XML 26 R10.htm IDEA: XBRL DOCUMENT v3.22.2
REVENUE RECOGNITION AND RELATED ALLOWANCES
6 Months Ended
Jun. 30, 2022
REVENUE RECOGNITION AND RELATED ALLOWANCES  
REVENUE RECOGNITION AND RELATED ALLOWANCES

2.

REVENUE RECOGNITION AND RELATED ALLOWANCES

Revenue Recognition

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:

Three Months Ended

Six Months Ended

Products and Services

June 30, 

June 30, 

June 30, 

June 30, 

(in thousands)

    

2022

    

2021

    

2022

    

2021

    

Sales of generic pharmaceutical products

$

49,863

$

34,199

$

98,970

$

66,812

Sales of established brand pharmaceutical products

 

8,463

 

11,038

 

16,915

 

18,555

Sales of rare disease pharmaceutical products

10,202

11,494

Sales of contract manufactured products

 

4,389

 

2,322

 

7,293

 

4,895

Royalties from licensing agreements

 

194

 

 

2,097

 

11,210

Product development services

 

531

 

97

 

1,097

 

255

Other

 

213

 

969

 

466

 

1,419

Total net revenues

$

73,855

$

48,625

$

138,332

$

103,146

Three Months Ended

Six Months Ended

Timing of Revenue Recognition

June 30, 

June 30, 

June 30, 

June 30, 

(in thousands)

    

2022

    

2021

    

2022

    

2021

    

Performance obligations transferred at a point in time

$

73,324

$

48,528

$

137,235

$

102,891

Performance obligations transferred over time

 

531

 

97

 

1,097

 

255

Total

$

73,855

$

48,625

$

138,332

$

103,146

In the three and six months ended June 30, 2022 and 2021, we did not incur, and therefore did not defer, any material incremental costs to obtain or fulfill contracts. We recognized a decrease of $3.7 million to net revenue from performance obligations satisfied in prior periods during the six months ended June 30, 2022, consisting primarily of revised estimates for variable consideration, including chargebacks, rebates, returns, and other allowances, related to prior period sales. We recognized an increase of $10.3 million to net revenue from performance obligations satisfied in prior periods during the six months ended June 30, 2021, consisting primarily of a final royalty revenue related to

the Kite license agreement pursuant to the Tripartite Agreement as described herein in Royalties from Licensing Agreements. We provide technical transfer services to customers, for which services are transferred over time. As of June 30, 2022 and December 31, 2021, we did not have any contract assets related to revenue recognized based on percentage of completion but not yet billed. Our deferred revenue balance as of June 30, 2022, December 31, 2021, and December 31, 2020 was immaterial. For the three and six months ended June 30, 2022, we recognized $0.1 million of revenue that was included in deferred revenue as of December 31, 2021. For the three and six months ended June 30, 2021, we recognized less than $0.1 million of revenue that was included in deferred revenue as of December 31, 2020. Deferred revenue is included in accrued expenses and other in the unaudited interim condensed consolidated balance sheets.

Revenue from Sales of Generic and Branded Pharmaceutical Products

Product sales consists of sales of our generic and branded pharmaceutical products, including rare disease 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 generally transferred to the customer upon delivery of the product to the customer, as our pharmaceutical products are generally 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.

The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the six months ended June 30, 2022 and 2021, respectively:

Accruals for Chargebacks, Returns, and Other Allowances

Administrative

Prompt

Government

Fees and Other

Payment

(in thousands)

    

Chargebacks

    

Rebates

    

Returns

    

Rebates

    

Discounts

Balance at December 31, 2020 (1)

$

88,746

$

7,826

$

27,155

$

8,906

$

3,839

Accruals/Adjustments

 

214,125

 

12,980

 

21,058

 

32,207

 

13,315

Credits Taken Against Reserve

 

(220,776)

(12,066)

 

(16,309)

 

(33,071)

 

(13,682)

Balance at June 30, 2021 (1)

$

82,095

$

8,740

$

31,904

$

8,042

$

3,472

Balance at December 31, 2021 (1)

$

94,066

$

5,492

$

35,831

$

13,100

$

4,642

Accruals/Adjustments

 

320,191

 

9,356

 

15,057

 

20,701

 

10,494

Credits Taken Against Reserve

 

(274,714)

(5,408)

 

(15,989)

 

(19,283)

 

(8,938)

Balance at June 30, 2022 (1)

$

139,543

$

9,440

$

34,899

$

14,518

$

6,198

(1)Chargebacks are included as an offset to accounts receivable in the unaudited interim condensed consolidated balance sheets. Administrative Fees and Other Rebates and Prompt Payment Discounts are included as an offset to accounts receivable or as accrued expenses and other in the unaudited interim condensed consolidated balance sheets. Returns are included in returned goods reserve in the unaudited interim condensed consolidated balance sheets. Government Rebates are included in accrued government rebates in the unaudited interim condensed consolidated balance sheets.

Contract Manufacturing Product Sales Revenue

Contract manufacturing arrangements consist of agreements in which we manufacture a pharmaceutical product on behalf of a 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 contract manufactured 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 fewer than two months. We estimate returns based on historical experience. Historically, we have not had material returns for contract manufactured products.

As of June 30, 2022, the aggregate amount of the transaction price allocated to the remaining performance obligations for all open contract manufacturing customer contracts was $7.2 million, which consists of firm orders for contract manufactured products. We will recognize revenue for these performance obligations as they are satisfied, which is anticipated 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. From time to time, we enter into supply and distribution agreements with contract manufacturing customers, under which we license to the contract manufacturing customer the right to sell our products, and we are entitled to a royalty on sales made by the contract manufacturing customer under these arrangements. 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 contract manufacturing customers.

Pursuant to a 2012 Tripartite Agreement (the “Tripartite Agreement”) between the Company, The Regents of the University of California (“The Regents”), and Cabaret Biotech Ltd., an Israeli corporation (“Cabaret”) (as assignee of Dr. Zelig Eshhar’s rights under the Tripartite Agreement), and subsequent amendments thereto and assignments thereof, we were entitled to receive a percentage of the milestone and sales royalty payments paid to Cabaret by Kite Pharma, Inc. (“Kite”), a subsidiary of Gilead Sciences, Inc., under a license agreement. Under such license agreement, Kite licensed from Dr. Eshhar and Cabaret the patent rights covered by the Tripartite Agreement and agreed to make certain payments to Cabaret based on, among other things, Kite’s sales of Yescarta®. Under the Tripartite Agreement, portions of these payments were to be distributed to The Regents and to us.

Historically, we recorded royalty income related to Yescarta® on an accrual basis utilizing our best estimate of royalties earned based upon information available in the public domain, our understanding of the various agreements governing the royalty, and other information received from time to time from the relevant parties. Generally, cash was received directly from Cabaret once a year. The agreements governing this royalty were subject to multiple actions in multiple jurisdictions, including litigation between Cabaret and Kite, and separately, ANI and Cabaret. In the first quarter of 2021, we became aware that the litigation between Cabaret and Kite was dismissed. In April 2021, Cabaret and the Company settled all amounts due for amounts actually received by Cabaret or Eshhar for the licensing or use of the patent rights governed by the Kite license agreement. As a result, we recognized $11.2 million as royalties from licensing agreements in our net revenues during the three month period ended March 31, 2021. In addition, during the three month period ended March 31, 2021, we agreed to reimburse Cabaret $0.4 million, which has been recorded as other expense, net in the accompanying unaudited interim condensed consolidated statement of operations, related to certain legal expenditures incurred. We received final payment from Cabaret in May 2021. Based upon the events that led to the dismissal of the litigation between Cabaret and Kite, we do not expect to receive any future royalty income related to the Kite license agreement. In conjunction with payment of amounts due to us, all outstanding litigation between the Company and Cabaret was dismissed.

Product Development Services Revenue

We provide product development services to customers, which are performed over time. These are services primarily performed at our facilities in East Windsor, New Jersey and Oakville, Ontario. As we intend to cease operations at the Oakville, Ontario facility by the first quarter of 2023, we expect to transition the product development services at the facility to one of our three U.S.-based manufacturing sites.

The duration of these development projects can be up 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 June 30, 2022, the aggregate amount of the transaction price allocated to the remaining performance obligations for all open product development services contracts was $0.3 million. We expect to satisfy these performance obligations within the next nine months.

Credit Concentration

Our customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and pharmaceutical companies.

During the three and six months ended June 30, 2022 and 2021 we had three customers that accounted for 10% or more of net revenues. As of June 30, 2022, accounts receivable from these customers totaled 83% of accounts receivable, net.

The three customers represent the total percentage of net revenues as follows:

Three Months Ended

Six Months Ended

June 30, 

June 30, 

June 30, 

June 30, 

    

2022

    

2021

    

2022

    

    

2021

    

Customer 1

23

%

34

%

27

%

29

%

Customer 2

19

%

26

%

19

%

22

%

Customer 3

15

%

14

%

14

%

14

%