant to ASC 321 – Investments – Equity Securities , the Company has elected the measurement alternative for equity investments without readily determinable fair values and will continue to recognize the UltraDx shares at cost, less any impairment, and adjusted for any observable price changes in orderly transactions.
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During the third quarter of 2023, the Company recorded an immaterial adjustment to the fair value of the UltraDx shares. There were no other changes in the carrying value of these assets during the three and nine months ended September 30, 2023 and 2022. As of September 30, 2023 and December 31, 2022, the carrying value of the Company’s Level 3 financial assets was $ 1.1 million and $ 0.3 million, respectively, and are included in other non-current assets on the Consolidated Balance Sheets. Refer to Note 16 − Variable Interest Entities for further discussion.
Other Fair Value Disclosures
During the nine months ended September 30, 2023 and 2022, 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):
September 30, 2023
December 31, 2022
Raw materials
$
5,125
$
5,509
Work in process
4,907
3,362
Finished goods
9,913
7,915
Total inventory
$
19,945
$
16,786
Note 8. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
September 30, 2023
December 31, 2022
Accrued professional services
$
1,761
$
1,409
Accrued royalties
1,372
815
Accrued tax liabilities
1,716
172
Other accrued expenses
1,823
2,737
Total accrued expenses and other current liabilities
$
6,672
$
5,133
Note 9. Stock-Based Compensation
Stock Options
Stock option activity for the nine months ended September 30, 2023 is presented below (in thousands, except per share and contractual life amounts):
Weighted-average
Weighted-average
remaining contractual
Aggregate
Number of shares
exercise price per share
life (in years)
intrinsic value
Outstanding at December 31, 2022
2,188
$
20.69
8.1
$
4,273
Granted
1,102
15.74
Exercised
( 132 )
12.37
Cancelled
( 418 )
18.51
Outstanding at September 30, 2023
2,740
$
19.43
8.1
$
26,822
Exercisable at September 30, 2023
967
$
23.71
6.3
$
7,260
Vested and expected to vest at September 30, 2023
2,740
$
19.43
8.1
$
26,822
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Restricted Stock Units
Restricted stock unit (“RSU”) activity for the nine months ended September 30, 2023 is presented below (in thousands, except per share and contractual life amounts):
Weighted-average
Weighted-average
grant date fair
remaining contractual
Aggregate
Number of shares
value per share
life (in years)
intrinsic value
Unvested RSUs at December 31, 2022
1,188
$
21.18
9.6
$
16,455
Granted
812
15.49
Vested
(306)
24.52
Cancelled
(258)
17.59
Unvested RSUs at September 30, 2023
1,436
$
17.90
9.1
$
38,976
Expected to convert at September 30, 2023
1,436
$
17.90
9.1
$
38,976
Employee Stock Purchase Plan (“ESPP”)
In December 2017, the Company adopted the 2017 Employee Stock Purchase Plan (the “2017 ESPP”). The 2017 ESPP contains an “evergreen” provision, which allows for an increase in the number of shares under the plan on the first day of each fiscal year beginning with 2018. The increase is equal to the lower of: (i) 1 % of the number of shares of common stock outstanding on the last day of the immediately preceding fiscal year and (ii) an amount determined by the Company’s Board of Directors or Compensation Committee. On January 3, 2023, the number of shares of common stock available for issuance under the 2017 ESPP was increased by 372 thousand shares.
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 nine months ended September 30, 2023, employees purchased 121 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 September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Cost of product revenue
$
224
$
199
$
611
$
424
Cost of service and other revenue
259
159
867
530
Research and development
449
320
1,224
1,200
Selling, general, and administrative
3,411
2,088
9,736
9,625
Total stock-based compensation
$
4,343
$
2,766
$
12,438
$
11,779
As of September 30, 2023, there was $ 37.4 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.
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The fair value of the Company’s stock options granted and purchase rights to the ESPP were estimated using the Black-Scholes valuation model with the following assumptions:
Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Stock Options:
Risk-free interest rate
4.0 % − 4.4 %
2.7 % − 3.9 %
3.5 % − 4.4 %
1.4 % − 3.9 %
Expected dividend yield
None
None
None
None
Expected term (in years)
5.1
5.5 − 5.7
5.0 − 5.1
5.5 − 5.8
Expected volatility
82.6 % − 83.1 %
62.6 % − 69.8 %
71.1 % − 83.1 %
55.0 % − 69.8 %
Weighted-average grant date fair value
$
16.82
$
5.80
$
10.25
$
10.28
Employee Stock Purchase Plan:
Risk-free interest rate
5.5 %
3.3 % - 3.9 %
5.2 % - 5.5 %
0.7 % - 3.9 %
Expected dividend yield
None
None
None
None
Expected term (in years)
0.5
0.5
0.5
0.5
Expected volatility
74.7 % − 78.5 %
115.3 % − 117.3 %
72.8 % − 82.5 %
51.9 % − 117.3 %
Weighted-average grant date fair value
$
4.39
$
3.02
$
2.63
$
3.85
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 September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Numerator:
Net loss
$
( 7,758 )
$
( 35,064 )
$
( 19,925 )
$
( 78,119 )
Denominator:
Weighted average common shares outstanding
37,657
37,005
37,494
36,927
Net loss per share, basic and diluted
$
( 0.21 )
$
( 0.95 )
$
( 0.53 )
$
( 2.12 )
In periods when the Company is in a net loss position, dilutive securities are excluded from the computation of diluted earnings per share because their inclusion would have an anti-dilutive effect. Therefore, basic net loss per share is the same as diluted net loss per share.
The following common share equivalents have been excluded from the calculation of diluted net loss per share (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Common stock and RSUs
1,522
902
1,545
807
Stock options
2,760
2,503
2,793
2,423
Total anti-dilutive shares
4,282
3,405
4,338
3,230
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Note 11. Income Taxes
The Company’s effective tax rates were ( 2.7 )% and ( 3.0 %)% for the three and nine months ended September 30, 2023, respectively, and 0.2 % and less than 0.1 % for the three and nine months ended September 30, 2022, 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. Goodwill
During the third quarter of 2022, the Company identified certain indicators of impairment, including a significant decline in the Company’s stock price, actions taken under the Restructuring Plan (refer to Note 15 − Restructuring ), and a reduction of forecasted sales and profitability. As a result, the Company performed a goodwill impairment test and determined its goodwill was impaired as the carrying amount of the Company’s sole reporting unit exceeded its estimated fair value. The Company concluded that its entire goodwill balance was impaired and recognized an $ 8.2 million impairment charge during the third quarter of 2022.
As of September 30, 2023 and December 31, 2022, the Company had no remaining goodwill balance.
Note 13. Commitments and Contingencies
Purchase Commitments
Stratec
During the year ended December 31, 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. In 2022, Stratec shipped 75 thousand discs to the Company. In 2023, Stratec is required to ship no less than 220 thousand discs, 184 thousand of which have been shipped as of September 30, 2023. The total purchase commitment under the Stratec Supply Agreement is $ 3.7 million.
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. The Company’s total purchase commitments under these agreements as of September 30, 2023 were $ 4.7 million.
License Agreements
Harvard University
In August 2022, the Company and Harvard University (“Harvard”) entered into a 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 in August 2022, 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 and nine months ended September 30, 2023 and 2022.
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Refer to Note 14 − 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 contractually obligated 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 $ 1.3 million during the three and nine months ended September 30, 2023, respectively and $ 0.3 million and $ 1.1 million during the three and nine months ended September 30, 2022, respectively, which are recorded in cost of product revenue on the Consolidated Statements of Operations.
Refer to Note 14 − 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 accrues for 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 accrues the minimum amount of the range.
Leases
Operating lease obligations are recorded in operating lease liabilities and operating lease liabilities, net of current portion on the Consolidated Balance Sheets.
Future minimum lease payments under non-cancellable operating leases were as follows (in thousands):
Maturity of lease liabilities
As of September 30, 2023
2023 (remainder)
$
1,746
2024
7,064
2025
7,228
2026
7,408
2027
7,641
2028
7,880
Thereafter
15,741
Total lease payments
54,708
Less: imputed interest
12,309
Total operating lease liabilities
$
42,399
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.
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Note 14. Related Party Transactions
In June 2007, the Company and Tufts entered into the Tufts License Agreement for certain intellectual property owned by Tufts (refer to Note 13 − Commitments and Contingencies ). A member of the Company’s Board of Directors was previously affiliated with Tufts. This Board member continues to receive compensation from Tufts on a formulaic basis based on royalties and license payments the Company makes to Tufts. At September 30, 2023 and December 31, 2022, open payable balances to Tufts were not material.
A member of the Company’s Board of Directors is 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 totaled $ 0.3 million and $ 1.0 million for the three and nine months ended September 30, 2023, respectively. Revenue recorded from sales of products and services was no t material for the three months ended September 30, 2022, and $ 0.5 million for the nine months ended September 30, 2022.
Additionally, in August 2022, the Company and Harvard entered into the Harvard License Agreement for certain intellectual property owned by Harvard (refer to Note 13 − Commitments and Contingencies ). Harvard is obligated 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.
Cost of product revenue and operating expenses with Harvard and its affiliates and Mass General Brigham and its affiliates for the three and nine months ended September 30, 2023 and 2022 were not material. At September 30, 2023 and December 31, 2022, 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 to supply certain instruments and to grant certain licenses. 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. Cost of goods sold for both the three and nine months ended September 30, 2023 were not material. At September 30, 2023 and December 31, 2022, there were no open payable balances to UltraDx and open receivable balances from UltraDx were $ 0.4 million and zero , respectively.
Note 15. Restructuring
Following a strategic review and assessment of the Company’s operations and cost structure, on August 8, 2022, the Company announced a restructuring and strategic re-alignment plan (the “Restructuring Plan”). As part of the Restructuring Plan, the Company began an assay redevelopment program with the ultimate objective of improving its ability to manufacture and deliver high-quality assays at scale. The Restructuring Plan aligns the Company’s investments to best serve the needs of its customers, focuses the Company’s innovation efforts on key platforms, and provides a foundation for the Company’s entry into translational pharma and clinical markets, which it believes will be required to access new growth categories. In accordance with the Restructuring Plan, the Company implemented a workforce reduction, which was substantially completed by the end of the third quarter of 2022. The Restructuring Plan included the elimination of 119 positions and other cost-saving measures.
During the three and nine months ended September 30, 2022, the Company incurred approximately $ 3.4 million of expenses related to the Restructuring Plan, which were recorded in impairment and restructuring on the Consolidated Statements of Operations. These expenses were substantially for cash payments of severance and employee benefits, $ 3.1 million of which was paid by September 30, 2022.
Total restructuring expenses incurred in 2022 under the Restructuring Plan were $ 3.8 million.
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As a result of the Restructuring Plan, the Company performed an impairment assessment of its goodwill, long-lived assets, including operating lease right-of-use assets, and intangibles. The assessments resulted in the Company recording an impairment charge of $ 16.9 million during the three and nine months ended September 30, 2022, which was recorded in impairment and restructuring on the Consolidated Statements of Operations. The impairment charge included (1) $ 8.2 million of goodwill (refer to Note 12 − Goodwill ), (2) $ 7.7 million associated with the operating lease right-of-use asset and related property and equipment at leased facilities no longer being utilized, and (3) $ 1.0 million for software costs related to projects that were rationalized as part of the Restructuring Plan. During the nine months ended September 30, 2023, there were no material changes to the Restructuring Plan or the related exit and disposal costs.
The following table presents the restructuring reserve and provision activity for the nine months ended September 30, 2023 (in thousands):
Severance and Employee Benefit Costs
Balance at December 31, 2022
$
328
Accrual adjustments
( 33 )
Cash payments
( 16 )
Foreign currency translation
( 4 )
Balance at September 30, 2023
$
275
The Company did not have any restructuring activities or additional impairment charges related to the Restructuring Plan during the nine months ended September 30, 2023.
Note 16. 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.
As discussed in Note 3 − Revenue and Related Matters , during the second quarter of 2023 the Company received one million ordinary shares of UltraDx under the UltraDx Agreement. Primarily due to having less than a 5 % ownership interest in UltraDx, the Company concluded that it does not have the power to direct activities impacting UltraDx’s economic performance and therefore the Company is not the primary beneficiary of the VIE.
Based on the Company’s assessments, it does not have any controlling financial interests in any VIEs, and therefore did not consolidate any VIEs into its Consolidated Financial Statements during the three and nine months ended September 30, 2023 and 2022.
As of September 30, 2023 and December 31, 2022, the carrying value of the Company’s investment interests in VIEs was $ 1.1 million and $ 0.3 million, respectively, which are 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 these VIEs is limited to their carrying value and the Company does not have any future funding commitments to these VIEs.
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