Roche Holding Ltd · SIX:RO
Roche — Q3 2024 Earnings Presentation
54 slides from Roche's earnings presentation, Oct 23, 2024
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 2024 sales
Roche YTD September 2024 sales Basel, 23 October 2024
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: Performance Outlook
Performance Outlook
Slide 6: YTD Sep 2024: Strong business performance in both divisions
YTD Sep 2024: Strong business performance in both divisions Good Pharma pipeline progress in Q3: Five regulatory approvals, three positive Ph III readouts and two deals YTD Group sales +6% at CER driven by strong base business of +8% at CER • Strong Pharma (+9% at CER) and Diagnostics (+8% at CER) b
Slide 7: YTD Sep 2024: Group sales growth at +6% with base business at +8%
YTD Sep 2024: Group sales growth at +6% with base business at +8% Both divisions with continued strong momentum YTD Sep YTD Sep 2024 2023 Change in % Excl. CHFbn CHFbn CHF CER C191 Pharmaceuticals Division 34.3 33.4 3 7 9 Diagnostics Division 10.7 10.7 0 5 8 Roche Group 45.0 44.1 2 6 8 1Base busines
Slide 8: YTD Sep 2024: Continued strong growth momentum
YTD Sep 2024: Continued strong growth momentum COVID-19 sales in Diagnostics of CHF 0.3bn in Q4 2023 Group sales growth Group base business sales growth1 %CER %CER +15% +15% +10% +9% +9% +9% +10% +9% +9% +8% +7% +5% +5% +3% +3% +2% +1% +2% +1% 0% 0% COVID-19 Pandemic -3% COVID-19 Pandemic -5% -5% 20
Slide 9: YTD Sep 2024: Strong growth in both divisions
YTD Sep 2024: Strong growth in both divisions Q3 without significant COVID-19 impact Pharma* Diagnostics* Quarterly sales evolution 2022-2024 Quarterly sales evolution 2022-2024 % CER % CER 30% 30% +24% 20% 20% +12% +9% +10% +10% +9% +9% +7% +7% +7% +7% +8% +8% +7% +8% +8% +9% +7% 10% +6% +4% 10% +4
Slide 10: Key growth drivers of the Roche portfolio
Key growth drivers of the Roche portfolio Significant milestones achieved in Q3 to enable future growth +5% YTD Sep 2024 sales Diagnostics: +8% base business growth (CHFbn, YoY CER growth) (+8%)* Significant launches upcoming Itovebi: US approval in 1L PIK3CA-mut HR+ BC 10.7 Tecentriq Hybreza: US ap
Slide 11: Performance Outlook
Performance Outlook
Slide 12: Young portfolio to drive growth in the near- to mid-term
Young portfolio to drive growth in the near- to mid-term 2024 NME update: US approval for Itovebi (inavolisib) in HR+ breast cancer and PiaSky in PNH achieved CHFm % of Pharma Sales2 20.0 56% 18.0 50% 16.0 42% 14.0 12.0 34% 10.0 8.0 1 6.0 4.0 2.0 0.0 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023 YTD Sep 20
Slide 13: Key growth drivers beyond 2025
Key growth drivers beyond 2025 Many opportunities with significant market potential in both divisions Pharmaceuticals Diagnostics NME Indication Newsflow Timing Product Description Launch tiragolumab NSCLC/other Ph III data 2024/25 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 14: Key growth drivers beyond 2025
Key growth drivers beyond 2025 Many opportunities with significant market potential in both divisions Pharmaceuticals Diagnostics NME Indication Newsflow Timing Product Description Launch tiragolumab NSCLC/other Ph III data 2024/25 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 15: Positive 2024 outlook
Positive 2024 outlook Sales drivers1 Continued strong base business growth in both divisions Group sales growth1 Mid single digit sales growth COVID-19 sales expected to decline by roughly CHF 1.1bn LOE impact of roughly CHF 1.4bn expected Base business=Pharma excluding Ronapreve and Diagnostics exc
Slide 16: 2024 guidance raised at HY
2024 guidance raised at HY Core EPS guidance raised from “broadly in line with sales” to “high single digit Core EPS growth” Group sales growth1 Mid single digit sales growth High single digit Core EPS growth Core EPS growth1 excl. impact from resolution of tax disputes in 2023 Dividend outlook Furt
Slide 17: Finance
Finance Alan Hippe Chief Financial Officer
Slide 18: Upcoming Roche IR events 2024
Upcoming Roche IR events 2024 Additional events driven by readouts Neurology/CTAD Digitalization Day 31 Oct 25 Nov • Overview of the Roche • Roche digital efforts in Pharma Alzheimer's Disease pipeline early R&D • Focus on Ph I/II trontinemab • Highlighting use cases “lab-in- data presented at CTAD
Slide 19: YTD Sep 2024: Base business growth exceeds COVID-19 and LOE impact
YTD Sep 2024: Base business growth exceeds COVID-19 and LOE impact COVID-19 sales decrease and LOE impact in line with guidance CHFm +6% at CER -517 +3,603 -819 -1,887 +815 -264 44,053 44,984 YTD Sep 2023 Dia Dia Pharma Ronapreve LOE Fx YTD Sep 2024 base COVID-19 (excl. Ronapreve, sales business sal
Slide 20: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact driven by the USD, JPY, CNY (APAC) and EUR -0.3%p -0.7%p -1.2%p CER CHF sales growth -0.7%p sales growth Sep YTD 2024 Sep YTD 2024 +6% vs. -0.7%p vs. Sep YTD 2023 Sep YTD 2023 -0.4%p +2% CER EUR APAC USD LATAM JPY Other CHF CER=Constant Exchange R
Slide 21: Expected 2024 currency impact
Expected 2024 currency impact USD / CHF Assumed avg. YTD 2024 Assuming the 30 September 2024 exchange rates remain -6% -3% -2% -3% stable until end of 2024, 0.93 0.91 2024 impact1 is expected to be (%p): 0.90 0.90 0.87 Q1 Q2 Q3 Q4 0.89 0.88 0.87 Sales -8 -2 -3 -5 0.86 0.88 0.89 0.91 0.91 0.89 0.89 0
Slide 22: 2024 guidance raised at HY
2024 guidance raised at HY Core EPS guidance raised from “broadly in line with sales” to “high single digit Core EPS growth” Group sales growth1 Mid single digit sales growth High single digit Core EPS growth Core EPS growth1 excl. impact from resolution of tax disputes in 2023 Dividend outlook Furt
Slide 23: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 24: YTD Sep 2024: Pharmaceuticals sales
YTD Sep 2024: Pharmaceuticals sales All regions ex-Japan delivering strong growth, Japan impacted by Ronapreve sales in Q1 2023 YTD Sep YTD Sep 2024 2023 Change in % CER w/o CHFm CHFm CHF CER Ronapreve Pharmaceuticals Division 34,257 33,372 3 7 9 United States 18,166 17,430 4 7 7 Europe 6,613 6,259
Slide 25: YTD Sep 2024: Young portfolio delivering strong growth
YTD Sep 2024: Young portfolio delivering strong growth Vabysmo and Phesgo excellent growth momentum continues; strong ex-US uptake for Elevidys Vabysmo 79% Phesgo 58% Ocrevus 9% Hemlibra 10% Polivy 41% Evrysdi 21% Xolair 11% Elevidys n/a Columvi >500% Actemra / RoActemra 5% Alecensa 7% Gazyva 13% Xo
Slide 26: Itovebi (inavolisib) US approval in 1L PIK3CA-mut HR+ BC achieved
Oncology/Hematology Itovebi (inavolisib) US approval in 1L PIK3CA-mut HR+ BC achieved Complementing pipeline via Regor deal, adding CDK4/2 (Ph I) and CDK4 (Ph I-ready) in HR+ breast cancer* Others Q3 update Avastin CHFm 489 / -15% • Phesgo: Strong uptake and conversion at 43% (55 countries)** CHFm 9
Slide 27: Breast Cancer: Itovebi in PIK3CA-mut HR+ BC to define new SoC
Oncology/Hematology Breast Cancer: Itovebi in PIK3CA-mut HR+ BC to define new SoC Itovebi first PI3Ki approved in 1L ET resistant setting, with BIC potential in breast cancer and beyond Breast cancer portfolio Potential for Itovebi based regimen in PIK3CA-mut HR+ BC Low risk (~55%)1 Medium risk (~25
Slide 28: Next generation CDKi portfolio acquired from Regor Therapeutics
Oncology/Hematology Next generation CDKi portfolio acquired from Regor Therapeutics* RGT-419B (CDK4/2i) in Ph I with best-in-class potential in HR+ BC, and Ph I ready RGT-587 (CDK4i) Next generation CDKi portfolio RGT-419B development program Potent CDK4 inhibition with activity on CDK21 Completed O
Slide 29: Polivy US patient share in 1L DLBCL reaching 28%
Oncology/Hematology Polivy US patient share in 1L DLBCL (IPI 0-5) reaching 28% NXT007 Ph III-enabling data in Hemophilia A expected in 2025 Lunsumio Q3 update Columvi CHFm 54 / +28% CHFm 116 / >500% • Hemlibra: Continued penetration across all approved patient PiaSky Gazyva CHFm 8 / N/A segments wit
Slide 30: Ocrevus Zunovo (SC) US approval in MS achieved
Neurology Ocrevus Zunovo (SC) US approval in MS achieved Positive fenebrutinib Ph II (FENopta) 48 weeks data in RMS presented at ECTRIMS Elevidys Q3 update CHFm 137 / N/A Others CHFm 300 / +5% • Ocrevus: #1 new to brand in US; higher retention rate than other Enspryng MS medicines; 1,000,000 patient
Slide 31: Positive Ph III (REGENCY) for Gazyva in lupus nephritis
Immunology Positive Ph III (REGENCY) for Gazyva in lupus nephritis Ph III (AMETRINE-1&2) for anti-TL1A in UC initiated Q3 update Others • Xolair: Strong food allergy launch with ~30k pts on treatment CHFm 687 / -12% • Additional growth driven by strong CSU performance MabThera/ • No biosimilar launc
Slide 32: Vabysmo US market share growth in nAMD, DME and RVO continues
Ophthalmology Vabysmo US market share growth in nAMD, DME and RVO continues Vabysmo EU RVO approval achieved; rapid conversion to pre-filled syringe in US Luxturna Q3 update CHFm 15 / -65% Susvimo Lucentis CHFm 3 / +18% • Vabysmo: Continued market share gains across early launch CHFm 119 / -69% coun
Slide 33: Obesity: Pipeline with potentially unique combination opportunities
Cardiovascular, Renal & Metabolism Obesity: Pipeline with potentially unique combination opportunities Despite numerous approved treatments, unmet need remains; Roche set up to leverage obesity opportunity Obesity portfolio Roche’s obesity pipeline Unmet need Differentiation strategy Ph I Ph II Effi
Slide 34: Pipeline update: Strengthening the Pharma pipeline
Pipeline update: Strengthening the Pharma pipeline NME changes in Q3 NME and LE (QoQ change, Q3 24 vs Q2 24) Phase Indication RG6434 I Neurology ±0 -4 2 2 2 ±0 LTBR agonist I Solid tumors ±0 6 6 -2 CDK4/2i (RGT-419B)* I HR+ breast cancer ±0 11 8 -1 PiaSky** Reg. PNH ±0 4 1 ±0 71 (-6) 6 ±0 tobemstomi
Slide 35: 2024: Key newsflow
2024: Key newsflow* Compound Indication Milestone Alecensa Adjuvant ALK+ NSCLC US/EU approval inavolisib + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC US/EU filing Tecentriq Subcutaneous administration US/EU approval PiaSky (crovalimab) PNH US/EU approval Elevidys DMD EU filing Ocrevus 6m SC RMS/
Slide 36: 2025: Significant key newsflow ahead
2025: Significant key newsflow ahead* Compound Indication Milestone inavolisib + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC EU approval Columvi + GemOx 2L+ DLBCL US/EU approval Lunsumio SC 3L+ FL US/EU approval Elevidys DMD EU approval Regulatory Gazyva Lupus nephritis US/EU filing; US approval
Slide 37: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 38: YTD Sep 2024: Diagnostics Division sales
YTD Sep 2024: Diagnostics Division sales Strong base business growth more than offsetting decline in COVID-19 sales YTD Sep YTD Sep Change in % 2024 2023 Excl. CHFm CHFm CHF CER C191 Diagnostics Division 10,727 10,681 0 5 8 Core Lab 6,052 5,836 4 9 Molecular Lab 1,903 1,897 0 4 Near Patient Care 1,6
Slide 39: YTD Sep 2024: Diagnostics highlights
YTD Sep 2024: Diagnostics highlights Strong base business growth more than offsetting decline in COVID-19 sales CHFbn YoY CER growth • Immunodiagnostics (+10%) Core Lab +9% • Clinical Chemistry (+8%) • Custom biotech (+5%) • COVID-19 (-62%) Molecular Lab +4% • Virology base business (+12%) • Blood S
Slide 40: YTD Sep 2024: Diagnostics regional sales
YTD Sep 2024: Diagnostics regional sales Strong base business growth across all regions North America +6% EMEA ~30% of divisional sales +5% ~34% of divisional sales Asia Pacific Latin America +2% +18% ~29% of divisional sales ~7% of divisional sales Base business=excluding COVID-19-related products;
Slide 41: cobas pro serology solution
Core Lab cobas® pro serology solution FDA approval enables entry into the largest donor screening market in the world cobas® pro serology solution1 Market opportunity • The U.S. Serology blood screening market is ~40% of the Instrument Assays global CHF 900m market • Safety of plasma-derived product
Slide 42: FDA self-collection approval for cobas HPV test
Molecular Lab FDA self-collection approval for cobas HPV test Increases access and options for women in the US HPV self-collection process Market needs and opportunity • >13,000 new cervical cancer patients are diagnosed and ~4,000 die in the US every year1 Analysis on Roche cobas® • ~30% of eligibl
Slide 43: cobas Respiratory flex for use on cobas x800 Systems
Molecular Lab cobas® Respiratory flex for use on cobas® x800 Systems Flexible syndromic testing empowered by Roche’s novel and proprietary TAGS technology Empowered by TAGS 5 channels = up to 15 targets Market opportunity • Address multiplex panel market utilizing large installed high base • Innovat
Slide 44: LumiraDx deal closed
Near Patient Care LumiraDx deal closed Potentially disruptive solution for the Point of Care setting LumiraDx key attributes Value to healthcare systems and Roche • Multi-modal technology that can • Consolidate Point of Care testing on a single perform clinical chemistry, immunoassay, platform (such
Slide 45: Diagnostics key launches 2024
Diagnostics key launches 2024 Area Product Description Markets Status i601 mass spectrometry Launch of an unique total solution for clinical mass spectrometry testing: fully automated, integrated and CE system IVD-compliant Core Lab cobas c703 Introducing high-throughput clinical chemistry testing t
Slide 46: Roche Group development pipeline
Roche Group development pipeline
Slide 47: Changes to the development pipeline
Changes to the development pipeline Q3 2024 update New to phase I New to phase II New to phase III New to registration 3 NMEs: 2 NME: 2 NME: 1 AI: RG6221 LTBR agonist – solid tumors RG6512 FIXa x FX (NXT007) - hemophilia RG6631 anti-TL1A - ulcerative colitis RG6026 Columvi + chemo - 2L+ DLBCL RG6434
Slide 48: Roche Group development pipeline
Roche Group development pipeline Phase I (46 NMEs + 8 AIs) Phase II (15 NMEs + 8 AIs) RG6026 Columvi monotherapy + combos heme tumors CHU glypican-3 x CD3 solid tumors tiragolumab + T NSCLC RG6058 RG6058 tiragolumab combos solid tumors CHU codrituzumab HCC tiragolumab + T 1L PD-L1+ mSCCHN RG6076 eng
Slide 49: Roche Group development pipeline
Roche Group development pipeline Phase III (8 NMEs + 33 AIs) Registration US & EU (2 NME + 5 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG6026 Columvi + chemo** 2L+ DLBCL Columvi + Polivy + R-CHP 1L DLBCL RG6299 ASO factor B IgA nephropathy Itovebi (inavolisib) + RG6026 RG6
Slide 50: Expected regulatory submissions
Expected regulatory submissions* New Molecular Entities: Lead and additional indications anti-latent myostatin RG6237 (GYM 329) + Evrysdi SMA New Molecular Entity (NME) Cardiovascular, Renal & Metabolism anti-latent myostatin Additional Indication (AI) Neurology giredestrant RG6237 (GYM 329) RG6171
Slide 51: 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 52: Major pending approvals 2024
Major pending approvals 2024 US EU China Japan-Chugai TNKase Itovebi (inavolisib) + palbociclib + Ocrevus Tecentriq fulvestrant RG1594 RMS & PPMS RG7446 Alveolar Soft Part Sarcoma RG3625 stroke RG6114 1L HR+ PIK3CA-mut. mBC Filed March 2024 Filed Jan 2024 Filed June 2023 Filed April 2024 Itovebi (in
Slide 53: Major granted approvals 2024
Major granted approvals 2024 US EU China Japan-Chugai Xolair Tecentriq SC PiaSky PiaSky RG3648 Food allergy RG7446 all approved indications RG6107 PNH RG6107 PNH Feb 2024 Jan 2024 Feb 2024 March 2024 Alecensa Alecensa Vabysmo Vabysmo RG7853 ALK+ NSCLC adj RG7853 ALK+ NSCLC adj RG7716 BRVO/CRVO RG771
Slide 54: Doing now what patients need next
Doing now what patients need next