Immunomedics Announces Second Quarter Fiscal 2010 Results and Clinical Program Developments
Do you know when to trade IMMU ?
Immunomedics, Inc. (Nasdaq: IMMU | Quote | Chart | News | PowerRating), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today reported financial results for the second quarter ended December 31, 2009. The Company also highlighted recent key developments and planned activities for its clinical pipeline.
Second Quarter Fiscal 2010 Results
The Company reported revenues of $5.1 million and net income of $0.8 million, or $0.01 per share, for the second quarter of fiscal year 2010, which ended December 31, 2009. This compares to revenues of $8.5 million and a net income of $2.9 million, or $0.04 per share, for the same period last year. The reduction in revenues for the second quarter of fiscal 2010 was primarily the result of a $3.4 million decrease in license fee revenue from the Company's development, collaboration and license agreement with Nycomed, GmbH, due to a change in the estimated date of completing the Company's obligations under the agreement from December 31, 2009 to March 31, 2010. This was partially offset by increased reimbursements of $1.9 million received from Nycomed, resulting in lower research and development expenses. In the previous year, the Company received $1.4 million from the sale of tax benefits through the New Jersey Technology Tax Certificate Transfer Program. There was no sale of tax benefits during the three-month period ended December 31, 2009. The Company did receive $1.0 million from the State of New Jersey for the sale of tax benefits under this program in January 2010.
For the first half of fiscal year 2010, the Company reported revenues of $44.1 million and net income of $32.8 million, or $0.44 per basic share. This compares to revenues of $13.4 million and net income of $0.7 million, or $0.01 per basic share, for the same period last year. The improvement in revenues was primarily the result of recording $31.1 million of license fee revenue in fiscal 2010 from the May 2006, development, collaboration and license agreement between the Company and UCB, S.A. There was no licensing fee revenue from the UCB agreement recorded in the same period last fiscal year. Net income for the six-month period ended December 31, 2009 was also positively impacted by $2.6 million of reduced research and development expenses, resulting primarily from higher reimbursements from Nycomed.
As of December 31, 2009, the Company had $18.6 million in cash and cash equivalents. In January 2010, the Company received $11.3 million in cash from a $5.0 million milestone payment from Nycomed, $5.3 million in proceeds from the liquidation of two Auction Rate Securities (ARS), and $1.0 million tax benefits from the State of New Jersey. The Company recorded a gain of $0.6 million on the sale of the ARS. The remaining AAA rated student loan ARS valued at $12.5 million currently have no liquidity.
Gerard G. Gorman, Senior Vice President, Finance and Business Development, and Chief Financial Officer stated, "We are pleased to receive our first clinical milestone payment from Nycomed in connection with the study in immune thrombocytopenic purpura, (ITP). Coupled with the cash proceeds from the sale of some of our ARS and the receipt of NOL's, our cash position has been substantially improved." Mr. Gorman added, "We are also pleased that clivatuzumab continues to produce encouraging results in pancreatic cancer, both as a therapeutic agent for patients with advanced stage disease or when used in a diagnostic blood test for detecting early stage cancer, as recently reported at the Gastrointestinal Cancers Symposium. These pathways are part of a three-pronged approach we are developing for the management of pancreatic cancer, which includes early detection and diagnosis with a blood test; a highly sensitive and specific molecular imaging method for locating cancer sites, prior to and following treatment; and using radiolabeled clivatuzumab in combination with gemcitabine for a more selective and personalized therapy of advanced disease." Furthermore, Mr. Gorman stated, "The Company is continuing discussion with interested parties for project funding for a Phase III registration trial of veltuzumab in follicular, non-Hodgkin's lymphoma, which will not be undertaken unless we are able to obtain the additional funding."
Key clinical developments and future planned activities:
Epratuzumab
-- The Company was awarded U.S. patent 7,641,901 covering the use of
epratuzumab and other anti-CD22 antibodies, alone and in combination
with other therapeutics, such as antibodies, cytokines, or drugs, for
the treatment of a wide range of autoimmune diseases that include
systemic lupus erythematosus, rheumatoid arthritis, Sjögren's
syndrome, multiple sclerosis, myasthenia gravis, diabetes mellitus, and
ulcerative colitis
-- UCB has announced they will initiate a Phase III program for epratuzumab
in lupus during calendar year 2010
-- At the 51st Annual Meeting of the American Society of Hematology,
clinical investigators from Mayo Clinic reported results from their
study evaluating the ability of positron-emission tomography to predict
the outcome of patients with diffuse large B-cell lymphoma treated with
epratuzumab in combination with rituximab and CHOP therapy. (Please
refer to www.immunomedics.com/news_pdf/2009_PDF/PR12072009A.pdf for more
information)
-- The Eastern Cooperative Oncology Group, funded primarily by the National
Cancer Institute, is 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 ITP were presented at the
2009 American Society of Hematology annual meeting. (For more
information, please refer to the Company's press release at
www.immunomedics.com/news_pdf/2009_PDF/PR12072009A.pdf)
-- Updated results of subcutaneous therapy of lymphoma with veltuzumab were
presented at the 51st annual meeting of the American Society of
Hematology (Please refer to the Company's press release at
www.immunomedics.com/news_pdf/2009_PDF/PR12082009.pdf for more
information)
-- Nycomed is planning to initiate a Phase II study of subcutaneous
formulation of veltuzumab in patients with rheumatoid arthritis during
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
Clivatuzumab
-- Results from the ongoing Phase I/II study of fractionated
yttrium-90-labeled clivatuzumab tetraxetan in combination with
gemcitabine for patients with inoperable, advanced pancreatic cancer
were presented at the 2010 Gastrointestinal Cancers Symposium of the
American Society of Clinical Oncology. (Please refer to the Company's
press release at www.immunomedics.com/news_pdf/2010_PDF/PR01252010.pdf
for more information)
-- At the same conference, results from initial studies of a new
clivatuzumab-based blood test aimed at identifying patients with
early-stage pancreatic cancer were also presented. (For more
information, please refer to the Company's press release at
www.immunomedics.com/news_pdf/2010_PDF/PR01212010.pdf)
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 145 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
December 31, June 30,
2009 2009
------------ -----------
ASSETS
Current Assets:
Cash and cash equivalents $18,611,045 $27,390,778
Auction rate securities -
current 5,320,000 --
Accounts receivable, net of
allowance for doubtful
accounts 712,878 702,021
Inventory 725,760 232,920
Other receivables 1,350,383 1,128,835
Prepaid expenses 594,070 375,934
Other current assets 207,837 396,293
------------ -----------
27,521,973 30,226,781
Property and equipment, net 4,896,453 5,079,354
Auction rate securities - non
current 12,484,317 17,458,349
Value of life insurance
policies 518,428 486,428
Other long-term assets 30,000 30,000
------------ -----------
$45,451,171 $53,280,912
============ ===========
LIABILITIES AND STOCKHOLDERS'
EQUITY
Accounts payable and other
accrued expenses $4,750,409 $4,746,286
Deferred revenue - current 3,913,800 45,685,385
Other liabilities 925,989 872,700
Stockholders' equity 35,860,973 1,976,541
------------ -----------
$45,451,171 $53,280,912
============ ===========
Condensed Consolidated Statements of Operations
Three Months Ended Six Months Ended
December 31, December 31,
2009 2008 2009 2008
----------- ---------- ------------- ----------
Revenues:
Product sales $910,745 745,516 1,678,199 1,807,351
License fee and other
revenues 3,913,800 7,321,000 41,771,585 10,965,000
Research & development 271,542 446,253 671,601 642,351
----------- ---------- ------------- ----------
Total Revenues $5,096,087 8,512,769 44,121,385 13,414,702
Costs and Expenses 4,474,944 7,031,946 11,732,207 14,325,740
----------- ---------- ------------- ----------
Operating Income (Loss) 621,143 1,480,823 32,389,178 (911,038)
Interest and Other Income 274,892 81,309 559,432 438,375
----------- ---------- ------------- ----------
Income (Loss) before Income
Tax Expense 896,035 1,562,132 32,948,610 (472,663)
Income Tax (Expense)
Benefit (125,672) 1,329,529 (166,656) 1,133,698
----------- ---------- ------------- ----------
Net Income $770,363 $2,891,661 $ 32,781,954 $661,035
=========== ========== ============= ==========
Net Income per Common
Share:
Basic $0.01 $0.04 $0.44 $0.01
=========== ========== ============= ==========
Diluted $0.01 $0.04 $0.43 $0.01
=========== ========== ============= ==========
Weighted average number of
common
shares outstanding:
Basic 75,201,777 75,117,251 75,170,736 75,112,512
=========== ========== ============= ==========
Diluted 76,902,912 75,363,251 76,871,871 75,358,512
=========== ========== ============= ==========
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Immunomedics, Inc.
CONTACT: Immunomedics, Inc. Dr. Chau Cheng, Associate Director, Investor Relations & Business Analysis (973) 605-8200, extension 123 ccheng@immunomedics.com
For full details on Immunomedics Inc (IMMU) IMMU. Immunomedics Inc (IMMU) has Short Term PowerRatings at TradingMarkets. Details on Immunomedics Inc (IMMU) Short Term PowerRatings is available at This Link.
- Immunomedics to Present at Barclays Capital 2010 Global Healthcare Conference - 03/15/10
- Immunomedics Awarded Patents for Antibody for PEGylation and Pretargeting Constructs - 02/23/10
- StockProfiler.US: Medical News Update - 02/22/10
- Immunomedics to Participate in Upcoming Conferences - 02/22/10
- Biopharma Stock Alert for Immunomedics Inc. Issued by Beacon Equity - 02/18/10
- More News >>


