Bioenvision (NASDAQ:BIVN)
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Bioenvision (NASDAQ:BIVN) today announced financial
results for the three and nine months ended March 31, 2005. Highlights
of the quarter and recent weeks include:
-- Bioenvision reported excellent interim results from clinical
studies of clofarabine at the 6th International Symposium on
Leukemia and Lymphoma
-- First patients were enrolled in a Phase II clinical trial for
treatment of chronic hepatitis C with Virostat
-- Public offering Bioenvision stock raised $56.4 million
-- Revenues increased 65% and net loss narrowed 17% (previously
disclosed at 29%)
The Company had previously released its earnings on May 16, 2005,
prior to the identification of an error in the accounting for income
taxes in connection with the purchase of Pathagon, Inc, which took
place in February, 2002. These adjustments and the related restatement
to our historical financial statements, as disclosed in our Form 8-K
filed May 26, 2005, are further discussed in our Annual Report Form
10-KSB for the fiscal year ended June 30, 2004, as amended on June 29,
2005 and our Quarterly Report on Form 10-QSB for the fiscal third
quarter ended March 31, 2005 which we filed on June 29, 2005.
"We have made considerable progress in developing our product
portfolio over the past 12 months and now have multiple products in
clinical trials," commented Christopher 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, and we await an opinion from the EMeA, which is our
next important milestone."
Dr. Wood continued, "In addition, we are currently selling our
second product, Modrenal(R), in the United Kingdom using our own sales
force. Modrenal(R) is approved in the U.K. for the treatment of
post-menopausal advanced breast cancer. In addition to these approved
cancer therapeutics, during this quarter, the Company began Phase II
clinical trials with Virostat for the treatment of Hepatitis C.
Total revenues for the third quarter of fiscal 2005 were $1.4
million, up 65% over $0.85 million for the third quarter of fiscal
2004. The increase was primarily due to an increase in licensing and
royalty revenue attributed to R&D reimbursements, royalties and
amortization of milestone payments. For the third quarter of 2005, the
Company's net loss narrowed significantly to $3.1 million, (previously
disclosed at $2.9 million) or $0.08 per share, compared with a net
loss of $3.7 million, (previously disclosed at $4.1 million) or $0.19
per share, (previously disclosed at $0.21 per share) for the third
quarter of fiscal 2004.
Selling, general and administrative expenses for the three months
ended March 31, 2005 and 2004 were approximately $2.1 million and $3.7
million, respectively, representing a decrease of approximately $1.6
million. This decrease was primarily due to a decrease in costs
associated with the variable accounting treatment associated with
certain options issued to an officer of the Company of approximately
$2.6 million, offset by an increase in costs associated with the
Company's increased headcount.
Research and development costs for the three months ended March
31, 2005 were $2.1 million, compared with $0.99 million in the prior
year's period. The increase in research and development expenses was
due to costs primarily associated with increased development
activities and ongoing clinical trials for clofarabine for pediatric
leukemia in Europe, adult AML (Acute Myeloid Leukemia) and Modrenal(R)
for breast cancer and prostate cancer.
Bioenvision had cash and cash equivalents as of March 31, 2005 of
$70.3 million, compared with $18.9 million as of June 30, 2004. The
increase in the cash position is due to the public offering of 7.5
million shares of common stock in February 2005, which raised $56.4
million in net proceeds to the Company.
For the nine months ended March 31, 2005 and 2004, Bioenvision
recorded revenues of $3.7 million and $1.8 million, respectively. SG &
A expenses for the nine months ended March 31, 2005 and 2004 were
approximately $6.9 million and $7.1 million, respectively. Research
and development costs for the nine months ended March 31, 2005 were
$6.0 million, compared with $2.5 million for the nine months ended
March 31, 2004. Net loss was $10.2 million, (previously disclosed at
$9.8 million) or $0.32 per share for the first nine months of fiscal
2005, compared with net loss of $7.8 million, (previously disclosed at
$8.4 million) or $0.43 per share (previously disclosed at $0.50 per
share) in the same period last year.
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 SHEET
(Unaudited)
March 31, June 30,
2005 2004
----------- ------------
ASSETS (Restated)
Current assets
Cash and cash equivalents $70,334,939 $18,875,675
Restricted cash 290,000 290,000
Deferred costs 231,171 241,824
Accounts receivable 2,204,662 2,627,773
Inventory 433,335 -
Other current assets 582,415 253,311
------------ ------------
Total current assets 74,076,522 22,288,583
Property and equipment, net 262,207 47,857
Intangible assets, net 13,799,903 14,563,660
Goodwill 1,540,162 1,540,162
Security deposits 211,796 79,111
Deferred costs 3,483,419 3,651,471
------------ ------------
Total assets $93,374,009 $42,170,844
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $3,014,427 $1,495,866
Accrued expenses 1,712,585 1,322,584
Accrued dividends payable 55,479 90,141
Deferred revenue 498,607 551,828
------------ ------------
Total current liabilities 5,281,098 3,460,419
Deferred revenue 7,562,251 7,909,598
Deferred tax liability - - -
------------ ------------
Total liabilities 12,843,349 11,370,017
Commitments and contingencies - -
Stockholders' equity
Preferred stock - $0.001 par value;
20,000,000 shares authorized; 2,250 3,342
2,250,000 and 3,341,666 shares issued
and outstanding at March 31, 2005 and
June 30, 2004 (liquidation preference
$6,750,000 and $10,024,998,
respectively)
Common stock - par value $0.001;
70,000,000 shares authorized; 40,449 28,316
40,448,948 and 28,316,163 shares issued
and outstanding at March 31, 2005 and
June 30, 2004, respectively
Additional paid-in capital 128,684,678 68,517,702
Deferred compensation (158,280) (223,990)
Accumulated deficit (48,155,869) (37,664,141)
Accumulated other comprehensive income 117,432 139,598
------------ ------------
Stockholders' equity 80,530,660 30,800,827
------------ ------------
Total liabilities and stockholders'
equity $93,374,009 $42,170,844
============ ============
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three months ended Nine months ended
March 31, March 31,
------------ ------------ ------------- ------------
2005 2004 2005 2004
------------ ------------ ------------- ------------
(Restated) (Restated)
Revenue
Licensing and
royalty revenue $430,411 $76,452 $1,012,068 $212,988
Product sales 149,364 - 364,495 -
Research and
development
contract
revenue 819,194 770,042 2,283,657 1,545,042
------------ ------------ ------------- ------------
Total revenue 1,398,969 846,494 3,660,220 1,758,030
Costs and expenses
Cost of products
sold 99,061 - 229,417 -
Research and
development 2,136,849 994,307 5,986,496 2,545,128
Selling, general
and
administrative 2,074,430 3,721,937 6,885,382 7,079,367
(includes stock
based compensation
income (expense)
of $713,116 and
$(2,526,943)
for the three
months ended
March 31, 2005
and 2004,
respectively,
and $(687,290)
and $(3,625,535)
for the nine
months ended
March 31, 2005
and 2004,
respectively)
Depreciation and
amortization 346,504 343,456 1,028,197 1,023,325
------------ ------------ ------------- ------------
Total costs and
expenses 4,656,844 5,059,700 14,129,492 10,647,820
------------ ------------ ------------- ------------
Loss from
operations (3,257,875) (4,213,206) (10,469,272) (8,889,790)
Interest income 185,465 14,576 297,479 49,465
------------ ------------ ------------- ------------
Net loss before
income tax
benefit (3,072,410) (4,198,630) (10,171,793) (8,840,325)
Income tax
benefit - 506,087 - 1,065,575
------------ ------------ ------------- ------------
Net loss (3,072,410) (3,692,543) (10,171,793) (7,774,750)
Cumulative
preferred stock
dividend (83,219) (175,704) (319,935) (587,971)
------------ ------------ ------------- ------------
Net loss
available to
common
stockholders $(3,155,629) $(3,868,247) $(10,491,728) $(8,362,721)
============ ============ ============= ============
Basic and diluted
net loss per
share of common
stock $(0.08) $(0. 19) $(0.33) $(0.46)
============ ============ ============= ============
Weighted average 37,602,163 19,912,396 31,907,864 18,122,445
shares used in ============ ============ ============= ============
computing basic
and diluted net
loss per share
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