Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

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Algemeen advies 28/04/2021 08:34
Sanofi continued its growth trajectory.
Strong increase in Q1 2021 business EPS(1) at CER.

Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent® and Vaccines

Specialty Care sales grew 15.3%, due to strong Dupixent® performance (+45.6% to €1,047 million) and oncology launches
Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere
General Medicines core assets grew 4.4%, while GBU sales were down 3.8%
CHC decreased 7.3% due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe
Q1 2021 business EPS(1) growth at CER driven by efficiency and sales performance, supported by a one-time payment

Business EPS(1) was €1.61 up 5.2% on a reported basis and up 15.0% at CER
Business EPS(1) includes an incremental 8 cents due to a payment related to the termination of a collaboration in Japan
IFRS EPS was €1.25
Progress on implementation of the Corporate Social Responsibility strategy

Sanofi has become a member of the top five companies of the 2021 Access to Medicine index
Sanofi announced Sanofi Global Health, a newly formed non-profit unit within the company, a new cornerstone of its CSR strategy
Full-year 2021 business EPS guidance affirmed

Sanofi expects 2021 business EPS(1) to grow high single digit(2) at CER, barring unforeseen major adverse events. Applying average April 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -4% to -5%.
Sanofi Chief Executive Officer, Paul Hudson, commented:

“Our strong first-quarter performance is the result of the continued execution of our Play to Win strategy to drive growth and bring innovative medicines to patients. Dupixent® continues its outstanding performance with impressive growth in the U.S. and strong uptake in global markets, including China. Vaccines delivered growth in its core segments. We initiated and completed enrollment of our Phase 2 study for our recombinant COVID-19 vaccine candidate in the first quarter and results are expected next month. Following the communication of our ESG strategy at the end of 2020 and embedding it into our business priorities, we have recently created the Sanofi Global Health Unit, dedicated to increasing access to 30 medicines considered essential by the WHO. Sanofi is uniquely positioned to make this difference to society, which can be scaled and sustained over time, given our portfolio of essential medicines and broad geographic presence.”

Q1 2021 Change Change
at CER
IFRS net sales reported €8,591m -4.3% +2.4%
IFRS net income reported €1,566m -7.0% _
IFRS EPS reported €1.25 -7.4% _
Free cash flow(3) €1,925m +23.6% _
Business operating income €2,638m +4.0% +13.3%
Business net income(1) €2,017m +5.1% +14.7%
Business EPS(1) €1.61 +5.2% +15.0%
Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7)
(1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7). The consolidated income statement for Q1 2021 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2020 restated business EPS was €5.86; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 7).

2021 first-quarter Sanofi sales

Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER1


In the first quarter of 2021, Sanofi sales were €8,591 million, down 4.3% on a reported basis. Exchange rate movements had a negative effect of 6.7 percentage points, mainly driven by the decrease of the U.S. dollar, Brazilian real, Russian ruble, Turkish lira, and Argentine peso and Japanese yen. At CER, Sanofi sales increased 2.4%.

Global Business Units

First-quarter 2021 net sales by Global Business Unit (variation at CER; € million; % of total sales).

First-quarter 2021 operating income

First-quarter business operating income (BOI) increased 4.0% to €2,638 million. At CER, BOI increased 13.3%. The ratio of BOI to net sales increased 2.4 percentage points to 30.7% versus the prior year.


First-quarter 2021 Pharmaceutical sales increased 3.8% to €6,563 million, with double-digit growth of the Specialty Care portfolio mainly driven by the strong performance of Dupixent® which largely offset lower sales in General Medicines in Europe and the U.S.

Specialty Care


Net sales (€ million) Q1 2021 Change
at CER
Total Dupixent® 1,047 +45.6 %

In the first quarter, Dupixent® (collaboration with Regeneron) sales were strong despite the COVID-19 environment and increased 45.6% to €1,047 million. In the U.S., Dupixent® sales of €793 million (up 41.6%) were driven by continued strong demand in atopic dermatitis (AD) in adult, adolescent patients, and children aged 6 to 11 years, continued uptake in asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent® total prescriptions (TRx) increased 51% (year-over-year) and new-to-brand prescriptions (NBRx) grew 16% despite fewer in-person physician visits which remain below the pre-COVID level. In Europe, first-quarter Dupixent® sales grew 52.2% to €137 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Japan, sales were €59 million (up 53.7%), where strong demand was moderated by the government price decrease implemented in April 2020. Dupixent® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. At the end of the first quarter, Dupixent® was launched in 49 countries with approximately 260 000 patients on therapy.

Neurology and Immunology

Net sales (€ million) Q1 2021 Change
at CER
Aubagio® 500 -1.1 %
Lemtrada® 24 -44.9 %
Kevzara® 57 +10.9 %
Total Neurology and Immunology 581 -3.4 %
In the first-quarter, Neurology and Immunology sales were down 3.4% to €581 million, impacted primarily by the decline of Lemtrada® sales.

Aubagio® sales decreased 1.1% in the first quarter to €500 million, due to lower sales in the U.S. reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe.

First-quarter Lemtrada® sales decreased 44.9% to €24 million, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada®.

First-quarter Kevzara® (collaboration with Regeneron) sales were up 10.9% to €57 million driven by Europe and Rest of the World which largely offset lower U.S. sales reflecting the recent strategic decision to reduce promotional efforts.

Rare Disease

Net sales (€ million) Q1 2021 Change
at CER
Myozyme® / Lumizyme® 235 +0.8 %
Fabrazyme® 208 +4.7 %
Cerezyme® 178 +4.2 %
Aldurazyme® 66 +7.5 %
Cerdelga® 62 +13.8 %
Others Rare Disease 21 +10.0 %
Total Rare Disease 770 +4.4 %
In the first quarter, Rare Disease sales increased 4.4% to €770 million, primarily driven by higher demand particularly in Rest of the World (up 10.2%). Sales in Europe increased 0.4% and compared to a high base in the first quarter of 2020 due to an inventory build related to the COVID-19 environment.

First-quarter Cerezyme® sales increased 4.2% to €178 million, driven by strong growth in Rest of the World (up 18.4%). First-quarter Cerdelga® sales increased 13.8% to €62 million driven by new patient accruals in the three regions. Sales of the Gaucher franchise (Cerezyme® + Cerdelga®) increased 6.5% (to €240 million) in the first quarter.

First-quarter Myozyme®/Lumizyme® sales increased 0.8% to €235 million supported by new patient accruals in the U.S. (up 11.5%) which offset lower sales in Europe and negative phasing effect in Rest of the World.

First-quarter Fabrazyme® sales increased 4.7% to €208 million driven by higher sales in Rest of the World and Europe. In the U.S. sales decreased 2.9% reflecting lower treatment compliance during the COVID-19 pandemic.


Net sales (€ million) Q1 2021 Change
at CER
Jevtana® 126 -2.9 %
Fasturtec® 35 +8.6 %
Libtayo® 26 +125.0 %
Sarclisa® 34 +3400.0 %
Total Oncology 221 +25.8 %
First-quarter Oncology sales increased 25.8% to €221 million, driven by the Sarclisa® and Libtayo® launches.

First-quarter Jevtana® sales decreased 2.9% to €126 million following the entry of generic competition in Europe (down 11.8%) at the end of March. In the U.S., sales were up 5.0%. In the U.S., the Jevtana® composition of matter patent will expire in September 2021. From May to July 2020, Sanofi filed patent infringement suits against all generic filers on Jevtana® under Hatch-Waxman in the U.S. District Court for the District of Delaware asserting two method of use patents (US 10,583,110 and US 10, 716,777), both of which expire in October 2030. Sanofi has reached settlement agreements with some of the defendants and the suit against the remaining defendants currently stayed. In Europe, generic competition has started in certain countries after the expiration of Jevtana®’s market exclusivity in March 2021.

Libtayo® (collaboration with Regeneron) sales were €26 million (up 125.0%) in the first quarter driven by increased demand in metastatic cutaneous squamous cell carcinoma (CSCC) as well as additional country launches. In February, Libtayo® was approved in two new indications in the U.S. as a monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ?50% and for patients with advanced basal cell carcinoma. Libtayo® sales in the U.S. are reported by Regeneron.

Sarclisa® was approved in March 2020 in the U.S. for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and in June by the European Commission in certain adults with RRMM. First-quarter Sarclisa® sales were €34 million driven by additional country launches. First-quarter sales in the U.S. and in Europe were €12 million and €13 million, respectively. In Rest of the World sales (€9 million) were driven by a strong performance in Japan. At the end of March, the FDA approved Sarclisa® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma.

Rare Blood Disorder

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