-----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, K0S9EFZg/pyeTl3OBTJBKo0KNk87efS3wdZEmzU8AbqMaID2WZ2HCn2JveUfWpHC umKdgwsf12qWeM+rXTU5zQ== 0001275287-05-004478.txt : 20051107 0001275287-05-004478.hdr.sgml : 20051107 20051107170627 ACCESSION NUMBER: 0001275287-05-004478 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051107 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051107 DATE AS OF CHANGE: 20051107 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: 0825 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-12104 FILM NUMBER: 051184037 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 ii4050.txt FORM 8-K ================================================================================ 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 7, 2005 Immunomedics, Inc. ------------------------------------------------------ (Exact Name of Registrant as Specified in Its Charter) Delaware 000-12104 61-1009366 ---------------------------- ------------ ------------------- (State or Other Jurisdiction (Commission (I.R.S. Employer of Incorporation) File Number) 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 (see General Instruction A.2. below): [ ] 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 7, 2005, Immunomedics, Inc., a Delaware corporation (the "Company"), issued a press release to report the Company's financial results for the quarter ended September 30, 2005. 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. (c) Exhibits: 99.1 Press release of Immunomedics, Inc. dated November 7, 2005, reporting its financial results. * The information in this Form 8-K shall not be deemed to be "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 filing. -2- SIGNATURES 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. Date: November 7, 2005 IMMUNOMEDICS, INC. By: /s/ Cynthia L. Sullivan ------------------------------------- Cynthia L. Sullivan President and Chief Executive Officer -3- EX-99.1 2 ii4050ex991.txt EXHIBIT 99.1 Exhibit 99.1 IMMUNOMEDICS ANNOUNCES FIRST QUARTER FISCAL 2006 RESULTS Morris Plains, NJ, November 7, 2005 - Immunomedics, Inc. (Nasdaq: IMMU), a leading biopharmaceutical company focused on developing monoclonal antibody-based products, today reported revenues of $0.4 million and a net loss of $8.5 million, or $0.16 per share, for the first quarter of fiscal year 2006, which ended September 30, 2005. This compares to revenues of $1.1 million and a net loss of $4.2 million, or $0.08 per share, for the same period last year. Cash used to fund operations for the first three months was $8.9 million as compared to $5.0 million for the same period last year. The increased use of cash of $3.9 million is due primarily to the ALLEVIATE trials evaluating epratuzumab in patients with lupus, and lower sales revenue from diagnostic imaging products. At September 30, 2005, the Company had $20.7 million in cash and marketable securities, in addition to $3.5 million of restricted securities that collateralize the New Jersey Economic Development Authority financing completed in May 2003 for the construction of the Company's expanded manufacturing facilities. "Currently, our highest priority is to successfully complete patient enrollment into our ALLEVIATE trials, to which we will continue to devote resources. While we are placing strong emphasis on a worldwide partnership for the development of epratuzumab in all indications, we have implemented a cost savings program to maintain a burn rate consistent with our available resources," commented Gerard G. Gorman, the Company's Vice President, Finance, and Chief Financial Officer. Salary compensation for the Chairman of the Board & Chief Strategic Officer and certain senior executives will voluntarily be deferred until the Company's financial condition improves as a result of our out-licensing efforts. Additionally, the Company has eliminated certain staff positions and reduced other positions to a part-time basis. The staff reduction program became effective November 1, 2005 and included employee severance costs of approximately $21,000. The Company continues to transition away from the development of diagnostic imaging products toward the accelerated development of therapeutic product candidates. As a result, the Company will no longer commercialize CEA-Scan in the near future. LeukoScan will continue to be manufactured and sold by the Company in territories where regulatory approvals have been granted. "We are proud to be in late-stage clinical testing with epratuzumab in patients with lupus. This market is not only significant in the number of patients but also has a high unmet medical need. Furthermore, the launch of our ALLEVIATE trials has elevated us from an early research and development company to a late-stage development company. Finally, we believe we have also successfully resolved the listing issue with the Nasdaq Stock Market," said Cynthia L. Sullivan, President and Chief Executive Officer of the Company. ~ more ~ On September 2, 2005 the Nasdaq Listing and Qualifications Panel issued a written decision to grant the request by the Company for continued listing on the Nasdaq National Market. In accordance with Nasdaq's procedure, the Nasdaq Listing and Hearing Review Council had 45 calendar days to review the panel decision at their option. The 45-day period has expired without notification from the Nasdaq Stock Market. Consequently, we believe the Company's stock will remain listed on the Nasdaq National Market, subject to our continued compliance with the Nasdaq Stock Market's continued listing requirements. Another development of note during the first quarter of fiscal year 2006 was that the Company and its subsidiary, IBC Pharmaceuticals, Inc., have been awarded two research grants by The National Institutes of Health for the development of an antibody-drug conjugate for the treatment of B-cell malignancies that express the CD74 antigen, and the development of an imaging method based on bispecific antibody pretargeting used in combination with Fluorine-18 labeled peptides. ABOUT IMMUNOMEDICS Immunomedics is a New Jersey-based biopharmaceutical company 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. Our lead product candidate, epratuzumab, is currently in two pivotal Phase III trials for the treatment of patients with moderate and severe lupus (ALLEVIATE A and B). At present, there is no cure for lupus and no new lupus drug has been approved in the U.S. in the last 40 years. We believe that our portfolio of intellectual property, which includes approximately 90 patents issued in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies. Visit our web site at http://www.immunomedics.com. 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, 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), 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. ~ more ~ FOR MORE INFORMATION: Dr. Chau Cheng Associate Director, Investor Relations & Business Analysis (973) 605-8200, extension 123 ccheng@immunomedics.com ### SEPTEMBER 30, June 30, 2005 2005 ------------- ------------- ASSETS CURRENT ASSETS: Cash and cash equivalents............... $ 18,526,227 $ 11,937,483 Marketable securities................... 2,162,457 3,547,507 Accounts receivable..................... 219,464 409,458 Inventory............................... 760,590 493,603 Other current assets.................... 1,273,113 785,677 Restricted securities................... 1,275,200 15,575,200 ------------- ------------- 24,217,051 32,748,928 Property and equipment, net.................. 9,813,194 10,152,115 Restricted securities........................ 2,231,600 2,550,400 Other long-term assets....................... 2,309,909 2,471,706 ------------- ------------- $ 38,571,754 $ 47,923,149 ============= ============= LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities..................... $ 8,364,868 $ 9,422,923 Long-term debt.......................... 36,731,683 36,743,233 Other Liabilities....................... - 2,748,240 Minority interest....................... 247,704 272,160 Stockholders' deficit................... (6,772,501) (1,263,407) ------------- ------------- $ 38,571,754 $ 47,923,149 ============= ============= CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended September 30, ------------------------------- 2005 2004 ------------- ------------- REVENUES: Product sales .......................... 280,074 1,062,693 License fee and other revenues.......... 98,077 52,914 Research & development.................. 44,762 - ------------- ------------- Revenues..................................... 422,913 1,115,607 Costs and Expenses........................... 7,898,863 6,429,803 ------------- ------------- Operating Loss............................... (7,475,950) (5,314,196) Interest and Other Income (Expense).......... (1,067,378) 1,195,624 ------------- ------------- Net Loss before Income Tax Expense .......... (8,543,328) (4,118,572) Income Tax Expense .......................... - (130,088) ------------- ------------- Net Loss .................................... $ (8,543,328) $ (4,248,660) ============= ============= Net Loss per Common Share, Basic and Diluted......................... (0.16) (0.08) ============= ============= Weighted average number of common shares outstanding........................ 54,073,059 52,528,850 ============= ============= -----END PRIVACY-ENHANCED MESSAGE-----