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Biogen Q2 2025 Financial Results & Business Update
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2025-07-23
2025-09-22
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# SECOND QUARTER 2025 FINANCIAL RESULTS AND BUSINESS UPDATE # FORWARD-LOOKING STATEMENTS This presentation and the discussions during this conference call 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; and our 2025 financial guidance. These forward-looking statements may be accomp...
# SECOND QUARTER 2025 FINANCIAL RESULTS AND BUSINESS UPDATE
# FORWARD-LOOKING STATEMENTS
This presentation and the discussions during this conference call 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; and our 2025 financial guidance. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “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.
Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
This presentation and the discussions during this conference call include, among others, forward-looking statements including: our strategy to transform our product portfolio; expectations around the continued growth of our products;
the potential to expand and advance our late-stage product pipeline; the goal of creating sustainable growth and long-term value for shareholders; and all statements and information relating to our full year 2025 financial guidance.
These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forwardlooking statements will be realized in whole or in part.
We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, ncluding, among others, factors relating to: our substantial dependence on revenue from our products and other payments under licensing, collaboration, acquisition or divestiture agreements; uncertainty of long-term success in eveloping, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to ffectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the drivers for growing our business; difficulties in obtaining and maintaining adequate coverage, ricing, and reimbursement for our products; the drivers for growing our business, including 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, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; 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, including our incorporation of new technologies such as artificial intelligence into some of our processes; risks related to use of information technology systems and otential impacts of any breakdowns, interruptions, invasions, corruptions, data breaches, destructions and/or other cybersecurity incidents of our systems or those of connected and/or third-party systems; problems with our manufacturing capacity, including our ability to manufacture products efficiently or adequately address global bulk supply risks; risks relating to management, personnel and other organizational changes, including our ability to attracting, retaining and motivating qualified individuals; risks related to the failure to comply with current and new legal and regulatory requirements, including judicial decisions, accounting standards, and tariff or trade restrictions; the risks of oing business internationally, including geopolitical tensions, acts of war and large-scale crises; 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 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 to finance our present and future operations and business initiatives and obtain funding for such activities on favorable terms; 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 and obligations in various jurisdictions in which we re subject to taxation; 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 presentation and the discussions during this conference call and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10- K, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
# NON-GAAP FINANCIAL INFORMATION
This presentation and the discussions during this conference call include certain financial measures that were not prepared in accordance with accounting principles generally accepted in the U.S. (GAAP), including 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. Additional nformation regarding the GAAP and Non-GAAP financial measures and a reconciliation of the GAAP to Non-GAAP financial measures can be found in the appendix of this presentation and in the Q2 2025 earnings release and related financial tables posted on the Investors section of Biogen.com. 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.
We do not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because we are unable to predict with reasonable certainty the financial impact of items such as the transaction, ntegration, and other costs related to acquisitions or business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from our equity security investments; the ultimate outcome of litigation and other non-recurring items. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, we are unable to address the significance of the unavailable information, which could be material to future results.
Note regarding trademarks: ADUHELM®, AVONEX®, BYOOVIZ®, PLEGRIDY®, QALSODY®, RITUXAN®, RITUXAN HYCELA®, SKYCLARYS®, SPINRAZA®, TECFIDERA®, TYSABRI®, and VUMERITY® are registered trademarks of Biogen. BENEPALI , FLIXABI , FUMADERM , IMRALDI , and OPUVIZ are trademarks of Biogen. The following are trademarks of the respective companies listed: LEQEMBI® – Eisai Co., Ltd.; ZURZUVAE – Sage Therapeutics Inc.; COLUMVI®, GAZYVA®, LUNSUM $1 0 ^ { \\circledast }$ , OCREVUS® – Genentech, Inc. Other trademarks referenced in this presentation are the property of their respective owners.
# BIOGEN CALL PARTICIPANTS
Christopher A. Viehbacher
Priya Singhal, M.D., M.P.H.
Alisha A. Alaimo
Robin Kramer
President and Chief Executive Officer
Head of Development
President and Head of North America
Chief Financial Officer
# KEY HIGHLIGHTS
Christopher A. Viehbacher
President and Chief Executive Officer
# DURING Q2 WE CONTINUED TO DELIVER AGAINST OUR STRATEGYFOR LONG-TERM GROWTH
• Continued strength from new launches with revenue offsetting MS decline
• LEQEMBI showed sustained sequential growth with rising global demand
• SKYCLARYS now available in 29 markets1 globally and Phase 3 pediatric study underway
• ZURZUVAE revenue grew $68 %$ sequentially driven by increased demand; Received positive CHMP opinion in the E.U.
• Phase 3 studies initiated for felzartamab in IgAN and PMN and SKCLARYS in pediatric FA
• Positive Phase 1b results for salanersen supporting moving to registrational status and our potential long-term leadership in SMA
• New analyses of dapirolizumab pegol Phase 3 data in SLE show improvement in fatigue and reduction in disease activity
• Strategic research agreement with City Therapeutics aiming to develop novel RNAi-based therapies • Continued investment to support the pipeline and expand capabilities
# STRONG EXECUTION ACROSS AN EXPANDING PIPELINE INCLUDING MORE LATE-STAGE OPPORTUNITIES
\*Collaboration program; ^ Licensed from Ionis Pharmaceuticals, Inc. AD $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ Alzheimer’s disease; AMR $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ antibody mediated rejection; $\\mathsf { A S O } =$ antisense oligonucleotide; CLE $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ cutaneous lupus erythematosus; IgAN $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ IgA nephropathy; $\\mathsf { L N } =$ lupus nephritis; LRRK2 $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ leucine rich repeat kinase 2; MS $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ multiple sclerosis; $\\mathsf { M V } \| =$ microvascular inflammation in kidney transplant patients; PMN $\\mathbf { \\tau } = \\mathbf { \\tau }$ primary membranous nephropathy; $\\mathsf { S L E } = \\mathsf { S }$ ystemic lupus erythematosus; SMA $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ spinal muscular atrophy
# DEVELOPMENT UPDATE
Priya Singhal, M.D., M.P.H.
Head of Development
# FURTHER STRENGTHENED OUR PIPELINE IN Q2 TO SUPPORT OURLONG-TERM GROWTH OBJECTIVE
| | | | | |
| --- | --- | --- | --- | --- |
| Phase 1 | Phase 2 | Phase 3 | Regulatory Review in Certain Markets |
| (anti-CD38 mma) - LN | BIIBO8arlyau ASO)^ | Lecanc-Alini(taBt mAb)\* Early AD | (anticntamaAb) Late AMR | Lecanal maintBmAb)\* SC Early AD |
| | (LRK2Inm120 | Lecapemlini(cAB mAb)\* | (anti-CDamAb)- gAN | |
| BK In1ibitor - Ml | Danti-CD4u0Lab psLE | (anti-CDzamm)- PMN | (GABAPAME-PD |
| Felzartamab (anti-CD38 mAb) Late MVI Phase2 planned | Litifilimab (BDCA2 mAb) - SLE | SKYCLARYS (Nrf2 activator) - Pediatric FA | |
| | Litifilimab (BDCA2 mAb) - CLE | Zorevunersen (SCN1A ASO)\* - Dravet syndrome Phase 3 planned in 2025 | |
| | Salanersen (BlIB115) (SMN ASO)^ - SMA Phase 3 planned by early 2026 | | |
# Development Milestones:
ZURZUVAE: Positive CHMP opinion in the E.U.
SKYCLARYS: Initiated Phase 3 study in pediatric FA
Felzartamab: Phase 3 studies underway with new Phase 2 study planned in MVI Salanersen: Positive Phase 1b interim results
# nued scientific leadership with new data presentations at AAIC, EPNS, Cure SMA, EULAR and Lupus 2025
ipeline Updates: Added $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ Felzartamab Phase 2 planned in MVI; Advanced $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ Felzartamab programs in PMN and IgAN to Phase 3, SKYCLARYS in pediatric FA to Phase 3, Salanersen moved to registrational status; Discontinued $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ Izastobar complement mediated disease. \*Collaboration program; ^ Licensed from Ionis Pharmaceuticals, Inc.; ${ \\mathsf { A A l C } } =$ Alzheimer’s Association International Conference; $\\mathsf { A D } = .$ Alzheimer’s disease; ${ \\sf A M R } =$ antibody mediated rejection; ${ \\mathsf { A S O } } =$ ntisense oligonucleotide; ${ \\mathrm { C L E } } =$ cutaneous lupus erythematosus; $\\mathsf { F A } =$ Friedreich ataxia; EULAR $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ European Alliance of Associations for Rheumatology; EPNS $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ European Paediatric Neurology Society; $\\mathsf { G A B A } = \\mathsf { 1 }$ γ-Aminobutyric acid; HD $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ igher dose; ${ \\mathsf { I g A N } } = { \\mathsf { I g A } }$ nephropathy; $L N =$ lupus nephritis; LRRK2 $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ leucine rich repeat kinase 2; MS $\\mathbf { \\Sigma } = \\mathbf { \\Sigma }$ multiple sclerosis; $\\mathsf { M V } \| =$ microvascular inflammation in kidney transplant patients; $\\mathsf { P A M } =$ positive allosteric modulator; ${ \\mathsf { P D } } =$ arkinson’s disease; PMN $\\mathbf { \\tau } = \\mathbf { \\tau }$ primary membranous nephropathy; ${ \\mathsf { P P D } } =$ postpartum depression; ${ \\mathsf { S C } } - { \\mathsf { A l } } =$ subcutaneous autoinjector; ${ \\sf S L E } =$ systemic lupus erythematosus; SMA $\\mathbf { \\Psi } = \\mathbf { \\Psi }$ spinal muscular atrophy; SMN $\\mathbf { \\tau } = \\mathbf { \\tau }$ survival motor neuron
# WE RAN A PHASE 1B STUDY TO EVALUATE ONCE YEARLY SALANERSEN IN SMA PATIENTS WHO PREVIOUSLY RECEIVED GENE THERAPY
Salanersen is a novel ASO leveraging the same mechanism of action of SPINRAZA but designed for high potency to address the remaining unmet need in SMA
# Primary Endpoint
Safety (incidence of AEs / SAEs)
# Key Secondary Endpoint
• Pharmacokinetics (serum and CSF)
# Key Exploratory Endpoints
Neurofilaments
WHO motor milestones Motor function assessments • Older: HFMSE, RULM • Younger: HINE-2, CHOP-INTEND
# pants must have suboptimal clinical status in $\\geq 1$ of 4 domains as determined by study investigator at screening:
• Motor function • Respiratory function • Swallowing or feeding ability for age • Other
# INTERIM PHASE 1B RESULTS SUPPORT ADVANCEMENT TO PHASE 3 ANDHIGHLIGHT SALANERSEN’S POTENTIAL TO TRANSFORM SMA CARE
Data shows that salanersen resulted in substantial slowing of neurodegeneration and clinically meaningful improvements in children previously treated with gene therapy
# Interim Phase 1b results
Clinically meaningful improvements in motor function from baseline to 1-year on the HFMSE and the RULM scales $( \\mathsf { n } { = } 8 ) ^ { 1 }$ $70 %$ reduction in NfL at 6 months and sustained through 1-year $( n = 2 4 )$ 2 Cumulative Phase 1 data indicate that salanersen has a generally well tolerated safety profile
Case study examples\*
# Next Steps: Phase 3 study expected to start by early 2026
# NEW DATA HIGHLIGHTS THE POTENTIAL OF DAPIROLIZUMAB PEGOL TO ALLEVIATEFATIGUE, REDUCE DISEASE ACTIVITY AND IMPROVE QUALITY OF LIFE IN LUPUS
Dapirolizumab pegol showed efficacy across multiple clinical endpoints in the positive PHOENYCS GO Phase 3 study, including fatigue, measures of disease activity and patient reported outcomes
# New PHOENYCS GO data show that compared to SoC alone, DZP $\\dagger$ SoC resulted in:
Change in LupusQoL scores from baseline to Week 48
Improvements from baseline to week 48 in LupusQoL scores across all domains1 Improvements across multiple domains of fatigue measured by both FACIT and FATIGUE-PRO2 Measures of disease activity and remission, improved over time through 48 weeks of treatment3
Second confirmatory PHOENYCS FLY Phase 3 study ongoing
# OUR DISCIPLINED SCIENTIFIC APPROACH IS POISED TO DELIVERKEY EXPECTED MILESTONES OVER THE NEXT 18 MONTHS
4 Study Starts
4 Clinical Trial Readouts
3 Regulatory Decisions
Felzartamab Phase 3 in IgAN
Felzartamab Phase 3 in PMN
SKYCLARYS Phase 3 in pediatric FA Zorevunersen Phase 3 in DS\*
New
Salanersen Phase 3 in SMA Felzartamab randomized Phase 2 in Late MVI Potential new IND in immunology
# Salanersen Phase 1b interim in SMA
Litifilimab Phase 3 in SLE First Phase 3 by end of 2026
Litifilimab Phase 3 in CLE# Late 2026 to early 2027
BIIB080 Phase 2 in Early AD By mid-year 2026
Felzartamab Phase 1 in LN 2026
Zuranolone in PPD Positive CHMP opinion
LEQEMBI SC-AI maintenance in Early AD FDA PDUFA: August 31, 2025
LEQEMBI SC-AI initiation in Early AD Expected regulatory decision in H1 2026
Nusinersen (SPINRAZA) higher dose in SMA FDA PDUFA: September 22, 2025
# Biogen will host our next thematic seminar on September 3rd and will focus on our lupus pipeline
# COMMERCIAL UPDATE
Alisha A. Alaimo
President and Head of North America
# EXPANDING SKYCLARYS GLOBALLY TO REALIZE FULL POTENTIAL
See SKYCLARYS USPI for full prescriber information FA stands for Friedreich Ataxia; HCPs stands for health care professionals Actual paid patient
• Now available in $2 9 ^ { 1 }$ countries with Q2 worldwide sales of $$ 1$ 130 million, up $30 %$ YoY and $5 %$ QoQ
• U.S. seeing impact of focused investments on reaching community HCPs and slower progressing patients
o $\\sim 7 0 %$ of Q2 new U.S. patient starts from community prescribers o U.S. sales of $$ 78$ million, up $3 %$ YoY and $13 %$ QoQ
• SKYCLARYS is now included in treatment guidelines
# ZURZUVAE RAPIDLY GROWING AS A FIRST LINE THERAPY FOR PPD
See ZUZRUVAE USPI for full prescriber information PPD stands for Postpartum Depression Actual paid patient
ZURZUVAE (zuranolone) capsules@ For Postpartum Depression
• Q2 U.S. sales of $$ 46$ million, up 213% YoY and $6 8 %$ QoQ
• Field expansion driving performance across key metrics in Q2
o $2 9 %$ increase in prescribers in Q2 o $70 %$ of prescriptions from repeat prescribers o $80 %$ of prescriptions are for first line therapy1
# UNLOCKING NEW INVESTMENTS TO DRIVE LEQEMBI GROWTH WITH IMPORTANT OPPORTUNITIES AHEAD
See LEQEMBI USPI for full prescriber information Actual paid patient
LEQEMBI (lecanemab-irmb)
For Early Alzheimer's Disease
• Q2 worldwide sales of $$ 160$ million shows continued growth excluding the $$ 35$ million stocking in China; U.S. sales of $$ 63 M$ increased $20 %$ QoQ
U.S. prescriber base grew $34 %$ in first half of 2025; increased number of repeat prescribers
• Anti-amyloid therapy market growth estimated ${ \\sim } 1 5 %$ in Q21
Monthly PET increased 5x and blood-based biomarker testing nearly tripled in the last year2
DTC campaign and primary care pilot to support patient awareness and engagement
# FINANCIAL UPDATE
Robin Kramer
Chief Financial Officer
# SECOND QUARTER 2025 KEY FINANCIAL HIGHLIGHTS
# Total Revenue
GAAP Diluted EPS
Non-GAAP Diluted EPS
$2.65B 7% YoY
$4.33 8% YoY
$5.47 4% YoY
Launch Products\* Performance
$$ 2520$ $2 6 %$ QoQ and 91% YoY
• YoY increase in launch revenue offset YoY decline in MS product revenue
GAAP Operating Income
• $1 %$ YoY ( $6 %$ YoY excluding impact from acquired IPR&D charges)
Non-GAAP Operating Income
1% YoY ( $5 %$ YoY excluding impact from acquired IPR&D charges)
# Cash and Cashflow
• Generated $$ 1$ 134M of free cash flow - includes impact from $$ 745M$ of Q2 2025 tax payments • $$ 2.8 B$ of cash and $$ 3.5 B$ of net debt as of June 30, 2025
# Full Year 2025 Guidance Raised
• Expect FY 2025 Non-GAAP diluted EPS between $$ 15.50$ and $$ 16.00$ , up from between $$ 14.50$ and $$ 15.50$ previously
• Expect FY 2025 total revenue to be approximately flat, at constant currency, versus FY 2024, up from a mid-single digit decline previously
# SECOND QUARTER 2025 REVENUE HIGHLIGHTS
| | | | |
| --- | --- | --- | --- |
| ($ in Millions) | Q2 2025 Q2 2024 | △ YoY | △ CC\* |
| Multiple sclerosis product revenue1 | $1,107 $1,150 | (4%) | (4%) |
| Total rare disease revenue² | $543 $534 | 2% | 3% |
| Biosimilars revenue | $182 $198 | (8%) | (8%) |
| Other product revenue³ | $47 $18 | 169% | 170% |
| Revenue from anti-CD2O therapeutic programs | $467 | $445 5% | 5% |
| Alzheimer's collaboration revenue4 | $55 | $12 NMF | NMF |
| Contract manufacturing, royalty and other revenue | $245 | $109 124% | 119% |
| Total revenue | $2,646 | $2,465 7% | 8% |
$\\complement { \\mathsf { C } } =$ Constant Currency – Percentage changes in revenue growth 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. ${ \\mathsf { N M F } } =$ no meaningful figure; YoY $\\mathbf { \\tau } = \\mathbf { \\tau }$ year-over-year Note: Numbers may not foot due to rounding. Percent changes represented as favorable/(unfavorable). 1 includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA. Effective January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated. Biogen. 2 includes SPINRAZA, SKYCLARYS, and QALSODY. 3 includes ADUHELM, FUMADERM and ZURZUVAE. 4 includes Biogen’s $50 %$ share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
# SECOND QUARTER 2025 KEY P&L ITEMS
| | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ($ in Millions except EPS, Shares in Millions) | | Q2 2025Q22024△Y/Y | ($ in Millions except EPS,Shares in Millions) | Q2 2025 | Q2 2024△Y/Y | |
| | |
| Total Revenue | $2,646 $2,4657% | | | Total Revenue | $2,646 $2,4657% | | |
| GAAP Cost of Sales\* | $605 | $546 | (11%) | Non-GAAP Cost of Sales\* | $554 | $504 | (10%) |
| % of revenue | 23% | 22% | | % of revenue | 21% | 20% | |
| GAAP R&D Expense | $399 | $505 | 21% | Non-GAAP R&D Expense | $394 | $455 | 13% |
| GAAP SG&A Expense | $584 | $554 | (5%) | Non-GAAP SG&A Expense | $579 | $542 | (7%) |
| GAAP Acquired IPR&D, Upfront and Milestone | $47 | $9 | NMF | Non-GAP Acqired&DUpfrt | $47 | $9 | NMF |
| GAAP Operating Income | $795 | $784 | 1% | Non-GAAP Operating Income | $984 | $971 | 1% |
| GAAP Other (Income) Expense | $49 | $85 | 42% | Non-GAAP Other (Income) Expense | $57 | $55 | (4%) |
| GAAP Taxes % | 14.7% | 16.5% | | Non-GAAP Taxes % | 13.5% | 15.9% | |
| GAAP Net Income Attributable to Biogen Inc. | $635 | $584 | 9% | Non-GAAP Net Income Attributable to Biogen Inc. | $803 | $771 | 4% |
| Weighted Average Diluted Shares | 147 | 146 | (1%) | Weighted Average Diluted Shares | 147 | 146 | (1%) |
| GAAP Diluted EPS | $4.33 | $4.00 | 8% | Non-GAAP Diluted EPS | $5.47 | $5.28 | 4% |
| | | | | | | | |
| Approx. impact from acquired IPR&D | ($0.26) | | | Approx. impact from acquired IPR&D | ($0.26) | | |
\\* Excluding amortization and impairment of acquired intangible assets. The above table is not an income statement. Numbers do not foot. Percent changes represented as favorable/(unfavorable). Our GAAP financial measures and a reconciliation of GAAP to Non-GAAP financial results are at the end of this presentation.
# EXPECTED CASH FLOW SUPPORTS A BALANCE SHEET THAT ALLOWS FOR INVESTMENT TO AUGMENT GROWTH
Q2 2025 Cash Flow
# $161M
Cash flow from operations
Includes impact from $$ 745M$ of tax payments
# $27M
# Capital expenditures
# $134M
# Free cash flow\#
# OUR BUSINESS MODEL AND FOOTPRINT POSITIONS US FOR POTENTIAL RESILIENCE IN UNCERTAIN ENVIRONMENTS
# Significant U.S. Manufacturing Footprint
# Strong Geographic Diversification
# Revenue from Rare Disease
Diversified U.S. Payor Channel Mix
$\\sim 7 5 %$ of 2024 U.S. product revenue is attributable to products which are largely manufactured in the U.S.
$\\sim 5 5 %$ of 2024 product revenue attributable to sales outside the U.S.
${ \\sim } 3 1 %$ of 2024 core pharmaceutical revenue attributable to rare disease products
~60% commercial, ${ \\sim } 4 0 %$ government
# UPDATED GUIDANCE REFLECTS AN EXPECTED STRONGER BUSINESS OUTLOOK FOR FULL YEAR 2025
| | |
| --- | --- |
| | Full Year 2025 Non-GAAP Diluted EPS |
| Prior FY 2025 Guidance (May) | $14.50 to $15.50 |
| Benefit from stronger business outlook | +$0.87 |
| City Therax. imicst frsaction | ($0.12) |
| Updated FY 2025 Guidance | $15.50 to $16.00 |
Please see Biogen’s Q2 2025 earnings release, available at the Investors section of Biogen’s website at investors.biogen.com, for additional 2025 financial guidance assumptions.
This financial guidance incorporates the Company's view that Biogen's 2025 financial outlook is not currently expected to be materially impacted by potential pharmaceutical tariffs as announced by the U.S. Administration on April 2, 2025, even if the exemption for pharmaceuticals were to be removed. This is based on both a significant proportion of U.S. revenue being derived from products which have manufacturing operations in the United States, and the Company's current global inventory positions. The U.S. and international tariff landscape remains uncertain, and this guidance does not include contemplation of any new tariffs.
This financial guidance does not include any impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential tax or healthcare reform, as all are hard to predict. Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2025 that could cause any of these assumptions to change and/or actual results to vary from this financial guidance.
lease see slide 3 of this presentation for additional information on our use of Non-GAAP measures, including forward-looking Non-GAAP financial measures.
FY $\\mathbf { \\sigma } = \\mathbf { \\sigma }$ full year
# UPDATED KEY CONSIDERATIONS FOR FULL YEAR 2025 FINANCIAL GUIDANCE
# Total Revenue
Increased expected full year 2025 total revenue to be approximately flat, at constant currency, versus FY 2024, up from a mid-single digit decline previously
# MS Revenue
Excluding favorability from inventory and one-time GTN adjustments of $$ 75M$ , U.S. revenue trends for the second half of 2025 expected to be roughly in line with the first half Expect increased pace of erosion on our ex-U.S. MS business in the second half of 2025, particularly for TECFIDERA in the E.U.
# Contract Manufacturing Revenue
Expect FY 2025 contract manufacturing revenue to be roughly consistent with FY 2024 Expect minimal Q4 revenue due to planned plant maintenance
# Fit for Growth
On track to deliver $$ 10$ /gross and $800M/net savings from Fit for Growth by the end of 2025
# P&L
• In 2025, we plan to make additional investments in R&D to enable acceleration and expansion of the clinical development pipeline, primarily in support of rare disease – Expect FY 2025 OpEx to be ${ \\sim } $ 4.0 B$ Expect FY 2025 OIE to be a net expense of $170-180M
Identified $\\sim $ 15M$ of potential acquired IPR&D in 2H to-date Expect FY 2025 gross margin percentage and operating margin percentage to remain relatively flat versus FY 2024 excluding acquired IPR&D
# Tariffs/Macro
• FY 2025 not expected to be materially impacted by the potential tariffs as announced by the U.S. Administration on April 2, 2025, even if the exemption for pharmaceuticals were to be removed. Our guidance does not contemplate any new tariffs that may be announced in the future.
# QUESTIONS & ANSWERS
APPENDIX
# CONSOLIDATED STATEMENT OF INCOME
(unaudited,inmilions,exceptpershareamounts)
For the Three Months Ended For the Six Months Ended June 30, June 30,
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| 2025 | 2024 | | 2025 | 2024 |
| $ 1,878.7 | $ | 1,899.6 $ | 3,605.2 | $ 3,611.5 |
| 467.3 | | 444.5 | 845.5 | 838.5 |
| | 54.9 | 11.8 | 87.9 | 14.6 |
| | 244.6 | 109.0 | 537.9 | 290.8 |
| 2,645.5 | | 2,464.9 | 5,076.5 | 4,755.4 |
| | | | | |
| | 605.0 | 546.0 | 1,234.3 | 1,088.2 |
| | 399.0 | 505.4 | 833.1 | 950.8 |
| | 46.6 | 8.5 | 247.3 | 16.0 |
| | 583.8 | 553.8 | 1,156.3 | 1,135.3 |
| | 130.9 | 86.9 | 242.7 | 165.2 |
| | 75.0 | 62.4 | 133.1 | 128.0 |
| | 13.2 | 1 | 22.8 | 1 |
| | (0.7) | 6.6 | 34.6 | 18.1 |
| | 一 | (88.6) | 一 | (88.6) |
| | 48.7 | 85.2 | 117.1 | 178.9 |
| 1,901.5 | | 1,766.2 | 4,021.3 | 3,591.9 |
| | 744.0 | 698.7 | 1,055.2 | 1,163.5 |
| | 109.2 | 115.1 | 179.9 | 186.5 |
| $ | 634.8 $ | 583.6 | $ 875.3 | $ 977.0 |
| $ $ | 4.33 4.33 | $ 4.01 $ 4.00 | $ $ | 5.98 $ 5.97 $ | 6.72 6.70 |
| | | | | | |
| | 146.5 | 145.6 | | 146.3 | 145.4 |
| | 146.7 | 145.9 | | 146.7 | 145.9 |
Revenue: Product revenue,net Revenue from anti-CD20 therapeutic programs Alzheimer'scollaboration revenue Contract manufacturing, royalty and other revenue Total revenue
Cost and expense: Cost of sales, excluding amortization and impairment of acquired intangible assets Research and development Acquired in-process research and development, upfront and milestone expense Selling, general and administrative Amortizationand impairmentof acguired intangibleassets Collaboration profit sharing/(loss reimbursement) (Gain) loss on fair value remeasurement of contingent consideration Restructuring charges Gain on sale of priority review voucher, net Other (income) expense,net Total cost and expense
Income before income tax (benefit) expense
Income tax (benefit) expense
Net income attributable to Biogen Inc.
Net income per share: Basic earnings per share attributable to Biogen Inc. Diluted earnings per share attributable to Biogen Inc.
Weighted-average shares used in calculating: Basic earnings per share attributable to Biogen Inc. Diluted earnings per share attributable to Biogen Inc.
# CONSOLIDATED BALANCE SHEETS
(unaudited,inmilions)
# ASSETS
Cash and cash equivalents
Accounts receivable,net
Due from anti-CD20 therapeutic programs
Inventory
Other current assets Total current assets
Property, plant and equipment, net
Operating lease assets
Intangibleassets,net
Goodwill
Deferred taxasset
Investments and otherassets
TOTAL ASSETS
| | |
| --- | --- |
| As of June 30, 2025 | As of December 31,2024 |
| $ 2,758.8 | $ 2,375.0 |
| 1,624.2 | 1,404.8 |
| 459.8 | 464.0 |
| 2,274.3 | 2,460.5 |
| 850.6 7,967.7 | 752.5 |
| | 7,456.8 |
| 3,098.8 | |
| 334.5 | 3,181.3 |
| 9,467.5 | 356.4 |
| 6,493.1 | 9,691.2 |
| 330.9 | 6,478.9 |
| 637.7 | 324.2 |
| $ 28,330.2 | 560.5 $ 28,049.3 |
| | |
| $ 114.8 | $ 1,748.6 |
| 408.4 | 548.3 424.2 |
| 2,660.5 | |
| 3,183.7 | 2,807.7 |
| 6,283.7 | 5,528.8 |
| | 4,547.2 |
| 118.3 | 190.5 |
| 310.9 | 334.5 |
| 799.6 | 732.3 |
| 17,634.0 | 16,716.0 |
| | |
| $ 28,330.2 | $ 28,049.3 |
# LIABILITIES AND EQUITY
Current portion of notes payable
Taxes payable
Accounts payable
Accrued expenses and other Totalcurrentliabilities
Notes payable
Deferred tax liability
Long-term operating lease liabilities
Other long-term liabilities
Equity
TOTALLIABILITIES ANDEQUITY
# PRODUCT REVENUE (U.S. AND REST OF WORLD) & TOTAL REVENUE
(unaudited,inmilions)
Product Revenue
For the Three Months Ended June 30,
| | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | 2025 | 2024 |
| United States | Rest of World | Total | United States | Rest of World | Total |
| Multiple Sclerosis (MS): | | | | | | |
| TECFIDERA | 47.2 | 146.4 | 193.6 | 44.1 | 208.1 | 252.2 |
| VUMERITY | 188.0 | 24.3 | 212.3 | 144.2 | 21.6 | 165.8 |
| Total Fumarate | 235.2 | 170.7 | 405.9 | 188.3 | 229.7 | 418.0 |
| AVONEX | 121.7 | 56.0 | 177.7 | 117.2 | 65.6 | 182.8 |
| PLEGRIDY | 28.3 | 40.7 | 69.0 | 28.2 | 39.9 | 68.1 |
| Total Interferon | 150.0 | 96.7 | 246.7 | 145.4 | 105.5 | 250.9 |
| TYSABRI | 272.2 | 182.4 | 454.6 | 248.7 | 213.5 | 462.2 |
| FAMPYRA(1) | | | | | 18.7 | 18.7 |
| ubtotal: MS | 657.4 | 449.8 | 1,107.2 | 582.4 | 567.4 | 1,149.8 |
| are Disease: | | | | | | |
| SPINRAZA | 149.3 | 243.4 | 392.7 | 157.3 | 271.8 | 429.1 |
| SKYCLARYS(2) | 78.0 | 52.3 | 130.3 | 75.6 | 24.4 | 100.0 |
| QALSODY(3) | 7.5 | 12.5 | 20.0 | 4.6 | 0.4 | 5.0 |
| Subtotal: RareDisease | 234.8 | 308.2 | 543.0 | 237.5 | 296.6 | 534.1 |
| iosimilars: | | | | | | |
| BENEPALI | 一 | 112.1 | 112.1 | 1 | 117.3 | 117.3 |
| IMRALDI | | 46.7 | 46.7 | 一 | 53.2 | 53.2 |
| FLIXABI | | 14.3 | 14.3 | | 13.1 | 13.1 |
| BYOOVIZ | 2.5 | 6.1 | 8.6 | 10.3 | 3.4 | 13.7 |
| TOFIDENCE | | | | 0.8 | | 0.8 |
| Subtotal: Biosimilars | 2.5 | 179.2 | 181.7 | 11.1 | 187.0 | 198.1 |
| Other: | | | | | | |
| ZURZUVAE | 46.4 | | 46.4 | 14.9 | | 14.9 |
| Other(4) | | 0.4 | 0.4 | 0.8 | 1.9 | 2.7 |
| ubtotal: Other | 46.4 | 0.4 | 46.8 | 15.7 | 1.9 | 17.6 |
| Total product revenue, net | 941.1 | 937.6 | 1,878.7 | 846.7 | 1,052.9 | 1,899.6 |
(① Efective January1,225,ourcolaborationandlicenseagreement forFAMPYRA globalcommercializationights was terminated. (2 SKYCLARYS became commerciallyavailable in the E.U. during the first quarter of 2024. (3) QALSODY became commercially available in the E.U. during the second quarter of 2024. (4) Other includes FUMADERM and ADUHELM.
| | | | |
| --- | --- | --- | --- |
| For the Three Months Ended June 30, | For the Six Months Ended June 30, |
| 2025 | 2024 | 2025 | 2024 |
| $ 1,878.7 | $ 1,899.6 | $ 3,605.2 | $ 3,611.5 |
| 353.8 | 336.3 | 642.6 | 639.0 |
| 107.7 | 103.4 | 191.4 | 190.5 |
| 5.8 | 4.8 | 11.5 | 9.0 |
| 54.9 | 11.8 | 87.9 | 14.6 |
| 244.6 | 109.0 | 537.9 | 290.8 |
| $ 2,645.5 | $ 2,464.9 | $ 5,076.5 | $ 4,755.4 |
| | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | 2025 | 2024 |
| United States | Rest of World | Total | United States | Rest of World | Total |
| Multiple Sclerosis (MS): | | | | | | |
| TECFIDERA | 87.0 | 312.7 | 399.7 | 87.8 | 418.7 | 506.5 |
| VUMERITY | 305.1 | 46.0 | 351.1 | 250.1 | 43.2 | 293.3 |
| Total Fumarate | 392.1 | 358.7 | 750.8 | 337.9 | 461.9 | 799.8 |
| AVONEX | 230.3 | 114.2 | 344.5 | 228.4 | 132.9 | 361.3 |
| PLEGRIDY | 52.4 | 76.1 | 128.5 | 56.8 | 76.4 | 133.2 |
| Total Interferon | 282.7 | 190.3 | 473.0 | 285.2 | 209.3 | 494.5 |
| TYSABRI | 473.0 | 363.1 | 836.1 | 462.5 | 431.0 | 893.5 |
| FAMPYRA(1) | | 0.3 | 0.3 | | 37.9 | 37.9 |
| Subtotal: MS | 1,147.8 | 912.4 | 2,060.2 | 1,085.6 | 1,140.1 | 2,225.7 |
| Rare Disease: | | | | | | |
| SPINRAZA | 303.7 | 512.9 | 816.6 | 305.8 | 464.6 | 770.4 |
| SKYCLARYS(2) | 147.1 | 107.1 | 254.2 | 148.6 | 29.4 | 178.0 |
| QALSODY(3) | 15.0 | 20.5 | 35.5 | 9.0 | 0.6 | 9.6 |
| Subtotal: Rare Disease | 465.8 | 640.5 | 1,106.3 | 463.4 | 494.6 | 958.0 |
| Biosimilars: | | | | | | |
| BENEPALI | | 223.4 | 223.4 | 一 | 236.0 | 236.0 |
| IMRALDI | | 94.1 | 94.1 | 一 | 108.0 | 108.0 |
| FLIXABI | | 27.4 | 27.4 | 一 | 30.9 | 30.9 |
| BYOOVIZ | 6.7 | 10.8 | 17.5 | 14.0 | 5.3 | 19.3 |
| TOFIDENCE | 0.1 | | 0.1 | 0.8 | | 0.8 |
| Subtotal: Biosimilars | 6.8 | 355.7 | 362.5 | 14.8 | 380.2 | 395.0 |
| Other: | | | | | | |
| ZURZUVAE | 74.1 | 1 | 74.1 | 27.3 | 1 | 27.3 |
| Other(4) | 0.4 | 1.7 | 2.1 | 1.7 | 3.8 | 5.5 |
| Subtotal: Other | 74.5 | 1.7 | 76.2 | 29.0 | 3.8 | 32.8 |
| Total product revenue | 1,694.9 | 1,910.3 | 3,605.2 | 1,592.8 | 2,018.7 | 3,611.5 |
Total Revenue
# GAAP TO NON-GAAP RECONCILIATION
(unaudited,inmilions)
| | | | | |
| --- | --- | --- | --- | --- |
| | InreeMontnsEnded June 30, | FortneSix MontnsEnded June 30, |
| | 2025 | 2024 | 2025 | 2024 |
| Cost of Sales: | | | | |
| Total cost of sales, GAAP | 605.0 | 546.0 | $ 1,234.3 | 1,088.2 |
| Less: amortization of Reata inventory fair value step-up | 50.7 | 42.3 | 100.1 | 84.5 |
| Total cost of sales, Non-GAAP | 554.3 | 503.7 | $ 1,134.2 | 1,003.7 |
| Research and Development Expense^: | | | | |
| Total research and development expense, GAAP | 399.0 | 505.4 | 833.1 | 950.8 |
| Less: amortization of Reata inventory fair value step-up | | 44.8 | | 44.8 |
| Less: restructuring charges and other cost saving initiatives | 5.3 | 5.5 | 12.7 | 13.2 |
| Less: other | | | | (1.4) |
| Total research and development expense, Non-GAAP | 393.7 | 455.1 | 820.4 | 894.2 |
| Selling, General and Administrative Expense: | | | | |
| Total selling, general and administrative, GAAP | 583.8 | 553.8 | $ 1,156.3 | 1,135.3 |
| Less:acquisition-related transaction and integrationcosts | 2.1 | 6.0 | 4.1 | 10.2 |
| Less: restructuring charges and other cost saving initiatives | 2.5 | 3.7 | 0.3 | 7.3 |
| Less: other | 0.6 | 2.6 | 1.0 | 6.9 |
| Total selling, general and administrative, Non-GAAP | 578.6 | 541.5 | $ 1,150.9 | 1,110.9 |
| Amortization and Impairmentof Acquired Intangible Assets: | | | | |
| Total amortization and impairment of acquired intangible assets, GAAP | 130.9 | 86.9 | 242.7 | $ 165.2 |
| Less:impairment charges | 3.5 | | $ 3.5 | |
| Less: amortization of acquired intangible assets | 114.6 | 76.1 | 216.0 | 144.9 |
| Total amortization and impairment of acquired intangible assets, Non-GAAP | 12.8 | 10.8 | $ 23.2 | $ 20.3 |
| Other (Income) Expense, net: | | | | |
| Total other (income) expense,net, GAAP | 48.7 | 85.2 | $ 117.1 | $ |
| Less: (gain) loss on equity security investments | (5.3) | 30.3 | 30.3 | 178.9 61.0 |
| Less: other | (2.6) | 0.3 | (2.6) | 0.3 |
| Total other (income) expense, net, Non-GAAP | 56.6 | 54.6 | ＄ 89.4 | $ 117.6 |
| Income Tax (Benefit) Expense: | | | | |
| Total income tax (benefit) expense, GAAP | 109.2 | 115.1 | $ 179.9 | $ 186.5 |
| Less:income taxeffect related to Non-GAAP reconciling items | (16.2) | (30.9) | (52.3) | (60.8) |
| Total income tax (benefit) expense, Non-GAAP | | | ＄ 232.2 | $ |
| | 125.4 | 146.0 | | 247.3 |
# Use of Non-GAAP Financial Measures
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 change 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 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.
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/commercial assets and items associated with the initial consolidation or deconsolidation of variable interest entities. These adjustments include, but are not limited to, the amortization of inventory fair value step-up, 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/abandonment 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 on 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.
# GAAP TO NON-GAAP RECONCILIATION
Continued (unaudited,inmilions,exceptefectivetaxrates&pershareamounts)
For the Three Months Ended Forthe Six Months Ended June 30, June 30,
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| | Junes0, | Juneso, |
| | 2025 | 2024 | 2025 | 2024 |
| Effective Tax Rate: | | | | |
| Total effective tax rate, GAAP | 14.7 % | 16.5 % | 17.0 % | 16.0 % |
| Less: impact of GAAP to Non-GAAP adjustments | 1.2 | 0.6 | 1.3 | 0.1 |
| Total effective tax rate, Non-GAAP | 13.5 % | 15.9 % | 15.7 % | 15.9 % |
| Net Income Attributable to Biogen Inc.: | | | | |
| Total net income attributable to Biogen Inc., GAAP | 634.8 | 583.6 | 875.3 | 977.0 |
| Plus: amortization of Reata inventory fair value step-up | 50.7 | 87.0 | 100.1 | 129.3 |
| Plus: impairment charges | 3.5 | | 3.5 | |
| Plus: acquisition-related transaction and integration costs | 2.1 | 6.0 | 4.1 | 10.2 |
| Plus: amortization of acquired intangible assets | 114.6 | 76.1 | 216.0 | 144.9 |
| Plus: restructuring charges and other cost saving initiatives | 7.1 | 15.9 | 47.7 | 38.6 |
| Plus: (gain) loss on fair value remeasurement of contingent consideration | 13.2 | 一 | 22.8 | / |
| Plus: (gain) loss on equity security investments | (5.3) | 30.3 | 30.3 | 61.0 |
| Plus: income tax effect related to Non-GAAP reconciling items | (16.2) | (30.9) | (52.3) | (60.8) |
| Plus: other | (2.0) | 2.9 | (1.7) | 5.7 |
| Total net income attributable to Biogen Inc., Non-GAAP | 802.5 | 770.9 | $ 1,245.8 | $ 1,305.9 |
| Diluted Earnings Per Share: | | | | | |
| Total diluted earnings per share, GAAP (Less) Plus: adjustments to GAAP net income attributable to Biogen Inc. (as | 4.33 | 4.00 | $ 5.97 | $ | 6.70 |
| detailed above) | 1.14 | 1.28 | | 2.52 | 2.25 |
| Total diluted earnings per share, Non-GAAP | 5.47 | 5.28 | $ | 8.49 | 8.95 |
ADuring the first quarter of 2025 we began presenting acquired in-processresearch and development,upfront and milestone expenseas aseparateline item inour condensed consolidated statements of income.Acquired in-process research and development,upfrontand milestoneexpense includes costs incured inconnection withcollaborationandlicenseagreements such as upfront and milestone payments and,whenapplicable,premiums oneqitysecuritiesand asset acquisitions ofacquired in-processresearchanddevelopment,whichwerepreviously included inresearchanddevelopmentexpense.Priorperiods have beenreclassfiedtoconformtothecurrentperod presentation.Tereclasificationhadnoimpactonourtotalcostandexpense, net income attributable to Biogen Inc., earnings per share or total equity.
# GAAP TO NON-GAAP RECONCILIATION
Continued
RevenueChangeatConstantCurencyvsQ22024
(unaudited)
Revenue changes at constant currencyare 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.
| | | |
| --- | --- | --- |
| | Q2 2025 VS. Q2 2024 | YTD 2025 VS. YTD2024 |
| Total Revenue: | | |
| Revenue change,as reported | 7.3 % | 6.8 % |
| Less: impact of foreign currency translation and hedging gains/losses | (0.2) | (0.8) |
| Revenue change at constant currency | 7.5 % | 7.6 % |
| Total Product Revenue: | | |
| Revenue change,as reported | (1.1)% | (0.2)% |
| Less: impact of foreign currency translation and hedging gains /losses | (0.3) | (1.0) |
| Revenue change at constant currency | (0.8)% | 0.8 % |
| Total MS Product Revenue: | | |
| Revenue change,as reported | (3.7)% | (7.4)% |
| Less: impact of foreign currency translation and hedging gains /losses | 0.2 | (0.4) |
| Revenue change at constant currency | (3.9)% | (7.0)% |
| Total Rare Disease Revenue | | |
| Revenue change,as reported | 1.7 % | 15.5 % |
| Less: impact of foreign currency translation and hedging gains /losses | (1.1) | (1.8) |
| Revenue change at constant currency | 2.8 % | 17.3 % |
| Total Biosimilars Product Revenue: | | |
| Revenue change,as reported | (8.3)% | (8.2)% |
| Less: impact of foreign currency translation and hedging gains /losses | (0.7) | (2.0) |
| Revenue change at constant currency | (7.6)% | (6.2)% |
| Total Other Product Revenue: | | |
| Revenue change,as reported | 169.5 % | 132.7 % |
| Less: impact of foreign currency translation and hedging gains/losses | (0.9) | |
| Revenue change at constant currency | 170.4 % | (1.0)% 133.7 % |
| Total Revenue from Anti-CD2O Therapeutic Programs Revenue: | | |
| Revenue change,as reported | 5.1 % | 0.8 % |
| Less: impact of foreign currency translation and hedging gains/losses | | |
| Revenue change at constant currency | 5.1% | 0.8 % |
| Total Contract Manufacturing, Royalty and Other Revenue: | | |
| Revenue change,as reported | 124.4 % | |
| Less: impact of foreign currency translation and hedging gains / losses | | 85.0 % |
| | 5.2 | 1.0 |
| Revenue change at constant currency | 119.2 % | 84.0 % |
# GAAP TO NON-GAAP RECONCILIATION
Continued Fre CashFlow (unaudited,inmilions)
We define free cash flowas 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.
Forthe Three Months Ended June 30,
Forthe Six Months Ended June 30,
| | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| 2025 | 2024 | 2025 | | 2024 |
| $ | 160.9 | $ 625.8 | $ | 420.2 | $ 1,179.0 |
| (57.0) | 466.5 | (104.3) | 400.5 |
| (11.7) | (245.2) | (34.7) | (684.8) |
| $ | 92.2 | $ 847.1 | $ | 281.2 | $ | 894.7 |
| $ | 160.9 | $ 625.8 | $ | 420.2 | $ | 1,179.0 |
| 26.6 | 33.5 | | 63.7 | 79.4 |
| 134.3 | $ 592.3 | $ 356.5 | $ | 1,099.6 |
| |
| --- |
| Cash Flow: |
| Net cash providedby (used in) operating activities |
| Net cash provided by (used in) investing activities |
| Net cash provided by (used in) financing activities |
| Net increase (decrease) in cash and cash equivalents |
| |
| Net cash provided by (used in) operating activities |
| Less: Purchases of property, plant and equipment |
| Free cash flow |
# LEQEMBI COLLABORATION ACCOUNTING
Revenue (Commercial)
• Eisai records $100 %$ of net product revenue globally
• Biogen’s $50 %$ share of LEQEMBI revenue, net and cost of sales (including royalties) is recorded in “Alzheimer's collaboration revenue”
Revenue (Manufacturing)
• Biogen manufactures LEQEMBI drug substance
• Biogen sells drug substance to Eisai and recognizes contract manufacturing revenue and contract manufacturing cost of sales
# Expenses
• Biogen’s $50 %$ share of R&D and SG&A expenditures are reflected within Biogen’s R&D expense and SG&A expense, respectively
# ZURZUVAE COLLABORATION ACCOUNTING
Commercial Economics (U.S.)
• Biogen reflects net revenue on sales of ZURZUVAE and records Biogen’s cost of sales and SG&A in their respective line items. Biogen shares $50 %$ of the profit or loss with Sage, which is recognized in the “collaboration profit sharing/(loss reimbursement)” line on the P&L
# R&D Expense
• Biogen’s $50 %$ share of R&D expenditures are reflected within R&D expense
Ex-U.S.
• Outside of the U.S., Biogen is responsible for development and commercialization, excluding Japan, Taiwan and South Korea, and may pay Sage potential tiered royalties in the high-teens to low-twenties
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