UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended April 2, 2016
Commission file number 001-14041
HAEMONETICS CORPORATION
(Exact name of registrant as specified in its charter)
Massachusetts | 04-2882273 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
400 Wood Road, Braintree, Massachusetts 02184-9114 (Address of principal executive offices) | (781) 848-7100 (Registrant’s telephone number) | |
Securities registered pursuant to Section 12(b) of the Act:
(Title of Each Class) | (Name of Exchange on Which Registered) | |
Common stock, $.01 par value per share | New York Stock Exchange | |
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark whether 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 whether the registrant is not required to file reports pursuant to Section 13 or 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) (2.) has been subject to the filing requirements for at least 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 (§ 232.405 of this chapter) 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. þ
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. (Check one):
Large accelerated filer þ | Accelerated filer o | Non-accelerated filer o | Smaller reporting company o | |||
(Do not check if a smaller reporting company) | ||||||
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 and non-voting common equity held by non-affiliates of the registrant (assuming for these purposes that all executive officers and directors are “affiliates” of the registrant) as of September 26, 2015, the last business day of the registrant’s most recently completed second fiscal quarter was $1,738,830,869 (based on the closing sale price of the registrant’s common stock on that date as reported on the New York Stock Exchange).
The number of shares of $0.01 par value common stock outstanding as of May 20, 2016 was 51,042,696.
Documents Incorporated By Reference
Portions of the definitive proxy statement for our Annual Meeting of Shareholders to be held on July 21, 2016 are incorporated by reference in Part III of this report.
TABLE OF CONTENTS
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ITEM 1. BUSINESS
Company Overview
Haemonetics is a global healthcare company dedicated to providing innovative products to customers involved in the processing, handling and analysis of blood. We offer a comprehensive portfolio of integrated devices and information management tools with the goal of helping improve clinical outcomes and reduce costs for blood and plasma collectors, hospitals, and patients around the world. When used in this report, the terms “we,” “us,” “our” and “the Company” mean Haemonetics.
Haemonetics was founded in 1971 as a medical device company — a pioneer and market leader in developing and manufacturing automated blood component collection devices and surgical blood salvage devices. In May 1991, we completed an initial public offering and to this day remain an independent company.
Blood and its components (plasma, platelets, and red cells) have many vital - and frequently life-saving - clinical applications. Plasma is used for patients with major blood loss and is manufactured into pharmaceuticals to treat a variety of illnesses and hereditary disorders such as hemophilia. Red cells treat trauma patients or patients undergoing surgery with high blood loss, such as open heart surgery or organ transplant. Platelets treat cancer patients undergoing chemotherapy. Blood is essential to a modern healthcare system.
Haemonetics develops and markets a wide range of devices and solutions to serve our customers. We provide plasma collection systems and software which enable plasma fractionators to make life saving pharmaceuticals. We provide analytical devices for measuring hemostasis which enable healthcare providers to better manage their patients’ bleeding risk. Haemonetics makes blood processing systems and software which make blood donation more efficient and track life giving blood components. Finally, Haemonetics supplies systems and software which facilitate blood transfusions and cell processing.
Market and Products
Product Lines
We recently undertook a global strategic review of our business portfolio to identify which end markets and product franchises have the strongest growth opportunities. As a result of that review, we organized our current products into four franchises for purposes of evaluating their growth potential: Plasma, Hemostasis Management, Donor and Cell Processing. In that review, “Plasma” included plasma collection devices and disposables, plasma donor management software and anticoagulant and saline sold to plasma customers. “Hemostasis Management” included devices and methodologies for measuring coagulation characteristics of blood, such as our TEG® Hemostasis Analyzer. “Donor” included blood collection and processing devices and disposables for red cells, platelets and whole blood as well as related donor management software. “Cell Processing” included surgical blood salvage systems, specialized blood cell processing systems, disposables and blood transfusion management software.
In connection with this strategic review, we concluded that Plasma and Hemostasis Management have the greatest growth potential, while Cell Processing innovation offers an opportunity to increase market share and expand into new segments. Donor is competing in challenging markets which require us to manage the business differently, including reducing costs and the scope of the current product line. In recognition of these conclusions, we have begun to implement an operating model that will streamline the management structure and rationalize our cost structure, with an aim to bring about sustainable productivity improvement across the organization. Overall, we expect implementation of our new direction will require multiple changes and will extend beyond fiscal 2017.
To provide continuity while we are implementing these changes to our business approach, we are reporting our results consistent with how management viewed the business in fiscal 2016 and prior periods. In those periods, we viewed our company as serving three customer groups: manufacturers of plasma derived pharmaceuticals, blood collectors, and hospitals. In fiscal 2016 and previous periods included within this Annual Report on Form 10-K, we have reported revenues for multiple product lines under four global product categories: Plasma, Blood Center, Hospital, and Software Solutions.
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In these results, “Plasma” includes plasma collection devices and disposables. “Blood Center” includes blood collection and processing devices and disposables. “Hospital” includes surgical blood salvage and blood demand diagnostic devices and disposables. “Software Solutions” includes information technology platforms and consulting services provided to all three markets. Although we address our customers' needs through multiple product lines, we manage our business as five operating segments based primarily on geography: (a) North America Plasma, (b) Americas Blood Center and Hospital, (c) Europe, Middle East and Africa (collectively "EMEA"), (d) Asia Pacific and (e) Japan. The North America Plasma reporting unit is a separate operating segment with dedicated segment management due the size and scale of the plasma business.
For financial reporting purposes, we aggregate our five operating segments into four reportable segments which include:
• | Japan |
• | EMEA |
• | North America Plasma |
• | All Other |
We have aggregated the following two operating segments into the All Other reportable segment based upon their similar operational and economic characteristics, including similarity of operating margin:
• | Americas Blood Center and Hospital |
• | Asia - Pacific |
Segment Assets
Our assets by segment are set forth below:
(In thousands) | April 2, 2016 | March 28, 2015 | March 29, 2014 | ||||||||
Japan | $ | 129,551 | $ | 146,765 | $ | 159,227 | |||||
EMEA | 249,504 | 305,540 | 329,316 | ||||||||
North America Plasma | 453,212 | 467,249 | 421,706 | ||||||||
All Other | 486,861 | 565,863 | 603,929 | ||||||||
Total assets | $ | 1,319,128 | $ | 1,485,417 | $ | 1,514,178 | |||||
The financial information required for segments is included herein in Note 14, Segment Information, to our consolidated financial statements contained in Item 8 of this Annual Report on Form 10-K.
• | Plasma |
The Plasma Collection Market for Fractionation — Human plasma is collected and processed by bio-pharmaceutical companies into therapeutic and diagnostic products that aid in the treatment of immune diseases and coagulation disorders. While plasma is also used to aid patients with extreme blood loss, such as trauma victims, bio-pharmaceutical companies solely focus on plasma's pharmaceutical uses. Automated plasma collection technology allows for the safe and efficient collection of plasma. We manufacture and market automated plasma collection devices and respective disposables, but do not make plasma-derived pharmaceuticals.
Many bio-pharmaceutical companies are vertically integrated in all components of their business and thus are now collecting and fractionating the plasma required to manufacture pharmaceuticals. This vertical integration paved the way for highly efficient plasma supply chain management and the plasma industry leverages information technology to manage operations from the point of plasma donation to fractionation to the production of the final product.
Haemonetics' Plasma Products — Our portfolio of products and services is designed to support multiple facets of plasma collector operations. We have a long-standing commitment to understanding our customers' collection and fractionation processes. As a result, we deliver product quality and reliability; design equipment that is durable, dependable, and easy to use; comprehensive training and support, and strong business continuity practices.
Historically, plasma for fractionation was collected manually, which was time-consuming, labor-intensive, produced relatively poor yields, and posed risk to donors. Today, the vast majority of plasma collections worldwide are performed using automated collection technology because it is safer and more cost-effective. With our PCS® brand automated plasma collection technology, more plasma can be collected during any one donation event because the other blood components are returned to the donor through the sterile disposable sets used for the plasma donation procedure.
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We offer “one stop shopping” to our plasma collection customers, enabling them to source from us the full range of products necessary for plasma collection and storage, including PCS® brand plasma collection equipment and disposables, plasma collection containers, and intravenous solutions such as saline. We also offer a robust portfolio of integrated information technology platforms for plasma customers to manage their donors, operations, and supply chain. Our products automate the donor interview and qualification process; streamline the workflow process in the plasma center; provide the controls necessary to evaluate donor suitability; determine the ability to release units collected; and manage unit distribution. With our software solutions, plasma collectors can manage processes across the plasma supply chain, react quickly to business changes, and identify opportunities to reduce costs.
Our plasma disposables product line represented 38.4%, 35.1%, and 31.1% of our total revenue in fiscal 2016, 2015 and 2014, respectively.
• | Blood Center |
The Blood Collection Market for Transfusion — There are millions of blood donations throughout the world every year that produce blood products for transfusion to surgical, trauma, or chronically ill patients. Patients typically receive only the blood components necessary to treat a particular clinical condition: for example, red cells to surgical patients, platelets to cancer patients, and plasma to trauma victims.
Platelet therapy is frequently used to alleviate the effects of chemotherapy and help patients with bleeding disorders. Red cells are often transfused to patients to replace blood lost during surgery. Red cells are also transfused to patients with blood disorders, such as sickle cell anemia or aplastic anemia. Plasma, in addition to its role in creating life-saving pharmaceuticals, is frequently transfused to trauma victims and to replace blood volume lost during surgery.
The demand for blood components varies across the world. While overall we expect total demand to remain stable, demand in individual markets can vary greatly. Highly populated emerging market countries are seeing demand growth as they expand healthcare coverage. As greater numbers of people gain access to more advanced medical treatment, demand for blood components, plasma-derived drugs, and surgical procedures increases. In more mature markets, the development of less invasive, lower blood loss procedures and better blood management has offset the demand increases from aging populations. This is particularly true in the United States, where we saw collections decline by approximately 10% in fiscal 2015 and 7% in fiscal 2016. We expect further declines in fiscal 2017.
Most donations worldwide are manual whole blood donations. In this process, whole blood is collected from the donor and then transported to a laboratory where it is separated into its components: red cells, platelets and/or plasma.
In addition to manual collections, there is a significant market for automated component blood collections. In this procedure, the blood separation process is automated and occurs in “real-time” while a person is donating blood. In this separation method, only the specific blood component targeted is collected, and the remaining components are returned to the blood donor. Automated blood component collection allows significantly more of the targeted blood component to be collected during a donation event, especially red cells where our automated system supports collection of two units from eligible donors.
Haemonetics’ Blood Center Products — Today, Haemonetics offers automated blood component and manual whole blood collection systems to blood collection centers to collect blood products efficiently and cost effectively.
We market the MCS® (Multicomponent Collection System) brand apheresis equipment which is designed to collect specific blood components integrated from the donor. Utilizing the MCS® automated platelet collection protocols, blood centers collect one or more therapeutic “doses” of platelets during a single donation. The MCS® two-unit protocol or double red cell collection device helps blood collectors optimize the collection of red cells by automating the blood separation function, eliminating the need for laboratory processing, and enabling the collection of two units of red cells from a single donor thus maximizing the amount of red cells collected per eligible donor and helping to mitigate red cell shortages in countries where this problem exists. Blood collectors can also use the MCS® system to collect one unit of red cells and a "jumbo" (double) unit of plasma, or one unit of red cells and one unit of platelets from a single donor. The MCS® plasma protocol, which provides the possibility of collecting 600-800ml of plasma for either transfusion to patients or for use by the pharmaceutical industry, completes the comprehensive portfolio of different blood component collection options on this device.
Haemonetics also offers a portfolio of products for manual whole blood collection and processing. Haemonetics' portfolio of disposable whole blood collection and component storage sets offer flexibility in collecting a unit of whole
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blood and the subsequent production and storage of the red blood cell, platelet, and/or plasma products, including options for in-line or dockable filters for leukoreduction of any blood component.
With the ACP® (Automated Cell Processor) brand, Haemonetics offers a solution to automate the washing and freezing of red cell components. The automated red cell washing procedure removes plasma proteins within the red cell units to provide a safer product for transfusion to frequently transfused patients, neonates, or patients with a history of transfusion reactions. The automated glycerolization and deglycerolization steps are required to prepare red cells for frozen storage. Freezing the red cell units can expand the shelf life of these products up to 10 years. Customers utilize this technology to implement strategic red cell inventories for catastrophe cases, storage of rare blood types, or enhanced inventory management.
Our blood center disposables product line represented 34.2%, 37.3%, and 41.5% of our total revenue in fiscal 2016, 2015 and 2014, respectively.
• | Hospital |
The Transfusion Market for Hospitals — Loss of blood is common in many surgical procedures, including open heart, trauma, transplant, vascular, and orthopedic procedures, and the need for transfusion of oxygen-carrying red cells to make up for lost blood volume is routine. Patients commonly receive donor blood, referred to as “allogeneic blood,” which carries various risks including risk of transfusion with the wrong blood type; risk of transfusion reactions including death, but more commonly chills, fevers or other side effects that can prolong a patient’s recovery; and risk of transfusion of blood with a blood-borne disease or infectious agent.
An alternative to allogeneic blood is surgical cell salvage, also known as autotransfusion, which reduces or eliminates a patient’s need for blood donated from others and ensures that the patient receives the freshest and safest blood possible — his or her own. Surgical cell salvage involves the collection of a patient’s own blood during and after surgery, for reinfusion of red cells to that patient. Blood is suctioned from the surgical site or collected from a wound or chest drain, processed and washed through a centrifuge-based system that yields concentrated red cells available for transfusion back to the patient. This process occurs in a sterile, closed-circuit, single-use consumable set that is fitted into an electromechanical device. We market our surgical blood salvage products to surgical specialists, primarily cardiovascular, orthopedic, and trauma surgeons, and to surgical suite service providers.
Blood loss also has profound implications for a patient’s hemostasis or ability to effectively produce clots without causing thrombosis. Hemostasis management plays a role in various medical procedures including: liver transplant, cardiovascular procedures, trauma and percutaneous coronary intervention (PCI). By understanding a patient’s clotting ability, clinicians can better plan for the patient’s care, deciding in advance whether to start or discontinue use of certain drugs or, determine the likelihood of the patient's need for a transfusion and which blood components will be most effective in stopping bleeding. Such planning supports better care, which can lead to lower hospital costs through a reduction in unnecessary donor blood transfusions, reduced adverse transfusion reactions, and shorter intensive care unit and hospital stays. We market our hemostasis analyzers to hospitals and laboratories as an alternative to less comprehensive blood tests.
Haemonetics’ Hospital Products — Haemonetics offers a range of blood management solutions that improve a hospital's systems for acquiring blood, storing it in the hospital, and dispensing it efficiently and correctly. Over the last few years, hospitals have become increasingly aware of their need to control costs and improve patient safety by managing blood more effectively. Our products and integrated solution platforms help hospitals optimize performance of blood acquisition, storage, and distribution.
The TEG® Thrombelastograph Hemostasis Analyzer system is a blood diagnostic instrument that measures a patient's hemostasis, the ability to form and maintain blood clots. Haemonetics acquired Haemoscope Corporation and the TEG 5000 technology in 2007 and now exclusively licenses the TEG 6s technology in the hospital and labs market from Cora Healthcare, Inc., a company established by the founders of Haemoscope. We have launched the TEG 6s in certain markets in Europe and Asia. During fiscal 2016, the TEG 6s received final 510(k) clearance from the FDA in North America, our largest market for TEG, for the indications of cardiovascular surgery and cardiology procedures allowing us to launch the product in those markets.
The Cell Saver® system is a surgical blood salvage system targeted to procedures that involve rapid, high-volume blood loss, such as cardiovascular surgeries. It has become the standard of care for high blood-loss surgeries. In fiscal 2012, we launched the Cell Saver® Elite® system, which is our most advanced autotransfusion option to minimize allogeneic blood use for surgeries with medium to high blood loss.
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The OrthoPAT® surgical blood salvage system is targeted to orthopedic procedures, such as hip and knee replacements, which involve slower, lower volume blood loss that often occurs well after surgery. The system is designed to remain with the patient following surgery, to recover blood and produce a washed red cell product for autotransfusion.
Our hospital disposables product line represented 13.7%, 13.7%, and 13.3% of our total revenue in fiscal 2016, 2015 and 2014, respectively.
• | Software Solutions |
Haemonetics' Software Products and Services — We have a suite of integrated software solutions for improving efficiencies and helping ensure donor and patient safety. This includes solutions for blood drive planning, donor recruitment and retention, blood collection, component manufacturing and distribution, transfusion management, and remote blood allocation. For our plasma customers, we also provide information technology platforms for managing donors and information associated with the collection of plasma products and their processing within fractionation facilities.
For our Hospital customers, our software products help hospitals track and safely deliver stored blood products. SafeTrace Tx® is our software solution that helps manage blood product inventory, perform patient cross-matching, and manage transfusions. In addition, our BloodTrack® suite of solutions manages tracking and control of blood products from the hospital blood center through to transfusion to the patient. “Smart” refrigerators located in or near operating suites, emergency rooms, and other parts of the hospital dispense blood units with secure control and automated traceability for efficient documentation.
For Blood Center customers, our software solutions span blood center operations and automate and track operations from the recruitment of the blood donor to the disposition of the blood product. Combined, our solutions help blood collectors improve the safety, regulatory compliance, and efficiency of blood collection and supply.
Our software solutions product line represented 8.0%, 7.9%, and 7.5% of our total revenue in fiscal 2016, 2015 and 2014, respectively.
Marketing/Sales/Distribution
We market and sell our products to bio-pharmaceutical companies, blood collection groups and independent blood centers, hospitals and hospital service providers, group purchasing organizations and national health organizations through our own direct sales force (including full-time sales representatives and clinical specialists) as well as independent distributors. Sales representatives target the primary decision-makers within each of those organizations.
United States
In fiscal 2016, 2015 and 2014 57.1%, 54.4%, and 53.4%, respectively, of consolidated net revenues were generated in the U.S., where we primarily use a direct sales force to sell our products. See Note 14, Segment Information, to our consolidated financial statements contained in Item 8 for additional information.
Outside the United States
In fiscal 2016, 2015 and 2014 42.9%, 45.6%, and 46.6%, respectively, of consolidated net revenues were generated through sales to non-U.S. customers. Outside the United States, we use a combination of direct sales force and distributors. See Note 14, Segment Information, to our consolidated financial statement contained in Item 8 for additional information.
Research and Development
Our research and development centers in the United States and Switzerland ensure that protocol variations are incorporated to closely match local customer requirements. In addition, Haemonetics maintains software development operations in Canada and France.
Customer collaborations are also an important part of our technical strength and competitive advantage. These collaborations with customers and transfusion experts provide us with ideas for new products and applications, enhanced protocols, and potential test sites as well as objective evaluations and expert opinions regarding technical and performance issues.
The development of blood component separation products and extracorporeal blood typing and screening systems has required us to maintain technical expertise in various engineering disciplines, including mechanical, electrical, software, and biomedical engineering and material science. Innovations resulting from these various engineering efforts enable us to develop systems that are faster, smaller, and more user-friendly, or that incorporate additional features important to our customer base.
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Research and development expense was $45.0 million in fiscal 2016, $54.2 million in fiscal 2015 and $54.2 million in fiscal 2014, representing approximately 5.0% - 6.0% of our net sales each year.
In fiscal 2016, research and development resources were allocated to supporting next generation plasma collection and software systems, a new TEG® Thrombelastograph Hemostasis Analyzer, and several other enhancements to our legacy product portfolios.
Manufacturing
Our principal manufacturing operations are located in the United States, Mexico, and Malaysia.
In fiscal 2016, we completed our Value Creation and Capture (“VCC”) opportunities initiative. This initiative included (i) discontinuation of manufacturing activities at our Ascoli-Piceno, Italy and Braintree, Massachusetts facilities, (ii) expansion of our current facility in Tijuana, Mexico, (iii) transfer of all equipment production to our contract manufacturer, Sanmina Corporation, and (iv) consolidation of the manufacturing of product formerly produced in the U.S. and Italy to our new manufacturing facility in Penang, Malaysia. We continue to manufacture in Bothwell, Scotland. Refer to Liquidity and Capital Resources within our Management's Discussion and Analysis of Financial Condition and Results of Operations contained in Item 7 of this Annual Report on Form 10-K for further discussion of the costs of these activities.
As part of our global strategic review, we continue to evaluate our manufacturing operations. Accordingly, we may make further changes to our manufacturing footprint based on future business conditions.
In general, our production activities occur in controlled settings or “clean room” environments. Each step of the manufacturing and assembly process is quality checked, qualified, and validated. Critical process steps and materials are documented to ensure that every unit is produced consistently and meets performance requirements. Our equipment and disposable manufacturing sites are certified to the ISO 13485 standard and to the Medical Device Directive allowing placement of the CE mark of conformity.
Plastics are the principal component of our disposable products. Contracts with our suppliers help mitigate some of the short-term effects of price volatility in this market. However, increases in the price of petroleum derivatives could result in corresponding increases in our costs to procure plastic raw materials.
Contractors manufacture some component sets and equipment according to our specifications. We maintain important relationships with two Japanese manufacturers that produce finished disposables in Singapore, Japan, and Thailand. We have also engaged Sanmina Corporation to be the sole manufacturer of certain equipment. Certain parts and components are purchased from sole source vendors. We believe that if necessary, alternative sources of supply are available in most cases, and could be secured within a relatively short period of time. Nevertheless, an interruption in supply could temporarily interfere with production schedules and affect our operations.
Our equipment is designed in-house and assembled by us or our contracted manufacturers from components that are manufactured to our specifications. The completed instruments are programmed, calibrated, and tested to ensure compliance with our engineering and quality assurance specifications. Inspection checks are conducted throughout the manufacturing process to verify proper assembly and functionality. When mechanical and electronic components are sourced from outside vendors, those vendors must meet detailed qualification and process control requirements.
Intellectual Property
We consider our intellectual property rights to be important to our business. We rely on patent, trademark, copyright, and trade secret laws, as well as provisions in our agreements with third parties, to protect our intellectual property rights. We hold patents in the United States and many international jurisdictions on some of our machines, processes, disposables and related technologies. These patents cover certain elements of our systems, including protocols employed in our equipment and certain aspects of our processing chambers and disposables. Our patents may cover current products, products in markets we plan to enter, or products in markets we plan to license, or the patents may be defensive in that they are directed to technologies not currently embodied in our current products. We may also license patent rights from third parties that cover technologies that we plan to use in our business. To maintain our competitive position, we rely on the technical expertise and know-how of our personnel and on our patent rights. We pursue an active and formal program of invention disclosure and patent application in both the United States and foreign jurisdictions. We own various trademarks that have been registered in the United States and certain other countries.
Our policy is to obtain patent and trademark rights in the U.S. and foreign countries where such rights are available and we believe it is commercially advantageous to do so. However, the standards for international protection of intellectual property
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vary widely. We cannot assure that pending patent and trademark applications will result in issued patents and registered trademarks, that patents issued to or licensed by us will not be challenged or circumvented by competitors, or that our patents will not be determined invalid.
Competition
To remain competitive, we must continue to develop and acquire new cost-effective products, information technology platforms, and business services. We believe that our ability to maintain a competitive advantage will continue to depend on a combination of factors. Some factors are largely within our control such as: (i) maintenance of a positive reputation among our customers, (ii) development of new products which meet our customer's needs, (iii) obtaining regulatory approvals for our products in key markets, (iv) obtaining patents which protect our innovations, (v) development and protection of proprietary know-how in important technological areas, (vi) product quality, safety and cost effectiveness and (vii) continual and rigorous documentation of clinical performance. Other factors are outside of our control. We could see changes in regulatory standards or clinical practice which favor a competitor's technology or reduce revenues in key areas of our business.
In addition, we face competition from several large, global companies with product offerings similar to ours, such as Terumo BCT, LivaNova Plc and Fresenius SE & Co. KGaA. Terumo and Fresenius, in particular, have significantly greater financial and other resources than we do and are strong competitors in a number of our businesses. The following provides an overview of the key competitors in each of our four global product enterprises.
• | Plasma |
In the automated plasma collection market, we principally compete with the Kabi division of Fresenius, which acquired Fenwal, Inc. in November 2012, on the basis of quality, reliability, ease of use, services and technical features of the collection systems, and on the long-term cost-effectiveness of equipment and disposables. In China, the market is populated by local producers of a product that is intended to be similar to ours. Recently, those competitors have expanded to markets beyond China, into European and South American countries. In the field of Plasma related software, MAK Systems is the primary commercial competitor along with applications developed internally by our customers.
• | Blood Center |
We have several competitors in the Blood Center product lines, some of which compete across all blood components and others that are more specialized.
Terumo BCT, and Fresenius are our major competitors in platelet collection. In platelet collections, there are two areas of competition - automated collection and pooled random donor. In the automated collection area, competition is based on continual performance improvement, as measured by the time and efficiency of platelet collection and the quality of the platelets collected. Each of these companies has taken a different technological approach in designing their systems for automated platelet collection. In addition to automated platelet collection offerings, we now also compete in the pooled random donor platelet segment from whole blood collections from which pooled platelets are derived with the Acrodose product or buffy coat pooling sets.
Terumo BCT and Fresenius are also competitors in the automated red cell collection market. However, it is important to note that most double red cell collection is done in the U.S. and less than 10% of the red cells collected in the U.S. annually are collected via automation. Therefore, we also compete with the traditional method of collecting red cells from the manual collection of whole blood. We compete on the basis of total cost, type-specific collection, process control, product quality, and inventory management.
Our whole blood business faces intense competition on the basis of quality and price. In North America, Europe and Asia-Pacific our main competitors are Fresenius, MacoPharma and Terumo BCT. We do not have significant whole blood revenues in Japan today.
In Donor software, Sunquest Information Systems is a competitor along with systems developed internally by our customers.
The competition for processing cells for storage is based on the level of automation, labor-intensiveness, and system type (open versus closed). Open systems may be weaker in good manufacturing process compliance. Moreover, blood processed through open systems has a 24-hour shelf life. With the ACP® (automated cell processor) brand, Haemonetics offers a closed system cell processor which gives blood processed through it, a 14-day shelf life. We compete with Terumo BCT's open systems in this market.
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• | Hospital |
The TEG Thrombelastograph Hemostasis Analyzer is used primarily in surgical applications. ROTEM is a direct competitor in Europe and in the United States. Other competitive technologies include standard coagulation tests and platelet function testing. The TEG analyzer competes with other laboratory tests based on its ability to provide a complete picture of a patient's hemostasis at a single point in time, and the ability to measure the clinically relevant platelet function for an individual patient.
In the intraoperative surgical blood salvage market, competition is based on reliability, ease of use, service, support, and price. For high-volume platforms, each manufacturer's technology is similar, and our Cell Saver technology competes principally with LivaNova Plc, Medtronic, and Fresenius.
In the perioperative surgical blood salvage market, our OrthoPAT system competes primarily against (i) non-automated processing systems whose end product is an unwashed red blood cell unit for transfusion to the patient, (ii) transfusions of donated blood and (iii) coagulation therapies such as tranexamic acid.
• | Software Solution |
In the software market, we compete with MAK Systems, Mediware, Sunquest Information Systems and applications developed internally by our customers. These companies provide software to blood and plasma collectors and to hospitals for managing donors, collections, and blood units. None of these companies competes with Haemonetics' non-software products.
Our technical staff is highly skilled, but certain competitors have substantially greater financial resources and larger technical staffing at their disposal. There can be no assurance that competitors will not direct substantial efforts and resources toward the development and marketing of products competitive with those of Haemonetics.
Significant Customers
There were no customers that accounted for greater than 10% of our net revenues in fiscal 2016, fiscal 2015, or fiscal 2014.
Government Regulation
Medical Device Regulation
The products we manufacture and market are subject to regulation by the Center of Biologics Evaluation and Research (“CBER”), Center for Devices and Radiological Health (“CDRH”) and the Center for Drug Evaluation and Research ("CDER") of the United States Food and Drug Administration (“FDA”), and other non-United States regulatory bodies.
All medical devices introduced to the United States market since 1976 are required by the FDA, as a condition of marketing, to secure either a 510(k) pre-market notification clearance or an approved premarket approval application (“PMA”). In the United States, software used to automate blood center operations and blood collections and to track those components through the system are considered by the FDA to be medical devices, subject to 510(k) pre-market notification. Intravenous solutions (blood anticoagulants and solutions for storage of red blood cells) marketed by us for use with our manual collection and automated systems requires us to obtain an approved New Drug Application (“NDA”) or Abbreviated New Drug Application (“ANDA”) from CBER or CDER. A 510(k) pre-market clearance indicates the FDA’s agreement with an applicant’s determination that the product for which clearance is sought is substantially equivalent to another legally marketed medical device. The process of obtaining a 510(k) clearance may involve the submission of clinical data and supporting information. The process of obtaining an NDA approval for solutions is likely to take much longer than 510(k) clearances because the FDA review process is more complicated.
The FDA’s Quality System regulations sets forth standards for our product design and manufacturing processes, requires the maintenance of certain records and provides for inspections of our facilities. There are also certain requirements of state, local and foreign governments that must be complied with in the manufacturing and marketing of our products. We maintain customer complaint files, record all lot numbers of disposable products, and conduct periodic audits to assure compliance with all regulations. We place special emphasis on customer training and advise all customers that device operation should be undertaken only by qualified personnel.
The FDA can ban certain medical devices; detain or seize adulterated or misbranded medical devices; order repair, replacement or refund of these devices; and require notification of health professionals and others with regard to medical devices that present unreasonable risks of substantial harm to the public health. The FDA may also enjoin and restrain certain violations of
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the Food, Drug and Cosmetic Act and the Safe Medical Devices Act pertaining to medical devices, or initiate action for criminal prosecution of such violations.
We are also subject to regulation in the countries outside the United States in which we market our products. The member states of the European Union (EU) have adopted the European Medical Device Directive, which creates a single set of medical device regulations for all EU member countries. These regulations require companies that wish to manufacture and distribute medical devices in EU member countries to obtain CE Marking for their products. Outside of the EU, many of the regulations applicable to our products are similar to those of the FDA. However, the national health or social security organizations of certain countries require our products to be registered by those countries before they can be marketed in those countries.
We have complied with these regulations and have obtained such registrations where we market our products. Federal, state and foreign regulations regarding the manufacture and sale of products such as ours are subject to change. We cannot predict what impact, if any, such changes might have on our business.
Conflict Minerals
The Dodd-Frank Wall Street Reform and Consumer Protection Act imposes disclosure requirements regarding the use of "Conflict Minerals" mined from the Democratic Republic of Congo and adjoining countries in products, whether or not these products are manufactured by third parties. The conflict minerals include tin, tantalum, tungsten and gold, and their derivatives. These requirements could affect the pricing, sourcing and availability of minerals used in the manufacture of our products. There will be additional costs associated with complying with the disclosure requirements, such as costs related to determining the source of any conflict minerals used in our products. Our supply chain is complex and we may be unable to verify the origins for all metals used in our products.
Other Regulation
We are also subject to various environmental, health and general safety laws, directives and regulations both in the U.S. and abroad. Our operations, like those of other medical device companies, involve the use of substances regulated under environmental laws, primarily in manufacturing and sterilization processes. We believe that sound environmental, health and safety performance contributes to our competitive strength while benefiting our customers, shareholders and employees.
Environmental Matters
Failure to comply with international, federal and local environmental protection laws or regulations could have an adverse impact on our business or could require material capital expenditures. We continue to monitor changes in U.S. and international environmental regulations that may present a significant risk to the business, including laws or regulations relating to the manufacture or sale of products using plastics.
Employees
As of April 2, 2016, we employed the full-time equivalent of 3,225 persons assigned to the following functional areas: manufacturing, 1,845; sales and marketing, 688; general and administrative, 258; research and development, 186; and quality control and field service, 248.
Availability of Reports and Other Information
All of our corporate governance materials, including the Principles of Corporate Governance, the Business Conduct Policy and the charters of the Audit, Compensation, and Nominating and Governance Committees are published on the Investor Relations section of our website at http://phx.corporate-ir.net/phoenix.zhtml?c=72118&p=irol-IRHome. On this web site the public can also access, free of charge, our annual, quarterly and current reports and other documents filed or furnished to the Securities and Exchange Commission, or SEC, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
Cautionary Statement Regarding Forward-Looking Information
Statements contained in this report, as well as oral statements we make which are prefaced with the words “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “designed,” and similar expressions, are intended to identify forward looking statements regarding events, conditions, and financial trends that may affect our future plans of operations, business strategy, results of operations, and financial position. These statements are based on our current expectations and estimates as to prospective events and circumstances about which we can give no firm assurance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made. As it is not possible to
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predict every new factor that may emerge, forward-looking statements should not be relied upon as a prediction of our actual future financial condition or results.
These forward-looking statements, like any forward-looking statements, involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated, including: the effects of disruption from the manufacturing transformation making it more difficult to maintain relationships with employees and timely deliver high quality products, changes in executive management, changes in operations as a result of our global strategic review, asset revaluations to reflect current business conditions, technological advances in the medical field and standards for transfusion medicine and our ability to successfully implement products that incorporate such advances and standards, demand for whole blood and blood components, product quality, market acceptance, regulatory uncertainties, including the receipt or timing of regulatory approvals, the effect of economic and political conditions, the impact of competitive products and pricing, blood product reimbursement policies and practices, foreign currency exchange rates, changes in customers’ ordering patterns including single-source tenders, the effect of industry consolidation as seen in the plasma and blood center markets, the effect of communicable diseases and the effect of uncertainties in markets outside the U.S. (including Europe and Asia) in which we operate and other risks detailed under Item 1A. Risk Factors included in this report. The foregoing list should not be construed as exhaustive.
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ITEM 1A. RISK FACTORS
In addition to the other information contained in this Annual Report and the exhibits hereto, the following risk factors should be considered carefully in evaluating our business. Our business, financial condition, cash flows or results of operations could be materially adversely affected by any of these risks. This section contains forward-looking statements. You should refer to the explanation of the qualifications and limitations on forward-looking statements at the end of Item 1 and Item 7 of this Annual Report.
We recently completed a global strategic review of our business. If our new strategic direction does not yield the expected results or we fail to implement the necessary changes to our operations, we could see material adverse effects on our business, financial condition or results of operations.
We recently undertook a global strategic review of our business portfolio to identify which end markets and product franchises have the strongest growth opportunities. As a result of that review, we organized our current products into four franchises for purposes of evaluating their growth potential: Plasma, Hemostasis Management, Donor and Cell Processing. We concluded that Plasma and Hemostasis Management have the greatest growth potential, while Cell Processing innovation offers an opportunity to increase market share and expand into new segments. We believe Donor is competing in challenging markets which require us to manage the business differently, including reducing costs and the scope of the current product line.
If we have not correctly identified the franchises with greatest growth potential, we will not allocate our resources appropriately which will have a material adverse effect on our business, financial condition or results of operations. Further, if we are unable to reduce costs and complexity in our Donor franchise, we will obtain lower than expected cash flows to fund our future growth and capital needs. This could have a material adverse effect on our liquidity and results of operations.
If we are unable to successfully expand our product lines through internal research & development and acquisitions, our business may be materially and adversely affected.
Continued growth of our business depends on our maintaining a pipeline of profitable new products and successful improvements to our existing products. This requires accurate market analysis and carefully targeted application of intellectual and financial resources toward technological innovation or acquisition of new products. The creation and adoption of technological advances is only one step. We must also efficiently develop the technology into a product which confers a competitive advantage, represents a cost effective solution or provides improved patient care. Finally, as a part of the regulatory process of obtaining marketing clearance for new products, we conduct and participate in numerous clinical trials, the results of which may be unfavorable, or perceived as unfavorable by the market, and could have a material adverse effect on our business, financial condition or results of operations.
The risks of missteps and set backs are an inherent part of the innovation and development processes in the medical device industry.
If we are unable to successfully grow our business through business relationships and acquisitions, our business may be materially and adversely affected.
Promising partnerships and acquisitions may not be completed for reasons such as competition among prospective partners or buyers, our inability to reach satisfactory terms, or the need for regulatory approvals. Any acquisition that we complete may be dilutive to earnings and require the investment of significant resources. The economic environment may constrain our ability to access the capital needed for acquisitions and other capital investments.
A significant portion of our revenue derives from the sale of blood collection supplies. Declines in the number of blood collection procedures have adversely impacted our business and future declines may have an adverse effect on our business, financial condition and results of operations.
Sales to blood collectors represented 39.7% of our consolidated disposables revenues in fiscal 2016. In certain markets, changes in medical protocols and the development of less invasive, lower blood loss procedures has reduced the number of transfusions of red blood cells, which has in turn led to a decline in the number of blood collection procedures. This is particularly true in the United States where we saw collections decline by approximately 10% and 7% in fiscal 2015 and 2016, respectively. We expect this trend to continue further in fiscal 2017.
In response to this trend, certain large U.S. blood center collection groups pursued single source vendors for whole blood collection products which required significant reductions in average selling prices in order to retain or increase our share of their business. During fiscal 2014, we entered into a multi-year agreement to supply the HemeXcel Purchasing Alliance, LLC with certain whole blood collection components during the calendar years 2014-2016. The agreement included a reduction in average selling prices which was implemented at the end of first quarter of fiscal 2015. In March 2014, the American Red Cross selected another exclusive supplier to provide certain whole blood products. This reduced annualized revenues by approximately $25.0 million beginning in the second quarter of fiscal 2015.
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During the first half of fiscal 2016, the American Red Cross and two group purchasing organizations representing other U.S. blood collectors ("Blood Center GPOs") pursued arrangements for apheresis red cell collections. These negotiations have concluded and will negatively affect red cell revenues and gross margins, a negative impact of approximately $12 million is expected on fiscal 2017 operating income.
Consolidation of the healthcare providers and blood collectors has increased demand for price concessions and caused the exclusion of suppliers from significant market segments, which could have an adverse effect on our business, financial condition and results of operations.
Political, economic and policy influences are causing the healthcare and blood collection industries to make substantial structural and financial changes that will continue affecting our results of operations. Government and private sector initiatives limiting the growth of healthcare costs and causing healthcare delivery structure reforms, including the reduction in blood use reduced payments for care. These trends have placed greater pricing pressure on suppliers, decreased average selling prices and increased the number of sole source relationships. This pressure impacts our Hospital and Blood Center businesses.
The expansion among hospitals in the United States of group purchasing organizations, integrated delivery networks and large single accounts directly puts price pressure on our Hospital business. It also puts price pressure on our United States Blood Center customers who are also facing reduced demand for red cells. Our Blood Center customers have responded to this pressure by creating their own group purchasing organizations and resorting to single source tenders to create incentives for suppliers, including us, to significantly reduce prices.
We expect that market demand, government regulation, third-party reimbursement policies, government contracting requirements and societal pressures will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances among our customers and competitors. This may exert further downward pressure on the prices of our products and adversely impact our business, financial condition or results of operations.
Quality problems with our processes, goods, and services could harm our reputation for producing high-quality products and erode our competitive advantage, sales, and market share.
Quality is extremely important to us and our customers due to the serious and costly consequences of product failure. Our quality certifications are critical to the marketing success of our products and services. If we fail to meet these standards or fail to adapt to evolving standards, our reputation could be damaged, we could lose customers, and our revenue and results of operations could decline.
As approximately half of our revenue comes from outside the United States, we are subject to currency fluctuation, geopolitical risk, economic volatility, anti-corruption laws, export and import restrictions, local regulatory authorities and the laws and medical practices in foreign jurisdictions.
We do business in over 100 countries and have distributors in approximately 90 countries. This exposes us to currency fluctuation, geopolitical risk, economic volatility, anti-corruption laws, export and import restrictions, local regulatory authorities and the laws and medical practices in foreign jurisdictions.
If there are sanctions or restrictions on the flow of capital which prevent product importation or receipt of payments in Russia or China, our business could be adversely affected.
Our international operations are governed by the U.S. Foreign Corrupt Practices Act (FCPA) and other similar anti-corruption laws in other countries. Generally, these laws prohibit companies and their business partners or other intermediaries from making improper payments to foreign governments and government officials in order to obtain or retain business. Global enforcement of such anti-corruption laws has increased in recent years, including aggressive investigations and enforcement proceedings. While we have an active compliance program and various other safeguards to discourage impermissible practices, we have distributors in 90 countries, several of which are considered high risk for corruption. As a result, our global operations carry some risk of unauthorized impermissible activity on the part of one of our distributors, employees, agents or consultants. Any alleged or actual violation could subject us to government scrutiny, severe criminal or civil fines, or sanctions on our ability to export product outside the U.S., which could adversely affect our reputation and financial condition.
Export of U.S. technology or goods manufactured in the United States to some jurisdictions requires special U.S. export authorization or local market controls that may be influenced by factors, including political dynamics, outside our control.
Finally, any other significant changes in the competitive, legal, regulatory, reimbursement or economic environments of the jurisdictions in which we conduct our international business could have a material impact on our business.
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Our future success depends on the continued services of skilled personnel.
We constantly monitor the dynamics of the economy, the healthcare industry and the markets in which we compete; and we continue to assess our key personnel that we believe are essential to our long-term success. Over the last year, we have transitioned to a new Chief Executive Officer, are in the process of hiring a new Chief Financial Officer and have hired new personnel in a number of key executive positions. We have also effected significant organizational and strategic changes in connection therewith. If we fail to effectively manage our ongoing organizational and strategic changes, including the timely identification of a new Chief Financial Officer, our financial condition, results of operations, and reputation, as well as our ability to successfully attract, motivate and retain key employees, could be harmed.
Our success also depends upon our ability to attract and retain other qualified managerial and technical personnel. Competition for such personnel is intense. We may not be able to attract and retain personnel necessary for the development of our business.
If we are unable to meet our debt obligations or experience a disruption in our cash flows, it could have an adverse effect on our financial condition, results of operations, ability to complete our share repurchase program or cost of borrowing.
We have $408.1 million of debt outstanding at April 2, 2016. The obligations to pay interest and repay the borrowed amounts may restrict our ability to adjust to adverse economic conditions, our ability to fund working capital, capital expenditures, acquisition or other general corporate requirements. The interest rate on the loan is variable and subject to change based on market forces. Fluctuations in interest rates could adversely affect our profitability and cash flows.
In addition, as a global corporation we have significant cash reserves held in foreign countries. These balances may not be immediately available to repay our debt.
Our credit facilities contain financial covenants that require us to maintain specified financial ratios and make interest and principal payments. If we are unable to satisfy these covenants, we may be required to obtain waivers from our lenders and no assurance can be made that our lenders would grant such waivers on favorable terms, or at all, and we could be required to repay any borrowed amounts on short notice.
Additional capital that we may require in the future may not be available to us, or only available to us on unfavorable terms.
Our future capital requirements will depend on many factors, including operating requirements, current and future acquisitions and the need to refinance existing debt. Our ability to issue additional debt or enter into other financing arrangements on acceptable terms could be adversely affected by our debt levels, unfavorable changes in economic conditions generally or uncertainties that affect the capital markets. Higher borrowing costs or the inability to access capital markets could adversely affect our ability to support future growth and operating requirements and, as a result, our business, financial condition and results of operations could be adversely affected. As of April 2, 2016, we had $408.1 million of debt obligations due prior to July 1, 2019. Refer to Liquidity and Capital Resources within our Management's Discussion and Analysis of Financial Condition and Results of Operations contained in Item 7 of this Annual Report on Form 10-K for further discussion on debt obligations.
We recorded goodwill and other asset impairment charges during the current fiscal year and may record additional charges in future periods.
We evaluate goodwill for impairment at least annually, or on an interim basis between annual tests when events or circumstances indicate that it is more likely than not that the fair value of a reporting unit is less than its carrying value. During the third quarter of fiscal 2016, we concluded that indicators of potential goodwill impairment were present for the EMEA and Americas Blood Center and Hospital reporting units, therefore requiring an interim test for goodwill impairment. We recorded a preliminary impairment charge of $66.3 million in the EMEA reporting unit during the third quarter of fiscal 2016. During the fourth quarter of fiscal 2016, we completed our goodwill impairment test and concluded that no adjustment to the $66.3 million impairment loss initially recorded was required. The impairment charge recorded in the third quarter of fiscal 2016 represented the entire goodwill balance allocated to EMEA. This charge does not impact our liquidity, cash flows from operations, future operations, or compliance with debt covenants. Although the analysis indicated only the EMEA reporting unit was impaired, we will continue to monitor the Americas Blood Center and Hospital, which has an excess fair value over carrying value of approximately 25.8% and has allocated goodwill of $175.9 million, as this operating unit is most at risk in future periods if our estimated future cash flows differ from our actual operating results.
Additionally, during the third quarter of fiscal 2016 we recorded an impairment charge of $18.7 million to write down the carrying value of the SOLX intangible assets after we updated our assessment of the market potential for the SOLX technology and concluded that it was no longer commercially reasonable to bring this technology to market.
Finally, during the fourth quarter of fiscal 2016, we completed our global strategic review which resulted in the identification of certain long-lived assets, including property, plant and equipment and intangible assets that were at risk of being impaired due
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to changes in the strategic direction of the Company. During the fourth quarter of fiscal 2016, we performed impairment tests for each of the identified assets and based on revised expectations, we recorded asset impairment charges of $16.2 million.
Goodwill impairment charges or other asset impairment charges could materially adversely impact our results of operations in the period in which they are recorded. We will continue to monitor our intangible assets for potential impairments in future periods. Refer to Critical Accounting Policies within our Management's Discussion and Analysis of Financial Condition and Results of Operations contained in Item 7 of this Annual Report on Form 10-K for a discussion of key assumptions used in our testing.
As a medical device manufacturer we are subject to a number of laws and regulations. Non-compliance with those laws or regulations could adversely affect our financial condition and results of operations.
The manufacture, distribution and marketing of our products are subject to regulation by the FDA and other non-United States regulatory bodies. We must obtain specific regulatory clearance prior to selling any new product or service, a process which is costly and time consuming. If we are unable to obtain the necessary regulatory clearance we will be unable to introduce new enhanced product. Our operations are also subject to continuous review and monitoring by the FDA and other regulatory authorities. Failure to substantially comply with applicable regulations could subject our products to recall or seizure by government authorities, or an order to suspend manufacturing activities. If our products were determined to have design or manufacturing flaws, this could result in their recall or seizure. Either of these situations could also result in the imposition of fines.
Many of our competitors have significantly greater financial means and resources, which may allow them to more rapidly develop new technologies and more quickly address changes in customer requirements.
Our ability to remain competitive depends on a combination of factors. Certain factors are within our control such as reputation, regulatory approvals, patents, unpatented proprietary know-how in several technological areas, product quality, safety, cost effectiveness and continued rigorous documentation of clinical performance. Other factors are outside of our control such as regulatory standards, medical standards, reimbursement policies and practices, and the practice of medicine.
Loss of a significant customer could adversely affect our business.
In fiscal 2016, although no one customer represented more than 10% of our revenues, our ten largest customers accounted for 36.0% of our revenue. If any of our largest customers materially reduce their purchases from us or terminate their relationship with us for any reason, we could experience an adverse effect on our results of operations or financial condition.
We may not continue to realize the benefits from our Value Creation and Capture initiatives.
In fiscal 2016, we completed our multi-year Value Creation and Capture initiatives. These initiatives have reduced manufacturing costs and improved supply chain efficiency. However, there are no assurances the cost savings or supply chain efficiencies will continue as our business evolves. In addition, the activities involved the relocation of several product lines to new manufacturing facilities. As these transitions are completed, we may yet experience challenges with the new manufacturing locations, additional costs, or unacceptable quality. These may lead to additional working capital, warranty or inventory costs.
An interruption in our ability to manufacture our products or an inability to obtain key components or raw materials may adversely affect our business.
Certain key products are manufactured at single locations, with limited alternate facilities. If an event occurs that results in damage to one or more of our facilities, we may be unable to manufacture the relevant products at previous levels or at all. In addition, for reasons of quality assurance or cost effectiveness, we purchase certain finished goods, components and raw materials from sole suppliers, notably JMS Co. Ltd., Kawasumi Laboratories and Sanmina Corporation. Due to the stringent regulations and requirements of the FDA and other similar non-U.S. regulatory agencies regarding the manufacture of our products, we may not be able to quickly establish additional or replacement sources for certain components or materials. 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, results of operations, financial condition and cash flows.
Current or worsening economic conditions may adversely affect our business and financial condition.
A portion of our trade accounts receivable outside the United States include sales to government-owned or supported healthcare systems in several countries, which are subject to payment delays. Payment is dependent upon the financial stability and creditworthiness of those countries’ national economies. Worsening economic conditions may lead to the rationing of care or reduced order patterns. Although, we have not incurred significant losses on government receivables to date, we continually evaluate all government receivables for potential collection risks associated with the availability of government funding and reimbursement practices. If the financial condition of customers or the countries’ healthcare systems deteriorate such that their ability to make payments is uncertain, allowances may be required in future periods.
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As a global corporation, we are exposed to fluctuations in currency exchange rates, which could adversely affect our cash flows and results of operations.
International revenues and expenses account for a substantial portion of our operations and we intend to continue expanding our presence in international markets. In fiscal 2016, our international revenues accounted for 42.9% of our total revenues. The exposure to fluctuations in currency exchange rates takes different forms. Reported revenues, as well as manufacturing and operational costs denominated in foreign currencies by our international businesses, fluctuate due to exchange rate movement when translated into U.S. dollars for financial reporting purposes. Fluctuations in exchange rates could adversely affect our profitability in U.S. dollars of products and services sold by us into international markets, where payment for our products and services and related manufacturing and operational costs is made in local currencies.
We are entrusted with sensitive personal information relating to surgical patients, blood donors, employees and other persons in the course of operating our business and serving our customers.
Government agencies require that we implement measures to ensure the integrity and security of such personal data and, in the event of a breach of protocol, we inform affected individuals. If our systems are not properly designed or implemented, or should suffer a breach of security or an intrusion (e.g., “hacking”) by unauthorized persons, the Company’s reputation could be harmed, and it could incur costs and liabilities to affected persons and enforcement agencies.
We rely on the proper function, availability and security of information technology systems to operate our business and to serve our customers and a cyber-attack or other breach of these systems could have a material adverse effect on our business, financial condition or results of operations.
We rely on information technology systems to process, transmit, and store electronic information in our day-to-day operations. Similar to other large multi-national companies, the size and complexity of our information technology systems makes them vulnerable to a cyber-attack, malicious intrusion, breakdown, destruction, loss of data privacy, or other significant disruption. Our information systems require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving systems and regulatory standards, the increasing need to protect patient and customer information, and changing customer patterns. In addition, third parties may attempt to hack into our products to obtain data relating to patients with our products or our proprietary information. Any failure by us to maintain or protect our information technology systems and data integrity, including from cyber-attacks, intrusions or other breaches, could result in the unauthorized access to patient data and personally identifiable information, theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our operations. Any of these events, in turn, may cause us to lose existing customers, have difficulty preventing, detecting, and controlling fraud, have disputes with customers, physicians, and other health care professionals, be subject to legal claims and liability, have regulatory sanctions or penalties imposed, have increases in operating expenses, incur expenses or lose revenues as a result of a data privacy breach or theft of intellectual property, or suffer other adverse consequences, any of which could have a material adverse effect on our business, financial condition or results of operations.
We are subject to the risks associated with communicable diseases. A significant outbreak of a disease could reduce the demand for our products and affect our ability to provide our customers with products and services.
An eligible donor’s willingness to donate is affected by concerns about their personal health and safety. Concerns about communicable diseases (such as pandemic flu, SARS, or HIV) could reduce the number of donors, and accordingly reduce the demand for our products for a period of time. A significant outbreak of a disease could also affect our employees’ ability to work, which could limit our ability to produce product and service our customers.
There is a risk that the Company’s intellectual property may be subject to misappropriation in some countries.
Certain countries, particularly China, do not enforce compliance with laws that protect intellectual property (“IP”) rights with the same degree of vigor as is available under the U.S. and European systems of justice. Further, certain of the Company’s IP rights are not registered in China, or if they were, have since expired. This may permit others to produce copies of products in China that are not covered by currently valid patent registrations. There is also a risk that such products may be exported from China to other countries.
In order to aggressively protect our IP throughout the world, we have a program of patent disclosures and filings in markets where we conduct significant business. While we believe this program is reasonable and adequate, the risk of loss is inherent in litigation as different legal systems offer different levels of protection to IP, and it is still possible that even patented technologies may not be protected absolutely from infringement.
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Pending and future intellectual property litigation could be costly and disruptive to us.
We operate in an industry that is susceptible to significant intellectual property litigation. This type of litigation is expensive, complex and lengthy and its outcome is difficult to predict. Patent litigation may result in adverse outcomes and could significantly divert the attention of our technical and management personnel.
The technologies that support our products are the subject of active patent prosecution.
There is a risk that one or more of our products may be determined to infringe a patent held by another party. If this were to occur we may be subject to an injunction or to payment of royalties, or both, which may adversely affect our ability to market the affected product(s). In addition, competitors may patent technological advances which may give them a competitive advantage or create barriers to entry.
We sell our products in certain emerging economies.
There are risks with doing business in emerging economies, such as Brazil, Russia, India and China. These economies tend to have less mature product regulatory systems, and more volatile financial markets. In addition, the government controlled health care system's ability to invest in our products and systems may abruptly shift due to changing government priorities or funding capacity. Our ability to sell products in these economies is dependent upon our ability to hire qualified employees or agents to represent our products locally, and our ability to obtain and maintain the necessary regulatory approvals in a less mature regulatory environment. If we are unable to retain qualified representatives or maintain the necessary regulatory approvals, we will not be able to continue to sell products in these markets. We are exposed to a higher degree of financial risk if we extend credit to customers in these economies.
In many of the international markets in which we do business, including certain parts of Europe, South America, the Middle East, Russia and Asia, our employees, agents or distributors offer to sell our products in response to public tenders issued by various governmental agencies.
There is additional risk in selling our products through agents or distributors, particularly in public tenders. If they misrepresent our products, do not provide appropriate service and delivery, or commit a violation of local or U.S. law, our reputation could be harmed, and we could be subject to fines, sanctions or both.
We have a complex global supply chain which includes key sole source suppliers.
We have a complex global supply chain which involves integrating key suppliers and our manufacturing capacity into a global movement of components and finished goods.
We have certain key suppliers, including JMS Co. Ltd. ("JMS"), Kawasumi Laboratories ("Kawasumi") and Sanmina Corporation, who have their own complex supply chains. JMS and Kawasumi make certain finished goods and important sub components in locations throughout Asia. We have engaged Sanmina Corporation to be the sole manufacturer of certain equipment as part of our manufacturing network optimization activities.
Any disruption to one or more of our suppliers’ production or delivery of sufficient volumes of subcomponents conforming to our specifications could disrupt or delay our ability to deliver finished products to our customers. For example, we purchase components in Asia for use in manufacturing in the United States, Puerto Rico, Mexico and Scotland. We also regularly ship finished goods from the United States, Puerto Rico, Mexico and Scotland to Europe and Asia.
Plastics are the principal component of our disposables, which are the main source of our revenues. Any change in the price, composition or availability of the plastics we purchase could adversely affect our business.
We have three risks with this key raw material: price, composition and availability.
Increases in the price of petroleum derivatives could result in corresponding increases in our costs to procure plastic raw materials. Increases in the costs of other commodities may affect our procurement costs to a lesser degree.
The composition of the plastic we purchase is also important. Today, we purchase plastics which contain phthalates, which are used to make plastic malleable. Should plastics with phthalates become unavailable due to regulatory changes, we may be required to obtain new FDA or foreign approvals for a number of products.
While we have not experienced shortages in the past, any interruption in the supply for certain plastics could have a material impact on our business by limiting our ability to manufacture and sell the products which represent a significant portion of our revenues.
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Our products are made with materials which are subject to regulation by governmental agencies.
Environmental regulations may prohibit the use of certain compounds in products we market and sell in regulated markets. If we are unable to substitute suitable materials into our processes, our manufacturing operations may be disrupted. In addition, we may be obligated to disclose the origin of certain materials used in our products, including but not limited to, metals mined from locations which have been the site of human rights violations.
We operate in an industry susceptible to significant product liability claims.
Our products are relied upon by medical personnel in connection with the treatment of patients and the collection of blood from donors. In the event that patients or donors sustain injury or death in connection with their condition or treatment, we, along with others, may be sued, and whether or not we are ultimately determined to be liable, we may incur significant legal expenses. These claims may be brought by individuals seeking relief on their own behalf or purporting to represent a class. In addition, product liability claims may be asserted against us in the future based on events we are not aware of at the present time.
In addition, such litigation could damage our reputation and, therefore, impair our ability to market our products, obtain professional or product liability insurance, or increase the cost of such insurance. While we believe that our current product liability insurance coverage is sufficient, there is no assurance that such coverage will be adequate to cover incurred liabilities or that we will be able to obtain acceptable product and professional liability coverage in the future.
We have disclosed a material weakness in our internal controls over financial reporting relating to our accounting for income taxes, which could adversely affect our ability to report our financial condition, results of operations or cash flows accurately and on a timely basis.
In connection with our assessment of internal controls over financial reporting under Section 404 of the Sarbanes-Oxley Act of 2002, we identified a material weakness in our internal controls over financial reporting relating to our accounting for income taxes. For a discussion of our internal controls over financial reporting and a description of the identified material weakness, see "Controls and Procedures" in Part II, Item 9A of this Report.
A material weakness is a deficiency, or a combination of deficiencies, in internal controls over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Management's assessment identified control deficiencies associated with the transition from utilizing tax consultants to establishing expanded in-house tax capabilities and resources, as well as issues in the design and implementation of controls to review and analyze the Company's income tax provisions, income taxes payable and receivable, and deferred income tax balances that led management to conclude that control deficiencies existed at April 2, 2016. While reported tax provisions and related accounts are believed to be accurate, as a result of these deficiencies, until they are substantially remediated, it is possible that internal controls over financial reporting may not prevent or detect errors in the tax accounting reflected in our financial statements from occurring that could be material, either individually or in the aggregate.
While actions have been taken to improve our internal controls in response to the identified material weakness related to certain aspects of accounting for income taxes, additional work continues to address and remediate the identified material weakness. Until these actions are fully implemented and tested, a material weakness in our internal controls over financial reporting relating to income taxes will continue to exist. As a result, our ability to accurately report, on a timely basis, our future financial condition, results of operations or cash flows may be adversely affected.
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ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
Our owned headquarters facility is located in Braintree, Massachusetts and consists of two buildings which are approximately 180,000 and 44,000 square feet. As of April 2, 2016, we owned or leased a total of 68 facilities. Our owned and leased facilities consist of approximately 1.8 million square feet. Included within these properties are 8 manufacturing facilities. We believe all of these facilities are well-maintained and suitable for the operation conducted in them. We consider the following manufacturing facilities to be material to the business.
Leetsdale, Pennsylvania is an approximately 82,000 square foot leased facility which is used for warehousing, distribution and manufacturing operations primarily supporting our plasma business. Annual lease expense is approximately $0.4 million for this facility.
Draper, Utah is an approximately 100,000 square foot owned facility used for distribution and manufacturing operations supporting our plasma business. During fiscal 2015, the Company purchased this facility for $6.6 million.
The Company leases a facility in Fajardo, Puerto Rico that is approximately 115,000 square feet under an agreement with Pall Corporation executed in connection with the Company's acquisition of Pall's transfusion medicine business on August 1, 2012. This facility is used for production of blood filters.
The Company owns a facility in Bothwell, Scotland used to manufacture disposable products for our European and Asian customers. This facility is approximately 40,000 square feet.
The Company leases 127,000 square feet of space in Tijuana, Mexico with an Annual lease expense of approximately $0.7 million. The Company also owns a facility in Tijuana, Mexico that is approximately 182,000 square feet. These facilities are used for the production of whole blood collection kits, blood center and hospital disposables, and intra-plant components.
The Company owns approximately 240,000 square feet of space in Penang, Malaysia used to manufacture disposable products for our European and Asian customers. The Company leases the land on which the facility was built and the lease payments have been prepaid. The lease term of 30 years expires in 2043 with an option to renew for a period of no less than 10 years.
The Company's facilities are used by the following business segments:
Number of Facilities | ||
Japan | 12 | |
EMEA | 16 | |
North America Plasma | 3 | |
All Other | 37 | |
Total | 68 | |
ITEM 3. LEGAL PROCEEDINGS
We are presently engaged in various legal actions, and although our ultimate liability cannot be determined at the present time, we believe, based on consultation with counsel, that any such liability will not materially affect our consolidated financial position or our results of operations.
Italian Employment Litigation
Our Italian manufacturing subsidiary is party to several actions initiated by employees of the facility in Ascoli-Piceno, Italy where we have ceased manufacturing operations. These include actions claiming (i) working conditions and minimum salaries should have been established by either a different classification under their national collective bargaining agreement or a different agreement altogether, (ii) certain solidarity agreements, which are arrangements between the Company, employees and the government to continue full pay and benefits for employees who would otherwise be terminated in times of low demand, are void, and (iii) payment of the extra time used for changing into and out of the working clothes at the beginning and end of each shift.
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In addition, a union represented in the Ascoli plant has filed an action claiming that the Company discriminated against it in favor of three other represented unions by (i) interfering with an employee referendum, (ii) interfering with an employee petition to recall union representatives from office, and (iii) excluding the union from certain meetings.
Finally, we have been added as defendants on claims filed against Pall Corporation prior to our acquisition of the plant in August 2012. These claims relate to agreements to "freeze" benefit allowances for a certain period in exchange for Pall's commitments on hiring and plant investment.
As of April 2, 2016, the total amount of damages claimed by the plaintiffs in these matters is approximately $4.6 million; however, it is not possible at this point in the proceedings to accurately evaluate the likelihood or amount of any potential losses. We may receive other similar claims in the future.
ITEM 4. MINE SAFETY DISCLOSURES
None.
ITEM 4A. EXECUTIVE OFFICERS
Executive Officers of the Registrant
The information concerning our Executive Officers is as follows. Executive officers are elected by and serve at the discretion of our Board of Directors. There are no family relationships between any director or executive officer and any other director or executive officer of Haemonetics Corporation.
RONALD GELBMAN (age 68) Interim Chief Executive Officer September 2015 to May 2016, has been a member of the Haemonetics Board of Directors since 2000 and, until his appointment as Interim CEO in September of 2015, was Chair of the Governance and Compliance Committee and a member of the Audit Committee. Mr. Gelbman is a former member of the Executive Committee of Johnson & Johnson, and served as Worldwide Chairman of the Pharmaceuticals and Diagnostics Group.
CHRISTOPHER SIMON (age 52) President and Chief Executive Officer joined Haemonetics in May, 2016. Mr. Simon previously served as a Senior Partner of McKinsey & Company in Global Medical Products Practice. Mr. Simon was a consultant with McKinsey & Company since 1993 and recently was the Lead Partner for McKinsey & Company’s current strategy review with Haemonetics. Prior to that, he served in commercial roles with Baxter Healthcare Corporation.
CHRISTOPHER LINDOP (age 58) Executive Vice President, Business Development and Chief Financial Officer joined Haemonetics in January of 2007 as Chief Financial Officer and has announced his retirement from Haemonetics effective June 3, 2016. In 2007, Mr. Lindop assumed responsibility for business development. Prior to joining Haemonetics, he was Chief Financial Officer at Inverness Medical Innovations, a rapidly growing global developer of advanced consumer and professional diagnostic products from 2003 to 2006. Prior to this, Mr. Lindop was a Partner in the Boston offices of Ernst & Young LLP and Arthur Andersen LLP.
KENT DAVIES (age 53) Chief Operating Officer joined Haemonetics as President, Global Markets in April 2014. In April 2015, he was promoted to Chief Operating Officer. In this role, he is responsible for worldwide oversight of all of Haemonetics’ commercial operations, including product development and product management. Previously, Mr. Davies was the Chief Executive Officer of RoundTable Healthcare Partners' RoundTable III Platform Development Corporation ("RPDC") where he focused on the identification and development of new investment opportunities in the medical device market.
DAVID FUSCO (age 42) Executive Vice President, Global Human Resources joined Haemonetics in July, 2015. Mr. Fusco is responsible for Haemonetics' global human capital programs including talent management, organization development, total rewards and the human resources business partner support program aimed at advancing our employee engagement and culture. Previously, Mr. Fusco was the Vice President of Human Resources of Parexel International where he was responsible for the Global Human Resources business partner management and the enterprise wide human capital programs.
SANDRA JESSE (age 63) Executive Vice President, Chief Legal Officer joined Haemonetics as Vice President, Chief Legal Officer in September 2011, and is responsible for the company’s Legal, Compliance and Corporate Audit and Controls groups. Ms. Jesse was previously the Executive Vice President and Chief Legal Officer of Blue Cross Blue Shield of Massachusetts, a Partner in the Boston law firm of Choate, Hall and Stewart, and Press Secretary for a United States Congressman, Lee Hamilton.
NEIL RYDING (age 55) Executive Vice President, Global Operations joined Haemonetics in September, 2015. Prior to joining Haemonetics, Mr. Ryding had over 30 years of experience in leading global manufacturing operations and supply chain
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organizations in regulated environments within the aerospace and medical device industries. Mr. Ryding’s previous experience includes various roles with Rolls Royce Aero-Engines, Johnson & Johnson, Smith & Nephew, Cardinal Health and Hospira.
BYRON SELMAN (age 49) President, Global Markets joined Haemonetics in 2012 as President, North America. In January of 2015, Mr. Selman was promoted to President, Americas. Mr. Selman was then promoted to President, Global Markets in April 2015. Mr. Selman was previously with Pall Corporation for 21 years where he most recently served as President of Global Medical.
DAN GOLDSTEIN (age 39) Vice President and Corporate Controller, joined Haemonetics in 2016. In April of 2016, Mr. Goldstein was appointed principal accounting officer. Prior to joining the Company, Mr. Goldstein was Vice President Technical Accounting and Advisory Services for Covidien PLC, a global health care products company. At Covidien, Mr. Goldstein had previously held the roles of Business Unit Controller, Sustainable Technologies and Director, Corporate Reporting. Prior to Covidien, Mr. Goldstein held positions at EMC Corporation and Calpine Corporation.
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PART II
ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our common stock is listed on the New York Stock Exchange under the symbol HAE. The following table sets forth for the periods indicated the high and low sales prices of such common stock, which represent actual transactions as reported by the New York Stock Exchange.
First Quarter | Second Quarter | Third Quarter | Fourth Quarter | ||||||||||||
Fiscal year ended April 2, 2016: | |||||||||||||||
Market price of Common Stock: | |||||||||||||||
High | $ | 45.32 | $ | 42.24 | $ | 34.63 | $ | 35.67 | |||||||
Low | $ | 39.69 | $ | 34.13 | $ | 29.70 | $ | 29.20 | |||||||
Fiscal year ended March 28, 2015: | |||||||||||||||
Market price of Common Stock: | |||||||||||||||
High | $ | 35.73 | $ | 37.13 | $ | 39.07 | $ | 45.43 | |||||||
Low | $ | 29.86 | $ | 33.92 | $ | 33.75 | $ | 36.48 | |||||||
Holders
There were approximately 181 holders of record of the Company’s common stock as of April 2, 2016.
Dividends
The Company has never paid cash dividends on shares of its common stock and does not expect to pay cash dividends in the foreseeable future.
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Stock Performance
The following graph compares the cumulative 5-year total return provided to shareholders on Haemonetics Corporation’s common stock relative to the cumulative total returns of the S&P 500 index and the S&P Health Care Equipment index. An investment of $100 (with reinvestment of all dividends) is assumed to have been made in our common stock and in each of the indexes on 4/2/2011 and its relative performance is tracked through 4/2/2016.
___________________________________
* | $100 invested on 4/2/2011 in stock or index, including reinvestment of dividends. Fiscal year ended April 2, 2016. | |
4/11 | 3/12 | 3/13 | 3/14 | 3/15 | 4/16 | |||||||||||||
Haemonetics Corporation | 100.00 | 104.69 | 125.18 | 96.48 | 132.84 | 106.04 | ||||||||||||
S&P 500 | 100.00 | 105.71 | 117.77 | 139.42 | 154.68 | 155.57 | ||||||||||||
S&P Health Care Equipment | 100.00 | 106.08 | 119.18 | 148.88 | 184.83 | 178.92 | ||||||||||||
Note: The stock price performance included in this graph is not necessarily indicative of future stock price performance. This graph shall not be deemed "filed" for purposes of Section18 of the Exchange Act or otherwise subject to the liabilities of that section nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing.
Unregistered Sales of Equity Securities and Use of Proceeds
None.
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Issuer Purchases of Equity Securities
On April 28, 2014, the Company announced that its Board of Directors approved the repurchase of up to $100.0 million of Company shares, subject to compliance with its loan covenants. We completed this repurchase program during the second quarter of fiscal 2016. In total, we repurchased approximately 2.7 million shares at a total cost of $100.0 million under this plan. We reflect stock repurchases in our financial statements on a “trade date” basis and as Authorized Unissued (Haemonetics is a Massachusetts company and under Massachusetts law repurchased shares are treated as authorized but unissued). All of the purchases were made under the publicly announced program and were made in the open market.
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ITEM 6. SELECTED FINANCIAL DATA
Haemonetics Corporation Five-Year Review
(In thousands, except per share and employee data) | 2016 | 2015 | 2014 | 2013 | 2012 | ||||||||||||||
Summary of Operations | |||||||||||||||||||
Net revenues | $ | 908,832 | $ | 910,373 | $ | 938,509 | $ | 891,990 | $ | 727,844 | |||||||||
Cost of goods sold | 502,918 | 475,955 | 470,144 | 463,859 | 358,604 | ||||||||||||||
Gross profit | 405,914 | 434,418 | 468,365 | 428,131 | 369,240 | ||||||||||||||
Operating expenses: | |||||||||||||||||||
Research and development | 44,965 | 54,187 | 54,200 | 44,394 | 36,801 | ||||||||||||||
Selling, general and administrative | 317,223 | 337,168 | 365,977 | 323,053 | 245,835 | ||||||||||||||
Impairment of assets | 92,395 | 5,441 | 1,711 | 4,247 | — | ||||||||||||||
Contingent consideration (income) expense | (4,727 | ) | (2,918 | ) | 45 | — | (2,154 | ) | |||||||||||
Total operating expenses | 449,856 | 393,878 | 421,933 | 371,694 | 280,482 | ||||||||||||||
Operating (loss) income | (43,942 | ) | 40,540 | 46,432 | 56,437 | 88,758 | |||||||||||||
Other (expense) income, net | (9,474 | ) | (9,375 | ) | (10,031 | ) | (6,540 | ) | 740 | ||||||||||
(Loss) income before provision for income taxes | (53,416 | ) | 31,165 | 36,401 | 49,897 | 89,498 | |||||||||||||
Provision for income taxes | 2,163 | 14,268 | 1,253 | 11,097 | 22,612 | ||||||||||||||
Net (loss) income | $ | (55,579 | ) | $ | 16,897 | $ | 35,148 | $ | 38,800 | $ | 66,886 | ||||||||
(Loss) income per share: | |||||||||||||||||||
Basic | $ | (1.09 | ) | $ | 0.33 | $ | 0.68 | $ | 0.76 | $ | 1.32 | ||||||||
Diluted | $ | (1.09 | ) | $ | 0.32 | $ | 0.67 | $ | 0.74 | $ | 1.30 | ||||||||
Weighted average number of shares | 50,910 | 51,533 | 51,611 | 51,349 | 50,727 | ||||||||||||||
Common stock equivalents | — | 556 | 766 | 910 | 863 | ||||||||||||||
Weighted average number of common and common equivalent shares | 50,910 | 52,089 | 52,377 | 52,259 | 51,590 | ||||||||||||||
2016 | 2015 | 2014 | 2013 | 2012 | |||||||||||||||
Financial and Statistical Data: | |||||||||||||||||||
Working capital | $ | 302,535 | $ | 368,985 | $ | 391,944 | $ | 403,153 | $ | 386,784 | |||||||||
Current ratio | 2.6 | 3.0 | 2.8 | 3.2 | 4.0 | ||||||||||||||
Property, plant and equipment, net | $ | 337,634 | $ | 321,948 | $ | 271,437 | $ | 256,953 | $ | 161,657 | |||||||||
Capital expenditures | $ | 102,405 | $ | 122,220 | $ | 73,648 | $ | 62,188 | $ | 53,198 | |||||||||
Depreciation and amortization | $ | 89,911 | $ | 86,053 | $ | 81,740 | $ | 65,481 | $ | 49,966 | |||||||||
Total assets | $ | 1,319,128 | $ | 1,485,417 | $ | 1,514,178 | $ | 1,461,917 | $ | 911,135 | |||||||||
Total debt | $ | 408,000 | $ | 427,891 | $ | 437,687 | $ | 480,094 | $ | 3,771 | |||||||||
Stockholders’ equity | $ | 721,565 | $ | 826,122 | $ | 837,888 | $ | 769,182 | $ | 732,631 | |||||||||
Debt as a % of stockholders’ equity | 56.5 | % | 51.8 | % | 52.2 | % | 62.4 | % | 0.5 | % | |||||||||
Employees | 3,225 | 3,383 | 3,782 | 3,563 | 2,337 | ||||||||||||||
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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Our Business
Haemonetics is a global healthcare company dedicated to providing innovative products to customers involved in the processing, handling and analysis of blood. We offer a comprehensive portfolio of integrated devices, information management, and consulting services with the goal of helping improve clinical outcomes and reduce costs for blood and plasma collectors, hospitals, and patients around the world.
Blood and its components (plasma, platelets, and red cells) have many vital and frequently life-saving clinical applications. Plasma is used for patients with major blood loss and is manufactured into pharmaceuticals to treat a variety of illnesses and hereditary disorders such as hemophilia. Red cells treat trauma patients or patients undergoing surgery with high blood loss, such as open heart surgery or organ transplant. Platelets treat cancer patients undergoing chemotherapy. Blood is essential to a modern healthcare system.
Recent Developments
Global Strategic Review
We recently undertook a global strategic review of our business portfolio to identify which end markets and product franchises have the strongest growth opportunities. As a result of that review, we organized our current products into four franchises for purposes of evaluating their growth potential: Plasma, Hemostasis Management, Donor and Cell Processing. In that review, “Plasma” included plasma collection devices and disposables, plasma donor management software and anticoagulant and saline sold to plasma customers. “Hemostasis Management” included devices and methodologies for measuring coagulation characteristics of blood, such as our TEG® Hemostasis Analyzer. “Donor” included blood collection and processing devices and disposables for red cells, platelets and whole blood as well as related donor management software. “Cell Processing” included surgical blood salvage systems, specialized blood cell processing systems, disposables and blood transfusion management software.
In connection with this strategic review, we concluded that Plasma and Hemostasis Management have the greatest growth potential, while Cell Processing innovation offers an opportunity to increase market share and expand into new segments. Donor is competing in challenging markets which require us to manage the business differently, including reducing costs and the scope of the current product line. In recognition of these conclusions, we have begun to implement an operating model that will streamline the management structure and rationalize our cost structure, with an aim to bring about sustainable productivity improvement across the organization. Overall, we expect implementation of our new direction will require multiple changes and will extend beyond fiscal 2017.
Restructuring Initiative
During the first quarter of fiscal 2017, in connection with our global strategic review, we launched the first phase of a restructuring program designed to reposition our organization and improve our cost structure. The first phase includes both a reduction of headcount and operating costs as well as projects to simplify product lines. We may also take additional steps to modify our manufacturing operations to reflect our strategic direction.
We expect to incur approximately $26 million of restructuring and transformation charges, comprised of $17 million in termination benefits and $9 million in other related exit costs. Substantially all of these charges will result in future cash outlays and are expected to be incurred during fiscal 2017. Savings from this program are estimated to be approximately $40 million in fiscal 2017. Subsequent phases of the program may require restructuring charges in future fiscal years.
Impairments
◦ | Goodwill. As discussed in Note 5, Goodwill and Intangible Assets, to our consolidated financial statements contained in Item 8 of this Annual Report on Form 10-K, we evaluate goodwill for impairment at least annually, or on an interim basis between annual tests when events or circumstances indicate that it is more likely than not that the fair value of a reporting unit is less than its carrying value. During the third quarter of fiscal 2016, we concluded that indicators of potential goodwill impairment were present for the EMEA and Americas Blood Center and Hospital reporting units, therefore requiring an interim test for goodwill impairment. We recorded a preliminary impairment charge of $66.3 |
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million in the EMEA reporting unit during the third quarter of fiscal 2016. During the fourth quarter of fiscal 2016, we completed our second step of the goodwill impairment test and concluded that no adjustment to the $66.3 million impairment loss initially recorded was required. The impairment charge recorded in the third quarter of fiscal 2016 represented the entire goodwill balance allocated to EMEA.
◦ | SOLX. In April 2013, we acquired a patented red cell storage solution, referred to as SOLX, from Hemerus Medical, LLC for cash consideration of $24.1 million plus an agreement to make certain future payments accounted for as contingent consideration. We acquired SOLX to complement the portfolio of whole blood collection, filtration and processing product lines and to bring greater efficiency and productivity to whole blood collection and processing. During the third quarter of fiscal 2016, we received U.S. Food and Drug Administration clearance for the SOLX solution with a Haemonetics whole blood filter. At that time, the vast majority of the U.S. market utilized a red cell filter, not a whole blood filter, for whole blood collection procedures as they seek to optimize blood component yield from each collection. To bring SOLX to market with a red cell filter would have required substantial additional investment. Accordingly, we conducted a final market review prior to proceeding with this investment, which indicated customers would not pay a price for a SOLX collection kit sufficient to recover the cost to produce it, or to provide an adequate return on the additional investment. As result, in fiscal 2016, we suspended further investment in the SOLX technology and recorded an impairment charge of $18.7 million to write down the carrying value of the SOLX intangible assets. In addition, we reversed the $4.9 million of contingent consideration liability we had recorded, as we now do not expect to achieve the conditions that called for its payment. |
◦ | Other Assets. During the fourth quarter of fiscal 2016, we completed our global strategic review which resulted in the identification of certain long-lived assets, including property, plant and equipment and intangible assets that were at risk of being impaired due to changes in the strategic direction of the Company. During the fourth quarter of fiscal 2016, we performed impairment tests for each of the identified assets and based on revised expectations, we recorded asset impairment charges of $16.2 million. These charges included the write down of $9.1 million of property, plant and equipment and $7.1 million of intangible assets. Refer to Note 5, Goodwill and Intangible Assets, and Note 12, Property, Plant and Equipment, to our consolidated financial statements contained in Item 8 of this Annual Report on Form 10-K for further information. |
Declines in U.S. Blood Center Collections
In fiscal 2016, sales of our whole blood disposables to U.S. blood centers represented less than 6% of our total revenue. The demand for these disposable products in the U.S. declined in fiscal 2015 and 2014 due to a rapid decline in demand for blood products associated with actions taken by hospitals to improve blood management techniques and protocols. During the fiscal 2016, the decline in U.S. blood center collections was approximately 7%, compared to approximately 10% in fiscal 2015.
In response to this trend, certain large U.S. blood center collection groups pursued single source vendors for whole blood collection products which required significant reductions in average selling prices in order to retain or increase our share of their business. During fiscal 2014, we entered into a multi-year agreement to supply the HemeXcel Purchasing Alliance, LLC with certain whole blood collection components during the calendar years 2014-2016. The agreement included a reduction in average selling prices which was implemented at the end of first quarter of fiscal 2015. In March 2014, the American Red Cross selected another exclusive supplier to provide certain whole blood products. This reduced annualized revenues by approximately $25 million beginning in the second quarter of fiscal 2015.
Apheresis Red Cell Collection Arrangements
During the first half of fiscal 2016, the American Red Cross and two group purchasing organizations representing other U.S. blood collectors ("Blood Center GPOs") pursued arrangements for apheresis red cell collections. These negotiations have concluded and will negatively affect red cell revenues and gross margins. The expected negative impact on fiscal 2017 operating income as a result of these negotiations is approximately $12 million. Red cell disposable revenues in the U.S. totaled $34.8 million during fiscal 2016 and $37.6 million during fiscal 2015.
On August 1, 2015, we entered into a contract for apheresis devices and single-use disposables with the American Red Cross which has resulted in a decrease in revenue and gross profit in our Blood Center business. In accordance with this agreement, we provided a one-time payment to assist in the transition of red cell collections to our technology. This contract is expected to result in 100% share of the American Red Cross's apheresis red cell collection business and higher sales volumes, but at lower prices. The impact of the price concessions began in the third quarter of fiscal 2016, while the transition to a higher share of the American Red Cross' business is ongoing.
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In addition, both Blood Center GPOs have recommended competitive technologies to their members. We expect revenue to decline as their individual blood center members convert to the competitive technologies.
Value Creation and Capture Initiatives
In fiscal 2016, we completed our Value Creation and Capture (“VCC”) opportunities initiative. This initiative included (i) discontinuation of manufacturing activities at our Ascoli-Piceno, Italy and Braintree, Massachusetts facilities, (ii) expansion of our current facility in Tijuana, Mexico, (iii) transfer of all equipment production to our contract manufacturer, Sanmina Corporation, and (iv) consolidation of the manufacturing of product formerly produced in the U.S. and Italy to our new manufacturing facility in Penang, Malaysia. We continue to manufacture in Bothwell, Scotland. See the Liquidity and Capital Resources discussion for further discussion of the costs of these activities.
Market Trends
Plasma Market
There are two key aspects to the market for our plasma products; the growth in demand for plasma-derived pharmaceuticals and the limited number of significant bio-pharmaceutical companies in this market.
Changes in demand for plasma-derived pharmaceuticals, particularly immunoglobulin (“IG”), are the key driver of plasma collection volumes in the bio-pharmaceutical market. Various factors related to the supply of plasma and the production of plasma-derived pharmaceuticals also affect collection volume, including the following:
• | Several blood collectors supply additional plasma to fractionators, and thus plasma supply can rise overall but not directly impact our plasma business. |
• | Bio-pharmaceutical companies are seeking more efficient production processes, to meet growing demand for pharmaceuticals without requiring an equivalent increase in plasma supply. |
• | Reimbursement guidelines affect the demand for end product pharmaceuticals, although off-label use of pharmaceuticals is growing, in particular for Alzheimer's treatment. |
• | Newly approved indications for, and the growing understanding and thus diagnosis of auto-immune diseases treated with plasma derived therapies increase the demand for plasma, as do longer lifespans and a growing aging patient population. |
• | Geographical expansion of biopharmaceuticals also increases demand for plasma. |
Despite the overall growth in the market, the number of bio-pharmaceutical companies who fractionate plasma is limited. And while the global trend toward consolidation among these companies has stabilized, we do not expect meaningful new entries or diversification.
Demand for our plasma products in fiscal 2016 continued to grow in North America as collection volumes benefited from an expanding end user market for plasma-derived biopharmaceuticals with U.S. produced plasma meeting an increasing percentage of plasma volume demand worldwide.
Blood Center Market
In the blood center market, we sell products used in the collection of platelets, red cells and whole blood. Whole blood is collected from the donor and then transported to a laboratory where it is separated into its components: red cells, platelets or plasma. While we sell products around the world, a significant portion of our sales are to a limited number of customers due to relatively limited number of blood collectors.
Platelets are collected globally, although each local market can be quite different. Despite modest increases in the demand for platelets in Europe and Japan, improved collection efficiencies that increase the yield of platelets per collection and more efficient use of collected platelets have resulted in a flat market for automated collections and related disposables in these countries. In particular, the use of "double dose" collection methods in Europe and Japan has increased. Double dose collections involve collecting two therapeutic platelet doses from one donor. Competition in double dose collection technology is intense and can negatively impact our sales in markets where these collections are prevalent.
Blood management is an approach to optimizing the care of patients that may need a transfusion that includes a wide range of practices and protocols which influence the need for, and use of, blood products in hospitals. Adoption of blood management
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practices by hospitals, particularly in the United States, continues to gain momentum. Blood management efforts reduce the demand for red cells, which in turn can reduce the demand for our red cell and whole blood collection products.
Balancing these trends in the United States, Europe and Japan is the development of emerging markets. With changes in healthcare and social security systems in emerging markets, a larger number of people are gaining access to state of the art medical treatments, which drives the demand for platelet transfusions, in particular, and represent a growing market.
As discussed in Recent Developments above, we believe the decline in U.S. blood center collections of approximately 7% in fiscal 2016 will continue in fiscal 2017. Demand for red cells has declined in mature markets due to better blood management and the development of less invasive, lower blood loss medical procedures. However, highly populated emerging market countries are increasing their demand for blood components as they are advancing their health care coverage, and as greater numbers of people gain access to more advanced medical treatment, demand for blood components, including red cells increases directly.
Hospital Market
In the hospital market, we sell cardiovascular and orthopedic surgical blood salvage systems, and hemostasis management analyzers.
Our Cell Saver surgical blood salvage system was designed as a solution for rapid, high volume blood loss procedures, such as cardiovascular surgeries. In recent years, more efficient blood use and less invasive cardiovascular surgeries have reduced demand for this device and contributed to intense competition in mature markets, while increased access to healthcare in emerging economies has provided new markets and sources of growth.
Our OrthoPAT technology is used to salvage red cells in high blood loss orthopedic procedures, including hip and knee replacement surgeries. Over the last three years, improved blood management practices, including the use of tranexamic acid to treat and prevent post-operative bleeding, have significantly reduced the use of OrthoPAT.
Our TEG Thrombelastograph Hemostasis Analyzers are diagnostic tools which provides a comprehensive assessment of a patient’s overall hemostasis. This information enables caregivers to decide the best blood-related clinical treatment for the individual patient in order to minimize blood loss. The use of our TEG 5000 analyzer continues to expand beyond cardiac surgery into trauma and other clinical uses. TEG product line sales further strengthened in fiscal 2016, with strong performance in North America and China. This product’s growth is dependent on hospitals adopting this technology in their blood management programs. We have launched our next generation device, the TEG 6s, in certain markets in Europe and Asia. In North America, our largest market for TEG, TEG 6s is in a limited market release.
Software Market
Our software solutions portfolio addresses many of the critical data collection and data management needs within the plasma, blood center, and hospital markets.
In the plasma market, we provide software which assists in collection center management. Our Next Generation Donor Management Software has been favorably received by the market and is being implemented at two significant customers.
In the blood center market for software, we currently participate most actively in the United States, where expansion to new or emerging technology platforms such as our El Dorado Software Solution Suite has been slow due to industry consolidation and the relatively high cost of migrating to new information technology platforms. This trend has limited revenue growth and will likely continue to minimize potential opportunities in the future. However, in the immediate future high switching costs and recurring maintenance revenue streams from existing customers has provided relative revenue stability in this product group.
We currently participate in the hospital software market primarily in the United States and Europe. In the United States, we have experienced growth in our installed base for our hospital transfusion solution, SafeTraceTX, due to demand for reliable, proven safety systems within transfusion services. However, growth in the United States continues to be constrained due to hospital IT organization focus on the electronic medical records mandates. Revenues from BloodTrack, a blood inventory and transfusion management system, have increased in the United States and Europe recently as hospitals seek means to improve efficiencies and meet compliance guidelines for tracking and dispositioning blood components to patients.
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Financial Summary
(In thousands, except per share data) | April 2, 2016 | March 28, 2015 | March 29, 2014 | % Increase/(Decrease) 16 vs. 15 | % Increase/(Decrease) 15 vs. 14 | ||||||||||||
Net revenues | $ | 908,832 | $ | 910,373 | $ | 938,509 | (0.2 | )% | (3.0 | )% | |||||||
Gross profit | $ | 405,914 | $ | 434,418 | $ | 468,365 | (6.6 | )% | (7.2 | )% | |||||||
% of net revenues | 44.7 | % | 47.7 | % | 49.9 | % | |||||||||||
Operating expenses | $ | 449,856 | $ | 393,878 | $ | 421,933 | 14.2 | % | (6.6 | )% | |||||||
Operating (loss) income | $ | (43,942 | ) | $ | 40,540 | $ | 46,432 | n/m | (12.7 | )% | |||||||
% of net revenues | (4.8 | )% | 4.5 | % | 4.9 | % | |||||||||||
Other expense, net | $ | (9,474 | ) | $ | (9,375 | ) | $ | (10,031 | ) | 1.1 | % | (6.5 | )% | ||||
(Loss) income before taxes | $ | (53,416 | ) | $ | 31,165 | $ | 36,401 | n/m | (14.4 | )% | |||||||
Provision for income tax | $ | 2,163 | $ | 14,268 | $ | 1,253 | (84.8 | )% | n/m | ||||||||
% of pre-tax income | (4.0 | )% | 45.8 | % | 3.4 | % | |||||||||||
Net (loss) income | $ | (55,579 | ) | $ | 16,897 | $ | 35,148 | n/m | (51.9 | )% | |||||||
% of net revenues | (6.1 | )% | 1.9 | % | 3.7 | % | |||||||||||
Net (loss) income per share - diluted | $ | (1.09 | ) | $ | 0.32 | $ | 0.67 | n/m | (52.2 | )% | |||||||
Our fiscal year ends on the Saturday closest to the last day of March. Fiscal year 2016 includes 53 weeks with each of the first three quarters having 13 weeks and the fourth quarter having 14 weeks. Fiscal year 2015 and 2014 included 52 weeks with each quarter having 13 weeks.
Net revenues for fiscal 2016 were flat compared to fiscal 2015. Without the effects of foreign exchange, net revenues increased 2.9% compared to fiscal 2015. Revenue increases in plasma and TEG disposables were offset by declines in blood center disposables and reduced surgical, OrthoPAT and equipment sales for the fiscal year ended April 2, 2016. The 53rd week in fiscal 2016 also contributed to the increase, as it accounted for 1.7% of additional revenue as compared to fiscal 2015.
Net revenues for fiscal 2015 decreased 3.0% compared to fiscal 2014. Without the effects of foreign exchange, net revenues decreased 1.3% over fiscal 2014. Revenue increases in plasma and TEG disposables were more than offset by declines in the whole blood disposables for the fiscal year ended March 28, 2015.
We recorded an operating loss in fiscal 2016, as compared to operating income in fiscal 2015. Operating income decreased for the fiscal year ended April 2, 2016 primarily as a result of the goodwill and other asset impairment charges recognized in the second half of fiscal 2016, as discussed above. This increase in operating expenses was partially offset by reductions in restructuring and transformation expenses of $27.5 million in fiscal 2016 as compared to fiscal 2015.
During fiscal 2015, operating income decreased 12.7% compared to fiscal 2014. Without the effects of foreign currency, operating income decreased 0.9% compared to fiscal 2014. Operating income decreased primarily due to lower whole blood disposables volume and pricing and the associated reduced manufacturing efficiency. These decreases were partially offset by reduced restructuring and transformation costs, and organizational cost savings initiatives. Restructuring and transformation costs were $66.8 million for fiscal 2015, as compared to $84.8 million for the comparative prior year period.
We recorded a net loss in fiscal 2016, as compared to net income in fiscal 2015. The change in net loss is primarily attributable to the decrease in operating income described above, partially offset by a decrease in the income tax provision in fiscal 2016 as compared to fiscal 2015.
Net income decreased 51.9% during fiscal 2015. Without the effects of foreign exchange, net income decreased 20.8% for fiscal 2015. The decrease in net income was primarily attributable to an increase in tax expense and the decrease in operating income described above. The increase in tax expense is attributable to the establishment of a valuation allowance for our U.S. net deferred tax assets following three years of cumulative losses directly related to our substantial restructuring and transformation spending.
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RESULTS OF OPERATIONS
Net Revenues by Geography
(In thousands) | April 2, 2016 | March 28, 2015 | March 29, 2014 | % Increase/(Decrease) 16 vs. 15 | % Increase/(Decrease) 15 vs. 14 | ||||||||||||
United States | $ | 519,440 | $ | 494,788 | $ | 500,719 | 5.0 | % | (1.2 | )% | |||||||
International | 389,392 | 415,585 | 437,790 | (6.3 | )% | (5.1 | )% | ||||||||||
Net revenues | $ | 908,832 | $ | 910,373 | $ | 938,509 | (0.2 | )% | (3.0 | )% | |||||||
International Operations and the Impact of Foreign Exchange
Our principal operations are in the U.S., Europe, Japan and other parts of Asia. Our products are marketed in approximately 100 countries around the world through a combination of our direct sales force and independent distributors and agents.
The percentage of revenue generated in our principle operating regions is summarized below:
April 2, 2016 | March 28, 2015 | March 29, 2014 | ||||||
United States | 57.1 | % | 54.4 | % | 53.4 | % | ||
Japan | 9.0 | % | 9.7 | % | 11.6 | % | ||
Europe | 20.7 | % | 23.7 | % | 24.0 | % | ||
Asia | 12.3 | % | 11.2 | % | 10.1 | % | ||
Other | 0.9 | % | 1.0 | % | 0.9 | % | ||
Total | 100.0 | % | 100.0 | % | 100.0 | % | ||
International sales are generally conducted in local currencies, primarily the Japanese Yen, the Euro, the Chinese Yuan and the Australian Dollar. Our results of operations are impacted by changes in foreign exchange rates, particularly in the value of the Yen, the Euro and Australian Dollar relative to the U.S. Dollar.
We have placed foreign currency hedges based on estimates of future revenues to reduce the impacts of currency fluctuations. For fiscal 2016 as compared to fiscal 2015, the effects of foreign exchange resulted in a 3.1% decrease in sales. The primary reason is the relative strength of the U.S. Dollar to the Japanese Yen and Euro. We expect this relative strength of the U.S. Dollar to continue to negatively impact operating income in fiscal 2017. For fiscal 2015 as compared to fiscal 2014, the effects of foreign exchange accounted for a 1.7% decrease in sales.
Please see section entitled “Foreign Exchange” in this discussion for a more complete explanation of how foreign currency affects our business and our strategy for managing this exposure.
Net Revenues by Product Type
(In thousands) | April 2, 2016 | March 28, 2015 | March 29, 2014 | % Increase/(Decrease) 16 vs. 15 | % Increase/(Decrease) 15 vs. 14 | ||||||||||||
Disposables | $ | 784,454 | $ | 783,426 | $ | 806,834 | 0.1 | % | (2.9 | )% | |||||||
Software solutions | 72,434 | 72,185 | 70,441 | 0.3 | % | 2.5 | % | ||||||||||
Equipment & other | 51,944 | 54,762 | 61,234 | (5.1 | )% | (10.6 | )% | ||||||||||
Net revenues | $ | 908,832 | $ | 910,373 | $ | 938,509 | (0.2 | )% | (3.0 | )% | |||||||
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Disposables Revenues by Product Type
(In thousands) | April 2, 2016 | March 28, 2015 | March 29, 2014 | % Increase/(Decrease) 16 vs. 15 | % Increase/(Decrease) 15 vs. 14 | ||||||||||||
Plasma disposables | $ | 348,785 | $ | 319,190 | $ | 291,895 | 9.3 | % | 9.4 | % | |||||||
Blood center disposables | |||||||||||||||||
Platelet | 143,274 | 152,588 | 156,643 | (6.1 | )% | (2.6 | )% | ||||||||||
Red cell | 39,256 | 42,700 | 42,378 | (8.1 | )% | 0.8 | % | ||||||||||
Whole blood | 128,532 | 143,905 | 190,698 | (10.7 | )% | (24.5 | )% | ||||||||||
311,062 | 339,193 | 389,719 | (8.3 | )% | (13.0 | )% | |||||||||||
Hospital disposables | |||||||||||||||||
Diagnostics | 50,882 | 42,187 | 33,302 | 20.6 | % | 26.7 | % | ||||||||||
Surgical | 59,902 | 62,540 | 66,876 | (4.2 | )% | (6.5 | )% | ||||||||||
OrthoPAT | 13,823 | 20,316 | 25,042 | (32.0 | )% | (18.9 | )% | ||||||||||
124,607 | 125,043 | 125,220 | (0.3 | )% | (0.1 | )% | |||||||||||
Total disposables revenues | $ | 784,454 | $ | 783,426 | $ | 806,834 | 0.1 | % | (2.9 | )% | |||||||
Disposables Revenues
Disposables include the Plasma, Blood Center, and Hospital product lines. Disposables revenue was flat during fiscal 2016 and decreased 2.9% during fiscal 2015. Without the effects of foreign exchange, disposables revenue increased 3.3% and decreased 1.1% for fiscal 2016 and 2015, respectively. In fiscal 2016, revenue increases in plasma and TEG disposables were offset by declines in sales of our blood center, surgical, and OrthoPAT disposables. In fiscal 2015, the decrease was primarily driven by significantly reduced whole blood disposables revenue and was partially offset by growth in plasma and TEG disposables revenue.
Plasma
Plasma disposables revenue increased 9.3% during fiscal 2016. Without the effects of foreign exchange, plasma disposables revenue increased 12.0% during fiscal 2016 compared to fiscal 2015. Plasma revenue increased principally due to higher volumes in the U.S. associated with end market growth for plasma-derived biopharmaceuticals. The implementation of a liquid solutions contract with a large U.S. collector and strong performance in Japan and other parts of Asia also contributed to growth. This growth was partially offset by reductions related to market conditions in Russia.
Plasma disposables revenue increased 9.4% during fiscal 2015. Without the effects of foreign exchange, plasma disposables revenue increased 10.4% during fiscal 2015. Plasma revenue increased due to higher volumes in the United States associated with end market growth for plasma-derived biopharmaceuticals and benefits from the transition to a direct sales model in Australia and New Zealand which occurred in the second quarter of fiscal 2014.
Blood Center
Platelet
While we market our platelets products globally, the dynamics of each market are significantly different. Despite modest increases in the demand for platelets in Europe and Japan, improved collection efficiencies that increase the yield of platelets per collection and more efficient use of collected platelets have resulted in a flat market for automated collections and related disposables in these countries. In particular, the use of "double dose" collection methods in Europe and Japan has increased. Double dose collections involve collecting two therapeutic platelet doses from one donor. Competition in double dose collection technology is intense and has negatively impacted our sales in a number of markets where these collections are prevalent. Most recently in Japan, our market share gains in single dose collections have been offset by the recent adoption of double dose collections by our primary customer. Increased use of double dose collections in Japan may negatively impact our revenue and gross profit from platelet collection disposables in that market.
In addition to the impact of different collection techniques, emerging markets have seen changes in healthcare and social security systems which have allowed increased access to advanced medical treatment. This has driven the demand for platelet transfusions and increased collection volumes. In emerging markets, particular Russia, we have also seen economic instability negatively impact healthcare spend and our revenue.
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Platelet disposables revenue decreased 6.1% during fiscal 2016. Without the effects of foreign exchange, platelet disposable revenue decreased 0.8% during fiscal 2016. The decrease in platelet disposable revenue during fiscal 2016, excluding the impact of foreign exchange, was primarily the result of declines in sales in Russia and Latin America. These declines were partially offset by growth in China, India, the Middle East, and other parts of Asia.
Platelet disposables revenue decreased 2.6% during fiscal 2015. Without the effects of foreign exchange, platelet disposable revenue increased 3.0% during fiscal 2015. Without the effect of foreign exchange, the increase was due to growth in emerging markets and the benefit of order timing in North America offset by the impact of the collection trends in Japan noted above.
Red Cells and Whole Blood
Red cell disposables revenue decreased 8.1% during fiscal 2016. Without the effects of foreign exchange, red cell disposables revenue decreased 7.0% during fiscal 2016. The decrease during fiscal 2016 was driven by price reductions in our principal U.S. red cell market. During fiscal 2016, U.S. blood collection groups pursued arrangements for apheresis red cell collections with the objective of standardizing their collection technology and securing price reductions. These arrangements are now largely in place and began to negatively affect red cell revenues and gross margins during the second quarter of fiscal 2016.
As discussed above, during the second quarter of fiscal 2016, we entered into a contract with the American Red Cross which included an incentive to transition to our technology and price reductions tied to higher volumes. In addition, Blood Center GPOs have selected competitive technologies. We expect revenue to decline from both the lower pricing in the American Red Cross contract and the conversion by Blood Center GPOs to the competitive technologies. Red cell disposable revenues in the U.S. totaled $34.8 million and $37.6 million during fiscal 2016 and 2015, respectively.
Red cell disposables revenue increased 0.8% during fiscal 2015. Without the effects of foreign exchange, red cell disposables revenue increased 0.8% during fiscal 2015. The increase was driven by North American sales due to changes in red cell collection practices and was partially offset by declines in Europe and Latin America. During fiscal 2015, we saw a modest shift in order patterns from whole blood to red cell disposables due to customer efforts to more efficiently collect red cells.
Whole blood revenue decreased 10.7% during fiscal 2016. Without the effect of foreign exchange, whole blood revenue decreased 8.3% during fiscal 2016. Whole blood disposables revenue for fiscal 2016 decreased primarily due to a declining U.S. whole blood market. The anniversary of the loss of the American Red Cross whole blood business occurred at the end of the first quarter of fiscal 2016, however, we continue to be negatively impacted by the declining market.
Whole blood revenue decreased 24.5% during fiscal 2015. Without the effect of foreign exchange, whole blood revenue decreased 24.1% during fiscal 2015, due to the loss of the American Red Cross business, lower pricing to HemeXcel, the loss of a European tender early in fiscal 2014 and macro-economic conditions in Russia. Declines in North American transfusion rates of 10% contributed approximately $8.0 million to the fiscal 2015 decline.
Hospital
Diagnostics
Diagnostics product revenue consists principally of the consumable reagents used with the TEG hemostasis management family of products. Revenue from diagnostic products increased 20.6% during fiscal 2016. Without the effect of foreign exchange, diagnostic product revenue increased 20.2%. The revenue increase is due to continued adoption of our hemostasis system, principally in the U.S. and China. We are continuing our limited market release of the TEG 6s device and disposables.
Revenue from our diagnostic products increased 26.7% during fiscal 2015. Without the effect of foreign exchange, diagnostic product revenue increased 23.4%. The revenue increase is due to continued adoption of our TEG analyzer, principally in the United States and China.
Surgical
Surgical disposables revenue consists principally of the Cell Saver and CardioPAT products. Revenue from our surgical disposables decreased 4.2% during fiscal 2016. Without the effect of foreign exchange, surgical disposables revenue increased 1.0% during fiscal 2016. The increase in surgical disposable revenue was primarily attributable to modest growth in Japan and in the emerging markets in Russia and China.
Revenue from our surgical disposables decreased 6.5% during fiscal 2015. Without the effect of foreign exchange, surgical disposables revenue decreased 3.3% during fiscal 2015. The decline in surgical revenue in developed markets was partially offset by growth in emerging markets.
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OrthoPAT
Revenue from our OrthoPAT disposables decreased 32.0% during fiscal 2016. Without the effect of foreign exchange, OrthoPAT disposables revenue decreased 27.5%. Better blood management has reduced orthopedic blood loss and continues to impact demand for OrthoPAT disposables. Recent trends in blood management, particularly the adoption of tranexamic acid to treat and prevent orthopedic post-operative blood loss, continue to lessen hospital use of OrthoPAT disposables. During fiscal 2016, OrthoPAT disposable revenues were also negatively impacted by a supply chain interruption. We expect continued declines in OrthoPAT revenues in fiscal 2017.
Revenue from our OrthoPAT disposables decreased 18.9% during fiscal 2015. Without the effect of foreign exchange, OrthoPAT disposables revenue decreased 16.5% as better blood management has reduced orthopedic blood loss and demand for OrthoPAT disposables. Recent trends in blood management, particularly the adoption of tranexamic acid to treat and prevent orthopedic post-operative blood loss, have continued to reduce hospital use of OrthoPAT disposables.
Other Revenues
(In thousands) | April 2, 2016 | March 28, 2015 | March 29, 2014 | % Increase/(Decrease) 16 vs. 15 | % Increase/(Decrease) 15 vs. 14 | ||||||||||||
Software solutions | $ | 72,434 | $ | 72,185 | $ | 70,441 | 0.3 | % | 2.5 | % | |||||||
Equipment and other | 51,944 | 54,762 | 61,234 | (5.1 | )% | (10.6 | )% | ||||||||||
Net other revenues | $ | 124,378 | $ | 126,947 | $ | 131,675 | (2.0 | )% | (3.6 | )% | |||||||
Software Solutions
Our software solutions revenue includes sales of our information technology software platforms and consulting services.
Software solutions revenue was flat during fiscal 2016. Without the effects of foreign exchange, software solutions revenue increased 2.7% during fiscal 2016. The growth in software revenues in fiscal 2016 was driven by the finalization of services under a contract with the Department of Defense, the recognition of previously deferred revenue associated with one of our largest customers, BloodTrack growth in Europe, and increased software support service revenue. This growth was partially offset by declines in BloodTrack in the U.S. and lower new system installs in Europe.
Software solutions revenue increased 2.5% during fiscal 2015. Without the effects of foreign exchange, software solutions revenue increased 2.9% during fiscal 2015. During fiscal 2015, software revenue increased due to strong BloodTrack sales in the U.S. and Europe.
Equipment & Other
Our equipment and other revenues include revenue from equipment sales, repairs performed under preventive maintenance contracts or emergency service visits, spare part sales, and various service and training programs. These revenues are primarily composed of equipment sales, which tend to vary from period to period more than our disposable product line due to the timing of order patterns, particularly in our distribution markets.
Equipment and other revenue decreased 5.1% during fiscal 2016. Without the effects of currency exchange, equipment and other revenue decreased 1.9%. The decrease in revenue was primarily due to a rebate assessed by the Italian government and declines in Russia and Japan. The decline in Russia was due to the Russian market suspending all equipment purchasing in fiscal 2016 and the decline in Japan was a result of lower platelet equipment sales. These declines were partially offset by increases in red cell equipment revenue in the U.S. and plasma equipment revenue in Germany.
Equipment and other revenue decreased 10.6% during fiscal 2015. Without the effect of currency exchange, equipment and other revenue decreased 8.7%. The decrease in revenue during fiscal 2015 is due primarily to the impact of order timing and macro-economic conditions in Russia.
Gross Profit
(In thousands) | April 2, 2016 | March 28, 2015 | March 29, 2014 | % Increase/(Decrease) 16 vs. 15 | % Increase/(Decrease) 15 vs. 14 | ||||||||||||
Gross profit | $ | 405,914 | $ | 434,418 | $ | 468,365 | (6.6 | )% | (7.2 | )% | |||||||
% of net revenues | 44.7 | % | 47.7 | % | 49.9 | % | |||||||||||
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Our gross profit decreased 6.6% during fiscal 2016. Without the effects of foreign exchange, gross profit decreased 2.0% during fiscal 2016. Our gross profit margin percentage decreased by 300 basis points for fiscal 2016 as compared to fiscal 2015. The decrease in the gross profit margin during fiscal 2016 was primarily due to the effect of foreign exchange, inventory related charges of $9.4 million and impairment of assets of $8.8 million. Product mix, including plasma disposables, price reductions in our blood center business, and the amortization of software development costs in the early stages of product launches also negatively impacted gross profit. These declines were partially offset by cost savings from productivity programs, including the VCC initiatives. Gross profit margin continues to be impacted by the inefficiency of underutilized production capacity.
Our gross profit amount decreased 7.2% during fiscal 2015. Without the effects of foreign exchange, gross profit decreased 5.1% during fiscal 2015. Our gross profit margin percentage decreased by 220 basis points for fiscal 2015 as compared to fiscal 2014. The decrease in gross profit margin for the fiscal year ended March 28, 2015 was primarily due to price reductions in the blood collection markets, reduced manufacturing efficiency related to lower whole blood volumes and relatively higher sales from products with lower gross margins. These decreases were partially offset by cost savings from our VCC initiatives implemented during fiscal 2014 and 2015.
Operating Expenses
(In thousands) | April 2, 2016 | March 28, 2015 | March 29, 2014 | % Increase/(Decrease) 16 vs. 15 | % Increase/(Decrease) 15 vs. 14 | ||||||||||||
Research and development | $ | 44,965 | $ | 54,187 | $ | 54,200 | (17.0 | )% | — | % | |||||||
% of net revenues | 4.9 | % | 6.0 | % | 5.8 | % | |||||||||||
Selling, general and administrative | $ | 317,223 | $ | 337,168 | $ | 365,977 | (5.9 | )% | (7.9 | )% | |||||||
% of net revenues | 34.9 | % | 37.0 | % | 39.0 | % | |||||||||||
Impairment of assets | $ | 92,395 | $ | 5,441 | $ | 1,711 | n/m | 218.0 | % | ||||||||
% of net revenues | 10.2 | % | 0.6 | % | 0.2 | % | |||||||||||
Contingent consideration (income) expense | $ | (4,727 | ) | $ | (2,918 | ) | $ | 45 | 62.0 | % | n/m | ||||||
% of net revenues | (0.5 | )% | (0.3 | )% | — | % | |||||||||||
Total operating expenses | $ | 449,856 | $ | 393,878 | $ | 421,933 | 14.2 | % | (6.6 | )% | |||||||
% of net revenues | 49.5 | % | 43.3 | % | 45.0 | % | |||||||||||
Research and Development
Research and development expenses decreased 17.0% during fiscal 2016. Without the effects of foreign exchange, research and development expenses decreased 15.7% during fiscal 2016. The decrease in fiscal 2016 was primarily the result of a reduction in restructuring and transformation costs of $10.9 million, partially offset by increased activities for several projects designed to support our long-term product plans and to increase our competitiveness.
Research and development expenses remained flat during fiscal 2015. Without the effect of the increased restructuring and transformation costs of $2.8 million in fiscal 2015, as compared to the prior year, research and development decreased by approximately 6.0% as a result of reduced program spending related to the whole blood acquisition.
Selling, General and Administrative
During fiscal 2016, selling, general and administrative expenses decreased 5.9%. Without the effects of foreign exchange, selling, general and administrative expenses decreased 2.3% during fiscal 2016. The decrease in fiscal 2016 was primarily the result of reductions in restructuring and transformation costs of $12.8 million and decreased variable compensation. The decrease was partially offset by increased spending in sales and marketing activities related to plasma and increased spending as a result of the extra week in fiscal 2016.
During fiscal 2015, selling, general and administrative expenses decreased 7.9%. Without the effects of foreign exchange, selling, general and administrative expenses decreased 6.4% during fiscal 2015. The decrease during fiscal 2015 is primarily related to a $20.1 million decrease in restructuring and transformation costs related to VCC initiatives. This decrease was partially offset by our increased commercial investment in plasma and emerging markets and increased variable compensation.
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Impairment of Assets
We recorded asset impairments of $92.4 million in fiscal 2016 primarily consisting of $66.3 million of goodwill impairment, $19.2 million of intangible asset impairments and $6.9 million of property, plant and equipment impairments, as discussed in the Recent Developments section above.
We recorded asset impairments of $5.4 million in fiscal 2015 associated with exit activities related to our VCC initiatives and certain research and development programs.
We recorded asset impairments of $1.7 million in the fourth quarter of fiscal 2014 associated with exit activities related to our VCC and integration initiatives.
Other Expense, Net
Other expense, net, increased 1.1% during fiscal 2016 as compared to fiscal 2015 and decreased 6.5% during fiscal 2015 as compared to fiscal 2014. Interest expense from our term loan borrowings constitutes the majority of expense reported in all periods. The effective interest rate on total debt outstanding for the fiscal year ended April 2, 2016 was approximately 1.9%.
Taxes
April 2, 2016 | March 28, 2015 | March 29, 2014 | % Increase/(Decrease) 16 vs. 15 | % Increase/(Decrease) 15 vs. 14 | ||||||||||
Reported income tax rate | (4.0 | )% | 45.8 | % | 3.4 | % | (49.8 | )% | 42.4 | % | ||||
Reported Tax Rate
We conduct business globally and as a result report our results of operations in a number of foreign jurisdictions and the United States. Historically, our reported tax rate was lower than the U.S. statutory tax rate due primarily to our jurisdictional mix of earnings as the income earned in our foreign subsidiaries is generally taxed at a lower tax rate. In fiscal 2015 we established a valuation allowance against a portion of our U.S. deferred tax assets that are not more-likely-than-not realizable due to cumulative losses in the U.S. In fiscal 2016 we continue to maintain a partial valuation allowance against our net U.S. deferred tax assets and net deferred tax assets of certain foreign subsidiaries.
For the year ended April 2, 2016, we recorded an income tax provision of $2.2 million for our worldwide pre-tax loss of $53.4 million, resulting in a reported tax rate of (4.0)%. Our current tax rate is lower than our tax rates of 45.8% and 3.4% for the years ended March 28, 2015 and March 29, 2014, respectively. Our decrease in tax rate is primarily as a result of domestic losses of $18.1 million and foreign losses of $10.8 million for which no tax benefit can be realized. In addition, we recorded income tax expense related to the amortization of U.S. tax-deductible goodwill, which generates a deferred tax liability that cannot be offset by net operating losses or other deferred tax assets as its reversal is considered indefinite in nature.
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Liquidity and Capital Resources
The following table contains certain key performance indicators we believe depict our liquidity and cash flow position:
(In thousands) | April 2, 2016 | March 28, 2015 | |||||
Cash & cash equivalents | $ | 115,123 | $ | 160,662 | |||
Working capital | $ | 302,535 | $ | 368,985 | |||
Current ratio | 2.6 | 3.0 | |||||
Net debt position(1) | $ | (292,877 | ) | $ | (267,229 | ) | |
Days sales outstanding (DSO) | 58 | 58 | |||||
Disposables finished goods inventory turnover | 4.6 | 4.3 | |||||
(1)Net debt position is the sum of cash and cash equivalents less total debt.
Our VCC initiatives required cash expenditures for plant closure costs and employee separation benefits, new plant construction and temporary increases in inventory levels as manufacturing is transitioned to new facilities. We paid $51.3 million, $114.3 million and $72.9 million in cash related to restructuring costs, transformation costs and capital expenditures associated with the VCC initiatives during fiscal 2016, 2015 and 2014, respectively. In fiscal 2017, we expect to incur approximately $26 million of restructuring and transformation charges in connection with the first phase of our restructuring program that was launched during the first quarter of fiscal 2017, which is designed to reposition our organization and improve our cost structure.
As of April 2, 2016, we had $115.1 million in cash and cash equivalents. We currently have a credit facility which provides for a $475.0 million term loan and a $100.0 million revolving loan. The credit facility matures on July 1, 2019. At April 2, 2016, $358.1 million was outstanding under the term loan and $50.0 million was outstanding on the revolving loan. We also have $45.1 million of uncommitted operating lines of credit to fund our global operations and there are no outstanding borrowings as of April 2, 2016.
The credit facility contains covenants that limit the use of cash and require us to maintain certain financial ratios. Any failure to comply with the financial and or other operating covenants of the credit facility would prevent us from borrowing under the revolving credit facility and would constitute a default, which could result in, among other things, the amounts outstanding including all accrued interest and unpaid fees, becoming immediately due and payable. As of April 2, 2016, we were in compliance with all covenants.
Our primary sources of liquidity are cash and cash equivalents, internally generated cash flow from operations and option exercises. Although cash flow from operations will be negatively impacted by the trends noted above, we believe these sources are sufficient to fund our cash requirements over at least the next twelve months, which are primarily payments associated with restructuring initiatives, share repurchases, capital expenditures, cash payments under the loan agreement, investments and other acquisitions. These are described in more detail in Contractual Obligations below.
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Cash Flow Overview:
(In thousands) | April 2, 2016 | March 28, 2015 | March 29, 2014 | Increase/(Decrease) 16 vs. 15 | Increase/(Decrease) 15 vs. 14 | ||||||||||||||
Net cash provided by (used in): | |||||||||||||||||||
Operating activities | $ | 121,865 | $ | 127,178 | $ | 139,524 | $ | (5,313 | ) | $ | (12,346 | ) | |||||||
Investing activities | (104,768 | ) | (121,768 | ) | (105,830 | ) | (17,000 | ) | 15,938 | ||||||||||
Financing activities | (62,624 | ) | (33,160 | ) | (20,699 | ) | 29,464 | 12,461 | |||||||||||
Effect of exchange rate changes on cash and cash equivalents(1) | (12 | ) | (4,057 | ) | 354 | 4,045 | (4,411 | ) | |||||||||||
Net (decrease)/increase in cash and cash equivalents | $ | (45,539 | ) | $ | (31,807 | ) | $ | 13,349 | |||||||||||
(1)The balance sheet is affected by spot exchange rates used to translate local currency amounts into U.S. dollars. In accordance with U.S. GAAP, we have eliminated the effect of foreign currency throughout our cash flow statement, except for its effect on our cash and cash equivalents.
Operating Activities:
Net cash provided by operating activities was $121.9 million during fiscal 2016, a decrease of $5.3 million as compared to fiscal 2015. Cash provided by operating activities decreased primarily due to a working capital outflow. The working capital outflow was primarily attributable to a decrease in accounts payable and accrued expenses, driven largely by a reduction in restructuring reserves, accrued bonuses, accruals related to the construction of facilities and licensing agreements, and a decrease in accrued payroll due to the 53rd week. Also contributing to the reduction in cash provided by operating activities was an increase in accounts receivable from fiscal 2015 to fiscal 2016. The decrease in cash provided by operating activities was partially offset by lower inventory driven by our global strategic review, which included a global inventory reduction initiative during fiscal 2016.
Net cash provided by operating activities was $127.2 million during fiscal 2015, a decrease of $12.3 million as compared to fiscal 2014 primarily due to lower earnings.
Investing Activities:
Net cash used in investing activities was $104.8 million during fiscal 2016, a decrease of $17.0 million as compared to fiscal 2015. The decrease in cash used in investing activities was the result of a reduction in capital expenditures in fiscal 2016 related to manufacturing operations under construction in Malaysia and Tijuana, which have been substantially completed. During fiscal 2015, cash used in investing activities included significant costs related to plant construction activities in Malaysia and Tijuana and the purchase of two previously leased facilities, our manufacturing facility in Salt Lake City and an administrative office at our corporate headquarters in Braintree, Massachusetts.
Net cash used in investing activities was $121.8 million during fiscal 2015, an increase of $15.9 million as compared to fiscal 2014 primarily due to $122.2 million of capital expenditures including $44.9 million related to our manufacturing network transformation activities. The increase was partially offset by a reduction in acquisition related investments of $32.7 million in fiscal 2014.
Financing Activities:
Net cash used in financing activities was $62.6 million during fiscal 2016, an increase of $29.5 million as compared to fiscal 2015 primarily due to $61.0 million of share repurchases during fiscal 2016 compared to $39.0 million of share repurchases during fiscal 2015. Higher term loan payments of $12.8 million also contributed to the increase. This was partially offset by an increase in short-term loans and an increase in proceeds from the exercise of stock options.
Net cash used in financing activities was $33.2 million during fiscal 2015, a decrease of $12.5 million as compared to fiscal 2014 primarily due to $39.0 million used to repurchase approximately 1.2 million shares of common stock. The increase was partially offset by reduced payments towards the term loan in fiscal 2015.
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Contractual Obligations
A summary of our contractual and commercial commitments as of April 2, 2016, is as follows:
Payments Due by Period | |||||||||||||||||||
(In thousands) | Total | Less than 1 year | 1-3 years | 3-5 years | More than 5 years | ||||||||||||||
Debt | $ | 408,000 | $ | 43,471 | $ | 195,980 | $ | 168,549 | $ | — | |||||||||
Operating leases | 20,822 | 4,845 | 6,306 | 3,528 | 6,143 | ||||||||||||||
Purchase commitments* | 103,316 | 98,607 | 4,709 | — | — | ||||||||||||||
Expected retirement plan benefit payments | 16,253 | 1,746 | 3,065 | 3,570 | 7,872 | ||||||||||||||
Employee related commitments | 9,238 | 8,568 | 670 | — | — | ||||||||||||||
Total contractual obligations | $ | 557,629 | $ | 157,237 | $ | 210,730 | $ | 175,647 | $ | 14,015 | |||||||||
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* | Includes amounts we are committed to spend on purchase orders entered in the normal course of business for capital equipment and for the purpose of manufacturing our products including contract manufacturers, specifically JMS Co. Ltd., Kawasumi Laboratories and Sanmina Corporation for the manufacture of certain disposable products and equipment. The majority of our operating expense spending does not require any advance commitment. | |
The above table does not reflect our long-term liabilities associated with unrecognized tax benefits of $2.3 million recorded in accordance with ASC Topic 740, Income Taxes. We cannot reasonably make a reliable estimate of the period in which we expect to settle these long-term liabilities due to factors outside of our control, such as tax examinations.
We anticipate paying an additional $17.8 million upon replication and delivery of certain manufacturing assets of Pall's filter media business to Haemonetics by fiscal 2018.
Concentration of Credit Risk
Concentrations of credit risk with respect to trade accounts receivable are generally limited due to our large number of customers and their diversity across many geographic areas. A portion of our trade accounts receivable outside the United States, however, include sales to government-owned or supported healthcare systems in several countries, which are subject to payment delays. Payment is dependent upon the financial stability and creditworthiness of those countries' national economies.
Although we have not incurred significant losses on government receivables to date, we continually evaluate all government receivables for potential collection risks associated with the availability of government funding and reimbursement practices. If the financial condition of customers or the countries' healthcare systems deteriorate such that their ability to make payments is uncertain, allowances may be required in future periods.
Legal Proceedings
We are presently engaged in various legal actions, and although our ultimate liability cannot be determined at the present time, we believe, based on consultation with counsel, that any such liability will not materially affect our consolidated financial position or our results of operations.
Italian Employment Litigation
Our Italian manufacturing subsidiary is party to several actions initiated by employees of the facility in Ascoli-Piceno, Italy where we have ceased manufacturing operations. These include actions claiming (i) working conditions and minimum salaries should have been established by either a different classification under their national collective bargaining agreement or a different agreement altogether, (ii) certain solidarity agreements, which are arrangements between the Company, employees and the government to continue full pay and benefits for employees who would otherwise be terminated in times of low demand, are void, and (iii) payment of the extra time used for changing into and out of the working clothes at the beginning and end of each shift.
In addition, a union represented in the Ascoli plant has filed an action claiming that the Company discriminated against it in favor of three other represented unions by (i) interfering with an employee referendum, (ii) interfering with an employee petition to recall union representatives from office, and (iii) excluding the union from certain meetings.
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Finally, we have been added as defendants on claims filed against Pall Corporation prior to our acquisition of the plant in August 2012. These claims relate to agreements to "freeze" benefit allowances for a certain period in exchange for Pall's commitments on hiring and plant investment.
As of April 2, 2016, the total amount of damages claimed by the plaintiffs in these matters is approximately $4.6 million; however, it is not possible at this point in the proceedings to accurately evaluate the likelihood or amount of any potential losses. We may receive other similar claims in the future.
Inflation
We do not believe that inflation had a significant impact on our results of operations for the periods presented. Historically, we believe we have been able to mitigate the effects of inflation by improving our manufacturing and purchasing efficiencies, by increasing employee productivity, and by adjusting the selling prices of products. We continue to monitor inflation pressures generally and raw materials indices that may affect our procurement and production costs. Increases in the price of petroleum derivatives could result in corresponding increases in our costs to procure plastic raw materials.
Foreign Exchange
During fiscal 2016, 42.9% of our sales were generated outside the U.S., generally in foreign currencies, yet our reporting currency is the U.S. Dollar. We also incur certain manufacturing, marketing and selling costs in international markets in local currency. Our primary foreign currency exposures relate to sales denominated in Euro, Japanese Yen, Chinese Yuan and Australian Dollars. We also have foreign currency exposure related to manufacturing and other operational costs denominated in Swiss Francs, British Pounds, Canadian Dollars and Mexican Pesos. The Yen, Euro, Yuan and Australian Dollar sales exposure is partially mitigated by costs and expenses for foreign operations and sourcing products denominated in foreign currencies. Since our foreign currency denominated Yen, Euro, Yuan and Australian Dollar sales exceed the foreign currency denominated costs, whenever the U.S. Dollar strengthens relative to the Yen, Euro, Yuan or Australian Dollar, there is an adverse effect on our results of operations and, conversely, whenever the U.S. Dollar weakens relative to the Yen, Euro, Yuan or Australian Dollar, there is a positive effect on our results of operations. For Swiss Francs, British Pounds, Canadian Dollars and Mexican Pesos, our primary cash flows relate to product costs or costs and expenses of local operations. Whenever the U.S. Dollar strengthens relative to these foreign currencies, there is a positive effect on our results of operations. Conversely, whenever the U.S. Dollar weakens relative to these currencies, there is an adverse effect on our results of operations.
We have a program in place that is designed to mitigate our exposure to changes in foreign currency exchange rates. That program includes the use of derivative financial instruments to minimize, for a period of time, the unforeseen impact on our financial results from changes in foreign exchange rates. We utilize forward foreign currency contracts to hedge the anticipated cash flows from transactions denominated in foreign currencies, primarily Japanese Yen and Euro, and to a lesser extent Swiss Francs, British Pounds, Australian Dollars, Canadian Dollars and Mexican Pesos. This does not eliminate the volatility of foreign exchange rates, but because we generally enter into forward contracts one year out, rates are fixed for a one-year period, thereby facilitating financial planning and resource allocation.
These contracts are designated as cash flow hedges. The final impact of currency fluctuations on the results of operations is dependent on the local currency amounts hedged and the actual local currency results.
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Presented below are the spot rates for our Euro, Japanese Yen, Australian Dollar, Canadian Dollar, British Pound, Swiss Franc and Mexican Peso cash flow hedges that settled during fiscal years 2014, 2015 and 2016 or are presently outstanding. These hedges cover our long foreign currency positions that result from our sales designated in Euro, Japanese Yen and Australian Dollars. These hedges include our short positions associated with costs incurred in Canadian Dollars, British Pounds, Swiss Francs and Mexican Pesos. The table shows how the strengthening or weakening of the spot rates associated with those hedge contracts versus the spot rates in the contracts that settled in the prior comparable period affects our results favorably or unfavorably. The table assumes a consistent notional amount for hedge contracts in each period presented.
First Quarter | Favorable / (Unfavorable) | Second Quarter | Favorable / (Unfavorable) | Third Quarter | Favorable / (Unfavorable) | Fourth Quarter | Favorable / (Unfavorable) | |||||||||||||||||
Sales Hedges | ||||||||||||||||||||||||
Euro - Hedge Spot Rate (USD per Euro) | ||||||||||||||||||||||||
FY14 | 1.27 | (11 | )% | 1.25 | (12 | )% | 1.29 | (5 | )% | 1.33 | 1 | % | ||||||||||||
FY15 | 1.33 | 5 | % | 1.35 | 8 | % | 1.35 | 5 | % | 1.37 | 3 | % | ||||||||||||
FY16 | 1.35 | 2 | % | 1.29 | (4 | )% | 1.25 | (8 | )% | 1.13 | (18 | )% | ||||||||||||
FY17 | 1.09 | (19 | )% | 1.11 | (14 | )% | 1.06 | (15 | )% | 1.11 | (2 | )% | ||||||||||||
Japanese Yen - Hedge Spot Rate (JPY per USD) | ||||||||||||||||||||||||
FY14 | 79.85 | (1 | )% | 79.68 | (4 | )% | 84.32 | (9 | )% | 93.92 | (19 | )% | ||||||||||||
FY15 | 97.16 | (22 | )% | 98.18 | (23 | )% | 101.09 | (20 | )% | 102.44 | (9 | )% | ||||||||||||
FY16 | 102.05 | (5 | )% | 106.84 | (9 | )% | 118.46 | (17 | )% | 117.25 | (14 | )% | ||||||||||||
FY17 | 124.07 | (22 | )% | 122.18 | (14 | )% | 122.99 | (4 | )% | 113.55 | 3 | % | ||||||||||||
Australian Dollar - Hedge Spot Rate (USD per AUD) | ||||||||||||||||||||||||
FY14 | — | — | % | 0.92 | — | % | 0.91 | — | % | 0.92 | — | % | ||||||||||||
FY15 | 0.90 | — | % | 0.94 | 3 | % | 0.94 | 3 | % | 0.90 | (2 | )% | ||||||||||||
FY16 | 0.94 | 4 | % | 0.91 | (3 | )% | 0.85 | (10 | )% | 0.79 | (12 | )% | ||||||||||||
FY17 | 0.76 | (18 | )% | 0.73 | (20 | )% | 0.72 | (15 | )% | 0.75 | (5 | )% | ||||||||||||
Operating Hedges | ||||||||||||||||||||||||
Canadian Dollar - Hedge Spot Rate (CAD per USD) | ||||||||||||||||||||||||
FY14 | 1.01 | 3 | % | 1.00 | 1 | % | 1.00 | (1 | )% | 1.01 | 1 | % | ||||||||||||
FY15 | — | — | % | — | — | % | 1.08 | 8 | % | 1.09 | 8 | % | ||||||||||||
FY16 | 1.13 | — | % | 1.14 | — | % | 1.17 | 9 | % | 1.25 | 14 | % | ||||||||||||
FY17 | 1.24 | 10 | % | 1.31 | 15 | % | 1.35 | 15 | % | 1.32 | 6 | % | ||||||||||||
British Pound - Hedge Spot Rate (USD per GBP) | ||||||||||||||||||||||||
FY14 | 1.59 | 2 | % | 1.55 | 5 | % | 1.52 | 5 | % | 1.54 | 2 | % | ||||||||||||
FY15 | 1.56 | 2 | % | 1.57 | (1 | )% | 1.62 | (7 | )% | 1.65 | (7 | )% | ||||||||||||
FY16 | 1.64 | (5 | )% | 1.57 | — | % | 1.57 | 3 | % | 1.53 | 7 | % | ||||||||||||
FY17 | 1.55 | 5 | % | — | — | % | — | — | % | — | — | % | ||||||||||||
Swiss Franc - Hedge Spot Rate (CHF per USD) | ||||||||||||||||||||||||
FY14 | 0.96 | 17 | % | 0.95 | 12 | % | 0.92 | — | % | 0.93 | 1 | % | ||||||||||||
FY15 | 0.94 | (2 | )% | 0.92 | (3 | )% | 0.90 | (2 | )% | 0.89 | (4 | )% | ||||||||||||
FY16 | 0.90 | (5 | )% | 0.95 | 3 | % | 0.94 | 4 | % | 0.92 | 3 | % | ||||||||||||
FY17 | 0.93 | 4 | % | 0.97 | 2 | % | 1.01 | 7 | % | 0.98 | 7 | % | ||||||||||||
Mexican Peso - Hedge Spot Rate (MXN per USD) | ||||||||||||||||||||||||
FY14 | 12.34 | — | % | 12.35 | — | % | 12.22 | — | % | 12.20 | — | % | ||||||||||||
FY15 | 12.40 | 1 | % | 13.06 | 6 | % | 13.09 | 7 | % | 13.08 | 7 | % | ||||||||||||
FY16 | 13.10 | 6 | % | 13.07 | — | % | 13.63 | 4 | % | 14.46 | 11 | % | ||||||||||||
FY17 | 15.20 | 16 | % | 15.73 | 20 | % | 16.71 | 23 | % | 17.27 | 19 | % | ||||||||||||
FY18 | 17.44 | 15 | % | — | — | % | — | — | % | — | — | % | ||||||||||||
_______________________________________
We generally place our cash flow hedge contracts on a rolling twelve month basis. |
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Recent Accounting Pronouncements
See Note 2, Summary of Significant Accounting Policies to our consolidated financial statements contained in Item 8 of this Annual Report on Form 10-K for additional information on Standards Implemented and Standards to be Implemented.
Critical Accounting Policies
Our significant accounting policies are summarized in Note 2 of our consolidated financial statements. While all of these significant accounting policies impact our financial condition and results of operations, we view certain of these policies as critical. Policies determined to be critical are those policies that have the most significant impact on our financial statements and require management to use a greater degree of judgment and/or estimates. Actual results may differ from those estimates.
The accounting policies identified as critical are as follows:
Revenue Recognition
Our revenue recognition policy is to recognize revenues from product sales, software and services in accordance with ASC Topic 605, Revenue Recognition, and ASC Topic 985-605, Software. These standards require that revenues are recognized when persuasive evidence of an arrangement exists, product delivery, including customer acceptance, has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. We may have multiple contracts with the same customer and each contract is typically treated as a separate arrangement. When more than one element such as equipment, disposables, and services are contained in a single arrangement, we allocate revenue between the elements based on each element’s relative selling price, provided that each element meets the criteria for treatment as a separate unit of accounting. An item is considered a separate unit of accounting if it has value to the customer on a stand-alone basis. The selling price of the undelivered elements is determined by the price charged when the element is sold separately, or in cases when the item is not sold separately, by third-party evidence of selling price or by management's best estimate of selling price. For our software arrangements accounted for under the provisions of ASC 985-605, Software, we establish fair value of undelivered elements based upon vendor specific objective evidence.
We generally do not allow our customers to return products. We offer sales rebates and discounts to certain customers. We treat sales rebates and discounts as a reduction of revenue and classify the corresponding liability as current. We estimate rebates for products where there is sufficient historical information available to predict the volume of expected future rebates. If we are unable to estimate the expected rebates reasonably, we record a liability for the maximum potential rebate or discount that could be earned. In circumstances where we provide upfront rebate payments to customers, we capitalize the rebate payments and amortize the resulting asset as a reduction of revenue using a systematic method over the life of the contract.
We generally recognize revenue from the sale of perpetual licenses on a percentage-of-completion basis which requires us to make reasonable estimates of the extent of progress toward completion of the contract. These arrangements most often include providing customized implementation services to our customer. We also provide other services, including in some instances hosting, technical support, and maintenance, for the payment of periodic, monthly, or quarterly fees. We recognize these fees and charges as earned, typically as these services are provided during the contract period.
Goodwill and Intangible Assets
Goodwill represents the excess purchase price over the fair value of the net tangible and other identifiable intangible assets acquired. Goodwill is not amortized. Instead goodwill is reviewed for impairment at least annually in accordance with ASC Topic 350, Intangibles - Goodwill and Other ("Topic 350"), or on an interim basis between annual tests when events or circumstances indicate that it is more likely than not that the fair value of a reporting unit is less than its carrying value. We perform our annual impairment test on the first day of the fiscal fourth quarter for each of our reporting units.
In performing our goodwill impairment assessment, we utilize the two-step approach prescribed under Topic 350. The first step requires a comparison of the carrying value of the reporting units, as defined, to the fair value of these units. We assess goodwill for impairment at the reporting unit level, which is defined as an operating segment or one level below an operating segment, referred to as a component. We determine our reporting units by first identifying our operating segments, and then assess whether any components of these segments constitute a business for which discrete financial information is available and where segment management regularly reviews the operating results of that component. We aggregate components within an operating segment that have similar economic characteristics. Our reporting units for purposes of assessing goodwill impairment are the same as our operating segments, which are organized primarily based on geography and include: (a) North America Plasma, (b) Americas Blood Center and Hospital, (c) Europe, Middle East, and Africa (collectively "EMEA"), (d) Asia-Pacific and (e) Japan. The North America Plasma reporting unit is a separate operating segment with dedicated segment management due the size and scale of the plasma business.
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When allocating goodwill from business combinations to our reporting units, we assign goodwill to the reporting units that we expect to benefit from the respective business combination at the time of acquisition. In addition, for purposes of performing our goodwill impairment tests, assets and liabilities, including corporate assets, which relate to a reporting unit’s operations, and would be considered in determining its fair value, are allocated to the individual reporting units. We allocate assets and liabilities not directly related to a specific reporting unit, but from which the reporting unit benefits, based primarily on the respective revenue contribution of each reporting unit.
In fiscal 2016, we used the income approach, specifically the discounted cash flow method, to derive the fair value of each of our reporting units in preparing our goodwill impairment assessments. This approach calculates fair value by estimating the after-tax cash flows attributable to a reporting unit and then discounting these after-tax cash flows to a present value using a risk-adjusted discount rate. We selected this method as being the most meaningful in preparing our goodwill assessments because the use of the income approach typically generates a more precise measurement of fair value than the market approach. Due to the increased adverse business conditions impacting multiple Haemonetics reporting units in fiscal 2016, w