Bioenvision (NASDAQ:BIVN)
Historical Stock Chart
From Jul 2019 to Jul 2024
![Click Here for more Bioenvision Charts. Click Here for more Bioenvision Charts.](/p.php?pid=staticchart&s=N%5EBIVN&p=8&t=15)
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