Quanterix (QTRX) FY2025 10-K Risk Factors: 10 New, 25 Dropped

What the changes say

Quanterix faces integration and cost-saving risks following its Akoya acquisition.

What changed since the prior 10-K

New

NewRisks Related to our Financial Condition and Financial Reporting Matters
In our Annual Reports on Form 10-K for the years ended December 31, 2022, 2023 and 2024, we disclosed certain material weaknesses in our internal control over financial reporting relating to the operating effectiveness of our internal controls. We have remediated these previously disclosed material weaknesses
We remediated previous material weaknesses in our internal control over financial reporting, but future control failures could harm our stock price and capital market access.
NewRisks 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
Combining our business with Akoya may be difficult, costly, or time-consuming, and we may fail to realize anticipated synergies.
NewRisks Related to our Business
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
We aim to reduce annualized operating expenses by $85.0 million in 2026 after realizing $74.0 million in synergies and incurring $8.0 million in 2025 severance costs.
NewRisks Related to 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
Board and management transitions in late 2025 and early 2026, including CEO Everett Cunningham, could shift our strategic plan and product focus.
NewRisks Related to our Business
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
Sales of our Simoa-based neurology assays have become increasingly critical, and any adoption of competitive technologies by customers would harm our revenues.
NewRisks Related to Government Regulation and Diagnostic Product Reimbursement
to absorb the costs in some cases and/or increase the prices of certain of our products. This could adversely impact demand for our products and our competitive positioning
Federal administration personnel changes could impair the FDA's ability to retain staff, delaying regulatory guidance and approvals for our diagnostic products.
NewRisks 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
Failing to effectively incorporate artificial intelligence or manage its associated legal and compliance risks could put us at a competitive disadvantage.
NewRisks Related to Intellectual Property
property does not provide adequate coverage over our products and protection against our competitors’ products, our competitive position could be adversely affected, as could our business
Our trademarks, trade secrets, and confidentiality agreements may fail to protect our intellectual property from unauthorized disclosure or misappropriation.
NewRisks Related to Intellectual Property
PhenoCycler product, and with the University of Washington and Revvity pursuant to which we have in-licensed important patents that protect key aspects of our current and future PhenoImager technologies
We rely on third-party licensors like Revvity to prosecute and maintain patents for our PhenoImager technology, and they may not act in our best interests.
NewRisks Related to Intellectual Property
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
Terminating our license agreements with Tufts, Stanford, University of Washington, Revvity, Cambridge Research, or VisEn Medical would harm our business.

Dropped

DroppedRisks Relating to the Merger
The Merger may not be completed and the Merger Agreement may be terminated in accordance with its terms
The Merger may not be completed and the Merger Agreement may be terminated.
DroppedRisks Relating to the Merger
Failure to complete the Merger could negatively impact our future business and financial results and the trading price of our common stock
Failure to complete the Merger could negatively impact our future business and stock price.
DroppedRisks Relating to the Merger
Actions of activist or dissident stockholders could delay or prevent the approval of the Merger and negatively affect our business and operations
Actions of activist stockholders could delay or prevent Merger approval.
DroppedRisks Relating to the Merger
The issuance of shares of our common stock to Akoya stockholders in connection with the Merger may cause the market price of our common stock to decline
Issuing shares to Akoya stockholders may cause our common stock price to decline.
DroppedRisks Relating to the Merger
After the Merger, our stockholders will have a reduced ownership and voting interest in the Combined Company and may not realize a benefit from the Merger commensurate with their ownership dilution
Our stockholders will have a reduced ownership and voting interest in the combined company.
DroppedRisks Relating to the Merger
Until the completion of the Merger or the termination of the Merger Agreement pursuant to our terms, we are prohibited from entering into certain transactions and taking certain actions that might otherwise be beneficial to us and our stockholders
The Merger Agreement restricts us from taking certain beneficial transactions prior to completion.
DroppedRisks Relating to the Merger
Obtaining required approvals and satisfying closing conditions may prevent or delay completion of the Merger, and regulatory approvals may not be received, may take longer than expected or may impose conditions that are not presently anticipated or cannot be met
Obtaining required approvals and satisfying closing conditions may delay or prevent the Merger.
DroppedRisks Relating to the Merger
Failure to attract, motivate and retain executives and other key employees could diminish the anticipated benefits of the Merger
Failure to retain key employees could diminish anticipated Merger benefits.
DroppedRisks Relating to the Merger
Whether or not the Merger is completed, the announcement and pendency of the Merger could cause disruptions in our business, which could have an adverse effect on our business and financial results
Announcement and pendency of the Merger could cause business disruptions and divert management attention.
DroppedRisks Relating to the Merger
The Merger Agreement contains provisions that could discourage a potential competing acquirer that might be willing to pay more to acquire or merge with us
The Merger Agreement contains provisions discouraging competing acquirers.
DroppedRisks Relating to the Merger
Akoya, respectively, will have an opportunity to offer to modify the terms of the Merger Agreement before our board or the Akoya board, respectively, may withdraw or qualify our recommendation to stockholders, with respect to the approval of the Merger, in favor of such superior proposal
We may be required to pay a $9 million termination fee to Akoya.
DroppedRisks Relating to the Merger
We expect to incur substantial costs related to the Merger and integration
We expect to incur substantial non-recurring costs related to the Merger.
DroppedRisks Relating to the Combined Company
Certain customers may seek to modify contractual relationships with the Combined Company, which could have an adverse effect on the Combined Company’s business and operations
DroppedRisks Relating to the Combined Company
Completion of the Merger may trigger change in control, assignment or other provisions in certain agreements to which Akoya is a party, which may have an adverse impact on the Combined Company’s business and results of operations
DroppedRisks Related to our Financial Condition and Financial Reporting Matters
Failure to remediate material weaknesses in, or inherent limitations associated with, our internal control over financial reporting have resulted in, and in the future could result in, material misstatements in our financial statements
DroppedRisks Related to our Financial Condition and Financial Reporting Matters
The Restatement of our financial statements may affect stockholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations
DroppedRisks Related to our Business
Sales of our assays for neurological indications have become increasingly important to our business, and any significant decrease in sales of such assays could have a material adverse effect on our business
DroppedRisks Related to our Business
include, but are not limited to, unforeseen technical challenges, supply chain disruptions, and delays in manufacturing. Many of these risks are beyond our control
DroppedRisks Related to our Business
timely manner or on commercially reasonable terms. If either of these manufacturers are not able to supply instruments, our business would be harmed
DroppedRisks Related to our Business
If we are unable to perform the above functions or otherwise effectively integrate any acquired businesses, products or technologies, our business, financial condition and operating results will suffer
DroppedRisks Related to Government Regulation and Diagnostic Product Reimbursement
Changes in U.S. government policies, including increased tariffs and potential reductions in federal research funding, could adversely affect our business
DroppedRisks Related to Government Regulation and Diagnostic Product Reimbursement
If these or similar policy changes continue or expand, we may face increased costs and demand for our products could be impacted. We cannot predict the full extent of these impacts, but any prolonged disruption could adversely affect our business, financial condition, and results of operations
DroppedRisks Related to Intellectual Property
Our Simoa bead-based technology is licensed to us by Tufts. Any loss of our rights to this technology or other technologies we license could prevent us from selling our products
DroppedRisks Related to Intellectual Property
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
DroppedRisks Related to our Common Stock and Being a Public Company
These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management

Reworded

98% rewrittenRisks Related to our Business
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
Removed specific reference to launching the Simoa ONE instrument by the end of 2025.
Was: We may experience delays in launching our next-generation instrument, Simoa ONE, on our anticipated timeline, which could adversely affect our business, financial condition, and results of operations
89% rewrittenRisks Related to our Business
If we are unable to manage these risks effectively, our business, operating results and financial condition will suffer
Updated single contract manufacturer disclosures, removing the specific timeline for the Simoa ONE instrument.
77% rewrittenRisks Related to our Financial Condition and Financial Reporting Matters
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
Added Akoya's net losses of $55.4 million for 2024 and $63.3 million for 2023, and updated Quanterix 2025 net loss to $107.2 million.
Was: We have incurred annual losses since we were formed and expect to incur losses in the future. We cannot be certain that we will achieve or sustain profitability
72% rewrittenRisks Related to Intellectual Property
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
Retained core intellectual property protection risks with minor stylistic wording updates.
66% rewrittenRisks Related to our Business
Purchase of our instruments by our customers requires a significant capital investment which can impact sales in times of constrained spending
Added that 2025 macro-economic headwinds included reduced US federal research funding, lower pharma R&D spending, and new import tariffs.
Was: Purchase of our Simoa instruments requires a significant capital investment which can impact sales in times of constrained spending
56% rewrittenRisks Related to our Common Stock and Being a Public Company
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
Minor punctuation and phrasing clean-up regarding Delaware anti-takeover provisions.
47% rewrittenRisks Related to Intellectual Property
We may not be able to protect our intellectual property rights throughout the world, which could have a material adverse effect on our business
Retained international patent protection risks with virtually identical prior year wording.
45% rewrittenRisks Related to Government Regulation and Diagnostic Product Reimbursement
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
Added that CMS often uses Medicare Administrative Contractors and other third parties to make coverage decisions for diagnostic products.
44% rewrittenRisks Related to our Business
If our products fail to achieve and sustain sufficient market acceptance, our revenue will be adversely affected
41% rewrittenRisks Related to Government Regulation and Diagnostic Product Reimbursement
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
37% rewrittenRisks Related to our Business
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
30% rewrittenRisks Related to Government Regulation and Diagnostic Product Reimbursement
Our products may in the future be subject to product recalls that could harm our reputation, business and financial results
25% rewrittenRisks Related to our Business
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
25% rewrittenRisks Related to our Business
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

All 40 risk factors

Headings as the filing states them, in filing order.

Risks Related to our Financial Condition and Financial Reporting Matters

01Our 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
02We 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 profitability77% rewritten
03In our Annual Reports on Form 10-K for the years ended December 31, 2022, 2023 and 2024, we disclosed certain material weaknesses in our internal control over financial reporting relating to the operating effectiveness of our internal controls. We have remediated these previously disclosed material weaknessesNew
04Our ability to use net operating losses to offset future income may be subject to certain limitations

Risks Related to our Business

05Combining 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 stockNew
06We 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 businessNew
07Recent 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 changesNew
08If our products fail to achieve and sustain sufficient market acceptance, our revenue will be adversely affected44% rewritten
09Sales 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 productsNew
10We may not be successful in penetrating the diagnostics market
11The sales cycle for our instruments can be lengthy and variable, which makes it difficult for us to forecast revenue and other operating results
12Purchase of our instruments by our customers requires a significant capital investment which can impact sales in times of constrained spending66% rewritten
13Because 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 results25% rewritten
14Our long-term results depend upon our ability to improve existing products and introduce and market new products successfully and timely
15We 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 operations98% rewritten
16Our reliance on distributors for sales of our products outside of the United States could impact our revenue
17We 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 condition25% rewritten
18If we are unable to manage these risks effectively, our business, operating results and financial condition will suffer89% rewritten
19We 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
20The life sciences research and diagnostic markets are highly competitive. If we fail to effectively compete, our business, financial condition and operating results will suffer
21Integrating 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 management37% rewritten

Risks Related to Government Regulation and Diagnostic Product Reimbursement

22to absorb the costs in some cases and/or increase the prices of certain of our products. This could adversely impact demand for our products and our competitive positioningNew
23Our products may in the future be subject to product recalls that could harm our reputation, business and financial results30% rewritten
24U.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 obtained41% rewritten
25If 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
26We 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
27If 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 harmed45% rewritten

Risks Related to our Operations

28We depend on our information technology systems, and any failure of these systems could harm our business
29Cybersecurity 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

Risks Related to Intellectual Property

30Inability 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 disadvantageNew
31If 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 harmed72% rewritten
32property does not provide adequate coverage over our products and protection against our competitors’ products, our competitive position could be adversely affected, as could our businessNew
33PhenoCycler product, and with the University of Washington and Revvity pursuant to which we have in-licensed important patents that protect key aspects of our current and future PhenoImager technologiesNew
34Our rights to develop and commercialize our products and technologies are subject, in part, to the terms and conditions of licenses granted to us by othersNew
35If 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
36We 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
37We may not be able to protect our intellectual property rights throughout the world, which could have a material adverse effect on our business47% rewritten

Risks Related to our Common Stock and Being a Public Company

38The market price of our common stock has fluctuated significantly and may continue to fluctuate significantly
39We 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
40Anti-takeover provisions contained in our restated certificate of incorporation and restated by-laws, as well as provisions of Delaware law, could impair a takeover attempt56% rewritten

Other Quanterix 10-Ks

FY2024 10-K risk factors
55 risks
Quanterix faces concentration risks around its upcoming Akoya merger, single-source instrument manufacturers, and a reliance on key customers and neurological assays.
Filed Mar 17, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.