Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced
financial results for the fourth quarter and full-year 2019.
“The recent positive top line results from the
Phase 3 CONDOR trial of PyL™ highlights the potential of our
radiopharmaceutical pipeline. By merging with Lantheus, we believe
we can leverage Lantheus’ long-standing expertise in complex
manufacturing, supply chain and commercial excellence to deliver on
the promise of PyL, AZEDRA® and our complementary PSMA-targeted
product portfolio,” said David Mims, Interim Chief Executive
Officer of Progenics.
Mr. Mims continued, “The reconstituted Progenics
Board’s support for the Lantheus merger is based on the culmination
of our thorough evaluation of the business prospects and operations
of Progenics as a stand-alone business, as well as the value of the
interest of Progenics’ shareholders in the combined company under
the revised terms. The Board believes the combination with Lantheus
under the newly revised negotiated terms of the merger agreement
represents the best pathway forward to maximize long-term
stockholder value.”
Fourth Quarter and Full-Year 2019
Financial Results
Fourth quarter 2019 revenue totaled $15.1
million, up from $3.2 million in the fourth quarter of 2018.
Full-year 2019 revenue totaled $35.0 million, up from $15.6 million
for the full-year 2018. The increases for the full year relate
primarily to a $10.0 million RELISTOR® sales milestone for the
achievement of U.S. net sales over $100 million, a $4.0 million
upfront payment from FUJIFILM under the aBSI agreement, a $2.0
milestone under the Bayer agreement for initiation of a Phase 1
trial of PSMA TTC, an increase of $2.1 million in RELISTOR
royalties and $1.6 million of AZEDRA net sales.
Research and development expenses increased by
$2.7 million and $14.1 million in the fourth quarter and full-year
2019, respectively, compared to the corresponding periods in 2018,
resulting primarily from higher costs associated with the
transition of the AZEDRA manufacturing site, initiatives to
increase production capacity and provide redundancy for
iodine-based products AZEDRA and 1095, and higher costs associated
with the clinical trials for 1095 and PyL. Fourth quarter and
full-year selling, general and administrative expenses increased by
$4.5 million and $18.4 million, respectively, compared to the
corresponding periods in 2018, primarily attributable to legal and
advisory fees associated with the contested election at our 2019
annual meeting of shareholders and the consent solicitation
campaign, legal and advisory fees associated with the merger
agreement with Lantheus in 2019, and higher PSMA-617 litigation
costs.
For the three months and full-year ended
December 31, 2019, Progenics recognized interest expense of $1.0
million and $4.1 million, respectively, related to the RELISTOR
royalty-backed loan, compared to $1.1 million and $4.7 million
recognized in the corresponding periods in 2018.
Net loss attributable to Progenics for the
fourth quarter was $11.3 million or $0.13 per diluted share,
compared to a net loss of $14.7 million or $0.17 per diluted share
in the corresponding 2018 period. Net loss for the full-year 2019
was $68.6 million or $0.80 per diluted share, compared to net loss
of $67.7 million or $0.87 per diluted share for the full-year
2018.
Progenics ended the year with cash and cash
equivalents of $42.0 million, reflecting a decrease of $22.5
million in the quarter and a decrease of $95.7 million from 2018
year-end, reflecting primarily cash used for operating expenses and
for the acquisition of the Somerset manufacturing site for AZEDRA,
as well as for capital expenditures to increase production capacity
and provide redundancy for iodine-based products.
Due to the pending merger with Lantheus,
Progenics will not be hosting a conference call this quarter.
- Financial Tables follow –
PROGENICS PHARMACEUTICALS,
INC.CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except per share data) |
|
|
For the Three Months EndedDecember
31, |
|
|
For the Year EndedDecember
31, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
(Unaudited) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
$ |
719 |
|
$ |
- |
|
$ |
1,559 |
|
$ |
- |
|
Royalty income |
|
4,304 |
|
|
3,151 |
|
|
16,970 |
|
|
14,908 |
|
License and other revenues |
|
10,103 |
|
|
87 |
|
|
16,457 |
|
|
714 |
|
Total revenues |
|
15,126 |
|
|
3,238 |
|
|
34,986 |
|
|
15,622 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
1,358 |
|
|
- |
|
|
3,168 |
|
|
- |
|
Research and development |
|
12,312 |
|
|
9,600 |
|
|
49,223 |
|
|
35,147 |
|
Selling, general and administrative |
|
12,571 |
|
|
8,090 |
|
|
47,838 |
|
|
29,431 |
|
Intangible impairment charge |
|
- |
|
|
- |
|
|
- |
|
|
23,200 |
|
Change in contingent consideration liability |
|
(400 |
) |
|
(100 |
) |
|
916 |
|
|
(5,800 |
) |
Total operating expenses |
|
25,841 |
|
|
17,790 |
|
|
101,145 |
|
|
81,978 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(10,715 |
) |
|
(14,552 |
) |
|
(66,159 |
|
|
(66,356 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense) income, net |
|
(543 |
) |
|
(235 |
) |
|
(2,376 |
) |
|
(2,933 |
) |
Total other (expense) income |
|
(543 |
|
|
(235 |
) |
|
(2,376 |
) |
|
(2,933 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax
benefit |
|
(11,258 |
) |
|
(14,787 |
) |
|
(68,535 |
) |
|
(69,289 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit (expense) |
|
(17 |
) |
|
83 |
|
|
(17 |
|
|
1,632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(11,275 |
) |
$ |
(14,704 |
) |
$ |
(68,552 |
) |
$ |
(67,657 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
(0.13 |
) |
$ |
(0.17 |
) |
$ |
(0.80 |
) |
$ |
(0.87 |
) |
Weighted average shares
outstanding – basic and diluted |
|
86,434 |
|
|
84,543 |
|
|
85,607 |
|
|
77,890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS(In
thousands) |
|
|
December 31, 2019 |
|
December 31, 2018 |
|
|
|
|
|
Cash and cash equivalents |
$ |
42,049 |
$ |
137,686 |
Accounts receivable, net |
|
15,976 |
|
3,803 |
Property and equipment, net |
|
11,688 |
|
3,944 |
Intangible assets, net and
goodwill |
|
24,670 |
|
19,740 |
Other assets |
|
25,087 |
|
4,324 |
Total assets |
$ |
119,470 |
$ |
169,497 |
|
|
|
|
|
Current liabilities |
$ |
22,068 |
$ |
23,446 |
Contingent consideration
liability |
|
3,900 |
|
3,950 |
Long-term debt, deferred tax and
other liabilities |
|
46,949 |
|
41,026 |
Total liabilities |
|
72,917 |
|
68,422 |
Total stockholders’ equity |
|
46,553 |
|
101,075 |
Total liabilities and stockholders’ equity |
$ |
119,470 |
$ |
169,497 |
Indication AZEDRA® (iobenguane I 131) is
indicated for the treatment of adult and pediatric patients 12
years and older with iobenguane scan positive, unresectable,
locally advanced or metastatic pheochromocytoma or paraganglioma
who require systemic anticancer therapy.
Important Safety Information Warnings
and Precautions: Risk from radiation
exposure: AZEDRA contributes to a patient’s overall
long-term radiation exposure. Long-term cumulative radiation
exposure is associated with an increased risk for cancer. These
risks of radiation associated with the use of AZEDRA are greater in
pediatric patients than in adults. Minimize radiation exposure to
patients, medical personnel, and household contacts during and
after treatment with AZEDRA consistent with institutional good
radiation safety practices and patient management procedures.
Myelosuppression: Severe and prolonged
myelosuppression occurred during treatment with AZEDRA. Among the
88 patients who received a therapeutic dose of AZEDRA, 33%
experienced Grade 4 thrombocytopenia, 16% experienced Grade 4
neutropenia, and 7% experienced Grade 4 anemia. Five percent of
patients experienced febrile neutropenia. Monitor blood cell counts
weekly for up to 12 weeks or until levels return to baseline or the
normal range. Withhold and dose reduce AZEDRA as recommended in the
prescribing information based on severity of the cytopenia.
Secondary myelodysplastic syndrome, leukemia, and other
malignancies: Myelodysplastic syndrome (MDS) and
acute leukemias were reported in 6.8% of the 88 patients who
received a therapeutic dose of AZEDRA. The time to development of
MDS or acute leukemia ranged from 12 months to 7 years. Two of the
88 patients developed a non-hematological malignancy.
Hypothyroidism: Hypothyroidism was reported
in 3.4% of the 88 patients who received a therapeutic dose of
AZEDRA. Initiate thyroid-blocking medications starting at least 1
day before and continuing for 10 days after each AZEDRA dose to
reduce the risk of hypothyroidism or thyroid neoplasia. Evaluate
for clinical evidence of hypothyroidism and measure
thyroid-stimulating hormone (TSH) levels prior to initiating AZEDRA
and annually thereafter. Elevations in blood
pressure: Eleven percent of the 88 patients who
received a therapeutic dose of AZEDRA experienced a worsening of
pre-existing hypertension defined as an increase in systolic blood
pressure to ≥160 mmHg with an increase of 20 mmHg or an increase in
diastolic blood pressure to ≥100 mmHg with an increase of 10 mmHg.
All changes in blood pressure occurred within the first 24 hours
post infusion. Monitor blood pressure frequently during the first
24 hours after each therapeutic dose of AZEDRA. Renal
toxicity: Of the 88 patients who received a
therapeutic dose of AZEDRA, 7% developed renal failure or acute
kidney injury and 22% demonstrated a clinically significant
decrease in glomerular filtration rate (GFR) measured at 6 or 12
months. Monitor renal function during and after treatment with
AZEDRA. Patients with baseline renal impairment may be at greater
risk of toxicity; perform more frequent assessments of renal
function in patients with mild or moderate impairment. AZEDRA has
not been studied in patients with severe renal impairment.
Pneumonitis: Fatal pneumonitis occurred 9
weeks after a single dose in one patient in the expanded access
program. Monitor patients for signs and symptoms of pneumonitis and
treat appropriately. Embryo-fetal
toxicity: Based on its mechanism of action, AZEDRA
can cause fetal harm. Verify pregnancy status in females of
reproductive potential prior to initiating AZEDRA. Advise females
and males of reproductive potential of the potential risk to a
fetus and to use effective contraception during treatment with
AZEDRA and for 7 months after the final dose. Advise males with
female partners of reproductive potential to use effective
contraception during treatment and for 4 months after the final
dose. Risk of infertility: Radiation exposure
associated with AZEDRA may cause infertility in males and females.
Radiation absorbed by testes and ovaries from the recommended
cumulative dose of AZEDRA is within the range where temporary or
permanent infertility can be expected following external beam
radiotherapy.
Adverse Reactions: The most common severe
(Grade 3–4) adverse reactions observed in AZEDRA clinical trials
(≥10%) were lymphopenia (78%), neutropenia (59%), thrombocytopenia
(50%), fatigue (26%), anemia (24%), increased international
normalized ratio (18%), nausea (16%), dizziness (13%), hypertension
(11%), and vomiting (10%). Twelve percent of patients discontinued
treatment due to adverse reactions (thrombocytopenia, anemia,
lymphopenia, nausea and vomiting, multiple hematologic adverse
reactions). Drug Interactions: Based on the
mechanism of action of iobenguane, drugs that reduce catecholamine
uptake or that deplete catecholamine stores may interfere with
iobenguane uptake into cells and therefore interfere with dosimetry
calculations or the efficacy of AZEDRA. These drugs were not
permitted in clinical trials that assessed the safety and efficacy
of AZEDRA. Discontinue the drugs listed in the prescribing
information for at least 5 half-lives before administration of
either the dosimetry dose or a therapeutic dose of AZEDRA. Do not
administer these drugs until at least 7 days after each AZEDRA
dose. For important risk and use information about AZEDRA,
please see Full Prescribing Information. To report
suspected adverse reactions, contact Progenics Pharmaceuticals,
Inc. at 844-668-3950 or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
Reference: AZEDRA® prescribing
information. New York, NY: Progenics Pharmaceuticals, Inc.; 08
2018.
About RELISTOR®
Progenics has exclusively licensed development and
commercialization rights for its first commercial product,
RELISTOR, to Bausch Health Companies, Inc. 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.bauschhealth.com. For more information about RELISTOR,
please visit www.RELISTOR.com.
About PROGENICS Progenics is an oncology
company focused on the development and commercialization of
innovative targeted medicines and artificial intelligence to find,
fight and follow cancer, including: therapeutic agents designed to
treat cancer (AZEDRA®, 1095, and PSMA TTC); prostate-specific
membrane antigen (“PSMA”) targeted imaging agents for prostate
cancer (PyL™ and 1404); and imaging analysis technology (aBSI and
PSMA AI). Progenics has three commercial products, AZEDRA, for the
treatment of patients with unresectable, locally advanced or
metastatic pheochromocytoma or paraganglioma (rare neuroendocrine
tumors of neural crest origin) who require systemic anticancer
therapy; and oral and subcutaneous formulations of
RELISTOR® (methylnaltrexone bromide) for the treatment of
opioid-induced constipation, which are partnered with Bausch Health
Companies Inc.
Important Information For Investors And
StockholdersThis document does not constitute an offer to
sell or the solicitation of an offer to buy any securities or a
solicitation of any vote or approval in any jurisdiction in which
such offer, solicitation or sale would be unlawful prior to
appropriate registration or qualification under the securities laws
of such jurisdiction. No offering of securities shall be made
except by means of a prospectus meeting the requirements of Section
10 of the U.S. Securities Act of 1933, as amended.
In connection with the proposed transaction, Lantheus Holdings
filed with the Securities and Exchange Commission (“SEC”) a
registration statement on Form S-4 on November 12, 2019
that includes a joint proxy statement of Lantheus Holdings and
Progenics that also constitutes a preliminary prospectus of
Lantheus Holdings. The registration statement has not yet become
effective. After the registration statement is declared effective
by the SEC, a definitive joint proxy statement/prospectus will be
mailed to stockholders of Lantheus Holdings and Progenics.
INVESTORS AND SECURITY HOLDERS OF LANTHEUS HOLDINGS AND PROGENICS
ARE STRONGLY ENCOURAGED TO READ THE JOINT PROXY
STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT ARE FILED OR WILL BE
FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY
CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION. Investors and
security holders are able to obtain free copies of the registration
statement and the joint proxy statement/prospectus and other
documents filed with the SEC by Lantheus Holdings or Progenics
through the website maintained by the SEC at
https://www.sec.gov.
Copies of the documents filed with the SEC by Lantheus Holdings
are or will also be available free of charge on Lantheus Holdings’
website at https://www.lantheus.com/ or by contacting Lantheus
Holdings’ Investor Relations Department by email at ir@lantheus.com
or by phone at (978) 671-8001. Copies of the documents
filed with the SEC by Progenics are or will also be available free
of charge on Progenics’ internet website at
https://www.progenics.com/ or by contacting Progenics’ Investor
Relations Department by email at mdowns@progenics.com or by phone
at (646) 975-2533.
Certain Information Regarding
ParticipantsLantheus Holdings, Progenics, and their
respective directors and executive officers may be considered
participants in the solicitation of proxies in connection with the
proposed transaction. Information about the directors and executive
officers of Lantheus Holdings is set forth in its Annual Report on
Form 10-K for the year ended December 31, 2019, which was
filed with the SEC on February 25, 2020, its definitive proxy
statement for its 2019 annual meeting of stockholders, which was
filed with the SEC on March 15, 2019, and its Current Report on
Form 8-K, which was filed with the SEC on March 25, 2019.
Other information regarding the participants of Lantheus Holdings
in the proxy solicitation and a description of their direct and
indirect interests, by security holdings or otherwise, will be
contained in the joint proxy statement/prospectus and other
relevant materials to be filed with the SEC regarding the proposed
transaction when they become available.
Information about the directors and executive officers of
Progenics is set forth in its Annual Report on
Form 10-K for the year ended December 31, 2018, which was
filed with the SEC on March 15, 2019 and amended on April 30, 2019,
its definitive proxy statement for its 2019 annual meeting of
stockholders, which was filed with the SEC on May 30, 2019, and its
Current Report on Form 8-K, which was filed with the SEC
on November 21, 2019. Other information regarding the participants
of Progenics in the proxy solicitations and a description of their
direct and indirect interests, by security holdings or otherwise,
will be contained in the joint proxy statement/prospectus and other
relevant materials to be filed with the SEC regarding the proposed
transaction when they become available. You may obtain these
documents (when they become available) free of charge through the
website maintained by the SEC at https://www.sec.gov and from
Investor Relations at Lantheus Holdings or Progenics as described
above.
Forward Looking Statements This press release
contains 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 and include
statements regarding Progenics’ strategic and operational plans and
delivering value for shareholders. 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: risks associated
with the proposed merger transaction with Lantheus Holdings, Inc.;
market acceptance for approved products; the risk that the
commercial launch of AZEDRA may not meet revenue and income
expectations; the cost, timing and unpredictability of results of
clinical trials and other development activities and
collaborations; the unpredictability of the duration and results of
regulatory review of New Drug Applications (“NDA”) and
Investigational NDAs; the inherent uncertainty of outcomes in
intellectual property disputes such as the dispute with University
of Heidelberg regarding PSMA-617; our ability to successfully
develop and commercialize products that incorporate licensed
intellectual property; 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; and 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 Securities and Exchange Commission (the “SEC”),
including those risk factors included in its Annual Report on Form
10-K for the year ended December 31, 2019. 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 press release. For
more information, please visit www.progenics.com. 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
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