Roche Holding Ltd · SIX:RO
Roche — Q1 2021 Earnings Presentation
56 slides from Roche's earnings presentation, Apr 22, 2021
Slide 1: Roche logo
Slide 2: Roche Q1 2021 Sales
Roche Q1 2021 Sales Basel, 21 April 2021
Slide 3: 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 4: Group
Group Severin Schwan Chief Executive Officer
Slide 5: Q1 2021 performance; Outlook
Q1 2021 performance Outlook 5
Slide 6: Responding quickly and broadly to the pandemic
Responding quickly and broadly to the pandemic SARS-CoV-2 Rapid Antigen Nasal Test Casirivimab + imdevimab (nAb cocktail) • Reliably identifies highly infectious individuals in 15 minutes • Emergency use ongoing in US/EU for mild/moderate COVID-19 (Sensitivity: 89.6% at Ct≤30; Specificity 99.1%) at
Slide 7: Q1 2021: Strong Diagnostics Division driving Group sales growth
Q1 2021: Strong Diagnostics Division driving Group sales growth 2021 2020 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 10.6 12.3 -14 -9 Diagnostics Division 4.3 2.9 50 55 Roche Group 14.9 15.1 -1 3 CER=Constant Exchange Rates 7
Slide 8: Q1 2021: Successfully managing the transition in a difficult environment
Q1 2021: Successfully managing the transition in a difficult environment Group sales 6% 8% 7% growth (CER) 4% 3% Group 100% sales 10% 80% 35% 41% 60% 16% 40% 20% 28% 20% 29% 21% 0% Q1 17 Q1 18 Q1 19 Q1 20 Q1 21 1 Diagnostics Division Other pharma AHR New products CER=constant exchange rates; AHR=Ava
Slide 9: Q1 2021: Sales growth despite severe biosimilar impact
Q1 2021: Sales growth despite severe biosimilar impact New products accounting for 50% of Pharma sales Pharma sales mix +3% at CER Q1 2020 CHFm +880 33% 37% +1,538 -376 30% -641 Q1 2021 -1,614 15,143 22% 14,930 50% 28% Q1 2020 Pharma Pharma Pharma Diagnostics Fx Q1 2021 New products launched since 2
Slide 10: Q1 2021: Pandemic continues to impact business dynamics
Q1 2021: Pandemic continues to impact business dynamics % CER 1st wave 2nd wave 3rd wave +60% +50% Pharmaceuticals +50% +55% • Continued severe impact from biosimilars and +40% COVID-19, lack of new patients starts in particular +32% +28% +25% in cancer care +30% +20% +20% +18% +24% +10% +7% Diagnos
Slide 11: Q1 2021 performance; Outlook
Q1 2021 performance Outlook 11
Slide 12: Continuing to invest in innovation
Continuing to invest in innovation Diversifying the late stage pipeline & launching new systems Achievements in Q1 2021: Pharma Achievements in Q1 2021: Diagnostics New to Phase II Serum work area systems launches Brain shuttle gantenerumab in Alzheimer’s disease cobas® pure GABA Aa5 PAM in autism s
Slide 13: 2021 outlook confirmed
2021 outlook confirmed Further growing top and bottom line Group sales growth1 • Low- to mid-single digit Core EPS growth1 • Broadly in line with sales growth Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER); based on the current assessment of the COVID
Slide 14: Pharmaceuticals Division
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 15: Q1 2021: Pharmaceuticals Division sales
Q1 2021: Pharmaceuticals Division sales Sales still impacted by COVID-19 and biosimilars 2021 2020 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 10,600 12,262 -14 -9 United States 5,292 6,616 -20 -14 Europe 2,175 2,264 -4 -6 Japan 852 948 -10 -7 International 2,281 2,434 -6 0 CER=Constant E
Slide 16: Q1 2021: Continued portfolio rejuvenation
Q1 2021: Continued portfolio rejuvenation Ocrevus 16% Hemlibra 33% Tecentriq 26% Casirivimab + Imdevimab n/a Actemra / RoActemra 22% Evrysdi n/a Kadcyla 17% Alecensa 14% Phesgo n/a Perjeta 2% Enspryng n/a Polivy 18% Gazyva -2% Esbriet -8% Lucentis -7% Xofluza -100% US Xolair -6% Tarceva -56% Europe
Slide 17: Pharma growth dynamic excl. AHR slowed down by COVID-19
Pharma growth dynamic excl. AHR* slowed down by COVID-19 Quarterly sales development Pharmaceuticals Division (excl. AHR) CHFm 9,000 8,000 Pharma other 7,000 Infectious diseases 6,000 Ophthalmology 5,000 Immunology Hemophilia A 4,000 Neuroscience 3,000 Oncology 2,000 1,000 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Slide 18: Milestone achieved: 50% of Pharma sales are new products
Milestone achieved: 50% of Pharma sales are new products* Rolling filings for casirivimab/imdevimab and PDS started CHFm % of Pharma Sales 6,000 5,500 50% 5,000 37% 4,500 4,000 3,500 27% 3,000 2,500 19% 2,000 1,500 1,000 500 0 Q1 18 Q1 19 Q1 20 Q1 21 Erivedge Perjeta Kadcyla Gazyva Esbriet Cotellic
Slide 19: Q1 2021: Oncology -19% due to biosimilars & COVID-19
Q1 2021: Oncology -19% due to biosimilars & COVID-19 YoY CER growth HER2 franchise Phesgo • Kadcyla (+17%) with growth in all regions due to adjuvant BC HER2 franchise Herceptin Perjeta (+2%) -11% • Perjeta (+2%) with growth driven by International Kadcyla (+17%) • Successful Phesgo launch in US and
Slide 20: Tecentriq overview: Growth driven by first-in-class indications
Tecentriq overview: Growth driven by first-in-class indications Landmark results in adjuvant NSCLC announced Tecentriq Q1 update CHFm YoY CER growth Lung franchise (NSCLC, SCLC) 900 • US/EU/Japan: Growth driven by 1L SCLC and 1L NSCLC +26% 800 +49% +35% • BTD for tiragolumab + Tecentriq in PDL1+ NSC
Slide 21: Hemophilia A franchise: Hemlibra growing strongly
Hemophilia A franchise: Hemlibra growing strongly 33% total US patient share and 26% total EU-5 patient share reached CHFm YoY CER growth Hemophilia Q1 update 800 • US/EU: Gaining market share in non-inhibitors 700 +33% +45% • >11,000 patients treated globally 600 +57% +146% +59% • #1 prescribed pro
Slide 22: Immunology franchise impacted by COVID-19
Immunology franchise impacted by COVID-19 Immunology Q1 update CHFm YoY CER growth Esbriet (-8%) • COVID-19 impact on new patient starts 2,500 +9% • BTD in unclassifiable interstitial lung disease (uILD) +6% -5% +4% 2,000 Actemra (+22%) • Sales driven by COVID-19; Additional positive study results 1
Slide 23: MS franchise: Ocrevus with 26% total US market share
MS franchise: Ocrevus with 26% total US market share Market leadership maintained CHFm YoY CER growth Q1 update • Ocrevus EU label update to include delay in time to wheelchair 1,500 for PPMS 1,250 +37% +16% +55% +38% +10% • Higher dose Ocrevus: Ph III (MUSETTE) in RMS and Ph III 1,000 +59% +48% +12
Slide 24: SMA franchise: Strong US launch; EU approval achieved
SMA franchise: Strong US launch; EU approval achieved ~1,600 US patients treated (>15% total share) after less than 8 months Broad uptake across all patient types in the US US access enabled by compelling value proposition • ~75% of lives covered due to active payer engagement Patients treated with
Slide 25: SMA franchise: 2-year efficacy update presented at AAN
SMA franchise: 2-year efficacy update presented at AAN Primary and secondary outcomes keep improving Ph III (FIREFISH) 2-year efficacy results in type 1 SMA: Ability to sit without support over 24 months CHOP-INTEND scores over 24 months • Follow up results for Evrysdi in SMA type 1 patients keep im
Slide 26: Ophthalmology franchise: Faricimab positive results in DME & nAMD
Ophthalmology franchise: Benefitting patients globally Faricimab: Positive results in DME & nAMD Ph III (YOSEMITE/RHINE) results in DME BCVA gains at Q8W or up to Q16W Improved anatomic outcomes: Improved durability: non-inferior to aflibercept Q8W Change in CST * >70% on Q12W (with 50% on Q16W) * •
Slide 27: Ophthalmology franchise: PDS approval in the US on track for Q4
Ophthalmology franchise: Benefitting patients globally PDS approval in the US on track for Q4 Phase III (ARCHWAY) 72 week results in nAMD: PDS maintained BCVA through Week 72 ~5x Times fewer treatments in Strong preference for PDS PDS patients amongst patients 3.9 • Ph III (ARCHWAY) data in nAMD sho
Slide 28: Infectious diseases: SARS-CoV-2 development program
Infectious diseases: SARS-CoV-2 development program Positive Ph IIIs for nAb cocktail; First EU shipments in Q1 • Casirivimab+imdevimab: Ph III studies in outpatient setting (Study 2067) and in prevention/prophylaxis setting (Study 2069) positive; Efficacy for high and low dose in the outpatient set
Slide 29: 2021: Key late-stage news flow
2021: Key late-stage news flow* Compound Indication Milestone Xofluza Healthy patients; High risk patients; Post exposure EU approval Evrysdi SMA type 1/2/3 EU approval faricimab DME/nAMD US/EU joint filing (DME+AMD) Regulatory Tecentriq 1L PDL1+ NSCLC EU approval Venclexta + azacitidine 1L unfit AM
Slide 30: Diagnostics Division
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 31: Q1 2021: Diagnostics Division sales
Q1 2021: Diagnostics Division sales Very strong growth driven by COVID-19 and routine testing 2021 2020 Change in % CHFm CHFm CHF CER Diagnostics Division 4,330 2,881 50 55 Core Lab 1,765 1,382 28 31 Molecular Lab 1,107 614 80 86 Point of Care 716 190 277 281 Diabetes Care 460 425 8 13 Pathology Lab
Slide 32: Q1 2021: Diagnostics Division regional sales
Q1 2021: Diagnostics Division regional sales Very strong growth in all regions North America +34% EMEA1 ~24% of divisional sales +62% ~46% of divisional sales Asia Pacific +62% ~24% of divisional sales Latin America +71% ~6% of divisional sales All growth rates at Constant Exchange Rates (CER); 1 Eu
Slide 33: Q1 2021: Diagnostics Division highlights
Q1 2021: Diagnostics Division highlights Very strong growth across all businesses YoY CER growth +31% • Immunodiagnostics (+40%) Core Lab1 • Clinical Chemistry (+13%) • Virology (+198%) Molecular +86% • LightMix Systems (+55%) Lab • POC Molecular (+130%) Point of +281% • POC Immunodiagnostics (+1,53
Slide 34: SARS-CoV-2 diagnostics portfolio
SARS-CoV-2 diagnostics portfolio1 Comprehensive and growing portfolio of tests and digital solutions Clinical Labs Near Patient • cobas® SARS-CoV-2 Launched • cobas® SARS-CoV-2 Variant Launched Molecular • cobas® SARS-CoV-2 & Influenza A/B Launched • cobas® SARS-CoV-2 & Influenza A/B Launched soluti
Slide 35: COVID-19 integrated testing solution
COVID-19 integrated testing solution SARS-CoV-2 Rapid Antigen Nasal Test NAVIFY® Pass Convenient and fast testing experience for patients COVID-19 test results provided directly to individuals • Reliably identifies highly infectious individuals in 15 minutes • Allows patient to receive test results
Slide 36: Launch of cobas SARS-CoV-2 Variant Set test (RUO)
Launch of cobas® SARS-CoV-2 Variant Set test (RUO)1 Support in understanding the prevalence of COVID-19 variants COVID-19 Variants South Africa ● Qualitative detection and differentiation of (501Y-V2)1 SARS-CoV-2 mutations for set of variants: − E484K − N501Y − Deletion HV-69/70 U.K (501Y-V1)1 ● Und
Slide 37: Roche molecular solutions portfolio
Roche molecular solutions portfolio GenMark1 Diagnostics fills the portfolio gap in molecular multiplexing Throughput cobas® Liat® GenMark cobas® 58002 cobas® 6800 cobas® 8800 Molecular Molecular Molecular Molecular high throughput point-of-care multiplexing medium throughput 1 GenMark Diagnostics o
Slide 38: Serum work area systems launches
Serum work area systems launches Enabling comparable results in different size laboratories cobas® pure cobas pro® (high throughput) Optimising efficiency for small size laboratories Increasing scalability and flexibility • Integrates three diagnostic technologies1 on a • Flexibility to add up to 4
Slide 39: FDA BDD for Elecsys GDF-15
FDA BDD for Elecsys GDF-151 Addressing unintentional weight loss in cancer patients • Breakthrough device designation as a companion diagnostic with Pfizer • Detects weight loss (cachexic) patients with solid tumors eligible for investigational drug PF-06946860 • Cachexia is a highly prevalent compl
Slide 40: Improving care for transplant patients
Improving care for transplant patients Launch of Elecsys® EBV tests panel for organ characterization and donor & recipient screening Pre-transplantation Post-transplantation EBV1 serology to determine the infection stage of donor Viral load tests (NAT) are used to monitor high risk and recipients tr
Slide 41: Key launches 2021
Key launches 2021 Area Product Description Market1 cobas® pure integrated solutions Low-to-medium volume SWA CE Core Lab cobas® pro integrated solutions New high throughput configurations of the cobas pro instrument US & CE Point of Care cobas® pulse Successor of Accu-Chek® Inform II CE Instruments
Slide 42: Finance
Finance Alan Hippe Chief Financial Officer
Slide 43: Q1 2021: Highlights
Q1 2021: Highlights Sales • Group sales growth (+3%) driven by Diagnostics (+55%) • Growth dynamic still impacted by COVID-19 M&A • Definitive merger agreement to acquire GenMark Diagnostics for USD 24.05 per share Currency impact on sales • Negative currency impact due to most currencies, particula
Slide 44: Group sales Q1 2021
Group sales Q1 2021 CER sales increase of +3% driven by Diagnostics -14% -6% 0% -7% +3% -1% Pharma Division Dia Division -9% +55% +55% +1,538 +428 -641 -213 -918 -126 -4 -62 PY: +62 11 United States Europe Intl. Chugai Dia Division Group Fx Group (Japan) CHF Absolute values in CHFm at Constant Excha
Slide 45: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact due to most currencies, driven by the USD +0.4p 0.0p CER CHF sales growth +2.9% -3.2p sales growth Q1 2021 Q1 2021 vs. vs. Q1 2020 Q1 2020 -1.4% -0.8p -0.3p -0.2p -0.2p CER EUR APAC USD LATAM JPY Other Other CHF Europe CER=Constant Exchange Rates
Slide 46: Currency impact expected to reduce as 2021 progresses
Currency impact expected to reduce as 2021 progresses CHF / USD -7% -4% -2% -1% 0.97 0.97 Average YTD 2020 0.95 0.94 Assuming the 31 March 2021 exchange rates remain stable until end of 2021, 0.90 0.93 0.93 0.92 Assumed average YTD 2021 2021 impact 1 is expected to be (%p): 0.89 0.90 0.93 0.94 0.94
Slide 47: 2021 outlook confirmed
2021 outlook confirmed Further growing top and bottom line Group sales growth1 • Low- to mid-single digit Core EPS growth1 • Broadly in line with sales growth Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER); based on the current assessment of the COVID
Slide 48: Slide 48
Slide 49: Changes to the development pipeline
Changes to the development pipeline Q1 2021 update New to phase I New to phase II New to phase III New to registration 1 NME: 3 NMEs: 1 NME: RG6433 SHP2i – solid tumors RG6102 Brain shuttle gantenerumab - Alzheimer’s RG6354 rhPTX-2 (PRM-151) - IPF RG6346 HBV siRNA - HBV RG7816 GABA Aa5 PAM – autism
Slide 50: Roche Group development pipeline
Roche Group development pipeline Phase I (45 NMEs + 12 AIs) Phase II (23 NMEs + 13 AIs) RG6007 HLA-A2-WT1 x CD3 AML CHU FIXa x FX haemophilia giredestrant (SERD) neoadjuvant ER+ BC RG6171 RG6026 glofitamab monotherapy and combos heme tumors CHU glypican-3 x CD3 solid tumors giredestrant (SERD) 2/3L
Slide 51: Roche Group development pipeline
Roche Group development pipeline Phase III (15 NMEs + 37 AIs) Registration (3 NMEs + 5 AIs) RG3502 Kadcyla + T 2L+ HER-2+ PD-L1+ mBC RG6268 Rozlytrek ROS1+ 1L NSCLC Gavreto (pralsetinib) 1 RET+ NSCLC RG6396 RG6013 Hemlibra mild to moderate hemophilia A Venclexta r/r MM t(11:14) Gavreto (pralsetinib)
Slide 52: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III glofitamab + chemo RG6026 2L DLBCL rhPTX-2 tiragolumab + T semorinemab RG6058 RG6354 (PRM-151) RG6100 1L PD-L1+ cervical ca Alzheimer’s myelofibrosis tiragolumab + T ipatasertib + fulv + brain shuttle mosunetuzumab glofita
Slide 53: AI submissions for existing products
AI submissions for existing products Projects in phase II and III New Molecular Entity (NME) Immunology Neuroscience Additional Indication (AI) Infectious Diseases Ophthalmology Oncology / Hematology Metabolism Other Xofluza Xofluza RG6152 influenza, pediatric RG6152 direct transmission (1-12 yrs) A
Slide 54: Major pending approvals 2021
Major pending approvals 2021 US EU China Japan-Chugai Esbriet Enspryng (satralizumab) Evrysdi (risdiplam) Evrysdi (risdiplam) RG6062 UILD RG6168 NMOSD RG7916 SMA RG7916 SMA Filed Nov 2020 Filed Aug 2019 Filed March 2020 Filed Oct 2020 Tecentriq Enspryng (satralizumab) RG7446 1L non-sq + sq NSCLC Dx+
Slide 55: Major granted approvals 2021
Major granted approvals 2021 US EU China Japan-Chugai Alecensa (BFAST) Xofluza Polivy RG7853 1L NSCLC ALK+ RG6152 influenza RG7596 r/r DLBCL Jan 2021 Jan 2021 March 2021 Actemra Xofluza RG1569 SSc-ILD RG6152 influenza, high risk March 2021 Jan 2021 Xolair Xofluza RG3648 Self-injection RG6152 post ex
Slide 56: Doing now what patients need next
Doing now what patients need next