Novartis AG · SIX:NOVN
Novartis — FRESCO 2004 Analyst Meeting
28 slides from Novartis's conference presentation, Jan 20, 2005
Slide 1: Novartis Oncology and Specialty Medicines
Novartis Oncology and Specialty Medicines David R. Epstein President, Novartis Oncology CEO, Novartis Specialty Medicines Oncology – Strong Growth and a Leading Position Total sales by year USD m • Four strong brands including 2 blockbusters: 4 500 +22% in LC 4 215 - Glivec ® 4 000 - Zometa® 3 500 •
Slide 2: Aromatase Inhibitors Expected to Expand Hormonal Therapy of Breast Cancer
Femara ® 2004 Sales USD 386 m Growth (LC) +62% 3 FRESCO 2004 / David Epstein / 2005-01-20 / Analysts Aromatase Inhibitors Expected to Expand Hormonal Therapy of Breast Cancer Worldwide hormonal breast cancer therapy market 1 % of revenues USD 1.9 bn +13% 10% CAGR USD 1.3 bn Others 40% +31% 90% CAGR
Slide 3: Femara has Unmatched Clinical Data Across Breast Cancer Continuum
Femara ® has Unmatched Clinical Data Across Breast Cancer Continuum Demonstrated superiority vs. standard of care Early Advanced Neo- Extended First Second Adjuvant adjuvant adjuvant line line Publication Data 36% v. 48% 19% 38% 9.4 v. 6.0 24% v. breast reduction decreased risk months TTP1 16% ORR2
Slide 4: Recent Data at SABCS Shows that AIs May Replace Tamoxifen in Adjuvant
Recent Data at SABCS 1 Shows that AIs2 May Replace Tamoxifen in Adjuvant Setting ATAC study update at SABCS 2004 • Anastrozole shown to be better than tamoxifen as 5 year adjuvant therapy in adjuvant setting • However: − No significant advantage in node-positive patients and those pretreated with ch
Slide 5: Even Greater Numbers of Patients Available within Adjuvant Market Segment
Even Greater Numbers of Patients Available within Adjuvant Market Segment Post-menopausal, estrogen receptor +, breast cancer market segment Number of patients, G6 countries, 2004 Total ~1.2 m patients Advanced Adjuvant1 ~880 000 ~200 000 1st and 2nd line + Extended adjuvant ~133 000/year patients p
Slide 6: Femara – Building a Blockbuster
Future Competitive Advantage Through Combination Studies Novartis proprietary Other combination studies combinations Femara® + RAD001 Ongoing trials with • Simultaneously targeting • Herceptin the ER1 and PI3K / AKT2 • Tarceva signaling pathways in breast cancer • Zarnestra Femara® + Zometa® • Preve
Slide 7: Zometa is Driving Patient Growth in the Large Bisphosphonate Market Segment
Zometa® 2004 Sales USD 1 078 m Growth (LC) +17% 13 FRESCO 2004 / David Epstein / 2005-01-20 / Analysts Zometa® is Driving Patient Growth in the Large Bisphosphonate Market Segment Estimated global yearly patients Total patients 700 000 600 000 Other 500 000 bisphosphonates1 400 000 300 000 200 000 Z
Slide 8: Opportunity for Growth and Penetration in Prostate and Lung Cancer
Revenue Now More Balanced Across Tumor Types as Zometa® Penetrates Prostate and Lung Cancer Zometa® use by tumor type in US, 2004 (%) Other 11 Lung 12 Breast 43 Prostate 13 21 Myeloma Source: IntrinsiQ, MAT Nov 2004 15 FRESCO 2004 / David Epstein / 2005-01-20 / Analysts Opportunity for Growth and Pe
Slide 9: Zometa as the Standard in Bisphosphonate Therapy
Discussion at ESMO1 2004 Highlighted Zometa® as the Standard in Bisphosphonate Therapy Comparison of Pamidro- Ibandro- Clodro- major bisphosphonates2 nate nate nate • Compared with placebo in breast cancer • Demonstrated superiority to placebo in breast cancer in all endpoints • Superiority in head
Slide 10: Recent Label Changes for Zometa
Recent Label Changes for Zometa ® • October 2004 – addition of a precaution that osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bisphosphonates − Majority of reported cases associated with dental procedures such as tooth extraction − D
Slide 11: ZO-FAST/Z-FAST Trials – Prevention of Bone Loss
ZO-FAST/Z-FAST Trials – Prevention of Bone Loss Due to Hormonal Therapy Z-FAST study design / primary endpoint R Letrozole + immediate zoledronic acid (“Upfront”) 1 500 patients A every 6 months Adjuvant BC N D Delayed zoledronic acid: • BMD T score O > -2 SD1 • BMD T score = -2 SD or M Letrozole cl
Slide 12: Glivec CML and GIST Remain Growing Opportunities
Glivec® / Gleevec®1 2004 Sales USD 1 634 m Growth (LC) +36% 1 Glivec® is marketed as Gleevec® in the US 23 FRESCO 2004 / David Epstein / 2005-01-20 / Analysts Glivec® CML1 and GIST 2 Remain Growing Opportunities CML GIST Accelerated/ Metastatic/ Chronic blast inoperable Prevalence, ~ 50 000 ~ 7 000
Slide 13: New Data at ASH Reinforced Glivec as Cornerstone Therapy in CML
New Data at ASH Reinforced Glivec® as Cornerstone Therapy in CML Glivec ® insight Data highlights • Median survival for accelerated phase MD Anderson study patients (Cortes, abstract #1006) demonstrated survival − Pre-Glivec® era: 21 months, advantage in accelerated phase patients versus − Glivec® c
Slide 14: Further Building Our BCR-ABL Franchise
New Data at ASH Reinforced Glivec® as Cornerstone Therapy in CML Glivec ® insight Data highlights • MD Anderson study (Cortes, abstract #0999)1: Glivec® potentially even more effective at higher − 96% achieved complete cytogenetic response doses (e.g., 800 mg) − 67% achieved a major molecular respon
Slide 15: AMN107 Showed Significant Activity in Most Challenging Settings
AMN107 Showed Significant Activity in Most Challenging Settings (All Patients Glivec® Failures) Patients responding by phase (phase I, n=55) Hematologic response rate Cytogenetic response rate % 70 63% 58% 60 50% 50 Impressive 40 activity demonstrated 30 despite short 20% duration of 20 17% follow-u
Slide 16: AMN107 vs. BMS354825 and Phase II Plan
AMN107 vs. BMS354825 Different Approaches to Treating CML AMN107 BMS354825 Pre-clinical activity against most Yes Yes BCR-ABL mutants Activity against T315I mutation No No Src-inhibition No Yes Selectivity for BCR-ABL High Med • AMN107: the most selective BCR-ABL inhibitor reported to date • We beli
Slide 17: Novartis Continues to Develop Glivec in Other Areas
Novartis Continues to Develop Glivec® in Other Areas Market size Indication Phase (prevalence, ‘000)1 Mono- • GIST adjuvant2 < 10 III therapy Combi- • HR Prostate 100 II nation • Ph+ ALL 4 II • Glioblastoma 25 II multiforme Non- • Idiopathic 200 II Oncology pulmonary fibrosis These additional indica
Slide 18: ICL670 – A Novel Oral Iron Chelator
Case Example of Partial Response in GBM 57 year old male with recurrent GBM Pre-treatment • Initiate phase II/III randomized study by end 2005 • Expect to file in 2008 1 month treatment with Glivec® and 5-Hydroxyurea Source: Dr. Reardon, oral presentation, SNO 2004 35 FRESCO 2004 / David Epstein / 2
Slide 19: Iron Overload Affects a Broad Spectrum of Patients
Iron Overload Affects a Broad Spectrum of Patients Myelodysplastic Thalassemia Sickle cell syndrome major disease Prevalence 1 ~150 000 ~10 000 ~90 000 (G7) Est. iron ~45 000 ~10 000 >8 000 overload2 (G7) 1 Population numbers for Thalassemia Intermedia and Minor were not included since most do not r
Slide 20: ICL670 Has Potential to Expand Iron Overload Market Segment
… Current Therapy is Burdensome Desferal® • Slow infusion • 8–12 hours • Currently low 5–7 days/week compliance, high mortality, and no simple, easy to use drug • Many patients forego therapy altogether 39 FRESCO 2004 / David Epstein / 2005-01-20 / Analysts ICL670 Has Potential to Expand Iron Overlo
Slide 21: ICL670 Summary – Changing the Treatment Paradigm in Iron Chelation
Transfusion Rates are Likely to Increase Sickle cell disease example Emerging data Greater access STOP II trial Sickle cell Treatment Act NHLBI Clinical Alert USD 50 m over 5 years recommending Increased creating 40 new rate of continuation of blood treatment centers to transfusions in patients tran
Slide 22: Bright Oncology Outlook
Bright Oncology Outlook • Femara®, Glivec®, Sandostatin® LAR ®, and Zometa® driving near-term growth • Strong 2005 newsflow − BIG 1-98 results in January and mid-year filing − PTK787 colorectal cancer results mid-year − AMN107 enters phase II in Q2 − ZFAST 1 year results at ASCO − ICL670 filing in Q
Slide 23: Appendix
Appendix 45 FRESCO 2004 / David Epstein / 2005-01-20 / Analysts Contents • Ophthalmics • Transplant 46 FRESCO 2004 / David Epstein / 2005-01-20 / Analysts 23
Slide 24: Strong Ophthalmics Growth in 2004
Strong Ophthalmics Growth in 2004 Total sales by year USD m 800 775 750 +19% in LC • Performance driven by 700 strong Visudyne® growth 650 619 − Expanded 600 reimbursement in US 550 − First sales in Japan 500 450 − Continued penetration 400 in other key markets 350 300 2003 2004 47 FRESCO 2004 / Dav
Slide 25: Visudyne – A Cornerstone of AMD Treatment
Visudyne ® – A Cornerstone of AMD 1 Treatment The leading therapy to stop the progression of CNV2 and integral to wet AMD management • Sustained efficacy in predominantly classic AMD • The only treatment with proven long-term (5-year) safety in >1 million treatments • Defined, finite course of thera
Slide 26: Broadening Novartis Presence in Ophthalmics
Broadening Novartis Presence in Ophthalmics • Elidel® in phase II for dry eye and • Lucentis™1 in blepharitis Phase III for wet AMD • Market potential • Submission >USD 1.5 bn (EU) expected by 2014 in Q2 2006 • Market potential >USD 2 bn • Sandostatin® LAR® in phase III for by 2014 diabetic retinopa
Slide 27: Transplantation Stable and Continued Strong Position
Transplantation Stable and Continued Strong Position Total sales and growth (in LC) by year USD m • Neoral®/Sandimmun® - 11% in LC - 5% performing well in LC (-6.8% vs. 2003) 1 200 1 104 1 081 1 092 • Simulect® – recent NICE 1 000 recommendation as preferred option for 800 induction therapy 600 • my
Slide 28: Certican Launch and Future Opportunities in Transplantation
Certican® Launch – Encouraging Early Uptake Certican ® uptake Market segment share, mTOR market segment 1 • Now approved in 25 EU member states for kidney 25% and heart transplantation 20% • Early launch experiences encouraging 15% • Simultaneous availability 10% of the Immunoassay critical to optim