Cooper Companies (COO) 10-K risk factor changes: FY2015 vs FY2014
The 2015-10-31 10-K against the 2014-10-31 one, compared heading by heading and sentence by sentence. One of these filings carries no fiscal year tag, so its year is the calendar year of the period end.
Item 1A62 rewritten33 added18 removed371 unchanged
All filing items848 rewritten469 added365 removed2,128 unchanged
Summary
counted, not written
- Item 1A headings could not be compared: only 0 carried over between the two years, which usually means one filing was read wrongly, so none is reported as new or removed.
- Sentence by sentence, 469 added, 365 removed, 848 rewritten and 2,128 unchanged across 17 items that differ.
Sentences by item
20 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2015; struck-through words were in FY2014. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors.
62 rewritten, 33 added, 18 removed, 371 unchanged
[removed: In] [added: CooperSurgical acquired Reprogenetics in] fiscal [removed: 2014,] [added: 2015,] CooperVision completed the acquisition of Sauflon Pharmaceuticals [removed: Limited, and] [added: Limited] in fiscal [removed: 2012,] [added: 2014, and] CooperSurgical completed the acquisition of Origio [removed: a/s.][added: a/s in fiscal 2012.]
| • | failure to successfully obtain the anticipated revenues, margins and earnings [removed: benefits, including the Sauflon acquisition;] [added: benefits;] |
CooperVision [removed: has been investing] [added: invests] in new product [removed: development since 2005,] [added: development,] including the development of silicone hydrogel-based contact lenses.
In addition, our competitors may have developed or may in the future develop new products or technologies, such as contact lenses with anti-microbial or anti-allergenic features, [added: or “smart” contact lenses which incorporate electronics,] that could lead to the obsolescence of one or more of our products.
Competitors may also introduce new uses for contact [added: lenses, such as for drug delivery or the control of myopia.]
[removed: Failure to] develop new product offerings and technological changes and to offer products that provide performance that is at least comparable to competing products could have a material adverse effect on our business, financial condition, or results of operations.
| • | regulatory [added: and legislative] requirements; |
| • | the earlier release of competitive products, such as [added: new] silicone hydrogel products, into the market by our competitors; and |
A significant portion of our current operations [removed: for CooperVision and our newly acquired Sauflon and Origio businesses] are conducted and located outside the United States, and our growth strategy involves expanding our existing foreign operations and entering into new foreign jurisdictions.
[removed: Approximately two-thirds] [added: Over half] of our net sales for [removed: CooperVision for] the fiscal years ended October 31, [removed: 2014] [added: 2015] and [removed: 2013, respectively,] [added: 2014,] were derived from the sale of products outside the United States.
| • | we may find it difficult to grow in emerging markets such as China, India, [removed: Russia] [added: Russia, Brazil] and other developing nations due to, among other things, customer acceptance, undeveloped distribution channels, regulatory restrictions and changes, and business knowledge of these new markets; |
| • | we may find it difficult to comply with a variety of United States and foreign compliance and regulatory requirements such as the Foreign Corrupt Practices Act, the Dodd-Frank [removed: Act and] [added: Act,] the U.K. Bribery [removed: Act;] [added: Act and international data security and privacy laws;] |
[removed: In] [added: Over] the [added: last few years in the] United States and globally, market and economic conditions have been [removed: unprecedented over the past few years and] challenging with tighter credit conditions and slower economic growth.
As a result, we [removed: continue to] [added: may] have lower than historical [removed: expectations] [added: performance] for market growth in fiscal [removed: 2015.][added: 2016.]
[removed: Continued turbulence particularly in] [added: Any negative impact on economic conditions and] international [removed: markets] [added: markets, continued volatility or deterioration in the debt] and [added: equity capital markets, inflation, deflation or other adverse] economic conditions may adversely affect our liquidity and financial condition, and the liquidity and financial condition of our customers.
[removed: If these market conditions continue, they] [added: It] may limit our ability, and the ability of our customers, to replace maturing liabilities and to access the capital markets to meet liquidity needs, which could have a material adverse effect on our financial condition and results of operations.
Any prolonged disruption in the operations of our existing manufacturing or distribution facilities, whether due to technical or labor difficulties, [added: integration difficulties,] destruction of or damage to any facility (as a result of natural disaster, use and storage of hazardous materials or other events), enforcement action by the FDA or other regulatory body if we are found to be in non-compliance with current Good Manufacturing Practices (cGMP) or other reasons, could have a material adverse effect on our business, financial condition and results of operations.
CooperVision manufactures molded contact lenses, which represent the majority of our contact lens revenues, primarily at our facilities in the United [removed: Kingdom and] [added: Kingdom,] Puerto [removed: Rico.][added: Rico and Hungary.]
Failure to [removed: pass a cGMP, QSR or similar foreign inspection or to] comply with [removed: these] [added: QSR requirements] and other applicable regulatory requirements [added: or to respond to any adverse inspectional observations or product safety issues] could result in disruption of our operations and manufacturing delays in addition to, among other things, [added: warning letters,] significant fines, [added: injunctions,] suspension of approvals, seizures, recalls or import holds of products, operating restrictions and criminal prosecutions.
Both CooperVision and CooperSurgical also rely on [removed: unpatented] proprietary technology [removed: or technology where patents will expire in less than a few years.][added: which is unpatented.]
To protect our trade secrets and other proprietary information, we require employees, consultants, advisors and collaborators to enter into confidentiality agreements and assignment agreements, which generally provide that inventions conceived [added: by the party in the course of rendering services to us will]
| • | cause us to cease making, licensing or [removed: using] [added: selling] products that incorporate the challenged intellectual property; |
We could experience losses from product liability [removed: claims,] [added: claims or legal claims relating to our service offerings,] including such claims and other losses resulting from sales of counterfeit and other infringing products.
Consumers may halt or delay purchases of a product [added: or service] that is the subject of a claim or recall, or has been counterfeited.
There can be no assurance that we will not experience material losses due to product liability claims or recalls, [added: legal claims relating to our service offerings,] or a decline in sales resulting from sales of counterfeit or other infringing products, in the future.
| • | make it more difficult for us to satisfy our obligations with respect to our debt, including our obligation to repay our credit facilities under certain [removed: circumstances.] [added: circumstances, or refinance our indebtedness on favorable terms or at all.] |
In order to maintain our desired mix of fixed-rate and variable-rate debt, we [removed: currently use, and] may [removed: continue to use,] [added: use] interest rate swap agreements and exchange fixed and variable-rate interest payment obligations over the life of the arrangements, without exchange of the underlying principal amounts.
Recently, a number of countries, including the United States, have proposed changes to their [removed: tax laws, some of which affect taxation of earnings recognized in foreign jurisdictions.]
We also have the protections of Section 203 of the Delaware General Corporation Law, which could have [added: similar effects.]
Risks Relating to Government Regulation of Manufacture and Sale of Our Products [added: and Services]
In the United States, the FDA regulates virtually all aspects of a medical device's design, development, testing, manufacture, safety, labeling (including, for [removed: example the upcoming FDA] [added: example,] unique device identifier regulations), storage, recordkeeping, reporting, marketing, [removed: promotion] [added: promotion, advertising] and distribution, as well as [removed: the export of medical devices manufactured in the United States to foreign markets.][added: product import and export.]
Our failure to comply with FDA regulations could lead to the imposition of administrative or judicial sanctions, including injunctions, [added: fines, warning letters,] suspensions or the loss of regulatory approvals, product recalls, termination of distribution or product seizures.
There can be no assurance that such clearances and approvals will be granted on a timely basis, if at all, [removed: or that] [added: and] significant delays in the introduction of any new products or product enhancements [removed: will] [added: may] occur, which could adversely affect our competitive position and results of operations.
In addition, the FDA and [added: authorities in] foreign jurisdictions may change [removed: its] [added: their] policies, adopt additional regulations or revise existing regulations, each of which could prevent or delay premarket approval or clearance of our products or could impact our ability to market our currently approved or cleared products.
For example, the FDA recently has been reviewing the premarket clearance process in response to internal and external concerns regarding the 510(k) [added: premarket clearance] program.
Some of [removed: these] [added: the] changes and proposals under consideration could impose additional regulatory requirements on us that could delay our ability to obtain new 510(k) clearances for our products, increase the cost of compliance, or restrict our ability to maintain our current clearances.
If the FDA requires us to seek clearance or approval for [added: a] modification of a previously cleared product for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing or to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties, which could have [added: a material adverse effect on our financial results and competitive position.]
In the European Economic Area, a medical device can only be placed on the market if it is in conformity with the essential requirements set out in the European Directives and implementing regulations that govern [removed: medical devices.]
After a device is placed on the market, numerous regulatory requirements apply, including the FDA's QSR regulations, which require manufacturers to [removed: follow] [added: follow, among other things,] design, testing, [added: production,] control, documentation and other quality assurance procedures during the manufacturing process; labeling regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling; and medical device reporting regulations that require us to report to FDA or similar governmental bodies in other countries if our products [added: may have caused or contributed to a death or serious injury or] malfunction in a way that would be reasonably likely to contribute to death or serious injury if the malfunction were to recur.
The FDA and similar governmental bodies in other countries have the authority to require the recall of our products in the event of material deficiencies or defects in design or [removed: manufacture.][added: manufacture or in the event that a product poses an unacceptable risk to health.]
Failure to
Foreign countries, in particular the Euro zone, have experienced recessionary pressures and face continued concerns about the systemic impacts of adverse economic conditions and geopolitical issues.
Concerns about the Euro zone’s sovereign debt in recent years have caused uncertainty and disruption in the financial markets globally.
While the global financial markets have showed general signs of improvement, uncertainty remains.
be our exclusive property.
Additionally, we face the inherent risk of exposure to legal claims, including negligence, relating to our provision of certain service offerings, including our genetic testing services and their accuracy.
tax laws, some of which affect taxation of earnings recognized in foreign jurisdictions.
We are just beginning a six year or more process of implementing a new enterprise resource planning (ERP) system at CooperVision.
Implementing a new ERP system is not only costly but complex and difficult.
Implementing a new ERP system can negatively affect not only financial accounting and reporting processes but also external commercial activities such as order receipt and product delivery.
We cannot assure you that we will successfully implement our new ERP system or that we will avoid these and other negative impacts from our implementation efforts.
Increased regulatory scrutiny and negative opinion of genetic testing may adversely affect our business through increased costs and risks associated with gaining marketing approvals and potential decreased demand for our genetic testing services.
With our acquisition of Reprogenetics in August 2015, we now offer certain genetic testing services to help identify the likelihood of pregnancy as well as identify possible disorders or diseases of a child prior to birth.
Legislative proposals addressing oversight of genetic testing have been introduced in the United States, and we expect that new legislative proposals will be introduced from time to time both in the United States and in foreign countries in the future.
We cannot provide any assurance that FDA regulation or regulation by foreign regulatory authorities, including pre-market review, will not be required for our genetic tests in the future or that other increased regulatory burdens will not be imposed on our genetic tests or any new genetic tests we may develop.
If pre-market review is required, our genetic test business will be negatively impacted until such review is completed and approval or clearance is obtained, and the FDA or other foreign regulatory authorities may require that we stop selling our genetic tests pending pre-market approval or clearance.
In addition to these regulatory burdens, our ability to sell our genetic tests may be negatively impacted by public perception and social or cultural norms.
The information obtained from our genetic tests could be used in a variety of applications, which may have underlying ethical, legal, and social concerns regarding privacy and the appropriate uses of the resulting information which in turn may result in increased regulation and/or decreased demand.
medical devices.
The FDA requires that certain classifications of recalls be reported to the FDA within 10 working days after the recall is initiated.
| • | Reporting and disclosure requirements on medical device manufacturers for certain payments or other “transfer of value” made or distributed to prescribers and other healthcare providers, and any ownership |
and investment interests held by physicians or their immediate family members, and any payments or other “transfers of value” to such owners.
Manufacturers are required to submit reports to the Centers for Medicare & Medicaid Services (CMS) by the 90th day of each calendar year;
In addition, on April 16, 2015, President Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015, or MACRA, which among other things, repealed the formula by which Medicare made annual payment adjustments to physicians and replaced the former formula with fixed annual updates and a new system of incentive payments scheduled to begin in 2019 that are based on various performance measures and physicians’ participation in alternative payment models such as accountable care organizations.
Although cost controls or other
The Final Omnibus Privacy, Security, Breach Notification and Enforcement Rules (Omnibus Final Rule), implementing HIPAA and HITECH, became effective in September 2013.
While there is no private right of action under HIPAA that would allow individuals to sue in civil court for violations, HIPAA’s standards have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in misusing individuals’ health information.
Further, varying state laws governing the use and disclosure of PII may be more restrictive than HIPAA, which means that entities subject to them must comply with the more restrictive state law in addition to complying with HIPAA.
In some cases, a breach may be required to be reported under state law and affected individuals notified, even if the breach is not reportable or subject to breach notification requirements under HIPAA.
State laws may impose separate fines and penalties upon violators, and some, unlike HIPAA, may afford a private right of action to state residents who believe their information has been misused.
However, many of our customers may be covered entities or business associates subject to HIPAA.
ility on us for failure to meet our contractual obligations.
If the government determines that we are a covered entity or a business associate, we could be faced with additional costs related to HIPAA compliance and subject to governmental enforcement for failure to comply with HIPAA, which could have a material adverse effect on our business, financial condition and results of operations and reputation.
lenses, such as for drug delivery or the control of myopia.
In addition, we have been slower to introduce new silicone hydrogel contact lens products than our competitors which put these products at a competitive disadvantage.
The U.S. economy has experienced a recession and faces continued concerns about the systemic impacts of adverse economic conditions such as the growing U.S. deficit, high energy costs, geopolitical issues, the availability and cost of credit, and an unstable real estate market.
Foreign countries, in particular the Euro zone, are affected by similar systemic impacts.
Through the Sauflon acquisition, CooperVision acquired manufacturing facilities in the United Kingdom and Hungary.
by the party in the course of rendering services to us will be our exclusive property.
similar effects.
a material adverse effect on our financial results and competitive position.
For example, CooperVision recently concluded a recall of limited lots of Avaira Toric contact lenses and Avaira Sphere contact lenses.
In addition, the
| • | New reporting and disclosure requirements on medical device manufacturers for any “transfer of value” made or distributed to prescribers and other healthcare providers, and any ownership and investment interests held by physicians or their immediate family members, and any payments or other “transfers of value” to such owners. Manufacturers were required to begin data collection on August 1, 2013 and were required to report such data to the government by March 31, 2014 and in future periods by the 90th calendar day of each year thereafter; |
Some customers as an expectation of transacting business with us may require us to enter into business associate
Pursuant to the HITECH Act, if the government determines that we are a business associate, we could be additionally subject to direct governmental enforcement for failure to comply with certain privacy and security requirements.
In addition, the final omnibus rule released in January 2013, among other things, modifies the breach reporting standard in a manner that will likely make more data security incidents qualify as reportable breaches.
The costs of complying with these contractual obligations and new legal and regulatory requirements, and the potential liability associated with failure to do so could have a material adverse effect on our business, financial condition and results of operations.
To the extent HIPAA is applicable to certain ancillary practice management software services offered to eye care professionals, we believe those offerings are HIPAA compliant.
The Advanced Medical Technology Association (AdvaMed), a trade association representing the interests of medical device manufacturers, has also released a revised code of ethics outlining permissible interactions with health care professionals.
This code became effective July 1, 2009.
An excerpt. Shown here: 40 of 62 rewritten, all 33 added and all 18 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors. in the FY2015 filing and the FY2014 filing.
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.
159 rewritten, 134 added, 82 removed, 337 unchanged
We discuss below the results of our operations for fiscal [removed: 2014] [added: 2015] compared with fiscal [removed: 2013] [added: 2014] and the results of our operations for fiscal [removed: 2013] [added: 2014] compared with fiscal [removed: 2012.][added: 2013.]
[added: We discuss our cash flows and current financial condition under “Capital Resources and Liquidity.”] Certain prior period amounts have been reclassified to conform to the current period's presentation.
However, events affecting the economy as a whole, including the uncertainty and instability of global markets driven by [removed: United States and] [added: foreign currency volatility,] European debt [removed: concerns,] [added: concerns and] the Affordable Care Act, including the trend of consolidation within the healthcare industry, [removed: and the economic downturn in Japan together with foreign currency volatility, particularly the yen, euro and the pound,] impact our current performance and continue to represent a risk to our performance for fiscal year [removed: 2015.][added: 2016.]
CooperVision - We compete in the worldwide contact lens market with our spherical, toric and multifocal contact lenses offered in a variety of materials including using silicone hydrogel Aquaform® technology and phosphorylcholine [removed: technology] (PC) Technology™.
Sales of contact lenses utilizing silicone hydrogel [removed: materials, a major] [added: materials continue to grow and this] product material [removed: in] [added: represents about half of] the [removed: industry, have grown significantly.][added: industry.]
CooperVision markets monthly and two-week silicone hydrogel spherical and toric lens products under our [removed: Biofinity®] [added: Biofinity®, clariti®] and Avaira® [removed: brands, a monthly multifocal silicone hydrogel lens under Biofinity] [added: brands] and a [removed: single-use spherical] [added: monthly] silicone hydrogel [added: multifocal] lens under [removed: MyDayTM.][added: Biofinity.]
We believe that the global market for single-use contact lenses will continue to grow and [removed: that competitive] [added: our single-use] silicone hydrogel [removed: single-use] products [removed: are gaining market share and that they] represent [removed: a risk to] [added: an opportunity for] our business.
We forecast increasing [added: aggregate] demand for [removed: our] existing and future single-use products.
To meet this anticipated demand, in fiscal [removed: 2015] [added: 2016] we plan to continue the implementation of capital projects to invest in increased single-use manufacturing capacity.
[removed: Consistent with this strategy, on] [added: On] August 6, 2014, we acquired Sauflon Pharmaceuticals Limited (Sauflon), a privately-held European manufacturer and distributor of soft contact lenses and aftercare solutions.
The acquisition of Sauflon [removed: expands] [added: expanded] our contact lens product portfolio particularly with Sauflon's clariti® 1day brand of single-use [removed: sphere,] [added: silicone hydrogel spherical,] toric and multifocal [removed: silicone hydrogel] lenses.
[removed: CooperSurgical has steadily grown its market presence and distribution system] by developing products and acquiring companies and products that complement its business model.
We paid [removed: $44.0] [added: $46.8] million for [removed: EndoSee] [added: Reprogenetics] and expect the acquisition to be neutral to earnings per share excluding acquisition costs and related [removed: amortization.][added: amortization through fiscal 2016.]
CooperSurgical product sales are categorized based on the point of healthcare delivery including products used in medical office and surgical procedures by obstetricians and gynecologists (ob/gyns) that represented [removed: 65%] [added: 66%] of CooperSurgical's net sales in fiscal [removed: 2014.][added: 2015.]
CooperSurgical's remaining sales are products used in fertility clinics that now represent [removed: 35%] [added: 34%] of CooperSurgical's net sales compared to [removed: 33%] [added: 35%] in fiscal [removed: 2013.][added: 2014.]
At October 31, [removed: 2014,] [added: 2015,] we had [removed: $25.2] [added: $16.4] million in cash, primarily outside the United States, and [removed: $720.3] [added: $890.8] million available under our existing revolving Credit Agreement.
The $700.0 million term loan entered into on August 4, 2014, and the $300.0 million term loan entered into on September 12, 2013, remain outstanding as of October 31, [removed: 2014.][added: 2015.]
[removed: Looking forward, our] [added: Our current] cash [added: balance] and availability under existing credit facilities [removed: will be reduced due to] [added: reflects] the use of cash outside the United States and the use of existing credit facilities to fund the [added: $1.1 billion] acquisition of [removed: Sauflon.][added: Sauflon in August 2014.]
We believe that our cash and cash equivalents, cash flow from operating activities and borrowing capacity under existing credit [removed: facilities, including the August 4, 2014, $700.0 million term loan,] [added: facilities] will fund operations both in the next 12 months and in the longer term as well as current and long-term cash requirements for capital expenditures, acquisitions, share repurchases and cash dividends.
Our consolidated net sales grew by $130.0 million [added: or 8%] in fiscal 2014 and $142.6 million [added: or 10%] in [added: fiscal] 2013:
Significantly, the market for spherical lenses is growing with value-added [removed: spherical lenses to]
[added: spherical lenses to] alleviate dry eye [removed: symptoms as well as lenses with] [added: symptoms, to add] aspherical optical properties [removed: or] [added: and/or] higher oxygen permeable lenses such as silicone hydrogels.
CooperVision’s [removed: Biofinity brand] silicone hydrogel [added: Biofinity brand] spherical, toric and multifocal contact lenses, Avaira brand spherical and toric products and [removed: MyDay, our silicone hydrogel single-use products,] [added: MyDay brand spherical lenses] are manufactured using proprietary Aquaform technology to increase oxygen transmissibility for longer wear.
| ($ in millions) | 2014 | | | | 2013 | | | | [added: 2014 vs. 2013] % Change | |
| Americas | $ | [removed: 585.2] [added: 585.6] | | | $ | 546.2 | | | 7 | % |
| EMEA | [removed: 533.9] [added: 533.5] | | | | 439.4 | | | | 22 | % |
Americas net sales [removed: grew 7%,] [added: growth was] primarily due to market gains of [removed: CooperVision’s] silicone hydrogel contact lenses along with single-use sphere and multifocal products.
EMEA net sales [removed: increased 22%] [added: growth was] primarily driven by increased sales of silicone hydrogel lenses including Sauflon's silicone hydrogel single-use products.
Net sales to the Asia Pacific region decreased [removed: 3%] due to the negative impact of the weakening of the Japanese yen compared to the United States dollar.
CooperSurgical [removed: participates in] [added: supplies] the market for women's healthcare with its diversified [removed: product lines used] [added: portfolio of products for use] in [removed: fertility procedures] [added: surgical] and [added: other medical procedures that are performed] by [removed: gynecologists and] obstetricians [added: and gynecologists] in [added: hospitals,] surgical [removed: procedures] [added: centers, fertility clinics] and in the medical office.
| Year Ended October 31, ($ in millions) | | 2014 | | | | % Net Sales | | | 2013 | | | | % Net Sales | | | [added: 2014 vs. 2013] % Change | |
The decline in net sales of medical office and surgical procedures [removed: by ob/gyns] was primarily due to declines in sales of medical equipment offset in part by growth in sales of disposable products.
CooperSurgical’s sales primarily [removed: comprise] [added: include] women’s healthcare products used in fertility procedures and by gynecologists and obstetricians in [removed: surgical procedures] [added: office] and [removed: in the medical office.][added: surgical procedures.]
| • | Net sales up [removed: 10%] [added: 5%] to [removed: $1.6] [added: $1.80] billion from [removed: $1.4] [added: $1.72] billion in fiscal year [removed: 2012] [added: 2014] |
| • | Gross margin [removed: 65%] [added: 60%] of net sales [removed: up] [added: down] from 64% |
| • | Operating income [removed: up 8%] [added: down 23%] to [removed: $305.9] [added: $236.7] million from [removed: $283.4] [added: $306.5] million |
| • | Diluted earnings per share [removed: up 18%] [added: down 25%] to [removed: $5.96] [added: $4.14] from [removed: $5.05] [added: $5.51] |
| • | Operating cash flow [removed: $415.9] [added: $391.0] million [removed: up 32%] [added: down 14%] from [removed: $315.1] [added: $454.8] million |
| Years Ended October 31, | [removed: 2013] [added: 2015] | | | [removed: 2013] [added: 2015] vs. [removed: 2012] [added: 2014] % Change | | | [removed: 2012] [added: 2014] | | | [removed: 2012] [added: 2014] vs. [removed: 2011] [added: 2013] % Change | | | [removed: 2011] [added: 2013] | |
| Net sales | 100 | % | | [removed: 10] [added: 5] | % | | 100 | % | | [removed: 9] [added: 8] | % | | 100 | % |
Within the tables presented, percentages are calculated based on the underlying whole-dollar amounts and, therefore, may not recalculate from the rounded numbers used for disclosure purposes.
CooperVision markets single-use spherical, toric and multifocal lenses under our clariti 1day brand and a single-use silicone hydrogel spherical lens under MyDay®.
Our clariti 1day brand provides the only single-use silicone hydrogel lenses in the marketplace with a complete line of spherical, toric and multifocal contact lenses.
We forecast increasing aggregate demand for clariti 1day, MyDay, and Proclear 1 Day products, as well as future single-use products.
To meet this anticipated demand, we plan to continue the implementation of capital projects to invest in increased single-use manufacturing capacity.
CooperSurgical has established its market presence and distribution system
In August 2015, CooperSurgical acquired Reprogenetics, a genetics laboratory specializing in preimplantation genetic screening (PGS) and preimplantation genetic diagnosis (PGD) used during the in vitro fertilization (IVF) process.
Capital Resources - At October 31, 2015, we had $16.4 million in cash, primarily outside the United States, and $890.8 million available under our revolving Credit Agreement.
On March 24, 2015, we entered into two new uncommitted revolving lines of credit with a termination date of March 24, 2016, and a maximum combined capacity of $200.0 million.
At October 31, 2015, all $200.0 million was outstanding and the proceeds had been utilized to pay down higher interest rate debt on our revolving Credit Agreement.
On July 14, 2015, CooperVision made a one-time lump sum payment to JJVC of $17.0 million to settle our existing patent disputes.
As discussed in Note 12 of the notes to consolidated financial statements, the settlement was royalty-free and neither party admitted any liability.
On April 7, 2015, we paid all of the outstanding loan notes issued to previous holders of Sauflon shares for the Sauflon acquisition in the amount of $51.2 million that had been recorded in short-term debt.
2015 Compared with 2014
| • | Interest expense increased to $18.1 million from $8.0 million |
Fiscal 2015 pre-tax results include $51.5 million for amortization of intangible assets and $126.4 million of acquisition, integration and restructuring costs primarily related to the acquisition of Sauflon as well as certain legal costs.
Acquisition related and integration expenses include items such as personnel costs for transitional employees, other acquired employee related costs and integration related professional services.
The fiscal 2015 results include $57.8 million of expenses primarily due to product and equipment rationalization related to recent acquisitions, $8.0 million of costs associated with the start-up of new manufacturing facilities, and $4.5 million of severance costs, all recorded in cost of sales.
Included in our selling, general and administrative expense is $31.7 million in costs for CooperVision's acquisition of Sauflon and the related integration and restructuring activities, severance costs in our CooperSurgical fertility business along with other acquisition costs; and $19.8 million of legal costs.
The legal costs include a $17.0 million settlement related to intellectual property claims by Johnson & Johnson Vision Care (JJVC) as well as litigation costs relating to the class action complaints filed against CooperVision and other contact lens manufacturers, distributors and retailers relating to Unilateral Pricing Policy (UPP).
Research and development expense includes $4.6 million of integration and restructuring activities primarily for equipment rationalization along with severance costs.
The charge for product rationalization was based on our review of products, materials and manufacturing processes of Sauflon.
Included in our selling, general and administrative expense is $44.5 million in costs for CooperVision's acquisition of Sauflon and the related integration and restructuring activities, severance costs in our CooperSurgical fertility business along with other acquisition costs.
| CooperVision | $ | 95.1 | | | 7 | % | | $ | 124.3 | | | 10 | % |
| CooperSurgical | (15.8 | | ) | | (5 | )% | | 5.7 | | | | 2 | % |
| | $ | 79.3 | | | 5 | % | | $ | 130.0 | | | 8 | % |
Our silicone hydrogel clariti brand spherical, toric and multifocal contact lenses are available in monthly and single-use modalities.
We believe the clariti single-use silicone hydrogel lens products provide a competitive advantage in approved markets as clariti is the only single-use silicone hydrogel lens available in all vision correction categories - spherical, toric and multifocal.
CooperVision fiscal 2015 net sales increased 7% from fiscal 2014 to $1.49 billion.
Total toric lenses grew 3%, representing 30% of net sales, compared to 31% in the prior year on sales of Biofinity, clariti and Avaira lenses.
| ($ in millions) | 2015 | | | | 2014 | | | | 2015 vs. 2014 % Change | |
| Americas | $ | 624.3 | | | $ | 585.6 | | | 7 | % |
| EMEA | 602.1 | | | | 533.5 | | | | 13 | % |
| Asia Pacific | 261.4 | | | | 273.5 | | | | (4 | )% |
| | $ | 1,487.8 | | | $ | 1,392.6 | | | 7 | % |
CooperVision fiscal 2015 net sales growth was partially offset by foreign exchange rate fluctuations, which decreased net sales by $138.4 million.
The increase in EMEA net sales was partially offset by the negative impact from the weakening of foreign currencies as compared to the United States dollar.
CooperSurgical supplies the market for women's healthcare with a diversified portfolio of products for use in surgical and other medical procedures that are performed primarily by obstetricians and gynecologists in hospitals, surgical centers, fertility clinics and in the medical office.
| Year Ended October 31, ($ in millions) | | 2015 | | | | % Net Sales | | | 2014 | | | | % Net Sales | | | 2015 vs. 2014 % Change | |
| Office and surgical procedures | | $ | 204.1 | | | 66 | % | | $ | 211.9 | | | 65 | % | | (4 | )% |
We discuss our cash flows and current financial condition under “Capital Resources and Liquidity.”
We compete with MyDay, our single-use spherical silicone hydrogel lens, and our Proclear 1 Day products including Proclear® 1 Day multifocal.
Clariti lenses received United States FDA clearance in August 2013.
Sauflon is headquartered in the United Kingdom and has a global presence with manufacturing facilities in the United Kingdom and Hungary.
We paid approximately $1,131.1 million for Sauflon, consisting of approximately $1,073.2 million in cash and approximately $58.0 million in the form of loan notes.
We financed the acquisition with available offshore cash and credit facilities along with funds from the new $700.0 million term loan facility described below and in the notes to consolidated financial statements.
We are in the process of determining the purchase price allocation for this acquisition which is described in more detail in the notes to consolidated financial statements.
The Sauflon acquisition is intended to accelerate the growth in sales of our single-use products by enabling a multi-tier, single-use strategy with a full suite of hydrogel and silicone hydrogel product offerings in the major product categories of sphere, toric and multifocal lenses.
This acquisition is also intended to provide for enhanced relationships with key European retailers and opportunities for operational synergies.
In October 2014, CooperSurgical acquired EndoSee Corporation, a developer of an office-based disposable hysteroscopy system that has FDA clearance.
Capital Resources - On August 4, 2014, we entered into a three-year, $700.0 million senior unsecured term loan agreement by and among the Company, the lenders party thereto and KeyBank National Association as administrative agent.
This syndicated credit facility will mature and the balance is payable on August 4, 2017.
There is no amortization of principal and we may prepay loan balances from time to time, in whole or in part, without premium or penalty.
We utilized this facility to fund the acquisition of Sauflon Pharmaceuticals Limited, as well as to provide working capital and for general corporate purposes.
In our fiscal fourth quarter of 2014, we completed the acquisition of Sauflon for $1.13 billion, discussed above.
The contact lens market consists primarily of single-use and frequently replaced lenses.
We believe the clariti single-use silicone hydrogel lens products acquired with Sauflon are important to address increased pressure from multifocal and single-use silicone hydrogel products offered by our major competitors.
2013 Compared with 2012
Highlights: 2013 vs. 2012
| • | Interest expense down 22% to $9.2 million from $11.8 million |
Fiscal 2013 pre-tax results included $30.2 million for amortization of intangible assets, a $21.1 million loss on divestiture of Aime, $14.1 million of insurance proceeds related to a business interruption claim and $0.6 million of costs related to the acquisition of Origio.
Fiscal 2012 pre-tax results included $24.0 million for amortization of intangible assets, a $1.4 million loss related to the May 31, 2012, amendment to our revolving Credit Agreement, and costs related to the acquisition of Origio consisting of $4.9 million in direct acquisition costs and a $0.4 million net gain related to the repayment of debt acquired recorded in interest expense.
| CooperVision | $ | 79.1 | | | 7 | % | | $ | 68.1 | | | 6 | % |
| CooperSurgical | 63.5 | | | | 25 | % | | 46.2 | | | | 22 | % |
| | $ | 142.6 | | | 10 | % | | $ | 114.3 | | | 9 | % |
Proclear product sales grew 6% as compared to the prior year and represented 25% of net sales, the same as the prior year.
| ($ in millions) | 2013 | | | | 2012 | | | | % Change | |
| Americas | $ | 546.2 | | | $ | 498.9 | | | 9 | % |
| EMEA | 439.4 | | | | 402.3 | | | | 9 | % |
| Asia Pacific | 282.7 | | | | 288.0 | | | | (2 | )% |
| | $ | 1,268.3 | | | $ | 1,189.2 | | | 7 | % |
CooperVision’s fiscal 2013 worldwide net sales grew 7% in the year-to-year comparison.
CooperSurgical’s fiscal 2013 net sales increased 25% from fiscal 2012 to $319.4 million with net sales growth excluding acquisitions of 3%.
Sales of products used in fertility clinics now represent 33% of net sales compared to 16% in the prior year due to the acquisition of Origio in July 2012.
Acquisition of Origio: On July 11, 2012, we completed a voluntary tender offer for the outstanding shares of Origio a/s at a purchase price of Norwegian krone (NOK) 28 per share in cash, or $147.4 million, and acquired about 97% of the outstanding shares.
During our fiscal fourth quarter of 2012 and our fiscal first
quarter of 2013, we completed a mandatory redemption to obtain the remaining shares in accordance with the Danish Companies Act.
We, through our subsidiaries, financed the acquisition with available offshore cash and credit facilities.
Based in Malov, Denmark, Origio had approximately 320 employees.
We assumed about $45.4 million of Origio's debt that we repaid concurrent with the acquisition.
An excerpt. Shown here: 40 of 159 rewritten, 40 of 134 added and 40 of 82 removed. The counts are complete. For every sentence, read Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations. in the FY2015 filing and the FY2014 filing.
Item 7A. Quantitative and Qualitative Disclosure about Market Risk.
17 rewritten, 6 added, 6 removed, 27 unchanged
[removed: Our policy is to reduce, to] [added: To] the extent reasonable and practical, [removed: its exposure] [added: we may decide] to [added: reduce] the [removed: impact] [added: risk] of changing interest rates and foreign currency fluctuations [added: on the underlying exposure] by entering into [removed: a limited number of] interest rate swaps and foreign currency forward exchange contracts, respectively.
We [removed: have decreased] [added: may decrease] this interest rate risk by hedging a portion of variable rate debt effectively converting it to fixed rate [removed: debt for varying periods through December 2014.][added: debt.]
There is no amortization of the principal, and we may prepay the loan balances from time to time, in whole or in part, [removed: with] [added: without] premium or penalty.
At October 31, [removed: 2014,] [added: 2015,] $700.0 million remained outstanding on this term loan.
At October 31, [removed: 2014,] [added: 2015,] $300.0 million remained outstanding on this term loan.
[removed: In addition,] [added: The aggregate revolving commitment is $1.0 billion with a maturity date of May 31, 2017, and] we have the ability to increase the facility by up to an additional $500.0 million.
At October 31, [removed: 2014,] [added: 2015,] we had [removed: $720.3] [added: $890.8] million available under the revolving Credit Agreement.
| October 31, (In millions) | [removed: 2014] [added: 2015] | | | | [removed: 2013] [added: 2014] | | |
| Short-term debt | $ | [removed: 101.5] [added: 240.4] | | | $ | [removed: 43.0] [added: 101.5] | |
| Long-term debt | [removed: 1,280.8] [added: 1,105.8] | | | | [removed: 301.7] [added: 1,280.8] | | |
| Total | $ | [removed: 1,382.3] [added: 1,350.0] | | | $ | [removed: 344.7] [added: 1,382.3] | |
At October 31, [removed: 2014,] [added: 2015,] the scheduled maturities of our fixed and variable rate long-term debt obligations, their weighted average interest rates and their estimated fair values were as follows:
| Expected Maturity Date Fiscal Year ($ in millions) | [removed: 2015 | | | |] 2016 | | | | 2017 | | | | 2018 | | | | 2019 | | | | [added: 2020 | | | |] Thereafter | | | | Total | | | | Fair Value | | |
| Fixed interest rate | $ | — | | | $ | [removed: 0.4] [added: 0.1] | | | $ | [removed: 0.3] [added: 0.1] | | | $ | [removed: 0.3] [added: —] | | | $ | — | | | $ | 0.3 | | | $ | [removed: 1.3] [added: 0.5] | | | $ | [removed: 1.3] [added: 0.5] | |
| Average interest rate | [removed: 3.5] [added: 1.3] | | % | | [removed: 3.5] [added: 1.3] | | % | | [removed: 3.5] [added: 1.3] | | % | | [removed: 3.5] [added: —] | | [removed: %] | | [removed: 3.5] [added: —] | | [removed: %] | | [removed: 3.5] [added: —] | | [removed: %] | | | | | | | | |
As the table incorporates only those exposures that existed as of October 31, [removed: 2014,] [added: 2015,] it does not consider those exposures or positions which could arise after that date.
If interest rates were to increase or decrease by 1% or 100 basis points, annual interest expense would increase or decrease by about [removed: $12.8] [added: $11.1] million.
On March 24, 2015, we entered into two uncommitted line of credit agreements that have termination dates of March 24, 2016, and provide revolving loan amounts of up to $100.0 million each with maturity dates of up to ninety days from the loan origination date.
At October 31, 2015, $200.0 million was outstanding under these facilities.
| Current portion of long-term debt | 3.8 | | | | — | | |
| Average interest rate | 2.9 | | % | | 3.4 | | % | | 4.3 | | % | | — | | | | — | | | | 6.0 | | % | | | | | | | | |
| Variable interest rate | $ | 3.8 | | | $ | 824.0 | | | $ | 281.3 | | | $ | — | | | $ | — | | | $ | — | | | $ | 1,109.1 | | | $1,109.1 | | |
As of October 31, 2015, we had no interest rate swap outstanding.
The aggregate revolving commitment was increased to $1.0 billion from $750.0 million.
This facility offers additional availability, lower interest rates and extends the maturity date to May 31, 2017, from January 12, 2016.
KeyBank led the refinancing with certain banks that participated in the Credit Agreement retaining or increasing their participation.
| Variable interest rate | $ | — | | | $ | — | | | $ | 979.5 | | | $ | 300.0 | | | $ | — | | | $ | — | | | $ | 1,279.5 | | | $1,279.5 | | |
| Average interest rate | 1.0 | | % | | 1.0 | | % | | 1.0 | | % | | 1.0 | | % | | — | | | | — | | | | | | | | | | |
As of October 31, 2014, we had one interest rate swap outstanding that is designed to fix the variable borrowing costs related to $40.0 million of the outstanding balance on our credit agreements.
Item 1. Business.
75 rewritten, 27 added, 28 removed, 205 unchanged
[removed: This increased] [added: We believe that this] manufacturing flexibility [removed: should allow] [added: allows] CooperVision to compete in its markets by:
Sales of contact lenses utilizing silicone hydrogel [removed: materials, a major] [added: materials continue to grow and this] product material [removed: in] [added: represents about half of] the [removed: industry, have grown significantly.][added: industry.]
We believe our ability to compete successfully with a full range of silicone hydrogel products is an important factor to achieving [added: success in] our [removed: desired future levels of sales growth and profitability.][added: business.]
We believe that the global market for single-use contact lenses will continue to [removed: grow,] [added: grow and] that competitive silicone hydrogel single-use lens products [removed: are gaining market share and that they] represent [removed: a risk to] [added: an opportunity for] our business.
[removed: The acquisition of Sauflon expands our contact lens product portfolio particularly with Sauflon's clariti®] [added: Our clariti] 1day brand [removed: of] [added: provides the only] single-use [removed: sphere,] [added: silicone hydrogel lenses in the marketplace with a complete line of spherical,] toric and multifocal [removed: silicone hydrogel] [added: contact] lenses.
CooperVision's [removed: Proclear®] [added: Proclear] line of spherical, toric and multifocal lenses are manufactured with omafilcon, a material that incorporates Phosphorylcholine (PC) Technology™ that helps enhance tissue-device compatibility.
[added: Mild discomfort relating to dryness during lens wear is a condition that often causes patients to discontinue contact lens wear and] Proclear lenses are the only lenses with FDA clearance for the claim "… may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms relating to dryness during lens wear." [removed: Mild discomfort relating to dryness during lens wear is a condition that often causes patients to discontinue contact lens wear.]
Spheres: Net sales of CooperVision's spherical lenses represented [removed: 56] [added: 55] percent of CooperVision's net sales in fiscal [removed: 2014] [added: 2015] including net sales of single-use spherical lens that represented [removed: 22] [added: 24] percent of net sales in the fiscal year.
Toric and Multifocal: Net sales of CooperVision's toric lenses represented [removed: 31] [added: 30] percent of CooperVision's net sales in fiscal [removed: 2014.][added: 2015.]
Proclear: Net sales of CooperVision's PC Technology [removed: products - which consist of] spherical, toric and multifocal products, including [removed: Biomedics® XC and Proclear®] [added: Proclear] 1 Day [removed: -] [added: sphere and multifocal products,] represented [removed: 24] [added: 21] percent of CooperVision's net sales in fiscal [removed: 2014.][added: 2015.]
Silicone Hydrogel: CooperVision's silicone hydrogel spherical, toric and multifocal lens products, including [removed: Sauflon's] clariti [removed: lenses in the fiscal fourth quarter of 2014] and [removed: not in fiscal 2013,] [added: MyDay products,] represented [removed: 49] [added: 55] percent of CooperVision's net sales [removed: as compared to 43 percent] in fiscal [removed: 2013.][added: 2015.]
CooperVision competes in the silicone hydrogel segment of the market with our Biofinity monthly spherical, toric and multifocal lenses, [removed: Avaira] [added: Avaira®] two-week spherical and toric [removed: lenses] [added: lenses, clariti 1day brand of single-use sphere, toric] and [added: multifocal lenses, and] MyDay single-use spherical lenses.
[removed: We believe that the addition of Sauflon's] [added: The] clariti 1day [removed: brand] [added: and MyDay brands] of single-use [removed: sphere, toric and multifocal] [added: contact] lenses provides CooperVision with the broadest product portfolio in the single-use silicone hydrogel market.
CooperVision competes based on [added: the fact that] its three manufacturing processes, including [added: the clariti] manufacturing [removed: processes] [added: platform] recently acquired with Sauflon, [removed: yielding wider ranges] [added: allows a broad range] of toric lens parameters, [removed: providing] [added: which we believe provides] wide choices for patient and practitioner and [removed: superior visual acuity, as well as by offering excellent customer service, including] [added: a] high [removed: standards] [added: level] of [removed: on-time product delivery.][added: visual acuity.]
CooperVision's primary competitors [added: in the contact lens business] have greater financial [removed: resources and] [added: resources,] larger research and development [removed: budgets and] [added: budgets, larger] sales [removed: forces.][added: forces, greater market penetration and/or larger manufacturing volumes.]
CooperVision seeks to offer a high level of customer service through its direct sales organizations around the world and through telephone sales and technical service representatives who consult with eye care professionals about the use of [removed: the Company's] [added: our] lens products.
CooperVision believes that [removed: its contact lenses will continue to compete favorably against eyeglasses and] 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.
CooperVision also believes that laser vision correction is not a significant threat to its sales of contact [removed: lenses.][added: lenses based on the growth of the contact lens market over the past decade.]
The Company participates in the women's healthcare market [removed: through offering] [added: seeking to offer] quality products, innovative technologies and superior service to clinicians worldwide.
The result is a broad portfolio of products that [added: are intended to] aid in the delivery of improved clinical outcomes that healthcare professionals use routinely in the diagnosis and treatment of a wide spectrum of women's health issues.
Since its inception in 1990, CooperSurgical has [removed: steadily grown] [added: established] its market presence and distribution system by developing products and acquiring products and companies that complement its business model.
CooperSurgical competes in the global in-vitro fertilization (IVF) market with a product portfolio of IVF media and assisted reproductive technology [removed: (ART)] solutions [removed: that] [added: designed to] enhance the work of fertility professionals to the benefit of families.
Driving this growth is a steady number of reproductive age women with increasing fertility issues, a large and stable middle-aged population and a growing population of women over the age of 65 according [removed: the] [added: to] United States Census estimates.
Office visit activity related to [removed: menopausal problems,] [added: menopause,] including abnormal bleeding, incontinence and osteoporosis, are also expected to increase slightly over the next decade.
CooperSurgical believes that [removed: in the] past [added: trends reflected women visiting] clinicians primarily [removed: saw women only] during their reproductive years.
[removed: Now, with] [added: With] new treatment options [added: now] available and a more educated population, CooperSurgical expects the relationship between the patient and clinician will continue into the middle years and later.
The response in the United States market to the [added: Patient Protection and] Affordable Care [added: Act, as amended by the Health Care and Education Reconciliation] Act [removed: (ACA)] [added: (Affordable Care Act or ACA)] includes the development of new models of healthcare delivery.
While general medical practitioners play an important role in women's primary care, the ob/gyn specialist is the primary market for [removed: CooperSugical's] [added: our] medical devices.
| • | We [removed: estimate] [added: believe] that approximately one-third of the office visits to ob/gyns are patients seeking diagnosis and treatment for the symptoms of abnormal uterine bleeding. |
| • | Ob/gyns traditionally provide the initial evaluation for women and their partners who seek infertility assistance. Ovulatory drugs and intrauterine insemination (IUI) are common treatments in these [removed: cases along with embryo transfer procedures.] [added: cases.] |
| • | Sterilization is a frequently performed [removed: surgical] procedure. |
| • | [removed: Hysterectomy,] [added: Hysterectomy is] one of the most commonly performed surgical [removed: procedures, is increasingly performed using a laparoscopic approach.] [added: procedures.] |
[removed: Woman's] [added: Women's] Healthcare Product Sales
Net sales of CooperSurgical products used in office and surgical [removed: procedures, representing 65%] [added: procedures represented 66%] of CooperSurgical's net [removed: sales, decreased 1%] [added: sales] in fiscal [removed: 2014 as compared to fiscal 2013.][added: 2015.]
Net sales of fertility [removed: products, representing 35%] [added: products represented 34%] of CooperSurgical's net [removed: sales, grew 7%] [added: sales] in fiscal [removed: 2014 as compared to fiscal 2013.][added: 2015.]
CooperSurgical competes based on our sales and marketing expertise and the technological [added: advantages of our products.]
As CooperSurgical expands [removed: our] [added: its] product line, we also offer educational programs for medical professionals in the appropriate use of our products.
CooperSurgical is seeking to expand our presence in the significantly larger hospital and outpatient surgical procedure segment of the market that is at present dominated by bigger competitors such as Johnson & Johnson's Ethicon Endo-Surgery, Boston Scientific, [removed: Gyrus ACMI] [added: Olympus] and Covidien.
Cooper employs [removed: about 250] [added: approximately 215] people in our research and development and manufacturing engineering departments.
Cooper-sponsored research and development expenditures [added: represented 4% of net sales] during fiscal [removed: 2014, 2013] [added: 2015, 2014] and [removed: 2012] [added: 2013, and] were [removed: $66.3] [added: $69.6] million, [removed: $58.8] [added: $66.3] million and [removed: $51.7] [added: $58.8] million, respectively.
The clariti® manufacturing platform may continue to add greater flexibility to the manufacture of our product offerings.
CooperVision markets single-use spherical, toric and multifocal lenses under our clariti 1day brand and a single-use silicone hydrogel spherical lens under MyDay®.
We compete with clariti and MyDay, our single-use silicone hydrogel lenses, and our Proclear 1 Day products.
We also compete based on our customer and professional services.
For the IVF market, CooperSurgical is focused on the objectives of internal growth and growth through acquisitions.
In August 2015, CooperSurgical expanded its presence in the fertility market with the acquisition of Reprogenetics, a genetics laboratory specializing in preimplantation genetic screening (PGS) and preimplantation genetic diagnosis (PGD) used during the IVF process.
| • | Hysteroscopy is commonly used in the evaluation of abnormal uterine bleeding. |
| | |
| --- | --- |
CooperSurgical also competes in the fertility category of the women's healthcare market.
We have broad product offerings for fertility evaluations and IVF procedures by ob/gyns, reproductive endocrinologists and embryologists.
These include products for use by the ob/gyns in their offices for initial evaluations with office based hysteroscopy and first line treatments such as intrauterine insemination.
For use in fertility clinics our products include media, micro tools and lab equipment; and to improve IVF outcomes we offer testing services intended to increase implantation rates and decrease miscarriages.
CooperSurgical intends to leverage our relationship with fertility clinics to expand our presence in the fertility market against competitors in the media and microtools categories that include Vitrolife, Cook, Irvine Scientific and Life Global and competitors in genetic testing that include Genesis Genetics, Good Start Genetics and Igenomix.
Although many 510(k) pre-market notifications are cleared without clinical data, in some cases, the FDA requires significant clinical data to support substantial equivalence.
In reviewing a pre-market notification, the FDA may request additional information, including clinical data, which may significantly prolong the review process.
If the FDA disagrees with a
The FDA may approve a PMA application with post-approval conditions intended to ensure the safety and effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution and collection of long-term follow-up data from patients in the clinical study that supported approval.
Failure to comply with the conditions of approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval.
There can be no assurance that submission of an IDE will result in the ability to
commence clinical trials.
Additionally, after a trial begins, the FDA may place it on hold or terminate it if, among other reasons, it concludes that the clinical subjects are exposed to unacceptable health risks that outweigh the benefits of participation in the study.
During a study, we are required to comply with the FDA's IDE requirements for investigator selection, trial monitoring, reporting, record keeping and prohibitions on the promotion of investigational devices or making safety or efficacy claims for them.
We are also responsible for the appropriate labeling and distribution of investigational devices.
The time required to obtain approval in another country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ.
There is a trend towards harmonization of quality system standards among the European Union, United States, Canada and various other industrialized countries.
On October 31, 2015, Cooper had approximately 10,200 employees.
We also believe that the manufacturing processes acquired in connection with the Sauflon acquisition will be of value to us as these new platforms and processes may add greater flexibility and reduce time to market of our combined product offerings.
CooperVision has also launched two-week silicone hydrogel spherical and toric lens products under our Avaira® brand.
In fiscal 2013, we launched MyDayTM, our single-use spherical silicone hydrogel lens, in Europe.
To meet this anticipated demand, we plan to launch MyDay in more geographical regions, such as the United States during fiscal 2015, and to continue the implementation of capital projects to invest in increased single-use manufacturing capacity.
Consistent with this strategy, on August 6, 2014, we completed the acquisition of Sauflon Pharmaceuticals Limited (Sauflon), a privately-held European manufacturer and distributor of soft contact lenses and aftercare solutions.
Clariti lenses received United States FDA clearance in August 2013.
Sauflon is headquartered in the United Kingdom and has a global presence with manufacturing facilities in the United Kingdom and Hungary.
The Sauflon acquisition is intended to accelerate the growth of sales of our single-use products by enabling a multi-tier, single-use strategy with a full suite of hydrogel and silicone hydrogel product offerings in the major product categories of sphere, toric and multifocal lenses.
This acquisition is also intended to provide for an enhanced relationship with key European retailers and opportunities for operational synergies.
In addition, CooperVision lenses compete based on providing superior comfort through the use of lens edge technology.
CooperVision lenses have a round to partial round edge which we believe increases comfort.
CooperVision's primary competitors control the majority of the silicone hydrogel segment of the market.
In July 2012, CooperSurgical acquired Origio to form a combined medical device company that develops, manufactures and distributes highly specialized products that target IVF treatment with a goal to make fertility treatment safer, more efficient and convenient.
advantages of our products.
Most of these employees are in CooperVision.
Research and development expenditures represented 4 percent of net sales in fiscal 2012 - 2014.
As a practical matter, clearance can take significantly longer.
significant regulatory fines or penalties.
serious injury if it were to recur.
Even if regulatory approval or clearance of a medical device is granted, the FDA may impose limitations or restrictions on the uses and indications for which the device may be labeled and promoted.
Medical devices may be marketed only for the uses and indications for which they are cleared or approved.
FDA regulations prohibit a manufacturer from promoting a device for an unapproved or “off-label” use.
Failure to comply with this prohibition on “off-label” promotion can result in enforcement action by the FDA, including, among other things, warning letters, fines, injunctions, consent decrees and civil or criminal penalties.
The worldwide Medical Device regulations are increasing, with many countries becoming regulated for the first time.
For example, Hong Kong and Singapore are now regulated and following the Global Harmonization Task Force model for regulating medical devices.
These emerging regulated countries require the same rigorous safety data compiled in pre-clinical and clinical studies for the rest of the world.
Administration health programs and TRICARE.
On October 31, 2014, Cooper had about 9,460 employees, including 1,426 employees of Sauflon, acquired in August 2014.
An excerpt. Shown here: 40 of 75 rewritten, all 27 added and all 28 removed. The counts are complete. For every sentence, read Item 1. Business. in the FY2015 filing and the FY2014 filing.
Item 3. Legal Proceedings.
3 rewritten, 9 added, 1 removed, 3 unchanged
On or about November 11, 2014, Johnson & Johnson Vision Care (JJVC) filed an action in the district court of Dusseldorf, Germany, against CooperVision GmbH and CooperVision, Inc. (collectively [removed: “CooperVision”)] [added: “CooperVision” or “we”)] for patent infringement.
In the action, JJVC [removed: alleges] [added: alleged] that certain CooperVision products infringe JJVC’s European Patent No. EP 1 754 728 B1, and [removed: is] [added: was] seeking damages and to enjoin these products from selling in Germany.
[removed: CooperVision is] [added: We were] challenging the validity of the patent before the European Patent Office.
In July 2015, CooperVision made a one-time lump sum payment to JJVC of $17.0 million to settle our existing patent disputes.
As a result of the settlement, we withdrew our opposition to the JJVC patent filed before the European Patent Office, and JJVC withdrew its complaint of infringement pending before the district court of Dusseldorf, Germany.
The settlement included worldwide, non-exclusive, perpetual and royalty-free cross-licenses between the parties to certain patents including the JJVC patent referenced above.
The settlement also included reciprocal covenants not to sue on those patents which were not licensed with respect to each party’s current, core commercialized product offerings, including all silicone hydrogel lenses.
Neither party admitted any liability as part of the settlement.
Since March 2015, over 50 putative class action complaints were filed by contact lens consumers alleging that contact lens manufacturers, in conjunction with their respective Unilateral Pricing Policy (UPP), conspired to reach agreements between each other and certain distributors and retailers regarding the prices at which certain contact lenses could be sold to consumers.
The plaintiffs are seeking damages against CooperVision, Inc., other contact lens manufacturers, distributors and retailers, in various courts around the United States.
In June 2015, all of the class action cases were consolidated and transferred to the United States District Court for the Middle District of Florida.
CooperVision denies the allegations and intends to defend the actions vigorously.
CooperVision denies JJVC’s allegations of infringement and intends to defend the action vigorously and to continue its challenge to the patent before the European Patent Office.
Cover and table of contents
30 rewritten, 2 added, 1 removed, 127 unchanged
10-K 1 [removed: coo_20141031-10k.htm] [added: coo_20151031-10k.htm] 10-K
FOR THE FISCAL YEAR ENDED OCTOBER 31, [removed: 2014][added: 2015]
On November 30, [removed: 2014,] [added: 2015,] there were [removed: 47,842,980] [added: 47,948,696] shares of the registrant's common stock held by non-affiliates with aggregate market value of [removed: $6.3] [added: $8.6] billion on April 30, [removed: 2014,] [added: 2015,] the last day of the registrant's most recently completed fiscal second quarter.
Number of shares outstanding of the registrant's common stock, as of November 30, [removed: 2014: 48,158,484][added: 2015: 48,274,926]
| Portions of the Proxy Statement for the Annual Meeting of Stockholders scheduled to be held in March [removed: 2015] [added: 2016] | | Part III |
| Item 1. | Business | [removed: [5](#s3B80977DA3348008C4D265D1E6624FEC)] [added: [5](#sE2582589C965FE65B73EAE416C86F0D9)] |
| Item 1A. | Risk Factors | [removed: [17](#s955992BFEDCA1E73E8D265D1E6951742)] [added: [17](#sAFCC9E87D747465F9849AE416CB77E46)] |
| Item 1B. | Unresolved Staff Comments | [removed: [32](#sC56B5EE2D654E734A63065D1E6B9D9BF)] [added: [32](#sE7A6A851B76B24FBD542AE416CD94C94)] |
| Item 2. | Properties | [removed: [33](#s61831BBBEFCA1F4D01A565D1E6EB6F45)] [added: [33](#s9DA5E533021034F11750AE416D0AF95E)] |
| Item 3. | Legal Proceedings | [removed: [34](#sA31738AF0B39B753CA9065D1E70AB96B)] [added: [34](#s79D8909610BD53A7F5EAAE416D2DFE78)] |
| Item 5. | Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | [removed: [35](#s069E74D43EEEAB11F9B065D1E78FF6DA)] [added: [35](#s1C56433A79047A77B028AE416D804D3D)] |
| Item 6. | Selected Financial Data | [removed: [39](#s5B3EB1BAC06ADABED2E165D1D47ABA6A)] [added: [39](#s98D089BAFFC7C8DFE84CAE4160B16A23)] |
| Item 7. | Management's Discussion and Analysis of Financial Condition and Results of Operations | [removed: [40](#s3FB7B6D07755C7A2492D65D1E835B6BA)] [added: [40](#sE60491335BAF1B8D667CAE416E262827)] |
| Item 7A. | Quantitative and Qualitative Disclosure about Market Risk | [removed: [61](#s7FA3A56102427C37112565D1D62713FF)] [added: [63](#s89B03A02D1436C59A16AAE416033E99D)] |
| Item 8. | Financial Statements and Supplementary Data | [removed: [63](#s439C726AC527EE04962865D1E92FFC5C)] [added: [65](#s7AAD4D9881B7747E93EEAE416F2119CF)] |
| Item 9. | Changes In and Disagreements With Accountants on Accounting and Financial Disclosure | [removed: [109](#s8A7A9EBCE5A6BE272F0965D1EDC144A3)] [added: [112](#sFC1CE28CD559E3E5186DAE41745B9D0D)] |
| Item 9A. | Controls and Procedures | [removed: [109](#s4FEC33371D4775A92CD165D1EDDFFBEA)] [added: [112](#sAE007BCA9F9B6BD15988AE4174691A98)] |
| Item 9B. | Other Information | [removed: [110](#sBD1238CB8B3EFF0F369065D1EE106AA7)] [added: [113](#s5504E80A81F0BDC42BE1AE4174882F8A)] |
| Item 10. | Directors, Executive Officers and Corporate Governance | [removed: [111](#sC8B52A323BCB7F00837865D1EE658560)] [added: [114](#s10DF689674A9D589186DAE4174DAB6A6)] |
| Item 11. | Executive Compensation | [removed: [111](#sBE0DDE9A70A4EB50E3D365D1EE89AE96)] [added: [114](#s2AC4576E1C050746D140AE4174FD9427)] |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | [removed: [111](#s7527332C71605836D7C465D1EEBB07B3)] [added: [114](#s82BBBF7234058A7ECB5FAE41752F9FA7)] |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | [removed: [111](#s8B9A11F8C6E0473155A865D1EED83CAA)] [added: [114](#s6FA63D3019AD1BF1408BAE41755085AF)] |
| Item 14. | Principal Accounting Fees and Services | [removed: [111](#s522A306854FCE205FBCD65D1EF0B88DA)] [added: [114](#s2253B0AF70D97BAA8362AE4175863F1E)] |
| Item 15. | Exhibits and Financial Statement Schedules | [removed: [112](#sDEFBDEECBC8B169F3E0B65D1EF5F0DDE)] [added: [115](#s359F173A1E0E6EC14B32AE4175D4CCF0)] |
| • | Adverse changes in [added: the] global or regional general business, political and economic [removed: conditions due to the current global economic downturn,] [added: conditions,] including the impact of continuing uncertainty and instability of certain [removed: European Union] countries that could adversely affect our global markets. |
| • | Foreign currency exchange rate and interest rate fluctuations including the risk of fluctuations in the value of [removed: the yen, pound and euro] [added: foreign currencies] that would decrease our revenues and earnings. |
| • | A major disruption in the operations of our manufacturing, research and development or distribution facilities, due to technological problems, including any related to our information systems [removed: maintenance] [added: maintenance, enhancements] or [removed: enhancements,] [added: new system deployments and integrations, integration of acquisitions,] natural disasters or other causes. |
| • | Legal costs, insurance expenses, settlement costs and the risk of an adverse [removed: decision] [added: decision, prohibitive injunction] or settlement related to product liability, patent infringement or other litigation. |
| • | New U.S. and foreign government laws and regulations, and changes in existing laws, regulations and enforcement guidance, which affect the [added: contact lens industry, specifically, or the] medical device [removed: industry] and the healthcare [removed: industry] [added: industries] generally. |
| • | Other events described in our Securities and Exchange Commission filings, including the “Business” and “Risk Factors” sections in this Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 2014,] [added: 2015,] as such Risk Factors may be updated in quarterly filings. |
for the Fiscal Year Ended October 31, 2015
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 all statements regarding acquisitions including the acquired companies' financial position, market position, product development and business strategy, expected cost synergies, expecting 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 are forward-looking.
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.
Item 2. Properties.
18 rewritten, 0 added, 5 removed, 13 unchanged
The following is a summary of Cooper's principal facilities as of October 31, [removed: 2014.][added: 2015.]
[removed: Cooper] [added: We] generally [removed: leases its] [added: lease our] office and operations facilities but [removed: owns] [added: own] several manufacturing and research and development facilities, including 205,850 square feet in Hamble, United Kingdom, 49,500 square feet in Scottsville, New York, 63,787 square feet in Malov, Denmark, and 33,630 square feet in Stafford, Texas.
Our lease agreements expire at various dates through the year [removed: 2030.][added: 2045.]
[removed: The Company believes its] [added: We believe our] properties are suitable and adequate for [removed: its] [added: our] businesses.
| California | [removed: 136,369] [added: 112,109] | | | Executive offices; CooperVision research & development and administrative offices; CooperSurgical manufacturing and distribution |
| New York | [removed: 390,277] [added: 377,507] | | | CooperVision manufacturing, marketing, distribution and administrative offices |
| Connecticut | [removed: 210,837] [added: 291,237] | | | CooperSurgical manufacturing, marketing, distribution, research & development and administrative offices |
| Other [removed: United States] [added: Americas] | [removed: 42,200] [added: 69,295] | | | [removed: CooperSurgical manufacturing;] CooperVision marketing [added: and distribution; CooperSurgical manufacturing and marketing] |
| Puerto Rico | [removed: 333,124] [added: 510,792] | | | CooperVision manufacturing and distribution |
| Brazil | [removed: 17,545] [added: 16,576] | | | CooperVision marketing and distribution |
| United Kingdom | [removed: 675,553] [added: 666,157] | | | CooperVision manufacturing, marketing, distribution, research & development and administrative offices; CooperSurgical marketing |
| Belgium | [removed: 119,146] [added: 171,400] | | | CooperVision distribution |
| [removed: France] [added: Germany] | [removed: 12,388] [added: 27,949] | | | CooperVision marketing and distribution; CooperSurgical [added: manufacturing,] marketing [added: and distribution] |
| [removed: Germany] [added: Japan] | [removed: 75,887] [added: 73,932] | | | CooperVision [removed: marketing] [added: manufacturing, marketing, distribution] and [removed: distribution;] [added: administrative offices;] CooperSurgical [removed: manufacturing,] marketing [removed: and distribution] |
| Hungary | [removed: 158,300] [added: 150,302] | | | CooperVision manufacturing and marketing |
| [removed: Italy] [added: Other EMEA] | [removed: 31,197] [added: 141,474] | | | CooperVision [removed: marketing] and [removed: distribution;] CooperSurgical marketing [added: and distribution] |
| [removed: Netherlands] [added: Other Asia Pacific] | [removed: 33,865] [added: 65,117] | | | CooperVision and CooperSurgical marketing and distribution |
| [removed: Spain] [added: Australia] | [removed: 30,678] [added: 29,952] | | | CooperVision [removed: marketing] [added: manufacturing, marketing, distribution] and [removed: distribution;] [added: administrative offices;] CooperSurgical marketing |
We also own Sauflon's corporate headquarters in Twickenham, United Kingdon, at 7,916 square feet.
| South Africa | 13,250 | | | CooperVision marketing and distribution |
| Japan | 74,684 | | | CooperVision manufacturing, marketing, distribution and administrative offices; CooperSurgical marketing |
| Australia | 33,952 | | | CooperVision manufacturing, marketing, distribution and administrative offices |
| Other Asia Pacific | 55,526 | | | CooperVision and CooperSurgical marketing and distribution |
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
18 rewritten, 18 added, 17 removed, 36 unchanged
Cooper's common stock, par value $0.10 per share, is traded on the New York Stock Exchange under the symbol “COO.” In the table that follows, we indicate the high and low selling prices of our common stock for each three-month period of [removed: 2014] [added: 2015] and [removed: 2013:][added: 2014:]
| January 31 | $ | [removed: 135.00] [added: 171.54] | | | $ | [removed: 118.58] [added: 154.21] | | | $ | [removed: 102.47] [added: 135.00] | | | $ | [removed: 88.80] [added: 118.58] | |
| April 30 | $ | [removed: 145.34] [added: 190.00] | | | $ | [removed: 116.95] [added: 154.80] | | | $ | [removed: 110.85] [added: 145.34] | | | $ | [removed: 100.24] [added: 116.95] | |
| July 31 | $ | [removed: 163.24] [added: 186.37] | | | $ | [removed: 127.02] [added: 170.50] | | | $ | [removed: 129.06] [added: 163.24] | | | $ | [removed: 105.71] [added: 127.02] | |
| October 31 | $ | [removed: 166.52] [added: 179.75] | | | $ | [removed: 143.62] [added: 136.75] | | | $ | [removed: 135.41] [added: 166.52] | | | $ | [removed: 124.00] [added: 143.62] | |
At November 30, [removed: 2014,] [added: 2015,] there were [removed: 489] [added: 454] common stockholders of record.
In dollar terms, we paid cash for dividends of about $2.9 million in fiscal [removed: 2014] [added: 2015] and $2.9 million in fiscal [removed: 2013.][added: 2014.]
The following graph compares the cumulative total return on [removed: the Company's] [added: Cooper] common stock with the cumulative total return of the Standard & Poor's [removed: Smallcap 600 Stock Index] [added: Midcap 400] and the Standard & Poor's Health Care Equipment Index for the five-year period ended October 31, [removed: 2014.][added: 2015.]
The graph assumes that the value of the investment in [removed: the Company] [added: Cooper] and in each index was $100 on October 31, [removed: 2009,] [added: 2010,] and assumes that all dividends were reinvested.
Among The Cooper Companies, Inc., the S&P Smallcap 600 [removed: Index][added: Index,]
[added: the S&P Midcap 400 Index] and the S&P Health Care Equipment Index
[removed: ][added: ]
*$100 invested on [removed: 10/31/09] [added: 10/31/10] in stock or index, including reinvestment of dividends.
During the three-month period ended October 31, [removed: 2014,] [added: 2015,] we repurchased shares of our common stock as follows:
At October 31, [removed: 2014,] [added: 2015,] the remaining repurchase authorization under the 2012 Share Repurchase Program was approximately [removed: $185.7] [added: $118.4] million.
(1) The amount of total securities to be issued under [removed: the Company's] [added: Company] equity plans shown in Column A includes [removed: 598,667] [added: 516,206] Restricted Stock Units granted pursuant to the Company's equity plans.
These awards allow for the distribution of shares to the grant recipient upon the completion of time-based holding [removed: periods and do not have an associated exercise price.][added: periods.]
(2) Includes information with respect to the Second Amended and Restated 2007 Long-Term Incentive Plan for Employees of [removed: The] [added: the] Cooper Companies, Inc. [removed: (2007 Plan),] [added: ("2007 Plan"),] which was approved by stockholders on March 16, 2011, and provides for the issuance of up to 5,230,000 shares of [removed: common stock,] [added: Common Stock,] and the Second Amended and Restated 2006 Long Term Incentive Plan for Non-Employee Directors of [removed: The] [added: the] Cooper Companies, Inc. (the [removed: Directors’ Plan),] [added: “Directors’ Plan”),] which was approved by stockholders on March 16, [removed: 2011,] [added: 2011] and provides for the issuance of up to 950,000 shares of [removed: common stock.][added: Common Stock.]
| | 2015 | | | | | | | | 2014 | | | | | | |
The graph also includes the cumulative total return of the Standard & Poor's Smallcap 600 Stock Index as we presented this information in prior years but now consider the comparison to the Standard & Poor's Midcap 400 as a more appropriate comparison to our size and position in the market.
Copyright© 2015 S&P, a division of McGraw-Hill Financial.
All rights reserved.
| | 10/10 | | | | 10/11 | | | | 10/12 | | | | 10/13 | | | | 10/14 | | | | 10/15 | | |
| The Cooper Companies, Inc. | $ | 100.00 | | | $ | 140.58 | | | $ | 194.86 | | | $ | 262.47 | | | $ | 333.08 | | | $ | 309.74 | |
| S&P Smallcap 600 | $ | 100.00 | | | $ | 110.54 | | | $ | 125.57 | | | $ | 174.65 | | | $ | 190.88 | | | $ | 196.32 | |
| S&P Midcap 400 | $ | 100.00 | | | $ | 108.55 | | | $ | 121.69 | | | $ | 162.44 | | | $ | 181.37 | | | $ | 187.57 | |
| S&P Health Care Equipment | $ | 100.00 | | | $ | 106.59 | | | $ | 121.70 | | | $ | 152.79 | | | $ | 190.35 | | | $ | 207.56 | |
| 8/1/15 – 8/31/15 | | — | | | $ | — | | | — | | | $ | 169,700,000 | |
| 9/1/15 – 9/30/15 | | — | | | $ | — | | | — | | | $ | 169,700,000 | |
| 10/1/15 – 10/31/15 | | 367,539 | | | $ | 139.60 | | | 367,539 | | | $ | 118,400,000 | |
| Total | | 367,539 | | | | | | | 367,539 | | | | | |
| Equity compensation plans approved by shareholders(2) | 1,866,494 | | $79.85 | | 943,522 |
| Total | 1,866,494 | | $79.85 | | 943,522 |
The total also includes 29,850 shares to be issued pursuant to Performance Share Awards which previously vested and receipt of shares was deferred for a specified period of time and 229,907 shares representing the maximum number of share that may be issued subject to Performance Share Awards without a defined payout.
Restricted Stock Units and Performance Share Awards do not have an associated exercise price.
As of October 31, 2015, 757,747 shares remained available under the 2007 Plan and 185,775 shares remained available under the 2006 Directors’ Plan.
| | 2014 | | | | | | | | 2013 | | | | | | |
Copyright© 2014 S&P, a division of The McGraw-Hill Companies Inc. All rights reserved.
| | 10/09 | | | | 10/10 | | | | 10/11 | | | | 10/12 | | | | 10/13 | | | | 10/14 | | |
| The Cooper Companies, Inc. | $ | 100.00 | | | $ | 176.43 | | | $ | 248.02 | | | $ | 343.79 | | | $ | 463.06 | | | $ | 587.64 | |
| S&P Smallcap 600 | $ | 100.00 | | | $ | 126.27 | | | $ | 139.58 | | | $ | 158.56 | | | $ | 220.53 | | | $ | 241.03 | |
| S&P Health Care Equipment | $ | 100.00 | | | $ | 104.00 | | | $ | 110.86 | | | $ | 126.57 | | | $ | 158.91 | | | $ | 197.97 | |
| 8/1/14 – 8/31/14 | | — | | | $ | — | | | — | | | $ | 211,500,000 | |
| 9/1/14 – 9/30/14 | | — | | | $ | — | | | — | | | $ | 211,500,000 | |
| 10/1/14 – 10/31/14 | | 175,786 | | | $ | 146.64 | | | 175,786 | | | $ | 185,700,000 | |
| Total | | 175,786 | | | | | | | 175,786 | | | | | |
| Equity compensation plans approved by shareholders(2) | 1,922,603 | | $63.32 | | 1,696,162 |
| Total | 1,922,603 | | $63.32 | | 1,696,162 |
__________
Amounts in Column A do not reflect performance share awards without a final payout.
As of October 31, 2014, up to 1,507,591 shares of common stock may be issued pursuant to the 2007 Plan and 334,212 shares of common stock may be issued pursuant to the 2006 Directors’ Plan.
Also includes information with respect to the 1996 Long Term Incentive Plan for Non-Employee Directors (1996 Directors' Plan) and the Second Amended and Restated 2001 Long Term Incentive Plan (2001 Plan) of The Cooper Companies, Inc., which were originally approved by stockholders on March 21, 1996 and March 28, 2001.
The 1996 Directors' Plan and 2001 Plan have expired by their terms, but up to 80,800 shares of common stock may be issued pursuant to awards that remain outstanding under these plans.
Item 6. Selected Financial Data.
19 rewritten, 1 added, 0 removed, 11 unchanged
| Years Ended October 31, (In thousands, except per share amounts) | [removed: 2014] [added: 2015] | | | | [removed: 2013] [added: 2014] | | | | [removed: 2012] [added: 2013] | | | | [removed: 2011] [added: 2012] | | | | [removed: 2010] [added: 2011] | | |
| Net sales | $ | [removed: 1,717,776] [added: 1,797,060] | | | $ | [removed: 1,587,725] [added: 1,717,776] | | | $ | [removed: 1,445,136] [added: 1,587,725] | | | $ | [removed: 1,330,835] [added: 1,445,136] | | | $ | [removed: 1,158,517] [added: 1,330,835] | |
| Gross profit | $ | [removed: 1,091,570] [added: 1,070,262] | | | $ | [removed: 1,026,808] [added: 1,091,570] | | | $ | [removed: 924,010] [added: 1,026,808] | | | $ | [removed: 804,804] [added: 924,010] | | | $ | [removed: 676,723] [added: 804,804] | |
| Income before income taxes | $ | [removed: 296,534] [added: 215,485] | | | $ | [removed: 312,271] [added: 296,534] | | | $ | [removed: 275,452] [added: 312,271] | | | $ | [removed: 192,764] [added: 275,452] | | | $ | [removed: 124,426] [added: 192,764] | |
| Net income attributable to Cooper stockholders | $ | [removed: 269,856] [added: 203,523] | | | $ | [removed: 296,151] [added: 269,856] | | | $ | [removed: 248,339] [added: 296,151] | | | $ | [removed: 175,430] [added: 248,339] | | | $ | [removed: 112,803] [added: 175,430] | |
| Diluted earnings per share attributable to Cooper stockholders | $ | [removed: 5.51] [added: 4.14] | | | $ | [removed: 5.96] [added: 5.51] | | | $ | [removed: 5.05] [added: 5.96] | | | $ | [removed: 3.63] [added: 5.05] | | | $ | [removed: 2.43] [added: 3.63] | |
| Number of shares used to compute diluted earnings per share | [removed: 48,960] [added: 49,179] | | | | [removed: 49,685] [added: 48,960] | | | | [removed: 49,152] [added: 49,685] | | | | [removed: 48,309] [added: 49,152] | | | | [removed: 46,505] [added: 48,309] | | |
| Current assets | $ | [removed: 791,617] [added: 841,818] | | | $ | [removed: 747,241] [added: 791,617] | | | $ | [removed: 657,860] [added: 747,241] | | | $ | [removed: 540,347] [added: 657,860] | | | $ | [removed: 491,340] [added: 540,347] | |
| Property, plant and equipment, net | [removed: 937,325] [added: 967,097] | | | | [removed: 739,867] [added: 937,325] | | | | [removed: 640,255] [added: 739,867] | | | | [removed: 609,205] [added: 640,255] | | | | [removed: 593,887] [added: 609,205] | | |
| Goodwill | [removed: 2,220,921] [added: 2,197,077] | | | | [removed: 1,387,611] [added: 2,220,921] | | | | [removed: 1,370,247] [added: 1,387,611] | | | | [removed: 1,276,567] [added: 1,370,247] | | | | [removed: 1,261,976] [added: 1,276,567] | | |
| Other intangible assets, net | [removed: 453,605] [added: 411,090] | | | | [removed: 198,769] [added: 453,605] | | | | [removed: 214,783] [added: 198,769] | | | | [removed: 128,341] [added: 214,783] | | | | [removed: 114,177] [added: 128,341] | | |
| Other assets | [removed: 54,872] [added: 43,528] | | | | [removed: 63,773] [added: 54,872] | | | | [removed: 58,239] [added: 63,773] | | | | [removed: 70,058] [added: 58,239] | | | | [removed: 63,638] [added: 70,058] | | |
| | $ | [removed: 4,458,340] [added: 4,460,610] | | | $ | [removed: 3,137,261] [added: 4,458,340] | | | $ | [removed: 2,941,384] [added: 3,137,261] | | | $ | [removed: 2,624,518] [added: 2,941,384] | | | $ | [removed: 2,525,018] [added: 2,624,518] | |
| Short-term debt | $ | [removed: 101,518] [added: 244,193] | | | $ | [removed: 42,987] [added: 101,518] | | | $ | [removed: 25,284] [added: 42,987] | | | $ | [removed: 52,979] [added: 25,284] | | | $ | [removed: 19,159] [added: 52,979] | |
| Other current liabilities | [removed: 340,664] [added: 324,979] | | | | [removed: 278,266] [added: 340,664] | | | | [removed: 237,268] [added: 278,266] | | | | [removed: 214,227] [added: 237,268] | | | | [removed: 180,361] [added: 214,227] | | |
| Long-term debt | [removed: 1,280,833] [added: 1,105,764] | | | | [removed: 301,670] [added: 1,280,833] | | | | [removed: 348,422] [added: 301,670] | | | | [removed: 327,453] [added: 348,422] | | | | [removed: 591,977] [added: 327,453] | | |
| Other liabilities | [removed: 146,885] [added: 111,770] | | | | [removed: 90,844] [added: 146,885] | | | | [removed: 117,252] [added: 90,844] | | | | [removed: 92,371] [added: 117,252] | | | | [removed: 66,745] [added: 92,371] | | |
| Total liabilities | [removed: 1,869,900] [added: 1,786,706] | | | | [removed: 713,767] [added: 1,869,900] | | | | [removed: 728,226] [added: 713,767] | | | | [removed: 687,030] [added: 728,226] | | | | [removed: 858,242] [added: 687,030] | | |
| Stockholders' equity | [removed: 2,588,440] [added: 2,673,904] | | | | [removed: 2,423,494] [added: 2,588,440] | | | | [removed: 2,213,158] [added: 2,423,494] | | | | [removed: 1,937,488] [added: 2,213,158] | | | | [removed: 1,666,776] [added: 1,937,488] | | |
| | $ | 4,460,610 | | | $ | 4,458,340 | | | $ | 3,137,261 | | | $ | 2,941,384 | | | $ | 2,624,518 | |
Item 8. Financial Statements and Supplementary Data.
382 rewritten, 234 added, 180 removed, 789 unchanged
We have audited the accompanying consolidated balance sheets of The Cooper Companies, Inc. and subsidiaries (the Company) as of October 31, [removed: 2014] [added: 2015] and [removed: 2013,] [added: 2014,] and 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, [removed: 2014.][added: 2015.]
We also have audited the Company’s internal control over financial reporting as of October 31, [removed: 2014,] [added: 2015,] based on criteria established in Internal Control - Integrated Framework [removed: (1992)] [added: (2013)] issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of [removed: the Company] [added: The Cooper Companies, Inc.] and subsidiaries as of October 31, [removed: 2014] [added: 2015] and [removed: 2013,] [added: 2014,] and the results of its operations and its cash flows for each of the years in the three-year period ended October 31, [removed: 2014,] [added: 2015,] 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, [removed: 2014,] [added: 2015,] based on criteria established in Internal Control - Integrated Framework [removed: (1992)] [added: (2013)] issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
| Years Ended October 31, (In thousands, except per share amounts) | [removed: 2014] [added: 2015] | | | | [removed: 2013] [added: 2014] | | | | [removed: 2012] [added: 2013] | | |
| Net sales | $ | [removed: 1,717,776] [added: 1,797,060] | | | $ | [removed: 1,587,725] [added: 1,717,776] | | | $ | [removed: 1,445,136] [added: 1,587,725] | |
| Cost of sales | [removed: 626,206] [added: 726,798] | | | | [removed: 560,917] [added: 626,206] | | | | [removed: 521,126] [added: 560,917] | | |
| Gross profit | [removed: 1,091,570] [added: 1,070,262] | | | | [removed: 1,026,808] [added: 1,091,570] | | | | [removed: 924,010] [added: 1,026,808] | | |
| Selling, general and administrative expense | [removed: 683,115] [added: 712,543] | | | | [removed: 610,735] [added: 683,115] | | | | [removed: 564,903] [added: 610,735] | | |
| Research and development expense | [removed: 66,259] [added: 69,589] | | | | [removed: 58,827] [added: 66,259] | | | | [removed: 51,730] [added: 58,827] | | |
| Amortization of intangibles | [removed: 35,710] [added: 51,459] | | | | [removed: 30,239] [added: 35,710] | | | | [removed: 23,979] [added: 30,239] | | |
| Loss on divestiture of Aime | — | | | | [removed: 21,062] [added: —] | | | | [removed: —] [added: 21,062] | | |
| Operating income | [removed: 306,486] [added: 236,671] | | | | [removed: 305,945] [added: 306,486] | | | | [removed: 283,398] [added: 305,945] | | |
| Interest expense | [removed: 7,965] [added: 18,103] | | | | [removed: 9,168] [added: 7,965] | | | | [removed: 11,771] [added: 9,168] | | |
| Gain on insurance proceeds | — | | | | [removed: 14,084] [added: —] | | | | [removed: 5,000] [added: 14,084] | | |
| Other expense (income), net | [removed: 1,987] [added: 3,083] | | | | [removed: (1,410] [added: 1,987] | | [removed: )] | | [removed: (229] [added: (1,410] | | ) |
| Income before income taxes | [removed: 296,534] [added: 215,485] | | | | [removed: 312,271] [added: 296,534] | | | | [removed: 275,452] [added: 312,271] | | |
| Provision for income taxes | [removed: 24,705] [added: 10,341] | | | | [removed: 15,365] [added: 24,705] | | | | [removed: 26,808] [added: 15,365] | | |
| Net income | [removed: 271,829] [added: 205,144] | | | | [removed: 296,906] [added: 271,829] | | | | [removed: 248,644] [added: 296,906] | | |
| [added: Less:] Income attributable to noncontrolling interests | [removed: 1,973] [added: 1,621] | | | | [removed: 755] [added: 1,973] | | | | [removed: 305] [added: 755] | | |
| Net income attributable to Cooper stockholders | $ | [removed: 269,856] [added: 203,523] | | | $ | [removed: 296,151] [added: 269,856] | | | $ | [removed: 248,339] [added: 296,151] | |
| Earnings per share attributable to Cooper stockholders - basic | $ | [removed: 5.61] [added: 4.20] | | | $ | [removed: 6.09] [added: 5.61] | | | $ | [removed: 5.18] [added: 6.09] | |
| Earnings per share attributable to Cooper stockholders - diluted | $ | [removed: 5.51] [added: 4.14] | | | $ | [removed: 5.96] [added: 5.51] | | | $ | [removed: 5.05] [added: 5.96] | |
| Basic | [removed: 48,061] [added: 48,452] | | | | [removed: 48,615] [added: 48,061] | | | | [removed: 47,913] [added: 48,615] | | |
| Diluted | [removed: 48,960] [added: 49,179] | | | | [removed: 49,685] [added: 48,960] | | | | [removed: 49,152] [added: 49,685] | | |
| Years Ended October 31, (In thousands) | [removed: 2014] [added: 2015] | | | | [removed: 2013] [added: 2014] | | | | [removed: 2012] [added: 2013] | | |
| Net income | $ | [removed: 271,829] [added: 205,144] | | | $ | [removed: 296,906] [added: 271,829] | | | $ | [removed: 248,644] [added: 296,906] | |
| Foreign currency translation adjustment | [removed: (87,763] [added: (79,424] | | ) | | [removed: 2,607] [added: (87,763] | | [added: )] | | [removed: (4,658] [added: 2,607] | | [removed: )] |
| Change in value of derivative instruments, net of tax provision of [removed: $630, $857] [added: $30, $630] and [removed: $289,] [added: $857,] respectively | [removed: 986] [added: 47] | | | | [removed: 1,341] [added: 986] | | | | [removed: 452] [added: 1,341] | | |
| Change in minimum pension liability, net of tax (benefit) provision of [removed: $(2,348), $7,399] [added: $(3,908), $(2,348)] and [removed: $(5,764),] [added: $7,399,] respectively | [removed: (3,643] [added: (6,084] | | ) | | [removed: 11,601] [added: (3,643] | | [added: )] | | [removed: (8,986] [added: 11,601] | | [removed: )] |
| [removed: Unrealized] [added: Reclassification of realized] gain on marketable [removed: securities,] [added: securities to] net [added: income, net] of tax provision of [removed: $20] [added: $27] in fiscal [removed: 2012] [added: 2013] | — | | | | — | | | | [removed: 41] [added: (50] | | [added: )] |
| Other comprehensive (loss) income | [removed: (90,420] [added: (85,461] | | ) | | [removed: 15,499] [added: (90,420] | | [added: )] | | [removed: (13,151] [added: 15,499] | | [removed: )] |
| Comprehensive income | [removed: 181,409] [added: 119,683] | | | | [removed: 312,405] [added: 181,409] | | | | [removed: 235,493] [added: 312,405] | | |
| Comprehensive (income) loss attributable to noncontrolling interests | [removed: (733] [added: (533] | | ) | | [removed: 717] [added: (733] | | [added: )] | | [removed: (285] [added: 717] | | [removed: )] |
| Comprehensive income attributable to Cooper stockholders | $ | [removed: 180,676] [added: 119,150] | | | $ | [removed: 313,122] [added: 180,676] | | | $ | [removed: 235,208] [added: 313,122] | |
| October 31, (In thousands) | [removed: 2014] [added: 2015] | | | | [removed: 2013] [added: 2014] | | |
| Cash and cash equivalents | $ | [removed: 25,222] [added: 16,426] | | | $ | [removed: 77,393] [added: 25,222] | |
| Trade accounts receivable, net of allowance for doubtful accounts of [removed: $6,025] [added: $5,956] at October 31, [removed: 2014] [added: 2015] and [removed: $5,261] [added: $6,025] at October 31, [removed: 2013] [added: 2014] | [removed: 276,280] [added: 282,918] | | | | [removed: 229,537] [added: 276,280] | | |
| Inventories | [removed: 381,474] [added: 419,692] | | | | [removed: 338,917] [added: 381,474] | | |
| Deferred tax assets | [removed: 40,224] [added: 41,731] | | | | [removed: 41,179] [added: 40,224] | | |
| | 967,097 | | | | 937,325 | | |
| | $ | 4,460,610 | | | $ | 4,458,340 | |
| | $ | 4,460,610 | | | $ | 4,458,340 | |
| Issuance of common stock for stock plans | 593 | | | 59 | | | | (18 | ) | | (2 | | ) | | (6,690 | | ) | | — | | | | — | | | | 1,817 | | | | — | | | | (4,816 | | ) |
| Purchase of shares from noncontrolling interests | — | | | — | | | | — | | | — | | | | 3,448 | | | | — | | | | — | | | | — | | | | (11,518 | | ) | | (8,070 | | ) |
| Distributions to noncontrolling interests | — | | | — | | | | — | | | — | | | | — | | | | — | | | | — | | | | — | | | | (714 | | ) | | (714 | | ) |
| Balance at October 31, 2015 | 48,268 | | | $ | 4,827 | | | 3,290 | | | $ | 329 | | | $ | 1,434,705 | | | $ | (191,643 | ) | | $ | 1,779,440 | | | $ | (360,149 | ) | | $ | 6,395 | | | $ | 2,673,904 | |
| Years Ended October 31, (In thousands) | 2015 | | | | 2014 | | | | 2013 | | |
| Net income | $ | 205,144 | | | $ | 271,829 | | | $ | 296,906 | |
| Loss on divestiture of Aime | — | | | | — | | | | 21,062 | | |
| Payment of loan notes issued for Sauflon acquisition | (51,208 | | ) | | — | | | | — | | |
| Net (payments) proceeds related to share-based compensation awards | (4,816 | | ) | | 8,585 | | | | 19,287 | | |
In April 2015, the FASB issued Accounting Standards Update (ASU) 2015-03, Interest - Imputation of Interest (Subtopic 835-30) Simplifying the Presentation of Debt Issuance Costs.
The amendments in this update require that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts.
Accounting Pronouncements Recently Adopted
The adoption of ASU 2013-11 did not have a significant impact on our consolidated financial statements.
Certain prior year amounts have been reclassified to conform to the current year's presentation.
We believe that the counterparties with which we
We had no outstanding interest rate swaps at October 31, 2015.
At October 31, 2015, we had no outstanding interest rate swaps.
| October 31, (In millions) | 2015 | | | | 2014 | | |
| Raw materials | $ | 80.9 | | | $ | 76.9 | |
| Work-in-process | 14.5 | | | | 14.3 | | |
| Finished goods | 324.3 | | | | 290.3 | | |
| | $ | 419.7 | | | $ | 381.5 | |
| October 31, (In millions) | 2015 | | | | 2014 | | |
| Buildings and improvements | 226.1 | | | | 205.5 | | |
| Machinery and equipment | 1,085.1 | | | | 980.8 | | |
| Construction in progress | 319.7 | | | | 319.0 | | |
| Less: Accumulated depreciation | 683.6 | | | | 588.6 | | |
| | $ | 967.1 | | | $ | 937.3 | |
The loan notes were denominated in British pounds and redeemed and paid in our fiscal second quarter of 2015.
| Goodwill | | $ | 856.2 | |
acquired, interest expense associated with the financing obtained by Cooper in connection with the acquisition, and the elimination of incurred acquisition-related costs.
The intangible assets include $82.1 million for customer relationships with
We estimate the total restructuring costs under this plan to be $112.0 million.
The $8.0 million increase over our fiscal third quarter estimate relates to additional product rationalization and related equipment disposals and accelerated depreciation, primarily related to our hydrogel contact lenses, based on our review of products, materials and manufacturing processes of Sauflon.
We expect to be substantially complete with activities related to operating expenses in our fiscal first quarter of 2016, and to incur costs related to manufacturing activities through the end of fiscal 2016.
These estimated costs include approximately $89.0 million associated with assets, including product rationalization and related equipment disposals and accelerated depreciation, about $19.0 million associated with employee termination costs and about $4.0 million associated with facility lease termination costs.
In fiscal 2015, we recorded in cost of sales $57.7 million of expense, arising from production-related asset disposals and accelerated depreciation on equipment, primarily related to our hydrogel lenses, based on our review of products, materials and manufacturing processes of Sauflon.
The Company acquired Sauflon Pharmaceuticals Limited on August 6, 2014, and management excluded from its assessment of the effectiveness of the Company’s internal control over financial reporting as of October 31, 2014, Sauflon Pharmaceuticals Limited’s internal control over financial reporting which represented 3% and 30%, respectively, of total net sales and total assets of the related consolidated financial statement amounts of the Company as of and for the year ended October 31, 2014.
Our audit of internal control over financial reporting of the Company also excluded an evaluation of the internal control over financial reporting of Sauflon Pharmaceuticals Limited.
December 19, 2014
| Loss on extinguishment of debt | — | | | | — | | | | 1,404 | | |
| Reclassification of realized gain on marketable securities to net income, net of tax of $27 in fiscal 2013 | — | | | | (50 | | ) | | — | | |
| | 937,325 | | | | 739,867 | | |
| | $ | 4,458,340 | | | $ | 3,137,261 | |
| Balance at October 31, 2011 | 47,846 | | | $ | 4,785 | | | 169 | | | $ | 17 | | | $ | 1,180,250 | | | $ | (18,110 | ) | | $ | 773,136 | | | $ | (2,590 | ) | | $ | — | | | $ | 1,937,488 | |
| Issuance of common stock for stock plans | 1,578 | | | 157 | | | | (146 | ) | | (14 | | ) | | 45,923 | | | | — | | | | — | | | | 8,987 | | | | — | | | | 55,053 | | |
| Accrued litigation settlements | — | | | | — | | | | 1,724 | | |
| Loss on extinguishment of debt and other | — | | | | — | | | | 867 | | |
| Proceeds from issuance of common stock for employee stock plans | 8,585 | | | | 19,287 | | | | 55,053 | | |
initially applying the update recognized at the date of the initial application along with additional disclosures.
swaps.
The one outstanding swap has been and is expected to remain highly effective for the life of the swap.
The $0.1 million fair value of the outstanding swap is recorded in our Consolidated Balance Sheet and additional liabilities of $0.1 million and $0.3 million as of October 31, 2014 and 2013, respectively, were recorded and attributable to accrued interest.
We expect to reclassify the remaining $0.1 million from other comprehensive income to interest expense in our Consolidated Statements of Income over the next 12 months.
We received payments
| Raw materials | $ | 76,870 | | | $ | 79,331 | |
| Work-in-process | 14,344 | | | | 10,515 | | |
| Finished goods | 290,260 | | | | 249,071 | | |
| | $ | 381,474 | | | $ | 338,917 | |
See Note 2 for additional information on the increase in finished goods inventory related to the acquisition of Sauflon.
| Buildings and improvements | 205,490 | | | | 184,616 | | |
| Machinery and equipment | 980,755 | | | | 831,356 | | |
| Construction in progress | 319,120 | | | | 208,322 | | |
| Less: Accumulated depreciation | 588,592 | | | | 500,709 | | |
| | $ | 937,325 | | | $ | 739,867 | |
The loan notes are denominated in British pounds and are classified as short-term debt.
| Goodwill | | $ | 857.1 | |
The amounts of revenue and net loss of Sauflon included in our Consolidated Statement of Income from August 1, 2014 to October 31, 2014, were $49.7 million and $2.0 million, respectively.
We incurred $20.0 million of acquisition costs that were expensed as operating expenses in fiscal 2014.
The fair value of assets acquired and liabilities assumed was based upon preliminary valuations, and our estimates and assumptions are subject to change as the valuations are finalized, within the measurement period not to exceed 12 months from the acquisition date.
We are currently in the process of verifying data and finalizing information related to the Sauflon valuation and recording of inventory, liabilities, commitments and contingencies, including potential legal matters, income taxes and the corresponding effect on goodwill.
goodwill of $12.4 million.
We expect these activities to be completed by our fiscal first quarter of 2016.
| Balance as of October 31, 2012 | $ | 1,044,054 | | | $ | 326,193 | | | $ | 1,370,247 | |
| Translation | 1,061 | | | | 1,923 | | | | 2,984 | | |
| Balance as of October 31, 2013 | $ | 1,048,478 | | | $ | 339,133 | | | $ | 1,387,611 | |
| Net additions during the year ended October 31, 2014 | 857,146 | | | | 25,543 | | | | 882,689 | | |
An excerpt. Shown here: 40 of 382 rewritten, 40 of 234 added and 40 of 180 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data. in the FY2015 filing and the FY2014 filing.
Item 9A. Controls and Procedures.
5 rewritten, 0 added, 2 removed, 11 unchanged
The Company's Chief Executive Officer and Chief Financial Officer, based upon their evaluation as of October 31, [removed: 2014,] [added: 2015,] 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 assessed the effectiveness of the Company's internal control over financial reporting as of October 31, [removed: 2014,] [added: 2015,] based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control - Integrated Framework [removed: (1992).][added: (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, [removed: 2014.][added: 2015.]
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, [removed: 2014,] [added: 2015,] as stated in their report in Part II, Item 8 of this Annual Report on Form 10-K.
There has been no change in the Company's internal control over financial reporting during the Company's fiscal quarter ended October 31, [removed: 2014,] [added: 2015,] that has materially affected, or is reasonably likely to materially affect, the Company's internal control over financial reporting.
Management has excluded Sauflon Pharmaceuticals Limited from its assessment of internal control over financial reporting as of October 31, 2014, as permitted by the guidance issued by the Office of the Chief Accountant of the Securities and Exchange Commission.
Sauflon was acquired by the Company in a purchase business combination during the fiscal fourth quarter of 2014 and represented 3% and 30%, respectively, of total net sales and total assets of the related consolidated financial statement amounts as of and for the year ended October 31, 2014.
Item 10. Directors, Executive Officers and Corporate Governance.
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this item is incorporated by reference to the subheadings, “Proposal 1 - Election of Directors,” “Executive Officers of the Company,” “Ownership of the Company - Section 16(a) Beneficial Ownership Reporting Compliance,” “Corporate Governance - The Board of Directors,” “Corporate Governance - Ethics and Business Conduct Policy,” “Corporate Governance - Board Committees - The Audit Committee” and “Report of the Audit Committee” of the Company's Proxy Statement for the Annual Meeting of Stockholders scheduled to be held in March [removed: 2015] [added: 2016] (the [removed: “2015] [added: “2016] Proxy Statement”).
Item 11. Executive Compensation.
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this item is incorporated by reference to the subheadings “Report of the Organization and Compensation Committee,” “Compensation Discussion and Analysis,” “Executive Compensation Tables” and “Director Compensation” of the [removed: 2015] [added: 2016] Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
1 rewritten, 0 added, 0 removed, 2 unchanged
Additional information required by this item is incorporated by reference to the subheadings “Securities Held by Insiders” and “Principal Securityholders” of the “Ownership of the Company” section of the [removed: 2015] [added: 2016] Proxy Statement.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this item is incorporated by reference to the subheadings “Corporate Governance - Related Party Transactions,” “Proposal 1 - Election of Directors” and “Corporate Governance - The Board of Directors” of the [removed: 2015] [added: 2016] Proxy Statement.
Item 14. Principal Accounting Fees and Services.
1 rewritten, 0 added, 0 removed, 2 unchanged
The information required by this item is incorporated by reference to “Report of the Audit Committee” section of the [removed: 2015] [added: 2016] Proxy Statement.
Item 15. Exhibits and Financial Statement Schedules.
55 rewritten, 5 added, 25 removed, 188 unchanged
Statements of Income for the years ended October 31, [removed: 2014, 2013] [added: 2015, 2014] and [removed: 2012][added: 2013]
Statements of Comprehensive Income for the years ended October 31, [removed: 2014, 2013] [added: 2015, 2014] and [removed: 2012][added: 2013]
Balance Sheets as of October 31, [removed: 2014] [added: 2015] and [removed: 2013][added: 2014]
Statements of Stockholders' Equity for the years ended October 31, [removed: 2014, 2013] [added: 2015, 2014] and [removed: 2012][added: 2013]
Statements of Cash Flows for the years ended October 31, [removed: 2014, 2013] [added: 2015, 2014] and [removed: 2012][added: 2013]
Three Years Ended October 31, [removed: 2014][added: 2015]
| (In [removed: thousands)] [added: millions)] | Balance Beginning of Year | | | | Additions Charged to Costs and Expenses | | | | (Deductions) Recoveries/ Other (1) | | | | Balance at End of Year | | |
| (In [removed: thousands)] [added: millions)] | Balance Beginning of Year | | | | Additions (2) | | | | Reductions/ Charges (3) | | | | Balance at End of Year | | |
| Year Ended October 31, 2014 | $ | [removed: 968] [added: 1.0] | | | $ | [removed: 13,538] [added: 13.5] | | | $ | — | | | $ | [removed: 14,506] [added: 14.5] | |
| Year Ended October 31, 2013 | $ | [removed: 1,107] [added: 1.1] | | | $ | — | | | $ | [removed: (139] [added: (0.1] | ) | | $ | [removed: 968] [added: 1.0] | |
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 [removed: 19, 2014.][added: 18, 2015.]
| /s/ ROBERT S. WEISS | | President, Chief Executive Officer and Director | | December [removed: 19, 2014] [added: 18, 2015] |
| /s/ A. THOMAS BENDER | | Chairman of the Board | | December [removed: 19, 2014] [added: 18, 2015] |
| /s/ ALLAN E. RUBENSTEIN, M.D. | | Vice Chairman of the Board and Lead Director | | December [removed: 19, 2014] [added: 18, 2015] |
| /s/ GREG W. MATZ | | [added: Senior] Vice President, Chief Financial Officer and Chief Risk Officer | | December [removed: 19, 2014] [added: 18, 2015] |
| /s/ TINA MALONEY | | Vice President and Corporate Controller | | December [removed: 19, 2014] [added: 18, 2015] |
| /s/ MICHAEL H. KALKSTEIN | | Director | | December [removed: 19, 2014] [added: 18, 2015] |
| /s/ JODY S. LINDELL | | Director | | December [removed: 19, 2014] [added: 18, 2015] |
| /s/ GARY S. PETERSMEYER | | Director | | December [removed: 19, 2014] [added: 18, 2015] |
| /s/ STEVEN ROSENBERG | | Director | | December [removed: 19, 2014] [added: 18, 2015] |
| /s/ STANLEY ZINBERG, M.D. | | Director | | December [removed: 19, 2014] [added: 18, 2015] |
| [removed: 2.1] [added: 10.24] | \- [removed: Sale and Purchase] [added: Term Loan] Agreement, dated as of June 30, 2014, among The Cooper Companies, Inc., [removed: CooperVision (UK) Holdings Limited, and] the [removed: sellers] [added: lenders] party thereto, [added: and Keybank National Association, as administrative agent,] incorporated by reference to Exhibit [removed: 2.1] [added: 10.2] of the Company’s Current Report on Form [removed: 8-K] [added: 8‑K] filed July 1, 2014 |
| [removed: 2.2] [added: 10.23] | \- [removed: Sale and Purchase Agreement,] [added: Credit Agreement Amendment,] dated as of [removed: July 1] [added: June 30,] 2014, among The Cooper Companies, Inc., CooperVision [removed: (UK) Holdings Limited, and] [added: International Holding Company, LP,] the [removed: sellers] [added: lenders] party thereto, [added: and Keybank National Association, as administrative agent,] incorporated by reference to Exhibit [removed: 2.2] [added: 10.1] of the Company’s Current Report on Form 8-K filed July 1, 2014 |
| 10.1 | \- [removed: Change in Control] [added: Severance] Agreement entered into as of August 21, 1989, [added: and amended August 15, 2008,] by and between Robert S. Weiss and the Company, incorporated by reference to Exhibit 10.28 to Amendment No. 1 to the Company's Annual Report on Form 10‑K for the fiscal year ended October 31, 1992 |
| [removed: 10.2] [added: 10.3] | \- Change in Control Agreement entered into as of January 3, 2007, and amended September 9, 2008, by and between Albert G. White III and the Company, incorporated by reference to Exhibit 10.2 to the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2013 |
| [removed: 10.3] [added: 10.2] | \- The Cooper Companies, Inc. Change in Control Severance Plan, dated May 21, 2007, incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10‑Q for the fiscal quarter ended July 31, 2007 |
| 10.4 | \- Change in Control Agreement dated as of June 8, 2007, by and between The Cooper Companies, Inc. and Daniel G. McBride, [removed: Esq.] [added: Esq., incorporated by reference to the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2014] |
| 10.7 | \- [removed: 1996 Long-term] [added: The Second Amended and Restated 2006 Long Term] Incentive Plan for Non-Employee Directors of The Cooper Companies, Inc., incorporated by reference to [removed: Appendix A to] the Company's Proxy Statement [removed: for its 1996 Annual Meeting of Stockholders] [added: filed February 2, 2011] |
| 10.8 | \- Amendment No. 1 to [removed: 1996] [added: the Second Amended and Restated 2006] Long-term Incentive Plan for [removed: Non‑Employee] [added: Non-Employee] Directors of The Cooper Companies, Inc., [removed: dated October 10, 1996,] incorporated by reference to Exhibit [removed: 10.14] [added: 10.21] to the Company's Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 1996] [added: 2011] |
| 10.9 | \- Amendment No. 2 to [removed: 1996] [added: the Second Amended and Restated 2006] Long-term Incentive Plan for [removed: Non‑Employee] [added: Non-Employee] Directors of The Cooper Companies, Inc., [removed: dated October 29, 1997,] incorporated by reference to Exhibit [removed: 10.15] [added: 10.22] to the Company's Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 1997] [added: 2012] |
| 10.10 [added: -] | [removed: \-] Amendment No. 3 to [removed: 1996] [added: the Second Amended and Restated 2006] Long-term Incentive Plan for [removed: Non‑Employee] [added: Non-Employee] Directors of The Cooper Companies, Inc., [removed: dated October 29, 1999,] incorporated by reference to Exhibit [removed: 10.15] [added: 10.23] to the Company's Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 2001] [added: 2013] |
| 10.11 | \- [removed: Amendment No. 4 to 1996 Long-term Incentive Plan for Non‑Employee Directors] [added: Form] of [added: Non-Qualified Stock Option Agreement Pursuant to] The Cooper Companies, [removed: Inc., dated October 24, 2000,] [added: Inc. 2006 Long Term Incentive Plan for Non-Employee Directors,] incorporated by reference to Exhibit [removed: 10.16 to] [added: 10.25 of] the Company's Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 2001] [added: 2007] |
| 10.12 | \- [removed: Amendment No. 5 to the 1996 Long-term Incentive Plan for Non-employee Directors] [added: Form] of [added: Restricted Stock Agreement Pursuant to] The Cooper Companies, [removed: Inc.,] [added: Inc. 2006 Long Term Incentive Plan for Non-Employee Directors,] incorporated by reference to Exhibit [removed: 10.17 to] [added: 10.26 of] the Company's Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 2001] [added: 2007] |
| 10.14 | \- [removed: Amendment No. 7] [added: Form of Non-Qualified Stock Option Agreement Pursuant] to the [removed: 1996 Long-term] [added: 2007 Long-Term] Incentive Plan [removed: for Non-employee Directors] of The Cooper Companies, [removed: Inc. dated November 4, 2002,] [added: Inc.,] incorporated by reference to Exhibit [removed: 10.16 to] [added: 10.32 of] the Company's Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 2002] [added: 2007] |
| [removed: 10.15] [added: 10.16] | \- [removed: Amendment No. 8] [added: Form of Deferred Stock Agreement Pursuant] to [removed: 1996 Long-term] [added: the 2007 Long-Term] Incentive Plan [removed: for Non‑Employee Directors] of The Cooper Companies, [removed: Inc. dated October 29, 2003,] [added: Inc.,] incorporated by reference to Exhibit [removed: 10.16 to] [added: 10.34 of] the Company's Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 2003] [added: 2007] |
| [removed: 10.16] [added: 10.15] | \- [removed: Amendment No. 9] [added: Form of UK Tax Approved Stock Option Agreement Pursuant] to [removed: 1996 Long-term] [added: the 2007 Long-Term] Incentive Plan [removed: for Non‑Employee Directors] of The Cooper Companies, [removed: Inc. dated November 9, 2005,] [added: Inc.,] incorporated by reference to Exhibit [removed: 10.17 to] [added: 10.33 of] the Company's Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 2006] [added: 2007] |
| 10.17 [added: -] | [removed: \-] Form of [removed: Non-Qualified Stock Option] [added: Long Term Performance Share Award] Agreement Pursuant to [added: the 2007 Long-Term Incentive Plan of] The Cooper Companies, [removed: Inc. 1996 Long Term Incentive Plan for Non-Employee Directors,] [added: Inc.,] incorporated by reference to [added: Exhibit 10.1 of] the Company's Current Report on Form 8-K dated [removed: December] [added: February] 13, [removed: 2004] [added: 2009] |
| [removed: 10.19] [added: 10.13] | \- The Second Amended and Restated [removed: 2006 Long Term] [added: 2007 Long-Term] Incentive Plan [removed: for Non-Employee Directors] of The Cooper Companies, Inc., incorporated by reference to the Company's Proxy Statement filed February 2, 2011 |
| [removed: 10.26] [added: 10.34 -] | [removed: \- Form of Incentive Stock Option Agreement Pursuant to] The Cooper Companies, Inc. [removed: 2001 Long Term] [added: 2014] Incentive [added: Payment] Plan, incorporated by reference to [added: Exhibit 10.1 of] the Company's Current Report on Form 8-K [removed: dated] [added: filed] December [removed: 13, 2004] [added: 16, 2013] |
| [removed: 10.30] [added: 10.18(a)\-] | [removed: \- Form of Deferred Stock] [added: License] Agreement [removed: Pursuant to the 2007 Long-Term Incentive Plan] [added: dated as] of [removed: The Cooper Companies,] [added: November 19, 2007, by and among CIBA Vision AG, CIBA Vision Corporate and CooperVision,] Inc., incorporated by reference to Exhibit [removed: 10.34 of] [added: 10.41 to] the Company's Annual Report on Form 10-K for the fiscal year ended October 31, [removed: 2007] [added: 2008] |
| Year Ended October 31, 2015 | $ | 6.0 | | | $ | 1.7 | | | $ | (1.7 | ) | | $ | 6.0 | |
| Year Ended October 31, 2014 | $ | 5.3 | | | $ | 1.7 | | | $ | (1.0 | ) | | $ | 6.0 | |
| Year Ended October 31, 2013 | $ | 4.4 | | | $ | 1.5 | | | $ | (0.6 | ) | | $ | 5.3 | |
| Year Ended October 31, 2015 | $ | 14.5 | | | $ | — | | | $ | (1.1 | ) | | $ | 13.4 | |
| 10.32 - | Term Loan Amendment No. 3, dated as of August 21, 2015, among The Cooper Companies, Inc. the lenders party thereto, and Keybank National Association, as administrative agent, incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q filed on September 4, 2015 |
THE COOPER COMPANIES, INC. AND SUBSIDIARIES
| Year Ended October 31, 2014 | $ | 5,261 | | | $ | 1,654 | | | $ | (890 | ) | | $ | 6,025 | |
| Year Ended October 31, 2013 | $ | 4,374 | | | $ | 1,524 | | | $ | (637 | ) | | $ | 5,261 | |
| Year Ended October 31, 2012 | $ | 4,826 | | | $ | (257 | ) | | $ | (195 | ) | | $ | 4,374 | |
| Year Ended October 31, 2012 | $ | — | | | $ | 1,107 | | | $ | — | | | $ | 1,107 | |
Location of
Exhibit in
Exhibit Sequential
Number Description of Document Number System
| | |
| --- | --- |
| 10.13 | \- Amendment No. 6 to the 1996 Long-term Incentive Plan for Non-employee Directors of The Cooper Companies, Inc., incorporated by reference to Exhibit 4.15 to the Company's Registration Statement on Form S-8 dated November 21, 2002 |
| 10.18 | \- Form of Restricted Stock Agreement Pursuant to The Cooper Companies, Inc. 1996 Long Term Incentive Plan for Non-Employee Directors, incorporated by reference to the Company's Current Report on Form 8-K dated December 13, 2004 |
| 10.20 | \- Amendment No. 1 to the Second Amended and Restated 2006 Long-term Incentive Plan for Non-Employee Directors of The Cooper Companies, Inc., incorporated by reference to Exhibit 10.21 to the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2011 |
| 10.21 | \- Amendment No. 2 to the Second Amended and Restated 2006 Long-term Incentive Plan for Non-Employee Directors of The Cooper Companies, Inc., incorporated by reference to Exhibit 10.22 to the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2012 |
| 10.22 - | Amendment No. 3 to the Second Amended and Restated 2006 Long-term Incentive Plan for Non-Employee Directors of The Cooper Companies, Inc., incorporated by reference to Exhibit 10.23 to the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2013 |
| 10.23 | \- Form of Non-Qualified Stock Option Agreement Pursuant to The Cooper Companies, Inc. 2006 Long Term Incentive Plan for Non-Employee Directors, incorporated by reference to Exhibit 10.25 of the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2007 |
| 10.24 | \- Form of Restricted Stock Agreement Pursuant to The Cooper Companies, Inc. 2006 Long Term Incentive Plan for Non-Employee Directors, incorporated by reference to Exhibit 10.26 of the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2007 |
| 10.25 | \- Second Amended and Restated 2001 Long-Term Incentive Plan, incorporated by reference to Appendix 10.2 to the Company's Quarterly Report on Form 10‑Q for the fiscal quarter ended April 30, 2006 |
| 10.27 | \- The Second Amended and Restated 2007 Long-Term Incentive Plan of The Cooper Companies, Inc., incorporated by reference to the Company's Proxy Statement filed February 2, 2011 |
| 10.28 | \- Form of Non-Qualified Stock Option Agreement Pursuant to the 2007 Long-Term Incentive Plan of The Cooper Companies, Inc., incorporated by reference to Exhibit 10.32 of the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2007 |
| 10.29 | \- Form of UK Tax Approved Stock Option Agreement Pursuant to the 2007 Long-Term Incentive Plan of The Cooper Companies, Inc., incorporated by reference to Exhibit 10.33 of the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2007 |
| 10.32(a)\- | Amendment No. 1 to the License Agreement dated as of November 19, 2007, by and among CIBA Vision AG, CIBA Vision Corporate and CooperVision, Inc., incorporated by reference to Exhibit 99.1 of the Company’s Current Report on Form 8-K filed on December 21, 2012 |
| 10.44 - | The Cooper Companies, Inc. 2014 Incentive Payment Plan, incorporated by reference to Exhibit 10.1 of the Company's Current Report on Form 8-K filed December 16, 2013 |
| 10.45 | \- Form of Long Term Performance Share Award Agreement Pursuant to the 2007 Long-Term Incentive Plan of The Cooper Companies, Inc., incorporated by reference to Exhibit 10.1 of the Company's Current Report on Form 8-K dated February 13, 2009 |
An excerpt. Shown here: 40 of 55 rewritten, all 5 added and all 25 removed. The counts are complete. For every sentence, read Item 15. Exhibits and Financial Statement Schedules. in the FY2015 filing and the FY2014 filing.