-----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, AX1NZIkSnx2BiOfEuFxf0SGR2E5FGrYkHhzBZoxkUOeXhwHihr0pzT7Jyid/fXQI LUYQ9fin1qF0pc29NGbg3Q== 0001116502-02-000259.txt : 20020414 0001116502-02-000259.hdr.sgml : 20020414 ACCESSION NUMBER: 0001116502-02-000259 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020213 ITEM INFORMATION: Other events FILED AS OF DATE: 20020228 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IVAX CORP /DE CENTRAL INDEX KEY: 0000772197 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 161003559 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09623 FILM NUMBER: 02563220 BUSINESS ADDRESS: STREET 1: 4400 BISCAYNE BLVD CITY: MIAMI STATE: FL ZIP: 33137 BUSINESS PHONE: 3055756000 MAIL ADDRESS: STREET 1: 4400 BISCAYNE BOULEVARD CITY: MIAMI STATE: FL ZIP: 33137 FORMER COMPANY: FORMER CONFORMED NAME: IVAX CORP DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: IVACO INDUSTRIES INC DATE OF NAME CHANGE: 19871213 FORMER COMPANY: FORMER CONFORMED NAME: INLAND VACUUM INDUSTRIES INC DATE OF NAME CHANGE: 19870611 8-K 1 ivax-8k.txt CURRENT REPORT 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 13, 2002 Commission File Number 1-09623 IVAX CORPORATION FLORIDA 16-1003559 - ------------------------------- --------------------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 4400 BISCAYNE BOULEVARD, MIAMI, FLORIDA 33137 ------------------------------------------------------------------ (Address of principal executive offices) (Zip Code) (305) 575-6000 -------------- (Registrant's telephone number, including area code) ITEM 5 - OTHER EVENTS AND REGULATION FD DISCLOSURE On February 13, 2002, IVAX Corporation issued a press release containing certain financial information with respect to results of operations for the year ended December 31, 2001. Signatures 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 thereunto duly authorized. IVAX CORPORATION Date: February 28, 2002 By: /s/Thomas E. Beier -------------------------------- Thomas E. Beier Senior Vice President-Finance Chief Financial Officer EXHIBIT INDEX Exhibit 99.1 Press Release issued February 13, 2002. EX-99.1 3 press-release.txt PRESS RELEASE EXHIBIT 99.1 [GRAPHIC OMITTED] [GRAPHIC OMITTED] IVAX ACHIEVES RECORD EARNINGS IN 2001 FY2001 EPS Up 86% To $1.19 Per Share - Net Revenue Up 53% To $1.2 Billion MIAMI - February 13, 2002 - IVAX Corporation (AMEX: IVX, LSE: IVX.L) today reported an 86% increase in net income to $243 million, or $1.19 per share, for the year ended December 31, 2001 from net income of $131 million, or $.64 per share, reported a year ago. Net income for the fourth quarter of 2001 was $53.8 million, or $.27 per share, versus net income of $49.7 million, or $.24 per share, for the same quarter of last year. Net revenue for 2001 increased by 53% to $1.2 billion compared to net revenue of $793 million in 2000. Fourth quarter net revenue rose by 36% to $330 million compared to net revenue of $243 million in the fourth quarter of last year. "Our continued growth during the past year underscores IVAX' strategy of product and geographic diversification that provides multiple revenue sources and income streams. Revenue gains in 2001 were driven by strong worldwide sales of the company's brand and brand equivalent (generic) pharmaceutical products, including U.S. sales of generic paclitaxel and global sales of the company's respiratory products, as well as contributions from acquisitions made over the past year. On a geographic basis, net revenue for the year increased 74% in North America, 10% in Europe and 253% in Latin America over the prior year. International sales were approximately 54% of our net revenue for the year; Argentina represented less than 2.3% of our net revenue. Looking ahead, we anticipate that our branded drug business will grow rapidly upon commercialization of new drugs in our proprietary pipeline while our brand equivalent business will also benefit from a strong pipeline and greater demand due to demographic and market factors. Furthermore, we will continue to make strategic acquisitions of companies, products and technologies as opportunities present themselves," said Phillip Frost, M.D., chairman and chief executive officer of IVAX Corporation. Neil Flanzraich, vice chairman and president of IVAX Corporation said, "This was another successful year for IVAX. Our gross profit for 2001 rose 64% to $630 million while our gross margin improved to 52% compared to 48% a year ago. Our substantial growth in income was achieved despite a 32% increase in research and development spending, which totaled $86 million for the year." Mr. Flanzraich added that "IVAX' worldwide respiratory product sales grew substantially in 2001 compared to $140 million in 2000." He also reiterated that "IVAX' generic paclitaxel product, ONXOL(TM), is on the market to stay. It is the dominant generic paclitaxel product in the U.S. with approximately 95% share of the generic segment and about 40% share of the entire U.S. paclitaxel market. The future of ONXOL was secured last month following our successful invalidation of the American BioScience, Inc. patent claims and the subsequent delisting of this patent from the FDA's Orange Book, which then enabled the FDA to renew approval of our ANDAs without any interruption in the marketing of our product." Mr. Flanzraich summarized IVAX' achievements over the past year, "We continued to develop key drugs in our proprietary and brand equivalent pipelines. In advanced stages of clinical trials are our oral formulation of paclitaxel for lung, breast and stomach cancer. The immunotoxin, TP-38, for brain cancer continues to show great promise. Various asthma drugs in our patented inhalers and drugs to treat multiple sclerosis, epilepsy and Parkinson's disease are also in the clinical stages of development as are drugs to treat regional ileitis and colitis. A unique, patented, new drug for hormone replacement therapy appears to have important potential and is also in human trials." "We filed 12 Abbreviated New Drug Applications (ANDAs) and received eight brand equivalent drug approvals and one tentative approval in 2001. So far in 2002, we have filed four ANDAs and received three generic approvals giving us a current pipeline of 38 ANDAs and three tentative approvals pending with the FDA," Mr. Flanzraich added. "We also completed strategic acquisitions of pharmaceutical companies in Mexico and Chile, and two currently marketed branded respiratory products for the U.S. market. To market these and other proprietary products, we are increasing our IVAX Laboratories sales force," said Mr. Flanzraich. IVAX continues to repurchase its shares. More than 8.6 million of the 12.5 million shares authorized under the current repurchase program have been repurchased at prices ranging from $17.74 to $35.05 per share. Since February 1998, IVAX has repurchased more than 49.9 million of its shares. At January 31, 2002, the company had approximately 196.4 million shares outstanding. IVAX Corporation, headquartered in Miami, Florida, is engaged in the research, development, manufacturing, and marketing of branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and international markets. Copies of this and other news releases may be obtained free of charge from IVAX' web site at www.ivax.com. Shareholders and prospective investors can register to automatically receive the company's press releases via email at www.ivax.com/ComNewsv2.htm. This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, statements relating to goals, plans and projections regarding the company's financial position, results of operations, market position, product development and business strategy. These statements involve risks and uncertainties that cannot be predicted or quantified and, consequentially, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the uncertainty that the impact of competitive products and prices may be greater than anticipated, that political and economic instability in some countries in which we conduct our business, particularly Argentina and other Latin American countries, may adversely affect the revenue our foreign operations generate, that IVAX has in the past and may in the future experience difficulties in obtaining raw materials necessary for the production of IVAX' products, particularly paclitaxel, on commercially reasonable terms or at all, that the recently approved paclitaxel products and any subsequently approved paclitaxel products may diminish the growth prospects and demand for IVAX' paclitaxel, that recent regulatory and legal resolutions regarding IVAX' paclitaxel product may be appealed or reversed and could result in a suspension of IVAX' ability to market ONXOL, that the company may not be able to purchase additional companies, products or technologies or increase its sales force, that benefits anticipated from acquisitions will not occur, that benefits anticipated from tax structures will not occur, that clinical trials and studies for products and compounds under development may not be commenced, may take longer than anticipated, may fail, may not achieve the expected results or effectiveness and may not generate the data that would support the approval or marketing of these products for the indications being stated or for other indications, and that the compounds and products in IVAX' research pipeline will not be successfully developed, will not receive regulatory approval or will not be successfully commercialized. In addition to the risk factors set forth above, IVAX' forward looking statements may also be adversely affected by general market factors, competitive product development, product availability, current and future branded and generic competition for the company's products, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, trade buying patterns, exchange rate fluctuations, patent positions and the timing and outcome of legal proceedings, among other things. For further details and discussion of these and other risks and uncertainties, see IVAX' Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. IVAX undertakes no obligation to publicly update any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Paclitaxel is the generic name of the cancer drug Taxol(R), a registered trademark of Bristol-Myers Squibb Company. CONTACTS: Thomas E. Beier Senior Vice President, Finance & Chief Financial Officer 305.575.6563 or Howard A. Goldman Director/Investor Relations & Corporate Communications 305.575.6043 www.ivax.com IVAX Corporation and Subsidiaries Condensed Consolidated Statements of Operations
Three Months Twelve Months Period Ended December 31, 2001 (1) 2000 2001 (1) 2000 (In thousands, except per share data) -------- ---- -------- ---- Net revenues $ 329,856 $ 242,754 $1,213,560 $ 793,405 Cost of sales 166,397 125,134 583,588 409,903 ---------- ---------- ---------- ---------- Gross profit 163,459 117,620 629,972 383,502 ---------- ---------- ---------- ---------- Selling, general and administrative 70,796 52,084 254,106 176,932 Research and development 20,988 15,705 86,198 65,331 Amortization 6,186 2,634 19,412 9,042 Restructuring costs (accrual reversal) 1,270 (496) 2,367 (4,535) ---------- ---------- ---------- ---------- Total operating expenses 99,240 69,927 362,083 246,770 ---------- ---------- ---------- ---------- Income from operations 64,219 47,693 267,889 136,732 Total other income (expense), net (634) 4,324 17,793 16,859 ---------- ---------- ---------- ---------- Income from continuing operations before income taxes and minority interest 63,585 52,017 285,682 153,591 Provision for income taxes 9,979 2,240 49,883 13,214 ---------- ---------- ---------- ---------- Income from continuing operations before minority interest 53,606 49,777 235,799 140,377 Minority interest 201 (74) 344 (608) ---------- ---------- ---------- ---------- Income from continuing operations 53,807 49,703 236,143 139,769 Extraordinary item - gain (loss) on extinguishment of debt, net of tax -- -- 7,120 (2,254) Cumulative effect of a change in accounting principle, net of taxes -- -- -- (6,471) ---------- ---------- ---------- ---------- NET INCOME $ 53,807 $ 49,703 $ 243,263 $ 131,044 ========== ========== ========== ========== BASIC EARNINGS PER SHARE: Income from continuing operations $ 0.27 $ 0.25 $ 1.18 $ 0.71 Extraordinary item, net of tax -- -- 0.04 (0.01) Cumulative effect, net of tax -- -- -- (0.03) ---------- ---------- ---------- ---------- Net Income $ 0.27 $ 0.25 $ 1.22 $ 0.67 ========== ========== ========== ========== DILUTED EARNINGS PER SHARE: Income from continuing operations $ 0.27 $ 0.24 $ 1.15 $ 0.68 Extraordinary item, net of tax -- -- 0.04 (0.01) Cumulative effect, net of tax -- -- -- (0.03) ---------- ---------- ---------- ---------- Net Income $ 0.27 $ 0.24 $ 1.19 $ 0.64 ========== ========== ========== ========== AVERAGE SHARES OUTSTANDING: Basic 197,322 199,108 199,099 196,276 ========== ========== ========== ========== Diluted 201,635 207,011 204,639 204,059 ========== ========== ========== ==========
(1) Results of operations includes the results of Fustery, Netpharma, and Lab Chile subsequent to their acquisitions. IVAX Corporation and Subsidiaries Condensed Consolidated Balance Sheets Condensed Balance Sheets December 31, December 31, (In thousands) 2001 2000 ---- ---- Assets - ------ Cash & cash equivalents $ 178,263 $ 174,794 Marketable securities 154,842 76,734 Other current assets 618,858 407,586 Property, plant and equipment, net 356,303 250,852 Other assets 788,986 158,220 ---------- ---------- Total assets $2,097,252 $1,068,186 ========== ========== Liabilities and Shareholders' Equity - ------------------------------------ Current portion of long-term debt $ 52,199 $ 934 Other current liabilities 349,160 219,690 Long-term debt 913,486 253,755 Other long-term liabilities 57,791 23,472 Minority interest 14,712 1,712 Temporary equity - put options -- 84,503 Shareholders' equity 709,904 484,120 ---------- ---------- Total liabilities and shareholders' equity $2,097,252 $1,068,186 ========== ========== IVAX Corporation and Subsidiaries Business Segment Information
Revenues by Region (In Thousands) Three months Twelve months Period Ended December 31, 2001 2000 2001 2000 ---- ---- ---- ---- North America External sales $ 141,678 $ 106,908 $ 582,471 $ 320,244 Intersegment sales 1,617 -- 2,838 422 Other revenues 8,232 292 9,652 20,573 ----------- ----------- ----------- ----------- Net revenues - North America 151,527 107,200 594,961 341,239 ----------- ----------- ----------- ----------- Europe External sales 81,306 80,019 303,150 285,239 Intersegment sales 25,563 -- 60,686 22,387 Other revenues 11,818 26,504 55,269 71,996 ----------- ----------- ----------- ----------- Net revenues - Europe 118,687 106,523 419,105 379,622 ----------- ----------- ----------- ----------- Latin America External sales 78,899 24,768 222,444 62,299 Other revenues 185 (52) 1,741 1,136 ----------- ----------- ----------- ----------- Net revenues - Latin America 79,084 24,716 224,185 63,435 ----------- ----------- ----------- ----------- Corporate & other External sales 8,627 4,194 35,973 31,888 Intersegment sales (27,180) -- (63,524) (22,809) Other revenues (889) 121 2,860 30 ----------- ----------- ----------- ----------- Net revenues - Corporate & other (19,442) 4,315 (24,691) 9,109 ----------- ----------- ----------- ----------- Net revenues $ 329,856 $ 242,754 $ 1,213,560 $ 793,405 =========== =========== =========== ===========
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