Sanofi Q3 well on track

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

  • Net sales were €9,499 million, up 1.1% on a reported basis, down 1.1%(3) at CER and up 0.5% at CER/CS(4).
  • Sanofi Genzyme sales increased 19.5% driven by continued strong uptake of Dupixent®.
  • Vaccines sales decreased 9.8% reflecting anticipated weighting of U.S. flu vaccines supply towards fourth quarter.
  • CHC sales up 0.4%, impacted by Zantac® voluntary recall, non-core divestments and increased regulatory requirements.
  • Primary Care sales declined 12.7% at CER/CS due to lower sales in Diabetes and Established Products.
  • Emerging Markets(5) sales grew 9.7% due to strong performance in most regions.

Full-year business EPS guidance confirmed

  • Q3 2019 business net income increased 4.3% to €2,399 million and 0.2% at CER.
  • Q3 2019 business EPS(1) was stable at CER at €1.92.
  • Q3 2019 IFRS EPS was €1.49, down 18.6% reflecting the capital gain on the European generics divestment in Q3 2018.
  • Sanofi expects 2019 business EPS(1) to grow approximately 5% at CER(6) barring unforeseen major adverse events. Applying the average October 2019 exchange rates, the currency impact on 2019 business EPS is estimated to be around +3%.

Key R&D and regulatory milestones achieved

  • Dupixent® approved by European Commission for severe chronic rhinosinusitis with nasal polyposis.
  • Dupixent® approved by European Commission for adolescents with moderate-to-severe atopic dermatitis.
  • Dupixent® demonstrated positive topline phase 3 results in children aged 6 to 11 years with severe atopic dermatitis.
  • MenQuadfiTM, a meningococcal vaccine candidate, submitted in EU.
  • Flublok®, a quadrivalent influenza vaccine, submitted in EU.
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.comMedia 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%.

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 p

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