Roche Holding Ltd · SIX:RO
Roche — Q1 2023 Earnings Presentation
58 slides from Roche's earnings presentation, Apr 26, 2023
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 Q1 2023 sales
Roche Q1 2023 sales Basel, 26 April 2023
Slide 4: Group: Thomas Schinecker, Chief Executive Officer
Group Thomas Schinecker Chief Executive Officer
Slide 5: Q1 2023 performance; Outlook
Q1 2023 performance Outlook
Slide 6: Q1 2023: Strong underlying sales excluding COVID-19 decline
Q1 2023: Strong underlying sales excluding COVID-19 decline Group sales -3% driven by expected decline in COVID-19 testing • Strong Pharma performance (+9%) driven by ongoing portfolio rejuvenation • Good Diagnostics base business growth (+4%) • COVID-19 sales decline in line with FY 2023 expectatio
Slide 7: Q1 2023: Group sales decline driven by COVID-19 sales erosion
Q1 2023: Group sales decline driven by COVID-19 sales erosion 2023 2022 Change in % Excl. 1 CHFbn CHFbn CHF CER C19 Pharmaceuticals Division 11.7 11.2 5 9 9 Diagnostics Division 3.6 5.3 -31 -28 4 Roche Group 15.3 16.4 -7 -3 8 CER=Constant Exchange Rates; totals may include differences due to roundin
Slide 8: Q1 2023: Portfolio diversification ongoing
Q1 2023: Portfolio diversification ongoing CHFm -3% at CER Diversification of Roche portfolio +146 +48 Q1 2018 Q1 2023 CHF 13.6bn CHF 15.3bn -1’626 +1’262 -333 -620 16’445 15’322 Diagnostics Neuroscience Oncology Other pharma Hemophilia A Immunology Ophthalmology Infectious diseases AHR Q1 2022 Dia
Slide 9: Q1 2023: Strong underlying growth in Pharma and Diagnostics
Q1 2023: Strong underlying growth in Pharma and Diagnostics Pharma Diagnostics Quarterly sales evolution 2022-2023 Quarterly sales evolution 2022-2023 % CER % CER +30% +30% +24% +20% +20% +7% +8% +10% +9% +9% +3% +4% +10% +10% +6% +4% +9% +0% -2% +3% 0% +0% +2% 0% -10% -4% -9% -10% -6% -20% -28% -20
Slide 10: Portfolio rejuvenation progressing; new launches with >50% of sales
Portfolio rejuvenation progressing; new launches with >50% of sales Columvi (glofitamab): first NME launch in 2023* CHFm % of Pharma Sales*** 7,000 50% 6,000 5,000 42% 4,000 31% 3,000 22% 2,000 1,000 0 Q1 2020 Q1 2021 Q1 2022 Q1 2023 Cotellic Alecensa Tecentriq Ocrevus Hemlibra Luxturna Xofluza Poli
Slide 11: 2023 performance; Outlook
2023 performance Outlook
Slide 12: 2023: Upcoming newsflow
2023: Upcoming newsflow Pharma Diagnostics Tiragolumab + Tecentriq in 1L PDL1+ NSCLC Glofitamab + GemOx in 2L+ DLBCL Modular transportation system, integrated CCM Vertical into existing cobas connection modules Tiragolumab + Tecentriq + chemo in 1L Lunsumio + Polivy in 2L+ DLBCL* Esophageal Flexible
Slide 13: Corporate Executive Committee
Corporate Executive Committee Since April 2023 *Co-chair late stage pipeline committee (LSPC); pRED=Pharma Research & Early Development; gRED=Genentech Research & Early Development 13
Slide 14: 2023 sales outlook
2023 sales outlook Sales drivers1 Pharma: Key products with strong growth and momentum from ongoing launches Diagnostics: Base business with solid growth Group sales growth1 Low single digit decline COVID-19 sales for Diagnostics and Pharma expected to decline by roughly CHF 5bn AHR2 sales expected
Slide 15: 2023 outlook
2023 outlook Group sales growth1 Low single digit decline Core EPS growth1 Broadly in line with sales decline Dividend outlook Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 15
Slide 16: Pharmaceuticals Division: Teresa Graham
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 17: Q1 2023: Pharmaceuticals Division sales
Q1 2023: Pharmaceuticals Division sales All regions delivering strong growth 2023 2022 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 11,699 11,159 5 9 United States 5,853 5,489 7 6 Europe 2,071 2,072 0 5 Japan 1,390 1,337 4 18 International 2,385 2,261 5 13 CER=Constant Exchange Rates 17
Slide 18: Q1 2023: Strong momentum for key growth drivers
Q1 2023: Strong momentum for key growth drivers Vabysmo leading growth contributor after only 5 quarters Vabysmo >500% Ocrevus 14% Hemlibra 24% Evrysdi 62% Tecentriq 15% Perjeta 11% Phesgo 72% Tamiflu >500% Polivy 96% TNKase / Activase 23% Ronapreve 9% Gazyva 24% Alecensa 9% Kadcyla 5% Xolair 5% Xof
Slide 19: Q1 2023: Oncology portfolio growing +4%
Q1 2023: Oncology portfolio growing +4% YoY CER growth Phesgo (+72%) HER2 franchise HER2 franchise Herceptin Perjeta (+11%) +6% • Kadcyla (+5%) with growth ex-US in adj. BC; China NRDL listing granted Kadcyla (+5%) • Perjeta (+11%) driven by US & International Tecentriq +15% Polivy (+96%) • Phesgo (
Slide 20: Polivy in 1L DLBCL: FDA approval granted
Polivy in 1L DLBCL: FDA approval granted Comprehensive NHL development program ongoing Uptake in 1L DLBCL accelerating NHL development program progressing 1L DLBCL approved in >70 countries Polivy quarterly sales Indication Regimen Ph I Ph II Ph III YoY CER growth CHF Mn +96% 2L+ DLBCL (SCT ineligib
Slide 21: Phesgo: Conversion rate in early launch countries climbing to 35%
Phesgo: Conversion rate in early launch countries climbing to 35% Phesgo reduces administration time & costs Phesgo with strong global launch Global Phesgo conversion rate** 40% 35% 30% 20% 10% Phesgo 0% Q4’20 Q1’21 Q2’21 Q3’21 Q4’21 Q1’22 Q2’22 Q3’22 Q4’22 Q1’23 • 85% of patients preferred Phesgo f
Slide 22: Divarasib in CRC: Positive early combination data at AACR
Divarasib in CRC: Positive early combination data at AACR Potential for best-in-class profile Divarasib (KRAS G12Ci) Ph Ib results for divarasib + cetuximab in advanced or metastatic CRC in vitro proliferation assay ORR results Best SLD Change from Baseline (%) Divarasib Sotorasib Adagrasib • Irreve
Slide 23: Tecentriq: Solid growth across all regions
Tecentriq: Solid growth across all regions First PD-(L)1 with pivotal SC results filed and PDUFA set for September 15th CHFm YoY CER growth Q1 update 1,100 • Ph III (IMbrave050) results in adjuvant HCC presented at AACR; 1,000 +15% RFS primary endpoint met but OS immature 900 +8% • Ph III (IMpassion
Slide 24: Hemophilia A: Hemlibra the global standard of care
Hemophilia A: Hemlibra the global standard of care 37% US/EU-5 patient share reached CHFm YoY CER growth Q1 update 1,200 • ~20,000 patients treated globally +24% • Hemlibra continues to penetrate across all approved patient 1,000 segments +30% • EU: Label extension to moderate patients (HAVEN 6) gra
Slide 25: Crovalimab: Positive Ph III results in PNH
Crovalimab: Positive Ph III results in PNH Expanding into additional diseases: Ph I in LN initiated Ph III (COMMODORE 3) results in PNH Crovalimab development program Normalization of LDH Indication Ph I Ph II Ph III COMPOSER Paroxysmal COMMODORE 1 (switch) PNH nocturnal hemoglobinuria COMMODORE 2 (
Slide 26: Immunology: Actemra COVID-19 sales declining and Esbriet LOE
Immunology: Actemra COVID-19 sales declining and Esbriet LOE Xolair autoinjector approval and Ph III food allergy readout expected in 2023 Q1 updates CHFm YoY CER growth • Ph III (REGENCY) Gazyva in LN fully recruited; read out expected in 2024 • Ph III (INShore) Gazyva in PNS initiated 2,500 +9% Ac
Slide 27: Multiple Sclerosis: Ocrevus reaching 22% patient share
Multiple Sclerosis: Ocrevus reaching 22% patient share Ph III results for 6M SC Ocrevus expected in 2023 CHFm YoY CER growth Q1 update 1,750 +14% +18% • >300k patients treated globally 1,500 • #1 treatment in US and EU-5, both in total share and new to +16% 1,250 +38% brand share 1,000 • Higher rete
Slide 28: Spinal Muscular Atrophy: Evrysdi market leader in US and Japan
Spinal Muscular Atrophy: Evrysdi market leader in US and Japan Increasing penetration in treatment-naive patient segment CHFm YoY CER growth Q1 update 450 • >8,500 patients treated worldwide; retention rate in first 12 400 +62% months of ~90% globally 350 • US: Growth driven by switch and naive pati
Slide 29: Evrysdi: 4 year data reinforce strong efficacy and safety profile
Evrysdi: 4 year data reinforce strong efficacy and safety profile Ph II/III (SUNFISH) results in SMA Ph II/III (SUNFISH) safety in SMA 3 Motor function score 900 AE rates SUNFISH Part 1 800 SUNFISH Part 2 Mean change from baseline 2 in MFM32 total score*† 700 1 600 AEs per 100PY* 0 500 -1 400 -2 300
Slide 30: Ophthalmology: Excellent Vabysmo launch continues
Ophthalmology: Excellent Vabysmo launch continues Double-digit US market share in nAMD and mid single-digit in DME* Angiogenesis 2023 Q1 update CHFm YoY CER growth Vabysmo 500 >500% • US: Strong uptake with switches primarily from aflibercept; use in 400 naive patients further accelerating • >860k v
Slide 31: Vabysmo: Positive results in RVO presented at Angiogenesis 2023
Vabysmo: Positive results in RVO presented at Angiogenesis 2023 Improvement in macular leakage compared to aflibercept Ph III (BALATON/COMINO) results in RVO BCVA1 CST2 Macular leakage3 A flib e r c e p t 2 .0 m g (n = 2 7 7 ) F a r ic im a b 6 .0 m g (n = 2 7 6 ) 100% A flib e r c e p t 2 .0 m g (n
Slide 32: 2023: Key late-stage news flow
2023: Key late-stage news flow* Compound Indication Milestone Hemlibra Moderate hemophilia A EU approval Polivy + R-CHP 1L DLBCL US approval Vabysmo RVO US approval/EU filing Regulatory Tecentriq Subcutaneous administration US approval/EU filing EU filing Columvi (glofitamab) 3L+ DLBCL US/EU approva
Slide 33: Diagnostics Division: Matt Sause
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 34: Q1 2023: Diagnostics Division sales
Q1 2023: Diagnostics Division sales Good base business growth, partially offsetting COVID-19 sales decrease 2023 2022 Change in % CHFm CHFm CHF CER Diagnostics Division 3,623 5,286 -31 -28 Core Lab 1,928 1,896 2 7 Molecular Lab 593 1,189 -50 -48 Point of Care 397 1,466 -73 -72 Diabetes Care 376 417
Slide 35: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Good base business growth in Q1 2023 55% 48% 31% 24% 17% 18% 9% 10% 8% 7% 3% 4% 11% 8% 0% -4% Diagnostics Division sales growth -9% Base business sales growth1 -28% Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 1.2bn 1.3bn 1.0bn 1.2bn 1.9bn 1.2bn
Slide 36: Q1 2023: Diagnostics Division highlights
Q1 2023: Diagnostics Division highlights Good base business growth, partially offsetting COVID-19 sales decrease CHFbn YoY CER growth • Immunodiagnostics (+9%) Core Lab +7% • Clinical Chemistry (+9%) • Custom biotech (-9%) • Virology base business (+12%) • Blood Screening (+15%) Molecular Lab -48% •
Slide 37: Q1 2023: Diagnostics Division regional sales
Q1 2023: Diagnostics Division regional sales Strong base business growth across all regions impacted by lower COVID-19 sales North America -39% EMEA ~28% of divisional sales -30% ~35% of divisional sales Asia Pacific Latin America -15% -8% ~30% of divisional sales ~7% of divisional sales Growth rate
Slide 38: Largest installed base worldwide with significant growth potential
Largest installed base worldwide with significant growth potential +4% cobas® 4000/6000/80001 +122% cobas® pro / pure +3% Lab SW Solutions +9% Preanalytics / Connectivity HE600 +12% +30% cobas® 5800/6800/8800 BenchMark ULTRA/ ULTRAPLUS +10% +7% LightCycler / MagnaPure DP200/DP600 +29% +24% cobas® Li
Slide 39: Core Lab menu expansion driving future growth
Core Lab menu expansion driving future growth >240 assays running on >100k installed cobas® serum work area instruments Launches in 2021, 2022 and upcoming4 Immuno chemistry assays Clinical chemistry assays EBV EBNA IgG (CE) IGRA SARS-CoV-2 (CE) Anti-HEV IgG and Anti-HEV Fentanyl3 (CE, US) Benz 22 (
Slide 40: navify Marketplace and Algorithm Suite
navify Marketplace and Algorithm Suite Roll-out of two new digital solutions which will drive operational and clinical excellence Customer base Customer access to Portal/Marketplace2 Access to applications3 navify Algorithm Suite navify Inventory Roche instruments 3rd party devices cobas infinity Ce
Slide 41: VENTANA FOLR1 (FOLR1-2.1) RxDx assay
VENTANA FOLR1 (FOLR1-2.1) RxDx assay First FDA approved FOLR1 companion diagnostic test for ovarian cancer chemo or First Line chemo + bevacizumab • 322k estimated cases of ovarian cancer worldwide Treatment (2021)1 Progression for 80% of patients • First FDA-approved IHC companion diagnostic test f
Slide 42: Diagnostics key launches 2023
Diagnostics key launches 2023 Area Product Description Markets Status Modular transportation system, integrated into the existing cobas connection modules, allowing for overhead CCM Vertical Global sample transportation over different work areas or different floors enabling effective use of lab spac
Slide 43: Finance: Alan Hippe, Chief Financial Officer
Finance Alan Hippe Chief Financial Officer
Slide 44: Q1 2023: Highlights
Q1 2023: Highlights Sales • Group sales decline of -3% resulting from erosion of COVID-19 related sales • Solid Pharma and Diagnostics underlying business growth Currency impact on sales • Negative currency impact of -4%p primarily by the JPY, EUR and CNY Growth rates at CER (Constant exchange Rates
Slide 45: Q1 2023: Regional Pharma and Group sales bridge
Q1 2023: Regional Pharma and Group sales bridge +6% +5% +13% +18% -28% -3% -7% Pharma Division -28% +9% +224 +101 +286 +366 -1,480 -503 -1,123 -620 1 United States Europe Intl. Chugai Dia Division Group Fx ¹ Group (Japan) CHF Absolute values in CHFm at Constant Exchange Rates (avg full year 2022); 1
Slide 46: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact driven by the JPY, EUR and CNY -3.1% -0.7p -6.8% CER -0.9p +0.1p CHF sales growth sales growth Q1 2023 -0.4p Q1 2023 vs. -1.2p vs. Q1 2022 Q1 2022 -0.2p -0.4p CER EUR APAC USD LATAM JPY Other Other CHF Europe CER = Constant Exchange Rates (avg ful
Slide 47: Expected 2023 currency impact
Expected 2023 currency impact CHF / USD Assumed avg. YTD 2023 0% -3% -4% -4% 0.94 0.95 0.95 Assuming the 31 March 2023 exchange rates remain 0.92 stable until end of 2023, 2023 impact1 is expected to be (%p): 0.93 0.92 0.92 0.92 Q1 HY Sep FY 0.92 0.92 0.93 0.91 0.91 0.91 0.91 0.91 0.91 0.91 0.91 0.9
Slide 48: 2023 outlook
2023 outlook Group sales growth1 Low single digit decline Core EPS growth1 Broadly in line with sales decline Dividend outlook Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 48
Slide 49: Upcoming virtual ESG IR event on environmental sustainability
Upcoming virtual ESG IR event on environmental sustainability Roche ESG Event on May 23 Environmental Sustainability 15:30 - 17:00 CEST / 14:30 – 16:00 BST 09:30 – 11:00 am EDT / 6:30 – 8:00 am PDT 49
Slide 50: Doing now what patients need next
Doing now what patients need next
Slide 51: 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 52: Changes to the development pipeline
Changes to the development pipeline Q1 2023 update New to phase I New to phase II New to phase III New to registration 1AI: 2 NMEs: 1 NME: RG6107 crovalimab - lupus nephritis RG6501 OpRegen – geographic atrophy RG6149 astegolimab (Anti-ST2) – COPD RG6341 NME – chronic cough 1 AI: 1 AI: RG7159 Gazyva
Slide 53: Roche Group development pipeline
Roche Group development pipeline Phase I (50 NMEs + 12 AIs) Phase II (23 NMEs + 9 AIs) RG6007 HLA-A2-WT1 x CD3 AML RG7802 cibisatamab ± T solid tumors RG6026 Columvi (glofitamab) + chemo 1L ctDNA high risk DLBCL Columvi (glofitamab) RG7827 FAP-4-1BBL monotherapy + combos solid tumors tiragolumab + T
Slide 54: Roche Group development pipeline
Roche Group development pipeline Phase III (9 NMEs + 40 AIs) Registration US & EU (1 NME + 3 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG3648 Xolair food allergy RG6026 Columvi (glofitamab) 3L+ DLBCL RG6026 Columvi (glofitamab) + chemo 2L+ DLBCL RG6149 astegolimab (Anti-ST2) COPD RG7446 Tecentriq
Slide 55: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III Columvi (glofitamab) + divarasib balovaptan RG6026 chemo RG6330 (KRAS G12 C) RG7314 post-traumatic stress 1L ctDNA+ high risk DLBCL 2L NSCLC disorder tiragolumab + T astegolimab alogabat RG6058 1L PD-L1+ cervical RG6149 (a
Slide 56: AI submissions for existing products
AI submissions for existing products Projects in phase II and III New Molecular Entity (NME) Metabolism Additional Indication (AI) Neuroscience Oncology / Hematology Ophthalmology Immunology Other Infectious Diseases Tecentriq + Avastin Kadcyla + Tecentriq RG7446 RG3502 HCC adj HER-2+ eBC high-risk
Slide 57: Major pending approvals 2023
Major pending approvals 2023 US EU China Japan-Chugai Tecentriq SC Evrysdi Evrysdi Phesgo RG7446 all approved indications RG7916 SMA presymptomatic pediatric <2mo RG7916 SMA presymptomatic pediatric <2mo RG6264 HER-2+ BC/CC Filed Nov 2022 Filed Nov 2021 Filed June 2022 Filed Sept 2022 Columvi (glofi
Slide 58: Major granted approvals 2023
Major granted approvals 2023 US EU China Japan-Chugai Polivy Xofluza Polivy RG7596 1L DLBCL (US) RG6152 influenza pediatric RG7596 1L DLBCL April 2023 Jan 2023 Jan 2023 Hemlibra Polivy RG6013 moderate hemophilia A RG7596 r/r DLBCL Jan 2023 Jan 2023 Xofluza RG6152 influenza pediatric 5 to <12 years M