10-K 1 a06-13357_110k.htm ANNUAL REPORT PURSUANT TO SECTION 13 AND 15(D)

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 1, 2006.

 

Commission file number 1-10730

 

HAEMONETICS CORPORATION
(Exact name of registrant as specified in its charter)

Massachusetts

 

04-2882273

(State of Incorporation)

 

(I.R.S. Employer Identification No.)

 

 

 

400 Wood Road

 

 

Braintree, Massachusetts

 

02184-9114

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (781) 848-7100


Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Name of each exchange

 

 

on which registered

Common stock, $.01 par value

 

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 x   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 x   No o

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes x   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. x

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.

Large accelerated filer x                           Accelerated filer o                              Non-accelerated filer o

Indicate by check mark whether the registrant is a shell company.    Yes o   No x

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 October 1, 2005, the last business day of the registrant’s most recently completed second fiscal quarter was $1,235,000,000 (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 the registrant’s common stock, $.01 par value, outstanding as of May 15, 2006 was 26,894,591

Documents Incorporated By Reference

Portions of the Company’s Proxy Statement for the Annual Meeting of Shareholders to be held on August 9, 2006, are incorporated by reference in Part III.

 




TABLE OF CONTENTS

 

 

 

Page Number

Item 1

 

Business

 

4

 

 

(A) General History of the Business

 

4

 

 

(B) Financial Information about Industry Segments

 

5

 

 

(C) Narrative Description of the Business

 

6

 

 

(D) Financial Information about Foreign and Domestic Operations and Export Sales

 

16

Item 1A

 

Risk Factors

 

17

Item 1B.

 

Unresolved Staff Comments

 

18

Item 2.

 

Properties

 

18

Item 3.

 

Legal Proceedings

 

19

Item 4.

 

Submission of Matters to a Vote of Security Holders

 

20

Item 5.

 

Market For The Registrant’s Common Equity, RELATED Stockholder Matters and issuer purchases of equity securities

 

23

Item 6.

 

Selected Consolidated Financial Data

 

24

Item 7.

 

Management’s Discussion and Analysis of Financial Condition and Results Of Operations

 

26

Item 7a.

 

Quantitative and Qualitative Disclosures about Market risk

 

48

Item 8

 

Financial Statements and Supplementary Data

 

50

Item 9.

 

Changes in and disagreements with accountants on accounting and financial disclosure

 

83

Item 9a.

 

Controls and procedures

 

83

Item 9b.

 

Other information

 

86

Item 10.

 

Directors and executive officers of the registrant

 

87

Item 11.

 

Executive compensation

 

87

Item 12.

 

Security ownership of certain beneficial owners and management and related stockholder matters 

 

87

Item 13.

 

Certain relationships and related transactions

 

88

Item 14.

 

Principal accountant fees and services

 

88

Item 15.

 

Exhibits and financial statement schedules.

 

89

 

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Item 1.                          Business

(A) General History of the Business

Our Company was founded in 1971 and became publicly owned for the first time in 1979. In 1983, American Hospital Supply Corporation (“AHS”) acquired us. When Baxter Travenol Laboratories, Inc. acquired AHS in 1985, Baxter divested the Haemonetics business to address antitrust concerns related to the AHS acquisition. As a result, in December 1985, a group of investors that included E. I. du Pont de Nemours and Company (“Du Pont”) and present and former Haemonetics employees purchased us. We were incorporated in Massachusetts in 1985. In May 1991, we completed an Initial Public Offering at which time Du Pont divested its interest.

We are a pioneer and a market leader in developing and manufacturing technology that helps ensure a safe and adequate blood supply and that assists blood banks and hospitals in their efforts to operate efficiently and in compliance with regulatory requirements. To that end, throughout our history, we have been engaged in manufacturing automated systems and single use consumables used in blood donation, blood processing, and surgical salvage of blood. We also develop associated data management technology.

We developed our first automated blood processing system in 1971 and for more than 30 years we have innovated products and services that improve the safety and practice of transfusion medicine. Our direct customers are blood and plasma collectors, hospitals and hospital service providers.

In fiscal year 2004 we embarked upon two strategies:  1) leveraging the core business to improve profitability and 2) expanding the business through internal R&D, marketing partnerships, and acquisition. As a result of the second strategy, we have broadened our core product portfolio to include complementary products used by our blood collection and hospital customers. In fiscal year 2004, we reorganized into two global product families that address our ultimate customer (our customers’ customer):  blood donors and surgical patients. Within these product families we offer:

Donor Products

1)              Plasma systems:  Our PCS® brand systems automate the collection of plasma from donors who are often paid a fee for their donation. The collected plasma is then generally processed into therapeutic pharmaceuticals.

2)              Blood bank systems:

a)              Our MCS® brand system automates the collection of platelets from volunteer donors. The systems enable the donation of a larger volume of the donor’s platelets, which are then generally given to cancer patients and others with bleeding disorders.

b)             Our ACP® brand systems automate the process used to freeze, thaw and wash red blood cells. The ACP systems can also be used to wash other cellular parts from red blood cells units before transfusion.

c)            We also contract manufacture sterile intravenous solutions for pharmaceutical customers. These solutions include generic and custom drug products.

3)              Red cell systems:  Other MCS systems automate the collection of red cells from volunteer donors. These systems maximize the volume of red cells that can be collected from one blood donation, thus helping to alleviate blood shortages. The highest sales volume product

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in the red cell product line is our double red cell collection technology which allows for two units of red cells to be collected from one donor. Specialty protocols enabling the simultaneous collection of a unit of red cells and a unit of plasma or a unit of red cells and a unit of platelets are also available in various parts of the world.

4)             Data management systems - Our wholly owned subsidiary, 5D Information Management (“5D”) provides data management systems to promote efficient and compliant operations of blood collectors, principally plasma collectors.

Patient Products

1)              Blood salvage:  Our surgical blood salvage systems allow surgeons to collect the blood lost by a patient during or after surgery, clean that blood, and have it available to transfuse back to the patient if needed. In this way, a surgical patient can receive transfusions of the safest blood possible, his or her own. Our surgical blood salvage systems include:

a)              Our Cell Saver® brand systems for higher blood loss surgeries and trauma:

b)             Our OrthoPAT® brand systems for lower, slower blood loss procedures, typically orthopedic surgeries; and

c)              Our cardioPAT™ brand system for blood loss during and after beating heart surgeries or for blood loss after various coronary artery bypass graft (“CABG”) surgeries. The cardioPAT is our newest blood salvage system launched late in fiscal 2006.

2)              Surgical suction:  Our SmartSuction HARMONY™ system clears blood and debris from the surgical field. The system can be used with any of Haemonetics’ surgical blood salvage systems. It was launched in late fiscal 2006.

Our principal operations are in the United States, Europe, and Japan and other parts of Asia. Our products are marketed in more than 50 countries around the world via a direct sales force as well as some independent distributors and agents.

In fiscal year 2006, we remained focused on increasing sales of our red cell collection technology and orthopedic surgical blood salvage system. In addition, we executed to our plan to supply plasma collection systems to one of the world’s largest plasma collectors. We implemented phase 1 of this plan in the first quarter of fiscal 2006 and phase 2 in the fourth quarter of fiscal 2006. In all, we placed 2,900 additional plasma collection systems in the U.S., Finally, we focused resources on introducing four new products by fiscal 2006 year end, and we prepared for the introduction of another three new products in fiscal year 2007.

(B) Financial Information about Industry Segments

Although we address our customer constituents through two global product families (Donor and Patient), we manage our business as one operating segment:  automated blood processing systems. Our chief operating decision maker uses consolidated financial results to make operating and strategic decisions. Manufacturing processes, as well as the regulatory environment in which we operate, are largely the same for all product lines.

The financial information required for the business segment is included herein in Note 16 of the financial statements, entitled SEGMENT, GEOGRAPHIC AND CUSTOMER INFORMATION.

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(C)   Narrative Description of the Business

(i)            Products

We develop and market a variety of automated systems for blood donors and patients world wide that collect, process, and surgically salvage their blood. We also market data management systems through our subsidiary, 5D Information Management (“5D”) to promote efficient and compliant operations of blood collectors, principally plasma collectors.

All of our blood systems involve the extracorporeal processing of human blood, which is made up of components including red blood cells, plasma, platelets, and white blood cells. Doctors today generally treat patients with a transfusion of only the blood component needed, rather than with whole blood. The different components have different clinical applications. For example, plasma derived products treat a variety of  illnesses and hereditary disorders such as hemophilia; red cells treat trauma patients or patients undergoing major surgeries involving high blood loss such as open heart surgery or organ transplant and platelets treat cancer patients undergoing chemotherapy.

With our automated blood collection systems, a blood donation can be targeted to the specific blood component needed by a blood collector. More of that blood component can be collected during any one donation event because the blood components not targeted are returned to the donor through a sterile, closed-circuit disposable set used for the blood donation procedure.

With our automated blood processing systems, blood collectors and hospitals can freeze and thaw red cells so that they can maintain a frozen blood reserve. Blood reserves are often maintained to enable the blood provider to respond adequately to large-scale emergencies where many people require blood transfusions or to treat patients who require transfusions of very rare blood types. Our blood processing systems can also remove plasma from red cells for patients who need specially treated blood.

With our surgical blood salvage systems, medical teams can collect blood lost by a surgical patient during or after the surgery, clean it, and make it available for transfusion back to the patient. These systems ensure that elective surgery will not be cancelled due to lack of available blood, and that a patient receives the safest blood possible — his or her own.

In every one of our major product offerings:  plasma collection, platelet collection, red cell collection, cell processing and surgical cell salvage, we invented the technology that first created the market. We continue to innovate our product offerings with next generation technologies.

Automated Plasma Collection

Automated plasma collection technology allows for the safe and efficient collection of plasma from donors who are usually paid a fee for their blood donation. The plasma which is collected is then further processed (“fractionated”) by pharmaceutical companies into therapeutic and diagnostic products that aid in the treatment of:  immune diseases, inherited coagulation disorders (e.g., hemophilia) and blood volume loss (e.g. from trauma). The collected plasma is also used in the manufacture of vaccines and blood testing and quality control reagents. Our role in the plasma industry is limited to the supply of plasma collection and data management systems to plasma collectors. Our business does not include the actual collection, fractionation, or distribution of plasma-derived pharmaceuticals, businesses mostly conducted by large multi-national pharmaceutical corporations.

Until automated plasma collection technology was pioneered and introduced by our Company in the 1980s, plasma for fractionation was collected manually. Manual collection was time-

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consuming, labor-intensive, produced relatively poor yields, and posed risk to donors. Currently the vast majority of plasma collections worldwide are performed using automated collection technology because it is safe and cost-effective. We market our PCS®2 automated plasma collection systems to commercial plasma collectors as well as not-for-profit blood banks and government affiliated plasma collectors worldwide.

We offer “one stop shopping” to our plasma collection customers, enabling them to source from us the full range of products necessary for their plasma collection operations. To that end, in addition to providing plasma collection equipment and disposables, we offer plasma collection containers, intravenous solutions necessary for plasma collection and storage, and data management technology to automate plasma collectors’ operations (see 5D Data Management Systems).

Blood Bank Systems

The Blood Collection Market for Transfusion

There are millions of blood donations throughout the world every year to obtain blood products for transfusion to surgical, trauma, or chronically ill patients. In the U.S. alone approximately 14 million units of blood are collected each year.

Patients requiring blood are rarely transfused with whole blood. Instead, a patient typically receives only the blood component necessary to treat their clinical condition:  red cells to surgical or trauma patients, platelets to surgical or cancer patients, and plasma to surgical patients.

Worldwide demand for blood continues to rise as the population ages and more patients have need for and access to medical therapies that require blood transfusions. At the same time, tighter donor eligibility requirements to improve blood safety have decreased the number of donors willing or able to donate blood. Thus, this worldwide market is growing modestly in the low single digits.

Most donations worldwide are non-automated procedures (also referred to as “manual or whole blood donations”). In a manual donation, a person donates about a pint of whole blood, bleeding by gravity directly into a blood collection bag. After the donation, a laboratory worker manually processes the blood and separates it into its constituent parts:  red cells, platelets and plasma. One pint of whole blood contains one transfusible dose of red cells, one-half to one transfusible dose of plasma, and one-fifth to one-eighth transfusible dose of platelets.

We do not sell whole blood collection disposables for the large, non-automated part of the blood collection market for transfusions. Others supply this market with whole blood collection supplies such as needles, plastic blood bags, solutions and tubing.

In contrast to manual collections, automated procedures eliminate the need to manually separate whole blood at a remote laboratory. Instead, the blood separation process is automated and occurs “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. Among other things, automated blood collection allows significantly more of the targeted blood component to be collected during a donation event.

Today in the U.S., automated collection systems are used annually to collect more than 550,000 red cell units and about 1.5 million platelet units (called “single donor” platelets.)  One donation from a single donor can produce enough platelets for a transfusible dose as compared to a pooled platelet that combines platelet fractions from 5-8 different whole blood donors).

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Our products address the small part of the blood collection market that uses automation to enhance blood collection safety and efficiency, as well as regulatory compliance. Though we compete against large companies including Baxter International and Gambro BCT, we are the only independent U.S.A. publicly traded company whose business is predominantly focused on automated blood collection.

Automated Platelet Collection Systems

Automated platelet collection systems collect one or more therapeutic “doses” of platelets during a single donation by a volunteer blood donor. Platelets derived from non-automated donations of whole blood (also called manual collections) must be “pooled” together with platelets from 4 to 7 other manual donations to make a single therapeutically useful dose because platelets are only a very small portion of whole blood volume. We invented the automation of platelet collection, resulting in improved platelet yields and improved patient safety.

Platelet therapy is frequently used to alleviate the effects of bone marrow suppression, a condition in which bone marrow is unable to produce a sufficient quantity of platelets. Bone marrow suppression is most commonly a side effect of chemotherapy. Doctors who prescribe platelet therapy increasingly turn to “single donor” platelet products (i.e., enough platelets collected from one donor, during an automated collection, to constitute a transfusible dose) to minimize a patient’s exposure to multiple donors and possible blood-borne diseases.

Related Products that Improve Safety of Platelets

Bacterial Detection

Over the past two years, bacterial detection of platelets has become an emerging trend in the transfusion industry. To reduce risks to patients receiving transfusions, the U.S. has implemented requirements that all platelets be tested for bacteria and several European blood collection agencies are evaluating bacterial screening. Bacterial contamination is one of the most common causes of transfusion-related death, but it also has other risks which can result in longer hospitalization. In February 2004, we reached an agreement with Hemosystem SA to market its bacterial screening technology, Scansystem® in Europe, the Middle East, Africa, and Latin America for the next three years. As part of the agreement, we also assumed right of first refusal to market the product in major Asian countries. Local European evaluations of Scansystem are ongoing.

Pathogen Reduction

Pathogen reduction technologies are processes to eliminate or reduce pathogens, including viruses and bacteria, from blood prior to its transfusion to patients. Pathogen reduction has been discussed by the transfusion community for many years, and is in various stages of development and/or commercialization by several companies, not including Haemonetics. In December 2001 we entered into an agreement with Baxter International, Inc. (“Baxter”) to enable us to seamlessly integrate our platelet collection systems with Baxter’s INTERSOL® which is a platelet storage solution for use with its INTERCEPT® Platelet System for pathogen reduction of platelets. Though some progress was made between 2001 and 2006 in establishing a market for pathogen reduction, in 2006 pathogen reduction of platelets is not routinely practiced in most countries. In February 2006, Baxter announced that it had entered a definitive agreement with Cerus Corporation for Cerus to obtain Baxter’s commercial rights to the INTERCEPT Blood system for platelets worldwide, except in certain Asian countries in which rights had previously been granted by Baxter to BioOne Corporation. Thus, Baxter announced its planned exiting of the business of pathogen inactivation. The Haemonetics Baxter agreement is currently the subject of an arbitration proceeding between the Company

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and Baxter to determine the rights and obligations of the parties to that agreement.  (Note:  INTERSOL and INTERCEPT are registered trademarks of Baxter.)

Intravenous Solutions

During an automated blood donation, intravenous solutions and other solutions are used. We manufacture some of these solutions in our facility in Union, South Carolina. This facility also contract manufactures certain other solutions.

Automated Blood Cell Processing Systems

Our cell processing business is based on technology that enables users to add and remove solutions or other substances to and from blood components. We have several technologies that support this business.

The most significant technology allows the freezing and thawing of blood to enable blood banks to better manage their red cell inventory. Although it has been possible for many years to freeze red cells for up to ten years, the freezing and thawing processes took place in a manual, open-circuit system, which exposed red cells to the potential for bacterial contamination. Once the cells were thawed, they had to be transfused within 24 hours or discarded. The Company’s ACP215 automated cell processing system extends thawed cells’ shelf life to 14 days by performing the freezing and thawing processes in an automated, closed-circuit system.

Automated Red Cell Collection Systems

See the section above entitled “Blood Bank Systems:  Blood Collection for Transfusion” to learn about the market for our red cell collection systems.

Automated red cell collection, a market we created, allows for the safe, efficient collection of more red cells from a single blood donor than from manual, whole blood collections. Most red cells are derived from manual collection of whole blood, after which the components are separated. This manual procedure involves time-consuming, error-prone secondary handling and processing in a laboratory that tax a blood collector’s limited resources. Red cell shortages are a common problem plaguing many healthcare systems worldwide, particularly the U.S.

Our MCS brand systems help blood collectors address their operational challenges. The system automates the blood separation function, eliminating the need for laboratory processing and enables the collection of two transfusible doses of red cells from a single donor thus alleviating blood shortages. We call this our two unit protocol or double red cell collection.

In addition to the two unit protocol, blood collectors can use the MCS brand system to collect either 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 or they may leukoreduce the two unit red cell collections.  Leukoreduction is the removal of potentially harmful white blood cells from the blood. Leukoreduction has been adopted in many countries worldwide, and an estimated 80% of all red cells in the U.S. are now leukoreduced.

During fiscal year 2006, blood shortages continued and blood banks continued their adoption of double red cell collection. The American Red Cross, the largest collector of blood in the U.S., expanded its automated red cell program to include our leukoreduction red cell collection system. Currently approximately 6% of red cells collected in the U.S. are collected on our technology.

Since fiscal 2003, we have directed research and development resources to our next generation system, called the Cymbal™ device (formerly known as the Red Cell Collector). The Cymbal

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system is an automated device to collect and process two units of red cells from donors which is smaller, lighter and more portable than our current red cell collection technology. We continued to advance the Cymbal system in fiscal year 2006 and received CE marking in February 2006. The system is currently in limited market release in a few European countries.

See the section entitled “Research and Development” for further discussion.

5D Data Management Systems

Data management is supplied through our subsidiary, 5D, a leading provider of information management products and services for plasma collectors and fractionators. 5D’s sales are recorded in the miscellaneous and service revenue line, with much of its sales currently to plasma collectors. Our strategy is to expand 5D’s sales to not-for-profit blood collectors. We made initial headway into this strategy in late fiscal year 2005 with an agreement to support the U.S. Department of Defense’s Blood Management Software System.

Surgical Blood Salvage Systems

Surgical blood salvage, also known as autotransfusion, involves the collection of a patient’s own blood during and after surgery, for reinfusion to that patient. In surgical blood salvage, blood is suctioned from a wound site, collected in a centrifuge, and cleaned and filtered to remove unwanted substances from the recovered blood. The blood is transferred to a collection bag and made available for transfusion back to the patient. This process occurs in a sterile, closed-circuit consumable set which sits inside our device. We market our surgical blood salvage products to hospital-based medical specialists, primarily cardiovascular, orthopedic, and trauma surgeons or to surgical suite service providers.

Loss of blood is common in 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. Prior to the introduction of our technology, patients were transfused exclusively with blood from volunteer donors. Donor blood carries various potential risks including (i) risk of transfusion with the wrong blood type (the most common cause of transfusion-related death), (ii) risk of transfusion reactions including death, but more commonly chills, fevers or other side effects that can prolong a patient’s recovery, and (iii) risk of transfusion of blood with a blood-borne disease or infectious agent.

As a result of numerous blood safety initiatives, today’s blood transfusions are extremely safe, especially in developed and resourced health care systems. However, transfusions are not risk free. Surgical blood salvage reduces or eliminates a patient’s dependence on blood donated from others and ensures that the patient receives the safest blood possible — his or her own.

Surgical blood salvage is also a cost effective alternative to transfusing donor blood. Blood shortages have also reinforced the benefits of surgical blood salvage. As hospitals are forced to consider canceling elective surgeries due to unavailability of blood, they can turn to surgical blood salvage as a means of conserving their blood supply for other patients.

We pioneered the first surgical blood salvage systems. Today, we market the Cell Saver® brand system which is targeted to procedures that involve rapid, high volume blood loss such as cardiovascular surgeries, as well as the OrthoPAT® system which is targeted to orthopedic procedures that involve slower, lower volume blood loss that often occurs well after surgery. We are currently in the early stages of introducing the cardioPATTM system for use in open heart surgeries when there is less blood loss.

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In fiscal 2005, we purchased a line of surgical products from Harvest Technologies Corporation. Leveraging our core competency in manufacturing process control, we are reworking these products to our quality specifications. Two products are in late stage development, but the first product resulting from the acquisition, the SmartSuction HARMONYTM system, was launched in late fiscal 2006. The suction system, which is an alternative to wall suction, removes blood and debris from the surgical field before the blood is processed in one of our surgical blood salvage systems.

Recent Events

On June 6, 2006, we entered into a definitive agreement to acquire the outstanding shares of Arryx that we do not already own for $26 million in cash. We plan to account for the acquisition as a business combination. We expect the purchase price premium to be allocated to completed technology and in-process research and development.

(ii)   Revenue Detail

We discuss our revenues using the following categories:

·                  Disposables (the consumables used in blood collecting, processing, and salvaging and fees for the use of our equipment)

·                  Equipment (the sale of devices)

·                  Miscellaneous and Service (including 5D software systems and service contracts)

In fiscal year 2006, sales of disposable products accounted for approximately 87.4% of net revenues. Sales of our disposable products were 7.0% higher in 2006 than in 2005 and grew at a compound average annual growth rate of 7.1% for the three years ended April 1, 2006. The favorable effects of foreign exchange contributed 0.6% of the 7.0% increase in net sales during fiscal year 2006 with the remaining 6.4% increase resulting from increases in disposable revenues across our plasma, red cell, blood bank and surgical product lines due to unit increases and product mix shifts. Sales of equipment accounted for approximately 6.1% of net revenues in fiscal year 2006 and approximately 5.4% in fiscal year 2005. The increase in equipment revenue during fiscal year 2006 is attributable to our surgical, cell processing and plasma product lines.

Service and other miscellaneous revenues accounted for approximately 6.5% and 5.3% of net revenues in fiscal year 2006 and 2005, respectively. The increase during fiscal year 2006 was largely due to software revenue growth from 5D. The increases in 5D sales were principally the result of a software support contract for a United States military customer.

(iii)   Marketing/Sales/Distribution

We market and sell our products to hospitals and hospital service providers, blood systems and independent blood banks, commercial plasma collection centers, 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.

In fiscal year 2006, for the sixth consecutive year, we received the Omega NorthFace ScoreBoard Award for exemplary service to customers. This award is presented to the highest-ranked organizations based on customer ratings of performance against customer expectations in areas such as phone support, on-site operations, technical services, and training.

(iv)   United States

In fiscal year 2006, approximately 38.5% of consolidated net sales were generated in the U.S. where we use a direct sales force to sell our products. (Note:  In August 2005, we ended our exclusive distribution agreement with Zimmer Holdings Inc. for the sale and marketing of the OrthoPAT system within the U.S. As per our contract, Zimmer continued to sell the OrthoPAT system, while Haemonetics simultaneously sold direct, through February 2006.)

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(v)   Outside the United States

In fiscal year 2006, approximately 61.5% of consolidated net revenues were generated through sales to non-U.S. customers. Our direct sales force in Europe and Asia includes full-time sales representatives and clinical specialists based in the United Kingdom, Germany, France, Sweden, the Netherlands, Italy, Austria, Hong Kong, Canada, Japan, Switzerland, Czech Republic, China, Taiwan, and Belgium. We also use various distributors to market our products in South America, the Middle East, and parts of Europe and the Far East.

(vi)   Research and Development

We operate research and development (“R&D”) centers in Switzerland, Japan, and the United States, so that protocol variations are incorporated to closely match local customer requirements. In addition to the above R&D facilities, our 5D subsidiary maintains development operations in Edmonton, Alberta, Canada.

Customer collaboration is also an important part of our technical strength and competitive advantage. We have built consulting relationships with a significant number of transfusion experts around the world. These individuals 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 extracorporeal blood processing systems has required us to maintain technical expertise in various engineering disciplines, including mechanical, electrical, software, biomedical, and materials. 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.

Our expenditures for R&D were $26.5 million for fiscal year 2006 (6.3% of sales), $20.0 million for fiscal year 2005 (5.2% of sales) and $17.4 million (4.8% of sales) for fiscal year 2004. All R&D costs are expensed as incurred. We expect to continue to invest resources in R&D.

In fiscal year 2006, R&D resources were allocated to completing work on a new surgical blood salvage device, the cardioPAT, the CymbalTM (formerly Red Cell Collector), two blood collection software systems (E*Interview and HaemoConnect), and our next generation Donor apheresis platform, as well as several projects to enhance our current product portfolio. The cardioPAT surgical blood salvage system is a small, portable, and operator-friendly surgical blood salvage device designed to address lower volume blood loss during and after open heart surgery. This device entered limited market release in early fiscal year 2006.

(vii)    Manufacturing

Our principal manufacturing operations (equipment, disposables, and solutions) are located in Braintree, Massachusetts; Leetsdale, Pennsylvania; Union, South Carolina; and Bothwell, Scotland.

In general, our production activities occur in a controlled setting or “cleanroom” environment. 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.

Some component manufacturing is performed by outside contractors according to our specifications. We maintain important relationships with two Japanese manufacturers that

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provide finished consumables in Singapore, Japan, and Thailand. Certain parts and components are purchased from various single sources. If necessary, we believe that, in most cases, alternative sources of supply could be identified and developed within a relatively short period of time. Nevertheless, an interruption in supply could temporarily interfere with production schedules and affect our operations. All of 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.

Each blood processing machine is designed in-house and assembled from components that are either manufactured by us or by others 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. During fiscal 2006, we manufactured approximately 90% of our equipment. The remainder was manufactured for us by outside contractors.

We have established a Customer Oriented Redesign for Excellence (“CORE”) program, which is based on the tenets of Total Quality of Management (“TQM”) and using Six Sigma Statistic methods. This program’s goals include:  1) improving customer satisfaction through top quality and on-time deliveries, 2) lowering production costs, and 3) optimizing inventories.

(viii)   Intellectual Property

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 or may be defensive in that they are directed to technologies not yet embodied in our current products. We also license patent rights from third parties that cover technologies that we use or plan to use in our business. We consider our patent rights to be important to 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 international 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 vary widely. We cannot assure that pending patent and trademark applications will result in issued patents and trademarks, that patents issued to or licensed by us will not be challenged or circumvented by competitors, or that our patents will not be found to be invalid.

(ix)   Competition

We created our markets and have established a record of innovation and market leadership in each of the areas in which we compete. Although we compete directly with others, no one company competes with us across our full line of products.

To remain competitive, we must continue to develop and acquire cost-effective new products, technologies and services. We believe that our ability to maintain a competitive advantage will continue to depend on a combination of factors, including factors within our control (reputation, regulatory approvals, patents, unpatented proprietary know-how in several technological areas,

13




product quality, safety and cost effectiveness and continual and rigorous documentation of clinical performance) as well as factors outside of our control (regulatory standards, medical standards and the practice of medicine).

In the automated plasma collection markets, we compete with Baxter International, Inc. on the basis of quality, ease of use, services and technical features of systems, and on the long-term cost-effectiveness of equipment and disposables. To a much lesser degree, our automated systems also compete with manual collection systems, which are less expensive, but are also slower, less efficient, and clinically riskier. Baxter had pursued a strategy of developing plasma collection sites and acquiring collection centers, which altered the competitive landscape and affected our past sales. In October 2003, Baxter acquired our largest U.S. plasma customer, Alpha Therapeutic Corporation (“Alpha”). Upon Baxter’s announcement of its acquisition of Alpha’s business, Baxter closed 38 of 41 of the former Alpha centers and sold the remaining three centers.   These center closures significantly and negatively affected our plasma sales in fiscal 2004 and 2005. (See Legal Proceedings section for more information.)

In the automated platelet collection markets, competition is based on continual performance improvement, as measured by the time and efficiency of platelet collection and the quality of the platelets collected. Our product quality is exceptional, as evidenced by more than 70% market share in Japan, where quality is a leading purchasing consideration. Our major competitors in the automated platelet collection market are Gambro BCT and Baxter. Each of these companies has taken a different technological approach in designing their systems for the automated platelet collection market. In the platelet collection market, we also compete with whole blood collections from which pooled platelets are derived.

In the cell processing market, competition is based on level of automation, labor-intensiveness, and system type (open versus closed). Open systems may be weaker in GMP compliance. Moreover, blood processed through open systems has a 24 hour shelf life. We do have open system cell processors which compete with Gambro BCT systems. However, our closed system cell processor’ which gives blood processed through it a 14 day shelf life, has no competition.

Our automated red cell collection systems were pioneered in the late 1990s. We preceded one competitor, Gambro BCT to market by 2 years, and the other competitor, Baxter, to market by six years. However, it is important to note that less than 1% of the forty million red cells collected worldwide and about 8% of the fifteen million red cells collected in the U.S. annually are collected via automation today by these three companies combined. So, we more often compete with traditional (manual / whole blood) methods of deriving red cells by collecting and separating a pint of whole blood on the basis of total cost, process control, product quality, and inventory management.

In the high blood loss surgical blood salvage market, competition is based on reliability, ease of use, service, support, and price. Each manufacturer’s technology is similar, and we compete principally with Medtronic, Fresenius, and Sorin Biomedica.

In the orthopedic surgical blood salvage market we have no direct competitors. The OrthoPAT system is the only system designed specifically for use in orthopedic surgeries where a patient often bleeds more slowly, bleeds less, and bleeds well after surgery.

Our technical staff is highly skilled, but many competitors have substantially greater financial resources and larger technical staffs 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.

14




(x)   Seasonality

Net revenues have historically been higher in the second half of our fiscal year, reflecting principally the seasonal buying patterns of our customers. This has proven true in four of our last five fiscal years with the exception of fiscal year 2003 where the second half of our fiscal year had slightly lower revenues due principally to market conditions in plasma.

(xi)   Government Regulation

The products we manufacture and market are subject to regulation by the Center of Biologics Evaluation and Research (“CBER”) and the Center of Devices and Radiological Health (“CDRH”) 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 Pre-market 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 FDA to be medical devices, subject to 510(k) pre-market notification. Intravenous (“IV”) solutions marketed by us for use with our automated systems (blood anticoagulants and solutions for storage of red blood cells) require us to obtain from CBER an approved New Drug Application (“NDA”) or Abbreviated New Drug Application (“ANDA”). A 510(k) pre-market clearance indicates 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 take up to 24 months and involves the submission of clinical data and supporting information. The process of obtaining NDA approval for solutions is likely to take much longer than 510(k) approvals because the FDA review process is more complicated.

We maintain customer complaint files, record all lot numbers of disposable products, and conduct periodic audits to assure compliance with FDA regulations. We place special emphasis on customer training and advise all customers that blood processing procedures should be undertaken only by qualified personnel.

We are also subject to regulation in the countries outside the United States in which we market our products. Many of the regulations applicable to our products in such countries are similar to those of the FDA. However, the national health or social security organizations of certain countries require our products to be qualified by those countries before they can be marketed in those countries. We have complied with these regulations and have obtained such qualifications.

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.

(xii)   Environmental Matters

We do not anticipate that compliance with federal, state, and local environmental protection laws presently in effect will have a material adverse impact upon our business or will require any material capital expenditures. However, environmental laws, including those that regulate raw materials for medical grade plastics, are subject to change. We cannot predict what impact, if any, such changes might have on our business.

15




(xiii)   Employees

As of April 1, 2006, we employed 1,661 persons assigned to the following functional areas:  manufacturing, 819; sales and marketing, 304; general and administrative, 203; research and development, 127; and quality control and field service, 208. We consider our employee relations to be satisfactory.

(xiv)   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://www.haemonetics.com/site/content/investor/corp_gov.asp. Such information is also available in print to any shareholder who requests it. All requests should be directed to our Company’s Secretary. 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 as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

(D) Financial Information about Foreign and Domestic Operations and Export Sales

The financial information required by this item is included herein in Note 16 of the financial statements, entitled Segment, Geographic and Customer Information. Sales to the Japanese Red Cross accounted for 18.0% of net revenues in fiscal year 2006. No other customer accounted for more than 10% of our net revenues. For more information concerning significant customers, see subheading of Note 2 of the financial statements, entitled, Concentration of Credit Risk and Significant Customers.

Cautionary Statement

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 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. Such risks and uncertainties include technological advances in the medical field and our standards for transfusion medicine and our ability to successfully implement products that incorporate such advances and standards, product demand and market acceptance of our products, regulatory uncertainties, the effect of economic and political conditions, the impact of competitive products and pricing, foreign currency exchange rates, changes in customers’ ordering patterns, the effect of industry consolidation especially as seen in the Plasma market, the effect of communicable diseases and the effect of uncertainties in markets outside the U.S. (including Europe and Asia) in which we operate. The foregoing list should not be construed as exhaustive.

16




 

Item 1A.   Risk Factors

Set forth below are the risks that we believe are material to our investors. This section contains forward-looking statements. You should refer to the explanation of the qualifications and limitations on forward-looking statements beginning on page 47.

Our inability to successfully expand the business, through internal research and development, marketing partnerships and acquisitions, could have a material adverse effect on our business.  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 that we invest significant resources. We may not be able to integrate any acquired businesses successfully into our existing business, make such businesses profitable, or realize anticipated market growth or cost savings.

If we are unable to successfully keep pace with technological advances in the medical field and the standards for transfusion medicine, our business, financial condition and results of operation could be adversely affected. The success of our products will depend upon our ability to anticipate and meet the needs of the medical field, particularly those who practice transfusion medicine. Additionally, we must be able to manufacture the products in a cost effective manner, with high quality and obtain permission to market and sell the products from various regulatory authorities.

As a medical device manufacturer we are subject to a number of existing 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. Some regulatory authorities outside the United States may have a bias in favor of locally produced goods that could delay or prevent our achieving regulatory approval to market our products in such geographies. We must obtain specific regulatory clearance prior to selling any new product or service, and our operations are also subject to continuous review and monitoring by the FDA and other regulatory authorities. The process of obtaining approval to market and distribute our products is costly and time-consuming. Export of U.S. technology or goods manufactured in the United States to some jurisdictions requires special U.S. export authorization that may be influenced by factors, including political dynamics, outside our control. Changes in privacy regulations and other developments in human subjects’ clinical trials could make it more difficult and more expensive to conduct clinical trials necessary for product approval. Regulations about the use of certain materials in the manufacture of health care products could also require us to identify alternate material(s), which may be at higher costs. The number of eligible blood donors is influenced by government regulations (including travel restrictions, health history, etc.) and other economic and sociological factors. Changes in donation related regulations could have significant immediate effects on the population of eligible donors.

We are subject to various actions by government authorities that regulate medical devices including: product recalls, orders to cease manufacturing or distribution activities, and other sanctions or penalties. Compliance with these regulations is costly and additional regulation could adversely affect our results of operations. Our customers are also subject to these regulations. Our customers’ compliance with applicable regulations could also affect our results of operations.

17




 

Many of our competitors have significantly greater financial and other resources. Their greater financial resources may allow them to more rapidly develop new technologies, and more quickly address changes in customer requirements. Although no one company competes with us across our full line of products, we face competition in each of our product lines. Our ability to remain competitive depends on a combination of factors, including those within our control (reputation, regulatory approvals, patents, unpatented proprietary know-how in several technological areas, product quality, safety, cost effectiveness and continued rigorous documentation of clinical performance) as well as factors outside of our control (regulatory standards, medical standards and the practice of medicine). Also, sales of unauthorized copies of our products by local competitors in China could affect the demand and price paid for our products.

As a multinational corporation, we are exposed to fluctuations in currency exchange rates, which could adversely affect our cash flows and results of operations. International revenues account for a substantial portion of our revenues, and we intend to continue expanding our presence in international markets. In 2006, our international revenues accounted for approximately 61% of our total revenues. The exposure to fluctuations in currency exchange rates takes different forms. Reported revenues for sales made in foreign currencies by our international businesses, when translated into U.S. dollars for financial reporting purposes, fluctuate due to exchange rate movement. 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 is made in local currencies.

We are subject to the risks of international economic and political conditions.  Our international operations are subject to risks which are inherent in conducting business overseas and under foreign laws, regulations and customs. These risks include possible nationalization, expropriation, importation limitations, violations of U.S. or local laws, pricing restrictions, and other restrictive governmental actions. Any significant changes in the competitive, political, legal, regulatory, reimbursement or economic environment where we conduct international operations may have a material impact 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 HIV, SARS or pandemic bird flu) 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.

Item 1B.   Unresolved Staff Comments

None

Item 2.                          Properties

Our main facility is located on 14 acres in a light industrial park in Braintree, Massachusetts. It was constructed in the 1970s. The building is approximately 180,000 square feet, of which 70,000 square feet are devoted to manufacturing and quality control operations, 35,000 square

18




feet to warehousing, 72,000 square feet for administrative and research and development activities and 3,000 square feet available for expansion. See Note 7 to the financial statements for details of our mortgage on the Braintree facility.

On property adjacent to the main facility, the Company leases 43,708 square feet of additional office space. This facility is used for sales, marketing, finance and other administrative services. Annual lease expense for this facility is $635,042.

Near our main facility, in Avon, Massachusetts, we lease a 61,000 square foot facility. This facility is used for warehousing and distribution of products. Annual lease expense for this facility is $390,598.

We lease an 81,850 square foot facility in Leetsdale, Pennsylvania. This facility is used for warehousing, distribution and manufacturing operations. Annual lease expense is $311,330 for this facility.

We own a facility in Union, South Carolina. This facility is used for the manufacture of sterile solutions to support our blood bank (component therapy) and plasma businesses. Additionally, this facility is engaged in contract manufacturing of other sterile solutions for veterinary and pharmaceutical customers. The facility is approximately 69,300 square feet.

We own a facility in Bothwell, Scotland used to manufacture disposable components for European customers. The original facility is approximately 22,200 square feet. An addition of 18,000 square feet was added in early fiscal year 2006. This expansion provided 10,000 square feet of warehouse space replacing space currently leased for this purpose.

We lease 19,095 square feet of office space in Edmonton, Alberta, Canada for 5D Information Management. Annual lease expense is $150,634.

We also lease sales, service, and distribution facilities in Japan, Europe (Austria, Belgium, Czech Republic, France, Germany, Italy, Sweden, Switzerland, the Netherlands, and United Kingdom), China, Hong Kong and Taiwan to support our international business.

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 that any such liability will not materially affect our consolidated financial position or our results of operations.

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. In addition, such litigation could damage our reputation and, therefore, impair our ability to market our products or to obtain professional or product liability insurance or cause the premiums for such insurances to increase. We carry product liability coverage. While we believe that the aggregate current coverage is sufficient, there can be no assurance that such coverage will be adequate to cover liabilities which may be incurred. Moreover, we may in the future be unable to obtain product and professional liability coverage in amounts and on terms that we find acceptable, if at all.

In order to aggressively protect our intellectual property 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 intellectual property, and

19




it is still possible that even patented technologies may not be protected absolutely from infringement.

On January 21, 2004, we filed a claim for binding arbitration against Baxter, seeking an arbitration award to compel Baxter to honor numerous supply contracts it assumed when Baxter purchased the plasma collection operations of Alpha Therapeutic Corporation, our largest plasma customer, or to pay us damages. The matter was tried before an arbitration panel for three weeks ending April 1, 2005. The arbitration panel issued its decision on May 20, 2005 and awarded the Company $30.8 million including damages, legal fees and interest. We collected the full award on October 13, 2005.

In December 2005, we filed a claim for binding arbitration against Baxter, seeking damages as well as an arbitrator’s determination of the rights and obligations of Baxter and Haemonetics, under the Technology Development Agreement between them dated December 2001 concerning platelet pathogen inactivation. (see section on pathogen reduction market at page 8).   Our arbitration claim arises out of Baxter’s decision to exit the pathogen inactivation market. An arbitrator has been selected by the parties but the arbitration hearings have not been scheduled.

In December 2005, we filed a lawsuit against Baxter in the federal district court of Massachusetts, in Boston, seeking an injunction and damages on account of Baxter’s infringement of Haemonetics patent, through the sale of Baxter’s Alyx brand automated red cell collection system which competes with Haemonetics’ automated red cell collection systems. Discovery has not yet begun.

Item 4.                          Submission of Matters to a Vote of Security Holders

Not applicable.

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.

PETER ALLEN joined our Company in 2003 as President, Donor Division. Prior to joining our Company, Mr. Allen was Vice President of The Aethena Group, a private equity firm providing services to the global healthcare industry. From 1998 to 2001, he held various positions including Vice President of Sales and the Oncology Business at Syncor International, a provider of radiopharmaceutical and comprehensive medical imaging services. Previously, he held executive level positions in sales, marketing and operations in DataMedic, Inc., Enterprise Systems, Inc./HBOC, and Robertson Lowstuter, Inc. Mr. Allen has also worked in sales at American Hospital Supply Corporation and Baxter International, Inc.

BRIAN CONCANNON joined our Company in 2003 as President, Patient Division. Prior to joining our Company, Mr. Concannon was President, Northeast Region, Cardinal Health Medical Products and Services. From 1996 to 1999, he was with Allegiance Healthcare, most recently holding the position of Vice President, Distribution Sales and Operations. Mr. Concannon has also held various sales and marketing positions at American Hospital Supply Corporation and Baxter Healthcare Corporation.

20




 

ROBERT EBBELING joined our Company in 1987 as Manager of Injection Molding. Throughout his career at our Company, Mr. Ebbeling has held various management and executive positions in manufacturing and operations. In 1996, he was appointed to Senior Vice President, Manufacturing. In February 2003, Mr. Ebbeling was promoted to Executive Vice President, Manufacturing, and then in August 2003, he was promoted to Vice President, Operations. Prior to joining our Company, Mr. Ebbeling was Vice President, Manufacturing, for Data Packaging Corporation.

DR. ULRICH ECKERT joined our Company in 1995 as Vice President, Haemonetics Germany. In 1998 and 2001, Dr. Eckert assumed additional responsibility for European plasma marketing and our Nordic countries’ subsidiaries respectively. In 2002, he was promoted to President, Europe and Latin America. Prior to joining our Company, Dr. Eckert spent eight years with Apple Computer where his most recent responsibility was Director, Business Systems for Germany, Austria and Switzerland.

ALICIA R. LOPEZ joined our Company in 1988 as General Counsel and Director of Human Resources. Throughout her career at Haemonetics, Ms. Lopez has held various executive positions with responsibilities over legal, human resources, administration, regulatory affairs, and investor relations. Since 1990, she has served as Secretary to the Board of Directors. In 2000, Ms. Lopez was appointed Senior Vice President. In 2003, Ms. Lopez was named Vice President and General Counsel and in 2004 she was promoted to General Counsel and Vice President of Administration. Prior to joining our Company, Ms. Lopez was a litigation associate with the law firm of Sullivan & Worcester.

BRAD NUTTER joined our Company in 2003 as Board Member, President and Chief Executive Officer. Prior to joining our Company, Mr. Nutter was President and Chief Executive Officer of Gambro Healthcare, an international dialysis provider, a division of Gambro AB. From 1997 to 2000, he was Executive Vice President and Chief Operating Officer of Syncor International, an international provider of radiopharmaceuticals and medical imaging. Previously, Mr. Nutter held senior level positions at American Hospital Supply Corporation and Baxter International, Inc.

DR. MARK POPOVSKY joined our Company in 2000 as Senior Vice President and Corporate Medical Director. Prior to joining our Company, he served in the capacity of Chief Medical Officer & Chief Executive Officer at the American Red Cross — New England Region for 15 years. He is currently an Associate Professor of Pathology at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston. Dr. Popovsky received his transfusion medicine training at the National Institutes of Health and Mayo Clinic. At Mayo Clinic he was the Director of Transfusion & Intravenous Services for 3 years. He serves on 7 editorial boards and is the author of more than three hundred peer-reviewed publications in transfusion medicine.

RONALD J. RYAN joined our Company in 1998 as Senior Vice President and Chief Financial Officer. In 2003, Mr. Ryan was named Vice President and Chief Financial Officer. Prior to joining our Company, he held the position of Chief Financial Officer and later Senior Vice President of Operations with Converse Inc. From 1984 to 1990, Mr. Ryan was Vice President of Finance and Business Planning for the Europe, Middle East and Africa Division of Bristol-Myers Squibb.

JOSEPH FORISH joined our Company in 2005 as Vice President, Human Resources. Prior to joining our Company, Mr. Forish held various positions in the human resources area; most recently  as Vice President, Corporate Human Resources for Rohm and Haas Company, an $8 billion global specialty materials company. Prior to that, Mr. Forish was Vice President, Human Resources for the ConvaTec Division of Bristol-Myers Squibb Company.

21




 

WILLIAM STILL joined our Company in 2004 as Vice President of Strategic Marketing and Business Development. Prior to joining our Company, Mr. Still was Senior Director, Business Development for Advanced Respiratory Inc. From 1996 to 2001, he was with St. Jude Medical, most recently holding the position of Senior Associate, Business Development. Mr. Still has also held the position of Finance Manager for St. Jude’s Cardiac Surgery Group.

22




PART II

Item 5.                          Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Our common stock is listed on the New York Stock Exchange under 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 1, 2006:

 

 

 

 

 

 

 

 

 

Market price of Common Stock:

 

 

 

 

 

 

 

 

 

High

 

$

43.97

 

$

48.58

 

$

52.79

 

$

53.62

 

Low

 

$

36.15

 

$

38.58

 

$

44.36

 

$

44.21

 

 

 

 

 

 

 

 

 

 

 

Fiscal year ended April 2, 2005:

 

 

 

 

 

 

 

 

 

Market price of Common Stock:

 

 

 

 

 

 

 

 

 

High

 

$

31.70

 

$

33.25

 

$

37.25

 

$

45.23

 

Low

 

$

24.95

 

$

26.52

 

$

31.50

 

$

34.07

 

 

There were approximately 607 holders of record of the Company’s common stock as of May 15, 2006. 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.

23




Item 6.                          Selected Consolidated Financial Data

Haemonetics Corporation and Subsidiaries Five-Year Review
(in thousands, except share and employee data)

 

 

2006

 

2005

 

2004

 

2003

 

2002

 

Summary of Operations

 

 

 

 

 

 

 

 

 

 

 

Net revenues

 

$

419,733

 

$

383,598

 

$

364,229

 

$

336,956

 

$

319,969

 

Cost of goods sold

 

$

199,198

 

$

185,722

 

$

190,693

 

$

182,260

 

$

165,135

 

Gross profit

 

$

220,535

 

$

197,876

 

$

173,536

 

$

154,696

 

$

154,834

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

26,516

 

$

19,994

 

$

17,398

 

$

19,512

 

$

19,512

 

Selling, general and administrative

 

$

121,351

 

$

118,039

 

$

108,845

 

$

97,705

 

$

88,874

 

Acquired research and development

 

 

 

 

 

$

10,000

 

Arbitration Award Income

 

$

(26,350

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

$

121,517

 

$

138,033

 

$

126,243

 

$

117,217

 

$

118,386

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

$

99,018

 

$

59,843

 

$

47,293

 

$

37,479

 

$

36,448

 

Other income (expense), net

 

$

7,864

 

$

(2

)

$

(1,481

)

$

1,128

 

$

2,057

 

 

 

 

 

 

 

 

 

 

 

 

 

Income before provision for income taxes

 

$

106,882

 

$

59,841

 

$

45,812

 

$

38,607

 

$

38,505

 

Provision for income taxes

 

$

37,806

 

$

20,202

 

$

16,492

 

$

10,228

 

$

10,782

 

 

 

 

 

 

 

 

 

 

 

 

 

Income before cumulative effect of a change in accounting principle

 

$

69,076

 

$

39,639

 

$

29,320

 

$

28,379

 

$

27,723

 

 

 

 

 

 

 

 

 

 

 

 

 

Cumulative effect of a change in accounting principle

 

 

 

 

 

$

2,304

(a)

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

69,076

 

$

39,639

 

$

29,320

 

$

28,379

 

$

30,027

 

 

 

 

 

 

 

 

 

 

 

 

 

Income per share:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

2.61

 

$

1.55

 

$

1.20

 

$

1.15

 

$

1.15

 

Diluted

 

$

2.51

 

$

1.52

 

$

1.19

 

$

1.13

 

$

1.11

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares

 

26,478

 

25,523

 

24,435

 

24,591

 

26,214

 

Common stock equivalents

 

996

 

622

 

260

 

457

 

941

 

Weighted average number of common and common equivalent shares

 

27,474

 

26,145

 

24,695

 

25,048

 

27,155

 


(a)             Effective April 1, 2001, the Company adopted Statement of Financial Accounting Standards (“SFAS”) No. 133, “Accounting for Derivative Instruments and Hedging Activities”, as amended, which resulted in the recognition of $2.3 million as a cumulative effect of a change in accounting principle, net of tax. This amount is the change in the fair value of forward contracts related to forward points, which the Company excludes from its assessment of hedge effectiveness.

24




 

 

 

2006

 

2005

 

2004

 

2003

 

2002

 

Financial and Statistical Data:

 

 

 

 

 

 

 

 

 

 

 

Working capital

 

$

330,288

 

$

255,689

 

$

185,606

 

$

122,880

 

$

148,737

 

 

 

 

 

 

 

 

 

 

 

 

 

Current ratio

 

4.7

 

3.9

 

2.9

 

2.2

 

2.8

 

Property, plant and equipment, net

 

$

75,266

 

$

69,337

 

$

78,030

 

$

83,987

 

$

84,877

 

 

 

 

 

 

 

 

 

 

 

 

 

Capital expenditures

 

$

33,774

 

$

17,530

 

$

13,862

 

$

16,715

 

$

23,509

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

$

25,150

 

$

27,756

 

$

30,149

 

$

28,431

 

$

25,616

 

 

 

 

 

 

 

 

 

 

 

 

 

Total assets

 

$

546,543

 

$

467,757

 

$

407,394

 

$

359,485

 

$

364,921

 

Total debt

 

$

39,153

 

$

45,843

 

$

58,260

 

$

70,617

 

$

72,143

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity

 

$

441,650

 

$

355,135

 

$

279,749

 

$

223,237

 

$

236,824

 

Return on average equity

 

17.34

%

12.50

%

11.70

%

12.30

%

13.30

%

Debt as a   % of stockholders’ equity

 

8.87

%

12.90

%

20.80

%

31.60

%

30.50

%

 

 

 

 

 

 

 

 

 

 

 

 

Employees

 

1,661

 

1,546

 

1,438

 

1,497

 

1,498

 

Net revenues per employee

 

$

254

 

$

248

 

$

253

 

$

225

 

$

214

 

 

 

 

 

 

 

 

 

 

 

 

 

 

25




Item 7.                          Management’s Discussion and Analysis of Financial Condition and Results of Operations

(A)       Our Business

We design, manufacture and market automated systems for the collection, processing and surgical salvage of donor and patient blood, including the single-use disposables used with our systems and related data management software. Our systems allow users to collect and process only the blood component(s) they target, plasma, platelets, or red blood cells, increasing donor and patient safety as well as collection efficiencies. Our systems consist of proprietary disposable sets that operate on our specialized equipment. Our data management systems are used by blood collectors to improve the safety and efficiency of blood collection logistics by eliminating previously manual functions at commercial plasma and not-for-profit blood banks.

We either sell our devices to customers (equipment revenue) or place our devices with customers subject to certain conditions. When the device remains our property, the customer has the right to use it for a period of time as long as they meet certain conditions we have established, which among other things, generally include one or more of the following:

·                  Purchase and consumption of a minimum level of disposable products.

·                  Payment of monthly rental fees.

·                  An asset utilization performance metric, such as performing a minimum level of procedures per month per device.

Our disposable revenue stream (including sales of disposables and fees for the use of our equipment) accounted for approximately 87% of our total revenues for fiscal year 2006 and 89% for fiscal years 2005 and 2004.

(B)       Product Families

Our donor products include systems to collect plasma, platelets and red cells from blood donors. We market our donor products primarily to blood collectors which include both for-profit plasma collectors and not-for-profit blood banks.

Our patient products include systems to collect (during and after surgery), wash and filter unwanted substances from the blood, preparing it for reinfusion to the surgical patient. We market these patient products to hospitals and hospital service providers.

Miscellaneous and service revenue includes revenue generated from equipment repairs performed under preventive maintenance contracts or emergency service billings, as well as revenue from 5D software sales.

Donor Products

Plasma

PCS plasma collection systems — These systems are used by plasma collectors to collect the plasma component of a donor’s whole blood. The plasma is sold to fractionators for processing into therapeutic pharmaceuticals and vaccines. Automated plasma collection is a safe and cost-effective improvement to manual (non-automated) plasma collection which is time-consuming, labor-intensive, produces relatively poor yields, and poses risks to donors. Currently the majority of plasma collections worldwide are automated collections.

26




Blood Bank

MCS platelet collection system — These systems are used by blood collectors to collect the platelet component of a donor’s whole blood. Platelets are transfused to cancer patients whose platelets have been depleted as a result of chemotherapy. Before the advent of our platelet collections technology, the “pooling” or combination of platelets from 5 to 8 different donors was the only alternative to prepare a single therapeutic dose for transfusion to a patient. Our MCS line of products allows the collection of a sufficient number of platelets from only one donor to produce one or two therapeutic doses.

ACP cell processing systems — These systems are used in freezing, thawing and washing of red cells, which enables blood collectors to better manage their red cell inventories. In a liquid state, red cells must be transfused within 42 days whereas frozen red cells may be stored for up to ten years. Previous generation freezing technology required that red cells be transfused within 24 hours after thawing; our ACP 215 system allows red cells to be transfused for up to 14 days post thaw.

Intravenous solutions — We manufacture intravenous and other solutions for use with our blood processing technology. We also contract manufacturing intravenous solutions for pharmaceutical customers. These solutions include generic drugs and other custom drug products.

Red Cell

MCS red cell collection systems — These systems are used to automate the collection of red cells from blood donors with protocols that allow for the collection of two units of red cells, a unit of red cells and a unit of plasma, or a unit of red cells and a unit of platelets. The systems improve the blood collector’s operational efficiency by increasing the volume of blood components collected per donation event and number of red cells than the traditional (non-automated) collection method and helps blood systems address red cell shortages that commonly plague health care systems.

Patient Products

Surgical

Surgical blood salvage systems — These systems are used by hospitals to collect a patient’s own blood during or after surgery for reinfusion to the patient, mitigating or eliminating the need for transfusion of donated blood. We market Cell Saver brand systems for higher blood loss procedures such as cardiovascular surgeries and the OrthoPAT brand system for lower blood loss orthopedic surgeries. The cardioPAT brand system is our newest product, targeted at beating heart and other cardiovascular surgeries that result in bleeding during and after surgery.

27




Financial Summary

 

 

For the years ended

 

% Increase/

 

% Increase/

 

 

 

April 1,

 

April 2,

 

April 3,

 

(Decrease)

 

(Decrease)

 

(in thousands, except per share data)

 

 

 

2006

 

2005

 

2004

 

06 vs. 05

 

05 vs. 04

 

Net revenues

 

$

419,733

 

$

383,598

 

$

364,229

 

9.4

%

5.3

%

Gross profit

 

$

220,535

 

$

197,876

 

$

173,536

 

11.5

%

14.0

%

% of net revenues

 

52.5

%

51.6

%

47.6

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

$

99,018

 

$

59,843

 

$

47,293

 

65.5

%

26.5

%

% of net revenues

 

23.59

%

15.60

%

13.00

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

$

(1,917

)

$

(2,361

)

$

(2,903

)

(18.8

)%

(18.7

)%

Interest income

 

$

6,963

 

$

2,233

 

$

1,848

 

> 100

%

20.8

%

Other income / (expense), net

 

$

2,818

 

$

126

 

$

(426

)

> 100

%

> (100

)%

 

 

 

 

 

 

 

 

 

 

 

 

Income before taxes

 

$

106,882

 

$

59,841

 

$

45,812

 

78.6

%

30.6

%

 

 

 

 

 

 

 

 

 

 

 

 

Provision for income tax

 

$

37,806

 

$

20,202

 

$

16,492

 

87.1

%

22.5

%

% of pre-tax income

 

35.4

%

33.8

%

36.0

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

69,076

 

$

39,639

 

$

29,320

 

74.3

%

35.2

%

% of net revenues

 

16.5

%

10.3

%

8.0

%

 

 

 

 

 

Net revenues for fiscal year 2006 increased 9.4% over fiscal year 2005. The favorable effects of foreign exchange contributed 0.5% of the increase with the remaining 9.0% resulting principally from increases in disposable revenues across our plasma and red cell product lines due to unit increases and product mix shifts. Gross profit increased 11.5% over fiscal year 2005. The favorable effects of foreign exchange accounted for a 3.4% increase in gross profit. The remaining 7.9% increase was due primarily to (i) the increase in sales, (ii) cost reductions, and (iii) a decrease in depreciation on our equipment at customer sites offset by a change in the mix of products being sold. Operating income increased 65.5% over fiscal year 2005. The favorable effects of foreign exchange accounted for a 15.1% increase. The remaining increase of 45.9% resulted as gross profit increases and an arbitration award offset partly by increases in operating expenses.  An arbitration award received from Baxter on October 13, 2005 decreased operating expenses and increased operating income by $26.4 million. Without the favorable effects of foreign currency and the arbitration award, operating income increased 5.8% over 2005 primarily due to increases in gross profit partly offset by increases in operating expenses. The primary contributors to higher expense were (i) new product research and development costs, (ii) expansion of sales and marketing staff to support business growth, (iii) freight costs due to increased volume, and (iv) a $3.8 million impairment charge for the platelet pathogen reduction intangible asset taken in the third quarter of fiscal year 2006, partially offset by a $1.8 million impairment charge taken in the third quarter last year to write down the value of a previously acquired intangible asset.

28




Net income increased 74.3% over fiscal year 2005. The favorable effects of foreign exchange accounted for 14.6% of the increase. The remaining increase of 54.3% was due to the increase in operating income, an increase in other income, net, including interest expense and interest income, partially offset by higher tax expense.

Net revenues for fiscal year 2005 increased 5.3% over fiscal year 2004. The favorable effects of foreign exchange contributed 5.0% of the increase with the remaining 0.3% resulting from increases in disposable revenues across our blood bank, red cell and surgical product lines due to unit increases and product mix shifts. These increases were almost entirely offset by decreases in our plasma product line. Gross profit increased 14.0% over fiscal year 2004. The favorable effects of foreign exchange accounted for 9.8% of the increase in gross profit. The remaining 4.2% increase was due primarily to (i)  the increase in sales, ii) a decrease in depreciation on our equipment at customer sites and (iii) the excess and obsolete inventory provisions recorded in fiscal year 2004 related to the loss of our Alpha business and other matters. Operating income increased 26.5% over fiscal year 2004.  The favorable effects of foreign exchange accounted for 27.8% of the increase. The remaining decrease of 1.3% resulted as gross profit improvements were more than offset by increases in operating expenses.  Net income increased 35.2% over fiscal year 2004. The favorable effects of foreign exchange accounted for 28.9% of the increase. The remaining increase of 6.3% was due to a decrease in other expense, net, including interest expense and interest income, and lower tax expense.

Market Trends

Plasma Market

The continued increase in demand for plasma derived pharmaceuticals, particularly intravenous immunoglobulin (“IVIG”), is a key driver of increased plasma collections in the worldwide commercial plasma collection markets. Various factors related to the supply of plasma and the production of plasma derived pharmaceuticals also affect the demand, including:

·                  There has been significant industry consolidation among plasma collectors and fractionators. Industry consolidation impacts us when a collector changes the total number of its collection centers, the total number of collections performed per center or changes the plasma collection system (Haemonetics or competitive technology) used to perform some or all of those collections.

·                  The supply of source plasma also affects demand for additional collections of source plasma. We believe that the inventory of source plasma has returned to normal levels in the U.S. and in Europe. In Japan, there is a still an oversupply of plasma.

·                  The newer plasma fractionation facilities are more efficient in their production processes, utilizing less plasma to make similar quantities of pharmaceuticals and vaccines.

·                  Reimbursement guidelines affect the demand for end product pharmaceuticals.

In fiscal year 2006, we completed the conversion of all ZLB Plasma Services (“ZLB”) collection sites to Haemonetics collection technology based on the supply agreement signed with ZLB Plasma Services (“ZLB”) in fiscal year 2005 to be its exclusive supplier of plasma collection technology in the United States.

29




Blood Bank Market

Despite modest increases in the demand for platelets in our major markets, improved collection efficiencies that increase the yield of platelets per collection have resulted in a flat market for disposables.
We continue to sell intravenous solutions that we produce under contract for pharmaceutical companies.
Red Cell Market

Red cell demands, a need for greater operating efficiency, and a stringent regulatory environment continue to drive demand for our red cell products. Our business continues to grow as we gain new customers and expand penetration at existing customer sites. Additionally, sales continue to increase as more customers have migrated to our higher-priced filtered disposable sets which support our customers’ good manufacturing processes by reducing manual processing.

Surgical Market

Our Cell Saver brand system is aimed at higher blood loss cardiovascular procedures. This part of the surgical blood salvage market is declining and will probably continue to decline due to improved surgical techniques minimizing blood loss and a decrease in the number of open-heart (bypass) surgeries performed.

The main driver of growth in the Surgical market is the lower blood loss orthopedic procedures served by our OrthoPAT system. We have transitioned our selling method in the U.S. from distributor to direct sales for the OrthoPAT system.

In fiscal 2005, we purchased a line of surgical products from Harvest Technologies Corporation. Two products are in late stage development, but the first product resulting from the acquisition, the SmartSuction HARMONY system, was launched in late fiscal 2006. The suction system, which replaces wall suction, removes blood and debris from the surgical field before the blood is processed in one of our surgical blood salvage systems.

RESULTS OF OPERATIONS

Net Revenues by Geography

 

 

April 1,

 

April 2,

 

April 3,

 

% Increase /
(Decrease)

 

% Increase /
(Decrease)

 

 

 

2006

 

2005

 

2004

 

06 vs. 05

 

05 vs. 04

 

United States

 

$

161,679

 

$

131,632

 

$

126,872

 

22.8

%

3.8

%

International

 

258,054

 

251,966

 

237,357

 

2.4

%

6.2

%

Net revenues

 

$

419,733

 

$

383,598

 

$

364,229

 

9.4

%

5.3

%

 

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 more than 50 countries around the world via a direct sales force as well as independent distributors.

30




Approximately 61%, 66%, and 65% of our revenues were generated outside the U.S. during fiscal year 2006, 2005, and 2004, respectively. During fiscal years 2006, 2005, and 2004, revenues from Japan accounted for approximately 24%, 27%, and 27% of our total revenues, respectively and revenues from Europe comprised approximately 29%, 30%, and 30% of our total revenues, respectively. These sales are primarily conducted in local currencies, specifically the Japanese Yen and the Euro. Accordingly, our results of operations are significantly affected by changes in the value of the Yen and the Euro relative to the U.S. dollar. The favorable effects of foreign exchange resulted in a 0.5% increase in sales. The remaining increase in sales from fiscal year 2005 to 2006 is 9.0%. From fiscal year 2004 to fiscal year 2005, the favorable effects of foreign exchange accounted for 5.0% of the 5.3% increase in total sales.

Please see section entitled “Foreign Exchange” in management’s discussion for a more complete discussion of how foreign currency affects our business and our strategy to manage this exposure.

By Product Type

 

 

 

 

 

 

 

 

% Increase/

 

% Increase/

 

 

 

April 1,

 

April 2,

 

April 3,

 

(Decrease)

 

(Decrease)

 

 

 

2006

 

2005

 

2004

 

06 vs. 05

 

05 vs. 04

 

Disposables

 

$

366,791

 

$

342,730

 

$

325,540

 

7.0

%

5.3

%

Misc. & service

 

27,183

 

20,173

 

22,002

 

34.7

%

(8.3

%)

Equipment

 

25,759

 

20,695

 

16,687

 

24.5

%

24.0

%

Net revenues

 

$

419,733

 

$

383,598

 

$

364,229

 

9.4

%

5.3

%

 

31




Disposables Revenue by Product Line

 

 

 

 

 

 

 

 

% Increase/

 

% Increase/

 

 

 

April 1,