Strong 2021 sales and business EPS(1) growth enabling increased investment in R&D
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Strong 2021 sales and business EPS(1) growth enabling increased investment in R&D
Paris, February 4, 2022 Q4 2021 sales growth of 4.1% and business EPS(1) growth of 9.8% at CER
Full-year 2021 delivered 7.1% sales growth and 15.5% business EPS at CER
Progress on Corporate Social Responsibility strategy
Key milestone and regulatory achievements on R&D transformation
2022 financial outlook
Sanofi Chief Executive Officer, Paul Hudson, commented: “Sanofi has closed 2021 with a strong performance in the fourth quarter driven by high double-digit sales growth of Dupixent®, which continues to set impressive record sales quarter after quarter. This quarter marks the first time Specialty Care has led our GBUs by sales, highlighting a significant milestone in our transformation. At the same time, Vaccines delivered another year of record influenza sales and is on a clear growth path as demonstrated at our recent Vaccines Day. In R&D, we continue to be relentless in our commitment to expand our innovative pipeline. Last quarter, Sanofi achieved a new milestone, a first in recent years, by moving seven molecules into Phase 1 and seven pipeline programs into Phase 2 trials, showcasing our success in rapidly advancing potentially transformative medicines. We further strengthened our R&D capabilities with a series of value creating M&A transactions in 2021. Our excellent financial performance validates our ability to increase profitability through improved product mix, supported by expense management and the reinvestment of savings behind our growth drivers, all of which puts us on a trajectory to achieving our 2022 financial targets.“
Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9) (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 9). The consolidated income statement for Q4 2021 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) Free cash flow is a non-GAAP financial measure (definition in Appendix 9); (3) 2021 business EPS was €6.56; (4) 2020 IFRS net income reported reflected capital gain from sales of Regeneron shares in Q2 2020)
2021 fourth-quarter and full-year Sanofi sales ---------------------------- Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER1 ---------------------------- In the fourth quarter of 2021, Sanofi sales were €9,994 million, up 6.5% on a reported basis. Exchange rate movements had a positive effect of 2.4 percentage points, mainly due to the U.S. dollar. At CER, company sales were up 4.1%. In 2021 Sanofi sales reached €37,761 million, up 4.8% on a reported basis. Exchange rate movements had a negative effect of 2.3 percentage points. At CER, company sales were up 7.1%.
Global Business Units Fourth-quarter 2021 net sales by Global Business Unit (variation at CER; € million; % of total sales) Fourth-quarter 2021 net sales by geographic region (variation at CER; € million; % of total sales) Fourth-quarter 2021 operating income Fourth-quarter business operating income (BOI) increased 9.9% to €2,256 million. At CER, BOI increased 6.9%. The ratio of BOI to net sales increased 0.7 percentage points to 22.6% (22.5% at CER). In 2021, BOI increased 9.8% to €10,714 million. At CER, BOI increased 13.3%. The ratio of business operating income to net sales increased 1.3 percentage points to 28.4% (28.6% at CER).
Pharmaceuticals Fourth-quarter 2021 Pharmaceutical sales increased 7.4% to €6,919 million, mainly driven by the Specialty Care portfolio (up 21.3%) with continued strong performance of Dupixent® while sales in General Medicines decreased 3.8%. In 2021, Pharmaceuticals sales increased 7.6% to €26,970 million reflecting the strong performance of Specialty Care and General Medicines core assets. Specialty Care Dupixent
In the fourth quarter, Dupixent® (collaboration with Regeneron) sales increased 53.1% to €1,549 million. In the U.S., Dupixent® sales of €1,170 million (up 45.8%) 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 44% (year-over-year) and new-to-brand prescriptions (NBRx) grew 32% despite fewer in-person patient visits to HCP offices, which remain slightly below the pre-COVID level. In Europe, fourth-quarter Dupixent® sales grew 60.9% to €187 million reflecting continued growth in AD and additional launches in younger population in AD, asthma and CRSwNP. In Japan, part of the Rest of the world region, sales were €85 million (up 53.4%). In 2021, Dupixent® sales reached €5,249 million, (up 52.7%), of which €3.971 million were generated in the U.S. (up 46.2%). Each of the two regions Europe and the Rest of the World generated approximately 50% of the non-U.S. sales in the period. Neurology and Immunology
In the fourth quarter, Neurology and Immunology sales grew 3.1% to €588 million, reflecting strong Kevzara® sales which were partially offset by lower Aubagio® sales. In 2021, overall Neurology and Immunology sales remained stable. Aubagio® sales decreased 1.9% in the fourth quarter to €478 million due to lower sales in the U.S. reflecting increased competition partially offset by higher sales in Europe. Fourth-quarter Kevzara® (collaboration with Regeneron) sales increased 48.3% to €91 million due to an increase in global demand for IL-6 receptor blockers and the temporary tocilizumab shortage. Rare Disease
In the fourth quarter, Rare Disease sales increased 9.5% to €818 million driven by Pompe, Gaucher and Fabry franchises performance. In 2021, sales of Rare Disease increased 7.0% reflecting increased patient demand across the portfolio across all three geographic regions. The Pompe franchise reached more than €1 billion of sales in 2021. Fourth-quarter sales of the Pompe franchise (Myozyme/Lumizyme® + Nexviazyme®) increased 11.9% to €269 million primarily by new patient accruals across geographic regions. Myozyme®/Lumizyme® sales increase at 5.5% to €254 million. Sales of Nexviazyme® (which was launched in the US and Japan) were €15 million in the fourth quarter (€17 million in 2021). Sales of the Gaucher franchise (Cerezyme® + Cerdelga®) increased 12.8% (to €248 million) in the fourth quarter. Over the period, Cerezyme® sales increased 13.1% to €181 million, reflecting strong growth in the Rest of the World region. In Europe and the U.S., Cerezyme® sales were down 1.6% and 2.3%, respectively while Cerdelga® sales were up 11.9% globally driven by switches and new patient accruals in Europe and the U.S. Fourth-quarter Fabrazyme® sales increased 9.0% to €223 million driven by higher demand in Europe and the Rest of the World region and higher inventory in Europe. Oncology
Fourth-quarter and full-year 2021 sales of Oncology increased 10.3% (to €240 million) and 16.9%, respectively, driven by the Sarclisa® and Libtayo® launches which more than offset the impact of Jevtana® generic competition in Europe. Fourth-quarter Jevtana® sales decreased 16.8% to €110 million following the entry of generic competition in certain European markets (down 66.0%) at the end of March 2021. In the U.S., sales were up 13.3%, 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 have 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. Fourth-quarter Sarclisa® sales were €54 million (versus €25 million in the fourth quarter of 2020) driven by continued launch execution in Europe (€20 million), sales growth in the U.S. (€21 million) and in the Rest of the World region (€13 million) where sales performance was driven by the uptake in Japan. Libtayo® (collaboration with Regeneron) sales were €35 million (up 78.9%) in the fourth 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
In the fourth quarter, Rare Blood Disorders franchise sales decreased 10.4% (€292 million). Excluding industrial sales to Sobi, fourth-quarter sales were up 2.7% mainly driven by Cablivi® and Alprolix®. Industrial sales (of Eloctate® and Alprolix®) to Sobi were significantly lower in 2021 than in 2020 due to a change in the supply agreement which resulted in unusually high industrial sales to Sobi in 2020. In 2021 sales of Rare Blood Disorders decreased 3.0% and were up 8.0.% when excluding industrial sales to Sobi. Eloctate® sales were €141 million in the fourth quarter, down 12.2%. Excluding industrial sales to Sobi, Eloctate sales were down 4.4% due to lower U.S. sales (-3.9%) mainly reflecting inventory fluctuation. Sales in the Rest of the World region were down 28.3% reflecting lower industrial sales to Sobi (which are recorded in this region). Fourth-quarter Alprolix® sales were down 16.0% to €113 million. Excluding industrial sales to Sobi, Alprolix® sales were up 6.3%. In the U.S. sales were up 5.1%. Sales in the Rest of the World were down 48.1% reflecting lower industrial sales to Sobi (which are recorded in this region). Cablivi® sales increased by 23.3% to €38 million in the fourth quarter driven by launches in Europe (up 50.0% to €19 million). In the U.S., sales of the product were stable at €19 million, with the COVID-19 environment impacting treatment initiations at the hospital level.
General Medicines Fourth quarter General Medicines sales decreased 3.8% to €3,432 million and 2.3% excluding portfolio streamlining and Praluent® U.S. sales. The growth of core assets2 (up 2.1% to €1,429 million and up 3.9% excluding Praluent® U.S. sales) was driven by Multaq®, Plavix® and RezurockTM (consolidated from November 9). The non-core assets sales decreased 7.6% (to €1,783 million) mainly reflecting lower Generics sales and portfolio streamlining (-1.4 ppt impact). In 2021, General Medicines sales were down 1.4% to €14,218 million and up 0.4% excluding portfolio streamlining and Praluent® U.S. sales. In 2021, sales of the core assets were €5,768 million up 5.6% (and up 7.6% excluding Praluent® U.S. sales), driven by double-digit growth of Lovenox®, Mozobil® and Thymoglobulin® as well as Toujeo® performance. Non-core assets sales were €7,642 million, down 6.2% reflecting portfolio streamlining (-1.8 ppt), as well as lower Lantus®, Aprovel®/Avapro® and Generics sales. Diabetes
In the fourth quarter, global Diabetes sales decreased 1.5% to €1,091 million, reflected lower sales in Europe (down 4.0%) and the Rest of the World (down 8.8%), partially offset by growth in the U.S. (up 10.4%). In 2021, Diabetes sales were down 0.8% mainly as a result of lower Lantus® sales partially offset by growth from Toujeo® and Soliqua®. Fourth-quarter Toujeo® sales increased 1.8% to €230 million due to growth in the U.S. and Europe, partially offset by lower sales in the Rest of the World reflecting price and inventory adjustment in anticipation of the Volume Based Procurement (VBP) for insulins in China which will be implemented in the first half of 2022. Sanofi has participated in the VBP tender for basal insulin analogues in China in November and was among the bidding winners in the group A with Lantus®/Toujeo® and then has secured a significant volumes of its long-acting insulins at the hospital level. In 2022, Sanofi expects that its glargine sales to decrease by around 30% in China, benefiting from high volumes at significantly lower prices. Toujeo®/Lantus® sales were €459 million in China in 2021. Lantus® sales were €583 million, down 2.9% in the fourth quarter, due to lower sales in Europe and China partially offset by growth in the U.S. In China, sales reflected price and inventory adjustment in anticipation of the insulin VBP. Fourth-quarter Soliqua® sales increased 13.0% to €54 million driven by growth in all three geographic regions. In the Rest of World region, Soliqua® sales grew 30.0% supported by new launches. Cardiovascular and Established Rx Products
*Excluding Auto generics In the fourth quarter, Cardiovascular and Established Rx Products sales decreased 4.5% to €2,121 million. The performance of certain core assets, including Plavix®, Praluent® and Multaq® and the addition of Rezurock® was more than offset by lower sales of Lovenox® and Generics as well as the impact of the divestments of non-core products. In 2021, Cardiovascular and Established Rx Products sales were down 1.8% (down 0.7% excluding Praluent® U.S. sales) impacted by lower Aprovel®/Avapro® and generics sales as well as the impact of the divestments which offset strong growth of several core assets. Fourth-quarter Lovenox® sales decreased 7.9% to €335 million, reflected high base of comparison in the fourth quarter of 2020 when WHO guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients came into effect. In addition, supply limitations and biosimilar competition in Europe (down 11.1%) affected the performance. Plavix® sales were up 7.5% in the fourth quarter to €222 million due to higher sales in the Rest of the World region (up 11.4%) driven by China (up 28.1% to €88 million) largely offsetting lower sales in Japan and Europe. Fourth-quarter Aprovel®/Avapro® sales were down 6.1% to €112 million. Fourth-quarter Praluent® sales decreased 15.9% to €55 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 35.9%) were driven by strong performance in Europe. In China, Praluent® is listed on the NDRL (National Reimbursement Drug List) as of January 2022. Multaq® fourth quarter sales grew 20.3% to €99 million, reflecting strong U.S. sales growth. Sales of RezurockTM, a 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, were consolidated as of November 9 (through the Kadmon acquisition) and generated €20 million since that date. Pharmaceuticals business operating income In the fourth quarter, business operating income (BOI) of Pharmaceuticals increased 16.4% to €2,091 million (up 12.5% at CER). The ratio of BOI to net sales increased by 1.7 percentage points to 30.2% (29.9% at CER), reflecting an improvement of the gross margin ratio. In 2021, business operating income of Pharmaceuticals increased 2.2% to €9,409 million (up 4.9% at CER). The ratio of BOI to net sales decreased by 1.0 percentage points to 34.9% (35.0% at CER) reflecting strong investments behind Dupixent® partly offset by an improvement in overall gross margin ratio.
Vaccines
. Fourth-quarter Vaccines sales decreased 6.5% to €1,964 million, mainly reflecting lower U.S influenza vaccines sales partially offset by successful Efluelda® expansion in Europe and Polio/Pertussis/Hib in the Rest of the World region. In 2021, Vaccines sales increased 6.8% supported by Meningitis, Influenza and PPH vaccines. In the fourth quarter, Polio/Pertussis/Hib (PPH) vaccines sales increased 7.7% to €543 million driven by Pentaxim® in China and Hexaxim® in Europe. In the U.S., Pentacel® sales decreased due to inventory fluctuation and progressive Vaxelis® ramp-up. Vaxelis® was launched in the U.S. in June 2021, in-market sales are not consolidated and the profits are shared equally between Sanofi and Merck. Influenza vaccines sales decreased 12.4% in the fourth quarter, reaching €1,093 million. In the U.S. fourth-quarter sales were down 48.3% reflecting lower influenza vaccination rates when compared to last year, which resulted from the prioritization of COVID-19 booster vaccinations at the pharmacy level, as well as record shipments in the third quarter of 2021. In the U.S, Fluzone®HD gained 3.5 points share despite market contracted by 17% in volume (Sources: IQVIA Claims Medical (as of 1/1/22); IQVIA Claims Retail (as of 1/2/22)). In Europe, Influenza vaccines sales increased 51.1% driven by the adoption of a preferential recommendation for Efluelda® for people above 60 years old in Germany. In the Rest of the World region, influenza sales increased 22.7%. On a full-year basis, 2021 marked another record year with Influenza vaccines sales up 5.9% to €2,628 million. Fourth-quarter Meningitis sales decreased 31.2% to €91 million, reflecting a high base of comparison in the U.S. in the fourth quarter of 2020, when sales benefited from catch-up vaccinations. Booster vaccines sales decreased 1.6% in the fourth quarter to €124 million, due to lower sales in the Rest of the World region partially offset by growth in Europe. Vaccination rates in this segment have not yet returned to pre-COVID levels. Fourth-quarter Travel and endemic vaccines sales increased 17.1%, reflecting a low base of comparison in the fourth quarter of 2020 due to the pandemic environment. Vaccines business operating income In the fourth quarter, business operating income (BOI) decreased 22.3% (down 23.9% at CER) to €653 million compared to the same period of last year. This reflects lower U.S. influenza vaccines sales and higher R&D expenses related to Translate Bio and the mRNA center of excellence. In the fourth quarter, BOI to net sales ratio was 33.2% (versus 40.8% in the fourth quarter of 2020). In 2021, BOI increased 11.7% (up 12.5% at CER) to €2,609 million benefiting from sales performance and efficiency gain as well as the payment from Daiichi Sankyo in the first quarter of 2021. BOI to net sales ratio increased 2.2 percentage points to 41.3% (41.2% at CER). Excluding the payment from Daiichi Sankyo, BOI to net sales ratio was 39.4% in 2021.
Consumer Healthcare
In the fourth quarter, Consumer Healthcare (CHC) sales increased 5.6% to €1,111 million driven by growth in the U.S. and Europe. This performance was driven by the Cough and Cold franchise, as well as the Pain Care category which benefited from COVID-19 vaccinations. In 2021 CHC sales increased 4.6% 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 (-0.8 ppt impact). In the U.S., fourth-quarter CHC sales increased 12.6% to €280 million driven by double-digit growth of Allergy, Pain Care, Personal Care and Digestive Wellness categories. In Europe, fourth-quarter CHC sales increased 7.5% to €345 million mainly reflecting growth of the Cough and Cold and Pain Care franchises which also benefited from COVID-19 vaccinations. In Rest of World, fourth-quarter CHC sales increased 0.8% to €486 million, supported by Cough and Cold and Digestive Wellness categories, partially offset by lower sales of Allergy, Pain Care and Physical Wellness categories. CHC business operating income In the fourth quarter, business operating income (BOI) of CHC decreased 2.0.% (-5.3% at CER) to €298 million. The ratio of BOI to net sales decreased 2.7 percentage point to 26.8% versus the prior year which included a capital gain related to divestments of non-strategic assets. In 2021, BOI of CHC increased 5.9% (up 10.2% at CER) to €1,493 million due to higher sales, a strict control of operational expenses and higher capital gains related to divestments of non-strategic assets. The ratio of BOI to net sales increased 1.3 percentage points to 33.4% (33.8% at CER).
Company sales by geographic region
Fourth-quarter sales in the U.S. increased 1.8% to €3,820 million supported by the strong performance of Dupixent® and double-digit growth of CHC, Diabetes and Oncology. In 2021, U.S. sales grew 10.3%, mainly reflecting Dupixent® and double-digit growth of CHC. In Europe sales increased 9.8% in the fourth quarter to €2,804 million mainly driven by Dupixent® performance as well as strong Vaccines growth. In 2021, European sales increased 6.6% due to the growth of Specialty Care products driven by Dupixent® as well as the strong performance of Vaccines. In Rest of World sales increased 2.3% to €3,370 million in the fourth quarter, reflecting the performance of Dupixent® and Vaccines which more than offset lower sales of General medicines. Sales in China increased 5.7% to €558 million mainly as a result of the growth of Dupixent®, Plavix® and Vaccines. In Japan, fourth-quarter sales increased 0.5% to €404 million driven by Dupixent® and Sarclisa® which more than offset lower sales of Established products. In Rest of World 2021 sales increased 4.4% mainly supported by growth of Specialty Care products driven by Dupixent® as well as Vaccines and CHC.
R&D update at the end of the fourth quarter 2021 Regulatory update
Portfolio update Phase 3:
Phase 2:
Phase 1:
Acquisitions and major collaborations
An update of the R&D pipeline at as of December 31, 2021, is available on our website: https://www.sanofi.com/en/science-and-innovation/research-and-development
Progress on implementation of the Corporate Social Responsibility strategy that is fully integrated in our Play to Win strategy Sanofi Global Health and Medtronic Labs to collaborate to expand access to healthcare in Low to Middle Income Countries Globally, Non-Communicable Diseases (NCDs) are responsible for 41 million yearly deaths, equivalent to 71% of all deaths. Of these, 37% are premature deaths affecting those between the ages of 30 and 69. NCDs disproportionately affect people in low- and middle-income countries, where more than 75% of global NCD deaths, and 85% of premature deaths, occur. Against this backdrop, Sanofi Global Health is launching a multi-country, multi-year partnership with Medtronic Labs to expand access to healthcare for underserved patients living with diabetes and hypertension. This partnership will leverage digital health and a community-based approach to improve disease awareness, diagnosis, and management of diabetes and hypertension. The first phase will focus on Tanzania and Sierra Leone where it aims to reach more than 75,000 beneficiaries in strong collaboration with health system partners. This partnership aims to build a replicable and sustainable approach to community-focused chronic disease management while contributing to strengthening health systems as they build towards Universal Health Coverage (UHC) and the Sustainable Development Goals (SDGs). Sanofi Global Health has teamed up with Medtronic Labs to address the pressing challenge of non-communicable diseases in LMICs3. Status on our renewed CSR ambition In 2020, in the context of defining our renewed CSR ambitions we reviewed and updated our portfolio of initiatives. Numbers shown for 2021 below serve as the baseline to highlight our ongoing progress in the implementation of Sanofi’s CSR strategy. Affordable access Sanofi Global Health, a nonprofit unit formed within the company in April 2021, aims to provide 30 of Sanofi's medicines across a wide range of therapeutic areas to patients in 40 of the lowest income countries. Beyond the products provided, Sanofi Global Health will also focus on integrated programs that ensure optimal care management over time for patients. Sanofi is also committed to helping 1,000 patients living with rare diseases who have no access to treatments and will donate 100,000 vials of medicine for their treatments each year. This continues Sanofi’s 30-year commitment to patients suffering from rare diseases, such as Fabry, Gaucher or Pompe diseases, for which access to treatment is often limited. Our third initiative on access is to develop a global access plan for all new products, making them available in selected relevant markets within two years of launch.
R&D for unmet needs Sanofi continues its efforts to fight polio and sleeping sickness, two of its legacy programs that address global health issues. Sanofi has been involved in the fight against polio from the beginning and continues to play a critical role in the delivery of polio vaccines. It has also committed itself alongside the WHO to eliminate sleeping sickness in humans by 2030. Part of Sanofi’s R&D ambition is to develop innovative medicines to eliminate cancer deaths in children.
Efficiency & sustainability 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 eco-designing all its new products by 2025. To reduce its greenhouse gas emissions by 55% by 2030, all Sanofi sites will use 100% electricity from renewable sources and the company has set a target of a carbon-neutral car fleet, both by 2030.
People 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. Our ambition is to have 40% of women in top executive roles and 50% of women in senior leaders roles by 2025. Sanofi is continuing its social and economic engagement in the communities it operates in. Finally, Sanofi is embedding its commitment to society in its leaders’ career development paths to strengthen the social impact of their decisions.
ESG ratings In recognition of Sanofi’ continued CSR strategy implementation, a few of Sanofi’s ESG rankings have been positively updated:
Covid Update Sanofi also keeps its commitment to making a strong contribution to current global public health priorities, with the supply of up to 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 100 million doses released by end December 2021. 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. Positive preliminary booster data have shown that neutralizing antibodies increased across all primary vaccines received (mRNA or adenovirus) for all age groups tested, with a good safety and tolerability profile. Phase 3 trial continues to accrue number of events needed for analysis as populations around the world are increasingly exposed to COVID-19 variants; results are expected in Q1 2022. Sanofi intends to file booster data with regulatory authorities following the Phase 3 results.
Fourth-quarter and full-year 2021 financial results Business Net Income4 In the fourth quarter of 2021, Sanofi generated net sales of €9,994 million, an increase of 6.5% (up 4.1% at CER). In 2021, net sales were €37,761 million up 4.8% (up 7.1% at CER). Fourth-quarter other revenues increased 18.9% (up 15.5% at CER) to €421 million, including decreased VaxServe sales of non-Sanofi products of €288 million (down -10.4 % at CER). In 2021, other revenues increased 6.5% (up 10.1% at CER) to €1,414 million, including VaxServe sales of non-Sanofi products of €1,078 million (down -2.2 % at CER). Fourth-quarter Gross Profit increased 10.3% (up 7.5% at CER) to €6,944 million. The gross margin ratio increased 2.4 percentage points to 69.5% versus the fourth quarter of 2020, reflecting strong improvement of the Pharmaceuticals gross margin ratio (which increased from 70.9% to 75.4%) driven by favorable impact of growing weight of Specialty Care and efficiency gains in Industrial Affairs. The Vaccines gross margin ratio decreased to 56.0% from 60.7%, reflecting lower sales of U.S. influenza vaccines and inventory destruction associated to this lower demand. CHC gross margin ratio was 62.5%, down 1.5 percentage points. In 2021, the gross margin ratio increased 1.2 percentage point to 71.3% (71.4% at CER) driven by Specialty Care and efficiency gains in industrial affairs. Research and Development (R&D) expenses increased 4.6% (up 2.8% at CER) to €1,585 million in the fourth quarter, reflecting increase in priority assets development as well as recent acquisitions partly offset by efficiencies. In 2021, R&D expenses increased 2.9% to €5,692 million and were up 4.3% at CER driven by increased investment behind key assets and additional R&D expenses from recent acquisitions which were partly offset by efficiency and the benefits of terminating diabetes and cardiovascular related projects recorded in 2020. Fourth-quarter selling general and administrative expenses (SG&A) increased 6.0% to €2,758 million. At CER, SG&A expenses were up 3.9%, 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 fourth quarter, the ratio of SG&A to sales decreased 0.1 percentage point to 27.6% compared to the prior year. In 2021, SG&A expenses increased 1.7% to €9,555 million (up 3.7% at CER). In 2021, ratio of SG&A to sales was 0.8 percentage point lower at 25.3% compared to 2020. Fourth-quarter operating expenses were €4,343 million, an increase of 5.5% and 3.5% at CER. In 2021 operating expenses were €15,247 million, an increase of 2.2% and an increase of 3.9% at CER. Fourth-quarter other current operating income net of expenses was -€356 million versus -€123 million in the fourth quarter of 2020. Other current operating income net of expenses included an expense of €444 million (versus an expense of €290 million in the fourth 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 fourth quarter, this line also included €61 million of net capital gains related to General medicines and CHC portfolio streamlining compared to €72 million in the same period of 2020. In 2021, other current operating income net of expenses was -€946 million versus -€561 million in 2020 and included €318 million of net capital gains related to portfolio streamlining compared to €211 million in 2020. The full-year 2021 expense associated with the monoclonal antibodies Alliance with Regeneron was €1,429 million, which compared with an expense of €1,001 million in 2020 (see appendix 7 for further details). The share of profit from associates was €18 million versus €4 million in Q4 2020 and included the share of U.S profit related to VaxelisTM. Fourth-quarter business operating income4 (BOI) increased 9.9% to €2,256 million. At CER, BOI increased 6.9%. The ratio of BOI to net sales increased 0.7 percentage points to 22.6% mainly reflecting gross margin ratio improvement. In 2021, business operating income was €10,714 million, up 9.8% (up 13.3% at CER). In 2021, €730 million of savings were generated and fully reinvested in growth drivers and key programs in R&D. In 2021 the ratio of business operating income to net sales increased 1.3 percentage points to 28.4% (28.6% at CER). Net financial expenses were €83 million and €328 million in the fourth quarter and full-year 2021 (versus €93 million and 335 million in the same periods of 2020). Fourth-quarter and full-year 2021 effective tax rate was 20.5% and 20.9% versus 22% in the prior year. Sanofi expects its effective tax rate to be around 19% in 2022. Fourth-quarter business net income4 increased 13.3% to €1,730 million and increased 10.2% at CER. The ratio of business net income to net sales increased 1.0 percentage points to 17.3% versus the fourth quarter of 2020. In 2021, business net income increased 11.8% to €8,213 million and increased 15.5% at CER. The ratio of business net income to net sales increased 1.3 percentage points to 21.7% versus 2020. In the fourth quarter of 2021, business earnings per share4 (EPS) was €1.38, up 13.1% on a reported basis (up 9.8% at CER). The average number of shares outstanding was 1,254.9 million versus 1,255.1 million in fourth quarter 2020. In 2021, business earnings per share8 was €6.56, up 11.9% on a reported basis and up 15.5% at CER. The average number of shares outstanding was 1,252.5 million in 2021 versus 1,253.6 million in 2020.
Reconciliation of IFRS net income reported to business net income (see Appendix 4) In 2021, the IFRS net income was €6,223 million. The main items excluded from the business net income were:
Capital Allocation In 2021, free cash flow before restructuring, acquisitions and disposals increased by 32.6% to €9,977 million, after net changes in working capital (+€1,475 million) and capital expenditures (-€1,400 million). After acquisitions5 (-€1,488 million of which Kiadis -€326 million, Tidal Therapeutics -€135 million, Owkin -€160 million), proceeds from disposals5 (+€667 million) and payments related to restructuring and similar items (-€1,060 million), free cash flow6 increased 16.0% to €8,096 million. After the acquisition of Translate Bio (-€ 2,397 million), Kymab (-€932 million) and Kadmon (-€1,904 million), the dividend paid by Sanofi (-€4,008 million), net debt increased from €8,790 million at December 31, 2020 to €9,983 million at December 31, 2021 (amount net of €10,098 million cash and cash equivalents ----------- Financial statements are not audited. The audit procedures by the Statutory Auditors are underway. ----------- Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, risks related to Sanofi’s ability to complete the proposed transaction with Kadmon Holdings, Inc. on the proposed terms or on the proposed timeline, including the receipt of required regulatory approvals, the possibility that competing offers will be made, other risks associated with executing business combination transactions, as well as other risks related to Sanofi’s business, including the ability to grow sales and revenues from existing products and to develop, commercialize or market new products, competition, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Appendices
Media Relations Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com
Investor Relations Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | +1 908 981 5560 | priya.nanduri@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Appendix 1: 2021 fourth-quarter net sales by GBU, franchise, geographic region and product
Appendix 1: Full-year 2021 net sales by GBU, franchise, geographic region and product
Appendix 2: Business net income statement
** Determined on the basis of Business income before tax, associates, and non-controlling interests. *** Based on an average number of shares outstanding of 1,254.9 million in the fourth quarter of 2021 and 1,255.1 million in the fourth quarter of 2020. (1) Other includes the cost of global support functions (Finance, Human Resources, Information Solution & Technologies, Sanofi Business Services, etc…). (2) The 2020 items have been represented in order to take into account the reallocation of certain expenses, in particular the IT costs related to the new Digital organization, which were previously allocated to the Pharmaceuticals, Vaccines and Consumer Health Care segments and are now accounted for under "Other". It includes also the impacts of the IFRIC final agenda decision of April 2021 on the attribution of benefits to periods of service.
* Net of tax. ** Determined on the basis of Business income before tax, associates, and non-controlling interests. *** Based on an average number of shares outstanding of 1,252.5 million in the full year of 2021 and 1,253.6 million in the full year of 2020. (1) Other includes the cost of global support functions (Finance, Human Resources, Information Solution & Technologies, Sanofi Business Services, etc…). (2) The 2020 items have been represented in order to take into account the reallocation of certain expenses, in particular the IT costs related to the new Digital organization, which were previously allocated to the Pharmaceuticals, Vaccines and Consumer Health Care segments and are now accounted for under "Other". It includes also the impacts of the IFRIC final agenda decision of April 2021 on the attribution of benefits to periods of service.
Appendix 3: Consolidated income statements
(1) It Includes the impacts of the IFRIC final agenda decisions of March 2021 on the costs of configuring or customising application software used in a Software as a Service (SaaS) arrangement) and of April 2021 on the attribution of benefits to periods of service (2) In 2021 and 2020, mainly related to Sutimlimab impairments. (3) In 2020, includes mainly the gain on the sale of operations related to the Seprafilm product to Baxter. (4) In 2020, this line includes the pre-tax income from the sale of Regeneron shares following the public offer for sale and Regeneron's repurchase on May 29, 2020. This amount includes the gain related to the remeasurement at fair value of the 400,000 retained shares that could be used to finance the R&D collaboration under the letter of agreement dated 2018.
Appendix 4: Reconciliation of Net income attributable to equity holders of Sanofi to Business net income
(1) It Includes the impacts of the IFRIC final agenda decisions of March 2021 on the costs of configuring or customising application software used in a Software as a Service (SaaS) arrangement) and of April 2021 on the attribution of benefits to periods of service. (2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €394 million in the fourth quarter of 2021 and €370 million in the fourth quarter of 2020. (3) In 2021 and 2020, mainly related to Sutimlimab impairments. (4) In 2020, includes mainly the gain on the sale of operations related to the Seprafilm product to Baxter. (5) This line includes the result of the sale of 13 million of Regeneron’s shares as part of the public offering and of the 9.8 million of its shares repurchased by Regeneron. The amount does not include the gain related to the remeasurement at fair value at this date of the 400,000 retained shares. (6) Our non-GAAP indicator (Business Net Income) does not include the share of income related to equity accounting from Regeneron since it ceased to be an associate on May 29, 2020. As a result, this line reflects that exclusion up to this date. (7) Q4: Based on an average number of shares outstanding of of 1,254.9 million in the fourth quarter of 2021 and 1,255.1 million in the fourth quarter of 2020 FY : Based on an average number of shares outstanding of 1,252.5 million in the full year of 2021 and 1,253.6 million in the full year of 2020.
Appendix 5: Change in net debt
(1) Excluding any effect of equity method accounting for Regeneron investment for comparison purposes. (2) Includes the impacts of the IFRIC final agenda decisions of March 2021 on the costs of configuring or customising application software used in a Software as a Service (SaaS) arrangement and April 2021 on the attribution of benefits to periods of service. (3) Free cash flow includes investments and divestments not exceeding a cap of €500 million per transaction (inclusive of all payments related to the transaction). (4) Includes transactions that are above a cap of €500 million per transaction (inclusive of all payments related to the transaction).
Appendix 6: Simplified consolidated balance sheet
(1) Impacts of the IFRIC final agenda decisions of March 2021 on the costs of configuring or customising application software used in a Software as a Service (SaaS) arrangement and of April 2021 on the attribution of benefits to periods of service
Appendix 6: Simplified consolidated balance sheet 2020 reconciliation
(1) Impacts of the IFRIC final agenda decisions of March 2021 on the costs of configuring or customising application software used in a Software as a Service (SaaS) arrangement and of April 2021 on the attribution of benefits to periods of service
Appendix 7: Other current operating income net of expenses – Regeneron Alliances
Appendix 8: Currency sensitivity 2022 business EPS currency sensitivity
Currency exposure on Q4 2021 sales
Currency average rates
Appendix 9: Definitions of non-GAAP financial indicators Company sales at constant exchange rates (CER) When we refer to changes in our net sales “at constant exchange rates” (CER), this means that we exclude the effect of changes in exchange rates. We eliminate the effect of exchange rates by recalculating net sales for the relevant period at the exchange rates used for the previous period. Reconciliation of net sales to Company sales at constant exchange rates for the fourth quarter and in 2021
Business net income Sanofi publishes a key non-GAAP indicator. Following the Regeneron shares transaction that was completed on May 29, 2020, the definition of the non-GAAP financial measure “Business net income” has been revised such that Share of profit/(loss) from investments accounted for using the equity method excludes the effects of applying the equity method to the investment in Regeneron. The comparative periods of 2019 presented have been restated to reflect that adjustment. Business net income is defined as net income attributable to equity holders of Sanofi excluding:
(1) Reported in the line items Restructuring costs and similar items and Gains and losses on disposals, and litigation, which are defined in Notes B.19. and B.20. to our consolidated financial statements. Free cash flow Free cash flow is a non-GAAP financial indicator which is reviewed by our management, and which we believe provides useful information to measure the net cash generated from the Company’s operations that is available for strategic investments1 (net of divestments1), for debt repayment, and for capital return to shareholders. Free Cash Flow is determined from the Business Net Income adjusted for depreciation, amortization and impairment, share of profit/loss in associates and joint ventures net of dividends received, gains & losses on disposals, net change in provisions including pensions and other post-employment benefits, deferred taxes, share-based expense and other non-cash items. It comprises net changes in working capital, capital expenditures and other asset acquisitions2 net of disposal proceeds2, and payments related to restructuring and similar items. Free cash flow is not defined by IFRS and it is not a substitute measure for the IFRS aggregate net cash flows in operating activities. 1 Amount of the transaction above a cap of €500 million per transaction (inclusive of all payments related to the transaction). 2 Not exceeding a cap of €500 million per transaction (inclusive of all payments related to the transaction). Reconciliation from net cash provided by/(used in) operating activities to free cash flow
1 Most directly comparable IFRS measure to free cash flow. 2 Includes the impacts of the IFRIC final agenda decisions of March 2021 on the costs of configuring or customising application software used in a Software as a Service (SaaS) arrangement and April 2021 on the attribution of benefits to periods of service. 3 Transactions up to €500 million per transaction. 4 Non IFRS indicator (see definition in Appendix 9). In December 2019, Sanofi announced that it expected to increase its annual Free Cash Flow (see definition above) by approximately 50% by 2022 compared with an adjusted base of €4.1bn in 2018.
2Sanofi has prioritized core assets in its General Medicines portfolio with differentiated and/or established profiles that have significant opportunity for growth in key markets. Core assets include Toujeo, Soliqua, Praluent, Multaq, Lovenox, Plavix and others for total sales of €5.6bn in 2020 3LMIC Low to Middle Income Countries 4See Appendix 3 for 2021 fourth-quarter consolidated income statement; see Appendix 9 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income. 5Not exceeding €500 million per transaction (inclusive of all payments related to the transaction). 6non-GAAP financial measure (definition in Appendix 9). Attachment |
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