Q3 2022 Results

Made public by

sourced by PitchSend

33 of 102

Creator

Novartis logo
Novartis

Category

Healthcare

Published

Q3 2022

Slides

Transcriptions

#1Company overview Financial review 2022 priorities Appendix References Q3 2022 Results Investor presentation U NOVARTIS | Reimagining Medicine#2Company overview Financial review 2022 priorities Appendix References Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as "potential," "expected," "will," "planned," "pipeline," "outlook," or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding potential future, pending or announced transactions; or regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the conclusion of the strategic review of Sandoz, our intention to separate Sandoz by way of a 100% spin-off, through which we plan to become a fully focused Innovative Medicines business; or our efforts to petition the US Supreme Court to uphold the validity of the Gilenya US dosing regimen patent; or regarding the Group's liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. In particular, our expectations could be affected by, among other things: the potential that we may not be able to complete the planned 100% spin-off of Sandoz within the expected time frame, in the planned form, or at all; the potential that the benefits and opportunities expected from our planned 100% spin-off of Sandoz may not be realized or may be more difficult or take longer to realize than expected; liquidity or cash flow disruptions affecting our ability to meet our ongoing financial obligations and to support our ongoing business activities; the impact of a partial or complete failure of the return to normal global healthcare systems, including prescription dynamics; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in this presentation; the uncertainties in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; safety, quality, data integrity, or manufacturing issues; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, investigations or disputes; our performance on environmental, social and governance measures; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. Ibrance® is a registered trademark of Pfizer Inc. Verzenio® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates. 2 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#3Company overview Financial review 2022 priorities Appendix References Vas Narasimhan Chief Executive Officer Company overview 3 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#4Company overview Financial review 2022 priorities Appendix References Novartis delivers solid Q3 performance across our value drivers Growth, cc Group sales Q3 +4% (YTD +5%) IM sales Q3 +4% (YTD +5%); US IM sales Q3 +8% Sandoz sales Q3 +4% (YTD +6%) 1 Innovation Productivity, cc Group core operating income Q3 +5% (YTD +6%) IM core operating income Q3 +7% (YTD +6%) IM core margin Q3 38.1%, +1.0%pts (YTD 37.1%) Sandoz core operating income Q3 -5% (YTD +5%) SG&A savings of ~USD 1.5bn to be fully embedded by 20242 3 Scemblix approved in EU for Ph+ chronic myeloid leukemia Pluvicto CHMP positive opinion for mCRPC post-taxane³ Iptacopan Ph3 PNH, clinically meaningful superiority vs anti-C53 Cosentyx positive Ph3 SUNSHINE/SUNRISE in Hidradenitis Suppurativa 2 ESG 4 Ganaplacide/lumefantrine Malaria¹ US FDA Orphan Drug and Fast Track Designation Pediatric formulation of Hydroxyurea SCD launched in Ghana Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 49 of Condensed Interim Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. IM - Innovative Medicines Division SCD Sickle cell disease 1. Combination, being co-developed with Medicines for Malaria Venture, supported by EDCTP WANECAM2, for acute, uncomplicated malaria 2. Relating to streamlined organizational model. 3. Oct 2022 4 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#5Company overview Financial review 2022 priorities Appendix References Strong performance of EntrestoⓇ, KesimptaⓇ, Kisqali ®, PluvictoⓇ Q3 sales1 Sales Growth vs. PY USD million USD million Entresto sacubitril/valsartan 1,135 Kesimpta 289 (ofatumumab) KISQALI 327 95 ribociclib 80 80 PLUVICTO™ Ⓒ SCEMBLIX* 41 41 (asciminib) Tafinlar. Mekinist. 450 33 decent LEQVIO® 34 29 Cosentyx 1,274 27 (secukinumab) PIQRAY (alpelisib) tablets MAYZENT. 103 21 94 18 (siponimod) tablets LUTATHERA 132 12 Growth vs. PY CC 211 31% 180 172% 49% nm nm 16% nm 7% 26% 29% 15% Constant currencies (cc) is a non-IFRS measure; explanation of non-IFRS measures can be found on page 49 of Condensed Interim Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. nm not meaningful 1. Innovative Medicines division. 5 Investor Relations | Q3 2022 Results 1 GROWTH ✓ NOVARTIS | Reimagining Medicine#6Company overview Financial review 2022 priorities Appendix References 1 GROWTH Six in-market growth drivers with multi-bn sales potential and recent launches reinforce our confidence in mid-term growth outlook 6 in-market growth drivers, multi-bn potential Cosentyx® Entresto® zolgensma 33% of IM sales growing 23% (Q3) KISQALIⓇ Kesimpta LEQVIO® Recent launches • SCEMBLIX® All growth rates in constant currencies (cc). 6 Investor Relations | Q3 2022 Results PLUVICTO™ Scemblix and Pluvicto off to a good start NOVARTIS | Reimagining Medicine#7Company overview Financial review 2022 priorities Appendix References CosentyxⓇ showed steady growth, preparing for LCM Sales evolution USD m, % cc Ex-US US +7% cc 1 GROWTH Cosentyx E AZ K K L Maintaining competitive position across geographies " >875k patients treated across 5 indications since launch 1,247 1,274 494 532 ■ US: Solid volume growth, offset by revenue deductions Europe: Leading originator biologic in PsO and SpA Future growth drivers ☐ Volume-driven growth across core indications Expanding geographical reach including China Hidradenitis Suppurativa regulatory file submitted to FDA and EMA IV regulatory file expected to be submitted in Q4 to FDA 753 742 ☐ ☐ Additional life cycle management including giant cell arteritis Q3 2021 Q3 2022 PSO Psoriasis SpA Spondyloarthritis IV-intravenous 7 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#8Company overview Financial review 2022 priorities Appendix References Entresto® +31% cc, growing strongly across geographies Sales evolution USD m, % cc US weekly TRX¹ Total prescriptions (000) Ex-US US 100 90 +31% 80 1,135 70 924 60 565 50 519 40 30 20 570 405 10 0 Q3 2021 Q3 2022 10/07/2015 прициу 23/09/2022 1 GROWTH C Entresto AZ K &K L Strong quarter performance ■ WW: Increased to >8m patients on treatment? ■ US: Accelerated momentum, ~1.1m TRx in Q3 Europe: Strong demand growth continues Future growth drivers ☐ Only 1/3 of eligible HFrEF population on treatment in G72 Strong profile in clinical and RW settings in HF3,4 Guidelines (AHA/ACC/HFSA) support Entresto as 1st choice in HFrEF, expand support in HFPEF5,6 Hypertension: High unmet need in Asia Pacific See last page for references TRX Total Prescriptions WW-Worldwide HFrEF - heart failure with reduced ejection fraction HFSA Heart Failure Society of America HFPEF-heart failure with preserved ejection fraction RW - Real world AHA-American Heart Association ACC American College of Cardiology 8 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#9Company overview Financial review 2022 priorities Appendix References ZolgensmaⓇ sales now predominantly incident patient population C Ezolgensma K KL Sales evolution USD m Ex-US Both US and ex-US market now mainly incident patient population US 375 379 363 342 319 315 ◉ YTD double digit growth in incident patients treated 319 ◉ 2500+ patients treated worldwide¹ 254 249 256 224 250 200 209 220 ◉ 148 106 119 126 106 118 113 123 99 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2020 2021 2022 1. Across clinical trials, managed access programs and in the commercial setting. 9 Investor Relations | Q3 2022 Results 3 Q3 Future growth drivers ☐ ☐ Foundational treatment for SMA type 1 newborns Now approved in 45 countries with access pathways in place in 30+ - Access negotiations ongoing in 10+ countries (e.g. Brazil, Argentina) Efforts ongoing to increase newborn screening (35% in Europe; 98% in US) IT data: STEER enrolling continues; STRENGTH to start in Q4 2022 NOVARTIS | Reimagining Medicine#10Company overview Financial review 2022 priorities Appendix References KisqaliⓇ grows strongly across all regions Increasing recognition of overall survival and quality of life benefits Sales evolution USD m, % CC Ex-US US +49% 7 327 232 193 145 mBC monthly % NBRx share 63 Ibrance® -KisqaliⓇ 1 GROWTH YCE AZ KISQALI KL -VerzenioⓇ 58 56 57 40 53 49 19 33 33 31 31 54 44 33 55 59 557 51 44 43 40 35 33 27 27 28 28 31 31 31 34 26 26 20 18 18 14 15 13 12 13 14 10 134 87 Q3 2021 Q3 2022 Sep Oct Nov Dec Jan Feb Mar Apr May Jun 2021 Jul Aug 2022 mBC Metastatic breast cancer NBRX - New to Brand prescriptions CDK Cyclin Dependent Kinase 1. Of CDK4/6 mBC market, monthly 10 Investor Relations | Q3 2022 Results Sales accelerating: US NBRx share 26% (vs. 10% PY)1 Driven by Kisqali's unique profile: - Only CDK4/6 with overall survival benefit across 3 Ph3 studies - Improved / maintained quality of life in MBC First head-to-head CDK4/6 study (vs. IbranceⓇ HARMONIA): recruitment ongoing; final analysis expected 2026 NATALEE adjuvant study primary analysis expected H2 2023 NOVARTIS | Reimagining Medicine#11Company overview Financial review 2022 priorities Appendix References 1 GROWTH KesimptaⓇ strong sales growth mainly driven by US launch momentum YCE Z K Kesimpta L Sales evolution USD m, % cc Ex-US US +172% Launch acceleration continues¹ 7 289 239 195 147 109 66 TRX +131% NBRX +47% vs. market -20% B-cell NBRx share -30% ■ Adding ~100 new writers/month Fast initiation within 5 days for 80% patients² >27k patients treated WW Benefit/risk profile (new data) 50 ☐ New 4-year data in recently diagnosed and treatment naive Kesimpta treated patients (subgroup) support use in early stages of RMS disease³ Q1/21 Q2/21 Q3/21 Q4/21 Q1/22 Q2/22 Q3/22 WW-worldwide TRX - Total Prescriptions NBRX - New to brand Prescription DMT Disease Modifying Therapy 1. Refers to US unless otherwise stated 2. Time to bridge. Data on file 3. Data from ALITHIOS study. Analysis compares continuous treatment with Kesimpta and later switch from teriflunomide in recently diagnosed treatment naive patients (subgroup). Gartner J et al. Longer-term Safety and Efficacy of Ofatumumab in Recently Diagnosed and Treatment Naïve Patients is Consistent with the Overall Population in the ALITHIOS Open-Label Extension Study. Poster presented at ECTRIMS 2022. P052. 11 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#12Company overview Financial review 2022 priorities Appendix References Leqvio® US launch - steadily building the foundation Expect continued steady ramp through H1 2023 Driving broad HCP adoption HCPs initiating a patient¹ on LeqvioⓇ -800 ~2400 ~4800 ■ Q3 sales USD 34m YCE AZ N 1 GROWTH K &K LEQVIO® ■ HCP adoption doubled vs. Q2, focus on breadth + depth ■ Broad access: 70% coverage at-or-near label ■ Favorable affordability: 2/3 of patients with zero co-pay ■ Free Trial Offer launched to support patient initiation² Working through practice logistics and administration ■ AHA: 4-year efficacy and safety data to be presented (ORION-3) Q1 2022 Q2 2022 Q3 2022 HCP Healthcare Professional AHA - American Heart Association 1. Either prescribe LeqvioⓇ to a patient based on service center data, data on file or have ordered through Free Trial Offer program. 2. Free Trial Offer program allows HCP to order one free dose per lifetime per patient. *Leqvio® is administered initially, again at 3 months, and then once every 6 months. 12 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#13Company overview Financial review 2022 priorities Appendix References Pluvicto™ continues strong start in the US 1 GROWTH PLUVICTO™ Rapid launch uptake in US Q3 sales of USD 80m; NBRx share 14% in post-taxane mCRPC Over 120 centers actively ordering; focus in Q3 on smooth supply and customer service More than 75% of insured lives covered (across Medicare, Medicaid and private payers) Permanent A code effective in October Preparing for further expansion ✓ Steadily expanding treatment centers in the US ✓ Significantly increasing manufacturing capacity (Ivrea in 2022; Millburn and Indianapolis planned in 2023) Positive CHMP opinion²; expected EU rollout 2023 ✓ Earlier line studies on track: ■ PSMAfore (pre-taxane) readout expected YE 20221 ■ PSMAddition (mHSPC) readout expected 2024 CHMP Committee for Human Medicinal Products NBRX - New to Brand prescriptions mCRPC metastatic castration-resistant prostate cancer 13 Investor Relations | Q3 2022 Results 1. Event-driven, could move to early 2023. 2. Oct 2022. ✓ NOVARTIS | Reimagining Medicine#14Company overview Financial review 2022 priorities Appendix References ScemblixⓇ continues strong launch momentum in Q3 1 GROWTH • SCEMBLIX® Strong early launch uptake ☑ $41m Q3 sales driven by patients with resistance/intolerance to other TKIs Future growth drivers US Accelerated approval converted to regular approval based on 96wk data ✓ 13% 3L+ total patient share¹, 2x ponatinib in 8 months. Global Rollout ongoing with EU approval in Q3; strong early uptake in JP and UK ✓ 39% 3L+ new patient share1 1L Ph3 study enrolling ahead of plan, readout expected H2 2024 TKI Tyrosine Kinase Inhibitor 1. IQVIA Market Sizing "Source of Business" and "Product Summary" reports as of September 2022. 14 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#15Company overview Financial review 2022 priorities Appendix References 3 INNOVATION Cosentyx® - rapid and sustained efficacy in Hidradenitis Suppurativa up to 52 weeks High unmet need -1 in 100 ~95% ~50% Cosentyx® Ph3 data (SUNSHINE, SUNRISE)4 Week 16 Cosentyx Week 52 ☐ Rapid relief from pain, flares, lesions, Low Dose High Dose while improving quality of life Low Dose 1:1 High Dose Sustained up to 52 weeks5 people affected by HS1 eligible patients not on biologic² biologic-treated patients lose response³ moderate to severe hidradenitis suppurativa Secukinumab Low Dose Secukinumab High Dose 1:1:1 Placebo The primary endpoint is the HiSCR at Week 16 HiSCR response: At least a 50% decrease in abscess and Inflammatory Nodule count with no increase in the number of abscesses and/or draining tunnels response Favorable reinforced safety across 5 systemic conditions HS Hidradenitis Suppurativa HiSCR - Hidradenitis Suppurativa Clinical Response 1. MedLine Plus. Hidradenitis suppurativa [online] [Last accessed: Oct 2022]. 2. G6 market estimations based on IQVIA PADDS 2021. 3. Kimball A, et al. N Engl J Med. 2016;375:422-434. 4. Kimball A, et al. LB-3549 presented at EADV Congress 2022. 5. Topline results based on interim analysis where 95% of Ph3 study patients completed or discontinued by Week 52. 15 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#16Company overview Financial review 2022 priorities Appendix References PNH first pivotal read-out for iptacopan "pipeline in a pill" with combined multi-blockbuster potential Indication 2021 2022 2023 2024 2025 2026 PNH IgAN * C3G aHUS IC-MPGN Phase 3 studies initiated or planned 9 months readout may support US submission for accelerated approval Multi-blockbuster potential across indications 3 INNOVATION Paroxysmal nocturnal hemoglobinuria (PNH) Phase 3 trials APPLY-PNH both primary endpoints of superiority vs. anti-C5 antibody met APPOINT-PNH in patients naive to anti-C5 antibody therapy expected to read out in 2022 IgAN - IgA nephropathy C3G C3 glomerulopathy IC-MPGN - Immune Complex Membranoproliferative glomerulonephritis aHUS atypical hemolytic uremic syndrome PNH - paroxysmal nocturnal hemoglobinuria 16 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#17Company overview Financial review 2022 priorities Appendix References 3 INNOVATION APPLY-PNH demonstrated clinically meaningful superiority vs. anti-C5 Anti-C5 antibody Up to 8 weeks LNP023 200mg BID (n=62) Continue with LNP023 200mg BID Anti-C5 antibody (n= 35) Switch to LNP023 200mg BID 24 weeks D-60 D1 Screening period Randomized treatment period 24 weeks D168 D336 EoS Treatment extension period Population (n = 97) Adult PNH patients with residual anemia (Hb <10g/dL) on a stable regimen of anti-C5 therapy 6 months prior to randomization Primary endpoints Superiority for proportion of patients achieving increase in Hb ≥2g/dL from baseline in the absence of RBC transfusion ☑ Superiority for proportion of patients achieving Hb ≥12g/dL in the absence of RBC transfusion Oral monotherapy iptacopan demonstrates clinically meaningful superiority over anti-C5 treatment in Ph3 Met 2 primary endpoints for superiority in PNH patients with residual anemia despite prior anti-C5 treatment PNH - paroxysmal nocturnal hemoglobinuria Hb - Hemoglobin RBC Red Blood Cell BID twice a day EOS end of study 17 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#18Company overview Financial review 2022 priorities Appendix References Iptacopan has the potential to be a first line, oral complement inhibitor mono-therapy in patients with PNH 3 INNOVATION Unmet need in PNH1-5 Iptacopan PNH value proposition 10-20 cases/million; US 4-6k ☑ Addresses both intra- and extravascular hemolysis, resulting in improvement of Hb levels Potential for lower transfusion requirements ~40% remain anemic (Hb <10g/dl) despite anti-C5 treatments (eculizumab / ravulizumab) -50% of these receive transfusions Potential for improved quality of life Potentially first oral administration, offering significant convenience to patients Potential for broad first line label PNH - Paroxysmal nocturnal hemoglobinuria Hb Hemoglobin 1. Cançado RD, 2021. 2. Jalbert JJ, 2019. 3. Mon Pere N, 2018. 4. Debureaux PE 2021 5. Petropoulou AD 2010. 18 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#19Company overview Financial review 2022 priorities Appendix References Sandoz delivers another quarter of growth Driven by Biopharma and ex-US sales 1 GROWTH Growth rates In cc 2% 8% 5% 4% Q3 sales % cc, USD bn Europe 1.2 (+1%) ROW US 0.6 0.4 (+14%) (-1%) Maintaining leadership in Europe Stabilizing in US Double-digit growth Row 2021 2021 2022 2022 2022 Sales growth driven by biopharmaceuticals -2% Q3 Q4 Q1 Q2 Q3 Solid top line growth; 4th consecutive quarter Russia/Ukraine impact offset by strong growth in rest of Europe Absorbing inflation, M&S investments tied to sales growth 2022 FY guidance revised upwards ■ Sales: Grow low to mid SD (from low SD) Core Oplnc: Grow low SD (from broadly in line) Biosimilars main future growth driver ■ Targeting USD 80bn originator sales (2030) with strong pipeline of 15+ biosimilar assets ■ FDA file acceptance for adalimumab HCF and natalizumab ■ Positive Ph3 results for denosumab Selectively pursuing small molecule opportunities Novartis concluded that separation of Sandoz, via 100% spin-off, is in the best interests of shareholders; completion planned for H2 2023 HCF High concentration formulation 19 Investor Relations | Q3 2022 Results U NOVARTIS | Reimagining Medicine#20Company overview Financial review 2022 priorities Appendix References Harry Kirsch Chief Financial Officer Financial review and 2022 guidance 20 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#21Company overview Financial review 2022 priorities Appendix References Solid Q3 and YTD performance Group1 USD million Q3 Change vs. PY 2022 9M 2022 Change vs. PY % USD % cc % USD % cc Net Sales 12,543 -4 37,855 -1 Core Operating income 4,282 -4 5 12,635 -1 6 Operating income 2,168 -33 -23 7,248 -21 -13 Net Income 1,575 -43 -33 5,489 -29 -20 Growth ex. prior year Roche income -38 -27 -21 -12 Core EPS (USD) 1.58 -8 1 4.60 -6 Growth ex. prior year Roche income 1 10 3 11 EPS (USD) 0.73 -41 -31 2.50 -27 -19 Growth ex. prior year Roche income Free Cash Flow -35 -25 -20 -10 4,169 -6 8,393 -18 Growth ex. prior year Roche dividend -6 -14 1. Core results, constant currencies and free cash flow are non-IFRS measures. Further details regarding non-IFRS measures can be found starting on page 49 of the Condensed Financial Report. A table showing the Q3 2022 and 9M 2022 key figures excluding Roche can be found on page 9 and a reconciliation of 2021 IFRS results and non-IFRS measures core results to exclude the impacts of the 2021 divestment of our Roche investment can be found on page 57 of the Condensed Interim Financial Report. 21 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#22Company overview Financial review 2022 priorities Appendix References Continuing core margin improvements for Group driven by IM Innovative Medicines Sandoz Group Net sales change vs. PY Q3 2022 Core operating 9M 2022 1 income change vs. PY Core margin Core margin change vs. PY Net sales change vs. PY Core operating income change vs. PY Core margin Core margin change vs. PY (in % cc) 1 (in % cc) 1 1 (%) (%pts cc) (in % cc) 1 (in % cc) 1 (%) (%pts cc) 1 4 7 38.1 1.0 5 6 37.1 0.5 4 -5 22.3 -2.2 6 5 21.9 -0.2 4 5 34.1 0.2 5 LO 6 33.4 0.5 IM - Innovative Medicines 1. Constant currencies (cc), core results are non-IFRS measures. An explanation of non-IFRS measures can be found on page 49 of the Condensed Interim Financial Report. 22 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#23Company overview Financial review 2022 priorities Appendix References On track to deliver operational efficiencies Savings of ~USD 1.5bn to be fully embedded by 2024 2022 Minimal impact, offsetting energy costs and inflation pressure in supply chain 23 Investor Relations | Q3 2022 Results ~USD 1.5bn 2023 2024 Integrated Operations unit synergies Simplification of M&S structure (non-customer-facing) Streamlining G&A functions. One-time restructuring cost estimated at 1 to 1.2x annual structural savings NOVARTIS | Reimagining Medicine#24Company overview Financial review 2022 priorities Appendix References 2022 full year guidance Expected, barring unforeseen events; growth vs. PY in cc Innovative Medicines Sales to grow mid single digit Core Oplnc to grow mid to high single digit, ahead of sales Sandoz Group Sales to grow low to mid single digit (revised upwards from to grow low single digit) Core Oplnc to grow low single digit (revised upwards from broadly in line) Sales to grow mid single digit Core Oplnc to grow mid single digit Key assumptions Our guidance assumes that we see a continuing return to normal global healthcare systems, including prescription dynamics, and that no SandostatinⓇ LAR generics enter in the US. In June 2022, an appeals court held the Gilenya US dosing regimen patent invalid. Novartis will file a petition seeking further review with the US Supreme Court, which denied a motion to stay the issuance of the formal appeal mandate while further review is ongoing. FDA-approved Gilenya generics now launched in the US. In Q3, Gilenya US sales were USD 326 million. 24 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#25Company overview Financial review 2022 priorities Appendix References FY 2022 guidance on other financial KPIs Barring unforeseen events; growth vs. PY in cc Group | full year guidance vs. PY (cc) Core Net Financial Result Core Tax Rate 25 Investor Relations | Q3 2022 Results Expenses expected to decrease by around 100-150m vs. 2021 (revised from broadly in line vs. 2021) Core tax rate expected to be around 16.5% (revised from 17-17.5%) NOVARTIS | Reimagining Medicine#26Company overview Financial review 2022 priorities Appendix References Expected currency impact for full year 2022 and 2023 Currency impact vs. PY %pts, assuming late October exchange rates prevail in 2022 and 2023 FX impact on Net sales 2 I I I 2 I FX impact on Core operating income I I I I -4 -4 -5 -6 -8 -7 -6 -7 I -9 -9 -8 I I I -11 I I I FY Q1 Q2 Q3 Q4 FY FY FY Q1 Q2 Q3 Q4 FY ¦ FY I I I I I I I I I I 2021 2022 2023 2021 2022 2023 Actual Simulation 26 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#27Company overview Financial review 2022 priorities Appendix References Vas Narasimhan Chief Executive Officer 27 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#28Company overview Financial review 2022 priorities Appendix References New Novartis: Our strategy Deliver high-value medicines that alleviate society's greatest disease burdens through technology leadership in R&D and novel access approaches Our focus 5 core Therapeutic Areas¹ Cardiovascular, Immunology, Neuroscience, Solid Tumors, Hematology Our priorities Accelerate growth Deliver high-value medicines (including launch excellence) Deliver returns Embed operational excellence 2 + 3 technology platforms Chemistry, Biotherapeutics XRNA, Radioligand, Gene & Cell Therapy 4 priority geographies US, China, Germany, Japan 1. Other TAs opportunistically. Strengthen foundations Unleash the power of our people Scale data science and technology Build trust with society 28 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#29Company overview Financial review 2022 priorities Appendix References Novartis maintains growth momentum, confirms FY 2022 guidance Top 2022 priorities on track 1 Successful launches: Leqvio (laying the foundation), Kesimpta, Pluvicto, Scemblix 2 Maintain growth momentum: YC CE AZ K KL 3 Progress pipeline: Multiple assets with significant sales potential, approval by 2026, on track 4 New focused strategy: Spin Sandoz¹; “pure-play" IM; 5 core TAs²; 2+3 technology platforms³ 5 Deliver returns: Continue productivity initiatives. New organizational model being implemented 6 Strengthen foundations: Culture to drive performance, data science to drive value, ESG leadership IM - Innovative Medicines TAS Therapeutic areas 1. Intention to separate Sandoz via 100% spin-off; completion planned H2 2023. 2. Cardiovascular, immunology, neuroscience, solid tumors, hematology. 3. Two established (chemistry and biotherapeutics), three emerging (gene & cell therapy, radioligand therapy, and XRNA). 29 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#30Company overview Financial performance Financial review Appendix 2022 priorities Innovation: Pipeline overview Appendix Innovation: Clinical trials References Abbreviations 30 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#312022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Company overview Financial review Financial performance References Abbreviations Net debt increased by USD 6.8bn mainly due to dividends and share buybacks, partially offset by FCF (USD bn) -0.9 -7.5 -0.9 -6.8 -7.7 1.1 -7.9 Dec 31, 2021 Dividends M&A transactions Treasury share transactions, net 8.4 Free Cash Flow Others1 Sep 30, 2022 1. Key elements: Currency impact on financial debt and derivative liabilities USD 1.4bn; Payments of lease liabilities USD -0.2bn. 31 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#32Company overview Financial performance Financial review 2022 priorities Appendix Innovation: Clinical trials Innovation: Pipeline overview References Broad pipeline of novel medicines continued to evolve in Q3 Core therapeutic areas Cardiovascular Approvals Immunology Neuroscience 503 Solid tumors Hematology Scemblix® EU: CML 3L KymriahⓇ JP: r/r follicular lymphoma CosentyxⓇ JP: 300mg auto-injector Readouts and publications Abbreviations Iptacopan Canakinumab Tislelizumab Ph3 - PNH UNR844 Ph3 Adjuvant NSCLC (PE not met) Ph3 1L HCC (BeiGene study) Ph2 - Presbyopia (PE not met) Designations and milestones M PluvictoⓇ mCRPC CHMP positive opinion (post Q3) Incl. for Locametz (imaging agent) lanalumab Ph3 Lupus Nephritis SIRIUS-LN initiated lanalumab - Ph3 Sjögren's NEPTUNUS-1 and -2 initiated Submissions CosentyxⓇ Tafinlar® + MekinistⓇ XolairⓇ US: Hidradenitis suppurativa US: Pediatric Low-Grade Glioma (granted FDA priority review) US and EU: Auto-injector Selected milestones PE: Primary Endpoint 32 Investor Relations | Q3 2022 Results 1 NOVARTIS | Reimagining Medicine#33Company overview Financial performance Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials 2022 events¹ (expected) Regulatory decisions NME Lead H1 Pluvicto™ mCRPC (US/EU) H1 VijoiceⓇ PROS (US✓) H2 ScemblixⓇ 3L CML (JP/EU) H2 tislelizumab ESCC 2L (US) 10 H1/H2 JakaviⓇ acute & chronic GVHD (EU /JP) H1/H2 KymriahⓇ r/r follicular lymphoma (US/EU ✓ /JP✓ ) H1/H2 BeovuⓇ DME (US/EU ✓ /JP✓) Submissions H1 ensovibep COVID-19 (US ✓) H1/H2 CosentyxⓇ HS (EU/US ✓) H1/H2 tislelizumab NSCLC (EU/US x²) tislelizumab 1L Nasopharyngeal cancer (US x2) Cosentyx® Psoriatic Arthritis IV (US) canakinumab NSCLC Ph3 CANOPY-A (PE not met) H2 H2 Submissions- H2 enabling H2 readouts TM H2 Pluvicto pre-taxane mCRPC Ph3 PSMAfore³ iptacopan PNH Ph3 APPLY-PNH✓ References Abbreviations ✓ Achieved to plan × Not achieved to plan Other readouts H1 sabatolimab HR-MDS Ph2 √4 H1 CosentyxⓇ Lichen planus Ph2 PRELUDE5 ✓ (PE not met) H1 Cosentyx® axSpA IV Ph3 INVIGORATE-1 ✓ H1 icenticaftor COPD Ph2b √6 H2 UNR844 presbyopia Ph2 READER (PE not met) Ph3/pivotal study starts H1 CosentyxⓇ peripheral SpA x7 H1 OAV101 SMA IT STEER ✓ H1 ensovibep COVID-19 (EMPATHY Part B) x8 H2 JDQ443 NSCLC mono ✓ H2 ianalumab Sjögren's Syndrome ✓ H2 ianalumab Lupus Nephritis ✓ H2 ociperlimab solid tumors H2 TM Pluvicto nmCRPC x11 H2 YTB323 2L DLBCL⁹ H2 OAV101 SMA IT Ph3b STRENGTH PE: Primary Endpoint Note: KisqaliⓇ NATALEE Ph3 readout removed (2023 event as shared at Q1 2023) 1. Selected. 2. No US submission planned. 3. Could move to early 2023. 4. Submission will be based on Ph3 results. 5. Primary endpoint at Wk16 not met. 6. Ph2b DRF demonstrated dose response across multiple endpoints, study results presentation end 2022. Out-licensing planned. 7. Strategy update. 8. No definite start date for the IV Ph3 clinical trial can be provided at this time. 9. Development strategy being updated. 10. FDA deferred action pending completion of required inspections. 11. Ph3 in nmCRPC shifting to Ph2, with FPFV in 2023. 33 Investor Relations | Q3 2022 Results U NOVARTIS | Reimagining Medicine#34Company overview Financial performance Financial review 2022 priorities Innovation: Pipeline overview Appendix Innovation: Clinical trials References Abbreviations Confident in future growth driven by our strength and depth in cardiovascular, immunology, neuroscience... Selected assets, nearly all with exclusivity into 2030+ Cardiovascular Immunology Asset Indication Peak Sales Next Milestone/ Status Submission Asset Indication Peak Sales Next Milestone/ Status Submission Leqvio® CVRR-LDLC Ph3 ORION-4 and VICTORION-2- PREVENT ongoing 2026+ CosentyxⓇ Submitted in US HS Primary prevention initiation GCA Iptacopan1 IgAN Ph3 APPLAUSE-IgAN ongoing 20232 Pelacarsen Neuroscience C3G iMN CVRR-Lp(a) Ph3 APPEAR-C3G ongoing Ph2b ongoing Lupus Nephritis Ph3 GCAPTAIN ongoing Ph3 SELUNE ongoing 2025 2026+ Ph3 Lp(a)HORIZON ongoing 2023 2026+ 2025 Ligelizumab Remibrutinib¹ Food allergy Ph3 ongoing 2025 CSU Ph3 REMIX-1 and -2 ongoing 2024 Asset Indication Peak Sales Next Milestone/ Status Submission lanalumab Other indications being explored Sjögren's ZolgensmaⓇ SMA IT Ph3 STEER ongoing 2025 SLE Ph3 NEPTUNUS-1 and -2 started Ph2a ongoing 2026+ 2026+ Autoimmune hepatitis Ph2b AMBER ongoing 2026+ Branaplam Huntington's disease Ph2b VIBRANT-HD ongoing 2026+ Remibrutinib¹ Multiple sclerosis Ph3 REMODEL-1 and -2 ongoing 2026+ Iscalimab Lupus Nephritis Sjögren's Ph3 SIRIUS-LN started 2026+ DLX313 Parkinson's disease Ph2 ongoing 2026+ HS (UCB0599) Ph2b TWINSS ongoing Ph2a ongoing 2026+ 2026+ Unprobabilized peak sales (USD): <1bn ..1-2bn ... >2bn 'Bold Bets' LNA043 (osteoarthritis: Ph2b ONWARDS ongoing), SAF312 (COSP: Ph2b ongoing) 1. Peak sales potential based on all studied indications. 2. Based on 9 months UPCR readout (US accelerated approval) 34 Investor Relations | Q3 2022 Results ✓ NOVARTIS | Reimagining Medicine#35Company overview Financial performance Financial review 2022 priorities Innovation: Pipeline overview and strength and depth in oncology Appendix Innovation: Clinical trials References Abbreviations Selected assets, nearly all with exclusivity into 2030+ Solid Tumors Hematology Asset Indication Peak Sales Next Milestone/ Status Submission Asset Indication Peak Sales Next Milestone/ Status Submission Kisqali® HR+/HER2- BC (adj) Ph3 NATALEE readout event- driven, expected 2023 2023 Canakinumab NSCLC adjuvant Ph3 CANOPY-A did not meet primary endpoint ScemblixⓇ (asciminib) Iptacopan² CML 3L CML 1L PNH EU Approval Ph3 ongoing 2025 Primary endpoint met (Ph3 2023 APPLY-PNH); readout in 2022 Pluvicto™ mCRPC post-taxane US approved (Ph3 APPOINT-PNH) mCRPC pre-taxane Ph3 PSMAfore readout 2023 aHUS Ph3 ongoing 2025 event-driven, end 20221 Sabatolimab HR-MDS Ph3 STIMULUS-MDS-2 ongoing 2024 mHSPC Ph3 PSMAddition ongoing 2024 JDQ443 2/3L NSCLC (mono) Ph3 ongoing 2024 AML Ph2 STIMULUS-AML-1 ongoing 2026+ KRAS inhibitor NSCLC (Combo) Ph2 ongoing 2026+ TNO155 YTB323 CD19 CAR-T Non-Hodgkin's Lymphoma Plans under review 20254 SHP2 inhibitor Solid tumors: multiple combinations being explored in ongoing trials PHE885 Tislelizumab² 2L esophageal cancer NSCLC Other indications Ociperlimab² NSCLC TIGIT mab Other indications Submitted in EU Submitted in EU BCMA CART-T Multiple myeloma Ph2 ongoing 2025 Ongoing trials Ph3 ongoing³ Ongoing trials; additional Ph3 study initiation H2 2022 Unprobabilized peak sales (USD): <1bn .. 1-2bn ... >2bn 'Bold Bets' NIS793 (1L mPDAC: Ph3 ongoing, 1L metastatic colorectal cancer: Ph2 ongoing) 1. Could move to early 2023. 2. Peak sales potential based on all studied indications; Novartis territories. 3. Active trials are being conducted by BeiGene, option deal. 4. Development strategy being updated. 35 Investor Relations | Q3 2022 Results U NOVARTIS | Reimagining Medicine#36Company overview Financial performance Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Our pipeline projects at a glance Innovative medicines Solid Tumors Hematology Immunology Neuroscience Cardiovascular Others Ophthalmology Respiratory & Allergy Global Health Biosimilars¹ 1. Selected disclosed, internal projects. 36 Investor Relations | Q3 2022 Results References Abbreviations Phase 1/2 Phase 3 Registration Total 97 44 6 147 23 17 3 43 19 6 0 25 22 9 2 33 6 5 0 11 8 19 52 1 14 0 21 5 1 0 6 4 0 0 4 10 1 0 11 0 2 0 2 Total 97 46 6 149 1 NOVARTIS | Reimagining Medicine#37Company overview Financial performance Financial review 2022 priorities Appendix Innovation: Clinical trials Innovation: Pipeline overview Novartis pipeline in Phase 1 Solid tumors Code Name 177Lu-NeoB Ac-PSMA-617 AAA603 AAA817 ADPT01 ADPT01 DFF332 DFF332 DKY709 DKY709 + spartalizumab DYP688 DYP688 IAG933 IAG933 JDQ443 JDQ443 KAZ954 KAZ954 MGY825 MGY825 NIS793 NIS793, spartalizumab NIZ985 NIZ985, spartalizumab NZV930 TNO155 TNO155 VPM087 WNT974 Mechanism Radioligand therapy target GRPR Radioligand therapy target PSMA HIF2A inhibitor Novel immunomodulatory agent GNAQ,GNA11 antagonist. KRAS inhibitor Indication(s) Hematology Name Code Multiple solid tumors ADPT03 Metastatic castration-resistant prostate cancer Colorectal cancer (combos) Renal cell carcinoma Cancers HDM201 ADPT03 HDM201 (combos) JBH492 JBH492 JEZ567 JEZ567 MAK683 MAK683 Unveal melanoma MBG453 sabatolimab Mesothelioma MIK665 MIK665 KRAS G12C mutated solid tumors VAY736 ianalumab + ibrutinib Solid tumors VOB560 VOB560 NSCLC WVT078 WVT078 YTB323 YTB323 NZV930, spartalizumab, NIR178 gevokizumab WNT974+ spartalizumab TGFB inhibitor IL-15 agonist CD73 antagonist SHP2 inhibitor Solid tumors Solid tumors Solid tumors Solid tumors (combo) IL-1 beta antagonist Porcupine inhibitor Solid tumors Colorectal cancer, 1st line Immunology Code Name FIA586 FIA586 MHS552 MHS552 MHV370 MHV370 NG1226 NG1226 Neuroscience Code NIO752 Mechanism Indication(s) Non-alcoholic steatohepatitis (NASH) Autoimmune indications Systemic lupus erythematosus Tendinopathy References Abbreviations 30 lead indications Lead indication Mechanism BCL11A MDM2 inhibitor CD123 CAR-T EED inhibitor TIM3 antagonist MCL1 inhibitor BAFF-R inhibitor CD19 CAR-T Indication(s) Sickle cell anemia Haematological malignancy Haematological malignancy Acute myeloid leukaemia Cancers Low risk myelodysplastic syndrome Hematological malignancies Haematological malignancy (combo) Cancers Multiple myeloma DLBCL and adult ALL Cardiovascular Code XXB750 Name XXB750 Mechanism Indication(s) Cardiovascular diseases Name Mechanism Others Code Global Health EDI048 EDI048 EYU688 EYU688 KAF156 INE963 ganaplacide INE963 Respiratory & Allergy NCJ424 NCJ424 Ophthalmology CpPI(4)K inhibitor NS4B inhibitor Indication(s) Cryptosporidiosis Dengue Malaria prophylaxis Malaria, uncomplicated Respiratory diseases Name NIO752 Mechanism Indication(s) Tau antagonist Progressive supranuclear palsy MHU650 37 Investor Relations | Q3 2022 Results MHU650 Diabetic eye diseases NOVARTIS | Reimagining Medicine#38Company overview Financial performance Financial review 2022 priorities Appendix Innovation: Clinical trials Innovation: Pipeline overview Novartis pipeline in Phase 2 Solid Tumors Code AAA601 Name LutatheraⓇ Mechanism Indication(s) Radioligand therapy target SSTR GEPNET, pediatrics Ad2AR inhibitor, PD1 inhibitor JDQ443 JDQ443 KRAS inhibitor NIR178 NIS793 NIS793 TNO155 TNO155 NIR178, spartalizumab TGFB inhibitor SHP2 inhibitor 1L ES-SCLC Glioblastoma NSCLC (Combo) Cancers 1L metastatic colorectal cancer Solid tumors (single agent) References Abbreviations 27 lead indications Lead indication Hematology Code Name ABL001 ScemblixⓇ INC424 JakaviⓇ LNP023 iptacopan MBG453 sabatolimab PHE885 PHE885 PKC412 Rydapte Cardiovascular Mechanism BCR-ABL inhibitor JAK1/2 inhibitor CFB inhibitor TIM3 antagonist BCMA cell therapy Multi-targeted kinase inhibitor Indication(s) Chronic myeloid leukemia, 2L, pediatrics Acute GVHD, pediatrics Immune thrombocytopenia Unfit acute myeloid leukaemia Acute myeloid leukaemia, maintenance 4L multiple myeloma Acute myeloid leukemia, pediatrics Chronic GVHD, pediatrics Immunology Name Code Mechanism Indication(s) CFZ533 iscalimab CD40 inhibitor CMK389 CMK389 IL-18 inhibitor DFV890 DFV890 NLRP3 inhibitor Sjögren's Atopic dermatitis Osteoarthritis Familial cold auto-inflammatory syndrome LNA043 LNA043 ANGPTL3 agonist Knee osteoarthritis Osteoarthritis (combos) Hidradenitis suppurativa Code Name CFZ533 iscalimab HSY244 HSY244 LNP023 iptacopan Mechanism CD40 inhibitor CFB inhibitor MBL949 MBL949 TIN816 TIN816 ATP modulator LOU064 remibrutinib BTK inhibitor Food allergy Hidradenitis suppurativa Others Sjögren's LRX712 LRX712 Osteoarthritis Code Name Mechanism LYS006 LYS006 Anti-inflammatory Colitis ulcerative Global Health MAS825 MAS825 MHV370 MHV370 NLRC4-GOF indications Sjögren's Hidradenitis suppurativa KAE609 Mixed connective tissue disease KAF156 cipargamin ganaplacide PfATP4 inhibitor VAY736 ianalumab BAFF-R inhibitor Autoimmune hepatitis LXE408 Systemic lupus erythematosus SEG101 SKO136 LXE408 AdakveoⓇ ensovibep Respiratory & Allergy Neuroscience Code ADPT06 ADPT06 CMK389 Name Mechanism Indication(s) LTP001 Cognitive impairment QMF149 CMK389 LTP001 AtecturaⓇ IL-18 inhibitor SMURF1 inhibitor Combo BLZ945 DLX313 LMI070 sotuletinib DLX313 (UCB0599) branaplam CSF-1R inhibitor Amyotrophic lateral sclerosis Ophthalmology Alpha-synuclein Inhibitor mRNA splicing modulator Parkinson's disease LKA651 Huntington's disease² LNP023 LKA651 iptacopan EPO inhibitor CFB inhibitor MIJ821 MIJ821 NR2B negative allosteric modulator Major depressive disorder with acute suicidal ideation or behavior PPY9881 PPY988 Gene therapy SAF312 Libvatrep TRPV1 antagonist 1. Gyroscope acquisition. 2. Plan update ongoing. 38 Investor Relations | Q3 2022 Results Indication(s) Lupus nephritis Type 1 diabetes mellitus Atrial fibrillation Membranous nephropathy Lupus nephritis Obesity related diseases Acute kidney injury Proteasome inhibitor P-selectin inhibitor Multi-specific DARPin Indication(s) Malaria, uncomplicated Malaria, severe Malaria, uncomplicated Visceral leishmaniasis Sickle cell disease, pediatrics Corona virus infection Pulmonary sarcoidosis PAH Asthma, pediatrics Diabetic retinopathy iAMD Geographic atrophy Chronic ocular surface pain U NOVARTIS | Reimagining Medicine#39Company overview Financial performance Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Novartis pipeline in Phase 3 References Abbreviations 9 lead indications Lead indication Mechanism BCR-ABL inhibitor Thrombopoietin receptor (TPO-R) agonist CFB inhibitor Indication(s) Chronic myeloid leukemia, 1st line Radiation sickness syndrome Paroxysmal nocturnal haemoglobinuria Atypical haemolytic uraemic syndrome Myelodysplastic syndrome 2L Diffuse large B-cell lymphoma²) Solid Tumors Code AAA617 Name Mechanism Indication(s) Hematology Code Name PluvictoⓇ Radioligand therapy target PSMA mCRPC, pre-taxane ABL001 AAA6011) Lutathera® Metastatic hormone sensitive prostate cancer (mHSPC) Radioligand therapy target SSTR Gastroenteropancreatic neuroendocrine tumors, 1st line in G2/3 tumors (GEP-NET 1L G3) ETB115 ScemblixⓇ PromactaⓇ LNP023 iptacopan BYL719 JDQ443 PiqrayⓇ JDQ443 PI3Ka inhibitor HER2+ adv BC Triple negative breast cancer Ovarian cancer KRAS inhibitor LEE011 Kisqali® NIS793 NIS793 CDK4/6 Inhibitor TGFB1 inhibitor 2/3L Non-small cell lung cancer HR+/HER2- BC (adj) MBG453 YTB323 sabatolimab YTB323 TIM3 antagonist CD19 CAR-T 1L Metastatic pancreatic ductal adenocarcinoma VDT482 Tislelizumab PD1 inhibitor 1L Nasopharyngeal Carcinoma 1L ESCC Adj/Neo adj. NSCLC 1L Gastric cancer Cardiovascular 1L Hepatocellular Carcinoma Localized ESCC Code Name 1L Urothelial Cell Carcinoma 1L Small Cell Lung Cancer KJX839 LeqvioⓇ LNP023 iptacopan CFB inhibitor Immunology Code Name AIN457 Cosentyx® Mechanism IL17A inhibitor BTK inhibitor BAFF-R inhibitor Indication(s) Lupus Nephritis Psoriatic arthritis (IV formulation) Axial SpA (IV formulation) Giant cell arteritis Food allergy Chronic spontaneous urticaria Food allergy Sjögren's Lupus Nephritis IGE025 LOU064 Xolair IgE inhibitor remibrutinib QGE031 ligelizumab IgE inhibitor VAY736 ianalumab Neuroscience Code Name AMG334 AimovigⓇ BAF312 Mayzent® LOU064 remibrutinib OAV101 AVXS-101 OMB157 KesimptaⓇ Mechanism CGRPR antagonist S1P1,5 receptor modulator BTK inhibitor Indication(s) Migraine, pediatrics Multiple sclerosis, pediatrics Multiple sclerosis SMN1 gene replacement therapy SMA IT administration CD20 Antagonist Multiple sclerosis, pediatrics 1. 177 Lu-dotatate in US. 2. Ph3 to be initiated pending strategy update. 39 Investor Relations | Q3 2022 Results Mechanism siRNA (regulation of LDL-C) TQJ230 Pelacarsen ASO targeting Lp(a) Indication(s) CVRR-LDLC IgA nephropathy Hyperlipidemia, pediatrics C3 glomerulopathy Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a) (CVRR-Lp(a)) Others Code Global Health COA566 Coartem® Ophthalmology RTH258 BeovuⓇ Name Mechanism VEGF inhibitor Biosimilars Code Name GP2411 denosumab SOK583 aflibercept Mechanism anti RANKL mAb VEGF inhibitor Indication(s) Malaria, uncomplicated (<5kg patients) Diabetic retinopathy Indication(s) Osteoporosis (same as originator) Ophthalmology indication (as originator) NOVARTIS | Reimagining Medicine#40Company overview Financial performance Financial review 2022 priorities Appendix Innovation: Clinical trials Innovation: Pipeline overview Novartis pipeline in registration Solid Tumors Code Name VDT482 Tislelizumab DRB436 Tafinlar® +MekinistⓇ Immunology Mechanism PD1 inhibitor BRAF inhibitor + MEK inhibitor Code Name Mechanism AIN457 IGE025 CosentyxⓇ XolairⓇ IL17A inhibitor IgE inhibitor 1. Approved in US. Indication(s) 2L ESCC Non-small cell lung cancer HGG/LGG, pediatrics Indication(s) Hidradenitis suppurativa Auto-injector Cardiovascular Code LCZ696 Name Entresto® References Abbreviations 1 lead indication Mechanism Indication(s) Angiotensin receptor/neprilysin Congestive heart failure, pediatrics1) inhibitor Lead indication 40 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#41NEW INDICATIONS Company overview Financial performance Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Novartis submission schedule New Molecular Entities: Lead and supplementary indications LEAD INDICATIONS References Abbreviations 2022 2023 2024 ensovibep Lead iptacopan Lead JDQ443 Lead 2025 ligelizumab ≥2026 Lead 177 Lu-NeoB Lead iscalimab Lead SKO136 COVID19 LNP023 PNH JDQ443 QGE031 AAA603 CFZ533 MIJ821 Acute depression Lead 2/3L NSCLC (mono) Food allergy Multiple Solid Tumors Sjögren's syndrome sabatolimab Lead NIS793 Lead branaplam¹ Lead ianalumab Lead PPY9883 Lead MBG453 1L Pancreatic cancer LMI070 VAY736 Geographic atrophy HR-MDS Huntington's disease Sjögren's syndrome remibrutinib Lead pelacarsen Lead cipargamin Lead libvatrep Lead TNO155 Lead LOU064 TQJ230 KAE609 SAF312 Solid tumors CSU CVRR-Lp(a) Malaria severe COSP YTB3231 Lead ganaplacide Lead LNA043 Lead 2L Diffuse large B-cell lymphoma KAF156 Knee osteoarthritis Malaria uncomplicated gevokizumab Lead LXE408 Lead VPM087 Visceral leishmaniasis 1st line CRC tislelizumab LCM Pluvicto LCM Pluvicto LCM Scemblix LCM cipargamin LCM ianalumab LCM remibrutinib LCM VDT482 AAA617 AAA617 ABL001 KAE609 VAY736 LOU064 NSCLC mCRPC, Pre-taxane mHSPC CML 1L Malaria uncomplicated SLE Sjögren's syndrome iptacopan LCM tislelizumab LCM iptacopan LCM JDQ443 LCM LNP023 VDT482 LNP023 JDQ443 iptacopan LNP023 LCM remibrutinib LCM LOU064 C3G 1L Small Cell Lung Cancer aHUS NSCLC (combo) iMN Multiple sclerosis iptacopan LCM ianalumab LCM sabatolimab LCM tislelizumab LCM LNP023 VAY736 MBG453 VDT482 IgAN AIH Unfit AML Adj/Neo adj NSCLC tislelizumab LCM ianalumab LCM Scemblix LCM tislelizumab LCM VDT482 VAY736 ABL001 VDT482 1L Gastric Cancer Lupus Nephritis CML, 2L, pediatrics 1L Urothelial Cell Carcinoma tislelizumab LCM VDT482 1L ESCC tislelizumab LCM VDT482 Localized ESCC tislelizumab LCM VDT482 1L Hepatocellular Carcinoma tislelizumab LCM VDT482 1L Nasopharyngeal Carcinoma 1. Development strategy being updated. 2. Plan update on-going. 3. Gyroscope acquisition. 41 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#42Company overview Financial performance Financial review 2022 priorities Innovation: Pipeline overview Novartis submission schedule Supplementary indications for existing brands EXISTING BRANDS Appendix Innovation: Clinical trials References Abbreviations 2022 2023 2024 2025 ≥2026 Cosentyx secukinumab, AIN457 LCM Cosentyx LCM aflibercept BioS Beovu LCM Atectura LCM Kesimpta³ LCM Piqray LCM secukinumab, AIN457 SOK583 PSA IV axSpA IV Ophthalmology indication (as originator) brolucizumab, RTH258 Diabetic retinopathy indacaterol + mometasone, QMF149 Asthma, pediatrics ofatumumab Multiple sclerosis, pediatrics Cosentyx LCM denosumab BioS Adakveo LCM Cosentyx LCM Aimovig LCM Leqvio LCM secukinumab, AIN457 GP2411 SEG101 secukinumab, AIN457 erenumab, AMG334 KJX839 alpelisib, BYL719 TNBC Rydapt midostaurin, PKC412 LCM Hidradenitis suppurativa Osteoporosis (same as originator) Sickle cell disease, pediatrics. GCA Pediatric Migraine CVRR-LDLC Acute myeloid leukemia, pediatrics Entresto EU¹ LCM Kisqali LCM Coartem LCM Leqvio LCM Cosentyx LCM Mayzent³ LCM sacubitril/valsartan, LCZ696 ribociclib, LEE011 Pediatric CHF HR+/HER2- BC (adj) artemether + lumefantrine, COA566 Malaria uncompl., formula for <5kg KJX839 secukinumab, AIN457 siponimod, BAF312 Ped Hyperlipidemia Lupus Nephritis Multiple sclerosis, pediatrics Tafinlar + Mekinist LCM Lutathera LCM Jakavi LCM Piqray LCM dabrafenib + trametinib, DRB436 177Lu-oxodotreotide² ruxolitinib, INC424 alpelisib, BYL719 HGG/LGG Pediatrics GEP-NET 1L G3 Pediatrics Acute GVHD HER2+ adv BC Xolair omalizumab, IGE025 LCM Piqray LCM Jakavi LCM Promacta LCM alpelisib, BYL719 ruxolitinib, INC424 eltrombopag, ETB115 Auto-injector Ovarian cancer Pediatrics Chronic GVHD Radiation sickness syndrome Xolair LCM Zolgensma LCM omalizumab, IGE025 AVXS-101 OAV101 Food allergy SMA IT 1. Approved in US. 2. 177Lu-dotatate in US. 42 Investor Relations | Q3 2022 Results 3. Kesimpta and Mayzent: pediatric study in multiple sclerosis run in conjunction (NEOS). NOVARTIS | Reimagining Medicine#43Company overview Financial review Financial performance Cardiovascular Immunology 2022 priorities Innovation: Pipeline overview Neuroscience Appendix Innovation: Clinical trials Clinical Trials Update Includes selected ongoing or recently concluded global trials of Novartis development programs/products which are in confirmatory development or marketed (typically Phase 2b or later). For further information on all Novartis clinical trials, please visit: www.novartisclinicaltrials.com Oncology References Abbreviations Other 43 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#44Company overview Financial review Financial performance Cardiovascular Immunology 2022 priorities Innovation: Pipeline overview Cardiovascular Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 44 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#45Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology iptacopan - CFB inhibitor NCT03955445 (CLNP023B12001B) iptacopan - CFB inhibitor NCT04154787 (CLNP023D12201) Indication Idiopathic membranous nephropathy (IMN) References Abbreviations Other Indication C3 glomerulopathy (C3G) Phase Phase 2 Phase Phase 2 Patients 27 patients from ongoing Ph2 (sample size from Ph3 pending HA discussions Q1 2021), total patients for this study will increase Patients 72 Primary Outcome Measures Arms Intervention Target Patients Characterize the effect of LNP023 treatment on a composite renal response endpoint at 9 months (1. a stable or improved eGFR and, 2. a reduction in proteinuria and 3. an increase in C3 compared to the CLNP023X2202 baseline visit) Open-label LNP023 200mg bid Patients with C3 glomerulopathy Primary Outcome Measures Change from baseline of UPCR derived from 24hr urine collections at Baseline and Week 24 Arms Intervention LNP023 low dose LNP023 high dose Target Patients Read-out Milestone(s) 2025 Read-out Milestone(s) Publication 2023 TBD Publication Wong et al 2021 Nephrology, Dialysis and Transplantation Vol. 36, Suppl. 1: eGFR trajectory Rituximab Patients with biopsy proven iMN who are at high risk of disease progression defined on the basis of antibody anti-PLA2R titre and proteinuria 45 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#46Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology iptacopan - CFB inhibitor NCT04578834 APPLAUSE-IgAN (CLNP023A2301) Indication Phase IgA nephropathy Phase 3 iptacopan - CFB inhibitor NCT04817618 APPEAR-C3G (CLNP023B12301) Indication C3 glomerulopathy Phase 3 References Abbreviations Other Log-transformed ratio to baseline in UPCR (sampled from a 24 hour urine collection) Experimental: iptacopan 200mg b.i.d. Placebo Comparator: Placebo to iptacopan 200mg b.i.d. Patients with native C3G Phase Patients 450 Patients 68 Primary Outcome Ratio to baseline in urine protein to creatinine ratio (sampled from 24h urine collection) at 9 months Measures Read-out Milestone(s) Publication Arms Intervention Target Patients Annualized total estimated Glomerular Filtration Rate (eGFR) slope estimated over 24 months Arm 1 - LNP023 200mg BID Arm 2 - Placebo BID Primary IgA Nephropathy patients 2023 (primary endpoint for US initial submission, 9 months UPCR) 2025 (24 months) Perkovic et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1: Study Design Wong et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1: IPTACOPAN (LNP023): A NOVEL ORAL COMPLEMENT ALTERNATIVE PATHWAY FACTOR B INHIBITOR SAFELY AND EFFECTIVELY STABILISES EGFR IN C3 GLOMERULOPATHY Primary Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) 2023 Publication TBD 46 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#47Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology Leqvio® - siRNA (regulation of LDL-C) NCT03705234 ORION-4 (CKJX839B12301) References LeqvioⓇ - siRNA (regulation of LDL-C) Abbreviations Other NCT03814187 ORION-8 (CKJX839A12305B) Indication Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH) and Homozygous Familial Hypercholesterolemia (HoFH) Phase 3 Indication Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH) Phase Phase 3 Phase Patients 15000 Patients 3275 Primary Outcome Measures A composite of major adverse cardiovascular events, defined as: Coronary heart disease (CHD) death; Myocardial infarction; Primary Outcome Measures Arms Intervention Target Patients Arms Intervention Fatal or non-fatal ischaemic stroke; or Urgent coronary revascularization procedure Arm 1: every 6 month treatment Inclisiran sodium 300mg (given by subcutaneous injection on the day of randomization, at 3 months and then every 6-months) for a planned median duration of about 5 years Arm 2: matching placebo (given bysubcutaneous injection on the day of randomization, at 3 months and then every 6- months) for a planned median duration of about 5 years. Patient population with mean baseline LDL-C ≥ 100mg/dL Target Patients Read-out Milestone(s) 2026 Publication TBD 47 Investor Relations | Q3 2022 Results Proportion of subjects achieving prespecified low density lipoprotein cholesterol (LDL-C) targets at end of study Safety and tolerability profile of long term use of inclisiran Inclisiran sodium 300mg on Day 90 and every 180 days for a planned duration of 3 years Patients with HeFH or pre-existing atherosclerotic cardiovascular disease (ASCVD) on background statin +/- ezetimibe therapy and risk equivalents (patients from ORION 3, 9, 10 & 11 studies) Read-out Milestone(s) 2023 Publication TBD NOVARTIS | Reimagining Medicine#48Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology Leqvio® - siRNA (regulation of LDL-C) NCT04652726 ORION-16 (CKJX839C12301) References LeqvioⓇ - siRNA (regulation of LDL-C) NCT04659863 ORION-13 (CKJX839C12302) Hyperlipidemia, pediatrics Indication Hyperlipidemia, pediatrics Indication Phase Phase 3 Phase Phase 3 Patients 150 Patients 12 Primary Outcome Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 330 Primary Outcome Measures Measures Arms Group 1: Inclisiran sodium 300mg on Days 1, 90, 270, placebo on Day 360, inclisiran sodium 300mg on Days 450 and 630 Arms Intervention Intervention Group 2: Placebo on Days 1, 90, 270, inclisiran sodium 300mg on Days 360, 450 and 630. Adolescents (12 to less than 18 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol Target Patients (LDL-C) Read-out Milestone(s) 2025 Publication Design publication in Eur. J. Prev. Cardiol. Vol. 29, Feb. 2022; Presentation at EAS May-2022 48 Investor Relations | Q3 2022 Results Abbreviations Other Target Patients Read-out Milestone(s) Publication Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from baseline to day 330 Group 1: Inclisiran sodium 300mg on Days 1, 90, 270, placebo on Day 360, inclisiran sodium 300mg on Days 450 and 630. Group 2: Placebo on Days 1, 90, 270, inclisiran sodium 300mg on Days 360, 450 and 630. Adolescents (12 to less than 18 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C) 2025 Design publication in Eur. J. Prev. Cardiol. Vol. 29, Feb. 2022; Presentation at EAS May-2022 NOVARTIS | Reimagining Medicine#49Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology Leqvio® - siRNA (regulation of LDL-C) NCT05030428 VICTORION-2P (CKJX839B12302) Indication Phase Patients Primary Outcome Measures Arms Intervention Secondary prevention of cardiovascular events in patients with elevated levels of LDL-C Phase 3 15000 1. Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events) Arm 1: Experimental Inclisiran sodium, Subcutaneous injection Arm 2: Placebo Comparator, Placebo Subcutaneous injection Participants with established cardiovascular disease (CVD) Target Patients Read-out 2027 Milestone(s) Publication TBD References Abbreviations Other 49 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#50Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology pelacarsen - ASO targeting Lp(a) NCT04023552 Lp(a)HORIZON (CTQJ230A12301) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein(a) Phase 3 8323 Time to the first occurrence of MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization) TQJ230 80 mg injected monthly subcutaneously or matched placebo Patients with a history of Myocardial infarction or Ischemic Stroke, or a clinically significant symptomatic Peripheral Artery Disease, and Lp(a) ≥ 70 mg/dL 2025 Read-out Milestone(s) Publication TBD 50 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#51Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology Immunology References Abbreviations Other 51 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#52Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology Cosentyx® - IL-17A inhibitor Cosentyx®Ⓡ - IL-17A inhibitor NCT04181762 SELUNE (CAIN457Q12301) Indication Lupus Nephritis Phase Phase 3 NCT04930094 GCAPTAIN (CAIN457R12301) Indication Phase Giant cell arteritis Phase 3 Patients 460 Patients 348 Primary Proportion of subjects achieving protocol-defined CRR Outcome Primary Outcome Number of participants with sustained remission Measures Measures Arms Secukinumab 300 mg s.c. Intervention Placebo s.c. Target Patients Patients with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features) Target Patients Experimental: Secukinumab 300 mg Placebo Comparator: Placebo Patients with Giant Cell Arteritis (GCA) Primary 2025 Arms Intervention Read-out Milestone(s) 2026 Publication 2026 Read-out Milestone(s) Final 2026 Publication TBD 52 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#53Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology ianalumab - BAFF-R inhibitor NCT03217422 AMBER (CVAY736B2201) Indication Autoimmune hepatitis Phase 2 Phase Patients 80 Primary Alanine aminotransferase (ALT) normalization Outcome Measures Arms VAY736 Intervention Placebo control with conversion to active VAY736 Autoimmune hepatitis patients with incomplete response or intolerant to standard treatment of care Target Patients Read-out 2026 Milestone(s) Publication TBD 53 Investor Relations | Q3 2022 Results ianalumab - BAFF-R inhibitor NCT05126277 SIRIUS-LN (CVAY736K12301) Indication Lupus Nephritis Phase 3 Phase Patients 420 Primary Outcome Measures Arms Intervention References Abbreviations Other Frequency and percentage of participants achieving complete renal response (CRR) [ Time Frame: week 72] Arm 1: Experimental - ianalumab s.c. q4w in addition to standard of care (SoC) Arm 2: Experiemntal - ianalumab s.c. q12w in addition to SoC Arm 3: Placebo comparator - Placebo s.c. q4w in addition to SoC Parients with active Lupus Nephritis Target Patients Read-out Milestone(s) Primary 2027 Publication TBD NOVARTIS | Reimagining Medicine#54Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology ianalumab - BAFF-R inhibitor ianalumab - BAFF-R inhibitor References Abbreviations Other Indication Phase NCT05349214 NEPTUNUS-2 (CVAY736A2302) Sjögren's syndrome Phase 3 Indication NCT05350072 NEPTUNUS-1 (CVAY736A2301) Sjögren's syndrome Phase Phase 3 Patients 489 Patients 268 Primary Outcome Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Measures Primary Outcome Measures Target Patients Arms Intervention Arm 1: Experimental - ianalumab exposure level 1 Arm 2: Experimental - ianalumab exposure level 2 Arm 3: Placebo comparator Patients with active Sjogren's syndrome Arms Intervention Target Patients Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Arm 1: Experimental - ianalumab Arm 2: Placebo comparator Patients with active Sjogren's syndrome Read-out Primary 2026 Milestone(s) Publication TBD Read-out Milestone(s) Primary 2026 Publication TBD 54 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#55Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology iscalimab - CD40 inhibitor Indication Phase NCT03905525 TWINSS (CCFZ533B2201) Sjögren's syndrome Phase 2 Patients 260 Primary Outcome Measures Change in EULAR Sjögren's syndrome Disease Activity Index (ESSDAI) score and EULAR Sjögren's syndrome Patient Reported Index (ESSPRI) score Arms Intervention Target Patients Three dose arms of CFZ533 Placebo Patients with Sjögren's syndrome Read-out Milestone(s) 2022 Publication 2023 References Abbreviations Other 55 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#56Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology ligelizumab - IgE Inhibitor NCT04984876 (CQGE031G12301) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Food allergy Phase 3 486 1. Proportion of participants who can tolerate a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 Arm 1: ligelizumab 240 mg subcutaneous injection for 52 weeks Arm 2: ligelizumab 120 mg subcutaneous injection for 52 weeks Arm 3: Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks Arm 4: Placebo 16 weeks and ligelizumab 120 mg/240 mg subcutaneous injection for 36 weeks Arm 5: Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks Participants with a medically confirmed diagnosis of IgE-mediated peanut allergy Read-out Milestone(s) 2025 Publication TBD 56 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#57Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology LNA043 - ANGPTL3 agonist NCT04864392 ONWARDS (CLNA043A12202) Knee osteoarthritis Phase 2 Indication Phase Patients 550 Primary Outcome Measures Arms Intervention Target Patients Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging LNA043 injection to the knee with dosing regimen A LNA043 injection to the knee with dosing regimen B LNA043 injection to the knee with dosing regimen C LNA043 injection to the knee with dosing regimen D Placebo injection to the knee Patients with Symptomatic knee osteoarthritis Primary 2024 Read-out Milestone(s) Publication TBD References Abbreviations Other 57 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#58Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology remibrutinib - BTK inhibitor NCT05030311 REMIX-1 (CLOU064A2301) Chronic spontaneous urticaria Phase 3 Indication Phase Patients 450 Primary Outcome Measures Arms Intervention Target Patients Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint) Arm 1: LOU064 (blinded) LOU064 (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2). Arm 2: LOU064 placebo (blinded) LOU064 placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2). Adult Chronic Spontaneous Urticaria (CSU) patients inadequately controlled by H1-antihistamines 2024 Read-out Milestone(s) Publication TBD 58 Investor Relations | Q3 2022 Results remibrutinib - BTK inhibitor NCT05032157 REMIX-2 (CLOU064A2302) Chronic spontaneous urticaria Phase 3 Indication Phase Patients 450 Primary Outcome Measures Arms Intervention Target Patients References Abbreviations Other 1. Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint) 2. Absolute change in ISS7 an absolute change in HSS7 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints) Arm 1: LOU064 (blinded) LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks Arm 2: LOU064 placebo (blinded) LOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks Eligible participants randomized to the treatment arms in a 2:1 ratio (arm 1: arm 2) Adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo Read-out Milestone(s) Publication 2024 Primary 2025 1 NOVARTIS | Reimagining Medicine#59Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology Neuroscience References Abbreviations Other 59 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#60Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology branaplam-mRNA splicing modulator NCT05111249 VIBRANT-HD (CLMI070C12203) Indication Phase Huntington's disease Phase 2B 1. Reduction (%) of mHTT protein in cerebrospinal fluid (CSF) Patients 75 Primary Outcome Measures Arms Intervention Target Patients 2. Number of treatment emergent adverse events and serious adverse events Arm 1: Experimental; Branaplam 56 mg oral solution once weekly Arm 2: Experimental; Branaplam 112 mg oral solution once weekly Arm 3: Experimental; (C) Branaplam 154 mg oral solution once weekly, OR (X) Branaplam 84 mg oral solution once weekly OR (Y) Branaplam 28 mg oral solution once weekly Arm 4: Placebo; Matching placebo oral solution once weekly Participants with early manifest Huntington's Disease Read-out Milestone(s) 2025 Publication TBD 60 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#61Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology MayzentⓇ - S1P1,5 receptor modulator NCT04926818 NEOS (CBAF312D2301) Indication Phase Multiple sclerosis, pediatrics Phase 3 Patients 180 Primary Outcome Measures Annualized relapse rate (ARR) in target pediatric participants Arms Intervention Target Patients Arm 1: Experimental ofatumumab - 20 mg injection/ placebo Arm 2: Experimental siponimod - 0.5 mg, 1 mg or 2 mg/ placebo Arm 3: Active Comparator fingolimod - 0.5 mg or 0.25 mg/ placebo Children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The targeted enrollment is 180 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years. Read-out Milestone(s) 2026 Publication TBD 61 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#62Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology MIJ821 - NR2B negative allosteric modulator (NAM) NCT04722666 (CMIJ821A12201) Major depressiv disorder with acute suicidal ideation or behavior Phase 2 Indication Phase Patients 195 Primary Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) Change from baseline to 24 hours in the total score of the Montgomery Åsberg Depression Rating Scale (MADRS) MIJ821 (mg/kg) very low dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29 MIJ821 (mg/kg) low dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29 MIJ821 (mg/kg) high dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29 MIJ821 (mg/kg) very high dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29 Placebo 40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29 MIJ821 (mg/kg) high dose for 40 minutes IV infusion on Day 1 followed by Placebo 40 minutes IV infusion of 0.9% sodium chloride on Day 15 and Day 29 MIJ821 (mg/kg) very high dose for 40 minutes IV infusion on Day 1 followed by Placebo 40 minutes IV infusion of 0.9% sodium chloride on Day 15 and Day 29 Participants who have suicidal ideation with intent 2023 Publication TBD 62 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#63Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology remibrutinib - BTK inhibitor remibrutinib - BTK inhibitor References Indication NCT05147220 REMODEL-1 (CLOU064C12301) Multiple sclerosis Indication NCT05156281 REMODEL-2 (CLOU064C12302) Multiple sclerosis Phase Phase 3 Phase Phase 3 Patients 800 Patients 800 Primary Outcome Measures Annualized relapse rate (ARR) of confirmed relapses [Core Part]. ARR is the average number of confirmed MS relapses in a year Primary Outcome Measures Annualized relapse rate (ARR) of confirmed relapses Arms Intervention Arm 1: Experimental; Remibrutinib - Core (Remibrutinib tablet and matching placebo of teriflunomide capsule) Arms Arm 1: Experimental; Remibrutinib - Core Intervention Arm 2: Active Comparator; Teriflunomide - Core (Teriflunomide capsule and matching placebo remibrutinib tablet) Arm 3: Experimental; Remibrutinib - Extension (Participants on remibrutinib in Core will continue on remibrutinib tablet) Arm 4: Experimental; Remibrutinib - Extension (on teriflunomide in Core) (Participants on teriflunomide in Core will switch to remibrutinib tablet) Patients with relapsing Multiple Sclerosis Estimated primary completion 2026 Target Patients Read-out Milestone(s) Publication TBD 63 Investor Relations | Q3 2022 Results Abbreviations Other Remibrutinib tablet and matching placebo of teriflunomide capsule Arm 2: Active Comparator; Teriflunomide - Core Teriflunomide capsule and matching placebo remibrutinib tablet Arm 3: Experimental: Remibrutinib - Extension Participants on remibrutinib in Core will continue on remibrutinib tablet Arm 4: Experimental: Remibrutinib - Extension (on teriflunomide in Core) Participants on teriflunomide in Core will switch to remibrutinib tablet Patients with relapsing Multiple Sclerosis Estimated primary completion 2026 Target Patients Read-out Milestone(s) Publication TBD 1 NOVARTIS | Reimagining Medicine#64Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology ZolgensmaⓇ - SMN1 gene replacement therapy References Abbreviations Other ZolgensmaⓇ - SMN1 gene replacement therapy NCT05089656 STEER (COAV101B12301) Indication Spinal muscular atrophy (IT administration) Phase 3 Phase Patients 125 Primary Outcome Measures Arms Intervention Target 1. Change from baseline in Hammersmith functional motor scale - Expanded (HFMSE) total score at the end of follow-up period 1 in treated patients compared to sham controls in the ≥ 2 to < 18 years age group Arm 1: Experimental OAV101. Administered as a single, one-time intrathecal dose Arm 2: Sham Comparator: Sham control. A skin prick in the lumbar region without any medication. Patients Type 2 Spinal Muscular Atrophy (SMA) who are ≥ 2 to < 18 years of age, treatment naive, sitting, and never ambulatory NCT05386680 STRENGTH (COAV101B12302) Spinal muscular atrophy (IT administration) Phase 3B Indication Phase Patients 28 Primary Outcome Measures Arms Intervention Target Patients Number and percentage of participants reporting AEs, related AES, SAES, and AESIS [ Time Frame: 52 weeks ] Experimental: OAV-101 Single intrathecal administration of OAV101 at a dose of 1.2 x 10^14 vector genomes Participants with SMA who discontinued treatment With Nusinersen or Risdiplam (STRENGTH) Patients Read-out Milestone(s) 2024 Publication TBD 64 Investor Relations | Q3 2022 Results Read-out Milestone(s) 2024 Publication TBD NOVARTIS | Reimagining Medicine#65Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology Oncology References Abbreviations Other 65 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#66Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology iptacopan - CFB inhibitor iptacopan - CFB inhibitor References Abbreviations Other NCT04558918 APPLY-PNH (CLNP023C12302) Paroxysmal nocturnal haemoglobinuria Indication Phase Phase 3 Patients 91 Primary Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) Publication Percentage of participants achieving a sustained increase in hemoglobin levels of ≥ 2 g/dL in the absence of red blood cell transfusions Percentage of participants achieving sustained hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions Arm 1: Drug: LNP023, taken orally b.i.d. dosage supplied: 200 mg dosage form: hard gelatin capsule Route of Administration: Oral Arm 2: Drug: Eculizumab, administered as intravenous infusion every 2 weeks as per the stable regimen, the maintenance dose is a fixed dose. Dosage supplied: 300 mg/30mL Dosage form: Concentrate solution for infusion Drug: Ravulizumab, administered as intravenous infusion every 8 weeks, the maintenance dose is based on body weight. Dosage Supplied: 300 mg/30mL Dosage form: Concentrate solution for infusion Adult patients with PNH and residual anemia, despite treatment with an intravenous Anti-C5 antibody Primary 2022 Risitano AM, et al. Abstract accepted at the European Hematology Association (EHA 2021) congress (study design abstract; accepted for publication only) NCT04820530 APPOINT-PNH (CLNP023C12301) Indication Phase Paroxysmal nocturnal haemoglobinuria Phase 3 Patients 40 Primary Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) Publication Proportion of participants achieving a sustained increase from baseline in hemoglobin levels of ≥2 g/dL assessed, in the absence of red blood cell transfusions Iptacopan (LNP023), taken orally b.i.d. (dosage supplied: 200mg) PNH patients who are naive to complement inhibitor therapy, including anti- C5 antibody 2022 Peffault de Latour R, et al. Abstract accepted at the European Hematology Association (EHA 2021) congress (study design abstract; accepted for publication only) 66 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#67Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology iptacopan - CFB inhibitor NCT04889430 APPELHUS (CLNP023F12301) Indication Phase Atypical haemolytic uraemic syndrome Phase 3 Patients 50 Primary Outcome Percentage of participants with complete TMA response without the use of PE/PI and anti-C5 antibody Measures Arms Intervention Target Patients Single arm open-label with 50 adult patients receiving 200mg oral twice daily doses of iptacopan Adult patients with aHUS who are treatment naive to complement inhibitor therapy (including anti-C5 antibody) Read-out Milestone(s) 2024 Publication TBD References Abbreviations Other 67 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#68Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology JakaviⓇ-JAK1/2 inhibitor NCT03491215 REACH4 (CINC424F12201) Indication Acute graft versus host disease Phase 2 Phase Patients 45 Primary Measurement of PK parameters Outcome Measures Overall Response Rate (ORR) Arms Ruxolitinib Intervention Target Pediatric patients with grade II-IV acute graft vs. host disease after allogeneic hematopoietic stem cell transplantation Patients Read-out 2023 Milestone(s) Publication TBD 68 Investor Relations | Q3 2022 Results JakaviⓇ - JAK1/2 inhibitor References Abbreviations Other NCT03774082 REACH5 (CINC424G12201) Indication Phase Chronic graft versus host disease Phase 2 Patients 45 Primary Overall Response Rate (ORR) Outcome Measures Arms Intervention Target Patients Ruxolitinib 5mg tablets / pediatric formulation Pediatric subjects with moderate and severe chronic Graft vs. Host disease after allogeneic stem cell transplantation Read-out Milestone(s) Publication 2023 TBD NOVARTIS | Reimagining Medicine#69Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology JDQ443-KRAS inhibitor NCT05132075 KontRASt-02 (CJDQ443B12301) Indication Non-small cell lung cancer, 2/3L Phase Phase 3 Patients 360 Primary Progression free survival (PFS) Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) Arm 1 Experimental: JDQ443 Arm 2 Active Comparator: Participant will be treated with docetaxel following local guidelines as per standard of care and product labels Patients with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum- based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination. 2024 Publication NA 69 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#70Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology KisqaliⓇ - CDK4 inhibitor NCT03701334 NATALEE (CLEE011012301C) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Adjuvant treatment of hormone receptor (HR)-positive, HER2-negative, early breast cancer (EBC) Phase 3 5101 Invasive Disease-Free Survival for using STEEP criteria (Standardized Definitions for Efficacy End Points in adjuvant breast cancer trials) Ribociclib endocrine therapy Endocrine therapy Pre and postmenopausal women and men with HR-positive, HER2-negative EBC, after adequate surgical resection, who are eligible for adjuvant endocrine therapy Read-out Milestone(s) 2023 Publication TBD 70 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#71Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology NIS793 - TGFẞ inhibitor NCT04935359 daNIS-2 (CNIS793B12301) Indication Phase 1L metastatic pancreatic ductal Adenocarcinoma Phase 3 Patients 501 Primary Outcome Measures Arms Intervention Safety run-in part: Percentage of participants with dose limiting toxicities (DLTs) during the first cycle (4 weeks) of treatment Randomized part: Overall survival (OS) Safety run-in part: NIS793+gemcitabine+nab-paclitaxel Randomized portion of the study: Arm 1: NIS793+gemcitabine+nab-paclitaxel Arm 2: placebo+gemcitabine+nab-paclitaxel Patients with Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC), first line treatment Primary: 2024 Target Patients Read-out Milestone(s) Publication NA 71 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#72Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology Piqray® - PI3K-alpha inhibitor NCT04208178 EPIK-B2 (CBYL719G12301) Indication HER2+ adv breast cancer Phase 3 Phase Patients 548 Primary Outcome Measures Arms Intervention Progression-free survival (PFS) Alpelisib + trastuzumab + pertuzumab Trastuzumab + pertuzumab Patients with HER2-positive advanced breast cancer with a PIK3CA mutation Target Patients Read-out Milestone(s) 2025 Publication TBD 72 Investor Relations | Q3 2022 Results Piqray®-PI3K-alpha inhibitor References Abbreviations Other Indication Phase NCT04251533 EPIK-B3 (CBYL719H12301) Triple negative breast cancer Phase 3 Patients 566 Primary Progression-free Survival (PFS) for patients with PIK3CA mutant status Outcome Measures Arms Intervention Target Patients Alpelisib 300 mg + nab-paclitaxel 100 mg/m² Placebo nab-paclitaxel 100 mg/m² Patients with advanced triple negative breast cancer with either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) mutation or Phosphatase and Tensin Homolog Protein (PTEN) loss without PIK3CA mutation Read-out Milestone(s) Publication 2025 TBD NOVARTIS | Reimagining Medicine#73Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology Piqray® - PI3K-alpha inhibitor NCT04729387 EPIK-O (CBYL719K12301) Ovarian Cancer Indication Phase Phase 3 Patients 358 Primary Outcome Measures Arms Intervention Target Patients Progression Free Survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment using RECIST 1.1 criteria Arm 1 Experimental: Alpelisib+olaparib: Alpelisib 200 mg orally once daily and olaparib 200 mg orally twice daily on a continuous dosing schedule Arm 2 Active Comparator: Paclitaxel or PLD. Investigator's choice of one of 2 single agent cytotoxic chemotherapies: Paclitaxel 80 mg/m2 intravenously weekly or Pegylated liposomal Doxorubicin (PLD) 40-50 mg/m2 (physician discretion) intravenously every 28 days. Patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected Read-out Milestone(s) 2023 Publication TBD 73 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#74Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology PluvictoⓇ - Radioligand therapy target PSMA NCT04689828 PSMAfore (CAAA617B12302) References Abbreviations Other PluvictoⓇ - Radioligand therapy target PSMA NCT04720157 PSMAddition (CAAA617C12301) Metastatic hormone sensitive prostate cancer Phase 3 1126 Radiographic Progression Free Survival (rPFS) Indication Metastatic castration-resistant prostate cancer, pre-taxane Indication Phase Phase 3 Phase Patients 450 Patients Primary Radiographic Progression Free Survival (rPFS) Primary Outcome Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) Arm 1: Participants will receive 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT may be used Arm 2: For participants randomized to the ARDT arm, the change of ARDT treatment will be administered per the physician's orders. Best supportive care, including ADT may be used mCRPC patients that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or MHSPC settings Primary Analysis: 2022 Final Analysis: 2025 Publication TBD Measures Arms Intervention Target Patients Arm 1: 177Lu-PSMA-617 Participant will receive 7.4 GBq (+/- 10%) 177Lu- PSMA-617, once every 6 weeks for a planned 6 cycles, in addition to the Standard of Care (SOC); ARDT +ADT is considered as SOC and treatment will be administered per the physician's order Arm 2: For participants randomized to Standard of Care arm, ARDT +ADT is considered as SOC and treatment will be administered per the physician's order Patients with metastatic Hormone Sensitive Prostate Cancer (mHSPC) Read-out Milestone(s) Publication Primary Analysis: 2024 TBD 74 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#75Company overview Financial performance Cardiovascular Financial review 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials Immunology Neuroscience Oncology Promacta® - Thrombopoetin receptor agonist NCT03025698 ESCALATE (CETB115E2201) Refractory or relapsed severe aplastic anemia Indication Phase Phase 2 Patients 51 Primary Outcome Measures Arms PK of eltrombopag at steady state in pediatric patients with SAA References Abbreviations Other Promacta® - Thrombopoetin receptor agonist NCT03988608 (CETB115E2202) Indication Refractory or relapsed severe aplastic anemia Hematologic response rate rate up to 26 weeks of treatment Phase Phase 2 Patients 20 Primary Outcome Measures Arms Intervention Intervention Target Patients Eltrombopag 12.5, 25, 50, 75 mg FCT & 25 mg pFOS Arm A: relapsed/refractory SAA or recurrent AA following IST for SAA: hATG/cyclosporine + eltrombopag or cyclosporine + eltrombopag Arm B: previously untreated SAA: hATG/cyclosporine + eltrombopag Pediatric patients from age 1 <18 years with relapsed/refractory SAA or recurrent AA after IST or previously untreated SAA Primary CSR: 2022 Read-out Milestone(s) Publication Final CSR: 2025 Abstract submitted to 64th ASH Annual Meeting and Exposition. 'Eltrombopag in Pediatric Patients with Previously Untreated or Refractory/Relapsed Severe Aplastic Anemia: The Phase II Escalate Trial' Target Patients Read-out Milestone(s) Eltrombopag 25 mg film-coated tablets Chinese patients with refractory or relapsed severe aplastic anemia Primary CSR: 2021 Interim CSR: 2022 Final CSR:2025 Publication TBD 75 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#76Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology RydaptⓇ - Multi-targeted kinase inhibitor NCT03591510 (CPKC412A2218) Indication Acute myeloid leukemia, pediatrics Phase 2 Phase Patients 20 Primary Outcome Measures Arms Intervention Target Patients Occurrence of dose limiting toxicities Safety and Tolerability Chemotherapy followed by Midostaurin Newly diagnosed pediatric patients with FLT3 mutated acute myeloid leukemia (AML) Read-out Milestone(s) 2026 Publication TBD References Abbreviations Other 76 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#77Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology sabatolimab - TIM3 antagonist sabatolimab - TIM3 antagonist References Abbreviations Other Indication NCT03946670 STIMULUS MDS-1 (CMBG453B12201) Myelodysplastic syndrome Indication Phase Phase 2 Phase NCT04150029 STIMULUS-AML1 (CMBG453C12201) Unfit acute myeloid leukaemia Phase 2 Patients 120 Patients 86 Primary Complete Remission (CR) rate and Progression Free Survival (PFS) Primary Outcome Outcome Measures Measures Arms Intervention Experimental: Sabatolimab (MBG453) + hypomethylating agents Placebo comparator: Placebo + hypomethylating agents Arms Intervention Target Patients Adult subjects with intermediate, high or very high risk Myelodysplastic Syndrome (MDS) as per IPSS-R criteria Target Patients Incidence of dose limiting toxicities (Safety run-in patients only) Percentage of subjects achieving complete remission (CR) Single arm safety and efficacy study of sabatolimab in combination with azacitidine and venetoclax Newly diagnosed adult AML patients who are not suitable for treatment with intensive chemotherapy Read-out Milestone(s) 2022 Read-out Milestone(s) 2023 ClinicalTrial.gov dates for reference: Primary Completion: 29-Apr-2022; Secondary Completion: 10-Aug-2024 Publication TBD Publication 77 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#78Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology sabatolimab - TIM3 antagonist NCT04266301 STIMULUS-MDS2 (CMBG453B12301) Indication Myelodysplastic syndrome Phase Phase 3 Patients 500 Primary Overall survival Outcome Measures Arms Intervention Sabatolimab 800 mg + azacitidine 75 mg/m2 Sabatolimab 800 mg + azacitidine 75 mg/m2 + placebo Patients with intermediate, high or very high risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) Target Patients Read-out Milestone(s) 2024 Publication TBD 78 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#79Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology ScemblixⓇ - BCR-ABL inhibitor NCT04971226 ASC4FIRST (CABL001J12301) Indication Chronic myeloid leukemia, 1st line Phase 3 Major Molecular Response (MMR) at week 48 Phase Patients 402 Primary Outcome Measures Arms Intervention Target Patients Arm 1: asciminib 80 mg QD Arm 2: Investigator selected TKI including one of the below treatments: -Imatinib 400 mg QD - Nilotinib 300 mg BID - Dasatinib 100 mg QD Bosutinib 400 mg QD Patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase Read-out Milestone(s) 2024 Publication TBD 79 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#80Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology TabrectaⓇ Ⓡ- Met inhibitor NCT04427072 (CINC280A2301) Non-small cell lung cancer Indication Phase Phase 3 Patients 90 Primary Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) Progression free survival (PFS) per blinded independent review committee (BIRC) using RECIST v1.1 Arm 1: 400mg of capmatinib tablets administered orally twice daily Arm 2: Docetaxel 75 mg/m2 by intravenous infusion every 21 days Previously Treated Patients With EGFR wt, ALK Negative, Locally Advanced or Metastatic (Stage IIIB/IIIC or IV) NSCLC Harboring MET Exon 14 Skipping Mutation (METAex14). Primary 2022 Final: 2024 Publication TBD 80 Investor Relations | Q3 2022 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#81Company overview Financial review 2022 priorities Appendix Financial performance Innovation: Pipeline overview Innovation: Clinical trials Cardiovascular Immunology Neuroscience Oncology TNO155-SHP2 inhibitor NCT03114319 (CTNO155X2101) Indication Solid tumors (single agent) Phase 1 Phase Patients 255 Primary Outcome Measures Arms Intervention Target Patients Number of participants with adverse events Number of participants with dose limiting toxicities Drug: TNO155 Drug: TNO155 in combination with EGF816 (nazartinib) Adult patients with advanced solid tumors in selected indications Read-out Milestone(s) 2023 Publication TBD References Abbreviations Other 81 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#82Company overview Financial performance Cardiovascular Financial review 2022 priorities Innovation: Pipeline overview Immunology Neuroscience Ophthalmology Global Health Other Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 82 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#83Company overview Financial performance Cardiovascular Financial review 2022 priorities Innovation: Pipeline overview Immunology Neuroscience Ophthalmology Global Health Ophthamology Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 83 Investor Relations | Q3 2022 Results 1 NOVARTIS | Reimagining Medicine#84Company overview Financial performance Cardiovascular Ophthalmology Financial review 2022 priorities Innovation: Pipeline overview Immunology Neuroscience Global Health BeovuⓇ - VEGF Inhibitor NCT04278417 (CRTH258D2301) Indication Diabetic retinopathy Phase Phase 3 Patients 706 Primary Change from Baseline in BCVA Outcome Measures Arms Intervention Target Arm1: RTH258 (brolucizumab) 6 mg/50uL Arm2: Panretinal photocoagulation laser initial treatment followed with additional PRP treatment as needed Patients with proliferative diabetic retinopathy Patients Read-out Milestone(s) 2024 Publication TBD Appendix Innovation: Clinical trials References Abbreviations Oncology Other Biosimilars 84 Investor Relations | Q3 2022 Results 1 NOVARTIS | Reimagining Medicine#85Company overview Financial performance Cardiovascular Ophthalmology Financial review 2022 priorities Innovation: Pipeline overview Immunology Neuroscience Global Health libvatrep - TRPV1 antagonist Indication Phase NCT04630158 SAHARA (CSAF312B12201) Chronic ocular surface pain Phase 2 Patients 150 Primary Change in mean pain severity Visual Analog Scale Outcome Measures Arms Intervention Placebo Comparator: SAF312 Placebo. Randomized to a 1:1:1 topical eye drops, twice daily Experimental: SAF312 dose 1. Randomized to a 1:1:1 topical eye drops, twice daily Experimental: SAF312 dose 2. Randomized to a 1:1:1 topical eye drops, twice daily Subjects with CICP persisting at least for 4 months after refractive surgery and chronicity confirmed during the observational period. Target Patients Read-out Milestone(s) 2023 Publication 2023 85 Investor Relations | Q3 2022 Results Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 1 NOVARTIS | Reimagining Medicine#86Company overview Financial performance Cardiovascular Ophthalmology Financial review 2022 priorities Innovation: Pipeline overview Immunology Neuroscience Global Health UNR844 - Reduction of disulfide bonds NCT04806503 READER (CUNR844A2022) Presbyopia Phase 2B Indication Phase Patients 225 Primary Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) Publication Characterize the dose response relationship among UNR844 doses 0 mg/mL, 5 mg/mL, 13.3 mg/mL, 23 mg/mL and 30 mg/mL dosed twice-daily after Month 3 of dosing. Change from baseline in Binocular distance- corrected near visual acuity at 40 cm at Month 3. 1:1 randomization - UNR844 0 mg/mL, 5 mg/mL, 13.3 mg/mL, 23 mg/mL and 30 mg/mL dosed twice-daily for three months Presbyopic participants aged 45 to 55 years 2022: Primary endpoint- when all patients have completed the 3 months treatment period (Actual) 2023: Final analysis -Study completion (all patients have completed 9 months pots treatment period) H1-2023 86 Investor Relations | Q3 2022 Results Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 1 NOVARTIS | Reimagining Medicine#87Company overview Financial review 2022 priorities Financial performance Innovation: Pipeline overview Cardiovascular Immunology Neuroscience Ophthalmology Global Health Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 87 Investor Relations | Q3 2022 Results 1 NOVARTIS | Reimagining Medicine#88Company overview Financial review 2022 priorities Financial performance Innovation: Pipeline overview Cardiovascular Immunology Neuroscience Ophthalmology Global Health AdakveoⓇ P-selectin inhibitor NCT03474965 SOLACE-Kids (CSEG101B2201) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) Publication Sickle cell disease, pediatrics Phase 2 100 PK/PD and safety of SEG101 at 5 mg/kg. SEG101 (crizanlizumab) at a dose of 5 mg/kg by IV infusion + Hydroxyurea/Hydroxycarbamide Pediatric SCD patients with VOC H2-2021 (pediatric patients ≥12 year old) 2024 (pediatric patients <12 year old) 1. Matthew M. Heeney, David C. Rees, Mariane de Montalembert, Isaac Odame, R. Clark Brown, Yasser Wali, Thu Thuy Nguyen, Du Lam, Raquel Merino Herranz, Julie Kanter; Study Design and Initial Baseline Characteristics in Solace-Kids: Crizanlizumab in Pediatric Patients with Sickle Cell Disease. Blood 2020; 136 (Supplement 1): 22-24. doi: https://doi.org/10.1182/blood-2020-137081 2. Matthew M. Heeney, David C. Rees, Mariane De Montalembert, Isaac Odame, R. Clark Clark Brown, Yasser Wali, Thu Thuy Nguyen, Du Lam, Nadege Pfender, Julie Kanter; Initial Safety and Efficacy Results from the Phase II, Multicenter, Open-Label Solace- Kids Trial of Crizanlizumab in Adolescents with Sickle Cell Disease (SCD). Blood 2021; 138 (Supplement 1): 12. doi: https://doi.org/10.1182/blood-2021-144730 88 Investor Relations | Q3 2022 Results Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 1 NOVARTIS | Reimagining Medicine#89Company overview Financial review 2022 priorities Financial performance Innovation: Pipeline overview Cardiovascular Immunology Neuroscience Ophthalmology Global Health cipargamin-PfATP4 inhibitor NCT04675931 KARISMA (CKAE609B12201) Indication Malaria severe Phase 2 Phase Patients 252 Primary Outcome Measures Arms Intervention Percentage of participants achieving at least 90% reduction in Plasmodium falciparum (P. falciparum) at 12 hours [ Time Frame: Day 1 (12 Hours) ] Arm 1: experimental, IV KAE609 Dose regimen 1 Arm 2: experimental, IV KAE609 Dose regimen 2 Arm 3: experimental, IV KAE609 Dose regimen 3 Arm 4: active comparator, IV Artesunate Arm 5: Coartem, Standard of care Patients with Malaria, severe Target Patients Read-out Milestone(s) 2024 Publication TBD Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 89 Investor Relations | Q3 2022 Results 1 NOVARTIS | Reimagining Medicine#90Company overview Financial review 2022 priorities Financial performance Innovation: Pipeline overview Cardiovascular Immunology Neuroscience Ophthalmology Global Health CoartemⓇ PGH-1 NCT04300309 CALINA (CCOA566B2307) Malaria, uncomplicated (<5kg patients) Phase 3 Indication Phase Patients 44 Primary Outcome Measures Artemether Cmax Arms Intervention Target Patients Experimental: artemether lumefantrine (2.5 mg:30 mg) artemether lumefantrine (2.5 mg:30 mg) bid over 3 days, from 1-4 tablets per dose Infants and Neonates <5 kg body weight with acute uncomplicated plasmodium falciparum malaria Primary outcome measure: 2023 Read-out Milestone(s) Publication TBD Appendix Innovation: Clinical trials References Abbreviations Oncology Other Biosimilars 90 Investor Relations | Q3 2022 Results 1 NOVARTIS | Reimagining Medicine#91Company overview Financial review 2022 priorities Financial performance Innovation: Pipeline overview Cardiovascular Immunology Neuroscience Ophthalmology Global Health ganaplacide - Imidazolopiperazines derivative NCT04546633 KALUMI (CKAF156A2203) Indication Phase Malaria, uncomplicated Phase 2 PCR-corrected and uncorrected Adequate Clinical and Parasitological Response (ACPR) Patients 292 Primary Outcome Measures Arms Intervention KAF156 and LUM-SDF QD (once daily) for 2 days in fasted condition KAF156 and LUM-SDF QD (once daily) for 2 days in fed condition Malaria patients 6 months to < 18 years old Target Patients Read-out Milestone(s) 2023 Publication TBD Appendix Innovation: Clinical trials References Abbreviations Oncology Other Biosimilars 91 Investor Relations | Q3 2022 Results 1 NOVARTIS | Reimagining Medicine#92Company overview Financial performance Cardiovascular Financial review 2022 priorities Innovation: Pipeline overview Immunology Neuroscience Ophthalmology Global Health Biosimilars Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 92 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine#93Company overview Financial review 2022 priorities Financial performance Innovation: Pipeline overview Cardiovascular Immunology Neuroscience Ophthalmology Global Health aflibercept - VEGF inhibitor NCT04864834 Mylight (CSOK583A12301) Ophthalmology indication (as originator) Phase 3 Indication Phase Patients 460 Primary Outcome Measures Arms Intervention Best-corrected visual acuity (BCVA) will be assessed using the ETDRS testing charts at an initial distance of 4 meters. The change from baseline in BCVA in letters is defined as difference between BCVA score between week 8 and baseline Arm 1 Biological: SOK583A1 (40 mg/mL) Arm 2 Biological: Eylea EU (40 mg/mL) Patients with neovascular age-related macular degeneration Target Patients Read-out 2023 Milestone(s) Publication tbd Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 93 Investor Relations | Q3 2022 Results 1 NOVARTIS | Reimagining Medicine#94Company overview Financial performance Financial review Abbreviations 2022 priorities Appendix Innovation: Pipeline overview Innovation: Clinical trials aHUS ALL ALS aBC AD Adj. AIH Advanced breast cancer Atopic Dermatitis Adjuvant Autoimmune hepatitis atypical Hemolytic Uremic Syndrome Acute lymphoblastic leukemia Amyotrophic lateral sclerosis HF-REF HNSCC HS ΙΑ IgAN iMN IPF AMI Acute myocardial infarction JIA AML Acute myeloid leukemia jPSA/ERA aNHL Agressive non-Hodgkin's lymphoma AS H2H Ankylosing spondylitis head-to-head study versus adalimumab LVEF mCRPC BC Breast cancer MDR C3G C3 glomerulopathy MDS CCF CINDU Congestive cardiac failure Chronic inducible urticaria MS NASH CLL CML Chronic lymphocytic leukemia Chronic myeloid leukemia nHCM nr-axSpA Chronic heart failure with reduced ejection fraction Head and neck squamous cell carcinoma Hidradenitis suppurativa Interim analysis IgA nephropathy Membranous nephropathy Idiopathic pulmonary fibrosis Juvenile idiopathic arthritis Juvenile psoriatic arthritis / enthesitis-related arthritis Left ventricular ejection fraction Metastatic castration-resistant prostate cancer Multi-drug resistant Myelodysplastic syndrome Multiple sclerosis Non-alcoholic steatohepatitis Non-obstructive hypertrophic cardiomyopathy Non-radiographic axial spondyloarthritis CRC Colorectal cancer COPD Chronic obstructive pulmonary disease NSCLC PEF Non-small cell lung cancer Preserved ejection fraction COSP Chronic ocular surface pain PedPsO Pediatric psoriasis CRSWNP Severe chronic rhinosinusitis with nasal polyps PNH CSU Chronic spontaneous urticaria PsA CVRR-Lp(a) CVRR-LDLC DME Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a) Secondary prevention of cardiovascular events in patients with elevated levels of LDLC Diabetic macular edema PROS RA rMS DLBCL ESCC FL GCA GVHD HCC HD HFPEF Diffuse large B-cell lymphoma refractory Esophageal squamous-cell carcinoma Follicular lymphoma Giant cell arteritis Graft-versus-host disease Hepatocellular carcinoma Huntington's disease Chronic heart failure with preserved ejection fraction RVO Retinal vein occlusion SAA SLE SpA SPMS TNBC T1DM Type 1 Diabetes mellitus SMA Type 1 SMA Type 2/3 Paroxysmal nocturnal haemoglobinuria Psoriatic arthritis PIK3CA related overgrowth spectrum Rheumatoid arthritis Relapsing multiple sclerosis Severe aplastic anemia Systemic lupus erythematosus Spinal muscular atrophy (IV formulation) Spinal muscular atrophy (IT formulation) Spondyloarthritis Secondary progressive multiple sclerosis Triple negative breast cancer 94 Investor Relations | Q3 2022 Results References Abbreviations U NOVARTIS | Reimagining Medicine#95Company overview Financial review 2022 priorities Appendix References References EntrestoⓇ 1 IQVIA National Prescription Audit as of Sep '22. 2 Eligible patients defined as prevalent HFrEF patients within each market's label. G7: US, CA, JP, DE, FR, IT, UK/ 3 Zhang et al., ESC Heart Failure 2020; 7: 3841 4 Proudfoot et al., Int J Cardiol. 2021; 331:164 5 6 Including, but not limited to, the recent 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure (Heidenreich et al., J Am Coll Cardiol. 2022) Approved indications differ by geography. Examples include "indicated to reduce the risk of cardiovascular death and hospitalization for HF in adult patients with CHF. Benefits are most clearly evident in patients with LVEF below normal." (US) HFrEF (EU) HFrEF and HTN (China and JP) 7 Novartis estimate of patients on treatment across all indications 95 Investor Relations | Q3 2022 Results NOVARTIS | Reimagining Medicine

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare