Please replace the release with the following corrected version due
to multiple revisions (a financial table and note were inserted and
two bullet points after the first graf were corrected). The
corrected release reads: BIOENVISION REPORTS SECOND QUARTER 2006
FINANCIAL RESULTS Bioenvision (NASDAQ NM: BIVN) today announced
financial results for the second quarter ended December 31, 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 marketing authorization application for approval
of clofarabine in pediatric patients with ALL; -- Bioenvision
provided written responses to the final list of outstanding issues
presented by the EMeA; -- Revenues decreased 7.2% from $1,176,000
for the three months ended December 31, 2004 to $1,091,000 for the
three months ended December 31, 2005; and -- Revenues do not
include $685,000 in amounts invoiced to Genzyme Corporation for the
three months ended December 31, 2005, but not yet paid under the
Co-Development Agreement. "We continue to make progress developing
our product portfolio including clofarabine, which is at market in
the U.S. 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
mid-2006 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 December 31, 2005 and 2004, Bioenvision recorded
revenues of $1,091,000 and $1,176,000, respectively. This decrease
of 7.2% is due to a decrease in R&D contract revenue of
$359,000 and product sales of $41,000, offset by an increase in
license and royalty revenue of $316,000. 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 44.5% as compared with
R&D contract revenues recorded for the three months ended
December 31, 2004 (see reconciliation table and note below). For
the six months ended December 31, 2005 and 2004, Bioenvision
recorded revenues of $1,762,000 and $2,261,000, respectively. This
decrease of 22.1% is due to a decrease in R&D contract revenue
of $1,016,000, offset by an increase in license and royalty revenue
of $362,000 and product sales of $154,000. The decrease in R&D
contract revenue is due to the Company's exclusion of approximately
$1,371,000 of amounts invoiced to Genzyme Corporation during the
six months but not recorded as revenues. R&D contract revenues
for the six months adjusted for such amounts invoiced for
clofarabine R&D reimbursements increased 24.3% as compared with
R&D contract revenues recorded for the six months ended
December 31, 2004 (see reconciliation table and note below).
SG&A expenses for the three months ended December 31, 2005 and
2004 were approximately $2,582,000 and $3,054,000, respectively.
This decrease of 15.5% is due to a decrease in consulting expense
relating to the vesting of warrants during the three months ended
December 31, 2004. This was offset by 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. SG&A
expenses for the six months ended December 31, 2005 and 2004 were
approximately $5,470,000 and $4,811,000, respectively. This
increase of 13.7% is due both to an increase in costs associated
with sales and marketing due to the expansion of regulatory and
investor relations activities and an increase in head count in both
the New York and Edinburgh offices, partially offset by a decrease
in consulting expense relating to the vesting of warrants during
the six months ended December 31, 2004. Research and development
costs for the three months ended December 31, 2005 and 2004 were
$2,011,000, compared with $1,689,000, respectively. This increase
of 19.1% 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. Research and development costs for the six months
ended December 31, 2005 and 2004 were $4,442,000 and $3,828,000,
respectively. This increase of 16.0% is due to costs primarily
associated with the increased clofarabine development activities
and ongoing clinical trials for pediatric acute leukemia and adult
acute myeloid leukemia in Europe. Net loss available to
shareholders was $3,879,000, or $0.10 per share for the three
months ended December 31, 2005, compared with net loss available to
shareholders of $4,115,000, or $0.14 per share for the three months
ended December 31, 2004. Net loss available to shareholders was
$8,769,000, or $0.22 per share for the six months ended December
31, 2005, compared with net loss available to shareholders of
$7,336,000, or $0.25 per share for the six months ended December
31, 2004. Bioenvision had cash and cash equivalents and short-term
investments at December 31, 2005 of $54.0 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. -0- *T
Reconciliation of Non-U.S. GAAP Financial Measure Adjusted total
revenue defined as total revenue plus amounts invoiced for Genzyme
clofarabine reimbursements Three months Six months ended ended
December 31, 2005 Total revenue, as reported $1,091,307 $1,761,525
Amounts invoiced for Genzyme clofarabine reimbursements 684,534
1,371,019 ---------------------------- Adjusted revenue $1,775,841
$3,132,544 NOTE: Adjusted revenue, defined as total revenue plus
amounts invoiced for Genzyme clofarabine reimbursements, is a
non-U.S. GAAP measure used by management in evaluating the
performance of the company's overall business. The company believes
that this performance measure contributes to a more complete
understanding by investors of the overall results of the company
because the amounts invoiced for Genzyme clofarabine reimbursements
were included in the results of operations for the three and six
months ended December 31, 2004. Adjusted R&D contract revenue
defined as R&D contract revenue plus amounts invoiced for
Genzyme clofarabine reimbursements Three months Six months ended
ended December 31, 2005 R&D contract revenue, as reported
$373,408 $448,500 Amounts invoiced for Genzyme clofarabine
reimbursements 684,534 1,371,019 ----------------------------
Adjusted R&D contract revenue $1,057,942 $1,819,519 NOTE:
Adjusted R&D contract revenue, defined as R&D contract
revenue plus amounts invoiced for Genzyme clofarabine
reimbursements, is a non-U.S. GAAP measure used by management in
evaluating the performance of the company's overall business. The
company believes that this performance measure contributes to a
more complete understanding by investors of the overall results of
the company because the amounts invoiced for Genzyme clofarabine
reimbursements were included in the results of operations for the
three and six months ended December 31, 2004. *T Conference Call
Bioenvision management will host a conference call to discuss these
results today at 11:00 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 1:00 p.m. EST February 14th until
11:59 p.m. EST February 28th by dialing 877-519-4471 or
973-341-3080 and entering reservation number 6940032. 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 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. Further, no assurance can be given that the amounts
invoiced to Genzyme not recorded as revenues will be paid to
Bioenvision by Genzyme. Bioenvision disclaims any obligation to
update these forward-looking statements. -0- *T BIOENVISION, INC.
AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (unaudited) December
31, June 30, 2005 2005 ------------ ------------ ASSETS Current
assets Cash and cash equivalents $ 3,010,401 $ 31,407,533
Restricted cash - 290,000 Short-term securities 51,010,728
32,746,948 Accounts receivable, less allowances of $897,161 and
$869,220, at December 31, 2005 and June 30, 2005, respectively
1,523,281 1,785,779 Inventory 400,076 277,908 Other current assets
628,494 342,628 ------------ ------------ Total current assets
56,572,980 66,850,796 Property and equipment, net 285,359 279,778
Intangible assets, net 7,984,397 8,252,936 Goodwill 1,540,162
1,540,162 Security deposits 207,271 209,665 Deferred costs
3,541,213 3,656,798 ------------ ------------ Total assets $
70,131,382 $ 80,790,135 ============ ============ LIABILITIES AND
STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 863,148
$ 1,602,267 Accrued expenses 3,139,778 4,581,444 Accrued dividends
payable 57,329 56,404 Deferred revenue 498,607 498,607 ------------
------------ Total current liabilities 4,558,862 6,738,722 Deferred
revenue 7,188,292 7,437,598 ------------ ------------ Total
liabilities 11,747,154 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 December 31, 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; 40,767,743 and
40,558,948 shares issued and outstanding at December 31, 2005 and
June 30, 2005, respectively 40,768 40,559 Additional paid-in
capital 129,779,181 128,946,717 Deferred compensation - (145,646)
Accumulated deficit (71,099,596) (62,331,005) Shareholder
receivable (340,606) - Accumulated other comprehensive income 2,231
100,940 ------------ ------------ Stockholders' equity 58,384,228
66,613,815 ------------ ------------ Total liabilities and
stockholders' equity $ 70,131,382 $ 80,790,135 ============
============ BIOENVISION, INC. AND SUBSIDIARIES CONSOLIDATED
STATEMENTS OF OPERATIONS (unaudited) Three months ended Six months
ended December 31, December 31, 2005 2004 2005 2004 (Restated
(Restated - Note I) - Note I) Revenue Licensing and royalty revenue
$ 543,919 $ 228,400 $ 944,049 $ 581,657 Product sales 173,980
215,131 368,976 215,131 Research and development contract revenue
373,408 732,392 448,500 1,464,463 ----------- -----------
----------- ----------- Total revenue 1,091,307 1,175,923 1,761,525
2,261,251 Costs and expenses Cost of products sold, including
royalty expense of $331,000 and $22,000 for the three months ended
December 31, 2005 and 2004, respectively and $532,000 and $22,000
for the six months ended December 31, 2005 and 2004, respectively.
438,018 152,359 766,309 152,359 Research and development 2,011,263
1,688,747 4,442,181 3,827,644 Selling, general and administrative
2,582,191 3,054,239 5,469,653 4,810,952 Depreciation and
amortization 256,872 341,987 481,155 681,693 -----------
----------- ----------- ----------- Total costs and expenses
5,288,344 5,237,332 11,159,298 9,472,648 ----------- -----------
----------- ----------- Loss from operations (4,197,037)
(4,061,409) (9,397,773) (7,211,397) Interest and finance charges -
- (66,761) - Interest income 403,175 56,578 866,080 112,014
----------- ----------- ----------- ----------- Net loss
(3,793,862) (4,004,831) (8,598,454) (7,099,383) Cumulative
preferred stock dividend (85,069) (110,375) (170,137) (236,716)
----------- ----------- ----------- ----------- Net loss available
to common stockholders $(3,878,931)$(4,115,206)
$(8,768,591)$(7,336,099) =========== =========== ===========
=========== Basic and diluted net loss per share of common stock $
(0.10)$ (0.14) $ (0.22)$ (0.25) =========== =========== ===========
=========== Weighted average shares used in computing basic and
diluted net loss per share 40,762,508 29,728,769 40,761,636
29,122,609 =========== =========== =========== =========== *T
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