West Pharmaceutical Services, Inc. (WST)

Washington, D. C. Securities and Exchange CommissionC. 20549 FORM 10-K (Mark One)
Annual Report submitted under Section 13 or 15 (d)
Pursuant to section 1934th or section 15th, the Securities Trading Act or transition report for the fiscal year ended December 31, 2015 (d)
Securities Exchange Act No. 1934th on transition period from Document No. 1 to Document No. 1
8036 Western Medicine Service Co. , Ltd. (
The exact name of the registrant specified in the articles of association)
Pennsylvania 23-1210010 (
State or other jurisdiction registered or organized)(I. R. S.
Employer identification number)530 Herman O.
West Avenue, Exton, PA 19341-0645 (
Main executive office address)(Zip Code)
The telephone number of the registrant, including the area code: 610-594-
2900 securities registered under article 12 (b)
Title of the act: each class name of each exchange registered with common stock, with a par value of $.
25 shares of New York Stock Exchange securities registered under article 12 (g)
Key points of the bill: no one indicates by check mark whether the registrant is a well or not
Well-known experienced issuers as defined in Rule 405 of the Securities Act.
Yes, no o indicate by check mark whether the registrant does not need to submit a report under Section 13 or section 15 (d)of the Act.
Yes o no check mark indicates whether the registrant (1)
All reports requested by Article 13 or 15 have been submitted (d)
Securities Trading Act of 1934 within the first 12 months (
Or a short period of time required for the registrant to submit such reports), and (2)
This filing requirement has been bound for the last 90 days.
Yes, no o indicates by check mark whether the registrant has submitted and posted electronically on its company website (if any ), each interactive data file submitted and published as required by S-regulation 405th
12 months before T (
Or in such a short time that the registrant is required to submit and publish these documents).
If the default declarant is disclosed under section S-405 of the regulations, no o indicates by check mark
To the knowledge of the registrant, K is not included in the final proxy or information statement referenced in Part 3 of this Form 10 and will not be included in it
K or any amendments to this form 10K.
O indicate by check mark whether the registrant is a large accelerated filer, non-accelerated filer
A smaller reporting company.
See the definition of \"large accelerated file manager\", \"accelerated file manager\" and \"small Reporting Company\" in rule 12b
2 of the Trading Act.
Large acceleration filer non-acceleration filer
Accelerate filer o (
Do not check if there are smaller reporting companies)
The smaller reporting company o indicates whether the registrant is a shell company through a check mark (
Defined in Rule 12b-
2 parts of the transaction law).
Yes o no total market value of non-voting shares
As of June 30, 2015, the registrant\'s affiliates reported a closing price of approximately $4,181,975,535 based on the New York Stock Exchange.
As of January 31, 2016, 72,333,516 ordinary shares of the registrant had been issued.
The documents incorporated in the reference document section include the agency statement for the annual meeting of shareholders to be held on May 3, 2016 Part III Catalogue Part I, page 1, Item 1.
Business project 1A.
Risk factors for project 1B.
Unresolved staff review Item 2.
Property item 3.
The fourth legal action.
Mine safety disclosure executive officer of Part II Project 5 of the company.
Market for registrant common stock, related shareholder matters and issuer to purchase equity securities
Selected Financial Data Items 7.
Management\'s Discussion and Analysis of the financial status and results of the operating project 7A.
Quantitative and Qualitative Disclosure on market risk item 8.
Financial statements and supplementary materials item 9.
Changes in accounting and financial disclosure project 9A and differences with accountants.
Control and procedures for Item 9B.
The tenth item of the third part.
Project 11 of directors, executive officers and corporate governance.
Item 12 of administrative compensation.
Security title matters of certain beneficial owners and management and related shareholders 13.
Director independence item 14: certain relationships and related party transactions.
Part IV main accounting expenses and services for item 15.
Attachment Index 2 part 1 item 1.
Western medicine Service Co. , Ltd. (
Company, US or ours ).
It is a manufacturer that produces components and systems for injection drug packaging and delivery, as well as components in the pharmaceutical, healthcare and consumer goods industries.
Our products include plugs and seals for vials, components and systems for pre-filled syringes, components for venous and blood collection systems, safety and management systems, advanced injection systems and contract design and manufacturing
Our customers include the world\'s leading manufacturers of medicines, biological products, medical devices and consumer goods.
The company was established in July 27, 1923 under the federal law of Pennsylvania.
All trademarks and registered trademarks used in this report are the property of Western medicine services
Directly or indirectly through its subsidiaries unless otherwise stated.
Crystal Sky top Big Beijing:®(“CZ ® ”)
It is a registered trademark of Dajing Seiko Co. , Ltd. (\"Daikyo\").
In this report, the reference to \"notes\" refers to notes to consolidated financial statements contained in Item 8 of Part II of this year\'s report, Form 10-K (\"Form 10-K\")
Unless otherwise stated.
We maintain a website on www. westpharma. com . Our Form 10-
Quarterly Report on table 10
Q: Current Report of Form 8
K and amendments to reports submitted or provided under section 13 (a)or 15(d)
According to the requirements of investors, the securities trading Law of 1934 is available on our website
SEC submission title after we file or provide the material electronically to the United States, as long as it is reasonably practicableS.
Securities and Exchange Commission (“SEC”).
These documents can also be made available to the public via the Internet on the SEC\'s website www. sec. gov .
You can also read and copy any documents we submit on the 100 th floor of the SEC public expansion roomStreet, N. E. Washington, D. C. C. 20549.
Please in 1-800-SEC-
0330 further information on public information rooms.
The entire Form 10-
K, by reference to certain parts of the other documents submitted to SEC and certain information in the proxy statement of our 2016 annual shareholders meeting (
\"2016 statement of Proxy \")
This will be submitted to the SEC within 120 days of the end of our fiscal 2015.
Our 2016 proxy statement will be published on our website on or around March 31, 2016, titled investor-
Annual Report & Agency
Information on our corporate governance, including our principles of corporate governance and business code of conduct, as well as information on our directors, board committees, board articles of association, instructions on how to contact the board can be found on our website under Investors --
Corporate governance title.
We intend to make any necessary disclosure regarding any amendments or exemptions to the code of conduct for Business granted to any of our directors or executive officers under the heading of the code of conduct on our website.
Information about the dividend reinvestment plan for Western medicine services is also available to investors on our website-
Title of transfer agent/dividend reinvestment.
We will provide any of the above information to our Western medicine service company secretary free of charge upon written request, 530 Herman O.
West Avenue, Exton, PA 19341.
Of the 3 business units of 2015, our business consists of two reporting departments, the pharmaceutical packaging system department (
Packaging System]
Pharmaceutical Distribution System sector (
\"Delivery System \").
Starting in 2016, we are changing our organizational and reporting structure for the next phase of growth and development, which will lead to changes in proprietary products and contracts
Manufacturing products that can be reported.
The proprietary product Reporting Section combines the existing packaging system section with the proprietary product section of the existing delivery system section, which will develop business, operations and innovation strategies in our global network, special emphasis is placed on providing products to biological, generic and pharmaceutical customers. The Contract-
The manufacturing product report-able section, which will consist of the contract manufacturing section of the existing delivery system section, will become a focus on design, manufacturing, automated assembly of complex components for pharmaceutical and medical device customers.
Information and discussion contained in Table 10-
K reflects the structure as at December 31, 2015.
Packaging System part our packaging system part includes the main packaging parts and systems for injection drug delivery, includes plugs and pre-filled syringe parts for vials, caps and other components used in syringes, veins and blood collection systems.
Growth strategies for packaging systems include organic growth through market segmentation
Product innovation, strategic M & A and regional expansion.
We have production facilities in North and South America, Europe and Asia Pacific, with affiliates in Mexico and Japan.
See item 2 \"properties\" for additional information about our manufacturing and other websites \".
The packaging system consists of three operating parts
Americas, Europe and Asia Pacific
Summarized for reporting purposes.
The product of the packaging system usually consists of a variety of standards and elastic components provided by the customer
Specific Configurations and formulations can be used with advanced barrier films and coatings to improve their performance.
Silverrotek®The application of barrier film reduces the risk of loss of products due to pollution and protects the shelf life of packaged drugs.
We also apply the fluorine polymer laminate to the surface of the stopper and piston to improve the compatibility between the closure and the drug. B2-
The coating is a coating that is applied to the surface of the stopper and piston without the need for traditional silicone applications.
It can help manufacturers reduce product rejection due to non-trace silicon molecules
Drug compounds for coating packaging.
FluroTec and B2-
Paint technology is licensed from Beijing.
Also, our Westar®RS and Westar®After RU
The manufacturing process is documented and fully effective procedures have been developed for cleaning, silicone and sanitizing the plug and syringe components.
The Westar RS process is ready to introduce the components of the customer sterilizer, and the Westar RU process provides the sterilized components.
These processes improve the overall efficiency of injection drug production by outsourcing component processing, thereby eliminating other required steps in our customer\'s manufacturing process and helping to ensure compliance with the latest regulatory requirements for ingredient preparation.
We also provide peace and tranquility. ™Use the components checked by the automatic visual inspection system to ensure that the components (
Pistons and plugs)
Meet the enhanced quality specifications for visible and sub-visible particle pollution.
In 2015, we introduced the use of clean, high
High quality rubber formula, then wash, camera-
Checked and disinfected to help reduce the customer\'s manufacturing footprint, streamline the process, minimize the risk of component preparation, and eliminate biological loads.
We NovaPure®Components including serum and freeze-dried plugs and syringe Pistons combine quality according to design principles and are manufactured using advanced process technology.
These closures provide the highest level of quality for the market, helping to ensure the safety, effectiveness and purity of the injected drug. 4 Our tamper-evident Flip-
Closed®Seals are sold in a variety of sizes and colors to meet customer needs for product identification and differentiated.
Seals can be provided using proprietary printing for warning statements and embossed technologies that act as a deterrent against counterfeiting.
Seal our latest sterile medicine bottle, flip
Off Plus RU seal offers ready-made pharmaceutical manufacturers around the worldto-use, high-
High-quality seals, while minimizing biological load and particle levels, always achieve repeatable and safe integrity of drug containers.
As an auxiliary product for packaging system products, we provide contract analysis laboratory services for testing and evaluating major drugs
Packaging ingredients and their compatibility with pharmaceutical preparations contained.
West analytics services for customers
Gain an in-depth understanding and analysis of the interactions and compatibility of medicines with rubber, glass and plastic packaging components.
Our analytical laboratory also provides professional testing for a complete drug delivery system.
For information on net sales and assets of the packaging system, see Note 17 \"breakdown Information \".
Our delivery systems division includes security and management systems.
Component systems and various custom contracts for drug containment and management
Manufacturing solutions for healthcare and consumers
Product industry.
Delivery systems have expertise in product design and development, including
Design and construction of house mold, development and prototype tools, process design and validation and high
Fast automatic assembly.
In addition, the delivery system is responsible for the continuous development and commercialisation of our proprietary healthcare, administrative and advanced injection systems (including Dajing CZ) series®, SmartDose®And other systems.
Delivery systems have manufacturing operations in North America and Europe.
See item 2 \"properties\" for additional information about our manufacturing and other websites \".
The delivery system includes a variety of products and services as described below: the daikidcz 1 mL long insertion needle syringe system is the first polymer syringe system in the market without silicone oil lubrication, suitable for the barrel or piston containing the insert
Mold the needle to avoid the need for adhesive.
The luer lock version of the daikidcz syringe system was previously introduced, as well as several sizes of sterile vials.
Continue to roll out more sizes of vials.
CZ technology is licensed from grand Beijing.
The development of our SmartDose electronic wearable syringes continues to gain momentum in the market, and there are already many active development projects.
The system is designed for the control, subcutaneous delivery of high volume and high viscosity drugs using pre-filled Dajing CZ boxes.
The system is fully programmable with a single push
Button operation and safety hazard needle.
The mood to talk®Automatic-
Syringe and self-dose TM
The injection system enhances patient compliance and safety.
The needle remains automatically shielded at all times.
These systems eliminate the preparation steps, simplify the injection of drugs, and provide patients with sterile, single
Use a disposable system that can be easily used at home.
Our management system includes sterile equipment for drug preparation and management, including patented products such as mixitem®Transmission Device, Mix2Vial®Vial2Bag needle-free restructuring system®System and various vial adapters.
An example of the safety system we designed to prevent the needle stick is™And NovaGuard. ®SA of precharged syringes and NovaGuard®LP of Luer lock syringe.
We offer customer contracts.
Manufacturing and assembly solutions that use multiple technologies
Component forming, in-
Mold Labeling, ultrasonic welding and clean room molding and equipment components for manufacturing customers
Self-owned components and equipment for surgery, diagnosis, ophthalmology, other drug delivery systems and consumer goods.
For net sales and asset information for delivery systems, see Note 17, segment information.
We have important business outside the US (\"U. S. \")
It is managed through the same business unit as our USS.
Packaging System and delivery system.
Sales outside the United StatesS.
Accounted for 52.
0% of net sales in 2015.
For geographic breakdown of sales, see Note 17 \"Segment Information \".
Although the general business process is similar to the domestic business, the international business faces additional risks.
These risks include exchange rate fluctuations relative to the United States. S. Dollar (\"USD\")
Political and social issues in multiple tax jurisdictions, especially in South America and Israel, may undermine the stability of local markets and affect the demand for our products.
Please see further discussions on our international business, the risks associated with our international business and our minimizing these risks in Part I, Item 1A Risk Factors;
Part II, Item 7, Management\'s Discussion and Analysis of the financial position and operational results under the heading \"financial position, liquidity and capital resources;
Part II, Item 7A, quantitative and qualitative disclosure of market risks;
Note 1 translation of financial instruments and foreign currencies under the heading;
Note 9 on derivative financial instruments.
Raw materials we use three basic raw materials in product manufacturing: elastic materials, aluminum materials and plastic materials.
Elastic materials include natural and synthetic materials.
We can currently obtain sufficient supply of these raw materials through agreements with suppliers to meet our production needs.
We use supply.
Our business unit\'s supply chain management strategy includes sourcing from integrated suppliers that control their own supply sources.
Due to the regulatory control of our production process, as well as the cost and time involved by qualified suppliers, we rely on a single
Sourcing suppliers for many key raw materials.
We buy certain raw materials in the open market.
This strategy increases the risk that our supply chain may be interrupted when the supplier is producing problems.
Where possible, manage these risks by selecting suppliers with multiple manufacturing locations, strict quality control systems, remaining inventory levels, and other means of maintaining supply when production breaks
Intellectual property including patents, trade secrets and intellectual property
How, is important to our business.
We have perhaps intellectual property rights, including patents issued in the United States and patents being appliedS.
In other countries related to all aspects of our products.
Key values in particular-
The added and proprietary products and processes are licensed from the Flipkart.
Our intellectual property rights are useful in establishing our market share and business growth and are expected to continue to be of value in the future.
Although our packaging system business is not seasonal, sales and operating profits in the second half of the year are usually lower than in the first half, mainly due to factory shutdowns in our customers\' production plans and annual plans --
The final impact of the holiday on production.
Our delivery system business is not seasonal.
In order to meet the requirements of our customers, we need to carry a large inventory.
In addition, some of our supply agreements require us to purchase inventory in the form of bulk orders, which increases the level of inventory but reduces the risk of supply disruption.
Inventory levels are also affected by the above seasonal patterns.
For a more detailed discussion of working capital, see the discussion in Part II, Item VII, \"Management\'s Discussion and Analysis of Financial Position and operational results\" under the heading \"financial position\", liquidity and capital resources
Marketing our packaging system customers include most of the world\'s major branded pharmaceutical, generic and bio-pharmaceutical companies.
Packaging system components and other products are sold to major pharmaceutical, biotechnology and hospital supply/medical device companies that integrate them into their products for final salesuser.
Our delivery systems division sells to many of the world\'s largest pharmaceutical, bio-pharmaceutical and medical device companies, as well as big customers in the consumer and food industries --and-
Beverage industry.
Delivery system components are generally integrated into the production line of our customers for further processing or assembly.
Our products and services are mainly distributed through our own sales team and distribution network, and the use of contract sales agents and regional distributors is limited.
Our ten big customers account for 42.
In 2015, our combined net sales were 0%, but none of these customers accounted for more than 10% of the net sales alone.
For sales information by important product groups, see Note 17 \"breakdown Information \".
The order backlog includes a fixed order placed by the customer for manufacturing for a period of time based on their schedule or after customer confirmation.
We also have contractual arrangements with some of our clients.
The products covered by these contracts are only included in our backlog when an order is received.
The backlog of orders may be positively or negatively affected by several factors, including the customer ordering model and the necessary leads
Time to deliver customer orders.
The order backlog is one of many measures we use to understand future demand and should not be considered in isolation to anticipate future sales growth.
As of December 31, 2015 and 2014, the backlog of orders for the packaging system was $413.
$2 million and $339.
7 million respectively.
The increase in backlog mainly reflects changes in customer ordering patterns and expanding leads
Some higher Times
Value products are partially offset by adverse foreign currency effects.
In 2015, we have some customers placing orders in advance, some customers one year in advance, while others pay more attention to short-term orders. term stock-building.
It is expected that the entire order backlog for the packaging system in December 31, 2015 will be filled during 2016.
The manufacturing activities of most delivery systems are subject to the expected number of contracts for a period of one to three years and are regularly revised as required by the customer.
In our packaging system product line, we compete with several companies.
Because of the special nature of our pharmaceutical packaging components and our long term
Competition is mainly based on product design and performance, although the total cost becomes more and more important as pharmaceutical companies continue to actively control costs
Control programs in their operations.
As a global supplier capable of providing pre-packaging and delivery systems, we are different from our competitors
Sales of primary packaging support and engineering development, analytical services, 7 regulatory expertise and after-sales service
Sales technical support.
Customers also appreciate the global scope of Western manufacturing capabilities and our ability to produce many products in multiple locations.
Our delivery system business operates in a very competitive market for healthcare and consumer products.
Competition varies from smaller regional companies to large global imitators.
Given the huge cost pressures they face, many of our customers think
The coast that reduces costs.
By leveraging our global capabilities and adopting new technologies, such
Quick automatic assembly, insertmolding, multi-
Injection molding and expertise with multiple functions
Closed system.
There are few competitors supplying medical devices and medical device components.
We compete in this market based on the quality and reliability of engineering and project management, different contract manufacturing capabilities and knowledge and experience of complying with US regulationsS.
Food and Drug Administration (\"FDA\")requirements.
We also have specialized knowledge of containers and closed parts, which is indispensable for the development of delivery systems.
With our range of proprietary technologies, we compete with newly established companies in the field of drug delivery equipment, including suppliers of pre-filled syringes, automatic syringes
Syringes, safety needles and other proprietary systems.
We maintain our own research and development activities.
Develop scale production facilities and laboratories for new products and provide contract engineering design and development services to help customers develop new products.
Our quality control, regulatory and laboratory testing capabilities are used to ensure that primary and secondary pharmaceutical packaging components meet applicable manufacturing and regulatory standards.
The engineering department is responsible for the design and testing of products and tooling, and is responsible for the design and construction of processing equipment.
We continue to seek new and innovative opportunities to acquire, license, collaborate or develop products, services and technologies that serve the market for the containment and delivery of injecting drugs.
As we seek an innovative strategic platform in terms of pre-filled syringes, injection containers, advanced injection and safety management systems, R & D spending will continue to increase.
The commercial development of new products and services we use for medical and pharmaceutical applications usually takes several years.
New products we develop may need to be approved separately as medical devices, and, products intended for packaging and delivery of pharmaceutical products will be subject to customer acceptance of our products and regulatory approval of customer products after our development period. We spent $14.
It was $4 million in 2015.
In 2014, it was $3 million and $15.
1 million development of packaging systems in 2013.
R & D costs for delivery systems are $19. $21, 7 million.
Millions and $22.
8 million in 2015, 2014 and 2013 respectively.
Environmental regulations we are subject to various federal, state and local regulations that regulate the discharge of materials into the environment or other aspects related to environmental protection.
Our compliance with these laws and regulations has no significant impact on our financial position, operating results or cash flow.
In 2015, there was no material capital expenditure for environmental control facilities, and in 2016 there was no planned material expenditure for this purpose.
As of December 31, 2015, we have employed approximately 7,100 employees in our business units around the world. 8 ITEM 1A.
Risk factors the statements in this section describe the main risks of our business and should be considered carefully.
In addition, under the Private Securities Litigation Reform Act of 1995, these statements constitute our warning statements.
Our disclosure and analysis in form 10
K contains some forward
Forward-looking statements based on management\'s beliefs and assumptions, current expectations, estimates and forecasts.
We also provide
Other materials we issue to the public as well as statements in oral forwarding
Look at the report.
These statements give our current expectations or forecasts of future events.
They are not strictly related to history or reality.
Where possible, we try to determine where we are going.
Use words such as \"estimate\", \"expectation\", \"intention\", \"believe\", \"plan\", \"expectation\" and other words and terms with similar meanings to find statements.
In particular, these include future performance or results with future actions, business plans and prospects, new products, current or expected products, sales efforts, fees, interest rates, foreign countries
Exchange rate, economic impact, legal proceedings and other unexpected results and financial results.
Many of the factors that determine our future results are beyond our control or prediction.
The realization of future results is affected by known or unknown risks or uncertainties, so actual results may differ materially from past results, as well as those expressed or implied in any forward results
Statement.
You should keep this in mind when you consider moving forward
Look at the report.
We have no obligation to publicly update unless required by applicable securities law-
Reports can be viewed for new information, future events, or other reasons.
We also introduce you to our further disclosure of related topics in our Quarterly Report on Form 10 --
Q and Current Report on Table 8K to the SEC.
Unfavorable economic and market conditions may adversely affect our operating results.
Current uncertainties in the global economy, including the continuing impact of the recession or the slow growth of the US economyS.
Emerging markets in Europe and Asia and South America may have a negative impact on our operational results.
Examples of the impact of these ongoing global economic challenges include: the inability of our suppliers and our customers to enter the credit market at commercially reasonable rates;
Reduced sales due to reduced customer inventoryterm or long-
Difficult term or liquidity;
Due to the shortage of materials we buy from our suppliers, sales are reduced;
Reduce customer R & D efforts and expenses;
We are unable to hedge our currency and raw material risks adequately or at commercially reasonable prices;
Bankruptcy of supplier or customer;
Our supply or products are under inflationary pressure;
Due to an increase in taxes on the company\'s profits or revenues, the expenses increase.
Our operating results in one or more geographic regions may also be affected by uncertain or changing economic conditions in the region.
If the economy and market conditions of the United StatesS.
Further weakening in Europe or emerging markets, we may have a significant adverse impact on our business, financial position and operational results.
Our sales and profitability depend to a large extent on the sales of drugs delivered through injection and drug packaging.
If our customers use another delivery system for products developed in the future, our sales and profitability may be affected.
Our business largely depends on the ongoing sales and development of products delivered through injection.
Our sales and profitability may be affected if our customers fail to continue selling, developing and deploying injection products, or if we are unable to develop new products that help deliver drugs through alternative methods.
Changes in foreign exchange rates may have a significant adverse effect on our business and/or operational results.
Our business is affected by fluctuations in foreign exchange rates.
Sales outside the United StatesS.
Accounted for 52.
We combined 0% of net sales in 2015, and we expect sales in international operations to continue to account for a large part of our total future sales.
In addition, many of our manufacturing facilities and suppliers are located outside the United States. S.
In addition, we intend to continue to grow towards emerging markets and/or faster --
Growing markets outside the United StatesS. in the future.
In fact, all of our international sales, assets and associated operating costs and expenses are earned, valued or incurred in the currency of the local country, mainly in euros, Singapore dollars, and Danish crowns.
In addition, we touch the yen (\"Yen\")
As we have 25% ownership of Dajing and we buy finished products and other materials from Dajing.
We are also exposed to currencies in emerging market countries such as RMB, Indian rupee and various South American currencies, including Venezuela bolivar and Brazil real.
Our consolidated financial statements are in US dollars and, therefore, we must translate the reported value of our foreign assets, liabilities, income and expenditure into US dollars, this can lead to significant fluctuations in these assets, liabilities, income or expenses.
In recent years, the exchange rate between these foreign currencies and the US dollar has fluctuated greatly and may continue to fluctuate in the future.
An increase or decrease in dollar value compared to these foreign currencies may have a negative impact on the value of these items in our consolidated financial statements, which may have a significant adverse effect on our operational results
In addition to the translation risk, when we or one of our subsidiaries make a purchase or sale transaction in a currency other than that entity\'s local currency, we create a currency transaction risk.
To reduce our exposure to certain exchange rate fluctuations, we have entered and are expected to continue to move into hedging arrangements, including the use of financial derivatives.
We are not sure if we can hedge against these currency risks or if our hedging is valid. This may have a significant impact on our financial position and results of our operations.
If we can\'t provide comparative value advantage, we can\'t complete customer orders in time, we can\'t resist price pressure, then we have to reduce the price, which may reduce our profit margin.
We compete with several companies on the main product line.
Due to the special nature of these products, the competition is mainly based on product design and performance, although the total cost becomes more and more important as pharmaceutical companies continue to actively control costs
Control programs in their operations.
Competitors often compete on a price basis.
We distinguish ourselves from our competitors. service, value-
Added \"can provide pre-
Sales compatibility research and other services and complex after-sales service
Sales Technical support worldwide.
However, we are under constant pricing pressure from our customers and competitors.
If we can\'t resist or offset the impact of ongoing pricing pressure through our value --
Increase services, improve operational efficiency and reduce spending, or our sales and profitability can be affected if we have to reduce prices.
The integration of the pharmaceutical and healthcare industries may have a negative impact on our future revenue and operating income.
The pharmaceutical and medical technology industries have experienced a lot of integration.
Due to this integration, competition for goods and services for customers has intensified.
In addition, the group procurement organization and the integrated health services network have concentrated procurement decisions for some customers, which has put pricing pressure on suppliers.
Further integration of the industry we serve may put additional pressure on the price of our products.
We are regulated by governments around the world, and if we do not comply with these regulations, existing and future operations may be restricted and we may be held accountable.
The design, development, manufacture, marketing and labeling of certain products and products of our customers are all regulated by the US government authoritiesS.
Europe and other countries, including the FDA and the European drug administration.
Compliance with government regulations may be costly and may result in the necessary modification or withdrawal of existing products, as well as substantial delays in the launch of new products.
Failure to comply with applicable regulatory requirements or failure to obtain regulatory approvals for new products may result in costs and actions that may adversely affect our business and financial performance.
Products that contain our technology are subject to regulations and broad approvals or processes that make the new
Products that are difficult to predict are commercialized.
The process of obtaining FDA and other necessary regulatory approvals is very expensive and time-consumingconsuming.
Historically, most of the medical devices that contain our technology are subject to FDA 510 restrictions (k)
The marketing approval process usually lasts for 6 to 9 months.
Supplementary or complete pre-
A longer period of time is required for the market approval review, which has delayed the commercialisation.
Pharmaceutical products that combine our technology together will be subject to the FDA\'s new drug application process, which usually takes several years to complete.
In addition, biotechnology products containing our technology need to comply with the FDA\'s biological product license application process, which usually takes several years to complete.
Outside the United States. S.
Sales of medical devices and pharmaceutical or biotechnology products are subject to different international regulatory requirements in various countries.
The time required to obtain an international sales approval may be longer or shorter than the time required for FDA approval.
Changes in drug and device regulation may increase competitive pressure and adversely affect our business.
One effect of the government\'s regulation of our customers\' medicines, equipment and manufacturing processes is that compliance with regulations makes costs and time expensive
Consumers replace or replace components and equipment produced by another supplier with components and equipment produced by one supplier.
Over time, there has been an increase in the regulation of customer products that incorporate our components and equipment.
If the applicable regulations are to be modified to reduce the cost and time involved by the customer in replacing another supplier\'s components or equipment with one supplier\'s components or equipment, the competitive pressure may increase, and adversely affect our sales and profitability.
If we do not succeed in protecting intellectual property rights, our ability to compete can be compromised.
Our patents, trademarks and other intellectual property rights are very important to our business.
We rely on patents, trademarks, copyrights, trade secrets and other intellectual property laws, as well as NDA and other methods to protect our proprietary information, technology and processes.
We also have an obligationuse and non-
Disclosure of third-party intellectual property rights.
In order to enforce our intellectual property rights, protect our trade secrets, or determine the validity and scope of the ownership of others, we may need to carry out litigation or similar activities.
Any such litigation may require us to spend a lot of resources to divert the efforts and attention of management and other personnel from the operation of the business.
We cannot assure you what measures we will take to prevent theft, infringement or other infringement of our intellectual property rights or the intellectual property rights of others will be successful.
In addition, in some countries, some of our intellectual property rights may not be able or limited to obtain valid patent, copyright, trademark and trade secret protection.
Failure to protect our intellectual property rights may harm the results of our business and operations.
In addition, if the relevant and valid patent protection is not available or has expired, we may not prevent competitors from independently developing products and services similar to or duplicated with us.
Disruption to our production facilities may have a significant adverse impact on our ability to produce and sell products and have a negative impact on our reputation, performance or financial position.
We have production bases all over the world.
In addition, in some cases, the manufacturing of certain product lines is concentrated in one or more of our factories.
The operation of our manufacturing and distribution assets and systems may be interrupted due to reasons beyond our control, including: extreme weather or longer
Climate change;
Natural disasters; pandemic; war;
Accidental damage;
Interruption of supplies or services;
Product quality and safety issues;
System failure;
Employee action;
Or environmental pollution.
There is a risk that the existing accident management system may prove inadequate and any disruption may have a significant adverse effect on our ability to produce and sell products, so generate performance or financial status for our reputation.
The competition in the medical technology industry is very fierce, and customer demand and/or new products in the market may lead to a decrease in demand.
The medical technology industry is facing rapid technological change, and every market in our product line and product sales is facing huge competition.
We face competition from many companies.
These companies include large medical device companies, some of which have more financial and marketing resources than we do.
We also face competition from companies that are more professional than we are in a particular market.
In some cases, competitors, including pharmaceutical companies, also offer or attempt to develop alternative therapies for diseases that may be provided without medical equipment.
Other companies develop new or improved products, processes or technologies (such as needle-
Note-free technology
It may make some of our products or proposed products obsolete or less competitive.
In addition, failure to meet the growing quality expectations of customers can lead to a decrease in demand.
Our international sales and operations face risks and uncertainties that vary from country to country, which can have a significant adverse impact on our business and/or operational results.
We operate in most of the world\'s major pharmaceutical markets.
Our international business and ability to execute the overall business strategy (
Including our plans to continue to grow to emerging markets and/or faster --
Growing markets outside the United StatesS. )
Risks and uncertainties that may vary from country to country, including: transport delays and disruptions;
Political and economic instability and chaos;
Tariffs and tariffs;
Import and Export Control;
Risk of business expectations being different or culturally incompatible when establishing and maintaining business in foreign countries;
Difficulties in staffing and managing multiple aspects
National business;
Strike and/or dispute;
And potentially adverse tax consequences.
Our ability to enforce legal rights and remedies with third parties or our joint venture partners outside the United States is limitedS.
Exposure will also occur.
In addition, we may not be able to comply with foreign laws and regulations or with applicable customs, currency exchange control regulations, transfer pricing regulations or any other laws or regulations if they change, we may be bound by these laws or regulations.
Any of these events may adversely affect our future international business by reducing the demand for our products, reducing the price of our products sold, or adversely affect our financial position, operating results and cash flow.
Disruption of supply of key raw materials may adversely affect our operations.
We usually buy the raw materials and supplies needed to produce the products in the open market.
For quality assurance, single-source availability, or cost-effective reasons, many components and raw materials can only be obtained and/or purchased from a single supplier.
Due to the strict regulations and requirements of the FDA and other regulatory agencies for 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 costs.
Therefore, the reduction or interruption of manufacturing, or the inability to obtain alternative sources of raw materials or components, may have a significant adverse effect on our business and/or operational results.
Raw materials and energy prices have a significant impact on our profitability.
If raw materials and/or energy prices rise, we are unable to pass on these price increases to our customers, and our profitability and financial position may be affected.
We use three basic raw materials in product manufacturing: elastic body (
Including synthetic and natural materials)
Aluminum and plastic.
In addition, our manufacturing facilities consume a variety of energy products and provide fuel, heat and cooling for our operations.
Supply and demand factors that we cannot control often affect our raw material prices and utility costs.
If we cannot pass on the increased raw material prices and energy costs to our customers, our profitability, and therefore our financial position, may be adversely affected.
The prices of these raw materials and utilities are cyclical and volatile.
For example, the price of certain commodities, especially oil
In the recent period, materials based on raw materials have shown rapid changes, affecting the cost of synthetic rubber and plastics.
Although we usually try to pass the increased cost to our customers in the form of rising sales prices, historically, there is a time delay between rising raw material and/or energy prices and our ability to increase product prices.
In some cases, we may not be able to increase the price of the product due to competitive pressures and other factors.
If we are not timely or successful in new ways
Development and commercialisation of product innovation or proprietary multi-product
Our future income and operating income may be adversely affected.
Part of our growth depends on the new
Product innovation and the development and commercial of proprietary multi-product
Component Systems for injection drug management and other healthcare applications (
Such as Dajing CZ preparation-to-
Using a pre-filled syringe and SmartDose system).
Product development and commercialism are inherently uncertain and influenced by many factors beyond our control, including any necessary regulatory approvals and commercial acceptance of the product.
The final timing and successful commercialisation of new products and systems requires a substantive assessment of the functional, operational, clinical and economic viability of the company\'s products.
In addition, timely and adequate filling capacity is critical for the final stability test and the time when customer products are first commercialized in CZ pre-filled syringes.
DeLay, interruption or failure to develop and commercialize new products
Product innovation or proprietary
Component systems may adversely affect future revenue and operating revenue.
In addition, adverse conditions may also result in future charges for the recognition of impairment of the book value of our goodwill and other intangible assets, which may have a significant adverse effect on our financial results.
We may not be able to successfully locate and complete acquisitions or other strategic transactions (if any) that may adversely affect our business and operational results ).
We have been engaged in acquisition activities in the past and may be engaged in acquisitions or other strategic transactions in the future, such as joint ventures or investments in other entities.
We may not be able to identify the appropriate targets for future acquisitions or other strategic transactions, whether opportunistic or otherwise.
If we identify the right candidate, our ability to successfully implement strategic transactions will 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 agreement.
Strategic transactions involve risks, including those associated with integrated operations or individual maintenance operations (as applicable)
Financial reports, different technologies and personnel of the acquired company, joint venture or related company;
Manage business or other strategic investments that are geographically dispersed;
The attention of management shifts from other businesses;
The inherent risk of entering a market or business line where we have limited or no direct experience; unknown risks;
And potential losses to key employees, customers and strategic partners of acquired companies, joint ventures or companies that we may make strategic investments.
We may not successfully integrate any business or technology that we may acquire or strategically develop in the future, or we may not receive expected revenue and cost benefits related to any such strategic transaction.
Strategic deals can be expensive, time-consuming, and can run out of our resources.
Strategic transactions may not increase our revenue and may have a negative impact on our operating results due to the occurrence of debttime write-
Goodwill and amortization fees for other intangible assets.
In addition, the strategic transactions we may conduct may result in a diluted offering of equity securities.
Product defects may adversely affect our operating results.
There are certain inherent risks in the design, manufacture and marketing of medical devices.
Manufacturing or design defects, accidental use of our products or insufficient risk disclosure related to the use of our products may result in injury or other adverse events.
These events may result in a recall or security alert related to our products (
Similar government authorities in FDA or other countries voluntarily or request)
In some cases, the product may be removed from the market.
Recall can lead to huge costs, as well as negative publicity and damage to our reputation, which may reduce the demand for our products.
Personal injury related to the use of our products may also result in a claim for product liability against us.
In some cases, such adverse events may also result in delays in the approval of new products.
Our operations must comply with environmental regulations and regulations, and failure to comply may result in substantial costs that 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 we operate.
This puts us at risk of accidental pollution and non-pollution incidents in the past and in the future.
Comply with environmental laws.
Any such incident may result in regulatory enforcement or personal injury and property loss claims, or may result in the closure of some of our operations, which may adversely affect our business and operational results.
In order to comply with environmental laws and regulations, we will generate costs at the moment, which may become even greater.
The loss of key or highly skilled employees can disrupt our operations.
Our executives are critical to the management and direction of our business.
Our future success depends largely on our ability to retain these officers and other key employees, including those in technical, marketing, sales and research positions.
Competition can be intense for experienced employees, especially those with specialized skills.
Whether we can recruit such talents depends on various factors such as salary and benefits, work place, work environment, etc.
If we fail to recruit and retain qualified executives and employees effectively, our business may be adversely affected.
Although we believe that we will be able to attract and retain talent and replace key talent if needed, we cannot do so in a timely manner and may disrupt the operations of the affected units or our overall operations.
In addition, due to the complexity of many of our products and projects, we often rely on highly skilled engineers and Labor who are educated.
Our business may be interrupted by a lack of skilled staff.
The uncertain impact of potential climate change legislation could lead to a significant increase in costs.
If the United States enacted or enacted legislation or regulationsS.
Europe, Asia or any other jurisdiction in which we conduct business to limit or reduce permitted greenhouse gas emissions and other emissions that may have a significant impact on our operational and financial decisions, it includes capital spending to reduce emissions and the results of our operations.
If we fail to comply with new laws and regulatory regulations on climate change, our manufacturing business may not be able to operate as planned, or, operating in a profitable manner may become too expensive.
In addition, the increased costs of suppliers can be passed on to us at a higher price, and we may not be able to pass on these costs to our customers through price increases.
Federal health care reform may have a negative impact on our operational results.
The Patient Protection and Affordable Care Act (the “PPACA”)
Promulgated in March 2010.
PPACA reduces the amount of medical insurance and Medicaid paid to hospitals, clinical laboratories and pharmaceutical companies, otherwise it may reduce the number of medical procedures.
These factors, in turn, may lead to a decrease in demand for our products and an increase in pressure on prices to decline.
PPACA also has the potential to lead to reduced reimbursement of our customer products.
Although PPACA aims to expand health insurance coverage for uninsured people in the United StatesS.
At this time, the impact of any overall increase in access to health care on sales of Western products is uncertain.
To a certain extent, our sales depend on the extent to which government authorities, private insurance companies and other third-party agencies have reported the marketing of pharmaceutical companies and healthcare providers and facilities.
The payer of the cost of our products.
Third coverage policy and level of reimbursement
Payers from different public and private sources may affect the products purchased by customers and the prices they are willing to pay for them in specific jurisdictions.
Legislative or administrative reform of the US reimbursement systemS. (
As part of PPACA)or abroad (
For example, the issues under consideration by France, Germany, Italy and the United Kingdom)
Can greatly reduce the reimbursement of customer products, thereby reducing the demand for our products.
In addition, additional changes may occur in government health care programs over the next few years, which may have a significant impact on the success of our products.
We will continue to evaluate the revised PPACA, the implementation by federal agencies of regulations or guidance relating to the provisions of the PPACA, and trends and changes that may be encouraged by legislation, these trends and changes may affect our business over time.
There is no guarantee that we will continue to pay or declare dividends.
We have always paid dividends.
However, we cannot guarantee that dividends will be paid or declared in the future.
The actual declaration and payment of future dividends, the amount of any such dividend, and the establishment of the date of record and payment, if any, our board of directors, after reviewing our circumstances at the time, make decisions every quarter.
Current strategy, applicable debt covenants and financial performance and positions, among other things.
The declaration and payment of our future dividends are affected by risks and uncertainties, including: deterioration of our financial performance or condition;
Dividends cannot be declared in accordance with applicable law or a deed of debt;
An increase in our cash demand or a decrease in available cash;
The board\'s business judgment is that it is not in the best interest of the company to declare a dividend.
The results of our operations and earnings may not meet the guidance or expectations.
We provide public guidance on expected operational results for future periods.
This guide consists of the following:
Forward-looking statements affected by risks and uncertainties, including the risks and uncertainties described in table 10
In our other public documents and public statements, this is necessarily based on the assumptions we make in providing such guidance.
Our guidance may not always be accurate.
If in the future, the results of our operations in a particular period do not meet the expectations of our guidance or investment analysts, or we reduce guidance for future periods, the market price of our common stock may fall sharply.
We face the credit risk of accounts receivable and certain advances in the normal business process.
This risk increases during periods of deteriorating economic conditions.
Most of our outstanding trade receivables are not included in collateral or credit insurance.
In addition, we have made advance payments in relation to insurance premiums and other advances in the normal course of business.
While we have procedures to monitor and limit the credit risk exposure of trade receivables and other current assets, there is no guarantee that these procedures will effectively limit our credit risk and avoid losses, this may have a significant adverse effect on our financial position and operating results.
Unauthorized access to information and systems from us or our customers may have a negative impact on our business.
We may face certain security threats, including threats to the secrecy, availability and integrity of our data and systems.
To address these threats, we maintain a broad network of technology security controls, policy enforcement mechanisms, and monitoring systems.
While these measures are intended to prevent, detect and respond to unauthorized activities in our system, certain types of attacks may result in financial or information loss and/or reputation damage.
If we cannot prevent unauthorized access, release and/or damage to Confidential, confidential or personally identifiable information of us or our customers, our reputation may be compromised, we may face economic losses.
If we fail to comply with our obligations under the distribution or agreement with the greater education, or we are unable to renew these agreements in accordance with the same or substantially similar terms, we may lose licensing rights that are important to our business. Key value-
Licensing of ADD and proprietary products and processes to our affiliates, including, but not limited to, daikon CZ, FluroTec and B2-
Coating technology.
Our rights to these products and processes are licensed under agreements that expire on 2017 and we would like to renew them before they expire.
However, if we fail to renew these agreements, or terminate them early because we fail to meet our obligations, our business may be adversely affected. ITEM IB.
Staff comments that were not resolved as of the submission of this Form 10-
K, there are no unresolved comments from SEC staff. 16 ITEM 2.
Our company is based at Herman O 530.
West Exton Avenue, Pennsylvania.
The building also has sales and marketing, administrative support and customer service functions and laboratories in North America.
The following table summarizes production facilities by market segment and geographical area.
All displayed facilities are owned, unless otherwise indicated.
Packaging System Manufacturing: North American business European business Asia Pacific business United States Denmark China Clearwater, FL Horsens Qingpu Jersey coast, PA England India corny, NE St
Lititz, Singapore, parle nuvawyn Julong Street.
Peterborough, Florida (1)
Eschweiler, Germany (1)
Covan mould, Sao Paulo, Serbia, Brazil-South America businessand-
Mold tool store: Contract Analysis Laboratory: North America operates Europe operates North America operates the United States, the United States and the United States, PA Bodmin (2)
Manufacturing of delivery system: North American business Europe business Frankfurt, France, USA (2)Le Vaudreuil (2)
Phoenix, AZ (Grand Rapids, MI Ireland)2)Dublin (2)
Scottsdale, AZ (2)(3)Tempe, AZ (2)
William Sport, PA, Puerto Rico (1)
The manufacturing facility is also used for R & D activities. (2)
The facility is leased in whole or in part. (3)
The manufacturing facility is also used for mold and mold production.
Our delivery systems division leases facilities located in Israel, New Jersey and Texas for R & D and other activities.
The sales offices of each location are rented by short rent
Semester arrangements.
On October 2014, we announced plans to expand our global manufacturing business, including a new factory in Watford, Ireland, which will be used for insulin syringe cartridges and other high
Value of packaging parts.
Construction began in July 2015. ITEM 3.
No legal action. ITEM 4.
Mine safety information disclosure is not applicable.
Executive Officers of the company This table lists the executive officers of the company.
The executive officer is elected by the board of directors every year at the regular meeting of the board of directors after the annual meeting of shareholders.
Michael.
Anderson 60 vice president and treasurer since June 2001.
He served as chief financial officer of drug delivery systems from October 1999 to June 2001, vice president of business development from April 1997 to October 1999, and tax director from July 1992 to April 1997.
Warwick Bedwell 56 has served as president of pharmaceutical packaging systems in the Asia Pacific region since January 3, 2011.
Previously, he served as vice president and business director-
Bone and rheumatism of Roche Products (UK)
Limited, a biotechnology company, from October 2008 to August 2010.
From January 2007 to October 2008 he served as vice president and head of global business development at Hoffman larochi(U. S. )
From June 2003 to December 2006, he served as president and general manager of Roche.
In the Philippines.
Prior to that, he held multiple positions in the commercial operations of Roche Products Co. , Ltd. in Australia. Annette F.
He has served as senior vice president and chief human resources officer since October 2015.
Prior to joining West, she held strategic and global HR positions at IBM Corporation, an information technology services company, for more than 25 years.
Recently, she served as vice president of global talent management. William J.
Federici 56 has served as senior vice president and chief financial officer since joining the company in August 2003.
He served as the National Industry director of KPMG Pharma (Accounting firm
From June 2002 to August 2003, prior to this, it was an audit partner of andashin law firm. Karen A.
Flynn 53 has served as president of pharmaceutical packaging systems since October 2014.