Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced
financial results and provided a business update for the second
quarter of 2017.
“We are nearing completion of the NDA for AZEDRA
and expect to complete the rolling submission to the FDA this
month,” said Mark Baker, Chief Executive Officer of
Progenics. “The application is based on our Phase 2b data,
which suggest that AZEDRA could deliver meaningful benefits to
malignant and/or recurrent and/or unresectable pheochromocytoma and
paraganglioma patients, who do not currently have approved
therapies in the U.S. We announced topline data on March 30th and
look forward to presenting the results from this trial at the
International Symposium of Pheochromocytoma and Paraganglioma
meeting on September 1st. Our PSMA-targeted pipeline, including our
imaging agents 1404 and PyL and our therapeutic agent, 1095,
continues to progress with the strategic goal to Find Fight and
Follow™ – detect, treat and monitor – prostate cancer. I am
especially pleased to see the momentum building in Oral RELISTOR
prescriptions, which we believe underscores the long-term potential
for that franchise,” Mr. Baker added.
Second Quarter and Recent Key Business
Highlights
AZEDRA, Ultra-orphan radiotherapeutic
candidate
- AZEDRA NDA Expected to be Submitted August
2017Progenics expects to complete the rolling submission
of the NDA for AZEDRA in patients with malignant and/or recurrent
pheochromocytoma to the FDA in August 2017. The filing will be
supported by data from a pivotal Phase 2b trial, which met the
primary endpoint evaluating the proportion of patients who achieved
a 50% or greater reduction of all antihypertensive medications for
at least six months. In addition, favorable data was reported for a
key secondary endpoint, the proportion of patients with overall
tumor response as measured by Response Evaluation Criteria in Solid
Tumors (RECIST) criteria. AZEDRA was also shown to be safe and
generally well tolerated.AZEDRA holds Breakthrough Therapy and
Orphan Drug statuses, as well as a Fast Track designation in the
U.S. under a Special Protocol Assessment agreement with the
FDA.
- Additional Data from Phase 2b Trial of AZEDRA to be
Presented at ISP 2017In September 2017, Progenics will
present further results from its Phase 2b study evaluating AZEDRA,
for which topline data were announced in March 2017.
PSMA-Targeted Prostate Cancer Pipeline
- Data Demonstrating Potential Use of Automated Bone Scan
Index Presented at ASCO 2017 MeetingIn June 2017, two
presentations highlighting the utility of aBSI were presented at
the American Society of Clinical Oncology’s Annual Meeting.•
In an oral presentation, investigators demonstrated the
potential of aBSI to serve as quantitative prognostic biomarker for
survival in patients with bone-metastatic castration resistant
prostate cancer (CPRC). The large scale Phase 3 study
demonstrated that in these patients, aBSI at baseline was
prognostic for overall and disease specific survival (p
<0.0001), progression free survival (p =0.0024), radiographic
progression-free survival (rPFS) (p =0.0061), and symptomatic
skeletal related events (SSEs) (p =0.0068).• An additional
poster showed that aBSI could be used to quantitatively assess
total tumor burden during the course of disease progression, as
called for by Prostate Cancer Working Group criteria. The
data presented in the poster was also published in the Journal of
Nuclear Medicine, and the Progenics researcher, Dr. Aseem Anand,
was selected for the Alavi–Mandell Award for that
publication.
- Advancing Phase 3 Study of
1404 Enrollment in the Phase 3 study of 1404, a
PSMA-targeted imaging agent, is ongoing. The trial is designed to
evaluate the specificity of 1404 in identifying patients without
clinically significant prostate cancer, as well as its sensitivity
to identify patients with clinically significant disease.
- Advancing Phase 2/3 Study of PyLEnrollment is
also continuing in the Phase 2/3 study evaluating the diagnostic
accuracy of PyL PET/CT imaging in patients with recurrent and/or
metastatic prostate cancer. The trial is being conducted in the
U.S. and Canada.
- Advancing Phase 1 Trial of 1095Dosing and
enrollment are ongoing in the Phase 1 open-label dose escalation
study of 1095 in patients with metastatic CRPC who have
demonstrated tumor avidity to 1095. The study is being
conducted at Memorial Sloan Kettering.
RELISTOR, treatment for opioid-induced
constipation (partnered with Valeant Pharmaceuticals International,
Inc.)
- Second Quarter 2017 RELISTOR Net Sales of $17.3
MillionThe second 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 68% over the preceding quarter.
Second Quarter 2017 Financial
Results
Second quarter revenue totaled $2.8 million,
down from $8.5 million in the second quarter of 2016. RELISTOR
royalty income was $2.6 million during the second quarter compared
to $2.4 million in the corresponding period of 2016. The prior year
period included upfront and milestone revenue of $5.0 million under
the Bayer license agreement.
Second quarter research and development expenses
increased by $3.3 million compared to the corresponding prior year
period, resulting primarily from higher clinical trial expenses for
PyL and 1404, and costs associated with the preparation of the NDA
for AZEDRA. Second quarter general and administrative expenses
increased by $0.7 million compared to the corresponding prior year
period, primarily attributable to higher costs associated with
building our commercial capabilities in preparation of the AZEDRA
launch and higher stock-based compensation expense, partially
offset by lower depreciation expense. For the three months ended
June 30, 2017, Progenics recognized interest expense (including
amortization of the debt discount) of $1.1 million related to the
RELISTOR royalty-backed loan.
Net loss attributable to Progenics for the
quarter was $16.6 million or $0.24 per diluted share, compared to a
net loss of $5.6 million or $0.08 per diluted share in the
corresponding 2016 period. Progenics ended the quarter with cash
and cash equivalents of $114.0 million, a decrease of $24.9 million
compared to cash and cash equivalents as of December 31, 2016.
Conference Call and Webcast
Progenics will review second 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 59855960. 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 EndedJune
30, |
For the Six Months EndedJune
30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Revenues: |
|
|
|
|
(Unaudited) |
|
|
|
|
Royalty income |
$ |
2,601 |
|
$ |
2,380 |
|
$ |
4,720 |
|
$ |
4,569 |
|
License revenue |
|
147 |
|
|
6,073 |
|
|
362 |
|
|
6,315 |
|
Other revenues |
|
17 |
|
|
23 |
|
|
30 |
|
|
42 |
|
Total revenues |
|
2,765 |
|
|
8,476 |
|
|
5,112 |
|
|
10,926 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
11,292 |
|
|
7,988 |
|
|
21,297 |
|
|
17,137 |
|
General and
administrative |
|
6,333 |
|
|
5,599 |
|
|
12,028 |
|
|
11,416 |
|
Change in contingent
consideration liability |
|
700 |
|
|
600 |
|
|
2,600 |
|
|
800 |
|
Total operating
expenses |
|
18,325 |
|
|
14,187 |
|
|
35,925 |
|
|
29,353 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(15,560 |
) |
|
(5,711 |
) |
|
(30,813 |
) |
|
(18,427 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense)
income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense)
income, net |
|
(1,076 |
) |
|
54 |
|
|
(2,183 |
) |
|
97 |
|
Total other (expense)
income |
|
(1,076 |
) |
|
54 |
|
|
(2,183 |
) |
|
97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(16,636 |
) |
|
(5,657 |
) |
|
(32,996 |
) |
|
(18,330 |
) |
Net loss attributable
to noncontrolling interests |
|
- |
|
|
(19 |
) |
|
- |
|
|
(37 |
) |
Net loss
attributable to Progenics |
$ |
(16,636 |
) |
$ |
(5,638 |
) |
$ |
(32,996 |
) |
$ |
(18,293 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share attributable to Progenics - basic and diluted |
$ |
(0.24 |
) |
$ |
(0.08 |
) |
$ |
(0.47 |
) |
$ |
(0.26 |
) |
Weighted
average shares outstanding – basic and diluted |
|
70,202 |
|
|
69,947 |
|
|
70,214 |
|
|
69,947 |
|
|
CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands) |
|
|
June 30, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
|
(unaudited) |
|
(audited) |
Cash and cash
equivalents |
$ |
113,959 |
$ |
138,909 |
Accounts receivable,
net |
|
2,715 |
|
4,864 |
Property and equipment,
net |
|
4,563 |
|
4,760 |
Intangible assets, net
and goodwill |
|
43,549 |
|
43,655 |
Other assets |
|
5,741 |
|
6,798 |
Total assets |
$ |
170,527 |
$ |
198,986 |
|
|
|
|
|
Current
liabilities |
$ |
16,479 |
$ |
16,357 |
Acquisition-related
contingent consideration liability |
|
16,800 |
|
14,200 |
Long-term debt,
deferred tax and other liabilities |
|
62,698 |
|
63,667 |
Total
liabilities |
|
95,977 |
|
94,224 |
Total
stockholders’ equity |
|
74,550 |
|
104,762 |
Total liabilities and stockholders’
equity |
$ |
170,527 |
$ |
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 Progenics
Progenics 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
OIC, 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 and Investigational NDAs; 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; and general business, financial and
accounting matters, litigation and other risks. More information
concerning Progenics and such risks and uncertainties is available
on our website, and in our press releases and reports we file with
the U.S. Securities and Exchange Commission. Progenics is providing
the information in this press release only 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 Progenics’ 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