Sales growth accelerated - Full-year guidance raised
Paris, July 29, 2021
Sales growth accelerated - Full-year guidance raised
Q2 2021 sales grew double digit to €8.7 billion (up 12.4% at CER) mainly driven by Dupixent® and Vaccines
- Specialty Care sales increased 22.0%, due to strong Dupixent® (+56.6%) and new oncology
- Vaccines up 16.2%, driven by meningitis and boosters franchise recovery; accelerating the mRNA pipeline
- General Medicines sales increased 4.2% supported by core assets (up 11.8%) including COVID related demand for Lovenox®
- CHC increased 11.9% due to growth of Digestive Wellness category largely offsetting low demand for cough and cold brands
Q2 2021 business EPS(1) growth of 16.4% at CER driven by sales performance and efficiencies
- Business EPS(1) was €1.38, up 7.8% on a reported basis
- In H1 2021, cost savings of €450 million were realized of which the vast majority was reinvested
- IFRS EPS was €0.97 (down 84.0%), reflecting capital gain from sales of Regeneron shares in Q2 2020
Progress on implementation of the Corporate Social Responsibility strategy
- Increased representation of women in senior leadership positions to 40% (36% in Q2 2019) with an ambition of 50% by 2025
- A €3 million Planet Mobilization fund launched to support employee projects to improve our environmental impact
Key milestone and regulatory achievements on R&D transformation
- Global Phase 3 study of adjuvanted recombinant-protein COVID-19 vaccine candidate (collaboration with GSK) started
- All pivotal studies of nirsevimab read out successfully, global submissions to start in H1 2022, one year earlier than expected
- Formation of Vaccines mRNA center-of-excellence; flu vaccine candidate entered phase 1
- Additional regulatory approvals for Libtayo® and Sarclisa® in Europe
- Three acquisitions completed: Tidal Therapeutics, Kiadis and Kymab
Full-year 2021 business EPS guidance revised upward
- Sanofi now expects 2021 business EPS(1) to grow around 12% at CER(2), barring unforeseen major adverse events. Applying average July 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:
“The Sanofi business momentum has accelerated in the second quarter, delivering strong financial results driven by our core growth drivers Dupixent and Vaccines. We continue to deliver on our Play to Win strategy, and our second quarter performance gives us confidence in Sanofi’s growth trajectory for this year. Consequently, we are raising our full-year EPS guidance to around 12%. Significant progress was made across several clinical and regulatory milestones and in June, we formed the Sanofi mRNA vaccines Center of Excellence with the aim to lead the field in this next chapter of vaccine innovation. We are well on our way making Sanofi more representative of communities we serve, executing on our Diversity and Inclusion strategy and creating a work environment where our people can bring their best selves to transform the practice of medicine.”
Q2 2021 | Change | Change at CER | H1 2021 | Change | Change at CER | |
IFRS net sales reported | €8,744m | +6.5% | +12.4% | €17,335m | +0.9% | +7.2% |
IFRS net income reported | €1,210m | -84.1% | _ | €2,776m | -70.1% | — |
IFRS EPS reported | €0.97 | -84.0% | _ | €2.22 | -70.0% | — |
Free cash flow(3) | €1,428m | -29.0% | _ | €3,353m | -6.0% | — |
Business operating income | €2,265m | +5.5% | +13.8% | €4,903m | +4.7% | +13.6% |
Business net income(1) | €1,731m | +8.1% | +16.8% | €3,748m | +6.4% | +15.6% |
Business EPS(1) | €1.38 | +7.8% | +16.4% | €3.00 | +6.8% | +16.0% |
Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9)
(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 Q2 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 9).
2021 second-quarter and first-half 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 second quarter of 2021, Sanofi sales were €8,744 million, up 6.5% on a reported basis. Exchange rate movements had a negative effect of 5.9 percentage points, mainly driven by the decrease of the U.S. dollar, Japanese yen, Turkish lira, and Argentine peso. At CER, Sanofi sales increased 12.4%.
First-half Sanofi sales reached €17,335 million, up 0.9% on a reported basis. Exchange rate movements had a negative effect of 6.3 percentage points. At CER, Company sales were up 7.2%.
Global Business Units
Second-quarter 2021 operating income
Second-quarter business operating income (BOI) increased 5.5% to €2,265 million. At CER, BOI increased 13.8%. The ratio of BOI to net sales decreased 0.2 percentage points to 25.9% (26.5% at CER). First-half BOI increased 4.7% to €4,903 million. At CER, BOI increased 13,6%. The ratio of business operating income to net sales increased 1 percentage points to 28.3% (28.9% at CER).
Pharmaceuticals
Second-quarter 2021 Pharmaceutical sales increased 11.9% to €6,633 million, driven by a 22.0% growth of the Specialty Care portfolio sustained by the strong performance of Dupixent® while sales in General Medicines grew 4.2%. This performance also reflected the low base in the second quarter of 2020 where the impact of COVID-19 was compounded by the reversal of the stocking effect seen in the first quarter of 2020. First-half Pharmaceuticals sales increased 7.7% to €13,196 million reflecting the strong performance of Specialty Care.
Specialty Care
Dupixent
Net sales (€ million) | Q2 2021 | Change at CER | H1 2021 | Change at CER | ||||
Total Dupixent® | 1,243 | +56.6 | % | 2,290 | +51.4 | % |
In the second quarter, Dupixent® (collaboration with Regeneron) sales increased 56.6% to €1,243 million. In the U.S., Dupixent® sales of €947 million (up 48.9%) were driven by continued strong demand in atopic dermatitis (AD) in adults, adolescents, and children aged 6 to 11 years, and continued uptake in asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent® total prescriptions (TRx) increased 50% (year-over-year) and new-to-brand prescriptions (NBRx) grew 52% despite fewer in-person physician visits, which remain below the pre-COVID level. In Europe, second-quarter Dupixent® sales grew 79.8% to €152 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Japan, sales were €69 million (up 71.1%). First half Dupixent® sales reached €2,290 million, up 51.4%. At the end of the first half, Dupixent® was launched in 53 countries with greater than 300,000 patients on therapy.
Neurology and Immunology
Net sales (€ million) | Q2 2021 | Change at CER | H1 2021 | Change at CER | ||||
Aubagio® | 494 | -0.4 | % | 994 | -0.7 | % | ||
Lemtrada® | 19 | +5.3 | % | 43 | -30.9 | % | ||
Kevzara® | 56 | -6.5 | % | 113 | +1.7 | % | ||
Total Neurology and Immunology | 569 | -0.8 | % | 1,150 | -2.2 | % |
In the second quarter, Neurology and Immunology sales were down 0.8% to €569 million, reflecting lower Kevzara® and Aubagio® sales. In the first half, Neurology and Immunology sales were down 2.2% primarily due to lower sales of Lemtrada®.
Aubagio® sales decreased slightly (down 0.4%) in the second quarter to €494 million, due to lower sales in the U.S. reflecting increased competition which was almost offset by increased demand in Europe (including clinical trial supply) and higher sales in Rest of the World. In June, the European Commission (EC) approved Aubagio® for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis. This EC approval provides an additional year of marketing protection in the European Union.
Second-quarter Lemtrada® sales increased 5.3% to €19 million resulting from higher sales outside the U.S. and reflecting a low base in second quarter 2020 due to COVID-19.
Second-quarter Kevzara® (collaboration with Regeneron) sales were down 6.5% to €56 million due to lower sales in the U.S. and Rest of the World reflecting the recent strategic decision to reduce promotional efforts.
Rare Disease
Net sales (€ million) | Q2 2021 | Change at CER | H1 2021 | Change at CER | ||||
Myozyme® / Lumizyme® | 248 | +14.6 | % | 483 | +7.4 | % | ||
Fabrazyme® | 204 | +9.0 | % | 412 | +6.8 | % | ||
Cerezyme® | 165 | -1.7 | % | 343 | +1.4 | % | ||
Aldurazyme® | 57 | +9.1 | % | 123 | +8.2 | % | ||
Cerdelga® | 61 | +14.0 | % | 123 | +13.9 | % | ||
Others Rare Disease | 24 | +18.2 | % | 45 | +14.3 | % | ||
Total Rare Disease | 759 | +8.8 | % | 1,529 | +6.5 | % |
In the second quarter, Rare Disease sales increased 8.8% to €759 million, driven by higher demand in all three geographic regions and a low base for comparison in the second quarter of 2020 due to COVID-19. First-half sales of Rare Disease increased 6.5% reflecting growth across all three geographic regions.
Sales of the Gaucher franchise (Cerezyme® + Cerdelga®) increased 2.1% (to €226 million) in the second quarter. Second-quarter Cerezyme® sales decreased 1.7% to €165 million, reflecting lower sales in Rest of the World (down 11.7%) due to shipment phasing in Latin America which more than offset growth in Europe and the U.S. Second-quarter Cerdelga® sales increased 14.0% to €61 million driven by new patient accruals in the three geographic regions.
Second-quarter Myozyme®/Lumizyme® sales increased 14.6% to €248 million supported primarily by new patient accruals in the three geographic regions and improved treatment compliance in all three geographic regions.
Second-quarter Fabrazyme® sales increased 9.0% to €204 million driven by higher sales in Europe (up 17.4%), in Rest of the World (up 9.8%) and in the U.S. (up 4.9%) reflecting new patient accruals and improved treatment compliance in all geographies.
Oncology
Net sales (€ million) | Q2 2021 | Change at CER | H1 2021 | Change at CER | ||||
Jevtana® | 114 | -9.0 | % | 240 | -5.9 | % | ||
Sarclisa® | 40 | +975.0 | % | 74 | +1460.0 | % | ||
Fasturtec® | 39 | +8.1 | % | 74 | +8.3 | % | ||
Libtayo® | 33 | +120.0 | % | 59 | +122.2 | % | ||
Total Oncology | 226 | +25.4 | % | 447 | +25.6 | % |
Second-quarter and first-half sales of Oncology increased 25.4% (to €226 million) and 25.6%, respectively, driven by the Sarclisa® and Libtayo® launches which more than offset the impact of Jevtana® generic competition in Europe.
Second-quarter Jevtana® sales decreased 9.0% to €114 million following the entry of generic competition in certain European markets (down 26.8%) at the end of March. In the U.S., sales were up 6.3%, where the Jevtana® composition of matter patent will expire in September 2021. Between May and 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 is currently stayed.
Second-quarter Sarclisa® sales were €40 million (versus €4 million in the second quarter of 2020) driven by additional country launches. Sarclisa® is used together with two other combinations of medicines to treat adults with multiple myeloma who have at least received 1 prior therapy. Second-quarter sales in the U.S. and in Europe were €16 million and €14 million, respectively. Rest of the World sales (€10 million) were driven by strong performance in Japan.
Libtayo® (collaboration with Regeneron) sales were €33 million (up 120.0%) in the second quarter driven by increased demand in metastatic cutaneous squamous cell carcinoma (CSCC) as well as additional country launches. Libtayo® was also recently approved in the U.S. and Europe to treat patients with advanced basal cell carcinoma and as first-line treatment of patients with advanced non-small cell lung cancer with ?50% PD-L1 expression. Libtayo® sales in the U.S. are reported by Regeneron.
Rare Blood Disorder
Net sales (€ million) | Q2 2021 | Change at CER | H1 2021 | Change at CER | ||||
Eloctate® | 144 | -7.1 | % | 278 | -8.5 | % | ||
Alprolix® | 100 | -6.0 | % | 200 | -4.0 | % | ||
Cablivi® | 46 | +75.0 | % | 84 | +71.2 | % | ||
Total Rare Blood Disorder | 290 | +0.6 | % | 562 | — | % |
In the second quarter, Rare Blood Disorder franchise sales increased 0.6% (€290 million). Excluding industrial sales to Sobi, second-quarter sales were up 17.1% reflecting growth of Alprolix®, Eloctate® and Cablivi®. Alprolix® and Eloctate® industrial sales to Sobi are expected to be significantly lower in 2021 than in 2020 due to a change in the supply agreement. First-half sales of Rare Blood Disorder were stable and increased 11.1% when excluding industrial sales to Sobi.
Eloctate® sales were €144 million in the second quarter, down 7.1%. Excluding industrial sales to Sobi, Eloctate sales were up 6.8% driven by higher U.S. sales (+7.0%) which benefited from one-time higher inventory level as a result of as a result of the move to an integrated distribution system. Sales in the Rest of the World were down 37.0% reflecting lower industrial sales to Sobi (which are recorded in this region).
Second-quarter Alprolix® sales were down 6.0% to €100 million. Excluding industrial sales to Sobi, Alprolix® sales were up 15.8%, mainly driven by patient switches from standard half-life factors and prophylaxis conversion and also benefited from a low base for comparison due to the impact of COVID-19 in the second quarter of 2020. Sales in the Rest of the World were down 51.3% reflecting lower industrial sales to Sobi (which are recorded in this region).
Cablivi® generated sales of €46 million (up 75.0%) in the second quarter driven by increased disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. In the U.S., sales of the product were €21 million (up 27.8%). In Europe, sales were €25 million (up 150.0%) primarily driven by additional country launches.
General Medicines
Second quarter General Medicines sales increased 4.2% to €3,546 million driven by the performance of the core assets2 which were €1,428 million up 11.8% and up 14.9% excluding Praluent® U.S. sales (in the comparable quarter last year). This performance also reflected a low base for comparison due to the impact of COVID-19 in the second quarter of the prior year which was compounded by the reversal of the stocking effect seen in the first quarter of 2020. Non-core assets sales were €1,926 million, down 0.5% reflecting portfolio streamlining (-1.6 ppt) and lower Aprovel®/Avapro® sales impacted by a short-term supply constraint. Second-quarter Industrial sales were €192 million up 1.6%. Excluding portfolio streamlining, second quarter General Medicines sales were up 5.2% (-1,0 ppt impact).
First-half General Medicines sales were down 0.1% to €7,218 million. First-half sales of the core assets were €2,902 million up 7.9%, driven by strong performance of Lovenox®. Non-core assets sales were €3,936 million, down 5.6% reflecting portfolio streamlining (-2.4 ppt), as well as lower Lantus® and Aprovel®/Avapro® sales. First-half Industrial sales were €380 million up 5.1%. Excluding portfolio streamlining, first-half General Medicines sales were up 1.2% (-1,2 ppt impact).
Diabetes
Net sales (€ million) | Q2 2021 | Change at CER | H1 2021 | Change at CER | ||||
Lantus® | 637 | -2.7 | % | 1,289 | -3.2 | % | ||
Toujeo® | 247 | +7.9 | % | 500 | +6.5 | % | ||
Total glargine | 884 | 0.0 | % | 1,789 | -0.7 | % | ||
Soliqua® | 46 | +28.9 | % | 90 | +29.3 | % | ||
Other diabetes | 216 | +3.7 | % | 442 | -2.3 | % | ||
Total Diabetes | 1,146 | +1.6 | % | 2,321 | -0.1 | % |
In the second quarter, global Diabetes sales performance (up 1.6% to €1,146 million) was due to growth in all three geographic regions and also reflected the low base in the second quarter of 2020. In the U.S., Diabetes sales increased 2.8% driven by Lantus®. In Europe, sales increased 1.4% driven by Toujeo®. In the Rest of the World, sales were up 0.8%. First-half Diabetes sales were down 0.1% mainly as a result of lower Lantus® sales which more than offset the growth of Toujeo® and Soliqua®.
Second-quarter Toujeo® sales increased 7.9% to €247 million reflecting growth in Rest of the World mainly due to Toujeo® launch performance in China as well as the low base for comparison in Europe in the second quarter of 2020. In the U.S., Toujeo® sales decreased 14.7% and mainly due to net price declines in spite of continued volume growth.
Lantus® sales were €637 million, down 2.7% in the second quarter, mainly due to lower sales in Rest of the World and Europe as a result of more new patient starts onToujeo® and biosimilar glargine competition. Sales of Lantus® in the U.S increased 6.6% primarily due to higher volumes.
Second-quarter Soliqua® sales increased 28.9% to €46 million driven by growth in all three geographic regions mainly due to launches in Rest of the World (up 50.0%) and performance in Europe (up 40.0%). The SoliMix study met both primary endpoints with Soliqua® demonstrating non inferiority of blood sugar (HbA1c) reduction and superiority on body weight change from baseline compared to premixed insulin. The findings were presented at the American Diabetes Association (ADA) in June and simultaneously published in Diabetes Care.
Cardiovascular and Established Rx Products
Net sales (€ million) | Q2 2021 |
By: GlobeNewswire
- 29 Jul 2021
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