Progenics Pharmaceuticals Announces Third Quarter Financial Results
Enrollment Complete in Phase 2 Study of MIP-1404
TARRYTOWN, N.Y., Nov. 11, 2013 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals,
Inc. (Nasdaq:PGNX) today announced its results of operations for the quarter
and nine months ended September 30.
Net loss for the quarter was $10.5 million or $0.17 diluted per share,
compared to net loss of $11.3 million or $0.33 diluted per share in the 2012
period. Net loss for the current nine months was $34.0 million or $0.63
diluted per share, compared to $35.1 million or $1.04 diluted per share in
2012. Progenics ended the quarter with cash, cash equivalents and securities
of $77.8 million, a decrease of $3.6 million for the quarter and an increase
of $15.7 million from 2012 year-end.
Third quarter revenue totaled $0.9 million, down from $1.1 million in 2012.
Nine months 2013 revenue was $4.9 million, down from $5.2 million in the prior
year period. Royalty income for the 2013 and prior year third quarters was
$0.7 million, based on Relistor^® net sales (in millions) reported to
Progenics by Salix, summarized in the table below. Reported global gross sales
for the third quarter were almost flat as compared to the previous quarter,
while global net sales decreased quarter-over-quarter. Salix has attributed
the gross-to-net difference to product returns.
Three Months Ended Nine Months Ended
September 30, June 30, September 30,
2013 2012 2013 2013 2012
U.S. $3.7 $3.8 $6.7 $17.1 $25.1
Ex-U.S. 1.1 1.1 1.2 3.3 2.9
Global $4.8 $4.9 $7.9 $20.4 $28.0
Third quarter research and development expenses totaled $8.1 million, level
with the prior year period. Year-to-date research and development expense
decreased by $0.2 million to $27.3 million, primarily due to lower
compensation expense, partially offset by higher clinical trial expenses for
PSMA ADC and inclusion in 2013 of expenses related to MIP-1404. Third quarter
and year-to-date general and administrative expense decreased by $0.9 million
compared to the prior year periods, primarily due to lower compensation
expense from a third quarter 2012 restructuring, partially offset by higher
consulting and professional fees and other operating expenses.
Third Quarter and Recent Events
*The company completed enrollment in its phase 2 study of MP-1404, a PSMA
*The company presented data on two of its PSMA-focused technologies, at the
European Association of Nuclear Medicine (EANM) Annual Congress in Lyon,
France (October 21), and at the AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics in Boston (October 19 – 23).
*The U.S. Food and Drug Administration plans to convene on March 10-11,
2014 an Advisory Committee to consider Salix's supplemental New Drug
Application (sNDA) for Relistor (methylnaltrexone bromide) Subcutaneous
Injection for opioid-induced constipation in patients with chronic pain.
*Relistor global net sales decreased 39% from the second quarter and 1%
from the third quarter of 2012. Global gross sales were nearly flat as
compared to the second quarter and increased more than 80% versus third
*Progenics completed the sale of an additional 1.275 million shares from
the underwriters' overallotment option in its June follow-on financing,
yielding $5.2 million additional net proceeds.
*Michael D. Kishbauch was elected to the company's board of directors and
Stephen P. Goff, a director since 1993, retired.
Conference Call and Webcast
Progenics will review third quarter financial results in a conference call
today at 8:30a.m. EST. To participate, please dial (877) 250-8889 (domestic)
or (720) 545-0001 (international) and reference conference ID92604931. A live
webcast will be available in the Media Center of the Progenics website,
www.progenics.com, and a replay will be available there for two weeks.
- Financial Tables follow -
PROGENICS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except net loss per share)
For the Three Months Ended For the Nine Months Ended
September 30, September 30,
2013 2012 2013 2012
Royalty income $719 $728 $3,052 $4,181
Collaboration revenue 145 136 1,512 521
Research grants -- 243 275 417
Other revenues 3 10 55 44
Total revenues 867 1,117 4,894 5,163
Research and development 7,913 7,551 26,702 26,417
License fees – research 91 510 314 660
Royalty expense 73 73 308 420
General and 3,123 4,007 10,853 11,753
Depreciation and 179 291 774 1,063
Total expenses 11,379 12,432 38,951 40,313
Operating loss (10,512) (11,315) (34,057) (35,150)
Interest income 12 14 36 43
Total other income 12 14 36 43
Net loss $(10,500) $(11,301) $(34,021) $(35,107)
Net loss per share; basic $(0.17) $(0.33) $(0.63) $(1.04)
Weighted average shares
outstanding; basic and 60,599 33,848 54,104 33,803
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
Cash and cash equivalents $75,597 $58,838
Accounts receivable 754 6,937
Auction rate securities 2,208 3,240
Fixed assets, net 2,526 3,399
Intangible assets and goodwill 40,002 --
Other assets 1,371 3,894
Total assets $122,458 $76,308
Current liabilities $6,072 $8,662
Acquisition-related contingent consideration 15,900 --
Deferred tax and other liabilities 13,598 1,078
Total liabilities 35,570 9,740
Stockholders' equity 86,888 66,568
Total liabilities and stockholders' equity $122,458 $76,308
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
Safety and efficacy of Relistor have not been established in pediatric
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
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
Progenics Pharmaceuticals, Inc. is developing innovative medicines for
oncology, with a pipeline that includes several product candidates in
late-stage clinical development. Progenics' first-in-class PSMA targeted
technology platform includes an antibody drug conjugate therapeutic and a
small molecule targeted imaging agent, both in phase 2 clinical trials. Among
other assets in its pipeline of targeted radiotherapy and molecular imaging
compounds is Azedra^TM, an ultra-orphan radiotherapy candidate also in phase 2
under an SPA. Progenics' first commercial product, Relistor^®
(methylnaltrexone bromide) for opioid-induced constipation, is partnered with
and marketed by Salix Pharmaceuticals, Inc. Ono Pharmaceutical Co. is
developing Relistor in Japan. For additional information, please visit
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
Information on or accessed through our website is not included in the
company's SEC filings.
For more information, please visit www.progenics.com.
For more information about Relistor, please visit www.relistor.com.
CONTACT: Amy Martini
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