FORM 10-K
WRIGHT MEDICAL GROUP INC - WMGI
Filed: March 01, 2006 (period: December 31, 2005)
Annual report which provides a comprehensive overview of the company for the past year
Table of Contents
10-K - WRIGHT MEDICAL GROUP, INC.
PART I
Risk Factors.
Item 1. Business.
Item
1A.
Item 1B. Unresolved Staff Comments.
Item 2. Properties.
Item 3. Legal Proceedings.
Item 4. Submission of Matters to a Vote of Security Holders.
PART II
Item 5. Market for Registrant s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities.
Item 6. Selected Financial Data.
Item 7. Management s Discussion and Analysis of Financial Condition and Results of
Operations.
Quantitative and Qualitative Disclosures About Market Risk.
Item
7A.
Item 8. Financial Statements and Supplementary Data.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial
Disclosure.
Controls and Procedures.
Item
9A.
Item 9B. Other Information.
PART III
Item 10. Directors and Executive Officers of the Registrant.
Item 11. Executive Compensation.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters.
Item 13. Certain Relationships and Related Transactions.
Item 14. Principal Accountant Fees and Services.
PART IV
Item 15. Exhibits and Financial Statement Schedules.
SIGNATURES
EX-21 (EX-21 SUBSIDIARIES OF THE REGISTRANT)
EX-23 (EX-23 CONSENT OF KPMG LLP)
EX-31.1 (EX-31.1 SECTION 302 CERTIFICAITON OF THE CEO)
EX-31.2 (EX-31.2 SECTION 302 CERTIFICATION OF THE CFO)
EX-32 (EX-32 SECTION 906 CERTIFICATION OF THE CEO CFO)
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
(Mark One)
�
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FORM 10-K
For the fiscal year ended December 31, 2005
OR
�
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 000-32883
WRIGHT MEDICAL GROUP, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or Other Jurisdiction
of Incorporation or Organization)
5677 Airline Road, Arlington, Tennessee
(Address of Principal Executive Offices)
13-4088127
(I.R.S. Employer
Identification No.)
38002
(Zip Code)
Registrant’s telephone number, including area code: (901) 867-9971
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, par value $.01 per share
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. � Yes �
No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. � Yes �
No
Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the
Exchange Act from their obligations under those Sections.
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 � No
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. �
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.
(Check one): Large accelerated filer � Accelerated filer � Non-accelerated filer �
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). � Yes � No
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
The aggregate market value of the voting and non-voting common equity held by nonaffiliates computed by reference to the price at
which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the
registrant’s most recently completed second fiscal quarter was $814,239,980.
As of February 24, 2006, there were 34,202,268 shares of common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
The information required by Part III is incorporated by reference from portions of the definitive proxy statement to be filed within
120 days after December 31, 2005, pursuant to Regulation 14A under the Securities Exchange Act of 1934 in connection with the
annual meeting of stockholders to be held on May 11, 2006.
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
WRIGHT MEDICAL GROUP, INC.
ANNUAL REPORT ON FORM 10-K
Table of Contents
Part I
Item 1. Business
Item 1A. Risk Factors
Item 1B. Unresolved Staff Comments
Item 2. Properties
Item 3. Legal Proceedings
Item 4. Submission of Matters to a Vote of Security Holders
Part II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Item 6. Selected Financial Data
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item 8. Financial Statements and Supplementary Data
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9A. Controls and Procedures
Item 9B. Other Information
Part III
Item 10. Directors and Executive Officers of the Registrant
Item 11. Executive Compensation
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13. Certain Relationships and Related Transactions
Item 14. Principal Accountant Fees and Services
Item 15. Exhibits and Financial Statement Schedules
Signatures
Part IV
Safe-Harbor Statement
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This annual report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this annual report, other than
statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current knowledge,
assumptions, beliefs, estimates, and expectations and express management’s current views of future performance, results, and trends.
We wish to caution readers that actual results might differ materially from those described in the forward-looking statements.
Forward-looking statements are subject to a number of risks and uncertainties, including the factors discussed in our filings with the
Securities and Exchange Commission (including those described in Item 1A and elsewhere in this annual report), which could cause
our actual results to differ materially from those described in the forward-looking statements. Although we believe that the
forward-looking statements are accurate, there can be no assurance that any forward-looking statement will prove to be accurate. A
forward-looking statement should not be regarded as a representation by us that the results described therein will be achieved. We
wish to caution readers not to place undue reliance on any forward-looking statement. The forward-looking statements are made as of
the date of this annual report, and we assume no obligation to update any forward-looking statement after this date.
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Item 1. Business.
Overview
PART I
Wright Medical Group, Inc., through Wright Medical Technology, Inc. and other operating subsidiaries, is a global orthopaedic
medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologics products.
Reconstructive joint devices are used to replace knee, hip and other joints that have deteriorated through disease or injury. Biologics
are used to replace damaged or diseased bone, to stimulate bone growth, and to provide other biological solutions for surgeons and
their patients. Within these markets, we focus on the higher-growth sectors of the orthopaedic industry, such as advanced bearing
surfaces, modular necks, and bone conserving implants within the hip market, as well as on the integration of our biologics products
into reconstructive joint procedures and other orthopaedic applications.
For the year ended December 31, 2005, we had net sales of $319.1 million and net income of $21.1 million. As of December 31, 2005,
we had total assets of $371.8 million. Detailed information on our net sales by products line and our net sales, operating income and
long-lived assets by geographic region can be found in Note 16 to the financial statements contained in Item 8 of this report.
History
We were incorporated on November 23, 1999, as a Delaware corporation (previously named Wright Acquisition Holdings, Inc.) and
had no operations until an investment group led by Warburg, Pincus Equity Partners, L.P. acquired majority ownership of our
predecessor company, Wright Medical Technology, Inc., on December 7, 1999. This transaction, which represented a recapitalization
of our predecessor company, reduced our debt and provided investment capital, and allowed us to build on the predecessor company’s
respected brand name and strong relationships with orthopaedic surgeons developed during its 50-year history.
On December 22, 1999, we acquired Cremascoli Ortho Holding, S.A., based in Toulon, France, and shortly thereafter put a new
management team in place at Cremascoli. This acquisition extended our product offerings, enhanced our product development
capabilities, and expanded our European presence. As a result of combining Cremascoli’s strength in hip reconstruction with the
predecessor company’s historical expertise in knee reconstruction and biologics, we offer a broad range of reconstructive joint devices
and biologics to orthopaedic surgeons in over 60 countries.
In 2001, we sold 7,500,000 shares of common stock in our initial public offering, which generated $84.8 million in net proceeds. In
2002, we sold 3,450,000 shares of common stock in a secondary offering which generated $49.5 million in net proceeds.
Orthopaedic Industry
It is estimated that the worldwide orthopaedic industry generated sales of approximately $21 billion in 2005. We believe this figure
will grow by 7% to 9% annually over the next three to four years. Seven multinational companies currently dominate the orthopaedic
industry, each with approximately $1.5 billion or more in annual sales. The size of these companies often leads them to concentrate
their marketing and research and development efforts on products that they believe will have a relatively high minimum threshold
level of sales. As a result, there is an opportunity for a mid-sized orthopaedic company, such as us, to focus on smaller, higher-growth
sectors of the orthopaedic market, while still offering a comprehensive product line to address the needs of its customers.
Orthopaedic devices are commonly divided into several primary sectors corresponding to the major subspecialties within the
orthopaedic field: reconstruction, trauma, arthroscopy, spine and biologics. We specialize in reconstructive joint devices and biologics
products.
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Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Reconstructive Joint Device Market
Most reconstructive joint devices are used to replace or repair joints that have deteriorated as a result of disease or injury. Despite the
availability of non-surgical treatment alternatives such as oral medications, injections and joint fluid supplementation of the knee,
severe cases of disease or injury often require reconstructive joint surgery. Reconstructive joint surgery involves the modification of
the bone area surrounding the affected joint and the insertion of one or more manufactured components, and may also involve the use
of bone cement.
The reconstructive joint device market is generally divided into the areas of knees, hips and extremities. It is estimated that the
worldwide reconstructive joint device market had sales of approximately $9 billion in 2005, with hip reconstruction and knee
reconstruction representing two of the largest sectors.
Knee Reconstruction. The knee joint involves the surfaces of three distinct bones: the lower end of the femur, the upper end of the
tibia or shin bone, and the patella or kneecap. Cartilage on any of these surfaces can be damaged due to disease or injury, leading to
pain and inflammation requiring knee reconstruction. Knee reconstruction was the largest sector of the reconstructive joint device
market in 2005, with estimated sales of approximately $4.5 billion worldwide.
Major trends in knee reconstruction include the use of alternative, better performing surface materials to extend the implant’s life and
increase conservation of the patient’s bone to minimize surgical trauma and accelerate recovery. Another significant trend in the knee
reconstruction industry is the use of more technologically advanced knees, called advanced kinematic knees, which more closely
resemble natural joint movement. Additionally, we believe that minimally invasive knee procedures, such as those for
unicompartmental repair, which replaces only one femoral condyle, as well as minimally invasive surgical techniques and
instrumentation are becoming more widely accepted.
Hip Reconstruction. The hip joint is a ball-and-socket joint which enables the wide range of motion that the hip performs in daily life.
The hip joint is most commonly replaced due to degeneration of the cartilage between the head of the femur (the ball) and the
acetabulum or hollow portion of the pelvis (the socket). This degeneration causes pain, stiffness and a reduction in hip mobility. It is
estimated that the worldwide hip reconstruction market had sales of approximately $4 billion in 2005.
Similar to the knee reconstruction market, major trends in hip replacement procedures and implants are to extend implant life and to
preserve bone stock for possible future procedures. New products have been developed that incorporate advances in bearing surfaces
from the traditional polyethylene surface. Polyethylene surfaces may create wear debris that can lead to potential loosening of the
implant. These alternative bearing surfaces include metal-on-metal, cross-linked polyethelene and ceramic-on-ceramic combinations,
which exhibit improved wear characteristics and lead to longer implant life. In addition to advances in bearing surfaces, implants that
preserve more natural bone have been developed in order to minimize surgical trauma and recovery time for patients. These implants,
known as bone-conserving implants, leave more of the hip bones intact, which is beneficial given the likelihood of future revision
replacement procedures as the average patient’s lifetime increases. Bone-conserving procedures are intended to enable patients to
delay their first total hip procedure and may significantly increase the time from the first procedure to the time when a revision
replacement implant is required.
Extremity Reconstruction. Extremity reconstruction involves implanting devices to replace or reconstruct injured or diseased joints
such as the finger, toe, wrist, elbow, foot, ankle and shoulder. It is estimated that the extremity reconstruction market had sales of
approximately $400 million worldwide in 2005. Major trends in extremity reconstruction include unique distal radius (wrist) and foot
and ankle fixation devices.
Biologics Market
The biologics market is one of the fastest growing sectors of the orthopaedic market. Biologics products use both biological
tissue-based and synthetic materials to regenerate damaged or diseased bone and to repair damaged tissue. These products stimulate
the body’s natural regenerative capabilities to minimize or delay the need for invasive implant surgery, replace damaged or diseased
bone, and provide other biological solutions for surgeons and their patients.
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Table of Contents
Biologics products are used in spinal fusions, trauma fractures, joint replacements, and cranio-maxillofacial procedures and represent
an alternative solution to autograft, a procedure that involves harvesting a patient’s own bone or soft tissue. Currently, there are three
main types of biological bone grafting products, which are osteoconductive, osteoinductive and combined
osteoconductive/osteoinductive, that refer to the way in which the materials affect bone growth. Osteoconductive materials serve as a
scaffold that supports the formation of bone but does not trigger new bone growth, whereas osteoinductive materials induce bone
growth. Other biologics products enable the repair of soft tissue. These products provide favorable microenvironments for quick
revascularization and cell proliferation. It is estimated that the biologics market generated sales of approximately $900 million
worldwide in 2005.
Government Regulation
United States
Our products are strictly regulated by the United States Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic
Act (FDC Act). Some of our products are also regulated by state agencies. FDA regulations and the requirements of the FDC Act
affect the pre-clinical and clinical testing, design, manufacture, safety, efficacy, labeling, storage, recordkeeping, advertising and
promotion of our medical device products. Our tissue-based products are subject to FDA regulations, the National Organ Transplant
Act (NOTA), accreditation from the American Association of Tissue Banks (AATB), and various state agency regulations.
Generally, before we can market a new medical device, marketing clearance from the FDA must be obtained through a premarket
notification under Section 510(k) of the FDC Act or the FDA’s approval of a premarket approval (PMA) application. The FDA
typically grants a 510(k) clearance if the applicant can establish that the device is substantially equivalent to a predicate device. It
generally takes three months from the date of a 510(k) submission to obtain clearance, but it may take longer, particularly if a clinical
trial is required. The FDA may find that a 510(k) is not appropriate or that substantial equivalence has not been shown and, as a result,
will require a PMA application.
PMA applications must be supported by valid scientific evidence to demonstrate the safety and effectiveness of the device, typically
including the results of human clinical trials, bench tests and laboratory and animal studies. The PMA application must also contain a
complete description of the device and its components, and a detailed description of the methods, facilities and controls used to
manufacture the device. In addition, the submission must include the proposed labeling and any training materials. The PMA
application process can be expensive and generally takes significantly longer than the 510(k) process. Additionally, the FDA may
never approve the PMA application. As part of the PMA application review process, the FDA generally will conduct an inspection of
the manufacturer’s facilities to ensure compliance with applicable quality system regulatory requirements, which include quality
control testing, control documentation and other quality assurance procedures.
If human clinical trials of a medical device are required, either for a 510(k) submission or a PMA application, and the device presents
a significant risk, the sponsor of the trial, usually the manufacturer or the distributor of the device, must file an investigational device
exemption (IDE) application prior to commencing human clinical trials. The IDE application must be supported by data, typically
including the results of animal and/or laboratory testing. If the IDE application is approved by the FDA and one or more institutional
review boards (IRBs), human clinical trials may begin at a specific number of investigational sites with a specific number of patients,
as approved by the FDA. If the device presents a nonsignificant risk to the patient, a sponsor may begin the clinical trial after
obtaining approval for the trial by one or more IRBs without separate approval from the FDA. Submission of an IDE does not give
assurance that the FDA will approve the IDE and, if it is approved, there can be no assurance the FDA will determine that the data
derived from the trials support the safety and effectiveness of the device or warrant the continuation of clinical trials. An IDE
supplement must be submitted to and approved by the FDA before a sponsor or investigator may make a change to the investigational
plan that may affect its scientific soundness, study indication or the rights, safety or welfare of human subjects. The trial must also
comply with the FDA’s IDE regulations and informed consent must be obtained from each subject. If the FDA believes we are not in
compliance
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Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
with the law, it can institute proceedings to detain or seize products, issue a market withdrawal, enjoin future violations and seek civil
and criminal penalties against us and our officers and employees. If we fail to comply with these regulatory requirements, our
business, financial condition and results of operations could be harmed.
Most of our products are approved through the 510(k) premarket notification process. We have conducted clinical trials to support
many of our regulatory approvals. Regulations regarding the manufacture and sale of our products are subject to change. We cannot
predict the effect, if any, that these changes might have on our business, financial condition and results of operations. In particular, the
FDA has statutory authority to regulate allograft-based products, processing and materials. The FDA has been working to establish a
more comprehensive regulatory framework for allograft-based products, which are principally derived from human cadaveric tissue.
The framework developed by the FDA establishes criteria for determining whether a particular human tissue-based product will be
classified as human tissue, a medical device or biologic drug requiring premarket clearance or approval. All tissue-based products are
subject to extensive FDA regulation, including a requirement that ensures that diseases are not transmitted to tissue recipients. The
FDA has also proposed extensive additional regulations that would govern the processing and distribution of all allograft products.
Consent to use the donor’s tissue must also be obtained. If a tissue-based product is considered tissue, it does not require FDA
clearance or approval before being marketed. If it is considered a device, or a biologic drug, then FDA clearance or approval may be
required.
In addition to granting approvals for our products, the FDA and international regulatory authorities periodically inspect us for
compliance with regulatory requirements that apply to medical devices marketed in the U.S. and internationally. These requirements
include labeling regulations, manufacturing regulations, quality system regulations, regulations governing unapproved or off-label
uses, and medical device regulations. Medical device regulations require a manufacturer to report to the FDA serious adverse events
or certain types of malfunctions involving its products. The FDA periodically inspects device and drug manufacturing facilities in the
U.S. in order to assure compliance with applicable quality system regulations. The FDA last inspected our Arlington, Tennessee
manufacturing facility in March 2005, and our Toulon, France manufacturing facility in October 2003.
International
We obtain required regulatory approvals and comply with extensive regulations governing product safety, quality, manufacturing and
reimbursement processes in order to market our products in all major foreign markets. These regulations vary significantly from
country to country and with respect to the nature of the particular medical device. The time required to obtain these foreign approvals
to market our products may be longer or shorter than that required in the U.S., and requirements for such approval may differ from
FDA requirements.
All of our products sold internationally are subject to certain foreign regulatory approvals. In order to market our product devices in
the member countries of the European Union, we are required to comply with the Medical Devices Directives and obtain CE mark
certification. CE mark certification is the European symbol of adherence to quality assurance standards and compliance with
applicable European Medical Devices Directives. Under the Medical Devices Directives, all medical devices including active implants
must qualify for CE marking. We also are required to comply with other foreign regulations such as obtaining MHLW (Ministry of
Health Labor and Welfare) approval in Japan, HPB (Health Protection Branch) approval in Canada, and TGA (Therapeutic Goods
Administration) approval in Australia as a few examples.
Products
We operate as one reportable segment, offering products in four primary market sectors: knee reconstruction, hip reconstruction,
extremity reconstruction, and biologics.
Knee Reconstruction
Our knee reconstruction product portfolio strategically positions us in the areas of total knee reconstruction, revision replacement
implants, and limb preservation products. These products provide the surgeon with a continuum of treatment options for improving
patient care. We differentiate our products through innovative design features that reproduce movement and stability, resulting in
products that more closely resemble a healthy knee. Additionally, we provide a broad array of Open and Minimally Invasive Surgery
surgical instrumentation to accommodate surgeon
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Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
and patient preference. Minimally Invasive Surgery (MIS) or Least Invasive Surgery (LIS) has gained momentum in recent history
due to the smaller incision and minimal disruption of soft tissues, which can significantly reduce recovery times. Faster recovery and
rehabilitation times are important to the growing market of younger, more active patients who want a quick return to their active
lifestyles. The MIS surgical instrumentation is not only tissue sparing but more accurate and can perform traditional/open procedures
as well. This is important for surgeons because not every patient clinically qualifies for the small incision surgical technique and they
can standardize with one set of instruments regardless of open or MIS surgical technique.
The ADVANCE ® Knee System is our primary knee product line offering. There are several innovative product offerings within the
ADVANCE ® Knee System product line, one of which is the ADVANCE ® Medial Pivot Knee. The understanding of knee movement
and function has advanced significantly over the past several years, and we believe the ADVANCE ® Medial Pivot Knee is the first
knee to be mass marketed that takes full advantage of the strides made in understanding the knee joint. The ADVANCE ® Medial
Pivot Knee is designed to approximate the movement and function of a healthy knee by using a unique spherical medial feature.
Overall, we believe the ADVANCE ® Medial Pivot Knee more closely approximates natural knee motion, improves clinical
performance and provides excellent range of motion.
Our ADVANCE ® Double High Knee Tibial Insert is designed to address the needs of surgeons that desire to retain the posterior
cruciate ligament (PCL). The insert design addresses an adverse phenomenon, known as paradoxical motion, that often occurs with
other PCL retaining knee systems. In general, total knee systems are designed to be used either with or without the patient’s PCL.
Most knee implant designs used with the PCL are based on the theory that the ligament will provide stability and increased flexion.
Due to the phenomenon of paradoxical motion, however, small amounts of uncontrolled sliding can occur between the replaced
femoral and tibial surfaces. This movement prevents the prosthetic knee from flexing in a stable, consistent manner like a normal knee
and can result in abnormal gait and reduced flexion. The ADVANCE ® Double-High Knee component can minimize paradoxical
motion through an articulation designed to provide stability and maximize PCL function.
Our REPIPHYSIS® Technology allows for non-invasive expansion of any long bone where lengthening is needed. This technology,
which we exclusively license, can be incorporated into a prosthetic implant and subsequently adjusted non-invasively when
lengthening of the implant is needed. The most common application of this breakthrough technology is in the field of pediatric
oncology, where growing children can have the bones attached to their hip or knee implant lengthened non-invasively, thus
eliminating the need for more frequent surgeries and anesthesia.
Hip Reconstruction
We offer a comprehensive line of products for hip joint reconstruction. This product portfolio provides offerings in the areas of
bone-conserving implants, total hip reconstruction, revision replacement implants, and limb preservation. Additionally, our hip
products offer a combination of unique, innovative modular designs, a complete portfolio of advanced surface bearing materials,
including ceramic-on-ceramic and metal-on-metal articulations, and innovative technology in surface replacement implants. We are
therefore able to offer surgeons and their patients a full continuum of treatment options.
Our hip product portfolio includes our LIFETIME SOLUTIONS™ plan, a three-tiered lifetime solution for the surgical treatment of
hip pain that incorporates our CONSERVE® family of products. Our CONSERVE ® family of products work together to provide
bone-conserving approaches to hip resurfacing and hip replacement. The first offering in our LIFETIME SOLUTIONS™ plan is a
partial hip resurfacing procedure performed with the CONSERVE® Partial Resurfacing Implant. This procedure preserves the femoral
head and neck and does not invade the femoral canal. In addition, the acetabulum is left completely intact. The CONSERVE ® Partial
Resurfacing Implant’s conservative restoration provides a better solution for the patient by leaving maximum bone for future surgical
procedures.
The second offering in our LIFETIME SOLUTIONS™ plan is a total hip resurfacing procedure using the CONSERVE ® Plus
Resurfacing Implant. This implant retains the femoral head and neck and resurfaces the acetabulum in a bone conserving manner,
helping to preserve the patient’s natural motion in the joint. Our CONSERVE ® Plus Resurfacing Implant is available outside the
U.S., but is pending FDA approval for the U.S. market.
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The third offering within LIFETIME SOLUTIONS™ is a primary total hip replacement. The CONSERVE ® Total Implant with
BFH™ Technology mimics the natural kinematics of the hip by replacing the natural femoral head with a large diameter femoral head
implant. The result of this increased femoral head diameter is a significant reduction in the potential for dislocation. Coupled with our
PROFEMUR® Hip System, we are able to provide surgeons and patients a minimally invasive option for their total hip replacement.
Following the creation of the CONSERVE® family of products, we launched our new A-Class™ Advanced Bearings Technology
platform in 2005. The first offering from this platform is the new A-Class™ Metal for the CONSERVE ® Total Implant with BFH™
Technology. Laboratory tests suggest that over the life of the implant, this new metal-on-metal bearing will result in significantly less
wear than current metal-on-metal bearing surfaces. This new bearing is coupled with the BFH™ Technology for increased jump
distance and low dislocation rates. In addition to the A-Class™ Metal, we also introduced our A-Class™ Poly cross-linked
polyethylene acetabular bearing for the LINEAGE® Acebabular system. This advancement now gives us the only cup on the market
with ceramic, metal and cross-linked poly inserts.
In our hip replacement product lines, the LINEAGE® Acetabular System provides the surgeon with the option to interchangeably use
either ceramic-on-ceramic, metal-on-metal, or metal-on-cross-linked-polyethylene acetabular bearing surfaces for use with a common
metal acetabular shell, thus offering maximum flexibility to the surgeon while minimizing inventory levels. The standard for
replacement of the acetabulum, or socket, in the hip joint is a two-piece system consisting of a metal shell with a polyethylene liner.
The polyethylene component serves as a bearing surface for the head of the femoral component, or ball. Alternative hard bearing
materials, such as metal-on-metal and ceramic-on-ceramic, have been introduced in recent years. These options, ceramic-on-ceramic
in particular, significantly reduce wear debris from articulation and therefore provide an optimal solution for young and active
patients.
The ANCA-FIT™ Hip System, a traditional hip replacement system designed in Europe, has received clinical acceptance in Europe
for eight years. The ANCA-FIT™ Hip System includes the femoral stem family of components as well as the acetabular shell family.
The femoral stem is a non-cemented, anatomical stem with HA, or hydroxylapatite, coating. It features the patented modular
interchangeable neck option found in other modular stems such as the PROFEMUR® Hip System. The acetabular shell is a titanium
porous coated shell, designed to accept either ceramic or polyethylene liners.
The PROFEMUR® Hip System provides surgeons with modularity in hip implant procedures. Our PROFEMUR® Hip System
features a patented modular femoral neck, which allows the surgeon to make final adjustments in leg length, offset and version to the
implant as the last step in the procedure in order to accommodate each patient’s unique anatomy. The PROFEMUR ® Hip System is
offered with a variety of femoral stem designs to provide a comprehensive implant system to appeal to any physician’s preference in
implant selection. Our principal PROFEMUR® stem offerings include our PROFEMUR® Z, PROFEMUR® Plasma Z, PROFEMUR®
S PROFEMUR® Tapered and the PROFEMUR ® Renaissance stems.
The PERFECTA® Hip System is the basic platform for our traditional hip stem product line. This system provides a full range of
fixation options including press fit and cemented versions, and offers a wide selection of geometries in order to meet the needs of the
patient’s anatomical requirements as well as the surgeon’s preferences. This product allows surgeons the flexibility to match the
implant to each patient’s unique requirements. The PERFECTA ® Hip System has over ten years of clinical success worldwide.
The GUARDIAN® Limb Salvage System offers options for patients with significant bone loss due to cancer, trauma, or previous
surgical procedures. This modular system, with an array of options in a multitude of sizes and complete inter-changeability, provides
the surgeon with the ability to meet a variety of patient needs. The GUARDIAN® Proximal Tibial Implant was developed for patients
with significant bone loss in the tibial bone. The GUARDIAN® Revision Hinge Implant, another of the products offered within the
system, was developed for use in revision
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surgeries where both bone loss and ligament deficiencies are present. The GUARDIAN® Total Femur is used in rare cases where the
entire femur must be replaced.
Extremity Reconstruction
We offer extremity products for the hand, wrist, elbow, shoulder, foot and ankle in a number of markets worldwide. Our small joint
orthopaedic implants have many years of successful clinical history. We believe we are one of the recognized leaders in radial head
repair and finger and toe implants.
Our EVOLVE ® Modular Radial Head Replacement Prosthesis addresses the need for modularity in this anatomically highly-variable
joint, and is the market leading radial head prosthesis. The EVOLVE ® Modular Radial Head device provides 150 different
combinations of heads and stems allowing the surgeon to choose implant heads and stems to accommodate the unpredictable anatomy
of each patient. The smooth stem design allows for rotational motion at the implant/bone interface and radiocapitellar articulation,
potentially reducing capitellar wear. In the first quarter of 2005, we released our EVOLVE ® Radial Head Plating System for surgeons
who wish to repair rather than replace the damaged radial head. With prosthesis and plating, we believe we have become the vendor of
choice for repair of radial head fractures.
In mid-February 2005, we launched our CHARLOTTE™ Foot and Ankle System, a comprehensive offering of fixation products for
foot and ankle surgery. The CHARLOTTE™ Foot and Ankle System includes six products that feature advanced design elements for
simplicity, versatility, and high performance. The CHARLOTTE™ Foot and Ankle System offers a complete range of options for the
most common foot and ankle surgical needs. The CHARLOTTE™ Foot and Ankle System replaced products supplied by a third party
vendor pursuant to a distribution agreement that expired in the first quarter of 2005.
The LOCON-T® and LOCON-VLS® Distal Radius Plating Systems provide surgeons with anatomically designed, stainless steel
plates used in the repair of distal radial fractures. In designing both plating systems, we utilized thin, high-strength stainless steel with
low profile screws, which have been demonstrated clinically to lessen potential for tendon irritation and/or rupture, which are
complications that historically have resulted from this type of surgical repair.
Our MICRONAIL™ intramedullary wrist fracture repair system is a next-generation, minimally invasive treatment for distal radius
fractures that provides immediate fracture stabilization with minimal soft tissue disruption. The result is rapid recovery of hand and
wrist functions as demonstrated by an initial clinical trial.
The ORTHOSPHERE® Carpometacarpal Implant for the repair of the basal thumb joint is constructed from implant-grade ceramic,
which reduces wear and increases biocompatibility compared to other implant materials. By providing an alternative to the harvesting
of the patient’s own soft tissues as a spacer for the repaired carpometacarpal joint, the ORTHOSPHERE ® Carpometacarpal Implant
reduces morbidity and operating time in appropriately selected patients. We have received FDA 510(k) clearance to market this device
in foot and ankle procedures such as the tarso-metatarsal joint.
Biologics
We offer a broad line of biologics products that are used to replace and repair damaged or diseased bone, tendons, soft tissues and
other biological solutions for surgeons and their patients. These products focus on biological musculoskeletal repair by utilizing
synthetic and human tissue-based materials. Internationally, we offer bone graft products incorporating antibiotic delivery and
anti-adhesion products.
GRAFTJACKET® Regenerative Tissue Matrix is a soft tissue graft designed for augmentation of tendon and ligament repairs such as
those of the rotator cuff (shoulder) and Achilles tendon in the ankle. By augmenting the strength of the tendon repair and incorporating
biologically, GRAFTJACKET® increases surgeons’ confidence in the surgical outcome. GRAFTJACKET ® Maxforce Extreme is a
high strength form of GRAFTJACKET®, which provides maximum suture holding power for the most challenging of tendon and
ligament repairs.
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GRAFTJACKET® matrix for ulcer repair is designed to repair challenging diabetic ulcers of the foot, the primary cause of hospital
admissions for all individuals with diabetes. More than two-thirds of the amputations administered each year are performed on
individuals with diabetes, often because of difficulties associated with diabetic foot ulcers. GRAFTJACKET® matrix for ulcer repair
appears to be the first chronic wound graft to demonstrate the ability to reliably repair deep foot wounds, which have a much higher
risk of leading to amputation. Unlike other diabetic foot ulcer products, GRAFTJACKET® matrix generally requires only one
application to treat the foot ulcer, reducing the time and cost of treatment. In January 2005, we received stand-alone Medicare
reimbursement codes for the use of our GRAFTJACKET® matrix in the repair of diabetes-related foot ulcers. We believe that this
development presents a significant opportunity, which we are pursuing aggressively.
Our OSTEOSET® bone graft substitute is a synthetic bone graft substitute made of surgical grade calcium sulfate. OSTEOSET® bone
graft provides an attractive alternative to autograft, because it facilitates bone regeneration without requiring a painful, secondary
bone-harvesting procedure. Additionally, being purely synthetic, OSTEOSET ® pellets are cleared for use in infected sites, an
advantage over tissue-based material. The human body resorbs the OSTEOSET® material at a rate close to the rate that new bone
grows. We offer surgeons the option of custom-molding their own beads in the operating room using the OSTEOSET ® Resorbable
Bead Kit, which is available in mixable powder form. OSTEOSET® 2 DBM graft is a unique bone graft substitute incorporating
demineralized bone matrix (DBM) into OSTEOSET® surgical-grade calcium sulfate pellets. These two bone graft materials, each with
a long clinical history, provide an ideal combination of osteoinduction and osteoconduction for guided bone regeneration. Our surgical
grade calcium sulfate is manufactured using proprietary processes that consistently produce a high quality product. Our OSTEOSET®
T medicated pellets, which contain tobramycin sulfate, are currently one of the few resorbable bone void fillers available in
international markets for the prevention and treatment of osteomyelitis, an acute or chronic infection of the bone.
ALLOMATRIX ® Injectable Putty combines a high content of DBM with our proprietary surgical grade calcium sulfate carrier. The
combination provides an injectable putty with the osteoinductive properties of DBM as well as exceptional handling qualities. This
product has been well received by surgeons. Another combination we offer is ALLOMATRIX ® C bone graft putty, which includes
the addition of cancellous bone granules. The addition of the bone granules increases the stiffness of the material and thereby
improves handling characteristics, increases osteoconductivity scaffold, and provides more structural support. Our ALLOMATRIX ®
Custom bone graft putty allows surgeons to customize the amount of bone granules to add to the putty based on its surgical
application. Most recently, we introduced ALLOMATRIX ® DR Graft, which is ALLOMATRIX ® putty that has been optimized for
application in smaller fractures due to the smaller particle size of its cancellous bone granules and the application-specific volume in
which it is marketed.
MIIG® 115 Minimally Invasive Injectable Graft is an injectable form of our surgical grade calcium sulfate paste that hardens in the
body. MIIG® 115 graft combines the operative flexibility of an injectable substance with the clinically proven osteoconductive
properties of our OSTEOSET® material. MIIG® 115 graft is ideally suited for use in non-loaded traumatic fractures such as the distal
radius and tibial plateau.
MIIG® X3 High Strength Injectable Graft is an addition to the family of MIIG® products for the minimally invasive treatment of bone
defects. It is an injectable calcium sulfate that hardens after placement, provides intraoperative support, and resorbs over time as it is
replaced by new bone. Compared to the MIIG® 115 graft, the principle advantages of the MIIG® X3 graft is that it has 2.6 times
greater compressive strength, easier injectability, and a longer working time. MIIG® X3 graft has several competitive advantages over
injectable calcium phosphate products on the market, including its ability to be drilled or tapped for the placement of final hardware.
Additionally, it poses less risk of damage to the joint cartilage upon extravasation (i.e., leakage into the joint space).
MIIG® X3 HiVisc graft is an advanced formulation of MIIG® X3 graft specially designed for management of complex compression
fractures. The modified viscosity and extended working time of MIIG® X3 HiVisc graft reduces the potential for extravasation of
material into joint spaces and provides greater operative flexibility to the surgeon for very challenging fractures.
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IGNITE® Power Mix is a bone repair stimulus that combines calcium sulfate, DBM and autologous bone marrow aspirate (BMA) for
the treatment of problem fractures and delayed non-unions. This combination of materials provides the surgeon and patient with all
three critical elements that a bone graft material can offer — an osteoconductive scaffold with both osteoinductive and osteogenic
capacity through the use of DBM and BMA, respectively. The IGNITE ® ICS kit also provides specially-designed instrumentation
both to procure BMA and to prepare the fracture site for the grafting procedure using a minimally invasive technique.
CELLPLEX™ TCP Synthetic Cancellous Bone is an osteoconductive, resorbable tricalcium phosphate (TCP) provided in granular
form that simulates the structure of cancellous bone. It has been engineered with a highly porous, interconnected structure to facilitate
the ingrowth of new bone throughout the material. Compared to other commercially available TCP products, its benefits include a
superior compressive strength and physical characteristics that more closely resemble that of natural cancellous bone. It is an excellent
carrier of BMA and is packaged in the INFILTRATE™ Marrow Infusion Chamber to provide surgeons a simple option for combining
BMA with the CELLPLEX™ TCP, thereby adding an osteogenic component to the synthetic graft.
ADCON® Gel products are designed to reduce adhesion (scar) formation following lumbar spine (ADCON®-L Gel) and peripheral
tendon/nerve (ADCON®-T/N Gel) procedures, which can cause post-operative pain and potentially lead to revision procedures
(secondary surgery). Both ADCON®-L Gel and ADCON ®-T/N Gel are commercially available internationally, but are currently not
available for sale in the U.S. Our ADCON®-L Gel had previously received regulatory clearance with the FDA in 1998. In 2000, the
FDA determined that the provisions of its Application Integrity Policy (AIP) would be applied to the prior owner of the ADCON ® Gel
technology due to its violations of Good Clinical Practices in the conduct, analysis, and reporting of data specific to the U.S. Clinical
Study of ADCON®-L Gel. In 2003, the FDA lifted the AIP status of the prior owner, which subsequently allowed us, as the new
owner of the ADCON® Gel technology, to present the FDA with the clinical data intended to support the return of ADCON ®-L Gel to
the U.S. market. In 2005, we withdrew our PMA application with the FDA for our ADCON ® Gel product. Management is evaluating
whether to continue to pursue re-submission for this product. If re-submitted, there can be no assurance that the FDA will accept
another submission for filing in a timely manner or at all.
Product Development
Our research and development staff focuses on developing new products in the knee, hip and extremity reconstruction and biologics
markets and on expanding our current product offerings and the markets in which they are offered. Realizing that new product
offerings are a key to future success, we are committed to a strong research and development program. Research and development
expenses totaled $22.3 million, $18.4 million and $16.2 million in 2005, 2004 and 2003, respectively. We are presently targeting an
overall level of research and development spending, exclusive of non-cash stock-based compensation, of approximately 7.5% of net
sales for 2006.
We continue to collaborate with surgeon advisory panels that provide advice on market trends and assist with the development and
clinical testing of our products. We believe these surgeon advisors are prominent in the field of orthopaedics. We also partner
periodically with other industry participants, particularly in the biologics area, to develop new products.
In the knee, hip and extremity reconstruction areas, our research and development activities focus on expanding the continuum of
products that span the life of implant patients, from early intervention, such as bone-conserving implants, to primary implants, revision
replacement implants, and limb preservation implants. We continue to explore and develop advanced bearing and fixation surfaces
that improve the clinical performance of reconstructive devices, including ceramic-on-ceramic and low-wear metal-on-metal surfaces.
Further, we provide minimally invasive tissue sparing techniques that allow patients to quickly return to work and resume their daily
activities. In 2004, we introduced the ODYSSEY™ Tissue Preserving Initiative, which is a minimally invasive surgery program for
hip, knee, and total joint resurfacing procedures. In 2006, we anticipate that we will continue to focus on additional minimally
invasive techniques and instrumentation for further surgical applications including the knee.
In the biologics area, we have a variety of research and development projects underway that are designed to further expand our
presence in this market. Such projects include developing materials for new biologics applications as well as the integration of
biologics products into reconstructive joint procedures and other orthopaedic applications.
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New products, procedures and techniques that we introduced across all product lines since 2003 include, but are not limited to, the
MIIG® X3 High Strength Injectable Graft, the GRAFTJACKET® matrix for ulcer repair, the CELLPLEX™ TCP Synthetic
Cancellous Bone, the CONSERVE® Total Implant with BFH ™ Technology, the MIIG ® X3 HiVisc graft, the OSTEOSET® 2 DBM
Pellets, the ADVANCE ® Double-High Knee Tibial Insert, the MICRONAIL™ intramedullary distal radius implant, the ODYSSEY™
Tissue Preserving Initiative for Hip and Knee procedures, the PROFEMUR® Tapered Stem Total Hip System, the CHARLOTTE™
Foot and Ankle System, the MIIG® HV Procedure Kit, the GRAFTJACKET® Regenerative Tissue Matrix Maxforce Extreme, the
ODYSSEY™ Minimally Invasive Knee Instrument, the CONSERVE® Total A-Class™ Advanced Metal with BFH™ Technology hip
system, and the PROFEMUR® Renaissance™ hip stem.
Manufacturing and Supply
We operate manufacturing facilities in Arlington, Tennessee, and Toulon, France. These facilities primarily produce orthopaedic
implants and some of the related surgical instrumentation used to prepare the bone surfaces and cavities during the surgical procedure.
The majority of our surgical instrumentation is produced to our specifications by qualified subcontractors who serve medical device
companies.
During the past year, we have continued to modernize both production facilities through changes to the physical appearance and
layout, and additions of new production and quality control equipment to meet the evolving needs of our product specifications and
designs. In seeking to optimize our manufacturing operations, we have adopted many sophisticated manufacturing practices, such as
lean manufacturing and Six Sigma quality programs, which are designed to lower lead times, minimize waste and reduce inventory.
We have a wide breadth of manufacturing capabilities at both facilities, including skilled manufacturing personnel.
We rely on a limited number of suppliers for the components used in our products. Our reconstructive joint devices are produced from
various surgical grades of titanium, cobalt chrome and stainless steel, various grades of high-density polyethylenes, silicone elastomer
and ceramics. We rely on one supplier for the silicone elastomer used in our extremity products. We are aware of only two suppliers
of silicone elastomer to the medical device industry for permanent implant usage. Additionally, we rely on one supplier of ceramics
for use in our hip products. In addition, for our biologics products, we depend on a limited number of sources of DBM and cancellous
bone matrix (CBM). Two not-for-profit tissue banks supplied us with all of the DBM and CBM that we used in 2005 in our allograft
products. Further, we rely on one supplier for our GRAFTJACKET® family of soft tissue repair and graft containment products and
one supplier for our ADCON® Gel products.
We maintain a comprehensive quality assurance and quality control program, which includes documentation of all material
specifications, operating procedures, equipment maintenance and quality control methods. Our U.S. and European quality systems are
based on the requirements of ISO 9001/ISO13485 and the applicable regulations imposed by the FDA on medical device
manufacturers. We are accredited by the AATB, and we are an FDA-registered Tissue Bank. The FDA may audit our facilities at any
time.
We believe that our manufacturing facilities have adequate room for our current production requirements. See “Properties” for an
additional discussion of our facilities.
Sales and Marketing
Our sales and marketing efforts are focused on orthopaedic surgeons, who typically are the decision-makers in orthopaedic device
purchases. We have established several surgeon advisory panels consisting of surgeons who we believe are leaders in their chosen
orthopaedic specialties. We involve these surgeons and our marketing personnel in all stages of bringing a product to market – from
initial product development to product launch. As a result, we have a well educated, highly involved marketing staff and an
established, global base of well respected surgeons, who serve as advocates to promote our products in the orthopaedic community.
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We offer clinical symposia and seminars, publish advertisements and the results of clinical studies in industry publications, and offer
surgeon-to-surgeon education on our new products using our surgeon advisors in an instructional capacity. Additionally,
approximately 16,000 practicing orthopaedic surgeons in the U.S. receive information on our latest products through our distribution
network, our website, and brochure mailings.
We sell our products in the U.S. through a sales force of approximately 320 people as of December 31, 2005. This sales force
primarily consists of independent, commission-based sales representatives and distributors engaged principally in the business of
supplying orthopaedic products to hospitals in their geographic areas. Our U.S. field sales force is supported by our Tennessee-based
sales and marketing organization. Our independent distributors and sales representatives are provided opportunities for product
training throughout the year.
Our products are marketed internationally through a combination of direct sales offices in certain key international markets and
distributors in other markets. We have sales offices in France, Italy, the United Kingdom, Belgium, Germany, the Netherlands, Japan,
and Canada that employ direct sales employees and use independent sales representatives to sell our products in their respective
markets. Our products are sold in other countries in Europe, Asia, Africa, South America and Australia using stocking distribution
partners and other distribution arrangements. Stocking distributors purchase products directly from us for resale to their local
customers, with product ownership generally passing to the distributor upon shipment. As of December 31, 2005, through a
combination of our direct sales offices and approximately 100 stocking distribution partners, we had approximately 430 international
sales representatives that sell our products in over 60 countries.
Seasonal Nature of Business
We traditionally experience lower sales volumes in the third quarter months than throughout the rest of the year as a result of the
European holiday schedule. In addition, our first quarter selling, general and administrative expenses include additional expenses that
we incur in connection with the annual meeting held by the American Academy of Orthopaedic Surgeons. This meeting, which is the
largest orthopaedic meeting in the world, features the presentation of scientific papers and instructional courses for orthopaedic
surgeons. During this 3-day event, we display our most recent and innovative products for these surgeons.
Competition
Competition in the orthopaedic device industry is intense and is characterized by extensive research efforts and rapid technological
progress. Competitors include major companies in both the orthopaedic and biologics industries, as well as academic institutions and
other public and private research organizations that continue to conduct research, seek patent protection and establish arrangements for
commercializing products that will compete with our products.
The primary competitive factors facing us include price, quality, innovative design and technical capability, breadth of product line,
scale of operations and distribution capabilities. Our current and future competitors may have greater resources, more widely accepted
and innovative products, less invasive therapies, greater technical capabilities, and stronger name recognition than we do. Our ability
to compete is affected by our ability to:
•
•
•
•
•
•
•
develop new products and innovative technologies;
obtain regulatory clearance and compliance for our products;
manufacture and sell our products cost-effectively;
meet all relevant quality standards for our products and their markets;
respond to competitive pressures specific to each of our geographic markets, including our ability to enforce non-compete
agreements;
protect the proprietary technology of our products and manufacturing processes;
market our products;
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•
•
attract and retain skilled employees and sales representatives; and
maintain and establish distribution relationships.
Intellectual Property
We currently own or have licenses to use more than 100 patents and pending patent applications throughout the world. We seek to
aggressively protect technology, inventions and improvements that are considered important through the use of patents and trade
secrets in the U.S. and significant foreign markets. We manufacture and market the products both under patents and license
agreements with other parties.
Our knowledge and experience, creative product development, marketing staff, and trade secret information with respect to
manufacturing processes, materials and product design, are as important as our patents in maintaining our proprietary product lines.
As a condition of employment, we require all employees to execute a confidentiality agreement with us relating to proprietary
information and patent rights.
There can be no assurances that our patents will provide competitive advantages for our products, or that competitors will not
challenge or circumvent these rights. In addition, there can be no assurances that the United States Patent and Trademark Office
(USPTO) will issue any of our pending patent applications. The USPTO may deny or require a significant narrowing of the claims in
our pending patent applications and the patents issuing from such applications. Any patents issuing from the pending patent
applications may not provide us with significant commercial protection. We could incur substantial costs in proceedings before the
USPTO. These proceedings could result in adverse decisions as to the priority of our inventions and the narrowing or invalidation of
claims in issued patents. Additionally, the laws of some of the countries in which our products are or may be sold may not protect our
intellectual property to the same extent as the laws in the U.S. or at all.
While we do not believe that any of our products infringe any valid claims of patents or other proprietary rights held by others, there
can be no assurances that we do not infringe any patents or other proprietary rights held by them. If our products were found to
infringe any proprietary right of another party, we could be required to pay significant damages or license fees to such party or cease
production, marketing and distribution of those products. Litigation may also be necessary to enforce patent rights we hold or to
protect trade secrets or techniques we own. We are currently involved in an intellectual property lawsuit with Howmedica Osteonics
Corp., a subsidiary of Stryker Corporation. See “Legal Proceedings” for an additional discussion of this lawsuit.
We also rely on trade secrets and other unpatented proprietary technology. There can be no assurances that we can meaningfully
protect our rights in our unpatented proprietary technology or that others will not independently develop substantially equivalent
proprietary products or processes or otherwise gain access to our proprietary technology. We seek to protect our trade secrets and
proprietary know-how, in part, with confidentiality agreements with employees and consultants. There can be no assurances, however,
that the agreements will not be breached, adequate remedies for any breach would be available, or competitors will not discover or
independently develop our trade secrets.
Third-Party Reimbursement
In the United States., as well as in foreign countries, government-funded or private insurance programs, commonly known as
third-party payors, pay a significant portion of the cost of a patient’s medical expenses. A uniform policy of reimbursement does not
exist among all of these payors relative to payment of claims or enforcement of guidelines established by the Centers for Medicare and
Medicaid Services (CMS). Therefore, reimbursement can be quite different from payor to payor as well as from one region of the
country to another. We believe that reimbursement is an important factor in the success of any medical device. Consequently, we seek
to obtain reimbursement for all of our products.
Reimbursement in the U.S. depends on our ability to obtain FDA clearances and approvals to market our products. Reimbursement
also depends on our ability to demonstrate the short-term and long-term clinical and cost-effectiveness of our products from the results
obtained from our clinical experience and formal clinical trials. We present these results at major scientific and medical meetings and
publish them in respected, peer-reviewed medical journals.
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All U.S. and foreign third-party reimbursement programs, whether government funded or insured commercially, are developing
increasingly sophisticated methods of controlling health care costs through prospective reimbursement and capitation programs, group
purchasing, redesign of benefits, second opinions required prior to major surgery, careful review of bills, encouragement of healthier
lifestyles and exploration of more cost-effective methods of delivering health care. These types of programs can potentially limit the
amount which health care providers may be willing to pay for medical devices.
CMS has adopted prospective payment systems with respect to U.S.-government funded patients for services performed in hospital
settings and all approved procedures performed in ambulatory surgery centers. These prospective payment systems reimburse
hospitals according to a system of groupings that classify patients into clinically cohesive groups based on similar diagnosis and
consumption of hospital resources. The payment rate for each grouping is established by CMS based on the national average cost
associated with each category of treatment. The prospective payment is intended to reimburse the facility for all costs associated with
the patient’s care, including all medical devices.
The majority of non-government funded payors have adopted payment systems based on the prospective payment methodology
established by CMS. In some cases, however, particularly within the outpatient surgery center setting, providers continue to issue
payments based on each component of the patient’s care. In these situations, facilities charge payors separately for any medical
devices used during treatment. Reimbursement is typically based on the cost of the device plus a small administrative fee.
If adequate levels of reimbursement from third-party payors outside of the U.S. are not obtained, international sales of our products
may decline. Outside of the U.S., reimbursement systems vary significantly by country. Many foreign markets have
government-managed health care systems that govern reimbursement for new medical devices and procedures. Canada and some
European and Asian countries, in particular France, Japan, Taiwan, and Korea, have tightened reimbursement rates. Additionally,
some foreign reimbursement systems provide for limited payments in a given period and, therefore, result in extended payment
periods.
Employees
As of December 31, 2005, we employed approximately 990 people in the following areas: 410 in manufacturing, 310 in sales and
marketing, 150 in administration, and 120 in research and development. We believe that we have an excellent relationship with our
employees.
Environmental
Our operations and properties are subject to extensive federal, state, local and foreign environmental protection and health and safety
laws and regulations. These laws and regulations govern, among other things, the generation, storage, handling, use and transportation
of hazardous materials and the handling and disposal of hazardous waste generated at our facilities. Under such laws and regulations,
we are required to obtain permits from governmental authorities for some of our operations. If we violate or fail to comply with these
laws, regulations or permits, we could be fined or otherwise sanctioned by regulators. Under some environmental laws and
regulations, we could also be held responsible for all of the costs relating to any contamination at our past or present facilities and at
third-party waste disposal sites.
We believe our costs of complying with current and future environmental laws, regulations and permits, and our liabilities arising
from past or future releases of, or exposure to, hazardous substances will not materially adversely affect our business, results of
operations or financial condition, although there can be no assurances that they will not.
Available Information
Our website is located at www.wmt.com. We make available free of charge through this website our annual reports on Form 10-K,
quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed with or furnished to the
Securities and Exchange Commission (SEC) pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended,
as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.
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Item 1A. Risk Factors.
Our business and its future performance may be affected by various factors, the most significant of which are discussed below.
We are subject to substantial government regulation that could have a material adverse effect on our business
The production and marketing of our products and our ongoing research and development, preclinical testing and clinical trial
activities are subject to extensive regulation and review by numerous governmental authorities both in the U.S. and abroad. See
“Business – Government Regulation” for further details on this process. U.S. and foreign regulations govern the testing, marketing and
registration of new medical devices, in addition to regulating manufacturing practices, reporting, labeling and recordkeeping
procedures. The regulatory process requires significant time, effort and expenditures to bring our products to market, and we cannot be
assured that any of our products will be approved. Our failure to comply with applicable regulatory requirements could result in these
governmental authorities:
• imposing fines and penalties on us;
• preventing us from manufacturing or selling our products;
• bringing civil or criminal charges against us;
• delaying the introduction of our new products into the market;
• recalling or seizing our products; or
• withdrawing or denying approvals or clearances for our products.
Even if regulatory approval or clearance of a product is granted, this could result in limitations on the uses for which the product may
be labeled and promoted. Further, for a marketed product, its manufacturer and manufacturing facilities are subject to periodic review
and inspection. Subsequent discovery of problems with a product, manufacturer or facility may result in restrictions on the product,
manufacturer or facility, including withdrawal of the product from the market or other enforcement actions.
We are currently conducting clinical studies of some of our products under an IDE. Clinical studies must be conducted in compliance
with FDA regulations, or the FDA may take enforcement action. The data collected from these clinical studies will ultimately be used
to support market clearance for these products. There is no assurance that the FDA will accept the data from these clinical studies or
that it will ultimately allow market clearance for these products.
We are subject to various federal and state laws concerning health care fraud and abuse, including false claims laws, anti-kickback
laws, and physician self-referral laws. Violations of these laws can result in criminal and/or civil punishment, including fines,
imprisonment, and in the U.S., exclusion from participation in government health care programs. The scope of these laws and related
regulations are expanding and their interpretation is evolving. There is very little precedent related to these laws and regulations.
Increased funding for enforcement of these laws and regulations has resulted in greater scrutiny of marketing practices in our industry
and resulted in several government investigations by various government authorities. If a governmental authority were to determine
that we do not comply with these laws and regulations, then we and our officers and employees could be subject to criminal and civil
sanctions, including exclusion from participation in federal health care reimbursement programs.
In order to market our product devices in the member countries of the European Union (EU), we are required to comply with the
Medical Devices Directive and obtain CE mark certification. CE mark certification is the European symbol of adherence to quality
assurance standards and compliance with applicable European Medical Device Directives. Under the Medical Devices Directive, all
medical devices including active implants must qualify for CE marking. In August 2005, an EU Medical Devices Directive changed
the classification of hip, knee, and shoulder implants from class IIb to class III. The transition period for these changes begins
September 1, 2007. Upon reclassification to class III, manufacturers will be required to assemble significantly more documentation
and submit it to their Notified Body for formal approval prior to affixing the CE mark to their product and packaging. We intend to
comply with the Medical Devices Directive for all of our products manufactured and sold in the EU. However, there can be no
assurance that our products will be approved for CE marking in a timely manner or at all.
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Our biologics business is subject to emerging governmental regulations that can significantly impact our business
The FDA has statutory authority to regulate allograft-based products, processing and materials. The FDA has been working to
establish a more comprehensive regulatory framework for allograft-based products, which are principally derived from cadaveric
tissue. The framework developed by the FDA establishes criteria for determining whether a particular human tissue-based product will
be classified as human tissue, a medical device or biologic drug requiring premarket clearance or approval. All tissue-based products
are subject to extensive FDA regulation, including a requirement that ensures that diseases are not transmitted to tissue recipients. The
FDA has also proposed extensive additional regulations that would govern the processing and distribution of all allograft products.
Consent to use the donor’s tissue must also be obtained. The regulations for allograft-based products are still developing. From time to
time, the FDA reviews these products and may informally suggest to us how these products should be classified. If a human
tissue-based product is considered human tissue, it does not require FDA clearance or approval before being marketed. If it is
considered a medical device or biologic drug, then FDA clearance or approval may be required.
Additionally, our biologics business involves the procurement and transplantation of allograft tissue, which is subject to federal
regulation under NOTA. NOTA prohibits the sale of human organs, including bone and other human tissue, for valuable consideration
within the meaning of NOTA. NOTA permits the payment of reasonable expenses associated with the transportation, processing,
preservation, quality control and storage of human tissue. We currently charge our customers for these expenses. In the future, if
NOTA is amended or reinterpreted, we may not be able to charge these expenses to our customers and, as a result, our business could
be adversely affected.
Our principal allograft-based biologics offerings include ALLOMATRIX ®, GRAFTJACKET®, and IGNITE® products.
Modifications to our marketed devices may require FDA regulatory clearances or approvals or require us to cease marketing or
recall the modified devices until such clearances or approvals are obtained
When required, the products we market in the U.S. have obtained premarket notification under Section 510(k) of the FDC Act or were
exempt from the 510(k) clearance process. We have modified some of our products and product labeling since obtaining 510(k)
clearance, but we do not believe these modifications require us to submit new 510(k) notifications. However, if the FDA disagrees
with us and requires us to submit a new 510(k) notification for modifications to our existing products, we may be the subject of
enforcement actions by the FDA and be required to stop marketing the products while the FDA reviews the 510(k) notification. If the
FDA requires us to go through a lengthier, more rigorous examination than we had expected, our product introductions or
modifications could be delayed or canceled, which could cause our sales to decline. In addition, the FDA may determine that future
products will require the more costly, lengthy and uncertain PMA application process. Products that are approved through a PMA
application generally need FDA approval before they can be modified. See “Business – Government Regulation.”
If we lose one of our key suppliers, we may be unable to meet customer orders for our products in a timely manner or within our
budget
We rely on a limited number of suppliers for the components used in our products. Our reconstructive joint devices are produced from
various surgical grades of titanium, cobalt chrome and stainless steel, various grades of high-density polyethylenes, silicone elastomer
and ceramics. We rely on one supplier for the silicone elastomer used in our extremity products. We are aware of only two suppliers
of silicone elastomer to the medical device industry for permanent implant usage. Additionally, we rely on one supplier of ceramics
for use in our hip products.
In addition, for our biologics products, we presently depend upon a single supplier as our source for DBM and CBM, and any failure
to obtain DBM and CBM from this source in a timely manner will deplete levels of on-hand raw materials inventory and could
interfere with our ability to process and distribute allograft products. During 2006, we are expecting a single not-for-profit tissue bank
to meet nearly all of our DBM and CBM order requirements, a key component in the allograft products we currently produce, market
and distribute. We cannot be sure that our supply of DBM and CBM will continue to be available at current levels or will be sufficient
to meet our needs, or that future
15
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
suppliers of DBM and CBM will be free from FDA regulatory action impacting their sale of DBM and CBM. Since there is a small
number of suppliers, if we cannot continue to obtain DBM and CBM from our current source in volumes sufficient to meet our needs,
we may not be able to locate replacement sources of DBM and CBM on commercially reasonable terms, if at all. This could have the
effect of interrupting our business, which could adversely affect our sales. Further, we rely on one supplier for our GRAFTJACKET®
family of soft tissue repair and graft containment products, as well as one supplier for our ADCON® Gel products.
Suppliers of raw materials and components may decide, or be required, for reasons beyond our control to cease supplying raw
materials and components to us. FDA regulations may require additional testing of any raw materials or components from new
suppliers prior to our use of these materials or components and in the case of a device with a PMA application, we may be required to
obtain prior FDA permission, either of which could delay or prevent our access to or use of such raw materials or components.
If we fail to compete successfully in the future against our existing or potential competitors, our sales and operating results may be
negatively affected and we may not achieve future growth
The markets for our products are highly competitive and dominated by a small number of large companies. We may not be able to
meet the prices offered by our competitors, or offer products similar to or more desirable than those offered by our competitors. See
“Business – Competition.”
If we are unable to continue to develop and market new products and technologies, we may experience a decrease in demand for
our products or our products could become obsolete, and our business would suffer
We are continually engaged in product development and improvement programs, and new products represent a significant component
of our growth rate. We may be unable to compete effectively with our competitors unless we can keep up with existing or new
products and technologies in the orthopaedic implant market. If we do not continue to introduce new products and technologies, or if
those products and technologies are not accepted, we may not be successful. Additionally, our competitors’ new products and
technologies may beat our products to market, may be more effective or less expensive than our products, or may render our products
obsolete. See “Business – Competition.”
If our patents and other intellectual property rights do not adequately protect our products, we may lose market share to our
competitors and be unable to operate our business profitably
We rely on patents, trade secrets, copyrights, know-how, trademarks, license agreements and contractual provisions to establish our
intellectual property rights and protect our products. See “Business – Intellectual Property.” These legal means, however, afford only
limited protection and may not adequately protect our rights. In addition, we cannot be assured that any of our pending patent
applications will issue. The USPTO may deny or require a significant narrowing of the claims in our pending patent applications and
the patents issuing from such applications. Any patents issuing from the pending patent applications may not provide us with
significant commercial protection. We could incur substantial costs in proceedings before the USPTO. These proceedings could result
in adverse decisions as to the priority of our inventions and the narrowing or invalidation of claims in issued patents. In addition, the
laws of some of the countries in which our products are or may be sold may not protect our intellectual property to the same extent as
U.S. laws or at all. We also may be unable to protect our rights in trade secrets and unpatented proprietary technology in these
countries.
In addition, we hold licenses from third parties that are necessary to utilize certain technologies used in the design and manufacturing
of some of our products. The loss of such licenses would prevent us from manufacturing, marketing and selling these products, which
could harm our business.
We seek to protect our trade secrets, know-how and other unpatented proprietary technology, in part, with confidentiality agreements
with our employees, independent distributors and consultants. We cannot be assured, however, that the agreements will not be
breached, adequate remedies for any breach would be available, or our trade secrets, know-how, and other unpatented proprietary
technology will not otherwise become known to or independently developed by our competitors.
16
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Table of Contents
If we lose any existing or future intellectual property lawsuits, a court could require us to pay significant damages or prevent us
from selling our products
The medical device industry is litigious with respect to patents and other intellectual property rights. Companies in the medical device
industry have used intellectual property litigation to gain a competitive advantage. We are currently involved in an intellectual
property lawsuit with Howmedica Osteonics Corp., a subsidiary of Stryker Corporation, where it is alleged that our ADVANCE ®
Knee product line infringes one of Howmedica’s patents. See “Legal Proceedings” for more information regarding this lawsuit. If
Howmedica were to succeed in obtaining the relief it claims, the court could award damages to Howmedica and impose an injunction
against further sales of our product. If a monetary judgment is rendered against us, we may be forced to raise or borrow funds, as a
supplement to any available insurance claim proceeds, to pay the damages award.
In the future, we may become a party to other lawsuits involving patents or other intellectual property. A legal proceeding, regardless
of the outcome, could drain our financial resources and divert the time and effort of our management. If we lose one of these
proceedings, a court, or a similar foreign governing body, could require us to pay significant damages to third parties, require us to
seek licenses from third parties and pay ongoing royalties, require us to redesign our products, or prevent us from manufacturing,
using or selling our products. In addition to being costly, protracted litigation to defend or prosecute our intellectual property rights
could result in our customers or potential customers deferring or limiting their purchase or use of the affected products until resolution
of the litigation.
If product liability lawsuits are brought against us, our business may be harmed
The manufacture and sale of medical devices exposes us to significant risk of product liability claims. In the past, we have had a
number of product liability claims relating to our products, none of which either individually, or in the aggregate, have resulted in a
material negative impact on our business. In the future, we may be subject to additional product liability claims, some of which may
have a negative impact on our business. Additionally, we could experience a material design or manufacturing failure in our products,
a quality system failure, other safety issues, or heightened regulatory scrutiny that would warrant a recall of some of our products. Our
existing product liability insurance coverage may be inadequate to protect us from any liabilities we might incur. If a product liability
claim or series of claims is brought against us for uninsured liabilities or in excess of our insurance coverage, our business could
suffer. In addition, a recall of some of our products, whether or not the result of a product liability claim, could result in significant
costs and loss of customers.
Fluctuations in insurance expense could adversely affect our profitability
We hold a number of insurance policies, including product liability insurance, directors’ and officers’ liability insurance, property
insurance and workers’ compensation insurance. If the costs of maintaining adequate insurance coverage should increase significantly
in the future, our operating results could be materially adversely impacted.
If we cannot retain our key personnel, we will not be able to manage and operate successfully and we may not be able to meet our
strategic objectives
Our continued success depends, in part, upon key managerial, scientific, sales and technical personnel, as well as our ability to
continue to attract and retain additional highly qualified personnel. We compete for such personnel with other companies, academic
institutions, governmental entities and other organizations. There can be no assurance that we will be successful in retaining our
current personnel or in hiring or retaining qualified personnel in the future. Loss of key personnel or the inability to hire or retain
qualified personnel in the future could have a material adverse effect on our ability to operate successfully. Further, any inability on
our part to enforce non-compete arrangements related to key personnel who have left the business could have a material adverse effect
on our business.
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Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
We derive a significant portion of our sales from operations in international markets that are subject to political, economic and
social instability
We derive a significant portion of our sales from operations in international markets. Our international distribution system consists of
8 direct sales offices and approximately 100 stocking distribution partners, which combined employ approximately 430 sales
representatives who sell in over 60 countries. Most of these countries are, to some degree, subject to political, social and economic
instability. For the years ended December 31, 2005 and 2004, approximately 38% and 39%, respectively, of our net sales were derived
from our international operations. Our international sales operations expose us and our representatives, agents and distributors to risks
inherent in operating in foreign jurisdictions. These risks include:
• the imposition of additional foreign governmental controls or regulations on orthopaedic implants and biologics products;
• new export license requirements, particularly related to our biologics products;
• economic instability, including currency risk between the U.S. dollar and foreign currencies, in our target markets;
• a shortage of high-quality international salespeople and distributors;
• loss of any key personnel who possess proprietary knowledge or are otherwise important to our success in international markets;
• changes in third-party reimbursement policy that may require some of the patients who receive our implant products to directly
absorb medical costs or that may necessitate our reducing selling prices for our products;
• changes in tariffs and other trade restrictions, particularly related to the exportation of our biologics products;
• work stoppages or strikes in the health care industry, such as those that have previously affected our operations in France, Canada,
Korea and Finland in the past;
• a shortage of nurses in some of our target markets, particularly affecting our operations in France; and
• exposure to different legal and political standards due to our conducting business in over 60 countries.
Any material decrease in our foreign sales would negatively impact our profitability. Our international sales are predominately
generated in Europe. In Europe, health care regulation and reimbursement for medical devices vary significantly from country to
country. This changing environment could adversely affect our ability to sell our products in some European countries.
Our business could suffer if the medical community does not continue to accept allograft technology
New allograft products, technologies and enhancements may never achieve broad market acceptance due to numerous factors,
including:
• lack of clinical acceptance of allograft products and related technologies;
• the introduction of competitive tissue repair treatment options that render allograft products and technologies too expensive and
obsolete;
• lack of available third-party reimbursement;
• the inability to train surgeons in the use of allograft products and technologies;
• the risk of disease transmission; and
• ethical concerns about the commercial aspects of harvesting cadaveric tissue.
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Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Market acceptance will also depend on the ability to demonstrate that existing and new allografts and technologies are attractive
alternatives to existing tissue repair treatment options. To demonstrate this, we rely upon surgeon evaluations of the clinical safety,
efficacy, ease of use, reliability and cost effectiveness of our tissue repair options and technologies. Recommendations and
endorsements by influential surgeons are important to the commercial success of allograft products and technologies. In addition,
several countries, notably Japan, prohibit the use of allografts. If allograft products and technologies are not broadly accepted in the
marketplace, we may not achieve a competitive position in the market.
If adequate levels of reimbursement from third-party payors for our products are not obtained, surgeons and patients may be
reluctant to use our products and our sales may decline
In the U.S., health care providers that purchase our products generally rely on third-party payors, principally federal Medicare, state
Medicaid and private health insurance plans, to pay for all or a portion of the cost of joint reconstructive procedures and products
utilized in those procedures. We may be unable to sell our products on a profitable basis if third-party payors deny coverage or reduce
their current levels of reimbursement. Our sales depend largely on governmental health care programs and private health insurers
reimbursing patients’ medical expenses. Surgeons, hospitals and other health care providers may not purchase our products if they do
not receive satisfactory reimbursement from these third-party payors for the cost of the procedures using our products. Payors
continue to review their coverage policies carefully for existing and new therapies and can, without notice, deny coverage for
treatments that include the use of our products.
In addition, some health care providers in the U.S. have adopted or are considering a managed care system in which the providers
contract to provide comprehensive heath care for a fixed cost per person. Health care providers may attempt to control costs by
authorizing fewer elective surgical procedures, including joint reconstructive surgeries, or by requiring the use of the least expensive
implant available.
If adequate levels of reimbursement from third-party payors outside of the U.S. are not obtained, international sales of our products
may decline. Outside of the U.S., reimbursement systems vary significantly by country. Many foreign markets have
government-managed health care systems that govern reimbursement for medical devices and procedures. Canada, and some
European and Asian countries, in particular France, Japan, Taiwan, and Korea, have tightened reimbursement rates. Additionally,
some foreign reimbursement systems provide for limited payments in a given period and therefore result in extended payment periods.
See “Business – Third-Party Reimbursement” for more information regarding reimbursement in the U.S. and abroad.
If market clearance is not obtained for the re-launch of the ADCON ® Gel products and the launch of the CONSERVE® Plus
implant in the U.S., growth of our biologics and hip product lines could be impacted
Our ADCON® Gel products and our CONSERVE® Plus Resurfacing Implant are available outside the U.S.. There can be no
assurance that the sale of our ADCON® Gel or CONSERVE® Plus products in the U.S. will be cleared by the FDA in a timely manner
or at all, which could have a significant impact on the future growth of our biologics and hip product lines, respectively.
In 2005, our PMA application with the FDA for our ADCON ® Gel product was withdrawn by management. Management is
evaluating whether to continue to pursue re-submission for this product. If re-submitted, there can be no assurance that the FDA will
accept another submission for filing in a timely manner or at all.
If surgeons do not recommend and endorse our products, our sales may decline or we may be unable to increase our sales and
profits
In order for us to sell our products, surgeons must recommend and endorse them. We may not obtain the necessary recommendations
or endorsements from surgeons. Acceptance of our products depends on educating the medical community as to the distinctive
characteristics, perceived benefits, clinical efficacy and cost-effectiveness of our products compared to products of our competitors
and on training surgeons in the proper application of our products.
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Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
If a natural or man-made disaster strikes our manufacturing facilities, we could be unable to manufacture our products for a
substantial amount of time and our sales could decline
We have principally relied to date on our manufacturing facilities in Arlington, Tennessee, and Toulon, France. These facilities and
the manufacturing equipment we use to produce our products would be difficult to replace and could require substantial lead-time to
repair or replace. Our facilities may be affected by natural or man-made disasters. In the event one of our facilities was affected by a
disaster, we would be forced to rely on third-party manufacturers or shift production to our other manufacturing facility. Although we
believe we possess adequate insurance for damage to our property and the disruption of our business from casualties, such insurance
may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms or at all.
Our business plan relies on certain assumptions about the market for our products, which, if incorrect, may adversely affect our
profitability
We believe that the aging of the general population and increasingly active lifestyles will continue and that these trends will increase
the need for our orthopaedic implant products. The projected demand for our products could materially differ from actual demand if
our assumptions regarding these trends and acceptance of our products by the medical community prove to be incorrect or do not
materialize, or if non-surgical treatments gain more widespread acceptance as a viable alternative to orthopaedic implants.
Fluctuations in foreign currency exchange rates could result in declines in our reported sales and earnings
Since a majority of our international sales are denominated in local currencies and not in U.S. dollars, our reported sales and earnings
are subject to fluctuations in foreign exchange rates. Our international net sales were favorably affected by the impact of foreign
currency fluctuations totaling approximately $400,000 in 2005 and $8.1 million in 2004. We currently employ a derivative program
using 30-day foreign currency forward contracts to mitigate the risk of currency fluctuations on our intercompany receivable and
payable balances that are denominated in foreign currencies. These forward contracts are expected to offset the transactional gains and
losses on the related intercompany balances. These forward contracts are not designated as hedging instruments under SFAS No. 133,
Accounting for Derivative Instruments and Hedging Activities. Accordingly, the changes in the fair value and the settlement of the
contracts are recognized in the period incurred.
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Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Efforts to acquire and integrate other companies or product lines could adversely affect our operations and financial results
We may pursue acquisitions of other companies or product lines. Our ability to grow through acquisitions depends upon our ability to
identify, negotiate, complete and integrate suitable acquisitions and to obtain any necessary financing. Even if we complete
acquisitions, we may also experience:
• difficulties in integrating any acquired companies, personnel and products into our existing business;
• delays in realizing the benefits of the acquired company or products;
• diversion of our management’s time and attention from other business concerns;
• limited or no direct prior experience in new markets or countries we may enter;
• higher costs of integration than we anticipated; or
• difficulties in retaining key employees of the acquired business who are necessary to manage these acquisitions.
In addition, an acquisition could materially impair our operating results by causing us to incur debt or requiring us to amortize
acquisition expenses and acquired assets.
Our quarterly operating results are subject to substantial fluctuations and you should not rely on them as an indication of our
future results
Our quarterly operating results may vary significantly due to a combination of factors, many of which are beyond our control. These
factors include:
• demand for products, which historically has been lowest in the third quarter;
• our ability to meet the demand for our products;
• increased competition;
• the number, timing and significance of new products and product introductions and enhancements by us and our competitors;
• our ability to develop, introduce and market new and enhanced versions of our products on a timely basis;
• changes in pricing policies by us and our competitors;
• changes in the treatment practices of orthopaedic surgeons;
• changes in distributor relationships and sales force size and composition;
• the timing of material expense- or income-generating events and the related recognition of their associated financial impact;
• the timing of significant orders and shipments;
• availability of raw materials;
• work stoppages or strikes in the health care industry;
• changes in FDA and foreign governmental regulatory policies, requirements and enforcement practices;
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Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
• changes in accounting policies, estimates, and treatments; and
• general economic factors.
We believe that our quarterly sales and operating results may vary significantly in the future and that period-to-period comparisons of
our results of operations are not necessarily meaningful and should not be relied upon as indications of future performance. We cannot
assure you that our sales will increase or be sustained in future periods or that we will be profitable in any future period. Any shortfalls
in sales or earnings from levels expected by securities or orthopaedic industry analysts could have an immediate and significant
adverse effect on the trading price of our common stock in any given period.
We rely on our independent sales distributors and sales representatives to market and sell our products
Our success depends largely upon marketing arrangements with independent sales distributors and sales representatives, in particular
their sales and service expertise and relationships with the customers in the marketplace. Independent distributors and sales
representatives may terminate their relationships with us or devote insufficient sales efforts to our products. We do not control our
independent distributors and they may not be successful in implementing our marketing plans. Our failure to maintain our existing
relationships with our independent distributors and sales representatives could have an adverse effect on our operations. Similarly, our
failure to recruit and retain additional skilled independent sales distributors and sales representatives could have an adverse effect on
our operations. We have experienced turnover with some of our independent distributors in the past which adversely affected
short-term financial results while we transitioned to new independent distributors. While we believe these transitions have been
managed effectively, similar occurrences could happen in the future with different results which could have a greater adverse effect on
our operations than we have previously experienced.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
Our corporate headquarters and U.S. operations consist of a 74,000 square foot manufacturing facility, a 40,000 square foot
warehouse, and a 60,000 square foot administration building located on 31 acres in Arlington, Tennessee. We lease the manufacturing
facility from the Industrial Development Board of the Town of Arlington (IDB) under a lease agreement which is automatically
renewable through 2049. We may exercise an option to purchase the manufacturing facility from the IDB at a nominal price at any
time during the lease term. We lease the warehouse from the IDB under a lease agreement which has no predetermined expiration
date. We may exercise an option to purchase the warehouse from the IDB at a nominal price at any time during the lease term. We
lease a 44,000 square foot portion of the administration building from the IDB under a lease agreement that expires on July 8, 2008.
We may exercise an option to purchase the leased portion of the administration building from the IDB at a price of $101,000, which
we have pre-paid, at any time during the lease term. We own another 16,000 square foot portion of the administrative building that
was built in 2004.
We believe that our U.S. manufacturing facility has adequate room to meet our current production requirements. However, based on
our anticipated future needs for space at our corporate headquarters, we are currently conducting an analysis of our facility needs,
which could result in an expansion of our facilities at the current location, or the construction of new facilities.
Our international operations include manufacturing, warehouse, sales, research and development, and administrative facilities located
in several countries. Our primary international warehouse is located in a leased facility in Toulon, France. Our primary international
research and development facility is located in leased facilities in Milan, Italy. Our sales offices in France, Italy, the United Kingdom,
Belgium, Japan, and Canada also include warehouse and administrative space.
22
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Item 3. Legal Proceedings.
From time to time, we are subject to lawsuits and claims which arise out of our operations in the normal course of business. We are
the plaintiff or defendant in various litigation matters in the ordinary course of business, some of which involve claims for damages
that are substantial in amount. We believe that the disposition of claims currently pending, including the matters discussed below, will
not have a material adverse effect on our financial position or results of operations.
Howmedica Osteonics Corp. v. Wright Medical Technology, Inc.
In 2000, Howmedica Osteonics Corp., a subsidiary of Stryker Corporation, filed a lawsuit against us in the United States District
Court for the District of New Jersey alleging that we infringed Howmedica’s U.S. Patent No. 5,824,100 related to our ADVANCE ®
Knee product line. The lawsuit seeks an order of infringement, injunctive relief, unspecified damages and various other costs and
relief and could impact a substantial portion of our knee product line. We believe, however, that we have strong defenses against
Howmedica’s claims and thus are vigorously defending this lawsuit. In November 2005, the court issued a Markman ruling on claim
construction holding that our products do not literally infringe the claims of Howmedica’s patent. No trial date has been set in this
matter. We are unable to estimate the potential liability, if any, with respect to the claims, and accordingly, no provision has been
made for this contingency as of December 31, 2005. We believe that the claims are covered in part by our patent infringement
insurance. We do not believe that the outcome of this lawsuit will have a material adverse effect on our financial position or results of
operations.
CERAbio, LLC and Phillips Plastics Corporation v. Wright Medical Technology, Inc.
In 2002, pursuant to a purchase and royalty agreement with CERAbio LLC (CERAbio), we purchased assets consisting primarily of
completed technology for $3.0 million and recorded this entire amount as an intangible asset. Of this purchase price, $1.5 million was
paid upon signing the purchase agreement. The remaining $1.5 million is recorded in “Accrued expenses and other current liabilities”
in the consolidated balance sheet and is payable if certain conditions under the agreement are satisfied. The agreement also provides
for specified future royalties contingent upon sales of products related to the acquired technology. Believing that the contractual
obligations for payment had not been met, we disputed whether the second payment and royalties had been earned. In 2003, CERAbio
and Phillips Plastics Corporation filed a lawsuit against the Company in the United States District Court for the Western District of
Wisconsin for payment of the remaining $1.5 million purchase price and the royalties earned to date. In 2003, the trial court ruled in
favor of CERAbio and ordered us to pay the remaining purchase price and the royalties earned to date. The royalties earned to date
have been recorded within “Accrued expenses and other current liabilities” in the consolidated balance sheet. In 2004, we appealed the
trial court’s judgment to the United States Court of Appeals for the Seventh Circuit. In June 2005, the appeals court upheld the trial
court’s ruling granting CERAbio summary judgment on certain of our counterclaims, but overruled the trial court’s ruling limiting our
evidence that we could present at trial. The effect of this ruling was to grant us a new trial in this dispute, the date for which has been
set as May 8, 2006. We do not believe that the outcome of this lawsuit will have a material adverse effect on our financial position or
results of operations.
Item 4. Submission of Matters to a Vote of Security Holders.
Not applicable.
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Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information
Our common stock is traded on the Nasdaq National Market under the symbol “WMGI.” The following table sets forth, for the
periods indicated, the high and low bid prices per share of our common stock as reported on the Nasdaq National Market.
PART II
Fiscal Year 2005
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
Fiscal Year 2004
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
Holders
High
Low
$ 27.62
$ 27.97
$ 28.40
$ 24.39
$ 35.53
$ 36.99
$ 36.08
$ 30.10
$ 24.00
$ 22.98
$ 23.93
$ 18.30
$ 29.24
$ 29.56
$ 22.90
$ 20.75
As of February 24, 2006, there were 191 stockholders of record and an estimated 7,201 beneficial owners of our common stock.
Dividend Policy
We have never declared or paid cash dividends on our common stock. We currently intend to retain all future earnings for the
operation and expansion of our business. We do not anticipate declaring or paying cash dividends on our common stock in the
foreseeable future. Any payment of cash dividends on our common stock will be at the discretion of our board of directors and will
depend upon our results of operations, earnings, capital requirements, contractual restrictions and other factors deemed relevant by our
board of directors. In addition, our current credit facility prohibits us from paying any cash dividends without the lenders’ consent.
24
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Item 6. Selected Financial Data.
The following tables set forth certain of our selected consolidated financial data as of the dates and for the years indicated. The
selected consolidated financial data as of December 31, 2005, 2004, 2003 and 2002, and for the years then ended, was derived from
our consolidated financial statements audited by KPMG LLP. The selected consolidated financial data as of December 31, 2001, and
for the year then ended, was derived from our consolidated financial statements audited by Arthur Andersen LLP. The audited
consolidated financial statements as of December 31, 2005, 2004 and 2003, and for the years then ended, are included elsewhere in
this filing. The audited consolidated financial statements as of December 31, 2002 and 2001, and for the years then ended, are not
included in this filing. Historical results are not necessarily indicative of the results to be expected for any future period. These tables
are presented in thousands, except per share data.
Statement of Operations:
Net sales
Cost of sales
Gross profit
Operating expenses:
Selling, general and administrative (1)
Research and development
Amortization of intangible assets (2)
Stock-based expense (3)
Acquired in-process research and development
costs
Arbitration settlement award
Total operating expenses
Operating income
Interest (income) expense, net
Other expense (income), net
Income before income taxes
Provision for income taxes
Net income (loss)
Net income (loss) per share: (4)
Basic
Diluted
Weighted-average number of common shares
outstanding - basic
Weighted-average number of common shares
outstanding - diluted
Consolidated Balance Sheet Data:
Cash and cash equivalents
Working capital
Total assets
Long-term liabilities
Stockholders’ equity
2005
2004
Year Ended December 31,
2003
2002
2001
$319,137
91,740
227,397
166,916
22,283
4,250
467
—
—
193,916
33,481
(176)
237
33,420
12,355
$ 21,065
$297,539
84,183
213,356
151,144
18,421
3,889
1,489
—
—
174,943
38,413
1,064
(74)
37,423
13,401
$ 24,022
$248,932
67,815
181,117
127,612
16,151
3,562
2,068
4,558
—
153,951
27,166
1,107
(1,060)
27,119
9,722
$ 17,397
$200,873
55,616
145,257
106,875
10,357
3,946
1,724
—
(4,200)
118,702
26,555
938
(1,277)
26,894
1,834
$ 25,060
$172,921
51,351
121,570
95,556
10,108
5,349
1,996
—
—
113,009
8,561
7,809
685
67
1,574
$ (1,507)
$
$
0.62
0.60
$
$
0.72
0.68
$
$
0.53
0.50
$
$
0.79
0.75
$
$
(0.31)
(0.31)
33,959
33,391
32,857
31,870
13,195
35,199
35,317
34,561
33,550
13,195
2005
2004
As of December 31,
2003
2002
2001
$ 51,277
196,126
371,810
15,547
$292,008
25
$ 83,470
189,803
361,158
19,870
$276,069
$ 66,571
147,255
322,103
20,516
$238,318
$ 51,373
127,557
276,370
25,939
$204,999
$
2,770
47,546
193,719
30,967
$117,300
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Other Data:
Cash flow provided by operating activities
Cash flow used in investing activities
Cash flow (used in) provided by financing
activities
Depreciation
Amortization of intangible assets (2)
Capital expenditures
2005
2004
Year Ended December 31,
2003
2002
2001
$ 5,291
(31,583)
$ 37,365
(18,428)
$ 40,065
(25,844)
$ 21,950
(22,430)
818
$
(15,558)
(5,379)
17,895
4,250
$ 30,356
(2,305)
17,278
3,889
$ 18,316
514
13,948
3,562
$ 18,116
48,384
13,553
3,946
$ 17,974
1,372
10,096
5,349
$ 16,764
(1) In accordance with the provisions of Statement of Financial Accounting Standards (SFAS) No. 145, Rescission of FASB
Statements No. 4, 44, and 64, Amendment of FASB Statement No. 13, and Technical Corrections, our $1.6 million loss on early
retirement of debt in 2001, which was originally presented as an extraordinary loss on debt extinguishment, does not meet the
criteria to be classified as extraordinary. Consequently, pursuant to this newly adopted standard, this amount has been
reclassified to selling, general and administrative expense.
(2) Amortization of intangible assets in 2005, 2004, 2003 and 2002 excludes amortization of goodwill in accordance with SFAS
No. 142, Goodwill and Other Intangible Assets. See Note 6 to the financial statements contained in Item 8 of this report.
(3) Amounts presented as non-cash stock-based expense consist of: cost of sales totaling $12, $68, $107, $108, and $89 for the years
ended December 31, 2005, 2004, 2003, 2002, and 2001, respectively; selling, general and administrative expenses of $449,
$1,364, $1,875, $1,506, and $1,807 for the years ended December 31, 2005, 2004, 2003, 2002, and 2001, respectively; and
research and development expenses of $6, $57, $86, $110, and $100 for the years ended December 31, 2005, 2004, 2003, 2002,
and 2001, respectively.
(4) Net income (loss) applicable to common stockholders includes preferred stock dividends of $2.5 million for the year ended
December 31, 2001.
26
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following management’s discussion and analysis of financial condition and results of operations (MD&A) describes the principal
factors affecting the results of our operations, financial condition, and changes in financial condition, as well as our critical accounting
estimates. MD&A is organized as follows:
• Executive overview. This section provides a general description and history of our business, a brief discussion of our principal
product lines, significant developments in our business, and the opportunities, challenges and risks we focus on in the operation of
our business.
• Net sales and expense components. This section provides a description of the significant line items on our consolidated statement of
operations.
• Results of operations. This section provides our analysis of and outlook for the significant line items on our consolidated statement
of operations.
• Seasonal Nature of Business. This section describes the effects of seasonal fluctuations in our business.
• Liquidity and capital resources. This section provides an analysis of our liquidity and cash flow and a discussion of our outstanding
debt and commitments.
• Critical accounting estimates. This section discusses the accounting estimates that are considered important to our financial
condition and results of operations and require us to exercise subjective or complex judgments in their application. All of our
significant accounting policies, including our critical accounting estimates, are summarized in Note 2 to our consolidated financial
statements in Item 8 of this report.
Executive Overview
Company Description. We are a global orthopaedic medical device company specializing in the design, manufacture and marketing of
reconstructive joint devices and biologics products. Reconstructive joint devices are used to replace knee, hip and other joints that
have deteriorated through disease or injury. Biologics are used to replace damaged or diseased bone, to stimulate bone growth, and to
provide other biological solutions for surgeons and their patients. We have been in business for over 50 years and have built a
well-known and respected brand name and strong relationships with orthopaedic surgeons.
Our corporate headquarters and U.S. operations are located in Arlington, Tennessee, where we conduct our domestic research and
development, manufacturing, warehousing, and administrative activities. Outside the U.S., we have research and development,
manufacturing, and administrative facilities in Toulon, France; research, distribution and administrative facilities in Milan, Italy; and
sales and distribution offices in Canada, Japan and throughout Europe. We market our products in over 60 countries through a global
distribution system that consists of a sales force of approximately 750 individuals who promote our products to orthopaedic surgeons
and hospitals. At the end of 2005, we have approximately 320 exclusive independent distributors and sales associates in the U.S., and
approximately 430 sales representatives internationally who are employed through a combination of our stocking distribution partners
and direct sales offices.
Company History. We were incorporated in November 1999 as a Delaware corporation, and had no operations until December 7,
1999, when we were reorganized by an investment group through the acquisition of our predecessor company, Wright Medical
Technology, Inc. This transaction represented a recapitalization of our predecessor company. On December 22, 1999, we acquired
Cremascoli Ortho Holding, S.A., an orthopaedic medical device company headquartered in Toulon, France. In 2001, we completed
our IPO of 7,500,000 shares of common stock, which generated $84.8 million in net proceeds. In 2002, we completed a secondary
offering of 3,450,000 shares of common stock which generated $49.5 million in net proceeds.
Principal Products. We primarily sell reconstructive joint devices and biologics products. Our reconstructive joint device sales are
derived from three primary product lines: knees and hips, collectively referred to as our reconstructive large joint business, and
extremities. Our biologics sales are derived from a broad portfolio of products designed to stimulate and augment the natural
regenerative capabilities of the human body. We also sell orthopaedic products not considered to be part of our knee, hip, extremity or
biologics product lines.
27
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Our hip joint reconstruction product portfolio provides offerings in the areas of bone-conserving implants, total hip reconstruction,
revision replacement implants, and limb preservation. Our hip joint products include the CONSERVE ® family of products, the
PROFEMUR® Hip System, the LINEAGE® Acetabular System, the ANCA-FIT™ Hip System, and the PERFECTA ® Hip System.
Our biologics products focus on biological musculoskeletal repair and include synthetic and human tissue-based materials. Our
principal biologics products include the GRAFTJACKET® soft tissue repair and containment membranes, the ALLOMATRIX ® line
of injectable tissue-based bone graft substitutes, the OSTEOSET® synthetic bone graft substitute, the MIIG® family of minimally
invasive injectable synthetic bone grafts, and in certain of our international markets, the ADCON® Gel anti-adhesion product.
We offer extremity products for the hand, wrist, elbow, shoulder, foot and ankle in a number of markets worldwide. Our principal
extremity products include the EVOLVE ® Modular Radial Head device, the CHARLOTTE™ Foot and Ankle System, the
LOCON-T® and LOCON™ VLS Distal Radius Plating Systems, and the MICRONAIL™ intramedullary wrist fracture repair system.
We also sell the Swanson™ line of finger and toe joint replacement products and the ORTHOSPHERE ® Carpometacarpal Implant for
repair of the basal thumb joint.
Our knee reconstruction products position us well in the areas of total knee reconstruction, revision replacement implants, and limb
preservation products. Our principal knee products include the ADVANCE ® Knee System and the ADVANCE ® Unicompartmental
Knee System.
Significant Business Developments. Net sales grew 7.3% in 2005, totaling $319.1 million, compared to $297.5 million in 2004. Our
success is attributable to our focus on the high growth sectors of the orthopaedic industry, such as advanced bearing surfaces, modular
necks and bone conserving implants within the hip market. Our hip, knee and extremity product lines contributed significantly to our
performance in 2005, achieving 10%, 8%, and 11% growth rates, respectively.
During 2005, our domestic biologics business declined by approximately 2% year-over-year. This decline was driven by the continued
downward trend in sales of our DBM containing ALLOMATRIX ® family of products due to competitive pressures in the mature
market for DBM containing products. We anticipate that domestic sales of these products will continue to decline in 2006; however,
we expect that these declines will be offset by sales growth of our GRAFTJACKET® soft tissue repair and containment membranes.
During 2005, our international sales increased by approximately 4% as compared to 2004. This slower rate of growth is attributable to
our markets in France and Italy, both of which declined year-over-year. These declines began in the fourth quarter of 2004 as a result
of the transition of certain management and distribution personnel in Southern Europe. We anticipate that sales in France and Italy
will continue to decline year-over-year in the first half of 2006. However, we believe that sales in these markets will grow in the latter
half of 2006 as the personnel now in place successfully complete this transitional period. Sales in our other international markets
increased by 17% in total during 2005 as compared to prior year.
In mid-February 2005, we launched our internally-developed CHARLOTTE™ Foot and Ankle System and transitioned our foot and
ankle business from a line of products supplied by a third party vendor pursuant to a distribution agreement that expired in the first
quarter of 2005. The CHARLOTTE™ Foot and Ankle System offers a complete range of options for the most common foot and ankle
surgical needs and includes six products that feature advanced design elements for simplicity, versatility, and high performance.
During the fourth quarter of 2004, we incurred approximately $2.9 million of costs as a result of this transition to write down our
distributed foot and ankle implant inventory to its estimated net realizable value and accelerated depreciation on the related surgical
instrumentation. The success of our CHARLOTTE™ Foot and Ankle system contributed significantly to the success of our extremity
product line in 2005.
In June 2005, our premarket approval (PMA) application with the United States Food and Drug Administration (FDA) for our
ADCON® Gel product was withdrawn by management. Based on the progress of the review to date, management determined that in
order to adequately address all of the requests made by the FDA in connection with their review of this application, withdrawal of the
filing at this time was appropriate. Management is evaluating whether to continue to pursue re-submission for this product. If
re-submitted, there can be no assurance that the FDA will accept another submission for filing in a timely manner or at all.
28
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
In November 2005, we received marketing clearance from the FDA for our IGNITE® Bone Void Filler kits. This clearance was
obtained based on satisfaction of the FDA’s requirements pursuant to a 510(k) premarket notification process that began with our
submission of a 510(k). This submission was in response to the FDA’s clarification to all known manufacturers of DBM-containing
products including us, that such products should be regulated under the medical device premarket notification provisions of the Food,
Drug, and Cosmetic Act. As of December 31, 2005, all of the Company’s DBM-containing products currently produced and sold in
the U.S. have received regulatory clearance.
Significant Industry Factors. Our industry is impacted by numerous competitive, regulatory and other significant factors. The growth
of our business relies on our ability to continue to develop new products and innovative technologies, obtain regulatory clearance and
compliance for our products, protect the proprietary technology of our products and our manufacturing processes, manufacture our
products cost-effectively, respond to competitive pressures specific to each of our geographic markets, including our ability to enforce
non-compete agreements, and successfully market and distribute our products in a profitable manner. We, and the entire industry, are
subject to extensive governmental regulation, primarily by the FDA. Failure to comply with regulatory requirements could have a
material adverse effect on our business. Additionally, our industry is highly competitive and has recently experienced increased
pricing pressures, specifically in the areas of reconstructive joints and biologic bone repair products. We devote significant resources
to assessing and analyzing competitive, regulatory and economic risks and opportunities. A detailed discussion of these and other
factors is provided in Item 1A of this report.
Net Sales and Expense Components
Net sales. We derive our net sales primarily from the sale of reconstructive joint devices and biologics products. An overview of our
principal product lines is provided in “Executive Overview.”
Cost of sales. Our cost of sales consists primarily of direct labor, allocated manufacturing overhead, raw materials and components,
charges incurred for excess and obsolete inventories, royalty expenses associated with licensing technologies used in our products or
processes, and certain other period expenses.
Selling, general and administrative. Our selling, general and administrative expenses consist primarily of salaries, sales commissions,
royalty and consulting expenses associated with our medical advisors, marketing costs, facility costs, legal costs, other general
business and administrative expenses, and depreciation expense associated with surgical instruments required by surgeons to use when
implanting our products.
Research and development. Research and development expense includes costs associated with the design, development, testing,
deployment, enhancement and regulatory approval of our products.
Amortization of intangible assets. Our intangible assets consist of purchased intangibles related to completed technology, distribution
channels and trademarks primarily resulting from our 1999 acquisition of Cremascoli, as well as distribution and product licenses, and
non-compete agreements. We amortize intangible assets over periods ranging from 1 to 15 years.
Stock-based expense. We incur non-cash stock-based expenses as a result of the amortization of non-cash deferred compensation that
is recorded in accordance with Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees. This
deferred compensation resulted following the issuance of stock options to employees and the sale of equity securities prior to the
completion of our IPO when the estimated fair value of the securities was deemed, for financial reporting purposes, to have exceeded
their respective exercise or sales price. Additionally, for stock-based incentives granted to consultants, we defer and amortize the fair
value of such grants
29
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
as calculated pursuant to Statement of Financial Accounting Standards (SFAS) No. 123, Accounting for Stock-Based Compensation.
Deferred compensation is amortized on a straight-line basis over the respective vesting periods of the stock-based incentives, which is
generally four years, and we immediately expense all non-cash stock-based compensation associated with the issuance of equity where
no vesting restrictions apply.
In December 2004, the FASB issued SFAS No. 123 (Revised 2004), Share Based Payment (SFAS No. 123R), which requires the
recognition of compensation expense for the fair value of share-based transactions. The fair value must be determined as of the date of
grant using a valuation model such as Black-Scholes or a lattice model. The resulting compensation will be recognized over the
service period. In April 2005, the SEC amended Rule 4-01(a) of Regulation S-X regarding the compliance date for SFAS No. 123R.
This amendment modified the effective date of SFAS No. 123R, requiring adoption of this standard on the first interim or annual
reporting period of the first fiscal year beginning on or after June 15, 2005. Accordingly, we adopted SFAS No. 123R effective
January 1, 2006. Although management’s evaluation of SFAS No. 123R is not complete, we estimate that the amount of non-cash
stock-based compensation that we will record in 2006 pursuant to the adoption of SFAS No. 123R will be significant. The effect on
our historical results of operations of expensing the fair value of stock options using the Black-Scholes model and the provisions of
SFAS No. 123 is presented in Note 2 to our consolidated financial statements in Item 8 of this report.
Interest (income) expense, net. Interest (income) expense, net, consists primarily of interest on borrowings outstanding under our
senior credit facility, capital lease agreements, and certain of our factoring agreements, as well as non-cash expenses associated with
the amortization of deferred financing costs resulting from the origination of our senior credit facility. These expenses are offset by
income generated by our invested cash balances and investments in marketable securities.
Provision for income taxes. We record provisions for income taxes on earnings generated by both our domestic and international
operations. Historically, our effective tax rates have varied from our statutory tax rates primarily due to research and development
credits and changes in estimates related to our valuation allowances recorded against our net deferred tax assets.
30
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Results of Operations
Comparison of the year ended December 31, 2005 to the year ended December 31, 2004
The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts (in thousands) and as
percentages of net sales:
Net sales
Cost of sales
Gross profit
Operating expenses:
Selling, general and administrative
Research and development
Amortization of intangible assets
Stock-based expense
Total operating expenses
Operating income
Interest (income) expense, net
Other expense (income), net
Income before income taxes
Provision for income taxes
Net income
Year Ended December 31,
2005
2004
Amount
$319,137
91,740
227,397
166,916
22,283
4,250
467
193,916
33,481
(176)
237
33,420
12,355
$ 21,065
% of
Sales
100.0%
28.7%
71.3%
52.3%
7.0%
1.3%
0.1%
60.8%
Amount
$297,539
84,183
213,356
151,144
18,421
3,889
1,489
174,943
10.5%
38,413
(0.1)%
0.1%
10.5%
3.9%
6.6%
1,064
(74)
37,423
13,401
$ 24,022
The following table sets forth our net sales by product line for the periods indicated (in thousands) and the percentage of
year-over-year change:
Hip products
Knee products
Biologics products
Extremity products
Other
Total net sales
Year
Ended
December
31,
2005
$109,267
94,073
62,358
40,594
12,845
$319,137
Year
Ended
December
31,
2004
$ 99,133
87,408
62,070
36,433
12,495
$297,539
31
% of
Sales
100.0%
28.3%
71.7%
50.8%
6.2%
1.3%
0.5%
58.8%
12.9%
0.4%
0.0%
12.6%
4.5%
8.1%
%
Change
10.2%
7.6%
0.5%
11.4%
2.8%
7.3%
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
The following graphs illustrate our product line sales as a percentage of total net sales for the years ended December 31, 2005 and
2004:
2005
2004
Net sales. Our net sales growth in 2005 was primarily attributable to the success of our domestic reconstructive joint business, as our
domestic hip, extremity and knee product lines grew by 18%, 12%, and 11%, respectively. Domestic net sales totaled $197.5 million
in 2005 and $180.4 million in 2004, representing approximately 62% and 61% of total net sales in 2005 and 2004, respectively, and
growth of 10%. International net sales totaled $121.6 million in 2005, a 4% increase as compared to net sales of $117.2 million in
2004. This increase in international sales is attributable to continued growth in our Asian markets, which was partially offset by
declines in our Italian and French markets due to the transition of management and distribution personnel in Southern Europe.
Our hip product sales totaled $109.3 million in 2005, representing a 10% increase. Growth in our hip business in 2005 was primarily
driven by our domestic markets, where total hip unit sales grew 13% as compared to 2004, reflecting the success of our CONSERVE ®
Total Implant with BFH™ Technology and our PROFEMUR ® line of primary stems featuring our innovative neck modularity.
Additionally, we have continued to note favorable shifts in our sales mix to premium priced hard bearing procedures, which include
our ceramic-on-ceramic and metal-on-metal products, which further contributed to our domestic growth. In our international markets,
hips sales increased by 2% to $52.0 million, as increased sales, primarily in Japan, were mostly offset by declines in Italy.
Our extremity product sales increased to $40.6 million in 2005, representing growth of 11% over 2004, which is mainly attributable to
increased unit sales of our EVOLVE ® Modular Radial Head System and the successful mid-February 2005 launch of our
CHARLOTTE™ Foot and Ankle system. Further contributing to our year-over-year growth were increased unit sales of our
MICRONAIL™ intramedullary wrist fracture repair system and our LOCON-T® and LOCON™ VLS Distal Radius Plating Systems.
Sales of our knee products totaled $94.1 million in 2005, representing growth of 8% as compared to 2004. This increase was primarily
driven by increased unit sales of our ADVANCE ® knee systems due to enhanced minimally invasive surgery (MIS) instrumentation
and broader acceptance of our ADVANCE ® Double-High tibial insert. International knee sales growth in Asia and certain European
markets was partially offset by declines in France and Italy.
Sales of our biologics products in 2005 totaled $62.4 million, and were relatively flat compared to prior year. The continued growth of
our GRAFTJACKET® soft tissue repair and containment membranes in the U.S., as well as increased sales in Asia, were offset by
declines of our DBM containing products in our domestic markets.
As we look ahead in 2006, we anticipate continued growth within our reconstructive joint business. In our knee business, we look
forward to continuing success as our minimally invasive surgical instrumentation continues to gain acceptance in the U.S. In our hip
business, we anticipate that the strength of our hip product portfolio, which consists of our innovative bone-conserving implants,
advanced bearing surfaces and modular neck technology, will lead to continued success in the market. Our extremity business should
continue to strengthen, driven mostly by our CHARLOTTE™ foot and ankle system, our EVOLVE ® Modular Radial Head system
and our wrist fracture repair products. Within biologics, we expect sales of our GRAFTJACKET® tissue repair and containment
membranes to continue to expand.
32
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Cost of sales. In 2005, our cost of sales as a percentage of net sales increased to 28.7% as compared to 28.3% in 2004. Cost of sales in
2005 included charges of approximately $1.5 million to write down inventory to its net realizable value due to the termination of an
agreement to distribute certain third party spinal products in Europe. Cost of sales in 2004 included charges of approximately
$2.4 million to write down certain foot and ankle inventory to its net realizable value as a result of the transition to our
CHARLOTTE™ foot and ankle system. The increase in cost of sales as a percentage of net sales is attributable to increased levels of
fixed manufacturing costs and distribution costs, as well as shifts in our product line sales. Our cost of sales and corresponding gross
profit percentages can be expected to fluctuate in future periods depending upon changes in our product sales mix and prices,
distribution channels and geographies, manufacturing yields, period expenses and levels of production volume.
Selling, general and administrative. Our selling, general and administrative expenses as a percentage of net sales totaled 52.3% in
2005, a 1.5 percentage point increase from 50.8% in 2004. This increase is primarily attributable to severance charges of
approximately $1.6 million incurred during 2005 related to the transition of management in our U.S. and European operations, charges
of approximately $1.5 million related to a European distributor transition and the related legal dispute, increased investments in sales
and marketing initiatives, and higher levels of legal fees. These increases were partially offset by the favorable resolution in the
second quarter of 2005 of two liabilities assumed as part of our December 1999 acquisition of Cremascoli, lower expenses related to
compliance with Section 404 of the Sarbanes-Oxley Act of 2002, reduced insurance costs, and the 2004 expenses related to our
limited market withdrawal of certain CONSERVE® hip components and our foot and ankle product line transition.
We anticipate that our selling, general and administrative expenses will increase in absolute dollars to the extent that any additional
growth in net sales results in increases in sales commissions and royalty expense associated with those sales and requires us to expand
our infrastructure. Further, in the near term, we anticipate that these expenses will increase as a percentage of net sales as we make
strategic investments in order to grow our business, and as we record non-cash stock-based compensation pursuant to SFAS No. 123R.
Research and development. Our investment in research and development activities represented approximately 7.0% of net sales in
2005, as compared to 6.2% in 2004. The increase was driven by elevated levels of investments in product development initiatives and
increases in clinical and regulatory spending. Our key product launches in 2005 included our CHARLOTTE™ Foot and Ankle System
and our CONSERVE® BFH Advance Metal.
For 2006, we anticipate that our research and development expenditures will increase as a percentage of net sales and in absolute
dollars as we continue to increase our investment in product development initiatives and clinical studies to support regulatory
approvals and provide expanded proof of the efficacy of our products, and as we record non-cash stock-based compensation pursuant
to SFAS No. 123R.
Amortization of intangible assets. Non-cash charges associated with amortization of intangible assets totaled $4.3 million in 2005
versus $3.9 million in 2004. Based on the intangible assets held at December 31, 2005, we expect to amortize approximately
$4.0 million in 2006, $3.0 million in 2007, $2.7 million in 2008, $2.4 million in 2009 and $350,000 in 2010.
Stock-based expense. We recognized $467,000 and $1.5 million of non-cash stock-based expense during 2005 and 2004, respectively.
This decrease is due to lower levels of amortization of deferred compensation related to options issued prior to our initial public
offering in 2001.
Interest (income) expense, net. Interest (income) expense, net, consists of interest expense of approximately $1.9 million during both
2005 and 2004, primarily from borrowings under our senior credit facility, capital lease agreements, and certain of our factoring
agreements, offset by interest income of approximately $2.0 million and $850,000 during 2005 and 2004, respectively, generated by
our invested cash balances and investments in marketable securities. The increase in interest income is attributable to our investments
in marketable securities during 2005. These investments are discussed further in Note 2 to our consolidated financial statements in
Item 8 of this report.
33
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Provision for income taxes. We recorded tax provisions of $12.4 million and $13.4 million in 2005 and 2004, respectively. Our
effective tax rate for 2005 and 2004 was approximately 37% and 36%, respectively, which reflects the impact of research and
development credits, changes in estimates related to the valuation allowances recorded against our deferred tax assets and, in 2005, the
impact of the domestic manufacturers’ deduction included within the American Jobs Creation Act of 2004.
We expect our 2006 effective tax rate to be significantly higher than our historical effective tax rates as a result of the expense we will
be required to record under the provisions of SFAS 123R. A significant portion of the non-cash stock-based compensation that we will
recognize may not be deductible under U.S. and foreign tax regulations. We cannot reasonably estimate our overall effective tax rate
for 2006, as we are unable to reasonably estimate the amount of future stock option grants and the related expense that will ultimately
be deductible for tax purposes.
Comparison of the year ended December 31, 2004 to the year ended December 31, 2003
The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts (in thousands) and as
percentages of net sales:
Net sales
Cost of sales
Gross profit
Operating expenses:
Selling, general and administrative
Research and development
Amortization of intangible assets
Stock-based expense
Acquired in-process research and development costs
Total operating expenses
Operating income
Interest expense, net
Other income, net
Income before income taxes
Provision for income taxes
Net income
Year Ended December 31,
2004
2003
Amount
$297,539
84,183
213,356
151,144
18,421
3,889
1,489
—
174,943
% of
Sales
100.0%
28.3%
71.7%
50.8%
6.2%
1.3%
0.5%
—
58.8%
Amount
$248,932
67,815
181,117
127,612
16,151
3,562
2,068
4,558
153,951
38,413
12.9%
27,166
1,064
(74)
37,423
13,401
$ 24,022
0.4%
0.0%
12.6%
4.5%
8.1%
1,107
(1,060)
27,119
9,722
$ 17,397
The following table sets forth our net sales by product line for the periods indicated (in thousands) and the percentage of
year-over-year change:
Hip products
Knee products
Biologics products
Extremity products
Other
Total net sales
Year
Ended
December
31,
2004
$ 99,133
87,408
62,070
36,433
12,495
$297,539
Year
Ended
December
31,
2003
$ 78,071
78,338
50,056
31,876
10,591
$248,932
34
% of
Sales
100.0%
27.2%
72.8%
51.3%
6.5%
1.4%
0.8%
1.8%
61.8%
10.9%
0.4%
(0.4)%
10.9%
3.9%
7.0%
%
Change
27.0%
11.6%
24.0%
14.3%
18.0%
19.5%
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
The following graphs illustrate our product line sales as a percentage of total net sales for the years ended December 31, 2004 and
2003:
2004
2003
Net sales. Net sales growth in 2004 was attributable to increased sales across all of our principal product lines, with significant
contributions from hips and biologics which grew by 27% and 24%, respectively, and solid growth in our extremity and knee business
which grew by 14% and 12%, respectively. Geographically, our domestic net sales totaled $180.4 million in 2004 and $152.9 million
in 2003, representing approximately 61% of total net sales in both years and growth of 18%. Our international net sales totaled
$117.2 million in 2004, a 22% increase as compared to net sales of $96.1 million in 2003. Our 2004 international net sales included a
favorable currency impact of approximately $8.1 million when compared to 2003 net sales, principally resulting from the 2004
performance of the euro against the U.S. dollar. Our international growth was primarily driven by increased sales in our European and
Asian markets, with expansion across all product lines.
From a product line perspective, our net sales growth for 2004 was attributable to increases in sales across all of our principal product
lines. For 2004, we experienced growth of 27%, 24%, 14% and 12%, in our hip, biologics, extremity, and knee product lines,
respectively. Our most significant growth drivers in 2004 were our hip and biologics product lines. During 2004, our 27% hip sales
growth was attributable primarily to success in domestic markets, specifically driven by our CONSERVE® Total Implant with BFH™
Technology and our PROFEMUR® line of primary stems featuring our innovative neck modularity. In our international markets, unit
sales growth of our CONSERVE® Plus Resurfacing Implant and a favorable currency impact of $4 million both impacted the year
over year sales increase. The growth of our biologics business in 2004 was primarily attributable to the continued favorable
performance, in domestic markets, of our GRAFTJACKET® soft tissue repair and containment membranes combined with the
performance of our ADCON® Gel product in international markets.
Cost of sales. Cost of sales as a percentage of net sales increased to 28.3% in 2004 from 27.2% in 2003. Approximately 0.8 percentage
points of this increase was attributable to $2.4 million of costs incurred during the fourth quarter of 2004 to write down certain foot
and ankle implant inventory to its net realizable value as a result of the transition of this product line to our CHARLOTTE™ Foot and
Ankle System. The remaining increase as a percentage of sales was primarily attributable to higher levels of charges incurred for
excess and obsolete inventories.
Operating expenses. Our total operating expenses decreased, as a percentage of net sales, by 3 percentage points to 58.8% in 2004.
Operating expenses include selling, general and administrative expenses, research and development expenses, amortization of
intangibles, stock-based expenses and, in 2003, acquired in-process research and development costs. The decrease in operating
expenses was primarily driven by the 2003 charge of $4.6 million for in-process research and development. Further, our selling,
general and administrative expenses as a percentage of net sales decreased by 0.5 percentage points, driven by lower royalty and
commission expenses as a percentage of sales due to shifts in our geographic sales mix, which were partially offset by incremental
corporate governance costs as well as charges associated with our limited market withdrawal of certain CONSERVE ® hip components
and our foot and ankle product line transition. Lower levels of stock-based expense also contributed to our year-over-year decrease in
operating expenses as a percentage of net sales.
35
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
In-process research and development cost. Upon consummation of our acquisition of certain ADCON® Gel technology assets from
Gliatech Inc. in March 2003, we immediately recognized as expense approximately $4.6 million in costs representing the estimated
fair value of acquired in-process research and development (IPRD) that had not yet reached technological feasibility and had no
alternative future use. See Note 3 to our consolidated financial statements in Item 8 of this report.
We engaged an independent third party to conduct a valuation of the intangible assets acquired. The value was determined by
estimating the costs to develop the acquired IPRD into commercially viable products, estimating the resulting net cash flows from this
project, and discounting the net cash flows back to their present values. An additional discount was applied to take into account the
uncertainty surrounding the successful development and commercialization of the acquired IPRD. The resulting net cash flows from
the project were based on management’s best estimates of revenue, cost of sales, research and development costs, selling, general and
administrative costs, and income taxes from the project. A summary of the estimates used to calculate the net cash flows for the
project is as follows:
Year net cash
in-flows
expected to
Discount rate
including
factor to
account for
uncertainty of
success
32.3%
begin
2004
Project
ADCON® Gel
ADCON® Gel products are designed to reduce adhesion formation following lumbar spine (ADCON®-L Gel) and peripheral
tendon/nerve (ADCON®-T/N Gel) procedures, thus reducing or eliminating post-operative pain. Both ADCON®-L Gel and
ADCON®-T/N Gel are commercially available internationally, but are currently not available for sale in the U.S. ADCON ®-L Gel had
previously received regulatory clearance from the FDA in 1998. In 2000, the FDA determined that the provisions of its Application
Integrity Policy (AIP) would be applied to Gliatech due to violations of Good Clinical Practices in the conduct, analysis, and reporting
of data specific to the U.S. Clinical Study of ADCON®-L Gel. In 2003, the FDA lifted the AIP status of Gliatech, which subsequently
allowed us, as the new owner of the technology, to present the FDA with clinical data intended to support the return of ADCON ®-L
Gel to the U.S. market. However, in 2005, our PMA application with the FDA for our ADCON ® Gel product was withdrawn by
management. Management is considering whether to continue to pursue re-submission for this product. If re-submitted, there can be
no assurance that the FDA will accept another submission for filing in a timely manner or at all.
Acquired IPRD
$4,558,000
We may use portions of our existing cash to continue to develop the acquired IPRD into commercially viable products. This
development would consist primarily of the completion of all clinical evaluation testing activities and regulatory approvals that are
necessary to establish the safety and efficacy of the products and to market them in the U.S. Bringing the acquired IPRD to market
could also include testing the products for compatibility and interoperability with commercially viable products. Due to the history of
the ADCON® Gel products with the FDA, we are unable to estimate the extent of research and development activities that will be
necessary to develop these products into commercially viable products.
Provision for income taxes. Our effective tax rate for both 2004 and 2003 was approximately 36%, which reflects the impact of
research and development credits and changes in estimates related to the valuation allowances recorded against our deferred tax assets.
Seasonal Nature of Business
We traditionally experience lower sales volumes in the third quarter months than throughout the rest of the year as a result of the
European holiday schedule. In addition, our first quarter selling, general and administrative expenses include additional expenses that
we incur in connection with the annual meeting held by the American Academy of Orthopaedic Surgeons. This meeting, which is the
largest orthopaedic meeting in the world, features the presentation of scientific papers and instructional courses for orthopaedic
surgeons. During this 3-day event, we display our most recent and innovative products for these surgeons.
36
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Liquidity and Capital Resources
The following table sets forth, for the periods indicated, certain liquidity measures (in thousands):
Cash and cash equivalents
Short-term marketable securities
Working capital
Line of credit availability
As of December 31,
2005
$ 51,277
25,000
196,126
59,878
2004
$ 83,470
—
189,803
59,708
During 2005, we invested $25 million of our excess cash balance in short-term marketable debt securities in order to increase our rate
of return, resulting in a decrease in our cash and cash equivalents. Specifically, our investments in marketable securities at
December 31, 2005, are available for redemption through an auction process every 21 or 49 days from initial purchase. While these
investments are not considered cash equivalents for financial reporting purposes, due to the short-term nature of these investments, we
do not believe that these investments will have an impact on our overall liquidity position.
Operating Activities. Cash provided by operating activities totaled $5.3 million in the 2005, as compared to $37.4 million in 2004 and
$40.1 million in 2003. The decrease in cash provided by operating activities in 2005 is primarily attributable to $25 million of cash
invested in marketable securities and increased payments for estimated income taxes of approximately $8.8 million. Cash provided by
operating activities in 2004 benefited from the profitability of our business and working capital management, which resulted primarily
from improved collection of our outstanding receivables during 2004, which was offset by increased investments in new product
inventory in order to prepare for anticipated product launches, as well as an increase of approximately $3.9 million for estimated tax
payments.
Investing Activities. Our capital expenditures totaled approximately $30.4 million in 2005, $18.3 million in 2004, and $18.1 million in
2003. The increase in 2005 is primarily related to investments in minimally invasive surgical instrumentation for our hip and knee
businesses. Our industry is capital intensive, particularly as it relates to surgical instrumentation. Historically, our capital expenditures
have consisted of purchased manufacturing equipment, research and testing equipment, computer systems, office furniture and
equipment, and surgical instruments. We expect to incur capital expenditures of approximately $30 million in total for 2006 for
routine capital expenditures.
In 2003, in addition to our routine capital expenditures, we paid $7.8 million to complete the purchase of IPRD, tangible assets, and
intangible assets from Gliatech, which were primarily related to the ADCON® Gel technology. We are continuously evaluating
opportunities to purchase technology and other forms of intellectual property and are, therefore, unable to predict the timing of future
purchases.
Financing Activities. During 2005, we made $5.0 million in scheduled payments related to borrowings under our senior credit facility
and approximately $2.1 million in payments related to our long-term capital leases. These payments were offset by proceeds of
$2.9 million from the issuance of common stock under our stock-based compensation plans. In addition, our operating subsidiary in
Italy continues to factor portions of its accounts receivable balances under factoring agreements, which are considered financing
transactions for financial reporting purposes. The cash proceeds received from these factoring agreements, net of the amount of
factored receivables collected, are reflected as cash flows from financing activities in our consolidated statements of cash flows. The
proceeds received under these agreements in 2005, 2004, and 2003 totaled approximately $8.0 million, $10.7 million, and
$4.7 million, respectively. These proceeds were offset by payments for factored receivables collected of approximately $9.2 million
and $10.8 million in 2005 and 2004, respectively. We recorded obligations of $3.5 million and $5.2 million for the amount of
receivables factored under these agreements as of December 31, 2005 and 2004, respectively, which are included within “Accrued
expenses and other current liabilities” in our consolidated balance sheet.
In 2006, our debt payments will total $3.8 million based on the terms of our senior credit facility. Additionally, we will make
continued payments under our long-term capital leases, including interest, of approximately $2.0 million in 2006. We anticipate that
our factoring program in Italy will continue; however, the level and extent of the amounts factored under the agreement and the
ultimate amount of proceeds received under the program cannot be predicted.
37
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Therefore, we are unable to predict the ultimate amount of proceeds that will be received in 2006 related to these factoring
agreements.
Contractual Cash Obligations. At December 31, 2005, we had contractual cash obligations and commercial commitments as follows
(in thousands):
Amounts reflected in balance sheet:
Notes payable
Capital lease obligations (1)
Amounts not reflected in balance sheet:
Operating leases
Purchase obligations
Royalty and consulting agreements
Total contractual cash obligations
Total
2006
2007-2008
2009-
2010
After
2010
Payments Due by Periods
$ 3,750
3,858
$ 3,750
2,008
$ —
1,578
$ —
266
$ —
6
14,407
5,160
6,317
$33,492
6,167
5,160
3,369
$20,454
6,492
—
861
$ 8,931
986
—
760
$ 2,012
762
—
1,327
$ 2,095
(1) Payments include amounts representing interest
Our senior credit facility, which we entered into in August 2001, has a five-year term and consists of $20 million in term loans, with
an unpaid balance of approximately $3.8 million at December 31, 2005, and a revolving loan facility of up to $60 million. Borrowings
under the senior credit facility are guaranteed by all of our subsidiaries and are collateralized by all of the assets of Wright Medical
Technology, Inc., our wholly-owned subsidiary. The credit facility contains customary covenants including, among other things,
restrictions on our ability to pay cash dividends, prepay debt, incur additional debt and sell assets. The credit facility also requires us
to maintain certain financial covenants, including a specified consolidated leverage (or debt-to-equity) ratio and a specified
consolidated fixed charge coverage ratio. In the event that we violate any covenants, we could be required to repay the remaining
balance of the debt. Additionally, should we be required to repay the loan before its scheduled maturity, we would incur a charge to
operating income for unamortized financing costs. At our option, borrowings under the credit facility bear interest either at a rate equal
to a fixed base rate plus a spread of 0.75% to 1.25% or at a rate equal to an adjusted LIBOR plus a spread of 1.75% to 2.25%,
depending on our consolidated leverage ratio, with a current annual rate of 5.7%.
The amounts reflected in the table above for capital lease obligations represent future minimum lease payments under our capital lease
agreements which are primarily for certain property and equipment. The present value of the minimum lease payments are recorded in
our balance sheet at December 31, 2005. The minimum lease payments related to these leases are discussed further in Note 8 to our
consolidated financial statements contained in Item 8 of this report.
The amounts reflected in the table above for operating leases represent future minimum lease payments under noncancellable
operating leases primarily for certain equipment and office space. Portions of these payments are denominated in foreign currencies
and were translated in the table above based on their respective U.S. dollar exchange rates at December 31, 2005. These future
payments are subject to foreign currency exchange rate risk. In accordance with accounting principles generally accepted in the U.S.,
our operating leases are not recognized in our consolidated balance sheet; however, the minimum lease payments related to these
agreements are disclosed in Note 15 to our consolidated financial statements contained in Item 8 of this report.
Our purchase obligations reflected in the table above consist of minimum purchase obligations related to certain supply agreements.
The royalty and consulting agreements in the above table represent minimum payments to consultants that are contingent upon future
services. Portions of these payments are denominated in foreign currencies and were translated in the table above based on their
respective U.S. dollar exchange rates at December 31, 2005. These future payments are subject to foreign currency exchange rate risk.
Our purchase obligations and royalty and consulting agreements are disclosed in Note 15 to our consolidated financial statements
contained in Item 8 of this report.
38
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
In addition to the contractual cash obligations discussed above, all of our domestic sales and a portion of our international sales are
subject to commissions based on net sales, and a substantial portion of our global sales are subject to other royalties earned based on
product sales. Further, under our factoring agreement in Italy, our liability for cash proceeds received of $3.5 million discussed in
“Financing Activities” may be subject to repayment upon 15 days notice. None of these amounts are included in the table above.
Other Liquidity Information. We have funded our cash needs since 2000 through various equity and debt issuances and through cash
flow from operations. In 2001, we completed our IPO of 7,500,000 shares of common stock which generated $84.8 million in net
proceeds. In 2002, we completed a secondary offering of 3,450,000 shares of common stock which generated $49.5 million in net
proceeds.
In 2006, our senior credit facility will expire and it is our current intent to replace this credit facility with a new facility including a
credit line equal to or greater than our current $60 million credit line. There can be no assurance that we will ultimately be able to
replace our current credit facility with a new facility which includes a credit line of this level.
Although it is difficult for us to predict our future liquidity requirements, we believe that our current cash balance of approximately
$51.3 million, our marketable securities balance of $25.0 million, and our expected cash flow from our 2006 operations will be
sufficient for the foreseeable future to fund our working capital requirements and operations, permit anticipated capital expenditures in
2006 of approximately $30 million, meet our contractual cash obligations in 2006, and fund any potential expansion of our current
facilities or the construction of new facilities.
Critical Accounting Estimates
All of our significant accounting policies and estimates are described in Note 2 to our consolidated financial statements contained in
Item 8 of this report. However, certain of our more critical accounting estimates require the application of significant judgment by
management in selecting the appropriate assumptions in determining the estimate. By their nature, these judgments are subject to an
inherent degree of uncertainty. We develop these judgments based on our historical experience, terms of existing contracts, our
observance of trends in the industry, information provided by our customers, and information available from other outside sources, as
appropriate. Different, reasonable estimates could have been used in the current period. Additionally, changes in accounting estimates
are reasonably likely to occur from period to period. Both of these factors could have a material impact on the presentation of our
financial condition, changes in financial condition or results of operations.
We believe that the following financial estimates are both important to the portrayal of our financial condition and results of
operations and require subjective or complex judgments. Further, we believe that the items discussed below are properly recorded in
the financial statements for all periods presented. Our management has discussed the development, selection, and disclosure of our
most critical financial estimates with the audit committee of our Board of Directors and with our independent auditors. The judgments
about those financial estimates are based on information available as of the date of the financial statements. Those financial estimates
include:
Revenue recognition. Our revenues are generated through two types of customers, hospitals and stocking distributors, with the
majority of our revenue derived from sales to hospitals. Our products are sold through a network of independent sales representatives
in the U.S. and by a combination of employee sales representatives, independent sales representatives, and stocking distributors
outside the U.S. We record revenues from sales to hospitals when the hospital takes title to the product, which is when the product is
surgically implanted in a patient and a purchase order is received from the hospital. We view the receipt of a purchase order as the
evidence of customer acceptance of the product.
We record revenues from sales to our stocking distributors at the time the product is shipped to the distributor. Our stocking
distributors, who sell the products to their customers, take title to the products and assume all risks of ownership. Our distributors are
obligated to pay us within specified terms regardless of when, if ever, they sell the products. In general, our distributors do not have
any rights of return or exchange; however, in limited situations we have repurchase agreements with certain stocking distributors.
Those certain agreements require us to repurchase a specified percentage of the inventory purchased by the distributor within a
specified period of time prior to the expiration of the contract. During those specified periods, we defer the applicable percentage of
the sales.
39
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Approximately $170,000 and $90,000 of deferred revenue related to these types of agreements was recorded at December 31, 2005
and 2004, respectively.
We must make estimates of potential future product returns related to current period product revenue. To do so, we analyze our
historical experience related to product returns when evaluating the adequacy of the allowance for sales returns. Judgment must be
used and estimates made in connection with establishing the allowance for product returns in any accounting period. Our allowances
for product returns of approximately $430,000 and $400,000 are included as a reduction of accounts receivable at December 31, 2005
and 2004, respectively. Should actual future returns vary significantly from our historical averages, our operating results could be
affected.
Allowances for doubtful accounts. We experience some credit loss on our accounts receivable and accordingly we must make
estimates related to the ultimate collection of our accounts receivable. Specifically, we analyze our accounts receivable, historical bad
debt experience, customer concentrations, customer creditworthiness, and current economic trends when evaluating the adequacy of
our allowance for doubtful accounts.
The majority of the Company’s receivables are from hospitals, many of which are government funded. Accordingly, the Company’s
collection history with this class of customer has been favorable. Historically, the Company has experienced minimal bad debts from
its hospital customers and more significant bad debts from certain international distributors, typically as a result of specific financial
difficulty or geo-political factors. The Company writes off receivables when it determines that the receivables are uncollectible,
typically upon customer bankruptcy or the customer’s non-response to collection efforts.
We believe that the amount included in our allowance for doubtful accounts has been a historically accurate estimate of the amount of
accounts receivable that are ultimately collected. While we believe that our allowance for doubtful accounts is adequate, the financial
condition of our customers and the geo-political factors that impact reimbursement under individual countries’ healthcare systems can
change rapidly and as such, additional allowances may be required in future periods. Our accounts receivable balance for both 2005
and 2004 was $61.7 million, net of allowances for doubtful accounts of $2.0 million and $1.8 million, at December 31, 2005 and
2004, respectively.
Excess and obsolete inventories. We value our inventory at the lower of the actual cost to purchase and/or manufacture the inventory
or its net realizable value. We regularly review inventory quantities on hand for excess and obsolete inventory and, when
circumstances indicate, we incur charges to write down inventories to their net realizable value. Our review of inventory for excess
and obsolete quantities is based primarily on our estimated forecast of product demand and production requirements for the next
twenty-four months. A significant decrease in demand could result in an increase in the amount of excess inventory quantities on
hand. Additionally, our industry is characterized by regular new product development that could result in an increase in the amount of
obsolete inventory quantities on hand due to cannibalization of existing products. Also, our estimates of future product demand may
prove to be inaccurate, in which case we may be required to incur charges for excess and obsolete inventory. In the future, if
additional inventory write-downs are required, we would recognize additional cost of goods sold at the time of such determination.
Regardless of changes in our estimates of future product demand, we do not increase the value of our inventory above its adjusted cost
basis. Therefore, although we make every effort to ensure the accuracy of our forecasts of future product demand, significant
unanticipated decreases in demand or technological developments could have a significant impact on the value of our inventory and
our reported operating results.
Charges incurred for excess and obsolete inventory were $6.9 million, $5.8 million and $2.6 million for the years ended December 31,
2005, 2004 and 2003, respectively. In 2004, charges incurred for excess and obsolete inventory included $2.4 million recorded to
write down certain foot and ankle implant inventory to its net realizable value as a result of our transition to our CHARLOTTE™ Foot
and Ankle System. In 2005, we incurred approximately $1.5 million in charges within cost of sales to write down inventory to its net
realizable value due to the termination of an agreement to distribute certain third party spinal products in Europe.
Goodwill and long-lived assets. We have approximately $7.8 million of goodwill recorded as a result of acquisition of businesses.
Goodwill is tested for impairment annually, or more frequently if changes in circumstances or the occurrence of events suggest that
impairment exists. Based on our single business approach to decision-making, planning, and resource allocation, we have determined
that we have only one reporting unit for purposes of
40
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
evaluating goodwill for impairment. The annual evaluation of goodwill impairment requires the use of estimates and assumptions to
determine the fair value of our reporting unit using projections of future cash flows. Our estimates of future sales growth rates and
operating margin can significantly affect the outcome of the impairment test. We performed our annual impairment test during the
fourth quarter of 2005 and determined that the fair value of our reporting unit exceeded its carrying value and, therefore, no
impairment charge was necessary.
Our business is capital intensive, particularly as it relates to surgical instrumentation. We depreciate our property, plant and equipment
and amortize our intangible assets based upon our estimate of the respective asset’s useful life. Our estimate of the useful life of an
asset requires us to make judgments about future events, such as product life cycles, new product development, product
cannibalization and technological obsolescence, as well as other competitive factors beyond our control. We account for the
impairment of long-lived assets in accordance SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets.
Accordingly, we evaluate impairments of our property, plant and equipment based upon an analysis of estimated undiscounted future
cash flows. If we determine that a change is required in the useful life of an asset, future depreciation/amortization is adjusted
accordingly. Alternatively, should we determine that an asset has been impaired, an adjustment would be charged to income based on
its fair market value, or discounted cash flows if the fair market value is not readily determinable, reducing income in that period.
Product liability claims. Periodically, claims arise involving the use of our products. We make provisions for claims specifically
identified for which we believe the likelihood of an unfavorable outcome is probable and an estimate of the amount of loss has been
developed. We have recorded at least the minimum estimated liability related to those claims where a range of loss has been
established. As additional information becomes available, we reassess the estimated liability related to our pending claims and make
revisions as necessary. Future revisions in our estimates of the liability could materially impact our results of operation and financial
position. We maintain insurance coverage that limits the severity of any single claim as well as total amounts incurred per policy year,
and we believe our insurance coverage is adequate. We use the best information available to us in determining the level of accrued
product liabilities and we believe our accruals are adequate. During 2004, we recorded $500,000 in product liability reserves for
probable losses following our announcement of a voluntary market withdrawal of a limited number of metal acetabular hip cups
intended for use in our CONSERVE® hip systems. Management developed this estimate and believes that the amount recorded is
appropriate based on assumptions with respect to estimated patient claims related to the market withdrawal and the acceptance of such
claims by our insurer. The nature of a market withdrawal and the associated claims are such that the claims will occur over an
extended period of time. Our estimate includes an assumption for unasserted claims based on management’s industry experience with
similar circumstances. While we believe that the amount recorded related to the market withdrawal is appropriate, it is possible that
changes in assumptions related to potential claims or insurance coverage could have an adverse effect on our estimate. Our accrual for
product liability claims was approximately $850,000 and $1.0 million at December 31, 2005 and 2004, respectively.
Accounting for income taxes. Our effective tax rate is based on income by tax jurisdiction, statutory rates and tax saving initiatives
available to us in the various jurisdictions in which we operate. Significant judgment is required in determining our effective tax rate
and evaluating our tax positions. This process includes assessing temporary differences resulting from differing recognition of items
for income tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included within our
consolidated balance sheet. Realization of deferred tax assets in each taxable jurisdiction is dependent on our ability to generate future
taxable income sufficient to realize the benefits. Management evaluates deferred tax assets on an ongoing basis and provides valuation
allowances to reduce net deferred tax assets to the amount that is more likely than not to be realized.
We have recorded valuation allowances of $6.0 million and $6.8 million as of December 31, 2005 and 2004, respectively, due to
uncertainties related to our ability to realize, before expiration, some of our deferred tax assets for both U.S. and foreign income tax
purposes. These deferred tax assets primarily consist of the carry forward of certain net operating losses and general business tax
credits.
We operate within numerous taxing jurisdictions. We are subject to regulatory review or audit in virtually all of those jurisdictions and
those reviews and audits may require extended periods of time to resolve. Management makes use of all available information and
makes reasoned judgments regarding matters requiring interpretation in
41
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
establishing tax expense, liabilities and reserves. We believe adequate provisions exist for income taxes for all periods and
jurisdictions subject to review or audit.
Impact of Recently Issued Accounting Pronouncements
In November 2004, the FASB issued SFAS No. 151, Inventory Costs — An Amendment of ARB No. 43, Chapter 4 (SFAS No. 151).
SFAS No. 151 will no longer allow companies to capitalize inventory costs on their balance sheet when the production defect rate
varies significantly from the expected rate. All abnormal freight, handling and material waste will be treated as period expenses.
Additionally, SFAS No. 151 requires that a facility’s fixed production overhead be charged to inventory based on a range of “normal”
capacity. If the production level is abnormally low, unallocated overhead should be charged to current period expense. SFAS No. 151
is required to be adopted for annual periods beginning after June 15, 2005; accordingly, we will adopt SFAS No. 151 effective
January 1, 2006. We do not believe that the impact of this standard will have a material impact on our results of operations or financial
statements.
In December 2004, the FASB issued SFAS No. 123R, which requires the recognition of compensation expense for the fair value of
share-based transactions. In April 2005, the SEC amended Rule 4-01(a) of Regulation S-X regarding the compliance date for SFAS
No. 123R. This amendment modified the effective dates of SFAS No. 123R, requiring adoption of this standard on the first interim or
annual reporting period of the first fiscal year beginning on or after June 15, 2005. Accordingly, the Company will adopt SFAS
No. 123R effective January 1, 2006. We further describe this pronouncement and its anticipated impact on our results of operations in
“Net Sales and Expense Components – Stock-based expense.” The effect of expensing the fair value of stock options using the
Black-Scholes model and the provisions of SFAS No. 123 on our historical results of operations is presented in Note 2 to our
consolidated financial statements in Item 8 of this report.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections, which replaced APB Opinion No. 20,
Accounting Changes, and SFAS No. 3, Reporting Accounting Changes in Interim Financial Statements. SFAS No. 154 changes the
requirements for the accounting and reporting of a change in accounting principle and requires retrospective application to prior
periods’ financial statements of changes in accounting principle, unless it is impracticable to determine either the period-specific
effects or the cumulative effect of the change. The Company will adopt the provisions of SFAS No. 154 effective January 1, 2006.
42
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
Our exposure to interest rate risk arises principally from the variable rates associated with our credit facility. On December 31, 2005,
we had borrowings of $3.8 million under our credit facility which are subject to a variable annual interest rate, which is currently 5.7%
per year. The carrying value of these borrowings approximates fair value due to the variable rate. Based on this debt level, a 10%
increase in the interest rate of all such borrowings would cause us to incur an increase in interest expense of approximately $21,000 on
an annual basis. We currently do not hedge our exposure to interest rate fluctuations, but may do so in the future.
Foreign Currency Exchange Rate Fluctuations
Fluctuations in the rate of exchange between the U.S. dollar and foreign currencies could adversely affect our financial results.
Approximately 30% and 33% of our total net sales were denominated in foreign currencies during the years ended December 31, 2005
and 2004, respectively, and we expect that foreign currencies will continue to represent a similarly significant percentage of our net
sales in the future. Costs related to these sales are largely denominated in the same respective currencies, thereby limiting our
transaction risk exposure. However, for sales not denominated in U.S. dollars, if there is an increase in the rate at which a foreign
currency is exchanged for U.S. dollars, it will require more of the foreign currency to equal a specified amount of U.S. dollars than
before the rate increase. In such cases, if we price our products in the foreign currency, we will receive less in U.S. dollars than we did
before the rate increase went into effect. If we price our products in U.S. dollars and competitors price their products in local currency,
an increase in the relative strength of the U.S. dollar could result in our prices not being competitive in a market where business is
transacted in the local currency.
A substantial majority of our sales denominated in foreign currencies are derived from European Union countries and are denominated
in the euro. Additionally, we have significant intercompany receivables from our foreign subsidiaries which are denominated in
foreign currencies, principally the euro and the Japanese yen. Our principal exchange rate risk, therefore, exists between the U.S.
dollar and the euro and the U.S. dollar and the yen. Fluctuations from the beginning to the end of any given reporting period result in
the revaluation of our foreign currency-denominated intercompany receivables and payables, generating currency translation gains or
losses that impact our non-operating income and expense levels in the respective period.
As discussed in Note 2 to our consolidated financial statements in Item 8 of this report, we enter into certain short-term derivative
financial instruments in the form of foreign currency forward contracts. These forward contracts are designed to mitigate our exposure
to currency fluctuations in our intercompany balances denominated in euros, Japanese yen, British pounds, and Canadian dollars. Any
change in the fair value of these forward contracts as a result of a fluctuation in a currency exchange rate is expected to be offset by a
change in the value of the intercompany balance. These contracts are effectively closed at the end of each reporting period.
43
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Item 8. Financial Statements and Supplementary Data.
Wright Medical Group, Inc.
Consolidated Financial Statements
for the Years Ended December 31, 2005, 2004, and 2003
Index to Financial Statements
REPORTS OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
CONSOLIDATED FINANCIAL STATEMENTS
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Cash Flows
Consolidated Statements of Changes in Stockholders’ Equity and Comprehensive Income
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
44
Page
45
47
48
49
50
51
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
The Board of Directors and Stockholders
Wright Medical Group, Inc.:
Report of Independent Registered Public Accounting Firm
We have audited the accompanying consolidated balance sheets of Wright Medical Group, Inc. and subsidiaries as of December 31,
2005 and 2004, and the related consolidated statements of operations, changes in stockholders’ equity and comprehensive income, and
cash flows for each of the years in the three-year period ended December 31, 2005. These consolidated financial statements are the
responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements
based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of
Wright Medical Group, Inc. and subsidiaries as of December 31, 2005 and 2004, and the results of their operations and their cash
flows for each of the years in the three-year period ended December 31, 2005, in conformity with U.S. generally accepted accounting
principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the
effectiveness of the internal control over financial reporting of Wright Medical Group, Inc. and subsidiaries as of December 31, 2005,
based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission (COSO), and our report dated February 27, 2006 expressed an unqualified opinion on management’s
assessment of, and the effective operation of, internal control over financial reporting.
(signed) KPMG LLP
Memphis, Tennessee
February 27, 2006
45
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
The Board of Directors and Stockholders
Wright Medical Group, Inc.:
Report of Independent Registered Public Accounting Firm
We have audited management’s assessment, included in the accompanying Management’s Annual Report on Internal Control Over
Financial Reporting, that Wright Medical Group, Inc. and subsidiaries maintained effective internal control over financial reporting as
of December 31, 2005, based on criteria established in Internal Control—Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission (COSO). The Company’s management is responsible for maintaining
effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial
reporting. Our responsibility is to express an opinion on management’s assessment and an opinion on the effectiveness of the
Company’s internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over
financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over
financial reporting, evaluating management’s assessment, testing and evaluating the design and operating effectiveness of internal
control, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a
reasonable basis for our opinion.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the
maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect
on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections
of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, management’s assessment that Wright Medical Group, Inc. and subsidiaries maintained effective internal control over
financial reporting as of December 31, 2005, is fairly stated, in all material respects, based on criteria established in Internal
Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Also,
in our opinion, Wright Medical Group, Inc. and subsidiaries maintained, in all material respects, effective internal control over
financial reporting as of December 31, 2005, based on criteria established in Internal Control—Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO).
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the
consolidated balance sheets of Wright Medical Group, Inc. and subsidiaries as of December 31, 2005 and 2004, and the related
consolidated statements of operations, changes in stockholders’ equity and comprehensive income, and cash flows for each of the
years in the three-year period ended December 31, 2005, and our report dated February 27, 2006 expressed an unqualified opinion on
those consolidated financial statements.
(signed) KPMG LLP
Memphis, Tennessee
February 27, 2006
46
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Wright Medical Group, Inc.
Consolidated Balance Sheets
(In thousands, except share data)
Assets:
Current assets:
Cash and cash equivalents
Marketable securities
Accounts receivable, net
Inventories
Prepaid expenses
Deferred income taxes
Other current assets
Total current assets
Property, plant and equipment, net
Goodwill
Intangible assets, net
Deferred income taxes
Other assets
Total assets
Liabilities and Stockholders’ Equity:
Current liabilities:
Accounts payable
Accrued expenses and other current liabilities
Current portion of long-term obligations
Total current liabilities
Long-term obligations
Deferred income taxes
Other liabilities
Total liabilities
Commitments and contingencies (Note 15)
Stockholders’ equity:
Common stock, voting, $.01 par value, shares authorized - 100,000,000; shares issued and
outstanding – 34,175,696 in 2005, 33,850,202 in 2004
Additional paid-in capital
Deferred compensation
Accumulated other comprehensive income
Accumulated income (deficit)
Total stockholders’ equity
December 31,
2005
2004
$ 51,277
25,000
61,729
82,381
11,025
24,218
4,751
260,381
81,206
7,829
12,724
8,217
1,453
$371,810
$ 13,572
45,055
5,628
64,255
1,728
151
13,668
79,802
$ 83,470
—
61,662
76,269
4,822
24,082
4,717
255,022
70,207
8,845
17,140
8,873
1,071
$361,158
$ 13,969
44,919
6,331
65,219
5,952
26
13,892
85,089
342
274,312
—
11,957
5,397
292,008
$371,810
339
269,944
(188)
21,642
(15,668)
276,069
$361,158
The accompanying notes are an integral part of these consolidated financial statements.
47
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Wright Medical Group, Inc.
Consolidated Statements of Operations
(In thousands, except per share data)
Net sales
Cost of sales
Gross profit
Operating expenses:
Selling, general and administrative
Research and development
Amortization of intangible assets
Stock-based expense1
Acquired in-process research and development costs
Total operating expenses
Operating income
Interest (income) expense, net
Other expense (income), net
Income before income taxes
Provision for income taxes
Net income
Net income per share (Note 12):
Basic
Diluted
Weighted-average number of shares outstanding – basic
Weighted-average number of shares outstanding – diluted
2005
$319,137
91,740
227,397
Year Ended December 31,
2004
$297,539
84,183
213,356
166,916
22,283
4,250
467
—
193,916
33,481
(176)
237
33,420
12,355
$ 21,065
0.62
$
0.60
$
33,959
35,199
151,144
18,421
3,889
1,489
—
174,943
38,413
1,064
(74)
37,423
13,401
$ 24,022
0.72
$
0.68
$
33,391
35,317
2003
$248,932
67,815
181,117
127,612
16,151
3,562
2,068
4,558
153,951
27,166
1,107
(1,060)
27,119
9,722
$ 17,397
0.53
$
0.50
$
32,857
34,561
1
Amounts presented as non-cash stock-based expense consist of the following for the periods indicated:
Cost of sales
Selling, general and administrative
Research and development
Year Ended December 31,
2004
2005
$
$
12
449
6
467
68
$
1,364
57
$ 1,489
2003
107
$
1,875
86
$ 2,068
The accompanying notes are an integral part of these consolidated financial statements.
48
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Wright Medical Group, Inc.
Consolidated Statements of Cash Flows
(In thousands)
Operating activities:
Net income
Adjustments to reconcile net income to net cash provided by operating
activities:
Depreciation
Amortization of deferred financing costs
Amortization of intangible assets
Deferred income taxes
Stock-based expenses
In-process research and development costs
Other
Changes in assets and liabilities, net of acquisitions:
Accounts receivable
Inventories
Marketable securities
Other current assets
Accounts payable
Accrued expenses and other liabilities
Net cash provided by operating activities
Investing activities:
Capital expenditures
Purchase of tangible and intangible assets (Note 3)
Other
Net cash used in investing activities
Financing activities:
Issuance of common stock
Financing under factoring agreements, net
Payments of bank and other financing
Net cash (used in) provided by financing activities
Effect of exchange rates on cash and cash equivalents
Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents, beginning of period
Cash and cash equivalents, end of period
2005
Year Ended December 31,
2004
2003
$ 21,065
$ 24,022
$ 17,397
17,895
262
4,250
(329)
467
—
1,386
(5,177)
(9,364)
(25,000)
(6,062)
647
5,251
5,291
(30,356)
(1,227)
—
(31,583)
2,930
(1,208)
(7,101)
(5,379)
(522)
(32,193)
83,470
$ 51,277
17,278
261
3,889
5,068
1,489
—
623
(3,811)
(7,861)
—
(3,223)
(849)
479
37,365
(18,316)
(161)
49
(18,428)
4,056
(29)
(6,332)
(2,305)
267
16,899
66,571
$ 83,470
13,948
261
3,562
4,565
2,068
4,558
275
(11,359)
(3,466)
—
(676)
3,153
5,779
40,065
(18,116)
(7,799)
71
(25,844)
1,678
4,680
(5,844)
514
463
15,198
51,373
$ 66,571
The accompanying notes are an integral part of these consolidated financial statements.
49
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Wright Medical Group, Inc.
Consolidated Statements of Changes in Stockholders’ Equity and Comprehensive Income
For the Years Ended December 31, 2003, 2004 and 2005
(In thousands, except share data)
Common Stock, Voting
Number of
Shares
Amount
Additional
Paid-in
Capital
Accumulated
(Deficit)
Income Compensation
Accumulated
Other
Deferred Comprehensive
Income
Total
Stockholders’
Equity
32,712,374
$
327
$260,640
$(57,087)
$ (3,164)
$ 4,283
$204,999
—
—
—
—
—
—
17,397
—
—
—
—
11,392
17,397
11,392
328,373
3
1,675
—
—
—
—
—
—
784
593
(237)
—
—
—
—
—
—
1,475
237
28,789
1,678
784
2,068
—
—
—
—
—
Balance at December 31,
2002
2003 Activity:
Net income
Foreign currency translation
Total comprehensive
income
Issuance of common stock,
net of costs
Tax benefit of employee
stock option exercises
Stock-based compensation
Forfeiture of stock options
Balance at December 31,
2003
33,040,747
$
330
$263,455
$(39,690)
$ (1,452)
$15,675
$238,318
2004 Activity:
Net income
Foreign currency translation
Total comprehensive
income
Issuance of common stock,
net of costs
Tax benefit of employee
stock option exercises
Stock-based compensation
Forfeiture of stock options
Balance at December 31,
—
—
—
—
—
—
24,022
—
—
—
—
5,967
24,022
5,967
809,455
9
4,047
—
—
—
—
—
—
2,217
331
(106)
—
—
—
—
—
—
1,158
106
29,989
4,056
2,217
1,489
—
—
—
—
—
2004
33,850,202
$
339
$269,944
$(15,668)
$ (188)
$21,642
$276,069
2005 Activity:
Net income
Foreign currency translation
Total comprehensive
income
Issuance of common stock,
net of costs
Tax benefit of employee
stock option exercises
Stock-based compensation
Forfeiture of stock options
Balance at December 31,
—
—
—
—
—
—
—
325,494
3
2,927
—
—
—
—
—
—
1,162
288
(9)
21,065
—
—
—
—
—
—
—
—
—
—
—
179
9
—
(9,685)
21,065
(9,685)
—
11,380
—
—
—
—
2,930
1,162
467
—
2005
34,175,696
$
342
$274,312
$ 5,397
$ —
$11,957
$292,008
The accompanying notes are an integral part of these consolidated financial statements.
50
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Organization and Description of Business:
Wright Medical Group, Inc. (the “Company”), through Wright Medical Technology, Inc. and other operating subsidiaries, is a global
medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologics products.
The Company’s products are sold through a network of independent sales representatives in the United States (“U.S.”) and by a
combination of employee sales representatives, independent sales representatives, and stocking distributors outside the U.S. The
Company promotes its products in over 60 countries with principal markets in the U.S., Europe, and Japan. The Company is
headquartered in suburban Memphis, Tennessee.
The Company was incorporated on November 23, 1999 as a Delaware corporation (previously named Wright Acquisition Holdings,
Inc.) and had no operations until an investment group led by Warburg, Pincus Equity Partners, L.P. (“Warburg”) acquired majority
ownership of Wright Medical Technology, Inc. (the “Predecessor Company”) on December 7, 1999. This transaction, which
represents a recapitalization of the Predecessor Company and the inception of the Company in its present form, was accounted for
using the purchase method of accounting.
On December 22, 1999 the Company acquired all of the outstanding common stock of Cremascoli Ortho Holding, S.A.
(“Cremascoli”), an orthopaedic medical device company headquartered in Toulon, France. The acquisition was accounted for using
the purchase method of accounting and, accordingly, the results of operations of Cremascoli have been included in the Company’s
consolidated financial statements from the date of acquisition.
On July 18, 2001, the Company completed its initial public offering (the “IPO”), issuing 7,500,000 shares of common stock which
generated net proceeds of $84.8 million. On March 6, 2002, the Company and certain selling stockholders completed a secondary
offering which generated net proceeds of $49.5 million.
2. Summary of Significant Accounting Policies:
Principles of Consolidation. The accompanying consolidated financial statements include the accounts of the Company and its wholly
owned domestic and international subsidiaries. All significant intercompany accounts and transactions have been eliminated in
consolidation.
Use of Estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the U.S.
requires management to make estimates and assumptions that affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those estimates. The most significant areas requiring the use of management
estimates relate to revenue recognition, the determination of allowances for doubtful accounts and excess and obsolete inventories, the
evaluation of goodwill and long-lived assets, product liability claims and accounting for income taxes.
Cash and Cash Equivalents. Cash and cash equivalents include all cash balances and short-term investments with original maturities
of three months or less.
Marketable Securities. During 2005, the Company invested $25 million of its excess cash balance in marketable debt securities that
are not considered cash equivalents. The Company classifies these debt securities as trading securities and includes these amounts as
“Marketable Securities” in its consolidated balance sheet. The Company recognizes realized and unrealized gains or losses on the
purchase or sale of these securities in the period incurred in the accompanying consolidated statement of operations. For the year
ended December 31, 2005, the Company did not incur any realized or unrealized gains or losses related to these securities.
Inventories. The Company’s inventories are valued at the lower of cost or market on a first-in, first-out (“FIFO”) basis. Inventory
costs include material, labor costs and manufacturing overhead. The Company regularly reviews inventory quantities on hand for
excess and obsolete inventory and, when circumstances indicate, the Company incurs charges to write down inventories to their net
realizable value. The Company’s review of inventory for excess
51
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
and obsolete quantities is based primarily on its estimated forecast of product demand and production requirements for the next
twenty-four months. Charges incurred for excess and obsolete inventory were $6.9 million, $5.8 million and $2.6 million for the years
ended December 31, 2005, 2004 and 2003, respectively. In 2005, charges incurred for excess and obsolete inventory included
$1.5 million recorded to write down certain inventory to its net realizable value due to the termination of an agreement to distribute
certain third party spinal products in Europe. In 2004, charges incurred for excess and obsolete inventory included $2.4 million
recorded to write down certain foot and ankle implant inventory to its net realizable value as a result of the Company’s transition to
the CHARLOTTE™ Foot and Ankle System from a line of products supplied by a third party vendor pursuant to a distribution
agreement that expired in the first quarter of 2005.
Product Liability Claims. The Company makes provisions for claims specifically identified for which it believes the likelihood of an
unfavorable outcome is probable and an estimate of the amount of loss has been developed. The Company has recorded at least the
minimum estimated liability related to those claims where a range of loss has been established. The Company’s accrual for product
liability claims was approximately $850,000 and $1.0 million at December 31, 2005 and 2004, respectively.
Property, Plant and Equipment. The Company’s property, plant and equipment is stated at cost. Depreciation, which includes
amortization of assets under capital lease, is provided on a straight-line basis over the estimated useful lives based on the following
categories:
Land improvements
Buildings
Machinery and equipment
Furniture, fixtures and office equipment
Surgical instruments
15 to 25 years
10 to 45 years
3 to 20 years
1 to 14 years
5 to 6 years
Expenditures for major renewals and betterments that extend the useful life of the assets are capitalized. Maintenance and repair costs
are charged to expense as incurred. Upon sale or retirement, the asset cost and related accumulated depreciation are eliminated from
the respective accounts and any resulting gain or loss is included in income.
Intangible Assets and Goodwill. Goodwill is recognized for the excess of the purchase price over the fair value of assets of businesses
acquired. Goodwill is required to be tested for impairment at least annually. Unless circumstances otherwise dictate, we perform our
annual impairment test in the fourth quarter. Accordingly, during the fourth quarter of 2005, the Company evaluated goodwill for
impairment and determined that the fair values of its reporting unit exceeded its carrying value, indicating that goodwill was not
impaired. Based on the Company’s single business approach to decision-making, planning, and resource allocation, management has
determined that the Company has only one reporting unit for purposes of evaluating goodwill for impairment.
The Company’s intangible assets with estimable useful lives are amortized on a straight line basis over their respective estimated
useful lives to their estimated residual values, and are reviewed for impairment in accordance with Statement of Financial Accounting
Standards (“SFAS”) No. 144, Accounting for Impairment or Disposal of Long-Lived Assets. The weighted average amortization
periods for completed technology, distribution channels, trademarks and licenses are 8 years, 10 years, 9 years, and 6 years,
respectively. The weighted average amortization period of the Company’s intangible assets on a combined basis is 8 years.
Valuation of Long-Lived Assets. Management periodically evaluates carrying values of long-lived assets, including property, plant and
equipment and intangible assets, when events and circumstances indicate that these assets may have been impaired. The Company
accounts for the impairment of long-lived assets in accordance SFAS No. 144, Accounting for the Impairment or Disposal of
Long-Lived Assets. Accordingly, the Company evaluates impairment of its property, plant and equipment based upon an analysis of
estimated undiscounted future cash flows. If it is determined that a change is required in the useful life of an asset, future
depreciation/amortization is adjusted
52
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
accordingly. Alternatively, should the Company determine that an asset is impaired, an adjustment would be charged to income based
on its fair market value, or discounted cash flows if the fair market value is not readily determinable, reducing income in that period.
Allowances for Doubtful Accounts. The Company experiences some credit loss on its accounts receivable and accordingly it must
make estimates related to the ultimate collection of its accounts receivable. Specifically, management analyzes the Company’s
accounts receivable, historical bad debt experience, customer concentrations, customer credit-worthiness, and current economic
trends, when evaluating the adequacy of its allowance for doubtful accounts.
The majority of the Company’s receivables are from hospitals, many of which are government funded. Accordingly, the Company’s
collection history with this class of customer has been favorable. Historically, the Company has experienced minimal bad debts from
its hospital customers and more significant bad debts from certain international distributors, typically as a result of specific financial
difficulty or geo-political factors. The Company writes off receivables when it determines that the receivables are uncollectible,
typically upon customer bankruptcy or the customer’s non-response to collection efforts. The Company’s allowance for doubtful
accounts totaled $2.0 million and $1.8 million at December 31, 2005 and 2004, respectively.
Concentrations of Supply of Raw Material. The Company relies on a limited number of suppliers for the components used in the
Company’s products. The Company’s reconstructive joint devices are produced from various surgical grades of titanium, cobalt
chrome and stainless steel, various grades of high-density polyethylenes, silicone elastomer and ceramics. The Company relies on one
supplier for the silicone elastomer used in the Company’s extremity products. The Company is aware of only two suppliers of silicone
elastomer to the medical device industry for permanent implant usage. Further, the Company relies on one supplier of ceramics for use
in the Company’s hip products. In addition, for the Company’s biologics products, it presently depends on a single source for
demineralized bone matrix (“DBM”) and cancellous bone matrix (“CBM”) materials. Two not-for-profit tissue banks supplied the
Company with all of the DBM and CBM that it used in 2005 in its allograft products. Further, the Company relies on one supplier for
its GRAFTJACKET® family of soft tissue repair and graft containment products, as well as one supplier for its ADCON® Gel
products.
Income Taxes. Income taxes are accounted for pursuant to the provisions of SFAS No. 109, Accounting for Income Taxes (“SFAS
No. 109”). The Company’s effective tax rate is based on income by tax jurisdiction, statutory rates and tax saving initiatives available
to it in the various jurisdictions in which it operates. Significant judgment is required in determining the Company’s effective tax rate
and evaluating its tax positions. This process includes assessing temporary differences resulting from differing recognition of items for
income tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included within the
Company’s consolidated balance sheet.
Revenue Recognition. The Company’s revenues are generated through two types of customers, hospitals and stocking distributors,
with the majority of the Company’s revenue derived from sales to hospitals. The Company’s products are sold through a network of
independent sales representatives in the U.S. and by a combination of employee sales representatives, independent sales
representatives, and stocking distributors outside the U.S. Revenues from sales to hospitals are recorded when the hospital takes title
to the product, which is when the product is surgically implanted in a patient and a purchase order is received from the hospital. The
Company views the receipt of a purchase order as the evidence of customer acceptance of the product.
The Company records revenues from sales to its stocking distributors outside the U.S. at the time the product is shipped to the
distributor. Stocking distributors, who sell the products to their customers, take title to the products and assume all risks of ownership.
The Company’s distributors are obligated to pay within specified terms regardless of when, if ever, they sell the products. In general,
the distributors do not have any rights of return or exchange; however, in limited situations the Company has repurchase agreements
with certain stocking distributors. Those certain agreements require the Company to repurchase a specified percentage of the inventory
purchased by
53
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
the distributor within a specified period of time prior to the expiration of the contract. During those specified periods, the Company
defers the applicable percentage of the sales. Approximately $170,000 and $90,000 of deferred revenue related to these types of
agreements was recorded at December 31, 2005 and 2004, respectively.
The Company must make estimates of potential future product returns related to current period product revenue. The Company
develops these estimates by analyzing historical experience related to product returns. Judgment must be used and estimates made in
connection with establishing the allowance for sales returns in any accounting period. An allowance for sales returns of approximately
$430,000 and $400,000 is included as a reduction of accounts receivable at December 31, 2005 and 2004, respectively.
Shipping and Handling Costs. The Company incurs shipping and handling costs associated with the shipment of goods to customers,
independent distributors and its subsidiaries. All shipping and handling amounts billed to customers are included in net sales. All
shipping and handling costs associated with the shipment of goods to customers are included in cost of sales. All other shipping and
handling costs are included in selling, general and administrative expenses.
Research and Development Costs. Research and development costs are charged to expense as incurred.
Foreign Currency Translation. The financial statements of the Company’s international subsidiaries are translated into U.S. dollars
using the exchange rate at the balance sheet date for assets and liabilities and the weighted average exchange rate for the applicable
period for revenues, expenses, gains and losses. Translation adjustments are recorded as a separate component of comprehensive
income. Gains and losses resulting from transactions denominated in a currency other than the local functional currency are included
in “Other expense (income), net.”
Comprehensive Income. Comprehensive income is defined as the change in equity during a period related to transactions and other
events and circumstances from non-owner sources. It includes all changes in equity during a period except those resulting from
investments by owners and distributions to owners. The difference between the Company’s net income and its comprehensive income
is wholly attributable to foreign currency translation.
Stock-Based Compensation. At December 31, 2005, the Company has two stock-based employee compensation plans, which are
described in Note 13. The Company accounts for those plans under the intrinsic value method in accordance with the provisions of
Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees. Accordingly, compensation cost
related to stock option grants to employees has been recognized only to the extent that the fair market value of the stock exceeds the
exercise price of the stock option at the date of the grant. Non-employee stock-based compensation is accounted for in accordance
with SFAS No. 123, Accounting for Stock-Based Compensation.
The following table illustrates the effect on net income and earnings per share if the Company had applied the fair value recognition
provisions of SFAS No. 123 to non-cash stock-based employee compensation (in thousands, except per share amounts):
54
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Net income, as reported
Add: Stock-based employee compensation cost recognized under intrinsic value
method, net of tax effects
Less: Stock-based employee compensation expense determined under fair value
based method, net of tax effects
Pro forma net income
Net income per share:
Basic, as reported
Basic, pro forma
Diluted, as reported
Diluted, pro forma
2005
$ 21,065
Year Ended December 31,
2004
$24,022
2003
$17,397
151
681
920
(12,972)
$ 8,244
(8,626)
$16,077
$
$
$
$
0.62
0.24
0.60
0.24
$
$
$
$
0.72
0.48
0.68
0.47
(4,334)
$13,983
$
$
$
$
0.53
0.43
0.50
0.41
In December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 123 (Revised 2004), Share Based Payment
(“SFAS No. 123R”), effective for interim or annual reporting periods beginning after June 15, 2005. SFAS No. 123R requires the
recognition of compensation expense for the fair value of share-based transactions. The fair value must be determined as of the date of
grant using a valuation model such as Black-Scholes or a binomial lattice model. In April 2005, the SEC amended Rule 4-01(a) of
Regulation S-X regarding the compliance date for SFAS No. 123R. This amendment modified the effective dates of SFAS No. 123R,
requiring adoption of this standard on the first interim or annual reporting period of the first fiscal year beginning on or after June 15,
2005. Accordingly, the Company adopted SFAS No. 123R effective January 1, 2006. Although management’s evaluation of SFAS
No. 123R is not complete, the Company estimates that the amount of non-cash stock-based compensation that it will record in 2006
pursuant to the adoption of SFAS No. 123R will be significant. The effect on the Company’s historical results of operations of
expensing the fair value of stock options using the Black-Scholes model and the provisions of SFAS No. 123 is presented in the table
above. Note 13 provides information related to the Company’s assumptions in applying the Black-Scholes methodology to its option
grants.
Fair Value of Financial Instruments. The carrying value of cash and cash equivalents, accounts receivable, accounts payable and notes
payable approximates the fair value of these financial instruments at December 31, 2005 and 2004 due to their short maturities or
variable rates.
Derivative Instruments and Hedging Activities . The Company accounts for derivative instruments and hedging activities under SFAS
No. 133, Accounting for Derivative Instruments and Hedging Activities, as amended by SFAS No. 138. Accordingly, all of the
Company’s derivative instruments are recorded on the balance sheet as either an asset or liability and measured at fair value. The
changes in the derivative’s fair value are recognized currently in earnings unless specific hedge accounting criteria are met.
The Company employs a derivative program, which began in 2004, using 30-day foreign currency forward contracts to mitigate the
risk of currency fluctuations on its intercompany receivable and payable balances that are denominated in foreign currencies. These
forward contracts are expected to offset the transactional gains and losses on the related intercompany balances. These forward
contracts are not designated as hedging instruments under SFAS No. 133. Accordingly, the changes in the fair value and the
settlement of the contracts are recognized in the period incurred in the accompanying consolidated statement of operations.
The Company recorded net gains of approximately $1.5 million for the year ended December 31, 2005, and net losses of
approximately $790,000 during the year ended December 31, 2004, on foreign currency contracts, which
55
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
are included in “Other (income) expense, net” in the Company’s consolidated statements of operations. These gains and losses
substantially offset translation losses and gains recorded on the Company’s intercompany receivable and payable balances, also
included in “Other (income) expense, net.” At December 31, 2005 and 2004, the Company had no foreign currency contracts
outstanding.
Supplemental Cash Flow Information. Cash paid for interest expense and income taxes was as follows (in thousands):
Interest
Income taxes
Year Ended December 31,
2004
2005
657
$
$17,057
717
$
$ 8,289
2003
994
$
$ 4,411
During 2004, the Company favorably resolved certain income tax contingencies associated with the Company’s acquisition of
Cremascoli, resulting in a decrease in goodwill of approximately $3.0 million. Additionally, the Company entered into capital leases
of approximately $1.6 million, $1.1 million, and $630,000 during 2005, 2004, and 2003, respectively.
Reclassifications. Certain prior year amounts have been reclassified to conform to the 2005 presentation.
Recent Pronouncements. In November 2004, the FASB issued SFAS No. 151, Inventory Costs — An Amendment of ARB No. 43,
Chapter 4 (“SFAS No. 151”). SFAS No. 151 will no longer allow companies to capitalize inventory costs on their balance sheet when
the production defect rate varies significantly from the expected rate. All abnormal freight, handling and material waste will be treated
as period expenses. Additionally, SFAS No. 151 requires that a facility’s fixed production overhead be charged to inventory based on
a range of “normal” capacity. If the production level is abnormally low, unallocated overhead should be charged to current period
expense. SFAS No. 151 is required to be adopted for annual periods beginning after June 15, 2005. Accordingly, the Company will
adopt the provisions of SFAS No. 151 effective January 1, 2006. Management does not believe that the impact of this statement will
have a material impact on the Company’s results of operations or financial statements.
In April 2005, the SEC amended Rule 4-01(a) of Regulation S-X regarding the compliance date for SFAS No. 123 (Revised 2004),
Share Based Payment (“SFAS No. 123R”). This amendment modified the effective dates of SFAS No. 123R, requiring adoption of
this standard on the first interim or annual reporting period of the first fiscal year beginning on or after June 15, 2005. Accordingly,
the Company will adopt SFAS No. 123R effective January 1, 2006. The Company anticipates that it will record material amounts of
incremental non-cash stock-based expense in future periods following the adoption of SFAS No. 123R.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections, which replaced APB Opinion No. 20,
Accounting Changes, and SFAS No. 3, Reporting Accounting Changes in Interim Financial Statements. SFAS No. 154 changes the
requirements for the accounting and reporting of a change in accounting principle and requires retrospective application to prior
periods’ financial statements of changes in accounting principle, unless it is impracticable to determine either the period-specific
effects or the cumulative effect of the change. The Company will adopt the provisions of SFAS No. 154 effective January 1, 2006.
3. Acquisition of Assets:
On March 5, 2003, the Company completed an acquisition of certain assets from Gliatech Inc. related to its ADCON® Gel technology
for $8.4 million in cash. Additionally, the Company entered into a royalty agreement that requires the Company to pay a royalty on
future product sales. The Company paid $840,000 of the purchase price as a deposit in the fourth quarter of 2002, and $3.4 million in
the first quarter of 2003. The remaining $4.2 million was paid in the second quarter of 2003 upon final receipt of all assets. The
following table summarizes the allocation of the purchase price (in thousands):
56
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Inventories
Property, plant and equipment
Acquired in-process research and development
Intangible assets:
Completed Technology
Trademarks
Other
$ 1,312
160
4,558
1,575
554
286
$ 8,445
In connection with the acquisition of these assets, the Company engaged an independent third party to conduct a valuation of the
intangible assets acquired. The value assigned to acquired in-process research and development (“IPRD”) was $4.6 million of the
purchase price. Accordingly, this amount was expensed in the first quarter of 2003. The value assigned to IPRD was determined by
estimating the costs to develop the IPRD into commercially viable products, estimating the resulting cash flows from such projects,
and discounting the net cash flows using a 32% risk adjusted discount rate. This discount rate reflected uncertainties surrounding the
successful development of the IPRD.
In June 2005, the Company’s pre-market approval application (PMA) with the United States Food and Drug Administration (“FDA”)
for the ADCON® Gel product was withdrawn. Based on the progress of the review to date, the Company determined that in order to
adequately address the requests made by the FDA in connection with the review of the application, withdrawal of the filing at this
time is appropriate. The Company is evaluating whether to continue to pursue re-submission. If re-submitted, there can be no
assurance that the FDA will accept another submission in a timely manner or at all.
4. Inventories:
Inventories consist of the following (in thousands):
Raw materials
Work-in-process
Finished goods
5. Property, Plant and Equipment:
Property, plant and equipment consists of the following (in thousands):
Land and land improvements
Buildings
Machinery and equipment
Furniture, fixtures and office equipment
Construction in progress
Surgical instruments
Less: Accumulated depreciation
57
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
December 31,
2005
$ 4,186
14,417
63,778
$82,381
2004
$ 3,373
14,306
58,590
$76,269
December 31,
$
2005
2,329
8,458
33,530
29,193
2,654
72,088
148,252
(67,046)
$ 81,206
$
2004
1,944
8,773
31,849
25,444
2,284
56,963
127,257
(57,050)
$ 70,207
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The components of property, plant and equipment recorded under capital leases consist of the following (in thousands):
Land and land improvements
Buildings
Machinery and equipment
Furniture, fixtures and office equipment
Less: Accumulated depreciation
December 31,
2005
235
$
3,018
6,346
2,309
11,908
(5,663)
$ 6,245
2004
269
$
3,247
8,103
2,135
13,754
(5,940)
$ 7,814
Depreciation expense approximated $17.9 million, $17.3 million, and $13.9 million for the years ended December 31, 2005, 2004, and
2003, respectively, and included amortization of assets under capital leases.
6. Goodwill and Intangible Assets:
Changes in the carrying amount of goodwill occurring during the year ended December 31, 2005 are as follows (in thousands):
Goodwill, at December 31, 2004
Less: Foreign currency translation
Goodwill, at December 31, 2005
The components of the Company’s identifiable intangible assets are as follows (in thousands):
$ 8,845
(1,016)
$ 7,829
Distribution channels
Completed technology
Licenses
Trademarks
Other
Less: Accumulated amortization
Intangible assets, net
December 31, 2005
December 31, 2004
Accumulated
Amortization
$10,908
2,353
1,847
230
2,781
$18,119
Cost
$ 18,173
5,243
2,756
657
4,014
30,843
(18,119)
$ 12,724
Accumulated
Amortization
$10,399
1,733
1,538
152
1,826
$15,648
Cost
$ 20,797
5,348
2,683
657
3,303
32,788
(15,648)
$ 17,140
Based on the intangible assets held at December 31, 2005, we expect to amortize approximately $4.0 million in 2006, $3.0 million in
2007, $2.7 million in 2008, $2.4 million in 2009 and $350,000 in 2010.
58
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
7. Accrued Expenses and Other Current Liabilities:
Accrued expenses and other current liabilities consist of the following (in thousands):
Employee benefits
Advances from factoring arrangement
Royalties
Taxes other than income
Commissions
Professional fees
Purchased technology
Legal
Other
8. Long-Term Obligations:
Long-term obligations consist of the following (in thousands):
Notes payable
Capital lease obligations
Less: current portion
December 31,
2005
$10,873
3,547
4,455
5,604
3,982
3,994
1,500
1,429
9,671
$45,055
2004
$11,476
5,242
4,664
4,120
3,818
3,129
1,500
1,153
9,817
$44,919
December 31,
2005
$ 3,750
3,606
7,356
(5,628)
$ 1,728
2004
$ 8,750
3,533
12,283
(6,331)
$ 5,952
In August 2001, the Company entered into a five-year senior credit facility with a syndicate of commercial banks. This senior credit
facility consists of $20 million in term loans and a revolving loan facility of up to $60 million. The Company had borrowings
outstanding under the term loan of $3.8 million and $8.8 million at December 31, 2005 and 2004, respectively. The remaining balance
under the term loan will be repaid in 2006 in accordance with the company’s credit agreement.
Borrowings under the senior credit facility are guaranteed by all of the Company’s subsidiaries and collateralized by all of the assets
of Wright Medical Technology, Inc., the Company’s wholly-owned subsidiary. The credit facility contains customary covenants
including, among other things, restrictions on the ability to pay cash dividends, prepay debt, incur additional debt and sell assets. The
credit facility also requires the Company to maintain certain financial covenants, including a specified consolidated leverage (or
debt-to-equity) ratio and a specified consolidated fixed charge coverage ratio. In the event that the Company violates any covenants, it
could be required to repay the remaining balance of the debt. Additionally, should the Company be required to repay the loan before
its scheduled maturity, a charge to operating income for unamortized financing costs would be incurred. At the Company’s option,
borrowings under the credit facility bear interest either at a rate equal to a fixed base rate plus a spread of 0.75% to 1.25% or at a rate
equal to an adjusted LIBOR plus a spread of 1.75% to 2.25%, depending on the consolidated leverage ratio, with a current annual rate
of 5.7%.
At December 31, 2005, the Company had availability under committed credit facilities, after considering outstanding letters of credit,
totaling $59.9 million.
As discussed in Note 5, the Company has acquired certain property and equipment pursuant to capital leases. These leases have
various maturity dates ranging from one to seven years with interest rates ranging from 4.0% to 8.9%. At December 31, 2005, future
minimum lease payments under capital lease obligations, together with the present value
59
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
of the net minimum lease payments, are as follows (in thousands):
2006
2007
2008
2009
2010
Thereafter
Total minimum payments
Less amount representing interest
Present value of minimum lease payments
Current portion
Long-term portion
9. Other Long-Term Liabilities:
Other long-term liabilities consist of the following (in thousands):
Accrued income taxes payable
Other
10. Capital Stock:
$ 2,008
1,179
399
172
94
6
3,858
(252)
3,606
(1,878)
$ 1,728
December 31,
2005
$13,045
623
$13,668
2004
$12,951
941
$13,892
Common Stock. The Company is authorized to issue up to 100,000,000 shares of voting common stock. The Company has 65,824,304
shares of voting common stock available for future issuance at December 31, 2005.
Warrants. In connection with the December 1999 recapitalization, the Company issued warrants to stockholders and certain
employees to purchase an aggregate of 727,276 shares of the Company’s common stock at an exercise price of $4.35 per share. The
warrants were exercisable at any time after issuance and, unless exercised, expired five years from the date of issuance. During the
years ended December 31, 2004 and 2003, warrants for 353,209 and 6,691 shares were exercised, respectively. All warrants were
exercised as of December 31, 2004.
11. Income Taxes:
The components of the Company’s income before income taxes are as follows (in thousands):
Domestic
Foreign
Income before income taxes
60
2005
$ 43,588
(10,168)
$ 33,420
Year Ended December 31,
2004
$40,437
(3,014)
$37,423
2003
$25,675
1,444
$27,119
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The components of the Company’s provision for income taxes are as follows (in thousands):
Current provision:
Domestic:
Federal
State
Foreign
Deferred provision (benefit):
Domestic:
Federal
State
Foreign
Total provision for income taxes
Year Ended December 31,
2004
2005
2003
$ 9,777
1,709
1,385
$12,815
811
4,401
$ 3,080
203
1,404
3,013
605
(4,134)
$12,355
(197)
803
(5,232)
$13,401
4,313
1,098
(376)
$ 9,722
A reconciliation of the statutory federal income tax rate to the Company’s effective income tax rate is as follows:
Income tax provision at statutory rate
State tax provision
Change in valuation allowance
Meals and entertainment limitation
Research and development credit
Tax exempt interest
Other, net
Total
2005
35.0%
5.3%
(1.2%)
1.5%
(2.3%)
(1.2%)
(0.1%)
37.0%
Year Ended December 31,
2004
35.0%
4.8%
(3.1%)
1.0%
(2.6%)
—
0.7%
35.8%
2003
35.0%
4.4%
4.5%
1.2%
(9.9%)
—
0.7%
35.9%
The significant components of the Company’s deferred tax assets and liabilities as of December 31, 2005 and 2004 are as follows (in
thousands):
December 31,
2005
2004
$13,924
2,341
—
18,031
5,230
11,856
(5,964)
45,418
6,205
2,661
4,297
13,163
$32,255
$13,755
2,309
621
19,399
5,660
11,718
(6,820)
46,642
4,523
3,767
5,570
13,860
$32,782
Deferred tax assets:
Operating loss carryforwards
General business credit carryforward
Alternative minimum tax credits
Reserves and allowances
Amortization
Other
Valuation allowance
Total deferred tax assets
Deferred tax liabilities:
Depreciation
Acquired intangible assets
Other
Total deferred tax liabilities
Net deferred tax assets
61
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Provisions for federal income taxes are not made on the undistributed earnings of foreign subsidiaries when earnings are considered
permanently invested. Deferred taxes are not provided for temporary differences related to earnings of non-U.S. subsidiaries that are
intended to be permanently reinvested. At December 31, 2005, the Company did not have undistributed earnings of foreign
subsidiaries, as total earnings from these subsidiaries have been offset by losses.
At December 31, 2005, the Company had net operating loss carryforwards for U.S. federal income tax purposes of approximately
$15.2 million, which expire in 2017 and 2018. Additionally, the Company had general business credit carryforwards of approximately
$2.3 million, which expire beginning in 2007 and extending through 2016. At December 31, 2005, the Company had foreign net
operating loss carryforwards of approximately $25.4 million, of which $4.5 million expires beginning in 2009 and extending through
2015.
Certain of the Company’s U.S. and foreign net operating losses and general business credit carryforwards are subject to various
limitations. The Company maintains valuation allowances for these net operating losses and tax credit carryforwards that are expected
to expire unused due to these limitations.
12. Earnings Per Share:
SFAS No. 128, Earnings Per Share, requires the presentation of basic and diluted earnings per share. Basic earnings per share is
calculated based on the weighted-average shares of common stock outstanding during the period. Diluted earnings per share is
calculated to include any dilutive effect of the Company’s common stock equivalents, which consist of stock options and warrants.
The dilutive effect of such instruments is calculated using the treasury-stock method.
The weighted-average number of common shares outstanding for basic and diluted earnings per share purposes is as follows (in
thousands):
Weighted-average number of common shares outstanding — basic
Common stock equivalents
Weighted-average number of common shares outstanding — diluted
2005
33,959
1,240
35,199
Year Ended December 31,
2004
33,391
1,926
35,317
2003
32,857
1,704
34,561
For the years ended December 31, 2005, 2004 and 2003, options to purchase approximately 2.7 million, 1.7 million and 671,000,
respectively, shares of the Company’s common stock were excluded from the calculation of diluted earnings per share because the
effect was antidilutive. These stock options were antidilutive because the exercise price of the options was greater than the average
market price of common stock for the respective period.
13. Stock Option Plans:
At December 31, 2004, the Company has two stock-based incentive plans, which are described below. As permitted by SFAS
No. 123, Accounting for Stock-Based Compensation, the Company applies APB Opinion No. 25 and related interpretations in
accounting for its employee stock option plan. Accordingly, compensation cost related to stock option grants to employees has been
recognized only to the extent that the fair market value of the stock exceeds the exercise price of the stock option at the date of the
grant.
Equity Incentive Plan
On December 7, 1999, the Company adopted the 1999 Equity Incentive Plan (the “Plan”), which was subsequently amended and
restated on July 6, 2001, May 13, 2003, May 13, 2004, and May 12, 2005. The Plan authorizes the
62
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Company to grant options to purchase up to 9,767,051 shares of common stock. Under the Plan, options to purchase common stock
generally are exercisable in increments of 25% annually in each of the first through fourth anniversaries of the date of grant. Options
to purchase Series A Preferred Stock that were outstanding at the time the Company completed its IPO in July 2001 became options to
purchase the Company’s common stock. Those options were immediately exercisable upon their issuance. All the options issued
under the plan expire after ten years.
The weighted-average fair value of the Company’s options granted in 2005, 2004 and 2003 was $11.59 per share, $17.39 per share
and $12.96 per share, respectively. The fair value of these options is estimated on the date of grant using the Black-Scholes
methodology required by SFAS No. 123 for publicly traded companies. In applying the Black-Scholes methodology to the option
grants, the Company used the following assumptions:
Risk-free interest rate
Expected option life
Expected price volatility
2005
4.0% - 4.5%
7 years
39.8%
Year Ended December 31,
2004
4.0% - 4.8%
7 years
50.1%
2003
3.6% - 4.3%
7 years
54.3%
The assumed forfeiture rate was not material to the calculation. The Company does not assume a dividend yield as it has never
declared or paid cash dividends on its common stock.
A summary of the Company’s stock option activity is as follows (shares in thousands):
Outstanding at December 31, 2002
Granted
Exercised
Forfeited or expired
Outstanding at December 31, 2003
Granted
Exercised
Forfeited or expired
Outstanding at December 31, 2004
Granted
Exercised
Forfeited or expired
Outstanding at December 31, 2005
Common Stock
Weighted
Avg.
Exercise
Price
$ 7.58
21.80
4.67
7.25
$ 12.28
30.61
7.53
24.34
$ 19.68
23.82
8.61
30.01
$ 19.55
Shares
3,288
1,333
(309)
(78)
4,234
2,458
(505)
(359)
5,828
1,819
(314)
(1,145)
6,188
As of December 31, 2005, there were 1,840,764 options available for future issuance.
In 2005, 2004, and 2003, the Company granted certain independent distributors common stock options for a total of 42,100, 19,900
and 16,750 shares, respectively, under the Plan. The distributors were given options to purchase common stock, exercisable in 25%
increments on the first through fourth anniversaries of the date of grant, at a weighted-average exercise price of $25.09, $32.56 and
$16.31 per share in 2005, 2004, and 2003, respectively. The options expire after ten years.
In connection with the distributor stock grants discussed above and the issuance of certain stock options to employees and distributors,
the Company incurred non-cash stock-based compensation representing the fair value of the stock and stock options granted to
distributors, and for employee stock options to the extent the fair value of the Company’s stock exceeded the exercise price of the
stock option at the date of the grant. The Company recognizes this non-cash stock-based compensation over the respective vesting
period, as appropriate. For the years ended
63
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2005, 2004 and 2003, non-cash stock-based expense of approximately $467,000 $1.5 million, and $2.1 million,
respectively, was recorded in the accompanying statement of operations related to these stock options and stock grants.
A summary of the Company’s stock options outstanding and exercisable at December 31, 2005, is as follows (shares in thousands):
Options Outstanding
Options Exercisable
Range of Exercise Prices
$ 0.00 – $8.50
$ 8.51 – $16.00
$16.01 – $24.00
$24.01 – $32.00
$32.01 – $35.87
Employee Stock Purchase Plan
Weighted-Average
Remaining
Contractual
Life
Weighted-
Average
Exercise
Price
$ 4.97
15.16
20.18
27.63
33.96
$ 19.55
Number
Exercisable
1,600
53
655
574
36
2,918
Weighted-
Average
Exercise
Price
$ 4.97
15.16
19.05
28.20
34.09
$ 13.24
4.5
6.7
7.6
8.5
8.4
7.2
Number
Outstanding
1,600
79
1,832
2,541
136
6,188
On May 30, 2002, the Company and its shareholders approved and adopted the 2002 Employee Stock Purchase Plan (the “ESPP”).
The ESPP authorizes the Company to issue up to 200,000 shares of common stock to its employees who work at least 20 hours per
week. Under the ESPP, there are two six-month plan periods during each calendar year, one beginning January 1 and ending on
June 30, and the other beginning July 1 and ending on December 31. Under the terms of the ESPP, employees can choose each plan
period to have up to 5% of their annual base earnings, limited to $5,000, withheld to purchase the Company’s common stock. The
purchase price of the stock is 85 percent of the lower of its beginning-of-period or end-of-period market price. Under the ESPP, the
Company sold to employees 11,530, 8,792, and 12,777 shares in 2005, 2004, and 2003, respectively. The weighted-average fair value
of those purchase rights granted in 2005, 2004, and 2003 was $6.93 per share, $9.04 per share, and $5.27 per share, respectively. As of
December 31, 2005, there were 161,219 shares available for future issuance. In applying the Black-Scholes methodology to the
purchase rights granted, the Company used the following assumptions:
Risk-free interest rate
Expected option life
Expected price volatility
2005
3.0% - 3.6%
6 months
39.8%
Year Ended December 31,
2004
1.9% - 2.8%
6 months
50.1%
2003
1.1% - 1.8%
6 months
54.3%
The assumed forfeiture rate was not material to the calculation. The Company does not assume a dividend yield as it has never
declared or paid cash dividends on its common stock.
14. Employee Benefit Plans:
The Company sponsors a defined contribution plan under Section 401(k) of the Internal Revenue Code, which covers U.S. employees
who are 21 years of age and over. Under this plan, the Company matches voluntary employee contributions at a rate of 100% for the
first 2% of an employee’s annual compensation and at a rate of 50% for the next 2% of an employee’s annual compensation.
Employees vest in the Company’s contributions after three years of service with the Company. The Company’s expense related to the
plan was approximately $940,000, $830,000, and $720,000 in 2005, 2004, and 2003, respectively.
64
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
15. Commitments and Contingencies:
Operating Leases. The Company leases certain equipment and office space under non-cancelable operating leases. Rental expense
under operating leases approximated $7.7 million, $6.2 million and $5.0 million for the years ended December 31, 2005, 2004, and
2003, respectively. Future minimum payments, by year and in the aggregate, under non-cancelable operating leases with initial or
remaining lease terms of one year or more, are as follows at December 31, 2005 (in thousands):
2006
2007
2008
2009
2010
Thereafter
$ 6,167
4,515
1,977
553
433
762
$14,407
Royalty and Consulting Agreements. The Company has entered into various royalty and other consulting agreements with third party
consultants. The Company incurred royalty and consulting expenses of $3.2 million, $5.2 million and $4.4 million during the years
ended December 31, 2005, 2004, and 2003, respectively, under minimum contractual obligations that were contingent upon services.
The amounts in the table below represent minimum payments to consultants that are contingent upon future services. These fees are
accrued when it is deemed probable that the performance thresholds are met. Payments under these agreements for which the
Company has not recorded a liability, are as follows at December 31, 2005 (in thousands):
2006
2007
2008
2009
2010
Thereafter
$ 3,369
431
430
430
330
1,327
$ 6,317
Portions of the Company’s payments for operating leases and royalty agreements are denominated in foreign currencies and were
translated in the tables above based on their respective U.S. dollar exchange rates at December 31, 2005. These future payments are
subject to foreign currency exchange rate risk.
Purchase Obligations. The Company has entered into certain supply agreements for its products, which include minimum purchase
obligations. During the years ended December 31, 2005, 2004, and 2003, the Company paid approximately $6.4 million, $6.4 million,
and $6.8 million, respectively, under those supply agreements. The Company’s remaining purchase obligations under those supply
agreements are approximately $5.2 million in 2006.
Portions of these payments are denominated in foreign currencies and were translated based on their respective U.S. dollar exchange
rates at December 31, 2005. These future payments are subject to foreign currency exchange rate risk.
Legal Proceedings. In 2002, pursuant to a purchase and royalty agreement with CERAbio LLC (“CERAbio”), the Company
purchased assets consisting primarily of completed technology for $3.0 million and recorded this entire amount as an intangible asset.
Of this purchase price, $1.5 million was paid upon signing the purchase agreement. The remaining $1.5 million is recorded in
“Accrued expenses and other current liabilities” in the consolidated balance sheet and is payable if certain conditions under the
agreement are satisfied. The agreement also provides for specified future royalties contingent upon sales of products related to the
acquired technology. Believing that the contractual obligations for payment had not been met, the Company disputed whether the
second payment and
65
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
royalties had been earned. In 2003, CERAbio and Phillips Plastics Corporation filed a lawsuit against the Company in United States
District Court for the Western District of Wisconsin for payment of the remaining $1.5 million purchase price and the royalties earned
to date. In 2003, the trial court ruled in favor of CERAbio and ordered the Company to pay the remaining purchase price and the
royalties earned to date. The royalties earned to date have been recorded within “Accrued expenses and other current liabilities” in the
consolidated balance sheet. In 2004, the Company appealed the trial court’s judgment to the United States Court of Appeals for the
Seventh Circuit. In June 2005, the appeals court upheld the trial court’s ruling granting CERAbio summary judgment on certain of the
Company’s counterclaims, but overruled the trial court’s ruling limiting the Company’s evidence that it could present at trial. The
effect of this ruling was to grant the Company a new trial in this dispute, the date for which has been set as May 8, 2006. The
Company does not believe that the outcome of this lawsuit will have a material adverse effect on its financial position or results of
operations.
In 2002, the Company entered into a license agreement to resolve an intellectual property dispute that, among other things, provided
for a payment of up to $1.25 million if a particular patent re-issued by February 10, 2004, and certain other conditions, as defined in
the license agreement, were satisfied. While the patent in question re-issued prior to February 10, 2004, based on its assessment, the
Company has concluded that the other required conditions were not satisfied upon re-issuance and the consequential payment of any
amount is not probable. On October 12, 2005, the licensor invoked the dispute resolution procedure set forth in the license agreement
which provides for a series of informal dispute resolution activities before a more formalized mechanism is invoked which could
ultimately lead to a formal arbitration proceeding and potentially an appeal to enforce the judgment of an arbitration panel. The
Company continues to believe that the required conditions were not satisfied upon reissuance, and therefore, no additional payment is
due as a result of the reissuance. Accordingly, no provision has been made for this contingency as of December 31, 2005.
In 2000, Howmedica Osteonics Corp. (“Howmedica”) sued the Company alleging patent infringement. The lawsuit seeks an order of
infringement, injunctive relief, unspecified damages and various other costs and relief and could impact a substantial portion of the
Company’s knee product line. The Company believes, however, that it has strong defenses against Howmedica’s claims and thus is
vigorously defending this lawsuit. In November 2005, the court issued a Markman ruling on claim construction holding that the
Company’s products do not literally infringe the claims of Howmedica’s patent. No trial date has been set in this matter. Management
is unable to estimate the potential liability, if any, with respect to the claims and accordingly, no provision has been made for this
contingency as of December 31, 2005. Management believes that the claims are covered in part by our patent infringement insurance.
Management does not believe that the outcome of this lawsuit will have a material adverse effect on the Company’s financial position
or results of operations.
In 2004, the Company announced a voluntary market withdrawal of a limited number of metal acetabular hip cups that are intended
for use in the Company’s CONSERVE ® hip systems. In connection with this market withdrawal, the Company recorded product
liability reserves for probable losses related to the market withdrawal. Management believes that the amount recorded is appropriate
based on assumptions with respect to estimated patient claims related to the market withdrawal. The nature of a market withdrawal
and the associated claims are such that the claims will occur over an extended period of time. The Company’s loss estimate includes
an assumption for unasserted claims based on management’s industry experience with similar circumstances. While the Company
believes that the amount recorded related to the market withdrawal is appropriate, it is possible that changes in assumptions related to
potential claims or insurance coverage could have an adverse effect on the Company’s estimate.
In 1993, prior to the December 1999 recapitalization and inception of the Company in its present form, the Predecessor Company
acquired substantially all of the assets of the large joint orthopaedic implant business from Dow Corning Corporation (DCC). DCC
retains liability for matters arising from certain conduct of DCC prior to June 30, 1993. As such, DCC has agreed to indemnify the
Predecessor Company against all liability for all products manufactured prior to the acquisition except for products provided under the
Predecessor Company’s 1993 agreement with DCC pursuant to which the Predecessor Company purchased certain small joint
orthopaedic
66
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
implants for worldwide distribution. The Predecessor Company was notified in 1995 that DCC, which filed for reorganization under
Chapter 11 of the U.S. Bankruptcy Code, would no longer defend the Predecessor Company in such matters until it received further
direction from the bankruptcy court. Based on the most recent plan of reorganization submitted to the court, it appears that the
Predecessor Company would be considered an unsecured creditor and, under the terms of the plan, would receive 24% of any such
claim as a cash payment with the remainder to be paid by a senior note due within ten years. There are several appeals regarding the
confirmed plan of reorganization pending before the U.S. District Court in Detroit, Michigan, which have delayed implementation of
the plan. There can be no assurance that DCC will indemnify the Predecessor Company or the Company on any claims in the future.
Although neither the Predecessor Company nor the Company maintains insurance for claims arising on products sold by DCC, the
Company does not believe the outcome of any of these matters will have a material adverse effect on the Company’s financial position
or results of operations.
In February 2006, a trial court in France delivered a ruling that requires the Company to pay approximately $1.5 million to one of its
French independent sales agents in satisfaction of a dispute, and that also returns control of the underlying sales territory back to the
Company. Both parties have the right to appeal this judgment, and the ultimate resolution of this dispute could be an amount higher or
lower than this amount. The Company has recorded approximately $1.5 million within “Accrued expenses and other current
liabilities” in the consolidated balance sheet. Management believes that the amount recorded is appropriate based on the facts and
circumstances of the underlying dispute. The Company does not believe that the ultimate resolution of this dispute will have a material
adverse effect on its financial position or results of operations.
The Company is currently involved in separate disputes in Italy with a former agent and two former employees. Management believes
that it has meritorious defenses to any claims related to these disputes. The payment of any amount related to these disputes is not
probable and cannot be estimated at this time. Accordingly, no provisions have been made for these matters as of December 31, 2005.
In addition to those noted above, the Company is subject to various other legal proceedings, product liability claims and other matters
which arise in the ordinary course of business. In the opinion of management, the amount of liability, if any, with respect to these
matters, will not materially affect the results of operations or financial position of the Company.
16. Segment Data:
The Company has one reportable segment, orthopaedic products, which includes the design, manufacture and marketing of
reconstructive joint devices and biologics products. The Company’s geographic regions consist of the United States, Europe (which
includes the Middle East and Africa) and Other (which principally represents Asia and Canada). Long-lived assets are those assets
located in each region. Revenues attributed to each region are based on the location in which the products were sold.
Net sales of orthopaedic products by category and information by geographic region are as follows (in thousands):
Net sales by product line:
Hips products
Knee products
Biologics products
Extremity products
Other
Total
2005
Year Ended December 31,
2004
2003
$109,267
94,073
62,358
40,594
12,845
$319,137
$ 99,133
87,408
62,070
36,433
12,495
$297,539
$ 78,071
78,338
50,056
31,876
10,591
$248,932
67
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Net sales by geographic region:
United States
Europe
Other
Total
Operating income (loss) by geographic region:
United States
Europe
Other
Total
Long-lived assets:
United States
Europe
Other
Total
2005
2004
2003
$197,548
80,374
41,215
$319,137
$ 32,464
(5,633)
6,650
$ 33,481
$180,380
84,726
32,433
$297,539
$ 31,209
3,535
3,669
$ 38,413
$152,864
70,078
25,990
$248,932
$ 18,772
7,110
1,284
$ 27,166
December 31,
2005
2004
$58,237
18,012
4,957
$81,206
$45,905
20,356
3,946
$70,207
No single foreign country accounted for more than 10% of the Company’s total net sales during 2005, 2004 or 2003; however, Italy
and France together represented approximately 12% of the Company’s total net sales in 2005, and 16% of the Company’s total net
sales in both 2004 and 2003.
During the year ended December 31, 2005, the Company’s European geographic region incurred charges of approximately $1.5
related to the write down of certain inventory due to the termination of an agreement to distribute certain third party spinal products in
Europe, charges of approximately $1.5 million associated with a European distributor transition and the associated legal dispute, and
charges of approximately $800,000 for severance costs associated with management changes.
17. Quarterly Results of Operations (unaudited):
The following table presents a summary of the Company’s unaudited quarterly operating results for each of the four quarters in 2005
and 2004, respectively (in thousands). This information was derived from unaudited interim financial statements that, in the opinion of
management, have been prepared on a basis consistent with the financial statements contained elsewhere in this filing and include all
adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of such information when read in
conjunction with our audited financial statements and related notes. The operating results for any quarter are not necessarily indicative
of results for any future period.
68
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Net sales
Cost of sales
Gross profit
Operating expenses:
Selling, general and administrative
Research and development
Amortization of intangible assets
Stock-based expense
Total operating expenses
Operating income
Net income
Net income per share, basic
Net income per share, diluted
Net sales
Cost of sales
Gross profit
Operating expenses:
Selling, general and administrative
Research and development
Amortization of intangible assets
Stock-based expense
Total operating expenses
Operating income
Net income
Net income per share, basic
Net income per share, diluted
First
Quarter
$82,601
22,777
59,824
41,668
4,897
1,059
212
47,836
$11,988
$ 7,269
0.21
$
0.21
$
First
Quarter
$74,917
20,386
54,531
37,134
4,982
942
424
43,482
$11,049
$ 6,614
0.20
$
0.19
$
2005
2004
Second
Quarter
$82,789
24,358
58,431
39,183
5,699
1,040
119
46,041
$12,390
$ 7,767
0.23
$
0.22
$
Second
Quarter
$75,616
21,383
54,233
37,714
4,524
928
465
43,631
$10,602
$ 6,688
0.20
$
0.19
$
Third
Quarter
$73,479
20,263
53,216
40,045
5,904
1,020
65
47,034
$ 6,182
$ 3,986
0.12
$
0.11
$
Third
Quarter
$69,299
19,998
49,301
36,611
4,302
975
271
42,159
$ 7,142
$ 4,430
0.13
$
0.13
$
Fourth
Quarter
$80,268
24,342
55,926
46,020
5,783
1,131
71
53,005
$ 2,921
$ 2,043
0.06
$
0.06
$
Fourth
Quarter
$77,707
22,416
55,291
39,685
4,613
1,044
329
45,671
$ 9,620
$ 6,290
0.19
$
0.18
$
The Company’s net income for the fourth quarter of 2005 included the after-tax effects of approximately $1.7 million of costs incurred
related to management changes in the Company’s U.S. and European operations, approximately $1.6 million of charges related to the
termination of an agreement to distribute certain third party spinal products in Europe, approximately $1.5 million of charges related
to a European distributor transition and the associated legal dispute, and approximately $700,000 of charges to write-down a
long-lived asset to its fair value.
The Company’s net income for the third quarter of 2004 included the after-tax effect of approximately $800,000 of costs associated
with the voluntary market withdrawal of certain CONSERVE® hip components. The Company’s net income for the fourth quarter of
2004 included the after-tax effect of approximately $2.9 million of charges associated with the Company’s foot and ankle product line
transition.
69
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Table of Contents
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Not applicable.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We have established disclosure controls and procedures that are designed to ensure that material information relating to us, including
our consolidated subsidiaries, is made known to our principal executive officer and principal financial officer by others within our
organization. Under the supervision and with the participation of our management, including our principal executive officer and
principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of
December 31, 2005. Based on this evaluation, our principal executive officer and principal financial officer concluded that our
disclosure controls and procedures were effective as of December 31, 2005, to ensure that the information required to be disclosed by
us in the reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported
within the time periods specified in the SEC’s rules and forms.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Under the
supervision and with the participation of our management, including our principal executive officer and principal financial officer, we
conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2005, based on the
criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO). Based on this evaluation, our management concluded that our internal control over financial
reporting was effective as of December 31, 2005. Our management’s assessment of the effectiveness of our internal control over
financial reporting as of December 31, 2005, has been audited by KPMG LLP, an independent registered public accounting firm, as
stated in their report which is included herein.
Item 9B. Other Information.
Not applicable.
70
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Table of Contents
Item 10. Directors and Executive Officers of the Registrant.
PART III
The information required by this item is incorporated by reference from the definitive proxy statement to be filed within 120 days after
December 31, 2005, pursuant to Regulation 14A under the Securities Exchange Act of 1934 in connection with the annual meeting of
stockholders to be held on May 11, 2006.
Item 11. Executive Compensation.
The information required by this item is incorporated by reference from the definitive proxy statement to be filed within 120 days after
December 31, 2005, pursuant to Regulation 14A under the Securities Exchange Act of 1934 in connection with the annual meeting of
stockholders to be held on May 11, 2006.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this item is incorporated by reference from the definitive proxy statement to be filed within 120 days after
December 31, 2005, pursuant to Regulation 14A under the Securities Exchange Act of 1934 in connection with the annual meeting of
stockholders to be held on May 11, 2006.
Item 13. Certain Relationships and Related Transactions.
The information required by this item is incorporated by reference from the definitive proxy statement to be filed within 120 days after
December 31, 2005, pursuant to Regulation 14A under the Securities Exchange Act of 1934 in connection with the annual meeting of
stockholders to be held on May 11, 2006.
Item 14. Principal Accountant Fees and Services.
The information required by this item is incorporated by reference from the definitive proxy statement to be filed within 120 days after
December 31, 2005, pursuant to Regulation 14A under the Securities Exchange Act of 1934 in connection with the annual meeting of
stockholders to be held on May 11, 2006.
71
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
PART IV
Item 15. Exhibits and Financial Statement Schedules.
Financial Statements
See Index to Consolidated Financial Statements in Item 8 of this report.
Financial Statement Schedules
See Schedule II — Valuation and Qualifying Accounts on page S-2 of this report.
Index to Exhibits
Exhibit No.
Description
2.1
2.2
3.1
3.2
4.1
4.2
4.3
Amended and Restated Agreement and Plan of Merger dated as of December 7, 1999, among Wright Medical
Technology, Inc., Warburg, Pincus Equity Partners, LP, Wright Acquisition Corp., Inc., and Wright Acquisition
Holdings, Inc. (now named Wright Medical Group, Inc.). (1)
ADCON Asset Purchase and Intellectual Property Assignment Agreement dated as of December 23, 2002, between
Wright Medical Technology, Inc. and Gliatech Inc., as amended by First Amendment to Asset Purchase and Intellectual
Property Assignment Agreement dated as of December 31, 2002, between Wright Medical Technology, Inc. and
Gliatech Inc.(2)
Fourth Amended and Restated Certificate of Incorporation of Wright Medical Group, Inc., (1) as amended by Certificate
of Amendment of Fourth Amended and Restated Certificate of Incorporation of Wright Medical Group, Inc. (3)
Amended and Restated By-laws of Wright Medical Group, Inc. (4)
Registration Rights Agreement dated December 7, 1999, among the investors listed on Schedule I thereto and Wright
Acquisition Holdings, Inc. (now named Wright Medical Group, Inc.). (1)
Investor Rights Agreement dated December 22, 1999, among the investors listed on Schedule I thereto, Warburg, Pincus
Equity Partners, L.P., and Wright Acquisition Holdings, Inc. (now named Wright Medical Group, Inc.). (1)
Stockholders Agreement dated December 7, 1999, among the stockholders, the investors listed on Schedule I thereto and
Wright Acquisition Holdings, Inc. (now named Wright Medical Group, Inc.), as amended by Amendment No. 1 to the
Stockholders Agreement, dated August 7, 2000, between the parties. (1)
4.4
Form of Common Stock certificate. (1)
10.1
Credit Agreement dated as of August 1, 2001, among Wright Medical Group, Inc., Wright Medical Technology, Inc., the
Lenders named therein, The Chase Manhattan Bank (now named JPMorgan Chase Bank), as Administrative Agent,
Collateral Agent and Issuing Bank, Credit Suisse First Boston, as Co-Syndication Agent, and U.S. Bank National
Association, as Co-Syndication Agent, (5) as amended by Amendment No. 1 to Credit Agreement dated as of July 31,
2002, among the parties thereto, (6) Amendment No. 2 to Credit Agreement dated as of May 23, 2003, among the parties
thereto, (6) and Amendment No. 3 to Credit Agreement dated as of September 11, 2003, among the parties thereto, (7)
and Amendment No. 4 to Credit Agreement dated as of December 3, 2004, (8) among the parties thereto, and
Amendment No. 5 to the Credit Agreement dated as of April 1, 2005, among the parties thereto. (9)
10.2
Fourth Amended and Restated 1999 Equity Incentive Plan (the “1999 Plan”). (10)
72
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Table of Contents
Exhibit No.
Description
10.3
Form of Incentive Stock Option Agreement, as amended by form of Amendment No. 1 to Incentive Stock Option
Agreement, pursuant to the 1999 Plan. (1)
10.4
Form of Non-Qualified Stock Option Agreement pursuant to the 1999 Plan. (1)
10.5
Form of Executive Stock Option Agreement pursuant to the 1999 Plan. (11)
10.6
Form of Non-Employee Director Stock Option Agreement pursuant to the 1999 Plan. (11)
10.7
Wright Medical Group, Inc. Executive Performance Incentive Plan. (12)
10.8
Form of Indemnification Agreement between Wright Medical Group, Inc. and its directors and executive officers. (1)
10.9
10.10
10.11
10.12
10.13
10.14
10.15
10.16
10.17
11
21
23
Employment Agreement dated as of July 1, 2004, between Wright Medical Technology, Inc. and Laurence Y. Fairey,
(13) as amended by First Amendment to Employment Agreement dated as of April 4, 2005. (9)
Employment Agreement dated as of April 25, 2005, between Wright Medical Technology, Inc. and R. Glen Coleman.
(11)
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc. and F. Barry Bays.
(14)
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc. and Jeffrey G.
Roberts. (14)
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc. and John K.
Bakewell. (14)
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc. and John R.
Treace.(14)
Severance and Release Agreement dated as of April 1, 2005, between Wright Medical Technology, Inc. and Brian T.
Ennis. (11)
Severance and Release Agreement dated as of October 5, 2005, between Wright Medical Technology, Inc. and Laurence
Y. Fairey. (15)
Severance and Release Agreement dated as of October 17, 2005, between Wright Medical Technology, Inc. and R. Glen
Coleman. (16)
Computation of earnings per share (included in Note 12 of the Notes to Consolidated Financial Statements (unaudited) in
Item 8 of this report).
Subsidiaries of Wright Medical Group, Inc.
Consent of KPMG LLP.
31.1
Certification of Chief Executive Officer Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934.
31.2
Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934.
32
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Rule 13a-14(b) Under the Securities
Exchange Act of 1934 and Section 1350 of Chapter 63 of Title 18 of the United States Code.
73
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Table of Contents
(1) Incorporated by reference to the Company’s Registration Statement on Form S-1 (Registration No. 333-59732), as amended.
(2) Incorporated by reference to the Company’s annual report on Form 10-K for the year ended December 31, 2002.
(3) Incorporated by reference to the Company’s Registration Statement on Form S-8 filed on May 14, 2004.
(4) Incorporated by reference to the Company’s current report on Form 8-K filed on March 31, 2004.
(5) Incorporated by reference to the Company’s current report on Form 8-K filed on August 3, 2001.
(6) Incorporated by reference to the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2003.
(7) Incorporated by reference to the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2003.
(8) Incorporated by reference to the Company’s current report on Form 8-K filed on December 7, 2004.
(9) Incorporated by reference to the Company’s current report on Form 8-K filed on April 7, 2005.
(10) Incorporated by reference to the Company’s definitive Proxy Statement on April 13, 2005.
(11) Incorporated by reference to the Company’s current report on Form 8-K filed on April 27, 2005.
(12) Incorporated by reference to the Company’s current report on Form 8-K filed on February 10, 2005.
(13) Incorporated by reference to the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2004.
(14) Incorporated by reference to the Company’s current report on Form 8-K filed on November 22, 2005.
(15) Incorporated by reference to the Company’s current report on Form 8-K filed on October 6, 2005.
(16) Incorporated by reference to the Company’s current report on Form 8-K filed on October 20, 2005.
74
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
February 28, 2006
WRIGHT MEDICAL GROUP, INC.
By:
/s/ F. Barry Bays
F. Barry Bays
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on
behalf of the registrant and in the capacities and on the dates indicated.
Signature
/s/ F. Barry Bays
F. Barry Bays
/s/ John K. Bakewell
John K. Bakewell
/s/ James T. Treace
James T. Treace
/s/ Richard B. Emmitt
Richard B. Emmitt
/s/ David D. Stevens
David D. Stevens
/s/ James E. Thomas
James E. Thomas
/s/ Thomas E. Timbie
Thomas E. Timbie
/s/ Elizabeth H. Weatherman
Elizabeth H. Weatherman
Title
Date
President, Chief Executive Officer and Director
(Principal Executive Officer)
February 28, 2006
Chief Financial Officer (Principal Financial
Officer and Principal Accounting Officer)
February 28, 2006
Executive Chairman of the Board
February 28, 2006
Director
Director
Director
Director
Director
75
February 28, 2006
February 28, 2006
February 28, 2006
February 28, 2006
February 28, 2006
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
The Board of Directors and Stockholders
Wright Medical Group, Inc.:
Report of Independent Registered Public Accounting Firm
Under date of February 27, 2006, we reported on the consolidated balance sheets of Wright Medical Group, Inc. and subsidiaries as of
December 31, 2005 and 2004, and the related consolidated statements of operations, changes in stockholders’ equity and
comprehensive income, and cash flows for each of the years in the three-year period ended December 31, 2005. These consolidated
financial statements, and our report thereon, are included in the annual report on Form 10-K for the year 2005. In connection with our
audits of the aforementioned consolidated financial statements, we also audited the related consolidated financial statement schedule
listed in Item 15 in the annual report on Form 10-K. The financial statement schedule is the responsibility of the Company’s
management. Our responsibility is to express an opinion on the financial statement schedule based on our audit.
In our opinion, the financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a
whole, present fairly, in all material respects, the information set forth therein.
(signed) KPMG LLP
Memphis, Tennessee
February 27, 2006
S-1
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
Table of Contents
Allowance for doubtful accounts:
For the period ended:
December 31, 2005
December 31, 2004
December 31, 2003
Sales returns and allowance:
For the period ended:
December 31, 2005
December 31, 2004
December 31, 2003
Wright Medical Group, Inc.
Schedule II-Valuation and Qualifying Accounts
(In thousands)
Balance
at
Beginning
of Period
Charged
to
Cost and
Expenses
Deductions
and Other
Balance
at
End of
Period
$ 1,820
$ 1,489
$ 1,509
$
$
$
510
268
87
$ (333)
(63)
$
107
$
$ 1,997
$ 1,820
$ 1,489
$
$
$
395
412
987
$
39
(17)
$
$ (101)
$ —
$ —
474
$
$
$
$
434
395
412
S-2
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
EXHIBIT 21
WRIGHT MEDICAL GROUP, INC.
LIST OF SUBSIDIARIES
1. Wright Medical Technology, Inc. (USA)
2. Wright Medical Capital, Inc. (USA)
3. Wright Medical Technology Canada Ltd. (Canada)
4. Wright Medical Japan, K.K. (Japan)
5. 2Hip Holdings SAS (France)
6. Wright Medical Europe SA (France)
7. Wright Medical Europe Trading SNC (France)
8. Wright Medical Europe Manufacturing SA (France)
9. Wright Medical France SAS (France)
10. Wright Medical Italy Srl (Italy)
11. Wright Medical UK Limited (UK)
12. Wright Medical Germany GmbH (Germany)
13. Cremascoli Ortho SA (Spain)
14. Wright Cremascoli Ortho NV (Belgium)
15. Wright Medical Netherlands, B.V. (Netherlands)
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
EXHIBIT 23
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors
Wright Medical Group, Inc.:
We consent to the incorporation by reference in the registration statements
(Nos. 333-75176, 333-90024, 333-108638, 333-115541, and 333-125231) on Form S-8
of Wright Medical Group, Inc. of our reports dated February 27, 2006, with
respect to the consolidated balance sheets of Wright Medical Group, Inc. as of
December 31, 2005 and 2004, and the related consolidated statements of
operations, changes in stockholders' equity and comprehensive income, and cash
flows for each of the years in the three-year period ended December 31, 2005,
and the financial statement schedule, management's assessment of the
effectiveness of internal control over financial reporting as of December 31,
2005 and the effectiveness of internal control over financial reporting as of
December 31, 2005, which reports appear in the December 31, 2005 annual report
on Form 10-K of Wright Medical Group, Inc.
(signed) KPMG LLP
Memphis, Tennessee
February 27, 2006
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO RULE 13a-14(a) UNDER
THE SECURITIES EXCHANGE ACT OF 1934
I, F. Barry Bays, certify that:
1. I have reviewed this annual report on Form 10-K for the year ended
December 31, 2005, of Wright Medical Group, Inc. (the "Company");
2. Based on my knowledge, this report does not contain any untrue statement
of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of
the Company as of, and for, the periods presented in this report;
4. The Company's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the Company and have:
(a) designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the
Company, including its consolidated subsidiaries, is made known to
us by others within those entities, particularly during the period
in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused
such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally
accepted accounting principles;
(c) evaluated the effectiveness of the Company's disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of the period covered by this report based on such evaluation;
and
(d) disclosed in this report any change in the Company's internal
control over financial reporting that occurred during the Company's
most recent fiscal quarter (the Company's fourth fiscal quarter in
the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the Company's internal
control over financial reporting; and
5. The Company's other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to
the Company's auditors and the audit committee of the Company's board of
directors:
(a) all significant deficiencies and material weaknesses in the design
or operation of internal control over financial reporting which are
reasonably likely to adversely affect the Company's ability to
record, process, summarize and report financial information; and
(b) any fraud, whether or not material, that involves management or
other employees who have a significant role in the Company's
internal control over financial reporting.
Date: February 28, 2006
/s/ F. Barry Bays
----------------------------------------
F. Barry Bays
President and Chief Executive Officer
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
EXHIBIT 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO RULE 13a-14(a) UNDER
THE SECURITIES EXCHANGE ACT OF 1934
I, John K. Bakewell, certify that:
1. I have reviewed this annual report on Form 10-K for the year ended
December 31, 2005, of Wright Medical Group, Inc. (the "Company");
2. Based on my knowledge, this report does not contain any untrue statement
of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of
the Company as of, and for, the periods presented in this report;
4. The Company's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the Company and have:
(a) designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the
Company, including its consolidated subsidiaries, is made known to
us by others within those entities, particularly during the period
in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused
such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally
accepted accounting principles;
(c) evaluated the effectiveness of the Company's disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of the period covered by this report based on such evaluation;
and
(d) disclosed in this report any change in the Company's internal
control over financial reporting that occurred during the Company's
most recent fiscal quarter (the Company's fourth fiscal quarter in
the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the Company's internal
control over financial reporting; and
5. The Company's other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to
the Company's auditors and the audit committee of the Company's board of
directors:
(a) all significant deficiencies and material weaknesses in the design
or operation of internal control over financial reporting which are
reasonably likely to adversely affect the Company's ability to
record, process, summarize and report financial information; and
(b) any fraud, whether or not material, that involves management or
other employees who have a significant role in the Company's
internal control over financial reporting.
Date: February 28, 2006
/s/ John K. Bakewell
----------------------------------
John K. Bakewell
Executive Vice President and Chief Financial Officer
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006
EXHIBIT 32
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND
CHIEF FINANCIAL OFFICER PURSUANT TO RULE 13a-14(b) UNDER
THE SECURITIES EXCHANGE ACT OF 1934 AND SECTION 1350 OF
CHAPTER 63 OF TITLE 18 OF THE UNITED STATES CODE
Each of the undersigned, F. Barry Bays and John K. Bakewell, certifies pursuant
to Rule 13a-14(b) under the Securities Exchange Act of 1934 (the "Exchange Act")
and Section 1350 of Chapter 63 of Title 18 of the United States Code, that (1)
this annual report on Form 10-K for the year ended December 31, 2005, of Wright
Medical Group, Inc. (the "Company") fully complies with the requirements of
Section 13(a) of the Exchange Act, and (2) the information contained in this
report fairly presents, in all material respects, the financial condition and
results of operations of the Company.
Date: February 28, 2006
/s/ F. Barry Bays
--------------------------------------------
F. Barry Bays
President and Chief Executive Officer
/s/ John K. Bakewell
----------------------------------------------
John K. Bakewell
Executive Vice President and Chief Financial Officer
_______________________________________________
Created by 10KWizard www.10KWizard.com
Source: WRIGHT MEDICAL GROUP, 10-K, March 01, 2006