DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
2017/01 - JP Morgan HC Conference
1. JP Morgan Healthcare Conference
Olivier Brandicourt – Chief Executive Officer
San Francisco - January 10, 2017
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 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, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to
update or revise any forward-looking information or statements.
4. Focused on key launches: Toujeo®, Soliqua™, Praluent®, Dengvaxia®
2016: Sanofi Progressing on its Strategic Priorities
4
Vaccines JV in Europe discontinued(2); EU Generics to be carved out
5 NMEs(3) start Ph 3: isatuximab, PD-1, sotagliflozin, olipudase alfa, NeoGAA
Priority review granted for Dupixent® in Atopic Dermatitis
Streamlined GBU organization driving financial performance
Simplify
Reshape
Innovation
Launches
BI asset swap makes Sanofi a global leader in Consumer Healthcare(1)
(1) Sanofi and Boehringer Ingelheim confirm closing of business swap on January 1st, 2017
(2) Sanofi Pasteur and MSD end joint vaccines business in Europe on January 2nd, 2017
(3) NME: New Molecular Entity
Icons designed by Freepik
6. Sanofi
Genzyme
(Specialty Care)
● Rare diseases
● Multiple Sclerosis
● Immunology
● Oncology
Shaping a Leading Portfolio of Diversified Businesses with
an Attractive Long-term Growth Profile
6
(1) YTD September at constant exchange rates (CER)
(2) Excluding Venezuela and Consumer Healthcare (CHC)
(3) On a comparable structure basis and excluding Venezuela
(4) BI sales for YTD September 2016
General
Medicines &
Emerging Markets
● Leader in EM
● EU Generics
(YTD Sep sales
€610m) carve-out
expected to take
12-24 months
Consumer
Healthcare
● Allergy
● Cough & Cold
● Digestive
● Pain
● VMS
€3,684m
+19.1%
Diabetes &
Cardiovascular
● Leading basal
insulin franchise
● PCSK9
9 Months 2016 Sales by Global Business Unit(1)
Sanofi
Pasteur
(Vaccines)
● Flu vaccine
● Polio/Pertussis/Hib
● Meningitis/
Pneumonia
● Dengue
€3,225m
+11.0%
€10,853m(2)
-1.8%
€4,687m
-3.9%
€2,496m
+2.3%(3)
+
Boehringer
Ingelheim(4)
€1,132m
7. 4.4%
4.4%
4.4%
4.2%
3.5%
2.4%
1.9%
1.0%
73.8%
BI Asset Swap: A Strong Strategic Rationale for Our
Ambitions in Consumer Healthcare (CHC)
7
Other
Reckitt Benckiser
Pfizer
J&J
GSK
Takeda
P&G
Bayer +
(1) Nicholas Hall & Company, MAT Q3 2016
(2) Excludes BI CHC in China
● Market share of 4.4% in 2016(1,2)
● Leverage scale in a fragmented market
● Opportunity for strategic consolidation
● Expand global footprint
● Brand equity offers more sustainable
revenue streams
● No patent cliff
● ‘Ever-lasting’ brands
Sanofi to Become a Top Player in the €113bn OTC Market(1)
Reinforces ambition to be a diversified global healthcare
leader focused on human health
8. A Value Creating Transaction Based on Strong Financials
● Combined CHC global sales
of around €4.9bn in 2015(1)
● Focus on a portfolio of
high-value self medications
(1) Excludes Boehringer Ingelheim CHC in China; value of CHC sales in Venezuela have been reduced to nearly zero due to revision of foreign
exchange rates by both companies
● Synergies in advertising and
promotional activities
● Global commercial platform
for OTC launches and Rx
switches
● BOI margin contribution
expected to be around 30%
in 2018
● Expect transaction to be
business EPS neutral in 2017
and accretive in subsequent
years
BI Consumer Healthcare €6.7bn plus
gross cash payment €4.7bn
Sanofi Animal Health €11.4bn
8
Financial implications
Increased Scale in
CHC Business
Value creation
9. 9
BI Transaction Increases Scale of Sanofi CHC Portfolio in
Attractive Categories and Important Geographies
● Highly complementary portfolio
boosts market position in priority
categories
● 6 iconic brands generate 60% of
BI CHC sales in 2015
● BI footprint complementary in
strategically important countries(2)
● Japan (€299m), U.S. (€186m) and
Germany (€162m)
(1) Nicholas Hall & Company, MAT Q3 2016
(2) BI sales in 2015
Global
size in
€bn(1)
33.1 #5 #3
19.6 #10 #6
16.2 #5 #1
15.4 #4 #2
3.8 #3 #2
1.0 #1 #1
+
Market Rank(1,2)
Sanofi
Global Categories
/
12. 12
- Capturing Share in Key Markets
(1) IMS Rapid weekly as of December 21th, 2016
(2) Market Share of the Basal insulin market in International Units for France, Germany, Spain, UK and Japan, in TRx
for the U.S.;
Toujeo® Market Share(1,2)
Top EU Countries, Japan and the U.S.
● Toujeo® generated sales €411m YTD
September 2016
● 6.8% TRx market share in the U.S.(1)
● Launched in 35 countries
● U.S. formulary status remains favorable
● >3/4 commercial lives covered in 2017
● Solid performance in top EU countries
despite introduction of biosimilar glargine
● Strong rebound in Japan following the
lifting of the 2-week prescription limitation
in September 2016
0%
5%
10%
15%
20%
W0 W10 W20 W30 W40 W50 W60 W70 W80 W90
France Germany UK Spain Japan U.S.
Week since launch
13. 13
- Important Addition to our Diabetes Franchise
● U.S. FDA approval of Soliqua™ 100/33
● Once-daily fixed-ratio combination of Lantus® and
GLP-1 receptor agonist Adlyxin® (lixisenatide)
● Indicated for adults with type 2 diabetes
inadequately controlled on basal insulin
(less than 60 Units daily) or lixisenatide
● Administered with the SoloStar® pen device
● SOLIQUA™ 100/33 U.S. product profile
● Wide dosing range (15 to 60 units of insulin)
in a single pen
● Flexible switching regimen with recommended
starting dose of 15 or 30 units
● Positive CHMP opinion on SULIQUA™ in Nov 16;
EU regulatory decision anticipated in Jan 17
>50% of people with diabetes remain uncontrolled on basal insulin(1)
(1) Banegas JR, et al. Eur Heart J. 2011;32(17):2143-52, DOI: 10.1093/eurheartj/ehr080; Stark Casagrande S, et al. Diabetes Care. 2013;36(8):2271-9,
DOI: 10.2337/dc12-2258; Vouri SM, et al. J Manag Care Pharm. 2011;17(4):304-12, http://www.ncbi.nlm.nih.gov/pubmed/21534641
Launched in the U.S.
January 4, 2017
14. 14
Praluent® is developed and commercialized in collaboration with Regeneron
(1) Internal estimates
(2) IMS Health
● Sanofi and Regeneron will appeal the District Court’s rulings in the Federal
Circuit Court of Appeals, including requesting a stay of the injunction
during the pendency of the appeal
● Will vigorously defend our case through the appeal process as we believe
that Amgen’s asserted patent claims are invalid and the facts and
controlling law support our position
● Praluent® continues to be available to patients
● More than 18,000 patients in the U.S. treated(1)
● Approximately 85% of prescriptions are dispensed at the low 75mg dose(2)
● ODYSSEY OUTCOMES trial expected to complete in late 2017 as planned
● DMC will continue to monitor study
● Focused on patients with the highest medical need
- Litigation and Product Update
15. Re-submission for Regulatory Review in
the U.S. expected in Q1 2017
15
U.S. launch preparation activities ongoing
Sarilumab is developed in collaboration with Regeneron Pharmaceuticals, Inc.
Sarilumab is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority
(1) Subject to successful FDA prelicense inspection related to dupilumab
(2) Most frequently reported Treatment Emergent Adverse Events include serious infections, injection site erythema and neutropenia
(3) 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
● Based on review of responses to the FDA 483 as
well as proposed corrective actions, the FDA has
classified the Le Trait ‘fill and finish’ facility as
“acceptable”
● Expect FDA inspection of Le Trait and re-submission
of sarilumab BLA in Q1 2017(1)
● IL-6 plays key roles in the local joint symptoms and
systemic manifestations of rheumatoid arthritis (RA)
● Positive Phase 3 efficacy/safety data in
methotrexate-inadequate responder (IR) and
difficult-to-treat TNF-IR populations(2)
● Positive sarilumab monotherapy efficacy data
compared to Humira® monotherapy(3)
16. 16
First-in-Class Biologic for Adults with
Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
● Characterized by intense itching
and recurrent eczematous lesions
● Multifactorial etiology involving
immune-mediated inflammation,
genetic factors, and environmental
triggers
● Although it often starts in infancy,
it is also highly prevalent in adults
IGA 4 IGA 1
● BSA affected: 86.5%
● EASI score: 51.5
● Pruritus NRS: 7
● AD duration: 48 years
● BSA affected: 2.5%
● EASI score: 3.1
● Pruritus NRS: 1.6
BLA accepted for priority review by the FDA with PDUFA date of March 29, 2017
®
Pictures from Phase 3 clinical trial provided for illustration purposes only to show
how the clinical parameters above may correlate to the clinical presentation of a patient.(1)
Dupixent® is developed in collaboration with Regeneron Pharmaceuticals, Inc.
Dupixent® is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority
IGA: Investigator Global Assessment BSA: Body Surface Area EASI: Eczema Area and Severity Index NRS: Numerical Rating Scale
(1) Images are taken from one patient at baseline (left) and at 16 weeks (right). Results were not representative of all patients and individual results did
vary. In phase 3 clinical trials, the percentage of patients achieving an IGA score of 0 or 1 ranged from 36%-38%. Adverse events that were higher for
Dupixent® vs placebo included injection site reactions and conjunctivitis; Photo used with permission
17. Launch Focused on Patients with the
Highest Unmet Medical Need
17
Physician Focus
Target physicians
with experience
prescribing biologics
(i.e. Psoriasis)
Up to 7,000 doctors
in the U.S.
Patient Focus
Intolerant to or
inadequate response
to an existing therapy
(e.g. Topicals,
Oral/systemic steroids,
Immuno-suppressants)
Around 300,000
adult patients
in the U.S.
Dupixent® is developed in collaboration with Regeneron Pharmaceuticals, Inc.
Dupixent® is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority
®
18. 18
A Pipeline in One Product - Clinical Studies in Multiple
Indications Underway
Nasal polyposis
Phase 3 started in Q4 2016
Asthma
Phase 3 fully enrolled and U.S. submission
expected in Q4 2017
Atopic dermatitis (AD)
Phase 3, March 29 FDA PDUFA Date
Accepted for review by EMA in Dec 2016
Type 2, including Th-2 mediated diseases
DUPILUMAB
Eosinophilic esophagitis Ph 2 data exp. H2 17
Food allergy Phase 2 expected to start 2017
Additional
Indications
Pediatric expansion in AD(1) and Asthma
Ph 3 studies in AD (age 6-11 and 12-17) and
Asthma (age 6-11) expected to start Q1 2017
(1) FDA Breakthrough designation for adults and pediatric moderate to severe atopic dermatitis
19. 19
- Update on Launches in Endemic Countries
(1) Bolivia, Brazil, Cambodia, Costa Rica, El Salvador, Guatemala, Indonesia, Mexico, Paraguay, Peru, the Philippines, Thailand and Singapore
(2) http://www.who.int/wer/2016/wer9130.pdf?ua=1
● Dengvaxia® approved in 13 countries(1)
● License application filed in 31 endemic
countries including the U.S. FDA in Dec
2016
● ~750,000 people administered to date
● Sales of €50m in first 9 months of 2016
● Sales largely from Philippines and
Paraná state in Brazil
● Working on roll-out of immunization
program in other states of Brazil
WHO recommends vaccination in high disease burden geographies(2)
21. 21
Expanding Pipeline in Leadership Categories:
Diabetes and Rare Diseases
Sotagliflozin
● Dual SGLT1 and SGLT2
inhibitor(1)
● Limiting meal time glucose
absorption and increasing
renal glucose excretion
● Oral administration
● Favorable safety profile
● Positive Phase 3 data in
Type 1 diabetes announced
● Phase 3 program in Type 2
diabetes started in 2016
Olipudase alfa NeoGAA
● Rare genetic lysosomal
storage disorder:
Second-generation therapy
for Pompe disease
● NeoGAA(3) glycan structure
could potentially have
efficacy, safety and
convenience advantages
● First patient enrolled in
pivotal Phase 3 COMET
study in November 2016
● Rare genetic lysosomal
storage disorder:
Acid sphingomyelinase
deficiency, ASMD(2)
● FDA Breakthrough
Therapy designation
● Leveraging Sanofi
Genzyme’s strong
presence in hematology
● Pivotal Phase 2/3 trial
started in July 2016
(1) SGLT2 (sodium-glucose cotransporter type 2) is a transporter responsible for most of the glucose reabsorption performed by
the kidney; SGLT1 (sodium-glucose cotransporter type 1) is a transporter responsible for glucose and galactose absorption in
the gastrointestinal tract, and to a lesser extent than SGLT2, glucose reabsorption in the kidney
(2) Also known as Niemann-Pick Type B
(3) GAA: Genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase
22. 22
Re-Building a Competitive Position in Oncology
MoA: Mechanism of Action
(1) HDeckert, et al. Clin Cancer Res 2014;20:4574–83.
(2) ICARIA-MM: A phase 3 randomized, open-label, multicenter study comparing Isatuximab (SAR650984) in Combination with Pomalidomide And Low-
Dose Dexamethasone verRsus Pomalidomide and Low-Dose Dexamethasone In patients with refractory or relapsed and refractory Multiple Myeloma
Isatuximab
(anti-CD38)
● Pivotal Phase 2/3 study in cutaneous squamous cell carcinoma ongoing
● Phase 2 study in basal cell carcinoma expected to start in H1 2017
● Start of Phase 2 study in non-small cell lung cancer planned for H1 2017
PD-1
(REGN2810)
Sanofi’s Antibody Drug Conjugates (ADCs) in Phase 1 complementary
to our multi-specific antibody platform and IO strategy
● Product profile potentially differentiated
● Targets unique epitope with a distinct combination MoA(1)
● Phase 3 study in relapsed/refractory multiple myeloma initiated in December(2)
● Potential indications beyond multiple myeloma being explored