Bioenvision (NASDAQ:BIVN)
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Bioenvision (NasdaqGM:BIVN) today announced financial results for
the first quarter ended September 30, 2006. Highlights of the quarter
include:
Bioenvision successfully conducted its Evoltra®
(clofarabine) marketing launch at SIOP conference in September 2006;
Bioenvision entered into a licensing agreement to acquire Evoltra®
marketing rights in Japan and Southeast Asia;
Bioenvision records $2.9 million of revenue for the quarter; up from
$670,000 in the quarter ended September 30, 2005;
Bioenvision appoints Vice President, Regulatory Affairs.
“We continue to make strong progress in terms
of Evoltra® marketing and development
activities and in the build out of our infrastructure,”
commented David P. Luci, Chief Financial Officer and General Counsel of
Bioenvision.
“We will now focus our development efforts on
expanding Evoltra®’s
commercial potential,” said Dr. Christopher B.
Wood, Bioenvision’s Chairman and Chief
Executive Officer. “Our next target in
Evoltra development is the filing, before year’s
end, for approval with the European Commission to treat elderly patients
with AML who are unfit for intensive chemotherapy. Then we plan to
position Evoltra® into other hematology
indications, such as MDS and chronic leukemia,”
Dr. Wood added.
For the three months ended September 30, 2006 and 2005, Bioenvision
recorded revenues of $2,865,000 and $670,000, respectively. This
increase of 328% is due to an increase in product sales of Evoltra®
due to marketing approval received in Q4 of 2006 as well as an increase
in license and royalty revenue of $590,000.
Selling, General and Administrative expenses for the three months ended
September 30, 2006 and 2005 were approximately $5,469,000 and
$2,887,000, respectively. This increase of 89.4% is due to an increase
in sales and marketing costs associated with the marketing launch of
Evoltra® in September 2006. The Company also
experienced an increase in expenses of approximately $1,403,000 relating
to the build-up of a sales and marketing and administrative
infrastructure throughout Europe upon approval of Evoltra®
in May 2006. The Company also recognized an increase in the non-cash
charge of stock-based compensation of $223,000.
Research and development costs for the three months ended September 30,
2006 and 2005 were $9,270,000 and $2,431,000, respectively. This
increase of 281.3% is due to the Company licensing clofarabine in Japan
and Southeast Asia; a territory previously ungranted by clofarabine’s
inventor. The increase is also due to the increased development
activities and ongoing clinical trials of clofarabine for pediatric and
adult leukemias and psoriasis. Excluding the one-time costs associated
with our having licensed Evoltra® marketing
rights in Japan and Southeast Asia, we would have recorded R&D costs for
the three months ended September 30, 2006 and 2005 of $5,317,000 and
$2,431,000, respectively (see Non-GAAP reconciliation set forth below).
Net loss available to shareholders was $12,211,000, or $0.29 loss per
share for the three months ended September 30, 2006, compared with net
loss available to shareholders of $4,890,000, or $0.12 loss per share
for the three months ended September 30, 2005.
Bioenvision had cash and cash equivalents and short-term investments at
September 30, 2006 of $35,777,000 compared with $45,015,000 at June 30,
2006. The decrease in the cash position is due to the cash burn
associated with our licensing marketing rights to clofarabine in Japan
and Southeast Asia as well as ongoing clinical trials for clofarabine
and modrenal as well as general administrative costs associated with the
marketing launch of Evoltra® and the
implementation of a sales force within the EU.
Reconciliation of Non-US GAAP
Financial Measure
Adjusted net loss applicable to common stockholders defined as net loss
applicable to common shareholders less one-time expense for the Japanese
license agreement recorded for the quarters ended September 30, 2006 and
2005, respectively.
Quarter ended September 30,
2006
2005
Net loss applicable to common stockholders, as reported
$(12,210,762)
$(4,889,660)
Add: One-time charge for Japanese license agreement
3,953,074
-
Adjusted net loss applicable to common stockholders
$(8,257,688)
$(4,889,660)
Basic and diluted net loss per share of common stock, as reported
$(0.29)
$(0.12)
Adjusted basic and diluted net loss per share of common stock
$(0.20)
$(0.12)
Weighted-average shares used in computing basic & diluted net loss
per share
41,456,942
40,572,626
Conference Call
Conference Call Information:
Date: 11/9/06
Time: 12:00PM Eastern
Toll free (US & Canada): 866-585-6398
International: 416-849-9626
Web cast: www.bioenvision.com
A replay of the call and web cast will be available for 14 days.
Replay number (US & Canada): 866-245-6755
Replay number international: 416-915-1035
Replay passcode: 816197
Web cast replay: www.bioenvision.com
About Bioenvision
Bioenvision's primary focus is the acquisition, development,
distribution and marketing of compounds and technologies for the
treatment of cancer. Bioenvision has a broad pipeline of products for
the treatment of cancer, including: Evoltra®,
Modrenal® (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. Bioenvision is also developing
anti-infective technologies, including the OLIGON®
technology; an advanced biomaterial that has been incorporated into
various FDA approved medical devices and Suvus®,
an antimicrobial agent currently in clinical development for refractory
chronic hepatitis C infection. 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.
BIOENVISION, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30,
June 30,
2006
2006
ASSETS
(unaudited)
Current assets
Cash and cash equivalents
$
4,215,118
$
3,377,937
Short-term securities
31,562,264
41,637,106
Accounts receivable, less allowances of $899,000
3,233,091
2,369,446
Inventories
425,402
427,514
Other current assets
1,460,491
844,810
Total current assets
40,896,366
48,656,813
Property and equipment, net
288,193
273,632
Intangible assets, net
7,337,322
7,549,520
Goodwill
1,540,162
1,540,162
Other assets
897,051
706,840
Deferred costs
3,463,197
3,523,497
Total assets
$
54,422,291
$
62,250,464
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
$
3,154,171
$
1,557,507
Accrued expenses
8,064,329
6,464,445
Accrued dividends payable
57,328
56,404
Deferred revenue
513,662
513,662
Total current liabilities
11,789,490
8,592,018
Other liabilities
703,074
-
Deferred revenue
6,942,306
7,070,725
Total liabilities
19,434,870
15,662,743
Commitments and contingencies
Stockholders’ equity
Convertible participating preferred stock - $0.001 par value;
20,000,000 shares authorized; 2,250,000 shares issued and
outstanding at September 30, 2006 and June 30, 2006 (liquidation
preference $6,750,000)
2,250
2,250
Common stock - par value $0.001; 70,000,000 shares authorized;
41,458,616 and 41,456,616 shares issued and outstanding at September
30, 2006 and June 30, 2006, respectively
41,459
41,457
Additional paid-in capital
134,229,990
133,604,996
Accumulated deficit
(98,778,030)
(86,567,268)
Receivable from stockholder
(300,000)
(340,606)
Accumulated other comprehensive loss
(208,248)
(153,108)
Total stockholders’ equity
34,987,421
46,587,721
Total liabilities and stockholders’ equity
$
54,422,291
$
62,250,464
BIOENVISION, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three months ended
September 30,
2006
2005
Revenue
Product sales
$
1,874,494
$
194,996
Licensing and royalty revenue
990,078
400,130
Research and development contract revenue
-
75,092
Total revenue
2,864,572
670,218
Costs and expenses
Cost of products sold, including royalty expense of $361,000 and
$201,000 for the three months ended September 30, 2006 and 2005,
respectively
422,728
328,291
Research and development
9,269,582
2,430,918
Selling, general and administrative
5,468,891
2,887,462
Depreciation and amortization
241,700
224,283
Total costs and expenses
15,402,901
5,870,954
Loss from operations
(12,538,329)
(5,200,736)
Interest and finance charges
(47,684)
(66,761)
Interest income
460,319
462,905
Net loss
(12,125,694)
(4,804,592)
Preferred stock dividend
(85,068)
(85,068)
Loss applicable to common stockholders
$
(12,210,762)
$
(4,889,660)
Basic and diluted net loss per share applicable to common
stockholders
$
(0.29)
$
(0.12)
Weighted average shares used in computing
41,456,942
40,572,626
basic and diluted net loss per share
Bioenvision (NasdaqGM:BIVN) today announced financial results for
the first quarter ended September 30, 2006. Highlights of the quarter
include:
-- Bioenvision successfully conducted its Evoltra(R)
(clofarabine) marketing launch at SIOP conference in September
2006;
-- Bioenvision entered into a licensing agreement to acquire
Evoltra(R) marketing rights in Japan and Southeast Asia;
-- Bioenvision records $2.9 million of revenue for the quarter;
up from $670,000 in the quarter ended September 30, 2005;
-- Bioenvision appoints Vice President, Regulatory Affairs.
"We continue to make strong progress in terms of Evoltra(R)
marketing and development activities and in the build out of our
infrastructure," commented David P. Luci, Chief Financial Officer and
General Counsel of Bioenvision.
"We will now focus our development efforts on expanding
Evoltra(R)'s commercial potential," said Dr. Christopher B. Wood,
Bioenvision's Chairman and Chief Executive Officer. "Our next target
in Evoltra development is the filing, before year's end, for approval
with the European Commission to treat elderly patients with AML who
are unfit for intensive chemotherapy. Then we plan to position
Evoltra(R) into other hematology indications, such as MDS and chronic
leukemia," Dr. Wood added.
For the three months ended September 30, 2006 and 2005,
Bioenvision recorded revenues of $2,865,000 and $670,000,
respectively. This increase of 328% is due to an increase in product
sales of Evoltra(R) due to marketing approval received in Q4 of 2006
as well as an increase in license and royalty revenue of $590,000.
Selling, General and Administrative expenses for the three months
ended September 30, 2006 and 2005 were approximately $5,469,000 and
$2,887,000, respectively. This increase of 89.4% is due to an increase
in sales and marketing costs associated with the marketing launch of
Evoltra(R) in September 2006. The Company also experienced an increase
in expenses of approximately $1,403,000 relating to the build-up of a
sales and marketing and administrative infrastructure throughout
Europe upon approval of Evoltra(R) in May 2006. The Company also
recognized an increase in the non-cash charge of stock-based
compensation of $223,000.
Research and development costs for the three months ended
September 30, 2006 and 2005 were $9,270,000 and $2,431,000,
respectively. This increase of 281.3% is due to the Company licensing
clofarabine in Japan and Southeast Asia; a territory previously
ungranted by clofarabine's inventor. The increase is also due to the
increased development activities and ongoing clinical trials of
clofarabine for pediatric and adult leukemias and psoriasis. Excluding
the one-time costs associated with our having licensed Evoltra(R)
marketing rights in Japan and Southeast Asia, we would have recorded
R&D costs for the three months ended September 30, 2006 and 2005 of
$5,317,000 and $2,431,000, respectively (see Non-GAAP reconciliation
set forth below).
Net loss available to shareholders was $12,211,000, or $0.29 loss
per share for the three months ended September 30, 2006, compared with
net loss available to shareholders of $4,890,000, or $0.12 loss per
share for the three months ended September 30, 2005.
Bioenvision had cash and cash equivalents and short-term
investments at September 30, 2006 of $35,777,000 compared with
$45,015,000 at June 30, 2006. The decrease in the cash position is due
to the cash burn associated with our licensing marketing rights to
clofarabine in Japan and Southeast Asia as well as ongoing clinical
trials for clofarabine and modrenal as well as general administrative
costs associated with the marketing launch of Evoltra(R) and the
implementation of a sales force within the EU.
Reconciliation of Non-US GAAP Financial Measure
Adjusted net loss applicable to common stockholders defined as net
loss applicable to common shareholders less one-time expense for the
Japanese license agreement recorded for the quarters ended September
30, 2006 and 2005, respectively.
-0-
*T
Quarter ended September 30,
2006 2005
--------------- ------------
Net loss applicable to common
stockholders, as reported $(12,210,762) $(4,889,660)
Add: One-time charge for Japanese license
agreement 3,953,074 -
--------------- ------------
Adjusted net loss applicable to common
stockholders $(8,257,688) $(4,889,660)
=============== ============
Basic and diluted net loss per share of
common stock, as reported $(0.29) $(0.12)
Adjusted basic and diluted net loss per
share of common stock $(0.20) $(0.12)
Weighted-average shares used in computing
basic & diluted net loss per share 41,456,942 40,572,626
*T
-0-
*T
Conference Call
Conference Call Information:
Date: 11/9/06
Time: 12:00PM Eastern
Toll free (US & Canada): 866-585-6398
International: 416-849-9626
Web cast: www.bioenvision.com
A replay of the call and web cast will be available for 14 days.
Replay number (US & Canada): 866-245-6755
Replay number international: 416-915-1035
Replay passcode: 816197
Web cast replay: www.bioenvision.com
*T
About Bioenvision
Bioenvision's primary focus is the acquisition, development,
distribution and marketing of compounds and technologies for the
treatment of cancer. Bioenvision has a broad pipeline of products for
the treatment of cancer, including: Evoltra(R), 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.
Bioenvision is also developing anti-infective technologies, including
the OLIGON(R) technology; an advanced biomaterial that has been
incorporated into various FDA approved medical devices and Suvus(R),
an antimicrobial agent currently in clinical development for
refractory chronic hepatitis C infection. 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
September 30, June 30,
2006 2006
------------- -------------
ASSETS (unaudited)
Current assets
Cash and cash equivalents $ 4,215,118 $ 3,377,937
Short-term securities 31,562,264 41,637,106
Accounts receivable, less allowances of
$899,000 3,233,091 2,369,446
Inventories 425,402 427,514
Other current assets 1,460,491 844,810
------------- -------------
Total current assets 40,896,366 48,656,813
Property and equipment, net 288,193 273,632
Intangible assets, net 7,337,322 7,549,520
Goodwill 1,540,162 1,540,162
Other assets 897,051 706,840
Deferred costs 3,463,197 3,523,497
------------- -------------
Total assets $ 54,422,291 $ 62,250,464
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $ 3,154,171 $ 1,557,507
Accrued expenses 8,064,329 6,464,445
Accrued dividends payable 57,328 56,404
Deferred revenue 513,662 513,662
------------- -------------
Total current liabilities 11,789,490 8,592,018
Other liabilities 703,074 -
Deferred revenue 6,942,306 7,070,725
------------- -------------
Total liabilities 19,434,870 15,662,743
Commitments and contingencies
Stockholders' equity
Convertible participating preferred 2,250 2,250
stock - $0.001 par value; 20,000,000
shares authorized; 2,250,000 shares
issued and outstanding at September 30,
2006 and June 30, 2006 (liquidation
preference $6,750,000)
Common stock - par value $0.001; 41,459 41,457
70,000,000 shares authorized;
41,458,616 and 41,456,616 shares issued
and outstanding at September 30, 2006
and June 30, 2006, respectively
Additional paid-in capital 134,229,990 133,604,996
Accumulated deficit (98,778,030) (86,567,268)
Receivable from stockholder (300,000) (340,606)
Accumulated other comprehensive loss (208,248) (153,108)
------------- -------------
Total stockholders' equity 34,987,421 46,587,721
------------- -------------
Total liabilities and stockholders'
equity $ 54,422,291 $ 62,250,464
============= =============
*T
-0-
*T
BIOENVISION, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three months ended
September 30,
2006 2005
------------- ------------
Revenue
Product sales $ 1,874,494 $ 194,996
Licensing and royalty revenue 990,078 400,130
Research and development contract revenue - 75,092
------------- ------------
Total revenue 2,864,572 670,218
Costs and expenses
Cost of products sold, including royalty 422,728 328,291
expense of $361,000 and $201,000 for the
three months ended September 30, 2006
and 2005, respectively
Research and development 9,269,582 2,430,918
Selling, general and administrative 5,468,891 2,887,462
Depreciation and amortization 241,700 224,283
------------- ------------
Total costs and expenses 15,402,901 5,870,954
------------- ------------
Loss from operations (12,538,329) (5,200,736)
Interest and finance charges (47,684) (66,761)
Interest income 460,319 462,905
------------- ------------
Net loss (12,125,694) (4,804,592)
Preferred stock dividend (85,068) (85,068)
------------- ------------
Loss applicable to common stockholders $(12,210,762) $(4,889,660)
============= ============
Basic and diluted net loss per share
applicable to common stockholders $ (0.29) $ (0.12)
============= ============
Weighted average shares used in computing 41,456,942 40,572,626
============= ============
basic and diluted net loss per share
*T