MORRIS PLAINS, N.J., Sept. 8 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU) today reported revenues of $0.9 million and a net loss of
$6.8 million, or $0.14 per share, for the fourth quarter of fiscal year 2004,
which ended June 30, 2004. This compares to revenues of $1.7 million and a
net loss of $3.7 million, or $0.07 per share, for the same period last year.
Revenues declined primarily due to the completion of the sale of research and
development materials in the first quarter of fiscal year 2004, which were
part of the Amgen Agreement. These sales contributed approximately
$.7 million of revenues in the fourth quarter of fiscal year 2003. Expenses
were higher this quarter due to increased research and development activities
and a one-time cost associated with warrants issued to Amgen Inc. for the
return of all rights and clinical results for epratuzumab in April 2004.
For the fiscal year 2004, the Company reported revenues of $4.3 million
and a net loss of $22.4 million, or $0.45 per share. This compares to
revenues of $13.7 million and a net loss of $7.9 million, or $0.16 per share,
for fiscal year 2003. The decline in revenues resulted primarily from the
Company recognizing its final portion of the $18.0 million up-front licensing
payment from Amgen Inc. in the third quarter of fiscal year 2003. At June 30,
2004, the Company had $18.6 million in cash and liquid securities, including
$5.1 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. In August
2004, the Company raised an additional approximately $14 million from the sale
of its common stock to a group of accredited investors.
"The higher expenses incurred in the fourth quarter were the result of a
one-time, non-cash charge for warrants issued to Amgen, and increased research
and development activities. In particular, with the return of epratuzumab
from Amgen, we have increased our manufacturing spending in anticipation of
new clinical trials in lymphoma and autoimmune diseases for our most advanced
potential product. To bolster our cash reserves, we added approximately
$14 million in early August 2004 from the net proceeds of a sale of our common
stock. We will continue to evaluate opportunities to raise additional capital
through licensing of our products and technologies, the sale of debt and/or
equity securities, or some combination of the foregoing as they arise,"
commented Gerard G. Gorman, the Company's Vice President, Finance, and Chief
Financial Officer.
The Company reported the initial clinical results from a European study
with epratuzumab administered to patients with Systemic Lupus Erythematosus
(SLE) at the 7th International Congress on SLE in May 2004 (see
http://www.immunomedics.com/7events/Kaufman_SLE_LL2_final.pdf). This pilot
study established the safety, tolerability, lack of immunogenicity and early
evidence of efficacy in SLE patients. "We are very encouraged with these
results, which now need to be confirmed in larger randomized trials," remarked
Cynthia L. Sullivan, the Company's President and Chief Executive Officer.
Other developments of note during the fourth quarter of fiscal year 2004
were as follows:
* The Company presented six abstracts at the 40th meeting of the American
Society of Clinical Oncology communicating clinical and preclinical
advances in the therapy of non-Hodgkin's lymphoma, multiple myeloma and
colorectal cancer.
* The Company and its subsidiary, IBC Pharmaceuticals, Inc., reported
nine studies at the 51st Annual Meeting of the Society of Nuclear
Medicine on clinical and preclinical progress on therapeutics for non-
Hodgkin's lymphoma, colorectal and pancreatic cancers using
radiolabeled antibodies.
"We remain focused on bringing our potential therapeutic products to the
market expeditiously. The approximately $14 million we raised in August allows
us to maintain our momentum in the development of epratuzumab for the
treatment of non-Hodgkin's lymphoma and systemic lupus erythematosus, while we
continue discussions on worldwide licensing of this product. We have also
begun our Phase I and II clinical studies in certain other indications for
other humanized antibodies, such as those targeting the CD20 antigen expressed
by B-cells in various diseases, another antigen expressed in pancreatic
cancers, and the alpha-fetoprotein marker on primary liver cancers," Ms.
Sullivan added.
Immunomedics, Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of diagnostic imaging and
therapeutic products for the detection and treatment of cancer and other
serious diseases. Integral to these products are highly specific monoclonal
antibodies and antibody fragments designed to deliver radioisotopes and
chemotherapeutic agents to tumors and other sites of disease. Immunomedics
has therapeutic product candidates in clinical development and has two
marketed diagnostic imaging products. Our most advanced therapeutic product
candidate is epratuzumab, for which certain Phase II clinical trials for the
treatment of non-Hodgkin's lymphoma have already been completed.
This release, in addition to historical information, contains forward-
looking statements made pursuant to the Private Securities Litigation Reform
Act of 1995. Such statements, including statements regarding clinical trials,
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 financing and other sources of capital, as well as the risks discussed in
the Company's Annual Report on Form 10-K for the year June 30, 2003. 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.
Company Contact: Chau Cheng, Associate Director, Investor Relations &
Business Analysis, (973) 605-8200, extension 123. Visit the Company's web site
at http://www.immunomedics.com.
IMMUNOMEDICS, INC.
Condensed Consolidated Balance Sheets
June 30, June 30,
2004 2003
ASSETS
Current Assets:
Cash and cash equivalents $9,133,297 $13,601,627
Marketable securities 4,345,891 10,194,813
Accounts receivable 788,647 930,134
Inventory 340,133 839,480
Other current assets 748,921 825,372
Restricted securities 1,275,200 1,275,200
16,632,089 27,666,626
Property and equipment, net 11,532,646 12,298,971
Restricted securities 3,825,600 5,100,800
Other long-term assets 98,243 63,157
$32,088,578 $45,129,554
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $6,296,713 $5,890,946
Long-term debt 13,825,600 5,100,800
Minority interest 382,121 471,044
Stockholders' equity 11,584,144 33,666,764
$32,088,578 $45,129,554
Condensed Consolidated Statements of Operations
Three Months Ended Year Ended
June 30, June 30,
2004 2003 2004 2003
Revenues:
Product sales $816,745 925,322 3,607,413 3,558,435
License fee
and other
revenues 52,253 822,840 512,256 10,127,327
Research &
development 42,422 - 186,171 33,710
Revenues $911,420 1,748,162 4,305,840 13,719,472
Costs and Expenses 7,711,943 5,661,935 27,299,074 23,532,924
Operating Loss (6,800,523) (3,913,773) (22,993,234) (9,813,452)
Interest and
Other Income 11,843 322,155 403,843 1,259,692
Net Loss before
Income Tax
Benefit (6,788,680) (3,591,618) (22,589,391) (8,553,760)
Income Tax
(Provision)
Benefit (36,714) (65,302) 234,136 679,454
Net (Loss) Income $(6,825,394) $(3,656,920) $(22,355,255) $(7,874,306)
Net Loss per
Common Share,
Basic and
Diluted $(0.14) (0.07) (0.45) (0.16)
Weighted average
number of common
shares
outstanding 49,893,627 49,878,193 49,886,484 49,877,889
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:
Chau Cheng, Associate Director, Investor
Relations & Business Analysis of Immunomedics, Inc.,
+1-973-605-8200, ext. 123
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