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QTRX on Nasdaq

Quanterix (United States)

Logo: quanterix.com3

In its 2026 annual report the company says: “We are a life sciences company transforming healthcare innovation by accelerating biomarker breakthroughs from discovery to diagnostics using our ultra-sensitive translational research and spatial biology instruments, consumables, and services. We continue to invest in pushing a paradigm shift in healthcare from an emphasis on later-stage treatment to a focus on earlier detection, monitoring, prognosis, and, ultimately, prevention.”6 It was founded in 2007.1 It is headquartered in Lexington.1 Its shares trade on Nasdaq under the symbol QTRX.1

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Last updated Oct 21, 2026.

Overview

2007Founded1

Compare with Pacific Biosciences, Cytek Biosciences, Inc. or Harvard Bioscience, or pick any stock.

  • TickerQTRX on Nasdaq1
  • IndustryLaboratory Analytical Instruments1
  • HeadquartersLexington1
  • Websitewww.quanterix.com
  • Incorporated inDE4
  • Business address900 Middlesex Turnpike, Billerica, Ma 018214
  • Filer categoryAccelerated filer4

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We are a life sciences company transforming healthcare innovation by accelerating biomarker breakthroughs from discovery to diagnostics using our ultra-sensitive translational research and spatial biology instruments, consumables, and services. We continue to invest in pushing a paradigm shift in healthcare from an emphasis on later-stage treatment to a focus on earlier detection, monitoring, prognosis, and, ultimately, prevention. Our combined platforms have achieved significant commercial adoption with an installed base of over 2,500 instruments and scientific validation with citations in more than 6,200 scientific publications in areas of high unmet medical need and research interest such as neurology, oncology, immunology, and inflammation.6 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

46.8%Gross margin7
-90.4%Operating margin7
-77.1%Net margin7
1.1%Revenue growth, 20257
-36.2%Return on equity7
-$79.8MFree cash flow7

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Simoa Service And Other Revenue brought in 25% of the revenue Quanterix (United States) broke down this way in fiscal 2025.

  1. Simoa Service And Other Revenue$32.4M725%down 37% from 2024
  2. Research Services$26.0M720%down 32% from 2024
  3. Spatial Product Revenue$21.9M717%
  4. Instruments$17.9M714%up 70% from 2024
  5. Spatial Service And Other Revenue$11.8M79%
  6. Service-type warranties$11.1M79%up 5% from 2024
  7. Other Services$7.1M75%up 169% from 2024
  8. License and Service$1.5M71%down 66% from 2024
  9. Grant$243.0K70%down 88% from 2024
Products and services by year
Products and services202320242025
Simoa Service And Other Revenue$40.1M$51.2M$32.4M
Research Services$27.8M$38.0M$26.0M
Spatial Product Revenue$0$0$21.9M
Instruments$15.7M$10.5M$17.9M
Spatial Service And Other Revenue$0$0$11.8M
Service-type warranties$9.9M$10.6M$11.1M
Other Services$2.4M$2.6M$7.1M
License and Service$1.4M$4.5M$1.5M
Grant$1.2M$2.0M$243.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue29¢$73.9M
  • Research and development14¢$35.9M
  • Selling, general and admin55¢$138.0M
  • Income tax2¢$5.1M

Out of $138.9M in revenue.7 The company lost money this year.

Financial statements

Revenue8910117$138.9M in 2025+145% since 2019
0$50.0M$100.0M$150.0M2019: $56.7M$56.7M20192020: $86.4M$86.4M2020+52%2021: $110.6M$110.6M2021+28%2022: $105.5M$105.5M2022−5%2023: $122.4M$122.4M2023+16%2024: $137.4M$137.4M2024+12%2025: $138.9M$138.9M2025+1%
Gross profit8910117$65.0M in 2025+142% since 2019
0$25.0M$50.0M$75.0M$100.0M2019: $26.8M$26.8M20192020: $48.2M$48.2M2020+80%2021: $64.8M$64.8M2021+34%2022: $45.4M$45.4M2022−30%2023: $74.2M$74.2M2023+64%2024: $83.1M$83.1M2024+12%2025: $65.0M$65.0M2025−22%
Operating income8910117-$125.5M in 2025+202% since 2019
-$150.0M-$100.0M-$50.0M02019: -$41.6M-$41.6M20192020: -$31.6M-$31.6M2020−24%2021: -$56.5M-$56.5M2021+79%2022: -$104.3M-$104.3M2022+84%2023: -$46.0M-$46.0M2023−56%2024: -$52.6M-$52.6M2024+14%2025: -$125.5M-$125.5M2025+139%
Net income8910117-$107.2M in 2025+163% since 2019
-$150.0M-$100.0M-$50.0M02019: -$40.8M-$40.8M20192020: -$31.5M-$31.5M2020−23%2021: -$55.5M-$55.5M2021+76%2022: -$99.6M-$99.6M2022+79%2023: -$28.4M-$28.4M2023−72%2024: -$38.5M-$38.5M2024+36%2025: -$107.2M-$107.2M2025+178%

Every line of the income statement as filed: the last 3 fiscal years, latest first.7

Period ending2025-12-312024-12-312023-12-31
Total revenues$138.9M$137.4M$122.4M
Total costs of goods sold and services$73.9M$54.3M$48.1M
Gross profit$65.0M$83.1M$74.2M
Research and development$35.9M$31.1M$26.1M
Selling, general and administrative$138.0M$101.6M$89.1M
Other lease costs$844.0K$3.0M$3.7M
Impairment and restructuring$15.7M$0$1.3M
Total operating expenses$190.5M$135.7M$120.2M
Loss from operations-$125.5M-$52.6M-$46.0M
Interest income$8.6M$14.7M$15.8M
Change in fair value of contingent liabilities-$4.5M$0$0
Other income (expense), net$157.0K-$136.0K$2.5M
Loss before income taxes-$112.3M-$38.1M-$27.6M
Income tax benefit (expense)$5.1M-$434.0K-$719.0K
Net loss-$107.2M-$38.5M-$28.4M
Net loss per common share, basic (in dollars per share)-$2.51-$1.00-$0.75
Net loss per share, diluted (in dollars per share)-$2.51-$1.00-$0.75
Weighted-average common shares outstanding, basic (in shares)42.6M shares38.4M shares37.6M shares
Weighted-average common shares outstanding, diluted (in shares)42.6M shares38.4M shares37.6M shares

Compare Quanterix (United States) with another company

Corporate structure

Quanterix (United States) sits at the top of its group. 11 entities, 6 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Quanterix (United States)

  • Quanterix (United States) Lexington
    • Akoya Biosciences, Inc. Stake · Marlborough, Massachusetts
    • Akoya Biosciences UK Ltd. Subsidiary · United Kingdom
    • Akoya Biosciences, Inc. Subsidiary · Delaware, United States
    • Aushon Biosystems, Inc. Subsidiary · Delaware, United States
    • Emission Inc. Subsidiary · Delaware, United States
    • Quanterix Bio-tech (Shanghai) Co., Ltd Subsidiary · China
    • Quanterix Holdings (Hong Kong) Limited Subsidiary · Hong Kong
    • Quanterix Netherlands B.V. Subsidiary · Netherlands
    • Quanterix Security Corporation Subsidiary · Massachusetts, United States
    • UmanDiagnostics AB Subsidiary · Sweden

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G; stakes of 5% or more it reported on Schedules 13D and 13G (1 companies). Each entity in the chart links to its source.

What it owns

What Quanterix (United States) reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$49.5M7 Dec 31, 2025$36.0M7 Dec 31, 2024+37.6%
Accumulated depreciation$25.8M7 Dec 31, 2025$18.8M7 Dec 31, 2024+37.2%
Property and equipment, net$23.7M7 Dec 31, 2025$17.1M7 Dec 31, 2024+38.0%
Operating-lease assets (leased space)$16.7M7 Dec 31, 2025$16.3M7 Dec 31, 2024+2.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$29.8M7 Dec 31, 2025$56.7M7 Dec 31, 2024−47.4%
Marketable securities, current$88.4M7 Dec 31, 2025$232.4M7 Dec 31, 2024−62.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$26.4M7 Dec 31, 2025$07 Dec 31, 2024
Intangible assets, net (excluding goodwill)$131.8M7 Dec 31, 2025$4.0M7 Dec 31, 2024+3169.3%
Finite-lived intangibles, gross$131.8M7 Dec 31, 2025$16.4M7 Dec 31, 2024+703.7%
Accumulated amortization$17.8M7 Dec 31, 2025$10.2M7 Dec 31, 2024+74.8%
Finite-lived intangibles, net$112.5M7 Dec 31, 2025$4.0M7 Dec 31, 2024+2690.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$54.8M7 Dec 31, 2025$32.8M7 Dec 31, 2024+67.1%
Raw materials$13.7M7 Dec 31, 2025$7.2M7 Dec 31, 2024+90.3%
Work in process$11.0M7 Dec 31, 2025$8.0M7 Dec 31, 2024+38.2%
Finished goods$30.0M7 Dec 31, 2025$17.6M7 Dec 31, 2024+70.7%

Properties, in its own words

Our corporate headquarters is currently located in Billerica, Massachusetts, which consists of an approximately 91,600 square foot facility we lease for office and manufacturing purposes. We also lease office and laboratory space domestically in Bedford and Marlborough, Massachusetts and Georgetown, Texas, and internationally in the Netherlands, Sweden, and China. We do not currently occupy one of our Bedford facilities or two of the facilities acquired from Akoya (in Menlo Park, California and Marlborough, Massachusetts) and currently sublease a portion of these facilities.

We believe our facilities are adequate and suitable for our current operations and that, should it be needed, additional or alternative space is available to accommodate our operations.

Item 2 of the 10-K filed Mar 2, 2026.6

Leadership

Who has led Quanterix (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. E. Kevin Hrusovsky2017–2022
  2. Masoud Toloue2022–2026
  3. Everett Cunningham2026–now

Chair

  1. E. Kevin Hrusovsky2018–2022
  2. William P. Donnelly2025–now

President

  1. E. Kevin Hrusovsky2017–2021
  2. Masoud Toloue2021–2026
  3. Everett Cunningham2026–now

Chief financial officer

  1. Joseph Driscoll2017–2019
  2. Amol Chaubal2019–2021
  3. Shawn Stetson2021
  4. Michael A. Doyle2021–2023
  5. Vandana Sriram2023–2026
  6. Jason F. Faessler2026–now

Chief operating officer

  1. William Geist2020–2021
  2. Michael Francis Miller2026–now
2010201520202025
Board members and other officers (32)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Akoya Biosciences UK Ltd. United Kingdom5
  • Akoya Biosciences, Inc. Delaware5
  • Aushon Biosystems, Inc. Delaware5
  • Emission Inc. Delaware5
  • Quanterix Bio-tech (Shanghai) Co., Ltd China5
  • Quanterix Holdings (Hong Kong) Limited Hong Kong5
  • Quanterix Netherlands B.V. The Netherlands5
  • Quanterix Security Corporation Massachusetts5
  • UmanDiagnostics AB Sweden5

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Aug 10, 20268-K Results of operations; Regulation FD disclosure58
  2. Jun 10, 20268-K Shareholder vote59
  3. Jun 9, 20268-K Executive or director change; Regulation FD disclosure60
  4. May 26, 20268-K Executive or director change61
  5. May 12, 20268-K Executive or director change; Regulation FD disclosure62
  6. May 6, 20268-K Results of operations; Regulation FD disclosure63
  7. Mar 2, 20268-K Results of operations64
  8. Jan 21, 2026New chief executive Everett Cunningham becomes CEO15
  9. Jan 8, 20268-K Results of operations; Executive or director change; Regulation FD disclosure65
  10. Nov 20, 20258-K Executive or director change; Regulation FD disclosure66
  11. Nov 10, 20258-K Results of operations67
  12. Oct 2, 20258-K Shareholder vote68
  13. Sep 24, 20258-K Shareholder vote; Regulation FD disclosure69
  14. Apr 27, 2022New chief executive Masoud Toloue becomes CEO16
  15. Dec 6, 2017New chief executive E. Kevin Hrusovsky becomes CEO17
  16. 2007Founded Founded1

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/202670

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results58
  2. May 6, 2026Reported quarterly or annual results63
  3. Mar 2, 2026Reported quarterly or annual results64
  4. Jan 8, 2026Reported quarterly or annual results65
  5. Nov 10, 2025Reported quarterly or annual results67
  6. Aug 7, 2025Reported quarterly or annual results71
  7. May 12, 2025Reported quarterly or annual results72
  8. Mar 17, 2025Reported quarterly or annual results73

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

540 filings to the SEC since October 2021: 7 annual reports, 17 quarterly reports, 73 major events, 321 insider forms, 44 large holders, 78 other. The latest 20:

  1. Oct 2, 20264 PRIMARY DOCUMENT EDGAR
  2. Oct 2, 20264 PRIMARY DOCUMENT EDGAR
  3. Oct 2, 20264 PRIMARY DOCUMENT EDGAR
  4. Sep 17, 20264 PRIMARY DOCUMENT EDGAR
  5. Sep 16, 20264 PRIMARY DOCUMENT EDGAR
  6. Sep 11, 2026S-8 EDGAR
  7. Sep 1, 20264 PRIMARY DOCUMENT EDGAR
  8. Aug 20, 20264 PRIMARY DOCUMENT EDGAR
  9. Aug 19, 20263 PRIMARY DOCUMENT EDGAR
  10. Aug 19, 20264 PRIMARY DOCUMENT EDGAR
  11. Aug 17, 20264 PRIMARY DOCUMENT EDGAR
  12. Aug 14, 20264 PRIMARY DOCUMENT EDGAR
  13. Aug 14, 2026SCHEDULE 13G/A EDGAR
  14. Aug 10, 202610-Q EDGAR
  15. Aug 10, 20268-K EDGAR
  16. Aug 6, 2026SCHEDULE 13G EDGAR
  17. Aug 4, 20264 PRIMARY DOCUMENT EDGAR
  18. Jul 16, 20264 PRIMARY DOCUMENT EDGAR
  19. Jul 16, 20264 PRIMARY DOCUMENT EDGAR
  20. Jul 9, 20264 PRIMARY DOCUMENT EDGAR

The 540 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

79 open-market trades by officers, directors and large owners since October 2021: 20 buys and 59 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 13, 2026DONNELLY WILLIAM PDirectorBuy72,245$2.93$211.7KForm 4
Aug 12, 2026DONNELLY WILLIAM PDirectorBuy27,155$2.75$74.7KForm 4
May 12, 2026Meadows BenjaminChief Commercial OfficerBuy3,500$2.77$9.7KForm 4
Sep 12, 2025Sriram VandanaChief Financial OfficerBuy4,150$4.79$19.9KForm 4
Jun 13, 2025WALT DAVID RDirectorBuy123,990$6.14$761.3KForm 4
Jun 12, 2025WALT DAVID RDirectorBuy36,010$6.23$224.3KForm 4
Jun 9, 2025Toloue MasoudPresident & CEOBuy45,900$5.42$248.8KForm 4
Jun 9, 2025WALT DAVID RDirectorBuy78,131$5.34$417.2KForm 4
Jun 6, 2025WALT DAVID RDirectorBuy131,869$5.43$716.0KForm 4
Jun 6, 2025DONNELLY WILLIAM PDirectorBuy93,113$5.44$506.5KForm 4
Aug 20, 2024WALT DAVID RDirectorBuy47,000$13.29$624.6KForm 4
Aug 13, 2024Toloue MasoudPresident & CEOBuy19,000$10.90$207.1KForm 4
May 14, 2024OLSON LAURIE JDirectorSale1,500$16.98$25.5KForm 4
Apr 1, 2024OLSON LAURIE JDirectorSale1,000$23.50$23.5KForm 4
Feb 14, 2024OLSON LAURIE JDirectorSale1,500$24.35$36.5KForm 4
Jan 2, 2024OLSON LAURIE JDirectorSale1,000$26.91$26.9KForm 4
Nov 14, 2023OLSON LAURIE JDirectorSale1,500$21.89$32.8KForm 4
Sep 8, 2023DONNELLY WILLIAM PDirectorBuy20,200$24.85$502.0KForm 4
Aug 15, 2022DOYLE MICHAEL ACFO and TreasurerBuy15,000$10.16$152.4KForm 4
Aug 12, 2022DOYLE MICHAEL ACFO and TreasurerBuy15,000$10.43$156.4KForm 4

All 79 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Stakes it holds

Quanterix (United States) has told the SEC it owns more than 5% of 1 company, latest first (Schedules 13D and 13G).

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Masoud Toloue, Ph.D.Former President and Chief Executive Officer$671.0K$5.3M89
2025Vandana Sriram Chief Financial Officer and Treasurer52$462.3K$2.2M89
2025William P. Donnelly Former Executive Chair64$19.3K$596.8K89
2024Masoud Toloue, Ph.D.Former President and Chief Executive Officer$642.8K$6.4M89
2024Vandana Sriram Chief Financial Officer and Treasurer52$446.2K$2.6M89
2023Masoud Toloue, Ph.D.Former President and Chief Executive Officer$615.4K$5.4M89
2023Vandana Sriram Chief Financial Officer and Treasurer52$144.1K$1.1M89

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
First Eagle Investment Management, LLC5,506,330$23.8M0.0%+4,206,243
BlackRock, Inc.3,635,411$15.7M0.0%+357,816
Blue Water Life Science Advisors, LP3,474,202$15.0M9.5%+1,332,055
Portolan Capital Management, LLC1,899,308$8.2M0.3%−1,046,515
Vanguard Capital Management LLC1,800,644$7.8M0.0%+16,031
Lionhunter Capital Management, LLC1,500,427$6.5M2.9%New
Aqr Capital Management LLC1,343,005$5.8M0.0%+1,258,873
Geode Capital Management, LLC1,131,377$4.9M0.0%+136,613
Ameriprise Financial Inc987,424$4.3M0.0%−2,554,950
Marshall Wace, Llp973,872$4.2M0.0%+351,492
State Street Corp932,307$4.0M0.0%+34,030
Tikvah Management LLC571,555$2.5M0.8%−64
Vanguard Portfolio Management LLC489,566$2.1M0.0%−87,034
Jacobs Levy Equity Management, Inc487,600$2.1M0.0%New
Morgan Stanley447,688$1.9M0.0%−160,168
Jane Street Group, LLC419,050$1.8M0.0%+263,395
Tudor Investment Corp Et Al400,402$1.7M0.0%+84,401
Dimensional Fund Advisors LP397,833$1.7M0.0%−45,285
Northern Trust Corp337,227$1.5M0.0%−12,431
Charles Schwab Investment Management Inc310,701$1.3M0.0%−35,212
Vanguard Fiduciary Trust Co288,311$1.2M0.0%+17,782
UBS Group AG281,978$1.2M0.0%−95,004
Nuveen, LLC232,592$1.0M0.0%+160,750
Citadel Advisors LLC229,736$992.5K0.0%+168,735
XTX Topco Ltd228,035$985.1K0.0%+116,375

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Quanterix (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARQuanterix Corp2
  • CIK0001503274
  • Employer ID (EIN)20-89579886
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)3826 Laboratory Analytical Instruments2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address900 Middlesex Turnpike, Billerica, MA 018212
  • Phone617-301-94002
  • Shares outstanding47,293,065 as of Aug 3, 202613
  • Public float$239.0M as of Jun 30, 20256
  • AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; it also attests to the company’s internal control over financial reporting6
  • On EDGAR sinceOct 12, 20102
  • Filings1,079 in all: 4 (660), 8-K (120), 3 (44), 10-Q (26), SC 13G/A (23), SCHEDULE 13G/A (16), SC 13G (15), S-8 (13)2
    All 52 form types

    425 (12), CORRESP (11), DEFA14A (11), DFAN14A (11), 10-K (9), DEF 14A (9), UPLOAD (9), 4/A (7), 424B5 (7), D (7), 144 (4), 8-K/A (4), ARS (4), DRS/A (4), EFFECT (4), SCHEDULE 13D/A (4), SCHEDULE 13G (4), 10-K/A (3), DRSLTR (3), S-4/A (3), SCHEDULE 13D (3), 10-Q/A (2), 424B3 (2), POS AM (2), S-1/A (2), SD (2), SEC STAFF LETTER (2), 424B4 (1), 8-A12B (1), CERT (1), CT ORDER (1), DEFC14A (1), DRS (1), NT 10-Q (1), PRE 14A (1), PREC14A (1), S-1 (1), S-1MEF (1), S-3 (1), S-3/A (1), S-3ASR (1), S-3MEF (1), S-4 (1), S-8 POS (1)

  • Latest filingsAnnual report (10-K) Mar 2, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Aug 10, 2026

Securities registered for trading

ClassSymbolExchange
QTRXThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 2, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Quanterix (United States) names in Item 1A of its 10-K filed Mar 2, 2026: 44 risks under these headings, as written.6

  • Risks Related to our Financial Condition and Financial Reporting Matters
  • Our quarterly and annual operating results and cash flows have fluctuated in the past, and our operating results may continue to fluctuate, which could cause the value of our common stock to fluctuate or decline significantly.
  • We have incurred annual losses since our formation, and we expect to incur losses in the future. We cannot be certain that we will achieve or sustain profitability.
  • Inherent limitations associated with, our internal control over financial reporting could result in material misstatements in our financial statements.
  • Our ability to use net operating losses to offset future income may be subject to certain limitations.
  • Risks Related to our Business
  • Combining the businesses of Quanterix and Akoya may be more difficult, costly or time-consuming than expected and we may fail to realize the anticipated benefits of the acquisition, which may adversely affect our business results and negatively affect the value of our common stock.
  • We may fail to achieve the remaining expected cost savings and related benefits from our cost reduction actions, and the consequences of those actions may adversely impact our business.
  • Recent transitions in our board of directors and management could result in changes in our strategic plan, product focus, and investment priorities, and we might not realize the anticipated benefits from any such changes.
  • If our products fail to achieve and sustain sufficient market acceptance, our revenue will be adversely affected.
  • Sales of our Simoa-based assays for neurological indications have become increasingly important to our business, and there can be no assurance that we will be able to continue to generate meaningful revenues from the sale of such products.
  • We may not be successful in penetrating the diagnostics market.
The other 34 risks
  • The sales cycle for our instruments can be lengthy and variable, which makes it difficult for us to forecast revenue and other operating results.
  • Purchase of our instruments by our customers requires a significant capital investment which can impact sales in times of constrained spending.
  • Because a significant portion of our revenue comes from a few large customers, any significant decrease in sales to these customers, due to industry consolidation or otherwise, could harm our operating results.
  • Our long-term results depend upon our ability to improve existing products and introduce and market new products successfully and timely.
  • We may experience delays in launching and commercializing our next-generation instruments, on our anticipated timeline, which could adversely affect our business, financial condition, and results of operations.
  • Defects or other quality issues in our products could lead to unforeseen costs, product recalls, adverse regulatory actions, negative publicity, and litigation, including product liability claims, any of which could cause customers to decide not to purchase our products, harm our reputation, and negatively affect our sales, operating results and financial condition.
  • Our reliance on distributors for sales of our products outside of the United States could impact our revenue.
  • We generate a substantial portion of our revenue internationally and we expect this will continue in the future; as a result, our business is subject to various risks relating to our international activities, which could adversely affect our business, operating results and financial condition.
  • We rely on single contract manufacturers for several of our key instruments, and we expect to that to continue in the future. If any of these manufacturers should fail to perform, or not perform satisfactorily, our ability to supply these instruments would be negatively and adversely affected, which could have a material adverse effect on our business, financial condition, results of operations and reputation.
  • We rely on a limited number of suppliers or, in some cases, one supplier, for some of our materials and components used in our consumable products and services and certain of our instruments, and we may not be able to find replacements or immediately transition to alternative suppliers if any of these suppliers fail to perform, which could have a material adverse effect on our business, financial condition, results of operations and reputation.
  • We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and other worldwide anti-bribery laws by us or our agents.
  • The life sciences research and diagnostic markets are highly competitive. If we fail to effectively compete, our business, financial condition and operating results will suffer.
  • Integrating any business, product or technology we acquire can be expensive and time-consuming and can disrupt and adversely affect our ongoing business, including product sales, and distract our management.
  • Risks Related to Government Regulation and Diagnostic Product Reimbursement
  • Changes in U.S. government policies, including reductions in federal research funding and the impacts of tariffs, are adversely affecting our business, though the full extent of the impact is uncertain. Similarly, there is substantial uncertainty regarding how the current administration’s initiatives might impact the FDA, its implementations of laws, regulations, policies and guidance and its personnel, which could prevent, limit or delay development and regulatory approval of our future diagnostic products.
  • If the FDA determines that our products are subject to regulation as medical devices, if Congress enacts new laws that subject our LDT to FDA regulation, if we seek to market our products for clinical diagnostic or health screening use, or if we continue to expand our product, technology and service offerings and the applications and uses of our products into new fields, we expect to become subject to additional government regulations, and the regulatory approval and maintenance process would be expensive, time-consuming and uncertain both in timing and in outcome.
  • Our products may in the future be subject to product recalls that could harm our reputation, business and financial results.
  • U.S. legislative, FDA or global regulatory reforms may make it more difficult and costly for us to obtain any required regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained.
  • If we do not comply with governmental regulations applicable to our CLIA-certified laboratory, we may not be able to continue our laboratory operations or continue offering our LDTs.
  • We expect to rely on third parties in conducting any required future studies of diagnostic products that may be required by the FDA or other regulatory authorities, and those third parties may not perform satisfactorily.
  • If diagnostic procedures that are enabled by our technology are subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, our business could be harmed.
  • Risks Related to our Operations
  • We depend on our information technology systems, and any failure of these systems could harm our business.
  • Cybersecurity breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
  • We are currently subject to, and may in the future become subject to additional, U.S. federal and state and international laws and regulations imposing obligations on how we collect, store and process personal information. Our actual or perceived failure to comply with such obligations could harm our business. Ensuring compliance with such laws could also impair our efforts to maintain and expand our future customer base, and thereby decrease our revenue.
  • Risks Related to Intellectual Property
  • Inability to adapt to and effectively incorporate potential advantages of artificial intelligence (“AI”) could negatively impact our ability to compete, and inability to manage the risks of AI could expose us to liability or put us at a disadvantage.
  • If we are unable to protect our intellectual property, our ability to maintain any technological or competitive advantage over our competitors and potential competitors may be reduced, and our business may be harmed.
  • Some of our owned and in-licensed intellectual property has been discovered through government-funded programs and thus is subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. industry. Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements, and limit our ability to contract with non-U.S. manufacturers.
  • Our rights to develop and commercialize our products and technologies are subject, in part, to the terms and conditions of licenses granted to us by others.
  • If we or any of our partners are sued for infringing intellectual property rights of third parties, the resulting litigation would be costly and time-consuming, and an unfavorable outcome in that litigation could have a material adverse effect on our business.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time- consuming and unsuccessful.
  • We may not be able to protect our intellectual property rights throughout the world, which could have a material adverse effect on our business.
  • We use third-party software that may be difficult to replace or may cause errors or failures of our products that could lead to lost customers or harm to our reputation. Additionally, our use of “open source” software could adversely affect our ability to offer our products and technologies and subject us to possible litigation.
  • Risks Related to our Common Stock and Being a Public Company
  • The market price of our common stock has fluctuated significantly and may continue to fluctuate significantly.
  • We have never paid dividends on our capital stock, and we do not anticipate paying any dividends in the foreseeable future. Consequently, any gains from an investment in our common stock will likely depend on whether the price of our common stock increases.
  • Anti-takeover provisions contained in our restated certificate of incorporation and restated by-laws, as well as provisions of Delaware law, could impair a takeover attempt.

Legal proceedings

In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation consisting of intellectual property, contractual, employment, and other matters. While the outcome of any such actions or proceedings cannot be predicted with certainty, as of the date of this Annual Report on Form 10-K, we were not party to any legal proceedings, the outcome of which would be expected to have a material adverse effect on our financial condition or results of operations. Regardless of any outcome, litigation can have a material adverse effect on us due to defense and settlement costs, diversion of management resources, and other factors.

The opening of Item 3, Legal Proceedings.6

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