Roche Holding Ltd · SIX:RO
Roche — Q1 2025 Earnings Presentation
56 slides from Roche's earnings presentation, Apr 24, 2025
Slide 1: Slide 1
Slide 2: Forward-looking statements
This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, str
Slide 3: Roche Q1 2025 sales
Roche Q1 2025 sales Basel, 24 April 2025
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: Performance Outlook
Performance Outlook
Slide 6: Q1 2025: Group sales growth at +6%
Q1 2025: Group sales growth at +6% Q1 sales all at CER ▪ Group sales growth +6%, +8% Pharma and 0% for Diagnostics (healthcare pricing reforms in China) ▪ LOE impact in line with guidance Key milestones achieved in Q1 ▪ Pharma regulatory: EU approval Columvi in 2L+ DLBCL, US approval Susvimo in DME
Slide 7: Q1 2025: Strong Pharma sales driving Group growth
Q1 2025: Strong Pharma sales driving Group growth Diagnostics impacted by healthcare pricing reforms in China Q1 2025 Q1 2024 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 11.9 10.9 9 8 Diagnostics Division 3.5 3.5 0 0 Roche Group 15.4 14.4 7 6 CER: Constant Exchange Rates (avg full year
Slide 8: Q1 2025: Consistent strong growth in the last four quarters
Q1 2025: Consistent strong growth in the last four quarters Group sales growth %CER +15% China Diagnostics healthcare pricing reforms +10% +9% +9% +9% +9% +6% +5% +2% +2% +1% +1% 0% COVID-19 pandemic Pandemic phase out Post-pandemic Base business: +1%* Base business: +8%* Business growth: +8%* -5% 2
Slide 9: Key growth drivers of the Roche portfolio
Key growth drivers of the Roche portfolio Diagnostics: Molecular Lab and Q1 2025 sales Pathology Lab driving growth; China 0% (CHFbn, YoY CER growth) impacted by healthcare pricing reforms Phesgo: Conversion rate climbing to 47% 3.5 Alecensa: Geographic expansion in adj. ALK+ NSCLC 6.0 +6% 0.9 CHF 1
Slide 10: Young portfolio to drive growth in the near- to mid-term
Young portfolio to drive growth in the near- to mid-term 4 key pivotal NME readouts expected in 2025 CHFbn % of Pharma Sales2 8.0 59% 7.0 50% 55% 6.0 5.0 42% 4.0 1 3.0 2.0 1.0 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 0.0 Q1 2022 Q1 2023 Q1 2024 Q1 2025 Pivotal NME readouts • astegolima
Slide 11: Roche with full Pharma and Diagnostics value chains in the US
Roche with full Pharma and Diagnostics value chains in the US Commitment to invest USD 50bn into R&D and PP&E in the US until the end of the decade 13+1* manufacturing and 15+1* R&D sites in the US Biologics productivity evolution 2000 to 2030 ▪ US investments of USD 67bn over the last 10 years, inc
Slide 12: Performance Outlook
Performance Outlook
Slide 13: Roche Sequencing Solution
Roche Sequencing Solution1 Combination of two powerful innovations creates a leap forward in sequencing Presented at AGBT High-throughput sensor module SBX chemistry Unique benefits + = ▪ 8 million microwell array CMOS chip ▪ Novel chemistry from Stratos turns DNA ▪ Accuracy: High accuracy, fit for
Slide 14: Roche's commitment to become a leader in CVRM
Roche’s commitment to become a leader in CVRM Complementing our obesity portfolio and laying the foundation for future innovation in CVRM Pharmaceuticals Diagnostics * ** CT-173 (PYY) CT-388 (GLP-1/GIP RA) CT-868 (GLP-1/GIP RA) CT-996 (GLP-1 RA) Petrelintide (Long-acting amylin analogue) GYM 329 (an
Slide 15: 2025 Pharma pipeline
2025 Pharma pipeline Q1 key updates: Ph III Go for trontinemab in AD and for NXT007 in hemophilia A; Zealand Pharma collaboration New Molecular Entities (NME) giredestrant fenebrutinib vamikibart HR+ BC RMS, PPMS DME, UME Itovebi (inavolisib) Elevidys1 CT-388 Pi3Km BC DMD Obesity +/- T2D divarasib G
Slide 16: 2025 guidance
2025 guidance LOE impact of CHF 1.2bn expected for 2025 Group sales growth1 Mid single digit sales growth Core EPS growth1 High single digit Core EPS growth Dividend outlook Further increase dividend in Swiss francs 1. At CER: Constant Exchange Rates (avg full year 2024); LOE: Loss of exclusivity in
Slide 17: Finance
Finance Alan Hippe Chief Financial Officer
Slide 18: Q1 2025: Group growth at +6%
Q1 2025: Group growth at +6% Pharma Division driving growth, Diagnostics Division stable due to healthcare pricing reforms in China +6% at CER CHFm +1,141 +117 -222 +141 -136 15,440 14,399 2024 China Dia Pharma LOE Fx 2025 healthcare pricing (excl. China) (excl. LOE) reforms CER: Constant Exchange R
Slide 19: Exchange rate impact on sales growth
Exchange rate impact on sales growth Positive impact driven by the USD -0.6%p 1.5%p 0.0%p -0.1%p 0.1%p -0.1%p CER CHF sales growth sales growth 2025 2025 vs. +7.2% vs. 2024 +6.4% 2024 CER EUR APAC USD LATAM JPY Other CHF CER: Constant Exchange Rates (avg. full year 2024) 19
Slide 20: Expected 2025 currency impact
Expected 2025 currency impact FY 2025 impact of -5%p on Group sales expected assuming 23 Apr 2025 rates remain stable until the end of 2025 USD / CHF Assumed avg. YTD 2025 +3% 0% +1% +1% Assuming the 31 March 2025 exchange rates remain stable until end of 2025, 0.90 0.89 0.89 0.89 2025 impact1 is ex
Slide 21: 2025 guidance
2025 guidance LOE impact of CHF 1.2bn expected for 2025 Group sales growth1 Mid single digit sales growth Core EPS growth1 High single digit Core EPS growth Dividend outlook Further increase dividend in Swiss francs 1. At CER: Constant Exchange Rates (avg. full year 2024); LOE: Loss of exclusivity i
Slide 22: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 23: Q1 2025: Pharmaceuticals sales
Q1 2025: Pharmaceuticals sales Continued strong growth in US, EU and International; Japan returning to growth Q1 2025 Q1 2024 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 11,949 10,921 9 8 United States 6,224 5,692 9 6 Europe 2,320 2,200 5 5 Japan 671 649 3 3 International 2,734 2,380 15 1
Slide 24: Q1 2025: Young portfolio delivering strong growth
Q1 2025: Young portfolio delivering strong growth Growth across all regions with strong performance in International Phesgo 52% Vabysmo 18% Xolair 26% Hemlibra 11% Xofluza 234% Polivy 42% Ocrevus 6% Evrysdi 18% Elevidys >500% Alecensa 11% Columvi 138% Gazyva 15% Enspryng 27% Lunsumio 25% Tecentriq 0
Slide 25: Oncology growing +2% in Q1 driven by HER2 franchise
Oncology/Hematology Oncology growing +2% in Q1 driven by HER2 franchise Phesgo conversion rate climbing to 47% in 58 launch countries* Q1 update Itovebi Avastin CHF 14m / N/A ▪ Phesgo: Strong uptake across all regions; strong growth in China CHF 274m / -15% Others following NRDL listing Herceptin CH
Slide 26: Polivy with strong global growth driven by 1L DLBCL
Oncology/Hematology Polivy with strong global growth driven by 1L DLBCL Positive Lunsumio Ph III (SUNMO) results in 2L+ DLBCL; Columvi EU approval achieved in 2L+ DLBCL Q1 update Lunsumio Columvi CHF 21m / +25% ▪ Hemlibra: Strong Q1 growth across all patient segments; US CHF 60m / +138% PiaSky impac
Slide 27: NXT007: Next-gen Factor VIIIa mimetic bispecific mAb
Oncology/Hematology NXT007: Next-gen Factor VIIIa mimetic bispecific mAb Ph II data to be presented in 2025; Ph III program, including H2H vs. Hemlibra, to initiate in 2026 NXT007 (FVIIIa mimetic bispecific mAb) Clinical development Structure and function1 NXT007, Hemlibra and FVIII thrombin generat
Slide 28: Ocrevus Zunovo permanent J-Code granted on April 1st
Neurology Ocrevus Zunovo permanent J-Code granted on April 1st Achieved US approval for Evrysdi tablet formulation Q1 update Elevidys ▪ Ocrevus: ~50% Zunovo US starts naïve to Ocrevus CHF 43m / + * Others CHF 91m / -7% ▪ Evrysdi: US approval for tablet formulation achieved; 5-year Enspryng CHF 83m /
Slide 29: Trontinemab: Rapid and deep amyloid clearance in AD
Neurology Trontinemab: Rapid and deep amyloid clearance in AD 81% of patients on 3.6 mg/kg dose achieved amyloid PET negative within 28 weeks Trontinemab (Brainshuttle Ph I/IIb (BrainshuttleTM-AD): Updated results1 bispecific 2+1 anti-Aβ mAb) Efficacy (Amyloid clearance) Safety (ARIA) Blood BBB Brai
Slide 30: Prasinezumab: Delay of confirmed motor progression in PD
Neurology Prasinezumab: Delay of confirmed motor progression in PD Additional OLE data and decision on next steps around mid-year Prasinezumab (α-synuclein Ab) Ph IIb (PADOVA) results3 Time to ≥5 points on MDS-UPDRS Part III OFF (L-DOPA population, n=435) 100 HR (95% CI)=0.79 (0.63, 0.99) Prasinezum
Slide 31: Xolair with strong launch uptake in food allergy
Immunology Xolair with strong launch uptake in food allergy Three afimkibart (anti-TL1A) trials initiated: Ph III in Crohn’s disease, Ph II in atopic dermatitis and Ph I in MASH Q1 update ▪ Xolair: Strong food allergy launch with >50k patients on treatment Others CHF 234m / +1% Actemra ▪ Updated Ph
Slide 32: Gazyva: Ph III results in LN show superiority over standard of care
Immunology Gazyva: Ph III results in LN show superiority over standard of care Ph III results in SLE and INS expected in 2025 Ph III (REGENCY) results: CRR at Week 761 Clinical development 60 Treatment Difference Patients Achieving CRR at Week 76 (% ±95% CI) Primary Endpoint: CRR at 13.4% (95% CI: 2
Slide 33: Vabysmo now the most prescribed therapy in nAMD in the US
Ophthalmology Vabysmo now the most prescribed therapy in nAMD in the US Vabysmo continues to expand market shares across regions; US impacted by contraction of branded market Q1 update Luxturna CHF 34m / + * Susvimo ▪ Vabysmo: Continued market share gains across early launch Lucentis CHF 2m / +171%
Slide 34: Petrelintide: BIC potential as monotherapy and FDC with CT-388
Cardiovascular, Renal & Metabolism Petrelintide: BIC potential as monotherapy and FDC with CT-388 Strengthening our growing CVRM portfolio with a long-acting amylin analog Petrelintide Ph I results: Change in body weight from baseline SAD trial6 MAD trial – Part 17 MAD trial – Part 28 (% change, Day
Slide 35: Petrelintide complementing our growing CVRM portfolio
Cardiovascular, Renal & Metabolism Petrelintide complementing our growing CVRM portfolio Several molecules to move ahead in 2025 Obesity/Diabetes portfolio Roche obesity portfolio: Potential to address unmet needs* Ph I Ph II Roche 1 CT-388 103/104 (Obesity +/- T2D) Unmet need A Current weight loss
Slide 36: 2025: Significant key newsflow ahead
2025: Significant key newsflow ahead* Compound Indication Milestone Itovebi + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC EU approval Columvi + GemOx 2L+ DLBCL US/EU approval (EU approval) Lunsumio SC 3L+ FL US approval/EU filing (EU filing) Elevidys DMD EU approval Regulatory Gazyva Lupus nephri
Slide 37: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 38: Q1 2025: Diagnostics sales
Q1 2025: Diagnostics sales Diagnostics Division stable due to healthcare pricing reforms in China Q1 2025 Q1 2024 Change in % CHFm CHFm CHF CER Diagnostics Division 3,491 3,478 0 0 Core Lab1 1,904 1,926 -1 -1 Molecular Lab 634 611 4 2 Near Patient Care 536 569 -6 -5 Pathology Lab 417 372 12 11 CER:
Slide 39: Q1 2025: Diagnostics highlights
Q1 2025: Diagnostics highlights Diagnostics Division stable due to healthcare pricing reforms in China CHFbn YoY CER growth ▪ Immunodiagnostics (-3%) Core Lab -1% ▪ Clinical Chemistry (+4%) ▪ Infectious diseases (-5%) Molecular Lab +2% ▪ Blood Screening (+6%) Near Patient ▪ BGM (-7%) Care -5% ▪ liat
Slide 40: Q1 2025: Diagnostics regional sales
Q1 2025: Diagnostics regional sales Strong growth in North America, EMEA and Latin America North America +7% EMEA ~33% of divisional sales +4% ~35% of divisional sales Asia Pacific Latin America -15% +11% ~24% of divisional sales ~7% of divisional sales EMEA: Europe, Middle East and Africa; Growth r
Slide 41: Instrument placements
Instrument placements Continued strong growth of instrument placements in 2024 Non-exhaustive Core Lab Molecular Lab Pathology Lab Near Patient Care +10% +7% BenchMark cobas® liat ULTRA/ULTRAPLUS +22% cobas® 5800/6800/8800 analytical units +36% +65% DP200/600 cobas® pro and pure analytical units +4%
Slide 42: cobas Mass Spec solution
cobas® Mass Spec solution The first fully automated IVD solution will revolutionize the Mass Spec segment of the clinical lab Key milestones Customer testimonials • Achieved CE launch for system and steroid 1 assays in “This represents one of the most December 2024 and for Vitamin D assays in Februa
Slide 43: Roche Sequencing solution
Roche Sequencing solution Customer data demonstrates potential of SBX technology ahead of the 2026 commercial launch Early evaluation example: WGS in under 7 hours Market opportunity ▪ The NGS market is valued at USD 6.4bn (2024) and is projected to grow at +9% CAGR from 2024 to 2027¹ ▪ Strong growt
Slide 44: cobas liat CT/NG
cobas® liat CT/NG First FDA cleared/CLIA waived molecular point of care diagnostic for CT/NG cobas® liat assay menu Market opportunity ▪ The molecular STI market is valued at CHF 1bn (2023) and is cobas® liat CT/NG and CT/NG/MG projected to grow at +10% CAGR from 2023 to 2028¹ cobas® liat SARS-CoV-2
Slide 45: Diagnostics key launches 2025
Diagnostics key launches 2025 Area Product Description Market Status Elecsys® pTau 181 Non-invasive blood-based biomarker to enable earlier detection and rule out amyloid pathology CE Elecsys® Troponin-T hs High-sensitive test with greater precision at lower measurement ranges, enabling HCPs to conf
Slide 46: Invitation to Roche Diagnostics Day 2025
Invitation to Roche Diagnostics Day 2025 Highlights: ▪ Deep-dive into the product portfolio and pipeline ▪ Roche SBX Sequencing solution updates and applications Presenters include: ▪ Matt Sause, CEO Roche Diagnostics ▪ Palani Kumaresan, Head of RDS ▪ Moritz Hartmann, Head of RIS Roche Sequencing so
Slide 47: IR events currently planned for 2025
IR events currently planned for 2025 Additional events driven by readouts Immunology/WCN Update on NGS Neurology Update Diagnostics Day Hematology Update Pharma Day 7 Feb 20 Feb 4 Apr 27 May 23 June 22 Sep 16:30-17:30 CET 20:30-21:30 CET 16:00-17:30 CEST 14:00-16:45 CEST 19:00-20:15 CEST tbd Virtual
Slide 48: Doing now what patients need next
Doing now what patients need next
Slide 49: Changes to the development pipeline
Changes to the development pipeline Q1 2025 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 2 NMEs: 2 AIs: RG6662 HTT miRNA GT (SPK-10001) – RG6351 anti-Tie2 agonist - retinal disease RG6631 afimkibart (anti-TL1A) - Crohn’s Huntington's disease RG6287 NME - immunol
Slide 50: Roche Group development pipeline
Roche Group development pipeline Phase I (44 NMEs + 8 AIs) Phase II (17 NMEs + 7 AIs) RG6026 Columvi monotherapy + combos heme tumors CHU CD137 switch solid tumors RG6107 PiaSky sickle cell disease RG6076 englumafusp alfa combos heme tumors CHU paluratide (RAS inhibitor) solid tumors RG6171 giredest
Slide 51: Roche Group development pipeline
Roche Group development pipeline Phase III (8 NMEs + 31 AIs) Registration US & EU (2 NME + 6 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG6026 Columvi + chemo1 2L+ DLBCL Columvi + Polivy + R-CHP 1L DLBCL RG6299 sefaxersen (ASO factor B) IgA nephropathy RG6114 Itovebi + palb
Slide 52: Expected regulatory submissions
Expected regulatory submissions* New Molecular Entities: Lead and additional indications New Molecular Entity (NME) Cardiovascular, Renal & Metabolism Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology Immunology Other *Filing timelines reflect the anticipated filing of a poten
Slide 53: Expected regulatory submissions
Expected regulatory submissions* Marketed products: Additional indications New Molecular Entity (NME) Cardiovascular, Renal & Metabolism Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology Immunology Other ✓ Indicates submission to health authorities has occurred Unless stated o
Slide 54: Major pending approvals 2025
Major pending approvals 2025 US EU China Japan-Chugai Susvimo Itovebi + palbociclib + fulvestrant Columvi + chemo Elevidys RG6321 DR (US) RG6114 1L HR+ PIK3CA-mut. mBC RG6026 2L DLBCL RG6356 DMD Filed April 2024 Filed April 2024 Filed August 2024 Filed August 2024 Columvi + chemo Elevidys Vabysmo RG
Slide 55: Major granted approvals 2025
Major granted approvals 2025 US EU China Japan-Chugai TNKase Columvi + chemo Lunsumio Tecentriq RG3625 stroke RG6026 2L DLBCL RG7828 3L+ FL RG7446 Alveolar Soft Part Sarcoma Feb 2025 April 2024 Dec 2024 Feb 2025 Susvimo Itovebi + palbociclib + fulvestrant RG6321 DME (US) RG6114 1L HR+ PIK3CA-mut. mB
Slide 56: Doing now what patients need next
Doing now what patients need next