Bioenvision (NASDAQ:BIVN)
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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.
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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
=========== ===========
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