Biggest changeWe can give no assurance that the measures we have taken and plan to take in the future will remediate the material weaknesses identified or that any additional material weaknesses or restatements of our financial statements will not arise in the future due to a failure to implement and maintain adequate internal control over financial reporting or disclosure controls and procedures. 28 Table of Contents Further, in the future, if we cannot conclude that we have effective internal control over financial reporting or disclosure controls and procedures, or if our independent registered public accounting firm is unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in the reliability of our financial statements, which could lead to a decline in our stock price.
Biggest changeFurther, in the future, if we cannot conclude that we have effective internal control over financial reporting or disclosure controls and procedures, or if our independent registered public accounting firm is unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in the reliability of our financial statements, which could lead to a decline in our stock price.
Even if we are granted a patent, in certain circumstances we may be unable protect our rights to, or use of, our technology. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use.
Even if we are granted a patent, in certain circumstances we may be unable to protect our rights to, or use of, our technology. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use.
As a part of our growth strategy, we have made, and may continue to make, selected acquisitions of other companies and technologies and continue to evaluate expansion through acquisitions of other companies or technologies, which may carry numerous risks and operational, financial, and managerial challenges, including, but not limited to, the following, any of which could adversely affect our business, financial condition, or results of operations: • difficulties in integrating new operations, technologies, products, and personnel; • problems maintaining uniform procedures, controls, and policies with respect to our financial accounting systems; • lack of synergies or the inability to realize expected synergies and cost-savings; • difficulties in managing geographically dispersed operations, including risks associated with entering foreign markets in which we have no or limited prior experience; • underperformance of any acquired technology, product, or business relative to our expectations and the price we paid; • negative near-term impacts on financial results after an acquisition, including acquisition-related earnings charges; • the potential loss of key strategic partners of acquired companies; • claims by terminated employees and shareholders of acquired companies or other third parties related to the transaction; • the assumption or incurrence of additional debt obligations or expenses, or use of substantial portions of our cash; • diversion of management’s attention and company resources from existing operations of the business; • inconsistencies in standards, controls, procedures, and policies; • cash expenses and non-cash accounting charges incurred in connection with acquisitions, including unanticipated costs associated with the amortization of intangible assets; • the impairment of intangible assets as a result of technological advancements, or worse-than-expected performance of acquired companies; • assumption of, or exposure to, historical liabilities of the acquired business, including unknown contingent or similar liabilities, including product liability, that are difficult to identify or accurately quantify; and • risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property.
As a part of our growth strategy, we have made, and may continue to make, selected acquisitions of other companies and technologies and continue to evaluate expansion through acquisitions of other companies or technologies, which may carry numerous risks and operational, financial, and managerial challenges, including, but not limited to, the following, any of which could adversely affect our business, financial condition, or results of operations: • difficulties in integrating new operations, technologies, products, and personnel; • problems maintaining uniform procedures, controls, and policies with respect to our financial accounting systems; • lack of synergies or the inability to realize expected synergies and cost-savings; • difficulties in managing geographically dispersed operations, including risks associated with entering foreign markets in which we have no or limited prior experience; • underperformance of any acquired technology, product, or business relative to our expectations and the price we paid; • negative near-term impacts on financial results after an acquisition, including acquisition-related earnings charges; • the potential loss of key strategic partners of acquired companies; • claims by terminated employees and shareholders of acquired companies or other third parties related to the transaction; • the assumption or incurrence of additional debt obligations or expenses, or use of substantial portions of our cash; • diversion of management’s attention and company resources from existing operations of the business; • inconsistencies in standards, controls, procedures, and policies; • cash expenses and non-cash accounting charges incurred in connection with acquisitions, including unanticipated costs associated with the amortization of intangible assets; • the impairment of intangible assets as a result of technological advancements, or worse-than-expected performance of acquired companies; 21 Table of Contents • assumption of, or exposure to, historical liabilities of the acquired business, including unknown contingent or similar liabilities, including product liability, that are difficult to identify or accurately quantify; and • risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property.
Any of these catastrophic events, whether in the United States or abroad, may have a strong negative impact on the global economy, our employees, facilities, partners, suppliers, distributors or customers, and could decrease demand for our products, create delays and inefficiencies in our supply chain and make it difficult or impossible for us to deliver products to our customers.
Any of these events, whether in the United States or abroad, may have a strong negative impact on the global economy, our employees, facilities, partners, suppliers, distributors or customers, and could decrease demand for our products, create delays and inefficiencies in our supply chain and make it difficult or impossible for us to deliver products to our customers.
The EU’s General Data Protection Regulation, or GDPR, which became effective in May 2018, applies to our activities related to products and services that we offer to EU customers and workers. The GDPR established new requirements regarding the handling of personal data and includes significant penalties for non-compliance.
The EU’s General Data Protection Regulation ("GDPR"), which became effective in May 2018, applies to our activities related to products and services that we offer to EU customers and workers. The GDPR established new requirements regarding the handling of personal data and includes significant penalties for non-compliance.
The trading price and volume of our common stock, traded on the NASDAQ Capital Market, or NASDAQ, has been highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control.
The trading price and volume of our common stock, traded on the Nasdaq Capital Market ("Nasdaq") has been highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control.
The future market price and trading volume of our common stock could be significantly impacted by numerous factors, including, but not limited to: • Future sales of our common stock or other capital raising events by us; • Sales of our common stock by existing shareholders; • Changes in our capital structure, including stock splits or reverse stock splits; • Changes in our product offerings and business structure through acquisitions or divestitures, and public perception of our announced acquisitions and divestitures; • Announcements of technological innovations for new commercial products by our present or potential competitors; • Developments concerning proprietary rights; • Adverse results in our field or with clinical tests of our products in customer applications; • Adverse litigation; • Unfavorable legislation or regulatory decisions; • Public concerns regarding our products; • Variations in quarterly operating results; • General trends in the health care and biotechnology industries; • Global viruses, epidemics, and pandemics; and • Other factors outside of our control, including significant market fluctuations.
The future market price and trading volume of our common stock could be significantly impacted by numerous factors, including, but not limited to: • Future sales of our common stock or other capital raising events by us; • Sales of our common stock by existing shareholders; • Changes in our capital structure, including stock splits or reverse stock splits; • Changes in our product offerings and business structure through acquisitions or divestitures, and public perception of our announced acquisitions and divestitures; • Announcements of technological innovations for new commercial products by our present or potential competitors; • Developments concerning proprietary rights; • Adverse results in our field or with clinical tests of our products in customer applications; • Adverse litigation; • Unfavorable legislation or regulatory decisions; 27 Table of Contents • Public concerns regarding our products; • Variations in quarterly operating results; • General trends in the health care and biotechnology industries; • Global viruses, epidemics, and pandemics; and • Other factors outside of our control, including significant market fluctuations.
If a third party asserts that we infringed its patents or other proprietary rights, we could face a number of risks that could seriously harm our results of operations, financial condition and competitive position, including: • patent infringement and other intellectual property claims, which would be costly and time consuming to defend, whether or not the claims have merit, and which could delay a product and divert management’s attention from our business; • substantial damages for past infringement, which we may have to pay if a court determines that our product or technologies infringe a competitor’s patent or other proprietary rights; • a court prohibiting us from selling or licensing our technologies unless the third party licenses its patents or other proprietary rights to us on commercially reasonable terms, which it is not required to do; and • if a license is available from a third party, we may have to pay substantial royalties or lump-sum payments or grant cross licenses to our patents or other proprietary rights to obtain that license.
If a third party asserts that we infringed its patents or other proprietary rights, we could face a number of risks that could seriously harm our results of operations, financial condition and competitive position, including: • patent infringement and other intellectual property claims, which would be costly and time consuming to defend, whether or not the claims have merit, and which could delay a product and divert management’s attention from our business; • substantial damages for past infringement, which we may have to pay if a court determines that our product or technologies infringe a competitor’s patent or other proprietary rights; 24 Table of Contents • a court prohibiting us from selling or licensing our technologies unless the third party licenses its patents or other proprietary rights to us on commercially reasonable terms, which it is not required to do; and • if a license is available from a third party, we may have to pay substantial royalties or lump-sum payments or grant cross licenses to our patents or other proprietary rights to obtain that license.
Manufacturing our products may be impacted by: • availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier; • the ongoing capacity of our facilities and those of our outside manufacturers; • our and our outside manufacturers’ ability to comply with existing and new regulatory requirements, including cGMP; • inclement weather and natural disasters; • changes in forecasts of future demand for product components; 18 Table of Contents • potential facility contamination by microorganisms or viruses; • updating of manufacturing specifications; • product quality success rates and yields; • labor strikes; and • global viruses, pandemics and epidemics.
Manufacturing our products may be impacted by: • availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier; • the ongoing capacity of our facilities and those of our outside manufacturers; • our and our outside manufacturers’ ability to comply with existing and new regulatory requirements, including cGMP; • inclement weather and natural disasters; • changes in forecasts of future demand for product components; • potential facility contamination by microorganisms or viruses; • updating of manufacturing specifications; • product quality success rates and yields; • labor strikes; and • global viruses, pandemics and epidemics.
Any failure of us or our associated third parties to maintain the security of our network systems and the proprietary, confidential, and personal data in our possession, including via the penetration of our network security and the misappropriation of proprietary, confidential and personal information, could result in costly investigations and remediation, business disruption, damage to our reputation, financial obligations to third parties, fines, penalties, regulatory proceedings and private litigation with potentially large costs, and also result in deterioration in our employees’, customers’, suppliers’ and business partners’ confidence in us and other competitive disadvantages, and thus could have a material adverse effect on our business, financial condition and results of operations.
Any failure of us or our associated third parties to maintain the security of our network systems and the proprietary, confidential, and personal data in our possession, including via the penetration of our network security and the misappropriation of proprietary, confidential and personal information, could result in costly investigations and remediation, business disruption, damage to our reputation, financial obligations to third parties, fines, penalties, regulatory proceedings and private litigation with potentially large costs, and also result in deterioration in our employees’, customers’, suppliers’ and business partners’ confidence in us and 26 Table of Contents other competitive disadvantages, and thus could have a material adverse effect on our business, financial condition and results of operations.
Our ability to negotiate favorable terms with those suppliers may be limited, and if those suppliers experience operational, financial, quality, or regulatory difficulties, or if those suppliers and/or their facilities refuse to supply us or cease operations temporarily or permanently, or if those suppliers take unreasonable business positions, we could be forced to cease product manufacturing until the suppliers resume operations, until alternative suppliers could be identified and qualified, or permanently if the suppliers do not resume operations and no alternative suppliers could be identified and qualified.
As a result, our ability to negotiate favorable terms with those suppliers may be limited, and if those suppliers experience operational, financial, quality, or regulatory difficulties, or if those suppliers and/or their facilities refuse to supply us or cease operations temporarily or permanently, or if those suppliers take unreasonable business positions, we could be forced to cease product manufacturing until the suppliers resume operations, until alternative suppliers could be identified and qualified, or permanently if the suppliers do not resume operations and no alternative suppliers could be identified and qualified.
The extent to which public health crises, including health pandemics and epidemics and other outbreaks, impact our business operations, financial performance and results of operations remains uncertain and will depend on many factors outside our control, including the timing, extent, trajectory and duration of the public health crisis, the emergence of new variants, the development, availability, distribution and effectiveness of vaccines and treatments, and the imposition of 29 Table of Contents protective public safety measures.
The extent to which public health crises, including health pandemics and epidemics and other outbreaks, impact our business operations, financial performance and results of operations remains uncertain and will depend on many factors outside our control, including the timing, extent, trajectory and duration of the public health crisis, the emergence of new variants, the development, availability, distribution and effectiveness of vaccines and treatments, and the imposition of protective public safety measures.
We expect our operating results to fluctuate significantly from period to period. Our revenue, operating margins and other operating results have varied significantly in the past and may continue to fluctuate from period to period in the future due to a variety of factors, many of which are beyond our control.
Our revenue, operating margins and other operating results have varied significantly in the past and may continue to fluctuate from period to period in the future due to a variety of factors, many of which are beyond our control.
Customers use our products to maintain the health and function of biologic material during sourcing, manufacturing, storage, and distribution of cells and tissues, and component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks with respect to these or other products we manufacture or sell could result in an unsafe condition or injury.
Customers use our products to maintain the health and 17 Table of Contents function of biologic material during sourcing, manufacturing, storage, and distribution of cells and tissues, and component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks with respect to these or other products we manufacture or sell could result in an unsafe condition or injury.
Specifically, in both the United States and some foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably, including by limiting the prices we are able to charge for our products, the amounts of reimbursement available for our products or the acceptance and availability of our products.
Specifically, in both the United States and some foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably, including by limiting the prices we are able to charge for our products or the acceptance and availability of our products.
We are unable to guarantee the success of any acquisitions that we complete and such acquisitions may not be, or remain, 21 Table of Contents profitable. Our failure to successfully address the foregoing integration risks may prevent us from achieving the anticipated benefits from any acquisition in a reasonable time frame, or at all.
We are unable to guarantee the success of any acquisitions that we complete and such acquisitions may not be, or remain, profitable. Our failure to successfully address the foregoing integration risks may prevent us from achieving the anticipated benefits from any acquisition in a reasonable time frame, or at all.
The patents for our products have varying expiration dates and, when these patents expire, we may be subject to increased competition and we may not be able to recover our development costs. In some of the larger economic territories, such as 22 Table of Contents the United States and Europe, patent term extension/restoration may be available.
The patents for our products have varying expiration dates and, when these patents expire, we may be subject to increased competition and we may not be able to recover our development costs. In some of the larger economic territories, such as the United States and Europe, patent term extension/restoration may be available.
There is substantial competition to 17 Table of Contents attract such key management personnel and the loss of one or more of these individuals could have a material adverse effect on our business and operating results. In addition, a critical factor to our business is our ability to attract and retain essential engineering, scientific, sales and management personnel.
There is substantial competition to attract such key management personnel and the loss of one or more of these individuals could have a material adverse effect on our business and operating results. In addition, a critical factor to our business is our ability to attract and retain essential engineering, scientific, sales and management personnel.
This exclusive forum provision may limit the ability of a stockholder to commence litigation in a forum that the stockholder prefers, or may require a stockholder to incur additional costs in order to commence litigation in Delaware or 27 Table of Contents U.S. federal district court, each of which may discourage such lawsuits against us or our directors or officers.
This exclusive forum provision may limit the ability of a stockholder to commence litigation in a forum that the stockholder prefers, or may require a stockholder to incur additional costs in order to commence litigation in Delaware or U.S. federal district court, each of which may discourage such lawsuits against us or our directors or officers.
If our competitors independently develop equivalent knowledge, methods, and know-how, we would not be able to assert our trade secrets against them and our business could be harmed. Expiration of our patents may subject us to increased competition and reduce our opportunity to generate product revenue.
If our competitors independently develop equivalent knowledge, methods, and know-how, we would not be able to assert our trade secrets against them and our business could be harmed. 23 Table of Contents Expiration of our patents may subject us to increased competition and reduce our opportunity to generate product revenue.
Each of these privacy, security and data protection laws and regulations could impose significant limitations and increase our cost of providing our products and services where we process end user personal data and could harm our results of operations and expose us to significant fines, penalties and other damages.
Each of these privacy, security and data 19 Table of Contents protection laws and regulations could impose significant limitations and increase our cost of providing our products and services where we process end user personal data and could harm our results of operations and expose us to significant fines, penalties, and other damages.
As a result, we proactively employ multiple methods at different layers of our systems to defend our systems against intrusion and attack and to protect the data we collect.
As a result of such breaches, we proactively employ multiple methods at different layers of our systems to defend our systems against intrusion and attack and to protect the data we collect.
We cannot predict the extent to which we might be required to seek licenses or alter our products or services so that they no longer infringe the rights of others. We also cannot guarantee that licenses will be available or the terms of any licenses we 23 Table of Contents may be required to obtain will be reasonable.
We cannot predict the extent to which we might be required to seek licenses or alter our products or services so that they no longer infringe the rights of others. We also cannot guarantee that licenses will be available or the terms of any licenses we may be required to obtain will be reasonable.
Accordingly, a material weakness increases the risk that the financial information we report contains material errors. In the course of making our assessment of the effectiveness of internal control over financial reporting as of December 31, 2024, we identified one material weakness.
Accordingly, a material weakness increases the risk that the financial information we report contains material errors. 29 Table of Contents In the course of making our assessment of the effectiveness of internal control over financial reporting as of December 31, 2024, we identified one material weakness.
To support our current and prospective clinical customers, we and our outsources manufacturers comply with, and intend to continue to comply with, cGMP in the manufacture of our products.
To support our current and prospective clinical customers, we and our outsource manufacturers comply with, and intend to continue to comply with, cGMP in the manufacture of our products.
Any future determination to pay dividends will be at the discretion of our board of directors (the "Board"), subject to compliance with covenants in current and future agreements governing our indebtedness, and will depend on our results 26 Table of Contents of operations, financial condition, capital requirements, contractual arrangements and other factors that our Board deems relevant.
Any future determination to pay dividends will be at the discretion of our Board, subject to compliance with covenants in current and future agreements governing our indebtedness, and will depend on our results of operations, financial condition, capital requirements, contractual arrangements and other factors that our Board deems relevant.
Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code, and it is possible that certain transactions or a combination of certain transactions may result in material additional limitations on our ability to use our net operating loss and tax credit carryforwards.
Our ability to use NOL and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code, and it is possible that certain transactions or a combination of certain transactions may result in material additional limitations on our ability to use our NOL and tax credit carryforwards.
Generally, if an ownership change occurs, the yearly taxable income limitation on the use of net operating loss and tax credit carryforwards and certain built-in losses is equal to the product of the applicable long-term, tax-exempt rate and the value of our stock immediately before the ownership change.
Generally, if an ownership change occurs, the yearly taxable income limitation on the use of NOL and tax credit carryforwards and certain built-in losses is equal to the product of the applicable long-term, tax-exempt rate and the value of our stock immediately before the ownership change.
If our quarterly operating results fail to meet expectations of investors or research analysts, the price of our common stock may decline. If intangible assets and goodwill become impaired, we may have to take significant charges against earnings. As of December 31, 2024 the net carrying value of our goodwill and other intangible assets totaled $221.9 million.
If our quarterly operating results fail to meet expectations of investors or research analysts, the price of our common stock may decline. If intangible assets and goodwill become impaired, we may have to take significant charges against earnings. As of December 31, 2025 the net carrying value of our goodwill and other intangible assets totaled $212.8 million.
Section 382 and 383 of the Internal Revenue Code of 1986, as amended, contain rules that limit the ability of a company that undergoes an ownership change, which is generally any change in ownership of more than 50% of its stock over a three-year period, to utilize its net operating loss and tax credit carryforwards and certain built-in losses recognized in years after the ownership change.
Section 382 and 383 of the Internal Revenue Code contain rules that limit the ability of a company that undergoes an ownership change, which is generally any change in ownership of more than 50% of its stock over a three-year period, to utilize its NOL and tax credit carryforwards and certain built-in losses recognized in years after the ownership change.
If we lose any of these large customers or if there are disruptions in the sales of these products, our net product revenue and operating results could decline significantly. During the years ended December 31, 2024, 2023, and 2022, we derived approximately 28%, 25%, and 32% of our revenue from two customers, respectively.
If we lose any of these large customers or if there are disruptions in the sales of these products, our net product revenue and operating results could decline significantly. During the years ended December 31, 2025, 2024, and 2023, we derived approximately 29%, 32%, and 29% of our revenue from three customers, respectively.
There continues to be a lack of consistent climate legislation, which creates economic and regulatory uncertainty regarding future incentives for energy-efficiency and costs of compliance, which may impact the demand for our products and services, our costs associated with providing our products and services, and our results of operations and financial condition.
There continues to be a lack of consistent climate legislation among local, state, federal and international governmental authorities, which creates economic and regulatory uncertainty regarding future incentives for energy-efficiency and costs of compliance, which may impact the demand for our products and services, our costs associated with providing our products and services, and our results of operations and financial condition.
We may not be successful in defending these claims, and even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees.
We may not be successful in 25 Table of Contents defending these claims, and even if we are successful, litigation could result in substantial costs and be a distraction to our management and other employees.
These measures have been breached in the past, and we cannot be certain that they will be successful and sufficient to counter current and emerging technology threats that are designed to breach our systems in order to gain access to confidential information.
However, we cannot be certain that these measures will be successful and sufficient to counter current and emerging technology threats that are designed to breach our systems in order to gain access to confidential information.
In the years ended December 31, 2024, 2023, and 2022, we derived approximately 73%, 73%, and 77% of our revenue from CryoStor products, respectively. Our principal customers may vary from period to period and such customers may not continue to purchase products from us at current levels or at all.
In the years ended December 31, 2025, 2024, and 2023, we derived approximately 82%, 80%, and 82% of our revenue from CryoStor products, respectively. Our principal customers may 16 Table of Contents vary from period to period and such customers may not continue to purchase products from us at current levels or at all.
Securities litigation and stockholder activism, including potential proxy contests, could result in substantial costs and divert management’s and our board of director’s attention and resources from our business.
Securities litigation and stockholder activism, including potential proxy contests, could result in substantial costs and divert the attention of our management and our board of directors (our “Board”) and resources from our business.
Further, the inability of some of our customers to consummate anticipated purchases of our products due to changes in end- 16 Table of Contents user demand, and other unpredictable factors that may affect customer ordering patterns could lead to significant reductions in net product revenue which could harm our business.
Further, the inability of some of our customers to consummate anticipated purchases of our products due to changes in end-user demand, and other unpredictable factors that may affect customer ordering patterns could lead to significant reductions in net product revenue which could harm our business. We expect our operating results to fluctuate significantly from period to period.
Our success will depend on our ability to attract and retain key personnel. Our success in implementing our business strategy depends largely on the skills, experience and performance of key members of our executive management team and others in key management positions.
Our success in implementing our business strategy depends largely on the skills, experience and performance of key members of our executive management team and others in key management positions.
Any inability to provide reliable financial reports or prevent fraud could harm our business. We regularly review and update our system of internal control over financial reporting, disclosure controls and procedures, and corporate governance policies. In addition, we are required under the Sarbanes-Oxley Act of 2002 to report annually on our internal control over financial reporting.
We regularly review and update our system of internal control over financial reporting, disclosure controls and procedures, and corporate governance policies. In addition, we are required under the Sarbanes-Oxley Act of 2002 to report annually on our internal control over financial reporting.
We cannot assure you that, in the future, our current or alternative sources for manufacturing supplies will be able to meet all our demands on a timely basis.
We cannot assure you that, in the future, our current or alternative sources for materials, supplies, and services used in our product manufacturing, as well as some of our products, will be able to meet all our demands on a timely basis.
As of December 31, 2024, based on our review of public filings and our records, one of our existing stockholders, Casdin Capital, LLC owned 8,707,165 shares of our common stock, representing 18.6% of the issued and outstanding shares of common stock.
As of December 31, 2025, based on our review of public filings and our records, one of our existing stockholders, Casdin Capital, LLC owned 5,957,165 shares of our common stock, representing 12.4% of the issued and outstanding shares of common stock.
The material weakness identified was in relation to not maintaining effective internal controls to verify that key inputs for our stock-based awards were entered correctly into the equity system early in 2024, which was attributable to an outdated internal policy with unclear guidance regarding appropriate inputs.
The material weakness identified was in relation to not maintaining effective internal controls to verify that key inputs for our stock-based awards were entered correctly into the equity system early in 2024, which was attributable to an outdated internal policy with unclear guidance regarding appropriate inputs The aforementioned material weaknesses did not result in any identified material misstatements to our financial statements, and there were only immaterial changes to previously released financial results.
A loss of key personnel or their work product could diminish or prevent our ability to commercialize our products, which could have an adverse effect on our business, results of operations and financial condition. 24 Table of Contents Our inability to protect our information systems and networks and the proprietary and confidential information in our possession from continually evolving cybersecurity risks or other technological risks, including as a result of breaches of our associated third parties' information technology systems, could materially adversely impact our business, financial condition and results of operations, in addition to our reputation and relationships with our employees, customers, suppliers and business partners.
Our inability to protect our information systems and networks and the proprietary and confidential information in our possession from continually evolving cybersecurity risks or other technological risks, including as a result of breaches of our associated third parties' information technology systems, could materially adversely impact our business, financial condition and results of operations, in addition to our reputation and relationships with our employees, customers, suppliers and business partners.
Our Amended and Restated Bylaws designate the Court of Chancery of the State of Delaware and U.S. federal district courts as the exclusive forums for certain types of actions and proceedings that may be initiated by our stockholders, which limits our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, or other employees.
These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board, which is responsible for appointing the members of our management. 28 Table of Contents Our Amended and Restated Bylaws designate the Court of Chancery of the State of Delaware and U.S. federal district courts as the exclusive forums for certain types of actions and proceedings that may be initiated by our stockholders, which limits our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, or other employees.
Any reduction or impairment of value of intangible assets and goodwill will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods. We depend on outside suppliers for all our manufacturing supplies, parts and components.
Any reduction or impairment of value of intangible assets and goodwill will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods. Our success will depend on our ability to attract and retain key personnel.
For example, in the year ended December 31, 2024, the highest intra-day sale price of our common stock on NASDAQ was $28.88 per share and the lowest intra-day sale price of our common stock on NASDAQ was $14.50 per share. Our highest trading day volume was 1,692,900 shares traded and the lowest trading day volume was 106,600 shares traded.
For example, in the year ended December 31, 2025, the highest intra-day sale price of our common stock on Nasdaq was $29.62 per share and the lowest intra-day sale price of our common stock on Nasdaq was $19.10 per share. Our highest trading day volume was 1,625,800 shares traded and the lowest trading day volume was 105,900 shares traded.
While we are not currently subject to FDA or other regulatory approvals, if our products become subject to regulatory requirements, the manufacture and sale of our products may be delayed or prevented, or we may become subject to increased expenses.
Risks relating to the lingering effects of global supply chain disruptions may even continue after current conflicts have subsided. While we are not currently subject to FDA or other regulatory approvals, if our products become subject to regulatory requirements, the manufacture and sale of our products may be delayed or prevented, or we may become subject to increased expenses.
A catastrophic event that results in the destruction or disruption of our data centers or our critical business or information technology systems would severely affect our ability to conduct normal business operations and, as a result, our operating results would be adversely affected.
If any of these events result in the destruction or disruption of our data centers or our critical business or information technology systems it could severely affect our ability to conduct normal business operations and, as a result, our operating results would be adversely affected. Tariffs and other trade policies could have a substantial impact on our business.
Unavailability of necessary components could require us to re-engineer our products to accommodate available substitutions, which could increase costs to us and/or have a material adverse effect on manufacturing schedules, products performance and market acceptance. We might not be able to find a sufficient alternative supplier in a reasonable amount of time, or on commercially reasonable terms, if at all.
Unavailability of necessary components could require us to re-engineer our products to accommodate available substitutions, which could increase costs to us and/or have a material adverse effect on our manufacturing schedules, products’ performance and market acceptance.
In addition, if we are unable to procure a component from one of our outside manufacturers, we may be required to enter into arrangements with one or more alternative manufacturing companies, which may cause delays in producing components or result in significant increase in expenses.
In addition, if we are unable to procure a component from one of our outside manufacturers, we may be required to enter into arrangements with one or more alternative manufacturing companies, which may cause delays in producing components or result in significant increase in expenses. 18 Table of Contents We are dependent on our suppliers and third-party manufacturers, including single-source and sole-source suppliers, and disruptions in our supply chain could adversely affect our ability to manufacture and deliver products.
Our business and operations could be negatively affected by securities litigation or stockholder activism, which could impact the trading price and volatility of our common stock and may constrain capital deployment opportunities and adversely impact our ability to expand our business.
Any judgments or settlements in any pending litigation or future claims, litigation or investigation could have a material adverse effect on our business, financial condition, or results of operations or the price of our common stock. 20 Table of Contents Our business and operations could be negatively affected by securities litigation or stockholder activism, which could impact the trading price and volatility of our common stock and may constrain capital deployment opportunities and adversely impact our ability to expand our business.
Additionally, such securities litigation 20 Table of Contents and stockholder activism could give rise to perceived uncertainties as to our future, adversely affect our relationships with service providers and make it more difficult to attract and retain qualified personnel.
Additionally, such securities litigation and stockholder activism could give rise to perceived uncertainties as to our future, adversely affect our relationships with service providers and make it more difficult to attract and retain qualified personnel. Also, we may be required to incur significant legal fees and other expenses related to any securities litigation and activist stockholder matters.
In addition, stockholder activism may constrain our capital deployment opportunities and may limit the types of investments that are available to us. Risks related to our acquisition strategy Our acquisitions expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies.
Risks related to our acquisition and divestiture activities Our acquisitions expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies.
As described in Item 9A — Controls and Procedures and elsewhere in this Form 10-K, Management identified material weaknesses in our internal control over financial reporting for the fiscal years ended December 31, 2024 and 2023. Effective internal control over financial reporting is necessary to provide reliable financial reports and to assist in the effective prevention of fraud.
As described in Item 9A — Controls and Procedures and elsewhere in this Form 10-K, Management concluded our disclosure controls and procedures were effective as of December 31, 2025. However, Management identified a material weakness in our internal control over financial reporting for the fiscal year ended December 31, 2024.
We may be required to incur significant expenses to comply with these regulations or to remedy any violations of these regulations. 19 Table of Contents Any failure by us to comply with applicable government regulations could also result in the cessation of our operations or portions of our operations, product recalls or impositions of fines and restrictions on our ability to carry on or expand our operations.
Any failure by us to comply with applicable government regulations could also result in the cessation of our operations or portions of our operations, product recalls or impositions of fines and restrictions on our ability to carry on or expand our operations. Healthcare reform measures could adversely affect our business and financial results.
Future regulations or voluntary actions on our part in response to climate change could result in costly changes to our facilities to reduce carbon emissions and could increase energy costs as a result of switching to less carbon-intensive, but more expensive, sources of energy to operate our facilities and to transport and ship products and samples.
They could also increase energy costs as a result of switching to less carbon-intensive, but more expensive, sources of energy to operate our facilities and to transport and ship products and samples.
Our products and services are subject to and affected by environmental regulation by federal, state, and local authorities in the United States and regulatory authorities with jurisdiction over our international operations.
Our products and services are subject to and affected by environmental regulation by federal, state, and local authorities in the United States and regulatory authorities with jurisdiction over our international operations. Future regulations or voluntary actions on our part in response to climate change could result in costly changes to our facilities to reduce carbon emissions.
ITEM 1A. RISK FACTORS Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all of the other information contained in this Annual Report, before deciding to invest in our common stock.
You should carefully consider the risks and uncertainties described below, together with all of the other information contained in this Annual Report, including our financial statements and related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding to invest in our common stock.
Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by the SEC, The NASDAQ Stock Market LLC or other regulatory authorities.
Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by the SEC, The Nasdaq Stock Market LLC or other regulatory authorities. Changes in tax laws and regulations could adversely affect our financial condition and results of operations. We are subject to regular examination by the U.S.
Also, we may be required to incur significant legal fees and other expenses related to any securities litigation and activist stockholder matters. Further, the price of our common stock could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and stockholder activism.
Further, the price of our common stock could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and stockholder activism. In addition, stockholder activism may constrain our capital deployment opportunities and may limit the types of investments that are available to us.
We may be unable to offset our taxable income with losses, or our tax liability with credits, before such losses and credits expire and therefore would incur larger federal income tax liability. Risks related to disruptive events Public health crises have adversely affected, and could in the future adversely affect, our business, financial condition. results of operations and cash flows.
We may be unable to offset our taxable income with losses, or our tax liability with credits, before such losses and credits expire and therefore would incur larger federal income tax liability. 30 Table of Contents Risks related to disruptive events Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of products, which could negatively affect our operations and performance.
There have been significant tariffs imposed on imported goods within the U.S. and there are currently indications that future tariffs are likely to be imposed. The imposition of such tariffs may strain international trade relations and increase the risk that foreign governments implement retaliatory tariffs on goods imported from the United States.
Throughout 2025 and during the first quarter of 2026, there have been significant tariffs imposed on imported goods within the United States and there are currently indications that future tariffs are likely to be imposed.
U.S. relations with the rest of the world remains uncertain with respect to taxes, trade policies and tariffs, especially under an increasingly volatile political landscape within the U.S. and abroad. Changes in U.S. administrative policy may lead to significant increases in tariffs for imported goods among other possible changes.
Our business is dependent upon the availability of supplies for our products. U.S. relations with the rest of the world remain uncertain with respect to taxes, trade policies, and tariffs, especially under an increasingly volatile political landscape within the United States and abroad.
Such access has led and could lead in the future to the compromise of sensitive, business, personal or confidential information or instructions to transfer funds by us or customers to unauthorized recipients. In the third quarter during the year ended December 31, 2022, we experienced an immaterial security breach that successfully redirected payments from our customers to unauthorized bank accounts.
Such access has led and could lead in the future to the compromise of sensitive, business, personal or confidential information or instructions to transfer funds by us or customers to unauthorized recipients. Although we have experienced security breaches in the past, none of these breaches have resulted in a material liability or loss to us.
However, elements of our remediation plans can only be accomplished over time and we can offer no assurance that these initiatives will ultimately have the intended effects. Any failure to establish and maintain effective internal control over financial reporting and disclosure controls and procedures could adversely impact our ability to report our financial results on a timely and accurate basis.
To address our material weaknesses, we had implemented the remediation plans described in Item 9A — Controls and Procedures in this Form 10-K. Any failure to establish and maintain effective internal control over financial reporting and disclosure controls and procedures could adversely impact our ability to report our financial results on a timely and accurate basis.
Furthermore, there is no guarantee that we will be successful in defending ourselves in pending or future litigation or similar matters under various laws. Any judgments or settlements in any pending litigation or future claims, litigation or investigation could have a material adverse effect on our business, financial condition, or results of operations or the price of our common stock.
Furthermore, there is no guarantee that we will be successful in defending ourselves in pending or future litigation or similar matters under various laws.
We are subject to the risk of disruption by earthquakes, floods and other natural disasters, fire, power shortages, geopolitical unrest, war, terrorist attacks and other hostile acts and other events beyond our control and the control of the third parties on which we depend.
Earthquakes, floods and other natural disasters, fire, power shortages, geopolitical unrest or other political conditions (including government shutdowns), wars and other military conflicts (such as the ongoing war in Ukraine, conflict in the Middle East and recent U.S. involvement in Venezuela), terrorist attacks and other hostile acts and other events beyond our control and the control of the third parties on which we depend could negatively affect our operations and performance.
In addition, the potential physical impacts of climate change on our operations are highly uncertain and would be particular to the geographic circumstances in areas in which we operate. These may include changes in global weather patterns, which could include local changes in rainfall and storm patterns and intensities, water shortages, changing sea levels, and changing temperature averages or extremes.
These impacts may include changes in global weather patterns, which could include local changes in rainfall and storm patterns and intensities, water shortages, changing sea levels, and changing temperature averages or extremes. These impacts may also adversely affect our properties, our business, financial condition and results of operations. ITEM 1B. UNRESOLVED STAFF COMMENTS None.
Risks related to our common stock 25 Table of Contents Our stock price and volume may be volatile, and purchasers of our securities could incur substantial losses.
Compliance with new or changing laws, regulations, or industry standards relating to AI may impose significant operational and financial burdens and may limit our ability to develop, deploy, or use AI technologies in our business. Risks related to our common stock Our stock price and volume may be volatile, and purchasers of our securities could incur substantial losses.
If we fail to obtain an alternative supplier for the components of our products, our operations could be disrupted. In addition, an uncorrected defect or supplier’s variation in a component or raw material, either unknown to us or incompatible with our manufacturing process, could harm our ability to manufacture products.
We might not be able to find a sufficient alternative supplier in a reasonable amount of time, or on commercially reasonable terms, if at all. If we fail to obtain an alternative supplier for the components of our products, our operations could be disrupted.
Our Board could rely on Delaware law to prevent or delay an acquisition of us. These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board, which is responsible for appointing the members of our management.
Our Board could rely on Delaware law to prevent or delay an acquisition of us.
As a result, the acquisition and integration of acquired businesses may not contribute to our earnings as expected and we may not achieve the other anticipated strategic and financial benefits of such transactions. Risks related to our intellectual property and cyber security Our proprietary rights may not adequately protect our technologies and products.
Any future divestitures may result in similar costs and risks. Risks related to our intellectual property, cyber security, and artificial intelligence Our proprietary rights may not adequately protect our technologies and products.
Ongoing and future conflicts and other geopolitical events may result in sanctions or other export controls imposed by the U.S. or United Nations. 30 Table of Contents As we increase sales in international markets, any such international instability and reduction in global trade could negatively impact our expansion plans and international sales.
Unfavorable currency exchange rate fluctuations may impact our operating margins, or may cause us to raise prices for our products and services, which could result in reduced sales. As we increase sales in international markets, any such international instability and reduction in global trade could negatively impact our expansion plans and international sales.
These political and economic changes could have a material effect on global economic conditions and the stability of financial markets and could significantly reduce global trade. In addition to potential increases on tariffs, wars or conflicts could affect our ability to obtain raw materials.
Political tensions resulting from changes in U.S. trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets and could significantly reduce global trade.