Organogenesis Holdings (ORGO) risk factors, FY2025 10-K

Risks Related to Organogenesis and its business

1. 01Our operating results may fluctuate significantly as a result of a variety of factors, many of which are outside of our control
2. 02Rapid technological change could cause our products to become obsolete, and if we do not enhance our product offerings through our research and development efforts, we may be unable to effectively compete
3. 03compete successfully against other skin substitutes and other modalities for treating wounds such as negative-pressure wound therapy and hyperbaric oxygen
4. 04To be commercially successful, we must convince physicians that our products are safe and effective alternatives to existing treatments and that our products should be used in their procedures
5. 05We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance
6. 06Interruptions in the supply of our products or inventory loss may adversely affect our business, results of operations, and financial condition
7. 07Our products are dependent on the availability of tissue from human donors, and any disruption in supply could adversely affect our business, results of operations, and financial condition
8. 08Increased prices for, or unavailability of, raw materials used in our products could adversely affect our business, results of operations, and financial condition
9. 09We may invest significant capital to maximize our sales and marketing infrastructure, and there can be no assurance that these efforts will result in significant increases in sales
10. 10We will need to continue to expand our organization, and managing growth may be more difficult than expected
11. 11We may expand our business through acquisitions, licenses, investments, and other commercial arrangements in other companies or technologies. Such acquisitions or commercial arrangements may entail significant risks
12. 12New lines of business or new products and services may subject us to additional risks
13. 13Significant disruptions of information technology systems or breaches of information security could adversely affect our business, results of operations, and financial condition
14. 14If a breach of our measures protecting personal data covered by HIPAA, the HITECH Act, or the CCPA occurs, we may incur significant liabilities
15. 15We engage in transactions with related parties and such transactions present possible conflicts of interest that could have an adverse effect on our business, results of operations, and financial condition
16. 16our executive officers and directors that hold positions of responsibility with related parties may have significant duties with, and spend significant time serving, other entities and may have conflicts of interest in allocating time
17. 17We incurred non-cash impairment and write-down charges during 2025 and 2024 which adversely affected our fiscal year 2025 and 2024 operating results and we may be required to incur additional future impairment and write-down charges, which could adversely affect our operating results42% rewritten
18. 18We may be required to record a significant charge to earnings if our goodwill and other amortizable intangible assets, or other assets become impaired32% rewritten
19. 19Our ability to use our net operating loss carryforwards may be subject to certain limitations79% rewritten
20. 20our operating loss and credit carryforwards, though we are already subject to limitations in net operating loss utilization in certain states
21. 21Effective internal controls are necessary for us to provide reliable financial reports and operate successfully as a public company. Section 404 of the Sarbanes-Oxley Act of 2002 (“SOX”) requires that companies evaluate and report on their systems of internal control over financial reporting

Risks Related to Regulation of Our Products and Other Government Regulations

1. 22We may encounter substantial delays or difficulties in our clinical trials
2. 23ReNu is in Phase 3 clinical development for the management of symptoms associated with knee OA. Our anticipated timeline for these and other trials and studies on our clinical trial candidates may be subject to delays due to factors such as those discussed above25% rewritten
3. 24verification procedures that may result in the final data being materially different from such preliminary, initial or interim data. As a result, preliminary, initial or interim data should be considered carefully and with caution until the final data are availableNew
4. 25Obtaining the necessary regulatory approvals or clearances for certain of our products will be expensive and time-consuming and may impede our ability to fully exploit our technologies or otherwise limit our ability to meet other business objectives
5. 26Regenerative medicine advanced therapy, or RMAT, designation for our product candidates may not lead to faster development or regulatory processes nor does it increase the likelihood that such product candidates will receive marketing approval
6. 27We may seek fast track designation by the FDA for one or more of our product candidates, but we might not receive such designation, and even if we do, such designation may not actually lead to a faster development or regulatory review or approval process
7. 28A breakthrough therapy designation by the FDA for a product candidate may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that the product candidate will receive marketing approval60% rewritten
8. 29We must comply with applicable post-marketing regulatory obligations, which could include obtaining new regulatory approvals or clearances92% rewritten
9. 30require such premarket approval or clearance, which would disrupt the marketing of these products, potentially expose us to regulatory sanctions, and have a material adverse effect on our business, financial condition and results of operationsNew
10. 31expensive, expansion of our tissue product offerings could be significantly delayed, and we could be subject to additional post-market regulatory requirements or suspension of product sales until FDA approval is obtainedNew
11. 32Our business is subject to continuing and evolving significant regulatory obligations by the FDA and other authorities, compliance with which is expensive and time-consuming and may impede our ability to fully exploit our technologies or otherwise limit our ability to meet other business objectives
12. 33Many of the products we manufacture and process are derived from human tissue and therefore have the potential for disease transmission79% rewritten
13. 34We may implement a product recall or voluntary market withdrawal, which could significantly increase our costs, damage our reputation and disrupt our business
14. 35Both before and after a product is commercially released, we have ongoing responsibilities under regulations promulgated by the FDA, the Federal Trade Commission, and similar United States and foreign regulations governing product labeling and advertising, distribution, sale, and marketing of our products
15. 36Our operations are subject to various federal, state, and foreign fraud and abuse laws. These laws may constrain our operations, including the financial arrangements and relationships through which we market, sell, and distribute our products77% rewritten
16. 37We could be subject to legal exposure if we do not comply with our reporting and payment obligations under Medicare or any other governmental pricing programs in which our products or product candidates may participate, including through additional rebate or discount requirements, fines, sanctions, and litigationNew
17. 38Our sales into foreign markets expose us to risks associated with international sales and operations
18. 39We could be adversely affected by violations of the United States Foreign Corrupt Practices Act and similar worldwide anti-bribery laws

Risks Related to Reimbursement for our Products

1. 40Coverage policies and reimbursement rates for our products by government and private insurance are subject to change
2. 41our ability to access capital59% rewritten
3. 42Cost-containment efforts of our customers, purchasing groups, third-party payers, and governmental organizations could adversely affect our business, results of operations, and financial condition

Risks Related to Our Intellectual Property

1. 43Our patents and other intellectual property rights may not adequately protect our products
2. 44In addition, these patent rights may be challenged, revoked, invalidated, infringed, or circumvented by third parties. Laws relating to such rights may in the future be changed or withdrawn in a manner adverse to usNew
3. 45Pending and future intellectual property litigation could be costly and disruptive and may have an adverse effect on our business, results of operations, and financial condition
4. 46We may be subject to damages resulting from claims that we, our employees, or our independent contractors have wrongfully used or disclosed alleged trade secrets, proprietary or confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors
5. 47We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming, and ultimately unsuccessful
6. 48If we are unable to protect the confidentiality of our trade secrets and know-how, our business and competitive position would be harmed
7. 49We may be subject to claims challenging the inventorship or ownership of the patents and other intellectual property that we own or license
8. 50Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
9. 51Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our products

Risks Related to Our Series A Preferred Stock

1. 52The Investors may exercise influence over us, including through their ability to designate, and the ability of the holders of Convertible Preferred Stock to elect, a member of our board of directors22% rewritten
2. 53the entry into, or amendment or waiver of, any agreement by us (including our subsidiaries) that would prevent or delay us from complying, or impair our ability to comply, with our obligations to make the Cash-in-Lieu Payments33% rewritten

Risks Related to Our Class A Common Stock

1. 54The concentration of ownership of our capital stock limits your ability to influence corporate mattersNew
2. 55Our stock price has been, and is likely to continue to be, volatile. Fluctuations in revenue or results of operations could cause additional volatility in our stock price and thus our stockholders could incur substantial losses
3. 56any action to interpret, apply, enforce or determine the validity of the certificate of incorporation or the bylaws; or
4. 57Provisions in the Company’s charter may inhibit a takeover of the Company, which could limit the price investors might be willing to pay in the future for the Company's Class A common stock and could entrench management
5. 58We have previously been, and may in the future be, subject to securities class action litigation or other litigation that could cause us to incur significant legal expenses, divert management’s attention, and result in harm to our business
6. 59We face significant and continuing competition, which could adversely affect our business, results of operations, and financial condition
7. 60Our future capital needs are uncertain and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all
8. 61unanticipated general, legal, and administrative expenses
9. 62Our future success depends on our ability to retain key employees, consultants and advisors, and to attract, retain and motivate qualified personnel
10. 63Uncertainty and adverse changes in the general economic conditions, including turmoil in the global banking system, may negatively affect our business
11. 64Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect our business, results of operations, and financial condition
12. 65Our failure to comply with regulatory obligations could result in negative effects on our business
13. 66requiring changes in our advertising and promotion practices
14. 67Our officers, employees, independent contractors, principal investigators, consultants and commercial partners may engage in misconduct or activities that are improper under other laws and regulations, which would create liability for us
15. 68manufacturing standards we have established
16. 69If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business, results of operations, and financial condition
17. 70Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of the Company’s income or other tax returns could adversely affect the Company’s financial condition and results of operations
18. 71lower than anticipated future earnings in jurisdictions where the Company has lower statutory tax rates and higher than anticipated future earnings in jurisdictions where the Company has higher statutory tax rates
19. 72A market for the Company’s securities may not continue, which would adversely affect the liquidity and price of the Company’s securities
20. 73The Company’s quarterly operating results may fluctuate significantly and could fall below the expectations of securities analysts and investors due to seasonality and other factors, some of which are beyond the Company’s control, resulting in a decline in the Company’s stock price
21. 74If securities or industry analysts do not publish or cease publishing research or reports about the Company, its business, or its market, or if they change their recommendations regarding the Company Class A common stock adversely, then the price and trading volume of the Company Class A common stock could decline
22. 75Changes in laws, regulations or rules, or a failure to comply with any laws, regulations or rules, may adversely affect the Company’s business, investments and results of operations
23. 76Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our securities
24. 77Changes to trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect on our reputation, business, financial condition and results of operations