BLFS 10-K & 10-Q changes, risk factors and insider trading
Biolife Solutions Inc. · Nasdaq · Electromedical & Electrotherapeutic Apparatus · CIK 834365 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “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.”
New heading “Our recent divestitures expose us to ongoing risks and uncertainties, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or stock price.”
New heading “The development, deployment and use of AI technologies present new risks and challenges that could adversely impact our business.”
New heading “Changes in tax laws and regulations could adversely affect our financial condition and results of operations.”
New heading “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.”
Removed heading “We depend on outside suppliers for all our manufacturing supplies, parts and components.”
Largest changes
“We must also comply with complex foreign and U.S. laws and regulations, such as the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, and other local laws prohibiting corrupt payments to governmental officials, anti-competition regulations and sanctions imposed by the U.S. Office of Foreign Assets Control and other similar laws and regulations. …”see in full comparison
We and our customers are subject to various significant international, federal, state and local regulations, including but not limited to regulations in the areas of health and safety, employment, labor and immigration, import/export controls, trade restrictions and anti-competition. In addition, as an international organization, we are subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal, or sensitive data in the course of our business. The EU’s General Data Protectionsee in full comparisonRegulation,Regulationor GDPR,("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. Other governmental authorities around the world have passed or are considering similar types of legislative and regulatory proposals concerning data protection. 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,penaltiespenalties, and other damages.We must also comply with complex foreign and U.S. laws and regulations, such as the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, and other local laws prohibiting corrupt payments to governmental officials, anti-competition regulations and sanctions imposed by the U.S. Office of Foreign Assets Control and other similar laws and regulations. Violations of these laws and regulations could result in fines and penalties, criminal sanctions, restrictions on our business conduct and on our ability to offer our products in one or more countries, and could also materially affect our brand, our ability to attract and retain employees, our international operations, our business and our operating results. Although we have implemented policies and procedures designed to ensure compliance with these laws and regulations, there can be no assurance that our employees, contractors, or agents will not violate our policies. These regulations are complex, change frequently and have tended to become more stringent over time. We may be required to incur significant expenses to comply with these regulations or to remedy any violations of these regulations.
“In addition, in connection with the SciSafe Divestiture, we remain liable and responsible for the full performance and observance of all of the provisions, covenants, and conditions in one of SciSafe’s operating leases. In the case of a breach or violation of any provision of the lease by SciSafe Buyer, we are deemed to be in default of the lease provisions. Simultaneously, we received indemnification pursuant to any obligation owed by us under this operating lease. …”see in full comparison
“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. Ongoing and future conflicts and other geopolitical events may result in sanctions or other export controls imposed by the U.S. or United Nations.”see in full comparison
“The global supply chain is subject to disruption due to labor, geopolitical, trade and monetary issues, which may be exacerbated by ongoing instability in Ukraine and the Middle East. Although we have yet to experience any material effects of this impact on our supply chain or operations, we face the potential risk that upstream disruptions may occur. Risks relating to the lingering effects of global supply chain disruptions may even continue after current conflicts have subsided.”see in full comparison
“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.”see in full comparison
Full comparison: every changed paragraph (68)
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, 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. If any of the following risks materialize, our business, financial condition, results of operation and prospects will likely be materially and adversely affected. In that event, the market price of our common stock could decline and you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations or financial condition.
During the years ended December 31, 2025, 2024, 2023, and 2022,2023, we derived approximately 28%,29%, 25%,32%, and 32%29% of our revenue from twothree customers, respectively. In the years ended December 31, 2025, 2024, 2023, and 2022,2023, we derived approximately 73%,82%, 73%,80%, and 77%82% 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. 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 depend on outside suppliers for all our manufacturing supplies, parts and components.
We rely on outside suppliers, including several single-source suppliers, for all our manufacturing supplies, parts and components. 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. 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. 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. 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 currently manufacture all of our biopreservation media products and other related components. We currently outsource the manufacturing of certain thaw products, and certain cold chain products. Manufacturing our products is difficult and complex. To support our current and prospective clinical customers, we and our outsourcesoutsource manufacturers comply with, and intend to continue to comply with, cGMP in the manufacture of our products. Our ability to adequately manufacture and supply our products in a timely matter is dependent on the uninterrupted and efficient operation of our facilities and those of third parties manufacturing certain of our products or producing raw materials and supplies upon which we rely in our manufacturing. Manufacturing our products may be impacted by:
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.
We are dependent on our suppliers and third-party manufacturers to provide quality products and components. Some of the materials, supplies, and services used in our product manufacturing, as well as some of our products, are sourced from single- or sole-source suppliers. 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.
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. 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. 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.
The global supply chain is subject to disruption due to labor, geopolitical, trade and monetary issues, which may be exacerbated by ongoing instability in Ukraine and the Middle East. Although we have yet to experience any material effects of this impact on our supply chain or operations, we face the potential risk that upstream disruptions may occur. Risks relating to the lingering effects of global supply chain disruptions may even continue after current conflicts have subsided.
We and our customers are subject to various international governmental regulations. Compliance withwith, or changes inin, such regulations may cause us to incur significant expenses, and if we fail to maintain satisfactory compliance with certain regulations, we may be forced to recall products and cease their manufacture and distribution, and we could be subject to civil or criminal penalties.
We and our customers are subject to various significant international, federal, state and local regulations, including but not limited to regulations in the areas of health and safety, employment, labor and immigration, import/export controls, trade restrictions and anti-competition. In addition, as an international organization, we are subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal, or sensitive data in the course of our business. The EU’s General Data Protection Regulation,Regulation or GDPR,("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. Other governmental authorities around the world have passed or are considering similar types of legislative and regulatory proposals concerning data protection. 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, penaltiespenalties, and other damages. We must also comply with complex foreign and U.S. laws and regulations, such as the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, and other local laws prohibiting corrupt payments to governmental officials, anti-competition regulations and sanctions imposed by the U.S. Office of Foreign Assets Control and other similar laws and regulations. Violations of these laws and regulations could result in fines and penalties, criminal sanctions, restrictions on our business conduct and on our ability to offer our products in one or more countries, and could also materially affect our brand, our ability to attract and retain employees, our international operations, our business and our operating results. Although we have implemented policies and procedures designed to ensure compliance with these laws and regulations, there can be no assurance that our employees, contractors, or agents will not violate our policies. These regulations are complex, change frequently and have tended to become more stringent over time. We may be required to incur significant expenses to comply with these regulations or to remedy any violations of these regulations.
We must also comply with complex foreign and U.S. laws and regulations, such as the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, and other local laws prohibiting corrupt payments to governmental officials, anti-competition regulations and sanctions imposed by the U.S. Office of Foreign Assets Control and other similar laws and regulations. Violations of these laws and regulations could result in fines and penalties, criminal sanctions, restrictions on our business conduct and on our ability to offer our products in one or more countries, and could also materially affect our brand, our ability to attract and retain employees, our international operations, our business and our operating results. Although we have implemented policies and procedures designed to ensure compliance with these laws and regulations, there can be no assurance that our employees, contractors, or agents will not violate our policies. These regulations are complex, change frequently and have tended to become more stringent over time. We may be required to incur significant expenses to comply with these regulations or to remedy any violations of these regulations. 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.
In response to perceived increases in healthcare costs in recent years, the efforts of governmental and third-party payors to contain or reduce the costs of healthcare and, more generally, to reform the U.S. healthcare system may adversely affect the business and financial condition of pharmaceutical and biotechnology companies, including ours. 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. Efforts by governments and other third-party payors to contain or reduce the costs of healthcare through various means may limit our commercial opportunities and adversely affect our operating results and result in a decrease in the price of our common stock or limit our ability to raise capital. We anticipate additional uncertainty as debates about healthcare and public health continue.
We are and may become subject to various claims, including “whistleblower” complaints, litigation or investigations, including commercial disputes and employee claims, and from time to time may be involved in governmental or regulatory investigations or similar matters. Some of these claims may relate to the activities of businesses that we have acquired, even though these activities may have occurred prior to our acquisition of such businesses. Any claims asserted against us or our management, regardless of merit or eventual outcome, could harm our reputation, distract our management and have an adverse impact on our relationship with our existing or prospective clients, distribution partners and other third-partiesthird parties and could lead to additional related claims. 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.
Securities litigation and stockholder activism, including potential proxy contests, could result in substantial costs and divert management’sthe attention of our management and our board of director’sdirectors attention(our “Board”) and resources from our business. 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. 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.
Risks related to our acquisition strategyand divestiture activities
Even if we are able to successfully integrate acquired businesses, our ability to realize the anticipated business opportunities, growth prospects, cost savings, synergies, and other benefits of acquisitions depends on a number of factors including our ability to:
•leverage our infrastructure to sell and cross-market acquired products;
•drive adoption of acquired products in new markets;
•bring acquired products to new geographic markets;
•comply with new governmental regulations, including obtaining regulatory approvals in relevant markets;
•execute on development timelines for acquired products;
•manage inventories for product lines;
•carry, service, and manage significant debt and repayment obligations; and
•manage the unforeseen risks and uncertainties related to these transactions, including any related to intellectual property rights.
Many of these factors are outside of our control and any one of them could result in increased costs, decreased revenues, and diversion of management’s time and energy. The benefits of these transactions may not be achieved within the anticipated time frame or at all. Any of these factors could negatively impact our earnings per share, decrease or delay the expected accretive effect of the transaction, and negatively impact the price of our common stock.
Our recent divestitures expose us to ongoing risks and uncertainties, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or stock price.
In recent years, we completed several divestitures, including the SAVSU Transaction, the CBS Divestiture, the SciSafe Divestiture, and the Global Cooling Divestiture. These divestitures expose us to continued financial and operational risks, such as through retained liabilities and indemnification obligations, transition service obligations, potential disputes with buyers regarding purchase price adjustments or indemnification claims, loss of revenue and customers, stranded costs and inefficiencies, potential litigation and employee retention challenges.
For example, pursuant to the Global Cooling Purchase Agreement, we are required to indemnify Global Cooling for preexisting legal contingencies. Prior to the Global Cooling Divestiture, two lawsuits were filed by previous customers seeking payment for losses related to Global Cooling’s commercial freezer products. These lawsuits are described in further detail under Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
In addition, in connection with the SciSafe Divestiture, we remain liable and responsible for the full performance and observance of all of the provisions, covenants, and conditions in one of SciSafe’s operating leases. In the case of a breach or violation of any provision of the lease by SciSafe Buyer, we are deemed to be in default of the lease provisions. Simultaneously, we received indemnification pursuant to any obligation owed by us under this operating lease. This indicates we undertake the obligation to stand ready to perform over the term of the guarantee in the event of the specified triggering events noted above, or if conditions, such as breach or default, occur. However, the non-contingent aspect of the guarantee enables us to recover any losses from SciSafe Buyer.
These risks, or any future unforeseen risks, could have a material adverse impact on our business, financial condition, results of operations, cash flows or the price of our common stock.
Further, in connection with these divestitures, we incurred significant cash and non-cash expenses, including transaction costs, severance payments, earn-out or adjustment settlements, and stock compensation acceleration. Any future divestitures may result in similar costs and risks.
Even if we are able to successfully integrate acquired businesses, we may not be able to realize the revenue and other synergies and growth that we anticipated from the acquisition in the time frame that we expected, and the costs of achieving these benefits may be higher than what we expected. 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 propertyproperty, cyber security, and cyberartificial securityintelligence
Our technology is critical to the implementation of our business plan, and we are dependent on our patent rights and other intellectual property rights to maintain our competitive position. Our policy is to seek to protect our proprietary position and our commercial success will depend on our ability to obtain patents and/or regulatory exclusivity and maintain adequate protection for our technologies and products in the United States and other countries. We will be able to protect our proprietary rights from unauthorized use by third-partiesthird parties only to the extent that our proprietary technologies and products are covered by valid and enforceable patents or are effectively maintained as trade secrets.
Even if we are granted a patent, in certain circumstances we may be unable to protect our rights to, or use of, our technology.
Patent applications filed by third parties that cover technology similar to ours may have priority over our patent applications and could further require us to obtain rights to issued patents covering such technologies. If another party files a U.S. patent application on an invention similar to ours, we may elect to participate in or be drawn into an interference proceeding declared by the U.S. Patent and Trademark Office to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our U.S. patent position with respect to such inventions. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. We cannot predict whether third parties will assert these claims against us, or whether those claims will harm our business. If we are forced to defend against these claims, whether they are with or without any merit and whether they are resolved in favor of or against us, we may face costly litigation and diversion of management’s attention and resources. As a result of these disputes, we may have to develop costly non-infringing technology,technology or enter into licensing agreements. These agreements, if necessary, may be unavailable on terms acceptable to us, if at all, which could seriously harm our business or financial condition.
We employ individuals who previously worked with other companies, including our competitors or potential competitors. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information, including trade secrets or other proprietary information, of former employers or other third parties. We may also be subject to claims that former employers or other third parties have an ownership interest in our patents. Litigation may be necessary to defend against these claims. We may not be successful in defending these claims, and even if we are successful, litigation could result in substantial costcosts and be a distraction to our management and other employees. Any litigation or the threat thereof may adversely affect our ability to hire employeesemployees, and we may lose valuable intellectual property rights if we fail in defending any such claims. 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.
In conducting our business, we collect, process, transmit and store sensitive, proprietary and confidential information about our employees, customers, vendors, and other parties, including business and personal information, which may be entitled to protection under a number of regulatory regimes. This information may,may include, but is not limited to, account access credentials, credit and debit card numbers, bank account numbers, social security numbers, driver’s license numbers, names and addresses and other types of sensitive business or personal information. Some of this information is also processed and stored by our third-party service providers to whom we outsource certain functions and other agents, including our customers, which we refer to collectively as our associated third parties.
The frequency, intensity, and sophistication of cyberattacks and data security incidents has significantly increased in recent years and is constant. We are continually subject to cyberattacks and the risk of data security incidents, some of which have been successful. Such incidents include malicious third party attempts to identify and exploit system vulnerabilities and/or penetrate or bypass our security measures in order to gain unauthorized access to our networks and systems or those of our associated third parties. 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. InAlthough we have experienced security breaches in the thirdpast, quarternone duringof thethese yearbreaches endedhave Decemberresulted 31,in 2022,a wematerial experiencedliability anor immaterial security breach that successfully redirected payments from our customersloss to unauthorized bank accounts.us. As a result,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. These measures have been breached in the past, andHowever, we cannot be certain that theythese 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. Further, while we select our associated third parties carefully, and we seek to ensure that our customers adequately protect their systems and data, we do not control their actions and are not able to oversee their processes. Any problems experienced by our associated third parties, including those resulting from breakdowns or other disruptions in the services provided by such parties or cyber-attacks and security breaches, could adversely affect our ability to conduct our business and our financial condition.
The development, deployment and use of AI technologies present new risks and challenges that could adversely impact our business.
AI is increasingly being used across the global business landscape, including in the life sciences and healthcare industries. We are beginning to integrate AI and machine learning technologies into our business to enhance our operations, products, technology, and services and expect our use of AI to increase as the technology rapidly evolves and improves. However, AI presents risks and challenges that could adversely impact our business.
The development, deployment, and use of AI, including within the life sciences industry, is still in its early stages, where the use of insufficiently developed AI technologies and premature deployment practices could result in unintended outcomes that harm our business. AI technologies may be developed using inaccurate, incomplete, flawed or biased algorithms, training methodologies or data, which could result in competitive harm, regulatory penalties, legal liability, or brand or reputational harm. Further, a failure to timely and effectively use or deploy AI and integrate it into new product offerings and services could negatively impact our competitiveness, particularly ahead of evolving industry trends and evolving consumer demands, and require investments that increase our costs.
Laws and regulations regarding AI technologies are rapidly evolving as well, including in the areas of intellectual property, cybersecurity, privacy, and data protection. As such, it remains uncertain how AI laws and regulations will impact our business or the associated cost or risks related to compliance therewith or with respect to incorporating compliance mechanisms appropriately and effectively into our operations. 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.
The trading price and volume of our common stock, traded on the NASDAQNasdaq Capital Market,Market or NASDAQ,("Nasdaq") has been highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control. In addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of companies. These market fluctuations may also materially and adversely affect the market price of our common stock. For example, in the year ended December 31, 2024,2025, the highest intra-day sale price of our common stock on NASDAQNasdaq was $28.88$29.62 per share and the lowest intra-day sale price of our common stock on NASDAQNasdaq was $14.50$19.10 per share. Our highest trading day volume was 1,692,9001,625,800 shares traded and the lowest trading day volume was 106,600105,900 shares traded. We may continue to incur substantial increases or decreases in our stock price and volume in the foreseeable future.
We have never paid cash dividends on our common stock and do not anticipate paying cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors (the "Board"),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 current policy is to retain all funds and earnings for use in the operation and expansion of our business.
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 weaknessesweakness in our internal control over financial reporting for the fiscal yearsyear ended December 31, 20242024. andWhile 2023.this Effectivematerial weakness was remediated during the year ended December 31, 2025, effective internal control over financial reporting is necessary to provide reliable financial reports and to assist in the effective prevention of fraud. 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. Any system of internal controls, however well designed and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that the objectives of the system are met. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. 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. 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.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.
In the course of making our assessment of the effectiveness of internal control over financial reporting as of December 31, 2023, we identified several material weaknesses. Material weaknesses were identified in relation to (i) ineffective control environment attributed to the acquisition of six private companies in 2019 – 2021 without the proper internal control infrastructure in place, insufficient resources with the appropriate level of internal controls training, knowledge, and expertise to meet our financial reporting requirements and provide adequate oversight over the performance of internal controls, and turnover in the first half of 2023 in key positions, resulting in a delay in establishing control activities to effectively mitigate the risks; (ii) internal control procedures over certain financial statement areas; and (iii) change management controls over certain key financial systems.
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.
To address our material weaknesses, we havehad developed and begun to implementimplemented the remediation plans described in Item 9A — Controls and Procedures in this Form 10-K. 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. If our financial statements are not accurate, investors may not have a complete understanding of our operations or may lose confidence in our reported financial information. Likewise, if our financial statements are not filed on a timely basis as required by the SEC and The NASDAQNasdaq Stock Market LLC, we could face severe consequences from those authorities. In either case, it could result in a material adverse effect on our business or have a negative effect on the trading price of our common stock. Further, if we fail to remedy these deficiencies (or any other future deficiencies) or maintain the adequacy of our internal control over financial reporting and disclosure controls and procedures, we could be subject to regulatory scrutiny, civil or criminal penalties or shareholder litigation. We 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.
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. Internal Revenue Service and state, local and foreign tax authorities. We regularly assess the likelihood of favorable or unfavorable outcomes resulting from these examinations to determine the adequacy of our expense for income taxes. Although we believe our tax estimates are reasonable, there can be no assurance that any final determination will not be materially different from the treatment reflected in our historical income tax expenses and accruals, which could materially and adversely affect our financial condition and results of operations.
Our ability to utilize our NOL carryforwards to offset future taxable income may be limited by a lack of sufficient profits in the jurisdictions where these NOLs were generated. We have accumulated significant NOLs in various tax jurisdictions from historical operating losses, but if we do not generate adequate taxable income in those jurisdictions before the NOLs expire, we may be unable to fully utilize them, resulting in higher effective tax rates and increased cash tax payments in profitable periods. Tax laws in certain jurisdictions impose restrictions on NOL usage, such as annual utilization caps or requirements for income in the same entity or jurisdiction, which could further constrain our ability to offset taxes.
Our ability to use net operating lossNOL 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 lossNOL and tax credit carryforwards.
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 lossNOL and tax credit carryforwards and certain built-in losses recognized in years after the ownership change. These rules generally operate by focusing on ownership changes involving stockholders owning directly or indirectly 5% or more of the stock of a company and any change in ownership arising from a new issuance of stock by us. Generally, if an ownership change occurs, the yearly taxable income limitation on the use of net operating lossNOL 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. 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.
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. 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. 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.
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. 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. While many of these tariffs have been suspended or reduced temporarily, the imposition of such tariffs may strain international trade relations and has led to foreign governments implementing retaliatory tariffs on goods imported from the United States.
Management's Discussion & Analysis (MD&A)
New heading “Cost of revenue and Gross margin”
New heading “Operating expenses”
Removed heading “Product revenue”
Removed heading “Service revenue”
Removed heading “Costs and operating expenses”
Removed heading “Cost of product, rental, and service revenue”
Largest changes
The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities at the reporting date and revenues and expenses during the reporting periods. These estimates represent management's judgment about the outcome of future events.see in full comparisonTheMacroeconomicglobalfactors,businessgeopoliticalenvironmentunrest,continuesinflation,tochangesbeinimpactedinterestbyandcostforeignpressure,currencytheexchangeoverall effects of economic uncertainty on customers' purchasing patterns, increasingrates, tariffsonandU.S.retaliatoryimports,measures,high interest rates,war and otherfactors.military conflict, and other risks and uncertainties have in the past and may continue to cause logistical challenges, increased input costs, or create constraints for our suppliers, distributors, or customers that could in turn 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. It is not possible to accurately predict the future impact of such events and circumstances. Actual results could differ from our estimates.
“R&D expenses decreased $0.8 million in the year ended December 31, 2024, or 14%, compared with the year ended December 31, 2023. The decrease is primarily due to a decrease of $0.6 million in research milestone costs related to our historical PanTHERA Development and License Agreement (as defined in Note 2: Acquisition within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report) in addition to a decrease of $0.5 million in stock-based compensation when compared to the prior year. …”see in full comparison
“In the year ended December 31, 2023, our operating activities used cash of $12.5 million reflecting a net loss of $68.0 million and non-cash charges totaling $55.5 million primarily related to stock-based compensation, impairment of assets, depreciation, amortization, changes in fair value of contingent consideration, gain on settlement of Global Cooling escrow, and non-cash lease charges. …”see in full comparison
Full comparison: every changed paragraph (83)
Our current portfolio of bioproduction products and services is comprised of one revenue line that contains three main offerings:
•Cell processing and other products
◦Biopreservation media
◦Human platelet lysate media (“hPL”), cryogenic cryogenic and ultralow temperature containers, and automated cell-processing fill machines ◦Automated thawing devices On October 6, 2025, the Company entered into the SAVSU Purchase Agreement by and between the Company and the SAVSU Buyer for the sale by the Company of all SAVSU Interests to the SAVSU Buyer. Upon the execution of the SAVSU Purchase Agreement, the SAVSU business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented. See Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report for further details regarding the divestiture.
On April 4, 2025, pursuant to the PanTHERA Purchase Agreement by and among the Company, the PanTHERA Sellers, the PanTHERA Buyer Sub, and Dr. Jason Acker, solely in his capacity as Sellers’ Representative, the Company acquired the remaining 90% of the issued and outstanding shares of common stock of PanTHERA not owned by the Company in the PanTHERA Transaction. See Note 2: Acquisition within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report for further details regarding the transaction.
Our current portfolio of bioproduction products and services are comprised of two revenue lines that contain four main offerings: (i) cell processing (including biopreservation media for the preservation of cells and tissues, human platelet lysate media for the supplementation of cell expansion, cryogenic vials and automated fill machines that provide high-quality, efficient, and precise mixes of solutions) and (ii) Evo and ThawSTAR devices (including “smart”, cloud connected devices for transporting biologic payloads and automated thawing systems).
We currently operate as one bioproduction products and services business which supports several steps in the biologic material manufacturing and delivery process. We have a diversifiedOur portfolio of tools and services that focuses on biopreservation,biopreservation media and cell processing,processing and thawing of biologic materials.products. We have in-house expertise in cryobiology and the broader CGT workflow, and continue to evaluate opportunities to maximize the value of our product platforms for our extensive customer base through organic growth innovations, partnerships, and acquisitions.
We have identified the policies and estimates below as being critical to our business operations and the understanding of our results of operations. These policies require management’s most difficult, subjective, or complex judgements,judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. The impact of any associated risks related to these policies on our business operations are discussed throughout “Management’s Discussion and Analysis of Financial Condition,” including in the “Results of Operations” section, where such policies affect our reported and expected financial results. Although we believe that our estimates, assumptions, and judgementsjudgments are reasonable, they are based upon information presently available. Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions.
The Company primarily recognizes product revenues, service revenues, and rental revenues. Product revenues are generated from the sale of biopreservation media and ThawSTARcell products.processing tools. We recognize product revenue, including shipping and handling charges billed to customers, at a point in time when we transfer control of our products to our customers.customers, which is upon shipment for substantially all transactions. Shipping and handling costs are classified as part of cost of product revenue in the Consolidated StatementStatements of Operations.
Any remaining revenues earned, which primarily consisted of service revenues generated from various customer service agreements for the provision of warranty and other engineering services and equipment rental arrangement revenues, were not significant in any of the periods presented.
Service revenues are generated from various customer service agreements to provide warranty and other engineering services. We recognize service revenues over time as services are performed or ratably over the contract term. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing the expected value method or the most likely amount method, depending on the facts and circumstances relative to the contract. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component or variable consideration as of and during the years ended December 31, 2024, 2023, and 2022.
The Company also generates revenue from the leasing of our evo cold chain systems to customers pursuant to rental arrangements entered into with the customer. Revenue from these arrangements is not within the scope of FASB ASC Topic 606 as it is within the scope of FASB ASC Topic 842, Leases. All customers leasing shippers currently do so under rental arrangements for durations of one year or less, with each unit having the option to continue its rental arrangement on a month-to-month basis until returned to the Company beyond the initial rental period. We account for these rental transactions as operating leases and record rental revenue on a straight-line basis over the rental term.
During the year ended December 31, 2023, all contingent consideration liabilities were written off upon assessment of the probabilityconclusion that we would not achieve certain revenue targets for earnouts. For additional details on the factors considered in the write-off, see Note 4: Fair value measurement within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
We expense stock-based compensation for stock options,options and restricted stock awards, and performance awards over the requisite service period. For awards with only a service condition, we expense stock-based compensation using the straight-line method over the requisite service period for the entire award. For awards with a market condition, we expense the grant date fair value over the vesting period regardless of the value that the award recipients will ultimately receive. For awards with performance conditions, we begin expensing the grant date fair value over the requisite vesting period only when the performance condition is deemed probable.
We have, from time to time, modified the terms of restricted stock awards awarded to employees. We account for the incremental increase in the fair value over the original award on the date of the modification as an expense for vested awards or over the remaining service (vesting) period for unvested awards. The incremental compensation cost is the excess of the fair value of the modified award on the date of modification over the fair value of the original award immediately before the modification.
The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In its evaluation, the Company considered its cumulative loss and its forecasted losses in the near-term as significant negative evidence. Based upon a review of the four sources of income identified within Accounting Standard Codification ("ASC") 740, Accounting for Income Taxes, the Company determined that the Company’s recorded deferred tax liabilities as of December 31, 20242025 would be a sufficient source of taxable income to realize all of its deferred tax assets except for a portion of its net operating lossNOL carryforwards. As a result, a full valuation allowance on its deferred tax assets was recorded as of December 31, 2024.2025. The Company will continue to assess the realizability of its assets going forward and will adjust the valuation allowance as needed.
As of December 31, 2024,2025, the Company had U.S. federal net operating loss (“NOL”) carryforwards of approximately $165.2$168.4 million, which is available to reduce future taxable income. Approximately $38.7$38.6 million of NOLNOLs will expire from 20252026 through 2037, and approximately $126.5$129.8 million of NOLNOLs will be carried forward indefinitely. The NOL carryforwards are subject to an annual limitation in the event of certain cumulative changes in the ownership interest. This limits the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. Subsequent ownership changes may further affect the limitation in future years.
RevenueTotal revenue for the years ended December 31, 2025, 2024, 2023, and 20222023 wereis comprisedpresented of the followingbelow:
Product revenue
Total product revenue was $76.0 million for the year ended December 31, 2024, representing an increase of $7.1 million, or 10%, compared with the year ended December 31, 2023. The increase in product revenue was primarily driven by the $7.7 million, or 12%, increase in cell processing products from an increase in customer demand when compared to the prior year. During the third and fourth quarters of 2023, we experienced a decrease in our revenues from our customers destocking inventory levels in addition to decreases in broader biotech funding that we did not experience during the year ended December 31, 2024. The increase in product revenue for the year ended December 31, 2024 was partially offset by a decrease of $0.6 million, or 19% in product revenues from our Evo and thaw product line when compared with the year ended December 31, 2023. The decrease was primarily driven by lower volumes of consumable products sold from our evo product line.
Total product revenue was $69.0 million for the year ended December 31, 2023, representing a decrease of $2.7 million, or 4%, compared with the year ended December 31, 2022. The decrease in product revenue was primarily driven by the $2.7 million, or 4%, decrease in cell processing products due to the decrease in broader biotech funding that impacted this revenue stream during the second half of 2023.
Service revenue
Service revenues, which are primarily generated from various customer service agreements to provide warranty and other engineering services, were an immaterial portion of our total revenues earned in the years ended December 31, 2024, 2023, and 2022.
Rental revenueRevenue
Rental revenue was $6.1 million for the year ended December 31, 2024, representing a decrease of $0.5 million, or 7%, compared with the year ended December 31, 2023. The decrease in rental revenue can be attributed to a decrease in fleet size from our largest customer of evo products during the current year.
RentalTotal revenue was $6.5$96.2 million for the year ended December 31, 2023,2025, representing an increase of $2.3$21.6 million, or 55%,29%, compared with the year ended December 31, 2022.2024. The increase in rental revenue canwas beprimarily attributeddriven by a $19.3 million, or 30%, increase in biopreservation media products from an increase in demand from customers with commercially approved therapies when compared to commercialthe expansionsprior from our largest customers.year.
Total revenue was $74.6 million for the year ended December 31, 2024, representing an increase of $6.6 million, or 10%, compared with the year ended December 31, 2023. The increase in revenues was primarily driven by the $4.8 million, or 8%, increase in biopreservation media products due to the increase in customer demand when compared to the prior year. From the third and fourth quarters of 2023 through the first and second quarters of 2024, we experienced a decrease in our revenue from our customers destocking inventory levels in addition to decreases in broader biotech funding, which strongly recovered during the third and fourth quarters of the year ended December 31, 2024.
Cost of revenue and Gross margin
Costs and operating expenses
In the year ended December 31, 2025, cost of revenue increased $9.5 million, or 39%, from the year ended December 31, 2024. This increase is driven by our 29% increase in overall sales volume in addition to lower yields on biopreservation bags. Additionally, scrap increased as a percentage of revenue in 2025 due to an inventory reserve in Q3 2025 and an increased rate of disposal of expired raw material and finished goods inventory.
Gross margin was 65% and 67% for the years ended December 31, 2025 and 2024, respectively. The decrease in gross margin can be attributed to an increase in costs of materials and overhead due to a less favorable product mix.
Cost of product, rental, and service revenue
In the year ended December 31, 2024, cost of product, rental, and service revenue decreased $1.3$2.1 million, or 4%,8%, from the year ended December 31, 2023. This decrease can be attributed to a $1.6 million decrease in supply expenses, a more favorable product mix,mix and increased operational efficiencies. The decrease in cost of product, rental, and service revenue was offset by a $0.2 million increase in shipping expenses compared to the year ended December 31, 2023.
CostGross ofmargin product,was rental,67% and service revenue as a percentage of revenue, inclusive of intangible asset amortization, was 38% and 43%61% for the years ended December 31, 2024 and 2023, respectively. The decreaseincrease in costgross of product, rental, and service revenues inclusive of intangible asset amortization as a percentage of revenuemargin can be attributed to a more favorable product mix in our biopreservation media product line and a decrease in supply expenses.
Operating expenses
Cost of product, rental, and service revenue as a percentage of revenue, inclusive of intangible asset amortization, was 38% for the year ended December 31, 2022. The increase in cost of product, rental, and service revenues inclusive of intangible asset amortization as a percentage of revenue for the year ended December 31, 2023 compared with the year ended December 31, 2022 can be attributed to unfavorable inventory adjustments of $1.8 million, partially offset by a decrease in material expenses from decreased revenues.
In the year ended December 31, 2024,2025, G&A expenses decreasedincreased by $2.7$4.9 million, or 6%,12%, compared with the year ended December 31, 2023.2024. The decreaseincrease is primarily driven by aincreases decreasein ofpersonnel $1.4expenses, including $5.1 million in stock compensation expenses, $0.8 million in severance expenses related to the departure of the former CEOexecutives, inand the prior year in addition to a decrease of $3.8$0.4 million in consultingsalaries. We also experienced increases of $0.5 million in acquisition costs and $0.4 million in lease expenses. The decreasesincreases in G&A expenses for the year ended December 31, 20242025 were primarily offset by a $1.6$2.7 million increasedecrease in bonusestimated expensessales andtax aexpense $0.5 million increase in insurance expensesas compared withto theprior year ended December 31, 2023.years.
G&A expenses decreased $2.2 million, or 5%, during the year ended December 31, 2024 compared with the year ended December 31, 2023. The decrease was primarily driven by a decrease of $1.4 million in severance expenses related to the departure of the former CEO in the prior year in addition to a decrease of $3.8 million in consulting expenses. The decreases in G&A expenses for the year ended December 31, 2024 were offset by increases in personnel expenses, including $1.6 million increase in bonus expenses and a $1.5 million increase in salaries compared with the year ended December 31, 2023.
G&A expenses increased $10.0 million, or 30%, during the year ended December 31, 2023 compared with the year ended December 31, 2022. The increase was driven by higher costs related to the expansion of our corporate infrastructure, including an increased headcount resulting in a $1.2 million increase in salary expenses and a $1.9 million increase in stock compensation expenses. The departure of the former CEO during 2023 also increased severance expenses by $1.4 million. Finally, we also experienced increases in professional fees related to potential merger activities of $3.6 million and increases in accounting fees of $0.6 million.
S&M expense decreased $3.1 million in the year ended December 31, 2024, or 24%, compared with the year ended December 31, 2023. The decrease is primarily due to decreases in personnel expenses, including stock-based compensation expenses of $1.8 million and $0.8 million in salaries from reduced headcount, and a $0.3 million decrease in consulting expenses.
S&M expense increased $1.0$0.9 million, or 9%,million in the year ended December 31, 2023,2025, or 10%, compared with the year ended December 31, 2022.2024. The increase is primarily due to an increaseincreases in personnel expenses,expenses of $0.6 million, including stock-based compensation expenses,expenses of $1.2$0.2 million.
S&M expense decreased $2.4 million, or 21% in the year ended December 31, 2024, compared with the year ended December 31, 2023. The decrease was primarily due to decreases in personnel expenses, including stock-based compensation expenses of $1.5 million and $0.5 million in salaries from reduced headcount. There was additionally decreases of $0.3 million in consulting expenses.
During the years ended December 31, 2025, 2024, and 2023, and 2022, research and development (“R&D”) expense consisted primarily of personnel-related costs, consulting, research supplies, and milestone expenses related to third partythird-party research agreements.
R&D expense decreased $4.2 million in the year ended December 31, 2024, or 34%, compared with the year ended December 31, 2023. The decrease is primarily due to decreases in personnel expenses, including stock-based compensation expenses, of $2.4 million, a decrease of $0.9 million in salaries, and a decrease of $0.6 million in severance costs from reduced headcount compared to the prior fiscal year.
R&D expensesexpense increased $3.4$2.8 million in the year ended December 31, 2023,2025, or 39%,59%, compared with the year ended December 31, 2022.2024. The increase is primarily due to an increaseincreases in personnel expenses, including stock-based$1.1 compensation expenses, of $2.2 million, increasesmillion in severancesalaries costsfrom ofan $0.6increased million,headcount, $0.9 million in stock-based compensation, and a $0.4$0.5 million increase in researchbonus milestone payments in relation to our equity investment in iVexSol.expenses.
R&D expenses decreased $0.8 million in the year ended December 31, 2024, or 14%, compared with the year ended December 31, 2023. The decrease is primarily due to a decrease of $0.6 million in research milestone costs related to our historical PanTHERA Development and License Agreement (as defined in Note 2: Acquisition within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report) in addition to a decrease of $0.5 million in stock-based compensation when compared to the prior year. The decrease in R&D expenses for the year ended December 31, 2024 was offset by a $0.3 million increase in product testing expenses compared with the year ended December 31, 2023.
IPR&D expense
In-process research and development ("IPR&D") expense during the year ended December 31, 2025 consists of the immediate $15.5 million expense of the IPR&D asset we acquired in the PanTHERA Transaction. For additional information on the details of the PanTHERA Transaction, see Note 2: Acquisition within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
Amortization expense consists of charges related to the amortization of intangible assets associated with theprevious acquisitions of Sexton, SAVSU Technologies, Inc. (“SAVSU”), and Astero in which we acquired definite-lived intangible assets.
Interest expense,income net.(expense), net
Other income
Other income consists of various non-cash income and expenses, primarily reflecting activity in the accretion or amortization of our available-for-sale securities and other investments. The increase in other income during the year ended December 31, 2025 is primarily due to increased income from the accretion of our available-for-sale securities in addition to the increase in the balance of our financial instruments measured at fair value.
Change in fair value of investments.investments
Gain on settlement of Global Cooling escrow.escrow
Reflects the non-cash gain associated with our post-closing adjustments for indemnifications and negotiated terms in connection with our acquisition of Global Cooling in 2023,Cooling, and subsequent release and cancellation of these shares of our common stock from the third-party escrow account established in connection with that transaction.transaction in 2023. For additional information, see Note 1211 within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
Income Tax Expense (Benefit)
The income tax expense (benefit) recognized in the year ended December 31, 20242025 primarily related to losses generated in 2024.2025. Our effective tax rate for 20242025 was lower than the U.S. statutory rate of 21% primarily due to the change in our valuation allowance.
Significant cash and non-cash expenses related to acquisitions and divestitures
On April 17, 2024, we consummated the Global Cooling Divestiture. In connection with the closing of the transaction, we provided $6.7 million in cash funding to effectuate the transaction and paid $0.6 million to the brokers, attorneys, and other external parties. In addition, we recognized $6.1 million in cash expenditures from operations during the third quarter of 2024 to meet certain post-closing requirements, costs to sell Global Cooling, the assumption of certain liabilities and debt, and severance expenses related to the Reduction in Force ("RIF") implemented on the business of Global Cooling, which reduced our workforce by 47 employees. For additional information on the details of this transaction, the RIF and its related costs, see Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
On November 12, 2024, we consummated the SciSafe Divestiture. In connection with the closing of this transaction, we received net proceeds of $71.3 million. We also incurred additional expenses related to this transaction, including $0.5 million to the brokers, attorneys, and other external parties for legal and other transaction services, and incurred $0.4 million in severance costs. We also paid the former stockholders of SciSafe approximately $3.3 million in cash to waive all rights with respect to certain potential earn-out payments and recognized $4.0 million in stock compensation expense in connection with the acceleration of unvested shares for all of our former employees that remained with SciSafe upon the closing of this transaction. For additional information on the divestiture of SciSafe, see Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
What changed in the latest 10-Q
Risk Factors
There have been no material changes to the risk factors described in Part I, Item 1A of our Annual Report.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
“On June 1, 2026 our Term Loan (as defined in Note 12: Long-term debt, to the Unaudited Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q) matured and the Company paid in full the remaining principal balance on the Term Loan in addition to a balloon payment of $1.2 million.”see in full comparison
“On July 21, 2026, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) by and among, the Company, Repligen Corporation, a Delaware corporation (“Repligen”), Bravo Merger Sub I, Inc., a Delaware corporation and wholly owned subsidiary of Repligen (“Merger Sub 1”) and Bravo Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of Repligen (“Merger Sub 2”), pursuant to which Repligen will acquire, subject to the satisfaction or waiver of the conditions contained in the Merger Agreement, all of the outstanding shares of the Company’s …”see in full comparison
“On July 21, 2026, we entered into the Merger Agreement with Repligen, Merger Sub 1, and Merger Sub 2, pursuant to which Repligen will acquire, subject to the satisfaction or waiver of the conditions contained in the Merger Agreement, all of our outstanding shares of Common Stock, for $11.25 cash and 0.1442 shares of Repligen’s common stock, on a per share basis. In connection with the Merger Agreement, we could be required to pay a termination fee of approximately $59.0 million under specified circumstances in the Merger Agreement. …”see in full comparison
see in full comparisonGrossCostmarginofdecreasedrevenuebyincreased3%$4.7 million, or 31%, for thethreesix months endedMarchJune31,30, 2026 compared to the same period in 2025. ThedecreaseincreaseisduringprimarilytheduethetosixamonthslessendedfavorableJuneproduct30,mix2026 was largely driven by the increase in sales compared to the same period in the prioryear.year in addition to an increase in sales in lower margin products.
“IPR&D expense during the three and six months ended June 30, 2025 consists of the immediate $15.5 million expense of the IPR&D asset we acquired in the PanTHERA Transaction. For additional information on the details of the PanTHERA Transaction, see Item I, Note 2: Acquisition within the Consolidated Financial Statements of this Quarterly Report on Form 10-Q.”see in full comparison
“G&A expenses increased $0.3 million, or 1%, for the six months ended June 30, 2026 compared to the same period in 2025. The increase for the six months ended June 30, 2026 is primarily driven by an increase in acquisition and consultation costs compared to the same period during the prior year, partially offset by a decrease in stock compensation expenses.”see in full comparison
Full comparison: every changed paragraph (34)
On July 21, 2026, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) by and among, the Company, Repligen Corporation, a Delaware corporation (“Repligen”), Bravo Merger Sub I, Inc., a Delaware corporation and wholly owned subsidiary of Repligen (“Merger Sub 1”) and Bravo Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of Repligen (“Merger Sub 2”), pursuant to which Repligen will acquire, subject to the satisfaction or waiver of the conditions contained in the Merger Agreement, all of the outstanding shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), for $11.25 cash and 0.1442 shares of Repligen’s common stock, on a per share basis. Pursuant to the Merger Agreement, following consummation of the Merger, we will be a wholly-owned subsidiary of Repligen. As a result of the Merger, we will cease to be a publicly traded company. For additional information on the Merger Agreement, see Note 18: Subsequent events within the Unaudited Condensed Consolidated Financial Statements of this Quarterly Report on Form 10-Q.
On October 6, 2025, the Company entered into a Limited Liability Company Membership Interest Purchase Agreement (the “SAVSU Purchase Agreement”), by and between the Company and Peli BioThermal LLC, a Delaware limited liability company (“SAVSU Buyer”), for the sale by the Company of all of the issued and outstanding limited liability company membership interests (the “SAVSU Interests”) of SAVSU Cleo Technologies, LLC, a Delaware limited liability company ("SAVSU"), to SAVSU Buyer (the “SAVSU Divestiture”). SAVSU contained our evo cloud connected “smart” shipping container products that provided passive storage and transport for temperature-sensitive biologics and pharmaceuticals. Upon the execution of the SAVSU Purchase Agreement, the SAVSU business is presented in the accompanying Unaudited Condensed Consolidated Financial Statements as a discontinued operation for all periods presented.
Upon the execution of the SAVSU Purchase Agreement, the SAVSU business is presented in the accompanying Unaudited Condensed Consolidated Financial Statements as a discontinued operation for all periods presented.
During the three months ended March 31, 2026, we changed our inventory valuation method. At December 31, 2025, we valued biopreservation media inventory at cost or, if lower, net realizable value, using the specific identification method. For thaw inventory, we utilized cost or, if lower, net realizable value, using the average costing method. All other inventory was valued using cost or, if lower, net realizable value, using the first-in, first-out method. As of March 31, 2026,2026 and subsequent periods, all inventories are now valued at cost or, if lower, net realizable value, using the weighted average costing method. We believe this change is preferable as it provides a consistent, uniform costing method for all inventories across the Company and improves comparability with peers. These changes did not have a material effect on inventory, net, cost of revenue, or net income for all periods presented; therefore, prior comparative financial statements have not been restated.
Total revenue for the three and six months ended MarchJune 31,30, 2026 and 2025 consisted of the following:
Revenue was $27.5$28.5 million for the three months ended MarchJune 31,30, 2026, representing an increase of $5.4$5.0 million, or 25%,21%, compared with the same period in 2025. The increase in product revenues for the three months ended March 31, 2026 was largely driven by an increase in customer demand for our biopreservation media products compared to the same period in the prior year.
Revenue was $56.0 million for the six months ended June 30, 2026, representing an increase of $10.5 million, or 23%, compared with the same period in 2025.
The increase in revenues for both the three and six months ended June 30, 2026 compared to the same periods in the prior year is largely driven by an increase in customer demand for our biopreservation media products.
Total costs and operating expenses for three and six months ended MarchJune 31,30, 2026 and 2025 were composed of the following:
Cost of revenue increased $2.8$2.0 million, or 38%,24%, for the three months ended MarchJune 31,30, 2026 compared to the same period in 2025. The increase during the three and six months ended MarchJune 31,30, 2026 is primarily due to the increase in sales compared to the same period in the prior year in addition to an increase in sales in lower margin products.
GrossCost marginof decreasedrevenue byincreased 3%$4.7 million, or 31%, for the threesix months ended MarchJune 31,30, 2026 compared to the same period in 2025. The decreaseincrease isduring primarilythe duethe tosix amonths lessended favorableJune product30, mix2026 was largely driven by the increase in sales compared to the same period in the prior year.year in addition to an increase in sales in lower margin products.
Gross margin decreased by 1% for the three months ended June 30, 2026 compared to the same period in 2025.
Gross margin decreased by 2% for the six months ended June 30, 2026 compared to the same period in 2025.
The decrease in Gross margin for both the three and six months ended June 30, 2026 compared to the same periods in the prior year is primarily due to a less favorable product mix compared to the same period in the prior year.
G&A expenses increaseddecreased $0.9$0.5 million, or 8%,5%, for the three months ended MarchJune 31,30, 2026 compared to the same period in 2025. The increasedecrease for the three months ended MarchJune 31,30, 2026 is primarily driven by ana increasedecrease in personnelstock costs,compensation including stock-based compensation. These increases were offset by a reduction in acquisition costsexpenses compared to the same period during the prior year.year, partially offset by an increase in acquisition costs.
G&A expenses increased $0.3 million, or 1%, for the six months ended June 30, 2026 compared to the same period in 2025. The increase for the six months ended June 30, 2026 is primarily driven by an increase in acquisition and consultation costs compared to the same period during the prior year, partially offset by a decrease in stock compensation expenses.
S&M expenses increased $83$0.2 thousand,million, or 3%,8%, for the three months ended MarchJune 31,30, 2026. The increase for the three months ended MarchJune 31,30, 2026 is primarily due to an increase in salariesconsultation costs compared to the same period in the prior year, partially offset by a decrease in spend on advertising materials.year.
S&M expenses increased $0.3 million, or 6%, for the six months ended June 30, 2026. The increase for the six months ended June 30, 2026 is primarily due to an increase in consultation and personnel expenses.
R&D expenses increased $1.2$1.0 million, or 84%,51%, for the three months ended MarchJune 31,30, 2026 compared to the same period in 2025. The increase for the three months ended MarchJune 31,30, 2026 is primarily driven by an increase in testing costs and personnel costs from thean increase in headcount related to the acquisition of PanTHERA during the prior year.headcount.
R&D expenses increased $2.2 million, or 65%, for the six months ended June 30, 2026 compared to the same period in 2025. The increase for the six months ended June 30, 2026 is primarily driven by an increase in personnel costs, including stock compensation, from an increase in headcount in addition to an increase in depreciation expense.
IPR&D expense
IPR&D expense during the three and six months ended June 30, 2025 consists of the immediate $15.5 million expense of the IPR&D asset we acquired in the PanTHERA Transaction. For additional information on the details of the PanTHERA Transaction, see Item I, Note 2: Acquisition within the Consolidated Financial Statements of this Quarterly Report on Form 10-Q.
Total other income for the three and six months ended MarchJune 31,30, 2026 and 2025 was composed of the following:
Interest income, net incurred during the three and six months ended MarchJune 31,30, 2026 related primarily to the Term Loan (as defined in Note 12: Long-term debt, to the Unaudited Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q) and indirect tax liabilities. We also earn interest on cash held in our money market account and available-for-sale securities. The increase in our interest income, net during the three and six months ended MarchJune 31,30, 2026 can be attributed to the increases in interest income from our available-for-sale securities compared to the same periods in 2025 in addition to decreasesthe inmaturity of our long-term debt balance,balance during the three months ended June 30, 2026, decreasing interest expenses when compared to the same periods in 2025.
Other income consists of various non-cash income and expenses, primarily reflecting activity in the accretion or amortization of our available-for-sale securities and other investments. The increasedecrease in other income during the three and six months ended MarchJune 31,30, 2026 is primarily due to increaseda incomedecreased fromamount theof accretion of our available-for-sale securities ininvestments additioncompared to the increasesame periods in the balanceprior of our financial instruments measured at fair value.year.
On MarchJune 31,30, 2026 and December 31, 2025, we had $111.5$113.1 million and $120.2 million in cash, cash equivalents, and available-for-sale securities, respectively.
On July 21, 2026, we entered into the Merger Agreement with Repligen, Merger Sub 1, and Merger Sub 2, pursuant to which Repligen will acquire, subject to the satisfaction or waiver of the conditions contained in the Merger Agreement, all of our outstanding shares of Common Stock, for $11.25 cash and 0.1442 shares of Repligen’s common stock, on a per share basis. In connection with the Merger Agreement, we could be required to pay a termination fee of approximately $59.0 million under specified circumstances in the Merger Agreement. We do not believe that if we were required to pay such termination fee that these restrictions would prevent us from meeting our ongoing costs of operations, working capital needs, or capital expenditure requirements. For additional information on the Merger Agreement, see Note 18: Subsequent events within the Unaudited Condensed Consolidated Financial Statements of this Quarterly Report on Form 10-Q.
On June 1, 2026 our Term Loan (as defined in Note 12: Long-term debt, to the Unaudited Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q) matured and the Company paid in full the remaining principal balance on the Term Loan in addition to a balloon payment of $1.2 million.
Net cash (used in) provided by operating activities
Net cash usedprovided inby operating activities was $0.5$5.9 million during the threesix months ended MarchJune 31,30, 2026 compared to $1.7$9.1 million provided by operating activities during the threesix months ended MarchJune 31,30, 2025. The increasedecrease in net cash usedprovided inby operating activities was primarily due to the timing of collection and disbursement of working capital related items in accounts receivable, inventories, and accountsaccrued payable.expenses.
Net cash used in investing activities totaled $1.8$3.4 million during the threesix months ended MarchJune 31,30, 2026 compared to $27.2$66.7 million used in investing activities for the threesix months ended MarchJune 31,30, 2025. The decrease in net cash used in investing activities was primarily driven by a decrease of $10.0$28.9 million in purchases of our investments in available-for-sale marketable securities.securities compared to the same period in the prior year and the $10.2 million in cash we invested in the prior year on the IPR&D asset of PanTHERA. There was additionally an increase of $13.4$20.2 million in maturities of available-for-sale securities, providing a greater offset to purchases of available for sale securities than in the prior year.
Net cash used in financing activities totaled $7.9$11.5 million during the threesix months ended MarchJune 31,30, 2026, compared to $3.0$5.9 million used in financing activities during the threesix months ended MarchJune 31,30, 2025. The increase in net cash used in financing activities was primarily the result of our election to cover minimum statutory tax withholding obligations for the vesting of share based awards in cash rather than through sell-to-cover transactions. This used $5.6$6.7 million in cash compared to the prior year. For additional information on our election, see Note 13: Stock-based compensation within the Unaudited Condensed Consolidated Financial Statements of this Quarterly Report on Form 10-Q.
Our material cash requirements include contractual and other obligations which we previously disclosed within the financial statements and Management Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report. Other than the contractual obligation listed below, there have been no significant changes to these obligations in the three months ended MarchJune 31,30, 2026.
Purchase obligations are defined as agreements to purchase goods or services that are enforceable and legally binding and that specify all significant terms, including fixed or minimum quantities to be purchased, fixed, minimum, or variable pricing provisions and the approximate timing of the transactions. As of MarchJune 31,30, 2026, our total short-term obligations were $17.3$16.3 million.
BLFS insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 1 filing (1 insider, 3 trade dates, 1,200,000 shares, about $28.1M). Net open-market shares: -1,200,000 (purchases minus sales); net value about -$28.1M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-18 | Berard Todd |
Shares withheld for tax | 470 | $36.69 | $17.2K |
| 2026-09-18 | Mathew Aby J. |
Shares withheld for tax | 564 | $36.69 | $20.7K |
| 2026-09-18 | Werner Sean |
Shares withheld for tax | 421 | $36.69 | $15.4K |
| 2026-09-18 | De Greef Roderick |
Shares withheld for tax | 2,775 | $36.69 | $101.8K |
| 2026-09-18 | Wichterman Troy |
Shares withheld for tax | 937 | $36.69 | $34.4K |
| 2026-09-08 | Berard Todd |
Shares withheld for tax | 356 | $35.38 | $12.6K |
| 2026-09-08 | Mathew Aby J. |
Shares withheld for tax | 627 | $35.38 | $22.2K |
| 2026-09-08 | Wichterman Troy |
Shares withheld for tax | 1,026 | $35.38 | $36.3K |
| 2026-07-17 | Werner Sean |
Shares withheld for tax | 275 | $29.15 | $8.0K |
| 2026-07-07 | Wichterman Troy |
Shares withheld for tax | 844 | $27.79 | $23.5K |
| 2026-07-07 | Mathew Aby J. |
Shares withheld for tax | 516 | $27.79 | $14.3K |
| 2026-07-07 | Berard Todd |
Shares withheld for tax | 293 | $27.79 | $8.1K |
| 2026-06-18 | Berard Todd |
Shares withheld for tax | 470 | $26.04 | $12.2K |
| 2026-06-18 | Werner Sean |
Shares withheld for tax | 420 | $26.04 | $10.9K |
| 2026-06-18 | De Greef Roderick |
Shares withheld for tax | 2,775 | $26.04 | $72.3K |
| 2026-06-18 | Wichterman Troy |
Shares withheld for tax | 937 | $26.04 | $24.4K |
| 2026-06-18 | Mathew Aby J. |
Shares withheld for tax | 564 | $26.04 | $14.7K |
| 2026-06-08 | Wichterman Troy |
Shares withheld for tax | 1,026 | $26.10 | $26.8K |
| 2026-06-08 | Berard Todd |
Shares withheld for tax | 356 | $26.10 | $9.3K |
| 2026-06-08 | Mathew Aby J. |
Shares withheld for tax | 627 | $26.10 | $16.4K |
| 2026-05-21 | Casdin Partners Master Fund, L.p. |
Open-market sale | 650,000 | $23.70 | $15.4M |
| 2026-05-20 | Casdin Partners Master Fund, L.p. |
Open-market sale | 250,000 | $23.70 | $5.9M |
| 2026-05-19 | Casdin Partners Master Fund, L.p. |
Open-market sale | 300,000 | $22.65 | $6.8M |
Well-known investors holding BLFS (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 625,658 | $17.7M | 0.01% | New position |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 157,944 | $4.5M | 0.0% | Reduced 35% |
| Renaissance Technologies | 2026-06-30 | 207,128 | $4.0M | — | Sold out |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 35,019 | $988.9K | 0.0% | New position |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 15,739 | $444.5K | 0.0% | New position |
| D. E. Shaw & Co. | 2026-06-30 | 12,349 | $348.7K | 0.0% | Reduced 88% |