Slide 1: Third Quarter 2023 Financial Results and Business Update
Third Quarter 2023 Financial Results and Business Update November 8, 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: Third quarter 2023 earnings call agenda
Third quarter 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 Cl
Slide 5: Key Highlights
Key Highlights Christopher A. Viehbacher President and Chief Executive Officer 5
Slide 6: Executing on potential top and bottom-line growth drivers
Executing on potential top and bottom-line growth drivers Acquisition of Reata 3 recent FDA approvals and Reengineering the company Pharmaceuticals adds fourth ongoing/upcoming launches with Fit For Growth program launch opportunity LEQEMBI is the first anti-amyloid Acquisition adds a highly Refocus
Slide 7: Building momentum with the LEQEMBI launch
Building momentum with the LEQEMBI launch 60% approval and CMS reimbursement has FDA traditional driven increased patient utilization CMS removed the NCD for amyloid PET on October 13th Steady progress enabling patient access with ~60% of top 100 targeted IDNs now having P&T approval • Generating da
Slide 8: SKYCLARYS has the potential to benefit from Biogen's global expertise in rare disease
SKYCLARYS has the potential to benefit from Biogen’s global expertise in rare disease SKYCLARYS is the first therapy approved in FA in the U.S. offering a clinically meaningful advancement in the treatment of a debilitating disease U.S. launch underway with approximately $43 million in estimated sal
Slide 9: Development Update
Development Update Priya Singhal, M.D., M.P.H. Head of Development 9
Slide 10: Building on the distinct clinical profile of LEQEMBI with a new formulation and data
Building on the distinct clinical profile of LEQEMBI with a new formulation and data suggesting potential for greater benefit in earlier stage of disease Advancing subcutaneous LEQEMBI with encouraging results – Weekly subcutaneous lecanemab shows comparable PK and plaque reduction to biweekly IV fo
Slide 11: LEQEMBI-treated patients continued to benefit through 24 months
LEQEMBI-treated patients continued to benefit through 24 months Maintenance of treatment difference with ongoing lecanemab treatment through 24 months, relative to the newly treated lecanemab participants is consistent with a disease-modifying effect Source: Sperling, CTAD 2023 Post-hoc analysis; Ea
Slide 12: Tau-directed ASO (BIIB080) shows convergence of evidence
Tau-directed ASO (BIIB080) is the first tau targeting therapy to show convergence of evidence across soluble biomarkers, tau PET and exploratory clinical measures CDR-SB MMSE FAQ Favors BIIB080 Favors BIIB080 Favors BIIB080 Cohort D 115 mg Q12W → 115 mg Q12W (n=9) vs TANGO PSM (n=16) vs ADNI PSM (n=
Slide 13: Aiming to enable growth by optimizing the R&D portfolio
Aiming to enable growth by optimizing the R&D portfolio Advancing leadership and continued commitment in Alzheimer’s disease • Developing additional options for patients with LEQEMBI Planned submission for IV Planned submission for SC Potential indication expansion to maintenance therapy formulation
Slide 14: Financial Update
Financial Update Michael McDonnell Chief Financial Officer 14
Slide 15: Third quarter 2023 financial results
Third quarter 2023 financial results Q3 Total Revenue* ($M) Q3 GAAP Diluted EPS ($) +1% at actual currency (106%) +3% at constant currency# $7.84 $2,530 $2,508 ($0.47) 2023 2022 Q3 Non-GAAP Diluted EPS ($) (9%) $4.77 $4.36 2023 2022 2023 2022 * Beginning in the third quarter of 2023, we modified our
Slide 16: Global multiple sclerosis product revenue
Global multiple sclerosis product revenue MS Product Revenue ($M) Q3 2023 Highlights Q3 • TECFIDERA was negatively impacted by generic competition in the U.S. and certain (14%) at actual currency (12%) at constant currency markets outside the U.S. • Some generics have not yet fully exited $1,340 som
Slide 17: Global SPINRAZA revenue
Global SPINRAZA revenue SPINRAZA Revenue ($M) Q3 2023 Highlights Q3 • U.S. SPINRAZA: Revenue increased 7% with positive patient growth vs. prior year +4% at actual currency +7% at constant currency • ROW SPINRAZA: Revenue increased 2% at $448 actual currency and increased 7% at $431 constant currenc
Slide 18: Biosimilars revenue
Biosimilars revenue Biosimilars Revenue ($M) Q3 2023 Highlights Q3 • Biosimilars: Volume growth partially offset +4% at actual currency by pricing pressure and competition +7% at constant currency • TOFIDENCE (referencing ACTEMRA®): the $194 first tocilizumab biosimilar approved in the $188 United S
Slide 19: Third quarter 2023 revenue highlights
Third quarter 2023 revenue highlights D (Constant ($ in Millions) Q3 2023 Q3 2022 D Y/Y Currency#) Multiple sclerosis product revenue1 $1,159 $1,340 (14%) (12%) Spinal muscular atrophy revenue2 $448 $431 4% 7% Biosimilars revenue $194 $188 4% 7% Other product revenue3 $4 $3 25% 23% Total product rev
Slide 20: Third quarter 2023 financial results summary
Third quarter 2023 financial results summary ($ in Millions) Q3 2023 Q3 2022 Δ Y/Y Revenue $2,530 $2,508 1% GAAP and Non-GAAP Cost of Sales $660 $470 (40%) % of revenue 26% 19% GAAP R&D Expense $736 $549 (34%) Non-GAAP R&D Expense $539 $549 2% GAAP SG&A Expense* $788 $563 (40%) Non-GAAP SG&A Expense
Slide 21: Balance sheet and cash flow
Balance sheet and cash flow Balance Sheet Cash Flow (as of September 30, 2023) (Q3 2023) $2.3B Cash and marketable securities $592M Net cash flow from operations $7.3B Debt $74M Capital expenditures $5.0B Net debt $518M Free cash flow# # Free cash flow is defined as net cash flow from operations les
Slide 22: Updating full year 2023 financial guidance
Updating full year 2023 financial guidance Prior FY 2023 Guidance Updated FY 2023 Guidance Mid-single digit percentage Low-single digit percentage Revenue decline* decline* $14.50 to $15.00 Non-GAAP Diluted Reflecting ~$0.75 of dilution from Reata $15.00 to $16.00 EPS acquisition, which closed Septe
Slide 23: Fit for Growth update
“Fit for Growth” update Original Program Goals Updated Program Goals ~$1B gross savings No Change ~$1B gross savings by 2025 by 2025* ~$300M ~$200M reinvestment reinvestment Reflects Reata and = = ZURZUVAE net impact ~$700M net savings ~$800M net by 2025 savings by 2025* * Expected savings are based
Slide 24: Closing
Closing Christopher A. Viehbacher President and Chief Executive Officer 24
Slide 25: Expected near-term milestones for 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 Early Alzheimer’s disease • EMA in E.U. • NMPA in China SKYCLARYS in the E.U. QALSODY in the E.U. Expected Regulatory Submissions H1 H2 LEQEMBI subcutaneous for
Slide 26: Questions & Answers
Questions & Answers 26
Slide 27: Appendix
Appendix 27
Slide 28: 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)* – AD Approved in U.S. and Japan; Filed in the E.U., China, and other geographies Lecanemab (Aβ mAb)* – Preclinical AD Alzheimer’s Disease Aducanumab (Aβ mAb)* – AD Received Accelerated
Slide 29: Consolidated Statement of Income
Consolidated Statement of Income (unaudited, in millions, except per share amounts) 29
Slide 30: Consolidated Balance Sheets
Consolidated Balance Sheets (unaudited, in millions) 30
Slide 31: Product Revenue (US and Rest of World) & Total Revenue
Product Revenue (US and Rest of World) & Total Revenue (unaudited, in millions) 31
Slide 32: 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 33: 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 33 included at the end of this presentation.
Slide 34: 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 35: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation Constant Currency & Free Cash Flow (unaudited, in millions) Revenue growth at constant currency vs. Q3 2022 and YTD 2022 Free cash flow 35