Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER
Q4 2020 sales growth(2) of 4.2% and business EPS growth of 9.8% at CER
- Specialty Care sales grew 18.3%, driven by strong Dupixent® performance (+54.2% to €982 million).
- Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH.
- General Medicines declined 7.5%, reflecting lower U.S. Diabetes sales, COVID environment and portfolio streamlining.
- CHC down 3.0% due to decreased sales of Cough & Cold related portfolio in Europe partially offset by Digestive Health brands.
- Leveraged business EPS as the result of prioritization within R&D and continued execution on smart spending initiatives.
- Sales down 2.4% and business EPS flat on a reported basis, as a result of the overall adverse impact from foreign currency rates.
Full-year 2020 performance
- Sales increased 3.3% to €36,041 million, driven by Dupixent® (€3,534 million, up 73,9%) and Vaccines.
- Business EPS of €5.86, up 3.9% on a reported basis and 9.2% at CER ahead of the guidance of 7% to 8%.
- In 2020, cost savings of €1,680 million were realized of which approximately 60% were reinvested .
- IFRS EPS of €9.82 (up 338.4%), reflecting capital gain from sales of Regeneron.
- Entering the sustainable finance landscape with two revolving credit facilities linked to selected sustainability KPIs.
- Board meeting held on February 4, proposes annual dividend of €3.20.
2021 financial outlook
- Sanofi expects 2021 business EPS(1) to grow high single digit(3) at CER, barring unforeseen major adverse events. Applying average January 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -4.5% to -5.5%.
Sanofi Chief Executive Officer, Paul Hudson, commented:
“While last year was an extraordinarily challenging year for all, I am incredibly proud of the measurable progress we made within the backdrop of a global pandemic. Our teams across the world have relentlessly delivered on our strategy with a sharpened focus on operating and financial efficiencies. We bolstered our R&D pipeline with the completion of the Synthorx and Principia acquisitions, met several regulatory milestones to bring our important medicines to patients, and have seen several proofs of concept which reassure us about the priorities we chose. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. At the same time we want to make a more immediate contribution to help saving lives, which is why we have decided to provide manufacturing support to BioNTech and Pfizer. The continuous uptake and potential of Dupixent® for patients, our contribution to population health with Vaccines, reinforced with the resiliency of our General Medicines and Consumer Healthcare portfolios are all solid foundations to build upon in 2021, helping us achieve our ambition of bringing breakthrough medicines and vaccines to people around the world.”
Q4 2020 | Change | Change at CER | 2020 | Change | Change at CER | |
IFRS net sales reported | €9,382m | (2.4%) | +4.2% | €36,041m | (0.2%) | +3.3% |
IFRS net income reported | €1,081m | N/A | — | €12,314m | +338.8%(5) | — |
IFRS EPS reported | €0.86 | N/A | — | €9.82 | +338.4% | — |
Free cash flow(4) | €1,530m | (27.5%) | — | €6,982m | +16.1% | — |
Business operating income | €2,052m | +0.3% | +9.9% | €9,762m | +4.4% | +9.7% |
Business net income(1) | €1,527m | (0.5%) | +9.4% | €7,347m | +4.2% | +9.6% |
Business EPS(1) | €1.22 | 0.0% | +9.8% | €5.86 | +3.9% | +9.2% |
(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 9). The consolidated income statement for Q4 2020 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9); (3) 2020 restated business EPS was €5.86; (4) Free cash flow is a non-GAAP financial measure (definition in Appendix 9); (5) includes capital gain from sales of Regeneron shares.
2020 fourth-quarter and full-year Sanofi sales
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Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER1
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In the fourth quarter of 2020, Sanofi sales were €9,382 million, down 2.4% on a reported basis. Exchange rate movements had a negative effect of 6.6 percentage points, mainly driven by the decrease of the U.S. dollar, Brazilian real, Turkish lira, Russian ruble, Mexican and Argentine pesos. At CER, Sanofi sales increased 4.2%.
Full-year 2020, Sanofi sales reached €36,041 million, down 0.2% on a reported basis. Exchange rate movements had a negative effect of 3.5 percentage points. At CER, Sanofi sales were up 3.3%.
Global Business Units
2020 fourth-quarter and full-year business operating income
Fourth-quarter business operating income (BOI) increased 0.3% to €2,052 million. At CER, BOI increased 9.9%. The ratio of BOI to net sales increased 0.6 percentage points to 21.9% versus the prior year. Full-year 2020, BOI increased 4.4% to €9,762 million. At CER, BOI increased 9.7%. The ratio of business operating income to net sales increased 1.2 percentage points to 27.1%.
1 See Appendix 9 for definitions of financial indicators.
Pharmaceuticals
Fourth-quarter 2020 Pharmaceutical sales increased 2.4% to €6,293 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 partially due to pricing pressures on the Diabetes franchise in the U.S. In 2020, Pharmaceuticals sales increased 3.1% to €25,674 million driven by the strong performance of Specialty Care.
Specialty Care
Dupixent
Net sales (€ million) | Q4 2020 | Change at CER | 2020 | Change at CER | ||||
Total Dupixent® | 982 | +54.2 | % | 3,534 | +73.9 | % |
In the fourth quarter, Dupixent® (collaboration with Regeneron) sales were strong despite the COVID-19 environment and increased 54.2% to €982 million. In the U.S., Dupixent® sales of €773 million (up 52.7%) were driven by continued strong demand in atopic dermatitis (AD) in adult and adolescent patients, rapid adoption in children aged 6 to 11 years (approved in May 2020), continued uptake in asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent® total prescriptions (TRx) increased 65% (year-over-year) and new-to-brand prescriptions (NBRx) grew 18% despite fewer in-person physician visits which remain below the pre-COVID level. In Europe, fourth-quarter Dupixent® sales grew 76.9% to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Japan, sales were €58 million (up 30.4%), 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 and will be listed on the NRDL (National Reimbursement Drug List) as of March 2021. In 2020, Dupixent® sales reached €3,534 million, up 73.9% reflecting increased penetration into eligible AD and asthma populations as well as expansion in additional geographies and new indications in younger populations. At the end of 2020, Dupixent® was launched in 47 countries with approximately 230 000 patients on therapy.
Multiple Sclerosis/Neurology/Other Inflammation & Immunology
Net sales (€ million) | Q4 2020 | Change at CER | 2020 | Change at CER | ||||
Aubagio® | 472 | +3.7 | % | 2,045 | +10.6 | % | ||
Lemtrada® | 21 | -60.3 | % | 113 | -58.7 | % | ||
Kevzara® | 60 | +16.7 | % | 236 | +30.3 | % | ||
Total Multiple Sclerosis/ Neurology/Other I&I | 553 | -1.3 | % | 2,394 | +3.9 | % |
In the fourth-quarter and full-year Multiple Sclerosis/Neurology/Other I&I sales were down 1.3% (to €553 million) impacted by the Lemtrada® sales decline. In 2020, the franchise’s sales were up 3.9% driven by Aubagio® and Kevzara® sales growth.
Aubagio® sales increased 3.7% in the fourth quarter to €472 million, driven by Europe (up 16.0%), mainly benefiting from demand growth and an earlier price increase in Germany. In the U.S., Aubagio® sales were stable reflecting lower new patient starts related to increased competition. Full-year 2020 Aubagio® sales increased 10.6% mainly driven by demand and price increases in the U.S and Germany.
Fourth-quarter and full-year Lemtrada® sales decreased 60.3% (to €21 million) and 58.7%, respectively, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada®.
?Fourth-quarter and full-year Kevzara® (collaboration with Regeneron) sales were up 16.7% (to €60 million) and 30.3%, respectively, reflecting growth in Europe and Rest of the World.
Rare Disease
Net sales (€ million) | Q4 2020 | Change at CER | 2020 | Change at CER | ||||
Myozyme® / Lumizyme® | 235 | +3.8 | % | 948 | +6.0 | % | ||
Fabrazyme® | 200 | -0.9 | % | 817 | +3.2 | % | ||
Cerezyme® | 160 | +0.6 | % | 690 | +4.5 | % | ||
Aldurazyme® | 57 | +13.0 | % | 234 | +8.5 | % | ||
Cerdelga® | 59 | +12.7 | % | 234 | +16.0 | % | ||
Others Rare Disease | 23 | +4.3% | 88 | +4.7% | ||||
Total Rare Disease | 734 | +3.0 | % | 3,011 | +5.7 | % |
In the fourth quarter, Rare Disease sales increased 3.0% to €734 million, primarily driven by demand partially offset by sales phasing. In 2020, Rare Disease sales increased 5.7% driven by Rest of the World.
Fourth-quarter Cerezyme® sales increased 0.6% to €160 million, driven by strong growth in Rest of the World. Fourth-quarter Cerdelga® sales increased 12.7% to €59 million driven by patient accruals in Europe. Sales of the Gaucher franchise (Cerezyme® + Cerdelga®) increased 3.4% (to €219 million) in the fourth quarter and 7.1% in 2020.
Fourth-quarter Myozyme®/Lumizyme® sales increased 3.8% to €235 million supported by new patient accruals in the U.S. In Rest of the World, sales decrease reflected COVID-19 impact on demand. Full-year 2020 Myozyme®/Lumizyme® sales increased 6.0% driven by new patient accruals in the U.S. and Rest of the World.
Fourth-quarter Fabrazyme® sales decreased 0.9% to €200 million reflecting lower sales in the Rest of the World, due to unfavorable order phasing. Fabrazyme® was launched in China in May and is the first treatment for Fabry disease approved in China. Full-year 2020 Fabrazyme® sales were up 3.2%, reflecting new patient accruals in Europe partially offset by COVID-19 impact and lower sales in Japan due to government price decrease in April 2020.
Oncology
Net sales (€ million) | Q4 2020 | Change at CER | 2020 | Change at CER | ||||
Jevtana® | 131 | +7.0 | % | 536 | +12.2 | % | ||
Fasturtec® | 38 | +2.6 | % | 152 | +12.3 | % | ||
Libtayo® | 19 | +66.7 | % | 67 | — | |||
Sarclisa® | 25 | — | 43 | — | ||||
Total Oncology | 213 | +24.6 | % | 798 | +27.1 | % |
Fourth-quarter Oncology sales increased 24.6% to €213 million, driven by Sarclisa® and Libtayo® launches and growth from established franchises. In 2020, Oncology sales were up 27.1% supported by growth in all three regions.
Fourth-quarter and full-year Jevtana® sales increased 7.0% to €131 million and 12.2%, respectively and benefited from increased demand in metastatic castration-resistant prostate cancer following publication of the results of the CARD study in this disease setting at ESMO (European Society for Medical Oncology) and in the NEJM (New England Journal of Medicine) in September 2019. 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 lasts until October 2030. Sanofi has reached settlement agreements with some of the defendants and the suit against the remaining defendants are ongoing. In Europe, generic competition is expected from end of March 2021.
Libtayo® (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 had ex-U.S. sales of €19 million in the fourth quarter and €67 million in 2020. Sales were driven by new country launches. To date, Libtayo® has been launched in 18 countries outside the U.S. Libtayo® sales in the U.S. are reported by Regeneron.
Sarclisa® was approved in March 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. Fourth-quarter Sarclisa® sales were €25 million of which €12 million was generated in the U.S. Sarclisa® is now launched in 12 countries (including the U.S., Japan, UK, Netherlands, Canada, Sweden, Switzerland and France).
Rare Blood Disorder
Net sales (€ million) | Q4 2020 | Change at CER | 2020 | Change at CER | ||||
Eloctate® | 156 | -6.8 | % | 638 | -5.7 | % | ||
Alprolix® | 131 | +27.8 | % | 466 | +15.0 | % | ||
Cablivi® | 30 | +93.8 | % | 113 | +105.4 | % | ||
Total Rare Blood Disorder | 317 | +11.0 | % | 1,217 | +7.1 | % |
In the fourth quarter and full-year Rare Blood Disorder franchise sales were up 11.0% (€317 million) and up 7.1%, respectively, driven by Alprolix® and Cablivi® performance which more than offset Eloctate® sales decline in the U.S. Excluding industrial sales of Alprolix® and Eloctate® to Sobi, fourth quarter and full-year Rare Blood Disorder sales grew 2.6% and 2.2%, respectively. Industrial sales to Sobi were higher than usual in the fourth quarter and full-year 2020 due to a change in the supply agreement (in 2020, sales to Sobi represented 17% and 11% of Alprolix® and Eloctate® sales, respectively). Alprolix® and Eloctate® industrial sales to Sobi are expected to be significantly lower in 2021.
Eloctate® sales were €156 million in the fourth quarter, down 6.8% due to lower U.S. sales (-10.6%) as a result of ongoing competitive pressure. Full-year Eloctate® sales decreased 5.7% driven by competitive pressure in the U.S partially offset by the Rest of the World (up 15.6%) which includes industrial sales to Sobi. Excluding industrial sales to Sobi, Eloctate® fourth quarter and full-year sales decreased 8.9% and 9.8%, respectively.
Fourth-quarter and full-year Alprolix® sales were up 27.8% (€131 million) and up 15.0%, mainly driven by patient switches from short-acting factors, prophylaxis conversion and increased industrial sales to Sobi. Full-year Alprolix® sales were up 15.0%. Excluding industrial sales to Sobi, Alprolix® fourth quarter and full-year sales each increased 6.3% and 7.4%, respectively.
Cablivi® for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) generated sales of €30 million in the fourth quarter of which €18 million from the U.S. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Full-year 2020 Cablivi® sales were €113 million of which €72 million from the U.S. In July, the International Society on Thrombosis and Haemostasis (ISTH) published the first evidence based global guidelines on the diagnosis and treatment of thrombotic thrombocytopenic purpura (TTP) in the Journal of Thrombosis and Haemostasis. The ISTH guidelines suggest treatment with Cablivi® in combination with plasma exchange and immunosuppressive therapy for first episode or relapse in all adult aTTP patients. In addition, real world evidence from three published manuscripts from over 230 patients with confirmed aTTP in France, the United Kingdom and Germany continues to demonstrate the benefits of using Cablivi® in combination with plasma exchange and immunosuppresive therapy. This growing body of data confirms HERCULES Phase 3 results and continues to support frontline use of Cablivi® for aTTP treament.
General Medicines
Diabetes
Net sales (€ million) | Q4 2020 | Change at CER | 2020 | Change at CER | ||||
Lantus® | 587 | (13.6 | %) | 2,661 | (8.5 | %) | ||
Toujeo® | 221 | 0.0 | % | 933 | 8.4 | % | ||
Total glargine | 808 | (10.3 | %) | 3,594 | (4.7 | %) | ||
Apidra® | 80 | (1.1 | %) | 332 | 1.7 | % | ||
Admelog® | 46 | (10.7 | %) | 188 | (23.2 | %) | ||
Soliqua® | 46 | 25.6 | % | 161 | +36.1 | % | ||
Other diabetes | 107 | (8.2 | %) | 434 | (11.2 | %) | ||
Total Diabetes | 1,087 | (8.4 | %) | 4,709 | (4.8 | %) |
In the fourth quarter, global Diabetes sales decreased 8.4% to €1,087 million, due to a continued decline in the average U.S. glargine price (Lantus® and Toujeo®), as well as some impact from the COVID-19 environment, mainly in the Rest of the World. Full-year 2020 franchise sales were down 4.8% mainly due to lower Lantus® and Admelog® sales in the U.S.and lower Amaryl® sales in China partly offset by Toujeo® and Suliqua® growth.
Lantus® sales were €587 million in the fourth quarter, down 13.6%. mainly due to a continued decline in average U.S. price, patients switching to Toujeo® and biosimilar glargine competition. In Rest of the World, sales decreased 4.1%, reflecting some COVID-19 impact on the out-of-pocket market as well as an unfavorable phasing effect. Full-year 2020 Lantus® sales decreased 8.5%, mainly due to lower sales in the U.S. and to a lesser extent in Europe, despite double-digit growth in China.
Fourth-quarter Toujeo® sales were stable at €221 million, as growth in Rest of the World and Europe offset lower sales in the U.S. In the U.S., fourth-quarter Toujeo® sales decreased 18.2% due to a continued decline in the average price which more than offset volume growth. Toujeo® was launched in China in the fourth quarter. In 2020, Toujeo® sales increased 8.4%, driven by strong performance in Rest of the World and Europe.
Fourth-quarter and full-year Amaryl® sales decreased 7.6% (€68 million) and 15.9%, respectively, due to lower sales in China reflecting the second wave of the VBP program which includes glimepiride (compound name of Amaryl®). As previously disclosed, Sanofi opted not to participate in the bidding for Amaryl®.
Fourth-quarter Soliqua®/Suliqua® sales increased 25.6% to €46 million driven by launches in Rest of the World. Full-year 2020 Soliqua® sales increased 36.1% supported by strong growth in all three regions.
Cardiovascular and Established Rx Products
Net sales (€ million) | Q4 2020 | Change at CER | 2020 | Change at CER | ||||
Lovenox® | 356 | +13.7 | % | 1,351 | +4.5 | % | ||
Plavix® | 202 | -1.4 | % | 916 | -30.1 | % | ||
Aprovel®/Avapro® | 115 | -9.2 | % | 554 | -15.9 | % | ||
Thymoglobulin® | 80 | -4.5 | % | 316 | -8.2 | % | ||
Multaq® | 79 | -14.1 | % | 312 | -8.4 | % | ||
Praluent® | 65 | -8.0 | % | 261 | +2.3 |
By: GlobeNewswire
- 05 Feb 2021
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