Roche Holding Ltd · SIX:RO
Roche — Q3 2025 Earnings Presentation
56 slides from Roche's earnings presentation, Oct 23, 2025
Slide 1: Roche
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 YTD September 2025 sales
Roche YTD September 2025 sales Basel, 23 October 2025
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: YTD Sep 2025 Performance, Pipeline Update, Outlook
YTD Sep 2025 Performance Pipeline Update Outlook
Slide 6: YTD Sep 2025: Continued strong financial performance
YTD Sep 2025: Continued strong financial performance YTD September results at CER ▪ Group sales growth +7%, +9% for Pharma and +1% for Diagnostics (due to China healthcare pricing reforms) ▪ Full year LOE impact expectation lowered to CHF 0.8bn Key milestones achieved in Q3 ▪ Pharma regulatory: US a
Slide 7: YTD Sep 2025: Strong Pharma sales driving Group growth
YTD Sep 2025: Strong Pharma sales driving Group growth Diagnostics division growing +1% impacted by healthcare pricing reforms in China YTD Sep YTD Sep 2025 2024 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 35.6 34.3 4 9 Diagnostics Division 10.3 10.7 -4 1 Roche Group 45.9 45.0 2 7 CER:
Slide 8: YTD Sep 2025: Consistent strong growth
YTD Sep 2025: Consistent strong growth Diagnostics impacted by healthcare pricing reforms in China Group sales growth %CER +15% +10% +9% +9% +9% +9% +8% +6% +6% +5% +2% +1% +2% +1% 0% COVID-19 pandemic Pandemic phase out Post-pandemic Base business: +1%* Base business: +8%* Business growth: +8%* 202
Slide 9: Key growth drivers of the Roche portfolio
Key growth drivers of the Roche portfolio All therapeutic areas delivering strong growth; Diagnostics impacted by healthcare pricing reforms in China Diagnostics: Molecular Lab and YTD Sep 2025 sales Pathology Lab with strong growth; Core (CHFbn, YoY CER growth) Lab impacted by China healthcare +1%
Slide 10: YTD Sep 2025 Performance, Pipeline Update, Outlook
YTD Sep 2025 Performance Pipeline Update Outlook
Slide 11: Further pipeline progression through 89bio acquisition
Further pipeline progression through 89bio acquisition* Prioritization of high-impact projects while increasing the total portfolio value Portfolio evolution (NME additions / removals) Portfolio value Average peak sales per pipeline project, CHF bn1 8 -8 +57% 81 4 -3 1 FGF21 analog -5 in MASH* 3 -4
Slide 12: 10 NMEs new to Ph III in 2025
10 NMEs new to Ph III in 2025 5 Ph III decisions taken in Q3: CT-388, CT-868, zilebesiran, cevostamab and HER2 TKI NXT007 in cevostamab in HER2 TKI in trontinemab in prasinezumab in zosurabalpin in zilebesiran in CT-388 in CT-868 in pegozafermin in hemophilia A R/R MM HER2+ BC AD PD MDR bacterial in
Slide 13: Overall portfolio shift after introduction of the Bar
Overall portfolio shift after introduction of the Bar Total portfolio value +27% since FY ’23 while 55% of clinical pipeline now consisting of post Bar assets Risk-reward profile of assets with Ph III Go decisions pre vs. post Bar1 Portfolio composition (# of NMEs)2 illustrative 37 20 Includes Ph II
Slide 14: 2025 Pharma pipeline: Q3 newsflow
2025 Pharma pipeline: Q3 newsflow Up to 19 NMEs with launch potential by 2030 0.5-1bn peak sales 1-2bn peak sales afimkibart 2-3bn peak sales >3bn peak sales CT-388 IBD, AtD, AD, RA, MASH Obesity +/- T2D sefaxersen CT-868 IgAN T1D with BMI ≥25 zosurabalpin CT-996 Bacterial infections Obesity +/- T2D
Slide 15: Roche Diagnostics: Key technologies to drive future growth
Roche Diagnostics: Key technologies to drive future growth New SBX data at ASHG, including GUINNESS WORLD RECORDSTM title for fastest DNA sequencing technique AXELIOS 1: Roche sequencing solution Accu-Chek® SmartGuide cobas® i601 Mass Spec Molecular Lab Near Patient Care Core Lab Roche sequencing so
Slide 16: YTD Sep 2025 Performance, Pipeline Update, Outlook
YTD Sep 2025 Performance Pipeline Update Outlook
Slide 17: A solid base to deliver long-lasting future growth
A solid base to deliver long-lasting future growth Emerging pipeline complemented by business development to add significant upside potential illustrative Business development ▪ BD to accelerate pipeline rejuvenation ▪ In-house pipeline with upside potential Pharma pipeline ▪ Today’s on-market Pharm
Slide 18: 2025 guidance raised
2025 guidance raised LOE impact of CHF 0.8bn (CER, updated from CHF 1.0bn) expected for 2025 Group sales growth1 Mid single digit sales growth High single digit to low double digit Core EPS growth Core EPS growth1 (from high single digit growth) Dividend outlook Further increase dividend in Swiss fr
Slide 19: Finance
Finance Alan Hippe Chief Financial Officer
Slide 20: YTD Sep 2025: Group growth +7% at CER
YTD Sep 2025: Group growth +7% at CER Pharma Division driving Group growth +7% at CER CHFm +608 +3,399 -474 -517 -2,138 44,984 45,862 2024 Pharma LOE Dia China Fx 2025 (excl. LOE) (excl. China) healthcare pricing reforms CER: Constant exchange rates (avg. full year 2024); LOE: Loss of exclusivity in
Slide 21: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact mainly driven by the USD, CNY (APAC), EUR and ARS, BRL, MXN in LATAM -0.3%p -0.7%p -2.3%p CER CHF sales growth sales growth 2025 +6.7% 2025 vs. vs. -0.8%p 2024 2024 -0.1%p -0.5%p +2.0% CER EUR APAC USD LATAM JPY Other CHF CER: Constant exchange ra
Slide 22: Expected 2025 currency impact
Expected 2025 currency impact USD / CHF Assumed avg. YTD 2025 +3% -3% -4% -6% Assuming the 30 September 2025 exchange rates remain 0.90 0.89 stable until end of 2025, 0.88 0.88 2025 impact1 is expected to be (%p): 0.87 0.86 0.84 0.83 Q1 Q2 Q3 Q4 0.91 0.90 0.88 0.84 0.83 0.82 0.80 0.81 0.80 0.80 0.80
Slide 23: 2025 guidance raised
2025 guidance raised LOE impact of CHF 0.8bn (CER, updated from CHF 1.0bn) expected for 2025 Group sales growth1 Mid single digit sales growth High single digit to low double digit Core EPS growth Core EPS growth1 (from high single digit growth) Dividend outlook Further increase dividend in Swiss fr
Slide 24: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 25: YTD Sep 2025: Pharmaceuticals sales
YTD Sep 2025: Pharmaceuticals sales Strong growth across all regions YTD Sep YTD Sep 2025 2024 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 35,555 34,257 4 9 United States 18,798 18,166 3 8 Europe 6,818 6,613 3 5 Japan 2,139 2,083 3 5 International 7,800 7,395 5 ##### 13 CER: Constant exch
Slide 26: YTD Sep 2025: Diversified set of key growth drivers
YTD Sep 2025: Diversified set of key growth drivers Phesgo, Xolair, Hemlibra, Vabysmo, Ocrevus and Polivy driving growth Phesgo 54% Xolair 34% Hemlibra 12% Vabysmo 13% Ocrevus 7% Polivy 40% Xofluza 163% Evrysdi 8% Columvi 81% Alecensa 8% Gazyva 13% Elevidys 64% Itovebi n/a Enspryng 26% Actemra / RoA
Slide 27: Oncology growing +2% driven by the HER2+ franchise
Oncology/Hematology Oncology growing +2% driven by the HER2+ franchise Positive Ph III (evERA) giredestrant in post-CDK4/6i ER+ mBC; HER2 TKI entering Ph II/III in HER2+ BC Q3 update Itovebi Avastin CHF 68m / N/A ▪ Phesgo: Global conversion rate climbing to 51%* CHF 763m / -15% Others ▪ Perjeta: Con
Slide 28: Giredestrant: Positive Ph III (evERA) in ESR1m and ITT post-CDKi ER+ mBC
Oncology/Hematology Giredestrant: Positive Ph III (evERA) in ESR1m and ITT post-CDKi ER+ mBC Potential to be the first only-oral SERD combination therapy in the post-CDKi setting Ph III (evERA) INV-PFS results in post CDK4/6i ER+/HER2- mBC1 ESR1m population ITT population Giredestrant + SOC ET + Gir
Slide 29: Giredestrant: Ph III (evERA) shows manageable safety profile
Oncology/Hematology Giredestrant: Ph III (evERA) shows manageable safety profile Well-tolerated and safety profile aligned with individual drug profiles; no photopsia Ph III (evERA) safety in post CDK4/6i ER+/HER2- mBC1 Giredestrant + everolimus SOC ET + everolimus n = 182 n = 186 Giredestrant: 7.11
Slide 30: Polivy US patient share in 1L DLBCL reaching 35%
Oncology/Hematology Polivy US patient share in 1L DLBCL (IPI 0-5) reaching 35% Hemlibra with continued global growth; cevostamab entering Ph III in R/R MM Q3 update Lunsumio Columvi CHF 77m / +47% ▪ Hemlibra: Increasing adoption in non-inhibitor patients CHF 202m / +81% PiaSky ▪ Polivy: Strong 1L DL
Slide 31: Ocrevus: ~50% of SC starts in the US are new to brand
Neurology Ocrevus: ~50% of SC starts in the US are new to brand Trontinemab: Ph III in pre-clinical AD to be initiated; FPI achieved for Ph III (TRONTIER 1/2) in early AD Q3 update Elevidys Others ▪ Ocrevus: >12,500 patients on Ocrevus SC globally CHF 221m / +64% CHF 284m / 0% ▪ US: 60% of SC volume
Slide 32: Xolair with continued strong launch in food allergy
Immunology Xolair with continued strong launch in food allergy Gazyva achieved US approval in lupus nephritis Q3 update ▪ Xolair: Strong food allergy launch with >85k patients on treatment Others CHF 680m / +4% Actemra ▪ Biosimilar launch expected end of 2026 CHF 1,893m / +2% ▪ Actemra: Q3 biosimila
Slide 33: Vabysmo remains impacted by US branded market contraction
Ophthalmology Vabysmo remains impacted by US branded market contraction Ph III results for vamikibart in UME and satralizumab in TED to be discussed with health authorities Q3 update Luxturna CHF 39m / +178% Susvimo ▪ Vabysmo: Continued market share gains across early launch Lucentis CHF 6m / +117%
Slide 34: Vamikibart in UME: Ph III results show vision improvement
Ophthalmology Vamikibart in UME: Ph III results show vision improvement Novel targeted treatment strategy may offer a nonsteroid IVT treatment option for UME patients Ph III (MEERKAT/SANDCAT) results1 Primary endpoint Secondary endpoints * Proportion of pts with ≥ 15 letter BCVA gain from baseline i
Slide 35: Satralizumab in TED: Ph III shows differentiated benefit-risk profile
Ophthalmology Satralizumab in TED: Ph III shows differentiated benefit-risk profile Potentially first IL-6R inhibitor for active and inactive TED with convenient subcutaneous dosing Ph III (SatraGO-1/2) results: Primary endpoint and safety1 Proptosis response at Week 24 (active TED) Safety (active +
Slide 36: CVRM pipeline: CT-388, CT-868 and zilebesiran new to Ph III
Cardiovascular, Renal & Metabolism CVRM pipeline: CT-388, CT-868 and zilebesiran new to Ph III Clinical development Q3 update ▪ Pegozafermin in MASH: Potential for BID Indication Asset Ph I Ph II Ph III ▪ Ph III (ENLIGHTEN fibrosis) in MASH (F2-3) readout in H1 ’27 Hypertension zilebesiran KARDIA-1/
Slide 37: Pegozafermin: Potential best-in-disease therapy in MASH
Cardiovascular, Renal & Metabolism Pegozafermin: Potential best-in-disease therapy in MASH Further strengthens CVRM portfolio and offers optionality for future combination development Pegozafermin1 Ph II (ENLIVEN) week 24 results in pts with MASH and fibrosis (F2-F4)2* Fibrosis improvement ≥ 1stage
Slide 38: 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 / (US/EU) Lunsumio SC 3L+ FL US approval/EU filing (EU filing) Elevidys DMD EU approval Regulatory Gazyva Lupus nephritis
Slide 39: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 40: YTD Sep 2025: Diagnostics sales
YTD Sep 2025: Diagnostics sales Diagnostics growing at +1%, China healthcare pricing reforms continue CER: Constant exchange rates (avg. full year 2024) 40
Slide 41: YTD Sep 2025: Diagnostics highlights
YTD Sep 2025: Diagnostics highlights Diagnostics growing at +1%, China healthcare pricing reforms continue CHFbn YoY CER growth ▪ Immunodiagnostics (-5%) Core Lab -1% ▪ Clinical Chemistry (+6%) ▪ Infectious diseases (0%) Molecular Lab +4% ▪ Blood Screening (+5%) Near Patient ▪ BGM (-2%) -4% ▪ Liat P
Slide 42: YTD Sep 2025: Diagnostics regional sales
YTD Sep 2025: Diagnostics regional sales Strong growth in Latin America, North America, and EMEA North America +7% EMEA ~32% of divisional sales +6% ~36% of divisional sales Asia Pacific Latin America -15% +14% ~25% of divisional sales ~7% of divisional sales Growth rates at constant exchange rates
Slide 43: AXELIOS 1: Roche Sequencing solution
AXELIOS 1: Roche Sequencing solution World’s fastest whole human genome sequencing to date Whole genome sequencing with SBX1 Context ▪ Unmet need: Rapid genetic diagnosis is key in critical care; yet current sequencing methods require multiple days SBX-D Xpandomer Variant ▪ Study objective: Investig
Slide 44: AXELIOS 1: Roche Sequencing solution
AXELIOS 1: Roche Sequencing solution Significant progress across research workflows including methylation and RNA-sequencing Methylation SBX Simplex Longer RNA sequencing1 Fraction of Isoforms Detected 100% 99.3% ATCG Library Prep TAPS Conversion Base calling (TPM > 0.05) True variant 95% 94.6% 93.8
Slide 45: Elecsys pTau181 CE mark and FDA clearance
Neurology Elecsys® pTau181 CE mark and FDA clearance First FDA cleared blood-based test to rule out Alzheimer's disease in primary care Elecsys® pTau1811 Market needs and opportunity ▪ High Burden: Alzheimer's is the leading cause of dementia, a condition projected to reach 80m by 20302 Patients wit
Slide 46: Elecsys pTau217 study readouts
Neurology Elecsys® pTau217 study readouts Study results support broad implementation of Elecsys® pTau217 in routine clinical practice Roche internal study results External customer study results Effect of pre-analytical variation on clinical ROC-AUC analysis across pTau217 solutions2 performance1 ▪
Slide 47: 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 48: Roche Group development pipeline
Roche Group development pipeline
Slide 49: Changes to the development pipeline
Changes to the development pipeline Q3 2025 update New to phase I New to phase II New to phase III New to registration 1 NME: 2 NMEs: 3 NMEs: 1 NME (EU): CHU pan-KRAS inhibitor (AUBE00) – solid tumors RG6652 GLP-1 RA (CT-996) - obesity +/- T2D RXXXX1,2 pegozafermin - MASH with fibrosis RG6321 Susvim
Slide 50: Roche Group development pipeline
Roche Group development pipeline Phase I (38 NMEs + 7 AIs) Phase II (17 NMEs + 6 AIs) RG6026 Columvi monotherapy + combos heme tumors RG6382 CD19 x CD3 SLE RG6171 giredestrant endometrial cancer RG6076 englumafusp alfa combos heme tumors RG6377 - IBD RG6180 autogene cevumeran solid tumors RG6114 Ito
Slide 51: Roche Group development pipeline
Roche Group development pipeline Phase III (10 NMEs + 28 AIs) Registration US & EU (3AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG7828 Lunsumio SC 3L+ FL RG6013 Hemlibra Type 3 VWD RG6299 sefaxersen (ASO factor B) IgA nephropathy RG7159 Gazyva1 lupus nephritis Columvi + Pol
Slide 52: Expected regulatory submissions
Itovebi + CDK4/6i + letrozole RG6114 Expected regulatory submissions* 1L ES PIK3CA-mut. HR+ HER2- advanced BC autogene cevumeran New Molecular Entities: Lead and additional indications RG6180 solid tumors prasinezumab FIXa x FX (NXT007) RG7935 RG6512 Parkinson’s hemophilia New Molecular Entity (NME)
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 PiaSky RG6107 aHUS Tecentriq ✓ Indicates submission to health authorities
Slide 54: Major pending approvals 2025
Major pending approvals 2025 US EU China Japan-Chugai Xofluza Lunsumio SC Polivy + chemo Tecentriq RG6152 influenza direct transmission RG7828 3L+FL RG7596 r/r DLBCL RG7446 unresectable thymic carcinoma Filed Nov 2024 Filed Nov 2024 Filed May 2025 Filed May 2025 Lunsumio SC Gazyva Lunsumio + Polivy
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 2025 Dec 2024 Feb 2025 Susvimo Xofluza Itovebi + palbociclib + fulvestrant Elevidys RG6321 DME RG6152 influenza
Slide 56: Doing now what patients need next
Doing now what patients need next