What changed in this filing

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Item 1. Business

2024-12-06 compared with 2023-12-08 · 63 added, 76 removed, 305 unchanged (31% of the section changed)

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We categorize CooperSurgical product sales based on the point of health care delivery, which includes:

products used in medical offices, ambulatory surgical centers and hospitals primarily by Obstetricians/Gynecologists (OB/GYN);

products used in medical offices, ambulatory surgery centers and hospitals primarily by women's health providers including Obstetricians/Gynecologists (OB/GYN);

and fertility products and services used primarily in fertility clinics.

Our portfolio encompasses more than 600 products and services.

Our medical devices are used in gynecology and obstetrics, including but not limited to contraception and labor and delivery as well as cord blood and cord storage services.

Our fertility portfolio encompasses medical devices supporting the in vitro fertilization (IVF) cycle, egg and sperm donation, cryopreservation, and genomic services (including genetic testing).

Our medical devices are used in gynecology and obstetrics, including but not limited to surgical products, contraception and labor and delivery as well as cord blood and cord tissue storage services.

Our fertility portfolio encompasses medical devices supporting the in vitro fertilization (IVF) process, egg and sperm donation, cryopreservation, and genomic services (including genetic testing).

CooperSurgical has established its market presence and distribution system by developing products and acquiring companies, products and services that complement its business model.

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The two major product categories of contact lenses sold by CooperVision are:

• 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.

• Toric and multifocal lenses, including lenses that, in addition to correcting near- and farsightedness, address more complex visual defects such as astigmatism, myopia and presbyopia by adding optical properties of cylinder and axis, which correct for irregularities in the shape of the cornea;

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.

CooperVision offers spherical, toric, multifocal and toric multifocal lens products in most modalities and in a wide range of lens parameters.

CooperVision Product Modalities

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CooperVision Product Modalities

Frequent replacement lenses

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CooperVision focuses on supporting the growth of all customers including key accounts (which include optical chains, global retailers, certain buying groups and mass merchandisers) by investing in selling, promotional and advertising activities.

Further, we are increasing investment in our distribution and packaging capabilities to support the growth of our business and to continue providing quality service with our industry leading stock keeping unit ("SKU") range and customized offerings.

Market for Contact Lenses

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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.

In fiscal 2023, CooperVision acquired a private U.S.-based company that provides a broad portfolio of technologically advanced contact lens products, including scleral and hybrid lenses.

In fiscal 2022, CooperVision acquired a private Denmark-based ortho-k contact lens distributor.

These acquisitions expanded CooperVision’s specialty eye care portfolio and its leadership in addressing the increasing severity and prevalence of myopia.

CooperSurgical

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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.

1 Indications for use of 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.

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.

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.

The lens is to be discarded after each removal.

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AND SUBSIDIARIES

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.

In fiscal 2022, CooperSurgical acquired both a private cryopreservation services company and Generate Life Sciences (Generate), a private leading provider of donor egg and sperm for fertility treatments, fertility cryopreservation services and newborn stem cell storage (cord blood and cord tissue).

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.

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.

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Office/Surgical

CooperSurgical sells a wide variety of innovative medical devices and services used in gynecology and obstetrics, including in labor and delivery, as well as to screen, diagnose and treat women's health and reproductive issues.

CooperSurgical offers the cryostorage of newborn cord blood and cord tissue, which are potent sources of stem cells that have the potential for treatment and healing.

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CooperSurgical participates in the market for women's and family health care with its diversified product lines at various points of health care delivery:

OB/GYN medical offices, hospitals and surgical centers, and fertility clinics.

In recent years, including with the acquisition of Generate in fiscal 2022, CooperSurgical’s business increasingly includes marketing and selling to end consumers through our cryostorage (such as cord blood and cord tissue storage) and reproductive planning products and services.

CooperSurigcal expects that OB/GYN medical offices and fertility clinics will continue to move away from private practice ownership and toward group practices and networks.

OB/GYN medical offices, hospitals and surgery centers, and fertility clinics.

CooperSurgical’s business also includes cryostorage services for gametes, cord blood and cord tissue.

CooperSurgical expects that OB/GYN medical offices and fertility clinics will continue to move away from private practice ownership and toward group practices, private equity, corporate or other ownership.

As the consolidation trend continues it will have increased influence over supply chain control, group purchases, value analysis committees, product evaluation and procurement.

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Trends specific in the OB/GYN market include:

• The increase in office-based and outpatient procedures, given high patient satisfaction, reduction of healthcare costs and comparative clinical outcomes.

• The increase in office-based and outpatient procedures, given increased access to care, high patient satisfaction, reduction of healthcare costs and comparative clinical outcomes.

• A focus on reducing pregnancy and childbirth complications.

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• Patient awareness of, and access to, services is increasing.

• The number of fertility clinics is rising worldwide.

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• The number of fertility clinics is rising worldwide.

• Single parents by choice and LGBTQIA+ individuals are starting families.

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CooperSurgical's strategy includes developing and acquiring new solutions to complement our current offerings.

In the fertility market, CooperSurgical competes against Vitrolife Group, FujiFilm-Irvine Scientific, Cook Medical, Hamilton Thorne, and Fairfax Cryobank and Fairfax EggBank.

In the fertility market, CooperSurgical competes against Vitrolife Group, FujiFilm-Irvine Scientific, Hamilton Thorne, and Fairfax Cryobank and Fairfax EggBank.

We also compete with fertility clinics offering their own services.

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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.

With PARAGARD, we compete with manufacturers of hormonal IUDs including Bayer and AbbVie, Long Acting Reversible Contraceptives (LARCs) including Organon, and other forms of birth control.

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.

We are aware of a non-hormonal IUD under development, which may 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.

RESEARCH AND DEVELOPMENT

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CooperSurgical research and development activities are focused on innovating, improving, and advancing our products and services including, instruments, devices, consumables, digital services, and manufacturing technologies.

GOVERNMENT REGULATION

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GOVERNMENT REGULATION

Our products are subject to extensive regulation by the FDA in the United States and a variety of regulatory agencies in other countries.

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and medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur.

The FDA has broad post-market and regulatory enforcement powers.

We are subject to unannounced inspections for cause by the FDA to determine our compliance with the QSR and other regulations.

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broad post-market and regulatory enforcement powers.

We are subject to unannounced inspections for cause by the FDA to determine our compliance with the QSR and other regulations.

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.

The FDA considers Laboratory Developed Tests (LDTs) to be a subset of IVDs that are designed, manufactured, and used within a single laboratory.

Furthermore, in October 2023, the FDA published a proposed rule to amend its regulations to make explicit that LDTs are devices under the FDCA.

Furthermore, in May 2024, the FDA issued a final rule to amend its regulations to make explicit that LDTs are devices under the FDCA.

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.

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.

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Human cells, tissues, and cellular and tissue-based products

We currently operate a provider of donated reproductive tissue (eggs and sperm) for fertility treatments, fertility cryopreservation services and newborn stem cell storage.

We currently operate as a provider of donated reproductive tissue (eggs and sperm) for fertility treatments, fertility cryopreservation services and newborn stem cell storage.

Eggs and sperm are regulated by the FDA as human cells, tissues, and cellular and tissue-based products (HCT/Ps).

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In the United States, the FDA regulates pharmaceutical products under the FDCA and its implementing drug regulations.

The FDA has determined that the primary mode of action for PARAGARD is the drug component and is therefore regulated by the FDA’s Center for Drug Evaluation and Research as a drug product.

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, inspections and audits and compliance with post-approval requirements.

Any drug products manufactured or distributed by us pursuant to FDA 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.

Drug manufacturers and their subcontractors are required to be in compliance with Good Manufacturing Practices, or cGMPs, and other requirements.

Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

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.

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.

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.

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.

Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain ongoing compliance.

In addition, the FDA closely regulates the marketing, promotion and distribution of pharmaceutical products.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

Foreign Regulation

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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.

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.

The EU rules below are generally applicable in the European Economic Area (EEA) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland, while the majority of the United Kingdom now operates under a separate regulatory regime following the United Kingdom's withdrawal from the EU on January 31, 2020.

The ISO 13485 Quality Management System certification is now also required for registration of products in Asia Pacific and Latin American

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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.

Medical Device and In Vitro Diagnostic Medical Device Regulation in the EU

Until May 25, 2021, medical devices sold in the EU were regulated by the Medical Device Directive (the EU MDD), which has been repealed and replaced by the Medical Device Regulation (the EU MDR).

Similarly, the EU has adopted the In Vitro Diagnostic Medical Device Regulation (the EU IVDR), which repealed and replaced the In Vitro Diagnostic Medical Device Directive (the EU IVDD) and became applicable on May 26, 2022.

Until May 25, 2021, medical devices sold in the EU were regulated by the Medical Device Directive (the EU MDD), which has been repealed and replaced by the EU MDR).

Similarly, the EU has adopted the IVDR, which repealed and replaced the In Vitro Diagnostic Medical Device Directive (the EU IVDD) and became applicable on May 26, 2022.

The majority of our current certificates have been granted under the EU MDD and the EU IVDD.

Devices lawfully placed on the market pursuant to the EU MDD and EU IVDD may generally continue to be made available on the market or put into service provided that the requirements of transitional provisions are fulfilled.

Due to the unattainable nature of the deadlines for recertification of medical devices under the EU MDR and the EU IVDR, EU institutions have extended the transition periods for devices certified in accordance with the previous Directives, including the EU MDD and the EU IVDD, through legislative amendments of the transitional provisions of the EU MDR and EU IVDR.

Therefore, devices lawfully placed on the market pursuant to the EU MDD and EU IVDD may generally continue to be made available on the market or put into service provided that the requirements of transitional provisions are fulfilled.

Pursuing marketing of medical devices (including IVDs) in the EU will require that our devices be certified under the new regimes set forth in the EU MDR and the EU IVDR.

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.

A Declaration of Conformity to the Medical Device Directive (MDD) or Medical Device Regulation (MDR) is drawn out as a basis for European conformity marking (CE Mark).

A declaration of conformity to the MDD or 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.

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Laboratory Developed Test Regulation in the EU

In the EU, laboratory developed tests (LDTs) are exempt from the regulations that govern medical devices and IVDs under certain conditions.

In the EU, LDTs were exempt from the regulations that govern medical devices and IVDs under certain conditions.

In order to fall within this exemption under the EU IVDD, medical devices, including LDTs, had to be designed and used within such health institutions (which may include hospitals, laboratories and public health institutions that support the healthcare system and/or address patient needs but do not treat or care for patients directly) on a non-industrial scale, without being released into the market.

While the legal framework for applying the exemption under the EU IVDD to LDTs was not entirely clear, the EU IVDR may provide greater clarity on the regulation of LDTs.

Our current and future tests will need to be analyzed as to whether any or all of them would qualify for an exemption under EU IVDR;

otherwise, we will be required to comply with various certification and documentation criteria, and we may be subject to conformity assessments and inspections.

Our current and future tests will need to be assessed against the EU IVDR requirements.

We will be required to comply with various certification and documentation criteria, and we will be subject to conformity assessments and audits by EU notified body and inspections by regulatory authorities.

Medical Devices and In Vitro Diagnostic Medical Devices Regulations in the United Kingdom

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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).

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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.

However, the Government is currently developing substantial reforms to the Great Britain regulatory regime for medical devices and IVDs.

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However, substantial reforms to the Great Britain regulatory regime for medical devices and IVDs are currently being developed to improve patient safety.

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.

Medical Device and In Vitro Diagnostic Medical Device Regulation in Asia Pacific

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For example, in China, manufacturers must provide proof of home country approval (such as the United States or EU) as part of the regulatory registration/approval process.

The National Medical Products Administration (NMPA) regulates medical devices in China.

The NMPA regulates medical devices in China.

Medical devices in China are classified by risk into Class I (lowest risk), Class II or Class III (highest risk).

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• 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;

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• federal and state laws that prohibit executing, or attempting to execute, a scheme to obtain money from any healthcare benefit program under false pretenses;

• the Physician Payments Sunshine Act and similar state and foreign laws that require medical device and pharmaceutical manufacturers to disclose financial relationships with health care professionals and teaching hospitals;

• data privacy and security laws and regulations, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the EU General Data Protection Regulation (GDPR), which are intended to protect the collection, use, access to, confidentiality and security of health-related and other personal information.

• data privacy and security laws and regulations, such as the HIPAA and the EU GDPR, which are intended to protect the collection, use, access to, confidentiality and security of health-related and other personal information.

Coverage and Reimbursement

Market acceptance and sales of our CooperSurgical products to our customers, who primarily consist of hospitals and surgical 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-

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party payors.

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.

Payor coverage and reimbursement for procedures using medical devices in the United States and international markets vary significantly by country.

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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.

CYBERSECURITY

In the normal course of business, we may collect and store personal information and other sensitive information, including proprietary and confidential business information, trade secrets, intellectual property, information regarding trial participants in connection with clinical trials, sensitive third-party information and employee information.

To protect this information, our existing cybersecurity policies require continuous monitoring and detection programs, network security precautions, and in-depth security assessment of vendors.

We maintain various protections designed to safeguard against cyberattacks, including firewalls and virus detection software.

We have established and regularly test our disaster recovery plan and we protect against business interruption by backing up our major systems.

In addition, we periodically scan our environment for any vulnerabilities, perform penetration testing and engage third parties to assess effectiveness of our data security practices.

A third-party security consultant conducts regular network security reviews, scans and audits.

In addition, we maintain insurance that includes cybersecurity coverage.

Our cybersecurity program is led by a team of skilled cybersecurity professionals, including dedicated internal cybersecurity resources.

The security team currently has CISSP credentials, GIAC/SANS cybersecurity certificates, and other security and network certifications.

In addition to our internal security staff, we partner with various third-party security service providers to augment our staffing, expertise, and hours of operation.

The program incorporates industry-standard frameworks, policies and practices designed to protect the privacy and security of our sensitive information.

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program also includes a suite of security technologies and tools to implement and automate security protections for our networks, employees, and customers.

Our cybersecurity team reports to the Audit Committee quarterly on information security and cybersecurity matters, or as needed.

Our Audit Committee, which is comprised of several members from our Board of Directors, has oversight responsibility for our data security practices and we believe the committee has the requisite skills and visibility into the design and operation of our data security practices to fulfill this responsibility effectively.

See “Risk Factors – Risks Relating to Our Business” for additional information about the risks to our business associated with a breach or compromise to our information security systems.

RAW MATERIALS

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These include clinical training, digital marketing for the customer, e-commerce, telemarketing, social media, and journal advertisements.

CooperVision also invested in tools that allow our customers to offer their patients monthly purchase and delivery subscriptions.

In certain smaller countries, CooperVision often uses distributors and leverages our distributors' sales and marketing resources to attract major customers to CooperVision.

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CooperSurgical's products are marketed by a network of dedicated field sales representatives, independent agents 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, social media and collaborative efforts with professional organizations, telemarketing, direct mail and advertising in professional journals.

Since the addition of PARAGARD and cord blood and cord tissue storage services, CooperSurgical has also expanded its awareness campaigns to include direct-to-consumer elements including print, internet/social media, radio and television.

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.

Since the addition of donor gametes, Paragard and cord blood and cord tissue storage services, CooperSurgical has also expanded its awareness campaigns to include direct-to-consumer elements including print, internet/social media and radio.

INTELLECTUAL PROPERTY

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We also rely upon trade secrets, licenses, technical know-how and continuing technological innovation to develop and maintain our competitive position.

CooperVision, CooperSurgical, and other trade names, trademarks or service marks of Cooper and its subsidiaries appearing in this report are the property of Cooper and its subsidiaries.

CooperVision, CooperSurgical, and other trade names, trademarks or service marks of the Company and its subsidiaries appearing in this report are the property of the Company and its subsidiaries.

Trade names, trademarks and service marks of the other companies appearing in this report are the property of their respective holders.

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Business Segment Information of the Consolidated Financial Statements for additional information.

CooperVision and CooperSurgical net sales in the fiscal first quarter, which runs from November 1 through January 31, are typically lower than subsequent quarters, as patient traffic to practitioners' offices, fertility clinics, and hospitals/surgical centers for surgical procedures is less during the holiday season.

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CooperVision and CooperSurgical net sales in the fiscal first quarter, which runs from November 1 through January 31, are typically lower than subsequent quarters, as patient traffic to practitioners' offices, fertility clinics, and hospitals/surgery centers for surgical procedures is less during the holiday season.

HUMAN CAPITAL RESOURCES

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The chart below shows percentage of employees located in Americas, EMEA and Asia Pacific as of October 31, 2024.

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Diversity and Inclusion

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enhance our workplace and culture.

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Compensation and Benefits

We provide competitive compensation and benefits in order to attract and retain talent.

We regularly review our pay practices to confirm there are no significant pay disparities across gender or race, and we conduct an annual market assessments to provide consistency in rewards we offer.

We regularly review our pay practices to confirm there are no significant pay disparities across gender or race, and we conduct an annual market assessment to provide consistency in rewards we offer.

We have implemented robust processes for setting personal goals, individual development actions and review employees’ performance and pay on an annual basis.

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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).

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.

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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.

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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 1. Business