What changed in this filing

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Item 1A. Risk Factors

2026-07-14 compared with 2025-07-18 · 58 added, 37 removed, 405 unchanged (19% of the section changed)

6 unchanged sentences

We may be unable to compete effectively with respect to technological innovation and price which may have a material adverse effect on our revenues, financial condition, results of operations and/or liquidity.

The markets for our products are highly competitive and we expect competition to continue to intensify.

The markets for our products are highly competitive and we expect competition to continue to intensify, in part due to the trend of increased consolidation, which may result in companies with greater scale and market power.

The medical device industry is characterized by rapid technological change, frequent product introductions and evolving customer requirements.

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Our competitors may also develop products and technologies that are superior to ours or that otherwise could render our products obsolete or noncompetitive.

The trend of increased consolidation in the medical technology industry has resulted in companies with greater scale and market power, intensifying competition and increasing pricing pressure.

We may also face competition from providers of other medical therapies, such as pharmaceutical companies, that may offer non-surgical therapies for conditions that are currently, or in the future may be, treated using our products.

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Product life cycles are relatively short because medical device manufacturers continually develop more effective and less expensive versions of existing devices in response to physician demand.

We engage in product development and improvement programs to maintain and improve our competitive position.

Our products are technologically complex and these programs involve significant planning, market studies, investment in research and development, clinical trials and regulatory clearances or approvals and may require more time and expense than anticipated to bring such products to market.

Our products are technologically complex and we engage in significant product development and improvement programs to maintain and improve our competitive position, including market studies and clinical trials that may require more time and expense than anticipated.

We may not, however, be successful in enhancing existing products, or developing new products or technologies that will achieve regulatory approval, be developed or manufactured in a cost-effective manner, obtain appropriate intellectual property protection or receive market acceptance.

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If the results of these trials are not what we expect or fail to generate meaningful clinical data, it may adversely impact our ability to obtain product approvals.

any of these products fail to achieve clinical acceptance or are perceived unfavorably by the market, it could severely limit our ability to drive revenue growth, which could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.

If any of these products fail to achieve clinical acceptance or are perceived unfavorably by the market, it could severely limit our

ability to drive revenue growth, which could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.

As part of our business strategy, we expect to continue to engage in business development activities which includes selectively evaluating and pursuing the acquisition of complementary businesses, technologies and products.

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We currently purchase significant amounts of several key products, raw materials and product components from single and limited source suppliers and anticipate that we will do so for future products as well.

Any delays in delivery of or shortages in those or other products and components (like we experienced during our 2022 and 2023 fiscal year) could interrupt and delay manufacturing of our products, lead to backlogs and result in the cancellation of orders for our products.

Any delays in delivery of or shortages in those or other products and components could interrupt and delay manufacturing of our products, lead to backlogs and result in the cancellation of orders for our products.

Any or all of these suppliers could discontinue the manufacture or supply of these products, raw materials and/or components at any time.

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We also announced a plan to transfer certain product manufacturing processes from Queensbury, NY to third-party manufacturers located in various parts of the world, including, but not limited to the United States, Costa Rica, Latvia, Italy, Israel and China.

The restructuring activities associated with this plan are expected to be completed in the third quarter of fiscal year 2026.

The restructuring activities associated with this plan are expected to be completed in the first quarter of fiscal year 2027.

If we are unable to effectively execute on this plan within the announced timeline it could have a material adverse effect on our business, financial condition and/or results of operations.

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In addition, our business practices in international markets are subject to the requirements of the U.S.

Foreign Corrupt Practices Act of 1977, as amended, any violation of which could subject us to significant fines, criminal sanctions and other penalties.

We expect all of our contracted manufacturing facilities, to comply with all applicable laws, including labor, safety and environmental laws, and to otherwise meet our standards of conduct.

Foreign Corrupt Practices Act of 1977, as amended (the "FCPA"), any violation of which could subject us to significant fines, criminal sanctions and other penalties.

We expect all of our contracted manufacturing facilities, to comply with all applicable laws and to otherwise meet our standards of conduct.

Our ability to find manufacturing facilities that uphold these standards is a challenge, especially with respect to facilities located outside the United States.

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In the event we are unable to increase our prices or find alternative manufacturing capacity or relocate to an alternative base of operation outside of China on favorable terms, we would likely experience higher manufacturing costs and lower gross margins, which could have an adverse effect on our business and results of operations.

The Chinese economy differs from the economies of most developed countries in many respects, including the degree of government involvement, the level of development, the growth rate, the control of foreign exchange, access to financing and the allocation of resources.

We are heavily dependent on third-party distributors to generate a substantial portion of our international revenues and are at the risk of these distributors also selling for our competitors, failing to be financially viable and failing to effectively distribute our products in compliance with applicable laws.

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International distributors accounted for approximately 75% of international revenues for the fiscal year ended May 31, 2026.

International sales decreased 21% in fiscal year 2025 partially due to the sale of the PICCs, Midline, dialysis and BioSentry businesses, along with the discontinuation of the RadioFrequency Ablation product line.

International sales increased 9% in fiscal year 2026 partially due to the sale of the PICCs, Midline, dialysis and BioSentry businesses, along with the discontinuation of the RadioFrequency Ablation product line.

If we are unable to maintain our relationships or establish direct sales capabilities on acceptable terms or at all, we may lose significant revenue or be unable to achieve our growth aspirations.

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Our products are used in medical procedures and purchased principally by hospitals or physicians which typically bill various third-party payors, such as governmental programs (e.g., Medicare, Medicaid and comparable foreign programs), private insurance plans and managed care plans, for the healthcare services provided to their patients.

Worldwide initiatives to contain healthcare costs have led governments and the private sector to enact cost containment efforts as a means of managing the growth of health care utilization.

Worldwide initiatives to contain healthcare costs have led governments and the private sector to enact cost containment efforts as a means of managing

the growth of health care utilization.

Common techniques include policies on price regulation, competitive pricing, bidding and tender mechanics, coverage and payment, comparative effectiveness of therapies, technology assessments, and managed-care arrangements.

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The ability of our customers to obtain appropriate reimbursement for products and services from third-party payors is critical to the success of medical device companies because it affects which products customers purchase and the prices they are willing to pay.

In general, a third-party payor only covers a medical product or procedure when the plan administrator is satisfied that the product or procedure improves health outcomes, including quality of life or functional ability, in a safe and cost-effective manner.

Even if a device has received clearance or approval for marketing by the FDA, there is no assurance that third-party payors, including Medicare and managed care companies, will cover the cost of the device and related procedures.

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The design, manufacture and marketing of the types of medical devices we sell entail an inherent risk of product liability.

Our products are used by physicians to treat seriously ill patients.

We are periodically subject to product liability claims, and patients or customers may in the future bring claims against us in a number of circumstances and for a number of reasons, including if our products were misused, if a component of our product fails, if our manufacture or design was flawed, if the product produced unsatisfactory results or if the instructions for use and operating manuals and disclosure of product related risks for our products were found to be inadequate.

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The outcome of litigation, particularly class action and multidistrict litigation, is difficult to assess or quantify.

Plaintiffs in these types of lawsuits often seek recovery of very large or indeterminate amounts, including not only actual damages, but also punitive damages.

Plaintiffs in these types of lawsuits often

seek recovery of very large or indeterminate amounts, including not only actual damages, but also punitive damages.

The magnitude of the potential losses relating to these lawsuits may remain unknown for substantial periods of time.

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We may be exposed to risks associated with product line divestitures as we may never realize the expected benefits and could cause operational disruptions with personnel, systems and infrastructure changes.

The Company's recent divestitures of its PICCs and Midline businesses to Spectrum Vascular and dialysis product portfolio and BioSentry tract sealant system biopsy business to Merit Medical Systems, Inc., along with potential future divestitures of certain product lines will allow us to transform ourselves into a high growth, highly profitable, medical technology company.

The Company's recent divestitures of certain product lines, along with potential future divestitures of certain other product lines will allow us to transform ourselves into a high growth, highly profitable, medical technology company.

If we are unable to achieve our growth and profitability objectives due to competition, lack of acceptance of our products, failure to generate favorable clinical data or gain regulatory approvals, or other risks as described in this section, or due to other events, we will not be successful in transforming our business and may not see the appropriate market valuation.

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Recently, the costs of labor, raw materials, transportation, construction, services, and energy necessary for the production and distribution of our products have increased significantly.

While we have implemented cost containment

measures, selective price increases and taken other actions to offset these inflationary pressures in our supply chain, we may not be able to completely offset all the increases in our operational costs, any of which could adversely affect our business, financial condition, results of operations and/or liquidity.

While we have implemented cost containment measures, selective price increases and taken other actions to offset these inflationary pressures in our supply chain, we may not be able to completely offset all the increases in our operational costs, any of which could adversely affect our business, financial condition, results of operations and/or liquidity.

Sales outside the U.S.

accounted for approximately 14% of our net sales during our fiscal year ended May 31, 2026.

We anticipate that sales from international operations will continue to represent a significant portion of our total sales, and we intend to continue our expansion into emerging and/or faster-growing markets outside the U.S.

We anticipate that sales from international operations will continue to represent a significant portion of our total sales, and we

intend to continue our expansion into emerging and/or faster-growing markets outside the U.S.

Our sales and profitability from our international operations are subject to risks and uncertainties that could have a material adverse effect on our business, financial condition and/or results of operations, many of which we cannot predict, including:

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and European leaders.

The Israel/Hamas war has also disrupted operations of companies doing business in the Middle East.

The Israel/Hamas war and the military conflict involving Iran and the associated geopolitical tensions in the Middle East have also disrupted operations of companies doing business in the Middle East.

These events may escalate and have created increasingly volatile global economic conditions.

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Further, actions we take to adapt to new tariffs or trade restrictions may cause us to modify our operations or forgo business opportunities, which could have a material adverse impact on our business, financial condition, results of operations and/or liquidity.

Our business could be harmed if we cannot hire or retain qualified personnel.

Our business could be harmed if we cannot hire or retain qualified personnel or fail to successfully manage the transition to a new Chief Executive Officer.

Our business depends upon our ability to attract and retain highly qualified personnel, including managerial, sales, and technical personnel.

We compete for key personnel with other companies, healthcare institutions, academic institutions, government entities and other organizations.

We do not have written employment agreements with our executive officers, other than the CEO.

We do not have written employment agreements with our executive officers, other than the Chief Executive Officer ("CEO").

Our ability to maintain and expand our business may be impaired if we are unable to retain our current key personnel or hire or retain other qualified personnel in the future, including personnel for our manufacturing facilities and field based sales employees.

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In addition, our sales force is highly talented and we face intense competition in our industry for sales personnel which could have an adverse effect on our business and revenue if there is significant turnover.

Additionally, certain of our officers, including our CEO, have significant tenure with the Company, are highly knowledgeable of the Company’s business and operations, maintain key external relationships on behalf of the Company, and

have been integral to the success of the Company.

Significant resources and attention may need to be expended at the executive and Board levels to identify and onboard successors in the event of an unexpected or unplanned departure of any such officers.

As previously disclosed, our President and CEO, James C.

Clemmer, has announced his intention to retire on the earlier of November 30, 2026 and appointment of a successor CEO, and our Board has initiated a search for a new CEO.

CEO transitions can be inherently difficult to manage.

During this succession and transition period, there could be uncertainty among investors, customers, third parties and employees concerning our future leadership, which could negatively impact our operating results and may cause disruption to the Company’s business.

We may not be able to employ a suitable replacement CEO at favorable terms in the near future, or at all.

If we do identify and appoint a suitable successor CEO, the effectiveness of our new CEO, and our ability to maintain continuity during the transition, could have a material adverse impact on our business, financial condition or results of operations.

If we are unable to manage our growth profitably, our business, financial results and stock price could suffer.

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In recent years we have begun to implement operational excellence initiatives which include a number of restructuring, realignment and cost reduction initiatives.

We may not realize the benefits of these initiatives to the extent or on the timing we anticipated and the ongoing difficulties in implementing these measures may be greater than anticipated and/or offset by inflationary pressures, which could cause us to incur additional costs or result in business disruptions like the backlog we experienced in fiscal year 2023.

In addition, if these measures are not successful or sustainable, we may undertake additional realignment and cost reduction efforts, which could result in significant additional expenses and adversely impact our ability to achieve our other strategic goals and business plans.

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The covenants could also restrict our flexibility in planning for changes in our business and the industry and could make us more vulnerable to economic downturns and adverse developments, could limit our flexibility in planning for, or reacting to, changes and opportunities in the markets in which we compete, could place us at a competitive disadvantage compared to our competitors that have less debt or could require us to dedicate a substantial portion of our cash flow to service our debt.

Our ability to meet our cash requirements could be dependent upon our operating performance, which would be subject to general economic and competitive conditions and to financial, business and other factors affecting our operations, many of which could be beyond our control.

Our ability to meet our cash requirements could be dependent upon our operating performance, which would be subject to many factors which could be beyond our control.

We cannot provide assurance that our business operations would generate sufficient cash flows from operations to fund potential cash requirements and debt service obligations.

6 unchanged sentences

A significant deterioration in economic conditions, including economic slowdowns or recessions, increased unemployment levels, inflationary pressures or disruptions to credit and capital markets, could lead to decreased consumer confidence and spending and availability of credit.

For example, a rapid increase in inflation levels may negatively impact demand for our products and increase our costs and may lead to a rapid increase in market interest rates.

For example, a rapid increase in inflation levels may negatively impact demand for our products and increase our costs and may lead to a rapid increase in interest rates.

In addition, if rates increase, we may incur significant additional expense and adversely impact our ability to achieve our other strategic goals and business plans.

Economic uncertainty, an increase in unemployment rates, as well as an increase in health insurance premiums, co-payments and deductibles may result in cost-conscious consumers making fewer trips to their physicians and specialists or deferring or foregoing elective surgeries and other non-critical medical procedures, which in turn would adversely affect demand for our products.

Additionally, recent macroeconomic events, including inflationary pressures and threatened and imposed tariffs have negatively impacted consumer sentiment, resulted in decreased procedural volume for certain treatments, especially in the United States, and have impacted our customer's liquidity and purchasing behaviors.

If these or similar conditions persist or worsen, our business, financial condition and results of operations could be materially harmed.

Our intangible assets and fixed assets are subject to potential impairment;

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Similar to other large multi-national companies, the size and complexity of our information technology systems makes them vulnerable to cyber-attacks, malicious intrusions, breakdowns, destruction, losses of data privacy, or other significant disruptions.

Our distributors and supply chain partners face similar risks.

Our information systems require an ongoing commitment of resources to maintain, protect, and enhance existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving systems and regulatory standards, the increasing need to protect patient and customer information, and changing customer patterns.

evolving systems and regulatory standards, the increasing need to protect patient and customer information, and changing customer patterns.

In addition, third parties may attempt to gain access into our systems or products or those of our supply chain partners to obtain data relating to patients or our proprietary information.

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Artificial intelligence, or AI, based platforms are increasingly being used in the medical device and consumer health industries.

We are committed to providing a safe and secure environment for all of our personnel, our business partners and our

customers, including the responsible use of AI chatbots and generative AI data processor products (“AI Systems”).

We are committed to providing a safe and secure environment for all of our personnel, our business partners and our customers, including the responsible use of AI chatbots and generative AI data processor products (“AI Systems”).

We have developed policies governing the use of AI Systems to help reasonably ensure that such AI Systems are used in a trustworthy manner by our employees, contractors and authorized agents and that AngioDynamics’ assets, including intellectual property, competitive information, personal information and customer information, are protected.

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Our amended and restated certificate of incorporation and our amended and restated bylaws contain provisions that may enable our management to resist a change in control.

For example, our Board of Directors is classified so that not all members of our Board of Directors are elected at one time and our Board of Directors is authorized, without prior stockholder approval, to create and issue “blank check” preferred stock with rights senior to those of our common stock and stockholder action by written consent is prohibited.

written consent is prohibited.

We are also subject to the provisions of Section 203 of the Delaware General Corporation Law, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock.

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Such risks may also have the effect of heightening other risks described herein, such as those relating to general economic conditions, demand for our products, relationships with suppliers and sales efforts.

For example, impacts from the COVID-19 pandemic and measures taken in response thereto, such as constraints in the capacities of hospitals and other healthcare providers to perform non-COVID related procedures, changes to our on-site operations, delays in product development efforts and related clinical trials and regulatory clearances and approvals, and disruptions to global supply chains and labor markets, resulting in cost inflation and raw material supply constraints, adversely affected our business and there can be no assurance that similar events will not occur in the future.

For example, impacts from the COVID-19 pandemic and measures taken in response thereto, adversely affected our business and there can be no assurance that similar events will not occur in the future.

We could be negatively impacted by Environmental, Social and Governance (ESG), climate change and other sustainability-related matters .

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We are subject to a comprehensive system of federal, state and international laws and regulations, and we could be the subject of investigations, enforcement actions or face lawsuits and monetary or equitable judgments.

Foreign Corrupt Practices Act (“FCPA”) and similar anti-bribery laws in international jurisdictions, including the UK Anti-Bribery Act, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), General Data Protection Regulation (“GDPR”), domestic and foreign data protection, data security and privacy laws, laws related to the collection, storage, use and disclosure of personal data and laws and regulations relating to sanctions and money laundering.

We operate in many parts of the world, and our operations are affected by complex state, federal and international laws relating to healthcare, environmental protection, antitrust, anti-corruption, anti-bribery, fraud and abuse, export control, tax, employment and laws regarding privacy, personally identifiable information and protected health information, including, for example, the Food, Drug and Cosmetic Act (“FDCA”), various FDA and international regulations relating to, among other things, the development, quality assurance, manufacturing, importation, distribution, marketing and sale of, and billing for, our products, the federal Anti-Kickback Statute and Federal False Claims Act (Note 17), the FCPA and similar anti-bribery laws in international jurisdictions, including the UK Anti-Bribery Act, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), General Data Protection Regulation (“GDPR”), domestic and foreign data protection, data security and privacy laws, laws related to the collection, storage, use and disclosure of personal data and laws and regulations relating to sanctions and money laundering.

The failure to comply with these laws and regulatory standards, allegations of such non-compliance or the discovery of previously unknown problems with a product or manufacturer:

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and (iv) could otherwise disrupt our business and could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.

On July 4, 2025, the One Big Beautiful Bill Act (the “OBBB Act”) was enacted, which makes a number of changes to U.S.

federal income tax law.

The law’s provisions include, but are not limited to, changes in corporate income tax rates and other business deductions, as well as changes to healthcare-related programs, including treatment of research and development

expenditures.

The effect of interpretive guidance on these and other provisions could have a material adverse effect on our business, financial condition, and results of operations.

We will continue to evaluate the impact of the OBBB Act as additional information and guidance becomes available.

The healthcare industry is under continued scrutiny from state, federal and international governments, including with respect to industry practices in the area of sales and marketing.

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This process usually takes from four to twelve months from the date the premarket notification is submitted to the FDA, but may take significantly longer.

The ability of the FDA, other agencies and notified bodies to review and authorize or certify for marketing new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, agency’s or notified body’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the agency’s or notified body’s ability to perform routine functions.

Even after a device receives regulatory approval it remains subject to significant regulatory and quality requirements, such as manufacturing, recordkeeping, renewal, recertification or reporting and other post market approval requirements, which may include clinical, laboratory or other studies.

Product approvals by the FDA and other foreign regulators can be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval or may be re-classified to a higher regulatory classification, such as requiring a PMA for a previously cleared 510(k) device.

The PMA process is much more costly, lengthy and uncertain.

The PMA process is much more costly, lengthy

and uncertain.

It generally takes from one to three years from the date the application is submitted to, and filed with the FDA, and may take even longer.

In addition, any modification to an FDA-cleared medical device that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, requires a new FDA 510(k) clearance or, possibly, a PMA.

In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA, other agencies and notified bodies may also slow the time necessary for new medical devices or modifications to be reviewed and/or cleared, approved or certified by necessary agencies or notified bodies, which would adversely affect our business.

For example, over the last several years, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

If a prolonged government shutdown occurs, or if other concerns were to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Regulatory regimes in other countries similarly require approval or clearance prior to our marketing or selling products in those countries.

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We rely upon patent, trade secret, copyright, know-how and trademark laws, as well as license agreements and contractual provisions, to establish our intellectual property rights and protect our products.

However, no assurances can be made that any pending or future patent applications will result in the issuance of

patents, that any current or future patents issued to, or licensed by us, will not be challenged or circumvented by our competitors, or that our patents will not be found invalid.

However, no assurances can be made that any pending or future patent applications will result in the issuance of patents, that any current or future patents issued to, or licensed by us, will not be challenged or circumvented by our competitors, or that our patents will not be found invalid.

Patent positions of medical device companies, including our Company, are uncertain and involve complex and evolving legal and factual questions.

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• the growth of the market for our devices and services;

• the expansion and rate of success of our direct sales force in the United States and internationally and our independent distributors internationally;

• the expansion and rate of success of our direct sales force and our independent distributors;

• actions relating to ongoing FDA compliance;

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors