Sanofi delivers strong 2019 business EPS growth of 6.8% at CER

Sanofi delivers strong 2019 business EPS growth of 6.8% at CER

 Q4 2019ChangeChange
at CER
at CER
IFRS net sales reported€9,608m+6.8%+4.7%€36,126m+4.8%+2.8%
IFRS net income reported-€10m-103.9%(2)€2,806m-34.8%(2)
IFRS EPS reported-€0.01-105.0%(2)€2.24-35.1%(2)
Business net income(1)€1,684m+23.5%+18.4%€7,489m+9.8%+7.0%
Business EPS(1€1.34+21.8%+17.3%€5.99+9.5%+6.8%
Fourth-quarter 2019 sales performance(3) driven by Dupixent® and Vaccines

  • Net sales were €9,608 million, up 6.8% on a reported basis and 4.7%(3) at CER.
  • Dupixent® (global sales €679 million, up 135%) the largest growth contributor, drove Sanofi Genzyme GBU sales up 19.7%.
  • Vaccines sales increased 22.0%, reflecting majority of U.S. influenza vaccine shipments in Q4.
  • CHC sales down 5.2%, mainly due to Zantac® voluntary recall, non-core divestments and changing regulatory requirements.
  • Primary Care GBU sales declined 8.7% due to lower sales in Diabetes and Established Products.
  • Lower China sales (down 21.0%) due to anticipated price and inventory adjustments on Plavix® and Avapro® in the channel.

Full-year 2019 sales growth of 3.6% at CER/CS(4) and business EPS growth of 6.8% at CER

  • Net sales were €36,126 million, up 4.8% on a reported basis and 2.8% at CER (up 3.6% at CER/CS(4)).
  • Dupixent® sales reached €2,074 million, on track with ambition to achieve more than €10 billion peak sales.
  • Vaccines sales increased 9.3% to €5,731 million, supporting expected mid-to-high single digit CAGR from 2018 to 2025.
  • Business operating income margin improved 1.2 percentage points to 27.0%, trending towards objective of 30% by 2022.
  • Q4 2019 business EPS(1) up 17.3% at CER to €1.34.
  • Full-year 2019 business EPS of €5.99 up 6.8% at CER.
  • Full-year 2019 IFRS EPS of €2.24 (down 35.1%(2)), reflecting a €3.6 billion impairment charge mainly related to Eloctate®.
  • Board proposes annual dividend of €3.15, the 26th consecutive increase in dividend.

Significant R&D advances and regulatory milestones

  • SAR442168, a BTK inhibitor, achieved proof of concept in relapsing multiple sclerosis; phase 3 program to be initiated mid-2020.
  • Dupixent® submitted to FDA (priority review) and EMA as first biologic for children aged 6-11 years with atopic dermatitis.
  • Dupixent® phase 3 pivotal studies initiated in bullous pemphigoid, chronic spontaneous urticaria and prurigo nodularis.
  • Dupixent® efficacy and safety further supported by 3-year data from OLE (Open Label Extension) study.
  • Fluzone® High-Dose Quadrivalent approved in the U.S.
  • Sutimlimab demonstrated positive phase 3 results in cold agglutinin disease.
  • SAR408701, an anti-CEACAM5 antibody-drug conjugate, entered into phase 3 in non-small cell lung cancer.
  • Olipudase demonstrated positive pivotal topline data in adult and pediatric patients with acid sphingomyelinase deficiency.
  • Successful completion of Synthorx acquisition enhances Sanofi’s position as an emerging leader in oncology and immunology.

2020 financial outlook
Sanofi expects 2020 business EPS(1) to grow around 5%(5) at CER, barring unforeseen major adverse events. Applying average January 2020 exchange rates, the positive currency impact on 2020 business EPS is estimated to be around 1%.

Sanofi Chief Executive Officer, Paul Hudson, commented:

“I am encouraged by the fourth quarter results which position Sanofi to deliver on our new strategic priorities. The acceleration in sales performance was mainly driven by the impressive growth of Dupixent®, our transformative medicine for type 2 inflammatory diseases and by our differentiated Vaccines portfolio. At the same time, our sharpened focus on operating and financial efficiencies helped us to deliver margin expansion and significant cash flow improvement. We are making great progress in our ambition to transform Sanofi R&D and I am particularly excited by the positive proof of concept data for our BTK inhibitor, a potentially practice changing therapy for multiple sclerosis, announced today. There is increasing momentum across the entire Sanofi organization and I am confident we will achieve the long-term growth aspirations and margin targets we set out at our Capital Markets Day”.

(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 (see Appendix 11 for definitions). The consolidated income statement for Q4 2019 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) Q4 2019 and full-year 2019 included impairment charge of €1,581 million and €3,604 million, respectively, mainly related to Eloctate®; (3) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 11); (4) Constant Structure: Adjusted for divestment of European generics business and sales of Bioverativ products to SOBI; (5) Base for business EPS growth is €5.97, reflecting 2 cents impact from IFRS 16 (see appendix 11).

Investor Relations: (+) 33 1 53 77 45 45 – E-mail: IR@sanofi.comMedia Relations: (+) 33 1 53 77 46 46 – E-mail:

2019 fourth-quarter and full-year Sanofi sales

Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(6).

In the fourth quarter of 2019, Company sales were €9,608 million, up 6.8% on a reported basis. Exchange rate movements had a positive effect of 2.1 percentage points, mainly driven by the strength of the U.S. dollar and the Japanese yen. At CER, Company sales increased 4.7%. Full-year 2019 Company sales reached €36,126 million, up 4.8% on a reported basis. Exchange rate movements had a favorable effect of 2.0 percentage points. At CER, Company sales were up 2.8%.

Global Business Units

At its Capital Markets Day in December 2019, Sanofi announced plans for a new GBU organization(7) which will include three core GBUs, Specialty Care, General Medicines and Vaccines together with a standalone Consumer Healthcare business. The General Medicines GBU will be created from two existing GBUs, Primary Care and China & Emerging Markets. Each GBU will include its respective Emerging Markets sales contribution.
Olivier Charmeil has been appointed to lead the General Medicines GBU. Olivier is one of Sanofi’s most seasoned business leaders. He will draw on his recent experience leading the China & Emerging Markets GBU to engage with customers and markets and ensure that our combined Diabetes, Cardiovascular and Established Products business drives growth and deliver for patients around the world.
Alongside the GBU reorganization, Sanofi will implement changes in the configuration of its Executive Committee. This leadership committee will now include, in addition to the four GBU Heads, the global Heads of R&D, Industrial Affairs, Finance, Human Resources and Legal, together with the Chief Digital Officer. A leaner configuration will foster agility and speed in decision-making, in line with the fourth priority of the company’s new strategy (“Reinvent How We Work”).

The table below presents sales by Global Business Unit (GBU).

Net Sales by GBU
(€ million)
Q4 2019Change
at CER
at CER
Sanofi Genzyme (Specialty Care)(a)2,525 +19.7%9,195+22.4%(c)
Primary Care(a)2,325 -8.7%9,076-14.8%(d)
China & Emerging Markets(b)1,698 -1.9%7,437+6.4%
Total Pharmaceuticals6,548+2.4%25,708+2.2%
Consumer Healthcare (CHC)1,152-5.2%4,687-0.8%
Sanofi Pasteur (Vaccines)1,908+22.0%5,731+9.3%
Total net sales9,608+4.7%36,126+2.8%(e)

(a) Does not include China & Emerging Markets sales – see definition page 9; (b) Includes Emerging Markets sales for Primary Care and Specialty Care; (c) +19.3% at CS -Adjusted for Bioverativ acquisition and sales of Bioverativ products to SOBI – see page 5; (d) -10.9% at CS; (e) +3.6% at CS – Adjusted for Bioverativ and sales of Bioverativ products to SOBI and disposal of European Generics business.

Global Franchises

The tables below present fourth-quarter and full-year 2019 sales by global franchise, including Emerging Markets sales, to facilitate comparisons. Appendix 1 provides a reconciliation of sales by GBU and franchise.

Net sales by Franchise
(€ million)
Q4 2019Change
at CER
at CER
at CER
Specialty Care franchises2,830+18.9%2,525+19.7%305+12.8%
Rare Disease815+1.6%661+0.8%154+5.3%
Multiple Sclerosis540-3.0%517-3.8%23+21.1%
Rare Blood Disorder301-0.7%293-2.4%8ns
Primary Care franchises3,718-7.2%2,325-8.7%1,393-4.7%
Established Rx Products2,276-6.3%1,299-4.0%977-9.3%
Consumer Healthcare 1,152-5.2%  727-9.4%425+3.0%
Total net sales9,608+4.7%6,933+5.9%2,675+1.8%

(6) See Appendix 11 for definitions of financial indicators. (7) subject to consultation with social partners and works councils.

Net sales by Franchise
(€ million)
at CER
at CER
at CER
Specialty Care franchises10,431+22.7%(1)9,195+22.4%1,236+24.4%
Rare Disease3,165+6.5%2,551+2.6%614+24.0%
Multiple Sclerosis2,160+1.8%2,080+1.3%80+14.7%
Rare Blood Disorder1,152+22.0%(2)1,131+20.0%(3)21ns
Primary Care franchises15,277-8.2%(4)9,076-14.8%(5)6,201+3.3%
Established Rx Products(6)9,559-8.3%(7)5,088-15.0%(8)4,471+0.6%
Consumer Healthcare 4,687-0.8%3,035-3.6%1,652+4.7%
Total net sales36,126+2.8%(9)25,212+0.4%(10)10,914+8.7%

(1) +19.9 % at CS- Adjusted for Bioverativ and sales of products to SOBI – see page 5; (2) +0.8% at CS- see page 5; (3) -0.8% at CS -see page 5; (4) -5.5% at CS;
(5) -10.9% at CS; (6) including Generics; (7) -4.1% at CS; (8) -7.9% at CS; (9) +3.6% at CS- Adjusted for Bioverativ and sales of Bioverativ products to SOBI and disposal of European Generics business;(10) +1.5% at CS –
Adjusted for Bioverativ and sales of Bioverativ products to SOBI and disposal of European Generics business.


Fourth-quarter Pharmaceutical sales were up 2.4% to €6,548 million, mainly driven by Dupixent® which was partially offset by Diabetes and Established Rx Products. Full-year 2019 sales for Pharmaceuticals increased 2.2% (up 3.3% at CS) to €25,708 million, reflecting the disposal of the European generics business at the end of the third quarter of 2018.

Specialty Care franchises

Immunology franchise

Net sales (€ million)Q4 2019Change
at CER
at CER
Total Immunology733+128.6%2,259+148.1%

Dupixent® (collaboration with Regeneron) generated sales of €679 million in the fourth quarter (up 135%). In the U.S., Dupixent® sales of €545 million (up 135%) were driven by continued growth in atopic dermatitis which benefited from increased penetration in adult patients and launch in the adolescent age group (12 to 17 years of age) in March, together with rapid uptake in asthma and launch in chronic rhinosinusitis with nasal polyposis (CRSwNP, approved in June). In the U.S., Dupixent® NBRx and TRx more than doubled in the quarter compared to the fourth quarter of 2018, growing at 108% and 117%, respectively. Fourth-quarter sales of Dupixent® in Europe rose to €64 million (up 117%) following additional launches while sales in Japan were €46 million (versus €13 million in the fourth quarter of 2018). Full-year 2019 Dupixent® sales increased 152% to €2,074 million. Dupixent® is now launched in 34 countries for adult atopic dermatitis; among these, Dupixent® is also launched in adolescent atopic dermatitis in 10 countries, in asthma in 8 countries and in CRSwNP in 4 countries. Potentially as many as 89 additional country launches are planned across these indications for 2020.

Kevzara® (collaboration with Regeneron) sales were €54 million (up 68%) in the fourth quarter, of which €34 million was generated in the U.S. (up 39%). Full-year 2019 Kevzara® sales increased 114% to €185 million.

Multiple Sclerosis franchise

Net sales (€ million)Q4 2019Change
at CER
at CER
Total Multiple Sclerosis540-3.0%2,160+1.8%

Fourth-quarter Multiple Sclerosis (MS) sales decreased 3.0% to €540 million. Over the period, Aubagio® sales growth in the U.S. was more than offset by lower Lemtrada® sales. Full-year 2019 MS sales increased 1.8% to €2,160 million.

Fourth-quarter Aubagio® sales increased 5.4% to €482 million, driven by the U.S. performance (up 7.1% to €343 million). Full-year 2019 Aubagio® sales increased 10.0% to €1,879 million. As of January 1, Aubagio® was excluded from the national formulary at ESI, which covers roughly 14% of total commercial lives in the US. Contracted access positions for Aubagio® remain strong for other national health plans and national PBMs.

In the fourth quarter, Lemtrada® sales decreased 42% to €58 million due to lower sales in the U.S. (down 29% to €34 million) and in Europe (down 57% to €16 million), reflecting increased global competition and the update to the EU label. Full-year 2019 Lemtrada® sales decreased 32% to €281 million.

Oncology franchise

Net sales (€ million)Q4 2019 Change
at CER
2019 Change
at CER
Total Oncology441+11.4%1,695+10.6%

Fourth-quarter Oncology sales increased 11.4% to €441 million driven by the U.S. (up 18.4% to €174 million) and Europe (up 15.7% to €102 million). Full-year 2019 Oncology sales increased 10.6% to €1,695 million.

Fourth-quarter Jevtana® sales increased 9.6% to €128 million driven by the U.S. and by publication of the results of the CARD study in metastatic castration-resistant prostate cancer at ESMO (European Society for Medical Oncology) in September 2019. Full-year 2019 Jevtana® sales were up 11.1% to €484 million. In the fourth quarter, Thymoglobulin® sales increased 12.8% to €89 million, driven by the U.S.  2019 sales of Thymoglobulin® increased 16.5% to €354 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 and €16 million in the fourth quarter and full-year 2019, respectively. In 2019 Libtayo® was launched in 7 countries outside the U.S. and there are 13 additional country launches planned by the end of 2020. U.S. Libtayo® sales are reported by Regeneron.

Rare Disease franchise

Net sales (€ million)Q4 2019Change
at CER
at CER
Myozyme® / Lumizyme®238+4.4%918+8.3%
Others Rare Disease76+1.4%296+0.7%
Total Rare Disease815+1.6%3,165+6.5%

In the fourth quarter, Rare Disease sales increased 1.6% to €815 million against a high base for comparison. This performance was driven by Emerging Markets (up 5.3% to €154 million) and the U.S. (up 2.7% to €309 million). In Europe, over the period, sales were flat at €263 million. Full-year 2019 Rare Disease sales increased 6.5% to €3,165 million.

Fourth-quarter Gaucher (Cerezyme® and Cerdelga®) sales decreased 1.3% to €232 million, impacted by Cerezyme® sales phasing effects in Emerging Markets which offset strong Cerdelga® performance. Fourth-quarter Cerdelga® sales increased 22.7% to €55 million, with sales up 18.8% in Europe (to €20 million) and up 19.2% in the U.S. (to €31 million). Full-year 2019 Gaucher sales were €914 million, up 7.0%.
Fourth-quarter Pompe (Myozyme®/Lumizyme®) sales grew 4.4% to €238 million, driven by the U.S. (up 7.6% to €88 million) and Emerging Markets (up 16.7% to €41 million) and supported by positive trends in naïve patient accrual. Full-year 2019 Myozyme®/Lumizyme® sales increased 8.3% to €918 million.

Fourth-quarter Fabry (Fabrazyme®) sales grew 2.4% to €215 million, driven by Emerging Markets (up 15.4% to €29 million) and Europe (up 6.7% to €48 million). Over the period, U.S. sales decreased 1.0% to €106 million. Full-year 2019 Fabrazyme® sales were up 5.3% to €813 million.

Rare Blood Disorder franchise

Net sales (€ million)Q4 2019Change
at CER
at CER
Total Rare Blood Disorder301-0.7%1,152+22.0%***

* -11.6% at CS in 2019 – see footnote 8; **+12.4% at CS in 2019  – see footnote 8; *** +0.8% at CS in 2019 – see footnote 8

Bioverativ was consolidated in Sanofi’s Financial Statements from March 9, 2018. Fourth-quarter sales of the Rare Blood Disorder franchise were €301 million, down 0.7%. Fourth-quarter U.S. sales were €210 million, down 13.6%. Non U.S. sales were €91 million with Japan as the primary contributor. Full-year 2019 sales of the Rare Blood Disorder franchise were €1,152 million, up 0.8% at CS(8).

Eloctate® sales were €177 million in the fourth quarter, down 12.8%. In the U.S., sales of the product decreased 25.6% to €123 million, reflecting ongoing competitive pressure. In the Rest of the World region, fourth-quarter Eloctate® sales increased 35.3% to €47 million. Full-year 2019 Eloctate® sales were €684 million, down 11.6% at CS(8).

Alprolix® sales were €108 million in the fourth quarter, up 9.5%. In the U.S., sales of the product decreased 1.3%  to €77 million, related to shipment timing. In the Rest of the World region, Alprolix® sales increased 47.4% to €30 million due to growth in product sales to SOBI. Full-year 2019 Alprolix® sales were €412 million, up 12.4% at CS(8).

Cablivi® for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) generated fourth-quarter sales of €16 million. The number of patients treated with Cablivi increased over 30% compared to the third quarter to approximately 150 patients. Sales were sequentially lower primarily due to price adjustments in Europe and increased assistance program participations in the U.S. In the U.S., where Cablivi® was launched in April, sales were €10 million. In Europe, the product is commercially available in Germany, Denmark, Austria, Belgium and the Netherlands. Cablivi® has a temporary license to be sold in France. Full-year 2019 Cablivi® sales were €56 million.

Primary Care franchises

Cardiovascular franchise

Net sales (€ million)Q4 2019Change
at CER
at CER
Total cardiovascular franchise174-4.5%605-4.6%

Fourth-quarter Praluent® (collaboration with Regeneron) sales decreased 11.0% to €75 million, reflecting lower sales in the U.S. (down 26.9% to €39 million) which were impacted by significantly higher rebates. In Europe, Praluent® sales increased 4.3% to €24 million despite the suspension of sales in Germany in August following the Regional Court of Dusseldorf ruling in the ongoing patent litigation. Full-year 2019 Praluent® sales decreased 3.8% to €258 million.

In December 2019, Sanofi and Regeneron announced their intent to simplify their antibody collaboration for Kevzara® and Praluent® by restructuring into a royalty-based agreement. Under the proposed restructuring, Sanofi is expected to gain sole global rights to Kevzara® and sole ex-U.S. rights to Praluent®. Regeneron is expected to gain sole U.S. rights to Praluent®. Under the proposed terms of the agreement, each party will be solely responsible for funding development and commercialization expenses in their respective territories. These changes are expected to increase efficiency and streamline operations for the products. Completion of the agreement is expected to be finalized in the first quarter of 2020.

(8) Growth comparing 2019 sales versus full 2018 sales at CER. Sales of products to SOBI were initially recorded in “other revenues” in H1 2018 and in sales from H2 2018; the H1 2018 reclassification was reflected in Q3 2018. H1 2018 and Q3 2018 sales were adjusted accordingly for calculation of CS. Unaudited data.
Diabetes franchise

Net sales (€ million)Q4 2019Change
at CER
at CER
Total glargine963-12.2%3,895-13.2%
Total Diabetes 1,268-9.2%5,113-8.2%

In the fourth quarter, global Diabetes sales decreased 9.2% to €1,268 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S.  Fourth-quarter U.S. Diabetes sales were down 20.5% to €454 million, reflecting the increased contribution to the coverage gap related to Medicare Part D and a continued decline in average U.S. glargine net prices. Fourth-quarter sales in Emerging Markets increased 7.4% to €407 million. Fourth-quarter sales in Europe decreased 4.4% to €305 million despite Toujeo® growth. Full-year 2019 global Diabetes sales decreased 8.2% to €5,113 million. Broad U.S. payer coverage for key Diabetes brands is expected to be largely maintained in 2020.

In the fourth quarter, Lantus® sales were €729 million, down 17.2%. In the U.S., Lantus® sales decreased 26.9% to €286 million, mainly reflecting lower average net price and the increased contribution to the coverage gap related to Medicare Part D. In Europe, fourth-quarter Lantus® sales were €146 million, down 13.1% due to biosimilar glargine competition and patients switching to Toujeo®. In Emerging Markets, fourth-quarter Lantus® sales were stable at €244 million reflecting lower sales in the Middle-East. Full-year 2019 Lantus® sales decreased 17.0% to €3,012 million.
On January 28, 2020, Sanofi’s petition for rehearing the Court of Appeals for the Federal Circuit decision affirming the December 2018 PTAB decisions invalidating the Lantus® formulation patents was denied. Mylan currently does not have FDA approval for either its vial or pen product.

Fourth-quarter Toujeo® sales increased 8.5% to €234 million. In the U.S., fourth-quarter Toujeo® sales were €77 million, down 7.4% mainly reflecting lower average net price and the increased contribution to the coverage gap related to Medicare Part D. In Europe and Emerging Markets, fourth-quarter Toujeo® sales were €87 million (up 14.3%) and €48 million (up 48.4%), respectively. Full-year 2019 Toujeo® sales increased 3.2% to €883 million.

Fourth-quarter and full-year 2019 Amaryl® sales were €79 million (stable) and €334 million (down 2.1%), respectively. In China, the second wave of the nationwide VBP (volume-based procurement) program includes glimepiride in 2020 and Sanofi has opted not to bid with Amaryl®. In China, Amaryl® sales were €136 million (up 3.1%) in 2019. Sanofi expects sales of Amaryl® in China to decline significantly in 2020 due to the extended VBP program.

Fourth-quarter Apidra® sales decreased 2.2% to €88 million. Lower sales in the U.S. (down 47.1% to €10 million) offset growth in Emerging Markets (up 20.7% to €34 million). Full-year 2019 Apidra® sales were €344 million, down 3.6%.

Admelog® (insulin lispro injection) generated sales of €56 million (down 1.8%) in the fourth quarter. Admelog® sales in the U.S. were €52 million, down 7.4% due to the WAC price adjustment of -44% which took effect on July 1, 2019. Full-year 2019 Admelog® sales were €250 million versus €93 million in 2018. Sanofi expects lower Admelog® sales in 2020 due to the full-year impact of the U.S. WAC price adjustment.

Fourth-quarter and full-year 2019 Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) and Suliqua™ sales increased 41% (to €39 million) and 60% (to €122 million), respectively.

Established Rx Products

Net sales (€ million)Q4 2019 Change
at CER
2019 Change
at CER
Synvisc® /Synvisc-One®81