08.05.13
$2.8 Billion
KEY EXECUTIVES:
Jeffrey R. Binder, President & CEO
Robin T. Barney, Sr. VP, Worldwide Operations
Sujata T. Dayal, Corporate Vice President & Chief Compliance Officer
Bart Doedens, President, Biomet 3i
Daniel P. Florin, Sr. VP & Chief Financial Officer
Daniel P. Hann, Sr. VP, Business Development
Adam Johnson, Sr. VP & President, Spine and Bone Healing Technologies
Jon C. Serbousek, President, Biologics
Bradley J. Tandy, Sr. VP, General Counsel & Secretary
Renaat Vermeulen, Sr. VP, Biomet; President of Europe, Middle East and Africa
NO. OF EMPLOYEES: 3,403
GLOBAL HEADQUARTERS: Warsaw, Ind.
Biomet ended 2012 with a major acquisition deal under its belt. Just at the close of fiscal year 2012 (ended May 31), the company announced initial closing on the purchase of DePuy Trauma, gaining operations in the United States, United Kingdom, Australia, New Zealand, Japan, and a manufacturing location in Switzerland—which it closed a year later in July 2013. Medical device giant Johnson and Johnson (JNJ), which owns DePuy Orthopaedics, divested of DePuy’s trauma business in part to convince European antitrust authorities to let JNJ buy Swiss company Synthes without gaining too large of a market share on the continent. Biomet’s deal took a year to close, and was finalized in July of this year for $280 million in cash.
To bookend the year’s happy ending, FY12 began with positive clinical trial results from Biomet’s Phase I safety trial for autologous concentrated bone marrow aspirate (BMA) therapy in the treatment of critical limb ischemia (CLI). The trial, performed under a U.S. Food and Drug Administration (FDA)-approved investigational new drug application, evaluated the safety of autologous concentrated BMA therapy in 29 “no-option” CLI subjects who were at risk for major amputation due to severe peripheral arterial disease. The investigational treatment used the company’s Marrowstim device for point-of-care concentration of the autologous BMA. There were no reports of procedure-related deaths; two reports of procedure-related serious adverse events; one year amputation-free survival rate of 86.3 percent; improvement in rest pain, quality of life, and perfusion measures at 12-weeks post-treatment; and overall average Marrowstim procedure time (i.e., aspiration, concentration, delivery) of less than two hours.
“The results of this study are a crucial step in potentially providing alternative treatment for those patients who have no options other than amputation,” said lead investigator Michael P. Murphy, M.D., clinical director of the Vascular and Cardiac Center for Adult Stem Cell Therapy and assistant professor of vascular surgery at Indiana University School of Medicine in Indianapolis, Ind.
Biomet President and CEO Jeffrey R. Binder called the program “an important element of Biomet’s emerging biologics platform.” The subsequent trial phases are still ongoing.
Biomet’s sports, extremities and trauma business did well in FY12, bringing in net sales of $354.4 million, growing 13 percent over FY11. Sports medicine and extremities held the segment up with 18 percent growth each, while trauma saw a 2 percent decrease in net sales revenue. The addition of DePuy Trauma had no effect on the segment’s sales—however, Binder said last year that “trauma is one of the fastest-growing market segments in orthopedics and at the core of orthopedic care,” suggesting that Biomet has plans to grow its trauma business significantly.
“This transaction will provide Biomet with a much stronger presence in the global trauma market and greatly expands our sports, extremities and trauma business, which is a meaningful growth driver for Biomet,” said Binder. “The DePuy Trauma team has done a great job of building a successful business.”
While sports, extremities and trauma showed the most growth, Biomet’s most lucrative business segment was large joint reconstructive. Net sales for FY12 were $1.7 billion, up 4 percent from FY11. In the third quarter of FY12, the company gained significant FDA 510(k) clearances in the segment for its E1 humeral bearing for use with the Comprehensive reverse shoulder system and the Comprehensive segmental revision system (SRS). Reverse shoulder replacements usually are performed on patients with large rotator cuff tears who have developed a complex type of shoulder arthritis called cuff tear arthropathy. The E1 humeral bearing features “antioxidant-infused technology,” and is a vitamin E-infused advanced bearing option for reverse shoulder applications. Biomet first applied E1 technology to its hip and knee products, which was clinically successful. Vitamin E in polymers help the material retain improved mechanical and wear properties throughout the product.
The advantage of applying advanced bearing surfaces to the shoulder, as Biomet did, is increased wear characteristics. The second cleared product, the Comprehensive SRS, is a humeral replacement system designed to address significant bone loss, both proximally and distally. The system offers oncologic options and soft tissue attachments.
Also in FY12, Biomet released the Signature personalized patient care system for use with its Oxford partial knee system. The Signature system, previously cleared by the FDA, is designed to enabled preoperative planning and precise placement of implants via its positioning guides. It can be used with various surgeries, but this launch was significant last year for Biomet’s large joint reconstruction segment. Later in the year, in September, Biomet also announced a lifetime warranty on its Oxford knee replacements. The company will cover the cost of a Biomet replacement implant for U.S. patients who received the Oxford partial knee implanted utilizing Signature technology and need revision surgery for any reason, subject to the terms and conditions of the written warranty.
Larry Likover, M.D., an orthopedic surgeon based in Houston, Texas, who has implanted more than 800 Oxford knees, endorsed the product, claiming on his website that “No other partial knee replacement has the proven success rate and longevity of Oxford.”
Spine and bone healing suffered a 4 percent decrease in net revenue, bringing in $314 million in net sales.
In the works for the spine and bone healing segment is a new product called Sternalock Blu closure system designed to close sternal bone separations and aid in bone healing. Biomet began a clinical trial in February 2013, which will compare Sternalock with conventional wire cerclage, and evaluate analgesic usage, patient function and quality of life, and complications after surgery.
Biomet saw growth across all overseas segments in FY12: Europe brought in net sales revenue of $702.7 million, a 1 percent growth over the previous year; international net sales garnered $422.1 million, a hefty 13 percent growth over FY11; and domestic sales grew 3 percent to $1.7 billion.
The company’s recent decision to shut down its newly acquired Switzerland manufacturing location—which belonged to DePuy Trauma—was motivated by a sagging economy and declining global prices for medical devices, a company spokesperson said. Operations at the closed plant will be distributed between Biomet’s other facilities worldwide.
In the last quarter of FY12, in March, half a decade of uncomfortable negotiations came to close when Biomet reached a settlement agreement with the U.S. Department of Justice (DOJ) and U.S. Securities and Exchange Commission (SEC). Biomet, along with the likes of Stryker Corp., Zimmer Holdings Inc., Smith & Nephew plc and Medtronic Inc., came under investigation in 2007 for bribery of doctors who work in government-operated hospitals overseas to use their products. Last year, the company entered into a deferred prosecution agreement (DPA), agreed to pay a criminal fine of $17.3 million in its settlement with the DOJ, as well as a $5.5 million in disgorgement of profits and pre-judgment interest to the SEC.
The federal government agreed not to prosecute Biomet for bribery provided that the company satisfies its obligations under the agreement over a period of three years from the settlement. The DPA called for the appointment of an independent external compliance monitor to review the company’s compliance with the DPA, particularly in relation to the company’s international sales practices, for at least the first 18 months of the three-year term of the DPA. “Moving forward, we intend to continue to adhere to our enhanced global compliance procedures, and to promote the company’s commitment to the highest ethical standards in all the markets that we serve,” Binder said at the time of the settlement.
The company ended FY12 with a net sales increase of 3.6 percent to $2.83 billion, and a gross profit bump of 2.6 percent to $1.94 billion. Bottom line, however, was a net loss of $457.8 million—though almost a 50 percent improvement from FY11 which ended at a loss of $849.8 million.
KEY EXECUTIVES:
Jeffrey R. Binder, President & CEO
Robin T. Barney, Sr. VP, Worldwide Operations
Sujata T. Dayal, Corporate Vice President & Chief Compliance Officer
Bart Doedens, President, Biomet 3i
Daniel P. Florin, Sr. VP & Chief Financial Officer
Daniel P. Hann, Sr. VP, Business Development
Adam Johnson, Sr. VP & President, Spine and Bone Healing Technologies
Jon C. Serbousek, President, Biologics
Bradley J. Tandy, Sr. VP, General Counsel & Secretary
Renaat Vermeulen, Sr. VP, Biomet; President of Europe, Middle East and Africa
NO. OF EMPLOYEES: 3,403
GLOBAL HEADQUARTERS: Warsaw, Ind.
Biomet ended 2012 with a major acquisition deal under its belt. Just at the close of fiscal year 2012 (ended May 31), the company announced initial closing on the purchase of DePuy Trauma, gaining operations in the United States, United Kingdom, Australia, New Zealand, Japan, and a manufacturing location in Switzerland—which it closed a year later in July 2013. Medical device giant Johnson and Johnson (JNJ), which owns DePuy Orthopaedics, divested of DePuy’s trauma business in part to convince European antitrust authorities to let JNJ buy Swiss company Synthes without gaining too large of a market share on the continent. Biomet’s deal took a year to close, and was finalized in July of this year for $280 million in cash.
To bookend the year’s happy ending, FY12 began with positive clinical trial results from Biomet’s Phase I safety trial for autologous concentrated bone marrow aspirate (BMA) therapy in the treatment of critical limb ischemia (CLI). The trial, performed under a U.S. Food and Drug Administration (FDA)-approved investigational new drug application, evaluated the safety of autologous concentrated BMA therapy in 29 “no-option” CLI subjects who were at risk for major amputation due to severe peripheral arterial disease. The investigational treatment used the company’s Marrowstim device for point-of-care concentration of the autologous BMA. There were no reports of procedure-related deaths; two reports of procedure-related serious adverse events; one year amputation-free survival rate of 86.3 percent; improvement in rest pain, quality of life, and perfusion measures at 12-weeks post-treatment; and overall average Marrowstim procedure time (i.e., aspiration, concentration, delivery) of less than two hours.
“The results of this study are a crucial step in potentially providing alternative treatment for those patients who have no options other than amputation,” said lead investigator Michael P. Murphy, M.D., clinical director of the Vascular and Cardiac Center for Adult Stem Cell Therapy and assistant professor of vascular surgery at Indiana University School of Medicine in Indianapolis, Ind.
Biomet President and CEO Jeffrey R. Binder called the program “an important element of Biomet’s emerging biologics platform.” The subsequent trial phases are still ongoing.
Biomet’s sports, extremities and trauma business did well in FY12, bringing in net sales of $354.4 million, growing 13 percent over FY11. Sports medicine and extremities held the segment up with 18 percent growth each, while trauma saw a 2 percent decrease in net sales revenue. The addition of DePuy Trauma had no effect on the segment’s sales—however, Binder said last year that “trauma is one of the fastest-growing market segments in orthopedics and at the core of orthopedic care,” suggesting that Biomet has plans to grow its trauma business significantly.
“This transaction will provide Biomet with a much stronger presence in the global trauma market and greatly expands our sports, extremities and trauma business, which is a meaningful growth driver for Biomet,” said Binder. “The DePuy Trauma team has done a great job of building a successful business.”
While sports, extremities and trauma showed the most growth, Biomet’s most lucrative business segment was large joint reconstructive. Net sales for FY12 were $1.7 billion, up 4 percent from FY11. In the third quarter of FY12, the company gained significant FDA 510(k) clearances in the segment for its E1 humeral bearing for use with the Comprehensive reverse shoulder system and the Comprehensive segmental revision system (SRS). Reverse shoulder replacements usually are performed on patients with large rotator cuff tears who have developed a complex type of shoulder arthritis called cuff tear arthropathy. The E1 humeral bearing features “antioxidant-infused technology,” and is a vitamin E-infused advanced bearing option for reverse shoulder applications. Biomet first applied E1 technology to its hip and knee products, which was clinically successful. Vitamin E in polymers help the material retain improved mechanical and wear properties throughout the product.
The advantage of applying advanced bearing surfaces to the shoulder, as Biomet did, is increased wear characteristics. The second cleared product, the Comprehensive SRS, is a humeral replacement system designed to address significant bone loss, both proximally and distally. The system offers oncologic options and soft tissue attachments.
Also in FY12, Biomet released the Signature personalized patient care system for use with its Oxford partial knee system. The Signature system, previously cleared by the FDA, is designed to enabled preoperative planning and precise placement of implants via its positioning guides. It can be used with various surgeries, but this launch was significant last year for Biomet’s large joint reconstruction segment. Later in the year, in September, Biomet also announced a lifetime warranty on its Oxford knee replacements. The company will cover the cost of a Biomet replacement implant for U.S. patients who received the Oxford partial knee implanted utilizing Signature technology and need revision surgery for any reason, subject to the terms and conditions of the written warranty.
Larry Likover, M.D., an orthopedic surgeon based in Houston, Texas, who has implanted more than 800 Oxford knees, endorsed the product, claiming on his website that “No other partial knee replacement has the proven success rate and longevity of Oxford.”
Spine and bone healing suffered a 4 percent decrease in net revenue, bringing in $314 million in net sales.
In the works for the spine and bone healing segment is a new product called Sternalock Blu closure system designed to close sternal bone separations and aid in bone healing. Biomet began a clinical trial in February 2013, which will compare Sternalock with conventional wire cerclage, and evaluate analgesic usage, patient function and quality of life, and complications after surgery.
Biomet saw growth across all overseas segments in FY12: Europe brought in net sales revenue of $702.7 million, a 1 percent growth over the previous year; international net sales garnered $422.1 million, a hefty 13 percent growth over FY11; and domestic sales grew 3 percent to $1.7 billion.
The company’s recent decision to shut down its newly acquired Switzerland manufacturing location—which belonged to DePuy Trauma—was motivated by a sagging economy and declining global prices for medical devices, a company spokesperson said. Operations at the closed plant will be distributed between Biomet’s other facilities worldwide.
In the last quarter of FY12, in March, half a decade of uncomfortable negotiations came to close when Biomet reached a settlement agreement with the U.S. Department of Justice (DOJ) and U.S. Securities and Exchange Commission (SEC). Biomet, along with the likes of Stryker Corp., Zimmer Holdings Inc., Smith & Nephew plc and Medtronic Inc., came under investigation in 2007 for bribery of doctors who work in government-operated hospitals overseas to use their products. Last year, the company entered into a deferred prosecution agreement (DPA), agreed to pay a criminal fine of $17.3 million in its settlement with the DOJ, as well as a $5.5 million in disgorgement of profits and pre-judgment interest to the SEC.
The federal government agreed not to prosecute Biomet for bribery provided that the company satisfies its obligations under the agreement over a period of three years from the settlement. The DPA called for the appointment of an independent external compliance monitor to review the company’s compliance with the DPA, particularly in relation to the company’s international sales practices, for at least the first 18 months of the three-year term of the DPA. “Moving forward, we intend to continue to adhere to our enhanced global compliance procedures, and to promote the company’s commitment to the highest ethical standards in all the markets that we serve,” Binder said at the time of the settlement.
The company ended FY12 with a net sales increase of 3.6 percent to $2.83 billion, and a gross profit bump of 2.6 percent to $1.94 billion. Bottom line, however, was a net loss of $457.8 million—though almost a 50 percent improvement from FY11 which ended at a loss of $849.8 million.