08.05.13
$831 Million
KEY EXECUTIVES:
Peter J. Arduini, President, CEO and Director
Robert T. Davis Jr., Corp. VP, President, Neurosurgery
Brian Larkin, Corp. VP, President, Global Spine and Orthobiologics, and Head of Strategic Development
Robert D. Paltridge, Corp. VP, President, Extremity Reconstruction
Dan Reuvers, Corp. VP, President, Surgical Instruments
Debbie Leonetti, Corp. VP President, International
Joseph Vinhais, Corp. VP, Global Quality Assurance
John Mooradian, Corp. VP, Global Operations and Supply Chain
Judith E. O’Grady, R.N., M.S.N., Corp. VP, Global Regulatory Affairs, and Corporate Compliance Officer
NO. OF EMPLOYEES: 3,500
GLOBAL HEADQUARTERS: Plainsboro, N.J.
The folks at Integra LifeSciences are on a mission. The 24-year-old firm’s leadership has staked out a goal “to become a multi-billion-dollar global medical technology company whose products enhance millions of lives.” Both are lofty objectives. The billion-dollar barrier, if achieved, makes companies part of an exclusive club—particularly in the medical device industry, where the largest percentage of companies by far is composed of small to midsize firms. And when you break it down by sector—such as orthopedics—the number of billion-dollar behemoths shrinks substantially (as our Top 10 list illustrates). Since 2008, the company’s revenues have increased by 27 percent—buoyed by a series of strategic acquisitions in the last few years (in particular the buyout of Ascension Orthopedics at the end of 2011).
Integra manufactures devices and instruments for orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. The company’s orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. In neurosurgery, Integra makes implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care.
Part of the company’s strategy to achieve its aims is a steady stream of new product development. It did so in fiscal 2012 (ended Dec. 31) and plans to continue doing so throughout this year.
“We continue to invest in product development, with a focus on regenerative medicine and orthopedics, and expect to launch as many as 25 new products in 2013,” Peter J. Arduini, president and CEO, wrote to shareholders at the beginning of this year. “Among them is a modular shoulder system with a reverse option that will enable us to build a more comprehensive distributor network for our shoulder and elbow product lines. We expect our shoulder offering to be differentiated, and by pairing it with our regenerative medicine portfolio, we believe we can become a significant player in the $650 million shoulder market.”
Arduini also noted that his company is funding clinical evidence to enhance product launches and obtain favorable coverage decisions by insurance providers and the Centers for Medicare and Medicaid Services.
“We expect to complete the clinical trial to support the effectiveness of our dermal regenerative products in diabetic foot ulcers by the end of 2013,” he added. “If the trial and regulatory submissions are successful, we plan to launch the product for this indication in the United States, with reimbursement in 2015. We believe that clinical, regulatory and reimbursement success would dramatically increase the opportunity for our dermal regenerative medicine products.”
The company also is aggressively pursuing international markets for its new product releases, including BRIC countries China and Brazil. European product approvals also are part of the strategy.
Part of the company’s goal for 2012 was to streamline operations. Company leadership reported making “great strides” toward improving its infrastructure by streamlining manufacturing and distribution. The company established a centralized sourcing group to optimize purchases globally and by division and to improve inventory planning. The company also is working on a common quality system—a project that began in 2012.
“We expect these investments to make us a more efficient company, with improvements in both earnings and cash flow,” Arduini said.
Along those lines, the company made two key hires toward the end of FY12.
John Mooradian and Joseph Vinhais joined the company as senior vice president of global operations and supply chain, and senior vice president of global quality assurance, respectively.
Mooradian is responsible for Integra’s newly integrated global manufacturing and supply chain functions. Prior to joining Integra, he spent 24 years at Abbott Laboratories in a series of leadership roles, where he improved manufacturing processes and systems, and implemented key compliance enhancements.One of Mooradian’s key roles at Abbot was responsibility for worldwide operations at Abbott Diagnostics Division, a $4 billion business with more than 11,000 employees.
Vinhais is responsible for Integra’s global quality systems. He has more than 20 years of global experience in quality assurance, regulatory affairs, compliance and operations.He was most recently head of quality assurance, regulatory affairs and sustainability of the computed tomography and nuclear medicine business at Philips Healthcare Imaging Systems. At Philips, Vinhais developed quality and regulatory strategies for the China market, as well as other emerging markets, and realigning the quality and regulatory functions to better support the business.
The company may be planning for a significant rollout of products in 2013, but 2012 experienced its fair share of introductions as well.
In October, the company had its full U.S. market release of the Integra Complete Cervical Intervertebral Body Fusion Device (IBD), expanding the company’s spine product portfolio with the addition of a zero-profile, standalone IBD for anterior cervical decompression and fusion procedures. The system received 510(k) clearance from the U.S. Food & Drug Administration (FDA), and is designed to help provide stability for spinal fusion after a diseased cervical disc is surgically removed. Traditionally, surgeons use a supplemental fixation plate to help hold an IBD in place. However, the Integra Complete Cervical IBD features the benefit of a zero-profile, standalone design by using two screws to help secure the IBD in its functional position, eliminating the need for a supplemental fixation plate.
Also in October, the company received FDA approval for an expanded indication for use of the Integra Vu aPOD Prime IBD in anterior lumbar interbody fusion procedures. The indication includes four points of fixation, which is composed of two screws and the firm’s SpinPlate. IBDs are designed to help provide stability for spinal fusion after a diseased lumbar disc is surgically removed. They are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and allow fusion between vertebral bodies. The devices relieve pressure on the nerves and provide positive mechanical stabilization of the vertebrae. The graft window in the device is packed with bone and provides an environment in which natural bone growth can occur, which then enables fusion of the vertebral segments.
“Earlier this year the Vu aPOD Prime IBD entered its full market release with standalone indications,” said Kirt Stephenson, president of Integra’s U.S. spine business. “We’re pleased that with this additional indication, we can now provide surgeons with multiple fixation options to best meet their patients’ needs.”
Yet another October launch was Integra’s USA NXT Inferior Forward Bone Tip for the company’s CUSA NXT Ultrasonic Tissue Ablation System. The CUSA NXT system is used in neurosurgical and other surgical procedures for the controlled and selective removal of soft tissue and bone near critical structures. The newest tip in the family features a working surface that is oriented toward the inferior (bottom) surface of the tip, making it useful in situations where the surgical setting requires downward pressure for bone removal, the company claims.
In June, Integra announced a contract with Berlin, Germany-based aap Implantate AG to provide stainless-headed compression screws for mid- and hind-foot reconstruction. Headed compression screws are used in orthopedics for internal fixation of bone, typically after fractures. The new system will provide a comprehensive solution for arthrodesis and fracture management across multiple disease states, including mid-foot, ankle and hind-foot arthritis. According to the company, the new stainless steel system will feature a mid-foot set composed of 4 mm and 4.5 mm diameter screws, and a hind-foot set composed of 6.5 mm and 7.5 mm diameter screws. All screw diameters will be available in both partially threaded and fully threaded options. aap Implantate AG is a medical device company that manufactures biomaterials and implants used in orthopedic procedures.
“Headed compression screws were one of the product gaps identified by the sales force and surgeon customers, and this new product will close the gap,” said Bill Weber, vice president and general manager of Integra’s extremity reconstruction business.
Biense Visser, CEO of aap Implantate AG, said: “We have great respect for the team at Integra and are pleased to be providing them with a comprehensive Stainless Headed Compression Screw system. Integra has a strong reputation and proven track record in the industry and we believe they will be an effective partner for the distribution of this product line. The partnership also provides further validation of aap’s products and technology as we continue to expand our presence in markets outside of Europe, particularly in the United States.”
Integra’s Extremity Reconstruction business focuses on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair/protection and wound repair.
The company released its IPP-ON PIP Fusion System for the fixation of proximal interphalangeal (PIP) joint arthrodesis. It is indicated for use in the lesser toes for rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and second toe shortening. The system is a one-piece, stainless steel interphalangeal fusion device that is available in two sizes to accommodate varying patient anatomy. The device is anatomically adaptive by offering both cortical and cancellous fixation. Hammertoe is a deformity that occurs when there is a shortening of the tendon that controls toe movement. The tendon shortening causes the middle joint of the toe to be bent upward and the most distal joint downward.
In March, FDA 510(k) clearance was granted for Integra’s new line of Jarit Take-Apart Laparoscopic instruments. The new instruments allow the components to be fully disassembled, making cleaning and visual inspection easier, the company says. This product line addresses the growing concerns of both hospitals and regulatory bodies about the need for instruments that can be more easily cleaned and sterilized. Integra recently has introduced a number of products to enable hospitals to increase the certainty of using clean instruments on every patient. Adding features that increase the ease and visual verification of cleaning are expected to further limit uncertainty for operating room personnel.
The beginning of 2012 included the introduction of the Allograft Wedge System, which consists of pre-cut allograft wedges for both Evans and Cotton osteotomies and a dedicated instrumentation set that is designed to provide a method of assessing osteotomy space to aid in the selection of the appropriate implant. Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. The Allograft Wedge is designed to provide bone-grafting material for osteotomy corrections. The Allograft Wedge is processed from human cancellous bone, sterilized through the BioCleanse Tissue Sterilization Process and terminally sterilized using a validated method to achieve a sterility assurance level of 10-6. According to the company, the wedge provides a natural scaffold for bone growth, as well as biologic stability and structural support for deformity corrections.It also eliminates significant harvest site morbidity that may result from autograft removal.
Though prolific in its new product introductions, the company has had to contend with some quality issues as of late.
In November, Integra received an FDA warning letter related to quality systems issues at its manufacturing facility located in Andover, England. The letter resulted from an inspection held at that facility in June 2012. The letter did not restrict the company’s ability to manufacture or ship products or import them into the United States.It also did not require the recall of products.The Andover facility manufactures components of the CUSA ultrasonic aspirator system, and intracranial pressure monitors.
Quality woes continued into 2013. Following an FDA warning letter received in February (based on a November 2012 plant inspection), the company initiated a voluntary recall in April for some of its products manufactured during Dec. 2010-May 2011 and Nov. 2012-March 2013 at its Añasco, Puerto Rico, facility. The recall was announced as the company detected that certain lots of offerings under Duragen, NeuraWrap, NeuraGen and other families of products had slipped the quality standards due to deviations from an approved production process. The warning letter cited concerns relating to process validations, corrective and preventative actions, and document controls. The Añasco facility manufactures several of Integra’s collagen products, including Duragen Dural Graft Matrix and several OEM products sold to strategic partners through the company’s Private Label business.Sales of products manufactured or packaged in the Añasco facility constituted approximately 18 percent of Integra’s consolidated revenue during 2012, according to the company.Integra also can produce most ofthe relevant products in its facility in Plainsboro, N.J. Throughout 2012, the company worked to respond to a warning letter from the FDA in December 2011 related to quality systems and compliance issues at the Plainsboro plant. The letter resulted from an inspection held at that facility in August 2011.
The company has been working to address the issues in the letter and underwent a second FDA inspection in 2012 to evaluate progress.
KEY EXECUTIVES:
Peter J. Arduini, President, CEO and Director
Robert T. Davis Jr., Corp. VP, President, Neurosurgery
Brian Larkin, Corp. VP, President, Global Spine and Orthobiologics, and Head of Strategic Development
Robert D. Paltridge, Corp. VP, President, Extremity Reconstruction
Dan Reuvers, Corp. VP, President, Surgical Instruments
Debbie Leonetti, Corp. VP President, International
Joseph Vinhais, Corp. VP, Global Quality Assurance
John Mooradian, Corp. VP, Global Operations and Supply Chain
Judith E. O’Grady, R.N., M.S.N., Corp. VP, Global Regulatory Affairs, and Corporate Compliance Officer
NO. OF EMPLOYEES: 3,500
GLOBAL HEADQUARTERS: Plainsboro, N.J.
The folks at Integra LifeSciences are on a mission. The 24-year-old firm’s leadership has staked out a goal “to become a multi-billion-dollar global medical technology company whose products enhance millions of lives.” Both are lofty objectives. The billion-dollar barrier, if achieved, makes companies part of an exclusive club—particularly in the medical device industry, where the largest percentage of companies by far is composed of small to midsize firms. And when you break it down by sector—such as orthopedics—the number of billion-dollar behemoths shrinks substantially (as our Top 10 list illustrates). Since 2008, the company’s revenues have increased by 27 percent—buoyed by a series of strategic acquisitions in the last few years (in particular the buyout of Ascension Orthopedics at the end of 2011).
Integra manufactures devices and instruments for orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. The company’s orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. In neurosurgery, Integra makes implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care.
Part of the company’s strategy to achieve its aims is a steady stream of new product development. It did so in fiscal 2012 (ended Dec. 31) and plans to continue doing so throughout this year.
“We continue to invest in product development, with a focus on regenerative medicine and orthopedics, and expect to launch as many as 25 new products in 2013,” Peter J. Arduini, president and CEO, wrote to shareholders at the beginning of this year. “Among them is a modular shoulder system with a reverse option that will enable us to build a more comprehensive distributor network for our shoulder and elbow product lines. We expect our shoulder offering to be differentiated, and by pairing it with our regenerative medicine portfolio, we believe we can become a significant player in the $650 million shoulder market.”
Arduini also noted that his company is funding clinical evidence to enhance product launches and obtain favorable coverage decisions by insurance providers and the Centers for Medicare and Medicaid Services.
“We expect to complete the clinical trial to support the effectiveness of our dermal regenerative products in diabetic foot ulcers by the end of 2013,” he added. “If the trial and regulatory submissions are successful, we plan to launch the product for this indication in the United States, with reimbursement in 2015. We believe that clinical, regulatory and reimbursement success would dramatically increase the opportunity for our dermal regenerative medicine products.”
The company also is aggressively pursuing international markets for its new product releases, including BRIC countries China and Brazil. European product approvals also are part of the strategy.
Part of the company’s goal for 2012 was to streamline operations. Company leadership reported making “great strides” toward improving its infrastructure by streamlining manufacturing and distribution. The company established a centralized sourcing group to optimize purchases globally and by division and to improve inventory planning. The company also is working on a common quality system—a project that began in 2012.
“We expect these investments to make us a more efficient company, with improvements in both earnings and cash flow,” Arduini said.
Along those lines, the company made two key hires toward the end of FY12.
John Mooradian and Joseph Vinhais joined the company as senior vice president of global operations and supply chain, and senior vice president of global quality assurance, respectively.
Mooradian is responsible for Integra’s newly integrated global manufacturing and supply chain functions. Prior to joining Integra, he spent 24 years at Abbott Laboratories in a series of leadership roles, where he improved manufacturing processes and systems, and implemented key compliance enhancements.One of Mooradian’s key roles at Abbot was responsibility for worldwide operations at Abbott Diagnostics Division, a $4 billion business with more than 11,000 employees.
Vinhais is responsible for Integra’s global quality systems. He has more than 20 years of global experience in quality assurance, regulatory affairs, compliance and operations.He was most recently head of quality assurance, regulatory affairs and sustainability of the computed tomography and nuclear medicine business at Philips Healthcare Imaging Systems. At Philips, Vinhais developed quality and regulatory strategies for the China market, as well as other emerging markets, and realigning the quality and regulatory functions to better support the business.
The company may be planning for a significant rollout of products in 2013, but 2012 experienced its fair share of introductions as well.
In October, the company had its full U.S. market release of the Integra Complete Cervical Intervertebral Body Fusion Device (IBD), expanding the company’s spine product portfolio with the addition of a zero-profile, standalone IBD for anterior cervical decompression and fusion procedures. The system received 510(k) clearance from the U.S. Food & Drug Administration (FDA), and is designed to help provide stability for spinal fusion after a diseased cervical disc is surgically removed. Traditionally, surgeons use a supplemental fixation plate to help hold an IBD in place. However, the Integra Complete Cervical IBD features the benefit of a zero-profile, standalone design by using two screws to help secure the IBD in its functional position, eliminating the need for a supplemental fixation plate.
Also in October, the company received FDA approval for an expanded indication for use of the Integra Vu aPOD Prime IBD in anterior lumbar interbody fusion procedures. The indication includes four points of fixation, which is composed of two screws and the firm’s SpinPlate. IBDs are designed to help provide stability for spinal fusion after a diseased lumbar disc is surgically removed. They are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and allow fusion between vertebral bodies. The devices relieve pressure on the nerves and provide positive mechanical stabilization of the vertebrae. The graft window in the device is packed with bone and provides an environment in which natural bone growth can occur, which then enables fusion of the vertebral segments.
“Earlier this year the Vu aPOD Prime IBD entered its full market release with standalone indications,” said Kirt Stephenson, president of Integra’s U.S. spine business. “We’re pleased that with this additional indication, we can now provide surgeons with multiple fixation options to best meet their patients’ needs.”
Yet another October launch was Integra’s USA NXT Inferior Forward Bone Tip for the company’s CUSA NXT Ultrasonic Tissue Ablation System. The CUSA NXT system is used in neurosurgical and other surgical procedures for the controlled and selective removal of soft tissue and bone near critical structures. The newest tip in the family features a working surface that is oriented toward the inferior (bottom) surface of the tip, making it useful in situations where the surgical setting requires downward pressure for bone removal, the company claims.
In June, Integra announced a contract with Berlin, Germany-based aap Implantate AG to provide stainless-headed compression screws for mid- and hind-foot reconstruction. Headed compression screws are used in orthopedics for internal fixation of bone, typically after fractures. The new system will provide a comprehensive solution for arthrodesis and fracture management across multiple disease states, including mid-foot, ankle and hind-foot arthritis. According to the company, the new stainless steel system will feature a mid-foot set composed of 4 mm and 4.5 mm diameter screws, and a hind-foot set composed of 6.5 mm and 7.5 mm diameter screws. All screw diameters will be available in both partially threaded and fully threaded options. aap Implantate AG is a medical device company that manufactures biomaterials and implants used in orthopedic procedures.
“Headed compression screws were one of the product gaps identified by the sales force and surgeon customers, and this new product will close the gap,” said Bill Weber, vice president and general manager of Integra’s extremity reconstruction business.
Biense Visser, CEO of aap Implantate AG, said: “We have great respect for the team at Integra and are pleased to be providing them with a comprehensive Stainless Headed Compression Screw system. Integra has a strong reputation and proven track record in the industry and we believe they will be an effective partner for the distribution of this product line. The partnership also provides further validation of aap’s products and technology as we continue to expand our presence in markets outside of Europe, particularly in the United States.”
Integra’s Extremity Reconstruction business focuses on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair/protection and wound repair.
The company released its IPP-ON PIP Fusion System for the fixation of proximal interphalangeal (PIP) joint arthrodesis. It is indicated for use in the lesser toes for rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and second toe shortening. The system is a one-piece, stainless steel interphalangeal fusion device that is available in two sizes to accommodate varying patient anatomy. The device is anatomically adaptive by offering both cortical and cancellous fixation. Hammertoe is a deformity that occurs when there is a shortening of the tendon that controls toe movement. The tendon shortening causes the middle joint of the toe to be bent upward and the most distal joint downward.
In March, FDA 510(k) clearance was granted for Integra’s new line of Jarit Take-Apart Laparoscopic instruments. The new instruments allow the components to be fully disassembled, making cleaning and visual inspection easier, the company says. This product line addresses the growing concerns of both hospitals and regulatory bodies about the need for instruments that can be more easily cleaned and sterilized. Integra recently has introduced a number of products to enable hospitals to increase the certainty of using clean instruments on every patient. Adding features that increase the ease and visual verification of cleaning are expected to further limit uncertainty for operating room personnel.
The beginning of 2012 included the introduction of the Allograft Wedge System, which consists of pre-cut allograft wedges for both Evans and Cotton osteotomies and a dedicated instrumentation set that is designed to provide a method of assessing osteotomy space to aid in the selection of the appropriate implant. Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. The Allograft Wedge is designed to provide bone-grafting material for osteotomy corrections. The Allograft Wedge is processed from human cancellous bone, sterilized through the BioCleanse Tissue Sterilization Process and terminally sterilized using a validated method to achieve a sterility assurance level of 10-6. According to the company, the wedge provides a natural scaffold for bone growth, as well as biologic stability and structural support for deformity corrections.It also eliminates significant harvest site morbidity that may result from autograft removal.
Though prolific in its new product introductions, the company has had to contend with some quality issues as of late.
In November, Integra received an FDA warning letter related to quality systems issues at its manufacturing facility located in Andover, England. The letter resulted from an inspection held at that facility in June 2012. The letter did not restrict the company’s ability to manufacture or ship products or import them into the United States.It also did not require the recall of products.The Andover facility manufactures components of the CUSA ultrasonic aspirator system, and intracranial pressure monitors.
Quality woes continued into 2013. Following an FDA warning letter received in February (based on a November 2012 plant inspection), the company initiated a voluntary recall in April for some of its products manufactured during Dec. 2010-May 2011 and Nov. 2012-March 2013 at its Añasco, Puerto Rico, facility. The recall was announced as the company detected that certain lots of offerings under Duragen, NeuraWrap, NeuraGen and other families of products had slipped the quality standards due to deviations from an approved production process. The warning letter cited concerns relating to process validations, corrective and preventative actions, and document controls. The Añasco facility manufactures several of Integra’s collagen products, including Duragen Dural Graft Matrix and several OEM products sold to strategic partners through the company’s Private Label business.Sales of products manufactured or packaged in the Añasco facility constituted approximately 18 percent of Integra’s consolidated revenue during 2012, according to the company.Integra also can produce most ofthe relevant products in its facility in Plainsboro, N.J. Throughout 2012, the company worked to respond to a warning letter from the FDA in December 2011 related to quality systems and compliance issues at the Plainsboro plant. The letter resulted from an inspection held at that facility in August 2011.
The company has been working to address the issues in the letter and underwent a second FDA inspection in 2012 to evaluate progress.
By the Numbers For FY12, revenue increased by $50.8 million or 7 percent, to $830.9 million from $780.1 million in 2011. Domestic revenue increased by 9 percent to $642.8 million and was 77 percent of total revenue for the year. International revenue was flat at $188.1 million compared with 2011. Foreign exchange fluctuations—primarily from a weaker euro throughout the year compared to the U.S. dollar—accounted for a $6.8 million decrease in revenue. On a constant currency basis, overall revenue increased 7 percent. U.S. Neurosurgery revenue was $171.3 million, a 3 percent rise. The increase resulted from stronger sales of duraplasty products and cranial stabilization products, as well as strength in the critical care sector, according to the company. U.S. Instruments revenue was $162.3 million, an increase of 4 percent. U.S. Extremities revenue rose 25 percent to $122.8 million, primarily from significant increases in sales of dermal and wound care products. Sales of metal implants also increased more than 30 percent, especially products for the foot and ankle and hand and wrist, in part because of the acquisition of Ascension Orthopedics in September 2011. U.S. Spine and “other” revenue, which includes spine hardware, orthobiologics and private-label products, were $190.5 million, an increase of 9 percent. The company reported continued double-digit growth in orthobiologics sales as well as with spine hardware products, which also had double-digit growth. International revenue was $183.9 million, down 1 percent. Sales in Europe declined 6 percent, but on a constant currency basis sales would have been in line with prior year. The company experienced decreases in capital spending as European hospitals continued to control costs and reported that Greece, Ireland, Italy, Portugal and Spain “remained challenging” throughout 2012. Outside of Europe, the company posted a 5 percent sales increase. The neurosurgery and extremities product categories posted the strongest performances from a product standpoint, with China and Brazil showing strong growth. Net income for the year was $41.2 million, up from $27.9 million in 2011, or $1.44 per share vs. 95 cents. So far for 2013, the company is off to a sluggish start. For the first quarter (ended March 29), Integra reported adjusted earnings per share of 39 cents in the first quarter of 2013, declining 45.1 percent from 2012. Total revenues for the first quarter were $196.7 million, up only half a million dollars compared with 2012. The company reduced its revenue in the quarter by $2.9 million because of product returned in the voluntary recall announced in April, and estimates that it was unable to satisfy customer demand for an additional $6 million to $7 million. “The recent voluntary product recall and related product shortages created a near-term challenge, driving our outlook for 2013 lower,” Arduini said. |