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, 2008
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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:
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Title of each class |
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Name of each exchange on which registered |
Common Stock, par value $0.01
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NASDAQ Global Select Market |
per share |
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Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of
the Securities Act.
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Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or
Section 15(d) of the Act.
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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,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Non-accelerated filer o
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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 $1,066,251,619.
As of
February 17, 2009, there were 38,003,980 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, 2008, pursuant to Regulation 14A
under the Securities Exchange Act of 1934 in connection with the annual meeting of stockholders to
be held on May 13, 2009.
WRIGHT MEDICAL GROUP, INC.
ANNUAL REPORT ON FORM 10-K
Table of Contents
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. Forward-looking statements reflect managements current knowledge, assumptions, beliefs,
estimates, and expectations and express managements current views of future performance, results,
and trends and may be identified by their use of terms such as anticipate, believe, could,
estimate, expect, intend, may, plan, predict, project, will, and other similar
terms. Forward-looking statements are contained in the section entitled Managements Discussion
and Analysis of Financial Condition and Results of Operations and other sections of this annual
report. 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 report and in our other quarterly
reports), which could cause our actual results to materially differ 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. Readers should not 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 (Wright), 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 or have been
damaged 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, 2008, we had net sales of $465.5 million and net income of $3.2
million. As of December 31, 2008, we had total assets of $692 million. Detailed information on our
net sales by product line and our net sales, operating income and long-lived assets by geographic
region can be found in Note 18 to the consolidated financial statements contained in Financial
Statements and Supplementary Data.
Orthopaedic Industry
Seven multinational companies currently dominate the orthopaedic industry. 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 are opportunities for mid-sized orthopaedic companies, such as Wright, to focus on
smaller, higher-growth sectors of the orthopaedic market. We believe that we can strategically meet
these opportunities while simultaneously offering a comprehensive product line to address the
day-to-day needs of our 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. Our product
offerings include large joint implants for the hip and knee; extremity implants for the hand,
elbow, shoulder, foot and ankle; and both synthetic- and tissue-based bone graft substitute
materials.
Reconstructive Joint Device Market
Most reconstructive joint devices are used to replace or repair joints that have deteriorated or
have been damaged as a result of disease or injury. Despite the availability of non-surgical
treatment alternatives such as oral medications, injections and joint fluid supplementation, 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, with knee reconstruction and hip reconstruction representing 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.
One
of the major trends in knee reconstruction includes the use of alternative surface materials to
extend the implant life and increase conservation of the patients bone to minimize surgical
trauma and accelerate recovery. Our BIOFOAM material is a 70% porous material which
provides a trabecular structure that acts as an interface for bone in-growth. The microstructure of
our BIOFOAM material is designed to allow rigid fixation for faster biological
attachment. This material made its debut on the ADVANCE® BIOFOAM cancellous
titanium tibial base, and will eventually be incorporated into a number of our products spanning
from hip arthroplasty to foot and
ankle reconstruction.
1
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.
Similar to the knee reconstruction market, major trends in hip replacement procedures and implants
are to extend implant life and to preserve bone for possible future procedures. New products have
been developed that incorporate advances in bearing surfaces from the traditional polyethylene
surface. These alternative bearing surfaces include metal-on-metal, cross-linked polyethylene and
ceramic-on-ceramic combinations, which exhibit improved wear characteristics and lead to longer
implant life. One example of Wrights commitment to the advancement of bearing technology is the
development of our A-CLASS® metal-on-metal articulation. This proprietary metal-on-metal
articulation has undergone extensive laboratory tests which suggest that over the life of the
implant, this advanced surface technology will result in significantly less wear than traditional
metal-on-metal hip implants. In addition to advances in bearing surfaces, implants and surgical
techniques that preserve more natural bone have been developed to minimize surgical trauma and
accelerate recovery time for patients. These implants, known as bone-conserving implants, leave
more of the hip bones intact, which is beneficial given the increasing likelihood of future
reconstruction 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 total hip implant is required.
Extremity
Reconstruction. Extremity reconstruction involves implanting devices to replace or
reconstruct injured or diseased joints such as the wrist, elbow, ankle and
shoulder and those in the finger, toe and foot. Major trends in extremity reconstruction include unique distal radius (wrist) and foot
and ankle fixation and arthroplasty devices.
Upper
Extremity Reconstruction. Upper extremity reconstruction involves implanting devices to
replace or reconstruct injured or diseased joints such as the wrist, elbow, and
shoulder and those in the finger.
Foot and Ankle Reconstruction. Foot and ankle extremity reconstruction involves implanting devices
to replace or reconstruct injured or diseased joints in the foot and ankle. A large segment of the
foot and ankle market is comprised of plating and screw systems for reconstructing and fusing
joints or repairing bones post traumatic injury. Other major trends include the use of external
fixation devices in diabetic patients and total ankle arthroplasty.
Biologics Market. Biologics products use both biological tissue-based and synthetic materials to
regenerate damaged or diseased bone as well as to repair damaged or diseased soft tissue. These
products stimulate the bodys natural regenerative capabilities to heal itself, minimizing or
delaying the need for invasive implant surgery.
Wrights biologics products are primarily used in trauma or tumor induced voids of the long bones,
joint replacements and in the wrist and foot. Biologic products provide a lower morbidity
alternative 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: osteoconductive,
osteoinductive and osteogenic. Each category refers to the way in which the materials affect bone
growth. Osteoconductive materials serve as a scaffold that supports the formation of bone but do
not trigger new bone growth, whereas osteoinductive materials serve as scaffold to support
formation of bone and induce bone growth. Finally, osteogenic materials combine the latter with a
cell-based component. Wrights flagship, PRO-DENSE® Injectable Regenerative Graft is an
osteoconductive bone graft which provides the benefits of injectability, hardness to support bone
and predictable bone regeneration. Products such as our GRAFTJACKET® Regenerative
Tissue Matrix, enable the repair of soft tissue such as the rotator cuff and the Achilles tendons,
ligaments, or chronic wounds (such as diabetic foot ulcers). With over 7% of the U.S. population
affected by diabetes, the need for biomaterials that speed wound healing and reduce amputation
rates is critical.
Government Regulation
United States
Our products are strictly regulated by the United States Food and Drug Administration (FDA) under
the Food, Drug,
2
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), and various state agency regulations. We are an
accredited member of the American Association of Tissue Banks (AATB).
Generally, before we can market a new medical device, marketing clearance from the FDA must be
obtained through either a premarket notification under Section 510(k) of the FDC Act or the
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
usually takes about 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, 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 and the device presents a significant
risk, the sponsor of the trial 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. 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.
In particular, the FDA has statutory authority to regulate allograft-based products, processing and
materials. The FDA and other international regulatory agencies have been working to establish more
comprehensive regulatory frameworks for allograft-based tissue-containing products, which are
principally derived from human cadaveric tissue. The framework developed by the FDA establishes
risk-based criteria for determining whether a particular human tissue-based product will be
classified as human tissue, a medical device or a biologic drug requiring premarket clearance or
approval. All tissue-based products are subject to extensive FDA regulation, including
establishment registration requirements, product listing requirements, good tissue practice
requirements for manufacturing and screening requirements that ensure that diseases are not
transmitted to tissue recipients. The FDA has also proposed extensive additional requirements that
address sub-contracted tissue services, tracking to the recipient/patient, and donor records
review. If a tissue-based product is considered human tissue, the FDA requirements focus on
preventing the introduction, transmission and spread of communicable diseases to recipients.
Neither clinical data nor review of safety and efficacy are required before the tissue can be
marketed. However, if it is considered a medical device, or a biologic drug, then FDA clearance or
approval is 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 our
operations. 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
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and drug manufacturing facilities in the U.S. in order to assure compliance with applicable
quality system regulations.
Most of our products are FDA cleared through the 510(k) premarket notification process. We have
conducted clinical trials to support some 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. If
the FDA believes that we are not in compliance with the FDC Act, 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.
Further, 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 healthcare reimbursement programs. 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.
International
All of our products sold internationally are subject to certain foreign regulatory approvals. We
must 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.
In order to market our product devices in the member countries of the European Union (EU), we are
required to comply with the European Medical Device 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 Device Directives. Under the European Medical Device
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 Ministry of Health Labor and
Welfare (MHLW) approval in Japan, Health Protection Branch (HPB) approval in Canada and Therapeutic
Goods Administration (TGA) approval in Australia.
Products
We operate as one reportable segment, offering products in four primary market sectors: knee
reconstruction, hip reconstruction, extremity reconstruction and biologics. Sales in each of these
markets represent greater than 15% of our consolidated revenue. Detailed information on our net
sales by product line can be found in Note 18 to the consolidated financial statements contained in
Financial Statements and Supplementary Data.
Knee Reconstruction
Our knee reconstruction product portfolio strategically positions us in the areas of partial, total
and revision knee reconstruction in addition to 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 natural movement and stability,
resulting in products that more closely resemble a healthy knee.
The ADVANCE® knee system is our primary knee product line. There are several innovative
product offerings within the ADVANCE® knee system, but our flagship is the
ADVANCE® Medial-Pivot Knee. Launched eleven
years ago, the ADVANCE® Medial-Pivot Knee is the first mass marketed knee designed to
replicate modern concepts of anatomic motion. It approximates the movement and stability of a
healthy knee by incorporating a patented ball-in-socket feature on its medial side which allows
both surgeons and patients to feel the stability. Studies have shown the ADVANCE®
Medial-Pivot Knee more closely approximates natural knee motion and is preferred by patients.
4
Our ADVANCE® Double-High Knee is designed to address the needs of surgeons who desire
high flexion and high stability while retaining the posterior cruciate ligament (PCL) and
maintaining medial-pivoting kinematics. The knee addresses an adverse phenomenon, known as
paradoxical motion that often occurs with other PCL-retaining knee systems. Most knee implants
using PCL retention are based on the theory that the ligament will provide stability and increased
flexion. Due to the phenomenon of paradoxical motion, small amounts of uncontrolled sliding can
occur within the artificial knee. This movement prevents the knee from functioning in an
anatomically stable, consistent manner and can result in abnormal gait and reduced flexion. The
ADVANCE® Double-High Knee, like the ADVANCE® Medial-Pivot Knee, is designed
to prevent paradoxical motion through medial-pivoting articulation; thereby providing stability and
maximizing PCL function.
To offer better size-specificity for our patients, the ADVANCE® knee system features an
expanded number of sizing options called ADVANCE STATURE® components. These components
are designed to accommodate those male or female femora with a larger front to back dimension than
side to side. This helps ensure that patients will receive the best implant fit possible.
Additionally, we provide a broad array of surgical instrumentation
to accommodate surgeon and
patient preference. Our ODYSSEY® instrumentation
is a modification of traditional total
knee instrumentation for use in contemporary
less-invasive approaches. These less invasive approaches, sometimes referred to as minimally
invasive surgery (MIS), have gained popularity due to the smaller incision and minimal disruption
of soft tissues, which can significantly reduce recovery times. Unfortunately, not all patients are
candidates for less invasive approaches. Our surgical instrumentation has been designed for
precision in any incision; offering equal effectiveness and accuracy in both open and less invasive
approaches.
During 2009, we anticipate increased utilization of our ADVANCE® BIOFOAM
cancellous titanium tibial base. Our BIOFOAM Tibial Base features a proprietary
bone-like titanium with a roughened texture that bites into bone for cementless fixation of the
implant. Cement-free fixation is a growing trend in knee reconstruction due to the influx of
younger patients with active lifestyles and increased body weight. These patients require
longer-lasting implants, and cement-free designs may have longer survivorship than cemented
designs. One of the most important requirements to achieving solid bone in-growth in a cement-free
knee is immediate, rigid fixation of the implant to the bone. This is afforded through the rough
surface of BIOFOAM titanium.
Our breakthrough REPIPHYSIS® technology is implanted in children and expands as they
grow. 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 technology is in the field of pediatric oncology, where growing children can
have their limbs lengthened without the need for additional surgeries.
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. Therefore, we are able to offer surgeons and their patients a full continuum
of treatment options.
The CONSERVE® family of products incorporates anatomically-replicating large diameter
bearings, led recently by the A-CLASS® advanced metal technology. This new, proprietary
metal-on-metal articulation has undergone extensive laboratory tests which suggest that over the
life of the implant, this advanced surface technology will result in significantly less wear than
traditional metal-on-metal hip implants. This new innovation is coupled with
our BFH® technology, which is designed to reduce rates of post-operative hip
dislocation.
We continue to invest in pioneering approaches to tissue sparing hip replacement. The
PATH® surgical technique offers patients quicker recovery due to a decrease of
intraoperative soft tissue trauma. The decreased soft tissue trauma results in less pain and blood
loss for the patient, as well as a lower risk of dislocation.
5
The PROFEMUR® patented modular neck systems allow surgeons to carefully adjust and
implant positioning during surgery. If a surgeon requires a change in leg length, offset or
version, the PROFEMUR® hip system conveniently allows these options, as all of these
options can be changed after the hip stem is in place. Our principal PROFEMUR® stem
offerings which provide this innovative modularity include our PROFEMUR® Z,
PROFEMUR® Plasma Z, PROFEMUR® LX, PROFEMUR® Tapered,
PROFEMUR® RAZ, PROFEMUR® TL, PROFEMUR® Xm, and the
PROFEMUR® RENAISSANCE® stems. These stems represent the vast majority of
popular stem philosophies in the current marketplace.
Additionally, hip revision products continue to be a focus for us. The PROFEMUR® Z
Revision and PROFEMUR® LX Revision stems were launched in 2008 and continue to gain
traction. A North American distribution agreement with Waldemar Link GmbH for the distribution of
the LINK® MP revision stem has also proven to be an important addition to our hip
product portfolio.
The DYNASTY® acetabular system offers surgeons the benefit of our BFH®
technology both in metal-on-metal and metal-on-cross-linked poly options with the added benefit of
screw fixation. Screw fixation is sometimes needed in the case of poor bone quality.
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 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 foot and ankle and upper extremity in a number of markets
worldwide. Some of our extremity implants have over 40 years of successful clinical history. Wright
is a recognized leader in the U.S. and German markets for foot and ankle surgical products.
Additionally, we hold leading positions in several segments of the upper extremity market such as
radial head repair, finger joint replacements and intramedullary wrist fracture implants.
Our CHARLOTTE foot and ankle system is an extensive offering of fixation products for
foot and ankle surgery, and includes products that feature advanced design elements for simplicity,
versatility and high performance. Adding to the CHARLOTTE portfolio, in 2006, we
introduced the first ever locking compressing plate designed for corrective foot surgeries. The
CLAW® plate allows
surgeons to modify the length of screws used and amount of compression to
the fusion site, a strong advantage over traditional staples.
The DARCO® foot and ankle plating systems were designed to address the specific needs of
reconstructive foot and ankle surgery. The DARCO® MFS and MRS plates were the first
implants to incorporate fixed angle, locking screw technology into a comprehensive fixation set for
foot surgery. Surgeons believe that with locking screw technology, surgical repairs are more
stable, thus allowing for patients to return to activity faster.
Our SIDEKICK line of external fixators are designed to facilitate compression or
distraction of bones in the foot from the outside in and in a minimally invasive manner.
In April 2008, we acquired Inbone Technologies, Inc., a manufacturer and marketer of the
INBONE Total Ankle Replacement System and Intra-Osseous Fusion Rods. The
INBONE Total Ankle System represents the third generation in ankle replacement implants, utilizing a patented
intramedullary alignment
mechanism for more accurate placement of the implant. The unique modular nature of the implant
allows the surgeon to customize the fixation stems for the tibial and talar components in order to
maximize stability of the implant. Accuracy of placement and implant stability have been shown to
be key factors impacting longevity of the implant. The INBONE system represents key
advances in these critical arenas.
6
Our line of Swanson finger joints are used in finger joint replacement for patients suffering from
rheumatoid arthritis of the hand. With nearly forty years of clinical success, Swanson digit
implants are a foundation in our upper extremity business and are used by a loyal base of hand
surgeons worldwide.
Our EVOLVE® modular radial head replacement prosthesis addresses the need for modularity
in the anatomically highly-variable joint of the elbow 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 and bone interface and for radiocapitellar articulation, potentially reducing capitellar
wear. Our EVOLVE® radial head plating system is for surgeons who wish to repair rather
than replace the damaged radial head. With prostheses and plating, we believe we have become the
vendor of choice for repair of radial head fractures. Further strengthening our position in the
radial head market, in 2007, we introduced our EVOLVE® Proline system, which adds
additional size offerings and in-situ locking of the implant, a favorable feature for surgeons
treating patients with intact elbow ligaments.
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. Also, as the product is implanted within the bone, it has no external profile on top of
the bone, thereby removing the potential for tendon irritation or rupture, which is an appreciable
problem with conventional plates which are designed to lie on top of the bone.
Biologics
We offer a broad line of biologics products that are used to replace and repair damaged or diseased
bone, tendons and 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.
GRAFTJACKET® is a human-derived soft tissue graft designed for augmentation of tendon
and ligament repairs such as those of the rotator cuff in the shoulder and Achilles tendon in the
ankle. By augmenting the strength of the tendon repair and incorporating biologically,
GRAFTJACKET® regenerative tissue matrix increases surgeons confidence in the surgical
outcome. GRAFTJACKET® Maxforce Extreme is a high strength form of GRAFTJACKET®
matrix which provides maximum suture holding power for the most challenging of tendon and
ligament repairs.
GRAFTJACKET® ulcer repair matrix 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® ulcer
repair matrix has the ability to reliably repair deep foot wounds, which have a much higher risk of
leading to amputation. Unlike some other diabetic foot ulcer products, GRAFTJACKET®
ulcer repair matrix generally requires only one application to treat the foot ulcer, thereby
reducing the time and cost of treatment.
Our BIOTAPE XM Reinforcement Matrix was released for sale in the U.S. and many
international markets in September 2008. The BIOTAPE XM matrix, an animal derived
(xenograft) soft-tissue graft, expands our market-leading portfolio of soft-tissue reinforcement
technologies and provides a less burdensome entrance into many of our international markets where
human tissue regulations make providing human tissue products difficult or impossible.
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
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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 via osteoinductive DBM in OSTEOSET® DBM 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, 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. 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.
Our MIIG® family of products includes MIIG® 115 graft, an injectable form of
our surgical grade calcium sulfate paste that hardens in the body; MIIG® X3 high
strength injectable graft, an injectable calcium sulfate that hardens after placement, which
provides intraoperative support and resorbs over time as it is replaced by new bone; and
MIIG® X3 HiVisc graft, an advanced formulation of MIIG® X3 graft specially
designed for management of complex compression fractures as its modified viscosity and extended
working time reduces the potential for extravasation of material into joint spaces and provides
greater operative flexibility to the surgeon for very challenging fractures.
We sell PRO-DENSE® injectable graft in the U.S. and select international markets.
PRO-DENSE® injectable graft is a composite graft of surgical grade calcium sulfate and
calcium phosphate. In animal studies, this unique graft composite has demonstrated excellent bone
regenerative characteristics, forming new bone that is over three times stronger than the natural
surrounding bone at the 13-week time point. Beyond thirteen weeks, the regenerated bone gradually
remodels to natural bone strength. Subsequent clinical data series have demonstrated dense new bone
regeneration at an accelerated rate. Ultimately, we believe that this may bode well for patients to
return to their presurgery activity levels at a faster pace.
We have signed a supply agreement with RTI Biologics, Inc., to develop advanced xenograft implants
for use in foot and ankle surgeries. Under this agreement, we launched our
CANCELLO-PURE bone wedge line, which offers surgeons an off-the-shelf, sterile graft
with handling characteristics superior to allograft. The ease of use and time savings in the
operating room have made this product line an attractive option to foot and ankle surgeons.
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. In addition, we have
clinical and regulatory departments devoted to verifying the safety and efficacy of our products in
close collaboration with the FDA and other international regulatory
bodies. Our research and development expenses totaled $33.3 million, $28.4 million and $25.6 million in 2008, 2007 and 2006,
respectively.
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 2008, we launched the ADVANCE® BIOFOAM cancellous titanium tibial base,
which features proprietary
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bone-like titanium with a roughened texture for cementless fixation of
the implant. We also added to our PROFEMUR® hip product line by adding the
PROFEMUR® Z Revision stem and the PROFEMUR® LX Revision stem. Additionally,
we expanded our CONSERVE® family of products that incorporates anatomically-replicating
large diameter bearings by adding additional cup and head sizes.
In 2008, we launched several foot and ankle products including the 3.5mm CHARLOTTE
CLAW plating system. In addition to the foot and ankle products, we also launched
several key products in our upper extremities product line, including the EVOLVE® Elbow
Plating System, and a second generation MICRONAIL® Distal Radius Fixation System.
New products, procedures and techniques that we introduced across all product lines since 2006
include, but are not limited to, the CHARLOTTE CLAW plate, and the
A-CLASS® polyethylene liner for the LINEAGE® acetabular hip system, the
ADVANCE® STATURE femoral components, the GLADIATOR bipolar
system, the DYNASTY® acetabular cup system, the PROFEMUR® TL stem, the
EVOLVE® Proline system, the CHARLOTTE 7mm multi-use compression (MUC) screw
system, the PRO-DENSE® injectable regenerative graft, the X-REAM expandable
reamer, GRAFTJACKET® MAXSTRIP regenerative tissue matrix, ADVANCE®
BIOFOAM cancellous titanium tibial base for Total Knee Replacement, and Osteoset
XR Pellets.
Manufacturing, Facilities and Quality
We operate a state of the art manufacturing facility in Arlington, Tennessee. This facility
primarily produces orthopaedic implants and some of the related surgical instrumentation while
utilizing lean manufacturing philosophies. The majority of our biologics products and surgical
instrumentation are produced to our specifications by qualified subcontractors who serve medical
device companies.
During 2008, expansions were completed to our manufacturing and office facilities. The
manufacturing facility will adequately meet our requirements for manufacturing during the upcoming
years. A modest expansion to customer service and warehouse space is anticipated during the next
two years.
We maintain a comprehensive quality system that is certified to the European standards ISO 9001 and
ISO 13485 and to the Canadian Medical Devices Assessment System (CMDCAS). We are accredited by the
AATB and have registrations with the FDA as a medical device establishment and as a tissue
establishment. These certifications and registrations require periodic audits and inspections by
various regulatory entities to determine if we have systems in place to ensure our product is safe
and effective for its intended use and that we are compliant with applicable regulatory
requirements. The quality system exists so that management has the proper oversight, designs are
evaluated and tested, production processes are established and maintained and monitoring activities
are in place to ensure products are safe, effective and manufactured according to our
specifications. Consequently, the quality system provides the way for us to ensure we design and
build quality into our products while meeting global requirements. We are committed to meet or
exceed customer needs as we improve patient outcomes.
Supply
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,
stainless steel, various grades of high density polyethylenes and ceramics. We rely on one source
to supply us with a certain grade of cobalt chrome alloy and 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. For certain biologics products, we depend on one supplier
of DBM and cancellous bone matrix (CBM). We rely on one supplier for our GRAFTJACKET®
family of soft tissue repair and graft containment products, and one supplier for our xenograph
bone wedge product. We maintain adequate stock from these suppliers in order to meet market demand.
Sales and Marketing
Our sales and marketing efforts are focused primarily on orthopaedic surgeons, who typically are
the decision-makers in orthopaedic device purchases. We have established relationships with
surgeons, who we believe are leaders in their chosen orthopaedic specialties. These surgeons help
us design products to solve some of the most
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challenging problems facing orthopaedic surgeons
today. They also help us train other surgeons in the safe and effective use of our products and
help other surgeons perfect new surgical techniques.
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 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 380 people as of December
31, 2008. 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. However, we also directly employ a group of sales
associates in select locations throughout the U.S. Our U.S. field sales force is supported by our
Tennessee-based sales and marketing organization.
Our sales associates, independent distributors and independent sales representatives are provided
opportunities for product training throughout the year.
We believe that our success in every market sector is dependent upon having a robust and compelling
product offering, and equally as important, a dedicated, highly trained, focused sales organization
to deliver it to the customer. We currently are in the process of separating and focusing our sales
representatives in the U.S. as either large joints and upper extremities specialists or foot and
ankle specialists, with biologics being sold in all areas.
Our products are marketed internationally through a combination of direct sales offices which are
corporate subsidiaries in certain key international markets and distributors in other markets. We
have subsidiaries in France, Italy, the United Kingdom, Belgium, Germany, the Netherlands, Japan
and Canada that employ direct sales employees and in some cases use independent sales
representatives to sell our products in their respective markets. Our products are also sold in
Europe, Asia, Africa, Latin America, Australia and the Middle East using stocking distribution
partners. 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, 2008, through a combination of our direct sales offices and approximately 75 stocking
distribution partners, we have approximately 670 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 than throughout the rest of
the year as many of our products are used in elective procedures, which generally decline during
the summer months, typically resulting in selling, general and administrative expenses and research
and development expenses as a percentage of sales that are higher than throughout the rest of the
year. 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 (AAOS). 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 three-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 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 and stronger name recognition than we do. Our
ability to compete is affected by our ability to:
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develop new products and innovative technologies; |
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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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securing or maintaining adequate reimbursement from third-party payors (See Third
Party Reimbursement section below); |
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respond to competitive pressures specific to each of our geographic markets,
including our ability to enforce non-compete agreements; |
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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 focused sales representatives; and |
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maintain and establish distribution relationships. |
Intellectual Property
We currently own or have licenses to use more than 250 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 products both under patents and license agreements with
other parties. These patents have a defined life and expire from time to time.
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 and/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.
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Third-Party Reimbursement
In the U.S., 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. 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, in part, upon 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 evidence and cost-effectiveness of our products. These supportive data are
obtained from both our clinical experience and formal clinical trials. We pursue and present these
results at major scientific and medical meetings and publish them in respected, peer-reviewed
medical journals.
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 government-managed health care systems, coverage with evidence development processes,
quality initiatives, pay-for-performance, health savings accounts, prospective reimbursement and
capitation programs, group purchasing, redesign of benefits, encouragement of healthier lifestyles
and exploration of more cost-effective methods of delivering health care. All of these types of
programs can potentially impact pricing structures and, subsequently, the reimbursement for all
medical devices and associated services.
Employees
As of December 31, 2008, we employed approximately 1,250 people in the following areas: 510 in
manufacturing, 450 in sales and marketing, 150 in administration and 140 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 of this.
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, pre-clinical
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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recalling or seizing our products; or |
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withdrawing or denying approvals or clearances for our products. |
Even if regulatory approval or clearance of a product is granted, this could result in limitations
on the uses for which the product may be labeled and promoted. Further, for a marketed product, its
manufacturer and manufacturing facilities are subject to periodic review and inspection. Subsequent
discovery of problems with a product, manufacturer or facility may result in restrictions on the
product, manufacturer or facility, including withdrawal of the product from the market or other
enforcement actions.
We are currently conducting clinical studies of some of our products under an IDE. Clinical studies
must be conducted in compliance with FDA regulations, or the FDA may take enforcement action. The
data collected from these clinical studies will ultimately be used to support market clearance for
these products. There is no assurance that the FDA will accept the data from these clinical studies
or that it will ultimately allow market clearance for these products.
We are subject to various federal and state laws concerning health care fraud and abuse, including
false claims laws, anti-kickback laws and physician self-referral laws. Violations of these laws
can result in criminal and/or civil punishment, including fines, imprisonment and, in the U.S.,
exclusion from participation in government health care
programs. 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 EU, we are required to comply
with the European 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 European Medical Devices Directive, all medical
devices including active implants must qualify for CE marking. In August 2005, a European Medical
Devices Directive changed the classification of hip, knee, and shoulder implants from class IIb to
class III. The transition period for these changes began 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 have determined that 27 upclassification dossiers were necessary to retain the CE
mark certification, all of which have
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been submitted to the Notified Body as of the date of this
report. We have received approval for seven of the upclassification dossiers. There can be no
assurance that the remaining dossiers will all be approved by the September 2009 deadline.
We are involved in government investigations, the results of which may adversely impact our
business and results of operations, and lead to other government investigations or actions by other
third parties.
In December 2007, we received a subpoena from the U.S. Attorneys Office for the District of New
Jersey requesting documents for the period January 1998 through the present related to any
consulting and professional service agreements with orthopaedic surgeons in connection with hip or
knee joint replacement procedures or products. We have cooperated and intend to continue to fully
cooperate with the U.S. Department of Justice (DOJ) in this investigation. In June 2008, our
principal operating subsidiary, Wright Medical Technology, Inc., received letters from the SEC and
the DOJ informing us that they are conducting an informal investigation regarding potential
violations of the Foreign Corrupt Practices Act (FCPA) in the sale of medical devices in a number
of foreign countries by companies in the medical device industry. We understand that several other
medical device companies have received similar letters. We have cooperated and intend to continue
to fully cooperate with this informal investigation.
The results of these inquiries may not be known for several years. If we are found to have violated
one or more applicable laws as a result of these investigations or we otherwise must resolve the
matters, our business, financial condition and results of operations could be materially adversely
affected and we may be required to significantly change some of our existing business practices.
These pending investigations could lead to investigations by state authorities or other government
agencies. Other companies facing similar investigations have been subject to shareholder derivative
actions. In addition, these types of inquiries could increase our exposure to lawsuits by
potential whistle blowers under the federal false claims acts. We intend to review and take
appropriate actions with respect to any such investigations or proceedings; however, we cannot
assure that the costs of investigating, defending, or resolving those investigations or proceedings
would not have a material adverse effect on our results of operations, financial condition, and
cash flow.
Cooperating with these inquiries requires considerable time and significant expense. During 2008,
we incurred $7.6 million of expenses associated with these U.S. government inquiries, primarily
related to legal fees. We anticipate that future expenses related to these inquires will continue
to be significant. In addition, upon the conclusion of these inquiries, we may incur significant
expenses associated with compliance and monitoring.
In 2007, as a result of a two-year government investigation regarding potential financial
inducements paid to orthopaedic surgeons, five of our competitors entered into deferred prosecution
or non-prosecution agreements with the DOJ, and four of those companies entered into settlement
agreements with the U.S. Department of Health and Human Services, Office of the Inspector General.
If we were to incur fines or financial settlements, it is possible that they could have a material
adverse effect to our results of operations, financial condition, and cash flow.
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.
We obtain premarket clearance under Section 510(k) of the FDC Act for products we market in the U.S
as required. We 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) modification. 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.
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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 source to supply us with a certain grade of cobalt chrome alloy and one supplier for
the silicone elastomer used in some of 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.
Further, we rely on one supplier for our GRAFTJACKET® family of soft tissue repair and
graft containment products. In order to remain an exclusive distributor of this material, we must
achieve minimum two-year compound annual growth rates. While we
have achieved the required minimums in past years, no assurances can be made that we will maintain
the required minimum growth rates. If we were to fall below the
required minimum growth rate, we have an option to preserve our
exclusivity by making an additional cash payment for the royalty
shortfall, however this payment would have an unfavorable impact on
the products cost of sales.
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 2009, we are expecting a single not-for-profit tissue
bank to meet 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 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.
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.
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If market clearance is not obtained for launch of the CONSERVE® Plus implant in the
U.S., growth of our hip product line could be impacted.
Our CONSERVE® Plus resurfacing implant is currently available only outside the U.S.
There can be no assurance that the sale of our CONSERVE® Plus product 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 hip product line.
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, European Union and Health Canada have been working to establish more comprehensive regulatory
frameworks for allograft-based, tissue-containing products, which are principally derived from
cadaveric tissue. The framework developed by the FDA establishes risk-based 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 establishment registration
requirements, product listing requirements, good tissue practice requirements for manufacturing and
screening requirements that ensure that diseases are not transmitted to tissue recipients. The FDA
has also proposed extensive additional requirements that address sub-contracted tissue services,
tracking to the recipient/patient, and donor records review. If a tissue-based product is
considered human tissue, the FDA requirements focus on preventing the introduction, transmission
and spread of communicable diseases to recipients. Clinical data or review of safety and efficacy
are not required before the tissue can be marketed. However, if it is considered a medical device
or biologic drug, then FDA clearance or approval is required.
Additionally, our biologics business involves the procurement and transplantation of allograft
tissue, which is subject to federal regulation under the National Organ Transplant Act (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.
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.
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 eight direct sales offices and approximately 75
stocking distribution partners, which combined employ approximately 670 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, 2008 and 2007, 39% 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 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; and |
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exposure to different legal and political standards due to our conducting business in over
60 countries. |
As a U.S. based company doing business in foreign jurisdictions, not only are we subject to the
laws of other jurisdictions, we are also subject to U.S. laws governing our activities in foreign
countries, such as the FCPA, as well as various import-export laws, regulations, and embargoes. If
our business activities were determined to violate these laws, regulations or rules, we could
suffer serious consequences.
Any material decrease in our foreign sales may 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.
The collectibility of our accounts receivable may be affected by general economic conditions.
Our liquidity is dependent on, among other things, the collection of our accounts receivable.
Collections of our receivables may be affected by general economic conditions. Although current
economic conditions have not had a material adverse effect on our ability to collect such
receivables, we can make no assurances regarding future economic conditions or their effect on our
ability to collect our receivables.
As of December 31, 2008, our accounts receivable balance totaled $102.0 million, and one customer,
our stocking distributor in Turkey, accounted for more than 10% of accounts receivable. As of
December 31, 2008 and 2007, the balance due from this customer was $10.6 million, or 10.4% of our
accounts receivable balance, and $8.0 million or 9.5% of our accounts receivable balance,
respectively. There were no customers that accounted for more than 10% of accounts receivable as of
December 31, 2007.
Recent turmoil in the credit markets and the financial services industry may negatively impact our
business.
Recently, the credit markets and the financial services industry have been experiencing a period of
unprecedented turmoil and upheaval characterized by the bankruptcy, failure, collapse or sale of
various financial institutions and an unprecedented level of intervention from the U.S. and foreign
governments. While the ultimate outcome of these events cannot be predicted, they may have an
adverse effect on our customers ability to borrow money from their existing lenders or to obtain
credit from other sources to purchase our products. In addition, the recent economic crisis could
also adversely impact our suppliers ability to provide us with materials and components, either of
which may negatively impact our business.
Efforts to enhance our corporate compliance program require the cooperation of many individuals and
may divert substantial financial and human resources from our other business activities.
We are committed to enhancing our corporate compliance program. This will require additional
financial and human resources. Successful implementation of our enhanced corporate compliance
program will require the full and sustained cooperation of our employees, distributors, and sales
agents as well as the health care professionals with whom they interact. These efforts will not
only require increased expenses, but will also require the time and attention
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from management and
key employees preventing them from devoting as much time as they might otherwise spend on other
business matters.
Recent acquisitions and efforts to acquire and integrate other companies or product lines could
adversely affect our operations and financial results.
In April 2008, we announced the completion of the acquisition of Inbone Technologies, Inc. In June
2008, we announced the acquisition of the foot and ankle product assets of A.M. Surgical, Inc.
Additionally, in September 2008, we completed the acquisition of the complex wrist construction
assets of Creative Medical Designs, Inc. and
Rayhack, LLC. 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. With respect to the acquisitions
completed or other future 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, any future acquisitions could materially impair our operating results by causing us to
incur debt or requiring us to amortize acquired assets.
Recent restructuring efforts could adversely affect our operations and financial results.
In June 2007, we announced plans to close our manufacturing, distribution, and administrative
facility located in Toulon, France. The facilitys closure affected approximately 130 Toulon-based
employees. The majority of our restructuring activities were complete by the end of 2007, with
Toulons production being transferred to our existing manufacturing facility in Arlington,
Tennessee and its distribution activities being transferred to our European headquarters in
Amsterdam, the Netherlands. With respect to the restructuring activities in process, we may
experience:
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higher costs of restructuring than we anticipated; |
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difficulties in completing all restructuring activities within the budgeted time; or |
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diversion of our managements time and attention from other business concerns. |
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.
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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.
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, pay ongoing royalties, 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.
In late 2004 and early 2005, approximately 120 plaintiffs sued Dr. John King in the Circuit Court
of Putnam County, West Virginia. Plaintiffs allege that Dr. King was professionally negligent when
he performed surgery on the plaintiffs at Putnam General Hospital in Putnam County, West Virginia
between November 2002 and June 2003. In 33 of the lawsuits, plaintiffs alleged that Dr. King
inappropriately used a biologic product sold by us. In these lawsuits, plaintiffs named Wright as a
defendant and allege that our products had not been properly cleared by the FDA, that we failed to
warn that our products were not safe for their intended use, and that we knew that Dr. King was not
properly trained or was performing the surgeries inappropriately. Plaintiffs also allege that we
and two other co-defendants entered into a joint venture with Dr. King and/or his physician
assistant, David McNair, such that we could be held liable for his/their conduct. Plaintiffs
further assert claims based on strict liability, express and implied breach of warranty, civil
conspiracy and negligence. They seek damages related to alleged lost income, medical expenses,
future medical and life care expenses, damages relating to pain and suffering and punitive and
other damages.
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In July 2007, a Putnam County jury found that Putnam General Hospital had negligently credentialed
Dr. King and that the hospitals conduct in credentialing Dr. King was motivated by fraud, ill
will, wantonness, oppressiveness, or by reckless or gross negligence, which allowed the plaintiffs
to seek punitive damages against the hospital. In the second quarter of 2008, the hospital, its
affiliates and David McNair entered into confidential settlements of all claims with all but one of
the plaintiffs. EBI, LLC (a subsidiary of Biomet, Inc.), Wright, an independent contractor of one
of our distributors, and Dr. King remain as defendants in the litigation.
The first consolidated trial of six plaintiffs is scheduled to begin in the Putnam County Circuit
Court in June 2009. We have product liability insurance which may or may not cover some or all of
the ultimate resolution of this litigation. While we believe our legal and factual defenses to
these claims are strong, and will continue to vigorously
defend against these claims, it is possible that the outcome of these cases will have a material
adverse effect on our consolidated financial position or results of operations.
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.
Our inability to maintain adequate working relationships with healthcare professionals could have a
negative impact on the Companys future operating results.
We maintain close working relationships with respected physicians and medical personnel in
hospitals and universities who assist in product research and development. We continue to place
emphasis on the development of proprietary products and product improvements to complement and
expand our existing product lines. If we are unable to maintain these relationships, our ability to
market and sell new and improved products could decrease, and future operating results could be
unfavorably affected.
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. |
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.
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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 who 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. Additionally, there is some likelihood of
reform of the U.S. healthcare system, and changes in reimbursement
policies or healthcare cost containment initiatives that limit or
restrict reimbursement for our products may cause our revenues to
decline.
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 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.
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
sales distributors in the past, which adversely affected short-term financial results while we
transitioned to new independent sales 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.
Fluctuations in insurance cost and availability could adversely affect our profitability or our
risk management profile.
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. Likewise, if the availability of any of
our current insurance coverage should become unavailable to us or become
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economically impractical,
we would be required to operate our business without indemnity from commercial insurance providers.
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.
If a natural or man-made disaster strikes our manufacturing facility, we could be unable to
manufacture our products for a substantial amount of time and our sales could decline.
We principally rely on a single manufacturing facility in Arlington, Tennessee. The Arlington
facility 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 facility may be affected
by natural or man-made disasters. In the event our facility is affected by a disaster, we would be
forced to rely on third-party manufacturers. 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.
Because 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.
Approximately 28% of our total net sales were denominated in foreign currencies during the years
ended December 31, 2008 and 2007, and we expect that foreign currencies will continue to represent
a similarly significant percentage of our net sales in the future. In 2008 and 2007, our
international net sales were favorably affected by the impact of foreign currency fluctuations
totaling approximately $7.9 million and $6.1 million, respectively. Operating costs related to
these sales are largely denominated in the same respective currencies, thereby partially limiting
our transaction risk exposure. However, cost of sales related to these sales are primarily
denominated in U.S. dollars; therefore, as the U.S. dollar strengthens, the gross margin associated
with our sales denominated in foreign currencies experience declines.
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 Statement of Financial Accounting Standards (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. We have not
historically entered into hedging activities to mitigate the risk of foreign currency fluctuations
in our statement of operations.
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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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increased competition; |
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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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prevailing interest rates on our excess cash investments; |
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fluctuations in foreign currency rates; |
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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; |
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changes in accounting policies, estimates, and treatments; |
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restructuring and other charges; |
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variations in cost of sales due to the amount and timing of excess and obsolete inventory
charges, commodity prices, and manufacturing variances; |
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income tax fluctuations; 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.
Conversion of our convertible senior notes into common stock could result in dilution to our
stockholders.
Our convertible senior notes are convertible at the option of the holder, subject to certain
conditions into shares of our common stock at an initial conversion price of approximately $32.65
per share, subject to adjustment, at any time before close of business on the business day
preceeding December 1, 2014, the maturity date of the notes. Beginning December 6, 2011, we may
redeem the notes for cash, in whole or in part, at a redemption price equal to 100% of the
principal amount of the notes to be redeemed, plus any accrued and unpaid interest, if the closing
sales price of our common stock has exceeded 140% of the conversion price for at least 20 trading
days in any 30-day trading period. In addition, if we experience a fundamental change event, as
defined in the note agreement, we may be required to purchase for cash all or a portion of the
notes, at a price equal to 100% of the principal amount of the notes plus any
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unpaid and accrued
interest. Additionally, if upon a fundamental change event a holder elects to convert its notes, we
may, under certain circumstances, increase the conversion rate for the notes surrendered. All of
the above rights are subject to certain limitations imposed by our credit facility. Any issuance of
shares as a result of the conversion of the notes would result in dilution to our stockholders.
We may be prohibited from paying the convertible senior notes when they are due, or be unable to
raise the funds necessary to repay the notes when due or finance a fundamental change purchase.
At maturity, the entire outstanding principal amount of our convertible senior notes will become
due and payable. In addition, upon the occurrence of a fundamental change event, holders of notes
may require us to purchase their notes. A fundamental change event includes (1) a change in
ownership, (2) a consummation of a recapitalization, reclassification, or change of common stock,
share exchange or a consolidation or merger, (3) the first day the majority of our board of
directors does not consist of continuing directors, (4) stockholder approval of any plan or
proposal for liquidation of us or (5) when our common stock ceases to be listed on the national
securities exchange in the United States, except as a result of a merger, tender offer, or exchange
offer for our common stock. Additionally, the principal amount of our convertible notes will become
due upon an uncured or unwaived default in our senior credit facility. However, we may not have
sufficient funds to repay the notes at maturity or to make the required purchase of the notes.
In addition, our ability to pay the notes at maturity or to purchase the notes upon a fundamental
change event may be limited by the terms of other agreements relating to our debt outstanding at
the time, including our revolving credit facility, which limits our ability to purchase the notes
for cash in certain circumstances. Our revolving credit facility prohibits us from making any cash
payments for the purchase of the notes upon the occurrence of a fundamental change event, and hence
we may not be able to purchase the notes for cash upon the occurrence of a fundamental change event
unless the revolving credit facility is amended to eliminate these restrictions or is no longer
outstanding at the time of such required payment. Any of our future debt agreements may contain
similar restrictions. Our failure to purchase tendered notes at a time when the purchase is
required by the indenture would constitute a default under the indenture, which in turn would
constitute an event of default under our revolving credit facility or under the other future
agreements governing our indebtedness at such time. If the repayment of the related indebtedness
were to be accelerated after any applicable notice or grace periods, we may not have sufficient
funds to repay the indebtedness or purchase the notes.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
Our corporate headquarters and U.S. operations consist of a manufacturing facility, a warehouse,
and an administration building with research and development facilities located on more than 50
acres in Arlington, Tennessee. We lease the manufacturing facility from the Industrial Development
Board of the Town of Arlington (IDB) under a lease agreement that 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 also own a small facility in Arlington used for
preproduction engineering and general production. 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 portion of
the administration building from the IDB under a lease agreement that expires on July 8, 2011. 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 prepaid, at any time during the lease term. We own another
portion of the administrative building that was built in 2004.
During 2008, expansions were completed to our manufacturing and office facilities. The
manufacturing facility will adequately meet our requirements for manufacturing during the upcoming
years. A modest expansion to customer service and warehouse space is anticipated during the next
two years.
24
Our international operations include warehouse, sales, research and development and administrative
facilities located in several countries. Our primary international warehouse is located in a leased
facility in the Netherlands. Our primary international research and development facility is located
in leased facilities in Milan, Italy. Our sales offices in France, Italy, the United Kingdom,
Germany, Belgium, Japan and Canada also include warehouse and
administrative space.
Item 3. Legal Proceedings.
From time to time, we are subject to lawsuits and claims that 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.
In 2000, Howmedica Osteonics Corp. (Howmedica), 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 are vigorously
defending this lawsuit. In November 2005, the District Court issued a Markman ruling on claim
construction. Howmedica conceded to the District Court that, if the claim construction as issued
was applied to our knee product line, our products do not infringe their patent. Howmedica appealed
the Markman ruling. In September 2008, the U.S. Court of Appeals for the Federal Circuit overturned
the District Courts Markman ruling on claim construction. The case was remanded to the District
Court for further proceedings on alleged infringement and on our affirmative defenses, which
include patent invalidity and unenforceability. 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, 2008. These 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 our consolidated financial position or results of operations however, it is
possible.
In late 2004 and early 2005, approximately 120 plaintiffs sued Dr. John King in the Circuit Court
of Putnam County, West Virginia. Plaintiffs allege that Dr. King was professionally negligent when
he performed surgery on the plaintiffs at Putnam General Hospital in Putnam County, West Virginia
between November 2002 and June 2003. In 33 of the lawsuits, plaintiffs alleged that Dr. King
inappropriately used a biologic product sold by us. In these lawsuits, plaintiffs named Wright as a
defendant and allege that our products had not been properly cleared by the FDA, that we failed to
warn that our products were not safe for their intended use, and that we knew that Dr. King was not
properly trained or was performing the surgeries inappropriately. Plaintiffs also allege that we
and two other co-defendants entered into a joint venture with Dr. King and/or his physician
assistant, David McNair, such that we could be held liable for his/their conduct. Plaintiffs
further assert claims based on strict liability, express and implied breach of warranty, civil
conspiracy and negligence. They seek damages related to alleged lost income, medical expenses,
future medical and life care expenses, damages relating to pain and suffering and punitive and
other damages.
In July 2007, a Putnam County jury found that Putnam General Hospital had negligently credentialed
Dr. King and that the hospitals conduct in credentialing Dr. King was motivated by fraud, ill
will, wantonness, oppressiveness, or by reckless or gross negligence, which allowed the plaintiffs
to seek punitive damages against the hospital. In the second quarter of 2008, the hospital, its
affiliates and David McNair entered into confidential settlements of all claims with all but one of
the plaintiffs. EBI, LLC (a subsidiary of Biomet, Inc.), Wright, an independent contractor of one
of our distributors, and Dr. King remain as defendants in the litigation.
The first consolidated trial of six plaintiffs is scheduled to begin in the Putnam County Circuit
Court in June 2009. We have product liability insurance which may or may not cover some or all of
the ultimate resolution of this litigation. While we believe our legal and factual defenses to
these claims are strong, and will continue to vigorously defend against these claims, it is
possible that the outcome of these cases will have a material adverse effect on our consolidated
financial position or results of operations.
25
Item 4. Submission of Matters to a Vote of Security Holders.
Not applicable.
26
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 Global Select Market under the symbol WMGI. The
following table sets forth, for the periods indicated, the high and low sales prices per share of
our common stock as reported on the Nasdaq Global Select Market.
|
|
|
|
|
|
|
|
|
|
|
High |
|
Low |
Fiscal Year 2008 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
29.98 |
|
|
$ |
21.06 |
|
Second Quarter |
|
$ |
31.49 |
|
|
$ |
23.53 |
|
Third Quarter |
|
$ |
33.26 |
|
|
$ |
28.00 |
|
Fourth Quarter |
|
$ |
30.71 |
|
|
$ |
15.18 |
|
Fiscal Year 2007 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
23.49 |
|
|
$ |
20.97 |
|
Second Quarter |
|
$ |
25.79 |
|
|
$ |
21.82 |
|
Third Quarter |
|
$ |
28.51 |
|
|
$ |
23.50 |
|
Fourth Quarter |
|
$ |
31.80 |
|
|
$ |
24.80 |
|
Holders
As of February 13, 2009, there were 561 stockholders of record and an estimated 10,473 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.
Equity Compensation Plan Information
The table below sets forth information regarding the number of securities to be issued upon the
exercise of the outstanding stock options granted under our equity compensation plans and the
shares of common stock remaining available for future issuance under our equity compensation plans
as of December 31, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of securities |
|
|
|
|
|
|
|
|
|
|
|
remaining available for |
|
|
|
Number of securities |
|
|
|
|
|
|
future issuance under |
|
|
|
to be issued upon exercise |
|
|
Weighted-average |
|
|
equity compensation |
|
|
|
of outstanding options |
|
|
exercise price of |
|
|
plans |
|
|
|
(in thousands) |
|
|
outstanding options |
|
|
(in thousands) |
|
Plan Category |
|
|
|
|
|
|
|
|
|
Equity compensation
plans approved by
security holders |
|
|
4,046 |
|
|
$ |
24.32 |
|
|
|
1,058 |
|
Equity compensation
plans not approved
by security holders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
4,046 |
|
|
$ |
24.32 |
|
|
|
1,058 |
|
|
|
|
|
|
|
|
|
|
|
27
Comparison of Total Stockholder Returns
The graph below compares the cumulative total stockholder returns for the period from December 31,
2003 to December 31, 2008, for our common stock, an index composed of U.S. companies whose stock is
listed on the Nasdaq Global Select Market (the Nasdaq U.S. Companies Index), and an index
consisting of Nasdaq-listed companies in the surgical, medical, and dental instruments and supplies
industry (the Nasdaq Medical Equipment Companies Index). The graph assumes that $100.00 was
invested on December 31, 2003, in our common stock, the Nasdaq U.S. Companies Index, and the Nasdaq
Medical Equipment Companies Index, and that all dividends were reinvested. Total returns for the
two Nasdaq indices are weighted based on the market capitalization of the companies included
therein. Historic stock price performance is not indicative of future stock price performance. We
do not make or endorse any prediction as to future stock price performance.
Cumulative Total Stockholder Returns
Based on Reinvestment of $100.00 Beginning on December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12/31/2003 |
|
|
12/31/2004 |
|
|
12/31/2005 |
|
|
12/31/2006 |
|
|
12/31/2007 |
|
|
12/31/2008 |
|
Wright Medical Group, Inc. |
|
$ |
100.00 |
|
|
$ |
93.76 |
|
|
$ |
67.11 |
|
|
$ |
76.57 |
|
|
$ |
95.94 |
|
|
$ |
67.20 |
|
Nasdaq U.S. Companies Index |
|
|
100.00 |
|
|
|
108.84 |
|
|
|
111.16 |
|
|
|
122.11 |
|
|
|
132.42 |
|
|
|
63.80 |
|
Nasdaq Medical Equipment
Companies Index |
|
|
100.00 |
|
|
|
117.16 |
|
|
|
128.63 |
|
|
|
135.58 |
|
|
|
172.38 |
|
|
|
92.84 |
|
Comparison of 5 Year Cumulative Total Return
Assumes Initial Investment of $100
December 31, 2008
Copyright 2009: CRSP Center for Research in Security Prices, University of Chicago, Booth School of
Business. Zacks Investment Research, Inc. Used with permission. All rights reserved.
28
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 was derived from our
consolidated financial statements audited by KPMG LLP. The audited consolidated financial
statements as of December 31, 2008, 2007, and 2006, and for the years then ended, are included
elsewhere in this annual report. The audited consolidated financial statements as of December 31,
2005 and 2004, 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Statement of Operations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
465,547 |
|
|
$ |
386,850 |
|
|
$ |
338,938 |
|
|
$ |
319,137 |
|
|
$ |
297,539 |
|
Cost of sales (1) |
|
|
134,377 |
|
|
|
108,407 |
|
|
|
97,234 |
|
|
|
91,752 |
|
|
|
84,251 |
|
Cost of sales restructuring (2) |
|
|
|
|
|
|
2,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
331,170 |
|
|
|
276,304 |
|
|
|
241,704 |
|
|
|
227,385 |
|
|
|
213,288 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
(1) |
|
|
261,396 |
|
|
|
225,929 |
|
|
|
192,573 |
|
|
|
167,365 |
|
|
|
152,508 |
|
Research and development (1) |
|
|
33,292 |
|
|
|
28,405 |
|
|
|
25,551 |
|
|
|
22,289 |
|
|
|
18,478 |
|
Amortization of intangible assets |
|
|
4,874 |
|
|
|
3,782 |
|
|
|
4,149 |
|
|
|
4,250 |
|
|
|
3,889 |
|
Restructuring charges (2) |
|
|
6,705 |
|
|
|
16,734 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and
development costs (3) |
|
|
2,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
308,757 |
|
|
|
274,850 |
|
|
|
222,273 |
|
|
|
193,904 |
|
|
|
174,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
22,413 |
|
|
|
1,454 |
|
|
|
19,431 |
|
|
|
33,481 |
|
|
|
38,413 |
|
Interest expense (income), net |
|
|
2,181 |
|
|
|
(1,252 |
) |
|
|
(1,127 |
) |
|
|
(176 |
) |
|
|
1,064 |
|
Other (income) expense, net |
|
|
(1,338 |
) |
|
|
375 |
|
|
|
(1,643 |
) |
|
|
237 |
|
|
|
(74 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
21,570 |
|
|
|
2,331 |
|
|
|
22,201 |
|
|
|
33,420 |
|
|
|
37,423 |
|
Provision for income taxes |
|
|
18,373 |
|
|
|
1,370 |
|
|
|
7,790 |
|
|
|
12,355 |
|
|
|
13,401 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
3,197 |
|
|
$ |
961 |
|
|
$ |
14,411 |
|
|
$ |
21,065 |
|
|
$ |
24,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.09 |
|
|
$ |
0.03 |
|
|
$ |
0.42 |
|
|
$ |
0.62 |
|
|
$ |
0.72 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.09 |
|
|
$ |
0.03 |
|
|
$ |
0.41 |
|
|
$ |
0.60 |
|
|
$ |
0.68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares
outstanding basic |
|
|
36,933 |
|
|
|
35,812 |
|
|
|
34,434 |
|
|
|
33,959 |
|
|
|
33,391 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares
outstanding diluted |
|
|
37,401 |
|
|
|
36,483 |
|
|
|
35,439 |
|
|
|
35,199 |
|
|
|
35,317 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2008 |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
Consolidated Balance
Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
87,865 |
|
|
$ |
229,026 |
|
|
$ |
57,939 |
|
|
$ |
51,277 |
|
|
$ |
83,470 |
|
Marketable securities |
|
|
57,614 |
|
|
|
15,535 |
|
|
|
30,325 |
|
|
|
25,000 |
|
|
|
|
|
Working capital |
|
|
401,406 |
|
|
|
417,817 |
|
|
|
220,306 |
|
|
|
196,126 |
|
|
|
189,803 |
|
Total assets |
|
|
692,130 |
|
|
|
669,985 |
|
|
|
409,402 |
|
|
|
371,810 |
|
|
|
361,158 |
|
Long-term liabilities |
|
|
205,253 |
|
|
|
207,820 |
|
|
|
14,162 |
|
|
|
15,547 |
|
|
|
19,870 |
|
Stockholders equity |
|
|
411,628 |
|
|
|
388,781 |
|
|
|
335,824 |
|
|
$ |
292,008 |
|
|
|
276,069 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2008 |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
Other Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow (used in) provided by
operating activities |
|
$ |
(3,610 |
) |
|
$ |
24,424 |
|
|
$ |
29,975 |
|
|
$ |
5,291 |
|
|
$ |
37,365 |
|
Cash flow used in investing activities |
|
|
(148,942 |
) |
|
|
(63,841 |
) |
|
|
(28,349 |
) |
|
|
(31,583 |
) |
|
|
(18,428 |
) |
Cash flow provided by (used in)
financing activities |
|
|
12,406 |
|
|
|
209,897 |
|
|
|
4,646 |
|
|
|
(5,379 |
) |
|
|
(2,305 |
) |
Depreciation |
|
|
26,462 |
|
|
|
23,522 |
|
|
|
21,361 |
|
|
|
17,895 |
|
|
|
17,278 |
|
Stock-based compensation expense
(4) |
|
|
13,501 |
|
|
|
16,532 |
|
|
|
13,840 |
|
|
|
467 |
|
|
|
1,489 |
|
Capital expenditures(5) |
|
|
61,936 |
|
|
|
35,042 |
|
|
|
29,643 |
|
|
|
30,356 |
|
|
|
18,316 |
|
|
|
|
(1) |
|
These line items include the following amounts of non-cash stock-based compensation expense
for the periods indicated: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2008 |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
Cost of sales |
|
$ |
1,244 |
|
|
$ |
2,046 |
|
|
$ |
854 |
|
|
$ |
12 |
|
|
$ |
68 |
|
Selling, general and
administrative |
|
|
10,644 |
|
|
|
12,061 |
|
|
|
10,766 |
|
|
|
449 |
|
|
|
1,364 |
|
Research and development |
|
|
1,613 |
|
|
|
2,425 |
|
|
|
2,220 |
|
|
|
6 |
|
|
|
57 |
|
|
|
|
(2) |
|
During the years ended December 31, 2008 and 2007, we recorded pre-tax charges associated
with the restructuring of our facilities in Toulon, France, totaling $6.7 million and $18.9
million, respectively. See Note 16 to our consolidated financial statements contained in
Financial Statements and Supplementary Data for a detailed discussion of these activities
and the associated charges. |
|
(3) |
|
During the year ended December 31, 2008, we recorded $2.5 million of in-process research and
development charges associated with our acquisition of Inbone Technologies, Inc. See Note 3 to
our consolidated financial statements contained in Financial Statements and Supplementary
Data for a detailed discussion of this acquisition. |
|
(4) |
|
Effective January 1, 2006, we adopted SFAS No. 123 (Revised 2004), Share-Based Payment
(SFAS 123R), which requires stock-based compensation costs to be measured using the grant date
fair value and recognized as expense over the related service period. We elected the modified
prospective method of transition, under which prior periods were not revised for comparative
purposes. As a result, 2008, 2007 and 2006 amounts are not comparable to prior years. |
|
(5) |
|
During the year ended December 31, 2008, our capital expenditures included approximately
$16.9 million related to the expansion of our Arlington, Tennessee facilities. |
30
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 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 in our consolidated statement of operations. |
|
|
|
Results of operations. This section provides our analysis of and outlook for the
significant line items in our consolidated statement of operations. |
|
|
|
Seasonal nature of business. This section describes the effects of seasonal fluctuations in
our business. |
|
|
|
Restructuring. This section discusses our restructuring activities and the future impact to
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 Financial Statements and Supplementary Data. |
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 or have been
damaged 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. 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 research and development, manufacturing, warehousing and administrative activities. Outside
the U.S., we have research, distribution and administrative facilities in Milan, Italy;
distribution and administrative facilities in Amsterdam, the Netherlands; 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
1,050 individuals who promote our products to orthopaedic surgeons and hospitals. At the end of
2008, we had approximately 380 sales associates and independent sales distributors in the U.S., and
approximately 670 sales representatives internationally, who were employed through a combination of
our stocking distribution partners and direct sales offices.
Principal Products. We primarily sell reconstructive joint devices and biologics products. Our
reconstructive joint device sales are derived from three primary product lines: knees, hips and
extremities. Our biologics sales encompass 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.
31
Our knee reconstruction products position us well in the areas of total knee reconstruction,
revision replacement implants and limb preservation products. Our principal knee product is the
ADVANCE® knee system.
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® family
of hip stems, the LINEAGE® acetabular system, the ANCA-FIT hip system, the
PERFECTA® hip system and the DYNASTY acetabular cup system.
Our extremities product line includes products for both the foot and ankle and the upper extremity
markets. Our principal foot and ankle portfolio includes the CHARLOTTE foot and ankle
system, the DARCO® MFS, DARCO® MRS, and DARCO® FRS locked plating
systems, the INBONE Total Ankle System, the INBONE Intra-osseous Fusion Rod
and Plate System, and the SIDEKICK external fixation systems. Our upper extremity
portfolio includes the MICRONAIL® intramedullary wrist fracture repair system, as well
as the SWANSON line of finger and the ORTHOSPHERE® carpometacarpal implant for repair of
the basal thumb joint.
Our biologics products focus on biological musculoskeletal repair and include synthetic and human
tissue-based materials. Our principal biologics products include the GRAFTJACKET® line
of soft tissue repair and containment membranes, the ALLOMATRIX® line of injectable
tissue-based bone graft substitutes, the PRO-DENSE® injectable regenerative graft, the
OSTEOSET® synthetic bone graft substitute, the MIIG® family of minimally
invasive, injectable, synthetic bone grafts, and the CANCELLO-PURE wedge products.
Significant Business Developments. Net sales grew 20% in 2008, totaling $465.5 million, compared to
$386.9 million in 2007. Our knee, hip, biologics and extremity product lines each contributed
significantly to our performance in 2008, achieving 17%, 20%, 8% and 43% growth rates,
respectively. Our net income increased to $3.2 million in 2008 from $1.0 million in 2007, as
increased profitability from higher levels of sales and decreased restructuring charges were mostly
offset by $7.6 million ($4.7 million net of taxes) of costs associated with the ongoing U.S.
governmental inquiries, the write-off of $2.5 million of acquired in-process research and
development charges and a tax provision of $12.8 million to
adjust our valuation allowance, primarily for deferred tax assets associated with
net operating losses in France.
In April 2008, we announced the acquisition of INBONE Technologies, Inc. (Inbone). Assets acquired
include the INBONE Total Ankle System and the INBONE Intra-osseous Fusion
Rod and Plate System. In June 2008, we announced the acquisition of the endoscopic soft tissue
release products for the foot and ankle market of A.M. Surgical, Inc. In September 2008, we
completed the acquisition of all assets associated with the RAYHACK® Osteotomy Systems
for complex wrist reconstruction. Each of these acquisitions adds key products to our extremities
business. See Note 3 to our consolidated financial statements contained in Financial Statements
and Supplementary Data for further discussion of our acquisitions.
During 2008, we grew in all of our domestic product lines. Most significantly, our domestic
extremity business experienced year-over-year growth totaling 47%, as a result of the continued
success of our CHARLOTTE foot and ankle system and our DARCO® plating
systems, as well as the product sales from our acquisitions noted above. We anticipate that growth
within our domestic extremities business will continue to increase, as sales of our
CHARLOTTE, DARCO®, and INBONE products continue to increase and
as we continue to expand our extremity product offerings.
Our international sales increased by 21% during 2008 as compared to 2007. This increase was driven
by growth in substantially all of our major international markets. In addition, our 2008
international sales included a $7.9 million favorable currency impact compared to 2007.
32
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 United States Food and Drug Administration
(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. We devote significant
resources to assessing and analyzing competitive, regulatory and economic risks and opportunities.
In December 2007, we received a subpoena from the U.S. Attorneys Office for the District of New
Jersey requesting certain documents related to consulting agreements with orthopaedic surgeons.
This subpoena was served shortly after several of our knee and hip competitors agreed to
resolutions with the U.S. Department of Justice (DOJ) after being subjects of investigation
involving the same subject matter. We continue to cooperate fully with the investigation by the
DOJ, and we anticipate that we may continue to incur significant expenses related to this inquiry.
In June 2008, we received a letter from the U.S. Securities and Exchange Commission (SEC) informing
us that it is conducting an informal investigation regarding potential violations of the Foreign
Corrupt Practices Act in the sale of medical devices in a number of foreign countries by companies
in the medical device industry. We understand that several other medical device companies have
received similar letters. We are cooperating fully with the SEC inquiry.
A detailed discussion of these and other factors is provided in Risk Factors.
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 MD&A Executive
Overview.
Cost of sales. Our cost of sales consists primarily of direct labor, allocated manufacturing
overhead, raw materials and components, non-cash stock-based compensation, charges incurred for
excess and obsolete inventories, royalty expenses associated with licensing technologies used in
our products or processes and certain other period expenses.
Cost of sales restructuring. These expenses primarily consist of in-process inventories in our
Toulon, France, manufacturing facility that were written off, as well as other unfavorable
manufacturing expenses in the Toulon facility that were expensed as period costs in accordance with
Financial Accounting Standards Board (FASB) Statement No. 151, Inventory Costs, an Amendment of ARB
No. 43, Chapter 4 (SFAS 151).
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 settlements and judgments and the related
costs, non-cash, stock-based compensation, other general business and administrative expenses and
depreciation expense associated with reusable surgical instruments that are used to implant 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.
33
Amortization of intangible assets. Our intangible assets consist of purchased intangibles related
to completed technology, distribution channels, trademarks, product licenses, customer
relationships and non-compete agreements. We amortize intangible assets over periods ranging from
one to 15 years.
Acquired in-process research and development. Acquired in-process research and development
represents the fair value of acquired in-process research and development (IPRD) that had not yet
reached technological feasibility and had no alternative future use.
Interest expense (income), net. Interest expense (income), net, consists primarily of income
generated by our invested cash balances and investments in marketable securities, offset by
interest expense on our convertible senior notes, borrowings outstanding under our previous 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 current and previous senior credit facilities and the issuance of our
convertible debt.
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, changes in estimates related
to our valuation allowances recorded against our net deferred tax assets, and the recognition of
non-cash, stock-based compensation expense, a significant portion of which may not be deductible
under U.S. and foreign tax regulations.
Results of Operations
Comparison of the year ended December 31, 2008 to the year ended December 31, 2007
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, |
|
|
|
2008 |
|
|
2007 |
|
|
|
Amount |
|
|
% of Sales |
|
|
Amount |
|
|
% of Sales |
|
Net sales |
|
$ |
465,547 |
|
|
|
100.0 |
% |
|
$ |
386,850 |
|
|
|
100.0 |
% |
Cost of sales |
|
|
134,377 |
|
|
|
28.9 |
% |
|
|
108,407 |
|
|
|
28.0 |
% |
Cost of sales restructuring |
|
|
|
|
|
|
|
|
|
|
2,139 |
|
|
|
0.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
331,170 |
|
|
|
71.1 |
% |
|
|
276,304 |
|
|
|
71.4 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
261,396 |
|
|
|
56.1 |
% |
|
|
225,929 |
|
|
|
58.4 |
% |
Research and development |
|
|
33,292 |
|
|
|
7.2 |
% |
|
|
28,405 |
|
|
|
7.3 |
% |
Amortization of intangible assets |
|
|
4,874 |
|
|
|
1.0 |
% |
|
|
3,782 |
|
|
|
1.0 |
% |
Restructuring charges |
|
|
6,705 |
|
|
|
1.4 |
% |
|
|
16,734 |
|
|
|
4.3 |
% |
Acquired in-process research and
development |
|
|
2,490 |
|
|
|
0.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
308,757 |
|
|
|
66.3 |
% |
|
|
274,850 |
|
|
|
71.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
22,413 |
|
|
|
4.8 |
% |
|
|
1,454 |
|
|
|
0.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense (income), net |
|
|
2,181 |
|
|
|
0.5 |
% |
|
|
(1,252 |
) |
|
|
(0.3 |
%) |
Other (income) expense, net |
|
|
(1,338 |
) |
|
|
(0.3 |
%) |
|
|
375 |
|
|
|
0.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
21,570 |
|
|
|
4.6 |
% |
|
|
2,331 |
|
|
|
0.6 |
% |
Provision for income taxes |
|
|
18,373 |
|
|
|
3.9 |
% |
|
|
1,370 |
|
|
|
0.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
3,197 |
|
|
|
0.7 |
% |
|
$ |
961 |
|
|
|
0.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
34
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, |
|
|
% |
|
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Hip products |
|
$ |
160,788 |
|
|
$ |
134,251 |
|
|
|
19.8 |
% |
Knee products |
|
|
119,895 |
|
|
|
102,334 |
|
|
|
17.2 |
% |
Extremity products |
|
|
88,890 |
|
|
|
62,302 |
|
|
|
42.7 |
% |
Biologics products |
|
|
82,399 |
|
|
|
76,029 |
|
|
|
8.4 |
% |
Other |
|
|
13,575 |
|
|
|
11,934 |
|
|
|
13.8 |
% |
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
465,547 |
|
|
$ |
386,850 |
|
|
|
20.3 |
% |
|
|
|
|
|
|
|
|
|
|
The following graphs illustrate our product line sales as a percentage of total net sales for the
years ended December 31, 2008 and 2007:
Net sales. Our net sales growth in 2008 was attributable to the growth in each of our primary
product lines, led by our extremities product line, which increased by 43% over 2007.
Geographically, our domestic net sales totaled $282.1 million in 2008 and $235.7 million in 2007,
representing approximately 61% of total net sales in each year and a 20% increase over 2007. Our
international net sales totaled $183.5 million in 2008, a 21% increase as compared to net sales of
$151.1 million in 2007. Our 2008 international net sales included a favorable foreign currency
impact of approximately $7.9 million when compared to 2007 net sales, principally resulting from
the 2008 performance of the Japanese yen and the euro against the U.S. dollar. The remaining
increase in international sales is attributable to continued growth in Asia and our European
markets, primarily within our hip and knee product lines.
Our hip product sales totaled $160.8 million in 2008, representing a 20% increase over 2007, driven
by increased sales of our PROFEMUR® hip system, our CONSERVE® family of
products, our DYNASTY® acetabular cup system and sales of revision hip stems introduced
in the second quarter of 2008. Domestic hip sales increased 9% over 2007 due to increased unit
sales, which were partially offset by declines in average selling price. Our international hip
business increased by 21% over 2007 due to growth in almost all international markets, most notably
in Japan where hip sales increased 50%. Our international hip sales include a $5.1 million
favorable currency impact compared to 2007.
Sales of our knee products totaled $119.9 million in 2008, representing growth of 17% over 2007.
Year-over-year growth in our ADVANCE® knee systems in both our international and
domestic markets, which totaled 23% and 15%, respectively, was partially offset by declines across
our other, more mature knee
product
35
offerings. Our domestic sales increase was driven primarily by increased unit sales. Our
international knee sales include a $2.0 million favorable currency impact compared to 2007.
Our extremity product sales increased to $88.9 million in 2008, representing growth of 43% over
2007. Our domestic extremity product sales increased 47%, primarily resulting from the continued
success of our CHARLOTTE foot and ankle system and sales of our DARCO®
plating systems, as well as sales of our INBONE products acquired during the second
quarter 2008. Our international extremity product sales growth of 29% was primarily attributable
to increased sales of our DARCO® plating systems.
Net sales of our biologics products totaled $82.4 million in 2008, which represents an 8% increase
over 2007. In the U.S., biologics sales increased by 16% due to increased sales of our
PRO-DENSE® injectable regenerative graft, our GRAFTJACKET® tissue repair and
containment membranes and our CANCELLO-PURE wedge products. In our international
markets, we noted a decline in biologics sales, primarily due to the August 2007 disposition of our
Adcon®-Gel related assets and decreased biologics sales to our stocking distributor in
Turkey.
Cost of sales. In 2008, our cost of sales as a percentage of net sales increased from 28.0% in 2007
to 28.9 % in 2008. This increase is primarily attributable to unfavorable shifts in our geographic
and product line sales mix and increased raw material and other manufacturing costs, which were
partially offset by lower levels of non-cash stock-based compensation expense. Our cost of sales
included 0.3 percentage points and 0.5 percentage points of non-cash, stock-based compensation
expense in 2008 and 2007, respectively. 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.
Cost of sales restructuring. In 2007, we recorded $2.1 million, 0.6% of net sales, of charges
associated with the closure of our manufacturing facility in Toulon, France for inventory
write-offs and manufacturing costs incurred during a period of abnormal production capacity which
were expensed as period costs in accordance with SFAS 151.
Selling, general and administrative. Our selling, general and administrative expenses as a
percentage of net sales totaled 56.1% in 2008, a 2.3 percentage point decrease from 58.4% in 2007.
Approximately $10.6 million and $12.1 million of non-cash, stock-based compensation expense was
recognized in 2008 and 2007, respectively, representing 2.3% and 3.1% of net sales in each of the
years, respectively. Additionally, our 2008 selling, general and administrative expenses include
approximately $7.6 million (1.6% of net sales) of costs, primarily legal fees, associated with the
U.S. government inquiries. The decrease in selling, general and administrative expenses as a
percentage of sales was driven by lower levels of expenses due to our restructuring efforts in
Toulon, France, lower levels of professional fees, and decreased stock-based compensation, as well
as the leveraging of fixed administrative expenses, all of which were partially offset by costs
associated with the U.S. government inquiries.
We anticipate that our selling, general and administrative expenses will increase in absolute
dollars to the extent that 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 may increase as a percentage of net
sales as we make strategic investments in order to grow our business and as we continue to incur
expenses associated with the U.S. government inquiries, which we believe will continue to be
significant.
Research and development. Our investment in research and development activities represented 7.2% of
net sales in 2008, as compared to 7.3% in 2007. Non-cash, stock-based compensation expense of $1.6
million, 0.3% of net sales, was recorded in 2008 compared to $2.4 million, 0.6% of net sales,
recorded in 2007. This decrease in stock-based compensation was mostly offset by increased
investments in product development.
36
We anticipate that our research and development expenditures may increase as a percentage of net
sales and will increase 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.
Amortization of intangible assets. Charges associated with amortization of intangible assets
totaled $4.9 million in 2008, as compared to $3.8 million in 2007. The increase is attributable to
amortization for intangible assets associated with our 2008 and 2007 acquisitions. Based on the
intangible assets held at December 31, 2008, we expect to amortize approximately $4.8 million in
2009, $2.3 million in 2010, $2.2 million in 2011, $2.1 million in 2012 and $1.8 million in 2013.
Acquired In-Process Research and Development. Upon consummation of our Inbone acquisition, we
immediately recognized as expense $2.5 million in costs representing the estimated fair value of
acquired IPRD that had not yet reached technological feasibility and had no alternative future use.
The fair 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. The resulting net cash flows from the
project were based on our 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 |
|
Discount rate including |
|
|
|
|
in-flows expected |
|
factor to account for |
|
|
Project |
|
to begin |
|
uncertainty of success |
|
Acquired IPRD |
INBONE Calcaneal Stem Implant |
|
|
2009 |
|
|
|
18 |
% |
|
$ |
2,490,000 |
|
The INBONE Calcaneal Stem implant (Calcaneal Stem) is an implant device designed to
attach on the INBONE Talar Dome and achieve bone implant stability by engaging the
inside of the talar bone spanning into the calcaneal bone after the two bones have been stabilized
together. We expect this device to bring increased sales to the existing INBONE Total
Ankle System. The product is complete, but it has not yet received all the necessary FDA clearances
to bring the product into a commercially viable product. Prior to the acquisition, Inbone filed a
510(k) premarket notification for the Calcaneal Stem and had received questions from the FDA.
Subsequent to the acquisition, we received additional questions. We are currently working on a new
submission that will address these questions and anticipate that we will obtain FDA clearance no
sooner than the end of 2009. We currently do not expect to be required to provide additional
testing to support this strategy, but do expect to pay an immaterial amount of review fees.
We are continuously monitoring our research and development projects. We believe that the
assumptions used in the valuation of acquired IPRD represent a reasonably reliable estimate of the
future benefits attributable to the acquired IPRD. No assurance can be given that actual results
will not deviate from those assumptions in future periods.
Interest expense (income), net. Interest expense (income), net, consists of interest expense of
$7.0 million and $1.8 million in 2008 and 2007, respectively, primarily from borrowings under our
convertible debt issued in November 2007, our capital lease agreements, and certain of our
factoring agreements. This was partially offset by interest income of $4.8 million and $3.1 million
during 2008 and 2007, respectively, generated by our invested cash balances and investments in
marketable securities.
The amounts of interest income we realize in 2009 and beyond are subject to variability, dependent
upon both the rate of invested returns we realize and the amount of excess cash balances on hand.
37
Other (income) expense, net. Other (income) expense, net, totaled $1.3 million of income during
2008 compared to $375,000 of expense during 2007. In 2008, $900,000 of a deferred gain associated
with the 2007 disposition of our Adcon®-Gel assets was recognized and included in other
income.
Provision for income taxes. We recorded tax provisions of $18.4 million and $1.4 million in 2008
and 2007, respectively. Our effective tax rate for 2008 and 2007 was 85.2% and 58.8%, respectively.
In 2008, we recognized a tax provision of $12.8 million to adjust our valuation allowance,
primarily to record a valuation allowance against all of our remaining deferred tax assets
associated with net operating losses in France, which increased our
effective tax rate by 59 percentage points.
Comparison
of the year ended December 31, 2007 to the year ended December 31, 2006
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, |
|
|
|
2007 |
|
|
2006 |
|
|
|
Amount |
|
|
% of Sales |
|
|
Amount |
|
|
% of Sales |
|
Net sales |
|
$ |
386,850 |
|
|
|
100.0 |
% |
|
$ |
338,938 |
|
|
|
100.0 |
% |
Cost of sales |
|
|
108,407 |
|
|
|
28.0 |
% |
|
|
97,234 |
|
|
|
28.7 |
% |
Cost of sales restructuring |
|
|
2,139 |
|
|
|
0.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
276,304 |
|
|
|
71.4 |
% |
|
|
241,704 |
|
|
|
71.3 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative |
|
|
225,929 |
|
|
|
58.4 |
% |
|
|
192,573 |
|
|
|
56.8 |
% |
Research and development |
|
|
28,405 |
|
|
|
7.3 |
% |
|
|
25,551 |
|
|
|
7.5 |
% |
Amortization of intangible assets |
|
|
3,782 |
|
|
|
1.0 |
% |
|
|
4,149 |
|
|
|
1.2 |
% |
Restructuring charges |
|
|
16,734 |
|
|
|
4.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
274,850 |
|
|
|
71.0 |
% |
|
|
222,273 |
|
|
|
65.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,454 |
|
|
|
0.4 |
% |
|
|
19,431 |
|
|
|
5.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
(1,252 |
) |
|
|
(0.3 |
%) |
|
|
(1,127 |
) |
|
|
(0.3 |
%) |
Other expense (income), net |
|
|
375 |
|
|
|
0.1 |
% |
|
|
(1,643 |
) |
|
|
(0.5 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
2,331 |
|
|
|
0.6 |
% |
|
|
22,201 |
|
|
|
6.6 |
% |
Provision for income taxes |
|
|
1,370 |
|
|
|
0.4 |
% |
|
|
7,790 |
|
|
|
2.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
961 |
|
|
|
0.2 |
% |
|
$ |
14,411 |
|
|
|
4.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
% |
|
|
|
2007 |
|
|
2006 |
|
|
Change |
|
Hip products |
|
$ |
134,251 |
|
|
$ |
122,073 |
|
|
|
10.0 |
% |
Knee products |
|
|
102,334 |
|
|
|
94,079 |
|
|
|
8.8 |
% |
Extremity products |
|
|
62,302 |
|
|
|
45,044 |
|
|
|
38.3 |
% |
Biologics products |
|
|
76,029 |
|
|
|
65,455 |
|
|
|
16.2 |
% |
Other |
|
|
11,934 |
|
|
|
12,287 |
|
|
|
(2.9 |
%) |
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
386,850 |
|
|
$ |
338,938 |
|
|
|
14.1 |
% |
|
|
|
|
|
|
|
|
|
|
38
The following graphs illustrate our product line sales as a percentage of total net sales for the
years ended December 31, 2007 and 2006:
Net sales. Our net sales growth in 2007 was primarily attributable to growth in each of our primary
product lines, led by our extremities product line, which increased by 38% over 2006.
Geographically, our domestic net sales totaled $235.7 million in 2007 and $211.0 million in 2006,
representing approximately 61% and 62% of total net sales in each year, respectively, and an
increase of 12% over 2006. Our international net sales totaled $151.1 million in 2007, an 18%
increase as compared to net sales of $127.9 million in 2006. Our 2007 international net sales
included a favorable foreign currency impact of approximately $6.1 million when compared to 2006
net sales, principally resulting from the 2007 performance of the euro against the U.S. dollar. The
remaining increase in international sales is attributable to continued growth in Asia and certain
European markets, which were partially offset by declines in France and Italy.
From a product line perspective, our net sales growth for 2007 was attributable to increases in
sales across all four of our principal product lines. For 2007, we experienced growth of 38%, 16%,
10% and 9% in our extremity, biologics, hip and knee product lines, respectively. During 2007, our
extremity sales growth was attributable primarily to the continued success of our
CHARLOTTE foot and ankle system and sales of our DARCO® plating systems,
which were acquired in April 2007. The growth of our biologics business in 2007 was primarily
attributable to our GRAFTJACKET® tissue repair and containment membranes and sales of
our PRO-DENSE® injectable regenerative graft launched during the third quarter of 2007.
The increase in our hip product sales is primarily the result of international growth of 18%, led
by sales in our Asian markets. Sales of our knee products increased in 2007 compared to the prior
year as a result of growth in our ADVANCE® knee systems in both our international and
domestic markets.
Cost of sales. Our cost of sales as a percentage of net sales decreased from 28.7% in 2006 to 28.0%
in 2007. This decrease was attributable to manufacturing efficiencies in 2007, which were partially
offset by unfavorable shifts in our sales mix. Cost of sales in 2007 and 2006 included
approximately 0.5 and 0.3 percentage points of non-cash, stock-based compensation expense,
respectively. Additionally, our 2007 cost of sales included 0.1 percentage points of non-cash
inventory step-up amortization associated with our 2007 acquisitions.
Cost of sales restructuring. In 2007, we recorded $2.1 million, 0.6% of net sales, of charges
associated with the closure of our manufacturing facility in Toulon, France for inventory
write-offs and manufacturing costs incurred during a period of abnormal production capacity which
were expensed as period costs in accordance with SFAS 151.
39
Operating expenses. Our total operating expenses increased, as a percentage of net sales, by 5.4
percentage points to 71.0% in 2007. Operating expenses include selling, general and administrative
expenses, research and development expenses, amortization of intangibles and restructuring charges.
The increase in operating expenses was attributed primarily to the recognition of $16.7 million of
restructuring charges and charges associated with an unfavorable arbitration ruling related to a
dispute with a former consultant. Further contributing to this increase was increased investments
in sales and marketing activities, higher levels of cash incentive compensation, expenses
associated with our 2007 acquisitions and increased depreciation expense.
Provision for income taxes. Our effective tax rate for 2007 and 2006 was 58.8% and 35.1%,
respectively. Our 2006 effective tax rate includes a $1.1 million benefit that was realized upon
the resolution of certain foreign tax matters.
Seasonal Nature of Business
We traditionally experience lower sales volumes in the third quarter than throughout the rest of
the year as many of our products are used in elective procedures, which generally decline during
the summer months, typically resulting in selling, general and administrative expenses and research
and development expenses as a percentage of sales that are higher than throughout the rest of the
year. 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 three-day event, we display our most recent and innovative products to these
surgeons.
Restructuring
In June 2007, we announced our plans to close our facilities in Toulon, France. This announcement
came after a thorough evaluation in which we determined that we had excess manufacturing capacity
and redundant distribution and administrative resources that would be best eliminated through the
closure of this facility. The majority of our restructuring activities were complete by the end of
2007, resulting in production now being conducted solely in our existing manufacturing facility in
Arlington, Tennessee and the distribution activities being carried out from Arlington, Tennessee
and from our European headquarters in Amsterdam, the Netherlands. We have estimated that total
pre-tax restructuring charges will be approximately $28 million to $32 million, of which we have
recognized $25.6 million through December 31, 2008. We have realized, and we believe that we will
continue to see, the benefits from this restructuring within selling, general and administrative
expenses and within cost of sales in 2009. See Note 16 to our consolidated financial statements in
Financial Statements and Supplementary Data for further discussion of our restructuring charges.
Liquidity and Capital Resources
The following table sets forth, for the periods indicated, certain liquidity measures (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2008 |
|
2007 |
Cash and cash equivalents |
|
$ |
87,865 |
|
|
$ |
229,026 |
|
Short-term marketable securities |
|
|
57,614 |
|
|
|
15,535 |
|
Working capital |
|
|
401,406 |
|
|
|
417,817 |
|
Line of credit availability |
|
|
100,000 |
|
|
|
97,100 |
|
During the first quarter of 2008, we liquidated our investments in auction rate securities into
cash equivalents. During the remainder of the 2008, we invested approximately $57 million into
treasury bills,
government bonds, agency bonds and certificates of deposit with maturities of less than 12 months.
We have classified these marketable securities as available-for-sale.
40
Operating Activities. Cash used in operating activities totaled $3.6 million in 2008, as compared
to cash provided by operating activities of $24.4 million in 2007 and $30.0 million in 2006. In
2008 compared to 2007, increased profitability was offset by changes in working capital. Accounts
receivable increased due to higher levels of sales in international markets that typically have
longer collection terms. Inventories increased due to recent acquisitions and distribution
agreements, and to support higher levels of sales. Finally, in 2007, our accrued expenses increased
significantly, primarily associated with restructuring charges.
The decrease in cash provided by operating activities in 2007, compared to 2006, is primarily
attributable to lower levels of profitability in the year due to restructuring charges, which was
partially offset by changes in working capital.
Investing Activities. Our capital expenditures totaled $61.9 million in 2008, $35.0 million in 2007
and $29.6 million in 2006. The increase in 2008 compared to 2007 is attributable to $16.9 million
of expenditures related to the expansion of our Arlington, Tennessee facilities as well as
increased investments in surgical instrumentation. Our industry is capital intensive, particularly
as it relates to surgical instrumentation. Historically, our capital expenditures have consisted
principally 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 $42 million in 2009 for routine capital expenditures, as well as approximately $3
million for the planned expansion of facilities in Arlington, Tennessee.
We invested $32.3 million in acquisitions of businesses and intellectual property during 2008. We
are continuously evaluating opportunities to purchase technology and other forms of intellectual
property and are, therefore, unable to predict the likelihood or timing of future purchases, if
any.
Financing Activities. During 2008, proceeds of $12.0 million were generated from the issuance of
common stock upon exercise of stock options granted under our stock-based compensation plans. These
proceeds were offset by $285,000 in principal payments related to our long-term capital lease
obligations. 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. 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 2008, 2007 and 2006 totaled $6.6 million, $3.6 million and $5.6 million,
respectively. These proceeds were offset by payments for factored receivables collected of $7.0
million, $7.1 million and $5.7 million in 2008, 2007 and 2006, respectively. We recorded
obligations of $54,000 and $674,000 for the amount of receivables factored under these agreements
as of December 31, 2008 and 2007, respectively, which are included within Accrued expenses and
other current liabilities in our consolidated balance sheet.
In 2009, we will make continued payments under our long-term capital leases, including interest, of
$136,000 and we will make scheduled interest payments under our convertible senior notes of $5.3
million.
On December 31, 2008, our revolving credit facility had availability of $100 million, which can be
increased by up to an additional $50 million at our request and subject to the agreement of the
lenders. We currently have no borrowings outstanding under the credit facility. Borrowings under
the credit facility will bear interest at the sum of an annual base rate plus an applicable annual
rate that ranges from 0% to 1.75% depending on the type of loan and our consolidated leverage
ratio, with a current annual base rate of 3.25%. The term of the credit facility extends through
June 30, 2011.
During 2007, we issued $200 million of Convertible Senior Notes due 2014, which generated net
proceeds of $193.5 million. The notes require us to pay interest semiannually at an annual rate of
2.625%. The notes are convertible into shares of our common stock at an initial conversion rate of
30.6279 shares per $1,000 principal amount of the notes, which represents a conversion price of
$32.65 per share. We will make scheduled interest payments in 2009 related to the notes totaling
$5.3 million.
41
Contractual Cash Obligations. At December 31, 2008, we had contractual cash obligations and
commercial commitments as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Periods |
|
|
|
Total |
|
|
2009 |
|
|
2010-2011 |
|
|
2012-2013 |
|
|
After 2013 |
|
Amounts reflected in balance sheet: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligations(1) |
|
$ |
277 |
|
|
$ |
136 |
|
|
$ |
132 |
|
|
$ |
9 |
|
|
$ |
|
|
Convertible senior notes(2) |
|
|
200,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200,000 |
|
Contingent consideration |
|
|
3,675 |
|
|
|
2,000 |
|
|
|
1,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts not reflected in balance sheet: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases |
|
|
18,254 |
|
|
|
8,377 |
|
|
|
8,418 |
|
|
|
1,012 |
|
|
|
447 |
|
Interest on convertible senior notes(3) |
|
|
31,063 |
|
|
|
5,250 |
|
|
|
10,500 |
|
|
|
10,500 |
|
|
|
4,813 |
|
Purchase obligations |
|
|
7,629 |
|
|
|
2,543 |
|
|
|
5,086 |
|
|
|
|
|
|
|
|
|
Royalty and consulting agreements |
|
|
4,396 |
|
|
|
815 |
|
|
|
1,146 |
|
|
|
1,091 |
|
|
|
1,344 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations |
|
$ |
265,294 |
|
|
$ |
19,121 |
|
|
$ |
26,957 |
|
|
$ |
12,612 |
|
|
$ |
206,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Payments include amounts representing interest. |
|
(2) |
|
Represents long-term debt payment provided holders of the Convertible Senior
Notes due 2014 do not exercise the option to convert each $1,000 note into 30.6279
shares of our common stock. Our convertible senior notes are discussed further in
Note 9 to our consolidated financial statements contained in Financial Statements
and Supplementary Data. |
|
(3) |
|
Represents interest on Convertible Senior Notes due 2014 payable semiannually
with an annual interest rate of 2.625%. |
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, 2008. The minimum lease payments related to these leases are discussed further in Note
9 to our consolidated financial statements contained in Financial Statements and Supplementary
Data.
The amounts reflected in the table above for operating leases represent future minimum lease
payments under non-cancelable 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, 2008. 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 17 to our consolidated financial statements contained in Financial Statements
and Supplementary Data.
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 under non-cancelable contracts with 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,
2008. These future payments are subject to foreign currency exchange rate risk. Our purchase
obligations and royalty and consulting agreements are disclosed in
Note 17 to our consolidated financial statements contained in Financial Statements and
Supplementary Data.
Our contingent consideration obligations reflected in the table above consist of minimum guaranteed
payments related to our Inbone acquisition. Additionally, cash payments of up to $15 million may be
made
42
related to this and certain other of our acquisitions based upon future financial and
operational performance of the acquired assets.
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. A substantial
portion of our global sales are subject to other royalties earned based on product sales.
Additionally, as of December 31, 2008, we had $1.8 million of unrecognized tax benefits recorded
within Other liabilities on our consolidated balance sheet. This represents the tax benefits
associated with various tax positions taken, or expected to be taken, on domestic and international
tax returns that have not been recognized in our financial statements due to uncertainty regarding
their resolution. We are unable to make a reliable estimate of the eventual cash flows by period
that may be required to settle these matters. In addition, certain of these matters may not require
cash settlement due to the existence of net operating loss carryforwards. Therefore, our
unrecognized tax benefits are not included in the table above. See Note 11 to our consolidated
financial statements contained in Financial Statements and Supplementary Data.
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 2007, we issued $200 million of Convertible Senior Notes due 2014, which generated net
proceeds totaling $193.5 million.
Although it is difficult for us to predict our future liquidity requirements, we believe that our
current cash balance of approximately $87.9 million, our marketable securities balance of $57.6
million and our existing available credit line of $100.0 million will be sufficient for the
foreseeable future to fund our working capital requirements and operations, permit anticipated
capital expenditures in 2009 of approximately $45 million and meet our contractual cash obligations
in 2009.
Critical Accounting Estimates
All of our significant accounting policies and estimates are described in Note 2 to our
consolidated financial statements contained in Financial Statements and Supplementary Data.
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 primarily generated through two types of customers, hospitals
and surgery centers, and stocking distributors, with the majority of our revenue derived from sales
to hospitals. Our products are sold through a network of employee and independent sales
representatives in the U.S. and by a combination of employee sales representatives, independent
sales representatives and stocking distributors
43
outside the U.S. We record revenues from sales to
hospitals and surgery centers when they take title to the product, which is generally when the
product is surgically implanted in a patient.
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. Approximately $172,000 and $252,000 of sales related to these
types of agreements were deferred and not yet recognized as revenue as of December 31, 2008 and
2007, 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 $490,000 and $560,000 are included as a reduction
of accounts receivable at December 31, 2008 and 2007, respectively. Should actual future returns
vary significantly from our historical averages, our operating results could be affected.
Allowances for doubtful accounts. We experience credit losses 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 our accounts receivable are from hospitals, many of which are government funded.
Accordingly, our collection history with this class of customer has been favorable. Historically,
we have experienced minimal bad debts from our hospital customers and more significant bad debts
from certain international stocking distributors, typically as a result of specific financial
difficulty or geo-political factors. We write off accounts receivable when we determine that the
accounts receivable are uncollectible, typically upon customer bankruptcy or the customers
non-response to continuous 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 not 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 was $102.0 million and $83.8 million, net of allowances
for doubtful accounts of $4.0 million and $5.2 million, at December 31, 2008 and 2007,
respectively.
Excess and obsolete inventories. We value our inventory at the lower of the actual cost to purchase
and/or manufacture the inventory on a first-in, first-out (FIFO) basis 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 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
44
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 $8.7 million, $6.6 million and $6.5 million
for the years ended December 31, 2008, 2007 and 2006, respectively. Additionally, in 2007, we
recorded charges of $2.1 million associated with the closure of our manufacturing facility in
Toulon, France, for inventory write-offs and manufacturing costs incurred during a period of
abnormal production capacity.
Goodwill and long-lived assets. We have approximately $49.7 million of goodwill recorded as a
result of the 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 evaluating goodwill for impairment.
The annual evaluation of goodwill impairment may require the use of estimates and assumptions to
determine the fair value of our reporting unit using projections of future cash flows. We performed
our annual impairment test during the fourth quarter of 2008 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 with the
Statement of Financial Accounting Standard (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 and amortization is
adjusted accordingly. Alternatively, should we determine that an asset has been impaired, an
adjustment would be charged to income based on the assets fair market value, or discounted cash
flows if the fair market value is not readily determinable, reducing income in that period.
In 2007, we recognized an impairment charge of $3.2 million for our property, plant and equipment
at our Toulon, France facilities. This impairment charge consisted of the write-down of assets held
for sale to their estimated selling price less costs to sell, as well as the abandonment of the
remaining assets that are no longer in use.
Product liability claims and other litigation. 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. Our accrual for product liability claims was approximately
$310,000 and $610,000 at December 31, 2008 and 2007, respectively.
We are also involved in legal proceedings involving contract, patent protection and other matters.
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 can be developed.
45
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.
Our valuation allowance balances totaled $18.5 million and $6.0 million as of December 31, 2008 and
2007, 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 carryforward of certain tax basis net operating losses and general
business tax credits. During the year ended December 31, 2008, we recognized a tax provision of
$12.8 million to adjust our valuation allowance, primarily to record a valuation allowance against
all of our remaining deferred tax assets associated with net operating losses in France.
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes (FIN 48), effective January 1, 2007, which requires that the tax effects of an income tax
position to be recognized only if it is more-likely-than-not to be sustained based solely on the
technical merits as of the reporting date. As a multinational corporation, we are subject to
taxation in many jurisdictions and the calculation of our tax liabilities involves dealing with
uncertainties in the application of complex tax laws and regulations in various taxing
jurisdictions. If we ultimately determine that the payment of these liabilities will be
unnecessary, we will reverse the liability and recognize a tax benefit in the period in which we
determine the liability no longer applies. Conversely, we record additional tax charges in a period
in which we determine that a recorded tax liability is less than we expect the ultimate assessment
to be. Our liability for unrecognized tax benefits totaled $1.8 million and $6.2 million as of
December 31, 2008 and 2007, respectively. See Note 11 to our consolidated financial statements
contained in Financial Statements and Supplementary Data for further discussion of our
unrecognized tax benefits.
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 establishing tax expense, liabilities and reserves.
We believe adequate provisions exist for income taxes for all periods and jurisdictions subject to
review or audit.
Stock-Based Compensation. We calculate the grant date fair value of non-vested shares as the
closing sales price on the trading day immediately prior to the grant date. We use the
Black-Scholes option pricing model to determine the fair value of stock options and employee stock
purchase plan shares. The determination of the fair value of these stock-based payment awards on
the date of grant using an option-pricing model is affected by our stock price as well as
assumptions regarding a number of complex and subjective variables, which include the expected life
of the award, the expected stock price volatility over the expected life of the awards, expected
dividend yield and risk-free interest rate.
We estimate the expected life of options by calculating the average of the vesting period and the
contractual term of the option, as allowed by SEC Staff Accounting Bulletin No. 107. We estimate
the expected stock price volatility based upon historical volatility of our common stock. The
risk-free interest rate is determined using U.S. Treasury rates where the term is consistent with
the expected life of the stock options. Expected dividend yield is not considered as we have never
paid dividends and have no plans of doing so in the future.
The Black-Scholes option-pricing model was developed for use in estimating the fair value of traded
options that have no vesting restrictions and are fully transferable, characteristics not present
in our option grants and
46
employee stock purchase plan shares. Existing valuation models, including
the Black-Scholes and lattice binomial models, may not provide reliable measures of the fair values
of our stock-based compensation. Consequently, there is a risk that our estimates of the fair
values of our stock-based compensation awards on the grant dates may bear little resemblance to the
actual values realized upon the exercise, expiration, early termination or forfeiture of those
stock-based payments in the future. Certain stock-based payments, such as employee stock options,
may expire worthless or otherwise result in zero intrinsic value as compared to the fair values
originally estimated on the grant date and reported in our financial statements. Alternatively,
value may be realized from these instruments that is significantly higher than the fair values
originally estimated on the grant date and reported in our financial statements. There is not
currently a market-based mechanism or other practical application to verify the reliability and
accuracy of the estimates stemming from these valuation models.
We are required to estimate forfeitures at the time of grant and revise those estimates in
subsequent periods if actual forfeitures differ from those estimates. We use historical data to
estimate pre-vesting forfeitures and record stock-based compensation expense only for those awards
that are expected to vest. All stock-based awards are amortized on a straight-line basis over their
respective requisite service periods, which are generally the vesting periods.
If factors change and we employ different assumptions for estimating stock-based compensation
expense in future periods, the future periods may differ significantly from what we have recorded
in the current period and could materially affect our operating income, net income and net income
per share. It may also result in a lack of comparability with other companies that use different
models, methods and assumptions.
See Note 14 to our consolidated financial statements contained in Financial Statements and
Supplementary Data for further information regarding our stock-based compensation disclosures.
Purchase Accounting. We account for acquired businesses using the purchase method of accounting
which requires that the assets acquired and liabilities assumed be recorded at the date of
acquisition at their respective fair values. Our consolidated financial statements and results of
operations reflect an acquired business after the completion of the acquisition. The cost to
acquire a business, including transaction costs, is allocated to the underlying net assets of the
acquired business in proportion to their respective fair values. Any excess of the purchase price
over the estimated fair values of the net assets acquired is recorded as goodwill.
The amount of the purchase price allocated to intangible assets is determined by estimating the
future cash flows associated with the asset and discounting the net cash flows back to their
present values. The discount rate used is determined at the time of the acquisition in accordance
with standard valuation methods. The estimates of future cash flows include forecasted revenues,
which are inherently difficult to predict. Significant judgments and assumptions are required in
the forecast of future operating results used in the preparation of the estimated future cash
flows, including profit margins, long-term forecasts of the amounts and timing of overall market
growth and our percentage of that market, discount rates and terminal growth rates.
Effective January 1, 2009, we adopted the provisions of SFAS No. 141R, Business Combinations (SFAS
141R), which significantly changes the accounting for acquired businesses. More assets and
liabilities will be measured at their acquisition date fair values. Legal fees and other transaction-related costs
will be expensed as incurred and are no longer included in goodwill as a cost of acquiring the
business. SFAS 141R also requires, among other things, acquirers to estimate the acquisition-date
fair value of any contingent consideration and to recognize any subsequent changes in the fair
value of contingent consideration in earnings. In addition, restructuring costs the acquirer
expected, but was not obligated to incur, will be recognized separately from the business
acquisition.
Restructuring Charges. We evaluate impairment issues for long-lived assets under the provisions of
SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets. We record
severance-related
47
expenses once they are both probable and estimable in accordance with the
provisions of SFAS No. 112, Employers Accounting for Post-Employment Benefits, for severance
provided under an ongoing benefit arrangement. One-time termination benefit arrangements and other
costs associated with exit activities are accounted for under the provisions of SFAS No. 146,
Accounting for Costs Associated with Exit or Disposal Activities. We have estimated the expense for
our restructuring initiative by accumulating detailed estimates of costs, including the estimated
costs of employee severance and related termination benefits, impairment of property, plant and
equipment, contract termination payments for leases and any other qualifying exit costs. Such costs
represent managements best estimates, which are evaluated periodically to determine if an
adjustment is required.
Impact of Recently Issued Accounting Pronouncements
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging
Activities (SFAS 161). SFAS 161 is intended to improve financial reporting about derivative
instruments and hedging activities by requiring enhanced disclosures regarding how an entity uses
derivative instruments, how the derivative instruments and related hedge items are accounted for
under SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities (SFAS 133), as
amended, and how the derivatives affect an entitys financial position, financial performance, and
cash flows. The provisions of SFAS 161 are effective for the year ending December 31, 2009. We are
currently evaluating the impact of the provisions of SFAS 161.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS 162). This standard identifies a consistent framework, or hierarchy, for selecting
accounting principles to be used in preparing financial statements that are presented in conformity
with U.S. generally accepted accounting principles for non-governmental entities. SFAS 162 is
effective 60 days following the SECs approval of the Public Company Accounting Oversight Board
amendments to AU Section 411, The Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principles. The adoption of SFAS 162 is not expected to have a material impact on our
consolidated financial position, results of operations, or cash flows.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, and in February 2008, the
FASB amended SFAS No. 157 by issuing FASB Staff Position FAS 157-1, Application of FASB Statement
No. 157 to FASB Statement No. 13 and Other Accounting Pronouncements That Address Fair Value
Measurements for Purposes of Lease Classification or Measurement under Statement 13, and FASB Staff
Position FAS 157-2, Effective Date of FASB Statement No. 157 (collectively, SFAS 157). SFAS 157
defines fair value, establishes a framework for measuring fair value and expands disclosure of fair
value measurements. SFAS 157 applies under other accounting pronouncements that require or permit
fair value measurements, except those relating to lease classification, and accordingly does not
require any new fair value measurements. SFAS 157 is effective for financial assets and liabilities
in fiscal years beginning after November 15, 2007, and for non-financial assets and liabilities in
fiscal years beginning after November 15, 2008. We adopted SFAS 157 for financial assets and
liabilities in the first quarter of fiscal 2008 with no material impact to our consolidated
financial statements. We are currently evaluating the impact the application of SFAS 157 will have
on our consolidated financial statements as it relates to our non-financial assets and liabilities.
In December 2007, the FASB issued SFAS No. 141 (Revised 2007), Business Combinations (SFAS 141R)
and SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements, an Amendment of
ARB No. 51 (SFAS 160). SFAS 141R and SFAS 160 significantly change the accounting for and reporting
of business combination transactions and noncontrolling (minority) interests. Under SFAS 141R, an
acquiring entity will be required to recognize all the assets and liabilities assumed in a
transaction at the acquisition date fair value. In addition, SFAS 141R includes a substantial
number of additional disclosure requirements. SFAS 160 changes the accounting and reporting for
minority interests, which will be recharacterized as
48
noncontrolling interests and classified as a
component of equity. We will apply the provisions of SFAS 141R and SFAS 160 prospectively effective
January 1, 2009.
49
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
Our exposure to interest rate risk arises principally from the interest rates associated with our
invested cash balances. On December 31, 2008, we had short term cash investments and marketable
securities totaling approximately $112 million. Based on this level of investment, a decrease of
0.25% in interest rates would have a negative annual impact of $281,000 to our interest income. 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 28% of our total net sales were denominated in foreign
currencies during each of the years ended December 31, 2008 and 2007, and we expect that foreign
currencies will continue to represent a similarly significant percentage of our net sales in the
future. Cost of sales related to these sales are primarily denominated in U.S. dollars; however,
operating costs related to these sales are largely denominated in the same respective currencies,
thereby partially 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 EU
countries, which are denominated in the euro, from Japan, which are denominated in the Japanese yen
and from the United Kingdom, which are denominated in the British pound. Additionally, we have
significant intercompany receivables from our foreign subsidiaries which are denominated in foreign
currencies, principally the euro, the yen and the British pound. Our principal exchange rate risk,
therefore, exists between the U.S. dollar and the euro, the U.S. dollar and the yen and the U.S.
dollar and the British pound. 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 Financial Statements and
Supplementary Data, 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.
50
Item 8. Financial Statements and Supplementary Data.
Wright Medical Group, Inc.
Consolidated Financial Statements
for the Years Ended December 31, 2008, 2007 and 2006
Index to Financial Statements
51
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 (the Company) as of December 31, 2008 and 2007, 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, 2008. 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 the Company as of December 31, 2008 and 2007, and the
results of their operations and their cash flows for each of the years in the three-year period
ended December 31, 2008, in conformity with U.S. generally accepted accounting principles.
As discussed in Notes 2 and 11 to the consolidated financial statements, effective January 1, 2007,
the Company changed its method of accounting for uncertainty in income taxes as required by FASB
Interpretation No. 48, Accounting for Uncertainty in Income Taxes. Also as discussed in Note 2 to
the consolidated financial statements, the Company changed its method of quantifying errors in
2006.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the Companys internal control over financial reporting as of December 31,
2008, 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 23, 2009 expressed an unqualified opinion on the effectiveness of the Companys internal
control over financial reporting.
(signed) KPMG LLP
Memphis, Tennessee
February 23, 2009
52
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Wright Medical Group, Inc.:
We have audited the effectiveness of internal control over financial reporting of Wright Medical
Group, Inc. and subsidiaries (the Company) as of December 31, 2008, 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 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, assessing the risk that a material weakness exists, and testing
and evaluating the design and operating effectiveness of internal control based on the assessed
risk. Our audit also included 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 U.S. 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 U.S. 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, the Company maintained, in all material respects, effective internal
control over financial reporting as of December 31, 2008, 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 the Company as of
December 31, 2008 and 2007, 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, 2008, and
our report dated
53
February 23, 2009 expressed an unqualified opinion on those consolidated
financial statements.
(signed) KPMG LLP
Memphis, Tennessee
February 23, 2009
54
Wright Medical Group, Inc.
Consolidated Balance Sheets
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Assets: |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
87,865 |
|
|
$ |
229,026 |
|
Marketable securities |
|
|
57,614 |
|
|
|
15,535 |
|
Accounts receivable, net |
|
|
102,046 |
|
|
|
83,801 |
|
Inventories |
|
|
176,059 |
|
|
|
115,290 |
|
Prepaid expenses |
|
|
14,263 |
|
|
|
13,757 |
|
Deferred income taxes |
|
|
29,874 |
|
|
|
24,015 |
|
Assets held for sale |
|
|
|
|
|
|
2,207 |
|
Other current assets |
|
|
8,934 |
|
|
|
7,570 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
476,655 |
|
|
|
491,201 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
133,651 |
|
|
|
99,037 |
|
Goodwill |
|
|
49,682 |
|
|
|
28,233 |
|
Intangible assets, net |
|
|
21,090 |
|
|
|
11,187 |
|
Deferred income taxes |
|
|
3,034 |
|
|
|
30,556 |
|
Other assets |
|
|
8,018 |
|
|
|
9,771 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
692,130 |
|
|
$ |
669,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity: |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
15,877 |
|
|
$ |
19,764 |
|
Accrued expenses and other current liabilities |
|
|
59,247 |
|
|
|
53,069 |
|
Current portion of long-term obligations |
|
|
125 |
|
|
|
551 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
75,249 |
|
|
|
73,384 |
|
Long-term debt and capital lease obligations |
|
|
200,136 |
|
|
|
200,455 |
|
Deferred income taxes |
|
|
166 |
|
|
|
159 |
|
Other liabilities |
|
|
4,951 |
|
|
|
7,206 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
280,502 |
|
|
|
281,204 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Note 17) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Common stock, voting, $.01 par value, shares
authorized 100,000,000; shares issued and
outstanding 38,021,961 in 2008 and 36,493,183 in 2007 |
|
|
372 |
|
|
|
365 |
|
Additional paid-in capital |
|
|
364,594 |
|
|
|
338,640 |
|
Accumulated other comprehensive income |
|
|
18,312 |
|
|
|
24,623 |
|
Retained earnings |
|
|
28,350 |
|
|
|
25,153 |
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
411,628 |
|
|
|
388,781 |
|
|
|
|
|
|
|
|
|
|
$ |
692,130 |
|
|
$ |
669,985 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
55
Wright Medical Group, Inc.
Consolidated Statements of Operations
(In thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Net sales |
|
$ |
465,547 |
|
|
$ |
386,850 |
|
|
$ |
338,938 |
|
Cost of sales1 |
|
|
134,377 |
|
|
|
108,407 |
|
|
|
97,234 |
|
Cost of sales restructuring |
|
|
|
|
|
|
2,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
331,170 |
|
|
|
276,304 |
|
|
|
241,704 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative1 |
|
|
261,396 |
|
|
|
225,929 |
|
|
|
192,573 |
|
Research and development 1 |
|
|
33,292 |
|
|
|
28,405 |
|
|
|
25,551 |
|
Amortization of intangible assets |
|
|
4,874 |
|
|
|
3,782 |
|
|
|
4,149 |
|
Restructuring charges (Note 16) |
|
|
6,705 |
|
|
|
16,734 |
|
|
|
|
|
Acquired in-process research and development
costs (Note 3) |
|
|
2,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
308,757 |
|
|
|
274,850 |
|
|
|
222,273 |
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
22,413 |
|
|
|
1,454 |
|
|
|
19,431 |
|
Interest expense (income), net |
|
|
2,181 |
|
|
|
(1,252 |
) |
|
|
(1,127 |
) |
Other (income) expense, net |
|
|
(1,338 |
) |
|
|
375 |
|
|
|
(1,643 |
) |
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
21,570 |
|
|
|
2,331 |
|
|
|
22,201 |
|
Provision for income taxes |
|
|
18,373 |
|
|
|
1,370 |
|
|
|
7,790 |
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
3,197 |
|
|
$ |
961 |
|
|
$ |
14,411 |
|
|
|
|
|
|
|
|
|
|
|
Net income per share (Note 12): |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.09 |
|
|
$ |
0.03 |
|
|
$ |
0.42 |
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.09 |
|
|
$ |
0.03 |
|
|
$ |
0.41 |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of shares outstanding basic |
|
|
36,933 |
|
|
|
35,812 |
|
|
|
34,434 |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of shares outstanding diluted |
|
|
37,401 |
|
|
|
36,483 |
|
|
|
35,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
These line items include the following amounts of
non-cash, stock-based compensation expense for the periods indicated: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2008 |
|
2007 |
|
2006 |
Cost of sales |
|
$ |
1,244 |
|
|
$ |
2,046 |
|
|
$ |
854 |
|
Selling, general and administrative |
|
|
10,644 |
|
|
|
12,061 |
|
|
|
10,766 |
|
Research and development |
|
|
1,613 |
|
|
|
2,425 |
|
|
|
2,220 |
|
The accompanying notes are an integral part of these consolidated financial statements.
56
Wright Medical Group, Inc.
Consolidated Statements of Cash Flows
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
3,197 |
|
|
$ |
961 |
|
|
$ |
14,411 |
|
Adjustments to reconcile net income to net cash
(used in) provided by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
26,462 |
|
|
|
23,522 |
|
|
|
21,361 |
|
Stock-based compensation expense |
|
|
13,501 |
|
|
|
16,532 |
|
|
|
13,840 |
|
Acquired in-process research and development
costs |
|
|
2,490 |
|
|
|
|
|
|
|
|
|
Amortization of intangible assets |
|
|
4,874 |
|
|
|
3,782 |
|
|
|
4,149 |
|
Deferred income taxes |
|
|
18,325 |
|
|
|
(8,708 |
) |
|
|
(8,852 |
) |
Gain on sale of investment |
|
|
|
|
|
|
|
|
|
|
(1,499 |
) |
Excess tax benefits from stock-based
compensation arrangements |
|
|
(1,278 |
) |
|
|
(3,633 |
) |
|
|
(4,908 |
) |
Non-cash restructuring charges |
|
|
(63 |
) |
|
|
5,295 |
|
|
|
|
|
Other |
|
|
1,233 |
|
|
|
111 |
|
|
|
1,340 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(18,729 |
) |
|
|
(9,831 |
) |
|
|
(8,555 |
) |
Inventories |
|
|
(57,797 |
) |
|
|
(27,077 |
) |
|
|
(867 |
) |
Marketable securities |
|
|
15,535 |
|
|
|
14,790 |
|
|
|
(5,325 |
) |
Prepaid expenses and other current assets |
|
|
(6,666 |
) |
|
|
(6,103 |
) |
|
|
4,600 |
|
Accounts payable |
|
|
(5,009 |
) |
|
|
1,889 |
|
|
|
2,504 |
|
Accrued expenses and other liabilities |
|
|
315 |
|
|
|
12,894 |
|
|
|
(2,224 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by operating activities |
|
|
(3,610 |
) |
|
|
24,424 |
|
|
|
29,975 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(61,936 |
) |
|
|
(35,042 |
) |
|
|
(29,643 |
) |
Acquisition of businesses |
|
|
(28,914 |
) |
|
|
(27,758 |
) |
|
|
|
|
Purchase of intangible assets |
|
|
(3,418 |
) |
|
|
(1,041 |
) |
|
|
(705 |
) |
Proceeds from sale of investment |
|
|
|
|
|
|
|
|
|
|
1,499 |
|
Investment in available-for-sale marketable securities |
|
|
(57,037 |
) |
|
|
|
|
|
|
|
|
Other |
|
|
2,363 |
|
|
|
|
|
|
|
500 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(148,942 |
) |
|
|
(63,841 |
) |
|
|
(28,349 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock |
|
|
12,018 |
|
|
|
17,292 |
|
|
|
5,915 |
|
Proceeds from issuance of convertible senior notes |
|
|
|
|
|
|
193,492 |
|
|
|
|
|
Financing under factoring agreements, net |
|
|
(605 |
) |
|
|
(3,457 |
) |
|
|
(54 |
) |
Principal payments of bank and other financing |
|
|
(285 |
) |
|
|
(1,063 |
) |
|
|
(6,123 |
) |
Excess tax benefits from stock-based compensation
arrangements |
|
|
1,278 |
|
|
|
3,633 |
|
|
|
4,908 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
12,406 |
|
|
|
209,897 |
|
|
|
4,646 |
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
(1,015 |
) |
|
|
607 |
|
|
|
390 |
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(141,161 |
) |
|
|
171,087 |
|
|
|
6,662 |
|
Cash and cash equivalents, beginning of period |
|
|
229,026 |
|
|
|
57,939 |
|
|
|
51,277 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
87,865 |
|
|
$ |
229,026 |
|
|
$ |
57,939 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
57
Wright Medical Group, Inc.
Consolidated Statements of Changes in Stockholders Equity and Comprehensive Income
For the Years Ended December 31, 2006, 2007 and 2008
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Common Stock, Voting |
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Number of |
|
|
|
|
|
|
Paid-in |
|
|
Retained |
|
|
Comprehensive |
|
|
Stockholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Earnings |
|
|
Income |
|
|
Equity |
|
|
|
|
|
|
Balance at December 31, 2005 |
|
|
34,175,696 |
|
|
$ |
342 |
|
|
$ |
274,312 |
|
|
$ |
5,397 |
|
|
$ |
11,957 |
|
|
$ |
292,008 |
|
|
|
|
|
|
2006 Activity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,411 |
|
|
|
|
|
|
|
14,411 |
|
Foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,921 |
|
|
|
5,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,332 |
|
SAB 108 adjustment to opening
balance (Note 2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,861 |
) |
|
|
|
|
|
|
(2,861 |
) |
Issuances of common stock |
|
|
968,104 |
|
|
|
9 |
|
|
|
5,906 |
|
|
|
|
|
|
|
|
|
|
|
5,915 |
|
Tax benefit of employee stock
option exercises |
|
|
|
|
|
|
|
|
|
|
5,585 |
|
|
|
|
|
|
|
|
|
|
|
5,585 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
14,845 |
|
|
|
|
|
|
|
|
|
|
|
14,845 |
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
35,143,800 |
|
|
$ |
351 |
|
|
$ |
300,648 |
|
|
$ |
16,947 |
|
|
$ |
17,878 |
|
|
$ |
335,824 |
|
|
|
|
|
|
2007 Activity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
961 |
|
|
|
|
|
|
|
961 |
|
Foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,970 |
|
|
|
6,970 |
|
Minimum pension liability
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(225 |
) |
|
|
(225 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,706 |
|
FIN 48 adjustment to opening
balance (Note 11) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,245 |
|
|
|
|
|
|
|
7,245 |
|
Issuances of common stock |
|
|
1,349,383 |
|
|
|
14 |
|
|
|
17,278 |
|
|
|
|
|
|
|
|
|
|
|
17,292 |
|
Tax benefit of employee stock
option exercises |
|
|
|
|
|
|
|
|
|
|
4,289 |
|
|
|
|
|
|
|
|
|
|
|
4,289 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
16,425 |
|
|
|
|
|
|
|
|
|
|
|
16,425 |
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
36,493,183 |
|
|
$ |
365 |
|
|
$ |
338,640 |
|
|
$ |
25,153 |
|
|
$ |
24,623 |
|
|
$ |
388,781 |
|
|
|
|
|
|
2008 Activity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,197 |
|
|
|
|
|
|
|
3,197 |
|
Foreign currency translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,781 |
) |
|
|
(6,781 |
) |
Unrealized gain on marketable
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
399 |
|
|
|
399 |
|
Minimum pension liability
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71 |
|
|
|
71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,114 |
) |
Issuances of common stock |
|
|
616,836 |
|
|
|
7 |
|
|
|
12,011 |
|
|
|
|
|
|
|
|
|
|
|
12,018 |
|
Issuance of previously granted
restricted stock |
|
|
434,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant of restricted stock |
|
|
558,184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of restricted stock |
|
|
(80,247 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax benefit of employee stock
option exercises |
|
|
|
|
|
|
|
|
|
|
720 |
|
|
|
|
|
|
|
|
|
|
|
720 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
13,223 |
|
|
|
|
|
|
|
|
|
|
|
13,223 |
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
38,021,961 |
|
|
$ |
372 |
|
|
$ |
364,594 |
|
|
$ |
28,350 |
|
|
$ |
18,312 |
|
|
$ |
411,628 |
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
58
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Organization and Description of Business
Wright Medical Group, Inc., through Wright Medical Technology, Inc. and other operating
subsidiaries (Wright), is a global orthopaedic medical device company specializing in the design,
manufacture and marketing of reconstructive joint devices and biologics products. Our products are
sold primarily through a network of employee sales representatives and 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. We promote our
products in over 60 countries with principal markets in the U.S., Europe and Japan. We are
headquartered in Arlington, Tennessee.
2. Summary of Significant Accounting Policies
Principles of Consolidation. The accompanying consolidated financial statements include our
accounts and those of our wholly owned domestic and international subsidiaries. Intercompany
accounts and transactions have been eliminated in consolidation.
Use of Estimates. The preparation of financial statements in conformity with U.S. generally
accepted accounting principles 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 other litigation, income taxes, stock-based compensation, purchase accounting for business
combinations, and accounting for restructuring charges.
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. Our 2007 investment in marketable securities represented debt securities,
which were classified as trading securities in accordance with Statement of Financial Accounting
Standards (SFAS) No. 115, Accounting for Certain Investments in Debt and Equity Securities (SFAS
115). For the years ended December 31, 2007 and 2006, we did not incur any realized or unrealized
gains or losses related to these securities. During the first quarter of 2008, we liquidated all
those investments into cash equivalents. During the remainder of 2008, we invested in treasury
bills, government and agency bonds, and certificates of deposit with maturity dates of less than 12
months and certificates of deposit with maturity dates of six months or less. Our investments in
these marketable securities are classified as available-for-sale securities in accordance with SFAS
115. These securities are carried at their fair value, and all unrealized gains and losses are
recorded within other comprehensive income.
Inventories. Our 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. 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. Charges
incurred for excess and obsolete inventory were $8.7 million, $6.6 million and $6.5 million for the
years ended December 31, 2008, 2007 and 2006, respectively.
Additionally, in 2007, we recorded charges of $2.1 million associated with the closure of our
manufacturing facility in Toulon, France for inventory write-offs and manufacturing costs incurred
during a period of abnormal production capacity, which were expensed as period costs in accordance
with Financial Accounting Standards Board (FASB) Statement No. 151, Inventory Costs, an Amendment
of ARB No. 43, Chapter 4.
59
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
Product Liability Claims and Other Litigation. 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. Our accrual for
product liability claims was $310,000 and $610,000 at December 31, 2008 and 2007, respectively.
Property, Plant and Equipment. Our property, plant and equipment is stated at cost. Depreciation,
which includes amortization of assets under capital lease, is generally provided on a straight-line
basis over the estimated useful lives generally based on the following categories:
|
|
|
|
|
Land improvements |
|
|
15 to 25 years |
|
Buildings |
|
10 to 45 years |
Machinery and equipment |
|
|
3 to 12 years |
|
Furniture, fixtures and office equipment |
|
|
1 to 14 years |
|
Surgical instruments |
|
6 years |
|
Expenditures for major renewals and betterments, including leasehold improvements, that extend the
useful life of the assets are capitalized and depreciated over the remaining life of the asset or
lease term, if shorter. 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 net assets of businesses acquired. Goodwill is required to be tested for
impairment at least annually. Unless circumstances otherwise dictate, the annual impairment test is
performed in the fourth quarter. Accordingly, during the fourth quarter of 2008, we evaluated
goodwill for impairment and determined that the fair value of our reporting unit exceeded its
carrying value, indicating that goodwill was not impaired. Based on our single business approach to
decision-making, planning and resource allocation, management has determined that we have only one
reporting unit for purposes of evaluating goodwill for impairment.
Our 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 SFAS No. 144, Accounting for Impairment or Disposal of Long-Lived
Assets (SFAS 144). The weighted average amortization periods for completed technology, distribution
channels, trademarks, licenses, customer relationships and other are 9 years, 10 years, 7 years, 7
years, 11 years and 5 years, respectively. The weighted average amortization period of our
intangible assets on a combined basis is 9 years. Additionally, we have one trademark intangible
asset that has an indefinite life.
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. We account for the impairment of
long-lived assets in accordance SFAS 144. Accordingly, we evaluate impairment of our 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 and
amortization is adjusted accordingly. Alternatively, should we determine that an asset is impaired,
an adjustment would be charged to income based on the assets fair market value or discounted cash
flows if the fair market value is not readily determinable, reducing income in that period.
In 2007, we recognized an impairment charge of $3.2 million for our property, plant and equipment
at our Toulon, France facilities. This impairment charge consisted of the write-down of assets held
for sale to their estimated selling price less costs to sell, as well as the abandonment of the
remaining assets that are no longer in use. See Note 16 for further discussion of our restructuring
charges.
60
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
Allowances for Doubtful Accounts. We experience credit losses on our accounts receivable and,
accordingly, we must make estimates related to the ultimate collection of our accounts receivable.
Specifically, management analyzes our accounts receivable, historical bad debt experience, customer
concentrations, customer credit-worthiness and current economic trends when evaluating the adequacy
of our allowance for doubtful accounts.
The majority of our accounts receivable are from hospitals, many of which are government funded.
Accordingly, our collection history with this class of customer has been favorable. Historically,
we have experienced minimal bad debts from our hospital customers and more significant bad debts
from certain international stocking distributors, typically as a result of specific financial
difficulty or geo-political factors. We write off accounts receivable when we determine that the
accounts receivable are uncollectible, typically upon customer bankruptcy or the customers
non-response to continued collection efforts. Our allowance for doubtful accounts totaled $4.0
million and $5.2 million at December 31, 2008 and 2007, respectively.
Concentration of Credit Risk. Financial instruments which potentially subject us to concentrations
of credit risk consist principally of accounts receivable. Management attempts to minimize credit
risk by reviewing customers credit history before extending credit and by monitoring credit
exposure on a regular basis. An allowance for possible losses on accounts receivable is established
based upon factors surrounding the credit risk of specific customers, historical trends and other
information. Collateral or other security is generally not required for accounts receivable. As of
December 31, 2008, one customer, our stocking distributor in Turkey, accounted for more than 10% of
our accounts receivable balance. As of December 31, 2008 and 2007, the balance due from this
customer was $10.6 million or 10.4% of our accounts receivable balance, and $8.0 million or 9.5% of
our accounts receivable balance, respectively. There were no customers that accounted for more than
10% of accounts receivable as of December 31, 2007.
Concentrations of Supply of Raw Material. 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, stainless steel, various grades of high density
polyethylenes, and ceramics. We rely on one source to supply us with a certain grade of cobalt
chrome alloy and one supplier for the silicone elastomer used in some of 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. For
certain biologics products, we depend on one supplier of demineralized bone matrix (DBM) and
cancellous bone matrix (CBM). We rely on one supplier for our GRAFTJACKET® family of
soft tissue repair and graft containment products, and one supplier for our xenograph bone wedge
product. We maintain adequate stock from these suppliers in order to meet market demand.
Income Taxes. Income taxes are accounted for pursuant to the provisions of SFAS No. 109, Accounting
for Income Taxes, and FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes An
Interpretation of FASB Statement No. 109 (FIN 48). 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 financial accounting purposes.
These differences result in deferred tax assets and liabilities, which are included within our
consolidated balance sheet. The measurement of deferred tax assets is reduced by a valuation
allowance if, based upon available evidence, it is more likely than not that some or all of the
deferred tax assets will not be realized.
We provide for unrecognized tax benefits based upon our assessment of whether a tax position is
more-likely-than-not to be sustained upon examination by the tax authorities. If a tax position
meets the more-likely-than-not standard, then the related tax benefit is measured based on a
cumulative probability analysis of the amount that is more-likely-than-not to be realized upon
ultimate settlement or disposition of the underlying tax position.
61
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
Other Taxes. Taxes assessed by a governmental authority that are imposed concurrent with our
revenue transactions with customers are presented on a net basis in our consolidated statement of
operations.
Revenue Recognition. Our revenues are primarily generated through two types of customers, hospitals
and surgery centers, and stocking distributors, with the majority of our revenue derived from sales
to hospitals. Our products are primarily sold through a network of employee sales representatives
and 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 generally when the product is surgically implanted in a patient.
We record revenues from sales to our 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. Our 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 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. Approximately $172,000 and $252,000 of deferred revenue
related to these types of agreements was recorded at December 31, 2008 and 2007, respectively.
We must make estimates of potential future product returns related to current period product
revenue. We develop 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 $490,000 and $560,000 is
included as a reduction of accounts receivable at December 31, 2008 and 2007, respectively.
Shipping and Handling Costs. We incur shipping and handling costs associated with the shipment of
goods to customers, independent distributors and our 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 our 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 on our
consolidated statement of operations.
Pension Benefits. Our subsidiary in Japan provides benefits to employees under a plan that we
account for as a defined benefit plan in accordance with SFAS No. 87, Employers Accounting for
Pensions, and SFAS No. 158, Employers Accounting for Defined Benefit Pension and Other
Postretirement Plansan amendment of FASB Statements No. 87, 88, 106, and 132(R). This plan is
unfunded, and determining the minimum pension liability requires the use of assumptions and
estimates, including discount rates and mortality rates, and actuarial methods. Our minimum pension
liability totaled $1.4 million and $970,000 as of December 31, 2008 and 2007, respectively.
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 our
62
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
net income and our comprehensive income is attributable to foreign currency translation,
adjustments to our minimum pension liability, and unrealized gains and losses on our
available-for-sale securities.
Stock-Based Compensation. We account for stock-based compensation in accordance with SFAS No. 123
(Revised 2004), Share-Based Payment (SFAS 123R). Under the fair value recognition provisions of
SFAS 123R, stock-based compensation cost is measured at the grant date based on the fair value of
the award and is recognized as expense on a straight-line basis over the requisite service period,
which is the vesting period. The determination of the fair value of stock-based payment awards,
such as options, on the date of grant using an option-pricing model is affected by our stock price,
as well as assumptions regarding a number of complex and subjective variables, which include the
expected life of the award, the expected stock price volatility over the expected life of the
awards, expected dividend yield and risk-free interest rate.
We recorded $13.5 million, $16.5 million and $13.8 million of stock-based compensation expense
during the years ended December 31, 2008, 2007 and 2006, respectively. See Note 14 for further
information regarding our stock-based compensation assumptions and expenses.
Fair Value of Financial Instruments. The carrying value of cash and cash equivalents, marketable
securities, accounts receivable and accounts payable approximates the fair value of these financial
instruments at December 31, 2008 and 2007 due to their short maturities or variable rates.
The fair value of our convertible senior notes was approximately $155 million and $216 million as
of December 31, 2008 and 2007, respectively.
Effective January 1, 2008, we adopted the provisions of SFAS No. 157, Fair Value Measurements (SFAS
157), for financial assets and liabilities measured at fair value on a recurring basis. SFAS 157
applies to all financial assets and liabilities that are being measured and reported on a fair
value basis, and establishes a framework for measuring the fair value of assets and liabilities and
expands disclosures about fair value measurements. The adoption of SFAS 157 had no impact to our
consolidated financial statements. SFAS 157 requires fair value measurements be classified and
disclosed in one of the following three categories:
|
|
|
Level 1:
|
|
Financial instruments with unadjusted, quoted prices listed on
active market exchanges. |
|
|
|
Level 2:
|
|
Financial instruments determined using prices for recently traded
financial instruments with similar underlying terms as well as
directly or indirectly observable inputs, such as interest rates
and yield curves that are observable at commonly quoted
intervals. |
|
|
|
Level 3:
|
|
Financial instruments that are not actively traded on a market
exchange. This category includes situations where there is
little, if any, market activity for the financial instrument. The
prices are determined using significant unobservable inputs or
valuation techniques. |
As of December 31, 2008, we have available-for-sale marketable securities totaling $57.6 million,
consisting of investments in treasury bills, government and agency bonds and certificates of
deposits, all of which are valued at fair value using a market approach. A total of $56.5 million
of our available-for-sale securities is valued based on quoted prices in active exchange markets
(Level 1). The remaining $1.2 million is valued at fair value using other observable inputs (Level
2).
Derivative Instruments. We account for derivative instruments and hedging activities under SFAS No.
133, Accounting for Derivative Instruments and Hedging Activities (SFAS 133), as amended.
Accordingly, all of our derivative instruments are recorded in the accompanying consolidated
balance sheet as either an asset or liability and
63
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
measured at fair value. The changes in the derivatives fair value are recognized currently in
earnings unless specific hedge accounting criteria are met.
We 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. Accordingly, the changes in the fair value and the settlement of
the contracts are recognized in the period incurred in the accompanying consolidated statements of
operations.
We recorded net losses of $1.5 million, $2.8 million and $1.9 million, for the years ended December
31, 2008, 2007 and 2006, respectively, on foreign currency contracts, which are included in Other
(income) expense, net in our consolidated statements of operations. These losses substantially
offset translation gains recorded on our intercompany receivable and payable balances, also
included in Other (income) expense, net. At December 31, 2008 and 2007, we had no foreign
currency contracts outstanding.
Supplemental Cash Flow Information. Cash paid for interest and income taxes was as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Interest |
|
$ |
5,963 |
|
|
$ |
1,898 |
|
|
$ |
1,298 |
|
Income taxes |
|
$ |
4,960 |
|
|
$ |
10,408 |
|
|
$ |
9,663 |
|
During 2008, we sold certain assets of our Toulon, France facility. As part of that sale, the buyer
assumed our capital lease obligations of approximately $700,000 for certain machinery and equipment
located in that facility. During 2006, we favorably resolved certain income tax contingencies
associated with a prior acquisition, resulting in a decrease in goodwill of $140,000. We entered
into insignificant amounts of capital leases during 2006, 2007 and 2008.
Adoption of SAB 108. In September 2006, the U.S. Securities and Exchange Commission (SEC) issued
Staff Accounting Bulletin No. 108, Considering the Effects of Prior Year Misstatements when
Quantifying Misstatements in Current Year Financial Statements (SAB 108), to address diversity in
practice in quantifying financial statement misstatements. SAB 108 requires registrants to consider
both the rollover method which focuses on the income statement impact of misstatements and the
iron curtain method which focuses on the balance sheet impact of misstatements to define
materiality. The transition provisions of SAB 108 allow a registrant to adjust opening retained
earnings for the cumulative effect of immaterial errors relating to prior years. We adopted SAB 108
during the year ended December 31, 2006.
64
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
During 2006, we concluded there was an error in our method of calculating depreciation expense for
our surgical instruments, resulting in an understatement of depreciation expense for the years 2000
through 2005. Under SAB 108, we assessed materiality of errors originating in prior years using
both the rollover method and the iron-curtain method. Management concluded that the impact of this
error was immaterial for each of the prior years under the rollover method, which was the method we
used prior to the adoption of SAB 108. However, under the iron-curtain method, the cumulative
effect of the balance sheet adjustment was material to our 2006 statement of operations. Therefore,
an adjustment was recorded to 2006 opening retained earnings in accordance with the implementation
guidance in SAB 108. The total cumulative impact was as follows (in thousands):
|
|
|
|
|
|
|
Increase/ |
|
|
|
(Decrease) |
|
Accumulated depreciation |
|
$ |
4,721 |
|
Deferred tax asset |
|
|
1,860 |
|
Retained earnings |
|
|
(2,861 |
) |
Recently Issued Accounting Pronouncements. In March 2008, the FASB issued SFAS No. 161, Disclosures
about Derivative Instruments and Hedging Activities (SFAS 161). SFAS 161 is intended to improve
financial reporting about derivative instruments and hedging activities by requiring enhanced
disclosures regarding how an entity uses derivative instruments, how the derivative instruments and
related hedge items are accounted for under SFAS No. 133, as amended, and how the derivatives
affect an entitys financial position, financial performance and cash flows. The provisions of SFAS
161 are effective for the year ending December 31, 2009. We are currently evaluating the impact of
the provisions of SFAS 161.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS 162). This standard identifies a consistent framework, or hierarchy, for selecting
accounting principles to be used in preparing financial statements that are presented in conformity
with U.S. generally accepted accounting principles for nongovernmental entities. SFAS 162 is
effective 60 days following the SECs approval of the Public Company Accounting Oversight Board
amendments to Audit Standard (AU) Section 411, The Meaning of Present Fairly in Conformity with
Generally Accepted Accounting Principles. The adoption of SFAS 162 is not expected to have a
material impact on our consolidated financial position, results of operations or cash flows.
In September 2006, the FASB issued SFAS 157 and in February 2008, the FASB amended SFAS 157 by
issuing FASB Staff Position FAS 157-1, Application of FASB Statement No. 157 to FASB Statement No.
13 and Other Accounting Pronouncements That Address Fair Value Measurements for Purposes of Lease
Classification or Measurement under Statement 13, and FASB Staff Position FAS 157-2, Effective Date
of FASB Statement No. 157 (collectively, SFAS 157). SFAS 157 defines fair value, establishes a
framework for measuring fair value and expands disclosure of fair value measurements. SFAS 157
applies under other accounting pronouncements that require or permit fair value measurements,
except those relating to lease classification, and accordingly does not require any new fair value
measurements. SFAS 157 is effective for financial assets and liabilities in fiscal years beginning
after November 15, 2007, and for non-financial assets and liabilities in fiscal years beginning
after November 15, 2008. We adopted SFAS 157 for financial assets and liabilities in the first
quarter of fiscal 2008 with no material impact to our consolidated financial statements. We are
currently evaluating the impact the application of SFAS 157 will have on our consolidated financial
statements as it relates to our non-financial assets and liabilities.
In December 2007, the FASB issued SFAS No. 141 (Revised 2007), Business Combinations (SFAS 141R)
and SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements, an Amendment of
ARB No. 51 (SFAS 160). SFAS 141R and SFAS 160 significantly change the accounting for and reporting
of business combination transactions and noncontrolling (minority) interests. Under SFAS 141R, an
acquiring entity will be required to recognize all the assets and liabilities assumed in a
transaction at the acquisition date fair value. In addition, SFAS 141R includes a substantial
number of additional disclosure requirements. SFAS 160 changes the accounting and reporting for minority interests, which will be recharacterized as noncontrolling
interests and
65
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
classified as a component of equity. We will apply the provisions of SFAS 141R and
SFAS 160 prospectively effective January 1, 2009.
3. Acquisitions
INBONE Technologies, Inc. On April 3, 2008, we completed the acquisition of Inbone Technologies,
Inc. (Inbone), a privately held company focused on the field of ankle arthroplasty and small bone
fusion. The purchase consisted of an initial cash payment of $23.2 million, guaranteed future
minimum payments of $3.7 million and potential additional cash payments based upon future
operational and financial performance of the company. Assets acquired include the
INBONE Total Ankle System and the INBONE Intra-osseous Fusion Rod and Plate
System.
The operating results from this acquisition are included in the consolidated financial statements
from the acquisition date.
The acquisition was recorded by allocating the costs of the assets acquired based on their
estimated fair values at the acquisition date. The excess of the cost of the acquisition over the
net of amounts assigned to the fair value of the assets acquired is recorded as goodwill. The
following is a summary of the estimated fair values of the net assets acquired, which includes
transaction costs and the guaranteed future minimum payments (in thousands):
|
|
|
|
|
Cash |
|
$ |
745 |
|
Accounts receivable |
|
|
708 |
|
Inventories |
|
|
1,047 |
|
Deferred income tax assets |
|
|
384 |
|
Property, plant and equipment |
|
|
810 |
|
Other assets |
|
|
159 |
|
In-process research and development |
|
|
2,490 |
|
Intangible assets |
|
|
9,480 |
|
Goodwill |
|
|
19,081 |
|
|
|
|
|
Total assets |
|
$ |
34,904 |
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
1,814 |
|
Deferred income tax liabilities |
|
|
3,739 |
|
Debt assumed |
|
|
1,727 |
|
|
|
|
|
Total liabilities |
|
$ |
7,280 |
|
|
|
|
|
|
|
|
|
|
Net assets acquired |
|
$ |
27,624 |
|
Less cash acquired |
|
|
(745 |
) |
Plus debt assumed and paid at closing |
|
|
1,727 |
|
|
|
|
|
Total purchase price |
|
$ |
28,606 |
|
|
|
|
|
Of the $9.5 million of acquired intangible assets, $5.2 million was assigned to completed
technology (ten year useful life), $1.5 million was assigned to registered trademarks (indefinite
useful life), $1.4 million was assigned to customer relationships (twelve year useful life), and
$1.4 million was assigned to other assets (five year useful life).
As part of the purchase price allocation, we recorded accrued expenses of $561,000 to involuntarily
terminate or relocate employees of the acquired entity. These exit activities were completed during
the second quarter of 2008.
In connection with this acquisition, we immediately recognized as expense approximately $2.5
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. The value assigned to IPRD was
determined by
66
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
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 using an 18% risk adjusted discount rate. This discount rate reflected
uncertainties surrounding the successful development of IPRD.
A.M. Surgical, Inc. On June 9, 2008, we acquired certain assets of A.M. Surgical, Inc. (A.M.
Surgical), a New York-based company focused on providing endoscopic soft tissue release products
for foot and ankle surgeons. Prior to the acquisition, we had marketed A.M. Surgicals foot and
ankle products pursuant to a distribution agreement signed in October 2007. The purchase consisted
of an initial cash payment of $2.1 million and potential additional cash payments based upon future
financial performance of the acquired assets, not to exceed $700,000. Assets acquired include all
of the A.M. Surgical endoscopic soft tissue release products for the foot and ankle market, which
consists of the AM EPF (plantar fascia release), AM UDIN (interdigital
nerve decompression) and AM EGR (gastrocnemius release) Systems. These three systems
address the decompression and soft tissue release procedures most commonly performed by foot and
ankle surgeons. The A.M. Surgical product line is highly complementary to our line of
reconstructive and biologic products for flatfoot corrective surgery.
The operating results from this acquisition are included in the consolidated financial statements
from the acquisition date.
The acquisition was recorded by allocating the costs of the assets acquired based on their
estimated fair values at the acquisition date. The excess of the cost of the acquisition over the
net of amounts assigned to the fair value of the assets acquired is recorded as goodwill. The
following is a summary of the estimated fair values of the assets acquired, which includes
transaction costs (in thousands):
|
|
|
|
|
Intangible assets |
|
$ |
420 |
|
Goodwill |
|
|
1,740 |
|
|
|
|
|
Total assets acquired |
|
$ |
2,160 |
|
|
|
|
|
Creative Medical Designs, Inc. and Rayhack LLC. On September 4, 2008, we completed the acquisition
of all assets associated with the RAYHACK® Osteotomy Systems (Rayhack) for complex wrist
reconstruction. The purchase consists of an initial cash payment of $1.4 million and potential
additional cash payments based on the future financial performance of the purchased assets, not to
exceed $1.6 million.
The operating results from this acquisition are included in the consolidated financial statements
from the acquisition date.
The acquisition was recorded by allocating the costs of the assets acquired based on their
estimated fair values at the acquisition date. The fair value of the net assets acquired exceeded
the initial consideration for the acquisition by approximately $438,000. The excess was recorded as
a liability for contingent consideration. The following is a summary of the estimated fair values
of the assets acquired, which includes transaction costs (in thousands):
|
|
|
|
|
Inventory |
|
$ |
264 |
|
Property, plant and equipment |
|
|
104 |
|
Intangible assets |
|
|
1,460 |
|
Current liabilities |
|
|
(438 |
) |
|
|
|
|
Total assets acquired |
|
$ |
1,390 |
|
|
|
|
|
Of the $1.5 million of acquired intangible assets, $790,000 was assigned to customer relationships
(ten year useful life), $360,000 was assigned to registered trademarks (ten year useful life),
$280,000 was assigned to completed technology (ten year useful life), and $30,000 assigned to other
assets (five year useful life).
67
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
Our consolidated results of operations would not have been materially different than reported
results had the Inbone, A.M. Surgical and Rayhack acquisitions occurred at the beginning of 2008 or
2007.
4. Inventories
Inventories consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
9,502 |
|
|
$ |
7,020 |
|
Work-in-process |
|
|
34,811 |
|
|
|
21,482 |
|
Finished goods |
|
|
131,746 |
|
|
|
86,788 |
|
|
|
|
|
|
|
|
|
|
$ |
176,059 |
|
|
$ |
115,290 |
|
|
|
|
|
|
|
|
5. Assets Held for Sale
Assets held for sale consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Land and buildings |
|
$ |
|
|
|
$ |
1,766 |
|
Machinery and equipment |
|
|
|
|
|
|
441 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
2,207 |
|
|
|
|
|
|
|
|
In April 2008, we completed the sale of assets held for sale from our Toulon, France facility for
approximately $2.4 million, less costs to sell, plus the assumption of capital lease obligations
totaling approximately $700,000. See Note 16 for further discussion of our restructuring activities
associated with our Toulon, France facility.
6. Property, Plant and Equipment
Property, plant and equipment consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Land and land improvements |
|
$ |
4,073 |
|
|
$ |
4,050 |
|
Buildings |
|
|
22,709 |
|
|
|
7,272 |
|
Machinery and equipment |
|
|
42,675 |
|
|
|
35,534 |
|
Furniture, fixtures and office equipment |
|
|
31,620 |
|
|
|
30,424 |
|
Construction in progress |
|
|
9,963 |
|
|
|
5,931 |
|
Surgical instruments |
|
|
143,503 |
|
|
|
116,699 |
|
|
|
|
|
|
|
|
|
|
|
254,543 |
|
|
|
199,910 |
|
Less: Accumulated depreciation |
|
|
(120,892 |
) |
|
|
(100,873 |
) |
|
|
|
|
|
|
|
|
|
$ |
133,651 |
|
|
$ |
99,037 |
|
|
|
|
|
|
|
|
68
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
The components of property, plant and equipment recorded under capital leases consist of the
following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Buildings |
|
$ |
1,448 |
|
|
$ |
1,448 |
|
Machinery and equipment |
|
|
357 |
|
|
|
197 |
|
Furniture, fixtures and office equipment |
|
|
13 |
|
|
|
834 |
|
|
|
|
|
|
|
|
|
|
|
1,818 |
|
|
|
2,479 |
|
Less: Accumulated depreciation |
|
|
(655 |
) |
|
|
(1,374 |
) |
|
|
|
|
|
|
|
|
|
$ |
1,163 |
|
|
$ |
1,105 |
|
|
|
|
|
|
|
|
Depreciation expense approximated $26.5 million, $23.5 million and $21.4 million for the years
ended December 31, 2008, 2007, and 2006, respectively, and included amortization of assets under
capital leases.
7. Goodwill and Intangibles
Changes in the carrying amount of goodwill occurring during the year ended December 31, 2008, are
as follows (in thousands):
|
|
|
|
|
Goodwill at December 31, 2007 |
|
$ |
28,233 |
|
Goodwill from acquisitions during 2008 (see Note 3) |
|
|
20,821 |
|
Goodwill from contingent consideration associated with
acquisitions prior to 2008 |
|
|
1,078 |
|
Foreign currency translation |
|
|
(450 |
) |
|
|
|
|
Goodwill at December 31, 2008 |
|
$ |
49,682 |
|
|
|
|
|
During 2008, we made a payment totaling $57,000 as contingent consideration for the R&R Medical,
Inc. (R&R) acquisition completed in 2007, and a payment totaling $394,000 as contingent
consideration for the acquisition of the subtalar implant assets of Koby Ventures Ltd., d/b/a
Metasurg (Metasurg), which was completed in 2007. In addition, we recorded a liability for
contingent consideration to be paid in 2009 of $138,000 associated with the R&R acquisition and
$489,000 associated with the Metasurg acquisition.
The components of our identifiable intangible assets are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
December 31, 2007 |
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
Accumulated |
|
|
Cost |
|
Amortization |
|
Cost |
|
Amortization |
|
|
|
|
|
Distribution channels |
|
$ |
21,625 |
|
|
$ |
19,316 |
|
|
$ |
22,793 |
|
|
$ |
18,082 |
|
Completed technology |
|
|
12,163 |
|
|
|
4,006 |
|
|
|
5,180 |
|
|
|
2,896 |
|
Licenses |
|
|
6,301 |
|
|
|
3,504 |
|
|
|
3,598 |
|
|
|
2,561 |
|
Customer relationships |
|
|
3,650 |
|
|
|
371 |
|
|
|
1,490 |
|
|
|
110 |
|
Trademarks |
|
|
2,733 |
|
|
|
373 |
|
|
|
862 |
|
|
|
164 |
|
Other |
|
|
3,360 |
|
|
|
1,172 |
|
|
|
2,324 |
|
|
|
1,247 |
|
|
|
|
|
|
|
|
|
49,832 |
|
|
$ |
28,742 |
|
|
|
36,247 |
|
|
$ |
25,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: Accumulated
amortization |
|
|
(28,742 |
) |
|
|
|
|
|
|
(25,060 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
$ |
21,090 |
|
|
|
|
|
|
$ |
11,187 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
69
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
Based on the intangible assets held at December 31, 2008, we expect to amortize approximately $4.8
million in 2009, $2.3 million in 2010, $2.2 million in 2011, $2.1 million in 2012, and $1.8 million
in 2013.
8. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Employee benefits |
|
$ |
13,324 |
|
|
$ |
10,994 |
|
Royalties |
|
|
6,336 |
|
|
|
5,930 |
|
Taxes other than income |
|
|
6,154 |
|
|
|
5,320 |
|
Commissions |
|
|
6,092 |
|
|
|
5,628 |
|
Professional and legal fees |
|
|
7,155 |
|
|
|
6,239 |
|
Contingent consideration |
|
|
3,065 |
|
|
|
|
|
Restructuring liability (see Note 16) |
|
|
4,950 |
|
|
|
6,966 |
|
Other |
|
|
12,171 |
|
|
|
11,992 |
|
|
|
|
|
|
|
|
|
|
$ |
59,247 |
|
|
$ |
53,069 |
|
|
|
|
|
|
|
|
9. Long-Term Debt and Capital Lease Obligations
Long-term debt and capital lease obligations consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Capital lease obligations |
|
$ |
261 |
|
|
$ |
1,006 |
|
Convertible senior notes |
|
|
200,000 |
|
|
|
200,000 |
|
|
|
|
|
|
|
|
|
|
|
200,261 |
|
|
|
201,006 |
|
Less: current portion |
|
|
(125 |
) |
|
|
(551 |
) |
|
|
|
|
|
|
|
|
|
$ |
200,136 |
|
|
$ |
200,455 |
|
|
|
|
|
|
|
|
In April 2008, we sold certain assets of our Toulon, France facility. As part of that sale, the
buyer assumed our capital lease obligations of approximately $700,000 for certain machinery and
equipment located in that facility.
In November 2007, we issued $200 million of Convertible Senior Notes due 2014. The notes will
mature on December 1, 2014. The notes pay interest semiannually at an annual rate of 2.625% and are
convertible into shares of our common stock at an initial conversion rate of 30.6279 shares per
$1,000 principal amount of the notes, which represents a conversion price of $32.65 per share. The
holder of the notes may convert at any time on or prior to the close of business on the business
day immediately preceding the maturity date of notes. Beginning on December 6, 2011, we may redeem
the notes, in whole or in part, at a redemption price equal to 100% of the principal amount of the
notes, plus accrued and unpaid interest, if the closing price of our common stock has exceeded 140%
of the conversion price for at least 20 days during any consecutive 30-day trading period.
Additionally, if we experience a fundamental change event, as defined in the note agreement, the
holders may require us to purchase for cash all or a portion of the notes, for 100% of the
principal amount of the notes, plus accrued and unpaid interest. If upon a fundamental change
event, a holder elects to convert its notes, we may, under certain circumstances, increase the
conversion rate for the notes surrendered. The notes are unsecured obligations and are
subordinated to all existing and future secured debt, our revolving credit facility, and all
liabilities of our subsidiaries.
On December 31, 2008, our revolving credit facility had availability of $100 million, which can be
increased by up to an additional $50 million at our request and subject to the agreement of the
lenders. We currently have no borrowings outstanding under the credit facility. Borrowings under
the credit facility will bear interest at the sum of
70
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
an annual base rate plus an applicable annual
rate that ranges from 0% to 1.75% depending on the type of loan and our consolidated leverage
ratio, with a current annual base rate of 3.25%. The term of the credit facility extends through
June 30, 2011.
As discussed in Note 6, we have acquired certain property and equipment pursuant to capital leases.
At December 31, 2008, future minimum lease payments under capital lease obligations, together with
the present value of the net minimum lease payments, are as follows (in thousands):
|
|
|
|
|
2009 |
|
$ |
136 |
|
2010 |
|
|
104 |
|
2011 |
|
|
28 |
|
2012 |
|
|
6 |
|
2013 |
|
|
3 |
|
|
|
|
|
Total minimum payments |
|
|
277 |
|
Less amount representing interest |
|
|
(16 |
) |
|
|
|
|
Present value of minimum lease payments |
|
|
261 |
|
Current portion |
|
|
(125 |
) |
|
|
|
|
Long-term portion |
|
$ |
136 |
|
|
|
|
|
10. Other Long-Term Liabilities
Other long-term liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Unrecognized tax benefits (see Note 11) |
|
$ |
1,814 |
|
|
$ |
6,154 |
|
Other |
|
|
3,137 |
|
|
|
1,052 |
|
|
|
|
|
|
|
|
|
|
$ |
4,951 |
|
|
$ |
7,206 |
|
|
|
|
|
|
|
|
11. Income Taxes
The components of our income before income taxes are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Domestic |
|
$ |
3,036 |
|
|
$ |
10,981 |
|
|
$ |
34,624 |
|
Foreign |
|
|
18,534 |
|
|
|
(8,650 |
) |
|
|
(12,423 |
) |
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
$ |
21,570 |
|
|
$ |
2,331 |
|
|
$ |
22,201 |
|
|
|
|
|
|
|
|
|
|
|
71
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
The components of our provision for income taxes are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Current provision (benefit): |
|
|
|
|
|
|
|
|
|
|
|
|
Domestic: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
3,192 |
|
|
$ |
7,590 |
|
|
$ |
13,257 |
|
State |
|
|
(720 |
) |
|
|
660 |
|
|
|
1,841 |
|
Foreign |
|
|
(2,880 |
) |
|
|
1,397 |
|
|
|
2,234 |
|
Deferred (benefit) provision: |
|
|
|
|
|
|
|
|
|
|
|
|
Domestic: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
(2,812 |
) |
|
|
(4,333 |
) |
|
|
(2,915 |
) |
State |
|
|
(105 |
) |
|
|
(329 |
) |
|
|
(361 |
) |
Foreign |
|
|
21,698 |
|
|
|
(3,615 |
) |
|
|
(6,266 |
) |
|
|
|
|
|
|
|
|
|
|
Total provision for income taxes |
|
$ |
18,373 |
|
|
$ |
1,370 |
|
|
$ |
7,790 |
|
|
|
|
|
|
|
|
|
|
|
A reconciliation of the statutory U.S. federal income tax rate to our effective income tax rate is
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2008 |
|
2007 |
|
2006 |
Income tax provision at statutory rate |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
State income taxes |
|
|
(4.4 |
)% |
|
|
12.2 |
% |
|
|
5.3 |
% |
Stock-based compensation expense |
|
|
6.6 |
% |
|
|
132.9 |
% |
|
|
11.3 |
% |
Change in valuation allowance |
|
|
59.1 |
% |
|
|
(3.6 |
)% |
|
|
(2.8 |
)% |
Research and development credit |
|
|
(8.5 |
)% |
|
|
(51.2 |
)% |
|
|
(4.2 |
)% |
Foreign income tax rate differences |
|
|
(5.6 |
)% |
|
|
(70.0 |
)% |
|
|
(4.5 |
)% |
Non-taxable differences and other, net |
|
|
3.0 |
% |
|
|
3.5 |
% |
|
|
(5.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
85.2 |
% |
|
|
58.8 |
% |
|
|
35.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
72
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
The significant components of our deferred income taxes as of December 31, 2008 and 2007 are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
$ |
22,667 |
|
|
$ |
32,255 |
|
General business credit carryforward |
|
|
1,854 |
|
|
|
2,262 |
|
Reserves and allowances |
|
|
23,640 |
|
|
|
20,537 |
|
Stock-based compensation expense |
|
|
7,464 |
|
|
|
5,907 |
|
Amortization |
|
|
2,056 |
|
|
|
3,956 |
|
Other |
|
|
13,699 |
|
|
|
14,116 |
|
Valuation allowance |
|
|
(18,512 |
) |
|
|
(6,026 |
) |
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
52,868 |
|
|
|
73,007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
9,121 |
|
|
|
6,140 |
|
Intangible assets |
|
|
4,237 |
|
|
|
1,715 |
|
Other |
|
|
6,794 |
|
|
|
10,778 |
|
|
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
|
20,152 |
|
|
|
18,633 |
|
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
32,716 |
|
|
$ |
54,374 |
|
|
|
|
|
|
|
|
Outside basis differences that have not been tax-effected in accordance with the provisions of
Accounting Principles Board Opinion No. 23, Accounting for Income Taxes Special Areas, as
amended by SFAS No. 109, are primarily related to undistributed earnings of certain of our foreign
subsidiaries. Deferred tax liabilities for U.S. federal income taxes are not provided on the
undistributed earnings of our foreign subsidiaries that are considered permanently reinvested. The
determination of the amount of unrecognized deferred tax liability is not practicable.
At December 31, 2008, we had net operating loss carryforwards for U.S. federal income tax purposes
of approximately $12.2 million, which begin to expire in 2017. Additionally, we had general
business credit carryforwards of approximately $1.9 million, which expire beginning in 2009 and
extend through 2016. At December 31, 2008, we had foreign net operating loss carryforwards of
approximately $55.8 million, of which approximately $5.2 million expires beginning in 2009 and
extending through 2015.
Certain of our U.S. and foreign net operating losses and general business credit carryforwards are
subject to various limitations. We maintain valuation allowances for those net operating losses and
tax credit carryforwards that we do not expect to utilize due to these limitations. During the year
ended December 31, 2008, we recognized a tax provision of $12.8 million to record a valuation
allowance, primarily for deferred tax assets associated with net operating losses in France.
Effective January 1, 2007, we adopted FIN 48, which clarifies the accounting for uncertainty in
income taxes recognized in a companys financial statements in accordance with SFAS No. 109 by
defining the criterion that an individual tax position must meet in order to be recognized in the
financial statements. FIN 48 requires that the tax effects of a position be recognized only if it
is more-likely-than-not to be sustained based solely on the technical merits as of the reporting
date.
73
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows:
|
|
|
|
|
Balance at January 1, 2008 |
|
$ |
6,154 |
|
Additions for tax positions related to current year |
|
|
361 |
|
Additions for tax positions of prior years |
|
|
58 |
|
Reductions for tax positions of prior years |
|
|
(106 |
) |
Settlements |
|
|
(4,336 |
) |
Foreign currency translation |
|
|
(317 |
) |
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
1,814 |
|
|
|
|
|
As of December 31, 2008, our liability for unrecognized tax benefits totaled $1.8 million and is
recorded in our consolidated balance sheet within Other liabilities, all of which, if recognized,
would affect our effective tax rate. In December 2008, we effectively settled a tax audit of
certain of our French subsidiaries, resulting in a reduction of our unrecognized tax benefit in the
amount of $4.3 million. Management does not believe that it is reasonably possible that our
unrecognized tax benefits will significantly change within the next twelve months.
FIN 48 further requires that interest required to be paid by the tax law on the underpayment of
taxes should be accrued on the difference between the amount claimed or expected to be claimed on
the tax return and the tax benefit recognized in the financial statements. Management has made the
policy election to record this interest as interest expense. As of December 31, 2008, accrued
interest related to our unrecognized tax benefits totaled approximately $60,000, which is recorded
in our consolidated balance sheet within Other liabilities.
We file numerous consolidated and separate company income tax returns in the U.S. and in many
foreign jurisdictions, with the most significant foreign jurisdiction being France. We are no
longer subject to foreign income tax examinations by tax authorities for years before 2000. With
few exceptions, we are subject to U.S. federal, state and local income tax examinations for years
2005 through 2007. However, tax authorities have the ability to review years prior to these to the
extent that we utilize tax attributes carried forward from those prior years.
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 our common stock equivalents. Our common stock equivalents consist of stock options,
non-vested shares of common stock and convertible debt. The dilutive effect of the stock options
and non-vested shares of common stock is calculated using the treasury-stock method. The dilutive
effect of convertible debt is calculated by applying the if-converted method. This method assumes
an add-back of interest, net of income taxes, to net income as if the securities were converted at
the beginning of the period. We determined that for the year ended December 31, 2008, the
convertible debt had an anti-dilutive effect on earnings per share and therefore excluded it from
the dilutive shares calculation.
74
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
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, |
|
|
2008 |
|
2007 |
|
2006 |
Weighted-average number of common
shares outstanding basic |
|
|
36,933 |
|
|
|
35,812 |
|
|
|
34,434 |
|
Common stock equivalents |
|
|
468 |
|
|
|
671 |
|
|
|
1,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common
shares outstanding diluted |
|
|
37,401 |
|
|
|
36,483 |
|
|
|
35,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following potential common shares were excluded from the computation of diluted earnings per
share as their effect would have been anti-dilutive (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2008 |
|
2007 |
|
2006 |
Stock options |
|
|
2,604 |
|
|
|
3,328 |
|
|
|
4,446 |
|
Non-vested shares |
|
|
502 |
|
|
|
43 |
|
|
|
|
|
Convertible debt |
|
|
6,126 |
|
|
|
6,126 |
|
|
|
|
|
13. Capital Stock
We are authorized to issue up to 100,000,000 shares of voting common stock. We have 61,978,039
shares of voting common stock available for future issuance at December 31, 2008.
14. Stock-Based Compensation Plans
We have two stock-based compensation plans which are described below. Amounts recognized in the
financial statements with respect to these plans are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Total cost of share-based payment plans |
|
$ |
13,223 |
|
|
$ |
16,425 |
|
|
$ |
14,845 |
|
Amounts capitalized as inventory and intangible assets |
|
|
(1,492 |
) |
|
|
(2,262 |
) |
|
|
(1,918 |
) |
Amortization of capitalized amounts |
|
|
1,770 |
|
|
|
2,369 |
|
|
|
913 |
|
|
|
|
|
|
|
|
|
|
|
Charged against income before income taxes |
|
|
13,501 |
|
|
|
16,532 |
|
|
|
13,840 |
|
Amount of related income tax benefit recognized income |
|
|
(3,674 |
) |
|
|
(3,665 |
) |
|
|
(2,957 |
) |
|
|
|
|
|
|
|
|
|
|
Impact to net income |
|
$ |
9,827 |
|
|
$ |
12,867 |
|
|
$ |
10,883 |
|
|
|
|
|
|
|
|
|
|
|
Impact to basic earnings per share |
|
$ |
0.27 |
|
|
$ |
0.36 |
|
|
$ |
0.32 |
|
|
|
|
|
|
|
|
|
|
|
Impact to diluted earnings per share |
|
$ |
0.26 |
|
|
$ |
0.35 |
|
|
$ |
0.31 |
|
|
|
|
|
|
|
|
|
|
|
In the year ended December 31, 2008, we granted approximately 553,000 non-vested shares of common
stock and 559,000 options to purchase common stock at a weighted-average fair value of $28.07 and
$11.17, respectively, which will be recognized on a straight line basis over the requisite service
period that, for the substantial majority of these grants, is four years. As of December 31, 2008,
we had approximately 4.0 million stock options outstanding, of which approximately 2.6 million were
exercisable and 796,000 non-vested shares of common stock outstanding.
As of December 31, 2008, we had $25.2 million of total unrecognized compensation cost related to
unvested stock-based compensation arrangements granted to employees. That cost is expected to be
recognized over a weighted-average period of 2.8 years.
75
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
Equity Incentive Plan. On December 7, 1999, we adopted the 1999 Equity Incentive Plan (the Plan),
which was subsequently amended and restated on July 6, 2001, May 13, 2003, May 13, 2004, May 12,
2005 and May 14, 2008 and amended on October 23, 2008. The Plan authorizes us to grant stock
options and other stock-based awards, such as non-vested shares of common stock, with respect to up
to 10,467,051 shares of common stock, of which full value awards (such as non-vested shares) are
limited to 1,279,555 shares. Under the Plan, options to purchase common stock generally are
exercisable in increments of 25% annually on 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 we
completed our IPO in July 2001 became options to purchase our common stock. Those options were
immediately exercisable upon their issuance. All of the options issued under the Plan expire after
ten years. Non-vested shares of common stock are generally vested in increments of 25% annually on
each of the first through fourth anniversaries of the date of grant. As of December 31, 2008, there
were 933,911 shares available for future issuance under the Plan, of which full value awards are
limited to 367,017 shares.
Stock options
We estimate the fair value of stock options using the Black-Scholes valuation model. The
Black-Scholes option-pricing model requires the input of estimates, including the expected life of
stock options, expected stock price volatility, the risk-free interest rate and the expected
dividend yield. The expected life of options is estimated by calculating the average of the vesting
term and the contractual term of the option, as allowed in SEC Staff Accounting Bulletin No. 107.
The expected stock price volatility assumption was estimated based upon historical volatility of
our common stock. The risk-free interest rate was determined using U.S. Treasury rates where the
term is consistent with the expected life of the stock options. Expected dividend yield is not
considered as we have never paid dividends and have no plans of doing so in the future. We are
required to estimate forfeitures at the time of grant and revise those estimates in subsequent
periods if actual forfeitures differ from those estimates. We use historical data to estimate
pre-vesting forfeitures and record stock-based compensation expense only for those awards that are
expected to vest. The fair value of stock options is amortized on a straight-line basis over the
respective requisite service period, which is generally the vesting period.
The weighted-average grant date fair value of stock options granted to employees in 2008, 2007 and
2006 was $11.17 per share, $11.30 per share and $9.97 per share, respectively. The fair value of
each option grant is estimated on the date of grant using the Black-Scholes option valuation model
using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2008 |
|
2007 |
|
2006 |
Risk-free interest rate |
|
2.0% - 3.4% |
|
3.9% - 4.8% |
|
4.3% - 5.1% |
Expected option life |
|
6 years |
|
6 years |
|
6 years |
Expected price volatility |
|
36% |
|
39% |
|
40% |
During 2006, we granted certain independent distributors stock options totaling 66,700 shares under
the Plan. These options are exercisable in 25% increments on the first through fourth anniversaries
of the date of grant at a weighted-average exercise price of $22.43 per share. The options expire
after ten years.
76
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
A summary of our stock option activity during 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Aggregate |
|
|
|
|
|
|
|
Weighted- |
|
|
Average |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Average |
|
|
Remaining |
|
|
Value* |
|
|
|
(000s) |
|
|
Exercise Price |
|
|
Contractual Life |
|
|
($000s) |
|
Outstanding at December 31, 2007 |
|
|
4,428 |
|
|
$ |
23.51 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
559 |
|
|
|
27.13 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(602 |
) |
|
|
19.47 |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(339 |
) |
|
|
27.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2008 |
|
|
4,046 |
|
|
$ |
24.32 |
|
|
6.6 years |
|
$ |
2,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2008 |
|
|
2,595 |
|
|
$ |
24.30 |
|
|
5.7 years |
|
$ |
2,329 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
The aggregate intrinsic value is calculated as the difference between the market value of our
common stock as of December 31, 2008, and the exercise price of the shares. The market value
as of December 31, 2008 is $20.43 per share, which is the closing sale price of our common
stock reported for transactions effected on the Nasdaq Global Select Market on December 31,
2008. |
The total intrinsic value of options exercised during 2008, 2007 and 2006 was $5.9 million, $17.3
million and $15.2 million, respectively.
A summary of our stock options outstanding and exercisable at December 31, 2008, is as follows
(shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Options Exercisable |
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Weighted-Average |
|
|
-Average |
|
|
|
|
|
|
-Average |
|
|
|
Number |
|
|
Remaining |
|
|
Exercise |
|
|
Number |
|
|
Exercise |
|
Range of Exercise Prices |
|
Outstanding |
|
|
Contractual Life |
|
|
Price |
|
|
Exercisable |
|
|
Price |
|
$0.00 $8.50 |
|
|
90 |
|
|
1.5 years |
|
$ |
5.11 |
|
|
|
90 |
|
|
$ |
5.11 |
|
$8.51 $16.00 |
|
|
30 |
|
|
3.9 years |
|
|
15.05 |
|
|
|
30 |
|
|
|
15.05 |
|
$16.01 $24.00 |
|
|
1,683 |
|
|
6.8 years |
|
|
20.93 |
|
|
|
969 |
|
|
|
20.85 |
|
$24.01 $32.00 |
|
|
2,183 |
|
|
6.7 years |
|
|
27.57 |
|
|
|
1,446 |
|
|
|
27.59 |
|
$32.01 $35.87 |
|
|
60 |
|
|
5.3 years |
|
|
34.25 |
|
|
|
60 |
|
|
|
34.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,046 |
|
|
6.6 years |
|
$ |
24.32 |
|
|
|
2,595 |
|
|
$ |
24.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested shares
We calculate the grant date fair value of non-vested shares of common stock as the average of
the highest and lowest reported sale prices on the trading day immediately prior to the grant
date. We are required to estimate forfeitures at the time of grant and revise those estimates
in subsequent periods if actual forfeitures differ from those estimates. We use historical
data to estimate pre-vesting forfeitures and record stock-based compensation expense only for
those awards that are expected to vest.
We granted 526,000, 409,000 and 7,000 non-vested shares of common stock to employees with
weighted-average fair values of $28.15 per share, $24.32 per share, and $23.37 per share
during 2008, 2007 and 2006, respectively. The fair value of these shares will be recognized on
a straight-line basis over the respective requisite service period, which is generally the
vesting period.
77
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
During both 2008 and 2007, we granted certain independent distributors and other non-employees
non-vested shares of common stock of 27,000 shares under the Plan at a weighted-average grant date
fair values of $26.49 per share and $22.83 per share, respectively.
During 2006, we issued 50,000 non-vested shares of common stock with a grant date fair value of
$22.44 per share to a third party in exchange for certain rights and services. The expense
related to those shares was recognized over 28 months, the life of the contract. The
forfeiture restrictions lapsed on 16,667 of these shares on the grant date, on 16,667 of these shares on January 1, 2007 and the remaining shares lapsed on January 1, 2008.
A summary of our non-vested shares of common stock activity during 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Aggregate |
|
|
|
|
|
|
|
Average |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Grant-Date |
|
|
Value* |
|
|
|
(000s) |
|
|
Fair Value |
|
|
($000s) |
|
Non-vested at December 31, 2007 |
|
|
449 |
|
|
$ |
23.91 |
|
|
|
|
|
Granted |
|
|
553 |
|
|
|
28.07 |
|
|
|
|
|
Vested |
|
|
(126 |
) |
|
|
24.40 |
|
|
|
|
|
Forfeited |
|
|
(80 |
) |
|
|
25.78 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested at December 31, 2008 |
|
|
796 |
|
|
$ |
26.75 |
|
|
$ |
16,254 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
The aggregate intrinsic value is calculated as the market value of our common stock as of
December 31, 2008. The market value as of December 31, 2008 is $20.43 per share, which is the
closing sale price of our common stock reported for transactions effected on the Nasdaq Global
Select Market on December 31, 2008. |
The total fair value of shares vested during 2008 and 2007 was $2.6 million and $436,000,
respectively.
Employee Stock Purchase Plan. On May 30, 2002, our shareholders approved and adopted the 2002
Employee Stock Purchase Plan (the ESPP). The ESPP authorizes us to issue up to 200,000 shares of
common stock to our 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 our 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, we sold to employees
14,690, 11,032 and 11,465 shares in 2008, 2007 and 2006, respectively, with weighted-average fair
values of $9.09, $7.73 and $6.88 per share, respectively. As of December 31, 2008, there were
124,032 shares available for future issuance under the ESPP. During 2008, 2007 and 2006, we
recorded nominal amounts of non-cash, stock-based compensation expense related to the ESPP.
In applying the Black-Scholes methodology to the purchase rights granted under the ESPP, we used
the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2008 |
|
2007 |
|
2006 |
Risk-free interest rate |
|
2.9% - 3.3% |
|
4.6% - 4.8% |
|
4.6% - 4.8% |
Expected option life |
|
6 months |
|
6 months |
|
6 months |
Expected price volatility |
|
36% |
|
39% |
|
40% |
78
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
15. Employee Benefit Plans
We sponsor 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, we match 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 our
contributions after three years of service. Our expense related to the plan was $1.4 million, $1.2
million and $1.0 million in 2008, 2007 and 2006, respectively.
16. Restructuring
In June 2007, we announced plans to close our manufacturing, distribution and administrative
facility located in Toulon, France. The facilitys closure affected approximately 130 Toulon-based
employees. The majority of our restructuring activities were complete by the end of 2007, with
production now conducted solely in our existing manufacturing facility in Arlington, Tennessee and
the distribution activities being carried out from our European headquarters in Amsterdam, the
Netherlands.
Management estimates that the pre-tax restructuring charges will total approximately $28 million to
$32 million. These charges consist of the following estimates:
|
|
|
$14 million for severance and other termination benefits; |
|
|
|
|
$3 million of non-cash asset impairments of property, plant and equipment; |
|
|
|
|
$2 million of inventory write-offs and manufacturing period costs; |
|
|
|
|
$3 million to $4 million of external legal and professional fees; and |
|
|
|
|
$6 million to $9 million of other cash and non-cash charges (including employee
litigation). |
Charges associated with the restructuring are presented in the following table. All of the
following amounts were recognized within Restructuring charges in our consolidated statement of
operations, with the exception of the inventory write-offs and manufacturing period costs, which
were recognized with Cost of sales restructuring.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
Year Ended |
|
|
Charges as of |
|
(in thousands) |
|
December 31, 2008 |
|
|
December 31, 2008 |
|
Severance and other termination benefits |
|
$ |
1,918 |
|
|
$ |
13,593 |
|
Employee litigation accrual |
|
|
3,841 |
|
|
|
4,161 |
|
Asset impairment charges |
|
|
(63 |
) |
|
|
3,093 |
|
Inventory write-offs and manufacturing
period costs |
|
|
|
|
|
|
2,139 |
|
Legal/professional fees |
|
|
822 |
|
|
|
2,369 |
|
Other |
|
|
187 |
|
|
|
223 |
|
|
|
|
|
|
|
|
Total restructuring charges |
|
$ |
6,705 |
|
|
$ |
25,578 |
|
|
|
|
|
|
|
|
As a result of the plans to close the facilities in 2007, we performed an evaluation of the
undiscounted future cash flows of the related asset group and recorded an impairment charge in 2007
for the difference between the net book value of the assets and their estimated fair values for
those assets we intended to sell. In April 2008, these assets were sold. We also recorded an
impairment charge in 2007 for assets to be abandoned.
79
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
Activity in the restructuring liability for the year ended December 31, 2008 is presented in the
following table (in thousands):
|
|
|
|
|
Beginning balance as of December 31, 2007 |
|
$ |
6,966 |
|
Charges: |
|
|
|
|
Severance and other termination benefits |
|
|
2,125 |
|
Litigation accrual |
|
|
3,841 |
|
Legal/professional fees |
|
|
822 |
|
Other |
|
|
187 |
|
|
|
|
|
Total accruals |
|
$ |
6,975 |
|
|
|
|
|
|
Payments: |
|
|
|
|
Severance and other termination benefits |
|
|
(7,394 |
) |
Legal/professional fees |
|
|
(976 |
) |
Other |
|
|
(117 |
) |
|
|
|
|
|
|
$ |
(8,487 |
) |
|
|
|
|
|
Changes in foreign currency translation |
|
|
(504 |
) |
|
|
|
|
Restructuring liability at December 31, 2008 |
|
$ |
4,950 |
|
|
|
|
|
In connection with the closure of our Toulon, France facility, a majority of our former employees
have filed claims to challenge the economic justification for their dismissal. Management has
accrued $3.8 million associated with these claims as of December 31, 2008. This liability is
recorded within Accrued expenses and other current liabilities in our consolidated balance sheet
as of December 31, 2008.
17. Commitments and Contingencies
Operating Leases. We lease certain equipment and office space under non-cancelable operating
leases. Rental expense under operating leases approximated $10.1 million, $9.7 million and $8.5
million for the years ended December 31, 2008, 2007 and 2006, 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, 2008 (in thousands):
|
|
|
|
|
2009 |
|
$ |
8,377 |
|
2010 |
|
|
5,693 |
|
2011 |
|
|
2,725 |
|
2012 |
|
|
621 |
|
2013 |
|
|
391 |
|
Thereafter |
|
|
447 |
|
|
|
|
|
|
|
$ |
18,254 |
|
|
|
|
|
80
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
Royalty and Consulting Agreements. We have entered into various royalty and other consulting
agreements with third party consultants. We incurred royalty and consulting expenses of $875,000,
$855,000 and $1.0 million during the years ended December 31, 2008, 2007 and 2006, respectively, under non-cancelable
contracts with minimum 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. Future minimum
payments under these agreements for which we have not recorded a liability are as follows at
December 31, 2008 (in thousands):
|
|
|
|
|
2009 |
|
$ |
815 |
|
2010 |
|
|
573 |
|
2011 |
|
|
573 |
|
2012 |
|
|
573 |
|
2013 |
|
|
518 |
|
Thereafter |
|
|
1,344 |
|
|
|
|
|
|
|
$ |
4,396 |
|
|
|
|
|
Purchase Obligations. We have entered into certain supply agreements for our products, which
include minimum purchase obligations. During the years ended December 31, 2008, 2007 and 2006, we
paid approximately $4.5 million, $2.3 million and $3.8 million, respectively, under those supply
agreements. Our remaining purchase obligations under those supply agreements are as follows at
December 31, 2008 (in thousands):
|
|
|
|
|
2009 |
|
$ |
2,543 |
|
2010 |
|
|
2,543 |
|
2011 |
|
|
2,543 |
|
|
|
|
|
|
|
$ |
7,629 |
|
|
|
|
|
Portions of our payments for operating leases, royalty and consulting agreements, and purchase
obligations are denominated in foreign currencies and were translated in the tables above based on
their respective U.S. dollar exchange rates at December 31, 2008. These future payments are subject
to foreign currency exchange rate risk.
Legal Proceedings. In 2000, Howmedica Osteonics Corp. (Howmedica), 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 are vigorously defending this lawsuit. In November 2005, the District Court
issued a Markman ruling on claim construction. Howmedica conceded to the District Court that, if
the claim construction as issued was applied to our knee product line, our products do not infringe
their patent. Howmedica appealed the Markman ruling. In September 2008, the U.S. Court of Appeals
for the Federal Circuit overturned the District Courts Markman ruling on claim construction. The
case was remanded to the District Court for further proceedings on alleged infringement and on our
affirmative defenses, which include patent invalidity and unenforceability. 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, 2008. These 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 our consolidated financial position or results of operations.
We are involved in separate disputes in Italy with a former agent and two former employees.
Management believes that we have meritorious defenses to the 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, 2008.
81
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
In December 2007, we received a subpoena from the U.S. Department of Justice (DOJ) through the U.S.
Attorney for the District of New Jersey requesting documents for the period January 1998 through the present
related to any consulting and professional service agreements with orthopaedic surgeons in
connection with hip or knee joint replacement procedures or products. This subpoena was served
shortly after several of our knee and hip competitors agreed to resolutions with the DOJ after
being subjects of investigation involving the same subject matter. We are cooperating fully with
the DOJ request. We cannot estimate what, if any, impact any results from this inquiry could have
on our consolidated results of operations or financial position.
In June 2008, we received a letter from the SEC informing us that it is conducting an informal
investigation regarding potential violations of the Foreign Corrupt Practices Act in the sale of
medical devices in a number of foreign countries by companies in the medical device industry. We
understand that several other medical device companies have received similar letters. We are
cooperating fully with the SEC request. We cannot estimate what, if any, impact any results from
this inquiry could have on our consolidated results of operations or financial position.
In late 2004 and early 2005, approximately 120 plaintiffs sued Dr. John King in the Circuit Court
of Putnam County, West Virginia. Plaintiffs allege that Dr. King was professionally negligent when
he performed surgery on the plaintiffs at Putnam General Hospital in Putnam County, West Virginia
between November 2002 and June 2003. In 33 of the lawsuits, plaintiffs alleged that Dr. King
inappropriately used a biologic product sold by us. In these lawsuits, plaintiffs named Wright as a
defendant and allege that our products had not been properly cleared by the United States Food and
Drug Administration, that we failed to warn that our products were not safe for their intended use,
and that we knew that Dr. King was not properly trained or was performing the surgeries
inappropriately. Plaintiffs also allege that we and two other co-defendants entered into a joint
venture with Dr. King and/or his physician assistant, David McNair, such that we could be held
liable for his/their conduct. Plaintiffs further assert claims based on strict liability, express
and implied breach of warranty, civil conspiracy and negligence. They seek damages related to
alleged lost income, medical expenses, future medical and life care expenses, damages relating to
pain and suffering and punitive and other damages.
In July 2007, a Putnam County jury found that Putnam General Hospital had negligently credentialed
Dr. King and that the hospitals conduct in credentialing Dr. King was motivated by fraud, ill
will, wantonness, oppressiveness or by reckless or gross negligence, which allowed the plaintiffs
to seek punitive damages against the hospital. In the second quarter of 2008, the hospital, its
affiliates and David McNair entered into confidential settlements of all claims with all but one of
the plaintiffs. EBI, LLC (a subsidiary of Biomet, Inc.), Wright, an independent contractor of one
of our distributors, and Dr. King remain as defendants in the litigation.
The first consolidated trial of six plaintiffs is scheduled to begin in the Putnam County Circuit
Court in June 2009. We have product liability insurance which may or may not cover some or all of
the ultimate resolution of this litigation. While we believe our legal and factual defenses to
these claims are strong, and will continue to vigorously defend against these claims, it is
possible that the outcome of these cases will have a material adverse effect on our consolidated
financial position or results of operations however an amount cannot be estimated.
In addition to those noted above, we are 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 our consolidated results of operations or financial position.
18. Segment Data
We have one reportable segment, orthopaedic products, which includes the design, manufacture and
marketing of reconstructive joint devices and biologics products. Our 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
82
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
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 product line and information by geographic region are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Net sales by product line: |
|
|
|
|
|
|
|
|
|
|
|
|
Hip products |
|
$ |
160,788 |
|
|
$ |
134,251 |
|
|
$ |
122,073 |
|
Knee products |
|
|
119,895 |
|
|
|
102,334 |
|
|
|
94,079 |
|
Biologics products |
|
|
82,399 |
|
|
|
76,029 |
|
|
|
65,455 |
|
Extremity products |
|
|
88,890 |
|
|
|
62,302 |
|
|
|
45,044 |
|
Other |
|
|
13,575 |
|
|
|
11,934 |
|
|
|
12,287 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
465,547 |
|
|
$ |
386,850 |
|
|
$ |
338,938 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales by geographic region: |
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
282,081 |
|
|
$ |
235,748 |
|
|
$ |
211,015 |
|
Europe |
|
|
112,771 |
|
|
|
96,336 |
|
|
|
82,197 |
|
Other |
|
|
70,695 |
|
|
|
54,766 |
|
|
|
45,726 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
465,547 |
|
|
$ |
386,850 |
|
|
$ |
338,938 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) by geographic
region: |
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
|
21,546 |
|
|
|
13,911 |
|
|
|
18,752 |
|
Europe |
|
|
(14,909 |
) |
|
|
(22,835 |
) |
|
|
(7,563 |
) |
Other |
|
|
15,776 |
|
|
|
10,378 |
|
|
|
8,242 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
22,413 |
|
|
|
1,454 |
|
|
|
19,431 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Long-lived assets: |
|
|
|
|
|
|
|
|
United States |
|
$ |
104,058 |
|
|
$ |
71,764 |
|
Europe |
|
|
18,192 |
|
|
|
18,605 |
|
Other |
|
|
11,401 |
|
|
|
8,668 |
|
|
|
|
|
|
|
|
Total |
|
$ |
133,651 |
|
|
$ |
99,037 |
|
|
|
|
|
|
|
|
No single foreign country accounted for more than 10% of our total net sales during 2008, 2007 or
2006; however, the largest single foreign country represented approximately 8%, 7% and 7% of our
total net sales in 2008, 2007 and 2006, respectively.
During 2008 and 2007, our operating income included restructuring charges associated with the
closure of our facility in Toulon, France. Our U.S. region recognized $1.6 million and $2.5 million
of restructuring charges in 2008 and 2007, respectively, and our European region recognized $5.1
million and $16.4 million of restructuring charges in 2008 and 2007, respectively. Additionally, in
2008, our U.S. region recognized $7.6 million of charges related to the ongoing U.S. government
inquiries, $2.6 million related to an unfavorable appellate court decision and $2.5 million of
acquired in-process research and development costs related to our Inbone acquisition. In 2007, our
U.S. region recognized a $3.3 million charge in 2007 as a result of an unfavorable ruling under
binding arbitration.
83
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
19. Quarterly Results of Operations (unaudited):
The following table presents a summary of our unaudited quarterly operating results for each of the
four quarters in 2008 and 2007, 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
First |
|
|
Second |
|
|
Third |
|
|
Fourth |
|
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
Net sales |
|
$ |
115,865 |
|
|
$ |
118,477 |
|
|
$ |
111,096 |
|
|
$ |
120,109 |
|
Cost of sales |
|
|
32,438 |
|
|
|
34,811 |
|
|
|
32,038 |
|
|
|
35,090 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
83,427 |
|
|
|
83,666 |
|
|
|
79,058 |
|
|
|
85,019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
66,589 |
|
|
|
68,875 |
|
|
|
61,897 |
|
|
|
64,035 |
|
Research and development |
|
|
7,999 |
|
|
|
8,378 |
|
|
|
8,338 |
|
|
|
8,577 |
|
Amortization of intangible assets |
|
|
1,041 |
|
|
|
1,276 |
|
|
|
1,287 |
|
|
|
1,270 |
|
Restructuring charges |
|
|
1,815 |
|
|
|
3,095 |
|
|
|
685 |
|
|
|
1,110 |
|
Acquired in-process research and
development |
|
|
|
|
|
|
2,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
77,444 |
|
|
|
84,114 |
|
|
|
72,207 |
|
|
|
74,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
$ |
5,983 |
|
|
$ |
(448 |
) |
|
$ |
6,851 |
|
|
$ |
10,027 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
4,058 |
|
|
$ |
(2,357 |
) |
|
$ |
4,187 |
|
|
$ |
(2,691 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share, basic |
|
$ |
0.11 |
|
|
$ |
(0.06 |
) |
|
$ |
0.11 |
|
|
$ |
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share, diluted |
|
$ |
0.11 |
|
|
$ |
(0.06 |
) |
|
$ |
0.11 |
|
|
$ |
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
|
First |
|
|
Second |
|
|
Third |
|
|
Fourth |
|
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
Net sales |
|
$ |
94,287 |
|
|
$ |
98,008 |
|
|
$ |
91,399 |
|
|
$ |
103,156 |
|
Cost of sales |
|
|
26,965 |
|
|
|
28,770 |
|
|
|
24,268 |
|
|
|
28,404 |
|
Cost of sales restructuring |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
67,322 |
|
|
|
69,238 |
|
|
|
67,131 |
|
|
|
72,613 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
53,926 |
|
|
|
56,307 |
|
|
|
54,573 |
|
|
|
61,123 |
|
Research and development |
|
|
8,102 |
|
|
|
6,853 |
|
|
|
7,151 |
|
|
|
6,299 |
|
Amortization of intangible assets |
|
|
855 |
|
|
|
970 |
|
|
|
968 |
|
|
|
989 |
|
Restructuring charges |
|
|
|
|
|
|
7,539 |
|
|
|
6,966 |
|
|
|
2,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
62,883 |
|
|
|
71,669 |
|
|
|
69,658 |
|
|
|
70,640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
$ |
4,439 |
|
|
$ |
(2,431 |
) |
|
$ |
(2,527 |
) |
|
$ |
1,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
3,189 |
|
|
$ |
(2,090 |
) |
|
$ |
(1,522 |
) |
|
$ |
1,384 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share, basic |
|
$ |
0.09 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.04 |
) |
|
$ |
0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share, diluted |
|
$ |
0.09 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.04 |
) |
|
$ |
0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
84
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(continued)
Our operating income included charges related to the ongoing U.S. government inquiries, for which
we recognized $1.7
million, $1.5 million, $1.5 million and $2.9 million during the first, second, third and
fourth quarters of 2008, respectively. In addition, our operating income during the second quarter
of 2008 included charges of $2.6 million related to an unfavorable appellate court decision and
$2.5 million of acquired in-process research and development costs related to our Inbone
acquisition. Net income in the first, second, third and fourth quarters of 2008 included the
after-tax effect of these amounts. Additionally, our fourth quarter net income included a $12.8
million charge for our valuation allowance, primarily for deferred tax
assets associated with French net
operating losses.
Our operating income for the fourth quarter of 2007 included a $3.3 million charge resulting from
an unfavorable ruling under binding arbitration. Our net income for the fourth quarter of 2007
included the after-tax effect of this amount plus $665,000 of interest.
85
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 to allow timely
decisions regarding required disclosure. 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,
2008. 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, 2008, 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, 2008, 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, 2008. Our internal control over financial reporting as of December 31, 2008, has been
audited by KPMG LLP, an independent registered public accounting firm, as stated in their report
which is included herein.
Changes in Internal Control Over Financial Reporting
During the three months ended December 31, 2008, there were no significant changes in our internal
control over financial reporting that materially affected, or that are reasonably likely to
materially affect, our internal control over financial reporting.
Item 9B. Other Information.
Not applicable.
86
PART III
Item 10. Directors, Executive Officers, and Corporate Governance.
The information required by this item is incorporated by reference from the definitive proxy
statement to be filed within 120 days after December 31, 2008, pursuant to Regulation 14A under the
Securities Exchange Act of 1934 in connection with the annual meeting of stockholders to be held on
May 13, 2009.
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, 2008, pursuant to Regulation 14A under the
Securities Exchange Act of 1934 in connection with the annual meeting of stockholders to be held on
May 13, 2009.
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, 2008, pursuant to Regulation 14A under the
Securities Exchange Act of 1934 in connection with the annual meeting of stockholders to be held on
May 13, 2009.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item is incorporated by reference from the definitive proxy
statement to be filed within 120 days after December 31, 2008, pursuant to Regulation 14A under the
Securities Exchange Act of 1934 in connection with the annual meeting of stockholders to be held on
May 13, 2009.
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, 2008, pursuant to Regulation 14A under the
Securities Exchange Act of 1934 in connection with the annual meeting of stockholders to be held on
May 13, 2009.
87
PART IV
Item 15. Exhibits and Financial Statement Schedules.
Financial Statements
See Index to Consolidated Financial Statements in Financial Statements and Supplementary Data.
Financial Statement Schedules
See
Schedule II Valuation and Qualifying Accounts on page S-1 of this report.
Index to Exhibits
|
|
|
Exhibit No. |
|
Description |
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. (2) |
|
|
|
3.2
|
|
Second Amended and Restated By-laws of Wright Medical Group, Inc. (3) |
|
|
|
4.1
|
|
Form of Common Stock certificate. (1) |
|
|
|
4.2
|
|
Indenture, dated as of November 26, 2007, between Wright Medical Group, Inc. and The Bank of New York as
trustee (including form of 2.625% Convertible Senior Notes due 2014). (4) |
|
|
|
4.3
|
|
Underwriting Agreement, dated as of November 19, 2007, among Wright Medical Group, Inc. and J.P. Morgan
Securities Inc., Piper Jaffray & Co. and Wachovia Capital Markets, LLC. (4) |
|
|
|
10.1
|
|
Credit Agreement dated as of June 30, 2006, among Wright Medical Group, Inc., its domestic subsidiaries,
the lenders named therein, Bank of America, N.A. and SunTrust Bank.,(5) as amended by First
Amendment to Credit Agreement dated as of November 16, 2007. (6) |
|
|
|
10.2
|
|
Fifth Amended and Restated 1999 Equity Incentive Plan (the 1999 Plan),(7) as amended by First
Amendment to the 1999 Plan. (8) |
|
|
|
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. (9) |
|
|
|
10.6*
|
|
Form of Non-Employee Director Stock Option Agreement pursuant to the 1999 Plan. (9) |
|
|
|
10.7*
|
|
Form of Executive Restricted Stock Grant Agreement pursuant to the 1999 Plan. (10) |
|
|
|
10.8*
|
|
Form of Non-Employee Director Restricted Stock Grant Agreement pursuant to the 1999 Plan. (10) |
|
|
|
10.9*
|
|
Wright Medical Group, Inc. Executive Performance Incentive Plan. (11) |
|
|
|
10.10*
|
|
Form of Indemnification Agreement between Wright Medical Group, Inc. and its directors and executive
officers. (1) |
|
|
|
10.11*
|
|
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc. and F. Barry
Bays,(12) as amended by Employment Agreement Amendment dated as of March 31,
2008.(13) |
|
|
|
10.12*
|
|
Employment Agreement dated as of November 22, 2005, between Wright Medical Technology, Inc. and John K.
Bakewell,(12) as amended by Employment Agreement Amendment dated as of March 31,
2008.(13) |
|
|
|
10.13*
|
|
Employment Agreement dated as of April 4, 2006, between Wright Medical Technology, Inc. and Gary D.
Henley. (14) |
|
|
|
10.14*
|
|
Employment Agreement dated as of March 1, 2007 between Wright Medical Netherlands B.V. and Paul R.
Kosters. (15) |
|
|
|
11
|
|
Computation of earnings per share (included in Note 12 of the Notes to Consolidated Financial Statements
in Financial Statements and Supplementary Data). |
|
|
|
12
|
|
Ratio of Earnings to Fixed Charges. |
|
|
|
14 |
|
Code of Ethics. (16) |
|
|
|
21
|
|
Subsidiaries of Wright Medical Group, Inc. (17) |
88
|
|
|
Exhibit No. |
|
Description |
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. |
|
|
|
(1) |
|
Incorporated by reference to our Registration Statement on Form S-1 (Registration No.
333-59732), as amended. |
|
(2) |
|
Incorporated by reference to our Registration Statement on Form S-8 filed on May 14, 2004. |
|
(3) |
|
Incorporated by reference to our current report on Form 8-K filed on February 19, 2008. |
|
(4) |
|
Incorporated by reference to our current report on Form 8-K filed on November 26, 2007. |
|
(5) |
|
Incorporated by reference to our current report on Form 8-K filed on July 7, 2006. |
|
(6) |
|
Incorporated by reference to our current report on Form 8-K filed on November 21, 2007. |
|
(7) |
|
Incorporated by reference to our definitive Proxy Statement filed on April 14, 2008. |
|
(8) |
|
Incorporated by reference to our quarterly report on Form 10-Q for the quarter ended September 30, 2008. |
|
(9) |
|
Incorporated by reference to our current report on Form 8-K filed on April 27, 2005. |
|
(10) |
|
Incorporated by reference to our Registration Statement on Form S-8 filed on June 18, 2008. |
|
(11) |
|
Incorporated by reference to our current report on Form 8-K filed on February 10, 2005. |
|
(12) |
|
Incorporated by reference to our current report on Form 8-K filed on November 22, 2005. |
|
(13) |
|
Incorporated by reference to our current report on Form 8-K filed on April 3, 2008, as amended by our current report on
Form 8-K/A filed on April 3, 2008. |
|
(14) |
|
Incorporated by reference to our current report on Form 8-K filed on March 22, 2006. |
|
(15) |
|
Incorporated by reference to our quarterly report on Form 10-Q filed on April 25, 2008. |
|
(16) |
|
Incorporated by reference to our current report on Form 8-K filed on March 31, 2004. |
|
(17) |
|
Incorporated by reference to our annual report on Form 10-K for the year ended December 31,
2006. |
* Denotes management contract or compensatory plan or arrangement.
89
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 23, 2009
|
|
|
|
|
|
Wright Medical Group, Inc.
|
|
|
By: |
/s/ Gary D. Henley
|
|
|
|
Gary D. Henley |
|
|
|
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 capacity and on the
dates indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ Gary D. Henley
Gary D. Henley
|
|
President, Chief Executive
Officer and Director
(Principal Executive
Officer)
|
|
February 23, 2009 |
|
|
|
|
|
/s/ John K. Bakewell
John K. Bakewell
|
|
Chief Financial Officer
(Principal Financial
Officer and Principal
Accounting Officer)
|
|
February 23, 2009 |
|
|
|
|
|
/s/ David D. Stevens
David D. Stevens
|
|
Chairman of the Board
|
|
February 23, 2009 |
|
|
|
|
|
/s/ Gary D. Blackford
Gary D. Blackford
|
|
Director
|
|
February 23, 2009 |
|
|
|
|
|
/s/ Martin J. Emerson
Martin J. Emerson
|
|
Director
|
|
February 23, 2009 |
|
|
|
|
|
/s/ Lawrence W. Hamilton
Lawrence W. Hamilton
|
|
Director
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|
February 23, 2009 |
|
|
|
|
|
/s/ John L. Miclot
John L. Miclot
|
|
Director
|
|
February 23, 2009 |
|
|
|
|
|
/s/ Amy S. Paul
Amy S. Paul
|
|
Director
|
|
February 23, 2009 |
|
|
|
|
|
/s/ Robert J. Quillinan
Robert J. Quillinan
|
|
Director
|
|
February 23, 2009 |
90
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Wright Medical Group, Inc.:
Under date of February 23, 2009, we reported on the consolidated balance sheets of Wright Medical
Group, Inc. and subsidiaries (the Company) as of December 31, 2008 and 2007, 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, 2008. These
consolidated financial statements, and our report thereon, are included in the annual report on
Form 10K for the year ended December 31, 2008. In connection with our audits of the
aforementioned consolidated financial statements, we also audited the related financial statement
schedule listed in Item 15 in the annual report on Form 10K. 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 audits.
In our opinion, the financial statement schedule, when considered in relation to the basic
consolidated financial statements taken as a whole, presents fairly, in all material respects,
the information set forth therein.
As discussed in Notes 2 and 11 to the consolidated financial statements, effective January 1, 2007,
the Company changed its method of accounting for uncertainty in income taxes as required by FASB
Interpretation No. 48, Accounting for Uncertainty in Income Taxes. Also as discussed in Note 2 to
the consolidated financial statements, the Company changed its method of quantifying errors in
2006.
(signed) KPMG LLP
Memphis, Tennessee
February 23, 2009
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, 2008 |
|
$ |
5,201 |
|
|
$ |
939 |
|
|
$ |
(2,133 |
) |
|
$ |
4,007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
$ |
2,850 |
|
|
$ |
2,339 |
|
|
$ |
12 |
|
|
$ |
5,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
$ |
1,997 |
|
|
$ |
820 |
|
|
$ |
33 |
|
|
$ |
2,850 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales returns and allowance: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
$ |
564 |
|
|
$ |
(74 |
) |
|
$ |
|
|
|
$ |
490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
$ |
350 |
|
|
$ |
214 |
|
|
$ |
|
|
|
$ |
564 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
$ |
434 |
|
|
$ |
(84 |
) |
|
$ |
|
|
|
$ |
350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
S-1