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Sun Nov 1 · markets closed1 signal on Oct 31129 insider buys this week · $10BCIRO short report next: Nov 15The week ahead

HAE

HAEMONETICS CORP
NYSE · HEALTH CARE · SURGICAL & MEDICAL INSTRUMENTS & APPARATUS
119.65
−0.14 −0.12%
USD · close Oct 30
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MKT CAP $5.4BP/E 57.8DIV YIELD —FCF YIELD 5.35%REV TTM $1.4B +0.4%NET INCOME $96.3M −41.1%NET DEBT $964.8M52W 50.27 – 122.06SEC XBRL · TTM TO Invalid Date

How HAE rewrote its risk factors

10-K ITEM 1A · FY2025 → FY2026
Text kept
59%
of sentences unchanged
Added
101
new sentences
Dropped
79
sentences removed
Length
+608
words, now 12,376

New in FY2026

  • Risk Factors in this report. • Our ability to achieve our long-term strategic and financial-improvement goals; • Demand for and market acceptance risks for new and existing products, including material reductions in purchasing from or loss of a significant customer; • Our ability to develop, manufacture and market new products and technologies successfully and in a timely manner and the ability of our competitors and other third parties to develop products or technologies that render our products or technologies noncompetitive or obsolete; • Product quality or safety concerns, leading to product recalls, withdrawals, regulatory action by the FDA (or similar non-U.S. regulatory agencies), reputational damage, declining sales or litigation; • Security breaches of our products or information technology systems, or those of our customers, suppliers or other business partners, which could impair our ability or our customers’ ability to conduct business or compromise sensitive information of the Company or its customers, suppliers and other business partners, or of customers’ patients; • The potential that the expected strategic benefits and opportunities from completed or planned acquisitions, including the Company’s acquisitions of Vivasure Medical Limited (“Vivasure”), OpSens Inc. and Advanced Cooling Therapy, Inc., d/b/a Attune Medical (“Attune Medical”), divestitures or other strategic investments by the Company may not be realized or may take longer to realize than expected; • Pricing pressures resulting from trends toward healthcare cost containment, including the continued consolidation among healthcare providers and other market participants; • Disruptions to the continuity, availability and pricing of plastic and other raw materials, finished goods and components used in the manufacturing of our products (including those purchased from sole-source suppliers) and the related continuity of our manufacturing, sterilization, supply chain and distribution operations, including disruptions caused by natural disasters, extreme weather and other conditions caused by or related to climate change, labor strikes, terrorism acts, cyber incidents or other adverse events; • Our ability to obtain the anticipated benefits of restructuring programs that we have or may undertake, including our ongoing market and regional alignment and portfolio rationalization initiatives; • The impact of enhanced requirements to obtain regulatory approval in the U.S. and around the world and the associated timing and cost of product approval; • Our ability to comply with established and developing U.S. and foreign legal and regulatory requirements, including the U.S.
  • Foreign Corrupt Practices Act, European Union Medical Device Regulation and In Vitro Diagnostic Regulation and similar laws in other jurisdictions, as well as the impact of U.S. and foreign export and import restrictions and tariffs; • The impact of changes in U.S. and international tax laws; • Our ability to meet our debt obligations and raise additional capital when desired on terms reasonably acceptable to us; • The potential impact of our convertible senior notes and related capped call transactions; • Geopolitical and economic conditions in China, Taiwan, Russia, Ukraine, Iran and other parts of the Middle East, and other foreign jurisdictions where we do business; • Our ability to execute and realize anticipated benefits from our investments in emerging economies; • The potential effect of foreign currency fluctuations and interest rate fluctuations on our net sales, expenses and resulting margins; • Our ability to protect intellectual property and the outcome of patent litigation; • Costs and risks associated with product liability and other litigation claims we may be subject to now or in the future; • Our ability to retain and attract key personnel; • Market conditions impacting our stock price and/or our share repurchase program, and the possibility that such share repurchase program may be delayed, suspended or discontinued; • Our ability to achieve against our corporate responsibility initiatives and meet evolving stakeholder expectations concerning corporate responsibility matters; and • The impact of actual or threatened public health crises.
  • If we have not correctly identified the product categories with the greatest growth potential, we will not allocate our resources appropriately which could have a material adverse effect on our business, financial condition or results of operations.
  • In fiscal 2026, our ten largest customers accounted for approximately 44% of our net reve nues.
  • A material portion of sales in our Plasma segment come from (and we anticipate will continue to come from) a limited number of customers.
  • In fiscal 2026, one Plasma customer accounted for approximately 13% of total net revenues.
  • In addition, the medical device markets in which we participate and the healthcare industry generally are characterized by extensive research and development and rapid technological change.
  • We have sought and in the future may seek to supplement our organic growth through strategic acquisitions, investments and alliances, including our acquisitions of Vivasure Medical Limited, OpSens Inc. and Attune Medical.
  • We have also sought and in the future may seek to divest certain assets deemed non-core to our long-term strategic objectives, including our divestiture in January 2025 of the Whole Blood product line and related assets within our Blood Center business unit.
  • While we have invested and continue to invest in the protection of personal information and proprietary or confidential information, there can be no assurance that our efforts will prevent cyber-attacks, intrusions, breakdowns or other incidents or ensure compliance with all applicable securities and privacy laws, regulations and standards.
  • We are required to comply with increasingly complex and changing legal and regulatory requirements that govern the collection, use, storage, security, transfer, disclosure and other processing of personal data in the United States and in other countries, including, but not limited to, HIPAA, HITECH, the California Consumer Privacy Act (“CCPA), the California Privacy Rights Act, and the EU’s General Data Protection Regulation (“GDPR”).
  • In addition, information security and privacy laws continue to come into effect in China and other countries where we conduct business.
  • We or our third-party providers and business partners may also be subjected to audits or investigations by one or more domestic or foreign government agencies relating to compliance with information security and privacy laws and regulations, and noncompliance with the laws and regulations could result in material fines or litigation.
  • An inability to successfully manage the implementation of our new global enterprise resource planning system could adversely affect our operations and operating results.
  • We are in the process of implementing a new global enterprise resource planning system.
  • This system will replace many of our existing operating and financial systems.
  • The implementation is a major undertaking, both financially and from a management and personnel perspective.
  • Any material disruptions, delays or deficiencies in the design and implementation of our new enterprise resource planning system could adversely affect our ability to process orders, ship products, provide services and customer support, send invoices and track payments, fulfill contractual obligations or otherwise operate our business.
  • Additionally, the influence of integrated delivery networks, group purchasing organizations and large single accounts has the potential to put price pressure on our Hospital business.
  • This complexity is enhanced by global macroeconomic conditions and uncertainty, including inflation, tariffs, interest rates, monetary policy, exchange rates and geopolitical developments.
  • Many of our products also require sterilization prior to sale or distribution and we utilize contract sterilizers to perform this service.
  • To the extent our contract sterilizers are unable to sterilize our products, whether due to capacity, availability of materials for sterilization, regulatory or other constraints, including federal and state regulations on the use of ethylene oxide, we may be unable to transition to alternative resources or methods in a timely or cost effective manner, or at all, which could have a material impact on our results of operations and financial condition.
  • In addition, we manufacture our VASCADE vascular closure devices under a shelter plan service agreement with Offshore International Incorporated (d/b/a Tetakawi) pursuant to which we lease our manufacturing facility in Guaymas, Mexico.
  • Due to the high standards and stringent requirements of the FDA and other similar non-U.S. regulatory agencies applicable to manufacturing our products, such as the FDA’s QMSR and cGMP regulations, we also may not be able to quickly establish additional or replacement sources for certain raw materials, components or finished goods.
  • During the first quarter of fiscal 2026, our Board of Directors approved our ongoing market and regional alignment initiative, a company-wide restructuring initiative designed to improve operational performance and reduce costs by directing the Company’s resources toward the markets and geographies that offer the greatest growth and portfolio advancement opportunities, and delegated authority to the Company's management to determine the details of the specific actions that will comprise the initiative.
  • Our market and regional alignment initiative could also yield unintended consequences, such as business disruption, the loss of institutional knowledge as a result of turnover and reduced employee productivity, which could negatively affect our business, sales, financial condition and results of operations.
  • Our inability to realize all of the anticipated benefits from our market and regional alignment initiative could have a material adverse effect on our business, results of operations, cash flows and financial condition.
  • Risks Related to Government Regulation As a medical device manufacturer, we operate in a highly regulated industry, and non-compliance with applicable laws or regulations could adversely affect our financial condition and results of operations.
  • Before a new medical device, or a new use of an existing product, can be marketed in the United States, it must first receive either premarket clearance under Section 510(k) of the FDCA, a grant of a request for de novo classification or a premarket approval, or PMA, from the FDA, unless an exemption applies.
  • For example, in 2025 Vivasure submitted a PMA application to the FDA for the PerQseal Elite arterial closure system that is currently under FDA review.
  • The process of obtaining regulatory authorization to market a medical device can be costly and time-consuming, and we may not be able to obtain these authorizations on a timely basis, if at all.
  • Similarly, the separation of states from participation in the EU, such as Brexit and Swexit, may result in further regulatory risk and complexity as the former EU member or participant state establishes separate laws and regulations governing medical products.
  • Additionally, FDA and foreign regulations and guidance are often revised or reinterpreted by the FDA and foreign counterparts in ways that may significantly affect our business and our products.
  • Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products or make it more difficult to obtain clearance, approval, or certification to manufacture, market or distribute our products.
  • We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future.
  • Such changes could, among other things, require: additional testing prior to obtaining clearance, approval, or certification; changes to manufacturing methods; recall, replacement or discontinuance of our products; or additional record keeping.
  • For example, on February 2, 2026, the FDA’s final rule implementing the QMSR became effective.
  • The QMSR, which replaced the FDA’s former Quality System Regulation, sets forth the FDA’s cGMP requirements for medical devices, and among other things, incorporates by reference certain elements of the quality management system requirements of ISO 13485:2016.
  • Although the FDA has stated that the standards contained in ISO 13485:216 are substantially similar to those set forth in the QSR, and although we have obtained ISO 13485:2016 certification for our quality management system, the FDA has indicated that ISO:13485 certification alone will not ensure compliance under the QMSR, nor will ISO certification exempt manufacturers from FDA inspection.
  • The QMSR also includes certain compliance obligations, such as those relating to unique device identification, product traceability, and maintenance of complaint and service records, which align more closely with FDA’s existing medical device requirements than with ISO standards.

and 61 more.

Gone since FY2025

  • Risk Factors in this report. • Our ability to achieve our long-term strategic and financial-improvement goals; • Demand for and market acceptance risks for new and existing products, including material reductions in purchasing from or loss of a significant customer; • Our ability to develop, manufacture and market new products and technologies successfully and in a timely manner and the ability of our competitors and other third parties to develop products or technologies that render our products or technologies noncompetitive or obsolete; • Product quality or safety concerns, leading to product recalls, withdrawals, regulatory action by the FDA (or similar non-U.S. regulatory agencies), reputational damage, declining sales or litigation; • Security breaches of our products or information technology systems, or those of our customers, suppliers or other business partners, which could impair our ability or our customers’ ability to conduct business or compromise sensitive information of the Company or its customers, suppliers and other business partners, or of customers’ patients; • The potential that the expected strategic benefits and opportunities from completed or planned acquisitions, including the Company’s acquisitions of OpSens Inc. and Attune Medical, divestitures or other strategic investments by the Company may not be realized or may take longer to realize than expected; • Pricing pressures resulting from trends toward healthcare cost containment, including the continued consolidation among healthcare providers and other market participants; • Disruptions to the continuity, availability and pricing of plastic and other raw materials, finished goods and components used in the manufacturing of our products (including those purchased from sole-source suppliers) and the related continuity of our manufacturing, sterilization, supply chain and distribution operations, including disruptions caused by natural disasters, extreme weather and other conditions caused by or related to climate change, labor strikes, terrorism acts, cyber incidents or other adverse events; • Our ability to obtain the anticipated benefits of restructuring programs that we have or may undertake, including our market and regional alignment and portfolio rationalization initiatives; • The impact of enhanced requirements to obtain regulatory approval in the U.S. and around the world and the associated timing and cost of product approval; • Our ability to comply with established and developing U.S. and foreign legal and regulatory requirements, including the U.S.
  • Foreign Corrupt Practices Act, European Union Medical Device Regulation and In Vitro Diagnostic Regulation and similar laws in other jurisdictions, as well as the impact of U.S. and foreign export and import restrictions and tariffs; • The impact of changes in U.S. and international tax laws; • Our ability to meet our debt obligations and raise additional capital when desired on terms reasonably acceptable to us; • The potential impact of our convertible senior notes and related capped call transactions; • Geopolitical and economic conditions in China, Taiwan, Russia, Ukraine, the Middle East and other foreign jurisdictions where we do business; • Our ability to execute and realize anticipated benefits from our investments in emerging economies; • The potential effect of foreign currency fluctuations and interest rate fluctuations on our net sales, expenses and resulting margins; • Our ability to protect intellectual property and the outcome of patent litigation; • Costs and risks associated with product liability and other litigation claims we may be subject to now or in the future; • Our ability to retain and attract key personnel; • Market conditions impacting our stock price and/or our share repurchase program, and the possibility that such share repurchase program may be delayed, suspended or discontinued; • Our ability to achieve against our corporate responsibility initiatives and meet evolving stakeholder expectations concerning corporate responsibility matters; and • The impact of actual or threatened public health crises.
  • If we have not correctly identified the product categories with greatest growth potential, we will not allocate our resources appropriately which could have a material adverse effect on our business, financial condition or results of operations.
  • In fiscal 2025, our ten largest customers accounted for approximately 42% of our net reve nues.
  • Although we did not have any customers that represented more than 10% of our consolidated revenues in fiscal 2025, a material portion of sales in our Plasma segment come from (and we anticipate will continue to come from) a limited number of customers.
  • As previously disclosed, one of our largest Plasma customers, CSL, informed us in April 2021 of its intent not to renew its supply agreement for the use of PCS2 ® plasma collection system devices and the purchase of disposable plasmapheresis kits in the U.S. following the expiration of the then current term of its contract, which was subsequently extended on a non-exclusive basis through December 2025.
  • In addition, the medical device markets in which we participate and healthcare industry generally are characterized by extensive research and development and rapid technological change.
  • We have sought and in the future may seek to supplement our organic growth through strategic acquisitions, investments and alliances, including our recent acquisitions of OpSens Inc. and Attune Medical.
  • We have also sought and in the future may seek to divest certain assets deemed non-core to our long-term strategic objectives, including our recent divestiture of the Whole Blood product line and related assets within our Blood Center business unit.
  • We also may face operational interruptions as we continue to upgrade our global enterprise resource planning system.
  • While we have invested and continue to invest in the protection of personal information and proprietary or confidential information, there can be no assurance that our efforts will prevent cyber-attacks, intrusions, breakdowns or other incidents or ensure compliance with all applicable securities and privacy laws, regulations, standard standards.
  • We are required to comply with increasingly complex and changing legal and regulatory requirements that govern the collection, use, storage, security, transfer, disclosure and other processing of personal data in the United States and in other countries, including, but not limited to, HIPAA, HITECH, the California Consumer Privacy Act, or CCPA, the California Privacy Rights Act, and the EU’s General Data Protection Regulation, or GDPR.
  • In addition, new information security and privacy laws have also come into effect in China and other countries where we conduct business.
  • We or our third-party providers and business partners may also be subjected to audits or investigations by one or more domestic or foreign government agencies relating to compliance with information security and privacy laws and regulations, and noncompliance with the laws and regulations could results in material fines or litigation.
  • The influence of integrated delivery networks, group purchasing organizations and large single accounts has the potential to put price pressure on our Hospital business.
  • Blood Center customers who are also facing reduced demand for red cells.
  • Our Blood Center customers have responded to this pressure by creating their own group purchasing organizations and resorting to single source tenders to create incentives for suppliers, including us, to significantly reduce prices.
  • This complexity is enhanced by global macroeconomic conditions and uncertainty, including around inflation, tariffs, interest rates, monetary policy, exchange rates and geopolitical developments.
  • Many of our products also require sterilization prior to sale or distribution and we utilize a mix of internal resources and contract sterilizers to perform this service.
  • To the extent we or our contract sterilizers are unable to sterilize our products, whether due to capacity, availability of materials for sterilization, regulatory or other constraints, including federal and state regulations on the use of ethylene oxide, we may be unable to transition to alternative internal or external resources or methods in a timely or cost effective manner, or at all, which could have a material impact on our results of operations and financial condition.
  • In addition, we manufacture our vascular closure devices under a shelter plan service agreement with Offshore International Incorporated (d/b/a Tetakawi) pursuant to which we lease our manufacturing facility in Guaymas, Mexico.
  • Due to the high standards and stringent requirements of the FDA and other similar non-U.S. regulatory agencies applicable to manufacturing our products, such as the FDA’s QSR and cGMP regulations, we also may not be able to quickly establish additional or replacement sources for certain raw materials, components or finished goods.
  • During the first quarter of fiscal 2026, our Board of Directors approved a new market and regional alignment initiative, a company-wide restructuring initiative designed to improve operational performance and reduce costs by directing the Company’s resources toward the markets and geographies that offer the greatest growth and portfolio advancement opportunities, and delegated authority to the Company's management to determine the details of the specific actions that will comprise the initiative.
  • The market and regional alignment initiative could also yield unintended consequences, such as business disruption, the loss of institutional knowledge as a result of turnover and reduced employee productivity, which could negatively affect our business, sales, financial condition and results of operations.
  • Our inability to realize all of the anticipated benefits from the market and regional alignment initiative could have a material adverse effect on our business, results of operations, cash flows and financial condition.
  • Risks Related to Government Regulation As a medical device and drug manufacturer, we operate in a highly regulated industry, and non-compliance with applicable laws or regulations could adversely affect our financial condition and results of operations.
  • Before a new medical device, or a new use of an existing product can be marketed in the United States, it must first receive either premarket clearance under Section 510(k) of the U.S.
  • Federal Food, Drug, and Cosmetic Act, or FDCA, a grant of a request for de novo classification or a Premarket Approval, or PMA, from the FDA, unless an exemption applies.
  • Similarly, before a new drug can be marketed in the U.S., it must first receive approval of a new drug application or abbreviated new drug application under the FDCA.
  • The process of obtaining regulatory authorization to market a medical device or a drug can be costly and time-consuming, and we may not be able to obtain these authorizations on a timely basis, if at all.
  • Similarly, the separation of states from participation in the EU, such as through the cessation of the United Kingdom’s membership in the EU (commonly known as “Brexit”) and the separation of the Swiss and EU medical product markets with the adoption of the EU MDR (commonly referred to as “Swexit”), may result in further regulatory risk and complexity as the former EU member or participant state establishes separate laws and regulations governing medical products.
  • In particular, we and our third-party suppliers must comply with the FDA’s QSR or cGMP requirements (depending on the products at issue), which address, among other things, the methods of documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products.
  • As a medical device and drug manufacturer, we are subject to safety reporting requirements.
  • In addition, drug manufacturers are required to report adverse drug experiences associated with the use of a drug and submit field alert reports for instances of contamination, change or deterioration of the distributed product or failure to meet specifications.
  • The Pillar Two Global Anti-Base Erosion Rules is currently effective in some of the jurisdictions in which we operate.
  • Other countries are considering enacting laws consistent with the Pillar Two rules, while still others have yet to announce their intention to adopt.
  • The United States has not enacted the Pillar Two global minimum tax and the current administration recently announced its intention to effectively withdraw from the OECD Inclusive Framework as well as its intention to enact retaliatory measures against countries who assert extraterritorial taxes against U.S. taxpayers.
  • The OECD continues to issue guidance on the Pillar Two framework, with new rules released as recently as January, 2025.
  • Such changes may also apply prospectively or retroactively to our historical operations and result in taxes greater than the amounts estimated and recorded in our financial statements, and any such changes could have a material impact on our effective tax rate and on our business, results of operations, financial condition, and cash flows.
  • In May 2024, the Company issued $700.0 million aggregate principal amount of indebtedness under the Company’s convertible notes due 2029, or 2029 Notes, and used $230.0 million of the proceeds to repay the entirety of the previously outstanding balance under the Company’s senior unsecured revolving credit facility and $185.5 million of the proceeds to repurchase $200.0 million in aggregate principal amount of the Company’s convertible senior notes due 2026, or 2026 Notes.

and 39 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2025 ↗, FY2026 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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