Vicuron (NASDAQ:MICU)
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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/