SlideShare une entreprise Scribd logo
1  sur  15
Télécharger pour lire hors ligne
1
DUPIXENT® FDA Approval Call
March 28, 2017
2
Sanofi 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, Sanofi’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, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
3
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 Dupixent® (dupilumab)
Injection; 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 Dupixent for the treatment of uncontrolled moderate-to-severe atopic dermatitis in jurisdictions outside
the United States and other potential indications; unforeseen safety issues and possible liability resulting from the administration of products and product
candidates in patients, including without limitation Dupixent; serious complications or side effects in connection with the use of Regeneron's products
and product candidates (such as Dupixent) 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 Dupixent; 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, Bayer, and Teva Pharmaceutical Industries Ltd. (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, including without limitation the patent litigation relating to Praluent® (alirocumab) Injection, the
permanent injunction granted by the United States District Court for the District of Delaware that, if upheld on appeal, would prohibit Regeneron and
Sanofi from marketing, selling, or manufacturing Praluent in the United States, the outcome of any appeals regarding such injunction, the ultimate
outcome of such litigation, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition.
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, 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.
4
Agenda
Opening remarks – DUPIXENT®, a breakthrough innovation
● Olivier Brandicourt – Chief Executive Officer, Sanofi
● Leonard S. Schleifer, MD, PhD – Founder, President and Chief Executive Officer, Regeneron
Q&A Session
● George D. Yancopoulos, MD, PhD – Founding Scientist, President and Chief Scientific Officer,
Regeneron
● Elias Zerhouni, MD – President, Global Research & Development, Sanofi
● Bill Sibold – Global Head Multiple Sclerosis, Oncology & Immunology, Sanofi Genzyme
● Robert Terifay – Executive Vice President, Commercial, Regeneron
5
DUPIXENT®: A Breakthrough Treatment for Moderate-to-
Severe Atopic Dermatitis (AD)
● A key new product launch for
Regeneron and Sanofi
● Important addition to Sanofi Genzyme
specialty care business
● Science driving innovation:
First biologic therapy for AD
approved in the US
● Excited to bring product rapidly to
market to help address high unmet need
● Kevzara™ (sarilumab) BLA resubmitted
6
Il-4/IL-13 Considered Common Drivers in the Following
Diseases(1)
Il-4/IL-13 signaling is
considered to be
central to many Type-2
mediated allergic
diseases
IL-4/
IL-13
Atopic
Dermatitis
Asthma
Nasal
Polyps
Eosinophilic
Esophagitis
(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
7
● Moderate-to-severe form of AD can be a debilitating, life-altering condition that impacts
people’s day-to-day functioning
● Characterized by intense itching and recurrent eczematous lesions
● Multifactorial etiology involving immune-mediated inflammation, skin-barrier defect, genetic
factors and environmental triggers
● Although it often starts in infancy, it is also prevalent in adults
AD is a Chronic, Inflammatory Skin Disease,
Characterized by Intractable Pruritus
8
DUPIXENT®: The First FDA Approved Biologic for Adults
with Uncontrolled Moderate-to-Severe AD
DUPIXENT® INDICATIONS AND USAGE
DUPIXENT® is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis
whose disease is not adequately controlled with topical prescription therapies or when those therapies
are not advisable. DUPIXENT® can be used with or without topical corticosteroids.
DUPIXENT® WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions, including generalized urticaria and serum sickness or
serum sickness-like reactions, were reported in subjects who received DUPIXENT®. If a systemic
hypersensitivity reaction occurs, discontinue DUPIXENT® immediately and initiate appropriate therapy.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in subjects who
received DUPIXENT®. Conjunctivitis was the most frequently reported eye disorder. Patients should
report new onset or worsening eye symptoms to their healthcare provider.
Comorbid Asthma: Safety and efficacy of DUPIXENT® have not been established in the treatment of
asthma. Advise patients with comorbid asthma not to adjust or stop their asthma treatment without
consultation with their physicians.
Parasitic (Helminth) Infections: Patients with known helminth infections were excluded from
participation in clinical studies. It is unknown if DUPIXENT® will influence the immune response against
helminth infections
9
U.S. Launch Focused on Patients with the Highest Unmet
Medical Need
Patient
Focus at Launch
Moderate-to-severe AD
patients intolerant to or
inadequate response
to an existing therapy
(Topical prescription therapies and
Oral/systemic steroids or
Immuno-suppressants)
Around 300,000
adult patients
in the U.S.
● 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
Pictures from Phase 3 clinical trial provided for illustrative purposes
only to show how the clinical parameters above may correlate to the
clinical presentation of a patient.(1,2)
(1) Images are taken from same 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%.
(2) The most common side effects in clinical trials included injection site
reactions, eye and eyelid inflammation, including redness, swelling and
itching, and cold sores in mouth or on lips
IGA: Investigator Global Assessment
BSA: Body Surface Area
EASI: Eczema Area and Severity Index
NRS: Numerical Rating Scale
IGA 4 IGA 1
10
Target Physicians who Treat AD Patients and
Have Experience Prescribing Biologics
Physician
Focus at Launch
Dermatologists
(i.e. Psoriasis)
Allergists/Immunologists
Up to 7,000 doctors
in the U.S.
11
A Commitment to Responsible Pricing: Valuing a
Breakthrough Therapy for Moderate-to-Severe AD
Breakthrough,
First-in-Class Therapy
Disease Burden/Treatment
Landscape
Cost-Effectiveness
Analyses
Physician, Patient, Payer & Other
Stakeholder Feedback
Ensuring Continued
Investment in Biopharma
Innovation
RESPONSIBLE
PRICING FOR
DUPIXENT®
Clinical &
QoL Benefit
QoL: Quality of Life
Careful consideration of several clinical and economic value
measures in pricing DUPIXENT®
Qualitative measures
Quantitative measures
Comparable Biologic
Pricing
12
WAC = Wholesale Acquisition Cost
(1) Moderate-to-severe AD compared with moderate to severe psoriasis. As measured by the Dermatology Life Quality Index (DLQI) , a scale where a higher number means a
worse impact on quality of life. DLQI data derived from 11 published clinical studies of psoriasis treatments in patients with moderate to severe psoriasis, data on file.
Moderate-to-severe AD DLQI data derived from Phase 3 SOLO 1 and SOLO 2 studies clinical studies report, data on file.
(2) Yearly maintenance treatment cost based on WAC prices in the U.S. (not reflective of discounts or rebates) and excludes one-time loading dose(s).
(3) Annual treatment costs for Dupixent in AD compare favorably with biologic treatments for psoriasis including adalimumab, etanercept, ixekizumab, secukinumab and
ustekinumab. The chart represents a comparison of list prices and is not intended to imply a comparison of safety or efficacy.
DUPIXENT® WAC is Lower than Biologics Used to Treat
Psoriasis(1)
0
5
10
15
20
25
30
BaselineMeanDLQIScore
11.5 - 13
Moderate-to-Severe
Atopic Dermatitis
14.5 - 16
Moderate-to-Severe
Psoriasis
Humira
Enbrel
Stelara
Dupixent
Psoriasis Biologic
Treatments
AD is at Least as Burdensome a
Disease as Psoriasis(1)
Yet DUPIXENT® WAC is
Lower than Psoriasis Biologics(2,3)
(in USD)
$30,000
$80,000
$70,000
$50,000
$10,000
$60,000
$40,000
$90,000
$20,000
$0
~$41,000
~$83,000
$37,000
13
Working Alongside Payers to Provide Appropriate Access
For Patients
Provide Patient Access
● Consultation with PBMs
Aligned view on the burden of disease, the
unmet need that exists and the right patient
for treatment
● Early Formulary Coverage Expected(1)
for a large population of patients within days
● Appropriate Utilization Management
Criteria
Expect physician attestation, specialist-only
prescription, and no step-edits through
systemic immunosuppressant therapies
Payer Discussions
(1) Individual plans may vary
14
Comprehensive Support to Optimize Patient Access and
Minimize Barriers to Treatment
Patient Support & Coverage Patient Access
● $0 Copay
Program for
eligible patients
● Patient
Assistance
Program
● Education and personalized
nurse support
● Benefits Investigation
● Prior Authorization
Assistance
● Appeals
Support
DUPIXENT® expected to be commercially available in the U.S. later this week
15
Q&A

Contenu connexe

Tendances

Drug promotional literature
Drug promotional literature Drug promotional literature
Drug promotional literature Akhil Agarwal
 
2020 - Vitamin D- CME - E.pptx
2020 - Vitamin D- CME - E.pptx2020 - Vitamin D- CME - E.pptx
2020 - Vitamin D- CME - E.pptxDrRavikumarRyakha
 
Edrumox - Moxifloxacin, Presentation.pdf
Edrumox - Moxifloxacin, Presentation.pdfEdrumox - Moxifloxacin, Presentation.pdf
Edrumox - Moxifloxacin, Presentation.pdfMagferat
 
Newer insulins in clinical practice
Newer insulins in clinical practiceNewer insulins in clinical practice
Newer insulins in clinical practiceDr. Arun Sharma, MD
 
Biologic Therapy
Biologic TherapyBiologic Therapy
Biologic Therapydrmomusa
 
10 Step Marketing Plan for Lamisil by TanJM
10 Step Marketing Plan for Lamisil by TanJM10 Step Marketing Plan for Lamisil by TanJM
10 Step Marketing Plan for Lamisil by TanJMreachjoemar
 
Brand Plan for the launch of Brand-X
Brand Plan for the launch of Brand-XBrand Plan for the launch of Brand-X
Brand Plan for the launch of Brand-XSatyajit Hui
 
Improving & Understanding Antibiotic Prescription During Pregnancy
Improving & Understanding Antibiotic Prescription During PregnancyImproving & Understanding Antibiotic Prescription During Pregnancy
Improving & Understanding Antibiotic Prescription During PregnancyMamdouh Sabry
 
Pharmacotherapy of Chronic Obstructive Pulmonary Disease (COPD)
Pharmacotherapy of Chronic Obstructive Pulmonary Disease (COPD)Pharmacotherapy of Chronic Obstructive Pulmonary Disease (COPD)
Pharmacotherapy of Chronic Obstructive Pulmonary Disease (COPD)Arvind Kumar
 
Gout Pharmacotherapy
Gout PharmacotherapyGout Pharmacotherapy
Gout PharmacotherapyJagirPatel3
 
Newer anti diabetic drugs
Newer anti diabetic drugsNewer anti diabetic drugs
Newer anti diabetic drugsDr.Vijay Talla
 

Tendances (20)

Drug promotional literature
Drug promotional literature Drug promotional literature
Drug promotional literature
 
2020 - Vitamin D- CME - E.pptx
2020 - Vitamin D- CME - E.pptx2020 - Vitamin D- CME - E.pptx
2020 - Vitamin D- CME - E.pptx
 
Antiviral Drugs
Antiviral DrugsAntiviral Drugs
Antiviral Drugs
 
Edrumox - Moxifloxacin, Presentation.pdf
Edrumox - Moxifloxacin, Presentation.pdfEdrumox - Moxifloxacin, Presentation.pdf
Edrumox - Moxifloxacin, Presentation.pdf
 
Cephalosporins
CephalosporinsCephalosporins
Cephalosporins
 
Dpp 4 inhibitors
Dpp 4 inhibitorsDpp 4 inhibitors
Dpp 4 inhibitors
 
Newer insulins in clinical practice
Newer insulins in clinical practiceNewer insulins in clinical practice
Newer insulins in clinical practice
 
Leg en el embarazo y neonatal
Leg en el embarazo y neonatal Leg en el embarazo y neonatal
Leg en el embarazo y neonatal
 
NOVARTIS
NOVARTIS NOVARTIS
NOVARTIS
 
Biologic Therapy
Biologic TherapyBiologic Therapy
Biologic Therapy
 
10 Step Marketing Plan for Lamisil by TanJM
10 Step Marketing Plan for Lamisil by TanJM10 Step Marketing Plan for Lamisil by TanJM
10 Step Marketing Plan for Lamisil by TanJM
 
Brand Plan for the launch of Brand-X
Brand Plan for the launch of Brand-XBrand Plan for the launch of Brand-X
Brand Plan for the launch of Brand-X
 
Improving & Understanding Antibiotic Prescription During Pregnancy
Improving & Understanding Antibiotic Prescription During PregnancyImproving & Understanding Antibiotic Prescription During Pregnancy
Improving & Understanding Antibiotic Prescription During Pregnancy
 
Pharmacotherapy of Chronic Obstructive Pulmonary Disease (COPD)
Pharmacotherapy of Chronic Obstructive Pulmonary Disease (COPD)Pharmacotherapy of Chronic Obstructive Pulmonary Disease (COPD)
Pharmacotherapy of Chronic Obstructive Pulmonary Disease (COPD)
 
Omalizumab (Xolair)
Omalizumab (Xolair)Omalizumab (Xolair)
Omalizumab (Xolair)
 
Azathioprine
AzathioprineAzathioprine
Azathioprine
 
Gout Pharmacotherapy
Gout PharmacotherapyGout Pharmacotherapy
Gout Pharmacotherapy
 
Thalidomide
ThalidomideThalidomide
Thalidomide
 
Fluoroquinolones
FluoroquinolonesFluoroquinolones
Fluoroquinolones
 
Newer anti diabetic drugs
Newer anti diabetic drugsNewer anti diabetic drugs
Newer anti diabetic drugs
 

Similaire à 2017/03 – IR call - Dupixent®

2015/11 - IR - Sarilumab
2015/11 - IR - Sarilumab2015/11 - IR - Sarilumab
2015/11 - IR - SarilumabSanofi
 
2018/03 – IR Call – Odyssey Outcomes
2018/03 – IR Call – Odyssey Outcomes2018/03 – IR Call – Odyssey Outcomes
2018/03 – IR Call – Odyssey OutcomesSanofi
 
2015/07 – IR – Praluent
2015/07 – IR – Praluent2015/07 – IR – Praluent
2015/07 – IR – PraluentSanofi
 
Mindset Investor Presentation
Mindset Investor PresentationMindset Investor Presentation
Mindset Investor PresentationRedCloud4
 
Johnson & Johnson Pharmaceutical Business Review
Johnson & Johnson Pharmaceutical Business ReviewJohnson & Johnson Pharmaceutical Business Review
Johnson & Johnson Pharmaceutical Business ReviewDeepa K
 
Jp morgan 34th annual healthcare conference
Jp morgan 34th annual healthcare conferenceJp morgan 34th annual healthcare conference
Jp morgan 34th annual healthcare conferenceimpax-labs
 
First quarter 2023 results
First quarter 2023 resultsFirst quarter 2023 results
First quarter 2023 resultsSanofi
 
Impax Fourth Quarter 2016 Earnings Call Presentation
Impax Fourth Quarter 2016 Earnings Call PresentationImpax Fourth Quarter 2016 Earnings Call Presentation
Impax Fourth Quarter 2016 Earnings Call Presentationimpax-labs
 
Experiences from an IPO at AIM, Juho Jalkanen
Experiences from an IPO at AIM, Juho Jalkanen Experiences from an IPO at AIM, Juho Jalkanen
Experiences from an IPO at AIM, Juho Jalkanen Business Turku
 
Virios Therapeutics Presentation Q3 2021
Virios Therapeutics Presentation Q3 2021Virios Therapeutics Presentation Q3 2021
Virios Therapeutics Presentation Q3 2021RedChip Companies, Inc.
 
Sustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentationSustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentationSanofi
 
2019/12 – IR – Capital Markets Day
2019/12 – IR – Capital Markets Day2019/12 – IR – Capital Markets Day
2019/12 – IR – Capital Markets DaySanofi
 
Impax laboratories credit suisse conference nov 11 2014
Impax laboratories credit suisse conference nov 11 2014Impax laboratories credit suisse conference nov 11 2014
Impax laboratories credit suisse conference nov 11 2014impax-labs
 
Second quarter 2022 results
Second quarter 2022 results Second quarter 2022 results
Second quarter 2022 results Sanofi
 
2016-Results-Presentation-2016.11.28
2016-Results-Presentation-2016.11.282016-Results-Presentation-2016.11.28
2016-Results-Presentation-2016.11.28Jaime Peña
 

Similaire à 2017/03 – IR call - Dupixent® (20)

2015/11 - IR - Sarilumab
2015/11 - IR - Sarilumab2015/11 - IR - Sarilumab
2015/11 - IR - Sarilumab
 
2018/03 – IR Call – Odyssey Outcomes
2018/03 – IR Call – Odyssey Outcomes2018/03 – IR Call – Odyssey Outcomes
2018/03 – IR Call – Odyssey Outcomes
 
2015/07 – IR – Praluent
2015/07 – IR – Praluent2015/07 – IR – Praluent
2015/07 – IR – Praluent
 
10 rtgn
10 rtgn10 rtgn
10 rtgn
 
LTRN Investor Presentation
LTRN Investor PresentationLTRN Investor Presentation
LTRN Investor Presentation
 
Mindset Investor Presentation
Mindset Investor PresentationMindset Investor Presentation
Mindset Investor Presentation
 
Johnson & Johnson Pharmaceutical Business Review
Johnson & Johnson Pharmaceutical Business ReviewJohnson & Johnson Pharmaceutical Business Review
Johnson & Johnson Pharmaceutical Business Review
 
SXTP Presentation
SXTP PresentationSXTP Presentation
SXTP Presentation
 
Jp morgan 34th annual healthcare conference
Jp morgan 34th annual healthcare conferenceJp morgan 34th annual healthcare conference
Jp morgan 34th annual healthcare conference
 
Virios Therapeutics Presentation
Virios Therapeutics PresentationVirios Therapeutics Presentation
Virios Therapeutics Presentation
 
First quarter 2023 results
First quarter 2023 resultsFirst quarter 2023 results
First quarter 2023 results
 
Impax Fourth Quarter 2016 Earnings Call Presentation
Impax Fourth Quarter 2016 Earnings Call PresentationImpax Fourth Quarter 2016 Earnings Call Presentation
Impax Fourth Quarter 2016 Earnings Call Presentation
 
Experiences from an IPO at AIM, Juho Jalkanen
Experiences from an IPO at AIM, Juho Jalkanen Experiences from an IPO at AIM, Juho Jalkanen
Experiences from an IPO at AIM, Juho Jalkanen
 
Virios Therapeutics Presentation Q3 2021
Virios Therapeutics Presentation Q3 2021Virios Therapeutics Presentation Q3 2021
Virios Therapeutics Presentation Q3 2021
 
Sustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentationSustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentation
 
2019/12 – IR – Capital Markets Day
2019/12 – IR – Capital Markets Day2019/12 – IR – Capital Markets Day
2019/12 – IR – Capital Markets Day
 
AMGEN ACC 2017
AMGEN ACC 2017  AMGEN ACC 2017
AMGEN ACC 2017
 
Impax laboratories credit suisse conference nov 11 2014
Impax laboratories credit suisse conference nov 11 2014Impax laboratories credit suisse conference nov 11 2014
Impax laboratories credit suisse conference nov 11 2014
 
Second quarter 2022 results
Second quarter 2022 results Second quarter 2022 results
Second quarter 2022 results
 
2016-Results-Presentation-2016.11.28
2016-Results-Presentation-2016.11.282016-Results-Presentation-2016.11.28
2016-Results-Presentation-2016.11.28
 

Plus de Sanofi

Fourth quarter and full year 2023 results
Fourth quarter and full year 2023 resultsFourth quarter and full year 2023 results
Fourth quarter and full year 2023 resultsSanofi
 
Third quarter 2023 Results
Third quarter 2023 ResultsThird quarter 2023 Results
Third quarter 2023 ResultsSanofi
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlightsSanofi
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlightsSanofi
 
L’essentiel des résultats du T2 2023
L’essentiel des résultats du T2 2023L’essentiel des résultats du T2 2023
L’essentiel des résultats du T2 2023Sanofi
 
Q1 2023 results highlights
Q1 2023 results highlightsQ1 2023 results highlights
Q1 2023 results highlightsSanofi
 
Sanofi Q4 and full year 2022 results
Sanofi Q4 and full year 2022 resultsSanofi Q4 and full year 2022 results
Sanofi Q4 and full year 2022 resultsSanofi
 
2022 full-year results highlights
2022 full-year results highlights2022 full-year results highlights
2022 full-year results highlightsSanofi
 
L’essentiel des résultats annuels 2022
L’essentiel des résultats annuels 2022 L’essentiel des résultats annuels 2022
L’essentiel des résultats annuels 2022 Sanofi
 
Presentation of the Q3 2022 Results
Presentation of the Q3 2022 ResultsPresentation of the Q3 2022 Results
Presentation of the Q3 2022 ResultsSanofi
 
Q3 2022 Results
Q3 2022 ResultsQ3 2022 Results
Q3 2022 ResultsSanofi
 
Résultats financiers du 3e trimestre 2022
Résultats financiers du 3e trimestre 2022Résultats financiers du 3e trimestre 2022
Résultats financiers du 3e trimestre 2022Sanofi
 
Q1 First quarter results
Q1 First quarter resultsQ1 First quarter results
Q1 First quarter resultsSanofi
 
Résultats du premier trimestre 2022
Résultats du premier trimestre 2022Résultats du premier trimestre 2022
Résultats du premier trimestre 2022Sanofi
 
First quarter 2022 results
First quarter 2022 resultsFirst quarter 2022 results
First quarter 2022 resultsSanofi
 
Q4 and Full Year Results 2021
Q4 and Full Year Results 2021Q4 and Full Year Results 2021
Q4 and Full Year Results 2021Sanofi
 
Sanofi Q4 2021 Final Financial Results
Sanofi Q4 2021 Final Financial ResultsSanofi Q4 2021 Final Financial Results
Sanofi Q4 2021 Final Financial ResultsSanofi
 
Presentation Part 2 – Leading with innovation
Presentation Part 2 – Leading with innovationPresentation Part 2 – Leading with innovation
Presentation Part 2 – Leading with innovationSanofi
 
Presentation Part 1 – Growing current business
Presentation Part 1 – Growing current business Presentation Part 1 – Growing current business
Presentation Part 1 – Growing current business Sanofi
 
Q3 2021 Financial Results
Q3 2021 Financial ResultsQ3 2021 Financial Results
Q3 2021 Financial ResultsSanofi
 

Plus de Sanofi (20)

Fourth quarter and full year 2023 results
Fourth quarter and full year 2023 resultsFourth quarter and full year 2023 results
Fourth quarter and full year 2023 results
 
Third quarter 2023 Results
Third quarter 2023 ResultsThird quarter 2023 Results
Third quarter 2023 Results
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlights
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlights
 
L’essentiel des résultats du T2 2023
L’essentiel des résultats du T2 2023L’essentiel des résultats du T2 2023
L’essentiel des résultats du T2 2023
 
Q1 2023 results highlights
Q1 2023 results highlightsQ1 2023 results highlights
Q1 2023 results highlights
 
Sanofi Q4 and full year 2022 results
Sanofi Q4 and full year 2022 resultsSanofi Q4 and full year 2022 results
Sanofi Q4 and full year 2022 results
 
2022 full-year results highlights
2022 full-year results highlights2022 full-year results highlights
2022 full-year results highlights
 
L’essentiel des résultats annuels 2022
L’essentiel des résultats annuels 2022 L’essentiel des résultats annuels 2022
L’essentiel des résultats annuels 2022
 
Presentation of the Q3 2022 Results
Presentation of the Q3 2022 ResultsPresentation of the Q3 2022 Results
Presentation of the Q3 2022 Results
 
Q3 2022 Results
Q3 2022 ResultsQ3 2022 Results
Q3 2022 Results
 
Résultats financiers du 3e trimestre 2022
Résultats financiers du 3e trimestre 2022Résultats financiers du 3e trimestre 2022
Résultats financiers du 3e trimestre 2022
 
Q1 First quarter results
Q1 First quarter resultsQ1 First quarter results
Q1 First quarter results
 
Résultats du premier trimestre 2022
Résultats du premier trimestre 2022Résultats du premier trimestre 2022
Résultats du premier trimestre 2022
 
First quarter 2022 results
First quarter 2022 resultsFirst quarter 2022 results
First quarter 2022 results
 
Q4 and Full Year Results 2021
Q4 and Full Year Results 2021Q4 and Full Year Results 2021
Q4 and Full Year Results 2021
 
Sanofi Q4 2021 Final Financial Results
Sanofi Q4 2021 Final Financial ResultsSanofi Q4 2021 Final Financial Results
Sanofi Q4 2021 Final Financial Results
 
Presentation Part 2 – Leading with innovation
Presentation Part 2 – Leading with innovationPresentation Part 2 – Leading with innovation
Presentation Part 2 – Leading with innovation
 
Presentation Part 1 – Growing current business
Presentation Part 1 – Growing current business Presentation Part 1 – Growing current business
Presentation Part 1 – Growing current business
 
Q3 2021 Financial Results
Q3 2021 Financial ResultsQ3 2021 Financial Results
Q3 2021 Financial Results
 

Dernier

AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsMedicoseAcademics
 
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfHongBiThi1
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptxWINCY THIRUMURUGAN
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024EwoutSteyerberg1
 
ayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologypptayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologypptPradnya Wadekar
 
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.pptRamDBawankar1
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE Mamatha Lakka
 
Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Peter Embi
 
AORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectionAORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectiondrhanifmohdali
 
Mental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil ThirusanguMental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil Thirusangu Medical University
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondSujoy Dasgupta
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptPradnya Wadekar
 
Neurological history taking (2024) .
Neurological  history  taking  (2024)  .Neurological  history  taking  (2024)  .
Neurological history taking (2024) .Mohamed Rizk Khodair
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyMedicoseAcademics
 
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdfSGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdfHongBiThi1
 
pA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologypA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologyDeepakDaniel9
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionkrishnareddy157915
 
Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Vaikunthan Rajaratnam
 

Dernier (20)

AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functions
 
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024
 
ayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologypptayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologyppt
 
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
 
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE
 
Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024
 
AORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectionAORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissection
 
Mental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil ThirusanguMental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil Thirusangu
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and Beyond
 
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.ppt
 
Neurological history taking (2024) .
Neurological  history  taking  (2024)  .Neurological  history  taking  (2024)  .
Neurological history taking (2024) .
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before Pregnancy
 
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdfSGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
 
pA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologypA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacology
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung function
 
Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.
 

2017/03 – IR call - Dupixent®

  • 1. 1 DUPIXENT® FDA Approval Call March 28, 2017
  • 2. 2 Sanofi 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, Sanofi’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, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  • 3. 3 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 Dupixent® (dupilumab) Injection; 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 Dupixent for the treatment of uncontrolled moderate-to-severe atopic dermatitis in jurisdictions outside the United States and other potential indications; unforeseen safety issues and possible liability resulting from the administration of products and product candidates in patients, including without limitation Dupixent; serious complications or side effects in connection with the use of Regeneron's products and product candidates (such as Dupixent) 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 Dupixent; 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, Bayer, and Teva Pharmaceutical Industries Ltd. (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, including without limitation the patent litigation relating to Praluent® (alirocumab) Injection, the permanent injunction granted by the United States District Court for the District of Delaware that, if upheld on appeal, would prohibit Regeneron and Sanofi from marketing, selling, or manufacturing Praluent in the United States, the outcome of any appeals regarding such injunction, the ultimate outcome of such litigation, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. 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, 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.
  • 4. 4 Agenda Opening remarks – DUPIXENT®, a breakthrough innovation ● Olivier Brandicourt – Chief Executive Officer, Sanofi ● Leonard S. Schleifer, MD, PhD – Founder, President and Chief Executive Officer, Regeneron Q&A Session ● George D. Yancopoulos, MD, PhD – Founding Scientist, President and Chief Scientific Officer, Regeneron ● Elias Zerhouni, MD – President, Global Research & Development, Sanofi ● Bill Sibold – Global Head Multiple Sclerosis, Oncology & Immunology, Sanofi Genzyme ● Robert Terifay – Executive Vice President, Commercial, Regeneron
  • 5. 5 DUPIXENT®: A Breakthrough Treatment for Moderate-to- Severe Atopic Dermatitis (AD) ● A key new product launch for Regeneron and Sanofi ● Important addition to Sanofi Genzyme specialty care business ● Science driving innovation: First biologic therapy for AD approved in the US ● Excited to bring product rapidly to market to help address high unmet need ● Kevzara™ (sarilumab) BLA resubmitted
  • 6. 6 Il-4/IL-13 Considered Common Drivers in the Following Diseases(1) Il-4/IL-13 signaling is considered to be central to many Type-2 mediated allergic diseases IL-4/ IL-13 Atopic Dermatitis Asthma Nasal Polyps Eosinophilic Esophagitis (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
  • 7. 7 ● Moderate-to-severe form of AD can be a debilitating, life-altering condition that impacts people’s day-to-day functioning ● Characterized by intense itching and recurrent eczematous lesions ● Multifactorial etiology involving immune-mediated inflammation, skin-barrier defect, genetic factors and environmental triggers ● Although it often starts in infancy, it is also prevalent in adults AD is a Chronic, Inflammatory Skin Disease, Characterized by Intractable Pruritus
  • 8. 8 DUPIXENT®: The First FDA Approved Biologic for Adults with Uncontrolled Moderate-to-Severe AD DUPIXENT® INDICATIONS AND USAGE DUPIXENT® is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT® can be used with or without topical corticosteroids. DUPIXENT® WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions, including generalized urticaria and serum sickness or serum sickness-like reactions, were reported in subjects who received DUPIXENT®. If a systemic hypersensitivity reaction occurs, discontinue DUPIXENT® immediately and initiate appropriate therapy. Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in subjects who received DUPIXENT®. Conjunctivitis was the most frequently reported eye disorder. Patients should report new onset or worsening eye symptoms to their healthcare provider. Comorbid Asthma: Safety and efficacy of DUPIXENT® have not been established in the treatment of asthma. Advise patients with comorbid asthma not to adjust or stop their asthma treatment without consultation with their physicians. Parasitic (Helminth) Infections: Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if DUPIXENT® will influence the immune response against helminth infections
  • 9. 9 U.S. Launch Focused on Patients with the Highest Unmet Medical Need Patient Focus at Launch Moderate-to-severe AD patients intolerant to or inadequate response to an existing therapy (Topical prescription therapies and Oral/systemic steroids or Immuno-suppressants) Around 300,000 adult patients in the U.S. ● 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 Pictures from Phase 3 clinical trial provided for illustrative purposes only to show how the clinical parameters above may correlate to the clinical presentation of a patient.(1,2) (1) Images are taken from same 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%. (2) The most common side effects in clinical trials included injection site reactions, eye and eyelid inflammation, including redness, swelling and itching, and cold sores in mouth or on lips IGA: Investigator Global Assessment BSA: Body Surface Area EASI: Eczema Area and Severity Index NRS: Numerical Rating Scale IGA 4 IGA 1
  • 10. 10 Target Physicians who Treat AD Patients and Have Experience Prescribing Biologics Physician Focus at Launch Dermatologists (i.e. Psoriasis) Allergists/Immunologists Up to 7,000 doctors in the U.S.
  • 11. 11 A Commitment to Responsible Pricing: Valuing a Breakthrough Therapy for Moderate-to-Severe AD Breakthrough, First-in-Class Therapy Disease Burden/Treatment Landscape Cost-Effectiveness Analyses Physician, Patient, Payer & Other Stakeholder Feedback Ensuring Continued Investment in Biopharma Innovation RESPONSIBLE PRICING FOR DUPIXENT® Clinical & QoL Benefit QoL: Quality of Life Careful consideration of several clinical and economic value measures in pricing DUPIXENT® Qualitative measures Quantitative measures Comparable Biologic Pricing
  • 12. 12 WAC = Wholesale Acquisition Cost (1) Moderate-to-severe AD compared with moderate to severe psoriasis. As measured by the Dermatology Life Quality Index (DLQI) , a scale where a higher number means a worse impact on quality of life. DLQI data derived from 11 published clinical studies of psoriasis treatments in patients with moderate to severe psoriasis, data on file. Moderate-to-severe AD DLQI data derived from Phase 3 SOLO 1 and SOLO 2 studies clinical studies report, data on file. (2) Yearly maintenance treatment cost based on WAC prices in the U.S. (not reflective of discounts or rebates) and excludes one-time loading dose(s). (3) Annual treatment costs for Dupixent in AD compare favorably with biologic treatments for psoriasis including adalimumab, etanercept, ixekizumab, secukinumab and ustekinumab. The chart represents a comparison of list prices and is not intended to imply a comparison of safety or efficacy. DUPIXENT® WAC is Lower than Biologics Used to Treat Psoriasis(1) 0 5 10 15 20 25 30 BaselineMeanDLQIScore 11.5 - 13 Moderate-to-Severe Atopic Dermatitis 14.5 - 16 Moderate-to-Severe Psoriasis Humira Enbrel Stelara Dupixent Psoriasis Biologic Treatments AD is at Least as Burdensome a Disease as Psoriasis(1) Yet DUPIXENT® WAC is Lower than Psoriasis Biologics(2,3) (in USD) $30,000 $80,000 $70,000 $50,000 $10,000 $60,000 $40,000 $90,000 $20,000 $0 ~$41,000 ~$83,000 $37,000
  • 13. 13 Working Alongside Payers to Provide Appropriate Access For Patients Provide Patient Access ● Consultation with PBMs Aligned view on the burden of disease, the unmet need that exists and the right patient for treatment ● Early Formulary Coverage Expected(1) for a large population of patients within days ● Appropriate Utilization Management Criteria Expect physician attestation, specialist-only prescription, and no step-edits through systemic immunosuppressant therapies Payer Discussions (1) Individual plans may vary
  • 14. 14 Comprehensive Support to Optimize Patient Access and Minimize Barriers to Treatment Patient Support & Coverage Patient Access ● $0 Copay Program for eligible patients ● Patient Assistance Program ● Education and personalized nurse support ● Benefits Investigation ● Prior Authorization Assistance ● Appeals Support DUPIXENT® expected to be commercially available in the U.S. later this week