Roche Holding Ltd · SIX:RO
Roche — Q3 2023 Earnings Presentation
51 slides from Roche's earnings presentation, Oct 19, 2023
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 2023 results
Roche YTD September 2023 results Basel, 19 October 2023
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: YTD September 2023 performance; Outlook
YTD September 2023 performance Outlook
Slide 6: YTD Sep 2023: Strong base business growth in both divisions
YTD Sep 2023: Strong base business growth in both divisions Group sales +1% at CER driven by strong base business growth in both divisions • Strong Pharma YTD growth (+9% at CER) driven by Vabysmo, Ocrevus, Hemlibra, Polivy, Evrysdi, Phesgo and Tecentriq • Strong Diagnostics base business YTD growth
Slide 7: YTD Sep 2023: Strong base business growth
YTD Sep 2023: Strong base business growth Young Pharma portfolio and industry leading Diagnostics business driving growth 2023 2022 Change in % Excl. CHFbn CHFbn CHF CER C191 Pharmaceuticals Division 33.6 33.2 1 9 9 Diagnostics Division 10.4 13.8 -25 -18 7 Roche Group 44.1 47.0 -6 1 9 CER=Constant E
Slide 8: Strong Q3 driven by the uptake of new medicines and diagnostics
Strong Q3 driven by the uptake of new medicines and diagnostics Base business more than offsets the decline in COVID-19 products and AHR 15% 14%* 13% 12% 11% 10% 9% 9% 7% 7% 7% 6% 6% 6% 6% 8% 8% 4% 5% 3% 7% 6% 4% 5% 3% 4% 3% 1% 0% 0% 1% 0% -5% -4% -3% -6% -10% AHR1 impact -15% COVID-19 impact Q1 Q2
Slide 9: YTD Sep 2023: Strong base business growth in both divisions
YTD Sep 2023: Strong base business growth in both divisions COVID-19 impact to reduce significantly by end of Q1 2024 Pharma Diagnostics Quarterly sales evolution 2022-2023 Quarterly sales evolution 2022-2023 % CER % CER +30% +30% +24% +20% +20% +11% +8% +9% +9% +7% +8% +7% +10% +7% +10% +4% +6% +4%
Slide 10: Roche played a significant role in fighting the pandemic
Roche played a significant role in fighting the pandemic Q4 2023 and Q1 2024 are the final quarters impacted by the decline in COVID-19 products CHFbn CER 2.0 1.7 1.5 TIB MOLBIOL LightMix® Modular SARS-CoV-2 1.2 ePlex® Respiratory Pathogen Panel 2 cobas® SARS-CoV-2 on the cobas® Liat® cobas® SARS-Co
Slide 11: YTD Sep 2023: Strong base business, sales growth impacted by Fx
YTD Sep 2023: Strong base business, sales growth impacted by Fx Ophthalmology and neuroscience franchises drive portfolio diversification CHFm +1% at CER Diversification of Roche portfolio +665 -856 YTD Sep 2018 YTD Sep 2023 -29 CHF 42.1bn CHF 44.1bn +3,827 -3,152 -3,439 47,037 44,053 Diagnostics Ne
Slide 12: Young portfolio driving Pharma division growth momentum
Young portfolio driving Pharma division growth momentum Keeping historic launch momentum with two NMEs approved in 2023 CHFm % of Pharma Sales** 18,000 50% 16,000 42% 14,000 12,000 34% 10,000 23% 8,000 * 6,000 4,000 2,000 0 YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023 Cotellic Alecensa Tecent
Slide 13: 2023 performance; Outlook
2023 performance Outlook
Slide 14: 2023: Upcoming newsflow
2023: Upcoming newsflow Pharma Diagnostics Tiragolumab + Tecentriq in 1L Columvi + GemOx in 2L+ DLBCL 2024 Modular transportation system, integrated Q1 2024 CCM Vertical PDL1+ NSCLC into existing cobas connection modules Lunsumio + Polivy in 2L+ DLBCL 2024 Tiragolumab + Tecentriq + chemo in Flexible
Slide 15: FY 2023 sales guidance confirmed
FY 2023 sales guidance confirmed Sales drivers1 Pharma: Key products with strong growth and momentum from ongoing launches Diagnostics: Base business with good growth Group sales growth1 Low single digit decline COVID-19 sales for Diagnostics and Pharma expected to decline by roughly CHF -4.5bn AHR2
Slide 16: FY 2023 guidance confirmed
FY 2023 guidance confirmed 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) 16
Slide 17: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 18: YTD Sep 2023: Pharmaceuticals Division sales
YTD Sep 2023: Pharmaceuticals Division sales All regions delivering strong growth, currency headwinds further intensifying in Q3 2023 2022 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 33,622 33,189 1 9 United States 17,680 17,199 3 8 Europe 6,259 6,100 3 7 Japan 2,937 3,029 -3 10 Internati
Slide 19: YTD Sep 2023: Young portfolio delivering strong growth
YTD Sep 2023: Young portfolio delivering strong growth Vabysmo to surpass CHF 2bn in 2023; Polivy with strong launch in 1L DLBCL Vabysmo >500% Ocrevus 14% Hemlibra 19% Polivy 126% Evrysdi 45% Phesgo 66% Tecentriq 11% Perjeta 6% Gazyva 22% Tamiflu 175% Alecensa 9% TNKase / Activase 8% Enspryng 55% Xo
Slide 20: YTD Sep 2023: Oncology portfolio growing +5%
YTD Sep 2023: Oncology portfolio growing +5% YoY CER growth Phesgo (+66%) HER2 franchise HER2 franchise Herceptin Perjeta (+6%) +4% • Kadcyla (+2%): growth in International compensating for US/EU Kadcyla (+2%) • Perjeta (+6%): driven by International Tecentriq +11% • Phesgo (+66%): global conversion
Slide 21: Alecensa: Unprecedented Ph III results in adjuvant ALK+ NSCLC
Alecensa: Unprecedented Ph III results in adjuvant ALK+ NSCLC Risk of disease recurrence or death reduced by 76% Ph III (ALINA) Alecensa in adjuvant ALK+ NSCLC trial design Alectinib Resected 600 mg BID Recurrence Further Stage IB (≥4cm)-IIIA* 2 years treatments at ALK+ NSCLC R Inv. choice 1:1 ECOG
Slide 22: Hematology: Successful rejuvenation leading to rebound
Hematology: Successful rejuvenation leading to rebound Ph III results for Columvi (STARGLO) & Lunsumio (SUNMO) in 2L+ DLBCL expected in 2024 Q3 update • Ph III (SKYLGO) Columvi + Polivy + R-CHP in 1L DLBCL initiated CHFm YoY CER growth Gazyva (+22%) 1,000 -26% • Growth driven by Gazyva combinations
Slide 23: Tecentriq: First PD-(L)1 with subcutaneous formulation
Tecentriq: First PD-(L)1 with subcutaneous formulation Improving convenience for patients, saving resources for healthcare systems CHFm YoY CER growth Q3 update 1,100 • Tecentriq SC: Great Britain approval achieved 1,000 +9% +10% +23% • Ph III (IMbrave152/SKYSCRAPER-14) Tecentriq + tiragolumab + Ava
Slide 24: Hemophilia A: Global SoC with ~40% pts share reached in US/EU5
Hemophilia A: Global SoC with ~40% pts share reached in US/EU5* Expecting continued market share gains for Hemlibra globally CHFm YoY CER growth Q3 update 1,200 • ~22,000 patients treated globally +17% +23% • Continued penetration across all approved patient segments 1,000 • >2/3 of patients on Q4W
Slide 25: Immunology: Overall stable sales
Immunology: Overall stable sales US approval for Xolair autoinjector achieved, option with added convenience CHFm YoY CER growth Q3 update 2,500 Xolair (+3%) +13% • US approval of Xolair autoinjector achieved +1% 2,000 • Growth driven by CSU -25% 0% 1,500 Actemra (+21%) • US/EU: Solid performance in
Slide 26: Multiple Sclerosis: 24% global market share reached
Multiple Sclerosis: 24% global market share reached Positive Ph III (OCARINA II) results of Ocrevus SC Q6M presented at ECTRIMS CHFm YoY CER growth Q3 update 1,750 • Ocrevus with 24% patient share globally (>300k pts treated ) +12% +16% 1,500 • Market leader in US and EU-5 +7% +37% • Higher retentio
Slide 27: Ocrevus: Positive Ph III (OCARINA II) results for SC Q6M dosing
Ocrevus: Positive Ph III (OCARINA II) results for SC Q6M dosing Ocrevus SC Q6M with potential to expand overall CD20 class and gain class share Ph III (OCARINA II) results in RMS/PPMS B-cell depletion over 24 weeks (Ocrevus SC vs IV)a T1 Gd+/- and N/E T2 adjusted lesion ratesb Mean number T1 Gd+/- N
Slide 28: Ocrevus: Strong 10-year results and RWD on family planning
Ocrevus: Strong 10-year results and RWD on family planning Early Tx preserves function in MS; Only CD20 studied for family planning Ocrevus 10-year data in RMS/PPMS RWD with RMS during pregnancy & postpartum2 Ph III (OPERA I/II) Ph III (ORATORIO) in RMS1 in PPMS1 1.25 Annualized relapse rates (95% C
Slide 29: Fenebrutinib: Potential for a best-in-class BTKi in MS
Fenebrutinib: Potential for a best-in-class BTKi in MS Brain penetration and strong efficacy data presented at ECTRIMS Ph II (FENopta) results in RMS Clinical development program Total new T1 Gd+ lesions* CSF concentration Combined (W4, 8 and 12) W4 W8 W12 Fenebrutinib CSF conc. (ng/mL) Fenebrutinib
Slide 30: Spinal muscular atrophy: Evrysdi on track to become global #1
Spinal muscular atrophy: Evrysdi on track to become global #1 Ph II results confirm strong efficacy & safety profile in <2 mos old; EU label expansion achieved CHFm YoY CER growth Q3 update 450 • >11,000 patients treated worldwide; retention rate in first 12 400 +41% months of ~90% globally 350 • US
Slide 31: Ophthalmology: Vabysmo with continued strong momentum
Ophthalmology: Vabysmo with continued strong momentum US/EU filing for third indication in RVO completed Q3 update CHFm YoY CER growth • US market share reaches 19% in nAMD and 12% in DME*; double-digit market share achieved in early launch countries 700 +309% • US: 37% of Vabysmo new patient starts
Slide 32: Zilebesiran: Best-in-disease potential in hypertension
Zilebesiran: Best-in-disease potential in hypertension Positive Ph II (KARDIA-1) results to be presented at AHA Ph I results Ph II (KARDIA-1) topline results Clinical development program Primary endpoint met Ph I Ph II Ph III >90% reduction of serum AGT 24h mean SBP change at month 3 for up to 6 mon
Slide 33: 2023: Key late-stage newsflow
2023: Key late-stage newsflow* Compound Indication Milestone Hemlibra Moderate hemophilia A EU approval Polivy + R-CHP 1L DLBCL US approval Vabysmo RVO US approval/EU filing EU filing Regulatory Tecentriq Subcutaneous administration US approval/EU filing US 2024 / EU filing Columvi (glofitamab) 3L+
Slide 34: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 35: YTD Sep 2023: Diagnostics Division sales
YTD Sep 2023: Diagnostics Division sales Strong base business growth, partially offsetting COVID-19 sales decrease 2023 2022 Change in % Excl. CHFm CHFm CHF CER C191 Diagnostics Division 10,431 13,848 -25 -18 7 Core Lab 5,836 5,833 0 9 Molecular Lab 1,647 2,735 -40 -35 Pathology Lab 1,046 975 7 15 D
Slide 36: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Strong base business growth in Q3 2023 24% 10% 8% 7% 8% 7% 3% 4% 0% -9% -4% -5% -17% Diagnostics Division sales growth Base business sales growth1 -28% Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 Q2 23 Q3 23 1.9bn 1.2bn 0.6bn 0.5bn 0.3bn 0.1bn 0.1bn COVID-19 sales Grow
Slide 37: YTD Sep 2023: Diagnostics Division highlights
YTD Sep 2023: Diagnostics Division highlights Strong base business growth, partially offsetting COVID-19 sales decrease CHFbn YoY CER growth • Immunodiagnostics (+11%) Core Lab +9% • Clinical Chemistry (+10%) • Custom biotech (-11%) • Cervical Cancer (+25%) Molecular Lab -35% • Blood Screening (+14%
Slide 38: YTD Sep 2023: Diagnostics Division regional sales
YTD Sep 2023: Diagnostics Division regional sales Strong base business growth across all regions; significantly lower COVID-19 sales North America -23% EMEA ~28% of divisional sales -17% ~34% of divisional sales Asia Pacific Latin America -19% +6% ~31% of divisional sales ~7% of divisional sales Gro
Slide 39: cobas connection modules (CCM) Vertical
cobas® connection modules (CCM) Vertical Modular and flexible vertical transportation connecting laboratories across floors Fully customizable single-element design • Increase competitiveness: Of the core labs with an to meet customer needs complete automation offering • Optimize laboratory space: C
Slide 40: cobas c 703 and cobas ISE neo analytical units
cobas c 703 and cobas ISE neo analytical units1 Introducing industry leading high-throughput clinical chemistry testing to cobas® pro Increased throughput and New generation analytical units more reagent positions with differentiating innovations Up to 2,000 tests per hour and Self-operating mainten
Slide 41: 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, 2023 and upcoming4 Immuno chemistry assays Clinical chemistry assays EBV EBNA IgG (CE) IGRA SARS-CoV-2 Interferon Gamma Anti-HEV IgG and Fentanyl3 (CE, US)
Slide 42: IL-6 CE claim extension for neonatal sepsis
IL-6 CE claim extension for neonatal sepsis Early diagnosis can prevent ~84% of neonatal deaths1 Neonatal sepsis disease burden1 Addressing unmet need for earlier and improved detection of neonatal sepsis • 3m out of 50m total sepsis cases • Early diagnosis of neonatal sepsis is crucial for timely a
Slide 43: 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 44: Finance
Finance Alan Hippe Chief Financial Officer
Slide 45: YTD Sep 2023: Highlights
YTD Sep 2023: Highlights Sales • Group sales +1% at CER driven by strong base business growth, overcompensating COVID-19 sales decline and AHR biosimilar impact • Strong Pharma YTD growth (+9% at CER) driven by Vabysmo, Ocrevus, Hemlibra, Polivy, Evrysdi, Phesgo and Tecentriq • Strong Diagnostics ba
Slide 46: YTD Sep 2023: Regional sales development
YTD Sep 2023: Regional sales development CER Group sales increase of +1% driven by Pharma Division +8% +7% +12% +10% -18% +1% -6% Pharma Division -18% +9% +303 +397 +799 -2,487 +1,443 455 -3,439 -2,984 1 United States Europe Intl. Chugai Dia Division Group Fx ¹ Group (Japan) CER CHF Absolute values
Slide 47: YTD Sep 2023 exchange rate impact on sales growth
YTD Sep 2023 exchange rate impact on sales growth Negative impact driven by the USD, CNY (APAC), JPY and EUR -0.5%p +1.0% -1.6%p CER CHF -2.4%p sales growth sales growth YTD Sep 2023 YTD Sep 2023 vs. -6.3% vs. YTD Sep 2022 YTD Sep 2022 -0.7%p -1.0%p -0.5%p -0.6%p CER EUR APAC USD LATAM JPY Other Oth
Slide 48: Expected 2023 currency impact
Expected 2023 currency impact CHF / USD Assumed avg. YTD 2023 0% -3% -5% -5% 0.95 0.95 0.94 0.92 Assuming the 30 September 2023 exchange rates 0.90 0.91 remain stable until end of 2023, 0.93 0.91 2023 impact1 is expected to be (%p): 0.92 0.92 0.93 0.90 0.90 0.90 0.87 0.88 0.90 0.92 0.92 0.92 Q1 HY S
Slide 49: 2023 outlook confirmed
2023 outlook confirmed 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) 49
Slide 50: Upcoming Roche IR events
Upcoming Roche IR events Updates on Neuroscience, Digitalization, ASH presentations and Diagnostics Neuroscience Update Digitalization Day ASH Update Diagnostics Day Oct 30 Nov 29 TBA May 22, 2024 Virtual event Virtual event Virtual event London & virtual • Covering ECTRIMS & CTAD data: • Presenting
Slide 51: Doing now what patients need next
Doing now what patients need next