Item 1. Financial Statements
Item 1. Financial Statements (Unaudited)
QUANTERIX CORPORATION
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except per share data)
June 30, 2023
December 31, 2022
ASSETS
Current assets:
Cash and cash equivalents
$
329,525
$
338,740
Accounts receivable (net of allowance for expected credit losses of $ 442 and $ 118 as of June 30, 2023 and December 31, 2022, respectively)
24,423
19,017
Inventory
18,156
16,786
Prepaid expenses and other current assets
6,954
6,860
Total current assets
379,058
381,403
Restricted cash
2,686
2,597
Property and equipment, net
18,328
20,162
Intangible assets, net
6,476
7,516
Operating lease right-of-use assets
20,380
21,223
Other non-current assets
2,282
1,298
Total assets
$
429,210
$
434,199
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$
3,238
$
3,836
Accrued compensation and benefits
7,525
10,658
Accrued expenses and other current liabilities
6,777
5,133
Deferred revenue
10,421
8,644
Operating lease liabilities
3,986
2,687
Total current liabilities
31,947
30,958
Deferred revenue, net of current portion
1,304
1,415
Operating lease liabilities, net of current portion
39,378
41,417
Other non-current liabilities
1,225
1,469
Total liabilities
73,854
75,259
Commitments and contingencies (Note 12)
Stockholders’ equity:
Common stock, $ 0.001 par value, per share:
Authorized shares: 120,000 ; Issued and outstanding: 37,566 and 37,280 shares at June 30, 2023 and December 31, 2022 , respectively
37
37
Additional paid-in capital
772,473
763,688
Accumulated other comprehensive loss
( 2,825 )
( 2,623 )
Accumulated deficit
( 414,329 )
( 402,162 )
Total stockholders’ equity
355,356
358,940
Total liabilities and stockholders’ equity
$
429,210
$
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 June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Revenues:
Product revenue
$
19,692
$
14,785
$
38,979
$
35,441
Service revenue
10,552
8,548
19,131
17,358
Collaboration and license revenue
629
92
997
178
Grant revenue
156
75
378
75
Total revenues
31,029
23,500
59,485
53,052
Costs of goods sold and services:
Cost of product revenue
7,236
9,921
14,269
20,667
Cost of service and other revenue
4,655
4,868
9,152
9,115
Total costs of goods sold and services
11,891
14,789
23,421
29,782
Gross profit
19,138
8,711
36,064
23,270
Operating expenses:
Research and development
5,946
6,625
10,666
13,659
Selling, general, and administrative
21,591
27,045
42,474
52,757
Other lease costs
1,162
—
1,938
—
Restructuring
—
—
( 33 )
—
Total operating expenses
28,699
33,670
55,045
66,416
Loss from operations
( 9,561 )
( 24,959 )
( 18,981 )
( 43,146 )
Interest income, net
3,886
552
7,335
604
Other expense, net
( 154 )
( 358 )
( 146 )
( 575 )
Loss before income taxes
( 5,829 )
( 24,765 )
( 11,792 )
( 43,117 )
Income tax (expense) benefit
( 235 )
( 137 )
( 375 )
62
Net loss
$
( 6,064 )
$
( 24,902 )
$
( 12,167 )
$
( 43,055 )
Net loss per common share, basic and diluted
$
( 0.16 )
$
( 0.67 )
$
( 0.33 )
$
( 1.17 )
Weighted-average common shares outstanding, basic and diluted
37,494
36,922
37,411
36,887
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 June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Net loss
$
( 6,064 )
$
( 24,902 )
$
( 12,167 )
$
( 43,055 )
Other comprehensive loss:
Foreign currency translation
( 244 )
( 1,447 )
( 202 )
( 2,644 )
Total other comprehensive loss
( 244 )
( 1,447 )
( 202 )
( 2,644 )
Comprehensive loss
$
( 6,308 )
$
( 26,349 )
$
( 12,369 )
$
( 45,699 )
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 June 30, 2023
Common stock
Shares
Value
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders' equity
Balance at March 31, 2023
37,424
$
37
$
768,141
$
( 2,581 )
$
( 408,265 )
$
357,332
Issuance of common stock under stock plans, including tax effects
142
—
139
—
—
139
Stock-based compensation expense
—
—
4,193
—
—
4,193
Foreign currency translation
—
—
—
( 244 )
—
( 244 )
Net loss
—
—
—
—
( 6,064 )
( 6,064 )
Balance at June 30, 2023
37,566
$
37
$
772,473
$
( 2,825 )
$
( 414,329 )
$
355,356
Three Months Ended June 30, 2022
Common stock
Shares
Value
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders' equity
Balance at March 31, 2022
36,899
$
37
$
750,742
$
( 756 )
$
( 323,615 )
$
426,408
Issuance of common stock under stock plans, including tax effects
76
—
211
—
—
211
Stock-based compensation expense
—
—
5,186
—
—
5,186
Foreign currency translation
—
—
—
( 1,447 )
—
( 1,447 )
Net loss
—
—
—
—
( 24,902 )
( 24,902 )
Balance at June 30, 2022
36,975
$
37
$
756,139
$
( 2,203 )
$
( 348,517 )
$
405,456
Six Months Ended June 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
286
—
690
—
—
690
Stock-based compensation expense
—
—
8,095
—
—
8,095
Foreign currency translation
—
—
—
( 202 )
—
( 202 )
Net loss
—
—
—
—
( 12,167 )
( 12,167 )
Balance at June 30, 2023
37,566
$
37
$
772,473
$
( 2,825 )
$
( 414,329 )
$
355,356
Six Months Ended June 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
207
—
1,190
—
—
1,190
Stock-based compensation expense
—
—
9,013
—
—
9,013
Foreign currency translation
—
—
—
( 2,644 )
—
( 2,644 )
Net loss
—
—
—
—
( 43,055 )
( 43,055 )
Balance at June 30, 2022
36,975
$
37
$
756,139
$
( 2,203 )
$
( 348,517 )
$
405,456
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)
Six Months Ended June 30,
2023
2022
Cash flows from operating activities:
Net loss
$
( 12,167 )
$
( 43,055 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
2,845
2,790
Credit losses on accounts receivable
324
581
Foreign currency losses
205
—
Operating lease right-of-use asset amortization
1,002
925
Stock-based compensation expense
8,095
9,013
Deferred income taxes
343
—
Loss on disposal of fixed assets
—
6
Changes in assets and liabilities:
Accounts receivable
( 5,750 )
3,479
Inventory
( 1,181 )
180
Prepaid expenses and other current assets
( 527 )
960
Other non-current assets
( 965 )
2
Accounts payable
( 631 )
( 3,220 )
Accrued compensation and benefits, accrued expenses, and other current liabilities
( 1,326 )
( 4,387 )
Deferred revenue
1,666
6,228
Operating lease liabilities
( 730 )
( 3,128 )
Other non-current liabilities
( 72 )
( 9 )
Net cash used in operating activities
( 8,869 )
( 29,635 )
Cash flows from investing activities:
Purchases of property and equipment
( 784 )
( 6,454 )
Proceeds from RADx grant on assets purchased
—
520
Net cash used in investing activities
( 784 )
( 5,934 )
Cash flows from financing activities:
Proceeds from common stock issued under stock plans
777
1,190
Payments for employee taxes withheld on stock-based compensation awards
( 87 )
—
Net cash provided by financing activities
690
1,190
Net decrease in cash, cash equivalents, and restricted cash
( 8,963 )
( 34,379 )
Effect of exchange rate changes on cash, cash equivalents, and restricted cash
( 163 )
( 776 )
Cash, cash equivalents, and restricted cash at beginning of period
341,337
399,042
Cash, cash equivalents, and restricted cash at end of period
$
332,211
$
363,887
Supplemental disclosure of cash flow information:
Cash paid for taxes
$
502
$
—
Operating lease right-of-use assets obtained in exchange for lease liabilities
$
—
$
22,376
Shares received as consideration under product sales agreement (Note 3)
$
1,000
$
—
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 through its CLIA-certified Accelerator Laboratory. The Accelerator Laboratory provides customers with access to Simoa technology and supports multiple projects and services, including sample testing, homebrew assay development, and custom assay development. To date, the Company has completed over 2,000 projects for more than 450 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 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 six months ended June 30, 2023 may not be indicative of the results for the full fiscal 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 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.
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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 loss within 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 six months ended June 30, 2023, and were $0.4 million during the six months ended 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 15 – 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 June 30,
2023
2022
Cash and cash equivalents
$
329,525
$
361,293
Restricted cash (1)
2,686
2,594
Cash, cash equivalents, and restricted cash
$
332,211
$
363,887
(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.
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.
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Note 3. Revenue and Related Matters
Disaggregated Revenue
The following tables disaggregate the Company’s revenue from contracts with customers by revenue type and geography (based on the location products and services are consumed) (in thousands):
Three Months Ended June 30, 2023
Three Months Ended June 30, 2022
North America
EMEA
Asia Pacific
Total
North America
EMEA
Asia Pacific
Total
Product revenue
Instruments
$
1,042
$
971
$
1,473
$
3,486
$
2,473
$
2,127
$
1,004
$
5,604
Consumable and other products
9,811
4,547
1,848
16,206
4,719
3,588
874
9,181
Total
$
10,853
$
5,518
$
3,321
$
19,692
$
7,192
$
5,715
$
1,878
$
14,785
Service revenue
Service-type warranties
$
1,559
$
753
$
153
$
2,465
$
1,320
$
688
$
124
$
2,132
Research services
6,321
711
453
7,485
5,511
316
8
5,835
Other services
372
219
11
602
317
237
27
581
Total
$
8,252
$
1,683
$
617
$
10,552
$
7,148
$
1,241
$
159
$
8,548
Collaboration and license revenue
$
629
$
—
$
—
$
629
$
43
$
49
$
—
$
92
Grant revenue
$
156
$
—
$
—
$
156
$
75
$
—
$
—
$
75
Total revenues
$
19,890
$
7,201
$
3,938
$
31,029
$
14,458
$
7,005
$
2,037
$
23,500
Six Months Ended June 30, 2023
Six Months Ended June 30, 2022
North America
EMEA
Asia Pacific
Total
North America
EMEA
Asia Pacific
Total
Product revenue
Instruments
$
3,186
$
2,952
$
2,607
$
8,745
$
4,638
$
4,173
$
3,015
$
11,826
Consumable and other products
17,268
9,487
3,479
30,234
13,552
8,014
2,049
23,615
Total
$
20,454
$
12,439
$
6,086
$
38,979
$
18,190
$
12,187
$
5,064
$
35,441
Service revenue
Service-type warranties
$
3,116
$
1,459
$
288
$
4,863
$
2,603
$
1,347
$
216
$
4,166
Research services
11,510
945
568
13,023
11,607
447
21
12,075
Other services
754
476
15
1,245
601
448
68
1,117
Total
$
15,380
$
2,880
$
871
$
19,131
$
14,811
$
2,242
$
305
$
17,358
Collaboration and license revenue
$
997
$
—
$
—
$
997
$
43
$
83
$
52
$
178
Grant revenue
$
378
$
—
$
—
$
378
$
75
$
—
$
—
$
75
Total revenues
$
37,209
$
15,319
$
6,957
$
59,485
$
33,119
$
14,512
$
5,421
$
53,052
For each of the three and six months ended June 30, 2023, one customer accounted for more than 10 % of the Company’s total revenues. At June 30, 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
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components, and granted a co-exclusive license to manufacture, seek Chinese regulatory approval of (including performance of any necessary research and development activities), and commercialize, HD-X instruments assembled in China and related assays in the Chinese neurological in vitro diagnostic market. Refer to Note 13 – Related Party Transactions for a discussion of the related party relationships between Quanterix and these entities.
The 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.
During the three months ended June 30, 2023, UltraDx completed the qualified preferred share financing and issued to the Company one million ordinary shares with a total fair value of $ 1.0 million. Refer to Note 5 – Fair Value of Financial Instruments for the Company’s disclosures related to determining the fair value of the shares received. Also refer to Note 15 – Variable Interest Entities for additional information on the Company’s investment interests in UltraDx as a result of the share issuance.
During the three and six months ended June 30, 2023, the Company recognized $ 1.4 million of revenue, which includes the one-time revenue from the receipt of the UltraDx shares. During the three and six months ended June 30, 2022, no revenue was recognized under the UltraDx Agreement.
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 June 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 $ 3.0 million during the three and six months ended June 30, 2023, respectively, and $ 2.7 million and $ 5.4 million during the three and six months ended June 30, 2022, respectively.
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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 the terms of the Abbott License Agreement, the Company granted Abbott a non-exclusive, worldwide, royalty-bearing license, without the right to sublicense, under the Company’s bead-based single molecule detection patent (the “Licensed Patents”) in the field of in vitro diagnostics. Abbott agreed to pay the Company an initial license fee of $ 10.0 million in connection with the execution of the Abbott License Agreement, 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 six months ended June 30, 2023, the Company recognized $ 0.5 million of one-time revenue 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.
NIH Grant
On September 21, 2022, the Company and the National Institutes of Health (the “NIH”) entered into a contract (the “NIH Grant”) with a total award value of $ 1.7 million. The NIH is an agency of the U.S. Department of Health and Human Services and granted the Company funding in support of the development of certain point-of-care diagnostic technologies through collaborative efforts. Grant funding is to be used solely for activities related to the point-of-care diagnostic device development project and the contract period runs through August 2025. Receipt of the award value occurs throughout the term of the contract period and after the Company submits for reimbursement of activities related to the grant. As of June 30, 2023, the Company had not received any of the award value.
During the three and six months ended June 30, 2023, grant revenue recognized and research and development expenses incurred were immaterial.
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 June 30, 2023, the Company had received the total funding value of $ 2.3 million.
During the three and six months ended June 30, 2023 and 2022, grant revenue recognized and research and development expenses incurred were immaterial.
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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 three months ended June 30, 2022, the Company received $ 0.5 million which represented the final and total funding value of the $ 18.2 million award.
During both the three and six months ended June 30, 2022, the Company recognized no grant revenue and incurred no research and development expenses. As of June 30, 2022, the Company had no future obligations under the RADx Grant.
Contract Assets and Liabilities
There were no contract assets of as June 30, 2023 or December 31, 2022.
Deferred Revenue
The Company refers to contract liabilities as deferred revenue on the Consolidated Balance Sheets . During the six months ended June 30, 2023 and 2022, the Company recognized $ 4.9 million and $ 3.6 million of revenue, respectively related to its deferred revenue balance at January 1 of each such period.
Remaining Performance Obligations
As of June 30, 2023, the aggregate amount of transaction price allocated to performance obligations that have not yet been satisfied, or are partially satisfied, was $ 11.7 million.
Of the performance obligations not yet satisfied or partially satisfied, $ 10.4 million is expected to be recognized as revenue in the next 12 months , with the remainder expected to be recognized within the 24 months thereafter. The $ 10.4 million principally 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
335
632
Amortization of costs to obtain a contract
( 333 )
( 662 )
Balance at June 30
$
379
$
410
Costs to obtain a contract are amortized to earnings over the estimated 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 six months ended June 30, 2023 or 2022.
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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.
Customers are assessed for credit worthiness upfront through a credit review, which includes analysis of customers’ financial statements when a credit rating is not available.
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
516
581
Write-offs and recoveries collected
( 192 )
—
Balance at June 30
$
442
$
1,000
Note 5. Fair Value of Financial Instruments
Recurring Fair Value Measurements
The following tables present the Company’s fair value hierarchy for its financial assets that are measured at fair value on a recurring basis (in thousands):
As of June 30, 2023
Total
Quoted prices in active markets (Level 1)
Significant other observable inputs (Level 2)
Significant unobservable inputs (Level 3)
Financial assets:
Cash equivalents - money market funds
$
312,986
$
312,986
$
—
$
—
Total Financial Assets
$
312,986
$
312,986
$
—
$
—
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:
Cash equivalents - money market funds
$
306,097
$
306,097
$
—
$
—
Total Financial Assets
$
306,097
$
306,097
$
—
$
—
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 is minimal market activity or other financial information available to determine the fair value of UltraDx’s shares and therefore this investment is considered a Level 3 financial asset. 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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As of June 30, 2023 and December 31, 2022, the carrying value of the Company’s Level 3 financial assets was $ 1.3 million and $ 0.3 million, respectively. There were no changes in the carrying value of these assets during the three and six months ended June 30, 2023 and 2022. These assets are included in other non-current assets on the Consolidated Balance Sheets. Refer to Note 15 – Variable Interest Entities for further discussion.
Other Fair Value Disclosures
During the six months ended June 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 3 financial assets.
Note 6. Inventory
Inventory, net of inventory reserves, consisted of the following (in thousands):
June 30, 2023
December 31, 2022
Raw materials
$
4,966
$
5,509
Work in process
5,520
3,362
Finished goods
7,670
7,915
Total inventory
$
18,156
$
16,786
Note 7. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
June 30, 2023
December 31, 2022
Accrued professional services
$
1,853
$
1,409
Accrued royalties
1,167
815
Accrued tax liabilities
918
172
Accrued in-transit inventory
594
21
Other accrued expenses
2,245
2,716
Total accrued expenses and other current liabilities
$
6,777
$
5,133
Note 8. Stock-Based Compensation
Stock Options
Stock option activity for the six months ended June 30, 2023 is presented below (in thousands, except per share and contractual life amounts):
Weighted-average
Weighted-average remaining
Aggregate
Number of shares
exercise price per share
contractual life (in years)
intrinsic value
Outstanding at December 31, 2022
2,188
$
20.69
8.1
$
4,273
Granted
1,006
14.91
Exercised
( 44 )
6.74
Cancelled
( 355 )
17.11
Outstanding at June 30, 2023
2,795
$
19.28
8.2
$
18,118
Exercisable at June 30, 2023
918
$
24.67
6.0
$
3,740
Vested and expected to vest at June 30, 2023
2,795
$
19.28
8.2
$
18,118
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Restricted Stock Units
Restricted stock unit (“RSU”) activity for the six months ended June 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
737
14.58
Vested
( 171 )
30.87
Cancelled
( 223 )
17.37
Unvested RSUs at June 30, 2023
1,531
$
17.47
9.3
$
34,515
Expected to convert at June 30, 2023
1,531
$
17.47
9.3
$
34,515
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 fiscal year 2018. The increase is equal to the lowest 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 six months ended June 30, 2023, employees purchased 70 thousand shares of the Company’s common stock pursuant to the 2017 ESPP.
Stock-Based Compensation Expense
Stock-based compensation expense was recorded in the following categories on the Consolidated Statements of Operations (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Cost of product revenue
$
200
$
137
$
387
$
225
Cost of service and other revenue
258
205
608
371
Research and development
405
482
775
880
Selling, general, and administrative
3,330
4,362
6,325
7,537
Total stock-based compensation
$
4,193
$
5,186
$
8,095
$
9,013
As of June 30, 2023, there was $ 39.8 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 2.9 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 June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Stock Options:
Risk-free interest rate
3.5 % - 4.2 %
2.7 % - 3.2 %
3.5 % - 4.2 %
1.4 % - 3.2 %
Expected dividend yield
—
—
—
—
Expected term (in years)
5.0 - 5.1
5.7 - 5.8
5.0 - 5.1
5.7 - 5.8
Expected volatility
80.9 % - 82.1 %
55.1 % - 56.2 %
71.1 % - 82.1 %
55.0 % - 56.2 %
Weighted-average grant date fair value
$
11.95
$
13.47
$
9.62
$
14.11
Employee Stock Purchase Plan:
Risk-free interest rate
5.2 %
1.1 %
5.2 %
0.7 % - 1.1 %
Expected dividend yield
—
—
—
—
Expected term (in years)
0.5
0.5
0.5
0.5
Expected volatility
72.8 %
55.7 %
72.8 % - 82.5 %
51.9 % - 55.7 %
Weighted-average grant date fair value
$
2.25
$
4.62
$
2.24
$
4.76
Note 9. Net Loss Per Share
The following table presents the computation of basic and diluted net loss per share (in thousands, except per share data):
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Numerator:
Net loss
$
( 6,064 )
$
( 24,902 )
$
( 12,167 )
$
( 43,055 )
Denominator:
Weighted average common shares outstanding
37,494
36,922
37,411
36,887
Net loss per share, basic and diluted
$
( 0.16 )
$
( 0.67 )
$
( 0.33 )
$
( 1.17 )
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 June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Common stock and RSUs
1,607
928
1,557
759
Stock options
2,891
2,578
2,810
2,383
Total anti-dilutive shares
4,498
3,506
4,367
3,142
Note 10. Income Taxes
The Company’s effective tax rates were 4.0 % and 3.2 % for the three and six months ended June 30, 2023, respectively, and 0.0 % for each of the three and six months ended June 30, 2022. 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.
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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 11. 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 14 - 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 non-cash impairment charge during the third quarter of 2022.
As of June 30, 2023 and December 31, 2022, the Company had no remaining goodwill balance.
Note 12. 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 515,000 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 75,000 discs to the Company and Stratec is required to ship no less than 220,000 discs in 2023. The total purchase commitment under the Stratec Supply Agreement is $ 3.7 million.
Other Purchase Commitments
The Company purchases raw materials for manufacturing operations under annual and multi-year agreements, some of which have minimum quantity requirements. Additionally, the Company enters into annual agreements for other parts of its operations. The Company’s total purchase commitments under these agreements as of June 30, 2023 was $ 2.6 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, 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 six months ended June 30, 2023, and 2022.
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
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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 recorded royalty expense related to the Tufts License Agreement of $ 0.4 million and $ 0.8 million during the three and six months ended June 30, 2023, respectively and $ 0.4 million and $ 0.7 million during the three and six months ended June 30, 2022, respectively. This royalty expense is 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 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 June 30, 2023
2023 (remainder)
$
3,487
2024
7,064
2025
7,228
2026
7,408
2027
7,641
2028
7,880
Thereafter
15,741
Total lease payments
$
56,449
Less: imputed interest
13,085
Total operating lease liabilities
$
43,364
The Company’s lease agreement for office and lab 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 and Tufts 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. 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 June 30, 2023 and December 31, 2022, open payable balances to Tufts were immaterial.
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 $ 0.5 million and $ 0.7 million for the three and six months ended June 30, 2023, respectively, and was immaterial for the three and six months ended June 30, 2022.
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Additionally, in August 2022, the Company and Harvard entered into the Harvard License Agreement for certain intellectual property owned by Harvard (refer to Note 12 – 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 six months ended June 30, 2023 and 2022 was immaterial. At June 30, 2023 and December 31, 2022, open payables to and receivable balances from Harvard and Mass General Brigham were immaterial.
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 six months ended June 30, 2023 were immaterial. At June 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 14. 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.
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 $ 25.6 million during the year ended December 31, 2022. The impairment charge included (1) $ 16.3 million associated with the operating lease right-of-use asset and related property and equipment at leased facilities, (2) $ 8.2 million of goodwill (refer to Note 11 – Goodwill ), and (3) $ 1.1 million for software costs related to projects that were rationalized as part of the Restructuring Plan. There were no impairment charges recorded associated with the Restructuring Plan during the three and six months ended June 30, 2023. There were no material changes to the Restructuring Plan or the exit and disposal costs in 2023.
The following table presents the restructuring reserve and provision activity for the six months ended June 30, 2023 (in thousands):
Severance and Employee Benefit Costs
Balance at December 31, 2022
$
328
Accrual adjustments
( 33 )
Cash payments
( 16 )
Foreign currency translation
5
Balance at June 30, 2023
$
284
The Company did not have any restructuring activities during the six months ended June 30, 2022.
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Note 15. 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 six months ended June 30, 2023 and 2022.
As of June 30, 2023 and December 31, 2022, the carrying value of the Company’s investment interests in VIEs was $ 1.3 million and $ 0.3 million, respectively, which are recorded in other non-current assets on the Consolidated Balance Sheets. Refer to Note 5 – 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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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.