Bioenvision (NASDAQ NM:BIVN) today announced financial results for
the first quarter ended September 30, 2005. Highlights of the
quarter include: -- Patient enrollment completed in a Phase II
regulatory trial of clofarabine for treatment of elderly patients
with adult AML who are deemed unfit for intensive chemotherapy; --
EMeA provided a final list of outstanding issues regarding pending
application for approval of clofarabine in pediatric patients with
ALL; -- Revenues decreased 38.2% based on discontinued recordation
of revenues from Genzyme Corporation; and -- Revenues, as adjusted
for amounts invoiced to Genzyme not recorded as revenues for the
quarter, increased 24.9%. "We continue to make progress developing
our product portfolio including clofarabine, which is at market in
the US and under review for marketing authorization in Europe, and
Virostat, which may well play significantly in terms of value
drivers for the Company in the future," commented Christopher B.
Wood, M.D., chairman and chief executive officer of Bioenvision.
"We have submitted a Marketing Authorization Application, the
European equivalent of a U.S. New Drug Application, with the
European Medicines Evaluation Agency (EMeA) for European approval
of clofarabine in relapsed or refractory pediatric acute leukemia."
Dr. Wood continued, "We hope to continue the clofarabine
development process with a filing for approval with the EMeA in
H1C06 in elderly patients with AML who are unfit for intensive
chemotherapy. In addition to these approved cancer therapeutics,
the Company has completed enrollment of a Phase II clinical trial
with Virostat for the treatment of Hepatitis C." For the three
months ended September 30, 2005 and 2004, Bioenvision recorded
revenues of $670,000 and $1.1 million, respectively. This decrease
of 38.2% is due to a decrease in R&D contract revenue of
$657,000 offset by an increase in product sales of $195,000 and
license and royalty revenue of $47,000. The decrease in R&D
contract revenue is due to the Company's exclusion of approximately
$685,000 of amounts invoiced to Genzyme Corporation during the
quarter but not recorded as revenues. R&D contract revenues
during the quarter adjusted for such amounts invoiced for
clofarabine R&D reimbursements increased 24.9% as compared with
R&D contract revenues recorded for the three-months ended
September 30, 2004. SG&A expenses for the three months ended
September 30, 2005 and 2004 were approximately $2.9 million and
$1.8 million, respectively. This increase of 64.4% is due both to
an increase in costs associated with sales and marketing costs due
to the expansion of regulatory and investor relations initiatives
and an increase in head count in both the New York and Edinburgh
offices. Research and development costs for the three months ended
September 30, 2005 and 2004 were $2.4 million, compared with $2.1
million, respectively. This increase of 13.7% is due to costs
primarily associated with the increased development activities and
ongoing clinical trials for clofarabine for pediatric leukemia in
Europe, adult AML (Acute Myeloid Leukemia) and Virostat for
ongoing, multi-center investigator sponsored Phase II clinical
trials being conducted in Egypt and Southern Europe. Net loss
available to shareholders was $4.9 million, or $0.12 per share for
the three months ended September 30, 2005, compared with net loss
available to shareholders of $3.2 million, or $0.11 per share for
the three months ended September 30, 2004. Bioenvision had cash and
cash equivalents and short-term investments at September 30, 2005
of $60.4 compared with $64.1 million at June 30, 2005. The decrease
in the cash position is due to the cash burn associated with
clinical trials for clofarabine and virostat as well as general
administrative costs. Conference Call Bioenvision management will
host a conference call to discuss these results today at 8:00 a.m.
EST. To participate in the live call by telephone, please dial
877-825-5811 from the U.S. and Canada or 973-582-2767 from outside
the U.S. A telephone replay of the call will be available beginning
at 10:00 a.m. EST November 14 until 11:59 p.m. EST November 28th by
dialing 877-519-4471 or 973-341-3080 and entering reservation
number 6701150. Those interested in listening to the conference
call live via the Internet may do so by visiting Bioenvision's web
site at www.bioenvision.com. To listen to the live call, please go
to the web site 15 minutes prior to its start to register,
download, and install the necessary audio software. A replay will
be available on the web site for 14 days. About Bioenvision
Bioenvision's primary focus is the acquisition, development and
distribution of compounds and technologies for the treatment of
cancer. Bioenvision has a broad pipeline of products for the
treatment of cancer, including: Clofarabine (in co-development with
Genzyme Corporation), Modrenal(R) (for which Bioenvision has
obtained regulatory approval for marketing in the United Kingdom
for the treatment of post-menopausal breast cancer following
relapse to initial hormone therapy), and other products in clinical
trials. Bioenvision is also developing anti-infective technologies,
including Virostat for hepatitis-C and the OLIGON technology; an
advanced biomaterial that has been incorporated into various FDA
approved medical devices. For more information on Bioenvision
please visit our web site at www.bioenvision.com. Certain
statements contained herein are "forward-looking" statements (as
such term is defined in the Private Securities Litigation Reform
Act of 1995). Because these statements include risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements.
Specifically, factors that could cause actual results to differ
materially from those expressed or implied by such forward-looking
statements include, but are not limited to: risks associated with
preclinical and clinical developments in the biopharmaceutical
industry in general and in Bioenvision's compounds under
development in particular; the potential failure of Bioenvision's
compounds under development to prove safe and effective for
treatment of disease; uncertainties inherent in the early stage of
Bioenvision's compounds under development; failure to successfully
implement or complete clinical trials; failure to receive marketing
clearance from regulatory agencies for our compounds under
development; acquisitions, divestitures, mergers, licenses or
strategic initiatives that change Bioenvision's business, structure
or projections; the development of competing products;
uncertainties related to Bioenvision's dependence on third parties
and partners; and those risks described in Bioenvision's filings
with the SEC. Bioenvision disclaims any obligation to update these
forward-looking statements. -0- *T Bioenvision, Inc. and
Subsidiaries CONSOLIDATED BALANCE SHEETS (unaudited) September 30,
June 30, 2005 2005 ------------ ----------- ASSETS Current assets
Cash and cash equivalents $ 12,208,760 $ 31,407,533 Restricted cash
290,000 290,000 Short-term securities 48,209,088 32,746,948
Accounts receivable, less allowances of $869,220 and $869,220,
respectively 1,403,542 1,785,779 Inventory 361,741 277,908 Other
current assets 781,060 342,628 ------------ ------------ Total
current assets 63,254,191 66,850,796 Property and equipment, net
290,068 279,778 Intangible assets, net 8,155,836 8,252,936 Goodwill
1,540,162 1,540,162 Security deposits 208,475 209,665 Deferred
costs 3,599,006 3,656,798 ------------ ------------ Total assets $
77,047,738 $ 80,790,135 ============ ============ LIABILITIES AND
STOCKHOLDERS' EQUITY Current liabilities Accounts payable $
1,755,461 $ 1,602,267 Accrued expenses 5,266,932 4,581,444 Accrued
dividends payable 57,329 56,404 Deferred revenue 498,607 498,607
------------ ------------ Total current liabilities 7,578,329
6,738,722 Deferred revenue 7,312,945 7,437,598 ------------
------------ Total liabilities 14,891,274 14,176,320 Commitments
and contingencies - - Stockholders' equity Convertible preferred
stock - $0.001 par value; 20,000,000 shares authorized; 2,250,000
shares issued and outstanding on each of September 30, 2005 and
June 30, 2005 (liquidation preference $6,750,000) 2,250 2,250
Common stock - par value $0.001; 70,000,000 shares authorized;
40,760,763 and 40,448,948 shares issued and outstanding at
September 30, 2005 and June 30, 2005, respectively 40,761 40,559
Additional paid-in capital 129,282,618 128,946,717 Deferred
compensation - (145,646) Accumulated deficit (67,220,665)
(62,331,005) Accumulated other comprehensive income 51,500 100,940
------------ ------------ Stockholders' equity 62,156,464
66,613,815 ------------ ------------ Total liabilities and
stockholders' equity $ 77,047,738 $ 80,790,135 ============
============ Bioenvision, Inc. and Subsidiaries CONSOLIDATED
STATEMENTS OF OPERATIONS (unaudited) Three months ended September
30, 2005 2004 ----------- ----------- (Restated) Revenue Licensing
and royalty revenue $ 400,130 $ 363,182 Product sales 194,996 -
Research and development contract revenue 75,092 722,146
----------- ----------- Total revenue 670,218 1,085,328 Costs and
expenses Cost of products sold (including royalty expense of
$201,000 for the three months ending September 30, 2005) 328,291 -
Research and development 2,430,918 2,138,897 Selling, general and
administrative (including stock based compensation expense of
$482,000 and $391,000 for the three months ending September 30,
2005 and 2004, respectively) 2,887,462 1,756,713 Depreciation and
amortization 224,283 339,706 ----------- ----------- Total costs
and expenses 5,870,954 4,235,316 ----------- ----------- Loss from
operations (5,200,736) (3,149,988) Interest and finance charges
(66,761) - Interest income 462,905 55,437 ----------- -----------
Net loss (4,804,592) (3,094,551) Cumulative preferred stock
dividend (85,068) (126,341) ----------- ----------- Net loss
available to common stockholders $(4,889,660)$(3,220,892)
=========== =========== Basic and diluted net loss per share of
common stock $(0.12) $(0.11) ======= ======= Weighted average
shares used in computing basic and diluted net loss per share
40,572,626 28,516,450 =========== =========== *T
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