EXHIBIT 99.1
Immunomedics Announces Clinical Updates and Third Quarter Fiscal 2009 Results
MORRIS PLAINS, N.J., May 11, 2009 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today reported financial results for the third quarter ended March 31, 2009. The Company also highlighted recent key developments and planned activities for its clinical pipeline.
"This quarter we and our collaborators have made significant progress with our pipeline of products in clinical development highlighted by the multiple presentations we and our collaborators plan to give at the upcoming annual meeting of the American Society of Clinical Oncology," commented Gerard G. Gorman, Senior Vice President, Finance and Business Development, and Chief Financial Officer. "In addition, our collaborative partner, UCB, has completed enrolling patients into their Phase IIb study of epratuzumab in patients with lupus and results from that study are expected in the first quarter of our fiscal year 2010."
Third Quarter Fiscal 2009 Results
The Company reported revenues of $8.3 million and net income of $0.8 million, or $0.01 per share, for the third quarter of fiscal year 2009, which ended March 31, 2009. This compares to revenues of $0.9 million and a net loss of $8.2 million, or $0.11 per share, for the same period last year. The improvement in revenues for the third quarter of fiscal 2009 was primarily the result of recording $7.3 million of license fee revenue from our Nycomed agreement. We had no license fee revenue for the same period last year. The improvement in net income was primarily due to the increase in license fee revenue and a $1.9 million lower impairment charge on auction rate securities (ARS) in fiscal 2009 as compared to the same period last year.
For the first nine months of the 2009 fiscal year, the Company reported revenues of $21.7 million and net income of $1.4 million, or $0.02 per share. This compares to revenues of $2.7 million and a net loss of $16.0 million, or $0.21 per share, for the same period last year. The improvement in revenues was primarily the result of recording $18.2 million of license fee revenue from our Nycomed agreement. We had no license fee revenue for the same period last year. In addition to the increase in revenue the improvement in net income was also due to the Company recording a lower impairment charge on its ARS. These favorable items were partially offset by the impact of reducing the accrual for executive compensation liability and the benefit from the termination of an executive life insurance agreement, both of which occurred in the previous fiscal year reducing general and administrative expense.
As of March 31, 2009, the Company had $51.0 million in cash, cash equivalents and ARS. ARS, valued at $19.0 million consist of AAA rated student loan auction rate securities that currently have no liquidity.
Key developments this quarter and future planned activities:
Epratuzumab
* UCB has completed patient enrollment for their Phase IIb study in
lupus. Results from that study are anticipated in the first
quarter of fiscal year 2010
* North Central Cancer Treatment Group plans to report final results
from its Phase II study of epratuzumab with rituximab and
chemotherapy in patients with aggressive lymphoma in an oral
presentation at the American Society of Clinical Oncology annual
meeting on Saturday, May 30, 2009
Veltuzumab
* Data from a Phase I study of subcutaneous veltuzumab in B-cell
malignancies will be presented in a poster session at the American
Society of Clinical Oncology annual meeting on Monday, June 1, 2009
* Nycomed is expected to initiate Phase II study of subcutaneous
veltuzumab in patients with rheumatoid arthritis in the first
quarter of fiscal year 2010
* Results of the properties and structure-function relationships of
veltuzumab have been published in Blood
hPAM4
* Yttrium-90-labeled hPAM4 was granted Fast Track designation by the
U.S. Food and Drug Administration for the treatment of patients
with pancreatic cancer
* Results from Phase Ib study in advanced pancreatic cancer patients
will be presented in a poster session at the American Society of
Clinical Oncology annual meeting on Sunday, May 31, 2009
Milatuzumab
* Updated results from the dose-escalation trial in patients with
multiple myeloma will be presented in a poster session at the
American Society of Clinical Oncology annual meeting on Saturday,
May 30, 2009
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company primarily 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. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, preta rgeting methods. We believe that our portfolio of intellectual property, which includes approximately 134 patents issued in the United States and more than 300 other patents issued worldwide, protects our product candidates and technologies. For additional information on us, please visit our website at www.immunomedics.com. The information on our website does not, however, form a part of this press release.
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 (including the timing and amount of contingent payments), forecasts of future operating results, 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), our dependence on our licensing partners for the further development of epratuzumab for autoimmune indications and veltuzumab for non-cancer indications, 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 discus sed 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.
IMMUNOMEDICS, INC.
Condensed Consolidated Balance Sheets
March 31, June 30,
2009 2008
------------- -------------
ASSETS
Current Assets:
Cash and cash equivalents $ 31,962,011 $ 6,132,470
Auction rate securities - current -- 20,050,000
Accounts receivable, net of allowance
for doubtful accounts 742,704 1,057,974
Inventory 294,672 469,964
Other receivables 737,668 169,405
Prepaid expenses 559,658 434,305
Other current assets 39,564 42,630
------------- -------------
34,336,277 28,356,748
Property and equipment, net 5,344,409 5,923,170
Auction rate securities - non current 19,026,659 --
Value of life insurance policy 428,346 420,774
Other long-term assets 30,000 30,000
------------- -------------
$ 59,165,691 $ 34,730,692
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LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT)
Current liabilities $ 4,544,598 $ 4,182,236
Deferred revenue - current 21,812,000 --
Other liabilities 846,056 766,123
Deferred revenue - long term 31,145,385 31,145,385
Stockholders' equity (deficit) 817,652 (1,363,052)
------------- -------------
$ 59,165,691 $ 34,730,692
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Condensed Consolidated Statements of Operations
Three Months Ended Nine Months Ended
March 31, March 31,
2009 2008 2009 2008
--------------------------- ---------------------------
Revenues:
Product
sales $ 829,391 $ 860,006 $ 2,636,742 $ 2,438,732
License fee
and other
revenues 7,272,000 -- 18,237,000 --
Research &
development 208,115 44,762 850,466 248,619
------------- ------------- ------------- -------------
Total
Revenues 8,309,506 904,768 21,724,208 2,687,351
Costs and
Expenses 7,360,071 7,799,155 21,685,811 19,583,832
------------- ------------- ------------- -------------
Operating
Income (Loss) 949,435 (6,894,387) 38,397 (16,896,481)
Interest and
Other Income (110,788) (1,259,928) 327,587 (76,820)
------------- ------------- ------------- -------------
Income (Loss)
before Income
Tax Expense 838,647 (8,154,315) 365,984 (16,973,301)
Income Tax
(Expense)
Benefit (80,684) (1,502) 1,053,014 1,011,040
------------- ------------- ------------- -------------
Net Income
(Loss) $ 757,963 $ (8,155,817) $ 1,418,998 $(15,962,261)
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Net Income
(Loss) per
Common Share:
Basic $ 0.01 $ (0.11) $ 0.02 $ (0.21)
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Diluted $ 0.01 $ (0.11) $ 0.02 $ (0.21)
============= ============= ============= =============
Weighted
average
number of
common shares
outstanding:
Basic 75,137,831 75,107,164 75,120,828 75,088,019
============= ============= ============= =============
Diluted 75,312,831 75,107,164 75,287,604 75,088,019
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CONTACT: Immunomedics, Inc.
Dr. Chau Cheng, Associate Director, Investor Relations &
Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
