Sanofi : Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1)
Paris, October 28, 2021
Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1)
Q3 2021 sales grew double digit to €10.4 billion (up 10.1%) due to strong growth from Dupixent®, Vaccines and CHC
- Specialty Care sales increased 20.2% with strong contribution from Dupixent® (+54.6% to €1,410 million)
- Vaccines up 16.5%, with record quarterly sales driven by differentiated flu vaccines and meningitis franchise recovery
- CHC increased 11.1% driven by growth of Pain care and Digestive Wellness categories
- General Medicines sales down 1.7% while transformation of business model supports core assets growth (up 4.5%)
Q3 2021 business EPS(2) growth of 19.1% at CER driven by sales performance and efficiencies
- Business EPS(2) was €2.18, up 19.1% on a reported basis
- BOI margin reached 34.1% up 2.2 ppts reflecting improvement in Gross margin and continued expense management
- IFRS EPS was €1.85 (up 19.4 %)
Progress on Corporate Social Responsibility strategy
- Carbon neutrality target accelerated to 2030; a 2050 net zero objective established
- Sanofi ranked #1 in the European pharma sector by ESG rating agency Vigeo Eiris (part of Moody’s ESG Solutions)
Key milestone and regulatory achievements on R&D transformation
- Positive pivotal phase 3 readouts for Dupixent® in chronic spontaneous urticaria and infant atopic dermatitis (6 months to 5 years)
- Nexviazyme® approvals in U.S. and Japan
- Submissions of sutimlimab in the U.S. and olipudase alfa in Japan under the Sakigake pathway
- Acquisition of Translate Bio completed, first positive clinical data read-out validating the mRNA platform
Full-year 2021 business EPS guidance revised upward(1)
- Sanofi now expects 2021 business EPS(2) to grow around 14% at CER(3), barring unforeseen major adverse events. Applying average October 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -3.5% to -4.5%
Sanofi Chief Executive Officer, Paul Hudson, commented:
“Sanofi has delivered outstanding financial results in the third quarter. Double-digit sales growth in the period was driven by the remarkable performance of Dupixent®, record sales of Vaccines and business momentum in Consumer Healthcare, all in line with our strategic priorities. As a result of our sales performance and strong earnings, we have upgraded our full-year EPS guidance growth to around 14% at CER. In R&D, our growing pipeline of potentially transformative therapies has progressed, including the most recent positive readouts for Dupixent® in Eosinophilic esophagitis and Prurigo nodularis as well as the U.S. approval and launch of Nexviazyme® in Pompe disease. With higher R&D investment behind our pipeline assets and the two targeted bolt-on acquisitions of Translate Bio and Kadmon, we have further increased our commitment to bring innovative medicines to patients and drive future growth. Aligned with our contract with society and leading up to COP 26, we have set ourselves new ambitious ESG targets to reduce carbon emissions and accelerate our actions in fighting global climate change.”
Q3 2021 | Change | Change at CER | 9M 2021 | Change | Change at CER | |
IFRS net sales reported | €10,432m | +10.1% | +10.1% | €27,767m | +4.2% | +8.2% |
IFRS net income reported(4) | €2,317m | +18.7% | _ | €5,093m | -54.7% | — |
IFRS EPS reported | €1.85 | +19.4% | _ | €4.07 | -54.6% | — |
Free cash flow(5) | €2,202m | +16.9% | _ | €5,555m | +1.9% | — |
Business operating income | €3,558m | +17.5% | +17,3% | €8,461m | +9.7% | +15.0% |
Business net income(2) | €2,736m | +19.0% | +18.8% | €6,484m | +11.4% | +16.9% |
Business EPS(2) | €2.18 | +19.1% | +19.1% | €5.18 | +11.6% | +17.2% |
Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7)
(1) Sanofi already raised its full-year 2021 business EPS growth guidance to around 12% at CER on July 29; (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 7). The consolidated income statement for Q3 2021 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (3) 2020 restated business EPS was €5.86; (4) 9M 2021 IFRS net income reported reflected capital gain from sales of Regeneron shares in Q2 2020; (5) Free cash flow is a non-GAAP financial measure (definition in Appendix 7)
2021 third-quarter and first nine months 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 third quarter of 2021, Sanofi sales were €10,432 million, up 10.1% on a reported basis. Exchange rate movements had a neutral effect, the negative impact of the U.S. dollar, Japanese yen and Turkish lira was offset by the increase of the Chinese Yuan and some other currencies.
In the first nine months Sanofi sales reached €27,767 million, up 4.2% on a reported basis. Exchange rate movements had a negative effect of 4.0 percentage points. At CER, company sales were up 8.2%.
Global Business Units
Third-quarter 2021 operating income
Third-quarter business operating income (BOI) increased 17.5% to €3,558 million. At CER, BOI increased 17.3%. The ratio of BOI to net sales increased 2.2 percentage points to 34.1% (34.0% at CER). In the first nine months, BOI increased 9.7% to €8,461 million. At CER, BOI increased 15.0%. The ratio of business operating income to net sales increased 1.6 percentage points to 30.5% (30.8% at CER).
Pharmaceuticals
Third-quarter 2021 Pharmaceutical sales increased 7.8% to €6,855 million, mainly driven by the Specialty Care portfolio (up 20.2%) with continued strong performance of Dupixent® while sales in General Medicines decreased 1.7%. In the first nine months, Pharmaceuticals sales increased 7.7% to €20,051 million reflecting the strong performance of Specialty Care and General Medicines core assets.
Specialty Care
Dupixent
Net sales (€ million) | Q3 2021 | Change at CER | 9M 2021 | Change at CER | ||||
Total Dupixent® | 1,410 | +54.6 | % | 3,700 | +52.5 | % |
In the third quarter, Dupixent® (collaboration with Regeneron) sales increased 54.6% to €1,410 million. In the U.S., Dupixent® sales of €1,061 million (up 47.7%) 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 45% (year-over-year) and new-to-brand prescriptions (NBRx) grew 23% despite fewer in-person physician visits, which remain slightly below the pre-COVID level. In Europe, third-quarter Dupixent® sales grew 78.4% to €173 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Japan, sales were €78 million (up 68.8%). In the first nine months, Dupixent® sales reached €3,700 million, up 52.5%.
Neurology and Immunology
Net sales (€ million) | Q3 2021 | Change at CER | 9M 2021 | Change at CER | ||||
Aubagio® | 483 | -3.8 | % | 1,477 | -1.7 | % | ||
Lemtrada® | 20 | -16.7 | % | 63 | -27.2 | % | ||
Kevzara® | 83 | +42.4 | % | 196 | +15.3 | % | ||
Total Neurology and Immunology | 586 | +0.3 | % | 1,736 | -1.4 | % |
In the third quarter, Neurology and Immunology sales remained stable to €586 million, reflecting strong Kevzara® sales which were offset by lower Aubagio® sales. In the first nine months, Neurology and Immunology sales were down 1.4% reflecting decreased sales of Lemtrada® and Aubagio.
Aubagio® sales decreased 3.8% in the third quarter to €483 million due to lower sales in the U.S. reflecting increased competition which was partially offset by higher sales in Europe and the Rest of the World.
Third-quarter Kevzara® (collaboration with Regeneron) sales increased 42.4% to €83 million due to an increase in global demand for IL-6 receptor blockers and the temporary tocilizumab shortage.
Rare Disease
Net sales (€ million) | Q3 2021 | Change at CER | 9M 2021 | Change at CER | ||||
Myozyme® / Lumizyme® | 266 | +10.4 | % | 749 | +8.4 | % | ||
Fabrazyme® | 209 | +3.4 | % | 621 | +5.7 | % | ||
Cerezyme® | 159 | +0.6 | % | 502 | +1.1 | % | ||
Aldurazyme® | 57 | +5.5 | % | 180 | +7.3 | % | ||
Cerdelga® | 64 | +5.0 | % | 187 | +10.9 | % | ||
Others Rare Disease | 24 | +4.3 | % | 69 | +10.8 | % | ||
Total Rare Disease | 779 | +5.4 | % | 2,308 | +6.1 | % |
In the third quarter, Rare Disease sales increased 5.4% to €779 million driven by Pompe franchise performance. In the first nine months, sales of Rare Disease increased 6.1% reflecting growth across all three geographic regions.
Third-quarter Myozyme®/Lumizyme® sales increased 10.4% to €266 million supported primarily by new patient accruals across geographic regions.
Third-quarter Fabrazyme® sales increased 3.4% to €209 million driven by higher demand in Europe and the Rest of the World region, reflecting new patient accruals and improved treatment compliance.
Sales of the Gaucher franchise (Cerezyme® + Cerdelga®) increased 1.8% (to €223 million) in the third quarter. Over the period, Cerezyme® sales increased 0.6% to €159 million, reflecting growth in the U.S. and Rest of World region. In Europe Cerezyme® sales were down 4.8% as Cerdelga® sales were up 5.0% globally driven by new patient accruals in Europe.
Oncology
Net sales (€ million) | Q3 2021 | Change at CER | 9M 2021 | Change at CER | ||||
Jevtana® | 105 | -20.9 | % | 345 | -10.9 | % | ||
Sarclisa® | 48 | +276.9 | % | 122 | +605.6 | % | ||
Fasturtec® | 37 | -9.5 | % | 111 | +1.8 | % | ||
Libtayo® | 35 | +61.9 | % | 94 | +95.8 | % | ||
Total Oncology | 225 | +8.1 | % | 672 | +19.3 | % |
Third-quarter and first-nine months sales of Oncology increased 8.1% (to €225 million) and 19.3%, respectively, driven by the Sarclisa® and Libtayo® launches which more than offset the impact of Jevtana® generic competition in Europe.
Third-quarter Jevtana® sales decreased 20.9% to €105 million following the entry of generic competition in certain European markets (down 58.3%) at the end of March. In the U.S., sales were up 1.6%, where the Jevtana® composition of matter patent has expired in September 2021. However, Sanofi has filed patent infringement suits against generic filers on Jevtana® under Hatch-Waxman in the U.S. District Court for the District of Delaware asserting three method of use patents, two of which (US 10,583,110 and US 10, 716,777) expire in October 2030 and the other one (US 8,927,592) expires in April 2031 including 6-month pediatric exclusivities. Sanofi has reached settlement agreements with some of the defendants and the suit against the remaining defendants is ongoing. No trial dates has been scheduled and the remaining defendants have agreed not to launch any generic cabazitaxel product until the earlier of a district court decision in favor of the defendants or four months after the completion of the post-trial briefing. Separately, Jevtana® has been granted a data exclusivity on the CARD clinical study results which expires in December 2023.
Third-quarter Sarclisa® sales were €48 million (versus €13 million in the third quarter of 2020) driven by additional country launches in Europe (€17 million), higher sales in the U.S (€18 million) and in the Rest of the world region (€13 million) driven by the uptake in Japan.
Libtayo® (collaboration with Regeneron) sales were €35 million (up 61.9%) in the third quarter driven by increased demand in metastatic cutaneous squamous cell carcinoma (CSCC) as well as additional country launches. Libtayo® sales in the U.S. are reported by Regeneron.
Rare Blood Disorders
Net sales (€ million) | Q3 2021 | Change at CER | 9M 2021 | Change at CER | ||||
Eloctate® | 144 | -4.6 | % | 422 | -7.3 | % | ||
Alprolix® | 101 | -6.4 | % | 301 | -4.8 | % | ||
Cablivi® | 42 | +32.3 | % | 126 | +56.6 | % | ||
Total Rare Blood Disorders | 287 | -1.4 | % | 849 | -0.4 | % |
In the third quarter, Rare Blood Disorders franchise sales decreased 1.4% (€287 million). Excluding industrial sales to Sobi, third-quarter sales were up 7.1% mainly driven by 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. In the first nine months sales of Rare Blood Disorders decreased 0.4% and were up 9.8.% when excluding industrial sales to Sobi.
Eloctate® sales were €144 million in the third quarter, down 4.6%. Excluding industrial sales to Sobi, Eloctate sales were up 2.2% driven by higher U.S. sales (+3.7%) which benefited from buying patterns in the quarter . Sales in the Rest of the World were down 25.0% reflecting lower industrial sales to Sobi (which are recorded in this region).
Third-quarter Alprolix® sales were down 6.4% to €101 million. Excluding industrial sales to Sobi, Alprolix® sales were up 6.3% driven by U.S. sales (up 5.0%) which benefited from buying patterns in the quarter. Sales in the Rest of the World were down 37.9% reflecting lower industrial sales to Sobi (which are recorded in this region).
Cablivi® generated sales of €42 million (up 32.3%) in the third quarter driven by launches in Europe (up 120.0% to €22 million). In the U.S., sales of the product were €19 million, down 9.5% reflecting the impact of the COVID-19 environment on treatment initiations with Cablivi® at the hospital level.
General Medicines
Third quarter General Medicines sales decreased 1.7% to €3,568 million. The growth of core assets2 (up 4.5% to €1,437 million and up 5.6% excluding Praluent® U.S. sales) was more than offset by the non-core assets sales decrease (down 6.3% to €1,923 million) mainly reflecting lower Lantus® sales in the U.S., portfolio streamlining (-1.3 ppt impact) and a decline in Aprovel®/Avapro® sales. Third-quarter Industrial sales3 were €208 million up 2.5%. Excluding portfolio streamlining, third quarter General Medicines sales were down 0.7% (- 1.0 ppt impact).
In the first nine months, General Medicines sales were down 0.6% to €10,786 million. During the same period, sales of the core assets were €4,339 million up 6.8%, driven by strong performance of Lovenox®, Toujeo® and Thymoglobulin®. Non-core assets sales were €5,859 million, down 5.8% reflecting portfolio streamlining (-2.0 ppt), as well as lower Lantus® and Aprovel®/Avapro® sales. Over the same period, Industrial sales were €588 million up 4.2%. Excluding portfolio streamlining, General Medicines sales were up 0.5 % (-1.1 ppt impact).
Diabetes
Net sales (€ million) | Q3 2021 | Change at CER | 9M 2021 | Change at CER | ||||
Lantus® | 622 | -5.9 | % | 1,911 | -4.1 | % | ||
Toujeo® | 239 | +11.1 | % | 739 | +7.9 | % | ||
Total glargine | 861 | -1.7 | % | 2,650 | -1.0 | % | ||
Soliqua® | 51 | +27.5 | % | 141 | +28.7 | % | ||
Other diabetes | 211 | -6.6 | % | 653 | -3.7 | % | ||
Total Diabetes | 1,123 | -1.7 | % | 3,444 | -0.6 | % |
In the third quarter, global Diabetes sales decreased 1.7% to €1,123 million. Sales growth in the Rest of the Word (up 9.3%) was more than offset by lower sales in the U.S. (down 13.4%) and Europe (down 3.2%). In the first nine months, Diabetes sales were down 0.6% mainly as a result of lower Lantus® sales partially offset by growth from Toujeo® and Soliqua®.
Third-quarter Toujeo® sales increased 11.1% to €239 million reflecting growth across all geographies and strong growth in the Rest of World region (up 20.0%).
Lantus® sales were €622 million, down 5.9% in the third quarter, reflecting lower sales in the U.S. and Europe due to a continued decline in average U.S. net price, increasing use of Toujeo® and biosimilar glargine competition. In the Rest of World region, Lantus® sales were up 10.1% driven by China.
Third-quarter Soliqua® sales increased 27.5% to €51 million driven by growth in all three geographic regions. In the Rest of World region, third-quarter Soliqua® sales grew 40.0% mainly due to new launches.
Cardiovascular and Established Rx Products
Net sales (€ million) | Q3 2021 | Change at CER | 9M 2021 | Change at CER | ||||
Lovenox®* | 383 | +4.4 | % | 1,151 | +19.1 | % | ||
Plavix®* | 222 | +6.3 | % | 707 | +1.0 | % | ||
Aprovel®/Avapro® | 107 | -21.8 | % | 307 | -29.4 | % | ||
Thymoglobulin® | 91 | +4.6 | % | 263 | +16.1 | % | ||
Multaq® | 79 | 0.0 | % | 230 | +4.3 | % | ||
Praluent® | 59 | +18.0 | % | 163 | -15.8 | % | ||
Mozobil® | 60 | +7.1 | % | 170 | +13.5 | % | ||
Generics | 172 | -10.9 | % | 566 | -0.3 | % | ||
Other | 1,064 | -4.0 | % | 3,197 | -5.0 |
By: GlobeNewswire
- 28 Oct 2021
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