Q3 2023 Results - Reimagining Medicine

Made public by

sourced by PitchSend

27 of 93

Creator

Novartis logo
Novartis

Category

Healthcare

Published

Q3 2023

Slides

Transcriptions

#1Company overview Financial review Conclusions Appendix References Q3 2023 Results Investor presentation U NOVARTIS | Reimagining Medicine#2Company overview Financial review Conclusions Appendix References Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as "potential," "expected," "will," "planned," "pipeline," "outlook," or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding potential future, pending or announced transactions; or regarding potential future sales or earnings of Novartis; or regarding discussions of strategy, priorities, plans, expectations or intentions, including our transformation into a "pure-play" innovative medicines business; or regarding our liquidity or cash flow positions and our ability to meet our ongoing financial obligations and operational needs; or regarding our USD 15 billion share buyback; or regarding our appeal of the negative decision of the US District Court for the District of Delaware on the validity of our patent covering Entresto and combinations of sacubitril and valsartan. 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. There can be no guarantee that the investigational or approved products described in this presentation will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee expected benefits or synergies from the transactions described in this presentation will be achieved in the expected timeframe, or at all. In particular, our expectations could be affected by, among other things: liquidity or cash flow disruptions affecting our ability to meet our ongoing financial obligations and to support our ongoing business activities; the impact of a partial or complete failure of the return to normal global healthcare systems including prescription dynamics; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in this presentation; the potential that the benefits and opportunities expected from our planned spin-off of Sandoz may not be realized or may be more difficult or take longer to realize than expected; the uncertainties in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; safety, quality, data integrity, or manufacturing issues; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, investigations or disputes; our performance on environmental, social and governance measures; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. Supent® is a registered trademark of C.P. Pharmaceuticals International C.V. 2 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#3Company overview Financial review Conclusions Appendix References Vas Narasimhan, M.D. Chief Executive Officer Company overview 3 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#4Company overview Financial review Conclusions Appendix References Novartis delivers strong sales growth, robust margin expansion and raises guidance. Successfully spun Sandoz SUMMARY Growth and productivity1 % CC Core margin 37.4% (+270 bps) Core margin 36.9% (+290 bps) Successful spin-off of Sandoz Completed October 4, 2023 Several major innovation milestones in Q3 CosentyxⓇ IV formulation approved in US (PSA, AS, nr-axSpA) LeqvioⓇ approved in China and Japan KisqaliⓇ submitted in EU; US submission planned in Q4 2023 Clinically meaningful and statistically significant ■ 21% 19% ■ 12% 10% Sales Core Opinc Sales Q3 Core Oplnc 9M FY 2023 guidance raised¹ Sales expected to grow high single digit; Core Oplnc expected to grow mid to high teens (from low double digit to mid teens) Ph3 data for multiple assets with blockbuster potential ■ PluvictoⓇ mCRPC pre-taxane ■ Iptacopan IgAN ■ Remibrutinib CSU ■ LutatheraⓇ GEP-NETS 1. Continuing operations. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. Oplnc operating income. 4 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#5Company overview Financial review Conclusions Appendix References Strong Q3 growth driven by performance from Kesimpta®, EntrestoⓇ, KisqaliⓇ and PluvictoⓇ. Cosentyx® returns to growth Q3 sales GROWTH Kesimpta (ofatumumab) Entresto sacubitril/valsartan Sales USD million Growth vs. PY Growth vs. PY CC USD million 657 368 124% 1,485 350 31% KISQALI 562 235 76% ribociclib PLUVICTO™ 256 176 217% Strong growth (+41% cc); SCEMBLIX' 106 65 157% expected to continue (asciminib) LEQVIO 90 56 165% Cosentyx 1,329 55 4% (secukinumab) ILARIS (canakinumab) 335 63 24% PROMACTA® 576 53 10% (eltrombopag) Xolair Omalizumab 369 47 13% JAKAVI ruxolitinib 427 41 9% Constant currencies (cc) is a non-IFRS measure; explanation of non-IFRS measures can be found on page 48 of Condensed Interim Financial Report. Unless otherwise noted, all growth rates refer to same period in PY. 5 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#6Company overview Financial review Conclusions Appendix References EntrestoⓇ delivers 31% growth with sales approaching USD 1.5bn in the quarter Sales evolution USD m, % cc GROWTH Entresto US weekly TRX1 Total prescriptions (000) 110 826 Strong Q3 momentum ■ US: robust growth outpacing market, sales +28% cc, ~1.4m TRx in Q31 ■ Ex-US: sales +34% cC ◉ China/Japan: significant contribution from HTN² Confidence in future growth Ex-US US 100 +31% 90 1,485 80 70 1,135 757 60 50 565 40 30 728 570 220 10 0 Q3 2022 Q3 2023 July 2015 See last page for references. RDP Regulatory data protection. Sept 2023 ■ Strong guidelines position³ (US/EU) ■ Expect further penetration in HF (2/3 eligible patients still on prior SoC) and HTN (China/Japan) ■ EU: paediatric approval confirms RDP to Nov 20264 ■ US: appeal filed to uphold validity of combination patent; other patent litigation ongoing and no generics have FDA approval 5 Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. SOC standard of care. TRX total prescriptions. HF heart failure. HTN hypertension. 6 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#7Company overview Financial review Conclusions Appendix References GROWTH Cosentyx® returns to growth; expecting stronger Q4 Cosentyx® Sales evolution USD m, % cc Ex-US US 1,274 +4% 1,329 Q3 performance ■▪ US sales (-3%): supported by volume growth, offset by PY base effects ◉ Ex-US sales (+15%): growth in core indications Q4 expect stronger sales growth ■ US: continuing volume growth; lower PY base due to Q4 2022 RD true-up " EU: HS approved in Q2, launch on track 612 532 Life cycle management ■ US: IV formulation approved, HS approval expected Q4 742 ■ 3 Ph3 studies ongoing: GCA, Polymyalgia Rheumatica, Rotator Cuff Tendinopathy 717 Q3 2022 Q3 2023 GCA Giant Cell Arteritis. HS-hidradenitis suppurativa. IV - intravenous. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. PSA and nr-axSpA. 7 Investor Relations | Q3 2023 Results 1. for adult AS, ✓ NOVARTIS | Reimagining Medicine#8Company overview Financial review Conclusions Appendix References KesimptaⓇ continues strong launch trajectory across regions Sales evolution USD m, % cc Ex-US US +124%* US: growing faster than market1,2 ■ TRX +75% Q3 vs. PY (market +3%) ■ NBRX +30% Q3 vs. PY (market +18%) 657 ■ B-cell NBRx share ~56% of MS market 250 289 407 239 Q3 2022 Q3 2023 GROWTH Kesimpta Europe: launch momentum progressing ■ >29k patients treated, majority naive or first switch ■ Q3 sales includes one-time revenue deduction adjustment* Confident in future growth Only about 1/3 of MS patients on B-cell therapy ■ NBRX leadership in key markets including Germany Compelling product profile: 1 minute a month dosing from home/anywhere³; 5-year efficacy4, safety and tolerability data 5,6 *Without the one-time revenue deduction adjustment, sales growth +86% cc See last page for references. TRX - total prescriptions. NBRX new to brand prescription. Interim Financial Report. MS Multiple Sclerosis. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed 8 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#9Company overview Financial review Conclusions Appendix References KisqaliⓇ sales grew 76% to USD 562m, with increasing recognition of its differentiated benefit-risk profile Sales evolution USD m, % cc Ex-US US +76% 562 US MBC NBRx share1 Rolling 3 months, % 268 23% 327 193 294 134 Q3 2022 Q3 2023 Aug 2022 Consistent efficacy GROWTH KISQALI Kisqali Ph3 OS results in 1L MBC2 46% Stage IV HR 95% CI MONALEESA-2 0.76 (0.63, 0.93) MONALEESA-7 0.76 (0.61, 0.96) MONALEESA-3 0.67 (0.50, 0.90) Aug 2023 Consistent OS benefit across 3 Ph3 studies NCCN guideline support as only Category 1 treatment for 1L mBC with Al³ Right Choice data showing benefit vs. doublet chemo in aggressive HR+/HER2- MBC Most adverse events asymptomatic mBC metastatic breast cancer. NBRX-new to brand prescription. 1. Of CDK4/6 mBC market, US 3 months ending Aug 2023, IQVIA Breast Cancer Market NCCN national comprehensive cancer network. Al aromatase inhibitor. 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 48 of Condensed Interim Financial Report. 9 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#10Company overview Financial review Conclusions Appendix References INNOVATION Kisqali® Ph3 NATALEE IDFS 500 event analysis complete, US submission planned for Q4 2023; file submitted in EU KISQALI Ph3 NATALEE results as presented at ASCO 20231 Second interim efficacy analysis at 426 iDFS events HR 95% CI IDFS total population 0.75 (0.62, 0.91) IDFS-stage II 0.76 (0.53, 1.10) iDFS - stage III 0.74 (0.59, 0.92) iDFS node negative 0.63 (0.34, 1.16) iDFS node positive 0.77 (0.63, 0.94) RFS 0.72 (0.58, 0.88) DDFS 0.74 (0.60, 0.91) OS 0.76 (0.54, 1.07) ESMO 2023 updates Consistent iDFS benefit² across subgroups: stage, menopausal status, age, nodal status Good tolerability profile³: addition of KisqaliⓇ to ET did not compromise patients' QoL on any of the scales evaluated Regulatory status / next steps Filed in Europe 500 iDFS event milestone reached; data consistent with interim analysis (March 20234) US submission planned for Q4 2023 1. Interim analysis. Slamon D, Stroyakovskiy D, Yardley D, et al. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer. 2. Slamon D, et al. ASCO 2023. LBA500 [Oral]. 3. Fasching PA, et al. ESMO 2023 Virtual Plenary. Oral VP3-2023. 4. Interim analysis in March 2023, data presented at ASCO 2023. 10 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#11Company overview Financial review Conclusions Appendix References PluvictoⓇ grew to USD 256m; supply now unconstrained, focusing on initiating new patients Sales evolution USD m, % cc Ex-US US +217% 256 18 238 80 6 74 Q3 2022 Q3 2023 11 Investor Relations | Q3 2023 Results GROWTH P PLUVICTO™ Continued progress in Q3 ■ Growth rates slowed in the quarter given supply challenges earlier in the year ■ >200 active centers ordering in US and onboarding another approximately 130 ■ Ex-US reimbursement discussions ongoing Supply capacity now unconstrained; maintaining reliability ■ Millburn capacity expanded with FDA approval of two additional lines Indianapolis site submitted for FDA approval ☐ NOVARTIS | Reimagining Medicine#12Company overview Financial review Conclusions Appendix References PSMAfore study showed robust efficacy with favorable safety of PluvictoⓇ in PSMA+ mCRPC patients in the pre-taxane setting Robust efficacy rPFS1 Median rPFS2 PSA50 response Time to SSE3 ORR4 PluvictoⓇ vs. ARPI arm HR 0.41 (0.29, 0.56) 12.0 vs. 5.6 months 57.6% vs. 20.4% HR 0.35 (0.22, 0.57) 50.7% vs. 14.9% ✓ Time to worsening (FACT-P5) HR 0.59 (0.47, 0.72) ✓ Time to worsening (BPI-SF6) HR 0.69 (0.56, 0.85) Crossover-adjusted OS HR 0.80 (0.48, 1.33) Favorable safety Vast majority of AEs low-grade Grade 3-4 AES: 33.9% PluvictoⓇ vs. 43.1% ARPI SAES: 20.3% PluvictoⓇ vs. 28.0% ARPI AEs leading to discontinuation7: 5.7% vs. 5.2% AEs leading to dose adjustment: 3.5% vs. 15.1% Overall exposure to PluvictoⓇ ~2,000 patient-years (incl. VISION, PSMAfore and post-marketing experience) Unadjusted OS (84% crossover) HR 1.16 (0.83, 1.64) Presented at ESMO; submission to FDA now planned in 2024 INNOVATION 1. Primary rPFS analysis based on 166 rPFS events per BICR assessment (or centrally confirmed rPFS events); 1-sided p-value: <0.0001. Updated analysis of rPFS (at time of 2nd interim OS analysis) was consistent, with HR 0.43 (0.33, 0.54). All other data points from updated analysis with more mature data. 2. (95% CI): 12.0 (9.3, 14.4) vs. 5.6 (4.2, 5.95). 3. SSE = symptomatic skeletal event. 4. ORR in soft tissue per RECIST 1.1 for pts with measurable disease at baseline; (95% CI): 50.7% (38.6, 62.8) vs. 14.9% (7.7, 25.0). 5. FACT-P: prostate cancer-specific quality of life. 6. BPI-SF: severity of pain and impact of pain on daily functions. 7. Comparisons for PluvictoⓇ vs. ARPI arm. 12 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#13Company overview Financial review Conclusions Appendix References ScemblixⓇ sales grew across all regions, demonstrating the high unmet need in CML Sales evolution USD m Ex-US US +157% 106 33 41 4 73 37 Q3 2022 Q3 2023 GROWTH SCEMBLIX® (asciminib) 20 mg, 40 mg tablets " Q3 sales reflect continued demand from patients with Ph+ CML-CP resistant or intolerant to 2 or more prior TKIs Leading market share 3L+ in US (NBR× 34%, TRX 20%) ■ Global rollout ongoing with strong performance in Japan and France ■ >40% of patients not satisfied with side effect profile of 1st and 2nd generation TKIs, highlighting need for more tolerable treatments1 ▪ ASC4FIRST (1L registrational study) readout and filing expected 2024 Ph+ CML-CP - Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. 1. 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). 13 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#14Company overview Financial review Conclusions Appendix References LeqvioⓇ adoption continues to expand steadily Sales evolution USD m Ex-US US = 64 78 34 == 90 90 35 35 US: Building foundation for acceleration Adoption ■ 3,100 facilities have ordered Leqvio® (+16% vs. Q2) ■ >55% of business is from buy and bill Enablers for future growth ■ Drive depth in key accounts with high utilization ■ Increase confidence in buy and bill 27 42 34 17 22 22 13 55 44 37 12 25 21 10 Q2 2022 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 B&B Buy and Bill. Pharmaceuticals, Inc. ■ Improve HCP targeting Ex-US rollout continues Approved in China and Japan GROWTH LEQVIO® LeqvioⓇ is administered initially, again at 3 months, and then once every 6 months. Novartis has obtained global rights to develop, manufacture and commercialize LeqvioⓇ under a license agreement with Alnylam 14 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#15Company overview Financial review Conclusions Appendix References Key 2023 readouts for high-value medicines on track INNOVATION Key assets* with submission enabling readouts in 2023 KisqaliⓇ Ph3 NATALEE trial in adjuvant breast cancer testing broad patient population (anatomical stage II and III1). 500 iDFS event milestone reached; data consistent with interim analysis (March 20232) Filed in EMA in Q3 FDA regulatory submission planned in Q4 2023 PluvictoⓇ PSMAfore trial in mCRPC (post-ARDT, pre-taxane) positive readout Detailed data presented at ESMO 2023 FDA regulatory submission now planned in 2024 Iptacopan PNH filed with FDA and EMA in Q2 2023 APPLAUSE-IgAN Ph3 met its pre-specified interim analysis primary endpoint3 in Q3 2023 APPEAR-C3G Ph3 readout expected in Q4 2023 Atrasentan IgAN readout expected in Q4 2023 *Unprobabilized estimated peak sales of all asset indications in late-stage development: > USD 1bn > USD 2bn > USD 3bn mCRPC metastatic castration resistant prostate cancer. ARDT androgen receptor directed therapy. 1. Based on AJCC prognostic staging. 2. Interim analysis in March 2023, data presented at ASCO 2023. 3. 9 months readout may support US submission for accelerated approval. 15 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#16Company overview Financial review Conclusions Appendix References Submission enabling readouts expected to increase in 2024-2025 timeframe INNOVATION Selected key assets* with submission enabling readouts in 2024-2025 Remibrutinib CSU Positive readout for primary analysis¹; data to be presented at ACAAI 2023 Final (52 weeks) readout and submission expected in 2024 ScemblixⓇ 1L CML-CP Readout and submission expected in 2024 PluvictoⓇ MHSPC Readout and submission planned in 20242 OAV-101 SMA IT Readout expected in 2024; submission planned in 2025 Pelacarsen CVRR Readout and submission expected in 2025 lanalumab 1L and 2L ITP readouts expected in 2025 with submission planned in 2026 Additional hematology and immunology indications 2026+ *Unprobabilized estimated peak sales of all asset indications in late-stage development: > USD 1bn > USD 2bn Iptacopan Additional readouts/submissions expected in 2025/2026+ > USD 3bn CSU chronic spontaneous urticaria. reduction. ITP immune thrombocytopenia. CML-CP - chronic myeloid leukemia in chronic phase. mHSPC metastatic hormone-sensitive prostate cancer. 1. Double blind treatment period of 24 weeks with primary analysis at 12 weeks. 2. Event-driven trial endpoint. SMA IT-spinal muscular atrophy intrathecal. CVRR-cardiovascular risk 16 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#17Company overview Financial review Conclusions Appendix References Remibrutinib demonstrated clinically meaningful and statistically significant benefit in Ph3 CSU trials Ph3 REMIX 1 & 2 studies Remibrutinib ~450 patients per study Screening R 2:1 Placebo Remibrutinib Follow up or extension Remibrutinib met ALL primary and secondary endpoints at 12 weeks Clinically meaningful and statistically significant reduction in urticaria activity Fast symptom improvement as early as 2 weeks¹ Well tolerated and favorable safety profile (incl. balanced liver function tests) Oral W-4 D 1 W 12 PE Double-blind treatment period PA W 24 Open-label treatment period W 52 W 56 All participants on a stable, locally label approved dose of a second generation H₁-AH ("background therapy") throughout the entire study Next steps Presentation at ACAAI 2023; final 52 week readout and filing expected in 2024 CSU Chronic spontaneous urticaria. PA Primary analysis. 1. As illustrated by a higher proportion of patients achieving UAS7≤6 at Week 2 in the REMIX-1 and REMIX-2 studies when treated with remibrutinib compared to placebo. 17 Investor Relations | Q3 2023 Results INNOVATION ✓ NOVARTIS | Reimagining Medicine#18Company overview Financial review Conclusions Appendix References Remibrutinib - opportunity for efficacious oral therapy with fast onset of action¹ after antihistamines INNOVATION Remibrutinib, a highly selective oral BTKi WW: 40m CSU patients²; US: ~1.1m treated adults with CSU³ Antihistamines CSU treatment gap Biologics ~600k³ patients controlled with SoC4 ~400k³ patients not controlled with SoC4 Only ~80k3 patients treated with biologics High unmet need after antihistamines Opportunity for Remibrutinib HCP Healthcare professional. CSU Chronic spontaneous urticaria. SOC Standard of care. 1. As illustrated by a higher proportion of patients achieving UAS7≤6 at Week 2 in the REMIX-1 and REMIX-2 studies when treated with remibrutinib compared to placebo. 2. Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy. 2011;66:317-330 and The World Bank. Population, total. Available from: https://data.worldbank.org/indicator/SP.POP.TOTL [Last accessed: July 2023]. 3. US only Novartis internal analysis. 4. H1, H2 antihistamines and antihistamines escalation. 18 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#19Company overview Financial review Conclusions Appendix References INNOVATION Iptacopan is a potential first-in-class, oral, selective factor B inhibitor, targeting complement system proximally via alternative pathway1 Indication 2021 2022 2023 2024 2025 2026+ Key updates PNH Ph3 - APPLY Ph3-APPOINT IgA Ph3 - APPLAUSE * nephropathy C3G Ph3 - APPEAR aHUS Ph3 APPELHUS Superior to SoC for both primary endpoints in patients with residual anemia despite SoC Achieved clinically meaningful increases in Hb levels in treatment-naive patients with PNH Clinically meaningful and highly statistically significant proteinuria reduction at 9 months Submission enabling readout Q4 2023 US prevalence Thousands <10 1852 <10 Submission enabling readout in 2025 <10 Ph3 started <10 IC-MPGN Ph3 Additional ongoing early-stage (Ph2) activities in Lupus Nephritis, iAMD * 9 months readout may support US submission for accelerated approval aHUS PNH - paroxysmal nocturnal hemoglobinuria. IgAN - immunoglobulin A nephropathy. C3G complement 3 glomerulopathy. IC-MPGN - immune complex membranoproliferative Glomerulonephritis. 1. Phase 3 studies initiated; additional indications are being explored. > 1g/day (~25-30%). 19 Investor Relations | Q3 2023 Results atypical hemolytic uremic syndrome. iAMD - intermediate age-related macular degeneration. 2. Estimated -46-55k number of US patients at high risk of progression with proteinuria ✓ NOVARTIS | Reimagining Medicine#20Company overview Financial review Conclusions Appendix References INNOVATION Iptacopan demonstrated clinically meaningful and highly statistically significant proteinuria reduction in Ph3 APPLAUSE-IgAN Ph3 APPLAUSE-IgAN Biopsy-confirmed patients with IgA nephropathy at risk of progression with elevated proteinuria (UPCR1 ≥1g/g) despite stable background therapy² Randomization Interim analysis End of study n= 250 at 9 months n = ~430 ☹ R 1:1 Iptacopan 200mg BID³ Placebo Day 1 | I Month 9 Option to roll-over in open-label extension study Month 24 (2025) Positive top-line results at pre-specified interim analysis Superiority vs placebo in proteinuria reduction on top of optimized supportive care Clinically meaningful and highly statistically significant proteinuria reduction Safety profile consistent with previously reported data Oral Next steps In discussions with FDA to submit for accelerated approval Study continues to assess superiority in slowing disease progression (eGFR slope) for full approval IgAN - IgA nephropathy. eGFR - estimated glomerular filtration. 1. UPCR (urine protein-to-creatinine ratio) from 24-h urine collection. 2. Including at least maximally tolerated dose of ACEI/ARB for at least 90 days. 20 Investor Relations | Q3 2023 Results 3. BID twice daily. ✓ NOVARTIS | Reimagining Medicine#21Company overview Financial review Conclusions Appendix References LutatheraⓇ Ph3 NETTER-2 results highlight the potential for radioligand therapy (RLT) in earlier disease settings INNOVATION Demonstrated clinically meaningful and statistically significant benefit in first line setting ■ Met primary endpoint of improvement in PFS and key secondary endpoint of ORR NETTER-2 supports potential acceleration of treatment with RLT to 1L ~170k NET patients in US; GEP-NET represent 55-70% " Safety consistent with well-established profile of LutatheraⓇ R 2:1 LutatheraⓇ 7.4 GBq Q8W x 4 PD + octreotide LAR 30 mg Somatostatin Analogs (SSAs) 1L >50% treated GEP-NET patients in 1L, treated with SSAS LutatheraⓇ; everolimus; SutentⓇ 2L ~30% of treated patients in 2L, where LutatheraⓇ sees most of its use today Follow-up visits every Captem; LutatheraⓇ; everolimus 10-15% of patients in 3L 3L 6 months for 3 years Captem; other chemo; everolimus ~5% of patients in 4L 4L High-dose octreotide LAR (60 mg) Q4W PD GEP-NET - gastroenteropancreatic neuroendocrine tumors. 21 Investor Relations | Q3 2023 Results Next steps Full data to be presented at upcoming medical meeting and provided to guideline committees NOVARTIS | Reimagining Medicine#22Company overview Financial review Conclusions Appendix References Harry Kirsch Chief Financial Officer Financial review and 2023 guidance 22 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#23Company overview Financial review Conclusions Appendix References 2023 performance continues our track record of consistent top-line growth and core margin expansion Continuing operations¹ performance, numbers restated post-Sandoz spin-off Net sales % growth % cc, USD bn Core Oplnc² % growth % cc, USD bn 5% 7% 9% 12% 10% 10% 16% 21% 19% 19% Core margin² (%), growth bps cc vs. PY 35.1 36.2 FINANCIAL PROFILE +290bps 37.4 37.1 36.9 FY 22 42.2 Q1 23 Q2 23 Q3 23 10.8 11.4 11.8 9M 23 34.0 FY 22 14.8 Q1 23 3.9 Q2 23 4.2 Q3 23 4.4 9M 23 12.6 FY 22 Q1 23 Q2 23 Q3 23 9M 23 In USD bn 1. As defined on page 37 of the Condensed Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities results and constant currencies are non-IFRS measures. Details regarding non-IFRS measures can be found starting on page 48 of the Condensed Interim Financial Report. 2. Core Unless otherwise noted, all growth rates refer to same period in PY. 23 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#24Company overview Financial review Conclusions Appendix References Robust top and bottom-line growth during the quarter and YTD FINANCIAL PROFILE Continuing operations¹ Change vs. PY Q3 9M Change vs. PY USD million 2023 % USD % CC² 2023 % USD % CC² Net sales 11,782 12 12 34,017 8 10 Core operating income² 4,405 17 21 12,551 13 19 Operating income 1,762 -4 13 7,187 16 31 Net income 1,513 14 37 5,934 25 41 Core EPS (USD)² 1.74 EPS (USD) 0.73 22 24 29 4.95 21 28 20 45 2.84 31 49 Free cash flow² 5,043 24 11,019 27 1. As defined on page 37 of the Condensed Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities results and constant currencies are non-IFRS measures. Details regarding non-IFRS measures can be found starting on page 48 of the Condensed Interim Financial Report. 2. Core Unless otherwise noted, all growth rates refer to same period in PY. 24 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#25Company overview Financial review Conclusions Appendix References FINANCIAL PROFILE Significant improvement in core margin for continuing operations Q3 2023 Core operating Net sales change vs. PY1 income change vs. PY1 Core margin Core margin (in % cc) (in % cc) (%) change vs. PY1 (%pts cc) Net sales change vs. PY1 9M 2023 Core operating income change vs. PY1 Core margin¹ Core margin change vs. PY1 (in % cc) (in % cc) (%) (%pts cc) Continuing operations² 12 21 37.4 2.7 10 19 36.9 2.9 Discontinued operations² 6 -38 10.1 -9.3 8 -11 16.0 -3.7 Group 9 14 33.8 1.3 9 15 34.1 2.0 1. Constant currencies (cc), core results are non-IFRS measures. Explanation of non-IFRS measures can be found on page 48 of the Condensed Interim Financial Report 2. As defined on page 37 of the Condensed Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the Innovative Medicines Division and the continuing Corporate activities and Discontinued operations include operational results from Sandoz business. 25 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#26Company overview Financial review Conclusions Appendix References Raising FY guidance for core operating income Expected, barring unforeseen events; growth vs. PY in cc Novartis (Continuing operations¹) Net sales expected to grow high single digit Core operating income expected to grow mid to high teens Unchanged from previous guidance Raised from low double digit to mid-teens Key assumptions ■ No US Entresto® Gx at risk launch in 2023 ■ No SandostatinⓇ LAR generics enter in the US in 2023 FINANCIAL PROFILE 1. As defined on page 37 of the Condensed Interim 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 48 of the Condensed Interim Financial Report. 26 Investor Relations | Q3 2023 Results ✓ NOVARTIS | Reimagining Medicine#27Company overview Financial review Conclusions Appendix References STRATEGY Novartis maintains strong commitment to shareholder value creation Investing in the business Investments in organic business R&D >USD 45bn, CAPEX >USD 5bn 2018-YTD 20231 Value-creating bolt-ons >USD 33bn 2018-YTD 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. 27 Investor Relations | Q3 2023 Results Apr 2019 Spun Alcon Returning capital to shareholders Consistently growing annual dividend² >USD 42bn of dividends 2018-YTD 2023 No rebasing post Alcon and Sandoz spin-off Share buybacks >USD 30bn 2018-YTD 2023 New USD 15bn SBB commenced in Jul 2023 Nov 2021 Oct 2023 Exited Roche stake Spun Sandoz NOVARTIS | Reimagining Medicine#28Company overview Financial review Conclusions Appendix References Vas Narasimhan, M.D. Chief Executive Officer 28 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#29Company overview Financial review Conclusions Appendix References Delivered a very strong quarter, upgraded FY 2023 guidance. Maintaining our commitment to shareholder value creation Very strong Q3: sales +12%, core operating income +21% (cc, continuing operations) Growth drivers continue to perform well in the market: incl. KesimptaⓇ, EntrestoⓇ, KisqaliⓇ and PluvictoⓇ Robust pipeline: innovation milestones for Cosentyx®, PluvictoⓇ, iptacopan, remibrutinib, LutatheraⓇ Successfully completed the Sandoz spin-off: focusing on our core business of innovative medicines Raising 2023 FY guidance 29 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#30Company overview Financial review Conclusions Appendix References Novartis Capital Markets Day, focus R&D November 28, 2023 London Key R&D assets will include: Kisqali®, Pluvicto®, Scemblix®, iptacopan, remibrutinib Additionally, a short update on strategy 30 Investor Relations | Q3 2023 Results 1 NOVARTIS | Reimagining Medicine#31Company overview Innovation: Pipeline overview Financial review Financial performance Appendix Conclusions Appendix Innovation: Clinical trials References Abbreviations 31 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#32Company overview Innovation: Pipeline overview Financial review Financial performance 2023 expected key events Conclusions Appendix Innovation: Clinical trials References Abbreviations INNOVATION Regulatory Cosentyx® HS decisions CosentyxⓇ 2ml Al Cosentyx® IV Leqvio® Hypercholesterolemia Submissions Iptacopan PNH (US/EU/JP) KisqaliⓇ HR+/HER2- BC (adj) PluvictoⓇ mCRPC, pre-taxane (US) Readouts KisqaliⓇ HR+/HER2-BC (adj) Iptacopan IgAN Iptacopan C3G LutatheraⓇ GEP-NETS Ph3 starts Iptacopan in IC-MPGN H1 2023 EU H2 2023 US Status update - as of end Q3 EU approval (Q2) US US approval (Q2) US US approval (Q3) JP, China US/EU JP US US NATALEE Ph3 FIR APPLAUSE-IgAN Ph3 APPEAR-C3G Ph3 NETTER-2 Ph3 Leqvio® CVRR primary prevention Ph3 lanalumab in immune thrombocytopenia lanalumab in systemic lupus erythematosus Ph3 Ph3 HS hidradenitis suppurativa. PNH - paroxysmal nocturnal hemoglobinuria. C3G complement 3 Glomerulopathy. mCRPC metastatic castration-resistant prostate cancer. IC-MPGN - immune complex membranoproliferative glomerulonephritis. Japan and China approval in Q3 Filed in US, EU (Q2), JP (Q3) Filed in EU in Q3, US submission planned in Q4 US submission expected in 2024 Primary endpoint met at interim analysis; 500 iDFS event milestone reached; data consistent with interim analysis (March 20231) Met pre-specified interim analysis primary endpoint in Q3 Met primary endpoint in Q3 APPARENT trial (Q2) VICTORION-1P (Q1) 1L (VAYHIT1) and 2L (VAYHIT2) FPFV (H1) SIRIUS-SLE 1 and 2 (Q1) FIR - first interpretable results. IgAN-immunoglobulin A nephropathy. 1. Interim analysis in March 2023, data presented at ASCO 2023. 32 Investor Relations | Q3 2023 Results U NOVARTIS | Reimagining Medicine#33Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Our pipeline projects at a glance Appendix Innovation: Clinical trials References Abbreviations Phase 1/2 Phase 3 Registration Total Oncology Solid tumors Hematology Immunology 28 11 2 41 16 4 1 21 12 7 1 20 19 11 2 32 Neuroscience 5 5 0 10 Cardiovascular 5 10 0 15 Others (thereof IB&GH) 13 (9) 2 (1) 0 15 70 39 4 113 IB&GH: In-market Brands and Global Health. 33 Investor Relations | Q3 2023 Results INNOVATION 1 NOVARTIS | Reimagining Medicine#34Company overview Innovation: Pipeline overview Financial review Financial performance Novartis pipeline in Phase 1 Oncology Code Name Solid tumors AAA603 177Lu-NeoB AAA614 AAA614 AAA817 DFF332 DFF332 HRO761 HRO761 IAG933 IAG933 KFA115 KFA115 MGY825 MGY825 NZV930 NZV930 QEQ278 QEQ278 225AC-PSMA-617 Hematology DFV890 DFV890 sabatolimab PIT565 MBG453 PIT565 YTB323 Mechanism Radioligand therapy target GRPR Radioligand therapy target FAP Radioligand therapy target PSMA HIF2A inhibitor Werner inhibitor Novel immunomodulatory Agent CD73 antagonist NKG2D/-L pathway modulator NLRP3 inhibitor TIM3 antagonist rapcabtagene autoleucel CD19 CAR-T Indication(s) Multiple solid tumors Breast cancer Solid tumors Metastatic castration-resistant prostate cancer Renal cell carcinoma Solid tumors Mesothelioma Solid tumors NSCLC Solid tumors Solid tumors Low risk myelodysplastic syndrome Low risk myelodysplastic syndrome B-cell malignancies Adult ALL Neuroscience Code Name DFT383 DFT383 NIO752 NIO752 Mechanism CTNS gene delivery Tau antisense oligonucleotide Indication(s) Cystinosis pre/post kidney transplant Alzheimer's disease Progressive supranuclear palsy Cardiovascular Code Name XXB750 XXB750 Mechanism NPR1 agonist 34 Investor Relations | Q3 2023 Results Indication(s) Heart failure Conclusions Appendix Innovation: Clinical trials Immunology References Abbreviations INNOVATION 16 lead indications Code Name MHV370 MHV370 Mechanism TLR7, TLR8 Antagonist Indication(s) Systemic lupus erythematosus Others Name Mechanism Code IB&GH EDI048 EDI048 EYU688 EYU688 INE963 INE963 CpPI(4)K inhibitor NS4B inhibitor Indication(s) Cryptosporidiosis Dengue Malaria, uncomplicated Lead indication NOVARTIS | Reimagining Medicine#35Company overview Innovation: Pipeline overview Financial review Financial performance Novartis pipeline in Phase 2 Oncology Conclusions Appendix Innovation: Clinical trials Immunology References Abbreviations INNOVATION 21 lead indications Code Name Mechanism Indication(s) Solid tumors AAA601 BCR-ABL inhibitor JDQ443 opnurasib TNO155 TNO155 Hematology ABL001 ScemblixⓇ INC424 Jakavi® MBG453 sabatolimab PHE885 durcabtagene autoleucel PKC412 Rydapte YTB323 rapcabtagene autoleucel JAK1/2 inhibitor TIM3 antagonist BCMA cell therapy Multi-targeted kinase inhibitor CD19 CAR-T Acute myeloid leukemia, pediatrics 1L high-risk large B-cell lymphoma LutatheraⓇ Radioligand therapy target SSTR GEPNET, pediatrics 1L ES-SCLC Glioblastoma LNA043 LNA043 KRAS inhibitor SHP2 inhibitor NSCLC and CRC (mono and/or combo) Solid tumors LOU064 remibrutinib BTK inhibitor Code CFZ533 Name iscalimab Mechanism CD40 inhibitor DFV890 DFV890 NLRP3 inhibitor Indication(s) Chronic myeloid leukemia, 2L, pediatrics Acute GVHD, pediatrics Chronic GVHD, pediatrics Unfit acute myeloid leukemia LRX712 LRX712 MAS825 MAS825 MHV370 MHV370 Acute myeloid leukemia, maintenance 4L multiple myeloma NG1226 NG1226 QUC398 QUC398 RHH646 RHH646 ANGPTL3 agonist TLR7, TLR8 Antagonist ADAMTS5 inhibitor Sjögren's Hidradenitis suppurativa Knee osteoarthritis Familial cold auto-inflammatory syndrome Knee osteoarthritis Osteoarthritis (combos) Food allergy Hidradenitis suppurativa Sjögren's Osteoarthritis NLRC4-GOF indications Sjögren's Mixed connective tissue disease Tendinopathy Osteoarthritis Osteoarthritis VAY736 ianalumab YTB323 rapcabtagene autoleucel BAFF-R inhibitor CD19 CAR-T Autoimmune hepatitis srSLE/LN Neuroscience Code Name BLZ945 sotuletinib DLX3131 minzasolmin Mechanism CSF-1R inhibitor Alpha-synuclein misfolding inhibitor Indication(s) Others Amyotrophic lateral sclerosis Parkinson's disease Code IB&GH Name KAE609 cipargamin KLU156 Indication(s) Ganaplacide + lumefantrine Cardiovascular Code Name CFZ533 iscalimab LNP023 iptacopan TIN816 TIN816 XXB750 Mechanism CD40 inhibitor Lupus nephritis CFB inhibitor Lupus nephritis ATP modulator XXB750 NPR1 agonist Acute kidney injury Hypertension 1. DLX313 is the Novartis compound code for UCB0599. 35 Investor Relations | Q3 2023 Results LXE408 LXE408 QMF149 Atectura® SEG101 Adakveo® Others Mechanism Indication(s) PfATP4 inhibitor Non-artemisinin plasmodium falciparum inhibitor Proteasome inhibitor LABA + ICS P-selectin inhibitor Malaria, severe Malaria, uncomplicated Malaria, uncomplicated Visceral leishmaniasis Asthma, pediatrics Sickle cell disease, pediatrics CMK389 CMK389 LNP023 LTP001 IL-18 inhibitor iptacopan LTP001 CFB inhibitor SMURF1 inhibitor Pulmonary sarcoidosis iAMD Pulmonary arterial hypertension Idiopathic pulmonary fibrosis Lead indication U NOVARTIS | Reimagining Medicine#36Company overview Innovation: Pipeline overview Financial review Financial performance Novartis pipeline in Phase 3 Oncology Code Name Solid tumors Mechanism Indication(s) AAA617 Conclusions PluvictoⓇ Radioligand therapy target PSMA Metastatic castration-resistant prostate cancer (mCRPC), pre-taxane AAA6011 LutatheraⓇ Radioligand therapy target SSTR KRAS inhibitor Metastatic hormone sensitive prostate cancer (mHSPC) Gastroenteropancreatic neuroendocrine tumors, 1st line in G2/3 tumors (GEP-NET 1L G3) 2/3L Non-small cell lung cancer JDQ443 opnurasib Hematology ABL001 ScemblixⓇ ETB115 Promacta® LNP023 iptacopan MBG453 VAY736 BCR-ABL inhibitor Thrombopoietin receptor (TPO-R) agonist CFB inhibitor sabatolimab ianalumab TIM3 antagonist BAFF-R inhibitor Chronic myeloid leukemia, 1st line Radiation sickness syndrome Atypical hemolytic uraemic syndrome Myelodysplastic syndrome 1L Immune Thrombocytopenia 2L Immune Thrombocytopenia warm Autoimmune Hemolytic Anemia Appendix Innovation: Clinical trials Cardiovascular References Abbreviations INNOVATION 8 lead indications Lead indication Code EXV811 atrasentan FUB523 zigakibart KJX839 Leqvio® Name Mechanism ETA receptor antagonist Anti-APRIL siRNA (regulation of LDL-C) LNP023 iptacopan CFB inhibitor TQJ230 pelacarsen ASO targeting Lp(a) Indication(s) IgA nephropathy IgA nephropathy CVRR-LDLC Primary prevention Hyperlipidemia, pediatrics IgA nephropathy C3 glomerulopathy C3 glomerulopathy, pediatrics IC-MPGN Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a) (CVRR-Lp(a)) Immunology Neuroscience Code Name AMG334 AimovigⓇ BAF312 MayzentⓇ LOU064 remibrutinib OAV101 AVXS-101 OMB157 KesimptaⓇ Mechanism CGRPR antagonist S1P1,5 receptor modulator BTK inhibitor SMN1 gene replacement therapy CD20 Antagonist Indication(s) Migraine, pediatrics Multiple sclerosis, pediatrics Multiple sclerosis SMA IT administration Multiple sclerosis, pediatrics Code AIN457 Name Cosentyx® Mechanism IL17A inhibitor IgE inhibitor remibrutinib IGE025 Xolair® LOU064 QGE031 ligelizumab VAY736 ianalumab BTK inhibitor IgE inhibitor BAFF-R inhibitor Indication(s) Giant cell arteritis: Polymyalgia rheumatica Rotator cuff tendinopathy Food allergy Chronic spontaneous urticaria Chronic spontaneous urticaria, pediatrics CINDU Food allergy Sjögren's Lupus Nephritis Systemic lupus erythematosus 1. 177 Lu-dotatate in US. 36 Investor Relations | Q3 2023 Results Others Code IB&GH Name Mechanism COA566 Coartem® PGH-1 (artemisinin combination therapy) Others RTH258 BeovuⓇ VEGF Inhibitor Indication(s) Malaria, uncomplicated (<5kg patients) Diabetic retinopathy NOVARTIS | Reimagining Medicine#37Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Novartis pipeline in registration Oncology Code Indication(s) Name Solid tumors LEE011 Kisqali® Mechanism CDK4/6 Inhibitor HR+/HER2- BC (adj) Hematology LNP023 iptacopan CFB inhibitor Immunology Code Name Mechanism AIN457 IGE025 Cosentyx® Xolair® IL17A inhibitor IgE inhibitor 1. Approved in EU. Paroxysmal nocturnal hemoglobinuria Indication(s) Hidradenitis suppurativa¹ Auto-injector Appendix Innovation: Clinical trials References Abbreviations INNOVATION 1 lead indications Lead indication 37 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#38Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Novartis submission schedule New Molecular Entities: Lead and supplementary indications Lead Supplementary 2023 iptacopan LNP023 PNH 38 Investor Relations | Q3 2023 Results 2024 atrasentan EXV811 IgAN opnurasib JDQ443 2/3L NSCLC (mono) remibrutinib LOU064 CSU sabatolimab MBG453 HR-MDS iptacopan LNP023 C3G iptacopan LNP023 IgAN PluvictoⓇ AAA617 mCRPC, Pre-taxane PluvictoⓇ AAA617 MHSPC E 2025 pelacarsen TQJ230 CVRR-Lp(a) Appendix Innovation: Clinical trials References Abbreviations INNOVATION Cardiovascular Immunology Neuroscience Oncology Non-core TA project ≥2026 177 Lu-NeoB AAA603 Multiple Solid Tumors. ianalumab VAY736 2L Immune Thrombocytopenia iscalimab CFZ533 Sjögren's syndrome ligelizumab QGE031 Food allergy LNA043 Knee osteoarthritis rapcabtagene autoleucel YTB323. High-risk large B-cell lymphoma TNO155 Solid tumors XXB750 Hypertension zigakibart FUB523 IgAN cipargamin KAE609 Malaria severe ganaplacide/lumefantrine KLU156 Malaria uncomplicated LXE408 Visceral leishmaniasis ianalumab VAY736 1L Immune Thrombocytopenia ianalumab VAY736 WAIHA ianalumab VAY736 AIH ianalumab VAY736 Sjögren's syndrome cipargamin KAE609 Malaria uncomplicated ianalumab VAY736 Lupus Nephritis ianalumab VAY736 SLE iptacopan LNP023 aHUS iptacopan LNP023 IC-MPGN opnurasib JDQ443 NSCLC (Combo) rapcabtagene autoleucel YTB323 Lupus Nephritis remibrutinib LOU064 Multiple sclerosis remibrutinib LOU064 Sjögren's syndrome remibrutinib LOU064 CINDU sabatolimab MBG453 Unfit AML D D © NOVARTIS | Reimagining Medicine#39Existing brands Company overview Innovation: Pipeline overview Financial review Financial performance Novartis submission schedule Supplementary indications for existing brands Conclusions Appendix Innovation: Clinical trials References Abbreviations INNOVATION Cardiovascular Immunology Neuroscience Oncology Non-core TA project Kisqali® 2023 ribociclib, LEE011 HR+/HER2- BC (adj) XolairⓇ omalizumab, IGE025 Food allergy JakaviⓇ 2024 ruxolitinib, INC424 Pediatrics Acute GVHD JakaviⓇ ruxolitinib, INC424 Pediatrics Chronic GVHD LutatheraⓇ 177Lu-oxodotreotide¹ GEP-NET 1L G3 ScemblixⓇ ABL001 CML 1L Adakveo SEG101 Sickle cell disease, pediatrics Coartem® artemether+lumefantrine, COA566 Malaria uncompl., formula for <5kg 2025 Cosentyx® secukinumab, AIN457 GCA Leqvio® KJX839 Ped Hyperlipidemia ZolgensmaⓇ AVXS-101 OAV101 SMA IT BeovuⓇ brolucizumab, RTH258 Diabetic retinopathy PromactaⓇ eltrombopag, ETB115 Radiation sickness syndrome AimovigⓇ erenumab, AMG334 Pediatric Migraine Cosentyx® secukinumab, AIN457 Tendinopathy CosentyxⓇ secukinumab, AIN457 Polymyalgia rheumatica AtecturaⓇ indacaterol + mometasone, QMF149 Asthma, pediatrics KesimptaⓇ 2 ofatumumab Multiple sclerosis, pediatrics LeqvioⓇ KJX839 CVRR-LDLC 1. 177 Lu-dotatate in US. 2. Kesimpta and Mayzent: Pediatric trial in multiple sclerosis run in conjunction (NEOS). 39 Investor Relations | Q3 2023 Results ≥2026 LeqvioⓇ KJX839 Primary prevention MayzentⓇ 2 siponimod, BAF312 Multiple sclerosis, pediatrics RydaptⓇ midostaurin, PKC412 Acute myeloid leukemia, pediatrics ScemblixⓇ ABL001 CML, 2L, pediatrics NOVARTIS | Reimagining Medicine O#40Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials Expected currency impact for full year 2023 and 2024 References Abbreviations Currency impact vs. PY %pts, assuming late-October exchange rates prevail in 2023 and 2024 -2 FX impact on Net sales 0 I FX impact on Core operating income FINANCIAL PROFILE -1 to -2 -2-1 to -2 -3 -4 I -4 -6 -6 -6 -8 I Q1 Q2 Q3 Q4 FY¦ FY Q1 Q2 Q3 Q4 FY 2023 2024 2023 FY I 2024 Actual Simulation 40 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#41Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials FY 2023 guidance on other financial KPIs Barring unforeseen events; (in cc) Continuing operations | Full year guidance Core Net Expenses expected to be around 0.5bn. Financial Result Expected to be in the 15-16% range Core Tax Rate References Structurally lower tax rate vs. Novartis incl. Sandoz due to different geographic mix Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. 41 Investor Relations | Q3 2023 Results Abbreviations FINANCIAL PROFILE NOVARTIS | Reimagining Medicine#42Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials Net debt increased by USD 3.6bn mainly due to dividends and share buybacks, partially offset by FCF USD bn -7.2 -7.3 -7.3 Dec 31, 2022 Dividends Treasury share transactions, net -2.9 M&A/Intangible assets transactions, net -3.6 References Abbreviations FINANCIAL PROFILE -10.8 -0.1 3.0 11.0 Free Cash Flow Others Net debt Sandoz 1 Sep 30, 2023 1. Reflects USD 0.6bn cash and USD 3.7bn of financial debts of Sandoz as of Sep 30, 2023. In addition, on Oct 2, 2023, through a series of intercompany transactions in connection with the distribution (spin-off) of the Sandoz business to Novartis AG shareholders, USD 38m was paid in cash from a Novartis affiliate to the Sandoz business. Including this transaction, Sandoz cash on Oct 2, 2023, amounted to USD 0.7bn. 42 Investor Relations | Q3 2023 Results U NOVARTIS | Reimagining Medicine#43Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Conclusions Neuroscience Appendix Innovation: Clinical trials Clinical Trials Update Includes selected ongoing or recently concluded global trials of Novartis development programs/products which are in confirmatory development or marketed (typically Phase 2b or later). For further information on all Novartis clinical trials, please visit: www.novartisclinicaltrials.com Oncology References Abbreviations Other 43 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#44Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Conclusions Cardiovascular Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 44 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#45Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology iptacopan - CFB inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology iptacopan - CFB inhibitor References Abbreviations Other NCT04578834 APPLAUSE-IgAN (CLNP023A2301) Indication Phase IgA nephropathy Phase 3 Indication Phase NCT05755386 APPARENT (CLNP023B12302) Immune complex-mediated membranoproliferative glomerulonephritis Phase 3 Patients 450 Patients 68 Primary Outcome Measures Ratio to baseline in urine protein to creatinine ratio (sampled from 24h urine collection) at 9 months Primary Outcome Measures Annualized total estimated Glomerular Filtration Rate (eGFR) slope estimated over 24 months 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 Intervention Target Patients Arm 1 LNP023 200mg BID Arm 2 - Placebo BID Primary IgA Nephropathy patients Readout Milestone(s) 2023 (primary endpoint for US initial submission, 9 months UPCR) 2025 (24 months) Arms Intervention Publication TBD 45 Investor Relations | Q3 2023 Results Readout Milestone(s) Publication 2026 TBD NOVARTIS | Reimagining Medicine#46Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Neuroscience iptacopan - CFB inhibitor Appendix Innovation: Clinical trials Oncology iptacopan - CFB inhibitor References Abbreviations Other NCT03955445 (CLNP023B12001B) NCT04817618 APPEAR-C3G (CLNP023B12301) C3 glomerulopathy Phase 3 Indication C3 glomerulopathy (C3G) Indication Phase Phase 2 Phase Patients 27 patients from ongoing Ph2 (sample size from Ph3 pending HA discussions Q1 2021), total patients for this study will increase Patients 83 Primary Outcome Measures Arms Intervention Target Patients Characterize the effect of LNP023 treatment on a composite renal response endpoint at 9 months (1. a stable or improved eGFR and, 2. a reduction in proteinuria and 3. an increase in C3 compared to the CLNP023X2202 baseline visit) Open-label LNP023 200mg bid Patients with C3 glomerulopathy Readout 2025 Milestone(s) Publication TBD Primary Outcome Measures 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 Arms Intervention Target Patients Readout Milestone(s) Publication 2023 TBD 46 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#47Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology LeqvioⓇ - siRNA (regulation of LDL-C) Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology NCT03705234 ORION-4 (CKJX839B12301) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH) Phase 3 15000 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 2026 Publication TBD 47 Investor Relations | Q3 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#48Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology LeqvioⓇ - siRNA (regulation of LDL-C) Appendix Innovation: Clinical trials Neuroscience Oncology References Leqvio® - siRNA (regulation of LDL-C) Indication Phase NCT04652726 ORION-16 (CKJX839C12301) Hyperlipidemia, pediatrics Phase 3 Indication NCT04659863 ORION-13 (CKJX839C12302) Hyperlipidemia, pediatrics Phase Phase 3 Patients 141 Patients 13 Primary Outcome Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 330 Measures Primary Outcome Measures Arms Arms Intervention Target Patients 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 Readout Milestone(s) (LDL-C) 2025 Publication TBD 48 Investor Relations | Q3 2023 Results Abbreviations Other 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 | Reimagining Medicine#49Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology LeqvioⓇ - siRNA (regulation of LDL-C) Appendix Innovation: Clinical trials Neuroscience Oncology References Leqvio® - siRNA (regulation of LDL-C) Abbreviations Other NCT05030428 VICTORION-2P (CKJX839B12302) Indication Secondary prevention of cardiovascular events in patients with elevated levels of LDL-C Indication Phase NCT05739383 VICTORION-1P (CKJX839D12302) CVRR (Primary prevention) Phase 3 Phase 3 Target Patients Readout 2027 Milestone(s) Publication TBD Phase Patients Primary Outcome Measures Arms Intervention 16500 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) Patients 14000 Primary Outcome Measures Arms Intervention Target Patients Time to the first occurrence of 4P-MACE 4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization Arm 1 Experimental: Inclisiran Sodium 300mg, subcutaneous injection in pre-filled syringe Arm 2 Placebo High-risk primary prevention patients Readout Milestone(s) 2029 Publication TBD 49 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#50Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Appendix Innovation: Clinical trials Neuroscience Oncology pelacarsen - Antisense oligonucleotide (ASO) targeting Lp(a) NCT04023552 Lp(a)HORIZON (CTQJ230A12301) Indication Phase Patients Primary Outcome Measures Arms Intervention Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein(a) Phase 3 8323 Time to the first occurrence of MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization) TQJ230 80 mg injected monthly subcutaneously or matched placebo Patients with a history of Myocardial infarction or Ischemic Stroke, or a clinically significant symptomatic Peripheral Artery Disease, and Lp(a) ≥ 70 mg/dL Target Patients Readout 2025 Milestone(s) Publication TBD 50 Investor Relations | Q3 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#51Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology XXB750 - NPR1 agonist NCT05562934 (CXXB750B12201) Hypertension Indication Phase Phase 2b Patients 170 Primary Outcome Measures week 12 Arms Change from baseline in mean 24hr ambulatory systolic blood pressure at Intervention Target Patients Arm 1 experimental: Dose 1 Arm 2 experimental: Dose 2 Arm 3 experimental: Dose 3 Arm 4 experimental: Dose 4 Arm 5 placebo comparator Resistant Hypertension Patients Readout Milestone(s) 2024 Publication TBD Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 51 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#52Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Immunology Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 52 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#53Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Cosentyx® - IL-17A inhibitor NCT05767034 REPLENISH (CAIN457C22301) Polymyalgia rheumatica Indication Phase Phase 3 Patients 360 Primary Outcome Measures Arms Proportion of participants achieving sustained remission Appendix Innovation: Clinical trials Neuroscience Oncology Cosentyx® - IL-17A inhibitor NCT04930094 GCAPTAIN (CAIN457R12301) Giant cell arteritis Phase 3 Indication Phase Patients 348 Primary Outcome Measures Arms Intervention Number of participants with sustained remission 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 Adult patients with PMR who have recently relapsed Readout Milestone(s) 2025 Publication TBD Target Patients Experimental: Secukinumab 300 mg Placebo Comparator: Placebo Patients with Giant Cell Arteritis (GCA) Primary 2025 Final 2026 Readout Milestone(s) Publication TBD 53 Investor Relations | Q3 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#54Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Cosentyx® - IL-17A inhibitor NCT05722522 (CAIN457012301) Rotator cuff tendinopathy Phase 3 Indication Phase Patients 234 Primary Outcome Appendix Innovation: Clinical trials Neuroscience Oncology Cosentyx® - IL-17A inhibitor NCT05758415 (CAIN457012302) Indication Phase Rotator cuff tendinopathy Phase 3 Patients 234 References Abbreviations Other Measures Arms Intervention Target Patients Change from BSL in in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) score [ Time Frame: At Week 16 ]: - Improving physical shoulder symptoms in participants with moderate to severe RCT at Week 16 Arm 1: Secukinumab 2 X 150 mg / 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio Arm 2: Placebo 2X 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio Patients with moderate-severe Rotator Cuff Tendinopathy Primary Outcome Measures Arms Intervention Change from BSL in in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) score [ Time Frame: At Week 16 ]: - Change in physical shoulder symptoms in participants with moderate to severe RCT at Week 16 Arm 1 experimental: Secukinumab 2 X 150 mg / 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio Arm 2 placebo: 2 X 1 mL, subcutaneous (s.c.) injection, randomized in a 1:1 ratio Patients with moderate-severe Rotator Cuff Tendinopathy Readout Milestone(s) 2025 Publication TBD 54 Investor Relations | Q3 2023 Results Target Patients Readout Milestone(s) Publication 2025 TBD NOVARTIS | Reimagining Medicine#55Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology ianalumab - BAFF-R inhibitor NCT03217422 AMBER (CVAY736B2201) Indication Autoimmune hepatitis Phase 2 Phase Patients 68 Primary Alanine aminotransferase (ALT) normalization Outcome Measures Arms VAY736 Intervention Placebo control with conversion to active VAY736 Target Patients Autoimmune hepatitis patients with incomplete response or intolerant to standard treatment of care Readout 2024 Milestone(s) Publication TBD 55 Investor Relations | Q3 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology ianalumab - BAFF-R inhibitor NCT05126277 SIRIUS-LN (CVAY736K12301) Lupus Nephritis Phase 3 Indication Phase Patients 420 Primary Outcome Measures Arms Intervention References Abbreviations Other Frequency and percentage of participants achieving complete renal response (CRR) [ Time Frame: week 72] Arm 1: Experimental - ianalumab s.c. q4w in addition to standard of care (SoC) Arm 2: Experiemental - ianalumab s.c. q12w in addition to SoC Arm 3: Placebo comparator - Placebo s.c. q4w in addition to SoC Patients with active Lupus Nephritis Target Patients Readout Milestone(s) Publication Primary 2027 TBD NOVARTIS | Reimagining Medicine#56Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology ianalumab - BAFF-R inhibitor Indication NCT05349214 NEPTUNUS-2 (CVAY736A2302) Sjögren's syndrome Phase Phase 3 Patients 489 Primary Outcome Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Measures Arms Intervention Target Patients Arm 1: Experimental - ianalumab exposure level 1 Arm 2: Experimental - ianalumab exposure level 2 Arm 3: Placebo comparator Patients with active Sjogren's syndrome Readout Milestone(s) Primary 2026 Publication TBD 56 Investor Relations | Q3 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology ianalumab - BAFF-R inhibitor NCT05350072 NEPTUNUS-1 (CVAY736A2301) Sjögren's syndrome Indication Phase Phase 3 Patients 268 References Abbreviations Other Primary Outcome Measures Arms Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Arm 1: Experimental - ianalumab Intervention Arm 2: Placebo comparator Target Patients Patients with active Sjogren's syndrome Readout Milestone(s) Primary 2026 Publication TBD NOVARTIS | Reimagining Medicine#57Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology ianalumab - BAFF-R inhibitor Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology ianalumab - BAFF-R inhibitor References Abbreviations Other Indication NCT05639114 SIRIUS-SLE 1 (CVAY736F12301) Systemic lupus erythematosus Indication Phase Phase 3 Phase NCT05624749 SIRIUS-SLE 2 (CVAY736F12302) Systemic lupus erythematosus Phase 3 Patients 406 Patients 280 Primary Outcome Proportion of participants on monthly ianalumab achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) [ Time Frame: Week 60] Measures Primary Outcome Measures Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) [ Time Frame: Week 60 ] Arms Intervention Experimental: lanalumab s.c. monthly Experimental: lanalumab s.c. quarterly Placebo Comparator: Placebo s.c. monthly Arms Experimental: ianalumab s.c. monthly Intervention Placebo Comparator: placebo s.c. monthly Target Patients Patients with active systemic lupus erythematosus (SLE) Target Patients with active systemic lupus erythematosus (SLE) Patients Readout Milestone(s) 2027 Publication TBD 57 Investor Relations | Q3 2023 Results Readout Milestone(s) 2027 Publication TBD NOVARTIS | Reimagining Medicine#58Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology ligelizumab-IgE Inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology NCT04984876 (CQGE031G12301) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Food allergy Phase 3 211 1. Proportion of participants who can tolerate a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 Arm 1: ligelizumab 240 mg subcutaneous injection for 52 weeks Arm 2: ligelizumab 120 mg subcutaneous injection for 52 weeks Arm 3: Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks Arm 4: Placebo 16 weeks and ligelizumab 120 mg/240 mg subcutaneous injection for 36 weeks Arm 5: Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks Participants with a medically confirmed diagnosis of IgE-mediated peanut allergy Readout Milestone(s) 2023 Publication TBD 58 Investor Relations | Q3 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#59Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology LNA043-ANGPTL3 agonist Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology NCT04864392 ONWARDS (CLNA043A12202) Knee osteoarthritis Phase 2 Indication Phase Patients 550 Primary Outcome Measures Arms Intervention Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging LNA043 injection to the knee with dosing regimen A LNA043 injection to the knee with dosing regimen B LNA043 injection to the knee with dosing regimen C LNA043 injection to the knee with dosing regimen D Placebo injection to the knee Patients with Symptomatic knee osteoarthritis Target Patients Readout Milestone(s) Primary 2024 Publication TBD References Abbreviations Other 59 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#60Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology remibrutinib - BTK inhibitor NCT05030311 REMIX-1 (CLOU064A2301) Chronic spontaneous urticaria Phase 3 Indication Phase Patients 470 Primary Outcome Appendix Innovation: Clinical trials Neuroscience Oncology Measures Arms Intervention 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 Target Patients Readout Milestone(s) 2024 (Final) Publication TBD 60 Investor Relations | Q3 2023 Results remibrutinib - BTK inhibitor References Abbreviations Other NCT05032157 REMIX-2 (CLOU064A2302) Chronic spontaneous urticaria Phase 3 Indication Phase Patients 455 Primary Outcome Measures Arms Intervention Target Patients 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) Readout Milestone(s) Publication TBD 1 NOVARTIS | Reimagining Medicine#61Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology remibrutinib - BTK inhibitor NCT05030311 REMIX-1 (CLOU064A2301) Indication Phase Chronic inducible urticaria Phase 3 Patients Primary Outcome Measures Arms Intervention Target Patients 348 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 Readout Milestone(s) 2026 Publication TBD 61 Investor Relations | Q3 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#62Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 62 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#63Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology MayzentⓇ - S1P1,5 receptor modulator NCT04926818 NEOS (CBAF312D2301) Indication Phase Multiple sclerosis, pediatrics Phase 3 Patients 180 Primary Outcome Annualized relapse rate (ARR) in target pediatric participants Conclusions Neuroscience Measures Arms Intervention Target Patients Arm 1: Experimental ofatumumab - 20 mg injection/ placebo Arm 2: Experimental siponimod - 0.5 mg, 1 mg or 2 mg/ placebo Arm 3: Active Comparator fingolimod - 0.5 mg or 0.25 mg/ placebo Children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The targeted enrollment is 180 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years. 2026 Readout Milestone(s) Publication TBD 63 Investor Relations | Q3 2023 Results Appendix Innovation: Clinical trials Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#64Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology remibrutinib - BTK inhibitor Conclusions Indication Phase NCT05147220 REMODEL-1 (CLOU064C12301) Multiple sclerosis Phase 3 Patients 800 Primary Outcome Measures Annualized relapse rate (ARR) of confirmed relapses [Core Part]. ARR is the average number of confirmed MS relapses in a year Arms Intervention 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) Appendix Innovation: Clinical trials Neuroscience Oncology Target Patients Readout Milestone(s) 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 Publication TBD 64 Investor Relations | Q3 2023 Results remibrutinib - BTK inhibitor NCT05156281 REMODEL-2 (CLOU064C12302) Multiple sclerosis Phase 3 Indication Phase Patients 800 Primary Outcome References Annualized relapse rate (ARR) of confirmed relapses Abbreviations Other Measures Arms Intervention Target Patients 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 NOVARTIS | Reimagining Medicine#65Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other ZolgensmaⓇ - SMN1 gene replacement therapy ZolgensmaⓇ - SMN1 gene replacement therapy NCT05089656 STEER (COAV101B12301) Indication Spinal muscular atrophy (IT administration) Phase 3 Phase Patients 125 Primary Outcome Measures Arms Intervention Target 1. Change from baseline in Hammersmith functional motor scale - Expanded (HFMSE) total score at the end of follow-up period 1 in treated patients compared to sham controls in the ≥ 2 to < 18 years age group Arm 1: Experimental OAV101. Administered as a single, one-time intrathecal dose Arm 2: Sham Comparator: Sham control. A skin prick in the lumbar region without any medication. Patients Type 2 Spinal Muscular Atrophy (SMA) who are ≥ 2 to < 18 years of age, treatment naive, sitting, and never ambulatory Patients Readout Milestone(s) 2024 Publication TBD 65 Investor Relations | Q3 2023 Results NCT05386680 STRENGTH (COAV101B12302) Indication Phase Spinal muscular atrophy (IT administration) Phase 3B Patients 28 Primary Outcome Measures Arms Intervention Number and percentage of participants reporting AEs, related AES, SAES, and AESIS [ Time Frame: 52 weeks ] Experimental: OAV-101 Single intrathecal administration of OAV101 at a dose of 1.2 x 10^14 vector genomes Participants with SMA who discontinued treatment With Nusinersen or Risdiplam (STRENGTH) Target Patients Readout Milestone(s) 2024 Publication TBD NOVARTIS | Reimagining Medicine#66Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Oncology Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 66 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#67Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology ianalumab - BAFF-R inhibitor NCT05653349 VAYHIT1 (CVAY736112301) Indication Phase Patients Primary Outcome Measures Arms 1L Immune Thrombocytopenia Phase 3 225 Time from randomization to treatment failure (TTF) Appendix Innovation: Clinical trials Neuroscience Oncology Intervention Arm 1: Experimental: lanalumab Lower dose administered intravenously with corticosteroids oral or parentally (if clinically justified) Arm 2: lanalumab Higher dose administered intravenously with corticosteroids oral or parentally (if clinically justified) Arm 3: Placebo Comparator administered intravenously with corticosteroids oral or parentally (if clinically justified) Adult patients with primary ITP Target Patients Readout Milestone(s) 2025 Publication TBD 67 Investor Relations | Q3 2023 Results ianalumab - BAFF-R inhibitor References Abbreviations Other NCT05653219 VAYHIT2 (CVAY736Q12301) Indication Phase Patients Primary Outcome Measures Arms Intervention 2L Immune Thrombocytopenia Phase 3 150 Time from randomization to treatment failure (TTF) Arm 1: Experimental: eltrombopag and ianalumab lower dose Arm 2: Experimental: eltrombopag and ianalumab higher dose Arm 3: eltrombopag and placebo Primary ITP patients who failed steroids Target Patients Readout Milestone(s) Publication 2025 TBD NOVARTIS | Reimagining Medicine#68Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology ianalumab - BAFF-R inhibitor Conclusions NCT05648968 VAYHIA (CVAY736012301) Warm autoimmune hemolytic anemia Phase 3 Indication Phase Patients 90 Primary Outcome Measures Arms Intervention Target Patients Binary variable indicating whether a patient achieves a durable response Durable response: hemoglobin level ≥10 g/dL and ≥2 g/dL increase from baseline, for a period of at least eight consecutive weeks between W9 and W25, in the absence of rescue medication or prohibited treatment Arm 1: experimental lanalumab low dose (intravenously) Arm 2: experimental lanalumab high dose (intravenously) Arm 3: placebo Comparatorn (intravenously) Previously treated patients with warm Autoimmune Hemolytic Anemia Readout Milestone(s) Publication 2026 TBD 68 Investor Relations | Q3 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#69Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology iptacopan - CFB inhibitor NCT04889430 APPELHUS (CLNP023F12301) Atypical haemolytic uraemic syndrome Indication Phase Phase 3 Patients 50 Primary Outcome Measures Arms Intervention Target Patients Percentage of participants with complete TMA response without the use of PE/PI and anti-C5 antibody Single arm open-label with 50 adult patients receiving 200mg oral twice daily doses of iptacopan Adult patients with aHUS who are treatment naive to complement inhibitor therapy (including anti-C5 antibody) Readout Milestone(s) 2025 Publication TBD Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 69 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#70Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology JakaviⓇ - JAK1/2 inhibitor NCT03491215 REACH4 (CINC424F12201) Indication Acute graft versus host disease Phase 2 Phase Patients 45 Primary Measurement of PK parameters Outcome Measures Overall Response Rate (ORR) Arms Ruxolitinib Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology Intervention Pediatric patients with grade II-IV acute graft vs. host disease after allogeneic hematopoietic stem cell transplantation Target Patients Readout 2023 Milestone(s) Publication TBD 70 Investor Relations | Q3 2023 Results JakaviⓇ- JAK1/2 inhibitor References Abbreviations Other Indication Phase NCT03774082 REACH5 (CINC424G12201) Chronic graft versus host disease Phase 2 Patients 45 Primary Overall Response Rate (ORR) Outcome Measures Arms Intervention Target Patients Ruxolitinib 5mg tablets / pediatric formulation Pediatric subjects with moderate and severe chronic Graft vs. Host disease after allogeneic stem cell transplantation Readout Milestone(s) Publication 2023 TBD NOVARTIS | Reimagining Medicine#71Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology opnurasib - KRAS inhibitor NCT05132075 KontRASt-02 (CJDQ443B12301) Indication Non-small cell lung cancer, 2/3L Phase Phase 3 Patients 360 Primary Progression free survival (PFS) Outcome Appendix Innovation: Clinical trials Neuroscience Oncology Measures Arms Intervention Target Patients Arm 1 Experimental: JDQ443 Arm 2 Active Comparator: Participant will be treated with docetaxel following local guidelines as per standard of care and product labels Patients with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination. Readout Milestone(s) Publication 2024 NA 71 Investor Relations | Q3 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#72Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations PluvictoⓇ - Radioligand therapy target PSMA PluvictoⓇ - Radioligand therapy target PSMA NCT04689828 PSMAfore (CAAA617B12302) NCT04720157 PSMAddition (CAAA617C12301) Metastatic hormone sensitive prostate cancer Indication Metastatic castration-resistant prostate cancer, pre-taxane Indication Phase Phase 3 Phase Phase 3 Patients 450 Patients 1126 Primary Radiographic Progression Free Survival (rPFS) Primary Outcome Outcome Measures Measures Arms Arms Intervention Intervention 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 Target Patients Readout Milestone(s) Publication H2 2023 Primary Analysis: 2022 (actual) Final Analysis: 2025 72 Investor Relations | Q3 2023 Results Radiographic Progression Free Survival (rPFS) Other Arm 1: 177Lu-PSMA-617 Participant will receive 7.4 GBq (+/- 10%) 177 Lu-PSMA- 617, once every 6 weeks for a planned 6 cycles, in addition to the Standard of Care (SOC); ARDT +ADT is considered as SOC and treatment will be administered per the physician's order Arm 2: For participants randomized to Standard of Care arm, ARDT +ADT is considered as SOC and treatment will be administered per the physician's order Patients with metastatic Hormone Sensitive Prostate Cancer (mHSPC) Target Patients Readout Milestone(s) Publication Primary Analysis: 2024 TBD NOVARTIS | Reimagining Medicine#73Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology RydaptⓇ - Multi-targeted kinase inhibitor NCT03591510 (CPKC412A2218) Indication Acute myeloid leukemia, pediatrics Phase 2 Conclusions Neuroscience Phase Patients 20 Primary Outcome Measures Arms Intervention Target Patients Occurrence of dose limiting toxicities Safety and Tolerability Chemotherapy followed by Midostaurin Newly diagnosed pediatric patients with FLT3 mutated acute myeloid leukemia (AML) Readout 2026 Milestone(s) Publication TBD Appendix Innovation: Clinical trials Oncology References Abbreviations Other 73 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#74Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology sabatolimab - TIM3 antagonist Conclusions NCT04150029 STIMULUS-AML1 (CMBG453C12201) Unfit acute myeloid leukaemia Phase 2 Indication Phase Patients 86 Primary Outcome Measures Arms Intervention Target Patients Incidence of dose limiting toxicities (Safety run-in patients only) Percentage of subjects achieving complete remission (CR) Single arm safety and efficacy study of sabatolimab in combination with azacitidine and venetoclax Newly diagnosed adult AML patients who are not suitable for treatment with intensive chemotherapy Readout Milestone(s) 2023 Publication TBD 74 Investor Relations | Q3 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology sabatolimab - TIM3 antagonist NCT04266301 STIMULUS-MDS2 (CMBG453B12301) Indication Phase Myelodysplastic syndrome Phase 3 Patients 500 Primary Overall survival Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Publication TBD References Abbreviations Other Sabatolimab 800 mg + azacitidine 75 mg/m2 Sabatolimab 800 mg + azacitidine 75 mg/m2 + placebo Patients with intermediate, high or very high risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) 2024 NOVARTIS | Reimagining Medicine#75Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology ScemblixⓇ - BCR-ABL inhibitor NCT04971226 ASC4FIRST (CABL001J12301) Chronic myeloid leukemia, 1st line Phase 3 Indication Phase Patients 402 Primary Outcome Measures Arms Major Molecular Response (MMR) at week 48 Intervention Arm 1: asciminib 80 mg QD Arm 2: Investigator selected TKI including one of the below treatments: - Imatinib 400 mg QD Target Patients - 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 Publication TBD 75 Investor Relations | Q3 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#76Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology TNO155-SHP2 inhibitor NCT03114319 (CTNO155X2101) Solid tumors (single agent) Phase 1 Indication Phase Patients 255 Primary Outcome Measures Arms Intervention Target Patients Number of participants with adverse events Number of participants with dose limiting toxicities Drug: TNO155 Drug: TNO155 in combination with EGF816 (nazartinib) Adult patients with advanced solid tumors in selected indications Readout Milestone(s) 2024 Publication TBD Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 76 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#77Company overview Innovation: Pipeline overview Cardiovascular Other Financial review Conclusions Financial performance Immunology Neuroscience Ophthalmology Appendix Innovation: Clinical trials Oncology Global Health References Abbreviations Other 77 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine#78Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Neuroscience Ophthalmology Ophthalmology Appendix Innovation: Clinical trials Oncology Global Health References Abbreviations Other 78 Investor Relations | Q3 2023 Results 1 NOVARTIS | Reimagining Medicine#79Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience Ophthalmology BeovuⓇ - VEGF Inhibitor NCT04278417 CONDOR (CRTH258D2301) Indication Diabetic retinopathy Phase 3 Change from Baseline in BCVA Phase Patients 694 Primary Outcome Measures Arms Intervention 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 Target Patients Readout Milestone(s) 2024 Publication TBD Appendix Innovation: Clinical trials Oncology Global Health References Abbreviations Other 79 Investor Relations | Q3 2023 Results 1 NOVARTIS | Reimagining Medicine#80Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Ophthalmology Global Health Conclusions Neuroscience Appendix Innovation: Clinical trials Oncology Global Health References Abbreviations Other 80 Investor Relations | Q3 2023 Results 1 NOVARTIS | Reimagining Medicine#81Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience Ophthalmology Adakveo® - P-selectin inhibitor NCT03474965 SOLACE-Kids (CSEG101B2201) Indication Sickle cell disease, pediatrics Phase 2 PK/PD and safety of SEG101 at 5 mg/kg Phase Patients 100 Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Publication SEG101 (crizanlizumab) at a dose of 5 mg/kg by IV infusion + Hydroxyurea/Hydroxycarbamide Pediatric SCD patients with VOC H2-2021 (pediatric patients ≥12 year old) 2024 (pediatric patients <12 year old) 1. Matthew M. Heeney, David C. Rees, Mariane de Montalembert, Isaac Odame, R. Clark Brown, Yasser Wali, Thu Thuy Nguyen, Du Lam, Raquel Merino Herranz, Julie Kanter; Study Design and Initial Baseline Characteristics in Solace- Kids: Crizanlizumab in Pediatric Patients with Sickle Cell Disease. Blood 2020; 136 (Supplement 1): 22-24. doi: https://doi.org/10.1182/blood-2020-137081 2. Matthew M. Heeney, David C. Rees, Mariane De Montalembert, Isaac Odame, R. Clark Clark Brown, Yasser Wali, Thu Thuy Nguyen, Du Lam, Nadege Pfender, Julie Kanter; Initial Safety and Efficacy Results from the Phase II, Multicenter, Open-Label Solace-Kids Trial of Crizanlizumab in Adolescents with Sickle Cell Disease (SCD). Blood 2021; 138 (Supplement 1): 12. doi: https://doi.org/10.1182/blood-2021-144730 81 Investor Relations | Q3 2023 Results Appendix Innovation: Clinical trials Oncology Global Health References Abbreviations Other 1 NOVARTIS | Reimagining Medicine#82Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Ophthalmology cipargamin - PfATP4 inhibitor Conclusions NCT04675931 KARISMA (CKAE609B12201) Malaria severe Phase 2 Indication Phase Patients 252 Primary Outcome Measures Arms Intervention Percentage of participants achieving at least 90% reduction in Plasmodium falciparum (P. falciparum) at 12 hours [ Time Frame: Day 1 (12 Hours) ] Arm 1: experimental, IV KAE609 Dose regimen 1 Arm 2: experimental, IV KAE609 Dose regimen 2 Arm 3: experimental, IV KAE609 Dose regimen 3 Arm 4: active comparator, IV Artesunate Arm 5: Coartem, Standard of care Patients with Malaria, severe Target Patients Readout Milestone(s) 2025 Publication TBD Neuroscience Appendix Innovation: Clinical trials Oncology Global Health References Abbreviations Other 82 Investor Relations | Q3 2023 Results 1 NOVARTIS | Reimagining Medicine#83Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience Ophthalmology CoartemⓇ - PGH-1 (artemisinin combination therapy) NCT04300309 CALINA (CCOA566B2307) Malaria, uncomplicated (<5kg patients) Phase 3 Indication Phase Patients 44 Primary Artemether Cmax Outcome Measures Arms Intervention Target Patients Experimental: artemether lumefantrine (2.5 mg:30 mg) artemether lumefantrine (2.5 mg:30 mg) bid over 3 days, from 1-4 tablets per dose Infants and Neonates <5 kg body weight with acute uncomplicated plasmodium falciparum malaria 2024 Readout Milestone(s) Publication TBD Appendix Innovation: Clinical trials Oncology Global Health References Abbreviations Other 83 Investor Relations | Q3 2023 Results 1 NOVARTIS | Reimagining Medicine#84Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience Ophthalmology ganaplacide - Non-artemisinin plasmodium falciparum inhibitor NCT04546633 KALUMI (CKAF156A2203) Indication Malaria, uncomplicated Phase 2 Phase Patients 292 Primary Outcome Measures Arms Intervention Target Patients PCR-corrected and uncorrected Adequate Clinical and Parasitological Response (ACPR) KAF156 and LUM-SDF QD (once daily) for 2 days in fasted condition KAF156 and LUM-SDF QD (once daily) for 2 days in fed condition Malaria patients 6 months to < 18 years old Readout Milestone(s) Publication 2024 TBD 84 Investor Relations | Q3 2023 Results Appendix Innovation: Clinical trials Oncology Global Health References Abbreviations Other 1 NOVARTIS | Reimagining Medicine#85Company overview Innovation: Pipeline overview Abbreviations Financial review Financial performance Conclusions Appendix Innovation: Clinical trials References Abbreviations ΑΙ АІН aHUS ALL ALS AML Auto-injector Autoimmune hepatitis atypical Hemolytic Uremic Syndrome Acute lymphoblastic leukemia Amyotrophic lateral sclerosis Acute myeloid leukemia IgAN IPF ITP LBCL BC Breast cancer LN mCRPC MDS IgA nephropathy Idiopathic pulmonary fibrosis Immune thrombocytopenia Large B-cell lymphoma Lupus nephritis Metastatic castration-resistant prostate cancer Myelodysplastic syndrome C3G C3 glomerulopathy MHSPC Metastatic hormone sensitive prostate cancer CART Chimeric androgen receptor T mPDAC Metastatic pancreatic ductal adenocarcinoma CLL Chronic lymphocytic leukemia CML Chronic myeloid leukemia MS NASH Multiple sclerosis CRC Colorectal cancer nmCRPC COPD Chronic obstructive pulmonary disease NPR1 COSP Chronic ocular surface pain nr-axSpA CSU Chronic spontaneous urticaria NSAI CVRR-Lp(a) CVRR-LDLC DME Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a) Secondary prevention of cardiovascular events in patients with elevated levels of LDLC Diabetic macular edema NSCLC Non-alcoholic steatohepatitis Non-metastatic castration-resistant prostate cancer Natriuretic peptide receptor 1 Non-radiographic axial spondyloarthritis Non-steroidal aromatase inhibitor Non-small cell lung cancer OS Overall survival PFS Prefilled syringe DLBCL Diffuse large B-cell lymphoma refractory PNH Paroxysmal nocturnal haemoglobinuria ESCC FL GCA GVHD GRPR HCC HD Esophageal squamous-cell carcinoma Follicular lymphoma Giant cell arteritis Graft-versus-host disease Gastrin releasing peptide receptor Hepatocellular carcinoma Huntington's disease PsA Psoriatic arthritis rHR Resistant hypertension rMS rPFS SLE Relapsing multiple sclerosis Radiographic progression free survival Systemic lupus erythematosus SMA Type 1 Spinal muscular atrophy (IV formulation) HR LBCL High risk large B-cell lymphoma SpA IA Interim analysis T1DM SMA Type 2/3 Spinal muscular atrophy (IT formulation) Spondyloarthritis Type 1 Diabetes mellitus iAMD Intermediate age-related macular degeneration WAIHA Warm autoimmune hemolytic anemia IC-MPGN Immune complex membranoproliferative glomerulonephritis 85 Investor Relations | Q3 2023 Results U NOVARTIS | Reimagining Medicine#86Company overview Financial review Conclusions Appendix References References EntrestoⓇ 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. AHA/ACC/HFSA/ESC. 3 4 Extension of regulatory data protection to November 2026 in EU based on approval of pediatric indication. 5 For forecasting purposes, we assume no generic entry before 2025. KesimptaⓇ 1 Sept. 2023 numbers are estimated using weekly data through September 22, 2023, IQVIA NPA (KesimptaⓇ) and IQVIA NPA adjusted by NSP (all others). B-cell therapies as portion of MS market in NBRx. 2 Data on file. 3 The initial dosing period consists of 20 mg subcutaneous doses at Weeks 0, 1 and 2, thereafter once a month. Patient must take pen out of the refrigerator 15-30 minutes before self-administering. 4 Efficacy outcomes as measured by disability progression and brain volume change. 5 Cohen et al, Poster presented at American Academy of Neurology, Boston, 22-27 April 23. 6 Cohen et al, oral presentation at American Academy of Neurology, Boston, 22-27 April 23. 86 Investor Relations | Q3 2023 Results NOVARTIS | Reimagining Medicine

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

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

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

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare