WRIGHT MEDICAL GROUP, INC.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-K
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2005
OR
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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)
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Delaware
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13-4088127 |
(State or Other Jurisdiction
of Incorporation or Organization)
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(I.R.S. Employer
Identification No.) |
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5677 Airline Road, Arlington, Tennessee
(Address of Principal Executive Offices)
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38002
(Zip Code) |
Registrants 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.
o Yes þ 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.
o Yes þ 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. þ Yes o 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 registrants knowledge, in
definitive proxy or information statements incorporated by reference in Part III of this
Form 10-K
or any amendment to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
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 þ Accelerated filer o Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). o Yes þ No
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 registrants 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.
WRIGHT MEDICAL GROUP, INC.
ANNUAL REPORT ON FORM 10-K
Table of Contents
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Safe-Harbor Statement
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 managements current knowledge,
assumptions, beliefs, estimates, and expectations and express managements 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.
PART I
Item 1. Business.
Overview
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 companys 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 Cremascolis strength in hip reconstruction with the predecessor
companys 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.
1
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 implants life and increase conservation of the patients 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 patients
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 bodys 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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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 patients 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 FDAs 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 manufacturers 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 FDAs IDE regulations and informed consent must be obtained from
each subject. If the FDA believes we are not in compliance
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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 donors 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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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
patients 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 Implants 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 patients 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 patients 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 physicians 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 patients
anatomical requirements as well as the surgeons preferences. This product allows surgeons the
flexibility to match the implant to each patients 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 patients 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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IGNITEÒ 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 IGNITEÒ 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.
ADCONÒ Gel products are designed to reduce adhesion (scar) formation following
lumbar spine (ADCONÒ-L Gel) and peripheral tendon/nerve
(ADCONÒ-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 ADCONÒ 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
ADCONÒ 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
GRAFTJACKETÒ 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:
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obtain regulatory clearance and compliance for our products; |
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manufacture and sell our products cost-effectively; |
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meet all relevant quality standards for our products and their markets; |
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respond to competitive pressures specific to each of our geographic markets,
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protect the proprietary technology of our products and manufacturing processes; |
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market our products; |
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attract and retain skilled employees and sales representatives; and |
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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
patients 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 patients 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
patients 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:
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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 donors 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
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
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 Howmedicas 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.
17
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:
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the imposition of additional foreign governmental controls or regulations on orthopaedic implants and biologics
products; |
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new export license requirements, particularly related to our biologics products; |
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economic instability, including currency risk between the U.S. dollar and foreign currencies, in our target markets; |
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a shortage of high-quality international salespeople and distributors; |
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loss of any key personnel who possess proprietary knowledge or are otherwise important to our success in international
markets; |
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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; |
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changes in tariffs and other trade restrictions, particularly related to the exportation of our biologics products; |
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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; |
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a shortage of nurses in some of our target markets, particularly affecting our operations in France; and |
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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:
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lack of clinical acceptance of allograft products and related technologies; |
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the introduction of competitive tissue repair treatment options that render allograft products and technologies too
expensive and obsolete; |
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lack of available third-party reimbursement; |
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the inability to train surgeons in the use of allograft products and technologies; |
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the risk of disease transmission; and |
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ethical concerns about the commercial aspects of harvesting cadaveric tissue. |
18
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.
19
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.
20
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:
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difficulties in integrating any acquired companies, personnel and products into our existing business; |
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delays in realizing the benefits of the acquired company or products; |
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diversion of our managements time and attention from other business concerns; |
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limited or no direct prior experience in new markets or countries we may enter; |
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higher costs of integration than we anticipated; or |
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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:
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demand for products, which historically has been lowest in the third quarter; |
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our ability to meet the demand for our products; |
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the number, timing and significance of new products and product introductions and enhancements by us and our
competitors; |
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our ability to develop, introduce and market new and enhanced versions of our products on a timely basis; |
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changes in pricing policies by us and our competitors; |
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changes in the treatment practices of orthopaedic surgeons; |
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changes in distributor relationships and sales force size and composition; |
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the timing of material expense- or income-generating events and the related recognition of their associated
financial impact; |
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the timing of significant orders and shipments; |
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availability of raw materials; |
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work stoppages or strikes in the health care industry; |
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changes in FDA and foreign governmental regulatory policies, requirements and enforcement practices; |
21
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changes in accounting policies, estimates, and treatments; and |
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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
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
Howmedicas 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 Howmedicas 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 Howmedicas 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
$1.5 million purchase price and the royalties earned to date. In 2003, the trial court ruled in
favor of CERAbio and ordered us to pay the remaining purchase price and the royalties earned to
date. The royalties earned to date have been recorded within Accrued expenses and other current
liabilities in the consolidated balance sheet. In 2004, we appealed the trial courts judgment to
the United States Court of Appeals for the Seventh Circuit. In June 2005, the appeals court upheld
the trial courts ruling granting CERAbio summary judgment on certain of our counterclaims, but
overruled the trial courts ruling limiting our evidence that we could present at trial. The effect
of this ruling was to grant us a new trial in this dispute, the date for which has been set as May
8, 2006. We do not believe that the outcome of this lawsuit will have a material adverse effect on
our financial position or results of operations.
Item 4. Submission of Matters to a Vote of Security Holders.
Not applicable.
23
PART II
Item 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities.
Market Information
Our common stock is traded on the Nasdaq National Market under the symbol WMGI. The following
table sets forth, for the periods indicated, the high and low bid prices per share of our common
stock as reported on the Nasdaq National Market.
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High |
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Low |
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Fiscal Year 2005 |
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First Quarter |
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$ |
27.62 |
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$ |
24.00 |
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Second Quarter |
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$ |
27.97 |
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$ |
22.98 |
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Third Quarter |
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$ |
28.40 |
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$ |
23.93 |
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Fourth Quarter |
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$ |
24.39 |
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$ |
18.30 |
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Fiscal Year 2004 |
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First Quarter |
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$ |
35.53 |
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$ |
29.24 |
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Second Quarter |
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$ |
36.99 |
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$ |
29.56 |
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Third Quarter |
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$ |
36.08 |
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$ |
22.90 |
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Fourth Quarter |
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$ |
30.10 |
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$ |
20.75 |
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Holders
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
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.
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Year Ended December 31, |
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2005 |
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2004 |
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2003 |
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2002 |
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2001 |
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Statement of Operations: |
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|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
319,137 |
|
|
$ |
297,539 |
|
|
$ |
248,932 |
|
|
$ |
200,873 |
|
|
$ |
172,921 |
|
Cost of sales |
|
|
91,740 |
|
|
|
84,183 |
|
|
|
67,815 |
|
|
|
55,616 |
|
|
|
51,351 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
227,397 |
|
|
|
213,356 |
|
|
|
181,117 |
|
|
|
145,257 |
|
|
|
121,570 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
|
166,916 |
|
|
|
151,144 |
|
|
|
127,612 |
|
|
|
106,875 |
|
|
|
95,556 |
|
Research and development |
|
|
22,283 |
|
|
|
18,421 |
|
|
|
16,151 |
|
|
|
10,357 |
|
|
|
10,108 |
|
Amortization of intangible assets (2) |
|
|
4,250 |
|
|
|
3,889 |
|
|
|
3,562 |
|
|
|
3,946 |
|
|
|
5,349 |
|
Stock-based expense (3) |
|
|
467 |
|
|
|
1,489 |
|
|
|
2,068 |
|
|
|
1,724 |
|
|
|
1,996 |
|
Acquired in-process research and development costs |
|
|
|
|
|
|
|
|
|
|
4,558 |
|
|
|
|
|
|
|
|
|
Arbitration settlement award |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,200 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
193,916 |
|
|
|
174,943 |
|
|
|
153,951 |
|
|
|
118,702 |
|
|
|
113,009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
33,481 |
|
|
|
38,413 |
|
|
|
27,166 |
|
|
|
26,555 |
|
|
|
8,561 |
|
Interest (income) expense, net |
|
|
(176 |
) |
|
|
1,064 |
|
|
|
1,107 |
|
|
|
938 |
|
|
|
7,809 |
|
Other expense (income), net |
|
|
237 |
|
|
|
(74 |
) |
|
|
(1,060 |
) |
|
|
(1,277 |
) |
|
|
685 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
33,420 |
|
|
|
37,423 |
|
|
|
27,119 |
|
|
|
26,894 |
|
|
|
67 |
|
Provision for income taxes |
|
|
12,355 |
|
|
|
13,401 |
|
|
|
9,722 |
|
|
|
1,834 |
|
|
|
1,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
21,065 |
|
|
$ |
24,022 |
|
|
$ |
17,397 |
|
|
$ |
25,060 |
|
|
$ |
(1,507 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: (4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.62 |
|
|
$ |
0.72 |
|
|
$ |
0.53 |
|
|
$ |
0.79 |
|
|
$ |
(0.31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.60 |
|
|
$ |
0.68 |
|
|
$ |
0.50 |
|
|
$ |
0.75 |
|
|
$ |
(0.31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding -
basic |
|
|
33,959 |
|
|
|
33,391 |
|
|
|
32,857 |
|
|
|
31,870 |
|
|
|
13,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding -
diluted |
|
|
35,199 |
|
|
|
35,317 |
|
|
|
34,561 |
|
|
|
33,550 |
|
|
|
13,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
|
2001 |
|
Consolidated Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
51,277 |
|
|
$ |
83,470 |
|
|
$ |
66,571 |
|
|
$ |
51,373 |
|
|
$ |
2,770 |
|
Working capital |
|
|
196,126 |
|
|
|
189,803 |
|
|
|
147,255 |
|
|
|
127,557 |
|
|
|
47,546 |
|
Total assets |
|
|
371,810 |
|
|
|
361,158 |
|
|
|
322,103 |
|
|
|
276,370 |
|
|
|
193,719 |
|
Long-term liabilities |
|
|
15,547 |
|
|
|
19,870 |
|
|
|
20,516 |
|
|
|
25,939 |
|
|
|
30,967 |
|
Stockholders equity |
|
$ |
292,008 |
|
|
$ |
276,069 |
|
|
$ |
238,318 |
|
|
$ |
204,999 |
|
|
|
$117,300 |
|
25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
|
2001 |
|
Other Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow provided by operating activities |
|
$ |
5,291 |
|
|
$ |
37,365 |
|
|
$ |
40,065 |
|
|
$ |
21,950 |
|
|
$ |
818 |
|
Cash flow used in investing activities |
|
|
(31,583 |
) |
|
|
(18,428 |
) |
|
|
(25,844 |
) |
|
|
(22,430 |
) |
|
|
(15,558 |
) |
Cash flow (used in) provided by financing activities |
|
|
(5,379 |
) |
|
|
(2,305 |
) |
|
|
514 |
|
|
|
48,384 |
|
|
|
1,372 |
|
Depreciation |
|
|
17,895 |
|
|
|
17,278 |
|
|
|
13,948 |
|
|
|
13,553 |
|
|
|
10,096 |
|
Amortization of intangible assets (2) |
|
|
4,250 |
|
|
|
3,889 |
|
|
|
3,562 |
|
|
|
3,946 |
|
|
|
5,349 |
|
Capital expenditures |
|
$ |
30,356 |
|
|
$ |
18,316 |
|
|
$ |
18,116 |
|
|
$ |
17,974 |
|
|
$ |
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
Item 7. Managements Discussion and Analysis of Financial Condition and Results of
Operations.
The following managements 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
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 ADCONÒ 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
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 FDAs 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 FDAs 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
Companys 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
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 managements 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
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
Amount |
|
|
Sales |
|
|
Amount |
|
|
Sales |
|
Net sales |
|
$ |
319,137 |
|
|
|
100.0 |
% |
|
$ |
297,539 |
|
|
|
100.0 |
% |
Cost of sales |
|
|
91,740 |
|
|
|
28.7 |
% |
|
|
84,183 |
|
|
|
28.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
227,397 |
|
|
|
71.3 |
% |
|
|
213,356 |
|
|
|
71.7 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
166,916 |
|
|
|
52.3 |
% |
|
|
151,144 |
|
|
|
50.8 |
% |
Research and development |
|
|
22,283 |
|
|
|
7.0 |
% |
|
|
18,421 |
|
|
|
6.2 |
% |
Amortization of intangible assets |
|
|
4,250 |
|
|
|
1.3 |
% |
|
|
3,889 |
|
|
|
1.3 |
% |
Stock-based expense |
|
|
467 |
|
|
|
0.1 |
% |
|
|
1,489 |
|
|
|
0.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
193,916 |
|
|
|
60.8 |
% |
|
|
174,943 |
|
|
|
58.8 |
% |
|
Operating income |
|
|
33,481 |
|
|
|
10.5 |
% |
|
|
38,413 |
|
|
|
12.9 |
% |
|
Interest (income) expense, net |
|
|
(176 |
) |
|
|
(0.1 |
)% |
|
|
1,064 |
|
|
|
0.4 |
% |
Other expense (income), net |
|
|
237 |
|
|
|
0.1 |
% |
|
|
(74 |
) |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
33,420 |
|
|
|
10.5 |
% |
|
|
37,423 |
|
|
|
12.6 |
% |
Provision for income taxes |
|
|
12,355 |
|
|
|
3.9 |
% |
|
|
13,401 |
|
|
|
4.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
21,065 |
|
|
|
6.6 |
% |
|
$ |
24,022 |
|
|
|
8.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
Year Ended |
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
% |
|
|
|
2005 |
|
|
2004 |
|
|
Change |
|
Hip products |
|
$ |
109,267 |
|
|
$ |
99,133 |
|
|
|
10.2 |
% |
Knee products |
|
|
94,073 |
|
|
|
87,408 |
|
|
|
7.6 |
% |
Biologics products |
|
|
62,358 |
|
|
|
62,070 |
|
|
|
0.5 |
% |
Extremity products |
|
|
40,594 |
|
|
|
36,433 |
|
|
|
11.4 |
% |
Other |
|
|
12,845 |
|
|
|
12,495 |
|
|
|
2.8 |
% |
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
319,137 |
|
|
$ |
297,539 |
|
|
|
7.3 |
% |
|
|
|
|
|
|
|
|
|
|
31
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
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
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2004 |
|
|
2003 |
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
Amount |
|
|
Sales |
|
|
Amount |
|
|
Sales |
|
Net sales |
|
$ |
297,539 |
|
|
|
100.0 |
% |
|
$ |
248,932 |
|
|
|
100.0 |
% |
Cost of sales |
|
|
84,183 |
|
|
|
28.3 |
% |
|
|
67,815 |
|
|
|
27.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
213,356 |
|
|
|
71.7 |
% |
|
|
181,117 |
|
|
|
72.8 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
151,144 |
|
|
|
50.8 |
% |
|
|
127,612 |
|
|
|
51.3 |
% |
Research and development |
|
|
18,421 |
|
|
|
6.2 |
% |
|
|
16,151 |
|
|
|
6.5 |
% |
Amortization of intangible assets |
|
|
3,889 |
|
|
|
1.3 |
% |
|
|
3,562 |
|
|
|
1.4 |
% |
Stock-based expense |
|
|
1,489 |
|
|
|
0.5 |
% |
|
|
2,068 |
|
|
|
0.8 |
% |
Acquired in-process research and
development costs |
|
|
|
|
|
|
|
|
|
|
4,558 |
|
|
|
1.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
174,943 |
|
|
|
58.8 |
% |
|
|
153,951 |
|
|
|
61.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
38,413 |
|
|
|
12.9 |
% |
|
|
27,166 |
|
|
|
10.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
1,064 |
|
|
|
0.4 |
% |
|
|
1,107 |
|
|
|
0.4 |
% |
Other income, net |
|
|
(74 |
) |
|
|
0.0 |
% |
|
|
(1,060 |
) |
|
|
(0.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
37,423 |
|
|
|
12.6 |
% |
|
|
27,119 |
|
|
|
10.9 |
% |
Provision for income taxes |
|
|
13,401 |
|
|
|
4.5 |
% |
|
|
9,722 |
|
|
|
3.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
24,022 |
|
|
|
8.1 |
% |
|
$ |
17,397 |
|
|
|
7.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
Year Ended |
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
% |
|
|
|
2004 |
|
|
2003 |
|
|
Change |
|
Hip products |
|
$ |
99,133 |
|
|
$ |
78,071 |
|
|
|
27.0 |
% |
Knee products |
|
|
87,408 |
|
|
|
78,338 |
|
|
|
11.6 |
% |
Biologics products |
|
|
62,070 |
|
|
|
50,056 |
|
|
|
24.0 |
% |
Extremity products |
|
|
36,433 |
|
|
|
31,876 |
|
|
|
14.3 |
% |
Other |
|
|
12,495 |
|
|
|
10,591 |
|
|
|
18.0 |
% |
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
297,539 |
|
|
$ |
248,932 |
|
|
|
19.5 |
% |
|
|
|
|
|
|
|
|
|
|
34
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
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 managements 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 |
|
Discount rate including |
|
|
|
|
expected to |
|
factor to account for |
|
|
Project |
|
begin |
|
uncertainty of success |
|
Acquired IPRD |
ADCON® Gel |
|
|
2004 |
|
|
|
32.3 |
% |
|
$ |
4,558,000 |
|
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.
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
Liquidity and Capital Resources
The following table sets forth, for the periods indicated, certain liquidity measures (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2005 |
|
2004 |
Cash and cash equivalents |
|
$ |
51,277 |
|
|
$ |
83,470 |
|
Short-term marketable securities |
|
|
25,000 |
|
|
|
|
|
Working capital |
|
|
196,126 |
|
|
|
189,803 |
|
Line of credit availability |
|
|
59,878 |
|
|
|
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
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):
|
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|
|
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|
|
|
|
|
Payments Due by Periods |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009- |
|
|
After |
|
|
|
Total |
|
|
2006 |
|
|
2007-2008 |
|
|
2010 |
|
|
2010 |
|
Amounts reflected in balance sheet: |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
3,750 |
|
|
$ |
3,750 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Capital lease obligations (1) |
|
|
3,858 |
|
|
|
2,008 |
|
|
|
1,578 |
|
|
|
266 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts not reflected in balance sheet: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases |
|
|
14,407 |
|
|
|
6,167 |
|
|
|
6,492 |
|
|
|
986 |
|
|
|
762 |
|
Purchase obligations |
|
|
5,160 |
|
|
|
5,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty and consulting agreements |
|
|
6,317 |
|
|
|
3,369 |
|
|
|
861 |
|
|
|
760 |
|
|
|
1,327 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations |
|
$ |
33,492 |
|
|
$ |
20,454 |
|
|
$ |
8,931 |
|
|
$ |
2,012 |
|
|
$ |
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
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
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 Companys receivables are from hospitals, many of which are government funded.
Accordingly, the Companys 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
customers 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
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 assets 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 managements 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
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 facilitys 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
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
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
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45 |
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CONSOLIDATED FINANCIAL STATEMENTS |
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47 |
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48 |
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49 |
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50 |
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51 |
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44
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Wright Medical Group, Inc.:
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 Companys 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 managements assessment of, and the effective operation of, internal control over financial
reporting.
(signed) KPMG LLP
Memphis, Tennessee
February 27, 2006
45
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Wright Medical Group, Inc.:
We have audited managements assessment, included in the accompanying Managements 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 ControlIntegrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO). The Companys 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 managements assessment and an opinion on the effectiveness of the Companys 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 managements 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 companys 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
companys 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 companys 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, managements 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 ControlIntegrated 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 ControlIntegrated 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
Wright Medical Group, Inc.
Consolidated Balance Sheets
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Assets: |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
51,277 |
|
|
$ |
83,470 |
|
Marketable securities |
|
|
25,000 |
|
|
|
|
|
Accounts receivable, net |
|
|
61,729 |
|
|
|
61,662 |
|
Inventories |
|
|
82,381 |
|
|
|
76,269 |
|
Prepaid expenses |
|
|
11,025 |
|
|
|
4,822 |
|
Deferred income taxes |
|
|
24,218 |
|
|
|
24,082 |
|
Other current assets |
|
|
4,751 |
|
|
|
4,717 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
260,381 |
|
|
|
255,022 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
81,206 |
|
|
|
70,207 |
|
Goodwill |
|
|
7,829 |
|
|
|
8,845 |
|
Intangible assets, net |
|
|
12,724 |
|
|
|
17,140 |
|
Deferred income taxes |
|
|
8,217 |
|
|
|
8,873 |
|
Other assets |
|
|
1,453 |
|
|
|
1,071 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
371,810 |
|
|
$ |
361,158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity: |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
13,572 |
|
|
$ |
13,969 |
|
Accrued expenses and other current liabilities |
|
|
45,055 |
|
|
|
44,919 |
|
Current portion of long-term obligations |
|
|
5,628 |
|
|
|
6,331 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
64,255 |
|
|
|
65,219 |
|
Long-term obligations |
|
|
1,728 |
|
|
|
5,952 |
|
Deferred income taxes |
|
|
151 |
|
|
|
26 |
|
Other liabilities |
|
|
13,668 |
|
|
|
13,892 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
79,802 |
|
|
|
85,089 |
|
|
|
|
|
|
|
|
|
|
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 |
|
|
342 |
|
|
|
339 |
|
Additional paid-in capital |
|
|
274,312 |
|
|
|
269,944 |
|
Deferred compensation |
|
|
|
|
|
|
(188 |
) |
Accumulated other comprehensive income |
|
|
11,957 |
|
|
|
21,642 |
|
Accumulated income (deficit) |
|
|
5,397 |
|
|
|
(15,668 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
292,008 |
|
|
|
276,069 |
|
|
|
|
|
|
|
|
|
|
$ |
371,810 |
|
|
$ |
361,158 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
47
Wright Medical Group, Inc.
Consolidated Statements of Operations
(In thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Net sales |
|
$ |
319,137 |
|
|
$ |
297,539 |
|
|
$ |
248,932 |
|
Cost of sales |
|
|
91,740 |
|
|
|
84,183 |
|
|
|
67,815 |
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
227,397 |
|
|
|
213,356 |
|
|
|
181,117 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
166,916 |
|
|
|
151,144 |
|
|
|
127,612 |
|
Research and development |
|
|
22,283 |
|
|
|
18,421 |
|
|
|
16,151 |
|
Amortization of intangible assets |
|
|
4,250 |
|
|
|
3,889 |
|
|
|
3,562 |
|
Stock-based expense1 |
|
|
467 |
|
|
|
1,489 |
|
|
|
2,068 |
|
Acquired in-process research and development costs |
|
|
|
|
|
|
|
|
|
|
4,558 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
193,916 |
|
|
|
174,943 |
|
|
|
153,951 |
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
33,481 |
|
|
|
38,413 |
|
|
|
27,166 |
|
Interest (income) expense, net |
|
|
(176 |
) |
|
|
1,064 |
|
|
|
1,107 |
|
Other expense (income), net |
|
|
237 |
|
|
|
(74 |
) |
|
|
(1,060 |
) |
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
33,420 |
|
|
|
37,423 |
|
|
|
27,119 |
|
Provision for income taxes |
|
|
12,355 |
|
|
|
13,401 |
|
|
|
9,722 |
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
21,065 |
|
|
$ |
24,022 |
|
|
$ |
17,397 |
|
|
|
|
|
|
|
|
|
|
|
Net income per share (Note 12): |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.62 |
|
|
$ |
0.72 |
|
|
$ |
0.53 |
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.60 |
|
|
$ |
0.68 |
|
|
$ |
0.50 |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of shares outstanding basic |
|
|
33,959 |
|
|
|
33,391 |
|
|
|
32,857 |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of shares outstanding diluted |
|
|
35,199 |
|
|
|
35,317 |
|
|
|
34,561 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
Amounts presented as non-cash stock-based
expense consist of the following for the periods indicated: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Cost of sales |
|
$ |
12 |
|
|
$ |
68 |
|
|
$ |
107 |
|
Selling, general and administrative |
|
|
449 |
|
|
|
1,364 |
|
|
|
1,875 |
|
Research and development |
|
|
6 |
|
|
|
57 |
|
|
|
86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
467 |
|
|
$ |
1,489 |
|
|
$ |
2,068 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
48
Wright Medical Group, Inc.
Consolidated Statements of Cash Flows
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
21,065 |
|
|
$ |
24,022 |
|
|
$ |
17,397 |
|
Adjustments to reconcile net income to net cash
provided by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
17,895 |
|
|
|
17,278 |
|
|
|
13,948 |
|
Amortization of deferred financing costs |
|
|
262 |
|
|
|
261 |
|
|
|
261 |
|
Amortization of intangible assets |
|
|
4,250 |
|
|
|
3,889 |
|
|
|
3,562 |
|
Deferred income taxes |
|
|
(329 |
) |
|
|
5,068 |
|
|
|
4,565 |
|
Stock-based expenses |
|
|
467 |
|
|
|
1,489 |
|
|
|
2,068 |
|
In-process research and development costs |
|
|
|
|
|
|
|
|
|
|
4,558 |
|
Other |
|
|
1,386 |
|
|
|
623 |
|
|
|
275 |
|
Changes in assets and liabilities, net of acquisitions: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(5,177 |
) |
|
|
(3,811 |
) |
|
|
(11,359 |
) |
Inventories |
|
|
(9,364 |
) |
|
|
(7,861 |
) |
|
|
(3,466 |
) |
Marketable securities |
|
|
(25,000 |
) |
|
|
|
|
|
|
|
|
Other current assets |
|
|
(6,062 |
) |
|
|
(3,223 |
) |
|
|
(676 |
) |
Accounts payable |
|
|
647 |
|
|
|
(849 |
) |
|
|
3,153 |
|
Accrued expenses and other liabilities |
|
|
5,251 |
|
|
|
479 |
|
|
|
5,779 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
5,291 |
|
|
|
37,365 |
|
|
|
40,065 |
|
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(30,356 |
) |
|
|
(18,316 |
) |
|
|
(18,116 |
) |
Purchase of tangible and intangible assets (Note 3) |
|
|
(1,227 |
) |
|
|
(161 |
) |
|
|
(7,799 |
) |
Other |
|
|
|
|
|
|
49 |
|
|
|
71 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(31,583 |
) |
|
|
(18,428 |
) |
|
|
(25,844 |
) |
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock |
|
|
2,930 |
|
|
|
4,056 |
|
|
|
1,678 |
|
Financing under factoring agreements, net |
|
|
(1,208 |
) |
|
|
(29 |
) |
|
|
4,680 |
|
Payments of bank and other financing |
|
|
(7,101 |
) |
|
|
(6,332 |
) |
|
|
(5,844 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(5,379 |
) |
|
|
(2,305 |
) |
|
|
514 |
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
(522 |
) |
|
|
267 |
|
|
|
463 |
|
Net (decrease) increase in cash and cash equivalents |
|
|
(32,193 |
) |
|
|
16,899 |
|
|
|
15,198 |
|
Cash and cash equivalents, beginning of period |
|
|
83,470 |
|
|
|
66,571 |
|
|
|
51,373 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
51,277 |
|
|
$ |
83,470 |
|
|
$ |
66,571 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
49
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Accumulated |
|
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Number of |
|
|
|
|
|
|
Paid-in |
|
|
(Deficit) |
|
|
Deferred |
|
|
Comprehensive |
|
|
Stockholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income |
|
|
Compensation |
|
|
Income |
|
|
Equity |
|
|
|
|
|
|
Balance at December 31, 2002 |
|
|
32,712,374 |
|
|
$ |
327 |
|
|
$ |
260,640 |
|
|
$ |
(57,087 |
) |
|
$ |
(3,164 |
) |
|
$ |
4,283 |
|
|
$ |
204,999 |
|
2003 Activity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,397 |
|
|
|
|
|
|
|
|
|
|
|
17,397 |
|
Foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,392 |
|
|
|
11,392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,789 |
|
Issuance of common stock,
net of costs |
|
|
328,373 |
|
|
|
3 |
|
|
|
1,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,678 |
|
Tax benefit of employee
stock option exercises |
|
|
|
|
|
|
|
|
|
|
784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
784 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
593 |
|
|
|
|
|
|
|
1,475 |
|
|
|
|
|
|
|
2,068 |
|
Forfeiture of stock options |
|
|
|
|
|
|
|
|
|
|
(237 |
) |
|
|
|
|
|
|
237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003 |
|
|
33,040,747 |
|
|
$ |
330 |
|
|
$ |
263,455 |
|
|
$ |
(39,690 |
) |
|
$ |
(1,452 |
) |
|
$ |
15,675 |
|
|
$ |
238,318 |
|
|
|
|
|
|
2004 Activity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,022 |
|
|
|
|
|
|
|
|
|
|
|
24,022 |
|
Foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,967 |
|
|
|
5,967 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,989 |
|
Issuance of common stock,
net of costs |
|
|
809,455 |
|
|
|
9 |
|
|
|
4,047 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,056 |
|
Tax benefit of employee
stock option exercises |
|
|
|
|
|
|
|
|
|
|
2,217 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,217 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
331 |
|
|
|
|
|
|
|
1,158 |
|
|
|
|
|
|
|
1,489 |
|
Forfeiture of stock options |
|
|
|
|
|
|
|
|
|
|
(106 |
) |
|
|
|
|
|
|
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004 |
|
|
33,850,202 |
|
|
$ |
339 |
|
|
$ |
269,944 |
|
|
$ |
(15,668 |
) |
|
$ |
(188 |
) |
|
$ |
21,642 |
|
|
$ |
276,069 |
|
|
|
|
|
|
2005 Activity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,065 |
|
|
|
|
|
|
|
|
|
|
|
21,065 |
|
Foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,685 |
) |
|
|
(9,685 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,380 |
|
Issuance of common stock,
net of costs |
|
|
325,494 |
|
|
|
3 |
|
|
|
2,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,930 |
|
Tax benefit of employee
stock option exercises |
|
|
|
|
|
|
|
|
|
|
1,162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,162 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
288 |
|
|
|
|
|
|
|
179 |
|
|
|
|
|
|
|
467 |
|
Forfeiture of stock options |
|
|
|
|
|
|
|
|
|
|
(9 |
) |
|
|
|
|
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 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
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 Companys 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 Companys 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 Companys 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 Companys review of inventory for excess
51
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 Companys
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 Companys 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 Companys 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 |
|
|
15 to 25 years |
|
Buildings |
|
|
10 to 45 years |
|
Machinery and equipment |
|
|
3 to 20 years |
|
Furniture, fixtures and office equipment |
|
|
1 to 14 years |
|
Surgical instruments |
|
|
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 Companys 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 Companys 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
Companys 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
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 Companys 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 Companys receivables are from hospitals, many of which are government funded.
Accordingly, the Companys 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
customers non-response to collection efforts. The Companys 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 Companys products. The Companys 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 Companys 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 Companys hip
products. In addition, for the Companys 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 Companys 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 Companys
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
Companys consolidated balance sheet.
Revenue Recognition. The Companys revenues are generated through two types of customers, hospitals
and stocking distributors, with the majority of the Companys revenue derived from sales to
hospitals. The Companys 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 Companys 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
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 Companys 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 Companys 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
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Net income, as reported |
|
$ |
21,065 |
|
|
$ |
24,022 |
|
|
$ |
17,397 |
|
Add: Stock-based employee
compensation cost
recognized under intrinsic
value method, net of tax
effects |
|
|
151 |
|
|
|
681 |
|
|
|
920 |
|
Less: Stock-based employee
compensation expense
determined under fair value
based method, net of tax
effects |
|
|
(12,972 |
) |
|
|
(8,626 |
) |
|
|
(4,334 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net income |
|
$ |
8,244 |
|
|
$ |
16,077 |
|
|
$ |
13,983 |
|
|
|
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic, as reported |
|
$ |
0.62 |
|
|
$ |
0.72 |
|
|
$ |
0.53 |
|
|
|
|
|
|
|
|
|
|
|
Basic, pro forma |
|
$ |
0.24 |
|
|
$ |
0.48 |
|
|
$ |
0.43 |
|
|
|
|
|
|
|
|
|
|
|
Diluted, as reported |
|
$ |
0.60 |
|
|
$ |
0.68 |
|
|
$ |
0.50 |
|
|
|
|
|
|
|
|
|
|
|
Diluted, pro forma |
|
$ |
0.24 |
|
|
$ |
0.47 |
|
|
$ |
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
managements 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 Companys 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 Companys 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 Companys derivative
instruments are recorded on the balance sheet as either an asset or liability and measured at fair
value. The changes in the derivatives 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
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
are included in Other (income) expense, net in the Companys consolidated
statements of operations. These gains and losses substantially offset translation losses and gains
recorded on the Companys 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):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Interest |
|
$ |
657 |
|
|
$ |
717 |
|
|
$ |
994 |
|
Income taxes |
|
$ |
17,057 |
|
|
$ |
8,289 |
|
|
$ |
4,411 |
|
During 2004, the Company favorably resolved certain income tax contingencies associated with the
Companys 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 facilitys 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 Companys 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
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
Inventories |
|
$ |
1,312 |
|
Property, plant and equipment |
|
|
160 |
|
Acquired in-process research and development |
|
|
4,558 |
|
Intangible assets: |
|
|
|
|
Completed Technology |
|
|
1,575 |
|
Trademarks |
|
|
554 |
|
Other |
|
|
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 Companys 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):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Raw materials |
|
$ |
4,186 |
|
|
$ |
3,373 |
|
Work-in-process |
|
|
14,417 |
|
|
|
14,306 |
|
Finished goods |
|
|
63,778 |
|
|
|
58,590 |
|
|
|
|
|
|
|
|
|
|
$ |
82,381 |
|
|
$ |
76,269 |
|
|
|
|
|
|
|
|
5. Property, Plant and Equipment:
Property, plant and equipment consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Land and land improvements |
|
$ |
2,329 |
|
|
$ |
1,944 |
|
Buildings |
|
|
8,458 |
|
|
|
8,773 |
|
Machinery and equipment |
|
|
33,530 |
|
|
|
31,849 |
|
Furniture, fixtures and office equipment |
|
|
29,193 |
|
|
|
25,444 |
|
Construction in progress |
|
|
2,654 |
|
|
|
2,284 |
|
Surgical instruments |
|
|
72,088 |
|
|
|
56,963 |
|
|
|
|
|
|
|
|
|
|
|
148,252 |
|
|
|
127,257 |
|
Less: Accumulated depreciation |
|
|
(67,046 |
) |
|
|
(57,050 |
) |
|
|
|
|
|
|
|
|
|
$ |
81,206 |
|
|
$ |
70,207 |
|
|
|
|
|
|
|
|
57
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):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Land and land improvements |
|
$ |
235 |
|
|
$ |
269 |
|
Buildings |
|
|
3,018 |
|
|
|
3,247 |
|
Machinery and equipment |
|
|
6,346 |
|
|
|
8,103 |
|
Furniture, fixtures and office equipment |
|
|
2,309 |
|
|
|
2,135 |
|
|
|
|
|
|
|
|
|
|
|
11,908 |
|
|
|
13,754 |
|
Less: Accumulated depreciation |
|
|
(5,663 |
) |
|
|
(5,940 |
) |
|
|
|
|
|
|
|
|
|
$ |
6,245 |
|
|
$ |
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 |
|
$ |
8,845 |
|
Less: Foreign currency translation |
|
|
(1,016 |
) |
|
|
|
|
Goodwill, at December 31, 2005 |
|
$ |
7,829 |
|
|
|
|
|
The components of the Companys identifiable intangible assets are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 |
|
|
December 31, 2004 |
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Accumulated |
|
|
|
Cost |
|
|
Amortization |
|
|
Cost |
|
|
Amortization |
|
|
|
|
|
|
Distribution channels |
|
$ |
18,173 |
|
|
$ |
10,908 |
|
|
$ |
20,797 |
|
|
$ |
10,399 |
|
Completed technology |
|
|
5,243 |
|
|
|
2,353 |
|
|
|
5,348 |
|
|
|
1,733 |
|
Licenses |
|
|
2,756 |
|
|
|
1,847 |
|
|
|
2,683 |
|
|
|
1,538 |
|
Trademarks |
|
|
657 |
|
|
|
230 |
|
|
|
657 |
|
|
|
152 |
|
Other |
|
|
4,014 |
|
|
|
2,781 |
|
|
|
3,303 |
|
|
|
1,826 |
|
|
|
|
|
|
|
|
|
30,843 |
|
|
$ |
18,119 |
|
|
|
32,788 |
|
|
$ |
15,648 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: Accumulated
amortization |
|
|
(18,119 |
) |
|
|
|
|
|
|
(15,648 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
$ |
12,724 |
|
|
|
|
|
|
$ |
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
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):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Employee benefits |
|
$ |
10,873 |
|
|
$ |
11,476 |
|
Advances from factoring arrangement |
|
|
3,547 |
|
|
|
5,242 |
|
Royalties |
|
|
4,455 |
|
|
|
4,664 |
|
Taxes other than income |
|
|
5,604 |
|
|
|
4,120 |
|
Commissions |
|
|
3,982 |
|
|
|
3,818 |
|
Professional fees |
|
|
3,994 |
|
|
|
3,129 |
|
Purchased technology |
|
|
1,500 |
|
|
|
1,500 |
|
Legal |
|
|
1,429 |
|
|
|
1,153 |
|
Other |
|
|
9,671 |
|
|
|
9,817 |
|
|
|
|
|
|
|
|
|
|
$ |
45,055 |
|
|
$ |
44,919 |
|
|
|
|
|
|
|
|
8. Long-Term Obligations:
Long-term obligations consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Notes payable |
|
$ |
3,750 |
|
|
$ |
8,750 |
|
Capital lease obligations |
|
|
3,606 |
|
|
|
3,533 |
|
|
|
|
|
|
|
|
|
|
|
7,356 |
|
|
|
12,283 |
|
Less: current portion |
|
|
(5,628 |
) |
|
|
(6,331 |
) |
|
|
|
|
|
|
|
|
|
$ |
1,728 |
|
|
$ |
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 companys credit agreement.
Borrowings under the senior credit facility are guaranteed by all of the Companys subsidiaries and
collateralized by all of the assets of Wright Medical Technology, Inc., the Companys 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 Companys 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
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
of the net minimum lease payments, are as follows (in thousands):
|
|
|
|
|
2006 |
|
$ |
2,008 |
|
2007 |
|
|
1,179 |
|
2008 |
|
|
399 |
|
2009 |
|
|
172 |
|
2010 |
|
|
94 |
|
Thereafter |
|
|
6 |
|
|
|
|
|
Total minimum payments |
|
|
3,858 |
|
Less amount representing interest |
|
|
(252 |
) |
|
|
|
|
Present value of minimum lease payments |
|
|
3,606 |
|
Current portion |
|
|
(1,878 |
) |
|
|
|
|
Long-term portion |
|
$ |
1,728 |
|
|
|
|
|
9. Other Long-Term Liabilities:
Other long-term liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Accrued income taxes payable |
|
$ |
13,045 |
|
|
$ |
12,951 |
|
Other |
|
|
623 |
|
|
|
941 |
|
|
|
|
|
|
|
|
|
|
$ |
13,668 |
|
|
$ |
13,892 |
|
|
|
|
|
|
|
|
10. Capital Stock:
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 Companys
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 Companys income before income taxes are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Domestic |
|
$ |
43,588 |
|
|
$ |
40,437 |
|
|
$ |
25,675 |
|
Foreign |
|
|
(10,168 |
) |
|
|
(3,014 |
) |
|
|
1,444 |
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
$ |
33,420 |
|
|
$ |
37,423 |
|
|
$ |
27,119 |
|
|
|
|
|
|
|
|
|
|
|
60
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The components of the Companys provision for income taxes are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Current provision: |
|
|
|
|
|
|
|
|
|
|
|
|
Domestic: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
9,777 |
|
|
$ |
12,815 |
|
|
$ |
3,080 |
|
State |
|
|
1,709 |
|
|
|
811 |
|
|
|
203 |
|
Foreign |
|
|
1,385 |
|
|
|
4,401 |
|
|
|
1,404 |
|
Deferred provision (benefit): |
|
|
|
|
|
|
|
|
|
|
|
|
Domestic: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
3,013 |
|
|
|
(197 |
) |
|
|
4,313 |
|
State |
|
|
605 |
|
|
|
803 |
|
|
|
1,098 |
|
Foreign |
|
|
(4,134 |
) |
|
|
(5,232 |
) |
|
|
(376 |
) |
|
|
|
|
|
|
|
|
|
|
Total provision for income taxes |
|
$ |
12,355 |
|
|
$ |
13,401 |
|
|
$ |
9,722 |
|
|
|
|
|
|
|
|
|
|
|
A reconciliation of the statutory federal income tax rate to the Companys effective income tax
rate is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2005 |
|
2004 |
|
2003 |
Income tax provision at statutory rate |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
State tax provision |
|
|
5.3 |
% |
|
|
4.8 |
% |
|
|
4.4 |
% |
Change in valuation allowance |
|
|
(1.2 |
%) |
|
|
(3.1 |
%) |
|
|
4.5 |
% |
Meals and entertainment limitation |
|
|
1.5 |
% |
|
|
1.0 |
% |
|
|
1.2 |
% |
Research and development credit |
|
|
(2.3 |
%) |
|
|
(2.6 |
%) |
|
|
(9.9 |
%) |
Tax exempt interest |
|
|
(1.2 |
%) |
|
|
|
|
|
|
|
|
Other, net |
|
|
(0.1 |
%) |
|
|
0.7 |
% |
|
|
0.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
37.0 |
% |
|
|
35.8 |
% |
|
|
35.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
The significant components of the Companys deferred tax assets and liabilities as of December 31,
2005 and 2004 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Operating loss carryforwards |
|
$ |
13,924 |
|
|
$ |
13,755 |
|
General business credit carryforward |
|
|
2,341 |
|
|
|
2,309 |
|
Alternative minimum tax credits |
|
|
|
|
|
|
621 |
|
Reserves and allowances |
|
|
18,031 |
|
|
|
19,399 |
|
Amortization |
|
|
5,230 |
|
|
|
5,660 |
|
Other |
|
|
11,856 |
|
|
|
11,718 |
|
Valuation allowance |
|
|
(5,964 |
) |
|
|
(6,820 |
) |
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
45,418 |
|
|
|
46,642 |
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
6,205 |
|
|
|
4,523 |
|
Acquired intangible assets |
|
|
2,661 |
|
|
|
3,767 |
|
Other |
|
|
4,297 |
|
|
|
5,570 |
|
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
|
13,163 |
|
|
|
13,860 |
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
32,255 |
|
|
$ |
32,782 |
|
|
|
|
|
|
|
|
61
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 Companys 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 Companys 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):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2005 |
|
2004 |
|
2003 |
Weighted-average number of common
shares outstanding basic |
|
|
33,959 |
|
|
|
33,391 |
|
|
|
32,857 |
|
Common stock equivalents |
|
|
1,240 |
|
|
|
1,926 |
|
|
|
1,704 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common
shares outstanding diluted |
|
|
35,199 |
|
|
|
35,317 |
|
|
|
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 Companys 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
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 Companys 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 Companys 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2005 |
|
2004 |
|
2003 |
Risk-free interest rate |
|
|
4.0% - 4.5 |
% |
|
|
4.0% - 4.8 |
% |
|
|
3.6% - 4.3 |
% |
Expected option life |
|
7 years |
|
7 years |
|
7 years |
Expected price volatility |
|
|
39.8 |
% |
|
|
50.1 |
% |
|
|
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 Companys stock option activity is as follows (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
|
|
|
|
|
Weighted Avg. |
|
|
|
Shares |
|
|
Exercise Price |
|
Outstanding at December 31, 2002 |
|
|
3,288 |
|
|
$ |
7.58 |
|
Granted |
|
|
1,333 |
|
|
|
21.80 |
|
Exercised |
|
|
(309 |
) |
|
|
4.67 |
|
Forfeited or expired |
|
|
(78 |
) |
|
|
7.25 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2003 |
|
|
4,234 |
|
|
$ |
12.28 |
|
Granted |
|
|
2,458 |
|
|
|
30.61 |
|
Exercised |
|
|
(505 |
) |
|
|
7.53 |
|
Forfeited or expired |
|
|
(359 |
) |
|
|
24.34 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2004 |
|
|
5,828 |
|
|
$ |
19.68 |
|
Granted |
|
|
1,819 |
|
|
|
23.82 |
|
Exercised |
|
|
(314 |
) |
|
|
8.61 |
|
Forfeited or expired |
|
|
(1,145 |
) |
|
|
30.01 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2005 |
|
|
6,188 |
|
|
$ |
19.55 |
|
|
|
|
|
|
|
|
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 Companys 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
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 Companys stock options outstanding and exercisable at December 31, 2005, is as
follows (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Options Exercisable |
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Weighted-Average |
|
|
Average |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Remaining |
|
|
Exercise |
|
|
Number |
|
|
Exercise |
|
Range of Exercise Prices |
|
Number Outstanding |
|
|
Contractual Life |
|
|
Price |
|
|
Exercisable |
|
|
Price |
|
$ 0.00 $8.50 |
|
|
1,600 |
|
|
|
4.5 |
|
|
$ |
4.97 |
|
|
|
1,600 |
|
|
$ |
4.97 |
|
$ 8.51 $16.00 |
|
|
79 |
|
|
|
6.7 |
|
|
|
15.16 |
|
|
|
53 |
|
|
|
15.16 |
|
$16.01 $24.00 |
|
|
1,832 |
|
|
|
7.6 |
|
|
|
20.18 |
|
|
|
655 |
|
|
|
19.05 |
|
$24.01 $32.00 |
|
|
2,541 |
|
|
|
8.5 |
|
|
|
27.63 |
|
|
|
574 |
|
|
|
28.20 |
|
$32.01 $35.87 |
|
|
136 |
|
|
|
8.4 |
|
|
|
33.96 |
|
|
|
36 |
|
|
|
34.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,188 |
|
|
|
7.2 |
|
|
$ |
19.55 |
|
|
|
2,918 |
|
|
$ |
13.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Stock Purchase Plan
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 Companys 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2005 |
|
2004 |
|
2003 |
Risk-free interest rate |
|
|
3.0% - 3.6 |
% |
|
|
1.9% - 2.8 |
% |
|
|
1.1% - 1.8 |
% |
Expected option life |
|
6 months |
|
6 months |
|
6 months |
Expected price volatility |
|
|
39.8 |
% |
|
|
50.1 |
% |
|
|
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 employees annual
compensation and at a rate of 50% for the next 2% of an employees annual compensation. Employees
vest in the Companys contributions after three years of service with the Company. The Companys
expense related to the plan was approximately $940,000, $830,000, and $720,000 in 2005, 2004, and
2003, respectively.
64
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 |
|
$ |
6,167 |
|
2007 |
|
|
4,515 |
|
2008 |
|
|
1,977 |
|
2009 |
|
|
553 |
|
2010 |
|
|
433 |
|
Thereafter |
|
|
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 |
|
$ |
3,369 |
|
2007 |
|
|
431 |
|
2008 |
|
|
430 |
|
2009 |
|
|
430 |
|
2010 |
|
|
330 |
|
Thereafter |
|
|
1,327 |
|
|
|
|
|
|
|
$ |
6,317 |
|
|
|
|
|
Portions of the Companys 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 Companys 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
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 courts judgment to the United States Court of Appeals for the Seventh Circuit.
In June 2005, the appeals court upheld the trial courts ruling granting CERAbio summary judgment
on certain of the Companys counterclaims, but overruled the trial courts ruling limiting the
Companys 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 Companys knee product line. The
Company believes, however, that it has strong defenses against Howmedicas claims and thus is
vigorously defending this lawsuit. In November 2005, the court issued a Markman ruling on claim
construction holding that the Companys products do not literally infringe the claims of
Howmedicas 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 Companys 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 Companys 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 Companys loss estimate includes an assumption for
unasserted claims based on managements 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 Companys 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 Companys 1993 agreement with DCC
pursuant to which the Predecessor Company purchased certain small joint orthopaedic
66
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 Companys 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 Companys
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):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Net sales by product line: |
|
|
|
|
|
|
|
|
|
|
|
|
Hips products |
|
$ |
109,267 |
|
|
$ |
99,133 |
|
|
$ |
78,071 |
|
Knee products |
|
|
94,073 |
|
|
|
87,408 |
|
|
|
78,338 |
|
Biologics products |
|
|
62,358 |
|
|
|
62,070 |
|
|
|
50,056 |
|
Extremity products |
|
|
40,594 |
|
|
|
36,433 |
|
|
|
31,876 |
|
Other |
|
|
12,845 |
|
|
|
12,495 |
|
|
|
10,591 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
319,137 |
|
|
$ |
297,539 |
|
|
$ |
248,932 |
|
|
|
|
|
|
|
|
|
|
|
67
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Net sales by geographic region: |
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
197,548 |
|
|
$ |
180,380 |
|
|
$ |
152,864 |
|
Europe |
|
|
80,374 |
|
|
|
84,726 |
|
|
|
70,078 |
|
Other |
|
|
41,215 |
|
|
|
32,433 |
|
|
|
25,990 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
319,137 |
|
|
$ |
297,539 |
|
|
$ |
248,932 |
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) by
geographic region: |
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
32,464 |
|
|
$ |
31,209 |
|
|
$ |
18,772 |
|
Europe |
|
|
(5,633 |
) |
|
|
3,535 |
|
|
|
7,110 |
|
Other |
|
|
6,650 |
|
|
|
3,669 |
|
|
|
1,284 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
33,481 |
|
|
$ |
38,413 |
|
|
$ |
27,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Long-lived assets: |
|
|
|
|
|
|
|
|
United States |
|
$ |
58,237 |
|
|
$ |
45,905 |
|
Europe |
|
|
18,012 |
|
|
|
20,356 |
|
Other |
|
|
4,957 |
|
|
|
3,946 |
|
|
|
|
|
|
|
|
Total |
|
$ |
81,206 |
|
|
$ |
70,207 |
|
|
|
|
|
|
|
|
No single foreign country accounted for more than 10% of the Companys total net sales during 2005,
2004 or 2003; however, Italy and France together represented approximately 12% of the Companys
total net sales in 2005, and 16% of the Companys total net sales in both 2004 and 2003.
During the year ended December 31, 2005, the Companys 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 Companys 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
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
|
First |
|
|
Second |
|
|
Third |
|
|
Fourth |
|
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
Net sales |
|
$ |
82,601 |
|
|
$ |
82,789 |
|
|
$ |
73,479 |
|
|
$ |
80,268 |
|
Cost of sales |
|
|
22,777 |
|
|
|
24,358 |
|
|
|
20,263 |
|
|
|
24,342 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
59,824 |
|
|
|
58,431 |
|
|
|
53,216 |
|
|
|
55,926 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
41,668 |
|
|
|
39,183 |
|
|
|
40,045 |
|
|
|
46,020 |
|
Research and development |
|
|
4,897 |
|
|
|
5,699 |
|
|
|
5,904 |
|
|
|
5,783 |
|
Amortization of intangible assets |
|
|
1,059 |
|
|
|
1,040 |
|
|
|
1,020 |
|
|
|
1,131 |
|
Stock-based expense |
|
|
212 |
|
|
|
119 |
|
|
|
65 |
|
|
|
71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
47,836 |
|
|
|
46,041 |
|
|
|
47,034 |
|
|
|
53,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
$ |
11,988 |
|
|
$ |
12,390 |
|
|
$ |
6,182 |
|
|
$ |
2,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
7,269 |
|
|
$ |
7,767 |
|
|
$ |
3,986 |
|
|
$ |
2,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share, basic |
|
$ |
0.21 |
|
|
$ |
0.23 |
|
|
$ |
0.12 |
|
|
$ |
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share, diluted |
|
$ |
0.21 |
|
|
$ |
0.22 |
|
|
$ |
0.11 |
|
|
$ |
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 |
|
|
|
First |
|
|
Second |
|
|
Third |
|
|
Fourth |
|
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
Net sales |
|
$ |
74,917 |
|
|
$ |
75,616 |
|
|
$ |
69,299 |
|
|
$ |
77,707 |
|
Cost of sales |
|
|
20,386 |
|
|
|
21,383 |
|
|
|
19,998 |
|
|
|
22,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
54,531 |
|
|
|
54,233 |
|
|
|
49,301 |
|
|
|
55,291 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
37,134 |
|
|
|
37,714 |
|
|
|
36,611 |
|
|
|
39,685 |
|
Research and development |
|
|
4,982 |
|
|
|
4,524 |
|
|
|
4,302 |
|
|
|
4,613 |
|
Amortization of intangible assets |
|
|
942 |
|
|
|
928 |
|
|
|
975 |
|
|
|
1,044 |
|
Stock-based expense |
|
|
424 |
|
|
|
465 |
|
|
|
271 |
|
|
|
329 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
43,482 |
|
|
|
43,631 |
|
|
|
42,159 |
|
|
|
45,671 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
$ |
11,049 |
|
|
$ |
10,602 |
|
|
$ |
7,142 |
|
|
$ |
9,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
6,614 |
|
|
$ |
6,688 |
|
|
$ |
4,430 |
|
|
$ |
6,290 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share, basic |
|
$ |
0.20 |
|
|
$ |
0.20 |
|
|
$ |
0.13 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share, diluted |
|
$ |
0.19 |
|
|
$ |
0.19 |
|
|
$ |
0.13 |
|
|
$ |
0.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys 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 Companys 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 Companys 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 Companys net income for the fourth quarter of 2004
included the after-tax effect of approximately $2.9 million of charges associated with the
Companys foot and ankle product line transition.
69
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 SECs rules and forms.
Managements 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 managements 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
PART III
Item 10. Directors and Executive Officers of the Registrant.
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
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
|
|
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) |
|
|
|
2.2
|
|
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) |
|
|
|
3.1
|
|
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) |
|
|
|
3.2
|
|
Amended and Restated By-laws of Wright Medical Group, Inc. (4) |
|
|
|
4.1
|
|
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) |
|
|
|
4.2
|
|
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) |
|
|
|
4.3
|
|
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
|
|
|
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
|
|
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) |
|
|
|
10.10
|
|
Employment Agreement dated as of April 25, 2005, between Wright Medical Technology, Inc. and
R. Glen Coleman. (11) |
|
|
|
10.11
|
|
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc.
and F. Barry Bays. (14) |
|
|
|
10.12
|
|
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc.
and Jeffrey G. Roberts. (14) |
|
|
|
10.13
|
|
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc.
and John K. Bakewell. (14) |
|
|
|
10.14
|
|
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc.
and John R. Treace.(14) |
|
|
|
10.15
|
|
Severance and Release Agreement dated as of April 1, 2005, between Wright Medical Technology,
Inc. and Brian T. Ennis. (11) |
|
|
|
10.16
|
|
Severance and Release Agreement dated as of October 5, 2005, between Wright Medical
Technology, Inc. and Laurence Y. Fairey. (15) |
|
|
|
10.17
|
|
Severance and Release Agreement dated as of October 17, 2005, between Wright Medical
Technology, Inc. and R. Glen Coleman. (16) |
|
|
|
11
|
|
Computation of earnings per share (included in Note 12 of the Notes to Consolidated Financial
Statements (unaudited) in Item 8 of this report). |
|
|
|
21
|
|
Subsidiaries of Wright Medical Group, Inc. |
|
|
|
23
|
|
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
|
|
|
(1) |
|
Incorporated by reference to the Companys Registration Statement on Form S-1 (Registration
No. 333-59732), as amended. |
|
(2) |
|
Incorporated by reference to the Companys annual report on Form 10-K for the year ended
December 31, 2002. |
|
(3) |
|
Incorporated by reference to the Companys Registration Statement on Form S-8 filed on May
14, 2004. |
|
(4) |
|
Incorporated by reference to the Companys current report on Form 8-K filed on March 31,
2004. |
|
(5) |
|
Incorporated by reference to the Companys current report on Form 8-K filed on August 3,
2001. |
|
(6) |
|
Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter
ended June 30, 2003. |
|
(7) |
|
Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter
ended September 30, 2003. |
|
(8) |
|
Incorporated by reference to the Companys current report on Form 8-K filed on December 7,
2004. |
|
(9) |
|
Incorporated by reference to the Companys current report on Form 8-K filed on April 7,
2005. |
|
(10) |
|
Incorporated by reference to the Companys definitive Proxy Statement on April 13, 2005. |
|
(11) |
|
Incorporated by reference to the Companys current report on Form 8-K filed on April 27,
2005. |
|
(12) |
|
Incorporated by reference to the Companys current report on Form 8-K filed on February 10,
2005. |
|
(13) |
|
Incorporated by reference to the Companys quarterly report on Form 10-Q for the quarter
ended June 30, 2004. |
|
(14) |
|
Incorporated by reference to the Companys current report on Form 8-K filed on November 22,
2005. |
|
(15) |
|
Incorporated by reference to the Companys current report on Form 8-K filed on October 6,
2005. |
|
(16) |
|
Incorporated by reference to the Companys current report on Form 8-K filed on October 20,
2005. |
74
SIGNATURES
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.
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 |
|
Title |
|
Date |
|
|
|
|
|
/s/ F. Barry Bays
|
|
President, Chief Executive Officer and Director
|
|
February 28, 2006 |
|
|
|
|
|
F. Barry Bays
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
/s/ John K. Bakewell
|
|
Chief Financial Officer (Principal Financial
|
|
February 28, 2006 |
|
|
|
|
|
John K. Bakewell
|
|
Officer and Principal Accounting Officer) |
|
|
|
|
|
|
|
/s/ James T. Treace
|
|
Executive Chairman of the Board
|
|
February 28, 2006 |
|
|
|
|
|
James T. Treace |
|
|
|
|
|
|
|
|
|
/s/ Richard B. Emmitt
|
|
Director
|
|
February 28, 2006 |
|
|
|
|
|
Richard B. Emmitt |
|
|
|
|
|
|
|
|
|
/s/ David D. Stevens
|
|
Director
|
|
February 28, 2006 |
|
|
|
|
|
David D. Stevens |
|
|
|
|
|
|
|
|
|
/s/ James E. Thomas
James E. Thomas
|
|
Director
|
|
February 28, 2006 |
|
|
|
|
|
/s/ Thomas E. Timbie
|
|
Director
|
|
February 28, 2006 |
|
|
|
|
|
Thomas E. Timbie |
|
|
|
|
|
|
|
|
|
/s/ Elizabeth H. Weatherman
|
|
Director
|
|
February 28, 2006 |
|
|
|
|
|
Elizabeth H. Weatherman |
|
|
|
|
75
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Wright Medical Group, Inc.:
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
Companys 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
Wright Medical Group, Inc.
Schedule II-Valuation and Qualifying Accounts
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Charged to |
|
|
|
|
|
|
Balance at |
|
|
|
Beginning |
|
|
Cost and |
|
|
Deductions |
|
|
End of |
|
|
|
of Period |
|
|
Expenses |
|
|
and Other |
|
|
Period |
|
Allowance for doubtful accounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 |
|
$ |
1,820 |
|
|
$ |
510 |
|
|
$ |
(333 |
) |
|
$ |
1,997 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004 |
|
$ |
1,489 |
|
|
$ |
268 |
|
|
$ |
(63 |
) |
|
$ |
1,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2003 |
|
$ |
1,509 |
|
|
$ |
87 |
|
|
$ |
107 |
|
|
$ |
1,489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales returns and allowance: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 |
|
$ |
395 |
|
|
$ |
39 |
|
|
$ |
|
|
|
$ |
434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004 |
|
$ |
412 |
|
|
$ |
(17 |
) |
|
$ |
|
|
|
$ |
395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2003 |
|
$ |
987 |
|
|
$ |
(101 |
) |
|
$ |
474 |
|
|
$ |
412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
S-2