RGEN 10-K & 10-Q changes, risk factors and insider trading
Repligen Corp. · Nasdaq · Biological Products, (No Diagnostic Substances) · CIK 730272 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Our strategic investments, collaborations and joint ventures with and into business expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of such investments, collaborations and/or joint ventures with or into such businesses or technologies”
Largest changes
“At this time, we cannot predict the success of such efforts or the outcome of our assessment of the remediation efforts. We can give no assurance that our efforts will remediate these material weaknesses in our internal control over financial reporting, or that additional material weaknesses will not be identified in the future. …”see in full comparison
We will continue to monitor the design and operating effectiveness of these and other processes, procedures and controls and make any further changes management determines appropriate. While we are undertaking efforts to remediate these material weaknesses, the material weaknesses will not be considered remediated until our remediation plan has been fully implemented, the applicable controls operate for a sufficient period of time, andsee in full comparisonwemanagementhave concluded,concludes, through testing, thatthe newly implemented and enhancedthese controls are operating effectively.At this time, we cannot predict the success of such efforts or the outcome of our assessment of the remediation efforts.Wecanmaygivealsono assuranceconclude thatouradditionaleffortsmeasureswillare required to remediatethesethe material weaknesses in our internal control over financialreporting, or that additional material weaknesses will not be identified in the future. The effectiveness of our internal control over financial reporting is subject to various inherent limitations, including cost limitations, judgments used in decision making, assumptions about the likelihood of future events, the possibility of human error and the risk of fraud. If we are unable to remediate the material weaknesses, our ability to record, process and report financial information accurately, and to prepare the consolidated financial statements within the time periods specified by the rules and regulations of the SEC, could be adversely affected which, in turn, may adversely affect our reputation and business and the trading price of our common stock.reporting.
“In August 2022, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law. The IRA includes several provisions that will impact our business to varying degrees, including provisions that create a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new manufacturer financial liability on all drugs in Medicare Part D, allow the U.S. …”see in full comparison
“Inflation and rapid increases in interest rates have led to a decline in the trading value of previously issued government securities with interest rates below current market interest rates. Although the U.S. …”see in full comparison
“Our strategic investments, collaborations and joint ventures with and into business expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of such investments, collaborations and/or joint ventures with or into such businesses or technologies”see in full comparison
Wesee in full comparisonmayplan to build and integrate AI into our business practices, and the evolving nature of AI technologies and the surrounding legal and regulatory environment presents risks and uncertainties that could affect our business. The use of AI technology can give rise to intellectual property risks, includingcompromisesthetodisclosure or compromise of our confidential information or other proprietary intellectual property through the use of generative artificial intelligence tools. AI could also pose cybersecurity, data privacy, IT, regulatory, legal, operational, competitive, reputational, andintellectualotherpropertyrisksinfringement.and challenges that could affect our business. Specifically, risks related to bias, AI hallucinations, discrimination, harmful content, misinformation, fraud, scams, targeted attacks such as model poisoning or data poisoning, surveillance, data leakage, loss of consensus reality, inequality, environmental harms, and other harms may flow from our development, use, or deployment of AI technologies. Additionally, we expect to see increasing government regulation related to artificial intelligence use and ethics, which may also significantly increase the burden and cost of research, development and compliance in this area. For example, in the U.S., a number of states have proposedandor passed dozens of laws over the past year regulating various uses and applications ofAI,AI andfederalAIregulatorsgovernance,haveincludingissuedaddressingguidance affecting the usedeployment of AI inregulatedhealthcaresectors.settings. At the federal level, the Trump Administration has endorsed a federal moratorium on enforcement of certain state-level AI regulation, including through a December 11, 2025 Executive Order on “Ensuring a National Policy Framework for Artificial Intelligence.” So far, these efforts have not been successful at curtailing state action on AI regulation, contributing to a complicated legislative patchwork that may be litigated in state and federal courts. In Europe, the EU’s Artificial Intelligence Act (“AI Act”)—beganwhichitsentered into force onimplementation August 1, 2024and,withsomeaexceptions,largewillportionbeginscheduled toapplycome into effect in August 2026. As currently enacted, the AI Act, which may now be amended as part ofAugustthe2,EU’s2026Digital—Omnibus imposes significant obligations on providers and deployers of high-risk artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems. If we develop or deploy AI systems that are governed by these laws and regulations, we may be required toadoptimplement higher standards of data quality, transparency, and human oversight, and adhere to specific and potentially burdensome and costly ethical, accountability, and administrative requirements. Even in the absence ofdedicatededicated AI laws and regulations, we may be subject to novel legal and business risks relating to our adoption of these new technologies. Our vendors may in turn incorporate AI tools into their own offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security. Further, bad actors around the world use increasingly sophisticated methods, including the use of AI, to engage in illegal activities involving the unauthorized access, theft and misuse of personal information, confidential information, and intellectual property. Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.
Full comparison: every changed paragraph (94)
We compete with several medium and small companies in each of our product categories as well as several large companies, including Danaher Corporation (Pall Corporation and Cytiva), Thermo Fisher Scientific Inc., MilliporeSigma and Sartorius. Many of our competitors are large, well-capitalized companies that may have greater financial, manufacturing, marketing, research and development (“R&D”) resources than we have, as well as stronger name recognition, longer operating histories and benefits derived from greater economies of scale. As a consequence, they are able to spend more aggressively on product development, marketing, sales and other product initiatives than we can, and may have additional lines of products and the ability to bundle products.
TheAlthough we do not currently have any customers that represent more than 10% of our consolidated revenues, the loss of, or a significant reduction in orders from, any of our large customers, including following any termination or failure to renew a long-term supply contract, would significantly reduce our revenues and harm our results of operations. If a large customer purchases fewer of our products, defers orders or fails to place additional orders with us for any reason, including for business continuity purposes, our revenue could decline, and our operating results may not meet market expectations.
Risks Related to Product DevelopmentDevelopment, Strategic Investments, Collaborations and Acquisitions
As a part of our growth strategy, we may make selected acquisitions of complementary products and/or businesses, such as our most recent acquisitions of Tanttithe 908 Devices Inc. PAT Portfolio,Tantti Laboratory Inc., Metenova Holding AB and FlexBiosys, Inc. Any acquisition involves numerous risks and operational, financial, and managerial challenges, including the following, any of which could adversely affect our business, financial condition, or results of operations:
Our strategic investments, collaborations and joint ventures with and into business expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of such investments, collaborations and/or joint ventures with or into such businesses or technologies
As part of our growth strategy, we may enter into strategic investments, collaborations, joint ventures, and similar arrangements to expand our capabilities, access new technologies and enter new markets. These transactions involve significant risks and uncertainties that could adversely affect our business, financial condition, or results of operations, including:
Limited Control and Alignment Challenges: In joint ventures or minority investments, we may have limited ability to influence strategic decisions or operational practices. Differences in objectives, governance structures, or priorities with partners can lead to conflicts and inefficiencies.
Financial Exposure: Investments and collaborations may underperform or fail, resulting in impairment charges or loss of invested capital. Returns may be delayed, uncertain, or significantly below expectations.
Dependence on Third Parties: Our success often depends on the performance and cooperation of partners for development, commercialization, or distribution activities. Delays, quality issues, or regulatory non-compliance by partners could negatively impact our operations.
Intellectual Property Risks: Disputes over ownership or use of intellectual property, limitations on our ability to protect or enforce rights, and potential loss of proprietary technology through licensing arrangements.
Operational and Compliance Risks: Challenges in monitoring and managing joint venture activities, exposure to unfamiliar legal, tax, and regulatory frameworks—particularly in foreign jurisdictions—and potential liability for actions taken by partners or affiliates.
Liquidity and Exit Risks: Minority investments may be illiquid, and we may be unable to sell or exit these investments on favorable terms or within desired timeframes.
Reputational Risks: Actions or failures by partners or investee companies could negatively impact our reputation or business relationships.
Termination or Non-Performance: Collaborations or joint ventures may be terminated early or fail to deliver anticipated benefits, leaving us without expected products, technologies, or revenue streams.
There can be no assurance that any strategic investment, collaboration, or joint venture will achieve its intended objectives or generate anticipated benefits within a reasonable timeframe, or at all. Failure to successfully manage these risks could materially and adversely affect our business and growth prospects.
OurAny future corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.
In July 2023, ourwe Board of Directors (“Board”) authorized the Company's management team to undertakeundertook restructuring activities to simplify and streamline our organization and strengthen the overall effectiveness of ouroperations. operationsWe (themay “Restructuringneed Plan”).to Asundertake partanother oforganizational restructuring in the Restructuring Plan, we consolidated a portion of our manufacturing business between certain U.S. locations and reduced our headcount.future. We may not realize, in full or in part, the anticipated benefits, savings and improvements in our cost structure from ourany future restructuring efforts due to unforeseen difficulties, delays or unexpected costs. If we are unable to realize the expected operational efficiencies and cost savings from thea Restructuring Plan,restructuring, our operating results and financial condition couldwould be adversely affected. Furthermore, theour Restructuringrestructuring Planplan may be disruptive to our operations. FurtherFor restructuringexample, andany cost-cuttingfuture activitiesheadcount may be required andreductions could yield unintendedunanticipated consequences and costs,consequences, such as aincreased reductiondifficulties in morale among our remaining employees, adverse effects to our reputation as both an employer and with respect to customers, the loss of institutional knowledge and expertise, and increased likelihood of turnover of key members of management and employees, all of which can impede our ability to successfully implementimplementing our business strategy, andincluding consequently,retention of our business,remaining financialemployees. condition,A andfuture resultsrestructuring ofmay operationslead to employee litigation related to the headcount reduction, which could be materiallycostly and adverselyprevent affected.management from fully concentrating on the business.
WeOur conductinternational asales largeare portionoften of our businessdenominated in internationalforeign markets.currencies. For the fiscal year ended December 31, 2024,2025, 37.0%39.5% of our revenues were denominated in foreign currencies with the primary foreign currency exposures being the SwedishEuro, krona,South EuroKorean Won and ChineseJapanese yuan.Yen. We are exposed to the risk of an increase or decrease in the value of the foreign currencies relative to the U.S. dollar, which could decrease the value of our revenue and increase the value of our expenses and costs when measured in U.S. dollars. These fluctuations could also adversely affect the demand for products and services provided by us. As a result, our results of operationoperations may be influenced by the effects of future exchange rate fluctuations and such effects may have an adverse impact on our common stock price.
Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (“FDIC”) as receiver. Similarly, on March 12, 2023, Signature Bank and Silvergate Capital Corp. were each swept into receivership. If any of our lenders or counterparties to any such instruments were to be placed into receivership, we may be unable to access such funds. We have a banking relationship with SVB and hold cash, cash equivalents and marketable securities of $0.3 million as of December 31, 2024 in SVB depository accounts to cover short-term operational payments. While we have not experienced any losses in such accounts, the recent failure of SVB caused us to utilize our accounts at other financial institutions in order to mitigate potential operational risks stemming from the temporary inability to access funds in our SVB operating accounts. In addition, if any of our customers, suppliers or other parties with whom we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution, such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments to us could be adversely affected.
Inflation and rapid increases in interest rates have led to a decline in the trading value of previously issued government securities with interest rates below current market interest rates. Although the U.S. Department of Treasury, FDIC and Federal Reserve Board have announced a program to provide up to $25 billion of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial institutions for immediately liquidity may exceed the capacity of such program. Additionally, there is no guarantee that the U.S. Department of Treasury, FDIC and Federal Reserve Board will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion.
In addition, any further deterioration in the global economy or financial services industry, including butany not limited to the changechanges in the U.S. presidential administration,administration policies, or increased U.S. trade tariffs and trade disputes with other countries could lead to losses or defaults by our suppliers, which in turn,turn could have a material adverse effect on our current and/or projected business operations and results of operations and financial condition. For example, increased tariffs on essential materials could raise production costs and reduce profitability if we are unable to pass these costs on to customers. Additionally, retaliatory trade measures by other countries could limit our access to key international markets, restricting revenue growth. Any delays or disruptions in our supply chain due to geopolitical tensions, regulatory changes, or trade disputes could adversely affect our ability to manufacture and deliver products, potentially impacting our financial performance and customer relationships.
To mitigate these risks, we have implemented strategies to reduce tariff exposure and closely monitor trade policy developments. However, recent litigation challenging the legality of certain tariffs before the U.S. Supreme Court introduces additional uncertainty. If such tariffs are deemed unlawful, resulting policy reversals or retaliatory measures could create new risks and volatility in global trade, which may adversely affect our operations and financial results.
The market price of our common stock, like that of the common stock of many other companies with similar market capitalizations, is highly volatile. The stock market in general, and the market for life sciences, biotechnology and pharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of specific companies, the conflict in Ukraine and Israel, and rising inflation and changing interest rates in the United States, which have resulted in decreased stock prices for many companies notwithstanding the lack of a fundamental change in their underlying business models or prospects. Broad market and industry factors, including potentially worsening economic conditions, may adversely affect the market price of our common stock, regardless of our actual operating performance.
Effective internal controls are 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 internal controls, 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, including objectives that may involve our reliance on third-party advisors and professionals As discussed below in Part II, Item 9A, “Controls and Procedures,” of this report, we have identified material weaknesses in our internal control over financial reporting related to (i) controls related to revenue recognition specific to the evaluation of accounting for contract terms, (ii) information technology (“IT”) general controls for information systems that are relevant to the preparation of our financial statements, and (iii) business process-level controls related to inventory valuation and the financial statement close process either in a timely manner or with an appropriate precision threshold. As a result of these material weaknesses, our management concluded that our internal control over financial reporting was not effective as of December 31, 2024.professionals.
As previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, the Company identified the following material weaknesses in internal control over financial reporting:
1.
Management identified deficiencies related to the design and operating effectiveness of controls related to revenue recognition specific to the evaluation of accounting for contract terms (as originally reported in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2023).
2.
Management did not maintain effective information technology (“IT”) general controls for information systems that are relevant to the preparation of our financial statements. Specifically, we did not maintain logical access controls and program change management controls to ensure that access to programs and data are appropriately restricted and program and data changes are identified, tested, authorized and implemented appropriately. As a result, automated and business process controls that rely on information from the systems were also deemed ineffective because they could have been adversely affected.
3.
Irrespective of the effects of the IT general controls deficiencies, management did not perform certain business process-level controls related to inventory valuation and the financial statement close process either in a timely manner or with an appropriate precision threshold.
As discussed below in Part II, Item 9A, “Controls and Procedures,” in this Annual Report on Form 10-K, the material weakness related to revenue recognition has been remediated and no longer exists as of December 31, 2025. However, the material weaknesses associated with IT general controls and business process controls related to inventory valuation and the financial statement close process were not remediated as of December 31, 2025. Based on these unremediated material weaknesses, the Company’s management concluded that at December 31, 2025, the Company’s internal control over financial reporting was not effective.
We continue to implement measures designed to remediate the identified material weaknesses. The measures include (i) incorporating the use of automated workflows to manage the granting and monitoring of access within IT systems relevant to the preparation of our financial statements, (ii) redesigning existing controls with additional attribute the presume IT risk relevant to the control, (iii) reassessing the operating effectiveness of our business process-level controls related to inventory valuation and financial statement close process and (iv) assessing the frequency of our control monitoring activities to ensure that they are conducted in a timely manner.
Following identification of these material weaknesses, and as part of our commitment to strengthen our internal control over financial reporting, we are implementing remedial actions under the oversight of the Audit Committee of our Board to address these deficiencies. Our remediation activities will include the following:
Our remediation activities include the following with respect to revenue recognition:
Designing and implementing new internal controls to validate there is a complete listing of revenue contracts that have non-standard terms, which require incremental accounting analysis under ASC 606.
Designing and implementing new internal controls evaluating the accounting for contract amendments, including amendments accounted for as contract modifications.
Enhancing and expanding our existing revenue recognition control procedures and attributes when evaluating the accounting impact of non-standard contract terms and contract modifications.
Increased education for internal resources on accounting for contracts within the scope of ASC 606 and deploying enablers to facilitate documentation of accounting analyses and conclusions.
Our remediation activities will include the following with respect to IT general controls:
Reassessing the operating effectiveness of internal controls related to the program and data change management and user access processes; and Expanding the management and governance over IT system controls.
Our remediation activities will include the following with respect to certain business process-level controls:
Reassessing the operating effectiveness of these controls, including precision thresholds, timely execution, and documentation requirements for control owners;
Assessing the frequency of our control monitoring activities to ensure that they are conducted in a timely manner; and Hiring additional staff, including external experts, to enhance the performance, documentation, and monitoring of such controls. This includes providing training for control owners setting out expectations as it relates to the control risk and design, execution and monitoring of such controls, including enhancements to the documentation to evidence the execution of the control.
We will continue to monitor the design and operating effectiveness of these and other processes, procedures and controls and make any further changes management determines appropriate. While we are undertaking efforts to remediate these material weaknesses, the material weaknesses will not be considered remediated until our remediation plan has been fully implemented, the applicable controls operate for a sufficient period of time, and wemanagement have concluded,concludes, through testing, that the newly implemented and enhancedthese controls are operating effectively. At this time, we cannot predict the success of such efforts or the outcome of our assessment of the remediation efforts. We canmay givealso no assuranceconclude that ouradditional effortsmeasures willare required to remediate thesethe material weaknesses in our internal control over financial reporting, or that additional material weaknesses will not be identified in the future. The effectiveness of our internal control over financial reporting is subject to various inherent limitations, including cost limitations, judgments used in decision making, assumptions about the likelihood of future events, the possibility of human error and the risk of fraud. If we are unable to remediate the material weaknesses, our ability to record, process and report financial information accurately, and to prepare the consolidated financial statements within the time periods specified by the rules and regulations of the SEC, could be adversely affected which, in turn, may adversely affect our reputation and business and the trading price of our common stock.reporting.
At this time, we cannot predict the success of such efforts or the outcome of our assessment of the remediation efforts. We can give no assurance that our efforts will remediate these material weaknesses in our internal control over financial reporting, or that additional material weaknesses will not be identified in the future. The effectiveness of our internal control over financial reporting is subject to various inherent limitations, including cost limitations, judgments used in decision making, assumptions about the likelihood of future events, the possibility of human error and the risk of fraud. If we are unable to remediate the material weaknesses, our ability to record, process and report financial information accurately, and to prepare the consolidated financial statements within the time periods specified by the rules and regulations of the SEC, could be adversely affected which, in turn, may adversely affect our reputation and business and the trading price of our common stock.
The enactment of legislation implementing changes in taxation of international business activities, the adoption of other corporate tax reform policies, or changes in tax legislation or policies, or interpretations thereof, could materially impact our financial position and results of operations. For example, the enactment of the One Big Beautiful Bill Act (the “OBBBA”) in the United States introduced significant changes to corporate and international tax rules, including adjustments to deductions, expensing provisions, and foreign income calculations. These changes may affect our effective tax rate and require modifications to our tax planning strategies.
Corporate tax reform, base-erosion efforts and tax transparency continue to be high priorities in many tax jurisdictions where we have business operations. As a result, policies regarding corporate income and other taxes in numerous jurisdictions are under heightened scrutinyscrutiny, and tax reform legislation is being proposed or enacted in a number of jurisdictions. There is no assurance that our actual income tax liability will not be materially different than what is reflected in our income tax (provision or benefit) provisions and accruals as a result of changes in tax laws.
Due to the large scale of our international business activities, any substantial changes in international corporate tax policies, enforcement activities or legislative initiatives—such as those introduced under the OBBBA—may materially adversely affect our business, the amount of taxes we are required to pay and our financial condition and results of operations generally.
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 percentage points of its stock over a three-year period, to utilize its net operating loss and tax credit carryforwards and certain built-in losses recognized in years after the ownership change. 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 the company. Generally, if an ownership change occurs, the yearly taxable income limitation on the use of net operating loss and tax credit carryforwards and certain built-in losses is equal to the product of the applicable long-term, tax-exempt rate and the value of the company’s 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. Federal net operating losses generated after December 31, 2017, are not subject to expiration and generally may not be carried back to prior taxable years except that, under the Coronavirus Aid, Relief, and Economic Security Act, net operating losses generated in 2018, 2019 and 2020 may be carried back five taxable years. Additionally, for taxable years beginning after December 31, 2020, the deductibility of such deferraldeferred net operating losses is limited to 80% of our taxable income in any future taxable year.
We are subject to U.S. export controls and sanctions regulations that restrict the shipment or provision of certain products and services to certain countries, governments, and persons.persons, including those administered by the Bureau of Industry and Security (“BIS”). While we take precautions to prevent our products and services from being exported in violation of these laws, we cannot guarantee that the precautions we take will prevent violations of export control and sanctions laws. We believe that, in the past, we and our subsidiaries may have exported certain products without a required export license in apparent violation of U.S. export control laws. As a result, we have submitted to the U.S. Department of Commerce’s Bureau of Industry and Security various notices of voluntary self-disclosure concerning potential violations. If we are found to be in violation of U.S. sanctions or export control laws, it could result in substantial fines and penalties for us and for the individuals working for us. We may also be adversely affected through other penalties, reputational harm, loss of access to certain markets, or otherwise.
Complying with export control and sanction regulations may be time-consuming and may result in the delay or loss of sales opportunities or impose other costs. Any change in export or import regulations, economic sanctions or related legislation, or change in the countries, governments, persons or technologies targeted by such regulations, could result in our decreased ability to export or sell certain products to existing or potential customers in affected jurisdictions. Additionally, geopolitical tensions and heightened regulatory scrutiny could lead to delays in obtaining BIS licenses, which may postpone exports and disrupt our ability to meet customer demand.
Investor advocacy groups, institutional investors, investment funds, market participants, and other stakeholders have increasingly focused on sustainability or Environmental, Social, and Governance (“ESG”) practices, including those related to climate change. The European Union has emerged as a key driver of ESG regulation through initiatives such as the Corporate Sustainability Reporting Directive and Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020, which imposed detailed disclosure and compliance requirements on companies operating in or doing business with the European Union (“EU”). These frameworks aim to standardize sustainability reporting and align corporate activities with climate and social objectives, increasing scrutiny on companies’ ESG performance.
Investor advocacy groups, certain institutional investors, investment funds, other market participants and other stakeholders have focused increasingly on the Environmental, Social and Governance (“ESG”) practices of companies, including those associated with climate change. These parties have placed increased importance on the importance on the implications of the social cost of their investments. If our ESG practices do not meet investorevolving investor, regulatory, or other industry stakeholderexpectations, expectationsour reputation, investor confidence, and standards, which continue to evolve, our reputation and associateemployee retention may be negatively impacted based on an assessment of our ESG practices.impacted. Any sustainability disclosures we make may include our policies and practices on a variety of social and ethical matters, including corporate governance, environmental compliance, employee health and safety practices,safety, human capital management, product quality, supply chain management, and workforce inclusion. It is possible that stakeholdersStakeholders may not be satisfied with our ESG practices or the speedpace of their adoption, or that we may notfail sufficientlyto communicate ourthem effectively. Compliance with emerging ESG practicesregulations, sufficientlyincluding tothe stakeholders.EU Werequirements, could alsoresult incurin additional costs and requireresource additionalcommitments resourcesfor tomonitoring, monitor, report,reporting, and complyassurance. with various ESG practices. In addition, investorsInvestors may decide toalso refrain from investing in us asbased a result ofon their assessment of our approach to and consideration of the ESG factors.approach.
In addition, we face physical risks associated with climate change.change, These physical risks include risks to our manufacturing and supply chain fromincluding flooding, severe storms, wildfires, droughtsdroughts, orand extreme temperatures, all of which could disrupt manufacturing and supply chains, increase costscosts, and impair our ability to meet customer demands in a timely manner.demand. To date, we have not experienced material losses or operational disruptions to our operations related to climate change,change and we do not anticipate that these risks will have a material impact to our Company in the near term. However, future events could materially impact our business.
Health care reform measures could adversely affect our business. Efforts by governmental and third-party payors to contain or reduce health care costs may negatively impact pharmaceutical and biotechnology companies, including ours. Legislative and regulatory proposals in the United States and abroad continue to seek changes to health care systems that could affect our ability to sell products profitably.
The Patient Protection and Affordable Care Act (the “ACA”), as amended, substantially changed how health care is financed by governmental and private insurers. More recently, the OBBBA enacted in July 2025 includes provisions that significantly reduce federal health care spending, impose new Medicaid eligibility restrictions, and introduce work requirements. These measures are expected to reduce coverage for millions of individuals and may alter reimbursement dynamics for drugs and biologics. Such changes could limit pricing flexibility and reduce demand for certain therapies.
The Trump administration has prioritized cost containment and deregulation, including proposals to expand price transparency, encourage importation of lower-cost drugs, and promote competitive bidding for Medicare and Medicaid programs. In addition, litigation and legislative efforts to repeal or modify provisions of the Inflation Reduction Act of 2022 (the “IRA”), including Medicare drug price negotiation authority, remain ongoing. Future actions could accelerate these changes or introduce new pricing controls.
Federal and state governments continue to pursue measures such as price caps, rebate requirements, and restrictions on marketing practices. Regional health authorities and hospitals increasingly use competitive bidding to select suppliers, which may further pressure pricing and reduce demand for our products. Additional reforms at the federal or state level are likely and could materially and adversely affect our business, financial condition, results of operations, and prospects.
The efforts of governmental and third-party payors to contain or reduce the costs of health care 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 health care system in ways that could affect our ability to sell our products profitably. For the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (together, the “ACA”), substantially changed the way health care is financed by both governmental and private insurers. The ACA and other federal and state proposals and health care reforms could limit the prices that can be charged for the products we develop and may limit our commercial opportunity.
Management's Discussion & Analysis (MD&A)
New heading “2025 Acquisition”
New heading “Acquisition of 908 Devices PAT Portfolio”
New heading “Contractual Obligations”
Removed heading “Intangible assets and goodwill”
Removed heading “Debt accounting”
Removed heading “Stock-based compensation”
Removed heading “Royalty revenues”
Removed heading “Effect of exchange rate changes on cash, cash equivalents and restricted cash”
Largest changes
“A change in the estimated timing or amount of demand for our products could result in additional provisions for excess inventory quantities on hand. Any significant unanticipated changes in demand or unexpected quality failures could have a significant impact on the value of inventory and reported operating results. …”see in full comparison
“We test goodwill for impairment on an annual basis and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying value. Events that would indicate impairment and trigger an interim impairment assessment include, but are not limited to, macroeconomic conditions, industry and market conditions, entity specific factors such as strategies and financial performance, a significant adverse change in legal factors and an adverse action or assessment by a regulator. …”see in full comparison
“Prior to fiscal year 2024, testing of impairment on our goodwill occurred annually as of our measurement date of December 31st, pursuant to Company policy. Subsequent to the 2023 annual impairment test, which was completed on December 31, 2023, we voluntarily changed our annual impairment assessment date from December 31st to October 1st, the first day of our fourth quarter, beginning on October 1, 2024. The change is being made to better align the annual impairment assessment date with our annual planning and budgeting process as well as the long-term planning and forecasting process. …”see in full comparison
see in full comparisonGrossInmargin2025,wascost43.3%ofingoods2024,sold decreased $7.8 million, or 2.2%, compared to44.0%2024. The decrease in2023.costTheofreductiongoodsin gross margin in 2024 as compared to 2023,sold is primarily due to lower costs related to scrap, excess and obsolete inventory and restructuring activitiesasinnoted2025,abovecomparedduringto2024those incurred in 2024. Restructuring relates to activities to simplify and streamline our organization and strengthen the overall effectiveness of ouroperations,operations.whichThese decreases were$13.6partiallymillionoffset by higherinexport2024duties,thandirect2023.materialPartiallyandoffsettinglaborthis increase in costs, margins increased as a result of a change in product mix.costs.
We have experienced, and expect to continue to experience, cost inflation, primarily in rawsee in full comparisonmaterials,materials and other supply chain costs, as a result of global macroeconomic trends, including global geopolitical conflicts and labor shortages. Actions taken to mitigate supply chain disruptions and inflation, including price increases and productivity improvements, have generally been successful in offsetting the impact of these trends.In addition, decreasing demand for vaccines for the COVID-19 pandemic, including all subsequent variants of the SARS-CoV-1 coronavirus (“COVID-19”) is driving a reduction in future demand of our products related to these vaccines.Weexpect that these trends willcontinue toimpactmonitorourtheresultseffectsforof2025tariffsasimplementedwell.by the Trump administration and the potential imposition of modified or additional tariffs.
Full comparison: every changed paragraph (100)
Information pertaining to fiscal years 20232024 and 20222023 was included in the Company’s Annual Report on Form 10-K/A (“Form 10-K/A”) for the year ended December 31, 2023,2024, on pages 3639 through 5052 under Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” which was filed with the Securities and Exchange CommissionSEC on NovemberMarch 18,14, 2024 and Form 10-K for the year ended December 31, 2022, on pages 37 through 53 under Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” which was filed with the Securities and Exchange Commission on February 22, 2023, respectively.2025.
Repligen and its subsidiaries, collectively doing business as Repligen Corporation (“Repligen”, “we”, “our”, or “the Company”) is a global life sciences company that develops and commercializes highly innovated bioprocessing technologytechnologies and systems that increase efficiencies and flexibility in the process of manufacturing biological drugs.
As the overall market for biologics continues to grow and expand, our customers – primarily large biopharmaceutical companies and contract development and manufacturing organizations (“CDMOs”) and other life sciences companies (integrators) – face critical production cost, capacity, quality and time pressures. BuiltOur products help enable customers to address these concerns, ourboth productsaccelerating helpdevelopment setand newimproving standards for the way biologics are manufactured.yields. We are committed to inspiring advances in bioprocessing as a trusted partner in the production of critical biologic drugs – including monoclonal antibodies (“mAbs”), and mAb derivatives like antibody drug conjugates, recombinant proteins, RNA-based therapeutics and vaccines and cell and gene therapies (“C>”) – that are improving human health worldwide. Increasingly, our technologies are being implemented to overcome challenges in processing plasmid DNA (a starting material for the production of mRNA) and gene delivery vectors such as lentivirus and adeno-associated viral vectors. For more information regarding our business, products and acquisitions, see above sections in Part I, Item 1. "Business" including “Overview”, “Ourincluded Products”,in “2024this Acquisitions”,Annual “2023Report Acquisitions”on andForm “Our Market Opportunity” sections therein.10-K.
As a result of our global presence, a significant portion of our revenue and expenses is denominated in currencies other than the United States (“U.S.”) dollar. We are therefore subject to non-U.S. exchange exposure. Exchange rates can be volatile and a substantial weakening or strengthening of foreign currencies against the U.S. dollar could increase or reduce our revenue and gross profit margin and impact the comparability of results from period to period.
We have experienced, and expect to continue to experience, cost inflation, primarily in raw materials,materials and other supply chain costs, as a result of global macroeconomic trends, including global geopolitical conflicts and labor shortages. Actions taken to mitigate supply chain disruptions and inflation, including price increases and productivity improvements, have generally been successful in offsetting the impact of these trends. In addition, decreasing demand for vaccines for the COVID-19 pandemic, including all subsequent variants of the SARS-CoV-1 coronavirus (“COVID-19”) is driving a reduction in future demand of our products related to these vaccines. We expect that these trends will continue to impactmonitor ourthe resultseffects forof 2025tariffs asimplemented well.by the Trump administration and the potential imposition of modified or additional tariffs.
2025 Acquisition
Acquisition of 908 Devices PAT Portfolio
On March 4, 2025, the Company completed its acquisition of 908 Devices Inc.’s (“908 Devices”) desktop portfolio of four devices for bioprocessing process analytical technology applications (“PAT Portfolio”). In connection with the transaction, Repligen also acquired facilities, employees, equipment and lease obligations for facilities in North Carolina and Braunschweig, Germany as well as certain working capital balances related to the PAT Portfolio. This transaction is referred to as the 908 Devices PAT Portfolio acquisition.
The addition of these desktop assets complements and strengthens Repligen’s differentiated PAT Portfolio that provides its biopharmaceutical and CDMO customers with actionable insights to optimize development processes and improve manufacturing efficiencies.
The preparation of our financial statements and related disclosures require us to make estimates, assumptions and judgments. We believe the accounting policies described below, some of which require estimates, assumptions and judgments, have the greatest potential impact on our financial statements and related disclosures. Therefore we consider these to be our critical accounting policies. Although we believe that our estimates, assumptions, and judgments are reasonable, they are based upon information presently available. Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions. See Note 2, “Summary of Significant Accounting Policies” in the notes to the consolidated financial statements, included within Part IV, Item 15, “Exhibits and Financial Statement Schedules”, in this Annual Report on Form 10-K.
While our significant accounting policies are more fully described in the notes to our consolidated financial statements, 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 judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. The impact of and any associated risks related to these policies on our business operations are discussed throughout “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” specifically in the “Results of Operations” section, where such policies affect our reported and expected financial results. Although we believe that our estimates, assumptions, and judgments are reasonable, they are based upon information presently available. Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions.
We generate revenue from the sale of bioprocessing products, equipment devices, and related consumables used with these equipment devices to customers in the life science and biopharmaceutical industries. Under Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers,” revenue is recognized when, or as, obligations under the terms of a contract are satisfied, which occurs when control of the promised products or services is transferred to customers. Revenue is measured as the amount of consideration we expect to receive in exchange for transferring those products or services to a customercustomers (“transaction price”). To the extent the transaction price includes variable consideration, such as sales rebates, we estimate 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. Variable consideration is included in the transaction price if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration and the determination of whether to include estimated amounts in the transaction price are based largely on an assessment of our anticipated performance and all information (historical, current and forecasted) that is reasonably available. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
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. We do not assess whether a significant financing component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less. None of our contracts contained a significant financing component as of December 31, 2024.
Contracts with customers may contain multiple performance obligations. For such arrangements, the transaction price is allocated to each performance obligation based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. We determine standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, we estimate the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations.
We recognize product revenue under the terms of each customer agreement upon transfer of control to the customer, which occurs at a point in time.
Shipping and handling fees are recorded as a component of product revenue, with the associated costs recorded as a component of cost of goods sold in our consolidated statements of comprehensive income.
We value inventory at cost or, if lower, net realizable value, using the first-in, first-out method. We review our inventory at least quarterly and record a provision for excess and obsolete inventory based primarily on historical consumption patterns, our estimates of expected future sales volume, production capacityvolume and expiration dates of raw materials, work-in-process and finished products. We write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value, and inventory in excess of expected requirements to cost of goods sold in our consolidated statements of comprehensive income.income or loss. Manufacturing of bioprocessing finished goods is done to order and tested for quality specifications prior to shipment.
A change in the estimated timing or amount of demand for our products could result in additional provisions for excess inventory quantities on hand. In addition, significant unanticipated changes in demand or unexpected quality failures could have a significant impact on the value of inventory and reported operating results.
A change in the estimated timing or amount of demand for our products could result in additional provisions for excess inventory quantities on hand. Any significant unanticipated changes in demand or unexpected quality failures could have a significant impact on the value of inventory and reported operating results. In 2024, we recorded $36.0 million in inventory adjustments, which includes the impact of the Company discontinuing the sale of certain product SKUs and the impact of having proactively secured materials during the pandemic to meet accelerated demand during a challenging supply chain environment in the industry. Where demand has reduced, finished goods and raw materials, whose value exceeded the projected requirements to be used before reaching their expiration date, or in a reasonable time horizon, were written down to their realizable value. The Restructuring Plan described in Note 7, “Restructuring Activities and Other Inventory-Related Charges,” to our consolidated financial statements, also includes the closing of manufacturing facilities and excess production lines, which included inventory that could not be repurposed.
Total consideration transferred for acquisitions is allocated to the tangible and intangible assets acquired and liabilities assumed, if any, based on their fair values at the dates of acquisition. This purchase price allocation process requires management to make significant estimates and assumptions with respect to intangible assets and deferred revenue obligations.assets. The fair value of identifiable intangible assets is based on detailed valuations that use information and assumptions determined by management. Any excess of purchase price over the fair value of the net tangible and intangible assets acquired is allocated to goodwill. While we use our best estimates and assumptions to accurately value assets acquired and liabilities assumed at the acquisition date as well as any contingent consideration, where applicable, our estimates are inherently uncertain and subject to refinement. As a result, during the measurement period, which may be up to one year from the acquisition date, we record adjustments to the assets acquired and liabilities assumed with the corresponding offset to goodwill. Upon conclusion of the measurement period or final determination of the values of assets acquired or liabilities assumed, whichever comes first, any subsequent adjustments are recorded to our consolidated statements of comprehensive income.income Theor Company estimates the fair value of the contingent consideration earnouts using a Monte Carlo Simulation and updates the fair value of the contingent consideration at each reporting period based on the estimated probability of achieving the earnout targets and applying a discount rate that captures the risk associated with the expected contingent payments. To the extent that our estimates change in the future regarding the likelihood of achieving these targets, we may need to record material adjustments to our accrued contingent consideration. Such changes in the fair value of contingent consideration are recorded as contingent consideration in our consolidated statements of comprehensive income. The fair value of contingent consideration obligations for the year ended December 31, 2024 had a net change of $3.2 million primarily related to the change in the contingent consideration obligations from the acquisition of Avitide, Inc. (“Avitide”) in September 2021.loss.
Fair value of contingent consideration includes estimates and judgments made by management regarding the probability that future contingent payments will be made and the extent of payments to be earned in excess of defined minimum sales thresholds and achievement of defined milestones. To the extent that our estimates change in the future regarding the likelihood of achieving these targets, we may need to record material adjustments to our accrued contingent consideration. Such changes in the fair value of contingent consideration are recorded as contingent consideration in our consolidated statements of comprehensive income or loss.
We use the income approach to determine the fair value of certain identifiable intangible assets including customer relationships and developed technology. This approach determines fair value by estimating after-tax cash flows attributable to these assets over their respective useful lives and then discounting these after-tax cash flows back to a present value. WeThe baseCompany ourbases its assumptions on estimates of future cash flows, expected growth rates, expected trends in technology, etc. We base the discountDiscount rates used to arrive at a present value as of the date of acquisition are based on the time value of money and certain industry-specific risk factors. WeThe believeCompany believes the estimated purchased customer relationships, developed technologies, trademark/tradename, patents, non-competition agreementstradename and in-processother researchintangible andassets developmentidentified ("R&D")in amountsits so determinedacquisitions represent the fair value at the date of acquisitionacquisition, and do not exceed the amount a third-party would pay for thesuch assets.
Intangible assets and goodwill
Intangible assets with a definite life are amortized over their useful lives using the straight-line method and the amortization expense is recorded within cost of goods sold, research and development, and selling, general and administrative expense in the consolidated statements of comprehensive income.income or loss. Intangible assets and their related useful lives are reviewed at least annually to determine if any adverse conditions exist, that would indicate the carrying value of these assets may not be recoverable. More frequent impairment assessments are conducted if certain conditions exist, including a change in the competitive landscape, any internal decisions to pursue new or different technology strategies, a loss of a significant customer, or a significant change in the marketplace, including changes in the prices paid for the Company’s products or changes in the size of the market for the Company’s products. If impairment indicators are present, the Company determines whether the underlying intangible asset is recoverable through estimated future undiscounted cash flows. If the asset is not found to be recoverable, it is written down to the estimated fair value of the asset based on the sum of the future discounted cash flows expected to result from the use and disposition of the asset. If the estimate of an intangible asset’s remaining useful life is changed, the remaining carrying amount of the intangible asset is amortized prospectively over the revised remaining useful life. The Company continues to believe that its definite-lived intangible assets are recoverable at December 31, 2024.2025.
We test goodwill for impairment on an annual basis and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying value. Events that would indicate impairment and trigger an interim impairment assessment include, but are not limited to, macroeconomic conditions, industry and market conditions, entity specific factors such as strategies and financial performance, a significant adverse change in legal factors and an adverse action or assessment by a regulator. Goodwill is tested for impairment as of October 1 of each year, or more frequently as warranted by events or changes in circumstances mentioned above. Accounting guidance also permits an optional qualitative assessment for goodwill to determine whether it is more likely than not that the carrying value of a reporting unit exceeds its fair value. If, after this qualitative assessment, we determine that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then no further quantitative testing would be necessary. A quantitative assessment is performed if the qualitative assessment results in a more likely than not determination or if a qualitative assessment is not performed. The quantitative assessment considers whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recorded to the extent the reporting unit’s carrying value exceeds its fair value.
We operate as one reporting unit. We performed a qualitative assessment for our reporting unit as of October 1, 2024, December 31, 2023 and December 31, 2022. Based on the assessment, we concluded that it was more likely than not that the estimated fair value of our reporting unit for 2024, 2023 and 2022 was higher than its carrying value for such years, and that the performance of the quantitative impairment test was not required. Therefore, no impairment was required for any of the periods presented.
Prior to fiscal year 2024, testing of impairment on our goodwill occurred annually as of our measurement date of December 31st, pursuant to Company policy. Subsequent to the 2023 annual impairment test, which was completed on December 31, 2023, we voluntarily changed our annual impairment assessment date from December 31st to October 1st, the first day of our fourth quarter, beginning on October 1, 2024. The change is being made to better align the annual impairment assessment date with our annual planning and budgeting process as well as the long-term planning and forecasting process. We have determined that this voluntary change in accounting principle is preferable and will not impact our consolidated financial statements nor is it being done to accelerate, avoid or trigger an impairment charge. This change is not going to be applied retrospectively as it is impracticable to do so because retrospective application would require application of significant estimates and assumptions with the use of hindsight. Therefore, the change will be applied prospectively.
Debt accounting
In December 2023, we issued $600.0 million aggregate principal amount of 1.00% Convertible Senior Notes due 2028 (“2023 Notes”) in a private placement pursuant to separate, privately negotiated exchange and subscription agreements (the “Exchange and Subscription Agreements”) with a limited number of holders of our outstanding 0.375% Convertible Senior Notes due 2024 (“2019 Notes”) and certain other qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Pursuant to the Exchange and Subscription Agreements, we exchanged $217.7 million of our 2019 Notes for $309.9 million aggregate principal amount of the 2023 Notes (the “Exchange Transaction”) and issued $290.1 million aggregate principal amount of the 2023 Notes in a private placement to accredited institutional buyers (the “Subscription Transactions”) for cash. Immediately following the closing of the aforementioned transactions, $69.7 million in aggregate principal amount of the 2019 Notes remained outstanding.
We evaluated the Exchange Transaction and determined approximately $29.6 million of the $217.7 million principal of the exchanged 2019 Notes were accounted for as extinguishments of debt and approximately $188.1 million were accounted for as modification of debt. As a result, we recognized a $12.7 million loss on extinguishment of debt in our consolidated statements of comprehensive income for the year ended December 31, 2023. This included unamortized debt issuance costs related to the extinguished 2019 Notes. Under modification accounting, the carrying amount of the modified 2019 Notes was reduced by $2.8 million, with the offset going to additional paid-in capital, to account for the increase in fair value of the embedded conversion option in the modification. The increase in principal, along with the increased option value, totaling $82.1 million, is reflected as a debt discount and is a direct reduction from the carrying value of the debt on our consolidated balance sheets. This amount will be accreted as an adjustment to interest expense using the effective interest method and will accrete up to the full face value of the 2023 Notes of $600.0 million.
Proceeds from the Subscription Transactions amounted to $276.1 million after debt issuance costs of $14.0 million. The exchange resulted in $6.2 million of the debt issuance costs related to the modified notes to be recorded to amortization of debt issuance costs in our 2023 consolidated statement of comprehensive income under the rules of modification accounting. The remaining debt issuance costs of $7.8 million as well as $0.7 million of unamortized costs carried over from the 2019 Notes at the exchange date, were capitalized within long-term debt (as a contra-liability) in our consolidated balance sheets and will be amortized as an adjustment to amortization of debt issuance costs over the five-year term of the 2023 Notes in our consolidated statement of comprehensive income. The carrying value of the 2023 Notes of $525.6 million is included in long-term debt on our consolidated balance sheets as of December 31, 2024.
Prior to the close of business on the business day immediately preceding September 15, 2028, the 2023 Notes will be convertible at the option of the holders of 2023 Notes only upon the satisfaction of specified conditions and during certain periods into cash up to their principal amount, and into cash, shares of the Company's common stock or a combination of cash and the Company's common stock, at the Company's election, for the conversion value above the principal amount, if any. Thereafter until the close of business on the second scheduled trading day immediately preceding the maturity date, the 2023 Notes will be convertible at the options of the holders of 2023 Notes at any time regardless of these conditions. The Company may redeem for cash, all or a portion of the 2023 Notes, at its option, on or after December 18, 2026 and prior to the 21st scheduled trading day immediately preceding the maturity date at a redemption price of 100% of the principal amount of the 2023 Notes to be redeemed, plus accrued and unpaid interest to, but excluding the redemption date, if certain conditions are met in accordance to the indenture.
During the fourth quarter of 2023, the closing price of the Company’s common stock exceeded 130% of the conversion price of the 2019 Notes for more than 20 trading days of the last 30 consecutive trading days of the quarter. As a result, the remaining $69.7 million aggregate principal amount of 2019 Notes were convertible at the option of the holders of the 2019 Notes during the first quarter of 2024. During 2024, $0.2 million aggregate principal amount of the 2019 Notes converted, bringing the remaining outstanding 2019 Notes to $69.5 million in aggregate principal amount. The remaining 2019 Notes matured and were paid off in full on July 15, 2024. The Company irrevocably elected to settle the conversion of the 2019 Notes using a combination of cash and the Company’s common stock, settling the par value of the 2019 Notes in cash and any excess conversion premium in shares. In connection with the conversion, the Company paid $69.6 million in cash, which included principal and accrued interest, and issued 100,944 shares of the Company’s common stock representing the conversion premium.
Stock-based compensation
We use the Black-Scholes option pricing model to calculate the fair value of stock option awards on the grant date. The expected term of options granted represents the period of time for which the options are expected to be outstanding and is derived from our historical stock option exercise experience and option expiration data. For purposes of estimating the expected term, we have aggregated all individual option awards into one group, as we do not expect substantial differences in exercise behavior among our employees. The expected volatility is a measure of the amount by which our stock price is expected to fluctuate during the expected term of options granted. We determined the expected volatility based upon the historical volatility of our common stock over a period commensurate with the option’s expected term. The risk-free interest rate is the implied yield available on U.S. treasury zero-coupon issues with a remaining term equal to the option’s expected term on the grant date. We have never declared or paid any cash dividends on any of our capital stock and do not expect to do so in the foreseeable future. Accordingly, we use an expected dividend yield of zero to calculate the grant-date fair value of a stock option.
The fair value for stock units, which include restricted stock units and performance stock units, is calculated using the closing price of the Company’s common stock on the date of grant. We recognize compensation expense on awards that vest based on service conditions on a straight-line basis over the requisite service period based upon the number of options that are ultimately expected to vest, and accordingly, such compensation expense has been adjusted by an amount of estimated forfeitures. We recognize compensation expense on awards that vest based on performance conditions following our assessment of the probability that the performance condition will be achieved over the service period. Forfeitures represent only the unvested portion of surrendered options, restricted stock units and performance stock units. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Based on an analysis of historical data, we have calculated an 8% annual forfeiture rate for non-executive level employees, a 3% annual forfeiture rate for executive level employees, and a 0% forfeiture rate for non-employee members of the Board of Directors (“Board”), which we believe are reasonable assumptions to estimate forfeitures. However, the estimation of forfeitures requires significant judgment and, to the extent actual results or updated estimates differ from our current estimates, a cumulative adjustment to stock-based compensation expense will be recorded in the period estimates are revised.
For the years ended December 31, 2024, 2023 and 2022, we recorded stock-based compensation expense of $48.1 million, $25.6 million and $27.3 million, respectively, for share-based awards granted under all of the Company’s stock plans.
As of December 31, 2024, there was $56.5 million of total unrecognized compensation cost related to unvested share-based awards. This cost is expected to be recognized over a weighted average remaining requisite service period of 2.7 years. We expect 2,305,232 unvested options and stock units to vest over the next five years.
Deferred taxes are determined based on the difference between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Valuation allowances are provided, if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. We account for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. We evaluate our tax position on a quarterly basis. We also accrue for potential interest and penalties related to unrecognized tax benefits in income tax expense. We are subject to a territorial tax system under the Tax Cuts and Jobs Act enacted in December 2017, in which we are required to provide for tax on Global Intangible Low-Taxed Income (“GILTI”) earned by certain foreign subsidiaries. We adopted an accounting policy to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense.
Recent accountingAccounting standards updatePronouncements
SeeFor more information about recent accounting pronouncements, refer to Note 2, “Summary of Significant Accounting Policies – Recent Accounting Standards Updates,” to our consolidated financial statements, included within Part IV, Item 15, “Exhibits and Financial Statement Schedules”, in this reportAnnual forReport moreon information.Form 10-K.
The following discussion of the financial condition and results of operations should be read in conjunction with the accompanying consolidated financial statements and the related footnotesfootnotes, thereto.included within Part IV, Item 15, “Exhibits and Financial Statement Schedules”, in this Annual Report on Form 10-K. All dollar and percentage changes made herein refer to the year ended December 31, 2025, compared with the year ended December 31, 2024, unless otherwise noted.
Total revenues for years ended December 31, 2024 and 2023 were comprised of the following:
Product revenuesrevenue
SinceWe 2016,are we have been increasinglycontinuously focused on selling our products directly to customers in the pharmaceuticallife industrysciences and topharmaceutical ourindustries, contractincluding manufacturers.CDMOs. These direct sales have represented 90.8% of our total product revenue during 2025 compared to 89.7% of our total product revenue during 2024 compared to 85.8% of our total product revenue in 2023.2024. Sales of our bioprocessing products can be impacted by the timing of large-scale production orders and the regulatory approvals for such antibodies, which may result in significant quarterly fluctuations.
Revenue from the sale of our products which make up our filtration, chromatography, process analytics and proteins franchises comes from the sale of a number of products as described in Part I, Item 1. “Business - Our Products” of this report. Other revenue primarily consists of revenue from the sale of our operating room products to hospitals as well as freight revenue.
In 2025, product revenue increased by $103.8 million, or 16.4% , compared to 2024. This growth is widespread across our portfolio of products and includes significant contributions from all our franchises. Geographically, product revenue increased 15.7% in North America, 16.0% in Europe and 19.3% in Asia Pacific and the rest of the world. Related to our acquisitions, products acquired from 908 Devices contributed $9.3 million in revenue during the year ended December 31, 2025. In addition, the year ended December 31, 2024 included $11.5 million of COVID-19 related sales.
In 2024, product revenue increased by $2.2 million, or 0.3%, as compared to 2023. The change is primarily driven by an increase of $31.6 million in our Filtration product revenue led by the success our of XCell ATF business. This increase was primarily offset by a decrease in our Proteins product revenue of $29.0 million, caused by headwinds in demand as Cytiva (a standalone operating company owned by Danaher Corporation) has moved certain ligand production in-house.
Royalty revenues
Royalty revenuesand other revenue for all periods presented relate to royalties received from a third-party systems manufacturer associated with our OPUS® chromatography columns. Royalty revenues are variable and are dependent on sales generated by our partner.partners.
In 2024, cost of goods sold increased $5.9 million, or 1.7%, compared to 2023, including an incremental $12.5 million of inventory adjustments compared to the prior year to reflect inventory at net realizable value, and an incremental $6.1 million charge compared to the prior year related to manufacturing facilities closed and equipment abandoned. These increases were partially offset by a decrease in accelerated depreciation of $3.8 million and a decrease in severance and employee related costs from restructuring of $1.2 million. See Note 6, “Restructuring Activities and Other Inventory-Related Charges” of this report for more information on the restructuring activities to simplify and streamline our organization and strengthen our overall effectiveness of our operations (“Restructuring Plan”). Our restructuring and other inventory-related activities include consolidating a portion of our manufacturing facilities between certain U.S. locations, writing-off abandoned equipment with the rationalization of excess production line capacity, discontinuing the sale of certain product SKUs, and evaluating the net realizable value of finished goods and raw materials. The non-cash inventory write-off in 2024 is the result of the Company discontinuing the sale of certain product SKUs and is also the result of the further evaluation of inventory positions in unusually turbulent market supply conditions. Where the value of finished goods and raw materials exceeded the projected requirements to be used before reaching their expiration date, or in a reasonable time horizon, they were written down to their realizable value.
The increase in restructuring changes was partially offset by a decrease in employee-related costs unrelated to the restructuring activities in 2024, as compared to 2023.
GrossIn margin2025, wascost 43.3%of ingoods 2024,sold decreased $7.8 million, or 2.2%, compared to 44.0%2024. The decrease in 2023.cost Theof reductiongoods in gross margin in 2024 as compared to 2023,sold is primarily due to lower costs related to scrap, excess and obsolete inventory and restructuring activities asin noted2025, abovecompared duringto 2024those incurred in 2024. Restructuring relates to activities to simplify and streamline our organization and strengthen the overall effectiveness of our operations,operations. whichThese decreases were $13.6partially millionoffset by higher inexport 2024duties, thandirect 2023.material Partiallyand offsettinglabor this increase in costs, margins increased as a result of a change in product mix.costs.
In 2025, gross margin was 52.3%, compared to 43.3% in 2024. The increase in gross margin resulted from the decrease in cost of goods sold as described above.
See Note 5, “Restructuring Activities and Other Inventory-Related Charges” in the notes to the consolidated financial statements, included within Part IV, Item 15, “Exhibits and Financial Statement Schedules”, in this Annual Report on Form 10-K, for more detail.
Research and development expenses (“R&D”) expenses are related to the development of products supporting bioprocessing products,operations, which include personnel,personnel compensation, supplies and other research expenses. Due to the fact that these various programs share personnel and fixed costs, we do not track all of our expenses or allocate any fixed costs by program, and therefore, have not provided historical costs incurred by project.
In 2025, R&D expenses increased $11.0 million, or 25.4%, compared to 2024. The increase in R&D costs is primarily driven by the 908 Devices PAT Portfolio and Tantti acquisitions, which have been included in our consolidated results of operations since the acquisition dates of March 2025 and December 2024, respectively.
R&D expenses increased $0.5 million, or 1.1%, during 2024, compared to 2023. The increase during the periods is primarily due to a $1.8 million increase in employee-related costs, partially offset by a decrease in product development costs of $1.4 million.
R&D expense also includes payments made to expand our proteins product offering through our development agreement with Navigo Proteins GmbH (“Navigo”). Such expenses were $3.1 million in 2024, $3.8 million in 2023, and $2.6 million in 2022 in the form of milestone payments to Navigo.
Selling, general and administrative (“SG&A”) expenses include the costs associated with selling our commercial products and costs required to support our marketing efforts,efforts. includingIt also includes legal, accounting, patent, shareholder services, amortization of intangible assets and other administrative functions.
What changed in the latest 10-Q
Risk Factors
New heading “We may be unable to complete the pending strategic acquisition of BioLife in a timely manner or at all, and even if we are able to complete the acquisition, we may be unable to successfully integrate BioLife’s business, any of which could adversely affect our business and financial condition.”
New heading “Even if we are able to complete the acquisition, we may be unable to successfully and efficiently integrate BioLife’s business into the Repligen enterprise following the closing.”
New heading “Our assumptions around the size and trajectory of the cell therapy market and BioLife’s market position may prove to be incorrect, which, along with other risks and uncertainties related to the BioLife transaction, could materially and adversely affect our business and financial results.”
Largest changes
“We may be unable to complete the pending strategic acquisition of BioLife in a timely manner or at all, and even if we are able to complete the acquisition, we may be unable to successfully integrate BioLife’s business, any of which could adversely affect our business and financial condition.”see in full comparison
“Our assumptions around the size and trajectory of the cell therapy market and BioLife’s market position may prove to be incorrect, which, along with other risks and uncertainties related to the BioLife transaction, could materially and adversely affect our business and financial results.”see in full comparison
“Even if we are able to complete the acquisition, we may be unable to successfully and efficiently integrate BioLife’s business into the Repligen enterprise following the closing.”see in full comparison
“The pending strategic acquisition of BioLife is subject to various closing conditions, many of which are outside of our control. Our inability to complete the pending acquisition of BioLife in a timely manner or at all could have a material adverse effect on our business as our ability to execute on our long-term strategy depends in part on our ability to engage in transactions and collaborations with other entities that add to our pipeline or provide us with new commercial opportunities. …”see in full comparison
“Other risks and uncertainties related to the BioLife transaction that could materially and adversely affect our business and financial results include the risk that the parties have overestimated the size or trajectory of the cell therapy market and BioLife’s market position, as well as the possibility that the anticipated financial impact and revenue growth of the transaction will not be realized when expected or at all, including as a result of the impact of, or problems arising from, the integration of the two companies or as a result of the strength of the economy and competitive factors …”see in full comparison
“Realization of the value from the pending acquisition of BioLife relies on successful and efficient integration following the closing. We may not be able to integrate BioLife’s business successfully into our existing business, retain key employees or realize the anticipated cost savings or synergies from this pending acquisition, which could adversely affect our business and financial condition. …”see in full comparison
Full comparison: every changed paragraph (7)
The matters discussed in this Quarterly Report on Form 10-Q include forward-looking statements that involve risks or uncertainties. These statements are neither promises nor guarantees, but are based on various assumptions by management regarding future circumstances, over many of which Repligen has little or no control. A number of important risks and uncertainties, including those identified under the caption “Risk Factors” in Part I, Item 1A of our Form 10-K for the period ended December 31, 2025 and in subsequent filings, could cause our actual results to differ materially from those in the forward-looking statements. ThereThe areinformation nopresented materialbelow changes tosupplements the riskrisks factorsand describeduncertainties identified under the caption “Risk Factors” in Part I, Item 1A of our Form 10-K for the period ended December 31, 2025.
We may be unable to complete the pending strategic acquisition of BioLife in a timely manner or at all, and even if we are able to complete the acquisition, we may be unable to successfully integrate BioLife’s business, any of which could adversely affect our business and financial condition.
The pending strategic acquisition of BioLife is subject to various closing conditions, many of which are outside of our control. Our inability to complete the pending acquisition of BioLife in a timely manner or at all could have a material adverse effect on our business as our ability to execute on our long-term strategy depends in part on our ability to engage in transactions and collaborations with other entities that add to our pipeline or provide us with new commercial opportunities. Further, an event, change or other circumstances could occur that would prevent, materially delay or materially impair the ability of us or BioLife to consummate the acquisition, or that has or would reasonably be expected to have, a material adverse effect on the financial condition, business or results of operations of us or BioLife, which could give rise to the right of one or both of the parties to terminate the Merger Agreement, which could have a negative impact on our long-term strategy, financial results and operations.
Even if we are able to complete the acquisition, we may be unable to successfully and efficiently integrate BioLife’s business into the Repligen enterprise following the closing.
Realization of the value from the pending acquisition of BioLife relies on successful and efficient integration following the closing. We may not be able to integrate BioLife’s business successfully into our existing business, retain key employees or realize the anticipated cost savings or synergies from this pending acquisition, which could adversely affect our business and financial condition. Such efforts, whether successful or not, could cause a diversion of BioLife and Repligen management’s attention from ongoing business operations and other opportunities and could give rise to potential adverse reactions or changes to business or employee relationships, any which could have a material and adverse impact on our business.
Our assumptions around the size and trajectory of the cell therapy market and BioLife’s market position may prove to be incorrect, which, along with other risks and uncertainties related to the BioLife transaction, could materially and adversely affect our business and financial results.
Other risks and uncertainties related to the BioLife transaction that could materially and adversely affect our business and financial results include the risk that the parties have overestimated the size or trajectory of the cell therapy market and BioLife’s market position, as well as the possibility that the anticipated financial impact and revenue growth of the transaction will not be realized when expected or at all, including as a result of the impact of, or problems arising from, the integration of the two companies or as a result of the strength of the economy and competitive factors in the areas where we and BioLife do business; the outcome of any legal proceedings that may be instituted against us or BioLife in connection with the transaction or otherwise; the potential for increased regulatory scrutiny and the impact on the clinical pipeline, global approvals and expanded indications; the possibility that the transaction may be more expensive to complete than anticipated; and risks relating to the potential dilutive effect of shares of our common stock to be issued in the transaction.
Management's Discussion & Analysis (MD&A)
Removed heading “Acquisition of 908 Devices PAT Portfolio”
Largest changes
“At the closing of the Transaction, BioLife stockholders will be entitled to $11.25 in cash per share plus 0.1442 shares of Repligen common stock per BioLife share. …”see in full comparison
This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of federal securities laws, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The forward-looking statements in this Quarterly Report on Form 10-Q do not constitute guarantees of future performance. Investors are cautioned that statements in this Quarterly Report on Form 10-Q which are not strictly historical statements, including, without limitation, express or implied statements or guidance regarding current or future financial performance and position, potential impairment of future earnings, management’s strategy, plans and objectives for future operations or acquisitions, expectations and beliefs for the Company’s acquisitions and divestitures, product development and sales, restructuring activities and the expected results thereof, product candidate research, development and regulatory approval, SG&A expenditures, intellectual property, development and manufacturing plans, availability of materials and product and adequacy of capital resources, and our financingsee in full comparisonplans.plans, constitute forward-looking statements. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates, and management’s beliefs and assumptions. The Company undertakes no obligation to publicly update or revise the statements in light of future developments. In addition, other written and oral statements that constitute forward-looking statements may be made by the Company or on the Company’s behalf. Words such as “expect,” “seek,” “anticipate,” “intend,” “plan,” “believe,” “could,” “estimate,” “may,” “target,” “project,” or variations of such words and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with the following: the success of current and future collaborative or supply relationships; our ability to successfully grow our bioprocessing business, including as a result of acquisitions, commercialization or partnership opportunities, and our ability to develop and commercialize products; our ability to obtain required regulatory approvals; our compliance with all U.S. Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products; the risk of litigation regarding our patent and other intellectual property rights; the risk of litigation with collaborative partners; our manufacturing capabilities and our dependence on third-party manufacturers and value-added resellers; our ability to hire and retain skilled personnel; the market acceptance of our products, reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition; our ability to integrate acquired businesses successfully into our business and achieve the expected benefits of theacquisitions;acquisitions,projectionsincluding the anticipated synergies and other benefits oftarifftheimpactsBioLife transaction; our ability to complete pending acquisitions, including the pending acquisition of BioLife; our ability to compete with larger, better financed life sciences companies; our history of losses and expectation of incurring losses; our ability to generate future revenues; our ability to successfully integrate acquired businesses; our ability to raise additional capital to fund potential acquisitions; our plans to mitigate our material weaknesses in our internal controls over financial reporting; our volatile stock price; and the effects of our anti-takeover provisions. Further information on potential risk factors that could affect our financial results are included in the filings made by us from time to time with the SEC including under the sections entitled “Risk Factors” in our Form10-K.10-K and in Part II, Item 1A of this Quarterly Report on Form 10-Q. We assume no obligation to update any forward-looking information contained in this Form 10-Q, except as required by law.
see in full comparisonWe have been monitoring the effects of tariffs implemented by the Trump administration and the potential imposition of modified or additional tariffs.On February 20, 2026, the U.S. Supreme Court rendered a decision invalidating tariffs imposed by the Trump administration under the International Emergency Economic PowersAct.Act (“IEEPA”). This decision introduces uncertainty regardingthe refund process andfuture trade policy actions and could impact our cost structure and supply-chain planning. We will continue to monitor the effects of tariffs implemented by the Trump administration and the potential imposition of modified or additional tariffs.
Interest expense increased by $0.3 million and $0.6 million for the three and six months endedsee in full comparisonMarchJune31,30,20262026, respectively, as compared to the sameperiodperiods in 2025. Interest expense includes contractual coupon interest onourtheoutstanding2023convertibleNotes,notesas defined below, and the associated accretion of the discount. The discount is being accreted into interest expense using the effective interest method over the term of the 2023Notes, as defined below.Notes. See Note 8, “Convertible Senior Notes” to our condensed consolidated financial statements included in this report for more information.
“For the three months ended March 31, 2026, our operating activities provided cash of $28.3 million reflecting net income of $8.3 million and non-cash charges totaling $41.9 million primarily related to depreciation and intangible amortization, loss on sale of Polymem, stock-based compensation, operating lease right of use asset amortization and amortization of debt discount and issuance costs, partially offset by changes in deferred income taxes, net and other non-cash items. The non-cash charges were partially offset by unfavorable changes in working capital of $21.9 million. …”see in full comparison
Full comparison: every changed paragraph (40)
We have been monitoring the effects of tariffs implemented by the Trump administration and the potential imposition of modified or additional tariffs. On February 20, 2026, the U.S. Supreme Court rendered a decision invalidating tariffs imposed by the Trump administration under the International Emergency Economic Powers Act.Act (“IEEPA”). This decision introduces uncertainty regarding the refund process and future trade policy actions and could impact our cost structure and supply-chain planning. We will continue to monitor the effects of tariffs implemented by the Trump administration and the potential imposition of modified or additional tariffs.
2025 AcquisitionAcquisitions
On July 21, 2026, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) to acquire all of the outstanding shares of common stock of BioLife Solutions, Inc. (“BioLife”), a publicly traded company focused on developing cell processing tools and services for the cell and gene therapy market, for approximately $1.5 billion, comprised of approximately 64% in our common stock and 36% in cash (the “Transaction”). We will account for the acquisition in the period the Transaction closes, which closing is expected to occur in the fourth quarter of 2026. We expect that the cash portion of the merger consideration will be funded with cash and cash equivalents on hand.
At the closing of the Transaction, BioLife stockholders will be entitled to $11.25 in cash per share plus 0.1442 shares of Repligen common stock per BioLife share. The Transaction is subject to customary closing conditions, including (among others) (i) the adoption and approval of the Merger Agreement by the holders of a majority of the outstanding shares of BioLife common stock; (ii) the absence of any adverse law or order that restrains, enjoins, makes illegal or otherwise prohibits the consummation of the Transaction; (iii) the shares of our common stock to be issued in connection with the Transaction (the “Merger Shares”) being approved for listing on The Nasdaq Stock Market; (iv) the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended; (v) the U.S. Securities and Exchange Commission (the “SEC”) having declared effective the Registration Statement on Form S-4 to be filed by Repligen to register the Merger Shares; (vi) subject to certain materiality exceptions, the accuracy of certain representations and warranties of each of Repligen and BioLife contained in the Merger Agreement and the compliance by each party with the covenants contained in the Merger Agreement; and (vii) the absence of a continuing material adverse effect with respect to each of Repligen and BioLife. The Transaction with BioLife will bring a differentiated portfolio of products including a market-leading bio preservation media platform and other cell processing tools while expanding our presence in the cell therapy market.
Acquisition of 908 Devices PAT Portfolio
The following discussion of our financial condition and results of operations should be read in conjunction with the accompanying condensed consolidated financial statements and the related footnotes in this Quarterly Report on Form 10-Q. All dollar and percentage changes made herein refer to the three and six months ended MarchJune 31,30, 2026, compared with the three and six months ended MarchJune 31,30, 2025, unless otherwise noted. Certain prior year amounts have been reclassified to conform with the current year presentation.
Total revenues for the three and six months ended MarchJune 31,30, 2026 and 2025 were as follows:
During the three and six months ended MarchJune 31,30, 2026, product revenue increased by $25.1$21.8 million, or 14.8%,11.9%, and $46.8 million, or 13.3%, respectively, as compared to the same period in 2025. This growth is widespread across our portfolio of products and includes significant contributions from all our franchises. Geographically, product revenue increased 4.8% in North America, 22.9% in Europe and 29.4% in Asia Pacific and the rest of the world. Related to our acquisitions, products acquired from 908 Devices PAT Portfolio contributed $2.4 million in revenue during the three months ended March 31, 2026.
During the three months ended June 30, 2026, product revenue increased 43.3% in Asia Pacific and the rest of the world and 17.3% in North America, and decreased 6.1% in Europe. During the six months ended June 30, 2026, product revenue increased 36.1% in Asia Pacific and the rest of the world, 11.2% in North America, and 7.2% in Europe.
Royalty and other revenues in the three and six months ended MarchJune 31,30, 2026 and 2025 relate to royalties received from a third-party systems manufacturer associated with our OPUS® chromatography columns. Royalty revenues are variable and are dependent on sales generated by our partners.
Total costs and operating expenses for the three and six months ended MarchJune 31,30, 2026 and 2025 were comprised of the following:
During the three and six months ended MarchJune 31,30, 2026, cost of goods sold increased by $8.2$4.7 million, or 10.5%5.3%, and $12.9 million, or 7.7%, respectively, compared to the same period in 2025. Gross margin increased to 55.7%53.9% for the three months ended MarchJune 31,30, 20262026, compared to 54.0%51.0% for the same period in 2025. Gross margin increased to 54.8% for the six months ended June 30, 2026, compared to 52.4% for the same period in 2025. The increase in cost of goods sold is primarily driven by higher product sales compared to the same periodperiods in 2025, partially offset by improved leverage on indirect labor and overhead. The increase in gross margin is driven by higher product sales, favorable product mix and improved leverage on indirect labor and overhead.
R&D expenses increased by $2.3$0.4 million, or 19.3%3.2%, and $2.8 million, or 10.7%, respectively, during the three and six months ended MarchJune 31,30, 2026, as compared to the same period in 2025. The primary driver of the increase in R&D costs during the six months ended June 30, 2026 is primarilyincremental drivenR&D byfrom the 908 Devices PAT Portfolio acquisition which have been included in our consolidated results of operations since March 2025.acquisition.
SG&A costs increased by $5.8$5.7 million, or 8.1%, and $11.5 million, or 8.2%, respectively, during the three and six months ended MarchJune 31,30, 2026 as compared to the same period in 2025. The primary driver of the increase in SG&A costs is investment in personnel costs to support growth, driven by increased headcount.
Restructuring activities and other charges decreasedincreased by $0.5$0.6 million, or 24.2%,25.7%, during the three months ended MarchJune 31,30, 2026 as compared to the same period in 2025.
During the first quarter of 2026, we initiated a series of restructuring activities to simplify the global manufacturing footprint of the organization and align itsour workforce to support long-term company growth. These activities will include a series of site optimization phases with the purpose of improving operating efficiency.efficiency and are expected to be completed by the end of 2027.
The table below provides detail regarding our other income (expense) income,, net:
Investment income includes income earned on cash, cash equivalents and marketable securities. Our investment income decreased by $1.0$0.2 million and $1.1 million for the three and six months ended MarchJune 31,30, 2026, respectively, as compared to the same periodperiods in 2025 due to a reduction in interest rates. We expect investment income to vary based on changes in the amount of funds invested and fluctuation of interest rates.
Interest expense increased by $0.3 million and $0.6 million for the three and six months ended MarchJune 31,30, 20262026, respectively, as compared to the same periodperiods in 2025. Interest expense includes contractual coupon interest on ourthe outstanding2023 convertibleNotes, notesas defined below, and the associated accretion of the discount. The discount is being accreted into interest expense using the effective interest method over the term of the 2023 Notes, as defined below.Notes. See Note 8, “Convertible Senior Notes” to our condensed consolidated financial statements included in this report for more information.
On March 30, 2026, we completed the sale of Polymem S.A.S. (“Polymem”) for total consideration of approximately$3.6 $4.4million, million.net of cash divested. We recognized a net loss on the sale of business of $13.7 million during the threesix months ended MarchJune 31,30, 2026 of $13.8 million.2026.
Other expense, net increased by $0.5$3.8 million and $4.2 million for the three and six months ended MarchJune 31,30, 20262026, respectively, as compared to the same period in 2025. Other expense, net primarily includes the changes in foreign currency transaction gains and losses, revaluation impact of intercompany loans with subsidiaries and unrealized and realized impacts of foreign exchange forward contracts.
Income tax (benefit) provision for the three and six months ended MarchJune 31,30, 2026 and 2025 was as follows:
For the three and six months ended MarchJune 31,30, 2026, we recorded an income tax benefitprovision of $6.6$9.1 million.million and $2.6 million, respectively. The effective tax rate was (370.3)%64.6% and 16.2% for the three and six months ended MarchJune 31,30, 20262026, respectively, and is based upon the estimated income for the year ending December 31, 2026 and the composition of income in different jurisdictions.
The difference in effective tax rates between the periods was primarily due to the Polymem divestiture offset by lower stockcontingent windfallconsideration tax benefits. Our effective tax rate for the three months ended MarchJune 31,30, 2026 was higher than the U.S. statutory rate of 21% primarily due to additional discrete expense related to the Polymem Divestiture. Our effective tax rate for the six months ended June 30, 2026 was lower than the U.S. statutory rate of 21% primarily due to the Polymem divestiture.
The conditional conversion features of the 2023 Notes were not triggered during the calendar quarter ended MarchJune 31,30, 2026, therefore, the 2023 Notes are not convertible during the calendar quarter ended JuneSeptember 30, 2026 pursuant to the applicable last reported sales price conditions, as stated in the indenture governing the 2023 Notes.
For the three months ended March 31, 2026, our operating activities provided cash of $28.3 million reflecting net income of $8.3 million and non-cash charges totaling $41.9 million primarily related to depreciation and intangible amortization, loss on sale of Polymem, stock-based compensation, operating lease right of use asset amortization and amortization of debt discount and issuance costs, partially offset by changes in deferred income taxes, net and other non-cash items. The non-cash charges were partially offset by unfavorable changes in working capital of $21.9 million. This is primarily driven by increases in inventories of $12.1 million, net decreases in accounts payable and accrued liabilities of $6.7 million due to timing of payments to vendors and compensation, decreases in operating lease liabilities of $5.6 million, primarily due to normal course rent payments and increases in prepaid expenses and other current assets of $2.0 million, partially offset by decreases in accounts receivable of $3.2 million due to timing of sales and receipts from customers and increases in noncurrrent liabilities of $1.3 million. The remaining cash provided by operating activities resulted from net favorable changes in various other working capital accounts.
For the threesix months ended MarchJune 31,30, 2025,2026, our operating activities provided cash of $15.0$61.1 million reflecting net income of $5.8$13.3 million and non-cash charges totaling $35.6$82.6 million primarily related to depreciation and intangible amortization, unrealized loss on derivatives,sale of Polymem, stock-based compensation, operating lease right of use asset amortization,amortization and amortization of debt discount and issuance costs, partially offset by net unrealized foreign exchange gains. The non-cash charges were partially offset by unfavorable changes in workingdeferred capitalincome oftaxes, $26.4 million. This is primarily driven by an increase accounts receivable of $9.9 million due to timing of salesnet and receipts from customers, accounts payable and accrued expenses used cash of $4.9 million due to timing of payments to vendors, and inventory manufactured used cash of $3.8 million. The remaining cash used in operating activities resulted from unfavorable changes in various other workingnon-cash capital accounts.items.
The non-cash charges were partially offset by unfavorable changes in working capital of $34.9 million. This is primarily driven by increases in inventories of $20.2 million, increases in accounts receivable of $4.4 million due to timing of sales and receipts from customers, increases in prepaid expenses and other current assets of $6.0 million, and decreases in operating lease liabilities of $13.4 million, primarily due to normal course rent payments, partially offset by net increases in accounts payable and accrued liabilities of $5.6 million due to timing of payments to vendors and compensation. The remaining cash provided by operating activities resulted from net favorable changes in various other working capital accounts.
For the six months ended June 30, 2025, our operating activities provided cash of $43.6 million reflecting net income of $20.7 million and non-cash charges totaling $61.4 million primarily related to depreciation and intangible amortization, stock-based compensation, operating lease right of use asset amortization, and amortization of debt discount and issuance costs, partially offset by net unrealized foreign exchange gains and contingent consideration adjustment. The non-cash charges were partially offset by unfavorable changes in working capital of $38.5 million. This is primarily driven by an increase in accounts receivable of $15.2 million due to timing of sales and receipts from customers, accounts payable and accrued expenses used cash of $11.3 million due to timing of payments to vendors, leases for normal course rent payments of $9.8 million, and inventory manufactured used cash of $0.8 million.
Our investing activities consumed $4.0$6.1 million of cash during the threesix months ended MarchJune 31,30, 2026, which was primarily driven by purchases of marketable securities of $64.6$130.7 million and capital expenditures of $4.9$11.0 million, inclusive of $0.2$1.0 million of capitalized costs related to our internal-use software. This was partially offset by maturities of marketable securities of $66.0$132.0 million and proceeds received, net of cash divested from our sale of Polymem of $3.6 million.
Our investing activities consumed $74.1$81.9 million of cash during the threesix months ended MarchJune 31,30, 2025, which was primarily driven by the acquisition of the 908 Devices PAT Portfolio, net of cash acquired, of $69.7$69.9 million. Capital expenditures during the threesix months ended MarchJune 31,30, 2025 consumed $4.4$12.0 million, including $0.9$1.4 million of capitalized costs related to our internal-use software.
Our financing activities consumed $5.5$11.7 million of cash for the threesix months ended MarchJune 31,30, 2026, which was primarily driven by cash disbursed related to the tax withholding obligation on vesting of restricted stock units.units for $6.6 million and cash payments for a portion of the contingent earnout obligation related to the acquisition of Tantti for $5.2 million.
Our financing activities consumed $5.0$15.2 million of cash for the threesix months ended MarchJune 31,30, 2025, drivenpredominantly bydue $6.5to $7.2 million in cash disbursed for shares withheld to cover employee income tax due upon the vesting and release of restricted stock units. This cash consumption wasunits, partially offset by $1.5proceeds million of proceedsreceived from the exercise of stock optionsoption exercises during the period.period of $1.5 million. In addition, we made payments of $2.6 million and $6.9 million to settle the cash portion of the contingent earnout obligations related to our acquisition of FlexBiosys in April 2023 and Avitide in September 2021, respectively.
The effect of exchange rate changes on cash during the three and six months ended MarchJune 31,30, 2026, is a result of using multiple currencies across the group, with the Euro and Swedish Krona being significant currencies for the group outside of the US Dollar.
change in accounting standards;
Additionally and as described above, on July 21, 2026, we entered into the Merger Agreement to acquire all outstanding shares of common stock of BioLife, for approximately $1.5 billion, comprised of approximately 64% in our common stock and 36% in cash. The Transaction is expected to close in the fourth quarter of 2026, subject to certain customary closing conditions described above. We intend to fund the cash portion of the consideration with cash and cash equivalents on hand.
Aside from items discussed herein, there have been no other material changes to our future capital requirements or contractual obligations disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 26, 2026.
Absent acquisitions of additional businesses, products, product candidates or intellectual property,property not reflected herein, we believe our current cash balancesliquidity and future cash flow from operations are adequate to meet our cash needs for at least one year from this Quarterly Report on 10-Q. We expect operating expenses in 2026 to increase as we continue to expand our bioprocessing business. We expect to incur continued spending related to the development and expansion of our bioprocessing product lines and expansion of our commercial capabilities for the foreseeable future. Our future capital requirements may include, but are not limited to, purchases of property, plant and equipment, the acquisition of additional bioprocessing products and technologies to complement our existing manufacturing capabilities, continued investment in our intellectual property portfolio and financing activities to service our outstanding convertible notes.
We plan to continue to invest in our bioprocessing business and in key R&D activities associated with the development of new bioprocessing products. We actively evaluate various strategic transactions on an ongoing basis, including licensing, acquiring or investing in complementary products, technologies or businesses that would complement our existing portfolio. We continue to seek to acquire or invest in such potential assets that may offer us the best opportunity to create value for our shareholders. In order to do so, we may need to seek additional financing to fund these investments. If our available cash balances and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements, for example, due to acquisition-related financing needs, servicing of our outstanding indebtedness or lower demand for our products, among potential other events, we may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding, or seek other debt funding. The sale of equity and convertible debt securities may result in dilution to our shareholders, and those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights. We may require additional capital beyond our currently anticipated amounts. Additional capital may not be available on reasonable terms, if at all.
This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of federal securities laws, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The forward-looking statements in this Quarterly Report on Form 10-Q do not constitute guarantees of future performance. Investors are cautioned that statements in this Quarterly Report on Form 10-Q which are not strictly historical statements, including, without limitation, express or implied statements or guidance regarding current or future financial performance and position, potential impairment of future earnings, management’s strategy, plans and objectives for future operations or acquisitions, expectations and beliefs for the Company’s acquisitions and divestitures, product development and sales, restructuring activities and the expected results thereof, product candidate research, development and regulatory approval, SG&A expenditures, intellectual property, development and manufacturing plans, availability of materials and product and adequacy of capital resources, and our financing plans.plans, constitute forward-looking statements. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates, and management’s beliefs and assumptions. The Company undertakes no obligation to publicly update or revise the statements in light of future developments. In addition, other written and oral statements that constitute forward-looking statements may be made by the Company or on the Company’s behalf. Words such as “expect,” “seek,” “anticipate,” “intend,” “plan,” “believe,” “could,” “estimate,” “may,” “target,” “project,” or variations of such words and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with the following: the success of current and future collaborative or supply relationships; our ability to successfully grow our bioprocessing business, including as a result of acquisitions, commercialization or partnership opportunities, and our ability to develop and commercialize products; our ability to obtain required regulatory approvals; our compliance with all U.S. Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products; the risk of litigation regarding our patent and other intellectual property rights; the risk of litigation with collaborative partners; our manufacturing capabilities and our dependence on third-party manufacturers and value-added resellers; our ability to hire and retain skilled personnel; the market acceptance of our products, reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition; our ability to integrate acquired businesses successfully into our business and achieve the expected benefits of the acquisitions;acquisitions, projectionsincluding the anticipated synergies and other benefits of tariffthe impactsBioLife transaction; our ability to complete pending acquisitions, including the pending acquisition of BioLife; our ability to compete with larger, better financed life sciences companies; our history of losses and expectation of incurring losses; our ability to generate future revenues; our ability to successfully integrate acquired businesses; our ability to raise additional capital to fund potential acquisitions; our plans to mitigate our material weaknesses in our internal controls over financial reporting; our volatile stock price; and the effects of our anti-takeover provisions. Further information on potential risk factors that could affect our financial results are included in the filings made by us from time to time with the SEC including under the sections entitled “Risk Factors” in our Form 10-K.10-K and in Part II, Item 1A of this Quarterly Report on Form 10-Q. We assume no obligation to update any forward-looking information contained in this Form 10-Q, except as required by law.
RGEN 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 8 filings (2 insiders, 8 trade dates, 37,463 shares, about $6.7M; 8 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -37,463 (purchases minus sales); net value about -$6.7M.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 |
|---|---|---|---|---|---|
| 2026-10-05 | Loeillot Olivier |
Open-market sale |
1,333 | $178.75 | $238.3K |
| 2026-10-05 | Loeillot Olivier |
Option exercise |
4,202 | $154.96 | $651.1K |
| 2026-10-05 | Loeillot Olivier |
Open-market sale |
4,202 | $190.00 | $798.4K |
| 2026-10-02 | Loeillot Olivier |
Shares withheld for tax | 1,248 | $181.70 | $226.8K |
| 2026-09-25 | Garland Jason K |
Shares withheld for tax | 421 | $189.68 | $79.9K |
| 2026-09-24 | Loeillot Olivier |
Open-market sale |
8,404 | $190.00 | $1.6M |
| 2026-09-24 | Loeillot Olivier |
Option exercise |
8,404 | $154.96 | $1.3M |
| 2026-09-24 | Loeillot Olivier |
Option exercise |
4,542 | $155.38 | $705.7K |
| 2026-09-24 | Loeillot Olivier |
Open-market sale |
4,542 | $190.00 | $863.0K |
| 2026-09-21 | Loeillot Olivier |
Option exercise |
5,426 | $141.79 | $769.4K |
| 2026-09-21 | Loeillot Olivier |
Open-market sale |
5,426 | $180.00 | $976.7K |
| 2026-09-04 | Loeillot Olivier |
Open-market sale |
3,035 | $165.90 | $503.5K |
| 2026-09-03 | Loeillot Olivier |
Shares withheld for tax |
2,842 | $169.61 | $482.0K |
| 2026-09-01 | Hughes Violetta |
Shares withheld for tax | 277 | $170.02 | $47.1K |
| 2026-08-20 | Loeillot Olivier |
Open-market sale |
5,426 | $180.00 | $976.7K |
| 2026-08-20 | Loeillot Olivier |
Option exercise |
5,426 | $141.79 | $769.4K |
| 2026-07-16 | Garland Jason K |
Open-market sale |
530 | $150.00 | $79.5K |
| 2026-06-25 | Garland Jason K |
Open-market sale |
733 | $145.00 | $106.3K |
| 2026-05-14 | Konstantinov Konstantin |
Grant/award | 995 | — | — |
| 2026-05-14 | Madaus Martin D |
Grant/award | 995 | — | — |
| 2026-05-14 | Eglinton Manner Carrie |
Grant/award | 995 | — | — |
| 2026-05-14 | Muir Glenn P |
Grant/award | 995 | — | — |
| 2026-05-14 | Mhatre Rohin |
Grant/award | 995 | — | — |
| 2026-05-14 | Pax Margaret |
Grant/award | 995 | — | — |
| 2026-05-14 | Dawes Karen A |
Grant/award | 995 | — | — |
| 2026-05-14 | Barthelemy Nicolas |
Grant/award | 995 | — | — |
| 2026-05-07 | Muir Glenn P |
Option exercise | 2,434 | $38.76 | $94.3K |
| 2026-05-07 | Douglass Brian Robb |
Shares withheld for tax | 334 | $126.43 | $42.2K |
| 2026-04-21 | Loeillot Olivier |
Open-market sale |
3,832 | $140.00 | $536.5K |
| 2026-03-05 | Hughes Violetta |
Grant/award | 2,466 | — | — |
Well-known investors holding RGEN (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 376,309 | $51.3M | 0.03% | Reduced 66% |
| PRIMECAP Management | 2026-06-30 | 323,268 | $44.1M | 0.03% | Added 38% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 166,157 | $22.7M | 0.03% | Reduced 71% |
| Gotham Asset Management (Joel Greenblatt) | 2026-06-30 | 142,613 | $19.5M | 0.05% | Added 396% |
| D. E. Shaw & Co. | 2026-06-30 | 83,328 | $11.4M | 0.01% | New position |
| Oaktree Capital Management (Howard Marks) | 2026-06-30 | 0 | $8.8M | — | Sold out |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 0 | $4.9M | — | Sold out |
| Millennium Management (Israel Englander) | 2026-06-30 | 22,461 | $2.6M | — | Sold out |
| Two Sigma Investments | 2026-06-30 | 9,901 | $1.4M | 0.0% | New position |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 8,936 | $1.2M | 0.0% | Added 1% |
| Millennium Management (Israel Englander) | 2026-06-30 | 0 | $928.6K | 0.0% | New position |
| Duquesne Family Office (Stanley Druckenmiller) | 2026-06-30 | 77,400 | $10.6K | 0.24% | New position |