updated 5/10/2011 9:15:57 AM ET 2011-05-10T13:15:57

MORRIS PLAINS, N.J., May 10, 2011 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported financial results for the third quarter ended March 31, 2011. The Company also highlighted recent key developments and planned activities for its clinical pipeline.

Third Quarter Fiscal 2011 Results

The Company reported revenues of $1.1 million and a net loss of $7.6 million, or $0.10 per share, for the third quarter of fiscal year 2011, which ended on March 31, 2011. This compares to revenues of $10.7 million and net income of $3.5 million, or $0.05 per share, for the same period last year. The $9.6 million decrease in revenues this quarter was due primarily from $8.9 million decrease in license fee revenues resulting in part from a $5.0 million milestone payment received during the three-month period ended March 31, 2010. There is no similar milestone payment for the current fiscal year. In addition, the previous year's revenues included the recording of $3.9 million in licensing fees from the Nycomed Agreement.  We had completed our obligations under the Agreement and, accordingly, we recorded the final amortization of the upfront fees deferred under this Agreement in fiscal year 2010.

For the first nine months of the 2011 fiscal year, the Company reported revenues of $3.6 million and a net loss of $17.5 million, or $0.23 per share. This compares to revenues of $54.8 million and net income of $36.3 million, or $0.48 per share, for the same period last year. The decrease in revenues is the result of the fact that the current fiscal period does not reflect any license fee revenues from either the UCB Agreement or the Nycomed Agreement, which were $31.2 million and $14.5 million, respectively, for the nine month period ended March 31, 2010. We had completed amortization of the upfront fees under these Agreements in fiscal year 2010. In addition, the previous year's revenues included the receipt of a $5.0 million milestone payment from Nycomed. As of March 31, 2011, the Company had $23.7 million in cash and cash equivalents, which included $9.5 million in proceeds from the sales of the remaining ARS during the current fiscal year.

"The results for the year have exceeded previous years' cash utilization rates due to legal expenses incurred pertaining to the FINRA arbitration hearing related to our ARS during the year," remarked Gerard G. Gorman, Senior Vice President, Finance and Business Development, and Chief Financial Officer. "Operations will continue to be closely monitored at our forecasted levels," Mr. Gorman added.

The Company's key clinical developments and future planned activities:

Clivatuzumab tetraxetan

  • Plans for Phase III trials continue after discussion with the FDA in January 2011, for conducting two study designs proposed for registration trials. A meeting with potential investigators is scheduled next month in Chicago, preceding the American Society of Clinical Oncology annual meeting, to seek their input and recommendations on our trial plans.  The Company will require additional funding in order to move forward with its plan for these Phase III trials.
     
  • An update on the ongoing Phase II study will be reported as an oral presentation at the June 2011, Society of Nuclear Medicine annual meeting.

Veltuzumab

  • Results from the Phase I/II study of subcutaneous veltuzumab in non-Hodgkin's lymphoma have been published (Haematologica. 2011 Apr;96(4):567-73. Epub 2010 Dec 20).
     
  • Nycomed continues with their planned Phase II dose-ranging study of subcutaneous veltuzumab in rheumatoid arthritis with the first patient anticipated to be enrolled during the first half of calendar year 2011.

Labetuzumab-SN-38

  • The IND for studies with this new antibody-drug conjugate in colorectal cancer was accepted by FDA.  A Phase I dose-escalation trial is expected to begin patient enrollment at the Memorial Sloan-Kettering Cancer Center in the first quarter of calendar year 2012.

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, cytokines 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 175 patents issued in the United States and more than 400 foreign patents, 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
 
      March 31,  June 30,
      2011 2010
ASSETS        
Current Assets:        
Cash and cash equivalents      $ 23,701,723  $ 29,533,230
Auction rate securities - current      --   957,000
Accounts receivable, net of allowance for doubtful accounts      706,063  428,574
Inventory      299,970  534,709
Other receivables      1,120,332  766,441
Prepaid expenses      702,564  449,809
Other current assets      956,237  329,928
       27,486,889  32,999,691
         
Property and equipment, net      3,631,021  4,327,801
Auction rate securities - non-current      --  8,222,154
Value of life insurance policies      565,625  542,463
Other long-term assets      30,000  30,000
         
       $ 31,713,535  $ 46,122,109
         
LIABILITIES AND STOCKHOLDERS' EQUITY        
Accounts payable and other accrued expenses      $ 5,908,735  $ 4,424,216
Other liabilities      1,059,210  979,278
Stockholders' equity      24,745,590  40,718,615
         
       $ 31,713,535  $ 46,122,109
         
Condensed Consolidated Statements of Operations
 
   Three Months Ended   Nine Months Ended 
   March 31,   March 31, 
   2011   2010   2011   2010 
Revenues:        
Product sales  $ 848,819  969,982  2,707,933  2,648,181
License fee and other revenues  14,350  8,913,800  89,350  50,685,385
Research & development  233,882  810,905  797,116  1,482,506
         
Total Revenues  $ 1,097,051  10,694,687  3,594,399  54,816,072
         
Costs and Expenses  9,109,585  8,505,011  24,823,051  20,237,218
         
Operating Income (Loss)  (8,012,534)  2,189,676  (21,228,652)  34,578,854
         
Interest and Other Income  483,294  406,806  3,851,720  966,238
         
(Loss) Income before Income Tax (Expense) Benefit  (7,529,240)  2,596,482  (17,376,932)  35,545,092
         
Income Tax (Expense) Benefit  (73,910)  873,243  (119,133)  706,587
         
Consolidated Net (Loss) Income  (7,603,150)  3,469,725  (17,496,065)  36,251,679
         
Less Net Loss attributable on noncontrolling interest  (145,944)  --   (145,944)  -- 
Net (Loss) Income attributable to Immunomedics, Inc. stockholders  $ (7,457,206)  $ 3,469,725  $ (17,350,121)  $ 36,251,679
         
Net (Loss) Income per Common Share attributable to Immunomedics, Inc. stockholders:        
Basic  $ (0.10)  $ 0.05  $ (0.23)  $ 0.48
Diluted  $ (0.10)  $ 0.05  $ (0.23)  $ 0.48
         
Weighted average number of common shares outstanding:        
Basic  75,317,976 75,225,668  75,291,963 75,188,779
Diluted  75,317,976 75,757,357  75,291,963 75,817,109
CONTACT: Dr. Chau Cheng
         Director, Investor Relations & Grant Management
         (973) 605-8200, extension 123
         ccheng@immunomedics.com

© Copyright 2012, GlobeNewswire, Inc. All Rights Reserved

Discuss:

Discussion comments

,

Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments

Data: Latest rates in the US

Home equity rates View rates in your area
Home equity type Today +/- Chart
$30K HELOC FICO 5.09%
$30K home equity loan FICO 5.21%
$75K home equity loan FICO 4.67%
Credit card rates View more rates
Card type Today +/- Last Week
Low Interest Cards 13.34%
13.34%
Cash Back Cards 17.82%
17.82%
Rewards Cards 17.07%
17.07%
Source: Bankrate.com