Donnerstag, 28.10.2021 07:30 von GlobeNewswire | Aufrufe: 424

Sanofi : Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1)

Eine Wissenschaftlerin bei einer Untersuchung. (Symbolbild) © Stas_Uvarov / iStock / Getty Images Plus / Getty Images

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


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  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


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


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).


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


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.


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).


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  %
Total Cardiovascular and Established Rx Products 2,237    -2.1  % 6,754    -1.0  %

*Excluding Auto generics

In the third quarter, Cardiovascular and Established Rx Products sales decreased 2.1% to €2,237 million. The performance of the core assets including Lovenox®, Plavix®, Thymoglobulin®, Mozobil® and Praluent® was more than offset by lower sales of Aprovel®/Avapro® and generics as well as the impact of the divestments of non-core products. In the first nine months, Cardiovascular and Established Rx Products sales were down 1.0% (up 0.1% excluding Praluent® U.S. sales) mainly due to lower Aprovel®/Avapro® sales and the divestments which offset strong growth of several core assets.

Third-quarter Lovenox® sales increased 4.4% to €383 million, driven by strong sales in Rest of World region (up 9.5%). COVID-19 related demand continued to be strong (guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients). However, growth performance was impacted by a comparable high base in the third quarter of 2020, supply limitations and biosimilar competition in Europe (down 1.8%).

Plavix® sales were up 6.3% in the third quarter to €222 million due to higher sales in Rest of World (up 9.2%) driven by China (up 16.7% to €90 million) largely offsetting lower sales in Japan and Europe.

Third-quarter Aprovel®/Avapro® sales were down 21.8% to €107 million reflecting supply constraints.

Third-quarter Praluent® sales increased 18.0% to €59 million, reflecting the restructuring of the collaboration with Regeneron effective April 1, 2020. Sanofi has sole responsibility for Praluent® outside the U.S. while Regeneron has sole responsibility for Praluent® in the U.S. Excluding U.S. sales in the comparable quarter last year, higher Praluent® sales (up 63.9%) were driven by the launch in China and strong performance in Europe.

Multaq® third quarter sales were stable at €79 million, reflecting U.S. sales growth which was offset by lower sales in Europe.

Pharmaceuticals business operating income

In the third quarter, business operating income (BOI) of Pharmaceuticals increased 2.8% to €2,409 million (up 1.7% at CER). The ratio of BOI to net sales decreased by 1.7 percentage points to 35.1%. At CER, the ratio decreased 2.0 percentage points reflecting Regeneron MAbs alliance and increased R&D expenses in priority assets and commercial expenses in Specialty Care growth drivers, despite an improvement of the gross margin ratio. In the first nine months, business operating income of Pharmaceuticals decreased 1.2% to €7,320 million (up 3.1% at CER). The ratio of BOI to net sales decreased by 1.7 percentage points to 36.5% (36.6% at CER).


Net sales (€ million) Q3 2021 Change
at CER
9M 2021 Change
at CER
Polio/Pertussis/Hib vaccines
(incl. Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®)
563    +1.8  % 1,616    +3.1  %
Influenza vaccines
(incl. Vaxigrip®, Fluzone HD®, Fluzone® & Flublok®)
1,339    +25.5  % 1,535    +23.9  %
Meningitis/Pneumo vaccines
(incl. Menactra®)
253    +18.7  % 567    +36.2  %
Adult Booster vaccines (incl. Adacel ®) 158    +4.6  % 364    +8.7  %
Travel and other endemic vaccines 82    +16.9  % 215    -1.3  %
Other vaccines 27   +8.7  % 62   +18.5 %
Total Vaccines 2,422    +16.5  % 4,359    +13.8  %

Third-quarter Vaccines sales grew 16.5% to €2,422 million driven by influenza vaccines performance and meningitis vaccination recovery in the U.S. In the first nine months, Vaccines sales grew 13.8% due to the strong performance of the influenza vaccines franchise and a recovery of meningitis vaccines more than offsetting the negative COVID-19 impact on the travel vaccines.

In the third quarter, Polio/Pertussis/Hib (PPH) vaccines sales increased 1.8% to €563 million. In Europe, PPH sales decreased 11.2% reflecting unfavorable phasing effect and lower birth rates due to the pandemic. In Rest of World, PPH sales were up 3.5% supported by Pentaxim® in China and Polio vaccines which largely offset the impact of lower birth rates. In the U.S., PPH sales increased 6.8% due to positive inventory fluctuation. VaxelisTM, the first and only hexavalent combination vaccine approved in the U.S., was launched in the U.S. in June 2021. Developed as part of a joint-partnership between Sanofi and Merck, VaxelisTM in-market sales are not consolidated and the profits shared equally between the two parties. As Vaxelis™ is expected to partly replace Pentacel® sales, PPH sales in the U.S. are expected to decrease going forward.

Influenza vaccines sales increased 25.5% in the third quarter to €1,339 million as a result of earlier shipments in the U.S and a strong increase in differentiated influenza vaccines in Europe driven by Germany which adopted a preferential recommendation for Efluelda® for people above 60 years old. Influenza vaccines sales in the U.S and in Europe grew 18.1% (to €982 million) and 87.8% (to €247 million), respectively.

Third-quarter Meningitis sales were up 18.7% to €253 million mainly with the recovery of meningitis vaccination in the U.S. and in Middle East in conjunction with the U.S. launch of MenQuadfi® in March 2021.

Adult Booster vaccines sales grew 4.6% in the third quarter to €158 million, due to the gradual recovery of Adacel® vaccinations in the U.S.

Third-quarter Travel and other endemic vaccines sales increased 16.9% versus a low 2020 basis.

Vaccines business operating income

In the third quarter, business operating income (BOI) increased 29.8% to €1,359 million reflecting the strong sales growth. At CER, BOI increased 29.5%. The ratio of BOI to net sales was 56.1% (versus 50.4% in the third quarter of 2020) reflecting a favorable product mix driven by influenza vaccines and Meningitis vaccines as well as good industrial performance. In the first nine months, BOI increased 30.7% (up 33.0% at CER) to €1,957 million reflecting strong sales performance as well as the payment from Daiichi Sankyo in the first quarter of 2021. The ratio of BOI to net sales increased 6.6 percentage points to 44.9% (44.7% at CER).

Consumer Healthcare

Net sales (€ million) Q3 2021 Change
at CER
9M 2021 Change
at CER
Allergy 142    +17.4  % 485    +2.2  %
Cough, Cold and Flu 94    +4.4  % 204    -30.9  %
Pain Care 290    +18.2  % 818    +7.3  %
Digestive Wellness 282    +16.0  % 855    +21.8  %
Physical Wellness 85    -7.7  % 244    -5.7  %
Mental Wellness 53    +8.2  % 160    +16.8  %
Personal Care 135    +5.4  % 387    +2.8  %
Non-Core / Others 74    +4.2  % 204    -5.8  %
Total Consumer Healthcare 1,155    +11.1  % 3,357    +4.2  %

In the third quarter, Consumer Healthcare (CHC) sales increased 11.1% to €1,155 million driven by growth in all three geographic regions and the performance of the Digestive Wellness category, as well as the Pain Care category which also benefited from COVID-19 vaccinations. In the first nine months CHC sales increased 4.2% mainly due to the growing sales in Digestive Wellness, Pain Care and Mental Wellness categories which more than offset a weak cough and cold season last winter and the divestments of non-core products (-0.6 ppt impact).

In the U.S., third-quarter CHC sales increased 16.4% to €289 million driven by strong growth of Pain Care, Personal Care (driven by Gold bond) and Digestive Wellness categories as well as Allergy which benefited from a low base for comparison.

In Europe, third-quarter CHC sales increased 3.1% to €335 million mainly reflecting growth of Pain Care and Digestive categories which more than offset lower sales from the Cough, Cold and Flu category due to the impact of social distancing measures.

In Rest of World, third-quarter CHC sales increased 13.9% to €531 million, supported by strong growth of Pain Care and Digestive Wellness categories as well as higher sales from the Allergy category.

CHC business operating income
In the third quarter, business operating income (BOI) of CHC increased 44.1% (44.4% at CER) to €464 million reflecting higher sales and a strict control of operational expenses. The ratio of BOI to net sales increased 9.3 percentage point to 40.2% versus the prior year and included a €77 million capital gain related to divestment of non-strategic assets. In the first nine months of 2021, BOI of CHC increased 8.0% (up 14.5% at CER) to €1,195 million. The ratio of BOI to net sales increased 2.7 percentage points to 35.6% (36.1% at CER).

Company sales by geographic region

Sanofi sales (€ million) Q3 2021 Change
at CER
9M 2021 Change
at CER
United States 4,477    +13.4  % 10,565    +13.4  %
Europe 2,483    +8.9  % 6,955    +5.3  %
Rest of the World 3,472    +6.7  % 10,247    +5.0  %
of which China 782    +12.8 % 2,162   +8.5 %
of which Japan 423    +13.3 % 1,253   +2.1 %
of which Brazil 198    +14.8 % 651   +16.7  %
of which Russia 139    -0.7  % 439    -3.8  %
Total Sanofi sales 10,432    +10.1  % 27,767    +8.2  %

Third-quarter sales in the U.S. increased 13.4% to €4,477 million supported by the strong performance of Dupixent® and double-digit growth of Vaccines and CHC. In the first nine months, U.S. sales grew 13.4%, mainly reflecting Dupixent® and Vaccines performance.

In Europe sales increased 8.9% in the third quarter to €2,483 million mainly driven by strong Vaccines growth and Dupixent® performance. In the first nine months, European sales increased 5.3% due to the growth of Specialty Care products driven by Dupixent® and Vaccines which more than offset lower sales of General Medicines and CHC.

In Rest of World sales increased 6.7% to €3,472 million in the third quarter, driven by the performance of Dupixent®, General medicine and CHC. Sales in China increased 12.8% to €782 million mainly sustained by Dupixent®, Vaccines, CHC and General Medicines performance. In Japan, third-quarter sales increased 13.3% to €423 million reflecting the strong performance of Dupixent® and Sarclisa®. In Rest of World first-nine months sales increased 5.0% mainly supported by growth of Dupixent®, Oncology, General Medicines and CHC.

R&D update at the end of the third quarter 2021

Regulatory update

  • The U.S. Food and Drug Administration (FDA) approved Nexviazyme® (avalglucosidase alfa) for the treatment of patients one year of age and older with late-onset Pompe disease. Nexviazyme® was also approved in Japan. Nexviazyme® is a long-term enzyme replacement therapy targeting the mannose-6-phosphate receptor, the key pathway for cellular uptake of enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells. The approval was based on the Phase 3 COMET study, showing clinically meaningful improvements in respiratory function and movement endurance measures in people with late-onset Pompe disease.
  • The European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Nexviazyme® (avalglucosidase alfa), for the treatment of Pompe disease. However, they considered that avalglucosidase alfa does not qualify as a New Active Substance (NAS), leading Sanofi to be requesting a re-examination of the CHMP opinion in relation to the NAS conclusion.
  • The FDA accepted the resubmission of the Biologics License Application (BLA) for sutimlimab, its investigational therapy for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). The FDA is reviewing the BLA under priority review with a PDUFA action date of February 5, 2022. Sutimlimab has previously received Breakthrough Therapy Designation (BTD) and Orphan Drug Designations (ODD) from the FDA.
  • Olipudase alfa, an investigational recombinant human acid sphingomyelinase for the treatment of Acid Sphingomyelinase Deficiency (ASMD), was submitted in Japan on September 30th, through the Sakigake regulatory pathway.
  • The FDA accepted for priority review of the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab) to treat patients in 2L with recurrent or metastatic cervical cancer.
  • The FDA approved fexinidazole, the first 10-day once-a-day oral treatment for Trypanosoma brucei gambiense sleeping sickness, in patients 6 years of age and older and weighing at least 20 kg. Both first stage and second stage of the disease are targeted, in which the parasites have crossed the blood-brain barrier, causing patients to suffer from neuropsychiatric symptoms.
  • The China National Medical Products Administrations (NMPA) approved the use of Dupixent® (dupilumab), for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
  • The FDA granted Fast-Track Designation for SAR443820, a RIPK1 inhibitor currently in Phase 1, for the amyotrophic lateral sclerosis (ALS) indication.
  • The FDA granted ODD for SAR445088 (formerly known as BIVV020), a complement C1s inhibitor currently in Phase 2, for the treatment of Chronic inflammatory demyelinating polyneuropathy (CIDP).

Portfolio update

Phase 3:

  • Dupixent® met its primary and all key secondary endpoints in Study A (the first of two trials) of the pivotal LIBERTY CUPID clinical program, showing a nearly doubled reduction in itch and urticaria activity scores, compared to antihistamines (standard-of-care treatment), in patients with moderate-to-severe chronic spontaneous urticaria (CSU). Study B of the clinical trial evaluates Dupixent® in adults and adolescents who remain symptomatic despite standard-of-care treatment and are intolerant or incomplete responders to an anti-IgE therapeutic (omalizumab). This study is expected to read out in H1 2022. CSU is an inflammatory skin disease, affecting more than 300,000 patients in the U.S. alone.
  • The pivotal trial evaluating Dupixent® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, met its primary and all secondary endpoints. The data show adding Dupixent® to standard of care topical corticosteroids (TCS) significantly reduced the overall disease severity and improved the skin clearance, itch and health-related quality of life measures at 16 weeks compared to TCS alone.
  • Detailed data from the MELODY study for nirsevimab to prevent respiratory illness caused by RSV (Respiratory Syncytial Virus) in infants was presented at the IDWeek congress showing a 74.5% reduction in medically attended LRTI (Lower Respiratory Tract Infections) after 5 months of follow up.
  • The study evaluating Libtayo® in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival primary endpoint, compared to chemotherapy alone, in first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels. Results were presented at the 2021 European Society of Oncology (ESMO) congress.
  • The PEGASUS phase 3 trial, evaluating rilzabrutinib, a BTK inhibitor for the treatment of pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints. The proportion of patients meeting the primary endpoint on Rilzabrutinib, was not significantly different from placebo. Rilzabrutinib continues to be investigated in a Phase 3 trial for the treatment of immune thrombocytopenia, a rare blood disorder, and in a Phase 2 study for the autoimmune condition IgG4-related disease. Additional Phase 2 studies in immunological and rare blood disorders diseases including asthma, atopic dermatitis, chronic spontaneous urticaria and warm autoimmune hemolytic anemia are planned to start in 2021.
  • A potential filing date for fitusiran, a small interference RNA therapy in development for the treatment of people with hemophilia A or B, with or without inhibitors, has been moved to 2024 due the introduction of a lower dose cohort in the ongoing phase 3 studies. The lower dose may be available to those patients currently on 50 mg every other month with anti-thrombin levels below the lower threshold of 15% and may enable them to continue to receive prophylactic treatment with fitusiran.
  • A new phase 3 study evaluating the safety profile of Nexviazyme® in infantile-onset Pompe Disease was initiated in children from 6 months to 17 years.
  • Patient enrollment is ongoing in EU and ROW in the phase 3 multicenter, open-label ELIKIDS study of Cerdelga® in pediatric patients with Gaucher Disease Type 1 and Type 3, under the pediatric investigation plan (PIP) as part of the overall clinical development plan. Submission is currently planned for 2025. Given the integral nature of the project it is not detailed anymore on the overall Sanofi pipeline chart.
  • MenQuadfi®, a quadrivalent ACWY vaccine, met all primary and secondary endpoints, demonstrating the induced superior immune responses to serogroup C based on geometric mean antibody titers (GMTs) compared to NeisVac-C (monovalent C vaccine) - standard-of-care vaccine- , in healthy toddlers. The data also showed superior immune responses to serogroup C based on seroprotection rates and GMTs compared to Nimenrix® (quadrivalent ACWY vaccine) in this population. MenQuadfi is approved in Europe for use as a single dose in individuals 12 months of age and older for the prevention of invasive meningococcal ACWY disease. In the US it is licensed for the prevention of invasive meningococcal disease in individuals 2 years of age and older.

Phase 2

  • Positive results from a Phase 2a study evaluating the safety and efficacy of amlitelimab in patients with moderate-to-severe atopic dermatitis, were presented as a late-breaker at the European Academy of Dermatology and Venerology (EADV) 2021 Virtual Congress. Amlitelimab, formerly known as KY1005, is a human monoclonal antibody targeting immune system regulator OX40-Ligand At week 16, the data demonstrated that when dosed intravenously every four weeks an 80% improvement in average EASI from baseline for the low dose and a 70% improvement in average EASI from baseline for the high dose was achieved, compared to 49% for the placebo group indicating a consistent pharmacological effect of blocking OX40-L. A Phase 2b dose ranging study is about to start, including lower doses and subcutaneous injection.
  • SAR444727 (formerly known as PRN473), a topically administered BTK inhibitor, entered Phase 2a study, evaluating safety, tolerability, and pharmacokinetics in patients with mild-to-moderate atopic dermatitis.
  • Data of tolebrutinib, an oral brain penetrant BTK inhibitor, were published in Lancet Neurology. The Phase 2b trial showed both safety and efficacy in relapsing multiple sclerosis. The treatment led to a dose-dependent reduction in new gadolinium-enhancing lesions, leading to a reduction of acute inflammation, while the drug was well tolerated. The phase 3 clinical trials in patients with relapsing and progressive forms of multiple sclerosis are currently enrolling.
  • SAR444245 (formerly known as THOR707), a novel non-alpha IL-2, entered a phase 2 basket trial in combination with Libtayo® for the treatment of various advanced skin cancers.
  • A phase 2 study cohort evaluating safety and efficacy of Sarclisa® in combination with atezolizumab in 1L mCRC was terminated.
  • A phase 2 study evaluating the safety and efficacy of Sarclisa®, in Adults with Warm Autoimmune Hemolytic Anemia (wAIHA) was initiated.
  • The phase 1/2 study of SP0254, an mRNA-based COVID-19 vaccine candidate, delivered positive interim results confirming the company’s platform robust capabilities and strategy in mRNA. Taking into account public health needs and given sufficient mRNA COVID-19 vaccines supply can be expected going forward, the development of SP0254 will not be further continued.

Phase 1

  • SAR443216, an anti-CD3xCD28xHER2 trispecific antibody, entered phase 1 study for the treatment of metastatic gastric cancers with HER2 low expression or HER2 mutation.
  • SAR443726, a novel IL13/OX40L nanobody entered a first-in-human, three-part, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult participants and in adult participants with moderate-to-severe atopic dermatitis.
  • Sangamo and Sanofi are continuing to advance the zinc finger genome editing program (SAR445136, formerly known as BIVV003) for sickle cell disease. The companies recently obtained manufacturing requirements guidance from FDA in preparation for further clinical studies and expect to share preliminary data from the sickle cell program at an upcoming meeting. The parties agreed to terminate the program addressing transfusion-dependent β-thalassemia (ST400) while focusing resources on the sickle cell disease indication.


  • On September 14, Sanofi completed the acquisition of Translate Bio, acquiring all of their outstanding shares for $38.00 per share in cash, representing a total equity value of approximately $3.2 billion. Translate Bio is a clinical-stage mRNA therapeutics company, having already signed a collaboration with Sanofi in 2018, to develop mRNA vaccines which was further expanded in 2020 to broadly address current and future infectious diseases. The acquisition builds on Sanofi’s establishment of a first-of-its kind vaccines mRNA Center of Excellence.
  • On September 8, Sanofi entered into a definitive agreement to acquire Kadmon Holdings4 for $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion. The acquisition supports Sanofi’s strategy to continue to grow its General Medicines core assets and will immediately add Rezurock™(belumosudil) to its transplant portfolio. This latter, a Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, has been recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.

An update of the R&D pipeline as of September 30, 2021, is available on our website.

Progress on implementation of the Corporate Social Responsibility strategy

Sanofi is accelerating its efforts to address climate change and intends to achieve net zero5 greenhouse gas (GHG) emissions across all operations (scope 1 & 2) and the entire value chain (scope 3) by 2050. In alignment with the 1.5°C pathway, this new commitment will be building on years of work to reduce the environmental footprint of its products and activities through its Planet Mobilization program.

In this journey, the company has also set an interim target to reach by 2030 carbon neutrality6 across all scopes of emissions, 20 years ahead of its previous commitment made in 2015 after the COP21 and the Paris Agreement.

Sanofi’s carbon footprint (scope 1 and 2) has decreased by –27% between 2015 and 2020. As per today, renewable electricity represents 50% of total electricity consumption, on track to reach 100% of renewable electricity supply in 2030, and its RE1007 commitment.

As a result of an eco-driving policy and the renewal of the car fleet, the eco fleet represents 22% of total car fleet today with the objective to reach 100% by 2030.

The company will continue to report on progress annually to ensure its efforts are on track.

Finally, in the run-up to the 26th UN Climate Change Conference of the Parties (COP26), Sanofi has joined the UN’s 'Race to Zero' initiative. This global campaign mobilizes cities, regions, investors and 20% of the major companies by revenue committing to net zero carbon emissions by 2050. The COP26 will take place in Glasgow (UK) from October 31 until November 12, 2021.

In recognition of Sanofi’ ESG strategy implementation, Sanofi is ranked #1 in the European pharmaceutical sector in the latest international ESG ranking issued by Vigeo Eiris (V.E), published late August 2021. V.E, which is part of Moody’s ESG Solutions, is an independent international ESG rating agency. Its assessment is based on information covering 28 areas of interest ranging from climate change, health, safety, and environmental issues to human and labor rights.

VE's ESG scores measure the degree to which companies factor and manage material Environmental, Social and Governance factors. Across the pharmaceutical sector globally, Sanofi scored of 62/100 points moving up from its fourth place in the ranking one year ago.

Embedded in Sanofi's long-term Play to Win strategy, the company’s ESG strategy is based on four essential pillars.

Sanofi Global Health, a newly formed nonprofit unit within the company, will provide thirty of Sanofi's medicines across a wide range of therapeutic areas to patients in 40 of the lowest income countries. Sanofi Global Health will also fund the training of healthcare professionals and the development of sustainable care systems.

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