Business Services Industry

IVAX Diagnostics Announces Second Quarter Results, Venezuelan Distribution Agreement, and New Product Submissions

Business Wire, August 6, 2001

Business Editors/Health & Medical Writers

MIAMI--(BUSINESS WIRE)--Aug. 6, 2001

IVAX Diagnostics, Inc. (AMEX:IVD) reported financial results for the second quarter ended June 30, 2001. The company reported that net revenues for the second quarter increased to $2,850,000, compared to $2,718,000 from the previous year. Earnings for the second quarter improved to a net loss of $199,000 compared to a net loss of $525,000 for the second quarter of the previous year. For the six month period ending June 30, 2001, the net loss was $1,519,000 compared to a net loss of $283,000 from the previous year; however, the current six month period includes $1,262,000 in merger-related expenses associated with the company's merger with b2bstores.com that was completed on March 14, 2001.

Phillip Frost, M.D., IVAX Diagnostics' chairman said, "I am pleased to see that the operating results improved for the second quarter over the results from the same period a year ago." Dr. Frost further added, "We believe we are building a foundation for a strong integrated diagnostics company that can show continued growth from acquisitions as well as internal activities." Giorgio D'Urso, CEO and president of IVAX Diagnostics said, "We signed a distribution agreement for Venezuela with Labmedics, C.A. of Valencia, Venezuela and expect to announce additional distribution agreements as we build our international network."

IVAX Diagnostics also announced that its wholly-owned subsidiary, Diamedix Corporation in Miami, Florida, has successfully completed the development and clinical testing of three (3) new immunosimplicity(R) test kits to be used either manually or marketed in conjunction with its MAGO(R) Plus automated immunoassay instrument. The three test kits are: Anti-Cardiolipin Screen, Anti-Cardiolipin IgG/IgM, and Anti-Cardiolipin IgA. These three Anti-Cardiolipin kits assist physicians in assessing the risk of thrombosis in patients with systemic lupus erythematosus (SLE) or other autoimmune diseases. Autoantibodies directed against phospholipids and anti-cardiolipin, in particular, have been associated with venous thrombosis, arterial thrombosis and spontaneous abortions. The term "anti-phospholipid syndrome" is often used to describe these conditions.

Diamedix Corporation has filed 510(k) pre-market notification submissions to the U.S. Food and Drug Administration (FDA) for market clearance of these three test kits for manual use or use in conjunction with the MAGO(R) Plus system that is manufactured by Delta Biologicals, S.r.l., IVAX Diagnostics' subsidiary in Italy. Upon receipt of marketing clearance letters from the FDA, IVAX Diagnostics will begin marketing the tests worldwide. IVAX Diagnostics believes that these new Anti-Cardiolipin assays represent a significant portion of the market for autoimmune testing. IVAX Diagnostics already markets 35 other FDA-cleared immunosimplicity(R) test kits, primarily in the areas of autoimmune disease and infectious disease 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, laborsaving manner.

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) 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 provisions of the Private Securities Litigation Reform Act 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 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 be approved by the FDA or may not prove to be commercially successful; that it may not enter into additional distribution agreements; that the MAGO(R) instrument may not be successfully introduced in additional markets; 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 Annual Report on Form 10K and other filings with the Securities and Exchange Commission.


                        IVAX DIAGNOSTICS, INC.
                         RESULTS OF OPERATIONS

Period Ended June 30,
(In thousands, except per share data)
                                     Three months       Six months
                                     2001     2000     2001    2000
                                   -------- -------   ------- ------

Net revenues                     $  2,850 $  2,718 $  6,137 $  6,640
Cost of sales                       1,264    1,298    2,665    2,970
                                 -------- -------- -------- --------
    Gross profit                    1,586    1,420    3,472    3,670
                                 -------- -------- -------- --------

Operating expenses:
    Selling                           738      651    1,505    1,302
    General and administrative        819      578    2,672      975
    Research and development          328      350      609      656
    Goodwill amortization              63       64      127      128
                                 -------- -------- -------- --------
    Total operating expenses        1,948    1,643    4,913    3,061
                                 -------- -------- -------- --------

    Income (loss) from operations    (362)    (223)  (1,441)     609

Other income (expense), net           288     (115)     336     (224)
                                 -------- -------- -------- --------

    Income (loss) from continuing
     operations before income taxes   (74)    (338)  (1,105)     385

Provision for income taxes            125      187      414      668
                                  -------- -------- -------- --------

Net income (loss)                $   (199) $  (525) $(1,519) $  (283)
                                  ======== ======== ======== ========


BASIC AND DILUTED (LOSS) PER
  SHARE:                         $   (.01) $  (.03) $  (.05) $  (.01)
                                  ======== ======== ======== ========

BASIC AND DILUTED AVERAGE
    SHARES OUTSTANDING:            28,622    20,000  28,622   20,000
                                  ======== ======== ======== ========


                        IVAX DIAGNOSTICS, INC.
                       CONDENSED BALANCE SHEETS
                            (In thousands)

                                         June 30,   December 31,
                                           2001        2000
                                        ----------  ----------
ASSETS


Current assets                          $  31,043   $   9,177
Property, plant and equipment, net          1,488       1,538
Other assets                                8,550       7,945
                                        ----------  ----------
       Total assets                     $  41,081   $  18,660
                                        ==========  ==========

LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities                     $   2,522   $   3,148
Due to principal shareholder                    -       7,962
Other long-term liabilities                   327         332
Shareholders' equity                       38,232       7,218
                                        ----------  ----------
       Total liabilities and
        shareholders' equity            $  41,081   $  18,660
                                        ==========  ==========
COPYRIGHT 2001 Business Wire
COPYRIGHT 2001 Gale Group

 

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