Orthofix Announces New Product Introductions and Record Preliminary Sales Results for Fourth Quarter and Full Year 2004.HUNTERSVILLE, N.C. -- 2004 sales increase by 41%, to $287 million, in line with Company guidance Orthofix International N.V. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :OFIX) today announced that several new products will be introduced at the upcoming American Academy The American Academy in Berlin is a non-partisan academic institution in Berlin. It was founded in September 1994 by a group of prominent Americans and Germans, among them Richard Holbrooke, Henry Kissinger, Richard von Weizsäcker, Fritz Stern and Otto Graf Lambsdorff and opened in of Orthopedic Surgeons Annual Meeting (AAOS AAOS American Academy of Orthopaedic Surgeons. AAOS American Academy of Orthopaedic Surgery ) scheduled for February 23-25, 2005 in Washington DC. The Contours VPS (1) (Vectors Per Second) The measurement of the speed of a vector or array processor. See vector, vector processor and array processor. (2) (Virtual Private Server) See OS virtualization. (TM), an internal plating system that allows for anatomically correct anatomically correct adj. Representing the body or a body part, especially a sex organ, in a physiologically accurate manner: an anatomically correct drawing. alignment in wrist fractures and the BladeRunner(TM), a device used to rapidly and safely release a constricted con·strict v. con·strict·ed, con·strict·ing, con·stricts v.tr. 1. To make smaller or narrower by binding or squeezing. 2. To squeeze or compress. 3. tendon of the hand will be highlighted. These two new entrants into the orthopedic market, along with the Gotfried PC.C.P Percutaneous percutaneous /per·cu·ta·ne·ous/ (per?ku-ta´ne-us) performed through the skin. per·cu·ta·ne·ous adj. Passed, done, or effected through the unbroken skin. Compression Plating System for hip fractures hip fracture Orthopedic surgery A femoral fracture which affects 1/6 white ♀–US during life Epidemiology 250,000/yr–US Specifics Proximal femur; 90+% femoral neck, intertrochanteric; 5-10% are subtrochanteric Risk factors Tall, thin ♀, and the Orthofix ISKD(R) internal lengthener will be featured and supported with clinical presentations at the Orthofix exhibit booth throughout the AAOS Meeting. In addition to these new product offerings, the Cervical-Stim(R), the first and only 'on-label' bone growth stimulator recently approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for enhancing fusion success in the cervical spine cervical spine Clinical anatomy The region of the vertebral column encompassing C1 through C7 , will be featured alongside the market's most complete line of bone growth stimulators. Breg, Inc., an Orthofix company, will also be introducing a new product, an electronic Pain Therapy Pump for the reduction of post-operative pain. In anticipation of its presence at the AAOS meeting, the Company today announced preliminary sales results for the fourth quarter and fiscal year ended December 31, 2004. These preliminary sales results are subject to adjustment as the Company completes its year-end financial closing process and annual financial audit. Orthofix expects to release its complete fourth quarter and full year 2004 financial results on March 3, 2005. The Company indicated that it expects its fourth quarter and full year 2004 financial results to be in line with guidance provided during its third quarter earnings conference call. Sales for the fourth quarter ended December 31, 2004, were $73.6 million, an increase of 40% over the $52.7 million reported during the same period in 2003. Fourth quarter sales included the incremental Additional or increased growth, bulk, quantity, number, or value; enlarged. Incremental cost is additional or increased cost of an item or service apart from its actual cost. impact of Breg, Inc., which was acquired on December 30, 2003. In addition, the positive impact of foreign currency on sales for the fourth quarter of 2004 was $1.4 million. Sales for the year ended December 31, 2004, were $286.6 million, an increase of 41% over the $203.7 million reported during the same period in 2003. Sales for the year ended December 31, 2004, included the incremental impact of Breg, Inc., which was acquired on December 30, 2003. In addition, the positive impact of foreign currency on sales for the twelve-month period was $6.5 million. The following tables display net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight by business segment, net of inter-company eliminations and by market sector for the three months and year ended December 31, 2004, and 2003. We provide net sales by market sector for information purposes only. We maintain our books and records by business segment.
Net sales by business segment for the periods ended December 31,
(In millions)
Three Months Ended Twelve Months Ended
December 31, December 31,
----------------------- -------------------------
% %
2004 2003 Increase 2004 2003 Increase
------ ------ --------- ------- ------- ---------
Americas Orthofix $33.0 $30.7 7% $126.0 $116.8 8%
Americas Breg $17.7 - - $68.3 - -
International
Orthofix $22.9 $22.0 4% $92.3 $86.9 6%
------ ------ --------- ------- ------- ---------
Total $73.6 $52.7 40% $286.6 $203.7 41%
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Net sales by market sector for the periods ended December 31,
(In millions)
Three Months Ended Twelve Months Ended
December 31, December 31,
----------------------- -------------------------
% %
2004 2003 Increase 2004 2003 Increase
------ ------ --------- ------- ------- ---------
Orthopedic Products
------------------
Spine $21.2 $20.6 3% $81.4 $79.5 2%
Reconstruction 31.3 13.4 134% 120.9 51.2 136%
Trauma 15.8 13.6 16% 62.9 53.7 17%
------ ------ --------- ------- ------- ---------
Total Orthopedic 68.3 47.6 43% 265.2 184.4 44%
Non-Orthopedic 5.3 5.1 4% 21.4 19.3 11%
------ ------ --------- ------- ------- ---------
Total $73.6 $52.7 40% $286.6 $203.7 41%
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Charles W. Federico, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Orthofix, commented, "We concluded 2004 with an excellent fourth quarter reflecting 40% sales growth versus the fourth quarter of 2003. For the full year we reported sales growth of 41%. Sales of trauma products where strong all year, up 17% over the prior year, led by 21% growth of the Physio-Stim, the Company's bone growth stimulator for long-bone non-unions, and 11% growth in external fixation external fixation n. The fixation of a fractured bone by a splint or plastic dressing. external fixation Orthopedics Open reduction, stabilization and use of external fixators to manage fracture bone fragments . Reconstruction products also performed well with the contribution of Breg products and 32% growth in external fixation products for reconstruction. Sales of the A-V A-V abbr. 1. arteriovenous 2. atrioventricular A-V, AV 1. arteriovenous. 2. atrioventricular. A-V Atrioventricular, also 1. Anteversion 2. Aortic valve 3. Impulse products continued to recover in the fourth quarter; however, as has been previously noted, the combination of lower contract pricing, a more competitive environment and inventory balancing in the second quarter by our primary customer in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. resulted in lower A-V Impulse sales in 2004 compared to the prior year. In the spine sector, sales of spinal stimulation products were up 4.4% in the fourth quarter over the same period of the prior year and were up 4.2% for the year, while Orthotrac and EZ Brace sales were both down for the quarter and year due to reimbursement issues." "On December 28, 2004, we announced FDA approval for the Cervical-Stim(R), the first and only 'on-label' bone growth stimulator for use as an adjunct to cervical (upper) spine fusion in 'high risk' patients. We have already begun to market and sell the Cervical-Stim and believe that it will contribute to our revenue growth in 2005," stated Federico. Federico stated further, "Breg performed near to our expectations in 2004 with full year sales up 10% compared to the prior year. Fourth quarter sales growth of 5% was impacted by the delay to 2005 in the introduction of several new products and the lingering effects of weather in the southeast on the first half of the fourth quarter." Orthofix International, N.V., a diversified orthopedic products company, offers a broad line of minimally invasive surgical, as well as non-surgical, products for the spine, reconstruction, and trauma 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 Adj. 1. widely distributed - growing or occurring in many parts of the world; "a cosmopolitan herb"; "cosmopolitan in distribution" cosmopolitan bionomics, environmental science, ecology - the branch of biology concerned with the relations between organisms around the world to orthopedic surgeons and patients - via Orthofix's sales representatives, and via partnerships with other leading orthopedic product companies, such as Medtronic Sofamor Danek, Stryker Howmedica, and Kendall Healthcare. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Orthopedic Research and Education Foundation, the Cleveland Clinic Cleveland Clinic (formally known as the Cleveland Clinic Foundation) is a multispecialty academic medical center located in Cleveland, Ohio, USA. Cleveland Clinic was established in 1921 by four physicians for the purpose of providing patient care, research, and medical Foundation, Innovative Spinal Technologies and National Osteoporosis Institute. For more information about Orthofix, please visit www.orthofix.com. FORWARD-LOOKING STATEMENTS forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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, including the performance of the Cervical-Stim(R) 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 relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the integration of the businesses of Orthofix and Breg, unanticipated expenditures, changing relationship with customers, suppliers and strategic partners, risks relating to the protection of intellectual property, changes to the reimbursement policies of third parties, changes to 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 and the economy and other factors described in the most recent report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and other periodic reports filed by Orthofix with the Securities and Exchange Commission. |
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