Quarterly report pursuant to Section 13 or 15(d)

Revenues

v3.21.2
Revenues
9 Months Ended
Sep. 30, 2021
Revenues  
Revenues

7.

Revenues

Revenues disaggregated by category were as follows (in thousands):

Three Months Ended 

Nine Months Ended 

September 30, 

September 30, 

2021

    

2020

2021

    

2020

Product sales:

Gross product sales

$

20,546

$

20,318

$

58,692

$

54,042

Discounts and allowances

(4,534)

(4,029)

(13,251)

(10,099)

Total product sales, net

16,012

16,289

45,441

43,943

Revenues from collaborations:

License revenues

2,431

70,354

39,858

Development milestones

1,875

2,100

1,875

2,100

Research and development services and others

225

1,657

4,270

Total revenues from collaborations

4,531

2,100

73,886

46,228

Government contract

1,000

9,500

Total revenues

$

21,543

$

18,389

$

128,827

$

90,171

The following table summarizes the percentages of revenues from each of our customers who individually accounted for 10% or more (wherein * denotes less than 10%) of the total net product sales and revenues from collaborations:

Three Months Ended 

Nine Months Ended 

September 30, 

September 30, 

2021

    

2020

2021

    

2020

ASD Healthcare and Oncology Supply

25%

48%

15%

26%

McKesson Specialty Care Distribution Corporation

35%

34%

17%

20%

Lilly

12%

56%

Cardinal Healthcare

18%

*

*

*

Grifols

*

*

*

49%

Daiichi

*

11%

*

*

Our first and only FDA approved product, TAVALISSE®, was approved by the U.S. FDA in April 2018. We commenced commercial sale of TAVALISSE in the U.S. in May 2018. Fostamatinib is marketed in Europe under the

brand name TAVLESSE™ (fostamatinib). In July 2020, Grifols S.A. (Grifols) launched TAVLESSE in the United Kingdom (UK) and Germany. In September 2021, Grifols announced that it began commercializing TAVLESSE in France, Italy and Spain. In December 2020, the Scottish Medicines Consortium accepted TAVLESSE for use in NHS in Scotland.

In addition to the distribution agreements with our customers and SDs, we also enter into arrangements with specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of our products which reduced our gross product sales. Also refer to Revenue Recognition policy discussion in Note 3 above.

The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2021 and 2020 (in thousands):

Chargebacks,

Government

Discounts and

and Other

Fees

Rebates

Returns

Total

Balance at January 1, 2021

    

$

2,461

 

$

2,115

$

1,489

$

6,065

Provision related to current period sales

7,326

3,995

739

12,060

Credit or payments made during the period

(7,073)

(3,367)

(387)

(10,827)

Balance at September 30, 2021

 

$

2,714

$

2,743

$

1,841

$

7,298

Chargebacks,

Government

Discounts and

and Other

Fees

Rebates

Returns

Total

Balance at January 1, 2020

    

$

1,293

 

$

1,801

$

238

$

3,332

Provision related to current period sales

5,625

2,775

676

9,076

Adjustment related to prior period sales

(75)

(490)

565

Credit or payments made during the period

(5,020)

(2,407)

(72)

(7,499)

Balance at September 30, 2020

 

$

1,823

$

1,679

$

1,407

$

4,909

Of the $13.3 million discounts and allowances from gross product sales for the nine months ended September 30, 2021, $12.1 million was accounted for as additions to other accrued liabilities and $1.2 million as reductions in accounts receivable and prepaid and other current assets in the balance sheet. Other accrued liabilities related to the discounts and allowances had a remaining outstanding balance of $7.3 million as of September 30, 2021.

Of the $10.1 million discounts and allowances from gross product sales for the nine months ended September 30, 2020, $9.1 million was accounted for as additions to other accrued liabilities and $1.0 million as reductions in accounts receivable and prepaid and other current assets in the balance sheet. Other accrued liabilities related to the discounts and allowances had a remaining outstanding balance of $4.9 million as of September 30, 2020.