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Note 14 - License, Collaboration and Distribution Agreements
12 Months Ended
Dec. 31, 2019
Notes to Financial Statements  
License, Collaboration, and Distribution Agreements [Text Block]
NOTE
14.
LICENSE, COLLABORATION AND DISTRIBUTION AGREEMENTS
 
Transactions under the Company's major distribution agreements are recognized upon transfer of control to its major distribution partners at the amount of consideration that the Company expects to be entitled to. The Company records contract liabilities for the invoiced amounts that are estimated to be subject to significant reversal, including product revenue allowances for cash consideration paid to customers for services, discounts, rebate programs, chargebacks, and product returns.
 
Milestone payments are included in the estimated transaction price when they are considered probable of being achieved. For license and collaboration revenue, the transaction price under license and collaboration arrangements, including upfront fees and milestone payments, are allocated differently to each performance obligation and
may
be recognized at earlier points in time or with a different pattern of performance over time. 
 
The following table presents changes in the Company's contract assets and liabilities 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 liabilities: deferred revenue
  $
41
    $
-
    $
(41
)   $
-
 
Contract liabilities: accrued liabilities
   
1,432
     
5,708
     
(6,706
)    
434
 
Total
  $
1,473
    $
5,708
    $
(6,747
)   $
434
 
 
For the years ended
December 31, 2019
and
2018,
the Company recognized the following revenue (in thousands):
 
   
Year Ended December 31,
 
   
2019
   
2018
 
Revenue recognized in the period from:
               
Amounts included in contract liabilities at the beginning of the year:
               
Performance obligations satisfied
  $
1,473
    $
1,453
 
New activities during the year:
               
Performance obligations satisfied
   
5,126
     
11,055
 
                 
    $
6,599
    $
12,508
 
 
License, Collaboration and Distribution Agreements
 
In
January 2012,
the Company entered into a distribution agreement with China Pioneer Pharma Holdings Limited, a Shanghai-based company (“China Pioneer”) that markets high-end pharmaceutical products into China and an affiliate of Pioneer Singapore, for the commercialization of NeutroPhase in this territory. Under the terms of the agreement, NovaBay received an upfront payment of
$312,500.
NovaBay also received
$312,500
in
January 2013,
related to the submission of the
first
marketing approval for the product to the Chinese Food and Drug Administration (the “CFDA”). The deferred revenue was recognized as the purchase discounts were earned, with the remaining deferred revenue recognized ratably over the product distribution period. During the year ended
December 31, 2014,
NovaBay received
$625,000
upon receipt of a marketing approval of the product from the CFDA.
 
In
September 2012,
the Company entered into
two
agreements with China Pioneer: (
1
) an international distribution agreement (“Distribution Agreement”) and (
2
) a unit purchase agreement (“Purchase Agreement”). These agreements were combined and accounted for as
one
arrangement with
one
unit of accounting for revenue recognition purposes.
 
Pursuant to the terms of the Distribution Agreement, China Pioneer has the right to distribute NeutroPhase, upon a marketing approval from a Regulatory Authority, in certain territories in Asia (other than China). Upon execution of the Distribution Agreement, the Company received an upfront payment, which was recorded as deferred revenue. China Pioneer is also obligated to make certain additional payments to the Company upon receipt of the marketing approval. The Distribution Agreement further provides that China Pioneer is entitled to a cumulative purchase discount
not
to exceed
$500,000
upon the purchase of NeutroPhase product, payable in NovaBay unregistered restricted common stock.
 
Pursuant to the Purchase Agreement, the Company also received
$2.5
million from China Pioneer for the purchase of restricted units (comprising
one
share of common stock and a warrant for the purchase of
one
share of common stock). The unit purchase was completed in
two
tranches: (
1
)
800,000
units in
September 2012;
and (
2
)
1,200,000
units in
October 2012,
with both tranches at a purchase price of
$1.25
per unit. The fair value of the total units sold was
$3.5
million, based upon the trading price of the Company’s common stock on the dates the units were purchased and the fair value of the warrants based on the Black-Scholes Merton option pricing model. Because the aggregate fair value of the units on the dates of purchase exceeded the
$2.5
million in proceeds received from the unit purchase by approximately
$1.0
million, the Company reallocated
$600,000
from deferred revenue to stockholders’ equity as consideration for the purchase of the units.
 
In
December 2013,
the Company announced it had expanded its NeutroPhase commercial partnership agreement with China Pioneer. The expanded agreement includes licensing rights to Avenova and CelleRx, which were developed internally by NovaBay. The expanded partnership agreement covers the commercialization and distribution of these products in China and
11
countries in Southeast Asia.
 
On
February 7, 2012,
the Company entered into a distribution agreement with Integrated Healing Technologies, LLC, (“IHT”) to distribute NeutroPhase. NovaBay received an upfront payment of
$750,000.
 
In
April 2013,
the Company entered into a collaboration and license agreement with Virbac. Under this agreement, Virbac acquired exclusive worldwide rights to develop the Company’s proprietary compound, auriclosene (NVC-
422
), for global veterinary markets for companion animals. The Company received an upfront payment of
$250,000.
 
On
June 1, 2013,
the Company entered into a distribution agreement with Principal Business Enterprise Inc. (“PBE”) to distribute NeutroPhase. NovaBay received an upfront payment of
$200,000.
 
Revenue has been recognized under these agreements as follows: 
 
   
Year Ended
 
   
December 31,
 
(in thousands)
 
2019
   
2018
   
2017
 
Amortization of upfront technology and access fees
  $
41
    $
34
    $
103
 
Product revenue
   
209
     
169
     
1,956
 
Total revenue recognized
  $
250
    $
203
    $
2,059
 
 
At
December 31, 2018,
the Company had deferred revenue of
$41
thousand that relates to unsatisfied performance obligations of sample supply due to China Pioneer and an incremental discount on future product sales due to Pioneer China. During the year ended
December 31, 2019,
the Company earned
$41
thousand in revenue due to the Company being relieved of contract liability as a result of changes in contract terms associated with the distribution agreement with China Pioneer. The Company did
not
have any deferred revenue at
December 31, 2019.
 
Avenova Distribution Agreements and Specialty Pharmacies
 
In
November 2014,
the Company signed a nationwide distribution agreement for its Avenova product with McKesson Corporation (“McKesson”) as part of the Company’s commercialization strategy. McKesson makes Avenova widely available in local pharmacies and major retail chains across the U.S., such as Wal-Mart, Costco, CVS and Target. In
January 2015,
the Company signed a nationwide distribution agreement with Cardinal Health. In
April 2015,
the Company also signed a distribution agreement with AmerisourceBergen to distribute Avenova nationwide. 
 
Since the start of
2019
the number of pharmacies in our Partner Pharmacy Program has increased from
4
to
14,
placing us on track to increase Avenova sales through retail pharmacies from
one
-quarter to
one
-half of all sales. Our partner pharmacies provide patients with a quality experience that includes a relatively short time between receiving the initial prescription and filling it, fast refills and home delivery. The combination of a pre-negotiated price along with a reduction in coupon and rebate usage improves our gross-to-net and per-script profitability. During the years ended
December 31, 2019,
2018
and
2017,
the revenue generated from these pharmacies comprised
21%,
1%
and
0%
of our total product revenue, respectively.
 
During the years ended
December 31, 2019,
2018
and
2017,
the Company earned
$4.6
million,
$11.0
million and
$13.6
million,
 
respectively, in sales revenue for its Avenova product from its distribution agreements and specialty pharmacies.
 
Under the Avenova product distribution arrangements, the Company had a contract liability balance of
$0.4
million and
$1.4
million at
December 31, 2019
and
December 31, 2018,
respectively. The contract liability is included in accrued liabilities in the consolidated balance sheet. The contract liability as of
December 31, 2019
and
December 31, 2018
included a prepayment of
$0.4
million and
$0.9
million rebate, respectively, that is recorded in the prepaid expenses and other current assets in the consolidated balance sheet (see Note
4,
“Prepaid Expenses and Other Current Assets”).  
 
Avenova Direct 
 
In an effort to improve patient access, Avenova Direct was launched on
June 1, 2019
to U.S. customers exclusively on Amazon.com. Avenova Direct is the same strength hypochlorous formulation as Avenova Rx, but comes in a
20mL
size. This channel offers the Company with stable gross-to-net pricing and provides customers with easy access to our product. This model capitalizes on a trend to sell pharmaceutical products directly to consumers in response to high-deductible health plans, allowing customers to forego a time-consuming doctor visit and trip to the pharmacy. We are promoting this program through complementary social media marketing to target consumers in specific demographics, as well as to ophthalmologists, optometrists, and current and former Avenova patients. During the year ended
December 31, 2019,
the revenue generated from Avenova Direct was
$1.0
million.