þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
DELAWARE (STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION) |
51-0317849 (I.R.S. EMPLOYER IDENTIFICATION NO.) |
|
311 ENTERPRISE DRIVE PLAINSBORO, NEW JERSEY (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) |
08536 (ZIP CODE) |
Title of Each Class | Name of Exchange on Which Registered | |
Common Stock, Par Value $.01 Per Share | The Nasdaq Stock Market LLC |
Large accelerated filer Yes þ No o | Accelerated filer Yes o No þ | Non-accelerated filer Yes o No þ |
PART I
ITEM 1. BUSINESS
OVERVIEW
The terms we, our, us, Company and Integra refer to Integra LifeSciences Holdings Corporation, a Delaware corporation, and its subsidiaries unless the context suggests otherwise.
Integra, a world leader in regenerative medicine, is dedicated to improving the quality of life for patients through the development, manufacturing and marketing of cost-effective surgical implants and medical instruments. Our products, used primarily in neurosurgery, extremity reconstruction, orthopedics and general surgery, are used to treat millions of patients every year. Revenues from these products grew to $419.3 million in 2006, an increase of 51% from $277.9 million in 2005.
Founded in 1989, Integra has grown to be a leader in applying the principles of biotechnology to medical devices, particularly for neurosurgery and extremity reconstruction, and is one of the largest surgical instrument companies in the United States. In the United States, Integra sells its products for neurosurgery and extremity reconstruction directly to customers and its surgical instruments through manufacturers representatives and stocking distributors. Outside the United States, Integra sells its products directly in major European markets and through stocking distributors elsewhere.
In 2006, we added approximately 75 new field-based representatives to our sales and marketing organizations in the United States and 10 in Europe. We now have approximately 400 sales and marketing employees, who sell our products in 120 countries.
STRATEGY
Our goal is to become the global leader in the development, manufacturing and marketing of medical devices, implants and instruments in neurosurgery and extremity reconstruction markets. Key elements of our strategy include:
Marketing innovative medical devices in underserved markets. We develop innovative medical devices for neurosurgery and reconstructive surgery. These are niche markets that larger medical device companies tend not to emphasize as their primary focus.
Investing in sales distribution channels to increase market penetration. We have built a large neurosurgical sales team of approximately 150 sales professionals in the United States who sell products to operating rooms and intensive care units. We have also built the largest direct extremity reconstruction sales force of approximately 75 sales professionals in the United States. Our European sales force consists of approximately 35 professionals.
Developing innovative products based on core technologies. We are a leader in regenerative technology. We sell a number of regenerative products through both our own sales network and alliances with other companies in private-label arrangements. Our proprietary highly purified collagen scaffold technology is the foundation of our products for duraplasty, dermal regeneration, nerve and tendon repair, and bone regeneration.
Acquiring products that fit existing sales channels or establish new sales channels. We acquire new products and businesses to increase the efficiency and size of our sales force, stimulate the development of new products, and extend the commercial lives of existing products. We have completed 11 acquisitions since the beginning of 2004, have demonstrated that we can quickly and profitably integrate new products and businesses, and have an active program to evaluate more such opportunities.
Our strategy allows us to expand our presence in hospitals and other health care facilities, to integrate acquired products effectively, to create strong sales platforms and to drive short- and long-term revenue and earnings growth.
SALES AND DISTRIBUTION
Our distribution channels include two direct sales organizations (Integra NeuroSciences and Integra Extremity Reconstruction), a network of dealers managed by our instrument sales organizations (Miltex and Jarit), and strategic alliances.
| Integra NeuroSciences. Integra NeuroSciences direct sales effort in the United States involves more than
150 professionals, including direct sales representatives, sales management and clinical educators who educate
and train our salespeople and customers in the use of our products. Direct sales representatives include
neurospecialists who focus on products used in operating rooms and intensive care units, intensive care unit
specialists devoted to products used in intensive care units, and spine specialists who sell products for
spine surgery. Integra NeuroSciences sales representatives call on neurosurgeons, intensivists, orthopedic
spine surgeons, other physicians, nurses, hospitals and surgery centers. Outside the United States, we sell
neurosurgical devices directly in Canada and major European markets and elsewhere through stocking
distributors. |
| Integra Extremity Reconstruction. Our Extremity Reconstruction sales organization in the United States
consists of more than 75 salespeople, sales managers and clinical educators. Extremity Reconstruction sells
medical devices to orthopedic surgeons, podiatric surgeons, trauma and reconstructive surgeons, burn surgeons
and other physicians who practice in hospitals and surgery centers. The Extremity Reconstruction team sells
both metal implants for internal fixation and joint reconstruction and regenerative biomaterials for the
repair of soft tissue, including the skin, peripheral nerves and tendons. Outside the United States, we sell
devices for extremity reconstruction directly through sales representatives in Canada and major European
markets and elsewhere through stocking distributors. |
| Jarit and Miltex Surgical Instruments. We are a leader in surgical instruments. Our Jarit and Miltex
organizations are the largest components of this business and together employ more than 60 sales
professionals, including sales management, instrument specialists and marketing managers. Jarit sells
hand-held surgical instruments to hospitals through manufacturers representatives. General surgeons,
neurosurgeons, orthopedic surgeons and cardiac surgeons use instruments sold by Jarit. We acquired Miltex in
2006. Miltex sells handheld surgical instruments in the alternate site market (outpatient surgical clinics,
physician offices, podiatry practices, dental offices and veterinary clinics) through a large network of
stocking distributors that includes both national wholesalers and local and regional dealers. |
| Strategic Alliances. We market certain products through strategic partners or original equipment
manufacturer customers. Because these products generally address large and diverse markets, it is more
cost-effective for us to leverage the product development and distribution systems of our strategic partners.
We have these relationships with Johnson & Johnson, Medtronic Sofamor Danek, Inc., Wyeth BioPharma and Zimmer
Holdings, Inc., among others. |
PRODUCTS OVERVIEW
Integra is a fully integrated medical device company with thousands of products for the medical specialties that we target. Our objective is to develop or otherwise provide any product that will improve our service to our customers. These products include both implants for neurosurgery, spinal surgery, and reconstructive surgery, and medical surgical equipment, which includes hand-held instruments, powered instruments, image-guided surgery systems, and monitors that measure brain parameters. We distinguish ourselves, however, by emphasizing the importance of the relatively new field of regenerative medicine.
In 2006, approximately 25% of our revenues came from surgical implants derived from our proprietary collagen matrix technology. While these products vary in composition and structure, they operate under similar principles. We build our matrix products from collagen, which is the basic structural protein that binds cells together in the body. Our matrices (whether for the dura mater, dermis, peripheral nerves, tendon or bone) provide a scaffold to support the infiltration of the patients own cells and the growth of blood vessels. Eventually, those infiltrating cells consume the collagen of the implanted matrix and lay down new native extracellular matrix. In their interaction with the patients body, our collagen matrices inhibit the formation of scar tissue, so in the end the implant disappears and healthy native tissue has taken its place. Because we can apply the basic technology to many different procedures, we sell regenerative medicine products through both our Integra NeuroSciences and Extremity Reconstruction organizations.
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NEUROSURGICAL PRODUCT PORTFOLIO
Implants For Neurosurgery And Spine
We offer a wide array of implants for neurosurgery and spine surgery, including a complete set of duraplasty products and biomaterials for spine surgery.
Duraplasty Products. In the United States, over 225,000 craniotomy procedures are performed each year. Most of these surgeries result in a breach of the dura mater the tough membrane that surrounds the brain and spinal chord - which breach must be repaired by suturing or the application of a dural graft. Since the introduction of the DuraGen® Dural Graft Matrix in 1999, we have become the market leader in dural grafts. These products are alternatives to autologous tissue grafts taken from elsewhere in the patients body.
Biomaterials for Spine. Over 300,000 patients undergo lumbar surgery in the United States each year, and adhesions a painful condition that occurs when internal scar tissue causes nerves, organs and other structures to adhere to each other are a frequent complication of the procedure. Our collagen matrix technology inhibits the formation of scar tissue, so we believe it is well-suited to address this problem. Outside the United States, we sell the DuraGen Plus® Adhesion Barrier Matrix as a barrier against the formation of adhesions following spine surgery and for the repair and restoration of the dura mater following spinal and cranial surgery. In the fourth quarter of 2006, the U.S. Food and Drug Administration (FDA) approved our Investigational Device Exemption (IDE) application to conduct a pivotal multi-center clinical trial designed to evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix for use in spinal surgery in the United States as a barrier against the formation of adhesions following such surgery. We enrolled the first patient in the trial in November 2006. If the trial is completed on schedule and achieves results acceptable to the FDA (of which there can be no assurance), we expect to launch the DuraGen Plus® Adhesion Barrier Matrix in the United States in 2010.
If the FDA approves the DuraGen Plus® matrix as an adhesion barrier, the commercial success of the product will hinge upon our ability to sell the product to orthopedic spine surgeons and neurosurgeons who perform spine procedures. To prepare for the launch of the adhesion barrier matrix in the United States, we are developing other regenerative medicine products for the spine and recruiting a sales organization that will specialize in selling them. The first of our new products is the Integra Mozaik Osteoconductive Scaffold, which we launched in February 2007. The Integra Mozaik scaffold is composed of highly purified type-I collagen and high purity tri-calcium phosphate. Together, these components, when mixed with bone marrow aspirate, form an environment conducive to the formation of bone. The Integra Mozaik scaffold will be available as a compression resistant strip and as putty, making it useful in a variety of spinal fusion procedures. We estimate that the global market for bone graft substitutes, excluding bone morphogenetic proteins, exceeds $350 million.
Medical Surgical Equipment For Neurosurgery
Integra NeuroSciences sells a full line of instruments and other equipment for neurosurgery. We have products for each step of cranial procedure and in the care of the patient after the operation. Integras Medical Surgical Equipment includes equipment used in the neurosurgery operating room (OR) and neurosurgery intensive care unit (ICU).
At the beginning of a craniotomy procedure, neurosurgeons deploy the market-leading MAYFIELD® line of cranial stabilization equipment to position and secure the patients head, an essential precondition to any cranial surgery. Once a patient is positioned properly, the surgeon then opens the skull, perhaps assisted by one of our disposable cranial access kits, and cuts through the dura mater. The surgeon might then use our specialty neurosurgery instruments to expose the tumor, perhaps guided to the precise location by a Radionics OmniSight® EXcel image-guided surgery system.
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Having located the tumor, the surgeon might then remove it with a CUSA Excel ultrasonic surgical aspirator, a powered instrument that selectively dissects tissue according to its density. The surgeon might reduce the bleeding at the point of removal with one of our collagen hemostatic agents. After removing the tumor, the surgeon can repair the dura mater with one of our duraplasty products and can fix the skull flap with our line of cranial plates and screws.
Following a craniotomy, the neurosurgery ICU monitors a patients post-operative condition. We offer the leading products for the monitoring of intracranial pressure (the Camino® ICP monitor) and metabolic activity (LICOX® metabolic monitoring system) and equipment for the drainage of excess cerebrospinal fluid (CSF) (the AccuDrain and Hermetic External Ventricular Drainage Systems). Our Mobius Multi Modality Monitoring System serves as an integrated hub for existing Integra monitoring systems such as the Camino® and LICOX® systems.
EXTREMITY RECONSTRUCTION PRODUCT PORTFOLIO
Extremity reconstruction is a growing segment of the orthopedic market. Traditionally, larger orthopedic medical device companies have not focused primarily on this niche market, thus making it attractive to us. We define extremity reconstruction to mean the repair of soft tissue and the orthopedic reconstruction of bone in the foot, ankle and leg below the knee and the hand, wrist, arm and shoulder.
Dermal Regeneration and Engineered Wound Dressings. Our dermal repair and regeneration products (Integra Bilayer Matrix Wound Dressing, Integra Matrix Wound Dressing, and Integra® Dermal Regeneration Template) are used to treat the chronic wounds that can form on the foot, ankle and lower leg, severe burns and scar contractures.
Integras matrix wound dressings are indicated for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, Post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. We estimate that the market opportunity for products used to treat trauma and chronic wounds is approximately $400 million.
Nerve and Tendon. Surgeons who specialize in foot or hand orthopedic surgery often have to repair nerves and tendon. We therefore offer the NeuraGen® Nerve Guide and the NeuraWrap Nerve Protector for peripheral nerve repair and protection and the TenoGlide Tendon Protector Sheet, all of which are based on our regenerative medicine technology platform.
The NeuraGen® Nerve Guide has been used in many procedures, including procedures to repair peripheral nerves in the upper and lower extremities and cranial and facial nerves, as well as procedures for brachial plexus reconstruction. We estimate that the worldwide market for the repair of severed peripheral nerves is approximately $40 million.
The NeuraWrap Nerve Protector, a collagen nerve repair conduit designed for the treatment of injured, compressed or scarred nerves, provides a protective environment for nerve healing, serving as an interface between damaged nerves and surrounding tissue. We estimate that the worldwide market for the repair of injured, compressed and scarred peripheral nerves is approximately $70 million.
The TenoGlide Tendon Protector Sheet is used to protect the repair of a tendon. Pre-clinical studies suggest that it may reduce the formation of scar tissue between the tendon and surrounding tissue and may preserve the gliding plane of the tendon. The TenoGlide Tendon Protector Sheet can be used in numerous procedures, such as the repair of the flexor and extensor tendons of the hand and the repair of the peronus brevis tendon of the foot.
Bone and Joint Fixation Devices and Instruments. We offer the extremity reconstruction surgeon with a complete set of bone and joint fixation devices for upper and lower extremity reconstruction.
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Through our Newdeal line, we have become a leading developer and manufacturer of specialty implants and instruments specifically designed for foot and ankle surgery. Newdeal products include a wide range of products for the forefoot, the midfoot and the hindfoot, including the Bold® Screw, Hallu®-Fix plate system and the HINTEGRA total ankle prosthesis. Customers for Newdeal products include orthopedic surgeons specializing in injuries of the foot, ankle and extremities, as well as podiatric surgeons, of which there are 3,200 and 2,400, respectively, in the United States. The current products address an approximately $500 million worldwide market.
In 2006, we acquired Kinetikos Medical, Inc. (KMI), a developer of specialty implants primarily for the hand and wrist. The acquisition made it much more efficient for our sales representatives to call on hand surgeons, who we expect will be a large market for our NeuraGen® and NeuraWrap products, and it strengthened our position as a developer and manufacturer of orthopedic implants and surgical devices for small bone and joint procedures involving the foot, ankle, hand, wrist and elbow. We now have products that address both the trauma and reconstructive segments of the extremities market.
These products include the Universal 2 Total Wrist System, which is recognized as the premier implant for wrist replacement, a procedure that restores the function of the arthritic wrist. The Subtarlar MBA® Implant System (Maxwell-Brancheau Arthroereisis System) is the market leading product that provides a simple and effective means of correcting debilitating flatfoot for both pediatric and adult patients.
In the reconstruction of lower extremities, our leading brands include Newdeal®, ICOS, the Bold® Cannulated Compression Screw, the Uni-Clip®, Hallu®-Fix System and the PANTA® Nail. For upper extremity reconstruction, we offer the Universal 2, Katalyst, Spider, Safeguard and Kompressor implant products.
RESEARCH AND DEVELOPMENT STRATEGY
Our research and development activities focus on identifying and evaluating unmet surgical needs and product improvement opportunities to drive the development of innovative solutions and products. We apply our technological and developmental core competencies to develop regenerative products for neurosurgical and reconstructive applications, neuro-monitoring and CSF management, cranial stabilization and closure, tissue ablation, surgical instruments and extremity small bone and joint fixation. Our activities include both internal product development initiatives and the acquisition of proprietary rights to strategic technological platforms.
Because implants represent a fast-growing, high-margin segment for us, a large portion of our research and development expenditure is allocated to the development of these products. Our regenerative product development portfolio focuses on applying our expertise in biomaterials and collagen matrices to support the development of innovative products targeted at neurosurgical, orthopedic and spinal surgery applications, as well as dermal regeneration, nerve repair, and wound dressing applications. Our focus on technological advancement, product segmentation and differentiation activities will continue to drive our activities in each of these areas. We are committed to investing in, and proving the safety and efficacy of, our regenerative products. Our initiation of the DuraGen Plus® Adhesion Barrier Matrix pivotal multi-center clinical trial in the United States reflects this commitment.
With the acquisition of Newdeal and KMI, we have quickly built a product development team focused on the development of fixation devices for extremity reconstruction. We have structured a robust new product development program that will advance our product offerings to both United States and European markets. This program includes the development of devices for both the upper and lower extremities.
Our research and development efforts in the medical surgical equipment arena primarily focus on neuro-monitoring applications and surgical systems. Our efforts in neuro-monitoring remain concentrated on the improvement of our existing advanced neuromonitors and the evaluation of new and innovative technologies that offer significant advancements in monitoring ability. The development of multimodality monitoring systems, such as the Mobius Multi Modality Monitoring System, facilitates the use of neuro-monitoring data and helps to drive utilization of our products in our neuron-monitoring product line. For CSF management, we are exploring opportunities for the improvement of long-standing product applications, and we are updating existing products to meet evolving needs. Our industry-leading cranial stabilization product expertise focuses on the advancement of mechanical stabilization techniques and the application of new materials to further the state-of-the-art of cranial stabilization. For tissue ablation, we will couple our existing development resources with those gained through the acquisition of Radionics to drive multi-technology based tissue ablation modalities to offer a broad array of products. Finally, we have an ongoing program of identifying, developing and commercializing powered and hand-held surgical instruments. Development of new hand-held instruments, however, does not result in significant research and development expenditures.
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We spent $14.1 million, $12.0 million and $26.0 million in 2004, 2005 and 2006, respectively, on research and development activities. The 2004 amount includes a $1.4 million milestone payment relating to the completion of certain development activities for an advanced neuro-monitoring system and a $0.5 million licensing fee paid for the development of a data acquisition system to support the integration of our advanced monitoring products. The 2005 amount includes a $0.5 million in-process research and development charge recorded in connection with an acquisition. The 2006 amount includes a $5.9 million in-process research and development charge recorded in connection with the KMI acquisition. Increases in research and development expenditures will accelerate the development of new devices for neurosurgery and extremity reconstruction. In addition to internal research and development activities, we may continue to acquire businesses that include research and development programs, which could result in additional in-process research and development charges in the future.
COMPETITION
Our largest competitors in the neurosurgery markets are the Medtronic Neurosurgery division of Medtronic, Inc., the Codman division of Johnson & Johnson, the Stryker Craniomaxillofacial division of Stryker Corporation and the Aesculap division of B. Braun. In addition, many of our neurosurgery product lines compete with smaller specialized companies or larger companies that do not otherwise focus on neurosurgery.
Our competition in extremity reconstruction includes the DePuy division of Johnson & Johnson, Synthes, Inc. and Stryker Corporation, as well as other major orthopedic companies that carry a full line of reconstructive surgery products. We also compete with Wright Medical Group in the orthopedic category.
We believe that we are the second largest reusable surgical instrument company in the United States. We compete with the largest reusable instrument company, V. Mueller, a division of Cardinal Healthcare, as well as the Aesculap division of B. Braun. In addition, we compete with the Codman division of Johnson & Johnson and many smaller instrument companies in the reusable and disposable specialty instruments markets. We rely on the depth and breadth of our sales and marketing organization and our procurement operation to maintain our competitive position in surgical instruments.
Our private-label products face diverse and broad competition, depending on the market addressed by the product.
Finally, in certain cases our products compete primarily against medical practices that treat a condition without using a medical device or any particular product, such as medical practices that use autograft tissue instead of our dermal regeneration products, duraplasty products and nerve repair products. Depending on the product line, we compete on the basis of our products features, strength of our sales force or marketing partner, sophistication of our technology and cost effectiveness of our solution to the customers medical requirements.
GOVERNMENT REGULATION
As a manufacturer and marketer of medical devices, we are subject to extensive regulation by the FDA and other federal governmental agencies and, in some jurisdictions, by state and foreign governmental authorities. These regulations govern the introduction of new medical devices, the observance of certain standards with respect to the design, manufacture, testing, labeling, promotion and sales of the devices, the maintenance of certain records, the ability to track devices, the reporting of potential product defects, the import and export of devices and other matters. We believe that we are in substantial compliance with these governmental regulations.
The regulatory process of obtaining product approvals and clearances can be onerous and costly. The FDA requires, as a condition to marketing a medical device in the United States, that we secure a Premarket Notification clearance pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act, an approved Premarket Approval (PMA) application (or supplemental PMA application) or an approved Product Development Protocol. Obtaining these approvals and clearances can take up to several years and involve preclinical studies and clinical testing. To perform clinical testing in the United States on an unapproved product, we are required to obtain an Investigational Device Exemption from the FDA. FDA rules may also require a filing for FDA approval prior to marketing products that are modifications of existing products or new indications for existing products. Moreover, after clearance is given, if the product is shown to be hazardous or defective, the FDA and foreign regulatory agencies have the power to withdraw the clearance or require us to change the device, its manufacturing process or its labeling, to supply additional proof of its safety and effectiveness or to recall, repair, replace or refund the cost of the medical device. Because we currently export medical devices manufactured in the United States that have not been approved by the FDA for distribution in the United States, we are required to provide notices to the FDA, maintain certain records relating to exports and make these records available to the FDA for inspection, if required.
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We are also required to register with the FDA as a device manufacturer. As such, we are subject to periodic inspection by the FDA for compliance with the FDAs Quality System Regulations. These regulations require that we manufacture our products and maintain our documents in a prescribed manner with respect to design, manufacturing, testing and control activities. Further, we are required to comply with various FDA requirements and other legal requirements for labeling and promotion. The Medical Device Reporting regulations require that we provide information to the FDA whenever there is evidence to reasonably suggest that one of our devices could have caused or contributed to a death or serious injury or, if a malfunction were to recur, could cause or contribute to a death or serious injury. Under FDA regulations, we are required to submit reports of certain voluntary recalls and corrections to the FDA. If the FDA believes that a company is not in compliance with applicable regulations, it may institute proceedings to detain or seize products, issue a warning letter, issue a recall order, impose operating restrictions, enjoin future violations and assess civil penalties against that company, its officers or its employees and may recommend criminal prosecution to the Department of Justice.
Medical device regulations also are in effect in many of the countries outside the United States in which we do business. These laws range from comprehensive device approval and quality system requirements for some or all of our medical device products to simpler requests for product data or certifications. The number and scope of these requirements are increasing. Under the European Union Medical Device Directive, all medical devices must meet the Medical Device Directive standards and receive CE Mark Certification. CE Mark Certification requires a comprehensive Quality System program, comprehensive technical documentation, data on the product, which a Notified Body in Europe reviews. The Medical Device Directive, ISO 9000 series and ISO 13485 are recognized international quality standards that are designed to ensure that we develop and manufacture quality medical devices. A recognized Notified Body (an organization designated by the national governments of the European Union member states to make independent judgments about whether or not a product complies with the protection requirements established by each CE marking directive) audits our facilities annually to verify our compliance with these standards. As a result of an amendment to Japans Pharmaceutical Affairs Law that went into effect on April 1, 2005, new regulations and requirements exist for obtaining approval of medical devices, including new requirements governing the conduct of clinical trials, the manufacturing of products and the distribution of products in Japan.
Certain countries, as well as the European Union, have issued regulations that govern products that contain materials derived from animal sources. Regulatory authorities are particularly concerned with materials infected with the agent that causes bovine spongiform encephalopathy, otherwise known as BSE or mad cow disease. These regulations affect our dermal regeneration products, duraplasty products, biomaterial products for the spine, nerve and tendon repair products and certain other products, all of which contain material derived from bovine tissue. Although we take great care to provide that our products are safe and free of agents that can cause disease, products that contain materials derived from animals, including our products, may become subject to additional regulation, or even be banned in certain countries, because of concern over the potential for prion transmission. Significant new regulation, or a ban of our products, could have a material adverse effect on our current business or our ability to expand our business. See Item 1A. Risk Factors Certain Of Our Products Contain Materials Derived From Animal Sources And May Become Subject To Additional Regulation.
We are subject to laws and regulations pertaining to healthcare fraud and abuse, including anti-kickback laws and physician self-referral laws, that regulate the means by which companies in the health care industry may market their products to hospitals and health care professionals and may compete by discounting the prices of their products. The delivery of our products is subject to regulation regarding reimbursement, and federal healthcare laws apply when a customer submits a claim for a product that is reimbursed under a federally-funded healthcare program. These rules require that we exercise care in structuring our sales and marketing practices and customer discount arrangements.
Our international operations subject us to laws regarding sanctioned countries, entities and persons, customs, import-export and other laws regarding transactions in foreign countries. Among other things, these laws restrict, and in some cases prohibit, United States companies from directly or indirectly selling goods, technology or services to people or entities in certain countries. In addition, these laws require that we exercise care in structuring our sales and marketing practices in foreign countries.
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Our research, development and manufacturing processes involve the controlled use of certain hazardous materials. We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these materials and certain waste products. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by the controlling laws and regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. In the event of this type of accident, we could be held liable for any damages that may result and any liability could exceed our resources. Although we believe that we are in compliance in all material respects with applicable environmental laws and regulations, we could incur significant costs to comply with environmental laws and regulations in the future, and our operations, business or assets could be materially adversely affected by current or future environmental laws or regulations.
In addition to the above regulations, we are and may be subject to regulation under federal and state laws, including, but not limited to, requirements regarding occupational health and safety, laboratory practices and the maintenance of personal health information. As a public company, we are subject to the securities laws and regulations, including the Sarbanes-Oxley Act of 2002. We also are subject to other present, and could be subject to possible future, local, state, federal and foreign regulations.
PATENTS AND INTELLECTUAL PROPERTY
We seek patent protection of our key technology, products and product improvements, both in the United States and in selected foreign countries. When determined appropriate, we have enforced and plan to continue to enforce and defend our patent rights. In general, however, we do not rely on our patent estate to provide us with any significant competitive advantages as it relates to our existing product lines. We rely upon trade secrets and continuing technological innovations to develop and maintain our competitive position. In an effort to protect our trade secrets, we have a policy of requiring our employees, consultants and advisors to execute proprietary information and invention assignment agreements upon commencement of employment or consulting relationships with us. These agreements provide that all confidential information developed or made known to the individual during the course of their relationship with us must be kept confidential, except in specified circumstances.
AccuDrain, Bold®, Camino®, CRW®, CUSA®, CUSA Excel, Dissectron®, DuraGen®, DuraGen Plus®, Hallu®-Fix, HINTEGRA, ICOS, Integra®, Integra Dermal Regeneration Template®, Integra LifeSciences Corporation®, Integra Mozaik, Integra NeuroSciences®, Jarit®, LICOX®, Miltex®, Mobius, NeuraGen®, NeuraWrap, NewDeal®, OmniSight®, Radionics®, Selector®, Sublartar MBA®, TenoGlide, Uniclip® and XKnife are some of the material trademarks of Integra LifeSciences Corporation and its subsidiaries. MAYFIELD® is a registered trademark of SM USA, Inc., a wholly owned subsidiary of Schaerer Mayfield USA, Inc., and is used by Integra under a license.
EMPLOYEES
At December 31, 2006, we had approximately 1,750 employees engaged in production and production support (including warehouse, engineering and facilities personnel), quality assurance/quality control, research and development, regulatory and clinical affairs, sales, marketing, administration and finance. Except for certain employees at our facilities in France, none of our employees is subject to a collective bargaining agreement.
FINANCIAL INFORMATION ABOUT GEOGRAPHIC AREAS
Financial information about our geographical areas is set forth in our financial statements under Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations International Revenues and Operations and Note 15 Segment and Geographic Information to our Consolidated Financial Statements.
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SOURCES OF RAW MATERIALS
In general, raw materials essential to our businesses are readily available from multiple sources. For reasons of quality assurance, sole source availability, or cost effectiveness, certain components and raw materials are available only from a sole supplier. Our policy is to maintain sufficient inventory of components so that our production will not be significantly disrupted even if a particular component or material is not available for a period of time.
Certain of our products, including our dermal regeneration products, duraplasty products, biomaterial products for the spine, nerve and tendon repair products and certain other products, contain material derived from bovine tissue. We take great care to provide that our products are safe and free of agents that can cause disease. In particular, the collagen used in the products that Integra manufactures is derived only from the deep flexor tendon of cattle less than 24 months old from New Zealand, a country that has never had a case of bovine spongiform encephalopathy, or from the United States. The collagen used in a product that we sell, but do not manufacture, is derived from bovine pericardium. We are also qualifying sources of collagen from other countries that are considered BSE-free. The World Health Organization classifies different types of cattle tissue for relative risk of BSE transmission. Deep flexor tendon and bovine pericardium are in the lowest-risk categories for BSE transmission (the same category as milk, for example), and are therefore considered to have a negligible risk of containing the agent that causes BSE.
SEASONALITY
Revenues during our second and fourth quarters tend to be stronger than the first and third quarters. This is because many hospitals increase their purchases of our products during the second and fourth quarters, which coincides with the end of their budget cycle.
AVAILABLE INFORMATION
We are subject to the informational requirements of the Securities Exchange Act of 1934. In accordance with the Exchange Act, we file annual, quarterly and special reports, proxy statements and other information with the Securities and Exchange Commission. You may view our financial information, including the information contained in this report, and other reports we file with the Securities and Exchange Commission, on the Internet, without charge as soon as reasonably practicable after we file them with the Securities and Exchange Commission, in the SEC Filings page of the Investor Relations section of our website at www.Integra-LS.com. You may also obtain a copy of any of these reports, without charge, from our investor relations department, 311 Enterprise Drive, Plainsboro, NJ 08536. Alternatively, you may view or obtain reports filed with the Securities and Exchange Commission at the SEC Public Reference Room at 100 F Street, N.E. in Washington, D.C. 20549, or at the Securities and Exchange Commissions Internet site at www.sec.gov. Please call the Securities and Exchange Commission at 1-800-SEC-0330 for further information on the operation of the public reference facilities.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We have made statements in this report, including statements under Business and Managements Discussion and Analysis of Financial Condition and Results of Operations that constitute 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. These forward-looking statements are subject to a number of risks, uncertainties and assumptions about us including, among other things:
| general economic and business conditions, both nationally and in our international markets; |
| our expectations and estimates concerning future financial performance, financing plans and the impact of
competition; |
| anticipated trends in our business; |
| existing and future regulations affecting our business; |
| our ability to obtain additional debt and equity financing to fund capital expenditures and working capital
requirements and acquisitions; |
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| physicians willingness to adopt our recently launched and planned products, third-party payors
willingness to provide reimbursement for these products and our ability to secure regulatory approval for
products in development; |
| initiatives launched by our competitors; |
| our ability to protect our intellectual property, including trade secrets; |
| our ability to complete acquisitions, integrate operations post-acquisition and maintain relationships with
customers of acquired entities; |
| work stoppages at our facilities; and |
| other risk factors described in the section entitled Risk Factors in this report. |
You can identify these forward-looking statements by forward-looking words such as believe, may, could, might, will, estimate, continue, anticipate, intend, seek, plan, expect, should, would and similar expressions in this report. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
ITEM 1A. RISK FACTORS
Our Operating Results May Fluctuate.
Our operating results, including components of operating results, such as gross margin cost of product sales, may fluctuate from time to time, and such fluctuations could affect our stock price. Our operating results have fluctuated in the past and can be expected to fluctuate from time to time in the future. Some of the factors that may cause these fluctuations include:
| the impact of acquisitions; |
| the impact of our restructuring activities; |
| the timing of significant customer orders; |
| market acceptance of our existing products, as well as products in development; |
| the timing of regulatory approvals; |
| changes in the rates of exchange between the U.S. dollar and other currencies of foreign countries in which
we do business, such as the euro and the British pound; |
| expenses incurred and business lost in connection with product field corrections or recalls; |
| increases in the cost of raw materials, including energy and steel; |
| our ability to manufacture our products efficiently; and |
| the timing of our research and development expenditures. |
The Industry And Market Segments in Which We Operate Are Highly Competitive, And We May Be Unable To Compete Effectively With Other Companies.
In general, there is intense competition among medical device companies. We compete with established medical technology companies in many of our product areas. Competition also comes from early-stage companies that have alternative technological solutions for our primary clinical targets, as well as universities, research institutions and other non-profit entities. Many of our competitors have access to greater financial, technical, research and development, marketing, manufacturing, sales, distribution services and other resources than we do. Our competitors may be more effective at implementing their technologies to develop commercial products. Our competitors may be able to gain market share by offering lower-cost products or by offering products that enjoy better reimbursement methodologies from third-party payors, such as Medicare.
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Our competitive position will depend on our ability to achieve market acceptance for our products, develop new products, implement production and marketing plans, secure regulatory approval for products under development, obtain reimbursement under Medicare, Medicaid and private healthcare insurers and obtain patent protection. We may need to develop new applications for our products to remain competitive. Technological advances by one or more of our current or future competitors could render our present or future products obsolete or uneconomical. Our future success will depend upon our ability to compete effectively against current technology as well as to respond effectively to technological advances. Competitive pressures could adversely affect our profitability. For example, two of our largest competitors introduced an onlay dural graft matrix during 2004, another large company introduced a duraplasty product in 2006 and others may be preparing to introduce similar products. Competitors have also been developing products to compete with our extremity reconstruction implants. The introduction and market acceptance of such products could reduce the sales, growth in sales and profitability of our duraplasty products.
Our largest competitors in the neurosurgery markets are the Medtronic Neurosurgery division of Medtronic, Inc., the Codman division of Johnson & Johnson, the Stryker Craniomaxillofacial division of Stryker Corporation and the Aesculap division of B. Braun Medical Inc. In addition, many of our neurosurgery product lines compete with smaller specialized companies or larger companies that do not otherwise focus on neurosurgery. Our competitors in extremity reconstruction include the DePuy division of Johnson & Johnson, Synthes, Inc. and Stryker Corporation, as well as other major orthopedic companies that carry a full line of reconstructive products. We also compete with Wright Medical Group, Inc. in the orthopedic category. In surgical instruments, we compete with V. Mueller, a division of Cardinal Healthcare, as well as the Aesculap division of B. Braun. In addition, we compete with the Codman division of Johnson & Johnson and many smaller instrument companies in the reusable and disposable specialty instruments markets. Our private-label products face diverse and broad competition, depending on the market addressed by the product. Finally, in certain cases our products compete primarily against medical practices that treat a condition without using a device or any particular product, such as the medical practices that use autograft tissue instead of our dermal regeneration products, duraplasty products and nerve repair products.
Our Current Strategy Involves Growth Through Acquisitions, Which Requires Us To Incur Substantial Costs And Potential Liabilities For Which We May Never Realize The Anticipated Benefits.
In addition to internal growth, our current strategy involves growth through acquisitions. Since the beginning of 2004, we have acquired 11 businesses or product lines at a total cost of approximately $315 million.
We may be unable to continue to implement our growth strategy, and our strategy ultimately may be unsuccessful. A significant portion of our growth in revenues has resulted from, and is expected to continue to result from, the acquisition of businesses complementary to our own. We engage in evaluations of potential acquisitions and are in various stages of discussion regarding possible acquisitions, certain of which, if consummated, could be significant to us. Any new acquisition can result in material transaction expenses, increased interest and amortization expense, increased depreciation expense and increased operating expense, any of which could have a material adverse effect on our operating results. Certain businesses that we acquire may not have adequate financial, regulatory or quality controls at the time we acquire them. As we grow by acquisition, we must manage and integrate the new businesses to bring them into our systems for financial, regulatory and quality control, realize economies of scale, and control costs. In addition, acquisitions involve other risks, including diversion of management resources otherwise available for ongoing development of our business and risks associated with entering new markets in which our marketing and sales force has limited experience or where experienced distribution alliances are not available. Our future profitability will depend in part upon our ability to develop further our resources to adapt to these new products or business areas and to identify and enter into satisfactory distribution networks. We may not be able to identify suitable acquisition candidates in the future, obtain acceptable financing or consummate any future acquisitions. If we cannot integrate acquired operations, manage the cost of providing our products or price our products appropriately, our profitability could suffer. In addition, as a result of our acquisitions of other healthcare businesses, we may be subject to the risk of unanticipated business uncertainties, regulatory matters or legal liabilities relating to those acquired businesses for which the sellers of the acquired businesses may not indemnify us or for which the indemnification may not be sufficient to cover the ultimate liabilities.
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To Market Our Products Under Development We Will First Need To Obtain Regulatory Approval. Further, If We Fail To Comply With The Extensive Governmental Regulations That Affect Our Business, We Could Be Subject To Penalties And Could Be Precluded From Marketing Our Products.
As a manufacturer and marketer of medical devices, we are subject to extensive regulation by the FDA and other federal governmental agencies and, in some jurisdictions, by state and foreign governmental authorities. These regulations govern the introduction of new medical devices, the observance of certain standards with respect to the design, manufacture, testing, labeling, promotion and sales of the devices, the maintenance of certain records, the ability to track devices, the reporting of potential product defects, the import and export of devices and other matters.
Our products under development are subject to FDA approval or clearance prior to marketing for commercial use. The process of obtaining necessary FDA approvals or clearances can take years and is expensive and uncertain. Our inability to obtain required regulatory approval on a timely or acceptable basis could harm our business. Further, approval or clearance may place substantial restrictions on the indications for which the product may be marketed or to whom it may be marketed, warnings that may be required to accompany the product or additional restrictions placed on the sale and/or use of the product. Further studies, including clinical trials and FDA approvals, may be required to gain approval for the use of a product for clinical indications other than those for which the product was initially approved or cleared or for significant changes to the product. These studies could take years to complete and could be expensive, and there is no guarantee that the results will convince the FDA to approve or clear the additional indication. In addition, for products with an approved Pre-Marketing Approval (PMA), the FDA requires annual reports and may require post-approval surveillance programs to monitor the products safety and effectiveness. Results of post-approval programs may limit or expand the further marketing of the product.
Another risk of application to the FDA relates to the regulatory classification of new products or proposed new uses for existing products. In the filing of each application, we make a judgment about the appropriate form and content of the application. If the FDA disagrees with our judgment in any particular case and, for example, requires us to file a PMA application rather than allowing us to market for approved uses while we seek broader approvals or requires extensive additional clinical data, the time and expense required to obtain the required approval might be significantly increased or approval might not be granted.
Approved products are subject to continuing FDA requirements relating to quality control and quality assurance, maintenance of records, reporting of adverse events and product recalls, documentation, and labeling and promotion of medical devices.
The FDA and foreign regulatory authorities require that our products be manufactured according to rigorous standards. These regulatory requirements could significantly increase our production or purchasing costs and could even prevent us from making or obtaining our products in amounts sufficient to meet market demand. If we or a third-party manufacturer change our approved manufacturing process, the FDA may require a new approval before that process may be used. Failure to develop our manufacturing capability could mean that even if we were to develop promising new products, we might not be able to produce them profitably, as a result of delays and additional capital investment costs. Manufacturing facilities, both international and domestic, are also subject to inspections by or under the authority of the FDA. In addition, failure to comply with applicable regulatory requirements could subject us to enforcement action, including product seizures, recalls, withdrawal of clearances or approvals, restrictions on or injunctions against marketing our product or products based on our technology, cessation of operations and civil and criminal penalties.
We are also subject to the regulatory requirements of countries outside the United States where we do business. For example, under the European Union Medical Device Directive, all medical devices must meet the Medical Device Directive standards and receive CE Mark Certification. CE Mark Certification requires a comprehensive Quality System program, comprehensive technical documentation and data on the product, which a Notified Body in Europe reviews. As a result of an amendment to Japans Pharmaceutical Affairs Law that went into effect on April 1, 2005, new regulations and requirements exist for obtaining approval of medical devices, including new requirements governing the conduct of clinical trials, the manufacturing of products and the distribution of products in Japan. Significant resources may be needed to comply with the extensive auditing of and requests for documentation relating to all manufacturing facilities of our company and our vendors by the Pharmaceutical Medical Device Agency and the Ministry of Health, Labor and Welfare in Japan to comply with the amendment to the Pharmaceutical Affairs Law. These new regulations may affect our ability to obtain approvals of new products for sale in Japan.
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Certain Of Our Products Contain Materials Derived From Animal Sources And May Become Subject To Additional Regulation.
Certain of our products, including our dermal regeneration products, duraplasty products, biomaterial products for the spine, nerve and tendon repair products and certain other products, contain material derived from bovine tissue. Products that contain materials derived from animal sources, including food, pharmaceuticals and medical devices, are increasingly subject to scrutiny in the media and by regulatory authorities. Regulatory authorities are concerned about the potential for the transmission of disease from animals to humans via those materials. This public scrutiny has been particularly acute in Japan and Western Europe with respect to products derived from animal sources, because of concern that materials infected with the agent that causes bovine spongiform encephalopathy, otherwise known as BSE or mad cow disease, may, if ingested or implanted, cause a variant of the human Creutzfeldt-Jakob Disease, an ultimately fatal disease with no known cure. Cases of BSE in cattle discovered in Canada and the United States have increased awareness of the issue in North America.
We take great care to provide that our products are safe and free of agents that can cause disease. In particular, the collagen used in the products that we manufacture is derived only from the deep flexor tendon of cattle less than 24 months old from New Zealand, a country that has never had a case of BSE, or from the United States. The collagen used in a product that we sell, but do not manufacture, is derived from bovine pericardium. We are also qualifying sources of collagen from other countries that are considered BSE-free. The World Health Organization classifies different types of cattle tissue for relative risk of BSE transmission. Deep flexor tendon and bovine pericardium are in the lowest-risk categories for BSE transmission (the same category as milk, for example), and are therefore considered to have a negligible risk of containing the agent that causes BSE (an improperly folded protein known as a prion). Nevertheless, products that contain materials derived from animals, including our products, may become subject to additional regulation, or even be banned in certain countries, because of concern over the potential for prion transmission. Significant new regulation, or a ban of our products, could have a material adverse effect on our current business or our ability to expand our business.
Certain countries, such as China, Taiwan and Argentina, have issued regulations that require our collagen products be processed from bovine tendon sourced from countries where no cases of BSE have occurred, and the European Union has requested that our dural replacement products be sourced from bovine tendon sourced from a country where no cases of BSE have occurred. In addition, Japan has issued new regulations regarding medical devices that contain tissue of animal origin. Among other regulations, Japan requires that the tendon used in the manufacture of medical devices sold in Japan originate in a country that has never had a case of BSE. Currently, we purchase our tendon from the United States and New Zealand. We received approval in Japan for the use of New Zealand-sourced tendon in the manufacturing of our products sold in Japan. If we cannot continue to use or qualify a source of tendon from New Zealand or another country that has never had a case of BSE, we will not be permitted to sell our collagen hemostatic agents and products for oral surgery in Japan. We do not currently sell our dural or dermal repair products in Japan.
Lack Of Market Acceptance For Our Products Or Market Preference For Technologies That Compete With Our Products Could Reduce Our Revenues And Profitability.
We cannot be certain that our current products or any other products that we may develop or market will achieve or maintain market acceptance. Certain of the medical indications that can be treated by our devices can also be treated by other medical devices or by medical practices that do not include a device. The medical community widely accepts many alternative treatments, and certain of these other treatments have a long history of use. For example, the use of autograft tissue is a well-established means for repairing the dermis, and it competes for acceptance in the market with the Integra® Dermal Regeneration Template.
We cannot be certain that our devices and procedures will be able to replace those established treatments or that either physicians or the medical community in general will accept and utilize our devices or any other medical products that we may develop.
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In addition, our future success depends, in part, on our ability to develop additional products. Even if we determine that a product candidate has medical benefits, the cost of commercializing that product candidate could be too high to justify development. Competitors could develop products that are more effective, achieve more favorable reimbursement status from third-party payors, cost less or are ready for commercial introduction before our products. If we are unable to develop additional commercially viable products, our future prospects could be adversely affected.
Market acceptance of our products depends on many factors, including our ability to convince prospective collaborators and customers that our technology is an attractive alternative to other technologies, to manufacture products in sufficient quantities and at acceptable costs, and to supply and service sufficient quantities of our products directly or through our distribution alliances. In addition, unfavorable reimbursement methodologies, or adverse determinations of third-party payors against our products or third-party determinations that favor a competitors product over ours, could harm acceptance or continued use of our products. The industry is subject to rapid and continuous change arising from, among other things, consolidation and technological improvements. One or more of these factors may vary unpredictably, and such variations could have a material adverse effect on our competitive position. We may not be able to adjust our contemplated plan of development to meet changing market demands.
Our Intellectual Property Rights May Not Provide Meaningful Commercial Protection For Our Products, Potentially Enabling Third Parties To Use Our Technology Or Very Similar Technology And Could Reduce Our Ability To Compete In The Market.
To compete effectively, we depend in part, on our ability to maintain the proprietary nature of our technologies and manufacturing processes, which includes the ability to obtain, protect and enforce patents on our technology and to protect our trade secrets. We own or have licensed patents that cover aspects of some of our product lines. However, our patents may not provide us with any significant competitive advantage. Others may challenge our patents and, as a result, our patents could be narrowed, invalidated or rendered unenforceable. Competitors may develop products similar to ours that our patents do not cover. In addition, our current and future patent applications may not result in the issuance of patents in the United States or foreign countries. Further, there is a substantial backlog of patent applications at the U.S. Patent and Trademark Office, and the approval or rejection of patent applications usually takes approximately two and a half years.
Our Competitive Position Depends, In Part, Upon Unpatented Trade Secrets Which We May Be Unable To Protect.
Our competitive position also depends upon unpatented trade secrets, which are difficult to protect. We cannot assure you that others will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets, that our trade secrets will not be disclosed or that we can effectively protect our rights to unpatented trade secrets.
In an effort to protect our trade secrets, we require our employees, consultants and advisors to execute proprietary information and invention assignment agreements upon commencement of employment or consulting relationships with us. These agreements provide that, except in specified circumstances, all confidential information developed or made known to the individual during the course of their relationship with us must be kept confidential. We cannot assure you, however, that these agreements will provide meaningful protection for our trade secrets or other proprietary information in the event of the unauthorized use or disclosure of confidential information.
Our Success Will Depend Partly On Our Ability To Operate Without Infringing Or Misappropriating The Proprietary Rights Of Others.
We may be sued for infringing the intellectual property rights of others. In addition, we may find it necessary, if threatened, to initiate a lawsuit seeking a declaration from a court that we do not infringe the proprietary rights of others or that their rights are invalid or unenforceable. If we do not prevail in any litigation, in addition to any damages we might have to pay, we would be required to stop the infringing activity or obtain a license for the proprietary rights involved. Any required license may be unavailable to us on acceptable terms, or at all. In addition, some licenses may be nonexclusive and allow our competitors to access the same technology we license.
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If we fail to obtain a required license or are unable to design our product so as not to infringe on the proprietary rights of others, we may be unable to sell some of our products, and this potential inability could have a material adverse effect on our revenues and profitability.
We May Be Involved In Lawsuits Relating To Our Intellectual Property Rights And Promotional Practices, Which May Be Expensive.
To protect or enforce our intellectual property rights, we may have to initiate or defend legal proceedings, such as infringement suits or interference proceedings, against or by third parties. For example, Codman & Shurtleff, Inc., a division of Johnson & Johnson, commenced an action in May 2006 seeking declaratory relief that its DURAFORM product does not infringe our patent covering our duraplasty products and that our patent is invalid and unenforceable. In addition, we may have to institute proceedings regarding our competitors promotional practices or defend proceedings regarding our promotional practices. Litigation is costly, and, even if we prevail, the cost of that litigation could affect our profitability. In addition, litigation is time consuming and could divert management attention and resources away from our business. We may also provoke these third parties to assert claims against us.
It May Be Difficult To Replace Some Of Our Suppliers.
Outside vendors, some of whom are sole-source suppliers, provide key components and raw materials used in the manufacture of our products. Although we believe that alternative sources for many of these components and raw materials are available, any supply interruption in a limited or sole source component or raw material could harm our ability to manufacture our products until a new or alternative source of supply is identified and qualified. In addition, an uncorrected defect or suppliers variation in a component or raw material, either unknown to us or incompatible with our manufacturing process, could harm our ability to manufacture products. We may not be able to find a sufficient alternative supplier in a reasonable time period, or on commercially reasonable terms, if at all, and our ability to produce and supply our products could be impaired. We believe that these factors are most likely to affect the following products that we manufacture:
| our collagen-based products, such as the Integra® Dermal Regeneration Template and wound dressing products,
the DuraGen® family of products, and our Absorbable Collagen Sponges; |
| our products made from silicone, such as our neurosurgical shunts and drainage systems and hemodynamic
shunts; and |
| products which use many different electronic parts from numerous suppliers, such as our intracranial
monitors and catheters. |
If we were suddenly unable to purchase products from one or more of these companies, we would need a significant period of time to qualify a replacement, and the production of any affected products could be disrupted. While it is our policy to maintain sufficient inventory of components so that our production will not be significantly disrupted even if a particular component or material is not available for a period of time, we remain at risk that we will not be able to qualify new components or materials quickly enough to prevent a disruption if one or more of our suppliers ceases production of important components or materials.
If Any Of Our Manufacturing Facilities Were Damaged And/Or Our Manufacturing Or Business Processes Interrupted, We Could Experience Lost Revenues And Our Business Could Be Seriously Harmed.
We manufacture our products in a limited number of facilities. Damage to our manufacturing, development or research facilities due to fire, natural disaster, power loss, communications failure, unauthorized entry or other events could cause us to cease development and manufacturing of some or all of our products. In particular, our San Diego, California facility is susceptible to earthquake damage, wildfire damage and power losses from electrical shortages as are other businesses in the Southern California area. Our Anasco, Puerto Rico plant, where we manufacture collagen, silicone and our private-label products, is vulnerable to hurricane, storm and wind damage. Although we maintain property damage and business interruption insurance coverage on these facilities, our insurance might not cover all losses under such circumstances and we may not be able to renew or obtain such insurance in the future on acceptable terms with adequate coverage or at reasonable costs.
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In addition, we began implementing an enterprise business system in 2004, which we intend to use in our facilities. This system, the hosting and maintenance of which we outsource, replaces several systems on which we previously relied and will be implemented in several stages. We have outsourced our product distribution function in the United States and in Europe. A delay or other problem with the enterprise business system problems or with our outsourced distribution functions could have a material adverse effect on our operations.
We Are Exposed To A Variety Of Risks Relating To Our International Sales And Operations, Including Fluctuations In Exchange Rates, Local Economic Conditions And Delays In Collection Of Accounts Receivable.
We generate significant revenues outside the United States in euros, British pounds and in U.S. dollar-denominated transactions conducted with customers who generate revenue in currencies other than the U.S. dollar. For those foreign customers who purchase our products in U.S. dollars, currency fluctuations between the U.S. dollar and the currencies in which those customers do business may have an impact on the demand for our products in foreign countries where the U.S. dollar has increased in value compared to the local currency.
Because we have operations based in Europe and we generate revenues and incur operating expenses in euros and British pounds, we experience currency exchange risk with respect to those foreign currency-denominated revenues and expenses. We also experience currency exchange risk with respect to the yen.
Currently, we do not use derivative financial instruments to manage operating foreign currency risk. As the volume of our business transacted in foreign currencies increases, we expect to continue to assess the potential effects that changes in foreign currency exchange rates could have on our business. If we believe that this potential impact presents a significant risk to our business, we may enter into derivative financial instruments to mitigate this risk.
In general, we cannot predict the consolidated effects of exchange rate fluctuations upon our future operating results because of the number of currencies involved, the variability of currency exposure and the potential volatility of currency exchange rates.
Our international operations subject us to customs, import-export, sanctioned country and foreign corrupt practices laws. These laws restrict, and in some cases prohibit, United States companies from directly or indirectly selling goods, technology or services to people or entities in certain countries. These laws also prohibit transactions with certain designated persons.
Local economic conditions, legal, regulatory or political considerations, the effectiveness of our sales representatives and distributors, local competition and changes in local medical practice could also affect our sales to foreign markets. Relationships with customers and effective terms of sale frequently vary by country, often with longer-term receivables than are typical in the United States.
Changes In The Healthcare Industry May Require Us To Decrease The Selling Price For Our Products Or May Reduce The Size Of The Market For Our Products, Either Of Which Could Have A Negative Impact On Our Financial Performance.
Trends toward managed care, healthcare cost containment and other changes in government and private sector initiatives in the United States and other countries in which we do business are placing increased emphasis on the delivery of more cost-effective medical therapies that could adversely affect the sale and/or the prices of our products. For example:
| major third-party payors of hospital services and hospital outpatient services, including Medicare,
Medicaid and private healthcare insurers, annually revise their payment methodologies, which can result in
stricter standards for reimbursement of hospital charges for certain medical procedures; |
| Medicare, Medicaid and private healthcare insurer cutbacks could create downward price pressure on our
products; |
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| recently effected local Medicare coverage determinations will eliminate reimbursement for certain of our
matrix wound dressing products in certain regions, negatively affecting our market for these products, and
future determinations could eliminate reimbursement for certain of our products; |
| potential legislative proposals have been considered that would result in major reforms in the U.S.
healthcare system that could have an adverse effect on our business; |
| there has been a consolidation among healthcare facilities and purchasers of medical devices in the United
States who prefer to limit the number of suppliers from whom they purchase medical products, and these
entities may decide to stop purchasing our products or demand discounts on our prices; |
| we are party to contracts with group purchasing organizations, which negotiate pricing for many member
hospitals, that require us to discount our prices for certain of our products and limit our ability to raise
prices for certain of our products, particularly surgical instruments; |
| there is economic pressure to contain healthcare costs in domestic and international markets; |
| there are proposed and existing laws, regulations and industry policies in domestic and international
markets regulating the sales and marketing practices and the pricing and profitability of companies in the
healthcare industry; |
| proposed laws or regulations that will permit hospitals to provide financial incentives to doctors for
reducing hospital costs (known as gainsharing) and to award physician efficiency (known as physician
profiling) could reduce prices; and |
| there have been initiatives by third-party payors to challenge the prices charged for medical products that
could affect our ability to sell products on a competitive basis. |
Both the pressures to reduce prices for our products in response to these trends and the decrease in the size of the market as a result of these trends could adversely affect our levels of revenues and profitability of sales.
Regulatory Oversight Of The Medical Device Industry Might Affect The Manner In Which We May Sell Medical Devices.
There are laws and regulations that govern the means by which companies in the healthcare industry may market their products to healthcare professionals and may compete by discounting the prices of their products. Although we exercise care in structuring our sales and marketing practices and customer discount arrangements to comply with those laws and regulations, we cannot assure you that:
| government officials charged with responsibility for enforcing those laws will not assert that our sales
and marketing practices or customer discount arrangements are in violation of those laws or regulations; or |
| government regulators or courts will interpret those laws or regulations in a manner consistent with our
interpretation. |
In January 2004, ADVAMED, the principal U.S. trade association for the medical device industry, put in place a model code of conduct that sets forth standards by which its members should abide in the promotion of their products. We have in place policies and procedures for compliance that we believe are at least as stringent as those set forth in the ADVAMED Code, and we provide routine training to our sales and marketing personnel on our policies regarding sales and marketing practices. Nevertheless, the sales and marketing practices of our industry have been the subject of increased scrutiny from government agencies, and we believe that this trend will continue.
Our Private-Label Business Depends Significantly On Key Relationships With Third Parties, Which We Could Be Unable To Establish And Maintain.
Our private-label business depends in part on our entering into and maintaining collaborative or alliance agreements with third parties concerning product marketing, as well as research and development programs. Our most important alliance is our agreement with the Wyeth BioPharma division of Wyeth for the development of collagen matrices to be used in conjunction with Wyeth BioPharmas recombinant bone protein, a protein that stimulates the growth of bone in humans. The third parties with whom we have entered into agreements might terminate these agreements for a variety of reasons, including developing other sources for the product that we supply. Termination of any of our alliances would require us to develop other means to distribute the affected products and could adversely affect our expectations for the growth of private-label products.
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We May Have Significant Product Liability Exposure And Our Insurance May Not Cover All Potential Claims.
We are exposed to product liability and other claims in the event that our technologies or products are alleged to have caused harm. We may not be able to obtain insurance for the potential liability on acceptable terms with adequate coverage or at reasonable costs. Any potential product liability claims could exceed the amount of our insurance coverage or may be excluded from coverage under the terms of the policy. Our insurance may not be renewed at a cost and level of coverage comparable to that then in effect.
We Are Subject To Regulatory Requirements Relating To The Use Of Hazardous Substances Which May Impose Significant Compliance Costs On Us.
Our research, development and manufacturing processes involve the controlled use of certain hazardous materials. We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these materials and certain waste products. Although we believe that our safety procedures for handling and disposing of those materials comply with the standards prescribed by the applicable laws and regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. In the event of such an accident, we could be held liable for any damages that result and any related liability could exceed the limits or fall outside the coverage of our insurance and could exceed our resources. We may not be able to maintain insurance on acceptable terms or at all.
The Loss Of Key Personnel Could Harm Our Business.
We believe our success depends on the contributions of a number of our key personnel, including Stuart M. Essig, our President and Chief Executive Officer. If we lose the services of key personnel, those losses could materially harm our business. We maintain key person life insurance on Mr. Essig and two other members of management.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
Our principal executive offices are located in Plainsboro, New Jersey. Principal manufacturing and research facilities are located in New Jersey, Massachusetts, Ohio, California, Pennsylvania, Puerto Rico, England, Ireland and France. Our instrument procurement operations are located in Germany. Our primary distribution centers are located in Nevada, New York, Pennsylvania and Belgium. In addition, we lease several smaller facilities to support additional administrative, assembly, and distribution operations. Third parties own and operate the facilities in Nevada and Belgium. We lease all of our facilities other than our facilities in Pennsylvania, England, and Biot, France, which we own.
All of our manufacturing facilities (other than one outside of the United States) are registered with the FDA. Our facilities are subject to FDA inspection to assure compliance with Quality System Regulations. We believe that our manufacturing facilities are in substantial compliance with Quality System Regulations, suitable for their intended purposes and have capacities adequate for current and projected needs for existing products. Some capacity of the plants is being converted, with any needed modification, to meet the current and projected requirements of existing and future products.
ITEM 3. LEGAL PROCEEDINGS
Various lawsuits, claims and proceedings are pending or have been settled by us. The most significant of those are described below.
In May 2006, Codman & Shurtleff, Inc., a division of Johnson & Johnson, commenced an action in the United States District Court for the District of New Jersey for declaratory judgment against Integra LifeSciences Corporation with respect to United States Patent No. 5,997,895 (the 895 Patent) held by Integra. Integras patent covers dural repair technology related to Integras DuraGen® family of duraplasty products.
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The action seeks declaratory relief that Codmans DURAFORM product does not infringe Integras patent and that Integras patent is invalid and unenforceable. Codman does not seek either damages from Integra or injunctive relief to prevent Integra from selling the DuraGen® Dural Graft Matrix. Integra has filed a counterclaim against Codman, alleging that Codmans DURAFORM product infringes the 895 Patent, seeking injunctive relief preventing the sale and use of DURAFORM, and seeking damages, including treble damages, for past infringement.
In July 1996, Integra sued Merck KGaA, a German corporation, seeking damages for patent infringement. The patents in question are part of a group of patents granted to The Burnham Institute and licensed by Integra that are based on the interaction between a family of cell surface proteins called integrins and the arginine-glycine-aspartic acid (RGD) peptide sequence found in many extracellular matrix proteins.
The case has been tried, appealed and returned to the trial court. In September 2004, the trial court ordered Merck KGaA to pay Integra $6.4 million in damages. Merck KGaA filed a petition for a writ of certiorari with the United States Supreme Court seeking review of the Circuit Courts decision, and the Supreme Court granted the writ in January 2005.
On June 13, 2005, the Supreme Court vacated the June 2003 judgment of the Circuit Court. The Supreme Court held that the Circuit Court applied an erroneous interpretation of 35 U.S.C. §271(e)(1) when it rejected the challenge of Merck KGaA to the jurys finding that Merck KGaA failed to show that its activities were exempt from claims of patent infringement under that statute. On remand, the Circuit Court was to have reviewed the evidence under a reasonableness test that does not provide categorical exclusions of certain types of activities. The hearing before the Circuit Court occurred in June 2006, and a ruling is expected in 2007. Further enforcement of the trial courts order has been stayed. We have not recorded any gain in connection with this matter, pending final resolution and completion of the appeals process.
In addition to these matters, we are subject to various claims, lawsuits and proceedings in the ordinary course of our business, including claims by current or former employees, distributors and competitors and with respect to our products. In the opinion of management, such claims are either adequately covered by insurance or otherwise indemnified, or are not expected, individually or in the aggregate, to result in a material adverse effect on our financial condition. However, it is possible that our results of operations, financial position and cash flows in a particular period could be materially affected by these contingencies or the costs related thereto.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of security holders during the fourth quarter of the fiscal year covered by this report.
ADDITIONAL INFORMATION
The following information is furnished in this Part I pursuant to Instruction 3 to Item 401(b) of Regulation S-K.
Executive Officers of the Company
Our executive officers are appointed annually and serve at the discretion of the Board of Directors. The following information indicates the position and age of our executive officers as of the date of this report and their previous business experience.
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NAME | AGE | POSITION | ||||
Stuart M. Essig
|
45 | President, Chief Executive Officer and Director | ||||
Maureen B. Bellantoni
|
57 | Executive Vice President and Chief Financial Officer | ||||
Gerard S. Carlozzi
|
51 | Executive Vice President and Chief Operating Officer | ||||
John B. Henneman, III
|
45 | Executive Vice President and Chief Administrative Officer | ||||
Judith E. OGrady
|
56 | Senior Vice President, Regulatory, Quality Assurance and Clinical Affairs | ||||
Jerry E. Corbin
|
47 | Vice President and Corporate Controller |
Stuart M. Essig is Integras President and Chief Executive Officer and a director. He joined Integra in December 1997. Before joining Integra, Mr. Essig supervised the medical technology practice at Goldman, Sachs & Co. as a managing director. Mr. Essig had ten years of broad health care experience at Goldman Sachs serving as a senior merger and acquisitions advisor to a broad range of domestic and international medical technology, pharmaceutical and biotechnology clients. Mr. Essig also serves on the Board of Directors of St. Jude Medical Corporation, Zimmer Holdings, Inc. and ADVAMED, the Advanced Medical Technology Association. Mr. Essig received an A.B. degree from the Woodrow Wilson School of Public and International Affairs at Princeton University and an M.B.A. and a Ph.D. degree in Financial Economics from the University of Chicago, Graduate School of Business.
Maureen B. Bellantoni is Integras Executive Vice President and Chief Financial Officer, and is responsible for the companys finance department, including the corporate controller, financial reporting, budgeting, internal audit, tax, logistics, customer service and treasury functions of the Company. Ms. Bellantoni joined Integra in January 2006. Ms. Bellantoni served as Senior Vice President and Chief Financial Officer of CP Kelco, a global leader in the hydrocolloids market from 2003 through its sale to J.M. Huber in October 2004. From 2000 to 2002, Ms. Bellantoni served as Chief Financial Officer North America and Senior Vice President of Finance of Burger King. During 1999 to 2000, she served as Executive Vice President Finance, for Rohn Industries Inc. a publicly traded telecommunications company. From 1993 to 1998, she served at Sara Lee Corporation as President and Chief Operating Officer for their Bil Mar Foods division, Vice President, Finance and Chief Financial Officer for Sara Lee Meats, and Vice President, Finance and Chief Financial Officer for PYA/Monarch, Inc. From 1985 to 1993, Ms. Bellantoni was with Emerson Electric Company, as Vice President, Finance and Chief Financial Officer for their Automatic Switch Division and Vice President, Far East and Vice President, Finance and Chief Financial Officer for the Branson Ultrasonics Corporation. Ms. Bellantoni received a B.S. degree from the University of Bridgeport and an M.B.A. from the University of Connecticut.
Gerard S. Carlozzi is Integras Executive Vice President and Chief Operating Officer, and is responsible for the Companys marketing, sales, manufacturing, information technology and research and development functions. Mr. Carlozzi joined Integra in September 2003, after serving as a consultant to the Company from March 2003 to September 2003. Prior to joining Integra, Mr. Carlozzi had spent over 25 years in the medical device industry. From 1999 to 2003, he was President, Chief Executive Officer and a director of Bionx Implants, a company focused on the development of novel biomaterial devices for various surgical specialties. Prior to 1999, he held various management positions with Synthes USA, Acufex microsurgical and Infusaid Corporation. Mr. Carlozzi also serves on the Board of Directors of Cascade Medical Corporation and Scandius Biomedical, Inc., privately held companies. Mr. Carlozzi received a B.S. degree and an M.B.A. from Northeastern University.
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John B. Henneman, III is Integras Executive Vice President and Chief Administrative Officer, and is responsible for regulatory affairs, corporate quality systems, clinical affairs, clinical education, business development, human resources, the law department, investor relations and Miltex. Mr. Henneman was our General Counsel from September 1998 until September 2000 and our Senior Vice President, Chief Administrative Officer and Secretary from September 2000 until February 2003. Prior to joining Integra in August 1998, Mr. Henneman served Neuromedical Systems, Inc., a public company developer and manufacturer of in vitro diagnostic equipment, in various capacities for more than four years. Mr. Henneman received an A.B. degree from Princeton University and a J.D. from the University of Michigan Law School.
Judith E. OGrady is Integras Senior Vice President of Regulatory Affairs, Quality Assurance and Clinical Affairs. Ms. OGrady joined Integra in 1985. Ms. OGrady has worked in the areas of medical devices and collagen technology for over 20 years. Prior to joining Integra, Ms. OGrady worked for Colla-Tec, Inc., a Marion Merrell Dow Company. During her career she has held positions with Surgikos, a Johnson & Johnson Company, and was on the faculty of Boston University College of Nursing and Medical School. Ms. OGrady led the team that obtained the FDA approval for Integra® Dermal Regeneration Template, the first regenerative product approved by the FDA, and has led teams responsible for approvals of the Companys other regenerative product lines as well as more than 500 FDA and international submissions. Ms. OGrady received a B.S. degree from Marquette University and M.S.N. in Nursing from Boston University.
Jerry E. Corbin is Integras Vice President and Corporate Controller. Mr. Corbin joined Integra in June 2006. Prior to joining Integra, Mr. Corbin held key finance positions in corporate accounting, sales and marketing and, most recently, research and development for sanofi-aventis and its predecessors from 1989 to 2006. Prior to that, he held management positions with Sigma-Aldrich Corporation and Edward D. Jones & Company. Mr. Corbin received a B.S. degree from Illinois State University and is a certified public accountant.
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PART II
ITEM 5. MARKET FOR REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information, Holders and Dividends
Our common stock trades on The Nasdaq Global Market under the symbol IART. The following table lists the high and low sales prices for our common stock for each quarter for the last two years:
HIGH | LOW | HIGH | LOW | |||||||||||||
2006 | 2005 | |||||||||||||||
Fourth Quarter |
$ | 43.57 | $ | 36.36 | $ | 38.89 | $ | 32.00 | ||||||||
Third Quarter |
$ | 39.51 | $ | 34.56 | $ | 38.26 | $ | 28.74 | ||||||||
Second Quarter |
$ | 42.90 | $ | 36.27 | $ | 37.31 | $ | 28.69 | ||||||||
First Quarter |
$ | 41.72 | $ | 35.00 | $ | 39.87 | $ | 34.75 |
We have not paid any cash dividends on our common stock since our formation. Our credit facility limits the amount of dividends that we may pay. See Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources Requirements and Capital Resources. Any future determinations to pay cash dividends on the common stock will be at the discretion of our Board of Directors and will depend upon our results of operations and financial condition and other factors deemed relevant by the Board of Directors.
The number of stockholders of record as of February 23, 2007 was approximately 850, which includes stockholders whose shares were held in nominee name.
Issuer Purchases of Equity Securities
In February 2006, our Board of Directors adopted a stock repurchase program that authorized us to repurchase shares of our common stock for an aggregate purchase price not to exceed $50 million through December 31, 2006. Shares may be purchased either in the open market or in privately negotiated transactions. We purchased 456,750 and 400,900 shares of our common stock for a total purchase price of approximately $16.7 million and $15.1 million during the three months ended September 30, 2006 and June 30, 2006, respectively under this repurchase program. No purchases were made under this program during the first quarter of 2006.
In October 2006, our Board of Directors terminated the repurchase program approved in February 2006 and adopted a new program that authorized us to repurchase shares of our common stock for an aggregate purchase price not to exceed $75 million through December 31, 2007. Shares may be repurchased either in the open market or in privately negotiated transactions.
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The following table summarizes our repurchases of our common stock during the quarter ended December 31, 2006 under the October 2006 repurchase program:
Approximate Dollar | ||||||||||||||||
Total Number of | Value of Shares | |||||||||||||||
Shares Purchased as | that May Yet be | |||||||||||||||
Total Number of | Average Price Paid | Part of Publicly | Purchased Under the | |||||||||||||
Shares Purchased | per Share | Announced Program | Program | |||||||||||||
October 1, 2006 October 31, 2006 |
| | | $ | 75,000,000 | |||||||||||
November 1, 2006 November 30, 2006 |
460,855 | $ | 40.88 | 460,855 | 56,161,030 | |||||||||||
December 1, 2006 December 31, 2006 |
461,771 | (1) | 42.10 | 459,750 | 36,807,629 | |||||||||||
Total |
922,626 | $ | 41.49 | 920,605 | $ | 36,807,629 | ||||||||||
(1) | Includes 2,021 shares withheld by us from an employee to satisfy tax withholding obligations upon the vesting of
restricted stock issued to the employee. |
ITEM 6. SELECTED FINANCIAL DATA
The information set forth below should be read in conjunction with Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations and our consolidated financial statements and related notes included elsewhere in this report. We have acquired numerous businesses and product lines during the previous five years. As a result of these acquisitions, the consolidated financial results and balance sheet data for certain of the periods presented below may not be directly comparable.
Years Ended December 31, | ||||||||||||||||||||
2006 | 2005 | 2004 | 2003 | 2002 | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||||
Operating Results: |
||||||||||||||||||||
Total revenues, net (1) |
$ | 419,297 | $ | 277,935 | $ | 229,825 | $ | 185,599 | $ | 117,822 | ||||||||||
Costs and expenses (2) |
360,553 | 221,830 | 205,046 | 145,952 | 98,635 | |||||||||||||||
Operating income |
58,744 | 56,105 | 24,779 | 39,647 | 19,187 | |||||||||||||||
Interest income (expense), net |
(8,426 | ) | (265 | ) | 555 | 471 | 3,535 | |||||||||||||
Other income (expense),
net (3) |
(2,010 | ) | (739 | ) | 2,674 | 3,071 | 3 | |||||||||||||
Income before income taxes |
48,308 | 55,101 | 28,008 | 43,189 | 22,725 | |||||||||||||||
Provision for income taxes (4) |
18,901 | 17,907 | 10,811 | 16,328 | (12,552 | ) | ||||||||||||||
Net income |
$ | 29,407 | $ | 37,194 | $ | 17,197 | $ | 26,861 | $ | 35,277 | ||||||||||
Diluted net income per share |
$ | 0.97 | $ | 1.15 | $ | 0.55 | $ | 0.86 | $ | 1.14 | ||||||||||
Weighted average shares
outstanding |
32,747 | 34,565 | 31,102 | 33,104 | 30,720 |
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December 31, | ||||||||||||||||||||
2006 | 2005 | 2004 | 2003 | 2002 | ||||||||||||||||
(in thousands) | ||||||||||||||||||||
Financial Position: |
||||||||||||||||||||
Cash, cash
equivalents, and
marketable
securities (5) |
$ | 22,697 | $ | 143,384 | $ | 195,982 | $ | 206,743 | $ | 132,311 | ||||||||||
Total assets |
613,618 | 448,432 | 456,713 | 412,526 | 274,668 | |||||||||||||||
Long-term debt (5) |
508 | 118,378 | 118,900 | 119,427 | | |||||||||||||||
Retained earnings /
(accumulated
deficit) |
66,336 | 36,929 | (265 | ) | (17,462 | ) | (44,323 | ) | ||||||||||||
Stockholders equity |
296,162 | 289,818 | 307,823 | 268,530 | 247,597 |
(1) | In 2003, we recorded $11.0 million of other revenue related to the acceleration of the recognition of unused
minimum purchase payments and deferred license fee revenue from ETHICON, Inc., a division of Johnson & Johnson,
following the termination of the supply distribution and collaboration agreement with ETHICON in December 2003. |
(2) | In 2004, we recorded $23.9 million in share-based compensation charges incurred in connection with the extension
of the employment agreement of our President and Chief Executive Officer. |
(3) | In 2004, we recorded a $1.4 million gain in other income related to an unrealized gain on a foreign currency
collar which was used to reduce our exposure to fluctuations in the exchange rate between the euro and the US
dollar as a result of our commitment to acquire Newdeal Technologies SAS for 38.5 million euros. The collar
contract expired on January 3, 2005, concurrent with our acquisition of Newdeal Technologies. In 2003, we
recorded a $2.0 million gain in other income (expense) associated with a termination payment received from
ETHICON. |
(4) | In 2002, we recognized a deferred income tax benefit of $20.4 million primarily related to the reduction of a
portion of the valuation allowance recorded against our deferred tax assets. |
(5) | In 2003, we issued $120.0 million of 2.5% contingent convertible subordinated notes due 2008. The net proceeds
generated by the notes, after expenses, were $115.9 million. The notes that remain outstanding are convertible
into approximately 3.5 million shares of our common stock. In 2006, we exchanged $119.5 million of these notes
for the equivalent amount of new notes. Because the closing price of our stock at the issuance date was higher
than the market price trigger of the new notes, the new notes were classified as a current liability. In 2006,
all marketable securities were liquidated. |
ITEM 7. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read together with the selected consolidated financial data and our financial statements and the related notes appearing elsewhere in this report. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those under the heading Risk Factors.
Regulation G, Conditions for Use of Non-GAAP Financial Measures, and other provisions of the Securities Exchange Act of 1934, as amended, define and prescribe the conditions for the use of certain non-GAAP financial information. In Managements Discussion and Analysis of Financial Condition and Results of Operations, we provide information regarding growth in revenues excluding recently acquired product lines, which is a non-GAAP financial measure. A reconciliation of this non-GAAP financial measure to the most comparable GAAP measure is provided in this annual report.
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This non-GAAP financial measure should not be relied upon to the exclusion of GAAP financial measures. Management believes that this non-GAAP financial measure constitutes important supplemental information to investors which reflects an additional way of viewing aspects of our operations that, when viewed with our GAAP results and the accompanying reconciliations, provides a more complete understanding of factors and trends affecting our ongoing business and operations. Management strongly encourages investors to review our financial statements and publicly filed reports in their entirety and to not rely on any single financial measure. Because non-GAAP financial measures are not standardized, it may not be possible to compare these financial measures with other companies non-GAAP financial measures having the same or similar names.
GENERAL
Integra, a world leader in regenerative medicine, is dedicated to improving the quality of life for patients through the development, manufacturing and marketing of cost-effective surgical implants and medical instruments. Our products, used primarily in neurosurgery, extremity reconstruction, orthopedics and general surgery, are used to treat millions of patients every year.
Our distribution channels include two direct sales organizations (Integra NeuroSciences and Integra Reconstructive Surgery), a network managed by a direct sales organization (Jarit/Miltex Surgical Instruments) and strategic alliances. We have direct sales forces in the United States. Outside of the United States, we sell our products directly through sales representatives in major European markets and through stocking distributors elsewhere. We invest substantial resources and management effort to develop our sales organizations, and we believe that we compete very effectively in this aspect of our business.
In 2006, we revised the manner in which we present our revenues. This change better aligns our product categories by functional product characteristic and intended use. We now present revenues in two categories: Neurosurgical and Orthopedic Implants and Medical Surgical Equipment. Our Neurosurgical and Orthopedic Implants product group includes the following: dural grafts that are indicated for the repair of the dural matter; dermal regeneration and engineered wound dressings; implants used in small bone and joint fixation, repair of peripheral nerves; hydrocephalus management; and implants used in bone regeneration and in guided tissue regeneration in periodontal surgery. Our Medical Surgical Equipment product group includes the following: ultrasonic surgery systems for tissue ablation; cranial stabilization and brain retraction systems; instrumentation used in general, neurosurgical, spinal, plastic and reconstructive surgery and dental procedures; systems for the measurement of various brain parameters; and devices used to gain access to the cranial cavity and to drain excess cerebrospinal fluid from the ventricle of the brain.
We manage these product groups and distribution channels on a centralized basis. Accordingly, we report our financial results under a single operating segment the development, manufacture and distribution of medical devices.
We manufacture many of our products in various plants located in the United States, Puerto Rico, France, Germany, Ireland and the United Kingdom. We also source most of our hand-held surgical instruments through specialized third-party vendors.
We believe that we have a particular advantage in the development, manufacture and sale of specialty tissue repair products derived from bovine collagen. Products that contain materials derived from animal sources, including food, pharmaceuticals and medical devices, are increasingly subject to scrutiny from the media and regulatory authorities. These products comprised 25%, 31% and 31% of revenues in the years ended December 31, 2006, 2005 and 2004, respectively. Accordingly, widespread public controversy concerning collagen products, new regulations, or a ban of our products containing material derived from bovine tissue, could have a material adverse effect on our current business and our ability to expand.
Our objective is to continue to build a customer-focused and profitable medical device company by developing or acquiring innovative medical devices and other products to sell through our sales channels. Our strategy therefore entails substantial growth in revenues through both internal means through launching new and innovative products and selling existing products more intensively and by acquiring existing businesses or already successful product lines.
25
We aim to achieve this growth in revenues while maintaining strong financial results. While we pay attention to any meaningful trend in our financial results, we pay particular attention to measurements that are indicative of long-term profitable growth. These measurements include revenue growth (derived through acquisitions and products developed internally), gross margins on total revenues, operating margins (which we aim to continually expand on as we leverage our existing infrastructure) and earnings per fully diluted share of common stock.
ACQUISITIONS
Our strategy for growing our business includes the acquisition of complementary product lines and companies. Our recent acquisitions of businesses, assets and product lines may make our financial results for the year ended December 31, 2006 not directly comparable to those of the corresponding prior year periods. See Note 3 to the financial statements for a further discussion. From January 2004 through December 2006, we have acquired the following businesses, assets and product lines:
On July 31, 2006 we acquired all of the outstanding shares of Kinetikos Medical, Inc. (KMI) for $39.5 million in cash, subject to certain adjustments. There are additional contingent future payments totaling up to $20 million based on the performance of the KMI business after the acquisition. KMI, based in Carlsbad, California, was a leading developer and manufacturer of innovative orthopedic implants and surgical devices for small bone and joint procedures involving the foot, ankle, hand, wrist and elbow. KMI marketed products that addressed both the trauma and reconstructive segments of the extremities market. KMIs reconstructive products are largely focused on treating deformities and arthritis in small joints of the upper and lower extremity, while its trauma products are focused on the treatment of fractures of small bones most commonly found in the extremities. KMI is considered a strategic fit for the growing extremity business and should strengthen our presence in the orthopedic hand market. We have integrated the KMI product line into our U.S. Extremity Reconstruction sales force and plan to increase sales of KMI product internationally through our well-established Newdeal infrastructure.
On July 6, 2006, we acquired a direct sales force in Canada through the acquisition of our longstanding distributor, Canada Microsurgical Ltd. (Canada Microsurgical). Canada Microsurgical has eight sales representatives who cover all of the provinces in Canada. The sales and distribution operations are expected to enhance our expanding Canadian business. We paid $5.8 million (6.4 million Canadian dollars) for Canada Microsurgical at closing and $0.1 million of transaction related costs. In addition, we may pay additional contingent future payments up to an additional $1.9 million (2.1 million Canadian dollars) over the next three years, depending on the performance of the business.
On May 12, 2006, we acquired all of the outstanding capital stock of Miltex Holdings, Inc. (Miltex) for $102.7 million in cash paid at closing, subject to certain adjustments, and $0.6 million of transaction related costs. Miltex, based in York, Pennsylvania, is a leading provider of surgical and dental hand instruments to alternate site facilities, which includes physician and dental offices and ambulatory surgery care sectors. Miltex sells products under the Miltex®, Meisterhand®, Vantage®, Moyco®, Union Borach® and Thompson trademarks in over 65 countries, using a network of independent distributors. Miltex operates a manufacturing and distribution facility in York, Pennsylvania and also operates a leased facility in Tuttlingen, Germany, where Miltexs staff coordinates design, production and delivery of instruments. Miltex is considered a strategic fit for our instrument business. Miltex also provides a broader platform to grow the business as it participates in the dental and veterinary markets.
On March 3, 2006, we acquired the assets of the Radionics Division of Tyco Healthcare Group, L.P. for approximately $74.5 million in cash, subject to certain adjustments, and $3.2 million of acquisition related expenses in a transaction treated as a business combination. Radionics, based in Burlington, Massachusetts, is a leader in the design, manufacture and sale of advanced minimally invasive medical instruments in the fields of neurosurgery and radiation therapy. Radionics products include the CUSA Excel ultrasonic surgical aspiration system, the CRW® stereotactic system, the XKnife stereotactic radiosurgery system, and the OmniSight® EXcel image guided surgery system. This acquisition increases our global neurosurgery product offering, positions us to offer new stereotactic surgery products, and secures our entry into the radiosurgery/radiotherapy and image-guided surgery device business.
26
In September 2005, we acquired the intellectual property estate of Eunoe, Inc. for $0.5 million in cash. Prior to ceasing operations, Eunoe, Inc. was engaged in the development of its innovative COGNIShunt® system for the treatment of Alzheimers disease patients. The acquired intellectual property has not been developed into a product that has been approved or cleared by the FDA and has no future alternative use other than in clinical applications involving the regulation of cerebrospinal fluid. Accordingly, we recorded the entire acquisition price as an in-process research and development charge in 2005.
In January 2005, we acquired all of the outstanding capital stock of Newdeal Technologies SAS. We paid $51.9 million (38.3 million euros) in cash at closing, a $0.7 million working capital adjustment paid in January 2006 and $0.8 million of acquisition related expenses. Additionally, we paid the sellers an additional $1.6 million (1.3 million euros) in January 2006 as a result of their continued employment with us through January 3, 2006. This additional payment was accrued to selling, general and administrative expense on a straight-line basis in 2005 over the one-year employment requirement period.
Newdeal is a leading developer and marketer of specialty implants and instruments specifically designed for foot and ankle surgery. Newdeals products include a wide range of products for the forefoot, the midfoot and the hindfoot, including the Bold® Screw, Hallu®-Fix plate system and the HINTEGRA total ankle prosthesis. Newdeals target physicians include orthopedic surgeons specializing in injuries of the foot, ankle and extremities, as well as podiatric surgeons.
In May 2004, we acquired the MAYFIELD® Cranial Stabilization and Positioning Systems and the BUDDE® Halo Retractor System business from Schaerer Mayfield USA, Inc. (formerly Ohio Medical Instrument Company) for $20.0 million in cash paid at closing, a $0.3 million working capital adjustment and $0.3 million of acquisition related expenses. The MAYFIELD® and BUDDE® lines include skull clamps, headrests, reusable and disposable skull pins, blades, retractor systems and spinal implants. MAYFIELD® systems are the market leader in the United States, and neurosurgeons have used them for over thirty years. The products are sold in the United States through our Integra NeuroSciences direct sales organization and in international markets through distributors.
In May 2004, we acquired all of the capital stock of Berchtold Medizin-Elektronik GmbH, now named Integra ME GmbH, from Berchtold Holding GmbH for $5.0 million in cash. Integra ME manufactured and sold the ELEKTROTOM® line of electrosurgery generators and the SONOTOM ultrasonic surgical aspirator, as well as a broad line of related handpieces, instruments and disposables used in many surgical procedures, including neurosurgery. We closed the Integra ME production facility at the end of 2005 and integrated the manufacturing and distribution of the products into other Integra operations.
In January 2004, we acquired two small instruments businesses: the R&B instrument business of R&B Surgical Solutions, LLC for $2.0 million in cash and the Sparta disposable critical care devices and surgical instruments business from Fleetwood Medical, Inc. for $1.6 million in cash. The R&B instrument line is a complete line of high-quality handheld surgical instruments used in neuro- and spinal surgery. The Sparta product line includes products used in plastic and reconstructive, ear, nose and throat (ENT), neuro, ophthalmic and general surgery.
RESTRUCTURING ACTIVITIES
In June 2005, we announced plans to restructure certain of our European operations. The restructuring plan included closing our Integra ME production facility in Tuttlingen, Germany and reducing various positions in our production facility located in Biot, France, both of which were substantially completed in December 2005. We transitioned the manufacturing operations of Integra ME to our production facility in Andover, United Kingdom. We also eliminated some duplicative sales and marketing positions, primarily in Europe. We terminated 68 employees under the European restructuring plan.
In 2005, we also completed the transfer of the Spinal Specialties assembly operations from our San Antonio, Texas plant to our San Diego, California plant and we continue to transfer certain assembly, processing and packaging operations to our San Diego and Puerto Rico facilities. During the year ended December 31, 2006, we terminated four employees in connection with the transfer of certain manufacturing packaging operations from our plant in Plainsboro, New Jersey to our plant in Anasco, Puerto Rico.
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In October 2006, we announced plans to further restructure our French sales and marketing organization. One plan includes the elimination of nine positions at our Biot, France facility. Another plan includes the closing of our facility in Nantes, France and the elimination of three positions. These activities will be transferred to the sales and marketing headquarters in Lyon, France and should be completed in 2007.
In connection with these restructuring activities, we recorded employee termination costs of $1.0 and $4.0 million in 2006 and 2005, respectively, for the estimated costs of employee termination benefits to be provided to the affected employees and related facility exit costs.
While we expect a positive impact from the restructuring and integration activities, such results remain uncertain. We have reinvested most of the savings from these restructuring and integration activities in further expanding our European sales, marketing and distribution organization and integrating the Radionics, KMI and Newdeal businesses into our existing sales and distribution networks.
RESULTS OF OPERATIONS
Net income in 2006 was $29.4 million, or $0.97 per diluted share, as compared to net income of $37.2 million, or $1.15 per diluted share, in 2005 and net income of $17.2 million, or $0.55 per diluted share, in 2004. These amounts include the following pre-tax charges:
2006 | 2005 | 2004 | ||||||||||
(in thousands) | ||||||||||||
CHARGES |
||||||||||||
Involuntary employee termination costs |
$ | 1,034 | $ | 3,861 | $ | | ||||||
Facility consolidation, acquisition integration,
manufacturing transfer, enterprise business system
integration and related costs |
1,299 | 2,340 | | |||||||||
Acquired in-process research and development |
5,875 | 500 | | |||||||||
Impairment of inventory and fixed assets related to
discontinued product lines |
1,578 | 478 | | |||||||||
Inventory fair market value purchase accounting adjustments |
4,640 | 466 | 270 | |||||||||
Charges associated with convertible debt exchange offer |
1,879 | | | |||||||||
Charges associated with termination of interest rate swap |
1,425 | | | |||||||||
Cash donation to the Integra Foundation |
1,000 | 250 | | |||||||||
Acquired technology licensing and milestone payments |
| | 1,855 | |||||||||
Tax charge incurred in connection with the reorganization
of certain European operations |
| | 1,300 | |||||||||
Total |
$ | 18,730 | $ | 7,895 | $ | 3,425 | ||||||
Of these amounts, $10.9 million, $2.9 million and $0.3 million were charged to cost of product revenues for the years ended December 31, 2006, 2005 and 2004 respectively and $8.8 million, $1.0 million and $0 million were charged to research and development for the same periods. The remaining amounts were primarily charged to selling, general and administrative expenses.
In 2004, we recognized $1.4 million of other income related to an unrealized gain on a foreign currency collar, which was used to reduce our exposure to fluctuations in the exchange rate between the euro and the US dollar as a result of our commitment to acquire Newdeal Technologies for 38.5 million euros. The foreign currency collar expired in January 2005, concurrent with our acquisition of Newdeal Technologies.
We believe that, given our ongoing, active strategy of seeking acquisitions, our current focus on rationalizing our existing manufacturing and distribution infrastructure and our recent review of various product lines in relation to our current business strategy, certain charges and amounts recorded to other income discussed above could recur with similar materiality in the future. We believe that the delineation of these costs provides useful information to measure the comparative performance of our business operations.
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Net income also includes the following amounts:
In 2006, the adoption of SFAS 123R Share-Based Payment resulted in $9.6 million, net of tax, of stock based compensation expense.
In 2005, we recognized an additional $1.3 million of royalty revenue related to a change in the manner we use to estimate royalties earned based on Medtronics sales of its INFUSE® bone graft product. Prior to 2005, we recognized this royalty revenue when paid as Wyeth did not provide information for us to develop a reliable basis for estimating and recording royalty revenue in the same quarter it was earned. However, we now receive timely quarterly royalty revenue information, have sufficient historical information available to help us estimate and the volatility in the royalty earned each quarter has decreased significantly. Accordingly, in 2005 we started recognizing this royalty on an accrual basis in the quarter earned.
In 2004, we recognized a $23.9 million non-cash compensation charge related to the renewal of our President and Chief Executive Officers employment agreement.
These amounts represent revenues, gains and charges resulting from facts and circumstances that, based on our recent history and future expectations, are not expected to recur with similar materiality or effect on continuing operations with the exception of compensation expense under SFAS 123R. SFAS 123R was noted because of the lack of comparability with 2005 and 2004. We believe that the identification of these revenues, charges and gains that meet these criteria promotes comparability of reported financial results for the periods presented.
Total Revenues and Gross Margin
2006 | 2005 | 2004 | ||||||||||
(in thousands, except per share data) | ||||||||||||
Neurosurgical and Orthopedic Implants |
$ | 166,432 | $ | 134,598 | $ | 101,791 | ||||||
Medical Surgical Equipment and other |
252,865 | 143,337 | 128,034 | |||||||||
Total revenues |
419,297 | 277,935 | 229,825 | |||||||||
Cost of product revenues |
168,314 | 107,052 | 88,496 | |||||||||
Gross margin |
250,983 | 170,883 | 141,329 | |||||||||
Gross margin as a percentage of revenues |
60 | % | 61 | % | 61 | % |
In 2006, total revenues increased 51% over 2005 to $419.3 million. Sales of instruments and implant products, which reported a 111% and 21% increase, respectively, in sales over 2005, led our growth in revenues in 2006.
In 2005, total revenues increased 21% over 2004 to $277.9 million. Sales of instruments and implant products, which reported a 38% and 18% increase, respectively, in sales over 2004, led our growth in revenues in 2005.
Reported revenues for 2006 and 2005 included the following amounts in revenues from acquired product lines:
2006 | 2005 | |||||||||||
Revenues | Revenues | % Change | ||||||||||
(in thousands) | ||||||||||||
Total Revenues |
||||||||||||
Products acquired during 2006 |
$ | 98,110 | $ | 0 | N/M | |||||||
Products acquired during 2005 |
23,050 | 17,033 | 35 | % | ||||||||
All other revenues |
298,137 | 260,902 | 14 | % | ||||||||
Total revenues |
419,297 | 277,935 | 51 | % |
All of the products acquired in 2006 were added to the Medical Surgical equipment group, while all of the products acquired in 2005 were added to the Neurosurgical and Orthopedic Implants group.
Revenues excluding 2006 and 2005 acquisitions grew at 14.3% in 2006 as compared to 2005. Increased sales of the following products accounted for a significant portion of this growth: our implant products used for skin replacement and wound dressings; dural repair and repair and protection of peripheral nerves; our surgical instrumentation and ultrasonic surgery systems for tissue ablation; and our Absorbable Collagen Sponge product sold to Wyeth. Changes in foreign currency exchange rates had a $0.6 million favorable effect on the year-over-year increase in revenues.
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Revenues in 2005 and 2004 included $17 million and $3 million, respectively, in sales of products acquired in either 2004 or 2003. Increased sales of our implant products used for skin replacement and wound dressings and dural repair and increased revenues from our Absorbable Collagen Sponge product sold to Wyeth drove this revenue growth. Changes in foreign currency exchange rates in 2005 had a $0.9 million unfavorable effect on the year-over-year increase in revenues.
We have generated our revenue growth through acquisitions, new product launches and increased direct sales and marketing efforts both domestically and in Europe. We expect that our expanded domestic sales forces, the 2005 conversion of Jarit domestic sales from a distributor billing model to a direct billing model, the continued implementation of our direct sales strategy in Europe and sales of internally developed and acquired products will drive our future revenue growth. We also intend to continue to acquire businesses that complement our existing businesses and products.
Gross margin was 60% in 2006, 61% in 2005 and 61% in 2004. Cost of product revenues included $4.6 million, $0.5 million, and $0.3 million in fair value inventory purchase accounting adjustments recorded in connection with acquisitions in 2006, 2005 and 2004, respectively. Our gross margin in 2005 was also negatively affected by $2.6 million of termination costs incurred in connection with our European restructuring activities, $0.9 million of charges associated with facility consolidations and $0.3 million of charges associated with a discontinued product line. Continued growth in sales of higher-margin products, including our skin replacement and wound dressing implants, dural repair implants, cranial stabilization systems, and foot and ankle implant products offset the impact of the charges recorded in 2005.
In 2007, we expect our consolidated gross margin to increase. We expect that sales of our higher gross margin products will continue to increase as a proportion of total revenues. We anticipate that the relatively lower gross margin generated from sales of Radionics and Miltex products will offset some of these benefits.
Other Operating Expenses
The following is a summary of other operating expenses as a percent of total revenues:
2006 | 2005 | 2004 | ||||||||||
Research and development |
6 | % | 4 | % | 6 | % | ||||||
Selling, general and administrative |
38 | % | 35 | % | 43 | % | ||||||
Intangible asset amortization |
2 | % | 2 | % | 2 | % |
The increase in the above expenses is partially related to a $5.9 million in-process research and development charge related to the acquisition of KMI, $14 million stock-based compensation expense associated with the adoption of SFAS 123R (the majority of which is included in selling, general and administrative expense) and higher commission expense associated with the Jarit direct bill initiative. Expenses also increased because of the continued expansion of our direct sales and marketing organizations in our direct selling platforms and increased corporate staff to support the recent growth in our business to integrate acquired businesses. The Radionics, Miltex, KMI and Canada Microsurgical businesses contributed approximately $30.6 million in other operating expenses in 2006.
Research and development expenses in 2006 increased by $14 million compared to 2005, to $26 million. Included in research and development costs during 2006 were a $5.9 million in-process research and development charge related to the KMI acquisition, a $0.5 million charge related to an up-front payment pursuant to a new product development alliance and $0.6 million of stock-based compensation expense associated with the adoption of SFAS 123R. In addition to these charges, research and development expenses increased by $3.0 million in 2006 as a result of the acquisitions of Radionics and KMI. We recognized a $1.6 million impairment of inventory and fixed assets associated with a discontinued project for the development of an ultrasonic aspirator system. This project was discontinued in June 2006 following our review of our existing technology and the ultrasonic aspirator technology acquired in the Radionics acquisition. We determined there was no future, alternative use for the inventory or fixed assets in any other development project. There was also an overall increase of $4.2 million associated with product development initiatives compared to the prior-year period.
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In 2005, we had a $0.5 million in-process research and development charge related to intellectual property acquired from Eunoe, Inc. Prior to ceasing operations, Eunoe, Inc. was engaged in the development of the COGNIShunt® system for the treatment of Alzheimers disease patients. The acquired intellectual property has not been developed into a product that has been approved or cleared by the FDA and has no future alternative use other than in clinical applications involving the regulation of cerebrospinal fluid.
In 2007, we expect our research and development expenses as a percentage of total revenues to increase slightly as we increase expenditures on research and clinical activities. These activities will be directed toward expanding the indications for use of our absorbable implant technology products, including a multi-center clinical trial suitable to support an application to the FDA for approval of the DuraGen Plus® Adhesion Barrier Matrix product in the United States. The acquired Radionics business also adds to our research and development spending.
In 2006, selling, general and administrative expenses increased $59.4 million, or 60% as compared to the prior-year period, to $157.7 million. This increase includes $13.1 million of stock-based compensation expense associated with the adoption of SFAS 123R and higher commission expenses associated with the Jarit direct bill initiative. Selling, general and administrative costs also increased in 2006 in connection with the recently acquired Radionics, Miltex, KMI and Canada Microsurgical businesses. We also continue to expand our direct sales and marketing organizations in our direct selling platforms and increased corporate staff to support the recent growth in our business and to integrate acquired businesses. Additionally, we have incurred higher operating costs in connection with our recent investments in our infrastructure, including the continued implementation of an enterprise business system and the relocation and expansion of our domestic and international distribution capabilities through third-party service providers. We expect to incur costs related to these activities in 2007 as we complete these on-going activities.
In 2004, our selling, general and administrative expenses included a $23.9 million share-based compensation charge related to the renewal of our President and Chief Executive Officers employment agreement. Excluding the impact of this charge, selling, general and administrative expenses increased in 2005 because of the continued expansion of our direct sales and marketing organizations in our direct selling platforms, increased corporate staff to support the growth in our business and costs associated with our restructuring, acquisition integration and systems implementation activities. Since 2004, we have been investing resources in the continued implementation of a new global enterprise business system. In 2004 and 2005, we relocated and expanded most of our domestic and international distribution capabilities through third-party service providers.
In 2005, we recorded $1.1 million of employee termination costs and $1.4 million of charges associated with facility consolidations, acquisition integrations and related costs incurred in connection with our restructuring activities in selling, general and administrative expenses. In 2006, we recorded $1.0 million of employee termination costs associated with further restructuring of our European sales and marketing operations.
In 2005, we also recorded $8.3 million of selling, general and administrative expenses associated with the Newdeal business acquired in January 2005. These costs included a $1.4 million compensation charge related to the sellers obligation to continue their employment with Newdeal through the end of 2005.
Amortization expense increased to $11.6 million in 2006 because of amortization on intangible assets acquired through our business acquisitions. Including the impact of intangible assets acquired in the Radionics, Miltex, KMI and Canada Microsurgical acquisitions, we expect annual amortization expense to be approximately $14.3 million in 2007, $13.9 million in 2008, $12.5 million in 2009, $10.8 million in 2010 and $10.6 million in 2011.
Non-Operating Income and Expenses
Interest expense primarily relates to the $120 million of 21/2% contingent convertible subordinated notes that we have outstanding, a related interest rate swap agreement, which was terminated on September 27, 2006, and interest and fees relating to our senior secured credit facility. The increase in interest expense for the year ended December 31, 2006 is primarily related to the write-off of unamortized debt issuance costs related to the old notes discussed below and interest associated with our credit facility. In 2006, we made net additional borrowings of $100 million under our credit facility.
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On September 27 and October 20, 2006, we exchanged $119.5 million (out of a total of $120.0 million) of our old contingent convertible notes for the equivalent amount of new notes. See Note 5 to the financial statements for a further discussion. In connection with the exchange of our convertible notes, we recorded a $1.2 million write-off of the unamortized debt issuance costs and $0.3 million of fees associated with the old contingent convertible notes that were exchanged. Our reported interest expense for the years ended December 31, 2006, 2005, and 2004 included $0.6 million, $0.8 million, and $0.8 million, respectively, of non-cash amortization of debt issuance costs.
In 2003, we received approximately $115.9 million of net proceeds from the sale of $120.0 million of our 21/2% contingent convertible subordinated notes due in March 2008. In 2006, 2005, and 2004 we recorded interest expense of $3.0 million, $3.0 million, and $3.0 million, respectively, in connection with these notes. In addition, we recorded interest income on our invested cash and marketable debt securities of $1.3 million, $3.9 million and $4.0 million in 2006, 2005 and 2004, respectively.
We will pay additional interest (contingent interest) on our convertible notes if, at thirty days prior to maturity, our common stock price is greater than $37.56 per share. We recorded a $0.4 million liability related to the estimated fair value of the contingent interest obligation at the time the notes were issued. The contingent interest obligation, which remains unchanged by the exchange, is marked to its fair value at each balance sheet date, with changes in the fair value recorded to interest expense. At December 31, 2006, the estimated fair value of the contingent interest obligation was $1.1 million. In 2006, we recorded $0.4 million of interest expense associated with changes in the estimated fair value of the contingent interest obligation. In 2005, interest expense associated with changes in the estimated fair value of the contingent interest obligation was not significant. In 2004, we recorded $0.3 million of interest expense associated with changes in the estimated fair value of the contingent interest obligation.
In August 2003, we entered into an interest rate swap agreement with a $50.0 million notional amount to hedge the risk of changes in fair value attributable to interest rate risk with respect to a portion of our fixed-rate convertible notes. We received a 21/2% fixed rate from the counterparty, payable on a semi-annual basis, and paid to the counterparty a floating rate based on 3-month LIBOR minus 35 basis points, payable on a quarterly basis. The interest rate swap agreement was scheduled to terminate in March 2008, subject to early termination upon the occurrence of certain events, including redemption or conversion of the convertible notes. On September 27, 2006, we terminated this interest rate swap agreement in connection with the exchange of our convertible notes. The interest rate swap agreement qualified as a fair value hedge under SFAS No. 133, as amended Accounting for Derivative Instruments and Hedging Activities. The net amount to be paid or received under the interest rate swap agreement was recorded as a component of interest expense.
We paid the counterparty approximately $2.2 million in connection with the termination of the swap, consisting of a $0.6 million payment of accrued interest and a $1.6 million payment representing the fair market value of the interest rate swap on the termination date. We had already accrued the termination payment. Historically, the net difference between changes in the fair value of the interest rate swap and the contingent convertible notes represented the ineffective portion of the hedging relationship, and this amount was recorded in other income / (expense) net.
We recorded the following changes in the net fair values of the interest rate swap and the hedged portion of the contingent convertible notes (2006 amounts were incurred prior to termination):
2006 | 2005 | 2004 | ||||||||||
(in thousands) | ||||||||||||
Interest rate swap |
$ | (690 | ) | $ | 690 | $ | 287 | |||||
Contingent convertible notes |
343 | (821 | ) | (430 | ) | |||||||
Net increase (decrease) in liabilities |
$ | (347 | ) | $ | (131 | ) | $ | (143 | ) | |||
Our net other income (expense) increased in 2006 by $1.2 million to $2.0 million of expense. In 2006, we recognized $1.4 million in other expense related to the interest rate swap unwind. See Note 6 Derivative Instruments for a further discussion. In 2004, we recorded a $1.4 million unrealized gain associated with a 38.5 million euro foreign currency collar contract that expired on January 3, 2005, concurrent with our acquisition of Newdeal. We entered into this contract to reduce our exposure to fluctuations in the exchange rate between the euro and the dollar as a result of our commitment to acquire Newdeal in January 2005 for 38.5 million euros. The collar contract did not qualify as a hedge under SFAS No. 133. Accordingly, the collar contract was recorded at fair value and changes in fair value were recorded in other income (expense), net.
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Income Taxes
In 2006, our effective income tax rate was 39.1% of income before income taxes, compared to 32.5% in 2005 and 38.6% in 2004. The 2006 rate includes a $2.1 million tax charge for the write-off of in-process research and development related to the acquisition of KMI, which is nondeductible for tax purposes and a $0.7 million charge related to the newly adopted accounting treatment for incentive stock options under SFAS 123R. The increase in our effective tax rate from 2005 to 2006 was primarily related to the impact of these charges, as well as, the changes in the geographical mix of taxable income attributable to recently acquired businesses. Our 2004 rate includes a $1.3 million tax charge related to the transfer of intangible assets. The reduction in our effective tax rate from 2004 to 2005 was primarily related to the impact of this charge on our 2004 effective rate and the favorable impact of various planning and reorganization initiatives that we implemented in 2005.
Our effective tax rate could vary from year to year depending on, among other factors, the geographic and business mix of taxable earnings and losses. We consider these factors and others, including our history of generating taxable earnings, in assessing our ability to realize deferred tax assets.
The net decrease in our tax asset valuation allowance was $3.5 million, $0.2 million, and $0 million in 2006, 2005 and 2004, respectively. The change in 2006 was recorded against the gross amount of the related deferred tax asset.
A valuation allowance of $1.6 million is recorded against the remaining $24.0 million of net deferred tax assets recorded at December 31, 2006. This valuation allowance relates to deferred tax assets for certain expenses which will be deductible for tax purposes in very limited circumstances and for which we believe it is unlikely that we will recognize the associated tax benefit. We do not anticipate additional income tax benefits through future reductions in the valuation allowance. However, if we determine that we would be able to realize more or less than the recorded amount of net deferred tax assets, we will record an adjustment to the deferred tax asset valuation allowance in the period such a determination is made.
At December 31, 2006, we had net operating loss carryforwards of $11.0 million for federal income tax purposes and $2.3 million for foreign income tax purposes to offset future taxable income. The federal net operating loss carryforwards expire through 2010, and the foreign net operating loss carryforwards have no expiration. We used all of our remaining unrestricted net operating loss carryforwards in 2006.
At December 31, 2006, certain of our subsidiaries had unused net operating loss carryforwards and tax credit carryforwards arising from periods prior to our ownership which expire through 2010. The Internal Revenue Code limits the timing and manner in which we may use any acquired net operating losses or tax credits.
We do not provide income taxes on undistributed earnings of non-U.S. subsidiaries because such earnings are expected to be permanently reinvested. Undistributed earnings of foreign subsidiaries totaled $20.3 million, $8.5 million and $2.6 million, at December 31, 2006, 2005 and 2004, respectively.
The American Jobs Creation Act of 2004 was signed into law in October 2004 and has several provisions that may impact our income taxes in the future, including the repeal of the extraterritorial income exclusion and a deduction related to qualified production activities income. The qualified production activities deduction is a special deduction and will have no impact on deferred taxes existing at the enactment date. Rather, the impact of this deduction will be reported in the period in which the deduction is claimed on our tax return. Pursuant to United States Department of Treasury Regulations issued in October 2005, we have realized a tax benefit on qualified production activities income of $0.3 million in 2006.
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INTERNATIONAL REVENUES AND OPERATIONS
Revenues by major geographic area are summarized below:
United States | Europe | Asia Pacific | Other Foreign | Consolidated | ||||||||||||||||
(in thousands) | ||||||||||||||||||||
2006
|
$ | 317,503 | $ | 77,100 | $ | 12,315 | $ | 12,379 | $ | 419,297 | ||||||||||
2005
|
207,409 | 48,645 | 11,403 | 10,478 | 277,935 | |||||||||||||||
2004
|
182,168 | 30,994 | 8,535 | 8,128 | 229,825 |
In 2006, revenues from customers outside the United States totaled $101.9 million or 24% of consolidated revenues, of which approximately 76% were sales to European customers. Revenues from customers outside the United States included $57.6 million of revenues generated in foreign currencies.
In 2005, revenues from customers outside the United States totaled $70.5 million, or 25% of consolidated revenues, of which approximately 69% were sales to European customers. Revenues from customers outside the United States included $55.2 million of revenues generated in foreign currencies.
In 2004, revenues from customers outside the United States totaled $47.6 million, or 21% of consolidated revenues, of which approximately 65% were sales to European customers. Revenues from customers outside the United States included $33.6 million of revenues generated in foreign currencies.
Because we have operations based in Europe and we generate revenues and incur operating expenses in euros and British pounds, we will experience currency exchange risk with respect to those foreign currency denominated revenues or expenses. We also experience currency exchange risk with respect to the yen.
We currently do not hedge our exposure to operating foreign currency risk. Accordingly, a weakening of the dollar against the Euro and British pound could negatively affect future gross margins and operating margins. We will continue to assess the potential effects that changes in foreign currency exchange rates could have on our business. If we believe this potential impact presents a significant risk to our business, we may enter into derivative financial instruments to mitigate this risk.
Additionally, we generate significant revenues outside the United States, a portion of which are U.S. dollar-denominated transactions conducted with customers who generate revenue in currencies other than the U.S. dollar. As a result, currency fluctuations between the U.S. dollar and the currencies in which those customers do business may have an impact on the demand for our products in foreign countries.
Local economic conditions, regulatory or political considerations, the effectiveness of our sales representatives and distributors, local competition and changes in local medical practice all could combine to affect our sales into markets outside the United States.
Relationships with customers and effective terms of sale frequently vary by country, often with longer-term receivables than are typical in the United States.
LIQUIDITY AND CAPITAL RESOURCES
Cash and Marketable Securities
At December 31, 2006, we had cash, cash equivalents and marketable securities totaling $22.6 million. Investments consist almost entirely of highly liquid, interest bearing debt securities. In the third quarter of 2006, we liquidated our portfolio of marketable securities.
34
Cash Flows
We generated positive operating cash flows of $71.7 million, $57.0 million, and $39.0 million in 2006, 2005 and 2004, respectively. Operating cash flows continued to improve primarily as a result of higher pre-tax income, improved working capital management, and the benefits from the continued utilization of our net operating loss carryforwards and tax deductions generated by employee stock option exercises. In 2006, 2005 and 2004, changes in working capital items reduced operating cash flows by $4.5 million, $4.7 million and $20.2 million, respectively. In 2004, we experienced delays in customer collections related to enterprise business systems transitions. The improvement in working capital in 2005 relates to an improvement in the collection cycle for accounts receivable.
Our principal uses of funds for the year ended December 31, 2006 was $228.7 million for acquisition consideration, $70 million paid for the purchase of 1.8 million shares for our common stock and $11.5 million in capital expenditures. We received $109.9 million in cash from sales and maturities of available for sale securities, net of purchases. In addition to the $71.7 million in operating cash flows for the year ended December 31, 2006, we received $15.9 million from the issuance of common stock through the exercise of stock options during the period and $100 million from borrowings under our credit facility.
In 2005, we used $56.3 million to repurchase 1.7 million shares of our common stock, which was partially offset by $9.4 million in cash flows generated from the issuance of common stock under employee benefit plans. Other principal uses of funds in 2005 were $50.6 million for acquisitions and $8.1 million for capital expenditures. In 2005, we generated $27.8 million of cash flows from the net sales and maturities of our investments in marketable debt securities.
In 2004, we generated $6.1 million from the issuance of common stock under employee benefit plans. We used $29.3 million of cash for acquisitions, $50.6 million for the net purchases of marketable debt securities, $14.2 million for the repurchase of 500,000 shares of our common stock and $8.5 million for capital expenditures.
Working Capital
At December 31, 2006 and 2005, working capital was $(52.4) million and $234.7 million, respectively. The decrease in working capital in 2006 was primarily related to the use of $228.7 million for acquisitions. Also contributing to the decrease was the reclassification of $119.5 million of contingent convertible notes to current liabilities. Such classification was made because the closing price of our stock on the issuance date of the new convertible notes was higher than the market price trigger of the new convertible notes. The noteholders have the option to convert new convertible notes into cash and, if applicable, shares of our common stock.
Convertible Debt and Related Hedging Activities
We pay interest on our contingent convertible subordinated notes at an annual rate of 21/2% each September 15 and March 15. We will also pay contingent interest on the notes if, at thirty days prior to maturity, our common stock price is greater than $37.56. The contingent interest will be payable at maturity for each of the last three years the notes remain outstanding in an amount equal to the greater of (1) 0.50% of the face amount of the notes and (2) the amount of regular cash dividends paid during each such year on the number of shares of common stock into which each note is convertible. Holders of the notes may convert the notes under certain circumstances, including when the market price of our common stock on the previous trading day is more than $37.56 per share, based on an initial conversion price of $34.15 per share.
The notes are general, unsecured obligations of Integra and will be subordinate to any future senior indebtedness. We cannot redeem the notes prior to their maturity, and the noteholders may compel us to repurchase the notes upon a change of control. There are no financial covenants associated with the convertible notes.
35
On September 27, 2006, we concluded an offer to exchange up to $120 million principal amount of new notes with a net share settlement mechanism for our then outstanding contingent convertible subordinated notes. As of that date, an aggregate principal amount of $115.2 million of old notes was tendered. The terms of the new notes are substantially similar to those of the old notes, except that the new notes have a net share settlement feature and include takeover protections, whereby we will pay a premium to holders who convert their notes upon the occurrence of designated events, including a change in control. The net share settlement feature of the new notes requires that, upon conversion of the new notes, we will pay holders in cash for up to the principal amount of the converted new notes, with any amount in excess of the cash amount settled, at our election, in cash or shares of our common stock. Holders who exchanged their old notes in the exchange offer received an exchange fee of $2.50 per $1,000 principal amount of their old notes. We paid approximately $288,000 of exchange fees to tendering holders of the existing notes plus expenses totaling approximately $332,000 in connection with the offer.
On October 20, 2006 an additional $4.3 million of old notes were tendered, bringing the total amount of exchanges to $119.5 million, or 99.6% of the original $120 million principal amount. We paid approximately $11,000 of exchange fees to tendering holders of these notes in connection with this exchange.
On September 27, 2006, we terminated our interest rate swap agreement with a $50 million notional amount to hedge the risk of changes in fair value attributable to interest rate risk with respect to a portion of the notes. See Results of Operation Non-Operating Income and Expenses.
Share Repurchase Plans
During 2006, 2005, and 2004, we repurchased 1.8 million, 1.7 million, and 0.5 million shares, respectively, of our common stock under authorized share repurchase programs. We hold repurchased shares as treasury shares and may use them for general corporate purposes, including acquisitions and for issuance upon exercise of outstanding stock options.
In May 2005, our Board of Directors authorized us to repurchase shares of our common stock for an aggregate purchase price not to exceed $40 million through December 31, 2006. We were authorized to repurchase no more than 1.5 million shares under this program. In October 2005, our Board of Directors terminated the May 2005 repurchase program and adopted a new program that authorized us to repurchase shares of our common stock for an aggregate purchase price not to exceed $50 million through December 31, 2006. During 2005, we repurchased approximately 1.7 million shares of our common stock for $56.3 million under the May 2005 and October 2005 repurchase programs.
In February 2006, our Board of Directors authorized us to repurchase shares of our common stock for an aggregate purchase price not to exceed $50 million though December 31, 2006 and terminated our prior repurchase program.
In October 2006, our Board of Directors terminated the repurchase program approved in February 2006 and adopted a new program that authorizes us to repurchase shares or our common stock for an aggregate purchase price not to exceed $75 million though December 31, 2007. Shares may be purchased either in the open market or in privately negotiated transactions.
Dividend Policy
We have not paid any cash dividends on our common stock since our formation. Our credit facility limits the amount of dividends that we may pay. Any future determinations to pay cash dividends on our common stock will be at the discretion of our Board of Directors and will depend upon our financial condition, results of operations, cash flows and other factors that the Board of Directors deems relevant.
Requirements and Capital Resources
We believe that our cash and marketable securities are sufficient to finance our operations and capital expenditures in the near term.
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In December 2005, we established a $200 million, five-year, senior secured revolving credit facility. We plan to utilize the credit facility for working capital, capital expenditures, share repurchases, acquisitions and other general corporate purposes. We did not draw any amounts against this credit facility in 2005. We made borrowings in 2006 for acquisition-related purposes. As of December 31, 2006, we had $100 million of outstanding borrowings under our credit facility at a weighted average interest rate of 6.5% per annum. We amended the credit facility in February 2007 to increase the size of the credit facility to $300 million, which can be increased to $400 million should additional financing be required in the future. We make regular borrowings and payments each month against the credit facility and consider the outstanding amounts to be short-term in nature.
The indebtedness under the credit facility is guaranteed by all but one of our domestic subsidiaries. The Companys obligations under the credit facility and the guarantees of the guarantors are secured by a first-priority security interest in all present and future capital stock of (or other ownership or profit interest in) each guarantor and substantially all of the Companys and the guarantors other assets, other than real estate, intellectual property and capital stock of foreign subsidiaries.
Borrowings under the credit facility bear interest, at our option, at a rate equal to (i) the Eurodollar Rate in effect from time to time plus an applicable rate (ranging from 0.375% to 1.25%) or (ii) the higher of (x) the weighted average overnight Federal funds rate, as published by the Federal Reserve Bank of New York, plus 0.5%, and (y) the prime commercial lending rate of Bank of America, N.A. plus an applicable rate (ranging from 0% to 0.25%). The applicable rates are based on a financial ratio at the time of the applicable borrowing.
We will also pay an annual commitment fee (ranging from 0.10% to 0.20%) on the daily amount by which the commitments under the credit facility exceed the outstanding loans and letters of credit under the credit facility.
The credit facility requires us to maintain various financial covenants, including leverage ratios, a minimum fixed charge coverage ratio and a minimum liquidity ratio. The credit facility also contains customary affirmative and negative covenants, including those that limit the Companys and its subsidiaries ability to incur additional debt, incur liens, make investments, enter into mergers and acquisitions, liquidate or dissolve, sell or dispose of assets, repurchase stock and pay dividends, engage in transactions with affiliates, engage in certain lines of business and enter into sale and leaseback transactions. The Company was in compliance with such covenants at each balance sheet date.
Contractual Obligations and Commitments
As of December 31, 2006, we were obligated to pay the following amounts under various agreements:
Less than | 1-3 | 3-5 | More than | |||||||||||||||||
Total | 1 year | Years | Years | 5 years | ||||||||||||||||
(in millions) | ||||||||||||||||||||
Convertible Securities Short Term |
$ | 119.5 | $ | 119.5 | $ | | $ | | $ | | ||||||||||
Convertible Securities Long Term |
0.5 | | 0.5 | | | |||||||||||||||
Interest on Convertible Securities |
4.5 | 3.0 | 1.5 | | | |||||||||||||||
Employment Agreements |
5.5 | 3.1 | 2.4 | | | |||||||||||||||
Operating Leases |
18.4 | 4.1 | 5.2 | 1.9 | 7.2 | |||||||||||||||
Purchase Obligations |
1.0 | 1.0 | | | | |||||||||||||||
Warranty Obligations |
1.3 | 1.1 | 0.2 | | | |||||||||||||||
Pension Contributions |
0.3 | 0.3 | | | | |||||||||||||||
Total |
$ | 151.0 | $ | 132.1 | $ | 9.8 | $ | 1.9 | $ | 7.2 | ||||||||||
In addition, under other agreements we are required to make payments based on sales levels of certain products.
The above table does not include contingent interest that we may be obligated to pay on our contingent convertible subordinated notes due in March 2008. See Results of Operations Non-Operating Income and Expenses.
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CRITICAL ACCOUNTING POLICIES AND THE USE OF ESTIMATES
Our discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities, and the reported amounts of revenues and expenses. Significant estimates affecting amounts reported or disclosed in the consolidated financial statements include allowances for doubtful accounts receivable and sales returns and allowances, net realizable value of inventories, amortization periods for acquired intangible assets, goodwill, discount rates used to value and test impairments of long-lived assets, computation of taxes, valuation allowances recorded against deferred tax assets, the valuation of stock-based compensation, estimates of projected cash flows and depreciation and amortization periods for long-lived assets, in-process research and development charges and loss contingencies. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the current circumstances. Actual results could differ from these estimates.
We believe the following accounting policies, which form the basis for developing these estimates, are those that are most critical to the presentation of our financial statements and require the most difficult, subjective and complex judgments:
Goodwill and Other Intangible Assets
We review goodwill and purchased intangible assets with indefinite lives for impairment annually and whenever events or changes indicate that the carrying value of an asset may not be recoverable in accordance with the Financial Accounting Standards Board, or FASB, Statement of Financial Accounting Standards, or SFAS, No. 142 Goodwill and Other Intangible Assets. These events or circumstances could include a significant change in the business climate, legal factors, operating performance indicators, competition, or sale or disposition of significant assets or products. Application of the goodwill impairment test requires significant judgments, including estimation of future cash flows, which is dependent on internal forecasts, estimation of the long-term rate of growth for our business, the useful life over which cash flow will occur and determination of our weight-average cost of capital. Changes in these estimates and assumptions could materially affect the determination of fair value and/or goodwill impairment.
Allowances For Doubtful Accounts Receivable and Sales Returns and Allowances
We evaluate the collectibility of accounts receivable based on a combination of factors. In circumstances where a specific customer is unable to meet its financial obligations to us, we record an allowance against amounts due to reduce the net recognized receivable to the amount that we reasonably expect to collect. For all other customers, we record allowances for doubtful accounts based on the length of time the receivables are past due, the current business environment and our historical experience. If the financial condition of customers or the length of time that receivables are past due were to change, we may change the recorded amount of allowances for doubtful accounts in the future through charges or reductions to selling, general and administrative expense.
We record a provision for estimated sales returns and allowances on revenues in the same period as the related revenues are recorded. We base these estimates on historical sales returns and allowances and other known factors. If actual returns or allowances are different from our estimates and the related provisions for sales returns and allowances, we may change the sales returns and allowances provision in the future through an increase or decrease in revenues.
Inventories
Inventories, consisting of purchased materials, direct labor and manufacturing overhead, are stated at the lower of cost (determined by the first-in, first-out method) or market. At each balance sheet date, we evaluate ending inventories for excess quantities, obsolescence or shelf-life expiration. Our evaluation includes an analysis of historical sales levels by product, projections of future demand by product, the risk of technological or competitive obsolescence for our products, general market conditions, a review of the shelf-life expiration dates for our products, and the feasibility of reworking or using excess or obsolete products or components in the
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production or assembly of other products that are not obsolete or for which we do not have excess quantities in inventory. To the extent that we determine there are excess or obsolete quantities or quantities with a shelf life that is too near its expiration for us to reasonably expect that we can sell those products prior to their expiration, we record valuation reserves against all or a portion of the value of the related products to adjust their carrying value to estimated net realizable value. If future demand or market conditions are different from our projections, or if we are unable to rework excess or obsolete quantities into other products, we may change the recorded amount of inventory valuation reserves through a charge or reduction in cost of product revenues in the period the revision is made.
We capitalize inventory costs associated with certain products prior to regulatory approval, based on managements judgment of probable future commercialization. We could be required to expense previously capitalized costs related to pre-approval inventory upon a change in such judgment, due to, among other potential factors, a denial or delay of approval by necessary regulatory bodies or a decision by management to discontinue the related development program. At December 31, 2006, we had no capitalized pre-approval inventory. If management decides to discontinue the related development program or we are not able to obtain the required approvals from regulatory bodies to market these products, we would expense the value of the capitalized pre-approval inventory to research and development expense.
Amortization Periods
We provide for amortization using the straight-line method over the estimated useful lives of acquired intangible assets. We base the determination of these useful lives on the period over which we expect the related assets to contribute to our cash flows or a shorter period such that recognition of the amortization better corresponds with the distribution of expected revenues. If our assessment of the useful lives of intangible assets changes, we may change future amortization expense.
Loss Contingencies
We are subject to claims and lawsuits in the ordinary course of our business, including claims by employees or former employees, with respect to our products and involving commercial disputes. We accrue for loss contingencies in accordance with SFAS 5; that is, when it is deemed probable that a loss has been incurred and that loss is estimable. The amounts accrued are based on the full amount of the estimated loss before considering insurance proceeds, and do not include an estimate for legal fees expected to be incurred in connection with the loss contingency. We consistently accrue legal fees expected to be incurred in connection with loss contingencies as those fees are incurred by outside counsel as a period cost, as permitted by EITF Topic D-77. Our financial statements do not reflect any material amounts related to possible unfavorable outcomes of claims and lawsuits to which we are currently a party because we currently believe that such claims and lawsuits are not expected, individually or in the aggregate, to result in a material adverse effect on our financial condition. However, it is possible that these contingencies could materially affect our results of operations, financial position and cash flows in a particular period if we change our assessment of the likely outcome of these matters.
Income Taxes
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and their basis for income tax purposes and the tax effects of capital loss, net operating loss and tax credit carryforwards. We record valuation allowances to reduce deferred tax assets to the amounts that are more likely than not to be realized. We could recognize no benefit from our deferred tax assets or we could recognize some or all of the future benefit depending on the amount and timing of taxable income we generate in the future.
Stock-Based Compensation Expense
Prior to the adoption of SFAS 123R, employee stock-based compensation was recognized using the intrinsic value method. The Company did not include compensation expense for employee stock options in net income because stock options were granted with an exercise price equal to the fair market value on the date of grant.
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Effective January 1, 2006, we account for stock-based compensation costs in accordance with SFAS 123R, which requires the measurement and recognition of compensation expense for all stock-based payment awards made to our employees and directors. Under the fair value recognition provision of SFAS 123R, stock-based compensation is measured at the grant date based on the value of the award and is recognized as expense over the vesting period. Determining the fair value of stock-based awards at the grant date requires considerable judgment, including estimated expected volatility, expected term and risk-free rate. Our expected volatility is based on historical volatility of our stock price with forward-looking assumptions. The expected life of the stock options is estimated based on historical data on exercise of stock options. The risk-free interest rate is based on the yield at the time of grant of a U.S. treasury security with an equivalent remaining term. If factors change and we employ differ assumptions, stock-based compensation expense may differ significantly from what we have recorded in the past.
OTHER MATTERS
Recently Issued Accounting Standards
In July 2006, the FASB issued FIN 48, which clarifies the accounting for uncertainty in tax positions. This interpretation requires an entity to recognize the impact of a tax position in its financial statements if that position is more likely than not to be sustained on audit based on the technical merits of the position. The provisions of FIN 48 are effective for us as of January 2007. Any cumulative effect of the change in accounting principle will be recorded as an adjustment to the opening retained earnings. We are evaluating the potential effect of implementing FIN 48 on our financial condition and results of operation.
In September 2006, the FASB issued statement No. 157 Fair Value Measurements, or SFAS 157. SFAS 157 defines fair value, establishes a framework for measuring fair value in accordance with accounting principles generally accepted in the United States, and expands disclosure about fair value measurements. SFAS 157 is in effect for us as of the beginning of fiscal year 2008. Any cumulative effect will be recorded as an adjustment to the opening retained earnings. We are evaluating the potential effects of implementing this Statement on our financial condition and results of operation.
In September 2006, the SEC staff issued Staff Accounting Bulletin No. 108 Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, or SAB 108. SAB 108 was issued in order to reduce the diversity in practice in how public companies quantify misstatements of financial statements, including misstatements that were not material to prior years financial statements. SAB 108 is effective for fiscal year 2006. The implementation of SAB 108 did not have a material impact on the Companys financial position or results of operations.
In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159 The Fair Value Option for Financial Assets and Financial Liabilities, or SFAS 159. The Statement provides companies an option to report certain financial assets and liabilities at fair value. The intent of SFAS 159 is to reduce the complexity in accounting for financial instruments and the volatility in earnings caused by measuring related assets and liabilities differently. SFAS 159 is effective for financial statements issued for fiscal years after November 15, 2007. We are evaluating the impact this new standard will have on its financial position and results of operations.
ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to various market risks, including changes in foreign currency exchange rates and interest rates that could adversely affect our results of operations and financial condition. To manage the volatility relating to these typical business exposures, we may enter into various derivative transactions when appropriate. We do not hold or issue derivative instruments for trading or other speculative purposes.
Foreign Currency Exchange Rate Risk
Because we have operations based in Europe and we generate revenues and incur operating expenses in euros and British pounds, we will experience currency exchange risk with respect to those foreign currency denominated revenues or expenses. A weakening of the dollar against the euro and British pound could positively affect future revenues and negatively affect future gross margins and operating margins, while strengthening of the dollar against the euro and the British pound could negatively affect future revenues and positively affect future gross margins and operating margins.
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In November 2004, we entered into a collar contract that expired on January 3, 2005 for 38.5 million euros to reduce our exposure to fluctuations in the exchange rate between the euro and the US dollar as a result of our commitment to acquire Newdeal in January 2005 for 38.5 million euros. The collar contract did not qualify as a hedge under SFAS No. 133. Accordingly, the collar contract was recorded at fair value and changes in fair value were recorded in other income (expense), net. In 2004, we recorded a $1.4 million unrealized gain related to the change in the fair value of the collar contract as of December 31, 2004. The foreign currency collar expired in January 2005, concurrent with our acquisition of Newdeal.
Other than this foreign currency collar, we have not used derivative financial instruments to manage foreign currency risk. As the volume of our business transacted in foreign currencies increases, we will continue to assess the potential effects that changes in foreign currency exchange rates could have on our business. If we believe this potential impact presents a significant risk to our business, we may enter into additional derivative financial instruments to mitigate this risk.
Interest Rate Risk Marketable Debt Securities
We are exposed to the risk of interest rate fluctuations on the fair value and interest income earned on our cash and cash equivalents and investments in available-for-sale marketable debt securities. A hypothetical 100 basis point movement in interest rates applicable to our cash and cash equivalents and investments in marketable debt securities outstanding at December 31, 2006 would increase or decrease interest income by approximately $0.2 million on an annual basis. We are not subject to material foreign currency exchange risk with respect to these investments.
Interest Rate Risk Long-Term Debt and Related Hedging Instruments
On September 27, 2006, we terminated our $50.0 million notional amount interest rate swap used to hedge the risk of changes in fair value attributable to interest rate risk with respect to a portion of our $120.0 million principal amount fixed-rate 21/2% contingent convertible subordinated notes due March 2008. We received a 21/2% fixed rate from the counterparty, payable on a semi-annual basis, and paid to the counterparty a floating rate based on 3-month LIBOR minus 35 basis points, payable on a quarterly basis. The floating rate reset each quarter.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Financial statements and the financial statement schedules specified by this Item, together with the reports thereon of PricewaterhouseCoopers LLP, are presented following Item 15 of this report.
Information on quarterly results of operations is set forth in our financial statements under Note 16 Selected Quarterly Information Unaudited to the Consolidated Financial Statements.
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 maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commissions rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure. Disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Management has designed our disclosure controls and procedures to provide reasonable assurance of achieving the desired control objectives.
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As required by Exchange Act Rule 13a-15(b), we have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2006. Based on the foregoing, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.
Managements Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). 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 based on the framework in Internal Control Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under the framework in Internal Control Integrated Framework, our management concluded that our internal control over financial reporting was effective as of December 31, 2006. Our managements assessment of the effectiveness of our internal control over financial reporting as of December 31, 2006 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which is included herein.
In conducting our evaluation of the effectiveness of our internal control over financial reporting, we have excluded the acquisitions of Miltex, Canada Microsurgical and KMI, which were completed on May 12, 2006, July 6, 2006 and July 31, 2006, respectively. The total assets and total revenues associated with these transactions and balances accounted for under these companies internal controls over financial reporting represent 30% and 11%, respectively, of the consolidated financial statements as of and for the year ended December 31, 2006.
Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
Changes in Internal Control Over Financial Reporting
No changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the quarter ended December 31, 2006, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
Not applicable.
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PART III
INCORPORATED BY REFERENCE
The information called for by Item 10. Directors and Executive Officers of the Registrant (other than the information concerning executive officers set forth after Item 4 of Part I herein), Item 11. Executive Compensation, Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters, Item 13. Certain Relationships and Related Transactions, and Director Independence and Item 14. Principal Accountant Fees and Services is incorporated herein by reference to the Companys definitive proxy statement for its Annual Meeting of Stockholders scheduled to be held on May 17, 2007, which definitive proxy statement is expected to be filed with the Commission not later than 120 days after the end of the fiscal year to which this report relates.
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The following financial statements and financial statement schedules are filed as a part of this report: |
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F-1 | ||||
F-3 | ||||
F-4 | ||||
F-5 | ||||
F-6 | ||||
F-7 | ||||
2. Financial Statement Schedules. |
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F-40 |
3.1(a) |
Amended and Restated Certificate of Incorporation of the Company (Incorporated by reference to Exhibit 3.1(a) to the Companys Annual Report on Form 10-K for the year ended December 31, 2005) | |
3.1(b) | Certificate of Amendment to Amended and Restated Certificate of Incorporation dated May 22, 1998 (Incorporated by reference to Exhibit 3.1(b) to the Companys Annual Report on Form 10-K for the year ended December 31, 1998) | |
3.1(c) | Certificate of Amendment to Amended and Restated Certificate of Incorporation dated May 17, 1999 (Incorporated by reference to Exhibit 3.1(c) to the Companys Annual Report on Form 10-K for the year ended December 31, 2004) | |
3.2 | Amended and Restated By-laws of the Company (Incorporated by reference to Exhibit 3.1 to the Companys Current Report on Form 8-K filed on November 3, 2006) | |
4.1 | Indenture, dated as of March 31, 2003, between the Company and Wells Fargo Bank Minnesota, National Association (Incorporated by reference to Exhibit 4.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2003) |
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4.2 | Registration Rights Agreement, dated as of March 31, 2003, between the Company and Credit Suisse First Boston, LLC, Banc of America Securities LLC and U.S. Bancorp Piper Jaffray Inc. (Incorporated by reference to Exhibit 4.3 to the Companys Registration Statement on Form S-3 filed on June 30, 2003 (File No. 333-106625)) | |
4.3(a) | Credit Agreement, dated as of December 22, 2005, among Integra LifeSciences Holdings Corporation, the lenders party thereto, Bank of America, N.A., as Administrative Agent, Swing Line Lender and L/C Issuer, Citibank FSB and SunTrust Bank, as Co-Syndication Agents, and Royal Bank of Canada and Wachovia Bank, National Association, as Co-Documentation Agents (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on December 29, 2005) | |
4.3(b) | First Amendment, dated as of February 15, 2006, among Integra LifeSciences Holdings Corporation, the lenders party thereto, Bank of America, N.A., as Administrative Agent, Swing Line Lender and L/C Issuer, Citibank FSB and SunTrust Bank, as Co-Syndication Agents, and Royal Bank of Canada and Wachovia Bank, National Association, as Co-Documentation Agents (Incorporated by reference to Exhibit 4.3(b) to the Companys Annual Report on Form 10-K for the year ended December 31, 2005) | |
4.3(c) | Second Amendment, dated as of February 23, 2007, among Integra LifeSciences Holdings Corporation, the lenders party thereto, Bank of America, N.A., as Administrative Agent, Swing Line Lender and L/C Issuer, Citibank FSB and SunTrust Bank, as Co-Syndication Agents, and Royal Bank of Canada and Wachovia Bank, National Association, as Co-Documentation Agents (Incorporated by reference to Exhibit 4.1 to the Companys Current Report on Form 8-K filed on February 27, 2007) | |
4.4 | Security Agreement, dated as of December 22, 2005, among Integra LifeSciences Holdings Corporation and the additional grantors party thereto in favor of Bank of America, N.A., as administrative and collateral agent (Incorporated by reference to Exhibit 4.4 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005) | |
4.5 | Pledge Agreement, dated as of December 22, 2005, among Integra LifeSciences Holdings Corporation and the additional grantors party thereto in favor of Bank of America, N.A., as administrative and collateral agent (Incorporated by reference to Exhibit 4.5 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005) | |
4.6 | Subsidiary Guaranty Agreement, dated as of December 22, 2005, among the guarantors party thereto and individually as a Guarantor), in favor of Bank of America, N.A., as administrative and collateral agent (Incorporated by reference to Exhibit 4.6 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005) | |
4.7 | Indenture, dated as of September 29, 2006, between the Company and Wells Fargo Bank, N.A. (Incorporated by reference to Exhibit 4.1 to the Companys Current Report on Form 8-K filed on October 5, 2006) | |
10.1(a) | Lease between Plainsboro Associates and American Biomaterials Corporation dated as of April 16, 1985, as assigned to Colla-Tec, Inc. on October 24, 1989 and as amended through November 1, 1992 (Incorporated by reference to Exhibit 10.30 to the Companys Registration Statement on Form 10/A (File No. 0-26224) which became effective on August 8, 1995) | |
10.1(b) | Lease Modification #2 entered into as of the 28th day of October, 2005, by and between Plainsboro Associates and Integra LifeSciences Corporation (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on November 2, 2005) |
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10.2 | Equipment Lease Agreement between Medicus Corporation and the Company, dated as of June 1, 2000 (Incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2000) | |
10.3 | Form of Indemnification Agreement between the Company and [ ] dated August 16, 1995, including a schedule identifying the individuals that are a party to such Indemnification Agreements (Incorporated by reference to Exhibit 10.37 to the Companys Registration Statement on Form S-1 (File No. 33-98698) which became effective on January 24, 1996)* | |
10.4 | 1993 Incentive Stock Option and Non-Qualified Stock Option Plan (Incorporated by reference to Exhibit 10.32 to the Companys Registration Statement on Form 10/A (File No. 0-26224) which became effective on August 8, 1995)* | |
10.5 | 1996 Incentive Stock Option and Non-Qualified Stock Option Plan (as amended through December 27, 1997) (Incorporated by reference to Exhibit 10.4 to the Companys Current Report on Form 8-K filed on February 3, 1998)* | |
10.6 | 1998 Stock Option Plan (amended and restated as of July 26, 2005) (Incorporated by reference to Exhibit 10.3 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2005)* | |
10.7 | 1999 Stock Option Plan (amended and restated as of July 26, 2005) (Incorporated by reference to Exhibit 10.4 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2005)* | |
10.8(a) | Employee Stock Purchase Plan (as amended on May 17, 2004) (Incorporated by reference to Exhibit 4.1 to the Companys Registration Statement on Form S-8 (Registration No. 333-127488) filed on August 12, 2005)* | |
10.8(b) | First Amendment to the Companys Employee Stock Purchase Plan, dated October 26, 2005 (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on November 1, 2005) * | |
10.9 | 2000 Equity Incentive Plan (amended and restated as of July 26, 2005) (Incorporated by reference to Exhibit 10.5 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2005)* | |
10.10 | 2001 Equity Incentive Plan (amended and restated as of July 26, 2005) (Incorporated by reference to Exhibit 10.6 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2005)* | |
10.11 | 2003 Equity Incentive Plan (amended and restated as of July 26, 2005) (Incorporated by reference to Exhibit 10.7 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2005)* | |
10.12(a) | Second Amended and Restated Employment Agreement dated July 27, 2004 between the Company and Stuart M. Essig (Incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2004)* | |
10.12(b) | Amendment 2006-1, dated as of December 19, 2006, to the Second Amended and Restated Employment Agreement, between the Company and Stuart M. Essig (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on December 22, 2006)* |
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10.13 | Indemnity letter agreement dated December 27, 1997 from the Company to Stuart M. Essig (Incorporated by reference to Exhibit 10.5 to the Companys Current Report on Form 8-K filed on February 3, 1998)* | |
10.14(a) | Registration Rights Provisions for Stuart M. Essig (Incorporated by reference to Exhibit B of Exhibit 10.1 to the Companys Current Report on Form 8-K filed on February 3, 1998)* | |
10.14(b) | Registration Rights Provisions for Stuart M. Essig (Incorporated by reference to Exhibit 10.2 to the Companys Current Report on Form 8-K filed on January 8, 2001)* | |
10.14(c) | Registration Rights Provisions for Stuart M. Essig (Incorporated by reference to Exhibit B of Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2004)* | |
10.15 | Amended and Restated 2005 Employment Agreement between John B. Henneman, III and the Company dated December 19, 2005 (Incorporated by reference to Exhibit 10.16 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005)* | |
10.16 | Amended and Restated 2005 Employment Agreement between Gerard S. Carlozzi and the Company dated December 19, 2005 (Incorporated by reference to Exhibit 10.17 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005)* | |
10.17 | Severance Agreement between Judith OGrady and the Company dated January 1, 2007* | |
10.18 | Amended and Restated 2005 Employment Agreement between David B. Holtz and the Company dated December 19, 2005 (Incorporated by reference to Exhibit 10.19 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005)* | |
10.19 | Lease Contract, dated April 1, 2005, between the Puerto Rico Industrial Development Company and Integra CI, Inc. (executed on September 15, 2006) (Incorporated by reference to Exhibit 10.3 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2006) | |
10.20(a) | Industrial Real Estate Triple Net Sublease dated July 1, 2001 between Sorrento Montana, L.P. and Camino NeuroCare, Inc. (Incorporated by reference to Exhibit 10.24(a) to the Companys Annual Report on Form 10-K for the year ended December 31, 2004) | |
10.20(b) | First Amendment to Sublease dated as of July 1, 2003 by and between Sorrento Montana, L.P. and Camino NeuroCare, Inc. (Incorporated by reference to Exhibit 10.24(b) to the Companys Annual Report on Form 10-K for the year ended December 31, 2004) | |
10.20(c) | Second Amendment to Sublease dated as of June 1, 2004 by and between Sorrento Montana, L.P. and Camino NeuroCare, Inc. (Incorporated by reference to Exhibit 10.24(c) to the Companys Annual Report on Form 10-K for the year ended December 31, 2004) | |
10.20(d) | Third Amendment to Sublease dated as of June 15, 2004 by and between Sorrento Montana, L.P. and Integra LifeSciences Corporation (Incorporated by reference to Exhibit 10.24(d) to the Companys Annual Report on Form 10-K for the year ended December 31, 2004) | |
10.21(e) | Fourth Amendment to Sublease, dated as of August 15, 2006, by and between Sorrento Montana, L.P. and Integra LifeSciences Corporation (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on August 17, 2006) | |
10.22 | Restricted Units Agreement dated December 27, 1997 between the Company and Stuart M. Essig (Incorporated by reference to Exhibit 10.3 to the Companys Current Report on Form 8-K filed on February 3, 1998)* |
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10.23 | Stock Option Grant and Agreement dated December 22, 2000 between the Company and Stuart M. Essig (Incorporated by reference to Exhibit 4.1 to the Companys Current Report on Form 8-K filed on January 8, 2001)* | |
10.24 | Stock Option Grant and Agreement dated December 22, 2000 between the Company and Stuart M. Essig (Incorporated by reference to Exhibit 4.2 to the Companys Current Report on Form 8-K filed on January 8, 2001)* | |
10.25(a) | Restricted Units Agreement dated December 22, 2000 Between the Company and Stuart M. Essig (Incorporated by reference to Exhibit 4.3 to the Companys Current Report on Form 8-K filed on January 8, 2001)* | |
10.25(b) | Amendment 2006-1, dated as of October 30, 2006, to the Stuart M. Essig Restricted Units Agreement dated as of December 22, 2000 (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on November 3, 2006)* | |
10.26 | Stock Option Grant and Agreement dated July 27, 2004 between the Company and Stuart M. Essig (Incorporated by reference to Exhibit 10.30 to the Companys Annual Report on Form 10-K for the year ended December 31, 2004)* | |
10.27(a) | Contract Stock/Restricted Units Agreement dated July 27, 2004 between the Company and Stuart M. Essig (Incorporated by reference to Exhibit 10.31 to the Companys Annual Report on Form 10-K for the year ended December 31, 2004)* | |
10.27(b) | Amendment 2006-1, dated as of October 30, 2006, to the Stuart M. Essig Contract Stock/Restricted Units Agreement dated as of July 27, 2004 (Incorporated by reference to Exhibit 10.2 to the Companys Current Report on Form 8-K filed on November 3, 2006)* | |
10.28 | Form of Stock Option Grant and Agreement between the Company and Stuart M. Essig (Incorporated by reference to Exhibit 10.32 to the Companys Annual Report on Form 10-K for the year ended December 31, 2004)* | |
10.29 | Form of Notice of Grant of Stock Option and Stock Option Agreement (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on July 29, 2005)* | |
10.30 | Form of Non-Qualified Stock Option Agreement (Non-Directors) (Incorporated by reference to Exhibit 10.35 to the Companys Annual Report on Form 10-K for the year ended December 31, 2004)* | |
10.31 | Form of Incentive Stock Option Agreement (Incorporated by reference to Exhibit 10.36 to the Companys Annual Report on Form 10-K for the year ended December 31, 2004)* | |
10.32 | Form of Non-Qualified Stock Option Agreement (Directors) (Incorporated by reference to Exhibit 10.37 to the Companys Annual Report on Form 10-K for the year ended December 31, 2004)* | |
10.33 | Compensation of Directors of the Company* | |
10.34 | Form of Restricted Stock Agreement for Non-Employee Directors under the Integra LifeSciences Holdings Corporation 2003 Equity Incentive Plan (Incorporated by reference to Exhibit 10.2 to the Companys Current Report on Form 8-K filed on May 17, 2005)* | |
10.35 | Form of Restricted Stock Agreement for Executive Officers (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on January 9, 2006)* |
48
10.36 | Asset Purchase Agreement, dated as of September 7, 2005, by and between Tyco Healthcare Group LP and Sherwood Services, AG and Integra LifeSciences Corporation and Integra LifeSciences (Ireland) Limited (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on September 13, 2005) | |
10.37 | Restricted Stock Agreement by and between David B. Holtz and the Company dated December 19, 2005 (Incorporated by reference to Exhibit 10.41 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005)* | |
10.38 | Performance Stock Agreement by and between John B. Henneman, III and the Company dated January 3, 2006 (Incorporated by reference to Exhibit 10.42 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005)* | |
10.39 | Performance Stock Agreement by and between Gerard S. Carlozzi and the Company dated January 3, 2006 (Incorporated by reference to Exhibit 10.43 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005)* | |
10.40 | Employment Agreement by and between Maureen B. Bellantoni and the Company dated January 10, 2006 (Incorporated by reference to Exhibit 10.44 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005)* | |
10.41 | Performance Stock Agreement by and between Maureen B. Bellantoni and the Company dated January 10, 2006 (Incorporated by reference to Exhibit 10.45 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005)* | |
10.42 | Stock Purchase Agreement, dated as of April 19, 2006, by and between ASP/Miltex LLC and Integra LifeSciences Corporation (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on April 25, 2006) | |
10.43 | Stock Agreement and Plan of Merger, dated as of June 30, 2006, by and between Integra LifeSciences Corporation, Integra California, Inc., Kinetikos Medical, Inc., Telegraph Hill Partners Management LLC, as Shareholders Representative, and the Shareholders party thereto (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on July 7, 2006) | |
10.44 | Integra LifeSciences Holdings Corporation Management Incentive Compensation Plan (Incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2006)* | |
10.45 | Form of Restricted Stock Agreement for Gerard S. Carlozzi and John B. Henneman, III (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed on February 27, 2007)* | |
21 | Subsidiaries of the Company | |
23 | Consent of PricewaterhouseCoopers LLP | |
31.1 | Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
31.2 | Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
32.1 | Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
32.2 | Certification of Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
* | Indicates a management contract or compensatory plan or arrangement. |
49
INTEGRA LIFESCIENCES HOLDINGS CORPORATION |
||||
Date: March 2, 2007 | By: | /s/ Stuart M. Essig | ||
Stuart M. Essig | ||||
President and Chief Executive Officer | ||||
Signature | Title | Date | ||
/s/ Stuart M. Essig
|
President, Chief Executive Officer and Director (Principal Executive Officer) | March 2, 2007 | ||
/s/ Maureen B. Bellantoni
|
Executive Vice President and Chief Financial Officer (Principal Financial Officer) | March 2, 2007 | ||
/s/ Jerry E. Corbin
|
Vice President and Corporate Controller (Principal Accounting Officer) | March 2, 2007 | ||
/s/ Richard E. Caruso, Ph.D.
|
Chairman of the Board | March 2, 2007 | ||
/s/ Keith Bradley, Ph.D.
|
Director | March 2, 2007 | ||
/s/ Neal Moszkowski
|
Director | March 2, 2007 | ||
/s/ Christian Schade
|
Director | March 2, 2007 | ||
/s/ James M. Sullivan
|
Director | March 2, 2007 | ||
/s/ Anne M. VanLent
|
Director | March 2, 2007 |
50
F-1
F-2
Year Ended December 31, | ||||||||||||
2006 | 2005 | 2004 | ||||||||||
Total revenue, net |
$ | 419,297 | $ | 277,935 | $ | 229,825 | ||||||
COSTS AND EXPENSES |
||||||||||||
Cost of product revenues |
168,314 | 107,052 | 88,496 | |||||||||
Research and development |
25,732 | 11,960 | 14,121 | |||||||||
Selling, general and administrative |
157,706 | 98,273 | 99,360 | |||||||||
Intangible asset amortization |
8,801 | 4,545 | 3,069 | |||||||||
Total costs and expenses |
360,553 | 221,830 | 205,046 | |||||||||
Operating income |
58,744 | 56,105 | 24,779 | |||||||||
Interest income |
2,194 | 3,900 | 4,030 | |||||||||
Interest expense |
(10,620 | ) | (4,165 | ) | (3,475 | ) | ||||||
Other income (expense), net |
(2,010 | ) | (739 | ) | 2,674 | |||||||
Income before income taxes |
48,308 | 55,101 | 28,008 | |||||||||
Provision for income taxes |
18,901 | 17,907 | 10,811 | |||||||||
Net income |
$ | 29,407 | $ | 37,194 | $ | 17,197 | ||||||
Basic net income per share |
$ | 1.00 | $ | 1.23 | $ | 0.57 | ||||||
Diluted net income per share |
$ | .97 | $ | 1.15 | $ | 0.55 | ||||||
Weighted average common shares outstanding: |
||||||||||||
Basic |
29,300 | 30,195 | 30,064 | |||||||||
Diluted |
32,747 | 34,565 | 31,102 |
F-3
Year Ended | ||||||||
December 31, | ||||||||
2006 | 2005 | |||||||
ASSETS |
||||||||
Current Assets: |
||||||||
Cash and cash equivalents |
$ | 22,697 | $ | 46,889 | ||||
Investments in marketable securities |
| 80,327 | ||||||
Trade accounts receivable, net of allowances of $4,114 and $3,508 |
85,018 | 49,007 | ||||||
Inventories, net |
94,387 | 67,476 | ||||||
Deferred tax assets |
10,010 | 10,842 | ||||||
Prepaid expenses and other current assets |
9,649 | 11,411 | ||||||
Total current assets |
221,761 | 265,952 | ||||||
Investments in marketable securities, non-current |
| 16,168 | ||||||
Property, plant, and equipment, net |
42,559 | 27,451 | ||||||
Intangible assets, net |
179,716 | 64,569 | ||||||
Goodwill |
162,414 | 68,364 | ||||||
Other assets |
7,168 | 5,928 | ||||||
Total assets |
$ | 613,618 | $ | 448,432 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current Liabilities: |
||||||||
Borrowings under senior credit facility |
$ | 100,000 | $ | | ||||
Convertible securities |
119,542 | | ||||||
Accounts payable, trade |
20,329 | 8,978 | ||||||
Income taxes payable |
| 715 | ||||||
Deferred revenue |
4,319 | 88 | ||||||
Accrued compensation |
12,454 | 8,761 | ||||||
Accrued expenses and other current liabilities |
17,373 | 12,745 | ||||||
Total current liabilities |
274,017 | 31,287 | ||||||
Long-term convertible securities |
508 | 118,378 | ||||||
Deferred tax liabilities |
31,356 | 2,520 | ||||||
Other liabilities |
11,575 | 6,429 | ||||||
Total liabilities |
317,456 | 158,614 | ||||||
Commitments and contingencies |
||||||||
Stockholders Equity: |
||||||||
Preferred Stock; no par value; 15,000,000 authorized shares; none
outstanding |
| | ||||||
Common stock; $.01 par value; 60,000 authorized shares; 31,464 and
29,823 issued |
315 | 298 | ||||||
Additional paid-in capital |
367,277 | 333,179 | ||||||
Treasury stock, at cost; 4,147 and 2,368 shares |
(145,846 | ) | (75,815 | ) | ||||
Accumulated other comprehensive income (loss): |
||||||||
Unrealized gain (loss) on available-for-sale securities, net of tax |
| (801 | ) | |||||
Foreign currency translation adjustment |
10,045 | (2,300 | ) | |||||
Pension liability adjustment, net of tax |
(1,965 | ) | (1,672 | ) | ||||
Retained earnings |
66,336 | 36,929 | ||||||
Total stockholders equity |
296,162 | 289,818 | ||||||
Total liabilities and stockholders equity |
$ | 613,618 | $ | 448,432 | ||||
F-4
Year Ended December 31, | ||||||||||||
2006 | 2005 | 2004 | ||||||||||
OPERATING ACTIVITIES: |
||||||||||||
Net income |
$ | 29,407 | $ | 37,194 | $ | 17,197 | ||||||
Adjustments to reconcile net income to net cash provided by
operating activities: |
||||||||||||
Depreciation and amortization |
19,018 | 11,313 | 9,087 | |||||||||
In-process research and development |
5,875 | 500 | | |||||||||
Loss on sale of assets/investments |
755 | | (55 | ) | ||||||||
Amortization of bond issuance costs |
2,096 | 820 | 821 | |||||||||
Excess tax benefits from stock-based compensation arrangements |
(1,335 | ) | | | ||||||||
Deferred income tax provision |
3,235 | 9,895 | 6,101 | |||||||||
Amortization of discount/premium on investments |
364 | 1,908 | 2,505 | |||||||||
Share-based compensation |
14,115 | 146 | 23,572 | |||||||||
Other, net |
336 | (41 | ) | (70 | ) | |||||||
Changes in assets and liabilities, net of business acquisitions: |
||||||||||||
Accounts receivable |
(26,131 | ) | 491 | (13,287 | ) | |||||||
Inventories |
3,461 | (9,984 | ) | (9,738 | ) | |||||||
Prepaid expenses and other current assets |
(2,465 | ) | 30 | (1,949 | ) | |||||||
Other non-current assets |
(799 | ) | (66 | ) | (169 | ) | ||||||
Accounts payable, accrued expenses and other liabilities |
14,011 | (1,494 | ) | 2,118 | ||||||||
Income taxes payable |
7,496 | 6,294 | 3,911 | |||||||||
Deferred revenue |
2,409 | (158 | ) | (110 | ) | |||||||
Other liabilities |
(146 | ) | | (959 | ) | |||||||
Net cash provided by operating activities |
71,702 | 56,848 | 38,975 | |||||||||
INVESTING ACTIVITIES: |
||||||||||||
Proceeds from the sales of investments |
109,872 | 93,315 | 241,440 | |||||||||
Proceeds from sales of property and equipment |
689 | | | |||||||||
Purchases of available for sale investments |
(13,074 | ) | (65,499 | ) | (190,888 | ) | ||||||
Purchases of property and equipment |
(11,520 | ) | (8,053 | ) | (8,508 | ) | ||||||
Cash used in acquisitions, net of cash acquired |
(228,662 | ) | (50,602 | ) | (29,302 | ) | ||||||
Net cash (used in)/provided by investing activities |
(142,695 | ) | (30,839 | ) | 12,742 | |||||||
FINANCING ACTIVITIES: |
||||||||||||
Borrowings under senior credit facility |
162,000 | | | |||||||||
Fees paid in connection with bank line of credit |
| (1,132 | ) | | ||||||||
Repayment of bank loans |
(63,530 | ) | (245 | ) | | |||||||
Proceeds from exercised stock options and warrants |
15,867 | 9,382 | 6,123 | |||||||||
Purchases of treasury stock |
(70,031 | ) | (56,341 | ) | (14,238 | ) | ||||||
Excess tax benefits from stock-based compensation arrangements |
1,335 | | | |||||||||
Net cash provided by (used in) financing activities |
45,641 | (48,336 | ) | (8,115 | ) | |||||||
Effect of exchange rate changes on cash and cash equivalents |
1,160 | (639 | ) | 199 | ||||||||
Net (decrease) increase in cash and cash equivalents |
(24,192 | ) | (22,966 | ) | 43,801 | |||||||
Cash and cash equivalents at beginning of period |
46,889 | 69,855 | 26,054 | |||||||||
Cash and cash equivalents at end of period |
$ | 22,697 | $ | 46,889 | $ | 69,855 | ||||||
Cash paid during the year for interest |
$ | 8,060 | $ | 3,275 | $ | 2,331 | ||||||
Cash paid during the year for income taxes |
16,395 | 7,721 | 1,789 | |||||||||
Supplemental non-cash disclosure: |
||||||||||||
Acquisition fees included in liabilities |
$ | | $ | 1,123 | $ | | ||||||
Property and equipment purchases included in liabilities |
765 | 199 | 969 |
F-5
Accumu- | |||||||||||||||||||||||||||||||||
lated | Retained | ||||||||||||||||||||||||||||||||
Other | Earnings / | ||||||||||||||||||||||||||||||||
Additional | Compre- | (Accumu- | |||||||||||||||||||||||||||||||
Preferred | Common | Treasury | Paid-In | hensive | lated | Total | |||||||||||||||||||||||||||
Stock | Stock | Stock | Capital | Other | Income (Loss) | Deficit) | Equity | ||||||||||||||||||||||||||
Balance, December 31, 2003 |
$ | | $ | 286 | $ | (5,236 | ) | $ | 286,716 | $ | (5 | ) | $ | 4,231 | $ | (17,462 | ) | $ | 268,530 | ||||||||||||||
Net income |
17,197 | 17,197 | |||||||||||||||||||||||||||||||
Realized gains on investments |
88 | 88 | |||||||||||||||||||||||||||||||
Unrealized losses on investments,
net of tax |
(969 | ) | (969 | ) | |||||||||||||||||||||||||||||
Foreign currency translation |
3,683 | 3,683 | |||||||||||||||||||||||||||||||
Minimum pension liability
adjustment, net of tax |
(365 | ) | (365 | ) | |||||||||||||||||||||||||||||
Total comprehensive income |
$ | 19,634 | |||||||||||||||||||||||||||||||
Issuance of 592 shares of common
stock through employee benefit plans |
6 | 6,492 | 6,498 | ||||||||||||||||||||||||||||||
Issuance of contract stock unit
award for 750 shares of common stock |
23,535 | 23,535 | |||||||||||||||||||||||||||||||
Other share-based compensation |
30 | 5 | 35 | ||||||||||||||||||||||||||||||
Tax benefit related to stock option
exercises |
3,829 | 3,829 | |||||||||||||||||||||||||||||||
Repurchase 500 shares of common stock |
(14,238 | ) | (14,238 | ) | |||||||||||||||||||||||||||||
Balance, December 31, 2004 |
$ | | $ | 292 | $ | (19,474 | ) | $ | 320,602 | $ | | $ | 6,668 | $ | (265 | ) | $ | 307,823 | |||||||||||||||
Net income |
37,194 | 37,194 | |||||||||||||||||||||||||||||||
Realized gains on investments |
18 | 18 | |||||||||||||||||||||||||||||||
Unrealized losses on investments,
net of tax |
(1 | ) | (1 | ) | |||||||||||||||||||||||||||||
Foreign currency translation |
(11,375 | ) | (11,375 | ) | |||||||||||||||||||||||||||||
Minimum pension liability
adjustment, net of tax |
(83 | ) | (83 | ) | |||||||||||||||||||||||||||||
Total comprehensive income |
$ | 25,753 | |||||||||||||||||||||||||||||||
Issuance of 621 shares of common
stock through employee benefit plans |
6 | 9,170 | 9,176 | ||||||||||||||||||||||||||||||
Share-based compensation |
146 | 146 | |||||||||||||||||||||||||||||||
Tax benefit related to stock option
exercises |
3,261 | 3,261 | |||||||||||||||||||||||||||||||
Repurchase 1,650 shares of common
stock |
(56,341 | ) | (56,341 | ) | |||||||||||||||||||||||||||||
Balance, December 31, 2005 |
$ | | $ | 298 | $ | (75,815 | ) | $ | 333,179 | $ | | $ | (4,773 | ) | $ | 36,929 | $ | 289,818 | |||||||||||||||
Net income |
29,407 | 29,407 | |||||||||||||||||||||||||||||||
Realized gains on investments |
254 | 254 | |||||||||||||||||||||||||||||||
Reversal of unrealized losses on
investments, net of tax |
547 | 547 | |||||||||||||||||||||||||||||||
Foreign currency translation |
12,345 | 12,345 | |||||||||||||||||||||||||||||||
Pension liability
adjustment, net of tax |
(293 | ) | (293 | ) | |||||||||||||||||||||||||||||
Total comprehensive income |
$ | 42,260 | |||||||||||||||||||||||||||||||
Issuance of
1,649 shares of common
stock through employee benefit plans |
17 | 15,888 | 15,905 | ||||||||||||||||||||||||||||||
Tax benefit related to stock option exercises |
3,237 | 3,237 | |||||||||||||||||||||||||||||||
Share-based compensation |
14,973 | 14,973 | |||||||||||||||||||||||||||||||
Repurchase 1,779 shares of common
stock |
(70,031 | ) | (70,031 | ) | |||||||||||||||||||||||||||||
Balance, December 31, 2006 |
$ | | $ | 315 | $ | (145,846 | ) | $ | 367,277 | $ | | $ | 8,080 | $ | 66,336 | $ | 296,162 | ||||||||||||||||
F-6
F-7
Unrealized | ||||||||||||||||
Cost | Gains | Losses | Fair Value | |||||||||||||
(in thousands) | ||||||||||||||||
2005 |
||||||||||||||||
Marketable Securities, current |
||||||||||||||||
Corporate Debt Securities |
$ | 37,248 | $ | | $ | (372 | ) | $ | 36,876 | |||||||
Auction Rate Securities |
2,650 | | | 2,650 | ||||||||||||
U.S. Government Debt Securities |
39,201 | | (427 | ) | 38,774 | |||||||||||
Other Securities |
2,054 | | (27 | ) | 2,027 | |||||||||||
Total marketable securities, current |
$ | 81,153 | $ | | $ | (826 | ) | $ | 80,327 | |||||||
Marketable Securities, non-current |
||||||||||||||||
Corporate Debt Securities |
$ | 10,330 | $ | | $ | (277 | ) | $ | 10,053 | |||||||
U.S. Government Debt Securities |
6,252 | | (137 | ) | 6,115 | |||||||||||
Total marketable securities, non-current |
$ | 16,582 | $ | | $ | (414 | ) | $ | 16,168 | |||||||
F-8
December 31, | ||||||||
2006 | 2005 | |||||||
(in thousands) | ||||||||
Finished goods |
$ | 74,324 | $ | 51,970 | ||||
Work in process |
14,416 | 9,895 | ||||||
Raw materials |
20,433 | 15,379 | ||||||
Less: reserves |
(14,786 | ) | (9,768 | ) | ||||
Total inventories, net |
$ | 94,387 | $ | 67,476 | ||||
F-9
December 31 | ||||||||||||
2006 | 2005 | Lives | ||||||||||
(in thousands) | ||||||||||||
Land |
$ | 1,405 | $ | 890 | ||||||||
Buildings |
3,762 | 3,433 | 30-40 years | |||||||||
Leasehold improvements |
18,364 | 11,775 | 2-22 years | |||||||||
Machinery and equipment |
26,108 | 20,732 | 2-15 years | |||||||||
Furniture, fixtures and information systems |
25,279 | 15,310 | 3-10 years | |||||||||
Construction in progress |
5,818 | 2,007 | ||||||||||
Total |
80,736 | 54,147 | ||||||||||
Less: Accumulated depreciation |
(38,177 | ) | (26,696 | ) | ||||||||
$ | 42,559 | $ | 27,451 | |||||||||
2006 | 2005 | |||||||
(in thousands) | ||||||||
Goodwill, beginning of year |
$ | 68,364 | $ | 39,237 | ||||
Radionics acquisition |
21,054 | | ||||||
Newdeal working capital adjustment |
694 | | ||||||
Miltex acquisition |
43,018 | | ||||||
Kinetikos Medical acquisition |
23,089 | | ||||||
Newdeal acquisition |
| 35,668 | ||||||
Foreign currency translation and other |
6,195 | (6,541 | ) | |||||
Goodwill, end of year |
$ | 162,414 | $ | 68,364 | ||||
F-10
Weighted | December 31, 2006 | December 31, 2005 | ||||||||||||||||||||||||||
Average | Accumulated | Accumulated | ||||||||||||||||||||||||||
Life | Cost | Amortization | Net | Cost | Amortization | Net | ||||||||||||||||||||||
Completed technology |
13 years | $ | 35,632 | $ | (8,573 | ) | $ | 27,059 | $ | 18,921 | $ | (5,691 | ) | $ | 13,230 | |||||||||||||
Customer relationships |
12 years | 67,872 | (10,671 | ) | 57,201 | 22,550 | (4,823 | ) | 17,727 | |||||||||||||||||||
Trademarks/brand names |
34 years | 35,350 | (4,029 | ) | 31,321 | 31,175 | (2,802 | ) | 28,373 | |||||||||||||||||||
Trademarks/brand names |
Indefinite | 31,600 | | 31,600 | | | | |||||||||||||||||||||
Noncompetition agreement |
5 years | 7,151 | (4,079 | ) | 3,072 | 6,943 | (2,607 | ) | 4,336 | |||||||||||||||||||
Supplier relationships |
30 years | 29,300 | (620 | ) | 28,680 | |||||||||||||||||||||||
All other |
15 years | 1,620 | (837 | ) | 783 | 2,233 | (1,330 | ) | 903 | |||||||||||||||||||
$ | 208,525 | $ | (28,809 | ) | $ | 179,716 | $ | 81,822 | $ | (17,253 | ) | $ | 64,569 | |||||||||||||||
F-11
F-12
December 31, | ||||||||
2006 | 2005 | |||||||
(in thousands) | ||||||||
Beginning balance |
$ | 696 | $ | 748 | ||||
Liability acquired through acquisition |
358 | | ||||||
Charged to expense |
300 | 191 | ||||||
Deductions |
(29 | ) | (243 | ) | ||||
$ | 1,325 | $ | 696 | |||||
F-13
F-14
Year ended December 31, 2006 | ||||
(in thousands, except per share amounts) | ||||
Research and development expense |
$ | 639 | ||
Selling, general and administrative |
13,161 | |||
Amortization of amounts previously capitalized to inventory |
315 | |||
Total employee stock-based compensation expense |
14,115 | |||
Tax benefit related to employee stock-based compensation
expense |
4,550 | |||
Net effect on net income |
$ | 9,565 | ||
Effect on earnings per share: |
||||
Basic |
$ | 0.33 | ||
Diluted |
$ | 0.29 |
Fiscal year ended December 31, | ||||||||
2005 | 2004 | |||||||
(in thousands, except per share amounts) | ||||||||
Net income: |
||||||||
As reported |
$ | 37,194 | $ | 17,197 | ||||
Add back: Total
share-based employee
compensation expense
determined under the
intrinsic value-based
method for all awards,
net of related tax
effects |
103 | 15,372 | ||||||
Less: Total share-based
employee compensation
expense determined under
the fair value-based
method for all awards,
net of related tax
effects |
(7,264 | ) | (21,799 | ) | ||||
Pro forma |
$ | 30,033 | $ | 10,770 | ||||
Net income per share: |
||||||||
Basic |
||||||||
As reported |
$ | 1.23 | $ | 0.57 | ||||
Pro forma |
$ | 0.99 | $ | 0.36 | ||||
Diluted |
||||||||
As reported |
$ | 1.15 | $ | 0.55 | ||||
Pro forma |
$ | 0.94 | $ | 0.35 |
F-15
2006 | 2005 | 2004 | ||||||||||
Dividend yield |
0 | % | 0 | % | 0 | % | ||||||
Expected volatility |
39 | %(1) | 43 | % | 48 | % | ||||||
Risk free interest rate |
4.3 to 5.1 | %(2) | 3.8 | % | 3.2 | % | ||||||
Expected life of option from grant date |
6.1 years | 5.4 years | 4.7 years |
(1) | A volatility rate of 39% in 2006 that decreases 1% in each subsequent year for the length of
the term was used. |
|
(2) | Risk free interest rates ranged based on the duration of the grant. |
F-16
F-17
Inventory |
$ | 8,201 | ||||||
Property, plant and equipment |
1,365 | |||||||
Wtd. Avg. Life | ||||||||
Intangible Assets: |
||||||||
Tradename |
18,100 | Indefinite | ||||||
Customer relationships |
20,900 | 7 years | ||||||
Technology |
10,000 | 10 years | ||||||
Goodwill |
21,054 | |||||||
Other Assets |
72 | |||||||
Total assets acquired |
79,692 | |||||||
Accrued expenses and other current liabilities |
425 | |||||||
Deferred revenue |
1,605 | |||||||
Total liabilities assumed |
2,030 | |||||||
Net assets acquired |
$ | 77,662 | ||||||
F-18
Inventory |
$ | 16,775 | ||||||
Other current assets |
8,049 | |||||||
Property, plan and equipment |
7,699 | |||||||
Wtd. Avg. Life | ||||||||
Intangible Assets: |
||||||||
Customer relationships |
13,100 | 15 years | ||||||
Tradename (Miltex) |
13,500 | Indefinite | ||||||
Tradename (Moyco, Union Broach, Thompson) |
300 | 4 years | ||||||
Tradename (other product lines) |
600 | 15 years | ||||||
Technology |
1,100 | 10 years | ||||||
Supplier relationships |
29,300 | 30 years | ||||||
Goodwill |
43,018 | |||||||
Other Assets |
219 | |||||||
Total assets acquired |
133,660 | |||||||
Accrued expenses and other current liabilities |
3,988 | |||||||
Deferred tax liabilities |
20,674 | |||||||
Other non-current liabilities |
5,667 | |||||||
Total liabilities assumed |
30,329 | |||||||
Net assets acquired |
$ | 103,331 | ||||||
F-19
Inventory |
$ | 1,576 | ||||||
Other current Assets |
1,121 | |||||||
Wtd. Avg. Life | ||||||||
Intangible Assets: |
||||||||
Customer relationships |
4,722 | 10 years | ||||||
Tradename |
2,756 | 15 years | ||||||
Non-compete |
90 | 5 years | ||||||
Goodwill |
| |||||||
Other Assets |
21 | |||||||
Total assets acquired |
10,286 | |||||||
Accrued expenses and other current liabilities |
730 | |||||||
Deferred liabilities |
671 | |||||||
Deferred tax liabilities |
2,737 | |||||||
Total liabilities assumed |
4,138 | |||||||
Net assets acquired |
$ | 6,148 | ||||||
F-20
Inventory |
$ | 2,208 | ||||||
Other current Assets |
2,801 | |||||||
Property, plant and equipment |
1,646 | |||||||
Wtd. Avg. Life | ||||||||
Intangible Assets: |
||||||||
Customer relationships |
6,100 | 3.5 years | ||||||
Tradename (MBA, UNI2) |
300 | 5 years | ||||||
Developed technology patents |
4,350 | 15 years | ||||||
In-process research and development |
5,875 | Expensed immediately | ||||||
Goodwill |
23,089 | |||||||
Other Assets |
1,260 | |||||||
Total assets acquired |
47,629 | |||||||
Accrued expenses and other current liabilities |
1,933 | |||||||
Deferred tax liabilities |
3,953 | |||||||
Total liabilities assumed |
5,886 | |||||||
Net assets acquired |
$ | 41,743 | ||||||
F-21
F-22
Newdeal | ||||
(All amounts in thousands) | ||||
2005 Acquisitions |
||||
Current assets |
$ | 10,925 | ||
Property, plant and equipment |
1,026 | |||
Intangible assets |
13,090 | |||
Goodwill |
35,668 | |||
Other assets |
38 | |||
Total assets acquired |
60,747 | |||
Liabilities assumed, excluding debt |
7,560 | |||
Debt assumed |
530 | |||
Net assets acquired |
$ | 52,657 | ||
Amount | Estimated useful life | |||||||
Tradename |
$ | 2,926 | 37 years | |||||
Customer relationships |
6,032 | 10 years | ||||||
Technology |
3,387 | 10 years | ||||||
Non-competition agreement |
745 | 5 years |
MAYFIELD / BUDDE |
Integra ME | R&B / Sparta | ||||||||||
2004 Acquisitions
|
||||||||||||
Current assets |
$ | 3,489 | $ | 3,151 | $ | 817 | ||||||
Property, plant and equipment |
1,400 | 78 | 10 | |||||||||
Intangible assets |
8,030 | 1,320 | 1,639 | |||||||||
Goodwill |
8,397 | 1,775 | 1,478 | |||||||||
Total assets acquired |
21,316 | 6,324 | 3,944 | |||||||||
Current liabilities |
768 | 837 | 340 | |||||||||
Deferred tax liabilities |
| 240 | | |||||||||
Other non-current liabilities |
| 265 | | |||||||||
Total liabilities assumed |
768 | 1,342 | 340 | |||||||||
Net assets acquired |
$ | 20,548 | $ | 4,982 | $ | 3,604 | ||||||
F-23
2006 | 2005 | |||||||
(in thousands, except per share amounts) | ||||||||
Total revenue, net |
$ | 462,593 | $ | 414,785 | ||||
Net income |
32,903 | 35,312 | ||||||
Basic net income per share |
$ | 1.12 | $ | 1.17 | ||||
Diluted net income per share |
$ | 1.07 | $ | 1.09 |
F-24
Research and | Selling, General | |||||||||||||||
Cost of Sales | Development | and Administrative | Total | |||||||||||||
(in thousands) | ||||||||||||||||
2006 |
||||||||||||||||
Involuntary employee termination costs |
$ | 290 | $ | | $ | 745 | $ | 1,035 | ||||||||
Facility exit costs |
| | | | ||||||||||||
2005 |
||||||||||||||||
Involuntary employee termination costs |
$ | 2,596 | $ | 183 | $ | 1,082 | $ | 3,861 | ||||||||
Facility exit costs |
| | 155 | 155 |
Employee | ||||||||||||
Termination | Facility Exit | |||||||||||
Costs | Costs | Total | ||||||||||
(in thousands) | ||||||||||||
Balance at December 31, 2005 |
$ | | $ | | $ | | ||||||
Additions |
4,010 | 155 | 4,165 | |||||||||
Reversal of prior accruals |
(149 | ) | | (149 | ) | |||||||
Payments |
(1,398 | ) | (31 | ) | (1,429 | ) | ||||||
Effects of foreign exchange |
(43 | ) | | (43 | ) | |||||||
Balance at December 31, 2005 |
2,420 | 124 | 2,544 | |||||||||
Additions |
1,035 | | 1,035 | |||||||||
Acquired through acquisition |
220 | 155 | 375 | |||||||||
Reversal of prior accruals |
(116 | ) | | (116 | ) | |||||||
Payments |
(2,107 | ) | (118 | ) | (2,225 | ) | ||||||
Effects of foreign exchange |
104 | 9 | 113 | |||||||||
Balance at December 31, 2006 |
$ | 1,556 | $ | 170 | $ | 1,726 | ||||||
F-25
F-26
F-27
2006 | 2005 | 2004 | ||||||||||
(in thousands) | ||||||||||||
Interest rate swap |
$ | (690 | ) | $ | 690 | $ | 287 | |||||
Contingent convertible notes |
343 | (821 | ) | (430 | ) | |||||||
Net increase (decrease) in liabilities |
347 | $ | (131 | ) | $ | (143 | ) | |||||
F-28
Shares | Weighted Average | |||||||
Stock Options | (in thousands) | Exercise Price | ||||||
Outstanding at December 31, 2003 |
2,884 | $ | 16.19 | |||||
Granted |
1,473 | 31.81 | ||||||
Exercised |
(547 | ) | 9.80 | |||||
Forfeited or Expired |
(127 | ) | 21.97 | |||||
Outstanding at December 31, 2004 |
3,683 | 23.42 | ||||||
Granted |
1,089 | 34.53 | ||||||
Exercised |
(576 | ) | 13.83 | |||||
Forfeited or Expired |
(195 | ) | 30.28 | |||||
Outstanding at December 31, 2005 |
4,001 | 27.50 | ||||||
Granted |
273 | 40.75 | ||||||
Exercised |
(705 | ) | 22.20 | |||||
Forfeited or Expired |
(131 | ) | 33.27 | |||||
Outstanding at December 31, 2006 |
3,438 | $ | 29.41 |
F-29
Options Outstanding | ||||||||||||||||||||
Weighted Avg. | Options Exercisable | |||||||||||||||||||
Shares (in | Weighted Avg. | Remaining | Shares (in | Weighted Avg. | ||||||||||||||||
Range of Exercise Prices | thousands) | Exercise Price | Contractual Life | thousands) | Exercise Price | |||||||||||||||
$11.00 to $16.07 |
348 | $ | 11.81 | 3.43 | 348 | $ | 11.81 | |||||||||||||
$16.13 to $22.95 |
346 | 18.90 | 1.98 | 337 | 18.83 | |||||||||||||||
$23.80 to $27.32 |
349 | 26.58 | 1.11 | 329 | 26.54 | |||||||||||||||
$27.47 to $29.24 |
363 | 28.65 | 2.95 | 261 | 28.58 | |||||||||||||||
$29.32 to $31.38 |
481 | 30.86 | 5.98 | 226 | 31.03 | |||||||||||||||
$31.89 to $34.49 |
497 | 33.57 | 5.73 | 260 | 33.52 | |||||||||||||||
$34.62 to $35.57 |
492 | 35.48 | 6.01 | 190 | 35.46 | |||||||||||||||
$35.76 to $38.20 |
347 | 36.65 | 4.25 | 150 | 36.63 | |||||||||||||||
$38.72 to $42.53 |
216 | 42.25 | 9.54 | 7 | 38.72 | |||||||||||||||
Amounts as of December
31, 2006 |
3,438 | $ | 29.41 | 2,108 | $ | 26.04 | ||||||||||||||
Amounts as of December
31, 2005 |
4,001 | $ | 27.50 | 2,023 | $ | 22.74 | ||||||||||||||
Amounts as of December
31, 2004 |
3,683 | $ | 23.42 | 1,641 | $ | 17.61 |
Performance Stock and Contract | ||||||||||||||||
Restricted Stock Awards | Stock Awards | |||||||||||||||
Wtd. Avg. Fair | Wtd. Avg. Fair | |||||||||||||||
Shares | Value Per Share | Shares | Value Per Share | |||||||||||||
Unvested, December 31, 2005 |
19 | $ | 35.08 | | $ | | ||||||||||
Granted |
194 | 38.38 | 218 | 35.41 | ||||||||||||
Cancellations |
(11 | ) | 38.18 | | | |||||||||||
Unvested, December 31, 2006 |
202 | $ | 38.08 | 218 | $ | 35.41 | ||||||||||
F-30
2006 | 2005 | 2004 | ||||||||||||||
(in thousands) | ||||||||||||||||
Non-U.S. | Non-U.S. | Non-U.S. | ||||||||||||||
U.S. Plan | Plans | Plans | Plans | |||||||||||||
Service cost |
$ | | $ | 182 | $ | 178 | $ | 179 | ||||||||
Interest cost |
25 | 585 | 567 | 522 | ||||||||||||
Expected return on plan assets |
(24 | ) | (483 | ) | (464 | ) | (434 | ) | ||||||||
Recognized net actuarial loss |
28 | 337 | 215 | 203 | ||||||||||||
Net periodic benefit cost,
before settlement expenses |
29 | 621 | 496 | 470 | ||||||||||||
Settlement expense |
53 | | | | ||||||||||||
Net periodic benefit cost |
$ | 82 | $ | 621 | $ | 496 | $ | 470 | ||||||||
F-31
2006 | 2005 | 2004 | ||||||||||||||
U.S. Plan | Non-U.S. Plans | Non-U.S. Plans | Non-U.S. Plans | |||||||||||||
Discount rate |
5.5 | % | 5.2 | % | 4.7 | % | 5.2 | % | ||||||||
Expected return on plan assets |
7.0 | % | 5.7 | % | 4.9 | % | 5.8 | % | ||||||||
Rate of compensation increase |
N/A | 3.1 | % | 3.5 | % | 3.3 | % |
December 31, | ||||||||||||
2006 | 2005 | |||||||||||
U.S. Plan | Non-U.S. Plans | Non-U.S. Plans | ||||||||||
(in thousands) | ||||||||||||
CHANGE IN PROJECTED BENEFIT OBLIGATION |
||||||||||||
Projected benefit obligation, beginning of year |
$ | | $ | 11,647 | $ | 11,367 | ||||||
Service cost |
182 | 178 | ||||||||||
Interest cost |
25 | 585 | 567 | |||||||||
Participant contributions |
33 | 36 | ||||||||||
Benefits paid |
(425 | ) | (317 | ) | ||||||||
Actuarial (gain) loss |
13 | 211 | 1,133 | |||||||||
Settlements |
(104 | ) | | | ||||||||
Acquisitions |
503 | | | |||||||||
Effect of foreign currency exchange rates |
| 1,637 | (1,315 | ) | ||||||||
Projected benefit obligation, end of year |
$ | 437 | $ | 13,870 | $ | 11,649 | ||||||
F-32
December 31, | ||||||||||||
2006 | 2005 | |||||||||||
U.S. Plan | Non-U.S. Plans | Non-U.S. Plans | ||||||||||
(in thousands) | ||||||||||||
CHANGE IN PLAN ASSETS |
||||||||||||
Plan assets at fair value, beginning of year |
$ | | $ | 8,673 | $ | 8,379 | ||||||
Actual return on plan assets |
24 | 440 | 1,277 | |||||||||
Employer contributions |
57 | 278 | 264 | |||||||||
Participant contributions |
| 33 | 36 | |||||||||
Benefits paid |
(104 | ) | (333 | ) | (315 | ) | ||||||
Acquisitions |
363 | | | |||||||||
Effect of foreign currency exchange rates |
| 1,224 | (968 | ) | ||||||||
Plan assets at fair value, end of year |
$ | 340 | $ | 10,315 | $ | 8,673 | ||||||
RECONCILIATION OF FUNDED STATUS |
||||||||||||
Funded status, projected benefit obligation in
excess of plan assets |
$ | (97 | ) | $ | (3,555 | ) | $ | (2,976 | ) | |||
Unrecognized net actuarial loss |
223 | 2,584 | 2,504 | |||||||||
Additional minimum liability |
| | (2,390 | ) | ||||||||
Accumulated other comprehensive income under FAS 158 |
(223 | ) | (2,584 | ) | | |||||||
Accrued benefit cost |
$ | (97 | ) | $ | (3,555 | ) | $ | (2,862 | ) | |||
December 31, | ||||||||||||
2006 | 2005 | |||||||||||
U.S. Plan | Non-U.S. Plans | Non-U.S. Plans | ||||||||||
Equity securities |
61 | % | 46 | % | 47 | % | ||||||
Corporate bonds |
| 32 | % | 26 | % | |||||||
Government bonds |
36 | % | 18 | % | 20 | % | ||||||
Insurance contracts |
| 3 | % | 2 | % | |||||||
Cash |
3 | % | 1 | % | 5 | % | ||||||
100 | % | 100 | % | 100 | % | |||||||
2007 |
$ | 506,000 | ||
2008 |
529,000 | |||
2009 |
553,000 | |||
2010 |
629,000 | |||
2011 |
677,000 | |||
2012-2016 |
$ | 4,223,000 |
F-33
Related Parties | Third Parties | Total | ||||||||||
(in thousands) | ||||||||||||
2007 |
$ | 324 | $ | 3,772 | $ | 4,096 | ||||||
2008 |
341 | 2,654 | 2,995 | |||||||||
2009 |
341 | 1,896 | 2,237 | |||||||||
2010 |
296 | 729 | 1,025 | |||||||||
2011 |
251 | 621 | 872 | |||||||||
Thereafter |
4,525 | 2,664 | 7,189 | |||||||||
Total minimum lease payments |
$ | 6,078 | $ | 12,336 | $ | 18,414 | ||||||
F-34
2006 | 2005 | 2004 | ||||||||||
(in thousands) | ||||||||||||
Current: |
||||||||||||
Federal |
$ | 7,454 | $ | 2,547 | $ | 1,899 | ||||||
State |
1,332 | 2,038 | 1,670 | |||||||||
Foreign |
6,880 | 3,427 | 1,141 | |||||||||
Total current |
15,666 | 8,012 | 4,710 | |||||||||
Deferred: |
||||||||||||
Federal |
$ | 2,049 | $ | 13,706 | $ | 5,802 | ||||||
State |
(256 | ) | (409 | ) | 53 | |||||||
Foreign |
1,442 | (3,402 | ) | 246 | ||||||||
Total deferred |
3,235 | 9,895 | 6,101 | |||||||||
Provision for income taxes |
$ | 18,901 | $ | 17,907 | $ | 10,811 | ||||||
2006 | 2005 | 2004 | ||||||||||
(in thousands) | ||||||||||||
United States operations |
$ | 20,000 | $ | 46,111 | $ | 17,074 | ||||||
Foreign operations |
28,308 | 8,990 | 10,934 | |||||||||
Total |
$ | 48,308 | $ | 55,101 | $ | 28,008 | ||||||
December 31, | ||||||||
2006 | 2005 | |||||||
(in thousands) | ||||||||
Net operating loss and tax credit carryforwards |
$ | 1,258 | $ | 4,622 | ||||
Inventory reserves and capitalization |
7,242 | 4,781 | ||||||
Deferred compensation |
14,582 | 14,053 | ||||||
Deferred income |
961 | 3,831 | ||||||
Total deferred tax assets before valuation allowance |
24,043 | 27,287 | ||||||
Valuation allowance |
(1,632 | ) | (5,126 | ) | ||||
Depreciation and amortization |
(35,506 | ) | (9,694 | ) | ||||
Other |
(8,251 | ) | (4,145 | ) | ||||
Net deferred tax assets (liability) |
$ | (21,346 | ) | $ | 8,322 | |||
F-35
2006 | 2005 | 2004 | ||||||||||
Federal statutory rate |
35.0 | % | 35.0 | % | 35.0 | % | ||||||
Increase (reduction) in income taxes resulting from: |
||||||||||||
State income taxes, net of federal tax benefit |
1.9 | % | 2.0 | % | 4.0 | % | ||||||
Foreign taxes booked at different rates |
(1.6 | %) | (3.7 | %) | (4.2 | %) | ||||||
Foreign losses |
| (0.9 | %) | | ||||||||
Tax on asset transfer |
| | 4.5 | % | ||||||||
In-process research and development |
4.3 | % | | | ||||||||
Incentive Stock Option expense |
1.4 | % | | | ||||||||
Adjustments to net operating losses |
(1.8 | %) | | | ||||||||
Compensation in excess of IRS deductible limits |
2.5 | % | | | ||||||||
Decrease in valuation allowances |
(2.5 | %) | | | ||||||||
Other |
(0.1 | %) | 0.1 | % | (0.7 | %) | ||||||
Effective tax rate |
39.1 | % | 32.5 | % | 38.6 | % | ||||||
F-36
2006 | 2005 | 2004 | ||||||||||
(in thousands, except per share amounts) | ||||||||||||
Basic: |
||||||||||||
Net income |
$ | 29,407 | $ | 37,194 | $ | 17,197 | ||||||
Basic net income per share |
$ | 1.00 | $ | 1.23 | $ | 0.57 | ||||||
Weighted average common shares outstanding Basic |
29,300 | 30,195 | 30,064 | |||||||||
Diluted: |
||||||||||||
Net income |
$ | 29,407 | $ | 37,194 | $ | 17,197 | ||||||
Add back: Interest expense and other
income related to convertible notes
payable, net of tax |
2,254 | 2,440 | | |||||||||
Net income applicable to common stock |
$ | 31,661 | $ | 39,634 | $ | 17,197 | ||||||
Diluted net income per share |
$ | 0.97 | $ | 1.15 | $ | 0.55 | ||||||
Weighted average common shares outstanding Basic |
29,300 | 30,195 | 30,064 | |||||||||
Effect of dilutive securities: |
||||||||||||
Restricted stock and stock options |
710 | 856 | 1,038 | |||||||||
Shares issuable upon conversion of notes payable |
2,737 | 3,514 | | |||||||||
Weighted average common shares outstanding |
32,747 | 34,565 | 31,102 | |||||||||
2006 | 2005 | 2004 | ||||||||||
(in thousands) | ||||||||||||
Stock options and restricted stock |
1,551 | 570 | 155 | |||||||||
Shares issuable upon conversion of notes payable |
| | 3,514 | |||||||||
Total |
1,551 | 570 | 3,669 |
F-37
F-38
2006 | 2005 | 2004 | ||||||||||
(in thousands) | ||||||||||||
Neurosurgical and Orthopedic Implants |
$ | 166,432 | $ | 134,598 | $ | 101,791 | ||||||
Medical/Surgical Equipment |
252,865 | 143,337 | 128,034 | |||||||||
Total
revenue, net |
$ | 419,297 | $ | 277,935 | $ | 229,825 | ||||||
United States | Europe | Asia Pacific | Other Foreign | Consolidated | ||||||||||||||||
(in thousands) | ||||||||||||||||||||
Total
revenue, net: |
||||||||||||||||||||
2006 |
$ | 317,503 | $ | 77,100 | $ | 12,315 | $ | 12,379 | $ | 419,297 | ||||||||||
2005 |
207,409 | 48,645 | 11,403 | 10,478 | 277,935 | |||||||||||||||
2004 |
182,168 | 30,994 | 8,535 | 8,128 | 229,825 | |||||||||||||||
Long-lived assets: |
||||||||||||||||||||
December 31, 2006 |
33,646 | 16,081 | | | 49,727 | |||||||||||||||
December 31, 2005 |
$ | 23,938 | $ | 9,441 | $ | | $ | | $ | 33,379 |
Fourth | Third | Second | First | |||||||||||||
Quarter | Quarter | Quarter | Quarter | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
2006: |
||||||||||||||||
Total
revenue, net: |
||||||||||||||||
2006 |
$ | 125,394 | $ | 116,647 | $ | 100,121 | $ | 77,135 | ||||||||
2005 |
$ | 72,985 | $ | 69,333 | $ | 69,778 | $ | 65,839 | ||||||||
Gross margin: |
||||||||||||||||
2006 |
73,949 | 69,088 | 58,748 | 49,198 | ||||||||||||
2005 |
44,355 | 42,940 | 42,260 | 41,328 | ||||||||||||
Net income: |
||||||||||||||||
2006 |
10,131 | 2,594 | 7,977 | 8,705 | ||||||||||||
2005 |
10,615 | 10,481 | 7,655 | 8,443 | ||||||||||||
Basic net income per share: |
||||||||||||||||
2006 |
$ | 0.35 | $ | 0.09 | $ | 0.27 | $ | 0.29 | ||||||||
2005 |
$ | 0.36 | $ | 0.35 | $ | 0.25 | $ | 0.28 | ||||||||
Diluted net income per share: |
||||||||||||||||
2006 |
$ | 0.34 | $ | 0.09 | $ | 0.26 | $ | 0.28 | ||||||||
2005 |
$ | 0.33 | $ | 0.33 | $ | 0.23 | $ | 0.26 |
F-39
Fourth | Third | Second | First | |||||||||||||
Quarter | Quarter | Quarter | Quarter | |||||||||||||
(in thousands) | ||||||||||||||||
Involuntary employee termination costs |
||||||||||||||||
2006 |
$ | 693 | $ | 63 | $ | 199 | $ | 80 | ||||||||
2005 |
1,120 | 667 | 2,074 | | ||||||||||||
Facility exit costs |
||||||||||||||||
2006 |
| | | | ||||||||||||
2005 |
155 | | | |
F-40
Balance at | Charged to | Charged to | Balance at | |||||||||||||||||
Beginning of | Costs and | Other | End of | |||||||||||||||||
Description | Period | Expenses | Accounts(1) | Deductions | Period | |||||||||||||||
(in thousands) | ||||||||||||||||||||
Year ended December 31, 2006: |
||||||||||||||||||||
Allowance for doubtful
accounts and sales returns
and allowances |
$ | 3,508 | $ | 650 | $ | 350 | $ | (394 | ) | $ | 4,114 | |||||||||
Inventory reserves |
9,768 | 4,706 | 2,862 | (2,550 | ) | 14,786 | ||||||||||||||
Deferred tax asset valuation
allowance |
5,126 | | (3,494 | ) | | 1,632 | ||||||||||||||
Year ended December 31, 2005: |
||||||||||||||||||||
Allowance for doubtful
accounts and sales returns
and allowances |
$ | 2,749 | $ | 1,279 | $ | 34 | $ | (554 | ) | $ | 3,508 | |||||||||
Inventory reserves |
7,600 | 2,191 | 247 | (270 | ) | 9,768 | ||||||||||||||
Deferred tax asset valuation
allowance |
5,360 | | | (234 | ) | 5,126 | ||||||||||||||
Year ended December 31, 2004: |
||||||||||||||||||||
Allowance for doubtful
accounts and sales returns
and allowances |
$ | 2,025 | $ | 802 | $ | 249 | $ | (327 | ) | $ | 2,749 | |||||||||
Inventory reserves |
6,204 | 1,210 | 1,056 | (870 | ) | 7,600 | ||||||||||||||
Deferred tax asset valuation
allowance |
5,360 | | | | 5,360 |
(1) | All amounts shown were recorded to goodwill in connection with acquisitions except for the $3.5 million reduction in the deferred tax asset valuation allowance in 2006, which was written off against the gross deferred tax asset. |
F-41
EXHIBIT INDEX
Exhibit | ||
Number | Description | |
10.17
|
Severance Agreement between Judith OGrady and the Company dated January 1, 2007* | |
10.33
|
Compensation of Directors of the Company* | |
21
|
Subsidiaries of the Company | |
23
|
Consent of PricewaterhouseCoopers LLP | |
31.1
|
Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
31.2
|
Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
32.1
|
Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
32.2
|
Certification of Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
* | Indicates a management contract or compensatory plan or arrangement. |