Bioenvision (NASDAQ:BIVN)
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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% 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 51.0%.
"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.
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.
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.
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.
Bioenvision disclaims any obligation to update these forward-looking
statements.
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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
=========== =========== =========== ===========
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