-----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, U2SClrPPo3nxtnb+T8/70Yt05cqGVjPVqGbJk5upL/EKl/OTLJbjMAfNeznsEae+ H9jwvs43rtHBBphr9+7S5A== 0001157523-03-001988.txt : 20030515 0001157523-03-001988.hdr.sgml : 20030515 20030515134703 ACCESSION NUMBER: 0001157523-03-001988 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20030331 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030515 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: 03703204 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 a4397653.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) March 31, 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 and Exhibits (c) Exhibits EXHIBIT NUMBER DESCRIPTION Exhibit 99.1 Press Release dated March 31, 2003 of Progenics Pharmaceuticals, Inc. (the "Company"), announcing its results of operations for the fourth quarter and for the year ended December 31, 2002 (filed herewith). Exhibit 99.2 Press Release dated May 15, 2003 of the Company announcing its results of operations for the first quarter ended March 31, 2003 (filed herewith). Item 9. Regulation FD Disclosure. The information contained in this section is intended to be included under "Item 12. Results of Operations and Financial Condition" and is included under Item 9 in accordance with SEC Release No. 33-8216. On March 31, 2003, the Company issued a press release announcing its results of operations for the fourth quarter and for the year ended December 31, 2002. A copy of the press release is attached as Exhibit 99.1 to this report. On May 15, 2003, the Company issued a press release announcing its results of operations for the quarter ended March 31, 2003. A copy of the press release is attached as Exhibit 99.2 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: May 15, 2003 EX-99 3 a4397653ex991.txt EXHIBIT 99.1 Exhibit 99.1 Progenics Pharmaceuticals Reports Fourth Quarter and Year End Results TARRYTOWN, N.Y.--(BUSINESS WIRE)--March 31, 2003--Progenics Pharmaceuticals, Inc., (Nasdaq: PGNX) today announced its results of operations for the fourth quarter and year ended December 31, 2002. Revenues for the fourth quarter ended December 31, 2002 totaled $2.3 million compared to $1.3 million for the same quarter in 2001. For the year ended December 31, 2002, Progenics reported total revenues of $10.1 million compared to $8.9 million for the comparable period in 2001. Revenues primarily reflect payments received by the Company for contract work performed under a services agreement with PSMA Development Company, LLC (JV), and the Company's collaboration with F. Hoffmann-LaRoche Ltd., its terminated collaboration with Bristol-Myers Squibb Company, and funding from government grants and contracts. In addition, the Company received a $1.6 million payment from an insurance settlement in 2002. The Company's expenses for the fourth quarter of 2002 were $9.7 million compared to $7.1 million for the fourth quarter of 2001. For the year ended December 31, 2002, expenses totaled $34.2 million compared to $23.9 million for year ended December 31, 2001. The primary reason for the increase was additional spending relative to the Company's development programs for methylnaltrexone, increased headcount, its joint venture with Cytogen Corporation to develop in-vivo immunotherapies for prostate cancer, and patent legal expenses. The Company reported a net loss of ($7.0 million) or ($0.56) per share (basic and diluted) for the fourth quarter of 2002, compared to net loss of ($4.5 million) or ($0.36) per share (basic and diluted) for the fourth quarter of 2001. For the year ended December 31, 2002, Progenics reported a net loss of ($20.8 million) or ($1.66) per share (basic and diluted) compared to a net loss of ($1.9 million) or ($0.15) per share (basic and diluted) in 2001. Progenics ended 2002 with $42.4 million in cash, cash equivalents and market securities and $6.5 million in committed government grants. "The year 2002 was one of considerable progress for Progenics Pharmaceuticals," said Ronald J. Prentki, Progenics' President. "We advanced our lead product candidate, methylnaltrexone (MNTX), into phase-3 clinical studies in supportive care. We achieved clinical proof-of-concept for PRO 542, our HIV entry inhibitor, and initiated our clinical program for a therapeutic vaccine for prostate cancer. In 2003, we will move MNTX closer to commercialization pursuing three parallel clinical programs in advanced medical illness, post-operative bowel dysfunction, and chronic opioid use. Now that we have commenced phase-3 clinical trials with MNTX, we are also exploring strategic partnering opportunities for this compound. At the same time, we will advance development of our novel inhibitors of viral entry, agents that we believe represent the next generation of HIV therapeutics. We are also pursuing immunotherapies for prostate cancer and expect to begin clinical trials of a novel therapeutic viral-vector vaccine to prevent relapse of this disease." Company Profile 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. The Company 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. In symptom management and supportive care, therapies are being developed to provide patients with an improved quality of life. Progenics' most clinically advanced product 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. 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. (Financial Tables Follow) CONDENSED STATEMENTS OF OPERATIONS Three Months Year Ended Ended ------------------------------------------------- 12/31/2002 12/31/2001 12/31/2002 12/31/2001 ------------------------------------------------- Contract research and development, JV $1,396,995 $199,123 $5,298,293 $199,123 Contract research and development, other 206,615 193,734 4,916,341 Research grants 900,855 848,651 4,543,505 3,725,375 Product sales 20,770 5,800 49,030 42,800 ------------------------------------------------ Total revenues 2,318,620 1,260,189 10,084,562 8,883,639 ------------------------------------------------ Research and development expense 6,671,231 4,022,284 23,760,544 14,501,400 General and adminstrative 1,875,981 2,337,147 6,484,001 6,499,153 Loss in joint venture 778,066 580,005 2,886,423 2,225,454 Depreciation and amortization 310,764 194,202 1,048,960 707,382 ----------------------------------------------- Total expenses 9,636,042 7,133,638 34,179,928 23,933,389 ----------------------------------------------- Operating loss (7,317,422) (5,873,449)(24,095,366)(15,049,750) Interest income 298,744 1,407,261 1,708,253 3,348,401 Interest expense (1,695) (12,678) (1,695) (48,816) Payment from insurance settlement 1,600,000 Payment from collaborator 9,852,015 ----------------------------------------------- Total other income (expenses) 297,049 1,394,583 3,306,558 13,151,600 ----------------------------------------------- Net (loss) $(7,020,373)$(4,478,866)$(20,788,808)$(1,898,150) ================================================ Net (loss) per share: Basic and diluted $(0.56) $(0.36) $(1.66) $(0.15) ================================================ CONDENSED BALANCE SHEETS December 31, December 31, 2002 2001 ---------------------------------------- Cash, cash equivalents and marketable securities $42,373,774 $ 61,877,149 Accounts receivable 334,006 378,020 Fixed assets, net 3,705,531 2,560,199 Other assets 1,704,610 2,665,881 --------------------------------------- Total assets $48,117,921 $67,481,249 ======================================= Liabilities $2,971,292 $3,135,886 Stockholders' equity 45,146,629 64,345,363 --------------------------------------- Total liabilities and stockholders' equity $48,117,921 $67,481,249 ======================================= 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 they are 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. The Company does not have a policy of updating or revising forward-looking statements, and 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 CONTACT: Progenics Pharmaceuticals, Inc., Tarrytown Richard W. Krawiec, Ph.D. 914/789-2800 rkrawiec@progenics.com EX-99 4 a4397653ex992.txt EXHIBIT 99.2 Exhibit 99.2 Progenics Pharmaceuticals Reports First Quarter 2003 Results TARRYTOWN, N.Y.--(BUSINESS WIRE)--May 15, 2003--Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced its results of operations for the quarter ended March 31, 2003. Revenues for the quarter ended March 31, 2003 totaled $2.2 million compared to revenues of $2.4 million for the same period in 2002. Revenues primarily reflect payments received by the Company for contract work performed under a services agreement with PSMA Development Company, LLC (JV), and funding from government grants and contracts. The Company's expenses for the first quarter of 2003 were $8.6 million, compared to $6.5 million for the first quarter of 2002. The increase in expenditures was attributable to spending relative to the Company's development program for methylnaltrexone, its joint venture with Cytogen Corporation to develop in-vivo immunotherapies for prostate cancer, increased headcount and patent legal expenses. The net loss for the first quarter of 2003 was ($6.1 million), compared to a net loss of ($2.0 million) for the same period in 2002. The net loss per share for the first quarter of 2003 was ($0.48), basic and diluted, compared to a net loss per share of ($0.16), basic and diluted, for the same period of 2002. At the end of the first quarter of 2003, Progenics had $35.6 million in cash, cash equivalents and marketable securities compared to $42.4 million at December 31, 2002. "Already in 2003, we have made significant progress in meeting the research and development goals we established for the year," said Ronald J. Prentki, Progenics' President. "We announced positive results from a phase 2 study of methylnaltrexone (MNTX) for opioid-induced constipation in advanced medical illness. Our phase 3 study in this indication is enrolling patients and is on track to be completed later this year. We also began a phase 2 study of MNTX in post-operative ileus earlier this week. In addition, we are continuing to explore strategic partnering opportunities for MNTX." "In the area of HIV therapy, we reported that patient viruses collected six weeks after treatment initiation with PRO 542 showed no evidence of having developed drug resistance," Prentki continued. "Laboratory studies performed in association with our phase 2 studies of PRO 542 revealed that viral load reduction were highly correlated with viral susceptibility as measured by a new assay. Later this year, we plan to file an Investigational New Drug application for PRO 140, our second HIV entry inhibitor. In April, our scientists identified the receptor the hepatitis C virus uses to infect the liver, thereby discovering a potential new therapeutic target for this disease. We are confident that we be able to meet the aggressive goals we have set for the Company this year." Company Profile 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. The Company 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. In symptom management and supportive care, therapies are being developed to provide patients with an improved quality of life. Progenics' most clinically advanced product 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. 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. PROGENICS PHARMACEUTICALS, INC. CONDENSED STATEMENTS OF OPERATIONS Three Months Ended March 31, ----------------------------- 2003 2002 ------------- ------------- (Unaudited) (Unaudited) Contract research and development, joint venture $ 1,052,700 $ 1,007,119 Contract research and development, other 193,734 Research Grants 1,117,418 1,155,798 Product sales 59,566 13,428 ------------- ------------- Total revenues 2,229,684 2,370,079 ------------- ------------- Research and development 5,752,146 4,566,549 General and administrative 1,621,837 1,247,170 Loss in joint venture 879,641 502,319 Depreciation and amortization 303,931 201,938 ------------- ------------- Total expenses 8,557,555 6,517,976 ------------- ------------- Operating loss (6,327,871) (4,147,897) ------------- ------------- Other income (expenses): Interest income 224,126 546,882 Payment from insurance settlement 1,600,000 ------------- ------------- Total other income (expense) 224,126 2,146,882 ------------- ------------- Net loss $ (6,103,745) $ (2,001,015) ============= ============= Net loss per share - basic and diluted $ (0.48) $ (0.16) ============= ============= CONDENSED BALANCE SHEETS March 31, December 31, 2003 2002 ------------- ------------- (Unaudited) (Unaudited) Cash, cash equivalents and marketable securities $ 35,555,040 $ 42,373,774 Accounts receivable 378,461 334,006 Fixed assets, net 3,799,073 3,705,531 Other assets 1,838,220 1,704,610 ------------- ------------- Total assets $ 41,570,794 $ 48,117,921 ============= ============= Liabilities $ 2,004,332 $ 2,971,292 Stockholders' equity 39,566,462 45,146,629 ------------- ------------- Total liabilities and stockholders' equity $ 41,570,794 $ 48,117,921 ============= ============= Disclosure Notice: The information contained in this document is as of May 15, 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 they are 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 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. CONTACT: Progenics Pharmaceuticals, Inc., Tarrytown Richard W. Krawiec, 914/789-2800 E-mail: rkrawiec@progenics.com -----END PRIVACY-ENHANCED MESSAGE-----