COO · 10-K filed 5 Dec 2025 · year to 31 Oct 2025

Cooper Companies

37 named things its latest annual report says its results depend on, each in the company's own words. 23 of them are also named by other companies we've read.

Read the filing on SEC.gov ↗

Customers

Key account customers (optical chains, retailers, buying groups)

earns fromnamed as a risk

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.Risk factors (Item 1A)

Other companies

Paragard

earns fromnamed as a risk

The manufacture of drug-device combination products, such as Paragard, is complex and requires significant expertise and capital investment.Risk factors (Item 1A)

Competitors

Johnson & Johnson Vision Care, Inc.

competes withnamed as a risk

Our largest competitors in the contact lens business, Johnson & Johnson Vision Care, Inc., Alcon Inc. and Bausch Health Companies Inc. may have substantially greater financial resources, larger research and development budgets, larger sales forces, greater market penetration and/or larger manufacturing volumes than CooperVision.Risk factors (Item 1A)

Alcon Inc.

competes withnamed as a risk

Bausch + Lomb

competes withnamed as a risk

Miudella

competes withnamed as a risk

A non-hormonal IUD, Miudella, which has been FDA approved and not currently in the market, will compete with Paragard in the future.Business (Item 1)

Bayer

competes with

With Paragard, we compete with manufacturers of hormonal IUDs including Bayer and AbbVie, Long Acting Reversible Contraceptives including Organon, and other forms of birth control.Business (Item 1)

Also named by CTVA, EXEL, GEHC, REGN

Vitrolife Group

competes with

In the fertility market, CooperSurgical competes against Vitrolife Group, Nexpring, and Fairfax Cryobank and Fairfax EggBank.Business (Item 1)

ViaCord (Revvity)

competes with

In the stem cell storage field, we compete primarily with ViaCord, a division of Revvity, in the United States, as well as other smaller companies with limited product offerings globally.Business (Item 1)

Places

Outside the United States (international sales)

earns from · Approximately half of our net salesnamed as a risk

Approximately half of our net sales for the fiscal years ended October 31, 2025, and 2024, were derived from the sale of products outside the United States.Risk factors (Item 1A)

Also named by APD, ARW, BALL, CCK, GGG, GIS, HPE, LITE and 10 more

China

earns fromnamed as a risk

difficulty gaining market share in countries such as China because of regulatory restrictions and customer preferences;Risk factors (Item 1A)

Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more

Puerto Rico

operates innamed as a risk

CooperVision manufactures molded contact lenses, which represent the majority of our contact lens revenues, primarily at our facilities in Costa Rica, Hungary, Puerto Rico, the United Kingdom and the United States, with other smaller facilities also existing in multiple locations around the world.Risk factors (Item 1A)

Also named by AMGN, BMY, BPOP, CCI, GMED, HPE, LLY, PWR and 2 more

Netherlands

operates innamed as a risk

CooperSurgical primarily distributes products out of its facilities in the United States and the Netherlands and operates fertility and stem cell storage facilities in the United States, Canada and Australia.Risk factors (Item 1A)

Also named by ANET, BKNG, CACI, CROX, GILD, PCAR

Belgium

operates innamed as a risk

CooperVision distributes products out of Belgium, Hungary, the United Kingdom and the United States and various smaller international distribution sites.Risk factors (Item 1A)

Also named by BNY, EL, HROW, LBTYA

Costa Rica

operates innamed as a risk

Also named by EW, GMED

Hungary

operates innamed as a risk

CooperVision distributes products out of Belgium, Hungary, the United Kingdom and the United States and various smaller international distribution sites.Risk factors (Item 1A)

Also named by CDNS

New Jersey

operates in

We have current certification under CLIA to perform testing at our New Jersey facility.Business (Item 1)

Also named by AWK, AXP, FE, MUSA, NLY, PEG

Commodities and inputs

SOFR

exposed to its price · $2.5 billionnamed as a 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.Market risk (Item 7A)

Also named by AAP, AIOT, APG, APH, ARES, AXON, BGC, BR and 82 more

British pound

exposed to its price · approximately $114.4 million in operating incomenamed as a risk

Our most significant currency exposures are the British pound, Euro and Japanese yen.Risk factors (Item 1A)

Also named by ABBV, ADBE, AJG, AME, AMP, APA, BF/B, BRO and 39 more

Euro

exposed to its pricenamed as a risk

Our most significant currency exposures are the British pound, Euro and Japanese yen.Risk factors (Item 1A)

Also named by ABBV, ABNB, ABT, ADBE, ADI, AME, AMG, AMGN and 186 more

Japanese yen

exposed to its pricenamed as a risk

Our most significant currency exposures are the British pound, Euro and Japanese yen.Risk factors (Item 1A)

Also named by ABBV, ABT, ACN, ADBE, ALK, AMAT, AMKR, BMY and 24 more

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk

Our products are subject to extensive regulation by the FDA in the United States and a variety of regulatory agencies in other countries.Business (Item 1)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

Centers for Medicare & Medicaid Services (CMS)

subject tonamed as a risk

The CMS in particular has the authority to impose a wide range of sanctions, including revocation of CLIA certification along with a bar on the ownership or operation of a CLIA-certified laboratory by any owners or operators of the deficient laboratory.Risk factors (Item 1A)

Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COR and 23 more

UK Medicines and Healthcare products Regulatory Agency (MHRA)

subject tonamed as a risk

Post-Brexit, amendments have been made to the existing UK medical devices legislation which require medical devices to be registered with the MHRA before being placed on the Great Britain market.Risk factors (Item 1A)

Also named by ISRG

UK Human Fertilisation and Embryology Authority (HFEA)

subject tonamed as a risk

In addition, we are subject to the UK Human Fertilization & Embryology Association (HFEA) regulating IVF.Risk factors (Item 1A)

China National Medical Products Administration (NMPA)

subject to

Additionally, NMPA generally requires in-country clinical trials to support new product registrations, rather than relying on foreign clinical data.Business (Item 1)

Also named by CYRX, JBL, KVUE, PROF

Japan Ministry of Health, Labour and Welfare (MHLW)

subject to

CooperVision received approval for use of the MiSight 1 day lens in China from Chinese National Medical Products Administration (NMPA) in August 2021 and in Japan from the Japanese Ministry of Health, Labour and Welfare (MHLW) in August 2025.Business (Item 1)

Also named by GH, ISRG, KRYS

Laws and programs

OECD Pillar Two global minimum tax

subject to · 15%named as a risk

The base erosion and profit shifting (BEPS) project undertaken by the Organisation for Economic Co-operation and Development (OECD) includes Pillar Two, a global minimum tax rate of 15% that may adversely affect our provision for income taxes.Risk factors (Item 1A)

Also named by ABNB, ACN, ADI, ADM, ADSK, AKAM, ALB, AMAT and 70 more

EU Medical Device Regulation (EU MDR)

subject tonamed as a risk

If we fail to remain in compliance with applicable EU laws, directives or regulations, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling them within the EU and EEA.Risk factors (Item 1A)

Also named by ABBV, BAX, BDX, BSX, CAH, DXCM, EW, GEHC and 4 more

Clinical Laboratory Improvement Amendments (CLIA)

subject tonamed as a risk

If we were to lose our CLIA certification or required state or foreign licensure, we would not be able to operate our clinical laboratory and conduct our tests, worldwide or in particular jurisdictions, which would adversely impact our diagnostic testing business, operating results, and financial condition.Risk factors (Item 1A)

Also named by DGX, GH, ILMN, IQV, LH, MEDP, NTRA

EU In Vitro Diagnostic Regulation (EU IVDR)

subject tonamed as a risk

Additionally, only a few notified bodies have been designated for EU IVDR certification, which could adversely affect our ability to grow our business.Risk factors (Item 1A)

Also named by A, BDX, CDNA, GH, LH, NTRA

One Big Beautiful Bill Act of 2025 (OBBBA)

subject tonamed as a risk

These changes may affect patient access to care and alter the reimbursement environment for providers and manufacturers.Business (Item 1)

Also named by FSLR, MRVL, NXT, PVLA, TT, WDC

Chinese tariffs on U.S. goods

subject tonamed as a risk

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;Risk factors (Item 1A)

Public Health Service Act Section 361 (HCT/P regulation)

subject tonamed as a risk

However, the FDA could disagree with our determination that these human tissue products are 361 HCT/Ps and could determine that these products are biologics requiring a BLA or medical devices requiring 510(k) clearance or PMA approval, and could require that we cease marketing such products and/or recall them pending appropriate clearance, approval or licensure from the FDA, which would adversely affect our business.Risk factors (Item 1A)

FDA Laboratory Developed Tests (LDT) rule

subject tonamed as a risk

Although since then the FDA has rescinded its prior rule regulating LDTs as medical devices, it is unclear whether the FDA may seek greater oversight of LDTs in other ways, which could increase costs and expenses or otherwise negatively affect our business.Risk factors (Item 1A)

Dobbs reversal of Roe v. Wade (reproductive laws)

subject tonamed as a risk

New and emerging laws may be interpreted to limit access to contraceptive technologies or cryostorage services, which could adversely affect certain aspects of CooperSurgical’s business.Risk factors (Item 1A)

Third-party payors reimbursement

earns fromnamed as a risk

Because our CooperSurgical products are generally purchased by hospitals and surgery centers, OB/GYN medical offices and fertility clinics, and billed to various third-party payors, changes in the purchasing behavior of such customers or the amount such payors are willing to reimburse our customers for procedures using our products, including as a result of healthcare reform initiatives, could create additional pricing pressure on us.Risk factors (Item 1A)