Immunomedics Announces Second Quarter Fiscal 2010 Results and Clinical Program Developments

Posted on: Tue, 02 Feb 2010 08:32:54 EST


Symbols: IMMU
MORRIS PLAINS, N.J., Feb 2, 2010 (GlobeNewswire via COMTEX) --

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

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