Novartis Q4 Results

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#1↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix References Q4 2023 Results Investor presentation January 31, 2024 & NOVARTIS | Reimagining Medicine NOVARTIS T#2↓ ↑ Content Click below to navigate through the document Company overview Disclaimer Financial review Conclusions Appendix References 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," "confident," 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 results of ongoing clinical trials; or regarding ongoing or future share repurchases; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings; or by discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or regarding our approximate estimated peak sales, sales potential and other financial information; or regarding our capital structure; or regarding our focus on material environmental, social and governance factors; or regarding the consequences of the spin-off of Sandoz and our transformation into a “pure-play" innovative medicines company. 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: uncertainties regarding the success of key products, commercial priorities and strategy; uncertainties in the research and development of new products, including clinical trial results and additional analysis of existing clinical data; uncertainties regarding the use of new and disruptive technologies, including artificial intelligence; 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 our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; our ability to realize the intended benefits of our separation of Sandoz into a new publicly traded standalone company; 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; our performance on environmental, social and governance matters uncertainties in the development or adoption of potentially transformational digital technologies and business models; uncertainties surrounding the implementation of our new IT projects and systems; uncertainties regarding potential significant breaches of information security or disruptions of our information technology systems; uncertainties regarding actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this presentation; safety, quality, data integrity, or manufacturing issues; our performance on and ability to comply with environmental, social and governance measures and requirements; major political, macroeconomic and business developments, including impact of the war in certain parts of the world; 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. AVROBIO is a registered trademark of AVROBIO, Inc. Voyager Therapeutics is a registered trademark of Voyager Therapeutics, Inc. Bicycle Therapeutics is a registered trademark of Bicycletx Limited. Clovis Oncology is a registered trademark of Clovis Oncology, Inc. Ionis is a registered trademark of lonis Pharmaceutics, Inc. Legend Biotech is a registered trademark of Nanjing Legend Biotech Co., Ltd. Chong Kun Dang is a registered trademark of Chong Kun Dang Holdings Corp. Isomorphic Labs is a registered trademark of Isomorphic Labs Limited. □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 2#3↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix References Company overview Vas Narasimhan, M.D. Chief Executive Officer □ NOVARTIS Reimagining Medicine#4Content Click below to navigate through the document Novartis delivers strong full year performance with margin expansion. Continuing innovation momentum with multiple positive Ph3 readouts ↓ ↑ Company overview Core margin 36.0% (+240 bps) Core Oplnc USD 16.4bn Several major innovation milestones in Q4 FabhaltaⓇ (iptacopan) US approval in PNH CosentyxⓇ US approval in HS Cosentyx® US approval of IV formulation (PSA, AS, nr-axSpA) Iptacopan Ph3 APPLAUSE study met its primary endpoint in IgAN Atrasentan Ph3 ALIGN study met its primary endpoint in IgAN Iptacopan Ph3 APPEAR-C3G met its primary endpoint in C3G ScemblixⓇ Ph3 ASC4FIRST met primary endpoints in 1L Ph+ CML-CP (Jan) Financial review Conclusions Appendix References Double-digit growth for sales and Core Oplnc for the quarter and full year¹ Growth vs. PY, CC Core margin 33.5% (+100 bps) 18% 13% 10% 10% Sales USD 11.4bn Core Oplnc USD 3.8bn Sales USD 45.4bn Q4 FY Successful spin-off of Sandoz FY 2024 guidance¹: Sales expected to grow mid single digit; Core Oplnc expected to grow high single digit Mid-term guidance¹ updated: Sales expected to grow +5% cc CAGR 2023-28; core operating income margin -40%+ by 2027 - Oplnc operating income. 1. As defined on page 37 of the Condensed Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 49 of Condensed Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 4#5↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix References Completed the transformation; laying the foundation for our future growth Strategy AH Vx OTC FY 2014 Pre-portfolio transformation Alcon Innovative Sandoz Medicines FY 2023 Focused company Pure-play Innovative Medicines Operations Core margin FCF (USD) as % of sales Innovation 25.2% 11.1bn 19.1% 36.0% 13.2bn 29.0% 10 positive Ph3 readouts on assets with significant sales potential 2014 figures reflecting revised free cash flow definition, 2023 figures reflect Continuing Operations. As defined on page 37 of the Condensed Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 5 LO#6Content Click below to navigate through the document Strong Q4 growth driven by performance from EntrestoⓇ, KesimptaⓇ, KisqaliⓇ and CosentyxⓇ ↓ ↑ Company overview Financial review Conclusions Appendix References Q4 sales Entresto sacubitril/valsartan Kesimpta (ofatumumab) 20 mg injection KISQALI ribociclib Sales USD million 1,635 641 Growth vs. PY USD million 344 272 610 253 Cosentyx 1,303 223 (secukinumab) 273 PLUVICTO™ 94 LEQVIO® 123 81 • SCEMBLIX® 125 (asciminib) 20 mg. 40 mg tablets 73 ILARIS 376 (canakinumab) 150 ra niezione sottocutanes 75 JAKAVI® 444 56 ruxolitinib Xolair 378 55 Omalizumab FOR SUBCUTANEOUS USE PROMACTA® (eltrombopag) 563 23 GROWTH Growth vs. PY CC 26% 73% 76% Strong growth (+40% cc); 21% * 53% expected to continue 190% 143% 29% 14% 16% 4% * Benefitting from lower prior year base. Constant currencies (cc) is a non-IFRS measure; explanation of non-IFRS measures can be found on page 49 of Condensed Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 6#7Entresto Content Click below to navigate through the document EntrestoⓇ delivers 31% FY growth with sales reaching USD 6bn. Expecting USD 7bn peak sales GROWTH ↓ ↑ Company overview Financial review Conclusions Appendix References Sales evolution USD m, % cc US Ex-US 1,291 US weekly TRX1 Continues strong momentum in Q4 Total prescriptions (000) FY USD 6.0bn +31% . US: +27% CC 120 . Ex-US: +26% CC ~1.4m TRx 110 in Q41 +26% · 100 China/Japan: Contribution from HTN2 1,635 90 080 80 Confidence in future growth 70 755 597 660 60 50 40 40 30 880 694 20 10 0 Q4 2022 Q4 2023 July 2015 Dec 2023 . · Strong guidelines position³ (US/EU) Further penetration in HF and HTN US: Forecasting purposes, we assume EntrestoⓇ LoE in 2025 EU: RDP to Nov 20264 See last page for references (footnotes 1-4). HTN hypertension. - LOE loss of exclusivity. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 49 of Condensed Financial Report. RDP - Regulatory data protection. □ NOVARTIS | Reimagining Medicine. TRX total prescriptions. HF - heart failure. Novartis Q4 Results | January 31, 2024 7#8↓ ↑ Content Click below to navigate through the document CosentyxⓇ FY sales reached USD 5bn¹. Expect mid to high single-digit growth in 2024 and USD 7bn peak sales GROWTH Company overview Financial review Conclusions Appendix References Sales evolution USD m, % cc US Ex-US 1,080 447 +21%* FY USD 5.0bn1 +5% 1,303 Q4 performance benefitted from lower PY base • US +17% cc; Ex-US sales +26% cc Lower PY base in US due to revenue deduction adjustments • Launched IV and HS in US FY 2024: Expect mid to high single-digit growth 562 . US/EU: HS launch 741 633 Q4 2022 * Benefitting from lower prior year base Q4 2023 HS - moderate to severe hidradenitis suppurativa in adult population. IV - intravenous. non-IFRS measures; explanation can be found on page 49 of Condensed Financial Report. □ NOVARTIS | Reimagining Medicine. • US: IV launch in adult PsA, AS and nr-axSpA . . China: PsA approved January 2024 Further CosentyxⓇ innovation 3 Ph3 studies ongoing: Giant Cell Arteritis, Polymyalgia Rheumatica, Rotator Cuff Tendinopathy Cosentyx PSA - psoriatic arthritis. AS ankylosing spondylitis. 1. Rounded from USD 4.98bn. - nr-axSpA - non-radiographic axial spondyloarthritis. Constant currencies (cc), core results are Novartis Q4 Results | January 31, 2024 8#9↑ Content Click below to navigate through the document KesimptaⓇ FY sales doubled (USD 2.2bn) and on track for USD 4bn peak based on compelling product profile GROWTH ↓ Company overview Financial review Conclusions Appendix References Sales evolution USD m, % cc US Ex-US 369 63 Launch momentum continues across all regions FY USD 2.2bn +99% • >85k patients treated, majority naive or first switch¹ ● US (+48% cc in Q4): Demand-driven growth +73% • 641 Ex-US (+193% cc in Q4): NBRx leadership in 7/10 major markets² Compelling product profile 188 • Clinically meaningful efficacy superiority over teriflunomide³ Kesimpta • 1 minute a month dosing at home/anywhere4 • ~90% find Kesimpta SensoreadyⓇ pen easy and simple to use (US RWE study) 5,6 453 • 5-year efficacy7, safety and tolerability data 8,9 306 Q4 2022 Q4 2023 See last page for references (footnotes 1-9). NBRX - new to brand prescription. Report. - MS Multiple Sclerosis. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 49 of Condensed Financial □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 9#10↓ ↑ Content Click below to navigate through the document KisqaliⓇ FY sales reached USD 2.1bn in metastatic breast cancer (mBC). Maintain USD 4bn peak sales guidance for mBC GROWTH Company overview Financial review Conclusions Appendix References Sales evolution USD m, % cc US Ex-US 357 +76% FY USD 2.1bn +75% 610 278 US MBC NBRx share1 Rolling 3 months, % 208 26% 332 149 Q4 2022 Q4 2023 Nov 2022 46% Nov 2023 Expect continued strong sales momentum in mBC KISQALI® . . Statistically significant OS benefit proven across all 3 Ph3 pivotal trials² Recognized by NCCN guidelines with Category 1 designation for 1L and highest score by ESMO-MCBS3 Median OS of ~5 years across all 3 pivotal trials when combined with letrozole or fulvestrant in 1L mBC Adjuvant indication · Filed in EU, US and China mBC metastatic breast cancer. NBRX - new to brand prescription. NCCN – national comprehensive cancer network. Al - aromatase inhibitor. 1. Of CDK4/6 mBC market, US 3 months ending Nov 2023, IQVIA Breast Cancer Market Sizing report. 2. MONALEESA-2: Hortobagyi et al, NEJM 2022; MONALEESA-7: Lu et al, Clin Cancer Res 2022; MONALEESA-3: Neven et al, ESMO Breast 2022. 3. NCCN Guidelines updated as of 27-Jan-2023. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 49 of Condensed Financial Report. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 10#11↓ ↑ Content Click below to navigate through the document PluvictoⓇ FY sales close to blockbuster. Supply now unconstrained. Maintain multi-bn peak sales guidance for current indication (post-taxane) Company overview Financial review Conclusions Appendix References Sales evolution USD m, % cc US Ex-US +53% FY USD 980m +261% • Q4 sales grew YoY (+53% cc) and QoQ (+7% USD) driven by demand 273 22 179 9 251 170 Q4 2022 Q4 2023 GROWTH PLUVICTOⓇ • • • Treatment sites: 300+ US sites, vast majority active and regularly ordering Unconstrained supply: 99.9% of doses injected on planned day in Q4 in US: approval of Indianapolis site to increase capacity to 250k RLT doses in 2024 Global network expansion: RLT facility investment in China and Japan Confident in 2024: Expect return to stronger QoQ growth following earlier supply disruption Additional indications . PSMAfore (pre-taxane) expect US submission in H2 2024 Additional studies in earlier stages of disease (PSMAddition in mHSPC, PSMA-DC in localized oligometastatic disease) Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 49 of Condensed Financial Report. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 11#12↓ ↑ Content Click below to navigate through the document ScemblixⓇ continues strong launch trajectory, driven by increasing recognition of its differentiated profile and high unmet need in CML Company overview Financial review Conclusions Appendix References Sales evolution USD m US Ex-US FY USD 413m +179% +143% 125 43 GROWTH SCEMBLIX® (asciminib) 20 mg, 40 mg tablets • • FY and Q4 sales more than doubled driven by highly differentiated profile Leading 3L+ market share in US (NBRx 43%, TRX 22%) and ex-US (TRX 28%)1 High unmet need in 3L patients: >50% of hematologists aim to improve quality of life and management of side effects² ASCEMBL Ph3 data 3L with nearly 4 years of follow-up reinforces differentiated profile vs. alternative TKIs; with sustained efficacy and safety benefit³ Global rollout in 3L ongoing with approval in 60+ countries; access pathways in 25+, with consistently positive feedback from payers on added clinical benefit 52 . 10 82 42 Q4 2022 Q4 2023 3. Mauro M.J. et Ph+ CML-CP - Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. 1. US: October rolling 3-months US IQVIA CML market sizing report (Jan 2024). Ex-US: IPSOS & IQVIA Oncology Dynamics, EU5 and JP, MAT October 2023). 2. Survey on unmet needs in CML at EHA: reveals the need for treatment decisions that balance quality of life, efficacy, and tolerability goals; Chronic Myeloid Leukemia Survey on Unmet Needs (CML SUN). al., ASH 2023, Poster 4536 (median follow-up of 3.7 years). Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 49 of Condensed Financial Report. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 12#13Content Click below to navigate through the document ScemblixⓇ: ASC4FIRST trial met both primary endpoints with clinically meaningful and statistically significant results INNOVATION ↓ ↑ Company overview Financial review Conclusions Appendix Both primary endpoints met . Scemblix shows superior MMR rates at week 48 vs. SoC TKIs in newly diagnosed Ph+ CML-CP patients Favorable safety and tolerability profile with fewer AEs and treatment discontinuations vs. SoC TKIs and no new safety signals were observed Achievement of MMR BCR-ABL1 ≤ 0.1% is associated with References . ● higher rates of EFS, PFS and OS1 Study design Primary endpoint Week 48 Secondary endpoint End of study Week 96 5 years MMR evaluation ScemblixⓇ 80mg once-daily R N=405 1:1 Investigator-selected TKI 50% 1G TKI: imatinib 50% 2G TKI: nilotinib or dasatinib or bosutinib Population: Newly diagnosed adult patients with CML-CP with no prior TKI Primary endpoints as assessed by MMR at 48 weeks: Superiority of ScemblixⓇ vs. 1) investigator choice TKI and/or 2) imatinib subgroup alone Data will be presented at an upcoming medical congress | CML-CP 1L FDA submission anticipated in H1 2024 CML-CP - chronic myeloid leukemia in chronic phase. MMR - major molecular response (BCR-ABL 1IS ≤0.1%). SoC Standard of care. al., Leukemia; 34:966-84, 2020. - TKI - tyrosine kinase inhibitor. 1. Saussele S et al. Leukemia; 32(5):1222-8; 2018; Hochhaus et □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 13#14↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix References LeqvioⓇ adoption continues to expand across regions Sales evolution USD m, % cc US Ex-US FY USD 355m +217% +190% 123 GROWTH US: Steady growth, ahead of advanced lipid lowering market¹ Adoption • 3,500 facilities have ordered Leqvio® (+13% vs. Q3) ~55% of business is from in-office buy & bill Continued execution on growth enablers • Depth is increasing in key accounts • Buy & bill is fastest growing acquisition channel Improved HCP targeting driving increase in breadth and depth Ex-US: Rollout continues 29 countries with public reimbursement • 39 countries have private (commercial) coverage LEQVIO® (inclisiran) • 54 42 17 69 25 Q4 2022 Q4 2023 - HCP healthcare professional. 1. Includes PCSK9 mAbs and bempedoic acid. □ NOVARTIS | Reimagining Medicine. • Solid early uptake in China self-pay market Outcomes trials . On track for readout 2026+ Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 49 of Condensed Financial Report. Novartis Q4 Results | January 31, 2024 14#15↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix FabhaltaⓇ1: FDA approved with compelling label in PNH Positive early launch signals, expect modest ramp Strong product profile reflected in label Compelling data . References • . Hb improvement vs. C5i in patients with residual anemia Transfusion avoidance Comprehensive IVH and EVH control Broad population Oral administration First oral monotherapy REMS requirements similar to other complement inhibitors · Adults with PNH . Naive and switch 300781189209 GROWTH FABHALTA (iptacopan) 200 mg capsules Reco NDC 0078-1189-20 Rx only Eest FABHALTA (iptacopan) capsules Ston екси and 200 mg Dispenso with accompanying Medication Guide. 60 capsules Swallow the capsules whole. Do not open, break, or chew capsules NOVARTIS mac DE E . Demonstrated safety profile Positive early launch signals, expect modest ramp Launch execution • Promotion started early Dec incl. at ASH . REMS and patient support programs live First patients initiated shortly after approval Sentiment · Positive HCP sentiment on efficacy, safety and oral profile Strong interest from patients/patient groups Access • Distribution with two national specialty pharmacies Bridge support in place pending payer coverage PNH - paroxysmal nocturnal hemoglobinuria. C5i complement 5 inhibitor. IVH - intravascular hemolysis. EVH - extravascular hemolysis. REMS-risk evaluation and mitigation strategies. HCP - healthcare professional. 1. Iptacopan is the generic name for unapproved indications. □ NOVARTIS | Reimagining Medicine. ASH American Society of Hematology. Novartis Q4 Results | January 31, 2024 15#16↓ ↑ Content Click below to navigate through the document Achieved our innovation milestones in 2023 10 positive Ph3 readouts for medicines with significant sales potential1 Company overview Financial review Conclusions Appendix Regulatory decisions Cosentyx® HS Cosentyx® 2ml Al Cosentyx® IV FabhaltaⓇ (iptacopan) PNH Leqvio® Hypercholesterolemia References Submissions Iptacopan PNH (US/EU/JP) Kisqali® HR+/HER2- BC (adj) PluvictoⓇ mCRPC, pre-taxane (US) Atrasentan IgAN Status update - as of end Q4 EU approval (Q2), US approval (Q4) US approval (Q2) US approval (Q4) US approval (Q4) Japan and China approval in Q3 Filed in US, EU (Q2), JP (Q3) Filed in EU in Q3, in US in Q4 10 positive Ph3 readouts 1 KisqaliⓇ eBC NATALEE 2 Iptacopan PNH APPOINT 3 Remibrutinib CSU REMIX-1 4 Remibrutinib CSU REMIX-2 INNOVATION Readouts Kisqali® HR+/HER2-BC (adj) Iptacopan IgAN Iptacopan C3G LutatheraⓇ GEP-NETS Ph3 starts Remibrutinib CSU Iptacopan in IC-MPGN Leqvio® CVRR primary prevention lanalumab in immune thrombocytopenia lanalumab in systemic lupus erythematosus US submission expected in 2024 Met pre-specified interim analysis primary endpoint in Q4 Primary endpoint met at interim analysis; 500 iDFS event milestone reached; data consistent with interim analysis (March 20232) Met pre-specified interim analysis primary endpoint in Q3 Met primary endpoint in Q4 Met primary endpoint in Q3 Met primary endpoint in Q4. APPARENT trial (Q2) VICTORION-1P (Q1) 1L (VAYHIT1) and 2L (VAYHIT2) (H1) SIRIUS-SLE 1 and 2 (Q1) 5 LutatheraⓇ GEP-NETS NETTER-2 6 Iptacopan IgAN APPLAUSE 7 PluvictoⓇ mCRPC pre-taxane PSMAfore 8 Atrasentan IgAN ALIGN 9 Iptacopan C3G APPEAR 10 ScemblixⓇ 1L CML ASC4FIRST (Jan 2024) - HS hidradenitis suppurativa. C3G PNH - paroxysmal nocturnal hemoglobinuria. mCRPC – metastatic castration-resistant prostate cancer. FIR - first interpretable results. IgAN immunoglobulin A nephropathy. complement 3 Glomerulopathy. IC-MPGN - immune complex membranoproliferative glomerulonephritis. 1. Readout or presentations 2. Interim analysis in March 2023, data presented at ASCO 2023. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 16#17↓ ↑ INNOVATION Content Click below to navigate through the document Company overview Financial review Conclusions Appendix References Iptacopan: Ph3 APPEAR study demonstrates clinically meaningful and statistically significant proteinuria reduction in patients with C3G Ph2 showed sustained benefits up to 1 year Primary endpoint native kidney 24 h UPCR geometric mean ration to baseline (95% CI) 1.0 0.8- 0.6 0.4 Model estimated geometric mean ratio to baseline (95% CI) plot of 24 h UPCR (g/mol) Ph3 met primary endpoint³ . Clinically meaningful and statistically significant proteinuria reduction at six-month analysis Safety profile consistent with previously reported data . Simple administration: Oral Study design B D 28 D 84 D 354 Visit (days) Cohort A 16 15 16 15 Blinded treatment Iptacopan 200mg BID Primary endpoint analysis Open-label treatment Iptacopan 200mg BID End of study Primary endpoint transplanted kidney² Baseline biopsy Week 12 biopsy Review results with health authorities for potential submissions in 2024 RH 1:1 N = 74 Placebo Iptacopan 200mg BID Day 1 Month 6 Option to roll-over Month 12 in OLE RoE - Roll-over extension. UPCR urine protein creatinine ratio. CI confidence interval. 1. ASN 2022 poster. 2. Kidney biopsy baseline → Week 12 C3 Deposit Score. Wong EK, et al. ePoster ASN 2021. 3. December 2023. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 17#18Content Click below to navigate through the document Iptacopan and atrasentan: Positive Ph3 readouts demonstrating clinically meaningful proteinuria reduction in IgAN INNOVATION ↓ ↑ Company overview Financial review Assets Conclusions Positive clinically meaningful IA1 (primary endpoint) 2021 2022 2023 2024 2025 2026+ Comments Iptacopan Ph3 - APPLAUSE * Positive clinically meaningful IA1 (primary endpoint) Ph3 - BEYOND² UPCR submission-enabling readout expected 2026 References Atrasentan Ph3 - ALIGN * Appendix Zigakibart * US submission for accelerated approval Iptacopan and atrasentan FDA submissions expected in H1 2024, based on proteinuria reduction Studies continue to confirmatory endpoint (eGFR) in 2025 - UPCR urine protein creatinine ratio. 1. October 2023, 9 months readout may support US submission for accelerated approval. 2. Global, randomized, multicenter, double-blind, placebo-controlled Ph3 comparing safety and efficacy of zigakibart (600mg Q2W) vs. placebo in patients (N-272) with IgAN at risk of progressive loss of kidney function. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 18#19↑ Content Click below to navigate through the document Expect to continue our innovation momentum in 2024... ↓ Company overview Financial review Conclusions Appendix 2024 selected key events (expected) Regulatory decisions Submissions FabhaltaⓇ PNH References H1 2024 H2 2024 EU, JP US, EU Kisqali® HR+/HER2- adj.BC Atrasentan IgAN US Iptacopan C3G US EU Iptacopan IgAN US PluvictoⓇ mCRPC, pre-taxane US Remibrutinib CSU US, EU, JP ScemblixⓇ CML 1L LutatheraⓇ GEP-NET 1L G2/G3 US EU JP Readouts ScemblixⓇ CML 1L Ph3 (ASC4FIRST) Ph3 starts ZolgensmaⓇ SMA IT XXB750 Hypertension PluvictoⓇ Oligometastatic prostate cancer Opnurasib 1L NSCLC (combo)1 Ph3 Ph2/3 Ph3 (STEER) Ph2 INNOVATION - C3G complement 3 Glomerulopathy. IgAN-immunoglobulin A nephropathy. FIR - first interpretable results. NSCLC Non-small cell lung cancer. - 1. This is a seamless Ph2/3 trial. - PNH paroxysmal nocturnal hemoglobinuria. mCRPC – metastatic castration-resistant prostate cancer. CCSU - Chronic spontaneous urticaria. CML - Chronic myeloid leukemia. SMA Spinal muscular atrophy. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 19#20Content Click below to navigate through the document . and to deliver >20 key submissions in core therapeutic areas by 2028 INNOVATION ↓ ↑ Company overview Financial review Conclusions Appendix Select key assets submission schedule Core therapeutic areas 2024 References CRM atrasentan IgAN1 Immunology iptacopan IgAN1 2025 pelacarsen CVRR-Lp(a) CosentyxⓇ Tendinopathy PluvictoⓇ MHSPC2 CosentyxⓇ Polymyalgia rheumatica ianalumab 2L ITP 2026-2028 ianalumab Sjögren's syndrome ianalumab Lupus Nephritis ianalumab SLE me PluvictoⓇ Oligometastatic PC remibrutinib CINDU remibrutinib Multiple sclerosis Neuroscience iptacopan ZolgensmaⓇ C3G SMA IT Oncology remibrutinib CSU PluvictoⓇ mCRPC, pre-taxane ScemblixⓇ CML 1L 1. US submission for accelerated approval. 2. Event-driven trial endpoint. CosentyxⓇ GCA LeqvioⓇ Hyperlipidemia ped □ NOVARTIS | Reimagining Medicine. را ianalumab 1L ITP iptacopan IC-MPGN ianalumab LeqvioⓇ WAIHA CVRR-LDLC zigakibart igAN & Novartis Q4 Results | January 31, 2024 20#21↓ ↑ INNOVATION Content Click below to navigate through the document We have signed >15 strategic deals during the last year, totaling >6bn USD, to enhance our pipeline across core therapeutic areas and technology platforms Company overview Financial review Select recent examples Conclusions Appendix 信瑞诺 SanReno Calypso CHINOOK biotech THERAPEUTICS THERAPEUTICS References IONIS XRNA Argo Biopharma XRNA Chong Kun Dang Pharm. Seoul, Korea CRM CLOVIS ONCOLOGY RLT voyager Gene therapy Bicycle RLT therapeutics AVROBIO Gene DTX XRNA PHARMA therapy Note: Number of strategic M&A and BD&L transactions announced, value reflecting upfront payments. □ NOVARTIS | Reimagining Medicine. LEGEND Cell BIOTECH therapy 14 Isomorphic Labs Immunology Neuroscience Oncology Novartis Q4 Results | January 31, 2024 21#22↓ ↑ Content Click below to navigate through the document Updating mid-term sales guidance: Expect to grow +5% CAGR 2023-2028 and maintaining core margin of ~40%+ by 2027 Company overview Financial review Conclusions Updated mid-term guidance 2023-2028 +5% (cc) expected sales CAGR (previous guidance 2022-27) Illustrative net sales, cc Appendix References 2023 Core margin 36% Mainly EntrestoⓇ PromactaⓇ TasignaⓇ Sandostatin LAR® Gx impact¹ up to 2028 +5% CAGR CC Mainly Fabhalta® ScemblixⓇ (1L) remibrutinib Mainly Kisqali® PluvictoⓇ Leqvio® atrasentan pelacarsen KesimptaⓇ ScemblixⓇ CosentyxⓇ In-market growth drivers²/base business Pipeline probabilized Core margin -40%+ by 2027 2028 Note: All figures reflecting Continuing Operations. 1. For forecasting purposes, we assume Entresto US LoE in 2025. 2. Including indication expansion. Leqvio - licensed from Alnylam Pharmaceuticals, Inc. Pelacarsen - licensed from lonis Pharmaceuticals, Inc. □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 22#23Content Click below to navigate through the document We continue to focus on material environmental, social and governance factors alongside our pursuit of sustainable shareholder value creation ↓ ↑ Company overview Financial review Conclusions Appendix References Value creation Innovation and access to medicines Future-proof pipeline addressing unmet need Broad access to medicines Risk mitigation Human Capital Environmental Ethical Sustainability Standards Enablers Diversity, Equity Climate Ethics & Inclusion Water Compliance Culture Governance, transparency, non-financial reporting Waste Human rights Right thing to do Creating sustainable social and economic impact ATMI - Access to Medicines Index. 1. Pharmaceuticals subindustry group. Copyright Morningstar Sustainalytics. All rights reserved. □ NOVARTIS | Reimagining Medicine. IMPACT Consistent industry-leading performance across priority ESG ratings #1 in Sustainalytics1 Leaders group in MSCI Industry leader group in ISS ESG Leadership group in ATMI AA in CDP climate and water ៩០៩០ Novartis Q4 Results | January 31, 2024 23#24↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix References Financial review and 2024 guidance Harry Kirsch Chief Financial Officer □ NOVARTIS Reimagining Medicine#25Content Click below to navigate through the document Company overview Financial review Novartis continues to deliver strong operational performance over a number of years... Continuing operations¹ performance, numbers restated post-Sandoz spin-off FINANCIAL PROFILE ↓ ↑ Conclusions Appendix References Net sales USDbn, % cc +7% CAGR +7% +10% +5% +4% +12% 35.2 Core Oplnc² USDbn, % cc +14% CAGR +12% +18% +10% +13% +20% 10.1 Core margin² % +990bps cc 36.0 35.1 33.9 32.4 30.6 28.7 2018 2019 2020 2021 2022 2023 2018 2019 2020 2021 2022 2023 2018 2019 2020 2021 2022 2023 USDbn 35.2 38.1 39.5 42.8 42.2 45.4 10.1 11.7 12.8 14.5 14.8 16.4 1. As defined on page 37 of the Condensed Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities. constant currencies are non-IFRS measures. Details regarding non-IFRS measures can be found starting on page 49 of the Condensed Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. 2. Core results and □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 25#26↓ Content Click below to navigate through the document ... and in 2023, met/exceeded our upgraded FY guidance ↑ Company overview Financial review Continuing operations¹ In cc Conclusions FINANCIAL PROFILE Appendix References FY guidance (Q3 earnings Oct 2023) Actual results FY 2023 vs. PY Prior guidance before upgrades (Q4 2022) Sales expected to grow high single-digit +10% Guidance as per Q4 2022 earnings Sales expected to grow low to mid single-digit Core operating income expected to grow mid to high-teens +18% Guidance as per Q4 2022 earnings Core operating income expected to grow mid to high single-digit 1. As defined on page 37 of the Condensed Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 49 of Condensed Financial Report. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 26#27Content Click below to navigate through the document Robust top and bottom-line growth during the quarter and FY FINANCIAL PROFILE ↓ ↑ Company overview Financial review Continuing operations¹ Q4 Change vs. PY FY Conclusions USD million 2023 2023 % USD % cc % USD Change vs. PY % cc Appendix Net sales 11,423 8 10 45,440 8 10 References Core operating income 3,821 5 13 16,372 11 18 Core margin 33.5% 1% pts 36.0% 2.4% pts Operating income 2,582 47 68 9,769 23 39 Net Income 2,638 101 130 8,572 42 62 Core EPS (USD) 1.53 10 16 6.47 18 25 EPS (USD) 1.29 108 140 4.13 49 70 Free cash flow 2,141 -38 13,160 9 Novartis Q4 Results | January 31, 2024 27 1. As defined on page 37 of the Condensed Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities. Core results and constant currencies are non-IFRS measures. Details regarding non-IFRS measures can be found starting on page 49 of the Condensed Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. □ NOVARTIS | Reimagining Medicine.#28↓ ↑ Content Click below to navigate through the document Continuing to create significant shareholder value Company overview Financial review Conclusions Appendix Investing in the business Investments in organic business R&D >USD 47bn, CAPEX >USD 6bn 2018-20231 References Value-creating bolt-ons >USD 33bn 2018-2023 Substantial cash generation Whilst also creating shareholder value via numerous strategic actions Jun 2018 Divested consumer health JV 1. Core R&D and CAPEX actuals. 2. In CHF. Apr 2019 Spun Alcon □ NOVARTIS Reimagining Medicine FINANCIAL PROFILE Returning capital to shareholders Consistently growing annual dividend² >USD 42bn of dividends 2018-2023 No rebasing post Alcon and Sandoz spin-off Share buybacks >USD 32bn 2018-2023 New USD 15bn SBB commenced in Jul 2023 Nov 2021 Exited Roche stake Oct 2023 Spun Sandoz Novartis Q4 Results | January 31, 2024 28#29Content Click below to navigate through the document Company overview Financial review Conclusions Appendix References For Novartis and Sandoz shareholders since October 3, 2023, USD 28.6bn (+13.9%) of value has been created Market capitalization growth since the Sandoz spin-off Total market capitalization 1,2 (in USD bn) Novartis Sandoz Day before spin-off Day of spin-off As of Jan 30, 2024 Sandoz spin-off highlights . Completed the separation of Sandoz to create an FINANCIAL PROFILE independent company by way of 100% spin-off (Oct 4, 2023) • Shares of Sandoz are listed on the SIX Swiss Exchange and traded OTC in the US ↓ ↑ +28.6 (+13.9%) +3.1 (+1.5%) 233.7 219.3 205.1 208.2 196.9 11.3 14.5 Novartis on Novartis and Sandoz Novartis and Sandoz October 3, 2023 on October 4, 2023 on January 30, 2024 . Novartis continues with its consistently growing annual dividend with no re-basing post the Sandoz spin-off 1. Market capitalization of Novartis on October 3, 2023 is based on closing share price and outstanding shares of 2,055,060,483 (as per October 3); market capitalization for Novartis and Sandoz on October 4, 2023 are based on opening share prices on October 4, outstanding shares of 2,055,060,483 for Novartis and 431,000,000 shares for Sandoz; market capitalization for Novartis and Sandoz on January 30, 2024 are based on closing share prices on January 30, outstanding shares as of December 31, 2023 of 2,044,033,986 for Novartis and 431,000,000 shares for Sandoz. 2. USD values based on USD/CHF exchange rates as per the respective days; source: Bloomberg. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 29#30↓ ↑ Content Click below to navigate through the document Company overview FINANCIAL PROFILE Novartis proposes 3.30 CHF/share¹ dividend at the AGM; 27th consecutive dividend increase (no rebasing post Sandoz spin-off) Financial review 4.0 CHF dividend USD dividend4 Conclusions 3.5 2023 proposal: CHF 3.30/USD 3.924 2022: CHF 3.20/USD 3.514 Appendix 3.0 References 2023 1996-2023 CAGR 2.5 Dividend yield 3.9%2 Dividend growth 3.1%³ CHF: 7.2% USD: 9.5%4 2.0 1.5 1.0 - 0.0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 0.5 3. In CHF. 1. Proposal to shareholders at the 2024 Annual General Meeting, taking place on March 5, 2024. 2. Based on the NOVN closing share price of CHF 84.87, as of December 29, 2023. 4. Historical dividends per share converted at historical exchange rates at the dividend payment dates as per Bloomberg; for 2023, translated into US dollars at the FX rate of CHF/USD of 1.189, as of December 31, 2023. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 30#31Content Click below to navigate through the document Novartis (continuing operations¹) 2024 full year guidance Expected, barring unforeseen events; growth vs. PY in cc ↓ ↑ Company overview Financial review Conclusions Appendix References FINANCIAL PROFILE Net sales expected to grow mid-single-digit Key assumptions Core operating income expected to grow high single-digit FY 2024 guidance on other financial KPIs . Core net financial result: Expenses expected to be around USD 0.6bn to 0.7bn Core tax rate: Expected to be around 16-16.5% ● No US EntrestoⓇ Gx launch in 2024 1. As defined on page 37 of the Condensed Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities. Core results and constant currencies are non-IFRS measures. Further details regarding non-IFRS measures can be found starting on page 49 of the Condensed Financial Report. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 31#32↓ ↑ Content Click below to navigate through the document Expected currency impact for Q1 and full year 2024 Company overview Financial review Conclusions Appendix References Currency impact vs. PY %pts, assuming late-January exchange rates prevail in 2024 FX impact on Net sales FX impact on Core operating income -1 -2 -2 -2 -3 -5 to -6 -7 -8 Q4 FY Q1 FY Q4 FY Q1 FY 2023 2024 2023 2024 Actual Simulation FINANCIAL PROFILE Q4 Core Oplnc FX impact includes app. -2%pts from the effect of mid Dec Argentina ARS devaluation¹ 1. Core results are non-IFRS measures as defined on page 49 of Condensed Financial Report. 2. IFRS requires for our Argentina subsidiary, as it operates in a hyperinflation economy, to translate for consolidation purposes their full year income statement to our USD presentation currency using the ARS closing rate, and not using the average exchange rate for the period. This results in the 9-months and the Q4 devaluation impact being recognized in Q4. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 32#33↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix References Conclusions Vas Narasimhan, M.D. Chief Executive Officer □ NOVARTIS Reimagining Medicine#34↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix References Very strong 2023: Double-digit growth for sales and Core Oplnc for the quarter and full year Met/exceeded all strategic, operational and innovation targets: Including successful Sandoz spin-off; 10 positive Ph3 readouts with significant sales potential Confident for 2024 and mid-term guidance of 5% cc sales CAGR 2023-28, -40%+ margin by 2027 □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 34#35↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations References Appendix □ NOVARTIS Reimagining Medicine#36Content Click below to navigate through the document Strong FY growth driven by performance from EntrestoⓇ, KesimptaⓇ, KisqaliⓇ and PluvictoⓇ ↓ ↑ Company overview Financial review FY sales Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations References GROWTH Sales Entresto sacubitril/valsartan USD million Growth vs. PY USD million USD growth @ Period Growth vs. PY сс 6,035 1,391 31% Kesimpta (ofatumumab) 2,171 1,079 99% 20 mg injection KISQALI 2,080 849 75% ribociclib "PLUVICTO™ Strong growth (+40% cc); 980 709 261% expected to SCEMBLIX® 413 264 179% (asciminib) 20 mg, 40mg tablets continue LEQVIO® 355 243 217% Cosentyx (secukinumab) ILARIS (canakinumab) 4,980 192 5% 1,355 222 22% istra miezione sottocutanes PROMACTA 2,269 181 10% (eltrombopag) JAKAVI® 1,720 159 12% ruxolitinib Tafinlar. Mekinist. 1,922 152 11% (dabrafenib) (trametinib) Constant currencies (cc) is a non-IFRS measure; explanation of non-IFRS measures can be found on page 49 of Condensed Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 36#37↓ Content Click below to navigate through the document Our pipeline projects at a glance ↑ Company overview INNOVATION Financial review Phase 1/2 Phase 3 Registration Total Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations References Oncology Solid tumors Hematology Immunology Neuroscience 25 12 3 40 18 6 3 27 7 6 0 13 17 10 1 28 5 5 0 10 Cardiovascular, Renal and Metabolic 6 10 0 16 Others (thereof IB&GH) 11 (7) 4 (3) 0 15 64 41 4 109 IB&GH: In-market Brands and Global Health. □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 37#38↓ ↑ Content Click below to navigate through the document Company overview Novartis pipeline in Phase 1 Oncology Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations References Code Name Solid tumors AAA603 177Lu-NeoB Mechanism AAA604 AAA604 AAA614 AAA614 AAA802 225AC-PSMA-R2 225AC-PSMA-617 AAA817 HRO761 HRO761 IAG933 IAG933 KFA115 KFA115 MGY825 MGY825 NZV930 NZV930 QEQ278 QEQ278 Hematology DFV890 DFV890 PIT565 PIT565 Radioligand therapy target GRPR Radioligand therapy target integrin beta-3/beta-5 Radioligand therapy target FAP Radioligand therapy target PSMA Radioligand therapy target PSMA Werner inhibitor Novel immunomodulatory Agent CD73 antagonist NKG2D/-L pathway modulator NLRP3 inhibitor YTB323 rapcabtagene autoleucel CD19 CAR-T Indication(s) Multiple solid tumors Breast cancer Glioblastoma multiforme Pancreatic cancer Solid tumors Prostate cancer Metastatic castration-resistant prostate cancer Solid tumors Mesothelioma Solid tumors NSCLC Solid tumors Solid tumors Low risk myelodysplastic syndrome B-cell malignancies Adult ALL Cardiovascular, Renal and Metabolic Code Name DFV890 DFV890 Mechanism NLRP3 inhibitor Indication(s) Cardiovascular risk reduction □ NOVARTIS Reimagining Medicine Neuroscience Code Name DFT383 DFT383 NIO752 NIO752 Mechanism CTNS gene delivery Tau antisense oligonucleotide Immunology INNOVATION 17 lead indications Lead indication Indication(s) Cystinosis pre/post kidney transplant Alzheimer's disease Progressive supranuclear palsy Code Name MHV370 MHV370 Mechanism Indication(s) TLR7, TLR8 Antagonist Systemic lupus erythematosus Others Code Name Mechanism Indication(s) IB&GH EDI048 EDI048 EYU688 EYU688 INE963 INE963 CpPI(4)K inhibitor NS4B inhibitor Cryptosporidiosis Dengue Malaria, uncomplicated Novartis Q4 Results | January 31, 2024 38#39↓ ↑ Content Click below to navigate through the document Company overview Novartis pipeline in Phase 2 Oncology Immunology INNOVATION 20 lead indications Lead indication Financial review Code Name Mechanism Solid tumors AAA601 Indication(s) LutatheraⓇ Radioligand therapy target SSTR GEPNET, pediatrics 1L ES-SCLC Glioblastoma KRAS inhibitor SHP2 inhibitor NSCLC and CRC (mono and/or combo) Solid tumors Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations JDQ443 opnurasib TNO155 TNO155 Hematology ABL001 ScemblixⓇ PHE885 BCR-ABL inhibitor durcabtagene autoleucel BCMA cell therapy PKC412 Rydapt® Multi-targeted kinase inhibitor YTB323 rapcabtagene autoleucel CD19 CAR-T References Neuroscience Code Name BLZ945 sotuletinib DLX3131 minzasolmin Mechanism CSF-1R inhibitor Alpha-synuclein misfolding inhibitor Chronic myeloid leukemia, 2L, pediatrics 4L multiple myeloma Acute myeloid leukemia, pediatrics 1L high-risk large B-cell lymphoma Indication(s) Amyotrophic lateral sclerosis Parkinson's disease Code Name CFZ533 iscalimab DFV890 DFV890 LNA043 LNA043 LOU064 remibrutinib LRX712 LRX712 MAS825 MAS825 MHV370 MHV370 NG1226 NG1226 QUC398 QUC398 RHH646 RHH646 VAY736 ianalumab Mechanism CD40 inhibitor NLRP3 inhibitor ANGPTL3 agonist BTK inhibitor TLR7, TLR8 Antagonist ADAMTS5 inhibitor BAFF-R inhibitor, ADCC- mediated B-cell depletor YTB323 rapcabtagene autoleucel CD19 CAR-T Indication(s) Sjögren's Osteoarthritis Familial cold auto-inflammatory syndrome Osteoarthritis Osteoarthritis (combos) Food allergy Hidradenitis suppurativa Osteoarthritis NLRC4-GOF indications Sjögren's Mixed connective tissue disease Tendinopathy Osteoarthritis Osteoarthritis Autoimmune hepatitis srSLE/LN Cardiovascular, Renal and Metabolic Code Name CFZ533 iscalimab Mechanism CD40 inhibitor CFB inhibitor LNP023 iptacopan TIN816 TIN816 XXB750 XXB750 ATP modulator NPR1 agonist 1. DLX313 is the Novartis compound code for UCB0599. Indication(s) Lupus nephritis Lupus nephritis Acute kidney injury Hypertension Heart failure □ NOVARTIS Reimagining Medicine Others Name Code IB&GH KAE609 cipargamin Mechanism Indication(s) LXE408 LXE408 SEG101 AdakveoⓇ Others CMK389 CMK389 LNP023 iptacopan LTP001 LTP001 PfATP4 inhibitor Proteasome inhibitor P-selectin inhibitor IL-18 inhibitor CFB inhibitor SMURF1 inhibitor Malaria, severe Malaria, uncomplicated Visceral leishmaniasis Sickle cell disease, pediatrics Pulmonary sarcoidosis ¡AMD Pulmonary arterial hypertension Idiopathic pulmonary fibrosis Novartis Q4 Results | January 31, 2024 39#40↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Novartis pipeline in Phase 3 Oncology AAA617 Code Name Solid tumors PluvictoⓇ Mechanism INNOVATION 8 lead indications Lead indication CGRPR antagonist S1P1,5 receptor modulator BTK inhibitor Indication(s) Migraine, pediatrics Multiple sclerosis, pediatrics Multiple sclerosis SMN1 gene replacement therapy SMA IT administration CD20 Antagonist Multiple sclerosis, pediatrics Indication(s) Radioligand therapy target PSMA Metastatic castration-resistant prostate cancer (mCRPC), pre-taxane Metastatic hormone sensitive prostate cancer (mHSPC) Oligometastatic prostate cancer Radioligand therapy target SSTR Gastroenteropancreatic neuroendocrine tumors, 1st line in G2/3 PI3K-alpha inhibitor KRAS inhibitor tumors (GEP-NET 1L G3) Lymphatic malformations 2/3L Non-small cell lung cancer Neuroscience Code Name AMG334 AimovigⓇ BAF312 MayzentⓇ LOU064 remibrutinib OAV101 AVXS-101 OMB157 KesimptaⓇ Immunology Mechanism Code Name AIN457 CosentyxⓇ Mechanism IL17A inhibitor LOU064 remibrutinib BTK inhibitor Atypical hemolytic uraemic syndrome 1L Immune Thrombocytopenia 2L Immune Thrombocytopenia QGE031 ligelizumab VAY736 ianalumab IgE inhibitor warm Autoimmune Hemolytic Anemia BAFF-R inhibitor, ADCC- mediated B-cell depletor Indication(s) Giant cell arteritis Polymyalgia rheumatica Rotator cuff tendinopathy Chronic spontaneous urticaria Chronic spontaneous urticaria, pediatrics CINDU Food allergy Sjögren's Lupus Nephritis Systemic lupus erythematosus Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations References AAA6011 LutatheraⓇ BYL719 PiqrayⓇ, Vijoyce® JDQ443 opnurasib Hematology ABL001 ScemblixⓇ® ETB115 PromactaⓇ LNP023 iptacopan VAY736 ianalumab BCR-ABL inhibitor Thrombopoietin receptor (TPO-R) agonist CFB inhibitor BAFF-R inhibitor, ADCC- mediated B-cell depletor Chronic myeloid leukemia, 1st line Radiation sickness syndrome Cardiovascular, Renal and Metabolic Code Name EXV811 atrasentan FUB523 zigakibart KJX839 Leqvio® Mechanism ETA receptor antagonist Anti-APRIL siRNA (regulation of LDL-C) LNP023 iptacopan CFB inhibitor Indication(s) IgA nephropathy IgA nephropathy CVRR-LDLC Primary prevention Hyperlipidemia, pediatrics IgA nephropathy TQJ230 pelacarsen 1. 177 Lu-dotatate in US. C3 glomerulopathy C3 glomerulopathy, pediatrics IC-MPGN Others Code Name Mechanism IB&GH Indication(s) COA566 Coartem® KLU156 Ganaplacide + lumefantrine QMF149 AtecturaⓇ Others PGH-1 (artemisinin combination therapy) Non-artemisinin plasmodium falciparum inhibitor LABA + ICS Malaria, uncomplicated (<5kg patients) Malaria, uncomplicated Asthma, pediatrics ASO targeting Lp(a) Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a) (CVRR-Lp(a)) RTH258 BeovuⓇ VEGF Inhibitor Diabetic retinopathy □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 40#41↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations References Novartis pipeline in registration Oncology Code Name Solid tumors LEE011 KisqaliⓇ INC424 JakaviⓇ Immunology Mechanism Indication(s) CDK4/6 Inhibitor JAK1/2 inhibitor HR+/HER2- BC (adj) Acute GVHD, pediatrics Chronic GVHD, pediatrics Code Name IGE025 XolairⓇ Mechanism IgE inhibitor Indication(s) Food Allergy INNOVATION □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 41#42↓ ↑ Content Click below to navigate through the document Novartis submission schedule New Molecular Entities: Lead and supplementary indications Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations References Lead Supplementary 2024 atrasentan EXV811 IgAN remibrutinib LOU064 CSU iptacopan LNP023 C3G iptacopan LNP023 IgAN ۱۲۳۴ 2025 pelacarsen TQJ230 CVRR-Lp(a) INNOVATION CRM Immunology Neuroscience Oncology Non-core TA project 2026 ≥2027 ianalumab VAY736 2L Immune Thrombocytopenia XXB750 Hypertension ۱۳ zigakibart It's 177Lu-NeoB AAA603 Multiple Solid Tumors iscalimab CFZ533 Sjögren's syndrome ligelizumab QGE031 Food allergy LNA043 Knee osteoarthritis opnurasib JDQ443 NSCLC (mono/combo) rapcabtagene autoleucel YTB323 High-risk large B-cell lymphoma FUB523 IgAN ganaplacide/lumefantrine KLU156 Malaria uncomplicated cipargamin KAE609 Malaria severe LXE408 Visceral leishmaniasis ianalumab VAY736 1L Immune Thrombocytopenia ianalumab VAY736 WAIHA ianalumab VAY736 AIH ianalumab VAY736 SLE iptacopan LNP023 aHUS ianalumab VAY736 Lupus Nephritis iptacopan LNP023 IC-MPGN rapcabtagene autoleucel YTB323 srSLE/LN remibrutinib LOU064 Multiple sclerosis remibrutinib LOU064 CINDU ianalumab VAY736 Sjögren's syndrome □ NOVARTIS Reimagining Medicine | cipargamin KAE609 Malaria uncomplicated Novartis Q4 Results | January 31, 2024 42#43↓ ↑ Content Click below to navigate through the document Novartis submission schedule Supplementary indications for existing brands Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations References Existing brands INNOVATION CRM Immunology Neuroscience Oncology Non-core TA project 2024 LutatheraⓇ 177 Lu-oxodotreotide¹ GEP-NET 1L G2/G3 (EU only) PluvictoⓇ AAA617 mCRPC, Pre-taxane ScemblixⓇ asciminib CML 1L 2025 Cosentyx® secukinumab, AIN457 GCA LeqvioⓇ KJX839 Ped Hyperlipidemia PluvictoⓇ AAA617 MHSPC2 ZolgensmaⓇ AVXS-101 OAV101 SMA IT 2026 Cosentyx® Secukinumab Polymyalgia rheumatica RydaptⓇ midostaurin Acute myeloid leukemia, pediatrics ScemblixⓇ asciminib CML, 2L, pediatrics AimovigⓇ Erenumab Pediatric Migraine Cosentyx® Secukinumab Tendinopathy KesimptaⓇ 3 Ofatumumab Multiple sclerosis, pediatrics LeqvioⓇ KJX839 CVRR-LDLC ≥2027 LeqvioⓇ KJX839 Primary prevention Mayzent® 2 siponimod Multiple sclerosis, pediatrics Piqray/Vijoice® BYL719 Lymphatic malformations PluvictoⓇ AAA617 Oligometastatic PC CoartemⓇ artemether + lumefantrine, COA566 Malaria uncompl., formula for <5kg 1. 177 Lu-dotatate in US. BeovuⓇ brolucizumab, RTH258 Diabetic retinopathy Adakveo SEG101 Sickle cell disease, pediatrics 2. Event-driven trial endpoint. 3. Kesimpta and Mayzent: Pediatric trial in multiple sclerosis run in conjunction (NEOS). □ NOVARTIS | Reimagining Medicine. AtecturaⓇ indacaterol + mometasone, QMF149 Asthma, pediatrics PromactaⓇ eltrombopag, ETB115 Radiation sickness syndrome Novartis Q4 Results | January 31, 2024 43#44Content Click below to navigate through the document Net debt increased by USD 3.0bn mainly due to dividends and share buybacks, partly offset by FCF FINANCIAL PROFILE ↓ ↑ Company overview Financial review USDbn Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Abbreviations References -7.2 -7.3 -8.6 Dec 31, 2022 Dividends Treasury share transactions, net -3.0 -3.3 M&A/Intangible assets transactions, net 1 Reflects USD 0.7bn cash and cash equivalents, and USD 3.7bn of financial debts of Sandoz at the time of the spin-off. □ NOVARTIS | Reimagining Medicine. -10.2 3.0 13.2 Free Cash Flow Net debt Sandoz 1 Dec 31, 2023 Novartis Q4 Results | January 31, 2024 44#45↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations References 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 □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 45#46↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations Cardiovascular, Renal and Metabolic References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 46#47↓ ↑ Content Click below to navigate through the document atrasentan - ETA receptor antagonist Company overview Financial review Conclusions NCT04573478 ALIGN (CHK01-01) Indication Phase Patients Outcome Measures Arms Intervention Target Patients IgA nephropathy Phase 3 380 Change in proteinuria Time Frame: Up to Week 24 or approximately 6 months Annualized total estimated Glomerular Filtration Rate (eGFR) slope estimated over 24 months Arm 1 Experimental: Atrasentan, once daily oral administration of 0.75 mg atrasentan for 132 weeks Arm 2 Placebo comparator: Placebo once daily oral administration of placebo for 132 weeks Patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function 2023 (primary endpoint for US initial submission) 2026 (24 months) Readout Milestone(s) Publication TBD Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations Primary References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 47#48↓ ↑ Content Click below to navigate through the document iptacopan - CFB inhibitor Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations References NCT04578834 APPLAUSE-IgAN (CLNP023A2301) iptacopan - CFB inhibitor NCT05755386 APPARENT (CLNP023B12302) Indication Phase Immune complex-mediated membranoproliferative glomerulonephritis Phase 3 Indication IgA nephropathy Phase Phase 3 Patients 450 Patients 68 Primary Outcome Ratio to baseline in urine protein to creatinine ratio (sampled from 24h urine collection) at 9 months Measures Annualized total estimated Glomerular Filtration Rate (eGFR) slope estimated over 24 months Primary Outcome Measures Target Patients Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months. [ Time Frame: 6 months (double-blind) ] To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months. Log-transformed ratio to baseline in UPCR at the 12-month visit (both study treatment arms) [ Time Frame: 12 months] To evaluate the effect of iptacopan on proteinuria at 12 months. Log-transformed ratio to 6-month visit in UPCR at the 12-month visit in the placebo arm. [ Time Frame: 12 months ] To evaluate the effect of iptacopan on proteinuria at 12 months. Arm 1 experimental: Drug: iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d) Arm 2 placebo to iptacopan 200mg b.i.d. (both on top of SoC) Patients (adults and adolescents aged 12-17 years) with idiopathic IC-MPGN Arms Arm 1 LNP023 200mg BID Intervention Arm 2 - Placebo BID Target Patients Primary IgA Nephropathy patients Readout Milestone(s) Publication 2023 (primary endpoint for US initial submission, 9 months UPCR) 2025 (24 months) Arms Intervention TBD □ NOVARTIS Reimagining Medicine Readout Milestone(s) Publication 2026 Vivarelli M, et al., Kidney International Reports (2023), Iptacopan in idiopathic immune complex-mediated membranoproliferative glomerulonephritis: Protocol of the APPARENT multicenter, randomized Phase III study Novartis Q4 Results | January 31, 2024 48#49↓ ↑ Content Click below to navigate through the document iptacopan - CFB inhibitor Company overview Financial review Conclusions Appendix NCT03955445 (CLNP023B12001B) iptacopan - CFB inhibitor NCT04817618 APPEAR-C3G (CLNP023B12301) C3 glomerulopathy Phase 3 Log-transformed ratio to baseline in UPCR (sampled from a 24 hour urine collection) Experimental: iptacopan 200mg b.i.d. Placebo Comparator: Placebo to iptacopan 200mg b.i.d. Patients with native C3G 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 83 Arms Intervention 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 Primary Outcome Measures Arms Intervention Target Patients Target Patients Readout Patients with C3 glomerulopathy 2025 Readout Milestone(s) 2023 Primary Innovation: Pipeline overview Outcome Measures Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations References Milestone(s) Publication TBD Publication TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 49#50↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations References LeqvioⓇ - siRNA (regulation of LDL-C) LeqvioⓇ - siRNA (regulation of LDL-C) NCT03705234 ORION-4 (CKJX839B12301) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients NCT05030428 VICTORION-2P (CKJX839B12302) Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH) Indication Phase 3 16124 A composite of major adverse cardiovascular events, defined as: Coronary heart disease (CHD) death; Myocardial infarction; Fatal or non-fatal ischaemic stroke; or Urgent coronary revascularization procedure Arm 1: every 6 months 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 Phase Patients Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Publication Secondary prevention of cardiovascular events in patients with elevated levels of LDL-C Phase 3 16970 1. Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events) Arm 1: Experimental Inclisiran sodium, Subcutaneous injection Arm 2: Placebo Comparator, Placebo Subcutaneous injection Participants with established cardiovascular disease (CVD) 2027 TBD Readout Milestone(s) 2026 Publication TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 50#51↓ ↑ Content LeqvioⓇ - siRNA (regulation of LDL-C) Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations References NCT04652726 ORION-16 (CKJX839C12301) Hyperlipidemia, pediatrics Indication Phase Phase 3 Patients 141 Primary Outcome Measures Arms Intervention Target Patients 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 heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C) Readout Milestone(s) 2025 Publication TBD □ NOVARTIS Reimagining Medicine Leqvio® - siRNA (regulation of LDL-C) NCT04659863 ORION-13 (CKJX839C12302) Hyperlipidemia, pediatrics Indication Phase Phase 3 Patients 13 Primary Outcome Measures Arms Intervention Target Patients 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) Readout Milestone(s) 2025 Publication TBD Novartis Q4 Results | January 31, 2024 51#52↓ ↑ Content Click below to navigate through the document LeqvioⓇ - siRNA (regulation of LDL-C) LeqvioⓇ - siRNA (regulation of LDL-C) Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations References NCT05739383 VICTORION-1P (CKJX839D12302) CVRR (Primary prevention) Phase 3 Indication Phase Patients 14000 Primary Outcome Measures Arms Intervention Target Patients NCT05763875 V-Mono (CKJX839D12304) Indication Phase CVRR (Primary prevention) Phase 3 Patients 300 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 2029 Primary Outcome Measures Arms Intervention Target Patients 1.Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to day 150 compared with placebo [ Time Frame: Baseline, Day 150 ] 2. Percentage change in LDL-C from baseline to day 150 compared with ezetimibe [ Time Frame: Baseline, Day 150 ] Arm 1 Experimental: Inclisiran s.c and Placebo p.o. Arm 2 Active Comparator: Placebo s.c. and Ezetimibe p.o. Arm 3 Placebo Comparator: Placebo s.c. and Placebo p.o. Adult patients with primary hypercholesterolemia not receiving any lipid-lowering therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk of less than 7. Readout Milestone(s) Publication TBD □ NOVARTIS Reimagining Medicine Readout Milestone(s) 2024 Publication TBD Novartis Q4 Results | January 31, 2024 52#53↓ ↑ Content Click below to navigate through the document pelacarsen - Antisense oligonucleotide (ASO) targeting Lp(a) Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations References NCT04023552 Lp(a)HORIZON (CTQJ230A12301) Indication Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein(a) Phase Phase 3 Patients 8323 Primary Outcome Measures Arms Intervention Target Patients 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 Readout Milestone(s) 2025 Publication TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 53#54↓ ↑ Content Click below to navigate through the document XXB750 - NPR1 agonist Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations References Indication NCT05562934 (CXXB750B12201) Hypertension Phase Phase 2b Patients 170 Primary Outcome Change from baseline in mean 24hr ambulatory systolic blood pressure at week 12 Measures 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 Target Patients Resistant Hypertension Patients Readout Milestone(s) 2024 Publication TBD □ NOVARTIS Reimagining Medicine XXB750 - NPR1 agonist NCT06142383 (CXXB750A12201) Indication Phase Heart failure Phase 2 Change in log NT-proBNP from baseline to Week 16 [ Time Frame: Baseline to Week 16] Patients 720 Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Arm 1 Placebo Comparator Arm 2 Experimental: XXB750 Low Dose Arm 3 Experimental: XXB750 Medium Dose Arm 4 Experimental: XXB750 High Dose Arm 5 Active Comparator: Sacubitril/valsartan, open label tablet Patients with heart failure 2026 Publication TBD Novartis Q4 Results | January 31, 2024 54#55↓ ↑ Content Click below to navigate through the document zigakibart - Anti-APRIL Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials > Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other Global Health Abbreviations References NCT05852938 BEYOND (CFUB523A12301) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients IgA nephropathy Phase 3 292 Change in proteinuria [ Time Frame: 40 weeks or approximately 9 months ] Arm 1 Experimental: BION-1301 (Zigakibart) 600mg subcutaneous administration every 2 weeks for 104 weeks Arm 2 Placebo Comparator: Placebo subcutaneous administration every 2 weeks for 104 weeks Adults with IgA Nephropathy Readout Milestone(s) Publication 2026 TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 55#56↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic > Immunology Neuroscience Oncology Other Global Health Abbreviations Immunology References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 56#57↓ ↑ Content Click below to navigate through the document Cosentyx® - IL-17A inhibitor Company overview Financial review Conclusions NCT05767034 REPLENISH (CAIN457C22301) Polymyalgia rheumatica Indication Phase Patients 360 Phase 3 Proportion of participants achieving sustained remission Cosentyx® - IL-17A inhibitor NCT04930094 GCAPTAIN (CAIN457R12301) Indication Giant cell arteritis Phase 3 Number of participants with sustained remission Phase Patients 348 Primary Outcome Intervention Arm 1 Experimental: Secukinumab 300 mg, randomized in 1:1:1 ratio every 4 weeks 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 Target Patients Readout Milestone(s) Adult patients with PMR who have recently relapsed 2025 Publication TBD Measures Arms Intervention Target Patients Readout Milestone(s) Publication Experimental: Secukinumab 300 mg Placebo Comparator: Placebo Patients with Giant Cell Arteritis (GCA) Primary 2025 Final 2026 TBD Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic > Immunology Neuroscience Oncology Other Global Health Abbreviations Primary Outcome Measures Arms References □ NOVARTIS Reimagining Medicine | Novartis Q4 Results | January 31, 2024 57#58↓ ↑ Content Click below to navigate through the document Cosentyx® - IL-17A inhibitor Company overview Financial review Conclusions Cosentyx® - IL-17A inhibitor Indication NCT05722522 (CAIN457012301) Rotator cuff tendinopathy Phase Phase 3 NCT05758415 (CAIN457012302) Indication Phase Rotator cuff tendinopathy Phase 3 Patients 234 Patients 234 Outcome Measures 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 Primary Outcome Measures Arms Intervention Arm 1: Secukinumab 2 X 150 mg / 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio Target Patients Arm 2: Placebo 2X 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio Patients with moderate-severe Rotator Cuff Tendinopathy Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic > Immunology Neuroscience Oncology Other Global Health Abbreviations Primary References Readout Milestone(s) 2025 Publication TBD □ NOVARTIS Reimagining Medicine | Arms Intervention Target Patients Readout Milestone(s) 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 2025 Publication TBD Novartis Q4 Results | January 31, 2024 58#59↓ Content Click below to navigate through the document ianalumab - BAFF-R inhibitor ianalumab - BAFF-R inhibitor ↑ Financial review Conclusions NCT03217422 AMBER (CVAY736B2201) Autoimmune hepatitis Phase 2 Indication Phase Patients 68 Alanine aminotransferase (ALT) normalization VAY736 Placebo control with conversion to active VAY736 Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic > Immunology Neuroscience Oncology Other Global Health Abbreviations Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Publication 2024 TBD Autoimmune hepatitis patients with incomplete response or intolerant to standard treatment of care NCT05126277 SIRIUS-LN (CVAY736K12301) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Publication Lupus Nephritis Phase 3 420 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 Primary 2027 TBD Company overview References □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 59#60↓ ↑ Content Click below to navigate through the document ianalumab - BAFF-R inhibitor Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic > Immunology Neuroscience Oncology Other Global Health Abbreviations References NCT05349214 NEPTUNUS-2 (CVAY736A2302) Sjögren's syndrome Indication Phase Phase 3 Patients 489 Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Arm 1: Experimental - ianalumab exposure level 1 Arm 2: Experimental - ianalumab exposure level 2 Arm 3: Placebo comparator Patients with active Sjogren's syndrome Primary 2026 Publication TBD ianalumab - BAFF-R inhibitor NCT05350072 NEPTUNUS-1 (CVAY736A2301) Sjögren's syndrome Phase 3 Indication Phase Patients 268 Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Publication Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Arm 1: Experimental - ianalumab Arm 2: Placebo comparator Patients with active Sjogren's syndrome Primary 2026 TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 60#61↓ ↑ Content Click below to navigate through the document ianalumab - BAFF-R inhibitor Company overview Financial review Conclusions NCT05639114 SIRIUS-SLE 1 (CVAY736F12301) Systemic lupus erythematosus Indication Phase Phase 3 Patients 406 Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic > Immunology Neuroscience Oncology Other Global Health Abbreviations 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 Target Patients Readout Milestone(s) Experimental: lanalumab s.c. quarterly Placebo Comparator: Placebo s.c. monthly Patients with active systemic lupus erythematosus (SLE) 2027 Publication TBD References ianalumab - BAFF-R inhibitor NCT05624749 SIRIUS-SLE 2 (CVAY736F12302) Systemic lupus erythematosus Phase 3 Indication Phase Patients 280 Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) [ Time Frame: Week 60 ] Experimental: ianalumab s.c. monthly Placebo Comparator: placebo s.c. monthly Patients with active systemic lupus erythematosus (SLE) 2027 Publication TBD □ NOVARTIS Reimagining Medicine | Novartis Q4 Results | January 31, 2024 61#62↓ ↑ Content Click below to navigate through the document LNA043 - ANGPTL3 agonist Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic > Immunology Neuroscience Oncology Other Global Health Abbreviations References NCT04864392 ONWARDS (CLNA043A12202) Knee osteoarthritis Indication Phase Phase 2 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 □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 62#63↓ ↑ Content Click below to navigate through the document remibrutinib - BTK inhibitor Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic > Immunology Neuroscience Oncology Other Global Health Abbreviations References NCT05030311 REMIX-1 (CLOU064A2301) Chronic spontaneous urticaria Indication Phase Phase 3 Patients 470 Primary Outcome Measures Arms Intervention Target Patients Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint) Arm 1: LOU064 (blinded) LOU064 (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2) Arm 2: LOU064 placebo (blinded) LOU064 placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open- label) taken orally for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2) Adult Chronic Spontaneous Urticaria (CSU) patients inadequately controlled by H1-antihistamines Readout Milestone(s) 2024 (Final) Publication TBD □ NOVARTIS Reimagining Medicine remibrutinib - BTK inhibitor NCT05032157 REMIX-2 (CLOU064A2302) Indication Phase Chronic spontaneous urticaria Phase 3 Patients 455 Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) 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) Publication TBD Novartis Q4 Results | January 31, 2024 63#64↓ ↑ Content Click below to navigate through the document remibrutinib - BTK inhibitor Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic > Immunology Neuroscience Oncology Other Global Health Abbreviations References NCT05976243 (CLOU064M12301) Chronic inducible urticaria Phase 3 Indication Phase Patients 348 Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) 1. Proportion of participants with complete response in Total Fric Score; symptomatic dermographism [ Time Frame: Week 12] 2. Proportion of participants with complete response in critical temperature threshold; cold urticaria [ Time Frame: Week 12] 3. Proportion of participants with itch numerical rating scale =0; cholinergic urticaria [ Time Frame: Week 12] All arms oral, twice daily: Arm 1 Experimental Remibrutinib, symptomatic dermographism group Arm 2 Placebo symptomatic dermographism group Arm 3 Experimental Remibrutinib, cold urticaria group Arm 4 Placebo cold urticaria group Arm 5 Experimental Remibrutinib, cholinergic urticaria group Arm 6 Placebo cholinergic urticaria group Adults suffering from CINDU inadequately controlled by H1-antihistamines 2026 Publication TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 64#65↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology > Neuroscience Oncology Other Global Health Abbreviations Neuroscience References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 65#66↓ ↑ Content Click below to navigate through the document MayzentⓇ - S1P1,5 receptor modulator Company overview Financial review Conclusions NCT04926818 NEOS (CBAF312D2301) Multiple sclerosis, pediatrics Phase 3 Indication Phase Patients 180 Annualized relapse rate (ARR) in target pediatric participants Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology > Neuroscience Oncology Other Global Health Abbreviations Primary Outcome Measures Arms Intervention Target Patients References 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 □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 66#67↓ ↑ Content Click below to navigate through the document remibrutinib - BTK inhibitor Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology > Neuroscience Oncology Other Global Health Abbreviations References remibrutinib - BTK inhibitor NCT05147220 REMODEL-1 (CLOU064C12301) Multiple sclerosis Indication Phase Phase 3 Patients 800 Primary Outcome Measures Arms Intervention Target Patients Annualized relapse rate (ARR) of confirmed relapses [Core Part]. ARR is the average number of confirmed MS relapses in a year 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 Readout Milestone(s) Publication TBD NCT05156281 REMODEL-2 (CLOU064C12302) Indication Multiple sclerosis Phase Phase 3 Patients 800 Primary Outcome Measures Arms Intervention Annualized relapse rate (ARR) of confirmed relapses Target Patients Readout Milestone(s) Publication 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 TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 67#68Content Click below to navigate through the document ZolgensmaⓇ - SMN1 gene replacement therapy ZolgensmaⓇ - SMN1 gene replacement therapy ↓ ↑ Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology > Neuroscience Oncology Other Global Health Abbreviations References NCT05089656 STEER (COAV101B12301) Spinal muscular atrophy (IT administration) Phase 3 Indication Phase Patients 125 Primary Outcome Measures Arms Intervention Target Patients 1. Change from baseline in Hammersmith functional motor scale - Expanded (HFMSE) total score at the end of follow-up period 1 in treated patients compared to sham controls in the ≥ 2 to < 18 years age group Arm 1: Experimental OAV101. Administered as a single, one-time intrathecal dose Arm 2: Sham Comparator: Sham control. A skin prick in the lumbar region without any medication. Patients Type 2 Spinal Muscular Atrophy (SMA) who are ≥ 2 to < 18 years of age, treatment naive, sitting, and never ambulatory NCT05386680 STRENGTH (COAV101B12302) Spinal muscular atrophy (IT administration) Phase 3B Indication Phase Patients 28 Primary Outcome Measures Arms Intervention Target Patients Number and percentage of participants reporting AEs, related AES, SAES, and AESIS [ Time Frame: 52 weeks ] Experimental: OAV-101 Single intrathecal administration of OAV101 at a dose of 1.2 x 10^14 vector genomes Participants with SMA who discontinued treatment With Nusinersen or Risdiplam (STRENGTH) Readout Milestone(s) Publication 2024 TBD □ NOVARTIS Reimagining Medicine Readout Milestone(s) 2024 Publication TBD Novartis Q4 Results | January 31, 2024 68#69↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations Oncology References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 69#70Content Click below to navigate through the document ianalumab - BAFF-R inhibitor ianalumab - BAFF-R inhibitor ↓ ↑ Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations References NCT05653349 VAYHIT1 (CVAY736112301) Indication Phase Patients Primary Outcome Measures Arms Intervention 1L Immune Thrombocytopenia Phase 3 225 Time from randomization to treatment failure (TTF) NCT05653219 VAYHIT2 (CVAY736Q12301) Indication Phase 2L Immune Thrombocytopenia Phase 3 Time from randomization to treatment failure (TTF) Patients 150 Primary Outcome Measures Arms 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) Target Patients Readout Milestone(s) Adult patients with primary ITP 2025 Publication TBD Target Patients Readout Milestone(s) Publication 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. 2025 TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 70#71↓ ↑ Content Click below to navigate through the document ianalumab - BAFF-R inhibitor Company overview Financial review Conclusions NCT05648968 VAYHIA (CVAY736012301) Warm autoimmune hemolytic anemia Phase 3 Indication Phase Patients 90 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 Comparator (intravenously) Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations Primary Outcome Measures Arms Intervention Readout Milestone(s) 2026 Publication TBD Target Patients Previously treated patients with warm Autoimmune Hemolytic Anemia References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 71#72↓ Content Click below to navigate through the document iptacopan - CFB inhibitor ↑ Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations NCT04889430 APPELHUS (CLNP023F12301) Atypical haemolytic uraemic syndrome Phase 3 Indication Phase 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) 2026 Publication TBD References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 72#73↓ ↑ Content Click below to navigate through the document opnurasib - KRAS inhibitor Company overview Financial review Conclusions NCT05132075 KontRASt-02 (CJDQ443B12301) Non-small cell lung cancer, 2/3L Indication Phase Phase 3 Patients 360 Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations Primary Outcome Measures Arms Intervention Target Patients References Progression free survival (PFS) 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) 2025 Publication NA □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 73#74Content Click below to navigate through the document PluvictoⓇ - Radioligand therapy target PSMA PluvictoⓇ - Radioligand therapy target PSMA ↓ ↑ Company overview Financial review Conclusions NCT04689828 PSMAfore (CAAA617B12302) Metastatic castration-resistant prostate cancer, pre-taxane Indication Phase Phase 3 Patients 450 Radiographic Progression Free Survival (rPFS) NCT04720157 PSMAddition (CAAA617C12301) Metastatic hormone sensitive prostate cancer Radiographic Progression Free Survival (rPFS) Indication Phase Phase 3 Patients 1126 Primary Outcome Measures 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) Final Analysis: 2025 Readout Milestone(s) Publication H2 2023 Target Patients Readout Milestone(s) Arm 1: 177 Lu-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) Primary Analysis: 2025 Publication TBD Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations Primary Outcome Measures Arms References □ NOVARTIS Reimagining Medicine | Novartis Q4 Results | January 31, 2024 74#75↓ ↑ Content Click below to navigate through the document RydaptⓇ - Multi-targeted kinase inhibitor Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations References NCT03591510 (CPKC412A2218) Acute myeloid leukemia, pediatrics Indication Phase Phase 2 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 □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 75#76↓ ↑ Content Click below to navigate through the document ScemblixⓇ - BCR-ABL inhibitor Company overview NCT04971226 ASC4FIRST (CABL001J12301) Chronic myeloid leukemia, 1st line Phase 3 Major Molecular Response (MMR) at week 48 Arm 1: asciminib 80 mg QD Arm 2: Investigator selected TKI including one of the below treatments: - Imatinib 400 mg QD Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations Indication Phase Patients 402 Primary Outcome Measures Arms Intervention Target Patients References - Nilotinib 300 mg BID - Dasatinib 100 mg QD - Bosutinib 400 mg QD Patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase Readout Milestone(s) 2024 (actual) Publication TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 76#77↓ ↑ Content Click below to navigate through the document TNO155 - SHP2 inhibitor Company overview Financial review Conclusions NCT03114319 (CTNO155X2101) Solid tumors (single agent) Phase 1 Indication Phase Patients 255 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 Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Publication 2025 TBD References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 77#78↓ ↑ Content Click below to navigate through the document VijoiceⓇ - PI3Ki Company overview NCT05948943 EPIK-L1 (CBYL719P12201) Indication Financial review Phase Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations Patients Primary Outcome Measures Arms Intervention Lymphatic Malformation Phase 2/3 230 Stage 2: Radiological response rate at Week 24 of Stage 2 (adult and pediatric (6 - 17 years of age) participants) Time Frame: Baseline, Week 24 Arm 1: Experimental. Adult participants, alpelisib dose 1 (Stage 1) Arm 2: Experimental. Adult participants, alpelisib dose 2 (Stage 1) Arm 3: Experimental. Pediatric participants (6-17 years of age), alpelisib dose 2 (Stage 1) Arm 4: Experimental. Pediatric participants (6-17 years of age), alpelisib dose 3 (Stage 1) Arm 5: Experimental. Adult participants, alpelisib (Stage 2) Arm 6: Placebo comparator. Adult participants, placebo (Stage 2) Arm 7: Experimental. Pediatric participants (6-17 years of age), alpelisib (Stage 2) Arm 8: Placebo Comparator. Pediatric participants (6-17 years of age), placebo (Stage 2) Arm 9: Experimental. Pediatric participants (2-5 years of age), alpelisib (Stage 2) Pediatric and adult patients with lymphatic malformations associated with a PIK3CA mutation References Target Patients Readout 2030 Milestone(s) Publication TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 78#79↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology > Other Global Health Abbreviations Other References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 79#80↓ ↑ Content Click below to navigate through the document BeovuⓇ - VEGF Inhibitor Company overview Financial review Conclusions NCT04278417 CONDOR (CRTH258D2301) Diabetic retinopathy Phase 3 Indication Phase Patients 694 Change from Baseline in BCVA 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 Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology > Other Global Health Abbreviations Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) 2024 Publication TBD References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 80#81↓ ↑ Content Click below to navigate through the document Company overview Financial review Conclusions Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other > Global Health Abbreviations Global Health References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 81#82↓ ↑ Content Click below to navigate through the document cipargamin - PfATP4 inhibitor Company overview Financial review Conclusions NCT04675931 KARISMA (CKAE609B12201) Malaria severe Phase 2 Indication Phase Patients 252 Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other > Global Health Abbreviations Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) 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 2025 References Publication TBD □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 82#83Content Click below to navigate through the document CoartemⓇ - PGH-1 (artemisinin combination therapy) ↓ ↑ Company overview Financial review Conclusions NCT04300309 CALINA (CCOA566B2307) Malaria, uncomplicated (<5kg patients) Phase 3 Indication Phase Patients 44 Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other > Global Health Abbreviations Primary Outcome Measures Arms Intervention Target Patients Artemether Cmax 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 (actual) 2024 (final) Readout Milestone(s) Publication TBD References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 83#84↑ Content Click below to navigate through the document ganaplacide/lumefantrine - Non-artemisinin plasmodium falciparum inhibitor ↓ Company overview Financial review Conclusions NCT05842954 KALUMA (CKLU156A12301) Indication Phase Patients Malaria, uncomplicated Phase 3 1500 PCR-corrected adequate clinical and parasitological response (ACPR) at day 29 Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience Oncology Other > Global Health Abbreviations Primary Outcome Measures Arms Intervention Arm 1 experimental: KLU156 oral; 400/480 mg is the dose for patients with a bodyweight ≥ 35kg. Patients < 35kg will take a fraction of the dose according to weight group as defined in the protocol. Arm 2 active comparator: Coartem, oral, dosing will be selected based on patient's body weight as per product's label. Adults and children ≥ 5 kg Body Weight with uncomplicated P. Falciparum Malaria Target Patients Readout Milestone(s) 2025 Publication TBD References □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 84#85↓ ↑ Content Click below to navigate through the document Abbreviations Company overview ΑΙ АІН aHUS Financial review ALL ALS Conclusions AML Auto-injector Autoimmune hepatitis atypical Hemolytic Uremic Syndrome Acute lymphoblastic leukemia Amyotrophic lateral sclerosis Acute myeloid leukemia IgAN IgA nephropathy IPF ITP LBCL BC Breast cancer LN mCRPC MDS Appendix C3G C3 glomerulopathy MHSPC Idiopathic pulmonary fibrosis. Immune thrombocytopenia Large B-cell lymphoma Lupus nephritis Metastatic castration-resistant prostate cancer Myelodysplastic syndrome Metastatic hormone sensitive prostate cancer CART Chimeric androgen receptor T mPDAC Metastatic pancreatic ductal adenocarcinoma Innovation: Pipeline overview CLL Chronic lymphocytic leukemia Financial performance CML Chronic myeloid leukemia MS NASH Multiple sclerosis Innovation: Clinical trials CRC Colorectal cancer nmCRPC Abbreviations COPD Chronic obstructive pulmonary disease COSP Chronic ocular surface pain NPR1 nr-axSpA References 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 Esophageal squamous-cell carcinoma PsA Psoriatic arthritis FL GCA GVHD GRPR HCC HD Follicular lymphoma Giant cell arteritis Graft-versus-host disease Hepatocellular carcinoma Huntington's disease rHR Resistant hypertension rMS rPFS Gastrin releasing peptide receptor SLE SMA Type 1 HR LBCL High risk large B-cell lymphoma ΙΑ Interim analysis iAMD Intermediate age-related macular degeneration SpA T1DM WAIHA Warm autoimmune hemolytic anemia SMA Type 2/3 Relapsing multiple sclerosis Radiographic progression free survival Systemic lupus erythematosus Spinal muscular atrophy (IV formulation) Spinal muscular atrophy (IT formulation) Spondyloarthritis Type 1 Diabetes mellitus IC-MPGN Immune complex membranoproliferative glomerulonephritis □ NOVARTIS | Reimagining Medicine. Novartis Q4 Results | January 31, 2024 85#86↓ ↑ Content Click below to navigate through the document References Conclusions Appendix References EntrestoⓇ (slide 7 references) 1 IQVIA National Prescription Audit. 2 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 and EU. 3 AHA/ACC/HFSA/ESC. 4 Extension of regulatory data protection to November 2026 in EU based on approval of pediatric indication. Company overview Financial review KesimptaⓇ (slide 9 references) 1 Data on file. Global data as of Nov 2023. 2 Data on file. 3 Kappos et al., AAN 2020, Ofatumumab Versus Teriflunomide in Patients with Relapsing Multiple Sclerosis: Phase 3 ASCLEPIOS I and II Trials. 4 5 As per stability technical specification data, when the patient is ready to inject, it typically takes less than 1 minute a month to administer. Once-monthly dosing begins after the initial dosing period, which consists of 20 mg subcutaneous doses at weeks 0, 1, and 2. Patient must take pen out of the refrigerator 15-30 minutes before self-administering.. Please see Instructions for Use for more detailed instructions on preparation and administration of KESIMPTA. Ross AP, Nicholas J, Tai MH, et al. US Real-world satisfaction and experience with injection and autoinjector device for ofatumumab indicated for multiple sclerosis. LB09. Presented at: Consortium of Multiple Sclerosis Centers Annual Meeting; May 31-June 3, 2023; Aurora, CO. 6 Novartis KESIMPTA Sensoready® Pen survey HEORUSV201392 in US. June 2022. 7 Efficacy outcomes as measured by disability progression and brain volume change. 8 Cohen et al, Poster presented at American Academy of Neurology, Boston, 22-27 April 23. 9 Cohen et al, oral presentation at American Academy of Neurology, Boston, 22-27 April 23. □ NOVARTIS Reimagining Medicine Novartis Q4 Results | January 31, 2024 86

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