The Company’s performance obligation is the supply of finished pharmaceutical and related products to its customers. The Company’s customers consist primarily of major wholesalers, retail pharmacies, managed care organizations, purchasing co-ops, hospitals, government agencies, institutions, and pharmaceutical companies. The Company’s customer contracts generally consist of both a master agreement, which is signed by the Company and its customer, and/or a customer submitted purchase order, which is governed by the terms and conditions of the master agreement. Customers purchase product by direct channel sales from the Company or by indirect channel sales through various distribution channels.
Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, either upon shipment or delivery. Substantially all of the Company’s net revenues relate to products which are transferred to the customer at a point-in-time.
The Company offers standard payment terms to its customers and has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing, since the period between when the Company transfers the product to the customer and when the customer pays for that product is one year or less. Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from revenues. The consideration amounts due from customers as a result of product sales are subject to variable consideration, as described further below.
The Company offers standard product warranties which provide assurance that the product will function as expected and in accordance with specifications. Customers cannot purchase warranties separately and these warranties do not give rise to a separate performance obligation.
The Company permits the return of product under certain circumstances, mainly upon product expiration, instances of shipping errors or where product is damaged in transit. The Company accrues for the customer’s right to return as part of its variable consideration. See below for further details.
The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. Variable consideration includes but is not limited to: chargebacks, distribution fees, rebates, group purchasing organization ("GPO") fees, prompt payment (cash) discounts, consideration payable to the customer, billbacks, Medicaid and other government pricing programs, price protection and shelf stock adjustments, sales returns, and profit shares.
The Company assesses whether or not an estimate of its variable consideration is constrained and has determined that the constraint does not apply, since it is probable that a significant reversal in the amount of cumulative revenue will not occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive.
In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is lower than the wholesaler pricing, the Company pays the direct customer (wholesaler) a chargeback for the price differential. The Company estimates its chargeback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to chargebacks and historical chargeback rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers.
The Company pays fixed or volume-based rebates to its customers based on a fixed amount, fixed percentage of product sales or based on the achievement of a specified level of purchases. The Company’s rebate accruals are based on actual net sales, contractual rebate rates negotiated with customers, and expected purchase volumes / corresponding tiers based on actual sales to date and forecasted amounts.
Group Purchasing Organization Fees
The Company pays fees to GPOs for administrative services that the GPOs perform in connection with the purchases of product by the GPO participants who are the Company’s customers. The Company’s GPO fee accruals are based on actual net sales, contractual fee rates negotiated with GPOs and the mix of the products in the distribution channel that remain subject to GPO fees.
Prompt Payment (Cash) Discounts
The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount accruals are based on actual net sales and contractual discount rates.
Consideration Payable to the Customer
The Company pays administrative and service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company accrues for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees.
In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is higher than contractual pricing, the Company pays the indirect customer a billback for the price differential. The Company estimates its billback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to billbacks and historical billback rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers.
Medicaid and Other Government Pricing Programs
The Company complies with required rebates mandated by law under Medicaid and other government pricing programs. The Company estimates its government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rates and estimated lag time of the rebate invoices.
Price Protection and Shelf Stock Adjustments
The Company provides customers with price protection and shelf stock adjustments which may result in an adjustment to the price charged for the product transferred, based on differences between old and new prices which may be applied to the customer’s on-hand inventory at the time of the price change. The Company accrues for these adjustments when its expected value of an adjustment is greater than zero, based on contractual pricing, actual net sales, accrual rates based on historical average rates, and estimates of the level of inventory of its products in the distribution channel that remain subject to these adjustments. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers.
The Company permits the return of product under certain circumstances, mainly upon product expiration, instances of shipping errors or where product is damaged in transit, and occurrences of product recalls. The Company’s product returns accrual is primarily based on estimates of future product returns based generally on actual net sales, estimates of the level of inventory of its products in the distribution channel that remain subject to returns, estimated lag time of returns and historical return rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers.
For certain product sale arrangements, the Company earns a profit share upon the customer’s sell-through of the product purchased from the Company. The Company estimates its profit shares based on actual net sales, estimates of the level of inventory of its products in the distribution channel that remain subject to profit shares, and historical rates of profit shares earned. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers.
Concentration of Revenue
The Company's three largest customers accounted for approximately 84% and 83% of total gross sales of products for the three and six months ended June 30, 2020, respectively. The Company's three largest customers accounted for approximately 81% and 80% of total gross sales of products for the three and six months ended June 30, 2019, respectively.
The Company's significant therapeutic classes for its Generics and Specialty segments and sales channels for its AvKARE segment, as determined based on net revenue for each of the three and six months ended June 30, 2020 and 2019 are set forth below (in thousands):
|Three Months Ended June 30,||Six Months Ended June 30,|
|Anti-Infective||$||9,722 || ||$||8,147 || ||$||22,776 || ||$||14,089 || |
|Hormonal/Allergy||89,277 || ||92,293 || ||177,919 || ||195,018 || |
|Antiviral||955 || ||1,346 || ||16,779 || ||15,802 || |
Central Nervous System (1)
|96,228 || ||117,398 || ||195,810 || ||242,173 || |
|Cardiovascular System||25,105 || ||31,138 || ||54,359 || ||67,355 || |
|Gastroenterology||16,625 || ||9,938 || ||37,878 || ||19,494 || |
|Oncology||16,567 || ||21,746 || ||31,422 || ||36,705 || |
|Metabolic Disease/Endocrine||6,769 || ||10,887 || ||23,408 || ||28,734 || |
|Respiratory||7,240 || ||8,418 || ||17,328 || ||17,636 || |
|Dermatology||10,442 || ||14,771 || ||27,584 || ||27,744 || |
|Other therapeutic classes||26,668 || ||15,263 || ||51,935 || ||33,440 || |
|International and other||961 || ||3,719 || ||1,947 || ||19,351 || |
|Total Generics net revenue||306,559 || ||335,064 || ||659,145 || ||717,541 || |
|Hormonal/Allergy||13,669 || ||9,888 || ||27,623 || ||20,787 || |
Central Nervous System (1)
|74,056 || ||50,694 || ||142,367 || ||93,593 || |
|Gastroenterology||439 || ||452 || ||487 || ||933 || |
|Metabolic Disease/Endocrine||203 || ||89 || ||476 || ||630 || |
|Other therapeutic classes||5,889 || ||8,455 || ||11,280 || ||17,278 || |
|Total Specialty net revenue||94,256 || ||69,578 || ||182,233 || ||133,221 || |
|Distribution||31,839 || ||— || ||63,425 || ||— || |
|Government Label||25,073 || ||— || ||46,451 || ||— || |
|Institutional||4,511 || ||— || ||7,924 || ||— || |
|Other||2,424 || ||— || ||4,017 || ||— || |
|Total AvKARE net revenue||63,847 || ||— || ||121,817 || ||— || |
|Total net revenue||$||464,662 || ||$||404,642 || ||$||963,195 || ||$||850,762 || |
(1)During the three months ended September 30, 2019, operating results for Oxymorphone were reclassified from Generics to Specialty, where it is sold as a non-promoted product. Prior period results have not been restated to reflect the reclassification.
A rollforward of the major categories of sales-related deductions for the six months ended June 30, 2020 is as follows (in thousands):
Charge - Backs
|Balance at December 31, 2019||$||829,807 || ||$||34,308 || ||$||150,361 || ||$||114,960 || |
|Impact from the Acquisitions||12,444 || ||944 || ||15,229 || ||10 || |
|Provision related to sales recorded in the period||2,025,733 || ||60,000 || ||49,285 || ||69,685 || |
|Credits/payments issued during the period||(2,197,368)|| ||(71,093)|| ||(52,202)|| ||(63,062)|| |
|Balance at June 30, 2020||$||670,616 || ||$||24,159 || ||$||162,673 || ||$||121,593 || |