Exhibit 99.1
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Contacts: | | | | |
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Dov A. Goldstein, M.D. | | E. Blair Schoeb | | Heather May |
Vicuron Pharmaceuticals Inc. | | WeissComm Partners | | Burns McClellan Inc. |
610-205-2312 | | 212-331-7813 | | 212-213-0006 |
dgoldstein@vicuron.com | | Blair@weisscommpartners.com | | hmay@burnsmc.com |
VICURON PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2005
FINANCIAL RESULTS
King of Prussia, Penn., May 5, 2005— Vicuron Pharmaceuticals Inc. (NASDAQ and MICU: Nuovo Mercato) today reported financial results for the first quarter ended March 31, 2005.
Total revenues for the first quarter of 2005 were $1.8 million compared with $1.9 million for the first quarter of 2004. Total operating expenses were $17.9 million in the first quarter of 2005 compared to $26.1 million during the first quarter of 2004.
For the first quarter of 2005, Vicuron reported a net loss of $15.4 million, or a net loss per share of $0.25 on 60.6 million weighted average shares outstanding. This compares to a net loss of $23.5 million, or $0.44 per share on 54.0 million weighted average shares outstanding for the first quarter of 2004.
At March 31, 2005, cash and cash equivalents and unrestricted marketable securities totaled approximately $135.7 million.
“Over the past few months we advanced our pipeline of product candidates for seriously ill patients moving us closer to commercialization. We announced Phase 3 trial results demonstrating the superiority of anidulafungin versus fluconazole, showing the promise of anidulafungin, if approved, as a potential new treatment for candidiasis/candidemia, the most common hospital-acquired fungal infection,” said George F. Horner III, President and Chief Executive Officer of Vicuron. “In addition, during this quarter, we announced that our collaboration with Pfizer to develop oxazolidinones, one of the first new major classes of antibiotics to enter the market in more than 30 years, has been extended for another year.”
About Vicuron Pharmaceuticals
Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients. The company has two New Drug Applications pending with the U.S. Food and Drug Administration for its lead products, dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram-positive infections, and anidulafungin, a novel antifungal agent. Vicuron’s versatile research engine integrates industry-leading expertise in functional genomics, mechanism-based drug design and combinatorial and medicinal chemistry. These approaches are yielding promising novel and next-generation compounds, many of which are in the later stages of preclinical development. In addition, the company has research collaborations with leading pharmaceutical companies, such as Pfizer.
Forward-Looking Statements
This news release contains forward-looking statements that predict or describe future events or trends. The matters described in these forward-looking statements are subject to known and unknown risks, uncertainties and other unpredictable factors, many of which are beyond Vicuron’s control. Vicuron faces many risks that could cause its actual performance to differ materially from the results predicted by its forward-looking statements, including the possibilities that clinical trials and the results thereof might be delayed or unsuccessful, that the timing of the filing of any new drug application or any amendment to a new drug application might be delayed, that clinical trials might indicate that a product candidate is unsafe or ineffective, that the FDA might require additional information to be submitted and additional actions to be taken before it will make any decision, that any filed new drug application may not be approved by the FDA, that ongoing proprietary and collaborative research might not occur or yield useful results, that the pipeline may not yield a new clinical candidate or a commercial product, that a third party may not be willing to license product candidates on terms acceptable to us or at all, that competitors might develop superior substitutes for Vicuron’s products or market these competitive products more effectively, that a sales force may not be developed as contemplated and that one or more of Vicuron’s product candidates may not be commercialized successfully. The reports that Vicuron files with the U.S. Securities and Exchange Commission contain a fuller description of these and many other risks to which Vicuron is subject. Because of those risks, Vicuron’s actual results, performance or achievements may differ materially from the results, performance or achievements contemplated by its forward-looking statements. The information set forth in this news release represents management’s current expectations and intentions. Vicuron assumes no responsibility to issue updates to the forward-looking matters discussed in this news release.
VICURON PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share amounts)
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| | Three Months Ended
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| | March 31, 2005
| | | March 31, 2004
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Revenues: | | | | | | | | |
Collaborative research and development and contract services | | $ | 1,627 | | | $ | 1,792 | |
License fees and milestones | | | 143 | | | | 136 | |
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Total revenues | | | 1,770 | | | | 1,928 | |
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Operating expenses: | | | | | | | | |
Research and development | | | 13,280 | | | | 22,035 | |
General and administrative | | | 4,658 | | | | 4,071 | |
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Total operating expenses | | | 17,938 | | | | 26,106 | |
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Loss from operations | | | (16,168 | ) | | | (24,178 | ) |
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Other income (expense): | | | | | | | | |
Interest income | | | 851 | | | | 686 | |
Interest expense | | | (7 | ) | | | (28 | ) |
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Net loss before income tax expense | | | (15,324 | ) | | | (23,520 | ) |
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Income tax expense | | | 92 | | | | 0 | |
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Net loss | | $ | (15,416 | ) | | $ | (23,520 | ) |
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Net loss per share: | | | | | | | | |
Basic and diluted | | $ | (0.25 | ) | | $ | (0.44 | ) |
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Weighted average shares | | | 60,571 | | | | 54,029 | |
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VICURON PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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| | (unaudited) March 31, 2005
| | | December 31, 2004
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ASSETS | | | | | | | | |
Current assets: | | | | | | | | |
Cash and cash equivalents | | $ | 104,534 | | | $ | 121,144 | |
Marketable securities | | | 31,171 | | | | 34,127 | |
Accounts receivable, net | | | 6,142 | | | | 6,232 | |
Prepaid expenses and other current assets | | | 4,780 | | | | 8,310 | |
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Total current assets | | | 146,627 | | | | 169,813 | |
Property, plant and equipment | | | 56,375 | | | | 58,668 | |
Intangible assets, net | | | 22,240 | | | | 24,230 | |
Long-term receivables | | | 12,340 | | | | 12,222 | |
Long-term marketable securities-restricted | | | 2,971 | | | | 3,256 | |
Other assets | | | 2,785 | | | | 1,837 | |
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Total assets | | $ | 243,338 | | | $ | 270,026 | |
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LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | | |
Current liabilities: | | | | | | | | |
Accounts payable | | $ | 7,577 | | | $ | 12,473 | |
Accrued liabilities | | | 6,982 | | | | 9,747 | |
Current portion of long term debt | | | 1,169 | | | | 1,225 | |
Current portion of deferred revenue | | | 379 | | | | 550 | |
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Total current liabilities | | | 16,107 | | | | 23,995 | |
Long-term debt, less current portion | | | 9,603 | | | | 10,066 | |
Deferred revenue, less current portion | | | 1,750 | | | | 1,750 | |
Other long-term liabilities | | | 5,266 | | | | 4,624 | |
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Total liabilities | | | 32,726 | | | | 40,435 | |
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Stockholders’ equity: | | | | | | | | |
Common stock | | | 61 | | | | 60 | |
Additional paid-in capital | | | 605,487 | | | | 602,011 | |
Deferred stock compensation | | | (114 | ) | | | (179 | ) |
Accumulated other comprehensive income | | | 25,840 | | | | 32,945 | |
Accumulated deficit | | | (420,662 | ) | | | (405,246 | ) |
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Total stockholders’ equity | | | 210,612 | | | | 229,591 | |
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Total liabilities and stockholders’ equity | | $ | 243,338 | | | $ | 270,026 | |
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