Press Releases

Sanofi H1 2020 business EPS(1) growth of 9.2%(2) driven by transformation

 Sanofi H1 2020 business EPS(1) growth of 9.2%(2) driven by transformation

Q2 2020 sales results reflect the strong performance of Dupixent® more than offset by COVID-19 related negative effects on Vaccines, General Medicines and CHC

  • Net sales were €8,207million, down 4.9% on a reported basis and a decline of 3.4%(2) at CER.
  • Specialty Care sales grew 17.4% driven by strong performance of Dupixent® (+70% to €858 million).
  • Vaccines sales (-6.8%) were affected by global confinements while in Southern Hemisphere demand for flu vaccines was strong.
  • General Medicines sales down 12.7% partly due to confinement related deferrals of elective procedures and channel destocking.
  • CHC sales declined 8.0% reflected unwinding of consumer stocking and lower pharmacy traffic as well as Zantac® voluntary recall.

Q2 2020 business EPS(1) benefits from share revaluation gain and effective cost management

  • Q2 2020 business net income increased 3.6% to €1,601 million and 5.6% at CER.
  • Q2 2020 business EPS(1) was €1.28, up 4.8% at CER (€1.18 excluding revaluation on retained Regeneron shares).
  • During the first half of 2020, cost savings of €990 million(3) were realized.
  • Q2 2020 IFRS EPS was €6.07, reflecting capital gain from sales of Regeneron shares.

R&D transformation, milestones and regulatory achievements

  • Dupixent® approved as the first biologic in China for moderate-to-severe atopic dermatitis in adults – first prescription on July 22.
  • Dupixent® approved for moderate-to-severe atopic dermatitis in children (6 to 11 years) in U.S. and positive CHMP opinion in EU.
  • Sarclisa® approved in EU for certain adults with relapsed and refractory multiple myeloma.
  • Pivotal IKEMA study evaluating Sarclisa® in relapsed multiple myeloma met primary endpoint at first planned interim analysis.
  • Libtayo® demonstrated clinically meaningful and durable responses in advanced basal cell carcinoma.
  • FDA granted priority review to sutimlimab in cold agglutinin disease.
  • Collaboration agreements with Translate Bio, Kiadis Pharma and Kymera Therapeutics.

Full-year 2020 business EPS(1) guidance revised upward
•     Sanofi now expects 2020 business EPS(1) to grow between 6% and 7%(4) at CER, barring unforeseen major adverse events. Applying average July 2020 exchange rates, the currency impact on 2020 business EPS is estimated to be between -3% to -4%.

Sanofi Chief Executive Officer, Paul Hudson, commented:

“I’m proud of what the team delivered in the second quarter. Even with some headwinds from the COVID-19 pandemic, we achieved business EPS growth supported by continued outstanding sales from Dupixent®, a focus on efficiency and smart spending, and the commitment of our people to patients and our strategic priorities. We also met important regulatory milestones, forged new R&D alliances, and accelerated our efforts to develop potential COVID-19 vaccines. With four new appointments, the management team at Sanofi is now complete and together we are focused on delivering our full-year 2020 guidance.”

Q2 2020 Change Change
at CER
H1 2020 Change Change
at CER
IFRS net sales reported €8,207m (4.9%) (3.4%) €17,180m +0.9% +1.6%
IFRS net income reported €7,598m €9,281m nm
IFRS EPS reported €6.07 €7.41 nm
Free cash flow(5) €2,010m +56.5% €3,568m +69.6%
Business operating income €2,146m +3.3% +5.3% €4,683m +8.8% +9.8%
Business net income(1) €1,601m +3.6% +5.6% €3,521m +8.7% +9.8%
Business EPS(1) €1.28 +3.2% +4.8% €2.81 +8.1% +9.2%

(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 Appendix10). The consolidated income statement for Q2 2020 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 10); (3) Including around €110M related to COVID-19​; (4) 2019 restated business EPS was €5.64, reflecting the discontinuation of equity method accounting for Regeneron investment; (5) Free cash flow is a non-GAAP financial measure (definition in Appendix 10).

2020 second-quarter and first-half Sanofi sales

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

In the second quarter of 2020, Company sales were €8,207 million, down 4.9% on a reported basis. Exchange rate movements had a negative effect of 1.5 percentage points, mainly driven by the decrease of the Brazilian real, Argentine peso and Mexican peso which offset the strength of the U.S. dollar and the Japanese yen. At CER, Company sales decreased 3.4%.

First-half Company sales reached €17,180 million, up 0.9% on a reported basis. Exchange rate movements had a negative effect of 0.7 percentage points. At CER, Company sales were up 1.6%.

Global Business Units

The tables below present second-quarter and first-half 2020 sales by Global Business Unit, including Consumer Healthcare, and by reporting region.

Net sales by GBU
(€ million)
Q2 2020 Change
at CER
U.S. Change
at CER
Europe Change
at CER
Rest of the
World
Change
at CER
Specialty Care 2,707  +17.4  % 1,709  +21.1  % 526  +8.6  % 472  +15.5  %
Dupixent 858 +70.0  % 697  +69.5  % 84 +84.8  % 77 +59.6  %
Multiple Sclerosis/
Neurology/Other I&I
608 +1.7  % 428 +2.9  % 135 -2.9  % 45 +4.4  %
Rare Disease 738 -0.5  % 283 —  % 232 -4.1  % 223  +2.5  %
Oncology 189 +18.2  % 90 +18.7  % 65 +20.4  % 34  +13.3  %
Rare Blood Disorder 314 +6.2  % 211 -6.4  % 10 +150.0  % 93  +38.8  %
General Medicines 3,549  -12.7  % 716  -16.5  % 1,012  -16.4  % 1,821  -9.1  %
Diabetes 1,194 -5.7  % 391 -17.4  % 293 -5.7  % 510  +4.7  %
Cardiovascular and Established Rx Products 2,355 -15.9  % 325 -15.5  % 719 -20.2  % 1,311  -13.5  %
Vaccines 927  -6.8  % 203  -40.9  % 128  -22.4  % 596  +20.4  %
Consumer Healthcare 1,024  -8.0  % 281  -5.2  % 297  -13.0  % 446  -6.2  %
Total net sales 8,207  -3.4  % 2,909  —  % 1,963  -10.8  % 3,335  -1.4  %
Net sales by GBU
(€ million)
H1 2020 Change
at CER
U.S. Change
at CER
Europe Change
at CER
Rest of the
World
Change
at CER
Specialty Care 5,402  +23.9  % 3,348  +28.3  % 1,115  +14.9  % 939  +21.0  %
Dupixent 1,634 +93.8  % 1,310  +91.0  % 174 +109.6  % 150 +101.4  %
Multiple Sclerosis/
Neurology/Other I&I
1,253 +7.3  % 874 +10.1  % 286 —  % 93 +6.8  %
Rare Disease 1,532 +5.2  % 563 +3.0  % 500 +2.9  % 469  +10.2  %
Oncology 375 +23.2  % 173 +19.0  % 136 +28.3  % 66  +24.1  %
Rare Blood Disorder 608 +5.0  % 428 -2.3  % 19 +111.1  % 161  +21.7  %
General Medicines 7,618  -8.2  % 1,458  -13.7  % 2,232  -7.6  % 3,928  -6.5  %
Diabetes 2,476 -3.4  % 766 -17.7  % 618 -0.5  % 1,092  +7.0  %
Cardiovascular and Established Rx Products 5,142 -10.3  % 692 -8.8  % 1,614 -10.0  % 2,836  -10.9  %
Vaccines 1,836  -2.0  % 491  -21.3  % 281  -11.4  % 1,064  +13.3  %
Consumer Healthcare 2,324  -1.6  % 583  -5.2  % 717  -2.8  % 1,024  +1.2  %
Total net sales 17,180  +1.6  % 5,880  +6.2  % 4,345  -2.1  % 6,955  +0.4  %

(6) See Appendix 11 for definitions of financial indicators.

Pharmaceuticals

Second-quarter 2020 Pharmaceutical sales were down 2.0% to €6,256 million, with double-digit growth of the Specialty Care portfolio mainly driven by the strong performance of Dupixent® more than offset by lower sales in General Medicines affected by COVID-19 related destocking, confinements and the VBP (volume-based procurement) program in China while the glargine business remained broadly stable. First-half sales for Pharmaceuticals increased 2.7% to €13,020 million.

Specialty Care GBU
Dupixent

 

Net sales (€ million) Q2 2020 Change
at CER
H1 2020 Change
at CER
Total Dupixent® 858  +70.0  % 1,634  +93.8  %


Dupixent
® (collaboration with Regeneron) generated sales of €858 million in the second quarter (up 70.0%). In the U.S., Dupixent® sales of €697 million (up 69.5%) were driven by continued growth in atopic dermatitis (AD) which benefited from increased penetration in adult and adolescent patients and the recent launch in children aged 6 to 11 years in the U.S. (approved in May 2020). Additional drivers were a rapid uptake in asthma and the launch in chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent® total prescriptions (TRx) almost doubled (+92% year-over-year) while new-to-brand prescriptions (NBRx) grew 11% and continued to reflect a modest slowdown due to confinements. Second-quarter sales of Dupixent® in Europe rose to €84 million (up 84.8%) reflecting continued growth in AD in key markets and additional launches. In Japan, sales were €45 million (up 31.3%), where good volume growth was moderated by the governmental price decrease implemented in April 2020. Dupixent® was approved in China for the treatment of adults with moderate-to-severe AD in June and first patients were treated on July 22. Dupixent® is now launched in 44 countries for adult atopic dermatitis; among these, Dupixent® is launched in adolescent AD in 18 countries, in pediatric AD in one country, in asthma in 18 countries and in CRSwNP in six countries. Potentially more than 50 additional country launches are planned across these indications by year end. First-half Dupixent® sales almost doubled (+93.8%) to €1,634 million.

Multiple Sclerosis/Neurology/Other Inflammation & Immunology

 

Net sales (€ million) Q2 2020 Change
 at CER
H1 2020 Change
 at CER
Aubagio® 527 +12.0  % 1,068 +16.5  %
Lemtrada® 19 -74.3  % 68 -59.0  %
Kevzara® 62 +17.3  % 117 +40.2  %
Total Multiple Sclerosis/ Neurology/Other I&I 608  +1.7  % 1,253  +7.3  %

Second-quarter and first-half Multiple Sclerosis/Neurology/Other I&I sales increased 1.7% to €608 million and 7.3% to €1,253 million, respectively.


Aubagio
® sales increased 12.0% in the second quarter to €527 million, driven both by the U.S. (up 11.9% to €384 million) and Europe (up 6.6% to €113 million) driven by price, demand and stocking at patient level. First-half Aubagio® sales increased 16.5% to €1,068 million.

In the second quarter, Lemtrada® sales decreased 74.3% to €19 million due to lower sales in the U.S. (-71.4%) and Europe (-78.3%), due to competition and likely further accelerated by the COVID-19 pandemic (route of administration, mode of action). First-half Lemtrada® sales were €68 million (-59.0%).


Kevzara
® (collaboration with Regeneron) sales were €62 million (up 17.3%) in the second quarter, of which €32 million were generated in the U.S. (up 6.7%) and €17 million in Europe (up 70.0%). First-half Kevzara® sales increased 40.2% to €117 million. On July 2, 2020 Sanofi and Regeneron announced that the U.S. Phase 3 trial of Kevzara® 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara® was added to best supportive care compared to best supportive care alone. Based on the results, the U.S. based trial was stopped. A separate Sanofi-led trial outside of the U.S. in hospitalized patients with severe and critical COVID-19 using a different dosing regimen is ongoing. The same Independent Data Monitoring Committee that is overseeing both the Regeneron-led U.S. trial and the Sanofi-led trial outside of U.S., has recommended that the trial outside the U.S. continues. Results from the ex-U.S. trial are expected in Q3 2020.

Rare Disease

Net sales (€ million) Q2 2020 Change
at CER
H1 2020 Change
at CER
Myozyme® / Lumizyme® 226 -2.6  % 472 +4.4  %
Fabrazyme® 199 -5.7  % 413 +3.8  %
Cerezyme® 179 +2.1  % 368 +5.8  %
Aldurazyme® 55 +3.7  % 122 +1.7  %
Cerdelga® 57 +12.0  % 115 +16.3  %
Others Rare Disease 22 +10.0% 42 +5.1%
Total Rare Disease 738  -0.5  % 1,532  +5.2  %

In the second quarter, Rare Disease sales slightly decreased 0.5% to €738 million reflecting the impact of the COVID-19 pandemic. Stable U.S. sales and a moderate growth in Rest of the World region were offset by lower sales in Europe. First-half Rare Disease sales increased 5.2% to €1,532 million.

Second-quarter Cerezyme® sales increased 2.1% to €179 million, driven by the Rest of the World region (up 13.8% to €77 million), reflecting favorable phasing in Brazil. Due to the COVID-19 pandemic, Cerezyme® sales were down both in Europe (-6.5% to €58 million) and U.S. (-6.7% to €44 million).

Second-quarter Cerdelga® sales increased 12.0% to €57 million, with sales up 16.7% in Europe (to €21 million) and 6.9% in the U.S. (to €32 million) driven by new patient accruals.

Second-quarter Myozyme®/Lumizyme® sales decreased 2.6% to €226 million due to lower sales in Europe (down 10.0% to €89 million) reflecting the COVID-19 pandemic. In the U.S., sales increased 7.2% to €91 million driven by new patient starts. In the Rest of the World, Myozyme®/Lumizyme® sales were down 3.9% to €46 million and reflected a high base for comparison. First-half Myozyme®/Lumizyme® sales increased 4.4% to €472 million.

Second-quarter Fabrazyme® sales decreased 5.7% to €199 million. In the U.S., second-quarter Fabrazyme® sales were down 4.8% to €102 million impacted by the COVID-19 pandemic. In the Rest of the World, second-quarter Fabrazyme® sales decreased 14.8% to €51 million, reflecting the high base for comparison and price reduction in Japan. In Europe, second-quarter Fabrazyme® sales increased 4.4% (to €46 million) as new patient starts more than offset COVID-19 impact. First-half Fabrazyme® sales were up 3.8% to €413 million.

Oncology

Net sales (€ million) Q2 2020 Change
at CER
H1 2020 Change
at CER
Jevtana® 133 +4.8  % 271 +13.1  %
Fasturtec® 37 +9.1  % 72 +9.2  %
Libtayo® 15 —  27 — 
Sarclisa® 4 —  5 — 
Total Oncology 189  +18.2  % 375  +23.2  %

Second-quarter and first-half Oncology sales increased 18.2% (to €189 million) and 23.2% (to €375 million), respectively, mainly reflecting Libtayo® launches outside the U.S. and growth from legacy franchises.

Second-quarter Jevtana® sales increased 4.8% to €133 million driven by the U.S. (up 14.8% to €63 million). Sales performance benefited from increased demand in metastatic castration-resistant prostate cancer following publication of the results of the CARD study in this disease setting at ESMO (European Society for Medical Oncology) and in the NEJM (New England Journal of Medicine) in September 2019. First-half Jevtana® sales increased 13.1% to €271 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 €15 million in the second quarter and €27 million in the first half of 2020. To date, Libtayo® has been launched in 16 countries outside the U.S. and up to 8 additional country launches are planned by the end of 2020. U.S. Libtayo® sales are reported by Regeneron.

The launch of Sarclisa® in the U.S. (approved in March in combination with pomalidomide and dexamethasone 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) was impacted by the COVID-19 environment. In June, the European Commission also approved Sarclisa® in certain adults with RRMM. In May 2020, the Phase 3 IKEMA trial evaluating Sarclisa® in combination with carfilzomib and dexamethasone in patients with relapsed multiple myeloma met the primary endpoint at its first planned interim analysis. These results will form the basis of regulatory submissions planned for later this year.

Rare Blood Disorder

Net sales (€ million) Q2 2020 Change
at CER
H1 2020 Change
at CER
Eloctate® 169 -2.9  % 330 -7.0  %
Alprolix® 117 +9.5  % 226 +10.5  %
Cablivi® 28 +86.7  % 52 +155.0  %
Total Rare Blood Disorder 314  +6.2  % 608  +5.0  %

In the second quarter, Rare Blood Disorder franchise sales were €314 million, up 6.2% driven by ex-U.S. sales and partly offset by a decline in the U.S. First-half sales of the Rare Blood Disorder franchise were €608 million, up 5.0%.

Eloctate
® sales were €169 million in the second quarter, down 2.9% due to lower U.S. sales (-16.3% to €115 million) as a result of ongoing competitive pressure. In the Rest of the World, Eloctate® sales increased 47.2% to €54 million reflecting increased sales to SOBI. First-half Eloctate® sales were €330 million (-7.0%).


Alprolix
® sales were €117 million in the second quarter, up 9.5%, driven mainly by sales in the Rest of the World (+25.8% to €39 million) reflecting increased sales to SOBI. In the U.S., Alprolix® sales increased 2.7%  to €78 million. First-half Alprolix® sales were €226 million, up 10.5%.

Cablivi
® for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) generated second-quarter and first-half sales of €28 million and €52 million, respectively. In Europe, the product is commercially available in several countries and has a temporary license to be sold in France.

General Medicines GBU

Diabetes

Net sales (€ million) Q2 2020 Change
at CER
H1 2020 Change
at CER
Lantus® 693 -7.0  % 1,417 -6.8  %
Toujeo® 239 +10.0  % 496 +15.3  %
Total glargine 932 -3.2  % 1,913 -1.9  %
Apidra® 84 +4.8  % 173 +2.9  %
Admelog® 44 -42.9  % 94 -35.7  %
Soliqua® 38 +35.7  % 75 +50.0  %
Other diabetes 96 -19.5  % 221 -11.8  %
Total Diabetes 1,194  <td style=”width:12.72%;;text-align: right ; vertical-align

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