Document

EX-99.1 2 exhibit991-q32024pressrele.htm EX-99.1 Document

新闻发布

剑桥，马萨诸塞州- 2024年10月30日

渤健公司报告2024年第三季度业绩，并上调2024年全年财务指导

2024年第三季度营业收入25亿美元；按照普通会计准则计算，摊薄后每股收益为2.66美元；非普通会计准则计算，摊薄后每股收益为4.08美元

持续推进商业投资组合

•阿尔茨海默症、罕见疾病和抑郁症产品推出分别实现了连续的营业收入增长；第三季度产品推出的总营业收入继续抵消了多发性硬化产品营业收入同比下降

•LEQEMBI第三季度全球市场销售额约为6700万美元，其中美国市场销售额约为3900万美元；欧盟CHMP重新审查预计将于今年完成

•欧洲专利局反对部门维持TECFIDERA欧盟专利，涵盖二甲基富马酸剂量，有效期至2028年2月。

发展项目取得了几个重要里程碑，突显了后期阶段管线的数十亿美元潜在机会。

•Dapirolizumab pegol第3期研究在系统性红斑狼疮中达到了主要终点；详细数据将于11月在美国风湿病学院年会上发布；UCb和渤健公司计划在2024年启动第二期3研究

•BIIB080的第2阶段CELIA研究，一种针对阿尔茨海默病治疗中的tau的反义寡核苷酸，已经完成招募，预计于2026年发布结果。

•Felzartamab获得FDA突破性疗法认可，用于治疗肾移植接受者的抗体介导的排斥反应；在2024年美国肾脏学会肾周活动上发布了新的IgA肾病数据

•Nusinersen更高剂量方案在2/3期DEVOTE研究的关键队列中显示出显著改善；渤健公司计划全球提交监管申请

提高2024财年全年财务指引：预计非GAAP摊薄后每股收益为16.10美元至16.60美元，相较于2023全年，预计非GAAP摊薄后每股收益增长约11%。

•维持对2024年全年总营业收入较2023年全年下降个位数百分比的预期，核心药品营业收入预计与2023年全年大致持平

•现在预计营业收入将在2023年整年基础上保持高中青少年百分比增长，同时保持中个位数营业利润率改善的预期。

生物源公司（纳斯达克：BIIB）今天报告了2024年第三季度财务业绩。就本季度发表评论，总裁兼首席执行官克里斯托弗·A·维哈伯先生表示：

在第三季度，渤健公司在实现返向可持续增长目标方面取得了持续进展。我们继续看到正在进行的产品推出势头，并对我们的产品线潜力感到越来越兴奋。在本季度，我们在产品线后期关键领域取得了几项重大积极进展，我们认为这些进展凸显了对患者和股东潜在价值。重要的是，達璞单抗以及最近在IgAN中费扎鲁单抗数据的正面结果，支持了我们在免疫学领域发展业界领先产品线的努力，我们正在构建基于数据洞见并增强我们的能力以为潜在未来推出做准备。

财务亮点


	Q3 '24	Q3 '23	△	r (CC*)
总营收（以百万美元计）	$2,466	$2,530	(3)%	(3)%
摊薄后每股收益（按美国通用会计原则GAAP）	$2.66	$(0.47)	666%	无数据
摊薄后每股收益（非按美国通用会计原则GAAP）	$4.08	$4.36	(6)%	无数据

注意：百分比变化表示有利/（不利）与上一年同期相比。

N/A = 不适用。

* 以恒定货币兑换率（CC）计算的营业收入增长百分比变化不包括外汇汇率变动和套期保值收益或损失的影响。外币营业收入价值将使用上一个日历年底的汇率转换为美元。

GAAP和Non-GAAP财务指标的对比，请参见本新闻稿末尾的表4。

营业收入总结


（单位百万）	Q3 '24	Q3 '23	△	r (CC*)
多发性硬化（MS）产品营业收入(1)	$1,054	$1,159	(9)%	(9)%
罕见病营业收入(2)	$495	$450	10%	10%
生物仿制药收入	$197	$194	1%	—%
其他产品收入(3)	$24	$2	NMF	NMF
总产品收入	$1,769	$1,805	(2)%	(2)%
抗CD20治疗项目的营业收入	$446	$421	6%	6%
合同制造、特许权和其他收入	$250	$304	(18)%	(19)%
总收入	$2,466	$2,530	(3)%	(3)%

注意：百分比变化表示有利/(不利)相对于去年同期。由于四舍五入，数字可能无法对应或重新计算。

NMF = 无实质意义数字。

(1) 多发性硬化症包括TECFIDERA®、VUMERITY®、AVONEX®、PLEGRIDY®、TYSABRI®和FAMPYRA™。

(2) 罕见疾病包括SPINRAZA®、SKYCLARYS®和QALSODY®。

(3) 其他包括ADUHELM®、FUMADERM™和ZURZUVAE™。

•2024年第三季度ZURZUVAE的营业收入约为2200万美元。

费用总结


（单位：百万）	Q3 '24	Q3 '23	△
GAAP 销售成本*	$639	$660	3%
占总收入的百分比	26%	26%
非公认会计准则销售成本*	$593	$660	10%
占总收入的百分比	24%	26%
GAAP 研发费用	$543	$736	26%
非公认会计准则研发费用	$491	$539	9%
GAAP SG&A 费用	$588	$788	25%
非公认会计准则销售和收支出	$556	$553	(1)%

注：百分比变化表示相对于去年同期的有利/(不利)

* 不包括取得无形资产的摊销和减值

•2024年第三季度的营业成本（GAAP和非GAAP）占营业收入的比例下降，主要是由产品组合驱动的，特别是来自新产品的营业收入同比增长

产品发布和合同制造业营业收入下降，以及较低的闲置产能费用。

•2024年第三季度与2023年第三季度相比，GAAP研发支出大约减少了19400万美元，主要原因是与Reata Pharmaceuticals, Inc.（Reata）收购相关的2023年约1.97亿美元的股权激励费用，以及公司2024年实施的与研发重点和适合增长倡议相关的成本削减措施，以及2023年发生的临床试验和结转费用增加，部分抵消了与Human Immunology Biosciences, Inc.（HI-Bio）收购相关的2024年约4300万美元的股权激励费用。

•2024年第三季度与2023年第三季度相比，非通用会计减少约4800万美元，主要是由于公司在2024年实现的成本削减措施，与公司的研发重点和适合增长倡议有关，以及在2023年发生的临床试验支出和关闭成本增加。

•2024年第三季度相比2023年第三季度，GAAP SG&A费用下降约20000万美元，主要是由于2023年与Reata收购相关的大约19600万美元的股权补偿费用，以及2024年公司"适合增长"倡议所实现的成本削减措施。

•2024年第三季度与2023年第三季度相比，非通用会计原则SG&A费用约增加300万美元，主要是由于与新产品推出相关的商业化支出增加，部分抵消了公司「适合增长」方案带来的节省。

其他财务亮点

•2024年第三季度GAAP和非GAAP合作盈利分成净支出约为6900万美元，其中约6000万美元是与渤健公司的合作相关，另外约900万美元是与Sage Therapeutics, Inc. (Sage)合作以及在美国推广ZURZUVAE相关。

•2024年第三季度依美国通用会计准则计算的其他支出约为1500万美元，主要受净利息支出影响，部分被约3,900万美元的战略性股权投资的已实现和未实现收益所抵销。2024年第三季度依非美国通用会计准则计算的其他支出约为5400万美元，主要受净利息支出影响。

•2024年第三季度的依据通用会计准则和非通用会计准则有效税率分别为13.9%和13.8%。2023年第三季度的依据通用会计准则和非通用会计准则有效税率分别为51.6%和14.7%。

财务状况

•2024年第三季度来自营运的净现金流约为9.36亿美元。资本支出约为3.5亿美元，自由现金流定义为来自营运的净现金流减去资本支出，约为9.01亿美元。

•截至2024年9月30日，渤健公司现金、现金等价物和可市场出售证券总计约17亿美元，总债务约63亿美元，净债务约46亿美元。

•2024年第三季度公司并未回购任何普通股。截至2024年9月30日，自2020年10月核可的股份回购计划尚余约21亿美元。

•到2024年第三季，公司的稀释加权平均股份约为14600万。

2024年全年财务指引

截至2024年底，渤健公司现预期非通用会计损益收益每股收益指引区间如下：


	先前2024财年指引	2024财年指引已更新
非通用稀释每股收益	$15.75至$16.25 反映中位数增长约9%*	$16.10至$16.60 反映中位数增长约11%*

*Versus报告2023年全年业绩

渤健公司预计总营业收入将下降低位数百分比，核心药品营业收入，定义为产品收入加上渤健公司对乐信美比产品收入净额的50％份额，并包括成本和销售，包括版税，在2024年相较于2023年将维持相对平稳，因为预计多发性硬化产品收入进一步下滑将被新产品推出的收入增加所抵销。

渤健公司预期到2024年，在产品结构和显著降低闲置产能费用的推动下，销售成本占总营业收入的比例将较2023年有所改善。

相比2023年，渤健公司预计2024年营业收入将以高青少年百分比增长，营业利润率将提高中位数个百分点。这将由于销售成本占营收比例改善以及由于公司的增长适应和研发优先事项而导致营业费用降低。

这份财务指引并不包括任何潜在收购交易、业务发展交易、未了结和将来的诉讼，以及任何潜在税务或保健改革的影响，因为所有这些都难以预测。

本指引还假设截至2024年10月25日的汇率期货将保持效力至年底，扣除避险活动所致的影响。其他建模考量将在电话会议和网路直播中提供。

渤健公司可能于2024年承担费用、实现收益或亏损，或遇到其他事件或情况，可能导致这些假设发生变化，也可能使实际结果与财务指引产生差异。

渤健公司不提供GAAP报告财务指标（除了营业收入）或将前瞻性非GAAP财务指标调解至最直接可比的GAAP报告财务指标，因为公司无法预测项目如交易、整合和其他收购相关成本或庞大业务发展交易；飞凡收益和损失；潜在未来资产减值；股权安全投资的收益和损失；以及未来重大诉讼的最终结果，而毫不费力地预测这些项目。这些项目具有不确定性，取决于各种因素，并可能对预测期内的GAAP报告结果产生重大影响。出于同样的原因，公司无法处理不可用信息的重要性，这可能对未来的结果产生重要影响。

重要近期事件

•在十月，渤健公司和Sage决定不再将zuranolone作为治疗重度抑郁症的项目进行进一步开发。

业绩会及网路研讨会

该公司第三季度的业绩会将于2024年10月30日上午8:30通过互联网进行直播，可以通过渤健公司网站的投资者专栏www.biogen.com进行访问。幻灯片形式的补充信息也可在相同位置的互联网上访问，并将在网站上至少90天。

关于渤健公司

渤健公司成立于1978年，是一家领先的生物技术公司，致力于开拓创新科学，推出新药物，改变患者的生活，并为股东和社区创造价值。

We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

We routinely post information that may be important to investors on our website at

www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor

This press release contains forward-looking statements, relating to: our strategy and plans; potential of, and expectations for, our commercial business and pipeline programs; capital allocation and investment strategy; clinical development programs, clinical trials, and data readouts and presentations; regulatory discussions, submissions, filings, and approvals; the potential benefits, safety, and efficacy of our and our collaboration partners’ products and investigational therapies; the anticipated benefits and potential of investments, optimization of the cost structure including our "Fit for Growth" program, actions to improve risk profile and productivity of R&D pipeline, collaborations, and business development activities; our future financial and operating results; 2024 financial guidance. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “prospect,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our dependence on sales from our products; uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; failure to compete effectively; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks associated with current and potential future healthcare reforms; risks related to commercialization of biosimilars; failure to obtain, protect, and enforce our data, intellectual property, and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks relating to technology failures or breaches; problems with our manufacturing processes; risks relating to management, personnel and other organizational changes, including attracting and retaining personnel; failure to comply with legal and regulatory requirements; the risks of doing business internationally, including currency exchange rate fluctuations; risks relating to investment in our manufacturing capacity; risks relating to the distribution and sale by third parties of counterfeit or unfit versions of our products; risks relating to the use of social media and artificial

intelligence based software for our business; results of operations, and financial condition; fluctuations in our operating results; risks related to investment in properties; risks relating to access to capital and credit markets; risks related to indebtedness; the market, interest, and credit risks associated with our investment portfolio; risks relating to share repurchase programs; change in control provisions in certain of our collaboration agreements; fluctuations in our effective tax rate; environmental risks; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission.

These statements speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

###


媒体联系人：			投资者联系方式：
Biogen			Biogen
杰克·考克斯			Stephen Amato
电话：+1 781-464-3260			电话：+1 781-464-2442
public.affairs@biogen.com			IR@biogen.com

表格1

BIoGEN INC.和子公司

收入的产品净额

（未经审计，数额为百万，除每股金额外）


	截至9月30日三个月结束时,				截至9月30日的九个月
	2024		2023		2024		2023
营业收入：
产品净值	$	1,769.4	$	1,805.2	$	5,380.9	$	5,414.3

抗CD20治疗项目的营业收入	446.2		420.9		1,284.7		1,253.8
合同制造、特许权和其他收入	250.2		304.2		555.6		781.2
总收入	2,465.8		2,530.3		7,221.2		7,449.3
成本和费用：
销售成本，不包括收入摊销和取得的无形资产减值	638.7		659.6		1,726.9		1,915.1
研发	542.7		736.3		1,509.5		1,891.1
销售、一般及行政费用	588.4		788.2		1,723.7		1,941.2
已收购无形资产的摊销和减值	130.3		60.9		295.5		164.0
合作利润分享/（亏损补偿）	69.3		50.5		197.3		164.5
（增值 / 减值）公允价值重估的应计款项的（收益）损失	23.8		—		23.8		—

重组费用	6.8		76.0		24.9		120.0
优先审查凭证出售收益，净额	—		—		(88.6)		—
其他（收入）支出，净额	14.8		300.0		193.7		248.2
总成本及费用	2,014.8		2,671.5		5,606.7		6,444.1
税前利润（损失）	451.0		(141.2)		1,614.5		1,005.2
所得税（收益）费用	62.5		(72.9)		249.0		92.6

	388.5		(68.3)		1,365.5		912.6
归属于非控股权益的净利润（损失），扣除税后	—		(0.2)		—		1.2
归属于Biogen Inc.的净利润（损失）	$	388.5	$	(68.1)	$	1,365.5	$	911.4

净利润每份股息：
Biogen Inc.可归属每股基本收益（亏损）	$	2.67	$	(0.47)	$	9.38	$	6.30
Biogen Inc.可归属每股摊薄收益（亏损）	$	2.66	$	(0.47)	$	9.35	$	6.26

用于计算：
Biogen Inc.可归属每股基本收益（亏损）	145.7		144.8		145.5		144.7
Biogen Inc.可归属每股摊薄收益（亏损）	146.1		144.8		146.0		145.5

表2

BIoGEN INC.和子公司

简明合并资产负债表

（未经审计，单位：百万美元）


	截至2024年9月30日		截至2023年12月31日
资产
现金及现金等价物	$	1,699.2	$	1,049.9

2,687,823	1,536.2		1,664.1
来自抗CD20治疗项目的到期款项	451.9		435.9
库存	2,469.2		2,527.4
其他资产	674.0		1,182.0
总流动资产	6,830.5		6,859.3

物业、厂房和设备，净值	3,210.9		3,309.7
营业租赁资产	380.4		420.0
无形资产, 净额	9,805.5		8,363.0
商誉	6,485.8		6,219.2
递延税款资产	968.7		928.6
投资和其他资产	631.4		745.0
资产总计	$	28,313.2	$	26,844.8

负债和股东权益
应付票据和长期贷款的流动部分	$	1,748.1	$	150.0
应付税款	499.1		257.4
应付账款	422.7		403.3
应计费用和其他	2,755.1		2,623.6
当前负债合计	5,425.0		3,434.3
应付票据和长期贷款	4,545.8		6,788.2
递延所得税负债	882.4		641.8
长期经营租赁负债	357.0		400.0
其他长期负债	744.1		781.1
股权	16,358.9		14,799.4
负债和所有者权益总计	$	28,313.2	$	26,844.8

TABLE 3

BIOGEN INC. AND SUBSIDIARIES

PRODUCT REVENUE & TOTAL REVENUE

(unaudited, in millions)

Product Revenue


	For the Three Months Ended September 30,
	2024						2023
	United States		Rest of World		Total		United States		Rest of World		Total
Multiple Sclerosis (MS):
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: MS	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	$	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
	United States		Rest of World		Total		United States		Rest of World		Total
Multiple Sclerosis (MS):
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: MS	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
					0
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	$	2,405.8	$	2,975.1	$	5,380.9	$	2,293.3	$	3,121.0	$	5,414.3

(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.

Total Revenue


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Product revenue	$	1,769.4	$	1,805.2	$	5,380.9	$	5,414.3

OCREVUS royalties	346.8		319.1		985.8		928.2
RITUXAN/GAZYVA®/LUNSUMIO™ revenue	94.8		98.9		285.3		315.0
Other revenues from anti-CD20 programs	4.6		2.9		13.6		10.6
Contract manufacturing, royalty and other revenue	250.2		304.2		555.6		781.2
Total revenue	$	2,465.8	$	2,530.3	$	7,221.2	$	7,449.3

TABLE 4

BIOGEN INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION

OPERATING EXPENSE, OTHER (INCOME) EXPENSE, NET, AND INCOME TAX

(unaudited, in millions, except effective tax rate)

We supplement our GAAP consolidated financial statements and GAAP financial measures with other financial measures, such as adjusted net income, adjusted diluted earnings per share, revenue growth at constant currency, which excludes the impact of changes in foreign exchange rates and hedging gains or losses, and free cash flow, which is defined as net cash flow from operations less capital expenditures. We believe that these and other Non-GAAP financial measures provide additional insight into the ongoing economics of our business and reflect how we manage our business internally, set operational goals and form the basis of our management incentive programs. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Cost of Sales:
Total cost of sales, GAAP	$	638.7	$	659.6	$	1,726.9	$	1,915.1
Less: amortization of Reata inventory fair value step-up	46.1		—		130.6		—
Total cost of sales, Non-GAAP	$	592.6	$	659.6	$	1,596.3	$	1,915.1

Research and Development Expense:
Total research and development expense, GAAP	$	542.7	$	736.3	$	1,509.5	$	1,891.1
Less: amortization of Reata inventory fair value step-up	2.4		—		47.2		—
Less: acceleration of share-based compensation expense & related taxes A	42.5		197.0		42.5		197.0
Less: restructuring charges and other cost saving initiatives	6.4		0.2		19.6		0.7
Less: other	0.1		—		(1.4)		—
Total research and development expense, Non-GAAP	$	491.3	$	539.1	$	1,401.6	$	1,693.4

Selling, General and Administrative Expense:
Total selling, general and administrative, GAAP	$	588.4	$	788.2	$	1,723.7	$	1,941.2
Less: acceleration of share-based compensation expense & related taxes A	13.9		196.4		13.9		196.4
Less: acquisition-related transaction and integration costs	5.2		29.6		15.4		29.6
Less: restructuring charges and other cost saving initiatives	10.7		5.9		18.0		17.4
Less: other	2.5		3.3		9.4		8.4
Total selling, general and administrative, Non-GAAP	$	556.1	$	553.0	$	1,667.0	$	1,689.4

Amortization and Impairment of Acquired Intangible Assets:
Total amortization and impairment of acquired intangible assets, GAAP	$	130.3	$	60.9	$	295.5	$	164.0
Less: impairment charges	20.2		—		20.2		—
Less: amortization of acquired intangible assets	98.3		51.5		243.1		138.8
Total amortization and impairment of acquired intangible assets, Non-GAAP	$	11.8	$	9.4	$	32.2	$	25.2






Other (Income) Expense, net:
Total other (income) expense, net, GAAP	$	14.8	$	300.0	$	193.7	$	248.2
Less: (gain) loss on equity security investments	(39.1)		302.1		21.9		272.7
Less: (gain) loss on sale of equity interest in Samsung Bioepis and other investments	—		15.2		—		15.2

Less: other	—		9.0		0.3		9.0
Total other (income) expense, net, Non-GAAP	$	53.9	$	(26.3)	$	171.5	$	(48.7)

Income Tax (Benefit) Expense:
Total income tax (benefit) expense, GAAP	$	62.5	$	(72.9)	$	249.0	$	92.6

Less: income tax effect related to Non-GAAP reconciling items	(32.5)		(182.7)		(93.3)		(203.1)
Total income tax expense, Non-GAAP	$	95.0	$	109.8	$	342.3	$	295.7

TABLE 4 (continued)

BIOGEN INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION

NET INCOME ATTRIBUTABLE TO BIOGEN INC. & DILUTED EPS

(unaudited, in millions, except per share amounts)


	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2024			2023			2024			2023






Effective Tax Rate:
Total effective tax rate, GAAP	13.9		%	51.6		%	15.4		%	9.2		%
Less: impact of GAAP to Non-GAAP adjustments	0.1			36.9			0.1			(5.5)
Total effective tax rate, Non-GAAP	13.8		%	14.7		%	15.3		%	14.7		%












Net Income (loss) Attributable to Biogen Inc.:
Total net income (loss) attributable to Biogen Inc., GAAP	$	388.5		$	(68.1)		$	1,365.5		$	911.4
Plus: amortization of Reata inventory fair value step-up	48.5			—			177.8			—
Plus: impairment charges	20.2			—			20.2			—
Plus: acceleration of share-based compensation expense & related taxes A	56.4			393.4			56.4			393.4
Plus: acquisition-related transaction and integration costs	5.2			29.6			15.4			29.6
Plus: amortization of acquired intangible assets	98.3			51.5			243.1			138.8
Plus: restructuring charges and other cost saving initiatives	23.8			82.1			62.4			138.1
Plus: (gain) loss on fair value remeasurement of contingent consideration	23.8			—			23.8			—
Plus: (gain) loss on equity security investments	(39.1)			302.1			21.9			272.7

Plus: (gain) loss on sale of equity interest in Samsung Bioepis and other investments	—			15.2			—			15.2


Plus: income tax effect related to Non-GAAP reconciling items	(32.5)			(182.7)			(93.3)			(203.1)
Plus: other	2.6			12.4			8.3			17.4
Total net income (loss) attributable to Biogen Inc., Non-GAAP	$	595.7		$	635.5		$	1,901.5		$	1,713.5

Diluted Earnings Per Share:
Total diluted earnings (loss) per share, GAAP	$	2.66		$	(0.47)		$	9.35		$	6.26
(Less) Plus: adjustments to GAAP net income attributable to Biogen Inc. (as detailed above)	1.42			4.83			3.67			5.52
Total diluted earnings per share, Non-GAAP	$	4.08		$	4.36		$	13.02		$	11.78

A Share-based compensation expense reflects the accelerated vesting of awards previously granted to Human Immunology Biosciences, Inc. (HI-Bio) employees as a result of our acquisition of HI-Bio in the third quarter of 2024 as well as the accelerated vesting of awards previously granted to Reata Pharmaceuticals, Inc. (Reata) employees as a result of our acquisition of Reata in the third quarter of 2023. A portion of the total consideration to former HI-Bio and Reata employees were deemed to be compensation attributable to the post-acquisition service period and recognized as a charge to selling, general and administrative expense and to research and development expense within our consolidated statements of income.

TABLE 4 (continued)

BIOGEN INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION: REVENUE CHANGE AT CONSTANT CURRENCY

(unaudited)

Revenue changes at constant currency are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.


	Q3 2024 vs. Q3 2023		YTD 2024 vs. YTD 2023
Total Revenue:
Revenue change, as reported	(2.5)	%	(3.1)	%
Less: impact of foreign currency translation and hedging gains / losses	0.3		(0.1)
Revenue change at constant currency	(2.8)	%	(3.0)	%

Total Product Revenue:
Revenue change, as reported	(2.0)	%	(0.6)	%
Less: impact of foreign currency translation and hedging gains / losses	0.2		(0.3)
Revenue change at constant currency	(2.2)	%	(0.3)	%






Total MS Product Revenue:
Revenue change, as reported	(9.1)	%	(6.1)	%
Less: impact of foreign currency translation and hedging gains / losses	0.1		(0.1)
Revenue change at constant currency	(9.2)	%	(6.0)	%











Total Rare Disease Revenue
Revenue change, as reported	10.0	%	9.1	%
Less: impact of foreign currency translation and hedging gains / losses	0.1		(1.2)
Revenue change at constant currency	9.9	%	10.3	%











Total Biosimilars Product Revenue:
Revenue change, as reported	1.2	%	1.7	%
Less: impact of foreign currency translation and hedging gains / losses	1.0		0.5
Revenue change at constant currency	0.2	%	1.2	%

Total Revenue from Anti-CD20 Therapeutic Programs Revenue:
Revenue change, as reported	6.0	%	2.5	%
Less: impact of foreign currency translation and hedging gains / losses	—		0.1
Revenue change at constant currency	6.0	%	2.4	%

Total Contract Manufacturing, Royalty and Other Revenue:
Revenue change, as reported	(17.8)	%	(28.9)	%
Less: impact of foreign currency translation and hedging gains / losses	1.0		0.8
Revenue change at constant currency	(18.8)	%	(29.7)	%

TABLE 4 (continued)

BIOGEN INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION

FREE CASH FLOW

(unaudited, in millions)

We define free cash flow as net cash provided by (used in) operating activities in the period less capital expenditures made in the period. The following table reconciles net cash provided by (used in) operating activities, a GAAP measure, to free cash flow, a Non-GAAP measure.


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Cash Flow:
Net cash provided by (used in) operating activities	$	935.6	$	592.4	$	2,114.6	$	1,534.7
Net cash provided by (used in) investing activities	(1,181.1)		(1,742.2)		(780.6)		(3,448.7)
Net cash provided by (used in) financing activities	(6.6)		848.6		(691.4)		795.4
Net increase (decrease) in cash and cash equivalents	$	(252.1)	$	(301.2)	$	642.6	$	(1,118.6)

Net cash provided by (used in) operating activities	$	935.6	$	592.4	$	2,114.6	$	1,534.7
Less: Purchases of property, plant and equipment	35.0		74.2		114.4		211.8
Free cash flow	$	900.6	$	518.2	$	2,000.2	$	1,322.9

Use of Non-GAAP Financial Measures

Our “Non-GAAP net income attributable to Biogen Inc.” and “Non-GAAP earnings per share - Diluted” financial measures exclude the following items from “GAAP net income attributable to Biogen Inc.” and “GAAP earnings per share - Diluted”:

1. Acquisitions and divestitures

We exclude transaction, integration and certain other costs related to the acquisition and divestiture of businesses and items associated with the initial consolidation or deconsolidation of variable interest entities. These adjustments include, but are not limited to, the amortization and impairment of intangible assets, charges or credits from the fair value remeasurement of our contingent consideration obligations and losses on assets and liabilities held for sale.

2. Restructuring, business transformation and other cost saving initiatives

We exclude costs associated with our execution of certain strategies and initiatives to streamline operations, achieve targeted cost reductions, rationalize manufacturing facilities or refocus research and development activities. These costs may include employee separation costs, retention bonuses, facility closing and exit costs, asset impairment charges or additional depreciation when the expected useful life of certain assets have been shortened due to changes in anticipated usage and other costs or credits that management believes do not have a direct correlation to our ongoing or future business operations.

3. (Gain) loss on equity security investments

We exclude unrealized and realized gains and losses related to our equity security investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

4. Other items

We evaluate other items of income and expense on an individual basis and consider both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to our ongoing business operations and (iii) whether or not we expect it to occur as part of our normal business on a regular basis. We also include an adjustment to reflect the related tax effect of all reconciling items within our reconciliation of our GAAP to Non-GAAP net income attributable to Biogen Inc. and earnings per share - diluted.