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v3.23.1

Revenues | 3 Months Ended
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Mar. 31, 2023
Revenue from Contract with Customer [Abstract] |
Revenues | Product Revenue Revenue by product is summarized as follows:
|  | For the Three Months Ended March 31,
|  | 2023 |  | 2022
(In millions) |  | United States |  | Rest of World |  | Total |  | United States |  | Rest of World |  | Total
Multiple Sclerosis (MS): |  |  |  |  |  |  |  |  |  |  |  |
TECFIDERA |  | $ | 74.7 |  |  | $ | 199.8 |  |  | $ | 274.5 |  |  | $ | 117.1 |  |  | $ | 292.8 |  |  | $ | 409.9 |
VUMERITY |  | 93.5 |  |  | 14.7 |  |  | 108.2 |  |  | 125.2 |  |  | 2.8 |  |  | 128.0 |
Total Fumarate |  | 168.2 |  |  | 214.5 |  |  | 382.7 |  |  | 242.3 |  |  | 295.6 |  |  | 537.9 |
AVONEX |  | 102.6 |  |  | 69.8 |  |  | 172.4 |  |  | 148.0 |  |  | 81.6 |  |  | 229.6 |
PLEGRIDY |  | 29.9 |  |  | 43.3 |  |  | 73.2 |  |  | 34.3 |  |  | 45.7 |  |  | 80.0 |
Total Interferon |  | 132.5 |  |  | 113.1 |  |  | 245.6 |  |  | 182.3 |  |  | 127.3 |  |  | 309.6 |
TYSABRI |  | 245.4 |  |  | 227.4 |  |  | 472.8 |  |  | 284.5 |  |  | 236.3 |  |  | 520.8 |
FAMPYRA |  | — |  |  | 24.1 |  |  | 24.1 |  |  | — |  |  | 26.2 |  |  | 26.2 |
Subtotal: MS |  | 546.1 |  |  | 579.1 |  |  | 1,125.2 |  |  | 709.1 |  |  | 685.4 |  |  | 1,394.5 |
Spinal Muscular Atrophy: |  |  |  |  |  |  |  |  |  |  |  |
SPINRAZA |  | 146.7 |  |  | 296.6 |  |  | 443.3 |  |  | 163.3 |  |  | 309.2 |  |  | 472.5 |
Biosimilars: |  |  |  |  |  |  |  |  |  |  |  |
BENEPALI |  | — |  |  | 109.0 |  |  | 109.0 |  |  | — |  |  | 114.7 |  |  | 114.7 |
IMRALDI |  | — |  |  | 54.4 |  |  | 54.4 |  |  | — |  |  | 57.1 |  |  | 57.1 |
FLIXABI |  | — |  |  | 20.4 |  |  | 20.4 |  |  | — |  |  | 22.5 |  |  | 22.5 |
BYOOVIZ |  | 8.2 |  |  | 0.4 |  |  | 8.6 |  |  | — |  |  | — |  |  | — |
Subtotal: Biosimilars |  | 8.2 |  |  | 184.2 |  |  | 192.4 |  |  | — |  |  | 194.3 |  |  | 194.3 |
Other(1) |  | 0.4 |  |  | 2.0 |  |  | 2.4 |  |  | 2.8 |  |  | 2.2 |  |  | 5.0 |
Total product revenue |  | $ | 701.4 |  |  | $ | 1,061.9 |  |  | $ | 1,763.3 |  |  | $ | 875.2 |  |  | $ | 1,191.1 |  |  | $ | 2,066.3 |
(1) Other includes FUMADERM and ADUHELM. We recognized revenue from two wholesalers accounting for 27.3% and 7.4% of gross product revenue for the three months ended March 31, 2023, and 26.3% and 10.5% of gross product revenue for the three months ended March 31, 2022. An analysis of the change in reserves for discounts and allowances is summarized as follows:
(In millions) |  | Discounts |  | Contractual Adjustments |  | Returns |  | Total
Balance, December 31, 2022 |  | $ | 153.8 |  |  | $ | 857.7 |  |  | $ | 23.5 |  |  | $ | 1,035.0 |
Current provisions relating to sales in current year |  | 182.3 |  |  | 638.0 |  |  | 3.5 |  |  | 823.8 |
Adjustments relating to prior years |  | (1.1) |  |  | (8.1) |  |  | 1.0 |  |  | (8.2) |
Payments/credits relating to sales in current year |  | (94.0) |  |  | (261.8) |  |  | (1.0) |  |  | (356.8) |
Payments/credits relating to sales in prior years |  | (73.3) |  |  | (368.1) |  |  | (7.4) |  |  | (448.8) |
Balance, March 31, 2023 |  | $ | 167.7 |  |  | $ | 857.7 |  |  | $ | 19.6 |  |  | $ | 1,045.0 |
The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows:
(In millions) |  | As of March 31, 2023 |  | As of December 31, 2022
Reduction of accounts receivable |  | $ | 137.8 |  |  | $ | 143.4 |
Component of accrued expense and other |  | 907.2 |  |  | 891.6 |
Total revenue-related reserves |  | $ | 1,045.0 |  |  | $ | 1,035.0 |
Revenue from LEQEMBI Collaboration In January 2023 the FDA granted accelerated approval of LEQEMBI, which became commercially available in the U.S. during the first quarter of 2023. Upon commercialization, we began recognizing commercial profits and losses related to the LEQEMBI Collaboration Agreement on a net basis as a separate component of total revenue within our condensed consolidated income statements, as we are not the principal. For the three months ended March 31, 2023, we recognized a reduction to revenue of approximately $18.9 million, reflecting our net profit-share of the LEQEMBI Collaboration results in the U.S. For additional information on our collaboration arrangements with Eisai, please read Note 16, Collaborative and Other Relationships, to these condensed consolidated financial statements. Revenue from Anti-CD20 Therapeutic Programs Revenue from anti-CD20 therapeutic programs is summarized in the table below. For the purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN.
|  | For the Three Months Ended March 31, |  |
(In millions) |  | 2023 |  | 2022 |  |  |  |
Royalty revenue on sales of OCREVUS |  | $ | 283.6 |  |  | $ | 252.3 |  |  |  |  |
Biogen’s share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO |  | 112.5 |  |  | 143.2 |  |  |  |  |
Other revenue from anti-CD20 therapeutic programs |  | 3.4 |  |  | 3.9 |  |  |  |  |
Total revenue from anti-CD20 therapeutic programs |  | $ | 399.5 |  |  | $ | 399.4 |  |  |  |  |
For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in our 2022 Form 10-K. Contract Manufacturing, Royalty and Other Revenue Contract manufacturing, royalty and other revenue is summarized in the table below.
|  | For the Three Months Ended March 31, |  |
(In millions) |  | 2023 |  | 2022 |  |  |  |
Contract manufacturing revenue |  | $ | 306.9 |  |  | $ | 47.5 |  |  |  |  |
Royalty and other revenue |  | 12.2 |  |  | 18.6 |  |  |  |  |
Total contract manufacturing, royalty and other revenue |  | $ | 319.1 |  |  | $ | 66.1 |  |  |  |  |
Contract Manufacturing Revenue Contract manufacturing revenue primarily reflects amounts earned under contract manufacturing agreements with our strategic customers. During the first quarter of 2023 we began recognizing contract manufacturing revenue for LEQEMBI, upon accelerated approval of LEQEMBI in the U.S. Prior to accelerated approval, contract manufacturing amounts related to LEQEMBI were recognized in research and development within our condensed consolidated income statements. Royalty and Other Revenue Royalty and other revenue primarily reflects the royalties we receive from net sales on products related to patents that we have out-licensed, as well as royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis. For additional information on our license arrangements with Samsung Bioepis, please read Note 16, Collaborative and Other Relationships, to these condensed consolidated financial statements.

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- Definition The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -URI https://asc.fasb.org/topic&trid=49130388 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 10 -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130551-203045 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 13 -Subparagraph (b)(2) -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130556-203045 Reference 4: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 12 -Subparagraph (b) -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045 Reference 5: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 9 -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130550-203045 Reference 6: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 12 -Subparagraph (e) -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045 Reference 7: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 12 -Subparagraph (a) -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045 Reference 8: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 12 -Subparagraph (d) -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045 Reference 9: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 15 -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130558-203045 Reference 10: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 12 -Subparagraph (c) -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045 + Details
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