Roche Holding Ltd · SIX:RO
Roche — YTD Sep 2022 Earnings Presentation
59 slides from Roche's earnings presentation, Oct 18, 2022
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 YTD September 2022 sales
Roche YTD September 2022 sales Basel, 18 October 2022
Slide 4: Group
Group Severin Schwan Chief Executive Officer
Slide 5: YTD Sep 2022 performance; Outlook
YTD Sep 2022 performance Outlook
Slide 6: YTD Sep 2022: Group sales +2% despite COVID-19 decline in Q3
YTD Sep 2022: Group sales +2% despite COVID-19 decline in Q3 Group sales +2% driven by Diagnostics division • Pharma with stable performance, key products compensating for LOEs and declining COVID-19 sales • Diagnostics with good growth momentum (+6%) including good base business growth (+6%) Key pr
Slide 7: Group sales growth driven by Diagnostics Division
YTD Sep 2022: Group sales growth driven by Diagnostics Division 2022 2021 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 33.2 33.4 -1 0 Diagnostics Division 13.8 13.3 4 6 Roche Group 47.0 46.7 1 2 CER=Constant Exchange Rates; totals may include differences due to rounding 7
Slide 8: Quarterly sales performance: COVID-19 sales coming down
Quarterly sales performance: COVID-19 sales coming down 15% 14%* 13% 12% 11% 10% 9% 9% 7% 7% 7% 6% 6% 6% 6% 6% 8% 8% 5% 4% 7% 6% 5% 5% 4% 4% 1% 3% 3% 3% 1% 0% 0% -5% -4% -6% -10% AHR1 impact -15% 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 Q2 Q3 Q4 Q1 Q
Slide 9: Portfolio rejuvenation ongoing
YTD Sep 2022: Portfolio rejuvenation ongoing CHFm +2% at CER Diversification of Roche business YTD Sep 2017 YTD Sep 2022 -383 CHF 39.4bn CHF 47.0bn + 2’397 -612 +217 -1,460 + 621 -427 AHR AHR 46’684 47’037 Diagnostics Oncology Other pharma AHR Ophthalmology Neuroscience Infectious diseases Hemophili
Slide 10: Solid underlying sales growth in both divisions
YTD Sep 2022: Solid underlying sales growth in both divisions Pharma Diagnostics Quarterly sales evolution 2021-2022 Quarterly sales evolution 2021-2022 % CER % CER +55% +55% +48% +45% +55% +45% +35% +35% +31% +24% +25% +25% +17% +18% +15% +14% +15% +9% +7% +4% +5% +6% +6% +3% +5% +2% +5% +11% +10%
Slide 11: YTD Sep 2022 performance; Outlook
YTD Sep 2022 performance Outlook
Slide 12: Continuous increase in pipeline breadth and depth
Continuous increase in pipeline breadth and depth All-time high for Ph III AIs and industry-leading number of NMEs in the clinic Projects in Ph III & registration Record number of NMEs and AIs (YTD Sep 2022) 18 Phase I Phase II 2 NMEs 8% 2% 3% 10% 14 3 13 13 11% 2 38% 2 1 3% 62 11 3 29 11% 31% 1 4 6
Slide 13: 2022/23: Upcoming Pharma newsflow
2022/23: Upcoming Pharma newsflow 2022 2023 Vabysmo in RVO Tiragolumab + Tecentriq in 1L PDL1+ NSCLC Susvimo in DME Tiragolumab + Tecentriq in 1L Esophageal Susvimo in DR Tecentriq in adjuvant HCC Venclexta in R/R MM (t11;14) Tecentriq in adjuvant SCCHN Gantenerumab in Alzheimer’s disease Tecentriq
Slide 14: R&D focus area Alzheimer's disease
R&D focus area Alzheimer’s disease Clinical results for gantenerumab and blood-based biomarkers to be presented at CTAD Pharmaceuticals gantenerumab • Nearly two decades of scientific investigation with Diagnostics nearly 7000 patient years on treatment • GRADUATE I/II: Patients with early AD (FDA B
Slide 15: 2022 outlook confirmed
2022 outlook confirmed Group sales growth1 • Stable to low-single digit Core EPS growth1 • Low- to mid-single digit Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 15
Slide 16: Pharmaceuticals Division
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 17: Pharmaceuticals Division sales
YTD Sep 2022: Pharmaceuticals Division sales New products compensate for loss-of-exclusivity and COVID-19 sales decline 2022 2021 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 33,189 33,379 -1 0 United States 17,199 16,707 3 -1 Europe 6,100 6,610 -8 -1 Japan 3,029 3,186 -5 7 International 6
Slide 18: Portfolio diversification accelerating
YTD Sep 2022: Portfolio diversification accelerating Ocrevus 17% Hemlibra 28% Evrysdi 101% Phesgo 150% Vabysmo n/a Tecentriq 10% Alecensa 16% Kadcyla 11% Perjeta 5% Xolair 10% Polivy 79% Enspryng 108% Gazyva 8% Tamiflu 56% Gavreto 299% Esbriet -25% US Lucentis -25% Herceptin -18% Europe Ronapreve -3
Slide 19: Oncology portfolio rejuvenation on-going
YTD Sep 2022: Oncology portfolio rejuvenation on-going YoY CER growth Phesgo (+150%) HER2 franchise HER2 franchise Herceptin Perjeta (+5%) +4% • Kadcyla (+11%) with growth ex-US due to adjuvant BC Tecentriq +10% Kadcyla (+11%) • Perjeta (+5%) driven by International, especially APAC Hematology Poliv
Slide 20: HER2+ franchise: Continued growth
HER2+ franchise: Continued growth Multiple Ph III combination trials initiated Phesgo’s strong global launch continues Kadcyla growth driven by adjuvant setting Global Phesgo conversion rate* 50% Neoadjuvant Adjuvant cont. PCR (55%) 40% 50% Surgery 30% 30% 20% Residual Disease (45%) 10% HER2+ Adjuva
Slide 21: Giredestrant: Early data support continued development in ER+ BC
Giredestrant: Early data support continued development in ER+ BC Ph III (persevERA) interim results in 1L ER+ BC expected for 2024 Ph II (acelERA) results in 2/3L ER+/HER- BC Ph II (coopERA) results in neoadjuvant ER+/HER- BC PFS-INV: ESR1m subgroup • PFS benefit was more pronounced in patients with
Slide 22: Tecentriq overview: Adjuvant key trials now to read out in 2023
Tecentriq overview: Adjuvant key trials now to read out in 2023 First PD-(L)1 with pivotal SC results to be filed in 2022 CHFm YoY CER growth Tecentriq Q3 update 1,000 +9% • Positive Ph III (IMscin001) results for SC administration 900 +23% Lung franchise (NSCLC, SCLC) 800 +49% 700 • EU: Strong laun
Slide 23: Hemophilia A franchise: Hemlibra new global standard of care
Hemophilia A franchise: Hemlibra new global standard of care 36% US/EU-5 patient share reached CHFm YoY CER growth Hemophilia Q3 update 1,200 • >18,000 patients treated globally +23% 1,000 • Hemlibra continues to penetrate across all approved patient segments +37% 800 • 2nd generation FIXa x FX bi-s
Slide 24: Immunology franchise
Immunology franchise Actemra COVID-19 sales declining and Esbriet generic competition CHFm YoY CER growth Immunology Q3 updates 2,500 Actemra (-42%) +13% +5% • COVID-19 demand completely washed out in Q3 +1% 2,000 -25% • Submitted to EMA for approval in SSC-ILD 1,500 • Shift from IV to SC ongoing Xo
Slide 25: MS franchise: Ocrevus #1 treatment in US and EU-5
MS franchise: Ocrevus #1 treatment in US and now also in EU-5 MS development programs well on track CHFm YoY CER growth Q3 update 1,750 • >250.000 patients treated globally +16% 1,500 • #1 treatment in US and EU-5, both in total share and new to +37% +7% brand share 1,250 • Higher persistence than o
Slide 26: MS franchise: Subcutaneous dosing and higher dose Ocrevus
MS franchise: Subcutaneous dosing and higher dose Ocrevus Q6M SC dosing readout expected in 2023 Ocrevus SC will retain Q6M dosing Ocrevus higher dose vs 600 mg in RMS and PPMS Administration and observation schedule Total time Double-blind treatment (min. of ≥120 weeks) Ocrevus higher dose 1,200/1,
Slide 27: SMA franchise: Evrysdi with strong global momentum
SMA franchise: Evrysdi with strong global momentum Well-positioned to become #1 worldwide Q3 update CHFm YoY CER growth • >7,000 patients treated worldwide (commercial, clinical 350 trials, compassionate use) +93% 300 • Retention rate in first 12 months of ~90% globally 250 • US: Growth driven by sw
Slide 28: Ophthalmology franchise: Excellent Vabysmo launch
Ophthalmology franchise: Excellent Vabysmo launch More than 165k vials shipped in the US in the first 7 months Q3 update CHFm Vabysmo 200 • US: Strong uptake with switches primarily from aflibercept and first naïve patient starts 150 • US: Permanent J-code granted on October 1st 100 • EU: Approval g
Slide 29: Vabysmo: Improved overall disease control in DME
Vabysmo: Improved overall disease control in DME Treat & extend study design well-aligned with clinical practice Ph III trial design in DME (YOSEMITE/RHINE) Ph III (YOSEMITE/RHINE) 2 year results 14 YOSEMITE/RHINE Pooled From Baseline, ETDRS Adjusted Mean BCVA 12 10 Change Letters 8 Average of weeks
Slide 30: Vabysmo: 2 year nAMD data presented at ASRS
Vabysmo: 2 year nAMD data presented at ASRS Strong BCVA and CST results sustained over 2 years Ph III trial design in nAMD (TENAYA/LUCERNE) Ph III (TENAYA/LUCERNE) 2 year results Primary Endpointa Change in BCVA from Disease Activity baseline averaged over the week 40, 44, and 48 visits Assessment F
Slide 31: Vabysmo: Disease criteria chosen impact patient allocation
Vabysmo: Disease criteria chosen impact patient allocation Vabysmo nAMD trials use disease criteria reflective of clinical practice1 Different ≥Q12W disease criteria as applied to TENAYA/LUCERNE patients Stringent criteria** Share of patients on ≥Q12W dosing Treatment change if ANY criteria are met
Slide 32: 2022: Key late-stage news flow and upcoming IR events
2022: Key late-stage news flow* and upcoming IR events Compound Indication Milestone Vabysmo nAMD/DME US/EU approval Susvimo nAMD EU approval Delayed Lunsumio (mosunetuzumab) 3L+ FL US/EU approval EU Regulatory Tecentriq Adjuvant NSCLC EU approval Hemlibra Mild to moderate hemophilia A EU approval P
Slide 33: Diagnostics Division
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 34: Diagnostics Division sales
YTD Sep 2022: Diagnostics Division sales Sales increase of +6% driven by base business and COVID-19 testing 2022 2021 Change in % CHFm CHFm CHF CER Diagnostics Division 13,848 13,305 4 6 Core Lab1 5,833 5,677 3 5 Point of Care1 3,086 2,415 28 30 Molecular Lab1 2,735 3,030 -10 -8 Diabetes Care 1,219
Slide 35: Diagnostics Division highlights
YTD Sep 2022: Diagnostics Division highlights Growing from a high base in 2021 CHFbn YoY CER growth • Immunodiagnostics (+6%) Core Lab1,3 +5% • Clinical Chemistry (+8%) • Custom biotech (-8%)3 • POC Immunodiagnostics (+39%) Point of Care3 +30% • POC Molecular3 (+33%) • qPCR&NAP (-28%) Molecular Lab3
Slide 36: Diagnostics Division regional sales
YTD Sep 2022: Diagnostics Division regional sales Strong base business growth across all regions North America +20% EMEA1 ~28% of divisional sales -13% ~33% of divisional sales Asia Pacific Latin America +28% -3% ~33% of divisional sales ~6% of divisional sales Growth rates at CER (Constant exchange
Slide 37: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Strong base business growth 55% Diagnostics Division sales growth 48% Base business sales growth 1 28% 31% 24% 18% 17% 18% 9% 10% 7% 5% 2% 11% 3% 1% -2% 8% -5% -4% 0% Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 Q3 22 -17% 0.1bn 0.6bn 0.6bn
Slide 38: Our contribution against COVID-19
Our contribution against COVID-19 Roche has enabled access to >1.8 billion tests to fight the COVID-19 pandemic 20+ solutions >1.8 billion COVID-19 Responsible pricing to ~2’000 cobas® 6800/8800 tests enable access instruments placed1 Broad portfolio of COVID-19 Conducted with our products Costs sho
Slide 39: Roche Digital LightCycler
Roche Digital LightCycler® Filling the gap between standard PCR and sequencing • Digital PCR system with IVD label & superior performance • Key differentiators: – Powerful analytical software & simpler workflow - no more emulsions Analyzer Partition engine – Flexibility to tailor assays from high se
Slide 40: PRAME immunohistochemistry assay
PRAME immunohistochemistry assay Enabling optimal patient prognosis via early & accurate diagnosis and treatment of melanoma 5 year survival rates • >300k new cases and ~60k death per year caused by Melanoma cancer3 99% Localized • Key immunohistochemistry assay to: Melanoma survival Help differen
Slide 41: Elecsys Amyloid Plasma Panel clinical results
Elecsys® Amyloid Plasma Panel clinical results Addressing the unmet need of early detection of Alzheimer’s disease pathology 1 2 3 Triage Confirmation Therapy Patients undergoing initial evaluation Patients referred for amyloid Patients identified for future for non-specific cognitive decline1 confi
Slide 42: Key launches 2022
Key launches 2022 Area Product Description Market Status Automated immunohistochemistry/in situ hybridization (ISH) advanced staining platform with Pathology Lab BenchMark ULTRA PLUS US & CE enhanced software capabilities, workflow and testing efficiency DP600 High capacity pathology slide scanner f
Slide 43: Finance
Finance Alan Hippe Chief Financial Officer
Slide 44: YTD Sep 2022: Highlights
YTD Sep 2022: Highlights Sales • Group sales growth of +2% • Solid Pharma and Diagnostics underlying growth Currency impact on sales • Negative currency impact especially in Q3, particularly weaker EUR and JPY, only partially offset by stronger USD Growth rates at CER (Constant exchange Rates) 44
Slide 45: Portfolio rejuvenation ongoing
YTD Sep 2022: Portfolio rejuvenation ongoing CHFm +2% at CER Diversification of Roche business YTD Sep 2017 YTD Sep 2022 -383 CHF 39.4bn CHF 47.0bn + 2’397 -612 +217 -1,460 + 621 -427 AHR AHR 46’684 47’037 Diagnostics Oncology Other pharma AHR Ophthalmology Neuroscience Infectious diseases Hemophili
Slide 46: Regional sales development
YTD Sep 2022: Regional sales development -1% -1% 0% +7% +6% +2% +1% Pharma Division +6% 0% -427 +838 780 353 -239 +236 +18 -73 1 United States Europe Intl. Chugai Dia Division Group Fx ¹ Group (Japan) CER CHF Absolute values in CHFm at Constant Exchange Rates (avg full year 2021); 1 avg. full year 2
Slide 47: YTD exchange rate swings
YTD exchange rate swings Negative impact driven by the EUR, JPY and other Europe, partially offset by USD -0.1p -1.0p CER CHF sales growth sales growth +1.9p +0.1p YTD Sep 2022 YTD Sep 2022 vs. vs. YTD Sep 2021 -1.2p -0.7p YTD Sep 2021 +1.7% +0.1p +0.8% CER EUR APAC USD LATAM JPY Other Other CHF Eur
Slide 48: Expected currency impact 2022
Expected currency impact 2022 CHF / USD Average YTD 2022 +2% +4% +4% +5% 0.94 0.95 0.96 Assuming the 30 September 2022 exchange rates 0.92 remain 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 0.94 0.98 0.97 0.97 0.96 0.97 0.98 0.98
Slide 49: 2022 outlook
2022 outlook Group sales growth1 • Stable to low-single digit Core EPS growth1 • Low- to mid-single digit 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: Appendix contents
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 Q3 2022 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 1 NME: 4 AIs: 1 NME (First filed in China*): RG6536 vixarelimab – immunology RG7314 balovaptan – post-traumatic stress RG6168 Enspryng – MOG-AD RG6017 crovalimab - PNH RG653
Slide 53: Roche Group development pipeline
Roche Group development pipeline Phase I (51 NMEs + 11 AIs) Phase II (21 NMEs + 8 AIs) RG6007 HLA-A2-WT1 x CD3 AML RG7827 FAP-4-1BBL monotherapy + combos solid tumors RG6026 glofitamab + chemo 1L ctDNA high risk DLBCL RG6026 glofitamab monotherapy + combos heme tumors Lunsumio (mosunetuzumab) tirago
Slide 54: Roche Group development pipeline
Roche Group development pipeline Phase III (10 NMEs + 46 AIs) Registration US & EU (3 NMEs + 7AIs) Kadcyla + T 2L+ HER-2+ PD-L1+ mBC RG3648 Xolair food allergy RG6013 Hemlibra1 mild to moderate hemophilia A RG3502 Kadcyla + T HER-2+ eBC high-risk RG6354 zinpentraxin alfa (PRM-151 ) IPF RG6026 glofit
Slide 55: NME submissions and their additional indications
NME submissions and their additional indications Projects in phase II and III glofitamab + chemo autogene cevumeran bepranemab RG6026 1L ctDNA+ high risk RG6180 RG6416 1L melanoma Alzheimer's New Molecular Entity (NME) Metabolism DLBCL Additional Indication (AI) Neuroscience tiragolumab + T zinpentr
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 Phesgo OBI RG6264 Infectious Diseases HER2+ BC Gavreto Kadcyla + Tecentriq RG6396 RG3502 Tumor agnostic
Slide 57: Major pending approvals 2022
Major pending approvals 2022 US EU China Japan-Chugai Lunsumio (mosunetuzumab) Susvimo (PDS) Polivy Gazyva RG7828 3L+ FL RG6321 wAMD RG7596 1L DLBCL RG7159 1L CLL Filed Dec 2021 Filed April 2021 Filed Nov 2021 Filed March 2022 Actemra Hemlibra Polivy Phesgo RG1569 COVID-19 pneumonia RG6013 mild to m
Slide 58: Major granted approvals 2022
Major granted approvals 2022 US EU China Japan-Chugai Vabysmo (faricimab) Polivy Tecentriq Actemra RG7716 DME RG7596 1L DLBCL RG7446 NSCLC adj RG1569 COVID-19 pneumonia Jan 2022 May 2022 March 2022 Jan 2022 Vabysmo (faricimab) Tecentriq Actemra Vabysmo (faricimab) RG7716 wAMD RG7446 NSCLC adj RG1569
Slide 59: Doing now what patients need next
Doing now what patients need next