07.16.21
Headquarters: Paris, France
twitter.com/sanofi
www.sanofi.com
Headcount: 100,409
Year Established: 2004
Pharma Revenues: $38,870 (0%)
Net Income: $15,169 (>100%)
R&D: $6,791 (0%)
TOP SELLING DRUGS
This past year Sanofi invested in bolstering its assets in immunology and oncology via acquisitions of Tidal Therapeutics, Kymab Group, and Principia Biopharma, and invested €1.6 billion in vaccine production sites in Singapore, France, and Canada.
While revenues remained relatively flat, the continuous uptake and potential of top seller Dupixent, a specialty biologic used to treat eczema and asthma, more than offset declines in diabetes and cardiovascular franchises (namely Plavix and Lantus). Sanofi also met several key regulatory milestones, including recent progress with its COVID-19 vaccine candidate being developed with GlaxoSmithKline.
Sanofi also launched EUROAPI, which according to estimates, is expected to be the largest API player in the EU, ranking number 1 in small molecules API, and number 2 on the global API market.
A note regarding financials. There was a change of presentation according to the Company new management reporting basis for 2020 in order to be reported under IFRS and its related interpretations for comparison purposes.
While Plavix sales dropped 25% in 2020, mainly reflecting lower sales in China, Dupixent sales reached $4.3 billion, with total prescriptions increasing 65% and new to brand prescriptions up 18% despite fewer in person physician visits, which remain below the pre COVID level. Full year 2020 Lovenox sales were up 9% driven by Rest of the World sales growth, which more than offset biosimilar competition in Europe.
Also, benefiting from increased demand, Influenza vaccine sales were up 43%, reflecting strong demand in the northern hemisphere. In Europe, sales growth was driven by increased vaccination coverage and the launch of the differentiated portfolio (Efluelda, a quadrivalent Influenza Vaccine High Dose and Supemtek, a recombinant influenza vaccine).
Acquisitions
Three acquisitions in 2020 added assets in key areas of oncology, immunology, autoimmune, and allergy. For $160 million upfront and up to $310 million in potential milestones, Sanofi acquired Tidal Therapeutics, adding an innovative mRNA-based research platform with research capabilities in both immuno-oncology and inflammatory diseases, and potentially applicability to other disease areas as well. Ongoing preclinical programs include in vivo re-programming of T cells for cancer indications.
The acquisition of Kymab Group for approximately $1.1 billion upfront and up to $350 million for certain milestones, added KY1005, a fully human monoclonal antibody targeting key immune system regulator OX40L, and oncology asset KY1044, an ICOS agonist monoclonal antibody currently in early Phase1/2 development as monotherapy and in combination with an anti-PD-L1.
Lastly, Sanofi acquired Principia Biopharma for approximately $3.7 billion strengthening core R&D areas of autoimmune and allergic diseases. The acquisition provides full control of brain-penetrant BTK inhibitor SAR442168 in multiple sclerosis (MS), and allows expansion of the development program into other central nervous system diseases and therapeutic areas. Sanofi also gained the advanced oral Bruton’s tyrosine kinase inhibitor (BTK) rilzabrutinib with potential across a range of immunology and inflammation indications.
Corporate news
In January 2021, Sanofi unveiled EUROAPI as the name of what is to be the largest API player in the EU, with approximately €1 billion in expected sales by 2022. Representing “made in Europe” API state-of-the-art industrial capabilities and technologies, EUROAPI will help secure significant API manufacturing and supply capacities for Europe and beyond.
In line with its corporate strategy, Sanofi is investing €610 million to create a new production site and research center in France dedicated to vaccines. A vaccine production site in Neuville sur Saône and a new research center in Marcy-l'Etoile will both be dedicated to vaccines and the investment will strengthen Sanofi’s capacity to research innovative vaccines and produce them on a massive scale.
In Toronto, Sanofi is investing more than €600 million to build a new vaccine facility to increase supply of its differentiated influenza vaccines in Canada, the U.S. and Europe. The company’s Fluzone High-Dose Quadrivalent influenza vaccine has four times more antigen than standard-dose vaccine and is specifically designed to provide superior protection against influenza for older adults.
Also part of its efforts to strengthen its vaccines manufacturing capacities, Sanofi is investing €400 million over five years in a unique vaccine production site in Singapore leveraging cutting edge manufacturing and digital technologies. The new site will allow Sanofi to produce innovative vaccines on a massive scale for Asia, and quickly respond to future pandemic risks.
R&D
Several key oncology assets advanced this past year, including the FDA approval of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma. The Sarclisa regimen reduced risk of disease progression or death by 45% compared to standard of care in patients who had relapsed after one to three prior therapies. This is the second FDA approval for Sarclisa in combination with standard of care backbone therapies.
The FDA also approved Libtayo for first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%. Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials. This is the third approval for Libtayo in the U.S.
Additionally, Libtayo is now approved for advanced stages of the two most common skin cancers in the U.S., advanced basal cell carcinoma and metastatic BCC. Furthmore, a Phase 3 trial of Libtayo in advanced cervical cancer was stopped early for positive results on overall survival. Libtayo is the first immunotherapy to demonstrate improved survival in cervical cancer, reducing the risk of death by 31% compared to chemotherapy. Regulatory submissions are planned in 2021.
FDA granted priority review for avalglucosidase alfa, a potential new therapy for Pompe disease, with a decision expected soon. Regulatory submission was based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, a rare degenerative muscle disorder that affects approximately 3,500 people in the U.S.
Also of note, pivotal data show Dupixent significantly reduced asthma attacks and improved lung function in children. Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma in a Phase 3 trial, with potential to be best-in-class treatment for these patients. The FDA’s decision is expected by October 2021.
COVID vaccine supply
In addition to leveraging its manufacturing capacity to support Moderna, Johnson & Johnson, and BioNTech with the manufacture of their respective COVID vaccines, Sanofi and GSK recently initiated a global Phase 3 trial of the companies adjuvanted recombinant-protein COVID-19 vaccine candidate. A two-stage design will evaluate vaccine formulations targeting original D.614 virus as well as B.1.351 variant, in diverse geographies with multiple circulating variants. A booster study program will complement the Phase 3 trial. Pending positive outcomes and regulatory reviews, the vaccine could be approved in 4Q21. Encouraging interim results from the Phase 2 study showed the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response.
Meanwhile, Sanofi is the only company to leverage its manufacturing capacity and expertise to support three different COVID-19 vaccines to help address global supply demands. Sanofi will manufacture up to 200 million doses of Moderna’s vaccine in the U.S. starting in September 2021 leveraging its infrastructure and manufacturing at its site in Ridgefield, NJ, to perform fill and finish.
For J&J, Sanofi will provide several manufacturing steps from its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of Janssen’s COVID-19 vaccine candidate in 2021, at a rate of approximately 12 million doses per month. And, from summer 2021, Sanofi will perform late-stage manufacturing to supply over 125 million doses of BioNTech’s COVID-19 vaccine for the EU from its production facilities in Frankfurt.
twitter.com/sanofi
www.sanofi.com
Headcount: 100,409
Year Established: 2004
Pharma Revenues: $38,870 (0%)
Net Income: $15,169 (>100%)
R&D: $6,791 (0%)
TOP SELLING DRUGS
| Drug | Indication | 2020 Sales | (+/-%) |
| Dupixent | eczema/dermatitis | $4,341 | 87% |
| Lantus | diabetes | $3,268 | -3% |
| Influenza Vaccines | vaccines | $3,036 | 43% |
| Pentacel | vaccines | $2,587 | 19% |
| Aubagio | relapsing-Remitting MS (RRMS) | $2,512 | 19% |
| Lovenox | thrombosis | $1,659 | 9% |
| Myozyme / Lumizyme | Pompe disease | $1,164 | 13% |
| Toujeo | diabetes | $1,146 | 16% |
| Plavix | heart attack, stroke | $1,125 | -25% |
| Fabrazyme | Fabry disease | $1,003 | 10% |
This past year Sanofi invested in bolstering its assets in immunology and oncology via acquisitions of Tidal Therapeutics, Kymab Group, and Principia Biopharma, and invested €1.6 billion in vaccine production sites in Singapore, France, and Canada.
While revenues remained relatively flat, the continuous uptake and potential of top seller Dupixent, a specialty biologic used to treat eczema and asthma, more than offset declines in diabetes and cardiovascular franchises (namely Plavix and Lantus). Sanofi also met several key regulatory milestones, including recent progress with its COVID-19 vaccine candidate being developed with GlaxoSmithKline.
Sanofi also launched EUROAPI, which according to estimates, is expected to be the largest API player in the EU, ranking number 1 in small molecules API, and number 2 on the global API market.
A note regarding financials. There was a change of presentation according to the Company new management reporting basis for 2020 in order to be reported under IFRS and its related interpretations for comparison purposes.
While Plavix sales dropped 25% in 2020, mainly reflecting lower sales in China, Dupixent sales reached $4.3 billion, with total prescriptions increasing 65% and new to brand prescriptions up 18% despite fewer in person physician visits, which remain below the pre COVID level. Full year 2020 Lovenox sales were up 9% driven by Rest of the World sales growth, which more than offset biosimilar competition in Europe.
Also, benefiting from increased demand, Influenza vaccine sales were up 43%, reflecting strong demand in the northern hemisphere. In Europe, sales growth was driven by increased vaccination coverage and the launch of the differentiated portfolio (Efluelda, a quadrivalent Influenza Vaccine High Dose and Supemtek, a recombinant influenza vaccine).
Acquisitions
Three acquisitions in 2020 added assets in key areas of oncology, immunology, autoimmune, and allergy. For $160 million upfront and up to $310 million in potential milestones, Sanofi acquired Tidal Therapeutics, adding an innovative mRNA-based research platform with research capabilities in both immuno-oncology and inflammatory diseases, and potentially applicability to other disease areas as well. Ongoing preclinical programs include in vivo re-programming of T cells for cancer indications.
The acquisition of Kymab Group for approximately $1.1 billion upfront and up to $350 million for certain milestones, added KY1005, a fully human monoclonal antibody targeting key immune system regulator OX40L, and oncology asset KY1044, an ICOS agonist monoclonal antibody currently in early Phase1/2 development as monotherapy and in combination with an anti-PD-L1.
Lastly, Sanofi acquired Principia Biopharma for approximately $3.7 billion strengthening core R&D areas of autoimmune and allergic diseases. The acquisition provides full control of brain-penetrant BTK inhibitor SAR442168 in multiple sclerosis (MS), and allows expansion of the development program into other central nervous system diseases and therapeutic areas. Sanofi also gained the advanced oral Bruton’s tyrosine kinase inhibitor (BTK) rilzabrutinib with potential across a range of immunology and inflammation indications.
Corporate news
In January 2021, Sanofi unveiled EUROAPI as the name of what is to be the largest API player in the EU, with approximately €1 billion in expected sales by 2022. Representing “made in Europe” API state-of-the-art industrial capabilities and technologies, EUROAPI will help secure significant API manufacturing and supply capacities for Europe and beyond.
In line with its corporate strategy, Sanofi is investing €610 million to create a new production site and research center in France dedicated to vaccines. A vaccine production site in Neuville sur Saône and a new research center in Marcy-l'Etoile will both be dedicated to vaccines and the investment will strengthen Sanofi’s capacity to research innovative vaccines and produce them on a massive scale.
In Toronto, Sanofi is investing more than €600 million to build a new vaccine facility to increase supply of its differentiated influenza vaccines in Canada, the U.S. and Europe. The company’s Fluzone High-Dose Quadrivalent influenza vaccine has four times more antigen than standard-dose vaccine and is specifically designed to provide superior protection against influenza for older adults.
Also part of its efforts to strengthen its vaccines manufacturing capacities, Sanofi is investing €400 million over five years in a unique vaccine production site in Singapore leveraging cutting edge manufacturing and digital technologies. The new site will allow Sanofi to produce innovative vaccines on a massive scale for Asia, and quickly respond to future pandemic risks.
R&D
Several key oncology assets advanced this past year, including the FDA approval of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma. The Sarclisa regimen reduced risk of disease progression or death by 45% compared to standard of care in patients who had relapsed after one to three prior therapies. This is the second FDA approval for Sarclisa in combination with standard of care backbone therapies.
The FDA also approved Libtayo for first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%. Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials. This is the third approval for Libtayo in the U.S.
Additionally, Libtayo is now approved for advanced stages of the two most common skin cancers in the U.S., advanced basal cell carcinoma and metastatic BCC. Furthmore, a Phase 3 trial of Libtayo in advanced cervical cancer was stopped early for positive results on overall survival. Libtayo is the first immunotherapy to demonstrate improved survival in cervical cancer, reducing the risk of death by 31% compared to chemotherapy. Regulatory submissions are planned in 2021.
FDA granted priority review for avalglucosidase alfa, a potential new therapy for Pompe disease, with a decision expected soon. Regulatory submission was based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, a rare degenerative muscle disorder that affects approximately 3,500 people in the U.S.
Also of note, pivotal data show Dupixent significantly reduced asthma attacks and improved lung function in children. Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma in a Phase 3 trial, with potential to be best-in-class treatment for these patients. The FDA’s decision is expected by October 2021.
COVID vaccine supply
In addition to leveraging its manufacturing capacity to support Moderna, Johnson & Johnson, and BioNTech with the manufacture of their respective COVID vaccines, Sanofi and GSK recently initiated a global Phase 3 trial of the companies adjuvanted recombinant-protein COVID-19 vaccine candidate. A two-stage design will evaluate vaccine formulations targeting original D.614 virus as well as B.1.351 variant, in diverse geographies with multiple circulating variants. A booster study program will complement the Phase 3 trial. Pending positive outcomes and regulatory reviews, the vaccine could be approved in 4Q21. Encouraging interim results from the Phase 2 study showed the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response.
Meanwhile, Sanofi is the only company to leverage its manufacturing capacity and expertise to support three different COVID-19 vaccines to help address global supply demands. Sanofi will manufacture up to 200 million doses of Moderna’s vaccine in the U.S. starting in September 2021 leveraging its infrastructure and manufacturing at its site in Ridgefield, NJ, to perform fill and finish.
For J&J, Sanofi will provide several manufacturing steps from its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of Janssen’s COVID-19 vaccine candidate in 2021, at a rate of approximately 12 million doses per month. And, from summer 2021, Sanofi will perform late-stage manufacturing to supply over 125 million doses of BioNTech’s COVID-19 vaccine for the EU from its production facilities in Frankfurt.
