The Cooper Companies, Inc.
−Removed: (Cooper, we or the Company), is a global medical device company with a mission to improve lives one person at a time.
−Removed: We partner with health care providers worldwide to improve patient outcomes and deliver practice-building resources and training.
−Removed: By listening closely to the healthcare providers and patients, we fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment.
+Added: (Cooper, we or the Company), is a leading global medical device company focused on helping people experience life's beautiful moments.
+Added: Headquartered in San Ramon, California, Cooper sells products in over 130 countries and positively impacts over fifty million lives each year.
Cooper operates through two business segments, CooperVision and CooperSurgical.
8 unchanged sentences
CooperVision also manufactures and markets myopia management products, including the internally developed MiSight 1 day lens, as well as other specialty eyecare products such as orthokeratology (ortho-k) and scleral lenses.
−Removed: In November 2019, the MiSight 1 day lens became the first and only product approved by the United States Food and Drug Administration (FDA) for slowing the progression of myopia in children aged 8-12 at the initiation of treatment, and in August 2021, CooperVision received Chinese National Medical Products Administration (NMPA) approval for use of the MiSight 1 day lens in China.
+Added: In November 2019, the MiSight 1 day contact lens became the first and only product approved by the United States Food and Drug Administration (FDA) for slowing the progression of myopia in children aged 8-12 at the initiation of treatment.
+Added: CooperVision received approval for use of the MiSight 1 day lens in China from Chinese National Medical Products Administration (NMPA) in August 2021 and in Japan from the Japanese Ministry of Health, Labour and Welfare (MHLW) in August 2025.
CooperVision’s major manufacturing and distribution facilities are located in Belgium, Costa Rica, Hungary, Puerto Rico, the United Kingdom and the United States, with other smaller facilities in multiple locations around the world.
14 unchanged sentences
• Spherical lenses, including lenses that correct near- and farsightedness uncomplicated by more complex visual defects, myopia management lenses, which slow the progression of and correct myopia in age-appropriate children, and other specialty lenses.
−Removed: In order to achieve a comfortable and healthier lens wearing experience, products are sold with recommended wearing and replacement schedules, often referred to as modalities, with the primary modalities being single-use lenses designed for one-day use and frequent replacement (FRP) lenses designed for two-week and monthly replacement.
+Added: In order to achieve a comfortable and healthier lens wearing experience, CooperVision products are sold with recommended wearing and replacement schedules, often referred to as modalities, with the primary modalities being single-use lenses designed for one-day use and frequent replacement (FRP) lenses designed for two-week and monthly replacement.
CooperVision offers spherical, toric, multifocal and toric multifocal lens products in most modalities and in a wide range of lens parameters.
−Removed: CooperVision Product Modalities
THE COOPER COMPANIES, INC.
AND SUBSIDIARIES
+Added: CooperVision Product Modalities
Frequent replacement lenses
4 unchanged sentences
CooperVision markets single-use silicone hydrogel lenses under our MyDay brand and our clariti 1 day brand.
−Removed: The MyDay brand is our softest line of 1-day silicone hydrogel lenses and offers spherical (including MyDay Energys), toric, and multifocal lenses.
+Added: The MyDay brand is our premium line of 1-day silicone hydrogel lenses and offers spherical (including MyDay Energys), toric, and multifocal lenses.
The clariti 1-day brand is our most affordable line of silicone hydrogel 1-day lenses and offers spherical, toric, and multifocal lenses.
6 unchanged sentences
We believe that myopia management opens up an attractive new market for contact lenses.
−Removed: With MiSight, we offer the only FDA approved 1 and first Chinese NMPA approved product to slow the progression of, and correct, myopia in age-appropriate children.
+Added: With MiSight, we offer the only contact lens approved by the FDA 1 , Chinese NMPA, Japanese MHLW to slow the progression of, and correct, myopia in age-appropriate children.
This is a critical differentiator as the proactive management of myopia becomes standard-of-care within the eye care community to help reduce the progression of myopia in children, along with reducing the risks of long-term eye health problems associated with myopia such as cataracts, retinal detachment, and macular degeneration.
We are investing to develop this new market by educating eye care practitioners, patients and their families, which increases awareness.
−Removed: CooperVision is focused on greater worldwide market penetration of recently introduced products, and we continue to expand our presence in existing and emerging markets, both organically and through acquisitions.
+Added: CooperVision is focused on greater worldwide market penetration of recently introduced products, and we continue to expand our presence in existing and emerging markets.
CooperSurgical
3 unchanged sentences
The result is a broad portfolio of products and services that are intended to aid in the delivery of improved clinical outcomes for patients and are routinely used by health care professionals in the diagnosis and treatment of a wide spectrum of women's health and reproductive issues.
−Removed: CooperSurgical distributes its products and services through OB/GYN and medical offices, hospital and ambulatory surgery centers and fertility clinics, as well as direct-to-consumer.
+Added: CooperSurgical distributes its products and services worldwide through OB/GYN and medical offices, hospital and ambulatory surgery centers and fertility clinics, as well as direct-to-consumer.
A focus area for CooperSurgical is key accounts, which include large group practices, integrated delivery networks and certain buying groups within the office/surgical business and fertility clinic networks within the fertility business.
We believe our portfolio of offerings and focus on service, quality and clinical education will help increase our share of business within these key account groups.
−Removed: Since its inception in 1990, CooperSurgical has established its market presence and distribution system by developing products and acquiring products and companies that complement its business model.
−Removed: In fiscal 2024, CooperSurgical
1 MiSight 1 day (omafilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism.
2 unchanged sentences
AND SUBSIDIARIES
−Removed: acquired select Cook Medical assets focused primarily on the obstetrics, doppler monitoring, and gynecology surgery markets, a fertility company that specializes in sperm separation devices, and obp Surgical, a U.S.-based medical device company with a suite of single-use cordless surgical retractors with integrated light source and evacuation channels.
+Added: Since its inception in 1990, CooperSurgical has established its market presence and distribution system by developing products and acquiring products and companies that complement its business model.
We expect to continue investing in CooperSurgical's business, including through strategic transactions, with the goal of expanding our integrated solutions model within the areas of fertility and women's health.
4 unchanged sentences
Our newborn stem cell storage services are available in the United States, Canada and Australia.
−Removed: Paragard is a hormone-free intrauterine device (IUD) offered by CooperSurgical that prevents pregnancy for up to ten years using copper as the only active ingredient.
−Removed: It is the only FDA approved non-hormonal IUD contraceptive option and is exclusively sold in the United States.
+Added: Paragard is a hormone-free intrauterine device (IUD) offered by CooperSurgical exclusively in the United States that prevents pregnancy for up to ten years using copper as the only active ingredient.
CooperSurgical has broad product offerings for fertility evaluations and IVF procedures by OB/GYN professionals, reproductive endocrinologists and embryologists.
18 unchanged sentences
• The number of fertility clinics is rising worldwide.
+Added: • Single parents by choice and LGBTQIA+ individuals are starting families.
THE COOPER COMPANIES, INC.
AND SUBSIDIARIES
−Removed: • Single parents by choice and LGBTQIA+ individuals are starting families.
• Improved product offerings such as donor activity and cryopreservation services are becoming available.
6 unchanged sentences
CooperVision Competition
−Removed: CooperVision's largest competitors in the worldwide market and its primary competitors in the spherical, toric and multifocal lens categories of that market are Johnson & Johnson Vision Care, Inc., Alcon Inc.
−Removed: and Bausch + Lomb.
+Added: CooperVision competes in the spherical, toric and multifocal lens categories of the contact lens worldwide market against Johnson & Johnson Vision Care, Inc., Alcon Inc., Bausch + Lomb as well as other smaller companies with limited product offerings.
To a lesser extent, CooperVision also competes with manufacturers of eyeglasses and providers of other forms of vision correction including ophthalmic surgery.
6 unchanged sentences
CooperSurgical's strategy includes developing and acquiring new solutions to complement our current offerings.
−Removed: In the fertility market, CooperSurgical competes against Vitrolife Group, FujiFilm-Irvine Scientific, Hamilton Thorne, and Fairfax Cryobank and Fairfax EggBank.
+Added: In the fertility market, CooperSurgical competes against Vitrolife Group, Nexpring, and Fairfax Cryobank and Fairfax EggBank.
We also compete with fertility clinics offering their own services.
−Removed: Larger companies such as Johnson & Johnson, Medtronic and Hologic have offerings that compete with our medical device products.
−Removed: In the stem cell storage field, we compete primarily with ViaCord, a division of Revvity, in the United States, as well as other smaller companies globally.
+Added: Larger companies such as Johnson & Johnson, Baxter International, Medtronic and Hologic have offerings that compete with our medical device products.
+Added: In the stem cell storage field, we compete primarily with ViaCord, a division of Revvity, in the United States, as well as other smaller companies with limited product offerings globally.
With Paragard, we compete with manufacturers of hormonal IUDs including Bayer and AbbVie, Long Acting Reversible Contraceptives including Organon, and other forms of birth control.
−Removed: We are aware of a non-hormonal IUD under development, which may compete with Paragard in the future.
+Added: A non-hormonal IUD, Miudella, which has been FDA approved and not currently in the market, will compete with Paragard in the future.
Further, the continued consolidation of medical offices and fertility clinics may impact the competition for our products and services.
6 unchanged sentences
GOVERNMENT REGULATION
+Added: Our products are subject to extensive regulation by the FDA in the United States and a variety of regulatory agencies in other countries.
+Added: The process of obtaining regulatory approvals and the subsequent compliance with applicable federal,
THE COOPER COMPANIES, INC.
AND SUBSIDIARIES
−Removed: Our products are subject to extensive regulation by the FDA in the United States and a variety of regulatory agencies in other countries.
−Removed: The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.
+Added: state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.
These regulations govern, among other things, the design and development, testing, manufacturing, labeling, storage, record keeping, premarket clearance, approval or certification, post-market vigilance reporting, advertising and promotion, and sales and distribution of medical devices and pharmaceutical products.
3 unchanged sentences
Regulation in the United States
−Removed: Medical Devices
+Added: Medical Devices and In Vitro Diagnostic Devices
Most of our products are medical devices, which must comply with the Federal Food, Drug and Cosmetic Act (FDCA) and the regulations promulgated by the FDA thereunder.
28 unchanged sentences
In the United States, under the FDCA and the FDA’s regulatory framework, in vitro diagnostic devices (IVDs) are a type of medical device that can be used in the diagnosis or detection of diseases, such as cancer, or other conditions.
−Removed: The FDA considers Laboratory Developed Tests (LDTs) to be a subset of IVDs that are designed, manufactured, and used within a single laboratory.
−Removed: Furthermore, in May 2024, the FDA issued a final rule to amend its regulations to make explicit that LDTs are devices under the FDCA.
−Removed: Along with this amendment, the FDA is finalizing a policy under which the FDA will provide greater oversight of IVDs offered as LDTs through a phaseout of its general enforcement discretion approach for LDTs over the course of four years, as well as targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.
+Added: The FDA had previously considered Laboratory Developed Tests (LDTs) to be a subset of IVDs that are designed, manufactured, and used within a single laboratory.
+Added: In May 2024, the FDA issued the LDT Final Rule to amend its regulations to make explicit its finding that LDTs are devices under the FDCA.
+Added: Along with this amendment, the FDA issued a policy under which the FDA would provide greater oversight of IVDs offered as LDTs through a phaseout of its general enforcement discretion approach for LDTs over the course of four years, as well as targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.
+Added: On March 31, 2025, the U.S.
+Added: District Court for the Eastern District of Texas vacated the FDA’s LDT Final Rule, holding that LDTs are medical test services, not devices, and that oversight authority for laboratory testing resides with the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
+Added: The FDA declined to appeal the decision and, on September 19, 2025, formally rescinded the LDT Final Rule.
As we operate a genetic testing laboratory, we are required to hold certain federal, state and local licenses, certifications and permits to conduct our business.
−Removed: Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, we are required to hold a certificate applicable to the type of laboratory tests we perform and to comply with standards applicable to our operations, including test processes, personnel, facilities administration, equipment maintenance, recordkeeping, quality systems and proficiency testing.
+Added: Under the CLIA, we are required to hold a certificate applicable to the type of laboratory tests we perform and to comply with standards applicable to our operations, including test processes, personnel, facilities administration, equipment maintenance, recordkeeping, quality systems and proficiency testing.
We have current certification under CLIA to perform testing at our New Jersey facility.
In addition to federal certification requirements of laboratories under CLIA, licensure is required and maintained for our laboratory under state law.
+Added: As a manufacturer of connected medical devices, we are subject to evolving cybersecurity regulations and guidance issued by the FDA, including the final guidance titled Cybersecurity in Medical Devices:
+Added: Quality System Considerations and Content of Premarket Submissions (September 2023, updated June 2025).
+Added: Under Section 524B of the FDCA, effective March 29, 2023, all new premarket submissions and previously authorized devices undergoing new FDA review must comply with enhanced cybersecurity requirements.
+Added: These include:
+Added: • A comprehensive cybersecurity risk management plan;
+Added: • A detailed Software Bill of Materials (SBOM), listing all software components—including third-party and open-source elements—to support vulnerability tracking;
+Added: • Documentation of secure and reliable update mechanisms;
+Added: • Evidence of integration of cybersecurity into the device’s quality system as a core design control;
+Added: • Consideration of both premarket and postmarket cybersecurity risks throughout the product lifecycle.
+Added: These requirements reflect FDA’s emphasis on “security by design” and the implementation of a Secure Product Development Framework to ensure resilience against emerging threats.
+Added: We are following leading cybersecurity standards and practices to guide our strategies, processes, technologies and controls.
+Added: Our goal is to support the safety, security, and reliability of our connected medical devices while adapting to evolving threats and regulatory expectations.
Human cells, tissues, and cellular and tissue-based products
6 unchanged sentences
We believe our HCT/Ps are regulated as 361 HCT/Ps.
+Added: In addition to federal directives, there is a complex and evolving patchwork of state laws and regulations governing the use, storage, and disposition of human reproductive materials, including embryos, gametes, and other human tissue.
+Added: States vary widely in their approaches to assisted reproductive technologies, including IVF, embryo cryopreservation, and gamete donation.
+Added: As state legislatures continue to respond to evolving ethical, legal, and technological considerations, ongoing monitoring and adaptation are essential to maintaining compliance and continuity of care.
Pharmaceutical Products
In the United States, the FDA regulates pharmaceutical products under the FDCA and its implementing drug regulations.
−Removed: Although Paragard is a drug-device combination product, the FDA has determined that the primary mode of action for Paragard is the drug component and the product is therefore regulated by the FDA’s Center for Drug Evaluation and Research under applicable drug regulations.
+Added: Although Paragard is a drug-device combination product, the FDA has determined that the primary mode of action for
+Added: THE COOPER COMPANIES, INC.
+Added: AND SUBSIDIARIES
+Added: Paragard is the drug component and the product is therefore regulated by the FDA’s Center for Drug Evaluation and Research under applicable drug regulations.
The process required by the FDA before a drug may be marketed in the United States generally involves numerous and time-consuming steps, including preclinical laboratory tests, human clinical trials, FDA reviews, and facility inspections.
−Removed: Any drug products manufactured or distributed by us pursuant to NDA approvals are subject to continuing regulation by the FDA as the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
+Added: Any drug products manufactured or distributed by us pursuant to New Drug Application (NDA) approvals are subject to continuing regulation by the FDA as the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
After approval of an NDA, most changes to the approved product, such as adding new indications, manufacturing changes or other labeling claims, are subject to further testing requirements and prior FDA review and approval.
−Removed: Drug manufacturers and their subcontractors are also required to maintain compliance with cGMPs and other requirements, including requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product.
+Added: Drug manufacturers and their subcontractors are also required to maintain compliance with current good manufacturing practices (cGMPs) and other requirements, including requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain ongoing compliance.
7 unchanged sentences
CooperVision maintains ISO 13485 certification and CE marks for its products and CooperSurgical maintains ISO 13485 certification and CE marks for medical devices and ISO 15189 certification for the genomics laboratories.
−Removed: The ISO 13485 Quality Management System certification is now also required for registration of products in Asia Pacific and Latin American
−Removed: THE COOPER COMPANIES, INC.
−Removed: AND SUBSIDIARIES
−Removed: countries, among many other requirements for registration in these countries.
+Added: The ISO 13485 Quality Management System certification is now also required for registration of products in Asia Pacific and Latin American countries, among many other requirements for registration in these countries.
In order to maintain these quality benchmarks, the Company is subjected to rigorous biannual reassessment audits of its quality systems and procedures.
8 unchanged sentences
In the EU, the safety and performance of medical devices (including IVDs) are evaluated by the designated notified bodies via the submission of technical dossiers, depending on the product classifications.
−Removed: A declaration of conformity to the MDD or MDR is drawn out as a basis for European conformity marking (CE Mark).
+Added: A declaration of conformity to the EU MDD or EU MDR is drawn out as a basis for European conformity marking (CE Mark).
All medical devices placed on the EU market must meet general safety and performance requirements, including the requirement that a medical device must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose.
1 unchanged sentence
Compliance with the general safety and performance requirements is also a prerequisite for CE mark, without which medical devices cannot be marketed or sold in the EU.
−Removed: To demonstrate compliance with the general safety and performance requirements, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its risk classification.
+Added: To demonstrate compliance with the general safety and
+Added: THE COOPER COMPANIES, INC.
+Added: AND SUBSIDIARIES
+Added: performance requirements, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its risk classification.
With certain exceptions, a conformity assessment procedure requires the intervention of notified bodies, which are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market.
10 unchanged sentences
Medical Devices and In Vitro Diagnostic Medical Devices Regulations in the United Kingdom
−Removed: THE COOPER COMPANIES, INC.
−Removed: AND SUBSIDIARIES
Following the United Kingdom’s withdrawal from the EU, commonly referred to as Brexit, EU laws no longer apply directly in Great Britain (England, Wales and Scotland).
Under the terms of the Ireland/Northern Ireland Protocol agreed between the EU and United Kingdom, many EU laws, including those relating to medical devices and IVDs do still apply in Northern Ireland.
−Removed: In Great Britain, the legislative regime currently continues to be based on the requirements set out in the EU MDD, the Active Implantable Medical Devices Directive (EU AIMDD), and the EU IVDD.
−Removed: However, substantial reforms to the Great Britain regulatory regime for medical devices and IVDs are currently being developed to improve patient safety.
−Removed: Most of the reforms are to align with EU MDR requirements, but the Medicines and Healthcare products Regulatory Agency (MHRA) also intends to introduce unique requirements such as post market surveillance, software, and Artificial Intelligence from mid-2025.
+Added: Following Brexit, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published the MHRA Medical Devices Regulatory Reform:
+Added: Roadmap to Implementation which describes phased updates to the UK medical device and IVD regulatory framework.
+Added: These updates include new pre-market regulatory requirements and enhanced postmarket surveillance processes.
+Added: On June 16, 2025, strengthened postmarket surveillance requirements came into force for medical devices.
+Added: In 2025, the MHRA also held a consultation considering proposals to update the premarket requirements for medical devices and IVDs covering four topics, namely:
+Added: (1) a new international reliance scheme to enable swifter market access for certain devices that have already been approved in a comparable regulator country;
+Added: (2) the new UK Conformity Assessed (UKCA) mark and, in particular, proposals to remove the requirement to place UKCA marking on devices;
+Added: (3) conformity assessment procedures for in vitro diagnostic devices;
+Added: and (4) maintaining in UK law certain pieces of “assimilated” EU law which are due to sunset in 2025.
+Added: In July 2025, the MHRA published a response to the consultation confirming that it will incorporate the results of this consultation into new UK legislation for medical devices and IVDs.
+Added: Notable implications of this include:
+Added: • Medical devices in compliance with the EU MDD can continue to be placed on the UK market until the sooner of CE certificate expiration or June 30, 2028;
+Added: • Medical devices in compliance with the EU MDR can continue to be placed on the market until the sooner of CE certificate expiration or June 30, 2030;
+Added: • Certain IVDs in compliance with the EU IVDD or the EU IVDR can continue to be placed on the Great Britain market until the sooner of CE certificate expiration or June 30, 2030;
+Added: • The allocation, registration and labeling of Unique Device Identifiers (UDIs) may replace the requirement to physically affix the UKCA mark to medical devices and IVDs.
+Added: THE COOPER COMPANIES, INC.
+Added: AND SUBSIDIARIES
Medical Device and In Vitro Diagnostic Medical Device Regulation in Asia Pacific
24 unchanged sentences
• the federal False Claims Act, which prohibits any individual or entity from presenting or causing to be presented false claims for payment to the federal government;
−Removed: THE COOPER COMPANIES, INC.
−Removed: AND SUBSIDIARIES
• federal and state laws that prohibit executing, or attempting to execute, a scheme to obtain money from any healthcare benefit program under false pretenses;
2 unchanged sentences
Coverage and Reimbursement
−Removed: Market acceptance and sales of our CooperSurgical products to our customers, who primarily consist of hospitals and surgery centers, OB/GYN medical offices and fertility clinics, will depend on the availability of payor coverage and the adequacy of reimbursement, for the procedures using our products, by government insurance programs and other third-party payors.
+Added: Market acceptance and sales of our CooperSurgical products to our customers, who primarily consist of hospitals and surgery centers, OB/GYN medical offices and fertility clinics, will depend on the availability of payor coverage and the
+Added: THE COOPER COMPANIES, INC.
+Added: AND SUBSIDIARIES
+Added: adequacy of reimbursement, for the procedures using our products, by government insurance programs and other third-party payors.
Payor coverage and reimbursement for procedures using medical devices in the United States and international markets vary significantly by country.
1 unchanged sentence
We believe the overall escalating cost of medical products and services being paid for by the government and private health insurance has led to, and will continue to lead to, increased pressures on the healthcare and medical device industry to reduce the costs of products and services.
+Added: Likewise, coverage decisions can vary widely by payor and may be subject to frequent updates.
+Added: Reimbursement levels may be reduced or eliminated altogether, and coverage may be denied or restricted based on clinical guidelines, cost-effectiveness assessments, or changes in regulatory classification.
+Added: Even the perception of potential changes in coverage—such as proposed rulemaking, draft guidance, or litigation affecting reimbursement frameworks—can lead to volatility in demand, as providers and patients may delay or avoid use of our products pending greater clarity.
Healthcare Reform
4 unchanged sentences
Additionally, there has recently been heightened scrutiny by governmental authorities, individual hospitals, and third-party payors over product prices, which has resulted in proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for pharmaceutical products.
−Removed: Most recently, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law.
−Removed: Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap;
−Removed: imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);
−Removed: and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
+Added: The Inflation Reduction Act of 2022 (IRA) continues to be implemented, with Medicare drug price negotiations expanding in scope.
+Added: Beginning in 2026, negotiated prices for selected high-cost drugs will take effect, and the out-of-pocket cap for Medicare Part D enrollees will rise to $2,100.
+Added: Additionally, manufacturers are subject to inflation-based rebates for price increases that exceed inflation benchmarks.
+Added: These provisions are expected to exert downward pressure on drug pricing and may influence commercial strategies for affected products.
+Added: Further, the One Big Beautiful Bill Act of 2025 (OBBBA) introduced significant changes to Medicaid and ACA marketplace eligibility, including new verification and work requirements, and reductions in federal support for medical education and physician reimbursement.
+Added: These changes may affect patient access to care and alter the reimbursement environment for providers and manufacturers.
In the EU, regulations have been adopted which are intended to boost cooperation among EU member states in assessing health technologies, including certain high-risk medical devices, and providing the basis for cooperation at the EU level for joint clinical assessments in these areas.
2 unchanged sentences
We are subject to various other federal, state and foreign laws related to the manufacturing and distribution of our products and to our international operations, including export control and trade compliance laws.
−Removed: THE COOPER COMPANIES, INC.
−Removed: AND SUBSIDIARIES
RAW MATERIALS
1 unchanged sentence
However, in certain instances we acquire components and materials from sole suppliers to make our silicone hydrogel contact lens, certain medical devices and IVF products.
−Removed: Supply of these materials is protected by contractual agreements and safety stocks.
+Added: Supply of these materials
+Added: THE COOPER COMPANIES, INC.
+Added: AND SUBSIDIARIES
+Added: is protected by contractual agreements and safety stocks.
However, if current raw material suppliers fail to supply sufficient materials on a timely basis, or at all for any reason, we could experience inventory shortages and disruption in the supply of products if we were required to use an alternative supplier on short notice.
6 unchanged sentences
With the addition of MiSight, CooperVision has expanded the breadth and depth of its sales capabilities by adding myopia management specialists while expanding awareness campaigns to include direct-to-consumer elements including print, internet/social media, radio and television.
−Removed: CooperSurgical's products are marketed by a network of dedicated field sales representatives, independent agents and distributors.
+Added: CooperSurgical's products are marketed by a network of dedicated field sales representatives, inside sales and distributors.
CooperSurgical augments its sales and marketing activities by participating in national and regional industry trade shows, professional educational programs and internet promotions including e-commerce, search and social media and collaborative efforts with professional organizations, telemarketing, direct mail and advertising in professional journals.
14 unchanged sentences
Human capital management areas of focus include a people-focused culture;
−Removed: embedding diversity and inclusion;
+Added: embedding connection and belonging;
fostering an environment of health, safety, and well-being;
2 unchanged sentences
We believe we have good relations with our workforce, and we invest in our workforce to meet current and future business objectives, always driving towards our goal of being a global employer of choice.
−Removed: The chart below shows percentage of employees located in Americas, EMEA and Asia Pacific as of October 31, 2024.
THE COOPER COMPANIES, INC.
AND SUBSIDIARIES
−Removed: Diversity and Inclusion
+Added: The chart below shows percentage of employees located in Americas, EMEA and Asia Pacific as of October 31, 2025.
+Added: Connection and Belonging
We believe that an inclusive work environment that truly appreciates the diversity of employees’ talents, experiences, and ideas leads to more innovation and progress.
−Removed: Through our Diversity & Inclusion (D&I) strategy, we drive a culture where individual qualities and backgrounds are highly valued and respected, and our employees feel a sense of belonging.
−Removed: Our D&I strategy includes initiatives to promote D&I conversations and training to inform and educate our workforce, forming communities of advocates and allies to help advance our culture of inclusion, and completion of various reviews of our programs to minimize the impact of unconscious bias on our reward decisions.
−Removed: Our commitment to D&I starts with our executives and is further executed through local initiatives in order to create sustainable change.
+Added: Through our Connection & Belonging (C&B) strategy, we drive a culture where individual qualities and backgrounds are highly valued and respected, and our employees feel a sense of belonging.
+Added: Our C&B strategy includes initiatives to promote C&B conversations and training to inform and educate our workforce, forming communities of advocates and allies to help advance our culture, and completion of various reviews of our programs to minimize the impact of unconscious bias on our reward decisions.
+Added: Our commitment to C&B starts with our executives and is further executed through local initiatives in order to create sustainable change.
Health, Safety and Well-being
19 unchanged sentences
We also offer comprehensive and continually evolving benefits to help employees balance their work lives and personal lives.
+Added: THE COOPER COMPANIES, INC.
+Added: AND SUBSIDIARIES
AVAILABLE INFORMATION
2 unchanged sentences
The information on the Company's website is not part of this or any other report we file with, or furnish to, the Securities and Exchange Commission (SEC).
−Removed: THE COOPER COMPANIES, INC.
−Removed: AND SUBSIDIARIES
−Removed: reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, along with all other reports and amendments filed with or furnished to the SEC, are publicly available free of charge on our website as soon as reasonably practicable.
+Added: Our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, along with all other reports and amendments filed with or furnished to the SEC, are publicly available free of charge on our website as soon as reasonably practicable.
The SEC maintains a website that contains such reports, proxy and information statements and other information whose Internet address is https://www.sec.gov.
3 unchanged sentences
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.