Orthofix International Announces Second Quarter 2007 Sales Growth of 46%.HUNTERSVILLE, N.C. -- 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): * Second quarter sales totaled $123.3 million, up 46% from the second quarter of 2006, including a record $30.1 million from Blackstone Medical * Total spine sales rose 107% from prior year; Blackstone Medical revenues up 36% year-over-year * Orthopedic orthopedic /or·tho·pe·dic/ (-pe´dik) pertaining to the correction of deformities of the musculoskeletal system; pertaining to orthopedics. sales increased 13% year-over-year * Sports medicine sports medicine, branch of medicine concerned with physical fitness and with the treatment and prevention of injuries and other disorders related to sports. Knee, leg, back, and shoulder injuries; stiffness and pain in joints; tendinitis; "tennis elbow"; and sales grew 10% compared with second quarter 2006 * International division sales up 15% year-over-year * Reported net income was $7.2 million, or $0.43 per diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share Orthofix International N.V., (NASDAQ: OFIX) (the Company) announced today that total revenue for the second quarter ended June 30, 2007 was $123.3 million, an increase of 46% over the second quarter of 2006. This included a record $30.1 million from Blackstone Medical, Inc. (Blackstone), which was acquired in September of 2006. Excluding Blackstone's revenue, Orthofix's second quarter sales rose 10% over the prior year. The impact of foreign currency on sales for the second quarter of 2007 was a positive $1.9 million. Reported second quarter earnings totaled $7.2 million, or $0.43 per diluted share. Adjusted net income, excluding specified non-cash items was $0.72 per diluted share. "Orthofix's core business sectors once again demonstrated strong revenue growth. The spine implant implant /im·plant/ (im-plant´) to insert or to graft (tissue, or inert or radioactive material) into intact tissues or a body cavity. and biologic business acquired from Blackstone continued to grow far in excess of the market rate, and we also continued to see improved performance from our orthopedic and sports medicine units reflecting the success of new product introductions and broad-based restructuring initiatives we began last year," said 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. Alan Milinazzo. Non-GAAP Financial Measures The table below presents a reconciliation between net income calculated in accordance with generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting (GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). ) and two non-GAAP financial measures, referred to as "adjusted net income" and "adjusted net income, excluding specified non-cash items," that exclude from net income the items specified in the table. Management believes it is important to provide investors with the same non-GAAP metrics metrics Managed care A popular term for standards by which the quality of a product, service, or outcome of a particular form of Pt management is evaluated. See TQM. which it uses to supplement information regarding the performance and underlying trends of Orthofix's business operations Business operations are those activities involved in the running of a business for the purpose of producing value for the stakeholders. Compare business processes. The outcome of business operations is the harvesting of value from assets , 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. [TABLE OMITTED] Orthofix also announced that for the third quarter of 2007 it expects to generate $120-$125 million of total revenue. Third quarter earnings per diluted share are expected to be $0.45 to $0.50, and adjusted net income, excluding specified non-cash items is expected to be $0.78 to $0.83 per share. The Company reiterated its full-year revenue expectations of $487 to $502 million, as well as its full-year reported earnings estimate of $1.86 to $1.96. Revenue Total second quarter sales in the Company's spine sector grew 107% year-over-year, to $61.5 million. Implant and biologic revenues from Blackstone were $30.1 million, which was an increase of 36% compared with their second quarter sales in 2006, prior to the acquisition by Orthofix. This growth was due primarily to higher sales of implant products, including ICON[TM] minimally-invasive pedicle pedicle /ped·i·cle/ (ped´i-k'l) a footlike, stemlike, or narrow basal part or structure. ped·i·cle n. 1. A constricted portion or stalk. 2. screw systems, Unity[R] Anterior anterior /an·te·ri·or/ (an-ter´e-or) situated at or directed toward the front; opposite of posterior. an·te·ri·or adj. 1. Placed before or in front. 2. Lumbar lumbar /lum·bar/ (lum´bar) pertaining to the loins. lum·bar adj. Of, near, or situated in the part of the back and sides between the lowest ribs and the pelvis. Plating Systems, Pillar pillar, freestanding columnar supporting member. It is a general term, little used as an exact architectural definition except as applied to an upright support in the medieval styles, consisting of an assemblage of juxtaposed shafts and moldings; unlike the column, [TM], Construx[R] and Construx Mini[TM] vertebral ver·te·bral adj. 1. Of, relating to, or of the nature of a vertebra. 2. Having or consisting of vertebrae. 3. Having a spinal column. body replacement devices and Ascent[R] cervical cervical /cer·vi·cal/ (ser´vi-k'l) 1. pertaining to the neck. 2. pertaining to the neck or cervix of any organ or structure. cer·vi·cal adj. fixation fixation: see psychoanalysis. systems. Additionally, revenue from Blackstone's biologic portfolio increased primarily due to higher sales of Trinity[R] bone growth matrix, AlloQuent[R] lumbar allografts allografts (al´ n.pl the transplantation of tissue between genetically nonidentical individuals of the same species. and Origen DBM (DeciBels below 1 Milliwatt) A measurement of power loss in decibels using 1 milliwatt as the reference point. A signal received at 1 milliwatt yields 0 dBm. A signal at .1 milliwatt is a loss of 10 dBm. See deciBel and dBA. [TM] products. Revenue from Orthofix's market-leading spine stimulation devices rose 7% year-over-year on an 11% increase in unit volume. The growth was driven primarily by the continued strength of the Company's Cervical-Stim[R], which is the only FDA-approved stimulator for the cervical spine cervical spine Clinical anatomy The region of the vertebral column encompassing C1 through C7 . Revenue from Orthofix's orthopedic business grew 13% percent, to $28 million, compared with the prior year. The increase was driven by the continued growth of the Company's internal fixation internal fixation n. The stabilization of fractured bony parts by direct fixation to one another with surgical wires, screws, pins, or plates. devices, including the VeroNail[R] and Volar Plate System[TM], and deformity Deformity See also Lameness. Calmady, Sir Richard born without lower legs. [Br. Lit.: Sir Richard Calmady, Walsh Modern, 84] Carey, Philip embittered young man with club foot seeks fulfillment. [Br. Lit. correction devices, including the eight-Plate Guided Growth System[R]. Additionally sales of the Physio-Stim[R] bone growth stimulator for non-union fractures grew 16%. Based on recent above market growth rates Growth Rates The compounded annualized rate of growth of a company's revenues, earnings, dividends, or other figures. Notes: Remember, historically high growth rates don't always mean a high rate of growth looking into the future. for Physio-Stim, the Company estimates it has increased its share of the total long bone stimulation market from approximately 10% previously to approximately 15% currently. The Company's sports medicine sector revenue rose 10% year-over-year, to $21.3 million, primarily due to U.S. sales increases of 8% from its functional knee braces See curly brace. , including its innovative lines of FUSION[R] braces, and 12% from its cold therapy products, including its PolarCare[R] line of pain management devices. Results in Orthofix's international division continued to show improvement, with revenue growth of 15% compared with the second quarter last year, including the positive impact of foreign currency on sales. This was primarily a result of the improvement in the orthopedic business noted above, as well as strong year-over-year revenue growth in the Company's non-core vascular and distributed product sector. Gross Margin The gross margin percentage in the second quarter of 2007 was 73.2%, compared with 75% in the second quarter of 2006. The lower gross margin in 2007 was primarily a result of the non-cash amortization of the step-up in inventory that was part of the purchase accounting associated with the Blackstone acquisition. The step-up in inventory will be fully amortized at the end of the third quarter this year. Additionally, the gross margin was impacted by changes in the relative values of currencies. The weaker U.S. dollar results in higher production costs, primarily for the Company's orthopedic devices manufactured in Europe and ultimately sold in U.S. dollars. Operating Expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. Sales and marketing (S&M) expenses as a percent of revenue increased by 70 basis points year-over-year, to 38.4%, while general and administrative (G&A) expenses decreased by 70 basis points, to 13.6% of sales. The increase in the S&M ratio is primarily due to the acquisition of Blackstone, which carries a higher S&M ratio than the legacy Orthofix businesses. The decrease in the G&A ratio reflects the leverage obtained from spreading these costs over a larger revenue base after the Blackstone acquisition. Additionally, the Company recognized non-cash stock compensation expense of approximately $2.5 million ($1.7 million net of tax, or $0.10 per share). This compares with $1.8 million ($1.2 million net of tax, or $0.07 per share) in the second quarter of 2006. Research and development expenses in the second quarter increased by 170 basis points year-over-year, to 4.9% of total sales, primarily due to the Blackstone acquisition. Other Income and Expenses Orthofix reported second quarter net interest expense of $5.9 million, compared with interest income of approximately $255,000 in 2006. The year-over-year increase was mainly a result of debt incurred in connection with the Blackstone acquisition. Taxes The tax rate in the second quarter of 2007 was approximately 29%, which was in line with the Company's full-year guidance of 28%-30%. Conference Call Orthofix will host a conference call today at 11:00 AM Eastern Time to discuss the Company's financial results for the second quarter of 2007. 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 11241147. 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 11241147. About Orthofix Orthofix International, N.V., a global diversified orthopedic products company, offers 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 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 its subsidiaries, including BREG, Inc. and Blackstone Medical, Inc., and via partnerships with other leading orthopedic product companies including Kendall Healthcare. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Orthopedic Research and Education Foundation, Rutgers University Rutgers University, main campus at New Brunswick, N.J.; land-grant and state supported; coeducational except for Douglass College; chartered 1766 as Queen's College, opened 1771. Campuses and Facilities Rutgers maintains three campuses. , 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, and National Osteoporosis osteoporosis (ŏs'tēō'pərō`sĭs), disorder in which the normal replenishment of old bone tissue is severely disrupted, resulting in weakened bones and increased risk of fracture; osteopenia 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 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 relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the expected sales of its products, including recently launched products and those sold by recently acquired subsidiaries, unanticipated expenditures, changing relationship with customers, suppliers and strategic partners, risks relating to the protection of intellectual property, changes to the reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. 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 and the economy, corporate development and market development activities, unexpected costs or operating unit operating unit A type of operating company that engages in transactions with outsiders and that is owned by another business. For example, in 1995 the stockholders of Capital Cities/ABC approved a $19 billion merger with the Walt Disney Company, whereupon performance related to recent acquisitions and other factors described in our annual 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 the Company with the Securities and Exchange Commission. [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] Regulation G Supplemental Information Schedule The information in this schedule is set up in three sections intended to address different aspects of Regulation G. Section 1 includes a table that reconciles the Company's 2007 estimates for net income per share calculated in accordance with generally accepted accounting principles (GAAP) and a non-GAAP financial measure, referred to as "adjusted net income, excluding additional specified non-cash items", that is also expressed as a per share amount and excludes from net income the items specified in the table. Section 2 contains explanations of each of the specified items and additional non-cash specified items listed in the Reconciliation of Non-GAAP Performance Measures for the 2nd quarters of 2007 and 2006 that is included in the body of this release, and the Reconciliation of a Non-GAAP Guidance Measure included below in Section 1 of this supplemental schedule. Section 3 provides detailed disclosures indicating the reasons management believes our non-GAAP measures are useful. Section 1 [TABLE OMITTED] Section 2 Description of 2nd quarter Specified Items and Specified Non-Cash Items Specified Items * Benefit from adoption of tax provision in Italy - In 2006, the Company elected to adopt a new tax provision in Italy allowing the Company to revalue its trademarks for tax purposes only. Specified Non-Cash Items * Non-cash BREG amortization - non-cash amortization of purchase accounting items associated with the acquisition of BREG, net of tax. * Non-cash Blackstone amortization - non-cash amortization of purchase accounting items associated with the acquisition of Blackstone Medical, net of tax. This includes amortization related to intangible assets Intangible Asset An asset that is not physical in nature. Notes: Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible assets. as well as the step-up of inventory being amortized as a part of the cost of goods sold Cost of goods sold The total cost of buying raw materials, and paying for all the factors that go into producing finished goods. cost of goods sold . * Adoption of FAS 123R - equity compensation expense resulting from the adoption of FAS 123R. Section 3 Management use of, and economic substance behind, Non-GAAP Financial Measures Management uses the two non-GAAP measures, referred to as "adjusted net income" and "adjusted net income, excluding additional specified non-cash items," 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 segments. The items excluded from Orthofix's non-GAAP measures are also excluded from the profit or loss reported by the Company's business segments for the purpose of analyzing their performance. Material Limitations Associated with the Use of Non-GAAP Measures Non-GAAP adjusted net income and the per share amounts based on this measure, as well as non-GAAP adjusted net income, excluding additional specified non-cash items, and the per share amounts based on this measure, may have limitations as analytical tools, and these non-GAAP measures should not be considered in isolation or as a replacement for GAAP financial measures. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost to the Company and can have a material effect on cash flows. For example, the amortization of purchased intangible assets does not directly affect Orthofix's cash flows, however, it does represent the reduction in value of those assets over time, and the expense associated with this reduction in value is not included in the Company's non-GAAP measures. Similarly, stock 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 financial 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 numbers reflect the underlying operating results of the Company's businesses, excluding non-operating or unusual items, which management believes are important measures of the Company's overall performance. The Company provides detailed reconciliations of each non-GAAP financial measure to its most directly comparable GAAP measure, and encourages investors to review these reconciliations. 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 financial 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 financial measures. |
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