Slide 1: Second Quarter 2024 Financial Results and Business Update
Second Quarter 2024 Financial Results and Business Update August 1, 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: Biogen call participants
Biogen call participants Christopher A. Priya Singhal, Travis Murdoch, Michael Alisha A. Alaimo Viehbacher M.D., M.P.H. M.D. McDonnell President and Chief President and Head Head of Head of HI-Bio Chief Financial Executive Officer of North America Development Officer 4
Slide 5: Key Highlights
Key Highlights Christopher A. Viehbacher President and Chief Executive Officer 5
Slide 6: Working to deliver a New Biogen with progress across key aims
Working to deliver a New Biogen with progress across 3 key aims Build a strong late-stage Grow Product Revenue Improve the Margin Profile pipeline Position Biogen for future growth Stabilize the business Right-size the expense base through R&D productivity Q2 core pharmaceutical revenue Fit for Grow
Slide 7: Commercial Update
Commercial Update Alisha A. Alaimo President and Head of North America 7
Slide 8: LEQEMBI launch shows sustained momentum
LEQEMBI launch shows sustained momentum Sustained rate of new patient growth • Nearly 40% of all commercial patients on therapy added in Q2 Grew the number of prescribing physicians • Total prescribers increased by approximately 50% during Q2 Order volume accelerated at Priority 100 IDNs • Depth of
Slide 9: Advancing the global launch of SKYCLARYS
Advancing the global launch of SKYCLARYS SKYCLARYS now available in 12 markets outside the U.S. • Global launches delivered $100M in Q2 revenue U.S. continuing to exceed rare disease analogs • Deploying rare disease capabilities to focus on initiating new patients and community HCPs Europe and RoW l
Slide 10: ZURZUVAE launch exceeding expectations
ZURZUVAE launch exceeding expectations Growth across key launch metrics vs Q1 ‘24 • Revenue growth of 19% • Number of patients nearly doubled Continuous launch learnings informing next phase • OB-GYNs continue to account for the largest percentage of Rx • Higher than average aided awareness of ZURZ
Slide 11: Development Update
Development Update Priya Singhal, M.D., M.P.H. Head of Development 11
Slide 12: Biogen pipeline by therapeutic area and phase
Phase 1 Phase 2 Phase 3 Approved Lecanemab (Aβ mAb)* – Alzheimer’s Approved in U.S., Japan and China; Filed in other geographies Alzheimer’s Disease Lecanemab (Aβ mAb)* – Preclinical Alzheimer’s and Dementia BIIB080 (tau ASO)^ – Alzheimer’s BIIB113 (OGA inhibitor) – Alzheimer’s Dapirolizumab pegol (
Slide 13: 3-year data indicates the continued benefit of LEQEMBI
3-year data indicates the continued benefit of LEQEMBI Alzheimer’s does not stop after plaque removal and data shows continued clinical benefit with longer-treatment duration of LEQEMBI Early-start LEQEMBI showed expanded benefit at 36 Clinical data and biomarkers from Ph 2 show AD does months vs. n
Slide 14: Leading in Alzheimer's with the goal of expanding LEQEMBI treatment options
Leading in Alzheimer’s with the goal of expanding LEQEMBI treatment options for patients LEQEMBI IV Maintenance • sBLA filed with an expected FDA decision by January 2025 LEQEMBI SC AI – Maintenance • Received FDA Fast Track designation • Rolling submission initiated with expected completion in Q4’
Slide 15: 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 strategy Targeting tau as the potential next frontier in Alzheimer’s treatment • Advancing our investigational tau ASO (BIIB080), the first tau targeting asset to show reduction o
Slide 16: Key development events in 2024
Key development events in 2024 Rare Disease Immunology SKYCLARYS Pediatric Phase 1 dose-finding study Advanced Amethyst Phase 2/3 study of litifilimab in CLE to Phase 3 portion • Refining plans for a Phase 3 study to follow dose identification • First actively enrolling Phase 3 study in CLE and pote
Slide 17: Felzartamab Review
Felzartamab Review Travis Murdoch, M.D. Head of HI-Bio 17
Slide 18: Felzartamab is specific for CD38+ plasma cells
Felzartamab is specific for CD38+ plasma cells responsible for producing pathogenic antibodies Pathogenic auto- antibody production Unique MoA of felzartamab has the potential to deliver a non-chronic treatment option and differentiated safety profile in Felzartamab antibody-mediated Anti-CD20 disea
Slide 19: Felzartamab proof-of-concept across multiple rare immunology indications
Felzartamab has established proof-of-concept across multiple rare immunology indications with significant unmet need Antibody Mediated Primary Membranous Rejection IgA Nephropathy Nephropathy Leading cause of kidney The most prevalent glomerular Leading cause of nephrotic transplant loss with ~23k p
Slide 20: Felzartamab Phase 2 demonstrated unprecedented efficacy in AMR
Felzartamab Phase 2 demonstrated unprecedented efficacy in AMR Felzartamab treatment resulted in ~81% AMR resolution at week 24 vs. 20% for placebo At 52 weeks, 6 felzartamab-responders (6/9; 67%) maintained resolution of AMR TEAEs were mild to moderate in severity with no treatment discontinuations
Slide 21: Felzartamab durable effect on upstream biomarkers of IgAN
Felzartamab administration resulted in a durable effect on upstream biomarkers of IgAN Felzartamab 9-dose arm MoA selective for IgAN disease pathology Felzartamab directly depletes CD38+ plasma cells responsible for production of Gd-IgA1 and its auto-antibody Durable effect on IgAN disease biology 5
Slide 22: Felzartamab potential non-chronic treatment option in IgAN
Felzartamab has the potential to be a non-chronic treatment option in IgAN UPCR % Change from Baseline Interim Phase 2 Results Durable Efficacy out to 24 months Felzartamab demonstrated ~50% UPCR reduction at 24 months in the 9-dose group (>18 months off treatment) and durable stabilization of eGFR
Slide 23: Felzartamab effect on disease biomarkers and kidney function in PMN
Data showed felzartamab drives rapid, deep, and durable effect on disease biomarkers and kidney function in PMN Durable depletion of anti-PLA2R High unmet need for disease modifying agents Current SoC, including anti-CD20 agents, are insufficient with up to 40% of patients not achieving remission* O
Slide 24: Felzartamab as a potential first-in-class pipeline-in-a-product
Felzartamab represents a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product Potential Compelling Best-in-class Targeted Biology Clinical Data Broad Application Novel anti-CD38 targeting Proof of concept data Depletion of CD38+ Pipeline-in-product plasma cells prod
Slide 25: Financial Update
Financial Update Michael McDonnell Chief Financial Officer 25
Slide 26: Second quarter 2024 key financial highlights
Second quarter 2024 key financial highlights ✓ Second quarter 2024 total revenue $2.5 billion; GAAP diluted EPS of $4.00 and Non-GAAP diluted EPS of $5.28, both GAAP and Non-GAAP diluted EPS include a $0.52 per share benefit from the sale of one of Biogen’s two PRVs ✓ Total revenue was flat at actua
Slide 27: Second quarter 2024 revenue highlights
Second quarter 2024 revenue highlights Constant ($ in Millions) Q2 2024 Q2 2023 Y/Y Currency* Multiple sclerosis product revenue1 $1,150 $1,209 (5%) (5%) Total rare disease revenue2 $534 $438 22% 25% Biosimilars revenue $198 $195 2% 1% Other product revenue3 $18 $3 431% 441% Total product revenu
Slide 28: Second quarter 2024 financial results summary
Second quarter 2024 financial results summary ($ in Millions except EPS, Shares in Millions) Q2 2024 Q2 2023 Δ Y/Y Total Revenue $2,465 $2,456 0% GAAP Cost of Sales* $546 $593 8% % of revenue 22% 24% Non-GAAP Cost of Sales* $504 $593 15% % of revenue 20% 24% GAAP R&D Expense $514 $584 12% Non-GAAP R
Slide 29: Balance sheet and cash flow
Balance sheet and cash flow Balance Sheet Cash Flow (as of June 30, 2024) (Q2 2024) $1.9B* Cash and marketable securities $626M Net cash flow from operations $6.3B Debt $34M Capital expenditures $4.4B Net debt $592M Free cash flow# * In July 2024 Biogen utilized $1.15 billion of cash to acquire HI-B
Slide 30: Updated full year 2024 financial guidance
Updated full year 2024 financial guidance Prior FY 2024 Guidance Updated FY 2024 Guidance $15.00 to $16.00 $15.75 to $16.25 Non-GAAP Diluted EPS Reflecting growth of ~5% at the mid-point* Reflecting growth of ~9% at the mid-point* * Versus reported full year 2023 Please see Biogen’s Q2 2024 earnings
Slide 31: Full year 2024 guidance assumptions
Full year 2024 guidance assumptions* Total revenue now expected to decline by a low-single digit percentage Core pharmaceutical# revenue expected to be roughly flat as expected revenue from new product launches offsets expected MS revenue decline Contract manufacturing revenue expected to be signifi
Slide 32: Full year 2024 guidance assumptions (continued)
Full year 2024 guidance assumptions (continued)* Expect continued ramp in commercial spending for new product launches Expect additional operating expenditures (primarily R&D) in 2H 2024 of approximately $50 million related to the HI-Bio acquisition Continue to expect full year 2024 combined Non-GAA
Slide 33: Questions & Answers
Questions & Answers 33
Slide 34: Appendix
Appendix 34
Slide 35: Consolidated Statement of Income
Consolidated Statement of Income (unaudited, in millions, except per share amounts) 35
Slide 36: Consolidated Balance Sheets
Consolidated Balance Sheets (unaudited, in millions) 36
Slide 37: Product Revenue (US and Rest of World) & Total Revenue
Product Revenue (US and Rest of World) & Total Revenue (unaudited, in millions) 37
Slide 38: 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 39: GAAP to Non-GAAP Reconciliation: Net Income & Diluted EPS
GAAP to Non-GAAP Reconciliation Net Income & Diluted EPS (unaudited, in millions, except per share amounts) 39
Slide 40: GAAP to Non-GAAP Reconciliation: Revenue Change at Constant Currency
GAAP to Non-GAAP Reconciliation Revenue Change at Constant Currency vs Q2 2023 (unaudited, in millions) 40
Slide 41: GAAP to Non-GAAP Reconciliation: Free Cash Flow
GAAP to Non-GAAP Reconciliation Free Cash Flow (unaudited, in millions) 41