Sanofi Q3 well on track
Paris, October 31, 2019
Sanofi Q3 well on track
|
Q3 2019 |
Change |
Change at CER |
9M 2019 |
Change |
Change at CER |
IFRS net sales reported |
€9,499m |
+1.1% |
-1.1% |
€26,518m |
+4.1% |
+2.2% |
IFRS net income reported |
€1,766m |
-22.3% |
- |
€2,816m |
-30.5%(2) |
- |
IFRS EPS reported |
€1.49 |
-18.6% |
- |
€2.33 |
-28.3%(2) |
- |
Business net income(1) |
€2,399m |
+4.3% |
+0.2% |
€5,805m |
+6.4% |
+4.1% |
Business EPS(1) |
€1.92 |
+4.3% |
0.0% |
€4.65 |
+6.4% |
+4.1% |
Third-quarter 2019 sales performance(3) led by Sanofi
Genzyme and Emerging Markets
- Net sales were €9,499 million, up 1.1% on a reported basis,
down 1.1%(3) at CER and up 0.5% at CER/CS(4).
- Sanofi Genzyme sales increased 19.5% driven by continued strong
uptake of Dupixent®.
- Vaccines sales decreased 9.8% reflecting anticipated weighting
of U.S. flu vaccines supply towards fourth quarter.
- CHC sales up 0.4%, impacted by Zantac® voluntary recall,
non-core divestments and increased regulatory requirements.
- Primary Care sales declined 12.7% at CER/CS due to lower sales
in Diabetes and Established Products.
- Emerging Markets(5) sales grew 9.7% due to strong performance
in most regions.
Full-year business EPS guidance confirmed
- Q3 2019 business net income increased 4.3% to €2,399 million
and 0.2% at CER.
- Q3 2019 business EPS(1) was stable at CER at €1.92.
- Q3 2019 IFRS EPS was €1.49, down 18.6% reflecting the capital
gain on the European generics divestment in Q3 2018.
- Sanofi expects 2019 business EPS(1) to grow approximately 5% at
CER(6) barring unforeseen major adverse events. Applying the
average October 2019 exchange rates, the currency impact on 2019
business EPS is estimated to be around +3%.
Key R&D and regulatory milestones achieved
- Dupixent® approved by European Commission for severe chronic
rhinosinusitis with nasal polyposis.
- Dupixent® approved by European Commission for adolescents with
moderate-to-severe atopic dermatitis.
- Dupixent® demonstrated positive topline phase 3 results in
children aged 6 to 11 years with severe atopic dermatitis.
- MenQuadfiTM, a meningococcal vaccine candidate, submitted in
EU.
- Flublok®, a quadrivalent influenza vaccine, submitted in EU.
|
Sanofi Chief Executive Officer,
Paul Hudson, commented:“Since joining Sanofi only two
months ago, I am increasingly excited about the strength of our
businesses, our ability to develop transformative medicines and the
diverse talent of our teams across the organization. Building on
this foundation, Sanofi delivered a resilient underlying
performance in the third quarter with strong sales in Specialty
Care, largely driven by the continued outstanding performance of
Dupixent®. I am encouraged by the organization’s early achievements
in our efficiency initiatives, which will allow us to further drive
innovation in our business. I’m looking forward to discussing
Sanofi‘s strategic priorities at our Capital Markets Day in
Cambridge, MA on December 10”. |
(1) In order to facilitate an understanding of
operational performance, Sanofi comments on the business net income
statement. Business net income is a non-GAAP financial measure (see
Appendix 8 for definitions). The consolidated income statement for
Q3 2019 is provided in Appendix 3 and a reconciliation of reported
IFRS net income to business net income is set forth in Appendix 4;
(2) including in Q2 2019 a €1.8 billion impairment charge mainly
related to Eloctate®; (3) Changes in net sales are expressed at
constant exchange rates (CER) unless otherwise indicated (see
Appendix 8); (4) Constant Structure: Adjusted for divestment of
European generics business and sales of Bioverativ products to
SOBI; (5) See definition page 9; (6) 2018 business EPS was
€5.47.
Investor Relations: (+) 33 1 53 77 45 45 -
E-mail: IR@sanofi.com - Media
Relations: (+) 33 1 53 77 46 46 - E-mail:
MR@sanofi.comWebsite: www.sanofi.com
Mobile app: SANOFI IR available on the App
Store and Google Play |
2019 third-quarter and first nine months
Sanofi sales
Unless otherwise indicated, all percentage
changes in sales in this press release are stated at CER(7). |
In the third quarter of 2019, Company sales were
€9,499 million, up 1.1% on a reported basis. Exchange rate
movements had a positive effect of 2.2 percentage points mainly
driven by the strength of the U.S. dollar which was partially
offset by the negative impact from the Argentine Peso. At CER,
Company sales decreased 1.1%.
First nine months Company sales reached €26,518
million, up 4.1% on a reported basis. Exchange rate movements had a
favorable effect of 1.9 percentage points. At CER, Company sales
were up 2.2%.
Global Business Units
The table below presents sales by Global
Business Unit (GBU). Please note that Emerging Markets sales for
Specialty Care and Primary Care are included in the China &
Emerging Markets GBU.
Net Sales by GBU
(€ million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Sanofi Genzyme (Specialty Care)(a) |
|
2,359 |
|
+19.5% |
6,670 |
+23.5%(c) |
Primary Care(a) |
|
2,185 |
|
-17.5%(d) |
6,751 |
-16.7%(e) |
China & Emerging Markets(b) |
|
1,890 |
|
+10.0% |
5,739 |
+9.1% |
Total
Pharmaceuticals |
|
6,434 |
|
+1.5% |
19,160 |
+2.1% |
Consumer Healthcare
(CHC) |
|
1,136 |
|
+0.4% |
3,535 |
+0.7% |
Sanofi Pasteur
(Vaccines) |
|
1,929 |
|
-9.8% |
3,823 |
+3.9% |
Total net sales |
|
9,499 |
|
-1.1% |
26,518 |
+2.2%(f) |
(a) Does not include China & Emerging Markets sales - see
definition page 10; (b) Includes Emerging Markets sales for Primary
Care and Specialty Care; (c) +19.2% at CS -Adjusted for Bioverativ
acquisition and sales of Bioverativ products to SOBI – see page 5;
(d) -12.7% at CS; (e) -11.6% at CS; (f) +3.2% at CS - Adjusted for
Bioverativ and sales of Bioverativ products to SOBI and European
Generics.
Global Franchises
The tables below present third-quarter and first
nine months 2019 sales by global franchise, including Emerging
Markets sales, to facilitate comparisons. Appendix 1 provides a
reconciliation of sales by GBU and franchise.
Net sales by Franchise (€
million) |
Q3 2019 |
Change at CER |
Developed Markets |
Change at CER |
EmergingMarkets |
Change at CER |
Specialty Care
franchises |
2,654 |
+19.8% |
2,359 |
+19.5% |
295 |
+21.9% |
Rare Disease |
774 |
+6.5% |
637 |
+2.8% |
137 |
+24.2% |
Multiple Sclerosis |
551 |
+2.1% |
534 |
+2.2% |
17 |
0.0% |
Oncology |
424 |
+9.2% |
297 |
+7.4% |
127 |
+13.5% |
Immunology |
619 |
+140.1% |
610 |
+138.8% |
9 |
ns |
Rare Blood Disorder |
286 |
-3.9%(1) |
281 |
-5.7%(2) |
5 |
ns |
Primary Care
franchises |
3,780 |
-8.3%(3) |
2,185 |
-17.5%(4) |
1,595 |
+7.9% |
Established Rx Products(5) |
2,371 |
-7.3%(6) |
1,207 |
-17.9%(7) |
1,164 |
+6.9% |
Diabetes |
1,261 |
-9.9% |
837 |
-17.7% |
424 |
+10.1% |
Cardiovascular |
148 |
-10.6% |
141 |
-12.2% |
7 |
+40.0% |
Consumer Healthcare |
1,136 |
+0.4% |
722 |
-3.3% |
414 |
+7.3% |
Vaccines |
1,929 |
-9.8% |
1,448 |
-15.2% |
481 |
+10.7% |
Total net sales |
9,499 |
-1.1%(8) |
6,714 |
-5.1%(9) |
2,785 |
+9.7% |
(1) +1.1% at CS- see page 5; (2) -0.7% at CS-
see page 5; (3) -5.0% at CS; (4 )-12.7% at CS; (5) including
Generics; (6) -1.8% at CS; (7) -8.9% at CS; (8) +0.5% at CS;(9)
-2.9% at CS
(7) See Appendix 8 for definitions of financial
indicators.
Net sales by Franchise (€
million) |
9M 2019 |
Change at CER |
Developed Markets |
Change at CER |
EmergingMarkets |
Change at CER |
Specialty Care
franchises |
7,601 |
+24.2%(1) |
6,670 |
+23.5% |
931 |
+28.5% |
Rare Disease |
2,350 |
+8.3% |
1,890 |
+3.2% |
460 |
+31.1% |
Multiple Sclerosis |
1,620 |
+3.5% |
1,563 |
+3.2% |
57 |
+12.5% |
Oncology |
1,254 |
+10.4% |
872 |
+6.7% |
382 |
+19.5% |
Immunology |
1,526 |
+158.9% |
1,507 |
+157.1% |
19 |
ns |
Rare Blood Disorder |
851 |
+33.0%(2) |
838 |
+30.8%(3) |
13 |
ns |
Primary Care
franchises |
11,559 |
-8.4%(4) |
6,751 |
-16.7%(5) |
4,808 |
+5.8% |
Established Rx Products(6) |
7,283 |
-8.9%(7) |
3,789 |
-18.3%(8) |
3,494 |
+3.7% |
Diabetes |
3,845 |
-7.9% |
2,551 |
-15.6% |
1,294 |
+11.2% |
Cardiovascular |
431 |
-4.6% |
411 |
-6.6% |
20 |
+66.7% |
Consumer Healthcare |
3,535 |
+0.7% |
2,308 |
-1.7% |
1,227 |
+5.2% |
Vaccines |
3,823 |
+3.9% |
2,550 |
-5.6% |
1,273 |
+28.7% |
Total net sales |
26,518 |
+2.2%(9) |
18,279 |
-1.6%(10) |
8,239 |
+11.1% |
(1) +20.4 % at CS- Adjusted for Bioverativ and
sales of products to SOBI – see page 5; (2) +1.5% at CS- see page
5; (3) -0.1% at CS -see page 5; (4) -5.0% at CS; (5) -11.6% at CS;
(6) including Generics; (7) -3.4% at CS; (8) -9.2% at CS; (9) +3.2%
at CS- Adjusted for Bioverativ and sales of Bioverativ products to
SOBI and European Generics;(10) -0.1% at CS - Adjusted for
Bioverativ and sales of Bioverativ products to SOBI and European
Generics
Pharmaceuticals
Third-quarter Pharmaceutical sales were up 1.5%
(up 4.1% at CS) to €6,434 million mainly driven by Dupixent® which
was partially offset by Diabetes and Established Rx Products
including the disposal of the European generics business at the end
of third-quarter 2018. First nine months sales for Pharmaceuticals
increased 2.1% (up 3.6% at CS) to €19,160 million.
Specialty Care franchises
Immunology franchise
Net sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Dupixent® |
570 |
+142.2% |
1,395 |
+160.6% |
Kevzara® |
49 |
+118.2% |
131 |
+142.3% |
Total
Immunology |
619 |
+140.1% |
1,526 |
+158.9% |
Dupixent® (collaboration with
Regeneron) generated sales of €570 million in the third quarter (up
142%). In the U.S., Dupixent® sales of €455 million (up 130%) were
driven by continued growth in atopic dermatitis which benefited
from launch in the adolescent age group (12 to 17 years of age) in
mid-March, rapid uptake in asthma and launch in chronic
rhinosinusitis with nasal polyposis (approved in the U.S. in June).
Dupixent® U.S. NBRx and TRx were respectively up 15% and 21%
sequentially. In Europe, third-quarter sales were €54 million (up
170%). In Rest of the World region, Dupixent® sales were €52
million (up 243%) mainly generated in Japan. Dupixent® is now
launched in 30 countries, 7 of which have multiple indications
launched. First nine months Dupixent® sales increased 161% to
€1,395 million. Long term 76 week data was recently published in
the Journal of the American Academy of Dermatology with a safety
profile that was consistent with previous clinical trials and
sustained efficacy. This data is supportive of continuous long term
use of Dupixent®.
Kevzara® (collaboration with
Regeneron) sales were €49 million (up 118%) in the third quarter,
of which €33 million was in the U.S. (up 78%) reflecting increased
adoption and category share. First nine months Kevzara® sales
increased 142% to €131 million.
Multiple Sclerosis
franchise
Net sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Aubagio® |
494 |
+12.4% |
1,397 |
+11.7% |
Lemtrada® |
57 |
-42.4% |
223 |
-28.4% |
Total Multiple
Sclerosis |
551 |
+2.1% |
1,620 |
+3.5% |
Third-quarter Multiple
Sclerosis (MS) sales increased 2.1% to €551 million,
driven by double-digit growth of Aubagio® in the U.S. and Europe,
partially offset by lower Lemtrada® sales. First nine months MS
sales increased 3.5% to €1,620 million.
Third-quarter Aubagio® sales
increased 12.4% to €494 million, supported by the U.S. performance
(up 13.8% to €363 million) and Europe (up 10.8% to €103 million).
First nine months Aubagio® sales increased 11.7% to €1,397
million.Beginning January 1, 2020, Aubagio® will be excluded from
the ESI National Preferred Formulary.
In the third quarter, Lemtrada®
sales decreased 42.4% to €57 million due to lower U.S. sales (down
33.3% to €34 million) and European sales (down 60.5% to €15
million), reflecting increased global competition and the update to
the EU label. First nine months Lemtrada® sales decreased 28.4% to
€223 million.
On October 30, 2019, Sanofi entered into an
agreement to settle, without any admission of liability or
wrongdoing, the previously disclosed action initiated against
Sanofi by the Trustee relating to Sanofi’s publicly-traded
Contingent Value Rights. As part of the settlement agreement,
Sanofi will pay a total of $315 million. The settlement agreement
is subject to, among other things, final court approval
Oncology franchise
Net sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Jevtana® |
119 |
+8.5% |
356 |
+11.7% |
Thymoglobulin® |
90 |
+18.7% |
265 |
+17.8% |
Eloxatin® |
52 |
+6.1% |
161 |
+15.1% |
Mozobil® |
50 |
+14.3% |
143 |
+11.3% |
Taxotere® |
42 |
-4.5% |
131 |
+0.8% |
Zaltrap® |
26 |
+13.6% |
71 |
+2.9% |
Others |
45 |
+4.8% |
127 |
+1.7% |
Total
Oncology |
424 |
+9.2% |
1,254 |
+10.4% |
Third-quarter Oncology sales
increased 9.2% to €424 million driven by Emerging Markets (up 13.5%
to €127 million) and the U.S. (up 9.7% to €152 million). First nine
months Oncology sales increased 10.4% to €1,254 million.
Third-quarter Jevtana® sales
increased 8.5% to €119 million driven by the U.S. and Japan. First
nine months Jevtana® sales were up 11.7% to €356 million. In the
third quarter, Thymoglobulin® sales increased
18.7% to €90 million, reflecting the performance in Emerging
Markets. Over the period, Eloxatin® sales grew
6.1% to €52 million driven by China. First nine months sales of
Thymoglobulin® and Eloxatin® increased 17.8% (to €265 million) and
15.1% (to €161 million), respectively.
Libtayo® (collaboration with
Regeneron) was approved in the U.S. in September 2018 for the
treatment of patients with metastatic cutaneous squamous cell
carcinoma (CSCC) or locally advanced CSCC who are not candidates
for curative surgery or curative radiation. U.S. Libtayo® sales are
reported by Regeneron. Libtayo® was approved in Brazil at the end
of March and in Canada in April. In late June, Libtayo® was
approved in the European Union for adult patients with metastatic
or locally advanced CSCC who are not candidates for curative
surgery or curative radiation and launched in July in the UK,
Germany, and Austria. Ex-U.S. Libtayo® sales were €4 million in the
third quarter.
Rare Disease franchise
Net sales (€ million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Myozyme® / Lumizyme® |
226 |
+7.7% |
680 |
+9.8% |
Fabrazyme® |
202 |
+3.7% |
598 |
+6.4% |
Cerezyme® |
168 |
+6.7% |
531 |
+6.1% |
Aldurazyme® |
49 |
0.0% |
170 |
+12.5% |
Cerdelga® |
53 |
+26.8% |
151 |
+27.8% |
Others Rare Disease |
76 |
+2.8% |
220 |
+0.5% |
Total Rare Disease |
774 |
+6.5% |
2,350 |
+8.3% |
In the third quarter, Rare
Disease sales increased 6.5% to €774 million, driven by
Emerging Markets (up 24.2% to €137 million). In the U.S.,
third-quarter Rare Disease sales grew 4.8% to €298 million. In
Europe, over the period, sales increased 4.1% to €253 million.
First nine months Rare Disease sales increased 8.3% to €2,350
million.
Third-quarter Gaucher
(Cerezyme® and Cerdelga®) sales were up 10.7% to
€221 million, supported by the increasing penetration of Cerdelga®
in Europe and the U.S. and the sustained growth of Cerezyme® in
Emerging Markets. Third-quarter Cerdelga® sales increased 26.8% to
€53 million, with sales up 53.8% in Europe (to €19 million) and up
12.0% in the U.S. (to €30 million). First nine months Gaucher sales
were €682 million, up 10.1%.
Third-quarter Pompe
(Myozyme®/Lumizyme®)
sales grew 7.7% to €226 million, supported by positive trends in
naïve patient accruals. This performance was driven by the U.S. (up
8.3% to €81 million) and Emerging Markets (up 18.8% to €34
million). First nine months Myozyme®/Lumizyme® sales increased 9.8%
to €680 million.
Third-quarter Fabry
(Fabrazyme®) sales grew 3.7% to €202 million,
driven by Emerging Markets (up 33.3% to €22 million) and Europe (up
7.0% to €46 million). Over the period, U.S. sales were stable at
€105 million. First nine months Fabrazyme® sales were up 6.4% to
€598 million.
Rare Blood Disorder franchise
Net sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Eloctate® |
162 |
-20.2%* |
507 |
+15.8%* |
Alprolix® |
104 |
+12.5%** |
304 |
+51.1%** |
Cablivi® |
20 |
- |
40 |
- |
Total
Rare Blood Disorder |
286 |
-3.9%*** |
851 |
+33.0%*** |
*-17.6% at CS in Q3 2019 and -11.2% in 9M 2019 at CS - see
footnotes 8 and 9; **+23.8% at CS in Q3 2019 and +13.9% at CS in 9M
2019 – see footnotes 8 and 9;*** +1.1% at CS in Q3 2019 and +1.5%
in 9M 2019 at CS - see footnotes 8 and 9
Bioverativ was consolidated in Sanofi’s
Financial Statements from March 9, 2018. Third-quarter sales of the
Rare Blood Disorder franchise were €286 million, up 1.1% at CS(8).
Third-quarter U.S. sales were €214 million, down 5.6%. Non U.S.
sales were €72 million with Japan as the primary contributor. First
nine months sales of the Rare Blood Disorder franchise were €851
million, up 1.5% at CS(9).
Eloctate® sales were €162
million in the third quarter, down 17.6% at CS(8). In the U.S.,
sales of the product decreased 23.5% to €122 million, reflecting
ongoing competitive pressure. In the Rest of the World region,
third-quarter Eloctate® sales decreased 8.6% at CS(8) to €35
million. First nine months Eloctate® sales were €507 million, down
11.2% at CS(9).
Alprolix® sales were €104
million in the third quarter, up 23.8% at CS(8). In the U.S., sales
of the product increased 17.5% to €79 million. In the Rest of
the World region, Alprolix® sales increased 47.1% at CS(8) to €25
million due to growth in product sales to SOBI and Japan. First
nine months Alprolix® sales were €304 million, up 13.9% at
CS(9).
Cablivi® for the treatment of
adults with acquired thrombotic thrombocytopenic purpura (aTTP)
generated third-quarter sales of €20 million. In the U.S., where
Cablivi® was launched in April, sales were €13 million. In Europe,
where the product is commercially available in Germany, Denmark,
Austria, Belgium and the Netherlands, sales were €6 million.
Cablivi® has a temporary license to be sold in France. First nine
months Cablivi® sales were €40 million.
Primary Care franchises
Cardiovascular franchise
Net sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Praluent® |
61 |
-11.8% |
183 |
-0.6% |
Multaq® |
87 |
-9.7% |
248 |
-7.5% |
Total
cardiovascular franchise |
148 |
-10.6% |
431 |
-4.6% |
Third-quarter Praluent®
(collaboration with Regeneron) sales decreased 11.8% to €61
million, reflecting lower sales in the U.S. (down 31.7% to €29
million) which were impacted by significantly higher rebates. In
Europe, Praluent® sales increased 4.5% to €22 million despite the
suspension of sales in Germany in August following the Regional
Court of Dusseldorf ruling in the ongoing patent litigation. First
nine months Praluent® sales decreased 0.6% to €183 million. In
August, the U.S. District Court for the District of Delaware ruled
in favor of Sanofi and Regeneron in the ongoing Praluent®
(alirocumab) patent litigation. The Court found as a matter of law
that Amgen’s asserted patent claims for antibodies targeting PCSK9
(proprotein convertase subtilisin/kexin type 9) are invalid based
on lack of enablement. U.S. payer coverage for Praluent® in 2020 is
expected to be lower for insured lives across Medicare plans.
(8) Sales of products to SOBI were initially
recorded in “other revenues” in H1 2018” and in sales from H2 2018;
the H1 2018 reclassification was reflected in Q3 2018. H1 2018 and
Q3 2018 sales were adjusted accordingly for calculation of CS.
Unaudited data.(9) Growth comparing first nine months 2019 sales
versus full first nine months 2018 sales at CER. Sales of products
to SOBI were initially recorded in “other revenues” in H1 2018” and
in sales from H2 2018; the H1 2018 reclassification was reflected
in Q3 2018. H1 2018 and Q3 2018 sales were adjusted accordingly for
calculation of CS. Unaudited data.
Diabetes franchise
Net sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Lantus® |
751 |
-17.5% |
2,283 |
-17.0% |
Toujeo® |
218 |
0.0% |
649 |
+1.4% |
Total glargine |
969 |
-14.1% |
2,932 |
-13.5% |
Amaryl® |
84 |
-8.0% |
255 |
-2.7% |
Apidra® |
83 |
-2.4% |
256 |
-4.1% |
Admelog® |
51 |
+84.6% |
194 |
ns |
Soliqua® |
33 |
+55.0% |
83 |
+71.7% |
Insuman® |
19 |
-4.8% |
62 |
-5.9% |
Total Diabetes |
1,261 |
-9.9% |
3,845 |
-7.9% |
In the third quarter, global
Diabetes sales decreased 9.9% to €1,261 million,
due to lower glargine (Lantus® and Toujeo®) sales in the U.S.
Third-quarter U.S. Diabetes sales were down 24.7% to €451 million,
reflecting the increased contribution to the coverage gap related
to Medicare Part D and a continued decline in average U.S. glargine
net prices. Third-quarter sales in Emerging Markets increased 10.1%
to €424 million. Third-quarter sales in Europe decreased 3.0% to
€295 million despite Toujeo® growth (up 18.3% to €84 million).
First nine months global Diabetes sales decreased 7.9% to €3,845
million. Broad U.S. payer coverage for key Diabetes brands is
expected to be largely maintained in 2020.
In the third quarter, Lantus®
sales were €751 million, down 17.5%. In the U.S., Lantus® sales
decreased 32.5% to €295 million, mainly reflecting lower average
net price and the increased contribution to the coverage gap
related to Medicare Part D. In Europe, third-quarter Lantus® sales
were €140 million, down 13.0% due to biosimilar glargine
competition and patients switching to Toujeo®. In Emerging Markets,
third-quarter Lantus® sales were up 9.5% to €264 million. First
nine months Lantus® sales decreased 17.0% to €2,283 million.
Third-quarter Toujeo® sales
were stable at €218 million. In the U.S., third-quarter Toujeo®
sales were €73 million, down 25.0% mainly reflecting lower average
net price and the increased contribution to the coverage gap
related to Medicare Part D. In Europe and Emerging Markets,
third-quarter Toujeo® sales were €84 million (up 18.3%) and €43
million (up 26.5%), respectively. First nine months Toujeo® sales
increased 1.4% to €649 million.
Third-quarter and first nine months
Amaryl® sales were €84 million (down 8.0%) and
€255 million (down 2.7%), respectively.
Third-quarter Apidra® sales
decreased 2.4% to €83 million. Lower sales in the U.S. (down 35.3%
to €11 million) offset growth in Emerging Markets (up 23.1% to €32
million). First nine months Apidra® sales were €256 million, down
4.1%.
Admelog® (insulin lispro
injection) generated sales of €51 million (up 85%) in the third
quarter. Admelog® sales in the U.S. were €47 million, up 80% versus
the third quarter of 2018, but down 34% versus the second quarter
of 2019 due to the WAC price adjustment of -44% which took effect
on July 1. First nine months Admelog® sales were €194 million
versus €36 million in the same period of 2018.
Third-quarter and first nine months
Soliqua® 100/33 (insulin glargine 100 Units/mL
& lixisenatide 33 mcg/mL injection) and
Suliqua™ sales increased 55% (to €33 million) and
72% (to €83 million), respectively.
Established Rx Products
Net sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Lovenox® |
334 |
-5.4% |
1,024 |
-8.5% |
Plavix® |
356 |
-0.6% |
1,122 |
-0.4% |
Aprovel®/Avapro® |
169 |
+5.7% |
543 |
+7.2% |
Synvisc® /Synvisc-One® |
73 |
-2.8% |
228 |
-6.5% |
Renvela®/Renagel® |
84 |
-28.9% |
229 |
-29.8% |
Myslee®/Ambien®/Stilnox® |
56 |
-1.8% |
163 |
-8.1% |
Allegra® |
18 |
-5.6% |
100 |
-3.1% |
Generics |
268 |
-32.1% |
804 |
-33.9% |
Other |
1,013 |
-1.2% |
3,070 |
-3.3% |
Total Established Rx
Products |
2,371 |
-7.3% |
7,283 |
-8.9% |
In the third quarter, Established Rx
Products sales decreased 7.3% to €2,371 million, primarily
reflecting the divestment of the European generics business Zentiva
at the end of the third quarter of 2018. Excluding the generics
divestment, Established Rx Products sales decreased 1.8% in the
third quarter, reflecting generic competition to Renvela®/Renagel®
(sevelamer) in the U.S. and lower Lovenox sales in Europe®. First
nine months Established Rx Products sales decreased 8.9% to €7,283
million (down 3.4% at CS).
Third-quarter Lovenox® sales
decreased 5.4% to €334 million, reflecting lower Mature Markets
sales (down 16.2% to €191 million) due to biosimilar competition in
several countries in Europe. In Emerging Markets, Lovenox® sales
grew 14.6% to €143 million. First nine months Lovenox® sales were
down 8.5% to €1,024 million.
In the third quarter, Plavix®
sales decreased 0.6% to €356 million due to generic competition in
Japan (sales down 23.1% to €32 million). In China, Plavix® sales
increased 3.5% to €209 million despite the implementation of the
volume based procurement program (VBP) in key cities in China at
the beginning of the second quarter. First nine months Plavix®
sales decreased 0.4% to €1,122 million.
Third-quarter Aprovel®/Avapro®
sales increased 5.7% to €169 million driven by Emerging Markets
sales (up 3.6% to €117 million). In China, Aprovel®/Avapro® sales
were up 1.4% to €74 million despite the implementation of the VBP
in key cities in China at the beginning of the second quarter.
First nine months Aprovel®/Avapro® sales increased 7.2% to €543
million.
In September 2019, Plavix® and Co-Aprovel® were
among the bidding winners of the nationwide VBP program. Sanofi
expects the nationwide implementation of the VBP program to begin
in December. As a result, Q4 2019 sales of Plavix® and Aprovel®
family products are expected to decrease significantly due to net
price adjustments of inventory in the channel. In 2020, Sanofi
expects sales of Plavix® and the Aprovel® family in China to
decline around 50%.
Third-quarter Renvela®/Renagel®
(sevelamer) sales decreased 28.9% to €84 million, due to generic
competition in the U.S. (down 50.7% to €39 million) and despite
growth in China. First nine months Renvela®/Renagel® sales
decreased 29.8% to €229 million.
In the third quarter, Generics
sales decreased 32.1% to €268 million, reflecting the divestment of
the European generics business Zentiva at the end of the third
quarter of 2018. At CS, third-quarter Generics sales increased
7.9%, reflecting 6.8% growth in Emerging Markets (€176 million).
First nine months Generics sales were €804 million, down 33.9% and
up 5.4% at CS.
Consumer Healthcare
CHC sales by geography and category are provided
in Appendix 1.
Net sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Allergy Cough & Cold |
287 |
+1.4% |
898 |
+2.3% |
of which Allegra® |
98 |
+8.0% |
341 |
+3.5% |
of which Mucosolvan® |
28 |
-16.1% |
71 |
-12.5% |
of which Xyzal® |
12 |
+10.0% |
39 |
+19.4% |
Pain |
300 |
+3.8% |
930 |
+2.6% |
of which Doliprane® |
73 |
-2.7% |
229 |
-3.0% |
of which Buscopan® |
41 |
+14.6% |
139 |
+7.6% |
Digestive |
229 |
-4.7% |
777 |
+4.7% |
of which Dulcolax® |
55 |
+3.8% |
171 |
+5.0% |
of which Enterogermina® |
54 |
+26.2% |
169 |
+23.5% |
of which Essentiale® |
42 |
0.0% |
141 |
+8.5% |
of which Zantac® |
14 |
-58.1% |
83 |
-16.1% |
Nutritionals |
178 |
+1.8% |
492 |
-3.0% |
Other |
142 |
-2.1% |
438 |
-8.5% |
of which Gold Bond® |
49 |
+2.1% |
149 |
-2.1% |
Total Consumer
Healthcare |
1,136 |
+0.4% |
3,535 |
+0.7% |
In the third quarter, Consumer
Healthcare (CHC) sales increased 0.4% to €1,136 million,
with growth coming from the Pain, Nutritionals, and Allergy, Cough
& Cough categories, supported by performance in Emerging
Markets (up 7.3% to €414 million). In the first nine months, CHC
sales grew 0.7% to €3,535 million. Strengthening of regulatory
requirements, particularly in Europe, as well as the continued
effect of non-core divestments impacted growth in the third
quarter. These factors are expected to have a dampening effect on
CHC performance during the remainder of the year and through the
first part of 2020. Additionally, in October Sanofi decided to
conduct a precautionary voluntary recall of Zantac® in the U.S. and
Canada. In September, the U.S. Food and Drug Administration (FDA)
and Health Canada issued public statements alerting that some
ranitidine medicines, including Zantac OTC, could contain NDMA at
low levels and asked manufacturers to conduct testing. Evaluations
are ongoing on both drug substance (active ingredient) and finished
drug product. Due to inconsistencies in preliminary test results of
the active ingredient used in the U.S. and Canadian products,
Sanofi decided to conduct the voluntary recall in the U.S. and
Canada as the investigation continues. In the third quarter,
Zantac® sales were down 58.1% to €14 million, reflecting the impact
of this recall.
In Europe, third-quarter CHC
sales decreased 7.0% to €306 million reflecting divestments of
non-strategic brands and strengthening regulatory requirements.
First nine months CHC sales in Europe were down 4.5% to €986
million.
In the U.S., third-quarter CHC
sales decreased 4.4% to €252 million, reflecting the impact of the
Zantac® recall. First nine months CHC sales in the U.S. were down
0.4% to €840 million.
In Emerging Markets,
third-quarter CHC sales increased 7.3% to €414 million, driven by
performance in Latin America. First nine months CHC sales in
Emerging Markets increased 5.2% to €1,227 million.
Vaccines
Net sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
Influenza vaccines(incl. Vaxigrip®,
Fluzone HD® & Fluzone®) |
735 |
-28.5% |
852 |
-25.9% |
Polio/Pertussis/Hib vaccines (incl.
Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®) |
515 |
-1.2% |
1,503 |
+19.3% |
Meningitis/Pneumo vaccines (incl.
Menactra®) |
310 |
+8.8% |
558 |
+12.3% |
Adult Booster vaccines (incl. Adacel
®) |
182 |
+17.4% |
416 |
+20.0% |
Travel and other endemic vaccines |
159 |
+20.8% |
416 |
+14.2% |
Other vaccines |
28 |
+33.3% |
78 |
+19.4% |
Total Vaccines |
1,929 |
-9.8% |
3,823 |
+3.9% |
Third-quarter Vaccines sales
decreased 9.8% to €1,929 million. This anticipated decrease was
impacted by the timing of flu vaccine delivery in the U.S. which
will be significantly weighted towards the fourth quarter due to
the roughly one-month delay in strain selection by the WHO at the
beginning of the year. As a consequence, U.S. third-quarter
Vaccines sales were down 19.5% to €1,122 million. In Emerging
Markets and Europe, third-quarter Vaccines sales were up 10.7% (to
€481 million) and up 7.8% (to €235 million), respectively. First
nine months Vaccines sales were up 3.9% to €3,823 million.
In the third quarter,
Polio/Pertussis/Hib (PPH) vaccines sales decreased
1.2% to €515 million, reflecting CDC inventory variation in the
U.S. (down 37.8% to €78 million) which offset the strong
performance in Emerging Markets (up 18.2% to €330 million). In
Europe, PPH vaccines sales were stable at €73 million. First nine
months PPH vaccines sales were up 19.3% to €1,503 million.
Influenza vaccines sales
decreased 28.5% to €735 million in the third quarter, reflecting
lower sales in the U.S. (down 32.6% to €580 million) due to the
aforementioned delay in delivery. As already announced, Sanofi
expects influenza vaccine sales to be significantly weighted
towards the fourth quarter. First nine months influenza vaccines
sales were down 25.9% to €852 million. Sanofi expects full-year
2019 influenza vaccines sales to exceed the prior year level,
driven by its differentiated portfolio.
Third-quarter Menactra® sales
increased 8.8% to €310 million, driven by the U.S. First nine
months Menactra® sales increased 12.3% to €558 million.
Third-quarter Travel and other endemic
vaccines sales were €159 million up 20.8%, supported by
favorable phasing of yellow fever vaccine sales. First nine months
Travel and other endemic vaccines sales were up 14.2% to €416
million.
Third-quarter Adult Booster
vaccines sales were up 17.4% to €182 million, reflecting strong
demand for Repevax® in Europe and favorable phasing for Adacel® in
the U.S. First nine months Adult Booster vaccines sales increased
20.0% to €416 million.
Company sales by geographic
region
Sanofi sales (€
million) |
Q3 2019 |
Change at CER |
9M 2019 |
Change at CER |
United States |
3,671 |
-4.5% |
9,072 |
+2.4% |
Emerging Markets(a) |
2,785 |
+9.7% |
8,239 |
+11.1% |
of which Asia |
1,172 |
+10.8% |
3,510 |
+14.0% |
of which Latin America |
685 |
+21.4% |
1,990 |
+12.6% |
of which Africa, Middle East |
564 |
-8.0% |
1,673 |
+1.2% |
of which Eurasia(b) |
318 |
+13.5% |
952 |
+16.3% |
Europe(c) |
2,157 |
-7.5% |
6,508 |
-8.1% |
Rest of the
World(d) |
886 |
-1.7% |
2,699 |
+3.5% |
of which Japan |
456 |
+2.2% |
1,453 |
+5.9% |
Total Sanofi sales |
9,499 |
-1.1% |
26,518 |
+2.2% |
- World excluding U.S., Canada, Western & Eastern Europe
(except Eurasia), Japan, South Korea, Australia, New Zealand and
Puerto Rico
- Russia, Ukraine, Georgia, Belarus, Armenia and Turkey
- Western Europe + Eastern Europe except Eurasia
- Japan, South Korea, Canada, Australia, New Zealand, Puerto
Rico
Third-quarter sales in the U.S.
decreased 4.5% to €3,671 million, reflecting the expected delay in
flu vaccines supply which offset Dupixent® performance. In the
U.S., first nine months sales increased 2.4% to €9,072 million.
Third-quarter sales in Emerging
Markets grew 9.7% to €2,785 million, driven by Established
Products (up 6.9%), Vaccines (up 10.7%), Diabetes (up 10.1%) and
Rare Disease (up 24.2%). In Asia, third-quarter sales were up 10.8%
to €1,172 million. In China, sales increased 13.7% to €744 million,
driven by Pharmaceuticals and Vaccines. In Latin America,
third-quarter sales increased 21.4% to €685 million. Third-quarter
sales in Brazil were up 10.5% to €261 million. In Africa and the
Middle East region, third-quarter sales were €564 million, down
8.0% reflecting order phasing in the Middle East. Third-quarter
sales in the Eurasia region increased 13.5% to €318 million,
supported by strong growth in Turkey. Third-quarter sales in Russia
were €166 million up 9.0%. In Emerging Markets, first nine months
sales increased 11.1% to €8,239 million.
Third-quarter sales in Europe
were €2,157 million, down 7.5% reflecting divestment of the
European generics business. At CS, third-quarter sales decreased
1.5% mainly reflecting lower Lovenox®, Lemtrada® and CHC sales
which were partially offset by Dupixent® and Vaccines performance.
In Europe, first nine months sales decreased 8.1% (-1.8% at CS) to
€6,508 million.
Sales in Japan increased 2.2%
to €456 million in the third quarter, driven by Dupixent® which
largely offset lower sales of Plavix® due to generic competition.
In Japan, first nine months sales increased 5.9% to €1,453
million.
R&D update
Consult Appendix 6
for full overview of Sanofi’s R&D pipeline |
Regulatory update
Regulatory updates since July 29, 2019 include
the following:
- In October, the European Commission approved
Dupixent® (collaboration with Regeneron) as an
add-on therapy with intranasal corticosteroids for the treatment of
adults with severe chronic rhinosinusitis with nasal polyposis
(CRSwNP) for whom therapy with systemic corticosteroids and/or
surgery do not provide adequate disease control.
- In October, MenQuadfiTM, a meningococcal
quadrivalent conjugate vaccine, was submitted in the European Union
for the prevention of invasive meningococcal disease in individuals
12 months of age and older.
- In October, a quadrivalent recombinant influenza vaccine was
submitted in the European Union for the prevention of influenza
disease in persons 18 years of age and older (vaccine registered in
the U.S. under the trade name Flublok®).
- In August, Dupixent® was approved by the
European Commission for adolescents 12 to 17 years of age with
moderate-to-severe atopic dermatitis who are candidates for
systemic therapy.
At the end of October 2019, the R&D pipeline
contained 85 projects, including 37 new molecular entities in
clinical development (or that have been submitted to the regulatory
authorities). 34 projects are in phase 3 or have been submitted to
the regulatory authorities for approval.
Portfolio update
Phase 3:
- In September, the findings from the CARD study of
Jevtana® (cabazitaxel) were presented at the 2019
European Society of Medical Oncology (ESMO) Congress. Data were
also published in the New England Journal of Medicine and showed
that patients with metastatic castration-resistant prostate cancer
(mCRPC) previously treated with docetaxel and who progressed within
12 months on an androgen receptor targeted agent (abiraterone or
enzalutamide) experienced significantly longer radiographic
progression free survival (rPFS) with Jevtana® plus prednisone
compared with abiraterone plus prednisone or enzalutamide. Overall
survival (OS) with Jevtana® was also significantly longer.
- In August, positive topline phase 3 results for
Dupixent® in children aged 6 to 11 years with
severe atopic dermatitis were announced.
Phase 2
- In the third quarter, the NSCLC and
Prostate Cancer combination cohorts with cemiplimab and
isatuximab were discontinued due to efficacy
considerations. This decision was not safety related. The ongoing
combination trials in Multiple Myeloma and Lymphoma as well as
combination trials with isatuximab and atezolizumab in solid tumors
continue.
Phase 1:
- A phase 1 trial evaluating SAR442085, an
anti-CD38 monoclonal antibody, was initiated in multiple
myeloma.
- SAR443122, a RIPK1 inhibitor (collaboration
with Denali) entered into phase 1.
- BIVV020, a complement C1s inhibitor, entered
phase 1.
- The combination SAR442720 (SHP2 inhibitor) and
cobimetinib entered phase 1.
- SAR441255, a trigonal GLP1R/GIPR/GCGR agonist
was discontinued.
Collaboration
In September, Sanofi and Abbott announced a
partnership to integrate glucose sensing and insulin delivery
technologies that would help to further simplify how people with
diabetes manage their condition.
Corporate Social
Responsibility
Sanofi’s commitment to good corporate
citizenship is rooted in its heritage. The company recognizes that
its core business creates value for society, and it works to ensure
that the benefits of this societal value are accessible to as many
people around the world as possible. The company also has a
longstanding commitment to the communities where it operates and to
minimizing its impact on the environment.
Sanofi’s corporate social responsibility (CSR)
approach was recognized during the third quarter of 2019 by the Dow
Jones Sustainability Index (DJSI) for the 13th consecutive year. In
2019, Sanofi ranked as the third most sustainable pharmaceutical
company with a score of 82 out of 100, up from 76 last year. The
DJSI selects the best companies in each sector based on economic,
social and environmental performance.
On October 15, 2019, Sanofi opened a
digitally-enabled manufacturing facility in Framingham, one of the
first of its kind, to develop transformative treatments for
patients while significant reducing environmental waste. The
facility will produce 80% less CO2 emissions compared to
traditional technologies and reduce water and chemical usage by 91%
and 94% respectively.
2019 third-quarter and first nine months
financial results(10)
Business Net Income(10)
In the third quarter of 2019, Sanofi generated
net sales of €9,499 million, an increase of 1.1%
(down 1.1% at CER). First nine months sales were €26,518 million,
up 4.1% on a reported basis (up 2.2% at CER).
Third-quarter other revenues
increased 19.9% (up 14.8% at CER) to €422 million, reflecting the
VaxServe sales contribution of non-Sanofi products (€372 million,
up 18.7% at CER). First nine months other revenues increased 23.8%
(up 17.2% at CER) to €1,096 million, driven by the VaxServe sales
contribution of non-Sanofi products (€915 million, up 24.0% at CER)
and the consolidation of collaboration revenues from Swedish Orphan
Biovitrum AB (SOBI).
Third-quarter Gross Profit
increased 0.9% to €6,787 million (down 1.8% at CER). The gross
margin ratio decreased 0.2 percentage points to 71.4% (71.2% at
CER) versus the third quarter of 2018. The favorable effects from
Dupixent® and the divestment of the European generics business were
more than offset by the negative impact from U.S. Diabetes net
price evolution, the decline in Established Rx Products sales in
Mature Markets as well as the impact of Vaccines and the Zantac®
recall. In the third quarter of 2019, the gross margin ratio of
segments were 74.8% for Pharmaceuticals (up 1.2 percentage points),
64.8% for CHC (down 2.0 percentage points) and 67.4% for Vaccines
(down 2.7 percentage points). First nine months Gross Profit
increased 5.1% to €19,095 million (up 2.8% at CER). In the first
nine months of 2019, the gross margin ratio increased 0.7
percentage points to 72.0% (71.8% at CER) versus the same period of
2018. Sanofi expects its full-year 2019 gross margin ratio to be
between 70% and 71% at CER.
Research and Development
(R&D) expenses decreased 6.8% to €1,362 million in the third
quarter of 2019. At CER, R&D expenses decreased 8.1%,
reflecting favorable phasing of expenses, lower research costs
resulting from restructuring of the immuno-oncology collaboration
with Regeneron as well as a €45 million payment from SOBI related
to the BIV001 opt-in. In the third quarter, the ratio of R&D to
sales decreased 1.3 percentage points to 14.3% compared to the
third quarter of 2018. First nine months R&D expenses increased
2.8% to €4,335 million (up 0.5% at CER). In the first nine months
of 2019, the ratio of R&D to sales was 0.3 percentage points
lower at 16.3% compared to the same period of 2018.
Third-quarter selling general and
administrative expenses (SG&A) increased 0.6% to
€2,314 million. At CER, SG&A expenses were down 1.5%,
reflecting cost efficiency measures notably in Primary Care in
Mature Markets and support functions as well as the impact of the
European generics disposal which more than offset increased
investments in Specialty Care. In the third quarter, the ratio of
SG&A to sales decreased 0.1 percentage points to 24.4% compared
to the third quarter of 2018. First nine months SG&A expenses
increased 0.6% to €7,156 million (down 1.4% at CER). In the first
nine months of 2019, the ratio of SG&A to sales was 0.9
percentage points lower at 27.0% compared to the same period of
2018.
Third-quarter operating
expenses were €3,676 million, a decrease of 2.3% and 4.1%
at CER. Excluding the payment from SOBI and the disposal of
European generics business, operating expenses decreased 1.9% at
CER in the third quarter. First nine months operating expenses were
€11,491 million, an increase of 1.5% and down 0.7% at CER.
Third-quarter other current operating
income net of expenses was -€119 million versus -€74
million in the third quarter of 2018. This line includes 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. This line also includes the share of profit/loss related
to the immuno-oncology Alliance. In the third quarter of 2019, a
total of €23 million of capital gains on non-strategic CHC brand
disposals was also recorded. First nine months other current
operating income net of expenses was -€312 million versus €84
million in the same period of 2018.
The share of profits from associates was €132
million in the third quarter versus €153 million for the same
period of 2018, mainly reflecting the share of profits in
Regeneron. In the first nine months, the share of profits from
associates was broadly stable at €301 million versus the same
period of 2018.
In the third quarter, non-controlling
interests were -€12 million versus -€26 million in the
third quarter of 2018, reflecting the end of non-controlling
interests related to the Alliance with Bristol-Myers Squibb on
Plavix® and Avapro®. First nine months non-controlling interests
were -€27 million versus -€84 million for the same period of
2018.
Third-quarter business operating
income increased 3.1% to €3,112 million. At CER, business
operating income decreased 0.9%. The ratio of business operating
income to net sales increased 0.7 percentage points to 32.8% versus
the third quarter of 2018. Over the period, the business operating
income ratio of segments were 39.0% for Pharmaceuticals (up 3.4
percentage points), 32.0% for CHC (down 1.2 percentage points) and
50.0% for Vaccines (down 5.3 percentage points).
(10) See Appendix 3 for 2019 third-quarter
consolidated income statement; see Appendix 8 for definitions of
financial indicators, and Appendix 4 for reconciliation of IFRS net
income reported to business net income.
First nine months business operating income was
€7,566 million, up 5.9% (up 3.7% at CER). In the first nine months
of 2019, the ratio of business operating income to net sales
increased 0.4 percentage points to 28.5%.
Net financial expenses were
-€71 million in the third quarter versus -€106 million in the same
period of 2018, reflecting lower cost of net debt. First nine
months net financial expenses were -€201 million versus -€211
million in the same period of 2018.
Third-quarter and first nine months
effective tax rate was stable at 22.0%. Sanofi is
currently actively engaged with the Chinese Ministry of Finance to
support and cooperate with a Pharmaceutical sector audit process
underway.
Third-quarter business net
income(10) increased 4.3% to €2,399 million and increased
0.2% at CER. The ratio of business net income to net sales
increased 0.8 percentage points to 25.3% versus the third quarter
of 2018. First nine months 2019 business net income(10) increased
6.4% to €5,805 million and increased 4.1% at CER. The ratio of
business net income to net sales increased 0.5 percentage points to
21.9% versus the first nine months of 2018.
In the third quarter of 2019, business earnings per
share(10) (EPS) increased 4.3% to €1.92 on a reported
basis and was stable at CER. The average number of shares
outstanding was 1,252.2 million versus 1,247.1 million in the third
quarter of 2018. In the first nine months of 2019, business
earnings per share(10) was €4.65, up 6.4% on a reported basis and
up 4.1% at CER. The average number of shares outstanding was
1,248.9 million in the first nine months of 2019 versus 1,247.6
million in the first nine months of 2018. |
Reconciliation of IFRS net income
reported to business net income (see Appendix 4)
In the first nine months of 2019, the IFRS net
income was €2,816 million. The main items excluded from the
business net income were:
- An amortization charge of €1,636 million related to fair value
remeasurement on intangible assets of acquired companies (primarily
Genzyme: €550 million, Bioverativ: €380 million, Boehringer
Ingelheim CHC business: €184 million, Aventis: €153 million) and to
acquired intangible assets (licenses/products: €80 million). An
amortization charge of €520 million related to fair value
remeasurement on intangible assets of acquired companies (primarily
Genzyme: €182 million, Bioverativ: €108 million, Boehringer
Ingelheim CHC business: €62 million, Aventis: €46 million) and to
acquired intangible assets (licenses/products: €24 million) was
recorded in the third quarter. These items have no cash impact on
the Company.
- An impairment of intangible assets of €2,023 million (of which
€1,835 million in the second quarter mainly related to Eloctate®
and €183 million in the third quarter which included an impairment
related to Zantac®).
- Restructuring costs and similar items of €904 million (of which
€157 million in the third quarter) mainly related to streamlining
initiatives in Japan, Europe and the U.S.
- An income of €242 million mainly reflecting a contingent price
adjustment on the disposal of SP MSD.
- A net income of €260 million (of which a charge of €57 million
in the third quarter) mainly related to litigation.
- A €1,279 million tax effect arising from the items listed
above, mainly comprising €906 million of deferred taxes generated
by amortization and impairments of intangible assets and €247
million associated with restructuring costs and similar items. The
third quarter tax effect was €374 million, including €195 million
of deferred taxes generated by amortization and impairments of
intangible assets and €50 million associated with restructuring
costs and similar items (see Appendix 4).
- An expense of €94 million net of tax (of which €41 million in
the third quarter) related to restructuring costs of associates and
joint ventures and expenses arising from the impact of acquisitions
on associates and joint ventures.
(10) See Appendix 3 for 2019 Third-quarter
consolidated income statement; see Appendix 8 for definitions of
financial indicators, and Appendix 4 for reconciliation of IFRS net
income reported to business net income.
Capital Allocation
In the first nine months of 2019, net cash
generated by operating activities increased 58.2% to €4,976 million
after capital expenditures of €992 million and an increase in
working capital of €1,365 million (which compared with an increase
of €1,925 million over the first nine months of 2018). Over the
period, the dividend paid by Sanofi was €3,834 million,
restructuring costs and similar items cash-out was €917 million and
acquisitions and partnerships net of disposals reflecting a net
cash-in during the period were €525 million. As a consequence, net
debt decreased from €17,628 million at December 31, 2018, to
€16,910 million at September 30, 2019 (amount net of €8,606 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 absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi’s ability to benefit from external growth opportunities, to
complete related transactions and/or obtain regulatory clearances,
risks associated with intellectual property and any related pending
or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic conditions, the impact of cost containment
initiatives and subsequent changes thereto, the average number of
shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2018. 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: |
2019 third-quarter
and first nine months net sales by GBU, franchise, geographic
region and product |
Appendix 2: |
2019 third-quarter
and first nine months business net income statement |
Appendix 3: |
2019 third-quarter
and first nine months consolidated income statement |
Appendix 4: |
Reconciliation of
IFRS net income reported to business net income |
Appendix 5 Appendix 6: Appendix 7: |
Currency
sensitivity R&D pipeline Expected R&D
milestones |
Appendix
8: |
Definitions
of non-GAAP financial indicators |
Appendix 1: 2019 third-quarter net sales by GBU,
franchise, geographic region and product
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q3 2019 (€ million) |
Total GBUs |
% CER |
% reported |
|
Europe |
% CER |
|
United States |
% CER |
|
Rest of the World |
% CER |
|
Emerging Markets |
% CER |
|
Total Franchises |
% CER |
% reported |
|
Aubagio |
482 |
12.8% |
16.7% |
|
103 |
10.8% |
|
363 |
13.8% |
|
16 |
6.7% |
|
12 |
0.0% |
|
494 |
12.4% |
16.0% |
|
Lemtrada |
52 |
-45.2% |
-44.1% |
|
15 |
-60.5% |
|
34 |
-33.3% |
|
3 |
-50.0% |
|
5 |
0.0% |
|
57 |
-42.4% |
-42.4% |
|
Total MS |
534 |
2.2% |
5.5% |
|
118 |
-9.9% |
|
397 |
7.0% |
|
19 |
-5.3% |
|
17 |
0.0% |
|
551 |
2.1% |
5.0% |
|
Cerezyme |
114 |
-4.2% |
-3.4% |
|
60 |
-4.7% |
|
46 |
2.3% |
|
8 |
-30.0% |
|
54 |
34.0% |
|
168 |
6.7% |
1.8% |
|
Cerdelga |
51 |
25.0% |
27.5% |
|
19 |
53.8% |
|
30 |
12.0% |
|
2 |
0.0% |
|
2 |
100.0% |
|
53 |
26.8% |
29.3% |
|
Myozyme |
192 |
5.6% |
8.5% |
|
94 |
4.4% |
|
81 |
8.3% |
|
17 |
0.0% |
|
34 |
18.8% |
|
226 |
7.7% |
8.1% |
|
Fabrazyme |
180 |
0.6% |
4.0% |
|
46 |
7.0% |
|
105 |
0.0% |
|
29 |
-6.7% |
|
22 |
33.3% |
|
202 |
3.7% |
5.8% |
|
Aldurazyme |
36 |
2.9% |
5.9% |
|
19 |
5.6% |
|
12 |
9.1% |
|
5 |
-20.0% |
|
13 |
-6.7% |
|
49 |
0.0% |
0.0% |
|
Total Rare Disease |
637 |
2.8% |
5.8% |
|
253 |
4.1% |
|
298 |
4.8% |
|
86 |
-6.9% |
|
137 |
24.2% |
|
774 |
6.5% |
6.6% |
|
Jevtana |
112 |
9.1% |
13.1% |
|
41 |
5.1% |
|
50 |
8.9% |
|
21 |
20.0% |
|
7 |
0.0% |
|
119 |
8.5% |
12.3% |
|
Mozobil |
45 |
10.0% |
12.5% |
|
12 |
9.1% |
|
28 |
8.0% |
|
5 |
25.0% |
|
5 |
100.0% |
|
50 |
14.3% |
19.0% |
|
Thymoglobulin |
64 |
10.7% |
14.3% |
|
9 |
0.0% |
|
49 |
14.6% |
|
6 |
0.0% |
|
26 |
42.1% |
|
90 |
18.7% |
20.0% |
|
Taxotere |
7 |
-11.1% |
-22.2% |
|
1 |
- |
|
0 |
-100.0% |
|
6 |
-12.5% |
|
35 |
-2.9% |
|
42 |
-4.5% |
-4.5% |
|
Eloxatine |
7 |
-12.5% |
-12.5% |
|
0 |
-100.0% |
|
0 |
- |
|
7 |
0.0% |
|
45 |
9.8% |
|
52 |
6.1% |
6.1% |
|
Total Oncology |
297 |
7.4% |
10.4% |
|
91 |
5.8% |
|
152 |
9.7% |
|
54 |
4.1% |
|
127 |
13.5% |
|
424 |
9.2% |
11.6% |
|
Dupixent |
561 |
140.8% |
151.6% |
|
54 |
170.0% |
|
455 |
130.2% |
|
52 |
242.9% |
|
9 |
300.0% |
|
570 |
142.2% |
153.3% |
|
Kevzara |
49 |
118.2% |
122.7% |
|
12 |
300.0% |
|
33 |
77.8% |
|
4 |
300.0% |
|
0 |
- |
|
49 |
118.2% |
122.7% |
|
Total immunology |
610 |
138.8% |
149.0% |
|
66 |
187.0% |
|
488 |
125.6% |
|
56 |
246.7% |
|
9 |
300.0% |
|
619 |
140.1% |
150.6% |
|
Alprolix |
104 |
12.5% |
18.2% |
|
0 |
- |
|
79 |
17.5% |
|
25 |
0.0% |
|
0 |
- |
|
104 |
12.5% |
18.2% |
|
Eloctate |
157 |
-22.8% |
-18.7% |
|
0 |
- |
|
122 |
-23.5% |
|
35 |
-20.0% |
|
5 |
- |
|
162 |
-20.2% |
-16.1% |
|
Cablivi |
20 |
- |
- |
|
6 |
500.0% |
|
13 |
- |
|
1 |
- |
|
0 |
- |
|
20 |
- |
- |
|
Total Rare Blood Disorder |
281 |
-5.7% |
-0.4% |
|
6 |
500.0% |
|
214 |
-5.6% |
|
61 |
-13.8% |
|
5 |
- |
|
286 |
-3.9% |
1.4% |
|
Sanofi Genzyme (Specialty Care) |
2,359 |
19.5% |
23.9% |
|
534 |
10.3% |
|
1,549 |
25.3% |
|
276 |
9.8% |
|
295 |
21.9% |
|
2,654 |
19.8% |
22.9% |
|
Lantus |
487 |
-27.5% |
-25.5% |
|
140 |
-13.0% |
|
295 |
-32.5% |
|
52 |
-31.1% |
|
264 |
9.5% |
|
751 |
-17.5% |
-16.3% |
|
Toujeo |
175 |
-5.0% |
-3.3% |
|
84 |
18.3% |
|
73 |
-25.0% |
|
18 |
5.6% |
|
43 |
26.5% |
|
218 |
0.0% |
1.4% |
|
Apidra |
51 |
-13.6% |
-13.6% |
|
31 |
-3.1% |
|
11 |
-35.3% |
|
9 |
-10.0% |
|
32 |
23.1% |
|
83 |
-2.4% |
-2.4% |
|
Amaryl |
10 |
-25.0% |
-16.7% |
|
3 |
-40.0% |
|
0 |
- |
|
7 |
-14.3% |
|
74 |
-5.3% |
|
84 |
-8.0% |
-4.5% |
|
Admelog |
51 |
84.6% |
96.2% |
|
4 |
33.3% |
|
47 |
80.0% |
|
0 |
-50.0% |
|
0 |
- |
|
51 |
84.6% |
96.2% |
|
Total Diabetes |
837 |
-17.7% |
-15.5% |
|
295 |
-3.0% |
|
451 |
-24.7% |
|
91 |
-21.7% |
|
424 |
10.1% |
|
1,261 |
-9.9% |
-8.3% |
|
Praluent |
56 |
-15.4% |
-13.8% |
|
22 |
4.5% |
|
29 |
-31.7% |
|
5 |
100.0% |
|
5 |
66.7% |
|
61 |
-11.8% |
-10.3% |
|
Multaq |
85 |
-9.9% |
-6.6% |
|
10 |
-16.7% |
|
74 |
-10.1% |
|
1 |
- |
|
2 |
0.0% |
|
87 |
-9.7% |
-6.5% |
|
Total Cardiovascular |
141 |
-12.2% |
-9.6% |
|
32 |
-2.9% |
|
103 |
-17.5% |
|
6 |
150.0% |
|
7 |
40.0% |
|
148 |
-10.6% |
-8.1% |
|
Plavix |
86 |
-4.5% |
-3.4% |
|
36 |
5.9% |
|
0 |
- |
|
50 |
-10.9% |
|
270 |
0.8% |
|
356 |
-0.6% |
1.4% |
|
Lovenox |
191 |
-16.2% |
-16.2% |
|
164 |
-17.5% |
|
8 |
-22.2% |
|
19 |
0.0% |
|
143 |
14.6% |
|
334 |
-5.4% |
-4.8% |
|
Renagel / Renvela |
59 |
-42.3% |
-39.2% |
|
13 |
-7.1% |
|
39 |
-50.7% |
|
7 |
-25.0% |
|
25 |
47.1% |
|
84 |
-28.9% |
-26.3% |
|
Aprovel |
52 |
10.6% |
10.6% |
|
28 |
7.7% |
|
6 |
200.0% |
|
18 |
-5.3% |
|
117 |
3.6% |
|
169 |
5.7% |
7.0% |
|
Synvisc / Synvisc one |
59 |
-5.1% |
0.0% |
|
5 |
0.0% |
|
50 |
-7.8% |
|
4 |
33.3% |
|
14 |
7.7% |
|
73 |
-2.8% |
1.4% |
|
Allegra |
18 |
-5.6% |
0.0% |
|
2 |
0.0% |
|
0 |
- |
|
16 |
-6.3% |
|
0 |
- |
|
18 |
-5.6% |
0.0% |
|
Stilnox |
41 |
-4.8% |
-2.4% |
|
10 |
25.0% |
|
12 |
0.0% |
|
19 |
-17.4% |
|
15 |
7.1% |
|
56 |
-1.8% |
0.0% |
|
Depakine |
44 |
4.8% |
4.8% |
|
41 |
2.5% |
|
0 |
- |
|
3 |
50.0% |
|
73 |
0.0% |
|
117 |
1.8% |
3.5% |
|
Tritace |
35 |
-2.8% |
-2.8% |
|
35 |
0.0% |
|
0 |
- |
|
0 |
-50.0% |
|
18 |
12.5% |
|
53 |
1.9% |
1.9% |
|
Generics |
92 |
-60.4% |
-58.6% |
|
29 |
-82.8% |
|
36 |
12.9% |
|
27 |
9.1% |
|
176 |
6.8% |
|
268 |
-32.1% |
-30.0% |
|
Other other Rx |
530 |
-7.5% |
-5.7% |
|
392 |
-9.0% |
|
43 |
10.3% |
|
95 |
-7.6% |
|
313 |
9.5% |
|
843 |
-1.8% |
-0.4% |
|
Total Established Rx Products |
1,207 |
-17.9% |
-16.3% |
|
755 |
-21.6% |
|
194 |
-14.7% |
|
258 |
-6.9% |
|
1,164 |
6.9% |
|
2,371 |
-7.3% |
-5.7% |
|
Primary Care |
2,185 |
-17.5% |
-15.6% |
|
1,082 |
-16.8% |
|
748 |
-21.3% |
|
355 |
-10.6% |
|
1,595 |
7.9% |
|
3,780 |
-8.3% |
-6.7% |
|
China and Emerging Markets |
1,890 |
10.0% |
10.0% |
|
|
|
|
|
|
|
|
|
|
1,890 |
10.0% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Pharmaceuticals |
6,434 |
1.5% |
3.6% |
|
1,616 |
-9.4% |
|
2,297 |
5.0% |
|
631 |
-2.8% |
|
1,890 |
10.0% |
|
6,434 |
1.5% |
3.6% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy, Cough and Cold |
287 |
1.4% |
4.0% |
|
84 |
-4.5% |
|
72 |
0.0% |
|
33 |
14.3% |
|
98 |
4.4% |
|
287 |
1.4% |
4.0% |
|
Pain |
300 |
3.8% |
3.4% |
|
112 |
-6.7% |
|
45 |
2.4% |
|
36 |
20.7% |
|
107 |
12.1% |
|
300 |
3.8% |
3.4% |
|
Digestive |
229 |
-4.7% |
-2.1% |
|
68 |
-2.9% |
|
33 |
-34.0% |
|
14 |
-7.1% |
|
114 |
7.8% |
|
229 |
-4.7% |
-2.1% |
|
Nutritional |
178 |
1.8% |
4.1% |
|
28 |
-6.7% |
|
10 |
0.0% |
|
71 |
0.0% |
|
69 |
8.2% |
|
178 |
1.8% |
4.1% |
|
Consumer Healthcare |
1,136 |
0.4% |
2.1% |
|
306 |
-7.0% |
|
252 |
-4.4% |
|
164 |
6.6% |
|
414 |
7.3% |
|
1,136 |
0.4% |
2.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
515 |
-1.2% |
0.8% |
|
73 |
0.0% |
|
78 |
-37.8% |
|
34 |
-25.6% |
|
330 |
18.2% |
|
515 |
-1.2% |
0.8% |
|
Adult Booster Vaccines |
182 |
17.4% |
22.1% |
|
42 |
40.0% |
|
122 |
17.0% |
|
8 |
20.0% |
|
10 |
-28.6% |
|
182 |
17.4% |
22.1% |
|
Meningitis/Pneumonia |
310 |
8.8% |
13.6% |
|
0 |
- |
|
275 |
14.8% |
|
5 |
0.0% |
|
30 |
-25.0% |
|
310 |
8.8% |
13.6% |
|
Influenza Vaccines |
735 |
-28.5% |
-25.4% |
|
86 |
3.6% |
|
580 |
-32.6% |
|
27 |
-16.1% |
|
42 |
-22.6% |
|
735 |
-28.5% |
-25.4% |
|
Travel And Other Endemic Vaccines |
159 |
20.8% |
22.3% |
|
33 |
6.5% |
|
41 |
-2.6% |
|
16 |
38.5% |
|
69 |
44.7% |
|
159 |
20.8% |
22.3% |
|
Vaccines |
1,929 |
-9.8% |
-6.8% |
|
235 |
7.8% |
|
1,122 |
-19.5% |
|
91 |
-8.2% |
|
481 |
10.7% |
|
1,929 |
-9.8% |
-6.8% |
|
Total Company |
9,499 |
-1.1% |
1.1% |
|
2,157 |
-7.5% |
|
3,671 |
-4.5% |
|
886 |
-1.7% |
|
2,785 |
9.7% |
|
9,499 |
-1.1% |
1.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 first nine months net sales by GBU,
franchise, geographic region and product
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First 9M 2019 (€ million) |
Total GBUs |
% CER |
% reported |
|
Europe |
% CER |
|
United States |
% CER |
|
Rest of the World |
% CER |
|
Emerging Markets |
% CER |
|
Total Franchises |
% CER |
% reported |
|
Aubagio |
1,359 |
11.8% |
16.9% |
|
306 |
10.5% |
|
1,008 |
12.2% |
|
45 |
12.5% |
|
38 |
7.9% |
|
1,397 |
11.7% |
16.3% |
|
Lemtrada |
204 |
-31.6% |
-29.2% |
|
78 |
-40.0% |
|
117 |
-22.9% |
|
9 |
-42.9% |
|
19 |
22.2% |
|
223 |
-28.4% |
-27.1% |
|
Total MS |
1,563 |
3.2% |
7.7% |
|
384 |
-5.7% |
|
1,125 |
7.1% |
|
54 |
-1.9% |
|
57 |
12.5% |
|
1,620 |
3.5% |
7.5% |
|
Cerezyme |
342 |
-5.6% |
-3.4% |
|
183 |
-7.1% |
|
134 |
0.0% |
|
25 |
-20.7% |
|
189 |
31.1% |
|
531 |
6.1% |
1.9% |
|
Cerdelga |
147 |
25.7% |
30.1% |
|
53 |
54.3% |
|
87 |
12.5% |
|
7 |
16.7% |
|
4 |
150.0% |
|
151 |
27.8% |
31.3% |
|
Myozyme |
575 |
6.3% |
9.3% |
|
286 |
2.9% |
|
243 |
11.7% |
|
46 |
2.3% |
|
105 |
30.7% |
|
680 |
9.8% |
10.7% |
|
Fabrazyme |
529 |
3.0% |
7.3% |
|
136 |
4.6% |
|
304 |
2.5% |
|
89 |
2.4% |
|
69 |
35.7% |
|
598 |
6.4% |
8.9% |
|
Aldurazyme |
114 |
5.7% |
8.6% |
|
58 |
3.6% |
|
38 |
12.5% |
|
18 |
0.0% |
|
56 |
27.7% |
|
170 |
12.5% |
11.8% |
|
Total Rare Disease |
1,890 |
3.2% |
6.7% |
|
764 |
2.5% |
|
874 |
5.4% |
|
252 |
-1.6% |
|
460 |
31.1% |
|
2,350 |
8.3% |
8.6% |
|
Jevtana |
335 |
11.4% |
15.5% |
|
127 |
8.5% |
|
151 |
10.9% |
|
57 |
20.5% |
|
21 |
16.7% |
|
356 |
11.7% |
15.6% |
|
Mozobil |
132 |
8.5% |
12.8% |
|
36 |
2.9% |
|
82 |
10.0% |
|
14 |
16.7% |
|
11 |
57.1% |
|
143 |
11.3% |
15.3% |
|
Thymoglobulin |
189 |
10.4% |
16.0% |
|
27 |
-3.6% |
|
144 |
14.3% |
|
18 |
6.3% |
|
76 |
39.3% |
|
265 |
17.8% |
21.0% |
|
Taxotere |
22 |
-15.4% |
-15.4% |
|
3 |
50.0% |
|
-1 |
-150.0% |
|
20 |
-9.1% |
|
109 |
4.9% |
|
131 |
0.8% |
2.3% |
|
Eloxatine |
17 |
-29.2% |
-29.2% |
|
1 |
-50.0% |
|
-4 |
- |
|
20 |
-9.1% |
|
144 |
24.3% |
|
161 |
15.1% |
15.8% |
|
Total Oncology |
872 |
6.7% |
10.5% |
|
272 |
3.8% |
|
439 |
8.6% |
|
161 |
6.9% |
|
382 |
19.5% |
|
1,254 |
10.4% |
13.3% |
|
Dupixent |
1,377 |
158.8% |
172.7% |
|
136 |
195.7% |
|
1,124 |
143.9% |
|
117 |
358.3% |
|
18 |
466.7% |
|
1,395 |
160.6% |
174.6% |
|
Kevzara |
130 |
140.4% |
150.0% |
|
30 |
275.0% |
|
81 |
87.8% |
|
19 |
500.0% |
|
1 |
- |
|
131 |
142.3% |
151.9% |
|
Total immunology |
1,507 |
157.1% |
170.6% |
|
166 |
207.4% |
|
1,205 |
139.1% |
|
136 |
374.1% |
|
19 |
500.0% |
|
1,526 |
158.9% |
172.5% |
|
Alprolix |
304 |
51.1% |
60.0% |
|
0 |
- |
|
223 |
43.2% |
|
81 |
77.3% |
|
0 |
- |
|
304 |
51.1% |
60.0% |
|
Eloctate |
494 |
12.6% |
19.9% |
|
0 |
- |
|
394 |
9.1% |
|
100 |
29.2% |
|
13 |
- |
|
507 |
15.8% |
23.1% |
|
Cablivi |
40 |
- |
- |
|
15 |
- |
|
24 |
- |
|
1 |
- |
|
0 |
- |
|
40 |
- |
- |
|
Total Rare Blood Disorder |
838 |
30.8% |
39.0% |
|
15 |
- |
|
641 |
24.1% |
|
182 |
47.4% |
|
13 |
- |
|
851 |
33.0% |
41.1% |
|
Sanofi Genzyme (Specialty Care) |
6,670 |
23.5% |
29.0% |
|
1,601 |
9.0% |
|
4,284 |
29.7% |
|
785 |
27.4% |
|
931 |
28.5% |
|
7,601 |
24.2% |
27.9% |
|
Lantus |
1,466 |
-28.2% |
-25.4% |
|
438 |
-15.1% |
|
863 |
-34.3% |
|
165 |
-24.4% |
|
817 |
12.9% |
|
2,283 |
-17.0% |
-15.4% |
|
Toujeo |
517 |
-5.1% |
-2.5% |
|
247 |
16.0% |
|
212 |
-24.3% |
|
58 |
5.6% |
|
132 |
36.4% |
|
649 |
1.4% |
3.2% |
|
Apidra |
160 |
-16.0% |
-14.9% |
|
97 |
-4.9% |
|
36 |
-40.4% |
|
27 |
-6.9% |
|
96 |
23.8% |
|
256 |
-4.1% |
-4.5% |
|
Amaryl |
32 |
-13.9% |
-11.1% |
|
11 |
-15.4% |
|
1 |
0.0% |
|
20 |
-13.6% |
|
223 |
-0.9% |
|
255 |
-2.7% |
-1.2% |
|
Admelog |
194 |
405.6% |
438.9% |
|
11 |
120.0% |
|
183 |
437.5% |
|
0 |
0.0% |
|
0 |
- |
|
194 |
405.6% |
438.9% |
|
Total Diabetes |
2,551 |
-15.6% |
-12.6% |
|
903 |
-5.1% |
|
1,357 |
-21.8% |
|
291 |
-15.4% |
|
1,294 |
11.2% |
|
3,845 |
-7.9% |
-6.2% |
|
Praluent |
169 |
-4.7% |
-1.7% |
|
83 |
31.7% |
|
73 |
-32.4% |
|
13 |
71.4% |
|
14 |
100.0% |
|
183 |
-0.6% |
2.2% |
|
Multaq |
242 |
-8.0% |
-3.2% |
|
30 |
-9.1% |
|
209 |
-7.9% |
|
3 |
0.0% |
|
6 |
20.0% |
|
248 |
-7.5% |
-2.7% |
|
Total Cardiovascular |
411 |
-6.6% |
-2.6% |
|
113 |
17.7% |
|
282 |
-15.8% |
|
16 |
50.0% |
|
20 |
66.7% |
|
431 |
-4.6% |
-0.7% |
|
Plavix |
255 |
-9.5% |
-7.3% |
|
105 |
-4.5% |
|
0 |
- |
|
150 |
-12.7% |
|
867 |
2.5% |
|
1,122 |
-0.4% |
0.9% |
|
Lovenox |
620 |
-18.6% |
-18.4% |
|
539 |
-19.5% |
|
26 |
-17.2% |
|
55 |
-8.3% |
|
404 |
12.8% |
|
1,024 |
-8.5% |
-8.5% |
|
Renagel / Renvela |
160 |
-42.3% |
-39.6% |
|
39 |
-15.2% |
|
98 |
-53.1% |
|
23 |
-4.3% |
|
69 |
36.0% |
|
229 |
-29.8% |
-27.3% |
|
Aprovel |
159 |
6.8% |
7.4% |
|
82 |
1.2% |
|
20 |
171.4% |
|
57 |
-5.0% |
|
384 |
7.4% |
|
543 |
7.2% |
8.4% |
|
Synvisc / Synvisc one |
183 |
-8.9% |
-3.7% |
|
19 |
5.6% |
|
153 |
-11.1% |
|
11 |
0.0% |
|
45 |
4.8% |
|
228 |
-6.5% |
-1.7% |
|
Allegra |
100 |
-3.1% |
2.0% |
|
8 |
14.3% |
|
0 |
- |
|
92 |
-4.4% |
|
0 |
- |
|
100 |
-3.1% |
2.0% |
|
Stilnox |
117 |
-11.1% |
-7.1% |
|
27 |
-3.6% |
|
30 |
-15.2% |
|
60 |
-12.3% |
|
46 |
0.0% |
|
163 |
-8.1% |
-5.2% |
|
Depakine |
131 |
-1.5% |
-1.5% |
|
121 |
-2.4% |
|
0 |
- |
|
10 |
11.1% |
|
222 |
4.8% |
|
353 |
2.3% |
2.9% |
|
Tritace |
109 |
-1.8% |
-1.8% |
|
106 |
-0.9% |
|
0 |
- |
|
3 |
-25.0% |
|
53 |
-3.6% |
|
162 |
-2.4% |
-3.0% |
|
Generics |
306 |
-58.5% |
-56.8% |
|
90 |
-83.2% |
|
115 |
38.0% |
|
101 |
2.2% |
|
498 |
0.0% |
|
804 |
-33.9% |
-34.1% |
|
Other other Rx |
1,649 |
-6.5% |
-5.3% |
|
1,227 |
-6.8% |
|
136 |
-8.6% |
|
286 |
-3.9% |
|
906 |
0.5% |
|
2,555 |
-4.1% |
-3.9% |
|
Total Established Rx Products |
3,789 |
-18.3% |
-16.8% |
|
2,363 |
-22.3% |
|
578 |
-15.8% |
|
848 |
-5.9% |
|
3,494 |
3.7% |
|
7,283 |
-8.9% |
-8.2% |
|
Primary Care |
6,751 |
-16.7% |
-14.5% |
|
3,379 |
-17.4% |
|
2,217 |
-19.6% |
|
1,155 |
-8.1% |
|
4,808 |
5.8% |
|
11,559 |
-8.4% |
-7.3% |
|
China and Emerging Markets |
5,739 |
9.1% |
7.5% |
|
|
|
|
|
|
|
|
|
|
5,739 |
9.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Pharmaceuticals |
19,160 |
2.1% |
4.1% |
|
4,980 |
-10.4% |
|
6,501 |
7.3% |
|
1,940 |
3.5% |
|
5,739 |
9.1% |
|
19,160 |
2.1% |
4.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergy, Cough and Cold |
898 |
2.3% |
4.9% |
|
247 |
-3.1% |
|
259 |
0.4% |
|
121 |
10.4% |
|
271 |
6.3% |
|
898 |
2.3% |
4.9% |
|
Pain |
930 |
2.6% |
1.3% |
|
366 |
-1.9% |
|
138 |
8.3% |
|
99 |
9.3% |
|
327 |
3.8% |
|
930 |
2.6% |
1.3% |
|
Digestive |
777 |
4.7% |
6.4% |
|
235 |
1.3% |
|
136 |
-10.6% |
|
42 |
-2.4% |
|
364 |
15.0% |
|
777 |
4.7% |
6.4% |
|
Nutritional |
492 |
-3.0% |
-1.8% |
|
90 |
-1.1% |
|
29 |
0.0% |
|
193 |
-2.1% |
|
180 |
-5.3% |
|
492 |
-3.0% |
-1.8% |
|
Consumer Healthcare |
3,535 |
0.7% |
2.0% |
|
986 |
-4.5% |
|
840 |
-0.4% |
|
482 |
2.6% |
|
1,227 |
5.2% |
|
3,535 |
0.7% |
2.0% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio / Pertussis / Hib |
1,503 |
19.3% |
20.7% |
|
224 |
5.2% |
|
270 |
-14.2% |
|
144 |
10.5% |
|
865 |
42.1% |
|
1,503 |
19.3% |
20.7% |
|
Adult Booster Vaccines |
416 |
20.0% |
24.2% |
|
127 |
32.3% |
|
246 |
18.3% |
|
21 |
11.1% |
|
22 |
-8.3% |
|
416 |
20.0% |
24.2% |
|
Meningitis/Pneumonia |
558 |
12.3% |
16.7% |
|
0 |
- |
|
450 |
10.6% |
|
12 |
0.0% |
|
96 |
22.2% |
|
558 |
12.3% |
16.7% |
|
Influenza Vaccines |
852 |
-25.9% |
-23.4% |
|
88 |
4.8% |
|
584 |
-32.6% |
|
47 |
-14.5% |
|
133 |
-10.6% |
|
852 |
-25.9% |
-23.4% |
|
Travel And Other Endemic Vaccines |
416 |
14.2% |
16.2% |
|
100 |
11.1% |
|
115 |
6.9% |
|
46 |
17.1% |
|
155 |
21.4% |
|
416 |
14.2% |
16.2% |
|
Vaccines |
3,823 |
3.9% |
6.5% |
|
542 |
10.6% |
|
1,731 |
-11.5% |
|
277 |
5.5% |
|
1,273 |
28.7% |
|
3,823 |
3.9% |
6.5% |
|
Total Company |
26,518 |
2.2% |
4.1% |
|
6,508 |
-8.1% |
|
9,072 |
2.4% |
|
2,699 |
3.5% |
|
8,239 |
11.1% |
|
26,518 |
2.2% |
4.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Appendix 2: Business net income
statement
Third Quarter 2019 |
Pharmaceuticals |
Consumer Healthcare |
Vaccines |
Others(1) |
Total Group |
€ million |
Q3 2019 |
Q3 2018 |
Change |
Q3 2019 |
Q3 2018 |
Change |
Q3 2019 |
Q3 2018 |
Change |
Q3 2019 |
Q3 2018 |
Change |
Q3 2019 |
Q3 2018 |
Change |
|
Net sales |
6,434 |
6,210 |
3.6% |
1,136 |
1,113 |
2.1% |
1,929 |
2,069 |
(6.8)% |
— |
— |
|
9,499 |
9,392 |
1.1% |
|
Other revenues |
49 |
51 |
(3.9)% |
— |
— |
|
373 |
301 |
23.9% |
— |
— |
|
422 |
352 |
19.9% |
|
Cost of Sales |
(1,673) |
(1,688) |
(0.9)% |
(400) |
(370) |
8.1% |
(1,002) |
(920) |
8.9% |
(59) |
(39) |
51.3% |
(3,134) |
(3,017) |
3.9% |
|
As % of net sales |
(26.0)% |
(27.2)% |
|
(35.2)% |
(33.2)% |
|
(51.9)% |
(44.5)% |
|
|
|
|
(33.0)% |
(32.1)% |
|
|
Gross Profit |
4,810 |
4,573 |
5.2% |
736 |
743 |
(0.9)% |
1,300 |
1,450 |
(10.3)% |
(59) |
(39) |
|
6,787 |
6,727 |
0.9% |
|
As % of net sales |
74.8% |
73.6% |
|
64.8% |
66.8% |
|
67.4% |
70.1% |
|
|
|
|
71.4% |
71.6% |
|
|
Research and development
expenses |
(1,024) |
(1,148) |
(10.8)% |
(33) |
(37) |
(10.8)% |
(156) |
(125) |
24.8% |
(149) |
(151) |
(1.3)% |
(1,362) |
(1,461) |
(6.8)% |
|
As % of net sales |
(15.9)% |
(18.5)% |
|
(2.9)% |
(3.3)% |
|
(8.1)% |
(6.0)% |
|
|
|
|
(14.3)% |
(15.6)% |
|
|
Selling general and
administrativeexpenses |
(1,237) |
(1,298) |
(4.7)% |
(368) |
(337) |
9.2% |
(190) |
(174) |
9.2% |
(519) |
(492) |
5.5% |
(2,314) |
(2,301) |
0.6% |
|
As % of net sales |
(19.2)% |
(20.9)% |
|
(32.4)% |
(30.3)% |
|
(9.8)% |
(8.4)% |
|
|
|
|
(24.4)% |
(24.5)% |
|
|
Other current operating
income/expenses |
(154) |
(46) |
|
33 |
3 |
|
1 |
(3) |
|
1 |
(28) |
|
(119) |
(74) |
|
|
Share of profit/loss of
associates* and joint ventures |
123 |
155 |
|
— |
1 |
|
9 |
(3) |
|
— |
— |
|
132 |
153 |
|
|
Net income attributable to
non-controlling interests |
(7) |
(23) |
|
(5) |
(3) |
|
— |
— |
|
— |
— |
|
(12) |
(26) |
|
|
Business operating
income |
2,511 |
2,213 |
13.5% |
363 |
370 |
(1.9)% |
964 |
1,145 |
(15.8)% |
(726) |
(710) |
2.3% |
3,112 |
3,018 |
3.1% |
|
As % of net sales |
39.0% |
35.6% |
|
32.0% |
33.2% |
|
50.0% |
55.3% |
|
|
|
|
32.8% |
32.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income and
expenses |
(71) |
(106) |
|
|
|
|
|
|
|
|
Income tax expenses |
|
(642) |
(613) |
|
|
|
|
|
|
|
|
Tax rate** |
|
22.0% |
22.0% |
|
|
|
|
|
|
|
|
Business net
income |
|
2,399 |
2,299 |
4.3% |
|
|
|
|
|
|
|
As % of net
sales |
|
25.3% |
24.5% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business earnings /
share (in euros)*** |
1.92 |
1.84 |
4.3% |
* 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
1,252.2 million in the third quarter of 2019 and 1,247.1 million in
the third quarter of 2018. (1) Others include the cost of
Global Support Functions (Medical Affairs, External Affairs,
Finance, Human Resources, Information Solution & Technologies,
Sanofi Business Services, etc…).
Nine Months 2019 |
Pharmaceuticals |
Consumer Healthcare |
Vaccines |
Others (1) |
Total Group |
€ million |
9M 2019 |
9M 2018 |
Change |
9M 2019 |
9M 2018 |
Change |
9M 2019 |
9M 2018 |
Change |
9M 2019 |
9M 2018 |
Change |
9M 2019 |
9M 2018 |
Change |
|
Net sales |
19,160 |
18,409 |
4.1% |
3,535 |
3,466 |
2.0% |
3,823 |
3,591 |
6.5% |
— |
— |
|
26,518 |
25,466 |
4.1% |
|
Other revenues |
178 |
185 |
(3.8)% |
1 |
— |
|
917 |
700 |
31.0% |
— |
— |
|
1,096 |
885 |
23.8% |
|
Cost of Sales |
(4,915) |
(4,918) |
(0.1)% |
(1,173) |
(1,133) |
3.5% |
(2,261) |
(1,988) |
13.7% |
(170) |
(144) |
18.1% |
(8,519) |
(8,183) |
4.1% |
|
As % of net sales |
(25.7)% |
(26.7)% |
|
(33.2)% |
(32.7)% |
|
(59.1)% |
(55.4)% |
|
|
|
|
(32.1)% |
(32.1)% |
|
|
Gross Profit |
14,423 |
13,676 |
5.5% |
2,363 |
2,333 |
1.3% |
2,479 |
2,303 |
7.6% |
(170) |
(144) |
|
19,095 |
18,168 |
5.1% |
|
As % of net sales |
75.3% |
74.3% |
|
66.8% |
67.3% |
|
64.8% |
64.1% |
|
|
|
|
72.0% |
71.3% |
|
|
Research and development
expenses |
(3,330) |
(3,261) |
2.1% |
(103) |
(95) |
8.4% |
(458) |
(393) |
16.5% |
(444) |
(467) |
(4.9)% |
(4,335) |
(4,216) |
2.8% |
|
As % of net sales |
(17.4)% |
(17.7)% |
|
(2.9)% |
(2.7)% |
|
(12.0)% |
(10.9)% |
|
|
|
|
(16.3)% |
(16.6)% |
|
|
Selling, general and
administrative expenses |
(3,891) |
(3,946) |
(1.4)% |
(1,145) |
(1,125) |
1.8% |
(548) |
(500) |
9.6% |
(1,572) |
(1,539) |
2.1% |
(7,156) |
(7,110) |
0.6% |
|
As % of net sales |
(20.3)% |
(21.4)% |
|
(32.4)% |
(32.5)% |
|
(14.3)% |
(13.9)% |
|
|
|
|
(27.0)% |
(27.9)% |
|
|
Other current operating
income/expenses |
(388) |
86 |
|
138 |
85 |
|
(5) |
(3) |
|
(57) |
(84) |
|
(312) |
84 |
|
|
Share of profit/loss of
associates* and joint ventures |
292 |
305 |
|
— |
1 |
|
9 |
(4) |
|
— |
— |
|
301 |
302 |
|
|
Net income attributable to
non-controlling interests |
(16) |
(75) |
|
(11) |
(9) |
|
— |
— |
|
— |
— |
|
(27) |
(84) |
|
|
Business operating
income |
7,090 |
6,785 |
4.5% |
1,242 |
1,190 |
4.4% |
1,477 |
1,403 |
5.3% |
(2,243) |
(2,234) |
0.4% |
7,566 |
7,144 |
5.9% |
|
As % of net sales |
37.0% |
36.9% |
|
35.1% |
34.3% |
|
38.6% |
39.1% |
|
|
|
|
28.5% |
28.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income and
expenses |
(201) |
(211) |
|
|
|
|
|
|
|
|
Income tax expenses |
|
|
|
(1,560) |
(1,478) |
|
|
|
|
|
|
|
|
Tax rate** |
|
22.0% |
22.0% |
|
|
|
|
|
|
|
|
Business net
income |
|
5,805 |
5,455 |
6.4% |
|
|
|
|
|
|
|
As % of net
sales |
|
21.9% |
21.4% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business earnings /
share (in euros)*** |
4.65 |
4.37 |
6.4% |
* 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 1,248.9 million
in the nine first months of 2019 and 1,247.6 million in the nine
first months of 2018. (1) Other includes the cost of global
support functions (Medical Affairs, External Affairs, Finance,
Human Resources, Information Solution & Technologies, Sanofi
Business Services, etc…).
Appendix 3: Consolidated income statements
€ million |
Q3 2019 |
Q3 2018 |
9M 2019 |
9M 2018 |
|
Net sales |
9,499 |
9,392 |
26,518 |
25,466 |
Other revenues |
422 |
352 |
1,096 |
885 |
Cost of sales |
(3,134) |
(3,032) |
(8,519) |
(8,297) |
Gross profit |
6,787 |
6,712 |
19,095 |
18,054 |
Research and development expenses |
(1,360) |
(1,461) |
(4,332) |
(4,216) |
Selling and general expenses |
(2,311) |
(2,310) |
(7,146) |
(7,129) |
Other operating income |
123 |
78 |
396 |
401 |
Other operating expenses |
(242) |
(152) |
(708) |
(317) |
Amortization of intangible assets |
(520) |
(537) |
(1,636) |
(1,536) |
Impairment of intangible assets |
(183) |
(191) |
(2,023) |
(292) |
Fair value remeasurement of contingent consideration |
52 |
107 |
242 |
117 |
Restructuring costs and similar items |
(157) |
(108) |
(904) |
(715) |
Other gains and losses, and litigation(1) |
(57) |
576 |
260 |
509 |
Operating income |
2,132 |
2,714 |
3,244 |
4,876 |
Financial expenses |
(109) |
(130) |
(353) |
(332) |
Financial income |
29 |
24 |
123 |
121 |
Income
before tax and associates and joint ventures |
2,052 |
2,608 |
3,014 |
4,665 |
Income tax expense |
(268) |
(427) |
(281) |
(724) |
Share of profit/(loss) of associates and joint ventures |
91 |
123 |
207 |
198 |
Net income excluding the
exchanged/held-for-exchange Animal Health business |
1,875 |
2,304 |
2,940 |
4,139 |
Net income/(loss) of the exchanged/held-for-exchange Animal Health
business |
(100) |
(4) |
(100) |
(4) |
Net income |
1,775 |
2,300 |
2,840 |
4,135 |
Net income attributable to non-controlling interests |
9 |
26 |
24 |
83 |
Net income attributable to
equity holders of Sanofi |
1,766 |
2,274 |
2,816 |
4,052 |
Average number of shares outstanding
(million) |
1,252.2 |
1,247.1 |
1,248.9 |
1,247.6 |
Earnings per share excluding
the exchanged/held-for-exchange Animal Health business (in
euros) |
1.49 |
1.83 |
2.33 |
3.25 |
IFRS Earnings per share (in
euros) |
1.41 |
1.82 |
2.25 |
3.25 |
(1) In 2019, mainly related to litigation. In 2018, pre-tax
capital gain arising on the divestment of European generics
business (completed September 30, 2018).
Appendix 4: Reconciliation of Net income attributable to
equity holders of Sanofi to Business net income
€ million |
Q3 2019 |
|
Q3 2018 |
|
Change |
Net income attributable to equity
holders of Sanofi |
1,766 |
|
2,274 |
|
(22.3)% |
Amortization of intangible assets(1) |
520 |
|
537 |
|
|
Impairment of intangible assets |
183 |
|
191 |
|
|
Fair value remeasurement of contingent
consideration |
(52) |
|
(107) |
|
|
Expenses arising from the impact of
acquisitions on inventories |
— |
|
15 |
|
|
Other expenses related to business
combinations |
— |
|
9 |
|
|
Restructuring costs and similar items |
157 |
|
108 |
|
|
Other gains and losses, and
litigation(2) |
57 |
|
(576) |
|
|
Effects of IFRS 16 on Lease
contracts(3) |
4 |
|
— |
|
|
Tax effect of the items listed above: |
(374) |
|
(147) |
|
|
Amortization and impairment of intangible assets |
(195) |
|
(176) |
|
|
Fair value remeasurement of contingent consideration |
(20) |
|
24 |
|
|
Expenses arising from the impact of acquisitions on
inventories |
— |
|
(4) |
|
|
Restructuring costs and similar items |
(50) |
|
(32) |
|
|
Other tax effects |
(109) |
|
41 |
|
|
Other tax items(4) |
— |
|
(39) |
|
|
Share of items listed above attributable
to non-controlling interests |
(3) |
|
— |
|
|
Restructuring costs of associates and
joint ventures, and expenses arising from the impact of
acquisitions on associates and joint ventures |
41 |
|
30 |
|
|
Animal Health items |
100 |
|
4 |
|
|
Business net income |
2,399 |
|
2,299 |
|
4.3% |
IFRS earnings per share(5) (in
euros) |
1.41 |
|
1.82 |
|
|
(1) Of which related to amortization expense generated by
the remeasurement of intangible assets as part of business
combinations: €496 million in the third quarter of 2019
and €505 million in the third quarter of 2018.(2) In 2019, mainly
related to litigation. In 2018, pre-tax capital gain arising on the
divestment of European generics business (completed September 30,
2018). (3) Impact of new lease standard IFRS 16, is effective
January 1, 2019 using the modified retrospective transition method
(no restatement of prior periods), since Business Net Income
remains reported as previously under IAS 17 and related
interpretations for comparison
purposes.
(4) In 2018, adjustments made to our preliminary analysis of
the direct and indirect impact of US tax reform.
(5) Based on an average number of shares outstanding of
1,252.2 million in the third quarter of 2019 and 1,247.1 million in
the third quarter of
2018.
€ million |
9M 2019 |
|
9M 2018 |
|
Change |
Net income attributable to
equity holders of Sanofi |
2,816 |
|
4,052 |
|
(30.5)% |
Amortization of intangible
assets(1) |
1,636 |
|
1,536 |
|
|
Impairment of intangible assets(2) |
2,023 |
|
292 |
|
|
Fair value remeasurement of contingent
consideration |
(242) |
|
(117) |
|
|
Expenses arising from the impact of
acquisitions on inventories |
3 |
|
114 |
|
|
Other expenses related to business
combinations |
— |
|
19 |
|
|
Restructuring costs and similar
items |
904 |
|
715 |
|
|
Other gains and losses, and
litigation(3) |
(260) |
|
(509) |
|
|
Effects of IFRS 16 on Lease
contracts(4) |
13 |
|
— |
|
|
Tax effect of the items listed
above: |
(1,279) |
|
(622) |
|
|
Amortization and impairment of intangible assets |
(906) |
|
(451) |
|
|
Fair value remeasurement of contingent consideration |
4 |
|
35 |
|
|
Expenses arising from the impact of acquisitions on
inventories |
— |
|
(27) |
|
|
Restructuring costs and similar items |
(247) |
|
(215) |
|
|
Other tax effects |
(130) |
|
36 |
|
|
Other tax items(5) |
— |
|
(132) |
|
|
Share of items listed above
attributable to non-controlling interests |
(3) |
|
(1) |
|
|
Restructuring costs of associates and
joint ventures, and expenses arising from the impact of
acquisitions on associates and joint ventures |
94 |
|
104 |
|
|
Animal Health items |
100 |
|
4 |
|
|
Business net
income |
5,805 |
|
5,455 |
|
6.4% |
IFRS earnings per share(6) (in
euros) |
2.25 |
|
3.25 |
|
|
- Of which related to amortization expense generated by the
remeasurement of intangible assets as part of business
combinations: €1,556 million in the nine first months
of 2019 and €1,437 million in the nine first months of 2018.
- In 2019, €1,835 million mainly related to Eloctate
impairment.
- In 2019, mainly related to litigation. In 2018, pre-tax
capital gain arising on the divestment of European Generics
business (completed September 30, 2018).
- Impact of new lease standard IFRS 16, is effective January 1,
2019 using the modified retrospective transition method (no
restatement of prior periods), since Business Net Income remains
reported as previously under IAS 17 and related interpretations for
comparison purposes.
- In 2018, adjustment made to our preliminary analysis of the
direct and indirect impacts of US tax reform.
- Based on an average number of shares outstanding of 1,248.9
million in the nine first months of 2019 and 1,247.6 million in the
nine first months of 2018.
Appendix 5: Currency
sensitivity
2019 business EPS currency sensitivity
Currency |
Variation |
Business EPS Sensitivity |
U.S. Dollar |
+0.05
USD/EUR |
-EUR
0.10 |
Japanese Yen |
+5
JPY/EUR |
-EUR
0.02 |
Chinese Yuan |
+0.2
CNY/EUR |
-EUR
0.02 |
Brazilian Real |
+0.4
BRL/EUR |
-EUR
0.01 |
Russian
Ruble |
+10 RUB/EUR |
-EUR 0.03 |
Currency exposure on Q3 2019 sales
Currency |
Q3 2019 |
US
$ |
39.7% |
Euro
€ |
20.5% |
Chinese Yuan |
7.8% |
Japanese Yen |
4.7% |
Brazilian Real |
2.6% |
Mexican Peso |
1.8% |
Russian Ruble |
1.6% |
British Pound |
1.5% |
Canadian $ |
1.5% |
Australian $ |
1.3% |
Others |
17.0% |
Currency average rates
|
Q3 2018 |
Q3 2019 |
Change |
€/$ |
1.16 |
1.11 |
-4.4% |
€/Yen |
129.66 |
119.33 |
-8.0% |
€/Yuan |
7.92 |
7.81 |
-1.4% |
€/Real |
4.60 |
4.42 |
-4.1% |
€/Ruble |
76.28 |
71.86 |
-5.8% |
Appendix 6: R&D Pipeline
|
Immuno-inflammation |
|
Rare Blood
Disorders |
|
Cardiovascular &
metabolism |
|
Oncology |
|
MS & Neuro |
|
Vaccines |
|
Rare Diseases |
|
Diabetes |
|
|
New Molecular Entities(*)
Phase 1 (Total : 22) |
Phase 2 (Total : 7) |
Phase 3 (Total : 6) |
Registration (Total : 2) |
SAR441344(**)(1)Anti-CD40L
mAbMultiple Sclerosis |
BIVV001(**)(5)
rFVIIIFc – vWF – XTEN(6) Hemophilia A |
SAR440340(**)(12)Anti-IL33 mAbAtopic
Dermatitis |
SAR422459(**)(14) ABCA4 gene therapy Stargardt
Disease |
avalglucosidase alfaNeo GAA Pompe Disease |
isatuximab Anti-CD38 mAb3L RRMM (ICARIA)
(U.S.,EU) |
SAR408701 Maytansin-loaded anti-CEACAM5 mAb,
NSCLC |
ST400(**)(7) Ex
Vivo ZFN Gene-Edited Cell Therapy, Beta thalassemia |
romilkimab (SAR156597) Anti-IL4/IL13 bispecific
mAb Systemic Scleroderma |
SAR442168(**)(15)BTK
inhibitor Multiple Sclerosis |
venglustatOral GCS inhibitorADPKD(16) |
SAR341402 (insulin aspart) Rapid
acting insulin Type 1/2 Diabetes (EU) |
SAR439459 anti-TGFb mAbAdvanced Solid Tumors |
BIVV003(**)(7)
Ex Vivo ZFN Gene-Edited Cell Therapy, Sickle Cell Disease |
R |
olipudase alfa rhASM AS Deficiency(13) |
HIV Viral vector prime & rgp120 boost
vaccine |
fitusiran RNAi targeting anti-thrombin Hemophilia
A and B |
|
|
O |
REGN5458(**)(2)Anti-BCMAxCD3 bispecific
mAbRelapsing Refractory MM |
BIVV020 Complement C1s inhibitor |
SAR339375miRNA-21Alport Syndrome |
|
sutimlimabAnti Complement C1s mAb Cold Agglutinin
Disease |
|
|
O |
REGN4018(**)(2)Anti-MUC16xCD3
bispecific mAbOvarian Cancer |
SAR443060(**)(8) RIPK1
inhibitor(9)Amyotrophic Lateral Sclerosis |
|
|
efpeglenatide(**)(17) Long-acting
GLP-1 agonist Type 2 Diabetes |
|
|
SAR439859 SERDMetastatic Breast Cancer |
SAR443122(**)(8) RIPK1
inhibitor(9) Systemic inflammatory diseases |
|
|
nirsevimab(**)(18) Respiratory
syncytial virusMonoclonal Antibody |
|
SAR442720(**)(3) SHP2 inhibitorSolid Tumors |
Next Gen
PCV(**)(10) Pneumococcal
Conjugate Vaccines |
|
|
|
|
SAR440234 T cell engaging multi spe
mAbLeukemia |
Herpes Simplex Virus Type
2(**)(19) HSV-2 therapeutic vaccine |
|
|
|
|
SAR441000(**)(4)
Cytokine mRNASolid tumors |
Respiratory syncytial virus Infants 4-month and
older Vaccines |
|
|
|
|
SAR442085 Anti CD38 mAb Fc engineered
Multiple Myeloma |
SAR441169(**)(11)
RORC (ROR gamma T) antagonist, Psoriasis |
|
|
|
|
O |
REGN5459(**)(2)Anti-BCMAxCD3 bispecific
mAbRelapsing Refractory MM |
SAR441236 Tri-specific neutralizing
mAbHIV |
|
|
|
|
|
- Developed in collaboration with Immunext
- Regeneron product for which Sanofi has opt-in rights
- Developed in collaboration with Revolution Medicines
- Developed in collaboration with BioNtech
- Developed in collaboration with SOBI
- Recombinant Coagulation Factor VIII Fc – von Willebrand Factor
– XTEN Fusion protein
- Developed in collaboration with Sangamo
- Developed in collaboration with Denali
- Receptor-interacting serine/threonine-protein kinase 1
- Developed in collaboration with SK
- Developed in collaboration with Lead Pharma
- Developed in collaboration with Regeneron
- Acid Sphingomyelinase Deficiency also known as Niemann Pick
type B
|
- Identification of out-licensing partner ongoing
- Developed in collaboration with Principia
- Autosomal Dominant Polycystic Kidney Disease
- Developed in collaboration with Hanmi
- Developed in collaboration with AstraZeneca
- Developed in collaboration with Immune Design/Merck
O : Opt-in rights products for which rights have not been
exercised yetR : Registrational Study (other than Phase 3) (*)
Phase of projects determined by clinicaltrials.gov disclosure
timing when relevant(**) Partnered and/or in collaboration – Sanofi
may have limited or shared rights on some of these productsmAb =
monoclonal antibody; MM = Multiple Myeloma; RR = Relapsing
Refractory; GCS = glucosylceramide
synthase |
Additional Indications(*)
Phase 1 (Total : 5) |
Phase 2 (Total : 16) |
Phase 3 (Total : 24) |
Registration (Total : 2) |
SAR439459 + cemiplimab(**)(1) Advanced Solid
Tumors |
dupilumab(**)(1) Grass pollen allergy |
isatuximab + cemiplimab(**)(1) Relapsing
Refractory MM |
Dupixent® (**)(1) Asthma 6 - 11 years old |
isatuximabNewly Diag. MM Te(8) (GMMG) |
Fluzone® QIV HD Influenza vaccine - High dose |
O |
cemiplimab(**)(1) + REGN4018(2)(**)Ovarian
Cancer |
R |
sarilumab(**)(1) Polyarticular JIA(6) |
isatuximab + cemiplimab(**)(1) Lymphoma |
dupilumab(**)(1) Eosinophilic Esophagitis |
isatuximab 2L RRMM (IKEMA) |
MenQuadfi TM U.S. 2y+ , EU
1y+ |
|
|
SAR439859 +
palbociclib(3)Metastatic Breast
Cancer |
R |
sarilumab(**)(1) Systemic Juvenile Arthritis |
isatuximab + atezolizumab(7) mCRC |
Dupixent®(**)(1) AD 6 – 11 years old |
Aubagio® Relapsing MS –
Pediatric |
|
|
sutimlimab ImmuneThrombocytopenic Purpura |
SAR440340(**)(1) COPD |
isatuximab + atezolizumab(7) Solid Tumors |
Dupixent®(**)(1) AD 6 months - 5
years old |
Lemtrada® RRMS - Pediatric |
|
SAR443060(4)Multiple sclerosis |
dupilumab(**)(1) Peanut Allergy - Pediatric |
venglustatFabry Disease |
sarilumab(**)(1)
Giant Cell Arteritis |
Cerdelga®Gaucher T1, ERT switch
Pediatric |
|
SAR442720(**)(5) +
cobimetinib Relapsed Refractory solid
tumors |
SAR440340(**)(1) Asthma |
venglustatGaucher Type 3 |
sarilumab(**)(1) Polymyalgia
Rheumatica |
Praluent®
(**)(1)LDL-C reduction - Pediatric |
|
|
R |
cemiplimab(**)(1)2L Basal Cell Carcinoma |
venglustatParkinson’s Disease with an associated
GBA mutation |
dupilumab(**)(1) COPD |
Praluent®
(**)(1)LDL-C reduction - HoFH |
|
|
|
isatuximab1-2L AML / ALL pediatrics |
SP0173 Tdap booster US |
cemiplimab(**)(1)1L NSCLC |
MenQuadfi TM US / EU 6w+ |
|
|
|
|
cemiplimab(**)(1)+ chemotherapy1L NSCLC |
Pediatric pentavalent vaccine Japan |
|
|
|
|
cemiplimab(**)(1)2L Cervical Cancer |
Shan 6 Pediatric hexavalent vaccine |
|
|
|
|
cemiplimab(**)(1)Adjuvant in CSCC |
VerorabVax® (VRVg) Purified vero rabies
vaccine |
|
|
|
|
fitusiran Hemophilia A and B pediatric |
isatuximab 1L Newly Diag. MM Ti(9) (IMROZ) |
|
- Developed in collaboration with Regeneron
- Regeneron product for which Sanofi has opt-in rights
- Pfizer product (palbociclib)
- Developed in collaboration with Denali
- Developed in collaboration with Revolution Medicines -
cobimetinib is a Genentech product
- Polyarticular JIA = Polyarticular Juvenile Idiopathic
Arthritis
- Studies in collaboration with Genentech Inc.
(atezolizumab)
- Transplant eligible
- Transplant ineligible
(*) Phase of projects determined by clinicaltrials.gov
disclosure timing when relevant(**) Partnered and/or in
collaboration - Sanofi may have limited or shared rights on some of
these products O : Opt-in rights
products for which rights have not been exercised
yet R : Registrational Study
(other than Phase 3)COPD = chronic obstructive pulmonary disease;
AML = acute myeloïd leukemia; ALL = acute lymphoblastic leukemia;
MM = multiple myloma;RRMS = Relapsing / Remitting Multiple
Sclerosis |
Expected Submission
Timeline(1)
NMEs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SAR442168(**)(8)
Multiple Sclerosis |
SAR339375Alport Syndrome |
|
sutimlimabCold Agglutinin Disease |
avalglucosidase alfa Pompe Disease |
|
|
SAR408701 2-3LNSCLC |
romilkimab Systemic scleroderma |
nirsevimab (9)(**) Respira. Syncytial Virus |
|
fitusiran Hemophilia A/B |
olipudase alfa ASD(4) |
efpeglenatide(**)(5)Type 2
Diabetes |
venglustatADPKD(6) |
BIVV001(**)(7)Hemophilia A |
SAR440340(**)(3)Atopic Dermatitis |
HIV vaccine |
|
2019(2) |
2020(2) |
2021(2) |
2022(2) |
2023(2) and beyond |
ADDITIONAL INDICATIONS |
Dupixent®(**)(3) AD 6 - 11 years
old |
isatuximab2L RRMM (IKEMA) |
Aubagio® Relapsing MS – Ped |
isatuximab1L Newly Diag MM Ti |
Dupixent®(**)(3) AD 6 m - 5 y
old |
Cerdelga®Gaucher T1, ERT switch,
Ped |
SAR440340(**)(3) COPD |
isatuximabNewly Diag MM Te |
|
cemiplimab(**)(3) 2L BCC |
Shan 6 Ped hexavalent vaccine |
cemiplimab(**)(3) 2L Cervical Cancer |
venglustatGaucher Type 3 |
sarilumab(**)(3) Polym.Rheumatica |
SAR440340(**)(3)Asthma |
venglustatGBA-PD10) |
|
Praluent®(**)(3)LDL-C
reduction, HoFH |
|
sarilumab(**)(3) Polyarticular JIA |
Praluent®(**)(3)LDL-C
reduction – Ped |
sarilumab(**)(3) Giant Cell
Arteritis |
dupilumab(**)(3)Eosinophil. esophagitis |
venglustatFabry Disease |
|
|
|
Dupixent® (**)(3) Asthma 6 - 11 y old |
cemiplimab(**)(3)1L NSCLC |
|
Pediatric pentavalent vaccine (Japan) |
VerorabVax® (VRVg) Purified vero rabies
vaccine |
|
|
|
|
|
|
MenQuadfiTM U.S.& EU 6w+ |
SP0173 Tdap booster US |
|
|
|
|
|
|
Lemtrada® RRMS ped |
dupilumab(**)(3)COPD |
|
|
|
|
|
|
|
isatuximab1-2L AML / ALL ped |
cemiplimab(**)(3) adjuvant in CSCC |
|
|
|
|
|
|
|
cemiplimab(**)(3) + chemo 1L NSCLC |
sarilumab(**)(3) Systemic Juv. Arthri |
- Excluding Phase 1 without POC
- Projects within a specified year are not arranged by submission
timing
- Developed in collaboration with Regeneron
- Acid Sphingomyelinase Deficiency
- Developed in collaboration with Hanmi
- Autosomal Dominant Polycystic Kidney Disease
- Developed in collaboration with SOBI
- Developed in collaboration with Principia
- Developed in collaboration with AstraZeneca
- Parkinson’s Disease with an associated GBA mutation
(**) Partnered and/or in collaboration – Sanofi
may have limited or shared rights on some of these
products |
Pipeline Movements Since
Q2 2019
|
Additions & Moves |
Removals from Sanofi portfolio |
Registration |
|
|
|
|
|
|
|
|
Phase 3 |
|
|
|
|
|
|
|
|
Phase 2 |
|
|
isatuximab + cemiplimab(**)(4)
Anti-CD38 mAb + PD-1 inh mAb Advanced Malignancies |
|
|
|
|
|
Phase 1 |
SAR442085 Anti CD38 mAb Fc engineered
Multiple Myeloma |
SAR443122(**)(3)
RIPK1 inhibitor Systemic inflammatory diseases |
SAR441255 GLP1R/GIPR/GCGR agonist Obesity / Type 2
Diabetes |
|
O |
REGN5459(**)(1)Anti-BCMAxCD3 bispecific
mAbRelapsing Refractory MM |
BIVV020 Complement C1s inhibitor |
|
|
|
SAR442720(**)(2) + cobimetinib. Relapsed / refractory solid
tumors |
|
|
|
- Regeneron product for which Sanofi has opt-in rights
- Developed in collaboration with Revolution Medicines
- Developed in collaboration with Denali
- Developed in collaboration with Regeneron
(**) Partnered and/or in
collaboration – Sanofi may have limited or shared rights on some of
these
products
O : Opt-in rights products
for which rights have not been exercised yet
Appendix 7: Expected R&D
milestones
Products |
Expected milestones |
Timing |
Fluzone® QIV HD |
U.S. regulatory decision for ≥ 65-year
old age group |
Q4 2019 |
sutimlimab |
Pivotal trial read-out in Cold Agglutinin
Disease |
Q4 2019 |
SAR439859 (SERD) |
Proof of concept study read-out in 3L
metastatic Breast Cancer |
Q4 2019 |
sutimlimab |
Proof of concept study read-out in
ITP |
Q4 2019 |
SAR440340(**)(1) (anti-IL33 mAb) |
Proof of concept study read-out in
Chronic Obstructive Pulmonary Disease |
Q4 2019 |
isatuximab |
Pivotal trial read-out in 2L
Relapsed-Refractory Multiple Myeloma (IKEMA) |
Q1 2020 |
olipudase alfa |
Pivotal trial read-out in Acid
Sphingomyelinase Deficiency(3) |
Q1 2020 |
SAR442168(2)(**) (BTKi) |
Proof of concept study read-out in
Relapsing Multiple Sclerosis |
Q1 2020 |
cemiplimab |
Pivotal trial read-out in 2L Basal Cell
Carcinoma |
H1 2020 |
isatuximab |
U.S./ EU regulatory decisions in 3L
Relapsed-Refractory Multiple Myeloma |
Q2 2020 |
MenQuadfi™ |
U.S. regulatory decision for ≥ 2 year old
age group |
Q2 2020 |
Fluzone® QIV HD |
EU regulatory decision for ≥ 65-years old
age group |
Q2 2020 |
avalglucosidase alfa |
Pivotal trial read-out in Late Onset
Pompe Disease |
Q2 2020 |
SAR440340(**)(1) (anti-IL33 mAb) |
Proof of concept study read-out in Atopic
Dermatitis |
Q3 2020 |
- Developed in collaboration with Regeneron
- Developed in collaboration with Principia
- Also known as Niemann Pick type B
(**)
Partnered and/or in collaboration – Sanofi may have limited or
shared rights on some of these
products QIV:
Quadrivalent Influenza Vaccine; HD: High-Dose; ITP =
ImmuneThrombocytopenic Purpura
Appendix 8: Definitions of non-GAAP financial
indicators
Company
“Company” corresponds to Sanofi and its
subsidiaries.
Company sales at constant exchange rates
(CER)
When we refer to changes in our net sales “at
constant exchange rates” (CER), this means that we exclude the
effect of changes in exchange rates.
We eliminate the effect of exchange rates by
recalculating net sales for the relevant period at the exchange
rates used for the previous period.
Reconciliation of net sales to Company sales at constant
exchange rates for the third quarter and first nine months of
2019
€ million |
Q3 2019 |
9M 2019 |
Net sales |
9,499 |
26,518 |
Effect of exchange rates |
215 |
504 |
Company sales at constant exchange rates |
9,284 |
26,014 |
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)),
- effects of IFRS16 on lease
accounting,
- costs or provisions associated with
litigation(1),
- tax effects related to the items
listed above as well as effects of major tax disputes,
- net income attributable to
non-controlling interests related to the items listed above,
(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.
Grafico Azioni Sanofi (BIT:1SAN)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Sanofi (BIT:1SAN)
Storico
Da Giu 2023 a Giu 2024