Progenics Pharmaceuticals Reports Fourth Quarter and Year End Results

Progenics Pharmaceuticals Reports Fourth Quarter and Year End Results

    Business Editors/Health Editors
    BIOWIRE2K

    TARRYTOWN, N.Y.--(BUSINESS WIRE)--March 16, 2005--Progenics Pharmaceuticals, Inc., (Nasdaq: PGNX) today announced its results of operations for the fourth quarter and year ended December 31, 2004.
    Revenues for the fourth quarter ended December 31, 2004 totaled $3.3 million compared to $2.1 million for the same quarter in 2003. For the year ended December 31, 2004, Progenics reported total revenues of $9.6 million compared to $7.5 million for the comparable period in 2003. Revenues primarily reflect payments received by the Company for contract work performed for PSMA Development Company LLC, the Company's joint venture regarding PSMA technology, and funding from government grants and contracts. The Company's expenses for the fourth quarter of 2004 were $13.8 million compared to $11.9 million for the fourth quarter of 2003. For the year ended December 31, 2004, expenses totaled $52.3 million compared to $39.1 million for year ended December 31, 2003. The primary reason for the increase was additional spending relative to the Company's development programs for methylnaltrexone, increased headcount, patent and legal expenses.
    The Company reported a net loss of ($10.3 million) or ($0.60) per share (basic and diluted) for the fourth quarter of 2004, compared to net loss of ($9.7 million) or ($0.66) per share (basic and diluted) for the fourth quarter of 2003. For the year ended December 31, 2004, Progenics reported a net loss of ($42.0 million) or ($2.48) per share (basic and diluted) compared to a net loss of ($31.0 million) or ($2.32) per share (basic and diluted) in 2003. Progenics ended 2004 with $31.2 million in cash, cash equivalents and marketable securities.
    "Over the past 12 months, Progenics Pharmaceuticals has made significant strides in research and clinical development of our lead product candidates as the Company advances closer to our goal of bringing our first product to market," said Paul J. Maddon, M.D., Ph.D., Progenics' founder and CEO.

    MNTX

--	We achieved positive top-line results from a pivotal phase 3 clinical trial of our lead product candidate, methylnaltrexone (MNTX) for the treatment of opioid-induced constipation in patients with advanced medical illness (AMI). MNTX induced laxation within four hours at more than four times the rate of placebo. On average, laxation occurred within about one hour in the MNTX-treated patients. These results were highly statistically significant, and the drug was generally well tolerated.
--	We also announced positive top-line results from a phase 2 clinical trial of MNTX for the management of post-operative bowel dysfunction. Patients who received MNTX following major abdominal surgery exhibited an acceleration of gastrointestinal recovery by approximately one day on average compared to placebo. Significant improvements were seen in clinically important measures of gastrointestinal recovery: time to first bowel movement and discharge eligibility from the hospital. MNTX was generally well tolerated in this study, with no reports of serious adverse events related to the drug.
--	We completed phase 1 clinical trials of oral formulations of MNTX. Analysis of data from 61 healthy volunteers who received study medication at three dose levels indicated that the drug was well tolerated and exhibited predictable pharmacokinetics.

    HIV

    -- We initiated phase 1 clinical trials of a new HIV therapy - a
    humanized monoclonal antibody to block infection by inhibiting
    the ability of the virus to enter healthy cells. PRO 140 is a
    viral-entry inhibitor that is designed to prevent HIV from
    gaining access to cells of the immune system. Unlike currently
    approved therapies, PRO 140 blocks the CCR5 coreceptor, one of
    the principal portals HIV uses to enter cells. The role of
    CCR5 in HIV infection was discovered in 1996 by Progenics'
    scientists and their collaborators.

    -- In animal testing, our HIV vaccine candidate, ProVax,
    stimulated the production of specific anti-HIV antibodies.
    When tested in the laboratory, these antibodies inactivated
    certain strains of HIV isolated from infected patients. The
    vaccine-elicited antibodies rendering the virus non-infectious
    - a critical step in preventing the establishment of HIV
    infection after initial exposure. Such neutralizing antibodies
    against HIV have been difficult to induce with vaccines
    currently in development.

    PSMA

    -- We were awarded grants totaling $8.0 million over four years
    from the National Institutes of Health to develop novel
    immunotherapies for prostate cancer based on prostate-specific
    membrane antigen (PSMA), a promising cancer target. One grant
    for $3.8 million was awarded to fund the development and
    clinical testing of a fully human monoclonal antibody directed
    to PSMA for the treatment of metastatic prostate cancer. An
    additional grant for $3.6 million was awarded to fund the
    continued development of a recombinant soluble PSMA vaccine.
    The vaccine is designed to enable a patient's immune system to
    recognize prostate cancer cells as foreign and to eliminate
    them. Finally, a third grant for $0.6 million, payable over
    two years, was awarded to fund continued development of
    PSMA-targeted immunotoxins.

    -- PSMA Development Company LLC, our 50/50 joint venture with
    Cytogen Corporation, announced that its recombinant soluble
    PSMA vaccine generated potent immune responses in preclinical
    animal testing. The ongoing phase 1 clinical trial of this
    therapeutic vaccine is designed to evaluate its safety,
    immunogenicity and immune-stimulating properties. Preliminary
    findings showed that certain prostate cancer patients produced
    anti-PSMA antibodies in response to the vaccine.

    "The Company is seeking to meet an aggressive set of goals for the coming 12 months," added Dr. Maddon.

    MNTX

    -- We anticipate completing the enrollment and data analysis of
    our second phase 3 pivotal clinical study of MNTX for the
    treatment of opioid-induced constipation in patients with AMI
    and file a New Drug Application with the Food and Drug
    Administration (FDA) for this indication.

    -- After meeting with FDA, we intend to initiate a phase 3
    clinical study of MNTX in post-operative bowel dysfunction.

    -- We are also preparing to initiate a phase 2 trial of an oral
    formulation of MNTX for opioid-induced constipation in chronic
    pain patients.

    -- To maximize the commercial potential of MNTX, we are working
    towards completing a collaboration with one or more potential
    partners.

    HIV

    -- PRO 542, which is designed to block HIV attachment to immune
    system cells, is expected to complete a multi-dose phase 2
    clinical study. PRO 140, an inhibitor of HIV binding to the
    CCR5 receptor, is scheduled to complete phase 1 studies.

    PSMA

    -- We plan to complete a phase 1 clinical trial of a novel
    recombinant soluble vaccine that targets PSMA, a promising
    cancer marker. A PSMA viral-vector vaccine and monoclonal
    antibodies are completing preclinical testing.

    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 has five product candidates in clinical development and several others in preclinical development. In symptom management and supportive care, the Company is developing methylnaltrexone (MNTX) to treat the constipation associated with opioid-based pain relievers without interfering with pain relief. MNTX is in pivotal phase 3 clinical testing for treatment of opioid-induced constipation in patients with advanced medical illness. MNTX is also being studied for the management of post-operative bowel dysfunction and relief of opioid-induced constipation in patients with chronic pain. In the area of HIV infection, the Company is developing viral-entry inhibitors, including PRO 542, a genetically engineered molecule designed to selectively target and neutralize HIV (in phase 2 studies), and PRO 140, a humanized monoclonal antibody targeting the HIV coreceptor CCR5 (in phase 1 studies). In addition, the Company is conducting research on ProVax, a novel prophylactic HIV vaccine. The Company, in collaboration with Cytogen Corporation, is developing immunotherapies for prostate cancer, including a human monoclonal antibody directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. The Company is also developing vaccines designed to stimulate an immune response to PSMA. A recombinant PSMA vaccine is in phase 1 clinical testing. The Company is also developing a cancer vaccine, GMK, in phase 3 clinical trials for the treatment of malignant melanoma.

    DISCLOSURE NOTICE: The information contained in this document is current as of March 16, 2005. 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 or proceed as planned, the risks and uncertainties associated with dependence upon the actions of our corporate, academic and other collaborators and of government regulatory agencies, the risk that our licenses to intellectual property may be terminated because of our failure to have satisfied performance milestones, the risk that products that appear promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that we may not be able to manufacture commercial quantities of our products, 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, 2003 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2004 and other reports filed with the Securities and Exchange Commission, to which investors are referred for further information. In particular, the Company cannot assure you that any of its 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

CONDENSED STATEMENTS OF OPERATIONS (in thousands, except for loss per share data) (unaudited)

Three Months Ended Year Ended ----------------------------------------------- 12/31/2004 12/31/2003 12/31/2004 12/31/2003 ----------- ----------- ----------- ----------- Contract research and development, JV $ 818 $ 444 $ 2,008 $ 2,486 Research grants and contracts 2,440 1,596 7,483 4,826 Product sales 34 51 85 149 ----------- ----------- ----------- ----------- Total revenues 3,292 2,091 9,576 7,461 ----------- ----------- ----------- -----------

Research and development expense 9,118 9,072 36,063 27,241 General and administrative 3,312 2,004 12,580 8,029 Loss in joint venture 772 533 2,134 2,525 Depreciation and amortization 550 318 1,566 1,273 ----------- ----------- ----------- ----------- Total expenses 13,752 11,927 52,343 39,068 ----------- ----------- ----------- -----------

Operating loss (10,460) (9,836) (42,767) (31,607)

Other income 179 118 749 621 ----------- ----------- ----------- ----------- Net (loss) $ (10,281)$ (9,718)$ (42,018)$ (30,986) =========== =========== =========== =========== Net (loss) per share: Basic and diluted $ (0.60)$ (0.66)$ (2.48)$ (2.32) =========== =========== =========== ===========

CONDENSED BALANCE SHEETS (in thousands) (unaudited)

12/31/2004 12/31/2003 ------------------- ------------------- Cash, cash equivalents and marketable securities $ 31,207 $ 65,663 Accounts receivable 1,112 791 Fixed assets, net 4,692 3,891 Other assets 2,534 2,541 ------- -------

Total assets $ 39,545 $ 72,886 ======= =======

Liabilities $ 7,707 $ 5,203 Stockholders' equity 31,838 67,683 ------- -------

Total liabilities and stockholders' equity $ 39,545 $ 72,886 ======= =======

--30--SW/ny*

CONTACT: Progenics Pharmaceuticals, Inc. Richard W. Krawiec, Ph.D. VP, Investor Relations and Corporate Communications 914-789-2800 rkrawiec@progenics.com

KEYWORD: NEW YORK INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY EARNINGS SOURCE: Progenics Pharmaceuticals, Inc.

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