Full Press Release Details
Response to COVID-19 global health crisis
Q1 2020 sales growth performance driven by Dupixent
R&D advances and regulatory milestones
| Q1 2020 | Change | Change at CER | ||||
| IFRS net sales reported | 8,973m | +6.9% | +6.6% | |||
| IFRS net income reported | 1,683m | +48.0% | - | |||
| IFRS EPS reported | 1.35 | +48.4% | - | |||
| Business operating income | 2,659m | +15.8% | +15.9% |
(1) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in
Appendix 9); (2) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in
Appendix 9). The consolidated income statement for Q1 2020 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (3) Base for business EPS growth is 5.97, reflecting 2
cents impact from IFRS 16 (Appendix 9).
2020 first-quarter Sanofi sales
Unless otherwise indicated, all percentage changes in sales in this document are stated at CER(5).
In the first quarter of 2020, Company sales were 8,973 million, up 6.9% on a reported basis. Exchange rate movements had a positive effect of 0.3 percentage points, mainly driven by the strength of the U.S. dollar and the Japanese yen,
partially offset by the decrease in the Brazilian real and the Argentine peso. At CER, Company sales increased 6.6%.
Global Business Units
With effect from January 1, 2020, Sanofi has structured its business into three core Global Business Units (GBUs) to support the
Company s strategy: Specialty Care, General Medicines and Vaccines. Its Consumer Healthcare business is in the process of being established as a standalone business with integrated R&D and manufacturing functions. The table below presents
first-quarter 2020 sales by Global Business Unit, including Consumer Healthcare, and by reporting region.
| Net sales by GBU ( million) | Q1 2020 | Change at CER | U.S. | Change at CER | Europe | Change at CER | Rest of the World | Change at CER | ||||||||||||||||||||||||
| Specialty Care | 2,695 | +31.3% | 1,639 | +36.8% | 589 | +21.2% | 467 | +27.2% | ||||||||||||||||||||||||
| Dupixent | 776 | +129.8% | 613 | +123.7% | 90 | +140.5% | 73 | +176.9% | ||||||||||||||||||||||||
| Multiple Sclerosis/ Neurology/Other I&I | 645 | +13.2% | 446 | +17.9% | 151 | +2.7% | 48 | +9.3% | ||||||||||||||||||||||||
| Rare Disease | 794 | +11.2% | 280 | +6.3% | 268 | +9.9% | 246 | +18.5% | ||||||||||||||||||||||||
| Oncology | 186 | +28.7% | 83 | +19.4% | 71 | +36.5% | 32 | +37.5% | ||||||||||||||||||||||||
| Rare Blood Disorder | 294 | +3.6% | 217 | +1.9% | 9 | +80.0% | 68 | +3.2% | ||||||||||||||||||||||||
| General Medicines | 4,069 | -3.8% | 742 | -10.7% | 1,220 | +1.4% | 2,107 | -4.1% | ||||||||||||||||||||||||
| Diabetes | 1,282 | -1.2% | 375 | -18.0% | 325 | +4.8% | 582 | +9.3% | ||||||||||||||||||||||||
| Cardiovascular and Established Rx Products | 2,787 | -5.0% | 367 | -1.7% | 895 | +0.2% | 1,525 | -8.4% | ||||||||||||||||||||||||
| Vaccines | 909 | +3.7% | 288 | +2.9% | 153 | +0.7% | 468 | +5.1% | ||||||||||||||||||||||||
| Consumer Healthcare | 1,300 | +4.2% | 302 | -5.2% | 420 | +6.1% | 578 | +8.1% | ||||||||||||||||||||||||
| Total net sales | 8,973 | +6.6% | 2,971 | +13.1% | 2,382 | +6.5% | 3,620 | +2.1% |
First-quarter 2020 Pharmaceutical sales were up 7.5% to 6,764 million, mainly driven by
Dupixent and Aubagio , partially offset by the decline in Plavix sales in
| Net sales ( million) | Q1 2020 | Change at CER | ||||||
| Total Dupixent | 776 | +129.8% |
Dupixent (collaboration with Regeneron) generated sales
of 776 million in the first quarter (up 129.8%). In the U.S., Dupixent sales of
613 million (up 123.7%) were driven by continued growth in atopic dermatitis which benefited from increased penetration in adult and adolescent patients, together with rapid uptake in
asthma and the most recent launch in chronic rhinosinusitis with nasal polyposis (CRSwNP, approved in June 2019). In the U.S., Dupixent NBRx and TRx increased strongly compared to the first
quarter of 2019, growing at 76% and 118%, respectively. First-quarter sales of Dupixent in Europe rose to 90 million (up 140.5%)
driven by continued growth in atopic dermatitis in key markets and additional launches. In Japan, where sales were 41 million (up 166.7%), a governmental price decrease was implemented on
April 1. Dupixent is now launched in 38 countries for adult atopic dermatitis; among these, Dupixent is also launched in adolescent
atopic dermatitis in 12 countries, in asthma in 14 countries and in CRSwNP in 5 countries.
(5) See Appendix 9 for definitions of financial
Multiple Sclerosis/Neurology/Other Inflammation & Immunology
| Net sales ( million) | Q1 2020 | Change at CER | ||||||
| Aubagio | 541 | +21.3% | ||||||
| Lemtrada | 49 | -46.7% | ||||||
| Kevzara | 55 | +80.0% | ||||||
| Total Multiple Sclerosis/ Neurology/Other I&I | 645 | +13.2% |
First-quarter Multiple Sclerosis/Neurology/Other I&I sales increased 13.2% to 645 million.
Aubagio sales increased 21.3% to 541 million, driven by the U.S. (up
23.0% to 391 million) and European performance (up 21.4% to 118 million). Sales growth reflected increased demand, together with inventory
build some of which was partially related to COVID-19, and pricing.
In the first quarter, Lemtrada sales decreased 46.7% to 49 million due to lower sales in the U.S. (down 43.9% to
23 million) and in Europe (down 69.0% to 13 million), reflecting increased global competition and reduced new patient starts as a result of
Kevzara (collaboration with
Regeneron) sales were 55 million (up 80.0%) in the first quarter, of which 32 million was generated in the U.S. (up 72.2%) and 20 million in Europe (150.0%).
| Net sales ( million) | Q1 2020 | Change at CER | ||||||
| Myozyme / Lumizyme | 246 | +11.8% | ||||||
| Fabrazyme | 214 | +14.6% | ||||||
| Cerezyme | 189 | +9.7% | ||||||
| Aldurazyme | 67 | 0.0% | ||||||
| Cerdelga | 58 | +20.8% | ||||||
| Others Rare Disease | 20 | 0.0% | ||||||
| Total Rare Disease | 794 | +11.2% |
In the first quarter, Rare Disease sales increased 11.2% to
794 million. In Europe, sales were up 9.9% (to 268 million), with growth elevated by an increase in stock driven by the COVID-19 pandemic. In the U.S., Rare Disease sales were up 6.3% (to 280 million). Strong Rest of the World growth (up 18.5% to 246 million) reflected ongoing demand trends and favorable timing of favorable tenders.
First-quarter Gaucher (Cerezyme and Cerdelga ) sales increased 12.1% to 247 million. Cerezyme sales increased
9.7% to 189 million, sustained by strong performance in Rest of the World (up 20.9% to 76 million). Cerezyme growth was due to new patient starts and positive phasing of shipments in the Rest of the World. First-quarter Cerdelga sales increased
20.8% to 58 million, with sales up 41.2% in Europe (to 24 million) and up 7.1% in the U.S. (to
31 million). Cerdelga growth reflected new patient starts and competitive switches especially in Europe.
First-quarter Pompe (Myozyme /Lumizyme ) sales grew 11.8% to 246 million,mainly reflecting new patient starts and reduced competition from clinical trials enrolling patients.
In the Rest of the World, Myozyme /Lumizyme sales were up 28.3% to
55 million. In the U.S. and in Europe, Myozyme /Lumizyme sales increased 6.3% (to 87 million) and 8.4% (to 104 million), respectively.
First-quarter Fabry (Fabrazyme ) sales grew 14.6% to 214 million, driven by the Rest of the World (up 28.3% to 58 million). In the U.S. and Europe, Fabrazyme sales increased 7.4% (to 104 million) and 15.6% (to 52 million), respectively. Growth was driven by new patient starts, especially in Europe and the Rest of the World which also benefited from positive order phasing.
| Net sales ( million) | Q1 2020 | Change at CER | ||||||
| Jevtana | 138 | +22.5% | ||||||
| Fasturtec | 35 | +9.4% | ||||||
| Libtayo | 12 | - | ||||||
| Sarclisa | 1 | - | ||||||
| Total Oncology | 186 | +28.7% |
First-quarter Oncology sales increased 28.7% to
186 million driven by double-digit growth in all regions.
First-quarter Jevtana sales increased 22.5% to 138 million driven by the U.S. (up 23.4% to 60 million)
and Europe (up 18.6% to 51 million). Sales performance benefited from publication of the results of the CARD study in metastatic castration-resistant prostate cancer at ESMO (European Society
for Medical Oncology) and in the NEJM (New England Journal of Medicine) in September 2019. In the Rest of the World, Jevtana sales increased 28.6% (to
(collaboration with Regeneron) approved 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
hadex-U.S. sales of 12 million in the first quarter. Libtayo has been launched in 12
countries outside the U.S.. U.S. Libtayo sales are reported by Regeneron.
Sarclisa (isatuximab-irfc) was approved by the U.S. Food and Drug Administration (FDA), in combination with pomalidomide and dexamethasone (pom-dex) for the
treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor on March 2, 2020. The U.S. pre-launch
was impacted by COVID-19. Sarclisa also received marketing authorization in Switzerland. In addition, the European Medicines Agency s Committee
for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sarclisa in RRMM at the end of March.
| Net sales ( million) | Q1 2020 | Change at CER | ||||||
| Eloctate | 161 | -10.9% | ||||||
| Alprolix | 109 | +11.6% | ||||||
| Cablivi | 24 | ns | ||||||
| Total Rare Blood Disorder | 294 | +3.6% |
First-quarter sales of the Rare Blood Disorder franchise were
294 million, up 3.6%. First-quarter U.S. sales were 217 million, up 1.9%. Non U.S. sales were 77 million with Japan as the primary contributor.
Eloctate sales were 161 million in the first quarter, down 10.9%. U.S. sales were down 16.1% to
119 million as a result of ongoing competitive pressure. In the Rest of the World, first-quarter Eloctate sales increased 8.1% to 42 million.
were 109 million in the first quarter, up 11.6% driven by the U.S., where sales increased 15.7% to 83 million reflecting switches
from short acting therapies and conversion to prophylaxis treatment. In the Rest of the World, Alprolix sales were stable at
for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) generated first-quarter sales of 24 million. Sales of Cablivi in the U.S. and Europe were 15 million and 9 million, respectively. In
Europe, the product is commercially available in Germany, Denmark, Austria, Belgium, Netherlands, Italy and Finland. Additionally, Cablivi has a temporary license to be sold in France.
General Medicines GBU
| Net sales ( million) | Q1 2020 | Change at CER | ||||||
| Lantus | 724 | -6.6% | ||||||
| Toujeo | 257 | +20.9% | ||||||
| Total glargine | 981 | -0.7% | ||||||
| Apidra | 89 | +1.1% | ||||||
| Admelog | 50 | -27.3% | ||||||
| Soliqua | 37 | +68.2% | ||||||
| Other diabetes | 125 | -4.5% | ||||||
| Total Diabetes | 1,282 | -1.2% |
In the first quarter, global Diabetes sales decreased 1.2% to
1,282 million, due to lower glargine (Lantus and Toujeo ) sales in the
U.S. which were partly offset by increased sales in the Rest of the World and patient stockpiling due to the COVID-19 pandemic notably in Europe. First-quarter U.S. Diabetes sales were down 18.0% to 375 million, reflecting a continued decline in average U.S. glargine net prices. First-quarter sales in Europe increased 4.8% to
325 million driven by Toujeo . First-quarter sales in the Rest of the World were up 9.3% to
In the first quarter, Lantus sales were 724 million, down 6.6%. In the U.S., Lantus sales decreased 21.5%
to 230 million, mainly reflecting lower average net price. In Europe, first-quarter Lantus sales were 149 million, down 3.9% reflecting biosimilar glargine competition and patients switching to Toujeo . In the Rest of the World,
first-quarter Lantus sales increased 4.8% to 345 million driven by strong performance in China.
First-quarter Toujeo sales increased 20.9% to
257 million, driven by strong performance in Europe (up 22.0% to 100 million) mainly driven by patient switches from Lantus to Toujeo and in the Rest of the World (up 48.3% to 89 million). In the U.S.,
first-quarter Toujeo sales were 68 million, down 4.3% mainly reflecting lower average net price.
First-quarter Amaryl sales decreased 8.9% to
82 million, due to lower sales in China (down 13.2% to 33 million) reflecting the anticipated net price adjustments and inventory
reduction in the channel due to the second wave of the nationwide VBP (volume-based procurement) program which includes glimepiride (compound name of Amaryl ). As previously disclosed, Sanofi
opted not to bid with Amaryl and expects sales of Amaryl in China to decline significantly in 2020.
First-quarter Apidra sales increased 1.1% to
89 million. Lower sales in the U.S. (down 30.8% to 9 million) offset growth in the Rest of the World (up 9.5% to 46 million) and Europe (up 2.9% to 34 million).
Admelog (insulin lispro injection) generated sales of 50 million (down 27.3%) in the first quarter. Admelog sales in the U.S. were
44 million, down 31.7% due to the WAC price adjustment of -44% which took effect on July 1, 2019. Sanofi expects lower Admelog sales in 2020 due to the full-year impact of the U.S. WAC price adjustment.
Soliqua 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) and Suliqua sales increased
68.2% (to 37 million) of which 22 million (up 37.5%) was generated in the U.S.
Cardiovascular and Established Rx Products
| Net sales ( million) | Q1 2020 | Change at CER | ||||||
| Lovenox | 329 | -2.9% | ||||||
| Plavix | 273 | -32.7% | ||||||
| Aprovel /Avapro | 174 | -13.4% | ||||||
| Thymoglobulin | 85 | +3.7% | ||||||
| Multaq | 81 | 0.0% | ||||||
| Praluent | 73 | +28.6% | ||||||
| Renvela /Renagel | 71 | -11.4% | ||||||
| Synvisc /Synvisc-One | 58 | -16.2% | ||||||
| Mozobil | 54 | +20.5% | ||||||
| Eloxatin | 47 | -11.1% | ||||||
| Taxotere | 39 | -17.0% | ||||||
| Generics | 270 | -0.4% | ||||||
| Other | 1,233 | +2.5% | ||||||
| Total Cardiovascular and Established Rx Products | 2,787 | -5.0% |
In the first quarter, Cardiovascular and Established Rx Products sales decreased 5.0% to 2,787 million, primarily reflecting the decline in Plavix and Aprovel family
sales in China due to net price adjustments following the nationwide implementation of the VBP program in December. Excluding China, Cardiovascular and Established Rx Products sales increased 0.6%. Established Rx Products benefited from a favorable
impact from COVID-19 on sales of chronic disease treatments, which reflected longer duration prescriptions and patient stocking despite lower sales of hospital-administered therapies.
First-quarter Lovenox sales