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).
Sec
Upcoming Life Sciences Events
- April 2024
- London: LSX World Congress
- May 2024
- Seoul: BIO KOREA 2024
- Biotechgate Digital Partnering May 2024