-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Dnxv/JiFyMHhit13vcQBoY6Do1aOCfSY6u9GZeSgNFPVHq7WsG7fZvu6Pf51N3KZ iHfA9XLcicappbTBU/hYgA== 0000947871-05-000483.txt : 20050217 0000947871-05-000483.hdr.sgml : 20050217 20050217152709 ACCESSION NUMBER: 0000947871-05-000483 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050217 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050217 DATE AS OF CHANGE: 20050217 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ORTHOFIX INTERNATIONAL N V CENTRAL INDEX KEY: 0000884624 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19961 FILM NUMBER: 05624030 BUSINESS ADDRESS: STREET 1: 7 ABRAHAM DE VEERSTRAAT STREET 2: CURACAO CITY: NETHERLANDS ANTILLES STATE: P8 ZIP: 00000 8-K 1 f8k_021505.txt CURRENT REPORT UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 17, 2005 ORTHOFIX INTERNATIONAL N.V. (Exact name of registrant as specified in charter)
NETHERLANDS ANTILLES 0-19961 N/A (State or other (Commission File Number) (I.R.S. Employer jurisdiction of incorporation) Identification No.) 7 Abraham de Veerstraat, Curacao, Netherlands Antilles N/A (Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: 011-59-99-465-8525 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 1 Item 2.02. Results of Operations and Financial Condition --------------------------------------------- On February 17, 2005, Orthofix International N.V. issued a press release announcing, among other things, its preliminary sales results for the fourth quarter and full fiscal year ended December 31, 2004. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein. Item 9.01. Financial Statements and Exhibits --------------------------------- (c) Exhibits 99.1 Press release of Orthofix International N.V. dated February 17, 2005 2 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ORTHOFIX INTERNATIONAL N.V. By: /s/ Thomas Hein ------------------------------------- Name: Thomas Hein Title: Chief Financial Officer Date: February 17, 2005 3 EX-99.1 2 ex99-1_021505.txt PRESS RELEASE Exhibit 99.1 [ORTHOFIX LOGO] For Further Information: ------------------------ Charles W. Federico Thomas Hein Group President & CEO CFO Orthofix International N.V. Orthofix International N.V. 704.948.2600 704.948.2600 Orthofix Announces New Product Introductions and Record Preliminary Sales Results for Fourth Quarter and Full Year 2004 2004 sales increase by 41%, to $287 million, in line with Company guidance HUNTERSVILLE, N.C., February 17, 2005 - Orthofix International N.V. (NASDAQ:OFIX) today announced that several new products will be introduced at the upcoming American Academy of Orthopedic Surgeons Annual Meeting (AAOS) scheduled for February 23-25, 2005 in Washington DC. The Contours VPS(TM), an internal plating system that allows for anatomically correct alignment in wrist fractures and the BladeRunner(TM), a device used to rapidly and safely release a constricted tendon of the hand will be highlighted. These two new entrants into the orthopedic market, along with the Gotfried PC.C.P Percutaneous Compression Plating System for hip fractures 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 for enhancing fusion success in the cervical spine, 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 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 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 December 31, Twelve Months Ended 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% ============ ============= ============== ============ ============ ==============
Net sales by market sector for the periods ended December 31, (In millions)
Three Months Ended December 31, Twelve Months Ended 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% ============ ============= ============== ============ ============ ==============
Charles W. Federico, President and CEO 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. 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 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 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, 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 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 Foundation, Innovative Spinal Technologies and 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, 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 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 and other periodic reports filed by Orthofix with the Securities and Exchange Commission. -----END PRIVACY-ENHANCED MESSAGE-----