Exhibit 99.1
IVAX DIAGNOSTICS REPORTS FIRST QUARTER RESULTS
MIAMI—(BUSINESS WIRE)—May 15, 2007—IVAX Diagnostics, Inc. (AMEX:IVD) reported its financial results for the first quarter of 2007. For the quarter, IVAX Diagnostics recorded net revenues of $4,946,000, an increase of $228,000, or 4.8%, from the first quarter of 2006. Net loss for the first quarter of 2007 was $238,000 compared to net loss of $797,000 in the first quarter of 2006. Net loss for the first quarter of 2006 included a cumulative effect adjustment of $201,000 for a change in accounting principle that was required in 2006 when IVAX Diagnostics adopted SFAS 123(R) to account for stock based compensation.
Giorgio D’Urso, CEO and President of IVAX Diagnostics, said, “We are pleased that we were able to increase sales in the first quarter when compared to the same quarter from last year. We were also able to reduce our losses compared to last year primarily due to an increase in sales in the U.S., an increase in gross profit as a percentage of net revenues to 60.4%, and a decrease in selling expenses. We continue to anticipate submitting our 510(k) application for the PARSEC® System to the FDA during the second quarter of 2007, which, if and when approved, will enable us to market this new automated testing system in the U.S. market. We expect to begin our full-scale commercial launch of the PARSEC® System in the U.S. and international markets upon successful clearance of this application by the FDA. Our expectations remain high for this new automated testing system as well as the upgraded version of our existing Mago® Plus instrument that will be called the Mago® 4. As we have previously announced, this enhanced Mago® instrument is expected to be able to perform both ELISA and IFA techniques simultaneously, perform positive sample identification, and utilize disposable pipette tips. We believe that the Mago® 4 will also allow us to offer an enhanced automation solution to those customers that prefer a more compact, lower-priced instrument with features and benefits similar to many of the other instruments currently offered in the market place. We plan to submit a 510(k) application for the Mago® 4 to the FDA and, if and when approved, to begin our commercial launch of the Mago® 4 in the U.S. market.”
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. Teva Pharmaceutical Industries Limited, through its wholly-owned IVAX Corporation subsidiary, owns approximately 72% 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, without limitation: risks and uncertainties regarding thePARSEC® System, including, without limitation, that thePARSEC® Systemmay not perform as or be available when expected, that IVAX Diagnostics’ international activities associated with thePARSEC® Systemmay be impacted by the delay in the full commercial release of thePARSEC® System, that IVAX Diagnostics may not be able to submit its 510(k) application for thePARSEC® System to the FDA when expected or at all, that IVAX Diagnostics may not be able to obtain 510(k) clearance from the FDA for thePARSEC® Systemwhen expected or at all, that IVAX Diagnostics may not be successful in its marketing of thePARSEC® System, that customers may not integrate thePARSEC® System into their operations as readily as expected, and that sales and reagent rentals of thePARSEC® System may adversely affect sales and reagent rentals of theMago® 4; risks and uncertainties regarding theMago® 4, including, without limitation, that theMago® 4may not perform as or be available when expected, that IVAX Diagnostics may not be able to submit its 510(k) application for theMago® 4to the FDA when expected or at all, that IVAX Diagnostics may not be able to obtain 510(k) clearance from the FDA for theMago® 4when expected or at all, that IVAX Diagnostics may not be able to obtain all necessary regulatory approvals for theMago® 4 when expected or at all, that IVAX Diagnostics may not be successful in its marketing of theMago® 4, that customers may not integrate theMago® 4into their operations as readily as expected, and that sales and reagent rentals of theMago® 4 may adversely affect sales and reagent rentals of thePARSEC® System; that improved financial performance or results may not occur; 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 risks and uncertainties set forth above, investors should consider the economic, competitive, governmental, technological and other risks and uncertainties discussed in IVAX Diagnostics’ filings with the Securities and Exchange Commission, including, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in such filings.
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| | | | | | | | |
| Three Months Ended March 31, | | 2007 | | | 2006 | |
Net revenues | | $ | 4,946,190 | | | $ | 4,718,385 | |
Cost of sales | | | 1,958,381 | | | | 1,984,653 | |
| | | | | | | | |
Gross profit | | | 2,987,809 | | | | 2,733,732 | |
| | | | | | | | |
| | |
Operating expenses: | | | | | | | | |
Selling | | | 1,353,416 | | | | 1,491,835 | |
General and administrative | | | 1,454,634 | | | | 1,438,797 | |
Research and development | | | 472,010 | | | | 492,548 | |
| | | | | | | | |
Total operating expenses | | | 3,280,060 | | | | 3,423,180 | |
| | | | | | | | |
| | |
Loss from operations | | | (292,251 | ) | | | (689,448 | ) |
| | | | | | | | |
| | |
Other income: | | | | | | | | |
Interest income | | | 88,983 | | | | 119,787 | |
Other expense, net | | | 554 | | | | (10,907 | ) |
| | | | | | | | |
Total other income, net | | | 89,537 | | | | 108,880 | |
| | | | | | | | |
| | |
Loss before income taxes | | | (202,714 | ) | | | (580,568 | ) |
| | |
Provision for income taxes | | | 35,572 | | | | 15,606 | |
| | | | | | | | |
| | |
Loss before cumulative effect of change in accounting principle | | | (238,286 | ) | | | (596,174 | ) |
| | |
Cumulative effect of change in accounting principle | | | — | | | | (201,000 | ) |
| | | | | | | | |
| | |
Net loss | | $ | (238,286 | ) | | $ | (797,174 | ) |
| | | | | | | | |
Net loss per share, before cumulative effect of change in accounting principle | | | | | | | | |
Basic and diluted | | $ | (0.01 | ) | | $ | (0.02 | ) |
| | | | | | | | |
| | |
Cumulative effect of change in accounting principle, per share | | | | | | | | |
Basic and diluted | | $ | — | | | $ | (0.01 | ) |
| | | | | | | | |
| | |
Net loss per share | | | | | | | | |
Basic and diluted | | $ | (0.01 | ) | | $ | (0.03 | ) |
| | | | | | | | |
| | |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING: | | | | | | | | |
Basic | | | 27,649,887 | | | | 27,623,832 | |
| | | | | | | | |
Diluted | | | 27,649,887 | | | | 27,623,832 | |
| | | | | | | | |
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| | | | | | | | |
| | | March 31, 2007 | | | December 31,
2006 | |
| | | (Unaudited) | | | | |
| ASSETS | | | | | | | | |
Current assets: | | | | | | | | |
Cash and cash equivalents | | $ | 2,452,070 | | | $ | 1,995,730 | |
Marketable securities | | | 6,725,000 | | | | 6,650,000 | |
Accounts receivable, net of allowances for doubtful accounts of $1,086,584 in 2007 and $1,093,070 in 2006 | | | 6,952,170 | | | | 7,489,272 | |
Inventories, net | | | 5,798,681 | | | | 5,557,528 | |
Other current assets | | | 1,071,268 | | | | 1,183,571 | |
| | | | | | | | |
Total current assets | | | 22,999,189 | | | | 22,876,101 | |
| | |
Property, plant and equipment, net | | | 2,253,922 | | | | 2,301,580 | |
Equipment on lease | | | 333,626 | | | | 386,762 | |
Product license | | | 1,255,936 | | | | 1,255,936 | |
Goodwill, net | | | 6,722,725 | | | | 6,722,725 | |
Other assets | | | 165,862 | | | | 163,998 | |
| | | | | | | | |
Total assets | | $ | 33,731,260 | | | $ | 33,707,102 | |
| | | | | | | | |
| | |
| LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | | | | | |
| | |
Current liabilities: | | | | | | | | |
Accounts payable | | $ | 1,053,450 | | | $ | 935,896 | |
Accrued license payable | | | 532,786 | | | | 526,800 | |
Accrued expenses and other current liabilities | | | 3,051,414 | | | | 3,048,285 | |
| | | | | | | | |
Total current liabilities | | | 4,637,650 | | | | 4,510,981 | |
| | | | | | | | |
| | |
Other long-term liabilities: | | | | | | | | |
Deferred tax liabilities | | | 587,962 | | | | 572,089 | |
Other long-term liabilities | | | 909,633 | | | | 885,890 | |
| | | | | | | | |
Total other long-term liabilities | | | 1,497,595 | | | | 1,457,979 | |
| | | | | | | | |
| | |
Commitments and contingencies | | | | | | | | |
| | |
Shareholders’ equity: | | | | | | | | |
Common stock, $0.01 par value, authorized 50,000,000 shares, issued and outstanding 27,649,887 in 2007 and 2006 | | | 276,498 | | | | 276,498 | |
Capital in excess of par value | | | 40,799,663 | | | | 40,781,825 | |
Accumulated deficit | | | (13,014,488 | ) | | | (12,776,202 | ) |
Accumulated other comprehensive loss | | | (465,658 | ) | | | (543,979 | ) |
| | | | | | | | |
Total shareholders’ equity | | | 27,596,015 | | | | 27,738,142 | |
| | | | | | | | |
Total liabilities and shareholders’ equity | | $ | 33,731,260 | | | $ | 33,707,102 | |
| | | | | | | | |
| | |
| Contact: | | Duane M. Steele |
| | IVAX Diagnostics, Inc. |
| | 305-324-2338 |
| | www.ivaxdiagnostics.com |
