Vicuron Pharmaceuticals Announces First Quarter 2004 Financial Results
May 06 2004 - 4:45PM
PR Newswire (US)
Vicuron Pharmaceuticals Announces First Quarter 2004 Financial
Results KING OF PRUSSIA, Pa., May 6 /PRNewswire-FirstCall/ --
Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU)
today reported financial results for the three month period ended
March 31, 2004. Total revenues for the first quarter 2004 were $1.9
million compared with $1.8 million for 2003. Total operating
expenses were $26.1 million in the first quarter of 2004 compared
to $109.3 million during the same period last year. The operating
expenses in 2003 included a one-time non-cash write-off of acquired
in-process research and development (IP R&D) of $94.5 million
resulting from the completion of the merger of Versicor and
Biosearch Italia. For the first quarter of 2004, Vicuron reported a
net loss of $23.5 million or $0.44 per share on 54 million weighted
average shares outstanding. This compares to a net loss of $107.2
million, or $3.15 per share on 34 million weighted average shares
outstanding, for the first quarter of 2003. At March 31, 2004, cash
and cash equivalents and unrestricted marketable securities totaled
approximately $142.3 million. "Over the last few months, Vicuron
has made key appointments in sales and marketing to prepare us for
the launch of our novel antifungal agent, anidulafungin, an event
that we expect will mark the company's transition into a commercial
organization," said George F. Horner III, Vicuron's President and
Chief Executive Officer. "We also moved once-weekly dalbavancin
closer to an NDA filing by making steady progress in our ongoing
Phase III studies; we expect to report these data in the second
half of 2004." Recent Corporate and Product Highlights -- Announced
positive anidulafungin and dalbavancin data at the European
Congress of Clinical Microbiology and Infectious Diseases in
Prague, including in vitro data demonstrating anidulafungin's
superior potency against a broad range of Candida species and
clinical data demonstrating that anidulafungin is well-tolerated in
combination with voriconazole; -- Appointed experienced management
to drive anidulafungin market launch including Robert Radie as
Senior Vice President of Sales and Jennifer Copeland and Steven
Gelone as Directors of Medical Science Liaisons (MSL) -- the Sales
and MSL teams will work together in the field to help drive the
rapid uptake of anidulafungin; -- Announced positive Phase III data
demonstrating that anidulafungin can be safely used in combination
with liposomal amphotericin B without increasing side effects; and
-- Announced positive Phase II data showing once-weekly dalbavancin
has superior efficacy to vancomycin for catheter-related
bloodstream infections, marking the first time any Gram-positive
injectable antibiotic was shown to be superior to standard of care
in a head-to- head comparison for these types of infections. About
Vicuron Vicuron Pharmaceuticals is a biopharmaceutical company
focused on discovering, developing, manufacturing and
commercializing vital medicine for seriously ill patients in North
America and major countries in Europe. The company has filed a New
Drug Application with the U.S. Food and Drug Administration for its
lead product, anidulafungin, a novel antifungal agent. The
company's other lead product, dalbavancin, a novel intravenous
antibiotic for the treatment of serious Gram-positive infections,
is in Phase III 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, that the
timing of the filing of any new drug application might be delayed,
that subsequent clinical trials might indicate that a product
candidate is unsafe or ineffective, that any filed new drug
application may not be approved, that ongoing proprietary and
collaborative research might not occur or yield useful results,
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 their products or market
them more effectively, that a sales force may not be developed as
contemplated and that one or more of its 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 March 31, March 31, 2004 2003 Revenues: Collaborative
research and development and contract services $1,792 $1,717
License fees and milestones 136 41 Total revenues 1,928 1,758
Operating expenses: Research and development 22,035 12,723 General
and administrative 4,071 2,082 Acquired in-process research and
development -- 94,532 Total operating expenses 26,106 109,337 Loss
from operations (24,178) (107,579) Other income (expense): Interest
income 686 449 Interest expense (28) (70) Net loss $(23,520)
$(107,200) Net loss per share: Basic and diluted $(0.44) $(3.15)
Weighted average shares 54,029 33,995 CONDENSED CONSOLIDATED
BALANCE SHEETS (unaudited) (in thousands) March 31, December 31,
2004 2003 ASSETS Current assets: Cash and cash equivalents $102,176
$113,361 Marketable securities 40,170 52,796 Accounts receivable,
net 4,905 5,533 Prepaid expenses and other current assets 6,964
6,329 Total current assets 154,215 178,019 Property, plant and
equipment 45,389 43,757 Intangible assets, net 22,201 23,373
Long-term receivables 11,075 9,787 Long-term marketable
securities-restricted 125 3,232 Other assets 3,156 330 Total assets
$236,161 $258,498 LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable $14,035 $13,986 Accrued liabilities
18,436 15,085 Current portion of long term debt 1,785 2,360 Current
portion of deferred revenue 911 1,068 Total current liabilities
35,167 32,499 Long-term debt, less current portion 7,311 7,493
Deferred revenue, less current portion 1,750 1,750 Other long-term
liabilities 2,985 2,973 Total liabilities 47,213 44,715
Stockholders' equity: Common stock 54 54 Additional paid-in capital
520,899 518,275 Deferred stock compensation (473) (454) Accumulated
other comprehensive income 18,712 22,631 Accumulated deficit
(350,244) (326,723) Total stockholders' equity 188,948 213,783
Total liabilities and stockholders' equity $236,161 $258,498
DATASOURCE: Vicuron Pharmaceuticals, Inc. CONTACT: Dov A.
Goldstein, M.D. of Vicuron Pharmaceuticals Inc., +1-610-205-2312,
or , or Hala Bashir of WeissCom Partners, +1-212-204-2080, or , or
E. Blair Schoeb of Burns McClellan Inc., +1-212-213-0006, or , both
for Vicuron Pharmaceuticals, Inc. Web site: http://www.vicuron.com/
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