Roche Holding Ltd · SIX:RO
Roche — Q1 2024 Earnings Presentation
63 slides from Roche's earnings presentation, Apr 24, 2024
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 2024 sales
Roche Q1 2024 sales Basel, 24 April 2024
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: Performance Outlook
Performance Outlook
Slide 6: Q1 2024: Strong base business growth in both divisions
Q1 2024: Strong base business growth in both divisions Good pipeline progress, COVID-19 and currency headwinds diminishing Group sales +2% at CER driven by strong base business of +7% • Strong Pharma (+7% at CER) and Diagnostics (+8% at CER) base business growth • COVID-19 sales decreased by CHF -0.
Slide 7: Q1 2024: Base business growing at +7%
Q1 2024: Base business growing at +7% Both divisions with continued strong momentum 2024 2023 Change in % Excl. CHFbn CHFbn CHF CER C191 Pharmaceuticals Division 10.9 11.6 -6 2 7 Diagnostics Division 3.5 3.7 -6 2 8 Roche Group 14.4 15.3 -6 2 7 1Base business=Pharma excluding Ronapreve and Diagnostic
Slide 8: Q1 2024: Base business overcompensating for COVID-19 and LOE
Q1 2024: Base business overcompensating for COVID-19 and LOE Currency impact of -8%p in Q1, current full year projection of -2%p CHFm +2% at CER -518 +250 +1,080 -385 -194 -1,156 15,322 14,399 2023 Dia Dia Pharma Ronapreve LOE Fx 2024 base COVID-19 (excl. Ronapreve, sales business sales LOE) Base bu
Slide 9: Q1 2024: Strong momentum in the base business for the Group
Q1 2024: Strong momentum in the base business for the Group No material COVID-19 impact going forward Roche Group Annual sales evolution 2018-2024 % CER +10% +9% +9% +8% +7% +5% +3% +3% +2% +1% +1% 0% +2% -3% FY 2019 FY 2020 FY 2021 FY 2022 FY 2023 Q1 2024 Group sales growth Group sales growth (base
Slide 10: Q1 2024: Base businesses in both divisions grow high single digit
Q1 2024: Base businesses in both divisions grow high single digit No material COVID-19 impact going forward Pharma* Diagnostics* Quarterly sales evolution 2022-2024 Quarterly sales evolution 2022-2024 % CER % CER +30% +30% +24% +20% +20% +12% +9% +9% +7% +10% +8% +8% +8% +10% +6% +7% +7% +10% +7% +8
Slide 11: Pipeline update: Strengthening the Pharma pipeline
Pipeline update: Strengthening the Pharma pipeline Portfolio shaping ongoing: Focus on high-impact projects led to termination of 20% of total NMEs since Q3 23 NME changes in Q1 NME and LE (QoQ change, Q1 24 vs Q4 23) ±0 2 ±0 6 9 +1 Phase Indication LepB inhibitor -1 11 8 ±0 I UTI (RG6436) ±0 5 2 ±0
Slide 12: Vacaville sale: Optimizing our Pharma manufacturing network
Vacaville sale: Optimizing our Pharma manufacturing network • Vacaville site sold for USD ~1.2bn* • Global network investment to Hillsboro Mannheim enable portfolio evolution Basel Penzberg South San Philadelphia Kaiseraugst Francisco Vacaville Shanghai Tokyo • Building capabilities in new Oceanside
Slide 13: Optimizing manufacturing network to address portfolio evolution
Optimizing manufacturing network to address portfolio evolution Addressing the demands of producing diverse molecules with smaller volume production needs Biologics portfolio evolution 15 Bubble size corresponds to total annual volume (kL) needed per product 2025 - 2035 Large volume production in 12
Slide 14: Realizing synergies in Diagnostics and the Group
Realizing synergies in Diagnostics and the Group Acting on opportunities across the Group to improve operational performance FMI Near Patient Care* Shift of FMI from Pharma to Diagnostics Division Integration of Point of Care and Diabetes Care Leverage complementary patient/customer Combine our Diag
Slide 15: Performance Outlook
Performance Outlook
Slide 16: Young portfolio to drive growth in the near- to mid-term
Young portfolio to drive growth in the near- to mid-term Two NME approvals expected for 2024: PiaSky (crovalimab) in PNH1 and inavolisib in HR+ breast cancer CHFm % of Pharma Sales3 7,000 50% 55% 6,000 5,000 42% 4,000 32% 3,000 2 2,000 1,000 0 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Q1 202
Slide 17: Declining COVID-19 related headwinds in 2024
Declining COVID-19 related headwinds in 2024 Q1 2024 is the final quarter materially impacted by declining COVID-19 sales, minor impact expected in Q4 CHFbn CER CHF ~1.1bn erosion expected 1.0 COVID-19 Tests Ronapreve 0.8 0.8 CHF 0.7bn erosion 0.6 0.4 0.3 0.2 0.1 0.1 0.1 0.0 Q1 23 Q2 23 Q3 23 Q4 23
Slide 18: 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 Final Ph III data H2 2024 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 19: 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 Final Ph III data H2 2024 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 20: 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 LOE2 impact of roughly CHF 1.6bn expected Base business=Pharma excluding Ronapreve and Diagnostics ex
Slide 21: 2024 guidance confirmed
2024 guidance confirmed Group sales growth1 Mid single digit sales growth Broadly in line with sales growth Core EPS growth1 excl. impact from resolution of tax disputes in 2023 Dividend outlook Further increase dividend in Swiss francs 1At Constant Exchange Rates (CER) 21
Slide 22: Finance
Finance Alan Hippe Chief Financial Officer
Slide 23: Q1 2024: Regional Pharma and Diagnostics sales bridge
Q1 2024: Regional Pharma and Diagnostics sales bridge CER Group sales increase of +2% +5% +11% +12% -45% +2% +2% -6% Pharma Division +2% +2% +272 -567 +215 +56 +56 +257 +233 -1,156 -923 1 United States Europe International Chugai Dia Division Group Fx ¹ Group (Japan) CER CHF Absolute values in CHFm
Slide 24: Pharma: Optimizing our manufacturing network
Pharma: Optimizing our manufacturing network Working on and protecting profitability Successful diversification and rejuvenation of Broadly stable manufacturing costs despite Pharma portfolio strong volume growth and diversification 60 180 +68% +20% Volume and COGS+PC development1 160 50 Sales devel
Slide 25: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact driven by the USD, JPY, CNY (APAC) and EUR -0.7%p +1.6% -1.4%p CER CHF sales growth -2.6%p sales growth YTD Mar 2024 YTD Mar 2024 vs. vs. YTD Mar 2023 YTD Mar 2023 -6.0% -0.5%p -1.3%p -0.5%p -0.6%p CER EUR APAC USD LATAM JPY Other Other CHF Europe
Slide 26: Expected 2024 currency impact
Expected 2024 currency impact USD / CHF Assumed avg. YTD 2024 -6% -3% -1% 0% Assuming the 29 March 2024 exchange rates remain stable 0.93 until end of 2024, 0.91 0.90 0.90 2024 impact1 is expected to be (%p): 0.87 0.89 0.89 0.89 Q1 Q2 Q3 Q4 0.86 0.88 0.89 0.90 0.90 0.90 0.90 0.90 0.90 0.90 0.90 0.90
Slide 27: 2024 outlook confirmed
2024 outlook confirmed Group sales growth1 Mid single digit sales growth Broadly in line with sales growth Core EPS growth1 excl. impact from resolution of tax disputes in 2023 Dividend outlook Further increase dividend in Swiss francs 1At Constant Exchange Rates (CER) 27
Slide 28: Diagnostics: New customer area structure 2024
Diagnostics: New customer area structure 2024 Changes effective 1 Jan, 2024, comparative information for 2023 has been restated accordingly Pharma Division FMI Diagnostics Division Diagnostics Division Core Lab Core Lab Molecular Lab 1 Molecular Lab Pathology Lab 2 Near Patient Care Point of Care Pa
Slide 29: Restatements to be applied in 2024
Restatements to be applied in 2024 Foundation Medicine shifted to the Diagnostics Division effective 1 Jan, 2024 Income statement (Core) Half Year 2023 Full Year 2023 Pharmaceuticals Division - CHFm Published Delta Restated Published Delta Restated Sales 22,681 -170 22,511 44,612 -347 44,265 Other r
Slide 30: Upcoming Roche IR events 2024
Upcoming Roche IR events 2024 Additional events driven by readouts Diagnostics Day Oncology/ASCO Ophthalmology/ASRS Pharma Day May 22 May 31 Jul 23 Sep 30 • Deep-dive into the current • Oncology solid tumors pipeline • Ophthalmology franchise • Update on Group & Pharma product portfolio update (tira
Slide 31: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 32: Q1 2024: Pharmaceuticals sales
Q1 2024: Pharmaceuticals sales All regions ex-Japan delivering strong growth, Japan impacted by Ronapreve sales in Q1 2023 2024 2023 Change in % CER w/o CHFm CHFm CHF CER Ronapreve Pharmaceuticals Division 10,921 11,608 -6 2 7 United States 5,692 5,763 -1 5 5 Europe 2,200 2,071 6 11 11 Japan 649 1,3
Slide 33: Q1 2024: Young portfolio delivering strong growth
Q1 2024: Young portfolio delivering strong growth Phesgo now second strongest growth driver; Vabysmo excellent growth momentum continues Vabysmo 108% Phesgo 70% Ocrevus 8% Polivy 81% Hemlibra 8% Xolair 10% Xofluza 185% Gazyva 16% Columvi n/a Evrysdi 7% Enspryng 37% Alecensa 4% Tecentriq 1% Lunsumio
Slide 34: US filing for inavolisib in 1L PIK3CA-mut HR+ BC completed
Oncology solid tumors US filing for inavolisib in 1L PIK3CA-mut HR+ BC completed Strong Phesgo launch continues, conversion rate climbing to 41%* Others Q1 update Avastin CHFm 146 / -10% CHFm 324 / -15% • Perjeta: Ongoing conversion to Phesgo, partially offset by growth in International Perjeta Alec
Slide 35: Polivy US patient share in 1L DLBCL climbing to 23%
Hematology Polivy US patient share in 1L DLBCL (IPI 0-5) climbing to 23% Positive Ph III (STARGLO) of Columvi in 2L+ DLBCL met primary endpoint of overall survival Columvi CHFm 25 / N/A Lunsumio Q1 update CHFm 16 / +21% • Hemlibra: Continued penetration across all approved patient Gazyva CHFm 213 /
Slide 36: Hemlibra: New convenience options planned for 2024/2025
Hematology Hemlibra: New convenience options planned for 2024/2025 Global SoC in Hemophilia A with extensive real-world data Hemlibra’s extensive clinical and real-world evidence base Sustained bleed protection ~80% of patients with Efficacy in RWD Vabysmo at ARVO*2024 (May 5-9) with low ABR (mean/m
Slide 37: EU filing of Elevidys in DMD planned for 2024
Neurology EU filing of Elevidys in DMD planned for 2024 Ocrevus market leader in US/EU5 with 24% global patient share Others Q1 update Enspryng CHFm 103 / +12% CHFm 65 / +37% • Ocrevus: Remaining #1 in new to brand in US; higher retention rate than other MS medicines Evrysdi • Evrysdi: Global market
Slide 38: Achieved US approval for Xolair in food allergy
Immunology Achieved US approval for Xolair in food allergy Gazyva Ph III (REGENCY) in lupus nephritis to readout in 2024 Q1 update Others • Xolair: Growth driven by strong CSU performance; market CHFm 233 / -19% shares in Asthma declining; food allergy launch commencing • Positive Ph III (OUtMATCH)
Slide 39: Xolair: First medicine to reduce allergic reactions to multiple foods
Immunology Xolair: First medicine to reduce allergic reactions to multiple foods Potential to redefine the way food allergies are managed Ph III (OUtMATCH) in food allergy1,* Primary endpoint Key secondary endpoints Difference, 60 Difference, 56 Difference, 67 Difference, 38 100 % of patients who co
Slide 40: Vabysmo US market share further expanding in nAMD and DME
Ophthalmology Vabysmo US market share further expanding in nAMD and DME Strong momentum for US launch of Vabysmo in RVO reaching 8% market share after only 4 months* Susvimo CHFm 1 / +11% Luxturna Q1 update Lucentis CHFm 1 / -61% • Vabysmo: Continued market share gains across early launch CHFm 49 /
Slide 41: Vabysmo improved anatomic results vs. aflibercept 8mg in NMA
Ophthalmology Vabysmo improved anatomic results vs. aflibercept 8mg in NMA Greater CST improvements vs aflibercept 2mg and 8mg after the monthly loading phase (week 12) Comparative efficacy of Vabysmo: A Systematic Literature Review and Network Meta-Analysis1 Mean difference in CST change from basel
Slide 42: Vabysmo: Real-world insights substantiate treatment benefits
Ophthalmology Vabysmo: Real-world insights substantiate treatment benefits Rapidly growing body of RWD confirming drying effect and durability seen in the pivotal studies Vabysmo’s growing real-world evidence base >10 FARETINA Selected RWD studies FARWIDE VOYAGER Vabysmo RWD Real-world data nAMD / D
Slide 43: Positive Ph II (KARDIA-2) for zilebesiran as add-on to SoC
Cardiovascular & Metabolism Positive Ph II (KARDIA-2) for zilebesiran as add-on to SoC Single SC dose showed clinically significant reduction in 24h mean ambulatory and office SBP at 3 months Ph II (KARDIA-2) results in hypertension1 Primary endpoint: Change in baseline to month 3 in Secondary endpo
Slide 44: 2024: Key newsflow
2024: Key newsflow* Compound Indication Milestone Alecensa Adjuvant ALK+ NSCLC US/EU approval US inavolisib + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC US/EU filing US Tecentriq Subcutaneous administration US/EU approval EU crovalimab PNH US/EU approval Elevidys DMD EU filing Ocrevus 6m SC RMS/
Slide 45: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 46: Q1 2024: Diagnostics Division sales
Q1 2024: Diagnostics Division sales Strong base business growth more than offsetting decline in COVID-19 sales 2024 2023 Change in % Excl. CHFm CHFm CHF CER C191 Diagnostics Division 3,478 3,714 -6 2 8 Core Lab 1,925 1,928 0 9 2 Molecular Lab 620 683 -9 -3 3 Near Patient Care 570 774 -26 -20 Patholo
Slide 47: Q1 2024: Diagnostics highlights
Q1 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 (-72%) Molecular Lab1 -3% • Blood Screening (+11%) • Virology base busi
Slide 48: Q1 2024: Diagnostics regional sales
Q1 2024: Diagnostics regional sales Strong base business growth across all regions North America -1% EMEA ~30% of divisional sales +2% ~34% of divisional sales Asia Pacific Latin America +1% +14% ~29% of divisional sales ~7% of divisional sales Base business=excluding COVID-19-related products; Grow
Slide 49: Largest installed base with significant growth potential
Largest installed base with significant growth potential +3% SWA analytical units of which: cobas® pro / pure +77% +2% Lab SW Solutions +14% Preanalytics / Connectivity HE600 +12% BenchMark ULTRA/ +20% cobas® 5800/6800/8800 ULTRAPLUS +10% DP200/DP600 +29% +6% cobas® Liat 2023 Growth rates – from 31.
Slide 50: Accu-Chek SmartGuide CGM solution
Accu-Chek SmartGuide CGM solution Enabling better decision-making for people with diabetes Accu-Chek SmartGuide CGM solution Improving diabetes management and care continuum • Data released at ATTD shows strong performance of first Roche CGM • 14 days of reliable and accurate real-time glucose senso
Slide 51: FDA approval for cobas malaria test
FDA approval for cobas® malaria test First molecular donor screening test to protect the blood supply from malaria infection Unmet medical need and medical value • Transfusion-transmitted malaria infection can cause serious complications and death in recipients • Increases blood safety in endemic co
Slide 52: FDA BDD granted for pTau217 blood test
FDA BDD granted for pTau217 blood test1 Alzheimer’s blood tests will substantially improve disease diagnosis Elecsys CSF ratios Elecsys Amyloid Plasma Panel Rule-in blood test2 • tTau, pTau181 & Abeta42 • Biomarkers pTau181 & ApoE4p • Biomarker pTau217 • Sensitivity 90%±3% • Minimize false negatives
Slide 53: 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 54: Invitation to Roche Diagnostics Investor Day 2024
Invitation to Roche Diagnostics Investor Day 2024 Innovating Diagnostics, shaping healthcare, changing lives Highlights: • Deep-dive into the current product portfolio • Updates on key development projects and upcoming launches, including mass spectrometry, CGM, NGS Presenters include: • Matt Sause,
Slide 55: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 56: Changes to the development pipeline
Changes to the development pipeline Q1 2024 update New to phase I New to phase II New to phase III New to registration 2 AIs: 1 AI (US): RG6058 tiragolumab + Tecentriq - NSCLC adj. RG3625 TNKase - stroke RG7716 Vabysmo - myopic choriodial neovascularization (CNV) Removed from phase I Removed from ph
Slide 57: Roche Group development pipeline
Roche Group development pipeline Phase I (48 NMEs + 8 AIs) Phase II (20 NMEs + 10 AIs) RG6026 Columvi monotherapy + combos heme tumors CHU glypican-3 x CD3 solid tumors tiragolumab + T NSCLC RG6058 tiragolumab combos solid tumors CHU codrituzumab HCC RG6058 tiragolumab + T + chemo NSCLC periadjuvant
Slide 58: Roche Group development pipeline
Roche Group development pipeline Phase III (9 NMEs + 40 AIs) Registration US & EU (1 NME + 6 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG6107* PiaSky (crovalimab) PNH Columvi + chemo 2L+ DLBCL RG6299 ASO factor B IgA nephropathy RG7446 Tecentriq SC1 all approved indication
Slide 59: Expected regulatory submissions: New Molecular Entities
Expected regulatory submissions* New Molecular Entities: Lead and additional indications anti-latent myostatin + giredestrant New Molecular Entity (NME) Cardiovascular & Metabolism RG6171 RG6237 Evrysdi endometrial cancer SMA Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology g
Slide 60: Expected regulatory submissions: Marketed products
Expected regulatory submissions* Marketed products: Additional indications New Molecular Entity (NME) Cardiovascular & Metabolism Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology Immunology Other Infectious Diseases Lunsumio + lenalidomide RG7828 2L FL+ Lunsumio + Polivy ✓ In
Slide 61: Major pending approvals 2024
Major pending approvals 2024 US EU China Japan-Chugai Tecentriq SC PiaSky (crovalimab) Vabysmo Alecensa RG7446 all approved indications RG6107 PNH RG7716 BRVO/CRVO RG7853 ALK+ NSCLC adj Filed Nov 2022 Filed June 2023 Filed March 2023 Filed Dec 2023 PiaSky (crovalimab) Vabysmo Ocrevus Evrysdi RG6107
Slide 62: Major granted approvals 2024
Major granted approvals 2024 US EU China Japan-Chugai Xolair Tecentriq SC PiaSky (crovalimab) PiaSky (crovalimab) RG3648 Food allergy RG7446 all approved indications RG6107 PNH RG6107 PNH Feb 2024 Jan 2024 Feb 2024* March 2024 Alecensa Vabysmo RG7853 ALK+ NSCLC adj *First worldwide appoval RG7716 BR
Slide 63: Doing now what patients need next
Doing now what patients need next