EXHIBIT 99.1
IMMUNOMEDICS ANNOUNCES FISCAL 2004 RESULTS
Morris Plains, NJ, September 8, 2004 - 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:
o 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.
o 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
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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
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Condensed Consolidated Statements of Operations
Three Months Ended Year Ended
June 30, June 30,
2004 2003 2004 2003
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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
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