Slide 1: Q4 and Full Year 2023 Financial Results and Business Update
Q4 and Full Year 2023 Financial Results and Business Update February 13, 2024
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: Q4 and full year 2023 earnings call agenda
Q4 and full year 2023 earnings call agenda Introduction Chuck Triano Head of Investor Relations Key Highlights Christopher A. Viehbacher President and Chief Executive Officer Development Update Priya Singhal, M.D., M.P.H. Head of Development Financial Update Michael McDonnell Chief Financial Officer
Slide 5: Key Highlights
Key Highlights Christopher A. Viehbacher President and Chief Executive Officer 5
Slide 6: Executing on the promise of a new Biogen
Executing on new potential growth drivers Executing on the promise • 4of a product new new Biogen launches ongoing in Alzheimer’s, FA, PPD and ALS Continued focus on maximizing profitability of existing Strong progress in ‘23 products sets up the potential for a • Stabilized key assets including SPI
Slide 7: Steady progress of the LEQEMBI launch
Steady progress of the LEQEMBI launch Biogen and Eisai have now launched LEQEMBI in Japan LEQEMBI now approved in China Continued demand and progress building out care pathways in the U.S. • ~2000 patients on therapy – ~150% increase from Q3 update* • 70% of Top 100 IDNs with positive P&T committee
Slide 8: Accelerating the SKYCLARYS launch with Biogen's global expertise in rare disease
Accelerating the SKYCLARYS launch with Biogen’s global expertise in rare disease Bolstering the SKYCLARYS launch in the U.S. with ~1000 patients now on therapy* Logistics Access Patient Support Engaging payers to ensure the Patient Services and Family Access Reduced the time from start appropriate p
Slide 9: ZURZUVAE launch is off to a promising start and raising awareness around PPD
ZURZUVAE launch is off to a promising start and raising awareness around PPD ZURZUVAE has received significant media attention following FDA approval and U.S. launch Featured in the New York 10 National broadcast Featured in TIME’s list of Times’ List of “Firsts” in features and over 5B “best invent
Slide 10: Development Update
Development Update Priya Singhal, M.D., M.P.H. Head of Development 10
Slide 11: Investing to fight against Alzheimer's on multiple fronts
Investing to fight against Alzheimer’s on multiple fronts Aim to expand our leadership through a diversified Alzheimer’s approach Amyloid Tau Additional AD Targets Working to support development of LEQEMBI in Early AD currently diagnostic tests and pathways to assess tau pathology in clinical trials
Slide 12: Potential to expand our rare disease portfolio with Angelman Syndrome
Potential to expand our rare disease portfolio with Angelman Syndrome Slow brain waves (Delta waves) are increased in AS Angelman Syndrome • Rare, genetic, neurodevelopmental disorder that occurs in one in 15,000 live births worldwide1 • Symptoms commonly appear between the age of 6-12 months1 Sidor
Slide 13: Aiming to build a specialized Immunology franchise in Lupus
Aiming to build a specialized Immunology franchise in Lupus Program Modality Indication Preclinical Phase 1 Phase 2 Phase 3 Dapirolizumab Pegol* Anti-CD40L mAb SLE Expected Readout Mid-year ’24# Litifilimab Anti-BDCA2 mAb SLE Litifilimab Anti-BDCA2 mAb CLE Designed as a Phase 2/3 Study Undisclosed S
Slide 14: 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 Expected Mid-year Readouts Lecanemab (Aβ mAb)* – AD Approved in U.S., Japan and China; Filed in the E.U and other geographies Alzheimer’s Disease Lecanemab (Aβ mAb)* – Preclinical AD BIIB105 # and Dementia
Slide 15: Financial Update
Financial Update Michael McDonnell Chief Financial Officer 15
Slide 16: Q4 and full year 2023 financial results
Q4 and full year 2023 financial results Total Revenue ($M) Q4* Full Year* (6%) at actual currency (3%) at actual currency (5%) at constant currency# (1%) at constant currency# $2,544 $10,173 $2,386 $9,836 2023 2022 2023 2022 * Beginning in the third quarter of 2023, we modified our presentation of t
Slide 17: Q4 and full year 2023 financial results
Q4 and full year 2023 financial results GAAP Diluted EPS ($) Non-GAAP Diluted EPS ($) Q4 Full Year Q4 Full Year (55%) (62%) (27%) (17%) $3.79 $20.87 $4.05 $17.67 $2.95 $14.72 $1.71 $7.97 2023 2022 2023 2022 2023 2022 2023 2022 Q4 2023 EPS negatively impacted by $0.35 due to previously disclosed clos
Slide 18: Multiple sclerosis product revenue
Multiple sclerosis product revenue MS Product Revenue ($M) Q4 2023 Highlights • TECFIDERA: Impacted by generic competition in Q4 Full Year the U.S. and certain markets outside the U.S. (8%) at actual currency (6%) at constant currency (14%) at actual currency (12%) at constant currency • The Europea
Slide 19: Rare disease revenue
Rare disease revenue Rare Disease Revenue ($M) Q4 2023 Highlights • U.S. SPINRAZA: Revenue was flat with higher Q4 Full Year demand offset by channel dynamics 3% at actual currency 1% at actual currency 6% at constant currency 4% at constant currency • ROW SPINRAZA: Revenue decreased 16% at $1,803 $
Slide 20: Biosimilars revenue
Biosimilars revenue Biosimilars Revenue ($M) Q4 2023 Highlights • Biosimilars: Benefited from volume growth Q4 Full Year partially offset by pricing pressure and 8% at actual currency 3% at actual currency 10% at constant currency 6% at constant currency competition $188 $770 $751 • Process to evalu
Slide 21: Q4 and full year 2023 revenue highlights
Q4 and full year 2023 revenue highlights Q4 2023 Q4 2022 D Y/Y D (CC#) FY 2023 FY 2022 D FY/FY D (CC#) $ in Millions Multiple sclerosis product revenue1 $1,168 $1,269 (8%) (6%) $4,662 $5,430 (14%) (12%) Rare disease revenue2 $472 $459 3% 6% $1,803 $1,794 1% 4% Biosimilars revenue $188 $175 8% 10% $7
Slide 22: Q4 and full year 2023 financial results summary
Q4 and full year 2023 financial results summary ($ in Millions except EPS, Shares in Millions) Q4 2023 Q4 2022 Δ Y/Y FY 2023 FY 2022 Δ FY/FY Revenue $2,386 $2,544 (6%) $9,836 $10,173 (3%) GAAP Cost of Sales $618 $571 (8%) $2,533 $2,278 (11%) % of revenue 26% 22% 26% 22% Non-GAAP Cost of Sales $587 $
Slide 23: Balance sheet and cash flow
Balance sheet and cash flow Balance Sheet Cash Flow (as of December 31, 2023) (Full Year 2023) $1.0B Cash and marketable securities $1.5B Net cash flow from operations* $6.9B Debt $277M Capital expenditures $5.9B Net debt $1.3B Free cash flow# * Includes a payment of approximately $393M for equity-b
Slide 24: Biogen full year 2024 financial guidance
Biogen full year 2024 financial guidance Full Year 2024 Guidance $15.00 to $16.00 Non-GAAP Diluted EPS Reflecting growth of ~5% at the mid-point* * Versus reported full year 2023 Please see Biogen’s Q4 and full year 2023 earnings release, available at the Investors section of Biogen’s website at inv
Slide 25: 2024 financial guidance key considerations
2024 financial guidance key considerations Total revenue is expected to decline by a low- to mid-single digit percentage in 2024 vs. 2023 Core pharmaceutical# revenue expected to be flat as increased revenue from new product launches to offset expected MS product revenue decline Contract manufacturi
Slide 26: 2024 financial guidance key considerations
2024 financial guidance key considerations Revenue mix and lower idle capacity charges expected to improve cost of sales as a percentage of revenue Operating income expected to grow at a low-double digit percentage vs. 2023 with expected mid-single digit percentage point operating margin expansion O
Slide 27: Closing
Closing Christopher A. Viehbacher President and Chief Executive Officer 27
Slide 28: Expected near-term milestones for 7 programs with potential to support long-term growth
Expected near-term milestones for 7 programs with potential to support long-term growth 2024 Expected Regulatory Decisions H1 H2 LEQEMBI in the E.U. SKYCLARYS in the E.U. QALSODY in the E.U. Expected Regulatory Submissions H1 H2 LEQEMBI subcutaneous formulation BLA LEQEMBI IV maintenance dosing sBLA
Slide 29: Questions & Answers
Questions & Answers 29
Slide 30: Appendix
Appendix 30
Slide 31: Consolidated Statement of Income
Consolidated Statement of Income (unaudited, in millions, except per share amounts) 31
Slide 32: Consolidated Balance Sheets
Consolidated Balance Sheets (unaudited, in millions) 32
Slide 33: Product Revenue (US and Rest of World) & Total Revenue
Product Revenue (US and Rest of World) & Total Revenue (unaudited, in millions) 33
Slide 34: 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 35: 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 35 included at the end of this presentation.
Slide 36: Notes to GAAP to Non-GAAP Reconciliation
Notes to GAAP to Non-GAAP Reconciliation A Share-based compensation expense reflects 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. We paid pay approximately $983.9 million in
Slide 37: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation Constant Currency & Free Cash Flow (unaudited, in millions) Revenue growth at constant currency vs. Q4 2022 and YTD 2022 Free cash flow 37