Q3 2014 Results Investor presentation October 28, 2014 Disclaimer This presentation contains forward-looking statements that can be identified by words such as “potential,” “expected,” “will,” “planned,” or similar terms, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; potential shareholder returns or credit rating; or regarding the potential completion of the announced transactions with GSK and Lilly, the potential completion of the announced transaction regarding the Novartis influenza vaccines franchise, or regarding potential future sales or earnings of any of the businesses involved in the announced transactions, or of the Novartis Group, and regarding any potential strategic benefits, synergies or opportunities as a result of the announced transactions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. 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 forwardlooking statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee that the announced transactions will be completed in the expected form or within the expected time frame or at all. Neither can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the transactions. Neither can there be any guarantee that Novartis or any of the businesses involved in the transactions will achieve any particular financial results in the future. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including an unexpected failure to obtain necessary government approvals for the transactions, or unexpected delays in obtaining such approvals; the potential that the strategic benefits, synergies or opportunities expected from the transactions may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the Company’s ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on the Company of the loss of patent protection and exclusivity on key products which commenced in prior years and will continue this year; unexpected manufacturing or quality issues; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, government investigations and intellectual property disputes; general economic and industry conditions; uncertainties regarding the effects of the persistently weak global economic and financial environment; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare 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. 2 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Agenda 3 Group overview Joseph Jimenez Chief Executive Officer Financial review Harry Kirsch Chief Financial Officer Pharmaceuticals David Epstein Division Head, Novartis Pharmaceuticals Closing Joseph Jimenez Chief Executive Officer Q&A session Executive team | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation We delivered solid sales performance, strong margin expansion and significant innovation in Q3 Reinforcing strong innovation momentum in Q3, including: • LCZ696 positive phase III data in chronic heart failure • AIN457 positive FDA Advisory Committee recommendation in psoriasis Sales growth at +5% in cc vs. PY1 Core Operating margin improvement of 1.5% pts in Q31 (in cc) 1 4 Group growth rates are based on 2013 data excluding the divestment blood transfusion diagnostics unit. See page 81 of the Condensed Interim Financial Report | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Strong financials results in Q3 Q3 (in USD m) 2014 Net Sales Change vs. PY 2 1 % USD % cc 14 704 4 5 Core Operating Income 3 840 8 11 Operating Income 2 980 14 18 Net Income 3 240 45 49 Core EPS (USD) 1.37 10 13 EPS (USD) 1.33 48 51 3 165 -9 Free Cash Flow 1 2 3 5 3 3 Group growth rates are based on 2013 data excluding the divested blood transfusion diagnostics unit. See page 81 of the Condensed Interim Financial Report. This measure, as well as constant currencies (cc), core results, and free cash flow are non-IFRS measures. An explanation of these non-IFRS measures and reconciliation tables can be found beginning on page 52 of the Condensed Interim Financial Report 2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date. See page 21 of the Condensed Interim Financial Report for more information Includes the USD 0.8 billion pre-tax gain from the sale of shares of Idenix Pharmaceuticals | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation We progressed our strategic priorities Innovation LCZ696 phase III positive data in chronic heart failure AIN457 positive FDA Advisory Committee recommendation in psoriasis Growth Growth products 33% of Productivity Core operating margin Group sales in Q3 Emerging Growth Markets grow +13% in Q3 vs. PY in cc1 Clinical collaboration to evaluate BMS’ novel immunotherapy in combination treatments for NSCLC 1 6 Group growth rates are based on 2013 data excluding the divested blood transfusion diagnostics unit. See page 81 of the Condensed Interim Financial Report | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation improved 1.5% pts in Q3 (in cc1), mainly due to R&D and M&S Innovation We achieved important product milestones for critical disease areas Key regulatory news in Q3 2014 Filgrastim biosimilar AIN457 Positive CHMP opinion in EU 7 Positive FDA Advisory Committee in psoriasis | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Approval in EU Submitted to FDA Innovation We advanced our pipeline significantly, reinforcing key franchise leadership Key Q3 clinical results LCZ696 AIN457 LDE225 Positive Phase III data in chronic heart failure1 Positive phase IIIs in psoriatic arthritis and in ankylosing spondylitis Regulatory application submitted to FDA in advanced basal cell carcinoma 1 8 With reduced ejection fraction | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Innovation We have acquired WaveTec to further strengthen Alcon’s innovation leadership in cataract refractive surgery Acquired Intra-operative surgical guidance helps improve patient outcomes First commercialized intraoperative aberrometry system in the US ORA 9 System® | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Acquisition complements Alcon’s industry-leading cataract refractive suite Growth Growth across all divisions, with profit leverage in all divisions % Change vs. PY1 Net sales Q3 2014 (in USD m) 7 925 Pharmaceuticals 2 665 Alcon 2 401 Sandoz Consumer Health Vaccines 1 (in cc) 1 125 588 Net sales Core Operating Income +1% +5% +6% +12% +7% +14% +9% +74% +31% nm Vaccines growth rates are based on 2013 data excluding the divested blood transfusion diagnostics unit. Vaccines result exclude certain intellectual property rights and related other revenues which will be retained by Novartis and are now reported under Corporate activities, with 2013 reported results being restated for this impact. See page 81 of the Condensed Interim Financial Report 10 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Growth Our growth products and Emerging Growth Markets remain engines of our performance across divisions Growth products transforming our portfolio 33% of sales 1 Driving growth in emerging markets 1 +13% Emerging Growth Markets Q3 vs. PY (% cc). Group growth rates based on 2013 data excluding the divested blood transfusion diagnostics unit. See page 81 of the Condensed Interim Financial Report 11 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Growth - Pharmaceuticals Our Pharmaceuticals growth products maintained strong momentum in Q3 2014 Net sales1 (in USD m) +27% 653 Q3 2013 Q3 2014 +7% 614 +22% 408 +25% 391 -5%2 293 +39% +90% 207 123 3 1 2 3 All growth rates vs. PY are in constant currencies Impacted by Galvus in Germany, where distribution was stopped July 1, 2014. Excluding Germany, Q3 growth vs. PY is +8% Onbrez® Breezhaler® approved as Arcapta® Neohaler® in the US 12 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation +43% 69 Growth – Alcon Alcon grew +6% in Q3, driven by Surgical Alcon Net Sales1 (in USD m) Highlights +6% 2 665 Surgical (+10%): Strong Centurion® and LenSx® performance, with IOL returning to growth 2 539 Ophthalmic Pharmaceuticals (+4%): Double-digit Systane®, Ilevro®, and Azarga® growth Q3 2013 1 Q3 2014 All growth rates are vs. PY, in constant currencies 13 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Vision Care (+4%): Strong continued Dailies Total1® launch Growth – Sandoz Strong Sandoz performance, with +7% sales growth vs. PY in cc and core margin expansion Sandoz Net Sales1 (in USD m) +7% 2 401 Strong Sandoz Q3 performance, mainly driven by: US including launch of AGx Diovan® 2 273 monotherapy Biosimilars and oncology injectables Key Emerging Markets Q3 2013 1 Q3 2014 All growth rates are vs. PY, in constant currencies 14 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Productivity Our productivity initiatives contribute to growth of core operating leverage Group core operating margin1 (vs. PY in ppts cc) +1.5% pts +1.2% pts Q3 2014 1 9M 2014 Group growth rates are based on 2013 data excluding the divested blood transfusion diagnostics unit. See page 81 of the Condensed Interim Financial Report 15 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation We have just announced the agreement to divest our influenza business Binding agreement to divest influenza vaccines business to Australia-based CSL™ USD 275 m in cash Expected to close in H2 2015 16 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation The transformation of Novartis is progressing on track 2014 milestones 8 January Closed divestiture of blood diagnostics business 17 22 April Announced agreement to: Acquire GSK oncology products Create Consumer Health JV with GSK Divest Novartis Vaccines (excl. influenza) Divest Novartis Animal Health | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation 1 July 26 October Established Novartis Business Services Announced agreement to divest influenza business Novartis Business Services is now providing services across divisions Information Technology 1 Procurement Human Resources Services Includes Commercial and Medical Affairs Services 18 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Real Estate & Facility Services Financial Reporting & Accounting Operations Global Business Services1 Agenda Group overview Joseph Jimenez Chief Executive Officer Financial review Harry Kirsch Chief Financial Officer Pharmaceuticals David Epstein Division Head, Novartis Pharmaceuticals Closing Joseph Jimenez Chief Executive Officer Q&A session Executive team 19 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Strong margin expansion in Q3 and nine months Change vs. PY Q3 (in USD m) 2014 Net Sales % USD % cc 14 704 4 5 Core Operating Income 3 840 8 Operating Income 2 980 Net Income 2 3 4 Change vs. PY 9M 2 % cc 43 363 2 3 11 11 294 4 8 14 18 9 564 14 20 3 240 45 49 8 793 23 28 Core EPS (USD) 1.37 10 13 4.02 5 9 EPS (USD) 1.33 48 51 3.58 24 29 3 165 -9 6 343 -2 4 4 2014 1 % USD Free Cash Flow 1 2 1 3 3, 4 3, 4 All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. See page 81 of the Condensed Interim Financial Report 2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date. See page 21 of the Condensed Interim Financial Report for more information Includes the USD 0.9 billion pre-tax gain from the divestment of the blood transfusion diagnostics unit Includes the USD 0.8 billion pre-tax gain from the sale of shares of Idenix Pharmaceuticals 20 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Strong volume growth more than offsets generic impact in Q3 Group Q3 2014 (in % growth vs. PY1) Net sales Core operating income Underlying volume Price Underlying growth2 Generics impact3 2 3 0 0 10 25 -14 11 5 Currency 1 25 -5 CC growth USD growth 10 -1 4 -3 8 All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. See page 81 of the Condensed Interim Financial Report Underlying growth is the growth rate excluding the impact of generic competition and is calculated by adding back sales and core operating income resulting from generic impact to the reported figures Generics impact on sales amounted to USD 0.6 billion in the quarter 21 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Growth products continued to increase their contribution to overall portfolio Q3 ’14 vs. Q3 ’13 % of sales Group Pharmaceuticals (in USD bn) (in USD bn) 28% 33% 38% 44% 4.9 4.0 3.0 Q3 2013 22 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Q3 2014 Q3 2013 3.5 Q3 2014 All divisions contributed to Q3 Group core margin improvement of 1.5% points Q3 2014 vs. PY1 Net sales (in % cc) Core operating income (in % cc) Pharmaceuticals 1 5 30.3 1.1 Alcon 6 12 36.0 1.9 Sandoz 7 14 17.4 1.1 Consumer Health 9 74 16.0 6.33 31 nm 12.1 8.23 5 11 26.1 1.53 Vaccines2 Group 1 2 3 Core ROS (%) Core margin change in cc (% pts) All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. See page 81 of the Condensed Interim Financial Report Vaccines results exclude certain intellectual property rights & related other revenues which will be retained by Novartis and now reported under Corporate activities, with 2013 reported results being restated for this impact Includes cessation of depreciation since portfolio transformation announcement date of +1.3% pts for Consumer Health, +6.3% pts for Vaccines, and +0.3% pts for total Group 23 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Q3 Group core margin improvement mainly from R&D and M&S Group core R&D Group core M&S as % sales (USD) as % sales (USD) -1.1% pts (cc) -1.3% pts (cc) -0.9% pts (USD) -1.4% pts (USD) 24.5% 24 16.6% 15.7% Q3 2013 Q3 2014 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Q3 2013 23.1% Q3 2014 Increasing currency impact on sales in Q3 from weaker Yen and emerging market currencies Currency impact vs. PY (in % points) Net sales Core operating income 0 -2 -2 -2 -2 -1 -2 -2 -3 -4 -6 -3 -3 Q2 Q3 -6 -4 to -5-5 -8 Q1 Q2 Q3 2013 Q4 Q1 Q2 Q3 FY1 Q1 2014 FY impact: -2% 1 Expected full year currency impact assuming early October average exchange rates prevail for the remainder of the year 25 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Q2 Q3 2013 FY impact: -5% Q4 Q1 2014 FY1 Free Cash Flow in line with prior year 9M Free Cash Flow (in USD bn) Key drivers of free cash flow 1 -0.2 6.5 6.3 Higher operating income Offset by: Currency impact Higher net working capital Investments in intangibles 9M 2013 1 9M 2014 All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. See page 81 of the Condensed Interim Financial Report 26 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation As of September 30, net debt increased by USD 0.4 billion to USD 9.2 billion (in USD bn) -0.4 6.3 2.4 -6.8 -5.0 2.3 0.4 -8.8 December 2013 1 2 3 Free Cash Flow Dividends Net divestment 1 proceeds Proceeds from Share repurchases 2 options exercised 3 Others Mainly due to divestment of the Vaccines blood transfusion diagnostics unit net of tax (USD 1.2 bn) and sale of shares of Idenix Pharmaceuticals (pre-tax gain of USD 0.8 billion) Related to employee participation programs Including mainly repurchases on the first (USD 2.9 bn) and second trading lines (USD 1.7 bn) 27 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation -9.2 September 2014 Impact of the binding sale agreement1 to divest influenza vaccines business to CSL™ With the signing of the binding sale agreement1 for the influenza vaccines business to CSL™ for USD 275 million, the vaccines business is now divested to two separate buyers As a result, IFRS requires a separate valuation of the influenza vaccines net assets This triggers the recognition of an exceptional pre-tax, non-cash impairment charge of approximately USD 1.1 billion Upon closing the deal with GSK for the remaining non-influenza vaccines business, Novartis expects to record a substantial non-cash gain, which will more than compensate for this previously recognized non-cash impairment charge1 Novartis expects to record significant additional gains upon closing of the other inter-conditional transactions with GSK and the transaction with Lilly announced on April 221 1 The transactions are subject to customary closing conditions including regulatory approvals; GSK transactions are also inter-conditional and subject to approval by its shareholders 28 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Full year outlook1 confirmed Barring unforeseen events Group net sales in 2014 are expected to grow at a low to mid-single digit rate (cc) Group core operating income is expected to grow ahead of sales (cc) in 2014, at mid to high-single digit (cc) 1 The outlook is based on the total Group business. This includes the cessation of depreciation and amortization following IFRS reporting requirements, although this is not expected to have a material impact on guidance. All comparisons to prior year are based on 2013 data excluding the divested blood transfusion diagnostics unit for 2013 29 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Agenda Group overview Joseph Jimenez Chief Executive Officer Financial review Harry Kirsch Chief Financial Officer Pharmaceuticals David Epstein Division Head, Novartis Pharmaceuticals Closing Joseph Jimenez Chief Executive Officer Q&A session Executive team 30 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Pharmaceuticals sales +1% in cc in Q3 2014 with core operating income leverage Change vs. PY (in USD m) (% USD) (% cc) Q3 2014 Q3 2013 Net Sales 7 925 7 893 0 +1 Core Operating Income 2 405 2 345 +3 +5 Operating Income 2 233 2 267 -1 +1 Core Operating Income margin 30.3% 29.7% Operating Income margin 28.2% 28.7% 2 376 2 510 Free Cash Flow 31 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation -5 Portfolio rejuvenation progressing well; growth products1 now represent 44% of total division sales Growth products sales (in USD bn) +16% cc 3.5 3.0 Q3 2013 Q3 2014 % of total sales 38% 1 44% Growth products comprise products launched in 2009 or later, or products with exclusivity until at least 2018 in key markets (EU, US, Japan) 32 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Emerging markets growth in Q3 was robust driven by Brazil, China and Turkey Growth Q3 2014 vs. PY (in % cc) Net sales Q3 Growth rates Q3 in selected emerging markets 24% Emerging Growth Markets 13% USD 2 056 m 22% 14% Established Markets 33 -2% | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation USD 5 869 m Unparalleled growth platform1 with exclusivity until 2018 and beyond Q3 2014 Sales (USD m) Indication Multiple sclerosis 653 27% 614 7% 408 22% Chronic myeloid leukemia 391 25% Diabetes mellitus, Type 2 293 -5% 2 Moderate to severe asthma and chronic spontaneous 207 39% Wet age-related macular degeneration, Diabetic macular edema, Retinal vein occlusion, mCNV Metastatic renal cell carcinoma, TSC SEGA, pNET, HR+/HER2-advanced breast cancer urticaria 3 Chronic obstructive pulmonary disease 123 Myelofibrosis 1 2 Key products for Pharmaceuticals growth Impacted by Galvus in Germany, where distribution was stopped July 1, 2014. Excluding Germany, Q3 growth vs. PY is +8% 34 Q3 2014 Growth vs. PY (% cc) | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation 69 3 4 4 90% 43% Onbrez® Breezhaler® approved as Arcapta® Neohaler® in the US Net sales and growth of Onbrez®, Seebri® and Ultibro® 4 Gilenya® growing strongly despite increasing competition Gilenya® sales and growth (in USD m, growth in % cc) US Ex-US US: Double-digit volume growth vs. PY. Switches +37% +18% 332 321 273 245 from other disease modifying therapies to Gilenya® continue to grow1 Ex-US: Gilenya® #1 in H1 2014 sales2 New data presented at A/ECTRIMS confirmed high efficacy of Gilenya® in achieving “no evidence of disease activity (NEDA)” based on four key measures of MS3 Topline PPMS results expected in Q4 2014 Q3 2013 1 2 3 Q3 2014 Q2 and Q3 2014 IMS NPA Market Dynamics (Tysabri not reported) Leading share (18.4%) of combined global Multiple Sclerosis segment except that of the USA. Source: Evaluate Pharma Patients taking Gilenya® had a more than four-times greater likelihood of achieving NEDA across four key measures of Multiple Sclerosis (relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression) vs. placebo, odds ratio 4.41; 95% CI 3.03-6.42; p<0.0001 35 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Lucentis® launches in new indications continue to drive growth Lucentis® ex-US1 sales2 and growth (in USD m, growth in % cc) Lucentis® achieved strong single digit volume +7% growth 581 614 27% Lucentis® pre-filled syringe successfully 42% launched in Belgium, Denmark, Spain, Netherlands and Australia in Q3 EMA label update approved in EU allowing for 73% Q3 2013 Wet AMD 1 2 58% DME Q3 2014 RVO mCNV Genentech has rights to Lucentis® in the US Sales indication split based on market research and Novartis estimates 36 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation flexible and individualized treatment regimen including treat and extend Afinitor® - multiple sources of growth Afinitor® global sales (in USD m) 500 337 7% 8% 10% 10% 25% 54% 100 48% Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 2012 2014 2009 2010 2011 2013 Sales indication split based on market research and Novartis estimates Indeterminate usage 37 -47% 3% +73% +18% +8% 29% 200 2 408 7% 6% 300 1 +22% Launch in Breast Cancer 400 0 Afinitor® - Q3 sales split per indication1 (in USD m, growth in % cc) | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Q3 2013 Q3 2014 +36% Other 2 TSC / SEGA pNET RCC BC Tasigna® continues to deliver double digit growth 7 years post launch Tasigna® sales and growth (in USD m, growth in % cc) US Ex-US +25% 250 204 +27% US sales driven by share gains in Ph+ newly diagnosed CML patients and from patients resistant / intolerant to imatinib Ex-US growth driven by continued uptake in 141 Emerging Growth Markets 111 Received CHMP positive opinion on the ENESTnd 5year long-term follow-up label update in Q3 2014 Q3 2013 38 Q3 2014 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Myelofibrosis driving strong performance for Jakavi® Jakavi® sales and growth (in USD m, growth in % cc) +65% 195 Recent approval and reimbursement received in Japan for Myelofibrosis indication EMA label updated in July to include long-term survival follow up 116 Submissions ongoing following positive pivotal study results in Polycythemia Vera • Submitted in US in Q2, in Japan and EU in Q3 9M 2013 39 9M 2014 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Ultibro® Breezhaler® expanding the evidence into exacerbation benefit vs. Seretide® The LANTERN Trial1 Moderate to severe exacerbations (annualized rate) Analysis of the rate of exacerbations2 2 3 Ultibro® Breezhaler® significantly reduced the rate of moderate to severe exacerbations by 31% beyond Seretide®2,3 0.4 0.3 Both primary and key secondary objectives were 0.2 Positive results were part of the regulatory 0.1 0 1 Rate ratio 0.69 0.5 met in pivotal Phase III LANTERN study submission in China 0.45 0.31 Seretide® 50/500 μg BID Ultibro® 27.5/12.5 μg BID USD 31 m sales in Q3 Zhong N. et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone combination (SFC) in patients with COPD: the LANTERN study. [ERS abstract 700090; Session 281, Poster P2815¨] The primary objective of the study was to demonstrate the non-inferiority of Ultibro® Breezhaler® 110/50 mcg to SFC 50/500 mcg in terms of lung function (trough FEV1) after 26 weeks of treatment in stable patients with moderate-to-severe COPD, with a history of one exacerbation or none in the previous year. Ultibro® Breezhaler® demonstrated non-inferiority and additionally showed superior efficacy versus SFC for the primary objective. In this study, exacerbations were a pre-specified exploratory endpoint Seretide® (salmeterol/fluticasone) 50/500 mcg was used via the Accuhaler® dry powder inhaler. Seretide® is also known as Advair® and Accuhaler® is also known as Diskus®. Seretide®, Advair®, Diskus® and Accuhaler® are registered trademarks of the GlaxoSmithKline group of companies 40 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Zykadia™ durable responses, better than expected Data presented at ESMO: PFS1 for ALK+ patients treated with ceritinib in ASCEND-12 Zykadia™ demonstrated a high rate of durable 100 Probability (%) 80 60 40 20 0 0 1 2 3 4 3 6 Progression Free Survival Felip E. et al. Poster. ESMO 2014 Duration of Response Shaw AT et al. Poster. ESMO 2014 41 9 responses in ALK+ non-small cell lung cancer naive patients: • Median PFS1: 18.4 months2 • Median DOR3: 17.02 months2 Documented systemic benefit and intracranial activity in patients with brain metastases4 Strong US launch trajectory, Q3 revenue (USD 12 m) grew 74% vs. Q2. Regulatory reviews underway in the EU and other 12 15 18 21 24 27 30 33 36 countries worldwide Time (Months) We announced a collaboration to evaluate BMS’ novel immunotherapy in combination treatments for NSCLC | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation LCZ696 - building momentum; positive preliminary regulatory discussions PARAGON-HF trial started enrolling in the HFpEF population July 2014 1 2 PARADIGM-HF data presented at ESC1, LCZ696: reduced the risk of death from cardiovascular causes by incremental 20% reduced first heart failure hospitalizations by incremental 21% August 2014 European Society of Cardiology American Heart Association 42 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Disease progression data from PARADIGM-HF to be presented at AHA2 Quality of life Impact on recurrent hospitalizations and resource utilization Cause of death November 2014 Expected completion of submission in US Year-end 2014 Expected submission in EU / RoW Early 2015 AIN457 (secukinumab) with potential to be the first anti-IL-17 to enter both the dermatology and rheumatology spaces Psoriatic Arthritis (PsA) A debilitating, long-lasting condition that causes inflammation of joints and skin and affects up to 30% of people with psoriasis globally FDA Advisory Committee unanimously recommended approval for AIN457 in psoriasis AIN457 met all primary and key secondary endpoints in Phase III studies for both PsA and AS AIN457 PsA and AS Phase III data to be presented at ACR1 2014 Ankylosing Spondylitis (AS) A painful, progressively debilitating condition associated with inflammation of the spine, causing irreversible consequences that significantly reduce patients' mobility and quality of life 1 2 Only 20% biologics used amongst eligible PsA and AS patients2 Regulatory submissions are planned for both PsA and AS in H1 2015 American College of Rheumatology Source: Gelfand, 2005 (PsA prevalence), Reveille JD et al. 2013 (AS prevalence), Decision Resources 2013 (PsA treated pool) and Datamonitor 2008 (AS treated pool) reports. Patients on Biologics calculated from sales units data; IMS PADDS Quarterly sales & yearly Medical Data 43 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Currently expected Pharmaceuticals newsflow highlights H1 2014 H2 2014 1 Afinitor® Japan action in HR+ Breast cancer Lucentis® Japan action in Diabetic Macular Edema Lucentis® Japan approval of pre-filled syringe RLX030 FDA issued complete response letter in May RLX030 CHMP negative opinion in May Xolair® CHMP opinion in Chronic Spontaneous Urticaria Xolair® FDA action in Chronic Idiopathic Urticaria Zykadia™ FDA action in NSCLC AIN457 FDA Advisory Committee for Psoriasis expected in Oct. 2014 (FDA Action expected in Jan. 2015) AIN457 CHMP opinion in Psoriasis Jakavi® Japan action in Myelofibrosis LCZ696 Phase III data presentation at Signifor® LAR FDA action in Acromegaly Signifor® LAR CHMP opinion in Acromegaly European Society of Cardiology 44 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation ESC1 2014 Agenda Group overview Joseph Jimenez Chief Executive Officer Financial review Harry Kirsch Chief Financial Officer Pharmaceuticals David Epstein Division Head, Novartis Pharmaceuticals Closing Joseph Jimenez Chief Executive Officer Q&A session Executive team 45 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation We are delivering against our priorities Strong Q3 financial results Strong Innovation news adding to momentum Progress on portfolio transformation and NBS 46 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation Appendix Planned filings 2014 to 2018 2014 2015 2016 2017 LBH589 * BKM120 BYM338 DEB025 Multiple Myeloma mBC ER+ AI resistant/mTOR naive LCQ908 PKC412 FCS1 LCZ696 Heart failure (REF)2 LDE225 ** Fovista® AIN457 Psoriatic arthritis Afinitor® AIN457 HER2+ Breast cancer 1st Line Rheumatoid arthritis Afinitor® Gilenya® Jakavi® **** PKC412 HER2+ Breast cancer 2nd/3rd Line PPMS7 Polycythemia vera Wet AMD LEE011 LCI699 BCT197 Afinitor® COPD18 Solid tumors ACZ885 BGS649 CTL019 DLBCL17 BGJ398 Solid tumors MEK162 OHH19 BYL719 DLBCL17 Solid tumors MEK162 + LGX818 BKM120 Solid tumors BYM338 Hip fracture and Sarcopenia Alzheimer’s disease RLX030 FCR001 Acute Heart Failure Afinitor® TSC10 Seizure Stem cell transplantation HSC835 Lucentis® BKM120 INC280 MEK162 mBC ER+ post Al and mTOR inhibitor Solid tumors Gilenya® LIK066 Type II diabetes CIDP11 Ilaris® LJM716 Hereditary Periodic Fevers Solid tumors Lucentis® QAW039 Asthma LGSOC13 Tasigna® 2 3 4 New indication 5 6 7 New formulation 8 9 10 48 Familial chylomicronemia syndrome Reduced ejection fraction Non-small cell lung cancer Film-coated table Acute myeloid leukemia Neuroendocrine tumors Primary progressive multiple sclerosis Aggressive systemic mastocytosis Sporadic inclusion body myositis Tuberous sclerosis complex CML Treatment free remission Tekturna® 11 12 Heart failure14 Zykadia™ ALK+advanced (first line, treatment naive) | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation LGX818 Solid tumors MEK162 1 LEE011 Solid tumors Renal transplantation CNV and ME12 New molecule LCZ696 Heart failure (PEF)20 CAD106 BRAF Mutant Melanoma Iron overload QGE031 Allergic diseases Sec. Prev. CV events16 ASM8 LBH589 was filed in the US and EU in Q2 2014 LDE225 was filed in EU in Q2 2014, US application submitted in Q3 Zykadia™ (ceritinib) was approved in the US on April 29, 2014 Jakavi ® was filed in the EU in Q2 2014 and submitted in Japan in Q3 Exjade® FCT was submitted in the US in Q2 2014 BAF312 Multiple sclerosis BRAF Mutant Melanoma NRAS Mutant Melanoma Allergic diseases Malaria TKI258 LGX818 QAX576 Solid tumors Cushing’s Disease Breast cancer Exjade® FCT4 ***** * ** *** **** ***** KAE609 Afinitor® AIN457 Zykadia™ *** CTL019 Acute Lymphoblastic Leukemia Ankylosing spondylitis ALK+ advanced NSCLC3 HCV infection AML5 Non-functioning GI and Lung NET6 Advanced Basal Cell Carcinoma sIBM9 2018 AUY922 NSCLC3 Signifor® LAR15 Cushing’s Disease 13 14 Chronic inflammatory demyelinating polyradiculoneuropathy Choroidal neovascularization (CNV) and macular edema (ME) secondary to conditions other than macular degeneration, diabetic macular edema, retinal vein occlusion and pathologic myopia Low-grade serous ovarian cancer Reduction of CV death/hospitalization in chronic heart failure patients 15 16 17 18 19 20 21 Long-acting release Secondary prevention of cardiovascular events Diffuse large B-cell lymphoma Chronic obstructive pulmonary disease Obese hypogonadotropic hypogonadism Preserved ejection fraction Retinopathy of prematurity ROP21 Solid tumors Key Definitions This presentation contains several important words or phrases that we define as below: AGx: Authorized Generic M&S: Marketing and Sales ALK+ NSCLC: Anaplastic lymphoma kinase positive (ALK+) Non-small cell lung cancer (NSCLC) mCNV: Choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV) ALL: Relapsed/refractory B-cell acute lymphoblastic leukemia NEJM: New England Journal of Medicines Approval: In Pharmaceuticals, Alcon and Vaccines in US and EU; each indication and regulator combination counts as approval; excludes label updates, CHMP opinions alone, and minor approvals NSCLC: Non Small Cell Lung Cancer BC: Breast Cancer CART: Chimeric Antigen Receptor T-cell CHF: Chronic Heart Failure CML: Chronic myelogenous leukemia DME: Diabetic Macular Edema Emerging Growth Markets: All markets excluding the US, Canada, Western Europe, Japan, Australia, and New Zealand Growth products: Growth products comprise products launched in 2009 or later, or products with exclusivity until at least 2018 in key markets (EU, US, Japan) (except Sandoz, which includes only products launched in the last 24 months) HFpEF: Heart Failure with preserved Ejection Fraction HFrEF: Heart Failure with reduced Ejection Fraction HR+/HER2-: Hormone Receptor positive, Human Epidermal Growth Factor 2 negative In cc: In constant currencies 49 | Novartis Q3 2014 Results | October 28, 2014 | Novartis Investor Presentation PDGF: Platelet Derived Growth Factor Ph+: Philadelphia chromosome positive; pNET: Pancreatic neuroendocrine tumors PPMS: Primary Progressive Multiple Sclerosis RCC: Renal Cell Carcinoma R&D: Research and Development RVO: Retinal Vein Occlusion TSC SEGA: Tuberous sclerosis complex subependymal giant cell astrocytoma wAMD: wet age-related macular degeneration
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