Paris, October 31, 2019
Sanofi Q3 well on track
Q3 2019 | Change | Change at CER | 9M 2019 | Change | Change at CER | |
IFRS net sales reported | €9,499m | +1.1% | -1.1% | €26,518m | +4.1% | +2.2% |
IFRS net income reported | €1,766m | -22.3% | - | €2,816m | -30.5%(2) | - |
IFRS EPS reported | €1.49 | -18.6% | - | €2.33 | -28.3%(2) | - |
Business net income(1) | €2,399m | +4.3% | +0.2% | €5,805m | +6.4% | +4.1% |
Business EPS(1) | €1.92 | +4.3% | 0.0% | €4.65 | +6.4% | +4.1% |
Third-quarter 2019 sales performance(3) led by Sanofi Genzyme and Emerging Markets
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Sanofi Chief Executive Officer, Paul Hudson, commented: “Since joining Sanofi only two months ago, I am increasingly excited about the strength of our businesses, our ability to develop transformative medicines and the diverse talent of our teams across the organization. Building on this foundation, Sanofi delivered a resilient underlying performance in the third quarter with strong sales in Specialty Care, largely driven by the continued outstanding performance of Dupixent®. I am encouraged by the organization’s early achievements in our efficiency initiatives, which will allow us to further drive innovation in our business. I’m looking forward to discussing Sanofi‘s strategic priorities at our Capital Markets Day in Cambridge, MA on December 10”. |
(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 8 for definitions). The consolidated income statement for Q3 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) including in Q2 2019 a €1.8 billion impairment charge mainly related to Eloctate®; (3) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8); (4) Constant Structure: Adjusted for divestment of European generics business and sales of Bioverativ products to SOBI; (5) See definition page 9; (6) 2018 business EPS was €5.47.
Investor Relations: (+) 33 1 53 77 45 45 - E-mail: IR@sanofi.com - Media Relations: (+) 33 1 53 77 46 46 - E-mail: MR@sanofi.com Website: www.sanofi.com Mobile app: SANOFI IR available on the App Store and Google Play |
2019 third-quarter and first nine months Sanofi sales
Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(7). |
In the third quarter of 2019, Company sales were €9,499 million, up 1.1% on a reported basis. Exchange rate movements had a positive effect of 2.2 percentage points mainly driven by the strength of the U.S. dollar which was partially offset by the negative impact from the Argentine Peso. At CER, Company sales decreased 1.1%.
First nine months Company sales reached €26,518 million, up 4.1% on a reported basis. Exchange rate movements had a favorable effect of 1.9 percentage points. At CER, Company sales were up 2.2%.
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Global Business Units
The table below presents sales by Global Business Unit (GBU). Please note that Emerging Markets sales for Specialty Care and Primary Care are included in the China & Emerging Markets GBU.
Net Sales by GBU (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER | ||
Sanofi Genzyme (Specialty Care)(a) | 2,359 | +19.5% | 6,670 | +23.5%(c) | ||
Primary Care(a) | 2,185 | -17.5%(d) | 6,751 | -16.7%(e) | ||
China & Emerging Markets(b) | 1,890 | +10.0% | 5,739 | +9.1% | ||
Total Pharmaceuticals | 6,434 | +1.5% | 19,160 | +2.1% | ||
Consumer Healthcare (CHC) | 1,136 | +0.4% | 3,535 | +0.7% | ||
Sanofi Pasteur (Vaccines) | 1,929 | -9.8% | 3,823 | +3.9% | ||
Total net sales | 9,499 | -1.1% | 26,518 | +2.2%(f) |
(a) Does not include China & Emerging Markets sales - see definition page 10; (b) Includes Emerging Markets sales for Primary Care and Specialty Care; (c) +19.2% at CS -Adjusted for Bioverativ acquisition and sales of Bioverativ products to SOBI – see page 5; (d) -12.7% at CS; (e) -11.6% at CS; (f) +3.2% at CS - Adjusted for Bioverativ and sales of Bioverativ products to SOBI and European Generics.
Global Franchises
The tables below present third-quarter and first nine months 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) | Q3 2019 | Change at CER | Developed Markets | Change at CER | Emerging Markets | Change at CER |
Specialty Care franchises | 2,654 | +19.8% | 2,359 | +19.5% | 295 | +21.9% |
Rare Disease | 774 | +6.5% | 637 | +2.8% | 137 | +24.2% |
Multiple Sclerosis | 551 | +2.1% | 534 | +2.2% | 17 | 0.0% |
Oncology | 424 | +9.2% | 297 | +7.4% | 127 | +13.5% |
Immunology | 619 | +140.1% | 610 | +138.8% | 9 | ns |
Rare Blood Disorder | 286 | -3.9%(1) | 281 | -5.7%(2) | 5 | ns |
Primary Care franchises | 3,780 | -8.3%(3) | 2,185 | -17.5%(4) | 1,595 | +7.9% |
Established Rx Products(5) | 2,371 | -7.3%(6) | 1,207 | -17.9%(7) | 1,164 | +6.9% |
Diabetes | 1,261 | -9.9% | 837 | -17.7% | 424 | +10.1% |
Cardiovascular | 148 | -10.6% | 141 | -12.2% | 7 | +40.0% |
Consumer Healthcare | 1,136 | +0.4% | 722 | -3.3% | 414 | +7.3% |
Vaccines | 1,929 | -9.8% | 1,448 | -15.2% | 481 | +10.7% |
Total net sales | 9,499 | -1.1%(8) | 6,714 | -5.1%(9) | 2,785 | +9.7% |
(1) +1.1% at CS- see page 5; (2) -0.7% at CS- see page 5; (3) -5.0% at CS; (4 )-12.7% at CS; (5) including Generics; (6) -1.8% at CS; (7) -8.9% at CS; (8) +0.5% at CS;
(9) -2.9% at CS
(7) See Appendix 8 for definitions of financial indicators.
Net sales by Franchise (€ million) | 9M 2019 | Change at CER | Developed Markets | Change at CER | Emerging Markets | Change at CER |
Specialty Care franchises | 7,601 | +24.2%(1) | 6,670 | +23.5% | 931 | +28.5% |
Rare Disease | 2,350 | +8.3% | 1,890 | +3.2% | 460 | +31.1% |
Multiple Sclerosis | 1,620 | +3.5% | 1,563 | +3.2% | 57 | +12.5% |
Oncology | 1,254 | +10.4% | 872 | +6.7% | 382 | +19.5% |
Immunology | 1,526 | +158.9% | 1,507 | +157.1% | 19 | ns |
Rare Blood Disorder | 851 | +33.0%(2) | 838 | +30.8%(3) | 13 | ns |
Primary Care franchises | 11,559 | -8.4%(4) | 6,751 | -16.7%(5) | 4,808 | +5.8% |
Established Rx Products(6) | 7,283 | -8.9%(7) | 3,789 | -18.3%(8) | 3,494 | +3.7% |
Diabetes | 3,845 | -7.9% | 2,551 | -15.6% | 1,294 | +11.2% |
Cardiovascular | 431 | -4.6% | 411 | -6.6% | 20 | +66.7% |
Consumer Healthcare | 3,535 | +0.7% | 2,308 | -1.7% | 1,227 | +5.2% |
Vaccines | 3,823 | +3.9% | 2,550 | -5.6% | 1,273 | +28.7% |
Total net sales | 26,518 | +2.2%(9) | 18,279 | -1.6%(10) | 8,239 | +11.1% |
(1) +20.4 % at CS- Adjusted for Bioverativ and sales of products to SOBI – see page 5; (2) +1.5% at CS- see page 5; (3) -0.1% at CS -see page 5; (4) -5.0% at CS;
(5) -11.6% at CS; (6) including Generics; (7) -3.4% at CS; (8) -9.2% at CS; (9) +3.2% at CS- Adjusted for Bioverativ and sales of Bioverativ products to SOBI and European Generics;(10) -0.1% at CS - Adjusted for Bioverativ and sales of Bioverativ products to SOBI and European Generics
Pharmaceuticals
Third-quarter Pharmaceutical sales were up 1.5% (up 4.1% at CS) to €6,434 million mainly driven by Dupixent® which was partially offset by Diabetes and Established Rx Products including the disposal of the European generics business at the end of third-quarter 2018. First nine months sales for Pharmaceuticals increased 2.1% (up 3.6% at CS) to €19,160 million.
Specialty Care franchises
Immunology franchise
Net sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Dupixent® | 570 | +142.2% | 1,395 | +160.6% |
Kevzara® | 49 | +118.2% | 131 | +142.3% |
Total Immunology | 619 | +140.1% | 1,526 | +158.9% |
Dupixent® (collaboration with Regeneron) generated sales of €570 million in the third quarter (up 142%). In the U.S., Dupixent® sales of €455 million (up 130%) were driven by continued growth in atopic dermatitis which benefited from launch in the adolescent age group (12 to 17 years of age) in mid-March, rapid uptake in asthma and launch in chronic rhinosinusitis with nasal polyposis (approved in the U.S. in June). Dupixent® U.S. NBRx and TRx were respectively up 15% and 21% sequentially. In Europe, third-quarter sales were €54 million (up 170%). In Rest of the World region, Dupixent® sales were €52 million (up 243%) mainly generated in Japan. Dupixent® is now launched in 30 countries, 7 of which have multiple indications launched. First nine months Dupixent® sales increased 161% to €1,395 million. Long term 76 week data was recently published in the Journal of the American Academy of Dermatology with a safety profile that was consistent with previous clinical trials and sustained efficacy. This data is supportive of continuous long term use of Dupixent®.
Kevzara® (collaboration with Regeneron) sales were €49 million (up 118%) in the third quarter, of which €33 million was in the U.S. (up 78%) reflecting increased adoption and category share. First nine months Kevzara® sales increased 142% to €131 million.
Multiple Sclerosis franchise
Net sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Aubagio® | 494 | +12.4% | 1,397 | +11.7% |
Lemtrada® | 57 | -42.4% | 223 | -28.4% |
Total Multiple Sclerosis | 551 | +2.1% | 1,620 | +3.5% |
Third-quarter Multiple Sclerosis (MS) sales increased 2.1% to €551 million, driven by double-digit growth of Aubagio® in the U.S. and Europe, partially offset by lower Lemtrada® sales. First nine months MS sales increased 3.5% to €1,620 million.
Third-quarter Aubagio® sales increased 12.4% to €494 million, supported by the U.S. performance (up 13.8% to €363 million) and Europe (up 10.8% to €103 million). First nine months Aubagio® sales increased 11.7% to €1,397 million.
Beginning January 1, 2020, Aubagio® will be excluded from the ESI National Preferred Formulary.
In the third quarter, Lemtrada® sales decreased 42.4% to €57 million due to lower U.S. sales (down 33.3% to €34 million) and European sales (down 60.5% to €15 million), reflecting increased global competition and the update to the EU label. First nine months Lemtrada® sales decreased 28.4% to €223 million.
On October 30, 2019, Sanofi entered into an agreement to settle, without any admission of liability or wrongdoing, the previously disclosed action initiated against Sanofi by the Trustee relating to Sanofi’s publicly-traded Contingent Value Rights. As part of the settlement agreement, Sanofi will pay a total of $315 million. The settlement agreement is subject to, among other things, final court approval
Oncology franchise
Net sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Jevtana® | 119 | +8.5% | 356 | +11.7% |
Thymoglobulin® | 90 | +18.7% | 265 | +17.8% |
Eloxatin® | 52 | +6.1% | 161 | +15.1% |
Mozobil® | 50 | +14.3% | 143 | +11.3% |
Taxotere® | 42 | -4.5% | 131 | +0.8% |
Zaltrap® | 26 | +13.6% | 71 | +2.9% |
Others | 45 | +4.8% | 127 | +1.7% |
Total Oncology | 424 | +9.2% | 1,254 | +10.4% |
Third-quarter Oncology sales increased 9.2% to €424 million driven by Emerging Markets (up 13.5% to €127 million) and the U.S. (up 9.7% to €152 million). First nine months Oncology sales increased 10.4% to €1,254 million.
Third-quarter Jevtana® sales increased 8.5% to €119 million driven by the U.S. and Japan. First nine months Jevtana® sales were up 11.7% to €356 million. In the third quarter, Thymoglobulin® sales increased 18.7% to €90 million, reflecting the performance in Emerging Markets. Over the period, Eloxatin® sales grew 6.1% to €52 million driven by China. First nine months sales of Thymoglobulin® and Eloxatin® increased 17.8% (to €265 million) and 15.1% (to €161 million), respectively.
Libtayo® (collaboration with Regeneron) was approved in the U.S. in September 2018 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. U.S. Libtayo® sales are reported by Regeneron. Libtayo® was approved in Brazil at the end of March and in Canada in April. In late June, Libtayo® was approved in the European Union for adult patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation and launched in July in the UK, Germany, and Austria. Ex-U.S. Libtayo® sales were €4 million in the third quarter.
Rare Disease franchise
Net sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Myozyme® / Lumizyme® | 226 | +7.7% | 680 | +9.8% |
Fabrazyme® | 202 | +3.7% | 598 | +6.4% |
Cerezyme® | 168 | +6.7% | 531 | +6.1% |
Aldurazyme® | 49 | 0.0% | 170 | +12.5% |
Cerdelga® | 53 | +26.8% | 151 | +27.8% |
Others Rare Disease | 76 | +2.8% | 220 | +0.5% |
Total Rare Disease | 774 | +6.5% | 2,350 | +8.3% |
In the third quarter, Rare Disease sales increased 6.5% to €774 million, driven by Emerging Markets (up 24.2% to €137 million). In the U.S., third-quarter Rare Disease sales grew 4.8% to €298 million. In Europe, over the period, sales increased 4.1% to €253 million. First nine months Rare Disease sales increased 8.3% to €2,350 million.
Third-quarter Gaucher (Cerezyme® and Cerdelga®) sales were up 10.7% to €221 million, supported by the increasing penetration of Cerdelga® in Europe and the U.S. and the sustained growth of Cerezyme® in Emerging Markets. Third-quarter Cerdelga® sales increased 26.8% to €53 million, with sales up 53.8% in Europe (to €19 million) and up 12.0% in the U.S. (to €30 million). First nine months Gaucher sales were €682 million, up 10.1%.
Third-quarter Pompe (Myozyme®/Lumizyme®) sales grew 7.7% to €226 million, supported by positive trends in naïve patient accruals. This performance was driven by the U.S. (up 8.3% to €81 million) and Emerging Markets (up 18.8% to €34 million). First nine months Myozyme®/Lumizyme® sales increased 9.8% to €680 million.
Third-quarter Fabry (Fabrazyme®) sales grew 3.7% to €202 million, driven by Emerging Markets (up 33.3% to €22 million) and Europe (up 7.0% to €46 million). Over the period, U.S. sales were stable at €105 million. First nine months Fabrazyme® sales were up 6.4% to €598 million.
Rare Blood Disorder franchise
Net sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Eloctate® | 162 | -20.2%* | 507 | +15.8%* |
Alprolix® | 104 | +12.5%** | 304 | +51.1%** |
Cablivi® | 20 | - | 40 | - |
Total Rare Blood Disorder | 286 | -3.9%*** | 851 | +33.0%*** |
*-17.6% at CS in Q3 2019 and -11.2% in 9M 2019 at CS - see footnotes 8 and 9; **+23.8% at CS in Q3 2019 and +13.9% at CS in 9M 2019 – see footnotes 8 and 9;
*** +1.1% at CS in Q3 2019 and +1.5% in 9M 2019 at CS - see footnotes 8 and 9
Bioverativ was consolidated in Sanofi’s Financial Statements from March 9, 2018. Third-quarter sales of the Rare Blood Disorder franchise were €286 million, up 1.1% at CS(8). Third-quarter U.S. sales were €214 million, down 5.6%. Non U.S. sales were €72 million with Japan as the primary contributor. First nine months sales of the Rare Blood Disorder franchise were €851 million, up 1.5% at CS(9).
Eloctate® sales were €162 million in the third quarter, down 17.6% at CS(8). In the U.S., sales of the product decreased 23.5% to €122 million, reflecting ongoing competitive pressure. In the Rest of the World region, third-quarter Eloctate® sales decreased 8.6% at CS(8) to €35 million. First nine months Eloctate® sales were €507 million, down 11.2% at CS(9).
Alprolix® sales were €104 million in the third quarter, up 23.8% at CS(8). In the U.S., sales of the product increased 17.5% to €79 million. In the Rest of the World region, Alprolix® sales increased 47.1% at CS(8) to €25 million due to growth in product sales to SOBI and Japan. First nine months Alprolix® sales were €304 million, up 13.9% at CS(9).
Cablivi® for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) generated third-quarter sales of €20 million. In the U.S., where Cablivi® was launched in April, sales were €13 million. In Europe, where the product is commercially available in Germany, Denmark, Austria, Belgium and the Netherlands, sales were €6 million. Cablivi® has a temporary license to be sold in France. First nine months Cablivi® sales were €40 million.
Primary Care franchises
Cardiovascular franchise
Net sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Praluent® | 61 | -11.8% | 183 | -0.6% |
Multaq® | 87 | -9.7% | 248 | -7.5% |
Total cardiovascular franchise | 148 | -10.6% | 431 | -4.6% |
Third-quarter Praluent® (collaboration with Regeneron) sales decreased 11.8% to €61 million, reflecting lower sales in the U.S. (down 31.7% to €29 million) which were impacted by significantly higher rebates. In Europe, Praluent® sales increased 4.5% to €22 million despite the suspension of sales in Germany in August following the Regional Court of Dusseldorf ruling in the ongoing patent litigation. First nine months Praluent® sales decreased 0.6% to €183 million. In August, the U.S. District Court for the District of Delaware ruled in favor of Sanofi and Regeneron in the ongoing Praluent® (alirocumab) patent litigation. The Court found as a matter of law that Amgen’s asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are invalid based on lack of enablement. U.S. payer coverage for Praluent® in 2020 is expected to be lower for insured lives across Medicare plans.
(8) 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.
(9) Growth comparing first nine months 2019 sales versus full first nine months 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) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Lantus® | 751 | -17.5% | 2,283 | -17.0% |
Toujeo® | 218 | 0.0% | 649 | +1.4% |
Total glargine | 969 | -14.1% | 2,932 | -13.5% |
Amaryl® | 84 | -8.0% | 255 | -2.7% |
Apidra® | 83 | -2.4% | 256 | -4.1% |
Admelog® | 51 | +84.6% | 194 | ns |
Soliqua® | 33 | +55.0% | 83 | +71.7% |
Insuman® | 19 | -4.8% | 62 | -5.9% |
Total Diabetes | 1,261 | -9.9% | 3,845 | -7.9% |
In the third quarter, global Diabetes sales decreased 9.9% to €1,261 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S. Third-quarter U.S. Diabetes sales were down 24.7% to €451 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. Third-quarter sales in Emerging Markets increased 10.1% to €424 million. Third-quarter sales in Europe decreased 3.0% to €295 million despite Toujeo® growth (up 18.3% to €84 million). First nine months global Diabetes sales decreased 7.9% to €3,845 million. Broad U.S. payer coverage for key Diabetes brands is expected to be largely maintained in 2020.
In the third quarter, Lantus® sales were €751 million, down 17.5%. In the U.S., Lantus® sales decreased 32.5% to €295 million, mainly reflecting lower average net price and the increased contribution to the coverage gap related to Medicare Part D. In Europe, third-quarter Lantus® sales were €140 million, down 13.0% due to biosimilar glargine competition and patients switching to Toujeo®. In Emerging Markets, third-quarter Lantus® sales were up 9.5% to €264 million. First nine months Lantus® sales decreased 17.0% to €2,283 million.
Third-quarter Toujeo® sales were stable at €218 million. In the U.S., third-quarter Toujeo® sales were €73 million, down 25.0% mainly reflecting lower average net price and the increased contribution to the coverage gap related to Medicare Part D. In Europe and Emerging Markets, third-quarter Toujeo® sales were €84 million (up 18.3%) and €43 million (up 26.5%), respectively. First nine months Toujeo® sales increased 1.4% to €649 million.
Third-quarter and first nine months Amaryl® sales were €84 million (down 8.0%) and €255 million (down 2.7%), respectively.
Third-quarter Apidra® sales decreased 2.4% to €83 million. Lower sales in the U.S. (down 35.3% to €11 million) offset growth in Emerging Markets (up 23.1% to €32 million). First nine months Apidra® sales were €256 million, down 4.1%.
Admelog® (insulin lispro injection) generated sales of €51 million (up 85%) in the third quarter. Admelog® sales in the U.S. were €47 million, up 80% versus the third quarter of 2018, but down 34% versus the second quarter of 2019 due to the WAC price adjustment of -44% which took effect on July 1. First nine months Admelog® sales were €194 million versus €36 million in the same period of 2018.
Third-quarter and first nine months Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) and Suliqua™ sales increased 55% (to €33 million) and 72% (to €83 million), respectively.
Established Rx Products
Net sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Lovenox® | 334 | -5.4% | 1,024 | -8.5% |
Plavix® | 356 | -0.6% | 1,122 | -0.4% |
Aprovel®/Avapro® | 169 | +5.7% | 543 | +7.2% |
Synvisc® /Synvisc-One® | 73 | -2.8% | 228 | -6.5% |
Renvela®/Renagel® | 84 | -28.9% | 229 | -29.8% |
Myslee®/Ambien®/Stilnox® | 56 | -1.8% | 163 | -8.1% |
Allegra® | 18 | -5.6% | 100 | -3.1% |
Generics | 268 | -32.1% | 804 | -33.9% |
Other | 1,013 | -1.2% | 3,070 | -3.3% |
Total Established Rx Products | 2,371 | -7.3% | 7,283 | -8.9% |
In the third quarter, Established Rx Products sales decreased 7.3% to €2,371 million, primarily reflecting the divestment of the European generics business Zentiva at the end of the third quarter of 2018. Excluding the generics divestment, Established Rx Products sales decreased 1.8% in the third quarter, reflecting generic competition to Renvela®/Renagel® (sevelamer) in the U.S. and lower Lovenox sales in Europe®. First nine months Established Rx Products sales decreased 8.9% to €7,283 million (down 3.4% at CS).
Third-quarter Lovenox® sales decreased 5.4% to €334 million, reflecting lower Mature Markets sales (down 16.2% to €191 million) due to biosimilar competition in several countries in Europe. In Emerging Markets, Lovenox® sales grew 14.6% to €143 million. First nine months Lovenox® sales were down 8.5% to €1,024 million.
In the third quarter, Plavix® sales decreased 0.6% to €356 million due to generic competition in Japan (sales down 23.1% to €32 million). In China, Plavix® sales increased 3.5% to €209 million despite the implementation of the volume based procurement program (VBP) in key cities in China at the beginning of the second quarter. First nine months Plavix® sales decreased 0.4% to €1,122 million.
Third-quarter Aprovel®/Avapro® sales increased 5.7% to €169 million driven by Emerging Markets sales (up 3.6% to €117 million). In China, Aprovel®/Avapro® sales were up 1.4% to €74 million despite the implementation of the VBP in key cities in China at the beginning of the second quarter. First nine months Aprovel®/Avapro® sales increased 7.2% to €543 million.
In September 2019, Plavix® and Co-Aprovel® were among the bidding winners of the nationwide VBP program. Sanofi expects the nationwide implementation of the VBP program to begin in December. As a result, Q4 2019 sales of Plavix® and Aprovel® family products are expected to decrease significantly due to net price adjustments of inventory in the channel. In 2020, Sanofi expects sales of Plavix® and the Aprovel® family in China to decline around 50%.
Third-quarter Renvela®/Renagel® (sevelamer) sales decreased 28.9% to €84 million, due to generic competition in the U.S. (down 50.7% to €39 million) and despite growth in China. First nine months Renvela®/Renagel® sales decreased 29.8% to €229 million.
In the third quarter, Generics sales decreased 32.1% to €268 million, reflecting the divestment of the European generics business Zentiva at the end of the third quarter of 2018. At CS, third-quarter Generics sales increased 7.9%, reflecting 6.8% growth in Emerging Markets (€176 million). First nine months Generics sales were €804 million, down 33.9% and up 5.4% at CS.
Consumer Healthcare
CHC sales by geography and category are provided in Appendix 1.
Net sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Allergy Cough & Cold | 287 | +1.4% | 898 | +2.3% |
of which Allegra® | 98 | +8.0% | 341 | +3.5% |
of which Mucosolvan® | 28 | -16.1% | 71 | -12.5% |
of which Xyzal® | 12 | +10.0% | 39 | +19.4% |
Pain | 300 | +3.8% | 930 | +2.6% |
of which Doliprane® | 73 | -2.7% | 229 | -3.0% |
of which Buscopan® | 41 | +14.6% | 139 | +7.6% |
Digestive | 229 | -4.7% | 777 | +4.7% |
of which Dulcolax® | 55 | +3.8% | 171 | +5.0% |
of which Enterogermina® | 54 | +26.2% | 169 | +23.5% |
of which Essentiale® | 42 | 0.0% | 141 | +8.5% |
of which Zantac® | 14 | -58.1% | 83 | -16.1% |
Nutritionals | 178 | +1.8% | 492 | -3.0% |
Other | 142 | -2.1% | 438 | -8.5% |
of which Gold Bond® | 49 | +2.1% | 149 | -2.1% |
Total Consumer Healthcare | 1,136 | +0.4% | 3,535 | +0.7% |
In the third quarter, Consumer Healthcare (CHC) sales increased 0.4% to €1,136 million, with growth coming from the Pain, Nutritionals, and Allergy, Cough & Cough categories, supported by performance in Emerging Markets (up 7.3% to €414 million). In the first nine months, CHC sales grew 0.7% to €3,535 million. Strengthening of regulatory requirements, particularly in Europe, as well as the continued effect of non-core divestments impacted growth in the third quarter. These factors are expected to have a dampening effect on CHC performance during the remainder of the year and through the first part of 2020. Additionally, in October Sanofi decided to conduct a precautionary voluntary recall of Zantac® in the U.S. and Canada. In September, 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 as the investigation continues. In the third quarter, Zantac® sales were down 58.1% to €14 million, reflecting the impact of this recall.
In Europe, third-quarter CHC sales decreased 7.0% to €306 million reflecting divestments of non-strategic brands and strengthening regulatory requirements. First nine months CHC sales in Europe were down 4.5% to €986 million.
In the U.S., third-quarter CHC sales decreased 4.4% to €252 million, reflecting the impact of the Zantac® recall. First nine months CHC sales in the U.S. were down 0.4% to €840 million.
In Emerging Markets, third-quarter CHC sales increased 7.3% to €414 million, driven by performance in Latin America. First nine months CHC sales in Emerging Markets increased 5.2% to €1,227 million.
Vaccines
Net sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
Influenza vaccines (incl. Vaxigrip®, Fluzone HD® & Fluzone®) | 735 | -28.5% | 852 | -25.9% |
Polio/Pertussis/Hib vaccines (incl. Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®) | 515 | -1.2% | 1,503 | +19.3% |
Meningitis/Pneumo vaccines (incl. Menactra®) | 310 | +8.8% | 558 | +12.3% |
Adult Booster vaccines (incl. Adacel ®) | 182 | +17.4% | 416 | +20.0% |
Travel and other endemic vaccines | 159 | +20.8% | 416 | +14.2% |
Other vaccines | 28 | +33.3% | 78 | +19.4% |
Total Vaccines | 1,929 | -9.8% | 3,823 | +3.9% |
Third-quarter Vaccines sales decreased 9.8% to €1,929 million. This anticipated decrease was impacted by the timing of flu vaccine delivery in the U.S. which will be significantly weighted towards the fourth quarter due to the roughly one-month delay in strain selection by the WHO at the beginning of the year. As a consequence, U.S. third-quarter Vaccines sales were down 19.5% to €1,122 million. In Emerging Markets and Europe, third-quarter Vaccines sales were up 10.7% (to €481 million) and up 7.8% (to €235 million), respectively. First nine months Vaccines sales were up 3.9% to €3,823 million.
In the third quarter, Polio/Pertussis/Hib (PPH) vaccines sales decreased 1.2% to €515 million, reflecting CDC inventory variation in the U.S. (down 37.8% to €78 million) which offset the strong performance in Emerging Markets (up 18.2% to €330 million). In Europe, PPH vaccines sales were stable at €73 million. First nine months PPH vaccines sales were up 19.3% to €1,503 million.
Influenza vaccines sales decreased 28.5% to €735 million in the third quarter, reflecting lower sales in the U.S. (down 32.6% to €580 million) due to the aforementioned delay in delivery. As already announced, Sanofi expects influenza vaccine sales to be significantly weighted towards the fourth quarter. First nine months influenza vaccines sales were down 25.9% to €852 million. Sanofi expects full-year 2019 influenza vaccines sales to exceed the prior year level, driven by its differentiated portfolio.
Third-quarter Menactra® sales increased 8.8% to €310 million, driven by the U.S. First nine months Menactra® sales increased 12.3% to €558 million.
Third-quarter Travel and other endemic vaccines sales were €159 million up 20.8%, supported by favorable phasing of yellow fever vaccine sales. First nine months Travel and other endemic vaccines sales were up 14.2% to €416 million.
Third-quarter Adult Booster vaccines sales were up 17.4% to €182 million, reflecting strong demand for Repevax® in Europe and favorable phasing for Adacel® in the U.S. First nine months Adult Booster vaccines sales increased 20.0% to €416 million.
Company sales by geographic region
Sanofi sales (€ million) | Q3 2019 | Change at CER | 9M 2019 | Change at CER |
United States | 3,671 | -4.5% | 9,072 | +2.4% |
Emerging Markets(a) | 2,785 | +9.7% | 8,239 | +11.1% |
of which Asia | 1,172 | +10.8% | 3,510 | +14.0% |
of which Latin America | 685 | +21.4% | 1,990 | +12.6% |
of which Africa, Middle East | 564 | -8.0% | 1,673 | +1.2% |
of which Eurasia(b) | 318 | +13.5% | 952 | +16.3% |
Europe(c) | 2,157 | -7.5% | 6,508 | -8.1% |
Rest of the World(d) | 886 | -1.7% | 2,699 | +3.5% |
of which Japan | 456 | +2.2% | 1,453 | +5.9% |
Total Sanofi sales | 9,499 | -1.1% | 26,518 | +2.2% |
Third-quarter sales in the U.S. decreased 4.5% to €3,671 million, reflecting the expected delay in flu vaccines supply which offset Dupixent® performance. In the U.S., first nine months sales increased 2.4% to €9,072 million.
Third-quarter sales in Emerging Markets grew 9.7% to €2,785 million, driven by Established Products (up 6.9%), Vaccines (up 10.7%), Diabetes (up 10.1%) and Rare Disease (up 24.2%). In Asia, third-quarter sales were up 10.8% to €1,172 million. In China, sales increased 13.7% to €744 million, driven by Pharmaceuticals and Vaccines. In Latin America, third-quarter sales increased 21.4% to €685 million. Third-quarter sales in Brazil were up 10.5% to €261 million. In Africa and the Middle East region, third-quarter sales were €564 million, down 8.0% reflecting order phasing in the Middle East. Third-quarter sales in the Eurasia region increased 13.5% to €318 million, supported by strong growth in Turkey. Third-quarter sales in Russia were €166 million up 9.0%. In Emerging Markets, first nine months sales increased 11.1% to €8,239 million.
Third-quarter sales in Europe were €2,157 million, down 7.5% reflecting divestment of the European generics business. At CS, third-quarter sales decreased 1.5% mainly reflecting lower Lovenox®, Lemtrada® and CHC sales which were partially offset by Dupixent® and Vaccines performance. In Europe, first nine months sales decreased 8.1% (-1.8% at CS) to €6,508 million.
Sales in Japan increased 2.2% to €456 million in the third quarter, driven by Dupixent® which largely offset lower sales of Plavix® due to generic competition. In Japan, first nine months sales increased 5.9% to €1,453 million.
R&D update
Consult Appendix 6 for full overview of Sanofi’s R&D pipeline |
Regulatory update
Regulatory updates since July 29, 2019 include the following:
At the end of October 2019, the R&D pipeline contained 85 projects, including 37 new molecular entities in clinical development (or that have been submitted to the regulatory authorities). 34 projects are in phase 3 or have been submitted to the regulatory authorities for approval.
Portfolio update
Phase 3:
Phase 2
Phase 1:
Collaboration
In September, Sanofi and Abbott announced a partnership to integrate glucose sensing and insulin delivery technologies that would help to further simplify how people with diabetes manage their condition.
Corporate Social Responsibility
Sanofi’s commitment to good corporate citizenship is rooted in its heritage. The company recognizes that its core business creates value for society, and it works to ensure that the benefits of this societal value are accessible to as many people around the world as possible. The company also has a longstanding commitment to the communities where it operates and to minimizing its impact on the environment.
Sanofi’s corporate social responsibility (CSR) approach was recognized during the third quarter of 2019 by the Dow Jones Sustainability Index (DJSI) for the 13th consecutive year. In 2019, Sanofi ranked as the third most sustainable pharmaceutical company with a score of 82 out of 100, up from 76 last year. The DJSI selects the best companies in each sector based on economic, social and environmental performance.
On October 15, 2019, Sanofi opened a digitally-enabled manufacturing facility in Framingham, one of the first of its kind, to develop transformative treatments for patients while significant reducing environmental waste. The facility will produce 80% less CO2 emissions compared to traditional technologies and reduce water and chemical usage by 91% and 94% respectively.
2019 third-quarter and first nine months financial results(10)
Business Net Income(10)
In the third quarter of 2019, Sanofi generated net sales of €9,499 million, an increase of 1.1% (down 1.1% at CER). First nine months sales were €26,518 million, up 4.1% on a reported basis (up 2.2% at CER).
Third-quarter other revenues increased 19.9% (up 14.8% at CER) to €422 million, reflecting the VaxServe sales contribution of non-Sanofi products (€372 million, up 18.7% at CER). First nine months other revenues increased 23.8% (up 17.2% at CER) to €1,096 million, driven by the VaxServe sales contribution of non-Sanofi products (€915 million, up 24.0% at CER) and the consolidation of collaboration revenues from Swedish Orphan Biovitrum AB (SOBI).
Third-quarter Gross Profit increased 0.9% to €6,787 million (down 1.8% at CER). The gross margin ratio decreased 0.2 percentage points to 71.4% (71.2% at CER) versus the third quarter of 2018. The favorable effects from Dupixent® and the divestment of the European generics business were more than offset by the negative impact from U.S. Diabetes net price evolution, the decline in Established Rx Products sales in Mature Markets as well as the impact of Vaccines and the Zantac® recall. In the third quarter of 2019, the gross margin ratio of segments were 74.8% for Pharmaceuticals (up 1.2 percentage points), 64.8% for CHC (down 2.0 percentage points) and 67.4% for Vaccines (down 2.7 percentage points). First nine months Gross Profit increased 5.1% to €19,095 million (up 2.8% at CER). In the first nine months of 2019, the gross margin ratio increased 0.7 percentage points to 72.0% (71.8% at CER) versus the same period of 2018. Sanofi expects its full-year 2019 gross margin ratio to be between 70% and 71% at CER.
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