Vicuron Pharmaceuticals Announces Third Quarter 2004 Financial
Results KING OF PRUSSIA, Pa., Nov. 4 /PRNewswire-FirstCall/ --
Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today
reported financial results for the three and nine month periods
ended September 30, 2004. Total revenues for the third quarter of
2004 were $1.8 million compared with $2.8 million for the third
quarter of 2003. Total operating expenses were $17.7 in the third
quarter 2004 compared to $22.3 million during the third quarter of
2003. For the third quarter of 2004, Vicuron reported a net loss of
$15.4 million or a net loss per share of $0.28 on 54.9 million
weighted average shares. This compares to a net loss of $18.9
million or $0.36 per share on 52.8 million weighted average shares
outstanding for the third quarter of 2003. Total revenues for the
first nine months were $5.7 compared to $6.8 million for the same
period in 2003. Total operating expenses for the first nine months
of 2004 were $70.3 compared to $160.4 million for the first nine
months of 2003. For the nine months ended September 30, 2004,
Vicuron reported a net loss of $63.1 million or a net loss per
share of $1.16 on 54.5 million weighted average shares outstanding.
This compares to a net loss for the same period of 2003 of $152.0
million or $3.38 per share on 44.9 million weighted average shares
outstanding. At September 30, 2004, cash and cash equivalents and
unrestricted marketable securities totaled approximately $96.3
million, which does not include the net proceeds of $71.4 million
from the recently completed public offering. "In the third quarter
we achieved numerous corporate milestones that continue to advance
Vicuron. In August, we announced positive pivotal Phase 3 data with
dalbavancin for the potential treatment of skin and soft tissue
infections and, in September, we completed the enrollment of our
Phase 3 clinical trial of anidulafungin for the potential treatment
of invasive candidiasis/candidemia," said George F. Horner III,
President and Chief Executive Officer of Vicuron. "Following
discussions with the U.S. Food and Drug Administration, we now have
two defined paths towards regulatory approval for anidulafungin in
the United States. With net proceeds of approximately $71.4 million
from our recent public offering in September, we are well
positioned to continue to advance our product candidates. This past
weekend at the ICAAC annual meeting, 40 oral and poster
presentations highlighted the breadth and depth of our powerful
pipeline in and commitment to the area of differentiated
anti-infective agents." About Vicuron Vicuron Pharmaceuticals is a
biopharmaceutical company focused on discovering, developing,
manufacturing and commercializing vital medicine for seriously ill
patients. In May 2004, Vicuron received an approvable letter from
the FDA for its lead product anidulafungin for the treatment of
esophageal candidiasis. The company's other lead product,
dalbavancin, a novel intravenous antibiotic for the treatment of
serious Gram-positive infections, has completed Phase 3 clinical
trials. The company'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 and development collaborations with leading pharmaceutical
companies, such as Pfizer and Novartis. 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 our 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
statement. 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 Nine Months Ended Sept. 30, Sept. 30, Sept. 30, Sept. 30,
2004 2003 2004 2003 Revenues: Collaborative research and
development and contract services $1,692 $2,173 $5,262 $6,054
License fees and milestones 136 626 411 784 Total revenues 1,828
2,799 5,673 6,838 Operating expenses: Research and development
12,795 18,113 54,183 55,996 General and administrative 4,891 4,164
16,154 9,886 Acquired in-process research and development -- -- --
94,532 Total operating expenses 17,686 22,277 70,337 160,414 Loss
from operations (15,858) (19,478) (64,664) (153,576) Other income
(expense): Investment income 448 607 1,678 1,777 Interest expense
(16) (43) (69) (155) Net loss $(15,426) $(18,914)
$(63,055)$(151,954) Net loss per share: Basic and diluted $(0.28) $
(0.36) $(1.16) $(3.38) Weighted average shares 54,882 52,799 54,511
44,903 VICURON PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (unaudited) (in thousands) September 30, December 31, 2004
2003 ASSETS Current assets: Cash and cash equivalents $79,576
$113,361 Marketable securities 16,730 52,796 Accounts receivable,
net 5,013 5,533 Prepaid expenses and other current assets 5,689
6,329 Total current assets 107,008 178,019 Property, plant and
equipment 53,671 43,757 Intangible assets, net 23,356 23,373
Long-term receivables 11,411 9,787 Long-term marketable
securities-restricted 2,983 3,232 Other assets 328 330 Total assets
$198,757 $258,498 LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable $8,866 $13,986 Accrued liabilities
13,020 15,085 Current portion of long term debt 609 2,360 Current
portion of deferred revenue 839 1,068 Total current liabilities
23,334 32,499 Long-term debt, less current portion 7,386 7,493
Deferred revenue, less current portion 1,554 1,750 Other long-term
liabilities 7,786 2,973 Total liabilities 40,060 44,715
Stockholders' equity: Common stock 55 54 Additional paid-in capital
528,694 518,275 Deferred stock compensation (235) (454) Accumulated
other comprehensive income 19,962 22,632 Accumulated deficit
(389,779) (326,724) Total stockholders' equity 158,697 213,783
Total liabilities and stockholders' equity $198,757 $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, +1-212-923-6737, or , for
Vicuron Pharmaceuticals Inc.; or Aline Schimmel of Burns McClellan
Inc., +1-212-213-0006, or , for Vicuron Pharmaceuticals Inc. Web
site: http://www.vicuron.com/
Copyright