Paris, February 7, 2019
Sanofi delivers 2018 business EPS growth of
5.1% at CER
|
Q4 2018 |
Change |
Change at CER |
2018 |
Change |
Change at CER |
IFRS net sales reported |
€8,997m |
+3.5% |
+3.9% |
€34,463m |
-1.7% |
+2.5% |
IFRS net income reported |
€254m |
+101.6% |
- |
€4,306m |
-48.8%(2) |
- |
IFRS EPS reported |
€0.20 |
+100.0% |
- |
€3.45 |
-48.5%(2) |
- |
Business net income(1) |
€1,364m |
+2.9% |
+4.3% |
€6,819m |
-1.8% |
+4.2% |
Business EPS(1) |
€1.10 |
+3.8% |
+4.7% |
€5.47 |
-0.9% |
+5.1% |
Fourth-quarter sales(3) growth driven by Specialty Care and
Vaccines Net sales were €8,997 million, an increase of 3.5% on
a reported basis, 3.9%(3) at CER and 2.6% at CER/CS (4). Sanofi
Genzyme sales were up 37.4% (16.1% at CER/CS(4)), led by Immunology
and Rare Blood Disorder franchises. Vaccines sales increased 9.7%,
driven by successful influenza differentiation strategy and
Menactra®. CHC sales increased 1.9%, supported by Emerging Markets.
DCV(5) GBU sales were down 11.3%; Global Diabetes franchise sales
declined 10.5% in line with 2015-2018 guidance. Emerging Markets
sales(6) were up 6.0%, reflecting strong performance in Asia.
Full-Year 2018 sales growth from new products and Emerging
markets more than offset impact of U.S. LoEs Net sales in 2018
were €34,463 million, down 1.7% on a reported basis and grew 2.5%
at CER (up 0.6% at CER/CS(4)). Sanofi Genzyme grew 30.8% (+14.2% at
CER/CS(4)) to €7,226 million. Vaccines sales increased 2.4% to
€5,118 million while CHC sales were up 3.0% to €4,660 million.
DCV(5) GBU sales declined 13.8% to €4,511 million. Emerging Markets
sales were up 7.5%, supported by strong performance in China (up
12.7%). Sanofi delivers 2018 business EPS at the high end of its
guidance range Q4 2018 business EPS(1) up 4.7% at CER to €1.10.
Full-Year 2018 business EPS of €5.47 up 5.1% at CER and IFRS EPS of
€3.45 (down 48.5%(2)). Board proposes dividend of €3.07, the 25th
consecutive increase in dividend. Key achievements in sustaining
innovation in R&D Isatuximab met primary endpoint of ICARIA
phase 3 study in Relapsed/Refractory Multiple Myeloma. BIVV001
demonstrated sustained high factor levels at once-weekly dosing
with data presented at ASH. FDA Priority Review granted for
Dupixent® in adolescents with moderate-to-severe atopic dermatitis.
R&D strategy evolves towards prioritization of Specialty Care
and Vaccines, leveraging technology platforms and data science.
2019 financial outlook Sanofi expects 2019 business EPS(1)
to grow between 3% and 5%(7) at CER, barring unforeseen major
adverse events. Applying average January 2019 exchange rates, the
positive currency impact on 2019 business EPS is estimated to be
between 1% to 2%. |
Sanofi Chief
Executive Officer, Olivier Brandicourt, commented:"In the
fourth quarter, we continued the momentum of the previous quarter
and we delivered 5% full-year business EPS growth, at the high end
of our guidance. In 2018, we executed on important launches
including Dupixent®, Libtayo® and Cablivi®, as the headwinds from
our U.S. LoEs began to moderate. Additionally, the acquisitions of
Bioverativ and Ablynx provided the foundation to build a leading
Rare Blood Disorder franchise and to enhance our biologic discovery
capabilities. As we enter 2019, our focus remains on delivering our
business priorities and transforming Sanofi to address the evolving
business dynamics facing our industry." |
(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 10 for definitions). The consolidated income statement for
Q4 2018 is provided in Appendix 3 and a reconciliation of reported
IFRS net income to business net income is set forth in Appendix 4;
(2) Excluding Animal Health gain on disposal, full-year IFRS net
income was up 14.5% and full-year IFRS EPS was up 15.3%; (3)
Changes in net sales are expressed at constant exchange rates (CER)
unless otherwise indicated (see Appendix 10); (4) Constant
Structure: Adjusted for Bioverativ acquisition and divestment of
European Generics business; (5) DCV: Diabetes and Cardiovascular;
(6) See definition page 8; (7) 2018 business EPS was €5.47.
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 |
2018 fourth-quarter and full-year Sanofi
sales
Unless otherwise
indicated, all percentage changes in sales in this press release
are stated at CER(8). |
In the fourth quarter of 2018, Company sales
were €8,997 million, up 3.5% on a reported basis. Exchange rate
movements had a negative effect of 0.4 percentage points mainly
driven by the movement of the Turkish Lira, Brazilian Real and
Argentine Peso. At CER, Company sales increased 3.9%.
Full-year Company sales reached €34,463 million,
down 1.7% on a reported basis. Exchange rate movements had an
unfavorable effect of 4.2 percentage points. At CER, Company sales
were up 2.5%.
Global Business Units
The table below presents sales by Global
Business Unit (GBU). Please note that Emerging Markets sales for
Specialty Care and Diabetes and Cardiovascular are included in the
General Medicines and Emerging Markets GBU.
Net Sales by GBU
(€ million) |
Q4 2018 |
Change at CER |
2018 |
Change at CER |
Sanofi Genzyme
(Specialty Care)(a) |
|
2,054 |
|
+37.4%(c) |
7,226 |
+30.8%(d) |
Diabetes and
Cardiovascular(a) |
|
1,170 |
|
-11.3% |
4,511 |
-13.8% |
General Medicines &
Emerging Markets(b) |
|
3,052 |
|
-6.6%(e) |
12,948 |
-2.8%(f) |
Total
Pharmaceuticals |
|
6,276 |
|
+3.0% |
24,685 |
+2.4% |
Consumer Healthcare
(CHC) |
|
1,194 |
|
+1.9% |
4,660 |
+3.0% |
Sanofi Pasteur
(Vaccines) |
|
1,527 |
|
+9.7% |
5,118 |
+2.4% |
Total net
sales |
|
8,997 |
|
+3.9% |
34,463 |
+2.5% |
(a) Does not include Emerging Markets sales - see definition
page 8; (b) Includes Emerging Markets sales for Diabetes &
Cardiovascular and Specialty Care; (c)+16.1% at CS; (d)+14.2% at
CS; (e) -1.8% at CS; (f)-1.6% at CS
Global Franchises
The tables below present fourth-quarter and 2018
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) |
Q4 2018 |
Change at CER |
Developed Markets |
Change at CER |
EmergingMarkets |
Change at CER |
Specialty Care |
2,328 |
+35.2% |
2,054 |
+37.4% |
274 |
+22.4% |
Diabetes and
Cardiovascular |
1,552 |
-7.1% |
1,170 |
-11.3% |
382 |
+7.9% |
Established Rx
Products |
2,126 |
-6.8% |
1,242 |
-13.0% |
884 |
+2.9% |
Consumer Healthcare
(CHC) |
1,194 |
+1.9% |
789 |
-0.4% |
405 |
+6.4% |
Generics |
270 |
-33.8%* |
97 |
-61.4%** |
173 |
+3.8% |
Vaccines |
1,527 |
+9.7% |
1,054 |
+13.3% |
473 |
+2.5% |
Total net
sales |
8,997 |
+3.9% |
6,406 |
+3.0% |
2,591 |
+6.0% |
* +6.7% at CS**+12.9% at CS
Net
sales by Franchise (€ million) |
2018 |
Change at CER |
Developed Markets |
Change at CER |
EmergingMarkets |
Change at CER |
Specialty Care |
8,269 |
+29.0% |
7,226 |
+30.8% |
1,043 |
+18.7% |
Diabetes and
Cardiovascular |
6,083 |
-7.9% |
4,511 |
-13.8% |
1,572 |
+13.1% |
Established Rx
Products |
8,843 |
-6.1% |
5,090 |
-14.1% |
3,753 |
+6.6% |
Consumer Healthcare
(CHC) |
4,660 |
+3.0% |
3,072 |
-0.1% |
1,588 |
+8.9% |
Generics |
1,490 |
-9.8%* |
805 |
-19.4%** |
685 |
+3.0% |
Vaccines |
5,118 |
+2.4% |
3,647 |
+4.5% |
1,471 |
-2.3% |
Total net
sales |
34,463 |
+2.5% |
24,351 |
+0.5% |
10,112 |
+7.5% |
* -0.6% at CS**-3.8% at CS (8) See Appendix 10 for
definitions of financial indicators.
Pharmaceuticals
Fourth-quarter Pharmaceutical sales were up 3.0%
to €6,276 million mainly driven by the Immunology and Rare Blood
Disorder franchises which were partially offset by Diabetes,
Established Rx Products and the disposal of the European generics
business. Full-year sales for Pharmaceuticals increased 2.4% to
€24,685 million.
Rare Disease franchise
Net sales (€ million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
Myozyme® /
Lumizyme® |
226 |
+10.7% |
840 |
+10.8% |
Fabrazyme® |
206 |
+14.4% |
755 |
+9.8% |
Cerezyme® |
190 |
+9.3% |
711 |
+6.4% |
Aldurazyme® |
54 |
+16.7% |
206 |
+6.7% |
Cerdelga® |
44 |
+33.3% |
159 |
+31.0% |
Others Rare
Disease |
74 |
-6.5% |
287 |
-5.4% |
Total Rare
Disease |
794 |
+10.9% |
2,958 |
+8.3% |
In the fourth quarter, Rare Disease
delivered a solid performance with sales up 10.9% to €794 million,
driven by Gaucher, Pompe and Fabry therapies. In the U.S. and
Europe, fourth-quarter Rare Disease sales grew 8.5% (to €292
million) and 3.1% (to €262 million), respectively, while Emerging
Markets sales were up 32.6% to €150 million. Full-year Rare Disease
sales increased 8.3% to €2,958 million.
Fourth-quarter Gaucher (Cerezyme®
and Cerdelga®) sales were up 13.0% to €234 million,
supported by the increasing penetration of Cerdelga® in Europe and
the sustained growth of Cerezyme® in Emerging Markets.
Fourth-quarter Cerdelga® sales increased 33.3% to €44 million.
Full-year Gaucher sales were €870 million, up 10.0%.
Fourth-quarter Pompe
(Myozyme®/Lumizyme®) sales grew 10.7% to €226
million, supported by positive trends in naïve patient accruals.
Fourth-quarter Myozyme®/Lumizyme® sales increased 18.8% to €79
million in the U.S. and 1.1% to €96 million in Europe,
respectively. Full-year Myozyme®/Lumizyme® sales increased 10.8% to
€840 million.
Fourth-quarter Fabry (Fabrazyme®)
sales grew 14.4% to €206 million. Fourth-quarter sales in the U.S.
and Europe increased 9.9% (to €104 million) and 4.8% (to €45
million), respectively. Full-year Fabrazyme® sales were up 9.8% to
€755 million.
Multiple Sclerosis franchise
Net sales (€
million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
Aubagio® |
446 |
+12.6% |
1,647 |
+9.3% |
Lemtrada® |
96 |
-14.3% |
402 |
-11.6% |
Total Multiple
Sclerosis |
542 |
+6.6% |
2,049 |
+4.4% |
Fourth-quarter Multiple Sclerosis (MS) sales were up 6.6%
to €542 million, as double-digit Aubagio® sales growth was
partially offset by the decline in Lemtrada® sales. Full-year MS
sales increased 4.4% to €2,049 million.
Fourth-quarter Aubagio® sales increased
12.6% to €446 million, driven by the U.S. (up 13.5% to €311
million) and Europe (up 12.5% to €108 million). Full-year Aubagio®
sales increased 9.3% to €1,647 million.
In the fourth quarter, Lemtrada® sales
decreased 14.3% to €96 million due to lower U.S. sales (down 19.6%
to €45 million) and European sales (down 11.9% to €37 million),
reflecting increased competition. Full-year Lemtrada® sales
decreased 11.6% to €402 million.
Immunology franchise
Net sales (€
million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
Dupixent® |
280 |
+130.5% |
788 |
+268.0% |
Kevzara® |
31 |
+275.0% |
83 |
+663.6% |
Total
Immunology |
311 |
+139.7% |
871 |
+287.0% |
Dupixent® (collaboration with Regeneron)
for the treatment of moderate-to-severe atopic dermatitis in adults
and moderate-to-severe adolescent and adult asthma generated sales
of €280 million in the fourth quarter compared to €118 million in
the fourth quarter of 2017. In the U.S., Dupixent® sales reached
€225 million in the fourth quarter (up 87.9%). Demand for the
product remains strong and total prescriptions (source: IQVIA
weekly TRx data) increased 25% sequentially in the fourth quarter,
bolstered by the branded DTC campaign and the recent U.S. launch in
asthma. Fourth-quarter sales in Europe were €29 million. Full-year
Dupixent® sales were €788 million compared to €219 million in the
same period of 2017. By the end of 2018, Dupixent® had been
launched in 17 countries.
Kevzara® (collaboration with Regeneron)
for rheumatoid arthritis generated sales of €31 million in the
fourth quarter, of which €23 million was in the U.S. reflecting
improved commercial coverage. Kevzara® was launched in 14 countries
in Europe in 2018 (included France in the fourth quarter).
Full-year Kevzara® sales were €83 million.
Rare Blood Disorder franchise
Net sales (€
million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
Eloctate® |
196 |
- |
608 |
- |
Alprolix® |
95 |
- |
285 |
- |
Cablivi® |
3 |
- |
4 |
- |
Total Rare Blood
Disorder |
294 |
- |
897 |
- |
Bioverativ was consolidated in Sanofi's
Financial Statements from March 9, 2018. Fourth-quarter sales of
the Rare Blood Disorder franchise were €294 million (up 5.7%
on a pro forma basis(9)), including non-U.S. sales of €58 million
with Japan as the primary contributor. Full-year consolidated sales
of the Rare Blood Disorder franchise were €897 million, up 12.5% on
a pro forma basis(9).
Eloctate®, a recombinant
antihemophilic Factor VIII, indicated for the treatment of
hemophilia A, generated sales of €196 million in the fourth
quarter, up 4.3% on a pro forma basis(10). The performance in the
U.S., Japan and Australia was partially offset by a decline in
sales in Canada following the previously announced tender loss. The
competitive dynamics in the U.S. resulted in a deceleration in
growth compared with the previous quarter. Full-year consolidated
Eloctate® sales were €608 million, up 15.0% on a pro forma
basis(10).
Alprolix®, a recombinant coagulation
Factor IX, indicated for the treatment of hemophilia B, generated
sales of €95 million in the fourth quarter, up 5.3% on a pro forma
basis(10). Full-year consolidated Alprolix® sales were €285
million, up 6.6% on a pro forma basis(10).
Cablivi® (caplacizumab) for the treatment
of adults with acquired thrombotic thrombocytopenic purpura (aTTP),
received EU approval in September and was launched in its first
market, Germany, in October. Sales in the fourth quarter were €3
million.
Oncology franchise
Net sales (€
million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
Jevtana® |
114 |
+14.1% |
422 |
+13.0% |
Thymoglobulin® |
78 |
+9.9% |
297 |
+7.2% |
Mozobil® |
47 |
+15.0% |
171 |
+8.6% |
Eloxatin® |
43 |
0.0% |
182 |
+5.0% |
Taxotere® |
38 |
-2.5% |
166 |
-0.6% |
Zaltrap® |
23 |
+14.3% |
91 |
+27.0% |
Others |
44 |
0.0% |
165 |
-32.1% |
Total
Oncology |
387 |
+8.1% |
1,494 |
+2.1% |
(9) Growth comparing fourth-quarter 2018
sales versus fourth-quarter 2017 sales, and full 2018 sales versus
full 2017 sales at CER. Excluding the Sobi contract manufacturing
sales and including Cablivi® sales in 2018. Unaudited data. (10)
Growth comparing fourth-quarter 2018 sales versus fourth-quarter
2017 sales, and full 2018 sales versus full 2017 sales at CER.
Excluding the Sobi contract manufacturing sales. Unaudited
data.
Fourth-quarter Oncology sales increased
8.1% to €387 million. Consistent with the Company's portfolio
prioritization efforts, Sanofi sold Leukine® on January 31, 2018.
Excluding Leukine®, Oncology fourth-quarter sales were up 10.2%.
Full-year Oncology sales were up 2.1% to €1,494 million and up 6.3%
excluding Leukine®.
Jevtana® sales were up 14.1% to €114
million in the fourth quarter supported by the performance in the
U.S. (up 20.0% to €50 million). Full-year Jevtana® sales increased
13.0% to €422 million. In the fourth quarter and full year,
Thymoglobulin® sales increased 9.9% (to €78 million) and
7.2% (to €297 million), respectively.
In September, Libtayo® (cemiplimab-rwlc,
collaboration with Regeneron) was approved in the U.S. 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. Libtayo® is the only
treatment for advanced CSCC approved by the FDA. U.S. Libtayo®
sales were $15 million and were consolidated by Regeneron.
Diabetes franchise
Net sales (€
million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
Lantus® |
866 |
-19.7% |
3,565 |
-19.0% |
Toujeo® |
211 |
-2.3% |
840 |
+7.2% |
Total
glargine |
1,077 |
-16.8% |
4,405 |
-15.1% |
Apidra® |
89 |
-6.2% |
357 |
+0.3% |
Amaryl® |
77 |
-1.3% |
335 |
+4.8% |
Insuman® |
23 |
-14.8% |
91 |
-12.0% |
Admelog® |
57 |
- |
93 |
- |
Soliqua® |
27 |
+188.9% |
73 |
+188.5% |
Total
Diabetes |
1,375 |
-10.5% |
5,472 |
-10.4% |
In the fourth quarter, global Diabetes
sales decreased 10.5% to €1,375 million, due to lower glargine
(Lantus® and Toujeo®) sales in the U.S. Fourth-quarter U.S.
Diabetes sales were down 26.3% to €555 million, reflecting the
previously announced changes in coverage of the Part D business and
a continued decline in average U.S. glargine net prices.
Fourth-quarter sales in Emerging Markets increased 7.7% to €376
million. Fourth-quarter sales in Europe decreased 0.6% to €320
million, supported by Toujeo® growth. Full-year global Diabetes
sales decreased 10.4% to €5,472 million. This in turn resulted in a
CAGR sales decline for the global Diabetes franchise over 2015-2018
of 7.4% at CER, in line with the guidance.
Fourth-quarter glargine (Lantus® and
Toujeo®) sales decreased 16.8% to €1,077 million. U.S. glargine
sales were down 35.7% to €460 million, reflecting the
aforementioned changes in coverage in Part D and a continued
decline in average U.S. glargine net prices. In Europe, glargine
sales were stable ato €245 million reflecting strong Toujeo®
performance. Full-year glargine sales decreased 15.1% to €4,405
million. In 2019, Sanofi expects a further net pricing decline for
its glargine products in the U.S. as a result of higher rebates
needed to maintain broad payer coverage and the increased Part D
coverage gap impact.
In the fourth quarter, Lantus® sales were
€866 million, down 19.7%. In the U.S., Lantus® sales decreased
37.0% to €379 million, mainly reflecting lower average net price
and changes in coverage in Part D. In Europe, fourth-quarter
Lantus® sales were €168 million, down 8.2% due to biosimilar
glargine competition and patients switching to Toujeo®. In Emerging
Markets, fourth-quarter Lantus® sales were up 7.7% to €242 million.
Full-year Lantus® sales decreased 19.0% to €3,565 million.
Fourth-quarter Toujeo® sales were €211
million, down 2.3%. In the U.S., fourth-quarter Toujeo® sales were
€81 million, down 29.1%. In Europe and Emerging Markets,
fourth-quarter Toujeo® sales were €77 million (up 23.8%) and €31
million (up 32.0%), respectively. Full-year Toujeo® sales increased
7.2% to €840 million.
Fourth-quarter Apidra® sales decreased
6.2% to €89 million. Lower sales in the U.S. (down 36.0% to €17
million) offset growth in Emerging Markets (up 10.7% to €29
million). Full-year Apidra® sales increased 0.3% to €357
million.
Amaryl® sales were €77 million, down 1.3%
in the fourth quarter, of which €66 million were generated in
Emerging Markets (up 1.5%). Full-year Amaryl® sales were up 4.8% at
€335 million.
Admelog® (insulin lispro injection) 100
Units/mL, which was launched in the U.S. in April, generated sales
of €57 million in the fourth quarter mainly due to access in
Managed Medicaid. Full-year Admelog® sales were €93 million.
Fourth-quarter and full-year Soliqua®
100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL
injection) and Suliqua(TM) sales were €27 million and €73
million, respectively.
Cardiovascular franchise
Net sales (€
million) |
Q4 2018 |
Change at CER |
2018 |
Change at CER |
Praluent® |
82 |
+50.9% |
261 |
+56.1% |
Multaq® |
95 |
+20.8% |
350 |
+7.1% |
Total cardiovascular
franchise |
177 |
+33.1% |
611 |
+23.5% |
Fourth-quarter Praluent® (collaboration
with Regeneron) sales increased 50.9% to €82 million. U.S. sales of
€52 million (up 45.7%) benefited from ESI coverage exclusivity
which began in the third quarter. In Europe, sales were €23 million
(up 53.3%). Full-year Praluent® sales increased 56.1% to €261
million. In 2019, Sanofi expects higher U.S. rebates to impact
Praluent® sales.
Fourth-quarter and full-year Multaq®
sales were up 20.8% (to €95 million) and 7.1% (to €350 million),
respectively.
Established Rx Products
Net sales (€
million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
Lovenox® |
346 |
-9.0% |
1,465 |
-3.0% |
Plavix® |
328 |
-4.9% |
1,440 |
+1.2% |
Aprovel®/Avapro® |
151 |
-2.5% |
652 |
-1.7% |
Renvela®/Renagel® |
96 |
-39.4% |
411 |
-46.7% |
Synvisc®
/Synvisc-One® |
81 |
-7.0% |
313 |
-15.0% |
Myslee®/Ambien®/Stilnox® |
59 |
-1.7% |
231 |
-6.9% |
Allegra® |
26 |
-21.9% |
124 |
-17.7% |
Other |
1,039 |
-2.5% |
4,207 |
-1.8% |
Total Established Rx
Products |
2,126 |
-6.8% |
8,843 |
-6.1% |
In the fourth quarter, Established Rx
Products sales decreased 6.8% to €2,126 million, reflecting
lower U.S. sales of Renvela®/Renagel® (sevelamer) due to generic
competition, together with lower sales of Lovenox® in Europe and
Plavix® in Japan. Full-year Established Rx Products sales decreased
6.1% to €8,843 million.
Fourth quarter Lovenox® sales decreased
9.0% to €346 million, reflecting biosimilar competition in the UK,
Poland, Germany, Italy and France. Sales in Europe were down 13.9%
to €199 million impacted mainly by price erosion in France and
Germany triggered by biosimilar launches. In Emerging Markets,
Lovenox® sales grew 3.3% to €117 million. Full-year Lovenox® sales
were down 3.0% to €1,465 million
In the fourth quarter, Plavix® sales were
down 4.9% to €328 million. The decline was mainly driven by generic
penetration in Japan (sales down 31.5% to €38 million) and
procurement timing in the Middle East. Plavix® sales continued to
grow in China. Sales of the product decreased in the rest of
Emerging Markets and increased 2.9% in Europe. Full-year Plavix®
sales were up 1.2% to €1,440 million.
Fourth-quarter Aprovel®/Avapro® sales
decreased 2.5% to €151 million due to loss of exclusivity in Japan
in December 2017. In Emerging Markets, performance continued to be
strong with sales up 8.6% to €112 million. Full-year
Aprovel®/Avapro® sales decreased 1.7% to €652 million.
Fourth-quarter Renvela®/Renagel®
(sevelamer) sales decreased 39.4% to €96 million due to generic
competition in the U.S. (down 53.0% to €57 million). Full-year
Renvela®/Renagel® sales decreased 46.7% to €411 million.
Generics
In the fourth quarter, Generics sales
decreased 33.8% to €270 million, reflecting the divestment of the
European generics business Zentiva at the end of the third quarter.
This divestiture was consistent with Sanofi's strategy to simplify
and reshape the company. At CS, fourth quarter Generic sales
increased 6.7%. Emerging Markets Generics sales increased 3.8% to
€173 million. Full-year Generics sales decreased 9.8% to €1,490
million and decreased 0.6% at CS.
Consumer Healthcare
CHC sales by geography and category are provided
in Appendix 1.
Net sales (€
million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
Allergy Cough & Cold |
268 |
-6.3% |
1,124 |
-1.7% |
of which
Allegra® |
80 |
-3.6% |
396 |
+1.2% |
of which
Mucosolvan® |
30 |
-14.3% |
110 |
+1.8% |
of which Xyzal® |
10 |
+42.9% |
41 |
-32.3% |
Pain |
336 |
+4.6% |
1,254 |
+6.7% |
of which
Doliprane® |
98 |
+3.2% |
333 |
+4.0% |
of which
Buscopan® |
49 |
0.0% |
194 |
+16.0% |
Digestive |
256 |
+4.4% |
986 |
+8.7% |
of which
Dulcolax® |
55 |
0.0% |
216 |
+7.1% |
of which
Enterogermina® |
47 |
+14.3% |
183 |
+16.1% |
of which
Essentiale® |
48 |
+4.1% |
177 |
+8.7% |
of which
Zantac® |
34 |
+13.8% |
127 |
+13.7% |
Nutritionals |
174 |
+9.1% |
675 |
+4.7% |
Other |
160 |
0.0% |
621 |
-5.2% |
of which Gold
Bond® |
67 |
+16.1% |
211 |
+9.5% |
Total Consumer
Healthcare |
1,194 |
+1.9% |
4,660 |
+3.0% |
In the fourth quarter, Consumer
Healthcare (CHC) sales increased 1.9% to €1,194 million, driven
by Emerging Markets and the U.S. Full-year CHC sales increased 3.0%
to €4,660 million.
In Europe, fourth-quarter CHC sales were
down 3.6% to €368 million. Lower sales in the Allergy Cough &
Cold category (down 13.3%) resulted from a weak season coupled with
a strong base for comparison in the fourth quarter of 2017, which
featured an unusual spike in demand. Full-year CHC sales in Europe
decreased 0.2% to €1,403 million.
In the U.S., fourth-quarter CHC sales
increased 6.0% to €274 million, supported by the Digestive category
(up 10.9%) and Gold Bond performance. Full-year U.S. CHC sales
decreased 1.1% to €1,066 million.
In Emerging Markets, fourth-quarter CHC
sales increased 6.4% to €405 million, mainly driven by a solid
demand in Brazil (mainly Pain category). Full-year Emerging Markets
CHC sales increased 8.9% to €1,588 million.
Vaccines
Net sales (€
million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
Influenza
vaccines(incl. Vaxigrip®, Fluzone HD®, Fluzone®, Flublok®) |
596 |
+17.1% |
1,708 |
+7.2% |
Polio/Pertussis/Hib
vaccines (incl. Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and
Imovax®) |
504 |
+3.0% |
1,749 |
-0.7% |
Meningitis/Pneumo
vaccines (incl. Menactra®) |
131 |
+59.3% |
609 |
+0.6% |
Adult Booster vaccines
(incl. Adacel ®) |
135 |
-2.9% |
470 |
+1.3% |
Travel and other
endemic vaccines |
130 |
-18.8% |
488 |
+1.8% |
Other vaccines |
31 |
+158.3% |
94 |
+3.2% |
Total
Vaccines |
1,527 |
+9.7% |
5,118 |
+2.4% |
Fourth-quarter Vaccines sales were up
9.7% driven by the performance in the U.S. (up 10.4%) and Europe
(up 21.9%). In Emerging Markets, fourth-quarter Vaccines sales
increased 2.5%. Fourth-quarter performance was consistent with
Sanofi's expectation that sales of the Vaccines GBU would grow mid
to high-single digits in the second half of 2018. Full-year
Vaccines sales increased 2.4% to €5,118 million.
Fourth-quarter Influenza vaccines sales
were up 17.1% to €596 million, reflecting slightly greater
weighting of shipments in the fourth quarter versus the prior year
as well as Sanofi Pasteur's influenza differentiation strategy
which included the successful launch of Flubok® in the U.S. and the
strong performance of Vaxigrip® QIV in Europe. Full-year Influenza
vaccines sales increased 7.2% to €1,708 million.
In the fourth quarter,
Polio/Pertussis/Hib (PPH) vaccines sales were up 3.0% to
€504 million, driven by higher Hexaxim sales in Emerging Markets.
In China, Pentaxim® supply returned to normal. In the U.S., PPH
vaccines sales decreased 9.2% to €102 million reflecting lower
sales of Polio and Hib vaccines. Full-year Polio/Pertussis/Hib
vaccines sales were down 0.7% to €1,749 million.
Fourth-quarter Menactra® sales increased
63.3% to €130 million, driven by sales in the U.S. and Middle-East.
In the U.S., fourth-quarter Menactra® sales were €80 million
(up 45.3%) reflecting timing differences in CDC and wholesaler
buying patterns. Full-year Menactra® sales were up 4.5% to €608
million.
Fourth-quarter and full-year Adult
Booster vaccines sales decreased 2.9% (to €135 million) and
increased 1.3% (to €470 million), respectively.
Fourth-quarter Travel and other endemic
vaccines sales were €130 million, down 18.8% reflecting lower
Rabies and Typhoid vaccines sales. Full-year Travel and other
endemic vaccines sales were up 1.8% to €488 million.
Company sales by geographic
region
Sanofi sales (€
million) |
Q4
2018 |
Change at CER |
2018 |
Change at CER |
United
States |
3,195 |
+8.7% |
11,540 |
+0.7% |
Emerging
Markets(a) |
2,591 |
+6.0% |
10,112 |
+7.5% |
of which
Asia |
941 |
+8.4% |
3,962 |
+9.3% |
of which Latin
America |
710 |
+2.6% |
2,612 |
+8.1% |
of which Africa,
Middle East |
601 |
+5.2% |
2,232 |
+1.1% |
of which
Eurasia(b) |
288 |
+3.3% |
1,152 |
+10.1% |
Europe(c) |
2,342 |
-4.8% |
9,434 |
-0.6% |
Rest of the
World(d) |
869 |
+6.7% |
3,377 |
+2.7% |
of which
Japan |
423 |
-1.4% |
1,710 |
-2.0% |
Total Sanofi
sales |
8,997 |
+3.9% |
34,463 |
+2.5% |
- 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
Fourth-quarter sales in the U.S. were up
8.7% to €3,195 million. This mainly reflected the strong
performances of Dupixent® and Aubagio®, together with the
consolidation of Eloctate® and Alprolix® sales, which were partly
offset by lower sales of the Diabetes franchise (down 26.3%) and of
sevelamer. In the U.S., full-year sales increased 0.7% to €11,540
million.
Fourth-quarter sales in Emerging Markets
increased 6.0% to €2,591 million, mainly driven by Rare Diseases
(up 32.6%), Diabetes (up 7.7%) and CHC (up 6.4%). In Asia, sales
were up 8.4% to €941 million in the fourth quarter, sustained by
the performance in China (up 8.3% to €566 million). In Latin
America, fourth-quarter sales increased 2.6% to €710 million.
Fourth-quarter sales in Brazil were up 10.0% to €254 million. In
Africa and the Middle East region, fourth-quarter sales were €601
million, up 5.2%. Fourth-quarter sales in the Eurasia region
increased 3.3% to €288 million, driven by the growth in Turkey
which was partially offset by lower sales in Russia (€153 million,
down 4.0%). Full-year sales in Emerging Markets increased 7.5% to
€10,112 million. In 2018, sales in China, Brazil and Russia were
€2,464 million (up 12.7%), €1,023 million (up 7.0%) and €605
million (up 4.6%), respectively.
Fourth-quarter sales in Europe were
€2,342 million, down 4.8% due to the divestment of the European
Generics business. At CS, fourth-quarter sales were up 2.0% driven
by Vaccines (up 21.9%) and the roll-out of Dupixent® which offset
lower sales in Established Rx Products (down 6.8%). In Europe,
full-year sales decreased 0.6% to €9,434 million and increased 1.1%
at CS.
Sales in Japan decreased 1.4% to €423
million in the fourth quarter. The consolidation of Rare Blood
Disorder sales was more than offset by the impact of Plavix®
and Aprovel® generic competition and lower Vaccines sales. In
Japan, full-year sales decreased 2.0% to €1,710 million.
R&D update
Consult Appendix 6 for
full overview of Sanofi's R&D pipeline |
R&D strategy
Sanofi is today providing an update on the
evolution of its R&D strategy. Consistent with its ambition to
be an industry innovation leader, Sanofi has increased its R&D
focus on Specialty Care therapy areas (Oncology, Immunology, Rare
Disease and Rare Blood Disorder) while maintaining its commitment
to Vaccines. Since 2017, the number of R&D programs in these
areas has increased significantly, and they now represent over 90%
of Sanofi's clinical portfolio. This change reflects advances in
the Company's R&D capabilities and understanding of human
biology.
In support of this strategy, Sanofi recently
carried out a rigorous pipeline prioritization review to accelerate
investment behind its most promising programs and to discontinue
those with a less attractive expected return profile. As a result,
the Company is accelerating the development of 17 programs,
including 8 in Oncology. Thirteen development projects and 25
research projects are being discontinued to enhance the company's
focus on delivering first and best in class medicines. Overall,
Sanofi could potentially submit 9 new medicines and 25 additional
indications to regulatory authorities over 2019 to 2022.
Through the development of its own expertise and
the establishment of partnerships with industry pioneers, Sanofi
has access to a broad range of therapeutic modalities that enable a
more customized, science-driven approach to targeting disease. This
includes development of next-generation biologics, such as
multi-specific antibodies and Nanobodies, which provide new
opportunities relative to traditional monoclonal antibodies in
areas such as oncology and immunology, as well as gene therapies.
The Company is also employing data science and machine learning
across the R&D organization to generate higher quality data,
accelerate development and regulatory submissions, and reduce
costs. Sanofi expects to maintain an annual R&D budget of
approximately €6 billion through 2021.
Regulatory update
Regulatory updates since October 31, 2018
include the following:
- In February, the European Medicine Agency's Committee for
Medicinal Products for Human Use (CHMP) has recommended approval of
Praluent® (collaboration with Regeneron) in European Union
to reduce cardiovascular risk in people with established
atherosclerotic cardiovascular disease.
- In December, the FDA approved the hexavalent vaccine,
Vaxelis(TM), for use in children from 6 weeks through 4
years of age. Vaxelis(TM) was developed as part of a joint
partnership between Sanofi and Merck in the U.S. and Canada.
Commercial supply will not be available in the U.S. prior to
2020.
- In December, Dupixent® ( collaboration with Regeneron)
was submitted to the FDA for the treatment of adults with
inadequately-controlled chronic rhinosinusitis with nasal polyps
(CRSwNP).
- In December, the European Commission granted marketing
authorization for Dengvaxia® to prevent dengue disease in
individuals 9-45 years of age with a documented prior dengue
infection and who are living in endemic areas.
- In November, the CHMP recommended approval in European Union of
fexinidazole the first all-oral treatment for sleeping
sickness.
- In November, the FDA accepted for Priority Review the
supplemental Biologics License Application (sBLA) for
Dupixent® in adolescent patients 12 to 17 years of age with
moderate-to-severe atopic dermatitis, whose disease is inadequately
controlled with topical therapies or for whom topical treatment is
medically inadvisable. The target action data for the FDA decision
is March 11, 2019.
At the beginning of February 2019, the R&D
pipeline contained 81 projects including 33 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, Sanofi announced that Isatuximab phase 3
trial (ICARIA study) met primary endpoint of prolonging progression
free survival in patients with relapsed/refractory multiple
myeloma
- In January, the New England Journal of Medicine (NEJM)
published positive results of the Phase 3 trial of Cablivi®
(caplacizumab) in adults with acquired thrombotic thrombocytopenic
purpura (aTTP).
- In November, new analyses on mortality from the ODYSSEY
OUTCOMES trial evaluating Praluent® were presented at the
American Heart Association (AHA) Scientific Sessions. In November,
the New England Journal of Medicine (NEJM) also published detailed
results of this trial.
- Shan 6, a pediatric hexavalent vaccine, entered phase
3.
Phase 2:
- A phase 2 study evaluating the combination of isatuximab
(anti-CD38 mAb) and cemiplimab (collaboration with
Regeneron) in lymphoma was intitiated.
- A phase 2 study evaluating the combination of isatuximab
and atezolizumab (PD-L1 inhibitor mAb) in solid tumors was
initiated.
- A phase 2 study evaluating SAR440340 (an anti-IL33 mAb,
collaboration with Regeneron) in atopic dermatitis was
initiated.
- Positive primary analysis of the Phase 2b trial demonstrated
the safety and efficacy of SP0232/MEDI8897 (anti RSV mAb -
Respiratory Syncytial Virus, collaboration with Medimmune).
- Several projects in phase 2 were stopped:
- GZ389988, a TRKA antagonist, in osteo arthritis;
- ALX0171, an anti RSV nanobody (from Ablynx) for
Respiratory Syncitial Virus;
- SAR425899, a GLP-1 / GCGR agonist, in obesity in type 2
diabetes patients;
- SAR407899, a rho kinase inhibitor, for microvascular
angina;
Phase 1:
- SAR408701, an anti-CEACAM5, achieved positive proof of
concept in a subgroup of lung cancer patients. A broad development
program is expected to start by the end of 2019.
- BIVV001, a recombinant Factor VIII for Hemophilia A,
achieved positive proof of concept with demonstration of sustained
high factor levels at once-weekly dosing.
- SAR441000, a cytokine mRNA (collaboration withBioNTech
AG) entered phase 1 in the treatment of melanoma.
- SAR443060/DNL747 (collaboration with Denali), an oral
brain-penetrant small molecule (RIPK1 inhibitor), entered phase 1
clinical study in Amyotrophic Lateral Sclerosis (ALS) and
Alzheimer's disease.
- BIVV003, a Zinc Finger Nuclease (ZFN) gene editing
technology issued from Bioverativ entered phase 1 in the treatment
of sickle cell disease.
- SAR441344, an anti-CD40L mAb (license from ImmuNext),
entered phase 1 in the treatment of multiple sclerosis.
- A next generation Pneumococcal Conjugate Vaccine (PCV)
entered phase 1.
- Several projects in phase 1 were stopped:
- SAR439794, a TLR4 agonist immunomodulatory evaluated in
peanut allergy;
- SAR247799, a S1P1 agonist evaluated in
cardiovascular area;
- SAR438335, a GLP-1/GIP agonist in Type 2 diabetes;
- SAR228810, an anti protofibrillar AB mAb for Alzheimer
disease;
- UshStat®, a myosin 7A gene therapy for Usher Syndrome
1B, will be discontinued contigent upon identification of
out-licensing partner.
Collaborations
In January 2019, Sanofi and Regeneron announced
a restructuring of their global Immuno-Oncology Discovery and
Development Agreement for new IO cancer treatments. The 2015
agreement was scheduled to end in approximately mid-2020. This
revision provides for ongoing collaborative development of two
clinical-stage bispecific antibody programs (BCMAxCD3 and MUC16xCD3
bispecific). It also provides Sanofi with increased flexibility to
advance its early-stage IO pipeline independently while Regeneron
retains all rights to its other IO discovery and development
programs.
In January 2019, BioNTech announced that
it has extended its research collaboration with Sanofi initiated in
late 2015 in the field of mRNA cancer immunotherapy.
In January 2019, MyoKardia,
Inc. announced that it regained worldwide rights to all
programs covered under its license and collaboration agreement
with Sanofi. The collaboration has not been extended beyond
the initial research term, which ended on December 31, 2018.
As a result, MyoKardia now has regained global rights to
all programs in its portfolio, including mavacamten (a Myosin
inhibitor evaluated in obstructive and non-obstructive hypertrophic
cardiomyopathy) and MYK-491 (a Myosin activator evaluated in
dilated cardiomyopathy) and the license and collaboration will
conclude in its entirety effective April 1, 2019.
In December sanofi and Medicines for Malaria
Ventures (MMV) agreed to transfer the operational
responsibility for the development of Ferroquine/OZ439, to MMV in
such a way that MMV would assume leadership while sanofi remains
the sponsor of the studies, fulfilling drug supply, regulatory and
legal obligations. Ferroquine/OZ439 is a first in class combination
for malaria previously developed in collaboration with MMV.
In November, Sanofi announced that it plans to
collaborate with Denali Therapeutics Inc. on the development
of multiple molecules with the potential to treat a range of
neurological and systemic inflammatory diseases.
2018 Fourth-quarter and full-year financial
results(11)
Business Net Income(11)
In the fourth quarter of 2018, Sanofi generated
net sales of €8,997 million, an increase of 3.5% (up 3.9% at
CER). Full-year sales were €34,463 million, down 1.7% on a reported
basis (up 2.5% at CER).
Fourth-quarter other revenues increased
13.4% (up 10.3% at CER) to €329 million, reflecting the VaxServe
sales contribution of non-Sanofi products (€262 million, up 13.9%
at CER) and the royalties received from Swedish Orphan Biovitrum
AB. Full-year other revenues increased 5.7% (up 9.3% at CER) to
€1,214 million of which €959 million were generated by VaxServe (up
15.6% at CER).
Fourth-quarter Gross Profit increased
5.2% to €6,188 million (up 5.2% at CER). The gross margin ratio was
68.8% (68.6% at CER) versus 67.7% in the fourth quarter of 2017.
The positive mix impact of Specialty Care as well as the
contribution from Bioverativ and Vaccines (impacted by
Dengvaxia® in the fourth quarter of 2017) more than offset
the negative impacts from U.S. Diabetes net price evolution and
sevelamer generic competition. In the fourth quarter of 2018, the
gross margin ratio of segments was 72.1% for Pharmaceuticals (down
0.2 percentage points), 66.0% for CHC (up 1.6 percentage points)
and 60.4% for Vaccines (up 4.9 percentage points). Full-year Gross
Profit decreased 1.7% to €24,356 million (up 2.5% at CER). In 2018,
the gross margin ratio increased 0.1 percentage point to 70.7%
(70.6% at CER) versus 2017. In 2019, Sanofi expects its gross
margin ratio to be around 70% at CER.
Research and Development (R&D)
expenses increased 14.6% to €1,678 million in the fourth quarter of
2018. At CER, R&D expenses increased 13.5%, mainly reflecting
the acquisitions of Bioverativ and Ablynx together with the
investments in the immuno-oncology and diabetes programs. Excluding
the impact of acquisitions, R&D expenses would have risen by
6.7% in the fourth quarter of 2018. Full-year R&D expenses
increased 7.7% to €5,894 million (up 10.3% at CER).
Fourth-quarter selling general and
administrative expenses (SG&A) increased 0.8% to €2,721
million. At CER, SG&A expenses were up 1.1% mainly reflecting
consolidation of Bioverativ and Ablynx. Additional marketing
investments in new launches were offset by lower Diabetes expenses
in the U.S. In the fourth quarter, the ratio of SG&A to sales
decreased 0.9 percentage points to 30.2% compared to the fourth
quarter of 2017. Full-year SG&A expenses decreased 2.4% to
€9,831 million (up 1.6% at CER). In 2018, the ratio of SG&A to
sales was 28.5%, 0.2 percentage points lower than in 2017.
Fourth-quarter other current operating income
net of expenses was -€148 million versus -€114 million in the
fourth quarter of 2017 and included the share of profit/loss to
Regeneron of the monoclonal antibodies Alliance net of associated
marketing expenses incurred by Regeneron. In the fourth quarter of
2018, this line also included charges related to a legal
contingency provision, as well as a capital gain on an associate
company and other accruals, which in aggregate represented a net
charge of €72 million. In the fourth quarter of 2017, this line
included an impairment of tangible assets of €87 million related to
Dengvaxia®. In 2018, other current operating income net of
expenses was -€64 million versus €4 million in 2017.
The share of profits from associates was
€121 million in the fourth quarter versus €109 million for the same
period of 2017, reflecting the increased contribution of the share
of profits in Regeneron. In 2018, the share of profits from
associates was €423 million versus €214 million in 2017.
In the fourth quarter, non-controlling
interests were -€22 million versus -€30 million in the fourth
quarter of 2017. Full-year non-controlling interests were -€106
million versus -€125 million in 2017.
Fourth-quarter business operating income
increased 3.3% to €1,740 million. At CER, business operating income
increased 4.5%. The ratio of business operating income to net sales
decreased 0.1 percentage points to 19.3% versus the fourth quarter
of 2017. Over the period, the business operating income ratio of
segments was 27.1% for Pharmaceuticals (down 3.9 percentage
points), 29.0% for CHC (up 2.2 percentage points) and 36.1% for
Vaccines (up 14.2 percentage points). Full-year business operating
income was €8,884 million, down 4.7% (or up 0.9% at CER). In 2018,
the ratio of business operating income to net sales decreased by
0.8 percentage points to 25.8%.
Net financial expenses were -€60 million
in the fourth quarter versus -€73 million in the same period of
2017. In the fourth quarter of 2018, net financial expenses
included the cost associated with the Bioverativ and Ablynx
acquisitions coupled with an increase of €22 million in the market
value of a financial investment. Full-year net financial expenses
were -€271 million versus -€273 million in 2017.
The fourth-quarter effective tax rate was
20.0% compared to 18.7% in the fourth quarter of 2017. In 2018, the
effective tax rate was 21.6% compared to 23.5% in 2017.
Sanofi expects its effective tax rate to be around 22% in 2019.(11)
See Appendix 3 for 2018 fourth-quarter consolidated income
statement; see Appendix 10 for definitions of financial indicators,
and Appendix 4 for reconciliation of IFRS net income reported to
business net income.
Fourth-quarter business net income(11)
increased 2.9% to €1,364 million and 4.3% at CER. The ratio of
business net income to net sales was stable at 15.2% versus the
fourth quarter of 2017. In 2018, business net income(11) decreased
1.8% to €6,819 million and increased 4.2% at CER. The ratio of
business net income to net sales was stable at 19.8%.
In the fourth quarter of 2018, business earnings per
share(11) (EPS) increased by 3.8% to €1.10 on a reported basis
and by 4.7% at CER. The average number of shares outstanding was
1,245.6 million in the fourth quarter of 2018 versus 1,252.9
million in the fourth quarter of 2017. In 2018, business
earnings per share(11) was €5.47, down 0.9% on a reported basis
and up 5.1% at CER. The average number of shares outstanding was
1,247.1 million in 2018 versus 1,256.9 million in 2017. |
2019 Guidance
Sanofi expects 2019 Business EPS to grow between
3% and 5% at CER, barring unforeseen major adverse events. Applying
average January 2019 exchange rates, the positive currency impact
on 2019 Business EPS is estimated to be between 1% to 2%.
Dividend
The Board of Directors convened on February 6,
2019, and proposed a dividend of €3.07 per share.
Financial statements are not audited. The audit
procedures by the Statutory Auditors are underway.
Reconciliation of IFRS net income reported to
business net income (see Appendix 4)
In 2018, the IFRS net income was €4,306 million.
The main items excluded from the business net income were:
- An amortization charge of €2,170 million related to fair value
remeasurement on intangible assets of acquired companies (primarily
Aventis: €256 million, Genzyme: €760 million, Boehringer Ingelheim
CHC business: €242 million, Bioverativ: €430 million) and to
acquired intangible assets (licenses/products: €213 million). In
the fourth quarter, an amortization charge of €634 million related
to fair value remeasurement on intangible assets of acquired
companies (primarily Aventis: €56 million, Genzyme: €186 million,
Boehringer Ingelheim CHC business: €61 million, Bioverativ: €136
million) and to acquired intangible assets (licenses/products: €114
million) was recorded. These items have no cash impact on the
Company.
- An impairment of intangible assets of €718 million (of which
€426 million in the fourth quarter) mainly related to Lemtrada®,
intangible assets from the Ablynx acquisition in May 2018
(including the anticipated termination collaboration with Merck
& Co), and other Intellectual Property R&D assets of which
the rights related to programs in Myokardia portfolio. This item
has no cash impact on the Company.
- A charge of €114 million arising from the workdown of
inventories of acquired companies (related to Bioverativ)
remeasured at fair value due to the application of purchase
accounting to acquisitions. This item has no cash impact on the
Group.
- An income of €117 million mainly reflecting a decrease of Bayer
contingent considerations linked to Lemtrada® (income of €109
million) and a charge related to CVR fair value adjustment.
- Restructuring costs and similar items of €1,480 million (of
which €765 million in the fourth quarter) which include the
termination fee (€283 million) paid to Regeneron related to the
research program under the original IO agreement, streamlining
initiatives in Europe and Japan, the cost of transfer to Evotec of
the early stage infectious diseases R&D portfolio and Research
unit for an amount of €252 million and accelerated depreciation of
industrial assets in the U.S.
(11)
See Appendix 3 for 2018 fourth-quarter consolidated income
statement; see Appendix 10 for definitions of financial indicators,
and Appendix 4 for reconciliation of IFRS net income reported to
business net income.
- A €1,125 million tax effect arising from the items listed
above, mainly comprising €692 million of deferred taxes generated
by amortization and impairments of intangible assets, and €435
million associated with restructuring costs and similar items. The
fourth-quarter tax effect was €503 million, including €241 million
of deferred taxes on amortization and impairments charged against
intangible assets and €220 million associated with restructuring
costs and similar items (see Appendix 4).
- A €188 million tax effect (of which €56 million in the fourth
quarter) arising from the U.S. tax reform.
- An income of €76 million net of tax (of which €180 million in
the fourth quarter) 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 2018, net cash generated by operating
activities was €5,061 million after capital expenditures of €1,674
million and an increase in working capital of €1,099 million. In
2018, restructuring costs and similar items were €894 million while
expenditure on share repurchases was €1,104 million. Over the
period, the dividend paid by Sanofi amounted to €3,773 million and
acquisitions and partnerships net of disposals were €11,243 million
(including €12,728 million related to the Bioverativ and Ablynx
acquisitions and €1,598 million related to the European generics
business divestment). As a consequence, net debt increased from
€5,161 million at December 31, 2017, to €17,628 million at December
31, 2018 (amount net of €6,925 million in cash and cash
equivalents).
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, 2017. 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: |
2018 fourth-quarter and
2018 net sales by GBU, franchise, geographic region and
product |
Appendix
2: |
2018
fourth-quarter and 2018 business net income statement |
Appendix
3: |
2018
fourth-quarter and 2018 consolidated income statement |
Appendix
4: |
Reconciliation of IFRS net income reported to business net
income |
Appendix
5 Appendix 6 Appendix 7: Appendix 8: Appendix 9: |
Change
in net debt Simplified consolidated balance sheet Currency
sensitivity R&D pipeline Expected R&D milestones |
Appendix
10: |
Definitions of non-GAAP financial indicators |
Appendix 1: 2018 fourth-quarter net sales by GBU, franchise,
geographic region and product
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q4 2018 (€
million) |
Total GBUs |
%
CER |
%
reported |
Europe |
%
CER |
United States |
%
CER |
Rest of the World |
%
CER |
Emerging Markets |
%
CER |
Total Franchises |
%
CER |
%
reported |
Aubagio |
436 |
12
.4% |
15
.0% |
108 |
12
.5% |
311 |
13
.5% |
17 |
-5
.9% |
10 |
20
.0% |
446 |
12
.6% |
14
.7% |
Lemtrada |
87 |
-17
.1% |
-17
.1% |
37 |
-11
.9% |
45 |
-19
.6% |
5 |
-28
.6% |
9 |
28
.6% |
96 |
-14
.3% |
-14
.3% |
Total MS |
523 |
6
.0% |
8
.1% |
145 |
5
.1% |
356 |
7
.8% |
22 |
-12
.5% |
19 |
23
.5% |
542 |
6
.6% |
8
.2% |
Cerezyme |
127 |
-1
.6% |
-0
.8% |
72 |
-2
.7% |
47 |
4
.7% |
8 |
-18
.2% |
63 |
34
.5% |
190 |
9
.3% |
3
.8% |
Cerdelga |
43 |
31
.3% |
34
.4% |
16 |
87
.5% |
26 |
0
.0% |
1 |
- |
1 |
100
.0% |
44 |
33
.3% |
33
.3% |
Myozyme |
190 |
8
.0% |
9
.2% |
96 |
1
.1% |
79 |
18
.8% |
15 |
6
.7% |
36 |
25
.8% |
226 |
10
.7% |
10
.2% |
Fabrazyme |
180 |
9
.3% |
11
.1% |
45 |
4
.8% |
104 |
9
.9% |
31 |
13
.8% |
26 |
61
.1% |
206 |
14
.4% |
14
.4% |
Aldurazyme |
39 |
8
.3% |
8
.3% |
20 |
5
.3% |
12 |
20
.0% |
7 |
0
.0% |
15 |
41
.7% |
54 |
16
.7% |
12
.5% |
Total Rare
Disease |
644 |
6
.2% |
7
.9% |
262 |
3
.1% |
292 |
8
.5% |
90 |
8
.4% |
150 |
32
.6% |
794 |
10
.9% |
9
.4% |
Taxotere |
6 |
-25
.0% |
-25
.0% |
1 |
- |
-1 |
- |
6 |
-25
.0% |
32 |
3
.1% |
38 |
-2
.5% |
-5
.0% |
Jevtana |
109 |
16
.1% |
17
.2% |
41 |
10
.5% |
50 |
20
.0% |
18 |
20
.0% |
5 |
-16
.7% |
114 |
14
.1% |
15
.2% |
Eloxatine |
8 |
-12
.5% |
0
.0% |
0 |
-100
.0% |
0 |
- |
8 |
0
.0% |
35 |
2
.8% |
43 |
0
.0% |
-2
.3% |
Thymoglobulin |
59 |
7
.4% |
9
.3% |
9 |
0
.0% |
43 |
5
.0% |
7 |
40
.0% |
19 |
17
.6% |
78 |
9
.9% |
9
.9% |
Mozobil |
44 |
16
.2% |
18
.9% |
12 |
18
.2% |
26 |
18
.2% |
6 |
0
.0% |
3 |
0
.0% |
47 |
15
.0% |
17
.5% |
Total
Oncology |
286 |
9
.3% |
10
.4% |
89 |
10
.8% |
141 |
8
.7% |
56 |
8
.0% |
101 |
5
.0% |
387 |
8
.1% |
7
.8% |
Dupixent |
278 |
128
.8% |
135
.6% |
29 |
2800
.0% |
225 |
87
.9% |
24 |
2200
.0% |
2 |
- |
280 |
130
.5% |
137
.3% |
Kevzara |
31 |
275
.0% |
287
.5% |
6 |
500
.0% |
23 |
214
.3% |
2 |
- |
0 |
- |
31 |
275
.0% |
287
.5% |
Total
Immunology |
309 |
138
.1% |
145
.2% |
35 |
- |
248 |
95
.1% |
26 |
- |
2 |
- |
311 |
139
.7% |
146
.8% |
Alprolix |
95 |
- |
- |
0 |
- |
76 |
- |
19 |
- |
0 |
- |
95 |
- |
- |
Eloctate |
194 |
- |
- |
0 |
- |
160 |
- |
34 |
- |
2 |
- |
196 |
- |
- |
Total Hemophilia
Rare blood disorders |
292 |
- |
- |
3 |
- |
236 |
- |
53 |
- |
2 |
- |
294 |
- |
- |
Sanofi Genzyme
(Specialty Care) |
2,054 |
37
.4% |
40
.1% |
534 |
12
.6% |
1,273 |
48
.8% |
247 |
52
.5% |
274 |
22
.4% |
2,328 |
35
.2% |
36
.0% |
Lantus |
624 |
-27
.3% |
-25
.9% |
168 |
-8
.2% |
379 |
-37
.0% |
77 |
1
.3% |
242 |
7
.7% |
866 |
-19
.7% |
-19
.5% |
Toujeo |
180 |
-6
.8% |
-5
.8% |
77 |
23
.8% |
81 |
-29
.1% |
22 |
22
.2% |
31 |
32
.0% |
211 |
-2
.3% |
-2
.3% |
Apidra |
60 |
-13
.0% |
-13
.0% |
34 |
0
.0% |
17 |
-36
.0% |
9 |
0
.0% |
29 |
10
.7% |
89 |
-6
.2% |
-8
.2% |
Amaryl |
11 |
-14
.3% |
-21
.4% |
4 |
-20
.0% |
1 |
0
.0% |
6 |
-12
.5% |
66 |
1
.5% |
77 |
-1
.3% |
-3
.8% |
Admelog |
57 |
5400
.0% |
5600
.0% |
2 |
100
.0% |
54 |
- |
1 |
- |
0 |
- |
57 |
5400
.0% |
5600
.0% |
Total
Diabetes |
999 |
-16
.2% |
-14
.6% |
320 |
-0
.6% |
555 |
-26
.3% |
124 |
4
.3% |
376 |
7
.7% |
1,375 |
-10
.5% |
-10
.3% |
Multaq |
93 |
22
.7% |
24
.0% |
10 |
0
.0% |
82 |
23
.1% |
1 |
- |
2 |
-50
.0% |
95 |
20
.8% |
23
.4% |
Praluent |
78 |
48
.1% |
50
.0% |
23 |
53
.3% |
52 |
45
.7% |
3 |
50
.0% |
4 |
200
.0% |
82 |
50
.9% |
54
.7% |
Total
Cardiovascular |
171 |
33
.1% |
34
.6% |
33 |
32
.0% |
134 |
31
.0% |
4 |
150
.0% |
6 |
33
.3% |
177 |
33
.1% |
36
.2% |
Diabetes &
Cardiovascular |
1,170 |
-11
.3% |
-9
.8% |
353 |
1
.7% |
689 |
-19
.4% |
128 |
6
.7% |
382 |
7
.9% |
1,552 |
-7
.1% |
-6
.7% |
Plavix |
328 |
-4
.9% |
-5
.7% |
37 |
2
.9% |
0 |
-100
.0% |
53 |
-23
.5% |
238 |
-0
.4% |
328 |
-4
.9% |
-5
.7% |
Lovenox |
346 |
-9
.0% |
-10
.8% |
199 |
-13
.9% |
9 |
-28
.6% |
21 |
-13
.0% |
117 |
3
.3% |
346 |
-9
.0% |
-10
.8% |
Renagel / Renvela |
96 |
-39
.4% |
-38
.1% |
14 |
-18
.8% |
57 |
-53
.0% |
8 |
28
.6% |
17 |
13
.3% |
96 |
-39
.4% |
-38
.1% |
Aprovel |
151 |
-2
.5% |
-4
.4% |
27 |
-3
.7% |
3 |
50
.0% |
9 |
-54
.2% |
112 |
8
.6% |
151 |
-2
.5% |
-4
.4% |
Allegra |
26 |
-21
.9% |
-18
.8% |
1 |
-50
.0% |
0 |
- |
25 |
-20
.0% |
0 |
- |
26 |
-21
.9% |
-18
.8% |
Myslee / Ambien / Stilnox |
59 |
-1
.7% |
0
.0% |
11 |
10
.0% |
12 |
-26
.7% |
21 |
-13
.0% |
15 |
45
.5% |
59 |
-1
.7% |
0
.0% |
Synvisc / Synvisc One |
81 |
-7
.0% |
-5
.8% |
7 |
0
.0% |
55 |
-13
.1% |
3 |
0
.0% |
16 |
14
.3% |
81 |
-7
.0% |
-5
.8% |
Depakine |
109 |
-0
.9% |
-2
.7% |
39 |
-2
.4% |
0 |
- |
5 |
-25
.0% |
65 |
1
.5% |
109 |
-0
.9% |
-2
.7% |
Tritace |
54 |
-8
.2% |
-11
.5% |
35 |
-7
.7% |
0 |
- |
1 |
-50
.0% |
18 |
-5
.0% |
54 |
-8
.2% |
-11
.5% |
Other Rx Drugs |
876 |
-2
.3% |
-4
.1% |
447 |
-4
.3% |
49 |
-4
.2% |
94 |
-4
.2% |
286 |
1
.7% |
876 |
-2
.3% |
-4
.1% |
Total Established Rx
Products |
2,126 |
-6
.8% |
-8
.0% |
817 |
-6
.8% |
185 |
-31
.0% |
240 |
-16
.0% |
884 |
2
.9% |
2,126 |
-6
.8% |
-8
.0% |
Generics |
270 |
-33
.8% |
-37
.5% |
32 |
-82
.9% |
45 |
5
.0% |
20 |
0
.0% |
173 |
3
.8% |
270 |
-33
.8% |
-37
.5% |
Total Emerging
Markets Specialty Care |
274 |
22
.4% |
11
.4% |
0 |
- |
0 |
- |
19 |
23
.5% |
274 |
22
.4% |
274 |
0 |
0 |
Total Emerging
Markets Diabetes & Cardiovascular |
382 |
7
.9% |
4
.4% |
0 |
|
0 |
|
0 |
|
382 |
7
.9% |
0
.0% |
|
|
General Medicines
& Emerging Markets |
3,052 |
-6
.6% |
-9
.1% |
849 |
-20
.2% |
230 |
-26
.2% |
260 |
-14
.9% |
1,713 |
6
.9% |
2,396 |
-11
.1% |
-12
.7% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Pharmaceuticals |
6,276 |
3
.0% |
2
.6% |
1,736 |
-7
.8% |
2,192 |
8
.5% |
635 |
7
.9% |
1,713 |
6
.9% |
6,276 |
3
.0% |
2
.6% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy, Cough and Cold |
268 |
-6
.3% |
-6
.6% |
91 |
-13
.3% |
62 |
-4
.8% |
29 |
11
.1% |
86 |
-4
.3% |
268 |
-6
.3% |
-6
.6% |
Pain |
336 |
4
.6% |
2
.1% |
147 |
3
.5% |
45 |
10
.0% |
33 |
3
.3% |
111 |
4
.3% |
336 |
4
.6% |
2
.1% |
Digestive |
256 |
4
.4% |
2
.4% |
82 |
0
.0% |
53 |
10
.9% |
12 |
-18
.8% |
109 |
8
.5% |
256 |
4
.4% |
2
.4% |
Nutritional |
174 |
9
.1% |
6
.1% |
33 |
3
.1% |
10 |
0
.0% |
62 |
3
.2% |
69 |
19
.7% |
174 |
9
.1% |
6
.1% |
Consumer
Healthcare |
1,194 |
1
.9% |
0
.5% |
368 |
-3
.6% |
274 |
6
.0% |
147 |
-2
.7% |
405 |
6
.4% |
1,194 |
1
.9% |
0
.5% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
504 |
3
.0% |
2
.2% |
83 |
-2
.4% |
102 |
-9
.2% |
32 |
-24
.4% |
287 |
14
.3% |
504 |
3
.0% |
2
.2% |
Adult Booster Vaccines |
135 |
-2
.9% |
-1
.5% |
33 |
-8
.3% |
76 |
-6
.3% |
8 |
0
.0% |
18 |
26
.7% |
135 |
-2
.9% |
-1
.5% |
Meningitis/Pneumonia |
131 |
59
.3% |
61
.7% |
0 |
- |
80 |
45
.3% |
5 |
0
.0% |
46 |
104
.3% |
131 |
59
.3% |
61
.7% |
Influenza Vaccines |
596 |
17
.1% |
18
.7% |
93 |
95
.8% |
411 |
24
.1% |
26 |
212
.5% |
66 |
-44
.7% |
596 |
17
.1% |
18
.7% |
Travel And Other Endemics Vaccines |
130 |
-18
.8% |
-18
.8% |
27 |
7
.7% |
33 |
-32
.7% |
15 |
7
.7% |
55 |
-23
.6% |
130 |
-18
.8% |
-18
.8% |
Vaccines |
1,527 |
9
.7% |
10
.3% |
238 |
21
.9% |
729 |
10
.4% |
87 |
15
.8% |
473 |
2
.5% |
1,527 |
9
.7% |
10
.3% |
Total
Company |
8,997 |
3
.9% |
3
.5% |
2,342 |
-4
.8% |
3,195 |
8
.7% |
869 |
6
.7% |
2,591 |
6
.0% |
8,997 |
3
.9% |
3
.5% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2018 net sales by GBU, franchise, geographic
region and product
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2018 (€
million) |
Total GBUs |
%
CER |
%
reported |
Europe |
%
CER |
United States |
%
CER |
Rest of the World |
%
CER |
Emerging Markets |
%
CER |
Total Franchises |
%
CER |
%
reported |
Aubagio |
1,599 |
8
.0% |
4
.5% |
385 |
-0
.3% |
1,157 |
11
.4% |
57 |
0
.0% |
48 |
59
.5% |
1,647 |
9
.3% |
5
.1% |
Lemtrada |
375 |
-14
.0% |
-16
.7% |
167 |
-3
.4% |
189 |
-19
.1% |
19 |
-33
.3% |
27 |
33
.3% |
402 |
-11
.6% |
-15
.2% |
Total MS |
1,974 |
3
.0% |
-0
.3% |
552 |
-1
.2% |
1,346 |
5
.8% |
76 |
-11
.2% |
75 |
49
.2% |
2,049 |
4
.4% |
0
.4% |
Cerezyme |
481 |
-1
.8% |
-4
.0% |
270 |
-3
.6% |
174 |
2
.8% |
37 |
-9
.3% |
230 |
24
.3% |
711 |
6
.4% |
-2
.7% |
Cerdelga |
156 |
28
.8% |
24
.8% |
51 |
96
.2% |
98 |
7
.4% |
7 |
100
.0% |
3 |
300
.0% |
159 |
31
.0% |
26
.2% |
Myozyme |
716 |
8
.8% |
6
.4% |
374 |
6
.5% |
284 |
13
.0% |
58 |
3
.4% |
124 |
22
.4% |
840 |
10
.8% |
6
.5% |
Fabrazyme |
673 |
7
.9% |
4
.5% |
175 |
7
.4% |
383 |
8
.1% |
115 |
8
.0% |
82 |
25
.6% |
755 |
9
.8% |
4
.6% |
Aldurazyme |
144 |
4
.2% |
1
.4% |
76 |
1
.3% |
44 |
9
.5% |
24 |
4
.0% |
62 |
12
.1% |
206 |
6
.7% |
-1
.0% |
Total Rare
Disease |
2,416 |
5
.3% |
2
.6% |
1,008 |
5
.3% |
1,072 |
5
.8% |
336 |
3
.6% |
542 |
21
.5% |
2,958 |
8
.3% |
2
.4% |
Taxotere |
32 |
-13
.5% |
-13
.5% |
3 |
0
.0% |
1 |
- |
28 |
-17
.6% |
134 |
2
.9% |
166 |
-0
.6% |
-4
.0% |
Jevtana |
399 |
13
.9% |
10
.8% |
158 |
7
.4% |
179 |
17
.6% |
62 |
20
.8% |
23 |
0
.0% |
422 |
13
.0% |
9
.3% |
Eloxatine |
32 |
-3
.0% |
-3
.0% |
2 |
-50
.0% |
0 |
-100
.0% |
30 |
7
.1% |
150 |
6
.8% |
182 |
5
.0% |
1
.7% |
Thymoglobulin |
222 |
2
.7% |
-0
.9% |
37 |
-5
.1% |
162 |
4
.9% |
23 |
0
.0% |
75 |
22
.7% |
297 |
7
.2% |
2
.4% |
Mozobil |
161 |
7
.8% |
4
.5% |
47 |
9
.1% |
96 |
5
.2% |
18 |
21
.4% |
10 |
22
.2% |
171 |
8
.6% |
4
.9% |
Total
Oncology |
1,075 |
-0
.4% |
-3
.2% |
351 |
4
.1% |
523 |
-6
.8% |
201 |
12
.2% |
419 |
8
.8% |
1,494 |
2
.1% |
-1
.5% |
Dupixent |
783 |
265
.8% |
257
.5% |
75 |
3650
.0% |
660 |
213
.9% |
48 |
4700
.0% |
5 |
- |
788 |
268
.0% |
259
.8% |
Kevzara |
83 |
663
.6% |
654
.5% |
14 |
1300
.0% |
64 |
550
.0% |
5 |
- |
0 |
- |
83 |
663
.6% |
654
.5% |
Total
Immunology |
866 |
284
.8% |
276
.5% |
89 |
- |
724 |
228
.8% |
53 |
- |
5 |
- |
871 |
287
.0% |
278
.7% |
Alprolix |
285 |
- |
- |
0 |
- |
222 |
- |
63 |
- |
0 |
- |
285 |
- |
- |
Eloctate |
606 |
- |
- |
0 |
- |
500 |
- |
106 |
- |
2 |
- |
608 |
- |
- |
Total Hemophilia
Rare blood disorders |
895 |
- |
- |
4 |
- |
722 |
- |
169 |
- |
2 |
- |
897 |
- |
- |
Sanofi Genzyme
(Specialty Care) |
7,226 |
30
.8% |
27
.4% |
2,004 |
7
.9% |
4,387 |
42
.3% |
835 |
40
.9% |
1,043 |
18
.7% |
8,269 |
29
.0% |
23
.8% |
Lantus |
2,588 |
-25
.8% |
-28
.4% |
684 |
-9
.7% |
1,614 |
-33
.3% |
290 |
-3
.8% |
977 |
5
.3% |
3,565 |
-19
.0% |
-22
.9% |
Toujeo |
710 |
-0
.9% |
-3
.7% |
290 |
34
.6% |
344 |
-20
.7% |
76 |
18
.5% |
130 |
83
.5% |
840 |
7
.2% |
2
.9% |
Apidra |
248 |
-9
.0% |
-11
.1% |
136 |
0
.0% |
74 |
-23
.5% |
38 |
-2
.4% |
109 |
26
.5% |
357 |
0
.3% |
-5
.3% |
Amaryl |
47 |
-16
.9% |
-20
.3% |
17 |
-19
.0% |
2 |
0
.0% |
28 |
-16
.7% |
288 |
9
.4% |
335 |
4
.8% |
-0
.3% |
Admelog |
93 |
9100
.0% |
9200
.0% |
7 |
600
.0% |
86 |
- |
0 |
- |
0 |
- |
93 |
9100
.0% |
9200
.0% |
Total
Diabetes |
3,918 |
-17
.5% |
-20
.0% |
1,272 |
-0
.9% |
2,185 |
-26
.9% |
461 |
-0
.8% |
1,554 |
12
.7% |
5,472 |
-10
.4% |
-14
.5% |
Multaq |
343 |
7
.2% |
3
.3% |
43 |
2
.4% |
296 |
8
.0% |
4 |
0
.0% |
7 |
0
.0% |
350 |
7
.1% |
3
.2% |
Praluent |
250 |
53
.3% |
49
.7% |
86 |
87
.0% |
154 |
37
.1% |
10 |
120
.0% |
11 |
175
.0% |
261 |
56
.1% |
52
.6% |
Total
Cardiovascular |
593 |
22
.6% |
18
.8% |
129 |
46
.6% |
450 |
16
.4% |
14 |
66
.7% |
18 |
63
.6% |
611 |
23
.5% |
19
.8% |
Diabetes &
Cardiovascular |
4,511 |
-13
.8% |
-16
.4% |
1,401 |
2
.2% |
2,635 |
-22
.0% |
475 |
0
.4% |
1,572 |
13
.1% |
6,083 |
-7
.9% |
-11
.9% |
Plavix |
1,440 |
1
.2% |
-2
.0% |
147 |
-2
.0% |
0 |
-100
.0% |
218 |
-23
.5% |
1,075 |
8
.8% |
1,440 |
1
.2% |
-2
.0% |
Lovenox |
1,465 |
-3
.0% |
-6
.9% |
870 |
-8
.3% |
38 |
-29
.3% |
81 |
-6
.6% |
476 |
11
.4% |
1,465 |
-3
.0% |
-6
.9% |
Renagel / Renvela |
411 |
-46
.7% |
-48
.7% |
60 |
-15
.5% |
253 |
-59
.1% |
31 |
-8
.6% |
67 |
42
.0% |
411 |
-46
.7% |
-48
.7% |
Aprovel |
652 |
-1
.7% |
-5
.5% |
108 |
-6
.1% |
10 |
0
.0% |
69 |
-45
.5% |
465 |
12
.7% |
652 |
-1
.7% |
-5
.5% |
Allegra |
124 |
-17
.7% |
-21
.5% |
8 |
-11
.1% |
0 |
- |
116 |
-18
.1% |
0 |
- |
124 |
-17
.7% |
-21
.5% |
Myslee / Ambien / Stilnox |
231 |
-6
.9% |
-10
.8% |
39 |
-2
.5% |
45 |
-14
.5% |
86 |
-16
.0% |
61 |
13
.8% |
231 |
-6
.9% |
-10
.8% |
Synvisc / Synvisc One |
313 |
-15
.0% |
-19
.1% |
25 |
-16
.7% |
217 |
-22
.3% |
13 |
0
.0% |
58 |
23
.5% |
313 |
-15
.0% |
-19
.1% |
Depakine |
452 |
4
.7% |
1
.1% |
163 |
-1
.2% |
0 |
- |
14 |
-6
.7% |
275 |
9
.0% |
452 |
4
.7% |
1
.1% |
Tritace |
221 |
-3
.8% |
-7
.9% |
142 |
-5
.9% |
0 |
- |
5 |
0
.0% |
74 |
0
.0% |
221 |
-3
.8% |
-7
.9% |
Other Rx Drugs |
3,534 |
-2
.5% |
-6
.8% |
1,768 |
-2
.0% |
188 |
-6
.3% |
376 |
-7
.1% |
1,202 |
-1
.1% |
3,534 |
-2
.5% |
-6
.8% |
Total Established Rx
Products |
8,843 |
-6
.1% |
-9
.9% |
3,330 |
-4
.4% |
751 |
-38
.2% |
1,009 |
-16
.9% |
3,753 |
6
.6% |
8,843 |
-6
.1% |
-9
.9% |
Generics |
1,490 |
-9
.8% |
-15
.8% |
568 |
-24
.4% |
124 |
-15
.3% |
113 |
9
.1% |
685 |
3
.0% |
1,490 |
-9
.8% |
-15
.8% |
Total Emerging
Markets Specialty Care |
1,043 |
18
.7% |
3
.9% |
0 |
- |
0 |
- |
75 |
49
.2% |
1,043 |
18
.7% |
|
|
|
Total Emerging
Markets Diabetes & Cardiovascular |
1,572 |
13
.1% |
4
.2% |
|
|
|
|
|
|
1,572 |
13
.1% |
|
|
|
General Medicines
& Emerging Markets |
12,948 |
-2
.8% |
-8
.2% |
3,898 |
-7
.9% |
875 |
-35
.8% |
1,122 |
-14
.8% |
7,053 |
9
.3% |
10,333 |
-6
.7% |
-10
.8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Pharmaceuticals |
24,685 |
2
.4% |
-1
.9% |
7,303 |
-2
.1% |
7,897 |
0
.9% |
2,432 |
1
.9% |
7,053 |
9
.3% |
24,685 |
2
.4% |
-1
.9% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy, Cough and Cold |
1,124 |
-1
.7% |
-6
.7% |
347 |
-0
.9% |
303 |
-12
.3% |
135 |
2
.9% |
339 |
6
.9% |
1,124 |
-1
.7% |
-6
.7% |
Pain |
1,254 |
6
.7% |
-0
.6% |
521 |
1
.8% |
165 |
3
.6% |
119 |
3
.4% |
449 |
14
.0% |
1,254 |
6
.7% |
-0
.6% |
Digestive |
986 |
8
.7% |
3
.4% |
314 |
2
.6% |
195 |
8
.5% |
54 |
1
.8% |
423 |
14
.4% |
986 |
8
.7% |
3
.4% |
Nutritional |
675 |
4
.7% |
-1
.5% |
125 |
5
.9% |
37 |
-5
.0% |
256 |
5
.9% |
257 |
4
.4% |
675 |
4
.7% |
-1
.5% |
Consumer
Healthcare |
4,660 |
3
.0% |
-2
.9% |
1,403 |
-0
.2% |
1,066 |
-1
.1% |
603 |
2
.1% |
1,588 |
8
.9% |
4,660 |
3
.0% |
-2
.9% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
1,749 |
-0
.7% |
-4
.3% |
296 |
-1
.0% |
397 |
-4
.8% |
156 |
5
.9% |
900 |
0
.3% |
1,749 |
-0
.7% |
-4
.3% |
Adult Booster Vaccines |
470 |
1
.3% |
-0
.8% |
129 |
9
.2% |
273 |
-4
.1% |
26 |
0
.0% |
42 |
18
.9% |
470 |
1
.3% |
-0
.8% |
Meningitis/Pneumonia |
609 |
0
.6% |
-2
.2% |
0 |
-100
.0% |
466 |
-1
.6% |
16 |
-50
.0% |
127 |
29
.1% |
609 |
0
.6% |
-2
.2% |
Influenza Vaccines |
1,708 |
7
.2% |
7
.5% |
177 |
57
.5% |
1,233 |
7
.5% |
81 |
62
.7% |
217 |
-22
.9% |
1,708 |
7
.2% |
7
.5% |
Travel And Other Endemics Vaccines |
488 |
1
.8% |
-1
.0% |
117 |
31
.1% |
134 |
-10
.3% |
56 |
7
.4% |
181 |
-3
.6% |
488 |
1
.8% |
-1
.0% |
Vaccines |
5,118 |
2
.4% |
0
.3% |
728 |
16
.0% |
2,577 |
1
.1% |
342 |
9
.5% |
1,471 |
-2
.3% |
5,118 |
2
.4% |
0
.3% |
Total
Company |
34,463 |
2
.5% |
-1
.7% |
9,434 |
-0
.6% |
11,540 |
0
.7% |
3,377 |
2
.7% |
10,112 |
7
.5% |
34,463 |
2
.5% |
-1
.7% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Appendix 2: Business net income
statement
Fourth Quarter
2018 |
Pharmaceuticals |
Consumer Healthcare |
Vaccines |
Others(2) |
Total Group |
€ million |
Q4
2018 |
Q4
2017(1) |
Cha-
nge |
Q4
2018 |
Q4
2017(1) |
Cha-
nge |
Q4
2018 |
Q4
2017(1) |
Cha-
nge |
Q4
2018 |
Q4
2017(1) |
Cha-
nge |
Q4
2018 |
Q4
2017(1) |
Cha-
nge |
Net sales |
6
,276 |
6
,119 |
2
.6% |
1
,194 |
1
,188 |
0
.5% |
1
,527 |
1
,385 |
10
.3% |
- |
- |
|
8
,997 |
8
,692 |
3
.5% |
Other revenues |
67 |
66 |
1
.5% |
- |
- |
|
262 |
224 |
17
.0% |
- |
- |
|
329 |
290 |
13
.4% |
Cost of Sales |
(1
,820) |
(1
,760) |
3
.4% |
(406) |
(423) |
(4
.0)% |
(866) |
(841) |
3
.0% |
(46) |
(75) |
(38
.7)% |
(3
,138) |
(3
,099) |
1
.3% |
As % of net sales |
(29
.0)% |
(28
.8)% |
|
(34
.0)% |
(35
.6)% |
|
(56
.7)% |
(60
.7)% |
|
|
|
|
(34
.9)% |
(35
.7)% |
|
Gross
Profit |
4
,523 |
4
,425 |
2
.2% |
788 |
765 |
3
.0% |
923 |
768 |
20
.2% |
(46) |
(75) |
(38
.7%) |
6
,188 |
5
,883 |
5
.2% |
As % of net
sales |
72
.1% |
72
.3% |
|
66
.0% |
64
.4% |
|
60
.4% |
55
.5% |
|
|
|
|
68
.8% |
67
.7% |
|
Research and
development expenses |
(1
,311) |
(1
,067) |
22
.9% |
(48) |
(41) |
17
.1% |
(162) |
(166) |
(2
.4)% |
(157) |
(190) |
(17
.4)% |
(1
,678) |
(1
,464) |
14
.6% |
As % of net
sales |
(20
.9)% |
(17
.4)% |
|
(4
.0)% |
(3
.5)% |
|
(10
.6)% |
(12
.0)% |
|
|
|
|
(18
.7)% |
(16
.8)% |
|
Selling and general
expenses |
(1
,485) |
(1
,523) |
(2
.5)% |
(409) |
(406) |
0
.7% |
(210) |
(197) |
6
.6% |
(617) |
(573) |
7
.7% |
(2
,721) |
(2
,699) |
0
.8% |
As % of net
sales |
(23
.7)% |
(24
.9)% |
|
(34
.3)% |
(34
.2)% |
|
(13
.8)% |
(14
.2)% |
|
|
|
|
(30
.2)% |
(31
.1)% |
|
Other current operating
income/ expenses |
(123) |
(19) |
|
16 |
2 |
|
(1) |
(100) |
|
(40) |
3 |
|
(148) |
(114) |
|
Share of profit/loss of
associates* and joint-ventures |
120 |
109 |
|
- |
1 |
|
1 |
(1) |
|
- |
- |
|
121 |
109 |
|
Net income attributable
to non controlling interests |
(21) |
(26) |
|
(1) |
(3) |
|
- |
(1) |
|
- |
- |
|
(22) |
(30) |
|
Business operating
income |
1
,703 |
1
,899 |
(10
.3)% |
346 |
318 |
8
.8% |
551 |
303 |
81
.8% |
(860) |
(835) |
3
.0% |
1
,740 |
1
,685 |
3
.3% |
As % of net
sales |
27
.1% |
31
.0% |
|
29
.0% |
26
.8% |
|
36
.1% |
21
.9% |
|
|
|
|
19
.3% |
19
.4% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
income and expenses |
(60) |
(73) |
|
|
|
|
|
|
|
|
Income tax
expenses |
|
(316) |
(287) |
|
|
|
|
|
|
|
|
Tax
rate** |
|
20
.0% |
18
.7% |
|
|
|
|
|
|
|
|
Business
net income |
|
1
,364 |
1
,325 |
2
.9% |
|
|
|
|
|
|
|
As % of
net sales |
|
15
.2% |
15
.2% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business
earnings / share (in euros)*** |
1
.10 |
1
.06 |
3
.8% |
* 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 1,245.6 million in the
fourth quarter of 2018 and 1,252.9 million in the fourth quarter of
2017.(1) Includes the effects of first-time application of IFRS 15
on revenue recognition, effective January 1, 2018.(2) Other
includes the cost of Global Support Functions (Medical Affairs,
External Affairs, Finance, Human Resources, Information Solution
& Technologies, Sanofi Business Services, etc.).
Full year 2018 |
Pharmaceuticals |
Consumer Healthcare |
Vaccines |
Others (2) |
Total Group |
€ million |
2018 |
2017(1) |
Cha-
nge |
2018 |
2017(1) |
Cha-
nge |
2018 |
2017(1) |
Cha-
nge |
2018 |
2017(1) |
Cha-
nge |
2018 |
2017(1) |
Cha-
nge |
Net sales |
24 ,685 |
25 ,173 |
(1 .9)% |
4 ,660 |
4 ,798 |
(2 .9)% |
5 ,118 |
5 ,101 |
0 .3% |
- |
- |
|
34 ,463 |
35 ,072 |
(1 .7)% |
Other revenues |
252 |
287 |
(12
.2)% |
- |
- |
|
962 |
862 |
11
.6% |
- |
- |
|
1
,214 |
1
,149 |
5
.7% |
Cost of Sales |
(6
,738) |
(6
,766) |
(0
.4)% |
(1
,539) |
(1
,612) |
(4
.5)% |
(2
,854) |
(2
,798) |
2
.0% |
(190) |
(271) |
(29
.9)% |
(11
,321) |
(11
,447) |
(1
.1)% |
As % of net sales |
(27
.3)% |
(26
.9)% |
|
(33
.0)% |
(33
.6)% |
|
(55
.8)% |
(54
.9)% |
|
|
|
|
(32
.8)% |
(32
.6)% |
|
Gross
Profit |
18 ,199 |
18 ,694 |
(2 .6)% |
3 ,121 |
3 ,186 |
(2 .0)% |
3 ,226 |
3 ,165 |
1 .9% |
(190) |
(271) |
(29 .9%) |
24 ,356 |
24 ,774 |
(1 .7)% |
As % of net
sales |
73 .7% |
74 .3% |
|
67 .0% |
66 .4% |
|
63 .0% |
62 .0% |
|
|
|
|
70 .7% |
70 .6% |
|
Research and
development expenses |
(4
,572) |
(4
,056) |
12
.7% |
(143) |
(123) |
16
.3% |
(555) |
(557) |
(0
.4)% |
(624) |
(736) |
(15
.2)% |
(5
,894) |
(5
,472) |
7
.7% |
As % of net sales |
(18
.5)% |
(16
.1)% |
|
(3
.1)% |
(2
.6)% |
|
(10
.8)% |
(10
.9)% |
|
|
|
|
(17
.1)% |
(15
.6)% |
|
Selling and general
expenses |
(5
,431) |
(5
,649) |
(3
.9)% |
(1
,534) |
(1
,645) |
(6
.7)% |
(710) |
(728) |
(2
.5)% |
(2
,156) |
(2
,050) |
5
.2% |
(9
,831) |
(10
,072) |
(2
.4)% |
As % of net sales |
(22
.0)% |
(22
.4)% |
|
(32
.9)% |
(34
.3)% |
|
(13
.9)% |
(14
.3)% |
|
|
|
|
(28
.5)% |
(28
.7)% |
|
Other current operating
income/ expenses |
(37) |
34 |
|
101 |
94 |
|
(4) |
(107) |
|
(124) |
(17) |
|
(64) |
4 |
|
Share of profit/loss of
associates* and joint-ventures |
425 |
212 |
|
1 |
1 |
|
(3) |
1 |
|
- |
- |
|
423 |
214 |
|
Net income attributable
to non controlling interests |
(96) |
(110) |
|
(10) |
(15) |
|
- |
- |
|
- |
- |
|
(106) |
(125) |
|
Business operating
income |
8 ,488 |
9 ,125 |
(7 .0)% |
1 ,536 |
1 ,498 |
2 .5% |
1 ,954 |
1 ,774 |
10 .1% |
(3 ,094) |
(3 ,074) |
0 .7% |
8 ,884 |
9 ,323 |
(4 .7)% |
As % of net
sales |
34 .4% |
36 .2% |
|
33 .0% |
31 .2% |
|
38 .2% |
34 .8% |
|
|
|
|
25 .8% |
26 .6% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
income and expenses |
(271) |
(273) |
|
|
|
|
|
|
|
|
Income tax
expenses |
|
|
|
(1
,794) |
(2
,107) |
|
|
|
|
|
|
|
|
Tax
rate** |
|
21
.6% |
23
.5% |
|
|
|
|
|
|
|
|
Business
net income |
|
6 ,819 |
6 ,943 |
(1 .8)% |
|
|
|
|
|
|
|
As % of
net sales |
|
19 .8% |
19 .8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business
earnings / share (in euros)*** |
5 .47 |
5 .52 |
(0 .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 1,247.1 million in 2018
and 1,256.9 million in 2017.(1) Includes the effects of first-time
application of IFRS 15 on revenue recognition, effective January 1,
2018.(2) 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 |
Q4
2018 |
Q4
2017(1) |
2018 |
2017(1) |
Net sales |
8,997 |
8,692 |
34,463 |
35,072 |
Other revenues |
329 |
290 |
1,214 |
1,149 |
Cost of sales |
(3,138) |
(3,089) |
(11,435) |
(11,613) |
Gross
profit |
6,188 |
5,893 |
24,242 |
24,608 |
Research and development expenses |
(1,678) |
(1,464) |
(5,894) |
(5,472) |
Selling and general expenses |
(2,730) |
(2,699) |
(9,859) |
(10,072) |
Other operating income |
83 |
10 |
484 |
237 |
Other operating expenses |
(231) |
(124) |
(548) |
(233) |
Amortization of intangible assets |
(634) |
(442) |
(2,170) |
(1,866) |
Impairment of intangible assets |
(426) |
(262) |
(718) |
(293) |
Fair value remeasurement of contingent consideration |
- |
15 |
117 |
(159) |
Restructuring costs and similar items |
(765) |
(118) |
(1,480) |
(731) |
Other gains and losses, and litigation |
(7) |
(61) |
502 |
(215) |
Operating
income |
(200) |
748 |
4,676 |
5,804 |
Financial expenses |
(103) |
(99) |
(435) |
(420) |
Financial income |
43 |
26 |
164 |
147 |
Income before tax
and associates and joint ventures |
(260) |
675 |
4,405 |
5,531 |
Income tax expense |
243 |
(699) |
(481) |
(1,722) |
Share of profit/(loss) of associates and joint ventures |
301 |
21 |
499 |
85 |
Net income excluding
the exchanged/held-for-exchange Animal Health business |
284 |
(3) |
4,423 |
3,894 |
Net
income/(loss) of the exchanged/held-for-exchange Animal Health
business(2) |
(9) |
159 |
(13) |
4,643 |
Net income |
275 |
156 |
4,410 |
8,537 |
Net
income attributable to non-controlling interests |
21 |
30 |
104 |
121 |
Net income
attributable to equity holders of Sanofi |
254 |
126 |
4,306 |
8,416 |
Average number of
shares outstanding (million) |
1,245.6 |
1,252.9 |
1,247.1 |
1,256.9 |
Earnings per share
excluding the exchanged/held-for-exchange Animal Health business
(in euros) |
0.21 |
(0.03) |
3.46 |
3.00 |
IFRS Earnings per
share (in euros) |
0.20 |
0.10 |
3.45 |
6.70 |
(1) Includes the effects of first-time
application of IFRS 15 on revenue recognition, effective January 1,
2018.(2) In 2017, net gain resulting from the divestment of the
Animal Health business presented separately in accordance with IFRS
5, Non current assets held-for-sale and discontinued
operations.
Appendix 4: Reconciliation of Net income attributable to
equity holders of Sanofi to Business net income
€ million |
Q4
2018 |
|
Q4
2017(1) |
|
Change |
Net income
attributable to equity holders of Sanofi |
254 |
|
126 |
|
101.6% |
Amortization of
intangible assets(2) |
634 |
|
442 |
|
|
Impairment of
intangible assets |
426 |
|
262 |
|
|
Fair value
remeasurement of contingent consideration |
- |
|
(15) |
|
|
Expenses arising from
the impact of acquisitions on inventories |
- |
|
(10) |
|
|
Other expenses related
to business combinations |
9 |
|
- |
|
|
Restructuring costs and
similar items |
765 |
|
118 |
|
|
Other gains and losses,
and litigation |
7 |
|
61 |
|
|
Tax effect of the items
listed above(3): |
(503) |
|
(219) |
|
|
Amortization and impairment of intangible assets |
(241) |
|
(242) |
|
|
Fair value remeasurement of contingent consideration |
3 |
|
37 |
|
|
Expenses arising from the impact of acquisitions on
inventories |
- |
|
4 |
|
|
Other expenses related to business combinations |
(2) |
|
- |
|
|
Restructuring costs and similar items |
(220) |
|
82 |
|
|
Other tax effects |
(43) |
|
(100) |
|
|
Other tax items(4) |
(56) |
|
631 |
|
|
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 |
(180) |
|
88 |
|
|
Animal Health items
(5) |
9 |
|
(159) |
|
|
Business net
income |
1,364 |
|
1,325 |
|
2.9% |
IFRS earnings per
share (6) (in euros) |
0.20 |
|
0.10 |
|
|
(1) Includes the effects of first-time application
of IFRS 15 on revenue recognition, effective January 1,
2018.(2) Of which related to amortization expense generated
by the remeasurement of intangible assets as part of business
combinations: €520 million in the fourth quarter of 2018 and
€407 million in the fourth quarter of 2017.(3) In 2017, this
line includes the impact of changes in corporate income tax rates,
mainly in France (25% standard rate effective as of January 1,
2022).(4) In 2018, adjustments made to our preliminary
analysis of the direct and indirect impacts of US tax reform. In
2017, includes an amount of €562m related to litigation gain on
French 3% tax on dividends and temporary exceptional surcharge and
an amount of (€1,193) million related to US tax reform.(5) In
2017, net gain resulting from the divestment of the Animal Health
business presented separately in accordance with IFRS 5,
Non-current assets held-for-sale and discontinued operations
(including the closing in Mexico in Q4 2017).(6) Based on an
average number of shares outstanding of 1,245.6 million in the
fourth quarter of 2018 and 1,252.9 million in the fourth quarter of
2017.
€ million |
2018 |
|
2017(1) |
|
Change |
Net income
attributable to equity holders of Sanofi |
4,306 |
|
8,416 |
|
(48.8)% |
Amortization of
intangible assets(2) |
2,170 |
|
1,866 |
|
|
Impairment of
intangible assets |
718 |
|
293 |
|
|
Fair value
remeasurement of contingent consideration |
(117) |
|
159 |
|
|
Expenses arising from
the impact of acquisitions on inventories |
114 |
|
166 |
|
|
Other expenses related
to business combinations |
28 |
|
- |
|
|
Restructuring costs and
similar items |
1,480 |
|
731 |
|
|
Other gains and losses,
and litigation (3) |
(502) |
|
215 |
|
|
Tax effect of the items
listed above(4): |
(1,125) |
|
(1,127) |
|
|
Amortization and impairment of intangible assets |
(692) |
|
(719) |
|
|
Fair value remeasurement of contingent consideration |
38 |
|
4 |
|
|
Expenses arising from the impact of acquisitions on
inventories |
(27) |
|
(52) |
|
|
Other expenses related to business combinations |
(6) |
|
- |
|
|
Restructuring costs and similar items |
(435) |
|
(134) |
|
|
Other tax effects |
(3) |
|
(226) |
|
|
Other tax items(5) |
(188) |
|
742 |
|
|
Share of items listed
above attributable to non-controlling interests |
(2) |
|
(4) |
|
|
Restructuring costs of
associates and joint ventures, and expenses arising from the impact
of acquisitions on associates and joint ventures |
(76) |
|
129 |
|
|
Animal Health items
(6) |
13 |
|
(4,643) |
|
|
Business net
income |
6,819 |
|
6,943 |
|
(1.8)% |
IFRS earnings per
share (7) (in euros) |
3.45 |
|
6.70 |
|
|
(1) Includes the effects of first-time application
of IFRS 15 on revenue recognition, effective January 1,
2018.(2) Of which related to amortization expense generated
by the remeasurement of intangible assets as part of business
combinations: €1,957 million in 2018 and €1,726 million in
2017.(3) In 2018, of which gain resulting from the European
Generics business divestiture amounting to €510 million. In 2017,
mainly adjustment to vendor's guarantee provision in connection
with past divestment.(4) In 2017, this line includes the
impact of changes in corporate income tax rates, mainly in France
(25% standard rate effective as of January 1, 2022). (5) In
2018, adjustments made to our preliminary analysis of the direct
and indirect impacts of US tax reform. In 2017, includes French 3%
tax on dividends and temporary exceptional surcharge for an amount
of €451 million and US tax reform amounting to €(1,193) million.
(6) In 2017, net gain resulting from the divestment of the
Animal Health business presented separately in accordance with IFRS
5, Non-current assets held-for-sale and discontinued
operations.(7) Based on an average number of shares
outstanding of 1,247.1 million in 2018 and 1,256.9 million in
2017.
Appendix 5: Change in net debt
€ million |
2018 |
2017(1) |
|
|
|
Business net
income |
6,819 |
6,943 |
Depreciation,
amortization and impairment of property, plant and equipment and
software |
1,208 |
1,349 |
Gains and losses on
disposals of non-current assets, net of tax |
(284) |
(127) |
Other non cash
items |
91 |
728 |
Operating cash flow
before changes in working capital (2) |
7,834 |
8,893 |
Changes in working
capital (2) |
(1,099) |
(589) |
Acquisitions of
property, plant and equipment and software |
(1,674) |
(1,500) |
Free cash
flow (2) |
5,061 |
6,804 |
Acquisitions of
intangible assets excluding software |
(312) |
(398) |
Acquisitions of
investments in consolidated undertakings including assumed
debt |
(13,051) |
(1,063) |
Restructuring costs and
similar items paid |
(894) |
(754) |
Proceeds from disposals
of property, plant and equipment, intangible assets and other
non-current assets net of tax |
2,120 |
408 |
Issuance of Sanofi
shares |
177 |
319 |
Dividends paid to
shareholders of Sanofi |
(3,773) |
(3,710) |
Acquisition of treasury
shares |
(1,104) |
(2,158) |
Transactions with
non-controlling interests including dividends |
(91) |
(52) |
Foreign exchange
impact |
(288) |
434 |
Net cash-flow from the
swap between BI - CHC and Sanofi Animal Health business |
(6) |
3,535 |
Other items |
(306) |
(292) |
Change in net
debt |
(12,467) |
3,073 |
(1) Includes the effects
of first-time application of IFRS 15 on revenue recognition,
effective January 1, 2018. |
(2) Excluding
restructuring costs and similar items. |
Appendix 6: Simplified consolidated balance sheet
ASSETS€
million |
Dec
31,2018 |
Dec
31,2017(1) |
|
LIABILITIES &
EQUITY€ million |
Dec
31,2018 |
Dec
31,2017(1) |
|
|
|
|
Equity attributable to
equity holders of Sanofi |
58,876 |
58,070 |
|
|
|
|
Equity attributable to
non-controlling interests |
159 |
169 |
|
|
|
|
Total
equity |
59,035 |
58,239 |
|
|
|
|
Long-term debt |
22,007 |
14,326 |
Property, plant and
equipment |
9,651 |
9,579 |
|
Non-current liabilities
related to business combinations and to non-controlling
interests |
963 |
1,026 |
Intangible assets
(including goodwill) |
66,124 |
53,344 |
|
Provisions and other
non-current liabilities |
8,613 |
9,154 |
Non-current financial
assets & investments in associates and deferred tax assets |
10,986 |
10,502 |
|
Deferred tax
liabilities |
3,414 |
1,605 |
Non-current
assets |
86,761 |
73,425 |
|
Non-current
liabilities |
34,997 |
26,111 |
|
|
|
|
Accounts payable &
Other current liabilities |
14,402 |
13,845 |
Inventories, accounts
receivable and other current assets |
17,654 |
16,039 |
|
Current liabilities
related to business combinations and to non-controlling
interests |
341 |
343 |
Cash and cash
equivalents |
6,925 |
10,315 |
|
Short-term debt and
current portion of long-term debt |
2,633 |
1,275 |
Current
assets |
24,579 |
26,354 |
|
Current
liabilities |
17,376 |
15,463 |
Assets held for sale or
exchange |
68 |
34 |
|
Liabilities related to
assets held for sale or exchange |
- |
- |
Total
ASSETS |
111,408 |
99,813 |
|
Total
LIABILITIES & EQUITY |
111,408 |
99,813 |
(1) Includes the effects of first-time
application of IFRS 15 on revenue recognition, effective January 1,
2018.
Appendix 7 : 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 Q4 2018 sales
Currency |
Q4
2018 |
US
$ |
36.6% |
Euro
€ |
23.8% |
Chinese Yuan |
6.2% |
Japanese Yen |
4.7% |
Brazilian Real |
2.7% |
British Pound |
1.8% |
Mexican Peso |
1.8% |
Canadian $ |
1.8% |
Russian Ruble |
1.7% |
Australian $ |
1.4% |
Others |
17.5% |
Currency average rates
|
Q4
2017 |
Q4
2018 |
Change |
€/$ |
1.18 |
1.14 |
-3.1% |
€/Yen |
133.0 |
128.82 |
-3.1% |
€/Yuan |
7.79 |
7.90 |
+1.4% |
€/Real |
3.83 |
4.35 |
+13.6% |
€/Ruble |
68.80 |
75.91 |
+10.3% |
Appendix 8: R&D Pipeline
O : Opt-in rights products for which rights have not
been exercised yetR : Registrational Study (other than
Phase 3)
|
Immuno-inflammation |
|
Rare
Blood Disorders |
|
Cardiovascular & metabolism |
|
Oncology |
|
MS
& Neuro |
|
Vaccines |
|
Rare
Diseases |
|
Diabetes |
|
|
New Molecular Entities(*)
Phase 1 (Total : 17) |
Phase 2 (Total : 7) |
Phase 3 (Total : 7) |
Registration (Total : 2) |
SAR441344Anti-CD40L mAbMultiple Sclerosis |
BIVV001(4) rFVIIIFc - vWF - XTEN(5) Hemophilia A |
SAR440340(**)Anti-IL33 mAbAtopic Dermatitis |
HIV Viral vector prime & rgp120 boost vaccine |
isatuximab Anti-CD38 mAb3L Relapsing Refractory MM
(ICARIA) |
cemiplimab(**)PD-1 inhibitor mAbAdvanced CSCC (EU) |
SAR408701 Maytansin-loaded anti-CEACAM5 mAb
Solid Tumors |
ST400(6) ZFN Gene Editing Technology Beta thalassemia |
SAR156597 IL4/IL13 bispecific mAb
Systemic Scleroderma |
SP0232(**)(13) Respiratory syncytial virusMonoclonal
Antibody |
avalglucosidase alfaNeo GAA Pompe Disease |
ZynquistaTM(**) Oral SGLT-1&2 inhibitor Type 1 Diabetes
(U.S./EU) |
SAR439459 anti-TGFb
mAbAdvanced Solid Tumors |
BIVV003(6) ZFN Gene Editing Technology Sickle
Cell Disease |
R |
olipudase alfa rhASM Acid Sphingomyelinase
Deficiency(10) |
|
venglustatOral GCS inhibitorADPKD(14) |
|
|
O |
REGN5458(1)Anti-BCMA-CD3 bispecific mAbRRMM |
SAR442168(7)(**)BTK inhibitor Multiple
Sclerosis |
SAR339375(11)miRNA-21Alport
Syndrome |
|
fitusiran RNAi therapeutic targeting
anti-thrombin Hemophilia A and B |
|
|
O |
REGN4018(1) Anti-MUC16-CD3 bispecific mAbOvarian
Cancer |
SAR443060(8) RIPK1 inh(9)Amyotrophic
Lateral Sclerosis |
SAR422459(**)(12) ABCA4 gene therapy
Stargardt Disease |
|
sutimlimab(15)Anti Complement C1s mAb Cold
Agglutinin Disease |
|
|
SAR439859 SERDMetastatic Breast Cancer |
Next Gen PCV Pneumococcal Conjugate Vaccines |
|
|
SAR341402 Rapid acting insulin Type 1/2 Diabetes |
|
SAR442720(2) SHP2 inhibitorSolid Tumors |
Herpes Simplex Virus Type 2 HSV-2 vaccine |
|
|
efpeglenatide(**) Long-acting GLP-1 agonist Type 2
Diabetes |
|
SAR440234 T cell engaging multi spe
mAbLeukemia |
Respiratory syncytial virus Infants Vaccines |
|
|
|
|
SAR441000(3) Cytokine mRNAMelanoma |
|
|
|
|
|
|
|
|
|
|
|
Regeneron product for
which Sanofi has opt-in rights Developed in collaboration with
REVOLUTION Medicines; also known as RMC-4630 Developed in
collaboration with BioNtech Sanofi Product for which Sobi has
opt-in rights Recombinant Coagulation Factor VIII Fc - von
Willebrand Factor - XTEN Fusion protein Developed in collaboration
with Sangamo Also known as PRN2246 Also known as DNL747
Receptor-interacting serine/threonine-protein kinase 1 |
Also known as Niemann Pick
type B Regulus product for which Sanofi has decided to opt-in
Identification of out-licensing partner ongoing Also known as
MEDI8897 Autosomal Dominant Polycystic Kidney Disease Also Known as
BIVV009 (*) 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 |
Additional Indications(*)
Phase 1 (Total : 5) |
Phase 2 (Total : 17) |
Phase 3 (Total : 23) |
Registration (Total : 3) |
SAR439459 + cemiplimab(**) Anti-TGFb mAb + PD-1
inhibitor mAbAdvanced Solid Tumors |
dupilumab(**) Anti-IL4Ralpha mAb Grass
Immunotherapy |
isatuximab + atezolizumab(**) Anti-CD38 mAb + PD-L1
inhibitor mAbAdvanced Malignancies |
dupilumab(**) Anti-IL4Ralpha mAb Asthma 6 - 11 years
old |
isatuximabAnti-CD38 mAbNewly Diagnosed MM Te(6) (GMMG) |
dupilumab(**) Anti-IL4Ralpha mAb Asthma 12y+ (EU) |
O |
cemiplimab(**) + REGN4018(1)PD-1 inhibitor mAb +
Anti-MUC16-CD3 bispecific mAb - Ovarian Cancer |
R |
sarilumab(**) Anti-IL6R mAb Polyarticular
Juvenile Idiopathic Arthritis |
isatuximab + atezolizumab(**) Anti-CD38 mAb +
PD-L1 inhibitor mAbSolid Tumors |
dupilumab(**) Anti-IL4Ralpha mAb Nasal
Polyposis |
isatuximab Anti-CD38 mAb1-3L Relapsing
Refractory MM (IKEMA) |
Dupixent®(**)dupilumab Atopic Dermatitis 12 - 17
years old (U.S./EU) |
|
|
SAR439859SERD + PalbociclibMetastatic Breast
Cancer |
sarilumab(**) Anti-IL6R mAb Systemic
Juvenile Arthritis |
venglustatOral GCS inhibitorFabry Disease |
dupilumab(**) Anti-IL4Ralpha mAb Eosinophilic
Esophagitis |
Aubagio® teriflunomide Relapsing Multiple Sclerosis -
Pediatric |
Praluent®(**)alirocumabCV events reduction
(U.S./EU) |
sutimlimab(2) Anti Complement C1s mAb Idiopathic
Thrombocytopenic Purpura |
SAR440340(**) Anti-IL33 mAb COPD |
venglustatOral GCS inhibitorGaucher Type 3 |
Dupixent®(**) dupilumab Atopic Dermatitis 6 - 11 years
old |
Lemtrada® alemtuzumab Relapsing Remitting Multiple
Sclerosis - Pediatric |
|
SAR443060(3) RIPK1 inh(4)Alzheimer's
Disease |
dupilumab(**) + AR101 Anti-IL4Ralpha mAb Peanut
Allergy - Pediatric |
venglustatOral GCS inhibitorGaucher related Parkinson's
Disease |
Dupixent®(**) dupilumab Atopic Dermatitis 6 months -
5 years old |
ZynquistaTM(**)Oral SGLT-1&2 inhibitorWorsening Heart
Failure in Diabetes |
|
|
SAR440340(**) Anti-IL33 mAb Asthma |
Rabies VRVg Purified vero rabies vaccine |
sarilumab(**) Anti-IL6R mAb Giant Cell
Arteritis |
ZynquistaTM(**) Oral SGLT-1&2 inhibitor Type 2
Diabetes |
|
|
R |
cemiplimab(**)PD-1 inhibitor mAbAdvanced Basal
Cell Carcinoma |
SP0173 Tdap booster US Tdap booster |
sarilumab(**) Anti-IL6R mAb Polymyalgia
Rheumatica |
Cerdelga®eliglustatGaucher Type 1, switch from
ERT - Pediatric |
|
|
|
isatuximab + cemiplimab(**) Anti-CD38 mAb + PD-1
inhibitor mAbRelapsing Refractory MM |
|
cemiplimab(**)PD-1 inhibitor mAb1L NSCLC |
Praluent®(**)alirocumabLDL-C reduction - Pediatric |
|
|
isatuximab + cemiplimab(**) Anti-CD38 mAb + PD-1
inhibitor mAbAdvanced Malignancies |
|
cemiplimab(**)+ chemotherapyPD-1 inhibitor mAb1L NSCLC |
Fluzone® QIV HD Quadrivalent inactivated
Influenza vaccine - High dose |
|
|
isatuximab + cemiplimab(**) Anti-CD38 mAb + PD-1
inhibitor mAbLymphoma |
|
cemiplimab(**)PD-1 inhibitor mAb2L Cervical Cancer |
Men
Quad TT Advanced generation meningococcal ACYW conjugate
vaccine |
|
|
|
|
isatuximab Anti-CD38 mAb1L Newly Diagnosed MM Ti(5)
(IMROZ) |
Pediatric pentavalent vaccine DTP-Polio-Hib Japan |
|
|
|
|
|
Shan 6 DTP-HepB-Polio-HibPediatric hexavalent
vaccine |
|
Regeneron product for
which Sanofi has opt-in rights Also known as BIVV009 Also known as
DNL747 Receptor-interacting serine/threonine-protein kinase 1
Transplant ineligible Transplant eligible (*) 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 |
Expected Submission Timeline(1)
|
New Molecular Entities |
Additional Indications |
|
|
|
|
|
2019(2) |
isatuximab anti-CD38 mAb3L RRMM (ICARIA) |
|
dupilumab(**) Anti-IL4Ra mAb Nasal Polyposis
Adult |
Pentacel® vIPVDTaP-IPV/Hib |
SAR341402Rapid acting insulinType 1/2 Diabetes - EU(3) |
|
Fluzone® QIV HD Quadrivalent inactivated
Influenza vaccine - High dose |
Men Quad TT Adv. generation meningococcal U.S.: 2y+ &
EU: Toddlers+ |
|
|
|
|
|
|
|
|
|
2020(2) |
olipudase alfa rhASM ASD(4) |
fitusiran RNAi therapeutic targeting anti-thrombinHemophilia
A/B |
sarilumab(**) Anti-IL6R mAbPolyarticular Juvenile Idiopathic
Arthritis |
isatuximabAnti-CD38 mAb1-3L RRMM (IKEMA) |
avalglucosidase alfaNeoGAAPompe Disease
|
sutimlimab(5)Anti Complement C1s mAb Cold Agglutinin
Disease |
Dupixent®(**) dupilumab AD 6 - 11 years old |
ZynquistaTM(**) Oral SGLT-1&2 inhibitor Type 2
Diabetes |
|
|
cemiplimab(**) PD-1 inhibitor mAbAdvanced BCC |
Aubagio® teriflunomide Relapsing MS - Pediatric |
|
|
|
|
Shan 6 DTP-HepB-Polio-HibPediatric hexavalent vaccine |
|
|
|
|
|
2021(2) |
efpeglenatide(**)Long acting GLP1-R agonistType 2
Diabetes |
|
isatuximabAnti-CD38 mAb1L Newly Diagnosed MM Ti (IMROZ) |
ZynquistaTM(**)Oral SGLT 1/2 inhibitorWorsening Heart
Failure in Diabetes |
|
venglustatOral GCS inhibitorADPKD(6) |
|
cemiplimab(**) PD-1 inhibitor mAb2L Cervical Cancer |
|
|
|
|
cemiplimab(**) PD-1 inhibitor mAb1L NSCLC |
|
|
New Molecular Entities |
Additional Indications |
2022(2) |
SP0232 mAbs(7)(**) Respiratory Syncytial Virus |
|
Dupixent®(**) dupilumab AD 6 months - 5 years
old |
sarilumab(**) Anti-IL6R mAb Systemic Juvenile Arthritis |
|
|
dupilumab(**) Anti-IL4Ra mAb Eosinophilic Esophagitis |
sarilumab(**) Anti-IL6R mAb Polymyalgia
Rheumatica |
|
|
dupilumab(**) Anti-IL4Ralpha mAb Asthma 6 - 11 years
old |
Cerdelga®eliglustatGaucher Type 1, switch from ERT
Pediatric |
|
|
sarilumab(**) Anti-IL6R mAb Giant Cell Arteritis |
venglustatOral GCS inhibitorGaucher Type 3 |
|
|
SP0173 Tdap booster US Tdap booster |
Praluent®(**)alirocumabLDL-C reduction - Pediatric |
|
|
|
|
|
2023and beyond(2) |
SAR440340(**)Anti-IL33 mAbAtopic Dermatitis
|
SAR156597 IL4/IL13 bispecific mAb Systemic
Scleroderma |
SAR440340(**) Anti-IL33 mAb COPD |
dupilumab(**) + AR101 Anti-IL4Ralpha mAb Peanut Allergy -
Pediatric |
SAR422459(**) ABCA4 gene therapy Stargardt Disease |
HIV Viral vector prime & rgp120 boost vaccine |
SAR440340(**)Anti-IL33 mAbAsthma |
venglustatOral GCS inhibitorFabry Disease |
|
|
isatuximabAnti-CD38 mAbNewly Diagnosed MM Te (GMMG) |
Rabies VRVg Purified vero rabies vaccine |
|
|
venglustatOral GCS inhibitorGrPD(8) |
Pediatric pentavalent vaccine DTP-Polio-Hib (Japan) |
- Excluding Phase 1
- Projects within a specified year are not arranged by submission
timing
- Submission strategy for the U.S. under evaluation
- Acid Sphingomyelinase Deficiency
- Also known as BIVV009
- Autosomal Dominant Polycystic Kidney Disease
- Also known as MEDI8897
- 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 Q3
2018
|
Additions |
Removals |
Registration |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phase 3 |
Shan 6 DTP-HepB-Polio-HibPediatric
hexavalent vaccine |
|
mavacamten(**)Myosin inhibitorObstructive
Hypertrophic Cardiomyopathy |
cemiplimab(**)+ ipilimumab PD-1 inh. mAb
+ CTLA4 mAb 1L NSCLC >= 50% PDL1+ |
|
|
|
|
|
|
|
|
|
|
Phase 2 |
SAR440340(**)Anti-IL33 mAbAtopic Dermatitis |
isatuximab + atezolizumab(**) Anti-CD38 mAb + PD-L1
inhibitor mAbSolid Tumors |
GZ389988TRKA antagonistOsteoarthritis |
SAR425899GLP-1/GCG dual
agonistObesity/Overweight in T2D |
|
isatuximab + cemiplimab(**) Anti-CD38 mAb + PD-1
inhibitor mAbLymphoma |
|
Combination ferroquine / OZ439(**)
Antimalarial |
SAR407899 rho kinase Microvascular Angina |
|
|
|
ALX0171Anti RSV NanobodyRespiratory Syncitial
Virus |
mavacamten(**)Myosin inhibitorNon -Obstructive
Hypertrophic Cardiomyopathy |
|
|
|
|
|
Phase 1 |
SAR441344Anti-CD40L mAbMultiple
Sclerosis |
SAR443060 RIPK1 inhAmyotrophic
Lateral Sclerosis |
SAR439794(**)TLR4
agonistPeanut Allergy |
O |
REGN3767Anti-LAG-3 mAbAdvanced Cancers |
|
|
O |
REGN5458Anti-BCMA-CD3 bispecific mAbRRMM |
SAR443060 RIPK1 inhAlzheimer's
Disease |
SAR440181(**) Myosin
activation Dilated Cardiomyopathy |
O |
REGN4659 Anti-CTLA-4 mAbCancer |
|
|
|
SAR441000 Cytokine mRNAMelanoma |
BIVV003 ZFN Gene Editing Technology Sickle Cell Disease |
SAR247799S1P1 agonistCardiovascular
indication |
SAR228810(**) Anti-protofibrillar AB mAb
Alzheimer's Disease |
|
|
Next Gen PCV Pneumococcal Conjugate Vaccines |
SAR438335GLP-1/GIP dual agonistType 2
Diabetes |
UshStat®(**)(1) Myosin 7A gene therapy Usher
Syndrome 1B |
|
|
|
O |
cemiplimab(**) + REGN3767PD-1 inhibitor mAb +
Anti-LAG-3 mAbAdvanced Cancers |
O |
cemiplimab(**) + REGN4659PD-1 inhibitor mAb +
Anti-CTLA-4 mAbNSCLC |
|
|
(**) Partnered and/or in collaboration -
Sanofi may have limited or shared rights on some of these
products
Appendix 9: Expected R&D milestones
Products |
Expected
milestones |
Timing |
Dupixent® |
U.S. regulatory
decision in Atopic Dermatitis in Adolescent patients |
Q1
2019 |
ZynquistaTM
(sotagliflozin) |
U.S. regulatory
decision expected in Type 1 Diabetes |
Q1
2019 |
dupilumab |
U.S. sBLA filing in
Nasal Polyposis |
Q1
2019 |
Dupixent® |
EU regulatory decision
in Asthma in Adult/Adolescent patients |
Q2
2019 |
ZynquistaTM
(sotagliflozin) |
EU regulatory decision
expected in Type 1 Diabetes |
Q2
2019 |
Praluent® |
EU regulatory decision
in CV events reduction ODYSSEY OUTCOMES |
Q2
2019 |
Praluent® |
U.S. regulatory
decision in CV events reduction ODYSSEY OUTCOMES |
Q2
2019 |
cemiplimab |
EU regulatory decision
expected in Advanced Cutaneous Squamous Cell Carcinoma |
Q2
2019 |
dupilumab |
Start of Phase 2b/3
trial in Chronic Obstructive Pulmonary Disease |
H1
2019 |
Dupixent® |
EU regulatory decision
in Atopic Dermatitis in Adolescent patients |
Q3
2019 |
sutimlimab |
Expected pivotal trial
read-outs in Cold Agglutinin Disease |
Q4
2019 |
ZynquistaTM
(sotagliflozin) |
Expected pivotal trial
read-out in Type 2 Diabetes |
Q4
2019 |
Dupixent® |
Expected pivotal trial
read-out in Atopic Dermatitis in 6-11 years |
Q4
2019 |
Olipudase |
Expected pivotal trial
read-out in Niemann Pick Type B |
Q4
2019 |
Isatuximab |
Expected pivotal trial
read-out in 1-3L RRMM (IKEMA) |
Q1
2020 |
Appendix 10: 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 fourth quarter and full-year 2018
€ million |
Q4
2018 |
2018 |
Net sales |
8,997 |
34,463 |
Effect of exchange rates |
(33) |
(1,492) |
Company sales at constant exchange rates |
9,030 |
35,955 |
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)),
- 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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