Paris, April 28,
2021
Sanofi continued its growth
trajectory. Strong increase in Q1
2021 business EPS(1)
at CER.
Q1 2021 sales increase of 2.4% at CER driven by
growth drivers Dupixent® and
Vaccines
- Specialty Care sales
grew 15.3%, due to strong Dupixent® performance (+45.6% to €1,047
million) and oncology launches
- Vaccines up 5.3%,
driven by PPH franchise and demand for influenza vaccines in
southern hemisphere
- General Medicines
core assets grew 4.4%, while GBU sales were down 3.8%
- CHC decreased 7.3%
due to COVID related stocking in Q1 2020 and low demand for cough
and cold brands in Europe
Q1 2021 business
EPS(1) growth at
CER driven by efficiency and sales performance, supported by a
one-time payment
- Business EPS(1) was
€1.61 up 5.2% on a reported basis and up 15.0% at CER
- Business EPS(1)
includes an incremental 8 cents due to a payment related to the
termination of a collaboration in Japan
- IFRS EPS was
€1.25
Progress on implementation of the Corporate
Social Responsibility strategy
- Sanofi has become a
member of the top five companies of the 2021 Access to Medicine
index
- Sanofi announced
Sanofi Global Health, a newly formed non-profit unit within the
company, a new cornerstone of its CSR strategy
Full-year 2021 business EPS guidance
affirmed
-
Sanofi expects 2021 business EPS(1) to grow high single digit(2) at
CER, barring unforeseen major adverse events. Applying average
April 2021 exchange rates, the currency impact on 2021 business EPS
is estimated to be between -4% to -5%.
Sanofi Chief Executive Officer, Paul Hudson,
commented:
“Our strong first-quarter performance is the
result of the continued execution of our Play to Win strategy to
drive growth and bring innovative medicines to patients. Dupixent®
continues its outstanding performance with impressive growth in the
U.S. and strong uptake in global markets, including China. Vaccines
delivered growth in its core segments. We initiated and completed
enrollment of our Phase 2 study for our recombinant COVID-19
vaccine candidate in the first quarter and results are expected
next month. Following the communication of our ESG strategy at the
end of 2020 and embedding it into our business priorities, we have
recently created the Sanofi Global Health Unit, dedicated to
increasing access to 30 medicines considered essential by the WHO.
Sanofi is uniquely positioned to make this difference to society,
which can be scaled and sustained over time, given our portfolio of
essential medicines and broad geographic presence.”
|
Q1 2021 |
Change |
Change at CER |
IFRS net sales
reported |
€8,591m |
-4.3% |
+2.4% |
IFRS net income
reported |
€1,566m |
-7.0% |
_ |
IFRS EPS reported |
€1.25 |
-7.4% |
_ |
Free cash flow(3) |
€1,925m |
+23.6% |
_ |
Business
operating income |
€2,638m |
+4.0% |
+13.3% |
Business net
income(1) |
€2,017m |
+5.1% |
+14.7% |
Business EPS(1) |
€1.61 |
+5.2% |
+15.0% |
Changes in net sales are expressed at constant exchange rates
(CER) unless otherwise indicated (definition in Appendix 7)(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 (definition in Appendix 7).
The consolidated income statement for Q1 2021 is provided in
Appendix 3 and a reconciliation of reported IFRS net income to
business net income is set forth in Appendix 4; (2) 2020 restated
business EPS was €5.86; (3) Free cash flow is a non-GAAP financial
measure (definition in Appendix 7).
2021 first-quarter Sanofi
sales
----------------------------Unless otherwise
indicated, all percentage changes in sales in this press release
are stated at CER1
----------------------------
In the first quarter of 2021, Sanofi sales were
€8,591 million, down 4.3% on a reported basis. Exchange rate
movements had a negative effect of 6.7 percentage points, mainly
driven by the decrease of the U.S. dollar, Brazilian real, Russian
ruble, Turkish lira, and Argentine peso and Japanese yen. At CER,
Sanofi sales increased 2.4%.
Global Business
Units
First-quarter 2021 operating
income
First-quarter business operating
income (BOI) increased 4.0% to €2,638 million. At
CER, BOI increased 13.3%. The ratio of BOI to net sales increased
2.4 percentage points to 30.7% versus the prior year.
Pharmaceuticals
First-quarter 2021 Pharmaceutical sales
increased 3.8% to €6,563 million, with double-digit growth of the
Specialty Care portfolio mainly driven by the strong performance of
Dupixent® which largely offset lower sales in General Medicines in
Europe and the U.S.
Specialty
Care
Dupixent
Net sales (€ million) |
Q1 2021 |
Change at CER |
Total Dupixent® |
1,047 |
|
+45.6 |
% |
In the first quarter, Dupixent® (collaboration
with Regeneron) sales were strong despite the COVID-19 environment
and increased 45.6% to €1,047 million. In the U.S., Dupixent® sales
of €793 million (up 41.6%) were driven by continued strong demand
in atopic dermatitis (AD) in adult, adolescent patients, and
children aged 6 to 11 years, continued uptake in asthma and chronic
rhinosinusitis with nasal polyposis (CRSwNP). Dupixent® total
prescriptions (TRx) increased 51% (year-over-year) and new-to-brand
prescriptions (NBRx) grew 16% despite fewer in-person physician
visits which remain below the pre-COVID level. In Europe,
first-quarter Dupixent® sales grew 52.2% to €137 million reflecting
continued growth in AD in key countries and additional launches in
asthma in European markets. In Japan, sales were €59 million (up
53.7%), where strong demand was moderated by the government price
decrease implemented in April 2020. Dupixent® was approved in China
for the treatment of adults with moderate-to-severe AD in June 2020
and is listed on the NRDL (National Reimbursement Drug List) as of
March 2021. At the end of the first quarter, Dupixent® was launched
in 49 countries with approximately 260 000 patients on
therapy.
Neurology and
Immunology
Net sales (€
million) |
Q1 2021 |
Change at CER |
Aubagio® |
500 |
|
-1.1 |
% |
Lemtrada® |
24 |
|
-44.9 |
% |
Kevzara® |
57 |
|
+10.9 |
% |
Total Neurology and Immunology |
581 |
|
-3.4 |
% |
In the first-quarter, Neurology and
Immunology sales were down 3.4% to €581 million, impacted
primarily by the decline of Lemtrada® sales.
Aubagio® sales decreased 1.1%
in the first quarter to €500 million, due to lower sales in the
U.S. reflecting increased competition partially offset by demand
growth partly related to clinical trial supply and price upside in
Europe.
First-quarter Lemtrada® sales
decreased 44.9% to €24 million, primarily due to the COVID-19
pandemic, which has led to a decrease in infused immune
reconstitution therapies such as Lemtrada®.
First-quarter Kevzara®
(collaboration with Regeneron) sales were up 10.9% to €57 million
driven by Europe and Rest of the World which largely offset lower
U.S. sales reflecting the recent strategic decision to reduce
promotional efforts.
Rare
Disease
Net sales (€
million) |
Q1 2021 |
Change at CER |
Myozyme® / Lumizyme® |
235 |
|
+0.8 |
% |
Fabrazyme® |
208 |
|
+4.7 |
% |
Cerezyme® |
178 |
|
+4.2 |
% |
Aldurazyme® |
66 |
|
+7.5 |
% |
Cerdelga® |
62 |
|
+13.8 |
% |
Others
Rare Disease |
21 |
|
+10.0 % |
Total Rare Disease |
770 |
|
+4.4 |
% |
In the first quarter, Rare
Disease sales increased 4.4% to €770 million, primarily
driven by higher demand particularly in Rest of the World (up
10.2%). Sales in Europe increased 0.4% and compared to a high base
in the first quarter of 2020 due to an inventory build related to
the COVID-19 environment.
First-quarter Cerezyme® sales
increased 4.2% to €178 million, driven by strong growth in Rest of
the World (up 18.4%). First-quarter Cerdelga®
sales increased 13.8% to €62 million driven by new patient accruals
in the three regions. Sales of the Gaucher
franchise (Cerezyme® + Cerdelga®) increased 6.5% (to €240 million)
in the first quarter.
First-quarter
Myozyme®/Lumizyme® sales increased 0.8% to €235
million supported by new patient accruals in the U.S. (up 11.5%)
which offset lower sales in Europe and negative phasing effect in
Rest of the World.
First-quarter Fabrazyme® sales
increased 4.7% to €208 million driven by higher sales in Rest of
the World and Europe. In the U.S. sales decreased 2.9% reflecting
lower treatment compliance during the COVID-19 pandemic.
Oncology
Net sales (€
million) |
Q1 2021 |
Change at CER |
Jevtana® |
126 |
|
-2.9 |
% |
Fasturtec® |
35 |
|
+8.6 |
% |
Libtayo® |
26 |
|
+125.0 |
% |
Sarclisa® |
34 |
|
+3400.0 |
% |
Total Oncology |
221 |
|
+25.8 |
% |
First-quarter Oncology sales increased 25.8% to
€221 million, driven by the Sarclisa® and Libtayo® launches.
First-quarter Jevtana® sales
decreased 2.9% to €126 million following the entry of generic
competition in Europe (down 11.8%) at the end of March. In the
U.S., sales were up 5.0%. In the U.S., the Jevtana® composition of
matter patent will expire in September 2021. From May to July 2020,
Sanofi filed patent infringement suits against all generic filers
on Jevtana® under Hatch-Waxman in the U.S. District Court for the
District of Delaware asserting two method of use patents (US
10,583,110 and US 10, 716,777), both of which expire in October
2030. Sanofi has reached settlement agreements with some of the
defendants and the suit against the remaining defendants currently
stayed. In Europe, generic competition has started in certain
countries after the expiration of Jevtana®’s market exclusivity in
March 2021.
Libtayo® (collaboration with
Regeneron) sales were €26 million (up 125.0%) in the first quarter
driven by increased demand in metastatic cutaneous squamous cell
carcinoma (CSCC) as well as additional country launches. In
February, Libtayo® was approved in two new indications in the U.S.
as a monotherapy for patients with first-line advanced non-small
cell lung cancer with PD-L1 expression of ≥50% and for patients
with advanced basal cell carcinoma. Libtayo® sales in the U.S. are
reported by Regeneron.
Sarclisa® was approved in March
2020 in the U.S. for the treatment of adults with relapsed
refractory multiple myeloma (RRMM) who have received at least two
prior therapies including lenalidomide and a proteasome inhibitor
and in June by the European Commission in certain adults with RRMM.
First-quarter Sarclisa® sales were €34 million driven by additional
country launches. First-quarter sales in the U.S. and in Europe
were €12 million and €13 million, respectively. In Rest of the
World sales (€9 million) were driven by a strong performance in
Japan. At the end of March, the FDA approved Sarclisa® in
combination with carfilzomib and dexamethasone for patients with
relapsed multiple myeloma.
Rare Blood
Disorder
Net sales (€
million) |
Q1 2021 |
Change at CER |
Eloctate® |
134 |
|
-9.9 |
% |
Alprolix® |
100 |
|
-1.8 |
% |
Cablivi® |
38 |
|
+66.7 |
% |
Total Rare Blood Disorder |
272 |
|
-0.7 |
% |
In the first quarter, Rare Blood
Disorder franchise sales were down 0.7% (€272 million).
Excluding industrial sales to Sobi, first-quarter sales were up
5.1% driven by Alprolix® and Cablivi® performance which more than
offset Eloctate® sales decrease in the U.S. As already
communicated, Alprolix® and Eloctate® industrial sales to Sobi are
expected to be significantly lower in 2021 than in 2020.
Eloctate® sales were €134
million in the first quarter, down 9.9%. Excluding industrial sales
to Sobi, Eloctate sales were down 3.4% mainly due to lower U.S.
sales (-5.0%) as a result of ongoing competitive pressure. Sales in
the Rest of the World were down 23.8% reflecting lower industrial
sales to Sobi.
First-quarter Alprolix® sales
were down 1.8% to €100 million. Excluding industrial sales to Sobi,
Alprolix sales were up 3.0%, mainly driven by patient switches from
standard half-life factors and prophylaxis conversion. Sales in the
Rest of the World were down 19.2% reflecting lower industrial sales
to Sobi.
Cablivi® for the treatment of
adults with acquired thrombotic thrombocytopenic purpura (aTTP), a
rare and acute blood disorder, generated sales of €38 million (up
66.7%) in the first quarter of which €22 million from the U.S. (up
60%) driven by increase disease and product awareness as well as
adoption of new ISTH (International Society on Thrombosis and
Haemostasis) TTP guidelines. In Europe, sales were €15 million (up
66.7%) driven by new country launches. Globally, diagnosis of the
disease and product awareness remain impacted by the COVID-19
environment.
General Medicines
General Medicines sales were down 3.8% to €3,672
million in the first quarter. Sales of the core assets2 were 1,474
million up 4.4% (and up 6.3% excluding Praluent® U.S. sales3),
driven by strong performance of Lovenox®. Non-core assets sales
were €2,010 million, down 9.9% reflecting notably portfolio
streamlining, lower Lantus® and Aprovel®/Avapro® sales and some
negative COVID-19 impact. First-quarter industrial sales were €188
million up 8.8%.
Diabetes
Net sales (€
million) |
Q1 2021 |
Change at CER |
Lantus® |
652 |
|
-3.7 |
% |
Toujeo® |
253 |
|
+5.1 |
% |
Total glargine |
905 |
|
-1.4 |
% |
Soliqua® |
44 |
|
+29.7 |
% |
Other
diabetes |
226 |
|
-7.3 |
% |
Total Diabetes |
1,175 |
|
-1.7 |
% |
In the first quarter, global
Diabetes sales decreased 1.7% to €1,175 million.
The growth in the Rest of the World (up 5.3%) was driven by
Lantus®, Toujeo® launch in China and Soliqua® performance. In the
U.S., the Diabetes sales decrease 5.3%. In Europe, sales decreased
10.2% largely affected by patient stockpiling related to the
COVID-19 environment in the first quarter of 2020.
First-quarter Toujeo® sales
increased 5.1% to €253 million driven by the launch in China. Lower
sales in Europe reflected the high base in the first quarter 2020
due to patient stockpiling. In the U.S., Toujeo® sales were stable
with volume growth offsetting average price decrease.
Lantus® sales were €652
million, down 3.7% in the first quarter, mainly due to a continued
decline in average U.S. net price, increasing usage of Toujeo®,
biosimilar glargine competition and lower sales in Europe (patient
stockpilling in the first quarter of 2020). In Rest of the World,
sales increased 4.9%.
First-quarter Soliqua® sales
increased 29.7% to €44 million driven by growth in the three
regions and notably by launches in Rest of the World (up 44.4%) and
performance in the U.S. (up 27.3%)
Cardiovascular and Established
Rx Products
Net sales (€
million) |
Q1 2021 |
Change at CER |
Lovenox®* |
401 |
|
+30.4 |
% |
Plavix®* |
251 |
|
-4.0 |
% |
Aprovel®/Avapro® |
101 |
|
-39.7 |
% |
Thymoglobulin® |
80 |
|
+1.2 |
% |
Multaq® |
72 |
|
-3.7 |
% |
Praluent® |
56 |
|
-20.5 |
% |
Mozobil® |
52 |
|
+1.9 |
% |
Generics |
206 |
|
+3.5 |
% |
Other |
1,090 |
|
-12.2 |
% |
Total Cardiovascular and Established Rx
Products |
2,309 |
|
-5.6 |
% |
*Excluding Auto generics
In the first quarter, Cardiovascular and
Established Rx Products sales decreased 5.6% to €2,309
million reflecting strong Lovenox® growth more than offset in
particular by lower sales of Aprovel®/Avapro®, divestments and some
COVID impact.
First-quarter Lovenox® sales
increased 30.4% to €401 million, driven by Rest of the World (up
50.7%), and Europe (up 10.5%) reflecting demand increase driven by
recent guidelines recommending the use of low molecular weight
heparins in hospitalized COVID-19 patients which more than offset
biosimilar competition and postponed procedures.
Plavix® sales were down 4.0% in
the first quarter to €251 million mainly reflecting lower sales in
Europe (down 23.7%) and Japan. In China, first-quarter Plavix®
sales were €117 million, up 0.8%.
First-quarter Aprovel®/Avapro®
sales were down 39.7%% to €101 million, primarily reflecting a
short-term supply constraint.
First-quarter Praluent® sales
decreased 20.5% to €56 million, due to lower sales in the U.S.
reflecting the restructuring of the collaboration with Regeneron
which was effective on 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. sales3
, Praluent® sales grew 26.8% driven by a strong performance in
Europe (up 20.0%) and Rest of the World (up 45.5%) driven by the
launch in China. Praluent® was relaunched in Germany at the
beginning of April 2021.
Multaq® sales were €72 million,
down 3.7% in the first quarter due to lower sales in the U.S.
impacted by the COVID-19 environment.
Pharmaceuticals business
operating income
In the first quarter, business operating
income (BOI) of Pharmaceuticals decreased 4.6% to €2,515
million (up 2.9% at CER). The ratio of BOI to net sales decreased
by 0.7 percentage points to 38.3%. At CER, the ratio decreased 0.4
percentage points reflecting higher SG&A spends as well as
increased “Other operating expenses” mainly reflected Regeneron
MAbs alliance despite an improvement of the gross margin.
Vaccines
Net sales (€
million) |
Q1 2021 |
Change at CER |
Polio/Pertussis/Hib vaccines (incl.
Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®) |
533 |
|
+14.9 |
% |
Influenza vaccines(incl. Vaxigrip®,
Fluzone HD®, Fluzone® & Flublok®) |
77 |
|
+23.8 |
% |
Meningitis/Pneumo vaccines (incl.
Menactra®) |
128 |
|
+3.8 |
% |
Adult Booster vaccines (incl. Adacel
®) |
100 |
|
-8.7 |
% |
Travel and other endemic vaccines |
59 |
|
-37.4 |
% |
Other
vaccines |
18 |
|
+17.6 |
% |
Total Vaccines |
915 |
|
+5.3 |
% |
First-quarter Vaccines sales
increased 5.3% to €915 million reflecting higher PPH vaccines sales
and strong flu vaccines demand partly offset by lower sales of
travel vaccines and adult booster due to the COVID-19 pandemic.
Influenza vaccines sales
increased by 23.8% in the first quarter to €77 million, reflecting
strong demand in the southern hemisphere which were partly offset
by the U.S. due to the earlier supply to the market as compared to
the 2019/2020 flu season.
In the first quarter,
Polio/Pertussis/Hib (PPH) vaccines sales increased
14.9% to €533 million benefiting from the favorable phasing of
shipments. In the U.S., PPH sales were up 40.4% driven by the
timing of the CDC order for Pentacel® and in the rest of the World,
strong polio vaccines sales reflected the favorable phasing of
public tenders. Supply for Vaxelis® in the US will be available in
June 2021. Developed as part of a joint-partnership between Sanofi
and Merck, Vaxelis® is the first and only hexavalent combination
vaccine approved in the U.S. to help protect infants and children
against six infectious diseases, including diphtheria, tetanus,
pertussis (whooping cough), poliomyelitis, hepatitis B and invasive
disease due to Haemophilus influenzae type b. Vaxelis® in market
sales will not be consolidated.
First-quarter Menactra® sales
were up 3.8% to €127 million. MenQuadfi®, which is the only U.S.
FDA-approved quadrivalent meningococcal vaccine indicated for all
patients above 2 years of age, was launched in the U.S. in March
2021.
Adult Booster vaccines sales
decreased 8.7% in the first quarter to €100 million, primarily
reflecting the COVID-19 impact on Adacel® in the U.S. and Repevax®
in Europe.
First-quarter Travel and other endemic
vaccines sales decreased 37.4%, due to extensive travel
restrictions globally.
Vaccines business operating
income
In the first quarter, business operating
income (BOI) of Vaccines increased 43.2% to €371 million
reflecting the payment from Daiichi Sankyo. At CER, BOI increased
48.6%. The ratio of BOI to net sales was 40.5% (and 27.5% excluding
the payment from Daiichi Sankyo).
Consumer
Healthcare
Net sales (€
million) |
Q1 2021 |
Change at CER |
Allergy |
195 |
|
-6.2 |
% |
Cough, Cold and Flu |
55 |
|
-59.4 |
% |
Pain Care |
253 |
|
-11.6 |
% |
Digestive Wellness |
283 |
|
+14.6 |
% |
Physical Wellness |
81 |
|
+2.3 |
% |
Mental Wellness |
53 |
|
+18.8 |
% |
Personal Care |
125 |
|
+2.2 |
% |
Non-Core / Others |
68 |
|
-15.3 |
% |
Total Consumer
Healthcare |
1,113 |
|
-7.3 |
% |
In the first quarter, Consumer
Healthcare (CHC) sales decreased 7.3% to €1,113 million
primarily reflecting a weak cough and cold season due to social
distancing measures and wearing of masks as well as a high base for
comparison in the first quarter of 2020 which benefited from pantry
loading related to COVID environment. First-quarter sales were also
impacted by divestments of non-core products.
In the U.S., first-quarter CHC
sales increased 2.3% to €283 million, reflecting growth of
Digestive and Mental Wellness categories as well as Allergy
partially offset by the decline of the Pain category.
In Europe, first-quarter CHC
sales decreased 19.3% (to €334 million) mainly reflecting lower
incidence of colds due to social distancing measures and wearing of
masks, as well as a high base for comparison in the first quarter
of 2020 which benefited from pantry loading related to COVID
environment. First quarter CHC sales were also impacted by
divestments of non-core products.
In the Rest of the World,
first-quarter CHC sales decreased 3.6% to €496 million, reflecting
lower sales in Allergy, Cough and Cold and pain categories impacted
by the COVID environment partially offset by the growth of the
Digestive and Mental Wellness categories.
CHC business operating
income
In the first quarter, business operating
income (BOI) of CHC decreased 18.4% to €394 million. At
CER, BOI decreased 8.9% reflecting lower sales. The ratio of BOI to
net sales decreased 1.8 percentage point to 35.4% versus the prior
year.
Company sales by geographic
region
Sanofi sales (€
million) |
Q1 2021 |
Change at CER |
United States |
2,893 |
|
+6.4% |
Europe |
2,228 |
|
-5.6% |
Rest of the World |
3,470 |
|
+4.3% |
of which China |
726 |
|
+8,4% |
of which Japan |
434 |
|
-8,7% |
of which Brazil |
258 |
|
+22,2% |
of which
Russia |
151 |
|
-6,2% |
Total Sanofi sales |
8,591 |
|
+2.4 % |
First-quarter sales in the U.S.
increased 6.4% to €2,893 million driven by the strong sales
performance of Dupixent®, which more than offset lower General
Medicines sales.
In Europe sales decreased 5.6%
in the first quarter to €2,228 million reflecting lower sales of
General Medicines, CHC and Vaccines partly offset by Dupixent®,
Aubagio® and oncology sales growth.
In the Rest of the World, sales
increased 4.3% to €3,470 million in the first quarter driven mainly
by the strong performance of Lovenox®, Dupixent®, Vaccines,
Diabetes, and Rare Disease which more than offset lower CHC and
Rare Blood Disorders franchise sales. Sales in
China increased 8.4% to €726 million, driven by
Toujeo® and Dupixent® launches, as well as established Rx Products
and CHC performance. In Japan, first-quarter sales
decreased 8.7% to €434 million due to lower sales of Established Rx
Products and CHC.
R&D update at the end of the
first quarter 2021
Regulatory
update
-
The U.S. Food and Drug Administration (FDA) approved
Sarclisa® in combination with carfilzomib and
dexamethasone for patients with relapsed or refractory multiple
myeloma who have received one to three prior lines of therapy, and
the European Medicines Agency’s Committee for Medicinal Products
for Human Use (CHMP) adopted a positive opinion. Sarclisa® is
already approved in the U.S and Europe for use combination with
pomalidomide and dexamethasone for the treatment of adult patients
with relapsed and refractory multiple myeloma who have received at
least two prior therapies including lenalidomide and a proteasome
inhibitor.
-
The FDA approved Libtayo® monotherapy for patients
with first-line advanced non-small cell lung cancer with PD-L1
expression of >50%. These data were published in The Lancet
demonstrating superiority in extending overall survival (OS)
compared to chemotherapy even with a high crossover rate. The FDA
also approved Libtayo® as the first immunotherapy indicated for
patients with advanced basal cell carcinoma.
-
The European Commission approved Plavix® for use
in combination with aspirin in adult patients with moderate to
high-risk Transient Ischemic Attack (TIA) (ABCD2 score ≥4) or minor
Ischemic Stroke (IS) (NIHSS1 ≤3) within 24 hours of either the TIA
or IS event. Usage under this new indication can continue for 21
days, followed by long-term single anti-platelet therapy.
-
The FDA accepted Dupixent® for review in children
with moderate-to-severe asthma. The submission is supported by data
demonstrating Dupixent® significantly reduced severe asthma attacks
and is the only biologic to improve lung function in children aged
6 to 11 years in randomized Phase 3 trial, and further adds to the
well-established safety profile of Dupixent®. The target action
date for the FDA decision is October 21, 2021. Also, the European
Medicines Agency (EMA) has confirmed receipt of the submission for
Dupixent® in children with moderate-to-severe asthma.
-
Efanesoctocog alfa, formerly known as BIVV001, in
collaboration with Sobi and in development for hemophilia A was
granted Fast Track designation by the FDA.
-
SAR445136, formerly known as BIVV003, an ex-vivo
cell therapy developed in collaboration with Sangamo for the
treatment of sickle cell disease, was granted Fast Track
designation by the FDA. Also, the EMA’s Committee for Orphan
Medicinal Products (COMP) granted Orphan Drug Designation based on
early data from three patients that had 52 weeks, 13 weeks, and 29
days of follow-up, respectively.
Portfolio update
Phase 3:
-
The XTEND-Kids trial for efanesoctocog alfa
(formerly known as BIVV001) in pediatric patients with hemophilia A
enrolled its first patient.
-
The second pivotal trial to study itepekimab in
chronic obstructive pulmonary disease (COPD) (AERIFY-2) enrolled
its first patient.
-
An Independent Data Monitoring Committee (IDMC) recommended to stop
a Libtayo® Phase 3 trial in advanced cervical
cancer for positive results on OS. Patients with either squamous
cell carcinoma or adenocarcinoma recurrent or metastatic cervical
cancer were randomized to receive either Libtayo® monotherapy or an
investigator’s choice of commonly used chemotherapy.
-
Final results of Part A of the sutimlimab pivotal
Phase 3 CARDINAL open label, single-arm study evaluating the safety
and efficacy of sutimlimab for 26 weeks in people with cold
agglutinin disease were published in the New England Journal of
Medicine. Sutimlimab, a first-in-class investigational C1s
inhibitor, met the primary and secondary endpoints in the study and
demonstrated sustained inhibition of classical complement pathway
mediated hemolysis with improvements in anemia within one week of
treatment.
-
The amended protocol for all ongoing adult and adolescent
fitusiran clinical studies, aimed at further
enhancing the benefit-risk profile, was presented at the 14th
Annual Congress of the European Association for Haemophilia and
Allied Disorders (EAHAD). The dose for adults and adolescents will
be reduced to 50 mg every other month (six times a year), with the
potential to adjust the dose and/or dose frequency based on an
individual patient’s anti-thrombin levels. A re-start of dosing and
recruitment in the pediatric trial is expected later this
year.
Phase 2
-
CARMEN-LC05, a trial investigating tusamitamab
ravtansine, an anti-CEACAM5 antibody-drug conjugate (ADC),
in combination with pembrolizumab versus pembrolizumab alone in
patients with first-line non-squamous NSCLC started. Inclusion
criteria include expression of CEACAM5 as demonstrated
prospectively by a centrally assessed Immunohistochemistry (IHC)
assay of ≥2+ in intensity involving at least 50% of the tumor cell
population and PD-L1 positive tumor (TPS ≥1%). Patients with EGFR
sensitizing mutation or BRAF mutation or ALK/ROS alterations are
excluded.
-
Development for Dupixent® for grass allergy has
been discontinued.
-
SAR445088, a complement inhibitor formerly known
as BIVV020, has entered a study in adults with persistent/chronic
immune thrombocytopenia (ITP).
-
SAR441344, a CD40L antibody, has entered a study
for Sjogren’s Syndrome, an autoimmune condition that is most common
in older women and affects the tear and saliva glands.
-
A new study to select the most appropriate antigen dosage for Phase
3 evaluation of an adjuvanted recombinant protein COVID-19
vaccine candidate (SP0253) was initiated and already
completed enrollment. In parallel, development work has commenced
against emerging variants, which will be used to inform next stages
of the program. Trials results and the start of a global Phase 3
study are expected in Q2 2021. The trial program is supported by
the United States’ Biomedical Advanced Research and Development
Authority (BARDA).
-
MRT5500 (SP0254), an mRNA vaccine candidate
against SARS-CoV-2, entered Phase 1/2 to assess safety, immune
response and reactogenicity. Three different dose levels will be
investigated. Interim results are expected in Q3 2021. In parallel,
preclinical studies are underway to evaluate additional mRNA
candidates against emerging SARS-CoV-2 variants
-
SP0230, a novel multicomponent meningococcal Group
B Vaccine, in development for adults, adolescents, toddlers, and
infants started Phase 1/2.
Phase 1
-
SAR441566, a first, next generation, oral small
molecule TNF inhibitor that in contrast to anti-TNF biologics
blocks specifically the TNFR1 pathway, started Phase I in
inflammatory conditions.
-
SAR444656, an IRAK4 degrader being developed for
atopic dematitis in collaboration with Kymera also known as KT474,
started a Phase I trial in healthy volunteers. SAR444656 is the
first IRAK4 degrader to be studied outside of oncology.
-
Sanofi decided to not opt in on REGN4018,
REGN5459, or REGN5458. Sanofi no longer
has any non-compete obligations on refused candidates under the
amended and restated IO Discovery and Development agreement, which
terminated on March 16 2021.
-
Development of SAR441169, ROR gamma T antagonist
in collaboration with Lead Pharma, was terminated in
psoriasis.
-
SAR440234, T cell engaging multi specific
antibody, has been discontinued in leukemia.
An update of the R&D pipeline at as of March 31, 2021, is
available on our website:
https://www.sanofi.com/en/science-and-innovation/research-and-development
Collaborations
-
On January 12, 2021 Sanofi entered into a global licensing
agreement with Biond Biologics for BND-22, a novel
immune checkpoint inhibitor targeting the ILT2 receptor.
-
On February 23, 2021 Sanofi entered into a collaboration with
Sirion to innovate gene therapy treatment with
improved adeno-associated virus capsids.
Agreements related to COVID-19
vaccines
-
Sanofi will support manufacturing and supply of BioNTech’s mRNA
COVID-19 vaccine, co-developed with Pfizer, providing fill and
finish for over 125 million doses. Initial supplies will originate
from Sanofi’s production facilities in Frankfurt from summer of
2021.
-
Sanofi will support manufacturing of Janssen´s COVID-19 vaccine and
through its vaccine manufacturing plant in Marcy l’Etoile, France,
formulate and fill vials at a rate of approximately 12 million
doses per month.
Expanding affordable access to
those most in need
Sanofi has become a member of the top five
companies of the 2021 Access to Medicine index, recognizing its
work to make medicines accessible and available in low- and
middle-income countries. Sanofi has moved up two places in the
overall company ranking compared to its position in 2018,
performing particularly well in Research & Development (4th
place) and Product Delivery (3rd place). This recognition resonates
strongly with Sanofi’s Corporate Social Responsibility strategy.
Embedded in Sanofi’s long-term strategy, the company’s CSR
commitment is based on four pillars in which Sanofi is uniquely
positioned to make a difference: access to medicines, support for
vulnerable communities, preservation of the environment, and
inclusion and diversity of its employees.
On April 7, 2021, Sanofi announced a new
cornerstone of its CSR strategy, Sanofi Global Health, a newly
formed nonprofit unit within the company, dedicated to increasing
access to medicines considered essential by the World Health
Organization (WHO) for patients in the world’s 40 poorest
countries. Thirty of Sanofi's medicines will be provided across a
wide range of therapeutic areas, including cardiovascular disease,
diabetes, tuberculosis, malaria, and cancer. Sanofi Global Health
will also fund the training of healthcare professionals or the set
up and development of sustainable care systems for those who suffer
from chronic diseases and require complex care.Sanofi Global Health
is the first global initiative to provide access to such a broad
portfolio of medicines, in so many countries and across several
therapeutic areas, while funding local support programs.
Sanofi released its 2020 Integrated Report:
click here to start the experience.
2021 first-quarter financial
results
Business Net
Income4
In the first quarter of 2021, Sanofi generated
net sales of €8,591 million, a decrease of 4.3%
and an increase of 2.4% at CER.
First-quarter other revenues
decreased 14.0% (down 6.4% at CER) to €295 million, reflecting
lower VaxServe sales of non-Sanofi products (€228 million, down
12.9% at CER).
First-quarter Gross Profit
decreased 4.1% to €6,202 million (up 2.6% at CER). The gross margin
ratio increased 0.1 percentage points to 72.2% (72.3% at CER)
versus the first quarter of 2020. This increase mainly reflected
the improvement of the Pharmaceuticals gross margin ratio (from
74.9% to 75.2%) driven by growing weight of Specialty Care as well
as some efficiency gains in Industrial Affairs. Vaccines gross
margin ratio decreased 2.9 percentage point to 62.0% due to product
mix. CHC gross margin ratio improved from 67.7% to 68.0%.
Research and Development
(R&D) expenses decreased 5.5% to €1,266 million in the first
quarter. At CER, R&D expenses decreased 1.7% reflecting
significant increase in key assets development offset by
operational efficiencies and lower costs on mature projects. In the
first quarter, the ratio of R&D to sales decreased 0.2
percentage point to 14.7% compared to the prior year.
First-quarter selling general and
administrative expenses (SG&A) decreased 6.3% to
€2,194 million. At CER, SG&A expenses were down 0.7%,
reflecting increased investments in Specialty Care and Vaccines
which were more than offset by smart spending and operational
excellence initiatives. In the first quarter, the ratio of SG&A
to sales decreased 0.6 percentage point to 25.5% compared to the
prior year.
First-quarter operating
expenses were €3,460 million, a decrease of 6.0% and 1.1%
at CER.
First-quarter other current operating
income net of expenses was -€101 million versus -€247
million in the prior year and included a €119 million payment from
Daiichi Sankyo related to the termination of a vaccines
collaboration in Japan. This line included an expense of €279
million (versus an expense of €243 million in the first 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.
The share of profit from
associates was stable at €9 million. Following the sale of
its Regeneron stake at the end of May 2020, Sanofi restated its
previously reported non-GAAP indicator (Business Net Income) and
excluded the effect of equity method of accounting for Regeneron
investment in 2019, Q1 2020 and Q2 2020.
First-quarter business operating
income4 (BOI) increased 4.0% to €2,638 million. At CER,
BOI increased 13.3% and 8.4% excluding the payment from Daiichi
Sankyo. The ratio of BOI to net sales increased 2.4 percentage
points to 30.7% (and to 29.3% excluding the payment from Daiichi
sankyo) versus the prior year.
Net financial expenses were €85
million in the first quarter versus €75 million in the same period
of 2020.
First-quarter 2021 effective tax
rate was 21.0% versus 22% in the first quarter of 2020.
Sanofi expects its effective tax rate to be around 21% in 2021,
everything being equal in the U.S.
First-quarter business net
income4 increased 5.1% to €2,017 million and increased
14.7% at CER. The ratio of business net income to net sales
increased 2.1 percentage points to 23.5% (and 1 percentage point
excluding the payment from Daiichi Sankyo) versus the first quarter
of 2020.
In the first quarter of 2021, business
earnings per share4 (EPS) was €1.61, up 5.2% on a reported
basis and up 15.0% at CER (up 9.8% at CER excluding the payment
from Daiichi Sankyo). The average number of shares outstanding was
1,249.3 million versus 1,251.3 million in first quarter 2020.
Reconciliation of IFRS net
income reported to business net income (see Appendix
4)
In the first quarter of 2021, the IFRS net
income was €1,566 million. The main items excluded from the
business net income were:
- An amortization
charge of €389 million related to fair value remeasurement on
intangible assets of acquired companies (primarily Genzyme: €126
million, Bioverativ: €79 million, Boehringer Ingelheim CHC
business: €50 million and Ablynx: €42 million) and to acquired
intangible assets (licenses/products: €23 million). These items
have no cash impact on the Company.
- Restructuring costs
and similar items of €156 million related to streamlining
initiatives.
- A €132 million tax
effect arising from the items listed above, mainly comprising €89
million of deferred taxes generated by amortization and impairments
of intangible assets and €42 million associated with restructuring
costs and similar items (see Appendix 4).
Capital
Allocation
In the first quarter of 2021, free cash flow5
increased by 23.6% to €1,925 million, after net changes in working
capital (+€422 million), capital expenditures (-€378 million) and
other asset acquisitions6 (-€277 million), proceeds from disposals4
(€82 million), and payments related to restructuring and similar
items (-€244 million). As a consequence, net debt decreased from
€8,789 million at December 31, 2020 to €6,823 million at March 31,
2021 (amount net of €13,948 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, 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 first-quarter
sales by GBU, franchise, geographic region and product |
Appendix 2: |
2021 first-quarter
business net income statement |
Appendix 3: |
2021 first-quarter
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 first-quarter
net sales by GBU, franchise, geographic region and
product
Q1 2021
(€ million) |
Total Sales |
% CER |
% reported |
|
United States |
% CER |
|
Europe |
% CER |
|
Rest of the world |
% CER |
Dupixent |
1,047 |
45.6 |
% |
34.9 |
% |
|
793 |
41.6 |
% |
|
137 |
52.2 |
% |
|
117 |
71.2 |
% |
Aubagio |
500 |
-1.1 |
% |
-7.6 |
% |
|
339 |
-5.1 |
% |
|
132 |
12.7 |
% |
|
29 |
-3.1 |
% |
Lemtrada |
24 |
-44.9 |
% |
-51.0 |
% |
|
10 |
-52.2 |
% |
|
5 |
-61.5 |
% |
|
9 |
-15.4 |
% |
Kevzara |
57 |
10.9 |
% |
3.6 |
% |
|
25 |
-15.6 |
% |
|
21 |
5.0 |
% |
|
11 |
333.3 |
% |
Neurology & Immunology |
581 |
-3.4 |
% |
-9.9 |
% |
|
374 |
-8.3 |
% |
|
158 |
5.3 |
% |
|
49 |
14.6 |
% |
Cerezyme |
178 |
4.2 |
% |
-5.8 |
% |
|
40 |
-6.5 |
% |
|
63 |
-4.5 |
% |
|
75 |
18.4 |
% |
Cerdelga |
62 |
13.8 |
% |
6.9 |
% |
|
32 |
12.9 |
% |
|
26 |
8.3 |
% |
|
4 |
66.7 |
% |
Myozyme |
235 |
0.8 |
% |
-4.5 |
% |
|
88 |
11.5 |
% |
|
98 |
-4.8 |
% |
|
49 |
-5.5 |
% |
Fabrazyme |
208 |
4.7 |
% |
-2.8 |
% |
|
93 |
-2.9 |
% |
|
57 |
9.6 |
% |
|
58 |
13.8 |
% |
Aldurazyme |
66 |
7.5 |
% |
-1.5 |
% |
|
12 |
8.3 |
% |
|
23 |
9.5 |
% |
|
31 |
5.9 |
% |
Rare Disease |
770 |
4.4 |
% |
-3.0 |
% |
|
265 |
3.2 |
% |
|
267 |
0.4 |
% |
|
238 |
10.2 |
% |
Jevtana |
126 |
-2.9 |
% |
-8.7 |
% |
|
58 |
5.0 |
% |
|
45 |
-11.8 |
% |
|
23 |
-3.7 |
% |
Fasturtec |
35 |
8.6 |
% |
0.0 |
% |
|
21 |
4.5 |
% |
|
11 |
10.0 |
% |
|
3 |
33.3 |
% |
Libtayo |
26 |
125.0 |
% |
116.7 |
% |
|
— |
0.0 |
% |
|
22 |
120.0 |
% |
|
4 |
150.0 |
% |
Sarclisa |
34 |
3400.0 |
% |
3300.0 |
% |
|
12 |
1200.0 |
% |
|
13 |
0.0 |
% |
|
9 |
0.0 |
% |
Oncology |
221 |
25.8 |
% |
18.8 |
% |
|
91 |
19.3 |
% |
|
91 |
28.2 |
% |
|
39 |
37.5 |
% |
Alprolix |
100 |
-1.8 |
% |
-8.3 |
% |
|
79 |
3.6 |
% |
|
— |
0.0 |
% |
|
21 |
-19.2 |
% |
Eloctate |
134 |
-9.9 |
% |
-16.8 |
% |
|
103 |
-5.0 |
% |
|
— |
0.0 |
% |
|
31 |
-23.8 |
% |
Cablivi |
38 |
66.7 |
% |
58.3 |
% |
|
22 |
60.0 |
% |
|
15 |
66.7 |
% |
|
1 |
0.0 |
% |
Rare Blood Disorder |
272 |
-0.7 |
% |
-7.5 |
% |
|
204 |
2.8 |
% |
|
15 |
66.7 |
% |
|
53 |
-20.6 |
% |
Specialty Care |
2,891 |
15.3 |
% |
7.3 |
% |
|
1,727 |
15.2 |
% |
|
668 |
13.9 |
% |
|
496 |
17.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Lantus |
652 |
-3.7 |
% |
-9.9 |
% |
|
192 |
-8.7 |
% |
|
125 |
-16.1 |
% |
|
335 |
4.9 |
% |
Toujeo |
253 |
5.1 |
% |
-1.6 |
% |
|
62 |
0.0 |
% |
|
94 |
-5.0 |
% |
|
97 |
20.2 |
% |
Soliqua/iGlarLixi |
44 |
29.7 |
% |
18.9 |
% |
|
26 |
27.3 |
% |
|
7 |
16.7 |
% |
|
11 |
44.4 |
% |
0thers Diabetes |
226 |
-7.3 |
% |
-13.7 |
% |
|
44 |
-11.1 |
% |
|
64 |
-7.1 |
% |
|
118 |
-5.8 |
% |
Diabetes |
1,175 |
-1.7 |
% |
-8.2 |
% |
|
324 |
-5.3 |
% |
|
290 |
-10.2 |
% |
|
561 |
5.3 |
% |
Lovenox |
401 |
30.4 |
% |
21.9 |
% |
|
13 |
75.0 |
% |
|
186 |
10.5 |
% |
|
202 |
50.7 |
% |
Plavix |
251 |
-4.0 |
% |
-8.1 |
% |
|
2 |
0.0 |
% |
|
29 |
-23.7 |
% |
|
220 |
-2.1 |
% |
Multaq |
72 |
-3.7 |
% |
-11.1 |
% |
|
62 |
-4.2 |
% |
|
6 |
0.0 |
% |
|
4 |
0.0 |
% |
Praluent |
56 |
-20.5 |
% |
-23.3 |
% |
|
5 |
-81.3 |
% |
|
36 |
20.0 |
% |
|
15 |
45.5 |
% |
Aprovel |
101 |
-39.7 |
% |
-42.0 |
% |
|
2 |
-60.0 |
% |
|
23 |
-23.3 |
% |
|
76 |
-42.4 |
% |
Mozobil |
52 |
1.9 |
% |
-3.7 |
% |
|
28 |
-6.3 |
% |
|
14 |
0.0 |
% |
|
10 |
37.5 |
% |
Thymoglobulin |
80 |
1.2 |
% |
-5.9 |
% |
|
46 |
0.0 |
% |
|
8 |
-11.1 |
% |
|
26 |
8.0 |
% |
Generics |
206 |
3.5 |
% |
-10.8 |
% |
|
29 |
-13.5 |
% |
|
2 |
0.0 |
% |
|
175 |
6.8 |
% |
Others |
1,090 |
-12.2 |
% |
-16.7 |
% |
|
76 |
-31.4 |
% |
|
349 |
-21.6 |
% |
|
665 |
-3.3 |
% |
Cardiovascular & Established Rx Products |
2,309 |
-5.6 |
% |
-11.5 |
% |
|
263 |
-19.0 |
% |
|
653 |
-12.0 |
% |
|
1,393 |
0.7 |
% |
Industrial Sales |
188 |
8.8 |
% |
3.9 |
% |
|
11 |
9.1 |
% |
|
156 |
9.0 |
% |
|
21 |
8.0 |
% |
General Medicines |
3,672 |
-3.8 |
% |
-9.8 |
% |
|
598 |
-11.7 |
% |
|
1,099 |
-9.0 |
% |
|
1,975 |
2.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals |
6,563 |
3.8 |
% |
-3.0 |
% |
|
2,325 |
6.8 |
% |
|
1,767 |
-1.5 |
% |
|
2,471 |
4.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
533 |
14.9 |
% |
10.1 |
% |
|
135 |
40.4 |
% |
|
78 |
6.8 |
% |
|
320 |
8.2 |
% |
Adult Booster Vaccines |
100 |
-8.7 |
% |
-13.0 |
% |
|
48 |
-3.7 |
% |
|
34 |
-26.1 |
% |
|
18 |
26.7 |
% |
Meningitis / Pneumonia |
128 |
3.8 |
% |
-2.3 |
% |
|
76 |
3.8 |
% |
|
— |
0.0 |
% |
|
52 |
3.9 |
% |
Influenza Vaccines |
77 |
23.8 |
% |
22.2 |
% |
|
— |
-100.0 |
% |
|
9 |
300.0 |
% |
|
68 |
45.8 |
% |
Travel and Other Endemic Vaccines |
59 |
-37.4 |
% |
-40.4 |
% |
|
14 |
-37.5 |
% |
|
5 |
-83.9 |
% |
|
40 |
-4.5 |
% |
Vaccines |
915 |
5.3 |
% |
0.7 |
% |
|
285 |
7.6 |
% |
|
127 |
-16.3 |
% |
|
503 |
10.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy |
195 |
-6.2 |
% |
-13.3 |
% |
|
106 |
3.6 |
% |
|
18 |
0.0 |
% |
|
71 |
-18.9 |
% |
Cough, Cold and Flu |
55 |
-59.4 |
% |
-61.5 |
% |
|
— |
0.0 |
% |
|
25 |
-67.5 |
% |
|
30 |
-50.0 |
% |
Pain Care |
253 |
-11.6 |
% |
-18.6 |
% |
|
40 |
-13.7 |
% |
|
122 |
-14.5 |
% |
|
91 |
-7.0 |
% |
Digestive Wellness |
283 |
14.6 |
% |
5.6 |
% |
|
25 |
22.7 |
% |
|
105 |
0.0 |
% |
|
153 |
24.5 |
% |
Physical Wellness |
81 |
2.3 |
% |
-5.8 |
% |
|
— |
0.0 |
% |
|
8 |
14.3 |
% |
|
73 |
1.3 |
% |
Mental Wellness |
53 |
18.8 |
% |
10.4 |
% |
|
11 |
9.1 |
% |
|
29 |
15.4 |
% |
|
13 |
36.4 |
% |
Personal Care |
125 |
2.2 |
% |
-6.7 |
% |
|
96 |
1.9 |
% |
|
1 |
0.0 |
% |
|
28 |
3.3 |
% |
Non-Core / Others |
68 |
-15.3 |
% |
-20.0 |
% |
|
5 |
66.7 |
% |
|
26 |
-33.3 |
% |
|
37 |
-4.7 |
% |
Consumer Healthcare |
1,113 |
-7.3 |
% |
-14.4 |
% |
|
283 |
2.3 |
% |
|
334 |
-19.3 |
% |
|
496 |
-3.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
8,591 |
2.4 |
% |
-4.3 |
% |
|
2,893 |
6.4 |
% |
|
2,228 |
-5.6 |
% |
|
3,470 |
4.3 |
% |
Appendix 2: Business net income
statement
First Quarter 2021 |
Pharmaceuticals |
Vaccines |
Consumer Healthcare |
Others(1) |
Total Group |
€
million |
Q1 2021 |
Q1 2020 |
Change |
Q1 2021 |
Q1 2020 |
Change |
Q1 2021 |
Q1 2020 |
Change |
Q1 2021 |
Q1 2020 |
Change |
Q1 2021 |
Q1 2020 |
Change |
Net
sales |
6,563 |
6,764 |
-3.0% |
915 |
909 |
0.7% |
1,113 |
1,300 |
-14.4% |
— |
— |
—% |
8,591 |
8,973 |
-4.3% |
Other
revenues |
50 |
40 |
25.0% |
231 |
288 |
-19.8% |
14 |
15 |
-6.7% |
— |
— |
—% |
295 |
343 |
-14.0% |
Cost of
Sales |
(1,679) |
(1,736) |
-3.3% |
(579) |
(607) |
-4.6% |
(370) |
(435) |
-14.9% |
(56) |
(69) |
-18.8% |
(2,684) |
(2,847) |
-5.7% |
As % of net
sales |
(25.6)% |
(25.7)% |
|
(63.3)% |
(66.8)% |
|
(33.2)% |
(33.5)% |
|
|
|
|
(31.2)% |
(31.7)% |
|
Gross
Profit |
4,934 |
5,068 |
-2.6% |
567 |
590 |
-3.9% |
757 |
880 |
-14.0% |
(56) |
(69) |
-18.8% |
6,202 |
6,469 |
-4.1% |
As % of
net sales |
75.2% |
74.9% |
|
62.0% |
64.9% |
|
68.0% |
67.7% |
|
|
|
|
72.2% |
72.1% |
|
Research and
development expenses |
(978) |
(1,031) |
-5.1% |
(145) |
(155) |
-6.5% |
(28) |
(32) |
-12.5% |
(115) |
(122) |
-5.7% |
(1,266) |
(1,340) |
-5.5% |
As % of net
sales |
(14.9)% |
(15.2)% |
|
(15.8)% |
(17.1)% |
|
(2.5)% |
(2.5)% |
|
|
|
|
(14.7)% |
(14.9)% |
|
Selling and
general expenses |
(1,188) |
(1,209) |
-1.7% |
(170) |
(180) |
-5.6% |
(344) |
(384) |
-10.4% |
(492) |
(569) |
-13.5% |
(2,194) |
(2,342) |
-6.3% |
As % of net
sales |
(18.1)% |
(17.9)% |
|
(18.6)% |
(19.8)% |
|
(30.9)% |
(29.5)% |
|
|
|
|
(25.5)% |
(26.1)% |
|
Other current
operating income/expenses |
(252) |
(191) |
|
120 |
3 |
|
10 |
23 |
|
21 |
(82) |
|
(101) |
(247) |
|
Share of
profit/loss of associates* and joint ventures (2) |
7 |
8 |
|
(1) |
1 |
|
3 |
— |
|
— |
— |
|
9 |
9 |
|
Net income
attributable to non controlling interests |
(8) |
(8) |
|
— |
— |
|
(4) |
(4) |
|
— |
— |
|
(12) |
(12) |
|
Business
operating income (3) |
2,515 |
2,637 |
-4.6% |
371 |
259 |
43.2% |
394 |
483 |
-18.4% |
(642) |
(842) |
-23.8% |
2,638 |
2,537 |
4.0% |
As % of
net sales |
38.3% |
39.0% |
|
40.5% |
28.5% |
|
35.4% |
37.2% |
|
|
|
|
30.7% |
28.3% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income and expenses |
(85) |
(75) |
|
|
|
|
|
Income tax expenses |
|
|
|
|
(536) |
(542) |
|
|
|
|
|
Tax
rate** |
|
|
|
|
21.0% |
22.0% |
|
|
|
|
|
Business net income |
|
|
|
|
2,017 |
1,920 |
5.1% |
|
|
|
|
As % of net sales |
|
|
|
|
23.5% |
21.4% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business earnings / share(in euros)*** |
1.61 |
1.53 |
5.2% |
* 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 1,249.3 million in the first
quarter of 2021 and 1,251.3 million in the first quarter of
2020. (1) Other
includes the cost of global support functions (Finance, Human
Resources, Information Solution & Technologies, Sanofi Business
Services, etc…).(2) The line "Share of profits of
associates and joint-ventures " has been restated in Q1 2020 to
exclude any effect of equity method accounting for Regeneron
investment 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.(3) In 2020,
reclassification of certain costs from the business segments to the
segment "Others"
Appendix 3: Consolidated income
statements
€
million |
Q1 2021 |
Q1 2020 |
Net
sales |
8,591 |
|
8,973 |
|
Other revenues |
295 |
|
343 |
|
Cost of sales |
(2,684) |
|
(2,865) |
|
Gross
profit |
6,202 |
|
6,451 |
|
Research and development expenses |
(1,266) |
|
(1,340) |
|
Selling and general expenses |
(2,194) |
|
(2,342) |
|
Other operating income |
267 |
|
108 |
|
Other operating expenses |
(368) |
|
(355) |
|
Amortization of intangible assets |
(389) |
|
(457) |
|
Impairment of intangible assets (1) |
(2) |
|
(85) |
|
Fair value remeasurement of contingent consideration |
(36) |
|
12 |
|
Restructuring costs and similar items |
(156) |
|
(66) |
|
Other gains and losses, and litigation (2) |
— |
|
120 |
|
Operating income |
2,058 |
|
2,046 |
|
Financial expenses |
(99) |
|
(98) |
|
Financial income |
14 |
|
23 |
|
Income
before tax and associates and joint ventures |
1,973 |
|
1,971 |
|
Income tax expense |
(404) |
|
(434) |
|
Share of profit/(loss) of associates and joint ventures |
9 |
|
158 |
|
Net
income |
1,578 |
|
1,695 |
|
Net income attributable to non-controlling interests |
12 |
|
12 |
|
Net
income attributable to equity holders of Sanofi |
1,566 |
|
1,683 |
|
Average number
of shares outstanding (million) |
1,249.3 |
|
1,251.3 |
|
IFRS Earnings per share (in euros) |
1.25 |
|
1.35 |
|
(1) In 2020, mainly related to the termination
of several Diabetes R&D programs and collaborations agreements
as part of Group Strategy announced in December
2019(2) In 2020, includes mainly the gain on the
sale of operations related to the Seprafilm product to Baxter.
Appendix 4: Reconciliation of Net income
attributable to equity holders of Sanofi to Business net
income
€
million |
Q1 2021 |
Q1 2020 |
Net
income attributable to equity holders of Sanofi |
1,566 |
|
1,683 |
|
Amortization of
intangible assets (1) |
389 |
|
457 |
|
Impairment of
intangible assets (2) |
2 |
|
85 |
|
Fair value
remeasurement of contingent consideration |
36 |
|
(12) |
|
Expenses arising
from the impact of acquisitions on inventories |
— |
|
18 |
|
Restructuring
costs and similar items |
156 |
|
66 |
|
Other gains and
losses, and litigation (3) |
— |
|
(120) |
|
Tax effect of
the items listed above: |
(132) |
|
(108) |
|
Amortization and impairment of intangible assets |
(89) |
|
(125) |
|
Fair value remeasurement of contingent consideration |
(1) |
|
(22) |
|
Expenses arising from the impact of acquisitions on
inventories |
— |
|
(3) |
|
Restructuring costs and similar items |
(42) |
|
(20) |
|
Other tax effects |
— |
|
62 |
|
Restructuring
costs of associates and joint ventures, and expenses arising from
the impact of acquisitions on associates and joint ventures |
— |
|
(27) |
|
Effect of
discontinuation of use of equity method for Regeneron investment
(4) |
— |
|
(122) |
|
Business
net income |
2,017 |
|
1,920 |
|
IFRS earnings per share (5)
(in euros) |
1.25 |
|
1.35 |
|
(1) Of which related to amortization expense
generated by the remeasurement of intangible assets as part of
business combinations: €366 million in the first quarter of 2021
and €435 million in the first quarter of 2020.
(2) In 2020, mainly related to the termination
of several Diabetes R&D programs and collaborations agreements
as part of Group Strategy announced in December 2019
(3) In 2020, includes mainly the gain on the
sale of operations related to the Seprafilm product to Baxter.
(4) 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.
(5) Q1: Based on an average number of shares
outstanding of 1,249.3 million in the first quarter of 2021 and
1,251.3 million in the first quarter of 2020.
Appendix 5: Change in net
debt
€
million |
Q1 2021 |
Q1 2020 |
(1) |
Business
net income |
2,017 |
|
1,920 |
|
|
Depreciation
& amortization & impairment of property, plant and
equipment and software |
347 |
|
367 |
|
|
Other non-cash
items |
(44) |
|
(2) |
|
|
Operating cash flow before change in working
capital |
2,320 |
|
2,285 |
|
|
Changes in
Working Capital |
422 |
|
(414) |
|
|
Acquisitions of
property, plant and equipment and software |
(378) |
|
(319) |
|
|
Free
cash flow before restructuring, acquisitions and
disposals |
2,364 |
|
1,552 |
|
|
Acquisitions of
intangibles assets, investments and other long-term financial
assets (2) |
(277) |
|
(165) |
|
|
Restructuring
costs and similar items paid |
(244) |
|
(277) |
|
|
Proceeds from
disposals of property, plant and equipment, intangible assets and
other non-current assets net of taxes (2) |
82 |
|
448 |
|
|
Free
cash flow |
1,925 |
|
1,558 |
|
|
Acquisitions of
investments in consolidated undertakings includingassumed debt
(3) |
(21) |
|
(2,245) |
|
|
Issuance of
Sanofi shares |
11 |
|
32 |
|
|
Acquisition of
treasury shares |
(140) |
|
(361) |
|
|
Other items |
191 |
|
(68) |
|
|
Change in net debt |
1,966 |
|
(1,084) |
|
|
Beginning of period |
8,789 |
|
15,107 |
|
|
Closing of net debt |
6,823 |
|
16,191 |
|
|
(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 Q1 2021 sales
Currency |
Q1 2021 |
US $ |
34.6 |
% |
Euro € |
22.5 |
% |
Chinese
Yuan |
8.0 |
% |
Japanese
Yen |
5.1 |
% |
Brazilian
Real |
2.5 |
% |
Russian
Ruble |
1.7 |
% |
Canadian $ |
1.6 |
% |
British
Pound |
1.4 |
% |
Mexican
Peso |
1.4 |
% |
India Rupee |
1.4 |
% |
Others |
19.8 |
% |
Currency average rates
|
Q1 2020 |
Q1 2021 |
Change |
€/$ |
1.10 |
|
1.21 |
|
+9.4% |
€/Yen |
120.15 |
|
127.69 |
|
+6.3% |
€/Yuan |
7.71 |
|
7.81 |
|
+1.3% |
€/Real |
4.91 |
|
6.59 |
+34.2% |
€/Ruble |
73.67 |
|
89.72 |
|
+21.8% |
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 first quarter
2021
€
million |
Q1 2021 |
Net
sales |
8,591 |
|
Effect of exchange
rates |
(595) |
|
Company sales at constant exchange rates |
9,186 |
|
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. in market U.S. sales
in Q1 2020 and U.S. sales to Regeneron in Q1 20214 See Appendix 3
for 2021 first-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.5 non-GAAP financial measure (definition in Appendix
7).6 Not exceeding €500 million per transaction (inclusive of
all payments related to the transaction).
Attachment
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