2014/01 - JP Morgan HC


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2014/01 - JP Morgan HC

  1. 1. JP Morgan Healthcare Conference Christopher A. Viehbacher, Chief Executive Officer San Francisco, January 14, 2014
  2. 2. Forward Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding, as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 2
  3. 3. The Opportunity with Sanofi Sanofi has transformed into a company positioned for sustainable growth through its Growth Platforms(1) and has a robust late-stage pipeline of new biologics (1) Growth Platforms include Emerging Markets, Diabetes Solutions, Vaccines, Consumer Healthcare, Animal Health, Genzyme & Other Innovative Products. In Q3 2013, sales from Growth Platforms accounted for 74.7% of Group sales 3
  4. 4. Focusing on Growth Platforms and New Products 1 Emerging Markets 2 Diabetes Solutions 3 Vaccines 4 Consumer Healthcare 5 Genzyme 6 Animal Health 7 Other Innovative Products 4
  5. 5. Sanofi Is Poised to Capture Growth in Fast Growing Markets Sanofi’s Scorecard in Emerging Markets Number one company in Emerging Markets by market share A top position in most of the fast growing economies #1 #1 with 5.7% market share(1) in BRIC and non-BRIC (1) IMS MIDAS MAT Q3 2013 An historical presence and diversified product portfolio One of the biggest sales forces in Emerging Markets A wide network of industrial sites across Emerging Markets ~23,000 37 sales representatives industrial sites A commercial presence in a large number of Emerging Markets 47/53 sales split between Growth platforms and Other products ~100 countries with commercial presence 5
  6. 6. Lantus® Is The Basal Insulin of Reference Worldwide ● Diabetes worldwide prevalence: 382m(1) Quarterly Sales (€m) ● 46% undiagnosed €1,456m ● Almost half live in just three countries (China, India, U.S.) ● Lantus®: prescribers’ first choice for insulin therapy €1,279m €968m ● >10 years of broad clinical experience ● >8m Lantus® patients worldwide ● ORIGIN results on Lantus® CV safety recently integrated into product label ● State-of-the-art, easy-to-use and affordable insulin pens (1) IDF Diabetes Atlas 2013 - 6th Edition 6
  7. 7. U300: Striving to Further Enhance the Value of Current Basal Insulin Flatter PK Profile More Prolonged PD Profile Serum Insulin Glargine Concentration Glucose Infusion Rate 30 5 -1 DOSE 0.4 U.kg U300 U100 -1 U100 0.4 U.kg -1 U300 0.4 U.kg LOESS 0.15 25 4 -1 20 3 -1 GIR - mg.kg .min INSULIN - µU.mL -1 Lantus® 15 U300 10 5 LLOQ 5.02 µU.mL Lantus® 2 1 -1 U300 SC INJECTION 0 0 0 6 12 18 24 30 36 0 6 TIME - hour 12 18 24 30 36 TIME - hour Expected regulatory submission in H1 2014 in U.S. and EU Dahmen R et al, ADA 2013, abstract no. 113-OR. Euglycemic clamp study in T1D in steady state 7
  8. 8. Lyxumia® Is an Add-On Therapy for Patients on Basal Insulin Lyxumia® Easy-to-Use Once-Daily Prandial GLP-1 ● Key benefits of Lyxumia® complementing basal insulin First 2 weeks of therapy Lyxumia® ● Pronounced post-prandial glucose (PPG) lowering effect 10 µg OD SC ● Beneficial effect on body weight ● Limited risk of hypoglycemia ● Indicated in EU for combination use with OADs and basal insulin Remainder of therapy Lyxumia® 20 µg OD SC ● Commercially available in Germany, UK, Spain, Japan and Mexico ● FDA submission expected in 2015 after completion of ELIXA CV outcome trial OD: Once-daily SC: Subcutaneous Lyxumia® is the proprietary name approved by the EMA for lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. In the U.S.; lixisenatide is currently under review by the FDA. Lixisenatide was in-licensed from Zealand Pharma A/S. 8
  9. 9. Combining Insulin Glargine with Lixisenatide in One Single Daily Injection (LixiLan) ● Opportunities in patients not at target on OADs and basal insulin ● Phase II Proof-of-concept study completed(1) ● Phase III expected to start in Q1 2014 ● Potential to be the first combination of Basal Insulin + GLP-1 in one daily injection in the U.S (1) Full data to be submitted for publication in a medical journal + ® 9
  10. 10. Vaccines Have Dealt Effectively with Production Shortfalls to Allow a Return to Growth in 2014 ● Differentiated flu vaccines have invigorated sales ● Hexyon® rolling out in Europe and strong Pentaxim® uptake in Emerging Markets ● Shan 5® WHO prequalification expected in H1 2014 ● Toronto production issues under control and volumes of Pertussis-containing vaccines(1) recovering Differentiated Vaccines Allow for the “Right Dose, Right Patient” Approach (1) Pentacel®, Adacel® and Daptacel® 10
  11. 11. Dengue Vaccine: Addressing a Growing Global Threat Significant Disease Burden(1) ● 2.5bn people at risk ● Estimated 100m dengue infections worldwide per year Ambitious Development Program ● Phase IIb results in ~4,000 children recently published in the Lancet(3) ● Efficacy confirmed against DENV 1, 3 and 4 (in the range of 60% to 90%), and inconclusive against DENV 2 ● 500,000 people with severe dengue requiring hospitalization ● 2.5% of people with severe dengue die ● Dengue is a public health priority in Asia and Latin America ● Dengue is under-reported and thus the burden is likely underestimated(2) ● Safe and well-tolerated ● Global Phase III program ongoing ● Large scale studies in Asia and Latin America ● 31,000 children and adolescents ● Results expected in H2 2014 (1) Dengue and severe dengue; WHO Fact Sheet No. 117 updated Sep. 2013 http://www.who.int/mediacentre/factsheets/fs117/en/index.html (2) Bhatt S et al. Nature. 2013 Apr 25;496(7446):504-7. (3) Sabchareon A et al. Lancet. 2012 Nov 3;380(9853):1559-67. 11 11
  12. 12. C. Diff Toxoid Vaccine: Preventing Primary Symptomatic Clostridium Difficile Infections (CDI) CDI – A Growing Healthcare Problem ● Most common cause of healthcare associated infections in developed countries(2) ● In the U.S. alone, a significant burden(3) ● ~28,000 deaths and up to 450,000 hospital admissions ● Associated cost of care: up to $3.4bn ● Targeted patients at high risk of CDI: ● Elderly with antibiotic use, planned at-risk admissions to hospital and long-term care facilities residents ● Candidate vaccine shown to be safe and immunogenic in Phase I(1) and Phase II trials ● Broad functional antibody responses to both toxins (A and B) ● Cdiffense multinational Phase III trial started in Q3 2013 ● Case driven study ● Up to 15,000 adults to be included ● Fast Track Development Program designation granted by CBER CBER – Center for Biologics Evaluation and Research within FDA (1) Greenberg R, Vaccine, March 2012 (2) He M, Nature Genetics, December 2012, and Miller BA, Control Hosp Epidemiol, April 2011 (3) CDC Morbidity and Mortality Weekly Report, March 2012 12
  13. 13. Sanofi Is the World’s Third Largest CHC Player ● Double digit growth of Top 4 brands ● Allegra®, Doliprane®, Enterogermina® and Essentiale® ● Re-introduction of Rolaids® in the U.S. in Sep 2013 ● Nasacort® Allergy 24HR approved by FDA in Oct 2013 for OTC use ● First and only nasal spray in its class to be available without a prescription ● Creation of a Global Consumer Healthcare Division (1) In 9M 2013. Nicholas Hall & Company Top 10 OTC in Market Share(1) 1. J&J 4.2% 2. BAYER 3.4% 3. 3.1% 4. PFIZER 3.0% 5. NOVARTIS 2.9% 6. GSK 2.6% 7. RECKITT BENCKISER 2.5% 8. BOEHRINGER INGELHEIM 1.5% 9. TAKEDA 1.3% 10. TAISHO 1.3% 13
  14. 14. Genzyme Rare Disease Products Are a Major Growth Driver for Sanofi ● Rebuilding our leadership position in Rare Diseases ● Cerezyme®: #1 therapy for Gaucher disease ● Fabrazyme®: #1 position reached in just four quarters once supply restored 73% value share in 9M 2013(1) for Gaucher disease ● Myozyme®: the only approved therapy for Pompe disease ● Start of clinical development on the next generation ERT for Pompe disease and a small molecule for Fabry disease (1) Based on 9M 2013 reported sales by Sanofi and Shire 52% value share in 9M 2013(1) for Fabry disease 14
  15. 15. Cerdelga™ (eliglustat) - A Novel Investigational Oral Therapy to Expand our Gaucher Franchise ● Oral therapy eliminating infusion challenges ENGAGE - Change in Spleen Volume (% change at 9 months) ● Largest ever clinical program in Gaucher: ~400 adults in 29 countries +2% Eliglustat Placebo ● Phase III studies included patients just starting treatment (ENGAGE) and patients switching from ERT (ENCORE) 30% ● All primary/secondary endpoints met in Phase III studies Absolute  Difference ● Non-inferiority criteria to Cerezyme® met (ENCORE) ● Regulatory review ongoing by EMA and FDA ● Priority review granted in the U.S. p<0.0001 -28% Potential to grow market and build Genzyme share further ERT : Enzyme Replacement Therapy 15
  16. 16. Genzyme’s Commitment and Leadership in Rare Diseases Increases through Expansion of Alnylam Collaboration ● Alnylam’s world-class RNAi technology to provide a platform for sustained drug development for rare genetic diseases for Genzyme ● Focus is on genetically defined diseases with a clear translational model for RNA interference ● Genzyme becomes major Alnylam shareholder through $700 million equity investment Program Rights (subject to opt-in) PC P1 P2 P3 Patisiran (TTR‐FAP) in expanded territory TTRsc (FAC) AT3 (Hemophilia) AS1 (Hepatic Porphyria) Unnamed TTR-FAP: Transthyretin-Familial Amyloïd Polyneuropathy FAC: Familial Amyloïd Cardiomyopathy This transaction has been approved by the boards of both companies, and is subject to customary closing conditions and clearances under the Hart-Scott Rodino Antitrust Improvements Act 16
  17. 17. Global MS Market - Significant and Growing Market Oral and IV Therapies Expected to Grow MS Market Evolution(1,2,3,4) 90% ● Oral share projected to increase four-fold to nearly 40% of the MS market by 2017 driven by new entrants (% market share) therapy(2) ● Intravenous therapies(3) expected to approach 20% of the market ● Injectable therapies(4) (ABCRE’s) projected to decline by roughly half of current usage by 2017 75% 60% Injectables 45% 59% Orals 30% Intravenous 15% 0% 2012 ~€11bn (1) (2) (3) (4) 2017e >€14bn Evaluate Pharma July 2013 Oral category includes Aubagio®, Gilenya®, Tecfidera®, laquinimod, 2nd Gen S1Ps Intravenous category includes Tysabri®, Lemtrada®, ocrelizumab, daclizumab Injectable category includes Avonex®, Betaseron/Betaferon®, Copaxone®, Rebif®, Extavia®, Plegridy™ 17
  18. 18. Genzyme Is Well Positioned to Enter the €11bn Global MS Market with a Franchise Approach Aubagio®: Quarterly Sales €44m ● U.S. sales of €97m in 9M 2013 €33m ● EMA approval granted in Aug 2013(1) €20m ● EU launch rollout started in Q4 2013 ● Strong launch in Germany and other EU launch countries €7m Q4 2012 Q1 2013 Q2 2013 Q3 2013 ● Regulatory approvals granted in EU, Canada and Australia ● EU launch rollout started in Q4 2013 ● Complete response letter received from FDA in late Dec 2013 ● Genzyme plans to appeal the agency’s decision ● CVR milestone of U.S. approval by March 31, 2014 will not be met Lemtrada™ is developed in collaboration with Bayer HealthCare (1) New Active Substance (NAS) status granted in Europe in Jun 2013 18
  19. 19. Merial Gearing Up to Launch the Next Generation of Flea and Tick Control for Pets ● Companion Animals performance impacted by relatively weak flea and tick season and more competition to Frontline® 9M Sales (€m) €1,560m €1,673m €1,541m 2011 2012 2013 ● Regulatory approvals recently granted for NexGard® for dogs in the U.S. and Broadline® for cats in EU ● 10 significant new products potentially launched over next 3 years evenly split between companion and production animals 19
  20. 20. Alirocumab: Fully-Human PCSK9 mAb Targeting Unmet Needs in Hypercholesterolemia ODYSSEY MONO(2) - Mean LDL-C change (at week 24) ● Global Phase III ODYSSEY program ongoing with 14 clinical studies underway ● Data from Phase III program expected in mid 2014 through Q3 2014(1) - 15.6% ezetimibe ● Initial regulatory submission based on LDL-C planned for early 2015 outside the U.S. ● U.S. regulatory submission in 2015 - 47.2% alirocumab p<0.0001 Alirocumab is developed in collaboration with Regeneron PCSK9: proprotein convertase subtilisin/kexin type 9, an enzyme that can contribute to elevated LDL-C levels through degradation of LDL-C receptors LDL-C : Low Density Lipoprotein-Cholesterol (1) From all Phase III studies except OUTCOMES, CHOICE 1, and CHOICE 2 (2) ODYSSEY MONO is the first study to report data from the Phase III ODYSSEY program 20
  21. 21. Sarilumab: Significant Opportunity for IL-6R Inhibition in Rheumatoid Arthritis (RA) ● Fully human, high affinity, IL-6R mAb administered subcutaneously SARIL-RA-MOBILITY (Phase III Results) Improvement in Signs & Symptoms at Week 24 ACR Response (% of Patients) ● Positive results from SARIL-RAMOBILITY, first Phase III trial in moderate-to-severe RA(1) ● Additional Phase III data expected in 2015 ● Ongoing Phase III studies are: COMPARE, TARGET, ASCERTAIN, EXTEND ● Regulatory submission roll-out expected to start in 2015 ACR20** 66.0* ACR50 58.0* ACR70 46.0* 37.0* 33.0 25.0* 20.0* 17.0 7.0 Placebo + MTX Sarilumab 150 mg + MTX Sarilumab 200 mg + MTX * p<0.0001 versus placebo ** Primary endpoint ACR – American College Of Rheumatology (ACR) Scoring System IL-6R – Interleukin-6 receptor Sarilumab is developed in collaboration with Regeneron (1) Clinically relevant and statistically significant improvements in both sarilumab groups compared to placebo in all three co-primary endpoints: ACR 20, Improvement of physical function and Inhibition of progression of structural damage 21
  22. 22. Dupilumab: Targeting Atopic Dermatitis (AD), Asthma and Nasal Polyposis IL-4 ● Fully human monoclonal antibody binding to IL-4Rα ● Targeting the common IL-4Rα subunit ● Dual IL-4/IL-13 cytokine antagonism with a single agent IL-13 or IL-4R c IL-4R IL-13R1 ● Atopic Dermatitis ● Phase IIa data to be presented at AAAAI in Q1 2014 ● Phase IIb data expected in Q2 2014 ● Plan to initiate Phase III trial in 2014 Type I Receptor Type II Receptor ● Asthma ● Phase IIa data published in NEJM ● Phase IIb ongoing ● Phase IIa ongoing in Nasal polyposis Atopic Dermatitis Dupilumab is developed in collaboration with Regeneron AAAAI:American Academy of Allergy, Asthma & Immunology 22
  23. 23. Sanofi’s Growth Profile Expected to Emerge in Q4 2013 ● In 2014, Sanofi will continue to demonstrate strong performance of Growth Platforms, launch new products and reinforce pre-launch efforts for late-stage projects ● Growth Platforms now account for 72% of sales(1) and Sanofi has returned to sales growth since September 2013(2) ● New product launches are underway or imminent in all of Sanofi's businesses and several high potential R&D projects progressed in 2013 ● The creation of Growth Platforms and the evolution of our R&D pipeline have effectively transformed Sanofi into a major biopharmaceutical player (1) 72.4% in 9M 2013 (2) Sales growth of +6.1% in September 2013 at constant exchange rates and constant structure basis 23