Revenues |
Revenues disaggregated by category were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross product sales |
|
$ |
20,318 |
|
$ |
14,348 |
|
$ |
54,042 |
|
$ |
36,745 |
|
Discounts and allowances |
|
|
(4,029) |
|
|
(2,632) |
|
|
(10,099) |
|
|
(6,802) |
|
Product sales, net |
|
$ |
16,289 |
|
$ |
11,716 |
|
$ |
43,943 |
|
$ |
29,943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues from collaborations: |
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|
|
|
|
|
|
|
|
|
|
|
|
License revenues |
|
|
2,100 |
|
|
7,750 |
|
|
41,958 |
|
|
12,249 |
|
Research and development services and others |
|
|
— |
|
|
1,391 |
|
|
4,270 |
|
|
1,696 |
|
Total revenues from collaborations |
|
|
2,100 |
|
|
9,141 |
|
|
46,228 |
|
|
13,945 |
|
Total revenues |
|
$ |
18,389 |
|
$ |
20,857 |
|
$ |
90,171 |
|
$ |
43,888 |
|
The following table summarizes revenues from each of our customers who individually accounted for 10% or more (wherein * denotes less than 10%) of our total revenues (as a percentage of total revenues):
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
ASD Healthcare and Oncology Supply |
|
|
48% |
|
|
28% |
|
|
26% |
|
|
34% |
|
McKesson Specialty Care Distribution Corporation |
|
|
34% |
|
|
22% |
|
|
20% |
|
|
27% |
|
Daiichi |
|
|
11% |
|
|
— |
|
|
* |
|
|
— |
|
Aclaris |
|
|
— |
|
|
19% |
|
|
— |
|
|
* |
|
Celgene |
|
|
— |
|
|
18% |
|
|
— |
|
|
* |
|
Grifols |
|
|
— |
|
|
* |
|
|
49% |
|
|
11% |
|
We commenced commercial sale of TAVALISSE in the U.S. in May 2018 after FDA approval in April 2018. Our Marketing Authorization Application (MAA) for fostamatinib for the treatment of chronic ITP in adult patients who are refractory to other treatments was approved by the EC in January 2020. Fostamatinib is marketed in Europe under the brand name TAVLESSE™ (fostamatinib). Grifols launched TAVLESSE™ in the UK and Germany in July 2020, and expects a phased roll-out over the next 18 months across Europe.
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, 2020 and 2019 (in thousands):
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|
|
|
|
|
|
|
|
|
|
|
|
|
Chargebacks, |
|
Government |
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|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chargebacks, |
|
Government |
|
|
|
|
|
|
|
|
Discounts and |
|
and Other |
|
|
|
|
|
|
|
|
Fees |
|
Rebates |
|
Returns |
|
Total |
Balance at January 1, 2019 |
|
$ |
622 |
|
$ |
843 |
|
$ |
170 |
|
$ |
1,635 |
Provision related to current period sales |
|
|
3,561 |
|
|
2,296 |
|
|
99 |
|
|
5,956 |
Credit or payments made during the period |
|
|
(2,932) |
|
|
(1,298) |
|
|
— |
|
|
(4,230) |
Balance at September 30, 2019 |
|
$ |
1,251 |
|
$ |
1,841 |
|
$ |
269 |
|
$ |
3,361 |
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.
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