Orthofix International N.V.
05/06/09

Orthofix International Announces 1st Quarter 2009 Results And Additional Debt Payment Ahead of Scheduled Maturity

BOSTON, May 06, 2009 (BUSINESS WIRE) -- Orthofix International N.V. (NASDAQ:OFIX) (the Company) today announced its results for the first quarter ended March 31, 2009. As the Company previously announced, total revenue was $129.0 million, which was an increase of 1% over the first quarter of 2008. Excluding the unfavorable $5.1 million impact of foreign currency rates on first quarter sales, revenue increased 5% on a constant currency basis.

Reported first quarter net income totaled $2.9 million, or $0.17 per share. This compared with $3.6 million, or $0.21 per share in the first quarter of the prior year. The year-over-year decrease is due primarily to higher interest expense and the negative impact of non-cash foreign currency adjustments on earnings in 2009.

Excluding certain items summarized in the table below, first quarter adjusted net income was $6.1 million, or $0.35 per share.

"We were pleased to start 2009 with a solid quarter, including constant currency revenue growth of five percent, higher gross margins than a year ago, and results at our spinal implants division that were ahead of our expectations," said President and CEO Alan Milinazzo. "Additionally, our improved cash flow allowed us to make a total of $15 million in debt payments ahead of their scheduled maturities so far this year, including another $3 million announced today."

Non-GAAP Performance Measures

The table below presents a reconciliation of first quarter net income calculated in accordance with generally accepted accounting principles (GAAP) to a non-GAAP performance measure, referred to as "adjusted net income", that excludes from net income the items specified in the table. Additionally, a reconciliation of first quarter sports medicine revenue calculated in accordance with GAAP to a non-GAAP performance measure, referred to as "adjusted revenue", and a reconciliation between first quarter net income calculated in accordance with GAAP and the non-GAAP measure referred to as "Consolidated EBITDA" are included in the Regulation G Supplemental Information Schedule attached to this release. 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 table below that are excluded from GAAP net income, 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.

                       
First Quarter   Q109     Q108
    ($000's)     EPS     ($000's)     EPS
                       
                       
Reported GAAP net income   $ 2,879       $ 0.17       $ 3,606       $ 0.21  
                       

Specified Items:

                     
                       
Strategic investments   $ 1,876       $ 0.11       $ 3,390       $ 0.20  
Reorganization/consolidation costs   $ 874       $ 0.05         ---         ---  
Costs associated with proxy contest   $ 494       $ 0.03         ---         ---  
Foreign exchange (gain)/loss   $ 110       $ 0.01         ($260 )       ($0.02 )
Unrealized, non-cash gain on interest rate swap     ($160 )       ($0.01 )       ---         ---  
                       
Adjusted net income   $ 6,073       $ 0.35       $ 6,736       $ 0.39  
                       
NOTE: Some calculations may be impacted by rounding                      

Revenue

Total first quarter sales in the Company's spine sector were up 6% year-over-year, to $66.1 million. Spine stimulation revenue increased 12%, to $37.2 million. Implant and biologic revenue was $28.8 million, including international revenue. This was 1% lower than the first quarter of 2008, but increased 2% sequentially from the prior quarter. The sequential growth in implant and biologic revenue was primarily due to a 5% growth in U.S. sales of thoracolumbar and cervical spine implants. As Orthofix announced earlier this week, the Company has initiated the limited market release of Trinity® Evolution, its new adult stem cell-based bone growth allograft, which was developed in collaboration with the Musculoskeletal Transplant Foundation (MTF).

Reported first quarter revenue in the Company's orthopedic business was $29.6 million, which was a decrease of 1%, but represented growth of 10% on a constant currency basis, compared with the prior year. The constant currency revenue growth was driven primarily by increases in international sales of external and internal fixation devices of 7% and 29%, respectively, as well as 26% growth in the U.S. sales of Physio-Stim bone growth stimulation devices. Additionally, biologic sales in the Orthopedic Division more than doubled to approximately $1.3 million.

Sports medicine revenue in the first quarter grew 4% compared with 2008, to $24.2 million. However, after adjusting for the sale of the Company's line of infusion pumps in the first quarter of 2008, revenue increased approximately 8%. First quarter U.S. revenue from the Company's core bracing products and cold therapy devices grew 12% and 8% year-over-year, respectively. The strong growth in the sales of bracing products was a reflection of the recent expansion of certain product lines, including those for the upper extremities and the spine in addition to walker boots. The increase in cold therapy sales was driven by the continued popularity of the Company's Kodiak cold therapydevices.

Gross Margin

The gross profit margin in the first quarter of 2009 was 74.6%, an increase of 130 basis points compared with the first quarter of 2008. The year-over-year improvement is primarily due to an increased mix of revenue from, and higher gross margins at, the Company's spine stimulation, orthopedic and sports medicine businesses.

Operating Expenses

First quarter sales and marketing (S&M) expenses as a percent of revenue increased 130 basis points year-over-year, to 40.5%. The higher S&M ratio was due primarily to an increase in commission expenses reflecting the implementation of sales programs with new distributor partners. This increased investment in sales & marketing has facilitated the development of new customer relationships and increased sales in both the spine stimulation and orthopedic businesses contributing to an improvement in the year-over-year operating profit margin in the Company's spine stimulation and North American orthopedic businesses.

General and administrative (G&A) expenses in the first quarter of 2009 increased by 30 basis points year-over-year, to 17.6% of sales. This included the impact of approximately $1.3 million ($874,000 net of tax, or $0.05 per share) in costs associated with the ongoing reorganization and consolidation plan at the Company's spinal implants business, and approximately $737,000 ($494,00 net of tax, or $0.03 per share) of costs incurred during the first quarter in connection with a proxy contest and special shareholder's meeting.

Research and development (R&D) expenses as a percent of revenue were 7.0% in the first quarter of 2009, compared with 5.0% in the prior year. R&D expenses in the first quarter of 2009 included $2.8 million ($1.9 million net of tax, or $0.11 per share) in costs associated with the Company's previously announced strategic investments. This included the collaboration with the Musculoskeletal Transplant Foundation (MTF) on the development and commercialization of Trinity Evolution, a new adult stem cell-based allograft, and costs associated with the acquisition and development of intellectual property from Intelligent Implant Systems.

Other Income and Expenses

First quarter net interest expense was $6.1 million, compared with interest expense of approximately $5.4 million in the first quarter of the prior year. The increase reflects a higher rate of interest partially offset by a lower outstanding debt balance compared with the prior year.

During the first quarter, the Company also incurred an unrealized, non-cash gain of approximately $239,000 ($160,000 net of tax, or $0.01 per share) which resulted from changes in the fair value of the Company's interest rate swap. Mark-to-market adjustments related to this swap are required to be reported in quarterly earnings through the expiration of the swap in June 2011.

The Company also incurred a foreign exchange loss of approximately $164,000 ($110,000 net of tax, or $0.01 per share) in the first quarter primarily due to unrealized, non-cash foreign currency adjustments resulting from a strengthening of the U.S. dollar against various foreign currencies. A number of Orthofix's foreign subsidiaries have intercompany and trade accounts payable that are denominated in currencies, most notably the U.S. Dollar, other than their local currency, and movements in the relative values of those currencies have and are expected to continue to result in foreign exchange gains and losses.

Taxes

The reported tax rate in the first quarter of 2009 was 33%, which was in line with the Company's full-year guidance of 33%-35%. This was less than the tax rate of 46% in the first quarter of 2008, which included the impact of the sale of the Company's Pain Care assets that increased the consolidated tax rate by approximately 13 percentage points in that quarter.

Cash and Liquidity

Orthofix's Consolidated EBITDA, as calculated in accordance with the Company's amended credit facility, was $21.3 million in the first quarter. At the end of the first quarter the Company's leverage ratio, as defined in its amended credit facility, was 3.5, which was below the 4.0 maximum leverage ratio allowed in the amended credit facility. Cash flow from operations in the first quarter of 2009 was approximately $11.1 million, which compared with cash flow of approximately $900,000 in the prior year. The increase in cash flow was due primarily to improved working capital management. Orthofix continues to have a $45 million unused revolving credit facility, and at the end of the first quarter the Company was in compliance with the financial covenants contained in its amended credit agreement.

The total cash balance of $18.0 million at March 31, 2009 compared with $25.6 million at December 31, 2008. The change in cash balances includes the impact of two previously announced first quarter repayments of debt ahead of scheduled maturities totaling $12 million. The Company also announced that it made an additional $3 million debt prepayment in the 2nd quarter of 2009.

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company's financial results for the first quarter. Interested parties may access the conference call by dialing (866) 626-7622 in the U.S., and (706) 758-3283 outside the U.S., and providing the conference ID 95863375. A replay of the call will be available for one week by dialing (800) 642-1687 in the U.S., and (706) 645-9291 outside the U.S., and entering the conference ID 95863375.

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, orthopedic, 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 Blackstone Medical, Inc., and via partnerships with other leading orthopedic product companies. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Musculoskeletal Transplant Foundation, the Orthopedic Research and Education Foundation, Rutgers University 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, risks relating to the protection of intellectual property, changes to the reimbursement policies of third parties, changes to and interpretation of governmental regulation of medical devices, 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, unexpected difficulties meeting covenants contained in our secured bank credit facility 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).

ORTHOFIX INTERNATIONAL N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, U.S. Dollars, in thousands, except per share and share data)
                 
                 
          Three Months Ended March 31,
          2009     2008
                 
Net sales       $ 128,974       $ 128,032  
Cost of sales         32,806         34,238  
Gross profit         96,168         93,794  
                 
Operating expenses              
Sales and marketing         52,264         50,196  
General and administrative         22,684         22,180  
Research and development         9,087         6,354  
Amortization of intangible assets         1,633         5,043  

Gain on sale of Pain Care® Operations

        0         (1,570 )
            85,668         82,203  
                 
Operating income         10,500         11,591  
                 
Other income (expense)              
Interest income (expense), net         (6,117 )       (5,390 )
Other, net         (323 )       494  
Unrealized non-cash gain on interest rate swap         239         0  
Other income (expense), net         (6,201 )       (4,896 )
Income before income taxes         4,299         6,695  
Income tax expense         (1,420 )       (3,089 )
Net income       $ 2,879       $ 3,606  
                 
Net income per common share - basic       $ 0.17       $ 0.21  
                 
Net income per common share - diluted       $ 0.17       $ 0.21  
                 

Weighted average number of common shares outstanding - basic

        17,103,543         17,087,003  
                 

Weighted average number of common shares outstanding - diluted

        17,121,571         17,261,172  
ORTHOFIX INTERNATIONAL N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands)
                 
                 
          March 31,     December 31,
          2009     2008
                 
Assets              
Current assets:              
Cash and cash equivalents       $