MORRIS PLAINS, N.J., Sept. 8 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a leading biopharmaceutical company focused on developing
monoclonal antibodies, today reported revenues of $0.6 million and a net loss
of $10.1 million, or $0.19 per share, for the fourth quarter of fiscal year
2005, which ended June 30, 2005. This compares to revenues of $0.9 million
and a net loss of $6.8 million, or $0.14 per share, for the same period last
year. For the fiscal year 2005, the Company reported revenues of $3.8 million
and a net loss of $26.8 million, or $0.50 per share. This compares to
revenues of $4.3 million and a net loss of $22.4 million, or $0.45 per share,
for fiscal year 2004. The increase in net loss for the fourth quarter and
the fiscal year was due to increased research and development expenses,
particularly related to the Phase III clinical trials for epratuzumab in
patients with lupus.
At June 30, 2005, the Company had $33.6 million in cash and liquid
securities, including $3.8 million of restricted securities that collateralize
the New Jersey Economic Development Authority financing completed in May 2003
for the construction of the Company's expanded manufacturing facilities, and
$14.3 million of the proceeds from the April 2005, private placement of 5%
senior convertible notes and common stock warrants that was placed in escrow
pending receipt of shareholder approval to increase the Company's authorized
common stock. With the August 19, 2005 shareholder approval to increase the
authorized shares of common stock to 110 million, there is no longer a
restriction on any of the proceeds from the issuance of the 5% senior
convertible notes into shares of common stock. As a result, the $14.3 million
previously held in escrow is available for general corporate purposes.
"Our financial results for the fiscal year 2005 were in line with our
expectations. The Company initiated two pivotal Phase III clinical trials in
May 2005, to further evaluate the safety and efficacy of the Company's lead
drug candidate, epratuzumab, for the treatment of patients with systemic lupus
erythematosus (SLE). Known as ALLEVIATE or Alleviate Lupus Affliction with
Epratuzumab and Validate its Autoimmune Safety and Efficacy, both trials are
randomized, double-blinded, placebo-controlled, multi-center studies using the
BILAG (British Isles Lupus Assessment Group) index to monitor and assess
disease activity. One trial, ALLEVIATE A, is for patients with severe SLE
flares, and the second trial, ALLEVIATE B, is for patients with moderately
active SLE. The higher expenses incurred in the fourth quarter were the
result of launching our ALLEVIATE trials. To provide funding for the trials
and retire certain existing outstanding debt, we issued approximately $38
million of 5% senior convertible notes and common stock warrants in April
2005. With the release of funds that were held in escrow following the
approval of the April financing by our shareholders in August, 2005, the $14.3
million is available for general corporate purposes," commented Gerard G.
Gorman, the Company's Vice President, Finance, and Chief Financial Officer.
"We believe we are a stronger Company than we were a few months ago,
especially in light of the positive ruling from the Nasdaq Listing and
Qualification Panel, the support we received from our shareholders for the
April financing, and the launching of our ALLEVIATE trials," said Cynthia L.
Sullivan, President and Chief Executive Officer of the Company. "Our efforts
in lupus are now being recognized with our ALLEVIATE trials often cited in
investment letters and analyst reports, and the Company's involvement in
seminars on lupus by advocacy groups and by Wall Street."
Other developments of note during the fourth quarter of fiscal year 2005
were as follows:
* The Company and its subsidiary, IBC Pharmaceuticals, Inc., presented
three posters at the 41st Annual Meeting of the American Society of
Clinical Oncology on a potentially new diagnostic test for pancreatic
cancer, clinical update on radioimmunotherapy of colorectal cancer, and
pretargeted radioimmunotherapy.
* The Company presented initial clinical results from its Phase I/II
trial of epratuzumab for the treatment of Sjogren's syndrome, an
autoimmune disease that currently affects between 2 to 4 million
Americans, at the 2005 Annual European Congress of Rheumatology.
* The Company was awarded U.S. and Australian patents for autoimmune
therapy using monoclonal antibodies that bind to the CD22 antigen
present on B-lymphocytes.
* The Company and its subsidiary, IBC Pharmaceuticals, Inc., presented
five studies at the 52nd Annual Meeting of the Society of Nuclear
Medicine on radiation dosimetry, pretargeted radioimmunotherapy,
molecular imaging with pretargeting, fractionated radioimmunotherapy,
and positron emission tomography.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company focused on
the development of monoclonal, antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases. We have developed
a number of advanced proprietary technologies that allow us to create
humanized antibodies that can be used either alone in unlabeled or "naked"
form, or conjugated with radioactive isotopes, chemotherapeutics or toxins, in
each case to create highly targeted agents. Using these technologies, we have
built a pipeline of therapeutic product candidates that utilize several
different mechanisms of action. Our lead product candidate, epratuzumab, is
currently in two pivotal Phase III trials for the treatment of patients with
moderate and severe lupus (ALLEVIATE A and B). At present, there is no cure
for lupus and no new lupus treatment drug has been approved in the U.S. in the
last 40 years. We believe that our portfolio of intellectual property, which
includes approximately 90 patents issued in the United States, and more than
250 other issued patents worldwide, protects our product candidates and
technologies. Visit our web site at http://www.immunomedics.com.
This release, in addition to historical information, may contain forward-
looking statements made pursuant to the Private Securities Litigation Reform
Act of 1995. Such statements, including statements regarding clinical trials,
out-licensing arrangements, and capital raising activities, involve
significant risks and uncertainties and actual results could differ materially
from those expressed or implied herein. Factors that could cause such
differences include, but are not limited to, risks associated with new product
development (including clinical trials outcome and regulatory
requirements/actions), competitive risks to marketed products and availability
of required financing and other sources of funds on acceptable terms, if at
all, as well as the risks discussed in the Company's filings with the
Securities and Exchange Commission. The Company is not under any obligation,
and the Company expressly disclaims any obligation, to update or alter any
forward-looking statements, whether as a result of new information, future
events or otherwise.
For More Information:
Dr. Chau Cheng
Associate Director, Investor Relations & Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
IMMUNOMEDICS, INC.
Condensed Consolidated Balance Sheets
June 30, June 30,
2005 2004
ASSETS
Current Assets:
Cash and cash equivalents $11,937,483 $9,133,297
Marketable securities 3,547,507 4,345,891
Accounts receivable 409,458 788,647
Inventory 493,603 340,133
Other current assets 785,677 748,921
Restricted securities 15,575,200 1,275,200
32,748,928 16,632,089
Property and equipment, net 10,152,115 11,532,646
Restricted securities 2,550,400 3,825,600
Other long-term assets 2,471,706 98,243
$47,923,149 $32,088,578
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $9,422,923 $6,296,713
Long-term debt 36,743,233 13,825,600
Other liabilities 2,748,240
Minority interest 272,160 382,121
Stockholders' (deficit) equity (1,263,407) 11,584,144
$47,923,149 $32,088,578
Condensed Consolidated Statements of Operations
Three Months Ended Year Ended
June 30, June 30,
2005 2004 2005 2004
Revenues:
Product sales $543,312 816,745 3,349,483 3,607,413
License
fee and
other
revenues 66,287 52,253 329,674 512,256
Research &
development - 42,422 134,285 186,171
Revenues $609,599 911,420 3,813,442 4,305,840
Costs and
Expenses 11,117,806 7,711,943 32,514,259 27,299,074
Operating Loss (10,508,207) (6,800,523) (28,700,817) (22,993,234)
Interest and
Other Income 376,822 11,843 1,557,763 403,843
Net Loss before
Income Tax
Expense (10,131,385) (6,788,680) (27,143,054) (22,589,391)
Income Tax
(Expense)
Benefit 37,555 (36,714) 385,120 234,136
Net Loss $(10,093,830) $(6,825,394) $(26,757,934) $(22,355,255)
Net Loss per
Common Share,
Basic and
Diluted $(0.19) (0.14) (0.50) (0.45)
Weighted
average number
of common
shares
outstanding 54,073,059 49,893,627 53,683,834 49,886,484
SOURCE Immunomedics, Inc.
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Related links:
http://www.Immunomedics.com
Company News On-Call:
http://www.prnewswire.com/comp/113121.html
CONTACT:
Dr. Chau Cheng, Associate Director, Investor
Relations & Business Analysis of Immunomedics, Inc.,
+1-973-605-8200, ext. 123, ccheng@immunomedics.com
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