Orthofix International N.V.
02/15/11

Orthofix International Announces 4th Quarter and Full Year 2010 Results

Full Year Revenues of $564.4 Million

Full Year Spine and Orthopedics Net Sales Each up 10%

LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix International N.V. (NASDAQ:OFIX) today announced its results for the fourth quarter and year ended December 31, 2010.

Reported net sales were $143.8 million and $564.4 million for the fourth quarter and full year ended December 31, 2010, respectively. Reported net income was $8.0 million, or $0.44 per diluted share, for the fourth quarter and $44.2 million, or $2.47 per diluted share, for the full year ended December 31, 2010.

"We continue to be encouraged by the growth in our Spinal Implants and Biologics business, as well as the return to positive growth for our Sports Medicine business, " said President and CEO Alan Milinazzo. "Additionally we continue to take the appropriate steps to improve our operating leverage which has allowed us to absorb higher costs associated with certain ongoing legal matters."

Sales Performance

Reported net sales were $143.8 million in the fourth quarter compared to $144.0 million in the fourth quarter of the prior year primarily as a result of the Company's exit from two of its non-strategic product lines. Further, foreign currency negatively impacted fourth quarter net sales by approximately $1.3 million or 1%. Excluding the impact of exiting the vascular and anesthesia product lines along with a prior year accounting adjustment for net sales in our Sports Medicine division, adjusted constant currency net sales increased 5% compared to the same period of the prior year.

Fourth quarter net sales in the Company's combined spine sector were up 6% to $78.7 million. Sales growth in our spine sector was driven by an 11% increase in implants and biologics revenue. The stimulation products used in spine applications growth slowed to 1%, primarily as a result of the ongoing industry wide investigation of the bone growth stimulation business and industry reimbursement challenges.

Reported fourth quarter net sales in the Company's orthopedic sector were $37.5 million, which was an increase of 5%, and represented growth of 8% on a constant currency basis compared to the prior year. This increase was led by its external fixation and deformity correction hardware platforms along with the increased use of Trinity® Evolution™ in orthopedic applications.

Reported net sales of the Company's sports medicine sector were $25.1 million, up 9% in the fourth quarter compared to the prior year. As previously noted, prior year sales were negatively impacted by an accounting adjustment. Excluding this adjustment, adjusted net sales of the Company's sports medicine sector returned to a positive growth of 3% in the fourth quarter compared to the prior year due to improved performances of its bracing and cold therapy product lines.

For the full year, net sales were $564.4 million, up 3% compared to the prior year on a reportable basis. The exit of the vascular and anesthesia product lines along with foreign currency negatively impacted full year 2010 and 2009 net sales by approximately $13.6 million and $30.5 million, respectively. Excluding the impact of exiting the vascular and anesthesia businesses, adjusted constant currency net sales increased 7% compared to the same period of the prior year.

The reconciliations of net sales to adjusted constant currency net sales have been included at the end of this press release.

Earnings Performance

Reported net income for the fourth quarter was down 16% to $8.0 million while net income per diluted share was down 19% to $0.44. Reported net income and net income per diluted share included the previously announced charge related to employee termination benefits of $3.6 million ($2.9 million, net of income taxes, or $0.16 per diluted share) associated with our internal reorganization, which will streamline operations and lower operating costs within the Company's three Global Business Units: Spine, Orthopedics and Sports Medicine. Also, included in reported net income was the previously disclosed patent dispute settlement charge of $2.0 million ($1.3 million, net of income taxes, or $0.07 per diluted share) concerning the Trinity® Evolution™ tissue allograft.

Adjusted net income and adjusted net income per diluted share for the fourth quarter increased 32% and 28%, respectively, compared to the prior year. The following table reconciles reported net income and net income per diluted share to adjusted net income and adjusted net income per diluted share for the fourth quarter ended December 31, 2010:

     
Fourth Quarter Adjusted Net Income and Adjusted Net Income per Diluted Share Q4 2010 Q4 2009 Difference
($000's)   EPS ($000's)   EPS Net Income   EPS
     
Reported GAAP net income and net income per diluted share $ 7,964 $ 0.44 $ 9,461 $ 0.55 -16 % -20 %
 

Specified Items:

 
Foreign exchange (gain) / loss $ (341 ) $ (0.02 ) $ 171 $ 0.01
Gain on interest rate swap - - $ (476 ) $ (0.03 )
Divested vascular product line $ 270 $ 0.02 - -
Reorganization costs $ 2,921 $ 0.16 - -
Patent dispute resolution $ 1,300 $ 0.07 - -
                                     
Adjusted net income and adjusted net income per diluted share $ 12,114     $ 0.68   $ 9,156     $ 0.53   32 %   28 %
 
Note: Some calculations may be impacted by rounding. Please refer to the Non-GAAP Performance Measure section at the end of this press release for more
information about the specified items listed above.

During the fourth quarter of 2010, the Company recorded $4.1 million ($2.7 million, net of income taxes, or $0.15 per diluted share) of legal expenses associated with the DOJ investigation of the bone growth stimulation industry and the Company's internal investigation into compliance with the Foreign Corrupt Practices Act at its distribution subsidiary in Mexico. These charges are included in both the reported and adjusted financial results.

The following table reconciles reported net income and net income per diluted share to adjusted net income and net income per diluted share for the year ended December 31, 2010:

     
Full Year Adjusted Net Income and Adjusted Net Income per Diluted Share 2010 2009 Difference
($000's)   EPS ($000's)   EPS Net Income   EPS
     
 
Reported GAAP net income and net income per diluted share $ 44,208 $ 2.47 $ 24,472 $ 1.42 81 % 74 %
 

Specified Items:

 
Foreign exchange loss $ 214 $ 0.01 $ 273 $ 0.02
Gain on interest rate swap $ (771 ) $ (0.04 ) $ (1,173 ) $ (0.07 )
Divested vascular product line $ (8,559 ) $ (0.48 ) - -
Reorganization costs $ 2,921 $ 0.16 $ 2,325 $ 0.14
Patent dispute resolution $ 1,300 $ 0.07 - -
Strategic investments - - $ 3,691 $ 0.21
Proxy contest - - $ 494 $ 0.03
                                     
Adjusted net income and adjusted net income per diluted share $ 39,313     $ 2.19   $ 30,082     $ 1.75   31 %   25 %
 
Note: Some calculations may be impacted by rounding. Please refer to the Non-GAAP Performance Measure section at the end of this press release for more
information about the specified items listed above.

2011 Outlook

In 2011, the Company expects to generate between $580 million and $590 million in net sales or 3% to 5% over reported net sales in 2010 which includes the continued reduction of vascular and anesthesia revenues reported as Other Products.

The Company expects both reported and adjusted net income 2011 to be between $2.60 and $2.70 per diluted share compared to reported net income of $2.47 per diluted share and adjusted net income of $2.19 per diluted share in 2010. This represents a 5% to 9% increase in reported net income per diluted share and an 18% to 23% increase in adjusted net income per diluted share compared to 2010.

The Company expects to incur approximately $8 million, or $0.26 per diluted share, of share-based compensation expense in 2011. This non-cash compensation expense is included in both the reported net income and adjusted net income per diluted share guidance for 2011.

The Company further expects an effective tax rate for 2011 of 38% to 40% due to its current geographical mix of earnings including jurisdictions in operating loss positions for which there is no tax benefit.

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company's financial results for the fourth quarter and full year of 2010. Interested parties may access the conference call by dialing (888) 267-2845 in the U.S. and (973) 413-6102 outside the U.S., and entering the conference ID 87421. A replay of the call will be available for two weeks by dialing (800) 332-6854 in the U.S. and (973) 528-0005 outside the U.S., and entering the conference ID 87421. A webcast of the conference call may be accessed by going to the Company's website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

About Orthofix

Orthofix International N.V. is a global medical device company offering a broad line of minimally invasive surgical, and non-surgical products for the spine, orthopedics, and sports medicine market sectors that address the lifelong bone-and-joint health needs of patients of all ages helping them achieve a more active and mobile lifestyle. Orthofix's products are widely distributed around the world to orthopedic surgeons and patients via Orthofix's sales representatives and its subsidiaries, including BREG, Inc., and via collaborations with other leading orthopedic product companies. In addition, Orthofix is collaborating on R&D activities with leading medical institutions such as the Musculoskeletal Transplant Foundation, the Orthopedic Research and Education Foundation, The University of Medicine and Dentistry of New Jersey and the National Osteoporosis Institute. For more information about Orthofix, please visit www.orthofix.com.

FORWARD-LOOKING STATEMENTS

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries and are based on management's current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the expected sales of its products, including recently launched products, unanticipated expenditures, changing relationships with customers, suppliers, strategic partners and lenders, changes to and the interpretation of governmental regulations, risks relating to the protection of intellectual property, changes to the reimbursement policies of third parties, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the orthopedic industry, credit markets and the economy, corporate development and market development activities, including acquisitions or divestitures, unexpected costs or operating unit performance related to recent acquisitions, and other factors described in our annual report on Form 10-K and other periodic reports filed by the Company with the Securities and Exchange Commission (SEC).

The Company cannot predict the timing or outcome of ongoing litigation matters and governmental investigations of our businesses which could result in civil or criminal liability or findings of violations of law (as further described in the "Legal Proceedings" sections of our annual report on Form 10-K, quarterly reports on Form 10-Q), that could materially impact our financial position and/or liquidity.

     
ORTHOFIX INTERNATIONAL N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, U.S. Dollars, in thousands, except per share and share data)
 
 
Three Months Ended December 31, Twelve Months Ended December 31,
2010 2009 2010 2009
 
Net sales $143,796 $144,016 $564,370 $545,635
Cost of sales 32,669 36,749 131,716 138,450
Gross profit 111,127 107,267 432,654 407,185
 
Operating expenses
Sales and marketing 60,186 53,396 230,942 215,943
General and administrative 25,218 24,171 88,628 88,866
Research and development 7,077 5,624 30,350 31,460
Amortization of intangible assets 1,505 2,097 5,763 7,041
Other Income/(Expense)Net gain on sale of vascular operations 300 0 (12,019) 0
94,286 85,288 343,664 343,310
 
Operating income 16,841 21,979 88,990 63,875
 
Other income and expense
Interest expense, net (2,127) (6,242) (16,898) (24,627)
Other income (expense), net 507 (494) (398) (1,079)
Loss on refinancing of senior secured term loan 0 0 (550) 0
Gain on interest rate swap 0 806 1,254 1,852
Other expense, net (1,620) (5,930) (16,592) (23,854)
Income before income taxes 15,221 16,049 72,398 40,021
Income tax expense (7,257) (6,588) (28,190) (15,549)
Net income $7,964 $9,461 $44,208 $24,472
 
Net income per common share - basic $0.45 $0.55 $2.51 $1.43
 
Net income per common share - diluted $0.44 $0.55 $2.47 $1.42
 
Weighted average number of common 17,710,377 17,135,542 17,601,956 17,119,474
shares outstanding - basic
 
Weighted average number of common
shares outstanding - diluted 17,912,059 17,301,659 17,913,545 17,202,943
ORTHOFIX INTERNATIONAL N.V.    
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, U.S. Dollars, in thousands)
 
 
December 31, December 31,
2010 2009
 
Assets
Current assets:
Cash and cash equivalents $13,561 $13,328
Restricted cash 22,944 11,630
Trade accounts receivable, net 134,184 129,777
Inventories, net 84,589 94,624
Deferred income taxes 17,422 20,286
Prepaid expenses and other current assets 39,060 29,849
Total current assets 311,760 299,494
 
Property, plant and equipment, net 45,535 38,694
Patents and other intangible assets, net

41,457

47,628
Goodwill 176,497 185,175
Deferred taxes and other long-term assets 28,740 19,482
 
Total assets $603,989 $590,473
 
 
Liabilities and shareholders' equity
Current liabilities:
Bank borrowings $3,812 $2,209
Current portion of long-term debt 7,500 3,332
Trade accounts payable 19,796 23,302
Other current liabilities 52,418 59,210
Total current liabilities 83,526 88,053
 
Long-term debt 208,695 249,132
Deferred income taxes 8,102 6,115
Other long-term liabilities 2,775 6,904
Total liabilities 303,098 350,204
 
Shareholders' equity:
Common shares 1,772 1,714
Additional paid-in capital 195,402 177,246
Retained earnings 98,327 54,119
Accumulated other comprehensive income 5,390   7,190
Total shareholders' equity 300,891 240,269
 
Total liabilities and shareholders' equity $603,989 $590,473
 
ORTHOFIX INTERNATIONAL N.V.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, U.S. Dollars, in thousands)
 
Twelve Months Ended December 31,
2010 2009
 
Cash flows from operating activities:
Net income $44,208 $24,472
Adjustments to reconcile net income to net cash
provided by operating activities:
Depreciation and amortization 22,521 22,344
Other non-cash adjustments 8,152 23,350
Changes in working capital (32,407) (19,584)
Net cash provided by operating activities 42,474 50,582
 
Cash flows from investing activities:
Capital expenditures (26,361) (21,998)
Investment in collaborative arrangements - (2,000)
Proceeds from sale of investments held at cost - 1,711
Net proceeds from sale of assets, principally vascular operations 24,215 -
Net cash used in investing activities (2,146) (22,287)
 
Cash flows from financing activities:
Net proceeds from issuance of common shares 7,854 70
Repayments of long-term debt (36,269) (28,323)
Payment of refinancing fees (4,232) -
Proceeds from bank borrowings, net 1,723 248
Restricted cash * (11,290) (612)
Cash payment for purchase of minority interest in subsidiary - (1,143)
Repurchase of equity - (220)
Tax benefit on non-qualified stock options 2,222 25
Net cash used in financing activities (39,992) (29,955)
 
Effect of exchange rate changes on cash (103) 394
 
Net increase (decrease) in cash and cash equivalents 233 (1,266)
Cash and cash equivalents at the beginning of the year 13,328 14,594
Cash and cash equivalents at the end of the year $13,561 $13,328
 

* - The Company has reclassified its restricted cash from operating activities to financing activities for
the years end December 31, 2010 and 2009. The Company deemed this as the more appropriate disclosure
since the cash is restricted for use by only those parties included in the Credit Facilities.

             
External net sales by market sector
(U.S. Dollars in millions)
 
Three Months Ended December 31, Twelve Months Ended December 31,  
Constant Constant
Reported Currency Reported Currency
2010 2009 Growth Growth 2010 2009 Growth Growth
 
Spine
Stimulation $ 42.4 $ 41.9 1 % 1 % $ 172.5 $158.8 9 % 9 %
Implants and Biologics   36.3   32.6 11 % 11 %   133.9 120.6 11 % 11 %
Total Spine 78.7 74.5 6 % 6 % 306.4 279.4 10 % 10 %
 
Orthopedics 37.5 35.8 5 % 8 % 144.4 131.3 10 % 10 %
 
Sports Medicine 25.1 23.0 9 % 9 % 95.5 96.4 -1 % -1 %
 
Other Products *   2.5   10.8 -77 % -76 %   18.1 38.5 -53 % -53 %
 
Total $ 143.8 $ 144.0 0 % 1 % $ 564.4 $545.6 3 % 3 %
 
Note: Some calculations may be impacted by rounding.

*- Includes sales of the divested vascular and exited anesthesia businesses.

Non-GAAP Performance Measures

The tables below present reconciliations of fourth quarter and full year net sales, net income and net income per diluted share calculated in accordance with generally accepted accounting principles (GAAP) to non-GAAP performance measures, referred to as "Adjusted Constant Currency Net Sales" and "Adjusted Net Income and Adjusted Net Income per Diluted Share" that exclude the items specified in the tables. The Regulation G Supplemental Information Schedule attached to this release includes additional reconciliations between GAAP measures and non-GAAP measures referred to as "Adjusted Consolidated EBITDA" and "Adjusted Sports Medicine Net Sales". Management believes it is important to provide investors with the same non-GAAP metrics it uses to supplement information regarding the performance and underlying trends of Orthofix's business operations in order to facilitate comparisons to its historical operating results and internally evaluate the effectiveness of the Company's operating strategies. A more detailed explanation of the items in the tables below that are excluded from GAAP net sales and GAAP net income and net income per diluted share, as well as why management believes the non-GAAP measures are useful to them, is included in the Regulation G Supplemental Information schedule attached to this press release.

Reconciliations of Non-GAAP Performance Measures

Adjusted Net Income and Adjusted Net Income per Diluted Share Reconciling Items

Note: The reconciling items were tax affected in the current year at the prevailing rate within the respective jurisdictions.

     
Fourth Quarter Adjusted Constant Currency Net Sales
 
(USD in million) Q4 10 Q4 09 Difference
 
Reported GAAP net sales $ 143.8 $ 144.0 0 %
 

Specified Items:

 
Divested vascular product line (1.7 ) (6.1 )
Exited anesthesia product line - (2.5 )
Impact of change in Breg distributor recognition   -     1.2  
Adjusted net sales 142.1 136.6 4 %
 
Foreign currency impact   1.3     -  
Adjusted constant currency net sales $ 143.4   $ 136.6   5 %
 
Note: Some calculations may be impacted by rounding.
     
Full Year Adjusted Constant Currency Net Sales
 
(USD in million) 2010 2009 Difference
 
Reported GAAP net sales $ 564.4 $ 545.6 3 %
 

Specified Items:

 
Divested vascular product line (8.3 ) (18.7 )
Exited anesthesia product line   (5.0 )   (11.8 )
Adjusted net sales 551.1 515.2 7 %
 
Foreign currency impact   (0.3 )   -  
Adjusted constant currency net sales $ 550.8   $ 515.2   7 %
 
Note: Some calculations may be impacted by rounding.
     
Fourth Quarter Adjusted Sports Medicine Net Sales
 
(USD in million) Q4 10   Q4 09   Difference
 
Reported GAAP net sales $ 25.1 $ 23.0 9 %
 

Specified Items:

 
Impact of change in Breg distributor recognition - 1.2
               
Adjusted net sales $ 25.1   $ 24.2   4 %

Adjusted Constant Currency Net Sales Reconciling Items

   
Adjusted Consolidated EBITDA
Q4 10 TTM 12/31/10
($000's) ($000's)
Net Income $ 7,964 $ 44,208
 
Depreciation and amortization 7,012 22,521
Interest expense 1,971 16,898
Loss on refinancing of senior secured term loan - 550
Gain on interest rate swap - (1,254 )
Tax expense 7,257 28,190
Share-based compensation 1,013 8,138
Net gain on sale of vascular operations 300 (12,019 )
Other non-cash items   (399 )   400  
 
Adjusted Consolidated EBITDA $ 25,118   $ 107,632  

NOTE: Adjusted Consolidated EBITDA is computed pursuant to the definition of "Consolidated EBITDA" contained in the Company's credit agreement, dated August 30, 2010. The credit agreement was filed as Exhibit 10.1 to Company's current report on Form 8-K filed on August 31, 2010. This document can be found at the SEC's website at www.SEC.gov.

Adjusted Consolidated EBITDA

Management use of, and economic substance behind, Non-GAAP Performance Measures

Management uses non-GAAP measures to evaluate performance period over period, to analyze the underlying trends in the Company's business, to assess its performance relative to its competitors and to establish operational goals and forecasts that are used in allocating resources. In addition, following the Company's acquisition of Blackstone Medical, and the related increase in Orthofix's debt, management has increased its focus on cash generation and debt reduction. Management uses these non-GAAP measures as the basis for assessing the ability of the underlying operations to generate cash for use in paying down debt. In addition, management uses these non-GAAP measures to further its understanding of the performance of the Company's business segments. The items excluded from Orthofix's non-GAAP measures are also excluded from the profit or loss reported by the Company's business segments for the purpose of analyzing their performance.

Material Limitations Associated with the Use of Non-GAAP Measures

The non-GAAP measures used in this release may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP performance measures. Some of the limitations associated with the use of these non-GAAP performance measures are that they exclude items that reflect an economic cost to the Company and can have a material effect on cash flows. Similarly, equity compensation expense does not directly impact cash flows, but is part of total compensation costs accounted for under GAAP.

Compensation for Limitations Associated with Use of Non-GAAP Measures

Orthofix compensates for the limitations of its non-GAAP performance measures by relying upon its GAAP results to gain a complete picture of the Company's performance. The GAAP results provide the ability to understand the Company's performance based on a defined set of criteria. The non-GAAP measures reflect the underlying operating results of the Company's businesses, excluding non-cash items, which management believes is an important measure of the Company's overall performance. The Company provides a detailed reconciliation of the non-GAAP performance measures to their most directly comparable GAAP measures, and encourages investors to review this reconciliation.

Usefulness of Non-GAAP Measures to Investors

Orthofix believes that providing non-GAAP measures that exclude certain items provides investors with greater transparency to the information used by the Company's senior management in its financial and operational decision-making. Management believes that providing this information enables investors to better understand the performance of the Company's ongoing operations and to understand the methodology used by management to evaluate and measure such performance. Disclosure of these non-GAAP performance measures also facilitates comparisons of Orthofix's underlying operating performance with other companies in its industry that also supplement their GAAP results with non-GAAP performance measures.

Source: Orthofix International N.V.

Orthofix International N.V.
Brian McCollum, 214-937-2927
brianmccollum@orthofix.com

Source: Orthofix International N.V.

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