Immunomedics Announces First Quarter Fiscal 2010 Results and Clinical Program Developments

November 06, 2009 --

MORRIS PLAINS, N.J., Nov. 6, 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 first quarter ended September 30, 2009. The Company also highlighted recent key developments and planned activities for its clinical pipeline.

First Quarter Fiscal 2010 Results

The Company reported total revenues of $39.0 million and net income of $32.0 million, or $0.42 per diluted share, for the first quarter of fiscal year 2010, which ended September 30, 2009. This compares to total revenues of $4.9 million and a net loss of $2.2 million, or $0.03 per diluted share, for the same period last year. The increase in revenues for the first quarter of fiscal 2010 was primarily due to the recording of license fee revenue of $31.1 million from the May 2006, development, collaboration and license agreement between the Company and UCB, S.A. In August 2009, the Company received notice from UCB relieving the Company of its responsibilities for the manufacturing of epratuzumab, the only remaining obligation under the UCB agreement, thus allowing the Company to record the full amount of the remaining deferred license fee revenue this quarter. Revenues for the current quarter also included an increase of $3.1 million in license fee revenue from the Company's development, collaboration and license agreement with Nycomed GmbH.

Costs and expenses in the first quarter of fiscal 2010 were $7.3 million, approximately the same as the previous year, as increases of $0.4 million in clinical trial expenses and $0.5 million of research and development expenses, as well as higher headcount and related salaries and employee benefits for the first quarter of 2010 were offset by a $1.4 million expense reimbursement from Nycomed. There was no reimbursement in the comparable quarter last fiscal year.

As of September 30, 2009, the Company had $20.2 million in cash and cash equivalents and $17.7 million in Auction Rate Securities (ARS). ARS consist of AAA rated student loan auction rate securities that currently have no liquidity.

"The net income reported this quarter is primarily from an unusual item resulting from recording the balance of the 2006 upfront licensing fee from UCB," commented Gerard G. Gorman, Senior Vice President, Finance and Business Development, and Chief Financial Officer. "UCB is planning a Phase III clinical study of epratuzumab in patients with systemic lupus erythematosus and we are hopeful that epratuzumab will become a viable treatment option for these patients. Another potential pivotal registration study planned for epratuzumab in 2010 is for the treatment of patients with aggressive lymphoma, to be conducted by National Cancer Institute-sponsored study groups. The Company is also continuing discussion with interested parties for project funding for a Phase III registration trial of veltuzumab in follicular, non-Hodgkin's lymphoma," he added.

Key developments this quarter and future planned activities:

Epratuzumab

* UCB is expected to initiate Phase III clinical trial programs,
after end-of-Phase IIb data presentation and consultation
with regulatory authorities in the United States and the European
Union

* Two National Cancer Institute-sponsored study groups (the North
Central Cancer Treatment Group and the East Coast Oncology Group)
are working on the design of a Phase III clinical trial
randomizing patients with aggressive lymphoma to receive
rituximab and chemotherapy with or without epratuzumab

Veltuzumab

* Follow-up results of low-dose veltuzumab for immune
thrombocytopenic purpura will be presented at the 2009 American
Society of Hematology annual meeting on Saturday,
December 5, 2009

* Updated results of subcutaneous therapy of lymphoma with
veltuzumab have been accepted for presentation at the 51st
annual meeting of the American Society of Hematology on Monday,
December 7, 2009

* Nycomed is expected to initiate a Phase II study of subcutaneous
formulation of veltuzumab in patients with rheumatoid arthritis
during the calendar year 2010

* In fiscal year 2010, if project funding has been secured, the
Company plans to initiate a registration trial comparing
veltuzumab plus chemotherapy with rituximab plus chemotherapy in
patients with newly diagnosed follicular lymphoma

Milatuzumab

* The first clinical trial of the doxorubicin conjugate of
milatuzumab is expected to begin patient enrollment in the third
quarter of fiscal year 2010 for the treatment of multiple
myeloma

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, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 141 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 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.

IMMUNOMEDICS, INC.
Condensed Consolidated Balance Sheets

Sept. 30, June 30,
2009 2009
----------- -----------
ASSETS

Current Assets:
Cash and cash equivalents $20,022,694 $27,390,778
Accounts receivable, net of allowance
for doubtful accounts 661,808 702,021
Inventory 296,015 232,920
Other receivables 2,810,183 1,128,835
Prepaid expenses 818,637 375,934
Other current assets 300,449 396,293
----------- -----------
24,909,786 30,226,781

Property and equipment, net 4,963,094 5,079,354
Auction rate securities 17,666,897 17,458,349
Value of life insurance policies 502,428 486,428
Other long-term assets 30,000 30,000

----------- -----------
$48,072,205 $53,280,912
=========== ===========

LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and other accrued expenses 4,836,732 $ 4,746,286
Deferred revenue - current 7,827,600 45,685,385
Other liabilities 899,344 872,700
Stockholders' equity 34,508,529 1,976,541

----------- -----------
$48,072,205 $53,280,912
=========== ===========

Condensed Consolidated Statements of Operations

Three Months Ended
September 30,
2009 2008
------------------------

Revenues:
Product sales 767,454 1,061,835
License fee and other revenues 37,857,785 3,644,000
Research & development 400,059 196,098
----------- -----------
Total Revenues 39,025,298 4,901,933
Costs and Expenses 7,257,263 7,293,794
----------- -----------
Operating Income (Loss) 31,768,035 (2,391,861)
Interest and Other Income 284,540 357,066
----------- -----------
Income (Loss) before Income Tax Expense 32,052,575 (2,034,795)
Income Tax Expense (40,984) (195,831)
----------- -----------
Net Income (Loss) $32,011,591 $(2,230,626)
=========== ===========

Net Income (Loss) per Common Share:
Basic $ 0.43 $ (0.03)
=========== ===========
Diluted $ 0.42 $ (0.03)
=========== ===========

Weighted average number of common
shares outstanding:
Basic 75,174,419 75,107,773
=========== ===========
Diluted 77,107,370 75,107,773
=========== ===========

CONTACT: Immunomedics, Inc.
Dr. Chau Cheng, Associate Director, Investor Relations
& Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com

Page: 1

Related Sites: BN - IBC

Related Newsletters: