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Novartis (NVS) · 39 slides · Filed Oct 21, 2026
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Slide 1 — Novartis ASCO Event
Novartis ASCO Event Investor Presentation June 4, 2023 Novartis Investor Relations
Slide 2 — Disclaimer
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,” “will,” “planned,” “pipeline,” “outlook,” or similar expressions, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Kisqali or any other investigational or approved products described in this presentation, or regarding potential future revenues from Kisqali or any other investigational or approved products described in this presentation. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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. There can be no guarantee that Kisqali or any other 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 Kisqali or any other investigational or approved products described in this presentation will be commercially successful in the future. In particular, our expectations regarding Kisqali or any other investigational or approved products described in this presentation could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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 contained in this presentation as a result of new information, future events or otherwise. All product names appearing in italics are trademarks owned by or licensed to Novartis Group companies. NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 2
Slide 3 — Participants
Participants Shreeram Aradhye, MD President, Global Drug Development & Chief Medical Officer Jeff Legos, PhD EVP, Global Head of Oncology & Hematology Development Reshema Kemps-Polanco EVP and US Head, Novartis Oncology NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 3
Slide 4 — Agenda
Agenda 4 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 1 Novartis at ASCO 2023 2 Kisqali NATALEE trial in early breast cancer 3 Kisqali: Establishing the CDK4/6 of choice 4 Q&A
Slide 5 — Novartis oncology pipeline focused in areas of high unmet need
Solid Tumors Hematology Disease areas (Selected) Breast Cancer Prostate Cancer Lung Cancer Non-Hodgkin’s Lymphoma Myeloid Cancers Non-Malignant Hematology Commercial assets Pipeline assets and opportunities Novartis oncology pipeline focused in areas of high unmet need where we have deep expertise AML / MDS – Acute Myeloid Leukemia / Myelodysplastic Syndrome. HR+/HER2− – hormone receptor-positive / human epidermal growth factor receptor 2-negative. NSCLC – non-small cell lung cancer. mPDAC – metastatic pancreatic ductal adenocarcinoma. mCRC – metastatic colorectal cancer. PNH – paroxysmal nocturnal hemoglobinuria. aHUS – atypical hemolytic uremic syndrome. 5 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Leveraging advanced therapy platforms such as radioligand therapy, cell therapy, and differentiated biologics Kisqali Adjuvant HR+/HER2- BC JDQ433 NSCLC Pluvicto Prostate cancer NIS793 1L mPDAC / 1L mCRC Iptacopan PNH, aHUS YTB323 Non-Hodgkin's Lymphoma Ianalumab Multiple indications PHE885 Multiple Myeloma
Slide 6 — Key assets in solid tumors and hematology highlighted at ASCO
Key assets in solid tumors and hematology highlighted at ASCO 6 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 63 abstracts Data highlights 5 oral presentations 3 poster discussions 36 posters 19 abstracts (publication only) Kisqali NATALEE Ph3 study in early breast cancer New analyses from Pluvicto VISION trial in prostate cancer JDQ443 KontRASt-01 trial in KRAS G12C-mutated lung cancer PHE885 updated Ph1 data in r/r Multiple Myeloma
Slide 7 — Kisqali’s mechanism of action is unique in inhibiting CDK4
Kisqali’s mechanism of action is unique in inhibiting CDK4 eight times more than CDK61-4 1. Yu Q, Sicinska E, Geng Y, et al. Requirement for CDK4 kinase function in breast cancer. Cancer Cell. 2006;9(1):23-32. 2. An H-X, Beckmann MW, Reifenberger G, Bender HG, Niederacher D. Gene amplification and overexpression of CDK4 in sporadic breast carcinomas is associated with high tumor cell proliferation. Am JPathol. 1999;154(1):113-118. 3. Kim S, Tiedt R, Loo A, et al. The potent and selective cyclin-dependent kinases 4 and 6 inhibitor ribociclib (LEE011) is a versatile combination partner in preclinical cancer models. Oncotarget. 2018;9(81):35226-35240;(suppl). 4. Sammons SL, Topping DL, Blackwell KL. HR+, HER2-advanced breast cancer and CDK4/6 inhibitors: mode of action, clinical activity, and safety profiles. Curr Cancer Drug Targets. 2017;17(7):637-649. 7 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Select differences among CDK4/6 inhibitors1-4 At clinically relevant doses, ribociclib provides greater CDK4 inhibition in vivo than competitors Higher unbound Cavg means more drug available to act on tumor cells1-4 More time for on-target CDK4 inhibition enables irreversible cell growth arrest (senescence) of micro-metastases and immuno-modulation CDK4:CDK6 inhibition from a cellular assay Unbound Cavg relative to palbociclib 22x 1x 8x 19x 16x 13x 10x 4x 1x 2x 3x 4x 5x 6x 7x 7x Palbociclib Abemaciclib Ribociclib
Slide 8 — NATALEE study builds on a strong foundation in metastatic
Median OS NATALEE study builds on a strong foundation in metastatic breast cancer (mBC), where Kisqali has a proven OS benefit 1. In months vs. vs 51.4, P value: 0.008. Reference: Hortobagyi, GN et al., 2022. 2. vs 48.0. Reference: Lu, YS et al., 2022. 3. vs 51.8. Reference: Neven, P et al., 2022. 4. Based on an analysis of MONALEESA-2, -3 and -7. OS – overall survival. 1L – first line. AI – aromatase inhibitor. Kisqali Ph3 OS results in 1L mBC Proven OS benefit across all three Phase 3 trials: regardless of menopausal status, hormone therapy partner, or dose modifications4 MONALEESA-2 MONALEESA-7 MONALEESA-3 24% risk reduction 24% risk reduction 33% risk reduction months1 63.9 months2 58.7 months3 67.6 Kisqali is the only CDK4/6i with statistically significant OS benefit proven across all three Ph3 trials, while maintaining or improving QoL Kisqali set a new benchmark for survival, with unprecedented median OS of ~5 years when combined with letrozole or fulvestrant in 1L mBC NCCN guidelines recommend Kisqali as the only Category 1 treatment for 1L mBC in combination with AI (~60% of 1L mBC patients) NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 8
Slide 9 — Early Breast Cancer (eBC) remains an area of high unmet need
HR+/HER2- ~75% HER2+ ~15% TNBC ~10% 50% 36% 171k 14% 64k Stage I Stage II+III Stage IV Early Breast Cancer (eBC) remains an area of high unmet need 9 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Total breast cancer patient population Annual incidence, US+EU5 ~620k Data Source: Kantar Health – US/ EU5 Patient Metrics 2023 1. Pan H, et al. N Engl J Med. 2017;377:1836-1846. 2. Gomis RR, et al. Mol Oncol. 2017; 11:62-78. 3. Cerner Enviza CancerMpact surveyed data as of Sep’22. Risk of recurrence Stage II and III eBC patients are at significant risk of recurrence1: Between a third and a half will see their cancer recur in their lifetime1 Half of recurrences occur beyond 5 years2 Quality of life (QoL) Improving patient outcomes without putting additional burden on the patient is essential3 The treatment goal in eBC is to prevent disease recurrence while maintaining QoL
Slide 10 — Agenda
Agenda 10 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 1 Novartis at ASCO 2023 2 Kisqali NATALEE trial in early breast cancer 3 Kisqali: Establishing the CDK4/6 of choice 4 Q&A
Slide 11 — NATALEE study design
Anatomic stage IIA1 N0 with: - Grade 2 and evidence of high risk: Ki-67 ≥ 20%; Oncotype DX Breast Recurrence Score ≥ 26; or high risk vs. genomic risk profiling - Grade 3 N1 Anatomic stage IIB1 & III Stage IIB: N0 or N1 Stage III: N0, N1, N2 or N3 N=51012 NATALEE study design 1. Enrollment of patients with stage II disease was capped at 40%. 2. 5101 patients were randomized from 10 Jan 2019 to 20 April 2021. 3. Open-label design. 4. Per investigator choice. 5. In pre-menopausal women and in men. ET – endocrine therapy. CT – chemotherapy. ctDNA/RNA – circulating tumor DNA/RNA. eBC – early breast cancer. iDFS – invasive disease-free survival. NSAI – nonsteroidal aromatase inhibitor. PAM50 – prediction analysis of microarray 50. PK – pharmacokinetics. PRO – patient reported outcome. R – randomized. STEEP – Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials. 11 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION NATALEE: Adult patients with HR+/HER2- eBC | Prior ET allowed up to 12 months Primary endpoint: iDFS using STEEP criteria Secondary endpoints: Recurrence-free survival Distant disease-free survival OS PROs Safety and tolerability PK Exploratory endpoints: Loco-regional recurrence-free survival Gene expression and alterations in tumor ctDNA/ctRNA samples 3 weeks on/1 week off Kisqali 400mg QD NSAI Letrozole or anastrozole4 +goserelin5 NSAI Letrozole or anastrozole4 +goserelin5 ≥ 5y ≥ 5y R 1:13 36 mths Randomization stratification: Anatomic stage II vs. III Menopausal status Premenopausal women & men vs. postmenopausal women Receipt of prior (neo)adjuvant chemotherapy: Yes/No Geographic location: North America/Western Europe/ Oceania vs. Rest of World
Slide 12 — NATALEE was uniquely designed to leverage Kisqali’s strengths and
NATALEE was uniquely designed to leverage Kisqali’s strengths and address significant unmet needs in eBC N – node. N0 – no nodal involvement. 12 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Insights NATALEE trial design Population Stage II and III patients are at significant risk of recurrence Broad population of stage II and III eBC patients, including those with N0 disease Dose Tumor control achievable with lower drug concentration vs. mBC, given lower tumor burden Lower dose (400mg) to improve tolerability and adherence while maintaining efficacy Treatment period Longer on-target CDK4 inhibition may be critical to induce senescence to prevent both early and late recurrences 3-year treatment duration to address risk of recurrence
Slide 13 — NATALEE included a broad population of stage II and III patients at
NATALEE included a broad population of stage II and III patients at risk of recurrence, including those with no nodal involvement 1. Amin MB, et al, eds. AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer; 2017:587-636. 2. Slamon DJ, et al. J Clin Oncol. 2019;37(suppl 15). Abstract TPS597. 3. Data on file. NATALEE CLEE011O12301C (TRIO033). Clinical study protocol. V4.0. Novartis Pharmaceuticals Corp; August 27, 2020. 13 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Patients at risk of recurrence, regardless of nodal status AJCC Anatomical Staging1 TN (M0) NATALEE2,3 Stage IA T1N0 X Stage IB T0N1mi X T1N1mi X Stage IIA T0N1 ✓ T1N1 ✓ T2N0 If G3; or G2 with Ki-67 ≥ 20%; or high genomic risk Stage IIB T2N1 ✓ T3N0 ✓ Stage IIIA T0N2 ✓ T1N2 ✓ T2N2 ✓ T3N1 ✓ T3N2 ✓ Stage IIIB T4N0 ✓ T4N1 ✓ T4N2 ✓ Stage IIIC Any TN3 ✓
Slide 14 — Baseline characteristics were balanced between treatment arms
Baseline characteristics were balanced between treatment arms 1. In the RIB+NSAI arm there were 11 men (0.4%) and in the NSAI alone arm there were 9 men (0.4%). 2. A total of 14 patients with Stage I disease were included: 9 pts (0.4%) in the RIB + NSAI arm and 5 pts (0.2%) in the NSAI alone arm. 3. Stage is derived using TNM from surgery for patients having not received (neo)adjuvant treatment, or as worst stage derived using TNM at diagnosis and TNM from surgery for patients having received (neo)adjuvant treatment. 4. Prior OFS was received by 670 pts (26.3%) in the RIB + NSAI arm and 620 pts (24.3%) in the NSAI alone arm. RIB – ribociclib. CT – chemotherapy. N0 – no nodal involvement. N1 – 1-3 axillary lymph nodes. N2 – 4-9 axillary lymph nodes. N3 – 10 or more axillary lymph nodes or collarbone lymph nodes. NX – regional nodes were not assessed. 14 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Parameter RIB + NSAI n = 2549 NSAI alone n = 2552 All patients N = 5101 Age, median (min-max), years 52 (24-90) 52 (24-89) 52 (24-90) Menopausal status, n (%) Premenopausal women and men1 Postmenopausal women 1126 (44) 1423 (56) 1132 (44) 1420 (56) 2258 (44) 2843 (56) Anatomic stage2,3, n (%) Stage IIA Stage IIB Stage III 479 (19) 532 (21) 1528 (60) 521 (20) 513 (20) 1512 (59) 1000 (20) 1045 (20) 3040 (60) Nodal status at diagnosis, n (%) NX N0 N1 N2/N3 272 (11) 694 (27) 1050 (41) 483 (19) 264 (10) 737 (29) 1049 (41) 467 (18) 536 (11) 1431 (28) 2099 (41) 950 (19) Prior ET, n (%)4 Yes 1824 (72) 1801 (71) 3625 (71) Prior (neo)adjuvant CT, n (%) Yes 2249 (88) 2245 (88) 4494 (88) ECOG PS, n (%) 0 1 2106 (83) 440 (17) 2132 (84) 418 (16) 4238 (83) 858 (17)
Slide 15 — At the interim analysis, median follow-up for iDFS was 27.7 months;
At the interim analysis, median follow-up for iDFS was 27.7 months; 20% patients in the Kisqali arm had completed 3 years of treatment 1. Overall study median follow-up 34.0 months (minimum, 21 months); median follow-up for iDFS 27.7 months. 2. Includes patients who are still ongoing on treatment. IA – interim analysis. ITT population Received study treatment N = 2549 n = 2526 N = 2552 n = 2442 Kisqali + NSAI NSAI Alone NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 15 Median follow-up for iDFS at the IA: 27.7 months1 57% of patients in Kisqali arm had completed 2 years of treatment2 20% of patients in Kisqali arm had completed 3 years of treatment
Slide 16 — Kisqali showed a clinically meaningful and statistically significant
Kisqali showed a clinically meaningful and statistically significant improvement in iDFS, reducing the risk of recurrence by 25% 1. One-sided P value. iDFS – invasive disease-free survival. 16 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION RIB + NSAI NSAI alone 3-year iDFS rate 90.4% 87.1% HR (95%, CI) 0.75 (0.62-0.91) P value1 0.0014 No. at risk NSAI alone RIB+NSAI 0 25 50 75 100 0 6 12 18 24 30 36 42 48 Time 2552 2240 2166 2071 1631 1067 286 13 0 2549 2350 2274 2193 1718 1111 311 12 0 Invasive Disease-Free Survival (%)
Slide 17 — iDFS benefit was consistent across subgroups, including stage II
HR (95% CI) Menopausal status Pre-menopausal women and men 0.72 (0.53, 0.98) Post-menopausal women 0.78 (0.61, 0.997) AJCC stage Stage II 0.76 (0.53, 1.10) Stage Ill 0.74 (0.59, 0.92) Prior CT Neoadjuvant 0.78 (0.61, 1.01) Adjuvant 0.67 (0.49, 0.93) Prior ET Yes 0.76 (0.60, 0.96) No 0.77 (0.56, 1.08) Region North America/Western Europe/Oceania 0.76 (0.59, 0.97) Rest of world 0.76 (0.56, 1.02) Histological grade at time of surgery Grade 1 0.78 (0.33, 1.85) Grade 2 0.75 (0.58, 0.97) Grade 3 0.78 (0.55, 1.08) Ki-67 status1 Ki-67 ≤20 0.80 (0.59, 1.08) Ki-67 >20 0.75 (0.56, 0.996) Nodal status2,3 N0 0.63 (0.34, 1.16) N1-N3 0.77 (0.63, 0.94) iDFS benefit was consistent across subgroups, including stage II and stage III, and node-negative and node-positive patients 1. From archival tumor tissue. 2. Nodal status classification according to AJCC staging. 3. Nodal status is from the worse stage derived per surgical specimen or at diagnosis. AJCC – American Joint Committee on Cancer. 17 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION
Slide 18 — Kisqali demonstrated a consistent benefit in distant disease-free
Kisqali demonstrated a consistent benefit in distant disease-free survival, with a 26% risk reduction... Distant disease-free survival (DDFS) defined as the time from date of randomization to date of first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer. 18 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 2549 2352 2280 2199 1729 1119 12 0 311 No. at risk Time 2552 2244 2168 2080 1643 1076 13 0 288 0 25 50 100 0 6 12 18 24 30 75 Distant Disease-Free Survival (%) 42 48 36 NSAI alone RIB+NSAI RIB + NSAI NSAI alone 3-year DDFS rate 90.8% 88.6% HR (95%, CI) 0.74 (0.60-0.91) P value 0.0017
Slide 19 — ... and a 28% risk reduction with respect to recurrence-free survival
... and a 28% risk reduction with respect to recurrence-free survival 19 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 2549 2358 2283 2210 1733 1124 12 0 314 RIB+NSAI No. at risk 0 25 50 75 100 0 6 12 18 24 30 Recurrence-Free Survival, % Time 42 48 36 2552 2247 2174 2086 1646 1080 13 0 290 NSAI alone RIB + NSAI NSAI alone HR (95%, CI) 0.72 (0.58-0.88) P value 0.0008
Slide 20 — Kisqali showed a trend for improved overall survival, reducing the
Kisqali showed a trend for improved overall survival, reducing the risk of death by 24% ITT – intent to treat 20 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION RIB + NSAI NSAI alone n/N (%) 61/2549 (2.4) 73/2552 (2.9) HR (95%, CI) 0.76 (0.54-1.07) P value 0.0563 While OS data remain immature in the ITT population, Kisqali + NSAI showed a trend for improved overall survival, reducing the risk of death by 24% compared to NSAI alone Additional follow-up for OS is planned
Slide 21 — Kisqali at the 400mg dose was safe and well tolerated, with low
Kisqali at the 400mg dose was safe and well tolerated, with low rates of symptomatic AEs... 1. This is a grouped term that combines neutropenia and neutrophil count decreased. 2. This is a grouped term that includes all preferred terms identified by Standardized MedDRA Queries for drug-related hepatic disorders and included ALT and AST increased, γ-glutamyltransferase increased, blood alkaline phosphatase increased, and blood bilirubin increased. 3. This is a grouped term that includes all preferred terms identified by Standardized MedDRA Queries for interstitial lung disease. AE – adverse event. ALT – alanine aminotransferase. AST – aspartate aminotransferase. ILD – interstitial lung disease. 21 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION RIB + NSAI n = 2524 NSAI Alone n = 2444 Any Grade Grade ≥ 3 Any Grade Grade ≥ 3 AESIs, % Neutropenia1 Febrile neutropenia 62.1 0.3 43.8 0.3 4.5 0 0.8 0 Liver-related AEs2 25.4 8.3 10.6 1.5 QT interval prolongation ECG QT prolonged 5.2 4.2 1.0 0.2 1.2 0.7 0.5 0 ILD pneumonitis3 1.5 0 0.8 0.1 Other clinically relevant AEs,% Arthralgia 36.5 1.0 42.5 1.3 Nausea 23.0 0.2 7.5 <0.1 Headache 22.0 0.4 16.5 0.2 Fatigue 21.9 0.7 12.7 0.2 Diarrhea 14.2 0.6 5.4 0.1 VTE 1.4 0.6 0.6 0.2
Slide 22 — ... which contributed to limited treatment modifications when
... which contributed to limited treatment modifications when administered up to three years 22 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Overall incidence, types and severity of AEs, as well as discontinuation rates due to AEs, were predictable and manageable, with no new safety signals identified with longer follow-up 19% of patients discontinued due to AEs, about half protocol-mandated due to asymptomatic liver-related AEs, e.g. ALT/AST increases (in which case patients can continue ET) Most discontinuations occurred early in treatment; median time to onset within first 4 months Symptomatic AEs were low and not key drivers of dose reductions or discontinuations Only 22% of patients on Kisqali reduced the dose
Slide 23 — NATALEE results support Kisqali + ET as treatment of choice in a
NATALEE results support Kisqali + ET as treatment of choice in a broad population of stage II and III patients at risk of recurrence 23 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Kisqali demonstrated robust efficacy... Statistically significant improvement in iDFS Consistent benefit across subgroups Trend for improved overall survival RFS and DDFS consistent with primary endpoints ... with a favorable safety profile No new safety signals 400mg dose well tolerated, with limited need for dose reductions Symptomatic AEs were low and not key drivers of discontinuation 1 2 Global regulatory filings including US and EU expected in H2 2023
Slide 24 — Agenda
Agenda 24 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 1 Novartis at ASCO 2023 2 Kisqali NATALEE trial in early breast cancer 3 Kisqali: Establishing the CDK4/6 of choice 4 Q&A
Slide 25 — Of all CDK4/6 inhibitors, Kisqali has the potential to address the
Of all CDK4/6 inhibitors, Kisqali has the potential to address the unmet needs of the broadest range of HR+/HER2- BC patients Data Source: Kantar Health – US/ EU5 Patient Metrics 2023 1. Cerner Enviza CancerMpact surveyed data as of Sep’22. 25 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Total breast cancer patient population Annual incidence, US+EU5 ~620k Metastatic Breast Cancer (mBC) Kisqali is the only CDK4/6 inhibitor with proven OS benefit across 3 Ph3 trials Consistent OS benefit regardless of combination partner, line of therapy, menopausal status, or site and number of metastases Incident population: 32k US, 32k EU5 Treatment rate (CDK4/6i): 50-60%1 Early Breast Cancer (eBC) Kisqali demonstrated efficacy in the at-risk stage II and III patient population, regardless of nodal involvement Consistent benefit across subgroups Incident population (stage II and III): 81k US, 90k EU5 Treatment rate (ET; stage II and III): 70-80%1 HR+/HER2- ~75% HER2+ ~15% TNBC ~10% 50% 36% 171k 14% 64k Stage I Stage II+III Stage IV
Slide 26 — NATALEE would significantly expand our reach, compared to
NATALEE would significantly expand our reach, compared to metastatic and compared to competition 1. Data on file, Novartis. 2. Estimated incidence data sources: DRG (US) and Kantar (EU5). TNM and grade information based on SEER AJCC 8th Incidence Report. 3. Under stage II: N0, T0N1 is excluded; T2N0 only if G3, or G2 with Ki67≥20% or high risk on Oncotype DX / Prosigna / MammaPrint / EndoPredict. 4. Unprobabilized peak sales. 26 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION NATALEE covers broad population in HR+/HER2- eBC Stage III (39k)2 Stage II (132k)2 N0 N0 N1 N0 N3 N2 N1 Unique to NATALEE3 Total NATALEE opportunity Unique to NATALEE Total NATALEE opportunity NATALEE population More than double the patient opportunity compared to the mBC setting, and compared to monarchE in eBC1 Incident population (estimated)2 US EU5 Stage II (eBC) 66k 66k Stage III (eBC) 15k 24k Stage IV (mBC) 32k 32k Kisqali opportunity4 eBC multibillion USD mBC multibillion USD
Slide 27 — Continuing momentum in mBC expected to lay the foundation for a
Continuing momentum in mBC expected to lay the foundation for a successful launch in eBC NBRx – new to brand prescription. R3M – rolling 3 months. 1. Of CDK4/6 mBC market, US Q1 R3M. 27 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 79 182 160 233 Q1 2022 239 415 Q1 2023 +81% Ex-US US Sales evolution USD m, % cc US mBC NBRx share1 R3M, % April ‘22 April ‘23 13% 31% US mBC Total Writers2 R3M 2.0K April ‘22 April ‘23 3.3K
Slide 28 — Improvement in US coverage has contributed to recent performance
+83% Improvement in US coverage has contributed to recent performance 28 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Over 50% more lives covered to label vs. PY Reflects increasing recognition among payers that a step through Ibrance is unethical in light of Kisqali’s proven OS benefit Recent access wins expected to support continued growth Commercial: Express Scripts (22m lives), Cigna (9.1m), HCSC (6.5m) Medicare: CVS/Aetna (8.7m), Humana (8.1m), Wellcare (5.6m) Strong coverage in both Medicare and Commercial critical for long-term success Commercial increasingly important for eBC, given younger patient population Medicare unrestricted coverage at 86% Commercial unrestricted coverage at 85% +44% 47% 86% 2022 2023 59% 85% 2022 2023 Favorable Unfavorable
Slide 29 — Physicians treating eBC and mBC have significant overlap
Physicians treating eBC and mBC have significant overlap and experience with Kisqali Source: IQVIA Xponent and Claims Data, ending March 2023. HCP – healthcare practitioner. 29 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 6K high prescribing eBC HCPs 5K high prescribing HCPs in common 83% CDK4/6i potential High overlap in HCPs that treat eBC and mBC in the US 6k HCPs contribute 90% of prescriptions in both indications For every 1 patient they see with mBC, they see 10+ with eBC (stages I-III) Majority of high CDK4/6i eBC writers have Kisqali experience 4.5K HCPs with Kisqali experience in the last 12 months (in academic and community settings) in mBC have 70% of eBC CDK4/6i prescribing potential They know the profile of the medicine and adoption is increasing Most patients are in the community setting, where we already have coverage with Kisqali 77% of eBC patients (all stages) are treated in the community setting 6K high prescribing mBC HCPs
Slide 30 — With Kisqali, we can potentially offer at-risk eBC patients protection
With Kisqali, we can potentially offer at-risk eBC patients protection from cancer recurrence with favorable tolerability 30 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Stage II and III HR+/HER2- eBC patients are at significant risk of cancer recurrence, and there’s a need for improved treatment options to keep these patients cancer-free The safety profile of Kisqali was favorable at 400mg with low rates of symptomatic AEs and limited treatment modifications when administered up to 3 years Results were consistent across all secondary endpoints, including distant disease-free survival and recurrence- free survival, with a trend for improved overall survival Kisqali is the first and only CDK4/6 inhibitor to demonstrate a consistent, clinically meaningful benefit across a broad population of patients with HR+/HER2- eBC, regardless of disease stage, menopausal or nodal status Collectively, NATALEE results have the potential to more than double the number of patients who could benefit from treatment with a CDK4/6 inhibitor in the eBC setting
Slide 31 — Agenda
Agenda 31 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 1 Novartis at ASCO 2023 2 Kisqali NATALEE trial in early breast cancer 3 Kisqali: Establishing the CDK4/6 of choice 4 Q&A
Slide 32 — NATALEE results support Kisqali + ET as treatment of choice in a
Favorable safety No new safety signals 400mg dose well tolerated, with limited need for dose reductions (22%) AE-related discontinuations (19%) were mostly protocol-mandated due asymptomatic lab findings Low rates (<1%) of symptomatic AEs such as Gr3 diarrhea and fatigue ►Gr3 VTE and ILD also low (<1%) Robust efficacy HR 95% CI iDFS – total population 0.75 (0.62, 0.91) iDFS – stage II 0.76 (0.53, 1.10) iDFS – stage III 0.74 (0.59, 0.92) iDFS – node negative 0.63 (0.34, 1.16) ►iDFS – node positive 0.77 (0.63, 0.94) ►RFS 0.72 (0.58, 0.88) ►DDFS 0.74 (0.60, 0.91) ►OS 0.76 (0.54, 1.07) NATALEE results support Kisqali + ET as treatment of choice in a broad population of stage II and III patients at risk of recurrence 32 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION
Slide 33 — population could help streamline treatment decisions for
“These landmark results will fundamentally change how we treat patients with stage II and III HR+/HER2- eBC who are in need of new, well-tolerated options that prevent their cancer from coming back. Addressing this unmet need across such a broad patient population could help streamline treatment decisions for healthcare providers and keep many more at-risk patients cancer-free without disrupting their daily lives.” DENNIS J. SLAMON M.D., Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center and Chairman and Executive Director of Translational Research In Oncology (TRIO) and NATALEE trial lead investigator
Slide 34 — Appendix
Appendix
Slide 35 — Novartis oncology pipeline focused in areas of high unmet need
Solid Tumors Hematology Disease areas (Selected) Breast Cancer Prostate Cancer Lung Cancer Non-Hodgkin’s Lymphoma Myeloid Cancers Non-Malignant Hematology Commercial assets Pipeline assets and opportunities Novartis oncology pipeline focused in areas of high unmet need where we have deep expertise AML / MDS – Acute Myeloid Leukemia / Myelodysplastic Syndrome. HR+/HER2− – hormone receptor-positive / human epidermal growth factor receptor 2-negative. NSCLC – non-small cell lung cancer. mPDAC – metastatic pancreatic ductal adenocarcinoma. mCRC – metastatic colorectal cancer. PNH – paroxysmal nocturnal hemoglobinuria. aHUS – atypical hemolytic uremic syndrome. 35 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION Leveraging advanced therapy platforms such as radioligand therapy, cell therapy, and differentiated biologics Kisqali Adjuvant HR+/HER2- BC JDQ433 NSCLC Pluvicto Prostate cancer NIS793 1L mPDAC / 1L mCRC Iptacopan PNH, aHUS YTB323 Non-Hodgkin's Lymphoma Ianalumab Multiple indications PHE885 Multiple Myeloma
Slide 36 — Pluvicto: Additional analyses of VISION data further support clinical
Pluvicto: Additional analyses of VISION data further support clinical adoption in mCRPC; Ph3 PSMAddition study underway in mHSPC 1. As per blinded independent central review (BICR). PSMA – prostate-specific membrane antigen. RR – response rate. mHSPC – metastatic hormone sensitive prostate cancer. PFS – progression free survival. FU – follow-up. PD – progressive disease. PSMAddition: Ph3 trial assessing Pluvicto + SOC vs. SOC alone in mHSPC patients New analyses of VISION data in mCRPC further support clinical adoption N=~1126; primary analysis after ~418 rPFS events1 Data readout and submission anticipated in 2024 Updated results of a VISION dosimetry sub-study showed that in addition to the good safety profile and low radiotoxicity of Pluvicto in at-risk organs, tumor dosimetry results were consistent with previously published estimates Post-hoc multivariate analysis of VISION data identified more predictive markers for long-term outcomes (e.g. OS and rPFS) than in previous models, helping physicians identify appropriate patients for Pluvicto NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 36
Slide 37 — JDQ443: Updated data from KontRASt-01 study show 55% ORR at
JDQ443: Updated data from KontRASt-01 study show 55% ORR at recommended dose and favorable safety profile for combinations ORR – overall response rate. NSCLC – non-small cell lung cancer. TRAE – treatment related adverse events. ALT – alanine transaminase. AST – aspartate aminotransferase. Safety and tolerability profile supports potential for combination strategies JDQ443 is a structurally unique KRASG12C inhibitor that exhibits antitumor activity in NSCLC 84 pts were treated with JDQ443 monotherapy, orally, continuously, across three cohorts (dose escalation, dose expansion and food effects) Median age was 61 years; median prior lines of therapy was 3 Indications included NSCLC (n = 38), CRC (n = 42) and others (n = 4) Median duration of exposure was 14.6 weeks for all patients and 15.1 weeks for patients treated at RD of 200 mg BID JDQ443 doublet combinations with tislelizumab (anti-PD-1) and TNO155 (SHP2i) in KontRASt-01 have completed dose escalation; now in Ph2 dose expansion TRAEs were low-frequency, low-grade events No Grade 4/5 TRAEs No nausea, vomiting, or diarrhea higher than Grade 2 ALT/AST Grade 2/3 elevation events were rare & of limited duration NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 37 TRAEs among patients treated at RD 200mg BID (n=56) Among response evaluable patients with NSCLC, confirmed ORR was 54.5% (6/11 pts) at 200 mg BID and 41.7% (10/24 pts) across dose levels Abstract data; final data to be presented on Tuesday
Slide 38 — PHE885: 100% ORR at active doses with no unexpected safety
PHE885: 100% ORR at active doses with no unexpected safety findings in Ph1; Ph2 study underway in r/r MM 1. Engels B, et al. Blood. 2021;138(supp 1): Abstract 2949. 2. Barba P, et al. Blood. 2022;140(suppl 1):1056-1059. 3. Sperling AS, et al. European Hematology Association (EHA) 2022 Congress; June 9-12, 2022; Vienna, Austria. Poster P1446. ORR – overall response rate. MM – multiple myeloma. CRS – cytokine release syndrome. 38 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION PHE885 achieved 100% ORR at active doses; clinical responses deepen over time T-Charge platform – quick production with potential for outstanding clinical impact No unexpected safety findings, including no reports of parkinsonism or delayed neurotoxicity PHE885 reliably expanded in vivo and showed prolonged persistence with preserved T-cell stemness T-Charge™ Preserves T-cell stemness1-3 maintaining the stem and central memory T-cells3 Enhances in vivo expansion2,3 with potential to improve efficacy, and increase persistence and durability of response Has <2-day manufacturing time2,3 and aim of <10-day door-to-door time in the United States T-Charge manufacturing preserves early memory phenotype in the PHE885 final product PHE885 was successfully produced for all patients with unprecedented short manufacturing times
Slide 39 — Novartis oncology key mid-term pipeline milestones on track
Novartis oncology key mid-term pipeline milestones on track 39 NOVARTIS ASCO EVENT | JUNE 4, 2023 | INVESTOR PRESENTATION 2023 2024 2025 Pluvicto mHSPC PSMAddition Ph3 readout Ianalumab 1L and 2L ITP VAYHIT1 and -2 Ph3 readouts Iptacopan PNH FDA submission in H1 Pluvicto mCRPC (post-ARDT, pre-taxane) PSMAfore FDA submission in H2 Scemblix 1L CML-CP ASC4FIRST Ph3 readout YTB323 1L HR LBCL Ph2 readout AAA603 Breast cancer Ph1 readout in H2 Nisevokitug (NIS793) 1L mPDAC daNIS-2 Ph3 readout