Sanofi : Strong Q3 performance drives guidance upgrade to around
14% business EPS growth at CER(1)
Paris, October 28, 2021
Strong Q3 performance drives guidance
upgrade to around 14% business EPS growth at
CER(1)
Q3 2021 sales grew double digit to €10.4 billion (up
10.1%) due to strong growth from
Dupixent®, Vaccines and
CHC
- Specialty Care sales
increased 20.2% with strong contribution from Dupixent® (+54.6% to
€1,410 million)
- Vaccines up 16.5%,
with record quarterly sales driven by differentiated flu vaccines
and meningitis franchise recovery
- CHC increased 11.1%
driven by growth of Pain care and Digestive Wellness
categories
- General Medicines
sales down 1.7% while transformation of business model supports
core assets growth (up 4.5%)
Q3 2021 business
EPS(2) growth of
19.1% at CER driven by sales performance and
efficiencies
- Business EPS(2) was
€2.18, up 19.1% on a reported basis
- BOI margin reached
34.1% up 2.2 ppts reflecting improvement in Gross margin and
continued expense management
- IFRS EPS was €1.85
(up 19.4 %)
Progress on Corporate Social Responsibility
strategy
- Carbon neutrality
target accelerated to 2030; a 2050 net zero objective
established
- Sanofi ranked #1 in
the European pharma sector by ESG rating agency Vigeo Eiris (part
of Moody’s ESG Solutions)
Key milestone and regulatory achievements on R&D
transformation
- Positive pivotal
phase 3 readouts for Dupixent® in chronic spontaneous urticaria and
infant atopic dermatitis (6 months to 5 years)
- Nexviazyme®
approvals in U.S. and Japan
- Submissions of
sutimlimab in the U.S. and olipudase alfa in Japan under the
Sakigake pathway
- Acquisition of
Translate Bio completed, first positive clinical data read-out
validating the mRNA platform
Full-year 2021 business EPS guidance revised
upward(1)
-
Sanofi now expects 2021 business EPS(2) to grow around 14% at
CER(3), barring unforeseen major adverse events. Applying average
October 2021 exchange rates, the currency impact on 2021 business
EPS is estimated to be between -3.5% to -4.5%
Sanofi Chief Executive Officer, Paul Hudson,
commented:
“Sanofi has delivered outstanding financial
results in the third quarter. Double-digit sales growth in the
period was driven by the remarkable performance of Dupixent®,
record sales of Vaccines and business momentum in Consumer
Healthcare, all in line with our strategic priorities. As a result
of our sales performance and strong earnings, we have upgraded our
full-year EPS guidance growth to around 14% at CER. In R&D, our
growing pipeline of potentially transformative therapies has
progressed, including the most recent positive readouts for
Dupixent® in Eosinophilic esophagitis and Prurigo nodularis as well
as the U.S. approval and launch of Nexviazyme® in Pompe disease.
With higher R&D investment behind our pipeline assets and the
two targeted bolt-on acquisitions of Translate Bio and Kadmon, we
have further increased our commitment to bring innovative medicines
to patients and drive future growth. Aligned with our contract with
society and leading up to COP 26, we have set ourselves new
ambitious ESG targets to reduce carbon emissions and accelerate our
actions in fighting global climate change.”
|
Q3 2021 |
Change |
Change at CER |
9M 2021 |
Change |
Change at CER |
IFRS net sales
reported |
€10,432m |
+10.1% |
+10.1% |
€27,767m |
+4.2% |
+8.2% |
IFRS net income
reported(4) |
€2,317m |
+18.7% |
_ |
€5,093m |
-54.7% |
— |
IFRS EPS reported |
€1.85 |
+19.4% |
_ |
€4.07 |
-54.6% |
— |
Free cash flow(5) |
€2,202m |
+16.9% |
_ |
€5,555m |
+1.9% |
— |
Business
operating income |
€3,558m |
+17.5% |
+17,3% |
€8,461m |
+9.7% |
+15.0% |
Business net
income(2) |
€2,736m |
+19.0% |
+18.8% |
€6,484m |
+11.4% |
+16.9% |
Business EPS(2) |
€2.18 |
+19.1% |
+19.1% |
€5.18 |
+11.6% |
+17.2% |
Changes in net sales are expressed at constant exchange rates
(CER) unless otherwise indicated (definition in Appendix 7)
(1) Sanofi already raised its full-year 2021
business EPS growth guidance to around 12% at CER on July 29; (2)
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 (definition in Appendix 7).
The consolidated income statement for Q3 2021 is provided in
Appendix 3 and a reconciliation of reported IFRS net income to
business net income is set forth in Appendix 4; (3) 2020 restated
business EPS was €5.86; (4) 9M 2021 IFRS net income reported
reflected capital gain from sales of Regeneron shares in Q2 2020;
(5) Free cash flow is a non-GAAP financial measure (definition in
Appendix 7)
2021 third-quarter and first nine months Sanofi
sales
----------------------------
Unless otherwise indicated, all percentage changes
in sales in this press release are stated at CER1
----------------------------
In the third quarter of 2021, Sanofi sales were
€10,432 million, up 10.1% on a reported basis. Exchange rate
movements had a neutral effect, the negative impact of the U.S.
dollar, Japanese yen and Turkish lira was offset by the increase of
the Chinese Yuan and some other currencies.
In the first nine months Sanofi sales reached
€27,767 million, up 4.2% on a reported basis. Exchange rate
movements had a negative effect of 4.0 percentage points. At CER,
company sales were up 8.2%.
Global Business Units
Third-quarter 2021 operating
income
Third-quarter business operating
income (BOI) increased 17.5% to €3,558 million. At CER,
BOI increased 17.3%. The ratio of BOI to net sales increased 2.2
percentage points to 34.1% (34.0% at CER). In the first nine
months, BOI increased 9.7% to €8,461 million. At CER, BOI increased
15.0%. The ratio of business operating income to net sales
increased 1.6 percentage points to 30.5% (30.8% at CER).
Pharmaceuticals
Third-quarter 2021 Pharmaceutical sales
increased 7.8% to €6,855 million, mainly driven by the Specialty
Care portfolio (up 20.2%) with continued strong performance of
Dupixent® while sales in General Medicines decreased 1.7%. In the
first nine months, Pharmaceuticals sales increased 7.7% to €20,051
million reflecting the strong performance of Specialty Care and
General Medicines core assets.
Specialty Care
Dupixent
Net sales (€ million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
Total Dupixent® |
1,410 |
|
+54.6 |
% |
3,700 |
|
+52.5 |
% |
In the third quarter, Dupixent®
(collaboration with Regeneron) sales increased 54.6% to €1,410
million. In the U.S., Dupixent® sales of €1,061 million (up 47.7%)
were driven by continued strong demand in atopic dermatitis (AD) in
adults, adolescents, and children aged 6 to 11 years, and continued
uptake in asthma and chronic rhinosinusitis with nasal polyposis
(CRSwNP). Dupixent® total prescriptions (TRx) increased 45%
(year-over-year) and new-to-brand prescriptions (NBRx) grew 23%
despite fewer in-person physician visits, which remain slightly
below the pre-COVID level. In Europe, third-quarter Dupixent® sales
grew 78.4% to €173 million reflecting continued growth in AD in key
countries and additional launches in asthma in European markets. In
Japan, sales were €78 million (up 68.8%). In the first nine months,
Dupixent® sales reached €3,700 million, up 52.5%.
Neurology and Immunology
Net sales
(€ million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
Aubagio® |
483 |
|
-3.8 |
% |
1,477 |
|
-1.7 |
% |
Lemtrada® |
20 |
|
-16.7 |
% |
63 |
|
-27.2 |
% |
Kevzara® |
83 |
|
+42.4 |
% |
196 |
|
+15.3 |
% |
Total Neurology and Immunology |
586 |
|
+0.3 |
% |
1,736 |
|
-1.4 |
% |
In the third quarter, Neurology and
Immunology sales remained stable to €586 million,
reflecting strong Kevzara® sales which were offset by lower
Aubagio® sales. In the first nine months, Neurology and Immunology
sales were down 1.4% reflecting decreased sales of Lemtrada® and
Aubagio.
Aubagio® sales decreased 3.8%
in the third quarter to €483 million due to lower sales in the U.S.
reflecting increased competition which was partially offset by
higher sales in Europe and the Rest of the World.
Third-quarter Kevzara® (collaboration with
Regeneron) sales increased 42.4% to €83 million due to an increase
in global demand for IL-6 receptor blockers and the temporary
tocilizumab shortage.
Rare Disease
Net sales (€
million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
Myozyme® / Lumizyme® |
266 |
|
+10.4 |
% |
749 |
|
+8.4 |
% |
Fabrazyme® |
209 |
|
+3.4 |
% |
621 |
|
+5.7 |
% |
Cerezyme® |
159 |
|
+0.6 |
% |
502 |
|
+1.1 |
% |
Aldurazyme® |
57 |
|
+5.5 |
% |
180 |
|
+7.3 |
% |
Cerdelga® |
64 |
|
+5.0 |
% |
187 |
|
+10.9 |
% |
Others Rare Disease |
24 |
|
+4.3 |
% |
69 |
|
+10.8 |
% |
Total Rare Disease |
779 |
|
+5.4 |
% |
2,308 |
|
+6.1 |
% |
In the third quarter, Rare
Disease sales increased 5.4% to €779 million driven by
Pompe franchise performance. In the first nine months, sales of
Rare Disease increased 6.1% reflecting growth across all three
geographic regions.
Third-quarter
Myozyme®/Lumizyme®
sales increased 10.4% to €266 million supported primarily by new
patient accruals across geographic regions.
Third-quarter Fabrazyme® sales
increased 3.4% to €209 million driven by higher demand in Europe
and the Rest of the World region, reflecting new patient accruals
and improved treatment compliance.
Sales of the Gaucher franchise
(Cerezyme® + Cerdelga®) increased 1.8% (to €223 million) in the
third quarter. Over the period, Cerezyme® sales
increased 0.6% to €159 million, reflecting growth in the U.S. and
Rest of World region. In Europe Cerezyme® sales were down 4.8% as
Cerdelga® sales were up 5.0% globally driven by
new patient accruals in Europe.
Oncology
Net sales
(€ million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
Jevtana® |
105 |
|
-20.9 |
% |
345 |
|
-10.9 |
% |
Sarclisa® |
48 |
|
+276.9 |
% |
122 |
|
+605.6 |
% |
Fasturtec® |
37 |
|
-9.5 |
% |
111 |
|
+1.8 |
% |
Libtayo® |
35 |
|
+61.9 |
% |
94 |
|
+95.8 |
% |
Total Oncology |
225 |
|
+8.1 |
% |
672 |
|
+19.3 |
% |
Third-quarter and first-nine months sales of
Oncology increased 8.1% (to €225 million) and
19.3%, respectively, driven by the Sarclisa® and Libtayo® launches
which more than offset the impact of Jevtana® generic competition
in Europe.
Third-quarter Jevtana® sales
decreased 20.9% to €105 million following the entry of generic
competition in certain European markets (down 58.3%) at the end of
March. In the U.S., sales were up 1.6%, where the Jevtana®
composition of matter patent has expired in September 2021.
However, Sanofi has filed patent infringement suits against generic
filers on Jevtana® under Hatch-Waxman in the U.S. District Court
for the District of Delaware asserting three method of use patents,
two of which (US 10,583,110 and US 10, 716,777) expire in October
2030 and the other one (US 8,927,592) expires in April 2031
including 6-month pediatric exclusivities. Sanofi has reached
settlement agreements with some of the defendants and the suit
against the remaining defendants is ongoing. No trial dates has
been scheduled and the remaining defendants have agreed not to
launch any generic cabazitaxel product until the earlier of a
district court decision in favor of the defendants or four months
after the completion of the post-trial briefing. Separately,
Jevtana® has been granted a data exclusivity on
the CARD clinical study results which expires in December 2023.
Third-quarter Sarclisa® sales
were €48 million (versus €13 million in the third quarter of 2020)
driven by additional country launches in Europe (€17 million),
higher sales in the U.S (€18 million) and in the Rest of the world
region (€13 million) driven by the uptake in Japan.
Libtayo® (collaboration with Regeneron) sales
were €35 million (up 61.9%) in the third quarter driven by
increased demand in metastatic cutaneous squamous cell carcinoma
(CSCC) as well as additional country launches. Libtayo® sales in
the U.S. are reported by Regeneron.
Rare Blood Disorders
Net sales (€
million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
Eloctate® |
144 |
|
-4.6 |
% |
422 |
|
-7.3 |
% |
Alprolix® |
101 |
|
-6.4 |
% |
301 |
|
-4.8 |
% |
Cablivi® |
42 |
|
+32.3 |
% |
126 |
|
+56.6 |
% |
Total Rare Blood Disorders |
287 |
|
-1.4 |
% |
849 |
|
-0.4 |
% |
In the third quarter, Rare Blood
Disorders franchise sales decreased 1.4% (€287 million).
Excluding industrial sales to Sobi, third-quarter sales were up
7.1% mainly driven by Cablivi®. Alprolix® and Eloctate® industrial
sales to Sobi are expected to be significantly lower in 2021 than
in 2020 due to a change in the supply agreement. In the first nine
months sales of Rare Blood Disorders decreased 0.4% and were up
9.8.% when excluding industrial sales to Sobi.
Eloctate® sales were €144 million in the third
quarter, down 4.6%. Excluding industrial sales to Sobi, Eloctate
sales were up 2.2% driven by higher U.S. sales (+3.7%) which
benefited from buying patterns in the quarter . Sales in the Rest
of the World were down 25.0% reflecting lower industrial sales to
Sobi (which are recorded in this region).
Third-quarter Alprolix® sales
were down 6.4% to €101 million. Excluding industrial sales to Sobi,
Alprolix® sales were up 6.3% driven by U.S. sales (up 5.0%) which
benefited from buying patterns in the quarter. Sales in the Rest of
the World were down 37.9% reflecting lower industrial sales to Sobi
(which are recorded in this region).
Cablivi® generated sales of €42 million (up
32.3%) in the third quarter driven by launches in Europe (up 120.0%
to €22 million). In the U.S., sales of the product were €19
million, down 9.5% reflecting the impact of the COVID-19
environment on treatment initiations with Cablivi® at the hospital
level.
General Medicines
Third quarter General Medicines sales decreased
1.7% to €3,568 million. The growth of core assets2 (up 4.5% to
€1,437 million and up 5.6% excluding Praluent® U.S. sales) was more
than offset by the non-core assets sales decrease (down 6.3% to
€1,923 million) mainly reflecting lower Lantus® sales in the U.S.,
portfolio streamlining (-1.3 ppt impact) and a decline in
Aprovel®/Avapro® sales. Third-quarter Industrial sales3 were €208
million up 2.5%. Excluding portfolio streamlining, third quarter
General Medicines sales were down 0.7% (- 1.0 ppt impact).
In the first nine months, General Medicines
sales were down 0.6% to €10,786 million. During the same period,
sales of the core assets were €4,339 million up 6.8%, driven by
strong performance of Lovenox®, Toujeo® and Thymoglobulin®.
Non-core assets sales were €5,859 million, down 5.8% reflecting
portfolio streamlining (-2.0 ppt), as well as lower Lantus® and
Aprovel®/Avapro® sales. Over the same period, Industrial sales were
€588 million up 4.2%. Excluding portfolio streamlining, General
Medicines sales were up 0.5 % (-1.1 ppt impact).
Diabetes
Net sales
(€ million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
Lantus® |
622 |
|
-5.9 |
% |
1,911 |
|
-4.1 |
% |
Toujeo® |
239 |
|
+11.1 |
% |
739 |
|
+7.9 |
% |
Total
glargine |
861 |
|
-1.7 |
% |
2,650 |
|
-1.0 |
% |
Soliqua® |
51 |
|
+27.5 |
% |
141 |
|
+28.7 |
% |
Other diabetes |
211 |
|
-6.6 |
% |
653 |
|
-3.7 |
% |
Total Diabetes |
1,123 |
|
-1.7 |
% |
3,444 |
|
-0.6 |
% |
In the third quarter, global
Diabetes sales decreased 1.7% to €1,123 million.
Sales growth in the Rest of the Word (up 9.3%) was more than offset
by lower sales in the U.S. (down 13.4%) and Europe (down 3.2%). In
the first nine months, Diabetes sales were down 0.6% mainly as a
result of lower Lantus® sales partially offset by growth from
Toujeo® and Soliqua®.
Third-quarter Toujeo® sales
increased 11.1% to €239 million reflecting growth across all
geographies and strong growth in the Rest of World region (up
20.0%).
Lantus® sales were €622
million, down 5.9% in the third quarter, reflecting lower sales in
the U.S. and Europe due to a continued decline in average U.S. net
price, increasing use of Toujeo® and biosimilar glargine
competition. In the Rest of World region, Lantus® sales were up
10.1% driven by China.
Third-quarter Soliqua® sales
increased 27.5% to €51 million driven by growth in all three
geographic regions. In the Rest of World region, third-quarter
Soliqua® sales grew 40.0% mainly due to new launches.
Cardiovascular and Established Rx
Products
Net
sales (€ million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
Lovenox®* |
383 |
|
+4.4 |
% |
1,151 |
|
+19.1 |
% |
Plavix®* |
222 |
|
+6.3 |
% |
707 |
|
+1.0 |
% |
Aprovel®/Avapro® |
107 |
|
-21.8 |
% |
307 |
|
-29.4 |
% |
Thymoglobulin® |
91 |
|
+4.6 |
% |
263 |
|
+16.1 |
% |
Multaq® |
79 |
|
0.0 |
% |
230 |
|
+4.3 |
% |
Praluent® |
59 |
|
+18.0 |
% |
163 |
|
-15.8 |
% |
Mozobil® |
60 |
|
+7.1 |
% |
170 |
|
+13.5 |
% |
Generics |
172 |
|
-10.9 |
% |
566 |
|
-0.3 |
% |
Other |
1,064 |
|
-4.0 |
% |
3,197 |
|
-5.0 |
% |
Total Cardiovascular and Established Rx
Products |
2,237 |
|
-2.1 |
% |
6,754 |
|
-1.0 |
% |
*Excluding Auto generics
In the third quarter, Cardiovascular
and Established Rx Products sales
decreased 2.1% to €2,237 million. The performance of the core
assets including Lovenox®, Plavix®, Thymoglobulin®, Mozobil® and
Praluent® was more than offset by lower sales of Aprovel®/Avapro®
and generics as well as the impact of the divestments of non-core
products. In the first nine months, Cardiovascular and Established
Rx Products sales were down 1.0% (up 0.1% excluding Praluent® U.S.
sales) mainly due to lower Aprovel®/Avapro® sales and the
divestments which offset strong growth of several core assets.
Third-quarter Lovenox® sales
increased 4.4% to €383 million, driven by strong sales in Rest of
World region (up 9.5%). COVID-19 related demand continued to be
strong (guidelines recommending the use of low molecular weight
heparins in hospitalized COVID-19 patients). However, growth
performance was impacted by a comparable high base in the third
quarter of 2020, supply limitations and biosimilar competition in
Europe (down 1.8%).
Plavix® sales were up 6.3% in
the third quarter to €222 million due to higher sales in Rest of
World (up 9.2%) driven by China (up 16.7% to €90 million) largely
offsetting lower sales in Japan and Europe.
Third-quarter
Aprovel®/Avapro®
sales were down 21.8% to €107 million reflecting supply
constraints.
Third-quarter Praluent® sales
increased 18.0% to €59 million, reflecting the restructuring of the
collaboration with Regeneron effective April 1, 2020. Sanofi has
sole responsibility for Praluent® outside the U.S. while Regeneron
has sole responsibility for Praluent® in the U.S. Excluding U.S.
sales in the comparable quarter last year, higher Praluent® sales
(up 63.9%) were driven by the launch in China and strong
performance in Europe.
Multaq® third quarter sales
were stable at €79 million, reflecting U.S. sales growth which was
offset by lower sales in Europe.
Pharmaceuticals business operating
income
In the third quarter, business operating
income (BOI) of Pharmaceuticals increased 2.8% to €2,409
million (up 1.7% at CER). The ratio of BOI to net sales decreased
by 1.7 percentage points to 35.1%. At CER, the ratio decreased 2.0
percentage points reflecting Regeneron MAbs alliance and increased
R&D expenses in priority assets and commercial expenses in
Specialty Care growth drivers, despite an improvement of the gross
margin ratio. In the first nine months, business operating income
of Pharmaceuticals decreased 1.2% to €7,320 million (up 3.1% at
CER). The ratio of BOI to net sales decreased by 1.7 percentage
points to 36.5% (36.6% at CER).
Vaccines
Net sales (€
million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
Polio/Pertussis/Hib vaccines (incl.
Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®) |
563 |
|
+1.8 |
% |
1,616 |
|
+3.1 |
% |
Influenza vaccines(incl. Vaxigrip®,
Fluzone HD®, Fluzone® & Flublok®) |
1,339 |
|
+25.5 |
% |
1,535 |
|
+23.9 |
% |
Meningitis/Pneumo vaccines (incl.
Menactra®) |
253 |
|
+18.7 |
% |
567 |
|
+36.2 |
% |
Adult Booster vaccines (incl. Adacel
®) |
158 |
|
+4.6 |
% |
364 |
|
+8.7 |
% |
Travel and other endemic vaccines |
82 |
|
+16.9 |
% |
215 |
|
-1.3 |
% |
Other vaccines |
27 |
|
+8.7 |
% |
62 |
|
+18.5 |
% |
Total Vaccines |
2,422 |
|
+16.5 |
% |
4,359 |
|
+13.8 |
% |
Third-quarter Vaccines sales
grew 16.5% to €2,422 million driven by influenza vaccines
performance and meningitis vaccination recovery in the U.S. In the
first nine months, Vaccines sales grew 13.8% due to the strong
performance of the influenza vaccines franchise and a recovery of
meningitis vaccines more than offsetting the negative COVID-19
impact on the travel vaccines.
In the third quarter,
Polio/Pertussis/Hib (PPH) vaccines sales increased
1.8% to €563 million. In Europe, PPH sales decreased 11.2%
reflecting unfavorable phasing effect and lower birth rates due to
the pandemic. In Rest of World, PPH sales were up 3.5% supported by
Pentaxim® in China and Polio vaccines which
largely offset the impact of lower birth rates. In the U.S., PPH
sales increased 6.8% due to positive inventory fluctuation.
VaxelisTM, the first and only hexavalent
combination vaccine approved in the U.S., was launched in the U.S.
in June 2021. Developed as part of a joint-partnership between
Sanofi and Merck, VaxelisTM in-market sales are not consolidated
and the profits shared equally between the two parties. As Vaxelis™
is expected to partly replace Pentacel® sales, PPH sales in the
U.S. are expected to decrease going forward.
Influenza vaccines sales
increased 25.5% in the third quarter to €1,339 million as a result
of earlier shipments in the U.S and a strong increase in
differentiated influenza vaccines in Europe driven by Germany which
adopted a preferential recommendation for
Efluelda® for people above 60 years old. Influenza
vaccines sales in the U.S and in Europe grew 18.1% (to €982
million) and 87.8% (to €247 million), respectively.
Third-quarter Meningitis sales
were up 18.7% to €253 million mainly with the recovery of
meningitis vaccination in the U.S. and in Middle East in
conjunction with the U.S. launch of MenQuadfi® in
March 2021.
Adult Booster vaccines sales
grew 4.6% in the third quarter to €158 million, due to the gradual
recovery of Adacel® vaccinations in the U.S.
Third-quarter Travel and other endemic
vaccines sales increased 16.9% versus a low 2020
basis.
Vaccines business operating
income
In the third quarter, business operating
income (BOI) increased 29.8% to €1,359 million reflecting
the strong sales growth. At CER, BOI increased 29.5%. The ratio of
BOI to net sales was 56.1% (versus 50.4% in the third quarter of
2020) reflecting a favorable product mix driven by influenza
vaccines and Meningitis vaccines as well as good industrial
performance. In the first nine months, BOI increased 30.7% (up
33.0% at CER) to €1,957 million reflecting strong sales performance
as well as the payment from Daiichi Sankyo in the first quarter of
2021. The ratio of BOI to net sales increased 6.6 percentage points
to 44.9% (44.7% at CER).
Consumer Healthcare
Net sales (€
million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
Allergy |
142 |
|
+17.4 |
% |
485 |
|
+2.2 |
% |
Cough, Cold and Flu |
94 |
|
+4.4 |
% |
204 |
|
-30.9 |
% |
Pain Care |
290 |
|
+18.2 |
% |
818 |
|
+7.3 |
% |
Digestive Wellness |
282 |
|
+16.0 |
% |
855 |
|
+21.8 |
% |
Physical Wellness |
85 |
|
-7.7 |
% |
244 |
|
-5.7 |
% |
Mental Wellness |
53 |
|
+8.2 |
% |
160 |
|
+16.8 |
% |
Personal Care |
135 |
|
+5.4 |
% |
387 |
|
+2.8 |
% |
Non-Core
/ Others |
74 |
|
+4.2 |
% |
204 |
|
-5.8 |
% |
Total Consumer Healthcare |
1,155 |
|
+11.1 |
% |
3,357 |
|
+4.2 |
% |
In the third quarter, Consumer
Healthcare (CHC) sales increased 11.1% to €1,155 million
driven by growth in all three geographic regions and the
performance of the Digestive Wellness category, as well as the Pain
Care category which also benefited from COVID-19 vaccinations. In
the first nine months CHC sales increased 4.2% mainly due to the
growing sales in Digestive Wellness, Pain Care and Mental Wellness
categories which more than offset a weak cough and cold season last
winter and the divestments of non-core products (-0.6 ppt
impact).
In the U.S., third-quarter CHC
sales increased 16.4% to €289 million driven by strong growth of
Pain Care, Personal Care (driven by Gold bond) and Digestive
Wellness categories as well as Allergy which benefited from a low
base for comparison.
In Europe, third-quarter CHC
sales increased 3.1% to €335 million mainly reflecting growth of
Pain Care and Digestive categories which more than offset lower
sales from the Cough, Cold and Flu category due to the impact of
social distancing measures.
In Rest of World, third-quarter
CHC sales increased 13.9% to €531 million, supported by strong
growth of Pain Care and Digestive Wellness categories as well as
higher sales from the Allergy category.
CHC business operating incomeIn
the third quarter, business operating income (BOI)
of CHC increased 44.1% (44.4% at CER) to €464 million reflecting
higher sales and a strict control of operational expenses. The
ratio of BOI to net sales increased 9.3 percentage point to 40.2%
versus the prior year and included a €77 million capital gain
related to divestment of non-strategic assets. In the first nine
months of 2021, BOI of CHC increased 8.0% (up 14.5% at CER) to
€1,195 million. The ratio of BOI to net sales increased 2.7
percentage points to 35.6% (36.1% at CER).
Company sales by geographic
region
Sanofi sales (€
million) |
Q3 2021 |
Change at CER |
9M 2021 |
Change at CER |
United States |
4,477 |
|
+13.4 |
% |
10,565 |
|
+13.4 |
% |
Europe |
2,483 |
|
+8.9 |
% |
6,955 |
|
+5.3 |
% |
Rest of the World |
3,472 |
|
+6.7 |
% |
10,247 |
|
+5.0 |
% |
of which China |
782 |
|
+12.8 |
% |
2,162 |
|
+8.5 |
% |
of which Japan |
423 |
|
+13.3 |
% |
1,253 |
|
+2.1 |
% |
of which Brazil |
198 |
|
+14.8 |
% |
651 |
|
+16.7 |
% |
of which
Russia |
139 |
|
-0.7 |
% |
439 |
|
-3.8 |
% |
Total Sanofi sales |
10,432 |
|
+10.1 |
% |
27,767 |
|
+8.2 |
% |
Third-quarter sales in the U.S.
increased 13.4% to €4,477 million supported by the strong
performance of Dupixent® and double-digit growth of Vaccines and
CHC. In the first nine months, U.S. sales grew 13.4%, mainly
reflecting Dupixent® and Vaccines performance.
In Europe sales increased 8.9%
in the third quarter to €2,483 million mainly driven by strong
Vaccines growth and Dupixent® performance. In the first nine
months, European sales increased 5.3% due to the growth of
Specialty Care products driven by Dupixent® and Vaccines which more
than offset lower sales of General Medicines and CHC.
In Rest of World sales
increased 6.7% to €3,472 million in the third quarter, driven by
the performance of Dupixent®, General medicine and CHC. Sales in
China increased 12.8% to €782 million mainly
sustained by Dupixent®, Vaccines, CHC and General Medicines
performance. In Japan, third-quarter sales
increased 13.3% to €423 million reflecting the strong performance
of Dupixent® and Sarclisa®. In Rest of World first-nine months
sales increased 5.0% mainly supported by growth of Dupixent®,
Oncology, General Medicines and CHC.
R&D update at the end of the third
quarter 2021
Regulatory update
-
The U.S. Food and Drug Administration (FDA)
approved
Nexviazyme® (avalglucosidase
alfa) for the treatment of patients one year of age and older with
late-onset Pompe disease. Nexviazyme® was also
approved in Japan. Nexviazyme® is a long-term
enzyme replacement therapy targeting the mannose-6-phosphate
receptor, the key pathway for cellular uptake of enzyme replacement
therapy, to effectively clear glycogen build-up in muscle cells.
The approval was based on the Phase 3 COMET study, showing
clinically meaningful improvements in respiratory function and
movement endurance measures in people with late-onset Pompe
disease.
-
The European Committee for Medicinal Products for Human Use (CHMP)
has adopted a positive opinion for
Nexviazyme® (avalglucosidase
alfa), for the treatment of Pompe disease.
However, they considered that avalglucosidase alfa does not qualify
as a New Active Substance (NAS), leading Sanofi to be requesting a
re-examination of the CHMP opinion in relation to the NAS
conclusion.
- The FDA
accepted the resubmission of the Biologics License
Application (BLA) for sutimlimab, its
investigational therapy for the treatment of
hemolysis in adult patients with cold
agglutinin disease (CAD). The FDA is reviewing the BLA
under priority review with a PDUFA action date of February 5, 2022.
Sutimlimab has previously received Breakthrough Therapy Designation
(BTD) and Orphan Drug Designations (ODD) from the FDA.
-
Olipudase alfa, an investigational recombinant
human acid sphingomyelinase for the treatment of Acid
Sphingomyelinase Deficiency (ASMD), was
submitted in Japan on September 30th, through the
Sakigake regulatory pathway.
-
The FDA accepted for priority review of
the supplemental Biologics License Application (sBLA) for
PD-1 inhibitor Libtayo®
(cemiplimab) to treat patients in 2L with recurrent or
metastatic cervical cancer.
-
The FDA approved
fexinidazole, the first 10-day
once-a-day oral treatment for Trypanosoma brucei gambiense
sleeping sickness, in patients 6 years of age and
older and weighing at least 20 kg. Both first stage and second
stage of the disease are targeted, in which the parasites have
crossed the blood-brain barrier, causing patients to suffer from
neuropsychiatric symptoms.
-
The China National Medical Products Administrations (NMPA)
approved the use of
Dupixent® (dupilumab), for the
treatment of patients aged 12 years and older with
moderate-to-severe atopic dermatitis whose disease
is not adequately controlled with topical prescription therapies or
when those therapies are not advisable.
-
The FDA granted Fast-Track Designation for
SAR443820, a RIPK1 inhibitor currently in Phase 1,
for the amyotrophic lateral sclerosis (ALS)
indication.
-
The FDA granted ODD for SAR445088
(formerly known as BIVV020), a complement C1s inhibitor currently
in Phase 2, for the treatment of Chronic inflammatory
demyelinating polyneuropathy (CIDP).
Portfolio update
Phase 3:
-
Dupixent® met its primary
and all key secondary endpoints in Study A (the first of
two trials) of the pivotal LIBERTY CUPID clinical program, showing
a nearly doubled reduction in itch and urticaria activity scores,
compared to antihistamines (standard-of-care treatment), in
patients with moderate-to-severe chronic spontaneous
urticaria (CSU). Study B of the clinical trial evaluates
Dupixent® in adults and adolescents who remain symptomatic despite
standard-of-care treatment and are intolerant or incomplete
responders to an anti-IgE therapeutic (omalizumab). This study is
expected to read out in H1 2022. CSU is an inflammatory skin
disease, affecting more than 300,000 patients in the U.S.
alone.
-
The pivotal trial evaluating
Dupixent® (dupilumab) for the
treatment of children aged 6 months to 5 years with
moderate-to-severe atopic dermatitis, met
its primary and all secondary endpoints. The data show
adding Dupixent® to standard of care topical corticosteroids (TCS)
significantly reduced the overall disease severity and improved the
skin clearance, itch and health-related quality of life measures at
16 weeks compared to TCS alone.
-
Detailed data from the MELODY study for nirsevimab
to prevent respiratory illness caused by RSV (Respiratory Syncytial
Virus) in infants was presented at the IDWeek congress showing a
74.5% reduction in medically attended LRTI (Lower
Respiratory Tract Infections) after 5 months of follow up.
-
The study evaluating Libtayo® in
combination with platinum-doublet chemotherapy was stopped
early after meeting its overall survival primary endpoint,
compared to chemotherapy alone, in first-line treatment of patients
with advanced non-small cell lung
cancer (NSCLC), with metastatic or
locally advanced disease and tumors with either squamous or
non-squamous histology and across all PD-L1 expression levels.
Results were presented at the 2021 European Society of Oncology
(ESMO) congress.
-
The PEGASUS phase 3 trial, evaluating
rilzabrutinib, a BTK inhibitor for the treatment
of pemphigus, a rare autoimmune skin condition,
did not meet its primary or key secondary
endpoints. The proportion of patients meeting the primary
endpoint on Rilzabrutinib, was not significantly different from
placebo. Rilzabrutinib continues to be investigated in a Phase 3
trial for the treatment of immune
thrombocytopenia, a rare blood disorder, and in a Phase 2
study for the autoimmune condition IgG4-related
disease. Additional Phase 2 studies in immunological and
rare blood disorders diseases including asthma, atopic
dermatitis, chronic spontaneous urticaria and warm
autoimmune hemolytic anemia are planned to start in
2021.
-
A potential filing date for fitusiran, a small
interference RNA therapy in development for the treatment of people
with hemophilia A or B, with or without inhibitors, has been moved
to 2024 due the introduction of a lower dose cohort in the ongoing
phase 3 studies. The lower dose may be available to those patients
currently on 50 mg every other month with anti-thrombin levels
below the lower threshold of 15% and may enable them to continue to
receive prophylactic treatment with fitusiran.
-
A new phase 3 study evaluating the safety profile of
Nexviazyme® in
infantile-onset Pompe Disease was
initiated in children from 6 months to 17
years.
-
Patient enrollment is ongoing in EU and ROW in the phase 3
multicenter, open-label ELIKIDS study of
Cerdelga® in pediatric patients
with Gaucher Disease Type 1 and Type 3, under the pediatric
investigation plan (PIP) as part of the overall clinical
development plan. Submission is currently planned for 2025. Given
the integral nature of the project it is not detailed anymore on
the overall Sanofi pipeline chart.
-
MenQuadfi®, a quadrivalent
ACWY vaccine, met all primary and
secondary endpoints, demonstrating the induced superior
immune responses to serogroup C based on geometric mean antibody
titers (GMTs) compared to NeisVac-C (monovalent C vaccine) -
standard-of-care vaccine- , in healthy toddlers. The data also
showed superior immune responses to serogroup C based on
seroprotection rates and GMTs compared to Nimenrix® (quadrivalent
ACWY vaccine) in this population. MenQuadfi is approved in Europe
for use as a single dose in individuals 12 months of age and older
for the prevention of invasive meningococcal ACWY disease. In the
US it is licensed for the prevention of invasive meningococcal
disease in individuals 2 years of age and older.
Phase 2
-
Positive results from a Phase 2a study evaluating the safety and
efficacy of amlitelimab in patients with
moderate-to-severe atopic dermatitis, were
presented as a late-breaker at the European Academy of Dermatology
and Venerology (EADV) 2021 Virtual Congress. Amlitelimab, formerly
known as KY1005, is a human monoclonal antibody
targeting immune system regulator OX40-Ligand At
week 16, the data demonstrated that when dosed intravenously every
four weeks an 80% improvement in average EASI from baseline for the
low dose and a 70% improvement in average EASI from baseline for
the high dose was achieved, compared to 49% for the placebo group
indicating a consistent pharmacological effect of
blocking OX40-L. A Phase 2b dose ranging study is about to start,
including lower doses and subcutaneous injection.
-
SAR444727 (formerly known as PRN473), a topically
administered BTK inhibitor, entered Phase 2a
study, evaluating safety, tolerability, and
pharmacokinetics in patients with mild-to-moderate atopic
dermatitis.
-
Data of tolebrutinib, an oral
brain penetrant BTK inhibitor, were published in Lancet Neurology.
The Phase 2b trial showed both safety and efficacy
in relapsing multiple sclerosis. The treatment led
to a dose-dependent reduction in new gadolinium-enhancing lesions,
leading to a reduction of acute inflammation, while the drug was
well tolerated. The phase 3 clinical trials in patients with
relapsing and progressive forms of multiple sclerosis are currently
enrolling.
-
SAR444245 (formerly known as THOR707), a novel
non-alpha IL-2, entered a phase 2 basket trial in
combination with Libtayo® for the treatment of various
advanced skin cancers.
-
A phase 2 study cohort evaluating safety and efficacy of
Sarclisa® in combination with
atezolizumab in 1L mCRC was
terminated.
-
A phase 2 study evaluating the safety and efficacy of
Sarclisa®, in Adults with
Warm Autoimmune Hemolytic Anemia (wAIHA) was
initiated.
-
The phase 1/2 study of SP0254, an mRNA-based
COVID-19 vaccine candidate, delivered positive interim results
confirming the company’s platform robust capabilities and strategy
in mRNA. Taking into account public health needs and given
sufficient mRNA COVID-19 vaccines supply can be expected going
forward, the development of SP0254 will not be further
continued.
Phase 1
-
SAR443216, an anti-CD3xCD28xHER2 trispecific
antibody, entered phase 1 study for the treatment of
metastatic gastric cancers with HER2 low
expression or HER2 mutation.
-
SAR443726, a novel IL13/OX40L nanobody entered a
first-in-human, three-part, randomized, double-blind,
placebo-controlled study to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics in healthy adult
participants and in adult participants with
moderate-to-severe atopic
dermatitis.
-
Sangamo and Sanofi are continuing to advance the zinc finger genome
editing program (SAR445136, formerly known as
BIVV003) for sickle cell disease. The companies recently obtained
manufacturing requirements guidance from FDA in preparation for
further clinical studies and expect to share preliminary data from
the sickle cell program at an upcoming meeting. The parties agreed
to terminate the program addressing transfusion-dependent
β-thalassemia (ST400) while focusing resources on
the sickle cell disease indication.
Acquisitions
-
On September 14, Sanofi completed the acquisition of
Translate Bio, acquiring all of their outstanding
shares for $38.00 per share in cash, representing a total equity
value of approximately $3.2 billion. Translate Bio is a
clinical-stage mRNA therapeutics company, having already signed a
collaboration with Sanofi in 2018, to develop mRNA
vaccines which was further expanded in 2020 to broadly
address current and future infectious diseases. The acquisition
builds on Sanofi’s establishment of a first-of-its kind vaccines
mRNA Center of Excellence.
-
On September 8, Sanofi entered into a definitive
agreement to acquire Kadmon
Holdings4 for $9.50 per share in cash,
which represents a total equity value of approximately $1.9
billion. The acquisition supports Sanofi’s
strategy to continue to grow its General Medicines
core assets and will immediately add
Rezurock™(belumosudil) to its transplant
portfolio. This latter, a Rho-associated coiled-coil
kinase 2 (ROCK2) inhibitor, has been recently FDA-approved,
first-in-class treatment for chronic graft-versus-host
disease (cGVHD) for adult and pediatric patients 12 years
and older who have failed at least two prior lines of systemic
therapy.
An update of the R&D pipeline as of
September 30, 2021, is available on our website.
Progress on implementation of the
Corporate Social Responsibility strategy
Sanofi is accelerating its efforts to address
climate change and intends to achieve net zero5 greenhouse gas
(GHG) emissions across all operations (scope 1 & 2) and the
entire value chain (scope 3) by 2050. In alignment with the 1.5°C
pathway, this new commitment will be building on years of work to
reduce the environmental footprint of its products and activities
through its Planet Mobilization program.
In this journey, the company has also set an
interim target to reach by 2030 carbon neutrality6 across all
scopes of emissions, 20 years ahead of its previous commitment made
in 2015 after the COP21 and the Paris Agreement.
Sanofi’s carbon footprint (scope 1 and 2) has
decreased by –27% between 2015 and 2020. As per today, renewable
electricity represents 50% of total electricity consumption, on
track to reach 100% of renewable electricity supply in 2030, and
its RE1007 commitment.
As a result of an eco-driving policy and the
renewal of the car fleet, the eco fleet represents 22% of total car
fleet today with the objective to reach 100% by 2030.
The company will continue to report on progress
annually to ensure its efforts are on track.
Finally, in the run-up to the 26th UN Climate
Change Conference of the Parties (COP26), Sanofi has joined the
UN’s 'Race to Zero' initiative. This global campaign mobilizes
cities, regions, investors and 20% of the major companies by
revenue committing to net zero carbon emissions by 2050. The COP26
will take place in Glasgow (UK) from October 31 until November 12,
2021.
In recognition of Sanofi’ ESG strategy
implementation, Sanofi is ranked #1 in the European pharmaceutical
sector in the latest international ESG ranking issued by Vigeo
Eiris (V.E), published late August 2021. V.E, which is part of
Moody’s ESG Solutions, is an independent international ESG rating
agency. Its assessment is based on information covering 28 areas of
interest ranging from climate change, health, safety, and
environmental issues to human and labor rights.
VE's ESG scores measure the degree to which
companies factor and manage material Environmental, Social and
Governance factors. Across the pharmaceutical sector globally,
Sanofi scored of 62/100 points moving up from its fourth place in
the ranking one year ago.
Embedded in Sanofi's long-term Play to Win
strategy, the company’s ESG strategy is based on four essential
pillars.
Sanofi Global Health, a newly formed nonprofit
unit within the company, will provide thirty of Sanofi's medicines
across a wide range of therapeutic areas to patients in 40 of the
lowest income countries. Sanofi Global Health will also fund the
training of healthcare professionals and the development of
sustainable care systems.
Sanofi continues its efforts to fight polio and
sleeping sickness, two of its historical programs that address
global health issues. Sanofi is the only pharmaceutical company
that keeps developing and supplying treatments for sleeping
sickness. It has committed itself alongside the WHO to eliminate
this neglected tropical disease in humans by 2030. Over the years,
Sanofi has supplied billions of polio vaccine doses, including
hundreds of millions of donated doses to support the global polio
eradication effort.
To contribute to better resource conservation,
Sanofi plans to remove all pre-formed plastic packaging (blister
packs) for its vaccines by 2027. In addition, the company is
committed to ecodesigning all its new products by 2025. To reduce
its greenhouse gas emissions by 55% by 2030, all Sanofi sites will
use 100% renewable electricity and the company has set a target of
a carbon-neutral car fleet, both by 2030.
As a global company, Sanofi is committed to
ensuring that its leaders reflect the communities and patients it
serves. The company is committed to continue fostering an
organization where all employees have equal opportunities to reach
positions of responsibility within the company.
Sanofi also keeps its commitment to making a
strong contribution to current global public health priorities,
with the supply of half a billion doses of authorized vaccines.
Sanofi is the only company leveraging its worldwide manufacturing
capacity and expertise for the supply of three different authorized
COVID-19 vaccines from BioNTech / Pfizer, Moderna, and Johnson
& Johnson. Manufacturing teams on three industrial sites of the
company in France, Germany and the U.S. are mobilized, with 30
million doses released by end September.
At the same time, Sanofi continues its efforts
in the fight against the COVID-19 pandemic with its adjuvanted
recombinant protein candidate vaccine, developed in partnership
with GSK. In parallel to its ongoing Phase 3 efficacy and safety
study, Sanofi has expanded its development program to include a
study of the vaccine as a potentially broadly protective booster to
address evolving public health needs. First data readout is
expected before year-end.
2021 third-quarter and the first nine months financial
results
Business Net
Income8
In the third quarter of 2021, Sanofi generated
net sales of €10,432 million, an increase of 10.1%
(on a reported basis and at CER). In the first nine months, net
sales were €27,767 million up 4.2% (up 8.2% at CER).
Third-quarter other revenues
decreased 0.7% (up 0.2% at CER) to €397 million, reflecting
decreased VaxServe sales of non-Sanofi products (€336 million, down
5.3% at CER). In the first nine months, other revenues increased
2.0% (up 8.1% at CER) to €993 million, including higher VaxServe
sales of non-Sanofi products (€790 million, up 0.8% at CER).
Third-quarter Gross Profit
increased 13.0% (on a reported basis and at CER) to €7,591 million.
The gross margin ratio increased 1.9 percentage points to 72.8%
versus the third quarter of 2020. This improvement mainly reflected
efficiency gains in Industrial Affairs, favorable impact of growing
weight of Specialty Care (the Pharmaceuticals gross margin ratio
improved from 73.5% to 75.2%), positive product mix of Vaccines
(Vaccines gross margin ratio increased 3.7 percentage point to
72.0% which more than offset lower CHC gross margin ratio (64.7%
versus 66.6%). In the first nine months, the gross margin ratio
increased 0.9 percentage point to 72.0% (72.1% at CER).
Research and Development
(R&D) expenses increased 9.2% (up 9.3% at CER) to €1,443
million in the third quarter, reflecting increase in priority
assets development and early pipeline as well as recent
acquisitions partly offset by efficiencies. In the first nine
months, R&D expenses increased 2.3% to €4,106 million and were
up 4.9% at CER as increased investment behind key assets were
partly offset by the benefits of terminating diabetes and
cardiovascular care related projects recorded in 2020.
Third-quarter selling general and
administrative expenses (SG&A) increased 3.9% to
€2,267 million. At CER, SG&A expenses were up 3.6%, reflecting
increased commercial investments in Specialty Care growth drivers
which were partially offset by continued streamlining of General
and Administrative expenses (G&A). In the third quarter, the
ratio of SG&A to sales decreased 1.3 percentage points to 21.7%
compared to the prior year. In the first nine months, SG&A
expenses increased 0.1% to €6,797 million (up 3.6% at CER). In the
first nine months, ratio of SG&A to sales was 1.0 percentage
point lower at 24.5% compared to the prior year.
Third-quarter operating
expenses were €3,710 million, an increase of 5.9% and 5.7%
at CER. In the first nine months operating expenses were €10,903
million, an increase of 0.9% and an increase of 4.1% at CER.
Third-quarter other current operating
income net of expenses was -€289 million versus -€182
million in the third quarter of 2020. Other current operating
income net of expenses included an expense of €399 million (versus
an expense of €229 million in the third quarter of 2020)
corresponding to the share of profit to Regeneron of the monoclonal
antibodies Alliance, reimbursement of development costs by
Regeneron and the reimbursement of commercialization-related
expenses incurred by Regeneron. In the first nine months, other
current operating income net of expenses was -€589 million versus
-€437 million in the same period of 2020.
The share of profit from
associates was -€5 million versus €1 million in Q3 2020
and included the share of U.S profit related to VaxelisTM.
Third-quarter business operating
income8 (BOI) increased 17.5% to €3,558 million. At CER,
BOI increased 17.3%. The ratio of BOI to net sales was 34.1% versus
31.9% in Q3 2020 reflecting seasonal contribution of flu vaccines,
gross margin ratio improvement as well as SG&A ratio
improvement. In the first nine months, business operating income
was €8,461 million, up 9.7% (up 15.0% at CER) and the ratio of
business operating income to net sales increased 1.6 percentage
points to 30.5% (30.8% at CER).
Net financial expenses were €85
million in the third quarter versus €76 million in the same period
of 2020.
Third-quarter and the first-nine months 2021
effective tax rate was 21.0% versus 22% in the
prior year. Sanofi expects its effective tax rate to be around 21%
in 2021, everything being equal in the U.S.
Third-quarter business net
income8 increased 19.0% to €2,736 million and increased
18.8% at CER. The ratio of business net income to net sales
increased 1.9 percentages points to 26.2% versus the third quarter
of 2020. In the first nine months, business net income increased
11.4% to €6,484 million and increased 16.9% at CER. The ratio of
business net income to net sales increased 1.6 percentage points to
23.4% versus the same period of 2020.
In the third quarter of 2021, business
earnings per share8 (EPS) was €2.18, up
19.1% on a reported basis (and at CER). The average number of
shares outstanding was 1,254.5 million versus 1,255.7 million in
third quarter 2020. In the first nine months of 2021, business
earnings per share8 was €5.18, up 11.6% on a reported basis and up
17.2% at CER. The average number of shares outstanding was 1,251.7
million in the first nine months of 2021 versus 1,253.0 million in
the first nine months 2020.
Reconciliation of IFRS net income
reported to business net income (see Appendix 4)
In the first nine months of 2021, the IFRS net
income was €5,093 million. The main items excluded from the
business net income were:
- An amortization
charge of €1,160 million related to fair value remeasurement on
intangible assets of acquired companies (primarily Genzyme: €380
million, Bioverativ: €238 million, Boehringer Ingelheim CHC
business: €148 million and Ablynx: €126 million) and to acquired
intangible assets (licenses/products: €70 million). These items
have no cash impact on the Company.
- An impairment of
intangible assets of €177 million mainly related to sutimlimab
(termination of ITP).
- Restructuring costs
and similar items of €494 million related to streamlining
initiatives.
- A €440 million tax
effect arising from the items listed above, mainly comprising €320
million of deferred taxes generated by amortization and impairments
of intangible assets and €121 million associated with restructuring
costs and similar items (see Appendix 4).
Capital Allocation
In the first nine months of 2021, free cash flow
before restructuring, acquisitions and disposals increased by 21.0%
to €6,968 million, after net changes in working capital (+€218
million) and capital expenditures (-€953 million). After
acquisitions9 (-€1,093 million of which Kiadis -€319 million, Tidal
Therapeutics -€135 millions), proceeds from disposals9 (+€461
million), and payments related to restructuring and similar items
(-€781 million), free cash flow10 increased 1.9% to €5,555 million,
reflecting recent acquisitions to strengthen the long-term pipeline
and less proceeds compared to last year as Seprafilm was divested
in Q1 2020 (€311 million). After the acquisition of Translate Bio
(-€ 2,397 million) and Kymab (-€922 million) and the dividend paid
by Sanofi (-€4,008 million), net debt increased from €8,790 million
at December 31, 2020 to €10,427 million at September 30, 2021
(amount net of €9,785 million 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, risks related to Sanofi’s ability to complete
the proposed transaction with Kadmon Holdings, Inc. on the proposed
terms or on the proposed timeline, including the receipt of
required regulatory approvals, the possibility that competing
offers will be made, other risks associated with executing business
combination transactions, as well as other risks related to
Sanofi’s business, including the ability to grow sales and revenues
from existing products and to develop, commercialize or market new
products, competition, 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 fact that product candidates if
approved may not 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 and market conditions, cost
containment initiatives and subsequent changes thereto, and the
impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on
any of the foregoing could also adversely impact us. This situation
is changing rapidly and additional impacts may arise of which we
are not currently aware and may exacerbate other previously
identified risks. The risks and uncertainties also include the
uncertainties 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, 2020. 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: |
2021 third-quarter
and first nine months sales by GBU, franchise, geographic region
and product |
Appendix 2: |
2021 third-quarter
and first nine months business net income statement |
Appendix 3: |
2021 third-quarter
and first nine months consolidated income statement |
Appendix 4: |
Reconciliation of
IFRS net income reported to business net income |
Appendix 5: |
Change in net debt |
Appendix 6: |
Currency
sensitivity |
Appendix 7: |
Definitions of
non-GAAP financial indicators |
Investor Relations: (+) 33 1 53 77 45 45 -
E-mail: IR@sanofi.com - Media
Relations: (+) 33 1 53 77 46 46 -
E-mail: MR@sanofi.comWebsite: www.sanofi.com |
Appendix 1: 2021 third-quarter net sales
by GBU, franchise, geographic region and product
Q3 2021
(€ million) |
Total Sales |
% CER |
% reported |
|
United States |
% CER |
|
Europe |
% CER |
|
Rest of the world |
% CER |
Dupixent |
1,410 |
54.6 |
% |
53.6 |
% |
|
1,061 |
47.7 |
% |
|
173 |
78.4 |
% |
|
176 |
82.3 |
% |
Aubagio |
483 |
-3.8 |
% |
-4.4 |
% |
|
328 |
-6.8 |
% |
|
122 |
1.7 |
% |
|
33 |
10.0 |
% |
Lemtrada |
20 |
-16.7 |
% |
-16.7 |
% |
|
9 |
-35.7 |
% |
|
7 |
-14.3 |
% |
|
4 |
66.7 |
% |
Kevzara |
83 |
42.4 |
% |
40.7 |
% |
|
49 |
75.0 |
% |
|
24 |
33.3 |
% |
|
10 |
-15.4 |
% |
Neurology & Immunology |
586 |
0.3 |
% |
-0.3 |
% |
|
386 |
-2.0 |
% |
|
153 |
4.8 |
% |
|
47 |
6.5 |
% |
Cerezyme |
159 |
0.6 |
% |
-1.9 |
% |
|
45 |
4.7 |
% |
|
59 |
-4.8 |
% |
|
55 |
3.5 |
% |
Cerdelga |
64 |
5.0 |
% |
6.7 |
% |
|
33 |
0.0 |
% |
|
26 |
13.0 |
% |
|
5 |
0.0 |
% |
Myozyme |
266 |
10.4 |
% |
10.4 |
% |
|
103 |
13.2 |
% |
|
105 |
6.1 |
% |
|
58 |
13.5 |
% |
Fabrazyme |
209 |
3.4 |
% |
2.5 |
% |
|
101 |
0.0 |
% |
|
53 |
3.9 |
% |
|
55 |
9.8 |
% |
Aldurazyme |
57 |
5.5 |
% |
3.6 |
% |
|
13 |
7.7 |
% |
|
20 |
0.0 |
% |
|
24 |
9.1 |
% |
Rare Disease |
779 |
5.4 |
% |
4.6 |
% |
|
296 |
5.7 |
% |
|
264 |
3.5 |
% |
|
219 |
7.2 |
% |
Jevtana |
105 |
-20.9 |
% |
-21.6 |
% |
|
63 |
1.6 |
% |
|
20 |
-58.3 |
% |
|
22 |
-4.3 |
% |
Fasturtec |
37 |
-9.5 |
% |
-11.9 |
% |
|
22 |
-17.9 |
% |
|
12 |
9.1 |
% |
|
3 |
0.0 |
% |
Libtayo |
35 |
61.9 |
% |
66.7 |
% |
|
— |
0.0 |
% |
|
28 |
47.4 |
% |
|
7 |
200.0 |
% |
Sarclisa |
48 |
276.9 |
% |
269.2 |
% |
|
18 |
111.1 |
% |
|
17 |
750.0 |
% |
|
13 |
550.0 |
% |
Oncology |
225 |
8.1 |
% |
7.1 |
% |
|
103 |
6.0 |
% |
|
77 |
-3.8 |
% |
|
45 |
46.7 |
% |
Alprolix |
101 |
-6.4 |
% |
-7.3 |
% |
|
83 |
5.0 |
% |
|
— |
0.0 |
% |
|
18 |
-37.9 |
% |
Eloctate |
144 |
-4.6 |
% |
-5.3 |
% |
|
111 |
3.7 |
% |
|
— |
0.0 |
% |
|
33 |
-25.0 |
% |
Cablivi |
42 |
32.3 |
% |
35.5 |
% |
|
19 |
-9.5 |
% |
|
22 |
120.0 |
% |
|
1 |
0.0 |
% |
Rare Blood Disorder |
287 |
-1.4 |
% |
-1.7 |
% |
|
213 |
2.9 |
% |
|
22 |
120.0 |
% |
|
52 |
-30.1 |
% |
Specialty Care |
3,287 |
20.2 |
% |
19.4 |
% |
|
2,059 |
21.4 |
% |
|
689 |
17.2 |
% |
|
539 |
19.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Lantus |
622 |
-5.9 |
% |
-5.3 |
% |
|
199 |
-20.9 |
% |
|
113 |
-11.1 |
% |
|
310 |
10.1 |
% |
Toujeo |
239 |
11.1 |
% |
10.6 |
% |
|
72 |
9.1 |
% |
|
96 |
6.7 |
% |
|
71 |
20.0 |
% |
Soliqua/iGlarLixi |
51 |
27.5 |
% |
27.5 |
% |
|
30 |
25.0 |
% |
|
7 |
16.7 |
% |
|
14 |
40.0 |
% |
0thers Diabetes |
211 |
-6.6 |
% |
-7.0 |
% |
|
39 |
-23.1 |
% |
|
61 |
-3.2 |
% |
|
111 |
-0.9 |
% |
Diabetes |
1,123 |
-1.7 |
% |
-1.5 |
% |
|
340 |
-13.4 |
% |
|
277 |
-3.2 |
% |
|
506 |
9.3 |
% |
Lovenox |
383 |
4.4 |
% |
4.9 |
% |
|
9 |
14.3 |
% |
|
166 |
-1.8 |
% |
|
208 |
9.5 |
% |
Plavix |
222 |
6.3 |
% |
8.3 |
% |
|
2 |
-33.3 |
% |
|
28 |
-6.9 |
% |
|
192 |
9.2 |
% |
Multaq |
79 |
0.0 |
% |
0.0 |
% |
|
70 |
1.4 |
% |
|
5 |
-16.7 |
% |
|
4 |
0.0 |
% |
Praluent |
59 |
18.0 |
% |
18.0 |
% |
|
— |
-100.0 |
% |
|
41 |
36.7 |
% |
|
18 |
200.0 |
% |
Aprovel |
107 |
-21.8 |
% |
-19.5 |
% |
|
4 |
-42.9 |
% |
|
19 |
-13.0 |
% |
|
84 |
-22.3 |
% |
Mozobil |
60 |
7.1 |
% |
7.1 |
% |
|
33 |
3.1 |
% |
|
16 |
7.1 |
% |
|
11 |
20.0 |
% |
Thymoglobulin |
91 |
4.6 |
% |
4.6 |
% |
|
52 |
1.9 |
% |
|
9 |
0.0 |
% |
|
30 |
11.5 |
% |
Generics |
172 |
-10.9 |
% |
-10.9 |
% |
|
26 |
-40.5 |
% |
|
3 |
0.0 |
% |
|
143 |
-2.7 |
% |
Others |
1,064 |
-4.0 |
% |
-2.9 |
% |
|
96 |
-10.2 |
% |
|
335 |
-9.2 |
% |
|
633 |
0.2 |
% |
Cardiovascular & Established Rx Products |
2,237 |
-2.1 |
% |
-1.2 |
% |
|
292 |
-12.5 |
% |
|
622 |
-4.8 |
% |
|
1,323 |
2.0 |
% |
Industrial Sales |
208 |
2.5 |
% |
2.0 |
% |
|
9 |
-60.0 |
% |
|
186 |
13.4 |
% |
|
13 |
-25.0 |
% |
General Medicines |
3,568 |
-1.7 |
% |
-1.1 |
% |
|
641 |
-14.3 |
% |
|
1,085 |
-1.6 |
% |
|
1,842 |
3.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals |
6,855 |
7.8 |
% |
7.8 |
% |
|
2,700 |
10.5 |
% |
|
1,774 |
4.9 |
% |
|
2,381 |
6.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
563 |
1.8 |
% |
1.8 |
% |
|
124 |
6.8 |
% |
|
79 |
-11.2 |
% |
|
360 |
3.5 |
% |
Adult Booster Vaccines |
158 |
4.6 |
% |
4.6 |
% |
|
105 |
14.1 |
% |
|
36 |
-7.7 |
% |
|
17 |
-15.0 |
% |
Meningitis / Pneumonia |
253 |
18.7 |
% |
18.2 |
% |
|
218 |
19.7 |
% |
|
— |
0.0 |
% |
|
35 |
12.9 |
% |
Influenza Vaccines |
1,339 |
25.5 |
% |
25.7 |
% |
|
982 |
18.1 |
% |
|
247 |
87.8 |
% |
|
110 |
5.9 |
% |
Travel and Other Endemic Vaccines |
82 |
16.9 |
% |
15.5 |
% |
|
34 |
100.0 |
% |
|
12 |
200.0 |
% |
|
36 |
-26.0 |
% |
Vaccines |
2,422 |
16.5 |
% |
16.6 |
% |
|
1,488 |
18.5 |
% |
|
374 |
41.8 |
% |
|
560 |
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy |
142 |
17.4 |
% |
17.4 |
% |
|
92 |
13.6 |
% |
|
8 |
-11.1 |
% |
|
42 |
35.5 |
% |
Cough, Cold and Flu |
94 |
4.4 |
% |
4.4 |
% |
|
— |
0.0 |
% |
|
45 |
-10.2 |
% |
|
49 |
22.0 |
% |
Pain Care |
290 |
18.2 |
% |
17.4 |
% |
|
53 |
23.3 |
% |
|
127 |
9.5 |
% |
|
110 |
27.3 |
% |
Digestive Wellness |
282 |
16.0 |
% |
16.0 |
% |
|
29 |
16.0 |
% |
|
97 |
9.0 |
% |
|
156 |
20.9 |
% |
Physical Wellness |
85 |
-7.7 |
% |
-6.6 |
% |
|
— |
0.0 |
% |
|
7 |
0.0 |
% |
|
78 |
-8.3 |
% |
Mental Wellness |
53 |
8.2 |
% |
8.2 |
% |
|
11 |
0.0 |
% |
|
23 |
4.3 |
% |
|
19 |
20.0 |
% |
Personal Care |
135 |
5.4 |
% |
4.7 |
% |
|
101 |
9.7 |
% |
|
1 |
0.0 |
% |
|
33 |
-8.3 |
% |
Non-Core / Others |
74 |
4.2 |
% |
4.2 |
% |
|
3 |
-233.3 |
% |
|
27 |
-16.1 |
% |
|
44 |
2.3 |
% |
Consumer Healthcare |
1,155 |
11.1 |
% |
11.0 |
% |
|
289 |
16.4 |
% |
|
335 |
3.1 |
% |
|
531 |
13.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
10,432 |
10.1 |
% |
10.1 |
% |
|
4,477 |
13.4 |
% |
|
2,483 |
8.9 |
% |
|
3,472 |
6.7 |
% |
Appendix 1: 2021 first nine months net
sales by GBU, franchise, geographic region and product
First 9M
2021 (€ million) |
Total Sales |
% CER |
% reported |
|
United States |
% CER |
|
Europe |
% CER |
|
Rest of the world |
% CER |
Dupixent |
3,700 |
52.5 |
% |
45.0 |
% |
|
2,801 |
46.3 |
% |
|
462 |
70.1 |
% |
|
437 |
85.0 |
% |
Aubagio |
1,477 |
-1.7 |
% |
-6.1 |
% |
|
994 |
-6.2 |
% |
|
386 |
10.0 |
% |
|
97 |
8.7 |
% |
Lemtrada |
63 |
-27.2 |
% |
-31.5 |
% |
|
29 |
-36.7 |
% |
|
18 |
-32.0 |
% |
|
16 |
5.6 |
% |
Kevzara |
196 |
15.3 |
% |
11.4 |
% |
|
99 |
13.0 |
% |
|
65 |
18.2 |
% |
|
32 |
17.2 |
% |
Neurology & Immunology |
1,736 |
-1.4 |
% |
-5.7 |
% |
|
1,122 |
-6.0 |
% |
|
469 |
8.6 |
% |
|
145 |
10.1 |
% |
Cerezyme |
502 |
1.1 |
% |
-5.3 |
% |
|
128 |
2.3 |
% |
|
183 |
-2.1 |
% |
|
191 |
3.3 |
% |
Cerdelga |
187 |
10.9 |
% |
6.9 |
% |
|
97 |
7.2 |
% |
|
77 |
13.2 |
% |
|
13 |
30.0 |
% |
Myozyme |
749 |
8.4 |
% |
5.0 |
% |
|
283 |
11.5 |
% |
|
305 |
4.5 |
% |
|
161 |
10.5 |
% |
Fabrazyme |
621 |
5.7 |
% |
0.6 |
% |
|
291 |
0.6 |
% |
|
164 |
10.1 |
% |
|
166 |
11.3 |
% |
Aldurazyme |
180 |
7.3 |
% |
1.7 |
% |
|
39 |
7.7 |
% |
|
63 |
6.8 |
% |
|
78 |
7.6 |
% |
Rare Disease |
2,308 |
6.1 |
% |
1.4 |
% |
|
839 |
5.6 |
% |
|
794 |
5.2 |
% |
|
675 |
8.0 |
% |
Jevtana |
345 |
-10.9 |
% |
-14.8 |
% |
|
182 |
4.3 |
% |
|
95 |
-32.1 |
% |
|
68 |
-8.9 |
% |
Fasturtec |
111 |
1.8 |
% |
-2.6 |
% |
|
65 |
-4.1 |
% |
|
34 |
9.7 |
% |
|
12 |
20.0 |
% |
Libtayo |
94 |
95.8 |
% |
95.8 |
% |
|
— |
0.0 |
% |
|
76 |
76.7 |
% |
|
18 |
260.0 |
% |
Sarclisa |
122 |
605.6 |
% |
577.8 |
% |
|
46 |
250.0 |
% |
|
44 |
2100.0 |
% |
|
32 |
1600.0 |
% |
Oncology |
672 |
19.3 |
% |
14.9 |
% |
|
293 |
14.7 |
% |
|
249 |
15.3 |
% |
|
130 |
41.7 |
% |
Alprolix |
301 |
-4.8 |
% |
-10.1 |
% |
|
245 |
8.3 |
% |
|
— |
0.0 |
% |
|
56 |
-38.3 |
% |
Eloctate |
422 |
-7.3 |
% |
-12.4 |
% |
|
327 |
1.8 |
% |
|
— |
0.0 |
% |
|
95 |
-29.3 |
% |
Cablivi |
126 |
56.6 |
% |
51.8 |
% |
|
62 |
22.2 |
% |
|
62 |
113.8 |
% |
|
2 |
0.0 |
% |
Rare Blood Disorder |
849 |
-0.4 |
% |
-5.7 |
% |
|
634 |
6.0 |
% |
|
62 |
113.8 |
% |
|
153 |
-32.1 |
% |
Specialty Care |
9,265 |
19.2 |
% |
13.6 |
% |
|
5,689 |
19.6 |
% |
|
2,036 |
19.5 |
% |
|
1,540 |
17.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Lantus |
1,911 |
-4.1 |
% |
-7.9 |
% |
|
628 |
-7.8 |
% |
|
359 |
-11.8 |
% |
|
924 |
2.1 |
% |
Toujeo |
739 |
7.9 |
% |
3.8 |
% |
|
192 |
-2.4 |
% |
|
291 |
4.7 |
% |
|
256 |
21.3 |
% |
Soliqua/iGlarLixi |
141 |
28.7 |
% |
22.6 |
% |
|
83 |
23.9 |
% |
|
21 |
23.5 |
% |
|
37 |
44.4 |
% |
0thers Diabetes |
653 |
-3.7 |
% |
-7.6 |
% |
|
126 |
-11.2 |
% |
|
191 |
-3.5 |
% |
|
336 |
-0.6 |
% |
Diabetes |
3,444 |
-0.6 |
% |
-4.5 |
% |
|
1,029 |
-5.3 |
% |
|
862 |
-4.2 |
% |
|
1,553 |
5.0 |
% |
Lovenox |
1,151 |
19.1 |
% |
15.7 |
% |
|
24 |
13.6 |
% |
|
534 |
15.0 |
% |
|
593 |
23.1 |
% |
Plavix |
707 |
1.0 |
% |
-0.8 |
% |
|
7 |
0.0 |
% |
|
88 |
-7.4 |
% |
|
612 |
2.3 |
% |
Multaq |
230 |
4.3 |
% |
-1.3 |
% |
|
202 |
4.9 |
% |
|
17 |
-5.6 |
% |
|
11 |
10.0 |
% |
Praluent |
163 |
-15.8 |
% |
-16.8 |
% |
|
5 |
-92.7 |
% |
|
116 |
34.9 |
% |
|
42 |
53.6 |
% |
Aprovel |
307 |
-29.4 |
% |
-30.1 |
% |
|
7 |
-63.2 |
% |
|
66 |
-11.8 |
% |
|
234 |
-31.4 |
% |
Mozobil |
170 |
13.5 |
% |
9.7 |
% |
|
93 |
8.9 |
% |
|
45 |
10.0 |
% |
|
32 |
36.0 |
% |
Thymoglobulin |
263 |
16.1 |
% |
11.4 |
% |
|
153 |
16.4 |
% |
|
25 |
13.6 |
% |
|
85 |
16.2 |
% |
Generics |
566 |
-0.3 |
% |
-7.8 |
% |
|
96 |
-12.8 |
% |
|
7 |
0.0 |
% |
|
463 |
2.7 |
% |
Others |
3,197 |
-5.0 |
% |
-7.6 |
% |
|
254 |
-14.0 |
% |
|
1,032 |
-11.2 |
% |
|
1,911 |
0.1 |
% |
Cardiovascular & Established Rx Products |
6,754 |
-1.0 |
% |
-4.1 |
% |
|
841 |
-10.3 |
% |
|
1,930 |
-2.0 |
% |
|
3,983 |
1.8 |
% |
Industrial Sales |
588 |
4.2 |
% |
2.1 |
% |
|
33 |
-32.7 |
% |
|
521 |
15.8 |
% |
|
34 |
-45.6 |
% |
General Medicines |
10,786 |
-0.6 |
% |
-3.9 |
% |
|
1,903 |
-8.2 |
% |
|
3,313 |
-0.2 |
% |
|
5,570 |
2.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals |
20,051 |
7.7 |
% |
3.5 |
% |
|
7,592 |
11.1 |
% |
|
5,349 |
6.5 |
% |
|
7,110 |
5.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
1,616 |
3.1 |
% |
0.2 |
% |
|
365 |
29.3 |
% |
|
224 |
-10.4 |
% |
|
1,027 |
-1.1 |
% |
Adult Booster Vaccines |
364 |
8.7 |
% |
5.8 |
% |
|
218 |
21.3 |
% |
|
102 |
-9.7 |
% |
|
44 |
2.3 |
% |
Meningitis / Pneumonia |
567 |
36.2 |
% |
30.6 |
% |
|
425 |
43.1 |
% |
|
1 |
0.0 |
% |
|
141 |
18.9 |
% |
Influenza Vaccines |
1,535 |
23.9 |
% |
23.4 |
% |
|
982 |
16.3 |
% |
|
265 |
94.1 |
% |
|
288 |
11.8 |
% |
Travel and Other Endemic Vaccines |
215 |
-1.3 |
% |
-4.4 |
% |
|
70 |
23.3 |
% |
|
25 |
-40.5 |
% |
|
120 |
0.0 |
% |
Vaccines |
4,359 |
13.8 |
% |
11.4 |
% |
|
2,114 |
24.3 |
% |
|
618 |
13.6 |
% |
|
1,627 |
2.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy |
485 |
2.2 |
% |
-3.4 |
% |
|
292 |
5.8 |
% |
|
42 |
-6.7 |
% |
|
151 |
-1.9 |
% |
Cough, Cold and Flu |
204 |
-30.9 |
% |
-32.2 |
% |
|
— |
0.0 |
% |
|
91 |
-42.4 |
% |
|
113 |
-18.2 |
% |
Pain Care |
818 |
7.3 |
% |
2.8 |
% |
|
144 |
8.5 |
% |
|
377 |
5.3 |
% |
|
297 |
9.2 |
% |
Digestive Wellness |
855 |
21.8 |
% |
16.5 |
% |
|
90 |
57.4 |
% |
|
297 |
6.4 |
% |
|
468 |
27.3 |
% |
Physical Wellness |
244 |
-5.7 |
% |
-7.9 |
% |
|
— |
0.0 |
% |
|
20 |
5.3 |
% |
|
224 |
-6.5 |
% |
Mental Wellness |
160 |
16.8 |
% |
11.9 |
% |
|
34 |
5.9 |
% |
|
78 |
15.9 |
% |
|
48 |
27.5 |
% |
Personal Care |
387 |
2.8 |
% |
-3.0 |
% |
|
292 |
3.3 |
% |
|
3 |
50.0 |
% |
|
92 |
0.0 |
% |
Non-Core / Others |
204 |
-5.8 |
% |
-9.3 |
% |
|
7 |
700.0 |
% |
|
80 |
-26.2 |
% |
|
117 |
6.8 |
% |
Consumer Healthcare |
3,357 |
4.2 |
% |
-0.2 |
% |
|
859 |
10.0 |
% |
|
988 |
-4.6 |
% |
|
1,510 |
7.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
27,767 |
8.2 |
% |
4.2 |
% |
|
10,565 |
13.4 |
% |
|
6,955 |
5.3 |
% |
|
10,247 |
5.0 |
% |
Appendix 2: Business net income
statement
Third Quarter 2021 |
Pharmaceuticals |
Vaccines |
Consumer Healthcare |
Other(1) |
Total Group |
€ million |
Q3 2021 |
Q3 2020 |
Change |
Q3 2021 |
Q3 2020 |
Change |
Q3 2021 |
Q3 2020 |
Change |
Q3 2021 |
Q3 2020 |
Change |
Q3 2021 |
Q3 2020 |
Change |
Net sales |
6,855 |
6,361 |
7.8% |
2,422 |
2,077 |
16.6% |
1,155 |
1,041 |
11.0% |
— |
— |
—% |
10,432 |
9,479 |
10.1% |
Other revenues |
44 |
28 |
57.1% |
339 |
359 |
-5.6% |
14 |
13 |
7.7% |
— |
— |
—% |
397 |
400 |
-0.7% |
Cost of Sales |
(1,744) |
(1,715) |
1.7% |
(1,017) |
(1,018) |
-0.1% |
(422) |
(361) |
16.9% |
(55) |
(65) |
-15.4% |
(3,238) |
(3,159) |
2.5% |
As % of net sales |
(25.4)% |
(27.0)% |
|
(42.0)% |
(49.0)% |
|
(36.5)% |
(34.7)% |
|
|
|
|
(31.0)% |
(33.3)% |
|
Gross Profit |
5,155 |
4,674 |
10.3% |
1,744 |
1,418 |
23.0% |
747 |
693 |
7.8% |
(55) |
(65) |
-15.4% |
7,591 |
6,720 |
13.0% |
As % of net sales |
75.2% |
73.5% |
|
72.0% |
68.3% |
|
64.7% |
66.6% |
|
|
|
|
72.8% |
70.9% |
|
Research and development expenses |
(1,104) |
(980) |
12.7% |
(185) |
(178) |
3.9% |
(35) |
(37) |
-5.4% |
(119) |
(126) |
-5.6% |
(1,443) |
(1,321) |
9.2% |
As % of net sales |
(16.1)% |
(15.4)% |
|
(7.6)% |
(8.6)% |
|
(3.0)% |
(3.6)% |
|
|
|
|
(13.8)% |
(13.9)% |
|
Selling and general expenses |
(1,281) |
(1,151) |
11.3% |
(198) |
(193) |
2.6% |
(327) |
(330) |
-0.9% |
(461) |
(508) |
-9.3% |
(2,267) |
(2,182) |
3.9% |
As % of net sales |
(18.7)% |
(18.1)% |
|
(8.2)% |
(9.3)% |
|
(28.3)% |
(31.7)% |
|
|
|
|
(21.7)% |
(23.0)% |
|
Other current operating
income/expenses |
(329) |
(190) |
|
2 |
(2) |
|
77 |
(3) |
|
(39) |
13 |
|
(289) |
(182) |
|
Share of profit/loss of associates* and
joint ventures |
(5) |
(1) |
|
(3) |
2 |
|
3 |
— |
|
— |
— |
|
(5) |
1 |
|
Net income attributable to non
controlling interests |
(27) |
(8) |
|
(1) |
— |
|
(1) |
(1) |
|
— |
— |
|
(29) |
(9) |
|
Business operating income
(2) |
2,409 |
2,344 |
2.8% |
1,359 |
1,047 |
29.8% |
464 |
322 |
44.1% |
(674) |
(686) |
-1.7% |
3,558 |
3,027 |
17.5% |
As % of net sales |
35.1% |
36.8% |
|
56.1% |
50.4% |
|
40.2% |
30.9% |
|
|
|
|
34.1% |
31.9% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income and
expenses |
(85) |
(76) |
|
|
|
|
|
Income tax expenses |
|
|
|
|
(737) |
(652) |
|
|
|
|
|
Tax rate** |
|
|
|
|
21.0% |
22.0% |
|
|
|
|
|
Business net
income |
|
|
|
|
2,736 |
2,299 |
19.0% |
|
|
|
|
As % of net
sales |
|
|
|
|
26.2% |
24.3% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business earnings /
share(in euros)*** |
2.18 |
1.83 |
19.1% |
* 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
1,254.5 million in the third quarter of 2021 and 1,255.7 million in
the third quarter of 2020.
(1) Other includes the cost of global support
functions (Finance, Human Resources, Information Solution &
Technologies, Sanofi Business Services, etc…).(2) The
2020 items have been represented in order to take into account the
reallocation of certain expenses, in particular the IT costs
related to the new Digital organization, which were previously
allocated to the Pharmaceuticals, Vaccines and Consumer Health Care
segments and are now accounted for under "Other".
9 months 2021 |
Pharmaceuticals |
Vaccines |
Consumer Healthcare |
Other(1) |
Total Group |
€ million |
9M 2021 |
9M 2020 |
Change |
9M 2021 |
9M 2020 |
Change |
9M 2021 |
9M 2020 |
Change |
9M 2021 |
9M 2020 |
Change |
9M 2021 |
9M 2020 |
Change |
Net sales |
20,051 |
19,381 |
3.5% |
4,359 |
3,913 |
11.4% |
3,357 |
3,365 |
(0.2)% |
— |
— |
— |
27,767 |
26,659 |
4.2% |
Other revenues |
152 |
98 |
55.1% |
800 |
833 |
(4.0)% |
41 |
43 |
(4.7)% |
— |
— |
— |
993 |
974 |
2.0% |
Cost of Sales |
(5,147) |
(5,121) |
0.5% |
(2,271) |
(2,194) |
3.5% |
(1,175) |
(1,142) |
2.9% |
(186) |
(209) |
(11.0)% |
(8,779) |
(8,666) |
1.3% |
As % of net sales |
(25.7)% |
(26.4)% |
|
(52.1)% |
(56.1)% |
|
(35.0)% |
(33.9)% |
|
|
—% |
|
(31.6)% |
(32.5)% |
|
Gross Profit |
15,056 |
14,358 |
4.9% |
2,888 |
2,552 |
13.2% |
2,223 |
2,266 |
(1.9)% |
(186) |
(209) |
(11.0)% |
19,981 |
18,967 |
5.3% |
As % of net sales |
75.1% |
74.1% |
|
66.3% |
65.2% |
|
66.2% |
67.3% |
|
|
— |
|
72.0% |
71.1% |
|
Research and development expenses |
(3,145) |
(3,045) |
3.3% |
(501) |
(497) |
0.8% |
(104) |
(106) |
(1.9)% |
(356) |
(365) |
(2.5)% |
(4,106) |
(4,013) |
2.3% |
As % of net sales |
(15.7)% |
(15.7)% |
|
(11.5)% |
(12.7)% |
|
(3.1)% |
(3.2)% |
|
|
— |
|
(14.8)% |
(15.1)% |
|
Selling and general expenses |
(3,761) |
(3,539) |
6.3% |
(557) |
(562) |
(0.9)% |
(1,027) |
(1,074) |
(4.4)% |
(1,452) |
(1,614) |
(10.0)% |
(6,797) |
(6,789) |
0.1% |
As % of net sales |
(18.8)% |
(18.3)% |
|
(12.8)% |
(14.4)% |
|
(30.6)% |
(31.9)% |
|
|
— |
|
(24.5)% |
(25.5)% |
|
Other current operating
income/expenses |
(795) |
(340) |
|
123 |
2 |
|
100 |
18 |
|
(17) |
(117) |
|
(589) |
(437) |
|
Share of profit/loss of associates* and
joint ventures |
8 |
3 |
|
5 |
2 |
|
8 |
7 |
|
— |
— |
|
21 |
12 |
|
Net income attributable to non
controlling interests |
(43) |
(25) |
|
(1) |
— |
|
(5) |
(5) |
|
— |
— |
|
(49) |
(30) |
|
Business operating
income (2) |
7,320 |
7,412 |
(1.2)% |
1,957 |
1,497 |
30.7% |
1,195 |
1,106 |
8.0% |
(2,011) |
(2,305) |
(12.8)% |
8,461 |
7,710 |
9.7% |
As % of net sales |
36.5% |
38.2% |
|
44.9% |
38.3% |
|
35.6% |
32.9% |
|
|
|
|
30.5% |
28.9% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income and
expenses |
(246) |
(243) |
|
|
|
|
|
|
|
|
Income tax expenses |
|
(1,731) |
(1,647) |
|
|
|
|
|
|
|
|
Tax rate** |
|
21.0% |
22.0% |
|
|
|
|
|
|
|
|
Business net
income |
|
6,484 |
5,820 |
11.4% |
|
|
|
|
|
|
|
As % of net
sales |
|
23.4% |
21.8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business earnings /
share(in euros)*** |
5.18 |
4.64 |
11.6% |
* 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 1,251.7 million in the
first nine months of 2021 and 1,253 million in the first nine
months of 2020.
(1) Other includes the cost of global support
functions (Finance, Human Resources, Information Solution &
Technologies, Sanofi Business Services, etc…).(2) The
2020 items have been represented in order to take into account the
reallocation of certain expenses, in particular the IT costs
related to the new Digital organization, which were previously
allocated to the Pharmaceuticals, Vaccines and Consumer Health Care
segments and are now accounted for under "Other".
Appendix 3: Consolidated income
statements
€
million |
Q3 2021 |
Q3 2020 |
9M 2021 |
9M 2020 |
Net
sales |
10,432 |
|
9,479 |
|
27,767 |
|
26,659 |
|
Other revenues |
397 |
|
400 |
|
993 |
|
974 |
|
Cost of sales |
(3,238) |
|
(3,176) |
|
(8,779) |
|
(8,719) |
|
Gross
profit |
7,591 |
|
6,703 |
|
19,981 |
|
18,914 |
|
Research and development expenses |
(1,443) |
|
(1,321) |
|
(4,106) |
|
(4,013) |
|
Selling and general expenses |
(2,267) |
|
(2,182) |
|
(6,797) |
|
(6,789) |
|
Other operating income |
259 |
|
242 |
|
668 |
|
523 |
|
Other operating expenses |
(548) |
|
(424) |
|
(1,257) |
|
(1,117) |
|
Amortization of intangible assets |
(385) |
|
(404) |
|
(1,160) |
|
(1,287) |
|
Impairment of intangible assets (1) |
1 |
|
(2) |
|
(177) |
|
(325) |
|
Fair value remeasurement of contingent consideration |
5 |
|
22 |
|
1 |
|
76 |
|
Restructuring costs and similar items |
(167) |
|
(110) |
|
(494) |
|
(868) |
|
Other gains and losses, and litigation (2) |
(4) |
|
— |
|
(4) |
|
136 |
|
Gain on Regeneron investment as result of transaction completed on
May 29th, 2020 (3) |
— |
|
— |
|
— |
|
7,382 |
|
Operating income |
3,042 |
|
2,524 |
|
6,655 |
|
12,632 |
|
Financial expenses |
(87) |
|
(91) |
|
(276) |
|
(289) |
|
Financial income |
2 |
|
15 |
|
30 |
|
46 |
|
Income
before tax and associates and joint ventures |
2,957 |
|
2,448 |
|
6,409 |
|
12,389 |
|
Income tax expense |
(609) |
|
(490) |
|
(1,291) |
|
(1,484) |
|
Share of profit/(loss) of associates and joint ventures |
(5) |
|
1 |
|
21 |
|
355 |
|
Net
income |
2,343 |
|
1,959 |
|
5,139 |
|
11,260 |
|
Net income attributable to non-controlling interests |
26 |
|
7 |
|
46 |
|
27 |
|
Net
income attributable to equity holders of Sanofi |
2,317 |
|
1,952 |
|
5,093 |
|
11,233 |
|
Average number
of shares outstanding (million) |
1,254.5 |
|
1,255.7 |
|
1,251.7 |
|
1,253.0 |
|
IFRS Earnings per share (in euros) |
1.85 |
|
1.55 |
|
4.07 |
|
8.96 |
|
(1) In 2021 and 2020, mainly related to
Sutimlimab impairments.(2) In 2020, includes
mainly the gain on the sale of operations related to the Seprafilm
product to Baxter.(3) In 2020, this line includes
the pre-tax income from the sale of Regeneron shares following the
public offer for sale and Regeneron's repurchase on May 29, 2020.
This amount includes the gain related to the remeasurement at fair
value of the 400,000 retained shares that could be used to finance
the R&D collaboration under the letter of agreement dated
2018.
Appendix 4: Reconciliation of Net income attributable to
equity holders of Sanofi to Business net income
€
million |
Q3 2021 |
Q3 2020 |
9M 2021 |
9M 2020 |
Net
income attributable to equity holders of Sanofi |
2,317 |
|
1,952 |
|
5,093 |
|
11,233 |
|
Amortization of
intangible assets (1) |
385 |
|
404 |
|
1,160 |
|
1,287 |
|
Impairment of
intangible assets (2) |
(1) |
|
2 |
|
177 |
|
325 |
|
Fair value
remeasurement of contingent consideration |
(5) |
|
(22) |
|
(1) |
|
(76) |
|
Expenses arising
from the impact of acquisitions on inventories |
— |
|
17 |
|
— |
|
53 |
|
Restructuring
costs and similar items |
167 |
|
110 |
|
494 |
|
868 |
|
Other gains and
losses, and litigation (3) |
4 |
|
— |
|
4 |
|
(136) |
|
Gain on sale of
Regeneron shares on May 29, 2020 (4) |
— |
|
— |
|
— |
|
(7,225) |
|
Tax effect of
the items listed above: |
(129) |
|
(162) |
|
(440) |
|
(163) |
|
Amortization and impairment of intangible assets |
(90) |
|
(122) |
|
(320) |
|
(424) |
|
Fair value remeasurement of contingent consideration |
(1) |
|
(1) |
|
2 |
|
1 |
|
Expenses arising from the impact of acquisitions on
inventories |
— |
|
(3) |
|
— |
|
(8) |
|
Restructuring costs and similar items |
(37) |
|
(29) |
|
(121) |
|
(261) |
|
Gain on sale of Regeneron shares on May 29, 2020 |
— |
|
— |
|
— |
|
475 |
|
Other tax effects |
(1) |
|
(7) |
|
(1) |
|
54 |
|
Share of items
listed above attributable to non-controlling interests |
(2) |
|
(2) |
|
(3) |
|
(3) |
|
Restructuring
costs of associates and joint ventures, and expenses arising from
the impact of acquisitions on associates and joint ventures |
— |
|
— |
|
— |
|
(30) |
|
Effect of
discontinuation of use of equity method for Regeneron investment
(5) |
— |
|
— |
|
— |
|
(313) |
|
Business
net income |
2,736 |
|
2,299 |
|
6,484 |
|
5,820 |
|
IFRS earnings per share (6)
(in euros) |
1.85 |
|
1.55 |
|
4.07 |
|
8.96 |
|
(1) Of which related to amortization expense
generated by the remeasurement of intangible assets as part of
business combinations: €361 million in the third quarter of 2021
and €383 million in the third quarter of 2020.
(2) In 2021 and 2020, mainly related to
Sutimlimab impairments.
(3) In 2020, includes mainly the gain on the
sale of operations related to the Seprafilm product to Baxter.
(4) This line includes the result of the sale
of 13 million of Regeneron’s shares as part of the public offering
and of the 9.8 million of its shares repurchased by Regeneron. The
amount does not include the gain related to the remeasurement at
fair value at this date of the 400,000 retained shares.
(5) Our non-GAAP indicator (Business Net
Income) does not include the share of income related to equity
accounting from Regeneron since it ceased to be an associate on May
29, 2020. As a result, this line reflects that exclusion up to this
date.
(6) Q3: Based on an average number of shares
outstanding of 1,254.5 million in the third quarter of 2021 and
1,255.7 million in the third quarter of 2020.
9M : Based on an average number of shares outstanding of 1,251.7
million in the first nine months of 2021 and 1,253 million in the
first nine months of 2020.
Appendix 5: Change in net
debt
€
million |
9M 2021 |
9M 2020 |
(1) |
Business
net income |
6,484 |
|
5,820 |
|
|
Depreciation
& amortization & impairment of property, plant and
equipment and software |
1,102 |
|
1,125 |
|
|
Other items |
117 |
|
592 |
|
|
Operating cash flow |
7,703 |
|
7,537 |
|
|
Changes in
Working Capital |
218 |
|
(933) |
|
|
Acquisitions of
property, plant and equipment and software |
(953) |
|
(847) |
|
|
Free
cash flow before restructuring, acquisitions and
disposals |
6,968 |
|
5,757 |
|
|
Acquisitions of
intangibles assets, investments and other long-term financial
assets (2) |
(1,093) |
|
(447) |
|
|
Restructuring
costs and similar items paid |
(781) |
|
(660) |
|
|
Proceeds from
disposals of property, plant and equipment, intangible assets and
other non-current assets net of taxes (2) |
461 |
|
802 |
|
|
Free
cash flow |
5,555 |
|
5,452 |
|
|
Acquisitions of
investments in consolidated undertakings includingassumed debt
(3) |
(3,385) |
|
(5,767) |
|
|
Proceeds from
Sale of Regeneron Shares on May 29,2020 net of taxes |
— |
|
10,332 |
|
|
Issuance of
Sanofi shares |
175 |
|
194 |
|
|
Acquisition of
treasury shares |
(140) |
|
(361) |
|
|
Dividends paid
to shareholders of Sanofi |
(4,008) |
|
(3,937) |
|
|
Other items |
166 |
|
(450) |
|
|
Change in net debt |
(1,637) |
|
5,463 |
|
|
Beginning of period |
8,790 |
|
15,107 |
|
|
Closing of net debt |
10,427 |
|
9,644 |
|
|
(1) Excluding any effect of equity method
accounting for Regeneron investment for comparison purposes.
(2) Free cash flow includes investments and
divestments not exceeding a cap of €500 million per transaction
(inclusive of all payments related to the transaction).
(3) Includes transactions that are above a cap
of €500 million per transaction (inclusive of all payments related
to the transaction).
Appendix 6: Currency sensitivity
2021 business EPS currency sensitivity
Currency |
Variation |
Business EPS Sensitivity |
U.S. Dollar |
+0.05 USD/EUR |
-EUR 0.13 |
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 0.02 |
Currency exposure on Q3 2021 sales
Currency |
Q3 2021 |
US $ |
43.8 |
% |
Euro € |
20.1 |
% |
Chinese
Yuan |
7.1 |
% |
Japanese
Yen |
3.9 |
% |
Brazilian
Real |
1.7 |
% |
Canadian $ |
1.6 |
% |
British
Pound |
1.5 |
% |
Mexican
Peso |
1.3 |
% |
Russian
ruble |
1.3 |
% |
South Korean
won |
1.1 |
% |
Others |
16.6 |
% |
Currency average rates
|
Q3 2020 |
Q3 2021 |
Change |
9M 2020 |
9M 2021 |
Change |
€/$ |
1.17 |
|
1.18 |
|
+0.8 |
% |
1.12 |
|
1.20 |
|
+6.5 |
% |
€/Yen |
124.05 |
|
129.79 |
|
+4.6 |
% |
120.84 |
|
129.80 |
|
+7.4 |
% |
€/Yuan |
8.09 |
|
7.63 |
|
-5.7 |
% |
7.87 |
|
7.74 |
|
-1.60 |
% |
€/Real |
6.29 |
|
6.16 |
|
-2.0 |
% |
5.71 |
|
6.38 |
|
+11.8 |
% |
€/Ruble |
86.28 |
|
86.60 |
|
+0.4 |
% |
79.87 |
|
88.60 |
|
+10.9 |
% |
Appendix 7: Definitions of non-GAAP financial
indicators
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 third quarter and In the first nine months
2021
€
million |
Q3 2021 |
9M 2021 |
Net
sales |
10,432 |
|
27,767 |
|
Effect of
exchange rates |
— |
|
(1,075) |
|
Company sales at constant exchange rates |
10,432 |
|
28,842 |
|
Business net income
Sanofi publishes a key non-GAAP indicator.
Following the Regeneron shares transaction that was completed on
May 29, 2020, the definition of the non-GAAP financial measure
“Business net income” has been revised such that Share of
profit/(loss) from investments accounted for using the equity
method excludes the effects of applying the equity method
to the investment in Regeneron. The comparative periods of 2019
presented have been restated to reflect that adjustment.
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),
-
gain on Regeneron investment as a result of the transaction
completed on May 29, 2020 (the amount does not include the gain
related to the remeasurement at fair value at this date of the
400,000 retained shares),
-
tax effects related to the items listed above as well as effects of
major tax disputes,
-
effect of equity method accounting for Regeneron investment
(excluded from Business net income as a consequence of the sale of
the entire equity investment in Regeneron (with the exception of
400,000 shares retained by Sanofi) on May 29th 2020,
-
net income attributable to non-controlling interests related to the
items listed above.
(1) 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.
Free cash flow
Free cash flow is a non-GAAP financial indicator
which is reviewed by our management, and which we believe provides
useful information to measure the net cash generated from the
Company’s operations that is available for strategic investments1
(net of divestments1), for debt repayment, and for capital return
to shareholders. Free Cash Flow is determined from the Business Net
Income adjusted for depreciation, amortization and impairment,
share of profit/loss in associates and joint ventures net of
dividends received, gains & losses on disposals, net change in
provisions including pensions and other post-employment benefits,
deferred taxes, share-based expense and other non-cash items. It
comprises net changes in working capital, capital expenditures and
other asset acquisitions2 net of disposal proceeds2, and payments
related to restructuring and similar items. Free cash flow is not
defined by IFRS and it is not a substitute measure for the IFRS
aggregate net cash flows in operating activities.
1 Amount of the transaction above a cap of €500 million per
transaction (inclusive of all payments related to the
transaction).
2 Not exceeding a cap of €500 million per transaction (inclusive
of all payments related to the transaction).
1 See Appendix 7 for definitions of financial indicators.2
Sanofi has prioritized core assets in its General Medicines
portfolio with differentiated and/or established profiles that have
significant opportunity for growth in key markets. Core assets
include Toujeo, Soliqua, Praluent, Multaq, Lovenox, Plavix and
others for total sales of €5.6bn in 20203 API and Drug Product
manufacturing in Sanofi sites for third party 4 Announced on
September 8, 2021; Subject to satisfaction or waiver of customary
closing conditions, Sanofi expects to complete the acquisition in
Q4 20215Net zero is achieved when company emissions of greenhouse
gases to the atmosphere are balanced by removals elsewhere over a
specified period.6Carbon neutrality is achieved when company
emissions of greenhouse gases to the atmosphere are balanced by
reduction or avoidance elsewhere over a specified period. 7RE100 is
a global initiative bringing together the world's most influential
businesses committed to 100% renewable electricity8See Appendix 3
for 2021 third-quarter consolidated income statement; see Appendix
7 for definitions of financial indicators, and Appendix 4 for
reconciliation of IFRS net income reported to business net income.
9 Not exceeding €500 million per transaction (inclusive of all
payments related to the transaction).10 non-GAAP financial measure
(definition in Appendix 7).
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