Orthofix International N.V.
02/23/12

Orthofix International Announces 4th Quarter and Full Year 2011 Results

Q4 Earnings per diluted share up 49% to $0.66; Q4 Adjusted Earnings per diluted share up 18% to $0.80

LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix International N.V. (NASDAQ:OFIX) (the Company) today announced its results for the fourth quarter and year ended December 31, 2011.

Net sales were $151.5 million and $579.0 million for the fourth quarter and full year ended December 31, 2011, respectively. Net income was $12.4 million, or $0.66 per diluted share, for the fourth quarter and net loss was $1.1 million, or $0.06 per diluted share, for the full year ended December 31, 2011. Adjusted net income was $14.9 million, or $0.80 per diluted share, for the fourth quarter and $51.1 million, or $2.75 per diluted share, for the full year ended December 31, 2011.

Robert Vaters, President and Chief Executive Officer, commented, "2011 was an important year of transition for the Company highlighted by several key achievements that together represent an important point of inflection for the Company. We are now well positioned to focus on long term revenue growth across our Regenerative and Repair product platforms, all while continuing to deliver on our commitment of growing our earnings in excess of our sales."

Sales Performance

Net sales were $151.5 million in the fourth quarter of 2011, up 5% from $143.8 million in the fourth quarter of the prior year. Foreign currency negatively impacted the fourth quarter net sales by approximately $0.2 million. Revenues from our strategic products were up 6% when compared to the prior year.

 
External net sales by market sector
    Three Months Ended December 31,
      Constant
Reported Currency
(USD in millions) 2011 2010 Growth Growth
 
Spine products
Implants and Biologics $ 36.2 $ 36.3 0 % 0 %
Stimulation   42.4   42.4 0 % 0 %
Total Spine products 78.6 78.7 0 % 0 %
 
Orthopedics products 44.5 38.3 16 % 17 %
 
Sports Medicine products 27.5 25.1 10 % 10 %
               
Total Strategic products 150.6 142.1 6 % 6 %
 
Divested products   0.9   1.7 -47 % -47 %
 
Total net sales $ 151.5 $ 143.8 5 % 6 %
 

Note: Some calculations may be impacted by rounding. The Divested products line above includes sales from the divested vascular business of $0.9 million and $1.7 million in the fourth quarter of 2011 and 2010, respectively.

Fourth quarter net sales in the Company's spine market sector were $78.6 million, which was approximately flat with the prior year. These results were driven by strong biologics revenue growth, which was offset by market driven weakness in implants revenue. In addition, stimulation products were flat compared to the prior year but were up sequentially.

Fourth quarter net sales in the Company's orthopedics market sector were $44.5 million for the fourth quarter of 2011, which reflects a 16% increase, 17% on a constant currency basis compared to the prior year. This increase was led by external fixation products and international markets.

Fourth quarter net sales in the Company's sports medicine market sector were $27.5 million, which reflects a 10% increase compared to the prior year. These results were primarily driven by the integration of a billing capability during the first quarter of 2011.

Earnings Performance

Reported net income for the fourth quarter was $12.4 million and net income per diluted share was $0.66, up 49% over $0.44 in the fourth quarter of the prior year. Adjusted net income in the fourth quarter of 2011 was $14.9 million, or $0.80 per diluted share, an increase of 18% compared with $0.68 per diluted share in the fourth quarter of the prior year. Excluded from adjusted net income is the previously disclosed $10.5 million charge associated with resolutions with the U.S. Government and its respective tax benefit.

The following tables reconcile reported net income and net income per diluted share to adjusted net income and adjusted net income per diluted share for the quarters ended December 31, 2011 and 2010, and for the full years ended December 31, 2011 and 2010:

             
Fourth Quarter Adjusted Net Income and Adjusted Net Income per Diluted Share   Q4 2011 Q4 2010 % Change
($000's)   EPS ($000's)   EPS ($000's)   EPS
 
Reported GAAP net income and net income per diluted share $ 12,392 $ 0.66 $ 7,964 $ 0.44 56 % 49 %
 

Specified Items:

Charges related to U.S. Government resolutions

2,456 $ 0.13
Foreign exchange (gain) / loss 54 $ 0.00 (341 ) $ (0.02 )
Divested vascular business 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 $ 14,902 $ 0.80 $ 12,114   $ 0.68 23 % 18 %
 
Shares used to calculate EPS (in thousands) 18,740 17,912

 

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.

 

             
Full Year Adjusted Net Income and Net Income per Diluted Share 2011 2010 Difference
($000's)   EPS ($000's)   EPS ($000's)   EPS
 
 
Reported GAAP net (loss) income and net (loss) income per diluted share $ (1,073 ) $ (0.06 ) $ 44,208 $ 2.47 nm nm
 

Specified Items:

 
Charges related to U.S. Government resolutions 48,456 -
Foreign exchange loss 973 214
Succession and restructuring charges 2,738 -
Gain on interest rate swap - (771 )
Divested vascular business - (8,559 )
Reorganization costs - 2,921
Patent dispute resolution - 1,300
           
Adjusted net income and net income per diluted share $ 51,094   $ 2.75 $ 39,313   $ 2.19 30 % 26 %
 
Shares used to calculate EPS (in thousands) 18,564 17,914

 

Note: Some calculations may be impacted by rounding. The Reported GAAP net (loss) income and net (loss) income per diluted shares used in the calculation for 2011 were 18,219,343. 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.

The following table reconciles operating income to adjusted operating income for the fourth quarters ended December 31, 2011 and 2010:

       
 
Fourth Quarter Adjusted Operating Income Q4 2011 Q4 2010
($000's)   % of Sales ($000's)   % of Sales
 
Reported GAAP operating income $ 16,995 11.2 % $ 16,841 11.7 %
 

Specified Items:

 
Charges related to U.S. Government resolutions 10,463 -
Divested vascular business - 300
Reorganization costs - 3,550
Patent dispute resolution   -   2,000
Adjusted operating income $ 27,458 18.1 % $ 22,691 15.8 %

 

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.

The fourth quarter adjusted operating margin increased 230 basis points compared to the same period of the prior year. The improvement reflects the operational efficiencies and consolidation efforts over the past few years, as well as the rationalization of R&D projects. Furthermore, we also experienced lower legal spending as detailed below.

The fourth quarter reported and adjusted results for 2011 included approximately $2.5 million ($1.6 million net of tax) or $0.08 per diluted share of litigation and settlement costs for certain product liability matters related to our Sports Medicine business unit. In addition, the fourth quarter for 2011 included approximately $0.5 million ($0.3 million net of tax) or $0.02 per diluted share of legal expenses associated with the Department of Justice (DOJ) investigation of our bone growth stimulation business and the Company's Foreign Corrupt Practices Act (FCPA) matter at the Company's former distribution subsidiary in Mexico. The fourth quarter reported and adjusted results for the prior year included $4.1 million ($2.7 million net of tax) or $0.15 per diluted share of legal expenses associated with the DOJ and FCPA matters mentioned above.

2012 Outlook

During 2012, the Company expects to generate between $595 million and $605 million in net sales or approximately 3% to 5% growth over reported net sales in 2011. If foreign currency rates hold near current levels, the Company anticipates reported growth to be negatively impacted by 1.0% to 1.5%.

The Company expects GAAP net income for the full year 2012 to be between $2.85 and $2.95 per diluted share and adjusted net income to be between $2.95 to $3.05, which would result in approximately a 7% to 11% increase in net income per diluted share compared to 2011.

 
Orthofix International NV Reported and Adjusted EPS Full Year 2012 Guidance
     
Low High % Change
 
Reported GAAP EPS $ 2.85 $ 2.95

Strategic Initiatives

$ 0.10 $ 0.10
Adjusted EPS $ 2.95 $ 3.05 7%-11%
 

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 2011. 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 38220. 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 38220. 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 diversified, global medical device company focused on developing and delivering innovative repair and regenerative technologies to the spine and orthopedic markets. 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 research and clinical organizations such as the Musculoskeletal Transplant Foundation, the Orthopedic Research and Education Foundation and Texas Scottish Rite Hospital for Children. For more information about Orthofix, please visit http://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.

The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the expected sales of our products, including recently launched products, unanticipated expenditures, the resolution of pending litigation matters (including the government investigation and False Claims Act matters relating to our bone growth stimulation and spinal implant businesses, and the possible violations of the FCPA by our former Mexican orthopedic distribution entity, as well as certain product liability claims against our sports medicine global business unit), 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). Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances, or otherwise.

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 and 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,
2011 2010 2011 2010
 
Net sales $ 151,526 $ 143,796 $ 578,988 $ 564,370
Cost of sales   35,104     32,669     139,186     131,716  
Gross profit   116,422     111,127     439,802     432,654  
 
Operating expenses
Sales and marketing 62,197 60,186 233,609 230,942
General and administrative 19,345 25,218 86,468 88,628
Research and development 5,774 7,077 25,148 30,350
Amortization of intangible assets 1,648 1,505 5,595 5,763
Net gain on sale of vascular operations - 300 - (12,019 )
Charges related to U.S. Government resolutions   10,463     -     56,463     -  
  99,427     94,286     407,283     343,664  
 
Operating income 16,995 16,841 32,519 88,990
 
Other income and expense
Interest expense, net (2,583 ) (2,127 ) (9,463 ) (16,898 )

Loss on refinancing of credit facility

- - - (550 )

Gain on interest rate swap

- - - 1,254
Other (expense) income, net (599 ) 507

(2,352

) (398 )
                       
Income before income taxes 13,813 15,221 20,703 72,398
Income tax expense   (1,421 )   (7,257 )  

(21,777

)   (28,190 )
Net income (loss) $ 12,392   $ 7,964     ($1,073 ) $ 44,208  
 
Net income (loss) per common share - basic $ 0.67 $ 0.45 ($0.06 ) $ 2.51
 
Net income (loss) per common share - diluted $ 0.66 $ 0.44 ($0.06 ) $ 2.47
 
Weighted average number of common 18,436,756 17,710,377 18,219,343 17,601,956
shares outstanding - basic
 
Weighted average number of common
shares outstanding - diluted 18,739,623 17,912,059 18,219,343 17,913,545

 

Note: Share amounts used to calculate basic and diluted net loss per common share for the year ended December 31, 2011 are the same because the effect of including common stock equivalents would be anti-dilutive.
 
ORTHOFIX INTERNATIONAL N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, U.S. Dollars, in thousands)
   
 
December 31, December 31,
2011 2010
 
Assets
Current assets:
Cash and cash equivalents $ 33,207 $ 13,561
Restricted cash 47,105 22,944
Trade accounts receivable, net 146,538 134,184
Inventories, net 91,247 84,589
Deferred income taxes 16,867 17,422
Escrow receivable 41,537 14,937
Prepaid expenses and other current assets   28,089   24,123
Total current assets 404,590 311,760
 
Property, plant and equipment, net 52,124 45,535
Patents and other intangible assets, net 37,515 41,457
Goodwill 179,373 176,497
Deferred taxes and other long term-assets   21,949   28,740
Total assets $ 695,551 $ 603,989
 
 
Liabilities and shareholders' equity
Current liabilities:
Bank borrowings $ 1,318 $ 3,812
Current portion of long-term debt 17,500 7,500
Trade accounts payable 20,105 19,796
Accrued charges related to U.S. Government resolutions 82,500 -
Other current liabilities   53,989   52,418
Total current liabilities 175,412 83,526
 
Long-term debt 191,195 208,695
Deferred income taxes 9,777 8,102
Other long-term liabilities   3,996   2,775
Total liabilities   380,380   303,098
 
Shareholders' equity:
Common shares 1,846 1,772
Additional paid-in capital 214,310 195,402
Retained earnings 97,254 98,327
Accumulated other comprehensive income   1,761   5,390
Total shareholders' equity   315,171   300,891
 
Total liabilities and shareholders' equity $ 695,551 $ 603,989
 
ORTHOFIX INTERNATIONAL N.V.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, U.S. Dollars, in thousands)
   
Year Ended December 31,
2011 2010
 
Cash flows from operating activities:
Net (loss) income ($1,073 ) $ 44,208
Adjustments to reconcile net (loss) income to net cash
provided by operating activities:
Depreciation and amortization 22,776 22,521
Net gain on sale of vascular operations - (12,019 )
Other non-cash adjustments 26,904 20,205
Change in operating assets and liabilities:
Escrow receivable (32,562 ) (2,049 )
Charges related to U.S. Government resolutions 88,463 -
Changes in working capital   (39,727 )   (30,358 )
Net cash provided by operating activities 64,781 42,508
 
Cash flows from investing activities:
Capital expenditures (25,758 ) (26,361 )
Payment made in connection with acquisition (5,250 ) -
Net proceeds from sale of assets, principally vascular operations   -     24,215  
Net cash used in investing activities (31,008 ) (2,146 )
 
Cash flows from financing activities:
Net proceeds from issuance of common shares 20,113 7,854
Repayments of long-term debt (7,500 ) (36,269 )
Payment of refinancing fees (758 ) (4,266 )
Proceeds from (repayments of) bank borrowings, net (2,561 ) 1,723
Change in restricted cash (24,178 ) (11,290 )
Cash payment for purchase of minority interest in subsidiary (517 ) -
Tax benefit on non-qualified stock options   1,737     2,222  
Net cash used in financing activities   (13,664 )   (40,026 )
 
Effect of exchange rate changes on cash   (463 )   (103 )
 
Net increase in cash and cash equivalents 19,646 233
Cash and cash equivalents at the beginning of period   13,561     13,328  
Cash and cash equivalents at the end of period $ 33,207   $ 13,561  
 

Non-GAAP Performance Measures

The tables in this press release present reconciliations of net sales, net (loss) income and net (loss) income per diluted share, operating income and effective tax rate calculated in accordance with generally accepted accounting principles (GAAP) to non-GAAP performance measures, referred to as "Adjusted Constant Currency Net Sales", "Adjusted Net Income and Adjusted Net Income per Diluted Share" and "Adjusted Operating Income" 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". 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 (loss) income and net (loss) 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 effected in the current period at the prevailing rate within the respective jurisdictions.

Adjusted Operating Income Reconciling Items

Adjusted Full Year Earnings Per Share Guidance Reconciling Items

   
Adjusted Consolidated EBITDA
Q4 2011 TTM 12/31/11
($000's) ($000's)
Net Income (Loss) $ 12,392 $ (1,073 )
 
Depreciation and amortization 5,500 22,776
Interest expense 2,373 8,550
Tax expense 1,421 21,777
Share-based compensation 1,290 6,648
Other non-cash items 6,695 9,115
Charges related to U.S. Government resolutions   -   50,000  
 
Adjusted Consolidated EBITDA $ 29,671 $ 117,793  
 

NOTE: Adjusted Consolidated EBITDA is computed pursuant to the definition of "Consolidated EBITDA" contained in the Company's credit agreement, dated August 30, 2010, as amended. The credit agreement was filed as Exhibit 10.1 to Company's current report on Form 8-K filed on August 31, 2010 and the amendment was filed on Form 8-K on May 5, 2011. These documents 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 in 2006, 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 units. The items excluded from Orthofix's non-GAAP measures are also excluded from the profit or loss reported by the Company's business units for the purpose of analyzing their performance.

Material Limitations Associated with the Use of Non-GAAP Measures

The non-GAAP measures used in this press 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.

Orthofix International N.V.
Mark Quick, 214-937-2924
Director of Investor Relations and Business Development
markquick@orthofix.com

Source: Orthofix International N.V.

News Provided by Acquire Media