Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  Nasdaq  >  Progenics Pharmaceuticals, Inc.    PGNX

PROGENICS PHARMACEUTICALS, INC.

(PGNX)
  Report  
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsOfficial PublicationsSector newsAnalyst Recommendations

PROGENICS PHARMACEUTICALS : Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)

share with twitter share with LinkedIn share with facebook
share via e-mail
0
08/09/2019 | 04:07pm EDT
The following Management's Discussion and Analysis of Financial Condition and
Results of Operations ("MD&A") is intended to assist the reader in understanding
the business of Progenics Pharmaceuticals, Inc. and its subsidiaries (the
"Company", "Progenics", "we", or "us"). MD&A is provided as a supplement to, and
should be read in conjunction with, our Annual Report on Form 10-K for the year
ended December 31, 2018. Our results of operations discussed in MD&A are
presented in conformity with accounting principles generally accepted in the
U.S. ("GAAP"). We operate under a single research and development business
segment. Therefore, our results of operations are discussed on a consolidated
basis.


Note Regarding Forward-Looking Statements




This document and other public statements we make may contain statements that do
not relate strictly to historical fact, any of which may be forward-looking
statements within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995. Statements contained in this communication that refer to our
estimated or anticipated future results or other non-historical facts are
forward-looking statements that reflect our current perception 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. In evaluating such statements, we urge you to specifically consider
the various risk factors identified under Part I, Item 1A. "Risk Factors"
included in our Annual Report on Form 10-K for the year ended December 31, 2018,
as updated by our subsequent Quarterly Reports on Form 10-Q, which could cause
actual events or results to differ materially from those indicated by
forward-looking statements. Forward-looking statements involve known and unknown
risks and uncertainties which may cause our actual results, performance or
achievements to be materially different from those expressed or implied by such
statements. While it is impossible to identify or predict all such matters,
these differences between forward-looking statements and our actual results,
performance or achievement may result from, among other things; the inherent
uncertainty of the timing and success of, and expense associated with, research,
development, regulatory approval and commercialization of our products and
product candidates, including the risks that clinical trials will not commence
or proceed as planned; products which appear to be promising in early trials
will not demonstrate efficacy or safety in larger-scale trials; clinical trial
data on our products and product candidates will be unfavorable; our products
will not receive marketing approval from regulators or, if approved, do not gain
sufficient market acceptance to justify development and commercialization costs;
the sales of RELISTOR® and other products by our partners and the revenue and
income generated for us thereby may not meet expectations; our commercial launch
of AZEDRA® may not meet revenue and income expectations; competing products
currently on the market or in development might reduce the commercial potential
of our products; we, our collaborators or others might identify side effects
after the product is on the market; efficacy or safety concerns regarding
marketed products, whether or not originating from subsequent testing or other
activities by us, governmental regulators, other entities or organizations or
otherwise, and whether or not scientifically justified, may lead to product
recalls, withdrawals of marketing approval, reformulation of the product,
additional pre-clinical testing or clinical trials, changes in labeling of the
product, the need for additional marketing applications, declining sales, or
other adverse events; the inherent uncertainty of outcomes in intellectual
property disputes such as the dispute with University of Heidelberg regarding
PSMA-617; the costs and management distraction attendant to activist stockholder
campaigns; and risks related to changes in the composition of our Board of
Directors following our most recent annual meeting of stockholders.



We are also subject to risks and uncertainties associated with the actions of
our corporate, academic and other collaborators and government regulatory
agencies, including risks from market forces and trends; potential product
liability; intellectual property, litigation and other dispute resolution,
environmental and other risks; a potential inability to obtain sufficient
capital, recruit and retain employees, enter into favorable collaborations,
transactions, or other relationships, or the risk that existing or future
relationships or transactions may not proceed as planned; the potential for
cybersecurity breaches of our systems and information technology; the risk that
current and pending patent protection for our products may be invalid,
unenforceable or challenged, or fail to provide adequate market exclusivity, or
that our rights to in-licensed intellectual property may be terminated for our
failure to satisfy performance milestones; the risk of difficulties in, and
regulatory compliance relating to, manufacturing products; and the uncertainty
of our future profitability.



Risks and uncertainties to which we are subject also include general economic
conditions, including interest and currency exchange-rate fluctuations and the
availability of capital; changes in generally accepted accounting principles;
the impact of legislation and regulatory compliance; the highly regulated nature
of our business, including government cost-containment initiatives and
restrictions on third-party payments for our products; trade buying patterns;
the competitive climate of our industry; and other factors set forth in this
document and other reports filed with the U.S. Securities and Exchange
Commission ("SEC"). In particular, we cannot assure you that AZEDRA® or
RELISTOR® will be commercially successful or be approved in the future in other
indications or jurisdictions, or that any of our other programs will result in a
commercial product.



                                       27

--------------------------------------------------------------------------------

Table of Contents




We do not have a policy of updating or revising forward-looking statements and,
except as expressly required by law, we disclaim any intent or obligation to
update or revise any statements as a result of new information or future events
or developments. It should not be assumed that our silence over time means that
actual events are bearing out as expressed or implied in forward-looking
statements.



Overview



Business



We are an oncology company focused on the development and commercialization of
innovative targeted medicines and artificial intelligence to find, fight and
follow cancer. Highlights of our recent progress include the first commercial
revenue for AZEDRA, completion of enrollment of the PyL pivotal Phase 3 trial,
and dosing of the first patient in the 1095 open label Phase 2 trial. Our
pipeline includes therapeutic agents designed to precisely target cancer
(AZEDRA, 1095 and PSMA TTC), as well as a prostate-specific membrane antigen
("PSMA") targeted imaging agents for prostate cancer (PyL and 1404).



Our business strategy requires us to manage our business to provide for the
continued development, manufacturing and potential commercialization of our
proprietary and partnered product candidates. This includes identifying and
advancing a pipeline of product candidates by identifying product candidates,
technologies and businesses for acquisition and in-licensing that we believe are
a strategic fit with our existing business.



Our strategy also calls for us to undertake increased research and development
activities and to manage an increasing number of relationships with partners and
other third parties, while simultaneously managing the capital necessary to
support this strategy. An element of our research and development strategy has
been to in-license technology and product candidates.



We may consider opportunities to out-license our development and clinical programs or to in-license or acquire additional oncology compounds and/or programs. We may also consider other strategic transactions from time to time that are consistent with our business strategy and objectives.



Product / Candidate   Description                       Status        Market    Rights
Ultra-Orphan
Theranostic
AZEDRA (iobenguane    Unresectable, locally            Approved        U.S     Progenics
I 131)                advanced or metastatic
555 MBq/mL            pheochromocytoma or
injection             paraganglioma
Prostate Cancer
Theranostics
PyL (18F-DCFPyL)      PSMA-targeted PET/CT            Enrollment    Worldwide  Progenics
                      imaging agent for prostate       Completed     (ex. EU,
                      cancer                          in Phase 3    AU, & NZ)
PyL (18F-DCFPyL)      PSMA-targeted PET/CT           Meeting with     Europe    Curium
                      imaging agent for prostate          EMA
                      cancer
1095 (I 131 1095)     PSMA-targeted small               Phase 2     Worldwide  Progenics
                      molecule therapeutic for
                      treatment of metastatic
                      prostate cancer
PSMA TTC (BAY         PSMA-targeted antibody            Phase 1     Worldwide    Bayer
2315497)              conjugate therapeutic for
                      treatment of metastatic
                      prostate cancer
1404                  Technetium-99m                 Meeting with     Europe     ROTOP
                      PSMA-targeted SPECT/CT              EMA
                      imaging agent for prostate
                      cancer
Digital Technology
PSMA AI               Imaging analysis technology   Investigational Worldwide  Progenics
                      that uses artificial             Use Only
                      intelligence and machine
                      learning to quantify and
                      automate the reading of
                      PSMA targeted imaging
Automated Bone Scan   Automated reading and          CE marked (EU  Worldwide  Progenics
Index (aBSI)          quantification of bone          countries)       (ex.
                      scans of prostate cancer      510(k) cleared    Japan)
                      patients using artificial       in the U.S.
                      intelligence and deep
                      learning
Automated Bone Scan   Automated reading and            Approved       Japan    FUJIFILM
Index (BONENAVI)      quantification of bone
                      scans of prostate cancer
                      patients using artificial
                      intelligence and deep
                      learning
Other Programs
RELISTOR              OIC in adults with chronic       Approved     Worldwide   Bausch
Subcutaneous          non-cancer pain or
Injection             advanced-illness adult
(methylnaltrexone     patients
bromide)
RELISTOR Tablets      OIC in adults with chronic       Approved        U.S.     Bausch
(methylnaltrexone     non-cancer pain
bromide)
Leronlimab (PRO       HIV Infection                   Rolling BLA      U.S.     CytoDyn
140)                                                 Submission to
                                                          FDA




                                       28

--------------------------------------------------------------------------------

  Table of Contents



Ultra-Orphan Theranostic:


? AZEDRA® (iobenguane I 131) is a radiotherapeutic, approved 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. AZEDRA is the first and

only FDA-approved therapy for this indication. We anticipate opportunities for

growth of AZEDRA beyond its existing label through the development of new

    indications.




Prostate Cancer Theranostics:



? PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted PET imaging

agent that enables visualization of both bone and soft tissue metastases to

determine the presence or absence of recurrent and/or metastatic prostate

cancer. In the U.S. and Canada, we completed enrollment of the pivotal Phase 3

trial evaluating the diagnostic performance and clinical impact of PyL in men

with biochemical recurrence of prostate cancer. Curium has licensed exclusive

rights to develop and commercialize PyL in Europe.

? 1095 (also known as I-131-1095) is a PSMA-targeted Iodine-131 labeled small

molecule that is designed to deliver a dose of beta radiation directly to

prostate cancer cells with minimal impact on the surrounding healthy tissues.

We are conducting a Phase 2 clinical trial in combination with enzalutamide in

chemotherapy-naïve patients with metastatic castration-resistant prostate

cancer (mCRPC).

? PSMA TTC is a thorium-227 labeled PSMA-targeted antibody therapeutic. PSMA TTC

is designed to deliver a dose of alpha radiation directly to prostate cancer

cells with minimal impact on the surrounding healthy tissues. Bayer AG

("Bayer") has exclusive worldwide rights to develop and commercialize products

using our PSMA antibody technology in combination with Bayer's alpha-emitting

radionuclides. Bayer is developing PSMA TTC, a thorium-227 labeled

PSMA-targeted antibody therapeutic. Bayer is conducting a Phase 1 trial of

PSMA TTC in patients with metastatic castration-resistant prostate cancer.

? 1404 is a technetium-99m labeled small molecule which binds to PSMA and is

used as an imaging agent to diagnose and detect localized prostate cancer as

well as soft tissue and bone metastases. ROTOP Pharmaka GmbH ("ROTOP"), a

Germany-based developer of radiopharmaceuticals for nuclear medicine

diagnostics, has exclusive rights to develop and commercialize 1404 in Europe.





Digital Technology:



? PSMA AI is an imaging analysis technology that uses artificial intelligence

and machine learning to quantify and automate the reading of PSMA-targeted

imaging. We recently completed a performance study of our automated

segmentation algorithms with PyL/CT images from our PyL research access

initiative. The results from this analysis will be presented at an upcoming

scientific conference.

? Automated Bone Scan Index (aBSI) calculates the disease burden of prostate

cancer by quantifying the hotspots on bone scans and automatically calculating

the bone scan index value, representing the disease burden of prostate cancer

shown on the bone scan. This quantifiable and reproducible calculation of the

bone scan index value is intended to aid in the diagnosis and treatment of men

with prostate cancer and may have utility in monitoring the course of the

disease. The Japanese rights to aBSI have been transferred and sold to

FUJIFILM Toyama Chemical Co, Ltd. ("FUJIFILM") under the name BONENAVI®. The

cloud based aBSI 510(k) was cleared by the FDA for clinical use in the U.S. on

    August 5, 2019.




Other Programs:



? RELISTOR® is a treatment for opioid-induced constipation ("OIC") that

addresses its underlying mechanism of OIC and decreases the constipating side

effects induced by opioid pain medications such as morphine and codeine

without diminishing their ability to relieve pain. RELISTOR is approved in two

forms: a subcutaneous injection (12 mg and 8 mg) and an oral tablet (450 mg

once daily). Any references herein to RELISTOR do not imply that any other

form or possible use of the drug has received approval. RELISTOR subcutaneous

injection is being sold in the U.S., European Union ("E.U."), and Canada, and

RELISTOR tablets are being sold in the U.S. RELISTOR's approved U.S. label and

full U.S. prescribing information is available at www.RELISTOR.com. Other

approved labels for RELISTOR apply in ex-U.S. markets.

? Leronlimab (PRO 140) is a fully humanized monoclonal antibody which is a

cellular targeting CCR5 entry antagonist and is currently in Phase 3

development for the treatment of HIV infection. It is owned by CytoDyn and,

pursuant to our agreement with CytoDyn, we have the right to receive certain

milestone and royalty payments. CytoDyn announced in March 2019 that it filed

its first of three sections of its Biologics License Application ("BLA") to

the FDA for leronlimab for the treatment of HIV under the Rolling Review

    process.




                                       29

--------------------------------------------------------------------------------

  Table of Contents



Bausch Agreement



Under our agreement with Salix Pharmaceuticals, Inc., a wholly-owned subsidiary
of Bausch Health Companies Inc. ("Bausch", which is the predecessor of Valeant
Pharmaceuticals International, Inc.), we received a development milestone of
$40.0 million upon U.S. marketing approval for subcutaneous RELISTOR in
non-cancer pain patients in 2014, and a development milestone of $50.0 million
for the U.S. marketing approval of an oral formulation of RELISTOR in 2016. We
are also eligible to receive up to $200.0 million of commercialization milestone
payments upon first achievement of specified U.S. net sales targets in any
single calendar year. The following table summarizes the commercialization
milestones:



U.S. Net Sales Levels in any Single Calendar Year Payment

                                                     (In thousands)
In excess of $100 million                           $         10,000
In excess of $150 million                                     15,000
In excess of $200 million                                     20,000
In excess of $300 million                                     30,000
In excess of $750 million                                     50,000
In excess of $1 billion                                       75,000
                                                    $        200,000




Each commercialization milestone payment is payable one time only, regardless of
the number of times the condition is satisfied, and all six payments could be
made within the same calendar year. We are also eligible to receive royalties
from Bausch and its affiliates based on the following royalty scale: 15% on
worldwide net sales up to $100 million, 17% on the next $400 million in
worldwide net sales, and 19% on worldwide net sales over $500 million each
calendar year, and 60% of any upfront, milestone, reimbursement or other revenue
(net of costs of goods sold, as defined, and territory-specific research and
development expense reimbursement) Bausch receives from sublicensees outside the
U.S.



Bayer Agreement



Under our April 2016 agreement with a subsidiary of Bayer granting Bayer
exclusive worldwide rights to develop and commercialize products using our PSMA
antibody technology, we received an upfront payment of $4.0 million and
milestone payments totaling $5.0 million and could receive up to an additional
$44.0 million in potential clinical and regulatory development milestones. We
are also entitled to single-digit royalties on net sales, and potential net
sales milestone payments up to an aggregate total of $130.0 million.



CytoDyn Agreement



We sold Leronlimab (PRO 140) to CytoDyn Inc. ("CytoDyn") in 2012, which sale
included milestone and royalty payment obligations to us. Leronlimab is a fully
humanized monoclonal antibody which is a cellular targeting CCR5 entry
antagonist and is currently in development for the treatment of HIV.



Under our 2012 agreement with CytoDyn, CytoDyn is responsible for all
development, manufacturing and commercialization efforts. Pursuant to such
agreement, we have received $5.0 million in upfront and milestone payments,
together with rights to receive an additional $5.0 million upon the first U.S.
or E.U. approval for the sale of the drug, and a 5% royalty on the net sales of
approved product(s).



                                       30

--------------------------------------------------------------------------------

  Table of Contents



ROTOP Agreement


We entered into an exclusive license agreement with ROTOP, a Germany-based developer of radiopharmaceuticals for nuclear medicine diagnostics, to develop and commercialize 1404 in Europe.

Under the terms of the collaboration, ROTOP will be responsible for the development, regulatory approvals and commercialization of 1404 in Europe while Progenics is entitled to double-digit, tiered royalties on net sales in the territory.




FUJIFILM Agreement



We entered into a transfer agreement with FUJIFILM for the rights to the Company's aBSI product in Japan for use under the name BONENAVI.




Under the terms of the agreement, FUJIFILM acquired, by a combination of
purchase and license, the Japanese software, source code, supporting data and
all Japanese patents associated with the aBSI product from Progenics for use in
Japan. In exchange, Progenics received $4.0 million in an upfront payment and
FUJIFILM agreed to pay Progenics support and service fees for aBSI and other AI
products over three years in Japan. BONENAVI has been licensed to FUJIFILM for
use in Japan since 2011.



Results of Operations


The following table is an overview of our results of operations (in thousands, except percentages):



                       Three Months Ended                       Six Months Ended
                            June 30,                                June 30,
                       2019          2018        Change        2019          2018        Change
Total revenue        $   9,966$   3,878         157 %   $  14,247$   7,067         102 %
Operating expenses   $  29,059$  18,216        (60% )   $  51,575$  33,823        (52% )
Operating loss       $ (19,093 )$ (14,338 )      (33% )   $ (37,328 )$ (26,756 )      (40% )
Net loss             $ (19,700 )$ (15,172 )      (30% )   $ (38,435 )$ (28,596 )      (34% )




Revenue



Our sources of revenue include AZEDRA product sales, royalties and license fees
from Bausch and other collaborators. The following table is a summary of our
worldwide revenue (in thousands, except percentages):



                              Three Months Ended                      Six Months Ended
                                   June 30,                               June 30,
Source                         2019          2018       Change        2019         2018       Change
AZEDRA product sales        $      270      $     -         N/A     $     270     $     -         N/A
Royalty income                   3,593        3,530           2 %       7,754       6,588          18 %
License and other revenue        6,103          348        1654 %       6,223         479        1199 %
Total revenue               $    9,966$ 3,878         157 %   $  14,247$ 7,067         102 %



AZEDRA product sales. In June 2019 we recorded our first commercial product sales of AZEDRA in the U.S. (no sales-related deductions or discounts were applicable to the June 2019 sales). There were no sales of AZEDRA for the three and six months ended June 30, 2018, as AZEDRA was not approved until July 2018.




                                       31

--------------------------------------------------------------------------------

Table of Contents




Royalty income. We recognized royalty income primarily based on the below net
sales of RELISTOR, as reported to us by Bausch (in thousands, except
percentages).



                               Three Months Ended                        Six Months Ended
                                    June 30,                                 June 30,
                               2019          2018         Change        2019          2018         Change
U.S.                        $   23,800$  23,500            1 %   $  50,200$  43,800           15 %
Outside U.S.                       200             -          N/A         1,500           100         1400 %
Worldwide net sales of
RELISTOR                    $   24,000$  23,500            2 %   $  51,700$  43,900           18 %




Royalty income increased by $0.1 million, or 2%, during the three months ended
June 30, 2019, compared to the same period in 2018, and by $1.2 million, or 18%
during the six months ended June 30, 2019, compared to the same period in 2018,
due primarily to higher net sales.



License and other revenue. The license and other revenue increased by $5.8 million and $5.7 million for the three and six months ended June 30, 2019, respectively, compared to the same periods in 2018. These increases were primarily due to the achievement of a $2.0 million milestone under the Bayer agreement for initiation of a Phase 1 trial of PSMA TTC and a $4.0 million upfront payment from FUJIFILM under the aBSI agreement.



Operating Expenses



The following table is a summary of our operating expenses (in thousands, except
percentages):



                               Three Months Ended                        Six Months Ended
                                    June 30,                                 June 30,
Operating Expenses             2019          2018         Change        2019          2018         Change
Cost of goods sold          $      493     $       -          N/A     $     493     $       -          N/A
Research and development        13,080         9,347         (40% )      25,472        17,457         (46% )
Selling, general and
administrative                  14,570         7,569         (92% )      23,794        14,266         (67% )
Change in contingent
consideration liability            916         1,300           30 %       1,816         2,100           14 %
Total operating expenses    $   29,059$  18,216         (60% )   $  51,575$  33,823         (52% )




Cost of Goods Sold ("COGS")



COGS includes cost of direct materials and labor and indirect expenses used in
the manufacturing of AZEDRA beginning with the first commercial sale in June
2019.


Research and Development ("R&D")




We do not track fully burdened R&D costs separately for each of our product
candidates. We review our R&D expenses by focusing on external and internal
development costs. External development costs consist of costs associated with
our clinical trials, including pharmaceutical development and manufacturing of
clinical trial materials. Included in other costs are external corporate
overhead costs that are not specific or allocated to any one program. Internal
costs consist of salaries and wages, share-based compensation and benefits,
which are not tracked by program as several of our departments support multiple
development programs. The following table summarizes the external costs
attributable to each program and internal costs (in thousands):



                                  Three Months Ended June 30,             Six Months Ended June 30,
                                    2019                2018              2019                2018
External Costs
PyL                            $        3,996$       2,578$       7,148$       4,168
AZEDRA                                  1,758               1,203             5,469               2,373
1404                                       89                 679               216               1,964
1095                                    2,085                 187             2,963                 570
PSMA AI                                   291                 428               598                 598
Other                                   1,551               1,212             2,196               1,374
Total External Costs           $        9,770$       6,287$      18,590$      11,047
Internal Costs                          3,310               3,060             6,882               6,410
Total R&D Costs                $       13,080$       9,347$      25,472$      17,457




                                       32

--------------------------------------------------------------------------------

Table of Contents




R&D expenses increased by $3.7 million, or 40%, during the three months ended
June 30, 2019, compared to the same period in 2018, primarily resulting from
higher clinical trial and contract manufacturing costs for clinical trial
materials for 1095 and PyL, as well as higher costs associated with the
transition for the AZEDRA manufacturing site and additional production capacity
for iodine-based products. R&D expenses increased by $8.0 million, or 46%,
during the six months ended June 30, 2019, compared to the same period in 2018,
primarily due to higher costs associated with the transition for the AZEDRA
manufacturing site and additional production capacity for iodine-based products,
higher clinical trial and contract manufacturing costs for clinical trial
materials for 1095 and PyL, partially offset by lower clinical trial costs for
1404.


Selling, General and Administrative ("SG&A")




SG&A expenses increased by $7.0 million, or 92% and $9.5 million, or 67%, during
the three and six months ended June 30, 2019, respectively, compared to the same
periods in 2018. The three and six months increases were primarily due to higher
legal and advisory fees of $5.5 million and $5.9 million, respectively,
associated with the contested election at our 2019 Annual Meeting of
Shareholders, higher PSMA-617 litigation costs of $1.0 million and $1.8 million,
respectively, and higher costs associated with the buildout of commercial
infrastructure to support the launch and distribution of AZEDRA.



Change in Contingent Consideration Liability




The change in the contingent consideration liability of $0.9 million during the
three months ended June 30, 2019 was primarily attributable to an increase in
the AZEDRA sales forecasts associated with the planned initiation of a basket
study to expand the label for AZEDRA, which is used to calculate the potential
milestone payments to former MIP stockholders, compared to a change of $1.3
million in the same period in 2018, resulting primarily from higher estimated
probability of success of AZEDRA. The contingent consideration liability
increased by $1.8 million during the six months ended June 30, 2019, primarily
due to an increase in the AZEDRA sales forecasts associated with the planned
initiation of a basket study to expand the label for AZEDRA and first quarter
increase in the probability of success for the AZEDRA commercialization
milestone. The contingent consideration liability increased by $2.1 million
during the six months ended June 30, 2018, primarily due to a higher estimated
probability of success of AZEDRA.



Other (Expense) Income



The following table is a summary of our other (expense) income (in thousands,
except percentages):



                           Three Months Ended                             Six Months Ended
                                June 30,                                      June 30,
                         2019              2018          Change         
2019           2018         Change
Interest (expense)
income, net           $      (538 )$      (856 )          37 %   $     (967 )$   (1,799 )          46 %
Other (expense)
income, net                   (69 )             (74 )           7 %         (140 )         (137 )          (2 %)
Other (expense)
income                $      (607 )$      (930 )          35 %   $   (1,107 )$   (1,936 )          43 %



Total other (expense) income, net decreased by $0.3 million, or 35%, and $0.8 million, or 43%, during the three and six months ended June 30, 2019, respectively, compared to the same periods in 2018.

Liquidity and Capital Resources

The following table is a summary of selected financial data (in thousands):



                            June 30,       December 31,
                              2019             2018
Cash and cash equivalents   $  84,823$      137,686
Accounts receivable, net    $  10,569$        3,803
Total assets                $ 152,781$      169,497
Working capital             $  76,627$      120,683




                                       33

--------------------------------------------------------------------------------

Table of Contents




Our current principal sources of revenue from operations are royalties and
development and commercial milestones. Our principal sources of liquidity are
our existing cash and cash equivalents. As of June 30, 2019, we had cash and
cash equivalents of approximately $84.8 million, a decrease of $52.9 million
from $137.7 million at December 31, 2018, reflecting primarily cash used for
operating expenses and for the acquisition, transition and start-up costs of the
Somerset manufacturing site for the AZEDRA launch. We expect to continue to have
significant cash requirements to support product development activities and the
commercial launch of AZEDRA. The amount and timing of our cash requirements will
depend on the progress and success of our clinical development programs,
regulatory and market acceptance, and the resources we devote to research and
commercialization activities. The amount of cash on-hand will depend on the
progress of various clinical programs, potential sales from the launch of
AZEDRA, and the achievement of various milestones and royalties under our
existing license agreements.



We believe that our current cash and cash equivalents will be sufficient to fund
our operations for at least the next twelve months. We expect to fund our
operations going forward with existing cash resources, anticipated revenues from
our existing license agreements, sales of AZEDRA, and cash that we may raise
through future capital raising and other financing transactions.



If we do not realize sufficient royalty or milestone revenue from our license
agreements, sales of AZEDRA, or are unable to enter into favorable
collaboration, license, asset sale, additional capital raising, or other
financing transactions, we will have to reduce, delay, or eliminate spending on
certain programs, and/or take other economic measures.



Cash Flows



The following table is a summary of our cash flow activities (in thousands):



                                                         Six Months Ended
                                                             June 30,
                                                        2019          2018
Net cash used in operating activities                 $ (38,700 )$ (25,189 )
Net cash used in investing activities                 $ (10,104 )   $    

(502 ) Net cash (used in) provided by financing activities $ (2,323 )$ 22,636





Operating Activities



Net cash used in operating activities during the six months ended June 30, 2019 was primarily attributable to operating expenses, net of non-cash items including the change in fair value of contingent consideration liability.



Investing Activities


Net cash used in investing activities during the six months ended June 30, 2019 was primarily related to the acquisition of AZEDRA manufacturing assets in Somerset, New Jersey and capital expenditures at contract manufacturing organizations related to additional iodine manufacturing capacity.



Financing Activities



Net cash used in financing activities during the six months ended June 30, 2019
was primarily attributable to repayment of debt under the Royalty-Backed Loan
with HealthCare Royalty Partners III, L.P.

Off-Balance Sheet Arrangements and Guarantees

We have no obligations under off-balance sheet arrangements and do not guarantee the obligations of any other unconsolidated entity.



Critical Accounting Policies



We prepare our financial statements in conformity with accounting principles
generally accepted in the U.S. Our significant accounting policies are disclosed
in Note 2. Summary of Significant Accounting Policies to our consolidated
financial statements included in our Annual Report on Form 10-K for the year
ended December 31, 2018. The selection and application of these accounting
principles and methods requires us to make estimates and assumptions that affect
the reported amounts of assets, liabilities, revenues and expenses, as well as
certain financial statement disclosures. We evaluate these estimates on an
ongoing basis. We base these estimates on historical experience and on various
other assumptions that we believe reasonable under the circumstances. The
results of these evaluations form the basis for making judgments about the
carrying values of assets and liabilities that are not otherwise readily
apparent. While we believe that the estimates and assumptions we use in
preparing the financial statements are appropriate, they are subject to a number
of factors and uncertainties regarding their ultimate outcome and, therefore,
actual results could differ from these estimates.



                                       34

--------------------------------------------------------------------------------

Table of Contents

There have been no changes to our critical accounting policies and estimates as of and for the six months ended June 30, 2019 as noted in Management's Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2018.

Recent Accounting Developments




Refer to our discussion of recently adopted accounting pronouncements and other
recent accounting pronouncements in Note 2. New Accounting Pronouncements to the
accompanying unaudited condensed consolidated financial statements included
elsewhere in this Quarterly Report on Form 10-Q.

© Edgar Online, source Glimpses

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on PROGENICS PHARMACEUTICALS,
08/12PROGENICS PHARMACEUTICALS : Announces Second Quarter 2019 Financial Results and ..
AQ
08/12PROGENICS PHARMACEUTICALS : Velan Highlights Progenics Pharmaceuticals' Continue..
PR
08/09PROGENICS PHARMACEUTICALS : Management's Discussion and Analysis of Financial Co..
AQ
08/09PROGENICS PHARMACEUTICALS INC : Results of Operations and Financial Condition, R..
AQ
08/09PROGENICS : 2Q Earnings Snapshot
AQ
08/09Progenics Pharmaceuticals Announces Second Quarter 2019 Financial Results and..
GL
08/08PROGENICS PHARMACEUTICALS INC : Change in Directors or Principal Officers (form ..
AQ
08/08Progenics Pharmaceuticals Announces Additional Governance Enhancements
GL
08/07PROGENICS PHARMACEUTICALS : CMS Grants New Technology Add-On Payment for Inpatie..
AQ
08/06PROGENICS PHARMACEUTICALS : CMS Grants New Technology Add-On Payment for Inpatie..
AQ
More news