The Cooper Companies(COO) - 2024 Q4 - Annual Report

Product Portfolio and Market Presence - CooperVision's MiSight 1 day lens is the first and only FDA-approved product to slow myopia progression in children aged 8-12, also approved by China's NMPA in August 2021[24] - CooperVision operates in three primary regions: Americas, EMEA, and Asia Pacific, with major manufacturing facilities in Belgium, Costa Rica, Hungary, Puerto Rico, the UK, and the US[24][26] - CooperSurgical offers over 600 products and services in fertility and women's health, with major facilities in Costa Rica, the Netherlands, the UK, and the US[25] - CooperSurgical acquired Cook Medical assets, a fertility company specializing in sperm separation devices, and obp Surgical in fiscal 2024[40] - CooperVision's Biofinity brand is its highest-grossing product, offering monthly silicone hydrogel lenses in spherical, toric, and multifocal categories[30] - CooperSurgical's Paragard is the only FDA-approved non-hormonal IUD, preventing pregnancy for up to ten years[43] - CooperVision's MyDay and clariti 1 day brands offer single-use silicone hydrogel lenses, with MyDay being the softest line and clariti 1 day being the most affordable[31] - CooperSurgical's cryostorage services for cord blood and cord tissue are available in the US, Canada, and Australia[42] Research and Development - CooperVision's R&D focuses on new contact lens designs, myopia management, and manufacturing technologies, supported by 400 employees[63] - CooperSurgical's R&D activities focus on innovating and advancing products in fertility and women's health, including instruments, devices, and digital services[64] Regulatory Compliance and Approvals - The majority of CooperSurgical's products are classified as Class II medical devices, requiring premarket notification under Section 510(k) of the FDCA[68] - Class III medical devices, such as extended wear contact lenses, require extensive premarket testing and FDA approval[68] - A majority of the company's medical devices currently on the market have received FDA clearance through the 510(k) process or approval through the PMA process[71] - The FDA's Quality System Regulation (QSR) requires manufacturers to follow strict quality assurance procedures during the manufacturing process[72] - The FDA issued a final rule in May 2024 to phase out its general enforcement discretion approach for Laboratory Developed Tests (LDTs) over four years[75] - The company's genetic testing laboratory in New Jersey holds current certification under CLIA to perform testing[75] - The EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require recertification of medical devices, with extended transition periods for devices certified under previous directives[84] - Medical devices in the EU must meet general safety and performance requirements and undergo conformity assessment procedures to obtain a CE mark[85][86] - The UK's regulatory regime for medical devices and IVDs is undergoing reforms to align with EU MDR requirements, with unique requirements such as post-market surveillance and AI expected by mid-2025[93] - In Asia Pacific, regulatory approval timelines are lengthy and unpredictable, with some countries requiring proof of home country approval (e.g., US or EU) for product registration[94] - The NMPA in China requires in-country clinical trials for new medical device registrations, rather than relying on foreign clinical data[95] - In Japan, the PMDA requires local clinical trial data for novel medical devices, extending the approval timeline[96] - Japan and Australia participate in the Medical Device Single Audit Program, allowing acceptance of QMS audit reports from other regulatory authorities, including the FDA[97] Economic and Market Risks - The Inflation Reduction Act of 2022 mandates Medicare price negotiations for certain drugs starting in 2026, with price caps and rebates for inflation-exceeding price increases[103] - The company has a global workforce of over 16,000 employees, with 54% in the Americas, 41% in EMEA, and 5% in Asia Pacific as of October 31, 2024[116] - CooperVision and CooperSurgical experience lower net sales in the fiscal first quarter due to reduced patient traffic during the holiday season[115] - The company relies on sole suppliers for certain raw materials, including silicone hydrogel contact lenses and IVF products, which could lead to supply disruptions if alternative suppliers are needed[109] - CooperVision has expanded its sales capabilities with the addition of MiSight, including direct-to-consumer marketing campaigns[110] - CooperSurgical has enhanced its marketing efforts with direct-to-consumer campaigns for donor gametes, Paragard, and cord blood storage services[111] - The company faces risks from economic pressures, including inflation, labor cost increases, and currency fluctuations, which could impact manufacturing costs and revenues[133] - Inflation could materially impact the company's cost structure and revenue, potentially leading to increased costs and inability to raise prices sufficiently to keep up with inflation[135] - More than half of the company's net sales for fiscal years 2024 and 2023 were derived from outside the United States, with international sales expected to remain a significant portion of total net sales[136] - The company faces challenges in growing sales in emerging markets such as China, India, Russia, and Brazil due to regulatory restrictions, customer acceptance, and undeveloped distribution channels[139] - Economic and trade sanctions could restrict or prohibit the sale of certain products to specific governments, persons, entities, countries, and territories, potentially leading to fines and denial of export privileges[141] - Acquisitions and strategic transactions involve risks such as failure to achieve anticipated revenues, difficulties in integration, and potential loss of employees[142] - The company's manufacturing and distribution operations are vulnerable to disruptions, which could adversely affect its business, particularly in facilities located in Costa Rica, Hungary, Puerto Rico, the United Kingdom, and the United States[147][148] - Cybersecurity threats could disrupt the company's information technology systems, leading to potential loss of confidential data, financial harm, and reputational damage[152] - The company is implementing new enterprise resource planning (ERP) systems, which is a costly and complex process that could negatively affect financial accounting and reporting processes[155] - A material weakness in internal control over financial reporting related to IT general controls for CooperSurgical operations in the U.S. was identified, which could affect the accuracy of financial reporting and investor confidence[157][160] - Pricing pressure from competitors, customers, and changes in third-party coverage and reimbursement may adversely affect demand for the company's products and negatively impact operating results[161] - Increased competition and pricing pressure due to new market entrants, technologies, and competitive pricing strategies from established companies[162] - Potential inventory shortages due to reliance on independent suppliers for raw materials, packaging, and components[163] - Risk of supply chain disruption for silicone hydrogel contact lenses (e.g., MyDay, Biofinity, Avaira, clariti) due to dependency on few or sole suppliers[164] - Negative impact on supply chain and cost of goods from unanticipated price increases due to inflation or supply restrictions[165] - Risk of business impact if intellectual property rights are not adequately protected, including patents, trademarks, and trade secrets[166] - Potential for significant litigation costs and damages related to intellectual property disputes, including challenges to patents and trademarks[170][175] - Risk of product liability claims or recalls, particularly for direct-to-consumer products like stem cell storage and Paragard IUDs[180] - Market acceptance risk for new or existing products, particularly those reliant on future medical or therapeutic advancements[181] - Intense competition in the contact lens market from major players like Johnson & Johnson Vision Care, Alcon, and Bausch Health, with declining sales for older product lines[183] - Risk of product obsolescence due to rapid technological advancements in vision correction, fertility, and women's health markets[191] Environmental, Social, and Governance (ESG) Matters - The company faces risks related to environmental, social, and governance (ESG) matters, including compliance with evolving regulations and potential costs associated with environmental claims[197][199][200] - New ESG disclosure standards, such as the EU Corporate Sustainability Reporting Directive (CSRD) and California's carbon reporting requirements, may increase compliance costs and expose the company to potential litigation[199] - The company may incur additional manufacturing and product development costs due to changing customer preferences and regulatory requirements related to plastics, packaging, and sustainability[202] - Failure to meet ESG expectations could lead to reputational damage, loss of investor confidence, and reduced customer demand[201][205] Workforce and Operational Challenges - The company is experiencing challenges in workforce retention, particularly in markets with high inflation and competition, which could disrupt business operations[206] - Regulatory changes in the U.S. and EU, such as FDA reforms and the EU Medical Device Regulation (MDR), could delay product approvals and increase compliance costs[209][212][216] - Post-Brexit regulatory changes in the UK, including the need for medical device registration with the MHRA, may impact the company's ability to market products in the UK[217] - Product recalls and regulatory enforcement actions could harm the company's reputation and financial performance[218][219] - Compliance with FDA cGMP and QSR regulations is critical, and failure to meet these standards could result in manufacturing delays, fines, or product seizures[220]