Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced
financial results for the first quarter 2020.
“Progenics’ Board of Directors continues to
believe the proposed merger with Lantheus under the revised terms
is the best pathway forward to maximize shareholder value and
escalate the advancement of its portfolio of radiopharmaceuticals
for the detection and treatment of cancer,” said David Mims,
Interim Chief Executive Officer of Progenics. “We are also
encouraged by the conviction that the Velan Group has shown in the
transaction and the combined company by entering into a support
agreement with Lantheus. While we collaborate with the
Lantheus team on integration planning in advance of a planned
transaction close in the second quarter of this year, Progenics
continues to advance its internal pipeline initiatives, including
the AZEDRA commercial launch, which recorded increased patient
usage during the quarter, regulatory filing preparations for PyL
and the clinical development of our PSMA-targeted programs.”
Mr. Mims continued, “Progenics remains focused
on executing on our corporate goals, even in these unprecedented
times driven by the emergence of the global COVID-19 pandemic. Our
team has proactively taken several measures to mitigate the impact
of COVID-19 on our business operations, preserve clinical trial
integrity and manage our capital resources. We will continue to
monitor the changing COVID-19 environment and make additional
adjustments as needed. Our top priority remains the safety of our
key community members, including patients, healthcare providers,
employees and industry partners.”
First Quarter and Recent Key Business
Highlights
Corporate Update
- Pending Merger with
Lantheus Holdings, Inc. (Lantheus) for Combination of an Innovative
Commercial Life Sciences Company with a Diversified Diagnostics and
Therapeutics Portfolio In February, Progenics announced
its entry into an amended and restated agreement and plan of merger
with Lantheus, which amends the previously announced agreement and
plan of merger dated as of October 1, 2019. Under the terms of the
amended agreement, Lantheus agreed to acquire all of the issued and
outstanding shares of Progenics common stock at a fixed exchange
ratio whereby Progenics stockholders will receive, for each share
of Progenics stock held at the time of the closing of the merger,
0.31 of a share of Lantheus common stock, an increase from 0.2502
under the original agreement, together with a non-transferable
contingent value right (CVR). The CVR is payable in two contingent
payments, subject to a cap, upon the achievement of certain
milestones subject to the terms of the Contingent Value Rights
Agreement to be entered into between Lantheus and a rights agent
reasonably acceptable to Progenics at or immediately prior to the
effective time of the merger. As a result of the increase in the
exchange ratio, following the completion of the merger, former
Progenics stockholders’ aggregate ownership stake will increase to
approximately 40% of the combined company from approximately 35%
under the terms set forth in the Original Agreement.The transaction
is expected to close in the second quarter of 2020, subject to
approval by Lantheus and Progenics stockholders, regulatory
approvals, and other customary closing conditions. Additional
details can be found in the joint proxy statement/prospectus to
stockholders of Progenics and Lantheus filed with the Securities
and Exchange Commission (SEC) on March 19, 2020.
- Impact of COVID-19 Pandemic
on Business OperationsThe Company today provided an update
on its efforts to mitigate the impact of the novel coronavirus
(COVID-19) global pandemic on its business operations. Progenics is
committed to complying with all government, regulatory and public
health recommendations in relation to COVID-19, and is taking
proactive steps to maintain operations, preserve the integrity of
its ongoing clinical study for 1095 and manage capital.For the
AZEDRA franchise, Progenics is continuing to receive and process
requests for both dosimetry and therapeutic doses. However, in
alignment with government, regulatory and public health
recommendations in relation to the COVID-19 pandemic, many of the
multidisciplinary treatment centers that serve pheochromocytoma or
paraganglioma patients have banned, or have limited access to,
external visitors, including the field-based sales team for AZEDRA,
to ensure the safety of patients and healthcare providers.
Consequently, the Company expects corresponding product revenue to
reflect the challenging environment associated with the COVID-19
pandemic until restrictions are lifted.Progenics has also paused
new enrollment for several months in the ongoing Phase 2 ARROW
trial of I-131-1095 (1095) in combination with enzalutamide in
chemotherapy-naïve patients with metastatic castration-resistant
prostate cancer (mCRPC) to minimize the risks to patients and
healthcare providers during the pandemic. Progenics is committed to
ensuring adequate safety monitoring of the ARROW patients and
maintaining the integrity of the trial in alignment with the newly
released U.S. Food and Drug Administration (FDA) guidance on
Conduct of Clinical Trials of Medical Products during COVID-19
pandemic. For patients who are active and have been randomized for
the study, they will continue to receive treatment doses and will
be monitored for safety and efficacy in a manner that is
permissible by each clinical site.As a result, the Company has
furloughed a portion of the clinical, commercial, and medical
employees to support cost saving measures as the Company continues
to navigate through the changing COVID-19 environment.The Company
has not experienced disruptions in its preparations to file a New
Drug Application (NDA) for PyL and reiterates its plan to complete
a submission early in the third quarter of 2020.Progenics continues
to assess this emerging situation and will make any relevant
adjustments when necessary.
AZEDRA (iobenguane I 131) 555 MBq/mL injection
for intravenous use, Ultra-orphan Radiotherapeutic
- AZEDRA Commercial Update First quarter sales
of AZEDRA totaled approximately $1.4 million. Sales of therapeutic
doses of AZEDRA doubled over the preceding quarter.
- AZEDRA Data Highlighted in
the Journal of Urology Updated long-term follow up
efficacy and safety data from the pivotal Phase 2 study of AZEDRA
in patients with pheochromocytoma or paraganglioma were published
as an abstract in the Journal of Urology. Results as of October 10,
2019, demonstrated a median overall survival (OS) time of 43.2
months (95% CI 31.4, >60), as well as a median survival time of
19.3 months (95% CI 4.5, 32.4) and 49.1 months (95% CI 36.9,
>60) in patients receiving one and two doses, respectively.
Continued Progress Across Entire PSMA-Targeted
Prostate Cancer Pipeline
- PyL NDA On Track for
Submission for Early Third Quarter 2020Progenics recently
completed two successful pre-NDA meetings with the FDA and remains
on track to complete a submission early in the third quarter of
2020. Based on prior discussions with the FDA, Progenics believes
that the data from the CONDOR study and the OSPREY study can serve
as the basis for an NDA for PyL.
- PyL Data Highlighted in the
Journal of UrologySeveral abstracts pertaining to PyL were
recently published in the Journal of Urology, including the results
of the Phase 3 CONDOR study in patients with biochemical recurrent
prostate cancer. The CONDOR trial achieved its primary endpoint,
with a correct localization rate (CLR) of 84.8% to 87.0% among the
three blinded independent readers (the lower bound of the 95%
confidence intervals ranging from 77.8% to 80.4%). The results of
additional investigator-sponsored studies of PyL conducted in
post-prostatectomy patients and metastatic clear cell renal cell
carcinoma were also published in the journal.
- Phase 2 Trial of 1095 New
Enrollment PausedFollowing the removal of the import alert
on Centre for Probe Development & Commercialization (CPDC), we
have initiated eleven clinical sites in the U.S along with the six
active sites in Canada to support enrollment in the Company’s
multicenter, randomized, controlled, ARROW Phase 2 study in mCRPC.
As a result of the potential impact of the pandemic on the patient
safety and study integrity, Progenics has decided to temporarily
place all enrollment of new patients on hold. Progenics’1095 is a
small molecule radiotherapeutic designed to selectively bind to the
extracellular domain of PSMA, a protein that is highly expressed on
prostate cancer cells.
Digital Technology
- CE Marking Received for
Automated Bone Scan Index (aBSI) in Europe The aBSI
automatically segments the anatomical regions of the skeleton and
detects and classifies lesions in the bone scan of prostate cancer
patients. The aBSI has been shown to be an objective measure of the
quantitative change in disease burden and is a prognostic biomarker
in patients with metastatic prostate cancer, and may alter the way
cancer patient data is utilized in physician decision making.
During this quarter, the Company received CE marking for the
standalone workstation model of aBSI, meeting the quality standards
set by the European Economic Area. This certification provides
additional support for the aBSI product launch.
RELISTOR, Treatment for Opioid-Induced
Constipation (partnered with Bausch Health Companies, Inc.)
- First Quarter 2020 RELISTOR
Worldwide Net Sales of $31.9 MillionThe first quarter 2020
worldwide net sales of RELISTOR, as reported by its partner Bausch
Health Companies, Inc. (formerly known as Valeant Pharmaceuticals,
Inc.), translated to approximately $4.8 million in royalty revenue
for Progenics for the quarter, up 15% over the first quarter of
2019.
First Quarter 2020 Financial
Results
First quarter revenue totaled $6.2 million, up
from $4.3 million in the first quarter of 2019, reflecting RELISTOR
royalty income of $4.8 million compared to $4.2 million in the
corresponding period of 2019 and $1.4 million of AZEDRA net
sales.
First quarter research and development expenses
decreased by $2.0 million compared to the corresponding prior year
period, resulting primarily from lower clinical costs and costs to
transition the AZEDRA manufacturing site in the 2019 period. First
quarter selling, general and administrative expenses increased by
$1.3 million compared to the corresponding prior year period,
primarily attributable to legal and advisory fees associated with
the execution of the amended merger agreement with Lantheus.
Progenics also recorded non-cash adjustments of $0.3 million in the
first quarter 2020, related to changes in the fair value estimate
of the contingent consideration liability. For the three months
ended March 31, 2020, Progenics recognized interest expense of $0.9
million related to the RELISTOR royalty-backed loan.
Net loss for the first quarter was $16.8
million, or $0.19 per diluted share, compared to net loss of $18.7
million, or $0.22 per diluted share, in the corresponding 2019
period.
Progenics ended the first quarter with cash and
cash equivalents of $29.5 million, a decrease of $12.5 million
compared to cash and cash equivalents as of December 31, 2019,
reflecting primarily cash used for operating expenses and capital
expenditures partially off-set by the receipt of the $10 million
RELISTOR sales milestone.
Conference Call and Webcast
Progenics will review first quarter 2020 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 7359368. 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.
-Financial Tables follow -
|
PROGENICS PHARMACEUTICALS,
INC.CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except per share data) |
|
For the Three Months EndedMarch
31, |
|
|
2020 |
|
|
2019 |
|
Revenues: |
(unaudited) |
Product sales |
$ |
1,359 |
|
$ |
- |
|
Royalty income |
|
4,789 |
|
|
4,161 |
|
License and other
revenues |
|
100 |
|
|
120 |
|
Total revenues |
|
6,248 |
|
|
4,281 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Cost of goods sold |
|
1,558 |
|
|
- |
|
Research and
development |
|
10,367 |
|
|
12,392 |
|
Selling, general and
administrative |
|
10,509 |
|
|
9,224 |
|
Change in contingent
consideration liability |
|
(300 |
) |
|
900 |
|
Total operating expenses |
|
22,134 |
|
|
22,516 |
|
|
|
|
|
|
|
|
Operating loss |
|
(15,886 |
) |
|
(18,235 |
) |
|
|
|
|
|
|
|
Other (expense) income: |
|
|
|
|
|
|
Interest (expense) income
and other income, net |
|
(915 |
) |
|
(500 |
) |
Total other (expense) income |
|
(915 |
) |
|
(500 |
) |
|
|
|
|
|
|
|
Net loss |
$ |
(16,801 |
) |
$ |
(18,735 |
) |
|
|
|
|
|
|
|
Net loss per share –
basic and diluted |
$ |
(0.19 |
) |
$ |
(0.22 |
) |
Weighted average shares
outstanding – basic and diluted |
|
86,582 |
|
|
84,542 |
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS(In
thousands) |
|
|
March 31, 2020 |
|
December 31, 2019 |
|
|
(unaudited) |
|
(audited) |
Cash and cash equivalents |
$ |
29,531 |
$ |
42,049 |
Accounts receivable, net |
|
6,190 |
|
15,976 |
Property and equipment, net |
|
14,673 |
|
11,688 |
Intangible assets, net and
goodwill |
|
24,394 |
|
24,670 |
Operating right-of-use lease
assets |
|
13,279 |
|
13,493 |
Other assets |
|
10,277 |
|
11,594 |
Total assets |
$ |
98,344 |
$ |
119,470 |
|
|
|
|
|
Current liabilities |
$ |
19,099 |
$ |
22,068 |
Contingent consideration
liability |
|
3,600 |
|
3,900 |
Operating lease liability |
|
14,832 |
|
15,005 |
Long-term debt, deferred tax and
other liabilities |
|
30,200 |
|
31,944 |
Total liabilities |
|
67,731 |
|
72,917 |
Total stockholders’ equity |
|
30,613 |
|
46,553 |
Total liabilities and stockholders’ equity |
$ |
98,344 |
$ |
119,470 |
|
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 filed with the SEC a registration statement on
Form S-4 on November 12, 2019, as amended by Amendment
No. 1 to that registration statement filed with the SEC on March
16, 2020, that includes a joint proxy statement of Lantheus and
Progenics that also constitutes a preliminary prospectus of
Lantheus. The registration statement was declared effective by the
SEC on March 18, 2020, and Progenics and Lantheus commenced mailing
the joint proxy statement/prospectus to stockholders of Progenics
and Lantheus on or about March 19, 2020. INVESTORS AND
SECURITY HOLDERS OF LANTHEUS 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 or Progenics through the website maintained by the SEC at
https://www.sec.gov.
Copies of the documents filed with the SEC by
Lantheus are or will also be available free of charge on Lantheus’
website at https://www.lantheus.com/ or by contacting Lantheus’
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, 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 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 and its definitive proxy
statement for its 2020 annual meeting of stockholders, which was
filed with the SEC on March 12, 2020. Other information regarding
the participants of Lantheus 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, 2019, which was
filed with the SEC on March 13, 2020. 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 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 COVID-19 pandemic and the measures taken to prevent its
spread and the related impact on our business; the proposed merger
transaction with Lantheus; 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 SEC, including those risk factors included in its
Annual Report on Form 10-K for the year ended December 31, 2019, as
updated in its subsequent Quarterly Reports on Form 10-Q. 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)
ContactMelissa DownsInvestor
Relations(646) 975-2533mdowns@progenics.com
Progenics Pharmaceuticals (NASDAQ:PGNX)
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Progenics Pharmaceuticals (NASDAQ:PGNX)
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From Jan 2024 to Jan 2025