Bioenvision (NASDAQ:BIVN) today announced financial results for the
third quarter ended March 31, 2006. Highlights of the quarter
include: -- EMeA's Committee for Human Medicinal Products (CHMP)
provides a positive opinion for the use of Evoltra(R) for the
treatment of acute lymphoblastic leukemia in pediatric patients who
have relapsed or are refractory to at least two prior regimens; --
Patient enrollment completed in a Phase II regulatory trial of
Evoltra(R) (clofarabine) for treatment of elderly patients with
adult AML who are deemed unfit for intensive chemotherapy; --
Revenues for the quarter ended March 31, 2006 increased 24.5% to
$1.7 million, up from $1.4 million for the quarter ended March 31,
2005; -- Net loss applicable to common shareholders for the quarter
ended March 31, 2006 increased $0.12 per share to $0.20 per share,
up from $0.08 per share for the quarter ended March 31, 2005; --
Net loss applicable to common shareholders adjusted to exclude
employee stock-based compensation recorded for the quarters ended
March 31, 2006 and 2005 increased $0.05 per share to $0.15 per
share for the quarter ended March 31, 2006, up from $0.10 per share
for the quarter ended March 31, 2005. (Refer to our reconciliation
table of GAAP net loss applicable to common shareholders to the
adjusted net loss available to common shareholders). "We continue
to make progress developing our product portfolio, with Evoltra(R)
(clofarabine), Modrenal(R) and Suvus(R), which may become
significant value drivers for the company in the future," commented
Christopher B. Wood, M.D., Chairman and Chief Executive Officer of
Bioenvision. "We are delighted especially with the CHMP Positive
Opinion in the EU's centralized process and look forward to our
European marketing launch of Evoltra(R) in the near future." Dr.
Wood continued, "We hope to continue the Evoltra(R) development
process with a filing for approval with the EMeA in H2 2006 in
elderly patients with AML who are unfit for intensive chemotherapy.
In addition, the Company has completed enrollment of a Phase II
clinical trial with Suvus(R) for the treatment of Hepatitis C and
is continuing its development strategy with this product in 2006."
The Company recorded revenues for the three months ended March 31,
2006 and 2005 of approximately $1,741,000 and $1,399,000,
respectively, representing an increase of approximately $342,000 or
24.5%. This increase was primarily due to an increase in Named
Patient Program reimbursements and certain research and development
reimbursements in the amount of $863,000, partially offset by a
decrease of $567,000 in research and development contract revenue
which the Company did not record as revenue in the three-month
period ended March 31, 2006. The Company recorded revenues for the
nine months ended March 31, 2006 and 2005 of approximately
$3,503,000 and $3,660,000, respectively, representing a decrease of
approximately $157,000 or 4.3%. This decrease was primarily due to
a decrease in research and development contract revenue as the
Company did not record revenues for the three and nine months ended
March 31, 2006, respectively, relating to the reimbursement from
our co-development partner for certain of our ongoing research
costs in the development of Evoltra(R) outside the United States
because it determined that the criteria for recognizing such
contract revenues had not been met. This decrease is substantially
offset by an increase in named patient sales of clofarabine.
Selling, general and administrative expenses for the three months
ended March 31, 2006 and 2005 were approximately $6,914,000 and
$1,894,000, respectively, representing an increase of $5,020,000 or
265.1%. Approximately 52% of this increase is a non-cash expense
and is due to the Company recognizing stock-based compensation
expense for options granted to employees due to the adoption of
SFAS 123(R) on July 1, 2005. Secondary factors contributing to this
increase include an increase in costs associated with the expanded
sales and marketing and administrative infrastructure and costs
associated with the internal build out of the Company. For the
three months ended March 31, 2006, the Company recorded employee
stock-based compensation expense of approximately $1,949,000 as a
selling, general and administrative expense, whereas for the same
period in the prior year, the Company recorded employee stock-based
compensation income of approximately $650,000, relating to the
re-measuring of the intrinsic value of stock options. Selling,
general and administrative expenses for the nine months ended March
31, 2006 and 2005 were approximately $12,383,000 and $6,680,000,
respectively, representing an increase of $5,703,000 or 85.4%.
Approximately 58% of this increase is a non-cash expense and is due
to the Company recognizing stock-based compensation expense for the
options granted to employees due to the adoption of SFAS 123(R) on
July 1, 2005. Secondary factors contributing to this increase
include an increase in costs associated with the expanded sales and
marketing and administrative infrastructure and costs associated
with the internal build out of the Company. For the nine months
ended March 31, 2006, the Company has recorded $2,851,000 in
employee stock-based compensation expense, whereas the Company
recorded employee stock-based compensation income of approximately
$431,000, relating to the re-measuring of the intrinsic value of
stock options for the same period in the prior year. Research and
development costs for the three months ended March 31, 2006 and
2005 were approximately $2,785,000 and $2,137,000, respectively,
representing an increase of approximately $648,000 or 30.3%. The
increase primarily reflects costs which are associated with our
increased development activities and clinical trials of Evoltra(R)
being conducted in Europe (which includes the filing process for EU
approval). Research and development costs for the nine months ended
March 31, 2006 and 2005 were approximately $7,227,000 and
$5,986,000, respectively, representing an increase of approximately
$1,241,000 or 20.7%. The increase primarily reflects costs which
are associated with our increased development activities and
clinical trials of Evoltra(R) being conducted in Europe (which
includes the filing process for EU approval) along with our
Modrenal(R) Phase II clinical trial in pre-menopausal cancer and
Phase IV clinical trial in patients with post-menopausal cancer,
which are each being conducted in the U.K. and with the
investigator sponsored Phase II clinical trial conducted in Egypt
for Suvus(R) and costs associated with the preparation of an IND
application to be filed with the FDA. Net loss applicable to common
shareholders was $8,222,000, or $0.20 per share for the three
months ended March 31, 2006, compared with net loss applicable to
common shareholders of $3,156,000, or $0.08 per share for the three
months ended March 31, 2005. Net loss applicable to common
shareholders was $16,990,000, or $0.42 per share for the nine
months ended March 31, 2006, compared with net loss applicable to
common shareholders of $10,492,000, or $0.33 per share for the nine
months ended March 31, 2005. Due to the adoption of SFAS 123(R),
the Company expects to record additional employee stock-based
compensation expense for the fiscal year ended June 30, 2006. This
non-cash expense does not impact our cash flows from our
operations, which currently consists of cash outflows associated
with bringing our lead drug, Evoltra(R), to market as well general
and administrative costs. The Company had cash and cash equivalents
and short-term investments at March 31, 2006 of $49,812,000
compared with $64,154,000 million at June 30, 2005. The decrease in
the cash position is due to the cash burn associated with clinical
trials for Evoltra(R) and Suvus(R), marketing costs associated with
the launch of Evoltra(R) and general administrative costs.
Reconciliation of Non-US GAAP Financial Measure Adjusted net loss
applicable to common shareholders defined as net loss applicable to
common shareholders less employee stock-based compensation recorded
for the three and nine months ended March 31, 2006 and 2005,
respectively. -0- *T Three months ended Nine months ended March 31,
March 31, 2006 2005 2006 2005 ----------- ----------- -----------
------------- Net loss available to common shareholders, as
reported $(8,221,521)$(3,155,629)$(16,990,110)$(10,491,728) Add:
Employee stock- based compensation expense (income) recorded
2,057,566 (628,508) 2,998,506 (365,016)
-------------------------------------------------- Adjusted net
loss available to common shareholders
$(6,163,955)$(3,784,137)$(13,991,604)$(10,856,744) ===========
=========== ============ ============ Basic and diluted net loss
per share of common stock, as reported $(0.20) $(0.08) $(0.42)
$(0.33) Adjusted basic and diluted net loss per share of common
stock $(0.15) $(0.10) $(0.34) $(0.34) Weighted-average shares used
in computing basic & diluted net loss per share 40,870,688
37,602,163 40,734,286 31,907,864 *T Conference Call Bioenvision
management will host a conference call to discuss these results
today at 10:00 a.m. EST. To participate in the live call by
telephone, please dial 877-715-5320 from the U.S. and Canada or
973-582-2853 from outside the U.S. A telephone replay of the call
will be available beginning at 12:00 p.m. EST May 15th until 11:59
p.m. EST May 29th by dialing 877-519-4471 or 973-341-3080 and
entering reservation number 7373873. Those interested in listening
to the conference call live via the Internet may do so by visiting
www.vcall.com where a link to Bioenvision's conference call can be
found. 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 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, 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. -0- *T
BIOENVISION, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE
SHEETS March 31, June 30, 2006 2005 ASSETS Current assets Cash and
cash equivalents $ 8,594,245 $ 31,407,533 Restricted cash - 290,000
Short-term securities 41,217,264 32,746,948 Accounts receivable,
less allowances of $897,472 and $869,220 at March 31, 2006 and June
30, 2005, respectively 2,454,289 1,785,779 Inventories 352,315
277,908 Other current assets 603,725 342,628 -------------
------------- Total current assets 53,221,838 66,850,796 Property
and equipment, net 284,748 279,778 Intangible assets, net 7,768,929
8,252,936 Goodwill 1,540,162 1,540,162 Security deposits 207,818
209,665 Deferred costs 3,483,421 3,656,798 -------------
------------- Total assets $ 66,506,916 $ 80,790,135 =============
============= LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities Accounts payable $ 1,095,592 $ 1,602,267 Accrued
expenses 5,194,524 4,581,444 Accrued dividends payable 55,479
56,404 Deferred revenue 498,607 498,607 ------------- -------------
Total current liabilities 6,844,202 6,738,722 Deferred revenue
7,063,639 7,437,598 ------------- ------------- Total liabilities
13,907,841 14,176,320 Commitments and contingencies - -
Stockholders' equity Convertible preferred stock - $0.001 par
value; 20,000,000 shares authorized; 2,250 2,250 2,250,000 shares
issued and outstanding at March 31, 2006 and June 30, 2005
(liquidation preference $6,750,000) Common stock - par value
$0.001; 70,000,000 shares authorized; 41,004 40,559 41,003,847 and
40,558,948 shares issued and outstanding at March 31, 2006 and June
30, 2005, respectively Additional paid-in capital 132,235,677
128,946,717 Deferred compensation - (145,646) Accumulated deficit
(79,321,115) (62,331,005) Shareholder receivable (340,606) -
Accumulated other comprehensive (loss) income (18,135) 100,940
------------- ------------- Total stockholders' equity 52,599,075
66,613,815 ------------- ------------- Total liabilities and
stockholders' equity $ 66,506,916 $ 80,790,135 =============
============= BIOENVISION, INC. AND SUBSIDIARIES CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three months
ended Nine months ended March 31, March 31, 2006 2005 2006 2005
Revenue Licensing and royalty revenue $ 502,584 $ 430,411 $
1,446,633 $ 1,012,068 Product sales 124,029 149,364 493,005 364,495
Research and development contract revenue 1,114,482 819,194
1,562,982 2,283,657 ----------- ----------- ------------
------------ Total revenue 1,741,095 1,398,969 3,502,620 3,660,220
Costs and expenses Cost of products sold, including royalty expense
of $316,000 and $181,000 for the three months ended March 31, 2006
and 2005, respectively and $847,000 and $205,000 for the nine
months ended March 31, 2006 and 2005, respectively 386,818 279,596
1 ,153,127 434,394 Research and development 2,785,004 2,136,849
7,227,185 5,986,496 Selling, general and administrative 6,913,698
1,893,895 12,383,350 6,680,405 Depreciation and amortization
247,365 346,504 728,520 1,028,197 ----------- -----------
------------ ------------ Total costs and expenses 10,332,885
4,656,844 21,492,182 14,129,492 ----------- -----------
------------ ------------ Loss from operations (8,591,790)
(3,257,875) (17,989,562) (10,469,272) Interest and finance charges
- - (66,761) - Interest income 453,488 185,465 1,319,568 297,479
----------- ----------- ------------ ------------ Net loss
(8,138,302) (3,072,410) (16,736,755) (10,171,793) Preferred stock
dividend (83,219) (83,219) (253,355) (319,935) -----------
----------- ------------ ------------ Net loss applicable to common
stockholders $(8,221,521)$(3,155,629)$(16,990,110)$(10,491,728)
=========== =========== ============ ============ Basic and diluted
net loss per share of common stock $ (0.20)$ (0.08)$ (0.42)$ (0.33)
=========== =========== ============ ============ Weighted average
shares used in computing basic and diluted net loss per share
40,870,688 37,602,163 40,734,286 31,907,864 =========== ===========
============ ============ *T
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