What the changes say
- Repligen added new risks regarding joint ventures, ongoing IT and inventory material weaknesses, ESG reporting, and cyber threats.
- The company updated financial health care disclosures to reference the OBBBA enacted in July 2025.
What changed since the prior 10-K
New
- NewRisks Related to Product Development, Strategic Investments, Collaborations and Acquisitions
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
We face risks regarding intellectual property disputes, operational oversight, unfamiliar foreign regulations, and liquidity for minority investments and joint ventures.
- NewRisks Related to Product Development, Strategic Investments, Collaborations and Acquisitions
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
Joint ventures or collaborations may terminate early or fail to deliver anticipated benefits or revenues.
- NewRisks Related to Investment in Our Securities
Effective internal controls are necessary to provide reliable financial reports and to assist in the effective prevention of fraud. Any
We must maintain effective internal controls under Sarbanes-Oxley, but our systems can only provide reasonable assurance against misstatements or fraud.
- NewRisks Related to Investment in Our Securities
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)
We had material weaknesses in IT general controls, including logical access and program change management, affecting automated and business process controls.
- NewRisks Related to Investment in Our Securities
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
Although our revenue recognition weakness was remediated, material weaknesses in IT general controls and inventory valuation and financial close processes persisted as of December 31, 2025.
- NewRisks Related to Investment in Our Securities
Upon identifying the revenue recognition material weakness described above, we amended and restated certain items in our Quarterly
Restatements of prior financial reports for 2023 and early 2024 incurred accounting and legal costs and could trigger regulatory investigations or shareholder litigation.
- NewRisks Related to Regulations and Compliance
If our ESG practices do not meet evolving investor, regulatory, or industry expectations, our reputation, investor confidence, and
Failure to meet stakeholder ESG expectations or comply with EU sustainability regulations could increase costs and harm our reputation and employee retention.
- NewRisks Related to Data and Privacy
Despite the implementation of security measures, our internal computer systems and those of our customers, collaborators cloud-based
Cyber-attacks, malware, insider threats, and AI-facilitated breaches could compromise our sensitive employee data, intellectual property, and business operations.
- NewRisks Related to Our Intellectual Property
validity and enforceability of the patent claims
Expiration or invalidation of Protein A patent claims in litigation could increase competition and force us to lower prices or lose market share.
- NewRisks Related to Our Intellectual Property
Our freedom to develop, manufacture or sell products may be challenged by others, and we may engage in litigation which, if we do not prevail, could harm our business, results of operations, financial condition, cash flow and future prospects
We may engage in costly intellectual property litigation to enforce our patents or defend against third-party infringement claims.
- NewRisks Related to Our Intellectual Property
and result in loss of protection
Foreign patent applications may face costly third-party opposition proceedings resulting in a loss of protection.
- NewRisks Related to Our Intellectual Property
We may initiate litigation or other proceedings against third parties who misappropriate trade secrets or otherwise breach confidentiality obligations
Uncertainties from pending patent litigation can divert management resources and impair our ability to compete.
Dropped
- DroppedRisks Related to Our Business
customers may place fewer orders with us or cease placing orders with us, which would negatively affect our revenues and operating results
- DroppedRisks Related to Investment in Our Securities
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
- DroppedRisks Related to Investment in Our Securities
Expanding the management and governance over IT system controls
- DroppedRisks Related to Investment in Our Securities
Assessing the frequency of our control monitoring activities to ensure that they are conducted in a timely manner; and
- DroppedRisks Related to Data and Privacy
Our internal computer systems, or those of our customers, collaborators or other contractors, may be subject to cyber-attacks or security incidents or compromises, which could result in a material disruption of our product development programs
Unforeseen adverse events in gene therapies could harm customer demand for our products.
- DroppedRisks Related to Our Intellectual Property
Patents that may be granted to us in certain foreign countries may be subject to opposition proceedings brought by third parties or result in suits by us, which may be costly and result in adverse consequences for us
- DroppedRisks Related to Our Intellectual Property
While we continue to obtain patent grants directed towards Protein A, other patent grants directed towards Protein A have expired, and as a result, we may face increased competition, which could harm our results of operations, financial condition, cash flow and future prospects
- DroppedRisks Related to Our Intellectual Property
There has been substantial litigation and other proceedings regarding the complex patent and other intellectual property rights in the life sciences industry. We have been a party to, and in the future may become a party to, patent litigation or other proceedings regarding intellectual property rights
- DroppedRisks Related to Our Intellectual Property
If third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights, we will need to defend against such claims
Reworded
- 99% rewrittenRisks Related to Regulations and Compliance
Climate change, climate change-related regulation and sustainability concerns could adversely affect our businesses and the operations of our subsidiaries, and any actions we take or fail to take in response to such matters could damage our reputation
Added specific mention of the European Union's Corporate Sustainability Reporting Directive and Regulation (EU) 2020/852 as key drivers of ESG compliance.
- 97% rewrittenRisks Related to Regulations and Compliance
Health care reform measures could adversely affect our business
Added a specific reference to the OBBBA enacted in July 2025 reducing federal health care spending and imposing Medicaid restrictions.
- 89% rewrittenRisks Related to Our Intellectual Property
secure licenses from others on acceptable terms
Streamlined language regarding patent application prosecution and the dependence of patent protection scope.
Was: secure any necessary licenses from others on acceptable terms
- 83% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Any 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
Expanded restructuring risks to warn of future headcount reductions and potential difficulties in employee retention.
Was: Our 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
- 67% rewrittenRisks Related to Investment in Our Securities
Our stock price could be volatile, which could cause shareholders to lose part or all of their investment
Updated stock price volatility risk text to reference changing interest rates instead of rising interest rates.
- 66% rewrittenRisks Related to Our Business
Despite our increasingly diversified client base, we have historically depended on a limited number of customers for a high percentage of our revenues
Clarified that we currently do not have any customers representing more than 10% of consolidated revenues.
- 65% rewrittenRisks Related to Product Development, Strategic Investments, Collaborations and Acquisitions
If intangible assets and goodwill that we recorded in connection with our acquisitions become impaired, we may have to take significant charges against earnings
Retained core language on impairment of intangible assets and goodwill from acquisitions.
- 60% rewrittenRisks Related to Our Intellectual Property
If we are unable to obtain or maintain our intellectual property, we may not be able to succeed commercially
Revised intellectual property text to emphasize strategic global patent protection and trade secret importance.
- 55% rewrittenRisks Related to Data and Privacy
The use of new and evolving technologies, such as artificial intelligence (“AI”), in our offerings may present risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data
- 44% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Our results of operations could be negatively affected by potential fluctuations in foreign currency exchange rates
- 35% rewrittenRisks Related to Data and Privacy
Changes in laws and regulations governing the privacy and protection of data and personal information could adversely affect our business
- 35% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Our business, financial condition and results from operations could be adversely affected by disruptions in the global economy caused by geopolitical events, such as the ongoing conflicts between Russia and Ukraine and Israel and Palestine
All 49 risk factors
Headings as the filing states them, in filing order.
Other
- 01Investors should carefully consider the risk factors described below before making an investment decision
Risks Related to Our Business
- 02The bioprocessing market is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants
- 03If we are unable to continue to hire and retain skilled personnel, then we will have trouble developing and marketing our products
- 04Despite our increasingly diversified client base, we have historically depended on a limited number of customers for a high percentage of our revenues66% rewritten
Risks Related to Product Development, Strategic Investments, Collaborations and Acquisitions
- 05If we are unable to expand our product portfolio, our ability to generate revenue could be adversely affected
- 06Our acquisitions expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies
- 07risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property
- 08If intangible assets and goodwill that we recorded in connection with our acquisitions become impaired, we may have to take significant charges against earnings65% rewritten
- 09Intellectual 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 arrangementsNew
- 10Termination 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 streamsNew
Risks Related to Manufacturing and Supply
- 11If we are unable to manufacture our products in sufficient quantities and in a timely manner, our operating results will be harmed, our ability to generate revenue could be diminished and our gross margin may be negatively impacted
- 12We rely on a limited number of suppliers or, for certain of our products, one supplier, and we may not be able to find replacements or immediately transition to alternative suppliers, which could have a material adverse effect on our financial condition, results of operations and reputation
Risks Related to Our Financial Position and Need for Additional Capital
- 13place us at a disadvantage compared to our competitors who have less debt; and
- 14limit our ability to borrow additional amounts for working capital and other general corporate purposes, including to fund possible acquisitions of, or investments in, complementary businesses, products, services and technologies
- 15The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and liquidity
- 16Future strategic transactions or acquisitions may require us to seek additional financing, which we may not be able to secure on favorable terms, if at all
- 17Any 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 business83% rewritten
- 18Our exposure to political, economic and other risks that arise from operating a multinational business has and may continue to increase
- 19being subject to longer payment cycles from customers and experiencing greater difficulties in timely accounts receivable collections; and
- 20Our business success depends in part on our ability to anticipate and effectively manage these and other related factors. We cannot assure you that these and other related factors will not materially adversely affect our international operations or business as a whole
- 21We may be unable to efficiently manage our growth as a larger and more geographically expansive organization
- 22Our results of operations could be negatively affected by potential fluctuations in foreign currency exchange rates44% rewritten
- 23Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of products, which could negatively affect our operations and performance
- 24Our business, financial condition and results from operations could be adversely affected by disruptions in the global economy caused by geopolitical events, such as the ongoing conflicts between Russia and Ukraine and Israel and Palestine35% rewritten
Risks Related to Investment in Our Securities
- 25Our operating results may fluctuate significantly, our customers’ future purchases are difficult to predict and any failure to meet financial expectations may result in a decline in our stock price
- 26Securities or industry analysts may not publish favorable research or reports about our business or may publish no information, which could cause our stock price or trading volume to decline
- 27Our stock price could be volatile, which could cause shareholders to lose part or all of their investment67% rewritten
- 28Effective internal controls are necessary to provide reliable financial reports and to assist in the effective prevention of fraud. AnyNew
- 29Management 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)New
- 30Irrespective 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 thresholdNew
- 31Upon identifying the revenue recognition material weakness described above, we amended and restated certain items in our QuarterlyNew
Risks Related to Our Charter and Bylaws
- 32Anti-takeover provisions in our charter documents, certain of our contracts with third parties, and under Delaware law could make an acquisition of us, even one that may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
Risks Related to Tax Matters
- 33The 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
Risks Related to Regulations and Compliance
- 34We are subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulations
- 35Our business is subject to a number of environmental risks
- 36Climate change, climate change-related regulation and sustainability concerns could adversely affect our businesses and the operations of our subsidiaries, and any actions we take or fail to take in response to such matters could damage our reputation99% rewritten
- 37If our ESG practices do not meet evolving investor, regulatory, or industry expectations, our reputation, investor confidence, andNew
- 38Health care reform measures could adversely affect our business97% rewritten
- 39We may be exposed to liabilities under the Foreign Corrupt Practices Act, and any determination that we violated the Foreign Corrupt Practices Act could have a material adverse effect on our business
- 40Changes in accounting standards and subjective assumptions, estimates, and judgments by management related to complex accounting matters could significantly affect our financial results or financial condition
Risks Related to Data and Privacy
- 41Despite the implementation of security measures, our internal computer systems and those of our customers, collaborators cloud-basedNew
- 42Changes in laws and regulations governing the privacy and protection of data and personal information could adversely affect our business35% rewritten
- 43The use of new and evolving technologies, such as artificial intelligence (“AI”), in our offerings may present risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data55% rewritten
Risks Related to Our Intellectual Property
- 44If we are unable to obtain or maintain our intellectual property, we may not be able to succeed commercially60% rewritten
- 45secure licenses from others on acceptable terms89% rewritten
- 46validity and enforceability of the patent claimsNew
- 47Our freedom to develop, manufacture or sell products may be challenged by others, and we may engage in litigation which, if we do not prevail, could harm our business, results of operations, financial condition, cash flow and future prospectsNew
- 48and result in loss of protectionNew
- 49We may initiate litigation or other proceedings against third parties who misappropriate trade secrets or otherwise breach confidentiality obligationsNew
Other Repligen 10-Ks
- FY2024 10-K risk factors46 risks
Repligen faces intense bioprocessing competition from major players like Danaher and Thermo Fisher. Growth relies heavily on acquisitions and new product development. International operations expose the company to currency fluctuations and geopolitical risks.
Filed Mar 14, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.