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 Sanofi
continues to expect 2019 business EPS(1) to grow between 3% and 5%
at CER(5) barring unforeseen major adverse events. Applying the
average April 2019 exchange rates, the currency impact on 2019
business EPS is estimated to be around 2%. 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.
Investor Relations: (+) 33 1 53 77 45 45 - E-mail:
IR@sanofi.com - Media Relations: (+) 33 1 53 77 46 46 -
E-mail: MR@sanofi.comWebsite: www.sanofi.com
Mobile app: SANOFI IR available on the App Store and
Google Play |
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 |
EmergingMarkets |
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:
- SAR441169, a RORC (ROR gamma T) antagonist entered phase
1 for the treatment of psoriasis.
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.
- An income of €60 million mainly reflecting a contingent price
adjustment on the disposal of the joint venture Sanofi Pasteur MSD
investment.
- 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 mAbMultiple
Sclerosis |
BIVV001(**)
(5) rFVIIIFc - vWF - XTEN(6) Hemophilia A |
SAR440340(**)
(12)Anti-IL33 mAbAtopic Dermatitis |
SAR422459(**) (14) ABCA4
gene therapy Stargardt Disease |
isatuximab Anti-CD38
mAb3L RRMM (ICARIA) |
cemiplimab(**) (12)PD-1
inhibitor mAbAdvanced 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 alfaNeo
GAA Pompe Disease |
ZynquistaTM(**) (20) Oral
SGLT-1&2 inhibitor Type 1 Diabetes (U.S./EU) |
SAR439459 anti-TGFb mAbAdvanced 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 |
venglustatOral GCS inhibitorADPKD(17) |
|
|
O |
REGN5458(**)
(2)Anti-BCMA-CD3 bispecific mAbRelapsing Refractory MM |
SAR443060(**) (8) RIPK1
inh(9)Amyotrophic Lateral Sclerosis |
SAR339375miRNA-21Alport Syndrome |
SP0232(**)
(16) Respiratory syncytial virusMonoclonal Antibody |
fitusiran
RNAi targeting anti-thrombin Hemophilia A and B |
|
|
O |
REGN4018(**) (2) Anti-MUC16-CD3 bispecific
mAbOvarian Cancer |
Next Gen
PCV(**) (10) Pneumococcal Conjugate
Vaccines |
|
|
sutimlimab(18)Anti Complement C1s mAb Cold Agglutinin
Disease |
|
|
SAR439859
SERDMetastatic Breast Cancer |
Herpes Simplex Virus Type
2 HSV-2 therapeutic vaccine |
|
|
SAR341402 Rapid acting
insulin Type 1/2 Diabetes |
|
SAR442720(**)
(3) SHP2 inhibitorSolid 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 mAbLeukemia |
SAR441169(**)
(11) RORC (ROR gamma T) antagonist, Psoriasis |
|
|
|
|
SAR441000(**) (4) Cytokine mRNASolid
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 mAbRelapsing Refractory MM |
dupilumab(**) (1)
Anti-IL4Ralpha mAb Asthma 6 - 11 years old |
isatuximabAnti-CD38
mAbNewly 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 mAb1-3L RRMM (IKEMA) |
Dupixent®(**)
(1)dupilumab AD 12 - 17 years old (EU) |
|
|
SAR439859
+ palbociclibSERD + CDK4/6 inhMetastatic Breast Cancer |
sarilumab(**) (1) Anti-IL6R mAb Systemic Juvenile
Arthritis |
isatuximab + cemiplimab(**)
(1) Anti-CD38 mAb + PD-1 inh mAbLymphoma |
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 mAbmCRC |
Dupixent®(**) (1)
dupilumab AD 6 months - 5 years old |
Lemtrada®
alemtuzumab RRMS - Pediatric |
Praluent®(**)
(1)alirocumabCV events reduction (U.S.) |
SAR443060(4) RIPK1 inh(5)Alzheimer's
Disease |
dupilumab(**) (1)
+ AR101 Anti-IL4Ralpha mAb + ImmunotherapyPeanut Allergy -
Pediatric |
isatuximab +
atezolizumab(7) Anti-CD38 mAb + PD-L1 inhibitor mAbSolid
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 |
venglustatOral GCS
inhibitorFabry Disease |
sarilumab(**) (1)
Anti-IL6R mAb Polymyalgia Rheumatica |
ZynquistaTM(**) (10) Oral
SGLT-1&2 inhibitor Type 2 Diabetes |
|
|
dupilumab(**)
(1) Anti-IL4Ralpha mAb COPD |
venglustatOral GCS
inhibitorGaucher Type 3 |
cemiplimab(**) (1)PD-1
inh mAb1L NSCLC |
Cerdelga®eliglustatGaucher T1, ERT switch
Pediatric |
|
|
R |
cemiplimab(**)
(1)PD-1 inhibitor mAbAdvanced Basal Cell Carcinoma |
venglustatOral GCS inhibitorGaucher related Parkinson's
Dis. |
cemiplimab(**)
(1)+ chemotherapyPD-1 inh mAb + chemotherapy1L NSCLC |
Praluent® (**) (1)alirocumabLDL-C reduction -
Pediatric |
|
|
|
isatuximabAnti-CD38 mAb 1-2L AML / ALL pediatrics |
VerorabVax® (VRVg)
Purified vero rabies vaccine |
cemiplimab(**) (1)PD-1
inhibitor mAb2L Cervical Cancer |
Men Quad TT Advanced
generation meningococcal ACYW conjugate vaccine |
|
|
|
SP0173 Tdap booster
US |
isatuximab Anti-CD38
mAb1L Newly Diag. MM Ti(8) (IMROZ) |
Pediatric pentavalent
vaccine DTP-Polio-Hib Japan |
|
|
|
|
|
Shan 6
DTP-HepB-Polio-HibPediatric 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
mAb3L RRMM (ICARIA) |
fitusiran RNAi
anti-thrombinHemophilia A/B |
avalglucosidase alfa
NeoGAA Pompe Disease |
venglustatOral GCS
inhibitorADPKD(8) |
SAR341402Rapid acting
insulinType 1/2 Diabetes EU(3) |
sutimlimab(4)Anti Comp
C1s mAb Cold Agglutinin Disease |
olipudase alfa
rhASMASD(6) |
efpeglenatide(**)(9)LA
GLP1-R agonistType 2 Diabetes |
|
2019(2) |
2020(2) |
2021(2) |
ADDITIONAL INDICATIONS |
Men Quad TT Adv.
meningococcal U.S.: 2y+ & EU: 12m+ |
sarilumab(**)(5)
Anti-IL6R mAbPolyarticular JIA |
Aubagio® teriflunomide
Relapsing MS - Pediatric |
isatuximabAnti-CD38 mAb1L
Newly Diag MM Ti (IMROZ) |
Fluzone® QIV
HD Quadrivalent inactivated Influenza vaccine - HD |
Dupixent®(**)(5)
dupilumabAD 6 - 11 years old |
ZynquistaTM(**)(7)Oral
SGLT-1&2 inhibitorType 2 Diabetes |
cemiplimab(**)(5) PD-1
inhibitor mAb2L Cervical Cancer |
|
isatuximabAnti-CD38
mAb1-3L RRMM (IKEMA) |
Shan 6
DTP-HepB-Polio-HibPed hexavalent vaccine |
ZynquistaTM(**)(7)Oral SGLT 1/2 inhWorsening HF in
Diab |
|
cemiplimab(**)(5) PD-1
inhibitor mAbAdvanced BCC |
|
cemiplimab(**)(5)PD-1
inhibitor mAb1L NSCLC |
|
|
|
|
|
|
|
SAR156597 IL4/IL13
bispecific mAb Systemic Scleroderma |
SP0232 (10)(**)
Respiratory Syncytial Virus mAbs |
|
|
|
SAR440340(**)(5)Anti-IL33
mAbAtopic 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 |
isatuximabAnti-CD38
mAbNewly 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
mAbAsthma |
venglustatOral GCS
inhibitorGrPD(11) |
|
venglustatOral GCS
inhibitorGaucher Type 3 |
sarilumab(**)(5)
Anti-IL6R mAb SJA |
dupilumab(**)(5) +AR101
Anti-IL4Ralpha mAb +Peanut Allergy - Ped |
venglustatOral GCS
inhibitorFabry 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 |
|
isatuximabAnti-CD38
mAb1-2L AML / ALL ped |
Praluent®(**)(5)alirocumabLDL-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 |
isatuximabAnti-CD38
mAb1-2L 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.
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