Slide 1: Second Quarter 2023 Financial Results and Business Update
Second Quarter 2023 Financial Results and Business Update July 25, 2023
Slide 2: Non-GAAP financial information
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 shar
Slide 3: Forward-looking statements
Forward-looking statements This presentation and the discussions during this conference call contain 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; clinica
Slide 4: Second quarter 2023 earnings call agenda
Second quarter 2023 earnings call agenda Introduction Chuck Triano Head of Investor Relations Key Highlights Christopher A. Viehbacher President and Chief Executive Officer Priya Singhal, M.D., M.P.H. R&D Update Head of Development Interim Head of Research Financial Update Michael McDonnell Chief Fi
Slide 5: Key Highlights
Key Highlights Christopher A. Viehbacher President and Chief Executive Officer 5
Slide 6: Delivering breakthrough treatment for people with Alzheimer's
Delivering breakthrough treatment for people with Alzheimer’s First anti-amyloid mAb with Observed differentiated Launch underway in Traditional Approval clinical profile the U.S. Efficacy observed across broad CMS confirmed broader Activities focused on physician Early AD population, including low
Slide 7: With "Fit for Growth", we are refocusing our efforts to support sustainable growth
With “Fit for Growth”, we are refocusing our efforts to support sustainable growth Where we were: Where we aim to be: • High operating expenses despite mature • Value-based decision making for existing product portfolio products • Over-investment in legacy products • Competitive investment in new pr
Slide 8: Reengineering of Biogen to better align cost with expected revenue
Reengineering of Biogen is expected to better align cost with expected revenue Expected Cost Savings by 2025# ~ $1 Billion Gross OPEX* Savings ~ $700 million Net OPEX* Savings Note: Estimated “Fit for Growth” savings are distinct from prior cost optimization initiatives 8 * OPEX = R&D expense + SG&A
Slide 9: R&D Update
R&D Update Priya Singhal, M.D., M.P.H. Head of Development Interim Head of Research 9
Slide 10: Continuing to generate data on LEQEMBI across early disease continuum
Continuing to generate data on LEQEMBI across early disease continuum Clarity AD Study Population Early AD Preclinical AD MCI Mild AD Subcutaneous formulation Phase 3 AHEAD 3 – 45 Trial New data from Clarity AD SC sub-study to Potential to delay or prevent onset of AD be presented at CTAD ‘23 Expect
Slide 11: New analysis presented at AAIC shows slower clinical decline in low tau PET subgroup
New analysis presented at AAIC shows slower clinical decline in low tau PET subgroup with LEQEMBI Source: Irizary, AAIC 2023 Note: LEQEMBI (lecanemab-irmb) is being developed in collaboration with Eisai Co.; Eisai serves as the lead for lecanemab development and regulatory submissions globally Data
Slide 12: Advancing a diversified Alzheimer's pipeline that spans molecular targets and modalities
Advancing a diversified Alzheimer’s pipeline that spans molecular targets and modalities Program Target Modality Preclinical Phase 1 Phase 2 Phase 3 Marketed ADUHELM Amyloid-β mAb (aducanumab) LEQEMBI Amyloid-β mAb (lecanemab)* BIIB080 Tau ASO small BIIB113 OGA molecule Undisclosed assets Amyloid-β
Slide 13: New data presented at CureSMA show improved motor function with SPINRAZA after Zolgensma
New data presented at CureSMA show improved motor function in participants treated with SPINRAZA after Zolgensma® Phase 4 RESPOND Study Open-label study evaluating SPINRAZA in participants who have previously received Zolgensma® and have suboptimal clinical status* Most participants had investigator
Slide 14: Aiming to enable growth by optimizing R&D value
Aiming to enable growth by optimizing R&D value Completed initial substantial R&D prioritization with aim to improve the risk profile and productivity of the R&D pipeline Programs to Watch BIIB080 in Litifilimab in BIIB105 in BIIB122 in BIIB121 in Early AD Lupus Broad ALS Early PD Angelman Syndrome
Slide 15: Advancing key late-stage assets with a reprioritized pipeline
Advancing key late-stage assets with a reprioritized pipeline Phase 1 Phase 2 Phase 3 Approved Lecanemab (Aβ mAb)* – Alzheimer’s Received Traditional Approval in U.S.; Filed for traditional approval in the E.U., Japan and other geographies Lecanemab (Aβ mAb)* – Preclinical Alzheimer’s Alzheimer’s Di
Slide 16: Financial Update
Financial Update Michael McDonnell Chief Financial Officer 16
Slide 17: Second quarter 2023 financial results
Second quarter 2023 financial results Q2 Total Revenue ($M) Q2 GAAP Diluted EPS ($) (5%) at actual currency (44%) (3%) at constant currency $7.24 $2,589 $2,456 $4.07 2023 2022 Q2 Non-GAAP Diluted EPS ($) (23%) $5.25 $4.02 2023 2022 2023 2022 Percentage changes in revenue growth at constant currency
Slide 18: Global multiple sclerosis product revenue
Global multiple sclerosis product revenue MS Product Revenue ($M) Q2 2023 Highlights Q2 • TECFIDERA was negatively impacted by generic competition in the U.S. and certain (15%) at actual currency (14%) at constant currency markets outside the U.S. • E.U. regulatory market protection extended $1,427
Slide 19: Global SPINRAZA revenue
Global SPINRAZA revenue SPINRAZA Revenue ($M) Q2 2023 Highlights Q2 • U.S. SPINRAZA: Revenue increased 12% with positive patient growth vs. prior year +1% at actual currency +5% at constant currency • ROW SPINRAZA: Revenue declined 3% at $437 actual currency and increased 1% at $431 constant currenc
Slide 20: Biosimilars revenue
Biosimilars revenue Biosimilars Revenue ($M) Q2 2023 Highlights Q2 • Biosimilars: Volume growth partially offset 0% at actual currency by continued pricing pressure for anti-TNFs +4% at constant currency in Europe $195 • BYOOVIZ (referencing LUCENTIS®) now $194 launched in U.S., Canada, Germany, U.K
Slide 21: Second quarter 2023 revenue highlights
Second quarter 2023 revenue highlights D (Constant ($ in Millions) Q2 2023 Q2 2022 D Y/Y Currency#) Multiple sclerosis product revenue1 $1,209 $1,427 (15%) (14%) Spinal muscular atrophy revenue2 $437 $431 1% 5% Alzheimer’s disease revenue3 ($20) $0 NMF NMF Biosimilars revenue $195 $194 0% 4% Other p
Slide 22: Second quarter 2023 financial results summary
Second quarter 2023 financial results summary Q2 2023 Q2 2022 Δ Y/Y ($ in Millions) Revenue $2,456 $2,589 (5%) GAAP and Non-GAAP Cost of Sales $593 $484 (22%) % of revenue 24% 19% GAAP and Non-GAAP R&D Expense $584 $529 (11%) GAAP SG&A Expense $548 $573 4% Non-GAAP SG&A Expense $534 $570 6% GAAP Amo
Slide 23: Expected impact of new "Fit for Growth" program
Expected impact of new “Fit for Growth” program Approximately $1 billion of Approximately $300 million gross OPEX* savings by 2025# of OPEX* reinvestment R&D portfolio prioritization Key R&D programs ~ $700M of net OPEX* Realign resources to areas of anticipated growth savings by 2025# Product launc
Slide 24: Balance sheet and cash flow
Balance sheet and cash flow Balance Sheet Cash Flow (as of June 30, 2023) (Q2 2023) $7.3B Cash and marketable securities $487M Net cash flow from operations $6.3B Debt $71M Capital expenditures $1.0B Cash position, net of debt $416M Free cash flow* 2424 Numbers may not foot due to rounding. * Free c
Slide 25: Reaffirming full year 2023 financial guidance
Reaffirming full year 2023 financial guidance Full Year 2023 Revenue Mid-single digit percentage decline* Non-GAAP Diluted EPS $15.00 to $16.00 * Versus reported revenue for full year 2022 Please see Biogen’s second quarter 2023 earnings release, available at the Investors section of Biogen’s websit
Slide 26: Closing
Closing Christopher A. Viehbacher President and Chief Executive Officer 26
Slide 27: Expected milestones with potential to support long-term growth
Expected milestones with potential to support long-term growth 2023 2024 Expected Regulatory Decisions Q3 Q4 Q1 LEQEMBI in Early Alzheimer’s disease • PMDA in Japan • EMA in E.U. • NMPA in China FDA PDUFA action date for zuranolone in the U.S. Expected Regulatory Submissions Q3 Q4 Q1 LEQEMBI subcuta
Slide 28: Questions & Answers
Questions & Answers 28
Slide 29: Appendix
Appendix 29
Slide 30: Consolidated Statement of Income
Consolidated Statement of Income (unaudited, in millions, except per share amounts) 30
Slide 31: Consolidated Balance Sheets
Consolidated Balance Sheets (unaudited, in millions) 31
Slide 32: Product Revenue (US and Rest of World) & Total Revenue
Product Revenue (US and Rest of World) & Total Revenue (unaudited, in millions) 32
Slide 33: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation Operating Expense, Other (Income) Expense, net and Income Tax (unaudited, in millions, except effective tax rate) Use of Non-GAAP Financial Measures We supplement our GAAP consolidated financial statements and GAAP financial measures with other financial measures, suc
Slide 34: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation Equity (Income)/Loss of Investee, Noncontrolling Interests, Net Income & Diluted EPS (unaudited, in millions, except per share amounts) Footnotes referenced in the tables above are 34 included at the end of this presentation.
Slide 35: Notes to GAAP to Non-GAAP Reconciliation
Notes to GAAP to Non-GAAP Reconciliation A In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics in exchange for total consideration of approximately $2.3 billion. Under the terms of this transaction, we received approximately $1.0 billion in cash a
Slide 36: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation Constant Currency & Free Cash Flow (unaudited, in millions) Revenue growth at constant currency vs. Q2 2022 and YTD 2022 Free cash flow 36