'

Sanofi's Q2 2015 Earnings Report

Понравилась презентация – покажи это...





Слайд 0

Q2 2015 RESULTS July 30, 2015


Слайд 1

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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 2


Слайд 2

KEY HIGHLIGHTS Olivier Brandicourt Chief Executive Officer 3


Слайд 3

Q2 2015 - A Solid Quarterly Performance Delivering mid-single digit sales growth ● Sales up +4.9% at CER(1) ● Sales growth across all geographies and businesses except Diabetes Posting solid financial results 1 ● Higher OpEx driven by investment in new launches ● Business EPS up +5.1% at CER(2) Bringing innovative medicines to market ● Praluent®: FDA approval and positive CHMP opinion ● Three regulatory filings expected in H2 2015(3) 2 3 4 Building a sustainable path forward ● New alliance with Regeneron in Immuno-Oncology ● Reorganization around five GBUs recently announced(4) GBUs: Global Business Units (1) On a reported basis, Q2 2015 sales were up +16.1% (2) On a reported basis, Q2 2015 Business EPS was up +20.5% (3) FDA submissions of lixisenatide, LixiLan and sarilumab (4) Effective January 1, 2016 4


Слайд 4

Solid Sales and Business EPS Delivered in Q2 2015 Net Sales +€910m +€393m Business EPS +€0.18 +€0.06 +4.9% at +5.1% CER(1) €8,075m Q2 2014 €1.41 €9,378m at CER(1) €1.17 Incremental Sales at CER FX Impact Q2 2015 Q2 2014 (1) On a reported basis, Q2 2015 sales were up +16.1% and Business EPS was up +20.5% Incremental EPS at CER FX Impact Q2 2015 5


Слайд 5

Sales Growth Delivered Across All Businesses in Q2 2015 Except for Diabetes(1) % of Sales Q2 2015 Sales by Business Areas Growth at CER Pharmaceuticals €7,800m +3.7% 21.2% Diabetes €1,988m -3.8% 9.7% Genzyme €907m +26.6% 9.5% Consumer Healthcare €890m +1.3% 5.5% Generics €520m +9.2% 4.2% Oncology €390m +3.6% 33.0% Established Products €3,105m +3.1% 83.1% 9.5% Vaccines €887m +8.6% 7.4% Animal Health €691m +14.2% (1) Q2 2015 sales were up +4.9% at CER and +16.1% on a reported basis 6


Слайд 6

Q2 2015 Diabetes Sales Consistent with Previous Quarter Q2 2015 Diabetes Sales by Geographies (in €m) Total Group Sales excluding Diabetes €7,390m Q1 2015 Q2 2015 U.S. -12.0% -14.0% Western EU +4.7% +6.5% Emerging Markets +18.5% +17.0% RoW -6.0% +4.8% Worldwide -3.2% -3.8% Sales Growth at CER €1,134m -14.0% at CER +7.3% at CER 57% €854m +11.2% at CER 78.8% 43% Diabetes Sales 21.2% €1,988m -3.8% at CER U.S. ex U.S. Expected launch of insulin glargine biosimilar in Europe(1) and Japan in H2 2015 (1) Already launched in two Eastern European markets 7


Слайд 7

Encouraging U.S. Launch Metrics and Global Launch Ongoing (1) (3) Basal Market NRx Shares Toujeo® TRx & NRx Volume Toujeo® Market Access week of April 3 - week of July 17, 2015 week of April 3 - week of July 17, 2015 as of August 1, 2015 Share (%) 80 70 Rx (absolute) (2) Total glargine 67.1% 60 % Lives Covered 7 000 TRx 80% 5 000 4,507 4 000 30 Levemir® 25.6% 73% NRx 50 40 91% 6,539 Cumulative TRx 51,829 6 000 100% 60% Tier 2 3 000 45% 40% Tier 2 2 000 20 10 1 000 0 0 Cumulative NRx 40,891 20% Tier 3 Week 16 Week 15 Week 14 Week 13 Week 12 Week 11 Week 9 Week 10 Week 8 Week 7 Week 6 Week 5 Week 4 Week 3 Week 2 Week 1 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12 Week 13 Week 14 Week 15 Week 16 28% 0% Commercial Medicare EU launch ongoing and approval in Japan, Canada, Australia recently granted (1) Basal market includes Toujeo®, Lantus®, Levemir® (a Novo Nordisk brand) and NPH - Source: IMS Weekly Data (2) Total glargine includes Toujeo® and Lantus® (3) Source: IMS Weekly Data 8


Слайд 8

Rare Disease Franchise Sustained Growth Momentum and Strengthened Leadership(1) in Q2 2015 Genzyme Rare Disease Sales (€m) €647m +9.1% at CER €121m Others Others €146m Fabrazyme €165m €540m Myozyme Cerdelga €199m Q2 2014 Q3 2014 Q4 2014 Q1 2015 & (2) Cerezyme Q2 2015 (1) Cerezyme® + Cerdelga® value share is 74% and Fabrazyme® value share is 58% based on Q2 2015 reported sales by Sanofi and Shire (2) Cerdelga® sales were €16m in Q2 2015 9


Слайд 9

Multiple Sclerosis Franchise Sales Now Annualizing(1) Over €1bn Genzyme Multiple Sclerosis Sales (€m) New Global Campaign €260m +118.4% at CER €56m €103m Q2 2014 €204m Q3 2014 Q4 2014 Q1 2015 Q2 2015 * 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. ® Lemtrada Aubagio (1) Multiplying Q2 2015 sales of €260m by four provides a hypothetical annual run rate of over €1bn sales 10


Слайд 10

Vaccines Showed Broad Sales Momentum in Q2 2015 Sanofi Pasteur Sales (€m) €887m A Breakthrough Innovation to Help Reduce the Burden of Dengue(2) €718m +8.6% at CER Influenza Vaccines Polio/Pertussis/Hib Meningitis/Pneumo Adult Boosters Travel/Endemic ● Regulatory submissions in key endemic countries in Asia and Latin America completed in June 2015 ● First license anticipated before year-end 2015 Other(1) Q2 2014 Q2 2015 Targeting over 65m doses of flu vaccines to be distributed in the U.S. in 2015 (1) Includes VaxServe, a U.S. healthcare supplier serving primary care physician offices, community immunization providers, immunizing pharmacies, travel clinics and corporations (2) WHO, 2012, Global Strategy for Dengue Prevention and Control 11


Слайд 11

Animal Health Continued its Strong Recovery in Q2 2015 Merial Sales Growth (at CER) NexGard® U.S. Campaign (1) +12.7% +13.5% +14.2% +11.5% +6.2% -1.6% -5.7% Q2 2013 -6.4% -6.3% Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Five consecutive quarters of strong sales growth (1) Merial sales growth excluding NexGard® was +7.8% at CER in Q2 2015 12


Слайд 12

Sales Growth Delivered Across All Geographies in Q2 2015 Q2 2015 Sales by Geographies (in €m) (2) Western EU €1,998m +3.4% at CER Emerging Markets Sales by Region RoW €948m +8.2% at CER 10.1% €934m €982m 21.3% 33.9% Emerging Markets (1) €3,182m €602m €616m +7.5% at CER U.S. 34.7% €3,250m +2.1% at CER Africa & Middle Eastern Europe, East Russia & Turkey Growth at CER +9.0% +3.0% (1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, the Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, South Korea, Australia, and New Zealand (2) RoW: Japan, South Korea, Canada, Australia, and New Zealand Asia Latin America +9.3% +7.1% 13


Слайд 13

New Strategic Alliance with Regeneron to Develop Cancer Treatments in Emerging Field of Immuno-Oncology ● 1 Establish Sanofi’s presence in immuno-oncology, a rapidly growing and promising approach to treat cancer  Committing to Immuno Oncology ● 2 Expand our oncology pipeline, developing best-in-class new antibodies and novel combination products(1)  ● 3 Significant unmet needs remain despite advances shown with checkpoint inhibitors Alliance includes PD-1(2) in Phase I and a portfolio of antibodies, including LAG3, GITR and PD-L1 currently in Preclinical development(3) Accelerate development of multiple drug candidates in a fast-evolving IO field with a scale and focus beyond our existing discovery agreement PD-1: Programmed death protein 1 PD-L1: Programmed death ligand 1 IO: Immuno-Oncology (1) Including bi-specifics antibodies (2) REGN2810 (3) Subject to opting in LAG-3: Lymphocyte activation gene 3 GITR: Glucocorticoid-Induced Tumor-necrosis-factor-Receptor-related protein 14


Слайд 14

Ready to Launch Praluent® (alirocumab) in the U.S. and EU FDA approval granted on July 24, 2015  Indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol (LDL-C) 75 mg dose Positive CHMP opinion on July 23, 2015(1) 150 mg dose  Indicated in adults with primary hypercholesterolemia (1) EC regulatory decision expected in late September 2015 (HeFH and non-familial) or mixed dyslipidaemia, as an adjunct to diet in patients unable to reach their LDL-C goals with a maximally-tolerated statin and patients who are statin intolerant, or for whom a statin is contraindicated 15


Слайд 15

Additional Clinical Milestones and Regulatory Filings Expected in H2 2015 Key Milestones in H2 2015 lixisenatide Type 2 Diabetes Positive ELIXA study results supported U.S. regulatory submission in late July 2015(1) (2) Type 2 Diabetes Positive LixiLan-O top-line results demonstrated superiority over insulin glargine or lixisenatide on HbA1c reduction(3) LixiLan-L results expected in Q3 2015(3) sarilumab Rheumatoid Arthritis 3 Phase III trials recently met their primary endpoints(4) Regulatory submission expected in late 2015 in the U.S. and Q4 2016 in EU (1) ELIXA evaluated CV outcomes in Type 2 Diabetes patients after Acute Coronary Syndrome during treatment with lixisenatide (2) LixiLan is a once-daily fixed-ratio combination of insulin glargine and lixisenatide (3) LixiLan-O evalutates the combination of insulin glargine and lixisenatide in patients insufficiently controlled on OADs. LixiLan-L focuses on patients not at goal on basal insulin. The ongoing LixiLan-L study will be completed in Q3 2015. Following an analysis of results from both Phase III studies, LixiLan-O and LixiLan-L, Sanofi will determine the next steps in the regulatory process. Currently, regulatory submissions are planned for Q4 2015 in the U.S. and Q1 2016 in the EU. (4) SARIL-RA-TARGET, SARIL-RA-EASY and SARIL-RA-ASCERTAIN 16


Слайд 16

A New Organizational Model with Five Global Business Units Is a Necessary Step to Drive Focus and Simplification Diabetes & Cardiovascular P. Witz General Medicines & Emerging Markets P. Guenter Sanofi Genzyme (Specialty Care) Sanofi Pasteur (Vaccines) Merial (Animal Health) D. Meeker O. Charmeil C. Hellmann  Diabetes  CHC  Rare diseases  Cardiovascular  Established products  Multiple Sclerosis  Generics  Oncology &  Human vaccines  Animal Health products  Immunology  Emerging markets(1)  Similar to R&D and Industrial Affairs, all functions will be globalized(2) New organization implemented beginning in January 2016(3) (1) All pharmaceutical businesses in Emerging markets to report to General Medicine & Emerging Markets GBU (2) Functions include Research & Development, Industrial Affairs, Finance, Human Resources, Business Development & Strategy, External Affairs, Information Systems, Medical, Legal, Compliance, Procurement (not an exhaustive list of functions) (3) The process of legal and social consultation will be followed as required 17


Слайд 17

Sanofi to Host an IR Seminar in Q4 2015 ● Outlining a roadmap towards 2020 Meet ● Sharing the outcome of the ongoing business review Management ● Presenting further progress of our R&D pipeline ● Offering opportunities to interact with management Friday November 6th, 2015 from 8:30 to 16:00 in Sanofi HQ - Paris 18


Слайд 18

FINANCIAL RESULTS Jérôme Contamine Executive Vice President, Chief Financial Officer 19


Слайд 19

Sustained U.S. Dollar Strength Led to Strong FX Tailwind on Top and Bottom Line Again in Q2 2015 Quarterly Currency Impact Net Sales(1) Business EPS +15.4% +11.2% +9.9% +€0.18 +€910m +10.2% +€782m +€0.12 +2.7% +€229m Q1 2014 Q2 2014 Q3 2014 -€81m Q4 2014 Q1 2015 Q2 2015 +1.5% Q1 2014 Q2 2014 Q3 2014 -€0.03 -1.0% -€497m -6.2% +€0.02 Q4 2014 Q1 2015 Q2 2015 -2.2% -€443m -5.5% -€0.11 -9.1% -€0.10 -8.9% (1) Main currency impact on sales in Q2 2015: U.S. Dollar (+€645m); Chinese Yuan (+€99m); Brazilian Real (-€33m); Russian Ruble (-€31m) 20


Слайд 20

Business Operating Income Up +4.7% at CER Despite OpEx Increase of +3.7% at CER in Q2 2015 €m Q2 2015 Q2 2014 9,378 % Change % Change (reported €) (CER) 8,075 +16.1% +4.9% 83 71 +16.9% +0.0% (2,938) (2,608) +12.7% +4.8% 6,523 5,538 +17.8% +4.8% R&D (1,290) (1,188) +8.6% -0.3% SG&A (2,648) (2,255) +17.4% +5.9% (20) 54 - - 30 26 - - (29) (30) - - Business operating income 2,566 2,145 +19.6% +4.7% Business operating margin 27.4% 26.6% - - Net sales Other revenues Cost of sales Gross profit Other current operating income & expenses Share of Profit/Loss of associates Minority interests CER: Constant Exchange Rates 21


Слайд 21

Mid-Single Digit Business EPS Growth at CER in Q2 2015 €m Q2 2015 Q2 2014 Business operating income 2,566 Net financial expenses Income tax expense % Change % Change (reported €) (CER) 2,145 +19.6% +4.7% (112) (94) - - (614) (514) - - -25.0% -25.0% - - Business net income 1,840 1,537 +19.7% +4.2% Net margin 19.6% 19.0% - - Business EPS €1.41 €1.17 +20.5% +5.1% 1,314.5 - - Effective tax rate Average number of shares outstanding (m) (1) CER: Constant Exchange Rates (1) Number of shares outstanding on June 30, 2015: 1,306.2m 1,305.9 22


Слайд 22

Gross Margin Consistent with FY 2015 Expectations Gross Margin (%) ● Cost of Sales (CoS) of €2,938m in Q2 2015, up +4.8% at CER 69.6% 68.6% ● Gross margin of 69.6% in Q2 2015 reflecting 1.0 pt increase over Q2 2014: ● Driven by favorable FX impact ● Positive impact from Genzyme and Renagel® offsetting negative impact of Vaccines mix and Lantus® U.S. Q1 Q2 Q3 2014 Q4 Q1 Q2 2015 23


Слайд 23

OpEx Grew +14.4% in Reported and +3.7% at CER in Q2 2015 Operating Expenses (€m) €3,938m ● Q2 2015 OpEx of €3,938m, up +3.7% at CER €3,443m €1,290m ● SG&A expenses of €2,648m (28.2% of sales), up +17.4% or +5.9% at CER R&D €1,188m SG&A ● R&D expenses of €1,290m (13.8% of sales), up +8.6% or stable at CER €2,255m €2,648m Q1 Q2 Q3 2014 Q4 Q1 Q2 2015 Targeting mid-single digit OpEx growth at CER in 2015 24


Слайд 24

Regeneron Agreement Terms Provide Critical Investment Mass for IO Target Discovery and Antibody Development Key IO Collaboration Terms Key Terms for PD-1 inhibitor (REGN2810) ● $265m upfront payment for access to Regeneron’s research capabilities and technologies in IO ● $375m upfront payment ● Sanofi and Regeneron will invest over $1bn in R&D (split 75/25) ● Worldwide profits shared 50/50 ● Sanofi will re-allocate $75m to IO from existing collaboration(1) ● Sanofi opt-in rights at Proof of Concept ● After opt-in, partners share R&D costs and alternate development lead and U.S. commercialization(2) ● Sanofi and Regeneron will invest $650m in R&D (split 50/50) ● Regeneron leads development and consolidates U.S. sales ● Sanofi consolidates non-U.S. sales ● $375m milestone if sales of a PD-1 and any other collaboration antibody sold for use in combination with a PD-1 exceed $2bn over 12 months ● Worldwide profits shared 50/50 Exclusive IO antibody collaboration with Regeneron will last up to 8 years(3) IO: Immuno-Oncology (1) Sanofi to re-allocate $75m (over 3 years) to IO from its $160m annual contribution to existing collaboration (2) For antibodies that Regeneron leads development, development costs will be shared equally. For antibodies that Sanofi leads development, Sanofi will prefund and Regeneron will reimburse 50% of the costs through the IO collaboration development balance, in an annual amount equal to 10% of the Regeneron share of profits (3) Five years with an ability to extend the collaboration for selected ongoing programs for an additional three years 25


Слайд 25

Free Cash Flow Increased 29.0% in H1 2015 Net Debt (in €m) €801m €3,694m €3,751m €363m €462m €7,171m Net Debt (1) Dec 31, 2014 FCF €3,084m €9,726m €1,243m €667m Net Cash from Operating Activities (2) CapEx Proceeds from Issuance of Shares Share Repurchase Acquisitions, Licensing, Net of Disposals Dividend FCF: Free Cash Flow (1) Including derivatives related to the financial debt +€302m at December 31st 2014 and +€305m at June 30th 2015 (2) Excluding Restructuring costs (3) Other including Restructuring costs and Fx impact Other (3) Net Debt (1) Jun 30, 2015 26


Слайд 26

Exclusivity Losses and Higher OpEx Expected in H2 2015 H2 2015 ● Slower sales growth of Venezuela and Merial ● Expected launch of insulin glargine biosimilar in Europe(1) and Japan ● Generic competition to Plavix® in Japan and Renagel® in Europe and possibly the U.S. ● Accelerating OpEx growth given: ● New R&D funding of Immuno-Oncology alliance, Toujeo® Phase IV program, dupilumab Phase III in Asthma ● Investment in Praluent® launch and Toujeo® DTC campaign (1) Already launched in two Eastern European markets 27


Слайд 27

Outlook for 2015 - Investing in Future Growth Drivers FY 2015 Business EPS Growth FX impact on Business EPS Stable to slightly growing at CER(1,2) Approximately +10%(3) (1) Barring major unforeseen adverse events (2) FY 2014 Business EPS of €5.20 (3) Difference between variation on a reported basis and variation at CER, when applying June 2015 average exchange rates to the remaining two quarters of the year 28


Слайд 28

APPENDICES R&D Pipeline 29


Слайд 29

Late Stage Pipeline – Pharma & Vaccines Registration Phase III N LixiLan patisiran (ALN-TTR02) lixisenatide + insulin glargine Fixed-Ratio / Type 2 diabetes siRNA inhibitor targeting TTR Familial amyloid polyneuropathy SAR342434 N Anti-IL6R mAb Rheumatoid arthritis dupilumab Toxoid vaccine Rotavirus lixisenatide Live attenuated tetravalent Rotavirus oral vaccine GLP-1 agonist Type 2 diabetes, U.S. Kynamro® (mipomersen) Apolipoprotein B-100 antisense Severe HeFH, U.S. VaxiGrip® QIV IM Dengue Quadrivalent inactivated influenza vaccine Mild-to-severe dengue fever vaccine N revusiran (ALN-TTRsc) N N PR5i Jevtana® (cabazitaxel) Anti-IL4Rα mAb Atopic dermatitis, Asthma N Anti-PCSK9 mAb Hypercholesterolemia, EU siRNA inhibitor targeting TTR Familial amyloid cardiomyopathy N insulin lispro Type 1+2 diabetes sarilumab Praluent® (alirocumab) Clostridium difficile DTP-HepB-Polio-Hib Pediatric hexavalent vaccine, U.S., EU Metastatic prostate cancer (1L) SYNVISC-ONE® Medical device Pain in hip OA N New Molecular Entity Oncology Diabetes Solutions Rare Diseases Biosurgery Immune Mediated Diseases Infectious Diseases Cardiovascular / Renal Diseases Vaccines Ophthalmology Age Related Degenerative Diseases 30


Слайд 30

Early Stage Pipeline – Pharma & Vaccines Phase II dupilumab isatuximab Anti-IL4Rα mAb Nasal polyposis; Eosinophilic oesophagitis vatelizumab Rabies VRVg Anti-CD38 naked mAb Multiple myeloma N Anti-VLA 2 mAb Multiple sclerosis SAR156597 N SAR125844 C-MET kinase inhibitor Purified vero rabies vaccine N NSCLC N GZ402671 IL4/IL13 Bi-specific mAb Idiopathic pulmonary fibrosis olipudase alfa Anti-IL6R mAb Uveitis N Tuberculosis Oral GCS Inhibitor Fabry Disease sarilumab Meningitis ACYW conj. 2nd generation meningococcal conjugate infant vaccine rhASM Niemann-Pick type B Combination Recombinant subunit vaccine N N ferroquine / OZ439 Antimalarial N New Molecular Entity Oncology Diabetes Solutions Rare Diseases Biosurgery Immune Mediated Diseases Infectious Diseases Cardiovascular / Renal Diseases Vaccines Ophthalmology Age Related Degenerative Diseases 31


Слайд 31

Early Stage Pipeline – Pharma & Vaccines Phase I N GZ402668 GLD52 (anti-CD52 mAb) Relapsing multiple sclerosis N SAR566658 Maytansin-loaded anti-CA6 mAb Solid tumors N SAR113244 Anti-CXCR5 mAb Systemic lupus erythematosus SAR408701 N Anti-protofibrillar AB mAb Alzheimer’s disease REGN2810 PD-1 inhibitor N N GLP-1 / GCGR agonist Diabetes Streptococcus pneumonia GZ389988 Meningitis & pneumonia vaccine N Herpes Simplex Virus Type 2 TRKA antagonist Osteoarthritis N StarGen® HSV-2 vaccine N Gene therapy Stargardt disease Cancer SAR425899 N neo GAA Pompe Disease Anti-CEACAM5 ADC Solid tumors SAR228810 GZ402666 SAR125844 C-MET kinase inhibitor UshStat® N Gene therapy Usher syndrome 1B Solid tumors N SAR439152 Myosin inhibitor Hypertrophic cardiomyopathy N New Molecular Entity Oncology Diabetes Solutions Rare Diseases Biosurgery Immune Mediated Diseases Infectious Diseases Cardiovascular / Renal Diseases Vaccines Ophthalmology Age Related Degenerative Diseases 32


Слайд 32

R&D Pipeline Summary Table(1) Phase I Phase II Phase III Registration TOTAL Oncology 3 2 0 0 5 Diabetes Solutions 1 0 1 1 3 Cardiovascular / Renal Diseases 1 0 0 1 2 Immune Mediated Diseases 2 2 2 0 6 Infectious Diseases 0 1 0 0 1 Ophthalmology 2 0 0 0 2 Rare Diseases 2 2 2 0 6 Age Related Degenerative Diseases 1 0 0 0 1 Vaccines 2 3 3 2 10 14 10 8 4 TOTAL 26 24 (1) Excluding life cycle management programs 12 36 NMEs & Vaccines 33


Слайд 33

Expected R&D Milestones Product Event Timing Praluent® (alirocumab) Expected EC regulatory decision in Hypercholesterolemia Q3 2015 LixiLan Expected Phase III top line results in Diabetes Q3 2015 Vaxigrip® QIV IM (3+ years) Expected EU regulatory submission Q4 2015 Dengue vaccine Expected regulatory decision in endemic countries Q4 2015 LixiLan Expected U.S. regulatory submission in Diabetes Q4 2015 sarilumab Expected U.S. regulatory submission in Rheumatoid Arthritis Q4 2015 PR5i vaccine (DTP-HepB-Polio-Hib) Expected U.S. regulatory decision Q4 2015 LixiLan Expected EU regulatory submission in Diabetes Q1 2016 PR5i vaccine (DTP-HepB-Polio-Hib) Expected EU regulatory decision Q1 2016 Meningitis ACYW conj. vaccine Expected start of Phase III trial Q1 2016 dupilumab Expected Phase III top line results in Atopic Dermatitis Q1 2016 Rotavirus vaccine Expected regulatory submission in India Q2 2016 insulin lispro Expected Phase III top line results in Diabetes Q2 2016 34


Слайд 34

APPENDICES FINANCE 35


Слайд 35

2015 Currency Sensitivity Business EPS Currency Sensitivity Currency Variation Business EPS Sensitivity U.S. Dollar -0.05 USD/EUR +EUR 0.10 Japanese Yen +5 JPY/EUR -EUR 0.03 Russian Ruble +10 RUB/EUR -EUR 0.06 Currency Exposure on Q2 2015 Sales Russian Ruble Chinese Yuan 1.6% 5.4% Others Brazilian 19.3 % Real 3.2% Canadian $ 1.5% Australian $ 1.5% Bristish £ 2.0% Japanese Yen 5.5% US $ 35.6% Currency Average Rates Mexican Peso 1.4% Q2 2015 % change EUR/USD € 23.0% Q2 2014 1.37 1.10 -19.7% EUR/JPY 140.03 134.14 -4.2% EUR/CNY 8.54 6.85 -19.8% EUR/RUB 47,96 58,12 +21.2% 36


Слайд 36

Business Net Income Statement Second quarter 2015 € million Net sales Other revenues Group Total Q2 2015 Q2 2014 9,378 83 Pharmaceuticals Animal health Other change Q2 2015 Q2 2014 change Q2 2015 Q2 2014 change Q2 2015 Q2 2014 change Q2 2015 Q2 2014 8,075 16.1% 7,800 6,820 14.4% 887 718 23.5% 691 537 28.7% - - 71 16.9% 6 33.3% - - 12.7% 18.0% - - 35.0% - - 25.7% - - 33.3% - - Cost of sales (2,938) (2,608) As % of net sales (31.3%) (32.3%) Gross profit Vaccines 67 58 15.5% 9.4% (2,058) (30.2%) 5,615 4,820 72.0% 70.7% (1,104) (1,030) (14.2%) 17.8% (2,252) (28.9%) (15.1%) (2,216) (1,930) 8 7 14.3% 28.6% (350) (48.8%) 445 375 50.2% 52.2% (142) (123) (16.0%) 16.5% (450) (50.7%) (17.1%) (188) (142) 8 (200) (37.2%) 463 343 67.0% 63.9% (44) (35) (6.4%) 18.7% (236) (34.2%) (6.5%) (244) (183) 6,523 5,538 As % of net sales 69.6% 68.6% Research & development expenses (1,290) (1,188) As % of net sales (13.8%) (14.7%) Selling and general expenses As % of net sales (2,648) (2,255) (28.2%) (27.9%) (28.4%) (28.3%) (21.2%) (19.8%) (35.3%) (34.1%) (20) 54 (11) 42 1 3 5 11 (15) (2) 30 26 29 25 1 1 - - - - (29) (30) (29) (30) - - - - - - 2,566 2,145 2,284 1,897 117 114 180 136 (15) (2) 27.4% 26.6% 29.3% 27.8% 13.2% 15.9% 26.0% 25.3% (112) (94) Other current operating income/expenses Share of profit/loss of associates (1) Net income attributable to non-controlling interests Business operating income As % of net sales Financial income and expenses Income tax expense Tax rate (2) (614) 17.4% 19.6% 7.2% 14.8% 20.4% 15.4% 32.4% 2.6% 32.4% (514) 25.0% 8.6% 25.0% Business net income 1,840 1,537 As % of net sales 19.6% 1.41 1.17 19.7% 19.0% Business earnings per share(3) (in euros) 20.5% (1) Net of tax (2) Determined on the basis of Business income before tax, associates and non-controlling interests (3) Based on an average number of shares outstanding of 1,305.9 million in the second quarter of 2015 and 1,314.5 million in the second quarter of 2014 37


Слайд 37

Business Net Income Statement First Half 2015 € million Net sales Other revenues Group Total Pharmaceuticals change H1 2015 H1 2014 change H1 2015 H1 2014 change H1 2015 H1 2014 change 18,188 15,917 14.3% 15,255 13,517 12.9% 1,584 1,346 17.7% 1,349 1,054 28.0% 163 154 5.8% 129 126 2.4% 14 14 - 20 14 42.9% - - 11.7% 9.8% 18.0% 20.6% - - (5,724) (5,124) (31.5%) (32.2%) Gross profit 12,627 69.4% 10,947 68.8% Research and development expenses (2,489) (2,327) As % of net sales (13.7%) (14.6%) (5,086) (4,333) (28.0%) Other current operating income/expenses Share of profit/loss of associates (1) Net income attributable to non-controlling interests Business operating income As % of net sales Financial income and expenses Income tax expense Tax rate (2) Other H1 2014 As % of net sales Selling and general expenses As % of net sales Animal health H1 2015 Cost of sales As % of net sales Vaccines (4,442) (4,046) (29.1%) (29.9%) (826) (700) (52.1%) (52.0%) 15.3% 10,942 71.7% 9,597 71.0% 14.0% 772 48.7% 660 49.0% 7.0% (2,143) (2,025) 5.8% (262) (230) (14.0%) (15.0%) (16.5%) (17.1%) (4,310) (3,721) (344) (271) (27.2%) (28.3%) (27.5%) (21.7%) (87) 29 (39) 19 61 39 61 (62) (65) (62) 4,964 4,290 27.3% (456) (378) (33.8%) (35.8%) 17.0% 913 67.7% 690 65.5% 32.3% - - 13.9% (84) (72) 16.7% - - (6.2%) (6.8%) (432) (341) 26.7% - - (20.1%) (32.0%) (32.4%) 2 1 5 17 (55) (8) 33 - 6 - - - - (65) - - - - - - (55) (8) 3,566 3,084 As % of net sales 19.6% 15.9% 2.34 168 166 10.6% 12.3% 1.2% 402 294 29.8% 36.7% 27.9% 15.6% 19.4% 2.73 3,838 28.4% 26.9% 25.0% Business net income 4,449 29.2% 15.8% (1,036) 25.0% H1 2014 (170) (1,189) 15.7% 27.0% (209) 17.4% H1 2015 Business earnings per share(3) (in euros) 16.7% (1) Net of tax (2) Determined on the basis of Business income before tax, associates and non-controlling interests (3) Based on an average number of shares outstanding of 1,307.2 million in the first semester of 2015 and 1,317.2 million in the first semester of 2014 38


Слайд 38

Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi € million Q2 2015 Q2 2014 1,840 1,537 (611) (624) Impairment of intangible assets (1) (71) Fair value remeasurement of contingent consideration liabilities 70 (124) (28) (84) - - 206 274 214 207 25 13 Business net income Amortization of intangible assets (1) Restructuring costs Other gains and losses, and litigation Tax effect of: amortization of intangib le assets impairment of intangib le assets fair value remeasurement of contingent consideration liab ilities other gains and losses, and litigation restructuring costs - (22) Share of items listed above attributable to non-controlling interests Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures Net income attributable to equity holders of Sanofi Consolidated earnings per share(2) (in euros) - (110) 2 3 (65) (24) 1,302 777 1.00 19.7% 29 (111) Other tax items - 14 Change 0.59 67.6% (1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €582 million in the second quarter of 2015 and €601 million in the second quarter of 2014 (2) Based on an average number of shares outstanding of 1,305.9 million in the second quarter of 2015 and 1,314.5 million in the second quarter of 2014 39


Слайд 39

Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi € million H1 2015 3,566 Amortization of intangible assets (1) Impairment of intangible assets Fair value remeasurement of contingent consideration liabilities Restructuring costs Other gains and losses, and litigation(2) Tax effect of: amortization of intangib le assets impairment of intangib le assets fair value remeasurement of contingent consideration liab ilities other gains and losses, and litigation restructuring costs 3,084 (1,229) (1,301) (28) (74) 71 (132) (381) (135) - 35 561 Business net income H1 2014 522 431 10 (15) 451 26 14 - 44 (111) (110) 3 4 Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures (127) (32) Net income attributable to equity holders of Sanofi 2,325 1,861 1.78 15.6% (13) 135 Change 1.41 Other tax items (3) Share of items listed above attributable to non-controlling interests Consolidated earnings per share(4) (in euros) 24.9% (1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €1,172 million in the first semester of 2015 and €1,258 million in the first semester of 2014 (2) Day one profit on Alnylam shares presented in financial result (3) Tax on dividends paid to shareholders of Sanofi (4) Based on an average number of shares outstanding of 1,307.2 million in the first semester of 2015 and 1,317.2 million in the first semester of 2014 40


Слайд 40

Consolidated Income Statements € million Q2 2015 Gross profit 8,075 18,188 15,917 71 163 154 (2,938) Cost of sales H1 2014 83 Other revenues H1 2015 9,378 Net sales Q2 2014 (2,608) (5,724) (5,124) 6,523 5,538 12,627 10,947 Research and development expenses (1,290) (1,188) (2,489) (2,327) Selling and general expenses (2,648) (2,255) (5,086) (4,333) Other operating income Other operating expenses Amortization of intangible assets 47 106 83 116 (67) (52) (170) (87) (611) (624) (1,229) (1,301) Impairment of intangible assets (1) (71) (28) (74) Fair value remeasurement of contingent consideration liabilities 70 (124) 71 (132) Restructuring costs (28) (84) (381) (135) Operating income 1,995 1,246 3,398 2,674 Financial expenses (134) (145) (267) (292) 22 51 58 157 1,883 1,152 3,189 2,539 (519) (350) (739) (624) (35) 2 (66) 7 1,329 804 2,384 1,922 Financial income Income before tax and associates and joint ventures (1) Income tax expense Share of profit / loss of associates and joint ventures Net income Net income attributable to non-controlling interests Net income attributable to equity holders of Sanofi Average number of shares outstanding (million) Consolidated earnings per share (in euros) 27 27 59 61 1,302 777 2,325 1,861 1,305.9 1,314.5 1,307.2 1,317.2 1.00 0.59 1.78 1.41 (1) In 2015, including a tax on dividends paid to shareholders of Sanofi: (111)M€ compared to (110)M€ in 2014 41


Слайд 41

Cash Flow Statements H1 2015 H1 2014 3,566 3,084 Depreciation, amortization and impairment of property, plant and equipment and software 628 582 Gains and losses on disposals of non-current assets, net of tax (44) (97) (218) (98) 3,932 3,471 Changes in working capital (181) (552) Acquisitions of property, plant and equipment and software (667) (529) Free cash flow 3,084 2,390 Acquisitions of intangible assets excluding software (280) (108) Acquisitions of investments in consolidated undertakings including assumed debt (169) (1,679) Restructuring costs (345) (382) 86 179 462 240 Dividends paid to shareholders of Sanofi (3,694) (3,676) Acquisition of treasury shares (1,243) (1,010) 1 - (16) (6) (391) (37) (50) (62) (2,555) (4,151) € million Business net income Other non cash items (1) Operating cash flow before changes in working capital (1) (1) Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets net of tax Issuance of Sanofi shares Disposals of treasury shares Transactions with non-controlling interests including dividends Foreign exchange impact Other items Change in net debt (1) Excluding restructuring costs 42


Слайд 42

Balance Sheets ASSETS € million June 30, 2015 Dec 31, 2014 LIABILITIES & EQUITY € million June 30, 2015 Dec 31, 2014 Property, plant and equipment 10,540 10,396 Equity attributable to equity holders of Sanofi 56,618 56,120 Intangible assets (including goodwill) Non-current financial assets & investments in associates and deferred tax assets Non-current assets 55,062 53,740 Equity attributable to non-controlling interests 156 148 10,296 9,819 Total equity 56,774 56,268 75,898 73,955 Long-term debt Non-current liabilities related to business combinations and to non-controlling interests Provisions and other non-current liabilities 10,770 13,276 1,132 1,133 9,206 9,578 3,742 4,105 Non-current liabilities 24,850 28,092 Accounts payable & Other current liabilities 12,192 11,363 141 131 3,962 1,538 16,295 13,032 4 - 97,923 97,392 Deferred tax liabilities Inventories, accounts receivable and other current assets Cash and cash equivalents Current assets 17,308 16,086 4,701 7,341 22,009 23,427 Current liabilities related to business combinations and to non-controlling interests Short-term debt and current portion of long-term debt Current liabilities Assets held for sale or exchange TOTAL ASSETS 16 10 97,923 97,392 Liabilities related to assets held for sale or exchange TOTAL LIABILITIES & EQUITY 43


Слайд 43


×

HTML:





Ссылка: