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8-K - FORM 8-K - WRIGHT MEDICAL GROUP INCform8-kq32011pressrelease.htm


FOR RELEASE 3:00 P.M. CENTRAL
November 1, 2011
Contact: Julie Tracy
Sr. Vice President, Chief Communications Officer
Wright Medical Group, Inc.
(901) 290-5817
julie.tracy@wmt.com


Wright Medical Group, Inc. Reports 2011 Third Quarter Results and Provides Outlook for Remainder of Year

Third Quarter Adjusted EPS Increases 5% to $0.20

ARLINGTON, TN - November 1, 2011 - Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company and a leading provider of surgical solutions for the foot and ankle market, today reported financial results for its third quarter ended September 30, 2011 and provided financial guidance for 2011.

Net sales totaled $118.2 million during the third quarter ended September 30, 2011, representing a 3% decrease over net sales of $121.7 million during the third quarter of 2010. Excluding the impact of foreign currency, net sales decreased 6% in the third quarter of 2011, as compared to the same period last year. During the third quarter of 2011, U.S. sales were negatively affected by distributor transitions and challenges associated with implementing enhancements to the Company's compliance processes. As anticipated, these challenges have resulted in a slowdown in medical education and research and development projects. Additionally, net sales results continue to be affected by procedure softness across all product lines.

Net loss for the third quarter of 2011 totaled $16.0 million or $0.42 per diluted share, compared to net income of $4.7 million or $0.12 per diluted share in the third quarter of 2010.

Net loss for the third quarter of 2011 included the after-tax effects of $14.0 million of charges associated with the previously announced cost restructuring plan, an approximately $13.2 million charge for management's estimate of the Company's total liability for claims associated with previous and estimated future fractures of its titanium PROFEMUR® long modular necks in North America, $5.0 million of expenses associated with the Company's deferred prosecution agreement (DPA), $2.2 million of non-cash stock-based compensation expense, and $2.0 million of expenses related to settlement of certain employment matters and the hiring of a new chief executive officer (CEO). Net income for the third quarter of 2010 included the after-tax effects of approximately $3.1 million of non-cash stock-based compensation expense, $942,000 of expenses related to the U.S. governmental inquiry, and $134,000 of restructuring charges.

The Company's third quarter net income, as adjusted, increased 7% to $7.7 million in 2011 from $7.3 million in 2010, while diluted earnings per share, as adjusted, increased 5% to $0.20 in the third quarter of 2011 from $0.19 in the third quarter of 2010. A reconciliation of U.S. GAAP to “as adjusted” results is included in the attached financial tables.

Robert Palmisano, President and CEO, commented, “We are clearly facing some challenges, which are reflected in our third quarter results and our outlook for the remainder of the year.  However, Wright Medical is a company with great promise. We have excellent products and technologies across our orthopaedic businesses, and we are the recognized leader in the foot and ankle market. In addition, we have recently taken many positive steps to better position the Company for success, including strengthening our compliance

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program and implementing a plan to reduce operational costs. My top priorities will be to continue building on this progress and focusing on areas where we can win, including growing our foot and ankle business above market rates, running a much more focused and efficient recon business, and improving our balance sheet to increase cash generation. I believe these initiatives will in turn drive growth and shareholder value.”

Palmisano continued, “In resetting our guidance, we took into account the factors that are expected to affect our business for the remainder of the year, including procedure softness globally, as well as challenges associated with implementing enhancements to our compliance processes and distributor transitions. I am confident that we will be able to capitalize on the market opportunities and work towards building a leading global orthopaedic organization.”

Outlook

The Company is updating its 2011 net sales outlook to $505 million to $509 million, representing annualized growth expectations of -3% to -2% as compared to 2010. The Company is also adjusting its 2011 as-adjusted earnings per share outlook to a target range for the full year 2011 of $0.80 to $0.84 per diluted share. The Company's current outlook for adjusted earnings per share represents annualized growth expectations of -11% to -7%.
 
The Company's earnings target excludes the transaction costs and non-cash deferred financing fees associated with the Convertible Notes tendered, costs associated with the previously announced cost restructuring, expenses associated with settlements of certain employment matters and the hiring of a new CEO, charges associated with the Company's liability for PROFEMUR® long modular neck claims, possible future acquisitions, other material future business developments, non-cash stock-based compensation expense, and costs associated with the Company's DPA (including the associated independent monitor).
 
While the amount of the non-cash stock-based compensation charges will vary depending upon a number of factors, the Company currently estimates that the after-tax impact of those expenses will be approximately $0.17 per diluted share for the full year 2011. Therefore, the Company anticipates full year 2011 as-adjusted earnings per share including stock-based compensation to be in the range of $0.63 to $0.67 per diluted share, which represents annualized growth of -10% to -4%.

With regard to restructuring charges, the Company continues to anticipate incurring pre-tax restructuring charges related to the cost restructuring plan announced in September 2011 to range from $25 million to $30 million, of which $14.0 million of these charges have been incurred to date. The Company expects to record the majority of these charges by the end of 2011, with some additional charges to be recorded during the first half of 2012.

The Company's anticipated ranges for net sales, adjusted earnings per share, non-cash stock-based compensation charges, and restructuring charges are forward-looking statements. They are subject to various risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated targets. The anticipated targets are not predictions of the Company's actual performance. See the cautionary information about forward-looking statements in the “Safe-Harbor Statement” section of this press release.

Conference Call

As previously announced, the Company will host a conference call starting at 3:30 p.m. (Central Time) today. The live dial-in number for the call is 866-788-0540 (domestic) or 857-350-1678 (international). The participant passcode for the call is “Wright.” To access a simultaneous webcast of the conference call via the

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internet, go to the “Corporate - Investor Information” section of the Company's website located at www.wmt.com. A replay of the conference call by telephone will be available starting at 6:30 p.m. (Central Time) today and continuing until November 8, 2011. To hear this replay, dial 888-286-8010 (domestic) or 617-801-6888 (international) and enter the passcode 19646025. A replay of the conference call will also be available via the internet starting today and continuing for at least 12 months. To access a replay of the conference call via the internet, go to the “Corporate - Investor Information - Audio Archives” section of the Company's website located at www.wmt.com.

The conference call may include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, the Form 8-K filed with the SEC today, or otherwise available in the “Corporate - Investor Information - Supplemental Financial Information” section of the Company's website located at www.wmt.com.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the “Safe-Harbor Statement” section of this press release.

Non-GAAP Financial Measures

The Company uses non-GAAP financial measures, such as net sales, excluding the impact of foreign currency; operating income, as adjusted; net income, as adjusted; net income, as adjusted, per diluted share; effective tax rate, as adjusted; and free cash flow. The Company's management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company's operations, period over period. The measures exclude such items as costs related to the U.S. governmental inquiries and the DPA, restructuring charges, transaction costs, charges associated with the Company's liability for PROFEMUR® long modular neck claims, costs related to settlement of certain employment matters and the hiring of a new CEO, and non-cash stock-based expense, all of which may be highly variable, difficult to predict and of a size that could have substantial impact on the Company's reported results of operations for a period. Management uses these measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as defined under U.S. federal securities laws, including statements regarding potential actions by the USAO, independent monitor, OIG and other agencies or their potential impact. These statements reflect management's current knowledge, assumptions, beliefs, estimates, and expectations and express management's current views of future performance, results, and trends and may be identified by their use of terms such as anticipate, believe, could, estimate, expect, intend, may, plan, predict, project, will, and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements. The reader should not place undue reliance on forward-looking statements. Such statements are made as of the date of this press release, and we undertake no obligation to update such statements after this date. Risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include those discussed in our filings with the Securities and Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2010, and our

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subsequently filed quarterly reports, under the heading “Risk Factors” and elsewhere); future actions of the FDA or any other regulatory body or government authority that could delay, limit or suspend product development, manufacturing or sale or result in seizures, injunctions, monetary sanctions or criminal or civil liabilities; the impact of any such future actions of the FDA or any other regulatory body or government authority on our settlement of the federal investigation into our consulting arrangements with orthopaedic surgeons relating to our hip and knee products in the United States; and the impact of such settlement of the federal investigation into our consulting arrangements with orthopaedic surgeons relating to our hip and knee products in the United States, including our compliance with the Deferred Prosecution Agreement through September 2012 and the Corporate Integrity Agreement through September 2015. Our failure to comply with the Deferred Prosecution Agreement or the Corporate Integrity Agreement 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, including under the previously-filed criminal complaint, civil and criminal fines or penalties, and additional litigation cost and expense. In addition, a breach of the DPA or the CIA could result in an event of default under the Senior Credit Facility, which in turn could result in an event of default under the Indenture.

Additional risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include the possibility of litigation brought by shareholders, including private securities litigation and shareholder derivative suits, which if initiated, could divert management's attention, harm our business and/or reputation and result in significant liabilities; demand for and market acceptance of our new and existing products; future actions of governmental authorities and other third parties; tax measures; business development and growth opportunities; product quality or patient safety issues; products liability claims; enforcement of our intellectual property rights; the geographic and product mix impact on our sales; retention of sales representatives and independent distributors; inventory reductions or fluctuations in buying patterns by wholesalers or distributors; ability to realize the anticipated benefits of restructuring initiatives; impact of the commercial and credit environment on us and our customers and suppliers; and in the implementation of our new compliance enhancements, including the duration and severity of delays related to medical education, research and development and clinical studies, and the impact of any such delays on our relationships with customers. 

Wright Medical Group, Inc. is a global orthopaedic medical device company and a leading provider of surgical solutions for the foot and ankle market. The Company specializes in the design, manufacture and marketing of devices and biologic products for extremity, hip and knee repair and reconstruction. The Company has been in business for more than 60 years and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit the Company's website at www.wmt.com.

--Tables Follow--



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Wright Medical Group, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data--unaudited)

 
Three Months Ended
 
Nine Months Ended
 
September 30, 2011
 
September 30, 2010
 
September 30, 2011
 
September 30, 2010
Net sales
$
118,184

 
$
121,708

 
$
386,075

 
$
380,686

Cost of sales
36,185

 
37,989

 
116,457

 
118,064

Cost of sales - restructuring
1,900

 

 
1,900

 

Gross profit
80,099

 
83,719

 
267,718

 
262,622

Operating expenses:
 
 
 
 
 
 
 
Selling, general and administrative
83,581

 
64,877

 
229,227

 
209,089

Research and development
6,769

 
8,779

 
23,783

 
28,398

Amortization of intangible assets
721

 
708

 
2,088

 
1,991

Restructuring charges
12,132

 
134

 
12,132

 
1,139

Total operating expenses
103,203

 
74,498

 
267,230

 
240,617

Operating (loss) income
(23,104
)
 
9,221

 
488

 
22,005

Interest expense, net
1,464

 
1,532

 
4,774

 
4,550

Other expense, net
59

 
313

 
4,775

 
270

(Loss) income before income taxes
(24,627
)
 
7,376

 
(9,061
)
 
17,185

(Benefit) provision for income taxes
(8,582
)
 
2,726

 
(2,755
)
 
8,213

Net (loss) income
$
(16,045
)
 
$
4,650

 
$
(6,306
)
 
$
8,972

Net (loss) income per share, basic
$
(0.42
)
 
$
0.12

 
$
(0.16
)
 
$
0.24

Net (loss) income per share, diluted
$
(0.42
)
 
$
0.12

 
$
(0.16
)
 
$
0.24

Weighted-average number of shares outstanding-basic
38,406

 
37,935

 
38,228

 
37,748

Weighted-average number of shares outstanding-diluted
38,406

 
38,011

 
38,228

 
37,923


Wright Medical Group, Inc.
Consolidated Sales Analysis
(dollars in thousands--unaudited)
 
Three Months Ended
 
Nine Months Ended
 
September 30, 2011
 
September 30, 2010
 
%
change
 
September 30, 2011
 
September 30, 2010
 
%
change
Geographic
 
 
 
 
 
 
 
 
 
 
 
Domestic
$
69,382

 
$
74,594

 
(7.0
%)
 
$
222,678

 
$
228,803

 
(2.7
%)
International
48,802

 
47,114

 
3.6
%
 
163,397

 
151,883

 
7.6
%
Total net sales
$
118,184

 
$
121,708

 
(2.9
%)
 
$
386,075

 
$
380,686

 
1.4
%
 
 
 
 
 
 
 
 
 
 
 
 
Product Line
 
 
 
 
 
 
 
 
 
 
 
Hip products
$
39,045

 
$
39,956

 
(2.3
%)
 
$
130,486

 
130,418

 
0.1
%
Knee products
27,204

 
29,549

 
(7.9
%)
 
93,429

 
93,742

 
(0.3
%)
Extremity products
32,373

 
30,125

 
7.5
%
 
99,399

 
89,738

 
10.8
%
Biologics products
16,610

 
19,666

 
(15.5
%)
 
53,846

 
59,296

 
(9.2
%)
Other
2,952

 
2,412

 
22.4
%
 
8,915

 
7,492

 
19.0
%
Total net sales
$
118,184

 
$
121,708

 
(2.9
%)
 
$
386,075

 
$
380,686

 
1.4
%



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Wright Medical Group, Inc.
Supplemental Sales Information
(unaudited)
 
Third Quarter 2011 Sales Growth
 
Domestic
As
Reported
Int'l
Constant
Currency
Int'l
As
Reported
Total
Constant
Currency
Total
As
Reported
Hips
(14%)
(2%)
6%
(7%)
(2%)
Knees
(7%)
(13%)
(9%)
(10%)
(8%)
Extremities
5%
9%
18%
6%
7%
Biologics
(20%)
4%
8%
(16%)
(16%)
Total
(7%)
(3%)
4%
(6%)
(3%)


 
Sales as a % of Total Sales
 
Three Months Ended
September 30, 2011
 
Nine Months Ended
September 30, 2011
 
Domestic
International
Total
 
Domestic
International
Total
Hips
12%
21%
33%
 
12%
22%
34%
Knees
13%
10%
23%
 
13%
11%
24%
Extremities
22%
6%
27%
 
20%
5%
26%
Biologics
11%
3%
14%
 
11%
3%
14%
Total
59%
41%
100%
 
58%
42%
100%




Wright Medical Group, Inc.
Reconciliation of Net Sales to Net Sales Excluding the Impact of Foreign Currency
(dollars in thousands--unaudited)
 
Three Months Ended
 
Nine Months Ended
 
September 30, 2011
 
September 30, 2011
 
International Net Sales
 
Total
Net Sales
 
International Net Sales
 
Total
Net Sales
Net sales, as reported
$
48,802

 
$
118,184

 
$
163,397

 
$
386,075

Currency impact as compared to prior period
(3,189
)
 
(3,189
)
 
(9,755
)
 
(9,755
)
Net sales, excluding the impact
of foreign currency
$
45,613

 
$
114,995

 
$
153,642

 
$
376,320




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Wright Medical Group, Inc.
Reconciliation of As Reported Results to Non-GAAP Financial Measures
(in thousands, except per share data--unaudited)
 
Three Months Ended
 
Nine Months Ended
 
September 30, 2011
 
September 30, 2010
 
September 30, 2011
 
September 30, 2010
Operating Income
 
 
 
 
 
 
 
Operating income, as reported
$
(23,104
)
 
$
9,221

 
$
488

 
$
22,005

Reconciling items impacting Gross Profit:
 
 
 
 
 
 
 
Non-cash, stock-based compensation
356

 
314

 
1,063

 
980

Cost of sales - restructuring
1,900

 

 
1,900

 

Employment matters (1)
99

 

 
99

 

Total
2,355

 
314

 
3,062

 
980

Reconciling items impacting Selling, General and Administrative expenses:
 
 
 
 
 
 
 
Non-cash, stock-based compensation
1,715

 
2,261

 
5,083

 
7,700

U.S. governmental inquiries/DPA related
4,974

 
942

 
9,541

 
9,619

Employment matters (1)
1,783

 

 
1,783

 

Product liability provision
13,199

 

 
13,199

 

Total
21,671

 
3,203

 
29,606

 
17,319

Reconciling items impacting Research and Development expenses:
 
 
 
 
 
 
 
Non-cash, stock-based compensation
150

 
492

 
542

 
1,500

Employment matters (1)
135

 

 
135

 

Total
285

 
492

 
677

 
1,500

Other Reconciling Items:
 
 
 
 
 
 
 
Restructuring charges
12,132

 
134

 
12,132

 
1,139

Operating income, as adjusted
$
13,339

 
$
13,364

 
$
45,965

 
$
42,943

Operating income, as adjusted, as a
percentage of net sales
11.3
%
 
11.0
%
 
11.9
%
 
11.3
%

_______________________________

(1) Costs associated with settlement of certain employment matters and the hiring of a new CEO.

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Wright Medical Group, Inc.
Reconciliation of As Reported Results to Non-GAAP Financial Measures
(in thousands, except per share data--unaudited)
 
Three Months Ended
 
Nine Months Ended
 
September 30, 2011
 
September 30, 2010
 
September 30, 2011
 
September 30, 2010
Net Income
 
 
 
 
 
 
 
Income before taxes, as reported
$
(24,627
)
 
$
7,376

 
$
(9,061
)
 
$
17,185

Pre-tax impact of reconciling items:

 

 

 

Non-cash, stock-based compensation
2,221

 
3,067

 
6,688

 
10,180

U.S. governmental inquiries/DPA related
4,974

 
942

 
9,541

 
9,619

Deferred financing fees and transaction costs associated with Convertible Notes Tender Offer

 

 
4,099

 

Restructuring charges
14,032

 
134

 
14,032

 
1,139

Employment matters (1)
2,017

 

 
2,017

 

Product liability provision
13,199

 

 
13,199

 

Income before taxes, as adjusted
11,816

 
11,519

 
40,515

 
38,123

 

 

 

 

Provision for income taxes, as reported
(8,582
)
 
2,726

 
(2,755
)
 
8,213

Non-cash, stock-based compensation
744

 
1,116

 
2,093

 
3,266

U.S. governmental inquiries/DPA related
1,873

 
369

 
3,371

 
2,185

Deferred financing fees and transaction costs associated with Convertible Notes Tender Offer

 

 
1,599

 

Restructuring charges
4,574

 
52

 
4,574

 
443

Employment matters (1)
720

 

 
720

 

Product liability provision
4,740

 

 
4,740

 

Provision for income taxes, as adjusted
$
4,069

 
$
4,263

 
$
14,342

 
$
14,107

Effective tax rate, as adjusted
34.4
%
 
37.0
%
 
35.4
%
 
37.0
%
Net income, as adjusted
$
7,747

 
$
7,256

 
$
26,173

 
$
24,016


_______________________________

(1) Costs associated with settlement of certain employment matters and the hiring of a new CEO.



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Wright Medical Group, Inc.
Reconciliation of As Reported Results to Non-GAAP Financial Measures
(continued)

 
Three Months Ended
 
Three Months Ended
 
September 30, 2011
 
September 30, 2010
 
As Reported
 
As Adjusted
 
As Reported
 
As Adjusted
Basic net income
$
(16,045
)
 
$
7,747

 
$
4,650

 
$
7,256

Interest expense on convertible notes
N/A

 
137

 
N/A

 
935

Diluted net income
$
(16,045
)
 
$
7,884

 
$
4,650

 
$
8,191

 


 


 


 


Basic shares
38,406

 
38,406

 
37,935

 
37,935

Dilutive effect of stock options and restricted shares

 
130

 
76

 
76

Dilutive effect of convertible notes
N/A

 
891

 
N/A

 
6,126

Diluted shares
38,406

 
39,427

 
38,011

 
44,137

 


 


 


 


Net income per share, diluted
$
(0.42
)
 
$
0.20

 
$
0.12

 
$
0.19



 
Nine Months Ended
 
Nine Months Ended
 
September 30, 2011
 
September 30, 2010
 
As Reported
 
As Adjusted
 
As Reported
 
As Adjusted
Basic net income
$
(6,306
)
 
$
26,173

 
$
8,972

 
$
24,016

Interest expense on convertible notes
N/A

 
1,066

 
N/A

 
2,805

Diluted net income
$
(6,306
)
 
$
27,239

 
$
8,972

 
$
26,821

 


 


 


 


Basic shares
38,228

 
38,228

 
37,748

 
37,748

Dilutive effect of stock options and restricted shares

 
149

 
175

 
175

Dilutive effect of convertible notes
N/A

 
2,249

 
N/A

 
6,126

Diluted shares
38,228

 
40,626

 
37,923

 
44,049

 


 


 


 


Net income per share, diluted
$
(0.16
)
 
$
0.67

 
$
0.24

 
$
0.61



 
Three Months Ended
 
Nine Months Ended
 
September 30, 2011
 
September 30, 2010
 
September 30, 2011
 
September 30, 2010
Net Income per Diluted Share
 
 
 
 
 
 
 
Net (loss) income, as reported, per
diluted share
$
(0.42
)
 
$
0.12

 
$
(0.16
)
 
$
0.24

Interest expense on convertible notes
0.00

 
0.02

 
0.03

 
0.06

Effect of convertible notes on diluted shares
0.01

 
(0.02
)
 
0.01

 
(0.03
)
Non-cash, stock-based compensation
0.04

 
0.05

 
0.11

 
0.16

Restructuring charges
0.24

 
0.00

 
0.23

 
0.02

Deferred financing fees and transaction costs associated with Convertible Notes Tender Offer

 

 
0.06

 

U.S. governmental inquiries/DPA related
0.08

 
0.01

 
0.15

 
0.17

Employment matters (1)
0.03

 

 
0.03

 

Product liability
0.22

 

 
0.21

 

Net income, as adjusted, per
diluted share
$
0.20

 
$
0.19

 
$
0.67

 
$
0.61

_______________________________

(1) Costs associated with settlement of certain employment matters and the hiring of a new CEO.



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Wright Medical Group, Inc.
Condensed Consolidated Balance Sheets
(dollars in thousands--unaudited)

 
September 30, 2011
 
December 31, 2010
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
156,141

 
$
153,261

Marketable securities
15,740

 
19,152

Accounts receivable, net
97,328

 
105,336

Inventories
171,690

 
166,339

Prepaid expenses and other current assets
62,069

 
53,502

Total current assets
502,968

 
497,590

 
 
 
 
Property, plant and equipment, net
163,361

 
158,247

Goodwill and intangible assets, net
70,256

 
70,673

Marketable securities
6,989

 
17,193

Other assets
9,994

 
11,536

Total assets
$
753,568

 
$
755,239

 
 
 
 
Liabilities and stockholders' equity
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
17,001

 
$
15,862

Accrued expenses and other current liabilities
65,027

 
54,409

Current portion of long-term obligations
8,550

 
1,033

Total current liabilities
90,578

 
71,304

Long-term obligations
168,975

 
201,766

Other liabilities
25,326

 
11,197

Total liabilities
284,879

 
284,267

 
 
 
 
Stockholders' equity
468,689

 
470,972

Total liabilities and stockholders' equity
$
753,568

 
$
755,239


 

 ###

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