Revenues

6 Months Ended

Jun. 30, 2023

Revenue from Contract with Customer [Abstract]

Revenues

Product Revenue

Revenue by product is summarized as follows:

	For the Three Months Ended June 30,
	2023						2022
(In millions)	United States		Rest of World		Total		United States		Rest of World		Total
Multiple Sclerosis:
TECFIDERA	$	66.5	$	187.7	$	254.2	$	120.7	$	277.2	$	397.9
VUMERITY	130.3		15.9		146.2		129.9		6.9		136.8
Total Fumarate	196.8		203.6		400.4		250.6		284.1		534.7
AVONEX	145.9		74.4		220.3		171.0		87.7		258.7
PLEGRIDY	34.1		48.0		82.1		40.2		51.3		91.5
Total Interferon	180.0		122.4		302.4		211.2		139.0		350.2
TYSABRI	259.9		223.2		483.1		291.9		224.3		516.2
FAMPYRA	—		23.4		23.4		—		25.5		25.5
Subtotal: MS	636.7		572.6		1,209.3		753.7		672.9		1,426.6
Spinal Muscular Atrophy:
SPINRAZA	155.8		281.3		437.1		139.8		291.3		431.1
Subtotal: SMA	155.8		281.3		437.1		139.8		291.3		431.1
Biosimilars:
BENEPALI	—		109.2		109.2		—		115.8		115.8
IMRALDI	—		58.8		58.8		—		57.6		57.6
FLIXABI	—		20.1		20.1		—		20.5		20.5
BYOOVIZ(1)	7.0		—		7.0		0.5		—		0.5
Subtotal: Biosimilars	7.0		188.1		195.1		0.5		193.9		194.4
Other(2)	1.5		2.8		4.3		0.1		2.7		2.8
Total product revenue	$	801.0	$	1,044.8	$	1,845.8	$	894.1	$	1,160.8	$	2,054.9

(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 Six Months Ended June 30,
	2023						2022
(In millions)	United States		Rest of World		Total		United States		Rest of World		Total
Multiple Sclerosis:
TECFIDERA	$	141.2	$	387.5	$	528.7	$	237.8	$	570.0	$	807.8
VUMERITY	223.8		30.6		254.4		255.1		9.7		264.8
Total Fumarate	365.0		418.1		783.1		492.9		579.7		1,072.6
AVONEX	248.5		144.2		392.7		319.0		169.3		488.3
PLEGRIDY	64.0		91.3		155.3		74.5		97.0		171.5
Total Interferon	312.5		235.5		548.0		393.5		266.3		659.8
TYSABRI	505.3		450.6		955.9		576.4		460.6		1,037.0
FAMPYRA	—		47.5		47.5		—		51.7		51.7
Subtotal: MS	1,182.8		1,151.7		2,334.5		1,462.8		1,358.3		2,821.1
Spinal Muscular Atrophy:
SPINRAZA	302.5		577.9		880.4		303.1		600.5		903.6
Subtotal: SMA	302.5		577.9		880.4		303.1		600.5		903.6
Biosimilars:
BENEPALI	—		218.2		218.2		—		230.5		230.5
IMRALDI	—		113.2		113.2		—		114.7		114.7
FLIXABI	—		40.5		40.5		—		43.0		43.0
BYOOVIZ(1)	15.2		0.4		15.6		0.5		—		0.5
Subtotal: Biosimilars	15.2		372.3		387.5		0.5		388.2		388.7
Other(2)	1.9		4.8		6.7		2.9		4.9		7.8
Total product revenue	$	1,502.4	$	2,106.7	$	3,609.1	$	1,769.3	$	2,351.9	$	4,121.2

(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 27.0% and 9.3% of gross product revenue for the three months ended June 30, 2023, and 27.2% and 8.4% of gross product revenue for the six months ended June 30, 2023.

We recognized revenue from two wholesalers accounting for 27.4% and 11.2% of gross product revenue for the three months ended June 30, 2022, and 26.8% and 10.8% of gross product revenue for the six months ended June 30, 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	381.8		1,324.7		7.8		1,714.3
Adjustments relating to prior years	0.8		(19.6)		6.2		(12.6)
Payments/credits relating to sales in current year	(257.5)		(757.4)		(1.8)		(1,016.7)
Payments/credits relating to sales in prior years	(113.7)		(477.7)		(14.1)		(605.5)
Balance, June 30, 2023	$	165.2	$	927.7	$	21.6	$	1,114.5

The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows:

(In millions)	As of June 30, 2023		As of December 31, 2022
Reduction of accounts receivable	$	149.8	$	143.4
Component of accrued expense and other	964.7		891.6
Total revenue-related reserves	$	1,114.5	$	1,035.0

Revenue from LEQEMBI Collaboration

In July 2023 the FDA granted traditional approval of LEQEMBI. Prior to receiving traditional approval, LEQEMBI had been granted accelerated approval by the FDA in January 2023, at which time it became commercially available in the U.S. Upon commercialization of LEQEMBI, we began recognizing our portion of the profit share on a net basis as a separate component of total revenue within revenue from LEQEMBI collaboration in our condensed consolidated income statements, as we are not the principal.

For the three and six months ended June 30, 2023, we recognized reductions to revenue of approximately $20.7 million and $39.6 million, respectively, 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 June 30,				For the Six Months Ended June 30,
(In millions)	2023		2022		2023		2022
Royalty revenue on sales of OCREVUS	$	325.5	$	291.8	$	609.1	$	544.1
Biogen’s share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO(1)	103.6		139.9		216.1		283.1
Other revenue from anti-CD20 therapeutic programs	4.3		4.6		7.7		8.5
Total revenue from anti-CD20 therapeutic programs	$	433.4	$	436.3	$	832.9	$	835.7

(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 June 30,				For the Six Months Ended June 30,
(In millions)	2023		2022		2023		2022
Contract manufacturing revenue	$	183.1	$	81.2	$	490.0	$	128.7
Royalty and other revenue	14.4		16.7		26.6		35.3
Total contract manufacturing, royalty and other revenue	$	197.5	$	97.9	$	516.6	$	164.0

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.