Orthofix International Announces 1st Quarter 2011 Results

Records Charges Related to Government Investigations

LEWISVILLE, Texas--( BUSINESS WIRE )--Orthofix International N.V. (NASDAQ:OFIX) today announced its results for the first quarter ended March 31, 2011.

“Adjusted Net Income and Adjusted Net Income per Diluted Share”

Reported net sales were $139.2 million and reported net loss was $35.8 million, or ($2.00) per diluted share, for the first quarter ended March 31, 2011.

The Company announced a charge in its first quarter results of $46 million related to two pending government investigations. The Company took a charge of $43 million in anticipation of a proposed resolution of criminal and civil matters related to an investigation of its bone growth stimulation business, where it has reached an agreement in principle with the United States Attorney’s Office for the District of Massachusetts. The final settlement is subject to the negotiation and execution of definitive agreements with the United States Attorney’s Office, the United States Department of Justice, and the Office of Inspector General of the United States Department of Health and Human Services.

The Company took a further accounting charge of $3 million to establish a reserve in connection with the potential fines and penalties related to possible violations of the Foreign Corrupt Practices Act (FCPA) that it voluntarily reported to the U.S. Government last June concerning its former Mexican orthopedic distribution entity. The Company’s establishment of this reserve is based on the results of its own internal investigation and an analysis of recent similar FCPA resolutions.

Although neither of these matters has concluded, the Company believes that the costs for which the charges taken during the first quarter are probable of being incurred and paid during 2011. The Company has obtained an amendment to its current credit facility to provide additional capacity under the various restrictive covenants for the payment by the Company of the costs and expenses associated with each of these settlements.

There can be no assurance, however, that the Company will enter into consensual resolution of either of these two matters, or what the final terms of any such resolutions might be.

Reported net sales were $139.2 million in the first quarter of 2011 compared to $138.8 million in the first quarter of the prior year. Foreign currency positively impacted first quarter net sales by approximately $0.5 million. Excluding the impact of exiting the vascular business and anesthesia product line and the revenue from the sports medicine billing business which was acquired in February 2011, adjusted constant currency net sales increased 2% compared to the same period of the prior year.

First quarter net sales in the Company’s spine market sector were up 1% to $72.6 million. Sales growth in our spine market sector was driven by a 14% increase in implants and biologics revenue. The stimulation products used in spine applications decreased 8% primarily as a result of the ongoing industry wide investigation of the bone growth stimulation business and industry reimbursement challenges.

Net sales in the Company’s orthopedics market sector were $40.5 million for the first quarter of 2011, which was a 6% increase and represented growth of 4% on a constant currency basis compared to the prior year. This increase was led by its external fixation platform along with the increased use of Trinity® Evolution™ in orthopedic applications.

First quarter net sales in the Company’s sports medicine market sector were $24.7 million, up 5% compared to $23.6 million in the same period of the prior year. The growth in the Company’s sports medicine market sector was due to improved performances of its bracing product lines. The first quarter of 2011 also includes revenue of $0.5 million from a billing business that was acquired during the first quarter of 2011.

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

Reported net loss for the first quarter was $35.8 million and net loss per diluted share was ($2.00). During the first quarter of 2011, the Company recorded $46.0 million, or ($2.56) per diluted share of settlement charges associated with the bone growth stimulation and FCPA investigations.

Excluding certain items summarized in the table below, adjusted net income in the first quarter of 2011 was $10.8 million, or $0.59 per diluted share, an increase of 26% per diluted share compared with $0.47 per diluted share in the first quarter of the prior year.

The following table reconciles reported net (loss) income and net (loss) income per diluted share to adjusted net income and adjusted net income per diluted share for the first quarters ended March 31, 2011 and 2010:

The following table reconciles operating (loss) income to adjusted operating income for the first quarters ended March 31, 2011 and 2010:

The first quarter reported and adjusted results for 2011 also included approximately $5 million ($3.3 million net of tax) or $0.18 per diluted share of legal costs associated with these two investigations.

The company is reiterating its net sales guidance, which is expected to be between $580-590 million for the full year 2011. Including the Q1 specified items, reported net income for 2011 is expected to be $0.01 - $0.11 per diluted share. Adjusted net income for 2011 is expected to be between $2.60 - $2.70 per diluted share.

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the first quarter 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 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.

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 research and clinical organizations such as the Musculoskeletal Transplant Foundation, the Orthopedic Research and Education Foundation, Texas Scottish Rite Hospital for Children, and the Cleveland Clinical Foundation. For more information about Orthofix, please visit www.orthofix.com .

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 relating to our bone growth stimulation business and the possible violations of the FCPA by our former Mexican orthopedic distribution entity), 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.

The tables in this press release present reconciliations of first quarter net sales, net (loss) income and net (loss) income per diluted share, operating (loss) 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”, “Adjusted Operating Income” and “Adjusted Effective Tax Rate” 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.

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

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

Adjusted Constant Currency Net Sales Reconciling Items

NOTE: Adjusted Consolidated EBITDA is computed pursuant to the definition of “Consolidated EBITDA” contained in the Company’s credit agreement, dated August 30, 2010 and amended as of May 4, 2011. 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 will be filed on Form 8-K on May 5, 2011. These documents can be found at the SEC’s website at www.SEC.gov .

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 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.

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.