Roche Holding Ltd · SIX:RO
Roche — Q1 2022 Earnings Presentation
59 slides from Roche's earnings presentation, Apr 25, 2022
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 2022 Sales
Roche Q1 2022 Sales Basel, 25 April 2022
Slide 4: Group
Group Severin Schwan Chief Executive Officer
Slide 5: Q1 2022 performance; Outlook
Q1 2022 performance Outlook
Slide 6: Q1 2022: Strong performance for Pharma and Diagnostics
Q1 2022: Strong performance for Pharma and Diagnostics Strong Group sales +11% driven by both divisions • Pharma performing well (+6%) and delivering on current products and new launches • Diagnostics maintaining growth momentum (+24%) including strong base business growth (+10%) Portfolio rejuvenat
Slide 7: Q1 2022: Group sales growth driven by strong performance in both divisions
Q1 2022: Group sales growth driven by strong performance in both divisions 2022 2021 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 11.2 10.6 5 6 Diagnostics Division 5.3 4.3 22 24 Roche Group 16.4 14.9 10 11 CER=Constant Exchange Rates; totals may include differences due to rounding 7
Slide 8: Q1 2022: Group sales +11% driven by both divisions
Q1 2022: Group sales +11% driven by both divisions 16% 14%* 14% 13% 12% 12% 10% 9% 9% 11% 8% 7% 7% 7% 6% 6% 6% 6% 6% 6% 7% 8% 8% 4% 6% 4% 5% 5% 4% 4% 3% 2% 3% 3% 1% 1% 0% -2% -4% -6% -4% AHR1 impact -8% -10% COVID-19 impact Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q
Slide 9: Q1 2022: Strong underlying business momentum
Q1 2022: Strong underlying business momentum +11% at CER CHFm Diversification of Roche business +449 -568 + 749 -155 Q1 2017 Q1 2022 + 304 +736 CHF 12.9bn CHF 16.4bn AHR AHR 16,445 14,930 Diagnostics Oncology Other pharma AHR Ophthalmology Neuroscience Infectious diseases Hemophilia A Q1 Diagnostics
Slide 10: Q1 2022 performance; Outlook
Q1 2022 performance Outlook
Slide 11: 2022 sales outlook confirmed
2022 sales outlook confirmed Sales drivers1 Pharma: New products with accelerating growth Diagnostics: Base business with strong growth • Guidance stable to low-single digit group sales growth • Group sales to grow high-single digit if COVID-19 sales and AHR AHR2 biosimilars: Roughly CHF -2.5 bn sal
Slide 12: 2022: Upcoming newsflow
2022: Upcoming newsflow Pharma Diagnostics Vabysmo in DME/nAMD Automated BenchMark immunohistochemistry/in situ Susvimo in nAMD ULTRA PLUS hybridization advanced staining Ongoing and platform upcoming Polivy in 1L DLBCL launches High capacity pathology slide mosunetuzumab in FL Upcoming DP600 scanne
Slide 13: First Roche ESG event focusing on access to healthcare
First Roche ESG event focusing on access to healthcare Our 10-year ambitions to be achieved by 2030 Pharmaceuticals: Double medical advances at less costs to society Roche ESG Event on May 16 Access to Healthcare Diagnostics: Double patient access to novel, high-medical-value diagnostics solutions 1
Slide 14: 2022 outlook
2022 outlook Group sales growth1 • Stable to low-single digit • Low- to mid-single digit (including accretion of Core EPS growth1 4.4%p from share repurchase) Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 14
Slide 15: Pharmaceuticals Division
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 16: Q1 2022: Pharmaceuticals Division sales
Q1 2022: Pharmaceuticals Division sales Good growth momentum 2022 2021 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 11,159 10,600 5 6 United States 5,489 5,292 4 2 Europe 2,072 2,175 -5 -1 Japan 1,337 852 57 69 International 2,261 2,281 -1 0 CER=Constant Exchange Rates 16
Slide 17: Q1 2022: Continued Pharma portfolio rejuvenation
Q1 2022: Continued Pharma portfolio rejuvenation Ronapreve 272% Ocrevus 18% Hemlibra 30% Evrysdi 189% Phesgo 410% Alecensa 23% Tecentriq 8% Kadcyla 9% Polivy 89% Xolair 9% Enspryng 216% Actemra / RoActemra 3% Vabysmo n/a Perjeta 1% Gazyva 7% Esbriet -6% US TNKase / Activase -20% Europe Lucentis -26%
Slide 18: Q1 2022: Oncology portfolio rejuvenation progressing well
Q1 2022: Oncology portfolio rejuvenation progressing well YoY CER growth HER2 franchise Phesgo (+410%) • Kadcyla (+9%) with growth ex-US due to adjuvant BC HER2 franchise Herceptin Perjeta (+1%) +1% • Perjeta (+1%) growth cannibalized by successful Phesgo launch Kadcyla (+9%) Tecentriq +8% • Phesgo
Slide 19: HER2 franchise: Phesgo with strong global launch
HER2 franchise: Phesgo with strong global launch Perjeta conversion rate approaching 25% in early launch countries Phesgo cutting administration time & costs Global Perjeta conversion rate** 24% Volume (vials) Phesgo • Phesgo administration results in significantly reduced healthcare costs and resou
Slide 20: Tecentriq overview: Adjuvant program to read out in 2022
Tecentriq overview: Adjuvant program to read out in 2022 Tecentriq Q1 update CHFm YoY CER growth • US: Sales still impacted by label changes 1,000 • Japan: Sales impacted by mandatory price cut +23% 900 Lung franchise (NSCLC, SCLC) +31% +17% +8% 800 +26% +49% +35% • EU: Growth driven by 1L SCLC; Pos
Slide 21: Hemophilia A franchise: Hemlibra accepted as new standard of care
Hemophilia A franchise: Hemlibra accepted as new standard of care 34% US/EU-5 patient share reached CHFm YoY CER growth 1,000 Hemophilia Q1 update 900 +38% +30% • Nearly 17,000 patients currently treated globally 800 +37% +33% +58% • Hemlibra continues to penetrate across all approved 700 +57% +45%
Slide 22: Immunology franchise: Still moved by COVID-19
Immunology franchise: Still moved by COVID-19 CHFm YoY CER growth Immunology Q1 update 2,500 +6% +9% Actemra (+3%) -5% -2% 2,000 • Remains leading RA monotherapy in EU-5 • Shift from IV to SC continues with SC sales accounting for 1,500 >50% 1,000 • Around 50% of IV sales expected to be due to COVID
Slide 23: MS franchise: Ocrevus global market share reaches 20%
MS franchise: Ocrevus global market share reaches 20% CHFm YoY CER growth 1,500 +18% Q1 update +7% +25% 1,250 +37% +16% +31% • US/EU still impacted by COVID-19 +38% +55% +12% +10% • Mitigation plans for late stage MS development programs 1,000 +48% 67% +59% initiated due to situation in Ukraine/Russ
Slide 24: SMA franchise: Evrysdi with strong US and EU launches
SMA franchise: Evrysdi with strong US and EU launches Most prescribed treatment in the US with >20% share; Germany with >30% share CHFm YoY CER growth 250 Q1 update +189% +347% • ~5,000 patients treated world wide (commercial, clinical 200 trials, compassionate use) >500% 150 • US: Growth driven by
Slide 25: SMA franchise: New data in presymptomatic SMA
SMA franchise: New data in presymptomatic SMA Indication extension for <2 months of age filed with FDA and EMA Ph II (RAINBOWFISH): 1 year interim results in infants (<2 months of age) 4 infants with 2 SMN2 copies: • Most infants treated for >12 months achieved near-maximum CHOP-INTEND scores • Most
Slide 26: Ophthalmology franchise: Follow-up data for Vabysmo in DME
Ophthalmology franchise: Follow-up data for Vabysmo in DME Proportion of patients achieving Q16W dosing increases to ≥ 60% at week 96 Ph III (YOSEMITE, RHINE) in DME: Dosing intervals of patients at year 1 and 2 52 weeks 96 weeks YOSEMITE RHINE YOSEMITE RHINE • Anti-VEGF/Ang2 bispecific mAb with new
Slide 27: Ophthalmology franchise: Follow-up data for Susvimo in nAMD
Ophthalmology franchise: Follow-up data for Susvimo in nAMD Vision and anatomical outcomes maintained through year 2 Ph III (ARCHWAY) in nAMD: 2-year results for Susvimo Q24W dosing BCVA change from baseline CPT change from baseline • First eye implant with continuous drug delivery offering 6-month
Slide 28: 2022: Key late-stage newsflow and upcoming IR events
2022: Key late-stage newsflow* and upcoming IR events Compound Indication Milestone Vabysmo nAMD/DME US/EU approval US Susvimo nAMD EU approval mosunetuzumab 3L+ FL US/EU approval Regulatory Tecentriq Adjuvant NSCLC EU approval Hemlibra Mild to moderate hemophilia A EU approval Polivy + R-CHP 1L DLB
Slide 29: Diagnostics Division
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 30: Q1 2022: Diagnostics Division sales
Q1 2022: Diagnostics Division sales Sales increase of +24% driven by COVID-19 testing and base business 2022 2021 Change in % CHFm CHFm CHF CER Diagnostics Division 5,286 4,330 22 24 Core Lab1 1,896 1,786 6 8 Point of Care1 1,466 806 82 84 Molecular Lab1 1,189 996 19 21 Diabetes Care 417 460 -9 -7 P
Slide 31: Q1 2022: Diagnostics Division regional sales
Q1 2022: Diagnostics Division regional sales Very strong growth in all regions; rapid antigen test sales contributing to US growth North America +59% EMEA1 ~32% of divisional sales +2% ~36% of divisional sales Asia Pacific Latin America +34% +9% ~27% of divisional sales ~5% of divisional sales Growt
Slide 32: Q1 2022: Diagnostics Division highlights
Q1 2022: Diagnostics Division highlights Strong growth despite a high base in Q1 2021 CHFbn YoY CER growth +8% • Immunodiagnostics (+11%) Core Lab1,3 • Clinical Chemistry (+8%) • POC Immunodiagnostics (+107%) Point of Care3 +84% • POC Molecular3 (+83%) Molecular Lab3 +21% • Virology (+31%) • Blood g
Slide 33: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Very strong COVID-19 and base business growth 55% 48% 1 Diagnostics Division sales growth 28% 31% Routine sales growth 1 24% 18% 17% 18% 8% 10% 5% 2% 11% 1% -2% 9% -5% Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 -17% COVID- Q1: 0.1bn Q2: 0.6bn Q
Slide 34: cobas 5800/6800/8800 molecular menu expansion driving growth
cobas® 5800/6800/8800 molecular menu expansion driving growth Further growing the installed base in 2022 Donor Screening Blood Borne Disease Sexual Health Transplant Respiratory Antimicrobial Stewardship MPX HIV-1 HPV CMV Flu A/B & RSV (OMNI) MTB-RIF/INH WNV HBV CT/NG EBV MTB C.diff DPX HCV TV/MG BK
Slide 35: Upcoming launch of cobas SARS-CoV-2 DUO
Upcoming launch of cobas® SARS-CoV-2 DUO Providing accurate diagnosis of SARS-CoV-2 infection for proper patient management Dual target PCR design concept for accurate quantification Dual target design in SARS-CoV-2 virus specific region, for robust • Provide qualitative result of SARS-CoV-2 detecti
Slide 36: TIB-Molbiol SARS-Cov-2 menu for tracking virus evolution
TIB-Molbiol SARS-Cov-2 menu for tracking virus evolution Detecting major variants in hours vs a week for sequencing BA.3 X.F BA.4 BA.5 BA.1 & BA1.1 Delta X.E BA2 & BA2.2 >10 tests to differentiate all relevant variants 36
Slide 37: Roche Serum Work Area menu expansion driving future growth
Roche Serum Work Area menu expansion driving future growth >240 assays running on >100k installed cobas® SWA instruments Broad IM + CC assay menu Launched in 2021 & upcoming launches in 2022 Immuno chemistry assays Clinical chemistry assays EBV EBNA IgG (CE) IGRA SARS-CoV-2 (CE) Fentanyl5 (CE, US) A
Slide 38: Alzheimer's disease IVD blood tests development
Alzheimer’s disease IVD blood tests development Enabling access to Alzheimer’s disease modifying therapies Non-AD patients1 Patients undergoing initial evaluation for • pTau 181 and ApoE4 have been selected based on clinical non-specific cognitive decline AD patients1 performance and robustness Step
Slide 39: Roche Analyst Event on Diagnostics Division at AACC 2022
Roche Analyst Event on Diagnostics Division at AACC 2022 Chicago, Palmer House hotel, July 26, 6-7:15pm CDT AACC = Annual Scientific Meeting and Clinical Lab exposition 39
Slide 40: Key launches 2022
Key launches 2022 Area Product Description Market Automated immunohistochemistry/in situ hybridization (ISH) advanced staining platform with BenchMark ULTRA PLUS US & CE Pathology Lab enhanced software capabilities, workflow and testing efficiency DP600 High capacity pathology slide scanner for high
Slide 41: Finance
Finance Alan Hippe Chief Financial Officer
Slide 42: Q1 2022: Highlights
Q1 2022: Highlights Sales • Group sales growth of +11% due to strong performance in Pharmaceuticals and Diagnostics division • Pharma delivering well across entire portfolio; Diagnostics continuing with strong results in double-digit range Currency impact on sales • Slightly negative currency impact
Slide 43: Q1 2022: Group Sales
Q1 2022: Group Sales CER Group sales increase of +11% driven by Diagnostics Division & Chugai (Ronapreve) +2% -1% 0% +69% +24% +11% +10% Pharma Division +24% +6% -155 +1,040 1,670 1,515 +569 +80 -13 -6 1 United States Europe Intl. Chugai Dia Division Group Fx ¹ Group (Japan) CHF Absolute values in C
Slide 44: Q1 2022: Strong underlying business momentum
Q1 2022: Strong underlying business momentum 2022 outlook on COVID-19 related sales (+5bn) and AHR erosion (-2.5bn) confirmed +11% at CER CHFm +449 -568 + 749 -155 + 304 +736 16,445 14,930 Q1 Diagnostics Diagnostics Pharma Ronapreve AHR Fx Q1 base COVID-19 underlying sales erosion1 2021 business sal
Slide 45: Novartis share repurchase: CHF 19bn bridge loan largely refinanced and repaid
Novartis share repurchase: CHF 19bn bridge loan largely refinanced and repaid 19,0 5,5 3,0 CHF bn 4,6 3,3 2,6 Initial bridge USD 6bn CHF 3bn USD 5bn Roche Liquid funds Balance outstanding Loan (Dec 21) (Feb 22) (Mar 22) & CPs (Apr 22) • Roche issued in total USD 11bn and CHF 3bn of bonds since Decem
Slide 46: Exchange rate impact on sales growth
Exchange rate impact on sales growth Slightly negative impact mainly from EUR, JPY and TRY partially offset by USD +0.2p +1.0p -0.7p +0.1p -0.9p -0.1p -0.6p CER CHF sales growth sales growth Q1 2022 Q1 2022 vs. vs. Q1 2021 +11.2% +10.2% Q1 2021 CER EUR APAC USD LATAM JPY Other Other CHF Europe CER=C
Slide 47: 2022 currency impact
2022 currency impact CHF / USD +2% +2% +1% +1% Average YTD 2022 Assuming the 31 March 2022 exchange rates remain 0.92 0.92 0.92 0.92 stable until end of 2022, 0.90 0.91 0.91 0.91 2022 impact1 is expected to be (%p): Average YTD 2021 0.92 0.92 0.93 0.92 0.92 0.92 0.92 0.92 0.92 0.92 0.92 0.92 Q1 HY S
Slide 48: First Roche ESG event focusing on access to healthcare
First Roche ESG event focusing on access to healthcare Our 10-year ambitions to be achieved by 2030 Pharmaceuticals: Double medical advances at less costs to society Roche ESG Event on May 16 Access to Healthcare Diagnostics: Double patient access to novel, high-medical-value diagnostics solutions 1
Slide 49: 2022 outlook
2022 outlook Group sales growth1 • Stable to low-single digit • Low- to mid-single digit (including accretion of Core EPS growth1 4.4%p from share repurchase) Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 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 2022 update New to phase I New to phase II New to phase III New to registration 6 NMEs: 1 NME: 1 NME (EU): RG6344 BRAF inhibitor (3) – solid tumors RG6084 PDL1 LNA – HBV RG6026 glofitamab – 3L+ DLBCL RG6333 CD19xCD28 + glofitamab – r/r NHL RG6163 NME – psychiat
Slide 53: Roche Group development pipeline
Roche Group development pipeline Phase I (49 NMEs + 11 AIs) Phase II (22 NMEs + 13 AIs) RG6007 HLA-A2-WT1 x CD3 AML CHU FIXa x FX haemophilia RG6026 glofitamab + chemo 1L ctDNA high risk DLBCL RG6026 glofitamab monotherapy & combos heme tumors CHU glypican-3 x CD3 solid tumors tiragolumab + T NSCLC
Slide 54: Roche Group development pipeline
Roche Group development pipeline Phase III (10 NMEs + 40 AIs) Registration US & EU (4 NMEs + 9 AIs) Kadcyla + T 2L+ HER-2+ PD-L1+ mBC Venclexta r/r MM t(11:14) RG6013 Hemlibra1 mild to moderate hemophilia A RG3502 RG7601 Kadcyla + T HER-2+ eBC high-risk Venclexta + azacitidine 1L MDS RG6026 glofitam
Slide 55: NME submissions and their additional indications
NME submissions and their additional indications semorinemab Projects in phase II and III RG6100 Alzheimer’s brain shuttle glofitamab + chemo RG6026 RG6102 gantenerumab 2L DLBCL Alzheimer’s glofitamab + chemo New Molecular Entity (NME) Metabolism bepranemab RG6026 1L ctDNA+ high risk RG6416 Addition
Slide 56: AI submissions for existing products
AI submissions for existing products Projects in phase II and III New Molecular Entity (NME) Metabolism Xolair Additional Indication (AI) Neuroscience RG3648 food allergy Oncology / Hematology Ophthalmology Immunology Other Xofluza Infectious Diseases RG6152 direct transmission Xofluza RG6152 influe
Slide 57: Major pending approvals 2022
Major pending approvals 2022 US EU China Japan-Chugai Xofluza Susvimo (PDS) Rozlytrek Tecentriq RG6152 influenza pediatric RG6321 wAMD RG6268 ROS1+ NSCLC RG7446 NSCLC adj Filed March 2020 Filed April 2021 Filed Oct 2021 Filed July 2021 Evrysdi Vabysmo (faricimab) Rozlytrek Hemlibra RG7916 SMA presym
Slide 58: Major granted approvals 2022
Major granted approvals 2022 US EU China Japan-Chugai Vabysmo (faricimab) Tecentriq Actemra RG7716 DME RG7446 NSCLC adj RG1569 COVID-19 pneumonia Jan 2022 March 2022 Jan 2022 Vabysmo (faricimab) Actemra Vabysmo (faricimab) RG7716 wAMD RG1569 RA SC RG7716 DME Jan 2022 April 2022 March 2022 Actemra Va
Slide 59: Doing now what patients need next
Doing now what patients need next