Attached files
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| 8-K - PROGENICS FORM 8-K MARCH 15, 2010 - PROGENICS PHARMACEUTICALS INC | form8_kmar152010.htm |
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Contact:
|
Investors:
Dory
A. Kurowski
Director,
Corporate Affairs
(914)
789-2818
dkurowski@progenics.com
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Media:
WeissComm
Partners
Aline
Schimmel
(312)
646-6295
aschimmel@wcgworld.com
|
PROGENICS
ANNOUNCES FOURTH QUARTER
AND
YEAR-END 2009 FINANCIAL RESULTS
Tarrytown, NY, March 15, 2010
– Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its results of
operations for the fourth quarter and year ended December 31, 2009.
Financial
Results
Net loss
for the fourth quarter was $0.6 million or $0.02, basic and diluted, per share,
compared to $14.6 million or $0.48, basic and diluted, per share in the fourth
quarter of 2008. Net loss for the year was $30.6 million or $0.98, basic and
diluted, per share, compared to a net loss of $44.7 million or $1.48, basic and
diluted, per share for 2008.
Progenics
ended the year with cash, cash equivalents and marketable securities of $96.2
million, reflecting use of cash of $10.6 million in the fourth quarter and $45.2
million for the full year.
Revenues
for the fourth quarter of 2009 totaled $17.2 million, compared to $6.8 million
for the same period of 2008, reflecting the recognition of the $10.0 million
that Wyeth, now a wholly owned subsidiary of Pfizer, Inc. (NYSE: PFE), agreed to
pay Progenics in connection with termination of their 2005 collaboration and an
increase in amortization of Wyeth’s $60.0 million upfront payment in 2005,
partially offset by a decrease in reimbursement revenue from Wyeth for
RELISTOR®
research and development. For the full year 2009, Progenics reported
revenues of $48.9 million compared to $67.7 million for 2008. Full year 2009
revenues reflect primarily a decrease in reimbursement and milestone revenue
from Wyeth, which was offset by recognition in the fourth quarter of the $10.0
million termination payment and in the first quarter of 2009 of a $15.0 million
upfront payment received in 2008 from Ono Pharmaceutical Co., Ltd. (OSE-TYO:
4528), Progenics’ collaborator for subcutaneous RELISTOR in Japan.
Expenses
for the fourth quarter of 2009 were $17.8 million, compared to $22.6 million for
the same period in the previous year. For the full year 2009, expenses totaled
$81.3 million, compared to $118.6 million for 2008.
The
decreases in expenses for the fourth quarter and year ended December 31, 2009
compared to 2008 were attributable primarily to decreases of $4.1 million and
$34.0 million, respectively, in research and development expenses. The overall
decreases (which were partially offset by increases in PSMA-related clinical
activities) resulted primarily from:
· Reduced
RELISTOR development expenses following completion of Progenics-conducted
clinical trials and other development work; and
· Reduced manufacturing of PRO 140.
Global
net sales of RELISTOR for the fourth quarter of 2009 were $3.9 million, as
compared to $3.3 million in sales for the previous quarter (a 19% increase) and
$1.5 million for the fourth quarter of 2008 (a 158% increase). Of the current
period’s global net sales, U.S. net sales comprised $2.1 million, as compared
with $1.8 million in the previous quarter (a 17% increase) and $0.8 million for
the fourth quarter of 2008 (a 151% increase). Ex-U.S. RELISTOR net sales totaled
$1.8 million in the fourth quarter of 2009, compared to $1.5 million in the
previous quarter (a 21% increase) and $0.7 million in the fourth quarter of 2008
(a 165% increase).
Global
net sales of RELISTOR, which began in June 2008, were $12.3 million for the year
ended December 31, 2009, comprised of $7.1 million of U.S. net sales and $5.2
million of ex-U.S. net sales.
“We have
entered 2010 with rights to the RELISTOR franchise and the ability to map out
the best path forward to advance this important product,” said Paul J. Maddon,
Progenics’ Founder, Chief Executive Officer and Chief Science Officer. “Our
primary objectives this year are to identify a strategic marketing partner for
the RELISTOR franchise, to advance development of the oral formulation, and to
finalize a supplemental New Drug Application for subcutaneous RELISTOR to treat
opioid-induced constipation in the broader chronic-pain patient setting. As we
focus on these priorities, we continue to reduce expenditures and increase
operating efficiencies throughout the organization. We also look forward to
presenting data from the ongoing phase 1 trial of our PSMA ADC candidate for the
treatment of metastatic prostate cancer later this year.”
Fourth
Quarter Highlights
|
·
|
Progenics
and Wyeth terminated their 2005 RELISTOR collaboration, and Progenics
regained all worldwide rights to RELISTOR. Ono Pharmaceutical remains
Progenics’ exclusive licensee for subcutaneous RELISTOR in Japan.
Progenics assumed clinical and non-clinical development responsibilities
for the oral form of RELISTOR and will assume full control of development
and commercialization of subcutaneous RELISTOR upon conclusion of the
transition period. Wyeth agreed to pay Progenics $10.0 million in six
quarterly installments, and to provide support by continuing
manufacturing, marketing, sales, distribution, ongoing clinical studies
and regulatory activities for subcutaneous RELISTOR over the transition
period. Wyeth also committed up to $14.5 million of funding for the
development of a multi-dose pen for subcutaneous RELISTOR and for
pediatric clinical trials. Progenics is considering a range of strategic
alternatives for the future development and commercialization of RELISTOR,
including licensing, collaboration and/or strategic alliances with
world-wide or regional partners.
|
|
·
|
Enrollment
was completed ahead of schedule in a phase 3 one-year, open-label safety
study of subcutaneous RELISTOR in over 1,000 chronic, non-cancer pain
patients. The study, initiated in December 2008 by Wyeth, is designed to
support planned supplemental regulatory filings by early 2011 in the U.S.,
Europe and elsewhere for approval of RELISTOR to treat opioid-induced
constipation (OIC) in the chronic-pain setting. Progenics expects to
present a consolidated safety database from this study and a 470-patient
efficacy study in chronic, non-cancer pain patients (results of which were
announced in May 2009) as part of the
submissions.
|
|
·
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Positive data from a phase 2
study of methylnaltrexone treatment during rehabilitation following
orthopedic procedures was presented at the annual meeting of the American
Academy of Physical Medicine and Rehabilitation. The hypothesis-generating
study was conducted by Progenics in 33 patients and served to evaluate
methylnaltrexone in a new patient setting. Significantly more patients on
study drug experienced laxation within two and four hours compared to
those on placebo (33% versus 0%, [p<0.05] and 39% versus 7%,
[p<0.05], respectively). In addition, the median time to
laxation in the methylnaltrexone group was nearly one day earlier than the
placebo group. Incidences of adverse events were comparable between the
two treatment groups, and no serious adverse events were reported. Data
from this study will support the safety portion of the chronic-pain FDA
filing.
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Recent
Highlights and Updates
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·
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Progenics
announced data from a clinical trial of an oral tablet form of
methylnaltrexone conducted in subjects with chronic, non-cancer pain
receiving various opioid treatment regimens with a history of OIC.
Subjects were administered a single methylnaltrexone tablet at different
dose levels following an overnight fast. Forty-eight percent of subjects
receiving one of the doses (n=25) laxated within four hours of
treatment.
|
|
·
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The
Company announced plans to advance oral methylnaltrexone for the treatment
of OIC into late stage clinical development and will commence a phase 2b/3
clinical trial of a methylnaltrexone tablet in chronic-pain patients in
the second half of 2010. Wyeth has manufactured the tablets to
be used in Progenics’ planned phase 2b/3 trial as provided for under the
provisions of the termination of the collaboration between the two
companies.
|
|
·
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The
Company presented data from preclinical studies of novel multiplex
phosphoinositide 3-kinase (PI3K) inhibitors at the American Association
for Cancer Research’s Conference on Protein Translation and Cancer. In
laboratory studies, these synthetic, small-molecule compounds identified
by Progenics blocked both PI3K, a key regulator of one molecular signaling
pathway, and MNK, an oncogenic kinase in the Ras pathway. Progenics
believes simultaneously blocking these interlinked cellular pathways with
a single agent may provide a strategy to combat some of the most
aggressive forms of cancer.
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-
Financial Tables follow -
|
PROGENICS
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in
thousands, except net loss per share)
|
||||||||||||||||
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For
the Three Months Ended
December
31,
|
For
the Year Ended
December
31,
|
|||||||||||||||
|
2009
|
2008
|
2009
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2008
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|||||||||||||
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Revenues:
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||||||||||||||||
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Research
and development
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$ | 15,145 | $ | 4,989 | $ | 44,351 | $ | 59,885 | ||||||||
|
Royalty
income
|
1,396 | 60 | 2,372 | 146 | ||||||||||||
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Research
grants and contract
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547 | 1,771 | 1,968 | 7,460 | ||||||||||||
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Other
revenues
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67 | 8 | 256 | 180 | ||||||||||||
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Total
revenues
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17,155 | 6,828 | 48,947 | 67,671 | ||||||||||||
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Expenses:
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||||||||||||||||
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Research
and development
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10,775 | 14,099 | 49,798 | 82,290 | ||||||||||||
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License
fees – research and development
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97 | 1,042 | 1,058 | 2,830 | ||||||||||||
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General
and administrative
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5,362 | 6,304 | 25,106 | 28,834 | ||||||||||||
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Royalty
expense
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139 | 6 | 237 | 15 | ||||||||||||
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Depreciation
and amortization
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1,445 | 1,182 | 5,078 | 4,609 | ||||||||||||
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Total
expenses
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17,818 | 22,633 | 81,277 | 118,578 | ||||||||||||
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Operating
loss
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(663 | ) | (15,805 | ) | (32,330 | ) | (50,907 | ) | ||||||||
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Other
income:
|
||||||||||||||||
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Interest
income
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24 | 1,207 | 1,481 | 6,235 | ||||||||||||
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Gain
on sale of marketable securities
|
- | - | 237 | - | ||||||||||||
|
Total
other income
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24 | 1,207 | 1,718 | 6,235 | ||||||||||||
|
Net
loss
|
$ | (639 | ) | $ | (14,598 | ) | $ | (30,612 | ) | $ | (44,672 | ) | ||||
|
Net
loss per share; basic and diluted
|
$ | (0.02 | ) | $ | (0.48 | ) | $ | (0.98 | ) | $ | (1.48 | ) | ||||
|
Weighted
average shares outstanding; basic and diluted
|
31,688 | 30,438 | 31,219 | 30,142 | ||||||||||||
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
(unaudited)
(in
thousands)
|
||||||||
|
December
31, 2009
|
December
31, 2008
|
|||||||
|
Cash,
cash equivalents and marketable securities
|
$ | 96,196 | $ | 141,374 | ||||
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Accounts
receivable
|
7,522 | 1,337 | ||||||
|
Fixed
assets, net
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6,560 | 11,071 | ||||||
|
Other
assets
|
3,335 | 4,051 | ||||||
|
Total
assets
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$ | 113,613 | $ | 157,833 | ||||
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Liabilities
|
$ | 6,006 | $ | 38,464 | ||||
|
Stockholders’
equity
|
107,607 | 119,369 | ||||||
|
Total
liabilities and stockholders’ equity
|
$ | 113,613 | $ | 157,833 | ||||
About
Subcutaneous RELISTOR
RELISTOR
subcutaneous injection is approved in the United States 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. The
use of RELISTOR beyond four months has not been studied. The drug is also
approved for use in over 30 countries worldwide, including the European Union,
Canada, Australia and Brazil. Applications in additional countries are
pending.
Important
Safety Information for RELISTOR
|
·
|
RELISTOR
is contraindicated in patients with known or suspected mechanical
gastrointestinal obstruction.
|
|
·
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If
severe or persistent diarrhea occurs during treatment, advise patients to
discontinue therapy with RELISTOR and consult their
physician.
|
|
·
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Use
of RELISTOR has not been studied in patients with peritoneal
catheters.
|
|
·
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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%).
|
|
·
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RELISTOR
full Prescribing Information for the U.S. is available at
www.relistor.com.
|
Subcutaneous
RELISTOR development in the Chronic-Pain Setting
In May
2009, Progenics and Wyeth reported a positive outcome from a 470-patient, phase
3 efficacy clinical trial in patients with chronic, non-cancer pain. This study
showed statistically significant improvements in the occurrence of bowel
movements with the use of RELISTOR. Adverse events observed in this study were
similar to those seen in prior studies. Enrollment was also recently completed
for phase 3 safety study of over 1,000 patients, with results expected by the
end of 2010. Results from these two studies are expected to be included in an
sNDA submission by early 2011. Subject to FDA approval, Progenics plans to
launch subcutaneous RELISTOR in a multi-dose pen for the chronic-pain OIC market
thereafter.
(PGNX-F)
About
Progenics
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. Principal programs are directed toward supportive
care, oncology and virology. Progenics is developing RELISTOR®
(methylnaltrexone bromide) for the treatment of opioid-induced side effects.
RELISTOR is now approved in over 40 countries, including the U.S., Canada, the
European Union, Latin America countries and Australia. Progenics is pursuing
strategic alternatives for RELISTOR, including licensing, collaboration,
strategic alliances and U.S. commercialization or co-promotion, following
termination of its 2005 collaboration with Wyeth Pharmaceuticals, which is
continuing manufacturing, sales, marketing, and certain development and
regulatory activities for RELISTOR during the transition. Ono Pharmaceutical
Co., Ltd. has an exclusive license from Progenics for development and
commercialization of subcutaneous RELISTOR in Japan. In oncology, the Company is
conducting a phase 1 clinical trial of a human monoclonal antibody-drug
conjugate (ADC) for the treatment of prostate cancer—a selectively targeted
chemotherapeutic antibody directed against prostate-specific membrane antigen.
PSMA is a protein found on the surface of prostate cancer cells as well as in
blood vessels supplying other solid tumors. Progenics is also conducting phase 1
clinical trials with vaccines designed to treat prostate cancer by stimulating
an immune response to PSMA in immunized subjects. Progenics is also developing
novel multiplex PI3-Kinase inhibitors as a potential strategy to combat some of
the most aggressive forms of cancer. In virology, Progenics is developing the
viral-entry inhibitor PRO 140, a humanized monoclonal antibody which binds to
co-receptor CCR5 to inhibit human immunodeficiency virus (HIV) infection. PRO
140 is currently in phase 2 clinical testing. The Company’s hepatitis C virus
discovery program seeks to identify novel inhibitors of HCV entry.
PROGENICS DISCLOSURE NOTICE:
This document contains statements that do not relate strictly to historical
fact, any of which may be forward-looking statements within the meaning of the
U.S. Private Securities Litigation Reform Act of 1995. When we use the words
“anticipates,” “plans,” “expects” and similar expressions, we are identifying
forward-looking statements. Forward-looking statements involve known and unknown
risks and uncertainties which may cause our actual results, performance or
achievements to be materially different from those expressed or implied by
forward-looking statements. While it is impossible to identify or predict all
such matters, these differences may result from, among other things, the
inherent uncertainty of the timing and success of, and expense associated with,
research, development, regulatory approval and commercialization of our products
and product candidates, including the risks that clinical trials will not
commence or proceed as planned; products appearing promising in early trials
will not demonstrate efficacy or safety in larger-scale trials; clinical trial
data on our products and product candidates will be unfavorable; our products
will not receive marketing approval from regulators or, if approved, do not gain
sufficient market acceptance to justify development and commercialization costs;
competing products currently on the market or in development might reduce the
commercial potential of our products; we, our collaborators or others might
identify side effects after the product is on the market; or efficacy or safety
concerns regarding marketed products, whether or not originating from subsequent
testing or other activities by us, governmental regulators, other entities or
organizations or otherwise, and whether or not scientifically justified, may
lead to product recalls, withdrawals of marketing approval, reformulation of the
product, additional pre-clinical testing or clinical trials, changes in labeling
of the product, the need for additional marketing applications, declining sales
or other adverse events.
We
are also subject to risks and uncertainties associated with the actions of our
corporate, academic and other collaborators and government regulatory agencies,
including risks from market forces and trends; potential product liability;
intellectual property, litigation, environmental and other risks; the risk that
we may not be able to enter into favorable collaboration or other relationships
or that existing or future relationships may not proceed as planned; the risk
that current and pending patent protection for our products may be invalid,
unenforceable or challenged, or fail to provide adequate market exclusivity, or
that our rights to in-licensed intellectual property may be terminated for our
failure to satisfy performance milestones; the risk of difficulties in, and
regulatory compliance relating to, manufacturing products; and the uncertainty
of our future profitability.
Risks
and uncertainties also include general economic conditions, including interest
and currency exchange-rate fluctuations and the availability of capital; changes
in generally accepted accounting principles; the impact of legislation and
regulatory compliance; the highly regulated nature of our business, including
government cost-containment initiatives and restrictions on third-party payments
for our products; trade buying patterns; the competitive climate of our
industry; and other factors set forth in our Annual Report on Form 10-K and
other reports filed with the U.S. Securities and Exchange Commission. In
particular, we cannot assure you that RELISTOR will be commercially successful
or be approved in the future in other formulations, indications or
jurisdictions, or that any of our other programs will result in a commercial
product.
We
do not have a policy of updating or revising forward-looking statements and we
assume no obligation to update any statements as a result of new information or
future events or developments. It should not be assumed that our silence over
time means that actual events are bearing out as expressed or implied in
forward-looking statements.
Editors
Note:
For more
information, please visit www.progenics.com.
For more
information about RELISTOR, please visit www.RELISTOR.com.