IVAX Diagnostics Announces Third Quarter Results, Four FDA Clearances, and Three New Distribution Agreements.Business Editors/Health & Medical Writers MIAMI--(BUSINESS WIRE)--Nov. 8, 2001 IVAX IVAX Industrial Vax (Dec Computer) Diagnostics, Inc. (AMEX AMEX See: American Stock Exchange :IVD (Interactive VideoDisc) See interactive video. ) reported financial results for the third quarter ended September 30, 2001. The Company reported that net revenues for the third quarter were $1,910,000, compared to $3,288,000 from the previous year. The net loss for the third quarter was $865,000 compared to net loss of $131,000 for the third quarter of the previous year. For the nine-month period ending September 30, 2001 and excluding merger-related expenses of $1,262,000 associated with the Company's merger with b2bstores.com that was completed on March 14, 2001, the net loss was $1,122,000 compared to a net loss of $414,000 from the previous year. Giorgio D'Urso, 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. and president of IVAX Diagnostics said, "The results of this quarter have been negatively affected by Sigma Diagnostics, our private label partner and largest customer, ordering no instruments and minimal spare parts during the quarter. In the same quarter of the year 2000, Sigma placed orders totaling $1,785,000. The instrument program remains a priority for Sigma Diagnostics and they expect to resume ordering as their overstock diminishes." In addition, IVAX Diagnostics announced that its wholly-owned subsidiary, Diamedix Corporation, received marketing clearance from the U.S. Food and Drug Administration (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 its Anti-Gliadin IgG, Anti-Gliadin IgA, Anti-Cardiolipin IgG/IgM, and Anti-Cardiolipin IgA immunosimplicity(R) test kits. The two Anti-Gliadin kits are Enzyme Immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. (EIA (Electronic Industries Alliance, Arlington, VA, www.eia.org) A membership organization founded in 1924 as the Radio Manufacturing Association. It sets standards for consumer products and electronic components. ) procedures for the quantitative detection of gliadin gliadin /gli·a·din/ (-din) a protein present in wheat; it contains the toxic factor associated with celiac disease. gli·a·din n. antibodies that can assist physicians in the diagnosis of certain gluten sensitive enteropathies such as celiac disease celiac disease: see sprue. celiac disease or nontropical sprue Digestive disorder in which people cannot tolerate gluten, a protein constituent of wheat, barley, malt, and rye flours. , dermatitis herpetiformis dermatitis her·pet·i·for·mis n. A chronic disease of the skin marked by severe itching and the extensive eruption of vesicles and groups of papules. Also called Duhring's disease. , and atopic dermatitis Atopic Dermatitis Definition Eczema is a general term used to describe a variety of conditions that cause an itchy, inflamed skin rash. Atopic dermatitis, a form of eczema, is a non-contagious disorder characterized by chronically inflamed skin and . The two Anti-Cardiolipin kits assist physicians in assessing the risk of thrombosis in patients with systemic lupus erythematosus Systemic Lupus Erythematosus Definition Systemic lupus erythematosus (also called lupus or SLE) is a disease where a person's immune system attacks and injures the body's own organs and tissues. Almost every system of the body can be affected by SLE. (SLE SLE systemic lupus erythematosus. SLE abbr. systemic lupus erythematosus Systemic lupus erythematosus (SLE) ) or other autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . Autoantibodies directed against phospholipids, and anti-cardiolipin in particular, have been associated with venous thrombosis, arterial thrombosis and spontaneous abortions. These new test kits are designed to be used manually or in conjunction with the MAGO MAGO Muslims Against Global Oppression (R) Plus system manufactured by IVAX Diagnostics' subsidiary, Delta Biologicals, S.r.l., based in Italy. IVAX Diagnostics believes that these new Anti-Gliadin and Anti-Cardiolipin assays represent a significant addition to the menu of autoimmune assays that it already markets. IVAX Diagnostics now currently markets 40 FDA-cleared immunosimplicity(R) test kits, primarily in the areas of autoimmune disease autoimmune disease, any of a number of abnormal conditions caused when the body produces antibodies to its own substances. In rheumatoid arthritis, a group of antibody molecules called collectively RF, or rheumatoid factor, is complexed to the individual's own gamma and infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. assays. This combination of test kits, instrumentation and proprietary software is intended to provide laboratories with an automated "walk-away" system enabling them to test for autoimmune and infectious diseases in an efficient, labor saving manner. IVAX Diagnostics also announced today the signing of three exclusive agreements with companies located in Australia, Mexico and China. Australian Laboratory Services Pty Ltd (ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund. ), based in Homebush, New South Wales “Homebush” redirects here. For the ghost town in Victoria, Australia, see Homebush, Victoria. Homebush is an Inner West suburb of Sydney, in the state of New South Wales, Australia. , Australia will market IVAX Diagnostics' immunosimplicity(R) test kits and MAGO(R) Plus automated immunoassay instrument in Australia and New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. . Raul Alvarez, IVAX Diagnostics' Vice President of International Sales & Marketing, announced that IVAX Diagnostics also signed exclusive agreements with Quimica Valaner S.A. de C.V., based in Mexico City, and Beijing Ai-Di-Fa Medical Equipment Company, based in Beijing City, for the distribution of the Company's products in those two countries. Mr. D'Urso added, "We believe that the fundamental factors for the medium to long term development and growth of IVAX Diagnostics are in place. The Company's product menu has been supplemented with the addition of Cardiolipin IgG and IgM, a best seller in the autoimmunity sector, and the international acceptance of our MAGO(R) Plus System by the establishment of new distributors in our worldwide network. The U.S. placement of MAGO(R) Plus Systems continues to increase and the revenue they provide is expected to improve with the new product additions. Total sales by Diamedix' U.S. direct sales force have increased by 68% over the same quarter last year and we expect this growth to increase. We are continuing to add new sales personnel in the U.S. to expand our direct sales coverage." Phillip Frost, M.D., IVAX Diagnostics' chairman said, "The basic growth strategies linked to company and product acquisitions are moving forward and I am confident these objectives will facilitate IVAX Diagnostics' intent to become a major diagnostic company in the future." About IVAX Diagnostics, Inc. IVAX Diagnostics, Inc., headquartered in Miami, Florida, develops, manufactures and markets proprietary diagnostic reagents, instrumentation and software in the United States and Italy through its three subsidiaries: Diamedix Corporation, Delta Biologicals S.r.l. and ImmunoVision, Inc. IVAX Corporation (AMEX: IVX, LSE LSE - Language Sensitive Editor : IVX.L) owns approximately 70% of IVAX Diagnostics, Inc. Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of 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. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect the business and prospects of IVAX Diagnostics, Inc., including but not limited to the risks that Sigma Diagnostics may not resume ordering instrumentation or related spare parts at anticipated levels or within anticipated time frames; that IVAX Diagnostics, Inc. may not expand, either through internal growth or acquisition; that it may not generate increased revenues in the future; that its new instruments and products may not prove to be commercially successful; that it may not enter into additional distribution agreements; that the MAGO(R) instrument and immunosimplicity(R) test kits may not be successfully introduced in additional markets; that sales of the MAGO(R) instrument and immunosimplicity(R) test kits may not continue to increase in the United States; that expansion into international markets may not prove successful; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in the Company's filings with the Securities and Exchange Commission.
IVAX DIAGNOSTICS, INC.
RESULTS OF OPERATIONS
(Unaudited)
Period Ended September 30, Three months Nine months
(In thousands, except per share data) 2001 2000 2001 2000
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Net revenues $1,910 $3,288 $8,047 $9,928
Cost of sales 989 1,430 3,654 4,399
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Gross profit 921 1,858 4,393 5,529
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Operating expenses:
Selling 794 621 2,299 1,924
General and administrative 842 526 3,514 1,500
Research and development 349 312 958 968
Goodwill amortization 64 64 191 192
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Total operating expenses 2,049 1,523 6,962 4,584
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Income (loss) from operations (1,128) 335 (2,569) 945
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Other income (expense), net 205 (94) 541 (319)
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Income (loss) from continuing
operations before income taxes (923) 241 (2,028) 626
Provision for income taxes (58) 372 356 1,040
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Net income (loss) $ (865)$ (131) $(2,384)$ (414)
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BASIC AND DILUTED (LOSS) PER SHARE: $ (.03)$ (.01) $ (.09)$ (.02)
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BASIC AND DILUTED AVERAGE
SHARES OUTSTANDING: 28,629 20,000 26,293 20,000
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IVAX DIAGNOSTICS, INC.
CONDENSED BALANCE SHEETS
(In thousands)
September 30, December 31,
2001 2000
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(Unaudited)
ASSETS
Current assets $ 31,616 $ 9,630
Property, plant and equipment, net 1,453 1,538
Other assets 7,984 7,945
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Total assets $ 41,053 $ 19,113
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 2,792 $ 3,601
Due to principal shareholder - 7,962
Other long-term liabilities 366 332
Shareholders' equity 37,895 7,218
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Total liabilities and shareholders'
equity $ 41,053 $ 19,113
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