Vicuron Pharmaceuticals Announces Fourth Quarter 2004 Financial
Results 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 DATASOURCE: Vicuron
Pharmaceuticals Inc. CONTACT: Dov A. Goldstein, M.D., of Vicuron
Pharmaceuticals Inc., +1-610-205-2312, or ; or E. Blair Schoeb of
WeissComm Partners, +1-917-432-9275, or ; or Aline Schimmel of
Burns McClellan Inc., +1-212-213-0006, or , both for Vicuron
Pharmaceuticals Inc. Web site: http://www.vicuron.com/
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