Cooper Companies 10-K 2023-10-31
Filed 2023-12-08. 23 sections, 410K characters. Original on sec.gov · Markdown · JSON
Cover and table of contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________________________
FORM 10-K
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| ☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE FISCAL YEAR ENDED OCTOBER 31, 2023
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM TO
COMMISSION FILE NO. 001-08597
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THE COOPER COMPANIES, INC.
(Exact name of registrant as specified in its charter)
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| Delaware | 94-2657368 | ||||
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
6101 Bollinger Canyon Road,
Suite 500
San Ramon, California, 94583
(Address of principal executive offices) (Zip Code)
(925) 460-3600
(Registrant’s telephone number, including area code)
________________________
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||||||||||||
| Common Stock, $.10 par value | COO | Nasdaq Global Select Market |
Securities registered pursuant to Section 12(g) of the Act:
None
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Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes ☒ No ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements
of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant
to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of April 28, 2023, the last business day of registrant's most recently completed second fiscal quarter, the aggregate market value of shares of the registrant's common stock held by non-affiliates was $18.8 billion.
Number of shares outstanding of the registrant's common stock, as of December 1, 2023: 49,525,982
Documents Incorporated by Reference:
| Document | Part of Form 10-K | |||||||
| Portions of the Proxy Statement for the Annual Meeting of Stockholders scheduled to be held in March 2024 | Part III |
Our independent registered public accounting firm is KPMG LLP, San Francisco, CA, Auditor ID: 185.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Annual Report on Form 10-K
for the Fiscal Year Ended October 31, 2023
Table of Contents
| PART I | Page | |||||||
| Item 1. | Business | 7 | ||||||
| Item 1A. | Risk Factors | 19 | ||||||
| Item 1B. | Unresolved Staff Comments | 39 | ||||||
| Item 2. | Properties | 40 | ||||||
| Item 3. | Legal Proceedings | 41 | ||||||
| Item 4. | Mine Safety Disclosures | 41 | ||||||
| PART II | ||||||||
| Item 5. | Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 42 | ||||||
| Item 6. | Reserved | 43 | ||||||
| Item 7. | Management's Discussion and Analysis of Financial Condition and Results of Operations | 44 | ||||||
| Item 7A. | Quantitative and Qualitative Disclosure about Market Risk | 54 | ||||||
| Item 8. | Financial Statements and Supplementary Data | 55 | ||||||
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 88 | ||||||
| Item 9A. | Controls and Procedures | 88 | ||||||
| Item 9B. | Other Information | 88 | ||||||
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 88 | ||||||
| PART III | ||||||||
| Item 10. | Directors, Executive Officers and Corporate Governance | 89 | ||||||
| Item 11. | Executive Compensation | 89 | ||||||
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 89 | ||||||
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 89 | ||||||
| Item 14. | Principal Accounting Fees and Services | 89 | ||||||
| PART IV | ||||||||
| Item 15. | Exhibits and Financial Statement Schedules | 90 | ||||||
| Item 16. | Form 10-K Summary | 94 |
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
PART I
Forward-Looking Statements
This Annual Report on Form 10-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These include statements relating to plans, prospects, goals, strategies, future actions, events or performance and other statements which are other than statements of historical fact, including: statements regarding the expected impact of global macroeconomic conditions, and statements regarding acquisitions (including the acquired companies' financial position, market position, product development and business strategy, expected cost synergies, expected timing and benefits of the transaction, difficulties in integrating entities or operations, as well as estimates of our and the acquired entities' future expenses, sales and earnings per share) that are forward-looking. In addition, all statements regarding anticipated growth in our net sales, anticipated effects of any product recalls, anticipated market conditions, planned product launches and expected results of operations and integration of any acquisition are forward-looking. To identify these statements, look for words like “believes,” “outlook,” “probable,” “expects,” “may,” “will,” “should,” “could,” “seeks,” “intends,” “plans,” “estimates” or “anticipates” and similar words or phrases. Forward-looking statements necessarily depend on assumptions, data or methods that may be incorrect or imprecise and are subject to risks and uncertainties. Among the factors that could cause our actual results and future actions to differ materially from those described in forward-looking statements are those described in our Securities and Exchange Commission filings, including the “Business,” “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” sections in this Annual Report on Form 10-K for the fiscal year ended October 31, 2023, as such Risk Factors may be updated in quarterly filings.
We caution investors that forward-looking statements reflect our analysis only on their stated date. We disclaim any intent to update them except as required by law.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Summary Risk Factors
Our business faces significant risks. In addition to the summary below, you should carefully review the “Risk Factors” section of this Annual Report on Form 10-K. We may be subject to additional risks and uncertainties not presently known to us or that we currently deem immaterial. Our business, financial condition and results of operations could be materially adversely affected by any of these risks, and the trading prices of our common stock could decline by virtue of these risks. These risks should be read in conjunction with the other information in this report. Some of the more significant risks relating to our business include:
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Adverse changes in the global or regional general business, political and economic conditions, including the impact of continuing uncertainty and instability of certain countries, man-made or natural disasters and pandemic conditions, that could adversely affect our global markets, and the potential adverse economic impact and related uncertainty caused by these items.
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The impact of international conflicts, such as Russia's invasion of Ukraine, and the global response to international conflicts on the global economy, European economy, financial markets, energy markets, currency rates and our ability to supply product to, or through, affected countries.
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Our substantial and expanding international operations and the challenges of managing an organization spread throughout multiple countries and complying with a variety of legal, compliance and regulatory requirements.
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Foreign currency exchange rate and interest rate fluctuations including the risk of fluctuations in the value of foreign currencies or interest rates that would decrease our net sales and earnings.
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Our existing and future variable rate indebtedness and associated interest expense is impacted by rate increases, which could adversely affect our financial health or limit our ability to borrow additional funds.
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Changes in tax laws, examinations by tax authorities, and changes in our geographic composition of income.
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Acquisition-related adverse effects including the failure to successfully achieve the anticipated net sales, margins and earnings benefits of acquisitions, integration delays or costs and the requirement to record significant adjustments to the preliminary fair value of assets acquired and liabilities assumed within the measurement period, required regulatory approvals for an acquisition not being obtained or being delayed or subject to conditions that are not anticipated, adverse impacts of changes to accounting controls and reporting procedures, contingent liabilities or indemnification obligations, increased leverage and lack of access to available financing (including financing for the acquisition or refinancing of debt owed by us on a timely basis and on reasonable terms).
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Compliance costs and potential liability in connection with U.S. and foreign laws and health care regulations pertaining to privacy and security of personal information, such as HIPAA and the California Consumer Privacy Act (CCPA) in the U.S. and the General Data Protection Regulation (GDPR) requirements in Europe, including but not limited to those resulting from data security breaches.
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A major disruption in the operations of our manufacturing, accounting and financial reporting, research and development, distribution facilities or raw material supply chain due to challenges associated with integration of acquisitions, man-made or natural disasters, pandemic conditions, cybersecurity incidents or other causes.
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A major disruption in the operations of our manufacturing, accounting and financial reporting, research and development or distribution facilities due to technological problems, including any related to our information systems maintenance, enhancements or new system deployments, integrations or upgrades.
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Market consolidation of large customers globally through mergers or acquisitions resulting in a larger proportion or concentration of our business being derived from fewer customers.
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Disruptions in supplies of raw materials, particularly components used to manufacture our silicone hydrogel lenses
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New U.S. and foreign government laws and regulations, and changes in existing laws, regulations and enforcement guidance, which affect areas of our operations including, but not limited to, those affecting the health care industry, including the contact lens industry specifically and the medical device or pharmaceutical industries generally, including but not limited to the EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR).
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Legal costs, insurance expenses, settlement costs and the risk of an adverse decision, prohibitive injunction or settlement related to product liability, patent infringement, contractual disputes, or other litigation.
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Limitations on sales following product introductions due to poor market acceptance.
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New competitors, product innovations or technologies, including but not limited to, technological advances by competitors, new products and patents attained by competitors, and competitors' expansion through acquisitions.
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Reduced sales, loss of customers and costs and expenses related to product recalls and warning letters.
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Failure to receive, or delays in receiving, regulatory approvals or certifications for products.
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Failure of our customers and end users to obtain adequate coverage and reimbursement from third-party payers for our products and services.
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The requirement to provide for a significant liability or to write off, or accelerate depreciation on, a significant asset, including goodwill, other intangible assets and idle manufacturing facilities and equipment.
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The success of our research and development activities and other start-up projects.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
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Dilution to earnings per share from acquisitions or issuing stock.
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Impact and costs incurred from changes in accounting standards and policies.
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Risks related to environmental laws and requirements applicable to our facilities, products or manufacturing processes, including evolving regulations regarding the use of hazardous substances or chemicals in our products.
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Risks related to environmental, social and corporate governance (ESG) issues, including those related to climate change and sustainability.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Item 1. . Business.
OVERVIEW
The Cooper Companies, Inc. (Cooper, we or the Company), is a global medical device company with a mission to improve lives one person at a time. We partner with health care providers worldwide to improve patient outcomes and deliver practice-building resources and training. 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.
Cooper operates through two business segments, CooperVision and CooperSurgical. Our two business segments elevate standards of care with products and services in the fields of vision, fertility and women’s health. For financial information relating to these business segments, refer to Note 12. Business Segment Information in Item 8. Financial Statements and Supplementary Data of this Annual Report.
CooperVision is a global manufacturer providing products for contact lens wearers. CooperVision develops, manufactures and markets a broad range of single-use, two-week and monthly contact lenses, featuring advanced materials and optics. CooperVision designs its products to address vision challenges such as astigmatism, presbyopia and myopia with a broad collection of spherical, toric and multifocal contact lenses. CooperVision offers contact lenses in materials like silicone hydrogel Aquaform technology. 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. 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. 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.
CooperSurgical offers a broad array of products and services focused on fertility and women's health. 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); 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). CooperSurgical has established its market presence and distribution system by developing products and acquiring companies, products and services that complement its business model. CooperSurgical's major manufacturing, cryostorage and distribution facilities are located in Costa Rica, the Netherlands, the United Kingdom and the United States, with other smaller facilities in multiple locations around the world.
SEGMENT INFORMATION
CooperVision
CooperVision competes in the worldwide soft contact lens market and services three primary regions: the Americas, EMEA (Europe, Middle East and Africa) and Asia Pacific. The two major product categories of contact lenses sold by CooperVision are:
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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.
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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.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
CooperVision Product Modalities
Frequent replacement lenses
Under the Biofinity brand, CooperVision markets monthly silicone hydrogel spherical (including Biofinity Energys), toric, multifocal and toric multifocal (made-to-order) lens products. Our Biofinity brand is CooperVision's highest grossing product. CooperVision also markets two-week silicone hydrogel spherical and toric lenses under the Avaira Vitality brand.
Single-use lenses
CooperVision markets single-use silicone hydrogel lenses under our MyDay brand and our clariti 1 day brand. The MyDay brand is our softest 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. CooperVision also offers traditional single-use hydrogel lenses under our Proclear and Biomedics brands.
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
The market for spherical lenses is growing with the addition of new value-added products, such as spherical lenses that may provide improved comfort for contact lens related dryness during lens wear and that add aspherical optical properties, more higher oxygen permeable lenses such as silicone hydrogels, and myopia management contact lenses for children aged 8 to 12 years old. CooperVision believes that there are opportunities for contact lenses to gain market share, particularly in markets where the penetration of contact lenses in the vision correction market is low.
We believe that myopia management opens up an attractive new market for contact lenses. With MiSight, we offer the only FDA approved1 and first Chinese NMPA approved product 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.
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
CooperSurgical focuses on advancing fertility and women's health through a diversified portfolio including fertility products and services, medical devices, cryostorage (such as cord blood and cord tissue storage) and contraception. We offer quality products, innovative technologies and superior services to health care professionals and patients worldwide. CooperSurgical collaborates with health care professionals to identify products and new technologies to bring to market. 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.
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. 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.
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. The lens is to be discarded after each removal.
THE COOPER COMPANIES, INC. 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). 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.
CooperSurgical Product Categories
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. Our newborn stem cell storage services are available in the United States, Canada and Australia.
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. It is the only FDA approved non-hormonal IUD contraceptive option and is exclusively sold in the United States.
Fertility
CooperSurgical has broad product offerings for fertility evaluations and IVF procedures by OB/GYN professionals, reproductive endocrinologists and embryologists. In fertility clinics, our products include media, micro-tools and lab equipment. Additionally, CooperSurgical offers services to clinics and families undergoing assisted reproductive technologies including donor gametes, cryostorage, and genomic services.
Market for Fertility and Women's Health Care
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. As the consolidation trend continues it will have increased influence over supply chain control, group purchases, value analysis committees, product evaluation and procurement. We believe CooperSurgical's broad product portfolio can benefit in this changing environment as customers look to standardize and consolidate vendors.
Trends specific in the OB/GYN market include:
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The increase in office-based and outpatient procedures, given high patient satisfaction, reduction of healthcare costs and comparative clinical outcomes.
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A focus on reducing pregnancy and childbirth complications.
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The obstetrician being a key contributor to stem cell storage, facilitating the collection of cord blood and cord tissue following delivery in most markets.
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Initial evaluation and treatments for infertility, such as uterine assessment, ovulatory medications and intrauterine insemination (IUI), beginning with the OB/GYN and then transitioning to fertility clinics.
Trends specific in the fertility market include:
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Infertility rates are increasing globally, and there is a significant unmet need for fertility products and services.
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The maternal age is increasing.
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Patient awareness of, and access to, services is increasing.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
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The number of fertility clinics is rising worldwide.
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Single parents by choice and LGBTQIA+ individuals are starting families.
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Improved product offerings such as donor activity and cryopreservation services are becoming available.
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Technology improvements are being developed for both male and female infertility challenges.
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Worldwide disposable income is increasing.
COMPETITION
The markets in which we participate are highly competitive and involve the continual search for technological and scientific innovations. Competitive factors in these markets include technological and scientific advances, product quality and availability, price, customer service including response time and effective communication of product information to clinicians and consumers, and manufacturing processes. Competitors may have greater financial resources, larger research and development budgets, larger sales forces, greater market penetration and/or larger manufacturing capacity. Both CooperVision and CooperSurgical compete predominantly on the basis of product quality and differentiation, technological benefits, price, service levels and reliability.
CooperVision Competition
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. and Bausch + Lomb. To a lesser extent, CooperVision also competes with manufacturers of eyeglasses and providers of other forms of vision correction including ophthalmic surgery. We believe that in order to compete successfully in the numerous categories of the contact lens market, companies must offer differentiated products that are priced competitively and manufactured efficiently. CooperVision competes in its markets by producing high, medium and low-volume lenses made with a variety of materials for a broader range of market niches, as well as offering a wide range of lens parameters, leading to a higher rate of successful fitting for practitioners and better visual acuity for patients. Our ability to compete successfully with a full range of silicone hydrogel products is an important factor to achieving success in our business. We also compete based on our customer and professional services.
CooperSurgical Competition
CooperSurgical focuses on selected segments of the fertility and women's health care market with a diversified portfolio including fertility products and services, medical devices, cryostorage (such as cord blood and cord tissue storage) and contraception. 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. We also compete with fertility clinics offering their own services. Larger companies such as Johnson & Johnson, Medtronic and Hologic have offerings that compete with our medical device products. 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. We are aware of a non-hormonal IUD under development, which may compete with PARAGARD in the future.
RESEARCH AND DEVELOPMENT
The Company employs approximately 400 people in research and development. CooperVision's product development and clinical research is supported by internal and external specialists in lens design, formulation science, polymer chemistry, engineering, clinical trials, microbiology and biochemistry. CooperVision's research and development activities primarily include programs to develop new contact lens designs, myopia management, and manufacturing technologies, along with improving formulations and existing products.
CooperSurgical conducts research and development in-house, and works with external specialists when necessary, in mechanical, electrical, biomedical and software engineering, as well as life sciences. 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.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
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. 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. 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. Failure to comply with the applicable regulations, which are subject to established and new legislation and change, could result in enforcement action by the FDA, or other U.S. or foreign government agencies which may include, among other things, any of the following consequences: warning letters, civil penalties, refusal or withdrawal of approvals or certifications, license suspension or revocation, product recalls, operating restrictions, suspension or shutdown of production, and criminal prosecution.
Regulation in the United States
Medical 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. The FDA classifies medical devices into one of three classes—Class I, II or III—depending on the degree of risk associated with each medical device and the extent of control needed to ensure the medical device's safety and effectiveness. Both CooperVision and CooperSurgical develop and market medical devices subject to different levels of FDA regulation depending on the classification and risk profile of the device. Class III devices, such as extended wear contact lenses, require extensive premarket testing and approval, while Class I and II devices require lower levels of regulation. The majority of CooperSurgical's products are Class II devices. Unless an exemption applies, each medical device we wish to distribute commercially in the United States will require either premarket notification to the FDA requesting clearance for commercial distribution under Section 510(k) of the FDCA, a premarket approval (PMA) from the FDA, or a de novo classification and request for marketing authorization submitted to and granted by the FDA.
If we are required to obtain a 510(k) clearance for a device that we wish to market, we must submit a premarket notification to the FDA demonstrating that the device is substantially equivalent to a device commercially distributed in the United States before May 28, 1976 (a pre-amendments device), or to a device that was found to be substantially equivalent to a pre-amendments device. If the FDA agrees that the device is substantially equivalent, it will grant 510(k) clearance to commercially market the device. If the FDA determines that the device is not substantially equivalent to a legally marketed device, the FDA automatically designates the device as a Class III device. The sponsor of a device automatically designated as Class III must either fulfill more rigorous PMA requirements or request a risk-based classification determination for the device in accordance with the de novo process. The de novo process is a pathway to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.
A PMA application must be submitted if the device cannot be cleared through the 510(k) premarket notification procedures, or if the device has been previously classified as Class III. The PMA process is much more demanding than the 510(k) premarket notification process. A PMA application must be supported by extensive data including, but not limited to, technical, pre-clinical, clinical trials, manufacturing and labeling to demonstrate to the FDA's satisfaction the safety and effectiveness of the device for its intended use. Prior to commencing human clinical trials, submission of an application for an investigational device exemption (IDE) and receipt of IDE approval from the FDA is required if the device under evaluation presents a significant risk to human health. The process of gathering supporting information leading up to PMA application, and the subsequent FDA review, can take several years.
A majority of the medical devices we currently market have received FDA clearance through the 510(k) process or approval through the PMA process. Because we cannot be assured that any new products we develop, or any product enhancements, will be exempt from the premarket clearance or approval requirements, or will be subject to the shorter 510(k) clearance process rather than the PMA process, significant delays in the introduction of any new products or product enhancements may occur.
After a device is placed on the market, numerous regulatory requirements apply. These include: establishment registration and device listing with the FDA; the FDA's Quality System Regulation (QSR), which requires manufacturers to follow design, testing, production, control, complaint handling, documentation and other quality assurance procedures during the manufacturing process; labeling regulations, which prohibit the promotion of products for uncleared or unapproved or “off-label” uses and impose other restrictions on labeling, advertising and promotion; FDA unique device identifier regulations, which require changes to labeling and packaging; 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
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
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. 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. 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. 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.
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. Eggs and sperm are regulated by the FDA as human cells, tissues, and cellular and tissue-based products (HCT/Ps). In addition, Section 361 of the Public Health Service Act (PHSA) authorizes the FDA to issue regulations with respect to HCT/Ps. To be regulated as a "361 HCT/P", the product must, among other things, be minimally manipulated and intended only for homologous uses. HCT/Ps regulated as 361 HCT/Ps are subject to requirements relating to registering facilities and listing products with the FDA, and stringent requirements for processing, storing, labeling and distributing HCT/Ps, including required labeling information, screening and testing for tissue donor eligibility, record keeping and adverse event reporting, among other applicable requirements and laws. 361 HCT/Ps do not require 510(k) clearance, PMA approval, submission of a Biologics License Application, or other premarket authorization from the FDA before marketing. We believe our HCT/Ps are regulated as 361 HCT/Ps.
Pharmaceutical Products
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. In addition, the FDA closely regulates the marketing, promotion and distribution of pharmaceutical products.
Foreign Regulation
Health authorities in foreign countries regulate Cooper's clinical studies and medical device sales. Even if the FDA has cleared or approved a product in the United States, the regulatory agencies or notified bodies in other countries must approve or certify new products and product modifications before they may be marketed in those countries. The regulations vary widely from country to country, although there is a trend towards harmonization of quality system standards among the European Union (EU), United States, Canada and various other industrialized countries. Medical devices marketed or sold in the EU must meet the CE mark requirements and maintain certain certifications. 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 COOPER COMPANIES, INC. AND SUBSIDIARIES
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. 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. 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). 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. Medical devices must be safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.
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. 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. 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. Typically, satisfactory completion of an audit and examinations of a product’s technical dossiers and the manufacturer’s quality system is required before the issuance of a certificate by the notified body. This certificate, along with the Declaration of Conformity, are then used by the manufacturer as basis for CE mark.
Throughout the term of the certificate, the manufacturer will be subject to periodic surveillance audits to verify continued compliance with the applicable requirements.
In addition, all manufacturers placing medical devices on the market in the EU are subject to various other regulations, including compliance with the EU medical device vigilance system, directives and requirements regarding the advertisement and promotion of medical devices and inspections rights of regulatory authorities.
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 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.
Medical Devices and In Vitro Diagnostic Medical Devices Regulations in the United Kingdom
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.
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.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Medical Device and In Vitro Diagnostic Medical Device Regulation in Asia Pacific
As in other regions, securing regulatory approvals in Asia Pacific is a critical aspect of commercializing our products. While medical device regulations in the Asia Pacific are based on similar regulatory fundamentals (such as risk-based classification of devices) as other regions, navigating the regulatory landscape in Asia Pacific is extremely complex. Medical device regulation in Asia Pacific differs significantly country by country, requiring specific regulatory affairs expertise in each country, as well as country-based regulatory strategies. The regulatory framework maturity in Asia Pacific is widely varied ranging from well-established to emerging, approval timelines can be lengthy and unpredictable and there is less access to and engagement with regulators compared to other markets. Several key Asia Pacific markets require regulatory approval in other countries prior to registration, increasing the time from completion of product development to product launch. 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. Medical devices in China are classified by risk into Class I (lowest risk), Class II or Class III (highest risk). China requires physical testing (known as ‘type testing’) of medical device samples by in-country testing centers to confirm compliance with specifications and standards, both pre- and post-market. Additionally, NMPA generally requires in-country clinical trials to support new product registrations, rather than relying on foreign clinical data.
In Japan, the primary regulation governing medical devices is the Pharmaceutical and Medical Device Act (PMD Act). The Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceutical and Medical Device Agency (PMDA) regulate medical devices. The PMDA evaluates the safety and effectiveness of medical devices prior to granting marketing authorization or approval, and monitors post-market safety of approved devices. The PMDA is also the Quality Management System (QMS) Inspection Authority. Medical devices are placed into one of four risk classes based on potential risk, with Class I being the lowest potential risk and Class IV being the highest. Contact lenses, for example, are regulated as Class III devices and require premarket approval (registration), an expensive and lengthy process depending on the application category. A novel or new medical device application will generally require local clinical trial data, extending the time to approval. The registration process in Japan requires a QMS application and inspection. Additionally, separate from the registration process, a Foreign Manufacturer Registration is required before a company can import medical devices manufactured outside Japan.
Japan and Australia participate in the Medical Device Single Audit Program, which allows for the acceptance of QMS audit reports from other participating Regulatory Authorities, including the FDA.
Other Health Care Regulation
We are subject to various federal, state and foreign laws to prevent fraud and abuse in the healthcare industry and protect personal health-related information, including the following:
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state, federal and similar foreign anti-kickback laws, which generally prohibit payments and other forms of remuneration to induce or in return for the purchase, lease, order or arranging for the purchase, lease or order of a product or service;
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the federal physician self-referral law, known as the Stark Law, which generally prohibits physicians from referring Medicare or Medicaid patients to receive designated health services from an entity which the physician, or a member of the physician's immediate family, has a financial interest in;
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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;
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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; and
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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.
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-
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
party payors. Payor coverage and reimbursement for procedures using medical devices in the United States and international markets vary significantly by country. With respect to drug coverage and reimbursement, third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of drugs, in addition to their safety and efficacy. 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.
Healthcare Reform
In the United States and foreign countries, there has been, and continues to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect the profitable sale of product candidates. We expect that additional state, federal and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that state, federal and foreign governments will pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressures.
Among policy makers and payors in the United States, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. Passed in March 2010, the Patient Protection and Affordable Care Act (the ACA) substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical, medical device and clinical laboratory industries. 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. Most recently, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law. 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; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
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.
Other Laws and Regulations
We are subject to numerous federal, state, local and foreign environmental laws, including provisions that regulate the discharge of materials into the environment, laws applicable to our facilities, products or manufacturing processes, including evolving regulations regarding the use of hazardous substances or chemicals in our products, and laws related to the protection of the environment, environmental health and safety regulations, Restriction of Hazardous Substances (RoHS) in electrical and electronic equipment in the EU, and Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH).
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. The
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
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
Our businesses utilize various chemicals, packaging materials, components, parts and raw materials which are generally available from more than one source. 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. Supply of these materials 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.
MARKETING AND DISTRIBUTION
CooperVision markets our products through our own field sales representatives, distributors and eye care practitioners, including optometrists, ophthalmologists, opticians and optical chains. CooperVision also sells to distributors and to mass merchandisers who offer eye care services. To support the sale and use of CooperVision products, CooperVision engages in various activities and offers a variety of services. 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. 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.
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.
INTELLECTUAL PROPERTY
We protect our products through patents and trademark registrations, both in the United States and in international markets. We monitor competitive products trademark use worldwide and, when determined appropriate, we have enforced and plan to continue to enforce and defend our patent and trademark rights. 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. Trade names, trademarks and service marks of the other companies appearing in this report are the property of their respective holders.
DEPENDENCE ON CUSTOMERS
No customer accounted for 10% or more of our consolidated net revenue in fiscal 2023 and 2022. See Note 12. Business Segment Information of the Consolidated Financial Statements for additional information.
SEASONALITY
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.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
HUMAN CAPITAL RESOURCES
As of October 31, 2023, we had a workforce of more than 15,000. Our employees are located around the world, with 53% in Americas, 42% in EMEA and 5% in Asia Pacific. Human capital management areas of focus include a people-focused culture; embedding diversity and inclusion; fostering an environment of health, safety, and well-being; investing in and developing our employees through training and engagement. Our employees are a key differentiator in our overall strategy. 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.
The Chart below shows percentage of employees located in Americas, EMEA and Asia Pacific as of October 31, 2023.

Diversity and Inclusion
We believe that an inclusive work environment that truly appreciates the diversity of employees’ talents, experiences, and ideas leads to more innovation and progress. 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. 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. Our commitment to D&I starts with our executives and is further executed through local initiatives in order to create sustainable change.
Health, Safety and Well-being
Our culture of health, safety, and well-being helps our people and businesses thrive. We comply with applicable health and safety laws and regulations and help protect our employees through continuous improvement, education, engagement, and risk management. Our Environmental, Health, and Safety (EHS) Global Policies formalize our commitment to high standards of EHS performance for employees, consultants, contract workers, and temporary staff worldwide. Our employee handbooks specify health and safety expectations, working condition policies, and other relevant topics. We encourage an open reporting culture and require any unsafe conditions or potential hazards be reported immediately. Wellness is an important part of our culture. Our global Mind & Body Well-being Employee Resource Group focuses on enhancing physical wellness and raising the importance of mental health through virtual and in-person events. We offer on- and off-site fitness and wellness facilities and programs, an assortment of team-building activities, and have a robust offering of physical, social, nutritional and mental health resources.
Training, Development and Engagement
We empower employees to succeed and grow, reward great thinking, results and hard work, and engage our employees. Across our businesses, we offer job-specific training, certifications, mentoring, developmental assignments, and other opportunities to help our employees develop the skills needed to achieve long-term success.
We conduct regular formal and informal surveys to proactively seek out employee feedback, ideas, and collect data on
the employee experience. We encourage candid participation, and these insights help us develop targeted strategies to
enhance our workplace and culture.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
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 have implemented robust processes for setting personal goals, individual development actions and review employees’ performance and pay on an annual basis. We also offer comprehensive and continually evolving benefits to help employees balance their work lives and personal lives.
AVAILABLE INFORMATION
The Cooper Companies, Inc. Internet address is https://www.coopercos.com. 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. The SEC maintains a website that contains such reports, proxy and information statements and other information whose Internet address is https://www.sec.gov. The Company's Corporate Governance Principles, Code of Conduct and charters of each standing committee of the Board of Directors are also posted on the Company's website.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Item 1A. Risk Factors.
Our business faces significant risks. These risks include those described below and may include additional risks and uncertainties not presently known to us or that we currently deem immaterial. Our business, financial condition and results of operations could be materially adversely affected by any of these risks, and the trading prices of our common stock could decline by virtue of these risks. These risks should be read in conjunction with the other information in this report.
Risks Relating to Our Business
Current market conditions and recessionary pressures in one or more of our markets could impact our ability to grow our business.
Over the last few years in the United States and globally, market and economic conditions have been challenging. The United States and foreign countries have experienced recessionary pressures and face continued concerns about the systemic impacts of adverse economic conditions and geopolitical issues. Any negative impact on economic conditions and international markets, continued volatility or deterioration in the debt and equity capital markets, inflation, deflation or other adverse economic conditions may adversely affect our liquidity and financial condition. It may limit our ability to replace maturing liabilities and to access the capital markets to meet liquidity needs, which could have a material adverse effect on our business.
Ongoing uncertain economic and financial market conditions may also adversely affect the financial condition of our customers, suppliers and other business partners. When our customers’ financial conditions are adversely affected, customers may reduce their purchases of our products or we may not be able to collect accounts receivable, each of which could have a material adverse impact on our business. Our global business has been negatively affected by local economic conditions, including inflation, increasing labor costs, recession, and currency exchange rate fluctuations, which has adversely affected our cost to manufacture and provide our products and services and revenues generated through sales of such products and services. We cannot guarantee that we will be able to fully absorb any such additional costs or revenue declines in the prices for our products and services.
CooperVision and CooperSurgical are encountering consolidation in their customer bases and emergence of more centralized large customer groups and retail chains. Due to this trend, global and regional key account customers now represent a larger proportion or concentration of our business and any disruption to these relationships may have a material adverse impact on our business.
Inflation could materially adversely affect our business.
Our operating results could be materially impacted by changes in the overall macroeconomic environment and other economic factors that impact our cost structure and revenue. Changes in economic conditions, supply chain constraints, logistics challenges, labor shortages, the war in Ukraine and other international conflicts, and steps taken by governments and central banks, as well as other stimulus and spending programs, have led to higher inflation, which is likely to lead to an increase in costs and may cause changes in fiscal and monetary policy, including increased interest rates. In a higher inflationary environment, we may be unable to raise the prices of our products and services sufficiently to keep up with the rate of inflation.
Our substantial and expanding international operations are subject to uncertainties which could affect our business.
A significant portion of our current operations are conducted and located outside the United States, and our growth strategy involves expanding our existing foreign operations and entering into new foreign jurisdictions. We have significant manufacturing and distribution sites in North America, Latin America and Europe. More than half of our net sales for the fiscal years ended October 31, 2023 and 2022, were derived from the sale of products outside the United States. We believe that sales outside the United States will continue to account for a material portion of our total net sales for the foreseeable future. International operations and business expansion plans are subject to numerous additional risks, including the following:
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difficulty managing a large organization spread throughout various countries;
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fluctuations in currency exchange rates adversely affecting our results;
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challenges associated with enforcing intellectual property rights in some foreign countries;
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difficulty gaining market share in countries such as China because of regulatory restrictions and customer preferences;
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
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difficulty growing our sales in emerging markets such as China, India, Russia, Brazil and other developing nations due to, among other things, customer acceptance, undeveloped and/or unfamiliar distribution channels, regulatory restrictions and changes, and business knowledge of these new markets;
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foreign earnings being subject to withholding requirements or the imposition of tariffs, exchange controls or other restrictions, including the tariffs enacted by the Chinese government on certain U.S. goods, the scope and duration of which remain uncertain;
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challenges in complying with a variety of international legal, compliance and regulatory requirements such as the Foreign Corrupt Practices Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the UK Bribery Act, international data security and privacy laws, EU MDR and EU IVDR. and environmental laws and requirements applicable to our facilities, products or manufacturing processes, including evolving regulations regarding the use of hazardous substances or chemicals in our products.
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foreign customers creating longer payment cycles than customers in the United States;
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failure to comply with U.S. Department of Commerce and other nations' import-export controls may result in fines and/or penalties;
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general economic and political conditions in the countries where we operate having an adverse effect on our operations in those countries or being unfavorable to our growth strategy;
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natural disasters, pandemics, war, terrorism, labor disruptions and international conflicts may cause significant economic disruption and political and social instability, resulting in decreased demand for our products, adversely affecting our manufacturing and distribution capabilities, or causing interruptions in our supply chain;
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foreign governments adopting regulations, including those similar to the EU MDR and EU IVDR or take other actions that would have a direct or indirect adverse impact on our business and market opportunities, including but not limited to increased enforcement of potentially conflicting and ambiguous anti-bribery and privacy laws;
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challenges enforcing agreements and collecting receivables through some foreign legal systems; and
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unforeseen economic or political events in certain countries that may have an impact on our customers' ability or preferences to buy our products.
As we continue to expand our business globally, our success will depend, in large part, on our ability to anticipate and effectively manage these and other risks associated with our international operations. However, any of these factors could adversely affect our international operations and, consequently, our business.
International Conflicts, such as the war between Russia and Ukraine, could adversely affect our business.
On February 24, 2022, Russian military forces launched a military action in Ukraine. The military conflict is ongoing and the length, impact, and outcome is highly unpredictable. It has led and could continue to lead to significant market and other disruptions, including significant volatility in commodity prices and supply of energy resources, instability in financial markets, su
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Item 1B. Unresolved Staff Comments.
None.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Item 2. Properties.
The following is a summary of Cooper's principal facilities as of October 31, 2023. We generally lease our office and operations facilities but own several manufacturing and research and development facilities, including 303,872 square feet in the United Kingdom, 347,329 square feet in Costa Rica, 115,000 square feet in Puerto Rico, 493,833 square feet in New York, 80,000 square feet in Arizona and 34,453 square feet in Texas. The following table lists those properties that we lease. Our lease agreements expire at various dates through the year 2045. We believe our properties are suitable and adequate for our businesses.
| Location | Approximate Leased Square Feet | Operations | |||||||||
| AMERICAS | |||||||||||
| United States: | |||||||||||
| California | 200,140 | Executive offices; CooperVision manufacturing, research & development and administrative offices; CooperSurgical research & development, distribution and administrative offices | |||||||||
| New York | 132,813 | CooperVision and CooperSurgical distribution and administrative offices | |||||||||
| New Jersey | 37,700 | CooperSurgical research and development, distribution and administrative offices | |||||||||
| Connecticut | 275,337 | CooperSurgical distribution and administrative offices | |||||||||
| Arizona | 45,000 | CooperVision manufacturing and distribution | |||||||||
| Puerto Rico | 740,954 | CooperVision manufacturing, research and development and distribution | |||||||||
| Canada | 63,836 | CooperVision manufacturing and administrative office; CooperSurgical research & development, distribution and administrative offices | |||||||||
| Brazil | 22,048 | CooperVision distribution and administrative office | |||||||||
| Other Americas | 58,365 | CooperVision distribution and administrative offices; CooperSurgical research & development, distribution and administrative offices | |||||||||
| EMEA | |||||||||||
| United Kingdom | 667,384 | CooperVision manufacturing, distribution, research & development and administrative offices; CooperSurgical research & development, administrative offices | |||||||||
| Hungary | 330,245 | CooperVision manufacturing | |||||||||
| Belgium | 282,108 | CooperVision distribution | |||||||||
| Spain | 181,145 | CooperVision distribution and administrative office; CooperSurgical administrative office | |||||||||
| Netherlands | 279,288 | CooperVision administrative offices; CooperSurgical research & development and distribution | |||||||||
| Other EMEA | 148,980 | CooperVision distribution and administrative offices; CooperSurgical administrative offices | |||||||||
| ASIA PACIFIC | |||||||||||
| Japan | 109,163 | CooperVision distribution and administrative offices; CooperSurgical laboratory/research & development | |||||||||
| Australia | 40,139 | CooperVision marketing and distribution; CooperSurgical research & development and distribution | |||||||||
| Other Asia Pacific | 92,517 | CooperVision distribution, marketing and administrative offices; CooperSurgical marketing and administrative office |
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Item 3. Legal Proceedings.
Information regarding legal proceedings is included in Note 11. Contingencies of the Consolidated Financial Statements.
Item 4. Mine Safety Disclosures.
Not applicable.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
PART II
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Cooper's common stock, par value $0.10 per share, is traded on the Nasdaq under the symbol “COO.” Prior to September 26, 2023, Cooper's common stock traded on the New York Stock Exchange under the symbol "COO". At December 1, 2023, there were 256 common stockholders of record.
Dividend Policy
In the past, we have paid annual cash dividends on our common stock of $0.06 per share, in two semiannual payments of $0.03 per share each. In dollar terms, we paid cash for dividends of $3.0 million in each of fiscal 2023 and 2022. Dividends are paid when, as and if declared at the discretion of our Board of Directors from funds legally available for that purpose. Our Board of Directors considers the Company's earnings, financial condition, liquidity needs, business plans and opportunities and other factors in determining whether to declare a dividend. In December 2023, our Board of Directors decided to end the declaration of the semiannual dividend.
Performance Graph
The following graph compares the cumulative total return on Cooper's common stock with the cumulative total return of the Standard & Poor 500 and the Standard & Poor's Health Care Equipment Index for the five-year period ended October 31, 2023. The graph assumes that the value of the investment in Cooper and in each index was $100 on October 31, 2018, and assumes that all dividends were reinvested.
COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among The Cooper Companies, Inc.,
the S&P 500 Index and the S&P Health Care Equipment Index

*$100 invested on October 31, 2018, in stock or index, including reinvestment of dividends.
Fiscal year ending October 31.
Copyright© 2023 Standard & Poor's, a division of S&P Global. All rights reserved.
Issuer Purchases of Equity Securities
There was no share repurchase activity during the three-month period ended October 31, 2023.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Equity Compensation Plan Information
The following table sets forth certain information as of October 31, 2023, concerning the shares of our Common Stock that may be issued under any form of award granted under our equity compensation plans in effect as of October 31, 2023:
| Plan Category | Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights**(1)** (A) | Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights**(2)** (B) | Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column A) (C) | ||||||||||||||
| Equity compensation plans approved by shareholders(3) | 1,505,841 | $277.29 | 2,325,881 | ||||||||||||||
| Equity compensation plans not approved by shareholders | — | — | — | ||||||||||||||
| Total | 1,505,841 | $277.29 | 2,325,881 |
(1) Includes (i) 290,029 shares subject to outstanding Restricted Stock Units (RSU), (ii) 138,256 shares subject to Performance Share Units (PSU), calculated at the maximum potential payout and (iii) 1,077,556 shares subject to outstanding options. Does not include rights to purchase shares under the 2019 Employee Stock Purchase Plan (2019 ESPP).
(2) The weighted-average exercise price is calculated based solely on the exercise prices of outstanding options and do not reflect shares to be issued upon the vesting of RSUs and PSUs, which have no exercise price.
(3) Includes information with respect to the Third Amended and Restated 2007 Long Term Incentive Plan for Employees (2007 Plan), the 2023 Long-Term Incentive Plan (2023 Plan), which replaces the 2007 Plan, and the 2019 ESPP, as discussed in Note 9. Stock Plans of the Consolidated Financial Statements. Also includes information from the 2020 Long Term Incentive Plan for Non-Employee Directors (2020 Directors' Plan). As of October 31, 2023, up to 1,376,240 shares of Common Stock may be issued pursuant to the 2023 Plan, up to 921,974 shares of Common Stock may be issued pursuant to the 2019 ESPP and up to 27,667 shares of Common Stock may be issued pursuant to the 2020 Directors' Plan.
Item 6. Reserved
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.
Note numbers refer to “Notes to Consolidated Financial Statements” in Item 8. Financial Statements and Supplementary Data.
Results of Operations
In this section, we discuss the results of our operations for fiscal 2023 compared with fiscal 2022. We discuss our cash flows and current financial condition under “Capital Resources and Liquidity.” For a discussion related to fiscal 2022 compared with fiscal 2021, please refer to Item 7 of Part II, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended October 31, 2022, which was filed with the United States Securities and Exchange Commission (SEC) on December 9, 2022, and is available on the SEC's website at www.sec.gov and our Investor Relations website at investor.coopercos.com.
Within the tables presented, percentages are calculated based on the underlying whole-dollar amounts and, therefore, may not recalculate exactly from the rounded numbers used for disclosure purposes.
Outlook
We are optimistic about the long-term prospects for the worldwide contact lens and general health care markets, and the resilience of and growth prospects for our businesses and products. However, we face significant risks and uncertainties in our global operating environment as further described in the “Risk Factors” section in Part I, Item 1A of this filing. These risks include uncertain global and regional business, political and economic conditions, including but not limited to those associated with man-made or natural disasters, pandemic conditions, inflation, foreign exchange rate fluctuations, regulatory developments, supply chain disruptions, and escalating global trade barriers. These risks and uncertainties have adversely affected our sales, cash flow and performance in the past and could further adversely affect our future sales, cash flow and performance.
CooperVision - We compete in the worldwide contact lens market with our spherical, toric, multifocal and toric multifocal contact lenses offered in materials like silicone hydrogel Aquaform technology. We believe that there will be lower contact lens wearer dropout rates as technology improves and enhances the wearing experience through a combination of improved designs and materials and the growth of preferred modalities such as single-use and monthly wearing options. CooperVision also competes in the myopia management and specialty eye care contact lens markets with myopia management contact lenses using its ActivControl technology and with products such as orthokeratology (ortho-k) and scleral lenses. CooperVision has FDA approval for its MiSight 1 day lens, which is the first and only FDA-approved product indicated to slow the progression of myopia in children with treatment initiated between the ages of 8-12. Further, CooperVision has Chinese NMPA approval for its MiSight 1 day lens for use in China. CooperVision is focused on greater worldwide market penetration using recently introduced products, and we continue to expand our presence in existing and emerging markets, including through acquisitions.
Our ability to compete successfully with a full range of silicone hydrogel products is an important factor to achieving our desired future levels of sales growth and profitability. CooperVision manufactures and markets a wide variety of silicone hydrogel contact lenses. Our single-use silicone hydrogel product franchises, clariti, MyDay and MyDay Energys remain a focus as we expect increasing demand for these products, as well as future single-use products, as the global contact lens market continues to shift to this modality. Outside of single-use, the Biofinity and Avaira Vitality product families comprise our focus in the FRP, or frequent replacement product, market which encompasses the monthly and two-week modalities. Included in this segment are unique products such as Biofinity Energys, which helps individuals with digital eye fatigue.
CooperSurgical - Our CooperSurgical business competes in the fertility and women's health care market through its diversified portfolio of products and services, including fertility products and services, medical devices, cryostorage (such as cord blood and cord tissue storage) and contraception. CooperSurgical has established its market presence and distribution system by developing products and acquiring companies, products and services that complement its business model.
Competitive factors in the segments in which CooperSurgical competes include technological and scientific advances, product quality and availability, price and customer service (including response time and effective communication of product information to physicians, consumers, fertility clinics and hospitals).
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Net Sales

CooperVision Net Sales
The contact lens market has two major product categories:
-
Spherical lenses including lenses that correct near- and farsightedness uncomplicated by more complex visual defects; and
-
Toric and multifocal lenses including lenses that, in addition to correcting near- and farsightedness, address more complex visual defects such as astigmatism and presbyopia by adding optical properties of cylinder and axis, which correct for irregularities in the shape of the cornea.
CooperVision Net Sales by Category


Single-use spheres – This includes Biomedics 1 day, clariti 1 day, MiSight, MyDay, and Proclear 1 day
Toric – This includes Avaira Vitality toric, Biofinity toric, Biomedics toric, clariti 1 day toric, MyDay toric and Proclear toric
Multifocal – This includes Biofinity multifocal, Biofinity toric multifocal, clariti 1 day multifocal, MyDay multifocal and Proclear 1 day multifocal
Non single-use sphere, other – This includes our frequent replacement product (FRP) lens portfolio (Avaira Vitality spheres, Biofinity spheres, Biofinity Energys spheres, Biomedics spheres, clariti spheres, Proclear spheres), specialty lenses (custom, ortho-k, and scleral lenses) and other.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
| ($ in millions) | 2023 | 2022 | 2023 vs. 2022 % Change | ||||||||||||||||||||||||||
| Toric | $ | 828.7 | $ | 737.4 | 12 | % | |||||||||||||||||||||||
| Multifocal | 305.7 | 264.4 | 16 | % | |||||||||||||||||||||||||
| Single-use spheres | 705.4 | 661.6 | 7 | % | |||||||||||||||||||||||||
| Non single-use sphere, other | 583.9 | 579.9 | 1 | % | |||||||||||||||||||||||||
| $ | 2,423.7 | $ | 2,243.3 | 8 | % |
In the fiscal year ended October 31, 2023, the growth experienced across all categories was partially offset by unfavorable foreign exchange rate fluctuations, which approximated $61.0 million.
-
Toric and multifocal lenses grew primarily through the success of MyDay and Biofinity.
-
Single-use sphere lenses grew primarily through MyDay, MiSight, and clariti lenses.
-
Non single-use sphere lenses grew primarily through specialty lenses.
-
"Other" products represented approximately 1% of net sales in fiscal 2023 and 2022.
CooperVision Net Sales by Geography
CooperVision competes in the worldwide soft contact lens market and services in three primary regions: the Americas, EMEA (Europe, Middle East and Africa) and Asia Pacific.
| ($ in millions) | 2023 | 2022 | 2023 vs. 2022 % Change | |||||||||||||||||
| Americas | $ | 991.3 | $ | 887.2 | 12 | % | ||||||||||||||
| EMEA | 891.6 | 843.7 | 6 | % | ||||||||||||||||
| Asia Pacific | 540.8 | 512.4 | 6 | % | ||||||||||||||||
| $ | 2,423.7 | $ | 2,243.3 | 8 | % |
CooperVision's growth in net sales across all regions was primarily attributable to market gains of silicone hydrogel contact lenses. Refer to CooperVision Net Sales by Category above for further discussion.
CooperSurgical Net Sales by Category
CooperSurgical supplies the fertility and women's health care market with a diversified portfolio of products and services. Our office and surgical offerings include products that facilitate surgical and non-surgical procedures that are commonly performed primarily by obstetricians and gynecologists in hospitals, surgical centers, fertility clinics and medical offices. Fertility offerings include highly specialized products and services that target the IVF process, including diagnostics testing with a goal to make fertility treatment safer, more efficient and convenient.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
The chart below shows the percentage of net sales of office and surgical and fertility.


Office/Surgical – This includes Endosee endometrial imaging products, Fetal Pillow cephalic elevation devices for use in Cesarean sections, illuminated speculum products, Lone Star retractor systems, loop electrosurgical excision procedure (LEEP) products, Mara water ablation systems, cryostorage (such as cord blood and cord tissue storage), Paragard contraceptive IUDs, point-of-care products and uterine positioning products.
Fertility – This includes fertility consumables and equipment, donor gamete services, and genomic services (including genetic testing).
| ($ in millions) | 2023 | 2022 | 2023 vs. 2022 % Change | ||||||||||||||||||||
| Office and surgical | $ | 689.5 | $ | 633.6 | 9 | % | |||||||||||||||||
| Fertility | 480.0 | 431.5 | 11 | % | |||||||||||||||||||
| $ | 1,169.5 | $ | 1,065.1 | 10 | % |
In the fiscal year ended October 31, 2023, the net sales increase in both categories was partially due to the addition of Generate Life Sciences (Generate) on December 17, 2021. Additionally, office and surgical net sales increased due to an increase in sales from products such as Uterine Manipulators, Fetal Pillow and Surgical Retractors, and fertility net sales increased due to an increase in revenue from consumable products and genomic services. The increase was partially offset by unfavorable foreign exchange rate fluctuations, which approximated $15.1 million.
Gross Margin
Consolidated Gross Margin was relatively flat at 66% in fiscal 2023 compared to 65% in fiscal 2022.
Selling, General and Administrative (SGA) Expenses
| ($ in millions) | 2023 | % Net Sales | 2022 | % Net Sales | 2023 vs. 2022 % Change | ||||||||||||||||||||||||
| CooperVision | $ | 871.1 | 36 | % | $ | 826.7 | 37 | % | 5 | % | |||||||||||||||||||
| CooperSurgical | 559.4 | 48 | % | 461.7 | 43 | % | 21 | % | |||||||||||||||||||||
| Corporate | 70.7 | — | 53.8 | — | 31 | % | |||||||||||||||||||||||
| $ | 1,501.2 | 42 | % | $ | 1,342.2 | 41 | % | 12 | % |
CooperVision's SGA expenses increased in fiscal 2023 compared to fiscal 2022 primarily due to an increase in selling and marketing activities, distribution costs, and an intangible assets impairment charge associated with the discontinuation of
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
certain products, partially offset by $31.8 million release of contingent consideration liability associated with SightGlass Vision's regulatory approval milestone.
CooperSurgical's SGA expenses increased in fiscal 2023 compared to fiscal 2022 primarily due to an increase in selling and marketing activities and the payment of a $45.0 million termination fee under an asset purchase agreement related to Cook Medical’s reproductive health business. See Note 3. Acquisitions and Joint Venture for further information on the termination fee.
Corporate SGA expenses increased in fiscal 2023 compared to fiscal 2022 primarily due to share-based compensation related expenses.
Research and Development (R&D) Expenses
| ($ in millions) | 2023 | % Net Sales | 2022 | % Net Sales | 2023 vs. 2022 % Change | ||||||||||||||||||||||||
| CooperVision | $ | 73.4 | 3 | % | $ | 62.4 | 3 | % | 18 | % | |||||||||||||||||||
| CooperSurgical | 64.0 | 5 | % | 47.9 | 4 | % | 34 | % | |||||||||||||||||||||
| $ | 137.4 | 4 | % | $ | 110.3 | 3 | % | 25 | % |
CooperVision's R&D expenses increased in fiscal 2023 compared to fiscal 2022 primarily due to European Medical Device Regulation costs and myopia management programs, and timing of R&D projects. CooperVision's R&D activities are primarily focused on the development of contact lenses, manufacturing technology and process enhancements.
CooperSurgical's R&D expenses increased in fiscal 2023 compared to fiscal 2022 mainly due to European Medical Device Regulation costs. CooperSurgical's R&D activities are focused on developing and refining diagnostic and therapeutic products including medical interventions, surgical devices and fertility solutions.
Amortization Expense
| ($ in millions) | 2023 | % Net Sales | 2022 | % Net Sales | 2023 vs. 2022 % Change | ||||||||||||||||||||||||
| CooperVision | $ | 32.9 | 1 | % | $ | 32.3 | 1 | % | 2 | % | |||||||||||||||||||
| CooperSurgical | 153.3 | 13 | % | 147.2 | 14 | % | 4 | % | |||||||||||||||||||||
| $ | 186.2 | 5 | % | $ | 179.5 | 5 | % | 4 | % |
CooperVision's amortization expense for fiscal 2023 compared to fiscal 2022 remained relatively flat year over year.
CooperSurgical's amortization expense increased in fiscal 2023 compared to fiscal 2022, primarily due to the amortization of intangible assets recently acquired through acquisitions.
Operating Income
| ($ in millions) | 2023 | % Net Sales | 2022 | % Net Sales | 2023 vs. 2022 % Change | ||||||||||||||||||||||||
| CooperVision | $ | 587.7 | 24 | % | $ | 494.3 | 22 | % | 19 | % | |||||||||||||||||||
| CooperSurgical | 16.1 | 1 | % | 67.1 | 6 | % | (76) | % | |||||||||||||||||||||
| Corporate | (70.7) | — | (53.8) | — | (31) | % | |||||||||||||||||||||||
| $ | 533.1 | 15 | % | $ | 507.6 | 15 | % | 5 | % |
CooperVision's operating income increased in fiscal 2023 compared to fiscal 2022, primarily due to an increase in net sales partially offset by net changes in operating expenses.
CooperSurgical's operating income decreased in fiscal 2023 compared to fiscal 2022, primarily due to an increase in SGA and R&D expenses, partially offset by an increase in net sales.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Corporate operating loss increased in fiscal 2023 compared to fiscal 2022, primarily due to higher share-based compensation expenses.
Interest Expense
| ($ in millions) | 2023 | % Net Sales | 2022 | % Net Sales | 2023 vs. 2022 % Change | ||||||||||||||||||||||||
| Interest expense | $ | 105.3 | 3 | % | $ | 57.3 | 2 | % | 84 | % |
Interest expense increased during fiscal 2023 compared to the prior year, primarily due to higher interest rates.
Other Expense (Income), Net
| ($ in millions) | 2023 | 2022 | |||||||||
| Investment gain | $ | — | $ | (47.7) | |||||||
| Foreign exchange loss | 7.0 | 22.0 | |||||||||
| Other expense (income), net | 7.9 | 0.7 | |||||||||
| $ | 14.9 | $ | (25.0) |
Investment gain in fiscal 2022 primarily consists of a gain on remeasurement of the fair value of retained equity investment in SGV as a result of deconsolidation.
Foreign exchange loss is primarily associated with the weakening of the U.S. dollar against foreign currencies and the effect on intercompany receivables.
Other expenses (income), net increased in fiscal 2023, primarily due to a loss on minority investments, partially offset by defined benefit plan related income.
Provision for Income Taxes
The effective tax rates for fiscal 2023 and 2022 were 28.7% and 18.8%, respectively. The increase was primarily due to changes in the geographic composition of pre-tax earnings, an increase in the UK statutory tax rate from 19% to 25%, capitalization of research and experimental expenditures for fiscal 2023 as required by the 2017 Tax Cuts and Jobs Act, and changes in unrecognized tax benefits.
The effective tax rate for fiscal 2023 was higher than the US federal statutory rate primarily due to foreign earnings subject to US tax. The effective tax rate for fiscal 2022 was lower than the US federal statutory rate primarily due to foreign earnings in jurisdictions with lower tax rates and changes in unrecognized tax benefits, partially offset by foreign earnings subject to US tax.
See Note 6. Income Taxes for further information.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
CAPITAL RESOURCES AND LIQUIDITY
Working capital at October 31, 2023 and October 31, 2022, was $735.9 million and $253.4 million, respectively. The increase in working capital was primarily due to repayment of the 364-day term loan during fiscal 2023 and an increase in inventories. See Note 5. Financing Arrangements for further information.
Cash Flow
| ($ in millions) | 2023 | 2022 | 2021 | ||||||||||||||
| Operating activities | $ | 607.5 | $ | 692.4 | $ | 738.6 | |||||||||||
| Investing activities | (449.0) | (1,831.2) | (450.3) | ||||||||||||||
| Financing activities | (173.9) | 1,193.7 | (311.4) | ||||||||||||||
| Effect of exchange rate changes on cash, cash equivalents, restricted cash and restricted cash equivalents | (2.3) | (12.9) | 2.9 | ||||||||||||||
| (Decrease) increase in cash, cash equivalents, restricted cash and restricted cash equivalents | $ | (17.7) | $ | 42.0 | $ | (20.2) |
Operating Cash Flow
Cash provided by operating activities in fiscal 2023 decreased compared to fiscal 2022, primarily due to the payment of a $45 million termination fee under an asset purchase agreement and net changes in operating capital, partially offset by net changes in other non-cash items.
The $45.0 million termination fee under an asset purchase agreement related to Cook Medical’s reproductive health business was accrued for during the second quarter of fiscal 2023 and paid on August 9, 2023. See Note 3. Acquisitions and Joint Venture for further information on the termination fee.
Investing Cash Flow
Cash used in investing activities in fiscal 2023 was lower than cash used in investing activities in fiscal 2022, primarily attributable to $1.6 billion cash paid, net of cash acquired, for the Generate acquisition in fiscal 2022. The decrease in cash used for acquisitions was partially offset by an increase in purchases of property, plant and equipment.
Financing Cash Flow
Cash used in financing activities in fiscal 2023 was primarily due to repayments of $338.0 million on the 2021 364-day term loan, partially offset by $172.6 million of funds drawn on the 2020 Revolving Credit.
Cash provided by financing activities in fiscal 2022 was primarily due to funds received from the 2021 term loan facility ($1.5 billion) and the 2021 364-day term loan facility ($840.0 million), partially offset by $561.5 million repayments of the 2020 Revolving Credit, $502.0 million repayments of the 2021 364-day term loan facility, and $78.5 million repurchases of common stock.
The following is a summary of the maximum commitments and the net amounts available to us under different credit facilities as of October 31, 2023:
| (In millions) | Facility Limit | Outstanding Borrowings | Outstanding Letters of Credit | Total Amount Available | Maturity Date | |||||||||||||||||||||||||||
| Revolving Credit: | ||||||||||||||||||||||||||||||||
| 2020 Revolving Credit | $ | 1,290.0 | $ | 172.6 | $ | 2.1 | $ | 1,115.3 | April 1, 2025 | |||||||||||||||||||||||
| Term Loan: | ||||||||||||||||||||||||||||||||
| 2020 Term Loan | 850.0 | 850.0 | n/a | — | April 1, 2025 | |||||||||||||||||||||||||||
| 2021 Term Loan | 1,500.0 | 1,500.0 | n/a | — | December 17, 2026 | |||||||||||||||||||||||||||
| Total | $ | 3,640.0 | $ | 2,522.6 | $ | 2.1 | $ | 1,115.3 |
As of October 31, 2023, the Company was in compliance with all debt covenants. See Note 5. Financing Arrangements for further information.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Considering recent market conditions, we have re-evaluated our operating cash flows and cash requirements and continue to believe that current cash, cash equivalents, future cash flow from operating activities and cash available under our 2020 Credit Agreement will be sufficient to meet our anticipated cash needs, including working capital needs, capital expenditures and contractual obligations for at least 12 months from the issuance date of the Consolidated Financial Statements included in this annual report. To the extent additional funds are necessary to meet our liquidity needs such as that for acquisitions, share repurchases, cash dividends or other activities as we execute our business strategy, we anticipate that additional funds could be obtained through the incurrence of additional indebtedness, additional equity financings or a combination of these potential sources of funds; however, such financing may not be available on favorable terms, or at all.
Share Repurchases
In December 2011, the Company's Board of Directors authorized the 2012 Share Repurchase Program ("2012 Program") and through subsequent amendments, the most recent in March 2017, the total repurchase authorization was increased from $500.0 million to $1.0 billion of the Company's common stock. The program has no expiration date and may be discontinued at any time. Purchases under the 2012 Program are subject to a review of the circumstances in place at the time and may be made from time to time as permitted by securities laws and other legal requirements.
In fiscal 2023, there were no share repurchases under the 2012 Program. At October 31, 2023, $256.4 million remained authorized for repurchase under the program. See Note 8. Stockholders’ Equity for additional information.
Dividends
In fiscal 2023 and 2022, the Company declared regular dividends of 6 cents per share (a semiannual dividend of 3 cents per share) and paid a total of $3.0 million in each fiscal year. In December 2023, our Board of Directors decided to end the declaration of the semiannual dividend.
Contractual Obligations
As of October 31, 2023, we had the following contractual obligations:
| Payments Due by Fiscal Year (In millions) | Total | 2024 | 2025 & 2026 | 2027 & 2028 | 2029 & Beyond | ||||||||||||||||||||||||
| Interest payments | $ | 249.0 | $ | 113.3 | $ | 135.7 | $ | — | $ | — | |||||||||||||||||||
| Transition tax on unremitted foreign earnings and profits (1) | 88.6 | 22.1 | 66.5 | — | — | ||||||||||||||||||||||||
| Purchase obligations (2) | 408.5 | 201.7 | 139.7 | 62.0 | 5.1 | ||||||||||||||||||||||||
| Total contractual obligations | $ | 746.1 | $ | 337.1 | $ | 341.9 | $ | 62.0 | $ | 5.1 | |||||||||||||||||||
(1) As of October 31, 2023, we had $88.6 million of income tax liabilities related to the one-time transition tax that resulted from the enactment of the 2017 US Tax Act, which is payable in annual installments through fiscal 2026. The installment for fiscal 2023 is classified in "Other current liabilities" in our Consolidated Balance Sheet.
We are unable to reliably estimate the timing of future payments related to uncertain tax positions and have excluded $24.0 million of long-term income taxes payable from the table above. See Note 6. Income Taxes for additional information.
(2) Purchase obligations consist of agreements to purchase goods and services that are enforceable and legally binding and includes obligations for inventory, capital expenditures and other operating expense commitments.
The table above excludes future payments for operating leases, long-term debt, and our defined benefit plan. The minimum future payments for operating leases are disclosed in Note 2. Operating Leases and future maturities of long-term debt are disclosed in Note 5. Financing Arrangements. The expected future benefit payments for our Retirement Income Plan through 2033 are disclosed in Note 10. Employee Benefits.
Transition from LIBOR
The UK’s Financial Conduct Authority (FCA), which regulates the London Interbank Offered Rate (LIBOR), announced in July 2017 that it will no longer persuade or require banks to submit rates for LIBOR after 2021. In March 2021, the FCA confirmed its intention to stop requiring banks to submit rates required to calculate LIBOR after 2021. However, for U.S. dollar-denominated (USD) LIBOR, only one-week and two-month USD LIBOR will cease to be published after 2021, and all remaining USD LIBOR tenors will continue being published until June 2023. Further, in March 2020, the Financial Accounting Standards Board (FASB) issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
of Reference Rate Reform on Financial Reporting. This guidance provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. Effective February 1, 2023, the Company transitioned its credit agreements from LIBOR to the Secured Overnight Financing Rate ("SOFR").
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Estimates
Management estimates and judgments are an integral part of financial statements prepared in accordance with GAAP. We consider an accounting estimate critical if changes in the estimate may have a material impact on our financial condition or results of operations. We believe that the accounting estimates employed are appropriate and resulting balances are reasonable, however, actual results could differ from the original estimates, requiring adjustment to these balances in future period. The critical accounting policies described in this section address the more significant estimates required of management when preparing the Consolidated Financial Statements in accordance with GAAP.
- Revenue recognition - We recognize revenue from product sales when obligations under the terms of a contract with the customer are satisfied; generally, this occurs with the transfer of control of the goods to customers and/or when services are rendered. Our payment terms are typically between 30 to 120 days. Provisions for certain rebates, sales incentives, volume discounts, contractual pricing allowances and product returns are accounted for as variable consideration and recorded as a reduction in sales.
Product discounts, including certain rebates, sales incentives, and volume discounts are granted based on terms of the arrangement with direct distribution customers and at times the indirect end consumer. We evaluate contractual terms, historical experience, and perform internal analysis to estimate total product discounts at the time revenue is recognized. CooperSurgical rebates are predominately related to the Medicaid rebate provision that is estimated based upon contractual terms, historical experience, and trend analysis.
Sales returns are estimated and recorded based on historical sales return data. Promotional programs, such as cooperative advertising arrangements, are recorded in the same period as related sales. Reasonably likely changes to assumptions used to calculate the accruals for rebates, sales incentives, volume discounts, contractual pricing allowances and product returns are not anticipated to have a material effect on the financial statements. We currently disclose the impact of changes to assumptions in the quarterly or annual filing in which there is a material financial statement impact.
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Business combinations - We routinely consummate business combinations. Results of operations for acquired companies are included in our consolidated results of operations from the date of acquisition. We recognize separately from goodwill, the identifiable assets acquired, including acquired in-process research and development, the liabilities assumed, and any noncontrolling interest in the acquiree at the acquisition date fair values as defined by accounting standards related to fair value measurements. Key assumptions routinely utilized the allocation of purchase price to intangible assets include discount rates, and projected financial information such as revenue projections for companies acquired. As of the acquisition date, goodwill is measured as the excess of consideration given, over the net of the acquisition date fair values of the identifiable assets acquired and the liabilities assumed. Direct acquisition costs are expensed as incurred.
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Income taxes - Income taxes are estimated based on enacted income tax laws and the results of operations in each jurisdiction. Deferred tax assets and liabilities are estimated based on temporary differences between the financial reporting basis and income tax basis of assets and liabilities. Deferred tax assets are reduced by a valuation allowance to the extent it is more likely than not they are not expected to be realized. Long-term tax payable is estimated income tax to be paid for unrecognized tax benefits. A tax benefit is recognized if it is more likely than not a tax position will be sustained based on its technical merits in a tax authority examination, based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the tax authority.
Accounting Pronouncements
Information regarding new accounting pronouncements is included in Note 1. Organization and Significant Accounting Policies.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Item 7A. Quantitative and Qualitative Disclosure About Market Risk.
We are exposed to market risks that relate principally to changes in interest rates and foreign currency fluctuations. We do not enter into derivative financial instrument transactions for speculative purposes.
Foreign Currency Exchange Risk
We operate multiple foreign subsidiaries that manufacture and market our products worldwide. As a result, our earnings, cash flow and financial position are exposed to foreign currency risk from foreign currency denominated receivables and payables, sales transactions, capital expenditures and net investment in certain foreign operations. Most of our operations outside the United States have their local currency as their functional currency. We have exposure to multiple foreign currencies, including, among others, the British pound, Euro and Japanese yen. We have taken steps to minimize our balance sheet exposure by entering into foreign currency forward contracts to minimize the short-term impact of foreign currency exchange rate fluctuations on certain trade and intercompany receivables and payables.
At October 31, 2023, a uniform hypothetical 10% increase or decrease in the foreign currency exchange rates in comparison to the value of the U.S. dollar would have resulted in a corresponding increase or decrease of approximately $95.6 million in operating income for the fiscal year ended October 31, 2023. Refer to Item 1A. Risk Factors - "Our substantial and expanding international operations are subject to uncertainties which could affect our business." and Note 1. Organization and Significant Accounting Policies for further information.
Interest Rate Risk
We are exposed to risks associated with changes in interest rates, as the interest rates on our revolving lines of credit and term loans may vary with the federal funds rate and SOFR (and, previously, LIBOR). As of October 31, 2023, we had outstanding debt for an aggregate carrying amount of $2.6 billion. We have entered, and in the future may enter, into interest rate swaps to manage interest rate risk. Effective February 1, 2023, the base interest rate on our credit agreements was converted from LIBOR to SOFR.
Our ultimate realized gain or loss with respect to interest rate fluctuations will depend on interest rates, the exposures that arise during the period and our hedging strategies at that time. As an example, if interest rates were to increase or decrease by 1% or 100 basis points, the quarterly interest expense would not have a material impact, based on average debt outstanding, after consideration of our interest rate swap contracts, during the fourth quarter of fiscal 2023. Refer to Item 1A. Risk Factors - "We are vulnerable to interest rate risk with respect to our debt." and Note 5. Financing Arrangements for further information.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Item 8. Financial Statements and Supplementary Data.
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors
The Cooper Companies, Inc.:
Opinions on the Consolidated Financial Statements and Internal Control Over Financial Reporting
We have audited the accompanying consolidated balance sheets of The Cooper Companies, Inc. and subsidiaries (the Company) as of October 31, 2023 and 2022, the related consolidated statements of income, comprehensive income, stockholders’ equity, and cash flows for each of the years in the three-year period ended October 31, 2023, and the related notes and financial statement Schedule II (collectively, the consolidated financial statements). We also have audited the Company’s internal control over financial reporting as of October 31, 2023, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of October 31, 2023 and 2022, and the results of its operations and its cash flows for each of the years in the three-year period ended October 31, 2023, in conformity with U.S. generally accepted accounting principles. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of October 31, 2023, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
Basis for Opinions
The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s consolidated financial statements and an opinion on the Company’s internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Evaluation of the sufficiency of audit evidence over inventories and net sales
As discussed in Notes 1 and 12 to the consolidated financial statements and disclosed in the consolidated balance sheet and consolidated statement of income, the Company recorded $735.6 million in inventories and $3,593.2 million in net sales as of and for the year ended October 31, 2023, respectively. Inventories are primarily comprised of raw materials, work-in-process, and finished goods that are physically located at certain of the Company's locations. Net sales are recognized primarily from the sale of products from each of the Company's locations.
We identified the evaluation of the sufficiency of audit evidence over inventories and net sales as a critical audit matter. Evaluating the sufficiency of the audit evidence obtained required subjective auditor judgment because of the decentralized structure and geographic dispersion of the Company's manufacturing and distribution locations. This included determining the locations for which procedures were performed.
The following are the primary procedures we performed to address this critical audit matter. We applied auditor judgment to determine the nature and extent of procedures to be performed over inventories and net sales, including the determination of the Company’s locations for which those procedures were performed. For certain locations where procedures were performed, we evaluated the design and tested the operating effectiveness of certain internal controls over the Company's inventories and net sales processes, including controls over the amounts recorded in inventories and the amounts recorded in net sales.
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
The Company has established and currently maintains disclosure controls and procedures designed to ensure that information required to be disclosed in its reports filed under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified by the Securities and Exchange Commission's rules and forms and that such information is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, management recognizes that controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
In conjunction with the close of each fiscal quarter, the Company conducts a review and evaluation, under the supervision and with the participation of the Company's management, including the Chief Executive Officer (our Principal Executive Officer) and Chief Financial Officer (our Principal Financial Officer), of the effectiveness of the design and operation of the Company's disclosure controls and procedures. The Company's Chief Executive Officer and Chief Financial Officer based upon their evaluation as of October 31, 2023, the end of the fiscal period covered in this report, concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level.
Management's Annual Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements, errors or fraud.
Management assessed the effectiveness of the Company's internal control over financial reporting as of October 31, 2023, based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control - Integrated Framework (2013). Based on this assessment, management, under the supervision and with the participation of the Company's Chief Executive Officer and Chief Financial Officer, concluded that the Company's internal control over financial reporting was effective as of October 31, 2023.
The Company's independent registered public accounting firm, KPMG LLP, has audited the effectiveness of the Company's internal control over financial reporting as of October 31, 2023, as stated in their report in Part II, Item 8 of this Annual Report on Form 10-K.
Changes in Internal Control Over Financial Reporting
There have been no changes in the Company's internal control over financial reporting during the Company's fiscal quarter ended October 31, 2023, that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting.
Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not Applicable.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The information required by this item is incorporated by reference to the Company’s Proxy Statement for the 2024 Annual Meeting of Stockholders (the 2024 Proxy Statement).
Item 11. Executive Compensation.
The information required by this item is incorporated by reference to the 2024 Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
See Item 5. Market for Registrant's Common Equity and Related Stockholder Matters - Equity Compensation Plan Information. Additional information required by this item is incorporated by reference to the 2024 Proxy Statement.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item is incorporated by reference to the 2024 Proxy Statement.
Item 14. Principal Accounting Fees and Services.
The information required by this item is incorporated by reference to the 2024 Proxy Statement.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
PART IV
Item 15. Exhibits and Financial Statement Schedules.
(a) 1. Financial Statements
The following financial statements are filed as a part of this report:
Report of KPMG LLP, Independent Registered Public Accounting Firm
Consolidated Financial Statements:
Statements of Income for the years ended October 31, 2023, 2022 and 2021
Statements of Comprehensive Income for the years ended October 31, 2023, 2022 and 2021
Balance Sheets as of October 31, 2023 and 2022
Statements of Stockholders' Equity for the years ended October 31, 2023, 2022 and 2021
Statements of Cash Flows for the years ended October 31, 2023, 2022 and 2021
Notes to Consolidated Financial Statements
- Financial Statement Schedules of the Company.
Schedule Number Description
Schedule II Valuation and Qualifying Accounts
(b) Exhibits.
The exhibits listed on the accompanying Exhibit Index are filed as part of this report.
All other schedules which are included in the applicable accounting regulations of the Securities and Exchange Commission are not required here because they are not applicable.
Schedule II
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
VALUATION AND QUALIFYING ACCOUNTS
Three Years Ended October 31, 2023
| (In millions) | Balance Beginning of Year | Additions | Reductions/ Charges | Balance at End of Year | |||||||||||||||||||
| Deferred income tax valuation allowance: | |||||||||||||||||||||||
| Year Ended October 31, 2023 | 60.1 | 2.6 | (42.0) | 20.7 | |||||||||||||||||||
| Year Ended October 31, 2022 | 51.8 | 13.3 | (5.0) | 60.1 | |||||||||||||||||||
| Year Ended October 31, 2021 | 45.3 | 8.8 | (2.3) | 51.8 |
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
EXHIBIT INDEX
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
| Incorporated by Reference | ||||||||||||||
| Exhibit Number | Description of Document | Form | Exhibit | Filing Date/ Period End Date | ||||||||||
| 10.27# | Form of Stock Option Agreement for the 2023 Long-Term Incentive Plan | 10-Q | 10.2 | 4/30/2023 | ||||||||||
| 10.28# | Form of Restricted Stock Unit Agreement for the 2023 Long-Term Incentive Plan | 10-Q | 10.3 | 4/30/2023 | ||||||||||
| 10.29# | Form of Performance Stock Unit Agreement for the 2023 Long-Term Incentive Plan | 10-Q | 10.4 | 4/30/2023 | ||||||||||
| 10.31# | The Cooper Companies, Inc. 2017 Executive Incentive Plan | 14A | A | 1/27/2017 | ||||||||||
| 10.32# | The Cooper Companies, Inc. Compensation Recovery Policy | |||||||||||||
| 19 | Stock Trading Policy | |||||||||||||
| 21 | Subsidiaries | |||||||||||||
| 23 | Consent of Independent Registered Public Accounting Firm | |||||||||||||
| 31.1 | Certification of the Chief Executive Officer, pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934 | |||||||||||||
| 31.2 | Certification of the Chief Financial Officer, pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934 | |||||||||||||
| 32.1* | Certification of the Chief Executive Officer, pursuant to 18 U.S.C. Section 1350 | |||||||||||||
| 32.2* | Certification of the Chief Financial Officer, pursuant to 18 U.S.C. Section 1350 | |||||||||||||
| 101 | The following materials from the Company's Annual Report on Form 10-K for the year ended October 31, 2023, formatted in Inline XBRL (Extensible Business Reporting Language):(i) Consolidated Statements of Income for the years ended October 31, 2023, 2022 and 2021 (ii) Consolidated Statements of Comprehensive Income for the years ended October 31, 2023, 2022 and 2021 (iii) Consolidated Balance Sheets at October 31, 2023 and 2022, (iv) Consolidated Statements of Stockholders' Equity for the years ended October 31, 2023, 2022 and 2021 (v) Consolidated Statements of Cash Flows for the years ended October 31, 2023, 2022 and 2021, (vi) related notes to consolidated financial statements and (vii) Schedule II Valuation and Qualifying Accounts | |||||||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
(a) The agreement received confidential treatment from the Securities and Exchange Commission with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Commission.
Indicates management contract or compensatory plan.
- The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report on Form 10-K are not deemed filed with the SEC and are not to be incorporated by reference into any filing of The Cooper Companies, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-K, irrespective of any general incorporation language contained in such filing.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Item 16. Form 10-K Summary.
None.
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on December 8, 2023.
THE COOPER COMPANIES, INC.
By: /s/ Albert G. White, III
Albert G. White, III
President & Chief Executive Officer
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities indicated on the dates set forth opposite their respective names.
| Signature | Capacity | Date | ||||||||||||
| /s/ ALBERT G. WHITE, III | President, Chief Executive Officer and Director (Principal Executive Officer) | December 8, 2023 | ||||||||||||
| (Albert G. White, III) | ||||||||||||||
| /s/ ROBERT S. WEISS | Chairman of the Board | December 8, 2023 | ||||||||||||
| (Robert S. Weiss) | ||||||||||||||
| /s/ WILLIAM A. KOZY | Vice Chairman of the Board and Lead Director | December 8, 2023 | ||||||||||||
| (William A. Kozy) | ||||||||||||||
| /s/ BRIAN G. ANDREWS | Executive Vice President, Chief Financial Officer and Treasurer | December 8, 2023 | ||||||||||||
| (Brian G. Andrews) | (Principal Financial Officer) | |||||||||||||
| /s/ AGOSTINO RICUPATI | Senior Vice President and Chief Accounting Officer | December 8, 2023 | ||||||||||||
| (Agostino Ricupati) | (Principal Accounting Officer) | |||||||||||||
| /s/ COLLEEN E. JAY | Director | December 8, 2023 | ||||||||||||
| (Colleen E. Jay) | ||||||||||||||
| /s/ CYNTHIA L. LUCCHESE | Director | December 8, 2023 | ||||||||||||
| (Cynthia L. Lucchese) | ||||||||||||||
| /s/ GARY S. PETERSMEYER | Director | December 8, 2023 | ||||||||||||
| (Gary S. Petersmeyer) | ||||||||||||||
| Director | December 8, 2023 | |||||||||||||
| (Lawrence Kurzius) | ||||||||||||||
| /s/ MARIA RIVAS M.D. | Director | December 8, 2023 | ||||||||||||
| (Maria Rivas M.D.) | ||||||||||||||
| /s/ TERESA S. MADDEN | Director | December 8, 2023 | ||||||||||||
| (Teresa S. Madden) |
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
CORPORATE INFORMATION
| BOARD OF DIRECTORS Robert S. Weiss Chairman of the Board William A. Kozy Vice Chairman and Lead Director; Chief Executive Officer (interim), LivaNova PLC Colleen E. Jay Director Cynthia L. Lucchese Director Gary S. Petersmeyer Director Lawrence Kurzius Director Teresa S. Madden Director Maria Rivas M.D. Global Chief Medical Affairs Officer and Head of Evidence Generation, Pfizer, Inc. Albert G. White, III President & Chief Executive Officer COMMITTEES OF THE BOARD Audit Committee Teresa S. Madden (Chairman) Cynthia L. Lucchese Gary S. Petersmeyer Lawrence Kurzius Maria Rivas M.D. Corporate Governance and Nominating Committee William A. Kozy (Chairman) Colleen E. Jay Cynthia L. Lucchese Maria Rivas M.D. Organization and Compensation Committee Colleen E. Jay (Chairman) Gary S. Petersmeyer Lawrence Kurzius Teresa S. Madden William A. Kozy | EXECUTIVE OFFICERS Albert G. White, III President and Chief Executive Officer Daniel G. McBride Executive Vice President and Chief Operating Officer Brian G. Andrews Executive Vice President, Chief Financial Officer and Treasurer Agostino Ricupati Senior Vice President and Chief Accounting Officer Nicholas S. Khadder Vice President, General Counsel and Corporate Secretary Holly R. Sheffield President of CooperSurgical, Inc. Gerard H. Warner III President of CooperVision, Inc. PRINCIPAL SUBSIDIARIES CooperVision, Inc. 6101 Bollinger Canyon Road Suite 500 San Ramon, CA 94583 925-460-3600 www.coopervision.com CooperSurgical, Inc. 75 Corporate Drive Trumbull, CT 06611 203-601-5200 www.coopersurgical.com CORPORATE OFFICES The Cooper Companies, Inc. 6101 Bollinger Canyon Road Suite 500 San Ramon, CA 94583 925-460-3600 www.coopercos.com | INVESTOR INFORMATION Recent news releases, the annual report on Securities and Exchange Commission Form 10-K, information about the Company's corporate governance program, recent investor presentations, replays of quarterly conference calls and historical stock quotes are available on our Web site at www.coopercos.com. INVESTOR RELATIONS CONTACT Kim Duncan Vice President, Investor Relations and Risk Management 6101 Bollinger Canyon Road Suite 500 San Ramon, CA 94583 Voice: 925-460-3663 E-mail: ir@cooperco.com ANNUAL MEETING The Cooper Companies will hold its Annual Stockholders' Meeting in March 2024. TRANSFER AGENT Equiniti Trust LLC 48 Wall Street, Floor 23 New York, NY 10005 800-937-5449 TRADEMARKS CooperVision, CooperSurgical, and other trade names, trademarks or service marks of CooperCompanies and its subsidiaries appearing in this report are the property of CooperCompanies and its subsidiaries. Trade names, trademarks and service marks of the other companies appearing in this report are the property of their respective holders. INDEPENDENT AUDITORS KPMG LLP STOCK EXCHANGE LISTING Nasdaq Global Select Market Ticker Symbol “COO” |