Roche Holding Ltd · SIX:RO
Roche — YTD Sep 2021 Earnings Presentation
53 slides from Roche's earnings presentation, Oct 20, 2021
Slide 1: Roche logo
Slide 2: Roche YTD September 2021 sales
Roche YTD September 2021 sales Basel, 20 October 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 - Severin Schwan, Chief Executive Officer
Group Severin Schwan Chief Executive Officer
Slide 5: YTD Sep 2021 performance; Outlook
YTD Sep 2021 performance Outlook 5
Slide 6: YTD Sep 2021: Continued strong performance; Guidance raised
YTD Sep 2021: Continued strong performance; Guidance raised • Guidance raised: Sales growth to “mid-single digit” from “low- to mid-single digit”, Core EPS growth broadly in line with sales growth • Group sales up +8% – Diagnostics with double digit growth in Q3 (+18%), despite high base, strong rec
Slide 7: YTD Sep 2021: Sales growth driven by Diagnostics Division
YTD Sep 2021: Sales growth driven by Diagnostics Division 2021 2020 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 33.4 34.3 -3 0 Diagnostics Division 13.3 9.7 38 39 Roche Group 46.7 44.0 6 8 CER=Constant Exchange Rates 7
Slide 8: Q3 2021: Strong sales growth
Q3 2021: Strong sales growth 16% 14%* 14% 13% 12% 10% 9% 9% 8% 8% 7% 7% 7% 7% 6% 6% 6% 6% 6% 6% 6% 8% 6% 5% 5% 7% 8% 4% 6% 4% 5% 5% 4% 4% 4% 4% 3% 2% 3% 3% 1% 1% 0% -2% -4% -4% -6% 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 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 13 13 13 13 14
Slide 9: Q3 2021: Strong business momentum
Q3 2021: Strong business momentum % CER 1st wave 2nd wave 3rd wave +60% Pharmaceuticals +50% +55% +48% +50% • Recovery in Q3 2021 expected to continue in Q4 2021 +40% +40% +32% +28% +29% • Impact from biosimilars, expected to flatten in the +30% +25% +18% coming quarters +20% +18% +24% +7% +20% +10%
Slide 10: YTD Sep 2021 Pharma: New products compensating for biosimilar impact
YTD Sep 2021 Pharma: New products with continued momentum compensating for biosimilar impact CHFm % of Pharma Sales CHFm +8% at CER 21,000 +4,018 +3,717 18,000 52% -118 -951 15,000 40% 12,000 29% -3,961 9,000 21% 46,684 43,979 6,000 3,000 0 YTD Sep 2018 YTD Sep 2019 YTD Sep 2020 YTD Sep 2021 YTD 202
Slide 11: YTD Sep 2021 performance; Outlook
YTD Sep 2021 performance Outlook 11
Slide 12: Pharma: Significantly advancing patient care
Pharma: Significantly advancing patient care 39 Breakthrough Therapy Designations received since 2013 Year Molecule Indication 14 new Ph III studies initiated YTD gantenerumab Alzheimer’s disease 2021 Venclexta + azacitidine higher-risk MDS Kadcyla + Tecentriq (KATE 3) in 2L+ HER2+ PDL1+ mBC tiragol
Slide 13: 2021 outlook raised
2021 outlook raised Sales growth to “mid-single digit” from “low- to mid-single digit” Group sales growth1 • Mid-single digit (from 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
Slide 14: Pharmaceuticals Division - Bill Anderson
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 15: YTD Sep 2021: Pharmaceuticals Division sales
YTD Sep 2021: Pharmaceuticals Division sales New products compensating for biosimilars despite COVID-19 impact 2021 2020 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 33,379 34,317 -3 0 United States 16,707 18,389 -9 -5 Europe 6,610 6,268 5 3 Japan 3,186 2,802 14 20 International 6,876 6,85
Slide 16: Continued portfolio rejuvenation: >50% of sales from new products
YTD Sep 2021: Continued portfolio rejuvenation >50% of sales from new products* Ronapreve n/a Hemlibra 42% Actemra / RoActemra 30% Ocrevus 17% Tecentriq 27% Evrysdi >500% Phesgo >500% Kadcyla 16% Alecensa 19% Perjeta 4% Enspryng >500% Polivy 35% Gazyva 8% Xolair 2% Xofluza -120% Esbriet -4% US TNKas
Slide 17: Pharma growth dynamic excl. AHR further improving
Pharma growth dynamic excl. AHR* further improving Quarterly sales development Pharmaceuticals Division (excl. AHR) CHFm 12,000 10,000 Pharma other 8,000 Infectious diseases Ophthalmology 6,000 Immunology Haemophilia A 4,000 Neuroscience Oncology 2,000 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Slide 18: YTD Sep 2021: Oncology still impacted by biosimilars & COVID-19
YTD Sep 2021: Oncology still impacted by biosimilars & COVID-19 YoY CER growth HER2 franchise Phesgo (>500%) • Kadcyla (+16%) with growth in all regions due to adjuvant BC HER2 franchise Herceptin Perjeta (+4%) -6% • Perjeta (+4%) growth cannibalized by Phesgo launch Kadcyla (+16%) Tecentriq Tecentr
Slide 19: Hematology franchise: First positive Ph III (POLARIX) in curative setting
Hematology franchise First positive Ph III (POLARIX) in a curative setting in the last 20 years Ph III (POLARIX) trial design in 1L DLBCL Shaping the standard of care in NHL • Positive Ph III (POLARIX) results for Polivy + R-CHP in 1L DLBCL • Early filings for glofit in 3L+ DLBCL in Q1 2022 and for
Slide 20: HR+/HER2- breast cancer: Giredestrant, a next generation SERD
HR+/HER2- breast cancer: Giredestrant a next generation SERD Encouraging Ph II neoadjuvant interim results presented Selective ER degrader Ph II (coopERA) interim results in Trial program (SERD) neoadjuvant setting Ki67 reduction and complete cell cycle arrest (CCCA) • Potentially best-in-class effi
Slide 21: Tecentriq overview: Growth driven by first-in-class indications
Tecentriq overview: Growth driven by first-in-class indications Landmark results in adj. NSCLC filed globally and US approval achieved CHFm YoY CER growth Tecentriq Q3 update 1,000 +23% 900 +31% Lung franchise (NSCLC, SCLC) +49% +26% 800 +99% +54% +35% • EU: Growth driven by 1L SCLC 700 +136% 600 •
Slide 22: Hemophilia A Franchise: Hemlibra growing strongly
Hemophilia A Franchise: Hemlibra growing strongly 31% US/EU-5 patient share reached CHFm YoY CER growth 900 800 +37% +58% Hemophilia Q3 update 700 +45% +33% • US/EU: Gaining market share in non-inhibitors +57% 600 +146% • #1 prescribed prophylaxis in the US for people with +59% 500 +313% Hemophilia
Slide 23: Immunology franchise remains impacted by COVID-19
Immunology franchise remains impacted by COVID-19 CHFm YoY CER growth Immunology Q3 update 2,500 +13% Actemra (+57%) +5% +7% +1% • WHO recommends IL-6 inhibitors for hospitalized COVID-19 patients 2,000 • Remains leading RA monotherapy in EU-5; shift from IV to SC 1,500 Esbriet (-5%) • COVID-19 impa
Slide 24: MS franchise: Ocrevus total US market share increases to 29%
MS franchise: Ocrevus total US market share increases to 29% MS late stage development programs progressing well CHFm YoY CER growth 1,500 Q3 update +7% • US impacted by SARS-CoV-2 delta wave +37% +16% +31% 1,250 +38% +55% +10% • Higher dose Ocrevus: Ph III (MUSETTE) in RMS and Ph III +48% +12% 1,00
Slide 25: SMA franchise: Evrysdi with strong US and EU launches
SMA franchise: Evrysdi with strong US and EU launches Most prescribed US treatment with ~20% total share after <14 months CHFm YoY CER growth Q3 update 200 • ~4,000 patients treated world wide (commercial, clinical trials, >500% compassionate use) 150 • US: >550 HCPs from >400 sites have prescribed
Slide 26: SMA franchise: Anti-latent myostatin recycling antibody GYM329
SMA franchise: Anti-latent myostatin recycling antibody Ph II/III combination study with Evrysdi initiated Anti-latent myostatin recycling Preclinical GYM329 data in mouse models of muscle disease antibody (GYM329) Efficient inhibition of latent Increase in muscle mass and strength myostatin, but no
Slide 27: Our replace and extend strategy is progressing well
Our replace and extend strategy is progressing well Entering new Replace ongoing franchises franchises Strong news flow ahead (data readout) tiragolumab + Tec (SKY-1) Oncology: in 1L PDL1-high NSCLC Gazyva, Tecentriq (mUC, SCLC, tiragolumab + Tec (SKY-2) Venclexta, HCC, mM, adj. NSCLC), in 1L ES-SCL
Slide 28: 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 29: Diagnostics Division - Thomas Schinecker
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 30: YTD Sep 2021: Diagnostics Division sales
YTD Sep 2021: Diagnostics Division sales Very strong growth driven by COVID-19 and routine testing 2021 2020 Change in % CHFm CHFm CHF CER Diagnostics Division 13,305 9,662 38 39 Core Lab 5,610 4,487 25 26 Molecular Lab 3,454 2,578 34 36 Point of Care 2,058 541 280 279 Diabetes Care 1,294 1,261 3 4
Slide 31: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Maintaining strong routine testing growth 55% 48% Diagnostics Division sales growth 31% 28% Routine sales growth 1 18% 17% 18% 5% 11% 2% 1% -2% -5% Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 -17% COVID-19 Q2: Q3: Q4: Q1: Q2: Q3: Q1: 0.1bn sales 0.6bn 0.6bn
Slide 32: Diagnostics Division regional sales
YTD Sep 2021: Diagnostics Division regional sales Very strong growth in all regions North America +18% EMEA1 ~24% of divisional sales +54% ~43% of divisional sales Asia Pacific Latin America +35% +63% ~27% of divisional sales ~6% of divisional sales Growth rates at CER (Constant exchange Rates); 1 E
Slide 33: Diagnostics Division highlights
YTD Sep 2021: Diagnostics Division highlights Very strong growth across all businesses YoY CER growth Core Lab1 +26% • Immunodiagnostics (+29%) • Clinical Chemistry (+21%) Molecular +36% • Virology (+34%) Lab • POC Molecular (+565%) Point of • POC Immunodiagnostics (+1,469%) +279% Care Diabetes +4%
Slide 34: Elecsys GAAD receives CE mark
Elecsys® GAAD receives CE mark First IVD algorithm for early detection of hepatocellular carcinoma Diagnosis of early stage HCC: AFP vs. GAAD1 HCC N=71, Control N=208 • 830K deaths per year caused by hepatocellular carcinoma2 • Algorithm combines gender and age with the results of two blood-based bi
Slide 35: Claim extension of Elecsys Brahms PCT assay
Claim extension of Elecsys® Brahms PCT assay Monitoring patients on antibiotic therapies improves outcomes and reduces cost of care Higher patient impact More patient benefit Strongly increasing our outreach Better care and treatment for patients on antibiotics NEW 50 420 million1 million2 Diagnosis
Slide 36: Launch of three respiratory test panels on cobas 6800/8800
Launch of three respiratory test panels on cobas 6800/8800 Breaking the barriers of syndromic testing Empowered by TAGS 5 channels = 15 targets • High unmet medical need: TAGS1 differential diagnosis between viruses • Utilizes the cobas® 6800/8800 installed base Channel 1 Channel 2 Channel 3 Channel
Slide 37: Definitive share purchase agreement with TIB Molbiol
Definitive share purchase agreement with TIB Molbiol1 >45 CE IVD & >100 RUO tests available on existing Roche platforms Respiratory Gastroenteritis Carbapenemase Tropical Coronavirus Mutations Mutations Cont. Influenza Resp. Virus Parasites Bacteria Virus KPC Zika* MERS Coronavirus SARS-CoV-2 Spike
Slide 38: Roche Digital Pathology
Roche Digital Pathology Launching new breast panel algorithms and providing a powerful open environment for AI integration for pathologists Expanding portfolio offering • Enables the integration of third party algorithms into the NAVIFY Digital Pathology software1 Launched in 2021 • Provides a broad
Slide 39: 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 40: Finance - Alan Hippe
Finance Alan Hippe Chief Financial Officer
Slide 41: YTD Sep 2021: Highlights
YTD Sep 2021: Highlights Sales • Group sales growth (+8%) driven by Diagnostics (+39%) Currency impact on sales • Negative currency impact due to most currencies, particularly USD Growth rates at CER (Constant exchange Rates) 41
Slide 42: YTD Sep 2021: Group Sales
YTD Sep 2021: Group Sales CER sales up by +8% driven by Diagnostics Division Absolute values in CHFm at Constant Exchange Rates (avg full year 2020); 1 avg. full year 2021 to avg. YTD September 2021 fx impact 42
Slide 43: Currency impact expected to reduce as 2021 progresses
Currency impact expected to reduce as 2021 progresses CHF / USD -7% -6% -5% -4% 0.97 0.97 0.95 Average YTD 2020 0.94 Assuming the 30 Sep 2021 exchange rates remain stable until end of 2021, 0.91 0.91 0.92 0.90 2021 impact 1 is expected to be (%p): Assumed avg. YTD 2021 0.89 0.90 0.93 0.92 0.90 0.91
Slide 44: Upcoming Virtual Event: Digitalization along the value chain
Upcoming Virtual Event Presenters: Digitalization along Alan Hippe, Chief Financial and IT Officer Roche Mark McCarthy, Executive Director Human Genetics, gRED the value chain Christian Gossens, Digital Biomarkers, Global Area Head, pRED Wednesday, 17 November 2021 Jacqueline Law, Vice President, He
Slide 45: 2021 outlook raised
2021 outlook raised Sales growth to “mid-single digit” from “low- to mid-single digit” Group sales growth1 • Mid-single digit (from 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
Slide 46: Changes to the development pipeline
Changes to the development pipeline Q3 2021 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 2 NMEs: 2 AIs: 1 NME: RG6035 brainshuttle (BS)-CD20 - multiple RG6149 astegolimab (Anti-ST2) - chronic RG6171 giredestrant (SERD) – ER+ adj BC RG6413+RG6412 Ronapreve sclero
Slide 47: Roche Group development pipeline
Roche Group development pipeline Phase I (41 NMEs + 12 AIs) Phase II (26 NMEs + 12 AIs) RG6007 HLA-A2-WT1 x CD3 AML CHU FIXa x FX haemophilia tiragolumab + T NSCLC RG6026 glofitamab monotherapy and combos heme tumors CHU glypican-3 x CD3 solid tumors tiragolumab + T + chemo 1L non-squamous NSCLC RG6
Slide 48: Roche Group development pipeline
Roche Group development pipeline Phase III (13 NMEs + 39 AIs) Registration (4 NMEs + 4 AIs) Kadcyla + T 2L+ HER-2+ PD-L1+ mBC Venclexta r/r MM t(11:14) Gavreto (pralsetinib) 1 RET+ NSCLC RG3502 RG7601 RG6396 Kadcyla + T HER-2+ eBC high-risk Venclexta + azacitidine 1L MDS Gavreto (pralsetinib) 2 RET+
Slide 49: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III RG6026 glofitamab + chemo 2L DLBCL RG6180 autogene cevumeran 1L melanoma rhPTX-2 tiragolumab + T semorinemab RG6058 RG6354 (PRM-151) RG6100 1L PD-L1+ cervical ca Alzheimer’s myelofibrosis tiragolumab + T brain shuttle glof
Slide 50: AI submissions for existing products
AI submissions for existing products Projects in phase II and III Xofluza RG6152 direct transmission Xofluza New Molecular Entity (NME) Immunology Neuroscience RG6152 influenza, pediatric Additional Indication (AI) Infectious Diseases Ophthalmology (0-1 year) Oncology / Hematology Metabolism Other X
Slide 51: Major pending approvals 2021
Major pending approvals 2021 US EU China Japan-Chugai PDS with ranibizumab Gavreto (pralsetinib) Tecentriq faricimab RG6321 wAMD RG6396 RET+ NSCLC RG7446 NSCLC adj RG7716 DME Filed April 2021 Filed May 2020 Filed June 2021 Filed June 2021 faricimab Tecentriq faricimab RG7716 DME RG7446 NSCLC adj RG7
Slide 52: Major granted approvals 2021
Major granted approvals 2021 US EU China Japan-Chugai Alecensa (BFAST) Xofluza Xofluza Polivy RG7853 1L NSCLC ALK+ RG6152 influenza, otherwise healthy RG6152 influenza, otherwise healthy RG7596 r/r DLBCL Jan 2021 Jan 2021 April 2021 March 2021 Actemra Xofluza Xofluza Evrysdi RG1569 SSc-ILD RG6152 in
Slide 53: Doing now what patients need next
Doing now what patients need next