Credit Suisse Healthcare Conference

Transcription

1 Credit Suisse Healthcare Conference Bill Sibold Executive Vice President, Sanofi Genzyme Scottsdale, Arizona - November 8, 2017

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 labelling 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 Company s ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives 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, 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 Agenda Sanofi Q3 and YTD 2017 Performance Specialty Care Continues to Drive Growth for Sanofi New Sanofi Genzyme Immunology Franchise Re-Building a Competitive Position in Oncology 3

4 Company Sales and Business EPS Grew at CER in Q3 Company Sales Business EPS 9,028m 9,053m % at CER +1.1% at CER Q Q Q Q CER: Constant Exchange Rates 4

5 YTD Sales Slightly Higher Despite Significant LoEs 9M 2017 Company Sales 1,228m 26,182m 315m - 133m 26,364m 24,954m +1.2% at CER/CS (4) 9M 2016 BI CHC / SPMSD 9M 2016 CS (1) (2) Sales (3) Fx 9M 2017 LoEs: Losses of Exclusivity (1) Primarily includes SPMSD ( 161m) and BI CHC ( 1,131m on a Full Sales recognition basis; 1,073m when adjusting for progressive sales recognition) in 9M Minor disposal of CHC activities in China is also included. (2) 9M 2016 Sales at Constant Structure (3) Change in sales at CER (4) Growth at Constant Exchange Rates (CER) and Constant Structure (CS) 5

6 Specialty Care and Vaccines Delivered Strong Growth while Diabetes Declined in-line with Expectations Q Sales by Global Business Unit Growth at CER/CS (1) Company Sales 9,053m -0.2% (2) Sanofi Genzyme (Specialty Care) 1,390m +13.9% Sanofi Pasteur (Vaccines) 1,916m +7.2% (2) Diabetes & Cardiovascular 1,298m -14.8% (4) Consumer Healthcare 1,132m +1.0% (5) (6,7,8) General Medicines & Emerging Markets 3,317m -3.1% (3) (1) Growth at CER and Constant Structure on the basis of Q sales including CHC sales from Boehringer Ingelheim, SPMSD sales and others (2) Does not include Emerging Markets sales (3) On a CER basis, growth was +11.0% (4) Consumer Healthcare includes sales in Emerging Markets (5) On a CER basis, growth was +48.5% (6) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care (7) Emerging Markets: World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico (8) Excluding global Consumer Healthcare sales and Vaccines Pictures by Freepik 6

7 Agenda Sanofi Q3 and YTD 2017 Performance Specialty Care Continues to Drive Growth for Sanofi New Sanofi Genzyme Immunology Franchise Re-Building a Competitive Position in Oncology 7

8 Specialty Care Delivers Another Quarter of Double-Digit Growth in Q3 Specialty Care franchise up +13% (+14% first nine months 2017) Dupixent sales reached 75m in the U.S. Kevzara captured 15% NBRx market share of subcutaneously administered IL-6 in month 4 post launch in the U.S. (1) Rare Disease franchise up +2.7% due to phasing in EM and erosion of minor brands Multiple Sclerosis franchise sustained double-digit growth in a competitive market 1,517m 708m 446m 363m Global Specialty Care Franchise Sales 1,633m 698m +2.7% 495m +15.7% 363m +5.0% Q Q % at CER Immunology Rare Diseases Multiple Sclerosis Oncology All growth at CER unless otherwise stated (1) Source: IMS NPA MD September

9 Rare Diseases Franchise Sales Increased 5.3% YTD Fabry franchise grew +10% to 542m Focus primarily on nephrologists and family tree mapping to drive patient identification Pompe franchise grew +10% to 584m Educate on the importance of testing of high risk patients in neurology and neuromuscular specialty areas 1,890m Rare Diseases Sales 2,061m 2,162m +5.3% at CER 9M M M 2017 Other & 9

10 Multiple Sclerosis Franchise Continued to Deliver Strong Growth First 9 Months 2017 Multiple Sclerosis Sales 1,236m 1,540m 362m +18.5% at CER Fastest growing oral RMS product with sales up +27% 9M 2017 (1) 761m 1,178m +26.9% at CER 9M M M % at CER Increasing breadth and depth of prescribing with sales up +19% 9M 2017 Momentum continues, YTD 62% patient growth DMT: Disease Modifying Therapy (1) IMS NPA Market Dynamics 10

11 Attractive Efficacy, Safety, Tolerability and Once-Daily Oral Dosing Profile (1) Approved in 80 countries with >80,000 patients currently treated worldwide Growing and positive experience among patients and neurologists (2) Established safety and tolerability with over 10 years of clinical trial data (3) Only oral RMS treatment to: Significantly reduce the risk of disability progression in two Phase III studies (4) Studied in newly diagnosed RMS patients, 72% of whom remained relapse free (5) RMS: relapsing multiple sclerosis (1) Aubagio (teriflunomide) is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Common side effects with Aubagio led to treatment discontinuation rates 3.3% in clinical trials. (2) Sanofi Genzyme market research (3) The TEMSO Extension Study: Kappos L et al. ECTRIMS P1099, O Connor P et al. ECTRIMS P555. (4) TEMSO study: O Connor P et al. N Engl J Med. 2011;365: ; TOWER study: Confavreux C et al. Lancet Neurol. 2014;13: (5) TOPIC study: Miller AE, et al. Lancet Neurol. 2014;13:

12 Making Steady TRx Share Gains in Highly Competitive Market 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Oral Therapies Have Gained Significant Market Share (1) U.S. TRx Share (3) 9% 10% 10% 11% 12% 74% 17% 61% 55% 52% 50% 29% 34% 37% 38% M % 20% 15% 10% 5% Aubagio is the Fastest Growing Oral Relapsing MS Product (2) U.S. TRx Share (3) 0% Oct-15 Apr-16 Oct-16 Apr-17 Oct-17 Tecfidera 22.0% Gilenya 12.1% 9.6% Injectables Orals Intravenous (1) IMS NPA/NSP, September 2017 (2) Oral category includes Aubagio, Gilenya, Tecfidera ; Intravenous category includes Tysabri, LEMTRADA, Ocrevus ; Injectable category includes Avonex, Betaseron/Betaferon, Copaxone, Glatopa, Rebif, Extavia, Plegridy, Zinbryta (3) IMS NPA, week ending October 20 th,

13 Physician Experience and Real World Patient Results Expected to Drive Continued Growth Approved in more than 65 countries with over 16,000 patients treated commercially worldwide Over 15 years clinical trial data Over 10,000 patient-years of follow up Only relapsing MS therapy in the U.S. which offers efficacy in the absence of continuous treatment (1) No retreatment with Lemtrada after the initial 2 courses in the core studies for a majority of patients through Year 7 (2) ICER report finds Lemtrada provided the highest number of QALYs gained while costing less than all other treatments except supportive care (3) DMTs: Disease-Modifying Therapies (1) Sustained improvements in relapse, disability, and MRI over 5 years in active RRMS in the absence of continuous dosing demonstrated in CARE-MS I and II extension studies (2) The percentages of those not receiving retreatment with Lemtrada were: 61% from CARE-MS I and 52% from CARE-MS II (3) Institute for Clinical and Economic Review (ICER) Final Evidence Report on Disease-Modifying Therapies for Multiple Sclerosis, including daclizumab and ocrelizumab (March

14 Agenda Sanofi Q3 and YTD 2017 Performance Specialty Care Continues to Drive Growth for Sanofi New Sanofi Genzyme Immunology Franchise Re-Building a Competitive Position in Oncology 14

15 Positioned to Grow IL-6 Class and Benefit from Evolving RA (1) Treatment Paradigm MOBILITY TARGET Launch underway in the U.S. and EU U.S. product label includes: Consistent efficacy in both MTX-IR (2) and TNF-IR (3) patients Radiographic data supportive of clinical profile on joint erosion and space narrowing Bi-weekly administration for both 200mg and 150mg doses Improved market access for 2018 Captured 15% NBRx share in new subcutaneous RA IL-6 category in September MTX-IR (3) TNF-IR (4) Consistent Efficacy Data in MTX-IR and TNF-IR patients % of patients achieving ACR20/50/70 at week % 58.0% 60.9% 55.8% ACR % 33.7% 45.6% 37.0% 40.8% 37.0% ACR % 18.2% 24.8% 19.8% ACR70 7.3% 16.3% 19.9% 7.2% Kevzara 200mg Kevzara 150mg Placebo (1) Rheumatoid arthritis (2) MTX-IR: Methotrexate inadequate response (3) TNF-IR: Anti-TNFa inadequate response 15

16 Kevzara - Global Launches of IL-6 mab in RA Ongoing Trends in RA (1) Use of non-tnfα MOA (2) products is increasing Anti-TNFα cycling declining Increasing number of patients on monotherapy Patient preference for sub-cutaneous administration potentially addressed by Kevzara IL-6 plays a key role in the pathophysiology of RA Positive Phase 3 results in MTX-IR and TNF-IR patients (3) Positive monotherapy data versus Humira monotherapy (4) Sub-cutaneous administration with less frequent Q2W (5) dosing (1) Rheumatoid Arthritis (2) Mechanism of Action (3) MTX-IR: methotrexate Inadequate Responder; TNF-IR: TNF Inadequate Responder (4) Based on one head to head superiority study comparing sarilumab and Humira in improving signs and symptoms of RA in adults (MONARCH). A second confirmatory study has not been conducted. Neutropenia, which was not associated with infections, was more common with sarilumab than Humira. Not included in the initial BLA filed with FDA; Humira (adalimumab) is an AbbVie brand (5) Every 2 weeks 16

17 Dupilumab: A Pipeline in a Product First Approval in Adults with Moderate-to-Severe Atopic Dermatitis (AD) Atopic Dermatitis Food Allergy IL-4/ IL-13 Asthma Il-4/IL-13 signaling is considered to be central to many Type-2 mediated diseases Eosinophilic Esophagitis Nasal Polyps (1) Dupilumab is under clinical development in asthma, nasal polyps and eosinophilic esophagitis and its safety and efficacy in these indications have not been fully evaluated by any Regulatory Authority 17

18 Global Rollout Underway Dupixent U.S. launch trend ahead of other recently launched biologics in dermatology Cumulatively over 23,000 patients prescribed since launch Over 7,100 HCPs have prescribed ~70% of target physicians are repeat prescribers 3,000 2,500 2,000 1,500 Weekly TRx since launch Continued progress with U.S. market access 1,000 79% of commercial lives covered (1) 500 Prior Authorization approval rate >80% European approval received in September and launch in Germany planned by end DupixentÒ CosentyxÒ TaltzÒ weeks Source: IMS NPA in the U.S. Last week included is October 13 th (1) Coverage by health plans that currently have a published Dupixent policy but may not have a contract in place 18

19 Positive Phase 3 QUEST Study for Dupilumab in Asthma (1,2) Reduction in severe asthma attacks improvement at Dupilumab Phase 3 QUEST study confirms safety and efficacy profile in uncontrolled persistent asthma (1) First biologic to demonstrate both reduction in exacerbations and FEV 1 improvement in overall population in Phase 3 Overall rate of AEs (3) similar to placebo; ISR (4) more common with dupilumab (17%) than placebo (8%) On track for sbla submission in Q Mean FEV 1 at 52 weeks (5) 12 weeks (5) LIBERTY ASTHMA QUEST Primary endpoints -46% p<0.001 Overall population (6) Placebo p< mL / +9% +150mL / +11% 150 EoS/ L p< % -67% dupilumab +240mL / +18% 300 EoS/ L EoS: Blood eosinophils levels at baseline FEV 1 : Forced Expiratory Volume Results for the 200mg and 300mg dose groups were generally comparable on both exacerbations and FEV 1 (1) Dupilumab is under investigation in Asthma and the safety and efficacy have not been evaluated by any regulatory authorities (2) In adults and adolescents (3) Adverse Events (4) Injection Site Reactions (5) At 300mg every 2 weeks. p<0.001 for all groups (6) Primary Endpoint 19

20 Positive Phase 3 VENTURE Study Further Strengthens Dupilumab s Clinical Profile in Asthma (1,2) Reduction in maintenance corticosteroids use improvement Dupilumab significantly reduced maintenance OCS use in severe asthma patients 80% of dupilumab patients reduced OCS use by at least half compared to 50% for placebo in the overall population LIBERTY ASTHMA VENTURE Primary endpoint and FEV 1 improvement -42% -70% -43% -80% 59% reduction in asthma attacks in overall population despite reduced OCS use Dupilumab significantly increased FEV 1 (+220mL /15%) compared to placebo Safety profile consistent with previous Phase 3 studies All data at week 24 EoS: Blood eosinophils levels at baseline OCS: Oral corticosteroids FEV 1 : Forced Expiratory Volume The overall rates of adverse events, including infections, conjunctivitis (2 events dupilumab, 3 events placebo), and herpes were comparable between the dupilumab and placebo groups. Injection site reactions were more common with dupilumab (9% of Mean FEV 1 p< Overall population (3) p<0.001 Placebo +220mL / +15% Overall population (3) p< EoS/ L dupilumab +320mL / +25% 300 EoS/ L patients) than placebo (4% of patients). (1) Dupilumab is under investigation in Asthma and the safety and efficacy have not been evaluated by any regulatory authorities (2) In adults and adolescents (3) Primary endpoint 20

21 Agenda Sanofi Q3 and YTD 2017 Performance Specialty Care Continues to Drive Growth for Sanofi New Sanofi Genzyme Immunology Franchise Re-Building a Competitive Position in Oncology 21

22 Re-Building a Competitive Position in Oncology Isatuximab (anti-cd38) Product profile potentially differentiated Targets unique epitope with a distinct combination MoA (1) Phase 3 study in relapsed/refractory multiple myeloma initiated in Q Potential indications beyond multiple myeloma being explored Cemiplimab (PD-1) Pivotal Phase 2/3 study in cutaneous squamous cell carcinoma ongoing FDA breakthrough designation received in CSCC (2) Several other indications with other targets/modalities being considered Sanofi s Antibody Drug Conjugates (ADCs) in Phase 1 complementary to our multi-specific antibody platform and IO strategy MoA: Mechanism of Action (1) HDeckert, et al. Clin Cancer Res 2014;20: (2) For the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC 22

23 SAR (PD-1 inhibitor): Registrational Phase 2 Underway Supported by Positive Early Results in CSCC PD-1 (SAR439684) positive Phase 1 study results in advanced CSCC (1) 46.2% ORR (2) and 69.2% DCR (3) Generally well tolerated (4) Anticipated FDA submission in mcscc in Q based on current Phase 2 Additional studies initiated: 1 st line NSCLC (5) : Phase 3 started Advanced BCC (6) : Phase 2 started Recurrent or Metastatic, Platinum-refractory Cervical Cancer: Phase 3 started 40% 20% 0% (20%) (40%) (60%) (80%) PD-1 ORR in Phase 1 CSCC (7) Percent change in target lesions from baseline locally advanced mcscc (100%) months In collaboration with Regeneron SAR is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority; also known as REGN2810 (1) Cutaneous Squamous Cell Carcinoma (2) Overall Response Rate (3) Disease Control Rate (4) The most common treatment-related adverse event of any grade was fatigue (23.1%). All grade 3 or higher adverse events occurred once and included arthralgia (3.8%), maculopapular rash (3.8%), asthenia (3.8%), aspartate aminotransferase (AST) elevation (3.8%) and alanine aminotransferase (ALT) elevation (3.8%). (5) Non-Small Cell Lung Cancer (6) Basal Cell Carcinoma (7) Data presented at ASCO

24 Conclusion 1 2 Specialty Care Continues to Drive Growth for Sanofi Core Rare Disease Brands Remain Strong Multiple Sclerosis Franchise Continues to Deliver Strong Growth U.S. Dupixent Launch Performing Ahead of Expectations Re-Building a Competitive Position in Oncology 24

25 Invitation to Sanofi s Sustaining Innovation Events December 13, 2017 Paris - France December 15, 2017 Boston - U.S. Registration 8:00am Day ends at 2:30pm Registration 8:00am Day ends at 2:30pm Analyst meeting (1) to discuss Sanofi s R&D strategy and development pipeline Lunch meeting with Management Please register by December 1, 2017 Series of Q&A sessions Lunch meeting with Management (1) A live webcast will be available on 25