Press Release: Sanofi continues to deliver strong business EPS
growth driven by higher sales and improved margins in Q1
Sanofi continues to deliver strong business EPS(1) growth driven
by higher sales and improved margins in Q1
Paris, April 28, 2022
Q1 2022 sales growth of 8.6% at CER driven by
Dupixent® and CHC
- Specialty Care grew 17.8% driven by
Dupixent® (€1,614 million, +45.7%)
- Vaccines were up 6.8% reflecting
strong PPH franchise as well as gradual recovery of Travel
vaccines
- General Medicines core assets up
4.7% driven by Rezurock® and overall GBU sales broadly stable
(-0.7%)
- CHC continued
strong growth momentum (+17.0%) driven by Cough & Cold and Pain
care categories
Q1 2022 business
EPS(1)
up 16.1% at CER driven by higher sales and improving
margins
- BOI margin reached 31.7% up 1.0 ppt
reflecting improvement in gross margin while investing in
R&D
- Business EPS(1) of €1.94, up 20.5%
on a reported basis and 16.1% at CER, also benefitting from an
improved effective tax rate
- IFRS EPS of €1.61 (up 28.8%)
Progress on Corporate Social Responsibility
strategy
- Sanofi continues its progress to
improve access to medicines; issuing a sustainability-linked bond
and publishing its global access and pricing policy
- Sanofi is working with experts from
leading oncology institutions to reach its CSR ambitions on
childhood cancer
Key milestone and regulatory achievements on R&D
transformation
- Efanesoctocog alfa met phase 3
primary endpoint in hemophilia A and demonstrated superiority to
prior factor prophylaxis
- Dupixent® approved in EU for severe
asthma in children aged 6 to 11 years; Priority Review obtained in
atopic dermatitis for children (6 months to 5 years) and
eosinophilic esophagitis patients 12 years and older in the
U.S.
- Nirsevimab EMA regulatory
submission accepted under accelerated assessment for RSV protection
in all infants
- FDA approved Enjaymo™, first
treatment for use in patients with cold agglutinin disease
(CAD)
- Xenpozyme® approved in Japan, first
and only approved therapy indicated to treat acid sphingomyelinase
deficiency (ASMD)
- Sanofi and GSK applied for
conditional regulatory authorization for their first-generation
COVID-19 vaccine in Europe with data supporting its use as a
universal booster, designed to boost all currently approved
COVID-19 vaccine platforms
2022 financial outlook
- Sanofi expects
2022 business EPS(1) to grow low double-digit(2) at CER, barring
unforeseen major adverse events. Applying average April 2022
exchange rates, the positive currency impact on 2022 business EPS
is estimated to be between +4% to +5%
Sanofi Chief Executive Officer, Paul Hudson,
commented:
“We are off to a strong start to 2022 propelled
by the continued outstanding performance of Dupixent®, double-digit
growth of our CHC business and improved margins in the first
quarter. In R&D, we increased our investments to fuel our
rapidly advancing pipeline which was further enhanced through BD
collaborations such as Seagen, IGM, Exscientia and Blackstone
during the period. As highlighted at our investor event in March,
we remain focused on our path to industry leadership in Immunology
with a broad set of novel treatments in development, including
additional indications for Dupixent® in diseases such as Prurigo
Nodularis and Eosinophilic Esophagitis which were recently
submitted for regulatory approval. In addition, we are particularly
excited about the positive pivotal trial readout for efanesoctogog
alfa, our potentially revolutionizing treatment for Hemophilia A
patients, with its filing planned for mid-year. Also in the
quarter, we continued to execute well against our strategic
priorities with our decision for the proposed EUROAPI shares
listing and spin-off through an extraordinary dividend. Based on
the strong first quarter, we are on track to deliver on our 2022
financial guidance, despite the challenging business
environment.“
|
Q1 2022 |
Change |
Change at CER |
IFRS net sales reported |
€9,674m |
+12.6% |
+8.6% |
IFRS net income reported |
€2,009m |
+28.3% |
_ |
IFRS
EPS reported |
€1.61 |
+28.8% |
_ |
Free cash flow(3) |
€1,707m |
-11.3% |
_ |
Business operating income |
€3,065m |
+16.2% |
+12.2% |
Business net income(1) |
€2,424m |
+20.2% |
+16.0% |
Business EPS(1) |
€1.94 |
+20.5% |
+16.1% |
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 2022 is provided in Appendix 3 and a reconciliation of reported
IFRS net income to business net income is set forth in Appendix 4;
(2) 2021 business EPS was €6.56; (3) Free cash flow is a non-GAAP
financial measure (definition in Appendix 7).
2022 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 2022, Sanofi sales were
€9,674 million, up 12.6% on a reported basis. Exchange rate
movements had a positive effect of 4.0 percentage points, mainly
due to the U.S. dollar. At CER, company sales were up 8.6%.
Global Business Units
First-quarter 2022 operating
income
First-quarter business operating
income (BOI) increased 16.2% to €3,065 million. At CER,
BOI increased 12.2%. The ratio of BOI to net sales increased 1.0
percentage point to 31.7% (31.7% at CER).
Pharmaceuticals
First-quarter 2022 Pharmaceutical sales
increased 7.5% to €7,326 million, mainly driven by the Specialty
Care portfolio (up 17.8%) with continued strong performance of
Dupixent® while sales in General Medicines decreased 0.7%.
Specialty Care
Dupixent
Net sales (€ million) |
Q1 2022 |
Change at CER |
Total
Dupixent® |
1,614 |
+45.7% |
In the first quarter, Dupixent® (collaboration
with Regeneron) sales increased 45.7% to €1,614 million. In the
U.S., Dupixent® sales of €1,176 million (up 38.1%) were driven by
continued strong demand in 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 43% (year-over-year) and new-to-brand
prescriptions (NBRx) grew 32%. In Europe, first-quarter Dupixent®
sales grew 53.3% to €211 million reflecting continued growth in AD
and additional launches in younger population in AD, asthma and
CRSwNP.
Neurology and Immunology
Net sales (€ million) |
Q1 2022 |
Change at CER |
Aubagio® |
491 |
-6.6% |
Lemtrada® |
25 |
—% |
Kevzara® |
95 |
+61.4% |
Total Neurology and Immunology |
611 |
+0.3% |
In the first quarter, Neurology and
Immunology sales grew 0.3% to €611 million, reflecting
strong Kevzara® sales which were partially offset by lower Aubagio®
sales.
Aubagio® sales decreased 6.6%
in the first quarter to €491 million due to lower sales in the U.S.
as a result of both competitive pressure and price. Sales in Europe
were stable.
First-quarter Kevzara®
(collaboration with Regeneron) sales increased 61.4% to €95 million
due to a COVID-19 related increase in global demand for IL-6
receptor blockers and the temporary tocilizumab shortage.
Rare Disease
Net sales (€ million) |
Q1 2022 |
Change at CER |
Myozyme® / Lumizyme® |
235 |
-3.0% |
Nexviazyme® |
30 |
ns |
Fabrazyme® |
22 |
+2.4% |
Cerezyme® |
165 |
-6.7% |
Aldurazyme® |
69 |
+3.0% |
Cerdelga® |
67 |
+3.2% |
Others
Rare Disease |
18 |
-14.3% |
Total Rare Disease |
804 |
+1.9% |
In the first quarter, Rare
Disease sales increased 1.9% to €804 million driven by the
Pompe franchise, partially offset by unfavorable purchasing
patterns in Rest of the World region primarily for the Gaucher and
Fabrazyme franchises. Underlying patients base treated grew around
6% compared to the same quarter of last year.
First-quarter sales of the
Pompe franchise
(Myozyme/Lumizyme® + Nexviazyme®) increased 8.9% to €265 million
primarily from new patient accruals and the ramp up of Nexviazyme®.
Myozyme®/Lumizyme®
sales decreased 3.0% to €235 million mainly reflecting the
conversion to Nexviazyme® in the U.S. Sales of
Nexviazyme® (which was launched
in the US in August 2021 and in Japan in November 2021) were €30
million in the first quarter (of which €26 million in the
U.S.).
Sales of the Gaucher franchise
(Cerezyme® + Cerdelga®) decreased 4.2% (to €232 million) in the
first quarter. Over the period, Cerezyme® sales
decreased 6.7% to €165 million, mainly due to unfavorable buying
patterns resulting in lower sales in the Rest of the World region.
In parallel, Cerdelga® sales were up 3.2% driven
by switches and new patient accruals in Europe and the U.S.
First-quarter Fabrazyme® sales
increased 2.4% to €220 million driven mainly by Europe and the U.S.
In the Rest of the World region, despite unfavorable purchasing
patterns, Fabrazyme® sales were stable.
Oncology
Net sales (€ million) |
Q1 2022 |
Change at CER |
Jevtana® |
98 |
-25.4% |
Sarclisa® |
65 |
+85.3% |
Fasturtec® |
40 |
+8.6% |
Libtayo® |
41 |
+53.8% |
Total Oncology |
244 |
+6.8% |
First-quarter 2022 sales of
Oncology increased 6.8% (to €244 million) driven
by the Sarclisa® launch which more than offset the impact of
Jevtana® generic competition in Europe.
First-quarter Jevtana® sales
decreased 25.4% to €98 million following the entry of generic
competition in some European markets (down 75.6%) at the end of
March 2021. In the U.S., sales were up 8.6%, where Jevtana® is
currently covered by four Orange Book listed patents US 7,241,907,
US 8,927,592, US 10,583,110 and US 10,716,777. Sanofi filed patent
infringement suits under Hatch-Waxman against generic filers
asserting the ‘110 patent, the ‘777 patent and the '592 patent in
the US District Court for the District of Delaware. Sanofi has
reached settlement agreements with some of the defendants and the
suit against the remaining defendants is ongoing. A 3-day trial
against Apotex and Sandoz has been scheduled starting January 2023
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. Jevtana® also received a regulatory data
exclusivity related to the CARD clinical study which expires in
December 2023.
First-quarter Sarclisa® sales
were €65 million (versus €34 million in the first quarter of 2021)
primarily driven by performance in the U.S. (€25 million), Europe
(€22 million) and Japan.
Rare Blood Disorders
Net sales (€ million) |
Q1 2022 |
Change at CER |
Eloctate® |
138 |
-3.0% |
Alprolix® |
108 |
+2.0% |
Cablivi® |
46 |
+15.8% |
Total Rare Blood Disorders |
293 |
+1.8% |
In the first quarter, Rare Blood
Disorders franchise sales increased 1.8% (€293 million),
reflecting Cablivi® and Alprolix® growth partially offset by lower
Eloctate®/Alprolix® industrial sales to Sobi (recorded in the Rest
of the World region).
Eloctate® sales were €138
million in the first quarter, down 3.0% reflecting lower sales in
the U.S. (down 1.9%) and in the Rest of the World region.
First-quarter Alprolix® sales
were up 2.0% to €108 million driven by the U.S. sales (up 8.9%),
partially offset by lower sales in the Rest of the World
region.
Cablivi® sales increased by
15.8% to €46 million in the first quarter driven by launches in
Europe (up 46.7% to €23 million). In the U.S., sales of the product
were down 4.5% to €22 million, due to the COVID-19 environment
impacting treatment initiations at the hospital level.
General Medicines
First quarter General Medicines sales decreased
0.7% to €3,760 million and were stable excluding portfolio
streamlining.
Core assets
Net sales (€ million) |
Q1 2022 |
Change at CER |
Lovenox® |
377 |
-8.2% |
Toujeo® |
274 |
+6.3% |
Plavix® |
261 |
0.0% |
Multaq® |
87 |
+13.9% |
Thymoglobulin® |
97 |
+13.8% |
Mozobil® |
58 |
+5.8% |
Praluent® |
69 |
+21.4% |
Soliqua® |
53 |
+15.9% |
Rezurock® |
41 |
na |
Others |
277 |
+1.9% |
Total core assets |
1,594 |
+4.7% |
In the first quarter, core
assets sales increased 4.7% to €1,594 million, driven by
Toujeo®, Praluent®, Multaq®, Thymoglobulin® and Rezurock®
(consolidated from November 9, 2021), partially offset by lower
sales of Lovenox®. Core assets sales grew across
all geographies in the first quarter.
First-quarter Lovenox® sales
decreased 8.2% to €377 million, mainly reflecting lower sales in
the Rest of the World region (down 11.9%) due to high base of
comparison in the first quarter of 2021 which benefitted from
strong Covid-related demand (WHO guidelines recommending the use of
low molecular weight heparins in hospitalized COVID-19 patients).
In addition, biosimilar competition and supply limitations affected
the performance.
First-quarter Toujeo® sales
increased 6.3% to €274 million due to growth in Europe and the Rest
of the World region, partially offset by lower sales in the
U.S.
In China, the Volume Based Procurement (VBP) for
insulins is expected to be implemented in May 2022. In November
2021, Sanofi participated in the VBP tender for basal insulin
analogues and was among the bidding winners in the group A with
Lantus®/Toujeo®. Sanofi expects that its glargine (Toujeo®/Lantus®)
sales to decrease by around 30% in China in 2022, benefitting from
high volumes at significantly lower prices. In China,
Toujeo®/Lantus® sales were €459 million in 2021.
Plavix® sales were stable in
the first quarter to €261 million, higher sales in the Rest of the
World region (up 1.4%) offsetting lower sales in Europe. Plavix®
sales in China were down 3.4% to €123 million due to a high base of
comparison in the first quarter of 2021.
Multaq® first quarter sales
grew 13.9% to €87 million, reflecting strong U.S. sales growth.
Sales of Rezurock®, a 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, were consolidated as of November 9, 2021 (through
the Kadmon acquisition) and generated €41 million in the first
quarter. Rezurock® performance reflects the rapidly expanding pool
of prescribing institutions as well as pent-up demand from cGVHD
patients who have already failed multiple systemic therapies.
Praluent® first-quarter sales
were €69 million, up 21.4% driven by Europe performance. In Rest of
the World region, sales were up 6.7%. In China, Praluent® was
included in the NDRL list at the beginning of 2022.
First-quarter Soliqua® sales
increased 15.9% to €53 million driven by the Rest of World region
(up 54.5%) supported by new launches and Solimix results.
Non-core assets
Net sales (€ million) |
Q1 2022 |
Change at CER |
Lantus®* |
671 |
-1.5% |
Aprovel®/Avapro® |
125 |
+17.8% |
Other
non-core assets |
1,187 |
-7.4% |
Total non-core assets |
1,983 |
-4.2% |
In the first quarter, non-core assets
sales decreased 4.2% to €1,983 million reflecting
portfolio streamlining (-1.4ppt), lower Lantus® sales as well as
the impact of VBP wave 5 in China on Eloxatin® and Taxotere®
sales.
Lantus® sales were €671
million, down 1.5% in the first quarter, due to lower sales in
Europe, reflecting biosimilar competition and continuous Toujeo®
switches.
First-quarter
Aprovel®/Avapro®
sales were up 17.8% to €125 million, due to some supply improvement
and compared with a low base in the first quarter of
2021.
Pharmaceuticals
business operating income
In the first quarter, business operating
income (BOI) of Pharmaceuticals increased 12.6% to €2,831
million (up 8.8% at CER). The ratio of BOI to net sales increased
by 0.3 percentage point to 38.6% (38.8% at CER), reflecting an
improvement of the gross margin ratio.
Vaccines
Net sales (€ million) |
Q1 2022 |
Change at CER |
Polio/Pertussis/Hib
vaccines(incl. Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and
Imovax®) |
613 |
+10.3% |
Meningitis vaccines (incl.
Menactra®, MenQuadfi®) |
112 |
-16.4% |
Booster vaccines (incl. Adacel
®) |
109 |
+4.0% |
Travel and endemic
vaccines |
98 |
+61.0% |
Influenza vaccines(incl.
Fluzone® HD/ Efluelda®, Fluzone®, Flublok®, Vaxigrip®) |
66 |
-18.2% |
Other
vaccines |
22 |
+11.1% |
Total Vaccines |
1,020 |
+6.8% |
First-quarter Vaccines sales
increased 6.8% to €1,020 million driven by double-digit growth of
Polio/Pertussis/Hib vaccines sales and partial recovery of Travel
vaccines.
In the first quarter,
Polio/Pertussis/Hib (PPH) vaccines sales increased
10.3% to €613 million. In the Rest of the World region, PPH sales
grew 23.1% driven by a strong performance of
Pentaxim® in China compared to a low base last
year and favorable timing of polio tender delivery. In the U.S.,
PPH sales were impacted by inventory fluctuation and progressive
ramp up of Vaxelis® sales. As a reminder,
Vaxelis® in-market sales are not consolidated and
the profits are shared equally between Sanofi and Merck.
First-quarter Meningitis sales
decreased 16.4% to €112 million, due to lower sales in Latin
America reflecting price competition in public tenders.
Booster vaccines sales
increased 4.0% in the first quarter to €109 million, driven by the
Rest of the World region.
First-quarter Travel and endemic
vaccines sales increased 61.0% to €98 million, reflecting
a partial recovery of Travel vaccines in Europe and the U.S. as
well as higher endemic vaccines sales in the Rest of the World
region.
Influenza vaccines sales
decreased 18.2% in the first quarter, reaching €66 million due to
an exceptional high demand in the first quarter of 2021.
Vaccines business operating income
In the first quarter, business operating
income (BOI) decreased 20.2% (down 24.8% at CER) to €296
million compared to the same period of last year. This reflects
higher R&D expenses related to Translate Bio and the mRNA
center of excellence and the payment from Daiichi Sankyo recorded
in the first quarter of 2021. BOI to net sales ratio was 29.0%
(versus 40.5% in the first quarter of 2021, 27.5% excluding the
payment from Daiichi Sankyo).
Consumer Healthcare
Net sales (€ million) |
Q1 2022 |
Change at CER |
Allergy |
226 |
+11.3% |
Cough & Cold |
121 |
+118.2% |
Pain Care |
314 |
+22.5% |
Digestive Wellness |
325 |
+13.8% |
Physical and Mental
Wellness |
154 |
+14.9% |
Personal Care |
130 |
-2.4% |
Non-Core / Others |
58 |
-16.2% |
Total Consumer Healthcare |
1,328 |
+17.0% |
In the first quarter, Consumer
Healthcare (CHC) sales increased 17.0% to €1,328 million
sustained by growth in Europe and the Rest of the World region.
This performance was mainly driven by the strong demand for Cough
& Cold products, as well as the performance of Pain Care and
Digestive Wellness categories. This global performance includes a
positive price effect of 3%. The divestments of non-core products
had an impact of -0.6 ppt of growth in the first quarter.
In the U.S., first-quarter CHC
sales increased 2.1% to €310 million driven by double-digit growth
of Allergy category partially offset by lower sales of Personal
care and non-core assets mainly due to supply constraints.
In Europe, first-quarter CHC
sales increased 21.0% to €406 million mainly reflecting strong
growth of the Cough & Cold and Pain Care categories.
In Rest of World, first-quarter
CHC sales increased 22.8% to €612 million, supported by growth in
all categories.
CHC business operating
income
In the first quarter, business operating
income (BOI) of CHC increased 51.3% (up 48.0% at CER) to
€596 million. The ratio of BOI to net sales increased 9.5
percentage point to 44.9% versus the prior year, reflecting strong
top line growth as well as a capital gain related to divestments of
non-strategic assets.
Company sales by geographic region
Sanofi sales (€ million) |
Q1 2022 |
Change at CER |
United
States |
3,484 |
+12.1% |
Europe |
2,392 |
+6.7% |
Rest of the
World |
3,798 |
+7.0% |
of which China |
901 |
+13.4 % |
of which Japan |
433 |
+1.6 % |
of which Brazil |
260 |
-9.3% |
of
which Russia |
185 |
+34.4% |
Total Sanofi sales |
9,674 |
+8.6% |
First-quarter sales in the U.S.
increased +12.1% to €3,484 million supported by the strong
performance of Dupixent®.
In Europe sales increased +6.7%
in the first quarter to €2,392 million mainly driven by Dupixent®
performance as well as strong CHC growth.
In Rest of World sales
increased +7.0% to €3,798 million in the first quarter, reflecting
the performance of Dupixent®, CHC and Vaccines which largely offset
lower sales of General Medicines. Sales in China
increased 13.4% to €901 million mainly as a result of the growth of
Dupixent®, Vaccines and CHC. In Japan,
first-quarter sales increased 1.6% to €433 million driven by
Dupixent® and Sarclisa® which more than offset lower sales of
General Medicines. In Russia, due to strong cough,
cold and flu related sales, higher vaccines sales and unprecedented
stockpiling at pharmacy and patient level sales increased 34.4% in
the first quarter. In March, Sanofi has decided to stop any new
spending not related to the supply of its essential and
life-changing medicines and vaccines in Russia. This includes all
advertising and promotional spending.
R&D update at the end of the first quarter 2022
Regulatory update
-
The European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) has adopted a positive
opinion recommending to extend the approval of Dupixent®
(dupilumab) in the European Union to include add-on maintenance
treatment for children aged 6 to 11 years with severe
asthma with type 2 inflammation characterized by raised
blood eosinophils and/or raised fractional exhaled nitric oxide
(FeNO) who are inadequately controlled on two maintenance
therapies.
-
The U.S. Food and Drug Administration (FDA) has accepted
for Priority Review the supplemental Biologics License
Application (sBLA) for Dupixent® as an add-on maintenance treatment
for children aged 6 months to 5 years with
moderate-to-severe atopic dermatitis whose disease is not
adequately controlled with topical prescription therapies or when
those therapies are not advisable. The target action date for the
FDA decision on this investigational use is June 9, 2022. Dupixent®
remains the only biologic medicine approved for patients 6 years of
age and older in this indication.
-
The FDA has accepted for Priority Review the
supplemental Biologics License Application (sBLA) for Dupixent® 300
mg weekly to treat adults and adolescents aged 12 years and older
with eosinophilic esophagitis
(EoE), a chronic and
progressive type 2 inflammatory disease that damages the esophagus
and the ability to swallow.
- The FDA has approved Enjaymo™
(sutimlimab-jome), the first and only approved treatment to
decrease the need for red blood cell transfusion due to hemolysis
in adults with cold agglutinin disease (CAD). CAD
is a chronic and rare blood disorder that impacts the lives of an
estimated 5,000 people in the U.S. Sanofi estimates around 3,200
patients to be drug-treated per year and that Enjaymo could reach a
market share of around 25% in the years to come.
-
The Japanese Ministry of Health, Labor and Welfare (MHLW) has
granted marketing authorization
for Xenpozyme® (olipudase alfa) for the treatment of adult and
pediatric patients with non-central nervous system manifestations
of acid sphingomyelinase deficiency (ASMD).
Xenpozyme® is currently the only approved treatment for ASMD and
represents Sanofi’s first therapy to be approved under the SAKIGAKE
or pioneer designation, which is the Japanese government’s
regulatory fast-track pathway to promote research and development
of innovative new medical products addressing urgent unmet medical
needs.
-
The EMA has accepted the Marketing Authorization
Application (MAA) for nirsevimab under an accelerated
assessment procedure. Nirsevimab, the first investigational
long-acting antibody designed to protect all infants against
medically attended lower respiratory tract infections (LRTI) for
the respiratory syncytial virus (RSV) season, is
being developed by Sanofi and AstraZeneca. The New England Journal
of Medicine (NEJM) published detailed Phase 3 results of the MELODY
trial. In this study, with healthy infants born at term or late
preterm entering their first RSV season, the primary endpoint was
met, reducing the incidence of medically attended LRTI, such as
bronchiolitis or pneumonia, caused by RSV by 74.5% compared to
placebo.
- The EMA has started to
evaluate the application for the conditional marketing
authorization of the Sanofi-GSK first-generation
recombinant COVID-19 vaccine as a primary vaccine and a booster
designed to boost all currently approved COVID-19 vaccine
platforms. Final analysis of the VAT02 COVID-19
booster trial confirms universal ability to boost
neutralizing antibodies 18- to 30-fold across
vaccine platforms. The VAT08 primary series trial, with two doses
of the Sanofi-GSK vaccine in seronegative populations demonstrated
100% efficacy against severe COVID-19 disease and hospitalizations,
75% efficacy against moderate or severe COVID-19 disease, and 57.9%
efficacy against any symptomatic COVID-19 disease, in line with
expected vaccine effectiveness in today’s environment dominated by
variants of concern. When the Sanofi-GSK vaccine was used as a
two-dose primary series followed by a booster dose, neutralizing
antibodies increased 84- to 153-fold compared to
pre-boost levels.
-
Sanofi and Regeneron announced the voluntary withdrawal of
the sBLA for Libtayo® (cemiplimab-rwlc)
as a second-line treatment for patients with advanced
cervical cancer. The decision was made after the companies
and the FDA were not able to align on certain post-marketing
studies. Discussions with regulatory authorities outside of the
U.S. are ongoing.
Portfolio update
Phase 3:
-
Sanofi and Sobi announced positive topline results
from the pivotal XTEND-1 study evaluating the safety, efficacy and
pharmacokinetics of efanesoctocog alfa (BIVV001), a once-weekly
recombinant factor VIII therapy, in previously treated patients ≥12
years of age with severe hemophilia A. The study
met both primary and secondary endpoints, showing a clinically
meaningful prevention of bleeds in people with severe hemophilia A
over a period of 52 weeks, with a median annualized bleeding rate
(ABR) of 0 and a mean ABR of 0.71, and a superiority to prior
prophylactic factor VIII replacement therapy based on intra-patient
comparison. Sanofi plans to submit the data in the U.S. mid-2022.
Submission in the EU will follow the availability of data from the
ongoing XTEND-Kids pediatric study, expected in 2023.
-
A second trial (PRIME) evaluating Dupixent® in adults with
uncontrolled prurigo nodularis
(PN), met its primary and key secondary
endpoints, showing it significantly reduced itch and skin
lesions compared to placebo at 24 weeks in this investigational
setting. The data confirm the positive results that were previously
reported from the Phase 3 PRIME2 trial.
-
The LIBERTY-CPUO-CHIC study evaluating the efficacy and safety of
subcutaneous Dupixent® for the treatment of adult participants with
chronic pruritus of unknown origin (CPUO) has
initiated, and enrolled its first
participant.
-
The CUPID Study B evaluating Dupixent® in patients with
chronic spontaneous urticaria (CSU), who were
refractory to omalizumab, stopped due to futility
based on a pre-specified interim analysis. Although positive
numerical trends in reducing itch and hives were observed, the
results from the interim analysis did not demonstrate statistical
significance for the primary endpoints. The LIBERTY-CUPID pivotal
program was initiated in 2020 with an accelerated direct-to-Phase 3
strategy. The previously reported Phase 3 trial (Study A), which
evaluated a different group of patients who were biologic-naïve,
met its primary and all key secondary endpoints at 24 weeks showing
that adding Dupixent to standard-of-care antihistamines
significantly reduced itch and hives compared to antihistamines
alone. Sanofi and Regeneron remain committed to advancing Dupixent
for patients with CSU uncontrolled on antihistamines, next steps
are being evaluated including discussions with regulatory
authorities.
-
The clinical trial evaluating the efficacy and
safety of amcenestrant compared with tamoxifen in patients with
HR+ early breast cancer who have discontinued
adjuvant aromatase inhibitor (AI) therapy due to treatment related
toxicity (AMEERA-6), enrolled its first
participant.
Phase 2:
-
Three studies assessing rilzabrutinib have
initiated, and enrolled their
first participants: a randomized, double-blind, placebo-controlled
study in adults with moderate-to-severe asthma, a
randomized, double-blind, placebo-controlled study in
CSU, and an open-label study in adults with
Warm Autoimmune Hemolytic Anemia
(wAIHA).
-
The non-randomized and open-label study assessing the clinical
benefit of SAR444245 combined with other anticancer therapies for
the treatment of adults with advanced or metastatic
gastrointestinal cancer was initiated,
and was administered to the first
participant.
-
The pivotal AMEERA-3 clinical trial evaluating amcenestrant, an
investigational optimized oral selective estrogen receptor degrader
(SERD), as monotherapy compared to endocrine treatment of
physician’s choice in patients with locally advanced or
metastatic ER+/HER2- breast cancer who progressed on or
after hormonal therapies, did not meet its primary
endpoint of improving progression-free survival as assessed by an
independent central review.
Phase 1:
-
The study assessing the safety and efficacy of 4 investigational
HSV 2 vaccines in adults with recurrent genital herpes
caused by HSV 2 (HSV15) has been
discontinued.
Given the war in Ukraine and
the suffering of the Ukrainian people, Sanofi has adapted its
clinical trial implementation in the region. The company decided to
halt any new recruitment of patients for ongoing clinical trials in
Russia and Belarus, though it will continue to
treat patients already enrolled. In Ukraine, Sanofi is doing
everything it can to support and supply patients currently enrolled
in Sanofi-sponsored clinical trials, including transferring them
within Ukraine or into neighboring countries. In anticipation of
potential loss of data, the company is currently activating new
clinical sites and expanding patient enrollment in geographies not
impacted by the war. This may lead to the planned primary
completion dates of its pivotal trials in MS and COPD to shift,
previously communicated submission timelines remain unchanged.
Acquisitions and major collaborations
-
Sanofi and Blackstone announced a strategic, risk-sharing
collaboration under which funds managed by Blackstone Life
Sciences will contribute up to €300 million to accelerate the
global pivotal studies and the clinical development program for the
subcutaneous formulation and delivery of the anti-CD38 antibody
Sarclisa®, to treat patients with multiple myeloma
(MM), expecting to begin in the second half of 2022.
-
Sanofi announced the research collaboration and license
agreement to develop up to 15 novel small molecule
candidates across oncology and immunology with Exscientia,
leveraging their end-to-end AI-driven platform utilizing actual
patient samples. The companies have been working together since
2016 and in 2019, Sanofi in-licensed Exscientia’s novel bispecific
small molecule candidate capable of targeting two distinct targets
in inflammation and immunology.
-
Sanofi announced the completion of the acquisition
of Amunix Pharmaceuticals, Inc, adding a promising pipeline of
T-cell engagers and cytokine therapies. The acquisition also
provides access to their Pro-XTEN, XPAT, and XPAC technology to
deliver next generation conditionally activated biologics. The
technology platform is highly complementary to Sanofi’s existing
R&D platforms and supports Sanofi’s efforts to accelerate and
expand its contributions to innovative medicines for oncology
patients, with approximately 20 molecules currently in
development.
-
Sanofi and Seagen announced an exclusive collaboration
agreement to design, develop, and commercialize
antibody-drug conjugates (ADCs) for up to three cancer targets. The
collaboration will utilize both Sanofi’s proprietary monoclonal
antibody technology and Seagen’s proprietary ADC technology.
-
Sanofi and IGM Biosciences announced the signing of an
exclusive worldwide collaboration agreement to
create, develop, manufacture, and commercialize IgM antibody
agonists against three oncology targets and three
immunology/inflammation targets.
An update of the R&D pipeline at as of March
31, 2022, is available on Sanofi’s website:
https://www.sanofi.com/en/science-and-innovation/research-and-development
Progress on implementation of the Corporate Social
Responsibility strategy
Sanofi continues its progress to improve
access to medicines
Sustainability-linked bond tied to Sanofi’s Access
commitments
Sanofi is committed to integrate sustainability
within its Play to Win business strategy, as well as within its
investment and financing strategy. More than a year after issuing
its first sustainability-linked credit revolving facilities, Sanofi
successfully priced an inaugural sustainability-linked bond indexed
on access to medicines. A nominal amount of EUR 650 million of
notes, tied to Sanofi’s commitment to improve access to essential
medicines in low- and lower-middle-income countries via its global
health non-profit unit. This transaction demonstrates Sanofi’s
commitment to society, to ensure access to healthcare for the
world’s vulnerable people.
Access and Pricing Principles at
Sanofi
Sanofi has a long history of working with
healthcare systems to make its treatments accessible and affordable
to patients in need. Sanofi understands and shares concerns about
the affordability of medicines for patients and Sanofi encourages
countries to improve value in healthcare spending. However, the
Company firmly believes that the pharmaceutical industry is only
one of the many stakeholders in the healthcare system that can and
should contribute to this goal. Given the growing concerns over
rising healthcare costs, Sanofi has developed an approach to
pricing that reflects its commitment to broadly expanding patient
access to medicines and vaccines while maintaining sustainable
investment in Research & Development. The Access & Pricing
Principles it puts forth are founded on 2 pillars:
-
Clear rationale for pricing and access at the time of launch of a
new medicine or vaccine
-
Inclusion of affordability criteria into pricing considerations for
new launches
When the Company sets the price of a new
medicine, it holds itself to a rigorous and structured process that
includes consultation with external stakeholders and considers the
following factors:
-
Holistic assessment of value (clinical, social and wellbeing and
economic value)
-
Availability or anticipation of similar treatments at the time of
launch
-
Ability of market to afford new medicines
-
Unique factors specific to the medicine or vaccine at the time of
launch
Sanofi discloses more information on its global
access and pricing principles on its global website and
specifically on its U.S. pricing policy on the Sanofi U.S.
website.
Building partnerships to support
Sanofi’s pediatric cancer commitment
For the childhood cancer flagship program,
Sanofi aims to work together with partners, across sectors, to
advance knowledge in pediatric studies.
In the research field, Sanofi is now one of the
partners of the Pediatric Pre-clinical Proof of Concept Platform
(ITCC-P4) that aims to enable state of the art upfront preclinical
testing of novel molecularly targeted compounds. Sanofi has
recently engaged in a Pediatric Oncology Relevant Target
collaboration led by the Foundation for the National Institutes of
Health (FNIH) to review and prioritize targets.
For the development of innovative clinical
trials, Sanofi is proud to be working closely with experts at MD
Anderson Cancer Center, Institut Gustave Roussy, Children's
Hospital of Philadelphia, Dana-Farber Cancer Institute, Memorial
Sloan Kettering Cancer Center. All of these efforts are centered on
patient needs as highlighted by Sanofi’s support to childhood
cancer advocacy groups including Coalition Against Childhood Cancer
(CAC2) and Imagine for Margo.
ESG dashboard
In 2020, as Sanofi renewed its CSR ambitions,
the Company reviewed and updated its portfolio of initiatives.
Numbers shown below highlight the ongoing progress in the
implementation of Sanofi’s CSR strategy.
Affordable access
Sanofi Global Health, a non-profit unit formed
within the company in April 2021, aims to provide 30 of Sanofi's
medicines across a wide range of therapeutic areas to patients in
40 of the lowest income countries. Beyond the products provided,
Sanofi Global Health will also focus on integrated programs that
ensure optimal care management over time for patients.
Sanofi is also committed to helping 1,000
patients living with rare diseases who have no access to treatments
and will donate 100,000 vials of medicine for their treatments each
year. This continues Sanofi’s 30-year commitment to patients
suffering from rare diseases, such as Fabry, Gaucher or Pompe
diseases, for which access to treatment is often limited.
The third initiative on access is to develop a
global access plan for all new products, making them available in
selected relevant markets within two years of launch.
Dashboard for affordable access |
|
|
Sanofi Global Health |
|
FY 2021 |
Q1 2022 |
Malaria |
- 9,276,504 patients
treated
- 23 countries
|
- 1,024,170 patients
treated
- 8 countries
|
Tuberculosis |
- 146,356 patients
treated
- 28 countries
|
- 35,094 patients
treated
- 11 countries
|
NCD |
- 40,439 patients
treated
- 16 countries
|
- 46,300 patients
treated
- 12 countries
|
Vials donation |
|
FY 2021 |
Q1 2022 |
# Patients treated |
1,083 |
998 |
#Vials donated |
109,677 |
22,682 |
Global access Plan |
|
FY 2021 |
Q1 2022 |
# of access plan |
Pilot phase in progress |
Innovating for vulnerable communities
Sanofi continues its efforts to fight polio and
sleeping sickness, two of its legacy programs that address global
health issues.
Sanofi has been involved in the fight against
polio from the beginning and continues to play a critical role in
the delivery of polio vaccines. The Company has also committed to
collaborate with the WHO to eliminate sleeping sickness by
2030.
Part of Sanofi’s R&D ambition is to develop
innovative medicines to eliminate cancer deaths in children.
Dashboard for vulnerable communities |
Eradicate Polio |
|
FY 2021 |
Q1 2022 |
# IPV doses supplied |
50.5 million IPV doses supplied to UNICEF for GAVI
countries |
16 million IPV doses supplied to UNICEF for GAVI
countries |
Eliminate sleeping sickness |
|
FY 2020 |
FY 2021 |
# Patients tested |
1.6 million |
Data available at Q2 2022 |
# Patients treated |
663 |
Develop innovative medicines against childhood
cancer |
|
FY 2021 |
Q1 2022 |
# of assets identified |
2 assets identified; preclinical studies
started |
1 of the 2 assets in protocol preparation
for clinical study |
Protecting the planet
To contribute to better resource conservation,
Sanofi plans to remove all plastic blister packs for its vaccines
by 2027. In addition, the company is committed to eco-designing all
its new products by 2025. To reduce its greenhouse gas emissions by
55% by 2030, all Sanofi sites will use 100% electricity from
renewable sources and the Company has set a target of a
carbon-neutral for its car fleet, both by 2030.
Dashboard for planet |
Blister free vaccines |
|
FY 2021 |
Q1 2022 |
% blister free vaccines |
29% of blister free vaccines produced |
Data updated annually |
Eco design |
|
FY 2021 |
Q1 2022 |
# of Life Cycle Analysis (LCA) |
4 LCAs conducted |
4 LCAs completed & 1 in progressEco-design
digital solutions project launched |
Scope 1 & 2 emissions |
|
Q4 2021 |
Q1 2022 |
GHG reduction vs 2019 % |
-25% |
-26% |
Renewable electricity |
|
Q4 2021 |
Q1 2022 |
% electricity consumption from renewable sources |
50% |
61% |
Eco car fleet |
|
Q4 2021 |
Q1 2022 |
% eco car fleet on total car fleet |
26.2% eco-fleet |
28.7% eco-fleet |
Building an inclusive workplace
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’s ambition
is to have 40% of women in top executive roles and 50% of women in
senior leadership roles by 2025. Sanofi is continuing its social
and economic engagement in the communities it operates in. Finally,
Sanofi is embedding its commitment to society in its leaders’
career development paths to strengthen the social impact of their
decisions.
Dashboard for inclusive workplace |
|
Q4 2021 |
Q1 2022 |
Diverse Senior Leadership |
% of women |
34.2% of our top executives40.1%
of our senior leaders |
35.1% of our top executives40.4%
of our senior leaders |
Strengthen social & economic engagement in all
communities where we operate |
|
FY 2021 |
Q1 2022 |
# volunteers |
4,975 volunteers |
Next update in Q2 2022 |
# hours |
26,906 hours |
From Leaders to Citizens |
|
Q4 2021 |
Q1 2022 |
KPI |
Roll out planned in 2022 |
ESG ratings
Sanofi was recognized as one of the most
sustainability-committed companies in an ESG Evaluation
(Environment, Social, Governance) performed by Standard &
Poor’s Global Ratings (S&P).
The ESG Evaluation awarded Sanofi a score of 86
out of 100 points, one of the highest scores across all sectors
globally. Sanofi’s ESG profile was awarded 80 points for its solid
fundamentals, completed with an additional strong preparedness
opinion of 6 points awarded for its excellent awareness of risks
and opportunities and its capacity to anticipate and adapt to a
variety of long-term plausible disruptions.
Sanofi's Social Profile was ranked as ‘leading’
in the category of communities highlighting the recent 2021
creation of its global health unit which aims to provide 30 of
Sanofi's medicines across a wide range of therapeutic areas to
patients in 40 of the lowest income countries. The report also
noted Sanofi’s commitment to eliminating infectious disease such as
polio, sleeping sickness and malaria.
Sanofi was notably distinguished for its
commitment to access to medicines, particularly in vulnerable
communities. The study, which recognized ‘the increasing challenges
and inequalities in healthcare across all geographies’, identified
the creation of a non-profit unit dedicated to providing poorest
countries with access to essential medicines as one of Sanofi's
leading differentiators.
The continuous implementation of Sanofi’s social
impact strategy has led in recent months to a range of positive
updates of the company’s rank or grade in most of the ESG
rankings.
Covid Update
Sanofi and GSK applied for regulatory
authorization of their first-generation COVID-19 vaccine in Europe
with data supporting its use as a universal booster, designed to
boost all currently approved COVID-19 vaccine platforms. In
addition, the companies are developing a
next-generation booster vaccine designed to
provide broad protection against all variants of concern, from the
original strain to Omicron BA.2. The data (VAT02 Cohort 2) is
expected to be communicated in Q2 2022. First-quarter
2022 financial results
Business Net Income2
In the first quarter of 2022, Sanofi generated
net sales of €9,674 million, an increase of 12.6%
(up 8.6% at CER).
First-quarter other revenues increased 28.5%
(up 23.7% at CER) to €379 million, including VaxServe sales
contribution of non-Sanofi products of €286 million (up 16.7 % at
CER).
First-quarter Gross Profit
increased 15.7% (up 11.1% at CER) to €7,175 million. The gross
margin ratio increased 2.0 percentage points to 74.2% versus the
first quarter of 2021, reflecting strong improvement of the
Pharmaceuticals gross margin ratio (which increased from 75.2% to
77.9%) driven by favorable impact of growing weight of Specialty
Care, efficiency gains in Industrial Affairs and lower royalty
expenses. The Vaccines gross margin ratio slightly decreased to
61.6% from 62.0%. CHC gross margin ratio was 67.3%, down 0.7
percentage point.
Research and Development
(R&D) expenses increased 17.5% (up 14.0% at CER) to €1,489
million in the first quarter, reflecting increase in priority
assets development as well as recent acquisitions.
First-quarter selling general and
administrative expenses (SG&A) increased 8.4% to
€2,379 million. At CER, SG&A expenses were up 4.3%, reflecting
increased commercial investments in Specialty Care growth drivers
which were partially offset by continued streamlining initiatives.
In the first quarter, the ratio of SG&A to sales decreased 0.9
percentage point to 24.6% compared to the prior year.
First-quarter operating
expenses were €3,868 million, an increase of 11.8% and
7.8% at CER.
First-quarter other current operating
income net of expenses was -€265 million versus -€101
million in the first quarter of 2021. Other current operating
income net of expenses included an expense of €477 million (versus
an expense of €279 million in the first quarter of 2021)
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 quarter, this line
also included €232 million of net capital gains related to General
Medicines and CHC portfolio streamlining compared to €56million in
the same period of 2021.
The share of profit from
associates was €30 million versus €9 million in the first
quarter of 2021 and included the share of U.S profit related to
Vaxelis®.
First-quarter business operating
income2 (BOI) increased 16.2% to €3,065
million. At CER, BOI increased 12.2%. The ratio of BOI to net sales
increased 1.0 percentage point to 31.7% mainly reflecting gross
margin ratio improvement.
Net financial expenses were €78
million versus €84 million in the same period of 2021.
First-quarter effective tax
rate was 19.0% versus 21.0% in the prior year. Sanofi
expects its effective tax rate to be around 19% in 2022.
First-quarter business net
income2 increased 20.2% to €2,424 million
and increased 16.0% at CER. The ratio of business net income to net
sales increased 1.6 percentage point to 25.1% versus the first
quarter of 2021.
In the first quarter of 2022, business
earnings per share2 (EPS) was €1.94, up
20.5% on a reported basis (up 16.1% at CER). The average number of
shares outstanding was 1,249.2 million versus 1,249.3 million in
first quarter 2021.
Reconciliation of IFRS net income reported
to business net income (see Appendix 4)
In the first quarter of 2022, the IFRS net
income was €2,009 million. The main items excluded from the
business net income were:
- An amortization
charge of €449 million related to fair value remeasurement on
intangible assets of acquired companies (primarily Genzyme: €145
million, Bioverativ: €88 million, Boehringer Ingelheim CHC
business: €48 million, Ablynx: €42 million and Kadmon: €37 million)
and to acquired intangible assets (licenses/products: €24 million).
These items have no cash impact on the Company.
- An impairment of
intangible assets of €5 million.
- Restructuring costs
and similar items of €175 million related to streamlining
initiatives.
- A €232 million tax
effect arising from the items listed above, mainly comprising €96
million of deferred taxes generated by amortization and impairments
of intangible assets and €46 million associated with restructuring
costs and similar items (see Appendix 4).
Capital Allocation
In the first quarter of 2022, free cash flow
before restructuring, acquisitions and disposals decreased by 15.5%
to €1,998 million, after net changes in working capital (-€468
million) and capital expenditures (-€356 million). After
acquisitions (-€277 million), proceeds from disposals3 (+€347
million) and payments related to restructuring and similar items
(-€361 million), free cash flow4 decreased by
11.3% to €1,707 million. After the acquisition of Amunix (-€803
million), net debt decreased from €9,983 million at December 31,
2021 to €9,432 million at March 31, 2022 (amount net of €8,728
million cash and cash equivalents).
Forward-Looking StatementsThis 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, 2021. Other
than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
Appendices
Appendix 1: |
First-quarter 2022
sales by GBU, franchise, geographic region and product |
Appendix 2: |
First-quarter 2022
business net income statement |
Appendix 3: |
First-quarter 2022
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 |
Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.comNicolas Obrist
| + 33 6 77 21 27 55 | nicolas.obrist@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.comSally Bain | + 1
617 834 6026 | sally.bain@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69 36 93
| arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40 56 92
| corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239
| felix.lauscher@sanofi.comPriya Nanduri | +1
617 764 6418 | priya.nanduri@sanofi.com
Nathalie Pham | + 33 7 85 93 30
17 | nathalie.pham@sanofi.com
Appendix 1: 2022 first-quarter net sales by GBU, franchise,
geographic region and product
Q1 2022 (€ million) |
Total Sales |
% CER |
% reported |
|
United States |
% CER |
|
Europe |
% CER |
|
Rest of the world |
% CER |
Dupixent |
1,614 |
+45.7 % |
+54.2 % |
|
1,176 |
+38.1 % |
|
211 |
+53.3 % |
|
227 |
+88.0 % |
Aubagio |
491 |
-6.6 % |
-1.8 % |
|
329 |
-9.7 % |
|
132 |
0.0 % |
|
30 |
0.0 % |
Lemtrada |
25 |
0.0 % |
+4.2 % |
|
11 |
0.0 % |
|
6 |
+20.0 % |
|
8 |
-11.1 % |
Kevzara |
95 |
+61.4 % |
+66.7 % |
|
50 |
+88.0 % |
|
28 |
+33.3 % |
|
17 |
+54.5 % |
Neurology & Immunology |
611 |
+0.3 % |
+5.2 % |
|
390 |
-2.9 % |
|
166 |
+5.1 % |
|
55 |
+10.2 % |
Cerezyme |
165 |
-6.7 % |
-7.3 % |
|
45 |
+5.0 % |
|
60 |
-4.8 % |
|
60 |
-14.7 % |
Cerdelga |
67 |
+3.2 % |
+8.1 % |
|
36 |
+3.1 % |
|
27 |
+3.8 % |
|
4 |
0.0 % |
Myozyme |
235 |
-3.0 % |
0.0 % |
|
82 |
-13.6 % |
|
103 |
+4.1 % |
|
50 |
+2.0 % |
Nexviazyme |
30 |
0.0 % |
0.0 % |
|
26 |
0.0 % |
|
1 |
0.0 % |
|
3 |
0.0 % |
Fabrazyme |
220 |
+2.4 % |
+5.8 % |
|
105 |
+4.3 % |
|
58 |
+1.8 % |
|
57 |
0.0 % |
Aldurazyme |
69 |
+3.0 % |
+4.5 % |
|
13 |
0.0 % |
|
24 |
0.0 % |
|
32 |
+6.5 % |
Rare Disease |
804 |
+1.9 % |
+4.4 % |
|
307 |
+7.2 % |
|
274 |
+1.9 % |
|
223 |
-3.8 % |
Jevtana |
98 |
-25.4 % |
-22.2 % |
|
68 |
+8.6 % |
|
11 |
-75.6 % |
|
19 |
-13.0 % |
Fasturtec |
40 |
+8.6 % |
+14.3 % |
|
24 |
+9.5 % |
|
12 |
+9.1 % |
|
4 |
0.0 % |
Libtayo |
41 |
+53.8 % |
+57.7 % |
|
— |
0.0 % |
|
34 |
+50.0 % |
|
7 |
+75.0 % |
Sarclisa |
65 |
+85.3 % |
+91.2 % |
|
25 |
+100.0 % |
|
22 |
+69.2 % |
|
18 |
+88.9 % |
Oncology |
244 |
+6.8 % |
+10.4 % |
|
117 |
+20.9 % |
|
79 |
-14.3 % |
|
48 |
+23.1 % |
Alprolix |
108 |
+2.0 % |
+8.0 % |
|
92 |
+8.9 % |
|
— |
0.0 % |
|
16 |
-23.8 % |
Eloctate |
138 |
-3.0 % |
+3.0 % |
|
108 |
-1.9 % |
|
— |
0.0 % |
|
30 |
-6.5 % |
Cablivi |
46 |
+15.8 % |
+21.1 % |
|
22 |
-4.5 % |
|
23 |
+46.7 % |
|
1 |
0.0 % |
Rare Blood Disorder |
293 |
+1.8 % |
+7.7 % |
|
223 |
+2.5 % |
|
23 |
+46.7 % |
|
47 |
-13.2 % |
Specialty Care |
3,566 |
+17.8 % |
+23.3 % |
|
2,213 |
+19.3 % |
|
753 |
+12.0 % |
|
600 |
+20.4 % |
|
|
|
|
|
|
|
|
|
|
|
|
|
Lovenox |
377 |
-8.2 % |
-6.0 % |
|
5 |
-61.5 % |
|
185 |
-0.5 % |
|
187 |
-11.9 % |
Toujeo |
274 |
+6.3 % |
+8.3 % |
|
58 |
-12.9 % |
|
104 |
+9.6 % |
|
112 |
+15.5 % |
Plavix |
261 |
0.0 % |
+4.0 % |
|
3 |
0.0 % |
|
26 |
-10.3 % |
|
232 |
+1.4 % |
Multaq |
87 |
+13.9 % |
+20.8 % |
|
78 |
+17.7 % |
|
5 |
-16.7 % |
|
4 |
0.0 % |
Thymoglobulin |
97 |
+13.8 % |
+21.3 % |
|
56 |
+13.0 % |
|
8 |
0.0 % |
|
33 |
+19.2 % |
Mozobil |
58 |
+5.8 % |
+11.5 % |
|
31 |
+3.6 % |
|
15 |
+7.1 % |
|
12 |
+10.0 % |
Praluent |
69 |
+21.4 % |
+23.2 % |
|
— |
-100.0 % |
|
53 |
+44.4 % |
|
16 |
+6.7 % |
Soliqua/iGlarLixi |
53 |
+15.9 % |
+20.5 % |
|
30 |
+3.8 % |
|
8 |
0.0 % |
|
15 |
+54.5 % |
Rezurock |
41 |
0.0 % |
0.0 % |
|
41 |
0.0 % |
|
— |
0.0 % |
|
— |
0.0 % |
Others core assets |
277 |
+1.9 % |
+4.5 % |
|
39 |
-37.5 % |
|
95 |
+10.6 % |
|
143 |
+13.7 % |
Core Assets |
1,594 |
+4.7 % |
+8.1 % |
|
341 |
+5.0 % |
|
499 |
+6.5 % |
|
754 |
+3.4 % |
Lantus |
671 |
-1.5 % |
+2.9 % |
|
208 |
+0.5 % |
|
112 |
-11.2 % |
|
351 |
+0.9 % |
Aprovel |
125 |
+17.8 % |
+23.8 % |
|
1 |
-50.0 % |
|
21 |
-8.7 % |
|
103 |
+27.6 % |
Others non-core assets |
1,187 |
-7.4 % |
-5.6 % |
|
95 |
-2.2 % |
|
300 |
-8.8 % |
|
792 |
-7.4 % |
Non-Core Assets |
1,983 |
-4.2 % |
-1.3 % |
|
304 |
-0.7 % |
|
433 |
-9.4 % |
|
1,246 |
-3.1 % |
Industrial Sales |
183 |
-4.3 % |
-2.7 % |
|
10 |
-18.2 % |
|
168 |
+5.8 % |
|
5 |
-71.4 % |
General Medicines |
3,760 |
-0.7 % |
+2.4 % |
|
655 |
+1.8 % |
|
1,100 |
-0.5 % |
|
2,005 |
-1.5 % |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals |
7,326 |
+7.5 % |
+11.6 % |
|
2,868 |
+14.8 % |
|
1,853 |
+4.2 % |
|
2,605 |
+2.9 % |
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
613 |
+10.3 % |
+15.0 % |
|
125 |
-14.1 % |
|
78 |
0.0 % |
|
410 |
+23.1 % |
Booster Vaccines |
109 |
+4.0 % |
+9.0 % |
|
53 |
+2.1 % |
|
31 |
-8.8 % |
|
25 |
+33.3 % |
Meningitis |
112 |
-16.4 % |
-12.5 % |
|
76 |
-6.6 % |
|
2 |
0.0 % |
|
34 |
-34.6 % |
Influenza Vaccines |
66 |
-18.2 % |
-14.3 % |
|
12 |
0.0 % |
|
4 |
-55.6 % |
|
50 |
-29.4 % |
Travel and Endemic Vaccines |
98 |
+61.0 % |
+66.1 % |
|
23 |
+57.1 % |
|
17 |
+240.0 % |
|
58 |
+40.0 % |
Vaccines |
1,020 |
+6.8 % |
+11.5 % |
|
306 |
-0.4 % |
|
133 |
+4.7 % |
|
581 |
+11.3 % |
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy |
226 |
+11.3 % |
+15.9 % |
|
131 |
+15.1 % |
|
17 |
-5.6 % |
|
78 |
+9.9 % |
Cough and Cold |
121 |
+118.2 % |
+120.0 % |
|
— |
0.0 % |
|
66 |
+164.0 % |
|
55 |
+80.0 % |
Pain Care |
314 |
+22.5 % |
+24.1 % |
|
46 |
+7.5 % |
|
151 |
+23.8 % |
|
117 |
+27.5 % |
Digestive Wellness |
325 |
+13.8 % |
+14.8 % |
|
29 |
+8.0 % |
|
112 |
+5.7 % |
|
184 |
+20.3 % |
Physical Wellness |
88 |
+7.4 % |
+8.6 % |
|
— |
0.0 % |
|
6 |
-25.0 % |
|
82 |
+11.0 % |
Mental Wellness |
66 |
+26.4 % |
+24.5 % |
|
12 |
0.0 % |
|
34 |
+17.2 % |
|
20 |
+69.2 % |
Personal Care |
130 |
-2.4 % |
+4.0 % |
|
96 |
-7.3 % |
|
1 |
0.0 % |
|
33 |
+14.3 % |
Non-Core / Others |
58 |
-16.2 % |
-14.7 % |
|
(4) |
-160.0 % |
|
19 |
-30.8 % |
|
43 |
+13.5 % |
Consumer Healthcare |
1,328 |
+17.0 % |
+19.3 % |
|
310 |
+2.1 % |
|
406 |
+21.0 % |
|
612 |
+22.8 % |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
9,674 |
+8.6 % |
+12.6 % |
|
3,484 |
+12.1 % |
|
2,392 |
+6.7 % |
|
3,798 |
+7.0 % |
Appendix 2: Business net income statement
First Quarter 2022 |
Pharmaceuticals |
Vaccines |
Consumer Healthcare |
Other(1) |
Total Group |
€ million |
Q1 2022 |
Q1 2021(2) |
Change |
Q1 2022 |
Q1 2021(2) |
Change |
Q1 2022 |
Q1 2021(2) |
Change |
Q1 2022 |
Q1 2021(2) |
Change |
Q1 2022 |
Q1 2021(2) |
Change |
Net
sales |
7,326 |
6,563 |
11.6% |
1,020 |
915 |
11.5% |
1,328 |
1,113 |
19.3% |
— |
— |
—% |
9,674 |
8,591 |
12.6% |
Other revenues |
75 |
50 |
50.0% |
289 |
231 |
25.1% |
14 |
14 |
—% |
1 |
— |
—% |
379 |
295 |
28.5% |
Cost of Sales |
(1,695) |
(1,679) |
1.0% |
(681) |
(579) |
17.6% |
(448) |
(370) |
21.1% |
(54) |
(56) |
-3.6% |
(2,878) |
(2,684) |
7.2% |
As % of net sales |
(23.1)% |
(25.6)% |
|
(66.8)% |
(63.3)% |
|
(33.7)% |
(33.2)% |
|
|
|
|
(29.7)% |
(31.2)% |
|
Gross
Profit |
5,706 |
4,934 |
15.6% |
628 |
567 |
10.8% |
894 |
757 |
18.1% |
(53) |
(56) |
-5.4% |
7,175 |
6,202 |
15.7% |
As % of net
sales |
77.9% |
75.2% |
|
61.6% |
62.0% |
|
67.3% |
68.0% |
|
|
|
|
74.2% |
72.2% |
|
Research and development
expenses |
(1,165) |
(979) |
19.0% |
(185) |
(145) |
27.6% |
(36) |
(28) |
28.6% |
(103) |
(115) |
-10.4% |
(1,489) |
(1,267) |
17.5% |
As % of net sales |
(15.9)% |
(14.9)% |
|
(18.1)% |
(15.8)% |
|
(2.7)% |
(2.5)% |
|
|
|
|
(15.4)% |
(14.7)% |
|
Selling and general
expenses |
(1,308) |
(1,188) |
10.1% |
(170) |
(170) |
—% |
(382) |
(344) |
11.0% |
(519) |
(492) |
5.5% |
(2,379) |
(2,194) |
8.4% |
As % of net sales |
(17.9)% |
(18.1)% |
|
(16.7)% |
(18.6)% |
|
(28.8)% |
(30.9)% |
|
|
|
|
(24.6)% |
(25.5)% |
|
Other current operating
income/expenses |
(411) |
(252) |
|
7 |
120 |
|
122 |
10 |
|
17 |
21 |
|
(265) |
(101) |
|
Share of profit/loss of
associates* and joint ventures |
14 |
7 |
|
16 |
(1) |
|
— |
3 |
|
— |
— |
|
30 |
9 |
|
Net income attributable to non
controlling interests |
(5) |
(8) |
|
— |
— |
|
(2) |
(4) |
|
— |
— |
|
(7) |
(12) |
|
Business operating
income |
2,831 |
2,514 |
12.6% |
296 |
371 |
-20.2% |
596 |
394 |
51.3% |
(658) |
(642) |
2.5% |
3,065 |
2,637 |
16.2% |
As % of net
sales |
38.6% |
38.3% |
|
29.0% |
40.5% |
|
44.9% |
35.4% |
|
|
|
|
31.7% |
30.7% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income
and expenses |
(78) |
(84) |
|
|
|
|
|
Income tax
expenses |
|
|
|
|
(563) |
(537) |
|
|
|
|
|
Tax rate** |
|
|
|
|
19.0% |
21.0% |
|
|
|
|
|
Business
net income |
|
|
|
|
2,424 |
2,016 |
20.2% |
|
|
|
|
As % of
net sales |
|
|
|
|
25.1% |
23.5% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business
earnings / share(in
euros)*** |
1.94 |
1.61 |
20.5% |
* 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 1,249.2 million in the first quarter of 2022 and
1,249.3 million in the first quarter of 2021.
(1) Other includes the cost of global support
functions (Finance, Human Resources, Information Solution &
Technologies, Sanofi Business Services,
etc…).(2) Includes the impacts of the IFRIC final agenda
decision of April 2021 on the attribution of benefits to periods of
service.
Appendix 3: Consolidated income statements
€ million |
Q1 2022 |
Q1 2021 (1) |
Net
sales |
9,674 |
8,591 |
Other revenues |
379 |
295 |
Cost of sales |
(2,880) |
(2,684) |
Gross
profit |
7,173 |
6,202 |
Research and development expenses |
(1,489) |
(1,267) |
Selling and general expenses |
(2,379) |
(2,194) |
Other operating income |
390 |
267 |
Other operating expenses |
(655) |
(368) |
Amortization of intangible assets |
(449) |
(389) |
Impairment of intangible assets |
(5) |
(2) |
Fair value remeasurement of contingent consideration |
4 |
(36) |
Restructuring costs and similar items |
(175) |
(156) |
Other gains and losses, and litigation |
(18) |
— |
Operating
income |
2,397 |
2,057 |
Financial expenses |
(88) |
(98) |
Financial income |
10 |
14 |
Income before tax and
associates and joint ventures |
2,319 |
1,973 |
Income tax expense |
(332) |
(404) |
Share of profit/(loss) of associates and joint ventures |
30 |
9 |
Net
income |
2,017 |
1,578 |
Net income attributable to non-controlling interests |
8 |
12 |
Net income
attributable to equity holders of Sanofi |
2,009 |
1,566 |
Average number of shares
outstanding (million) |
1,249.2 |
1,249.3 |
IFRS Earnings per share (in euros) |
1.61 |
1.25 |
(1) Includes the impacts of the IFRIC final
agenda decision of April 2021 on the attribution of benefits to
periods of serviceAppendix 4: Reconciliation of Net income
attributable to equity holders of Sanofi to Business net income
€ million |
Q1 2022 |
Q1 2021 (1) |
Net income
attributable to equity holders of Sanofi |
2,009 |
1,566 |
Amortization of intangible
assets (2) |
449 |
389 |
Impairment of intangible
assets |
5 |
2 |
Fair value remeasurement of
contingent consideration |
(4) |
36 |
Expenses arising from the
impact of acquisitions on inventories |
3 |
— |
Restructuring costs and
similar items |
175 |
156 |
Other gains and losses, and
litigation |
18 |
— |
Tax effect of the items listed
above: |
(232) |
(133) |
Amortization and impairment of intangible assets |
(96) |
(89) |
Fair value remeasurement of contingent consideration |
(7) |
(1) |
Restructuring costs and similar items |
(46) |
(42) |
Other tax effects |
(83) |
(1) |
Share of items listed above
attributable to non-controlling interests |
1 |
— |
Business net
income |
2,424 |
2,016 |
IFRS earnings per share (3)
(in euros) |
1.61 |
1.25 |
(1) Includes the impacts of the IFRIC final
agenda decision of April 2021 on the attribution of benefits to
periods of service.
(2) Of which related to amortization expense
generated by the remeasurement of intangible assets as part of
business combinations: €425 million in the first quarter of 2022
and €369 million in the first quarter of 2021.
(3) Based on an average number of shares
outstanding of 1,249.2 million in the first quarter of 2022 and
1,249.3 million in the first quarter of 2021.
Appendix 5: Change in net debt
€ million |
Q1 2022 |
Q1 2021 |
(1) |
Business net
income |
2,424 |
2,016 |
|
Depreciation &
amortization & impairment of property, plant and equipment and
software |
361 |
347 |
|
Other items |
37 |
(43) |
|
Operating cash
flow |
2,822 |
2,320 |
|
Changes in Working
Capital |
(468) |
422 |
|
Acquisitions of property,
plant and equipment and software |
(356) |
(378) |
|
Free cash flow before
restructuring, acquisitions and disposals |
1,998 |
2,364 |
|
Acquisitions of intangibles
assets, investments and other long-term financial assets (2) |
(277) |
(277) |
|
Restructuring costs and
similar items paid |
(361) |
(244) |
|
Proceeds from disposals of
property, plant and equipment, intangible assets and other
non-current assets net of taxes (2) |
347 |
82 |
|
Free cash
flow |
1,707 |
1,925 |
|
Acquisitions of investments in
consolidated undertakings includingassumed debt (3) |
(823) |
(21) |
|
Issuance of Sanofi shares |
13 |
11 |
|
Acquisition of treasury
shares |
(360) |
(140) |
|
Other items |
14 |
192 |
|
Change in net debt |
551 |
1,967 |
|
Beginning of period |
9,983 |
8,790 |
|
Closing of net debt |
9,432 |
6,823 |
|
(1) Includes the impacts of the IFRIC final
agenda decision of April 2021 on the attribution of benefits to
periods of service.
(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
2022 business EPS currency sensitivity
Currency |
Variation |
Business EPS Sensitivity |
U.S. Dollar |
+0.05 USD/EUR |
-EUR0.14 |
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 2022 sales
Currency |
Q1 2022 |
US $ |
37.0 % |
Euro € |
21.0 % |
Chinese Yuan |
8.8 % |
Japanese Yen |
4.4 % |
Brazilian Real |
2.5 % |
Russian ruble |
1.8 % |
Hungarian Forint |
1.7 % |
Canadian $ |
1.4 % |
Australian $ |
1.4 % |
British Pound |
1.4 % |
Others |
18.6 % |
Currency average rates
|
Q1 2021 |
Q1 2022 |
Change |
€/$ |
1.21 |
1.12 |
-6.9 % |
€/Yen |
127.69 |
130.47 |
+2.2 % |
€/Yuan |
7.81 |
7.14 |
-8.6 % |
€/Real |
6.59 |
5.88 |
-10.8 % |
€/Ruble |
89.72 |
97.95 |
+9.2 % |
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 2022
€ million |
Q1 2022 |
Net
sales |
9,674 |
Effect of exchange rates |
341 |
Company sales at constant exchange rates |
9,333 |
Business net income
Sanofi publishes a key non-GAAP indicator.
Business net income is defined as net income attributable to equity
holders of Sanofi excluding:
-
amortization of intangible assets,
-
impairment of intangible assets,
-
fair value remeasurement of contingent consideration related to
business combinations or to disposals,
-
other impacts associated with acquisitions (including impacts of
acquisitions on associates and joint ventures),
-
restructuring costs and similar items(1),
-
other gains and losses (including gains and losses on disposals of
non-current assets(1)),
-
costs or provisions associated with litigation(1),
-
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
definition in Appendix 73 Not exceeding €500 million per
transaction (inlusive of all payments related to the transaction).4
Non-GAAP financial measure (definition in Appendix 7).
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