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Vicuron Pharmaceuticals, Inc. (MICU) Announces Fourth Quarter 2004 Financial Results

10/19/2005 5:12:59 PM

KING OF PRUSSIA, Pa., March 10 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today reported financial results for the fourth quarter and year ended December 31, 2004.

Total revenues for the fourth quarter of 2004 were $2.7 million compared with $2.8 million for the fourth quarter of 2003. Total operating expenses were $20.5 million in the fourth quarter of 2004 compared to $25.5 million during the fourth quarter of 2003.

For the fourth quarter of 2004, Vicuron reported a net loss of $15.5 million, or a net loss per share of $0.26 on 59.3 million weighted average shares outstanding. This compares to a net loss of $22.2 million, or $0.41 per share on 53.9 million weighted average shares outstanding for the fourth quarter of 2003.

Total revenues for the year were $8.4 million compared to $9.6 million for 2003. Total operating expenses for the year were $90.8 million compared to $186.0 million for 2003. This decrease is largely due to a $94.5 million non- cash in-process R&D charge taken due to the 2003 merger with Biosearch Italia S.p.A.

For the year ended December 31, 2004, Vicuron reported a net loss of $78.5 million, or a net loss per share of $1.40 on 56.0 million weighted average shares outstanding for the year. This compares to a net loss for 2003 of $174.1 million, or $3.69 per share on 47.2 million weighted average shares outstanding for the year. This decrease is largely due to a $94.5 million non-cash in-process R&D charge taken due to the 2003 merger with Biosearch Italia.

At December 31, 2004, cash, cash equivalents and unrestricted marketable securities totaled approximately $155.3 million.

"In 2004, we moved closer to becoming a commercial biopharmaceutical company. In December 2004, we filed a New Drug Application (NDA) for dalbavancin, our lead hospital antibiotic product, for complicated skin and soft tissue infection. We just received Priority Review status for this NDA from the FDA," said George F. Horner III, President and Chief Executive Officer of Vicuron. "In addition, during this quarter, we announced anidulafungin, our lead antifungal product candidate, demonstrated superiority versus fluconazole in the treatment of invasive candidiasis/candidemia."

For the 2005 fiscal year, Vicuron anticipates a net loss of $70 - $75 million from previous guidance of $65 - $70 million, however, this is offset by a lower than anticipated net loss of $78.5 million for 2004, which is below previous guidance of $87 - $92 million for that year.

Corporate and product highlights in 2004 include: -- raised an additional $74.5 million (excluding expenses) to continue to develop the company's focused pipeline of differentiated anti- infectives; -- completed enrollment of the phase 3 trial of anidulafungin in invasive candidiasis/candidemia; -- announced positive pivotal phase 3 data for dalbavancin in skin and soft tissue infections; -- announced phase 2 results that showed dalbavancin demonstrated superior efficacy to vancomycin in the treatment of Gram-positive catheter- related bloodstream infections; and -- presented 40 oral and poster presentations on the company's products and programs, including the novel lincosamide program, at the 44th annual ICAAC meeting in October. 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, natural products discovery, 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 Novartis and 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) Three Months Ended Twelve Months Ended Dec. 31, Dec. 31, Dec. 31, Dec. 31, 2004 2003 2004 2003 Revenues: Collaborative research and development and contract services $1,804 $1,875 $7,066 $7,929 License fees and milestones 895 895 1,306 1,679 Total revenues 2,699 2,770 8,372 9,608 Operating expenses: Research and development 14,355 21,897 68,538 77,893 General and administrative 6,149 3,645 22,303 13,531 Acquired in-process research and development -- -- -- 94,532 Total operating expenses 20,504 25,542 90,841 185,956 Loss from operations (17,805) (22,772) (82,469) (176,348) Other income (expense): Interest income 875 972 2,552 2,749 Interest expense (15) (351) (84) (506) Net loss before income tax benefit (16,945) (22,151) (80,001) (174,105) Income tax benefit (1,479) -- (1,479) -- Net loss after income tax benefit $(15,466) $(22,151) $(78,522) $(174,105) Net loss per share: Basic and diluted $(0.26) $(0.41) $(1.40) $(3.69) Weighted average shares 59,337 53,863 56,025 47,162 VICURON PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands) December 31, December 31, 2004 2003 ASSETS Current assets: Cash and cash equivalents $121,144 $113,361 Marketable securities 34,127 52,796 Accounts receivable, net 6,232 5,533 Prepaid expenses and other current assets 8,310 6,329 Total current assets 169,813 178,019 Property, plant and equipment 58,668 43,757 Intangible assets, net 24,230 23,373 Long-term receivables 12,222 9,787 Long-term marketable securities- restricted 3,256 3,232 Other assets 1,837 330 Total assets $270,026 $258,498 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $12,473 $13,986 Accrued liabilities 9,747 15,085 Current portion of long term debt 1,225 2,360 Current portion of deferred revenue 550 1,068 Total current liabilities 23,995 32,499 Long-term debt, less current portion 10,066 7,493 Deferred revenue, less current portion 1,750 1,750 Other long-term liabilities 4,624 2,973 Total liabilities 40,435 44,715 Stockholders' equity: Common stock 60 54 Additional paid-in capital 602,011 518,275 Deferred stock compensation (179) (454) Accumulated other comprehensive income 32,945 22,632 Accumulated deficit (405,246) (326,724) Total stockholders' equity 229,591 213,783 Total liabilities and stockholders' equity $270,026 $258,498

Vicuron Pharmaceuticals Inc.

CONTACT: Dov A. Goldstein, M.D., of Vicuron Pharmaceuticals Inc.,+1-610-205-2312, or; or E. Blair Schoeb of WeissCommPartners, +1-917-432-9275, or; or Aline Schimmelof Burns McClellan Inc., +1-212-213-0006, or, both forVicuron Pharmaceuticals Inc.

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