Bioenvision, Inc. (Nasdaq: BIVN) today announced financial results
for the third quarter ended March 31, 2007. In the third quarter
the company filed a marketing authorization application with the
European Medicines Agency (EMEA) for a label extension for
clofarabine in elderly patients with acute myeloid leukemia who are
considered unsuitable for intensive chemotherapy. The filing has
been validated by the Agency and the review process is underway.
�The Company�s number one priority is to expand the indications for
use of Evoltra� (clofarabine) and to realize the full potential for
this very active agent. The application for the label extension in
Europe is an important part of our strategy for building
Bioenvision as a strong commercial enterprise and broadening the
market and revenue opportunity for the company,� said Christopher
B. Wood, M.D., Bioenvision�s chairman and chief executive officer.
James S. Scibetta, Bioenvision�s chief financial officer, added,
�In addition to the regulatory activities, we are also enhancing
our corporate structure and strengthening our balance sheet. Our
recent success raising capital with an over-subscribed book has
yielded a solid balance sheet giving us the flexibility to continue
building a commercial organization and positioning us well to
continue to pursue clinical development and commercialization of
clofarabine globally.� Financial Highlights Total revenue for the
quarter ended March 31, 2007 was $5.0 million, compared to $1.7
million for the same period in 2006. This increase of approximately
$3.3 million or 194% is primarily due to increased Evoltra� sales
in Europe along with an increase in license and royalty revenue.
Total revenue for the nine months ended March 31, 2007 and 2006
were $12.3 million and $3.5 million respectively. This increase of
$8.8 million or 251% is due to increased Evoltra� sales in Europe
along with an increase in license and royalty revenue. Net product
sales of Evoltra� for the quarter ended March 31, 2007 totaled $3.9
million, compared to $1.1 million for the same period in 2006.
Research and development costs for the three months ended March 31,
2007 were $4.7 million, compared to $2.8 million during the
comparable period in 2006. This increase of $1.9 million or 68% is
attributable to Evoltra�s development activities, clinical trials
in Europe, label expansion efforts and the enrollment of patients
in the Phase II trial in Europe for the treatment of adult acute
myeloid leukemia (AML) in elderly patients unfit for intensive
chemotherapy as well as the Phase III trial for the treatment of
AML in elderly patients fit for intensive chemotherapy. Costs for
the nine months ended March 31, 2007 and 2006 were $18.3 million
and $7.2 million respectively. This increase of $11.1 million or
154% is due to the one-time cost of the Japanese license agreement
of approximately $4 million during the first quarter of fiscal
2007, along with clinical trials in Europe, label expansion efforts
and the enrollment of patients in the Phase II trial in Europe for
the treatment of adult acute myeloid leukemia (AML) in elderly
patients unfit for intensive chemotherapy as well as the Phase III
trial for the treatment of AML in elderly patients fit for
intensive chemotherapy. Selling, general and administrative
expenses were $6.9 million for both quarters encompassed in the
three months ended March 31, 2007 and 2006. SG&A costs were
flat due to an increase in costs associated with developing a sales
force in the EU, offset by a decrease in the stock-based
compensation recognized during the quarter along with professional
fees associated with the settlement of litigation in the fourth
quarter of fiscal 2006. Selling, general and administrative
expenses for the nine months ended March 31, 2007 and 2006 were
$18.7 million and $12.4 million respectively. This increase of $6.3
million or 51% is due to costs associated with developing a sales
force in the EU and the internal build out of the Company. Net loss
applicable to shareholders was approximately $7.8 million or $0.18
per share for the three months ended March 31, 2007 compared with a
net loss of approximately $8.2 million or $0.20 per share for the
three months ended March 31, 2006. For the nine-month period, net
loss applicable to shareholders was approximately $27.0 million or
$0.64 per share, compared to approximately $17.0 million or $0.42
per share for the comparable period last year. On March 31, 2007,
Bioenvision had cash and cash equivalents and short-term
investments of $20.6 million compared with $45.0 million at June
30, 2006. The decrease in the cash position is due to the cash burn
associated with an increase in the Company�s development activities
and clinical studies of Evoltra� in Europe, including the process
of filing for approval of the first label expansion for Evoltra�,
one-time payments of approximately $3.3 million for the Japanese
license to clofarabine, and the general administrative costs
associated with the marketing of Evoltra�. Net cash burn for the
quarter ended March 31, 2007 was $8.6 million, compared to our
guidance range of $7-$8 million, due to the timing of certain
receivables beyond the quarter end. We are reaffirming our guidance
for Q4 net cash burn in the range of $7-$8 million. The Company had
approximately 43 million shares outstanding at March 31, 2007. On
April 4, 2007, the Company completed a registered direct offering
of 8 million common shares at $3.75 per share, lower than the
average discount to the current price. Net proceeds to the Company
were approximately $27.6 million. In addition, the Company received
$7.4 million of warrant proceeds resulting from the conversion of
3.9 million warrants during May 2007, resulting in approximately
54.9 million shares outstanding. Accounting for the registered
direct offering and warrant conversions, the Company�s total cash
resources available, on a pro forma basis, are $55.6 million.
Management believes the Company has sufficient cash and cash
equivalents, short-term investments and working capital to continue
currently planned operations over the next 12 months. Dr. Wood
concluded, �We look forward to continuing our progress around
several key initiatives, including: continued revenue growth in our
approved pediatric acute lymphoblastic leukemia (ALL) indication;
moving forward toward adult AML regulatory approval, launch and
revenue growth across Europe; pediatric and adult AML submissions
and approvals in Japan; and lastly clinical data for clofarabine in
myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL)
and solid tumors from our partner Genzyme.� Conference Call and
Webcast Information: Management will conduct a conference call
today, May 8, 2007 at 10:00AM Eastern Time to review the financial
and corporate results for the third quarter 2007. The dial-in
number and passcode information are as follows and a replay of the
call and webcast will be available for 14 days from today: Toll
free (US & Canada): 866-585-6398, International: 416-849-9626,
webcast: www.bioenvision.com Replay number (US & Canada):
866-245-6755, International: 416-915-1035, Replay passcode: 525550,
webcast replay: www.bioenvision.com Upcoming Investor and Medical
Meetings Bioenvision will participate in the European Hematology
Association�s annual conference in Vienna from June 7th to the
10th. The Company is sponsoring a satellite symposium titled
�Advances in Acute Myeloid Leukemia, Treatment Across Age Groups.�
The Company is also co-sponsoring the M.D. Anderson Cancer Center
Symposium on patients with hematologic malignancies. Bioenvision
will have a booth at the SEOP meeting in Stiges on May 17-20, 2007.
Bioenvision will attend the UK NCRI Leukemia Meeting in London on
May 18, 2007. Brokerage Conferences: -- UBS Global Generic and
Specialty pharmaceuticals Conference in New York City. Presentation
on Wednesday, May 9, 2007 at 1:00PM Eastern Time. -- FBR 2007
Growth Conference in New York City. Presentation on Wednesday May
30, 2007 at 8:15AM Eastern Time. -- Needham Sixth Annual
Biotechnology & Medical Technology Conference in New York City
on June 13 & 14, 2007. Presentation time TBA. BIOENVISION, INC.
AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS � � March
31, June 30, ASSETS 2007� 2006� � Current assets Cash and cash
equivalents $ 9,812,027� $ 3,377,937� Short-term investments
10,801,269� 41,637,106� Accounts receivable, net of allowances of
$849,331 and $899,000 8,570,906� 2,369,446� Inventories 1,079,713�
427,514� Other current assets 1,995,051� 844,810� Total current
assets 32,258,966� 48,656,813� � Property and equipment, net
354,953� 273,632� Intangible assets, net 6,891,907� 7,549,520�
Goodwill 1,540,162� 1,540,162� Other assets 253,861� 706,840�
Deferred costs 3,342,597� 3,523,497� � Total assets $ 44,642,446� $
62,250,464� � LIABILITIES AND STOCKHOLDERS� EQUITY � Current
liabilities Accounts payable $ 4,018,178� $ 1,557,507� Accrued
expenses 10,422,939� 6,464,445� Accrued dividends payable 55,478�
56,404� Deferred revenue 513,662� 513,662� Total current
liabilities 15,010,257� 8,592,018� � Deferred revenue 6,685,470�
7,070,725� Total liabilities 21,695,727� 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 March 31, 2007 and June
30, 2006 (liquidation preference $6,750,000) 2,250� 2,250� Common
stock - par value $0.001; 70,000,000 shares authorized; 43,085,406
and 41,456,616 shares issued and outstanding at March 31, 2007 and
June 30, 2006, respectively 43,085� 41,457� Additional paid-in
capital 136,774,165� 133,604,996� Accumulated deficit (113,557,059)
(86,567,268) Receivable from stockholder -� (340,606) Accumulated
other comprehensive loss (315,722) (153,108) Total stockholders�
equity 22,946,719� 46,587,721� � Total liabilities and
stockholders� equity $ 44,642,446� $ 62,250,464� BIOENVISION, INC.
AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited) � Three months ended Nine months ended March 31, March
31, � 2007� � 2006� � 2007� � 2006� � Revenue Net product sales $
3,981,444� $ 124,029� $ 9,543,223� $ 493,005� Licensing and royalty
revenue 976,052� 502,584� 2,775,484� 1,446,633� Research and
development contract revenue � -� � 1,114,482� � -� � 1,562,982� �
Total revenue � 4,957,496� � 1,741,095� � 12,318,707� � 3,502,620�
� Costs and expenses Cost of products sold, including royalty
expense of $854,000 and $316,000 for the three months ended March
31, 2007 and 2006, respectively, and $1,974,000 and $847,000 for
the nine months ended March 31, 2007 and 2006, respectively
985,197� 386,818� 2,305,517� 1,153,127� � Research and development
4,722,263� 2,785,004� 18,306,696� 7,227,185� � Selling, general and
administrative 6,930,633� 6,913,698� 18,721,674� 12,383,350� �
Depreciation and amortization � 275,422� � 247,365� � 757,256� �
728,520� � Total costs and expenses � 12,913,515� � 10,332,885� �
40,091,143� � 21,492,182� � Loss from operations (7,956,019)
(8,591,790) (27,772,436) (17,989,562) � Interest and finance
charges (9,384) -� (66,452) (66,761) Interest income � 267,069� �
453,488� � 1,102,453� � 1,319,568� � Net loss (7,698,334)
(8,138,302) (26,736,435) (16,736,755) � Preferred stock dividend �
(83,218) � (83,219) � (253,356) � (253,355) � Loss applicable to
common stockholders $ (7,781,552) $ (8,221,521) $ (26,989,791) $
(16,990,110) � � Basic and diluted net loss per share applicable to
common stockholders $ (0.18) $ (0.20) $ (0.64) $ (0.42) � �
Weighted average shares used in computing basic and diluted net
loss per share � 43,055,592� � 40,870,688� � 42,317,223� �
40,734,286� About Bioenvision Bioenvision's primary focus is the
acquisition, development 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 Suvus�
which is currently in clinical development for refractory chronic
hepatitis C infection. For more information on Bioenvision please
visit our website 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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