Bioenvision (NASDAQ:BIVN)
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Bioenvision (NasdaqGM:BIVN) today announced financial
results for its fourth quarter and fiscal year ended June 30, 2006.
Highlights of the year include:
-- EMeA formally approves Evoltra(R) (clofarabine) for the
treatment of acute lymphoblastic leukemia (ALL) in pediatric
patients who have relapsed or are refractory to at least two
prior regimens and where there is no other treatment option
anticipated to result in a durable response;
-- Bioenvision files a marketing authorization application with
Egyptian authorities for Suvus(TM) for the treatment of
chronic hepatitis C;
-- Revenues for the fourth quarter 2006 increased 82.3% to $1.8
million, up from $991k for the fourth quarter of 2005.
-- Net loss applicable to common stockholders for the fourth
quarter 2006 decreased 52.6% to $0.18 per share, down from
$0.38 per share for the fourth quarter of 2005.
-- Revenues for the year ended June 30, 2006 increased 14.1% to
$5.3 million, up from $4.7 million for the year ended June 30,
2005;
-- Net loss applicable to common stockholders for the year ended
June 30, 2006 decreased 18.1% to $0.59 per share from $0.72
per share for the year ended June 30, 2005;
-- Net loss applicable to common stockholders for the year ended
June 30, 2006, adjusted to exclude employee stock-based
compensation recorded for the year, decreased 31.5% to $0.50
per share, down from a net loss of $0.73 per share, for the
year ended June 30, 2005. (Refer to our reconciliation table
of GAAP net loss applicable to common stockholders to the
adjusted net loss applicable to common stockholders).
"We will now focus our Evoltra(R) development efforts on other,
larger patient populations to expand Evoltra(R)'s commercial
potential," said Dr. Christopher B. Wood, Bioenvision's Chairman and
Chief Executive Officer. "Our next target in Evoltra development is
our filing for approval with the European Commission before year's end
to treat elderly patients with AML who are unfit for intensive
chemotherapy," Dr. Wood added.
"We continue to make strong progress both fiscally and in terms of
achieving our regulatory, development and marketing milestones,
primarily with Evoltra(R) (clofarabine) but also with Modrenal(R) and
Suvus(R), which may become significant value drivers for the company
in the future," commented David P. Luci, Chief Financial Officer and
General Counsel of Bioenvision. "We are delighted especially with the
EMeA approval of Evoltra(R) which virtually eliminates the regulatory
risk inherent in the EU drug development process," added Mr. Luci.
For the fourth quarters ended June 30, 2006 and 2005, the Company
recorded revenues of approximately $1,806,000 and $991,000,
respectively. The increase in revenues of 82.3% or approximately
$815,000 is primarily due to the increase, research and development
contract revenue of approximately $855,000 due to an increase in
Evoltra(R) sales and certain research and development reimbursements,
offset by decreases in product sales.
For the years ended June 30, 2006 and 2005, Bioenvision recorded
revenues of approximately $5,309,000 and $4,651,000, respectively.
This increase of 14.1% or approximately $658,000 is primarily due to
an increase in license and royalty revenue of approximately $466,000
due to an increase in royalties received from Genzyme on North
American sales of Clofarabine, research and development contract
revenue of approximately $134,000 due to an increase in Named Patient
Program sales and certain research and development reimbursements, and
product sales of approximately $58,000.
Selling, General and Administrative expenses for the fourth
quarters ended June 30, 2006 and 2005 were approximately $4,200,000
and $3,501,000 respectively. This increase of 20.0% or approximately
$699,000 is primarily due to the increase in the internal build-out of
the Company upon approval of Evoltra(R) of approximately $449,000.
Selling, General and Administrative expenses for the years ended
June 30, 2006 and 2005 were approximately $16,563,000 and $10,182,000,
respectively. This increase of 62.7% is primarily due to the Company
recognizing stock-based compensation expense, a non-cash item, due to
the adoption of SFAS 123(R) on July 1, 2005 as well as 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 year ended June 30, 2006, the
Company recorded approximately $3,223,000 of stock based compensation
expense as compared to approximately $794,000 for the year ended June
30, 2005. The Company also saw an increase in sales and marketing
expenses of approximately $1,333,000 relating to the build-up of a
sales and marketing and administrative infrastructure throughout
Europe upon approval of Clofarabine in May 2006.
Research and development costs for the fourth quarters ended June
30, 2006 and 2005 were approximately $4,500,000 and $4,908,000,
respectively. The decrease in research and development costs of 8.3%
or approximately $408,000 is due to the accrual of $1.5 million of
milestone expenses to SRI in the fourth quarter of 2005 partially
offset by an increase in Evoltra development costs of approximately
$400,000 during the fourth quarter of 2006.
Research and development costs for the years ended June 30, 2006
and 2005 were approximately $11,727,000 and $10,895,000, respectively.
This increase of 7.6% 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), along with pre-menopausal breast cancer studies in Europe
and Suvus for ongoing, multi-center investigator sponsored Phase II
clinical trials being conducted in Egypt and Southern Europe.
Net loss applicable to common stockholders was approximately
$7,246,000, or $0.18 per share for the fourth quarter ended June 30,
2006, compared with net loss applicable to common stockholders of
approximately $14,175,000, or $0.38 per share for the fourth quarter
ended June 30, 2005.
Net loss applicable to common stockholders was approximately
$24,236,000, or $0.59 per share for the year ended June 30, 2006,
compared with net loss applicable to common stockholders of
approximately $24,667,000, or $0.72 per share for the year ended June
30, 2005.
Bioenvision had cash and cash equivalents at June 30, 2006 of
approximately $3,378,000, compared with approximately $31,408,000 at
June 30, 2005. The Company has also invested an additional $41,637,000
of cash in short-term certificates of deposit with maturities ranging
from 3 to 12 months.
Reconciliation of Non-US GAAP Financial Measure
Adjusted net loss applicable to common stockholders defined as net
loss applicable to common shareholders less employee stock-based
compensation recorded for the years ended June 30, 2006 and 2005,
respectively.
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Quarter ended June 30, Years ended June 30,
2006 2005 2006 2005
---- ---- ---- ----
Net loss
applicable to
common
stockholders,
as reported $(7,246,151) $(14,175,137) $(24,236,263) $(24,666,864)
Add: Employee
stock-based
compensation
expense
(income)
recorded 660,796 137,599 3,717,763 (227,417)
------------ ------------- ------------- -------------
Adjusted net
loss
applicable to
common
stockholders $(6,585,355) $(14,037,538) $(20,518,500) $(24,894,281)
============ ============= ============= =============
Basic and
diluted net
loss per share
of common
stock, as
reported $(0.18) $(0.38) $(0.59) $(0.72)
Adjusted basic
and diluted
net loss per
share of
common stock $(0.16) $(0.37) $(0.50) $(0.73)
Weighted-
average shares
used in
computing
basic &
diluted net
loss per share 41,260,120 37,685,570 40,865,384 34,042,391
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Conference Call
Bioenvision management will host a conference call to discuss
these results today at 12:00 p.m. EDT. To participate in the live call
by telephone, please dial 866-585-6398 from the U.S. or 416-849-9626
from outside the U.S. A telephone replay of the call will be available
beginning at 4:00 p.m. EDT September 11 until 11:59 p.m. EDT October
25 by dialing 866-245-6755 (U.S.) or 416-915-1035 (International) and
entering reservation number 739924.
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,
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(TM),
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.
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BIOENVISION, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
June 30, June 30,
2006 2005
---- ----
ASSETS
Current assets
Cash and cash equivalents $3,377,937 $31,407,533
Restricted cash - 290,000
Short-term securities 41,637,106 32,746,948
Accounts receivable, less allowances of
$898,714 and of $869,220, respectively 2,369,446 1,785,779
Inventories 427,514 277,908
Prepaids and other current assets 844,810 342,628
------------ ------------
Total current assets 48,656,813 66,850,796
Property and equipment, net 273,632 279,778
Intangible assets, net 7,549,520 8,252,936
Goodwill 1,540,162 1,540,162
Other assets 706,840 209,665
Deferred costs 3,523,497 3,656,798
------------ ------------
Total assets $62,250,464 $80,790,135
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $1,557,507 $1,602,267
Accrued expenses and other current
liabilities 6,464,445 4,581,444
Accrued dividends payable 56,404 56,404
Deferred revenue 513,662 498,607
------------ ------------
Total current liabilities 8,592,018 6,738,722
Deferred revenue 7,070,725 7,437,598
------------ ------------
Total liabilities 15,662,743 14,176,320
------------ ------------
Commitments and contingencies - -
Stockholders' equity
Convertible participating preferred stock
- $0.001 par value; 20,000,000 shares
authorized; 2,250,000 issued and
outstanding at June 30, 2006 and June 30,
2005, respectively (liquidation
preference $6,750,000 and $6,750,000,
respectively) 2,250 2,250
Common stock - $0.001 par value;
70,000,000 shares authorized; 41,456,616
and 40,558,948 shares issued and
outstanding at June 30, 2006 and June 30,
2005, respectively 41,457 40,559
Additional paid-in capital 133,604,996 128,946,717
Deferred compensation - (145,646)
Accumulated deficit (86,567,268) (62,331,005)
Receivable from stockholder (340,606)
Accumulated other comprehensive income
(loss) (153,108) 100,940
------------ ------------
Total stockholders' equity 46,587,721 66,613,815
------------ ------------
Total liabilities and stockholders'
equity $62,250,464 $80,790,135
============ ============
BIOENVISION, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED JUNE 30, 2006, 2005, and 2004
2006 2005 2004
------------- ------------- -------------
Revenue
License and royalty
revenue $1,929,526 $1,463,326 $1,014,717
Product sales 668,975 611,346 -
Research and
development contract
revenue 2,710,571 2,576,502 2,087,497
------------- ------------- -------------
Total revenue 5,309,072 4,651,174 3,102,214
------------- ------------- -------------
Costs and expenses
Cost of products sold
(including royalty
expense of $1,277,411,
$524,755 and $0 for the
years ended June 30,
2006, 2005 and 2004,
respectively) 1,662,975 921,262 -
Research and development 11,726,981 10,894,925 4,882,574
Provision for bad debts 24,564 869,220 -
Selling, general and
administrative 16,562,770 10,181,711 9,082,420
Depreciation and
amortization 974,440 1,438,517 1,348,064
Loss on impairment - 5,276,162 -
------------- ------------- -------------
Total costs and expenses 30,951,730 29,581,797 15,313,058
------------- ------------- -------------
Loss from operations (25,642,658) (24,930,623) (12,210,844)
Interest income (expense)
Interest and finance
charges (66,762) (79,484) -
Interest income 1,810,657 747,322 99,763
------------- ------------- -------------
Net loss before income tax
benefit (23,898,763) (24,262,785) (12,111,081)
Income tax benefit - - 1,459,814
------------- ------------- -------------
Net loss (23,898,763) (24,262,785) (10,651,267)
Cumulative preferred stock
dividend (337,500) (404,079) (856,776)
------------- ------------- -------------
Net loss applicable to
common stockholders $(24,236,263) $(24,666,864) $(11,508,043)
============= ============= =============
Basic and diluted net loss
per share applicable to
common stockholders $(0.59) $(0.72) $(0.57)
============= ============= =============
Weighted-average shares used
in computing basic and
diluted net loss per share
of common stock 40,865,384 34,042,391 20,257,482
============= ============= =============
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