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REVENUE RECOGNITION AND RELATED ALLOWANCES
9 Months Ended
Sep. 30, 2018
Revenue Recognition [Abstract]  
REVENUE RECOGNITION AND RELATED ALLOWANCES
2.
REVENUE RECOGNITION AND RELATED ALLOWANCES
 
Revenue Recognition
 
As of January 1, 2018, we adopted guidance for revenue recognition for contracts, using the modified retrospective method. The implementation of the guidance had no material impact on the measurement or recognition of revenue from customer contracts of prior periods. For our revenue recognition policies prior to adopting the guidance for revenue recognition for contracts, please see Item 8. Consolidated Financial Statements, Note 1, 
Description of Business and Summary of Significant Accounting Policies
, in our Annual Report on Form 10-K for the year ended December 31, 2017.
 
Upon adoption of this new guidance, we recognize revenue using the following steps:
 
·
Identification of the contract, or contracts, with a customer;
·
Identification of the performance obligations in the contract;
·
Determination of the transaction price, including the identification and estimation of variable consideration;
·
Allocation of the transaction price to the performance obligations in the contract; and
·
Recognition of revenue when we satisfy a performance obligation.
 
We derive our revenues primarily from sales of generic and branded pharmaceutical products. Revenue is recognized when our obligations under the terms of our contracts with customers are satisfied, which generally occurs when control of the products we sell is transferred to the customer. We estimate variable consideration after considering applicable information that is reasonably available. We generally do not have incremental costs to obtain contracts that would otherwise not have been incurred. We do not adjust revenue for the promised amount of consideration for the effects of a significant financing component because our customers generally pay us within 100 days.
 
All revenue recognized in the accompanying unaudited interim condensed consolidated statements of operations is considered to be revenue from contracts with customers.
The following table depicts the disaggregation of revenue according to contract type:
 
  
Three Months Ended
  
Nine Months Ended
 
(in thousands)
 
September 30,   
2018
  
September 30,  
2017
  
September 30,   
2018
  
September 30,   
2017
 
Sales of generic pharmaceutical products $30,287  $30,546  $83,716  $88,608 
Sales of branded pharmaceutical products  14,589   15,688   41,714   35,398 
Sales of contract manufactured products  2,826   1,829   5,450   5,151 
Royalties from licensing agreements  2,409   -   12,560   - 
Product development services
  288   -   288   - 
Other
(1)
  304   101   726   399 
Total net revenues $50,703  $48,164  $144,454  $129,556 
 
(1)
Primarily includes laboratory services and royalties on sales of contract manufactured products
 
The following table depicts revenue recognized during the following periods:
 
  
Three Months Ended
  
Nine Months Ended
 
(in thousands)
 
September 30,   
2018
  
September 30,  
2017
  
September 30,   
2018
  
September 30,   
2017
 
Performance obligations transferred at a point in time
 $50,415  $48,164  $144,166  $129,556 
Performance obligations transferred over time
  288   -   288   - 
Total $50,703  $48,164  $144,454  $129,556 
 
In the three and nine months ended September 30, 2018, we did not incur, and therefore did not defer, any material incremental costs to obtain contracts. We recognized $6.4 million of net revenue from performance obligations satisfied in prior periods during the nine months ended September 30, 2018, consisting primarily of royalties from licensing agreements and revised estimates for variable consideration, including chargebacks, rebates, returns, and other allowances, related to prior period sales. In August 2018, we acquired WellSpring (see Note 3), a contract manufacturing company that also provides technical transfer services to customers, for which services are transferred over time. As a result, we had $14 thousand of contract assets and $0.7 million of deferred revenue at September 30, 2018. We had no contract assets or deferred revenue at December 31, 2017 or June 30, 2018.
 
Revenue from Sales of Generic and Branded Pharmaceutical Products
 
Product sales consists of sales of our generic and brand pharmaceutical products. Our sole performance obligation in our contracts is to provide pharmaceutical products to customers. Our products are sold at pre-determined standalone selling prices and our performance obligation is considered to be satisfied when control of the product is transferred to the customer. Control is transferred to the customer upon delivery of the product to the customer, as our pharmaceutical products are sold on an FOB destination basis and because inventory risk and risk of ownership passes to the customer upon delivery. Payment terms for these sales are generally less than 100 days.
 
Sales of our pharmaceutical products are subject to variable consideration due to chargebacks, government rebates, returns, administrative and other rebates, and cash discounts. Estimates for these elements of variable consideration require significant judgment.
 
Chargebacks
 
Chargebacks, primarily from wholesalers, result from arrangements we have with indirect customers establishing prices for products which the indirect customer purchases through a wholesaler. Alternatively, we may pre-authorize wholesalers to offer specified contract pricing to other indirect customers. Under either arrangement, we provide a chargeback credit to the wholesaler for any difference between the contracted price with the indirect customer and the wholesaler's invoice price, typically Wholesale Acquisition Cost ("WAC").
 
Chargeback credits are calculated as follows:
 
Prior period chargebacks claimed by wholesalers are analyzed to determine the actual average selling price ("ASP") for each product. This calculation is performed by product by wholesaler. ASPs can be affected by several factors such as:
 
·
A change in customer mix
 
·
A change in negotiated terms with customers
 
·
A change in the volume of off-contract purchases
 
·
Changes in WAC
 
As necessary, we adjust ASPs based on anticipated changes in the factors above.
 
The difference between ASP and WAC is recorded as a reduction in both gross revenues in the consolidated statements of operations and accounts receivable in the consolidated balance sheets, at the time we recognize revenue from the product sale.
 
To evaluate the adequacy of our chargeback accruals, we obtain on-hand inventory counts from the wholesalers. This inventory is multiplied by the chargeback amount, the difference between ASP and WAC, to arrive at total expected future chargebacks, which is then compared to the chargeback accruals. We continually monitor chargeback activity and adjust ASPs when we believe that actual selling prices will differ from current ASPs.
 
Government Rebates
 
Our government rebates reserve consists of estimated payments due to governmental agencies for purchases made by third parties under various governmental programs. The two largest government programs that impact our net revenue and our government rebates reserve are federal and state Medicaid rebate programs and Medicare.
 
We participate in certain qualifying federal and state Medicaid rebate programs whereby discounts and rebates are provided to participating programs after the final dispensing of the product by a pharmacy to a Medicaid plan participant. Medicaid rebates are typically billed up to 120 days after the product is shipped. Medicaid rebate amounts per product unit are established by law, based on the Average Manufacturer Price (“AMP”), which is reported on a monthly and quarterly basis, and, in the case of branded products, best price, which is reported on a quarterly basis. Our Medicaid reserves are based on expected claims from state Medicaid programs. Estimates for expected claims are driven by patient usage, sales mix, calculated AMP or best price, as well as inventory in the distribution channel that will be subject to a Medicaid rebate. As a result of the delay between selling the products and rebate billing, our Medicaid rebate reserve includes both an estimate of outstanding claims for end-customer sales that have occurred but for which the related claim has not been billed, as well as an estimate for future claims that will be made when inventory in the distribution channel is sold through to plan participants.
 
Many of our products are also covered under Medicare. We, like all pharmaceutical companies, must provide a discount for any products sold under New Drug Applications (“NDAs”) to Medicare Part D participants. This applies to all products sold under NDAs, regardless of whether the products are marketed as branded or generic. Our estimates for these discounts are based on historical experience with Medicare rebates for our products. While such experience has allowed for reasonable estimations in the past, history may not always be an accurate indicator of future rebates. Medicare rebates are typically billed up to 120 days after the product is shipped. As a result of the delay between selling the products and rebate billing, our Medicare rebate reserve includes both an estimate of outstanding claims for end-customer sales that have occurred but for which the related claim has not been billed, as well as an estimate for future claims that will be made when inventory in the distribution channel is sold through to Medicare Part D participants.
 
To evaluate the adequacy of our government rebate reserves, we review the reserves on a quarterly basis against actual claims data to ensure the liability is fairly stated. We continually monitor our government rebate reserve and adjust our estimates if we believe that actual government rebates may differ from our established accruals. Accruals for government rebates are recorded as a reduction to gross revenues in the consolidated statements of operations and as an increase to accrued government rebates in the consolidated balance sheets.
 
Returns
 
We maintain a return policy that allows customers to return product within a specified period prior to and subsequent to the expiration date. Generally, product may be returned for a period beginning six months prior to its expiration date to up to one year after its expiration date. Our product returns are settled through the issuance of a credit to the customer. Our estimate for returns is based upon historical experience with actual returns. While such experience has allowed for reasonable estimation in the past, history may not always be an accurate indicator of future returns. We continually monitor our estimates for returns and make adjustments when we believe that actual product returns may differ from the established accruals. Accruals for returns are recorded as a reduction to gross revenues in the consolidated statements of operations and as an increase to the return goods reserve in the consolidated balance sheets.
 
Administrative Fees and Other Rebates
 
Administrative fees or rebates are offered to wholesalers, group purchasing organizations and indirect customers. We accrue for fees and rebates, by product by wholesaler, at the time of sale based on contracted rates and ASPs.
 
To evaluate the adequacy of our administrative fee accruals, we obtain on-hand inventory counts from the wholesalers. This inventory is multiplied by the ASPs to arrive at total expected future sales, which is then multiplied by contracted rates. The result is then compared to the administrative fee accruals. We continually monitor administrative fee activity and adjust our accruals when we believe that actual administrative fees will differ from the accruals. Accruals for administrative fees and other rebates are recorded as a reduction in both gross revenues in the consolidated statements of operations and accounts receivable in the consolidated balance sheets.
 
Prompt Payment Discounts
 
We often grant sales discounts for prompt payment. The reserve for prompt payment discounts is based on invoices outstanding. We assume, based on past experience, that all available discounts will be taken. Accruals for prompt payment discounts are recorded as a reduction in both gross revenues in the consolidated statements of operations and accounts receivable in the consolidated balance sheets.
 
The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the nine months ended September 30, 2018 and 2017, respectively:
 
(in thousands)
 
Accruals for Chargebacks, Rebates, Returns, and Other Allowances
 
           
Administrative
  
Prompt
 
     
Government
     
Fees and Other
  
Payment
 
  
Chargebacks
  
Rebates
  
Returns
  
Rebates
  
Discounts
 
Balance at December 31, 2016 $26,785  $5,891  $5,756  $3,550  $1,554 
Accruals/Adjustments  133,849   7,807   8,949   16,840   5,960 
Credits Taken Against Reserve  (134,412)  (7,943)  (6,388)  (15,448)  (5,617)
Balance at September 30, 2017 $26,222  $5,755  $8,317  $4,942  $1,897 
                     
Balance at December 31, 2017 $28,230  $7,930  $8,274  $5,226  $1,834 
Accruals/Adjustments  170,533   8,097   10,942   23,148   6,744 
Credits Taken Against Reserve  (156,750)  (7,013)  (8,376)  (21,418)  (6,373)
Balance at September 30, 2018 $42,013  $9,014  $10,840  $6,956  $2,205 
 
Contract Manufacturing Product Sales Revenue
 
Contract manufacturing arrangements consists of agreements in which we manufacture a pharmaceutical product on behalf of third party. Our performance obligation is to manufacture and provide pharmaceutical products to customers, typically pharmaceutical companies. The contract manufactured products are sold at pre-determined standalone selling prices and our performance obligations are considered to be satisfied when control of the product is transferred to the customer. Control is transferred to the customer when the product leaves our dock to be shipped to the customer, as our pharmaceutical products are sold on an FOB shipping point basis and the inventory risk and risk of ownership passes to the customer at that time. Payment terms for these sales are generally less than two months. We estimate returns based on historical experience. Historically, we have not had material returns for contract manufactured products.
 
As of September 30, 2018, the value of our unsatisfied performance obligations (or backlog) was $5.7 million, which consists of firm orders for contract manufactured products, for which our performance obligations remain unsatisfied and for which the related revenue has yet to be recognized. We anticipate satisfying these performance obligations within six months.
 
Royalties from Licensing Agreements
 
From time to time, we enter into transition agreements with the sellers of products we acquire, under which we license to the seller the right to sell the acquired products. Therefore, we recognize the revenue associated with sales of the underlying products as royalties. Because these royalties are sales-based, we recognize the revenue when the underlying sales occur, based on sales and gross profit information received from the sellers. Upon full transition of the products and upon launching the products under our own labels, we recognize revenue for the products as sales of generic or branded pharmaceutical products, as described above.
 
In addition, we receive royalties from a license for patent rights initially owned by Cell Genesys, Inc., which merged with BioSante in 2009. The royalties are the results of sales and milestones related to the Yescarta® product. We recognize revenue for sales-based royalties when the underlying sales occur. We estimate variable consideration related to milestones, which requires significant judgment.
 
Product Development
 
Services Revenue
 
We provide product development services to customers, which are performed over time. These services primarily relate to the technical transfer of products to our facility in Oakville, Canada. The duration of these technical transfer projects is generally 18 months to three years. Deposits received from these customers are recorded as deferred revenue until revenue is recognized. For contracts with no deposits and for the remainder of contracts with deposits, we invoice customers as our performance obligations are satisfied. We recognize revenue on a percentage of completion basis, which results in contract assets on our balance sheet. As of September 30, 2018, the value of our unsatisfied performance obligations for product development services contracts was $3.5 million. We expect to satisfy these performance obligations in the next 9 to 15 months.
 
Credit Concentration
 
Our customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and pharmaceutical companies.
 
During the three months ended
September 30, 2018
, three customers represented
35
%,
23
%, and
20
% of net revenues, respectively. During the nine months ended
September 30, 2018
, the same three customers represented
34
%,
23
%, and
20
% of net revenues respectively. As of
September 30, 2018
, accounts receivable from these customers totaled
80
% of accounts receivable, net. During the three months ended
September 30, 2017
, three customers represented
30
%,
30
%, and
19
% of net revenues, respectively. During the nine months ended
September 30, 2017
, these same three customers represented
31
%,
26
%, and
21
% of net revenues, respectively.