-----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, PYRYTeCH7oA9XFMyx04s409uqu0OB6xFmECBjFtO3B4Y3S2Dq30rDteeYa0k1Da/ OXkBKVntf3YfUVnrXCciVg== 0001157523-03-003462.txt : 20030730 0001157523-03-003462.hdr.sgml : 20030730 20030730103627 ACCESSION NUMBER: 0001157523-03-003462 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030730 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030730 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PROGENICS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000835887 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133379479 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23143 FILM NUMBER: 03810300 BUSINESS ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 BUSINESS PHONE: 9147892800 MAIL ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 8-K 1 a4444589.txt PROGENICS PHARMACEUTICALS 8-K 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) July 30, 2003 ------------- Progenics Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 000-23143 13-3379479 ---------------------------- ---------- ---------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 777 Old Saw Mill River Road, Tarrytown, New York 10591 ------------------------------------------------- ------ (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (914) 789-2800 -------------- ------------------------------------------------------------ (Former name or former address, if changed since last report.) Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. (c) Exhibits EXHIBIT NUMBER DESCRIPTION Exhibit 99.1 Press Release dated July 30, 2003 of Progenics Pharmaceuticals, Inc. (the "Company") announcing its results of operations for the second quarter ended June 30, 2003 and first half of 2003 (filed herewith). Item 12. Results of Operations and Financial Condition. On July 30, 2003, the Company issued a press release announcing its results of operations for the second quarter ended June 30, 2003 and first half of 2003. A copy of the press release is attached as Exhibit 99.1 to this report. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. PROGENICS PHARMACEUTICALS, INC. By: /s/ PHILIP K. YACHMETZ ------------------------------------------------- Philip K. Yachmetz Vice President, General Counsel and Secretary Date: July 30, 2003 EX-99 3 a4444589ex99.txt EXHIBIT 99.1 PRESS RELEASE Exhibit 99.1 Progenics Pharmaceuticals Reports Second Quarter 2003 Results; Company awarded $7.7 million in grants from National Institutes of Health TARRYTOWN, N.Y.--(BUSINESS WIRE)--July 30, 2003--Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its results of operations for the second quarter ended June 30, 2003 and first half of 2003. Revenues for the second quarter ended June 30, 2003 totaled $1.9 million compared to $2.7 million for the same quarter in 2002. For the first half of 2003, Progenics reported revenues of $4.2 million compared to $5.0 million for the comparable period in 2002. Revenues primarily reflect funding received by the Company from government grants and contracts and for research and development services rendered to its joint venture with Cytogen Corporation. The Company's expenses for the second quarter of 2003 were $9.9 million compared to $8.5 million for the second quarter of 2002. For the six months ended June 30, 2003, expenses totaled $18.5 million compared to $15.0 million for the six months ended June 30, 2002. The increase in expense is principally due to an increase in headcount, related laboratory supplies, and increased clinical trial activity. The net loss for the second quarter of 2003 was $7.8 million, compared to a net loss of $5.4 million for the same period in 2002. The net loss per share for the second quarter of 2003 was $0.61, basic and diluted, compared to a net loss per share of $0.43 basic and diluted, for the same period of 2002. The net loss for the first half of 2003 was $13.9 million, compared to a net loss of $7.4 million for the same period in 2002. The net loss per share for the first half of 2003 was $1.09, basic and diluted, compared to a net loss per share of $0.59, basic and diluted, for the same period of 2002. The Company ended the second quarter of 2003 with cash, cash equivalents and marketable securities of $29.8 million. The Company also announced that it has been awarded five grants totaling approximately $7.7 million from the National Institutes of Health. The funding comes in the form of three Phase I Small Business Innovation Research (SBIR) grants: two for novel cancer immunotherapies and one for hepatitis C viral entry inhibition, plus two Phase II SBIR grants for development and production of entry inhibitors to the human immunodeficiency virus, the causative agent of AIDS. The Company continues to be successful in its strategy of seeking and securing government grants as an important source of funding for its early-stage research and development programs. "In the second quarter of 2003, we made significant progress in the clinical programs for our lead product candidate, methylnaltrexone," said Ronald J. Prentki, Progenics' President. "At the annual meeting of the American Society of Clinical Oncology, we presented encouraging clinical findings regarding methylnaltrexone's use in treating opioid-induced constipation in patients with advanced medical illness, and we initiated a phase 2 clinical study in post-operative ileus. We also took actions to strengthen the financial position of the company, including successfully securing government grants which will provide for continued support of research and development programs. In addition, we filed a shelf registration statement with the SEC which will allow us to raise addition capital to advance our clinical programs and pursue new programs on an opportunistic basis." The Company's major accomplishments during the last quarter included: -- At the 40th Annual Meeting of the American Society of Clinical Oncology, we presented positive results from a phase 2 clinical trial of our investigational drug, methylnaltrexone (MNTX), for the treatment of opioid-induced constipation in patients with advanced medical illness (AMI). These findings confirmed and extended the top-line results from a study that we reported earlier in the quarter. MNTX restored a more regular bowel movement schedule in opioid-treated patients. At active doses, MNTX induced bowel movements, typically within one hour, in a majority of severely constipated patients. Laxation was achieved without reversing the beneficial effects of the opioids and without any significant adverse side effects. Currently, there is no effective therapy for opioid-induced constipation. MNTX is being evaluated in an ongoing phase 3 clinical trial in AMI that began late last year. -- A phase 2 clinical trial of MNTX was initiated for post-operative ileus (POI), a paralysis of the gastrointestinal tract that often occurs after surgery. There is no approved treatment for POI, a debilitating condition that contributes to prolonged hospital stays and increased healthcare costs. -- New clinical findings showed that MNTX stimulated gastrointestinal motility in the absence of opioids, suggesting that in addition to potential utility in post-operative ileus and opioid-induced constipation, MNTX may be useful in other disorders of impaired bowel motility. -- Progenics' scientists announced the discovery of how the hepatitis C virus (HCV) specifically targets the liver and identified inhibitors that may block HCV infection. Preventing HCV from binding to receptors on liver cells represents a new strategy for treating this serious disease. Progenics Pharmaceuticals, Inc. of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. In symptom management and supportive care, therapies are being developed to provide patients with an improved quality of life. Progenics' most clinically advanced product candidate is methylnaltrexone, a compound in phase 3 clinical testing that is designed to block the debilitating side effects of opioid analgesics without interfering with pain palliation and in phase 2 clinical trials to treat post operative ileus. The Company also applies its expertise in immunology and molecular biology to develop biopharmaceuticals to fight viral diseases, such as human immunodeficiency virus (HIV) infection, and cancers, including malignant melanoma and prostate cancer. The Company is conducting multi-dose phase 2 clinical trials with its lead HIV product, PRO 542, a viral-entry inhibitor and is in preclinical development with PRO 140 and other follow-on product candidates in HIV infection. The Company is developing cancer immunotherapies based on PSMA (prostate-specific membrane antigen) technology and currently is conducting phase 1 clinical studies of a therapeutic prostate cancer vaccine. GMK is a cancer vaccine in phase 3 clinical trials for the treatment of malignant melanoma. DISCLOSURE NOTICE: The information contained in this document is current as of July 30, 2003. This press release contains forward-looking statements. Any statements contained herein that are not statements of historical fact may be forward-looking statements. When the Company uses the words 'anticipates,' 'plans,' 'expects' and similar expressions, it is identifying forward-looking statements. Such forward-looking statements involve risks and uncertainties which may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. Such factors include, among others, the uncertainties associated with product development, the risk that clinical trials will not commence when or proceed as planned, the risks and uncertainties associated with dependence upon the actions of the Company's corporate, academic and other collaborators and of government regulatory agencies, the risk that products that appear promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the uncertainty of future profitability and other factors set forth more fully in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2002 and other periodic filings with the Securities and Exchange Commission to which investors are referred for further information. In particular, the Company cannot assure you that any of the their programs will result in a commercial product. Progenics does not have a policy of updating or revising forward-looking statements and assumes no obligation to update any forward-looking statements contained in this document as a result of the new information or future events or developments. Thus it should not be assumed that the Company's silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. Editor's Note: Additional information on Progenics is available at http://www.progenics.com (Financial Tables Follow) PROGENICS PHARMACEUTICALS, INC. CONDENSED STATEMENTS OF OPERATIONS Three Months Ended Six Months Ended ------------------------------------------------ 6/30/2003 6/30/2002 6/30/2003 6/30/2002 ----------- ----------- ------------ ----------- Contract research and development from JV $ 849,913 $ 1,077,137 $ 1,902,613 $ 2,084,256 Other contract research and development 193,734 Research grants 1,048,115 1,570,823 2,165,533 2,726,621 Product sales 27,325 5,911 86,891 19,339 ----------- ----------- ------------ ----------- Total revenues 1,925,353 2,653,871 4,155,037 5,023,950 ----------- ----------- ------------ ----------- Research and development expense 6,219,784 5,865,977 11,971,930 10,432,526 General and administrative 2,307,307 1,762,019 3,927,449 3,009,189 Loss in joint venture 1,085,959 606,106 1,965,600 1,108,425 Depreciation and amortization 309,544 247,360 613,475 449,298 ----------- ----------- ------------ ----------- Total expenses 9,922,594 8,481,462 18,478,454 14,999,438 ----------- ----------- ------------ ----------- Operating loss (7,997,241) (5,827,591) (14,323,417) (9,975,488) Other income (expense): Interest income 158,065 472,465 382,191 1,019,347 Interest expense (2,825) (4,520) Payment from insurance settlement 1,600,000 ----------- ----------- ------------ ----------- 155,240 472,465 377,671 2,619,347 Net loss $(7,842,001)$(5,355,126)$(13,945,746)$(7,356,141) =========== =========== ============ =========== Net loss per share, basic and diluted $ (0.61)$ (0.43)$ (1.09)$ (0.59) =========== =========== ============ =========== CONDENSED BALANCE SHEETS June 30, 2003 December 31, 2002 ------------- ----------------- Cash, cash equivalents and marketable securities $29,794,579 $ 42,373,774 Accounts receivable 18,162 334,006 Fixed assets, net 3,778,470 3,705,531 Other assets 1,250,088 1,704,610 ----------- ------------ Total assets $34,841,299 $ 48,117,921 =========== ============ Liabilities $ 2,451,285 $ 2,971,292 Stockholders' equity 32,390,014 45,146,629 ----------- ------------ Total liabilities and stockholders' equity $34,841,299 $ 48,117,921 =========== ============ CONTACT: Progenics Pharmaceuticals, Inc. Richard W. Krawiec, Ph.D. 914-789-2800 rkrawiec@progenics.com -----END PRIVACY-ENHANCED MESSAGE-----