Paris, April 26,
2019
Sanofi delivers
strong Q1 2019 business EPS growth of 9.4% at CER
|
Q1 2019 |
Change |
Change
at CER |
IFRS net sales
reported |
€8,391m |
+6.2% |
+4.2% |
IFRS net income
reported |
€1,137m |
+11.9% |
- |
IFRS EPS
reported |
€0.91 |
+12.3% |
- |
Business net
income(1) |
€1,765m |
+10.5% |
+9.0% |
Business
EPS(1) |
€1.42 |
+10.9% |
+9.4% |
First-quarter sales(2)
growth driven by Specialty Care, Vaccines and strong contribution
from Emerging Markets
-
Net sales were €8,391 million, an increase of
6.2% on a reported basis, 4.2%(2) at CER and
3.8% at CER/CS(3).
-
Sanofi Genzyme GBU sales were up 30.8% (16.0% at
CER/CS(3)), driven by
Dupixent® and
consolidation of Bioverativ.
-
Vaccines sales up 20.1%, reflecting the recovery
and growth of Pentaxim® in China and
Menactra® strength in
Emerging Markets.
-
CHC sales up 0.6%, as Emerging Markets growth
more than offset lower sales in mature markets and non-core
divestments.
-
Primary care GBU sales were down 17.0% (-11.8%
at CER/CS) impacted by lower diabetes sales and divestiture of EU
generics.
-
Emerging Markets sales(4) grew
strongly (up 13.6%) across all regions, primarily driven by
China.
Q1 2019 business EPS(1) growth
reflected sales performance, favorable product mix and cost
discipline
-
Q1 2019 business net income increased 10.5% to
€1,765 million and 9.0% at CER.
-
Business EPS(1) in the
first quarter was up 9.4% at CER to €1.42.
-
IFRS EPS was €0.91 (up 12.3%).
Full-year 2019 business EPS(1)
guidance confirmed
Key regulatory milestones achieved in R&D
-
Dupixent® approved in
the U.S. for atopic dermatitis in adolescent patients.
-
FDA granted Priority Review in the U.S. for
Dupixent® in adults
with chronic rhinosinusitis with nasal polyps.
-
CHMP recommended approval of Dupixent®
in EU for severe asthma in adults and adolescents.
-
Praluent® label
extension approved by EMA to include reduction of the risk of
cardiovascular events in eligible patients.
-
Libtayo® approved in
Canada for cutaneous squamous cell carcinoma.
-
CHMP recommended approval in EU and U.S. FDA
issued a CRL(6).regarding
ZynquistaTM for type 1
diabetic adult patients.
|
Sanofi Chief Executive Officer, Olivier Brandicourt,
commented:
"I am pleased with the strong start in 2019 as we
sustained our new growth phase and delivered business EPS growth of
9.4%. We executed on key launches in Specialty Care led by the
impressive uptake of Dupixent® in atopic
dermatitis and asthma and also delivered strong growth in Vaccines.
At the same time, our new GBU structure enabled us to optimize our
growth opportunity in China & Emerging Markets and to adapt to
the pressures in Primary Care. Based on our performance in the
first quarter, we remain confident in the growth outlook for our
business over the rest of the year despite challenging industry
dynamics." |
(1) In order to
facilitate an understanding of operational performance, Sanofi
comments on the business net income statement. Business net income
is a non-GAAP financial measure (see Appendix 8 for definitions).
The consolidated income statement for Q1 2019 is provided in
Appendix 3 and a reconciliation of reported IFRS net income to
business net income is set forth in Appendix 4; (2) Changes in net
sales are expressed at constant exchange rates (CER) unless
otherwise indicated (see Appendix 8); (3) Constant Structure:
Adjusted for Bioverativ acquisition and divestment of European
Generics business; (4) See definition page 8; (5) 2018 business EPS
was €5.47; (6) Complete Response Letter.
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2019
first-quarter Sanofi sales
Unless otherwise indicated, all percentage changes in sales
in this press release are stated at CER(7). |
In the first quarter of 2019,
Company sales were €8,391 million, up 6.2% on a reported basis.
Exchange rate movements had a positive effect of 2.0 percentage
points mainly driven by the U.S. dollar which largely offset the
negative impact from the Argentine Peso, Turkish Lira, Brazilian
Real and Russian Ruble. At CER, Company sales increased 4.2%.
Global Business
Units
The table below presents sales by
Global Business Unit (GBU). Please note that Emerging Markets sales
for Specialty Care and Primary Care are included in the China &
Emerging Markets GBU.
Net Sales by GBU
(€ million) |
Q1 2019 |
Change
at CER |
Sanofi Genzyme
(Specialty Care)(a) |
|
2,019 |
|
+30.8%(c) |
Primary
Care(a) |
|
2,285 |
|
-17.0%(d) |
China & Emerging
Markets(b) |
|
1,958 |
|
+10.3% |
Total
Pharmaceuticals |
|
6,262 |
|
+3.1% |
Consumer Healthcare (CHC) |
|
1,256 |
|
+0.6% |
Sanofi Pasteur (Vaccines) |
|
873 |
|
+20.1% |
Total net sales |
|
8,391 |
|
+4.2%(e) |
(a) Does not include China &
Emerging Markets sales - see definition page 8; (b) Includes
Emerging Markets sales for Primary Care and Specialty Care;
(c)+16.0% at CS; (d)-11.8% at CS; (e)+3.8% at CS.
Global
Franchises
The table below presents
first-quarter 2019 sales by global franchise, including Emerging
Markets sales, to facilitate comparisons. Appendix 1 provides a
reconciliation of sales by GBU and franchise.
Net sales by Franchise
(€ million) |
Q1 2019 |
Change
at CER |
Developed
Markets |
Change
at CER |
Emerging
Markets |
Change
at CER |
Specialty Care franchises |
2,327 |
+31.2%(1) |
2,019 |
+30.8% |
308 |
+33.6% |
Rare Disease |
766 |
+10.1% |
613 |
+3.9% |
153 |
+37.2% |
Multiple
Sclerosis |
529 |
+5.9% |
507 |
+4.6% |
22 |
+41.2% |
Oncology |
399 |
+7.8% |
273 |
+2.4% |
126 |
+21.2% |
Immunology |
359 |
+186.3% |
356 |
+183.8% |
3 |
- |
Rare Blood
Disorder |
274 |
+296.9%(2) |
270 |
+290.6% |
4 |
- |
Primary Care franchises |
3,935 |
-8.3%(3) |
2,285 |
-17.0%(4) |
1,650 |
+6.6% |
Established Rx
Products(5) |
2,506 |
-9.3%(6) |
1,307 |
-18.8%(7) |
1,199 |
+3.5% |
Diabetes |
1,294 |
-6.9% |
849 |
-15.9% |
445 |
+15.3% |
Cardiovascular |
135 |
-0.8% |
129 |
-2.4% |
6 |
+50.0% |
Consumer Healthcare |
1,256 |
+0.6% |
833 |
-3.0% |
423 |
+8.1% |
Vaccines |
873 |
+20.1% |
524 |
+5.7% |
349 |
+48.3% |
Total net sales |
8,391 |
+4.2%(8) |
5,661 |
0.0%(9) |
2,730 |
+13.6% |
(1)+18.3 % at CS; (2) +1.2% at
CS; (3) -4.7% at CS;(4)-11.8% at CS; (5) including Generics;
(6)-3.8% at CS; (7) -9.8% at CS; (8) +3.8% at CS;(9)-0.6% at
CS
Pharmaceuticals
First-quarter Pharmaceutical sales
were up 3.1% to €6,262 million mainly driven by the Immunology and
Rare Blood Disorder franchises which were partially offset by
Diabetes and Established Rx Products including the disposal of the
European generics business.
(7) See Appendix 8 for definitions of financial
indicators.
Specialty Care
franchises
Immunology franchise
Net sales (€ million) |
Q1 2019 |
Change
at CER |
Dupixent® |
329 |
+186.9% |
Kevzara® |
30 |
+180.0% |
Total Immunology |
359 |
+186.3% |
Dupixent®
(collaboration with Regeneron) generated sales of €329 million in
the first quarter (up 186.9%). In the U.S., Dupixent®
sales of €266 million (up 157.9%) were driven by continued growth
in adult atopic dermatitis and by the asthma launch. Market access
for Dupixent® in asthma
reached 90% of commercial lives within the first 5 months of
launch. Dupixent® became
commercially available for adolescent atopic dermatitis in
mid-March in the U.S. In April, Dupixent® was launched
in asthma in Japan. First-quarter sales in Europe were €36 million
versus €10 million in the first quarter of 2018.
Kevzara®
(collaboration with Regeneron) sales were €30 million in the first
quarter versus €10 million in the first quarter of 2018, of which
€18 million was in the U.S. (versus €8 million in the first quarter
of 2018).
Multiple
Sclerosis franchise
Net sales (€ million) |
Q1 2019 |
Change
at CER |
Aubagio® |
437 |
+11.9% |
Lemtrada® |
92 |
-15.2% |
Total Multiple Sclerosis |
529 |
+5.9% |
First-quarter Multiple Sclerosis (MS) sales were up 5.9% to €529
million, as double-digit Aubagio® sales growth
was partially offset by the decline in Lemtrada®
sales.
First-quarter Aubagio® sales
increased 11.9% to €437 million, driven by the U.S. (up 12.2% to
€309 million) and Emerging Markets (up 41.7% to €16 million). In
Europe, sales of the product increased 3.2% to €98 million.
In the first quarter, Lemtrada® sales
decreased 15.2% to €92 million due to lower U.S. sales (down 21.3%
to €41 million) and European sales (down 12.8% to €41 million),
reflecting increased competition.
Oncology franchise
Net sales (€ million) |
Q1 2019 |
Change
at CER |
Jevtana® |
111 |
+8.1% |
Thymoglobulin® |
81 |
+11.4% |
Eloxatin® |
54 |
+20.5% |
Taxotere® |
47 |
+7.0% |
Mozobil® |
44 |
+10.5% |
Zaltrap® |
22 |
0.0% |
Others |
40 |
-9.5% |
Total Oncology |
399 |
+7.8% |
First-quarter Oncology sales increased 7.8% to €399 million driven by
China as well as Jevtana®
performance.
Jevtana® sales were up
8.1% to €111 million in the first quarter supported by growth in
all regions. In the first quarter, Thymoglobulin® sales
increased 11.4% (to €81 million) driven by the U.S. (up 10.8% to
€44 million) and China.
In the first quarter, sales of
Eloxatin® (up 20.5% to
€54 million) and Taxotere® (up
7.0% to €47 million) were driven by the strong performance in
China.
Libtayo®
(cemiplimab-rwlc, collaboration with Regeneron) was approved in the
U.S. in September 2018, for the treatment of patients with
metastatic cutaneous squamous cell carcinoma (CSCC) or locally
advanced CSCC who are not candidates for curative surgery or
curative radiation. U.S. Libtayo® sales are
consolidated by Regeneron. Libtayo® was approved
in Brazil at the end of March and in Canada in April.
Rare Disease
franchise
Net sales (€ million) |
Q1 2019 |
Change
at CER |
Myozyme®
/ Lumizyme® |
220 |
+10.7% |
Fabrazyme® |
185 |
+5.9% |
Cerezyme® |
176 |
+6.3% |
Aldurazyme® |
67 |
+31.4% |
Cerdelga® |
48 |
+27.8% |
Others Rare
Disease |
70 |
+3.0% |
Total Rare Disease |
766 |
+10.1% |
In the first quarter, Rare Disease sales increased 10.1% to €766 million,
driven by Gaucher therapies (Cerezyme® and
Cerdelga®),
Myozyme®/Lumizyme® and
Aldurazyme®. In the U.S.
and Europe, first-quarter Rare Disease sales grew 4.5% (to €277
million) and 3.7% (to €255 million), respectively. Emerging Markets
sales were up 37.2% to €153 million reflecting strong performance
supported by favorable timing of orders.
First-quarter Gaucher (Cerezyme®
and Cerdelga®) sales were
up 10.0% to €224 million, supported by the increased penetration of
Cerdelga® in Europe and
the sustained growth of Cerezyme® in Emerging
Markets. First-quarter Cerezyme® sales
increased 6.3% to €176 million and Cerdelga® sales
increased 27.8% to €48 million.
First-quarter Pompe (Myozyme®/Lumizyme®) sales grew
10.7% to €220 million, supported by positive trends in naïve
patient accruals. Over the period, Myozyme®/Lumizyme® sales
increased 14.1% to €79 million in the U.S. and 1.1% to €94 million
in Europe, respectively. In Emerging Markets, sales grew 38.5% to
€32 million driven by Latin America.
First-quarter Fabry (Fabrazyme®) sales
grew 5.9% to €185 million. First-quarter sales in the U.S. and
Europe increased 1.2% (to €94 million) and 7.1% (to €45 million),
respectively. In Emerging Markets, sales of the product grew 16.7%
to €18 million.
Rare Blood Disorder
franchise
Net sales (€ million) |
Q1 2019 |
Change
at CER |
Eloctate® |
174 |
+274.4% |
Alprolix® |
95 |
+319.0% |
Cablivi® |
5 |
- |
Total Rare Blood Disorder |
274 |
+296.9% |
Bioverativ was consolidated in
Sanofi's Financial Statements from March 9, 2018. First-quarter
sales of the Rare Blood Disorder franchise
were €274 million (up 1.2% at CS(8)), including
non-U.S. sales of €67 million with Japan as the primary
contributor.
Eloctate® sales were
€174 million in the first quarter, down 4.2% at CS(9). In the
U.S., sales of the product decreased 7.3% at CS(9), as
share gains in the factor replacement category were more than
offset by the overall increased competitive environment. In
Emerging Markets, first-quarter Eloctate® sales were €4
million reflecting the launch in Taiwan. In the rest of the world,
Eloctate® sales
decreased 3.2% at CS(9) to €33
million, impacted by a decline in sales in Canada following the
previously-announced tender loss.
Alprolix® sales were
€95 million in the first quarter up 6.0% at CS(9), of
which €70 million were generated in the U.S. up 6.6% at
CS(9). In the
rest of the world, Alprolix® sales were
€25 million, an increase of 4.5% at CS(9) as launch
in Australia and growth in Japan was partly offset by a decline in
sales in Canada following the previously-announced tender loss.
Cablivi®
(caplacizumab-yhdp) for the treatment of adults with acquired
thrombotic thrombocytopenic purpura (aTTP), generated sales of €5
million in Germany and France in the first quarter.
Cablivi® was recently
launched in Denmark and Austria. Cablivi® was launched
in the U.S. on April 2, 2019.
(8) Growth comparing first-quarter 2019 sales
versus full first-quarter 2018 sales at CER. Including
Cablivi® sales in
2019. Unaudited data.
(9) Growth comparing first-quarter 2019 sales
versus full first-quarter 2018 sales at CER. Unaudited
data.
Primary Care
franchises
Cardiovascular franchise
Net sales (€ million) |
Q1 2019 |
Change
at CER |
Praluent® |
56 |
+10.2% |
Multaq® |
79 |
-7.6% |
Total cardiovascular
franchise |
135 |
-0.8% |
First-quarter Praluent®
(collaboration with Regeneron) sales increased 10.2% to €56 million
driven by growth in Europe (up 52.6% to €29 million). In the U.S.,
sales decreased 26.9% to €20 million, impacted by significantly
higher rebates. Continued pressure on average U.S. net pricing for
Praluent® is expected
as a result of negotiations to further improve patient access and
affordability throughout 2019.
First-quarter Multaq® sales
decreased 7.6% to €79 million.
Diabetes franchise
Net sales (€ million) |
Q1 2019 |
Change
at CER |
Lantus® |
774 |
-17.2% |
Toujeo® |
211 |
+5.6% |
Total
glargine |
985 |
-13.2% |
Amaryl® |
90 |
+7.2% |
Apidra® |
89 |
-2.2% |
Admelog® |
66 |
+785.7% |
Soliqua® |
22 |
+122.2% |
Insuman® |
21 |
-8.3% |
Other |
21 |
-44.1% |
Total Diabetes |
1,294 |
-6.9% |
First-quarter global Diabetes sales decreased 6.9% to €1,294 million, due to
lower glargine (Lantus® and
Toujeo®) sales in the
U.S. First-quarter U.S. Diabetes sales were down 22.8% to €445
million, reflecting the increased contribution to the coverage gap
related to Part D and a continued decline in average U.S. glargine
net prices. First-quarter sales in Emerging Markets increased 15.3%
to €445 million. First-quarter sales in Europe decreased 5.6% to
€305 million, despite Toujeo® growth (up
19.4%).
In the first quarter, Lantus® sales were
€774 million, down 17.2%. In the U.S., Lantus® sales
decreased 36.6% to €284 million, mainly reflecting lower average
net price and the increased contribution to the coverage gap
related to Part D. In Europe, first-quarter Lantus®
sales were €152 million, down 16.0% due to branded and biosimilar
competition and patients switching to Toujeo®. In
Emerging Markets, first-quarter Lantus® sales were up
14.9% to €281 million.
First-quarter Toujeo® sales were
€211 million, up 5.6%. In the U.S., first-quarter Toujeo®
sales were €69 million, down 24.7% mainly reflecting lower average
net price and the increased contribution to the coverage gap
related to Part D. In Europe and Emerging Markets, first-quarter
Toujeo® sales were
€80 million (up 19.4%) and €44 million (up 64.3%),
respectively.
First-quarter Apidra® sales
decreased 2.2% to €89 million. Lower sales in the U.S. (down 42.9%
to €13 million) offset growth in Emerging Markets (up 33.3% to €34
million).
Amaryl® sales were
€90 million, up 7.2% in the first quarter, of which €79 million
were generated in Emerging Markets (up 8.3%).
Admelog® (insulin
lispro injection) 100 Units/mL generated sales of €66 million in
the first quarter of which €63 million were in the U.S. (versus €6
million in the first quarter of 2018) mainly due to access in
Managed Medicaid.
First-quarter Soliqua® 100/33
(insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL
injection) and Suliqua(TM) sales were €22
million (versus €9 million in the first quarter of 2018). In
February, the FDA approved the expanded use of Soliqua®
100/33 which can now also be prescribed for adults with type 2
diabetes uncontrolled on oral antidiabetic medicines.
Established Rx
Products
Net sales (€ million) |
Q1 2019 |
Change
at CER |
Lovenox® |
343 |
-11.8% |
Plavix® |
404 |
+2.6% |
Aprovel®/Avapro® |
201 |
+15.1% |
Renvela®/Renagel® |
79 |
-25.7% |
Synvisc®
/Synvisc-One® |
68 |
-5.9% |
Myslee®/Ambien®/Stilnox® |
52 |
-18.0% |
Allegra® |
56 |
0.0% |
Generics |
282 |
-33.8% |
Other |
1,021 |
-5.3% |
Total Established Rx Products |
2,506 |
-9.3% |
In the first quarter, Established Rx Products sales decreased 9.3% to €2,506
million, primarily reflecting the divestment of the European
generics business Zentiva at the end of the third quarter of 2018.
Excluding the generics divestment, Established Rx Products sales
decreased 3.8% in the first quarter.
First-quarter Lovenox® sales
decreased 11.8% to €343 million, reflecting lower European sales
(down 21.3% to €192 million) due to biosimilar competition in
several countries. In Emerging Markets, Lovenox® sales
grew 10.4% to €125 million.
In the first quarter, Plavix® sales
increased 2.6% to €404 million, of which €323 million (up 7.1%)
were generated in Emerging Markets. In the first quarter, Aprovel®/Avapro® sales
increased 15.1% to €201 million, of which €146 million (up 18.0%)
were generated in Emerging Markets. In the first quarter,
Plavix® and
Avapro® sales
benefited from continued demand in China ahead of the
implementation of the volume based procurement program in key
cities at the end of the first quarter which is expected to result
in lower growth rates for Plavix® and
Avapro® for full-year
2019. First-quarter Plavix® and
Avapro® sales in
China were €256 million (up 9.1%) and €101 million (up 22.0%),
respectively.
First-quarter Renvela®/Renagel®
(sevelamer) sales decreased 25.7% to €79 million due to generic
competition in the U.S. (down 44.3% to €37 million).
In the first quarter, Generics sales decreased 33.8% to €282 million,
reflecting the divestment of the European generics business Zentiva
at the end of the third quarter of 2018. At CS, first-quarter
Generics sales increased 3.6%. In Emerging Markets, Generics sales
decreased 0.6% to €167 million.
Consumer
Healthcare
CHC sales by geography and
category are provided in Appendix 1.
Net sales (€ million) |
Q1 2019 |
Change at CER |
Allergy Cough & Cold |
362 |
+3.5% |
of which Allegra® |
138 |
+0.8% |
of which Mucosolvan® |
28 |
+3.7% |
of which Xyzal® |
14 |
-7.1% |
Pain |
322 |
+2.5% |
of which Doliprane® |
79 |
-6.0% |
of which Buscopan® |
48 |
0.0% |
Digestive |
271 |
+8.1% |
of which Dulcolax® |
56 |
+3.8% |
of which Enterogermina® |
61 |
+24.5% |
of which Essentiale® |
49 |
+16.3% |
of which Zantac® |
32 |
-3.2% |
Nutritionals |
152 |
-7.9% |
Other |
149 |
-11.8% |
of which Gold Bond® |
52 |
-2.0% |
Total Consumer Healthcare |
1,256 |
+0.6% |
In the first quarter, Consumer Healthcare (CHC) sales increased 0.6% to
€1,256 million, impacted by non-core brand divestments in Europe
and Canada in the course of 2018.
In Europe,
first-quarter CHC sales were down 3.9% to €366 million due to a
weak cough & cold season and non-core brand divestments in the
second quarter of 2018.
In the U.S.,
first-quarter CHC sales decreased 2.1% to €304 million. This
decline mainly reflected the slow start to the allergy season (the
Allergy, Cough & Cold category sales decreased 6.7%).
In Emerging
Markets, first-quarter CHC sales recorded a strong performance,
up 8.1% to €423 million, mainly driven by Latin America,
significant volume growth in Russia as well as a solid performance
of Essentiale in China.
Vaccines
Net sales (€ million) |
Q1 2019 |
Change
at CER |
Polio/Pertussis/Hib
vaccines
(incl. Hexaxim®
/ Hexyon®,
Pentacel®,
Pentaxim® and
Imovax®) |
486 |
+26.1% |
Travel and other
endemic vaccines |
119 |
+13.7% |
Meningitis/Pneumo
vaccines
(incl. Menactra®) |
112 |
+21.3% |
Adult Booster vaccines
(incl. Adacel ®) |
100 |
+5.4% |
Influenza
vaccines
(incl. Vaxigrip®, Fluzone
HD®,
Fluzone®,
Flublok®) |
32 |
+10.3% |
Other vaccines |
24 |
+22.2% |
Total Vaccines |
873 |
+20.1% |
First-quarter Vaccines sales were €873 million, up 20.1% driven by
the performance of Polio/Pertussis/Hib vaccines in Emerging Markets
and Japan. In Emerging Markets, first-quarter Vaccines sales
increased 48.3% and benefited from Pentaxim® in
China and Menactra® performance.
In Europe, first-quarter Vaccines sales were up 5.8% to €146
million. In the U.S., first-quarter Vaccines sales were €272
million (down 3.1%) due to lower Pentacel® sales
reflecting CDC inventory fluctuation.
In the first quarter, Polio/Pertussis/Hib (PPH) vaccines sales increased
26.1% to €486 million, driven by recovery and strong demand for
Pentaxim® in China,
good performance in Emerging Markets and favorable sales phasing in
Japan. In the U.S., PPH vaccines sales decreased 23.4% to €92
million due to lower sales of Pentacel® reflecting
CDC inventory fluctuation.
First-quarter Travel and other endemic vaccines sales increased 13.7%
to €119 million, driven by Rabies vaccines sales in U.S. and
Europe.
First-quarter Menactra® sales
increased 21.3% to €112 million, driven mainly by continued sales
expansion in the Middle East. In the U.S., first-quarter
Menactra® sales
were €74 million (up 1.5%).
First-quarter Adult Booster vaccines sales increased 5.4% to €100
million.
Company sales by
geographic region
Sanofi sales (€ million) |
Q1 2019 |
Change
at CER |
United States |
2,550 |
+7.1% |
Emerging Markets(a) |
2,730 |
+13.6% |
of which Asia |
1,206 |
+17.8% |
of which Latin America |
615 |
+4.6% |
of which Africa, Middle East |
556 |
+12.0% |
of which Eurasia(b) |
312 |
+22.1% |
Europe(c) |
2,187 |
-9.4% |
Rest
of the World(d) |
924 |
+8.3% |
of which Japan |
532 |
+12.6% |
Total Sanofi sales |
8,391 |
+4.2% |
-
World excluding U.S., Canada,
Western & Eastern Europe (except Eurasia), Japan, South Korea,
Australia, New Zealand and Puerto Rico
-
Russia, Ukraine, Georgia,
Belarus, Armenia and Turkey
-
Western Europe + Eastern Europe
except Eurasia
-
Japan, South Korea, Canada,
Australia, New Zealand, Puerto Rico
First-quarter sales in the
U.S. were up 7.1% to €2,550 million. This
mainly reflected the strong performance of Dupixent®, together
with the consolidation of Eloctate® and
Alprolix® sales, which
were partly offset by lower sales of the Diabetes franchise (down
22.8%).
First-quarter sales in Emerging Markets increased 13.6% to €2,730 million,
mainly driven by Vaccines (up 48.3%), Diabetes (up 15.3%), Rare
Disease (up 37.2%), and CHC (up 8.1%). In Asia, sales increased
to €1,206 million (up 17.8%) in the first quarter, reflecting
strong growth in China (up 22.3% to €798 million). In addition to
the recovery and growth in Pentaxim®, sales in
China benefited from continued demand for Plavix® and
Avapro® ahead of
implementation of the volume based procurement program in key
cities at the end of the first quarter which is expected to result
in lower growth rates for Plavix® and
Avapro® for full-year
2019. In Latin America, first-quarter sales increased 4.6% to €615
million. First-quarter sales in Brazil decreased 4.7% to €268
million. In Africa and the Middle East region, first-quarter sales
increased 12.0% to €556 million driven by strong performance of the
Vaccines and Rare Disease franchises. First-quarter sales in the
Eurasia region increased 22.1% to €312 million, driven by growth in
Turkey and Russia (€166 million, up 27.3%).
First-quarter sales in Europe were €2,187 million, down 9.4%, reflecting the
divestment of the European Generics business. At CS, first-quarter
sales were down 3.1% impacted by the decline of Lovenox®.
Sales in Japan increased 12.6% to €532 million in the first
quarter, driven by Dupixent® and favorable
sales phasing of Vaccines (up 90.3%), together with the
consolidation of Eloctate® and
Alprolix® sales.
R&D
update
Consult Appendix 6 for full overview of Sanofi's R&D
pipeline |
Regulatory update
Regulatory updates since February
7, 2019 include the following:
-
In March, the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) adopted a
positive opinion for ZynquistaTM
(sotagliflozin, developed by Sanofi and Lexicon), a dual SGLT1 and
SGLT2 inhibitor, recommending its approval in the European Union
for the treatment of adults with type 1 diabetes. In March, the
U.S. Food and Drug Administration (FDA) issued a Complete Response
Letter regarding the New Drug Application for Zynquista(TM) for the treatment of adults with type 1
diabetes in combination with insulin.
-
In March, Praluent®
(collaboration with Regeneron) was approved in the European Union
to reduce the risk of cardiovascular events in patients with
established cardiovascular disease
-
In March, the U.S. FDA approved Dupixent®
(collaboration with Regeneron) for adolescent patients 12 to 17
years of age with moderate-to-severe atopic dermatitis whose
disease is not adequately controlled with topical prescription
therapies, or when those therapies are not advisable.
-
In March, the U.S. FDA accepted for Priority
Review the supplemental Biologics License Application (sBLA) for
Dupixent® as an add-on
maintenance treatment for adults with inadequately-controlled
severe chronic rhinosinusitis with nasal polyps (CRSwNP). The
target action date for the FDA decision is June 26, 2019.
-
In March, the European Medicines Agency's CHMP
adopted a positive opinion for Dupixent®, recommending
its approval in the European Union for use in adults and
adolescents (12 years and older) as add-on maintenance treatment
for severe asthma with type 2 inflammation characterized by raised
blood eosinophils and/or raised FeNO who are inadequately
controlled with high dose inhaled corticosteroid plus another
medicinal product for maintenance treatment.
-
In the first quarter, the U.S. FDA accepted for
review a supplemental Biologic License Application (sBLA) for
Fluzone® HD
QIV.
At the end of April 2019, the
R&D pipeline contained 84 projects including 32 new molecular
entities in clinical development. 35 projects are in phase 3 or
have been submitted to the regulatory authorities for approval.
Portfolio update
Phase 3:
-
In February, positive results from two phase 3
trials evaluating Dupixent® in
patients with recurring severe CRSwNP were presented at the 2019
Annual Meeting of the American Academy of Allergy, Asthma &
Immunology.
Phase 2:
-
A phase 2b/3 study evaluating Dupixent® in Chronic
Obstructive Pulmonary Disease (COPD) is in the process of being
initiated.
-
A phase 2b study evaluating SAR442168, a BTK inhibitor (collaboration with
Principia), in multiple sclerosis was initiated.
-
A phase 2 study evaluating isatuximab in combination with chemotherapy in
pediatric patients with relapsed refractory acute lymphoblastic
leukemia or acute myeloid leukemia was initiated.
Phase 1:
Collaboration
In April, Sanofi and Alnylam
agreed to conclude the research and option phase of the companies'
2014 RNAi therapeutics alliance in rare genetic diseases. The
material collaboration terms for patisiran, vutrisiran
(ALN-TTRsc02) and fitusiran, as previously announced, will continue
unchanged. As part of this agreement, Alnylam will advance an
additional investigational asset in an undisclosed rare genetic
disease through the end of IND-enabling studies. Sanofi will be
responsible for any potential further development or
commercialization of such asset. In addition, Alnylam and Sanofi
have agreed to amend certain terms of the companies' equity
agreement, with Sanofi obtaining a release of its lock-up of
Alnylam stock holdings, subject to certain trading restrictions,
among other provisions.
2019
first-quarter financial results(10)
Business Net
Income(10)
In the first quarter of 2019,
Sanofi generated net sales of €8,391 million,
an increase of 6.2% (up 4.2% at CER).
First-quarter other revenues increased 41.2% (up 31.6% at CER) to
€322 million, reflecting the VaxServe sales contribution of
non-Sanofi products (€241 million, up 32.0% at CER) and the
royalties received from Swedish Orphan Biovitrum AB.
First-quarter Gross Profit increased 8.7% to €6,097 million (up 6.3%
at CER). The gross margin ratio was 72.7% (72.4% at CER) versus
71.0% in the first quarter of 2018 and benefited from the strong
performance of Vaccines and Pharmaceuticals in China, the growth in
Specialty Care including the contribution from Bioverativ as well
as the end of royalty payments to Bristol-Myers Squibb on
Plavix® and
Avapro®
sales(11). These
positive drivers more than offset the negative impact from U.S.
Diabetes net price evolution and Established Rx Products decrease
in mature markets. In the first quarter of 2019, the gross margin
ratio of segments was 76.0% for Pharmaceuticals (up 1.7 percentage
points), 68.5% for CHC (up 0.7 percentage points) and 62.2% for
Vaccines (up 5.1 percentage points). In 2019, Sanofi expects its
gross margin ratio to be around 70% at CER.
Research and
Development (R&D) expenses increased 8.2% to €1,385 million
in the first quarter of 2019. At CER, R&D expenses increased
4.9%, mainly reflecting the acquisitions of Bioverativ and Ablynx
together with investments in diabetes, rare blood disorder and
immunology programs. Excluding the impact of acquisitions and
Generics in Europe(12), R&D
expenses would have risen by 1.9% at CER in the quarter.
First-quarter selling general and administrative expenses (SG&A)
increased 3.0% to €2,380 million. At CER, SG&A expenses were up
0.6% mainly reflecting consolidation of Bioverativ and Ablynx.
Excluding the impact of acquisitions and Generics in
Europe(12), SG&A
expenses were stable at CER, reflecting investments in Specialty
Care offset by cost efficiency measures notably in Primary Care. In
the first quarter, the ratio of SG&A to sales decreased 0.8
percentage points to 28.4% compared to the first quarter of
2018.
First-quarter operating expenses were €3,765 million, an increase of
4.9% and 2.1% at CER. Excluding the impact of acquisitions and
Generics in Europe(12), operating
expenses would have risen by 0.7% at CER in the first quarter of
2019.
First-quarter other current operating income net
of expenses was -€102 million versus -€31 million in the first
quarter of 2018. This line included the share of profit/loss to
Regeneron of the monoclonal antibodies Alliance net of associated
marketing expenses incurred by Regeneron. In the first quarter of
2019, this line also included a legal contingency provision of €56
million.
The share of
profits from associates was €71 million in the first quarter,
down 4.1%. This line included the contribution of the share of
profits in Regeneron.
In the first quarter, non-controlling interests were -€10 million versus -€30
million and reflected the restructuring of the Alliance with
Bristol-Myers Squibb related to Plavix® and
Avapro®.
First-quarter business operating income increased 12.6% to €2,291
million. At CER, business operating income increased 11.3%. The
ratio of business operating income to net sales increased 1.5
percentage points to 27.3% versus the first quarter of 2018. Over
the period, the business operating income ratio of segments was
38.2% for Pharmaceuticals (up 0.7 percentage points), 34.9% for CHC
(up 0.7 percentage points) and 27.1% for Vaccines (up 9.1
percentage points).
Net financial
expenses were -€45 million in the first quarter versus €2
million in the same period of 2018. Net financial expenses included
a gain of €76 million in the first quarter of 2018. In the first
quarter of 2019, net financial expenses included the cost
associated with the Bioverativ and Ablynx acquisitions. A €26
million financial gain was also recognized in connection with
contingent payments on future regulatory milestones.
The first-quarter effective tax rate was
stable at 22%. Sanofi expects its effective tax rate to be around
22% in 2019.
First-quarter business net income(10) increased
10.5% to €1,765 million and 9.0% at CER. The ratio of business net
income to net sales was 21.0%, up 0.8 percentage points compared
with the first quarter of 2018.
(10) See Appendix
3 for 2019 first-quarter consolidated income statement; see
Appendix 8 for definitions of financial indicators, and Appendix 4
for reconciliation of IFRS net income reported to business net
income.
(11) Excluding the U.S. and Puerto
Rico
(12) Excluding Bioverativ and Ablynx
acquisitions and European Generics business
In the first
quarter of 2019, business earnings per
share(10) (EPS)
increased 10.9% to €1.42 and 9.4% at CER. The average number of
shares outstanding was 1,245.8 million in the first quarter of 2019
versus 1,248.2 million in the first quarter of 2018. |
Reconciliation of
IFRS net income reported to business net income (see Appendix
4)
In Q1 2019, the IFRS net income
was €1,137 million. The main items excluded from the business net
income were:
- An amortization charge of €557
million related to fair value remeasurement on intangible assets of
acquired companies (primarily Genzyme: €186 million, Bioverativ:
€135 million, Boehringer Ingelheim CHC business: €61 million,
Aventis: €54 million) and to acquired intangible assets
(licenses/products: €30 million). These items have no cash impact
on the Company.
- Restructuring costs and similar
items of €321 million mainly related to streamlining initiatives in
Europe.
- A charge of €4 million related to
the effects of IFRS 16 on Lease accounting(11).
- A €227 million tax effect arising
from the items listed above, mainly comprising €138 million of
deferred taxes generated by amortization and impairments of
intangible assets, and €95 million associated with restructuring
costs and similar items. (see Appendix 4).
- An income of €25 million net of
tax related to restructuring costs of associates and joint
ventures, and expenses arising from the impact of acquisitions on
associates and joint ventures.
Capital
Allocation
In the first quarter of 2019, net
cash generated by operating activities increased 49.0% to €1,234
million after capital expenditures of €381 million and an increase
in working capital of €651 million. In the first quarter of 2019,
restructuring costs and similar items were €491 million and
disposals net of acquisitions and partnerships were €74 million. As
a consequence, net debt decreased from €17,628 million at December
31, 2018, to €16,767 million at March 31, 2019 (amount net of
€9,095 million in cash and cash equivalents).
(10) See Appendix
3 for 2019 first-quarter consolidated income statement; see
Appendix 8 for definitions of financial indicators, and Appendix 4
for reconciliation of IFRS net income reported to business net
income.
(11) Impact of new lease standard IFRS 16, is
effective January 1, 2019 using the modified retrospective
transition method (no restatement of prior periods), since Business
Net Income remains reported as previously under IAS 17 and related
interpretations for comparison purposes.
Forward-Looking
Statements
This press release 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, to
complete related transactions 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, 2018. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
Appendices
List of appendices
Appendix 1: |
2019
first-quarter net sales by GBU, franchise, geographic region and
product |
Appendix 2: |
2019 first-quarter business net income statement |
Appendix 3: |
2019 first-quarter consolidated income statement |
Appendix 4: |
Reconciliation of IFRS net income reported to business
net income |
Appendix 5:
Appendix 6:
Appendix 7: |
Currency sensitivity
R&D pipeline
Expected R&D milestones |
Appendix 8: |
Definitions of non-GAAP financial indicators |
Appendix 1: 2019 first-quarter
net sales by GBU, franchise, geographic region and product
Q1 2019
(€ million) |
Total
GBUs |
% CER |
% reported |
Europe |
% CER |
United States |
% CER |
Rest of the World |
% CER |
Emerging Markets |
% CER |
Total
Franchises |
% CER |
% reported |
Aubagio |
421 |
10 .9% |
17 .3% |
98 |
3 .2% |
309 |
12 .2% |
14 |
50 .0% |
16 |
41 .7% |
437 |
11 .9% |
17 .8% |
Lemtrada |
86 |
-18 .0% |
-14 .0% |
41 |
-12 .8% |
41 |
-21 .3% |
4 |
-33 .3% |
6 |
40 .0% |
92 |
-15 .2% |
-12
.4% |
Total MS |
507 |
4 .6% |
10 .5% |
139 |
-2 .1% |
350 |
7 .0% |
18 |
18 .8% |
22 |
41 .2% |
529 |
5 .9% |
11 .1% |
Cerezyme |
113 |
-5 .2% |
-2 .6% |
63 |
-4 .5% |
43 |
-4 .9% |
7 |
-11 .1% |
63 |
28 .8% |
176 |
6 .3% |
0 .6% |
Cerdelga |
47 |
22 .2% |
30 .6% |
16 |
60 .0% |
28 |
8 .3% |
3 |
0 .0% |
1 |
- |
48 |
27 .8% |
33 .3% |
Myozyme |
188 |
6 .5% |
10 .6% |
94 |
1 .1% |
79 |
14 .1% |
15 |
7 .7% |
32 |
38 .5% |
220 |
10 .7% |
12 .2% |
Fabrazyme |
167 |
4 .6% |
9 .9% |
45 |
7 .1% |
94 |
1 .2% |
28 |
12 .5% |
18 |
16 .7% |
185 |
5 .9% |
8 .8% |
Aldurazyme |
39 |
8 .8% |
14 .7% |
20 |
5 .3% |
12 |
10 .0% |
7 |
20 .0% |
28 |
76 .5% |
67 |
31 .4% |
31 .4% |
Total Rare Disease |
613 |
3 .9% |
8 .3% |
255 |
3 .7% |
277 |
4 .5% |
81 |
2 .7% |
153 |
37 .2% |
766 |
10 .1% |
10 .2% |
Jevtana |
105 |
6 .4% |
11 .7% |
42 |
5 .0% |
47 |
4 .9% |
16 |
15 .4% |
6 |
40 .0% |
111 |
8 .1% |
12 .1% |
Mozobil |
42 |
11 .1% |
16 .7% |
11 |
-8 .3% |
26 |
14 .3% |
5 |
66 .7% |
2 |
0 .0% |
44 |
10 .5% |
15 .8% |
Thymoglobulin |
58 |
5 .9% |
13 .7% |
9 |
0 .0% |
44 |
10 .8% |
5 |
-20 .0% |
23 |
26 .3% |
81 |
11 .4% |
15 .7% |
Taxotere |
7 |
-12 .5% |
-12 .5% |
1 |
0 .0% |
0 |
- |
6 |
-14 .3% |
40 |
11 .4% |
47 |
7 .0% |
9 .3% |
Eloxatine |
6 |
-14 .3% |
-14 .3% |
0 |
-100 .0% |
0 |
- |
6 |
0 .0% |
48 |
27 .0% |
54 |
20 .5% |
22 .7% |
Total Oncology |
273 |
2 .4% |
7 .5% |
88 |
-1 .1% |
137 |
3 .3% |
48 |
7 .0% |
126 |
21 .2% |
399 |
7 .8% |
11 .5% |
Dupixent |
326 |
184 .1% |
204 .7% |
36 |
260 .0% |
266 |
157 .9% |
24 |
- |
3 |
- |
329 |
186 .9% |
207
.5% |
Kevzara |
30 |
180 .0% |
200 .0% |
8 |
300 .0% |
18 |
112 .5% |
4 |
- |
0 |
- |
30 |
180 .0% |
200
.0% |
Total immunology |
356 |
183 .8% |
204 .3% |
44 |
266 .7% |
284 |
154 .4% |
28 |
- |
3 |
- |
359 |
186 .3% |
206 .8% |
Alprolix |
95 |
319 .0% |
352 .4% |
0 |
- |
70 |
306 .3% |
25 |
360 .0% |
0 |
- |
95 |
319 .0% |
352
.4% |
Eloctate |
170 |
265 .1% |
295 .3% |
0 |
- |
137 |
262 .9% |
33 |
275 .0% |
4 |
- |
174 |
274 .4% |
304
.7% |
Cablivi |
5 |
- |
- |
5 |
- |
0 |
- |
0 |
- |
0 |
- |
5 |
- |
- |
Total Rare Blood Disorder |
270 |
290 .6% |
321 .9% |
5 |
- |
207 |
276 .5% |
58 |
307 .7% |
4 |
- |
274 |
296 .9% |
328 .1% |
Sanofi Genzyme (Specialty Care) |
2,019 |
30 .8% |
38 .3% |
531 |
8 .6% |
1,255 |
40 .8% |
233 |
48 .6% |
308 |
33 .6% |
2,327 |
31 .2% |
36 .1% |
Lantus |
493 |
-29 .3% |
-25 .6% |
152 |
-16 .0% |
284 |
-36 .6% |
57 |
-20 .3% |
281 |
14 .9% |
774 |
-17 .2% |
-15
.0% |
Toujeo |
167 |
-4 .1% |
-1 .2% |
80 |
19 .4% |
69 |
-24 .7% |
18 |
5 .9% |
44 |
64 .3% |
211 |
5 .6% |
7 .1% |
Apidra |
55 |
-17 .2% |
-14 .1% |
33 |
-5 .7% |
13 |
-42 .9% |
9 |
0 .0% |
34 |
33 .3% |
89 |
-2 .2% |
-2 .2% |
Amaryl |
11 |
0 .0% |
0 .0% |
4 |
0 .0% |
0 |
- |
7 |
0 .0% |
79 |
8 .3% |
90 |
7 .2% |
8 .4% |
Admelog |
66 |
785 .7% |
842 .9% |
3 |
200 .0% |
63 |
883 .3% |
0 |
- |
0 |
- |
66 |
785 .7% |
842
.9% |
Total Diabetes |
849 |
-15 .9% |
-11 .9% |
305 |
-5 .6% |
445 |
-22 .8% |
99 |
-12 .1% |
445 |
15 .3% |
1,294 |
-6 .9% |
-4 .6% |
Praluent |
52 |
6 .4% |
10 .6% |
29 |
52 .6% |
20 |
-26 .9% |
3 |
0 .0% |
4 |
100 .0% |
56 |
10 .2% |
14 .3% |
Multaq |
77 |
-7 .8% |
0 .0% |
10 |
-9 .1% |
66 |
-7 .6% |
1 |
- |
2 |
0 .0% |
79 |
-7 .6% |
0 .0% |
Total Cardiovascular |
129 |
-2 .4% |
4 .0% |
39 |
30 .0% |
86 |
-13 .0% |
4 |
0 .0% |
6 |
50 .0% |
135 |
-0 .8% |
5 .5% |
Plavix |
81 |
-12 .2% |
-10 .0% |
34 |
-10 .5% |
0 |
- |
47 |
-13 .5% |
323 |
7 .1% |
404 |
2 .6% |
4 .4% |
Lovenox |
218 |
-21 .0% |
-21 .0% |
192 |
-21 .3% |
9 |
-25 .0% |
17 |
-15 .0% |
125 |
10 .4% |
343 |
-11 .8% |
-12
.3% |
Renagel /
Renvela |
58 |
-37 .2% |
-32 .6% |
13 |
-18 .8% |
37 |
-44 .3% |
8 |
-22 .2% |
21 |
40 .0% |
79 |
-25 .7% |
-21
.8% |
Aprovel |
55 |
8 .0% |
10 .0% |
27 |
-3 .6% |
7 |
200 .0% |
21 |
5 .0% |
146 |
18 .0% |
201 |
15 .1% |
16 .9% |
Synvisc /
Synvisc one |
53 |
-10 .9% |
-3 .6% |
6 |
16 .7% |
44 |
-11 .1% |
3 |
-50 .0% |
15 |
15 .4% |
68 |
-5 .9% |
0 .0% |
Allegra |
56 |
0 .0% |
7 .7% |
2 |
0 .0% |
0 |
- |
54 |
0 .0% |
0 |
- |
56 |
0 .0% |
7 .7% |
Stilnox |
35 |
-23 .3% |
-18 .6% |
8 |
-27 .3% |
7 |
-40 .0% |
20 |
-13 .6% |
17 |
-5 .6% |
52 |
-18 .0% |
-14
.8% |
Depakine |
43 |
-4 .4% |
-4 .4% |
40 |
-4 .8% |
0 |
- |
3 |
0 .0% |
77 |
11 .6% |
120 |
5 .3% |
5 .3% |
Tritace |
35 |
-2 .7% |
-5 .4% |
34 |
-5 .6% |
0 |
- |
1 |
100 .0% |
18 |
-10 .0% |
53 |
-5 .3% |
-7 .0% |
Generics |
115 |
-57 .0% |
-55 .1% |
30 |
-83 .7% |
37 |
47 .8% |
48 |
-6 .1% |
167 |
-0 .6% |
282 |
-33 .8% |
-35
.2% |
Other other
Rx |
558 |
-5 .9% |
-5 .9% |
414 |
-7 .1% |
47 |
-14 .0% |
97 |
4 .2% |
290 |
-8 .0% |
848 |
-6 .7% |
-7 .5% |
Total Established Rx Products |
1,307 |
-18 .8% |
-17 .4% |
800 |
-23 .9% |
188 |
-15 .3% |
319 |
-4 .3% |
1,199 |
3 .5% |
2,506 |
-9 .3% |
-9 .0% |
Primary Care |
2,285 |
-17 .0% |
-14 .5% |
1,144 |
-18 .5% |
719 |
-19 .9% |
422 |
-6 .2% |
1,650 |
6 .6% |
3,935 |
-8 .3% |
-7 .2% |
China and Emerging Markets |
1,958 |
10 .3% |
7 .7% |
|
|
|
|
|
|
1,958 |
10 .3% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Pharmaceuticals |
6,262 |
3 .1% |
5 .3% |
1,675 |
-11 .5% |
1,974 |
10 .4% |
655 |
7 .7% |
1,958 |
10 .3% |
6,262 |
3 .1% |
5 .3% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy,
Cough and Cold |
362 |
3 .5% |
6 .2% |
101 |
1 .0% |
107 |
-6 .7% |
60 |
7 .4% |
94 |
17 .1% |
362 |
3 .5% |
6 .2% |
Pain |
322 |
2 .5% |
-0 .6% |
129 |
-1 .5% |
45 |
10 .8% |
29 |
3 .7% |
119 |
3 .9% |
322 |
2 .5% |
-0 .6% |
Digestive |
271 |
8 .1% |
9 .3% |
85 |
1 .2% |
49 |
-6 .3% |
13 |
0 .0% |
124 |
21 .4% |
271 |
8 .1% |
9 .3% |
Nutritional |
152 |
-7 .9% |
-7 .3% |
33 |
3 .0% |
10 |
0 .0% |
52 |
-13 .8% |
57 |
-9 .4% |
152 |
-7 .9% |
-7 .3% |
Consumer Healthcare |
1,256 |
0 .6% |
1 .5% |
366 |
-3 .9% |
304 |
-2 .1% |
163 |
-2 .5% |
423 |
8 .1% |
1,256 |
0 .6% |
1 .5% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio /
Pertussis / Hib |
486 |
26 .1% |
27 .9% |
73 |
1 .4% |
92 |
-23 .4% |
77 |
80 .5% |
244 |
58 .0% |
486 |
26 .1% |
27 .9% |
Adult
Booster Vaccines |
100 |
5 .4% |
8 .7% |
36 |
-2 .7% |
51 |
14 .6% |
6 |
0 .0% |
7 |
0 .0% |
100 |
5 .4% |
8 .7% |
Meningitis/
Pneumonia |
112 |
21 .3% |
25 .8% |
0 |
- |
74 |
1 .5% |
3 |
-25 .0% |
35 |
105 .6% |
112 |
21 .3% |
25 .8% |
Influenza
Vaccines |
32 |
10 .3% |
10 .3% |
1 |
0 .0% |
2 |
-50 .0% |
3 |
-40 .0% |
26 |
36 .8% |
32 |
10 .3% |
10 .3% |
Travel and
other Endemic Vaccines |
119 |
13 .7% |
16 .7% |
34 |
25 .9% |
33 |
40 .9% |
14 |
-13 .3% |
38 |
0 .0% |
119 |
13 .7% |
16 .7% |
Vaccines |
873 |
20 .1% |
22 .8% |
146 |
5 .8% |
272 |
-3 .1% |
106 |
36 .0% |
349 |
48 .3% |
873 |
20 .1% |
22 .8% |
Total Company |
8,391 |
4 .2% |
6 .2% |
2,187 |
-9 .4% |
2,550 |
7 .1% |
924 |
8 .3% |
2,730 |
13 .6% |
8,391 |
4 .2% |
6 .2% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Appendix 2:
Business net income statement
First quarter 2019 |
Pharmaceuticals |
Consumer
Healthcare |
Vaccines |
Others (1) |
Total Group |
€
million |
Q1 2019 |
Q1 2018 |
Change |
Q1 2019 |
Q1 2018 |
Change |
Q1 2019 |
Q1 2018 |
Change |
Q1 2019 |
Q1 2018 |
Change |
Q1 2019 |
Q1 2018 |
Change |
Net sales |
6 ,262 |
5 ,949 |
5
.3% |
1 ,256 |
1 ,238 |
1
.5% |
873 |
711 |
22
.8% |
- |
- |
- |
8 ,391 |
7 ,898 |
6
.2% |
Other revenues |
80 |
58 |
37 .9% |
- |
- |
- |
242 |
170 |
42 .4% |
- |
- |
- |
322 |
228 |
41 .2% |
Cost of sales |
(1 ,581) |
(1 ,587) |
(0 .4%) |
(396) |
(399) |
(0 .8%) |
(572) |
(475) |
20 .4% |
(67) |
(54) |
24 .1% |
(2 ,616) |
(2
,515) |
4 .0% |
As %
of net sales |
(25 .2%) |
(26 .7%) |
|
(31 .5%) |
(32 .2%) |
|
(65 .5%) |
(66 .8%) |
|
|
|
|
(31 .2%) |
(31 .8%) |
|
Gross profit |
4 ,761 |
4 ,420 |
7
.7% |
860 |
839 |
2
.5% |
543 |
406 |
33
.7% |
(67) |
(54) |
24
.1% |
6 ,097 |
5 ,611 |
8
.7% |
As % of net sales |
76
.0% |
74
.3% |
|
68
.5% |
67
.8% |
|
62
.2% |
57 .1% |
|
|
|
|
72
.7% |
71 .0% |
|
Research &
Development expenses |
(1 ,073) |
(978) |
9 .7% |
(35) |
(28) |
25 .0% |
(133) |
(126) |
5 .6% |
(144) |
(148) |
(2 .7%) |
(1 ,385) |
(1
,280) |
8 .2% |
As %
of net sales |
(17 .1%) |
(16 .4%) |
|
(2 .8%) |
(2 .3%) |
|
(15 .2%) |
(17 .7%) |
|
|
|
|
(16 .5%) |
(16 .2%) |
|
Selling and general
expenses |
(1 ,275) |
(1 ,254) |
1 .7% |
(394) |
(389) |
1 .3% |
(173) |
(153) |
13 .1% |
(538) |
(514) |
4 .7% |
(2 ,380) |
(2
,310) |
3 .0% |
As %
of net sales |
(20 .4%) |
(21 .1%) |
|
(31 .4%) |
(31 .4%) |
|
(19 .8%) |
(21 .5%) |
|
|
|
|
(28 .4%) |
(29 .2%) |
|
Other current
operating income/ expenses |
(87) |
(7) |
|
11 |
5 |
|
- |
2 |
|
(26) |
(31) |
|
(102) |
(31) |
|
Share of profit/loss
of associates* and joint-ventures |
71 |
75 |
|
- |
- |
|
- |
(1) |
|
- |
- |
|
71 |
74 |
|
Net income
attributable to non-controlling interests |
(6) |
(26) |
|
(4) |
(4) |
|
- |
- |
|
- |
- |
|
(10) |
(30) |
|
Business operating income |
2 ,391 |
2 ,230 |
7
.2% |
438 |
423 |
3
.5% |
237 |
128 |
85
.2% |
(775) |
(747) |
3
.7% |
2 ,291 |
2 ,034 |
12
.6% |
As % of net sales |
38
.2% |
37
.5% |
|
34
.9% |
34
.2% |
|
27
.1% |
18 .0% |
|
|
|
|
27
.3% |
25 .8% |
|
|
|
|
|
|
|
|
Financial
income and expenses |
(45) |
2 |
|
|
|
|
|
|
|
|
Income tax
expenses |
(481) |
(438) |
|
|
|
|
|
|
|
|
Tax rate** |
22 .0% |
22 .0% |
|
|
|
|
|
|
|
|
Business net income |
1 ,765 |
1 ,598 |
10
.5% |
|
|
|
|
|
|
|
As % of net sales |
21
.0% |
20 .2% |
|
|
|
|
|
|
|
|
Business earnings / share (in
euros) *** |
1 .42 |
1 .28 |
10
.9% |
* Net of
tax.
** Determined on the basis of Business
income before tax, associates and non-controlling
interests.
*** Based on an average number of shares
outstanding of 1,245.8 million in the first quarter of 2019 and
1,248.2 million in the first quarter of 2018.
(1)
Other includes the cost of global support functions (Medical
Affairs, External Affairs, Finance, Human Resources, Information
Solution & Technologies, Sanofi Business Services, etc).
Appendix 3: Consolidated income
statements
€ million |
Q1 2019 |
Q1 2018 |
Net
sales |
8,391 |
7,898 |
Other revenues |
322 |
228 |
Cost of sales |
(2,618) |
(2,545) |
Gross
profit |
6,095 |
5,581 |
Research and
development expenses |
(1,385) |
(1,280) |
Selling and general
expenses |
(2,376) |
(2,312) |
Other operating
income |
64 |
25 |
Other operating
expenses |
(166) |
(56) |
Amortization of
intangible assets |
(557) |
(458) |
Impairment of
intangible assets |
(5) |
(3) |
Fair value
remeasurement of contingent consideration |
60 |
(56) |
Restructuring costs
and similar items |
(321) |
(191) |
Other gains and losses
and litigation(1) |
- |
(49) |
Operating income |
1,409 |
1,201 |
Financial
expenses |
(106) |
(95) |
Financial income |
52 |
97 |
Income before tax and associates and joint
ventures |
1,355 |
1,203 |
Income tax
expense |
(255) |
(187) |
Share of profit/loss
of associates and joint ventures |
47 |
30 |
Net
income excluding the held for exchange Animal Health
business |
1,147 |
1,046 |
Net income from the
held for exchange Animal Health business |
- |
(1) |
Net
income |
1,147 |
1,045 |
Net income
attributable to non-controlling interests |
10 |
29 |
Net
income attributable to equity holders of Sanofi |
1,137 |
1,016 |
Average number of
shares outstanding (million) |
1,245.8 |
1,248.2 |
Earnings per share (in euros) excluding the held
for exchange Animal Health business |
0.91 |
0.81 |
IFRS earnings per share (in euros) |
0.91 |
0.81 |
-
In 2018, separation costs for the European
Generics business divestiture.
Appendix 4: Reconciliation of Net
income attributable to equity holders of Sanofi to Business net
income
€ million |
Q1 2019 |
Q1 2018 |
Variation |
|
Net
income attributable to equity holders of Sanofi |
1,137 |
1,016 |
11.9% |
|
Amortization of
intangible assets(1) |
557 |
458 |
|
|
Impairment of
intangible assets |
5 |
3 |
|
|
Fair value
remeasurement of contingent consideration |
(60) |
56 |
|
|
Expenses arising from
the impact of business combinations on inventories |
3 |
30 |
|
|
Other expenses related
to business combinations |
- |
2 |
|
|
Restructuring costs
and similar items |
321 |
191 |
|
|
Other gains and
losses, and litigation (2) |
- |
49 |
|
|
Effects of IFRS 16 on
Lease accounting (3) |
4 |
- |
|
|
Tax effect of items
listed above: |
(227) |
(185) |
|
|
Amortization & impairment of intangible assets |
(138) |
(122) |
|
|
Fair
value remeasurement of contingent consideration |
(4) |
(6) |
|
|
Expenses arising from the impact of business combinations
on inventories |
- |
(6) |
|
|
Other
expenses related to business combinations |
- |
(1) |
|
|
Restructuring costs and similar items |
(95) |
(52) |
|
|
Other
tax effects |
10 |
2 |
|
|
Other tax ítems
(4) |
- |
(66) |
|
|
Share of items listed
above attributable to non-controlling interests |
- |
(1) |
|
|
Restructuring costs of
associates and joint-ventures, and expenses arising from the impact
of acquisitions on associates and joint-ventures |
25 |
44 |
|
|
Animal Health
items |
- |
1 |
|
|
Business net income |
1,765 |
1,598 |
10.5% |
|
IFRS earnings per
share(5) (in
euros) |
0.91 |
0.81 |
|
- Of which related to amortization expense
generated by the remeasurement of intangible assets as part of
business combinations: €527 million in the first quarter of
2019 and €425 million in the first quarter of 2018.
- In 2018, separation costs for the European
Generics business divestiture.
- Impact of new lease standard IFRS 16, is
effective January 1, 2019 using the modified retrospective
transition method (no restatement of prior periods), since
Business Net Income remains reported as previously under IAS 17 and
related interpretations for comparison purposes.
- In 2018, mainly due to US tax reform.
- Based on an average number of shares outstanding
of 1,245.8 million in the first quarter of 2019 and 1,248.2 million
in the first quarter of 2018.
Appendix 5 : currency
sensitivity
2019 Business EPS currency
sensitivity
Currency |
Variation |
Business EPS
Sensitivity |
U.S. Dollar |
+0.05
USD/EUR |
-EUR 0.10 |
Japanese Yen |
+5
JPY/EUR |
-EUR 0.02 |
Chinese Yuan |
+0.2
CNY/EUR |
-EUR 0.02 |
Brazilian Real |
+0.4
BRL/EUR |
-EUR 0.01 |
Russian
Ruble |
+10
RUB/EUR |
-EUR
0.03 |
Currency exposure on Q1 2019
sales
Currency |
Q1 2019 |
US
$ |
31.5% |
Euro
€ |
23.0% |
Chinese Yuan |
9.4% |
Japanese Yen |
6.1% |
Brazilian Real |
3.1% |
Russian Ruble |
1.9% |
British Pound |
1.8% |
Canadian $ |
1.5% |
Australian $ |
1.3% |
Mexican Peso |
1.2% |
Others |
19.2% |
Currency average rates
|
Q1 2018 |
Q1 2019 |
Change |
€/$ |
1.23 |
1.14 |
-7.6% |
€/Yen |
133.16 |
125.12 |
-6.0% |
€/Yuan |
7.81 |
7.67 |
-1.8% |
€/Real |
3.99 |
4.28 |
+7.2% |
€/Ruble |
69.93 |
74.91 |
+7.1% |
Appendix 6: R&D
Pipeline
|
Immuno-inflammation |
|
Rare
Blood Disorders |
|
Cardiovascular & metabolism |
|
Oncology |
|
MS &
Neuro |
|
Vaccines |
|
Rare
Diseases |
|
Diabetes |
|
|
New Molecular
Entities(*)
Phase 1
(Total : 17) |
Phase 2
(Total : 8) |
Phase 3
(Total : 7) |
Registration
(Total : 2) |
SAR441344(**)
(1)
Anti-CD40L mAb
Multiple Sclerosis |
BIVV001(**)
(5)
rFVIIIFc - vWF - XTEN(6)
Hemophilia A |
SAR440340(**)
(12)
Anti-IL33 mAb
Atopic Dermatitis |
SAR422459(**)
(14) ABCA4 gene therapy
Stargardt Disease |
isatuximab Anti-CD38 mAb
3L RRMM (ICARIA) |
cemiplimab(**)
(12)
PD-1 inhibitor mAb
Advanced CSCC (EU) |
SAR408701 Maytansin-loaded anti-CEACAM5 mAb, Solid Tumors |
ST400(**)
(7) Ex Vivo ZFN Gene-Edited Cell
Therapy, Beta thalassemia |
SAR156597 IL4/IL13 bispecific
mAb
Systemic Scleroderma |
SAR442168(**)
(15)
BTK inhibitor
Multiple Sclerosis |
avalglucosidase
alfa
Neo GAA
Pompe Disease |
ZynquistaTM(**)
(20)
Oral SGLT-1&2 inhibitor
Type 1 Diabetes (U.S./EU) |
SAR439459 anti-TGFb mAb
Advanced Solid Tumors |
BIVV003(**)
(7) Ex Vivo ZFN Gene-Edited Cell
Therapy, Sickle Cell Disease |
R
|
olipudase
alfa rhASM
AS Deficiency(13) |
HIV Viral vector prime & rgp120 boost vaccine |
venglustat
Oral GCS inhibitor
ADPKD(17) |
|
|
O
|
REGN5458(**)
(2)
Anti-BCMA-CD3 bispecific mAb
Relapsing Refractory MM |
SAR443060(**)
(8)
RIPK1 inh(9)
Amyotrophic Lateral Sclerosis |
SAR339375
miRNA-21
Alport Syndrome |
SP0232(**)
(16) Respiratory
syncytial virus
Monoclonal Antibody |
fitusiran RNAi targeting anti-thrombin
Hemophilia A and B |
|
|
O
|
REGN4018(**)
(2)
Anti-MUC16-CD3 bispecific mAb
Ovarian Cancer |
Next Gen PCV(**)
(10)
Pneumococcal Conjugate
Vaccines |
|
|
sutimlimab(18)
Anti Complement C1s mAb
Cold Agglutinin Disease |
|
|
SAR439859 SERD
Metastatic Breast Cancer |
Herpes Simplex Virus Type
2 HSV-2 therapeutic vaccine |
|
|
SAR341402 Rapid acting insulin
Type 1/2 Diabetes |
|
SAR442720(**)
(3) SHP2 inhibitor
Solid Tumors |
Respiratory syncytial
virus Infants 4-month and older
Vaccines |
|
|
efpeglenatide(**)
(19) Long-acting
GLP-1 agonist
Type 2 Diabetes |
|
SAR440234 T cell engaging multi spe mAb
Leukemia |
SAR441169(**)
(11)
RORC (ROR gamma T) antagonist, Psoriasis |
|
|
|
|
SAR441000(**)
(4)
Cytokine mRNA
Solid tumor |
|
|
|
|
|
O : Opt-in rights products for which rights have
not been exercised yet
R : Registrational Study (other than
Phase 3)
(*) Phase of projects determined by clinicaltrials.gov
disclosure timing
|
-
Developed in collaboration with Immunext
-
Regeneron product for which Sanofi has opt-in
rights
-
Developed in collaboration with REVOLUTION
Medicines
-
Developed in collaboration with BioNtech
-
Sanofi product for which Sobi has opt-in rights
in SOBI territories
-
Recombinant Coagulation Factor VIII Fc - von
Willebrand Factor - XTEN Fusion protein
-
Developed in collaboration with Sangamo
-
Developed in collaboration with Denali
-
Receptor-interacting serine/threonine-protein
kinase 1
-
Developed in collaboration with SK
-
Developed in collaboration with Lead
Pharma
-
Developed in collaboration with Regeneron
-
Acid Sphingomyelinase Deficiency also known as
Niemann Pick type B
-
Identification of out-licensing partner
ongoing
-
Developed in collaboration with Principia
-
Developed in collaboration with
AstraZeneca
-
Autosomal Dominant Polycystic Kidney
Disease
-
Also known as BIVV009
-
Developed in collaboration with Hanmi
-
Developed in collaboration with Lexicon
(**) Partnered and/or in collaboration - Sanofi
may have limited or shared rights on some of these products |
Additional
Indications(*)
Phase 1
(Total : 5) |
Phase 2
(Total : 19) |
Phase 3
(Total : 21) |
Registration
(Total : 5) |
SAR439459 +
cemiplimab(**)
(1) Anti-TGFb mAb + PD-1 inh
mAb
Advanced Solid Tumors |
dupilumab(**)
(1) Anti-IL4Ralpha mAb
Grass Immunotherapy |
isatuximab +
cemiplimab(**)
(1) Anti-CD38 mAb + PD-1 inh
mAb
Relapsing Refractory MM |
dupilumab(**)
(1) Anti-IL4Ralpha mAb
Asthma 6 - 11 years old |
isatuximab
Anti-CD38 mAb
Newly Diag. MM Te(9) (GMMG) |
dupilumab(**)
(1) Anti-IL4Ralpha mAb
Asthma 12y+ (EU) |
O
|
cemiplimab(**)
(1) + REGN4018(2)
PD-1 inh mAb + Anti-MUC16-CD3 bispe mAb - Ovarian Cancer |
R
|
sarilumab(**)
(1) Anti-IL6R mAb
Polyarticular JIA(6) |
isatuximab +
cemiplimab(**)
(1) Anti-CD38 mAb + PD-1 inh
mAb
Advanced Malignancies |
dupilumab(**)
(1) Anti-IL4Ralpha mAb
Eosinophilic Esophagitis |
isatuximab Anti-CD38 mAb
1-3L RRMM (IKEMA) |
Dupixent®(**)
(1)
dupilumab
AD 12 - 17 years old (EU) |
|
|
SAR439859 + palbociclib
SERD + CDK4/6 inh
Metastatic Breast Cancer |
sarilumab(**)
(1) Anti-IL6R
mAb
Systemic Juvenile Arthritis |
isatuximab +
cemiplimab(**)
(1) Anti-CD38 mAb + PD-1 inh
mAb
Lymphoma |
Dupixent®(**)
(1) dupilumab
AD 6 - 11 years old |
Aubagio® teriflunomide
RMS - Pediatric |
dupilumab(**)
(1) Anti-IL4Ralpha mAb
CRSwNP |
sutimlimab(3) Anti Complement C1s mAb
ImmuneThrombocytopenic Purpura |
SAR440340(**)
(1) Anti-IL33 mAb
COPD |
isatuximab +
atezolizumab(7) Anti-CD38 mAb + PD-L1 inh mAb
mCRC |
Dupixent®(**)
(1)
dupilumab
AD 6 months - 5 years old |
Lemtrada® alemtuzumab
RRMS - Pediatric |
Praluent®(**)
(1)
alirocumab
CV events reduction (U.S.) |
SAR443060(4)
RIPK1 inh(5)
Alzheimer's Disease |
dupilumab(**)
(1) + AR101 Anti-IL4Ralpha mAb +
Immunotherapy
Peanut Allergy - Pediatric |
isatuximab +
atezolizumab(7) Anti-CD38 mAb + PD-L1 inhibitor mAb
Solid Tumors |
sarilumab(**)
(1) Anti-IL6R
mAb
Giant Cell Arteritis |
ZynquistaTM(**)
(10)
Oral SGLT-1&2 inh.
Worsening Heart Failure in Diabetes |
Fluzone® QIV
HD
Quadrivalent inactivated
Influenza vaccine - High dose |
|
SAR440340(**)
(1) Anti-IL33 mAb
Asthma |
venglustat
Oral GCS inhibitor
Fabry Disease |
sarilumab(**)
(1) Anti-IL6R
mAb
Polymyalgia Rheumatica |
ZynquistaTM(**)
(10) Oral SGLT-1&2
inhibitor
Type 2 Diabetes |
|
|
dupilumab(**)
(1) Anti-IL4Ralpha mAb
COPD |
venglustat
Oral GCS inhibitor
Gaucher Type 3 |
cemiplimab(**)
(1)
PD-1 inh mAb
1L NSCLC |
Cerdelga®
eliglustat
Gaucher T1, ERT switch Pediatric |
|
|
R
|
cemiplimab(**)
(1)
PD-1 inhibitor mAb
Advanced Basal Cell Carcinoma |
venglustat
Oral GCS inhibitor
Gaucher related Parkinson's Dis. |
cemiplimab(**)
(1)+ chemotherapy
PD-1 inh mAb + chemotherapy
1L NSCLC |
Praluent® (**)
(1)
alirocumab
LDL-C reduction - Pediatric |
|
|
|
isatuximab
Anti-CD38 mAb
1-2L AML / ALL pediatrics |
VerorabVax®
(VRVg) Purified vero rabies vaccine |
cemiplimab(**)
(1)
PD-1 inhibitor mAb
2L Cervical Cancer |
Men Quad TT Advanced generation meningococcal
ACYW conjugate vaccine |
|
|
|
SP0173 Tdap booster US |
isatuximab Anti-CD38 mAb
1L Newly Diag. MM Ti(8)
(IMROZ) |
Pediatric pentavalent
vaccine DTP-Polio-Hib
Japan |
|
|
|
|
|
Shan 6
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine |
|
-
Developed in collaboration with Regeneron
-
Regeneron product for which Sanofi has opt-in
rights
-
Also known as BIVV009
-
Developed with Denali
-
Receptor-interacting serine/threonine-protein
kinase 1
-
JIA: Juvenile Idiopathic Arthritis
-
Studies in collaboration with Roche
(atezolizumab)
-
Transplant ineligible
-
Transplant eligible
-
Developed in collaboration with Lexicon
(*) Phase of
projects determined by clinicaltrials.gov disclosure
timing
(**) Partnered and/or in collaboration - Sanofi
may have limited or shared rights on some of these
products
O :
Opt-in rights products for which rights have not
been exercised yet
R : Registrational
Study (other than Phase 3)
Expected
Submission Timeline(1)
NMEs |
isatuximab
anti-CD38 mAb
3L RRMM (ICARIA) |
fitusiran
RNAi anti-thrombin
Hemophilia A/B |
avalglucosidase alfa
NeoGAA
Pompe Disease |
venglustat
Oral GCS inhibitor
ADPKD(8) |
SAR341402
Rapid acting insulin
Type 1/2 Diabetes EU(3) |
sutimlimab(4)
Anti Comp C1s mAb
Cold Agglutinin Disease |
olipudase alfa
rhASM
ASD(6) |
efpeglenatide(**)(9)
LA GLP1-R agonist
Type 2 Diabetes |
|
2019(2) |
2020(2) |
2021(2) |
ADDITIONAL INDICATIONS |
Men Quad TT Adv. meningococcal
U.S.: 2y+ & EU: 12m+ |
sarilumab(**)(5)
Anti-IL6R mAb
Polyarticular JIA |
Aubagio® teriflunomide
Relapsing MS - Pediatric |
isatuximab
Anti-CD38 mAb
1L Newly Diag MM Ti (IMROZ) |
Fluzone® QIV HD
Quadrivalent inactivated
Influenza vaccine - HD |
Dupixent®(**)(5)
dupilumab
AD 6 - 11 years old |
ZynquistaTM(**)(7)
Oral SGLT-1&2 inhibitor
Type 2 Diabetes |
cemiplimab(**)(5)
PD-1 inhibitor mAb
2L Cervical Cancer |
|
isatuximab
Anti-CD38 mAb
1-3L RRMM (IKEMA) |
Shan 6
DTP-HepB-Polio-Hib
Ped hexavalent vaccine |
ZynquistaTM(**)(7)
Oral SGLT 1/2 inh
Worsening HF in Diab |
|
cemiplimab(**)(5)
PD-1 inhibitor mAb
Advanced BCC |
|
cemiplimab(**)(5)
PD-1 inhibitor mAb
1L NSCLC |
|
|
|
|
|
|
|
SAR156597
IL4/IL13 bispecific mAb
Systemic Scleroderma |
SP0232 (10)(**)
Respiratory Syncytial Virus mAbs |
|
|
|
SAR440340(**)(5)
Anti-IL33 mAb
Atopic Dermatitis |
HIV
Viral vector prime & rgp120 boost vaccine |
|
2022(2) |
2023(2) and
beyond |
|
Dupixent®(**)(5)
dupilumab
AD 6 m - 5 y old |
sarilumab(**)(5)
Anti-IL6R mAb
Giant Cell Arteritis |
SAR440340(**)(5)
Anti-IL33 mAb
COPD |
isatuximab
Anti-CD38 mAb
Newly Diag MM Te (GMMG) |
|
dupilumab(**)(5)
Anti-IL4Ralpha mAb
Asthma 6 - 11 y old |
sarilumab(**)(5)
Anti-IL6R mAb
Polym.Rheumatica |
SAR440340(**)(5)
Anti-IL33 mAb
Asthma |
venglustat
Oral GCS inhibitor
GrPD(11) |
|
venglustat
Oral GCS inhibitor
Gaucher Type 3 |
sarilumab(**)(5)
Anti-IL6R mAb
SJA |
dupilumab(**)(5)
+AR101 Anti-IL4Ralpha mAb +
Peanut Allergy - Ped |
venglustat
Oral GCS inhibitor
Fabry Disease |
|
SP0173
Tdap booster US |
Cerdelga®
Eliglustat, Gaucher T1, ERT switch, Ped |
Pediatric pentavalent
vaccine
DTP-Polio-Hib (Japan) |
VerorabVax®
(VRVg)
Purified vero rabies vaccine |
|
isatuximab
Anti-CD38 mAb
1-2L AML / ALL ped |
Praluent®(**)(5)
alirocumab
LDL-C reduction - Ped |
Men Quad TT Adv. Gen meningococcal
U.S.& EU 6w+ |
dupilumab(**)(5)
Anti-IL4Ra mAb
Eosinophilic Esophagitis |
|
|
|
Lemtrada® alemtuzumab
RRMS ped |
|
-
Excluding Phase 1
-
Projects within a specified year are not
arranged by submission timing
-
Submission strategy for the U.S. under
evaluation
-
Also known as BIVV009
-
Developed in collaboration with Regeneron
-
Acid Sphingomyelinase Deficiency
-
Developed in collaboration with Lexicon
-
Autosomal Dominant Polycystic Kidney
Disease
-
Developed in collaboration with Hanmi
-
Developed in collaboration with
AstraZeneca
-
Gaucher related Parkinson's Disease
(**) Partnered
and/or in collaboration - Sanofi may have limited or shared rights
on some of these products
Pipeline
Movements Since Q4 2018
|
Additions |
Removals |
Registration |
dupilumab(**)
(1) Anti-IL4Ralpha mAb
CRSwNP |
|
|
Fluzone® QIV
HD
Quadrivalent inactivated
Influenza vaccine - High dose |
Phase 3 |
|
|
|
Phase 2 |
isatuximab
Anti-CD38 mAb
1-2L AML / ALL pediatrics |
dupilumab(**)
(1) Anti-IL4Ralpha mAb
COPD |
|
|
SAR442168(**)
(2)
BTK inhibitor
Multiple Sclerosis |
|
|
|
Phase 1 |
SAR441169(**)
(3) RORC (ROR
gamma T) antagonist
Psoriasis |
|
|
|
|
|
|
|
-
Developed in collaboration with Regeneron
-
Developed in collaboration with Principia
-
Developed in collaboration with Lead
Pharma
(**) Partnered and/or in
collaboration - Sanofi may have limited or shared rights on some of
these products
Appendix 7: Expected R&D milestones
Products |
Expected milestones |
Timing |
Dupixent®(**)
(1) |
EU
regulatory decision in Asthma in Adult and Adolescent patients |
Q2
2019 |
ZynquistaTM(**)
(2) (sotagliflozin) |
EU
regulatory decision in Type 1 Diabetes |
Q2
2019 |
cemiplimab(**)
(1) |
EU
regulatory decision in Advanced Cutaneous Squamous Cell
Carcinoma |
Q2
2019 |
Praluent®(**)
(1) |
U.S.
regulatory decision in CV events reduction ODYSSEY OUTCOMES |
Q2
2019 |
Dupixent®(**)
(1) |
U.S.
regulatory decision in Chronic Rhinosinusitis with Nasal
Polyps |
Q2
2019 |
SAR440340(**)
(1) (Anti-IL33 mAb) |
Proof of concept study read-out in asthma |
Q2
2019 |
SAR439859 (SERD) |
Proof of concept study read-out in metastatic Breast Cancer |
Q3
2019 |
sutimlimab |
Proof of concept study read-out in refractory Immune
Thrombocytopenic Purpura |
Q4
2019 |
Fluzone® QIV HD |
U.S.
regulatory decision for >= 65-year old age group |
Q4
2019 |
sutimlimab |
Pivotal trial read-out in Cold Agglutinin Disease |
Q4
2019 |
Dupixent®(**)
(1) |
Pivotal trial read-out in Atopic Dermatitis in 6-11 years |
Q4 2019 |
ZynquistaTM(**)
(2) (sotagliflozin) |
Expected pivotal trial read-out in Type 2 Diabetes |
Q4 2019
- Q1 2020 |
Dupixent®(**)
(1) |
EU
regulatory decision in Atopic Dermatitis in Adolescent
patients |
Q1
2020 |
Dupixent®(**)
(1) |
EU
regulatory decision in Chronic Rhinosinusitis with Nasal
Polyps |
Q1
2020 |
isatuximab |
Pivotal trial read-out in 1-3L RRMM (IKEMA) |
Q1
2020 |
SAR440340(**)
(1) (Anti-IL33 mAb) |
Proof of concept study read-out in Chronic Obstructive Pulmonary
Disease |
Q1 2020 |
-
Developed in collaboration with Regeneron
-
Developed in collaboration with Lexicon
(**) Partnered and/or in
collaboration - Sanofi may have limited or shared rights on some of
these products
Appendix 8: Definitions of
non-GAAP financial indicators
Company
"Company" corresponds to Sanofi
and its subsidiaries
Company sales at constant
exchange rates (CER)
When we refer to changes in our
net sales "at constant exchange rates" (CER), this means that we
exclude the effect of changes in exchange rates.
We eliminate the effect of
exchange rates by recalculating net sales for the relevant period
at the exchange rates used for the previous period.
Reconciliation of net sales to
Company sales at constant exchange rates for the first quarter of
2019
€
million |
Q1 2019 |
Net sales |
8,391 |
Effect
of exchange rates |
(158) |
Company sales at constant exchange rates |
8,233 |
Business net income
Sanofi publishes a key non-GAAP
indicator.
Business net income is defined as net income attributable to equity
holders of Sanofi excluding:
- amortization of intangible
assets,
- impairment of intangible
assets,
- fair value remeasurement of
contingent consideration related to business combinations or to
disposals,
- other impacts associated with
acquisitions (including impacts of acquisitions on associates and
joint ventures),
- restructuring costs and similar
items(1),
- other gains and losses (including
gains and losses on disposals of non-current assets(1)),
- effects of IFRS 16 on lease
accounting,
- costs or provisions associated
with litigation(1),
- tax effects related to the items
listed above as well as effects of major tax disputes,
- net income attributable to
non-controlling interests related to the items listed above.
-
Reported in the line items
Restructuring costs and
similar items and Gains and losses on
disposals, and litigation, which are defined in Notes B.19 and
B.20. to our consolidated financial statements.
Q1 2019 Results
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Sanofi via Globenewswire
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