October 1st, 2016

IR THEMATIC CALL ON DUPILUMAB

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Sanofi Forward-Looking Statements

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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.

Regeneron Forward-Looking Statements

This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation dupilumab; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products, such as dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis; unforeseen safety issues and possible liability resulting from the administration of products and product candidates in patients, including without limitation dupilumab; serious complications or side effects in connection with the use of Regeneron's products and product candidates in clinical trials; coverage and reimbursement determinations by third-party payers, including Medicare, Medicaid, and pharmacy benefit management companies; ongoing regulatory obligations and oversight impacting Regeneron's marketed products, research and clinical programs, and business, including those relating to the enrollment, completion, and meeting of the relevant endpoints of post-approval studies; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates, such as dupilumab; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare LLC (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2015 and its Form 10-Q for the quarterly period ended June 30, 2016. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

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Agenda

Unmet Needs in Atopic Dermatitis

● Bill Sibold – Senior Vice President, Global Franchise Head, Multiple Sclerosis, Oncology and Immunology, Sanofi Genzyme

Results from SOLO 1 & SOLO 2 Phase 3 Studies

● Professor Michael Cork – Head of the Academic Unit of Dermatology Research Department of Infection and Immunity, The University of Sheffield, UK

Next Steps with Dupilumab

● Robert Terifay – Executive Vice President, Commercial, Regeneron

Q&A Session

Dupilumab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

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UNMET NEEDS IN ATOPIC DERMATITIS

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Bill Sibold

Senior Vice President, Global Franchise Head, Multiple Sclerosis, Oncology and Immunology, Sanofi Genzyme

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Atopic Dermatitis is Characterized by Chronic or Relapsing Inflamed Skin With Intractable Pruritus

Atopic Dermatitis (AD)

● Characterized by intense itching and recurrent eczematous lesions

● Multifactorial etiology involving immune-mediated inflammation, genetic factors, and environmental triggers

● High negative impact on quality of life

● Although it most often starts in infancy, it is also highly prevalent in adults

Image of actual patients at entry in dupilumab studies

(1) Simpson EL et al, J Am Acad Dermatol. 2016;74(3):491-498 (2) Elman S et al. Br J Dermatol. 2010;162(3):587-593. (3) Charman CR et al. Arch Dermatol. 2004;140(12):1513-1519. (4) Yang Y et al. Eur J Health Econ. 2015;16:927-939.

‡Assessed using EuroQol (EQ-5D).(4)

AD Sufferers Often Experience Severe, Persistent Itch

Characteristics and Consequences of Itch in Moderate-to-Severe AD (N = 380 patients)(1)

†Assessed using the Patient-oriented Eczema Measure (POEM).(3) *Assessed using the 5-D pruritus scale.(2)

Severe

Frequent

Long-lasting

Pain

Disrupted sleep

experienced severe or unbearable itching* 61%

86% reported daily itch symptoms†

63% reported itching at least 12 hours a day*

77% reported moderate or extreme pain or discomfort‡

4.4 per week, on average, were interrupted by itching† nights

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8

0

10

20

30

40

Prevalenceof fatigue

Regulardaytime

sleepiness

Insomnia

% o

f pat

ient

s

Adults with AD Adults without AD

14.3

12.2

8.8

10.3

9.9

Moderate-Severe AD

Atopic Eczema

Psoriasis

Pruritis

Chronic Urticaria

U.S. 2012 National Health Interview Survey(1)

AD has a large impact on patient quality of life

Itch leads to disturbed sleep

0

5

10

15

20

Symptoms ofdepression

Symptoms ofanxiety

% o

f pat

ient

s

Adults with AD Adults without AD

Observational cross-sectional study conducted in 13 EU countries(2)

Risk of depression and anxiety increases

Mean DLQI score*

Dermatology Life Quality Index: AD data observed from multinational

clinical study (N=380)

* DLQI score range of 0 to 30; higher scores indicate a greater impact (1) Silverberg JI et al, J Invest Dermatol. 2015;135(1):56-66 (2) Dalgard FJ et al, J Invest Dermatol. 2015 Apr;135(4):984-91 (3) Lewis V et al, J Investig Dermatol Symp Proc. 2004; 9:169-180 (4) Simpson EL et al, J Am Acad Dermatol. 2016;74(3):491-498

Atopic Dermatitis Impacts More Than Just The Skin Negative Impact of AD on Quality of Life and Mental Health Is Underestimated

(3)

(3)

(3)

(4)

(3)

There Remains an Unmet Need For Safe And Effective Treatment Options For Patients With Moderate-to-Severe AD

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(1) Akdis CA et al. Allergy. 2006;61:969-987 (2) Guidelines by the Practical Consensus Group EAACI+AAAAI. Japanese guidelines relatively similar (3) Grundmann SA et al, J Allergy (Cairo). 2012;2012:121797, (4) Akhavan A et al. Semin Cutan Med Surg. 2008;27:151-155 (5) Eichenfield LF at al. J Am Dermatol. 2014;71:116-132

Current AD Treatment Algorithm(2)

Antibiotic therapy used on frequent basis with recurrent infections (most Staph. Aureus) TCS – Topical Corticosteroids TCI – Topical Calcineurin inhibitors Systemic therapy include oral corticosteroids and immunosuppressants (mostly used off-label, with the exception of cyclosporine, which is licensed for short-term treatment of severe refractory AD in European countries).

Emollients, skin hydratation

Low-mid potency TCS and/or TCI + Basic treatment

Mid-high potency TCS/TCI + Basic treatment

Systemic or UV therapy + Mid-high potency TCS/TCI

+ Basic treatment

antih

ista

min

es

mild

m

oder

ate

seve

re ● Phototherapy (UV): Inconvenient and not

available for all patients(3)

Limitations of Currently Available Therapies

● Immunosuppressants: Long-term use associated with significant toxicities, e.g. kidney & liver toxicity, potentially impacting use(4)

● Topical corticosteroids (TCS): Long-term use can cause irreversible skin atrophic changes, and may lead to adrenal suppression(5)

Treatment guidelines recommend increasing intensity of therapy as disease severity advances(1)

32%

11%

21%

12%

17%

6%

13%

9%

5%

Manage pruritus

Reduce severity of flares

Achieve long term control

Reduce frequency of flares

Reduce redness of lesions

Reduce duration of flares

Limit psychological impact

Manage pain / soreness

Reduce thickness of lesions

Reduce sleep disruption due to AD

Needs or Treatment Goals Rated by Order of Importance by Severe AD Patients (N=97)(1)

(1) Source: Adelphi – Atopic Dermatitis Disease Specific Program, US 2014.

● Over 30% of patients with severe AD report managing pruritus (itch) as most important treatment goal

● Reduction of flare severity / lesion severity often comes second

● Greater emphasis on long-term control with favorable safety for severe patients

Symptom Improvements and Long-term Disease Control Are Key in AD Patients’ Needs and Treatment Goals

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Reduce frequency of flares

Reduce redness of lesions

Reduce duration of flares

Limit psychological impact

Manage pain / soreness

Reduce thickness of lesions

Reduce sleep disruption due to AD

Most important 2nd most important 3rd most important

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A Broad Phase 3 Program in Adults With Moderate-to-Severe AD

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SOLO 1 Treatment period of 16 weeks

Patients inadequately controlled with or

inadvisable for topical medications

671

SOLO 2 708

SOLO-CONTINUE

Treatment period of 36 weeks after completion of

SOLO 1 or 2

Patients who achieved IGA 0-1 or EASI-75 at

week 16 in SOLO 1 or 2 475 On-going

CHRONOS Treatment period of up to 52 weeks (endpoints at 16

and 52 weeks)

Patients inadequately controlled with topical

medications 740

CAFÉ Treatment period of 16 weeks

Severe patients only Uncontrolled or ineligible

to oral CSA(2) 330 On-going

OLE

Open label extension for up to 3 years allowing use

of topical therapy as needed

Patients who participated to previous

studies 2600

On-going

Monotherapy

1

Concomitant administration

with TCS

2

Study Design(1) Population N Status

Open label extension

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TCS – Topical Corticosteroids IGA – Investigator Global Assessment CSA – Cyclosporine A EASI – Eczema Area and Severity Index (1) All studies are randomized, double-blind, and placebo-controlled, except OLE (2) In patients with severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when this treatment is currently not medically advisable. Study conducted in EU countries and in the Russian Federation.

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RESULTS FROM SOLO 1 & SOLO 2 PHASE 3 STUDIES

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Professor Michael Cork

Head of the Academic Unit of Dermatology Research Department of Infection and Immunity The University of Sheffield, UK

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DUPILUMAB IN MODERATE-TO-SEVERE ATOPIC DERMATITIS: RESULTS FROM TWO

RANDOMIZED PHASE 3 TRIALS (SOLO 1 & 2)

Eric L. Simpson, Thomas Bieber, Emma Guttman-Yassky, Lisa A. Beck, Andrew Blauvelt, Michael J. Cork, Jonathan I. Silverberg, Mette Deleuran,

Yoko Kataoka, Jean-Philippe Lacour, Külli Kingo, Margitta Worm, Yves Poulin, Andreas Wollenberg, Yuhwen Soo, Neil M.H. Graham, Gianluca Pirozzi,

Bolanle Akinlade, Heribert Staudinger, Vera Mastey, Laurent Eckert, Abhijit Gadkari, Neil Stahl, George D. Yancopoulos, Marius Ardeleanu

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Slides presented at late-breaker session at EADV Congress, 2016.

Pre- And Post-Treatment: Patient Treated With Dupilumab 300 mg Weekly

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IGA, Investigator Global Assessment; BSA, Body Surface Area; EASI, Eczema Area and Severity Index; NRS, Numerical Rating Scale.

Baseline Week 16

Week 16: • IGA score: 1 • BSA affected: 2.5% • EASI score: 3.1 • Pruritus NRS: 1.6

Baseline: • IGA score: 4 • BSA affected: 86.5% • EASI score: 51.5 • Pruritus NRS: 7 • AD duration: 48 years

Example of a patient who achieved IGA 1 in the clinical trial and is not representative of all patients. Individual results did vary. Photo used with permission.

Dupilumab: An Investigational IL-4/IL-13 Monoclonal Antibody Targeting Type 2/Th2 Pathway

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γc, common gamma chain; IL, interleukin; IL-4Rα, IL-4 receptor alpha; IL-13Rα, IL-13 receptor alpha; JAK, Janus kinase; STAT, signal transducer and activator of transcription; TYK2, tyrosine kinase type 2.

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• IL-4 and IL-13 are type 2/Th2 cytokines that are thought to mediate many features of AD

• Dupilumab is a fully human monoclonal antibody directed against the IL-4Rα subunit of the IL-4 and IL-13 receptors

IL-4Rα IL-4Rα γc IL-13Rα1

Type I receptor B cells, T cells, monocytes,

eosinophils, fibroblasts

Type II receptor Epithelial cells,

smooth muscle cells, fibroblasts, monocytes, activated B cells

IL-4 IL-13

• Dupilumab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Dupilumab

• Objective: Assess efficacy and safety of dupilumab monotherapy vs placebo in adults with moderate-to-severe AD inadequately controlled with or medically inadvisable for topical therapy

• 671 patients in SOLO 1 and 708 patients in SOLO 2

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SOLO 1 & SOLO 2: Pivotal Phase 3 Studies With Identical Study Design

* Dupilumab, 600 mg; placebo, matching placebo. q2w, every other week; qw, weekly; R, randomization; SC, subcutaneously.

Placebo SC qw

Dupilumab 300 mg SC qw

Post-treatment options: • Maintenance study • Open-label

extension

• Safety follow-up through Week 28

Screening Dupilumab 300 mg SC q2w

Treatment period (16 weeks)

Follow-up period (12 weeks)

Loading dose on Day 1*

Day –35 to –1 Baseline Week 28 Week 16

R

Baseline Disease Characteristics

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SOLO 1 SOLO 2

Event Placebo

qw (n = 224)

Dupilumab 300 mg

q2w (n = 224)

Dupilumab 300 mg

qw (n = 223)

Placebo qw

(n = 236)

Dupilumab 300 mg

q2w (n = 233)

Dupilumab 300 mg

qw (n = 239)

Duration of AD, median, years 28.0 26.0 26.0 26.0 24.5 24.0

BSA affected, median, % 57.0 53.4 54.5 53.3 50.0 50.0

EASI score, median 31.8 30.4 29.8 30.5 28.6 29.0

IGA score (range 0–4), %

3 (moderate) 50.4 51.8 52.5 51.3 50.6 53.1

4 (severe) 49.1 48.2 47.5 48.7 49.4 46.9

Peak pruritus NRS, median 7.7 7.6 7.7 7.7 7.8 7.8

Total SCORAD score, median 67.0 65.1 65.9 68.9 67.8 67.4

DLQI score, median 14.0 13.0 14.0 15.0 15.0 16.0

BSA, body surface area; DLQI, Dermatology Life Quality Index; NRS, numerical rating scale; SCORAD, SCORing Atopic Dermatitis.

Co-Primary Endpoints: IGA 0 or 1 And EASI-75 Response

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† Co-primary endpoint in EU and Japan; key secondary endpoint in other regions.

14.7 11.9

51.3

44.2

52.5 48.1

0

10

20

30

40

50

60

70

80

SOLO 1 SOLO 2

10.3 8.5

37.9 36.1 37.2 36.4

0

10

20

30

40

50

60

70

80

SOLO 1 SOLO 2

* * * *

* * * *

* P < 0.0001 vs placebo * P < 0.0001 vs placebo

EASI-75† at Week 16 IGA = 0 or 1 and ≥ 2 points reduction from baseline at Week 16

Patie

nts

(%)

Dupilumab 300 mg qw Dupilumab 300 mg q2w Placebo qw

Pre- And Post-Treatment: Patient Treated With Dupilumab 300 mg Weekly

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IGA, Investigator Global Assessment; BSA, Body Surface Area; EASI, Eczema Area and Severity Index; NRS, Numerical Rating Scale.

Baseline Week 16

Week 16: • IGA score: 1 • BSA affected: 2.5% • EASI score: 3.1 • Pruritus NRS: 1.6

Baseline: • IGA score: 4 • BSA affected: 86.5% • EASI score: 51.5 • Pruritus NRS: 7 • AD duration: 48 years

Example of a patient who achieved IGA 1 in the clinical trial and is not representative of all patients. Individual results did vary. Photo used with permission.

EASI: % Change From Baseline

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LS, least squares; SE, standard error.

-80

-70

-60

-50

-40

-30

-20

-10

00 1 2 4 6 8 12 16

-80

-70

-60

-50

-40

-30

-20

-10

00 1 2 4 6 8 12 16

−37.6

−30.9

−72.3*

−67.1*

−72.0*

−69.1*

* P < 0.0001 vs placebo * P < 0.0001 vs placebo

SOLO 1 SOLO 2

LS m

ean

perc

ent c

hang

e

in E

ASI f

rom

bas

elin

e (±

SE)

Week Week

Dupilumab 300 mg qw (censored) Dupilumab 300 mg q2w (censored) Placebo qw (censored)

Censored analysis categorized patients who received rescue treatment as missing data from the time of rescue, missing data were imputed by multiple imputation.

Peak Pruritus NRS: % Change From Baseline

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NRS, numerical rating scale.

-80

-70

-60

-50

-40

-30

-20

-10

00 2 4 6 8 10 12 14 16

-80

-70

-60

-50

-40

-30

-20

-10

00 2 4 6 8 10 12 14 16

*

−15.4

−44.3*

−48.3*

*

* P < 0.0001 vs placebo * P < 0.0001 vs placebo

SOLO 1 SOLO 2

LS m

ean

perc

ent c

hang

e in

pe

ak p

rurit

us N

RS

from

bas

elin

e (±

SE)

Week Week

Dupilumab 300 mg qw (censored) Dupilumab 300 mg q2w (censored) Placebo qw (censored)

−26.1

−51.0*

−48.9*

*

*

Censored analysis categorized patients who received rescue treatment as missing data from the time of rescue, missing data were imputed by multiple imputation.

DLQI And POEM: Proportions of Patients Achieving Improvement ≥ 4 (MCID) From Baseline at Week 16

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DLQI, Dermatology Life Quality Index; MCID, minimal clinically important difference; POEM, Patient-Oriented Eczema Measure.

30.5 27.6

64.1

73.1

58.4 62.0

0

10

20

30

40

50

60

70

80

SOLO 1 SOLO 2

26.9 24.4

67.6 71.7

63.1 64.0

0

10

20

30

40

50

60

70

80

SOLO 1 SOLO 2

*

* * *

* Nominal P < 0.0001 vs placebo * Nominal P < 0.0001 vs placebo *

* * *

DLQI POEM

Patie

nts

(%)

Dupilumab 300 mg qw Dupilumab 300 mg q2w Placebo qw

HADS-A (Anxiety) And HADS-D (Depression): Proportions of Patients Achieving Score < 8 at Week 16

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1. Bjelland I, et al. J Psychosom Res. 2002;52:69-77. HADS, Hospital Anxiety and Depression Scale; HADS-A, HADS Anxiety subscale; HADS-D, HADS Depression subscale.

Dupilumab 300 mg qw Dupilumab 300 mg q2w Placebo qw

12.4

6.1

41.0 39.5 36.3

41.2

0

10

20

30

40

50

60

70

80

SOLO 1 SOLO 2

* Nominal P < 0.0001 vs placebo † Nominal P = 0.0001 vs placebo

* † * *

Patie

nts

(%)

• Analysis conducted in patients with clinical symptoms of anxiety or depression at baseline (i.e., HADS-A or HADS-D ≥ 8)1

Adverse Events

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SOLO 1 SOLO 2

Event Placebo

qw (n = 222)

Dupilumab 300 mg

q2w (n = 229)

Dupilumab 300 mg

qw (n = 218)

Placebo qw

(n = 234)

Dupilumab 300 mg

q2w (n = 236)

Dupilumab 300 mg

qw (n = 237)

Patients, n (%)

≥ 1 AE 145 (65) 167 (73) 150 (69) 168 (72) 154 (65) 157 (66)

≥ 1 SAE 11 (5) 7 (3) 2 (1) 13 (6) 4 (2) 8 (3)

Death 0 0 0 0 1 (< 1) 1 (< 1) AEs leading to treatment discontinuation 2 (1) 4 (2) 4 (2) 5 (2) 2 (1) 3 (1)

Infections and infestations* 63 (28) 80 (35) 74 (34) 76 (33) 65 (28) 68 (29) Skin infections (adjudicated) 18 (8) 13 (6) 14 (6) 26 (11) 14 (6) 15 (6)

Non-skin infections 49 (22) 69 (30) 67 (31) 57 (24) 58 (25) 61 (26)

Herpes viral infections† 9 (4) 15 (7) 9 (4) 8 (3) 10 (4) 12 (5) * MedDRA System Organ Class. † MedDRA High Level Term. AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious AE.

Adverse Events Reported in ≥ 5% of Patients in Any Treatment Group

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SOLO 1 SOLO 2

Event* Placebo

qw (n = 222)

Dupilumab 300 mg

q2w (n = 229)

Dupilumab 300 mg

qw (n = 218)

Placebo qw

(n = 234)

Dupilumab 300 mg

q2w (n = 236)

Dupilumab 300 mg

qw (n = 237)

Patients, n (%)

Nasopharyngitis 17 (8) 22 (10) 25 (12) 22 (9) 20 (9) 20 (8)

Conjunctivitis 2 (1) 11 (5) 7 (3) 1 (< 1) 9 (4) 9 (4) Upper respiratory tract infection 5 (2) 6 (3) 11 (5) 5 (2) 7 (3) 9 (4)

Injection-site reaction 13 (6) 19 (8) 41 (19) 15 (6) 32 (14) 31 (13)

Atopic dermatitis 67 (30) 30 (13) 21 (10) 81 (35) 32 (14) 38 (16)

Headache 13 (6) 21 (9) 11 (5) 11 (5) 19 (8) 22 (9)

Allergic conjunctivitis 2 (1) 12 (5) 7 (3) 2 (1) 2 (1) 3 (1)

* MedDRA Preferred Term.

Conclusions

• In the pivotal phase 3 studies the primary endpoints were met

• Both dose regimens of dupilumab showed clinically meaningful improvement and statistical significance versus placebo in:

– AD signs and symptoms (including itch/pruritus and sleep) – Health-related quality of life – Symptoms of anxiety/depression

• Significant improvement in itch was observed as early as Week 2

• Most AEs were mild or moderate – Injection site reactions and conjunctivitis were more frequent with dupilumab – Overall, there were no observed increases in infections with dupilumab

• Dual targeting of IL-4 and IL-13 represents a potential therapeutic option in adults with moderate-to-severe AD

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Dupilumab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

NEXT STEPS WITH DUPILUMAB

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Robert Terifay

Executive Vice President, Commercial, Regeneron

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Uncontrolled Moderate-to-Severe Atopic Dermatitis Represents a Significant Unmet Need in Adults

28

Those who have failed topical and eligible for systemic therapy

1

Those who have failed oral/systemic steroids

2

3

These patients face substantial burden of disease and may need new treatment options

At Launch, Focus on

Patient Groups with

Greatest Need

28

Those who have failed and/or are intolerant to immunosuppressant therapy

Regulatory Milestones and Next Development Steps in AD

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The European Medicines Agency (EMA) and FDA have conditionally accepted Dupixent® as the trade name for dupilumab. TCS – Topical corticosteroids BLA – Biological license application

● Positive Phase 3 data when administered in monotherapy (SOLO 1, SOLO 2) and concomitantly with TCS (CHRONOS) ● Clinically meaningful and significant improvements in skin clearing (IGA

scores) disease severity (EASI scores) and symptoms (pruritus NRS)

● Favorable safety profile ● Most common adverse events in the dupilumab groups, compared to placebo,

were injection site reactions and conjunctivitis

● Designation as Breakthrough Therapy in adult AD indication in the U.S. and as Promising Innovative Medicine in the UK

● BLA accepted for priority review by the FDA with an action date of March 29, 2017

● EU and Japan submission expected in Q4 2016

● CONTINUE and CAFÉ studies ongoing

● Phase 3 pediatric studies in AD and in asthma to begin in 2017

DUPIXENT®

● Pivotal Study expected to start in 1Q 2017 ● 16-week trial + 12-week follow up

Dupilumab Phase 3 Development in Pediatric AD Will be by Successive Age Groups

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● Pivotal Study expected to start in H1 2017 ● 16-week trial + 12-week follow up

● Pivotal Study expected to start in 2018 ● 16-week trial + 12-week follow up

Adolescents 12-17 years

6-11 years

6 months to 5 years

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Dupilumab: Clinical Studies in Multiple Indications

Nasal polyposis Phase 3 to start in Q1 2017 Eosinophilic esophagitis Phase 2 ongoing

Asthma Phase 3 fully enrolled

Atopic dermatitis Phase 3, March 29 FDA Action Date

Additional Indications

Type 2, including Th2-mediated diseases

DUPILUMAB

32

LIBERTY ASTHMA Program: Key Dupilumab Studies Underway

QUEST (pivotal Phase 3) TRAVERSE VENTURE

Trial Description

Adult and adolescent (>12 years) patients with persistent asthma inadequately controlled by ICS + second controller

Long-term safety/tolerability in severe uncontrolled asthmatic patients who participated to previous dupilumab studies

Evaluating reduction in use of OCS in adult and adolescent patients (>12 years) with severe steroid-dependent asthma

Target N 1638 2082 150

Length of Trial

69 wks (5-wk screening + 52-wk treatment + 12-wk follow-up)

112 wks (96-wk treatment + 12-wk follow-up)

46 wks (10-wk screening + 24-wk treatment + 12-wk follow-up)

Active Treatment Arms

• Loading Dose (400 mg) + 200 mg Q2W

• Loading Dose (600 mg) + 300 mg Q2W

• Loading Dose (400 mg) + 200 mg Q2W

• Loading Dose (600 mg) + 300 mg Q2W

• Loading Dose (600 mg) + 300 mg Q2W

Primary Endpoint

Severe exacerbation events over 52 weeks and FEV1 change at week 12

Number of AEs at week 112 Change in OCS dose at week 24

Fully enrolled

OCS – oral corticosteroids FEV1 – Forced expiratory volume in one second AEs – Adverse events sBLA – supplemental BLA sBLA in asthma indication will include results from Phase 2b study and LIBERTY ASTHMA QUEST

2nd sBLA Filing in Asthma Initial sBLA Filing

Nasal Polyps and Eosinophilic Esophagitis Clinical Studies Progressing

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Nasal Polyps (NP) Eosinophilic Esophagitis (EoE)

(1) Bachert C et al, JAMA 2016;315(5):469-79 (The study included 60 adults with chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids)

NP is a disease characterized by symptoms related to inflammation of the upper airways with obstruction of the sinus and nasal passages ● Positive Phase 2 trial reported(1) ● Phase 3 study expected to

begin in early 2017

EoE is a chronic disease characterized by symptoms related to esophageal dysfunction and eosinophilic-predominant inflammation ● Proof-of-concept, Phase 2 trial

underway

Preparing For Launch in Atopic Dermatitis

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● Sustained efficacy confirmed in Phase 3 studies completed in atopic dermatitis

● Unique mechanism of action; potentially the first monoclonal antibody to launch in atopic dermatitis

● Sanofi’s Specialty Care Business Unit (Sanofi Genzyme) and Regeneron preparing for launch

● Sanofi and Regeneron to co-promote in the U.S.

● Major presence at congresses, including EADV

● Comprehensive patient support program

Q&A SESSION

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