31.07.2017 07:30:00 CET

Sanofi Raises FY 2017 Business EPS(1) Guidance to Broadly Stable at CER(2)

Paris, July 31, 2017

Sanofi Raises FY 2017 Business EPS(1) Guidance to Broadly Stable at CER(2)

  Q2 2017 Change Change
at CER
Change
at CER/CS(3)
H1 2017 Change Change
at CER
Change
at CER/CS(3)
IFRS net sales reported 8,663m +6.4% +5.5% +0.6% 17,311m +8.7% +7.0% +2.0%
IFRS net income reported 1,037m -10.4% - - 6,738m +200.1% - -
IFRS EPS reported 0.82 -8.9% - - 5.35 +207.5% - -
Business net income(1) 1,696m +1.0% -0.5% - 3,491m +2.6% +0.3% -
Business EPS(1) 1.35 +3.1% +1.5% - 2.77 +4.9% +2.7% -

Second-quarter and first-half 2017 accounts reflect the acquisition of the former Boehringer Ingelheim Consumer Healthcare (CHC) business and the disposal of the Animal Health business (completed on January 1, 2017(4)). In accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations), Animal Health results in 2016 and gain on disposal in 2017 are reported separately. Second-quarter and first-half 2017 income statements also reflect the consolidation of European operations related to Sanofi vaccine portfolio, following the termination of the Sanofi Pasteur MSD joint venture (SPMSD JV) with Merck at the end of December 2016.

Q2 2017 sales growth supported by Specialty Care, Vaccines and Emerging Markets

  • Net sales were 8,663 million, up 6.4% on a reported basis and 5.5%(2) at CER reflecting the change in scope of the CHC and vaccines Global Business Units (GBUs). At CER and CS(3), net sales were up 0.6%.
  • Sanofi Genzyme GBU grew 14.3% at CER driven primarily by continued strong sales growth in Multiple Sclerosis; strong U.S. launch of Dupixent in atopic dermatitis driven by high unmet medical need and early market access.
  • Sanofi Pasteur GBU grew 19.2% at CER and CS as a result of strong sales of pediatric combinations and Menactra.
  • Diabetes and Cardiovascular GBU sales were down 15.0% at CER; Global Diabetes franchise sales decreased 12.2%.
  • CHC GBU sales were stable at CER and CS mainly due to seasonality in Europe.
  • Emerging Markets(5) sales increased 6.6% at CER and CS driven by robust contribution from China.
2017 business EPS guidance at CER raised on first-half financial results and disciplined expense management

  • Q2 2017 business operating income of 2,299 million, up 4.1% at CER and constant structure.
  • Q2 2017 business EPS(1) grew 1.5% at CER to 1.35 and increased 3.1% on a reported basis.
  • Sanofi now expects 2017 business EPS(1) to be broadly stable(6) at CER, barring unforeseen major adverse events.
  • Currency impact on 2017 business EPS is estimated to be approximately +1% at the average June 2017 exchange rates.
Sustaining innovation in R&D
  • Positive CHMP opinion received for Dupixent in the EU.
  • Kevzara, an anti IL6 for the treatment of rheumatoid arthritis, approved in the EU in June.
  • Initiation of Phase 3 ATLAS program for fitusiran in patients with hemophilia.
  • Phase 2/3 studies started for SAR439684 (anti PD-1) in Non-Small Cell Lung Cancer and Basal Cell Carcinoma.

Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"Sanofi Genzyme, Sanofi Pasteur and Emerging Markets were once again major contributors to our performance in the quarter. The continued growth of these businesses, together with disciplined expense management, enabled us to more than offset the headwinds in our Diabetes franchise. Consequently, we feel confident in our full-year outlook and raise our 2017 business EPS guidance. We are also encouraged by the strong uptake of Dupixent in the U.S. and the approval of Kevzara. The initiation of Phase 3 studies in additional indications for dupilumab, the Phase 2/3 programs with the anti PD-1 in multiple cancer indications and fitusiran in hemophilia were significant R&D milestones in the second quarter."

(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 10 for definitions). The consolidated income statement for Q2 2017 and H1 2017 is provided in Appendix 3 and a reconciliation of IFRS net income reported to business net income is set forth in Appendix 4; (2) changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 10); (3) CS: constant structure: adjusted for BI CHC business, termination of SPMSD and others; (4) The closing of the disposal of Merial in Mexico is expected in 2017; (5) See definition page 8; (6) 2016 Business EPS was 5.68 

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
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2017 second-quarter and first-half Sanofi sales

Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(7).

In the second quarter of 2017, Company sales were 8,663 million, up 6.4% on a reported basis. Exchange rate movements had a favorable effect of 0.9 percentage points mainly reflecting the positive evolution of the U.S. dollar, Brazilian Real and Russian Ruble which more than offset the negative impact from the Egyptian Pound, Turkish Lira, British Pound and Chinese Yuan. Company sales benefited from the acquisition of Boehringer Ingelheim's CHC business and full consolidation of Sanofi's European vaccines operations leading to an increase of 5.5% at CER. At CER and constant structure, Company sales were up 0.6%.

First-half Company sales reached 17,311 million, up 8.7% on a reported basis. Exchange rate movements had a favorable effect of 1.7 percentage points. At CER and constant structure, Company sales were up 2.0%.

Global Business Units

The table below presents sales by Global Business Unit (GBU) and reflects the organization of Sanofi. This structure drives deeper specialization, simplifies reporting and provides clear focus on growth drivers. Please note that in Emerging Markets, Specialty Care and Diabetes and Cardiovascular sales are included in the General Medicines and Emerging Markets GBU.

Net Sales by GBU
( million)
Q2 2017 Change
(CER)
Change
CER/CS*
H1 2017 Change
(CER)
Change
CER/CS*
Sanofi Genzyme (Specialty Care)(a)   1,439   +14.3% +14.4% 2,818 +14.9% +14.9%
Diabetes and Cardiovascular(a)   1,386   -15.0% -15.0% 2,805 -11.4% -11.4%
General Medicines & Emerging Markets(b)   3,659   -1.2% -1.3% 7,384 +0.5% +0.3%
Consumer Healthcare (CHC)   1,163   +42.5% -0.1% 2,504 +42.6% +2.4%
Total Pharmaceuticals   7,647   +3.2% -1.5% 15,511 +5.3% +0.6%
Sanofi Pasteur (Vaccines)   1,016   +26.2% +19.2% 1,800 +24.5% +16.5%
Total net sales   8,663   +5.5% +0.6% 17,311 +7.0% +2.0%

(a) Does not include Emerging Markets sales- see definition page 7; (b) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care
*CS: constant structure

Global Franchises

The tables below present second-quarter and first-half 2017 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)
Q2 2017 Change
(CER)
Change
at CER/CS*
Developed
Markets
Change
at CER/CS*
Emerging
Markets
Change
at CER/CS*
Specialty Care 1,711 +13.5% +13.6% 1,439 +14.4% 272 +9.7%
Diabetes and Cardiovascular 1,772 -10.7% -10.7% 1,386 -15.0% 386 +8.6%
Established Rx Products 2,559 -2.3% -2.6% 1,592 -6.1% 967 +3.5%
Consumer Healthcare (CHC) 1,163 +42.5% -0.1% 762 -2.3% 401 +4.6%
Generics 442 -8.0% -7.6% 253 -6.7% 189 -8.9%
Vaccines 1,016 +26.2% +19.2% 602 +17.3% 414 +22.2%
Total net sales 8,663 +5.5% +0.6% 6,034 -1.8% 2,629 +6.6%

*CS: constant structure

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

Net sales by Franchise
( million)
H1 2017 Change
(CER)
Change
at CER/CS*
Developed
Markets
Change
at CER/CS*
Emerging
Markets
Change
at CER/CS*
Specialty Care 3,331 +14.5% +14.6% 2,818 +14.9% 513 +12.7%
Diabetes and Cardiovascular 3,567 -7.5% -7.5% 2,805 -11.4% 762 +10.4%
Established Rx Products 5,199 -0.9% -1.2% 3,226 -5.1% 1,973 +5.9%
Consumer Healthcare (CHC) 2,504 +42.6% +2.4% 1,699 +2.1% 805 +3.0%
Generics 910 -5.0% -4.7% 521 -5.8% 389 -3.2%
Vaccines 1,800 +24.5% +16.5% 1,070 +16.1% 730 +17.1%
Total net sales 17,311 +7.0% +2.0% 12,139 -0.1% 5,172 +7.5%

  *CS: constant structure

Pharmaceuticals

Second-quarter Pharmaceuticals sales were up 3.2% to 7,647 million. At constant structure, Pharmaceuticals sales were down 1.5% primarily due to Diabetes and Established products. First-half sales for Pharmaceuticals increased 5.3% (+0.6% at constant structure) to 15,511 million.

Rare Disease franchise

Net sales ( million) Q2 2017 Change
(CER)
H1 2017 Change
(CER)
Myozyme / Lumizyme 203 +10.4% 393 +11.5%
Cerezyme 193 -2.0% 369 -3.4%
Fabrazyme 190 +12.0% 367 +13.6%
Aldurazyme 57 +12.0% 109 +10.2%
Cerdelga 31 +19.2% 62 +24.5%
Others 78 -4.8% 164 -0.6%
Total Rare Diseases 752 +5.9% 1,464 +6.7%

In the second quarter, Rare Disease sales increased 5.9% to 752 million driven by the accrual of patients worldwide. Rare Disease sales grew 6.8% in the U.S., 10.2% in Emerging Markets and 3.4% in Europe. First-half Rare Disease sales increased 6.7% to 1,464 million.

Gaucher (Cerezyme and Cerdelga) sales were slightly up (0.4%) at 224 million in the second quarter. Cerezyme sales were down 2.0% to 193 million reflecting a strong base for comparison. Cerdelga sales increased 19.2% to 31 million of which 23 million were generated in the U.S. (up 15.0%). First half Gaucher sales were 431 million (down 0.2%).

Second-quarter Fabrazyme sales were up 12.0% to 190 million, reflecting a continued accrual of new patients. First-half Fabrazyme sales were up 13.6% to 367 million.

Myozyme/Lumizyme sales grew 10.4% to 203 million in the second quarter, mainly due to new patient accruals and increased worldwide diagnosis of Pompe disease. First-half Myozyme/Lumizyme sales increased 11.5% to 393 million.

Multiple Sclerosis franchise

Net sales ( million) Q2 2017 Change
(CER)
H1 2017 Change
(CER)
Aubagio 425 +32.7% 796 +31.3%
Lemtrada 124 +13.9% 249 +26.0%
Total Multiple Sclerosis 549 +27.9% 1,045 +30.0%

Second-quarter Multiple Sclerosis (MS) sales grew 27.9% to 549 million, reflecting strong Aubagio growth. First-half MS sales increased 30.0% to 1,045 million.

Second-quarter Aubagio sales increased 32.7% to 425 million driven by the U.S. (up 28.7% to 285 million) and Europe (up 42.5% to 114 million). In the U.S., Aubagio achieved a market share of 9.3% (source IMS TRX-Q2 2017). First-half Aubagio sales increased 31.3% to 796 million.

In the second quarter Lemtrada sales increased 13.9% to 124 million, including 63 million in the U.S. (up 10.7%) and 47 million in Europe (up 22.5%). First-half Lemtrada sales increased 26.0% to 249 million.

Immunology franchise

Net sales ( million) Q2 2017 Change
(CER)
H1 2017 Change
(CER)
Dupixent 26 - 26 -
Kevzara 1 - 1 -
Total Immunology 27 - 27 -

Dupixent which was launched in the U.S. in March for the treatment of moderate to severe adult atopic dermatitis generated sales of 26 million in the second quarter. Since the launch, over 5,100 physicians in the U.S. have prescribed Dupixent (as of July 26, 2017) and cumulatively over 13,000 patients have been prescribed Dupixent since launch (as of July 26, 2017). In Europe, Dupixent received a positive recommendation from the CHMP on July 21st 2017.

Kevzara, an anti IL6 treatment for rheumatoid arthritis, was launched in June in the U.S. and approved in EU.

Oncology franchise

Net sales ( million) Q2 2017 Change
(CER)
H1 2017 Change
(CER)
Jevtana 100 +12.5% 197 +9.0%
Thymoglobulin 76 +8.7% 148 +8.2%
Taxotere 44 -6.5% 91 -2.2%
Eloxatin 45 0.0% 90 +3.5%
Mozobil 40 +8.1% 80 +9.7%
Zaltrap 18 +5.9% 34 0.0%
Others 60 -3.2% 155 +21.6%
Total Oncology 383 +4.4% 795 +8.6%

Second-quarter Oncology sales increased 4.4% to 383 million driven mainly by Jevtana and Thymoglobulin. First-half Oncology sales were up 8.6% to 795 million.

Jevtana sales were up 12.5% to 100 million in the second quarter supported by the performance in the U.S. and Japan. First-half Jevtana sales increased 9.0% to 197 million.

In the second quarter, Thymoglobulin sales increased 8.7% to 76 million driven by the U.S. (up 7.7% to 44 million) and Emerging Markets (up 30.8% to 17 million). First-half Thymoglobulin sales increased 8.2% to 148 million.

Eloxatin sales were stable at 45 million in the second quarter. Second-quarter Taxotere sales decreased 6.5% (to 44 million) due to continued generic competition in Japan. First-half sales of Taxotere and Eloxatin were down 2.2% (91 million) and up 3.5% (90 million), respectively.

Diabetes franchise

Net sales ( million) Q2 2017 Change
(CER)
H1 2017 Change
(CER)
Lantus 1,197 -19.2% 2,423 -16.7%
Toujeo 210 +46.1% 402 +59.8%
Total glargine 1,407 -13.5% 2,825 -10.7%
Apidra 93 -2.2% 191 +5.6%
Amaryl 85 -5.4% 174 0.0%
Insuman 28 -14.7% 55 -15.2%
BGM (Blood Glucose Monitoring) 16 -5.9% 33 -2.9%
Lyxumia 7 -12.5% 14 -17.6%
Soliqua 5 - 9 -
Total Diabetes 1,647 -12.2% 3,310 -9.2%

In the second quarter, Diabetes sales decreased 12.2% to 1,647 million, reflecting lower Lantus sales in the U.S. Second-quarter U.S. Diabetes sales were down 23.0% to 814 million. First-half U.S. Diabetes sales decreased 19.1% to 1,653 million. In the second half of 2017, Sanofi expects an accelerated decline of U.S. diabetes sales relative to the first half of 2017. This reflects the phased impact of exclusions in commercial formularies at CVS and United Health as well as a high basis of comparison in last year's fourth quarter. Second-quarter sales in Emerging Markets increased 8.4% to 383 million. Sales in Europe were 325 million, a decrease of 3.0% in the second quarter. First-half Diabetes sales decreased 9.2% to 3,310 million.

In the second quarter, Sanofi glargine (Lantus and Toujeo) sales decreased 13.5% to 1,407 million. In the U.S., Sanofi glargine sales of 782 million were down 23.9% and reflected the impact of the exclusion from various CVS commercial formularies from January 1, 2017 as well as from the United Health commercial formulary which became effective on April 1, 2017. In Europe, Sanofi glargine sales decreased 2.0% to 248 million due to biosimilar competition in several European markets. First-half Sanofi glargine sales decreased 10.7% to 2,825 million.

Over the quarter, Lantus sales were 1,197 million down 19.2%. In the U.S., Lantus sales decreased 28.1% to 660 million mainly reflecting lower average net price and the aforementioned impact of formulary exclusions. In Europe, second-quarter Lantus sales were 194 million (down 14.0%) due to biosimilar competition and patients switching to Toujeo. In Emerging Markets, sales were up 5.6% to 262 million. First-half Lantus sales decreased 16.7% to 2,423 million.

Second-quarter Toujeo sales were 210 million (up 46.1%) of which 122 million (up 12.3%) were recorded in the U.S., 54 million in Europe (versus 27 million in the second quarter of 2016) and 19 million in Emerging Markets (versus 1 million in the second quarter of 2016). First-half Toujeo sales increased 59.8% to 402 million.

Amaryl sales were 85 million, down 5.4% in the second quarter, of which 69 million were generated in Emerging Markets (down 2.7%). First-half Amaryl sales were stable at 174 million.

Second-quarter Apidra sales decreased 2.2% to 93 million. Lower sales in the U.S. (down 13.3% to 27 million) were partially offset by double-digit growth in Emerging Markets (up 15.0% to 23 million). First-half Apidra sales increased 5.6% to 191 million.

Soliqua 100/33 / SuliquaTM (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) was launched in the U.S. in January 2017 and SuliquaTM recently in the first European country, the Netherlands. Soliqua 100/33 / SuliquaTM sales were 5 million in the second quarter and 9 million in the first half.

Cardiovascular franchise

Second-quarter Praluent sales (collaboration with Regeneron) were 42 million of which 29 million was in the U.S. and 11 million in Europe. This reflected significant payer utilization management restrictions in the U.S. and limited market access in Europe. First-half Praluent sales were 76 million versus 33 million in the first half of 2016. In January 2017, the U.S. District Court for the District of Delaware issued an injunction that required Sanofi and Regeneron to stop marketing, selling and manufacturing Praluent in the U.S. starting from February 21, 2017. However, on February 8, 2017, the Court of Appeals for the Federal Circuit stayed (suspended) the permanent injunction for Praluent during the companies' appeal. As a result, Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent in the U.S. during the appeal process. The Court of Appeals oral arguments were heard on June 6, 2017. The companies now await a decision from the Court of Appeals on the appeal issues. It is at the Court's discretion when to issue a decision.

Second-quarter and first-half Multaq sales were 83 million (down 3.6%) and 181 million (up 3.5%), respectively.

Established Rx Products

Net sales ( million) Q2 2017 Change
(CER)
H1 2017 Change
(CER)
Lovenox 402 -2.4% 817 -0.1%
Plavix 385 -0.3% 765 -1.0%
Renvela/Renagel 248 +16.8% 494 +9.0%
Aprovel/Avapro 190 +9.1% 383 +11.0%
Synvisc /Synvisc-One 116 +4.6% 206 +2.0%
Myslee/Ambien/Stilnox 64 -19.2% 137 -10.8%
Allegra 34 -12.8% 102 -13.2%
Other 1,120 -7.1% 2,295 -3.7%
Total Established Rx Products 2,559 -2.3% 5,199 -0.9%

In the second quarter, Established Rx Products sales decreased 2.3% to 2,559 million. This reflected a decline in sales in Europe (down 6.3% to 881 million) and the impact of generic competition to Plavix in Japan, which more than offset a solid Emerging Markets performance (up 3.5% to 967 million). First-half Established Rx Products sales decreased 0.9% to 5,199 million.

Lovenox sales decreased 2.4% to 402 million in the second quarter, reflecting increased competition in Europe (down 7.3% to 243 million) following the availability of a biosimilar, which offset the strong performance in Emerging Markets (up 9.7% to 123 million). First-half Lovenox sales were stable at 817 million.

In the second quarter, Plavix sales were down 0.3% to 385 million due to generic competition in Japan that started in June 2015 (sales in Japan were down 31.2% to 64 million). In Emerging Markets, Plavix sales increased 12.8% to 266 million sustained by the performance in China. First-half Plavix sales decreased 1.0% to 765 million.

Second-quarter Renvela/Renagel sales increased 16.8% to 248 million driven by the U.S. performance (up 20% to 209 million). In the U.S. the first generics of Renvela/Renagel powder and tablet formulations were approved in June and July, respectively. In Europe, Renvela/Renagel sales were down 14.3% to 19 million due to generic competition. First-half Renvela/Renagel sales increased 9.0% to 494 million.

Aprovel/Avapro sales were up 9.1% (to 190 million) driven by product sales to Sanofi's partner in Japan and sales in China. First-half Aprovel/Avapro sales increased 11.0% to 383 million.

Consumer Healthcare

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

Net sales ( million) Q2 2017 Change
(CER)
Change
at CER/CS*
H1 2017 Change
(CER)
Change
at CER/CS*
Allergy Cough & Cold 255 +42.6% -1.6% 669 +52.1% +6.7%
   of which Allegra 106 +6.2% +6.2% 251 +2.1% +2.1%
   of which Mucosolvan 18 na na 53 na na
   of which Xyzal 8 - - 51 - -
Pain 297 +36.4% -1.7% 621 +40.8% +4.1%
   of which Doliprane 73 -3.9% -3.9% 156 +1.9% +1.9%
   of which Buscopan 38 na na 80 na na
Digestive 239 +84.9% +2.2% 468 +69.4% -3.2%
   of which Dulcolax 56 na na 103 na na
   of which Enterogermina 42 -2.3% -2.3% 89 +3.5% +3.5%
   of which Essentiale 40 +15.6% +15.6% 75 -2.8% -2.8%
   of which Zantac 30 na na 57 na na
Nutritionals 170 +54.2% -1.2% 334 +45.0% -1.2%
   of which Pharmaton 31 na na 48 na na
Other 202 +12.4% +2.6% 412 +11.7% +2.8%
   of which Gold Bond 50 +4.3% +4.3% 100 +3.2% +3.2%
Total Consumer Healthcare 1,163 +42.5% -0.1% 2,504 +42.6% +2.4%

*CS: constant structure

In the second quarter, Consumer Healthcare (CHC) sales increased 42.5% to 1,163 million reflecting the closing of the acquisition of Boehringer Ingelheim CHC business on January 1st, 2017. At constant structure, Sanofi CHC sales were stable in the second quarter and were impacted by an early start of the Cough and Cold season in Europe in the first quarter of the year. At constant structure, first-half CHC sales increased 2.4% to 2,504 million.

In Europe, second-quarter CHC sales were up 44.6% to 308 million. At constant structure, sales decreased 7.8%, following an early Cough and Cold season in the first quarter of 2017. Sales of the Allergy Cough and Cold and Pain products were down 14.5% and 10.3%, respectively. At constant structure, first-half CHC sales in Europe increased 1.6% to 714 million.

In the U.S., second-quarter CHC sales increased 24.0% to 293 million. At constant structure, CHC sales were up 2.5% driven by the Pain and Allergy portfolios. In the allergy segment, Sanofi gained market share thanks to the good performance of Allegra and the launch of Xyzal Allergy 24HR (approved in February as an over-the-counter treatment for the relief of symptoms associated with seasonal and year-round allergies) in a competitive environment. Second-quarter sales of the Digestive category were down 9.3% reflecting lower Zantac sales mostly due to retailer delistings of DUO fusionTM. In the U.S., at constant structure, first-half CHC sales increased 2.5% to 641 million.

In Emerging Markets, second-quarter CHC sales increased 33.9% to 401 million. At constant structure, CHC sales were up 4.6% reflecting the start of recovery in Russia. In the first half, Emerging Markets CHC sales increased 3.0% to 805 million at constant structure.

In the Rest of the World, CHC sales were up 133.3% to 161 million. At constant structure, CHC sales were up 0.6% negatively impacted by lower sales of the Allergy Cough and Cold products in Japan and the Nutritional portfolio in Australia. In the Rest of the World, at constant structure, first-half CHC sales increased 2.8% to 344 million.

Generics

In the second quarter, Generics sales decreased 8.0% to 442 million reflecting lower sales in Europe (down 7.3% to 190 million), the U.S. (down 28.9% to 32 million) and Emerging Markets (down 9.4% to 189 million). In Emerging Markets, sales were impacted primarily by the divestment of a third party distribution business in China and unfavorable phasing in Latin America. First-half Generics sales decreased 5.0% to 910 million.

Vaccines

Net sales ( million) Q2 2017 Change
(CER)
Change
at CER/CS*
H1 2017 Change
(CER)
Change
at CER/CS*
Polio/Pertussis/Hib vaccines
(incl. Hexaxim / Hexyon Pentacel, Pentaxim and Imovax)
469 +37.2% +31.4% 901 +41.3% +34.4%
Meningitis/Pneumonia vaccines
(incl. Menactra)
195 +38.1% +38.1% 290 +8.8% +8.8%
Adult Booster vaccines (incl. Adacel ) 115 +11.5% -6.5% 194 +4.3% -13.9%
Travel and other endemic vaccines 113 +10.9% 0.0% 219 +17.4% +3.8%
Influenza vaccines
(incl. Vaxigrip, Fluzone HD & Fluzone)
98 0.0% 0.0% 136 +14.7% +14.7%
Dengvaxia 1 0.0% 0.0% 18 -5.0% -5.0%
Other vaccines 25 +41.2% +33.3% 42 +33.3% +25.0%
Total Vaccines 1,016 +26.2% +19.2% 1,800 +24.5% +16.5%

*CS: constant structure

Second-quarter Vaccines sales were up 26.2% to 1,016 million and reflected the termination of the Sanofi Pasteur MSD joint-venture in Europe from December 31, 2016. At constant structure, sales were up 19.2% mainly driven by the Polio/Pertussis/Hib franchise and Menactra. In the U.S., sales were up 12.7% to 378 million. In Emerging Markets, sales grew 22.2% to 414 million. In Europe, sales were up 140.4% to 135 million reflecting the termination of SPMSD JV. At constant structure, European sales which are now fully managed by Sanofi Pasteur, were up 31.7%. First-half Vaccines sales grew 16.5% at constant structure to 1,800 million.

In the second quarter, Polio/Pertussis/Hib (PPH) vaccines sales increased 37.2% to 469 million. At constant structure, PPH sales grew 31.4% reflecting increased release of Pentaxim batches in China and strong performance of Hexaxim in Europe as well as in some Emerging markets. At constant structure, first-half Polio/Pertussis/Hib vaccines sales increased 34.4% to 901 million.

Second-quarter Menactra sales increased 41.3% to 181 million reflecting the CDC ordering pattern in the U.S., an outbreak in Australia and phasing in the Middle East. First-half Menactra sales increased 11.8% to 271 million.

Influenza vaccines sales were stable (98 million) in the second quarter and up 14.7% (136 million) in the first half driven by the South Hemisphere campaign. For the North Hemisphere, first shipment for U.S. Flu season was completed on July 17th and Sanofi Pasteur expects to deliver a similar number of Flu vaccine doses in the U.S. as in 2016.

Second-quarter Adult Booster vaccines sales were 115 million, up 11.5% and down 6.5% at constant structure due to the continuing impact of Repevax supply disruption in Europe. At constant structure, first-half Adult Booster vaccines sales decreased 13.9% to 194 million.

Second-quarter Travel and other endemic vaccines sales were 113 million up 10.9% and stable at constant structure.  At constant structure, first-half Travel and other endemic vaccines sales were up 3.8% to 219 million.

Second-quarter and first-half Dengvaxia sales were 1 million and 18 million, respectively.

In July, Sanofi announced it will acquire Protein Sciences, a U.S. privately held vaccines biotechnology company. This acquisition will allow Sanofi Pasteur to broaden its flu portfolio with the addition of a non-egg based vaccine. The acquisition, which has been unanimously approved by the board of directors of Protein Sciences and a majority of Protein Sciences shareholders, is expected to close in the third quarter of 2017, subject to customary regulatory approvals. 

Company sales by geographic region

Sanofi sales ( million) Q2 2017 Change
(CER)
Change
(CER/CS)
H1 2017 Change
(CER)
Change
(CER/CS)
United States 2,798 -1.0% -2.7% 5,562 +0.9% -0.8%
Emerging Markets(a) 2,629 +10.2% +6.6% 5,172 +10.7% +7.5%
  of which Latin America 729 +10.1% +3.9% 1,405 +13.9% +7.5%
  of which Asia (including South Asia(b)) 934 +11.7% +10.0% 1,917 +12.6% +11.2%
  of which Africa, Middle East 626 +4.7% +1.4% 1,172 +3.2% +0.4%
  of which Eurasia(c) 312 +17.9% +15.2% 610 +16.1% +12.6%
Europe(d) 2,350 +6.8% -1.0% 4,761 +8.6% +0.4%
Rest of the World(e) 886 +10.3% -1.1% 1,816 +12.6% +0.5%
  of which Japan 472 +10.0% -7.5% 1,001 +14.9% -4.0%
Total Sanofi sales 8,663 +5.5% +0.6% 17,311 +7.0% +2.0%

*CS : constant structure
(a) World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico
(b) India, Bangladesh, Sri Lanka
(c) Russia, Ukraine, Georgia, Belarus, Armenia and Turkey
(d) Western Europe + Eastern Europe except Eurasia
(e) Japan, South Korea, Canada, Australia, New Zealand, Puerto Rico

Second-quarter sales in the U.S. were 2,798 million, a decrease of 1.0% or 2.7% at constant structure impacted by the decline of Diabetes sales (down 23.0%) which was not fully offset by the strong performance of the Multiple Sclerosis franchise (up 25.0%), Vaccines (up 12.7%) as well as the launch of Dupixent. In the U.S., at constant structure, first-half sales decreased 0.8% to 5,562 million.

Second-quarter sales in Emerging Markets were 2,629 million, up 10.2% or 6.6% at constant structure driven by Vaccines (up 22.2%), Established Rx products (up 3.5%) and Diabetes (up 8.4%). In Asia, second quarter sales were up 11.7% (up 10.0% at constant structure) to 934 million reflecting strong performance in China (up 17.1% at constant structure to 550 million), driven by the recovery in Vaccines and growth of Established products. In Latin America, second quarter sales increased 10.1% (up 3.9% at constant structure) to 729 million. Second-quarter sales in Brazil decreased 3.0% at constant structure to 284 million. Second-quarter sales in the Eurasia region increased 17.9% (15.2% at constant structure) to 312 million supported by strong growth in Russia and Turkey. Over the quarter, sales in Russia were 163 million up 33.7% and 25.2% at constant structure driven by CHC sales growth. In Africa and the Middle East, sales were 626 million up 4.7% and 1.4% at constant structure. In Emerging Markets, at constant structure, first-half sales increased 7.5% to 5,172 million.

Second-quarter sales in Europe were 2,350 million, up 6.8% or down 1.0% at constant structure impacted by lower Established products (down 6.9% at constant structure) and CHC sales (down 7.8% at constant structure) which were not fully offset by the strong performance of the Multiple Sclerosis franchise (up 35.8%) and Vaccines (up 31.7%). In Europe, at constant structure, first-half sales increased 0.4% to 4,761 million.

Sales in Japan increased 10.0% to 472 million in the second quarter. At constant structure, sales in Japan were down 7.5% impacted by generic Plavix competition which was partially offset by strong growth of Vaccines sales. In Japan, at constant structure, first-half sales decreased 4.0% to 1,001 million.

R&D update

Consult Appendix 8 for full overview of Sanofi's R&D pipeline

Regulatory update

Regulatory updates since the publication of first-quarter results on April 28, 2017 include the following:

At the end of July 2017, the R&D pipeline contained 47 pharmaceutical new molecular entities (excluding Life Cycle Management) and vaccine candidates in clinical development of which 13 are in Phase 3 or have been submitted to the regulatory authorities for approval.

Portfolio update

Phase 3:

Phase 2:

Phase 1:

2017 Second-quarter and first-half financial results(8)

Business Net Income(8)

In the second quarter of 2017, Sanofi generated sales of 8,663 million, an increase of 6.4% (up 5.5% at CER). First-half sales were 17,311 million, up 8.7% on a reported basis (up 7.0% at CER).

Second-quarter other revenues increased 63.6% (up 61.2% at CER) to 270 million including VaxServe sales of non-Sanofi products of 195 million (versus 89 million in the second quarter of 2016). First-half other revenues increased 67.4% to 519 million of which 368 million were generated by VaxServe (up 108.1% at CER).

Second-quarter Gross Profit increased 6.1% to 6,136 million (up 4.9% at CER). At CER and CS*, Gross Profit increased 0.3%. The gross margin ratio decreased 0.2 percentage points to 70.8% versus the second quarter of 2016. The positive impact of the growing Multiple Sclerosis business, Vaccines and China was offset by the negative U.S. Diabetes net price evolution. In the second quarter, the gross margin ratio of Pharmaceuticals was 72.6%, a decrease of 0.5 percentage points and the gross margin ratio of Vaccines improved 5.2 percentage points to 57.5%. First-half Gross Profit increased 9.5% to 12,336 million (up 7.7% at CER and up 2.8% at CER and CS*). In the first half of 2017, the gross margin ratio improved by 0.6 percentage points to 71.3% versus the first half of 2016. Sanofi expects its gross margin ratio to be between 70% and 71% at CER in 2017.

Research and Development (R&D) expenses increased 6.2% to 1,358 million (up 5.1% at CER) in the second quarter. At CER and CS*, R&D expenses were up 3.1% reflecting mainly the increased spending on our development programs in immuno-oncology (isatixumab, PD-1) and sotagliflozin. First-half R&D expenses increased 6.1% to 2,667 million (up 4.6% at CER and up 2.6 % at CER and constant structure).

Second-quarter selling general and administrative expenses (SG&A) were up 7.1% to 2,568 million (up 6.1% at CER). At CER and CS*, SG&A expenses were down 0.9% mainly reflecting disciplined cost management. General expenses decreased 5.1% at CER and CS*, and Marketing expenses benefited from the reduction of the Diabetes sales and marketing spending in the U.S.  These savings offset launch costs for Dupixent, Kevzara and Xyzal as well as commercial and marketing investments behind key Emerging countries and Vaccines. In the second-quarter, the ratio of SG&A to sales increased 0.2 percentage points to 29.6% compared to the second quarter of 2016. First-half SG&A expenses increased 9.5% to 5,046 million (up 7.7% at CER and up 0.4% at CER and CS*). In the first half of 2017, the ratio of SG&A to sales was 0.2 percentage points higher at 29.1% compared to the same period of 2016.

Second-quarter other current operating income net of expenses was 68 million versus -23 million for the same period of 2016 and included a minor capital gain. First-half other current operating income net of expenses was 102 million versus 70 million in the first half of 2016.

The share of profits from associates was 51 million in the second quarter versus 30 million for the same period of 2016. The share of profits from associates included Sanofi's share in Regeneron profit. In the first half, the share of profits from associates was 81 million versus 53 million for the same period of 2016.

In the second quarter, non-controlling interests were -30 million versus -23 million in the second quarter of 2016. First-half non-controlling interests were -65 million versus -50 million for the same period of 2016.

Second-quarter business operating income increased 9.8% to 2,299 million. At CER, business operating income increased 8.5%. At CER and CS*, business operating income increased 4.1%. The ratio of business operating income to net sales increased 0.8 percentage points to 26.5% versus the same period of 2016. In the second quarter, the business operating income ratio of Pharmaceuticals was 27.3%, 0.2 percentage points lower and the business operating income ratio of Vaccines increased 8.1 percentage points to 20.0%. First-half business operating income was 4,741 million, up 12.5% (or up 10.1% at CER). At CER and CS*, business operating income increased 5.8%. In the first half of 2017, the ratio of business operating income to net sales increased 0.9 percentage point to 27.4%.

Net financial expenses were 60 million in the second quarter versus 74 million in the second quarter of 2016. First-half net financial expenses were 123 million versus 191 million in the first half of 2016.

Second-quarter (and first-half) effective tax rate was 24.5% compared to 23.2% in the second quarter of 2016.

Second-quarter business net income(9) increased 1.0% to 1,696 million (down 0.5% at CER). The ratio of business net income to net sales increased 0.5 percentage points to 19.6% versus the same period of 2016 (excluding Animal Health business).

(8) See Appendix 3 for 2017 second-quarter and first-half consolidated income statement; see Appendix 10 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income.
* Adjusted for BI CHC business and termination of SPMSD and others.

First-half business net income increased 2.6% to 3,491 million, (up 0.3% at CER). The ratio of business net income to net sales increased 0.7 percentage points to 20.2% compared to the first half of 2016 (excluding Animal Health business).

In the second quarter of 2017, business earnings per share(8) (EPS) increased 3.1% to 1.35 on a reported basis and 1.5% at CER. The average number of shares outstanding was 1,258.2 million in the second quarter of 2017 versus 1,286.8 million in the second quarter of 2016.

In the first half of 2017, business earnings per share(8) was 2.77, up 4.9% on a reported basis and up 2.7% at CER. The average number of shares outstanding was 1,260.3 million in the first half of 2017 versus 1,287.6 million in the first half of 2016.

2017 Guidance

Sanofi raises full-year 2017 business EPS(8) guidance to broadly stable at CER, barring unforeseen major adverse events. The currency impact on 2017 business EPS is estimated to be approximately +1% at the average June 2017 exchange rates. As announced in the first quarter 2017 financial results, Sanofi previously expected full-year 2017 business EPS to be stable to -3% at CER, barring unforeseen major adverse events.

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

In the first half of 2017, the IFRS net income was 6,738 million reflecting the acquisition of BI's CHC business and full consolidation of Sanofi's European vaccine operations. The main items excluded from the business net income were:

(8) See Appendix 3 for 2017 second-quarter and first-half consolidated income statement; see Appendix 10 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income.

Capital Allocation

In the first half of 2017, net cash generated by operating activities was 2,299 million after capital expenditures of 688 million and an increase in working capital of 1,185 million. This net cash flow funded acquisitions and partnerships net of disposals (246 million) and restructuring costs and similar items (438 million). The swap between BI CHC business and Sanofi Animal Health business generated a net cash flow of 4,349 million, partially used to finance share repurchases (1,698 million) over the period. As a consequence, net debt decreased from 8,206 million at December 31, 2016 to 7,463 million at June 30, 2017 (amount net of 10,877 million 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 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, 2016. 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:  2017 second-quarter and first-half net sales by GBU, franchise, geographic region and product

 
Appendix 2: 2017 second-quarter and first-half Business net income statement

 
Appendix 3: 2017 second-quarter and first-half Consolidated income statement

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

 
Appendix 5: Change in net debt

 
Appendix 6: Simplified consolidated balance sheet

 
Appendix 7: Currency sensitivity

 
Appendix 8: R&D pipeline

 
Appendix 9: Expected R&D milestones

 
Appendix 10: Definitions of non-GAAP financial indicators

 

Appendix 1: 2017 second-quarter net sales by GBU, franchise, geographic region and product

                 
Q2
2017
( million)
Total
GBUs
%
CER
%
re-
ported
Eu-
rope
%
CER
United
States
%
CER
Rest
of the
World
%
CER
Emer-
ging
Mar-
kets
%
CER
Total
Fran-
chises
%
CER
%
re-
ported
Aubagio 414 32.7% 35.3% 114 42.5% 285 28.7% 15 40.0% 11 33.3% 425 32.7% 34.9%
Lemtrada 118 13.6% 14.6% 47 22.5% 63 10.7% 8 -14.3% 6 20.0% 124 13.9% 14.8%
Total
MS
532 27.9% 30.1% 161 35.8% 348 25.0% 23 17.6% 17 28.6% 549 27.9% 29.8%
Cerezyme 127 -0.8% -1.6% 71 0.0% 46 2.2% 10 -15.4% 66 -4.3% 193 -2.0% -3.0%
Cerdelga 31 19.2% 19.2% 6 20.0% 23 15.0% 2 100.0% 0 - 31 19.2% 19.2%
Myozyme 170 8.3% 9.0% 87 6.0% 68 13.8% 15 0.0% 33 23.1% 203 10.4% 11.5%
Fabrazyme 166 8.6% 9.9% 41 5.0% 96 9.4% 29 11.5% 24 43.8% 190 12.0% 13.8%
Aldurazyme 37 0.0% 2.8% 19 0.0% 11 0.0% 7 0.0% 20 42.9% 57 12.0% 14.0%
Total
Rare
Disease
598 4.9% 4.9% 242 3.4% 273 6.8% 83 3.5% 154 10.2% 752 5.9% 6.4%
Taxotere 11 -25.0% -8.3% 1 0.0% 0 -100.
0%
10 -20.0% 33 0.0% 44 -6.5% -4.3%
Jevtana 93 10.8% 12.0% 38 5.6% 41 5.4% 14 50.0% 7 40.0% 100 12.5% 13.6%
Eloxatin 9 0.0% 28.6% 0 -100.
0%
0 - 9 16.7% 36 0.0% 45 0.0% 2.3%
Thymo-
globulin
59 3.6% 5.4% 10 -9.1% 44 7.7% 5 0.0% 17 30.8% 76 8.7% 10.1%
Mozobil 39 11.4% 11.4% 11 0.0% 24 0.0% 4 400.0% 1 -50.0% 40 8.1% 8.1%
Zaltrap 15 -6.3% -6.3% 13 8.3% 2 -33.3% 0 -100.0% 3 200.0% 18 5.9% 5.9%
Total
Oncology
282 3.8% 6.0% 86 2.4% 148 0.0% 48 20.5% 101 6.2% 383 4.4% 5.5%
Dupixent 26 - - 0 - 26 - 0 - 0 - 26 - -
Kevzara 1 - - 0 - 1 - 0 - 0 - 1 - -
Total
Immu-
nology
27 - - 0 - 27 - 0 - 0 - 27 - -
Sanofi
Genzyme
(Specialty
Care)
1,439 14.3% 15.6% 489 12.0% 796 16.7% 154 9.9% 272 9.7% 1,711 13.5% 14.6%
Lantus 935 -24.4% -23.0% 194 -14.0% 660 -28.1% 81 -13.2% 262 5.6% 1,197 -19.2% -18.3%
Apidra 70 -6.8% -4.1% 32 0.0% 27 -13.3% 11 -9.1% 23 15.0% 93 -2.2% 0.0%
Amaryl 16 -15.8% -15.8% 6 -25.0% 0 - 10 -18.2% 69 -2.7% 85 -5.4% -8.6%
Insuman 20 -8.7% -13.0% 20 -9.1% 0 - 0 0.0% 8 -27.3% 28 -14.7% -17.6%
Soliqua 5 - - 0 - 5 - 0 - 0 - 5 - -
Toujeo 191 34.
3%
36.
4%
54 100.
0%
122 12.3% 15 114.
3%
19 1700.
0%
210 46.
1%
48.
9%
Total
Diabetes
1,264 -17.1% -15.7% 325 -3.0% 814 -23.0% 125 -6.3% 383 8.4% 1,647 -12.2% -11.3%
Multaq 81 -3.6% -2.4% 11 -8.3% 71 -1.4% -1 -100.0% 2 0.0% 83 -3.6% -1.2%
Praluent 41 90.5% 95.2% 11 233.3% 29 61.1% 1 - 1 - 42 95.2% 100.0%
Total
Cardio-
vascular
122 15.4% 17.3% 22 40.0% 100 11.4% 0 0.0% 3 100.0% 125 16.2% 19.0%
Diabetes
&
Cardio-
vascular
1,386 -15.0% -13.5% 347 -1.1% 914 -20.3% 125 -6.2% 386 8.6% 1,772 -10.7% -9.7%
Plavix 385 -0.3% -1.8% 39 -9.3% 0 - 80 -26.2% 266 12.8% 385 -0.3% -1.8%
Lovenox 402 -2.4% -2.9% 243 -7.3% 14 0.0% 22 -8.0% 123 9.7% 402 -2.4% -2.9%
Renagel/
Renvela
248 16.8% 19.2% 19 -14.3% 209 20.0% 10 57.1% 10 0.0% 248 16.8% 19.2%
Aprovel 190 9.1% 8.6% 29 -12.1% 3 50.0% 46 34.3% 112 6.7% 190 9.1% 8.6%
Allegra 34 -12.8% -12.8% 4 0.0% 0 - 30 -13.9% 0 - 34 -12.8% -12.8%
Myslee/
Ambien/
Stilnox
64 -19.2% -17.9% 10 -9.1% 13 -50.0% 28 -6.7% 13 0.0% 64 -19.2% -17.9%
Synvisc/
Synvisc
One
116 4.6% 6.4% 9 0.0% 91 7.1% 4 -40.0% 12 9.1% 116 4.6% 6.4%
Depakine 109 6.7% 4.8% 41 0.0% 0 - 2 33.3% 66 10.0% 109 6.7% 4.8%
Tritace 62 -1.6% -1.6% 39 -2.6% 0 - 1 -50.0% 22 4.5% 62 -1.6% -1.6%
Lasix 36 -16.3% -16.3% 19 0.0% 0 - 4 -60.0% 13 -7.1% 36 -16.3% -16.3%
Targocid 35 -7.9% -7.9% 16 -15.8% 0 - 2 100.0% 17 -5.6% 35 -7.9% -7.9%
Other
Rx
Drugs
878 -8.5% -8.0% 413 -5.4% 55 -31.3% 97 -10.1% 313 -6.6% 878 -8.5% -8.0%
Total
Esta-
blished
Rx
Products
2,559 -2.3% -2.2% 881 -6.3% 385 1.1% 326 -10.6% 967 3.5% 2,559 -2.3% -2.2%
Generics 442 -8.0% -6.8% 190 -7.3% 32 -28.9% 31 45.0% 189 -9.4% 442 -8.0% -6.8%
Total
Emer-
ging
Markets
Specialty
Care
272 9.7% 9.7% 0 - 0 - 0 - 272 9.7% 0    
Total
Emer-
ging
Markets
Diabetes
&
Cardio-
vascular
386 8.6% 7.5% 0 - 0 - 0 - 386 8.6% 0.0%    
General
Medicines
&
Emer-
ging
Markets
3,659 -1.2% -1.1% 1,071 -6.4% 417 -2.1% 357 -7.6% 1,814 3.9% 3,001 -3.2% -2.9%
Allergy,
Cough
and
Cold
255 42.6% 44.9% 59 118.5% 88 13.3% 29 150.0% 79 24.2% 255 42.6% 44.9%
Pain 297 36.4% 38.8% 113 20.2% 46 9.8% 31 650.0% 107 38.7% 297 36.4% 38.8%
Digestive 239 84.9% 89.7% 76 66.7% 50 600.0% 16 - 97 24.3% 239 84.9% 89.7%
Nutritional 170 54.2% 58.9% 30 30.4% 1 0.0% 66 65.0% 73 58.1% 170 54.2% 58.9%
Consumer
Healthcare
1,163 42.5% 45.4% 308 44.6% 293 24.0% 161 133.3% 401 33.9% 1,163 42.5% 45.4%
   
Total
Pharma-
ceuticals
7,647 3.2% 4.1% 2,215 3.2% 2,420 -2.9% 797 9.6% 2,215 8.2% 7,647 3.2% 4.1%
   
Polio/
Pertussis/
Hib
469 37.2% 38.3% 83 140.0% 92 2.3% 39 2.6% 255 41.6% 469 37.2% 38.3%
Adult
Booster
Vaccines
115 11.5% 10.6% 29 158.3% 76 -1.3% 5 -16.7% 5 -50.0% 115 11.5% 10.6%
Meningitis/
Pneumonia
195 38.1% 40.3% 0 -100.0% 148 39.0% 20 280.0% 27 3.8% 195 38.1% 40.3%
Influenza
Vaccines
98 0.0% 2.1% 0 - 0 - 9 -40.0% 89 7.4% 98 0.0% 2.1%
Travel
and
other
Endemic
Vaccines
113 10.9% 11.9% 21 162.5% 42 -8.9% 14 25.0% 36 -2.8% 113 10.9% 11.9%
Dengue 1 0.0% 0.0% 0 - 0 - 0 - 1 0.0% 1 0.0% 0.0%
Vaccines 1,016 26.2% 27.5% 135 140.4% 378 12.7% 89 17.3% 414 22.2% 1,016 26.2% 27.5%
Total
Company
8,663 5.5% 6.4% 2,350 6.8% 2,798 -1.0% 886 10.3% 2,629 10.2% 8,663 5.5% 6.4%
                           

2017 first-half net sales by GBU, franchise, geographic region and product

                 
H1
2017
( million)
Total
GBUs
%
CER
%
re-
ported
Eu-
rope
%
CER
United
States
%
CER
Rest
of the
World
%
CER
Emer-
ging
Mar-
kets
%
CER
Total
Fran-
chises
%
CER
%
re-
ported
Aubagio 777 31.5% 34.4% 205 33.1% 544 30.7% 28 35.0% 19 25.0% 796 31.3% 34.0%
Lemtrada 238 26.1% 26.6% 92 26.7% 130 23.5% 16 45.5% 11 25.0% 249 26.0% 27.0%
Total
MS
1,015 30.2% 32.5% 297 31.0% 674 29.2% 44 38.7% 30 25.0% 1,045 30.0% 32.3%
Cerezyme 253 -1.6% -0.8% 139 -1.4% 92 1.1% 22 -12.5% 116 -7.1% 369 -3.4% -3.1%
Cerdelga 62 24.5% 26.5% 11 37.5% 48 20.5% 3 50.0% 0 - 62 24.5% 26.5%
Myozyme 333 9.6% 10.3% 169 5.5% 135 15.9% 29 7.7% 60 23.9% 393 11.5% 12.9%
Fabrazyme 324 10.4% 12.1% 81 6.5% 189 11.6% 54 12.5% 43 48.1% 367 13.6% 16.1%
Aldurazyme 72 0.0% 1.4% 38 0.0% 22 0.0% 12 0.0% 37 37.0% 109 10.2% 11.2%
Total
Rare
Disease
1,187 5.9% 7.1% 473 3.0% 547 9.5% 167 3.2% 277 10.6% 1,464 6.7% 8.2%
Taxotere 21 -32.1% -25.0% 2 0.0% 1 -50.0% 18 -33.3% 70 10.9% 91 -2.2% -1.1%
Jevtana 182 7.8% 9.0% 75 5.6% 81 4.0% 26 28.6% 15 27.3% 197 9.0% 10.7%
Eloxatin 17 -25.0% -15.0% 2 0.0% 0 - 15 -27.8% 73 12.1% 90 3.5% 4.7%
Thymo-
globulin
116 5.6% 8.4% 20 0.0% 85 7.9% 11 0.0% 32 18.5% 148 8.2% 10.4%
Mozobil 77 11.8% 13.2% 22 4.8% 49 6.8% 6 133.3% 3 -25.0% 80 9.7% 11.1%
Zaltrap 30 -6.3% -6.3% 26 8.3% 4 -42.9% 0 -100.0% 4 100.0% 34 0.0% 0.0%
Total
Oncology
589 6.9% 9.1% 174 5.4% 329 11.6% 86 -5.6% 206 13.8% 795 8.6% 10.3%
Dupixent 26 - - 0 - 26 - 0 - 0 - 26 - -
Kevzara 1 - - 0 - 1 - 0 - 0 - 1 - -
Total
Immunology
27 - - 0 - 27 - 0 - 0 - 27 - -
Sanofi
Genzyme
(Specialty
Care)
2,818 14.9% 16.7% 944 10.9% 1,577 19.8% 297 4.3% 513 12.7% 3,331 14.5% 16.3%  
Lantus 1,908 -21.6% -19.9% 393 -14.4% 1,350 -24.6% 165 -11.2% 515 7.5% 2,423 -16.7% -15.3%
Apidra 144 2.2% 4.3% 67 6.3% 56 -1.8% 21 0.0% 47 17.5% 191 5.6% 7.3%
Amaryl 32 -11.1% -11.1% 11 -31.3% 1 0.0% 20 5.3% 142 2.8% 174 0.0% -3.9%
Insuman 41 -6.8% -6.8% 40 -7.0% 1 0.0% 0 - 14 -31.8% 55 -15.2% -16.7%
Soliqua 9 - - 0 - 9 - 0 - 0 - 9 - -
Toujeo 367 47.7% 51.0% 100 117.
4%
237 25.0% 30 123.
1%
35 3000.
0%
402 59.8% 64.8%
Total
Diabetes
2,554 -13.8% -12.0% 651 -3.0% 1,653 -19.1% 250 -0.8% 756 10.2% 3,310 -9.2% -7.8%
Multaq 177 3.6% 6.0% 22 -4.3% 154 4.2% 1 100.0% 4 0.0% 181 3.5% 6.5%
Praluent 74 118.2% 124.2% 19 216.7% 53 92.6% 2 - 2 - 76 124.2% 130.3%
Total
Cardio-
vascular
251 22.5% 25.5% 41 41.4% 207 18.2% 3 200.0% 6 66.7% 257 23.2% 26.6%
Diabetes
&
Cardio-
vascular
2,805 -11.4% -9.6% 692 -1.1% 1,860 -16.1% 253 0.0% 762 10.4% 3,567 -7.5% -6.0%  
Plavix 765 -1.0% -1.9% 78 -8.2% 0 -100.0% 159 -27.0% 528 11.8% 765 -1.0% -1.9%
Lovenox 817 -0.1% -0.1% 500 -4.4% 29 -3.4% 45 -6.4% 243 11.9% 817 -0.1% -0.1%
Renagel/
Renvela
494 9.0% 11.8% 37 -14.0% 416 11.0% 19 26.7% 22 10.0% 494 9.0% 11.8%
Aprovel 383 11.0% 11.3% 60 -9.1% 6 0.0% 91 45.9% 226 7.6% 383 11.0% 11.3%
Allegra 102 -13.2% -10.5% 6 20.0% 0 - 96 -14.7% 0 - 102 -13.2% -10.5%
Myslee/
Ambien/
Stilnox
137 -10.8% -7.4% 20 -9.1% 28 -30.8% 57 -8.3% 32 11.1% 137 -10.8% -7.4%
Synvisc/
Synvisc
One
206 2.0% 4.6% 17 0.0% 158 2.0% 8 14.3% 23 0.0% 206 2.0% 4.6%
Depakine 221 8.3% 7.3% 81 1.2% 0 - 6 0.0% 134 13.6% 221 8.3% 7.3%
Tritace 124 0.8% -0.8% 78 -2.5% 0 - 2 50.0% 44 4.5% 124 0.8% -0.8%
Lasix 71 -7.8% -7.8% 37 -2.6% 0 - 6 -58.3% 28 7.4% 71 -7.8% -7.8%
Targocid 72 -4.0% -4.0% 35 -10.3% 0 - 3 0.0% 34 3.0% 72 -4.0% -4.0%
Other
Rx
Drugs
1,807 -5.1% -4.0% 839 -3.4% 113 -27.9% 196 -3.7% 659 -2.4% 1,807 -5.1% -4.0%
Total
Estab-
lished
Rx
Products
5,199 -0.9% -0.2% 1,788 -4.2% 750 -1.9% 688 -8.4% 1,973 5.8% 5,199 -0.9% -0.2%
Generics 910 -5.0% -2.5% 388 -5.3% 69 -28.7% 64 34.8% 389 -3.7% 910 -5.0% -2.5%
Total
Emer-
ging
Markets
Specialty
Care
513 12.7% 14.0%             513 12.7%      
Total
Emer-
ging
Markets
Diabetes
&
Cardio-
vascular
762 10.4% 10.1%             762 10.4%      
General
Medicines
&
Emer-
ging
Markets
7,384 0.5% 1.4% 2,176 -4.4% 819 -4.9% 752 -5.8% 3,637 6.6% 6,109 -1.5% -0.5%
Allergy,
Cough
and
Cold
669 52.1% 55.6% 166 163.5% 242 13.0% 91 166.7% 170 30.7% 669 52.1% 55.6%
Pain 621 40.8% 44.8% 252 33.9% 90 13.0% 60 625.0% 219 32.9% 621 40.8% 44.8%
Digestive 468 69.4% 74.6% 161 62.6% 94 550.0% 28 1300.0% 185 13.7% 468 69.4% 74.6%
Nutritional 334 45.0% 51.8% 63 23.5% 2 0.0% 129 65.3% 140 41.3% 334 45.0% 51.8%
Consumer
Health-
care
2,504 42.6% 46.9% 714 57.1% 641 21.1% 344 142.3% 805 27.2% 2,504 42.6% 46.9%
   
Total
Pharma-
ceuticals
15,511 5.3% 6.9% 4,526 5.7% 4,897 -0.6% 1,646 11.3% 4,442 9.7% 15,511 5.3% 6.9%
   
Polio/
Pertussis/
Hib
901 41.3% 43.7% 140 143.1% 219 43.9% 83 27.0% 459 26.3% 901 41.3% 43.7%
Adult
Booster
Vaccines
194 4.3% 5.4% 46 84.6% 121 -7.1% 13 0.0% 14 -27.8% 194 4.3% 5.4%
Meningitis/
Pneumonia
290 8.8% 11.1% 1 -66.7% 219 5.4% 22 162.5% 48 2.2% 290 8.8% 11.1%
Influenza
Vaccines
136 14.7% 17.2% 0 -100.0% 3 0.0% 19 -5.0% 114 20.7% 136 14.7% 17.2%
Travel
and
other
Endemic
Vaccines
219 17.4% 19.0% 43 175.0% 71 0.0% 28 21.7% 77 -1.3% 219 17.4% 19.0%
Dengue 18 -5.0% -10.0% 0 - 0 - 0 - 18 -5.0% 18 -5.0% -10.0%
Vaccines 1,800 24.5% 26.6% 235 126.7% 665 13.0% 170 26.2% 730 17.3% 1,800 24.5% 26.6%
Total
Company
17,311 7.0% 8.7% 4,761 8.6% 5,562 0.9% 1,816 12.6% 5,172 10.7% 17,311 7.0% 8.7%
                               

Appendix 2: Business net income statement

Second Quarter
2017
Pharma-
ceuticals
Vaccines Others Total
Group
million Q2
2017
Q2
2016
Change Q2
2017
Q2
2016
Change Q2
2017
Q2
2016
Q2
2017
Q2
2016
Change
Net
sales
7,647 7,346 4.1% 1,016 797 27.5%  

 
  8,663 8,143 6.4%
Other
revenues
73 68 7.4% 197 97 103.1%     270 165 63.6%
Cost of
sales
(2,168) (2,046) 6.0% (629) (477) 31.9%     (2,797) (2,523) 10.9%
As % of net sales (28.4%) (27.9%)   (61.9%) (59.8%)       (32.3%) (31.0%)  
Gross
profit
5,552 5,368 3.4% 584 417 40.0%     6,136 5,785 6.1%
As %
of net sales
72.6% 73.1%   57.5% 52.3%       70.8% 71.0%  
Research and
development
expenses
(1,203) (1,138) 5.7% (155) (141) 9.9%     (1,358) (1,279) 6.2%
As %
of net sales
(15.7%) (15.5%)   (15.3%) (17.7%)       (15.7%) (15.7%)  
Selling and
general
expenses
(2,338) (2,215) 5.6% (230) (182) 26.4%     (2,568) (2,397) 7.1%
As %
of net sales
(30.6%) (30.2%)   (22.6%) (22.8%)       (29.6%) (29.4%)  
Other
current
operating income
/expenses
53 3   5 (1)   10 (25) 68 (23)  
Share of profit/loss
of associates*
and
joint-ventures
52 28   (1) 2       51 30  
Net income
attributable
to non-
controlling interests
(30) (23)   -  -       (30) (23)  
Business
operating
income
2,086 2,023 3.1% 203 95 113.7% 10 (25) 2,299 2,093 9.8%
As %
of net sales
27.3% 27.5%   20.0% 11.9%       26.5% 25.7%  
  Financial
income and expenses
(60) (74)  
Income
tax expense
(543) (467)  
Tax
rate**
24.5% 23.2%  
Business net income excl.
Animal Health business
1,696 1,552 9.3%
As %
of net sales
19.6% 19.1%  
Business Net Income of
Animal Health business
- 128  
       
Business
Net Income
1,696 1,680 1.0%
       
Business earnings/
share (in euros) ***
1.35 1.31 3.1%

* 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 1,258.2 million in the second quarter of 2017 and 1,286.8 million in the second quarter of 2016.

First Half
2017
Pharma-
ceuticals
Vaccines Others Total
Group
million H1
2017
H1
2016
Change H1
2017
H1
2016
Change H1
2017
H1
2016
H1
2017
H1
2016
Change
Net
sales
15,511 14,504 6.9% 1,800 1,422 26.6%     17,311 15,926 8.7%
Other
revenues
149 122 22.1% 370 188 96.8%     519 310 67.4%
Cost of
sales
(4,363) (4,143) 5.3% (1,131) (827) 36.8%     (5,494) (4,970) 10.5%
As %
of net sales
(28.1%) (28.6%)   (62.8%) (58.2%)       (31.7%) (31.2%)  
Gross
profit
11,297 10,483 7.8% 1,039 783 32.7%     12,336 11,266 9.5%
As %
of net sales
72.8% 72.3%   57.7% 55.1%       71.3% 70.7%  
Research and
development
expenses
(2,373) (2,246) 5.7% (294) (268) 9.7%     (2,667) (2,514) 6.1%
As %
of net sales
(15.3%) (15.5%)   (16.3%) (18.8%)       (15.4%) (15.8%)  
Selling and general
expenses
(4,609) (4,261) 8.2% (437) (348) 25.6%     (5,046) (4,609) 9.5%
As %
of net sales
(29.7%) (29.4%)   (24.3%) (24.5%)       (29.1%) (28.9%)  
Other
current
operating income/
expenses
122 110   2 (1)   (22) (39) 102 70  
Share of profit/loss
of associates* and
joint-
ventures
82 44   (1) 9       81 53  
Net income
attributable
to non-
controlling
interests
(65) (50)   -  -       (65) (50)  
Business
operating
income
4,454 4,080 9.2% 309 175 76.6% (22) (39) 4,741 4,216 12.5%
As %
of net
sales
28.7% 28.1%   17.2% 12.3%       27.4% 26.5%  
  Financial income
and expenses
(123) (191)  
Income tax expense (1,127) (922)  
Tax
rate**
24.5% 22.9%  
Business net income excl.
Animal Health
business
3,491 3,103 12.5%
As % of
net sales
20.2% 19.5%  
Business Net Income of
Animal Health business
- 299  
       
Business
Net Income
3,491 3,402 2.6%
       
Business earnings/
share (in euros) ***
2.77 2.64 4.9%

* 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 1,260.3 million in the first semester of 2017 and 1,287.6 million in the first semester of 2016.

Appendix 3: Consolidated income statements

million Q2 2017 (1) Q2 2016 (1) H1 2017 (1) H1 2016 (1)
Net sales 8,663             8,143   17,311           15,926  
Other revenues 270 165 519 310
Cost of sales (2,885) (2,523) (5,670) (4,970)
Gross profit 6,048 5,785 12,160 11,266
Research and development expenses (1,358) (1,279) (2,667) (2,514)
Selling and general expenses (2,568) (2,397) (5,046) (4,609)
Other operating income 113 48 173 265
Other operating expenses (45) (71) (71) (195)
Amortization of intangible assets (487) (433) (990) (877)
Impairment of intangible assets (12) (52) (12) (52)
Fair value remeasurement of contingent consideration (64) (38) (100) (67)
Restructuring costs and similar items (245) (127) (364) (627)
Other gains and losses and litigation (7) - (7) -
Operating income 1,375 1,436 3,076 2,590
Financial expenses (107) (112) (218) (241)
Financial income 47 38 95 50
Income before tax and associates and joint ventures 1,315 1,362 2,953 2,399
Income tax expense (274) (380) (610) (497)
Share of profit/loss of associates and joint ventures 32 5 38 98
Net income excluding the exchanged/held-for-exchange Animal Health business 1,073 987 2,381 2,000
Net income from the exchanged/held-for-exchange Animal Health business (6) 186 4,421 286
Net income 1,067 1,173 6,802 2,286
Net income attributable to non-controlling interests 30 15 64 41
Net income attributable to equity holders of Sanofi 1,037 1,158 6,738 2,245
Average number of shares outstanding (million) 1,258.2 1,286.8 1,260.3 1,287.6
Earnings per share (in euros) excluding the exchanged/held-for-exchange Animal Health business 0.83 0.76 1.84 1.52
IFRS earnings per share (in euros) 0.82 0.90 5.35 1.74

(1) Animal Health results and gain on disposal are reported 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 Q2 2017 Q2 2016 Change
Net income attributable to equity holders of Sanofi 1,037 1,158 (10.4%)
Amortization of intangible assets(1) 487 433  
Impairment of intangible assets 12 52  
Fair value remeasurement of contingent
consideration
64 38  
Expenses arising from the impact of acquisitions on inventories 88 -  
Restructuring costs and similar items 245 127  
Other gains and losses, and litigation(2) 7 -  
Tax effect of items listed above: (380) (210)  
     Amortization of intangible assets (163) (151)  
     Impairment of intangible assets (4) (16)  
     Fair value remeasurement of contingent consideration (25) (4)  
     Expenses arising from the impact of acquisitions on
     inventories
(28) -  
     Restructuring costs and similar items (83) (39)  
     Other tax effects (77) -  
Other tax items 111 113  
Share of items listed above attributable to non-controlling interests - (8)  
Restructuring costs of associates and joint-ventures, and expenses arising from the impact of acquisitions on associates and joint-ventures 19 16  
Animal Health items(3) 6 (58)  
Other Sanofi Pasteur MSD items(4) - 19  
Business net income 1,696 1,680 1.0%
IFRS earnings per share(5) (in euros) 0.82 0.90  

(1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations:  453 million in the second quarter of 2017 and 399 million in the second quarter of 2016.
(2) In 2017, carve-out costs related to the EU Generics divestment process.
(3) In 2016, includes the following items: impact of the discontinuation of depreciation and impairment of Property, Plant & Equipment starting at IFRS 5 application (Non-current assets held for sale and discontinued operations), impact of the amortization and impairment of intangible assets until IFRS 5 application, costs incurred as a result of the divestment as well as tax effect of these items.
(4) In 2016, includes the following items: impact of the discontinuation of the equity accounting of the Sanofi Pasteur MSD business net income since the announcement by Sanofi and Merck of their intent to end their joint vaccine operations in Europe.
(5) Based on an average number of shares outstanding of 1,258.2 million in the second quarter of 2017 and 1,286.8 million in the second quarter of 2016.

 

million
H1 2017 H1 2016 Change
Net income attributable to equity holders of Sanofi 6,738 2,245 200.1%
Amortization of intangible assets(1) 990 877  
Impairment of intangible assets 12 52  
Fair value remeasurement of contingent
consideration
100 67  
Expenses arising from the impact of acquisitions on inventories 176 -  
Restructuring costs and similar items 364 627  
Other gains and losses, and litigation(2) 7 -  
Tax effect of items listed above: (628) (548)  
     Amortization of intangible assets (345) (307)  
     Impairment of intangible assets (4) (16)  
     Fair value remeasurement of contingent consideration (31) (15)  
     Expenses arising from the impact of acquisitions on
    inventories
(56) -  
     Restructuring costs and similar items (126) (210)  
     Other tax effects (66) -  
Other tax items 111 113  
Share of items listed above attributable to non-controlling interests (1) (9)  
Restructuring costs of associates and joint-ventures, and expenses arising from the impact of acquisitions on associates and joint-ventures 43 (54)  
Animal Health items(3) (4,421) 13  
Other Sanofi Pasteur MSD items (4) - 19  
Business net income 3,491 3,402 2.6%
IFRS earnings per share(5) (in euros) 5.35 1.74  

(1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations:  919 million in the first semester of 2017 and 809 million in the first semester of 2016.
(2) In 2017, carve-out costs related to the EU Generics divestment process.
(3) In 2017, net gain resulting from the divestment of the Animal Health business. In 2016, includes the following items: impact of the discontinuation of depreciation and impairment of Property, Plant & Equipment starting at IFRS 5 application (Non-current assets held for sale and discontinued operations), impact of the amortization and impairment of intangible assets until IFRS 5 application, costs incurred as a result of the divestment as well as tax effect of these items.
(4) In 2016, includes the following items: impact of the discontinuation of the equity accounting of the Sanofi Pasteur MSD business net income since the announcement by Sanofi and Merck of their intent to end their joint vaccine operations in Europe.
(5) Based on an average number of shares outstanding of 1,260.3 million in the first semester of 2017 and 1,287.6 million in the first semester of 2016.

Appendix 5: Change in net debt

million H1 2017 H1 2016
Business net income 3,491 3,402
Depreciation amortization and impairment of property, plant and equipment and software 604 600
Net gains and losses on disposals of non-current assets, net of tax (79) (27)
Other non-cash items 156 (324)
Operating cash flow before changes in working capital (1)/(2) 4,172 3,651
Changes in working capital (1) (1,185) (574)
Acquisitions of property, plant and equipment and software (688) (645)
Free cash flow (1)/(2) 2,299 2,432
Acquisitions of intangibles, excluding software (285) (556)
Acquisitions of investments, including assumed debt (274) (369)
Restructuring costs and similar items paid (438) (347)
Proceeds from disposals of property, plant and equipment, intangibles, and other non-current assets, net of tax 313 260
Issuance of Sanofi shares 99 17
Dividends paid to shareholders of Sanofi (3,710) (3,759)
Acquisition of treasury shares (1,698) (1,403)
Transactions with non-controlling interests including dividends (48) (9)
Foreign exchange impact 290 12
Net cash flow from the swap between BI-CHC and Sanofi animal Health business 4,349 -
Other items (154) (25)
Change in net debt 743 (3,747)

(1) Excluding restructuring costs and similar items.
(2) Excluding Animal Health business for the 2016 comparative period.

Appendix 6: Simplified consolidated balance sheet

ASSETS
million
06/30/17 12/31/16 LIABILITIES
million
06/30/17 12/31/16
      Equity attributable to equity-holders of Sanofi 57,631 57,554
      Equity attributable to non-controlling interests 161 170
      Total equity 57,792 57,724
      Long-term debt 15,186 16,815
Property, plant and equipment 9,633 10,019 Non-current liabilities related to business combinations and to non-controlling interests 1,287 1,378
Intangible assets (including goodwill) 54,813 51,166 Provisions and other non-current liabilities 8,412 8,834
Non-current financial assets, investments in associates, and deferred tax assets

 
10,325 10,379 Deferred tax liabilities 2,128 2,292
Non-current assets 74,771 71,564 Non-current liabilities 27,013 29,319
      Accounts payable and other current liabilities 13,580 14,472
Inventories, accounts receivable and other current assets 16,194 16,414 Current liabilities related to business combinations and  to non-controlling interests 234 198
Cash and cash equivalents 10,877 10,273 Short-term debt and current portion of long-term debt 3,241 1,764
Current assets 27,071 26,687 Current liabilities 17,055 16,434
Assets held for sale or exchange 28 6,421 Liabilities related to assets held for sale or exchange 10 1,195
Total ASSETS 101,870 104,672 Total LIABILITIES & EQUITY 101,870 104,672

Appendix 7: currency sensitivity

2017 Business EPS currency sensitivity

Currency Variation Business EPS Sensitivity
U.S. Dollar -0.05 USD/EUR +EUR 0.13
Japanese Yen +5 JPY/EUR -EUR 0.02
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 Q2 2017 sales

Currency Q2 2017
US $ 33.3%
Euro 24.7%
Chinese Yuan 6.2%
Japanese Yen 4.9%
Brazilian Real 3.0%
British Pound 2.1%
Russian Ruble 1.7%
Australian $ 1.7%
Mexican Peso 1.5%
Canadian $ 1.4%
Others 19.5%

Currency average rates

  Q2 2016 Q2 2017 Change
/$ 1.13 1.10 -2.6%
/Yen 121.98 122.15 +0.1%
/Yuan 7.38 7.54 +2.2%
/Real 3.96 3.54 -10.8%
/Ruble 74.35 62.87 -15.4%

Appendix 8: R&D Pipeline

: New Molecular Entity
: Registration Study

Registration

 

Dupixent
Anti-IL4Ralpha mAb
Atopic dermatitis, EU

 

Dengvaxia(1)
Mild-to-severe
dengue fever vaccine

N
SAR342434
insulin lispro
Type 1+2 diabetes
PR5i
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine, U.S.

(1) Approved in 18 countries to date

Phase 3

 

dupilumab
Anti-IL4Ralpha mAb
Asthma, Nasal polyposis

N
sotagliflozin
Oral SGLT-1&2 inhibitor
Type 1 & type 2 diabetes

 
N
isatuximab
Anti-CD38 naked mAb
Relapsed refractory multiple myeloma

Clostridium difficile
Toxoid vaccine
N
SAR439684
PD-1 inhibitor
1st line NSCLC

VaxiGrip QIV IM
Quadrivalent inactivated
influenza vaccine (6-35 months)

N
patisiran
siRNA inhibitor targeting TTR
Hereditary ATTR amyloidosis

Pediatric pentavalent vaccine
DTP-Polio-Hib
Japan
N
GZ402666
neo GAA
Pompe disease

Men Quad TT
2nd generation meningococcal
ACYW conjugate vaccine 
N
fitusiran
siRNA targeting Anti-Thrombin
Hemophilia

 

Phase 2

 

dupilumab
Anti-IL4Ralpha mAb
Eosinophilic oesophagitis

N
efpeglenatide
Long-acting GLP-1 receptor agonist
Type 2 diabetes

Rabies VRVg
Purified vero rabies vaccine

N
SAR156597
 IL4/IL13 Bi-specific mAb
IPF, Systemic Scleroderma

N
SAR425899
GLP-1R/GCGR dual agonist
Type 2 diabetes

Tuberculosis
Recombinant subunit vaccine

N
GZ389988
 TRKA antagonist
Osteoarthritis

R
SAR439684
PD-1 inhibitor
Advanced CSCC (Skin cancer)


Fluzone
QIV HD
Quadrivalent inactivated
influenza vaccine - High dose
N
SAR100842
LPA1 receptor antagonist
Systemic sclerosis


SAR439684

PD-1 inhibitor
Advanced BCC


Adacel+
Tdap booster
 

sarilumab
Anti-IL6R mAb
Uveitis

isatuximab
Anti-CD38 naked mAb
Acute lymphoblastic leukemia

Shan 6
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine
N
SAR422459
ABCA4 gene therapy
Stargardt disease

N
SAR566658
Maytansin-loaded anti-CA6 mAb
Solid tumors


HIV

Viral vector prime & rgp120 boost vaccine
N - R
olipudase alfa
rhASM Deficiency
Acid sphingomyelinase deficiency(1)

N
SAR439152
Myosin inhibitor
Hypertrophic cardiomyopathy

 

SP0232(2)
Respiratory syncytial virus mAb

 
N
venglustat
Oral GCS inhibitor
Gaucher related Parkinson's disease,
Gaucher disease type 3, Fabry disease
N - R
Combination
ferroquine / OZ439
Antimalarial

 

 

(1) Also known as Niemann Pick type B
(2) Also known as MEDI8897

Phase 1

N
SAR440340
Anti-IL33 mAb
Asthma & COPD

 
N
SAR408701
Maytansin-loaded anti-CEACAM5 mAb
Solid tumors

N
SAR440181(1)
DCM1 Myosin activation
Cardiovascular indication
N
SAR439794
TLR4 agonist
Peanut allergy

 
N
SAR428926
Maytansin-loaded anti-Lamp1 mAb
Cancer

 
N
SAR247799
S1P1 agonist
Cardiovascular indication
N
GZ402668
GLD52 (anti-CD52 mAb)
Relapsing multiple sclerosis

 
N
SAR439459
TGFb inhibition mAb
Metastatic melanoma

 
N
SAR407899
rho kinase
Microvascular angina
N
UshStat
Myosin 7A gene therapy
Usher syndrome 1B

 
N
SAR438335
GLP-1R/GIPR dual agonist
Type 2 diabetes

 
Herpes Simplex Virus Type 2
HSV-2 vaccine
N
SAR228810
Anti-protofibrillar AB mAb
Alzheimer's disease

 
N
SAR341402
Rapid acting insulin
Diabetes
Zika
Inactivated Zika vaccine
(1) Also known as MYK491   Respiratory syncytial virus
Infants

Appendix 9: Expected R&D milestones

Products Expected milestones Timing
Dupixent Start of Phase 3 trial in Atopic dermatitis in 6-11 year-olds Q3 2017
Fluzone QIV HD Start of Phase 3 trial Q3 2017
VaxiGrip QIV IM (6-35 months) EU regulatory submission Q3 2017
patisiran Phase 3 results in Hereditary ATTR amyloidosis Q3 2017
dupilumab Phase 3 results in Asthma in adult/adolescent patients Q4 2017
dupilumab U.S. regulatory submission in Asthma in adult/adolescent patients Q4 2017
Dupixent Start of Phase 3 trial in Atopic dermatitis in 6 months to 5 year-olds Q4 2017
efpeglenatide Start of Phase 3 trial in type-2 Diabetes Q4 2017
sotagliflozin Start of Phase 3 trials in combination therapies in type-2 Diabetes H2 2017
isatuximab Start of additional Phase 3 trials in Multiple myeloma and additional indications H2 2017
SAR439684 (PD-1) Phase 2/3 to start in additional solid tumors H2 2017
Praluent ODYSSEY OUTCOMES top-line results Q1 2018
SAR439684 (PD-1) Phase 2 (registration) results in Cutaneous squamous cell carcinoma Q1 2018
GZ402668 (anti-CD52 mAb) Start of Phase 3 in Relapsing multiple sclerosis Q1 2018
dupilumab Start of Phase 3 trial in Eosinophilic oesophagitis Q1 2018
dupilumab EU regulatory submission in Asthma in adult/adolescent patients Q1 2018

Appendix 10: 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 second quarter and first half of 2017

million Q2 2017 H1 2017  
Net sales 8,663 17,311  
Effect of exchange rates (76) (270)  
Company sales at constant exchange rates 8,587 17,041  

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.
(2) In 2016, impact of discontinuation of depreciation and impairment of Property, Plant and Equipment starting at IFRS 5 application (non-current assets held for sales and discontinued operations), amortization and impairment of intangible assets until IFRS 5 application and costs incurred as a result of the divestment as well as tax effect of these items; and in 2017 gain on the disposal of the Animal Health business, net of tax.

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