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Revenues
9 Months Ended
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,
20242023
(In millions)United
States
Rest of
World
TotalUnited
States
Rest of
World
Total
Multiple Sclerosis:
TECFIDERA$40.1 $192.7 $232.8 $58.1 $181.4 $239.5 
VUMERITY134.9 23.2 158.1 148.8 16.7 165.5 
Total Fumarate175.0 215.9 390.9 206.9 198.1 405.0 
AVONEX115.6 60.6 176.2 148.7 63.5 212.2 
PLEGRIDY27.9 33.4 61.3 31.4 34.1 65.5 
Total Interferon143.5 94.0 237.5 180.1 97.6 277.7 
TYSABRI227.5 178.6 406.1 244.8 211.5 456.3 
FAMPYRA— 19.4 19.4 — 20.0 20.0 
Subtotal: Multiple Sclerosis546.0 507.9 1,053.9 631.8 527.2 1,159.0 
Rare Disease:
SPINRAZA153.1 228.3 381.4 150.5 297.7 448.2 
SKYCLARYS(1)
81.8 20.5 102.3 — — — 
QALSODY(2)
5.5 5.6 11.1 1.6 0.1 1.7 
Subtotal: Rare Disease240.4 254.4 494.8 152.1 297.8 449.9 
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: Biosimilars4.3 192.3 196.6 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: Other22.3 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,
20242023
(In millions)United
States
Rest of
World
TotalUnited
States
Rest of
World
Total
Multiple Sclerosis:
TECFIDERA$127.9 $611.4 $739.3 $199.3 $568.9 $768.2 
VUMERITY385.0 66.4 451.4 372.6 47.3 419.9 
Total Fumarate512.9 677.8 1,190.7 571.9 616.2 1,188.1 
AVONEX344.0 193.5 537.5 397.2 207.7 604.9 
PLEGRIDY84.7 109.8 194.5 95.4 125.4 220.8 
Total Interferon428.7 303.3 732.0 492.6 333.1 825.7 
TYSABRI690.0 609.6 1,299.6 750.1 662.1 1,412.2 
FAMPYRA— 57.3 57.3 — 67.5 67.5 
Subtotal: Multiple Sclerosis1,631.6 1,648.0 3,279.6 1,814.6 1,678.9 3,493.5 
Rare Disease:
SPINRAZA458.9 692.9 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 Disease703.8 749.0 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: Biosimilars19.1 572.5 591.6 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: Other51.3 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)DiscountsContractual
Adjustments
ReturnsTotal
Balance, December 31, 2023$173.3 $857.1 $31.6 $1,062.0 
Current provisions relating to sales in current year605.1 2,004.7 15.6 2,625.4 
Adjustments relating to prior years7.6 (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, 2024As of December 31, 2023
Reduction of accounts receivable$150.7 $135.5 
Component of accrued expense and other1,000.3 926.5 
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)2024202320242023
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 LUNSUMIO94.8 98.9 285.3 315.0 
Other revenue from anti-CD20 therapeutic programs4.6 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)2024202320242023
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.