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.
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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 |
Emerging
Markets |
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 |
Emerging
Markets |
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 yet
R : 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) |
SAR441344
Anti-CD40L mAb
Multiple Sclerosis |
BIVV001(4)
rFVIIIFc - vWF - XTEN(5)
Hemophilia A |
SAR440340(**)
Anti-IL33 mAb
Atopic Dermatitis |
HIV
Viral vector prime & rgp120 boost vaccine |
isatuximab Anti-CD38 mAb
3L Relapsing Refractory MM (ICARIA) |
cemiplimab(**)
PD-1 inhibitor mAb
Advanced 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 virus
Monoclonal Antibody |
avalglucosidase
alfa
Neo GAA
Pompe Disease |
ZynquistaTM(**)
Oral SGLT-1&2 inhibitor
Type 1 Diabetes (U.S./EU) |
SAR439459 anti-TGFb
mAb
Advanced Solid Tumors |
BIVV003(6) ZFN Gene Editing Technology
Sickle Cell Disease |
R
|
olipudase
alfa rhASM
Acid Sphingomyelinase Deficiency(10) |
|
venglustat
Oral GCS inhibitor
ADPKD(14) |
|
|
O
|
REGN5458(1)
Anti-BCMA-CD3 bispecific mAb
RRMM |
SAR442168(7)(**)
BTK inhibitor
Multiple Sclerosis |
SAR339375(11)
miRNA-21
Alport Syndrome |
|
fitusiran RNAi therapeutic targeting anti-thrombin
Hemophilia A and B |
|
|
O
|
REGN4018(1)
Anti-MUC16-CD3 bispecific mAb
Ovarian 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 SERD
Metastatic Breast Cancer |
Next Gen PCV Pneumococcal Conjugate
Vaccines |
|
|
SAR341402 Rapid acting insulin
Type 1/2 Diabetes |
|
SAR442720(2) SHP2 inhibitor
Solid Tumors |
Herpes Simplex Virus Type
2 HSV-2 vaccine |
|
|
efpeglenatide(**)
Long-acting GLP-1 agonist
Type 2 Diabetes |
|
SAR440234 T cell engaging multi spe mAb
Leukemia |
Respiratory syncytial
virus Infants
Vaccines |
|
|
|
|
SAR441000(3)
Cytokine mRNA
Melanoma |
|
|
|
|
|
|
|
|
|
|
|
-
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 mAb
Advanced Solid Tumors |
dupilumab(**) Anti-IL4Ralpha mAb
Grass Immunotherapy |
isatuximab +
atezolizumab(**) Anti-CD38 mAb + PD-L1 inhibitor mAb
Advanced Malignancies |
dupilumab(**) Anti-IL4Ralpha mAb
Asthma 6 - 11 years old |
isatuximab
Anti-CD38 mAb
Newly 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 mAb
Solid Tumors |
dupilumab(**) Anti-IL4Ralpha mAb
Nasal Polyposis |
isatuximab Anti-CD38 mAb
1-3L Relapsing Refractory MM (IKEMA) |
Dupixent®(**)
dupilumab
Atopic Dermatitis 12 - 17 years old (U.S./EU) |
|
|
SAR439859
SERD + Palbociclib
Metastatic Breast Cancer |
sarilumab(**)
Anti-IL6R mAb
Systemic Juvenile Arthritis |
venglustat
Oral GCS inhibitor
Fabry Disease |
dupilumab(**) Anti-IL4Ralpha mAb
Eosinophilic Esophagitis |
Aubagio® teriflunomide
Relapsing Multiple Sclerosis - Pediatric |
Praluent®(**)
alirocumab
CV events reduction (U.S./EU) |
sutimlimab(2) Anti Complement C1s mAb
Idiopathic Thrombocytopenic Purpura |
SAR440340(**) Anti-IL33 mAb
COPD |
venglustat
Oral GCS inhibitor
Gaucher 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 |
venglustat
Oral GCS inhibitor
Gaucher related Parkinson's Disease |
Dupixent®(**)
dupilumab
Atopic Dermatitis 6 months - 5 years old |
ZynquistaTM(**)
Oral SGLT-1&2 inhibitor
Worsening 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 mAb
Advanced Basal Cell Carcinoma |
SP0173 Tdap booster
US Tdap booster |
sarilumab(**)
Anti-IL6R mAb
Polymyalgia Rheumatica |
Cerdelga®
eliglustat
Gaucher Type 1, switch from ERT - Pediatric |
|
|
|
isatuximab +
cemiplimab(**) Anti-CD38 mAb + PD-1 inhibitor mAb
Relapsing Refractory MM |
|
cemiplimab(**)
PD-1 inhibitor mAb
1L NSCLC |
Praluent®(**)
alirocumab
LDL-C reduction - Pediatric |
|
|
isatuximab +
cemiplimab(**) Anti-CD38 mAb + PD-1 inhibitor mAb
Advanced Malignancies |
|
cemiplimab(**)+
chemotherapy
PD-1 inhibitor mAb
1L NSCLC |
Fluzone® QIV HD Quadrivalent
inactivated
Influenza vaccine - High dose |
|
|
isatuximab +
cemiplimab(**) Anti-CD38 mAb + PD-1 inhibitor mAb
Lymphoma |
|
cemiplimab(**)
PD-1 inhibitor mAb
2L Cervical Cancer |
Men Quad TT Advanced generation meningococcal
ACYW conjugate vaccine |
|
|
|
|
isatuximab Anti-CD38 mAb
1L Newly Diagnosed MM Ti(5)
(IMROZ) |
Pediatric pentavalent
vaccine DTP-Polio-Hib
Japan |
|
|
|
|
|
Shan 6
DTP-HepB-Polio-Hib
Pediatric 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 mAb
3L RRMM (ICARIA) |
|
dupilumab(**)
Anti-IL4Ra mAb
Nasal Polyposis Adult |
Pentacel®
vIPV
DTaP-IPV/Hib |
SAR341402
Rapid acting insulin
Type 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-thrombin
Hemophilia A/B |
sarilumab(**)
Anti-IL6R mAb
Polyarticular Juvenile Idiopathic Arthritis |
isatuximab
Anti-CD38 mAb
1-3L RRMM (IKEMA) |
avalglucosidase alfa
NeoGAA
Pompe 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 mAb
Advanced BCC |
Aubagio® teriflunomide
Relapsing MS - Pediatric |
|
|
|
|
Shan 6
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine |
|
|
|
|
|
2021(2)
|
efpeglenatide(**)
Long acting GLP1-R agonist
Type 2 Diabetes |
|
isatuximab
Anti-CD38 mAb
1L Newly Diagnosed MM Ti (IMROZ) |
ZynquistaTM(**)
Oral SGLT 1/2 inhibitor
Worsening Heart Failure in Diabetes |
|
venglustat
Oral GCS inhibitor
ADPKD(6) |
|
cemiplimab(**)
PD-1 inhibitor mAb
2L Cervical Cancer |
|
|
|
|
cemiplimab(**)
PD-1 inhibitor mAb
1L 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®
eliglustat
Gaucher Type 1, switch from ERT
Pediatric |
|
|
sarilumab(**)
Anti-IL6R mAb
Giant Cell Arteritis |
venglustat
Oral GCS inhibitor
Gaucher Type 3 |
|
|
SP0173 Tdap booster US Tdap
booster |
Praluent®(**)
alirocumab
LDL-C reduction - Pediatric |
|
|
|
|
|
2023
and beyond(2) |
SAR440340(**)
Anti-IL33 mAb
Atopic 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 mAb
Asthma |
venglustat
Oral GCS inhibitor
Fabry Disease |
|
|
isatuximab
Anti-CD38 mAb
Newly Diagnosed MM Te (GMMG) |
Rabies VRVg
Purified vero rabies vaccine |
|
|
venglustat
Oral GCS inhibitor
GrPD(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-Hib
Pediatric hexavalent vaccine |
|
mavacamten(**)
Myosin inhibitor
Obstructive Hypertrophic Cardiomyopathy |
cemiplimab(**)+ ipilimumab
PD-1 inh. mAb + CTLA4 mAb
1L NSCLC >= 50% PDL1+ |
|
|
|
|
|
|
|
|
|
|
Phase 2 |
SAR440340(**)
Anti-IL33 mAb
Atopic Dermatitis |
isatuximab +
atezolizumab(**) Anti-CD38 mAb + PD-L1 inhibitor mAb
Solid Tumors |
GZ389988
TRKA antagonist
Osteoarthritis |
SAR425899
GLP-1/GCG dual agonist
Obesity/Overweight in T2D |
|
isatuximab +
cemiplimab(**) Anti-CD38 mAb + PD-1 inhibitor mAb
Lymphoma |
|
Combination
ferroquine / OZ439(**) Antimalarial |
SAR407899 rho
kinase
Microvascular Angina |
|
|
|
ALX0171
Anti RSV Nanobody
Respiratory Syncitial Virus |
mavacamten(**)
Myosin inhibitor
Non -Obstructive Hypertrophic Cardiomyopathy |
|
|
|
|
|
Phase 1 |
SAR441344
Anti-CD40L mAb
Multiple Sclerosis |
SAR443060
RIPK1 inh
Amyotrophic Lateral Sclerosis |
SAR439794(**)
TLR4 agonist
Peanut Allergy |
O
|
REGN3767
Anti-LAG-3 mAb
Advanced Cancers |
|
|
O
|
REGN5458
Anti-BCMA-CD3 bispecific mAb
RRMM |
SAR443060
RIPK1 inh
Alzheimer's Disease |
SAR440181(**) Myosin activation
Dilated Cardiomyopathy |
O
|
REGN4659
Anti-CTLA-4 mAb
Cancer |
|
|
|
SAR441000 Cytokine mRNA
Melanoma |
BIVV003
ZFN Gene Editing Technology
Sickle Cell Disease |
SAR247799
S1P1 agonist
Cardiovascular indication |
SAR228810(**) Anti-protofibrillar AB mAb
Alzheimer's Disease |
|
|
Next Gen PCV Pneumococcal Conjugate
Vaccines |
SAR438335
GLP-1/GIP dual agonist
Type 2 Diabetes |
UshStat®(**)(1)
Myosin 7A gene therapy
Usher Syndrome 1B |
|
|
|
O
|
cemiplimab(**) +
REGN3767
PD-1 inhibitor mAb + Anti-LAG-3 mAb
Advanced Cancers |
O
|
cemiplimab(**) +
REGN4659
PD-1 inhibitor mAb + Anti-CTLA-4 mAb
NSCLC |
|
|
(**) 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.
Q4 2018 Results
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Sanofi via Globenewswire
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