credit suisse healthcare conference...2017/11/07 · 9m 2015 9m 2016 9m 2017 €1,540m €362m...
TRANSCRIPT
Credit Suisse Healthcare Conference Bill Sibold – Executive Vice President, Sanofi Genzyme
Scottsdale, Arizona - November 8, 2017
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, 2016. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Forward Looking Statements
2
3
Agenda
Sanofi Q3 and YTD 2017 Performance
New Sanofi Genzyme Immunology Franchise
Re-Building a Competitive Position in Oncology
Specialty Care Continues to Drive Growth for Sanofi
4
Company Sales and Business EPS Grew at CER in Q3
Business EPS
Q3 2017
€1.71
Q3 2016
€1.79
+1.1% at CER
Company Sales
Q3 2017
€9,053m
Q3 2016
€9,028m
+4.7% at CER
CER: Constant Exchange Rates
9M 2017 Company Sales
5
YTD Sales Slightly Higher Despite Significant LoEs
LoEs: Losses of Exclusivity
(1) Primarily includes SPMSD (€161m) and BI CHC (€1,131m on a Full Sales recognition
basis; €1,073m when adjusting for progressive sales recognition) in 9M 2016. Minor
disposal of CHC activities in China is also included.
(2) 9M 2016 Sales at Constant Structure
(3) Change in sales at CER
(4) Growth at Constant Exchange Rates (CER) and Constant Structure (CS)
Fx 9M 2017
€26,364m -€133m
Sales
€315m
9M 2016
CS
€26,182m
BI CHC /
SPMSD
€1,228m
9M 2016
€24,954m +1.2%
at CER/CS(4)
(1) (2)
(3)
Q3 2017 Sales by Global Business Unit
6
Specialty Care and Vaccines Delivered Strong Growth
while Diabetes Declined in-Line with Expectations
Growth
at CER/CS(1)
(1) Growth at CER and Constant Structure on the basis of Q3 2016 sales including CHC
sales from Boehringer Ingelheim, SPMSD sales and others
(2) Does not include Emerging Markets sales
(3) On a CER basis, growth was +11.0%
(4) Consumer Healthcare includes sales in Emerging Markets
(5) On a CER basis, growth was +48.5%
(6) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care
(7) Emerging Markets: World excluding U.S., Canada, Western & Eastern Europe
(except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico
(8) Excluding global Consumer Healthcare sales and Vaccines Pictures by Freepik
Company Sales €9,053m
-0.2%
€1,298m
Diabetes & Cardiovascular -14.8%
€1,390m
Sanofi Genzyme (Specialty Care) +13.9%
€1,916m
Sanofi Pasteur (Vaccines) +7.2%
€3,317m
General Medicines & Emerging Markets -3.1% (6,7,8)
(2)
(2)
(4) €1,132m
Consumer Healthcare +1.0% (5)
(3)
7
Agenda
Sanofi Q3 and YTD 2017 Performance
New Sanofi Genzyme Immunology Franchise
Re-Building a Competitive Position in Oncology
Specialty Care Continues to Drive Growth for Sanofi
● Specialty Care franchise up +13%
(+14% first nine months 2017)
● Dupixent sales reached €75m in the U.S.
● Kevzara captured 15% NBRx market share of
subcutaneously administered IL-6 in month 4 post
launch in the U.S.(1)
● Rare Disease franchise up +2.7% due to phasing
in EM and erosion of minor brands
● Multiple Sclerosis franchise sustained double-digit
growth in a competitive market
Global Specialty Care
Franchise Sales
8
Specialty Care Delivers Another Quarter of
Double-Digit Growth in Q3
Q3 2016 Q3 2017
Immunology
Rare Diseases
Multiple Sclerosis
Oncology
€708m
€1,633m
€698m +2.7%
€495m +15.7%
€446m
€363m €363m
+5.0%
€1,517m
+12.5% at CER
All growth at CER unless otherwise stated
(1) Source: IMS NPA MD September 2017
9M 2015 9M 2016 9M 2017
Rare Diseases Franchise Sales Increased 5.3% YTD
Rare Diseases Sales
€2,162m
€2,061m
€1,890m
● Fabry franchise grew +10% to €542m
● Focus primarily on nephrologists and
family tree mapping to drive patient
identification
● Pompe franchise grew +10% to €584m
● Educate on the importance of testing
of high risk patients in neurology and
neuromuscular specialty areas
&
9
+5.3% at CER
Other
10
9M 2015 9M 2016 9M 2017
€1,540m
€362m +18.5%
at CER
€761m
● Fastest growing oral RMS product
with sales up +27% 9M 2017(1)
● Increasing breadth and depth of prescribing
with sales up +19% 9M 2017
● Momentum continues, YTD 62% patient
growth
10
Multiple Sclerosis Sales
€1,178m +26.9%
at CER
Multiple Sclerosis Franchise Continued to Deliver
Strong Growth First 9 Months 2017
€1,236m
DMT: Disease Modifying Therapy
(1) IMS NPA Market Dynamics
+24.8% at CER
11
Attractive Efficacy, Safety, Tolerability and
Once-Daily Oral Dosing Profile(1)
● Approved in 80 countries with >80,000 patients
currently treated worldwide
● Growing and positive experience among patients
and neurologists(2)
● Established safety and tolerability with
over 10 years of clinical trial data(3)
● Only oral RMS treatment to:
● Significantly reduce the risk of disability progression
in two Phase III studies(4)
● Studied in newly diagnosed RMS patients, 72% of
whom remained relapse free(5)
RMS: relapsing multiple sclerosis
(1) Aubagio® (teriflunomide) is effective across key measures of disease activity: sustained
disability progression (14 mg only), annualized relapse rate, and MRI activity.
Common side effects with Aubagio® led to treatment discontinuation rates ≤3.3% in
clinical trials.
(2) Sanofi Genzyme market research
(3) The TEMSO Extension Study: Kappos L et al. ECTRIMS 2015. P1099, O’Connor
P et al. ECTRIMS 2015. P555.
(4) TEMSO study: O’Connor P et al. N Engl J Med. 2011;365:1293-1303; TOWER
study: Confavreux C et al. Lancet Neurol. 2014;13:247-256.
(5) TOPIC study: Miller AE, et al. Lancet Neurol. 2014;13:977-986.
(1) IMS NPA/NSP, September 2017
(2) Oral category includes Aubagio®, Gilenya®, Tecfidera® ; Intravenous category includes Tysabri®, LEMTRADA®, Ocrevus™ ;
Injectable category includes Avonex®, Betaseron/Betaferon®, Copaxone®, Glatopa®, Rebif®, Extavia®, Plegridy™, Zinbryta™
(3) IMS NPA, week ending October 20th, 2017
Making Steady TRx Share Gains in Highly
Competitive Market
Aubagio® is the Fastest Growing
Oral Relapsing MS Product(2)
U.S. TRx Share(3)
Oral Therapies Have Gained
Significant Market Share(1)
U.S. TRx Share(3)
17% 29% 34% 37% 38%
74% 61% 55% 52% 50%
9% 10% 10% 11% 12%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2013 2014 2015 2016 9M 2017
Injectables Intravenous Orals
Tecfidera®
22.0%
0%
5%
10%
15%
20%
25%
Oct-15 Apr-16 Oct-16 Apr-17 Oct-17
Gilenya®
12.1%
9.6%
12
13
Physician Experience and Real World Patient
Results Expected to Drive Continued Growth
● Approved in more than 65 countries with over 16,000 patients
treated commercially worldwide
● Over 15 years clinical trial data
● Over 10,000 patient-years of follow up
● Only relapsing MS therapy in the U.S. which offers efficacy in the
absence of continuous treatment(1)
● No retreatment with Lemtrada® after the initial 2 courses in the core
studies for a majority of patients through Year 7(2)
● ICER report finds Lemtrada® “provided the highest number of
QALYs gained while costing less than all other treatments except
supportive care”(3)
DMTs: Disease-Modifying Therapies
(1) Sustained improvements in relapse, disability, and MRI over 5 years in active RRMS in the absence of continuous dosing demonstrated in CARE-MS I and II extension studies
(2) The percentages of those not receiving retreatment with Lemtrada were: 61% from CARE-MS I and 52% from CARE-MS II
(3) Institute for Clinical and Economic Review (ICER) Final Evidence Report on Disease-Modifying Therapies for Multiple Sclerosis, including daclizumab and ocrelizumab (March 2017
14
Agenda
Sanofi Q3 and YTD 2017 Performance
New Sanofi Genzyme Immunology Franchise
Re-Building a Competitive Position in Oncology
Specialty Care Continues to Drive Growth for Sanofi
Positioned to Grow IL-6 Class and Benefit
from Evolving RA(1) Treatment Paradigm
15
● Launch underway in the U.S. and EU
● U.S. product label includes:
● Consistent efficacy in both MTX-IR(2) and
TNF-IR(3) patients
● Radiographic data supportive of clinical
profile on joint erosion and space narrowing
● Bi-weekly administration for both 200mg and
150mg doses
● Improved market access for 2018
● Captured 15% NBRx share in new
subcutaneous RA IL-6 category in September
(1) Rheumatoid arthritis
(2) MTX-IR: Methotrexate inadequate response
(3) TNF-IR: Anti-TNFa inadequate response
Consistent Efficacy Data
in MTX-IR and TNF-IR patients % of patients achieving ACR20/50/70 at week 24
19.8% 24.8%
37.0% 45.6%
58.0% 66.4%
33.4%
16.6% 7.3%
Kevzara 150mg Kevzara 200mg Placebo
18.2%
ACR70
19.9% 16.3%
ACR50
37.0% 40.8%
ACR20
55.8% 60.9%
33.7%
7.2%
MO
BIL
ITY
MT
X-I
R(3
)
TA
RG
ET
TN
F-I
R(4
)
16
Kevzara - Global Launches of IL-6 mAb in RA Ongoing
(1) Rheumatoid Arthritis
(2) Mechanism of Action
(3) MTX-IR: methotrexate Inadequate Responder; TNF-IR: TNF Inadequate Responder
(4) Based on one head to head superiority study comparing sarilumab and Humira in improving signs and symptoms of RA in adults (MONARCH).
A second confirmatory study has not been conducted. Neutropenia, which was not associated with infections, was more common with sarilumab than Humira.
Not included in the initial BLA filed with FDA; Humira (adalimumab) is an AbbVie brand
(5) Every 2 weeks
Trends in RA(1)…
● Use of non-TNFα MOA(2) products is increasing
● Anti-TNFα cycling declining
● Increasing number of patients on
monotherapy
● Patient preference for
sub-cutaneous administration
● IL-6 plays a key role in the
pathophysiology of RA
● Positive Phase 3 results
in MTX-IR and TNF-IR patients(3)
● Positive monotherapy data
versus Humira monotherapy(4)
● Sub-cutaneous administration with
less frequent Q2W(5) dosing
… potentially addressed by Kevzara®
Dupilumab: A Pipeline in a Product – First Approval in
Adults with Moderate-to-Severe Atopic Dermatitis (AD)
Il-4/IL-13 signaling is
considered to be central
to many Type-2 mediated
diseases
IL-4/ IL-13
Atopic Dermatitis
Asthma
Nasal Polyps
Eosinophilic Esophagitis
Food Allergy
(1) Dupilumab is under clinical development in asthma, nasal polyps and eosinophilic esophagitis and its safety and efficacy in these indications have not been
fully evaluated by any Regulatory Authority 17
18
Global Rollout Underway
● Dupixent U.S. launch trend ahead of other
recently launched biologics in dermatology
● Cumulatively over 23,000 patients prescribed
since launch
● Over 7,100 HCPs have prescribed
● ~70% of target physicians are repeat prescribers
● Continued progress with U.S. market access
● 79% of commercial lives covered(1)
● Prior Authorization approval rate >80%
● European approval received in September and
launch in Germany planned by end 2017
0
500
1,000
1,500
2,000
2,500
3,000
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29
DupixentÒ CosentyxÒ TaltzÒCosentyx Taltz
Weekly TRx since launch
Source: IMS NPA in the U.S. Last week included is October 13th 2017.
(1) Coverage by health plans that currently have a published Dupixent policy but may not have a contract in place
weeks
19
Positive Phase 3 QUEST Study for Dupilumab
in Asthma(1,2)
EoS: Blood eosinophils levels at baseline
FEV1 : Forced Expiratory Volume
Results for the 200mg and 300mg dose groups were generally comparable on
both exacerbations and FEV1
(1) Dupilumab is under investigation in Asthma and the safety and efficacy have
not been evaluated by any regulatory authorities
(2) In adults and adolescents
(3) Adverse Events
(4) Injection Site Reactions
(5) At 300mg every 2 weeks. p<0.001 for all groups
(6) Primary Endpoint
● Dupilumab Phase 3 QUEST study confirms
safety and efficacy profile in uncontrolled
persistent asthma(1)
● First biologic to demonstrate both reduction in
exacerbations and FEV1 improvement in overall
population in Phase 3
● Overall rate of AEs(3) similar to placebo; ISR(4)
more common with dupilumab (17%) than
placebo (8%)
● On track for sBLA submission in Q4 2017
LIBERTY ASTHMA QUEST Primary endpoints
p<0.001
p<0.001 p<0.001
Reduction in s
evere
asth
ma a
ttacks
at 52 w
eeks
(5)
300 EoS/L 150 EoS/L Overall population(6)
Mean F
EV
1
impro
vem
ent at
12 w
eeks
(5)
-46% -60% -67%
+130mL / +9% +150mL / +11%
+240mL / +18%
Placebo dupilumab
20
● Dupilumab significantly reduced maintenance
OCS use in severe asthma patients
● 80% of dupilumab patients reduced OCS use by at
least half compared to 50% for placebo in the overall
population
● 59% reduction in asthma attacks in overall
population despite reduced OCS use
● Dupilumab significantly increased FEV1
(+220mL /15%) compared to placebo
● Safety profile consistent with previous Phase 3
studies
Positive Phase 3 VENTURE Study Further Strengthens
Dupilumab’s Clinical Profile in Asthma(1,2)
LIBERTY ASTHMA VENTURE Primary endpoint and FEV1 improvement
p<0.001
p<0.001
Reduction in
main
tenance
cort
icoste
roid
s
use
Overall population(3) 300 EoS/L
-70%
Placebo dupilumab
All data at week 24
EoS: Blood eosinophils levels at baseline OCS: Oral corticosteroids
FEV1 : Forced Expiratory Volume
The overall rates of adverse events, including infections, conjunctivitis (2 events
dupilumab, 3 events placebo), and herpes were comparable between the dupilumab
and placebo groups. Injection site reactions were more common with dupilumab (9% of
patients) than placebo (4% of patients).
(1) Dupilumab is under investigation in Asthma and the safety and efficacy have not
been evaluated by any regulatory authorities
(2) In adults and adolescents
(3) Primary endpoint
-42% -80%
-43%
p<0.0001
Overall population(3) 300 EoS/L
Mean F
EV
1
impro
vem
ent +220mL / +15%
+320mL / +25%
21
Agenda
Sanofi Q3 and YTD 2017 Performance
Specialty Care Continues to Drive Growth for Sanofi
New Sanofi Genzyme Immunology Franchise
Re-Building a Competitive Position in Oncology
22
Re-Building a Competitive Position in Oncology
MoA: Mechanism of Action
(1) HDeckert, et al. Clin Cancer Res 2014;20:4574–83.
(2) For the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC
Isatuximab
(anti-CD38)
● Pivotal Phase 2/3 study in cutaneous squamous cell carcinoma ongoing
● FDA breakthrough designation received in CSCC(2)
● Several other indications with other targets/modalities being considered
Cemiplimab
(PD-1)
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 Q4 2016
● Potential indications beyond multiple myeloma being explored
SAR439684 (PD-1 inhibitor): Registrational Phase 2
Underway Supported by Positive Early Results in CSCC
23
● PD-1 (SAR439684) positive Phase 1 study
results in advanced CSCC(1)
● 46.2% ORR(2) and 69.2% DCR(3)
● Generally well tolerated(4)
● Anticipated FDA submission in mCSCC
in Q1 2018 based on current Phase 2
● Additional studies initiated:
● 1st line NSCLC(5): Phase 3 started
● Advanced BCC(6): Phase 2 started
● Recurrent or Metastatic, Platinum-refractory
Cervical Cancer: Phase 3 started
In collaboration with Regeneron
SAR439684 is an investigational agent under clinical
development and its safety and efficacy has not been fully
evaluated by any Regulatory Authority; also known as
REGN2810
(1) Cutaneous Squamous Cell Carcinoma
(2) Overall Response Rate
(3) Disease Control Rate
(4) The most common treatment-related adverse event of
any grade was fatigue (23.1%). All grade 3 or higher
adverse events occurred once and included arthralgia
(3.8%), maculopapular rash (3.8%), asthenia (3.8%),
aspartate aminotransferase (AST) elevation (3.8%)
and alanine aminotransferase (ALT) elevation (3.8%).
(5) Non-Small Cell Lung Cancer
(6) Basal Cell Carcinoma
(7) Data presented at ASCO 2017
months
PD-1 ORR in Phase 1 CSCC(7)
Percent change in target lesions from baseline
mCSCC locally advanced
(100%)
(80%)
(60%)
(40%)
(20%)
0%
20%
40%
0 2 4 6 8 10 12
24
Conclusion
Specialty Care Continues to Drive Growth for Sanofi 1
Re-Building a Competitive Position in Oncology 5
U.S. Dupixent® Launch Performing Ahead of Expectations 4
Core Rare Disease Brands Remain Strong 2
Multiple Sclerosis Franchise Continues to Deliver Strong Growth 3
25
Invitation to Sanofi’s “Sustaining Innovation” Events
December 13, 2017
Paris - France
December 15, 2017
Boston - U.S.
(1) A live webcast will be available on www.sanofi.com
Analyst meeting(1) to discuss
Sanofi’s R&D strategy and
development pipeline
Lunch meeting with Management
Registration
8:00am
Day ends at
2:30pm
Series of
Q&A sessions
Lunch meeting with Management
Registration
8:00am
Day ends at
2:30pm
Please
register by
December 1, 2017