Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced
financial results and provided a business update for the third
quarter of 2017.
“The recent completion of our NDA submission for
AZEDRA represents a major achievement for our growing company,”
said Mark Baker, Chief Executive Officer of Progenics. “AZEDRA
offers a potentially transformative therapy for metastatic
pheochromocytoma and paraganglioma patients who have no treatment
options in the U.S. for this devastating condition. We are
continuing to build the necessary team and infrastructure to
support a rapid commercial launch of this important therapy
following a potential approval.”
Third Quarter and Recent Key Business
Highlights
AZEDRA, Ultra-Orphan Radiotherapeutic
Candidate
- New Drug Application (NDA) for AZEDRA (iobenguane I
131) Submitted to the U.S. Food and Drug Administration (FDA) on
October 31stAs announced earlier today, Progenics has
submitted the NDA for AZEDRA in patients with malignant, recurrent,
and/or unresectable pheochromocytoma and paraganglioma, rare
neuroendocrine tumors for which there are currently no approved
treatment options in the United States. The NDA remains subject to
FDA regulatory review and approval. AZEDRA holds Breakthrough
Therapy and Orphan Drug statuses, as well as Fast Track
designation.
- Multiple Presentations of Additional Data from Phase 2b
Trial of AZEDRAProgenics has recently presented the
positive results from its pivotal Phase 2b study evaluating AZEDRA
at the 5th International Symposium on Pheochromocytoma and
Paraganglioma (ISP), the North American Neuroendocrine Tumor
Society (NANETS) 2017 Annual Symposium, and the 30th Annual
Congress of the European Association of Nuclear Medicine (EANM).
The Phase 2b trial met the primary endpoint evaluating the
proportion of metastatic pheochromocytoma and paraganglioma
patients who achieved a 50% or greater reduction of all
antihypertensive medications for at least six months. The results
further demonstrated that sustained reduction of antihypertensive
medications was positively correlated with favorable tumor
responses, including radiographic tumor responses, tumor biomarker
response and overall survival. AZEDRA was shown to be safe and
generally well tolerated.
PSMA-Targeted Prostate Cancer Pipeline
- Progress Continues for Clinical Studies of 1404, PyL™
and 1095Progenics continues to enroll patients in: the
Phase 3 trial of 1404, a SPECT/CT imaging agent; the Phase 2/3
study of PyL, a PET/CT imaging agent; and the Phase 1 open-label
dose escalation study of 1095, a radiotherapeutic that selectively
binds to PSMA.
RELISTOR, Treatment for Opioid-Induced
Constipation (partnered with Valeant Pharmaceuticals International,
Inc.)
- Third Quarter 2017 RELISTOR® Net Sales of $17.1
MillionThe third quarter 2017 sales, as reported to
Progenics by its partner Valeant, translated to $2.6 million in
royalty revenue for Progenics for the quarter. Oral RELISTOR
prescriptions increased 40% over the preceding quarter.
Third Quarter 2017 Financial
Results
Third quarter revenue totaled $2.7 million, down
from $53.9 million in the third quarter of 2016, reflecting
RELISTOR royalty income of $2.6 million compared to $3.3 million in
the corresponding period of 2016. The prior year period included
milestone revenue of $50.0 million for the approval of RELISTOR
oral tablets as well as a non-recurring favorable sales return
adjustment included in Valeant’s reported net sales of
RELISTOR.
Third quarter research and development expenses
increased by $0.5 million compared to the corresponding prior year
period, resulting primarily from higher clinical trial costs for
PyL, partially offset by lower manufacturing scale-up costs for
1095. Third quarter general and administrative expenses decreased
by $1.3 million compared to the corresponding prior year period,
which included an accrual for litigation with a former employee.
Partially offsetting this decrease were higher costs associated
with building commercial capabilities in preparation for a
potential AZEDRA approval and launch. For the three months ended
September 30, 2017, Progenics recognized interest expense of $1.0
million related to the RELISTOR royalty-backed loan.
Net loss attributable to Progenics for the third
quarter was $15.4 million, or $0.22 per diluted share, compared to
net income of $36.3 million, or $0.52 per diluted share, in the
corresponding 2016 period. Progenics ended the third quarter with
cash and cash equivalents of $98.3 million, a decrease of $40.6
million compared to cash and cash equivalents as of December 31,
2016.
Conference Call and Webcast
Progenics will review third quarter financial
results in a conference call today at 8:30 a.m. ET. To participate,
please dial (877) 250-8889 (domestic) or (720) 545-0001
(international) and reference conference ID 5589567. A live webcast
will be available in the Media Center of the Progenics website,
www.progenics.com, and a replay will be available for two
weeks.
- Financial Tables follow -
PROGENICS PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except per share data)
|
For the Three Months
EndedSeptember 30, |
For the Nine Months
EndedSeptember 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Revenues: |
|
|
|
|
(Unaudited) |
|
|
|
|
Royalty income |
$ |
2,562 |
|
$ |
3,319 |
|
$ |
7,282 |
|
$ |
7,888 |
|
License revenue |
|
129 |
|
|
50,523 |
|
|
491 |
|
|
56,839 |
|
Other revenues |
|
6 |
|
|
8 |
|
|
36 |
|
|
50 |
|
Total revenues |
|
2,697 |
|
|
53,850 |
|
|
7,809 |
|
|
64,777 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
10,344 |
|
|
9,827 |
|
|
31,641 |
|
|
26,964 |
|
General and
administrative |
|
5,958 |
|
|
7,220 |
|
|
17,986 |
|
|
18,637 |
|
Change in contingent
consideration liability |
|
700 |
|
|
600 |
|
|
3,300 |
|
|
1,400 |
|
Total operating
expenses |
|
17,002 |
|
|
17,647 |
|
|
52,927 |
|
|
47,001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss)
income |
|
(14,305 |
) |
|
36,203 |
|
|
(45,118 |
) |
|
17,776 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense)
income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense)
income, net |
|
(1,047 |
) |
|
79 |
|
|
(3,230 |
) |
|
176 |
|
Total other (expense)
income |
|
(1,047 |
) |
|
79 |
|
|
(3,230 |
) |
|
176 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
(15,352 |
) |
|
36,282 |
|
|
(48,348 |
) |
|
17,952 |
|
Net loss attributable
to noncontrolling interests |
|
- |
|
|
(21 |
) |
|
- |
|
|
(58 |
) |
Net (loss)
income attributable to Progenics |
$ |
(15,352 |
) |
$ |
36,303 |
|
$ |
(48,348 |
) |
$ |
18,010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
income per share attributable to Progenics - basic |
$ |
(0.22 |
) |
$ |
0.52 |
|
$ |
(0.69 |
) |
$ |
0.26 |
|
Weighted
average shares outstanding – basic |
|
70,270 |
|
|
70,013 |
|
|
70,233 |
|
|
69,970 |
|
Net (loss)
income per share attributable to Progenics - diluted |
$ |
(0.22 |
) |
$ |
0.52 |
|
$ |
(0.69 |
) |
$ |
0.26 |
|
Weighted
average shares outstanding –diluted |
|
70,270 |
|
|
70,297 |
|
|
70,233 |
|
|
70,006 |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands) |
|
|
September 30, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
|
(unaudited) |
|
(audited) |
Cash and cash
equivalents |
$ |
98,279 |
$ |
138,909 |
Accounts receivable,
net |
|
2,619 |
|
4,864 |
Property and equipment,
net |
|
4,352 |
|
4,760 |
Intangible assets, net
and goodwill |
|
43,496 |
|
43,655 |
Other assets |
|
4,136 |
|
6,798 |
Total assets |
$ |
152,882 |
$ |
198,986 |
|
|
|
|
|
Current
liabilities |
$ |
13,059 |
$ |
16,357 |
Acquisition-related
contingent consideration liability |
|
17,500 |
|
14,200 |
Long-term debt,
deferred tax and other liabilities |
|
62,243 |
|
63,667 |
Total liabilities |
|
92,802 |
|
94,224 |
Total stockholders’ equity |
|
60,080 |
|
104,762 |
Total liabilities and stockholders’
equity |
$ |
152,882 |
$ |
198,986 |
About RELISTOR®
Progenics has exclusively licensed development
and commercialization rights for its first commercial product,
RELISTOR, to Valeant. RELISTOR Tablets (450 mg once daily) are
approved in the United States for the treatment of opioid-induced
constipation (OIC) in patients with chronic non-cancer pain.
RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for
OIC approved in the United States and worldwide for patients with
advanced illness and chronic non-cancer pain.
IMPORTANT SAFETY
INFORMATION - RELISTOR (methylnaltrexone
bromide) tablets, for oral use and RELISTOR (methylnaltrexone
bromide) injection, for subcutaneous use
RELISTOR tablets and injection are
contraindicated in patients with known or suspected
gastrointestinal obstruction and patients at increased risk of
recurrent obstruction, due to the potential for gastrointestinal
perforation.
Cases of gastrointestinal perforation have been
reported in adult patients with opioid-induced constipation and
advanced illness with conditions that may be associated with
localized or diffuse reduction of structural integrity in the wall
of the gastrointestinal tract (e.g., peptic ulcer disease,
Ogilvie's syndrome, diverticular disease, infiltrative
gastrointestinal tract malignancies or peritoneal metastases). Take
into account the overall risk-benefit profile when using RELISTOR
in patients with these conditions or other conditions which might
result in impaired integrity of the gastrointestinal tract wall
(e.g., Crohn's disease). Monitor for the development of severe,
persistent, or worsening abdominal pain; discontinue RELISTOR in
patients who develop this symptom.
If severe or persistent diarrhea occurs during
treatment, advise patients to discontinue therapy with RELISTOR and
consult their healthcare provider.
Symptoms consistent with opioid withdrawal,
including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety,
and yawning have occurred in patients treated with RELISTOR.
Patients having disruptions to the blood-brain barrier may be at
increased risk for opioid withdrawal and/or reduced analgesia and
should be monitored for adequacy of analgesia and symptoms of
opioid withdrawal.
Avoid concomitant use of RELISTOR with other
opioid antagonists because of the potential for additive effects of
opioid receptor antagonism and increased risk of opioid
withdrawal.
The use of RELISTOR during pregnancy may
precipitate opioid withdrawal in a fetus due to the immature fetal
blood brain barrier and should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Because of the potential for serious adverse reactions, including
opioid withdrawal, in breastfed infants, advise women that
breastfeeding is not recommended during treatment with RELISTOR. In
nursing mothers, a decision should be made to discontinue nursing
or discontinue the drug, taking into account the importance of the
drug to the mother. A dosage reduction of RELISTOR tablets
and RELISTOR injection is recommended in patients with moderate and
severe renal impairment (creatinine clearance less than 60
mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of
RELISTOR tablets or RELISTOR injection is needed in patients with
mild renal impairment.
A dosage reduction of RELISTOR tablets is
recommended in patients with moderate (Child-Pugh Class B) or
severe (Child-Pugh Class C) hepatic impairment. No dosage
adjustment of RELISTOR tablets is needed in patients with mild
hepatic impairment (Child-Pugh Class A). No dosage adjustment of
RELISTOR injection is needed for patients with mild or moderate
hepatic impairment. In patients with severe hepatic impairment,
monitor for methylnaltrexone-related adverse reactions. In the
clinical studies, the most common adverse reactions were:
OIC in adult patients with chronic non-cancer
pain
- RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater
incidence than placebo): abdominal pain (14%), diarrhea (5%),
headache (4%), abdominal distention (4%), vomiting (3%),
hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea
(2%), and chills (2%).
- RELISTOR injection (≥ 1% of RELISTOR patients and at a greater
incidence than placebo): abdominal pain (21%), nausea (9%),
diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and
chills (1%).
OIC in adult patients with advanced illness
- RELISTOR injection (≥ 5% of RELISTOR patients and at a greater
incidence than placebo): abdominal pain (29%) flatulence (13%),
nausea (12%), dizziness (7%), and diarrhea (6%).
Please see complete Prescribing Information for
RELISTOR at www.valeant.com. For more information about
RELISTOR, please visit www.RELISTOR.com.
About ProgenicsProgenics
develops innovative medicines and other technologies to target and
treat cancer. Progenics' pipeline includes: 1) therapeutic agents
designed to precisely target cancer (AZEDRA® and 1095), 2)
PSMA-targeted imaging agents for prostate cancer (1404 and PyL™),
and 3) imaging analysis tools. Progenics' first commercial product,
RELISTOR® (methylnaltrexone bromide) for opioid-induced
constipation, is partnered with Valeant Pharmaceuticals
International, Inc.
This press release may contain projections and
other "forward-looking statements" regarding future events.
Statements contained in this communication that refer to Progenics'
estimated or anticipated future results or other non-historical
facts are forward-looking statements that reflect Progenics'
current perspective of existing trends and information as of the
date of this communication. Forward looking statements generally
will be accompanied by words such as "anticipate," "believe,"
"plan," "could," "should," "estimate," "expect," "forecast,"
"outlook," "guidance," "intend," "may," "might," "will,"
"possible," "potential," "predict," "project," or other similar
words, phrases or expressions. 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
unpredictability of results of clinical trials and other
development activities and collaborations, such as the Phase 3
clinical program for 1404; our ability to successfully develop and
commercialize the products of EXINI Diagnostics AB; the
unpredictability of the duration and results of regulatory review
of New Drug Applications (NDA) and Investigational NDAs, including
our NDA for AZEDRA and related inspections of Progenics’ and its
contract manufacturing organizations’ facilities and other sites
and other requirements that will need to be met before any approval
is obtained; market acceptance for approved products; the
effectiveness of the efforts of our partners to market and sell
products on which we collaborate and the royalty revenue generated
thereby; generic and other competition; the possible impairment of,
inability to obtain and costs of obtaining intellectual property
rights; possible product safety or efficacy concerns, general
business, financial, regulatory 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, including those risk factors included in its
Quarterly Report on Form 10-Q for the quarterly period ended March
31, 2017, as updated in its Quarterly Report on Form 10-Q for the
quarterly period ended June 30, 2017. Progenics is providing the
information in this press release as of its date and, except as
expressly required by law, Progenics disclaims any intent or
obligation to update or revise any forward-looking statements,
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. For more
information, please visit www.progenics.com. Please follow us on
LinkedIn®. Information on or accessed through our website or social
media sites is not included in the company's SEC
filings.(PGNX-F)
Contact: |
|
Melissa Downs |
|
|
Investor Relations |
|
|
(646)
975-2533 |
|
|
mdowns@progenics.com |
Progenics Pharmaceuticals (NASDAQ:PGNX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Progenics Pharmaceuticals (NASDAQ:PGNX)
Historical Stock Chart
From Apr 2023 to Apr 2024