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| WMGI > SEC Filings for WMGI > Form 10-K on 22-Feb-2013 | All Recent SEC Filings |
22-Feb-2013
Annual Report
Executive Overview
Company Description. We are a global orthopaedic medical device company
operating as two reportable business segments based on the two primary markets
that we operate within: Extremities and OrthoRecon. We specialize in the design,
manufacture and marketing of devices and biologic products for extremity, hip,
and knee repair and reconstruction.
Our Extremities segment includes products that are used primarily in foot and
ankle repair, upper extremity products, and biologics products, which are used
to replace damaged or diseased bone, to stimulate bone growth and to provide
other biological solutions for surgeons and their patients. Extremity hardware
includes implants and other devices to replace or reconstruct injured or
diseased joints and bones of the foot, ankle, hand, wrist, elbow and shoulder,
which we generally refer to as either foot and ankle or upper extremity
products. We are a leading provider of surgical solutions for the foot and ankle
market. Our extensive foot and ankle product portfolio, our approximately 200
specialized foot and ankle sales representatives, and our increasing level of
training of foot and ankle surgeons has resulted in our being a recognized
leader in the foot and ankle market. Biologics are used to repair or replace
damaged or diseased bone, to stimulate bone growth and to provide other
biological solutions for surgeons and their patients.
Our OrthoRecon segment includes products that are used primarily to replace or
repair knee, hip and bones that have deteriorated or have been damaged through
disease or injury. Reconstructive devices are used to replace or repair knee,
hip and other joints and bones that have deteriorated or been damaged through
disease or injury.
We have been in business for over 60 years and have built a well-known and
respected brand name.
Our corporate headquarters and U.S. operations are located in Arlington,
Tennessee, where we conduct research and development, sales and marketing
administration, manufacturing, warehousing and administrative activities. Our
U.S. sales accounted for 57% of total revenue in 2012. Outside the U.S., we have
distribution and administrative facilities in Amsterdam, the Netherlands, and
sales and distribution offices in Canada, Japan and throughout Europe. As of
December 31, 2012, through a combination of our direct sales offices and
approximately 80 stocking distribution partners, we have approximately 750
international sales representatives that sell our products in approximately 60
countries.
Principal Products. We primarily sell devices and biologic products for
extremity, hip, and knee repair and reconstruction. We specialize in extremity
and biologic products used by extremity focused surgeon specialists for the
reconstruction, trauma and arthroscopy markets. Our biologics sales encompass a
broad portfolio of products designed to stimulate and augment the natural
regenerative capabilities of the human body. We also sell orthopaedic products
not considered to be part of our knee, hip, extremity or biologic product lines.
Our extremities product line includes products for both the foot and ankle and
the upper extremity markets. Our principal foot and ankle portfolio includes the
INBONE™ total ankle system, the CLAW® II Polyaxial Compression Plating System,
the ORTHOLOC™ 3Di Reconstruction Plating System, the PRO-TOE® VO Hammertoe
System, the DARCO® family of locked plating systems, the VALOR™ ankle fusion
nail system, and the Swanson line of toe joint replacement products. Our upper
extremity portfolio includes the MICRONAIL® intramedullary wrist fracture repair
system, the EVOLVE® radial head prosthesis for elbow fractures, the RAYHACK®
osteotomy system, and the EVOLVE® Elbow Plating System.
Our biologic products focus on biological musculoskeletal repair and include
synthetic and human tissue-based materials. Our principal biologic products
include the GRAFTJACKET® line of soft tissue repair and containment membranes,
the ALLOMATRIX® line of injectable tissue-based bone graft substitutes, the
PRO-DENSE® injectable regenerative graft, the OSTEOSET® synthetic bone graft
substitute, and the PRO-STIM™ injectable inductive graft.
Our knee reconstruction products position us well in the areas of total knee
reconstruction, revision replacement implants and limb preservation products.
Our principal knee products are the EVOLUTION™ Medial-Pivot Knee System, and the
ADVANCE® knee system.
Our hip joint reconstruction product portfolio provides offerings in the areas
of bone-conserving implants, total hip reconstruction, revision replacement
implants and limb preservation. Our hip reconstruction products include the
PROFEMUR® family of hip stems, and the DYNASTY™ acetabular cup system.
Significant Business Developments. Net sales declined 6% in 2012, totaling
$483.8 million, compared to $512.9 million in 2011, as growth in our foot and
ankle business was more than offset by declines in our other product lines.
Our 2012 domestic sales declined 7%, as a 12% increase in our U.S. foot and
ankle sales was more than offset by a 15% decline in our OrthoRecon segment,
which was negatively affected by customer losses associated with distributor
transitions and challenges associated with implementing enhancements to our
compliance processes. In addition, our U.S. biologics sales decreased 16% due in
part to the impact of our 2011 agreement with Kinetic Concepts, Inc. (KCI) where
we licensed our GRAFTJACKET® brand to KCI for exclusive use in wound markets,
which precluded us from marketing our GRAFTJACKET® products in the wound care
field beginning July 1, 2011.
Our international sales decreased by 4% during 2012 as compared to 2011 driven
primarily by pricing decreases in Japan and unfavorable foreign currency
exchange rates.
In 2012, net income totaled $5.3 million, compared to a net loss of $5.1
million in 2011. Items favorably impacting net income in 2012 as compared to
2011 included:
• a $15.3 million ($9.7 million net of taxes) decrease in restructuring charges;
• a $15.0 million ($9.6 million net of taxes) gain on the sale of certain internally-developed intellectual property recognized during 2012;
• a $13.2 million ($8.5 million net of taxes) provision for product liability associated with modular necks recognized during 2011; and
• a $6.3 million ($3.6 million net of taxes) decrease in expenses associated with the deferred prosecution agreement and U.S. governmental inquiries.
Items unfavorably impacting net income in 2012 included:
• charges of $4.1 million ($2.6 million net of taxes) associated with
transitioning a major portion of our U.S. independent distributor foot and
ankle territories to direct employee sales representation;
• charges of $8.4 million ($5.2 million net of taxes) associated with the issuance of our 2017 Convertible Senior Notes and termination of our amended and restated revolving credit agreement (Senior Credit Facility); and
• decreased profitability in our OrthoRecon segment, primarily driven by sales declines.
During 2012, we converted a major portion of our U.S. foot and ankle distributor
territories to direct sales representation. We believe this increase in U.S.
direct foot and ankle sales representation, coupled with our large and growing
product portfolio and increased investment in medical education, will enable us
to continue improving our growth rates in foot and ankle. In conjunction with
our U.S. foot and ankle sales force conversions, we entered into agreements with
certain distributors, which included non-compete clauses. As a result, we
recorded $9.3 million of non-compete intangible assets and recognized $3.0
million of associated amortization expenses. Additionally we recorded $1.0
million of expenses related to this conversion during 2012. We will recognize
amortization expense related to these conversions over the next two years, which
will have a negative impact on our profitability.
In August 2012, we issued $300 million of 2.000% Convertible Senior Notes (2017
Notes), which generated net proceeds of $290.8 million. We used $130 million of
the proceeds from the issuance of the 2017 Notes to repay the $150 million under
a delayed draw term loan (Term Loan) under our Senior Credit Facility and to
terminate the Senior Credit Facility. In connection with the offering of the
2017 Notes, we entered into convertible note hedging transactions with three
counterparties (the Option Counterparties). We also entered into warrant
transactions in which we sold warrants for an aggregate of 11.8 million shares
of our common stock to the Option Counterparties. We paid the Option
Counterparties approximately $56.2 million for the convertible note hedge and
received approximately $34.6 million from the Option Counterparties for the
warrants. See Notes 8 and 10 for additional information regarding these
transactions.
We used $25.3 million of the proceeds from the issuance of the 2017 Notes to
repurchase a portion of outstanding principal of our 2014 Convertible Senior
Notes (2014 Notes). As of December 31, 2012, $3.8 million aggregate principal
amount of the 2014 Notes remain outstanding.
Our Deferred Prosecution Agreement (DPA) expired on September 29, 2012. On
October 5, 2012, we received notice that the United States Attorney's Office
(USAO) dismissed the pending criminal complaint filed in September 2010 against
us. Upon the expiration of the DPA, our amended Corporate Integrity Agreement
(CIA) became effective. See additional discussion of our DPA and CIA in
Significant Industry Factors.
In November 2012, we announced that Pascal E.R. Girin was named Executive Vice
President and Chief Operating Officer. Mr. Girin has global responsibility for
our Extremities and OrthoRecon businesses, and Clinical, Regulatory and Quality.
In addition, we announced a new divisional structure, whereby we created an
Extremities division and an OrthoRecon division. Eric Stookey, formerly our
Chief Commercial Officer, was promoted to President of our Extremities division
and Ted Davis, formerly our Senior Vice President of Corporate Development, was
promoted to President of our OrthoRecon division.
In November 2012, we announced that we entered into a definitive agreement with
BioMimetic for a business combination of Wright and BioMimetic. BioMimetic is
focused on developing regenerative medicine products to promote the healing of
musculoskeletal injuries and diseases with a novel protein therapeutic product,
Augment® Bone Graft, under late stage FDA review as a replacement for autologous
bone graft in foot and ankle fusions. The transaction will combine BioMimetic's
breakthrough biologics platform and pipeline with our established sales force
and product portfolio, to further accelerate growth in our Extremities business.
Under the terms of the agreement, the transaction has a total potential value
for BioMimetic shareholders of $380 million, based on our closing stock price on
November 16, 2012, including an upfront payment of $1.50 in cash and 0.2482
shares of Wright common stock per share of BioMimetic stock, valued at
approximately $190 million. Each BioMimetic share will also receive one tradable
Contingent Value Right (CVR), which entitles its holder to receive additional
cash payments of up to $6.50 per share, which are payable upon receipt of FDA
approval of Augment® Bone Graft and upon achieving certain revenue milestones.
We expect the transaction to close in the first quarter of 2013, subject to
customary closing conditions, including BioMimetic shareholder approval. A
BioMimetic shareholder vote is scheduled for February 26, 2013.
Opportunities and Challenges. We believe that we have an opportunity to
transform our business to increase our foot and ankle revenue growth rates,
stabilize our OrthoRecon business, and increase our cash generation through
significant reduction of our inventories. We made changes in 2012 to realize
these opportunities, including aggressively converting a portion of our U.S.
independent distributor foot and ankle territories to direct sales
representation, substantially increasing our investment in foot and ankle
medical education to drive market adoption of new products and technologies, and
implementing steps to significantly reduce inventories over the next several
years. As a result, our foot and ankle business grew 14% compared to 2011 and we
generated $49.5 million of free cash flow during 2012. As we move into 2013, we
expect to build on this momentum with new initiatives to increase sales
productivity by reducing non-revenue generating activities, improve gross
margins and stabilize our OrthoRecon business.
Our U.S. OrthoRecon business will continue to be unfavorably affected by the
full-year impact of customer losses and revenue dis-synergies associated with
our U.S. foot and ankle sales force conversion in 2012. Our international
OrthoRecon businesses will be negatively impacted by the full-year impact of
Japan pricing declines.
Beginning in 2013, we will be subject to a 2.3% excise tax on U.S. sales of
medical devices, as prescribed in the Affordable Care Act. This tax will have a
negative impact on our profitability.
Significant Industry Factors. Our industry is affected by numerous competitive,
regulatory, and other significant factors. The growth of our business relies on
our ability to continue to develop new products and innovative technologies,
obtain regulatory clearance and compliance for our products, protect the
proprietary technology of our products and our manufacturing processes,
manufacture our products cost-effectively, respond to competitive pressures
specific to each of our geographic markets, including our ability to enforce
non-compete agreements, and successfully market and distribute our products in a
profitable manner. We, and the entire industry, are subject to extensive
governmental regulation, primarily by the FDA. Failure to comply with regulatory
requirements could have a material adverse effect on our business. Additionally,
our industry is highly competitive and has recently experienced increased
pricing pressures, specifically in the areas of reconstructive joint devices.
In December 2007, we received a subpoena from the United States Department of
Justice (DOJ) through the United States Attorney's Office for the District of
New Jersey (USAO) requesting documents for the period January 1998 through the
present related to any consulting and professional service agreements with
orthopaedic surgeons in connection with hip or knee joint replacement procedures
or products. This subpoena was served shortly after several of our knee and hip
competitors agreed with the DOJ to resolutions of similar investigations.
On September 29, 2010, WMT, entered into a 12-month Deferred Prosecution
Agreement (DPA) with the USAO and a Civil Settlement Agreement (CSA) with the
United States. Under the DPA, the USAO filed a criminal complaint in the United
States District Court for the District of New Jersey charging WMT with
conspiracy to commit violations of the Anti-Kickback Statute (42 U.S.C. §
1320a-7b) during the years 2002 through 2007. The court deferred prosecution of
the criminal complaint during the term of the DPA and the USAO agreed that if
WMT complied with the DPA's provisions, the USAO would seek dismissal of the
criminal complaint.
Pursuant to the CSA, WMT settled civil and administrative claims relating to the
matter for a payment of $7.9 million without any admission by WMT. In
conjunction with the CSA, WMT also entered into a five year Corporate Integrity
Agreement (CIA) with the Office of the Inspector General of the United States
Department of Health and Human Services (OIG-HHS). Pursuant to the DPA, an
independent monitor reviewed and evaluated WMT's compliance with its obligations
under the DPA. The DPA and the CIA were filed as Exhibits 10.3 and 10.2,
respectively, to our current report on Form 8-K filed on September 30, 2010. The
DPA was also posted to our website. Each of the DPA and the CIA could be
modified by mutual consent of the parties thereto.
On September 15, 2011, WMT reached an agreement with the USAO and the OIG-HHS
under which WMT voluntarily agreed to extend the term of its DPA for 12 months,
to September 29, 2012. On September 15, 2011, WMT also agreed with the OIG-HHS
to an amendment to the CIA under which certain of WMT's substantive obligations
under the CIA would begin on September 29, 2012, when the amended DPA monitoring
period expired. The term of the CIA has not changed, and will expire as
previously provided on September 29, 2015.
On October 4, 2012, the USAO issued a press release announcing that the amended
DPA had expired on September 29, 2012, that it had moved to dismiss the criminal
complaint against WMT because WMT had fully complied with the terms of the DPA,
and that the Court had ordered dismissal of the complaint on October 4, 2012.
The DPA imposed, and the CIA continues to impose, certain obligations on WMT to
maintain compliance with U.S. healthcare laws, regulations and other
requirements. Our failure to do so could expose us to significant liability
including, but not limited to, exclusion from federal healthcare program
participation, including Medicaid and Medicare, which would have a material
adverse effect on our financial condition, results of operations and cash flows,
potential prosecution, civil and criminal fines or penalties, and additional
litigation cost and expense.
In addition to the USAO and OIG-HHS, other governmental agencies, including
state authorities, could conduct investigations or institute proceedings that
are not precluded by the terms of the settlements reflected in the DPA and the
CIA. In addition, the settlement with the USAO and OIG-HHS could increase our
exposure to lawsuits by potential whistleblowers, including under the federal
false claims acts, based on new theories or allegations arising from the
allegations made by the USAO. The costs of defending or resolving any such
investigations or proceedings could have a material adverse effect on our
financial condition, results of operations and cash flows.
The successful implementation of our enhanced compliance program requires the
full and sustained cooperation of our employees, distributors, and sales agents
as well as the healthcare professionals with whom they interact. These efforts
may require increased expenses and additional investments. We may also encounter
inefficiencies in the implementation of our new compliance enhancements,
including delays in medical education, research and development projects, and
clinical studies, which may unfavorably impact our business and our
relationships with customers.
A detailed discussion of these and other factors is provided in "Risk Factors."
We market metal-on-metal hip (MoM) arthroplasty systems. On June 27 and June
28, 2012, FDA's Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee met and discussed the safety and effectiveness of MoM
hip arthroplasty systems. FDA sought expert scientific and clinical opinion on
the risks and benefits of MoM hip arthroplasty systems from the Committee and
the public. In January 2013, the FDA proposed a new regulation requiring that
all MoM hip implants undergo the full PMA process, with supportive clinical
data. This regulation applies to currently marketed devices, as well as those
entering the market for the first time. FDA has not provided a date for final
implementation and enforcement of this new requirement.
Results of Operations
Comparison of the year ended December 31, 2012 to the year ended December 31,
2011
The following table sets forth, for the periods indicated, our results of
operations expressed as dollar amounts (in thousands) and as percentages of net
sales:
Year Ended December 31,
2012 2011
Amount % of Sales Amount % of Sales
Net sales $ 483,776 100.0 % $ 512,947 100.0 %
Cost of sales1 149,978 31.0 % 156,906 30.6 %
Cost of sales - restructuring 435 0.1 % 2,471 0.5 %
Gross profit 333,363 68.9 % 353,570 68.9 %
Operating expenses:
Selling, general and administrative1 290,261 60.0 % 301,588 58.8 %
Research and development1 27,033 5.6 % 30,114 5.9 %
Amortization of intangible assets 5,772 1.2 % 2,870 0.6 %
Gain on sale of intellectual property (15,000 ) (3.1 )% - - %
Restructuring charges 1,153 0.2 % 14,405 2.8 %
Total operating expenses 309,219 63.9 % 348,977 68.0 %
Operating income 24,144 5.0 % 4,593 0.9 %
Interest expense, net 10,188 2.1 % 6,529 1.3 %
Other expense, net 5,395 1.1 % 4,719 0.9 %
Income (loss) before income taxes 8,561 1.8 % (6,655 ) (1.3 )%
Provision (benefit) for income taxes 3,277 0.7 % (1,512 ) (0.3 )%
Net income (loss) $ 5,284 1.1 % $ (5,143 ) (1.0 )%
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Year Ended December 31,
2012 % of Sales 2011 % of Sales
Cost of sales $ 1,401 0.3 % $ 1,412 0.3 %
Selling, general and administrative 8,898 1.8 % 7,028 1.4 %
Research and development 675 0.1 % 668 0.1 %
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The following table sets forth our net sales by product line for the periods
indicated (in thousands) and the percentage of year-over-year change:
2012 2011 % Change
OrthoRecon
Hip $ 150,550 $ 173,201 (13.1 )%
Knees 114,896 123,988 (7.3 )%
Other 4,225 5,005 (15.6 )%
Total OrthoRecon 269,671 302,194 (10.8 )%
Extremities
Foot and Ankle 122,897 107,734 14.1 %
Upper Extremity 24,977 27,742 (10.0 )%
Biologics 60,495 69,409 (12.8 )%
Other 5,736 5,868 (2.2 )%
Total Extremities 214,105 210,753 1.6 %
Total Sales $ 483,776 $ 512,947 (5.7 )%
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The following table presents net sales by geographic area (in thousands) and the
percentage of year-over-year change:
2012 2011 % Change
Geographic
Domestic $ 275,686 $ 295,943 (6.8 )%
International 208,090 217,004 (4.1 )%
Total Sales $ 483,776 $ 512,947 (5.7 )%
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Net sales. Net sales totaled $483.8 million in 2012, compared to $512.9 million
in 2011, representing a 6% decline. U.S. net sales totaled $275.7 million in
2012, a 7% decline from $295.9 million in 2011, representing approximately 57%
of total net sales in 2012 and 58% of total net sales in 2011. Our international
net sales totaled $208.1 million in 2012, a 4% decrease as compared to net sales
of $217.0 million in 2011. Our 2012 international net sales included an
unfavorable foreign currency impact of approximately $5.3 million when compared
to 2011 net sales.
Extremities Segment: Net sales in our Extremities segment increased 2% to $214.1
million in 2012, from $210.8 million in 2011.
Our foot and ankle sales increased 14% to $122.9 million in 2012 from $107.7
million in 2011, driven by the success of our CLAW® II Polyaxial Compression
Plating System and our ORTHOLOC™ 3Di Reconstruction Plating System, both
launched in the first half of 2012, as well as the successful conversion of the
majority of our foot & ankle sales force to direct representation. International
foot and ankle sales grew 26%, as increased sales across all geographies were
partially offset by $0.8 million of unfavorable currency exchange rates.
Upper extremity net sales decreased to $25.0 million in 2012, representing a 10%
decline from 2011, driven by a 13% decline in the U.S.
Net sales of our biologics products decreased 13% to $60.5 million in 2012,
compared to $69.4 million in 2011. Our U.S. biologics sales declined 16% as a
result of lower sales volume due, in part, to the impact of the KCI agreement,
which precluded us from marketing our GRAFTJACKET® products in the wound care
field beginning July 1, 2011.
OrthoRecon Segment: Our OrthoRecon sales decreased 11% to $269.7 million in 2012
compared to $302.1 million in 2011.
Our hip product net sales totaled $150.6 million in 2012 compared to $173.2
million in 2011, representing a 13% decline. This decrease is attributable to an
18% decline in U.S. hip sales, driven primarily by a 12% decrease in sales
volume as the result of customer losses. International hip sales decreased by 8%
compared to 2011, driven by a 9% price decline in Japan due to lower
governmental reimbursement rates, and an 8% decrease in Europe driven primarily
by lower sales to our stocking distributors. In addition, international hip
sales were negatively impacted by $2.7 million of unfavorable currency exchange
rates.
Net sales of our knee products decreased 7% to $114.9 million in 2012 compared
to $124.0 million in 2011. In the U.S., knee sales decreased 13% from 2011, due
primarily to decreased sales volumes attributable to lost customers and sales
dis-synergies related to the U.S. sales force conversion initiative.
International knee sales were relatively flat, as an 8% increase in our European
direct markets and higher sales in our international stocking distributors were
offset by a 5% price decline in Japan due to lower governmental reimbursement
rates and $1.3 million of unfavorable currency exchange rates.
Cost of sales. Our cost of sales as a percentage of net sales increased slightly
in 2012 compared to 2011 from 30.6% to 31.0%, due to unfavorable geographic mix,
unfavorable currency exchange rates, and higher manufacturing expenses,
partially offset by decreased provisions for excess and obsolete inventory and
favorable product mix to our foot and ankle products.
Our cost of sales and corresponding gross profit percentages can be expected to
fluctuate in future periods depending upon changes in our product sales mix and
prices, distribution channels and geographies, manufacturing yields, period
expenses, levels of production volume and currency exchange rates.
Cost of sales - restructuring. In 2011, we recorded charges of $2.5 million for
excess and obsolete inventory provisions associated with product optimization as
. . .
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