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Sanofi at forefront of fight against COVID-19 in Q1 2020

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by April 24, 2020 Press Releases

Sanofi at forefront of fight against COVID-19 in Q1 2020

Rapid and decisive response to COVID-19 global health crisis

  • Sanofi showed resilience and maintained full business continuity worldwide including its global industrial network.
  • Separate collaborations announced with BARDA, Translate Bio and GSK to develop novel COVID-19 vaccines.
  • Global clinical program underway to evaluate Kevzara® in patients hospitalized with severe COVID-19.
  • Initiated two studies evaluating hydroxychloroquine as a treatment for COVID-19. Commitment to donate 100 million doses.
  • In addition, a leading European API company to be created to help balance the industry’s reliance on API sourced from Asia.

Q1 2020 sales growth performance driven by Dupixent®

  • COVID-19 stocking in channels explains about half of company sales growth in Q1; Dupixent® growth unaffected by COVID-19.
  • Net sales were €8,973 million, up 6.9% on a reported basis and 6.6%(1) at CER with Dupixent® sales up 129.8% to €776 million.
  • Specialty Care sales up 31.3% driven by Dupixent® performance and double-digit growth of Aubagio® and Rare Disease.
  • Vaccines sales increased 3.7% reflecting high base for comparison and decline in the travel category.
  • General Medicines sales decline moderated (-3.8%) due to demand for chronic therapies including Diabetes (-1.2%).
  • CHC sales up 4.2% driven by performance in Rest of World region and supported by additional demand related to COVID-19.
  • China sales (-14.4%) impacted mainly by VBP program, partly offset by significant volume gains for Plavix® and CoAprovel®.

Q1 2020 business EPS(2) growth reflected underlying performance and COVID-19 impact

  • Q1 2020 business net income increased 15.9% to €2,042 million and 16.1% at CER.
  • Q1 2020 business EPS(2) was €1.63, up 15.6% at CER, with roughly half of this growth due to COVID-19 impact.
  • IFRS EPS was €1.35 (up 48.4%).

R&D advances and regulatory milestones

  • Detailed phase 2 results for BTK inhibitor (‘168) in multiple sclerosis presented at virtual scientific forum.
  • Positive phase 3 results evaluating Dupixent® in children (6-11 years) with severe AD presented at RAD Virtual Conference.
  • Sarclisa® approved in the U.S. for relapsed refractory multiple myeloma and favorable CHMP opinion received.

Full-year 2020 business EPS(2) guidance affirmed

  • Sanofi continues to expect 2020 business EPS(2) to grow around 5%(3) at CER, barring unforeseen major adverse events. Sanofi expects the favorable first-quarter COVID-19 impact on sales and business EPS to be mainly offset during the second quarter. Applying average April 2020 exchange rates, the currency impact on 2020 business EPS is estimated to be between -1% to -2%.
Sanofi Chief Executive Officer, Paul Hudson, commented:

“I am proud of the way Sanofi employees responded to the immense challenges of the COVID-19 pandemic. They continue to put patients first while embracing and delivering on the new Company strategy. This is exemplified by the multi-pronged approach to fight COVID-19 with the accelerated development of vaccine candidates and therapeutics while sustaining the impressive growth of Dupixent®, the strength of the Vaccines business as well as driving efficiencies and cash flow. In R&D, we took actions to maintain clinical trial programs and to advance our pipeline of potentially transformative medicines. While the duration of the pandemic remains unknown at this point, I am confident Sanofi is well positioned to navigate these challenges and deliver on our commitment to patients.”

 Q1 2020ChangeChange
at CER
IFRS net sales reported€8,973m+6.9%+6.6%
IFRS net income reported€1,683m+48.0%
IFRS EPS reported€1.35+48.4%
Free cash flow(4)€1,558m+90.0%
Business operating income€2,659m+15.8%+15.9%
Business net income(2)€2,042m+15.9%+16.1%
Business EPS(2)€1.63+15.6%+15.6%

(1) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9); (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 9). The consolidated income statement for Q1 2020 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (3) Base for business EPS growth is €5.97, reflecting 2 cents impact from IFRS 16 (Appendix 9); (4) Free cash flow is a non-GAAP financial measure (definition in Appendix 9).

2020 first-quarter Sanofi sales

Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(5).

In the first quarter of 2020, Company sales were €8,973 million, up 6.9% on a reported basis. Exchange rate movements had a positive effect of 0.3 percentage points, mainly driven by the strength of the U.S. dollar and the Japanese yen, partially offset by the decrease in the Brazilian real and the Argentine peso. At CER, Company sales increased 6.6%.

Global Business Units

With effect from January 1, 2020, Sanofi has structured its business into three core Global Business Units (GBUs) to support the Company’s strategy: Specialty Care, General Medicines and Vaccines. Its Consumer Healthcare business is in the process of being established as a standalone business with integrated R&D and manufacturing functions.The table below presents first-quarter 2020 sales by Global Business Unit, including Consumer Healthcare, and by reporting region.

Net sales by GBU
(€ million)
Q1 2020Change
at CER
U.S.Change
at CER
EuropeChange
at CER
Rest of the WorldChange
at CER
Specialty Care 2,695+31.3%1,639+36.8%589+21.2%467+27.2%
Dupixent776+129.8%613+123.7%90+140.5%73+176.9%
Multiple Sclerosis/
Neurology/Other I&I
645+13.2%446+17.9%151+2.7%48+9.3%
Rare Disease794+11.2%280+6.3%268+9.9%246+18.5%
Oncology186+28.7%83+19.4%71+36.5%32+37.5%
Rare Blood Disorder294+3.6%217+1.9%9+80.0%68+3.2%
General Medicines4,069-3.8%742-10.7%1,220+1.4%2,107-4.1%
Diabetes1,282-1.2%375-18.0%325+4.8%582+9.3%
Cardiovascular and Established Rx Products2,787-5.0%367-1.7%895+0.2%1,525-8.4%
Vaccines909+3.7%288+2.9%153+0.7%468+5.1%
Consumer Healthcare 1,300+4.2%  302-5.2%420+6.1%578+8.1%
Total net sales8,973+6.6%2,971+13.1%2,382+6.5%3,620+2.1%

Pharmaceuticals

First-quarter 2020 Pharmaceutical sales were up 7.5% to €6,764 million, mainly driven by Dupixent® and Aubagio®, partially offset by the decline in Plavix® sales in China.

Specialty Care GBU

Dupixent

Net sales (€ million)Q1 2020Change
at CER
Total Dupixent®776+129.8%

Dupixent® (collaboration with Regeneron) generated sales of €776 million in the first quarter (up 129.8%). In the U.S., Dupixent® sales of €613 million (up 123.7%) were driven by continued growth in atopic dermatitis which benefited from increased penetration in adult and adolescent patients, together with rapid uptake in asthma and the most recent launch in chronic rhinosinusitis with nasal polyposis (CRSwNP, approved in June 2019). In the U.S., Dupixent® NBRx and TRx increased strongly compared to the first quarter of 2019, growing at 76% and 118%, respectively. First-quarter sales of Dupixent® in Europe rose to €90 million (up 140.5%) driven by continued growth in atopic dermatitis in key markets and additional launches. In Japan, where sales were €41 million (up 166.7%), a governmental price decrease was implemented on April 1. Dupixent® is now launched in 38 countries for adult atopic dermatitis; among these, Dupixent® is also launched in adolescent atopic dermatitis in 12 countries, in asthma in 14 countries and in CRSwNP in 5 countries. Potentially as many as 68 additional country launches are planned across these indications in the remainder of 2020.

(5) See Appendix 9 for definitions of financial indicators. .

Multiple Sclerosis/Neurology/Other Inflammation & Immunology

Net sales (€ million)Q1 2020Change
at CER
Aubagio®541+21.3%
Lemtrada®49-46.7%
Kevzara®55+80.0%
Total Multiple Sclerosis/ Neurology/Other I&I645+13.2%

First-quarter Multiple Sclerosis/Neurology/Other I&I sales increased 13.2% to €645 million.

First-quarter Aubagio® sales increased 21.3% to €541 million, driven by the U.S. (up 23.0% to €391 million) and European performance (up 21.4% to €118 million). Sales growth reflected increased demand, together with inventory build some of which was partially related to COVID-19, and pricing.

In the first quarter, Lemtrada® sales decreased 46.7% to €49 million due to lower sales in the U.S. (down 43.9% to €23 million) and in Europe (down 69.0% to €13 million), reflecting increased global competition and reduced new patient starts as a result of COVID-19.

Kevzara® (collaboration with Regeneron) sales were €55 million (up 80.0%) in the first quarter, of which €32 million was generated in the U.S. (up 72.2%) and €20 million in Europe (150.0%).

Rare Disease

Net sales (€ million)Q1 2020Change
at CER
Myozyme® / Lumizyme®246+11.8%
Fabrazyme®214+14.6%
Cerezyme®189+9.7%
Aldurazyme®670.0%
Cerdelga®58+20.8%
Others Rare Disease200.0%
Total Rare Disease794+11.2%

In the first quarter, Rare Disease sales increased 11.2% to €794 million. In Europe, sales were up 9.9% (to €268 million), with growth elevated by an increase in stock driven by the COVID-19 pandemic. In the U.S., Rare Disease sales were up 6.3% (to €280 million). Strong Rest of the World growth (up 18.5% to €246 million) reflected ongoing demand trends and favorable timing of favorable tenders.

First-quarter Gaucher (Cerezyme® and Cerdelga®) sales increased 12.1% to €247 million. Cerezyme® sales increased 9.7% to €189 million, sustained by strong performance in Rest of the World (up 20.9% to €76 million). Cerezyme® growth was due to new patient starts and positive phasing of shipments in the Rest of the World. First-quarter Cerdelga® sales increased 20.8% to €58 million, with sales up 41.2% in Europe (to €24 million) and up 7.1% in the U.S. (to €31 million). Cerdelga® growth reflected new patient starts and competitive switches especially in Europe.

First-quarter Pompe (Myozyme®/Lumizyme®) sales grew 11.8% to €246 million,mainly reflecting new patient starts and reduced competition from clinical trials enrolling patients. In the Rest of the World, Myozyme®/Lumizyme® sales were up 28.3% to €55 million. In the U.S. and in Europe, Myozyme®/Lumizyme® sales increased 6.3% (to €87 million) and 8.4% (to €104 million), respectively.

First-quarter Fabry (Fabrazyme®) sales grew 14.6% to €214 million, driven by the Rest of the World (up 28.3% to €58 million). In the U.S. and Europe, Fabrazyme® sales increased 7.4% (to €104 million) and 15.6% (to €52 million), respectively. Growth was driven by new patient starts, especially in Europe and the Rest of the World which also benefited from positive order phasing.

Oncology

Net sales (€ million)Q1 2020 Change
at CER
Jevtana®138+22.5%
Fasturtec®35+9.4%
Libtayo®12
Sarclisa®1
Total Oncology186+28.7%

First-quarter Oncology sales increased 28.7% to €186 million driven by double-digit growth in all regions.

First-quarter Jevtana® sales increased 22.5% to €138 million driven by the U.S. (up 23.4% to €60 million) and Europe (up 18.6% to €51 million). Sales performance benefited from publication of the results of the CARD study in metastatic castration-resistant prostate cancer at ESMO (European Society for Medical Oncology) and in the NEJM (New England Journal of Medicine) in September 2019. In the Rest of the World, Jevtana® sales increased 28.6% (to €27 million).

Libtayo® (collaboration with Regeneron) approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation had ex-U.S. sales of €12 million in the first quarter. Libtayo® has been launched in 12 countries outside the U.S. and 10 additional country launches are planned by the end of 2020. U.S. Libtayo® sales are reported by Regeneron.

Sarclisa® (isatuximab-irfc) was approved by the U.S. Food and Drug Administration (FDA), in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor on March 2, 2020. The U.S. pre-launch was impacted by COVID-19. Sarclisa® also received marketing authorization in Switzerland. In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sarclisa® in RRMM at the end of March.

Rare Blood Disorder

Net sales (€ million)Q1 2020Change
at CER
Eloctate®161-10.9%
Alprolix®109+11.6%
Cablivi®24ns
Total Rare Blood Disorder294+3.6%

First-quarter sales of the Rare Blood Disorder franchise were €294 million, up 3.6%. First-quarter U.S. sales were €217 million, up 1.9%. Non U.S. sales were €77 million with Japan as the primary contributor.

Eloctate® sales were €161 million in the first quarter, down 10.9%. U.S. sales were down 16.1% to €119 million as a result of ongoing competitive pressure. In the Rest of the World, first-quarter Eloctate® sales increased 8.1% to €42 million.

Alprolix® sales were €109 million in the first quarter, up 11.6% driven by the U.S., where sales increased 15.7%  to €83 million reflecting switches from short acting therapies and conversion to prophylaxis treatment. In the Rest of the World, Alprolix® sales were stable at €26 million.

Cablivi® for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) generated first-quarter sales of €24 million. Sales of Cablivi® in the U.S. and Europe were €15 million and €9 million, respectively. In Europe, the product is commercially available in Germany, Denmark, Austria, Belgium, Netherlands, Italy and Finland. Additionally, Cablivi® has a temporary license to be sold in France.

General Medicines GBU

Diabetes

Net sales (€ million)Q1 2020Change
at CER
Lantus®724-6.6%
Toujeo®257+20.9%
Total glargine981-0.7%
Apidra®89+1.1%
Admelog®50-27.3%
Soliqua®37+68.2%
Other diabetes125-4.5%
Total Diabetes 1,282-1.2%

In the first quarter, global Diabetes sales decreased 1.2% to €1,282 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S. which were partly offset by increased sales in the Rest of the World and patient stockpiling due to the COVID-19 pandemic notably in Europe. First-quarter U.S. Diabetes sales were down 18.0% to €375 million, reflecting a continued decline in average U.S. glargine net prices. First-quarter sales in Europe increased 4.8% to €325 million driven by Toujeo®. First-quarter sales in the Rest of the World were up 9.3% to €582 million.

In the first quarter, Lantus® sales were €724 million, down 6.6%. In the U.S., Lantus® sales decreased 21.5% to €230 million, mainly reflecting lower average net price. In Europe, first-quarter Lantus® sales were €149 million, down 3.9% reflecting biosimilar glargine competition and patients switching to Toujeo®. In the Rest of the World, first-quarter Lantus® sales increased 4.8% to €345 million driven by strong performance in China.

First-quarter Toujeo® sales increased 20.9% to €257 million, driven by strong performance in Europe (up 22.0% to €100 million) mainly driven by patient switches from Lantus® to Toujeo® and in the Rest of the World (up 48.3% to €89 million). In the U.S., first-quarter Toujeo® sales were €68 million, down 4.3% mainly reflecting lower average net price.

First-quarter Amaryl® sales decreased 8.9% to €82 million, due to lower sales in China (down 13.2% to €33 million) reflecting the anticipated net price adjustments and inventory reduction in the channel due to the second wave of the nationwide VBP (volume-based procurement) program which includes glimepiride (compound name of Amaryl®). As previously disclosed, Sanofi opted not to bid with Amaryl® and expects sales of Amaryl® in China to decline significantly in 2020.

First-quarter Apidra® sales increased 1.1% to €89 million. Lower sales in the U.S. (down 30.8% to €9 million) offset growth in the Rest of the World (up 9.5% to €46 million) and Europe (up 2.9% to €34 million).

Admelog® (insulin lispro injection) generated sales of €50 million (down 27.3%) in the first quarter. Admelog® sales in the U.S. were €44 million, down 31.7% due to the WAC price adjustment of -44% which took effect on July 1, 2019. Sanofi expects lower Admelog® sales in 2020 due to the full-year impact of the U.S. WAC price adjustment.

First-quarter Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) and Suliqua™ sales increased 68.2% (to €37 million) of which €22 million (up 37.5%) was generated in the U.S.

Cardiovascular and Established Rx Products

Net sales (€ million)Q1 2020 Change
at CER
Lovenox®329-2.9%
Plavix®273-32.7%
Aprovel®/Avapro®174-13.4%
Thymoglobulin®85+3.7%
Multaq®810.0%
Praluent®73+28.6%
Renvela®/Renagel®71-11.4%
Synvisc® /Synvisc-One®58-16.2%
Mozobil®54+20.5%
Eloxatin®47-11.1%
Taxotere®39-17.0%
Generics270-0.4%
Other1,233+2.5%
Total Cardiovascular and Established Rx Products2,787-5.0%

In the first quarter, Cardiovascular and Established Rx Products sales decreased 5.0% to €2,787 million, primarily reflecting the decline in Plavix® and Aprovel® family sales in China due to net price adjustments following the nationwide implementation of the VBP program in December. Excluding China, Cardiovascular and Established Rx Products sales increased 0.6%. Established Rx Products benefited from a favorable impact from COVID-19 on sales of chronic disease treatments, which reflected longer duration prescriptions and patient stocking despite lower sales of hospital-administered therapies.

First-quarter Lovenox® sales decreased 2.9% to €329 million, reflecting lower European sales (down 13.2% to €171 million) due to biosimilar competition in several countries in Europe. In the Rest of the World, Lovenox® sales grew 12.4% to €150 million.

In the first quarter, Plavix® sales were down 32.7% to €273 million, primarily reflecting the decrease in China (sales down 53.5% to €118 million) due to net price adjustments following the implementation of the VBP program. As expected, volume growth of Plavix® increased significantly in China over the quarter. In Japan, Plavix® sales decreased 19.4% to €26 million due to a price reduction in October 2019.

First-quarter Aprovel®/Avapro® sales were down 13.4% to €174 million, primarily reflecting the decrease in China (sales down 32.7% to €68 million) due to net price adjustments following implementation of the VBP program. As expected, volume growth of Aprovel® family increased significantly in China over the quarter.

As previously announced, Sanofi expects sales of Plavix® and the Aprovel® family in China to decline by around 50% in 2020 due to implementation of the VBP program. In the first quarter 2020, volume growth of Plavix® and CoAprovel® increased more than 60% in China in line with Sanofi’s full-year expectations.

First-quarter Praluent® sales increased 28.6% to €73 million, driven by the U.S. (up 55.0% to €32 million) and Rest of the World (up 83.3% to €11million). In Europe, Praluent® sales were stable at €30 million reflecting the suspension of sales in Germany in August 2019 following the Regional Court of Dusseldorf ruling in the ongoing patent litigation.

On April 6, Sanofi announced that it had finalized the planned restructuring related to Praluent® 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. The restructuring simplifies the antibody collaboration, increases efficiency and streamlines operations for Praluent®. As a consequence, Sanofi will no longer consolidate Praluent sales in the U.S. from April 1.

First-quarter Renvela®/Renagel® (sevelamer) sales decreased 11.4% to €71 million, due to generic competition in the U.S. (down 29.7% to €26 million) and despite growth in China.

First-quarter sales of Eloxatin® and Taxotere® were down 11.1% (€47 million) and down 17.0% (€39 million), respectively driven by lower sales in China reflecting the adverse impact of COVID-19 on sales of hospital-administered drugs.

Vaccines GBU

Net sales (€ million)Q1 2020 Change
at CER
Polio/Pertussis/Hib vaccines
(incl. Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®)
484-0.8%
Meningitis/Pneumo vaccines
(incl. Menactra®)
131+16.1%
Adult Booster vaccines (incl. Adacel ®)115+14.0%
Travel and other endemic vaccines99-17.6%
Influenza vaccines
(incl. Vaxigrip®, Fluzone HD®, Fluzone® & Flublok®)
63+100.0%
Other vaccines17-29.2%
Total Vaccines909+3.7%

First-quarter Vaccines sales increased 3.7% to €909 million reflecting the high base for comparison (first-quarter 2019 Vaccines sales increased by 20.1%). Performance was driven by Rest of the World (up 5.1% to €468 million). In the U.S. and Europe, first-quarter Vaccines sales were up 2.9% (to €288 million) and up 0.7% (to €153 million), respectively. The impact from COVID-19 was marginal in the first quarter, as favorable effects on influenza vaccines sales were offset by negative impacts on travel vaccines.

In the first quarter, Polio/Pertussis/Hib (PPH) vaccines sales decreased 0.8% to €484 million due to a 3.5% decrease in Rest of the World (to €306 million) relecting the high base for comparison (in the first quarter of 2019, PPH vaccines sales benefited from favorable phasing in Japan). In the U.S., first quarter PPH vaccines sales were up 9.8% to €104 million driven by Pentacel® and Quadracel®. In Europe, PPH vaccines sales were down 2.6% to €74 million.

First-quarter Menactra® sales increased 16.1% to €131 million, reflecting a tender awarded in Brazil.

First-quarter Adult Booster vaccines sales were up 14.0% to €115 million, reflecting favorable phasing in Europe (up 24.3% to €46 million).

First-quarter Travel and other endemic vaccines sales were €99 million, down 17.6%, reflecting travel restrictions related to COVID-19.

Influenza vaccines sales increased strongly (up 100.0%) to €63 million in the first quarter, reflecting the late season in the north hemisphere and higher vaccines delivery in the south hemisphere favorably impacted by COVID-19.

Consumer Healthcare

CHC sales by geography and category are provided in Appendix 1.

Net sales (€ million)Q1 2020 Change
at CER
Allergy Cough & Cold398+8.5%
  of which Allegra®147+8.1%
  of which Mucosolvan®34+21.4%
  of which Xyzal®17+14.3%
Pain358+13.1%
  of which Doliprane®95+20.3%
  of which Buscopan®50+17.0%
Digestive232-12.7%
  of which Dulcolax®57+3.6%
  of which Enterogermina®62+8.6%
  of which Essentiale®44-10.2%
  of which Zantac®0-100%
Nutritionals154+8.3%
Other158+0.6%
  of which Gold Bond®56+3.8%
Total Consumer Healthcare1,300+4.2%

In the first quarter, Consumer Healthcare (CHC) sales increased 4.2% to €1,300 million. Sales growth in the quarter benefited from higher demand related to COVID-19. This performance more than offset the impact of the Zantac® voluntary recall, divestments of non-core products and product suspensions due to changing regulatory requirements.

In September 2019, the U.S. Food and Drug Administration (FDA) and Health Canada issued public statements alerting that some ranitidine medicines, including Zantac® OTC, could contain NDMA at low levels and asked manufacturers to conduct testing. Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi decided to conduct the voluntary recall in the U.S. and Canada in October 2019. On April 1, 2020, the FDA requested the immediate removal of all ranitidine medicines from the U.S. market.

In Europe, first-quarter CHC sales increased 6.1% to €420 million, reflecting demand related to COVID-19 for Pain and Cough & Cold products particularly Doliprane® in France. Pain category sales increased 14.4% to €159 million. First-quarter sales of the Allergy, Cough & Cold and Digestive categories showed growth of 3.6% (to €115 million) and 3.3% (to €93 million), respectively.

In the U.S., first-quarter CHC sales decreased 5.2% to €302 million, reflecting the impact of the Zantac® recall (-€28 million) which was partially offset by consumer stockpiling due to COVID-19. First-quarter sales of the Pain and Allergy, Cough & Cold categories showed growth of 8.9% (to €51 million) and 1.9% (to €112 million), respectively. Gold Bond sales increased 3.8% due to strong demand increase.

In the Rest of the World, first-quarter CHC sales increased 8.1% to €578 million, driven by double-digit growth in Allergy, Cough & Cold (up 17.1% to €171 million), Pain (up 13.3% to €148 million) and Nutritional (up 12.0% to €108 million) categories, supported by continued underlying demand as well as a favorable COVID-19 impact.

Company sales by geographic region   

Sanofi sales (€ million)Q1 2020Change
at CER
United States2,971+13.1%
Europe2,382+6.5%
Rest of the World3,620+2.1%
  of which China680-14.4%
  of which Japan505-8.6%
  of which Brazil270+14.6%
  of which Russia194+15.7%
Total Sanofi sales8,973+6.6%

First-quarter sales in the U.S. increased 13.1% to €2,971 million, driven mainly by the strong performance of Dupixent®. Aubagio® also contributed to U.S. growth in part due to higher inventories partially related with the COVID-19 environment.

First-quarter sales in Europe were up 6.5% to €2,382 million, driven by Dupixent®, Rare Disease, CHC, Aubagio® and oncology performance. As noted, sales in some categories in Europe (notably chronic diseases within General Medicines, including Diabetes, and CHC) were significantly impacted by patient stocking associated with COVID-19.

In the Rest of the World, sales increased 2.1% to €3,620 million in the first quarter, driven by Diabetes, Dupixent®, Rare Disease and CHC performance which was partially offset by lower sales of Plavix® and Aprovel®. Sales in China decreased 14.4% to €680 million, impacted by lower sales of Plavix® and the Aprovel® family due to the VBP program despite significant combined volume growth for the two products. Sales of the non-VBP portfolio in China grew 14.9% in the first quarter. In Japan, first-quarter sales decreased 8.6% to €505 million, reflecting lower sales of Vaccines and Cardiovascular & Established Products despite the strong demand for Dupixent®. In Brazil, first-quarter sales were up 14.6% to €270 million driven by Rare Disease and Vaccines.

R&D update

Consult Appendix 7 for full overview of Sanofi’s R&D pipeline

Regulatory update

Regulatory updates since February 6, 2020 include the following:

  • In April, Efluelda® (Quadrivalent Influenza Vaccine-High Dose) obtained a positive end of the European procedure (decentralized procedure) for active immunization in adults aged 65 years of age and older for the prevention of influenza disease, allowing national licenses to be issued.
  • In March, Sarclisa® (isatixumab-irfc) was approved by the U.S. Food and Drug Administration (FDA) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. At the end of March, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) also adopted a positive opinion for Sarclisa® in combination with pom-dex for the treatment of adult RRMM who have received at least two prior therapies.

At the end of April 2020, the R&D pipeline contained 87 projects, including 35 new molecular entities in clinical development (or that have been submitted to the regulatory authorities). 39 projects are in phase 3 or have been submitted to the regulatory authorities for approval.

Portfolio update

Phase 3:

  • Pivotal phase 3 results evaluating Dupixent® (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged 6-11 years with uncontrolled severe atopic dermatitis were presented during a session at the 2020 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on April 5. These results demonstrated that Dupixent® combined with standard-of-care TCS significantly improved disease signs, symptoms and health-related quality of life. Sanofi and Regeneron previously announced positive topline results from this trial in August 2019.
  • Sanofi and Regeneron Initiated a global clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. Kevzara® inhibits IL-6, which may play a role in driving the inflammatory immune response that causes acute respiratory distress syndrome observed in patients with severe COVID-19 infection. Sanofi is leading trials outside the U.S., while Regeneron is leading U.S. trials.
  • Two studies were initiated to evaluate Plaquenil® (hydroxychloroquine) as a potential treatment for COVID-19.
  • A phase 3 study initiated to evaluate venglustat (GZ402671), an oral GCS Inhibitor, in the treatment of GM2 gangliosidosis, is pending the first patient enrollment.
  • A phase 3 study initiated to evaluate Sarclisa® (isatuximab), in the treatment of smoldering multiple myeloma, is pending the first patient enrollment.

 

Phase 2

  • A phase 2 study evaluating Sarclisa® (isatuximab-irfc) was initiated in patients awaiting kidney transplantation.
  • The development of SAR440340 (collaboration with Regeneron), an anti-IL33 monoclonal antibody, in atopic dermatitis was discontinued due to lack of efficacy.

Collaboration

  • On April 14, Sanofi and GSK announced that they had signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. GSK will contribute its proven pandemic adjuvant technology
  • On March 27, Sanofi announced a collaboration with Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, to develop a novel mRNA vaccine for COVID-19. This collaboration leverages an existing agreement from 2018 between the two companies to develop mRNA vaccines for infectious diseases.
  • On February 18, Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA). Sanofi Pasteur, will use its recombinant DNA platform and leverage previous development work for a SARS vaccine which may unlock a fast path forward for developing a novel COVID-19 vaccine.
  • On April 16, Sanofi and Luminostics announced that they had signed an agreement to evaluate a collaboration on a unique self-testing solution for COVID-19, using Luminostics innovative technology, and further adding to Sanofi’s ongoing efforts to fight the COVID-19 pandemic on multiple fronts.

2020 first-quarter financial results(6)

Business Net Income(6)

In the first quarter of 2020, Sanofi generated net sales of €8,973 million, an increase of 6.9% and 6.6% at CER. About half of sales growth at CER was due to the net impact of COVID-19.

First-quarter other revenues increased 6.5% (up 3.4% at CER) to €343 million, including the VaxServe sales contribution of non-Sanofi products (€286 million, up 14.9% at CER).

First-quarter Gross Profit increased 6.1% to €6,469 million (up 5.5% at CER). The gross margin ratio decreased 0.6 percentage points to 72.1% (71.9% at CER) versus the first quarter of 2019. The negative impact from net price adjustments of Plavix® and the Aprovel® family in China and U.S. Diabetes net price evolution more than offset the favorable impact from Specialty Care growth and industrial productivity. In the first quarter of 2020, the gross margin ratio of segments were 74.8% for Pharmaceuticals (down 1.1 percentage points), 64.6% for Vaccines (up 2.3 percentage points) and 67.9% for CHC (down 1.3 percentage points).

Research and Development (R&D) expenses decreased 3.2% to €1,340 million in the first quarter of 2020. At CER, R&D expenses decreased 4.3% reflecting smart spending initiatives as well as a decline in Diabetes R&D expenses. In the first quarter, the ratio of R&D to sales decreased 1.6 percentage points to 14.9% compared to the first quarter of 2019.

First-quarter selling general and administrative expenses (SG&A) decreased 1.4% to €2,342 million. At CER, SG&A expenses were down 2.1%, reflecting smart spending initiatives. In the first quarter, the ratio of SG&A to sales decreased 2.2 percentage points to 26.1% compared to the first quarter of 2019.

First-quarter operating expenses were €3,682 million, a decrease of 2.1% and 2.9% at CER.

First-quarter other current operating income net of expenses was -€247 million versus -€102 million in the first quarter of 2019. In the first quarter of 2020, this line included an expense of €243 million (versus a €75 million expense in the first quarter of 2019) 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.

The share of profit from associates was €131 million in the first quarter versus €71 million in the first quarter of 2019. The majority of the increase was due to discrete items in the equity accounting treatment of Sanofi’s ownership in Regeneron, including adjustments related to IFRS versus U.S. GAAP and prior period true-up based on actual reported results.

In the first quarter, non-controlling interests were -€12 million versus -€10 million in prior period.

First-quarter business operating income (BOI) increased 15.8% to €2,659 million. At CER, BOI increased 15.9%. The ratio of BOI to net sales increased 2.2 percentage points to 29.6% versus the first quarter of 2019. Over the period, the BOI ratio of segments were 39.4% for Pharmaceuticals (up 2.5 percentage points), 26.8% for Vaccines (down 0.2 percentage points) and 37.1% for CHC (up 0.2 percentage points).

Net financial expenses were -€75 million in the first quarter versus -€54 million in the same period of 2019. The first quarter of 2019 included a €26 million financial gain in connection with contingent payments on future regulatory milestones.

First-quarter effective tax rate was stable at 22.0% versus the prior period. Sanofi continues to expect its effective tax rate to be around 22% in 2020.

First-quarter business net income(6) increased 15.9% to €2,042 million and increased 16.1% at CER. The ratio of business net income to net sales increased 1.8 percentage points to 22.8% versus the first quarter of 2019.

In the first quarter of 2020, business earnings per share(6) (EPS) increased 15.6% to €1.63 on both a reported basis and at CER, with roughly half of this growth due to the COVID-19 impact. The average number of shares outstanding was 1,251.3 million versus 1,245.8 million in the first quarter of 2019.

(6) See Appendix 3 for 2020 first-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.

Reconciliation of IFRS net income reported to business net income (see Appendix 4)

In the first quarter of 2020, the IFRS net income was €1,683 million. The main items excluded from the business net income were:

  • An amortization charge of €457 million related to fair value remeasurement on intangible assets of acquired companies (primarily Genzyme: €162 million, Bioverativ: €85 million, Boehringer Ingelheim CHC business: €51 million, Aventis: €35 million) and to acquired intangible assets (licenses/products: €22 million). These items have no cash impact on the Company.
  • An impairment of intangible assets of €85 million mainly related to discontinued Diabetes projects.
  • Restructuring costs and similar items of €66 million.
  • A pre-tax gain of €108 million arising from the divestment of Seprafilm to Baxter.
  • A €108 million tax effect arising from the items listed above, mainly comprising €142 million of deferred taxes generated by amortization and impairments of intangible assets and €20 million associated with restructuring costs and similar items. (see Appendix 4).
  • An income of €27 million net of tax related to restructuring costs of associates and joint ventures and expenses arising from the impact of acquisitions on associates and joint ventures.

Capital Allocation

In the first quarter of 2020, free cash flow(7) increased by 90.0% to €1,558 million, after net changes in working capital (-€414 million), capital expenditures (-€319 million) and other asset acquisitions1 (-€165 million) net of disposal proceeds1 (€448 million), and payments related to restructuring and similar items (-€277 million). Over the period, acquisitions2 were €2,245 million (related to Synthorx). As a consequence, net debt increased from €15,107 million at December 31, 2019, to €16,191 million at March 31, 2020 (amount net of €7,279 million cash and cash equivalents).
1Not exceeding €500 million per transaction.
 2Amount of the transaction above €500 million per transaction.

 (7) non-GAAP financial measure (definition in Appendix 9).

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, 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, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Appendices

List of appendices

Appendix 1:2020 first-quarter net sales by GBU, franchise, geographic region and product
Appendix 2:2020 first-quarter business net income statement
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