Bioventus (BVS) risk factors, FY2025 10-K

Risks Related to Our Financial Position

1. 01Our 2025 Credit Agreement contains financial and operating restrictions that could limit our access to credit. If we fail to comply with its financial or other covenants, we might be required to repay the indebtedness, which could harm our liquidity52% rewritten
2. 02In the absence of a waiver from our lenders, any failure by us to comply with these covenants might result in the declaration of an event of default, which could adversely affect our business, results of operations and financial position33% rewritten
3. 03We might require additional capital to fund our financial and operating obligations and support business growth24% rewritten
4. 04Failure to establish and maintain effective financial controls could cause us to have material weaknesses and financial misstatements due to error, which could adversely affect our business and stock price25% rewritten
5. 05We maintain our cash and cash equivalents at financial institutions, in accounts where the balance exceeds federally insured limits (“FDIC”)

Risks Related to Our Business

1. 06We are, and may in the future become, subject to various legal proceedings and claims that arise in or outside the ordinary course of business. In particular, we are a party to derivative shareholder litigation described under the heading “Legal Proceedings” belowNew
2. 07We are highly dependent on a limited number of products for revenue generation and profitability59% rewritten
3. 08Our long-term growth may be limited by our inability to develop, acquire and commercialize new products, line extensions or expanded indications
4. 09If we are unsuccessful in developing, acquiring and commercializing new products or enhancing our existing product offerings through line extensions and expanded indications across our current product portfolio, our long-term growth may be negatively affected
5. 10If we fail to properly manage growth or scale our business processes, systems, and data management, our business could suffer77% rewritten
6. 11Any failure by us to manage our growth effectively could adversely affect our ability to achieve our development and commercialization goalsNew
7. 12Future growth will also impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees. In addition, rapid and significant growth will place a strain on our administrative and operational infrastructure
8. 13Demand for our existing products and any new products, line extensions or expanded indications depends on the continued and future acceptance of our products by physicians, patients, third-party payers and others in the medical community
9. 14The reserves we use to estimate the amount of variable consideration for items such as rebate payments due to third-party payers may be insufficient to cover our contractual payment obligations to them, which could adversely affect our business, results of operations and financial conditionNew
10. 15We rely on a limited number of third-party manufacturers to manufacture certain of our products and critical components
11. 16Due to the implementation of processing and billing system changes by payers, we may experience unexpected increases in the volume of rebate claims we receive from payers with whom we contract, which could negatively impact our business and financial resultsNew
12. 17If we are unable to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize, the commercial success of these products may be severely hindered
13. 18If our facilities are damaged or become inoperable, we will be unable to continue to research, develop and manufacture our products and, as a result, our business, results of operations and financial condition may be adversely affected until we are able to secure a new facility35% rewritten
14. 19Our business may be adversely affected if consolidation in the healthcare industry leads to demand for price concessions or if a GPO, third-party payer or other similar entities exclude us from being a supplier
15. 20We may be unable to complete proposed acquisitions or to successfully integrate proposed or recent acquisitions in a cost-effective and non-disruptive manner
16. 21We may not realize the anticipated strategic or financial benefits from our business divestitures, which may adversely affect our results of operations and financial condition49% rewritten
17. 22Pricing pressure from our competitors or hospitals may affect our ability to sell our products at prices necessary to support our current business strategies
18. 23If we fail to successfully enter into purchasing contracts for our Surgical Solutions products or engage in contract bidding processes internationally, we may not be able to receive access to certain hospital facilities and our sales may decrease
19. 24Governments outside the United States may not provide coverage or reimbursement of our products, which may adversely affect our international expansion plans and harm our business, results of operations and financial condition
20. 25Our future growth depends on physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products
21. 26The proposed down-classification of non-invasive bone growth stimulators, including EXOGEN, by the FDA could increase future competition for bone growth stimulators and otherwise adversely affect our sales of EXOGEN
22. 27We compete and may compete in the future against other companies, some of which have longer operating histories, more established products or greater resources than we do, which may prevent us from achieving increased market penetration or improved operating results
23. 28The reclassification of our HA products from medical devices to drugs in the United States by the FDA could negatively impact our ability to market these products and may require that we conduct costly additional clinical studies to support current or future indications for use of those products
24. 29Our ability to maintain our competitive position and to execute our strategic plans depends on our ability to attract, retain and motivate our senior management team and other highly qualified personnel, and our failure to do so could adversely affect our business, results of operations and financial condition
25. 30We may not be able to strengthen our brand and the brands associated with our products
26. 31We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance
27. 32Fluctuations in the demand for our products or our inability to forecast demand accurately may influence the ability of our suppliers to meet our delivery needs or result in excess product inventory
28. 33We may face issues with respect to the supply of our products or their components, including increased costs, disruptions of supply, shortages, contamination or mislabeling
29. 34If we fail to maintain our numerous contractual relationships, our business, results of operations and financial condition could be adversely affected
30. 35Failure of a key information technology and communication system, process or site could adversely affect our business, results of operations and financial condition
31. 36Our business subjects us to economic, political, regulatory and other risks associated with international sales and operations that could adversely affect our business, results of operations and financial condition27% rewritten
32. 37We are exposed to foreign currency risks, which may adversely affect our business, results of operations and financial condition
33. 38International tariffs, including tariffs applied to goods traded between the United States and other countries, and restrictions on goods imported from certain such regions may adversely affect our business, results of operations and financial condition73% rewritten

Risks Related to Government Regulation

1. 39Our products and operations are subject to extensive governmental regulation, and our failure to comply with applicable requirements could cause our business to suffer
2. 40The regulations to which we are subject are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales
3. 41Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and harm our reputation, business, results of operations and financial condition
4. 42We may be subject to enforcement action if we engage in improper claims submission practices and resulting audits or denials of our claims by government agencies could reduce our net sales or profits and could lead to significant civil or criminal penalties and other liability
5. 43The FDA regulatory process is expensive, time-consuming and uncertain, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products
6. 44Any of these sanctions could also result in higher than anticipated costs or lower than anticipated sales and adversely affect our business, results of operations and financial condition
7. 45Our HCT/P products are subject to extensive government regulation and our failure to comply with these requirements could cause our business to suffer
8. 46If clinical studies of our future products do not produce results necessary to support regulatory clearance, approval or certification in the United States or elsewhere, we will be unable to expand the indications for or commercialize these products
9. 47Interim, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
10. 48Our products may cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could materially harm our business
11. 49We and our third-party manufacturers and suppliers are subject to various governmental regulations related to the manufacturing of our products
12. 50Various governmental reimbursement reform and other healthcare cost containment proposals may affect our ability to sell our products profitably and could adversely affect our business results and operations and financial conditionsNew
13. 51Our products may be subject to product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could adversely affect us
14. 52We may rely on third parties to conduct our clinical studies and to assist us with preclinical development, and if they fail to perform as contractually required or expected, we may not be able to obtain regulatory clearance, approval or certification to commercialize our products
15. 53Healthcare regulatory reform may affect our ability to sell our products profitably and could adversely affect our business, results of operations and financial condition53% rewritten
16. 54We are subject to federal, state and foreign laws and regulations relating to our healthcare business, and could face substantial penalties if we are determined not to have fully complied with such laws, which would adversely affect our business, results of operations and financial condition
17. 55Failure to comply with the FCPA and laws associated with our activities outside the United States could adversely affect our business, results of operations and financial condition
18. 56If we fail to meet Medicare accreditation and surety bond requirements or DMEPOS supplier standards, it could adversely affect our business, results of operations and financial condition
19. 57Our operations involve the use of hazardous and toxic materials, and we must comply with environmental, health and safety laws and regulations, which can be expensive, and could adversely affect our business, results of operations and financial condition
20. 58Our employees, independent distributors, independent contractors, suppliers and other third parties may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could expose us to liability and hurt our reputation
21. 59We may be subject to environmental, social and governance (“ESG”) regulations or stakeholder requirements which may negatively impact our business or adversely affect our relationship with customers
22. 60Recent environmental regulatory actions regarding medical device sterilization facilities could result in disruptions in the supply of certain of our products and could adversely affect our business, results of operations and financial condition

Risks Related to Intellectual Property Matters

1. 61Protection of our intellectual property rights may be difficult and costly, and our inability to protect our intellectual property could adversely affect our competitive position
2. 62Trade Secrets and Know-How
3. 63Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology
4. 64We may in the future be a party to patent and other intellectual property litigation and administrative proceedings that could be costly and could interfere with our ability to successfully market our products
5. 65We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or former employers or are in breach of non-competition or non-solicitation agreements with our competitors or former employers
6. 66Any product candidates that we develop as biologics subject to the BLA pathway may be subject to competition sooner than anticipated
7. 67Intellectual property rights do not necessarily address all potential threats to our business

Risks Related to Our Organizational Structure and the Tax Receivable Agreement

1. 68Our principal asset is our interest in BV LLC, and, accordingly, we depend on distributions from BV LLC to pay our taxes and expenses, including payments under the Tax Receivable Agreement. BV LLC’s ability to make such distributions may be subject to various limitations and restrictions
2. 69The TRA with the Continuing LLC Owner requires us to make cash payments to it in respect of certain tax benefits to which we are or may become entitled, and we expect that the payments we will be required to make could be significant
3. 70In certain cases, payments under the TRA to the Continuing LLC Owner may be accelerated or significantly exceed the actual benefits we realize in respect of the tax attributes subject to the TRA
4. 71We may make payments to the Continuing LLC Owner under the TRA that exceed the tax benefits actually realized by us in the event that any tax benefits are disallowed by a taxing authority
5. 72Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our results of operations and financial condition
6. 73Bioventus is controlled by the Original LLC Owners, whose interests may differ from those of our public stockholders

Risks Related to Ownership of Our Class A Common Stock

1. 74The dilution of our Class A common stockholders upon the exchange of the outstanding common membership interests in BV LLC could adversely affect the market price of our Class A common stock and the resale of such shares could cause the market price of our Class A common stock to fall
2. 75Our stock price may be volatile or may decline regardless of our operating performance, and you may not be able to resell your shares of Class A common stock at or above the price at which you purchase them
3. 76Our amended and restated certificate of incorporation, as amended, to the extent permitted by applicable law, contains provisions renouncing our interest and expectation to participate in certain corporate opportunities identified or presented to certain of our Original LLC Owners
4. 77Certain anti-takeover provisions in our governing documents and under Delaware law could make an acquisition of our Company more difficult, limit attempts by our stockholders to replace or remove our current management, and depress the market price of our common stock
5. 78We are an emerging growth company and we cannot be certain if the reduced disclosure requirements applicable to us will make our Class A common stock less attractive to investors26% rewritten
6. 79Beginning with our Annual Report on Form 10-K for the year ending December 31, 2026, we will no longer be able to take advantage of reduced reporting requirements applicable to emerging growth companies, which will require us to incur significant expenses and expend time and resourcesNew