-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VAQjQUU3CjE2HV08+PytufbKAHEVkql99GTmQFwkIjbr5inw+mulsSlLKK3iHc1M t/uaH4vb2yAvbnbbx84X6A== 0001171843-10-002312.txt : 20101104 0001171843-10-002312.hdr.sgml : 20101104 20101104083037 ACCESSION NUMBER: 0001171843-10-002312 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20101104 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101104 DATE AS OF CHANGE: 20101104 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMMUNOMEDICS INC CENTRAL INDEX KEY: 0000722830 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 611009366 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-12104 FILM NUMBER: 101163271 BUSINESS ADDRESS: STREET 1: 300 AMERICAN RD CITY: MORRIS PLAINS STATE: NJ ZIP: 07950 BUSINESS PHONE: 9736058200 MAIL ADDRESS: STREET 1: 300 AMERICAN ROAD CITY: MORRIS PLAINS STATE: NJ ZIP: 07950 8-K 1 document.htm FORM 8-K FILING DOCUMENT Form 8-K Filing

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 8-K


CURRENT REPORT

Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) November 4, 2010  


Immunomedics, Inc.
(Exact name of registrant as specified in its charter)


Delaware
 
000-12104
 
61-1009366
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (IRS Employer Identification No.)


 
300 American Road, Morris Plains, New Jersey
 
07950
 
  (Address of principal executive offices)   (Zip Code)  

Registrant's telephone number, including area code:   (973) 605-8200



Not applicable
(Former name or former address, if changed since last report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
    [    ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
    [    ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
    [    ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
    [    ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02. Results of Operations and Financial Condition.

On November 4, 2010, Immunomedics, Inc., a Delaware corporation (the "Company"), issued a press release to report the Company's financial results for the quarter ended September 30, 2010. The full text of the press release is attached to this current report on Form 8-K as Exhibit 99.1.*

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No. Description

99.1 Press Release of Immunomedics, Inc. dated November 4, 2010 reporting its financial results.




* The information in this Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.


SIGNATURE

    Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

    Immunomedics, Inc.
(Registrant)

November 4, 2010
(Date)
  /s/   CYNTHIA L. SULLIVAN
Cynthia L. Sullivan
President and Chief Executive Officer


  Exhibit Index
  99.1 Press release dated November 4, 2010






EX-99.1 2 newsrelease.htm PRESS RELEASE Immunomedics Announces First Quarter Fiscal 2011 Results and Clinical Program Developments

EXHIBIT 99.1

Immunomedics Announces First Quarter Fiscal 2011 Results and Clinical Program Developments

MORRIS PLAINS, N.J., Nov. 4, 2010 (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 first quarter ended September 30, 2010. The Company also highlighted recent key developments and planned activities for the development of the clinical pipeline.

First Quarter Fiscal 2011 Results

The Company reported total revenues of $1.5 million and a net loss of $6.5 million, or $0.09 per share, for the first quarter of fiscal year 2011, which ended September 30, 2010.  This compares to total revenues of $39.0 million and net income of $32.0 million, or $0.42 per share, for the same period last year. The decrease in revenues this quarter was primarily the result of the recording of $37.9 million of license fee revenues from the UCB and Nycomed Agreements in the first quarter of fiscal year 2010 due to the fact that the Company completed all of its obligations associated with the upfront fees deferred under these agreements. There was no licensing fee revenue recorded in this quarter.  

As of September 30, 2010, the Company had $23.2 million in cash and cash equivalents. On October 29, 2010, the Internal Revenue Service notified the Company that its applications for the certification for qualified investments under the Qualifying Therapeutic Discovery Project Program were approved. Accordingly, the Company will receive an aggregate amount of $2.9 million, most of which is expected to be received during the second quarter of fiscal 2011.

"We are pleased that this quarter we were able to support an aggressive clinical and R&D agenda while maintaining our cash utilization rate at the expected level," commented Gerard G. Gorman, Senior Vice President, Finance and Business Development, and Chief Financial Officer. "As described in our recent R&D day presentation, our main focus is on completing the Phase Ib/II pancreatic cancer trial with clivatuzumab tetraxetan and continuing the enrollment of patients with multiple myeloma into the milatuzumab-doxorubicin study. In addition, we plan to bring a new antibody-drug conjugate involving SN-38, the active metabolite of irinotecan, into clinical testing this fiscal year," he added.

The Company hosted a R&D day on Friday, October 15, 2010, during which outside clinical investigators and Immunomedics' senior management team provided an in-depth discussion of the Company's product pipeline, science and preclinical developments. An archive of the webcast is available for replay via the Investor Relations page on the Company's website at www.immunomedics.com.

Key developments and future planned activities:

Epratuzumab

  • Initial results from Cancer and Leukemia Group B's Phase II study combining epratuzumab and rituximab in patients with previously untreated follicular non-Hodgkin's lymphoma will be reported in an oral presentation at the 2010 American Society of Hematology annual meeting on Monday, December 6, 2010.
     
  • Two Phase III trials, Embody 1 & 2, for epratuzumab in systemic lupus erythematosus are expected to start as planned by UCB by the end of the 2010 calendar year.

Veltuzumab

  • Nycomed is planning to submit regulatory filings for a Phase II study of the subcutaneous formulation of veltuzumab in patients with rheumatoid arthritis during the fourth quarter of calendar year 2010.

Milatuzumab

  • Preliminary results from a Phase I/II study sponsored by Arthur G. James Cancer Hospital and Solove Research Institute at The Ohio State University to evaluate the combination of milatuzumab and veltuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma will be presented at the 2010 American Society of Hematology annual meeting on Sunday, December 5, 2010.

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 proprie tary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 154 patents issued in the United States and more than 375 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 th e 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
 
  September 30,  June 30,
  2010 2010
ASSETS    
Current Assets:    
 Cash and cash equivalents  $ 23,178,760  $ 29,533,230
 Auction rate securities - current  --   957,000
 Accounts receivable, net of allowance for doubtful accounts  1,022,789  428,574
 Inventory  444,048  534,709
 Other receivables  799,747  766,441
 Prepaid expenses  778,177  449,809
 Other current assets  738,447  329,928
   26,961,968  32,999,691
     
Property and equipment, net  4,234,152  4,327,801
Auction rate securities - non-current  8,446,141  8,222,154
Value of life insurance policies  556,472  542,463
Other long-term assets  30,000  30,000
     
   $ 40,228,733  $ 46,122,109
     
LIABILITIES AND STOCKHOLDERS' EQUITY    
 Accounts payable and other accrued expenses  $ 4,263,990  $ 4,424,216
 Other liabilities  1,005,922  979,278
 Stockholders' equity  34,958,821  40,718,615
     
   $ 40,228,733  $ 46,122,109
 
Condensed Consolidated Statements of Operations
 
   Three Months Ended 
   September 30, 
   2010   2009 
     
Revenues:    
 Product sales   1,130,271  767,454
 License fee and other revenues  --  37,857,785
 Research & development  363,550  400,059
     
Total Revenues  1,493,821  39,025,298
     
Costs and Expenses  8,193,686  7,257,263
     
Operating Income (Loss)  (6,699,865)  31,768,035
     
Interest and Other Income   281,238  284,540
     
(Loss) Income before Income Tax Expense   (6,418,627)  32,052,575
     
Income Tax Expense   (46,902)  (40,984)
     
Net (Loss) Income  $ (6,465,529)  $ 32,011,591
     
Net (Loss) Income per Common Share:    
 Basic  $ (0.09)  $ 0.43
 Diluted   $ (0.09)  $ 0.42
     
Weighted average number of common     
 shares outstanding:    
 Basic 75,269,134 75,174,419
 Diluted  75,269,134 77,107,370
CONTACT:  Immunomedics, Inc.
          Dr. Chau Cheng, Director, Investor Relations & Grant
           Management
          (973) 605-8200, extension 123
          ccheng@immunomedics.com
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