Reimagining Medicine

Made public by

sourced by PitchSend

11 of 97

Creator

Novartis logo
Novartis

Category

Healthcare

Published

Q2 2023

Slides

Transcriptions

#1Company overview Financial review Conclusions Appendix References Q2 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, including the acquisitions of Chinook Therapeutics or DTX Pharma, or our divestiture of 'front of eye' ophthalmology assets; or regarding potential future sales or earnings of the Group or any of its divisions; or regarding discussions of strategy, priorities, plans, expectations or intentions, including our transforming into a "pure-play" Innovative Medicines business; or regarding the Group's liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our planned spin-off of Sandoz; or regarding the new share buyback; or regarding the impact of the 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. Chinook Therapeutics and Chinook are registered trademarks of Chinook Therapeutics, Inc. DTX Pharma is a registered trademark of DTX Pharma, Inc. BAUSCH + LOMB is a registered trademark of Bausch & Lomb Incorporated. 2 Investor Relations | Q2 2023 Results U NOVARTIS | Reimagining Medicine#3Company overview Financial review Conclusions Appendix References Vas Narasimhan, M.D. Chief Executive Officer Company overview 3 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#4Company overview Financial review Conclusions Appendix References Novartis delivers strong sales growth, robust margin expansion and raises guidance Q2 SUMMARY Growth and Productivity Q2, % cc Core margin 39.0% (+340 bps) +20% +17% +9% +9% +8% +6% Sales Core Oplnc Sales Core Oplnc Sales Group IM Core Oplnc Sandoz FY 2023 Group guidance raised¹ Sales expected grow high single digit Core Oplnc expected to grow low double digit Innovation and other milestones KisqaliⓇ NATALEE Ph3 at ASCO Cosentyx® US approval 300mg Al and PFS; EU approval in HS EntrestoⓇ EU approval in pediatric HF, extending RDP to Nov 2026 Iptacopan US and EU filings in PNH; US BTD for C3G Continue strategic rationalization of development portfolio including Chinook acquisition, divestment of front of eye assets and termination of BeiGene option agreement for ociperlimab EntrestoⓇ US IP update Mylan held to infringe crystalline complex patents; Novartis disagrees with negative decision by Delaware Court and will appeal to uphold validity of combination patent 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. IM - Innovative Medicines division. RDP Regulatory data protection. HF-heart failure. HS Hidradenitis suppurativa. BTD Breakthrough therapy designation. 1. Assumes no US EntrestoⓇ Gx at risk launch in 2023. 4 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#5Company overview Financial review Conclusions Appendix References Q2 growth driven by strong performance from EntrestoⓇ, KesimptaⓇ, PluvictoⓇ and KisqaliⓇ Q2 sales Entresto Sales USD million Growth vs. PY USD million 1,516 sacubitri/valsartan Kesimpta 489 (ofatumumab) 240 PLUVICTO™ KISQALI 493 185 ribociclib Ⓒ SCEMBLIX® 106 75 (asciminib) LEQVIO® 78 56 150 64 A LUTATHERA PROMACTA 583 49 (eltrombopag) X PIQRAY 130 45 (alpelisib) tablets Tafinlar. + Mekinist. 496 44 ILARIS (canakinumab) 316 41 230 391 250 Growth vs. PY CC 37% GROWTH 105% nm Strong growth (+71% cc); 66% expected to continue 248% 249% 75% 11% 54% 13% 17% 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. nm not meaningful. 5 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#6Company overview Financial review Conclusions Appendix References EntrestoⓇ delivering strong double-digit growth in all geographies Sales evolution USD m, % cc US weekly TRX1 Total prescriptions (000) 110 Ex-US US 100 +37% 90 1,516 80 200 70 1,125 761 60 50 577 40 30 755 20 548 210 10 0 Q2 2022 Q2 2023 July 2015 June 2023 GROWTH Entresto® Strong Q2 momentum US: sales +38% cc, NBRx +17% vs PY, ~1.3m TRx in Q21 Ex-US: sales +36% cc, continued strong growth in HFrEF China/Japan: Significant contribution from HTN² Confidence in future growth Robust guidelines³ (US/EU) Expect further penetration in HFrEF (2/3 eligible patients still on prior SoC) PARAGLIDE in HFPEF met primary endpoint5 Pediatric approval confirms RDP to Nov 2026 EU4 US IP update Mylan held to infringe crystalline complex patents; Novartis disagrees with negative decision by Delaware Court and will appeal to uphold validity of combination patent TRX total prescriptions. See last page for references. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. HFPEF-heart failure with preserved ejection fraction. HFrEF-heart failure with reduced ejection fraction. HF heart failure. HTN hypertension. RDP Regulatory data protection. SOC 6 Investor Relations | Q2 2023 Results NBRX-new to brand prescriptions. standard of care. ✓ NOVARTIS | Reimagining Medicine#7Company overview Financial review Conclusions Appendix References CosentyxⓇ sales stabilized; expecting growth in H2 Sales evolution USD m, % cc Ex-US US +1% 1,275 1,272 539 622 736 650 Q2 2022 Q2 2023 GROWTH Cosentyx® Q2 performance US sales (-12% cc): Volume growth offset by revenue deductions (incl. PY base impact) Ex-US sales (+18% cc): Strong growth in core indications China: Outperforming market with double-digit growth post-COVID Expect growth in H2 EU: HS approved in Q2 US: HS and Rheum IV approvals expected H2 US: 300mg autoinjector approved LCM program 3 Ph3 studies ongoing: Giant Cell Arteritis, Polymyalgia Rheumatica, Rotator Cuff Tendinopathy; termination of lupus nephritis 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. 7 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#8Company overview Financial review Conclusions Appendix References KisqaliⓇ continued strong momentum globally, with increasing recognition of its differentiated profile GROWTH Sales evolution USD m, % cc Ex-US US +66% 493 308 269 US MBC NBRx share1 Rolling 3 months, % 198 15% 224 110 Q2 2022 Q2 2023 May 2022 Consistent efficacy KISQALI Kisqali Ph3 OS results in 1L mBC2 34% Stage IV HR 95% CI MONALEESA-2 0.76 (0.63, 0.93) MONALEESA-7 0.76 (0.61, 0.96) May 2023 MONALEESA-3 0.67 (0.50, 0.90) Consistent benefit regardless of combination endocrine therapy, menopausal status, or site and number of metastases Included in NCCN guidelines³ as the only Category 1 treatment for 1L mBC with Al 1. Of CDK4/6 mBC market, US 3 months ending May 2023 from IQVIA Breast Cancer mBC metastatic breast cancer. NBRX-new to brand prescription. NCCN - national comprehensive cancer network. Al aromatase inhibitor. Market Sizing report. 2. MONALEESA-2: Hortobagyi et al, NEJM 2022; MONALEESA-7: Lu et al, Clin Cancer Res 2022; MONALEESA-3: Neven et al, ESMO Breast 2022. 3. NCCN Guidelines updated as of 27-Jan-2023. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. 8 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#9Company overview Financial review Conclusions Appendix References INNOVATION NATALEE results¹ build on Kisqali's differentiated efficacy in mBC, support expansion into broad population² of stage II, III eBC patients Ph3 NATALEE trial results 1,2, presented at ASCO 2023 Robust efficacy Favorable safety No new safety signals 400mg dose well tolerated, with limited need for dose reductions HR iDFS - total population 0.75 95% CI (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) Low rates of Gr3 symptomatic AEs OS 0.76 (0.54, 1.07) - AE-related discontinuations (<19%) were mostly protocol-mandated due to lab findings - most frequent AEs were neutropenia and liver-related 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. Pending regulatory review and approval. 9 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#10Company overview Financial review Conclusions Appendix References Next steps for KisqaliⓇ Continued momentum in mBC, with increasing market share and NATALEE updated analysis for iDFS and OS expected H2 2023 prescriber adoption INNOVATION Expected filing in EU and US Q3/Q4 2023 Pursuing broad label reflecting the ITT population studied in NATALEE Collectively, NATALEE results¹ have the potential to more than double the number of patients² who could benefit from treatment with a CDK4/6 inhibitor in the eBC setting ITT Intent to treat. 1. Interim analysis. 2. Pending regulatory review and approval. 10 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#11Company overview Financial review Conclusions Appendix References GROWTH KesimptaⓇ continues strong launch trajectory doubling sales vs. PY Kesimpta Sales evolution USD m, % cc Ex-US US US NBRx1 Rolling 4 weeks 350 300 +105% 250 489 116 200 150 239 100 373 204 60 50 0 Q2 2022 Q2 2023 Sept 2020 June 2023 Global sales US: Growing faster than market1,2 TRX +80% YTD vs. PY (market flat) NBRX +43% vs. PY (market +1%) B-cell NBRX share -54% of MS market Europe: Strong launch momentum³ >24k patients treated, thereof >1/3 naive patients Confident in future growth Significant room to grow About a third of patients with MS on B-Cell therapy 1,2 Compelling product profile 1 minute a month dosing from home/anywhere³; 5-year efficacy and safety data 5,6 See last page for references. TRX total prescriptions. NBRX-new to brand prescription. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. 11 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#12Company overview Financial review Conclusions Appendix References PluvictoⓇ continued strong performance with improving supply Sales evolution Global sales, USD m 80 00 Strong progress in Q2 GROWTH P PLUVICTO™ 240 Q2 sales of USD 240m, +14% USD vs. Q1 211 179 Millburn (US) and Zaragoza (EU) sites approved for commercial Pluvicto supply in April, continuing to ramp up gradually Actively starting new patients and onboarding new centers Ex-US reimbursement discussions ongoing Upcoming milestones PSMAfore pre-taxane data presentation and filing expected in H2 Submission and approval of Indianapolis site (US) 10 2 Q1 Q2 Q3 Q4 Q1 2022 2023 Q2 mCRPC metastatic castration-resistant prostate cancer. rPFS radiographic progression free survival. OS overall survival. 12 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#13Company overview Financial review Conclusions Appendix References LeqvioⓇ adoption expanding as we progress the launch LeqvioⓇ launch progressing steadily Global sales evolution USD m Ex-US US 22 22 42 34 64 19 Building foundation for acceleration US adoption 2,600 facilities have ordered Leqvio (+18% vs. Q1) 78 Buy & bill 54% of Leqvio demand (+16% vs. Q1) Q2 2022 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Early adopters driving Leqvio depth Clinical profile Consistent safety vs. Ph3 studies beyond 5yr follow-up in pooled analysis across 7 clinical trials1 Label expansion in US: indication updated to ☐ Primary hyperlipidemia incl. HeFH Less restrictive language for use for statin therapy Removal of several adverse reactions from safety section GROWTH HCP healthcare professional. LTD - Launch To Date. *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 Pharmaceuticals 1. Wright RS. Oral presentation at: American College of Cardiology Annual Conference; March 2023. 13 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#14Company overview Financial review Conclusions Appendix References ScemblixⓇ strong sales growth driven by underlying demand and increasing recognition of efficacy and tolerability benefit GROWTH Sales evolution USD m Ex-US US SCEMBLIX® (asciminib) 20 mg, 40 mg tablets 106 Q2 sales reflect strong demand from CML patients resistant or intolerant to 2 or more prior TKIs US new patient share in 3L+ at 35%¹; average # of monthly prescribers +16% vs. Q1 2023 Global rollout ongoing with strong performance in Germany & Japan Despite available therapies (1st and 2nd generation TKIs), strong unmet need remains in CML2 ASC4FIRST (1L registrational study) completed enrollment, readout and filing expected 2024 28 76 15 52 41 10 31 4 78 61 37 42 29 Q2 Q3 Q4 Q1 Q2 2022 2023 1. IQVIA: US April 2023 rolling three months 3L+ new patient start share. 2. Survey on unmet needs in CML at EHA: reveals the need for treatment decisions that balance quality of life, efficacy, and tolerability goals; Chronic Myeloid Leukemia Survey on Unmet Needs (CML SUN). 14 Investor Relations | Q2 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), further Primary endpoint met at interim analysis follow up data on track for H2 2023 EMA and FDA regulatory submission PluvictoⓇ PSMAfore trial in mCRPC (post-ARDT, pre-taxane) positive readout; detailed data presentation planned in Q4 2023 FDA regulatory submission planned in Q4 2023 Iptacopan PNH filed with FDA and EMA in Q2 2023 APPLAUSE-IgAN Ph3 readout² planned in Q4 2023 APPEAR-C3G Ph3 readout planned in Q4 2023 expected Q3/Q4 2023 *Unprobabilized peak sales of all asset indications in late-stage development: > USD 1bn > USD 2bn > USD 3bn mCRPC metastatic castration resistant prostate cancer. ARDT-androgen receptor directed therapy. 1. Based on AJCC prognostic staging. 2. 9 months analysis potentially supporting US Subpart H filing. 15 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#16Company overview Financial review Conclusions Appendix References Submission enabling readouts expected to increase in 2024-2025 timeframe Selected key assets* with submission enabling readouts in 2024-2025 Remibrutinib CSU Primary analysis¹ in H2 2023 Final (52 weeks) readout and submission in 2024 ScemblixⓇ 1L CML-CP Readout and submission in 2024 PluvictoⓇ MHSPC Readout and submission in 20242 OAV-101 SMA IT Readout in 2024; submission in 2025 Pelacarsen CVRR Readout and submission in 2025 lanalumab 1L and 2L ITP readouts in 2025 with submission in 2026 Additional hematology and immunology indications 2026+ Iptacopan Additional readouts/submissions in 2025/2026+ INNOVATION *Unprobabilized peak sales of all asset indications in late-stage development: > USD 1bn > USD 2bn > 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 study endpoint. SMA IT-spinal muscular atrophy intrathecal. CVRR-cardiovascular risk 16 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#17Company overview Financial review Conclusions Appendix References STRATEGY Recent deals to bolster pipeline and strengthen technology platforms including late stage assets in IgAN, early stage asset in CNS Announced acquisitions (selected) Clinical stage: IgAN1 CHINOOK™ THERAPEUTICS Atrasentan, Ph3 oral ERA, pivotal readout expected Q4 2023 Zigakibart, SC anti-APRIL, expected to enter Ph3 in H2 2023 Both have shown strong proteinuria reduction in Ph2 USD 3.2bn upfront (total consideration up to USD 3.5bn) Announced divestment Neuromuscular + technology Non-core front of eye assets¹ DTX PHARMA Lead early asset DTx1252 for Charcot-Marie-Tooth disease siRNA FALCON platform USD 0.5bn upfront Others Gene Therapy: Avrobio cystinosis program RLT: Ph1/2 FAP-2286 (Clovis Oncology) 1. Subject to customary closing conditions; closing expected H2 2023 APRIL - a proliferation inducing ligand. BAUSCH + LOMB incl. Xiidra, SAF312, OJL332 Supports focus in 5 TAs USD 1.75bn upfront (total consideration up to USD 2.5bn) Termination BeiGene option agreement for ociperlimab ERA endothelin A receptor antagonist. FALCON - fatty acid ligand conjugated oligonucleotides. IgAN - immunoglobulin A nephropathy. 17 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#18Company overview Financial review Conclusions Appendix References Harry Kirsch Chief Financial Officer Financial review and 2023 guidance 18 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#19Company overview Financial review Conclusions Appendix References FINANCIAL PROFILE Very strong H1; Q2 continuing robust top and bottom-line growth... Group¹ USD million Q2 2023 Change vs. PY H1 Change vs. PY % USD % CC 2023 % USD % CC Net Sales 13,622 7 9 26,575 5 8 Core Operating income 4,668 9 17 9,081 9 16 Operating income 2,920 31 50 50 5,776 14 28 Net Income 2,317 37 54 4,611 18 Core EPS (USD) 1.83 17 25 3.54 17 EPS (USD) 1.11 44 62 2.20 24 39 32 25 39 32 25 Free Cash Flow 3,275 -6 5,995 23 1. Core results, constant currencies and free cash flow are non-IFRS measures. Further details regarding non-IFRS measures can be found starting on page 48 of the Condensed Interim Financial Report. 19 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#20Company overview Financial review Conclusions Appendix References contributing to core margin improvements for Group Net sales change vs. PY1 (in % cc) Innovative Medicines 9 Sandoz Q2 2023 Core operating income change vs. PY1 (in % cc) Core margin¹ (%) Core margin change vs. PY1 (%pts cc) Net sales change vs. PY1 (in % cc) 20 39.0 3.4 8 FINANCIAL PROFILE H1 2023 Core operating income change vs. PY1 (in % cc) Core margin¹ (%) Core margin change vs. PY1 (%pts cc) 19 38.9 3.6 8 6 18.0 -0.3 8 5 19.6 -0.5 Group 9 17 34.3 2.5 8 16 34.2 2.4 Novartis ex-Sandoz 9 19 37.7 3.0 8 18 37.4 3.0 1. Constant currencies (cc), core results are non-IFRS measures. An explanation of non-IFRS measures can be found on page 48 of the Condensed Interim Financial Report. 20 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#21Company overview Financial review Conclusions Appendix References Novartis has maintained a consistent approach to its capital allocation priorities; initiating up-to USD 15bn share buyback STRATEGY Investing in the business Investments in organic business¹ USD 43bn of R&D 2018-2022 USD 6bn of CAPEX 2018-2022 Returning to shareholders USD 59bn distributed² 2018-2022 Growing annual dividend in CHF USD 35bn of dividends 2018-2022 USD 7.3bn paid out in Q1-2023 Value-creating bolt-ons USD 30bn (approx.) 2018-2022 Substantial cash generation No rebasing post planned Sandoz spin-off Chinook³, Avrobio4, DTX Pharma acquisition ' Share buybacks (SBB) USD 24bn of buybacks 2018-2022 USD 15bn SBB (announced Dec 2021) completed in June 2023 SBB of up to USD 15bn planned to be completed by end 2025 1. Core R&D and CAPEX actuals 2018-2022. 2. Through dividends and share buybacks. 3. Subject to customary closing conditions; closing expected H2 2023. 4. Acquisition of Avrobio cystinosis program. 21 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#22Company overview Financial review Conclusions Appendix References FINANCIAL PROFILE Raising 2023 guidance for Novartis excluding and including Sandoz Expected, barring unforeseen events; growth vs. PY in cc Innovative Medicines (IM) Novartis ex. Sandoz (IM + Corporate) Novartis incl. Sandoz (IM + Sandoz + Corporate)1 Sales expected to grow high single digit Core Oplnc expected to grow low double digit to mid-teens Sales expected to grow high single digit Core Oplnc expected to grow low double digit to mid-teens Sales expected to grow high single digit Core Oplnc expected to grow low double digit Previous guidance (from mid) (from high single to low double) (from mid) (from high single to low double) (from mid) (from high single) Key assumptions: No US EntrestoⓇ Gx at risk launch in 2023 ☐ No SandostatinⓇ LAR generics enter in the US in 2023 1. Novartis Group guidance, assuming Sandoz would remain within the Group for the entire FY 2023. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. 22 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#23Company overview Financial review Conclusions Appendix References Maintaining Sandoz 2023 guidance Expected, barring unforeseen events; growth vs. PY in cc 2023 Mid-term FINANCIAL PROFILE Sales expected to grow mid single digit Core Oplnc expected to decline low double digit reflecting required stand-up investments to transition Sandoz to a separate company and continued inflationary pressures Sales expected to grow mid single digit Core Oplnc margin expected to expand to mid 20s, continuously progressing from the low 2023 base driven by continued sales growth and operational efficiencies Key assumptions: Sandoz spin-off completed in early Q4 2023 After completion of planned Sandoz spin-off, Core Oplnc guidance will be expressed in terms of core EBITDA. Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. 23 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#24Company overview Financial review Conclusions Appendix References STRATEGY Sandoz has returned to a position of strength; expected spin-off will allow the business more flexibility to pursue its own growth strategy Strengthened Sandoz as a standalone... > Built a strong leadership team with decades of Gx industry experience Expanded pipeline investments 400 Generics and 24 Biosimilars in the pipeline including 4 key launches: adalimumab (approved in EU, launched in US), natalizumab, denosumab, aflibercept Focused on sales execution > Strategic investments in biosimilar capabilities and partnerships including plants in Slovenia and Germany Forged attractive partnerships (e.g. Just-Evotec) to execute on its six strategic levers to drive shareholder value 01 Attractive market fundamentals 04 Margin improvement 02 03 Leadership and scale Multiple growth drivers 05 06 Strong cash flow generation Compelling sustainability story 24 Investor Relations | Q2 2023 Results 1 NOVARTIS | Reimagining Medicine#25Company overview Financial review Conclusions Appendix References Sandoz delivered several consecutive quarters of growth, with a strong Q2 performance and ambitious mid-term outlook STRATEGY Q2 performance¹ Mid-term guidance for standalone Sandoz Sales growth rates¹ in cc +4% +8% +8% FY 2022 Q1 2023 Q2 2023 Sales USD 2.4bn, +8% Biosimilars +13%; Generics +6% Strong ex-US sales growth driven by EU (USD 1.3bn, +13%) Core Oplnc +6% FY 2023 guidance: Sales expected to grow mid single digit; Core Oplnc to decline low double digit Sales1 Mid-single digit CAGR Core EBITDA margin Approximately 24-26% Dividend Policy 30-40% of core net income 1st payment in 2024 for 2023 performance (20-30% of FY core net income) 1. All growth rates in constant currencies (cc). 25 Investor Relations | Q2 2023 Results Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. ✓ NOVARTIS | Reimagining Medicine#26Company overview Financial review Conclusions Appendix References STRATEGY Novartis Board endorses 100% spin-off of Sandoz, which will now go to shareholder vote at EGM in September Key milestones achieved CMDs held in New York and London Roadshows with major shareholders Diverse and experienced Sandoz Board and leadership appointed1 Novartis Board endorses 100% spin-off Next steps August 2023: EGM invitation, Shareholder Brochure and listing prospectus² September 15: Extraordinary General Meeting (EGM), for shareholder vote Early Q4 2023: Spin-off expected upon shareholders approval³ 3. In addition to shareholder approval, completion of the proposed Sandoz spin-off remains subject to certain conditions CMD Capital Markets Day. 1. One Board member still to be announced. 2. Minimum 20 days before EGM. precedent, such as no material adverse events, receipt of necessary authorizations as well as tax rulings and opinions. 26 Investor Relations | Q2 2023 Results ✓ NOVARTIS | Reimagining Medicine#27Company overview Financial review Conclusions Appendix References Vas Narasimhan, M.D. Chief Executive Officer 27 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#28Company overview Financial review Conclusions Appendix References Strong business momentum as we become a focused medicines company Very strong H1 sales growth, robust margin expansion: Broad-based performance across core therapeutic areas and key geographies Confidence in near and mid-term growth: Including rich pipeline, Kisqali®, PluvictoⓇ and iptacopan Raising 2023 FY guidance Initiating up-to USD 15 billion share buyback On track for Sandoz spin-off in early Q4 2023 28 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#29Company overview Innovation: Pipeline overview Financial review Financial performance Appendix Conclusions Appendix Innovation: Clinical trials References Abbreviations 29 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#30Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials References Abbreviations 2023 expected key events; all selected H1 milestones achieved Regulatory decisions Cosentyx® HS CosentyxⓇ 2ml Al Cosentyx® IV LeqvioⓇ Hypercholesterolemia Submissions Iptacopan PNH (US/EU/JP) KisqaliⓇ HR+/HER2-BC (adj) PluvictoⓇ mCRPC, pre-taxane (US) Readouts Kisqali® HR+/HER2- BC (adj) Iptacopan IgAN Ph3 Iptacopan C3G Ph3 Ph3 starts Iptacopan in IC-MPGN Leqvio® CVRR primary prevention lanalumab in immune thrombocytopenia lanalumab in systemic lupus erythematosus INNOVATION H1 2023 H2 2023 Status update - as of end Q2 EU US EU approval in Q2 US US approval in Q2 US JP, China US/EU JP US US NATALEE Ph3 FIR APPLAUSE-IgAN Ph3 APPEAR-C3G Ph3 Filed in US and EU in Q2 EMA and FDA submissions expected Q3/Q4 2023 FDA submission expected Q4 2023 Primary endpoint met at interim analysis Ph3 Ph3 Ph3 Ph3 HS hidradenitis suppurativa. C3G PNH - paroxysmal nocturnal hemoglobinuria. complement 3 Glomerulopathy. mCRPC metastatic castration-resistant prostate cancer. IC-MPGN - immune complex membranoproliferative glomerulonephritis. 30 Investor Relations | Q2 2023 Results APPARENT study VICTORION-1P in Q1 1L (VAYHIT1) and 2L (VAYHIT2) FPFV in H1 SIRIUS-SLE 1 and 2 in Q1 FIR - first interpretable results. IgAN - immunoglobulin A nephropathy. U NOVARTIS | Reimagining Medicine#31Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Our pipeline projects at a glance Innovative medicines Solid Tumors Hematology Immunology Neuroscience Cardiovascular Others Ophthalmology Respiratory & Allergy IB&GH Biosimilars¹ Appendix Innovation: Clinical trials References Abbreviations Phase 1/2 Phase 3 Registration Total 78 44 7 129 14 12 2 28 18 7 1 26 20 10 4 34 6 5 0 11 15 82 553 0 13 0 17 1 0 4 3 0 0 3 9 1 0 10 n/a 2 0 2 Total 78 46 7 131 1. Selected disclosed, internal projects. Biosimilar pre-Phase 3 are not disclosed. 31 Investor Relations | Q2 2023 Results INNOVATION 1 NOVARTIS | Reimagining Medicine#32Company overview Innovation: Pipeline overview Financial review Financial performance Novartis pipeline in Phase 1 Solid tumors Code Name 177Lu-NeoB AAA603 AAA817 225 AC-PSMA-617 DFF332 DFF332 IAG933 IAG933 KFA115 KFA115 MGY825 MGY825 NZV930 NZV930 QEQ278 QEQ278 Immunology Code MHV370 Conclusions Mechanism Radioligand therapy target GRPR Radioligand therapy target PSMA HIF2A inhibitor Novel immunomodulatory Agent CD73 antagonist Indication(s) Multiple solid tumors Metastatic castration-resistant prostate cancer Renal cell carcinoma Mesothelioma Solid tumors NSCLC Solid tumors NKG2D/-L pathway modulator Solid tumors Name MHV370 Mechanism Indication(s) TLR7, TLR8 Antagonist Systemic lupus erythematosus Neuroscience Code NIO752 Name Mechanism NIO752 Tau antagonist Hematology Name Code DFV890 DFV890 HDM201 HDM201 (combos) MDM2 inhibitor JBH492 JBH492 MBG453 sabatolimab TIM3 antagonist MIK665 PIT565 VAY736 MIK665 MCL1 inhibitor PIT565 ianalumab + ibrutinib BAFF-R inhibitor Indication(s) Alzheimer's disease Progressive supranuclear palsy Mechanism NLRP3 inhibitor Indication(s) Low risk myelodysplastic syndrome Hematological malignancy Hematological malignancy Low risk myelodysplastic syndrome Hematological malignancies B-cell malignancies Hematological malignancy (combo) Diffuse large B-cell lymphoma Cancers Adult ALL VOB560 YTB323 VOB560 rapcabtagene autoleucel CD19 CAR-T 32 Investor Relations | Q2 2023 Results Appendix Innovation: Clinical trials Cardiovascular Code XXB750 References Abbreviations INNOVATION 17 lead indications Name XXB750 Mechanism NPR1 agonist Indication(s) Heart failure Others Code IB&GH EDI048 EYU688 Name EDI048 EYU688 INE963 INE963 Mechanism CpPI(4)K inhibitor NS4B inhibitor Indication(s) Cryptosporidiosis Dengue Malaria, uncomplicated Lead indication NOVARTIS | Reimagining Medicine#33Company overview Innovation: Pipeline overview Financial review Financial performance Novartis pipeline in Phase 2 Solid Tumors Code AAA601 Name Mechanism Lutathera® Indication(s) Conclusions Appendix Innovation: Clinical trials Hematology Radioligand therapy target SSTR GEPNET, pediatrics 1L ES-SCLC Glioblastoma NSCLC and CRC (mono and/or combo) MBG453 sabatolimab JDQ443 JDQ443 KRAS inhibitor NIS793 nisevokitug TGFB inhibitor 1L metastatic colorectal cancer TNO155 TNO155 SHP2 inhibitor Solid tumors Immunology Code Name CFZ533 iscalimab Mechanism CD40 inhibitor Indication(s) Sjögren's References Abbreviations INNOVATION 25 lead indications Lead indication Mechanism BCR-ABL inhibitor Code Name ABL001 Scemblix® INC424 Jakavi® JAK1/2 inhibitor TIM3 antagonist PHE885 PHE885 PKC412 Rydapte YTB323 rapcabtagene autoleucel Cardiovascular BCMA cell therapy Multi-targeted kinase inhibitor. CD19 CAR-T Indication(s) Chronic myeloid leukemia, 2L, pediatrics Acute GVHD, pediatrics Chronic GVHD, pediatrics Unfit acute myeloid leukemia Acute myeloid leukemia, maintenance 4L multiple myeloma Acute myeloid leukemia, pediatrics 1L high-risk large B-cell lymphoma Hidradenitis suppurativa Indication(s) CMK389 CMK389 IL-18 inhibitor Atopic dermatitis DFV890 DFV890 NLRP3 inhibitor Knee osteoarthritis Familial cold auto-inflammatory syndrome LNA043 LNA043 ANGPTL3 agonist Knee osteoarthritis Osteoarthritis (combos) LOU064 remibrutinib BTK inhibitor Food allergy Hidradenitis suppurativa Sjögren's LRX712 LRX712 MAS825 MAS825 Osteoarthritis Code Name CFZ533 LNP023 iscalimab TIN816 iptacopan TIN816 CFB inhibitor ATP modulator XXB750 XXB750 Mechanism CD40 inhibitor NPR1 agonist Indication(s) Lupus nephritis Lupus nephritis Acute kidney injury Hypertension Others Code IB&GH Name Mechanism NLRC4-GOF indications. KAE609 cipargamin MHV370 MHV370 TLR7, TLR8 Antagonist Sjögren's Mixed connective tissue disease KLU156 NG1226 NG1226 Tendinopathy Ganaplacide + lumefantrine QUC398 QUC398 ADAMTS5 inhibitor Osteoarthritis LXE408 LXE408 RHH646 RHH646 Osteoarthritis QMF149 AtecturaⓇ VAY736 ianalumab YTB323 BAFF-R inhibitor CD19 CAR-T Autoimmune hepatitis SEG101 Adakveo® srSLE/LN Respiratory rapcabtagene autoleucel Neuroscience Code Name BLZ945 sotuletinib DLX3131 minzasolmin MIJ821 onfasprodil Mechanism CSF-1R inhibitor Alpha-synuclein Inhibitor NR2B negative allosteric modulator 1. DLX313 is the Novartis compound code for UCB0599. Indication(s) Amyotrophic lateral sclerosis Parkinson's disease Treatment resistant depression Major depressive disorder with acute suicidal ideation or behavior CMK389 CMK389 LTP001 LTP001 Ophthalmology LNP023 PfATP4 inhibitor Non-artemisinin plasmodium falciparum inhibitor Proteasome inhibitor LABA + ICS P-selectin inhibitor IL-18 inhibitor SMURF1 inhibitor Malaria, severe Malaria, uncomplicated Malaria, uncomplicated Visceral leishmaniasis Asthma, pediatrics Sickle cell disease, pediatrics Pulmonary sarcoidosis Pulmonary arterial hypertension Idiopathic pulmonary fibrosis iptacopan CFB inhibitor PPY9882 PPY988 SAF3123 Libvatrep Gene therapy Complement factor I modulation TRPV1 antagonist ¡AMD Geographic atrophy Chronic ocular surface pain 2. Gyroscope acquisition. 3. 'Front of eye' ophthalmology divestment, subject to customary closing conditions; closing expected H2 2023. 33 Investor Relations | Q2 2023 Results U NOVARTIS | Reimagining Medicine#34Company overview Innovation: Pipeline overview Financial review Financial performance Novartis pipeline in Phase 3 Conclusions Appendix Innovation: Clinical trials References Abbreviations INNOVATION 6 lead indications Lead indication Solid Tumors Hematology Code Name Mechanism Indication(s) Code Name AAA617 PluvictoⓇ Radioligand therapy target PSMA Metastatic castration-resistant prostate cancer (mCRPC), pre-taxane Metastatic hormone sensitive prostate cancer (mHSPC) ABL001 ETB115 Scemblix® PromactaⓇ Mechanism BCR-ABL inhibitor AAA6011 LutatheraⓇ Radioligand therapy target SSTR Gastroenteropancreatic neuroendocrine tumors, 1st line in G2/3 tumors (GEP-NET 1L G3) BYL719 JDQ443 Piqray® JDQ443 PI3Ka inhibitor Ovarian cancer LNP023 MBG453 VAY736 iptacopan sabatolimab janalumab KRAS inhibitor 2/3L Non-small cell lung cancer LEE011 Kisqali® CDK4/6 Inhibitor VDT482 tislelizumab PD1 inhibitor HR+/HER2- BC (adj) 1L ESCC 1L Small cell lung cancer Localized ESCC Thrombopoietin receptor (TPO-R) agonist CFB inhibitor TIM3 antagonist BAFF-R inhibitor Indication(s) Chronic myeloid leukemia, 1st line Radiation sickness syndrome Atypical hemolytic uraemic syndrome Myelodysplastic syndrome 1L Immune Thrombocytopenia 2L Immune Thrombocytopenia warm Autoimmune Hemolytic Anemia Adj/Neo adj. NSCLC 1L Gastric cancer 1L Urothelial cell cancer Cardiovascular Immunology Code Name Code Name KJX839 Leqvio® AIN457 CosentyxⓇ Mechanism IL17A inhibitor Indication(s) Giant cell arteritis Mechanism siRNA (regulation of LDL-C) Indication(s) CVRR-LDLC Primary prevention Hyperlipidemia, pediatrics IGE025 LOU064 Xolair IgE inhibitor remibrutinib BTK inhibitor QGE031 ligelizumab IgE inhibitor VAY736 ianalumab Neuroscience Name Code AMG334 AimovigⓇ BAF312 Mayzent® LOU064 remibrutinib OAV101 AVXS-101 OMB157 Kesimpta® 1. 177 Lu-dotatate in US. Polymyalgia rheumatica Rotator cuff tendinopathy Food allergy Chronic spontaneous urticaria BAFF-R inhibitor Chronic spontaneous urticaria, pediatrics Food allergy Sjögren's Lupus Nephritis Systemic lupus erythematosus LNP023 iptacopan CFB inhibitor IgA nephropathy C3 glomerulopathy TQJ230 pelacarsen ASO targeting Lp(a) Others Name Mechanism C3 glomerulopathy, pediatrics IC-MPGN Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a) (CVRR-Lp(a)) Indication(s) PGH-1 (artemisinin combination Malaria, uncomplicated (<5kg patients) therapy) Mechanism CGRPR antagonist S1P1,5 receptor modulator BTK inhibitor Indication(s) Migraine, pediatrics Multiple sclerosis, pediatrics Multiple sclerosis SMN1 gene replacement therapy SMA IT administration Code IB&GH COA566 CoartemⓇ Ophthalmology RTH258 BeovuⓇ VEGF Inhibitor CD20 Antagonist 34 Investor Relations | Q2 2023 Results Multiple sclerosis, pediatrics Biosimilars Code GP2411 SOK583 Name denosumab aflibercept Diabetic retinopathy Mechanism anti RANKL mAb VEGF inhibitor Indication(s) Osteoporosis (same as originator) Ophthalmology indication (as originator) U NOVARTIS | Reimagining Medicine#35Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Novartis pipeline in registration Solid Tumors Code Name Mechanism Indication(s) VDT482 tislelizumab PD1 inhibitor 2L ESCC Non-small cell lung cancer Immunology Code Name Mechanism AIN457 Cosentyx® IL17A inhibitor IGE025 XolairⓇ IgE inhibitor 1. Approved in EU. Indication(s) Hidradenitis suppurativa¹ Psoriatic arthritis (IV formulation) Axial SpA (IV formulation) Auto-injector Appendix Innovation: Clinical trials Hematology Code LNP023 References Abbreviations INNOVATION 2 lead indications Name Mechanism Indication(s) iptacopan CFB inhibitor Paroxysmal nocturnal hemoglobinuria Lead indication 35 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#36Supplementary Lead Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Novartis submission schedule New Molecular Entities: Lead and supplementary indications 2023 iptacopan LNP023 PNH PluvictoⓇ AAA617 mCRPC, Pre-taxane tislelizumab VDT482 1L Gastric Cancer W tislelizumab VDT482 1L ESCC JDQ443 2024 JDQ443 2/3L NSCLC (mono) remibrutinib LOU064 CSU sabatolimab MBG453 HR-MDS Appendix Innovation: Clinical trials References Abbreviations INNOVATION Cardiovascular Immunology Neuroscience Solid tumors Hematology Non-core TA project 2025 pelacarsen TQJ230 CVRR-Lp(a) 177Lu-NeoB AAA603 Multiple Solid Tumors ianalumab VAY736 2L Immune Thrombocytopenia iscalimab CFZ533 Sjögren's syndrome ligelizumab QGE031 Food allergy LNA043 Knee osteoarthritis cipargamin KAE609 Malaria severe ganaplacide/lumefantrine KLU156 Malaria uncomplicated libvatrep² SAF312 COSP ≥2026 MIJ821 Depression Y rapcabtagene autoleucel YTB323 High-risk large B-cell lymphoma TNO155 Solid tumors XXB750 Hypertension LXE408 Visceral leishmaniasis PPY9881 Geographic atrophy iptacopan LNP023 C3G iptacopan LNP023 IgAN PluvictoⓇ AAA617 mHSPC tislelizumab VDT482 1L Small Cell Lung Cancer tislelizumab VDT482 Localized ESCC ianalumab VAY736 1L Immune Thrombocytopenia ianalumab VAY736 WAIHA ianalumab VAY736 АІН ianalumab VAY736 Sjögren's syndrome cipargamin KAE609 Malaria uncomplicated Y до ianalumab VAY736 Lupus Nephritis ianalumab VAY736 SLE iptacopan LNP023 aHUS iptacopan LNP023 IC-MPGN JDQ443 JDQ443 NSCLC (Combo) rapcabtagene autoleucel YTB323 Lupus Nephritis remibrutinib LOU064 Multiple sclerosis remibrutinib LOU064 Sjögren's syndrome sabatolimab MBG453 Unfit AML tislelizumab VDT482 Adj/Neo adj NSCLC tislelizumab VDT482 1L Urothelial cell cancer W 1. Gyroscope acquisition. 2. 'Front of eye' ophthalmology divestment, subject to customary closing conditions; closing expected H2 2023. 36 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#37Existing brands Company overview Innovation: Pipeline overview Financial review Financial performance Novartis submission schedule Supplementary indications for existing brands Conclusions Appendix Innovation: Clinical trials References Abbreviations INNOVATION Cardiovascular Immunology Neuroscience Solid tumors Hematology Non-core TA project KisqaliⓇ 2023 ribociclib, LEE011 HR+/HER2- BC (adj) XolairⓇ omalizumab, IGE025 Food allergy Piqray® alpelisib, BYL719 Ovarian cancer 2024 JakaviⓇ ruxolitinib, INC424 Pediatrics Acute GVHD JakaviⓇ ruxolitinib, INC424 Pediatrics Chronic GVHD LutatheraⓇ 177Lu-oxodotreotide1 GEP-NET 1L G3 ScemblixⓇ ABL001 CML 1L 2025 CosentyxⓇ secukinumab, AIN457 GCA Leqvio® KJX839 Ped Hyperlipidemia ZolgensmaⓇ AVXS-101 OAV101 SMA IT denosumab GP2411 anti RANKL mAb BioS Adakveo SEG101 Sickle cell disease, pediatrics aflibercept SOK583 BioS Neovascular age-related macular degeneration Coartem® artemether + lumefantrine, COA566 Malaria uncompl., formula for <5kg ty AimovigⓇ erenumab, AMG334 Pediatric Migraine Cosentyx® secukinumab, AIN457 Tendinopathy CosentyxⓇ secukinumab, AIN457 Polymyalgia rheumatica Y KesimptaⓇ2 ofatumumab Multiple sclerosis, pediatrics. LeqvioⓇ KJX839 CVRR-LDLC BeovuⓇ brolucizumab, RTH258. Diabetic retinopathy PromactaⓇ eltrombopag, ETB115 Radiation sickness syndrome AtecturaⓇ indacaterol + mometasone, QMF149 Asthma, pediatrics 1. 177 Lu-dotatate in US. 2. Kesimpta and Mayzent: Pediatric study in multiple sclerosis run in conjunction (NEOS). 37 Investor Relations | Q2 2023 Results ≥2026 ty Leqvio® KJX839 Primary prevention MayzentⓇ2 siponimod, BAF312 Multiple sclerosis, pediatrics ty RydaptⓇ midostaurin, PKC412 Acute myeloid leukemia, pediatrics ScemblixⓇ ABL001 CML, 2L, pediatrics O NOVARTIS | Reimagining Medicine#38Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials H1 growth driven by strong performance from EntrestoⓇ KesimptaⓇ, PluvictoⓇ and KisqaliⓇ H1 sales Entresto Sales USD million Growth vs. PY USD million 2,915 sacubitri/valsartan Kesimpta 873 (ofatumumab) PLUVICTO™ 451 KISQALI 908 361 ribociclib SCEMBLIX® 182 126 (asciminib) LEQVIO® 142 106 PROMACTA® 1,130 105 (eltrombopag) Tafinlar. Mekinist. 954 99 299 Adanie LUTATHERA 88 PIQRAY 246 (alpelisib) tablets 88 ILARIS (canakinumab) rolex 644 84 Growth vs. PY CC 697 35% 439 439 References Abbreviations GROWTH 103% nm Strong growth (+69% cc); 73% expected to continue 228% 293% 13% 15% 43% 57% 18% 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. nm not meaningful. 38 Investor Relations | Q2 2023 Results U NOVARTIS | Reimagining Medicine#39Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials FY 2023 guidance on other financial KPIs Barring unforeseen events; (in cc) Group | Full year guidance Core Net Expenses expected to decrease by around 0.1bn vs. 2022 Financial Result Core Tax Rate Expected to be broadly in line vs. 2022 Constant currencies (cc), core results are non-IFRS measures; explanation can be found on page 48 of Condensed Interim Financial Report. 39 Investor Relations | Q2 2023 Results References Abbreviations FINANCIAL PROFILE NOVARTIS | Reimagining Medicine#40Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials Expected currency impact for full year 2023 Currency impact vs. PY %pts, assuming mid-July exchange rates prevail in 2023 FX impact on Net sales References Abbreviations FX impact on Core operating income I FINANCIAL PROFILE 3 2 0 to -1 -1 -3 -2 to -3 -6 -5 -5 -8 -7 -8 I FY Q1 Q2 Q3 Q4 FY FY Q1 Q2 Q3 Q4 FY 2022 2023 2022 2023 Actual Simulation 40 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#41Company overview Innovation: Pipeline overview Financial review Financial performance Conclusions Appendix Innovation: Clinical trials References Abbreviations FINANCIAL PROFILE Net debt increased by USD 8.2bn mainly due to dividends and share buybacks, partly offset by FCF USD bn -7.2 -7.3 -5.7 Dec 31, 2022 Dividends Treasury share transactions, net 41 Investor Relations | Q2 2023 Results -8.2 -0.9 M&A/Intangible assets transactions, net -0.3 -15.4 6.0 Free Cash Flow Others June 30, 2023 NOVARTIS | Reimagining Medicine#42Company 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 42 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#43Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Conclusions Cardiovascular Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 43 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#44Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology iptacopan - CFB inhibitor Conclusions 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 Arms Intervention Arm 1 LNP023 200mg BID Arm 2 - Placebo BID Target Primary IgA Nephropathy patients Patients Readout Milestone(s) 2023 (primary endpoint for US initial submission, 9 months UPCR) 2025 (24 months) Publication Perkovic et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1: Study Design Arms Intervention 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 44 Investor Relations | Q2 2023 Results Readout Milestone(s) Publication 2026 TBD NOVARTIS | Reimagining Medicine#45Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology iptacopan - CFB inhibitor Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology iptacopan - CFB inhibitor References Abbreviations Other NCT03955445 (CLNP023B12001B) NCT04817618 APPEAR-C3G (CLNP023B12301) C3 glomerulopathy Phase 3 Indication C3 glomerulopathy (C3G) Indication Phase Phase 2 Phase Patients 27 patients from ongoing Ph2 (sample size from Ph3 pending HA discussions Q1 2021), total patients for this study will increase Patients 68 Primary Outcome Measures Arms Intervention Target Patients Characterize the effect of LNP023 treatment on a composite renal response endpoint at 9 months (1. a stable or improved eGFR and, 2. a reduction in proteinuria and 3. an increase in C3 compared to the CLNP023X2202 baseline visit) Open-label LNP023 200mg bid Patients with C3 glomerulopathy Primary Outcome Measures Log-transformed ratio to baseline in UPCR (sampled from a 24 hour urine collection) Experimental: iptacopan 200mg b.i.d. Placebo Comparator: Placebo to iptacopan 200mg b.i.d. Patients with native C3G Arms Intervention Target Patients Readout Milestone(s) 2023 Publication TBD Publication Wong et al 2021 Nephrology, Dialysis and Transplantation Vol. 36, Suppl. 1: eGFR trajectory Readout Milestone(s) 2025 45 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#46Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology LeqvioⓇ - siRNA (regulation of LDL-C) NCT03705234 ORION-4 (CKJX839B12301) Appendix Innovation: Clinical trials Neuroscience Oncology References Leqvio® - siRNA (regulation of LDL-C) NCT03814187 ORION-8 (CKJX839A12305B) Hyperlipidemia Indication Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH) Indication Phase Phase 3 Phase Phase 3 Patients Primary Outcome Measures 15000 A composite of major adverse cardiovascular events, defined as: Coronary heart disease (CHD) death; Patients 3275 Primary Outcome Measures Myocardial infarction; Arms Intervention Target Patients Fatal or non-fatal ischaemic stroke; or Urgent coronary revascularization procedure Arm 1: every 6 month treatment Inclisiran sodium 300mg (given by subcutaneous injection on the day of randomization, at 3 months and then every 6-months) for a planned median duration of about 5 years Arm 2: matching placebo (given bysubcutaneous injection on the day of randomization, at 3 months and then every 6 months) for a planned median duration of about 5 years. Patient population with mean baseline LDL-C ≥ 100mg/dL Arms Intervention Target Patients Readout Milestone(s) Publication Readout Milestone(s) 2026 Publication TBD 46 Investor Relations | Q2 2023 Results Abbreviations Other Proportion of subjects achieving prespecified low density lipoprotein cholesterol (LDL-C) targets at end of study Safety and tolerability profile of long-term use of inclisiran Inclisiran sodium 300mg on Day 90 and every 180 days for a planned duration of 3 years Patients with HeFH or pre-existing atherosclerotic cardiovascular disease (ASCVD) on background statin +/- ezetimibe therapy and risk equivalents (patients from ORION 3, 9, 10 & 11 studies) 2023 A pooled safety analysis of inclisiran in 3576 patients with approximately 10,000 person-years of exposure from seven trials; oral presentation; ACC 2-4 Mar 2023 NOVARTIS | Reimagining Medicine#47Company 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 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) 2025 Readout Milestone(s) (LDL-C) 2025 Publication Design publication (O-16/-13) in Eur. J. Prev. Cardiol. Vol. 29, Feb. 2022 (actual) Presentation at EAS May-2022 on O-13/-16 study design (actual) Readout Milestone(s) Publication 47 Investor Relations | Q2 2023 Results Design publication (O-16/-13) in Eur. J. Prev. Cardiol. Vol. 29, Feb. 2022 (actual) Presentation at EAS May-2022 on O-13/-16 study design (actual) NOVARTIS | Reimagining Medicine#48Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology LeqvioⓇ - siRNA (regulation of LDL-C) Conclusions 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 Phase 3 Patients 14000 Patients 16500 Primary Outcome Measures Target Patients Readout 2027 Milestone(s) Publication TBD Arms Intervention 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) 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 48 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#49Company 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 49 Investor Relations | Q2 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#50Company overview Financial review 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 Conclusions 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 50 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#51Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology Immunology Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 51 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#52Company 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 52 Investor Relations | Q2 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#53Company 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 53 Investor Relations | Q2 2023 Results Target Patients Readout Milestone(s) Publication 2025 TBD NOVARTIS | Reimagining Medicine#54Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology ianalumab - BAFF-R inhibitor NCT03217422 AMBER (CVAY736B2201) Indication Autoimmune hepatitis Phase 2 Conclusions Phase Patients 65 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 54 Investor Relations | Q2 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#55Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology ianalumab - BAFF-R inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology ianalumab - BAFF-R inhibitor Indication NCT05349214 NEPTUNUS-2 (CVAY736A2302) Sjögren's syndrome Indication NCT05350072 NEPTUNUS-1 (CVAY736A2301) Sjögren's syndrome Phase Phase 3 Phase Phase 3 Patients 489 Patients 285 Primary Outcome Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Measures Primary Outcome Measures Arms 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 55 Investor Relations | Q2 2023 Results References Abbreviations Other Intervention Target Patients Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Arm 1: Experimental - ianalumab Arm 2: Placebo comparator Patients with active Sjogren's syndrome Readout Milestone(s) Primary 2026 Publication TBD NOVARTIS | Reimagining Medicine#56Company 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 56 Investor Relations | Q2 2023 Results Readout Milestone(s) 2027 Publication TBD NOVARTIS | Reimagining Medicine#57Company 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 57 Investor Relations | Q2 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#58Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology LNA043-ANGPTL3 agonist Appendix Innovation: Clinical trials Neuroscience Oncology NCT04864392 ONWARDS (CLNA043A12202) Knee osteoarthritis Phase 2 Indication Phase Patients 550 Primary Outcome Measures Arms Intervention Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging LNA043 injection to the knee with dosing regimen A LNA043 injection to the knee with dosing regimen B LNA043 injection to the knee with dosing regimen C LNA043 injection to the knee with dosing regimen D Placebo injection to the knee Patients with Symptomatic knee osteoarthritis Target Patients Readout Milestone(s) Primary 2024 Publication TBD References Abbreviations Other 58 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#59Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology remibrutinib - BTK inhibitor Appendix Innovation: Clinical trials Neuroscience Oncology Indication Phase NCT05030311 REMIX-1 (CLOU064A2301) Chronic spontaneous urticaria Phase 3 Patients 450 Primary Outcome 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 59 Investor Relations | Q2 2023 Results remibrutinib - BTK inhibitor References Abbreviations Other NCT05032157 REMIX-2 (CLOU064A2302) Chronic spontaneous urticaria Phase 3 Indication Phase Patients 450 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#60Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 60 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#61Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience 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 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 61 Investor Relations | Q2 2023 Results Appendix Innovation: Clinical trials Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#62Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Appendix Innovation: Clinical trials Neuroscience Oncology MIJ821 - NR2B negative allosteric modulator (NAM) NCT04722666 (CMIJ821A12201) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Readout Milestone(s) Major depressive disorder with acute suicidal ideation or behavior Phase 2 195 Change from baseline to 24 hours in the total score of the Montgomery Åsberg Depression Rating Scale (MADRS) MIJ821 (mg/kg) very low dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29 MIJ821 (mg/kg) low dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29 MIJ821 (mg/kg) high dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29 MIJ821 (mg/kg) very high dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29 Placebo 40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29 MIJ821 (mg/kg) high dose for 40 minutes IV infusion on Day 1 followed by Placebo 40 minutes IV infusion of 0.9% sodium chloride on Day 15 and Day 29 MIJ821 (mg/kg) very high dose for 40 minutes IV infusion on Day 1 followed by Placebo 40 minutes IV infusion of 0.9% sodium chloride on Day 15 and Day 29 Participants who have suicidal ideation with intent 2023 (interim) Publication TBD 62 Investor Relations | Q2 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#63Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology remibrutinib - BTK inhibitor 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 63 Investor Relations | Q2 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#64Company 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 64 Investor Relations | Q2 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#65Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Oncology Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other 65 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#66Company 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 66 Investor Relations | Q2 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#67Company 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 67 Investor Relations | Q2 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#68Company 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 68 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#69Company overview Financial review Conclusions 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 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 69 Investor Relations | Q2 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#70Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology JDQ443 - KRAS inhibitor NCT05132075 KontRASt-02 (CJDQ443B12301) Indication Non-small cell lung cancer, 2/3L Phase Phase 3 Patients 360 Primary Progression free survival (PFS) Outcome Conclusions 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 70 Investor Relations | Q2 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#71Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology KisqaliⓇ - CDK4 inhibitor Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology NCT03701334 NATALEE (CLEE011012301C) Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Adjuvant treatment of hormone receptor (HR)-positive, HER2-negative, early breast cancer (EBC) Phase 3 5101 Invasive Disease-Free Survival for using STEEP criteria (Standardized Definitions for Efficacy End Points in adjuvant breast cancer trials) Ribociclib endocrine therapy Endocrine therapy Pre and postmenopausal women and men with HR-positive, HER2-negative EBC, after adequate surgical resection, who are eligible for adjuvant endocrine therapy 2023 (actual) Readout Milestone(s) Publication TBD 71 Investor Relations | Q2 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#72Company overview Financial review Innovation: Pipeline overview Financial performance Cardiovascular Immunology Piqray® - PI3K-alpha inhibitor NCT04729387 EPIK-O (CBYL719K12301) Indication Ovarian Cancer Phase 3 Conclusions Appendix Innovation: Clinical trials Neuroscience Oncology Phase Patients 358 Primary Outcome Measures Arms Intervention Progression Free Survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment using RECIST 1.1 criteria Arm 1 Experimental: Alpelisib+olaparib: Alpelisib 200 mg orally once daily and olaparib 200 mg orally twice daily on a continuous dosing schedule Arm 2 Active Comparator: Paclitaxel or PLD. Investigator's choice of one of 2 single agent cytotoxic chemotherapies: Paclitaxel 80 mg/m2 intravenously weekly or Pegylated liposomal Doxorubicin (PLD) 40-50 mg/m2 (physician discretion) intravenously every 28 days. Patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected Target Patients Readout Milestone(s) 2023 Publication TBD 72 Investor Relations | Q2 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#73Company overview Innovation: Pipeline overview Cardiovascular Financial review Conclusions Financial performance Immunology 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 73 Investor Relations | Q2 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#74Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology Neuroscience RydaptⓇ - Multi-targeted kinase inhibitor NCT03591510 (CPKC412A2218) Indication Acute myeloid leukemia, pediatrics Phase 2 Phase Patients 20 Primary Outcome Measures Arms Intervention Target Patients Occurrence of dose limiting toxicities Safety and Tolerability Chemotherapy followed by Midostaurin Newly diagnosed pediatric patients with FLT3 mutated acute myeloid leukemia (AML) Readout 2026 Milestone(s) Publication TBD Appendix Innovation: Clinical trials Oncology References Abbreviations Other 74 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#75Company 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 75 Investor Relations | Q2 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#76Company overview Financial review 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 Conclusions 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 76 Investor Relations | Q2 2023 Results Appendix Innovation: Clinical trials Neuroscience Oncology References Abbreviations Other NOVARTIS | Reimagining Medicine#77Company 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 77 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#78Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology Ophthalmology Other Conclusions Neuroscience Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 78 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#79Company overview Innovation: Pipeline overview Cardiovascular Financial review Financial performance Immunology Ophthalmology Conclusions Ophthalmology Neuroscience Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 79 Investor Relations | Q2 2023 Results 1 NOVARTIS | Reimagining Medicine#80Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology 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 Neuroscience Oncology References Abbreviations Other 80 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#81Company overview Financial review Conclusions Innovation: Pipeline overview Financial performance Cardiovascular Immunology 81 libvatrep - TRPV1 antagonist Indication Phase NCT04630158 SAHARA (CSAF312B12201) Chronic ocular surface pain Phase 2 Patients 150 Primary Change in mean pain severity Visual Analog Scale Outcome Measures Arms Intervention Appendix Innovation: Clinical trials Neuroscience Oncology Target Patients Placebo Comparator: SAF312 Placebo. Randomized to a 1:1:1 topical eye drops, twice daily Experimental: SAF312 dose 1. Randomized to a 1:1:1 topical eye drops, twice daily Experimental: SAF312 dose 2. Randomized to a 1:1:1 topical eye drops, twice daily Subjects with CICP persisting at least for 4 months after refractive surgery and chronicity confirmed during the observational period. Readout Milestone(s) 2023 Publication 2023 Investor Relations | Q2 2023 Results References Abbreviations Other NOVARTIS | Reimagining Medicine#82Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology Global Health Conclusions Neuroscience Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 82 Investor Relations | Q2 2023 Results 1 NOVARTIS | Reimagining Medicine#83Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology Adakveo® - P-selectin inhibitor NCT03474965 SOLACE-Kids (CSEG101B2201) Indication Sickle cell disease, pediatrics Phase 2 PK/PD and safety of SEG101 at 5 mg/kg Phase Patients 100 Primary Outcome Measures Arms Conclusions Neuroscience Global Health Intervention Target Patients Readout Milestone(s) Publication SEG101 (crizanlizumab) at a dose of 5 mg/kg by IV infusion + Hydroxyurea/Hydroxycarbamide Pediatric SCD patients with VOC H2-2021 (pediatric patients ≥12 year old) 2024 (pediatric patients <12 year old) 1. Matthew M. Heeney, David C. Rees, Mariane de Montalembert, Isaac Odame, R. Clark Brown, Yasser Wali, Thu Thuy Nguyen, Du Lam, Raquel Merino Herranz, Julie Kanter; Study Design and Initial Baseline Characteristics in Solace- Kids: Crizanlizumab in Pediatric Patients with Sickle Cell Disease. Blood 2020; 136 (Supplement 1): 22-24. doi: https://doi.org/10.1182/blood-2020-137081 2. Matthew M. Heeney, David C. Rees, Mariane De Montalembert, Isaac Odame, R. Clark Clark Brown, Yasser Wali, Thu Thuy Nguyen, Du Lam, Nadege Pfender, Julie Kanter; Initial Safety and Efficacy Results from the Phase II, Multicenter, Open-Label Solace-Kids Trial of Crizanlizumab in Adolescents with Sickle Cell Disease (SCD). Blood 2021; 138 (Supplement 1): 12. doi: https://doi.org/10.1182/blood-2021-144730 83 Investor Relations | Q2 2023 Results Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 1 NOVARTIS | Reimagining Medicine#84Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology cipargamin - PfATP4 inhibitor NCT04675931 KARISMA (CKAE609B12201) Indication Malaria severe Phase 2 Conclusions 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) 2024 Publication TBD Neuroscience Global Health Appendix Innovation: Clinical trials References Abbreviations Oncology Other Biosimilars 84 Investor Relations | Q2 2023 Results 1 NOVARTIS | Reimagining Medicine#85Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology Conclusions Neuroscience Global Health CoartemⓇ - PGH-1 (artemisinin combination therapy) NCT04300309 CALINA (CCOA566B2307) Malaria, uncomplicated (<5kg patients) Phase 3 Indication Phase Patients 44 Primary 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 Primary outcome measure: 2023 Readout Milestone(s) Publication TBD Appendix Innovation: Clinical trials References Abbreviations Oncology Other Biosimilars 85 Investor Relations | Q2 2023 Results 1 NOVARTIS | Reimagining Medicine#86Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology ganaplacide - Non-artemisinin plasmodium falciparum inhibitor NCT04546633 KALUMI (CKAF156A2203) Malaria, uncomplicated Phase 2 Conclusions Indication 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 2023 TBD Neuroscience Global Health Appendix Innovation: Clinical trials References Abbreviations Oncology Other Biosimilars 86 Investor Relations | Q2 2023 Results 1 NOVARTIS | Reimagining Medicine#87Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology Biosimilars Conclusions Neuroscience Global Health Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 87 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#88Company overview Innovation: Pipeline overview Financial review Financial performance Cardiovascular Immunology Ophthalmology aflibercept - VEGF inhibitor NCT04864834 Mylight (CSOK583A12301) Ophthalmology indication (as originator) Phase 3 Indication Phase Patients 460 Primary Outcome Conclusions Neuroscience Global Health Measures Arms Intervention Best-corrected visual acuity (BCVA) will be assessed using the ETDRS testing charts at an initial distance of 4 meters. The change from baseline in BCVA in letters is defined as difference between BCVA score between week 8 and baseline Arm 1 Biological: SOK583A1 (40 mg/mL) Arm 2 Biological: Eylea EU (40 mg/mL) Patients with neovascular age-related macular degeneration Target Patients Readout 2023 Milestone(s) Publication tbd Appendix References Innovation: Clinical trials Abbreviations Oncology Other Biosimilars 88 Investor Relations | Q2 2023 Results NOVARTIS | Reimagining Medicine#89Company 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 89 Investor Relations | Q2 2023 Results U NOVARTIS | Reimagining Medicine#90Company 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. AHA/ACC/HFSA/ESC 3 4 Pediatric indication would support extension of the regulatory data protection to November 2026 in EU 5 Primary endpoint: NT-proBNP in HFPEF. Mentz RJ, Ward JH, Hernandez AF, et al. Angiotensin-neprilysin inhibition in patients with mildly reduced or preserved ejection fraction and worsening heart failure KesimptaⓇ 1 Rolling 4 weeks. 1 June 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 4 The initial dosing period consists of 20 mg subcutaneous doses at Weeks 0, 1 and 2, thereafter once a month. Patient must take pen out of the refrigerator 15-30 minutes before self-administering. 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. 90 Investor Relations | Q2 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