Exhibit 99.1
IVAX DIAGNOSTICS REPORTS 2008 NET INCOME
MIAMI—(BUSINESS WIRE)—March 16, 2009—IVAX Diagnostics, Inc. (AMEX:IVD) today announced financial results for the quarter and year ended December 31, 2008.
Financial Results
IVAX Diagnostics reported net income of $196,000 for the year ended December 31, 2008, compared to a net loss of $10,434,000 for the year ended December 31, 2007. Net loss for the fourth quarter of 2008 was $465,000, compared to net loss of $1,892,000 for the fourth quarter of 2007. Excluding the one-time charges described below, IVAX Diagnostics reported net income of $756,000 for the year ended December 31, 2008 compared to a net loss of $1,369,000 for the year ended December 31, 2007, and net income of $95,000 for the fourth quarter of 2008 compared to net income of $106,000 for the fourth quarter of 2007.
IVAX Diagnostics reported net revenues of $20,819,000 for the year ended December 31, 2008, an increase of 4.2% compared to net revenues of $19,976,000 for the year ended December 31, 2007. Net revenues for the fourth quarter of 2008 were $4,797,000, a decrease of 2.8% compared to net revenues of $4,937,000 for the fourth quarter of 2007.
For the year ended December 31, 2008, IVAX Diagnostics’ results included a $560,000 one-time non-cash write-off, which had no tax impact, of a portion of IVAX Diagnostics’ product license for hepatitis technology during the fourth quarter of 2008. For the year ended December 31, 2007, IVAX Diagnostics’ results included the tax-affected impact of $9,064,000 of one-time charges, which were composed of one-time non-cash write-offs of goodwill totaling $5,852,000 and PARSEC® System related assets totaling $1,674,000, and one-time severance related costs of $1,998,000 incurred in connection with management and other personnel changes during the fourth quarter of 2007 and included in general and administrative expenses.
Management’s Comments
Charles Struby, Chief Executive Officer of IVAX Diagnostics, said, “Showing a profit for the year reflects IVAX Diagnostics’ efforts to better manage expenses while growing our consolidated net revenues. As we look at 2009 and beyond, we intend to focus on increasing our top line growth through both organic and strategic collaborations while continuing our efforts to improve operational efficiencies.”
Kevin Clark, Chief Operating Officer and former acting Chief Executive Officer of IVAX Diagnostics, said, “The efforts of our dedicated employees have culminated in considerable improvements to our operating results, including significantly reduced operating expenses. Additionally, I am pleased that IVAX Diagnostics remains debt free and has maintained its strong cash position, supplemented by our receipt in January 2009 of the full par value of all of our investments in auction rate securities. Further, the addition of Dr. Struby’s leadership and experience will enhance the depth and breadth of IVAX Diagnostics’ executive management team.”
Non-GAAP Financial Information
Under accounting principles generally accepted in the United States (“GAAP”), “net income (loss)” and “basic and diluted earnings (loss) per share” include all charges and other items for the periods reported. To supplement IVAX Diagnostics’ consolidated financial statements presented in accordance with GAAP, IVAX Diagnostics has now begun providing non-GAAP measures of financial performance. Accordingly, in this press release, IVAX Diagnostics is also providing net income (loss) and basic and diluted earnings (loss) per share for the periods presented excluding the one-time charges described above.
IVAX Diagnostics believes that comparing its period-to-period financial results without giving effect to the one-time charges described above may be helpful to investors to permit comparison of its period-to-period financial results on a more uniform basis. For the same reasons, management uses these non-GAAP financial measures to evaluate IVAX Diagnostics’ current performance against its historical performance and to plan its future business activities. These measures should not be considered alternatives to measures computed in accordance with GAAP, nor should they be considered indicators of IVAX Diagnostics’ overall financial performance. Adjusted net income (loss) and adjusted basic and diluted earnings (loss) per share are limited by the fact that companies may not necessarily compute each in the same manner, thereby making these measures less useful than the same measures calculated in accordance with GAAP.
Tables reconciling net income (loss) and earnings (loss) per share on a GAAP basis to net income (loss) and earnings (loss) per share as adjusted to exclude the one-time charges described above are attached to this press release.
About IVAX Diagnostics, Inc.
IVAX Diagnostics, Inc., headquartered in Miami, Florida, develops, manufactures and distributes in the United States and internationally, proprietary diagnostic reagents, test kits and instrumentation, primarily for autoimmune and infectious diseases, through its three subsidiaries: Diamedix Corporation, Delta Biologicals S.r.l. and ImmunoVision, 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: that IVAX Diagnostics’ efforts to contain expenses may not result in further reductions in expenses; that IVAX Diagnostics may not achieve revenue or income growth; that IVAX Diagnostics may not achieve further operational efficiencies; that IVAX Diagnostics may not achieve improved financial performance on a sustained basis, or at all; that IVAX Diagnostics may not receive, when expected or at all, regulatory approval of its hepatitis products that are based upon the product license of hepatitis technology; that IVAX Diagnostics’ hepatitis products that are based upon the product license of hepatitis technology may be delayed and may not be commercially launched when anticipated or at all; that IVAX Diagnostics may be required to write-off all or a portion of the remaining amount of the product license for hepatitis technology if it does not receive regulatory approval for the hepatitis products when expected or if it delays the commercial launch of the hepatitis products; that IVAX Diagnostics may not achieve organic growth; that IVAX Diagnostics may not identify or consummate strategic collaborations; that, in the event IVAX Diagnostics consummates strategic collaborations, any such strategic collaborations may not be successful or otherwise result in improved financial performance for IVAX Diagnostics; 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| | | | | | | | | | | | | | | | |
| | Three Months | | | Twelve Months | |
Period Ended December 31, | | 2008 | | | 2007 | | | 2008 | | | 2007 | |
NET REVENUE | | $ | 4,797,121 | | | $ | 4,936,752 | | | $ | 20,819,175 | | | $ | 19,975,870 | |
| | | | |
COST OF SALES | | | 2,053,223 | | | | 2,089,927 | | | | 8,388,132 | | | | 8,399,399 | |
| | | | | | | | | | | | | | | | |
Gross profit | | | 2,743,898 | | | | 2,846,825 | | | | 12,431,043 | | | | 11,576,471 | |
| | | | | | | | | | | | | | | | |
| | | | |
OPERATING EXPENSES: | | | | | | | | | | | | | | | | |
Selling | | | 1,192,689 | | | | 1,402,397 | | | | 4,932,981 | | | | 5,485,532 | |
General and administrative | | | 1,217,745 | | | | 2,959,854 | | | | 5,364,041 | | | | 7,730,164 | |
Research and development | | | 500,248 | | | | 539,339 | | | | 1,817,047 | | | | 2,152,114 | |
Write-off of PARSEC® related assets | | | — | | | | — | | | | — | | | | 1,673,824 | |
Impairment of product license and goodwill | | | 560,000 | | | | — | | | | 560,000 | | | | 5,852,435 | |
| | | | | | | | | | | | | | | | |
Total operating expenses | | | 3,470,682 | | | | 4,901,590 | | | | 12,674,069 | | | | 22,894,069 | |
| | | | | | | | | | | | | | | | |
| | | | |
Loss from operations | | | (726,784 | ) | | | (2,054,765 | ) | | | (243,026 | ) | | | (11,317,598 | ) |
| | | | | | | | | | | | | | | | |
| | | | |
OTHER INCOME, NET: | | | | | | | | | | | | | | | | |
Interest income | | | 126,886 | | | | 158,852 | | | | 292,231 | | | | 435,575 | |
Other income (expense), net | | | 144,846 | | | | 37,843 | | | | 253,217 | | | | 119,515 | |
| | | | | | | | | | | | | | | | |
Total other income, net | | | 271,732 | | | | 196,695 | | | | 545,448 | | | | 555,090 | |
| | | | | | | | | | | | | | | | |
| | | | |
Income (loss) before income taxes | | | (455,052 | ) | | | (1,858,070 | ) | | | 302,422 | | | | (10,762,508 | ) |
| | | | |
INCOME TAX PROVISION (BENEFIT) | | | 10,278 | | | | 34,070 | | | | 106,414 | | | | (328,769 | ) |
| | | | | | | | | | | | | | | | |
| | | | |
Net income (loss) | | $ | (465,330 | ) | | $ | (1,892,140 | ) | | $ | 196,008 | | | $ | (10,433,739 | ) |
| | | | | | | | | | | | | | | | |
| | | | |
Income (loss) per share | | | | | | | | | | | | | | | | |
Basic and diluted | | $ | (0.02 | ) | | $ | (0.07 | ) | | $ | 0.01 | | | $ | (0.38 | ) |
| | | | | | | | | | | | | | | | |
| | | | |
WEIGHTED AVERAGE SHARES OUTSTANDING: | | | | | | | | | | | | | | | | |
Basic | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | |
| | | | | | | | | | | | | | | | |
Diluted | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | |
| | | | | | | | | | | | | | | | |
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 2008 AND 2007
| | | | | | | | |
| | 2008 | | | 2007 | |
ASSETS | | | | | | | | |
| | |
CURRENT ASSETS: | | | | | | | | |
Cash and cash equivalents | | $ | 4,420,900 | | | $ | 3,900,564 | |
Marketable securities | | | 4,100,000 | | | | 1,925,000 | |
Accounts receivable, net of allowances for doubtful accounts of $358,268 and $1,052,797, respectively | | | 5,789,901 | | | | 6,287,654 | |
Inventories, net | | | 4,678,069 | | | | 4,013,312 | |
Other current assets | | | 271,069 | | | | 374,579 | |
| | | | | | | | |
Total current assets | | | 19,259,939 | | | | 16,501,109 | |
| | |
PROPERTY, PLANT AND EQUIPMENT: | | | | | | | | |
Land | | | 352,957 | | | | 352,957 | |
Buildings and improvements | | | 3,017,017 | | | | 3,039,902 | |
Machinery and equipment | | | 2,716,258 | | | | 2,534,084 | |
Furniture and fixtures | | | 1,898,191 | | | | 1,887,369 | |
| | | | | | | | |
| | | 7,984,423 | | | | 7,814,312 | |
Less – Accumulated depreciation | | | (6,135,786 | ) | | | (5,969,020 | ) |
| | | | | | | | |
| | | 1,848,637 | | | | 1,845,292 | |
| | |
OTHER ASSETS: | | | | | | | | |
Marketable securities | | | — | | | | 4,100,000 | |
Goodwill | | | 870,290 | | | | 870,290 | |
Equipment on lease, net | | | 210,743 | | | | 163,113 | |
Product license | | | 682,936 | | | | 1,242,936 | |
Other | | | 175,523 | | | | 1,045,592 | |
| | | | | | | | |
| | | 1,939,492 | | | | 7,421,931 | |
| | | | | | | | |
| | |
Total assets | | $ | 23,048,068 | | | $ | 25,768,332 | |
| | | | | | | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | | | | | |
| | |
CURRENT LIABILITIES: | | | | | | | | |
Accounts payable | | $ | 698,693 | | | $ | 1,217,408 | |
Accrued license payable | | | 140,062 | | | | 147,184 | |
Accrued expenses | | | 3,116,755 | | | | 5,404,372 | |
| | | | | | | | |
Total current liabilities | | | 3,955,510 | | | | 6,768,964 | |
| | | | | | | | |
| | |
OTHER LONG-TERM LIABILITIES: | | | | | | | | |
Deferred tax liabilities | | | 238,200 | | | | 174,708 | |
Other long-term liabilities | | | 902,551 | | | | 850,177 | |
| | | | | | | | |
Total other long-term liabilities | | | 1,140,751 | | | | 1,024,885 | |
| | | | | | | | |
| | |
COMMITMENTS AND CONTINGENCIES | | | | | | | | |
| | |
SHAREHOLDERS’ EQUITY: | | | | | | | | |
Common stock, par value $0.01, authorized 50,000,000 shares, issued and outstanding 27,649,887 in 2008 and 2007 | | | 276,498 | | | | 276,498 | |
Additional paid-in capital | | | 41,065,840 | | | | 40,910,677 | |
Accumulated deficit | | | (23,013,933 | ) | | | (23,209,941 | ) |
Accumulated other comprehensive loss | | | (376,598 | ) | | | (2,751 | ) |
| | | | | | | | |
Total shareholders’ equity | | | 17,951,807 | | | | 17,974,483 | |
| | | | | | | | |
Total liabilities and shareholders’ equity | | $ | 23,048,068 | | | $ | 25,768,332 | |
| | | | | | | | |
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
Reconciliation of Non-GAAP Measures to GAAP
| | | | | | | | | | | | | | | | | | | | | | | |
Statements of Operations Data: (unaudited) | | Twelve Months Ended December 31, 2008 | | | Twelve Months Ended December 31, 2007 | |
| | Non- GAAP1 | | Adjustments | | | GAAP3 | | | Non- GAAP2 | | | Adjustments | | | GAAP3 | |
NET REVENUES | | $ | 20,819,175 | | | — | | | $ | 20,819,175 | | | $ | 19,975,870 | | | | — | | | $ | 19,975,870 | |
| | | | | | |
COST OF SALES | | | 8,388,132 | | | — | | | | 8,388,132 | | | | 8,399,399 | | | | — | | | | 8,399,399 | |
| | | | | | | | | | | | | | | | | | | | | | | |
Gross Profit | | | 12,431,043 | | | — | | | | 12,431,043 | | | | 11,576,471 | | | | — | | | | 11,576,471 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
OPERATING EXPENSES: | | | | | | | | | | | | | | | | | | | | | | | |
Selling | | | 4,932,981 | | | — | | | | 4,932,981 | | | | 5,485,532 | | | | — | | | | 5,485,532 | |
General and administrative | | | 5,364,041 | | | — | | | | 5,364,041 | | | | 5,732,164 | | | | 1,998,000 | | | | 7,730,164 | |
Research and development | | | 1,817,047 | | | — | | | | 1,817,047 | | | | 2,152,114 | | | | — | | | | 2,152,114 | |
Write-off PARSEC® related assets | | | — | | | — | | | | — | | | | — | | | | 1,673,824 | | | | 1,673,824 | |
Impairment of product license and goodwill | | | — | | | 560,000 | | | | 560,000 | | | | — | | | | 5,852,435 | | | | 5,852,435 | |
| | | | | | | | | | | | | | | | | | | | | | | |
Total operating expenses | | | 12,114,069 | | | 560,000 | | | | 12,674,069 | | | | 13,369,810 | | | | 9,524,259 | | | | 22,894,069 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
Income (loss) from operations | | | 316,974 | | | (560,000 | ) | | | (243,026 | ) | | | (1,793,339 | ) | | | (9,524,259 | ) | | | (11,317,598 | ) |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
OTHER INCOME, NET: | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
Interest income | | | 292,231 | | | — | | | | 292,231 | | | | 435,575 | | | | — | | | | 435,575 | |
Other income (expense), net | | | 253,217 | | | — | | | | 253,217 | | | | 119,515 | | | | — | | | | 119,515 | |
| | | | | | | | | | | | | | | | | | | | | | | |
Total other income, net | | | 545,448 | | | — | | | | 545,448 | | | | 555,090 | | | | — | | | | 555,090 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
Income (loss) before income taxes | | | 862,422 | | | (560,000 | ) | | | 302,422 | | | | (1,238,249 | ) | | | (9,524,259 | ) | | | (10,762,508 | ) |
| | | | | | |
INCOME TAX PROVISION (BENEFIT) | | | 106,414 | | | — | | | | 106,414 | | | | 131,231 | | | | (460,000 | ) | | | (328,769 | ) |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
Net income (loss) | | $ | 756,008 | | $ | (560,000 | ) | | $ | 196,008 | | | $ | (1,369,480 | ) | | $ | (9,064,259 | ) | | $ | (10,433,739 | ) |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
Income (loss) per share basic and diluted | | $ | 0.03 | | $ | (0.02 | ) | | $ | 0.01 | | | $ | (0.05 | ) | | $ | (0.33 | ) | | $ | (0.38 | ) |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
WEIGHTED AVERAGE SHARES OUTSTANDING: | | | | | | | | | | | | | | | | | | | | | | | |
Basic | | | 27,649,887 | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | |
| | | | | | | | | | | | | | | | | | | | | | | |
Diluted | | | 27,649,887 | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | |
| | | | | | | | | | | | | | | | | | | | | | | |
(1) | Non-GAAP amounts for the year ended December 31, 2008 exclude the impact of a $560,000 one-time non-cash write-off of a portion of IVAX Diagnostics’ product license for hepatitis technology during the fourth quarter of 2008. |
(2) | Non-GAAP amounts for the year ended December 31, 2007 exclude the effect of one-time charges, including the tax impact, of one-time non-cash write-offs of goodwill totaling $5,852,000 and PARSEC® System related assets totaling $1,674,000, and one-time severance related costs of $1,998,000 incurred in connection with management and other personnel changes during the fourth quarter of 2007 and included in general and administrative expenses. |
(3) | Reflects operating results in accordance with accounting principles generally accepted in the United States (“GAAP”). |
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
Reconciliation of Non-GAAP Measures to GAAP
| | | | | | | | | | | | | | | | | | | | | | | | |
Statements of Operations Data: (unaudited) | | Three Months Ended December 31, 2008 | | | Three Months Ended December 31, 2007 | |
| | Non- GAAP1 | | | Adjustments | | | GAAP3 | | | Non- GAAP2 | | | Adjustments | | | GAAP3 | |
NET REVENUES | | $ | 4,797,121 | | | | — | | | $ | 4,797,121 | | | $ | 4,936,752 | | | | — | | | $ | 4,936,752 | |
| | | | | | |
COST OF SALES | | | 2,053,223 | | | | — | | | | 2,053,223 | | | | 2,089,927 | | | | — | | | | 2,089,927 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Gross Profit | | | 2,743,898 | | | | — | | | | 2,743,898 | | | | 2,846,825 | | | | — | | | | 2,846,825 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
OPERATING EXPENSES: | | | | | | | | | | | | | | | | | | | | | | | | |
Selling | | | 1,192,689 | | | | — | | | | 1,192,689 | | | | 1,402,397 | | | | — | | | | 1,402,397 | |
General and administrative | | | 1,217,745 | | | | — | | | | 1,217,745 | | | | 961,854 | | | | 1,998,000 | | | | 2,959,854 | |
Research and development | | | 500,248 | | | | — | | | | 500,248 | | | | 539,339 | | | | — | | | | 539,339 | |
Write-off PARSEC® related assets | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | |
Impairment of Product license and goodwill | | | — | | | | 560,000 | | | | 560,000 | | | | — | | | | — | | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Total operating expenses | | | 2,910,682 | | | | 560,000 | | | | 3,470,682 | | | | 2,903,590 | | | | 1,998,000 | | | | 4,901,590 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
Loss from operations | | | (166,784 | ) | | | (560,000 | ) | | | (726,784 | ) | | | (56,765 | ) | | | (1,998,000 | ) | | | (2,054,765 | ) |
| | | | | | | | | | | | | | | | | | | | | �� | | | |
| | | | | | |
OTHER INCOME, NET: | | | | | | | | | | | | | | | | | | | | | | | | |
Interest income | | | 126,886 | | | | — | | | | 126,886 | | | | 158,852 | | | | — | | | | 158,852 | |
Other income (expense), net | | | 144,846 | | | | — | | | | 144,846 | | | | 37,843 | | | | — | | | | 37,843 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Total other income, net | | | 271,732 | | | | — | | | | 271,732 | | | | 196,695 | | | | — | | | | 196,695 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
Income (loss) before income taxes | | | 104,948 | | | | (560,000 | ) | | | (455,052 | ) | | | 139,930 | | | | (1,998,000 | ) | | | (1,858,070 | ) |
| | | | | | |
INCOME TAX PROVISION (BENEFIT) | | | 10,278 | | | | — | | | | 10,278 | | | | 34,070 | | | | — | | | | 34,070 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
Net income (loss) | | $ | 94,670 | | | $ | (560,000 | ) | | $ | (465,330 | ) | | $ | 105,860 | | | $ | (1,998,000 | ) | | $ | (1,892,140 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
Income (loss) per share basic and diluted | | $ | 0.00 | | | $ | (0.02 | ) | | $ | (0.02 | ) | | $ | 0.00 | | | $ | (0.07 | ) | | $ | (0.07 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | |
WEIGHTED AVERAGE SHARES OUTSTANDING: | | | | | | | | | | | | | | | | | | | | | | | | |
Basic | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Diluted | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | | | | 27,649,887 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
(1) | Non-GAAP amounts for the three months ended December 31, 2008 exclude the impact of a $560,000 one-time non-cash write-off of a portion of IVAX Diagnostics’ product license for hepatitis technology during the fourth quarter of 2008. |
(2) | Non-GAAP amounts for the three months ended December 31, 2007 exclude the effect of one-time severance related costs of $1,998,000 incurred in connection with management and other personnel changes during the fourth quarter of 2007 and included in general and administrative expenses. |
(3) | Reflects operating results in accordance with accounting principles generally accepted in the United States (“GAAP”). |
| | |
Contact: | | Duane M. Steele |
| | IVAX Diagnostics, Inc. |
| | 305-324-2338 |
| | www.ivaxdiagnostics.com |