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EX-31.1 - EXHIBIT 31.1 - WEST PHARMACEUTICAL SERVICES INCex311ceo302certification_2.htm
EX-31.2 - EXHIBIT 31.2 - WEST PHARMACEUTICAL SERVICES INCex312cfo302certification_2.htm
EX-32.1 - EXHIBIT 32.1 - WEST PHARMACEUTICAL SERVICES INCex321ceo906certification_2.htm
EX-32.2 - EXHIBIT 32.2 - WEST PHARMACEUTICAL SERVICES INCex322cfo906certification_2.htm
EX-21 - EXHIBIT 21 - WEST PHARMACEUTICAL SERVICES INCex21listofsubsidiaries_2015.htm
EX-23 - EXHIBIT 23 - WEST PHARMACEUTICAL SERVICES INCex23consent_2015.htm

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
FORM 10-K

(Mark One)
þ
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2015
or
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from            to

Commission File Number 1-8036
WEST PHARMACEUTICAL SERVICES, INC.
(Exact name of registrant as specified in its charter)
Pennsylvania
23-1210010
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification Number)
 
 
530 Herman O. West Drive, Exton, PA
19341-0645
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: 610-594-2900

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange on which registered
Common Stock, par value $.25 per share
New York Stock Exchange
Securities registered pursuant to Section 12 (g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes þ No o

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No þ

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ No o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
þ
 
Accelerated filer
o
Non-accelerated filer
o
(Do not check if a smaller reporting company)
Smaller reporting company
o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ

The aggregate market value of the voting stock held by non-affiliates of the registrant as of June 30, 2015 was approximately $4,181,975,535 based on the closing price as reported on the New York Stock Exchange.

As of January 31, 2016, there were 72,333,516 shares of the registrant's common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE
Document
Parts Into Which Incorporated
Proxy Statement for the Annual Meeting of Shareholders to be held May 3, 2016
Part III




TABLE OF CONTENTS

 
Page
BUSINESS
RISK FACTORS
UNRESOLVED STAFF COMMENTS
PROPERTIES
LEGAL PROCEEDINGS
MINE SAFETY DISCLOSURES
 
 
 
 
 
MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
SELECTED FINANCIAL DATA
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
CONTROLS AND PROCEDURES
OTHER INFORMATION
 
 
 
 
 
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
EXECUTIVE COMPENSATION
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
PRINCIPAL ACCOUNTING FEES AND SERVICES
 
 
 
 
 
EXHIBITS, FINANCIAL STATEMENT SCHEDULES
 
 
 
 
 
 


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PART I

ITEM 1. BUSINESS
General

West Pharmaceutical Services, Inc. (which may be referred to as West, the Company, we, us or our) is a manufacturer of components and systems for the packaging and delivery of injectable drugs as well as components for the pharmaceutical, healthcare and consumer products industries. Our products include stoppers and seals for vials, prefillable syringe components and systems, components for intravenous and blood collection systems, safety and administration systems, advanced injection systems, and contract design and manufacturing services. Our customers include the leading global producers of pharmaceuticals, biologics, medical devices and consumer products. The Company was incorporated under the laws of the Commonwealth of Pennsylvania on July 27, 1923.

All trademarks and registered trademarks used in this report are the property of West Pharmaceutical Services, Inc., either directly or indirectly through its subsidiaries unless noted otherwise. Daikyo Crystal Zenith® (“CZ®”) is a registered trademark of Daikyo Seiko, Ltd. ("Daikyo").

Throughout this report, references to “Notes” refer to the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K ("Form 10-K"), unless otherwise indicated.

West Website

We maintain a website at www.westpharma.com. Our Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are available on our website under the Investors - SEC Filings caption as soon as reasonably practical after we electronically file the material with, or furnish it to, the U.S. Securities and Exchange Commission (“SEC”). These filings are also available to the public over the Internet at the SEC's website at www.sec.gov. You may also read and copy any document we file at the SEC's Public Reference Room at 100 F. Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room.

Throughout this Form 10-K, we incorporate by reference certain information from parts of other documents filed with the SEC and from our Proxy Statement for the 2016 Annual Meeting of Shareholders (“2016 Proxy Statement”), which will be filed with the SEC within 120 days following the end of our 2015 fiscal year. Our 2016 Proxy Statement will be available on our website on or about March 31, 2016, under the caption Investors - Annual Report & Proxy.

Information about our corporate governance, including our Corporate Governance Principles and Code of Business Conduct, as well as information about our Directors, Board Committees, Committee Charters, and instructions on how to contact the Board is available on our website under the Investors - Corporate Governance caption. We intend to make any required disclosures regarding any amendments of our Code of Business Conduct or waivers granted to any of our directors or executive officers under the heading Code of Business Conduct on our website. Information relating to the West Pharmaceutical Services Dividend Reinvestment Plan is also available on our website under the Investors - Transfer Agent/Dividend Reinvestment caption.

We will provide any of the foregoing information without charge upon written request to our Corporate Secretary, West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341.


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Business Segments

In 2015, our business operations consisted of two reportable segments, the Pharmaceutical Packaging Systems segment ("Packaging Systems") and the Pharmaceutical Delivery Systems segment (“Delivery Systems”). Beginning in 2016, we are changing our organization and reporting structure for our next phase of growth and development, which will result in a change to Proprietary Products and Contract-Manufactured Products as reportable segments. The Proprietary Products reportable segment, which will combine the existing Packaging Systems segment with the proprietary products portion of the existing Delivery Systems segment, will develop commercial, operational, and innovation strategies across our global network, with specific emphasis on product offerings to biologic, generic, and pharmaceutical customers. The Contract-Manufactured Products reportable segment, which will consist of the contract manufacturing portion of the existing Delivery Systems segment, will serve as a fully integrated business focused on the design, manufacture, and automated assembly of complex assemblies for pharmaceutical and medical device customers.

The information and discussion included in this Form 10-K reflects the structure in place as of December 31, 2015.

Packaging Systems Segment

Our Packaging Systems segment includes primary packaging components and systems for injectable drug delivery, including stoppers and seals for vials, closures and other components used in syringe, intravenous and blood collection systems, and prefillable syringe components. The growth strategy for Packaging Systems includes organic growth through market segmentation, new-product innovation, strategic acquisitions and geographic expansion. We have manufacturing facilities in North and South America, Europe and Asia Pacific, with affiliated companies in Mexico and Japan. See Item 2, Properties, for additional information on our manufacturing and other sites.

Packaging Systems consists of three operating segments - Americas, Europe and Asia Pacific - which are aggregated for reporting purposes.

Packaging Systems' products generally consist of elastomeric components offered in a variety of standard and customer-specific configurations and formulations, which are available with advanced barrier films and coatings to enhance their performance. West FluroTec® barrier film is applied to reduce the risk of product loss by contamination and protect the shelf life of packaged drugs. We also apply a fluoropolymer laminate to the surface of stoppers and plungers to improve compatibility between the closure and the drug. B2-coating is a coating applied to the surface of stoppers and plungers which eliminates the need for conventional silicone application. It helps manufacturers reduce product rejections due to trace levels of silicone molecules found in non-coated packaged drug compounds. FluroTec and B2-coating technologies are licensed from Daikyo.

In addition, our Westar® RS and Westar® RU post-manufacturing processes are documented and fully validated procedures for washing, siliconizing and sterilizing stoppers and syringe components. The Westar RS process prepares components for introduction into the customer's sterilizer and the Westar RU process provides sterilized components. These processes increase the overall efficiency of injectable drug production by outsourcing component processing, thereby eliminating steps otherwise required in our customers' manufacturing processes, and help to assure compliance with the latest regulatory requirements for component preparation. We also offer Envision™ components that are inspected using automated vision inspection systems, ensuring that components (plungers and stoppers) meet enhanced quality specifications for visible and subvisible particulate contamination. In 2015, we launched Daikyo RUV components, which are manufactured using clean, high-quality elastomer formulations and then washed, camera-inspected and sterilized to help reduce the customer’s manufacturing footprint, streamline processes, minimize risks around component preparation and eliminate bioburden.

Our NovaPure® components, which include serum and lyophilization stoppers and syringe plungers, incorporate quality by design principles and are manufactured utilizing advanced process technologies. The closures provide the highest levels of quality to the market, helping to ensure the safety, efficacy and purity of injectable drug products.


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Our tamper-evident Flip-Off® seals are sold in a wide range of sizes and colors to meet customers' needs for product identification and differentiation. The seals can be provided using proprietary printing for cautionary statements and embossing technology that can serve as a counterfeiting deterrence. Our newest sterile drug vial seal, the Flip-Off PlusRU seal, provides drug manufacturers around the world with ready-to-use, high-quality seals that consistently achieve reproducible and safe container integrity for drug products while minimizing levels of bioburden and particulates.

As an adjunct to our Packaging Systems products, we offer contract analytical laboratory services for testing and evaluating primary drug-packaging components and their compatibility with the contained drug formulation. West Analytical Services provides customers with in-depth knowledge and analysis of the interaction and compatibility of drug products with elastomer, glass and plastic packaging components. Our analytical laboratories also provide specialized testing for complete drug delivery systems.

See Note 17, Segment Information, for net sales and asset information for Packaging Systems.

Delivery Systems Segment

Our Delivery Systems segment includes safety and administration systems, multi-component systems for drug containment and administration and a variety of custom contract-manufacturing solutions targeted to the healthcare and consumer-products industries. Delivery Systems has expertise in product design and development, including in-house mold design and construction, an engineering center for developmental and prototype tooling, process design and validation and high-speed automated assemblies. In addition, Delivery Systems is responsible for the continued development and commercialization of our line of proprietary healthcare, administrative and advanced injection systems, including Daikyo CZ®, SmartDose® and other systems. Delivery Systems has manufacturing operations in North America and Europe. See Item 2, Properties, for additional information on our manufacturing and other sites.

Delivery Systems includes a variety of products and services, which are described below:

The Daikyo CZ 1ml long Insert Needle syringe system is the market's first polymer syringe system without silicone oil lubrication applied to the barrel or plunger that incorporates an insert-molded needle to avoid the need for adhesive. The luer lock version of the Daikyo CZ syringe system was introduced previously, along with several sizes of sterile vials. Additional sizes of vials continue to be introduced. CZ technology is licensed from Daikyo.

The development of our SmartDose electronic wearable injector continues to gain momentum in the marketplace, with multiple active development programs in place. This system is designed for controlled, subcutaneous delivery of high volume and high viscosity drugs, using prefillable Daikyo CZ cartridges. The system is fully programmable, has a single push-button operation and a hidden needle for safety.

The ConfiDose® auto-injector and SelfDoseTM self-injection systems enhance patient compliance and safety. The needle remains automatically shielded at all times. These systems eliminate preparation steps and simplify the injection of drugs, providing patients with a sterile, single-use disposable system that can be readily used at home.

Our administration systems include sterile devices for the preparation and administration of drug products, including patented products such as the MixJect® transfer device, the Mix2Vial® needleless reconstitution system, the Vial2Bag® system, and a variety of vial adapters.

Examples of our safety systems that are designed to prevent needle sticks are éris™ and NovaGuard® SA for prefilled syringes and NovaGuard® LP for luer lock syringes.


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We offer customer contract-manufacturing and assembly solutions, which use such technologies as multi-component molding, in-mold labeling, ultrasonic welding and clean room molding and device assembly used to manufacture customer-owned components and devices used in surgical, diagnostic, ophthalmic, other drug delivery systems, and consumer products.

See Note 17, Segment Information, for net sales and asset information for Delivery Systems.

International

We have significant operations outside of the United States ("U.S."), which are managed through the same business segments as our U.S. operations – Packaging Systems and Delivery Systems. Sales outside of the U.S. accounted for 52.0% of consolidated net sales in 2015. For a geographic breakdown of sales, see Note 17, Segment Information.

Although the general business processes are similar to the domestic business, international operations are exposed to additional risks. These risks include currency fluctuations relative to the U.S. Dollar ("USD"), multiple tax jurisdictions and, particularly in South America and Israel, political and social issues that could destabilize local markets and affect the demand for our products.

See further discussion of our international operations, the risks associated with our international operations, and our attempt to minimize some of these risks in Part I, Item 1A, Risk Factors; Part II, Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations under the caption Financial Condition, Liquidity and Capital Resources; Part II, Item 7A, Quantitative and Qualitative Disclosures About Market Risk; Note 1 under the captions Financial Instruments and Foreign Currency Translation; and Note 9, Derivative Financial Instruments.

Raw Materials

We use three basic raw materials in the manufacture of our products: elastomers, aluminum and plastic. Elastomers include both natural and synthetic materials. We currently have access to adequate supplies of these raw materials to meet our production needs through agreements with suppliers.
We employ a supply-chain management strategy in our business segments, which involves purchasing from integrated suppliers that control their own sources of supply. Due to regulatory control over our production processes, and the cost and time involved in qualifying suppliers, we rely on single-source suppliers for many critical raw materials. We purchase certain of our raw materials in the open market. This strategy increases the risk that our supply chain may be interrupted in the event of a supplier production problem. These risks are managed, where possible, by selecting suppliers with multiple manufacturing sites, rigorous quality control systems, surplus inventory levels and other methods of maintaining supply in case of an interruption in production.

Intellectual Property
Intellectual property, including patents, trade secrets and know-how, is important to our business. We own or license intellectual property rights, including issued patents and pending patent applications in the U.S. and in other countries that relate to various aspects of our products. In particular, key value-added and proprietary products and processes are licensed from Daikyo. Our intellectual property rights have been useful in establishing our market share and in the growth of our business, and are expected to continue to be of value in the future.
Seasonality
Although our Packaging Systems business is not inherently seasonal, sales and operating profit in the second half of the year are typically lower than the first half primarily due to scheduled plant shutdowns in conjunction with our customers' production schedules and the year-end impact of holidays on production.
Our Delivery Systems business is not inherently seasonal.

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Working Capital
We are required to carry significant amounts of inventory to meet customer requirements. In addition, some of our supply agreements require us to purchase inventory in bulk orders, which increases inventory levels but decreases the risk of supply interruption. Levels of inventory are also influenced by the seasonal patterns addressed above. For a more detailed discussion of working capital, please see the discussion in Part II, Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations under the caption Financial Condition, Liquidity and Capital Resources.
Marketing
Our Packaging Systems customers include most of the major branded pharmaceutical, generic and biopharmaceutical companies in the world. Packaging Systems components and other products are sold to major pharmaceutical, biotechnology and hospital supply/medical device companies, which incorporate them into their products for distribution to the ultimate end-user.
Our Delivery Systems segment sells to many of the world's largest pharmaceutical, biopharmaceutical and medical device companies and to large customers within the consumer and food-and-beverage industries. Delivery Systems components generally are incorporated into our customers' manufacturing lines for further processing or assembly.
Our products and services are distributed primarily through our own sales force and distribution network, with limited use of contract sales agents and regional distributors.
Our ten largest customers accounted for 42.0% of our consolidated net sales in 2015, but none of these customers individually accounted for more than 10% of net sales. See Note 17, Segment Information, for information on sales by significant product group.

Order Backlog

Order backlog includes firm orders placed by customers for manufacture over a period of time according to their schedule or upon confirmation by the customer. We also have contractual arrangements with a number of our customers. Products covered by these contracts are included in our backlog only as orders are received. Order backlog may be positively or negatively impacted by several factors, including customer ordering patterns and the necessary lead-time to deliver customer orders. Order backlog is one of many measures we use to understand future demand, and should not be considered in isolation to predict future sales growth.

At December 31, 2015 and 2014, the order backlog for Packaging Systems was $413.2 million and $339.7 million, respectively. The increase in backlog primarily reflects changes in customer ordering patterns and extended lead-times for certain high-value products, partially offset by an unfavorable foreign currency impact. In 2015, we had orders being placed further in advance by certain customers, some as much as a year, while others focused more on short-term stock-building. The entire order backlog for Packaging Systems at December 31, 2015 is expected to be filled during 2016.

The majority of Delivery Systems' manufacturing activity is governed by contractual volume expectations, with terms between one and three years, subject to periodic revisions based on customer requirements.

Competition

We compete with several companies across our Packaging Systems product lines. Because of the special nature of our pharmaceutical packaging components and our long-standing participation in the market, competition is based primarily on product design and performance, although total cost is becoming increasingly important as pharmaceutical companies continue with aggressive cost-control programs across their operations.
We differentiate ourselves from our competition as an integrated drug packaging and delivery systems global supplier that can provide pre-sale primary packaging support and engineering development, analytical services,

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regulatory expertise and after-sale technical support. Customers also appreciate the global scope of West's manufacturing capability and our ability to produce many products at multiple sites.
Our Delivery Systems business operates in very competitive markets for both healthcare and consumer products. The competition varies from smaller regional companies to large global molders. Given the extreme cost pressures they face, many of our customers look off-shore to reduce cost. We differentiate ourselves by leveraging our global capability and by employing new technologies such as high-speed automated assembly, insert-molding, multi-shot molding and expertise with multiple-piece closure systems.

There are a small number of competitors supplying medical devices and medical devices components. We compete for this market on the basis of our reputation for quality and reliability in engineering and project management, diverse contract manufacturing capabilities and knowledge of and experience in complying with U.S. Food and Drug Administration ("FDA") requirements. We also have specialized knowledge of container and closure components, which is integral to developing delivery systems. With our range of proprietary technologies, we compete with new and established companies in the area of drug delivery devices, including suppliers of prefillable syringes, auto-injectors, safety needles and other proprietary systems.
Research and Development Activities
We maintain our own research-scale production facilities and laboratories for developing new products, and offer contract engineering design and development services to assist customers with new product development. Our quality control, regulatory and laboratory testing capabilities are used to ensure compliance with applicable manufacturing and regulatory standards for primary and secondary pharmaceutical packaging components. The engineering departments are responsible for product and tooling design and testing, and for the design and construction of processing equipment. We continue to seek new innovative opportunities for acquisition, licensing, partnering or development of products, services and technologies that serve the injectable drug containment and delivery market. Research and development spending will continue to increase as we pursue innovative strategic platforms in prefillable syringes, injectable containers, advanced injection and safety and administration systems.
Commercial development of our new products and services for medical and pharmaceutical applications commonly requires several years. New products that we develop may require separate approval as medical devices, and products that are intended to be used in the packaging and delivery of pharmaceutical products will be subject to both customer acceptance of our products and regulatory approval of the customer's products following our development period.

We spent $14.4 million in 2015, $16.3 million in 2014, and $15.1 million in 2013 on research and development for Packaging Systems. Delivery Systems incurred research and development costs of $19.7 million, $21.0 million, and $22.8 million in the years 2015, 2014 and 2013, respectively.

Environmental Regulations

We are subject to various federal, state and local provisions regulating the discharge of materials into the environment or otherwise relating to the protection of the environment. Our compliance with these laws and regulations has not had a material impact on our financial position, results of operations or cash flows. There were no material capital expenditures for environmental control facilities in 2015 and there are no material expenditures planned for such purposes in 2016.

Employees

As of December 31, 2015, we employed approximately 7,100 people in our operations throughout the world.

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ITEM 1A. RISK FACTORS
The statements in this section describe major risks to our business and should be considered carefully. In addition, these statements constitute our cautionary statements under the Private Securities Litigation Reform Act of 1995.

Our disclosure and analysis in this Form 10-K contains some forward-looking statements that are based on management's beliefs and assumptions, current expectations, estimates and forecasts. We also provide forward-looking statements in other materials we release to the public as well as oral forward-looking statements. Such statements give our current expectations or forecasts of future events. They do not relate strictly to historical or current facts. We have attempted, wherever possible, to identify forward-looking statements by using words such as “estimate,” “expect,” “intend,” “believe,” “plan,” “anticipate” and other words and terms of similar meaning. In particular, these include statements relating to future actions, business plans and prospects, new products, future performance or results of current or anticipated products, sales efforts, expenses, interest rates, foreign-exchange rates, economic effects, the outcome of contingencies, such as legal proceedings, and financial results.

Many of the factors that will determine our future results are beyond our ability to control or predict. Achievement of future results is subject to known or unknown risks or uncertainties, and therefore, actual results could differ materially from past results and those expressed or implied in any forward-looking statement. You should bear this in mind as you consider forward-looking statements.

Unless required by applicable securities law, we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise. We also refer you to further disclosures we make on related subjects in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K to the SEC.

Our operating results may be adversely affected by unfavorable economic and market conditions.

The current uncertainty in the global economy, including the continuing effects of recession or slow economic growth in the U.S., Europe, and emerging markets in Asia and South America, may negatively affect our operating results. Examples of the effects of these continuing global economic challenges include: our suppliers' and our customers' inability to access the credit markets at commercially reasonable rates; reduction in sales due to customers decreasing their inventories in the near-term or long-term or due to liquidity difficulties; reduction in sales due to shortages of materials we purchase from our suppliers; reduction in research and development efforts and expenditures by our customers; our inability to hedge our currency and raw material risks sufficiently or at commercially reasonable prices; insolvency of suppliers or customers; inflationary pressures on our supplies or our products; and increased expenses due to growing taxation of corporate profits or revenues. Our operating results in one or more geographic regions may also be affected by uncertain or changing economic conditions within that region. If economic and market conditions in the U.S., Europe, or in emerging markets, weaken further, we may experience material adverse impacts on our business, financial condition and results of operations.

Our sales and profitability are largely dependent on the sale of drug products delivered by injection and the packaging of drug products. If the products developed by our customers in the future use another delivery system, our sales and profitability could suffer.

Our business depends to a substantial extent on customers' continued sales and development of products that are delivered by injection. If our customers fail to continue to sell, develop and deploy injectable products or we are unable to develop new products that assist in the delivery of drugs by alternative methods, our sales and profitability may suffer.


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Changes in foreign currency exchange rates could have a material adverse effect on our business and/or results of operations.

Our business is subject to foreign currency exchange rate fluctuations. Sales outside of the U.S. accounted for 52.0% of our consolidated net sales in 2015 and we anticipate that sales from international operations will continue to represent a significant portion of our total sales in the future. In addition, many of our manufacturing facilities and suppliers are located outside of the U.S. Further, we intend to continue our expansion into emerging and/or faster-growing markets outside of the U.S. in the future. Virtually all of our international sales, assets and related operating costs and expenses are earned, valued or incurred in the currency of the local country, primarily the Euro, the Singapore Dollar, and the Danish Krone. In addition, we are exposed to Japanese Yen ("Yen"), as we maintain a 25% ownership interest in, and we purchase finished goods and other materials from, Daikyo. We are also exposed to currencies in emerging market countries, such as the Chinese Yuan, the Indian Rupee, and various South American currencies, including the Venezuelan Bolivar and the Brazilian Real. Our consolidated financial statements are presented in USD, and, therefore, we must translate the reported values of our foreign assets, liabilities, revenues and expenses into USD, which can result in significant fluctuations in the amount of those assets, liabilities, revenues or expenses. The exchange rates between these foreign currencies and USD in recent years have fluctuated significantly and may continue to do so in the future. Increases or decreases in the value of USD compared to these foreign currencies may negatively affect the value of these items in our consolidated financial statements, which could have a material adverse effect on our operating results.

In addition to translation risks, we incur currency transaction risk when we or one of our subsidiaries enters into a purchase or sales transaction in a currency other than that entity's local currency. In order to reduce our exposure to fluctuations in certain exchange rates, we have entered, and expect to continue to enter, into hedging arrangements, including the use of financial derivatives. There can be no certainty that we will be able to enter into or maintain hedges of these currency risks, or that our hedges will be effective, which could have a significant effect on our financial condition and operating results.

If we are unable to provide comparative value advantages, timely fulfillment of customer orders or resist pricing pressure, we will have to reduce our prices, which may reduce our profit margins.

We compete with several companies across our major product lines. Because of the special nature of these products, competition is based primarily on product design and performance, although total cost is becoming increasingly important as pharmaceutical companies continue with aggressive cost-control programs across their operations. Competitors often compete on the basis of price. We differentiate ourselves from our competition as a "full-service, value-added" global supplier that is able to provide pre-sale compatibility studies and other services and sophisticated post-sale technical support on a global basis. However, we face continued pricing pressure from our customers and competitors. If we are unable to resist or to offset the effects of continued pricing pressure through our value-added services, improved operating efficiencies and reduced expenditures, or if we have to reduce our prices, our sales and profitability may suffer.

Consolidation in the pharmaceutical and healthcare industries could adversely affect our future revenues and operating income.

The pharmaceutical and medical technology industries have experienced a significant amount of consolidation. As a result of this consolidation, competition to provide goods and services to customers has increased. In addition, group purchasing organizations and integrated health delivery networks have served to concentrate purchasing decisions for some customers, which has placed pricing pressure on suppliers. Further consolidation within the industries we serve could exert additional pressure on the prices of our products.


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We are subject to regulation by governments around the world, and if these regulations are not complied with, existing and future operations may be curtailed, and we could be subject to liability.

The design, development, manufacturing, marketing and labeling of certain of our products and our customers' products that incorporate our products are subject to regulation by governmental authorities in the U.S., Europe and other countries, including the FDA and the European Medicines Agency. Complying with governmental regulation can be costly and can result in required modification or withdrawal of existing products and a substantial delay in the introduction of new products. Failure to comply with applicable regulatory requirements or failure to obtain regulatory approval for a new product could result in expenses and actions that could adversely affect our business and financial performance.

Products incorporating our technologies are subject to regulations and extensive approval or clearance processes, which make the timing and success of new-product commercialization difficult to predict.

The process of obtaining FDA and other required regulatory approvals is expensive and time-consuming. Historically, most medical devices incorporating our technologies have been subject to the FDA's 510(k) marketing approval process, which typically lasts from six to nine months. Supplemental or full pre-market approval reviews require a significantly longer period, delaying commercialization. Pharmaceutical products incorporating our technologies are subject to the FDA's New Drug Application process, which typically takes a number of years to complete. Additionally, biotechnology products incorporating our technologies are subject to the FDA's Biologics License Application process, which also typically takes a number of years to complete. Outside of the U.S., sales of medical devices and pharmaceutical or biotechnology products are subject to international regulatory requirements that vary from country to country. The time required to obtain approval for sale internationally may be longer or shorter than that required for FDA approval.

Changes in the regulation of drug products and devices may increase competitive pressure and adversely affect our business.

An effect of the governmental regulation of our customers' drug products, devices, and manufacturing processes is that compliance with regulations makes it costly and time-consuming for customers to substitute or replace components and devices produced by one supplier with those from another. The regulation of our customers' products that incorporate our components and devices has increased over time. If the applicable regulations were to be modified in a way that reduced the cost and time involved for customers to substitute one supplier's components or devices for those made by another, it is likely that the competitive pressure would increase and adversely affect our sales and profitability.

If we are not successful in protecting our intellectual property rights, we may harm our ability to compete.

Our patents, trademarks and other intellectual property are important to our business. We rely on patent, trademark, copyright, trade secret, and other intellectual property laws, as well as nondisclosure and confidentiality agreements and other methods, to protect our proprietary information, technologies and processes. We also have obligations with respect to the non-use and non-disclosure of third party intellectual property. We may need to engage in litigation or similar activities to enforce our intellectual property rights, to protect our trade secrets or to determine the validity and scope of proprietary rights of others. Any such litigation could require us to expend significant resources and divert the efforts and attention of our management and other personnel from our business operations. We cannot assure you that the steps we will take to prevent misappropriation, infringement or other violation of our intellectual property or the intellectual property of others will be successful. In addition, effective patent, copyright, trademark and trade secret protection may be unavailable or limited for some of our intellectual property in some countries. Failure to protect our intellectual property could harm our business and results of operations. In addition, if relevant and effective patent protection is not available or has expired, we may not prevent competitors from independently developing products and services similar or duplicative to ours.


11



Disruption in our manufacturing facilities could have a material adverse effect on our ability to make and sell products and have a negative impact on our reputation, performance or financial condition.

We have manufacturing sites throughout the world. In addition, in some instances, the manufacturing of certain product lines is concentrated in one or more of our plants. The functioning of our manufacturing and distribution assets and systems could be disrupted for reasons either within or beyond our control, including: extreme weather or longer-term climatic changes; natural disasters; pandemic; war; accidental damage; disruption to the supply of material or services; product quality and safety issues; systems failure; workforce actions; or environmental contamination. There is a risk that incident management systems in place may prove inadequate and that any disruption may materially adversely affect our ability to make and sell products and, therefore, materially adversely affect our reputation, performance or financial condition.

The medical technology industry is very competitive and customer demands and/or new products in the marketplace could cause a reduction in demand.

The medical technology industry is subject to rapid technological changes, and we face significant competition across our product lines and in each market in which our products are sold. We face this competition from a wide range of companies. These include large medical device companies, some of which have greater financial and marketing resources than we do. We also face competition from firms that are more specialized than we are with respect to particular markets. In some instances, competitors, including pharmaceutical companies, also offer, or are attempting to develop, alternative therapies for diseases that may be delivered without a medical device. The development of new or improved products, processes or technologies by other companies (such as needle-free injection technology) may render some of our products or proposed products obsolete or less competitive. In addition, failure to meet increased customer quality expectations could cause a reduction in demand.

Our international sales and operations are subject to risks and uncertainties that vary by country and which could have a material adverse effect on our business and/or results of operations.

We conduct business in most of the major pharmaceutical markets in the world. Our international operations and our ability to implement our overall business strategy (including our plan to continue expanding into emerging and/or faster-growing markets outside of the U.S.) are subject to risks and uncertainties that can vary by country, and include: transportation delays and interruptions; political and economic instability and disruptions; imposition of duties and tariffs; import and export controls; the risks of divergent business expectations or cultural incompatibility inherent in establishing and maintaining operations in foreign countries; difficulties in staffing and managing multi-national operations; labor strikes and/or disputes; and potentially adverse tax consequences. Limitations on our ability to enforce legal rights and remedies with third parties or our joint venture partners outside of the U.S. could also create exposure. In addition, we may not be able to operate in compliance with foreign laws and regulations, or comply with applicable customs, currency exchange control regulations, transfer pricing regulations or any other laws or regulations to which we may be subject, in the event that these laws or regulations change. Any of these events could have an adverse effect on our international operations in the future by reducing the demand for our products, decreasing the prices at which we can sell our products or otherwise have an adverse effect on our financial condition, results of operations and cash flows.
 
Disruptions in the supply of key raw materials could adversely impact our operations.

We generally purchase our raw materials and supplies required for the production of our products in the open market. For reasons of quality assurance, sole source availability or cost effectiveness, many components and raw materials are available and/or purchased only from a single supplier. Due to the stringent regulations and requirements of the FDA and other regulatory authorities regarding the manufacture of our products, we may not be able to quickly establish additional or replacement sources for these components or materials or do so without excessive cost. As a result, a reduction or interruption in manufacturing, or an inability to secure alternative sources of raw materials or components, could have a material adverse effect on our business and/or results of operations.


12



Raw material and energy prices have a significant impact on our profitability. If raw material and/or energy prices increase, and we cannot pass those price increases on to our customers, our profitability and financial condition may suffer.

We use three basic raw materials in the manufacture of our products: elastomers (which include synthetic and natural material), aluminum and plastic. In addition, our manufacturing facilities consume a wide variety of energy products to fuel, heat and cool our operations. Supply and demand factors, which are beyond our control, generally affect the price of our raw materials and utility costs. If we are unable to pass along increased raw material prices and energy costs to our customers, our profitability, and thus our financial condition, may be adversely affected. The prices of many of these raw materials and utilities are cyclical and volatile. For example, the prices of certain commodities, particularly petroleum-based raw materials, have in the recent past exhibited rapid changes, affecting the cost of synthetic elastomers and plastic. While we generally attempt to pass along increased costs to our customers in the form of sales price increases, historically there has been a time delay between raw material and/or energy price increases and our ability to increase the prices of our products. In some circumstances, we may not be able to increase the prices of our products due to competitive pressure and other factors.

If we are not timely or successful in new-product innovation or the development and commercialization of proprietary multi-component systems, our future revenues and operating income could be adversely affected.

Our growth partly depends on new-product innovation and the development and commercialization of proprietary multi-component systems for injectable drug administration and other healthcare applications (such as the Daikyo CZ ready-to-use prefilled syringes and the SmartDose systems). Product development and commercialization is inherently uncertain and is subject to a number of factors outside of our control, including any necessary regulatory approvals and commercial acceptance for the products. The ultimate timing and successful commercialization of new products and systems requires substantial evaluations of the functional, operational, clinical and economic viability of the Company's products. In addition, the timely and adequate availability of filling capacity is essential to both conducting definitive stability trials and the timing of first commercialization of customers' products in CZ prefilled syringes. Delays, interruptions or failures in developing and commercializing new-product innovations or proprietary multi-component systems could adversely affect future revenues and operating income. In addition, adverse conditions may also result in future charges to recognize impairment in the carrying value of our goodwill and other intangible assets, which could have a material adverse effect on our financial results.

We may not succeed in finding and completing acquisition or other strategic transactions, if any, which could have an adverse effect on our business and results of operations.

We have historically engaged in acquisition activity and we may in the future engage in acquisitions or other strategic transactions, such as joint ventures or investments in other entities. We may be unable to identify suitable targets, opportunistic or otherwise, for acquisitions or other strategic transactions in the future. If we identify a suitable candidate, our ability to successfully implement the strategic transaction would depend on a variety of factors including our ability to obtain financing on acceptable terms, and to comply with the restrictions contained in our debt agreements. Strategic transactions involve risks, including those associated with integrating the operations or maintaining the operations as separate (as applicable), financial reporting, disparate technologies and personnel of acquired companies, joint ventures or related companies; managing geographically dispersed operations or other strategic investments; the diversion of management's attention from other business concerns; the inherent risks in entering markets or lines of business in which we have either limited or no direct experience; unknown risks; and the potential loss of key employees, customers and strategic partners of acquired companies, joint ventures or companies in which we may make strategic investments. We may not successfully integrate any businesses or technologies we may acquire or strategically develop in the future and may not achieve anticipated revenue and cost benefits relating to any such strategic transactions. Strategic transactions may be expensive, time consuming and may strain our resources. Strategic transactions may not be accretive to our earnings and may negatively impact our results of operations as a result of, among other things, the incurrence of debt, one-time write-offs of goodwill and amortization expenses of other intangible assets. In addition, strategic transactions that we may pursue could result in dilutive issuances of equity securities.


13



Product defects could adversely affect the results of our operations.

The design, manufacture and marketing of medical devices involve certain inherent risks. Manufacturing or design defects, unanticipated use of our products, or inadequate disclosure of risks relating to the use of our products can lead to injury or other adverse events. These events could lead to recalls or safety alerts relating to our products (either voluntary or required by the FDA or similar governmental authorities in other countries), and could result, in certain cases, in the removal of a product from the market. A recall could result in significant costs, as well as negative publicity and damage to our reputation that could reduce demand for our products. Personal injuries relating to the use of our products can also result in product liability claims being brought against us. In some circumstances, such adverse events could also cause delays in new product approvals.

Our operations must comply with environmental statutes and regulations, and any failure to comply could result in extensive costs which would harm our business.

The manufacture of some of our products involves the use, transportation, storage and disposal of hazardous or toxic materials and is subject to various environmental protection and occupational health and safety laws and regulations in the countries in which we operate. This has exposed us in the past, and could expose us in the future, to risks of accidental contamination and events of non-compliance with environmental laws. Any such occurrences could result in regulatory enforcement or personal injury and property damage claims or could lead to a shutdown of some of our operations, which could have an adverse effect on our business and results of operations. We currently incur costs to comply with environmental laws and regulations and these costs may become more significant.

A loss of key personnel or highly skilled employees could disrupt our operations.

Our executive officers are critical to the management and direction of our businesses. Our future success depends, in large part, on our ability to retain these officers and other key employees, including people in technical, marketing, sales and research positions. Competition for experienced employees, particularly for persons with specialized skills, can be intense. Our ability to recruit such talent will depend on a number of factors, including compensation and benefits, work location and work environment. If we cannot effectively recruit and retain qualified executives and employees, our business could be adversely affected. Although we believe that we will be able to attract and retain talented personnel and replace key personnel should the need arise, our inability to do so on a timely basis could disrupt the operations of the unit affected or our overall operations. In addition, because of the complex nature of many of our products and programs, we are generally dependent on an educated and highly skilled engineering staff and workforce. Our operations could be disrupted by a shortage of available skilled employees.

The uncertain effects of potential climate change legislation could lead to significantly increased costs.

If legislation or regulations are enacted or promulgated in the U.S., Europe or Asia or any other jurisdictions in which we do business that limit or reduce allowable greenhouse gas emissions and other emissions, such restrictions could have a significant effect on our operating and financial decisions, including those involving capital expenditures to reduce emissions, and our results of operations. Our manufacturing operations may not be able to operate as planned if we are not able to comply with new legal and regulatory legislation around climate change, or it may become too costly to operate in a profitable manner. Additionally, suppliers' added expenses could be passed on to us in the form of higher prices and we may not be able to pass on such expenses to our customers through price increases.


14



Federal healthcare reform may adversely affect our results of operations.

The Patient Protection and Affordable Care Act (the “PPACA”) was enacted in March 2010. The PPACA reduces Medicare and Medicaid payments to hospitals, clinical laboratories and pharmaceutical companies, and could otherwise reduce the volume of medical procedures. These factors, in turn, could result in reduced demand for our products and increased downward pricing pressure. It is also possible that the PPACA will result in lower reimbursements for our customers' products. While the PPACA is intended to expand health insurance coverage to uninsured persons in the U.S., the impact of any overall increase in access to healthcare on sales of West's products is uncertain at this time. Our sales depend, in part, on the extent to which pharmaceutical companies and healthcare providers and facilities are reimbursed by government authorities, private insurers and other third-party payers for the costs of our products. The coverage policies and reimbursement levels of third-party payers, which can vary among public and private sources, may affect which products customers purchase and the prices they are willing to pay for these products in a particular jurisdiction. Legislative or administrative reforms to reimbursement systems in the U.S. (as part of the PPACA) or abroad (for example, those under consideration in France, Germany, Italy and the United Kingdom) could significantly reduce reimbursement for our customers products, which could in turn reduce the demand for our products.

Moreover, in the coming years, additional changes could be made to governmental healthcare programs that could significantly impact the success of our products. We will continue to evaluate the PPACA, as amended, the implementation of regulations or guidance related to various provisions of the PPACA by federal agencies, as well as trends and changes that may be encouraged by the legislation and that may potentially impact our business over time.

No assurance can be given that we will continue to pay or declare dividends.

We have historically paid dividends. However, there can be no assurance that we will pay or declare dividends in the future. The actual declaration and payment of future dividends, the amount of any such dividends, and the establishment of record and payment dates, if any, are subject to determination by our Board of Directors each quarter after its review of our then-current strategy, applicable debt covenants and financial performance and position, among other things. Our declaration and payment of future dividends is subject to risks and uncertainties, including: deterioration of our financial performance or position; inability to declare a dividend in compliance with applicable laws or debt covenants; an increase in our cash needs or decrease in available cash; and the business judgment of the Board of Directors that a declaration of a dividend is not in the Company's best interests.

Our results of operations and earnings may not meet guidance or expectations.

We provide public guidance on our expected results of operations for future periods. This guidance is comprised of forward-looking statements subject to risks and uncertainties, including the risks and uncertainties described in this Form 10-K and in our other public filings and public statements, and is based necessarily on assumptions we make at the time we provide such guidance. Our guidance may not always be accurate. If, in the future, our results of operations for a particular period do not meet our guidance or the expectations of investment analysts or if we reduce our guidance for future periods, the market price of our common stock could decline significantly.

We are exposed to credit risk on accounts receivable and certain prepayments made in the normal course of business. This risk is heightened during periods when economic conditions worsen.

A substantial majority of our outstanding trade receivables are not covered by collateral or credit insurance. In addition, we have made prepayments associated with insurance premiums and other advances in the normal course of business. While we have procedures to monitor and limit exposure to credit risk on trade receivables and other current assets, there can be no assurance such procedures will effectively limit our credit risk and avoid losses, which could have a material adverse effect on our financial condition and operating results.


15



Unauthorized access to our or our customers' information and systems could negatively impact our business.

We may face certain security threats, including threats to the confidentiality, availability and integrity of our data and systems. We maintain an extensive network of technical security controls, policy enforcement mechanisms and monitoring systems in order to address these threats. While these measures are designed to prevent, detect and respond to unauthorized activity in our systems, certain types of attacks could result in financial or information losses and/or reputational harm. If we cannot prevent the unauthorized access, release and/or corruption of our or our customers' confidential, classified or personally identifiable information, our reputation could be damaged, and/or we could face financial losses.

If we fail to comply with our obligations under our distributorship or license agreements with Daikyo or we are unable to renew these agreements on the same or substantially similar terms, we could lose license rights that are important to our business.

Key value-added and proprietary products and processes are licensed from our affiliate, Daikyo, including but not limited to Daikyo CZ, FluroTec and B2-coating technologies. Our rights to these products and processes are licensed pursuant to agreements that expire in 2017, which we expect to renew prior to their expiration. However, if we are unsuccessful in renewing these agreements, or if the agreements are terminated early because we fail to satisfy our obligations, our business could be adversely impacted.

ITEM IB. UNRESOLVED STAFF COMMENTS

As of the filing of this Form 10-K, there were no unresolved comments from the Staff of the SEC.

16




ITEM 2. PROPERTIES

Our corporate headquarters are located at 530 Herman O. West Drive, Exton, Pennsylvania. This building also houses our North American sales and marketing, administrative support and customer service functions, as well as laboratories.

The following table summarizes production facilities by segment and geographic region. All facilities shown are owned except where otherwise noted.

Packaging Systems
Manufacturing:
 
 
 
 
North American Operations
 
European Operations
 
Asia Pacific Operations
United States
 
Denmark
 
China
Clearwater, FL
 
Horsens
 
Qingpu
Jersey Shore, PA
 
England
 
India
Kearney, NE
 
St. Austell
 
Sri City
Kinston, NC
 
France
 
Singapore
Lititz, PA
 
Le Nouvion
 
Jurong
St. Petersburg, FL (1)
 
Germany
 
 
 
 
Eschweiler (1)
 
 
South American Operations
 
Stolberg
 
 
Brazil
 
Serbia
 
 
Sao Paulo
 
Kovin
 
 
 
 
 
 
 
Mold-and-Die Tool Shop:
 
 
 
Contract Analytical Laboratory:
North American Operations
 
European Operations
 
North American Operations
United States
 
England
 
United States
Upper Darby, PA
 
Bodmin (2)
 
Exton, PA
 
 
 
 
 
Delivery Systems
Manufacturing:
 
 
 
 
North American Operations
 
European Operations
 
 
United States
 
France
 
 
Frankford, IN (2)
 
Le Vaudreuil (2)
 
 
Grand Rapids, MI
 
Ireland
 
 
Phoenix, AZ (2)
 
Dublin (2)
 
 
Scottsdale, AZ (2)(3)
 
 
 
 
Tempe, AZ (2)
 
 
 
 
Williamsport, PA
 
 
 
 
Puerto Rico
 
 
 
 
Cayey
 
 
 
 
 
 
 
 
 

(1)
This manufacturing facility is also used for research and development activities.
(2)
This facility is leased in whole or in part.
(3)
This manufacturing facility is also used for mold and die production.


17



Our Delivery Systems segment leases facilities located in Israel, New Jersey and Texas for research and development, as well as other activities. Sales offices in various locations are leased under short-term arrangements.

In October 2014, we announced plans to expand our global manufacturing operations to include a new facility in Waterford, Ireland, which will produce packaging components for insulin injector cartridges and other high-value packaging components. Construction began in July 2015.

ITEM 3. LEGAL PROCEEDINGS
None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

EXECUTIVE OFFICERS OF THE COMPANY

The executive officers of the Company are set forth in this table. Executive officers are elected by the Board of Directors annually at the regular meeting of the Board of Directors following the Annual Meeting of Shareholders.
Name
Age
Position
Michael A. Anderson
60
Vice President and Treasurer since June 2001. He was Finance Director, Drug Delivery Systems Division from October 1999 to June 2001, Vice President, Business Development from April 1997 to October 1999 and Director of Taxes from July 1992 to April 1997.
 
 
 
Warwick Bedwell
56
President, Pharmaceutical Packaging Systems Asia Pacific Region since January 3, 2011. Previously, he served as Vice President and Commercial Director-Bone and Rheumatology for Roche Products (UK) Limited, a biotech company, from October 2008 to August 2010. From January 2007 to October 2008, he served as Vice President and Global Head of Business Development for Hoffman LaRoche Inc. (U.S.) and from June 2003 to December 2006, he served as President and General Manager of Roche Inc. in the Philippines. Prior thereto, he held numerous positions in commercial operations for Roche Products Pty Ltd. in Australia.
 
 
 
Annette F. Favorite
51
Senior Vice President and Chief Human Resources Officer since October 2015. Prior to joining West, she spent more than 25 years at IBM Corporation, an information technology services company, in a number of strategic and global human resources roles. Most recently, she served as Vice President, Global Talent Management.
 
 
 
William J. Federici

56
Senior Vice President and Chief Financial Officer since joining the Company in August 2003. He was National Industry Director for Pharmaceuticals of KPMG LLP (accounting firm) from June 2002 until August 2003 and, prior thereto, an audit partner with Arthur Andersen, LLP.
 
 
 
Karen A. Flynn
53
President, Pharmaceutical Packaging Systems since October 2014. She was President, Pharmaceutical Packaging Systems Americas Region from June 2012 to October 2014 and served as Vice President, Sales from May 2008 to June 2012. From 2000 to 2008, she worked in Sales Management, most recently as Vice President, Global Accounts, for Catalent (formerly a business segment of Cardinal Health). Prior thereto, she held various positions at West, including Quality, Research and Development, and Sales.

18



Eric M. Green

46
Chief Executive Officer since April 2015 and President since December 2015. Prior to joining West, he was Executive Vice President and President of the Research Markets business unit at Sigma-Aldrich Corporation, a leading life science and technology company, from 2013 to 2015. From 2009 to 2013, he served as Vice President and Managing Director, International, where he was responsible for Asia Pacific and Latin America, and prior thereto, held various commercial and operational roles.
 
 
 
Heino Lennartz


50
President, Pharmaceutical Packaging Systems Europe Region since February 2010 and, prior thereto, President, Europe, Pharmaceutical Systems since July 2009. He was Vice President Finance, MIS & Purchasing for Europe & Asia Pacific from December 2006 until July 2009. Mr. Lennartz was Vice President Corporate Finance of AIXTRON AG, a leading semiconductor equipment company, from 2003 to 2006 and, prior thereto, held various positions, including Director Business Systems Europe, at GDX Automotive, a rubber and plastic car body sealing system supplier.
 
 
 
Daniel Malone

54
Vice President and Corporate Controller since August 2011. He was Vice President of Finance, Pharmaceutical Packaging Systems Americas Region from September 2008 to August 2011 and Director of Financial and Management Reporting from October 1999 to September 2008.
 
 
 
George L. Miller
61
Senior Vice President, General Counsel and Corporate Secretary since joining West in November 2015. Previously, he served as Senior Vice President, General Counsel and Corporate Secretary for Sigma-Aldrich Corporation from 2009 to 2015. Prior to working at Sigma-Aldrich, he held senior legal positions with Novartis AG, a global healthcare company.
 
 
 
John E. Paproski
59
President, Pharmaceutical Delivery Systems since December 2009. He was Vice President of Innovation, from January 2005 to December 2009 and Vice President, Global Product Development from August 1996 to January 2005. He has held numerous other operations and engineering positions within the Company, including Vice President of Rubber Operations from August 1993 to January 2005 and Director of Manufacturing Engineering from 1991 to 1993.
 
 
 
Christopher G. Ryan
55
President, Pharmaceutical Packaging Systems Americas Region since February 2015. Previously, he served as Global Business Leader and Strategic Marketer for the Industrial Product Division at W.L. Gore. Prior to serving in this role, he led a Global Consumer Performance Fabric Business Unit at the same company. Prior thereto, he held various senior positions at Cargill, Inc.



19



PART II

ITEM 5.  MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Our common stock is listed on the New York Stock Exchange under the symbol “WST.” The following table shows the high and low prices for our common stock as reported by the NYSE, for the periods indicated.

 
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
Year
 
High
Low
High
Low
High
Low
High
Low
High
Low
2015
60.30
48.66
60.00
52.73
61.73
53.10
64.59
52.79
64.59
48.66
2014
51.12
41.41
45.73
40.93
45.43
39.11
55.29
43.49
55.29
39.11

As of January 31, 2016, we had 861 shareholders of record, which excludes shareholders whose shares were held by brokerage firms, depositaries and other institutional firms in “street names” for their customers.

Dividends

Our common stock paid a quarterly dividend of $0.10 per share in each of the first three quarters of 2014; $0.11 per share in the fourth quarter of 2014 and each of the first three quarters of 2015; and $0.12 per share in the fourth quarter of 2015.

Issuer Purchases of Equity Securities

The following table shows information with respect to purchases of our common stock made during the three months ended December 31, 2015 by us or any of our “affiliated purchasers” as defined in Rule 10b-18(a)(3) under the Exchange Act:
Period
 
Total number of shares purchased
(1)
 
Average price paid per share
 
Total number of shares purchased as
part of publicly
announced plans or
programs (2)                                                                                                
 
Maximum number
of shares that may
yet be purchased
under the plans or
programs  (2)
October 1 – 31, 2015
 
20

 
$
53.34

 

 

November 1 – 30, 2015
 
220

 
61.55

 

 

December 1 – 31, 2015
 
70

 
61.41

 

 

Total
 
310

 
$
60.99

 

 

(1)
Includes 310 shares purchased on behalf of employees enrolled in the Non-Qualified Deferred Compensation Plan for Designated Employees (Amended and Restated Effective January 1, 2008). Under the plan, Company match contributions are delivered to the plan’s investment administrator, who then purchases shares in the open market and credits the shares to individual plan accounts.
(2)
In December 2015, we announced a share repurchase program authorizing the repurchase of up to 700,000 shares of the Company’s common stock from time to time on the open market or in privately- negotiated transactions as permitted under the Securities Exchange Act of 1934 Rule 10b-18. The number of shares to be repurchased and the timing of such transactions will depend on a variety of factors, including market conditions. The program commenced on January 1, 2016 and is expected to be completed by December 31, 2016. The Company's previously-authorized share repurchase program expired on December 31, 2015.

20




Performance Graph

The following performance graph compares the cumulative total return to holders of our common stock with the cumulative total return of the following Standard & Poor's ("S&P") indices, for the five years ended December 31, 2015: MidCap 400 Index, 400 Health Care Equipment & Supplies Industry, SmallCap 600 Index and 600 Health Care Equipment & Supplies Industry. Due to the appreciation in the Company's share value, the S&P added the Company to its midcap indices in 2015, and removed the Company from their smallcap indices, which were shown in the prior-year Form 10-K.

Cumulative total return to shareholders is measured by dividing total dividends (assuming dividend reinvestment) plus the per-share price change for the period by the share price at the beginning of the period. The Company's cumulative shareholder return is based on an investment of $100 on December 31, 2010 and is compared to the cumulative total return of the S&P indices mentioned above over the period with a like amount invested.



21




ITEM 6. SELECTED FINANCIAL DATA
FIVE-YEAR SUMMARY
West Pharmaceutical Services, Inc. and Subsidiaries

(in millions, except per share data)
2015

2014

2013

2012

2011

SUMMARY OF OPERATIONS
 
 
 
 
 
Net sales
$
1,399.8

$
1,421.4

$
1,368.4

$
1,266.4

$
1,192.3

Operating profit
128.6

182.0

162.4

135.1

109.6

Net income
95.6

127.1

112.3

80.7

75.5

Net income per share:
 
 
 
 
 
Basic (1)
$
1.33

$
1.79

$
1.61

$
1.19

$
1.12

Diluted (2)
1.30

1.75

1.57

1.15

1.08

Weighted average common shares outstanding
72.0

70.9

69.6

68.1

67.3

Weighted average shares assuming dilution
73.8

72.8

71.4

71.8

74.0

Dividends declared per common share
$
0.46

$
0.41

$
0.39

$
0.37

$
0.35

 
 
 
 
 
 
YEAR-END FINANCIAL POSITION
 
 
 
 
 
Cash and cash equivalents
$
274.6

$
255.3

$
230.0

$
161.9

$
91.8

Working capital  †
359.4

406.6

413.6

295.4

228.8

Total assets
1,695.1

1,669.7

1,670.2

1,562.5

1,398.7

Total invested capital:
 
 
 
 
 
Total debt
298.2

335.5

372.1

410.0

349.0

Total equity
1,023.9

956.9

906.4

728.9

654.9

Total invested capital
$
1,322.1

$
1,292.4

$
1,278.5

$
1,138.9

$
1,003.9

 
 
 
 
 
 
PERFORMANCE MEASUREMENTS (3)
 
 
 
 
 
Gross margin (a)
32.6
%
31.5
%
31.8
%
30.6
%
28.5
%
Operating profitability (b)
9.2
%
12.8
%
11.9
%
10.7
%
9.2
%
Effective tax rate
22.6
%
28.0
%
27.4
%
30.2
%
25.3
%
Return on invested capital (c)
7.6
%
10.2
%
9.8
%
8.8
%
8.2
%
Net debt-to-total invested capital (d)
2.3
%
7.7
%
13.6
%
25.4
%
28.2
%
Research and development expenses
$
34.1

$
37.3

$
37.9

$
33.2

$
29.1

Operating cash flow
212.4

182.9

220.5

187.4

130.7

Stock price range
$64.59-48.66

$55.29-39.11

$50.60-27.31

$28.01-18.68

$23.98-17.75


(1) Based on weighted average common shares outstanding.

(2) Based on weighted average shares, assuming dilution.

(3) Performance measurements represent indicators commonly used in the financial community. The following performance measures are not in conformity with U.S. generally accepted accounting principles ("U.S. GAAP") and should not be used as a substitute for the comparable U.S. GAAP financial measures. The non-U.S. GAAP financial measures are included as management uses them in evaluating our results of operations, and believes that this information provides users a valuable insight into our overall performance and financial position.

(a) Net sales minus cost of goods and services sold, including applicable depreciation and amortization, divided by net sales.
(b) Operating profit divided by net sales.
(c) Operating profit multiplied by one minus the effective tax rate divided by average total invested capital.
(d) Net debt (total debt less cash and cash equivalents) divided by total invested capital less cash and cash equivalents.

22



Reflects the Company's adoption of the guidance issued by the Financial Accounting Standards Board ("FASB") in 2015 regarding the classification of debt issuance costs.

Factors affecting the comparability of the information reflected in the selected financial data:

Net income in 2015 included the impact of a pension settlement charge of $32.0 million (net of $18.4 million in tax), a charge for executive retirement and related costs of $6.9 million (net of $4.0 million in tax) and a discrete tax charge of $0.8 million.

Net income in 2014 included the impact of a charge for license costs associated with acquired in-process research of $0.8 million (net of $0.4 million in tax) and discrete tax charges of $1.8 million.

Net income in 2013 included the impact of a loss on extinguishment of debt of $0.2 million and net discrete tax charges of $3.6 million.

Net income in 2012 included the impact of restructuring and related charges of $1.4 million (net of $0.7 million in tax), an impairment charge of $2.1 million (net of $1.3 million in tax), an increase in acquisition-related contingencies of $1.0 million (net of $0.2 million in tax), a loss on extinguishment of debt of $9.8 million (net of $1.8 million in tax) and discrete tax charges of $2.1 million.

Net income in 2011 included the impact of restructuring and related charges of $3.5 million (net of $1.8 million in tax), income from the reduction of acquisition-related contingencies of $0.2 million, special separation benefits related to the retirement of our former President and Chief Operating Officer of $1.8 million (net of $1.1 million in tax) and net discrete tax charges of $1.4 million.


23




ITEM 7.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

OVERVIEW

The following discussion is intended to further the reader's understanding of the consolidated financial condition and results of operations of our Company. It should be read in conjunction with our consolidated financial statements and the accompanying footnotes included in Part II, Item 8 of this Form 10-K. These historical financial statements may not be indicative of our future performance. This Management's Discussion and Analysis of Financial Condition and Results of Operations contains a number of forward-looking statements, all of which are based on our current expectations and could be affected by the uncertainties and risks discussed in Part I, Item 1A of this Form 10-K.

Throughout this section, references to “Notes” refer to the footnotes included in Part II, Item 8 of this Form 10-K, unless otherwise indicated.

Non-U.S. GAAP Financial Measures

For the purpose of aiding the comparison of our year-over-year results, we may refer to net sales and other financial results excluding the effects of changes in foreign currency exchange rates. The constant-currency amounts are calculated by translating the current year’s functional currency results at the prior-year period’s exchange rate. We may also refer to consolidated operating profit and consolidated operating profit margin excluding the effects of unallocated items. The re-measured results excluding effects from currency translation and excluding the effects of unallocated items are not in conformity with U.S. GAAP and should not be used as a substitute for the comparable U.S. GAAP financial measures. The non-U.S. GAAP financial measures are incorporated into our discussion and analysis as management uses them in evaluating our results of operations, and believes that this information provides users a valuable insight into our results.

Our Operations

We are a manufacturer of components and systems for the packaging and delivery of injectable drugs as well as components for the pharmaceutical, healthcare and consumer products industries. Our products include stoppers and seals for vials, prefillable syringe components and systems, components for intravenous and blood collection systems, safety and administration systems, advanced injection systems, and contract design and manufacturing services. Our customers include the leading global producers of pharmaceuticals, biologics, medical devices and consumer products. We were incorporated under the laws of the Commonwealth of Pennsylvania on July 27, 1923.

Our business operations are organized into two reportable segments, Packaging Systems and Delivery Systems. Packaging Systems develops, manufactures and sells primary packaging components and systems for injectable drug delivery, including stoppers and seals for vials, closures and other components used in syringe, intravenous and blood collection systems, and prefillable syringe components. Delivery Systems develops, manufactures and sells safety and administration systems, multi-component systems for drug administration, and a variety of custom contract-manufacturing solutions targeted to the healthcare and consumer-products industries. In addition, Delivery Systems is responsible for the continued development and commercialization of our line of proprietary, multi-component systems for injectable drug administration and other healthcare applications. We also maintain global partnerships to share technologies and market products with affiliates in Japan and Mexico.


24



Our 2015 results were affected by the weakening of the Euro and other foreign currencies in relation to USD. As a result of our global manufacturing and distribution presence, more than half of our revenues are generated outside of the U.S. in currencies other than USD, including approximately 40% in Europe and 10% collectively in Asia and South America. Fluctuations in foreign currency exchange rates, therefore, can have a significant effect on our consolidated financial results. Generally, our financial results are affected positively by a weaker USD and negatively by a stronger USD, as compared to the foreign currencies in which we conduct our business. In terms of net sales, the most significant foreign currencies are the Euro, the Singapore Dollar, and the Danish Krone, with Euro-denominated sales representing the majority of sales transacted in foreign currencies. In addition, we are exposed to Yen, as we maintain a 25% ownership interest in, and we purchase finished goods and other materials from, Daikyo. During 2015, average exchange rates were unfavorable versus the exchange rates realized in 2014, resulting in lower reported net sales, operating profit, net income, and net income per diluted share of $123.9 million, $29.3 million, $21.4 million, and $0.29, respectively, as compared to 2014. The average Euro to USD exchange rate decreased from $1.33 for 2014 to $1.11 for 2015.

Our 2015 results also include a $50.4 million pension settlement charge, which reduced net income and net income per diluted share by $32.0 million and $0.43, respectively, as compared to 2014, a $10.9 million charge for executive retirement and related costs, which lowered net income and net income per diluted share by $6.9 million and $0.09, respectively, as compared to 2014, and a discrete tax charge of $0.8 million, which reduced net income and net income per diluted share by $0.8 million and $0.01, respectively, compared to 2014.

Excluding foreign currency effects, the pension settlement charge, the executive retirement charge, and the discrete tax charge, our net sales and net income per diluted share increased by 7.2% and 21.1%, respectively, for 2015, as compared to 2014. At December 31, 2015, our cash and cash equivalents balance totaled $274.6 million and our borrowing capacity under our senior unsecured, multi-currency revolving credit facility agreement (the "New Credit Agreement") was $269.9 million. The New Credit Agreement expires in October 2020.

2016 Organizational Structure Change and Business Outlook

In 2015, our business operations consisted of two reportable segments, as discussed above. Beginning in 2016, we are changing our organization and reporting structure for our next phase of growth and development, which will result in a change to Proprietary Products and Contract-Manufactured Products as reportable segments. See Part I, Item 1, Business, of this Form 10-K for further discussion regarding the change in our organization and reporting structure.

We continue to focus on our customers' increasing demand for higher product quality, including the development of our proprietary packaging and delivery systems product offerings. We will manage our capabilities and asset base to respond to changing markets and to enable improvements in service and quality. We expect that contract manufacturing will remain focused on pharmaceutical and medical device customers. We plan to continue funding capital projects related to new products, expansion activity, advanced quality systems, and investment in emerging markets. We believe that our strong operating results and financial position give us a platform for sustained growth, and will enable us to take advantage of opportunities to invest in our business as they arise. See Part I, Item 1A, Risk Factors, of this Form 10-K for further discussion regarding the risks associated with our operations.

On February 17, 2016, the Venezuelan government announced a devaluation of the Bolivar, from the official exchange rate of 6.3 Bolivars to USD to 10.0 Bolivars to USD, and streamlined the previous three-tiered currency exchange mechanism into a dual currency exchange mechanism. Please refer to Note 18, Subsequent Events, for further discussion.

25




RESULTS OF OPERATIONS

We evaluate the performance of our segments based upon, among other things, segment net sales and operating profit. Segment operating profit excludes general corporate costs, which include executive and director compensation, stock-based compensation, adjustments to annual incentive plan expense for over- or under-attainment of targets, certain pension and other retirement benefit costs, and other corporate facilities and administrative expenses not allocated to the segments. Also excluded are items that management considers not representative of ongoing operations. Such items are referred to as other unallocated items and generally include restructuring and related charges, certain asset impairments and other specifically-identified income or expense items.

Percentages in the following tables and throughout this Results of Operations section may reflect rounding adjustments.

Net Sales

The following table presents net sales, consolidated and by reportable segment:

 
Year Ended December 31,
 
% Change
($ in millions)
2015
 
2014
 
2013
 
2015/2014
 
2014/2013
Packaging Systems
$
1,000.7

 
$
1,019.7

 
$
996.0

 
(1.9
)%
 
2.4
%
Delivery Systems
400.2

 
402.5

 
374.1

 
(0.5
)%
 
7.6
%
Intersegment sales elimination
(1.1
)
 
(0.8
)
 
(1.7
)
 

 

Consolidated net sales
$
1,399.8

 
$
1,421.4

 
$
1,368.4

 
(1.5
)%
 
3.9
%

2015 compared to 2014
Consolidated net sales decreased by $21.6 million, or 1.5%, in 2015, including an unfavorable foreign currency impact of $123.9 million. Excluding foreign currency effects, consolidated net sales increased by $102.3 million, or 7.2%. Consolidated net sales originating in the U.S. in 2015 were $667.4 million, an increase of 5.8% from 2014. Consolidated net sales generated outside of the U.S. (mainly in Europe) in 2015 were $732.4 million, a decrease of 7.4% from 2014 due to an unfavorable foreign currency impact. Excluding foreign currency effects, consolidated net sales generated outside of the U.S. in 2015 increased by 8.3%.

Packaging Systems – Packaging Systems' net sales decreased by $19.0 million, or 1.9%, in 2015, including an unfavorable foreign currency impact of $105.2 million. Excluding foreign currency effects, net sales increased by $86.2 million, or 8.5%, due to growth in our high-value product offerings, particularly FluroTec-coated components, Westar components, and the Envision line of vision-inspected components. An improvement in product mix and higher sales volumes contributed 6.9 percentage points of the increase, and sales price increases contributed the remainder of the increase. Our high-value product offerings represented 46.0% of Packaging Systems' net sales in 2015, as compared to 43.6% in 2014.

Delivery Systems – Delivery Systems' net sales decreased by $2.3 million, or 0.5%, in 2015, including an unfavorable foreign currency impact of $18.7 million. Excluding foreign currency effects, net sales increased by $16.4 million, or 4.1%, due to an increase in contract manufacturing sales, particularly sales of glucose monitoring devices. Sales volumes contributed the entirety of the increase. Proprietary net sales represented 24.7% of Delivery Systems' net sales in 2015, as compared to 26.2% in 2014, as net sales for SmartDose were higher in 2014 due to clinical trials that have since concluded.


26



2014 compared to 2013
Consolidated net sales increased by $53.0 million, or 3.9%, in 2014, despite an unfavorable foreign currency impact of $5.5 million. Excluding foreign currency effects, consolidated net sales increased by $58.5 million, or 4.3%.

Packaging Systems – Packaging Systems’ net sales increased by $23.7 million, or 2.4%, in 2014, despite an unfavorable foreign currency impact of $5.7 million. Excluding foreign currency effects, net sales increased by $29.4 million, or 2.9%. While overall growth in our high-value product offerings continued, customer inventory management actions due to regulatory issues and formulation changes reduced demand levels for Teflon and FluroTec-coated components, resulting in a reduction in sales of these products in 2014. Our high-value product offerings represented 43.2% of Packaging Systems' net sales for 2014, as compared to 42.9% in 2013. Higher sales volumes and a moderate improvement in product mix contributed 2.1 percentage points of the increase, and sales price increases contributed 0.8 percentage points of the increase.

Delivery Systems – Delivery Systems’ net sales increased by $28.4 million, or 7.6%, in 2014, including a favorable foreign currency impact of $0.2 million. Excluding foreign currency effects, net sales increased by $28.2 million, or 7.5%, primarily due to an increase in contract manufacturing sales, proprietary reconstitution product sales, and customer-funded clinical development sales of our SmartDose component samples. Proprietary net sales represented 26.2% of Delivery Systems' net sales for 2014, as compared to 24.8% in 2013. Sales volume and product mix improvements contributed 7.1 percentage points of the increase, and sales price increases contributed the remainder of the increase.

The intersegment sales elimination, which is required for the presentation of consolidated net sales, represents the elimination of components sold between our segments.

Gross Profit

The following table presents gross profit and related gross margins, consolidated and by reportable segment:

 
Year Ended December 31,
 
% Change
($ in millions)
2015
 
2014
 
2013
 
2015/2014
 
2014/2013
Packaging Systems:
 
 
 
 
 
 
 
 
 
Gross Profit
$
381.7

 
$
369.0

 
$
361.4

 
3.4
 %
 
2.1
%
Gross Margin
38.1
%
 
36.2
%
 
36.3
%
 
 
 
 
Delivery Systems:
 
 
 

 
 

 
 

 
 

Gross Profit
$
74.1

 
$
78.8

 
$
73.3

 
(6.0
)%
 
7.5
%
Gross Margin
18.5
%
 
19.6
%
 
19.6
%
 
 
 
 
Consolidated Gross Profit
$
455.8

 
$
447.8

 
$
434.7

 
1.8
 %
 
3.0
%
Consolidated Gross Margin
32.6
%
 
31.5
%
 
31.8
%
 
 
 
 

2015 compared to 2014
Consolidated gross profit increased by $8.0 million, or 1.8%, in 2015, despite an unfavorable foreign currency impact of $42.4 million. Consolidated gross margin increased by 1.1 margin points in 2015.

Packaging Systems – Packaging Systems' gross profit increased by $12.7 million, or 3.4%, in 2015, despite an unfavorable foreign currency impact of $37.1 million. Packaging Systems' gross margin increased by 1.9 margin points in 2015, as product mix improvements, sales price increases, and production efficiencies were partially offset by increased labor and overhead costs.


27



Delivery Systems –Delivery Systems' gross profit decreased by $4.7 million, or 6.0%, in 2015, including an unfavorable foreign currency impact of $5.3 million. Delivery Systems' gross margin decreased by 1.1 margin points in 2015, as a result of increased overhead and depreciation related to new capabilities supporting both proprietary and contract manufacturing programs.

2014 compared to 2013
Consolidated gross profit increased by $13.1 million, or 3.0%, in 2014, despite an unfavorable foreign currency impact of $2.3 million. Consolidated gross margin decreased by 0.3 margin points in 2014.

Packaging Systems – Packaging Systems’ gross profit increased by $7.6 million, or 2.1%, in 2014, despite an unfavorable foreign currency impact of $2.3 million. Packaging Systems' gross margin decreased by 0.1 margin points in 2014, as lower raw material costs and moderate sales price and product mix improvements were offset by increased employee compensation, laboratory and engineering costs.

Delivery Systems – Delivery Systems’ gross profit increased by $5.5 million, or 7.5%, in 2014. Delivery Systems’ gross margin remained constant at 19.6%, as margin improvements from the increased proportion of proprietary products sold were offset by higher depreciation and overhead costs for these programs, as well as start-up costs on new contract manufacturing products.

Research and Development (“R&D”) Costs

The following table presents R&D costs, consolidated and by reportable segment:

 
Year Ended December 31,
 
% Change
($ in millions)
2015
 
2014
 
2013
 
2015/2014
 
2014/2013
Packaging Systems
$
14.4

 
$
16.3

 
$
15.1

 
(11.7
)%
 
7.9
 %
Delivery Systems
19.7

 
21.0

 
22.8

 
(6.2
)%
 
(7.9
)%
Consolidated R&D costs
$
34.1

 
$
37.3

 
$
37.9

 
(8.6
)%
 
(1.6
)%

2015 compared to 2014
Consolidated R&D costs decreased by $3.2 million, or 8.6%, in 2015, including the impact of foreign currency, which decreased R&D costs by $1.0 million.

Packaging Systems – Packaging Systems' R&D costs decreased by $1.9 million, or 11.7%, in 2015, primarily due to the reallocation of resources to commercial projects in 2015 and the impact of foreign currency, which decreased R&D costs by $0.8 million.

Delivery Systems – Delivery Systems' R&D costs decreased by $1.3 million, or 6.2%, in 2015, due to the reassignment of personnel to clinical trial production activities for SmartDose in 2015, the completion of development work on the SelfDose self-injection system in 2014, and the impact of foreign currency, which decreased R&D costs by $0.2 million. Efforts remain focused on the further development of SmartDose and CZ products.

2014 compared to 2013
Consolidated R&D costs decreased by $0.6 million, or 1.6%, in 2014.

Packaging Systems – Packaging Systems' R&D costs increased by $1.2 million, or 7.9%, in 2014, as a result of continued investment in next-generation packaging components.

Delivery Systems – Delivery Systems' R&D costs decreased by $1.8 million, or 7.9%, in 2014, primarily due to the reassignment of personnel to clinical trial production activities for SmartDose.


28



Selling, General and Administrative (“SG&A”) Costs

The following table presents SG&A costs, consolidated and by reportable segment and corporate:

 
Year Ended December 31,
 
% Change
($ in millions)
2015
 
2014
 
2013
 
2015/2014
 
2014/2013
Packaging Systems
$
132.7

 
$
130.1

 
$
128.4

 
2.0
 %
 
1.3
 %
Delivery Systems
42.5

 
45.4

 
42.6

 
(6.4
)%
 
6.6
 %
Corporate
57.8

 
53.2

 
63.9

 
8.6
 %
 
(16.7
)%
Consolidated SG&A costs
$
233.0

 
$
228.7

 
$
234.9

 
1.9
 %
 
(2.6
)%
SG&A as a % of net sales
16.6
%
 
16.1
%
 
17.2
%
 
 
 
 

2015 compared to 2014
Consolidated SG&A costs increased by $4.3 million, or 1.9%, in 2015, despite the impact of foreign currency, which decreased SG&A costs by $12.5 million. Consolidated SG&A cost for 2015 and 2014 were 16.6% and 16.1%, respectively, of consolidated net sales for 2015 and 2014.

Packaging Systems – Packaging Systems' SG&A costs increased by $2.6 million, or 2.0%, in 2015, as increases in compensation costs related to merit increases, incentive compensation costs, and consulting and sales costs were partially offset by the impact of foreign currency, which decreased SG&A costs by $11.3 million.

Delivery Systems – Delivery Systems' SG&A costs decreased by $2.9 million, or 6.4%, in 2015, as decreases in sales costs and the impact of foreign currency, which decreased SG&A costs by $1.2 million, were partially offset by increases in incentive compensation costs, compensation costs, and depreciation expense.

Corporate – Corporate’s SG&A costs increased by $4.6 million, or 8.6%, in 2015, due to increased incentive compensation costs and stock-based compensation expense, both of which were partially offset by decreases in U.S. pension costs and outside services.

2014 compared to 2013
Consolidated SG&A costs decreased by $6.2 million, or 2.6%, in 2014, including the impact of foreign currency, which decreased SG&A costs by $0.9 million. Consolidated SG&A costs for 2014 and 2013 were 16.1% and 17.2%, respectively, of consolidated net sales for 2014 and 2013.

Packaging Systems – Packaging Systems' SG&A costs increased by $1.7 million, or 1.3%, in 2014, as a result of increased compensation costs for wage increases and additional marketing and sales personnel in Asia, partially offset by a decrease in consulting costs and foreign currency effects.

Delivery Systems – Delivery Systems' SG&A costs increased by $2.8 million, or 6.6%, in 2014, as a result of incremental business development costs and depreciation and amortization expense.

Corporate – Corporate's SG&A costs decreased by $10.7 million, or 16.7%, in 2014, due to a decrease in U.S. pension expense mostly resulting from the amortization of actuarial gains and losses and a decrease in incentive compensation costs.


29



Other Expense (Income)

The following table presents other income and expense items, consolidated and by reportable segment and unallocated items:

(Income) expense
Year Ended December 31,
($ in millions)
2015
 
2014
 
2013
Packaging Systems
$
(1.1
)
 
$
(0.4
)
 
$
0.9

Delivery Systems
(0.1
)
 
(1.1
)
 
(1.5
)
Corporate

 
0.1

 
0.1

Unallocated items
61.3

 
1.2

 

Consolidated other expense (income)
$
60.1

 
$
(0.2
)

$
(0.5
)

Other income and expense items, consisting of foreign exchange transaction gains and losses, gains and losses on the sale of fixed assets, development income, contingent consideration costs, and miscellaneous income and charges, are generally recorded within segment results.

2015 compared to 2014
Consolidated other expense (income) changed by $60.3 million in 2015.

Packaging Systems – Packaging Systems' other income increased by $0.7 million in 2015, primarily due to an asset write-off recorded in 2014.

Delivery Systems – Delivery Systems' other income decreased by $1.0 million in 2015, due to gains recorded in 2014, including a gain recorded as a result of the sale of a contract services business, and an increase in foreign exchange transaction losses.

Corporate – Corporate other expense decreased by $0.1 million to zero in 2015.

Unallocated items – During 2015, we recorded a $50.4 million pension settlement charge, of which $47.0 million related to our purchase of a group annuity contract from Metropolitan Life Insurance Company ("MetLife") to settle $139.4 million of our $313.6 million outstanding pension benefit obligations under our U.S. qualified pension plan. MetLife assumed the obligation to pay future pension benefits and provide administrative services beginning November 1, 2015 for approximately 1,750 retirees and surviving beneficiaries who retired before January 1, 2015 and are currently receiving payments from this plan. The purchase was funded directly by plan assets. The remaining portion of the pension settlement charge related to lump-sum payouts made to terminated vested participants of our U.S. qualified pension plan. In addition, during 2015, we recorded a $10.9 million charge for executive retirement and related costs, including $2.4 million for a long-term incentive plan award for our previous Chief Executive Officer ("CEO"), $8.0 million for the revaluation of modified outstanding awards to provide for continued vesting for our previous CEO and Senior Vice President of Human Resources in conjunction with their retirement, and $0.5 million for other costs, including relocation and legal fees.

2014 compared to 2013
Consolidated other income decreased by $0.3 million in 2014.

Packaging Systems – Packaging Systems' other (income) expense changed by $1.3 million in 2014, due to foreign exchange transaction gains, partially offset by an increase in losses on miscellaneous fixed asset disposals.

Delivery Systems – Delivery Systems' other income decreased by $0.4 million in 2014, due to foreign exchange transaction losses and a decrease in development income, partially offset by an increase in gains on miscellaneous fixed asset disposals.

30




Corporate – Corporate other expense remained constant at $0.1 million in 2014.

Unallocated items – During 2014, we recorded a $1.2 million charge for license costs associated with acquired in-process research.

Operating Profit

The following table presents adjusted operating profit (loss), consolidated and by reportable segment, corporate and unallocated items:

 
Year Ended December 31,
 
% Change
($ in millions)
2015
 
2014
 
2013
 
2015/2014
 
2014/2013
Packaging Systems
$
235.7

 
$
223.0

 
$
217.0

 
5.7
 %
 
2.8
 %
Delivery Systems
12.0

 
13.5

 
9.4

 
(11.1
)%
 
43.6
 %
Corporate
(57.8
)
 
(53.3
)
 
(64.0
)
 
8.4
 %
 
(16.7
)%
Adjusted consolidated operating profit
$
189.9

 
$
183.2

 
$
162.4

 
3.7
 %
 
12.8
 %
Adjusted consolidated operating profit margin
13.6
%
 
12.9
%
 
11.9
%
 
 
 
 
Unallocated items
(61.3
)
 
(1.2
)
 

 
 
 
 
Consolidated operating profit
$
128.6

 
$
182.0

 
$
162.4

 
(29.3
)%
 
12.1
 %
Consolidated operating profit margin
9.2
%
 
12.8
%
 
11.9
%
 
 
 
 

2015 compared to 2014
Consolidated operating profit decreased by $53.4 million, or 29.3%, in 2015, mostly due to a $50.4 million pension settlement charge, a $10.9 million charge for executive retirement and related costs, and an unfavorable foreign currency impact of $29.3 million. Consolidated operating profit margin decreased by 3.6 margin points in 2015.

Packaging Systems – Packaging Systems’ operating profit increased by $12.7 million, or 5.7%, in 2015, despite an unfavorable foreign currency impact of $25.5 million, due to the factors described above.

Delivery Systems – Delivery Systems’ operating profit decreased by $1.5 million, or 11.1%, in 2015, including an unfavorable foreign currency impact of $3.8 million, due to the factors described above.

Corporate – Corporate costs increased by $4.5 million, or 8.4%, in 2015, due to the factors described above.

Unallocated items – Please refer to the Other Expense (Income) section for details.

2014 compared to 2013
Consolidated operating profit increased by $19.6 million, or 12.1%, in 2014, despite an unfavorable foreign currency impact of $1.4 million. Consolidated operating profit margin increased by 0.9 margin points in 2014.

Packaging Systems – Packaging Systems’ operating profit increased by $6.0 million, or 2.8%, in 2014, despite an unfavorable foreign currency impact of $1.4 million, due to the factors described above.

Delivery Systems – Delivery Systems’ operating profit increased by $4.1 million, or 43.6%, in 2014, due to the factors described above.

Corporate – Corporate costs decreased by $10.7 million, or 16.7%, in 2014, due to the factors described above.

Unallocated items – Please refer to the Other Expense (Income) section for details.

31



Loss on Debt Extinguishment

During the year ended December 31, 2014, we repurchased the remaining $0.6 million in aggregate principal amount of our 4.00% Convertible Junior Subordinated Debentures due March 15, 2047 (the "Convertible Debentures"), resulting in a pre-tax loss on debt extinguishment of less than $0.1 million.

During the year ended December 31, 2013, we repurchased $2.5 million in aggregate principal amount of our Convertible Debentures, resulting in a pre-tax loss on debt extinguishment of $0.2 million, the majority of which consisted of the premium over par value.

Interest Expense, Net

The following table presents interest expense, net, by significant component:

 
Year Ended December 31,
 
% Change
($ in millions)
2015
 
2014
 
2013
 
2015/2014
 
2014/2013
Interest expense
$
15.6

 
$
18.1

 
$
18.6

 
(13.8
)%
 
(2.7
)%
Capitalized interest
(1.5
)
 
(1.6
)
 
(1.6
)
 
(6.3
)%
 
 %
Interest income
(1.6
)
 
(3.5
)
 
(1.9
)
 
(54.3
)%
 
84.2
 %
Interest expense, net
$
12.5

 
$
13.0


$
15.1

 
(3.8
)%
 
(13.9
)%

2015 compared to 2014
Interest expense, net, decreased by 0.5 million, or 3.8%, in 2015, primarily due to lower interest expense resulting from less debt outstanding during 2015, partially offset by a decrease in interest income. During 2014, we recorded $1.6 million in interest income following the settlement of a tax matter in Brazil.

2014 compared to 2013
Interest expense, net, decreased by $2.1 million, or 13.9%, in 2014, primarily due to $1.6 million in interest income following the settlement of a tax matter in Brazil and lower interest expense resulting from less debt outstanding during 2014.

Income Taxes

The provision for income taxes was $26.3 million, $47.2 million, and $40.2 million for the years 2015, 2014, and 2013, respectively, resulting in effective tax rates of 22.6%, 28.0%, and 27.4%, respectively.

The decrease in the effective tax rate for 2015 reflects the impact of a tax benefit of $18.4 million in connection with a $50.4 million pension settlement charge and a tax benefit of $4.0 million in connection with a $10.9 million charge for executive retirement and related costs, partially offset by the impact of unfavorable changes in our geographic mix of earnings. In addition, during 2015, we recorded a discrete tax charge of $0.8 million resulting from the impact of a change in the enacted tax rate in the United Kingdom on our previously-recorded deferred tax asset balances.

The increase in the effective tax rate for 2014 reflects changes in our geographic mix of earnings and the impact of a discrete tax charge of $1.0 million resulting from the impact of a change in apportionment factors on state tax rates applied to items in other comprehensive income and a discrete tax charge of $0.8 million as a result of the finalization of estimates of foreign tax credits available with respect to a repatriation of cash from our subsidiaries in Israel.


32



During 2013, we recorded a discrete tax charge of $3.5 million, which related to the finalization of a beneficial agreement with local tax authorities in Israel that clarified the future tax status of our entities in Israel and settled a tax audit for the years 2009 through 2011. During 2013, we also recorded a discrete tax charge of $1.3 million resulting from the impact of the change in the enacted tax rate in the United Kingdom on our previously-recorded deferred tax asset balances and a discrete tax benefit of $1.3 million related to the Research and Development tax credit for activities completed in 2012. In accordance with U.S. GAAP, although the American Taxpayer Relief Act of 2012 (the "Taxpayer Relief Act") reinstated the tax credit on a retroactive basis to January 1, 2012, the credit was not taken into account for financial reporting purposes until 2013.

As of December 31, 2015, we had $5.9 million of total gross unrecognized tax benefits, all of which, if recognized, would favorably impact the effective income tax rate. It is reasonably possible that, due to the expiration of statutes and the closing of tax audits, the liability for unrecognized tax benefits may be reduced by approximately $1.0 million during the next twelve months, which would favorably impact our effective tax rate.

Equity in Net Income of Affiliated Companies

Equity in net income of affiliated companies represents the contribution to earnings from our 25% ownership interest in Daikyo and our 49% ownership interest in four companies in Mexico. Equity in net income of affiliated companies was $5.8 million, $5.3 million, and $5.4 million for the years 2015, 2014 and 2013, respectively. Equity in net income of affiliated companies increased by $0.5 million, or 9.4%, in 2015, as favorable operating results in Mexico were partially offset by unfavorable operating results at Daikyo. Equity in net income of affiliated companies decreased by $0.1 million, or 1.9%, in 2014, as an unfavorable foreign currency impact on Daikyo's results was partially offset by favorable operating results in Mexico.

Purchases from, and royalty payments made to, affiliates totaled $65.8 million in 2015, $68.9 million in 2014, and $74.5 million in 2013, the majority of which related to a distributorship agreement with Daikyo that allows us to purchase and re-sell Daikyo products. Sales to affiliates were $5.3 million, $5.1 million, and $5.9 million in 2015, 2014, and 2013, respectively.

Net Income

Net income in 2015 was $95.6 million, or $1.30 per diluted share, compared to $127.1 million, or $1.75 per diluted share, in 2014. Our 2015 results included the impact of a pension settlement charge of $32.0 million (net of $18.4 million in tax), a charge for executive retirement and related costs of $6.9 million (net of $4.0 million in tax) and a discrete tax charge of $0.8 million.

Net income in 2014 was $127.1 million, or $1.75 per diluted share, compared to $112.3 million, or $1.57 per diluted share, in 2013. Our 2014 results included the impact of a charge for license costs associated with acquired in-process research of $0.8 million (net of $0.4 million in tax) and discrete tax charges of $1.8 million.

Net income in 2013 was $112.3 million, or $1.57 per diluted share, compared to $80.7 million, or $1.15 per diluted share, in 2012. Our 2013 results included the impact of a loss on extinguishment of debt of $0.2 million and net discrete tax charges of $3.6 million.

33




FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES

Cash Flows

The following table presents cash flow data for the years ended December 31:

($ in millions)
2015
 
2014
 
2013
Net cash provided by operating activities
$
212.4

 
$
182.9

 
$
220.5

Net cash used in investing activities
$
(129.5
)
 
$
(104.0
)
 
$
(149.9
)
Net cash used in financing activities
$
(41.5
)
 
$
(30.8
)
 
$
(5.1
)

Net Cash Provided by Operating Activities

2015 compared to 2014
Net cash provided by operating activities increased by $29.5 million in 2015, due to increased earnings before non-cash charges and lower working capital requirements.

2014 compared to 2013
Net cash provided by operating activities decreased by $37.6 million in 2014, due to a $27.2 million increase in pension plan contributions and our receipt of a nonrefundable customer payment of $20.0 million in June 2013 in return for the exclusive use of SmartDose within a specific therapeutic area.

Net Cash Used in Investing Activities

2015 compared to 2014
Net cash used in investing activities increased by $25.5 million in 2015, due to an increase in capital spending, to $131.6 million, and sales and maturities of our remaining short-term investments in 2014. The capital spending for 2015 consisted of spending for new products, expansion activity, and emerging markets, including projects in the U.S., Europe, and Asia.

In October 2014, we announced plans to expand our global manufacturing operations to include a new facility in Waterford, Ireland, which will produce packaging components for insulin injector cartridges and other high-value packaging components. Construction began in July 2015.

2014 compared to 2013
Net cash used in investing activities decreased by $45.9 million in 2014, due to a $40.0 million decrease in capital spending, to $111.9 million, mainly as the construction of our corporate office and research building was completed in February 2013. The majority of the capital spending for 2014 related to new products, expansion activity, and emerging markets, including projects in the U.S., Europe, China and India.

Net Cash Used in Financing Activities

2015 compared to 2014
Net cash used in financing activities increased by $10.7 million in 2015, due to an increase in net debt repayments and dividend payments.

2014 compared to 2013
Net cash used in financing activities increased by $25.7 million in 2014, primarily due to an increase in net repayments of debt and a $7.4 million decrease in proceeds from the exercise of stock options and stock appreciation rights.


34



We paid cash dividends totaling $32.4 million ($0.45 per share) and $29.1 million ($0.41 per share) during 2015 and 2014, respectively.

In December 2015, we announced a share repurchase program authorizing the repurchase of up to 700,000 shares of our common stock from time to time on the open market or in privately-negotiated transactions as permitted under the Securities Exchange Act of 1934 Rule 10b-18. The number of shares to be repurchased and the timing of such transactions will depend on a variety of factors, including market conditions. The program commenced on January 1, 2016 and is expected to be completed by December 31, 2016. The Company’s previously-authorized share repurchase program expired on December 31, 2015.

Liquidity and Capital Resources

The table below presents selected liquidity and capital measures as of:

($ in millions)
December 31, 2015
 
December 31, 2014
Cash and cash equivalents
$
274.6

 
$
255.3

Working capital
$
359.4

 
$
406.6

Total debt
$
298.2

 
$
335.5

Total equity
$
1,023.9

 
$
956.9

Net debt-to-total invested capital
2.3
%
 
7.7
%

Cash and cash equivalents include all instruments that have maturities of ninety days or less when purchased. Working capital is defined as current assets less current liabilities. Net debt is defined as total debt less cash and cash equivalents, and total invested capital is defined as the sum of net debt and total equity. Net debt and total invested capital are non-U.S. GAAP financial measures that should not be used as a substitute for the comparable U.S. GAAP financial measures. The non-U.S. GAAP financial measures are incorporated into our discussion and analysis as management believes that this information provides users a valuable insight into our overall performance and financial position. Working capital, total debt, and net debt-to-total invested capital amounts and percentages reflect our adoption of the guidance issued by the FASB in 2015 regarding the classification of debt issuance costs.

Cash and cash equivalents – Our cash and cash equivalents balance at December 31, 2015 consisted of cash held in depository accounts with banks around the world and cash invested in high-quality, short-term investments. The cash and cash equivalents balance at December 31, 2015 included $141.2 million of cash held by subsidiaries within the U.S., and $133.4 million of cash held by subsidiaries outside of the U.S. Deferred income taxes have not been provided for any funds held by the subsidiaries outside of the U.S., as such earnings are intended to be reinvested indefinitely outside of the U.S.

Working capital - Working capital at December 31, 2015 decreased by $47.2 million, or 11.6%, as compared to December 31, 2014, including a decrease of $22.7 million due to foreign currency translation. Excluding the impact of currency exchange rates, cash and cash equivalents, accounts receivable and inventories increased by $41.4 million, $14.1 million and $11.4 million, respectively, and total current liabilities increased by $86.4 million. Accounts receivable and inventory turnover measurements remained consistent between December 31, 2014 and December 31, 2015. The increase in current liabilities was primarily due to the reclassification of our Series B Notes from long-term debt to current liabilities between those period ends and an increase in accounts payable, partially offset by the maturity of our Series B floating rate notes on July 28, 2015.

Debt and credit facilities - The $37.3 million decrease in total debt at December 31, 2015, as compared to December 31, 2014, resulted from net repayments of $27.4 million and foreign currency rate fluctuations of $10.1 million, partially offset by a reduction of $0.2 million in unamortized debt issuance costs.


35



On October 15, 2015, we entered into the New Credit Agreement that replaced our prior $300.0 million revolving credit facility, which was scheduled to expire in April 2017. The New Credit Agreement, which expires in October 2020, contains a $300.0 million credit facility, which may be increased from time to time by up to $100.0 million in the aggregate, subject to the satisfaction of certain conditions and upon approval by the banks. Up to $30.0 million of the credit facility is available for swing-line loans and up to $30.0 million is available for the issuance of standby letters of credit. Borrowings under the New Credit Agreement bear interest at either the base rate or at the applicable London Interbank Offered Rate ("LIBOR") rate, plus a tiered margin based on the ratio of our total debt to modified earnings before interest, taxes, depreciation and amortization ("EBITDA"), ranging from 0 to 75 basis points for base rate loans and 100 to 175 basis points for LIBOR rate loans. At December 31, 2015, we had $27.1 million in outstanding borrowings under the New Credit Agreement, of which $4.2 million was denominated in Yen and $22.9 million was denominated in Euro. The total amount outstanding at December 31, 2015 was classified as long-term. These borrowings, together with outstanding letters of credit of $3.0 million, resulted in a borrowing capacity available under the New Credit Agreement of $269.9 million at December 31, 2015. We do not expect any significant limitations on our ability to access this source of funds.

Pursuant to the financial covenants in our debt agreements, we are required to maintain established interest coverage ratios and to not exceed established leverage ratios. In addition, the agreements contain other customary covenants, none of which we consider restrictive to our operations. At December 31, 2015, we were in compliance with all of our debt covenants, and we expect to continue to be in compliance with the terms of these agreements throughout 2016.

We believe that cash on hand and cash generated from operations, together with availability under our multi-currency revolving credit facility, will be adequate to address our foreseeable liquidity needs based on our current expectations of our business operations, capital expenditures and scheduled payments of debt obligations.

Commitments and Contractual Obligations

The following table summarizes our contractual obligations and commitments at December 31, 2015. These obligations are not expected to have a material impact on liquidity.
 
 
Payments Due By Period
($ in millions)
Total
Less than 1 year
1 - 3 years
3 - 5 years
More than 5 years
Purchase obligations (1)
$
10.7

$
10.4

$
0.3

$

$

Long-term debt
299.2

69.3

34.8

27.1

168.0

Interest on long-term debt and interest rate swaps (2)
67.6

9.4

15.8

13.8

28.6

Operating lease obligations
58.2

9.6

13.1

7.6

27.9

Other long-term liabilities (3)
16.4

0.4

2.0

3.6

10.4

Total contractual obligations(4)
$
452.1

$
99.1

$
66.0

$
52.1

$
234.9


(1)
Our business creates a need to enter into various commitments with suppliers. In accordance with U.S. GAAP, these purchase obligations are not reflected in the accompanying consolidated balance sheets. These purchase commitments do not exceed our projected requirements and are in the normal course of business.

(2)
For fixed-rate long-term debt, interest was based on principal amounts and fixed coupon rates at year end. Future interest payments on variable-rate debt were calculated using principal amounts and the applicable ending interest rate at year end. Interest on fixed-rate derivative instruments was based on notional amounts and fixed interest rates contractually obligated at year end.

(3)
Represents acquisition-related contingencies. In connection with certain business acquisitions, we agreed to make payments to the sellers when and if certain operating milestones are achieved, such as sales and operating income targets.


36



(4)
This table does not include obligations pertaining to pension and postretirement benefits because the actual amount and timing of future contributions may vary significantly depending upon plan asset performance, benefit payments, and other factors. Contributions to our plans are expected to be $7.2 million in 2016. See Note 13, Benefit Plans, for estimated benefit payments over the next ten years.

Reserves for uncertain tax positions - The table above does not include $5.9 million of total gross unrecognized tax benefits as of December 31, 2015. Due to the high degree of uncertainty regarding the timing of potential cash flows, we cannot reasonably estimate the settlement periods for amounts which may be paid.

Letters of credit - We have letters of credit totaling $3.0 million supporting the reimbursement of workers' compensation and other claims paid on our behalf by insurance carriers. Our accrual for insurance obligations was $8.2 million at December 31, 2015, of which $4.1 million is in excess of our deductible and, therefore, is reimbursable by the insurance company.

OFF-BALANCE SHEET ARRANGEMENTS

At December 31, 2015, we had no off-balance sheet financing arrangements other than operating leases, unconditional purchase obligations incurred in the ordinary course of business, and outstanding letters of credit related to various insurance programs.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

Management's discussion and analysis addresses consolidated financial statements that are prepared in accordance with U.S. GAAP. The application of these principles requires management to make estimates and assumptions, some of which are subjective and complex, that affect the amounts reported in the consolidated financial statements. We believe the following accounting policies and estimates are critical to understanding and evaluating our results of operations and financial position:

Revenue Recognition: Revenue is recognized when persuasive evidence of a sales arrangement exists, title and risk of loss have transferred, the selling price is fixed or determinable, and collectability is reasonably assured. Generally, sales are recognized upon shipment or upon delivery to our customers' site, based upon shipping terms or legal requirements. Some customers receive pricing rebates upon attaining established sales volumes. We record rebate costs when sales occur based on our assessment of the likelihood that the required volumes will be attained. We also maintain an allowance for product returns, as we believe that we are able to reasonably estimate the amount of returns based on our substantial historical experience.

Impairment of Long-Lived Assets: Long-lived assets, including property, plant and equipment, are tested for impairment whenever circumstances indicate that the carrying value of these assets may not be recoverable. An asset is considered impaired if the carrying value of the asset exceeds the sum of the future expected undiscounted cash flows to be derived from the asset. Once an asset is considered impaired, an impairment loss is recorded within other (income) expense for the difference between the asset's carrying value and its fair value. For assets held and used in the business, management determines fair value using estimated future cash flows to be derived from the asset, discounted to a net present value using an appropriate discount rate. For assets held for sale or for investment purposes, management determines fair value by estimating the proceeds to be received upon sale of the asset, less disposition costs.

Impairment of Goodwill and Other Intangible Assets: Goodwill and indefinite-lived intangible assets are tested for impairment at least annually, following the completion of our annual budget and long-range planning process, or whenever circumstances indicate that the carrying value of these assets may not be recoverable. Goodwill is tested for impairment at the reporting unit level, which is the same as, or one level below, our operating segments. Recent accounting guidance allows entities to first assess qualitative factors, including macroeconomic conditions, industry and market considerations, cost factors, and overall financial performance, to determine whether it is necessary to perform the first step of the two-step quantitative goodwill impairment test. We considered this guidance when performing our annual impairment testing, but elected to continue utilizing the two-step quantitative impairment

37



test. The first step in the two-step test is to compare the fair value of each reporting unit to its carrying amount, including goodwill. If the carrying amount exceeds fair value, the second step must be performed. The second step requires the comparison of the carrying amount of the goodwill to its implied fair value, which is calculated as if the reporting unit had just been acquired as of the testing date. Any excess of the carrying amount of goodwill over the implied fair value would represent an impairment loss. Considerable management judgment is necessary to estimate fair value. Amounts and assumptions used in our goodwill impairment test, such as future sales, future cash flows and long-term growth rates, are consistent with internal projections and operating plans. Amounts and assumptions used in our goodwill impairment test are also largely dependent on the continued sale of drug products delivered by injection and the packaging of drug products, as well as our timeliness and success in new-product innovation or the development and commercialization of proprietary multi-component systems. Changes in the estimate of fair value, including the estimate of future cash flows, could have a material impact on our future results of operations and financial position. No impairment in the carrying value of our reporting units was evident as a result of our annual review of goodwill. With the exception of our Delivery Systems' Americas and Delivery Systems' Europe reporting units, each of which had a fair value in excess of its carrying value of approximately 20% and each of which is largely dependent on the continued and anticipated demand for certain of its contract manufacturing and proprietary products, each of our reporting units whose assets included goodwill had a fair value in excess of its respective carrying value of at least 150%. At December 31, 2015, the goodwill associated with the Delivery Systems' Americas and Europe reporting units equaled $39.7 million, or 38.0% of our total goodwill.

Certain trademarks have been determined to have indefinite lives and, therefore, are not subject to amortization. Similar to the impairment testing for goodwill, there is an option to first assess qualitative factors as a basis for determining whether it is necessary to perform a quantitative impairment test. We considered this option when performing our impairment testing, but elected to continue utilizing a quantitative test, comparing the fair value and carrying value of the asset. Any excess carrying value would represent an impairment loss. Fair values are determined using discounted cash flow analyses.

Intangible assets with finite lives are amortized using the straight-line method over their estimated useful lives, and reviewed for impairment whenever circumstances indicate that the carrying value of these assets may not be recoverable.

Employee Benefits: We maintain funded and unfunded defined benefit pension plans in the U.S. and a number of other countries that cover employees who meet eligibility requirements. In addition, we sponsor postretirement benefit plans which provide healthcare benefits for eligible employees who retire or become disabled. The measurement of annual cost and obligations under these defined benefit postretirement plans is subject to a number of assumptions, which are specific for each of our U.S. and foreign plans. The assumptions, which are reviewed at least annually, are relevant to both the plan assets (where applicable) and the obligation for benefits that will ultimately be provided to our employees. Two of the most critical assumptions in determining pension and retiree medical plan expense are the discount rate and expected long-term rate of return on plan assets. Other assumptions reflect demographic factors such as retirement age, rates of compensation increases, mortality and turnover and are evaluated periodically and updated to reflect our actual experience. For our funded plans, we consider the current and expected asset allocations of our plan assets, as well as historical and expected rates of return in estimating the long-term rate of return on plan assets. Under U.S. GAAP, differences between actual and expected results are generally accumulated in other comprehensive income (loss) as actuarial gains or losses and subsequently amortized into earnings over future periods.

Changes in key assumptions could have a material impact on our future results of operations and financial position. We estimate that every 25 basis point reduction in our long-term rate of return assumption would increase pension expense by $0.6 million, and every 25 basis point reduction in our discount rate would increase pension expense by $0.6 million. A decrease in the discount rate increases the present value of benefit obligations. Our net pension underfunded balance at December 31, 2015 was $57.4 million, compared to $76.2 million at December 31, 2014. Our underfunded balance for other postretirement benefits was $10.2 million at December 31, 2015, compared to $10.1 million at December 31, 2014.


38



Income Taxes: We estimate income taxes payable based upon current domestic and international tax legislation. In addition, deferred income tax assets and liabilities are established to recognize differences between the tax basis and financial statement carrying values of assets and liabilities. We maintain valuation allowances where it is more likely than not that all or a portion of a deferred tax asset will not be realized. The recoverability of tax assets is subject to our estimates of future profitability, generally at the respective subsidiary company and country level. Changes in tax legislation, business plans and other factors may affect the ultimate recoverability of tax assets or final tax payments, which could result in adjustments to tax expense in the period such change is determined.
 
When accounting for uncertainty in income taxes recognized in our financial statements, we apply a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.

Contingent Consideration

The fair value of the contingent consideration liability related to SmartDose ("SmartDose contingent consideration") was initially determined using a probability-weighted income approach, and is revalued at each reporting date or more frequently if circumstances dictate. Changes in the fair value of this obligation are recorded as income or expense within other expense (income) in our consolidated statements of income. The significant unobservable inputs used in the fair value measurement of the contingent consideration are the sales projections, the probability of success factors, and the discount rate. Significant increases or decreases in any of those inputs in isolation would result in a significantly lower or higher fair value measurement. As development and commercialization of SmartDose progresses, we may need to update the sales projections, the probability of success factors, and the discount rate used. This could result in a material increase or decrease to the contingent consideration liability.

See Note 1, Summary of Significant Accounting Policies and Note 2, New Accounting Standards, to our consolidated financial statements for additional information on accounting and reporting standards considered in the preparation and presentation of our financial statements.

ITEM 7A.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are exposed to various market risk factors such as fluctuating interest rates, foreign currency exchange rates and increasing commodity prices. These risk factors can impact our results of operations, cash flows and financial position. To manage these risks, we periodically enter into derivative financial instruments such as interest rate swaps, call options and forward exchange contracts for periods consistent with and for notional amounts equal to or less than the underlying exposures. In accordance with Company policy, derivative financial instruments are not used for speculation or trading purposes.

Foreign Currency Exchange Risk

Sales outside of the U.S. accounted for 52.0% of consolidated net sales in 2015. Virtually all of these sales and related operating costs are denominated in the currency of the local country and translated into USD for consolidated reporting purposes. Although the majority of the assets and liabilities of these subsidiaries are denominated in the functional currency of the subsidiary, they may also hold assets or liabilities denominated in other currencies. These items may give rise to foreign currency transaction gains and losses. As a result, our results of operations and financial position are exposed to changing currency exchange rates. We periodically use forward contracts to hedge certain transactions or to neutralize month-end balance sheet exposures on cross-currency intercompany loans.

We have designated our €61.1 million Euro note B and our €21.0 million Euro-denominated borrowings under our revolving credit facility as a hedge of our net investment in certain European subsidiaries. We also have ¥500.0 million in Yen-denominated borrowings under our revolving credit facility which has been designated as a hedge of our net investment in Daikyo. At December 31, 2015, a net cumulative foreign currency translation gain on these hedges of $5.8 million (net of tax of $3.4 million) was recorded within accumulated other comprehensive loss.


39



Interest Rate Risk

As a result of our normal borrowing activities, we have long-term debt with both fixed and variable interest rates. Long-term debt consists of senior notes, revolving credit facilities and capital lease obligations. Our exposures to fluctuations in interest rates are managed to the extent considered necessary by entering into interest rate swap agreements.

The following table summarizes our interest rate risk-sensitive instruments:

($ in millions)
2016
2017
2018
2019
2020
Thereafter
Carrying Value
Fair Value
Current Debt and Capital Leases:
 
 
 
 
 
 
 
 
U.S. dollar denominated (1)
$
2.5

 
 
 
 
 
$
2.5

$
2.5

Average interest rate - variable
1.7
%
 
 
 
 
 
 
 
U.S. dollar denominated
66.8

 
 
 
 
 
66.8

66.8

Average interest rate - variable
4.4
%
 
 
 
 
 
 
 
Long-Term Debt:
 
 
 
 
 
 
 
 
U.S. dollar denominated (1)
 
2.2

32.6


 
 
34.8

34.8

Average interest rate - variable
 
1.7
%
1.7
%

 
 
 
 
U.S. dollar denominated
 
 
 
 
 
168.0

168.0

163.1

Average interest rate - fixed
 
 
 
 
 
3.9
%
 
 
Euro denominated
 
 
 
 
22.9

 
22.9

22.9

Average interest rate - variable
 
 
 
 
1.7
%
 
 
 
Yen denominated
 
 
 
 
4.2

 
4.2

4.2

Average interest rate - variable
 
 
 
 
1.6
%
 
 
 

(1) As of December 31, 2015, we have a forward-start interest rate swap outstanding designed to hedge the variability in cash flows due to changes in the applicable interest rate of our $37.1 million five-year term loan. At December 31, 2015, this agreement had a fair value of $2.0 million, unfavorable to the Company, which was recorded as a noncurrent liability. Refer to Note 9, Derivative Financial Instruments, for additional information on this interest rate hedge.

Commodity Price Risk

Many of our Packaging Systems products are made from synthetic elastomers, which are derived from the petroleum refining process. We purchase the majority of our elastomers via long-term supply contracts, some of which contain clauses that provide for surcharges related to fluctuations in crude oil prices. In recent years, increases in raw material costs have had an adverse impact on us. We expect the volatility in raw material prices to continue. We will continue to pursue pricing and hedging strategies, and ongoing cost control initiatives to offset the effects on gross profit.

In November 2014, we purchased a series of call options for a total of 134,700 barrels of crude oil to mitigate our exposure to such oil-based surcharges and protect operating cash flows with regard to a portion of our forecasted elastomer purchases through December 2015. As of December 31, 2015, there were no options outstanding.

40



ITEM 8.  FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

CONSOLIDATED STATEMENTS OF INCOME
West Pharmaceutical Services, Inc. and Subsidiaries for the years ended December 31, 2015, 2014 and 2013
(In millions, except per share data)


 
 
2015
 
2014
 
2013
Net sales
 
$
1,399.8

 
$
1,421.4

 
$
1,368.4

Cost of goods and services sold
 
944.0

 
973.6

 
933.7

Gross profit
 
455.8

 
447.8

 
434.7

Research and development
 
34.1

 
37.3

 
37.9

Selling, general and administrative expenses
 
233.0

 
228.7

 
234.9

Other expense (income) (Note 14)
 
60.1

 
(0.2
)
 
(0.5
)
Operating profit
 
128.6

 
182.0

 
162.4

Loss on debt extinguishment
 

 

 
0.2

Interest expense
 
14.1

 
16.5

 
17.0

Interest income
 
1.6

 
3.5

 
1.9

Income before income taxes
 
116.1

 
169.0

 
147.1

Income tax expense
 
26.3

 
47.2

 
40.2

Equity in net income of affiliated companies
 
5.8

 
5.3

 
5.4

Net income
 
$
95.6

 
$
127.1

 
$
112.3

 
 
 
 
 
 
 
Net income per share:
 
 

 
 

 
 
Basic
 
$
1.33

 
$
1.79

 
$
1.61

Diluted
 
$
1.30

 
$
1.75

 
$
1.57

 
 
 
 
 
 
 
Weighted average shares outstanding:
 
 

 
 

 
 
Basic
 
72.0

 
70.9

 
69.6

Diluted
 
73.8

 
72.8

 
71.4

 
 
 
 
 
 
 
Dividends declared per share
 
$
0.46

 
$
0.41

 
$
0.39


The accompanying notes are an integral part of the consolidated financial statements.

41



CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
West Pharmaceutical Services, Inc. and Subsidiaries for the years ended December 31, 2015, 2014 and 2013
(In millions)

 
2015
 
2014
 
2013
Net income
$
95.6

 
$
127.1

 
$
112.3

Other comprehensive (loss) income, net of tax:
 

 
 

 
 
Foreign currency translation adjustments
(70.3
)
 
(71.3
)
 
(0.9
)
Defined benefit pension and other postretirement plans:
 
 
 
 
 
Prior service credit arising during period, net of tax of $0.3
0.4

 

 

Net actuarial (loss) gain arising during period, net of tax of $(6.0), $(10.6) and $20.3
(9.3
)
 
(18.9
)
 
33.7

Settlement effects arising during the period, net of tax of $18.7
31.7

 

 

Less: amortization of actuarial loss, net of tax of $1.6, $1.1 and $3.6
2.9

 
2.0

 
4.9

Less: amortization of prior service credit, net of tax of $(0.5), $(0.5) and $(0.5)
(0.8
)
 
(0.8
)
 
(0.8
)
Less: amortization of transition obligation
0.1

 
0.1

 
0.1

Net gains on investment securities, net of tax of $0.4, $0.2 and $2.1
0.7

 
0.4

 
3.5

Net gains on derivatives, net of tax of $0.8, 0.9 and $1.8
1.2

 
1.7

 
3.0

Other comprehensive (loss) income, net of tax
(43.4
)
 
(86.8
)
 
43.5

Comprehensive income
$
52.2

 
$
40.3

 
$
155.8


The accompanying notes are an integral part of the consolidated financial statements.

42



CONSOLIDATED BALANCE SHEETS
West Pharmaceutical Services, Inc. and Subsidiaries at December 31, 2015 and 2014
(In millions, except per share data)
 
2015
 
2014
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
274.6

 
$
255.3

Accounts receivable, net
181.4

 
179.0

Inventories
181.1

 
181.5

Deferred income taxes

 
7.8

Other current assets
36.6

 
35.5

Total current assets
673.7

 
659.1

Property, plant and equipment
1,440.3

 
1,390.8

Less accumulated depreciation
719.3

 
685.0

Property, plant and equipment, net
721.0

 
705.8

Investments in affiliated companies
61.3

 
60.6

Goodwill
104.6

 
108.6

Deferred income taxes
70.5

 
66.1

Intangible assets, net
37.6

 
42.0

Other noncurrent assets
26.4

 
27.5

Total Assets
$
1,695.1

 
$
1,669.7

 
 
 
 
LIABILITIES AND EQUITY
 

 
 

Current liabilities:
 

 
 

Notes payable and other current debt
$
69.3

 
$
27.2

Accounts payable
119.8

 
103.1

Pension and other postretirement benefits
5.6

 
2.6

Accrued salaries, wages and benefits
53.0

 
52.9

Income taxes payable
12.8

 
14.9

Other current liabilities
53.8

 
51.8

Total current liabilities
314.3

 
252.5

Long-term debt
228.9

 
308.3

Deferred income taxes
12.4

 
15.7

Pension and other postretirement benefits
62.0

 
83.7

Other long-term liabilities
53.6

 
52.6

Total Liabilities
671.2

 
712.8

 
 
 
 
Commitments and contingencies (Note 16)


 


 
 
 
 
Equity:
 
 
 
Preferred stock, 3.0 million shares authorized; 0 shares issued and 0 shares outstanding in 2015 and 2014

 

Common stock, par value $.25 per share; 100.0 million shares authorized; shares issued: 72.4 million and 71.4 million; shares outstanding: 72.3 million and 71.3 million
18.1

 
17.8

Capital in excess of par value
207.8

 
160.2

Retained earnings
964.6

 
902.2

Accumulated other comprehensive loss
(162.6
)
 
(119.2
)
Treasury stock, at cost (0.1 million shares in 2015 and 2014)
(4.0
)
 
(4.1
)
Total Equity
1,023.9

 
956.9

Total Liabilities and Equity
$
1,695.1

 
$
1,669.7


The accompanying notes are an integral part of the consolidated financial statements.

43



CONSOLIDATED STATEMENT OF EQUITY
West Pharmaceutical Services, Inc. and Subsidiaries for the years ended December 31, 2015, 2014 and 2013
(In millions)
 
Common Shares Issued
 
Common Stock
 
Capital in Excess of Par Value
 
Number of Treasury Shares
 
Treasury Stock
 
Retained earnings
 
Accumulated other comprehensive loss
 
Total
Balance, December 31, 2012
68.8

 
$
17.2

 
$
70.7

 
0.2

 
$
(3.0
)
 
$
719.9

 
$
(75.9
)
 
$
728.9

Net income

 

 

 

 

 
112.3

 

 
112.3

Stock-based compensation

 

 
15.3

 

 

 

 

 
15.3

Shares issued under stock plans
1.8

 
0.4

 
30.9

 

 
(0.8
)
 

 

 
30.5

Shares repurchased for employee tax withholdings
(0.2
)
 

 
(5.2
)
 

 

 

 

 
(5.2
)
Excess tax benefit from employee stock plans

 

 
8.3

 

 

 

 

 
8.3

Dividends declared

 

 

 

 

 
(27.2
)
 

 
(27.2
)
Other comprehensive income, net of tax

 

 

 

 

 

 
43.5

 
43.5

Balance, December 31, 2013
70.4

 
17.6

 
120.0

 
0.2

 
(3.8
)
 
805.0

 
(32.4
)

906.4

Net income

 

 

 

 

 
127.1

 

 
127.1

Stock-based compensation

 

 
15.5

 

 
(0.3
)
 

 

 
15.2

Shares issued under stock plans
1.1

 
0.2

 
20.9

 
(0.1
)
 

 

 

 
21.1

Shares repurchased for employee tax withholdings
(0.1
)
 

 
(4.1
)
 

 

 

 

 
(4.1
)
Excess tax benefit from employee stock plans

 

 
7.9

 

 

 

 

 
7.9

Dividends declared

 

 

 

 

 
(29.9
)
 

 
(29.9
)
Other comprehensive loss, net of tax

 

 

 

 

 

 
(86.8
)
 
(86.8
)
Balance, December 31, 2014
71.4

 
17.8

 
160.2

 
0.1

 
(4.1
)
 
902.2

 
(119.2
)
 
956.9

Net income


 

 

 

 

 
95.6

 

 
95.6

Stock-based compensation

 
0.1

 
26.4

 

 
0.2

 

 

 
26.7

Shares issued under stock plans
1.1

 
0.2

 
17.6

 

 

 

 

 
17.8

Shares repurchased for employee tax withholdings
(0.1
)
 

 
(5.5
)
 

 
(0.1
)
 

 

 
(5.6
)
Excess tax benefit from employee stock plans

 

 
9.1

 

 

 

 

 
9.1

Dividends declared

 

 

 

 

 
(33.2
)
 

 
(33.2
)
Other comprehensive loss, net of tax

 

 

 

 

 

 
(43.4
)
 
(43.4
)
Balance, December 31, 2015
72.4

 
$
18.1

 
$
207.8

 
0.1

 
$
(4.0
)
 
$
964.6

 
$
(162.6
)
 
$
1,023.9


The accompanying notes are an integral part of the consolidated financial statements.

44



CONSOLIDATED STATEMENTS OF CASH FLOWS
West Pharmaceutical Services, Inc. and Subsidiaries for the years ended December 31, 2015, 2014 and 2013
(In millions)
 
2015
 
2014
 
2013
Cash flows from operating activities:
 
 
 
 
 
Net income
$
95.6

 
$
127.1

 
$
112.3

Adjustments to reconcile net income to net cash provided by operating activities:
 
 
 
 
 
Depreciation
86.1

 
84.8

 
81.0

Amortization
3.8

 
5.2

 
4.2

Loss on debt extinguishment

 

 
0.2

Stock-based compensation
29.6

 
18.6

 
21.2

Pension settlement charge
50.4

 

 

Loss on sales of equipment
0.4

 
0.3

 
0.4

Deferred income taxes
(8.9
)
 
7.0

 
1.7

Pension and other retirement plans, net
(28.8
)
 
(25.0
)
 
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