On October 28, 2021 Sanofi reported that Q3 2021 sales grew double digit to €10.4 billion (up 10.1%) due to strong growth from Dupixent, Vaccines and CHC (Press release, Sanofi, OCT 28, 2021, View Source [SID1234592100])
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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."
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 net sales by Global Business Unit (variation at CER; € million; % of total sales)
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
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%.
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.
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.
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.
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).
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
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).
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).
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
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) (Free ESMO Whitepaper) 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.
Acquisitions
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.
Sanofi continues its efforts to fight polio and sleeping sickness, two of its historical programs that address global health issues. Sanofi is the only pharmaceutical company that keeps developing and supplying treatments for sleeping sickness. It has committed itself alongside the WHO to eliminate this neglected tropical disease in humans by 2030. Over the years, Sanofi has supplied billions of polio vaccine doses, including hundreds of millions of donated doses to support the global polio eradication effort.
To contribute to better resource conservation, Sanofi plans to remove all pre-formed plastic packaging (blister packs) for its vaccines by 2027. In addition, the company is committed to ecodesigning all its new products by 2025. To reduce its greenhouse gas emissions by 55% by 2030, all Sanofi sites will use 100% renewable electricity and the company has set a target of a carbon-neutral car fleet, both by 2030.
As a global company, Sanofi is committed to ensuring that its leaders reflect the communities and patients it serves. The company is committed to continue fostering an organization where all employees have equal opportunities to reach positions of responsibility within the company.
Sanofi also keeps its commitment to making a strong contribution to current global public health priorities, with the supply of half a billion doses of authorized vaccines. Sanofi is the only company leveraging its worldwide manufacturing capacity and expertise for the supply of three different authorized COVID-19 vaccines from BioNTech / Pfizer, Moderna, and Johnson & Johnson. Manufacturing teams on three industrial sites of the company in France, Germany and the U.S. are mobilized, with 30 million doses released by end September.
At the same time, Sanofi continues its efforts in the fight against the COVID-19 pandemic with its adjuvanted recombinant protein candidate vaccine, developed in partnership with GSK. In parallel to its ongoing Phase 3 efficacy and safety study, Sanofi has expanded its development program to include a study of the vaccine as a potentially broadly protective booster to address evolving public health needs. First data readout is expected before year-end.
2021 third-quarter and the first nine months financial results
Business Net Income8
In the third quarter of 2021, Sanofi generated net sales of €10,432 million, an increase of 10.1% (on a reported basis and at CER). In the first nine months, net sales were €27,767 million up 4.2% (up 8.2% at CER).
Third-quarter other revenues decreased 0.7% (up 0.2% at CER) to €397 million, reflecting decreased VaxServe sales of non-Sanofi products (€336 million, down 5.3% at CER). In the first nine months, other revenues increased 2.0% (up 8.1% at CER) to €993 million, including higher VaxServe sales of non-Sanofi products (€790 million, up 0.8% at CER).
Third-quarter Gross Profit increased 13.0% (on a reported basis and at CER) to €7,591 million. The gross margin ratio increased 1.9 percentage points to 72.8% versus the third quarter of 2020. This improvement mainly reflected efficiency gains in Industrial Affairs, favorable impact of growing weight of Specialty Care (the Pharmaceuticals gross margin ratio improved from 73.5% to 75.2%), positive product mix of Vaccines (Vaccines gross margin ratio increased 3.7 percentage point to 72.0% which more than offset lower CHC gross margin ratio (64.7% versus 66.6%). In the first nine months, the gross margin ratio increased 0.9 percentage point to 72.0% (72.1% at CER).
Research and Development (R&D) expenses increased 9.2% (up 9.3% at CER) to €1,443 million in the third quarter, reflecting increase in priority assets development and early pipeline as well as recent acquisitions partly offset by efficiencies. In the first nine months, R&D expenses increased 2.3% to €4,106 million and were up 4.9% at CER as increased investment behind key assets were partly offset by the benefits of terminating diabetes and cardiovascular care related projects recorded in 2020.
Third-quarter selling general and administrative expenses (SG&A) increased 3.9% to €2,267 million. At CER, SG&A expenses were up 3.6%, reflecting increased commercial investments in Specialty Care growth drivers which were partially offset by continued streamlining of General and Administrative expenses (G&A). In the third quarter, the ratio of SG&A to sales decreased 1.3 percentage points to 21.7% compared to the prior year. In the first nine months, SG&A expenses increased 0.1% to €6,797 million (up 3.6% at CER). In the first nine months, ratio of SG&A to sales was 1.0 percentage point lower at 24.5% compared to the prior year.
Third-quarter operating expenses were €3,710 million, an increase of 5.9% and 5.7% at CER. In the first nine months operating expenses were €10,903 million, an increase of 0.9% and an increase of 4.1% at CER.
Third-quarter other current operating income net of expenses was -€289 million versus -€182 million in the third quarter of 2020. Other current operating income net of expenses included an expense of €399 million (versus an expense of €229 million in the third quarter of 2020) corresponding to the share of profit to Regeneron of the monoclonal antibodies Alliance, reimbursement of development costs by Regeneron and the reimbursement of commercialization-related expenses incurred by Regeneron. In the first nine months, other current operating income net of expenses was -€589 million versus -€437 million in the same period of 2020.
The share of profit from associates was -€5 million versus €1 million in Q3 2020 and included the share of U.S profit related to VaxelisTM.
Third-quarter business operating income8 (BOI) increased 17.5% to €3,558 million. At CER, BOI increased 17.3%. The ratio of BOI to net sales was 34.1% versus 31.9% in Q3 2020 reflecting seasonal contribution of flu vaccines, gross margin ratio improvement as well as SG&A ratio improvement. In the first nine months, business operating income was €8,461 million, up 9.7% (up 15.0% at CER) and the ratio of business operating income to net sales increased 1.6 percentage points to 30.5% (30.8% at CER).
Net financial expenses were €85 million in the third quarter versus €76 million in the same period of 2020.
Third-quarter and the first-nine months 2021 effective tax rate was 21.0% versus 22% in the prior year. Sanofi expects its effective tax rate to be around 21% in 2021, everything being equal in the U.S.
Third-quarter business net income8 increased 19.0% to €2,736 million and increased 18.8% at CER. The ratio of business net income to net sales increased 1.9 percentages points to 26.2% versus the third quarter of 2020. In the first nine months, business net income increased 11.4% to €6,484 million and increased 16.9% at CER. The ratio of business net income to net sales increased 1.6 percentage points to 23.4% versus the same period of 2020.
In the third quarter of 2021, business earnings per share8 (EPS) was €2.18, up 19.1% on a reported basis (and at CER). The average number of shares outstanding was 1,254.5 million versus 1,255.7 million in third quarter 2020. In the first nine months of 2021, business earnings per share8 was €5.18, up 11.6% on a reported basis and up 17.2% at CER. The average number of shares outstanding was 1,251.7 million in the first nine months of 2021 versus 1,253.0 million in the first nine months 2020.
Reconciliation of IFRS net income reported to business net income (see Appendix 4)
In the first nine months of 2021, the IFRS net income was €5,093 million. The main items excluded from the business net income were:
An amortization charge of €1,160 million related to fair value remeasurement on intangible assets of acquired companies (primarily Genzyme: €380 million, Bioverativ: €238 million, Boehringer Ingelheim CHC business: €148 million and Ablynx: €126 million) and to acquired intangible assets (licenses/products: €70 million). These items have no cash impact on the Company.
An impairment of intangible assets of €177 million mainly related to sutimlimab (termination of ITP).
Restructuring costs and similar items of €494 million related to streamlining initiatives.
A €440 million tax effect arising from the items listed above, mainly comprising €320 million of deferred taxes generated by amortization and impairments of intangible assets and €121 million associated with restructuring costs and similar items (see Appendix 4).
Capital Allocation
In the first nine months of 2021, free cash flow before restructuring, acquisitions and disposals increased by 21.0% to €6,968 million, after net changes in working capital (+€218 million) and capital expenditures (-€953 million). After acquisitions9 (-€1,093 million of which Kiadis -€319 million, Tidal Therapeutics -€135 millions), proceeds from disposals9 (+€461 million), and payments related to restructuring and similar items (-€781 million), free cash flow10 increased 1.9% to €5,555 million, reflecting recent acquisitions to strengthen the long-term pipeline and less proceeds compared to last year as Seprafilm was divested in Q1 2020 (€311 million). After the acquisition of Translate Bio (-€ 2,397 million) and Kymab (-€922 million) and the dividend paid by Sanofi (-€4,008 million), net debt increased from €8,790 million at December 31, 2020 to €10,427 million at September 30, 2021 (amount net of €9,785 million cash and cash equivalents).