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Revenues | 9 Months Ended
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Sep. 30, 2024
Revenue from Contract with Customer [Abstract] |
Revenues | Product Revenue Revenue by product is summarized as follows:
|  | For the Three Months Ended September 30,
|  | 2024 |  | 2023
(In millions) |  | United States |  | Rest of World |  | Total |  | United States |  | Rest of World |  | Total
Multiple Sclerosis: |  |  |  |  |  |  |  |  |  |  |  |
TECFIDERA |  | $ | 40.1 |  |  | $ | 192.7 |  |  | $ | 232.8 |  |  | $ | 58.1 |  |  | $ | 181.4 |  |  | $ | 239.5 |
VUMERITY |  | 134.9 |  |  | 23.2 |  |  | 158.1 |  |  | 148.8 |  |  | 16.7 |  |  | 165.5 |
Total Fumarate |  | 175.0 |  |  | 215.9 |  |  | 390.9 |  |  | 206.9 |  |  | 198.1 |  |  | 405.0 |
AVONEX |  | 115.6 |  |  | 60.6 |  |  | 176.2 |  |  | 148.7 |  |  | 63.5 |  |  | 212.2 |
PLEGRIDY |  | 27.9 |  |  | 33.4 |  |  | 61.3 |  |  | 31.4 |  |  | 34.1 |  |  | 65.5 |
Total Interferon |  | 143.5 |  |  | 94.0 |  |  | 237.5 |  |  | 180.1 |  |  | 97.6 |  |  | 277.7 |
TYSABRI |  | 227.5 |  |  | 178.6 |  |  | 406.1 |  |  | 244.8 |  |  | 211.5 |  |  | 456.3 |
FAMPYRA |  | — |  |  | 19.4 |  |  | 19.4 |  |  | — |  |  | 20.0 |  |  | 20.0 |
Subtotal: Multiple Sclerosis |  | 546.0 |  |  | 507.9 |  |  | 1,053.9 |  |  | 631.8 |  |  | 527.2 |  |  | 1,159.0 |
Rare Disease: |  |  |  |  |  |  |  |  |  |  |  |
SPINRAZA |  | 153.1 |  |  | 228.3 |  |  | 381.4 |  |  | 150.5 |  |  | 297.7 |  |  | 448.2 |
SKYCLARYS(1) |  | 81.8 |  |  | 20.5 |  |  | 102.3 |  |  | — |  |  | — |  |  | — |
QALSODY(2) |  | 5.5 |  |  | 5.6 |  |  | 11.1 |  |  | 1.6 |  |  | 0.1 |  |  | 1.7 |
Subtotal: Rare Disease |  | 240.4 |  |  | 254.4 |  |  | 494.8 |  |  | 152.1 |  |  | 297.8 |  |  | 449.9 |
Biosimilars: |  |  |  |  |  |  |  |  |  |  |  |
BENEPALI |  | — |  |  | 118.1 |  |  | 118.1 |  |  | — |  |  | 112.8 |  |  | 112.8 |
IMRALDI |  | — |  |  | 54.1 |  |  | 54.1 |  |  | — |  |  | 54.4 |  |  | 54.4 |
FLIXABI |  | — |  |  | 16.2 |  |  | 16.2 |  |  | — |  |  | 20.2 |  |  | 20.2 |
BYOOVIZ(3) |  | 4.1 |  |  | 3.9 |  |  | 8.0 |  |  | 6.1 |  |  | 0.8 |  |  | 6.9 |
TOFIDENCE(4) |  | 0.2 |  |  | — |  |  | 0.2 |  |  | — |  |  | — |  |  | — |
Subtotal: Biosimilars |  | 4.3 |  |  | 192.3 |  |  | 196.6 |  |  | 6.1 |  |  | 188.2 |  |  | 194.3 |
Other: |  |  |  |  |  |  |  |  |  |  |  |
ZURZUVAE(5) |  | 22.0 |  |  | — |  |  | 22.0 |  |  | — |  |  | — |  |  | — |
Other(6) |  | 0.3 |  |  | 1.8 |  |  | 2.1 |  |  | 0.9 |  |  | 1.1 |  |  | 2.0 |
Subtotal: Other |  | 22.3 |  |  | 1.8 |  |  | 24.1 |  |  | 0.9 |  |  | 1.1 |  |  | 2.0 |
Total product revenue, net |  | $ | 813.0 |  |  | $ | 956.4 |  |  | $ | 1,769.4 |  |  | $ | 790.9 |  |  | $ | 1,014.3 |  |  | $ | 1,805.2 |
(1) SKYCLARYS was obtained as part of our acquisition of Reata in September 2023. SKYCLARYS became commercially available in the U.S. during the second quarter of 2023 and we began recognizing revenue from SKYCLARYS in the U.S. during the fourth quarter of 2023, subsequent to our acquisition. SKYCLARYS was approved and became commercially available in the E.U. during the first quarter of 2024. (2) QALSODY became commercially available in the U.S. during the second quarter of 2023 and commercially available in the E.U. during the second quarter of 2024. (3) BYOOVIZ became commercially available in certain international markets in 2023. (4) TOFIDENCE became commercially available in the U.S. during the second quarter of 2024. (5) ZURZUVAE became commercially available in the U.S. during the fourth quarter of 2023. (6) Other includes FUMADERM and ADUHELM.
|  | For the Nine Months Ended September 30,
|  | 2024 |  | 2023
(In millions) |  | United States |  | Rest of World |  | Total |  | United States |  | Rest of World |  | Total
Multiple Sclerosis: |  |  |  |  |  |  |  |  |  |  |  |
TECFIDERA |  | $ | 127.9 |  |  | $ | 611.4 |  |  | $ | 739.3 |  |  | $ | 199.3 |  |  | $ | 568.9 |  |  | $ | 768.2 |
VUMERITY |  | 385.0 |  |  | 66.4 |  |  | 451.4 |  |  | 372.6 |  |  | 47.3 |  |  | 419.9 |
Total Fumarate |  | 512.9 |  |  | 677.8 |  |  | 1,190.7 |  |  | 571.9 |  |  | 616.2 |  |  | 1,188.1 |
AVONEX |  | 344.0 |  |  | 193.5 |  |  | 537.5 |  |  | 397.2 |  |  | 207.7 |  |  | 604.9 |
PLEGRIDY |  | 84.7 |  |  | 109.8 |  |  | 194.5 |  |  | 95.4 |  |  | 125.4 |  |  | 220.8 |
Total Interferon |  | 428.7 |  |  | 303.3 |  |  | 732.0 |  |  | 492.6 |  |  | 333.1 |  |  | 825.7 |
TYSABRI |  | 690.0 |  |  | 609.6 |  |  | 1,299.6 |  |  | 750.1 |  |  | 662.1 |  |  | 1,412.2 |
FAMPYRA |  | — |  |  | 57.3 |  |  | 57.3 |  |  | — |  |  | 67.5 |  |  | 67.5 |
Subtotal: Multiple Sclerosis |  | 1,631.6 |  |  | 1,648.0 |  |  | 3,279.6 |  |  | 1,814.6 |  |  | 1,678.9 |  |  | 3,493.5 |
Rare Disease: |  |  |  |  |  |  |  |  |  |  |  |
SPINRAZA |  | 458.9 |  |  | 692.9 |  |  | 1,151.8 |  |  | 453.0 |  |  | 875.6 |  |  | 1,328.6 |
SKYCLARYS(1) |  | 230.4 |  |  | 49.9 |  |  | 280.3 |  |  | — |  |  | — |  |  | — |
QALSODY(2) |  | 14.5 |  |  | 6.2 |  |  | 20.7 |  |  | 2.5 |  |  | 0.1 |  |  | 2.6 |
Subtotal: Rare Disease |  | 703.8 |  |  | 749.0 |  |  | 1,452.8 |  |  | 455.5 |  |  | 875.7 |  |  | 1,331.2 |
Biosimilars: |  |  |  |  |  |  |  |  |  |  |  |
BENEPALI |  | — |  |  | 354.1 |  |  | 354.1 |  |  | — |  |  | 331.0 |  |  | 331.0 |
IMRALDI |  | — |  |  | 162.1 |  |  | 162.1 |  |  | — |  |  | 167.6 |  |  | 167.6 |
FLIXABI |  | — |  |  | 47.1 |  |  | 47.1 |  |  | — |  |  | 60.7 |  |  | 60.7 |
BYOOVIZ(3) |  | 18.1 |  |  | 9.2 |  |  | 27.3 |  |  | 21.3 |  |  | 1.2 |  |  | 22.5 |
TOFIDENCE(4) |  | 1.0 |  |  | — |  |  | 1.0 |  |  | — |  |  | — |  |  | — |
Subtotal: Biosimilars |  | 19.1 |  |  | 572.5 |  |  | 591.6 |  |  | 21.3 |  |  | 560.5 |  |  | 581.8 |
Other: |  |  |  |  |  |  |  |  |  |  |  |
ZURZUVAE(5) |  | 49.3 |  |  | — |  |  | 49.3 |  |  | — |  |  | — |  |  | — |
Other(6) |  | 2.0 |  |  | 5.6 |  |  | 7.6 |  |  | 1.9 |  |  | 5.9 |  |  | 7.8 |
Subtotal: Other |  | 51.3 |  |  | 5.6 |  |  | 56.9 |  |  | 1.9 |  |  | 5.9 |  |  | 7.8 |
Total product revenue, net |  | $ | 2,405.8 |  |  | $ | 2,975.1 |  |  | $ | 5,380.9 |  |  | $ | 2,293.3 |  |  | $ | 3,121.0 |  |  | $ | 5,414.3 |
(1) SKYCLARYS was obtained as part of our acquisition of Reata in September 2023. SKYCLARYS became commercially available in the U.S. during the second quarter of 2023 and we began recognizing revenue from SKYCLARYS in the U.S. during the fourth quarter of 2023, subsequent to our acquisition. SKYCLARYS was approved and became commercially available in the E.U. during the first quarter of 2024. (2) QALSODY became commercially available in the U.S. during the second quarter of 2023 and commercially available in the E.U. during the second quarter of 2024. (3) BYOOVIZ became commercially available in certain international markets in 2023. (4) TOFIDENCE became commercially available in the U.S. during the second quarter of 2024. (5) ZURZUVAE became commercially available in the U.S. during the fourth quarter of 2023. (6) Other includes FUMADERM and ADUHELM. We recognized revenue from two wholesalers accounting for 25.9% and 14.8% of gross product revenue for the three months ended September 30, 2024, and 25.6% and 12.9% of gross product revenue for the nine months ended September 30, 2024. We recognized revenue from two wholesalers accounting for 26.9% and 10.5% of gross product revenue for the three months ended September 30, 2023, and 27.1% and 9.1% of gross product revenue for the nine months ended September 30, 2023. 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, 2023 |  | $ | 173.3 |  |  | $ | 857.1 |  |  | $ | 31.6 |  |  | $ | 1,062.0 |
Current provisions relating to sales in current year |  | 605.1 |  |  | 2,004.7 |  |  | 15.6 |  |  | 2,625.4 |
Adjustments relating to prior years |  | 7.6 |  |  | (33.6) |  |  | 13.1 |  |  | (12.9) |
Payments/credits relating to sales in current year |  | (439.7) |  |  | (1,391.1) |  |  | (0.4) |  |  | (1,831.2) |
Payments/credits relating to sales in prior years |  | (160.8) |  |  | (514.1) |  |  | (17.4) |  |  | (692.3) |
Balance, September 30, 2024 |  | $ | 185.5 |  |  | $ | 923.0 |  |  | $ | 42.5 |  |  | $ | 1,151.0 |
The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows:
(In millions) |  | As of September 30, 2024 |  | As of December 31, 2023
Reduction of accounts receivable |  | $ | 150.7 |  |  | $ | 135.5 |
Component of accrued expense and other |  | 1,000.3 |  |  | 926.5 |
Total revenue-related reserves |  | $ | 1,151.0 |  |  | $ | 1,062.0 |
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 September 30, |  | For the Nine Months Ended September 30,
(In millions) |  | 2024 |  | 2023 |  | 2024 |  | 2023
Royalty revenue on sales of OCREVUS |  | $ | 346.8 |  |  | $ | 319.1 |  |  | $ | 985.8 |  |  | $ | 928.2 |
Biogen’s share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO |  | 94.8 |  |  | 98.9 |  |  | 285.3 |  |  | 315.0 |
Other revenue from anti-CD20 therapeutic programs |  | 4.6 |  |  | 2.9 |  |  | 13.6 |  |  | 10.6 |
Total revenue from anti-CD20 therapeutic programs |  | $ | 446.2 |  |  | $ | 420.9 |  |  | $ | 1,284.7 |  |  | $ | 1,253.8 |
For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to these condensed consolidated financial statements. Contract Manufacturing, Royalty and Other Revenue Contract manufacturing, royalty and other revenue is summarized in the table below.
|  | For the Three Months Ended September 30, |  | For the Nine Months Ended September 30,
(In millions) |  | 2024 |  | 2023 |  | 2024 |  | 2023
Contract manufacturing revenue |  | $ | 221.9 |  |  | $ | 252.9 |  |  | $ | 474.1 |  |  | $ | 742.9 |
Royalty and other revenue |  | 28.3 |  |  | 51.3 |  |  | 81.5 |  |  | 38.3 |
Total contract manufacturing, royalty and other revenue |  | $ | 250.2 |  |  | $ | 304.2 |  |  | $ | 555.6 |  |  | $ | 781.2 |
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, our share of contract manufacturing amounts related to LEQEMBI were recognized in research and development expense within our condensed consolidated statements of income. Royalty and Other Revenue Royalty and other revenue primarily reflects royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis and our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties, as we are not the principal, as well as royalties we receive from net sales on products related to patents that we have out-licensed. For additional information on our license arrangements with Samsung Bioepis and our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships, to these condensed consolidated financial statements.

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