Quanterix (QTRX) risk factors, FY2024 10-K

Risks Relating to the Merger

1. 01The Merger may not be completed and the Merger Agreement may be terminated in accordance with its terms
2. 02Failure to complete the Merger could negatively impact our future business and financial results and the trading price of our common stock
3. 03Actions of activist or dissident stockholders could delay or prevent the approval of the Merger and negatively affect our business and operations
4. 04The 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
5. 05After 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
6. 06Until 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
7. 07Obtaining 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
8. 08Failure to attract, motivate and retain executives and other key employees could diminish the anticipated benefits of the Merger
9. 09Whether 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
10. 10The Merger Agreement contains provisions that could discourage a potential competing acquirer that might be willing to pay more to acquire or merge with us
11. 11Akoya, 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
12. 12We expect to incur substantial costs related to the Merger and integration

Risks Relating to the Combined Company

1. 13Certain 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
2. 14Completion 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

Risks Related to our Financial Condition and Financial Reporting Matters

1. 15Failure 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
2. 16The 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
3. 17Our quarterly and annual operating results and cash flows have fluctuated in the past and might continue to fluctuate, which could cause the value of our common stock to fluctuate or decline significantly
4. 18We 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
5. 19Our ability to use net operating losses to offset future income may be subject to certain limitations

Risks Related to our Business

1. 20If our products fail to achieve and sustain sufficient market acceptance, our revenue will be adversely affected
2. 21Sales 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
3. 22We may not be successful in penetrating the diagnostics market
4. 23The sales cycle for our Simoa instruments can be lengthy and variable, which makes it difficult for us to forecast revenue and other operating results
5. 24Purchase of our Simoa instruments requires a significant capital investment which can impact sales in times of constrained spending
6. 25Because 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
7. 26Our long-term results depend upon our ability to improve existing products and introduce and market new products successfully and timely
8. 27We 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
9. 28include, but are not limited to, unforeseen technical challenges, supply chain disruptions, and delays in manufacturing. Many of these risks are beyond our control
10. 29Our reliance on distributors for sales of our products outside of the United States could impact our revenue
11. 30We 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
12. 31If we are unable to manage these risks effectively, our business, operating results and financial condition will suffer
13. 32timely manner or on commercially reasonable terms. If either of these manufacturers are not able to supply instruments, our business would be harmed
14. 33We 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
15. 34The life sciences research and diagnostic markets are highly competitive. If we fail to effectively compete, our business, financial condition and operating results will suffer
16. 35Integrating 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
17. 36If 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

Risks Related to Government Regulation and Diagnostic Product Reimbursement

1. 37Changes in U.S. government policies, including increased tariffs and potential reductions in federal research funding, could adversely affect our business
2. 38If 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
3. 39Our products may in the future be subject to product recalls that could harm our reputation, business and financial results
4. 40U.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
5. 41If we do not comply with governmental regulations applicable to our CLIA-certified laboratory, we may not be able to continue our Accelerator laboratory operations or continue offering our LDTs
6. 42We 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
7. 43If 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

1. 44We depend on our information technology systems, and any failure of these systems could harm our business
2. 45Cybersecurity 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

1. 46If 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
2. 47Our 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
3. 48If 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
4. 49We 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
5. 50We may not be able to protect our intellectual property rights throughout the world, which could have a material adverse effect on our business
6. 51We 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

Risks Related to our Common Stock and Being a Public Company

1. 52The market price of our common stock has fluctuated significantly and may continue to fluctuate significantly
2. 53We 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
3. 54Anti-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
4. 55These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management