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. -0- *T 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 ============
============ *T -0- *T 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 *T
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