Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced
financial results and provided a business update for the first
quarter of 2017.
“This first quarter of 2017 was marked by major
developments within our clinical pipeline, particularly the
announcement of positive topline data from our registrational Phase
2b study of AZEDRA for the treatment of pheochromocytoma and
paraganglioma,” said Mark Baker, Chief Executive Officer of
Progenics. “The study not only achieved its primary endpoint by a
significant margin, but also showed that treatment with AZEDRA
resulted in favorable anti-tumor activity, a key secondary
endpoint. We are now working diligently to complete our New Drug
Application for this important new therapy, which we remain on
track to submit by the middle of this year.”
Mr. Baker continued, “With our portfolio of
PSMA-targeted therapeutics and imaging agents, we continue to
leverage our Find Fight and Follow™ strategy that provides us with
multiple opportunities to improve the lives of patients who have or
are at risk of developing prostate cancer. During the quarter, we
continued to advance clinical trials of our three prostate cancer
theranostic candidates, 1404, PyL, and 1095, reported positive data
regarding our Automated Bone Scan Index (aBSI), and look forward to
providing further updates on our progress throughout the year.”
First Quarter and Recent Key Business
Highlights
AZEDRA, Ultra-orphan radiotherapeutic candidate
- Positive Topline Results for AZEDRA Announced in the
First Quarter 2017. In March 2017, Progenics reported
positive topline data from its Phase 2b registrational trial of
AZEDRA for the treatment of rare and difficult-to-treat
neuroendocrine tumors, pheochromocytoma and paraganglioma. The
primary endpoint evaluated a proportion of patients who achieved a
50% or greater reduction in all antihypertensive medication for at
least six months. Under the study protocol agreed to with the U.S.
Food and Drug Administration (FDA), the primary endpoint was to be
achieved if the lower limit of the two-sided 95% confidence
interval was above 10%. In order to achieve this primary endpoint,
a minimum of 12 of the total 68 evaluable patients must have a 50%
or greater reduction of all antihypertensive medication for at
least 6 months. The trial met the primary endpoint with 17 of the
68 evaluable patients experiencing at least a 50% reduction in all
antihypertensive medication for at least six months, with a 95%
confidence interval lower limit of 16.15%. 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. Of the 64
RECIST evaluable patients, 92.2% of patients showed a best response
of partial response or stable disease.AZEDRA was generally well
tolerated. The most common treatment emergent adverse events were
nausea, thrombocytopenia, anemia, fatigue, leukopenia, and
neutropenia. These events are consistent with those observed
in prior AZEDRA studies.Based on these data, the Company has
already submitted non-clinical sections of the New Drug Application
to the FDA and expects to complete the submission by mid-2017.
PSMA-Targeted Prostate Cancer Pipeline
- Data Presentations Highlighting Utility of Automated
Bone Scan Index (aBSI). In February 2017, data was
presented at the American Society of Clinical Oncology
Genitourinary (ASCO GU) Meeting demonstrating the utility of
Progenics’ aBSI to quantitatively assess total tumor burden during
the course of disease progression as called for by the Prostate
Cancer Working Group (PCWG). The data will also be presented at the
upcoming ASCO 2017 meeting. Also at ASCO, a prognostic analysis of
aBSI in men with metastatic castration-resistant prostate cancer
(mCRPC) using data from a Phase 3 trial of a prostate cancer
therapeutic will be discussed in an oral presentation.
- Phase 3 Study of 1404 Remains On-Track; Phase 2 Data
Published in the Journal of Nuclear Medicine. Progenics
continues to enroll patients in a Phase 3 study of 1404. The trial
is designed to evaluate the specificity of the imaging agent in
identifying patients without clinically significant prostate cancer
as well as its sensitivity to identify patients with clinically
significant disease, and will include approximately 450 patients.
Progenics still expects to complete enrollment by the end of 2017.
In March 2017, data from
a Phase 2 study of 1404 were published in the online edition of the
Journal of Nuclear Medicine. The data reviewed previously reported
results demonstrating the sensitivity of 1404 to detect prostate
cancer, potentially enabling better assessment of the stage and
extent of a patient’s prostate cancer versus biopsy.
- Advancing Phase 2/3 Study of PyL™. Progenics’
study evaluating the diagnostic accuracy of PyL PET/CT imaging in
patients with metastatic prostate cancer continues to enroll
patients. The Phase 2/3 study will enroll approximately 300
patients with recurrent and/or metastatic prostate cancer in the
United States and Canada.
- Initiated Phase 1 Trial of 1095. Dosing has
commenced in the Phase 1 open-label dose escalation study of 1095.
The study, which is being conducted at Memorial Sloan Kettering, is
expected to enroll approximately 30 patients with mCRPC who have
demonstrated tumor avidity to 1095. The study’s primary objectives
are to determine the maximum tolerated dose, safety and
tolerability, biodistribution, and efficacy.
RELISTOR, treatment for opioid-induced
constipation (partnered with Valeant Pharmaceuticals International,
Inc.)
- First Quarter 2017 RELISTOR® Net Sales of $14.1
Million. The first quarter 2017 sales, as reported to
Progenics by its partner Valeant, translated to $2.1 million in
royalty revenue for Progenics for the quarter.
First Quarter 2017 Financial Results
First quarter revenue totaled $2.3 million, down
from $2.5 million in the first quarter of 2016, reflecting RELISTOR
royalty income of $2.1 million compared to $2.2 million in the
corresponding period of 2016.
First quarter research and development expenses
increased by $0.9 million compared to the corresponding prior year
period, resulting primarily from higher clinical trial and contract
manufacturing expenses for PyL, partially offset by lower
compensation expenses. First quarter general and administrative
expenses decreased by $0.1 million compared to the corresponding
prior year period, primarily attributable to lower depreciation and
compensation expenses, partially offset by higher costs associated
with pre-launch activities for AZEDRA. Progenics also recorded a
non-cash charge of $1.9 million in the first quarter related to an
increase in the fair value estimate of the contingent consideration
liability primarily resulting from an increase in the probability
of success of AZEDRA used to calculate the potential milestone
payments to former Molecular Insight Pharmaceuticals, Inc.
stockholders. For the three months ended March 31, 2017, Progenics
recognized interest expense, including amortization of the debt
discount, related to the RELISTOR royalty-backed loan, of $1.3
million.
Net loss attributable to Progenics for the
quarter was $16.4 million or $0.23 per diluted share, compared to a
net loss of $12.7 million or $0.18 per diluted share in the
corresponding 2016 period. Progenics ended the quarter with cash
and cash equivalents of $126.3 million, a decrease of $12.6 million
compared to cash and cash equivalents as of December 31, 2016.
Conference Call and Webcast
Progenics will review first 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 13716707. 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
EndedMarch 31, |
|
|
2017 |
|
|
2016 |
Revenues: |
|
(unaudited) |
Royalty income |
$ |
2,119 |
|
|
$ |
2,189 |
|
License revenue |
|
215 |
|
|
|
242 |
|
Other revenues |
|
13 |
|
|
|
19 |
|
Total revenues |
|
2,347 |
|
|
|
2,450 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
|
10,005 |
|
|
|
9,149 |
|
General and
administrative |
|
5,695 |
|
|
|
5,817 |
|
Change in contingent
consideration liability |
|
1,900 |
|
|
|
200 |
|
Total operating
expenses |
|
17,600 |
|
|
|
15,166 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(15,253 |
) |
|
|
(12,716 |
) |
|
|
|
|
|
|
|
|
Other (expense)
income: |
|
|
|
|
|
|
|
Interest (expense)
income, net |
|
(1,107 |
) |
|
|
43 |
|
Total other (expense)
income |
|
(1,107 |
) |
|
|
43 |
|
|
|
|
|
|
|
|
|
Net loss |
|
(16,360 |
) |
|
|
(12,673 |
) |
Net loss attributable
to noncontrolling interests |
|
- |
|
|
|
(18 |
) |
Net loss
attributable to Progenics |
$ |
(16,360 |
) |
|
$ |
(12,655 |
) |
|
|
|
|
|
|
|
|
Net loss per
share attributable to Progenics – basic and diluted |
$ |
(0.23 |
) |
|
$ |
(0.18 |
) |
Weighted
average shares outstanding – basic and diluted |
|
70,196 |
|
|
|
69,946 |
|
|
|
CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands) |
|
|
March 31, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
|
(unaudited) |
|
(audited) |
Cash and cash
equivalents |
$ |
126,306 |
$ |
138,909 |
Accounts receivable,
net |
|
2,097 |
|
4,864 |
Property and equipment,
net |
|
4,702 |
|
4,760 |
Intangible assets, net
and goodwill |
|
43,602 |
|
43,655 |
Other assets |
|
6,147 |
|
6,798 |
Total assets |
$ |
182,854 |
$ |
198,986 |
|
|
|
|
|
Current
liabilities |
$ |
14,353 |
$ |
16,357 |
Acquisition-related
contingent consideration liability |
|
16,100 |
|
14,200 |
Long-term debt,
deferred tax and other liabilities |
|
63,146 |
|
63,667 |
Total
liabilities |
|
93,599 |
|
94,224 |
Total
stockholders’ equity |
|
89,255 |
|
104,762 |
Total liabilities and stockholders’
equity |
$ |
182,854 |
$ |
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 about
RELISTOR
RELISTOR (methylnaltrexone bromide) Tablets 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 OIC 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. Take into account the overall risk-benefit
profile when using RELISTOR in such patients. Monitor for adequacy
of analgesia and symptoms of opioid withdrawal in such
patients.
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 most common adverse reactions (≥
12%) in adult patients with OIC and chronic non-cancer pain
receiving RELISTOR tablets were abdominal pain, diarrhea,
headaches, abdominal distention, hyperhidrosis, anxiety, muscle
spasms, rhinorrhea, and chills. Adverse reactions of abdominal
pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may
reflect symptoms of opioid withdrawal.
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 integrate
EXINI Diagnostics AB and to develop and commercialize its products;
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 Aug 2024 to Sep 2024
Progenics Pharmaceuticals (NASDAQ:PGNX)
Historical Stock Chart
From Sep 2023 to Sep 2024