Novartis Investor Presentation

Made public by

sourced by PitchSend

1 of 36

Creator

Novartis logo
Novartis

Category

Healthcare

Published

September 22, 2022

Slides

Transcriptions

#11 New Novartis: Our strategy Our focus Our priorities Conclusion Abbreviations Meet Novartis Management Novartis Investor Relations September 22, 2022 NOVARTIS Reimagining Medicine#2New Novartis: Our strategy Our focus Our priorities Conclusion Abbreviations Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek," "look forward,” “believe,” “committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding the potential completion of the proposed spin-off of Sandoz; regarding the future commercial performance of Novartis or of Sandoz; regarding any potential strategic benefits, synergies or opportunities as a result of the proposed spin-off; regarding discussions of strategy, plans, expectations or intentions; regarding our ability to deliver improved financial results, continuing development of to successfully launch new products and new indications for existing products, to deliver high value innovation, or improve access to patients; or regarding potential benefits resulting from our organizational changes announced in April. 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 the proposed spin-off will be completed in the expected form or within the expected time frame or at all. Nor can there be any guarantee that Novartis or a separate Sandoz business will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of these actions. Neither can there be any guarantee that shareholders will achieve any particular level of shareholder returns. Nor can there be any guarantee that the proposed spin-off of Sandoz will maximize value for shareholders, or that Novartis or any of its divisions, or a separate Sandoz business, will be commercially successful in the future, or achieve any particular credit rating or financial results. Neither can there be any guarantee that we will be able to improve our financial results, successfully launch new products and new indications for existing products, deliver high value innovation or improve access to patients. Nor can there be any guarantee that our organizational changes announced in April will realize any or all of the expected benefits, or within any particular time frame. In particular, our expectations could be affected by, among other things: an unexpected failure to complete, or unexpected delays in completing, the necessary actions for the proposed spin-off, or to obtain the necessary approvals to complete these actions; the potential strategic benefits, synergies or opportunities expected from the proposed spin-off may not be realized or may take longer to realize than expected; regulatory actions or delays or government regulation generally; the inherent uncertainty in predicting shareholder returns; the successful separation of Sandoz from Novartis and the timing of such separation; potential adverse reactions to the proposed spin-off by customers, suppliers, strategic partners or key Sandoz personnel and potential difficulties in maintaining relationships with such persons; a failure to improve our financial results, to successfully launch new products and new indications for existing products, to deliver high value innovation, or to improve access to patients; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; 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. Implementation of the proposed separation of Sandoz by way of a 100% spin-off is subject to certain conditions, including Novartis shareholder approval and applicable Novartis Euroforum and local employee information and/or consultation. Nuplazid® is a registered trademark of Acadia Pharmaceuticals Inc. Aduhelm® is a registered trademark of Biogen. 2 Novartis Investor Presentation | September 22, 2022 U NOVARTIS | Reimagining Medicine#3> New Novartis: Our strategy Our focus Our priorities Conclusion Abbreviations New Novartis: Our strategy Deliver high-value medicines that alleviate society's greatest disease burdens through technology leadership in R&D and novel access approaches Our focus 5 core Therapeutic Areas¹ Cardiovascular, Immunology, Neuroscience, Solid Tumors, Hematology 2+3 technology platforms Chemistry, Biotherapeutics XRNA, Radioligand, Gene & Cell Therapy 4 priority geographies US, China, Germany, Japan 1. Other TAs opportunistically 3 Novartis Investor Presentation | September 22, 2022 foo Our priorities Accelerate growth Deliver high-value medicines (including launch excellence) Deliver returns Embed operational excellence Strengthen foundations Unleash the power of our people Scale data science and technology Build trust with society U NOVARTIS | Reimagining Medicine#4> New Novartis: Our strategy Our focus Our priorities Conclusion Abbreviations Focused Innovative Medicines company consistently delivering strong operational performance 2014 | Pre-portfolio transformation 2017 | Pre-Alcon spin-off +6% 42.0 AH Vx OTC 31.8 IM Sales Alcon USD billion, % CAGR CC Alcon Sandoz IM IM Sandoz FY 2016 FY 2021 + 10% 15.2 10.1 IM Core Oplnc 2019 Post-Alcon spin-off 2023 | Post-Sandoz spin-off USD billion, % CAGR CC FY 2016 FY 2021 Sandoz IM 4 Novartis Investor Presentation | September 22, 2022 IM 36.2% 31.6% IM Core Margin % FY 2016 FY 2021 1 | NOVARTIS | Reimagining Medicine#5New Novartis: Our strategy > Our focus Core Therapeutic Areas Technology platforms Priority geographies Capital allocation / structure Our priorities Conclusion Abbreviations Our focus 5 33 15 Novartis Investor Presentation | September 22, 2022 INVIAN VITA NOVARTIS Reimagining Medicine#6New Novartis: Our strategy Our focus > Core Therapeutic Areas Technology platforms Priority geographies Capital allocation / structure Our priorities Conclusion Abbreviations Focused on 5 core Therapeutic Areas... Select examples Cardiovascular Disease areas ■ Heart failure & hypertension ■ Atherosclerosis Commercial assets Entresto* sacubitril/valsartan LEQVIO® Immunology ■ Psoriasis ■ Psoriatic arthritis ◉ Spondylitis/Spondylarthritis ■ Hidradenitis suppurativa ■ CSU Sjögren's / SLE/LN Cosentyx secukinumab ILARIS (canakinumab) 150 mg subcutaneous injection 9 Neuroscience ◉ Multiple sclerosis ◉ Spinal muscular atrophy Neurodegeneration, incl. Huntington's, Parkinson's, ALS Kesimpta (ofatumumab) MAYZENT. (siponimod) tablets GILENYA (fingolimod) Capsules Solid Tumors Breast and Women's cancer ■ Prostate cancer ◉ Lung cancer 1. Core TAs Hematology ■ Non-Hodgkin's lymphoma Non-malignant hematological - Immune thrombocytopenia ■ Acute myeloid leukemia / Myelodysplastic syndrome zolgensma Taimovig (erenumab-acce KISQALI PLUVICTO™ ribociclib Tafinlar + Mekinist (dererle niby PIQRAY* (alpelisib) tablets (trainelinib) Advanced LUTATHERA KYMRIAH (tisagenlecleucel) SCEMBLIX® (asciminib) 20 mg. 40 mg tablets PROMACTA JAKAVI (eltrombopag) ruxolitinib Pipeline assets and opportunities Iptacopan (LNP023) C3G, IgAN Pelacarsen (TQJ230) CVRR-Lp(a) Leqvio CVRR-LDLC Cosentyx Multiple indications Remibrutinib (LOU064) CSU lanalumab (VAY736) Sjögren's, SLE, LN Ligelizumab (QGE031) Food Allergy Remibrutinib (LOU064) MS Zolgensma (AVXS-101 IT) SMA IT Branaplam (LMI070) Huntington's Kisqali Adjuvant HR+/HER2- BC TNO155, JDQ433 NSCLC; Colorectal Cancer; Combos NIS793 1L MPDAC / 1L MCRC Iptacopan (LNP023) PNH, aHUS Sabatolimab (MBG453) MDS, AML lanalumab (VAY736) Multiple indications YTB323 DLBCL TA-x (incl. Ophtha, Resp and other assets) not included in the above list. Pelacarsen is licensed from lonis Pharmaceuticals, Inc. 6 Novartis Investor Presentation | September 22, 2022 & NOVARTIS | Reimagining Medicine#71. Core TAs New Novartis: Our strategy Our focus > Core Therapeutic Areas Technology platforms Priority geographies Capital allocation / structure Our priorities Conclusion Abbreviations ...with the largest growth potential and existing Novartis expertise TA size and growth contribution Illustrative. Bubble size = 2022-27 revenue contribution to growth, $bn. 250 <0% 0-5% 5-10% = negative contribution to growth. >10% 7 50 2022 Market Size ($bn) 150 200 KX 100 LA 0 C I EL F E D J A A Oncology B Central Nervous System C Immunology (incl. Dermatology) D Cardiovascular 2 E Endocrine F Blood G Respiratory B H Sensory Organs C J Gastro-Intestinal Genito-Urinary L K Systemic Anti-Infectives Musculoskeletal Within each Therapeutic Area Clear disease area priorities ✓ Promising lead assets ☐ Focus on lifecycle management Expected Growth (% CAGR 2022-27) Source: Evaluate Pharma (July, 15 2022). Note: Chart excludes 'Various' and 'Other Rx and OTC Pharma' segments; Evaluate Pharma data not pro-forma for Consumer Health business separation for J&J and GSK. 1. Reflects latest setbacks in Alzheimer's trials (Athira Pharma's fosgonimeton), FDA's negative opinion for Acadia's NuplazidⓇ, failed launch of Biogen's AduhelmⓇ and failed read out of Roche's crenezumab. 2. Includes obesity Novartis Investor Presentation | September 22, 2022 1 | NOVARTIS | Reimagining Medicine#8New Novartis: Our strategy Our focus > Core Therapeutic Areas Technology platforms Priority geographies Capital allocation / structure Our priorities Conclusion Abbreviations Strong positioning in Cardiovascular, the leading cause of death and disability 1. Core TAs - Cardiovascular Phase 1 Phase 2 Phase 3 Registration 8 Novel approaches that aim to improve HF outcomes Dyslipidemia treatments that improve CV morbidity/mortality in identifiable high-risk groups with high unmet need Population health approach, initially with NHS. agreement for broad and rapid access to Leqvio® Chronic and acute renal specialty indications with high unmet need and limited/no targeted therapies Disease modifying therapies for metabolic disorders Selected compound (indication) LeqvioⓇ (Hyperlipidemia) LeqvioⓇ (CVRR-LDLC) Leqvio® (Primary prevention)1 Pelacarsen (Lp(a)) XXB750 (Cardiovascular diseases) Iptacopan (IgAN) Iptacopan (C3G) Disease area Cardio Renal Iptacopan (IMN) Iptacopan (Others) TIN816 (S-AKI)² Metabolic MBL949 (Obesity) Note: Bars in Gantt chart indicate current phase of development 1. Phase 3 not yet started 2. Phase 2 initiating Novartis Investor Presentation | September 22, 2022 U NOVARTIS | Reimagining Medicine#9New Novartis: Our strategy Our focus > Core Therapeutic Areas Technology platforms Priority geographies Capital allocation / structure Our priorities Conclusion Abbreviations Full pipeline across Immunology covering Rheumatology, Dermatology and Allergy 1. Core TAs - Immunology Phase 1 Phase 2 Phase 3 Registration 6 Focus on areas of high unmet need in Rheumatology, Dermatology and Allergy: Sjögren's, Osteoarthritis, Food Allergy, Hidradenitis Suppurativa, Lupus Nephritis, Atopic Dermatitis Developing novel and differentiated MoAs: lanalumab: Fully human monoclonal antibody binding to and blocking the function of the BAFF receptor Remibrutinib: Oral, covalent BTK inhibitor targeting immune cell signaling Disease area Rheumatology Dermatology Allergy Selected compound (indication) Cosentyx® (300 mg Al) CosentyxⓇ (IV PSA/IV axSpA/LN/GCA) lanalumab (SjS/LN) lanalumab (SLE) LNA043 (Knee OA) Remibrutinib (SjS) MHV370 (SjS/SLE) Cosentyx® (HS) Remibrutinib (CSU) CosentyxⓇ (LP) Remibrutinib (HS) MAS825 (HS) XolairⓇ (FA) Ligelizumab (FA) Note: Bars in Gantt chart indicate current phase of development 1. Phase 2 initiating Novartis Investor Presentation | September 22, 2022 Remibrutinib (FA)1 U NOVARTIS | Reimagining Medicine#10Leadership across 3 next-generation technology platforms... 2. Technology platforms New Novartis: Our strategy Our focus Core Therapeutic Areas > Technology platforms Priority geographies Capital allocation / structure Our priorities Conclusion Abbreviations Shift towards biologics and advanced technology platforms Proportion % of IM sales by platform Outlook illustrative Leadership across 3 next-generation technology platforms Gene & Cell therapy 5% 22% 73% 2020 Small molecules Biologics RLT XRNA¹ Gene Cell Expand platforms Existing commercial assets zolgensma® >KYMRIAH LUTATHERAⓇ LEQVIO® LUXTURNA PLUVICTO™ Scale biologics Focus on new approaches to address previously intractable targets (e.g. TPD) 2030 3 next-generation technology platforms Key focus Novel cargos, Next targeting & switchable expression generation of CAR-Ts & manufacturing efficiency Additional solid tumors Build up siRNA capabilities & explore new approaches in RNA # of projects² 19 14 9 11 Expected next filing 2025 2025 2023 2025 1. XRNA includes RNA targeting LMWS, ASOS, siRNA, mRNA cancer vaccines 2. Exploratory to Ph1/2 (July 2022) 10 Novartis Investor Presentation | September 22, 2022 U | NOVARTIS | Reimagining Medicine#11New Novartis: Our strategy Our focus Core Therapeutic Areas > Technology platforms Priority geographies Capital allocation / structure Our priorities Conclusion Abbreviations leveraging the strengths across our organization Depth and breadth across 2+3 platforms ~70 projects¹ Technology platforms 2. Technology platforms Manufacturing scale and expertise Europe North Americas Asia 1 Exploratory to Ph1/2 Development and regulatory experience 를 11 Novartis Investor Presentation | September 22, 2022 ALL ULBUL 0019 CAR TO >30 manufacturing sites globally Strong supply chain delivering quality & safety (100% YTD favorable HA inspections) Meeting sustainability targets Global footprint Commercialization expertise KYMRIAH LEQVIO® PLUVICTO™ LUTATHERAⓇ zolgensma LUXTURNA U | NOVARTIS | Reimagining Medicine#12New Novartis: Our strategy Our focus Core Therapeutic Areas > Technology platforms Priority geographies Capital allocation / structure Our priorities Conclusion Abbreviations Building the industry-leading RLT platform Established leadership in RLT, category creator and positioned as the go-to partner for collaborations Robust manufacturing delivering safety and quality ■ 4 manufacturing facilities: Ivrea (Italy), Milburn (US), Zaragoza (Spain) & Indianapolis (US, opening 2023) At scale manufacturing & "just-in-time" production/delivery On track for additional non-carrier added isotope production Strong commercial execution with >500 centers and >16,000 patients treated Leading with the science ▪ 4 ongoing registrational studies (next readout PSMAfore Q4'22) ■ 8 dedicated early discovery projects Selected compound (indication) Lutathera (1L GEP-NET) Lutathera (Pediatrics + PPGL)1 Lutathera (GBM)² Lutathera (ES-SCLC)² Pluvicto (mHSPC) Pluvicto (mCRPC) 225AC-PSMA-617 (PCa+bone metastases) NeoB (multi tumor) 1. PPGL, is an exploratory cohort of NETTER-P 2. Phase 1/2 12 Novartis Investor Presentation | September 22, 2022 2. Technology platforms - RLT Phase 1 Phase 2 Phase 3 U | NOVARTIS | Reimagining Medicine#13New Novartis: Our strategy Our focus Core Therapeutic Areas Technology platforms > Priority geographies Capital allocation / structure Our priorities Conclusion Abbreviations 3. Priority geographies Geographic focus - organically building the US to a top 5 player 2027 ambition 2021 #10 > #5 1 #1 1 How? "US first" mindset for global functions/units (NIBR, GDD, IM) 2 3 Reporting directly into Executive Committee US TPPS prioritized #1 2 #5 > #3 5 2 #4 #3 1. Priority geography - Germany 2. Rank among pharmaceutical multinational companies 13 Novartis Investor Presentation | September 22, 2022 4 Representation in all governance bodies Focus on capability building & talent (incl. US focused talent in global roles) 6 Increase of US-patient share in trials & NOVARTIS | Reimagining Medicine#14New Novartis: Our strategy Our focus Core Therapeutic Areas Technology platforms Priority geographies > Capital allocation/structure Our priorities Conclusion Abbreviations Remain disciplined and shareholder focused in our capital allocation priorities Investing in the business Investments in organic business USD 9bn R&D 20211 4. Capital allocation / structure Returning to shareholders USD 53bn distributed (85% of FCF) 2017-2021 Growing annual dividend in CHF USD 7.5bn paid out in 2022; DPS increase of +3.3% CHF; +4.1% USD USD 1.4bn capital investments 2021 Substantial cash generation Value-creating bolt-ons Share buybacks USD 30bn (approx.) 2017-2021 USD 15bn ongoing, USD 8.2bn to be executed² Sandoz separation is expected to have limited impact on our credit rating, providing continued flexibility for future capital allocations 1. Core R&D actuals 2021 2. As of August 31 2022 14 Novartis Investor Presentation | September 22, 2022 1 | NOVARTIS | Reimagining Medicine#1515 New Novartis: Our strategy Our focus Core Therapeutic Areas Technology platforms Priority geographies > Capital allocation/structure Our priorities Conclusion Abbreviations Our strong capital structure supports flexibility for strategic investments and distributions Our strong capital structure positions us well within our peer group .. Credit rating positioning and the current low leverage provides flexibility for further capital allocation Q2 2022 leverage (net debt / EBITDA) Aaa MOODY'S Aa1 Aa2 Aa3 A1 A2 A3 Baa1 Baa2 Novartis S&P Global Ratings Peers Novartis 0.4 -0.1 0.7 0.7 4. Capital allocation / structure 3.5 2.5 2.3 2.1 1.6 1.6 1.5 1.2 1.0 I 0.9 Вааз BBB- BBB BBB+ A- A A+ AA- AA AA+ AAA Average 1.4 Strong FCF generation coupled with strong balance sheet / low leverage provide flexibility for future value-creating bolt-on M&A or further shareholder distributions Source: Bloomberg; ratings as of September 16, 2022; leverage calculated with net debt (gross debt incl. lease liabilities minus total liquidity) and trailing 12-month EBITDA Novartis Investor Presentation | September 22, 2022 1 | NOVARTIS | Reimagining Medicine#1616 SOC Outgrowth Medium 5.0-17 -0003ne 133 New Novartis: Our strategy Our focus > Our priorities Improved financials Launch excellence High-value innovation Our priorities Operational excellence Strengthen foundations Conclusion Abbreviations C Qube Nav1.1/1.4/1.5/17 60 mM sodium Novartis Investor Presentation | September 22, 2022 5mM calci 73 m TO U NOVARTIS | Reimagining Medicine Pipet-Lite XLS#17New Novartis: Our strategy Our focus Our priorities > Improved financials Launch excellence High-value innovation Operational excellence Strengthen foundations Conclusion Abbreviations - Continuing to deliver improved financials – sales, core margin, free cash flow and return on invested capital New-Novartis expectations (illustrative only) Sales % CC, CAGR +4% Incremental benefit from Sandoz spin-off Free Cash Flow % of sales 2021 2027 Core Operating Income Margin (corporate costs absorbed) 2021 2027 Return on Invested Capital ~40%+ 2021 2027+ 2021 2027 17 Novartis Investor Presentation | September 22, 2022 1. Improved financials > IM expected to grow sales, margin and FCF (% of sales) > Margin targets includes absorbing corporate costs Sandoz spin-off will result in incremental growth for: - - Core operating income margin FCF (% of sales) - Return on invested capital > New-Novartis remains committed to capital allocation priorities, with growing (CHF) annual dividend U | NOVARTIS | Reimagining Medicine#18New Novartis: Our strategy 2. Launch excellence Existing in-market brands with multi-bn potential are the foundations Our focus Our priorities Improved financials > Launch excellence High-value innovation Operational excellence Strengthen foundations Conclusion Abbreviations Q2 2022 sales annualized Q2 growth in cc 18 Cosentyx® USD 5.1 bn +12% CEZ K KK KL Entresto Ⓡ zolgensma® KISQALIⓇ Kesimpta® LEQVIO® USD 4.5 bn USD 1.5 bn USD 1.2 bn USD 1.0 bn USD 0.1 bn +33% +26% +43% +270% nm Peak sales USD >7bn US LOE 2029+ Peak sales USD >5bn US LOE 2025+ Peak sales multi-bn¹ US LOE 2031+ Peak sales multi-bn US LOE 2031+ Peak sales multi-bn US LOE 2031+ nm - not meaningful. LOE - Loss of exclusivity. All growth rates in constant currencies (cc). US LoEs are estimated based on relevant patents; further extensions possible. 1. Including ZolgensmaⓇ IT. Novartis Investor Presentation | September 22, 2022 Peak sales multi-bn US LOE 2036+ 1 | NOVARTIS | Reimagining Medicine#192. Launch excellence New Novartis: Our strategy Our focus Our priorities Improved financials > Launch excellence High-value innovation Operational excellence Strengthen foundations Conclusion Abbreviations Recently launched Pluvicto™ and Scemblix® add potential upsides PLUVICTO™ US launch beating internal expectations ☐ Manufacturing issues remediated Permanent A code granted in Jul, effective Oct More than 50% of insured lives covered (across Medicare, Medicaid and private payers) >100 target RLT sites operational Additional Ph3 studies in earlier settings on track (pre-taxane mCRPC and mHSPC) SCEMBLIX' continues strong US uptake (asciminib) 20 mg. 40 mg tablets $31m Q2 sales driven by patients with resistance/intolerance to other TKIs 44% 3L+ new patient share1 16% NBRx share across CML lines of treatment¹ 1L Ph3 study (1L) enrolling ahead of plan EC approval and rollout ongoing across ex- US markets 1. Source: IQVIA Market Sizing "Source of Business", "Product Summary" reports, June 2022 19 Novartis Investor Presentation | September 22, 2022 1 | NOVARTIS | Reimagining Medicine#20New Novartis: Our strategy Our focus Our priorities Improved financials Launch excellence > High-value innovation Operational excellence Strengthen foundations Conclusion Abbreviations 3. High-value innovation Industry-leading development engine; now prioritizing value per asset Total NME approvals by company (1999-2021)1 42 30 NDA 34 ✓ Prioritization: Active prioritization for core Therapeutic Areas Commercial focus: Increased commercial input into R&D Development/TPP: US TPP prioritized, portfolio prioritization focusing on high-value assets Operational efficiency: Strengthen efficiency by simplifying structures; further integrating R&D to accelerate key early assets People: Maintain/strengthen high-performing organization of competent and engaged talent 28 23 18 ✓ 14 12 BLA ✓ Novartis Company A Company B Company C Company D Company E 1. US FDA NME approvals 20 Novartis Investor Presentation | September 22, 2022 U | NOVARTIS | Reimagining Medicine#21New Novartis: Our strategy Our focus Our priorities Improved financials Launch excellence > High-value innovation Operational excellence Strengthen foundations Conclusion Abbreviations 3. High-value innovation Key near-term readouts (2023 - 2024) for high value assets... Kisqali NATALEE trial in adjuvant breast cancer testing both high-risk and intermediate-risk patients with final Phase 3 readout expected in 2023 Iptacopan APPLY-PNH trial with expected Phase 3 readout in H2 2022, followed by other indications in 2023 Pluvicto PSMAfore trial in mCRPC (post-ARDT, pre-taxane) with expected readout end of 2022 / early 2023 PSMAddition trial in mHSPC with expected readout in 2024 21 21 Remibrutinib CSU Phase 3 REMIX-1 and -2 trials with expected readout in 2024 and Multiple sclerosis Phase 3 REMODEL-1 and -2 trials with expected readout in 2025 Scemblix 1L CML-CP trial with expected readout in 2024 Unprobabilized peak sales of indications in late-stage development: > USD 1bn > USD 2bn > USD 3bn Novartis Investor Presentation | September 22, 2022 1 | NOVARTIS | Reimagining Medicine#22New Novartis: Our strategy Our focus Our priorities Improved financials Launch excellence > High-value innovation Operational excellence Strengthen foundations Conclusion Abbreviations 3. High-value innovation ...from a catalyst rich pipeline across our core Therapeutic Areas Catalyst readouts significantly increase in 2024-2025 timeframe Key submission enabling readouts 2022-2023 2024-2025 2026-2027 22 Iptacopan C3G Iptacopan IgAN Pelacarsen CVRR CosentyxⓇ GCA Ligelizumab Remibrutinib Food allergy CSU Remibrutinib ZolgensmaⓇ SMA IT KisqaliⓇ adj BC Pluvicto mCRPC Pre-taxane Iptacopan PNH MS JDQ443 2/3L NSCLC NIS793 Pancreatic cancer PiqrayⓇ TNBC and 1L HER2+ aBC ScemblixⓇ 1L CML-CP PluvictoⓇ MHSPC Ociperlimab¹ 1L PDL1hi and 1L LA NSCLC Iptacopan aHUS Sabatolimab MDS LeqvioⓇ Secondary Prevention lanalumab Sjögren's lanalumab Lupus nephritis Cosentyx® Lupus nephritis lanalumab Hematology indications In scope: Selected top assets (>1bn in development) with programs in phase 3 (or pivotal trial submission enabling) 1. Option deal, BeiGene study, PD-L1 High and Locally Advanced NSCLC Novartis Investor Presentation | September 22, 2022 Cardiovascular Immunology Neuroscience Solid Tumors Hematology & NOVARTIS | Reimagining Medicine#23New Novartis: Our strategy Our focus Our priorities Improved financials Launch excellence > High-value innovation Operational excellence Strengthen foundations Conclusion Abbreviations 3. High-value innovation Potential positive NATALEE readout offers significant upside to sales growth KisqaliⓇ Ph3 OS results in 1L mBC MONALEESA-2 Median OS Risk reduction 24% 63.9 months1 NATALEE adjuvant study Ribociclib 400mg/day 3 weeks on/1 week off RIB+ 36 months (-39 cycles) 36 months 60 months To date not reached first interim; expect filing in 2023 23 HR++HER2-eBC ET MONALEESA-7 R Pre- and post- menopausal 1:1 Risk reduction 24% 58.6 months2 Anatomic Stage II & III N=5000 ET MONALEESA-3 Risk reduction 33% 67.6 months3 NSAI 60 months [+ goserelin in pre-menopausal women & men] 60 months Indication Early breast cancer NSAI 60 months [+ goserelin in pre-menopausal women & men] Potential Population DOO >USD 1bn O >USD 2bn >USD 3bn ■ Proven OS benefit across all three Phase 3 clinical trials ☐ ■ Same OS benefit regardless of menopausal status, hormone therapy partner, or dose modifications4 ■ Maintains clinical benefit even after prior CDK4/6i use5 Fully enrolled as of April 2021 Primary analysis planned at 500 iDFS events, expected in 2023 Interim analyses at 70% and 85% 218K (US & EU)6 1. In months vs. vs 51.4, P value: 0.008. Reference: Hortobagyi, GN et al., 2022 2. vs 51.8. Reference: Lu, YS et al., 2022 3. vs 51.4. Reference: Neven, P et al., 2022 4. Based on an analysis of MONALEESA-2, -3 and -7 the MAINTAIN IIT, Patients who received Kisqali and changed their ET in 2L had PFS twice as long as patients who only changed their ET 6. eBC Patient - Adjuvant Breast Cancer Opportunity Assessment June 2020 5. Based on Novartis Investor Presentation | September 22, 2022 1 | NOVARTIS | Reimagining Medicine#24New Novartis: Our strategy Our focus Our priorities Improved financials Launch excellence High-value innovation > Operational excellence Strengthen foundations Conclusion Abbreviations Strengthening integration within R&D to accelerate key early programs Selected assets with integrated plans MBL949 (Obesity related diseases) TIN816 (S-AKI) ATP Modulator1 XXB750 (Cardiovascular diseases) lanalumab (LN) BAFF-R inhibitor MAS825 (Hidradenitis Suppurativa) BLZ945 (Amyotrophic lateral sclerosis) CSF-1R inhibitor JDQ443 (NSCLC) KRAS inhibitor 177Lu NeoB (Solid Tumors) Radioligand therapy MGY825 (NSCLC) Phase 1 Phase 2 Phase 3 4. Operational excellence Cardiovascular Immunology Neuroscience Solid Tumors 24 24 Note: Bars in Gantt chart indicate current phase of development 1. Phase 2 initiating Novartis Investor Presentation | September 22, 2022 & NOVARTIS | Reimagining Medicine#25New Novartis: Our strategy Our focus Our priorities Improved financials Launch excellence High-value innovation > Operational excellence Strengthen foundations Conclusion Abbreviations Organizational changes announced in April on track to deliver operational excellence and drive growth... Integrated IM business, with US and International at ECN 4. Operational excellence 25 New Strategy & Growth function Single Operations unit and integrated global G&A functions Short-term Accelerate growth Strong pipeline management, business development Accelerate technology transformation, create novel digital solutions, increase productivity More agile M&S resource allocation to top brands Mid- to long-term Innovation and sales growth Above peer median sales growth Bringing Novartis into top 5 in the US Productivity and focus for R&D and business development Simpler, faster, more flexible decision making Novartis Investor Presentation | September 22, 2022 1 | NOVARTIS | Reimagining Medicine#26New Novartis: Our strategy Our focus Our priorities Improved financials Launch excellence High-value innovation > Operational excellence Strengthen foundations Conclusion Abbreviations 4. Operational excellence ...and on track to deliver operational efficiencies Reorganization on track Savings of ~USD 1.5bn to be fully embedded by 2024 ~USD 1.5bn Organizational changes ☑~USD 1.5bn in savings. ✓ People perspective. Integrated Operations unit synergies Simplification of M&S structure (non-customer-facing) 26 Novartis Investor Presentation | September 22, 2022 Streamlining G&A functions 2022 2023 2024 Minimal impact, offsetting energy costs and inflation pressure in supply chain & NOVARTIS | Reimagining Medicine#27New Novartis: Our strategy Our focus Our priorities Improved financials Launch excellence High-value innovation > Operational excellence Strengthen foundations Conclusion Abbreviations Refreshing our leadership team Marie-France Tschudin* President, Innovative Medicines International & Chief Commercial Officer Richard Saynor Chief Executive Officer, Sandoz Vas Narasimhan Chief Executive Officer Klaus Moosmayer Chief Ethics, Risk & Compliance Officer Fiona Marshall* President, Novartis Institutes for BioMedical Research (NIBR) Executive Committee of Novartis * Recent role or appointment change 27 27 Novartis Investor Presentation | September 22, 2022 Steffen Lang* President, Operations Rob Kowalski Chief People & Organization Officer Shreeram Aradhye* President, Global Drug Development & Chief Medical Officer Victor Bulto* President, Innovative Medicines US Ronny Gal* Chief Strategy & Growth Officer Karen Hale Chief Legal Officer Harry Kirsch Chief Financial Officer 4. Operational excellence 1 | NOVARTIS | Reimagining Medicine#28New Novartis: Our strategy Our focus Our priorities Improved financials Launch excellence High-value innovation Operational excellence > Strengthen foundations Conclusion Abbreviations Continue to strengthen foundations including improving access for patients Broad access to innovation Material ESG factors 1. Patient health & safety 2. Access 3. Innovation 4. Ethical business practices Access 100% of launches with access strategy (Access Principles) Innovative pricing and access models (SSA and EMB) Sustainability-linked bond targets. on track (LMICS, 2025): - 3x patient reach¹ with strategic innovative therapies - 1.5x patient reach¹ through flagship programs Innovation Innovative therapies reaching more LMIC patients faster Neglected tropical diseases Clinical trial diversity 5. Strengthen foundations Other priority areas Human capital: Diversity targets Environment: Net zero by 2040 Ethics: High ethical standards and zero tolerance Leading position in third-party ESG ratings 1. Results in improved population health and substantial social impact 28 Novartis Investor Presentation | September 22, 2022 1 | NOVARTIS | Reimagining Medicine#29New Novartis: Our strategy Our focus Our priorities > Conclusion Abbreviations Conclusion U NOVARTIS | Reimagining Medicine 29 Novartis Investor Presentation | September 22, 2022#30New Novartis: Our strategy Our focus Our priorities > Conclusion Abbreviations Novartis is a focused company playing in an attractive market, with a differentiated portfolio and strong global footprint Attractive market & financials >$1 tn IM market Cardiovascular, Immunology, Neuroscience, Solid Tumors and Hematology - attractive TAS +4% sales growth (2021-2027, % cc, CAGR) ~40%+ core margin (2027+) Shareholder focused capital allocation Differentiated portfolio 5 core TAS Emerging leadership with clear disease area priorities Strong mid/late-stage pipeline Focused on high value innovation 3 next-generation platforms Leadership across technology platforms Expanding % IM sales from biologics and technology platforms Strong global footprint ~280 m patients¹ reached in 140 countries Building US to a top 5 player and reinforcing international leadership Leading R&D organization Industry leading development engine $9 bn in R&D spend² >30 manufacturing sites Incl. leading capabilities in Cell, Gene, and Radioligand Therapies 1. Including IM + Global Health 2021 2. Core R&D actuals 2021 30 Novartis Investor Presentation | September 22, 2022 U NOVARTIS | Reimagining Medicine#31New Novartis: Our strategy Our focus Our priorities > Conclusion Abbreviations Novartis concluded that separation of Sandoz, via 100% spin-off, is in the best interests of shareholders (completion H2 2023) Expected benefits U NOVARTIS (New-Novartis) Clear investment thesis as an Innovative Medicines business ■ Exclusive focus and investment in Innovative Medicines Strong position in 5 core TAs, leadership in technology platforms ■ Enhanced execution of the pipeline and commercialization Improved financial profile and return on capital Organizational and operational simplification Capital allocation based on its business needs SANDOZ (Standalone) Clear investment thesis as a Generics and Biosimilars business #1 European Generics company1 and a global leader in Biosimilars ■ More effective business strategy for the Gx market Greater freedom to operate Capital allocation based on its business needs ■ Culture fit for the Gx industry, with focus on faster/leaner decision-making and more efficient use of cost base Improving access with broad patient reach of ~500m patients Limited synergies between Innovative Medicines and Generics; at opposite ends of the biopharma value chain with significant differences in business dynamics 1. Based on IQVIA MAT 03/2022, gross sales for combined Generics and Biosimilars market. 31 Novartis Investor Presentation | September 22, 2022 U | NOVARTIS | Reimagining Medicine#32New Novartis: Our strategy Our focus Our priorities > Conclusion Abbreviations Sandoz is uniquely positioned with a strong and balanced presence in both Generics and Biosimilars Gross sales in global Biosimilars and Generics¹ %, vs. key competitors Illustrative European "pure-play" Generics and Biosimilar market leader H1 sales - total USD 4.7bn (+6%)¹ Accelerating leadership in Europe Healthcare peers with Biosimilars sales % CC D C Sales percentage in sales¹ Global Biosimilars <30% Generics peers A E LLI B H LL F Sandoz Europe USD 2.5bn (+7%) <30% Double-digit growth Row ROW USD 1.3bn (+11%) US USD 0.9bn (-2%) Stabilizing in US Sales percentage in Global Gx sales¹ Substantial synergies between Gx and Biosimilars: commercial execution, channels, people and culture 1. Reported H1'22 Earnings 32 Novartis Investor Presentation | September 22, 2022 U | NOVARTIS | Reimagining Medicine#33New Novartis: Our strategy Our focus Our priorities > Conclusion Abbreviations Key takeaways 1 Transforming to a pure-play IM company 2 Focusing strategy on 5 core TAs, technology platforms and the US 3 Establishing 8 in-market brands with multi-bn $ potential 4 Prioritizing pipeline to high-value NMES in our 5 core TAS 5 Continuing to deliver improved financials 33 Novartis Investor Presentation | September 22, 2022 6 Continuing with shareholder friendly capital allocation 7 Strengthening foundations – ESG and culture 1 | NOVARTIS | Reimagining Medicine#34New Novartis: Our strategy Our focus Our priorities Abbreviations Conclusion 1L 2/3L First-line IM Innovative Medicines Second or third line LDLC adj.BC Adjuvant breast cancer LMICS Low-density lipoprotein cholesterol Low/middle income countries > Abbreviations aHUS atypical Hemolytic Uremic Syndrome LN Lupus nephritis ALS Amyotrophic lateral sclerosis LP Lichen Planus AML Acute myeloid leukemia Lp(a) AMR axSPA Axial spondyloarthritis BAFF BCR BTK C3G Antimicrobial resistance B-cell activating factor Biochemical recurrence Bruton tyrosine kinase C3 glomerulopathy MBC mCRPC MDS MDT MHSPC MS CML Chronic myeloid leukemia NME CVRR Cardio-vascular risk reduction NSCLC Secondary prevention of cardiovascular events in CVRR-LDLC OA patients with elevated levels of LDLC PCa CVRR-Lp(a) Secondary prevention of cardiovascular events in PDAC patients with elevated levels of lipoprotein (a) PDL-1 ECN EMB Executive committee of Novartis Emerging Market Brands Programmed death-ligand 1 PNH ES-SCLC Extensive stage small cell lung cancer PPGL FA Food allergy PSA IV PSMA GBM Glioblastoma GCA Giant cell arteritis RLI GEA Gastroesophageal adenocarcinoma RLT GEP-NET Gastroenteropancreatic neuroendocrine tumor Sjs GIST Gastrointestinal stromal tumor SMA-IT GRPR Gastrin-releasing peptide receptor SSA Gx Generics TA HA Health authorities TKI iDFS Invasive Disease-Free Survival TPD IgAN IgA nephropathy TPP Lipoprotein(a) Metastatic breast cancer Metastatic castration-resistant prostate cancer Myelodysplastic syndrome Multi Disciplinary Team Metastatic hormone-sensitive prostate cancer Multiple sclerosis New molecular entity Non-small cell lung cancer Osteoarthritis Prostate cancer Pancreatic ductal adenocarcinoma Paroxysmal nocturnal haemoglobinuria Pheochromocytoma and paragangliomas Psoriatic arthritis Intravenous Prostate-specific membrane antigen Radioligand imaging Radioligand therapy Sjögren's syndrome Spinal muscular atropy-intrathecal SubSaharan Africa Strategy Therapeutic area Tyrosine kinase inhibitor Target product profile 34 Novartis Investor Presentation | September 22, 2022 Targeted protein degradation 1 U | 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