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Revenues
9 Months Ended
Sep. 30, 2023
Revenue from Contract with Customer [Abstract]  
Revenues
Product Revenue
Revenue by product is summarized as follows:
 For the Three Months Ended September 30,
20232022
(In millions)United
States
Rest of
World
TotalUnited
States
Rest of
World
Total
Multiple Sclerosis:
TECFIDERA$58.1 $181.4 $239.5 $92.5 $246.5 $339.0 
VUMERITY148.8 16.7 165.5 127.9 9.9 137.8 
Total Fumarate206.9 198.1 405.0 220.4 256.4 476.8 
AVONEX148.7 63.5 212.2 174.8 80.3 255.1 
PLEGRIDY31.4 34.1 65.5 39.7 41.2 80.9 
Total Interferon180.1 97.6 277.7 214.5 121.5 336.0 
TYSABRI244.8 211.5 456.3 273.0 232.5 505.5 
FAMPYRA— 20.0 20.0 — 22.0 22.0 
Subtotal: MS631.8 527.2 1,159.0 707.9 632.4 1,340.3 
Spinal Muscular Atrophy:
SPINRAZA150.5 297.7 448.2 140.2 290.9 431.1 
Subtotal: SMA150.5 297.7 448.2 140.2 290.9 431.1 
Biosimilars:
BENEPALI— 112.8 112.8 — 110.2 110.2 
IMRALDI— 54.4 54.4 — 57.7 57.7 
FLIXABI— 20.2 20.2 — 19.0 19.0 
BYOOVIZ(1)
6.1 0.8 6.9 0.7 — 0.7 
Subtotal: Biosimilars6.1 188.2 194.3 0.7 186.9 187.6 
Other(2)
2.5 1.2 3.7 1.6 1.5 3.1 
Total product revenue$790.9 $1,014.3 $1,805.2 $850.4 $1,111.7 $1,962.1 
(1) BYOOVIZ became commercially available in the U.S. during the third quarter of 2022 and commercially available in international markets in 2023.
(2) Other includes FUMADERM, ADUHELM and QALSODY, which became commercially available in the U.S. during the second quarter of 2023.
 For the Nine Months Ended September 30,
20232022
(In millions)United
States
Rest of
World
TotalUnited
States
Rest of
World
Total
Multiple Sclerosis:
TECFIDERA$199.3 $568.9 $768.2 $330.3 $816.5 $1,146.8 
VUMERITY372.6 47.3 419.9 383.0 19.6 402.6 
Total Fumarate571.9 616.2 1,188.1 713.3 836.1 1,549.4 
AVONEX397.2 207.7 604.9 493.8 249.6 743.4 
PLEGRIDY95.4 125.4 220.8 114.2 138.2 252.4 
Total Interferon492.6 333.1 825.7 608.0 387.8 995.8 
TYSABRI750.1 662.1 1,412.2 849.4 693.1 1,542.5 
FAMPYRA— 67.5 67.5 — 73.7 73.7 
Subtotal: MS1,814.6 1,678.9 3,493.5 2,170.7 1,990.7 4,161.4 
Spinal Muscular Atrophy:
SPINRAZA453.0 875.6 1,328.6 443.3 891.4 1,334.7 
Subtotal: SMA453.0 875.6 1,328.6 443.3 891.4 1,334.7 
Biosimilars:
BENEPALI— 331.0 331.0 — 340.7 340.7 
IMRALDI— 167.6 167.6 — 172.4 172.4 
FLIXABI— 60.7 60.7 — 62.0 62.0 
BYOOVIZ(1)
21.3 1.2 22.5 1.2 — 1.2 
Subtotal: Biosimilars21.3 560.5 581.8 1.2 575.1 576.3 
Other(2)
4.4 6.0 10.4 4.5 6.4 10.9 
Total product revenue$2,293.3 $3,121.0 $5,414.3 $2,619.7 $3,463.6 $6,083.3 
(1) BYOOVIZ became commercially available in the U.S. during the third quarter of 2022 and commercially available in international markets in 2023.
(2) Other includes FUMADERM, ADUHELM and QALSODY, which became commercially available in the U.S. during the second quarter of 2023.
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.
We recognized revenue from two wholesalers accounting for 26.9% and 10.5% of gross product revenue for the three months ended September 30, 2022, and 26.8% and 10.7% of gross product revenue for the nine months ended September 30, 2022.
An analysis of the change in reserves for discounts and allowances is summarized as follows:
(In millions)DiscountsContractual
Adjustments
ReturnsTotal
Balance, December 31, 2022$153.8 $857.7 $23.5 $1,035.0 
Current provisions relating to sales in current year554.1 1,983.6 14.2 2,551.9 
Adjustments relating to prior years0.2 (24.5)19.9 (4.4)
Payments/credits relating to sales in current year(410.4)(1,362.3)(2.0)(1,774.7)
Payments/credits relating to sales in prior years(137.5)(574.8)(23.2)(735.5)
Balance, September 30, 2023$160.2 $879.7 $32.4 $1,072.3 
The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows:
(In millions)As of September 30, 2023As of December 31, 2022
Reduction of accounts receivable$131.4 $143.4 
Component of accrued expense and other940.9 891.6 
Total revenue-related reserves$1,072.3 $1,035.0 
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)2023202220232022
Royalty revenue on sales of OCREVUS$319.1 $281.1 $928.2 $825.2 
Biogen’s share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO(1)
98.9 131.1 315.0 414.2 
Other revenue from anti-CD20 therapeutic programs2.9 4.7 10.6 13.2 
Total revenue from anti-CD20 therapeutic programs$420.9 $416.9 $1,253.8 $1,252.6 
(1) LUNSUMIO became commercially available in the U.S. during the first quarter of 2023.
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 September 30,For the Nine Months Ended September 30,
(In millions)2023202220232022
Contract manufacturing revenue$252.9 $114.2 $742.9 $242.9 
Royalty and other revenue51.3 15.3 38.3 50.6 
Total contract manufacturing, royalty and other revenue$304.2 $129.5 $781.2 $293.5 
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 expense 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 and our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties, as we are not the principal.
During the third quarter of 2023 we recorded a reclassification of $38.7 million in LEQEMBI collaboration costs from other revenue to selling, general and administrative expense within our condensed consolidated statements of income. We determined that this reclassification does not materially impact the current or previously issued condensed consolidated financial statements.
For additional information on our collaboration arrangements with Eisai and our license arrangements with Samsung Bioepis, please read Note 19, Collaborative and Other Relationships, to these condensed consolidated financial statements.