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Note 5 - Revenue from Contracts with Customers
12 Months Ended
Dec. 31, 2019
Notes to Financial Statements  
Revenue from Contract with Customer [Text Block]
5
.
Revenue from Contracts with Customers
 
The following table summarizes revenue from contracts with customers for the years ended
December 31, 2019,
2018
and
2017
into categories that depict how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors (in thousands):
 
   
December 31,
 
   
201
9
   
201
8
   
201
7
 
Product sales:
                       
DSUVIA
  $
377
    $
    $
 
Zalviso
   
1,453
     
825
     
6,673
 
Total product sales
   
1,830
     
825
     
6,673
 
Contract and other collaboration:
                       
DoD Contract revenue
   
     
838
     
852
 
Non-cash royalty revenue related to Royalty Monetization (See Note 8)
   
312
     
289
     
151
 
Royalty revenue
   
104
     
96
     
50
 
Other revenue
   
43
     
103
     
269
 
Total revenues from contract and other collaboration
   
459
     
1,326
     
1,322
 
Total revenue
  $
2,289
    $
2,151
    $
7,995
 
 
For additional detail on the Company’s accounting policy regarding revenue recognition, refer to Note
1
“Organization and Summary of Significant Accounting Policies - Revenue from Contracts with Customers.”
 
Product Sales
 
The Company’s commercial launch of DSUVIA in the United States occurred in the
first
quarter of
2019.
Zalviso is sold in Europe by the Company’s collaboration partner, Grünenthal.
 
Contract and Other Collaboration
 
Amended License Agreement
 
Under the Amended License Agreement with Grünenthal, the Company is eligible to receive approximately
$194.5
million in additional milestone payments, based upon successful regulatory and product development efforts (
$28.5
million) and net sales target achievements (
$166.0
million). Grünenthal will also make tiered royalty and supply and trademark fee payments in the mid-teens up to the mid-twenties percent range, depending on the level of sales achieved, on net sales of Zalviso. A portion of the tiered royalty payment, exclusive of the supply and trademark fee payments, will be paid to PDL in connection with the Royalty Monetization. For additional information on the Royalty Monetization with PDL, see Note
8
“Liability Related to Sale of Future Royalties”. Unless earlier terminated, the Amended License Agreement continues in effect until the expiration of the obligation of Grünenthal to make royalty and supply and trademark fee payments, which supply and trademark fee continues for so long as the Company continues to supply the Product to Grünenthal. The Amended License Agreement is subject to earlier termination in the event the parties mutually agree, by a party in the event of an uncured material breach by the other party, upon the bankruptcy or insolvency of either party, or by Grünenthal for convenience.
 
Amended MSA
 
Under the terms of the Amended MSA with Grünenthal, the Company will manufacture and supply the Product for use in the Field for the Territory exclusively for Grünenthal. The Product will be supplied at prices approximating the Company’s manufacturing cost, subject to certain caps, as defined in the MSA Amendment. The MSA Amendment requires the Company to use commercially reasonable efforts to enter stand-by contracts with
third
parties providing significant supply and manufacturing services and, under certain specified conditions, permits Grünenthal to use a
third
-party back-up manufacturer to manufacture the Product for Grünenthal’s commercial sale in the Territory.
 
The Amended Agreements entitle the Company to receive additional payments upon the achievement of certain development milestones which relate to post approval product enhancements, expanded market opportunities and manufacturing efficiencies for Zalviso and require future research, development and regulatory activities. These payments are excluded from the transaction price as they are considered payments for optional additional services that Grünenthal
may
elect in the future. When these services are elected, they will be considered as a new contract under ASC Topic
606
and will
not
impact the revenue recognition of the performance obligations identified under Amended Agreements.
 
The Amended Agreements also include milestone payments related to specified net sales targets, totaling
$166.0
million. These payments are considered sales-based license royalties under ASC Topic
606
and will be recognized apart from the other contract consideration when the related sales occur.
 
The Company recognizes revenue from license rights when the customer can use and benefit from the license rights. The Company recognizes revenue from its services performance obligations over time using a cost-to-cost input method which best represents the incremental benefit that the customer receives as control is transferred.
 
DoD Contract
 
On
May 11, 2015,
the Company entered into an award contract (referred to as the DoD Contract) supported by the Clinical and Rehabilitative Medicine Research Program, or CRMRP, of the United States Army Medical Research and Materiel Command, or the USAMRMC, within the U.S. Department of Defense, or the DoD, in which the DoD agreed to provide up to
$17.0
million to the Company in order to support the development of DSUVIA. The DoD contract period of performance ended on
February 28, 2019.
 
Contract Liability
 
The Company has entered into the Amended Agreements with Grünenthal related to Zalviso. At
December 31, 2019,
approximately
$3.1
million of deferred revenue,
$0.3
million of which represented the current portion, was attributable to the significant and incremental discount on Zalviso manufacturing services for Grünenthal. This deferred revenue is being recognized on a straight-line basis over the period such discount is made available to Grünenthal, which is estimated to continue through
2029.
 
The following table presents changes in the Company’s contract liability for the year ended
December 31, 2019:
 
   
Balance at
Beginning
of the Period
   
Additions
   
Deductions
   
Balance at
the end
of the Period
 
   
(in thousands)
 
Contract liability:
                               
Deferred revenue – Amended Agreements
  $
3,463
    $
    $
(315
)   $
3,148
 
Deferred revenue – Other
   
     
96
     
     
96
 
Deferred revenue
  $
3,463
    $
96
    $
(315
)   $
3,244
 
 
For the years ended
December 
31,
2019
and
2018,
the Company recognized the following revenue from performance obligations satisfied (in thousands):
 
   
Year ended
December 31, 2019
   
Year ended December 31, 2018
 
Amounts included in contract liabilities at the beginning of the period:
               
Performance obligations satisfied – Amended Agreements
  $
315
    $
362
 
New activities in the period from performance obligations satisfied:
               
Performance obligations satisfied – Amended Agreements
   
1,181
     
566
 
Total revenue from performance obligations satisfied
  $
1,496
    $
928