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Note 1 - Organization and Business
12 Months Ended
Dec. 31, 2019
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
1
. Organization and Business
 
 
Business
 
Progenics Pharmaceuticals, Inc. (and its subsidiaries collectively the “Company,” “Progenics”, “we”, or “us”) is 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 enrollment completion of our pivotal phase
3
trial for PyL and the positive topline results. 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
).
 
We commenced principal operations in
1988,
became publicly traded in
1997,
and throughout have been engaged primarily in research and development efforts, establishing corporate collaborations, launching and commercializing AZEDRA and other related business activities. Certain of our intellectual property rights are held by wholly-owned subsidiaries. Our U.S. operations are presently conducted at our headquarters in New York and our manufacturing facility in Somerset, New Jersey. The operations of our wholly-owned foreign subsidiary, EXINI Diagnostics A.B. (“EXINI”), are conducted at our facility in Lund, Sweden. We operate under a single operating segment, which includes development, manufacturing and commercialization of pharmaceutical products and other technologies to target, diagnose and treat cancer. Our operating segment is regularly evaluated for financial performance by our chief operating decision maker, who is our Chief Executive Officer.
 
Revenue
 
 
Our current principal sources of revenue from operations are AZEDRA product sales, royalty, development and commercial milestones from Bausch, Bayer and FUJIFILM. Royalty and further milestone payments from Bausch or Bayer depend on success in development and commercialization of RELISTOR and our PSMA antibody technology, respectively, which is dependent on many factors, such as Bausch or Bayer’s respective efforts, decisions by the FDA and other regulatory bodies, competition from drugs for the same or similar indications, and the outcome of clinical and other testing of the licensed products.
 
Liquidity
 
The Company is
not
profitable and there is
no
assurance that we will ever achieve and sustain profitability on a continuing basis. In addition, development activities, clinical testing, and commercialization of the Company’s product candidates will require additional financing. The Company’s accumulated deficit at
December 31, 2019
totaled
$677.8
million, and management expects to incur substantial losses in future periods. The success of the Company is subject to certain risks and uncertainties, including among others, uncertainty of product development and commercialization; uncertainty of capital availability; uncertainty in the Company’s ability to enter into agreements with collaborative partners; dependence on
third
parties; and dependence on key personnel.
 
We have historically funded our operations to a significant extent from capital-raising and we expect to require additional funding in the future, the availability of which is never guaranteed and
may
be uncertain. During
2018,
we raised net proceeds of
$70.0
million in an underwritten public offering of
9.1
million shares of common stock at a public offering price of
$8.25
per share. During
2018
and
2017
we raised an additional
$29.7
million and
$5.0
million, respectively, in at-the-market (“ATM”) transactions under a controlled equity offering sales agreement (“Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”). (See
Note
10.
Stockholders’ Equity
for additional information). During
2016,
we raised net proceeds of
$48.7
million through a royalty monetization transaction (See
Note
9.
Long-Term Debt, Net
for additional information).
 
At
December 31, 2019,
we had
$42.0
million in cash and cash equivalents, a decrease of
$95.7
million from
$137.7
million at
December 31, 2018.
On
February 20, 2020,
we announced the signing of an amended and restated definitive merger agreement for the proposed merger of Progenics with Lantheus Holdings. Consistent with regular practice for a growth-stage pharmaceutical or biotechnology company, and as we have done in the past, we anticipate obtaining additional financing in order to meet our cash requirements if the Lantheus Holdings agreement is
not
ultimately consummated. However, there can be
no
assurances that we will be able to obtain additional capital on acceptable terms and in the amounts necessary to fully fund our current operating expenses or reduced operating expenses reflecting delays or reductions in the scope of our product development programs beyond
one
year from the date this annual report is issued. As such, we believe there is substantial doubt regarding our ability to continue as a going concern within
one
year after the date this Annual Report on Form
10
-K is filed with the SEC. The financial statements do
not
include any adjustments relating to the recoverability and classification of liabilities that might be necessary should we be unable to continue as a going concern.