Progenics Pharmaceuticals Announces Third Quarter 2012 Financial Results

Progenics Pharmaceuticals Announces Third Quarter 2012 Financial Results

TARRYTOWN, N.Y., Nov. 8, 2012 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals,
Inc. (Nasdaq:PGNX) today announced its results of operations for the third
quarter and first nine months of 2012.

Net loss for the third quarter of 2012 was $11.3 million or $0.33 basic and
diluted per share, compared to net loss of $11.4 million or $0.34 per share in
the 2011 period. Net loss for the nine months ended September 30, 2012 was
$35.1 million or $1.04 basic and diluted per share, compared to net income of
$21.1 million or $0.63 per share in 2011. The 2011 results reflect recognition
of an upfront payment and development cost reimbursement revenue from the
Salix collaboration. At September 30, 2012, Progenics had cash, cash
equivalents and securities of $44.3 million, reflecting use of $6.7 million in
the quarter.

Third quarter revenue totaled $1.1 million, down $4.7 million from the 2011
period. The decrease reflects a decline in revenue from the Salix
collaboration and lower research grant and royalty revenue. Current quarter
royalty revenue decreased $0.9 million from the previous quarter. For the
first nine months of 2012, Progenics reported revenues of $5.2 million,
compared to $82.6 million in the 2011 period.

Net sales reported by Progenics' Relistor collaborators (in millions):

       Three Months Ended     Nine Months Ended
       September 30, June 30, September 30,
       2012   2011   2012     2012     2011
U.S.    $3.8  $8.2  $ 10.0   $25.1   $13.5
Ex-U.S. 1.1   1.5   0.8     2.9     4.7
Global  $4.9  $9.7  $ 10.8   $28.0   $18.2

Third quarter and year-to-date research and development expenses decreased by
$4.5million and $18.2 million, respectively, compared to the 2011 periods,
primarily from decreased laboratory and manufacturing expenses and lower
salaries and benefits expenses from reduced headcount. Clinical trial expenses
increased in the third quarter compared to the 2011 period while these
expenses decreased year-to-date compared to 2011. Third quarter general and
administrative expenses decreased $0.1 million from 2011, and these expenses
year-to-date decreased $2.5 million from the previous year, primarily
resulting from lower consulting, professional fees and operating expenses.
Company-wide headcount as of September 30, 2012 declined to 78 from 114 as of
September 30, 2011.

Third Quarter and Recent Events

  *As previously announced, on July 27 the FDA issued a Complete Response
    Letter (CRL) requesting additional clinical data for the supplemental New
    Drug Application (sNDA) for Relistor (methylnaltrexone bromide) injection
    for subcutaneous use for the treatment of opioid-induced constipation
    (OIC) in adult patients with chronic, non-cancer pain. On October 5, an
    End-of-Review meeting was held with the FDA's Division of Gastroenterology
    and Inborn Errors Products to better understand the contents of the
    letter. The Division has expressed a concern that there may be a risk
    associated with the chronic use of mu-opioid antagonists in patients who
    are taking opioids for chronic pain. In order to understand this potential
    risk, the FDA's Division has communicated that a very large,
    well-controlled, chronic administration trial will have to be conducted to
    assess the safety of any mu-opioid antagonist prior to market approval for
    the treatment of patients with OIC who are taking opioids for chronic,
    non-cancer pain. Salix has held discussions with the Division and has
    expressed the view that the post-marketing, clinical and preclinical data
    currently available for Relistor adequately demonstrate an appropriate and
    expected safety profile sufficient to permit the approval of the current
    Relistor sNDA.

  Salix and Progenics plan to continue to work with the FDA to generate a
  reasonable path forward for the further development and regulatory review of
  Relistor that can be agreed upon by the parties. While it is not possible to
  determine definitively the duration of discussions with the FDA regarding
  this matter, at this time Salix and Progenics anticipate a path forward
  could be reached with the FDA during 2013.

  *Third quarter Relistor global net sales decreased 50% from third quarter
    2011, and decreased 55% from the second quarter 2012. First nine months
    Relistor global net sales increased 53% over the same 2011 period.
    
  *Progenics opened enrollment in a phase 2 study of its PSMA ADC compound in
    prostate cancer patients. The trial is an open-label, multicenter study to
    assess the anti-tumor activity (measured by prostate specific antigen;
    circulating tumor cells; bone, visceral and nodal metastases; and pain),
    tolerability and safety of PSMA ADC in up to 75 subjects with metastatic
    castration-resistant prostate cancer.
    
  *In a companywide restructuring, the Company reduced its workforce and
    terminated several early stage research projects. Clinical development and
    manufacturing capabilities were unaffected by this restructuring.
    
  *In October, Progenics completed the divestment of the PRO 140 program,
    receiving $3.5 million in cash, together with rights to receive additional
    milestone and royalty payments.

Conference Call and Webcast

Progenics will review third quarter financial results in a conference call
today at 8:30 a.m. EST. To participate, please dial (877) 250-8889 (domestic)
or (720) 545-0001 (international) and reference conference ID 58519374. A live
webcast will be available on the Events section of the Progenics website,
www.progenics.com, and a replay will be available on the website for two
weeks.

                         - Financial Tables follow -

PROGENICS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except net (loss) income per share)

                         For the Three Months Ended For the Nine Months Ended
                          September 30,              September 30,
                         2012          2011         2012          2011
Revenues:                                                       
Royalty income            $ 728         $ 1,240      $ 4,181       $ 1,767
Collaboration revenue     136           2,855        521           76,398
Research grants           243           1,681        417           4,346
Other revenues            10            28           44            88
Total revenues            1,117         5,804        5,163         82,599
                                                               
Expenses:                                                       
Research and development  7,551         12,406       26,417        44,887
License fees – research   510           114          660           566
and development
Royalty expense           73            147          420           274
General and               4,007         4,064        11,753        14,213
administrative
Depreciation and          291           520          1,063         1,581
amortization
Total expenses            12,432        17,251       40,313        61,521
                                                               
Operating (loss) income   (11,315)      (11,447)     (35,150)      21,078
                                                               
Other income:                                                   
Interest income           14            15           43            49
Total other income        14            15           43            49
                                                               
Net (loss) income         $ (11,301)    $ (11,432)   $ (35,107)    $ 21,127
                                                               
Net (loss) income per     $ (0.33)      $ (0.34)     $ (1.04)      $ 0.63
share; basic
Weighted average shares   33,848        33,710       33,803        33,501
outstanding; basic
                                                               
Net (loss) income per     $ (0.33)      $ (0.34)     $ (1.04)      $ 0.63
share; diluted
Weighted average shares   33,848        33,710       33,803        33,664
outstanding; diluted

                                      


CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

                                          September 30, December 31,
                                           2012         2011
                                          (unaudited)   
                                                       
Cash and cash equivalents                  $ 41,096      $ 70,105
Accounts receivable                        1,129         1,516
Auction rate securities                    3,240         3,332
Fixed assets, net                          3,650         4,038
Other assets                               1,386         1,119
Total assets                              $ 50,501      $ 80,110
                                                       
Liabilities                                $ 7,640       $ 7,943
Deferred revenue                           213           366
Total liabilities                          7,853         8,309
Stockholders' equity                       42,648        71,801
Total liabilities and stockholders' equity $ 50,501      $ 80,110

About Relistor

Progenics has exclusively licensed development and commercialization rights
for its first commercial product, Relistor, to Salix Pharmaceuticals, Ltd. for
markets worldwide other than Japan, where Ono Pharmaceutical Co., Ltd. holds
an exclusive license for the subcutaneous formulation. Relistor
(methylnaltrexone bromide) subcutaneous injection is a first-in-class
treatment for opioid-induced constipation approved in more than 50 countries
for patients with advanced illness.

Important Safety Information for subcutaneous Relistor

Relistor is indicated for the treatment of opioid-induced constipation (OIC)
in patients with advanced illness who are receiving palliative care, when
response to laxative therapy has not been sufficient. Use of Relistor beyond
four months has not been studied.

Relistor is contraindicated in patients with known or suspected mechanical
gastrointestinal obstruction. If severe or persistent diarrhea occurs during
treatment, advise patients to discontinue therapy with Relistor and consult
their physician. Use of Relistor has not been studied in patients with
peritoneal catheters.

Safety and efficacy of Relistor have not been established in pediatric
patients.

Rare cases of gastrointestinal (GI) perforation have been reported in advanced
illness patients with conditions that may be associated with localized or
diffuse reduction of structural integrity in the wall of the GI tract (i.e.,
cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying
regions of the GI tract (e.g., stomach, duodenum, colon).

Use Relistor with caution in patients with known or suspected lesions of the
GI tract. Advise patients to discontinue therapy with Relistor and promptly
notify their physician if they develop severe, persistent, and/or worsening
abdominal symptoms.

The most common adverse reactions reported with Relistor compared with placebo
in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs.
5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs.
2.4%), and hyperhidrosis (6.7% vs. 6.5%).

Relistor full Prescribing Information for the U.S. is available at
www.relistor.com.

About Progenics

Progenics Pharmaceuticals, Inc., of Tarrytown, N.Y., is a biopharmaceutical
company dedicated to developing innovative medicines to treat disease, with a
focus on cancer and related conditions. Progenics' pipeline candidates include
PSMA ADC, a human monoclonal antibody-drug conjugate in phase 2 testing for
treatment of prostate cancer, and preclinical stage novel phosphoinositide
3-kinase (PI3K) inhibitors for the treatment of cancer. Progenics has
exclusively licensed development and commercialization rights for its
opioid-induced constipation drug, Relistor, to Salix Pharmaceuticals, Ltd. for
markets worldwide other than Japan, where Ono Pharmaceutical Co., Ltd. holds
an exclusive license for the subcutaneous formulation. Relistor
(methylnaltrexone bromide) subcutaneous injection is a first-in-class
treatment for opioid-induced constipation approved in more than 50 countries
for patients with advanced illness.

The Progenics Pharmaceuticals Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=9678

This press release may contain projections and other forward-looking
statements regarding future events. Such statements are predictions only, and
are subject to risks and uncertainties that could cause actual events or
results to differ materially. These risks and uncertainties include, among
others, the cost, timing and results of clinical trials and other development
activities; the unpredictability of the duration and results of regulatory
review of New Drug Applications and Investigational NDAs; market acceptance
for approved products; generic and other competition; the possible impairment
of, inability to obtain and costs of obtaining intellectual property rights;
and possible safety or efficacy concerns, general business, financial and
accounting matters, litigation and other risks. More information concerning
Progenics and such risks and uncertainties is available on its website, and in
its press releases and reports it files with the U.S. Securities and Exchange
Commission. Progenics is providing the information in this press release as of
its date and does not undertake any obligation to update or revise it, whether
as a result of new information, future events or circumstances or otherwise.

Additional information concerning Progenics and its business may be available
in press releases or other public announcements and public filings made after
this release.

(PGNX-F)

Editors Note:

For more information, please visit www.progenics.com.

For more information about Relistor, please visit www.relistor.com.

CONTACT: Amy Martini
         Corporate Affairs
         (914) 789-2816
         amartini@progenics.com

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