Q1 2023 Results

Made public by

sourced by PitchSend

11 of 101

Creator

Novartis logo
Novartis

Category

Investor Relations

Published

2023

Slides

Transcriptions

#1Company overview Financial review Conclusions Appendix References Q12023 Results Investor presentation U NOVARTIS | Reimagining Medicine#2Company overview Financial review Conclusions 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 the research collaboration with Bicycle Therapeutics; or regarding potential future sales or earnings of the Group or any of its divisions; or regarding discussions of strategy, priorities, plans, expectations or intentions, including our transforming into a "pure-play" Innovative Medicines business; or regarding the Group's liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our planned spin-off of Sandoz. 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: 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 potential that the benefits and opportunities expected from our planned spin-off of Sandoz may not be realized or may be more difficult or take longer to realize than expected; 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 Bicycle® is a registered trademark of Bicycle Therapeutics Limited. 2 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#3Company overview Financial review Conclusions Appendix References Vas Narasimhan, M.D. Chief Executive Officer Company overview 3 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#4Company overview Financial review Conclusions Appendix References Novartis delivers strong sales growth, robust margin expansion and major innovation milestones; raising FY 2023 guidance Q1 SUMMARY Growth and Productivity Q1, % cc Core margin 38.7% (+360 bps) +18% +15% +8% +7% +8% +3% Sales Core Oplnc Sales Core Oplnc Sales Core Opinc Group IM Sandoz Innovation KisqaliⓇ NATALEE Ph3 met primary endpoint in broad early breast cancer population CosentyxⓇ demonstrated durable efficacy up to 52 weeks in Hidradenitis suppurativa (HS) EntrestoⓇ positive CHMP opinion in pediatric HF RLT platform i) Acquisition of FAP-targeting asset¹ and ii) research collaboration on bicyclic peptides² Operations Millburn and Zaragoza approved for PluvictoⓇ HF-heart failure. FAP fibroblast activation protein. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 35 of Condensed Interim Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. Oplnc operating income. IM - Innovative Medicines division. LMIC low and middle income countries. HIC high income countries. CHMP Committee for Human Medicinal Products. 1. Clovis Oncology. 2. Bicycle Therapeutics. 4 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#5Company overview Financial review Conclusions Appendix References Key 2023 readouts for high-value medicines on track Key assets* with submission enabling readouts in 2023 KisqaliⓇ Ph3 NATALEE trial in adjuvant breast cancer testing broad patient population (anatomical stage II and III¹), with final analysis expected in H2 2023 Primary endpoint met at interim analysis PluvictoⓇ PSMAfore trial in mCRPC (post-ARDT, pre-taxane) positive readout; detailed data presentation planned in H2 2023 FDA regulatory submission planned in H2 2023 Iptacopan APPOINT-PNH trial in treatment-naive patients positive readout; detailed data presentation in 2023 PNH FDA filing planned in H1 2023 APPLAUSE-IgAN Ph3 readout² planned in H2 2023 APPEAR-C3G Ph3 readout planned in H2 2023 *Unprobabilized peak sales of all asset indications in late-stage development: > USD 1bn > USD 2bn > USD 3bn mCRPC metastatic castration resistant prostate cancer. ARDT-androgen receptor directed therapy. 1. Based on AJCC prognostic staging. 2. 9 months analysis potentially supporting US Subpart H filing. 5 Investor Relations | Q1 2023 Results INNOVATION Data at EBMT ✓ NOVARTIS | Reimagining Medicine#6Company overview Financial review Conclusions Appendix References Submission enabling readouts expected to increase in 2024-2025 timeframe Selected key assets* with submission enabling readouts in 2024-2025 Remibrutinib CSU Primary analysis¹ in H2 2023 Final (52 weeks) readout and submission in 2024 ScemblixⓇ 1L CML-CP Readout and submission in 2024 Accelerated submission timeline PluvictoⓇ MHSPC Readout and submission in 2024 OAV-101 SMA IT Readout in 2024; submission in 2025 Pelacarsen CVRR Readout and submission in 2025 lanalumab 1L and 2L ITP readouts in 2025 with submission in 2026 Additional hematology and immunology indications 2026+ Iptacopan Additional readouts/submissions in 2025/2026+ *Unprobabilized peak sales of all asset indications in late-stage development: > USD 1bn > USD 2bn > USD 3bn 1. Double blind treatment period of 24 weeks with primary analysis at 12 weeks. 6 Investor Relations | Q1 2023 Results INNOVATION NOVARTIS | Reimagining Medicine#7Company overview Financial review Conclusions Appendix References Kisqali® NATALEE study met its primary endpoint demonstrating clinically meaningful iDFS benefit in broad eBC population INNOVATION KisqaliⓇ (400mg) plus ET significantly reduced the risk of disease recurrence (vs. standard ET alone) Data to be presented at an upcoming medical meeting 30-60% of people with stage II and III eBC treated with ET alone remain at risk of BC recurrence Consistent benefit in a broad population of stage II and III eBC patients at risk of recurrence, including those with no nodal involvement Worldwide regulatory submissions on track for H2 2023 400mg dose used to reduce dose-dependent AEs given tolerability profile of treatment is critical in early breast cancer eBC - early breast cancer. ET endocrine therapy. iDFS-invasive disease free survival. 7 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#8Company overview Financial review Conclusions Appendix References KisqaliⓇ NATALEE unique in covering a broad population of eBC Kisqali eBC opportunity Multibillion USD1 Incident population (estimated)³ US EU5 Stage II 66k 66k Stage III 15k 24k Stage IV (metastatic) 32k 32k NATALEE population Covers -70% of Stage II, 100% of Stage III ~2-3x patient opportunity vs. monarchE eBC early breast cancer. NATALEE covers broad population in eBC Stage II (132k)3 NO NO NO Unique to NATALEE² Stage III (39k)³ NO N1 INNOVATION Unique to NATALEE Total NATALEE opportunity N2 N1 Total NATALEE opportunity N3 ET endocrine therapy. iDFS invasive disease-free survival. 1. Unprobabilized peak sales. 2. Under stage II: NO, TON1 is excluded; T2N0 only if G3, or G2 with Ki67≥20% or high risk on Oncotype DX/ 3. Estimated incidence US + EU5. Sources: DRG (US) and Kantar (EU5). TNM and grade information based on SEER AJCC 8th Incidence Report. Prosigna / MammaPrint / EndoPredict. 8 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#9Company overview Financial review Conclusions Appendix References INNOVATION Iptacopan APPOINT-PNH data showed clinically meaningful increases in Hb levels for treatment-naive adult patients with PNH APPOINT-PNH: Single-arm Ph3 trial in adult patients with PNH with hemolysis (LDH > 1.5x ULN) and anemia (Hb < 10g/dL) naive to complement inhibitors Iptacopan 200mg BID1 Duration Up to 8 weeks- 24 weeks Time D-58 D1 D168 24 weeks Study period Screening period Core treatment period Treatment extension period D336 EoS Study status Met primary endpoint of proportion of patients achieving a sustained increase in Hb of ≥ 2g/dL, in the absence of transfusions, at 24 weeks Safety profile consistent with previously reported data Data to be presented at EBMT April 26, 2023 Hb hemoglobin. LDH lactate dehydrogenase. ULN upper limit of normal. PNH - paroxysmal nocturnal hemoglobinuria. EBMT - European society for blood and marrow transplantation. 1. BID twice daily. 9 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#10Company overview Financial review Conclusions Appendix References Strengthening radioligand therapy pipeline; advancing multiple assets in clinical development INNOVATION Recent business development in RLT Discovery collaboration with Bicycle Therapeutics ■ BicycleⓇ platform employs constrained cyclic peptides - Provides variety of structural shapes/chemical diversity - May broaden the tractable target space (key differentiator from other peptide platforms) Current RLT pipeline ■ Supplements our existing vector discovery platforms Acquisition of FAP-2286 (Clovis Oncology) ■ Fibroblast Activation Protein (FAP) represents a promising RLT target in PDAC, CRC, BC, NSCLC - Frequently expressed on cancer-associated fibroblasts across cancers FAP-2286, currently developed in Ph1/2 - - Showed first signs of efficacy/favorable safety profile ■ Potential to be first-in-class, transformative RLT Selected compound (indication) Lutathera (1L GEP-NET) Phase 1 Phase 2 Phase 3 Lutathera (Pediatrics + PPGL)1 1 Lutathera (GBM)² Lutathera (ES-SCLC)² Pluvicto (mHSPC) 2 Pluvicto (mCRPC) pre-taxane 225AC-PSMA-617 3 (PCa+bone metastases) 4 NeoB (multi tumor) 5 FAP-22862,3 NSCLC non-small cell lung cancer. GEP-NET - gastroenteropancreatic neuroendocrine tumor. ES-SCLC extensive stage small cell lung metastatic castration resistant prostate cancer. 1. PPGL, pheochromocytomas and paragangliomas, are an exploratory cohort of NETTER-P. 2. Phase 1/2. PDAC - pancreatic ductal adenocarcinoma. CRC colorectal cancer. BC breast cancer. mHSPC metastatic hormone sensitive prostate cancer. mCRPC cancer. 3. Being integrated in the NVS pipeline. 10 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#11Company overview Financial review Conclusions Appendix References Q1 growth driven by strong performance from EntrestoⓇ, PluvictoⓇ, KesimptaⓇ and KisqaliⓇ Q1 sales Entresto sacubitri/valsartan Sales USD million Growth vs. PY USD million 1,399 PLUVICTO™ 211 209 Kesimpta 384 189 (ofatumumab) KISQALI 415 176 ribociclib Ⓒ SCEMBLIX® 76 51 (asciminib) LEQVIO® 64 50 PROMACTA® 547 56 (eltrombopag) Tafinlar. Mekinist. 458 55 d ILARIS 328 43 (canakinumab) istration PIQRAY 116 (alpelisib) tablets 43 JAKAVI ruxolitinib 414 25 Growth vs. PY CC 306 32% nm GROWTH 100% Strong growth (+67% cc); 81% expected to continue 202% nm 15% 18% 19% 61% 13% Constant currencies (cc) is a non-IFRS measure; explanation of non-IFRS measures can be found on page 35 of Condensed Interim Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. nm not meaningful. 11 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#12Company overview Financial review Conclusions Appendix References EntrestoⓇ delivering strong double-digit growth in all geographies GROWTH Entresto Sales evolution USD m, % cc Ex-US US US weekly TRX1 Total prescriptions (000) 110 100 +32% 90 80 1,399 70 28 1,093 60 695 50 551 40 40 30 20 704 542 20 Strong Q1 momentum, outpacing market² US: NBRX +30% vs PY, ~1.3m TRx in Q11 EU: Continued growth in HFrEF China/Japan: Significant contribution from HTN³ Confidence in future growth4 Expect further penetration in HFrEF (2/3 eligible patients still on prior SoC) Robust guideline position 5 (US/EU) CHMP positive opinion for pediatric HF6 China/Japan: Launch momentum in HTN, inclusion in 2023 China HTN guideline as 1L option Q1 2022 10 0 Q1 2023 July 2015 Mar 2023 total prescriptions. HTN TRX NBRX new to brand prescriptions. HFrEF-heart failure with reduced ejection fraction. HF heart failure. hypertension. SOC standard of care. 1. IQVIA National Prescription Audit. 2. CHF market basket includes ACEI, ARB, SGLT2i, Entresto. Data refers to US. 3. 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 CHF and HTN (JP). HTN is not an approved indication in the US. 4. For forecasting purposes, we assume no generic entry in US before 2025. 5. AHA/ACC/HFSA/ESC. 6. If approved, pediatric indication would support extension of the regulatory data protection to November 2026 in EU. 12 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#13Company overview Financial review Conclusions Appendix References CosentyxⓇ ex-US growth offset by US decline. Global FY sales expected broadly in line with PY GROWTH Sales evolution USD m, % cc Ex-US US 1,159 500 -4% 1,076 548 659 528 Q1 2022 Q1 2023 Q1 performance US: Demand growth offset by revenue deductions (incl. PY base impact) Ex-US: Strong growth in core indications China: Outperforming market with double-digit growth post-COVID 2023: Expect FY sales broadly in line with PY (H1 decline and H2 growth) Future growth mainly driven by life cycle management EU: CHMP opinion for HS expected Q2 US: HS/ IV approvals expected H2 Lupus Nephritis and Giant Cell Arthritis Phase 3 trials on track New Phase 3 trials initiated in Polymyalgia Rheumatica and Rotator Cuff Tendinopathy CHMP Committee for Human Medicinal Products. HS-hidradenitis suppurativa. IV - intravenous. 13 Investor Relations | Q1 2023 Results Cosentyx® NOVARTIS | Reimagining Medicine#14Company overview Financial review Conclusions Appendix References GROWTH Cosentyx® HS demonstrated durable efficacy, sustained up to 1 year Cosentyx® HS unmet need Lesions and abscesses in sensitive areas of the body ~97% patients suffer from pain¹ ~95% eligible patients not on biologic² ~50% biologic treated patients lose response³ Cosentyx opportunity ~400k addressable patients in US and EU4 Cosentyx Ph3 data** Durable efficacy sustained to 1 year Patients achieving AN50 (%) 80 70 60 56.2 Placebo SECQ2W Placebo SECQ4W SECQ4W 53.3 SECQ2W 39.7 30 Placebo 0 T 0 2 4 8 12 16 18 20 24 28 32 36 Week 40 44 48 52 Safety consistent with well-established* profile 7,5 Well tolerated Infrequent SAES Candidiasis uncommon³ 70.6 70.5 O 67.6 63.9 >70% with at least a 50% reduction in total abscess & inflammatory nodule count5 ≥70% flare free5 >65% with pain relief Fast and lasting QoL improvement5 Low immunogenicity See page 94 for references 1-8. HS hidradenitis suppurativa. QoL quality of life. SAE - serious adverse event. *Refers to approved indications. **HS indication currently under regulatory review. 14 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#15Company overview Financial review Conclusions Appendix References GROWTH KesimptaⓇ continues strong launch trajectory doubling sales vs. PY Kesimpta Sales evolution USD m, % cc US weekly NBRX1 350 Ex-US US 300 +100% 250 384 89 200 150 195 100 295 172 50 тим 0 Q1 2022 Q1 2023 Sept 2020 Mar 2023 Global sales +100% (cc)² US: Growing faster than market1,2 TRX +89% vs. PY (market +1%) NBRX +60% vs. PY (market -8%) B-cell NBRX share -50% of MS market KesimptaⓇ NBRx share ~14% of MS market Europe: Strong launch momentum³ 65% of population with access to Kesimpta >18k patients treated, thereof >1/3 naive patients Confident in future growth Significant room to grow: only 40% of MS patients on B-Cell therapy in US1,2 Compelling product profile: 1 minute a month dosing from home/anywhere4; 5 year efficacy 5 and safety data 6,7 See page 94 for references 1-7. TRX total prescriptions. NBRX-new to brand prescription. 15 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#16Company overview Financial review Conclusions Appendix References KisqaliⓇ gaining momentum globally, with increasing recognition of its differentiated profile GROWTH Sales evolution USD m, % cc Ex-US US +81% 415 233 239 160 79 US metastatic BC NBRx share1 R3M, % 13% 182 Q1 2022 Q1 2023 Feb 2022 KISQALI 28% Q1 sales USD 415 million, +81% cc US NBRX1 share doubled vs. PY to 28% EU5 1L MBC NBRx share up to 38% (Q4'22) vs. 32% (in Q3'22) Feb 2023 Favorable NCCN2 guidelines positioning Kisqali as only Category 1 treatment for 1L mBC with Al Positive readout of Ph3 NATALEE study in eBC; data to be presented at upcoming congress mBC metastatic breast cancer. NBRX new to brand prescription. R3M rolling 3 months. Q1 R3M. 2. NCCN Guidelines updated as of 27-Jan-2023. eBC - early breast cancer. NCCN national comprehensive cancer network. Al-aromatase inhibitor. 1. Of CDK4/6 mBC market, US 16 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#17Company overview Financial review Conclusions Appendix References LeqvioⓇ adoption expanding as we progress the launch GROWTH LEQVIO® Addressing non-clinical barriers in US Adoption Adoption Facilities having ordered LeqvioⓇ HCPS2 with LeqvioⓇ experience US LeqvioⓇ launch tracking EntrestoⓇ US sales evolution USD m 50 +29% +33% 40 30 EntrestoⓇ 20 LeqvioⓇ 2,200 9,600 10 1,400 1,700 7,200 4,800 0 6 12 18 24 30 30 36 Q3 2022 Q4 2022 Q1 2023 Q3 2022 Q4 2022 Q1 2023 Months since launch Access Adherence Patients covered Patients coming for at or near label³ 76% 2nd dose within <95 days4 75% Global sales evolution USD m 64 Ex-US US 42 34 22 14 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023 HCP healthcare professional. *Leqvio® is administered initially, again at 3 months, and then 1. Either an alternate site of care or a physician practice. 2. Either prescribe LeqvioⓇ to a patient based on service center data, data on file or have ordered through Free Trial Offer program. 3. As of April 10, 2023. 4. Refers to average duration in between doses. Based on IQVIA and data shared by infusion management and ambulatory infusion center companies. once every 6 months. Novartis has obtained global rights to develop, manufacture and commercialize LeqvioⓇ under a license agreement with Alnylam Pharmaceuticals. 17 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#18Company overview Financial review Conclusions Appendix References PluvictoⓇ uptake reflects strong benefit/risk profile and unmet need in post-taxane mCRPC GROWTH Sales evolution Global sales, USD m 80 179 211 10 2 Q1 Q2 Q3 Q4 2022 Q1 2023 Q1 sales USD 211 million (mostly US) Q2 sales expected broadly in line with Q1 200 unique accounts in US currently treating with PluvictoⓇ PSMAfore pre-taxane study (which met its primary endpoint. of rPFS) expected to be presented in H2 2023 FDA submission for PSMAfore including OS data is planned for H2 2023 as aligned with FDA Millburn facility approved to support US launch; Zaragoza approved for EU mCRPC metastatic castration-resistant prostate cancer. rPFS radiographic progression free survival. 18 Investor Relations | Q1 2023 Results OS overall survival. P PLUVICTO™ NOVARTIS | Reimagining Medicine#19Company overview Financial review Conclusions Appendix References Millburn approved for PluvictoⓇ commercial supply in US; Zaragoza approved for EU GROWTH Expected commercial coverage by end 2023 Manufacturing site: Ivrea Millburn Indianapolis Zaragoza US ✓ Approved ✓ Approved FDA filing in preparation EU ✓ Approved ROW ✓ Approved 1 ✓ Approved² ✓ Approved In preparation² In preparation P PLUVICTO™ Millburn to ramp up gradually; expected to contribute meaningfully to supply and sales in Q3 after anticipated approval of additional lines Ivrea will continue to supply the US market in addition to EU Zaragoza also approved to supply EU Targeting capacity of at least 250k doses annually for 2024+3 1. Currently approved for Canada, Switzerland and UK; further ROW submissions ongoing. 2. Canada. 3. Total production across all RLTS. 19 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#20Company overview Financial review Conclusions Appendix References ScemblixⓇ maintains strong launch momentum Sales evolution USD m Ex-US US 52 10 41 31 25 76 15 61 42 37 29 25 Q1 Q2 Q3 Q4 Q1 2022 2023 TKI tyrosine kinase inhibitor. GROWTH OSCEMBLIX® (asciminib) 20 mg. 40 mg tablets Q1 sales USD 76 million; US NBRx share at 32%¹ Sales driven by patients resistant/intolerant to other TKIs Global rollout ongoing with approval in 46 countries; access pathways in 19, negotiations ongoing in 30+ Increasing recognition of efficacy and tolerability benefit: G-BA granted the highest ever rating for a medicine in CML ASC4FIRST (1L registrational study) completed enrollment ahead of plan, readout and filing expected 2024 NBRX-new to brand prescription. G-BA- German national payer (Gemeinsamer Bundesausschuss). 1. IQVIA: US Jan 2023 rolling three months 3L+ new patient start share. 20 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#21Company overview Financial review Conclusions Appendix References Harry Kirsch Chief Financial Officer Financial review and 2023 guidance 21 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#22Company overview Financial review Conclusions Appendix References Strong top and bottom line growth in Q1 Group1 Q1 Change vs. PY USD million 2023 % USD % CC Net Sales 12,953 3 8 Core Operating income 4,413 8 15 Operating income 2,856 0 9 Net income 2,294 3 14 Core EPS (USD) 1.71 17 25 25 EPS (USD) 1.09 9 20 20 Free Cash Flow 2,720 95 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 35 of the Condensed Interim Financial Report. 22 Investor Relations | Q1 2023 Results FINANCIAL PROFILE ✓ NOVARTIS | Reimagining Medicine#23Company overview Financial review Conclusions Appendix References Continuing core margin improvements for Group driven by IM FINANCIAL PROFILE Q1 2023 Net sales change vs. PY1 Core operating income % CC change vs. PY1 % CC Core margin¹ Core margin change vs. PY1 % %pts cc Innovative Medicines 7 18 38.7 3.6 Sandoz Group 8 3 21.1 -1.0 8 15 34.1 2.2 1. Constant currencies (cc), core results are non-IFRS measures. An explanation of non-IFRS measures can be found on page 35 of the Condensed Interim Financial Report. 23 Investor Relations | Q1 2023 Results ✓ NOVARTIS | Reimagining Medicine#24Company overview Financial review Conclusions Appendix References FINANCIAL PROFILE Raising 2023 guidance for Novartis excluding and including Sandoz Expected, barring unforeseen events; growth vs. PY in cc Previous guidance (from low-to-mid) Innovative Medicines (IM) Sales expected to grow mid single digit Core Oplnc expected to grow high single digit to low double digit (from mid-to-high) Novartis ex. Sandoz (IMCorporate) Sales expected to grow mid single digit (from low-to-mid) Core Oplnc expected to grow high single digit to low double digit (from mid-to-high) Novartis incl. Sandoz (IM+ Sandoz + Corporate)1 Sales expected to grow mid single digit Core Oplnc expected to grow high single digit (from low-to-mid) (from mid) Key assumptions: Our guidance assumes that no Sandostatin® LAR generics enter in the US in 2023 ■ We continue to expect that the planned Sandoz spin-off is completed in H2 2023 1. Novartis Group guidance, assuming Sandoz would remain within the Group for the entire FY 2023. 24 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#25Company overview Financial review Conclusions Appendix References Raising Sandoz 2023 top line guidance Expected, barring unforeseen events; growth vs. PY in cc FINANCIAL PROFILE Sales expected to grow mid single digit 2023 Previous guidance (Low-to-mid) Core Oplnc expected to decline low double digit reflecting required stand-up investments to transition Sandoz to a separate company and continued inflationary pressures Sales expected to grow low-to-mid single digit CAGR Mid-term Core Oplnc margin expected to expand to mid 20s, continuously progressing from the low 2023 base driven by continued sales growth and operational efficiencies Key assumptions: We continue to expect that the planned Sandoz spin-off is completed in H2 2023 Note: after completion of planned Sandoz spin-off, Core Oplnc guidance will be expressed in terms of core EBITDA. 25 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#26Company overview Financial review Conclusions Appendix References Sandoz well positioned in a growing market; planned spin-off on track for H2 FINANCIAL PROFILE Q1 performance¹ Sales USD 2.4bn (+8%) Biopharma grew 17%; Retail 6% Strong ex-US sales growth: ■ EU: USD 1.4bn (+16%) ■ ROW: USD 0.6bn (+4%) ■ US: USD 0.4bn (-7%) Core Oplnc (+3%) Continuing to deliver on biosimilar promise Adalimumab HCF approved in US, Europe; launch starting in H2 Denosumab filing accepted (US) Aflibercept Ph3 readout in H2 Announced USD 400 million investment for new biologics plant (Slovenia) On track for planned Sandoz spin-off² in H2 2023 Capital Markets Day - June 8 (NYC) and June 12 (London) Gilbert Ghostine appointed as Sandoz Chairman-Designate Expected tax neutral for Novartis and majority of shareholders HCF high concentration formulation. 1. All growth rates in constant currencies (cc). 26 Investor Relations | Q1 2023 Results 2. Transaction requires Novartis BoD and shareholder approval. NOVARTIS | Reimagining Medicine#27Company overview Financial review Conclusions Appendix References Group Core Oplnc to grow high single digit driven by business momentum and PluvictoⓇ manufacturing capacity expansion FINANCIAL PROFILE 2023 key drivers of core operating income (Group) Vs. PY (cc) Illustrative + In-market growth drivers to continue growing strongly + Recent launches to further accelerate, PluvictoⓇ benefiting from manufacturing capacity expansion + China growth expected to accelerate benefiting from return to normal in H2 + Simplified organizational model to deliver continued SG&A savings + Ongoing productivity programs - - Impact of inflation expected to continue Gx erosion expected to increase due to GilenyaⓇ US and LucentisⓇ EU Stand-up investments to transition Sandoz to a standalone company 27 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#28Company overview Financial review Conclusions Appendix References Expected currency impact for full year 2023 Currency impact vs. PY %pts, assuming late-April exchange rates prevail in 2023 FX impact on Net sales -6 FY I 2022 I FX impact on Core operating income 0 + -1 I I -5 Q1 Q2 FY Actual Simulation 28 Investor Relations | Q1 2023 Results 2023 -8 FY I 2022 I I FINANCIAL PROFILE -3 to -4 -5 -7 Q1 Q2 FY 2023 NOVARTIS | Reimagining Medicine#29Company overview Financial review Conclusions Appendix References Vas Narasimhan, M.D. Chief Executive Officer 29 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#30Company overview Financial review Conclusions Appendix References Conclusions Strong start to 2023: Growth particularly driven by EntrestoⓇ, KisqaliⓇ and KesimptaⓇ Launches: PluvictoⓇ and ScemblixⓇ continue strong trajectory, LeqvioⓇ progresses steadily Confidence in near- to mid-term growth: NATALEE Phase 3 positive readout, upcoming iptacopan data, and PluvictoⓇ in earlier lines of therapy Raising guidance: Strong start and confidence in growth drivers allow to raise FY 2023 guidance. 30 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#31Company overview Innovation: Pipeline overview Financial review Financial performance Appendix Conclusions Appendix Innovation: Clinical trials References Abbreviations 31 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#32Company overview Innovation: Pipeline overview Financial review Financial performance 2023 expected key events Regulatory Cosentyx® HS decisions Cosentyx® 2ml Al Cosentyx® IV Leqvio® Hypercholesterolemia Submissions Iptacopan PNH (US/EU/JP) KisqaliⓇ HR+/HER2- BC (adj) PluvictoⓇ mCRPC, pre-taxane (US) Readouts KisqaliⓇ HR+/HER2- BC (adj) Iptacopan IgAN Ph3 Iptacopan C3G Ph3 Ph3 starts Iptacopan in IC-MPGN LeqvioⓇ CVRR primary prevention lanalumab in immune thrombocytopenia lanalumab in systemic lupus erythematosus Conclusions Appendix Innovation: Clinical trials References Abbreviations H1 2023 EU H2 2023 US Status update - as of end Q1 US US JP, China US/EU JP US Filing expected in H2 US NATALEE Ph3 FIR Primary endpoint met at interim analysis APPLAUSE-IgAN Ph3 APPEAR-C3G Ph3 Ph3 Ph3 Ph3 Ph3 VICTORION-1P initiated 1L (VAYHIT1) and 2L (VAYHIT2) initiated SIRIUS-SLE 1 and 2 initiated HS hidradenitis suppurativa. C3G PNH - paroxysmal nocturnal hemoglobinuria. complement 3 Glomerulopathy. mCRPC metastatic castration-resistant prostate cancer. FIR - first interpretable results. IgAN - immunoglobulin A nephropathy. IC-MPGN - immune complex membranoproliferative glomerulonephritis. 32 Investor Relations | Q1 2023 Results INNOVATION U NOVARTIS | Reimagining Medicine#33Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Our pipeline projects at a glance Innovative medicines Solid Tumors Hematology Immunology Neuroscience Cardiovascular Others Ophthalmology Respiratory & Allergy Global Health Biosimilars¹ Appendix Innovation: Clinical trials References Abbreviations Phase 1/2 Phase 3 Registration Total 81 46 7 134 15 15 2 32 18 8 0 26 20 10 4 34 5 5 0 10 17 6743 62 1 13 0 19 1 0 5 0 0 3 10 1 0 11 n/a 2 0 2 Total 81 48 7 136 1. Selected disclosed, internal projects. Biosimilar pre-Phase 3 are not disclosed. 33 Investor Relations | Q1 2023 Results INNOVATION 1 NOVARTIS | Reimagining Medicine#34Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials References Abbreviations Continuing refinement of R&D portfolio to prioritize high-value transformative medicines -10% Total projects in clinical development decreased by ~10% in Q1 2023 as part of comprehensive portfolio review Prioritization based on 34 Investor Relations | Q1 2023 Results strategic fit (within 5 core TAs) commercial potential 136 Current clinical- stage projects in Novartis pipeline asset value competitive landscape INNOVATION Focused portfolio allows ▪ greater resource allocation to priority projects ■ earlier expansion for high value assets NOVARTIS | Reimagining Medicine#35Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Novartis pipeline in Phase 1 Solid tumors Code AAA603 Name 177Lu-NeoB Mechanism Radioligand therapy target GRPR Radioligand therapy target PSMA HIF2A inhibitor Indication(s) Multiple solid tumors Metastatic castration-resistant prostate cancer Renal cell carcinoma AAA817 225 AC-PSMA-617 DFF332 DFF332 IAG933 IAG933 KAZ954 KAZ954 KFA115 KFA115 MGY825 MGY825 NIR178 NIR178 NZV930 NZV930, spartalizumab, NIR178 Immunology Mesothelioma Novel immunomodulatory Agent Ad2AR inhibitor CD73 antagonist Solid tumors Solid tumors NSCLC Cancers Solid tumors Code Name Mechanism MHV370 NG1226 MHV370 NG1226 Neuroscience Code NIO752 Indication(s) Systemic lupus erythematosus Tendinopathy Name NIO752 Mechanism Indication(s) Tau antagonist Alzheimer's disease 35 Investor Relations | Q1 2023 Results Progressive supranuclear palsy Appendix Innovation: Clinical trials Hematology Code Name HDM201 HDM201 (combos) Mechanism MDM2 inhibitor JBH492 JBH492 MBG453 sabatolimab MIK665 MIK665 TIM3 antagonist MCL1 inhibitor PIT565 PIT565 VAY736 ianalumab + ibrutinib BAFF-R inhibitor VOB560 YTB323 VOB560 rapcabtagene autoleucel CD19 CAR-T Cardiovascular Code XXB750 Name XXB750 Mechanism NPR1 agonist Others Code Name Global Health EDI048 EDI048 EYU688 EYU688 KAF156 INE963 ganaplacide INE963 Ophthalmology MHU650 MHU650 Mechanism References Abbreviations INNOVATION 20 lead indications Lead indication Indication(s) Hematological malignancy Hematological malignancy Low risk myelodysplastic syndrome Hematological malignancies B-cell malignancies Hematological malignancy (combo) Diffuse large B-cell lymphoma Cancers Adult ALL Indication(s) Cardiovascular diseases Indication(s) CpPI(4)K inhibitor NS4B inhibitor Non-artemisinin plasmodium falciparum inhibitor Cryptosporidiosis Dengue Malaria prophylaxis Malaria, uncomplicated Diabetic eye diseases NOVARTIS | Reimagining Medicine#36Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials References Abbreviations INNOVATION Novartis pipeline in Phase 2 Solid Tumors Code AAA601 Hematology Name 23 lead indications Mechanism BCR-ABL inhibitor Name Mechanism Indication(s) Code Lutathera® Radioligand therapy target SSTR GEPNET, pediatrics: ABL001 1L ES-SCLC INC424 Scemblix® Jakavi® JAK1/2 inhibitor Glioblastoma JDQ443 JDQ443 KRAS inhibitor NSCLC and CRC (mono and/or combo) LNP023 iptacopan CFB inhibitor NIS793 niseovkitug TGFB inhibitor 1L metastatic colorectal cancer MBG453 sabatolimab TNO155 TNO155 SHP2 inhibitor Solid tumors PHE885 PHE885 PKC412 RydaptⓇ YTB323 rapcabtagene autoleucel Cardiovascular Code Name TIM3 antagonist BCMA cell therapy Multi-targeted kinase inhibitor CD19 CAR-T Indication(s) Chronic myeloid leukemia, 2L, pediatrics Acute GVHD, pediatrics Chronic GVHD, pediatrics Immune thrombocytopenia Unfit acute myeloid leukemia Acute myeloid leukemia, maintenance 4L multiple myeloma Acute myeloid leukemia, pediatrics 1L high-risk large B-cell lymphoma Immunology Code Name CFZ533 iscalimab Mechanism CD40 inhibitor CMK389 CMK389 IL-18 inhibitor DFV890 DFV890 LNA043 LNA043 NLRP3 inhibitor ANGPTL3 agonist LOU064 remibrutinib BTK inhibitor LRX712 LRX712 MAS825 MAS825 Indication(s) Sjögren's Hidradenitis suppurativa Atopic dermatitis Knee osteoarthritis Familial cold auto-inflammatory syndrome Knee osteoarthritis Osteoarthritis (combos) Food allergy Hidradenitis suppurativa Sjögren's Osteoarthritis NLRC4-GOF indications Hidradenitis suppurativa CFZ533 iscalimab LNP023 iptacopan MBL949 MBL949 ATP modulator TIN816 TIN816 XXB750 XXB750 Others Code Name Global Health KAE609 cipargamin Mechanism CD40 inhibitor CFB inhibitor NPR1 agonist Indication(s) Lupus nephritis Lupus nephritis Obesity related diseases Acute kidney injury Hypertension Mechanism Lead indication Indication(s) MHV370 MHV370 QUC398 QUC398 VAY736 YTB323 ianalumab rapcabtagene autoleucel Neuroscience Code Name ADAMTS5 inhibitor BAFF-R inhibitor CD19 CAR-T Sjögren's Mixed connective tissue disease Osteoarthritis Autoimmune hepatitis Lupus Nephritis Mechanism Indication(s) KLU156 LXE408 Ganaplacide + lumefantrine LXE408 QMF149 Atectura® SEG101 AdakveoⓇ Respiratory & Allergy CMK389 CMK389 LTP001 LTP001 Ophthalmology LNP023 iptacopan SAF312 Libvatrep Malaria, uncomplicated PfATP4 inhibitor Malaria, severe Malaria, uncomplicated Non-artemisinin plasmodium falciparum inhibitor Proteasome inhibitor Combo P-selectin inhibitor IL-18 inhibitor SMURF1 inhibitor CFB inhibitor Gene therapy - Complement factor I modulation TRPV1 antagonist Visceral leishmaniasis Asthma, pediatrics Sickle cell disease, pediatrics Pulmonary sarcoidosis Pulmonary arterial hypertension Idiopathic pulmonary fibrosis iAMD Geographic atrophy Chronic ocular surface pain BLZ945 sotuletinib DLX3131 minzasolmin CSF-1R inhibitor Amyotrophic lateral sclerosis Alpha-synuclein Inhibitor Parkinson's disease MIJ821 onfasprodil NR2B negative allosteric modulator Major depressive disorder with acute suicidal ideation or behavior PPY9882 PPY988 1. DLX313 is the Novartis compound code for UCB0599. 2. Gyroscope acquisition. 36 Investor Relations | Q1 2023 Results U NOVARTIS | Reimagining Medicine#37Company overview Innovation: Pipeline overview Financial review Financial performance Novartis pipeline in Phase 3 Solid Tumors Code AAA617 Conclusions Appendix Innovation: Clinical trials Hematology References Abbreviations INNOVATION 8 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 hemoglobinuria Atypical hemolytic uraemic syndrome Myelodysplastic syndrome 1L Immune Thrombocytopenia 2L Immune Thrombocytopenia warm Autoimmune Hemolytic Anemia Radioligand therapy target SSTR Gastroenteropancreatic neuroendocrine tumors, 1st line in G2/3 tumors (GEP-NET 1L G3) Name Mechanism Indication(s) Pluvicto™ Radioligand therapy target PSMA mCRPC, pre-taxane Metastatic hormone sensitive prostate cancer (mHSPC) AAA6011 LutatheraⓇ BYL719 JDQ443 LEE011 NIS793 Piqray® JDQ443 Kisqali® niseovkitug PI3Ka inhibitor KRAS inhibitor TGFB1 inhibitor VDT482 tislelizumab PD1 inhibitor CDK4/6 Inhibitor Ovarian cancer 2/3L Non-small cell lung cancer HR+/HER2- BC (adj) Code Name ABL001 ETB115 ScemblixⓇ PromactaⓇ LNP023 iptacopan MBG453 VAY736 sabatolimab ianalumab TIM3 antagonist BAFF-R inhibitor Adj/Neo adj. NSCLC 1L Gastric cancer 1L Metastatic pancreatic ductal adenocarcinoma 1L Nasopharyngeal Carcinoma 1L ESCC Immunology Code Name AIN457 IGE025 LOU064 Cosentyx® XolairⓇ remibrutinib QGE031 ligelizumab VAY736 ianalumab Name Mechanism IL17A inhibitor IgE inhibitor BTK inhibitor IgE inhibitor BAFF-R inhibitor Mechanism CGRPR antagonist S1P1,5 receptor modulator 1L Hepatocellular Carcinoma 1L Urothelial Cell Carcinoma Indication(s) Lupus Nephritis Giant cell arteritis Polymyalgia rheumatica Rotator cuff tendinopathy Food allergy Chronic spontaneous urticaria Food allergy Sjögren's Lupus Nephritis Systemic lupus erythematosus Neuroscience Code AMG334 AimovigⓇ BAF312 MayzentⓇ LOU064 remibrutinib OAV101 AVXS-101 OMB157 Kesimpta® BTK inhibitor Indication(s) Migraine, pediatrics Multiple sclerosis, pediatrics Multiple sclerosis SMN1 gene replacement therapy SMA IT administration CD20 Antagonist Multiple sclerosis, pediatrics Localized ESCC 1L Small Cell Lung Cancer Cardiovascular Code Name KJX839 Leqvio® Mechanism siRNA (regulation of LDL-C) Indication(s) CVRR-LDLC Primary prevention Hyperlipidemia, pediatrics IgA nephropathy C3 glomerulopathy Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a) (CVRR-Lp(a)) LNP023 iptacopan CFB inhibitor TQJ230 pelacarsen ASO targeting Lp(a) Others Code Global Health COA566 Coartem® Ophthalmology RTH258 BeovuⓇ Biosimilars Name Mechanism Indication(s) PGH-1 (artemisinin combination Malaria, uncomplicated (<5kg patients) therapy) VEGF inhibitor Code Name GP2411 denosumab SOK583 aflibercept Mechanism anti RANKL mAb VEGF inhibitor Diabetic retinopathy Indication(s) Osteoporosis (same as originator) Ophthalmology indication (as originator) 1. 177 Lu-dotatate in US. 37 Investor Relations | Q1 2023 Results U NOVARTIS | Reimagining Medicine#38Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Novartis pipeline in registration Solid Tumors Code Name Mechanism Indication(s) VDT482 tislelizumab PD1 inhibitor 2L ESCC Non-small cell lung cancer Immunology Code Name Mechanism AIN457 CosentyxⓇ IL17A inhibitor IGE025 XolairⓇ IgE inhibitor 1. Approved in US. Indication(s) Hidradenitis suppurativa Psoriatic arthritis (IV formulation) Axial SpA (IV formulation) Auto-injector Appendix Innovation: Clinical trials Cardiovascular Code LCZ696 Name Entresto® Mechanism Angiotensin receptor/neprilysin inhibitor References Abbreviations INNOVATION 1 lead indication Lead indication Indication(s) Chronic heart failure, pediatrics1 38 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#39Supplementary Lead Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Novartis submission schedule New Molecular Entities: Lead and supplementary indications 2023 iptacopan LNP023 PNH JDQ443 2024 JDQ443 2/3L NSCLC (mono) remibrutinib LOU064 CSU sabatolimab MBG453 HR-MDS Appendix Innovation: Clinical trials References Abbreviations INNOVATION Cardiovascular Immunology Neuroscience Solid tumors Hematology Non-core TA project 2025 Niseovkitug NIS793 1L Pancreatic cancer pelacarsen TQJ230 CVRR-Lp(a) 凹 177Lu-NeoB AAA603 Multiple Solid Tumors ianalumab VAY736 2L Immune Thrombocytopenia iscalimab CFZ533 Sjögren's syndrome ligelizumab QGE031 Food allergy LNA043 Knee osteoarthritis cipargamin KAE609 Malaria severe ganaplacide/lumefantrine KLU156 Malaria uncomplicated libvatrep SAF312 COSP ≥2026 MIJ821 Acute depression rapcabtagene autoleucel YTB323 High-risk large B-cell lymphoma TNO155 Solid tumors XXB750 Hypertension LXE408 Visceral leishmaniasis PPY9881 Geographic atrophy PluvictoⓇ AAA617 mCRPC, Pre-taxane tislelizumab VDT482 1L Gastric Cancer tislelizumab VDT482 1L ESCC tislelizumab VDT482 1L Hepatocellular Carcinoma tislelizumab VDT482 1L Nasopharyngeal cancer W iptacopan LNP023 C3G iptacopan LNP023 IgAN PluvictoⓇ AAA617 mHSPC tislelizumab VDT482 1L Small Cell Lung Cancer tislelizumab VDT482 Localized ESCC ianalumab VAY736 1L Immune Thrombocytopenia ianalumab VAY736 WAIHA ianalumab VAY736 АІН ianalumab VAY736 Sjögren's syndrome cipargamin KAE609 Malaria uncomplicated Y до ianalumab VAY736 Lupus Nephritis ianalumab VAY736 SLE iptacopan LNP023 aHUS JDQ443 JDQ443 NSCLC (combo) rapcabtagene autoleucel YTB323 Lupus Nephritis remibrutinib LOU064 Multiple sclerosis remibrutinib LOU064 Sjögren's syndrome sabatolimab MBG453 Unfit AML tislelizumab VDT482 Adj/Neo adj NSCLC tislelizumab VDT482 1L Urothelial Cell Carcinoma 1. Gyroscope acquisition. 39 Investor Relations | Q1 2023 Results W W NOVARTIS | Reimagining Medicine#40Existing brands Company overview Innovation: Pipeline overview Financial review Financial performance Novartis submission schedule Supplementary indications for existing brands Conclusions Appendix Innovation: Clinical trials References Abbreviations INNOVATION Cardiovascular Immunology Neuroscience Solid tumors Hematology Non-core TA project KisqaliⓇ 2023 ribociclib, LEE011 HR+/HER2- BC (adj) LutatheraⓇ 177 Lu-oxodotreotide GEP-NET 1L G3 XolairⓇ omalizumab, IGE025 Food allergy PiqrayⓇ alpelisib, BYL719 Ovarian cancer denosumab BioS anti RANKL mAb GP2411 JakaviⓇ 2024 ruxolitinib, INC424 Pediatrics Acute GVHD. JakaviⓇ ruxolitinib, INC424 Pediatrics Chronic GVHD ScemblixⓇ ABL001 CML 1L Adakveo SEG101 Sickle cell disease, pediatrics aflibercept SOK583 BioS Neovascular age-related macular degeneration 2025 CosentyxⓇ secukinumab, AIN457 GCA LeqvioⓇ KJX839 Ped Hyperlipidemia ZolgensmaⓇ AVXS-101 OAV101 SMA IT BeovuⓇ brolucizumab, RTH258 Diabetic retinopathy PromactaⓇ eltrombopag, ETB115 Radiation sickness syndrome Coartem® artemether + lumefantrine, COA566 Malaria uncompl., formula for <5kg ty 1. 177 Lu-dotatate in US. 2. Kesimpta and Mayzent: Pediatric study in multiple sclerosis run in conjunction (NEOS). 40 Investor Relations | Q1 2023 Results AimovigⓇ erenumab, AMG334 Pediatric Migraine CosentyxⓇ secukinumab, AIN457 Lupus Nephritis CosentyxⓇ secukinumab, AIN457 Tendinopathy CosentyxⓇ secukinumab, AIN457 Polymyalgia rheumatica KesimptaⓇ2 ofatumumab Multiple sclerosis, pediatrics LeqvioⓇ KJX839 CVRR-LDLC ≥2026 LeqvioⓇ KJX839 Primary prevention MayzentⓇ2 siponimod, BAF312 Multiple sclerosis, pediatrics ty RydaptⓇ midostaurin, PKC412 Acute myeloid leukemia, pediatrics ScemblixⓇ ABL001 CML, 2L, pediatrics AtecturaⓇ indacaterol + mometasone, QMF149 Asthma, pediatrics NOVARTIS | Reimagining Medicine O#41Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials References Abbreviations GROWTH ZolgensmaⓇ sales declined mainly due to pricing dynamics Maintaining leading share in US in <2 years¹; new data demonstrates durability of effect up to 7.5 years 2,3 Sales evolution USD m, % cc zolgensma® Ex-US US 363 -14% 309 250 200 Q1 sales dynamics driven by one-time reimbursement events in PY and ongoing pricing mix dynamics Treatment mainly in incident patients; maintaining >90% share in US1 Continued geographic expansion2 and access expansion to label OAV101 IT development on track (Ph 3 STEER and STRENGTH trials) Sustained durability up to 7.5 years (data at MDA)³: 25/25 children treated prior to SMA symptom onset achieved walking alone 4,5 113 Q1 2022 See page 94 for references 1-5. 109 Q1 2023 SMA spinal muscular atrophy. IT intrathecal. MDA-muscular dystrophy association. 41 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#42Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials FY 2023 guidance on other financial KPIs Barring unforeseen events; (in cc) Group | Full year guidance Core Net Financial Result Expenses expected to decrease by around 0.1bn vs. 2022 (revised from broadly in line vs. 2022) Core Tax Rate Expected to be broadly in line vs. 2022 42 Investor Relations | Q1 2023 Results References Abbreviations FINANCIAL PROFILE NOVARTIS | Reimagining Medicine#43Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials Net debt increased by USD 7.9bn mainly due to dividends and share buybacks, partially offset by FCF USDbn -7.2 -7.3 -2.7 Dec 31, 2022 Dividends Treasury share transactions, net 43 Investor Relations | Q1 2023 Results -7.9 -0.1 M&A/Intangible assets transactions, net -0.5 References Abbreviations FINANCIAL PROFILE -15.1 2.7 Free Cash Flow Others Mar 31, 2023 NOVARTIS | Reimagining Medicine#44Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Conclusions 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 44 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#45Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Conclusions Cardiovascular Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 45 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#46Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology iptacopan - CFB inhibitor NCT04578834 APPLAUSE-IgAN (CLNP023A2301) Indication IgA nephropathy Phase 3 Appendix Innovation: Clinical trials Neuroscience Oncology Phase Patients 450 Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Publication Ratio to baseline in urine protein to creatinine ratio (sampled from 24h urine collection) at 9 months 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 46 Investor Relations | Q1 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#47Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology iptacopan - CFB inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology iptacopan - CFB inhibitor References Abbreviations Other NCT03955445 (CLNP023B12001B) NCT04817618 APPEAR-C3G (CLNP023B12301) C3 glomerulopathy Phase 3 Indication C3 glomerulopathy (C3G) Indication Phase Phase 2 Phase Patients 27 patients from ongoing Ph2 (sample size from Ph3 pending HA discussions Q1 2021), total patients for this study will increase Patients 68 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 Log-transformed ratio to baseline in UPCR (sampled from a 24 hour urine collection) Experimental: iptacopan 200mg b.i.d. Patients with native C3G Arms Intervention Placebo Comparator: Placebo to iptacopan 200mg b.i.d. Target Patients Readout Milestone(s) 2025 Readout Milestone(s) Publication 2023 TBD Publication Wong et al 2021 Nephrology, Dialysis and Transplantation Vol. 36, Suppl. 1: eGFR trajectory 47 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#48Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology LeqvioⓇ - siRNA (regulation of LDL-C) Appendix Innovation: Clinical trials Neuroscience Oncology References Leqvio® - siRNA (regulation of LDL-C) Abbreviations Other NCT03705234 ORION-4 (CKJX839B12301) NCT03814187 ORION-8 (CKJX839A12305B) Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH) and Homozygous Familial Hypercholesterolemia (HoFH) Phase 3 Indication Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH) Indication Phase Phase 3 Patients 15000 Primary Outcome A composite of major adverse cardiovascular events, defined as: Coronary heart disease (CHD) death; Measures Arms Intervention Target Patients Myocardial infarction; 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 2026 Proportion of subjects achieving prespecified low density lipoprotein cholesterol (LDL-C) targets at end of study Phase Patients 3275 Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Publication 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) 2023 A pooled safety analysis of inclisiran in 3576 patients with approximately 10,000 person-years of exposure from seven trials; oral presentation; ACC 2-4 Mar-2023 ORION-8 Primary data publication in 2023 Readout Milestone(s) Publication TBD 48 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#49Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology LeqvioⓇ - siRNA (regulation of LDL-C) NCT04652726 ORION-16 (CKJX839C12301) Appendix Innovation: Clinical trials Neuroscience Oncology References Leqvio® - siRNA (regulation of LDL-C) NCT04659863 ORION-13 (CKJX839C12302) Hyperlipidemia, pediatrics Indication Hyperlipidemia, pediatrics Indication Phase Phase 3 Phase Phase 3 Patients 141 Patients 13 Primary Outcome Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 330 Measures Primary Outcome Measures Arms Intervention Group 1: Inclisiran sodium 300mg on Days 1, 90, 270, placebo on Day 360, inclisiran sodium 300mg on Days 450 and 630 Arms 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) Readout Milestone(s) 2025 Abbreviations Other Target Patients Readout Milestone(s) 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 (O-16/-13) in Eur. J. Prev. Cardiol. Vol. 29, Feb. 2022 (actual) Presentation at EAS May-2022 on O-13/-16 study design (actual) Publication Design publication (O-16/-13) in Eur. J. Prev. Cardiol. Vol. 29, Feb. 2022 (actual) Publication Presentation at EAS May-2022 on O-13/-16 study design (actual) 49 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#50Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology LeqvioⓇ - siRNA (regulation of LDL-C) NCT05030428 VICTORION-2P (CKJX839B12302) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Appendix Innovation: Clinical trials Neuroscience Oncology References Leqvio® - siRNA (regulation of LDL-C) NCT05739383 VICTORION-1P (CKJX839D12302) CVRR (Primary prevention) Phase 3 Secondary prevention of cardiovascular events in patients with elevated levels of LDL-C Indication Phase Phase 3 Patients 14000 15000 1. Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events) Primary Outcome Measures Arm 1: Experimental Inclisiran sodium, Subcutaneous injection Arm 2: Placebo Comparator, Placebo Subcutaneous injection Arms Intervention Participants with established cardiovascular disease (CVD) Readout 2027 Milestone(s) Publication TBD 50 Investor Relations | Q1 2023 Results Target Patients Abbreviations Other Time to the first occurrence of 4P-MACE 4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization Arm 1 Experimental: Inclisiran Sodium 300mg, subcutaneous injection in pre-filled syringe Arm 2 Placebo High-risk primary prevention patients Readout Milestone(s) Publication 2029 TBD NOVARTIS | Reimagining Medicine#51Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology pelacarsen - Antisense oligonucleotide (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 Readout Milestone(s) Publication TBD 51 Investor Relations | Q1 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#52Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology XXB750 - NPR1 agonist NCT05562934 (CXXB750B12201) Conclusions Indication Hypertension Phase Phase 2b Patients 170 Primary Outcome Measures Change from baseline in mean 24hr ambulatory systolic blood pressure at week 12 Arms Intervention Arm 1 experimental: Dose 1 Arm 2 experimental: Dose 2 Arm 3 experimental: Dose 3 Arm 4 experimental: Dose 4 Arm 5 placebo comparator Resistant Hypertension Patients Target Patients Readout Milestone(s) 2024 Publication TBD Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 52 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#53Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Immunology Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 53 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#54Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Cosentyx® - IL-17A inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology 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) Readout Milestone(s) 2025 Publication TBD Target Patients Experimental: Secukinumab 300 mg Placebo Comparator: Placebo Patients with Giant Cell Arteritis (GCA) Primary 2025 Final 2026 Readout Milestone(s) Publication TBD Arms Intervention 54 Investor Relations | Q1 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#55Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Cosentyx® - IL-17A inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology Cosentyx® - IL-17A inhibitor References Abbreviations Other NCT05722522 (CAIN457012301) Rotator cuff tendinopathy Indication Phase Phase 3 Patients 234 Primary Outcome Measures Arms Intervention Change from BSL in in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) score [ Time Frame: At Week 16 ]: - Improving physical shoulder symptoms in participants with moderate to severe RCT at Week 16 Arm 1: Secukinumab 2 X 150 mg / 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio Arm 2: Placebo 2X 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio NCT05758415 (CAIN457012302) Rotator cuff tendinopathy Indication Phase Phase 3 Patients 234 Primary Outcome Measures Arms Intervention Change from BSL in in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) score [ Time Frame: At Week 16]: Change in physical shoulder symptoms in participants with moderate to severe RCT at Week 16 Arm 1 experimental: Secukinumab 2 X 150 mg / 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio Arm 2 placebo: 2 X 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio Patients with moderate-severe Rotator Cuff Tendinopathy Target Patients Patients with moderate-severe Rotator Cuff Tendinopathy Readout Milestone(s) 2025 Publication TBD 55 Investor Relations | Q1 2023 Results Target Patients Readout Milestone(s) 2025 Publication TBD NOVARTIS | Reimagining Medicine#56Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology Cosentyx® - IL-17A inhibitor Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology Indication NCT05767034 REPLENISH (CAIN457C22301) Polymyalgia rheumatica Phase Phase 3 Patients 360 Primary Proportion of participants achieving sustained remission Outcome Measures Arms Intervention Arm 1 Experimental: Secukinumab 300 mg, randomized in 1:1:1 ratio every weeks 4 Arm 2 Experimental: Secukinumab 150 mg, randomized in 1:1:1 ratio every 4 weeks Arm 3 Placebo: randomized in 1:1:1 ratio every 4 weeks Adult patients with PMR who have recently relapsed Target Patients Readout Milestone(s) 2025 Publication TBD References Abbreviations Other 56 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#57Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology ianalumab - BAFF-R inhibitor NCT03217422 AMBER (CVAY736B2201) Indication Autoimmune hepatitis Alanine aminotransferase (ALT) normalization Phase Phase 2 Patients 65 Primary 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 Readout 2024 Milestone(s) Publication TBD 57 Investor Relations | Q1 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology 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: Experiemental - ianalumab s.c. q12w in addition to SoC Arm 3: Placebo comparator - Placebo s.c. q4w in addition to SoC Patients with active Lupus Nephritis Target Patients Readout Milestone(s) Primary 2027 Publication TBD NOVARTIS | Reimagining Medicine#58Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology ianalumab - BAFF-R inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology ianalumab - BAFF-R inhibitor References Abbreviations Other Indication NCT05349214 NEPTUNUS-2 (CVAY736A2302) Sjögren's syndrome Indication NCT05350072 NEPTUNUS-1 (CVAY736A2301) Sjögren's syndrome Phase Phase 3 Phase Phase 3 Patients 489 Patients 285 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 Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Arm 1: Experimental - ianalumab Intervention Arm 2: Placebo comparator Target Patients Patients with active Sjogren's syndrome Readout Milestone(s) Primary 2026 Publication TBD Readout Milestone(s) Primary 2026 Publication TBD 58 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#59Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology ianalumab - BAFF-R inhibitor Conclusions NCT05639114 SIRIUS-SLE 1 (CVAY736F12301) Systemic lupus erythematosus Indication Phase Phase 3 Patients 406 Primary Outcome Measures Arms Intervention Proportion of participants on monthly ianalumab achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) [ Time Frame: Week 60 ] Experimental: lanalumab s.c. monthly Experimental: lanalumab s.c. quarterly Placebo Comparator: Placebo s.c. monthly Target Patients Patients with active systemic lupus erythematosus (SLE) Readout Milestone(s) 2027 Publication TBD 59 Investor Relations | Q1 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology ianalumab - BAFF-R inhibitor NCT05624749 SIRIUS-SLE 2 (CVAY736F12302) References Abbreviations Other Indication Systemic lupus erythematosus Phase Phase 3 Patients 280 Primary Outcome Measures Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) [ Time Frame: Week 60 ] Arms Experimental: ianalumab s.c. monthly Intervention Placebo Comparator: placebo s.c. monthly Target Patients Patients with active systemic lupus erythematosus (SLE) Readout Milestone(s) 2027 Publication TBD NOVARTIS | Reimagining Medicine#60Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology ligelizumab-IgE Inhibitor Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology Indication Phase NCT04984876 (CQGE031G12301) Food allergy Phase 3 Patients 486 Primary Outcome Measures Arms Intervention 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 Target Patients Readout Milestone(s) 2025 Publication TBD 60 Investor Relations | Q1 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#61Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology LNA043-ANGPTL3 agonist Appendix Innovation: Clinical trials Neuroscience Oncology NCT04864392 ONWARDS (CLNA043A12202) Knee osteoarthritis Phase 2 Indication Phase Patients 550 Primary Outcome Measures Arms Intervention 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 Target Patients Readout Milestone(s) Publication TBD References Abbreviations Other 61 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#62Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology remibrutinib - BTK inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology remibrutinib - BTK inhibitor Indication NCT05030311 REMIX-1 (CLOU064A2301) Chronic spontaneous urticaria Indication NCT05032157 REMIX-2 (CLOU064A2302) Chronic spontaneous urticaria Phase Phase 3 Phase Phase 3 Patients 450 Patients 450 Primary Outcome Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint) Measures Primary Outcome Measures Arms Intervention Target Patients 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 Readout Milestone(s) 2024 (Final) Publication TBD 62 Investor Relations | Q1 2023 Results Arms Intervention 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 2024 (Final) Target Patients Readout Milestone(s) Publication TBD 1 NOVARTIS | Reimagining Medicine#63Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 63 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#64Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience MayzentⓇ - S1P1,5 receptor modulator Indication Phase NCT04926818 NEOS (CBAF312D2301) Multiple sclerosis, pediatrics Phase 3 Patients 180 Primary Annualized relapse rate (ARR) in target pediatric participants Outcome Measures 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. 2026 Readout Milestone(s) Publication TBD 64 Investor Relations | Q1 2023 Results Appendix Innovation: Clinical trials Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#65Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Appendix Innovation: Clinical trials Neuroscience Oncology MIJ821 - NR2B negative allosteric modulator (NAM) NCT04722666 (CMIJ821A12201) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Major depressiv disorder with acute suicidal ideation or behavior Phase 2 195 Change from baseline to 24 hours in the total score of the Montgomery Asberg 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 Readout Milestone(s) 2023 (interim) Publication TBD 65 Investor Relations | Q1 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#66Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology remibrutinib - BTK inhibitor NCT05147220 REMODEL-1 (CLOU064C12301) Appendix Innovation: Clinical trials Neuroscience Oncology remibrutinib - BTK inhibitor NCT05156281 REMODEL-2 (CLOU064C12302) Multiple sclerosis References Annualized relapse rate (ARR) of confirmed relapses Indication Multiple sclerosis Indication Phase Phase 3 Phase Phase 3 Patients 800 Patients 800 Primary Outcome Annualized relapse rate (ARR) of confirmed relapses [Core Part]. ARR is the average number of confirmed MS relapses in a year Primary Outcome Measures Measures Arms Intervention Arm 1: Experimental; Remibrutinib - Core (Remibrutinib tablet and matching placebo of teriflunomide capsule) Arms Intervention Arm 2: Active Comparator; Teriflunomide - Core (Teriflunomide capsule and matching placebo remibrutinib tablet) Target Patients Readout 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 Milestone(s) Publication TBD 66 Investor Relations | Q1 2023 Results Abbreviations Other Arm 1: Experimental; Remibrutinib - Core 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 Readout Milestone(s) Publication TBD NOVARTIS | Reimagining Medicine#67Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other ZolgensmaⓇ - SMN1 gene replacement therapy ZolgensmaⓇ - SMN1 gene replacement therapy NCT05089656 STEER (COAV101B12301) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Spinal muscular atrophy (IT administration) Phase 3 125 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 Patients Readout Milestone(s) 2024 Publication TBD 67 Investor Relations | Q1 2023 Results NCT05386680 STRENGTH (COAV101B12302) Spinal muscular atrophy (IT administration) Phase 3B Indication Phase Patients 28 Primary Outcome Measures Arms Intervention 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) Target Patients Readout Milestone(s) Publication 2024 TBD NOVARTIS | Reimagining Medicine#68Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Oncology Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 68 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#69Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology ianalumab - BAFF-R inhibitor NCT05653349 VAYHIT1 (CVAY736112301) Indication Phase 1L Immune Thrombocytopenia Phase 3 Time from randomization to treatment failure (TTF) Patients 225 Primary Outcome Measures Arms Appendix Innovation: Clinical trials Neuroscience Oncology Intervention Arm 1: Experimental: lanalumab Lower dose administered intravenously with corticosteroids oral or parentally (if clinically justified) Arm 2: lanalumab Higher dose administered intravenously with corticosteroids oral or parentally (if clinically justified) Arm 3: Placebo Comparator administered intravenously with corticosteroids oral or parentally (if clinically justified) Adult patients with primary ITP Target Patients Readout Milestone(s) 2025 Publication TBD 69 Investor Relations | Q1 2023 Results ianalumab - BAFF-R inhibitor References Abbreviations Other NCT05653219 VAYHIT2 (CVAY736Q12301) Indication Phase Patients Primary Outcome Measures Arms Intervention 2L Immune Thrombocytopenia Phase 3 150 Time from randomization to treatment failure (TTF) Arm 1: Experimental: eltrombopag and ianalumab lower dose Arm 2: Experimental: eltrombopag and ianalumab higher dose Arm 3: eltrombopag and placebo Primary ITP patients who failed steroids Target Patients Readout Milestone(s) 2025 Publication TBD NOVARTIS | Reimagining Medicine#70Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology ianalumab - BAFF-R inhibitor Conclusions NCT05648968 VAYHIA (CVAY736012301) Warm autoimmune hemolytic anemia Phase 3 Indication Phase Patients 90 Primary Outcome Measures Arms Intervention Target Patients Binary variable indicating whether a patient achieves a durable response Durable response: hemoglobin level ≥10 g/dL and ≥2 g/dL increase from baseline, for a period of at least eight consecutive weeks between W9 and W25, in the absence of rescue medication or prohibited treatment Arm 1: experimental lanalumab low dose (intravenously) Arm 2: experimental lanalumab high dose (intravenously) Arm 3: placebo Comparatorn (intravenously) Previously treated patients with warm Autoimmune Hemolytic Anemia Readout Milestone(s) 2026 Publication TBD 70 Investor Relations | Q1 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#71Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology iptacopan - CFB inhibitor NCT04889430 APPELHUS (CLNP023F12301) Conclusions Atypical haemolytic uraemic syndrome Indication Phase Phase 3 Patients 50 Primary Outcome Measures Arms Intervention Target Patients Percentage of participants with complete TMA response without the use of PE/PI and anti-C5 antibody 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) Readout Milestone(s) 2025 Publication TBD Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 71 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#72Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology JakaviⓇ - JAK1/2 inhibitor Indication Phase NCT03491215 REACH4 (CINC424F12201) Acute graft versus host disease Phase 2 Patients 45 Primary Measurement of PK parameters Outcome Measures Overall Response Rate (ORR) Arms Ruxolitinib Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology Intervention Target Pediatric patients with grade II-IV acute graft vs. host disease after allogeneic hematopoietic stem cell transplantation Patients Readout 2023 Milestone(s) Publication TBD 72 Investor Relations | Q1 2023 Results JakaviⓇ- JAK1/2 inhibitor References Abbreviations Other Indication NCT03774082 REACH5 (CINC424G12201) Chronic graft versus host disease Phase Phase 2 Patients 45 Primary Outcome Overall Response Rate (ORR) 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 Readout Milestone(s) Publication 2023 TBD NOVARTIS | Reimagining Medicine#73Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology 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 Appendix Innovation: Clinical trials Neuroscience Oncology Intervention Target Patients 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. Readout Milestone(s) 2024 Publication NA 73 Investor Relations | Q1 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#74Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology KisqaliⓇ - CDK4 inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology 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 2023 (actual) Readout Milestone(s) Publication TBD 74 Investor Relations | Q1 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#75Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology niseovkitug - TGF-beta 1 inhibitor NCT04935359 daNIS-2 (CNIS793B12301) Indication Phase 1L metastatic pancreatic ductal Adenocarcinoma Phase 3 Patients 501 Primary Outcome Measures Arms Intervention Conclusions 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 Readout Milestone(s) Publication NA 75 Investor Relations | Q1 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#76Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Piqray® - PI3K-alpha inhibitor NCT04729387 EPIK-O (CBYL719K12301) Ovarian Cancer Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology 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 Readout Milestone(s) 2023 Publication TBD 76 Investor Relations | Q1 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#77Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other PluvictoⓇ - Radioligand therapy target PSMA PluvictoⓇ - Radioligand therapy target PSMA NCT04689828 PSMAfore (CAAA617B12302) NCT04720157 PSMAddition (CAAA617C12301) Metastatic hormone sensitive prostate cancer Indication Phase Metastatic castration-resistant prostate cancer, pre-taxane Phase 3 Indication Phase Phase 3 Patients 450 Patients 1126 Primary Radiographic Progression Free Survival (rPFS) Primary Outcome Outcome Measures Measures Arms Arms Intervention Intervention Target Patients Arm 1: Participants will receive 7.4 GBq (200 mCi) +/- 10% 177 Lu-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 (actual) Readout Milestone(s) Final Analysis: 2025 Publication TBD 77 Investor Relations | Q1 2023 Results Radiographic Progression Free Survival (rPFS) Arm 1: 177Lu-PSMA-617 Participant will receive 7.4 GBq (+/- 10%) 177 Lu-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) Target Patients Readout Milestone(s) Publication Primary Analysis: 2024 TBD NOVARTIS | Reimagining Medicine#78Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience 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) Readout Milestone(s) 2026 Publication TBD Appendix Innovation: Clinical trials Oncology References Abbreviations Other 78 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#79Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology sabatolimab - TIM3 antagonist NCT04150029 STIMULUS-AML1 (CMBG453C12201) Unfit acute myeloid leukaemia Phase 2 Indication Phase Patients 86 Primary Outcome Measures Arms Intervention 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 Readout Milestone(s) 2023 Publication TBD 79 Investor Relations | Q1 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology sabatolimab - TIM3 antagonist NCT04266301 STIMULUS-MDS2 (CMBG453B12301) Indication Phase Myelodysplastic syndrome Phase 3 Patients 500 Primary Overall survival Outcome Measures Arms References Abbreviations Other 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) Intervention Target Patients Readout Milestone(s) Publication 2024 TBD NOVARTIS | Reimagining Medicine#80Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology 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 Conclusions Intervention 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 Target Patients - - Dasatinib 100 mg QD - Bosutinib 400 mg QD Patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase Readout Milestone(s) 2024 Publication TBD 80 Investor Relations | Q1 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#81Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology TNO155-SHP2 inhibitor Indication Phase NCT03114319 (CTNO155X2101) Solid tumors (single agent) Phase 1 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 Readout Milestone(s) Publication 2024 TBD Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 81 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#82Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology Ophthalmology Other Conclusions Neuroscience Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 82 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#83Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology Ophthalmology Conclusions Ophthalmology Neuroscience Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 83 Investor Relations | Q1 2023 Results 1 NOVARTIS | Reimagining Medicine#84Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology BeovuⓇ - VEGF Inhibitor NCT04278417 CONDOR (CRTH258D2301) Indication Diabetic retinopathy Phase Phase 3 Patients 694 Primary Change from Baseline in BCVA Outcome Measures Arms Conclusions Intervention Target Patients Arm 1: RTH258 (brolucizumab) 6 mg/50uL Arm 2: Panretinal photocoagulation laser initial treatment followed with additional PRP treatment as needed Patients with proliferative diabetic retinopathy Readout Milestone(s) Publication 2024 TBD Neuroscience Global Health Appendix Innovation: Clinical trials References Abbreviations Oncology Other Biosimilars 84 Investor Relations | Q1 2023 Results 1 NOVARTIS | Reimagining Medicine#85Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology libvatrep - TRPV1 antagonist NCT04630158 SAHARA (CSAF312B12201) Chronic ocular surface pain Indication Phase Phase 2 Patients 150 Primary Outcome Measures Arms Intervention Change in mean pain severity Visual Analog Scale Conclusions Neuroscience Global Health Target Patients 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. Readout Milestone(s) 2023 Publication 2023 85 Investor Relations | Q1 2023 Results Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 1 NOVARTIS | Reimagining Medicine#86Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology Global Health Conclusions Neuroscience Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 86 Investor Relations | Q1 2023 Results 1 NOVARTIS | Reimagining Medicine#87Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology Adakveo® - P-selectin inhibitor NCT03474965 SOLACE-Kids (CSEG101B2201) Indication Sickle cell disease, pediatrics Phase 2 PK/PD and safety of SEG101 at 5 mg/kg Phase Patients 100 Primary Outcome Measures Arms Conclusions Neuroscience Global Health Intervention Target Patients Readout Milestone(s) Publication 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 87 Investor Relations | Q1 2023 Results Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 1 NOVARTIS | Reimagining Medicine#88Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology cipargamin - PfATP4 inhibitor Conclusions NCT04675931 KARISMA (CKAE609B12201) Malaria severe Indication Phase Phase 2 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 Readout Milestone(s) Publication 2024 TBD Neuroscience Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 88 Investor Relations | Q1 2023 Results 1 NOVARTIS | Reimagining Medicine#89Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology Conclusions Neuroscience Global Health CoartemⓇ - PGH-1 (artemisinin combination therapy) NCT04300309 CALINA (CCOA566B2307) Malaria, uncomplicated (<5kg patients) Phase 3 Indication Phase Patients 44 Primary Outcome Measures Arms Intervention Artemether Cmax 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 Readout Milestone(s) Publication TBD Appendix Innovation: Clinical trials References Abbreviations Oncology Other Biosimilars 89 Investor Relations | Q1 2023 Results 1 NOVARTIS | Reimagining Medicine#90Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology ganaplacide - Non-artemisinin plasmodium falciparum inhibitor NCT04546633 KALUMI (CKAF156A2203) Conclusions Indication Malaria, uncomplicated Phase Phase 2 Patients 292 Primary Outcome Measures Arms Intervention PCR-corrected and uncorrected Adequate Clinical and Parasitological Response (ACPR) 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 Target Patients Malaria patients 6 months to < 18 years old Readout Milestone(s) Publication 2023 TBD Neuroscience Global Health Appendix Innovation: Clinical trials References Abbreviations Oncology Other Biosimilars 90 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#91Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology Biosimilars Conclusions Neuroscience Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 91 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#92Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology aflibercept - VEGF inhibitor Conclusions Neuroscience Global Health NCT04864834 Mylight (CSOK583A12301) Ophthalmology indication (as originator) Indication Phase Phase 3 Patients 460 Primary Outcome Measures Arms Intervention Target Patients 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 Readout 2023 Milestone(s) Publication tbd Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 92 Investor Relations | Q1 2023 Results NOVARTIS | Reimagining Medicine#93Company overview Innovation: Pipeline overview Abbreviations Financial review Financial performance Conclusions Appendix Innovation: Clinical trials References Abbreviations ΑΙ АІН aHUS ALL ALS AML Auto-injector Autoimmune hepatitis atypical Hemolytic Uremic Syndrome Acute lymphoblastic leukemia Amyotrophic lateral sclerosis Acute myeloid leukemia IgAN IPF ITP LBCL BC Breast cancer LN mCRPC MDS IgA nephropathy Idiopathic pulmonary fibrosis Immune thrombocytopenia Large B-cell lymphoma Lupus nephritis Metastatic castration-resistant prostate cancer Myelodysplastic syndrome C3G C3 glomerulopathy MHSPC Metastatic hormone sensitive prostate cancer CART Chimeric androgen receptor T mPDAC Metastatic pancreatic ductal adenocarcinoma CLL Chronic lymphocytic leukemia CML Chronic myeloid leukemia MS NASH Multiple sclerosis CRC Colorectal cancer nmCRPC COPD Chronic obstructive pulmonary disease NPR1 COSP Chronic ocular surface pain nr-axSpA CSU Chronic spontaneous urticaria NSAI 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 NSCLC Non-alcoholic steatohepatitis Non-metastatic castration-resistant prostate cancer Natriuretic peptide receptor 1 Non-radiographic axial spondyloarthritis Non-steroidal aromatase inhibitor Non-small cell lung cancer OS Overall survival PFS Prefilled syringe DLBCL Diffuse large B-cell lymphoma refractory PNH Paroxysmal nocturnal haemoglobinuria ESCC FL GCA GVHD GRPR HCC HD Esophageal squamous-cell carcinoma Follicular lymphoma Giant cell arteritis Graft-versus-host disease Gastrin releasing peptide receptor Hepatocellular carcinoma Huntington's disease PsA Psoriatic arthritis rHR Resistant hypertension rMS rPFS SLE Relapsing multiple sclerosis Radiographic progression free survival Systemic lupus erythematosus SMA Type 1 Spinal muscular atrophy (IV formulation) HR LBCL High risk large B-cell lymphoma SpA IA Interim analysis T1DM SMA Type 2/3 Spinal muscular atrophy (IT formulation) Spondyloarthritis Type 1 Diabetes mellitus iAMD Intermediate age-related macular degeneration WAIHA Warm autoimmune hemolytic anemia IC-MPGN Immune complex membranoproliferative glomerulonephritis 93 Investor Relations | Q1 2023 Results U NOVARTIS | Reimagining Medicine#94Company overview Financial review Conclusions Appendix References References CosentyxⓇ Matusiak Ł. Br J Dermatol. 2020;183(6):e171-e177. 1 2 G6 market estimations based on IQVIA PADDS 2021. 3 Kimball A, et al. N Engl J Med. 2016;375:422-434. 4 Data on file. IQVIA PADSS. Novartis Pharmaceuticals Corp; March 2023. 5 Kimball A, et al. Lancet. 2023;401(10378):747-761. 6 Post hoc analysis: patients with moderate to severe pain at baseline who improved to mild or no pain at Week 52. 7 Novartis data on file. SUNNY Clinical Study Program pooled data tables and post hoc analyses. 8 Between 1 in 100 and 1 in 1,000 exposed patients. KesimptaⓇ 1 March 2023, IQVIA NPA (KesimptaⓇ) and IQVIA NPA adjusted by NSP (all others). B-cell therapies as portion of MS market in NBRx. Refers to US unless otherwise stated. 2 3 Data on file. 4 The initial dosing period consists of 20 mg subcutaneous doses at Weeks 0, 1 and 2, thereafter once a month. Patient must take pen out of the refrigerator 15-30 minutes before self-administering. 5 Efficacy outcomes as measured by disability progression and brain volume change. 6 Cohen et al, Poster presented at American Academy of Neurology, Boston, 22-27 April 23. 7 Cohen et al, oral presentation at American Academy of Neurology, Boston, 22-27 April 23. ZolgensmaⓇ 1 Based on US SMA incidence from NBS data & Zolgensma sales in eligible patients. 2 Wave 3 and 4 launch countries. 3 Mendell J. et al. Long-Term Follow-Up of Onasemnogene Abeparvovec Gene Therapy in Symptomatic Patients with Spinal Muscular Atrophy Type 1. Abstract presented at the 2023 MDA Clinical & Scientific Conference. March 19-22,2023. 4 Connolly A. et al. Intravenous and Intrathecal Onasemnogene Abeparvovec Gene Therapy in Symptomatic and Presymptomatic Spinal Muscular Atrophy: Long-Term Follow-Up Study. Abstract presented at the 2023 MDA Clinical & Scientific Conference. March 19-22, 2023. 5 All but one achieved walking alone milestone before or without added therapy at the last data cut (May 2022). 94 Investor Relations | Q1 2023 Results 1 NOVARTIS | Reimagining Medicine

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Expansion of Austrian Logistics Infrastructure image

Expansion of Austrian Logistics Infrastructure

Logistics Infrastructure

Stevanato Group Investor Presentation image

Stevanato Group Investor Presentation

Investor Relations

Straits Trading Business Segments Overview image

Straits Trading Business Segments Overview

Investor Relations

DECEMBER 2021 INVESTOR PRESENTATION image

DECEMBER 2021 INVESTOR PRESENTATION

Investor Relations

CEMENT MANUFACTURING IN RWANDA image

CEMENT MANUFACTURING IN RWANDA

Investor Relations

Third Quarter 2021 Investor Relations Handout image

Third Quarter 2021 Investor Relations Handout

Investor Relations

2023 INVESTOR DAY image

2023 INVESTOR DAY

Investor Relations

Q2 2019 Fixed Income Investor Presentation image

Q2 2019 Fixed Income Investor Presentation

Investor Relations/Fixed Income