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Note 1 - Summary of Significant Accounting Policies
3 Months Ended
Mar. 31, 2018
Notes to Financial Statements  
Business Description and Accounting Policies [Text Block]
Note
1.
Summary of Significant Accounting Policies
 
Business
 
Progenics Pharmaceuticals, Inc. and its subsidiaries (“the Company,” “Progenics,” “we” or “us”) develop innovative medicines and other technologies to target and treat cancer. Our pipeline includes:
1
) therapeutic agents designed to precisely target cancer (AZEDRA
®
,
1095,
and PSMA TTC),
2
) PSMA-targeted imaging agents for prostate cancer (
1404
and PyL
TM
), and
3
) imaging analysis technology.
 
We licensed our
first
commercial drug, RELISTOR
®
(methylnaltrexone bromide) subcutaneous injection for the treatment of opioid induced constipation (“OIC”), to Salix Pharmaceuticals, Inc. (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc. (“Valeant”)). RELISTOR received an expanded approval from the U.S. Food and Drug Administration (“FDA”) for the treatment of OIC in patients taking opioids for chronic non-cancer pain, and in
July 2016,
RELISTOR Tablets were approved by the FDA for the treatment of OIC in adults with chronic non-cancer pain.
 
On
October 31, 2017,
we completed the rolling submission of our NDA for AZEDRA. The FDA has accepted our NDA for review, granted our request for Priority Review, and set an initial action date of
April 30, 2018
under the Prescription Drug User Fee Act (“PDUFA”), which was extended in
March
by
three
months to
July 30, 2018.
We are developing AZEDRA as a treatment for patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors. There are currently
no
approved therapies in the U.S. for these ultra-rare diseases. While AZEDRA has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA, there can be
no
assurance that our NDA will be approved.
 
We have in the past considered opportunities for strategic collaborations, out-licenses, and other arrangements with biopharmaceutical companies involving proprietary research, development and clinical programs, and we continue to do so. We
may
in the future also in-license or acquire additional oncology compounds and/or programs.
 
Our current principal sources of revenue from operations are royalty, development and commercial milestones from Valeant and Bayer AG (“Bayer”). Royalty and further milestone payments from Valeant or Bayer depend on success in development and commercialization, which is dependent on many factors, such as Valeant 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.
 
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, and related business activities. Certain of our intellectual property rights are held by wholly-owned subsidiaries. All of our U.S. operations are presently conducted at our headquarters in New York, and 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 research and development operating segment.
 
Liquidity
 
At
March 31, 2018,
we had
$83.4
million of cash and cash equivalents, a decrease of
$7.2
million from
$90.6
million at
December 31, 2017.
We expect that this amount will be sufficient to fund operations as currently anticipated beyond
one
year from the filing date of this Form
10
-Q. 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. We expect that we
may
continue to incur operating losses.
 
During the
first
quarter of
2018,
we raised net proceeds of
$9.5
million in at-the-market transactions under a controlled equity offering sales agreement (“Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”). (See
Note
10.
Stockholders’ Equity
for additional information).
 
Basis of Presentation
 
Our interim condensed consolidated financial statements have been prepared in accordance with applicable presentation requirements, and accordingly, do
not
include all information and disclosures necessary for a presentation of our financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the U.S. (“GAAP”). In the opinion of management, these financial statements reflect all adjustments, consisting primarily of normal recurring accruals necessary for a fair statement of results for the periods presented. The results of operations for interim periods are
not
necessarily indicative of the results for the full year.
 
Our interim condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in our Annual Report on Form
10
-K for the year ended
December 31, 2017.
The year-end consolidated balance sheet data in these financial statements were derived from audited financial statements but do
not
include all disclosures required by GAAP. Certain prior period amounts in our condensed consolidated financial statements have been reclassified to conform to the current period presentation.
 
Reclassifications
 
On
January 1, 2018,
we adopted Accounting Standards Update (ASU)
No.
2016
-
18
(“ASU
2016
-
18”
),
Statement of Cash Flows (Topic
230
) –
Restricte
d
Cash
and ASU
No.
2016
-
15
(“ASU
2016
-
15”
),
Statement of Cash Flows (Topic
230
): Classification of Certain Cash Receipts and Cash Payments
. Accordingly, the condensed consolidated statement of cash flow for the
three
months ended
March 31, 2017
has been re-casted to conform with the current period presentation under this new guidance (refer to our condensed consolidated statements of cash flows included in this filing for a reconciliation of cash, cash equivalents and restricted cash).
 
Principles of Consolidation
 
The condensed consolidated financial statements include the accounts of Progenics as well as its wholly-owned subsidiaries. All material intercompany transactions and balances have been eliminated in consolidation.
 
Use of Estimates
 
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results
may
differ from those estimates.
 
Revenue Recognition
 
In
May 2014,
the FASB issued ASU
2014
-
09,
Revenue from Contracts with Customers (Topic
606
)
(“ASU
2014
-
09”
or the “Topic
606”
). The standard provides a single model for revenue arising from contracts with customers and supersedes current revenue recognition guidance. We adopted ASU
2014
-
09
on
January 1, 2018,
using the modified retrospective method, for all contracts
not
completed as of the date of adoption. The adoption of ASU
2014
-
09
represents a change in accounting principle that will more closely align revenue recognition with the transfer of promised goods or services to the customer. We implemented internal controls in
2017
to ensure we adequately evaluated our contracts and properly assessed the impact of the new accounting standard related to revenue recognition on our financial statements to facilitate adoption on
January 1, 2018.
There were
no
significant changes to our internal control over financial reporting due to the adoption of the new standard.
 
Based on the evaluation of our current contracts, revenue recognition is consistent under ASC
605
Revenue Recognition
and ASC
606
Revenue from Contracts with Customers
, except for revenue from variable consideration bonus payments under our software licensing arrangements. The cumulative effect of applying ASU
2014
-
09
to all contracts that were
not
completed as of
January 1, 2018
was recorded as a post-adoption adjustment of approximately
$35
thousand to the opening balance of accumulated deficit, with a corresponding increase to accounts receivable. Subsequent to the adoption of the new standard, variable consideration related to the bonus payments will be estimated and recognized when it is probable that a significant reversal of revenue will
not
occur.
 
Under this new guidance, we recognize revenue when our customers obtain control of the promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine whether arrangements are within the scope of this new guidance, we perform the following
five
steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy our performance obligations.
 
For contracts determined to be within the scope of Topic
606,
we assess the goods or services promised within each contract for the purpose of identifying them as performance obligations. We must apply judgement in assessing whether each promised good or service is distinct. If a promised good or service is
not
distinct, we will combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.  
 
The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices, which requires significant judgment. Variable consideration, which is estimated using the expected value method or the most likely amount method, is included in the transaction price only if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will
not
occur.
 
For arrangements that include development, regulatory or sales milestone payments, we evaluate whether the milestones are probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would
not
occur, the associated milestone value is included in the transaction price. Milestone payments that are
not
within our control or the licensee’s control, such as regulatory approvals, are generally
not
considered probable of being achieved until those approvals are received.
 
We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
 
We identified the following revenue streams from contracts with customers as part of our assessment: (
1
) royalties, (
2
) licensing and software licensing arrangements, and (
3
) other revenue. The following table summarizes revenue from contracts with customers for the
three
months ended
March 31, 2018:
 
Royalty income
  $
3,058
 
License revenue
   
130
 
Other revenue
   
1
 
Total revenue
 
$
3,189
 
 
Royalty income
- represents revenue from the sales-based royalties under our intellectual property licensing arrangements and is recognized upon net sales of the licensed products.
 
License revenue
- represents revenue from upfront payments (fixed consideration) and development and sales milestones, sublicense payments, support and service payments and sales-based bonus payments (variable consideration) under our licensing or software arrangements. The fixed consideration will be recognized as revenue at the time when the transfer of know-how is completed. The variable consideration will be estimated using the most likely amount method and recognized only when we have “a high degree of confidence” that revenue will
not
be reversed in a subsequent reporting periods.
 
Other revenue
– represents revenue from product sales of research reagents, and is recognized upon shipment to the end customer, which is when control of the product is deemed to be transferred.
 
We had customer contract balances of
$3.5
million and
$4.0
million as of
March 31, 2018
and
December 31, 2017,
respectively, primarily related to the royalty revenue stream (see
Note
5.
Accounts Receivable
).
 
Restricted Cash
 
Restricted cash included in current assets on our condensed consolidated balance sheets of
$2.4
million at
March 31, 2018,
represents funds restricted for the payment of interest and principal on the royalty-backed loan agreement (see
Note
9.
Non-Recourse Long-Term Debt, Net
for additional information), and the restricted cash included in long-term assets of
$1.5
million at
March 31, 2018
and
December 31, 2017,
represents collateral for letter of credit securing a lease obligation. We believe the carrying value of these assets approximates fair value.
 
Foreign Currency Translation
 
Our international subsidiaries generally consider their respective local currency to be their functional currency. Assets and liabilities of these international subsidiaries are translated into U.S. dollars at quarter-end exchange rates and revenues and expenses are translated at average exchange rates during the quarter and year-to-date period. Foreign currency translation adjustments for the reported periods are included in accumulated other comprehensive loss (“AOCL”) in our condensed consolidated statements of comprehensive loss, and the cumulative effect is included in the stockholders’ equity section of our condensed consolidated balance sheets. Realized gains and losses denominated in foreign currencies are recorded in operating expenses in our condensed consolidated statements of operations and were
not
material to our consolidated results of operations for the
three
months ended
March 31, 2018
or
2017.
 
Property and Equipment
 
Property and equipment is recorded at historical cost, net of accumulated depreciation and amortization of
$1.9
million and
$1.7
million as of
March 31, 2018
and
December 31, 2017,
respectively. The following table summarizes our property and equipment (in thousands):
 
   
March 31,
   
December 31,
 
   
2018
   
2017
 
Machinery and equipment
  $
2,516
    $
2,516
 
Leasehold improvements
   
1,734
     
1,734
 
Computer equipment
   
711
     
714
 
Furniture and fixtures
   
879
     
874
 
Construction in progress
   
13
     
-
 
Property and equipment, gross
   
5,853
     
5,838
 
Less - accumulated depreciation
   
(1,948
)    
(1,716
)
Property and equipment, net
 
$
3,905
   
$
4,122