Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced
financial results and provided a business update for the fourth
quarter and full-year 2016.
“Since the beginning of 2016, we have made
tremendous progress in advancing our robust pipeline of innovative
cancer treatments and executing against our strategic corporate
goals,” said Mark Baker, CEO of Progenics. “2017 has the potential
to be a transformational year for Progenics, with AZEDRA topline
data from our registrational trial in pheochromocytoma and
paraganglioma expected in the coming weeks. Should we report
positive data and meet the requirements of the Special Protocol
Assessment, we will move quickly toward an NDA as we strive to
introduce a promising treatment to patients with these rare and
difficult-to-treat cancers.”
Mr. Baker continued, “We also continued to
advance our novel portfolio of prostate cancer imaging agents and
therapeutics in 2016, including 1404, PyL and 1095, which could
transform how physicians and patients find, fight and followTM
prostate cancer. We are encouraged by the significant investigator
interest in our PSMA-targeted candidates, and with our strong cash
position, we look forward to progressing these programs through key
trials this year.”
Fourth Quarter and Recent Key Business
Highlights
AZEDRA, Ultra-orphan radiotherapeutic candidate
- AZEDRA Topline Results Expected First Quarter
2017. Progenics expects to report topline results from its
ongoing registrational trial of AZEDRA by the end of March 2017.
With positive data (AZEDRA trial meets the primary endpoint of the
Special Protocol Assessment (SPA)), the Company expects to submit a
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) in mid-2017.
PSMA-Targeted Prostate Cancer Pipeline
- Positive DMC Recommendation for Continuation of Phase 3
Study of 1404. In December 2016, an independent Data
Monitoring Committee (DMC) completed its review of an interim
analysis of the Company’s ongoing Phase 3 clinical trial of its
PSMA-targeted SPECT/CT imaging agent candidate 1404, and
recommended that the trial continue. The study is designed to
evaluate the specificity of 1404 imaging to identify patients
without clinically significant prostate cancer and sensitivity to
identify patients with clinically significant disease.
- Initiated Phase 2/3 Trial of PSMA-Targeted PET/CT
Imaging Agent PyL™. Also in December 2016, Progenics
announced that the first patient had been dosed in a Phase 2/3
trial of PyL. The study is designed to evaluate the diagnostic
accuracy of PyL PET/CT imaging in patients with metastatic prostate
cancer.
- Launched PyL Research Access ProgramTM. In
November 2016, Progenics announced a research access program making
limited doses of PyL available to researchers. Progenics plans to
use data generated from the access program to support its
registration efforts for PyL and advance the development of
algorithms designed to analyze and interpret the scans.
- Initiated Phase 1 Trial of 1095 for the Treatment of
Metastatic Prostate Cancer. The trial, which is being
conducted at Memorial Sloan Kettering Cancer Center, is expected to
include approximately 30 patients with mCRPC who have demonstrated
tumor avidity to 1095. The objectives of this trial are to
determine the maximum tolerated dose, safety and tolerability,
biodistribution, and efficacy — results that will guide the
decision of an optimal dose for a potential Phase 2 study.
RELISTOR, treatment for OIC (partnered with
Valeant Pharmaceuticals International,
Inc.)
- RELISTOR (SC and Oral) Net Sales for the Fourth Quarter
of 2016 Totaled $16 million. Full-year 2016 net sales
totaled $70.6 million as reported by our partner,
Valeant.
- Announced $50 Million RELISTOR Royalty-Backed
Non-Dilutive Debt Financing with HealthCare Royalty
Partners. In November 2016, Progenics announced a $50
million non-recourse, term loan agreement at a per annum interest
rate of 9.50 percent, to be secured by and repaid from royalties on
future sales of RELISTOR. Any future sales milestones received
under Valeant agreement are excluded from the transaction and would
not be used to repay interest or principal on the loan.
Fourth Quarter and Full-Year 2016
Financial Results
Total revenue decreased $0.4 million for the
fourth quarter and increased $60.8 million for the full-year, over
the fourth quarter and full-year of 2015, respectively. The
full-year increase was due primarily to milestone revenue of $50
million for the July 19 FDA approval of RELISTOR Tablets, higher
RELISTOR royalty income, and the recognition of $7 million in
upfront and development milestone payments from Bayer for the
collaboration of our PSMA antibody technology in combination with
Bayer’s alpha-emitting radionuclides.
Fourth quarter and full-year research and
development expenses increased by $2.7 million and $9.4 million,
respectively, compared to the corresponding periods in 2015,
resulting primarily from higher clinical trial expenses for 1404
and PyL and higher contract manufacturing expenses for 1095, PyL
and AZEDRA. Fourth quarter and full-year general and administrative
expenses increased by $1 million and $5.2 million, respectively,
compared to the corresponding prior year periods, primarily
attributable to higher depreciation expense as a result of a
reduction in the remaining useful lives of our leasehold
improvements at our Tarrytown, NY former location and higher
compensation and market research expenses. Progenics also recorded
non-cash adjustments of $6 million and $4.6 million in the fourth
quarter and full-year 2016, respectively, related to a decrease in
the fair value estimate of the contingent consideration
liability.
Net loss attributable to Progenics for the
quarter was $7.2 million or $0.10 per diluted share, compared to a
net loss of $7.1 million or $0.10 per diluted share in the
corresponding 2015 period. Net income attributable to Progenics for
the full-year 2016 was $10.8 million or $0.15 per basic and diluted
share, compared to net loss of $39.1 million or $0.56 per diluted
share for the full-year 2015.
Progenics ended the year with cash and cash
equivalents of $138.9 million, reflecting increases of $40 million
in the quarter and $64.8 million from 2015 year-end.
Conference Call and Webcast
Progenics will review fourth quarter and
year-end financial results in a conference call today at 8:30 a.m.
EST. To participate, please dial (877) 250-8889 (domestic) or (720)
545-0001 (international) and reference conference ID 75789158. 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.
PROGENICS PHARMACEUTICALS,
INC.CONSOLIDATED STATEMENTS OF
OPERATIONS (In thousands, except per share data) |
|
|
For the Three Months
EndedDecember 31, |
|
|
For the Year EndedDecember
31, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Royalty income |
$ |
2,407 |
|
$ |
3,453 |
|
$ |
10,295 |
|
$ |
6,608 |
|
License revenue |
|
2,242 |
|
|
1,562 |
|
|
59,081 |
|
|
1,955 |
|
Other revenues |
|
3 |
|
|
80 |
|
|
53 |
|
|
113 |
|
Total revenues |
|
4,652 |
|
|
5,095 |
|
|
69,429 |
|
|
8,676 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
10,605 |
|
|
7,941 |
|
|
37,569 |
|
|
28,196 |
|
General and
administrative |
|
4,719 |
|
|
3,760 |
|
|
23,356 |
|
|
18,184 |
|
Change in contingent
consideration liability |
|
(6,000 |
) |
|
700 |
|
|
(4,600 |
) |
|
1,600 |
|
Total operating
expenses |
|
9,324 |
|
|
12,401 |
|
|
56,325 |
|
|
47,980 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
(loss) |
|
(4,672 |
) |
|
(7,306 |
) |
|
13,104 |
|
|
(39,304 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense)
income, net |
|
(669 |
) |
|
19 |
|
|
(493 |
) |
|
52 |
|
Other expense, net |
|
(34 |
) |
|
- |
|
|
(34 |
) |
|
- |
|
Total other (expense)
income |
|
(703 |
) |
|
19 |
|
|
(527 |
) |
|
52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before
income tax (expense) benefit |
|
(5,375 |
) |
|
(7,287 |
) |
|
12,577 |
|
|
(39,252 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax (expense)
benefit |
|
(1,844 |
) |
|
133 |
|
|
(1,844 |
) |
|
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
(7,219 |
) |
|
(7,154 |
) |
|
10,733 |
|
|
(39,119 |
) |
Net loss attributable
to noncontrolling interests |
|
(15 |
) |
|
(7 |
) |
|
(73 |
) |
|
(7 |
) |
Net income
(loss) attributable to Progenics |
$ |
(7,204 |
) |
$ |
(7,147 |
) |
$ |
10,806 |
|
$ |
(39,112 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share attributable to Progenics - basic |
$ |
(0.10 |
) |
$ |
(0.10 |
) |
$ |
0.15 |
|
$ |
(0.56 |
) |
Weighted
average shares outstanding - basic |
|
70,102 |
|
|
69,874 |
|
|
70,003 |
|
|
69,716 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share attributable to Progenics - diluted |
$ |
(0.10 |
) |
$ |
(0.10 |
) |
$ |
0.15 |
|
$ |
(0.56 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding - diluted |
|
70,102 |
|
|
69,874 |
|
|
70,155 |
|
|
69,716 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands) |
|
|
December 31, 2016 |
|
December 31, 2015 |
|
|
|
|
|
Cash and cash
equivalents |
$ |
138,909 |
$ |
74,103 |
Accounts receivable,
net |
|
4,864 |
|
3,543 |
Property and equipment,
net |
|
4,760 |
|
2,407 |
Intangible assets, net
and goodwill |
|
43,655 |
|
43,867 |
Other assets |
|
6,798 |
|
7,331 |
Total assets |
$ |
198,986 |
$ |
131,251 |
|
|
|
|
|
Current
liabilities |
$ |
16,357 |
$ |
9,729 |
Acquisition-related
contingent consideration liability |
|
14,200 |
|
18,800 |
Long-term debt,
deferred tax and other liabilities |
|
63,667 |
|
12,061 |
Total
liabilities |
|
94,224 |
|
40,590 |
Total
Progenics stockholders’ equity |
|
104,762 |
|
90,456 |
Noncontrolling interests |
|
- |
|
205 |
Total stockholders’ equity |
|
104,762 |
|
90,661 |
Total liabilities and stockholders’ equity |
$ |
198,986 |
$ |
131,251 |
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 in patients with
chronic non-cancer pain. RELISTOR Subcutaneous Injection (12
mg and 8 mg) is a treatment for opioid-induced constipation (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 opioid-induced constipation 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 Pharmaceuticals, Inc. develops
innovative medicines and other technologies to target and treat
cancer. The Company’s pipeline includes: 1) therapeutic agents
designed to precisely target cancer (AZEDRA® and 1095), 2)
PSMA-targeted imaging agents for prostate cancer (1404 and PyLTM),
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 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
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