31.10.2018 07:30:00 CET

Sanofi Q3 2018 Performance Confirms Return to Growth

Paris, October  31, 2018

Sanofi Q3 2018 Performance Confirms Return to Growth

  Q3 2018 Change Change
at CER
9M 2018 Change Change
at CER
IFRS net sales reported €9,392m +3.7% +6.3% €25,466m -3.5% +2.1%
IFRS net income reported €2,274m +45.7% - €4,052m -51.1%(2) -
IFRS EPS reported €1.82 +46.8% - €3.25 -50.7%(2) -
Business net income(1) €2,299m +7.6% +10.3% €5,455m -2.9% +4.2%
Business EPS(1) €1.84 +8.2% +11.2% €4.37 -2.0% +5.2%

Third-quarter sales(3) growth led by Specialty Care and Vaccines with strong support from Emerging Markets

  • Net sales were €9,392 million, an increase of 3.7% on a reported basis, 6.3%(3) at CER and 3.4% at CER/CS (4).
  • Sanofi Genzyme sales up 36.1% (14.9% at CER/CS(4)) driven by Immunology and Rare Blood Disorder franchises.
  • Vaccines delivered solid growth with sales up 8.2%, supported by the Pentaxim® recovery.
  • CHC sales increased 4.1% with growth across all geographies and key categories.
  • DCV(5) GBU sales were down 12.1%; Global Diabetes franchise sales declined 9.2%, with non-U.S. sales up 4.7%.
  • Emerging Markets sales(6) were up 10.4% supported by Vaccines and strong pharmaceutical growth in China.
Q3 2018 business EPS reflects beginning of new growth period

  • Third-quarter 2018 business EPS(1) up 11.2 % at CER to €1.84.
  • Third-quarter 2018 IFRS EPS was €1.82 (up 46.8%) reflecting €537 million of net capital gain related to EU generics.
  • Business operating income increased 6.4% at CER.
  • Business EPS(1) in 2018 now expected to grow 4% to 5% at CER(7) barring unforeseen major adverse events. Currency impact on 2018 Business EPS estimated to be around -6% applying the average October exchange rates.
Key achievements in sustaining innovation in R&D
  • Dupixent® approved in the U.S. for treatment of moderate-to-severe asthma.
  • Libtayo® approved in the U.S. for treatment of CSCC(8).
  • Cablivi® approved for aTTP(9) in EU and priority review granted in the U.S.
  • Praluent® ODYSSEY OUTCOMES results accepted for review by the FDA.
  • Dupixent® submitted to the FDA and the EMA for treatment of moderate-to-severe atopic dermatitis in adolescents.

Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"In the third quarter, Sanofi entered a new growth phase. We delivered strong results with double-digit growth in Specialty Care and Emerging Markets, while Vaccines contributed a high-single digit increase in sales. In addition, we are looking forward to expanding our Specialty Care business with the launches of Libtayo®, Cablivi® and Dupixent® for asthma. Based on the underlying dynamics demonstrated in the quarter, Sanofi is now well positioned to deliver growth".

(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 2018 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) Excluding Animal Health gain on disposal, first nine months IFRS net income was up 6.6% and first nine months IFRS EPS was up 7.6%; (3) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8); (4) Constant Structure: Adjusted for Bioverativ acquisition; (5) DCV: Diabetes and Cardiovascular; (6) See definition page 8; (7) 2017 business EPS was €5.52; (8) Cutaneous Squamous Cell Carcinoma; (9) Acquired thrombotic thrombocytopenic purpura.

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

2018 third-quarter and nine-months Sanofi sales

Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(10).

In the third quarter of 2018, Company sales were €9,392 million, up 3.7% on a reported basis. Exchange rate movements had a negative effect of 2.6 percentage points mainly driven by the movement of the Argentine Peso, Brazilian Real and Turkish Lira. At CER, Company sales increased 6.3%.

First nine months Company sales reached €25,466 million, down 3.5% on a reported basis. Exchange rate movements had an unfavorable effect of 5.6 percentage points. At CER, Company sales were up 2.1%.

Global Business Units

The table below presents sales by Global Business Unit (GBU). Please note that Emerging Markets sales for Specialty Care and Diabetes and Cardiovascular are included in the General Medicines and Emerging Markets GBU.

Net Sales by GBU
(€ million)
Q3 2018 Change
at CER
9M 2018 Change
at CER
Sanofi Genzyme (Specialty Care)(a)   1,904   +36.1% 5,172 +28.6%
Diabetes and Cardiovascular(a)   1,146   -12.1% 3,341 -14.5%
General Medicines & Emerging Markets(b)   3,160   +0.6% 9,896 -1.6%
Total Pharmaceuticals   6,210   +6.1% 18,409 +2.3%
Consumer Healthcare (CHC)   1,113   +4.1% 3,466 +3.3%
Sanofi Pasteur (Vaccines)   2,069   +8.2% 3,591 -0.3%
Total net sales   9,392   +6.3% 25,466 +2.1%

(a) Does not include Emerging Markets sales - see definition page 8; (b) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care


Global Franchises

The tables below present third-quarter and first nine months 2018 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 2018 Change
at CER
Developed
Markets
Change
at CER
Emerging
Markets
Change
at CER
Specialty Care 2,160 +34.6% 1,904 +36.1% 256 +26.3%
Diabetes and Cardiovascular 1,536 -6.3% 1,146 -12.1% 390 +14.2%
Established Rx Products 2,131 -3.2% 1,220 -9.1% 911 +5.5%
Consumer Healthcare (CHC) 1,113 +4.1% 731 +3.8% 382 +4.6%
Generics 383 -5.6% 222 -9.8% 161 0.0%
Vaccines 2,069 +8.2% 1,640 +5.4% 429 +19.8%
Total net sales 9,392 +6.3% 6,863 +4.7% 2,529 +10.4%

Net sales by Franchise
(€ million)
9M 2018 Change
at CER
Developed
Markets
Change
at CER
Emerging
Markets
Change
at CER
Specialty Care 5,941 +26.9% 5,172 +28.6% 769 +17.5%
Diabetes and Cardiovascular 4,531 -8.2% 3,341 -14.5% 1,190 +14.7%
Established Rx Products 6,717 -5.9% 3,848 -14.5% 2,869 +7.7%
Consumer Healthcare (CHC) 3,466 +3.3% 2,283 0.0% 1,183 +9.7%
Generics 1,220 -2.0% 708 -5.6% 512 +2.8%
Vaccines 3,591 -0.3% 2,593 +1.5% 998 -4.3%
Total net sales 25,466 +2.1% 17,945 -0.4% 7,521 +7.9%

(10) See Appendix 8 for definitions of financial indicators.

Pharmaceuticals

Third-quarter Pharmaceutical sales were up 6.1% to €6,210 million mainly driven by the Rare Blood Disorder and Immunology franchises which were partially offset by Diabetes and Established Rx Products. First nine months sales for Pharmaceuticals increased 2.3% to €18,409 million.

Rare Disease franchise

Net sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
Myozyme® / Lumizyme® 209 +13.7% 614 +10.8%
Fabrazyme® 191 +12.0% 549 +8.3%
Cerezyme® 165 +3.9% 521 +5.5%
Aldurazyme® 49 +8.0% 152 +3.8%
Cerdelga® 41 +32.3% 115 +30.1%
Others Rare Disease 71 -4.1% 213 -5.1%
Total Rare Disease 726 +9.3% 2,164 +7.4%

In the third quarter, Rare Disease delivered a solid performance with sales up 9.3% to €726 million, driven by Pompe, Gaucher and Fabry therapies. In the U.S. and Europe, third-quarter Rare Disease sales grew 7.9% (to €271 million) and 4.7% (to €244 million), respectively while Emerging Markets sales were up 28.1% to €124 million. First nine months Rare Disease sales increased 7.4% to €2,164 million.

Third-quarter Myozyme®/Lumizyme® sales grew 13.7% to €209 million, supported by positive trends in treatment naïve patient accruals. Third-quarter Myozyme®/Lumizyme® sales increased 14.3% to €72 million in the U.S. and 2.3% to €90 million in Europe, respectively. First nine months Myozyme®/Lumizyme® sales increased 10.8% to €614 million.

Third-quarter Gaucher (Cerezyme® and Cerdelga®) sales were up 8.1% to €206 million, supported by the increasing penetration of Cerdelga® in Europe and the sustained growth of Cerezyme® in Emerging Markets. Third-quarter Cerdelga® sales increased 32.3% to €41 million. First nine months Gaucher sales were €636 million, up 9.0%.

Third-quarter Fabrazyme® sales grew 12.0% to €191 million. Third-quarter sales in the U.S. and Europe increased 11.2% (to €100 million) and 10.0% (to €43 million), respectively. First nine months Fabrazyme® sales were up 8.3% to €549 million.

Multiple Sclerosis franchise

Net sales (€ million) Q3 2018 Change
 at CER
9M 2018 Change
 at CER
Aubagio® 426 +12.6% 1,201 +8.1%
Lemtrada® 99 -10.6% 306 -10.8%
Total Multiple Sclerosis 525 +7.3% 1,507 +3.7%

Third-quarter Multiple Sclerosis (MS) sales were up 7.3% to €525 million, as double-digit Aubagio® sales growth was partially offset by lower Lemtrada® sales. First nine months MS sales increased 3.7% to €1,507 million.

Third-quarter Aubagio® sales increased 12.6% to €426 million, driven by the U.S. (up 10.2% to €305 million) and Emerging Markets (up 125.0% to €13 million) performance. In Europe, sales were up 8.1% to €93 million. First nine months Aubagio® sales increased 8.1% to €1,201 million.

In the third quarter, Lemtrada® sales decreased 10.6% to €99 million due to lower U.S. sales (down 18.3% to €51 million) reflecting increased competition. In Europe, Lemtrada® sales were down 5.0% to €38 million. First nine months Lemtrada® sales decreased 10.8% to €306 million.

Immunology franchise

Net sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
Dupixent® 225 +198.7% 508 +428.7%
Kevzara® 22 ns 52 ns
Total Immunology 247 +218.2% 560 +465.4%

Dupixent® (collaboration with Regeneron) for the treatment of moderate-to-severe atopic dermatitis in adults generated sales of €225 million in the third quarter compared to €75 million in the third quarter of 2017. In the U.S., Dupixent® sales reached  €189 million in the third quarter (up 152.7%). Demand for the product remains strong with more than 63,000 patients having been prescribed to date and total prescriptions (source: IQVIA weekly TRx data) increasing 16% sequentially in the third quarter. Trade inventory in the third quarter is estimated to be steady at approximately four weeks. Dupixent was launched in 13 countries since its first approval and in four countries in the third quarter including the UK. Third-quarter sales in Europe were €20 million. First nine months Dupixent® sales were €508 million compared to €101 million in the same period of 2017. In October, Dupixent® was approved in the U.S. as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Kevzara® (collaboration with Regeneron) for rheumatoid arthritis generated sales of €22 million in the third-quarter, of which €18 million was in the U.S. reflecting improved commercial coverage. Kevzara® launched in new countries in the third quarter including Italy, France, Switzerland and Spain. First nine months Kevzara® sales were €52 million.

Rare Blood Disorder franchise

Net sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
Eloctate® 193 - 412 -
Alprolix® 88 - 190 -
Total Rare Blood Disorder 282 - 603 -

Bioverativ was consolidated in Sanofi's Financial Statements from March 9, 2018. Third-quarter sales of the Rare Blood Disorder franchise were €282 million (up 8.7% on a pro forma basis(11)), including non-U.S. sales of €66 million with Japan as the primary contributor. First nine months consolidated sales of the Rare Blood Disorder franchise were €603 million, up 15.1% on a pro forma basis(11).

Eloctate®, a recombinant antihemophilic Factor VIII, indicated for the treatment of hemophilia A, generated sales of €193 million in the third quarter, up 11.0% on a pro forma basis(11). This performance reflects continued share gains in moderate and severe hemophilia A patients in the U.S., Japan and Australia, partially offset by a decline in sales in Canada following tender loss. First nine months consolidated Eloctate® sales were €412 million, up 19.0% on a pro forma basis(11).

Alprolix®, a recombinant coagulation Factor IX, indicated for the treatment of hemophilia B, generated sales of €88 million in the third quarter, up 3.1% on a pro forma basis(11). First nine months consolidated Alprolix® sales were €190 million, up 7.0% on a pro forma basis(11).

In September, the European Commission granted marketing authorization for Cablivi® (caplacizumab) for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP). Cablivi® was recently launched in its first market, Germany.

Oncology franchise

Net sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
Jevtana® 106 +17.8% 308 +12.5%
Thymoglobulin® 75 +7.0% 219 +6.4%
Eloxatin® 49 +8.9% 139 +6.7%
Taxotere® 44 +2.3% 128 0.0%
Mozobil® 42 0.0% 124 +6.5%
Zaltrap® 22 +15.8% 68 +32.1%
Others 42 -22.6% 121 -38.9%
Total Oncology 380 +4.7% 1,107 +0.3%

 (11) Growth comparing full third-quarter 2018 sales versus full third-quarter 2017 sales, and full first nine months 2018 sales versus full first nine months 2017 sales at CER. Excluding the Sobi contract manufacturing sales. Unaudited data.

Third-quarter Oncology sales increased 4.7% to €380 million. Consistent with the Company's portfolio prioritization efforts, Sanofi sold Leukine® on January 31, 2018. Excluding Leukine®, Oncology third-quarter sales were up 6.7%. First nine months Oncology sales were up 0.3% to €1,107 million and up 5.1% excluding Leukine®.

Jevtana® sales were up 17.8% to €106 million in the third quarter supported by the performance in the U.S. (up 18.4% to €45 million). First nine months Jevtana® sales increased 12.5% to €308 million. In the third quarter, Thymoglobulin® and Eloxatin® sales increased 7.0% (to €75 million) and 8.9% (to €49 million), respectively, with growth driven by China. First nine months sales of Thymoglobulin® and Eloxatin® were up 6.4% (to €219 million) and up 6.7% (to €139 million), respectively.

In September, Libtayo® (cemiplimab-rwlc, collaboration with Regeneron) was approved in the U.S. 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. Libtayo® is the only treatment for advanced CSCC approved by the FDA.

Diabetes franchise

Net sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
Lantus® 897 -18.2% 2,699 -18.8%
Toujeo® 215 +10.7% 629 +10.7%
Total glargine 1,112 -13.9% 3,328 -14.6%
Amaryl® 88 +8.4% 258 +6.6%
Apidra® 85 +1.1% 268 +2.5%
Insuman® 21 -8.0% 68 -11.1%
Admelog® 26 - 36 -
Soliqua® 20 +150.0% 46 +188.2%
Total Diabetes 1,375 -9.2% 4,097 -10.4%

In the third quarter, global Diabetes sales decreased 9.2% to €1,375 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S. Third-quarter U.S. Diabetes sales were down 24.3% to €571 million, reflecting the previously announced changes in coverage of the Part D business and a continued decline in average U.S. glargine net prices. Third-quarter sales in Emerging Markets increased 13.4% to €385 million. Third-quarter sales in Europe decreased 2.2% to €304 million, supported by Toujeo® growth. First nine months global Diabetes sales decreased 10.4% to €4,097 million.

Third-quarter glargine (Lantus® and Toujeo®) sales decreased 13.9% to €1,112 million. U.S. glargine sales were down 29.3% to €511 million, reflecting the aforementioned changes in coverage in Part D and a continued decline in average U.S. glargine net prices. In Europe, glargine sales decreased 1.7% to €232 million reflecting strong Toujeo® performance. First nine months glargine sales decreased 14.6% to €3,328 million. In 2019, Sanofi expects Glargine to maintain broad payer coverage across Commercial and Medicare lives.

In the third quarter, Lantus® sales were €897 million, down 18.2%. In the U.S., Lantus® sales decreased 31.7% to €419 million, mainly reflecting lower average net price and changes in coverage in Part D. In Europe, third-quarter Lantus® sales were €161 million, down 12.0% due to biosimilar glargine competition and patients switching to Toujeo®. In Emerging Markets, third-quarter Lantus® sales were up 3.9% to €243 million. First nine months Lantus® sales decreased 18.8% to €2,699 million. Following Merck's decision not to commercialize insulin glargine in the U.S., and Merck's subsequent filing of motions to dismiss the U.S. pen and vial patent cases, Sanofi and Merck jointly filed stipulations on October 26 2018, asking the New Jersey and Delaware District Courts to dismiss the New Jersey and Delaware patent cases concerning Merck's proposed insulin glargine pen and vial products. On October 29, 2018, the Delaware Court ordered the dismissal and thus the Delaware pen patent case is now closed.

Third-quarter Toujeo® sales were €215 million, up 10.7%. In the U.S., third-quarter Toujeo® sales were €92 million, down 15.7%. In Europe and Emerging Markets, third-quarter Toujeo® sales were €71 million (up 33.3%) and €34 million (versus €17 million), respectively. First nine months Toujeo® sales increased 10.7% to €629 million.

Amaryl® sales were €88 million, up 8.4% in the third quarter, of which €76 million were generated in Emerging Markets (up 14.5%). First nine months Amaryl® sales were up 6.6% at €258 million.

Third-quarter Apidra® sales increased 1.1% to €85 million. Lower sales in the U.S. (down 19.0% to €17 million) were offset by strong growth in Emerging Markets (up 40.9% to €26 million). First nine months Apidra® sales increased 2.5% to €268 million.

Admelog® (insulin lispro injection) 100 Units/mL, which was launched in the U.S. in April, generated sales of €26 million in the third quarter mainly due to access in Managed Medicaid. First nine months Admelog® sales were €36 million.
Third-quarter and first nine months Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) and Suliqua(TM) sales were €20 million and €46 million, respectively.

Cardiovascular franchise

Net sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
Praluent® 68 +64.3% 179 +58.5%
Multaq® 93 +13.6% 255 +3.1%
Total cardiovascular franchise 161 +30.9% 434 +20.3%

Third-quarter Praluent® (collaboration with Regeneron) sales increased 64.3% to €68 million, of which €41 million was generated in the U.S. (up 46.4%) and €22 million in Europe (up 83.3%). First nine months Praluent® sales increased 58.5% to €179 million. The company continued to make progress in the third quarter with U.S. payers to simplify utilization management criteria (UM) in order to provide improved quality of access for patients in return for significantly higher rebates. As a result, around 39% of lives representing 52% of Praluent® sales in the Commercial channel now benefit from improved UM criteria.

Third-quarter and first nine months Multaq® sales were up 13.6% (to €93 million) and up 3.1% (to €255 million), respectively.

Established Rx Products

Net sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
Lovenox® 351 -0.3% 1,119 -1.1%
Plavix® 351 -0.3% 1,112 +3.0%
Aprovel®/Avapro® 158 +6.7% 501 -1.5%
Renvela®/Renagel® 114 -25.0% 315 -48.5%
Synvisc® /Synvisc-One® 72 -23.2% 232 -17.3%
Myslee®/Ambien®/Stilnox® 56 -9.5% 172 -8.5%
Allegra® 18 -25.0% 98 -16.7%
Other 1,011 -0.8% 3,168 -1.6%
Total Established Rx Products 2,131 -3.2% 6,717 -5.9%

In the third quarter, Established Rx Products sales decreased 3.2% to €2,131 million, reflecting lower U.S. sales of Renvela®/Renagel® (sevelamer) due to generic competition and competitive dynamic for Synvisc®. First nine months Established Rx Products sales decreased 5.9% to €6,717 million.

Third-quarter Lovenox® sales decreased 0.3% to €351 million, reflecting biosimilars competition in the UK, Poland Germany and Italy (sales in Europe were down 9.1% to €200 million), which offset growth in Emerging Markets (up 23.2% to €123 million). First nine months Lovenox® sales were down 1.1% to €1,119 million.

In the third quarter, Plavix® sales were down 0.3% to €351 million as result of generic competition in Japan (sales down 28.3% to €39 million) which offset good performance in Emerging Markets (up 5.5% to €262 million) driven by China. First nine months Plavix® sales increased 3.0% to €1,112 million.

Third-quarter Aprovel®/Avapro® sales increased 6.7% to €158 million, supported by strong performance in China. First nine months Aprovel®/Avapro® sales decreased 1.5% to €501 million.

Third-quarter Renvela®/Renagel® (sevelamer) sales decreased 25.0% to €114 million due to generic competition in the U.S. (down 33.9% to €75 million). First nine months Renvela®/Renagel® sales decreased 48.5% to €315 million.

Generics

In the third quarter, Generics sales decreased 5.6% to €383 million. Emerging Markets sales were stable at €161 million) while European sales were down 5.6% (to €169 million). Sanofi completed the previously-announced divestment of its European generics business Zentiva for €1.9 billion (enterprise value) to Advent International, effective September 30, 2018. This divestiture is consistent with Sanofi's strategy to simplify and reshape the company.

Consumer Healthcare

CHC sales by geography and category are provided in Appendix 1.

Net sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
Allergy Cough & Cold 276 +10.0% 856 -0.2%
   of which Allegra® 87 +3.4% 316 +2.4%
   of which Mucosolvan® 31 +3.2% 80 +9.1%
   of which Xyzal® 10 +42.9% 31 -41.4%
Pain 290 +2.9% 918 +7.4%
   of which Doliprane® 74 +4.2% 235 +4.4%
   of which Buscopan® 41 -6.8% 145 +21.8%
Digestive 234 +7.1% 730 +10.2%
   of which Dulcolax® 52 +3.8% 161 +9.7%
   of which Enterogermina® 42 +21.6% 136 +16.7%
   of which Essentiale® 40 +7.9% 129 +10.6%
   of which Zantac® 31 0.0% 93 +13.6%
Nutritionals 171 +5.9% 501 +3.3%
Other 142 -9.3% 461 -6.7%
   of which Gold Bond® 47 +2.2% 144 +6.9%
Total Consumer Healthcare 1,113 +4.1% 3,466 +3.3%

In the third quarter, Consumer Healthcare (CHC) sales increased 4.1% to €1,113 million, led by Emerging Markets (up 4.6%). In Europe and in the U.S., third quarter sales increased 3.4% and 2.9%, respectively. First nine months CHC sales increased 3.3% to €3,466 million.

In Europe, third-quarter CHC sales were up 3.4% to €329 million driven by Allergy Cough & Cold (up 11.3%) and Digestive (up 9.4%) categories. First nine months CHC sales in Europe increased 1.1% to €1,035 million.

In the U.S., third-quarter CHC sales increased 2.9% to €251 million supported by Allergy Cough & Cold (up 7.9%) and Pain (up 10.8%) categories. First nine months U.S. CHC sales decreased 3.1% to €792 million.

In Emerging Markets, third-quarter CHC sales increased 4.6% to €382 million driven by Allergy, Cough and Cold (up 17.6%) and Digestive (up 8.9%) categories. First nine months Emerging Markets CHC sales increased 9.7% to €1,183 million.

Vaccines

Net sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
Influenza vaccines
(incl. Vaxigrip®, Fluzone HD®, Fluzone®, Flublok®)
985 +2.8% 1,112 +2.6%
Polio/Pertussis/Hib vaccines
(incl. Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®)
511 +20.3% 1,245 -2.0%
Meningitis/Pneumo vaccines
(incl. Menactra®)
273 +7.9% 478 -8.1%
Adult Booster vaccines (incl. Adacel ®) 149 +4.2% 335 +3.0%
Travel and other endemic vaccines 130 +15.8% 358 +11.7%
Other vaccines 21 -8.7% 63 -19.3%
Total Vaccines 2,069 +8.2% 3,591 -0.3%

Third-quarter Vaccines sales were up 8.2% driven by the expected recovery in Pentaxim® supply in China and performance of Menactra® and Flublok®. In Emerging Markets, third-quarter Vaccines sales increased 19.8% to €429 million reflecting the recovery in China. In the U.S., third-quarter Vaccines sales were up 3.6%. In Europe, third-quarter Vaccines sales increased 10.1% driven by influenza and Travel and other endemic vaccines. In the second half of 2018, sales of the Vaccines GBU are expected to grow mid to high-single digits, supported by the growth of the Polio/Pertussis/Hib and Influenza franchises.

Third-quarter Influenza vaccines sales were up 2.8% to €985 million, despite expectations of slightly greater weighting of shipments towards the fourth-quarter versus the prior year. Influenza vaccines performance was driven by Vaxigrip® QIV in Europe and by the differentiated portfolio in the U.S. with Flublok® making a strong contribution. First nine months Influenza vaccines sales increased 2.6% to €1,112 million.

In the third quarter, Polio/Pertussis/Hib (PPH) vaccines sales were up 20.3% to €511 million, mainly reflecting the expected recovery in Pentaxim® supply in China. In the U.S., PPH vaccines sales increased 10.3% to €119 million driven by Pentacel®. In Europe, PPH vaccines sales decreased 2.7% to €74 million. First nine months Polio/Pertussis/Hib vaccines sales decreased 2.0% to €1,245 million.

Third-quarter Menactra® sales increased 8.8% to €273 million, of which €229 million were generated in the U.S. (up 7.1%). First nine months Menactra® sales were down 4.4% to €478 million reflecting CDC buying pattern.

Third-quarter Adult Booster vaccines sales increased 4.2% to €149 million driven by Adacel® in the U.S. and Emerging Markets. First nine months Adult Booster vaccines sales increased 3.0% to €335 million.

Third-quarter Travel and other endemic vaccines sales were €130 million up 15.8% supported by increased demand for Yellow fever and Hepatitis A. First nine months Travel and other endemic vaccines sales were up 11.7% to €358 million.

Company sales by geographic region

Sanofi sales (€ million) Q3 2018 Change
at CER
9M 2018 Change
at CER
United States 3,668 +5.5% 8,345 -1.8%
Emerging Markets(a) 2,529 +10.4% 7,521 +7.9%
  of which Asia 1,028 +10.3% 3,021 +9.6%
  of which Latin America 604 +12.6% 1,902 +10.1%
  of which Africa, Middle East 601 +8.1% 1,631 -0.2%
  of which Eurasia(b) 267 +8.9% 864 +12.5%
Europe(c) 2,334 +1.9% 7,092 +0.8%
Rest of the World(d) 861 +9.4% 2,508 +1.4%
  of which Japan 412 +6.2% 1,287 -2.2%
Total Sanofi sales 9,392 +6.3% 25,466 +2.1%
  1. World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico
  2. Russia, Ukraine, Georgia, Belarus, Armenia and Turkey
  3. Western Europe + Eastern Europe except Eurasia
  4. Japan, South Korea, Canada, Australia, New Zealand, Puerto Rico

Third-quarter sales in the U.S. were up 5.5% to €3,668 million. This reflects the strong performances of Dupixent® and Aubagio®, the consolidation of Eloctate® and Alprolix® sales, which were offset by lower sales in Diabetes (down 24.3%) and for sevelamer. In the U.S., first nine months sales decreased 1.8% to €8,345 million.

Third-quarter sales in Emerging Markets increased 10.4% to €2,529 million, mainly driven by Diabetes (up 13.4%), Rare Diseases (up 28.1%), Oncology (up 13.9%) and Vaccines (up 19.8%). In Asia, sales were up 10.3% to €1,028 million in the third quarter, reflecting the strong growth of the pharmaceutical and Vaccines businesses in China (up 17.7% to €644 million). In Latin America, third-quarter sales increased 12.6% to €604 million. Third-quarter sales in Brazil were up 4.1% to €228 million impacted by lower sales in Diabetes. In Africa and the Middle East region, third-quarter sales were €601 million, up 8.1%. Third-quarter sales in the Eurasia region increased 8.9% to €267 million, supported by strong growth in Turkey. Third-quarter sales in Russia were €145 million up 0.6%. In Emerging Markets, first nine months sales increased 7.9% to €7,521 million.

Third-quarter sales in Europe were €2,334 million, up 1.9% mainly due to Vaccines (up 10.1%) and the roll-out of Dupixent® and Praluent® which offset lower sales in Established Rx Products (down 2.9%). In Europe, first nine months sales increased 0.8% to €7,092 million.

Sales in Japan increased 6.2% to €412 million in the third quarter, driven by Vaccines and the Rare Blood Disorder franchise which offset the impact of Plavix®  generic competition. In Japan, first nine months sales decreased 2.2% to €1,287 million.

R&D update

Consult Appendix 6 for full overview of Sanofi's R&D pipeline

Regulatory update

Regulatory updates since July 31, 2018 include the following:

At the end of October 2018, the R&D pipeline contained 94 projects including 42 new molecular entities in clinical development. 40 projects are in phase 3 or have been submitted to the regulatory authorities for approval.

Portfolio update

Phase 3:

Phase 2:

Phase 1:

2018 third-quarter and first nine months financial results(12)

Business Net Income(12)

In the third quarter of 2018, Sanofi generated net sales of €9,392 million, an increase of 3.7% (up 6.3% at CER). First nine months sales were €25,466 million, down 3.5% on a reported basis (up 2.1% at CER).

Third-quarter other revenues increased 3.5% (up 2.6% at CER) to €352 million, reflecting the VaxServe sales contribution of non-Sanofi products (€300 million, up 10.8 % at CER) and the royalties received from Swedish Orphan Biovitrum AB. First nine months other revenues increased 3.0% (up 9.0% at CER) to €885 million of which €697 million were generated by VaxServe (up 16.2% at CER).

Third-quarter Gross Profit increased 2.8% to €6,727 million (up 4.8% at CER). The gross margin ratio was 71.6% (71.2% at CER) versus 72.3% in the third quarter of 2017. The positive mix impact of Specialty Care as well as the contribution from Bioverativ were more than offset by the negative impacts from U.S. Diabetes net price evolution and sevelamer generic competition, coupled with a slightly lower Vaccines gross margin ratio. In the third quarter of 2018, the gross margin ratio of segments was 73.6% for Pharmaceuticals (down 1.2 percentage points), 66.8% for CHC (down 0.2 percentage points) and 70.1% for Vaccines (down 0.4 percentage points). First nine months Gross Profit decreased 3.8% to €18,168 million (up 1.7% at CER). In the first nine months of 2018, the gross margin ratio decreased 0.3 percentage point to 71.3% (71.3% at CER) versus the same period of 2017. Sanofi expects its gross margin ratio to be between 70% and 71% at CER in 2018.

Research and Development (R&D) expenses increased 8.9% to €1,461 million in the third quarter of 2018. At CER, R&D expenses increased 9.5%, mainly reflecting the acquisitions of Bioverativ and Ablynx together with the investments in the immuno-oncology and diabetes programs. First nine months R&D expenses increased 5.2% to €4,216 million (up 9.1% at CER).

Third-quarter selling general and administrative expenses (SG&A) decreased 0.8% to €2,301 million. At CER, SG&A expenses were up 1.6% mainly reflecting consolidation of Bioverativ and Ablynx. Additional marketing investments in immunology and in China were offset by lower Diabetes expenses in the U.S. In the third quarter, the ratio of SG&A to sales decreased 1.1 percentage points to 24.5% compared to the third quarter of 2017. First nine months SG&A expenses decreased 3.6% to €7,110 million (up 1.7% at CER). In the first nine months of 2018, the ratio of SG&A to sales was stable at 27.9% compared to the same period of 2017.

Third-quarter other current operating income net of expenses was -€74 million versus €16 million in the third quarter of 2017 and included the share of profit/loss to Regeneron of the monoclonal antibodies Alliance net of associated marketing expenses incurred by Regeneron. In the third quarter of 2017, this line included €68 million of income related to a capital gain and a litigation settlement. First nine months other current operating income net of expenses was €84 million versus €118 million in the same period of 2017.

The share of profits from associates was €153 million in the third quarter versus €35 million for the same period of 2017. The majority of this increase from the year ago quarter is due to discrete items in the equity accounting treatment of our ownership in Regeneron, including adjustments related to IFRS versus U.S. GAAP and prior period true-up based on actual reported results.

(12) See Appendix 3 for 2018 third-quarter consolidated income statement; see Appendix 8 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income.

In the first nine months, the share of profits from associates was €302 million versus €105 million for the same period of 2017.

In the third quarter, non-controlling interests were -€26 million versus -€30 million in the third quarter of 2017. First nine months non-controlling interests were -€84 million versus -€95 million for the same period of 2017.

Third-quarter business operating income increased 3.9% to €3,018 million. At CER, business operating income increased 6.4%. The ratio of business operating income to net sales was stable at 32.1% versus the third quarter of 2017. Over the period, the business operating income ratio of segments was 35.6% for Pharmaceuticals (down 1.1 percentage points), 33.2% for CHC (down 2.2 percentage points) and 55.3% for Vaccines (up 0.7 percentage points). First nine months business operating income was €7,144 million, down 6.5% (or up 0.1% at CER). In the first nine months of 2018 the ratio of business operating income to net sales decreased by 0.9 percentage points to 28.1%.

Net financial expenses were -€106 million in the third quarter versus -€77 million in the same period of 2017. In the third quarter of 2018, net financial expenses included the cost associated with the Bioverativ and Ablynx acquisitions. First nine months net financial expenses were -€211 million versus -€200 million in the same period of 2017.

The third-quarter and the first nine months effective tax rate were 22.0% compared to 24.5% for the same periods of 2017.

Third-quarter business net income(12) increased 7.6% to €2,299 million and 10.3% at CER. The ratio of business net income to net sales increased 0.9 percentage points to 24.5% versus the third quarter of 2017. First nine months 2018 business net income(13) decreased 2.9% to €5,455 million and increased 4.2% at CER. The ratio of business net income to net sales increased 0.1 percentage points to 21.4% versus the same period of 2017.

In the third quarter of 2018, business earnings per share(12) (EPS) increased by 8.2% to €1.84 on a reported basis and by 11.2% at CER. The average number of shares outstanding was 1,247.1 million versus 1,254.3 million in the third quarter of 2017.

In the first nine month of 2018, business earnings per share(12) was €4.37, down 2.0% on a reported basis and up 5.2% at CER. The average number of shares outstanding was 1,247.6 million in the first nine months of 2018 versus 1,258.3 million in the first nine months of 2017.

Reconciliation of IFRS net income reported to business net income (see Appendix 4)

In the first nine months of 2018, the IFRS net income was €4,052 million. The main items excluded from the business net income were:

             

             

             
(12) See Appendix 3 for 2018 third-quarter consolidated income statement; see Appendix 8 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income.

             

Capital Allocation

In the first nine months of 2018, net cash generated by operating activities was €3,221 million after capital expenditures of €1,062 million and an increase in working capital of €1,927 million. This net cash flow funded restructuring costs and similar items (€683 million) and share repurchases (€955 million). Over the period, the dividend paid by Sanofi was €3,773 million and acquisitions and partnerships net of disposals were €10,968 million (including €12,686 million related to Bioverativ and Ablynx acquisitions and €1,577 million related to European generics business divestment). As a consequence, net debt increased from €5,161 million at December 31, 2017, to €18,705 million at September 30, 2018 (amount net of € 9,502 million in cash and cash equivalents).

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions, and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Appendices

List of appendices

Appendix 1:  2018 third-quarter and first nine months net sales by GBU, franchise, geographic region and product

 
Appendix 2: 2018 third-quarter and first nine months business net income statement

 
Appendix 3: 2018 third-quarter and first nine months consolidated income statement

 
Appendix 4: Reconciliation of IFRS net income reported to business net income

 
Appendix 5

 

Appendix 6:

 

Appendix 7:
Currency sensitivity

 

R&D pipeline

 

Expected R&D milestones
 

Appendix 8:
 

Definitions of non-GAAP financial indicators

Appendix 1: 2018 third-quarter net sales by GBU, franchise, geographic region and product

                 
Q3 2018
(€ million)
Total
GBUs
% CER % reported Europe % CER United States % CER Rest of the World % CER Emerging Markets % CER Total
Franchises
% CER % reported
Aubagio 413 10.2% 10.4% 93 8.1% 305 10.2% 15 21.4% 13 125.0% 426 12.6% 11.5%
Lemtrada 93 -13.1% -13.1% 38 -5.0% 51 -18.3% 4 -14.3% 6 33.3% 99 -10.6% -12.4%
Total MS 506 5.0% 5.2% 131 4.0% 356 5.1% 19 9.5% 19 85.7% 525 7.3% 6.1%
Cerezyme 118 -0.8% -0.8% 64 -5.9% 44 4.8% 10 11.1% 47 13.6% 165 3.9% -7.3%
Cerdelga 40 29.0% 29.0% 13 100.0% 25 8.7% 2 0.0% 1 - 41 32.3% 32.3%
Myozyme 177 6.7% 7.3% 90 2.3% 72 14.3% 15 0.0% 32 60.0% 209 13.7% 10.0%
Fabrazyme 173 8.9% 9.5% 43 10.0% 100 11.2% 30 0.0% 18 41.2% 191 12.0% 9.1%
Aldurazyme 34 2.9% 0.0% 18 0.0% 11 0.0% 5 16.7% 15 18.8% 49 8.0% -2.0%
Total Rare
Disease
602 5.1% 5.6% 244 4.7% 271 7.9% 87 -2.4% 124 28.1% 726 9.3% 4.0%
Taxotere 9 0.0% 0.0% 0 -100.0% 1 -200.0% 8 -11.1% 35 2.9% 44 2.3% 2.3%
Jevtana 99 15.3% 16.5% 39 11.4% 45 18.4% 15 16.7% 7 60.0% 106 17.8% 17.8%
Eloxatine 8 0.0% 0.0% 1 0.0% 0 -100.0% 7 16.7% 41 10.8% 49 8.9% 8.9%
Thymo-
globulin
56 1.9% 3.7% 9 -10.0% 41 10.8% 6 -28.6% 19 23.5% 75 7.0% 5.6%
Mozobil 40 0.0% 0.0% 11 0.0% 25 0.0% 4 0.0% 2 0.0% 42 0.0% -2.3%
Total
Oncology
269 1.1% 2.3% 86 3.6% 134 -0.7% 49 2.2% 111 13.9% 380 4.7% 4.4%
Dupixent 223 196.0% 197.3% 20 1900.0% 189 152.7% 14 - 2 - 225 198.7% 200.0%
Kevzara 22 950.0% 1000.0% 3 - 18 750.0% 1 - 0 - 22 950.0% 1000.0%
Total Immunology 245 215.6% 218.2% 23 - 207 168.4% 15 - 2 - 247 218.2% 220.8%
Alprolix 88 - - 0 - 63 - 25 - 0 - 88 - -
Eloctate 193 - - 0 - 153 - 40 - 0 - 193 - -
Total Hemophilia Rare blood disorders 282 - - 1 - 216 - 65 - 0 - 282 - -
Sanofi Genzyme (Specialty Care) 1,904 36.1% 36.9% 485 9.5% 1,184 47.4% 235 54.6% 256 26.3% 2,160 34.6% 32.2%
Lantus 654 -24.8% -24.7% 161 -12.0% 419 -31.7% 74 0.0% 243 3.9% 897 -18.2% -20.2%
Toujeo 181 0.0% 0.6% 71 33.3% 92 -15.7% 18 -5.6% 34 123.5% 215 10.7% 9.1%
Apidra 59 -11.9% -11.9% 32 -8.6% 17 -19.0% 10 -9.1% 26 40.9% 85 1.1% -4.5%
Amaryl 12 -21.4% -14.3% 5 0.0% 0 - 7 -33.3% 76 14.5% 88 8.4% 6.0%
Admelog 26 - - 3 - 25 - -2 - 0 - 26 - -
Total Diabetes 990 -16.4% -16.1% 304 -2.2% 571 -24.3% 115 -4.1% 385 13.4% 1,375 -9.2% -11.4%
Multaq 91 12.5% 13.8% 12 20.0% 79 16.4% 0 -100.0% 2 100.0% 93 13.6% 14.8%
Praluent 65 61.0% 58.5% 22 83.3% 41 46.4% 2 200.0% 3 200.0% 68 64.3% 61.9%
Total Cardio-
vascular
156 28.9% 28.9% 34 54.5% 120 25.3% 2 -25.0% 5 150.0% 161 30.9% 30.9%
Diabetes & Cardio-
vascular
1,146 -12.1% -11.9% 338 1.5% 691 -18.7% 117 -4.8% 390 14.2% 1,536 -6.3% -8.3%
Plavix 351 -0.3% -2.0% 34 -5.4% 0 - 55 -19.1% 262 5.5% 351 -0.3% -2.0%
Lovenox 351 -0.3% -4.9% 200 -9.1% 9 -40.0% 19 -4.5% 123 23.2% 351 -0.3% -4.9%
Renagel / Renvela 114 -25.0% -25.0% 14 -16.7% 75 -33.9% 8 -33.3% 17 46.2% 114 -25.0% -25.0%
Aprovel 158 6.7% 5.3% 26 -3.6% 2 0.0% 19 -5.9% 111 11.8% 158 6.7% 5.3%
Allegra 18 -25.0% -25.0% 2 100.0% 0 - 16 -30.4% 0 - 18 -25.0% -25.0%
Myslee / Ambien / Stilnox 56 -9.5% -11.1% 8 -20.0% 11 0.0% 23 -15.4% 14 0.0% 56 -9.5% -11.1%
Synvisc / Synvisc One 72 -23.2% -24.2% 5 -16.7% 51 -30.1% 3 50.0% 13 0.0% 72 -23.2% -24.2%
Depakine 113 4.5% 1.8% 40 -7.1% 0 - 2 33.3% 71 10.6% 113 4.5% 1.8%
Tritace 52 -1.8% -5.5% 34 -2.9% 0 - 2 0.0% 16 0.0% 52 -1.8% -5.5%
Other Rx Drugs 846 -1.3% -5.9% 431 1.9% 39 -17.4% 92 2.1% 284 -4.2% 846 -1.3% -5.9%
Total Esta-
blished Rx Products
2,131 -3.2% -6.4% 794 -2.9% 187 -28.4% 239 -9.4% 911 5.5% 2,131 -3.2% -6.4%
Generics 383 -5.6% -11.1% 169 -5.6% 31 -24.4% 22 -16.7% 161 0.0% 383 -5.6% -11.1%
Total Emerging Markets Specialty Care 256 26.3% 5.3% 0 - 0 - 19 85.7% 256 26.3% 256 0 0
Total Emerging Markets Diabetes & Cardio-
vascular
390 14.2% 4.3% 0   0   0   390 14.2% 0.0%    
General Medicines Emerging Markets 3,160 0.6% -4.9% 963 -3.4% 218 -27.8% 261 -10.0% 1,718 9.7% 2,514 -3.5% -7.1%
   
Total Pharma-
ceuticals
6,210 6.1% 3.2% 1,786 0.7% 2,093 7.0% 613 8.4% 1,718 9.7% 6,210 6.1% 3.2%
   
Allergy, Cough and Cold 276 10.0% 6.6% 89 11.3% 68 7.9% 28 -9.7% 91 17.6% 276 10.0% 6.6%
Pain 290 2.9% -5.8% 120 0.8% 42 10.8% 29 0.0% 99 3.3% 290 2.9% -5.8%
Digestive 234 7.1% 3.5% 69 9.4% 47 -2.1% 15 15.4% 103 8.9% 234 7.1% 3.5%
Nutri-
tional
171 5.9% 1.2% 30 20.0% 9 0.0% 71 15.9% 61 -6.9% 171 5.9% 1.2%
Consumer Healthcare 1,113 4.1% -1.0% 329 3.4% 251 2.9% 151 6.1% 382 4.6% 1,113 4.1% -1.0%
   
Polio / Pertussis / Hib 511 20.3% 18.0% 74 -2.7% 119 10.3% 43 53.6% 275 28.7% 511 20.3% 18.0%
Adult Booster Vaccines 149 4.2% 4.2% 30 -16.2% 100 7.6% 5 -16.7% 14 75.0% 149 4.2% 4.2%
Menin-
gitis/ Pneumonia
273 7.9% 8.3% 0 - 229 6.6% 4 -42.9% 40 28.1% 273 7.9% 8.3%
Influenza Vaccines 985 2.8% 3.6% 83 27.7% 818 0.6% 31 33.3% 53 -6.7% 985 2.8% 3.6%
Travel And Other Endemics Vaccines 130 15.8% 14.0% 31 47.6% 39 11.4% 13 7.7% 47 6.7% 130 15.8% 14.0%
Vaccines 2,069 8.2% 8.0% 219 10.1% 1,324 3.6% 97 22.5% 429 19.8% 2,069 8.2% 8.0%
Total Company 9,392 6.3% 3.7% 2,334 1.9% 3,668 5.5% 861 9.4% 2,529 10.4% 9,392 6.3% 3.7%
                           

2018 first nine-months net sales by GBU, franchise, geographic region and product

                 
First 9 months 2018
(€ million)
Total
GBUs
% CER % reported Europe % CER United States % CER Rest of the World % CER Emer-
ging Mar-
kets
% CER Total
Fran-
chi-
ses
% CER % reported
Aubagio 1,163 6.6% 1.0% 277 -4.5% 846 10.8% 40 2.4% 38 74.1% 1,201 8.1% 2.0%
Lemtrada 288 -13.0% -16.5% 130 -0.8% 144 -18.9% 14 -34.8% 18 35.3% 306 -10.8% -15.5%
Total MS 1,451 2.1% -3.0% 407 -3.3% 990 5.2% 54 -10.8% 56 59.1% 1,507 3.7% -2.1%
Cerezyme 354 -1.9% -5.1% 198 -3.9% 127 2.2% 29 -6.3% 167 21.1% 521 5.5% -4.9%
Cerdelga 113 28.0% 21.5% 35 100.0% 72 9.9% 6 25.0% 2 - 115 30.1% 23.7%
Myozyme 526 9.0% 5.4% 278 8.6% 205 11.1% 43 2.3% 88 21.2% 614 10.8% 5.1%
Fabrazyme 493 7.5% 2.3% 130 8.3% 279 7.6% 84 6.0% 56 15.0% 549 8.3% 1.3%
Aldurazyme 105 2.8% -0.9% 56 0.0% 32 6.3% 17 5.6% 47 5.6% 152 3.8% -5.0%
Total Rare Disease 1,772 5.0% 0.9% 746 6.1% 780 4.9% 246 2.0% 392 17.9% 2,164 7.4% 0.0%
Taxotere 26 -10.3% -10.3% 2 -33.3% 2 - 22 -15.4% 102 2.9% 128 0.0% -3.8%
Jevtana 290 13.1% 8.6% 117 6.4% 129 16.8% 44 21.1% 18 5.0% 308 12.5% 7.3%
Eloxatine 24 0.0% -4.0% 2 -33.3% 0 -100.0% 22 9.5% 115 8.2% 139 6.7% 3.0%
Thymoglobulin 163 1.2% -4.1% 28 -6.7% 119 4.9% 16 -11.1% 56 24.5% 219 6.4% 0.0%
Mozobil 117 5.1% 0.0% 35 6.1% 70 1.4% 12 30.0% 7 33.3% 124 6.5% 0.8%
Total Oncology 789 -3.3% -7.3% 262 1.9% 382 -11.0% 145 13.7% 318 10.1% 1,107 0.3% -4.4%
Dupixent 505 425.7% 400.0% 46 4500.0% 435 360.0% 24 - 3 - 508 428.7% 403.0%
Kevzara 52 1700.0% 1633.3% 8 - 41 1333.3% 3 - 0 - 52 1700.0% 1633.3%
Total Immunology 557 462.5% 435.6% 54 - 476 388.3% 27 - 3 - 560 465.4% 438.5%
Alprolix 190 - - 0 - 146 - 44 - 0 - 190 - -
Eloctate 412 - - 0 - 340 - 72 - 0 - 412 - -
Total Hemophilia Rare blood disorders 603 - - 1 - 486 - 116 - 0 - 603 - -
Sanofi Genzyme (Specialty Care) 5,172 28.6% 22.9% 1,470 6.3% 3,114 40.0% 588 36.8% 769 17.5% 5,941 26.9% 19.6%
Lantus 1,964 -25.3% -29.2% 516 -10.2% 1,235 -32.2% 213 -5.4% 735 4.5% 2,699 -18.8% -24.0%
Toujeo 530 1.1% -2.9% 213 39.0% 263 -18.0% 54 17.0% 99 107.4% 629 10.7% 4.8%
Apidra 188 -7.6% -10.5% 102 0.0% 57 -19.5% 29 -3.2% 80 32.9% 268 2.5% -4.3%
Amaryl 36 -17.8% -20.0% 13 -18.8% 1 0.0% 22 -17.9% 222 11.8% 258 6.6% 0.8%
Admelog 36 - - 5 - 32 - -1 - 0 - 36 - -
Total Diabetes 2,919 -17.9% -21.7% 952 -0.9% 1,630 -27.1% 337 -2.4% 1,178 14.3% 4,097 -10.4% -15.8%
Multaq 250 2.7% -2.7% 33 3.1% 214 3.6% 3 -50.0% 5 20.0% 255 3.1% -2.7%
Praluent 172 55.7% 49.6% 63 103.2% 102 33.3% 7 166.7% 7 166.7% 179 58.5% 51.7%
Total Cardio-
vascular
422 19.1% 13.4% 96 52.4% 316 11.6% 10 42.9% 12 75.0% 434 20.3% 14.2%
Diabetes & Cardio-
vascular
3,341 -14.5% -18.6% 1,048 2.3% 1,946 -22.7% 347 -1.6% 1,190 14.7% 4,531 -8.2% -13.6%
Plavix 1,112 3.0% -0.9% 110 -3.5% 0 - 165 -23.5% 837 11.7% 1,112 3.0% -0.9%
Lovenox 1,119 -1.1% -5.6% 671 -6.5% 29 -29.5% 60 -4.4% 359 14.1% 1,119 -1.1% -5.6%
Renagel / Renvela 315 -48.5% -51.2% 46 -14.5% 196 -60.4% 23 -17.9% 50 54.3% 315 -48.5% -51.2%
Aprovel 501 -1.5% -5.8% 81 -6.8% 7 -11.1% 60 -43.5% 353 14.1% 501 -1.5% -5.8%
Allegra 98 -16.7% -22.2% 7 0.0% 0 - 91 -17.6% 0 - 98 -16.7% -22.2%
Myslee / Ambien / Stilnox 172 -8.5% -14.0% 28 -6.7% 33 -10.0% 65 -16.9% 46 6.4% 172 -8.5% -14.0%
Synvisc / Synvisc One 232 -17.3% -22.9% 18 -21.7% 162 -24.7% 10 0.0% 42 27.0% 232 -17.3% -22.9%
Depakine 343 6.6% 2.4% 124 -0.8% 0 - 9 0.0% 210 11.6% 343 6.6% 2.4%
Tritace 167 -2.2% -6.7% 107 -5.3% 0 - 4 33.3% 56 1.6% 167 -2.2% -6.7%
Other Rx Drugs 2,658 -2.5% -7.7% 1,321 -1.2% 139 -6.9% 282 -8.0% 916 -1.9% 2,658 -2.5% -7.7%
Total Esta-
blished Rx Products
6,717 -5.9% -10.5% 2,513 -3.6% 566 -40.1% 769 -17.1% 2,869 7.7% 6,717 -5.9% -10.5%
Generics 1,220 -2.0% -8.8% 536 -5.0% 79 -22.7% 93 11.4% 512 2.8% 1,220 -2.0% -8.8%
Total Emerging Markets Specialty Care 769 17.5% 1.5% 0 - 0 - 56 59.1% 769 17.5% 769    
Total Emerging Markets Diabetes & Cardio-
vascular
1,190 14.7% 4.1%             1,190 14.7%      
General Medicines & Emerging Markets 9,896 -1.6% -7.9% 3,049 -3.9% 645 -38.4% 862 -14.8% 5,340 10.1% 7,937 -5.3% -10.2%
   
Total Pharmaceuticals 18,409 2.3% -3.4% 5,567 -0.2% 5,705 -1.5% 1,797 0.1% 5,340 10.1% 18,409 2.3% -3.4%
   
Allergy, Cough and Cold 856 -0.2% -6.8% 256 4.5% 241 -13.8% 106 0.9% 253 11.0% 856 -0.2% -6.8%
Pain 918 7.4% -1.5% 374 1.1% 120 1.6% 86 3.4% 338 17.3% 918 7.4% -1.5%
Digestive 730 10.2% 3.7% 232 3.6% 142 7.7% 42 9.8% 314 16.6% 730 10.2% 3.7%
Nutritional 501 3.3% -3.8% 92 7.0% 27 -6.5% 194 6.7% 188 0.0% 501 3.3% -3.8%
Consumer Healthcare 3,466 3.3% -4.0% 1,035 1.1% 792 -3.1% 456 3.6% 1,183 9.7% 3,466 3.3% -4.0%
   
Polio / Pertussis / Hib 1,245 -2.0% -6.7% 213 -0.5% 295 -3.4% 124 17.1% 613 -5.0% 1,245 -2.0% -6.7%
Adult Booster Vaccines 335 3.0% -0.6% 96 16.9% 197 -3.3% 18 0.0% 24 13.6% 335 3.0% -0.6%
Meningitis / Pneumonia 478 -8.1% -11.8% 0 -100.0% 386 -7.4% 11 -58.6% 81 7.5% 478 -8.1% -11.8%
Influenza Vaccines 1,112 2.6% 2.3% 84 29.2% 822 0.9% 55 34.9% 151 -7.5% 1,112 2.6% 2.3%
Travel And Other Endemics Vaccines 358 11.7% 7.5% 90 40.6% 101 0.0% 41 7.3% 126 8.2% 358 11.7% 7.5%
Vaccines 3,591 -0.3% -3.4% 490 13.4% 1,848 -2.0% 255 7.6% 998 -4.3% 3,591 -0.3% -3.4%
Total Company 25,466 2.1% -3.5% 7,092 0.8% 8,345 -1.8% 2,508 1.4% 7,521 7.9% 25,466 2.1% -3.5%

Appendix 2: Business net income statement

Third Quarter 2018 Pharmaceuticals Consumer Healthcare Vaccines Others(2) Total Group
€ million Q3 2018 Q3 2017(1) Cha-
nge
Q3 2018 Q3 2017(1) Cha-
nge
Q3  2018 Q3 2017(1) Cha-
nge
Q3 2018 Q3 2017(1) Cha-
nge
Q3 2018 Q3 2017(1) Cha-
nge
Net sales 6 ,210 6 ,016 3 .2 % 1 ,113 1 ,124 (1 .0) % 2 ,069 1 ,916 8 .0 % - -   9 ,392 9 ,056 3 .7 %
Other revenues 51 73 (30 .1) % - -   301 268 12 .3 % - (1) (100 .0) % 352 340 3 .5 %
Cost of Sales (1 ,688) (1 ,587) 6 .4 % (370) (371) (0 .3) % (920) (834) 10 .3 % (39) (61) (36 .1) % (3 ,017) (2 ,853) 5 .7 %
As  % of net sales (27 .2) % (26 .4) %   (33 .2) % (33 .0) %   (44 .5) % (43 .5) %         (32 .1) % (31 .5) %  
Gross Profit 4 ,573 4 ,502 1 .6 % 743 753 (1 .3) % 1 ,450 1 ,350 7 .4 % (39) (62)   6 ,727 6 ,543 2 .8 %
As  % of net sales 73 .6 % 74 .8 %   66 .8 % 67 .0 %   70 .1 % 70 .5 %         71 .6 % 72 .3 %  
Research and development expenses (1 ,148) (990) 16 .0 % (37) (30) 23 .3 % (125) (131) (4 .6) % (151) (190) (20 .5) % (1 ,461) (1 ,341) 8 .9 %
As  % of net sales (18 .5) % (16 .5) %   (3 .3) % (2 .7) %   (6 .0) % (6 .8) %         (15 .6) % (14 .8) %  
Selling and general expenses (1 ,298) (1 ,319) (1 .6) % (337) (359) (6 .1) % (174) (168) 3 .6 % (492) (473) 4 .0 % (2 ,301) (2 ,319) (0 .8) %
As  % of net sales (20 .9) % (21 .9) %   (30 .3) % (31 .9) %   (8 .4) % (8 .8) %         (24 .5) % (25 .6) %  
Other current operating income/ expenses (46) 12   3 35   (3) (8)   (28) (23)   (74) 16  
Share of profit/loss of associates* and joint-ventures 155 32   1 -   (3) 3   - -   153 35  
Net income attributable to non controlling interests (23) (30)   (3) (1)   - 1   - -   (26) (30)  
Business operating income 2 ,213 2 ,207 0 .3 % 370 398 (7 .0) % 1 ,145 1 ,047 9 .4 % (710) (748) (5 .1) % 3 ,018 2 ,904 3 .9 %
As  % of net sales 35 .6 % 36 .7 %   33 .2 % 35 .4 %   55 .3 % 54 .6 %         32 .1 % 32 .1 %  
                               
              Financial income and expenses (106) (77)  
              Income tax expenses   (613) (691)  
              Tax rate**   22 .0 % 24 .5 %  
              Business net income   2 ,299 2 ,136 7 .6 %
              As  % of net sales   24 .5 % 23 .6 %  
                       
              Business earnings / share (in euros)*** 1 .84 1 .70 8 .2 %

* Net of tax.
** Determined on the basis of Business income before tax, associates, and non-controlling interests.
*** Based on an average number of shares outstanding of 1,247.1 million in the third quarter of 2018 and 1,254.3 million in the third quarter of 2017.
(1) Includes the effects of first-time application of IFRS 15 on revenue recognition, effective January 1, 2018.
(2) Others include the cost of Global Support Functions (Medical Affairs, External Affairs, Finance, Human Resources, Information Solution & Technologies, Sanofi Business Services, etc.).

Nine Months 2018 Pharmaceuticals Consumer Healthcare Vaccines Others (2) Total Group
€ million 9M
2018
9M
2017  (1)
Cha-
nge
9M
2018
9M
2017  (1)
Cha-
nge
9M
2018
9M
2017  (1)
Cha-
nge
9M
2018
9M
2017  (1)
Cha-
nge
9M
2018
9M
2017  (1)
Cha-
nge
Net sales 18  ,409 19  ,054 (3   .4) % 3  ,466 3  ,610 (4  .0) % 3  ,591 3  ,716 (3  .4) % - -   25  ,466 26  ,380 (3  .5) %
Other revenues 185 221 (16   .3) % - -   700 638 9  .7 % - -   885 859 3  .0 %
Cost of Sales (4  ,918) (5  ,006) (1   .8) % (1  ,133) (1  ,189) (4  .7) % (1  ,988) (1  ,957) 1  .6 % (144) (196) (26  .5) % (8  ,183) (8  ,348) (2  .0) %
As  % of net sales (26  .7) % (26  .3) %   (32  .7) % (32  .9) %   (55  .4) % (52  .7) %         (32  .1) % (31  .6) %  
Gross Profit 13  ,676 14  ,269 (4   .2) % 2  ,333 2  ,421 (3  .6) % 2  ,303 2  ,397 (3  .9) % (144) (196)   18  ,168 18  ,891 (3  .8) %
As  % of net sales 74  .3 % 74  .9 %   67  .3 % 67  .1 %   64  .1 % 64  .5 %         71  .3 % 71  .6 %  
Research and deve-
lopment expen-
ses
(3  ,261) (2  ,989) 9   .1 % (95) (82) 15  .9 % (393) (391) 0  .5 % (467) (546) (14  .5) % (4  ,216) (4  ,008) 5  .2 %
As  % of net sales (17  .7) % (15  .7) %   (2  .7) % (2  .3) %   (10  .9) % (10  .5) %         (16  .6) % (15  .2) %  
Selling and general expen-
ses
(3  ,946) (4  ,126) (4   .4) % (1  ,125) (1  ,239) (9  .2) % (500) (531) (5  .8) % (1  ,539) (1  ,477) 4  .2 % (7  ,110) (7  ,373) (3  .6) %
As  % of net sales (21  .4) % (21  .7) %   (32  .5) % (34  .3) %   (13  .9) % (14  .3) %         (27  .9) % (27  .9) %  
Other current operating income/ expenses 86 53   85 92   (3) (7)   (84) (20)   84 118  
Share of profit/ loss of associates* and joint-ventures 305 103   1 -   (4) 2   - -   302 105  
Net income attributable to non controlling interests (75) (84)   (9) (12)   - 1   - -   (84) (95)  
Business operating income 6  ,785 7  ,226 (6   .1) % 1  ,190 1  ,180 0  .8 % 1  ,403 1  ,471 (4  .6) % (2  ,234) (2  ,239) (0  .2) % 7  ,144 7  ,638 (6  .5) %
As  % of net sales 36  .9 % 37  .9 %   34  .3 % 32  .7 %   39  .1 % 39  .6 %         28  .1 % 29  .0 %  
                               
              Financial income and expenses (211) (200)  
              Income tax expenses       (1  ,478) (1  ,820)  
              Tax rate**   22  .0 % 24  .5 %  
              Business net income   5  ,455 5  ,618 (2  .9) %
              As  % of net sales   21  .4 % 21  .3 %  
                               
              Business earnings / share  (in euros)*** 4  .37 4  .46 (2  .0) %

* Net of tax.
** Determined on the basis of Business income before tax, associates, and non-controlling interests.
*** Based on an average number of shares outstanding of 1,247.6 million in the nine first months of 2018 and 1,258.3 million in the nine first months of 2017.
(1) Includes the effects of first-time application of IFRS 15 on revenue recognition, effective January 1, 2018.
(2) Others include the cost of Global Support Functions (Medical Affairs, External Affairs, Finance, Human Resources, Information Solution & Technologies, Sanofi Business Services, etc.).

Appendix 3: Consolidated income statements

€ million Q3 2018 Q3 2017 (1) 9M 2018 9M 2017 (1)
 
Net sales 9,392  9,056 25,466  26,380
Other revenues 352 340 885 859
Cost of sales (3,032) (2,853) (8,297) (8,524)
Gross profit 6,712 6,543 18,054 18,715
Research and development expenses (1,461) (1,341) (4,216) (4,008)
Selling and general expenses (2,310) (2,319) (7,129) (7,373)
Other operating income 78 54 401 227
Other operating expenses (152) (38) (317) (109)
Amortization of intangible assets (537) (434) (1,536) (1,424)
Impairment of intangible assets (191) (19) (292) (31)
Fair value remeasurement of contingent consideration 107 (74) 117 (174)
Restructuring costs and similar items (108) (249) (715) (613)
Other gains and losses, and litigation 576 (147) 509 (154)
Operating income 2,714 1,976 4,876 5,056
Financial expenses (130)  

(103)
(332)  

(321)
Financial income 24 26 121 121
Income before tax and associates and joint ventures 2,608 1,899 4,665 4,856
Income tax expense (427) (411) (724) (1,023)
Share of profit/(loss) of associates and joint ventures 123 37 198 64
Net income excluding the exchanged/held-for-exchange Animal Health business 2,304 1,525 4,139 3,897
Net income/(loss) of the exchanged/held-for-exchange Animal Health business(2) (4) 63 (4) 4,484
Net income 2,300 1,588 4,135 8,381
Net income attributable to non-controlling interests 26 27 83 91
Net income attributable to equity holders of Sanofi 2,274 1,561 4,052 8,290
Average number of shares outstanding (million) 1,247.1 1,254.3 1,247.6 1,258.3
Earnings per share excluding the exchanged/held-for-exchange Animal Health business (in euros) 1.83 1.19 3.25 3.02
IFRS Earnings per share (in euros) 1.82 1.24 3.25 6.59

(1) Includes the effects of first-time application of IFRS 15 on revenue recognition, effective January 1, 2018.
(2) In 2017, net gain resulting from the divestment of the Animal Health business presented separately in accordance with IFRS 5, Non current assets held-for-sale and discontinued operations.

Appendix 4: Reconciliation of Net income attributable to equity holders of Sanofi to Business net income

€ million Q3 2018   Q3 2017(1)   Change
Net income attributable to equity holders of Sanofi 2,274   1,561   45.7%
Amortization of intangible assets(2) 537   434    
Impairment of intangible assets 191   19    
Fair value remeasurement of contingent consideration (107)   74    
Expenses arising from the impact of acquisitions on inventories 15   -    
Other expenses related to business combinations 9   -    
Restructuring costs and similar items 108   249    
Other gains and losses, and litigation (3) (576)   147    
Tax effect of the items listed above: (147)   (280)    
Amortization and impairment of intangible assets (176)   (128)    
Fair value remeasurement of contingent consideration 24   (2)    
Expenses arising from the impact of acquisitions on inventories (4)   -    
Restructuring costs and similar items (32)   (90)    
Other tax effects 41   (60)    
Other tax items(4) (39)   -    
Share of items listed above attributable to non-controlling interests -   (3)    
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures 30   (2)    
Animal Health items (5) 4   (63)    
Business net income 2,299   2,136   7.6%
IFRS earnings per share (6) (in euros) 1.82   1.24    

(1)   Includes the effects of first-time application of IFRS 15 on revenue recognition, effective January 1, 2018.
(2)  Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations:  €505 million in the third quarter   of 2018 and €400 million in the third quarter of 2017.
(3)  In 2018, separation costs for the European Generics business divestiture.
(4)  In 2018, adjustments made to our preliminary analysis of the direct and indirect impacts of US tax reform.
(5)  In 2017, net gain resulting from the divestment of the Animal Health business presented separately in accordance with IFRS 5, Non current assets held-for-sale and discontinued operations.
(6)  Based on an average number of shares outstanding of 1,247.1 million in the third quarter of 2018 and 1,254.3 million in the third quarter of 2017.

€ million 9M 2018   9M 2017(1)   Change
Net income attributable to equity holders of Sanofi 4,052   8,290   (51.1)%
Amortization of intangible assets(2) 1,536   1,424    
Impairment of intangible assets 292   31    
Fair value remeasurement of contingent consideration (117)   174    
Expenses arising from the impact of acquisitions on inventories 114   176    
Other expenses related to business combinations 19   -    
Restructuring costs and similar items 715   613    
Other gains and losses, and litigation (3) (509)   154    
Tax effect of the items listed above: (622)   (908)    
Amortization and impairment of intangible assets (451)   (477)    
Fair value remeasurement of contingent consideration 35   (33)    
Expenses arising from the impact of acquisitions on inventories (27)   (56)    
Restructuring costs and similar items (215)   (216)    
Other tax effects 36   (126)    
Other tax items(4) (132)   111    
Share of items listed above attributable to non-controlling interests (1)   (4)    
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures 104   41    
Animal Health items (5) 4   (4,484)    
Business net income 5,455   5,618   (2.9)%
IFRS earnings per share (6) (in euros) 3.25   6.59    

(1)   Includes the effects of first-time application of IFRS 15 on revenue recognition, effective January 1, 2018.
(2)  Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations:  €1,437 million in the nine first months of 2018 and €1,319 million in the nine first months of 2017.
(3)  In 2018, separation costs for the European Generics business divestiture.
(4)  In 2018, adjustments made to our preliminary analysis of the direct and indirect impacts of US tax reform. In 2017, relates to French 3% tax on dividends.
(5)  In 2017, net gain resulting from the divestment of the Animal Health business presented separately in accordance with IFRS 5, Non current assets held-for-sale and discontinued operations.
(6)  Based on an average number of shares outstanding of 1,247.6 million in the nine first months of 2018 and 1,258.3 million in the nine first months of 2017.

Appendix 5 : currency sensitivity

2018 Business EPS currency sensitivity

Currency Variation Business EPS Sensitivity
U.S. Dollar +0.05 USD/EUR -EUR 0.10
Japanese Yen +5 JPY/EUR -EUR 0.01
Chinese Yuan +0.2 CNY/EUR -EUR 0.02
Brazilian Real +0.4 BRL/EUR -EUR 0.02
Russian Ruble +10 RUB/EUR -EUR 0.03

Currency exposure on Q3 2018 sales

Currency Q3 2018
US $ 40.1%
Euro € 22.2%
Chinese Yuan 6.8%
Japanese Yen 4.2%
Brazilian Real 2.3%
British Pound 2.0%
Mexican Peso 1.7%
Canadian $ 1.5%
Russian Ruble 1.4%
Australian $ 1.4%
Others 16.4%

Currency average rates

  Q3 2017 Q3 2018 Change
€/$ 1.17 1.16 -0.9%
€/Yen 130.38 129.66 -0.6%
€/Yuan 7.84 7.92 +1.1%
€/Real 3.71 4.60 +24.0%
€/Ruble 69.28 76.28 +10.1%

Appendix 6: R&D Pipeline

: Opt-in rights products for which rights have not been exercised yet
: Registrational Study (other than Phase 3)

  Immuno-inflammation   Rare Blood Disorders   Cardiovascular & metabolism
  Oncology   MS & Neuro   Vaccines
  Rare Diseases   Diabetes    

New Molecular Entities(*)

Phase 1
(Total : 19)
Phase 2
(Total : 12)
Phase 3
(Total : 8)
Registration
(Total : 3)
SAR439794
TLR4 agonist
Peanut Allergy
BIVV001(3)
rFVIIIFc - vWF - XTEN(4)
Hemophilia A
SAR440340(**)
Anti-IL33 mAb
Asthma
SAR422459
ABCA4 gene therapy
Stargardt Disease
isatuximab
Anti-CD38 mAb
3L Relapsing Refractory MM (ICARIA)
cemiplimab(**)
PD-1 inhibitor mAb
Advanced CSCC (EU)
SAR408701
Maytansin-loaded anti-CEACAM5 mAb Solid Tumors
ST400(5)
ZFN Gene Editing Technology
Beta thalassemia
SAR156597
 IL4/IL13 bispecific mAb
Systemic Scleroderma
SAR425899
GLP-1/GCG dual agonist
Obesity/Overweight in T2D
avalglucosidase alfa
Neo GAA
Pompe Disease
ZynquistaTM(**)
Oral SGLT-1&2 inhibitor
Type 1 Diabetes (U.S./EU)
SAR439459
anti-TGFb  mAb
Advanced Solid Tumors
UshStat®
Myosin 7A gene therapy
Usher Syndrome 1B
GZ389988
TRKA antagonist
Osteoarthritis
SAR407899
rho kinase
Microvascular Angina
venglustat
Oral GCS inhibitor
ADPKD(12)
Cablivi®
Bivalent anti-vWF Nanobody
acquired Thrombotic Thrombocytopenic Purpura (U.S.)

O

REGN3767(1)
Anti-LAG-3 mAb
Advanced Cancers
SAR442168(6)(**)
BTK inhibitor
Multiple Sclerosis
Combination
ferroquine / OZ439(8)(**)
 Antimalarial
HIV
Viral vector prime & rgp120 boost vaccine
fitusiran
RNAi therapeutic targeting anti-thrombin
Hemophilia A and B
 
 

O

REGN4659(1)
Anti-CTLA-4 mAb
Cancer
SAR228810
Anti-protofibrillar AB mAb
Alzheimer's Disease
ALX0171
Anti RSV Nanobody
Respiratory Syncitial Virus
SP0232(11)(**)
Respiratory syncytial virus
Monoclonal Antibody
sutimlimab(13)
Anti Complement C1s mAb
Cold Agglutinin Disease
 
 

O

REGN4018(1)
Anti-MUC16-CD3 bispecific mAb
Ovarian Cancer
SAR438335
GLP-1/GIP dual agonist
Type 2 Diabetes

R

olipudase alfa
rhASM
Acid Sphingomyelinase Deficiency(9
  SAR341402
Rapid acting insulin
Type 1/2 Diabetes
 
   
SAR439859
SERD
Metastatic Breast Cancer
SAR440181(7)(**)
 
Myosin activation
Dilated Cardiomyopathy

O

SAR339375(10)
miRNA-21
Alport Syndrome
  efpeglenatide(**)
Long-acting GLP-1 agonist
Type 2 Diabetes
 
 
SAR442720(2)
SHP2 inhibitor
Solid Tumors
SAR247799
S1P1 agonist
Cardiovascular indication
    mavacamten(14)(**)
Myosin inhibitor - Obstructive Hypertrophic Cardiomyopathy
 
SAR440234
T cell engaging multi spe mAb
Leukemia
Herpes Simplex Virus Type 2
HSV-2 vaccine
       
  Respiratory syncytial virus
Infants
Vaccines
       

  1. Regeneron product for which Sanofi has opt-in rights
  2. Developed in collaboration with REVOLUTION Medicines; also know as RMC-4630
  3. Sanofi Product for which Sobi has opt-in rights
  4. Recombinant Coagulation Factor VIII Fc - von Willebrand Factor - XTEN Fusion protein
  5. Developed in collaboration with Sangamo
  6. Also known as PRN2246
  7. Also known as MYK491
  8. Developed in collaboration with MMV
  9. Also known as Niemann Pick type B
  10. Regulus product for which Sanofi has opt-in rights
 
  1. Also known as MEDI8897
  2. Autosomal Dominant Polycystic Kidney Disease
  3. Also Known as BIVV009
  4. Also known as SAR439152 and MYK461 
(*)      Phase of projects determined by clinicaltrials.gov disclosure timing
(**)    Partnered and/or in collaboration - Sanofi may have limited or shared rights on some 
of  these products

Additional Indications(*)

Phase 1
(Total : 6)
Phase 2
(Total : 17)
Phase 3
(Total : 23)
Registration
(Total : 6)
SAR439459 + cemiplimab(**)
Anti-TGFb mAb + PD-1 inhibitor mAb
Advanced Solid Tumors
dupilumab(**)
Anti-IL4Ralpha mAb
 Grass Immunotherapy
venglustat
Oral GCS inhibitor
Gaucher Type 3
dupilumab(**)
Anti-IL4Ralpha mAb
Asthma 6 - 11 years old
isatuximab
Anti-CD38 mAb
Newly Diagnosed MM Te
dupilumab(**)
Anti-IL4Ralpha mAb
Asthma 12y+ (EU)

O


cemiplimab(**) + REGN3767(1)

PD-1 inhibitor mAb + Anti-LAG-3 mAb
Advanced Cancers

R

sarilumab(**)
Anti-IL6R mAb
Polyarticular Juvenile Idiopathic Arthritis
venglustat
Oral GCS inhibitor
Fabry Disease
dupilumab(**)
Anti-IL4Ralpha mAb
Nasal Polyposis
isatuximab
Anti-CD38 mAb
1-3L Relapsing Refractory MM (IKEMA)
Dupixent®(**)
dupilumab
Atopic Dermatitis 12 - 17 years old (U.S.(5)/EU)
   

O

cemiplimab(**) + REGN4659(1)
PD-1 inhibitor mAb + Anti-CTLA-4 mAb
NSCLC
sarilumab(**)
Anti-IL6R mAb
Systemic Juvenile Arthritis
venglustat
Oral GCS inhibitor
Gaucher related Parkinson's Disease
dupilumab(**)
Anti-IL4Ralpha mAb
Eosinophilic Esophagitis
Aubagio®
teriflunomide
Relapsing Multiple Sclerosis - Pediatric
Praluent®(**)
alirocumab
CV events reduction (U.S./EU)
 

O

cemiplimab(**) + REGN4018(1)
PD-1 inhibitor mAb + Anti-MUC16-CD3 bispecific mAb - Ovarian Cancer)
SAR440340(**)
Anti-IL33 mAb
COPD
mavacamten(3)(**)
Myosin inhibitor
Non -Obstructive Hypertrophic Cardiomyopathy
Dupixent®(**)
dupilumab
Atopic Dermatitis 6 - 11 years old
Lemtrada®
alemtuzumab
Relapsing Remitting Multiple Sclerosis - Pediatric
VaxiGrip® QIV IM
Quadrivalent inactivated
Influenza vaccine 6 - 35 months
 
SAR439859
SERD + Palbociclib
Metastatic Breast Cancer
dupilumab(**) + AR101-CODIT
Anti-IL4Ralpha mAb
Peanut Allergy - Pediatric
Rabies VRVg
Purified vero rabies vaccine
Dupixent®(**)
dupilumab
Atopic Dermatitis 6 months - 5 years old
ZynquistaTM(**)
Oral SGLT-1&2 inhibitor
Worsening Heart Failure in Diabetes
PR5i
DTP-HepB-Polio-Hib
 Pediatric hexavalent vaccines (U.S.)
sutimlimab(2)
Anti Complement C1s mAb
Immune Thrombocytopenia

R

cemiplimab(**)
PD-1 inhibitor mAb
Advanced Basal Cell Carcinoma
Adacel+
Tdap booster
 sarilumab(**)
Anti-IL6R mAb
Giant Cell Arteritis
ZynquistaTM(**)
Oral SGLT-1&2 inhibitor
Type 2 Diabetes
Fluzone® 0,5 mL QIV
Quadrivalent inactivated
Influenza vaccine 6 months+
 
  isatuximab + cemiplimab(**)
Anti-CD38 mAb + PD-1 inhibitor mAb
Relapsing Refractory MM
Shan 6
DTP-HepB-Polio-Hib
Pediatric  hexavalent vaccine
sarilumab(**)
Anti-IL6R mAb
Polymyalgia Rheumatica
Cerdelga®
eliglustat
Gaucher Type 1, switch from ERT - Pediatric
 
  isatuximab + cemiplimab(**)
Anti-CD38 mAb + PD-1 inhibitor mAb
Advanced Malignancies
  cemiplimab(**)
PD-1 inhibitor mAb
1L NSCLC
Praluent®(**)
alirocumab
LDL-C reduction - Pediatric
 
  cemiplimab(**)
PD-1 inhibitor mAb
2L NSCLC
  cemiplimab(**)
PD-1 inhibitor mAb
2L Cervical Cancer
Fluzone® QIV HD
Quadrivalent inactivated
Influenza vaccine - High dose
 
  isatuximab + atezolizumab(**)
Anti-CD38 mAb + PD-L1 inhibitor mAb
Advanced Malignancies
  cemiplimab(**)+ ipilimumab
PD-1 inh. mAb + CTLA4 mAb
1L NSCLC< 50% PDL1+
Men Quad TT
Advanced generation meningococcal
ACYW conjugate vaccine
 
      cemiplimab(**)+ ipilimumab
PD-1 inh. mAb + CTLA4 mAb
1L NSCLC >= 50% PDL1+
Pediatric pentavalent vaccine
DTP-Polio-Hib
Japan
 
      isatuximab
Anti-CD38 mAb
1L Newly Diagnosed MM Ti(4) (IMROZ)
   

  1. Regeneron product for which Sanofi has opt-in rights
  2. Also known as BIVV009
  3. Also known as SAR439152 and MYK461
  4. Transplant ineligible
  5. U.S. filing pending acceptance by FDA
 (*)     Phase of projects determined by clinicaltrials.gov disclosure timing
(**)    Partnered and/or in collaboration - Sanofi may have limited or shared rights on some of these products

Expected Submission Timeline(1)

  New Molecular Entities Additional Indications
         
2019(2) isatuximab
anti-CD38 mAb
3L RRMM (ICARIA)
  Dupixent®(**)
dupilumab
AD 6 - 11 years old
dupilumab(**)
Anti-IL4Ra mAb
Nasal Polyposis Adult
SAR341402
Rapid acting insulin
Type 1/2 Diabetes - EU(3)
  Fluzone® QIV HD
Quadrivalent inactivated
Influenza vaccine - High dose
Men Quad TT
Adv. generation meningococcal
U.S.: 2y+ & EU: Toddlers+
    Pentacel® vIPV
DTaP-IPV/Hib
 
         
2020(2)  

olipudase alfa
rhASM
ASD(4)

 
fitusiran
RNAi therapeutic targeting anti-thrombin
Hemophilia A/B
sarilumab(**)
Anti-IL6R mAb
Polyarticular Juvenile Idiopathic Arthritis
isatuximab
Anti-CD38 mAb
1-3L RRMM (IKEMA)
 

avalglucosidase alfa
NeoGAA
Pompe Disease

 
 

 
cemiplimab(**)
PD-1 inhibitor mAb
2L Cervical Cancer
ZynquistaTM(**)
Oral SGLT-1&2 inhibitor
Type 2 Diabetes
sutimlimab(5)
Anti Complement C1s mAb
Cold Agglutinin Disease

 
  cemiplimab(**)
PD-1 inhibitor mAb
Advanced BCC
Aubagio®
teriflunomide
Relapsing MS - Pediatric
      cemiplimab(**)
PD-1 inhibitor mAb
1L NSCLC
Shan 6
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine

  New Molecular Entities Additional Indications
2021(2)

 
efpeglenatide(**)
Long acting GLP1-R agonist
Type 2 Diabetes
  isatuximab
Anti-CD38 mAb
1L Newly Diagnosed MM Ti (IMROZ)
ZynquistaTM(**)
Oral SGLT 1/2 inhibitor
Worsening Heart Failure in Diabetes
venglustat
Oral GCS inhibitor
ADPKD(6)
    Pediatric pentavalent vaccine
DTP-Polio-Hib (Japan)
        Adacel+
Tdap booster
         
2022
and beyond(2)
 

GZ389988
TRKA antagonist
Osteoarthritis

 
SAR156597
 IL4/IL13 bispecific mAb
Systemic Scleroderma
Dupixent®(**)
dupilumab
AD 6 months - 5 years old
sarilumab(**)
Anti-IL6R mAb
Systemic Juvenile Arthritis
SAR440340(**)
Anti-IL33 mAb
Asthma
ALX0171
Anti RSV Nanobody
Respiratory Syncitial Virus
dupilumab(**)
Anti-IL4Ra mAb
Eosinophilic Esophagitis
dupilumab(**)
Anti-IL4Ralpha mAb
Asthma 6 - 11 years old
Combination
ferroquine / OZ439
(**)
 Antimalarial
SAR407899
rho kinase
Microvascular Angina 
SAR440340(**)
Anti-IL33 mAb
COPD
sarilumab(**)
Anti-IL6R mAb
Polymyalgia Rheumatica
SAR422459
ABCA4 gene therapy
Stargardt Disease
SP0232 mAbs(7)(**)
Respiratory Syncytial Virus
sarilumab(**)
Anti-IL6R mAb
Giant Cell Arteritis
venglustat
Oral GCS inhibitor
Fabry Disease
SAR228810
Anti-protofibrillar AB mAb
Alzheimer's Disease
HIV
Viral vector prime & rgp120 boost vaccine
dupilumab(**) + AR101-CODIT
Anti-IL4Ralpha mAb
Peanut Allergy - Pediatric
venglustat
Oral GCS inhibitor
Gaucher Type 3
SAR425899
GLP-1/GCG dual agonist
Obesity/Overweight in T2D
   isatuximab
Anti-CD38 mAb
Newly Diagnosed MM Te
Cerdelga®
eliglustat
Gaucher Type 1, switch from ERT
Pediatric
    Praluent®(**)
alirocumab
LDL-C reduction - Pediatric
Rabies VRVg
Purified vero rabies vaccine
      venglustat
Oral GCS inhibitor
GrPD(8)
 

  1. Excluding Phase 1
  2. Projects within a specified year are not arranged by submission timing
  3. Submission strategy for the U.S. under evaluation
  4. Acid Sphingomyelinase Deficiency
  5. Also known as BIVV009; Currently operating as separate entities. Reported dates are based on prior Bioverativ disclosure of study completion date
  6. Autosomal Dominant Polycystic Kidney Disease
  7. Also known as MEDI8897
  8. Gaucher Related Parkinson's Disease
(**)     Partnered and/or in collaboration - Sanofi may have limited or shared rights on some of these products

Pipeline Movements Since Q2 2018

  Additions Removals
Registration Dupixent®(**)
dupilumab
Atopic Dermatitis 12 - 17 years old (U.S.(1)/EU)
     

 
         
         
Phase 3 isatuximab
Anti-CD38 mAb
Newly Diagnosed MM Te
 sarilumab(**)
Anti-IL6R mAb
Giant Cell Arteritis
   

 
  dupilumab(**)
Anti-IL4Ralpha mAb
Eosinophilic Esophagitis
sarilumab(**)
Anti-IL6R mAb
Polymyalgia Rheumatica
   
         
Phase 2 isatuximab + atezolizumab(**)
Anti-CD38 mAb + PD-L1 inhibitor mAb
Advanced Malignancies
     
  dupilumab(**) + AR101-CODIT
Anti-IL4Ralpha mAb
Peanut Allergy - Pediatric
     
         
Phase 1 SAR442720(**)
SHP2 inhibitor
Solid Tumors
SAR440234
T cell engaging multi spe mAb
Leukemia
   
         

(**)    Partnered and/or in collaboration - Sanofi may have limited or shared rights on some of these products
(1)    U.S. filing pending acceptance by FDA

Appendix 7: Expected R&D milestones

Products Expected milestones Timing
Fluzone® QIV HD Phase 3 results for prevention of Influenza Q4 2018
efpeglenatide Start of Phase 3 in Type 2 Diabetes as add-on to basal insulins Q4 2018
Dupixent® U.S. FDA filing in Atopic Dermatitis in Adolescent patients Q4 2018
dupilumab Start of Phase 2b/3 trial in Chronic Obstructive Pulmonary Disease Q1 2019
dupilumab U.S. sBLA filing in Nasal Polyposis Q1 2019
isatuximab Phase 3 results in Multiple Myeloma in combination with PomDex (ICARIA) Q1 2019
Dupixent® EU regulatory decision in Asthma in Adult/Adolescent patients Q1 2019
Dupixent® U.S. regulatory decision in Atopic Dermatitis in Adolescent patients Q1 2019
ZynquistaTM (sotagliflozin) EU regulatory decision expected in Type 1 Diabetes Q1 2019
ZynquistaTM (sotagliflozin) U.S. regulatory decision expected in Type 1 Diabetes Q1 2019
Praluent® EU regulatory decision in CV events reduction ODYSSEY OUTCOMES Q1 2019
Cablivi® (caplacizumab) U.S. regulatory decision in acquired Thrombotic Thrombocytopenic Purpura Q1 2019
Praluent® U.S. regulatory decision in CV events reduction ODYSSEY OUTCOMES Q2 2019
cemiplimab EU regulatory decision expected in Advanced Cutaneous Squamous Cell Carcinoma Q2 2019
BIVV001 Expected proof of concept study read-outs in Hemophilia A H1 2019
Dupixent® EU regulatory decision in Atopic Dermatitis in Adolescent patients Q3 2019
sutimlimab Expected pivotal trial read-outs in Cold Agglutinin Disease H2 2019

Appendix 8: Definitions of non-GAAP financial indicators

Company

"Company" corresponds to Sanofi and its subsidiaries

Company sales at constant exchange rates (CER)

When we refer to changes in our net sales "at constant exchange rates" (CER), this means that we exclude the effect of changes in exchange rates.

We eliminate the effect of exchange rates by recalculating net sales for the relevant period at the exchange rates used for the previous period.

Reconciliation of net sales to Company sales at constant exchange rates for the third quarter and first nine months 2018

€ million Q3 2018 9M 2018
Net sales 9,392 25,466
Effect of exchange rates (232) (1,459)
Company sales at constant exchange rates 9,624 26,925

Business net income

Sanofi publishes a key non-GAAP indicator.
Business net income is defined as net income attributable to equity holders of Sanofi excluding:

  1. Reported in the line items Restructuring costs and similar items and Gains and losses on disposals, and litigation, which are defined in Note B.20. to our consolidated financial statements.

Q3 2018 results