July 30, 2015

Sanofi delivers solid sales and business EPS(1) growth in Q2 2015

 

Sanofi delivers solid sales and business EPS(1) growth in Q2 2015

Paris, July 30, 2015

Sanofi delivers solid sales and business EPS(1) growth in Q2 2015

Sales growth broad based across geographies and businesses

  • Group sales(2) increased 4.9% (+16.1% on a reported basis) to €9,378 million
  • Slightly lower Diabetes sales (-3.8%) consistent with previous quarter and significant U.S. market access already granted for Toujeo®
  • Genzyme delivered 26.6% growth; rare disease products increased 9.1% and the Multiple Sclerosis franchise sales more than doubled
  • Animal Health recorded another strong quarter (+14.2%) driven by NexGard®
  • Vaccines sales grew 8.6% led by influenza and booster vaccines
  • Emerging Markets(3) sales increased 7.5%


Strong financial performance

  • Business net income grew 4.2% at CER (+19.7% on a reported basis) to €1,840 million
  • Business EPS increased 5.1% at CER to €1.41 and grew 20.5% on a reported basis


Significant progress in advancing innovative products

  • Praluent® approved on July 24, in the U.S. and recommended for approval in the EU
  • Positive Phase III topline results announced for LixiLan in diabetes in July and sarilumab in rheumatoid arthritis in May
  • Phase IIIb ELIXA study results demonstrated cardiovascular safety of lixisenatide supporting the U.S. regulatory filing
  • Olipudase alfa for Niemann-Pick type B advanced to Phase II and Breakthrough Therapy  designation granted by FDA


New strategic collaboration with Regeneron in immuno-oncology

  • Collaboration includes a PD-1 inhibitor in Phase I and other immuno-oncology antibodies currently in Preclinical development, including LAG3, GITR and PD-L1


2015 financial guidance

  • The performance of the second quarter is in line with the full year guidance announced on February 5, 2015. Sanofi expects 2015 Business EPS(1) to be stable to slightly growing versus 2014(4) at constant average exchange rates, barring major unforeseen adverse events
  • In addition, the positive currency impact on 2015 full-year business EPS is estimated to be approximately +10%, under the assumption that exchange rates remain stable in the following two quarters at the average rates of June 2015

 

Sanofi Chief Executive Officer, Olivier Brandicourt commented:
“In the second quarter, Sanofi delivered solid growth on both the top and bottom lines that was consistent with our expectations. We continue to execute on multiple product launches and are excited about the recent approval of Praluent®. We are also investing in our commercial infrastructure, biologic capabilities and R&D programs including in immuno-oncology. Recently, we announced a new organizational structure which will be implemented beginning in January 2016 and will simplify and focus Sanofi to optimize future 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 10 for definitions of financial indicators). The consolidated income statement for Q2 2015 is provided in Appendix 4 and a reconciliation of business net income to IFRS net income reported in Appendix 3; (2) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 10 for a definition); (3) See page 8; (4) 2014 business EPS was €5.20

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2015 second-quarter and first-half key figures

  Q2 2015 Change
(reported)
Change
(CER)
H1 2015 Change
(reported)
Change
(CER)
Net sales €9,378m +16.1% +4.9% €18,188m +14.3% +3.6%
Business net income(1) €1,840m +19.7% +4.2% €3,566m +15.6% +2.9%
Business EPS(1) €1.41 +20.5% +5.1% €2.73 +16.7% +3.8%
IFRS net income reported €1,302m +67.6%   €2,325m +24.9%  
IFRS EPS reported €1.00 +69.5%   €1.78 +26.2%  

2015 second-quarter and first-half sales

Unless otherwise indicated, all sales growth figures in this press release are stated at constant exchange rates(1).

In the second quarter of 2015, sales of Sanofi increased 16.1% on a reported basis to €9,378 million. Exchange rate movements had a positive effect of 11.2 percentage points reflecting mainly the strength of the U.S. dollar against the Euro. At constant exchange rates, sales increased 4.9% reflecting the sustained strength of our diversified businesses.

First-half sales reached €18,188 million, an increase of 14.3% on a reported basis. Exchange rate movements had a favorable effect of 10.7 percentage points.

€ million Q2 2015
net sales
Change
(CER)
H1 2015
net sales
Change
(CER)
Pharmaceuticals   7,800   +3.7% 15,255 +3.0%
Diabetes 1,988   -3.8% 3,825 -3.5%
Genzyme 907   +26.6% 1,728 +28.6%
Consumer Healthcare (CHC) 890   +1.3% 1,869 +3.4%
Generics 520   +9.2% 998 +9.7%
Oncology 390   +3.6% 747 -1.9%
Established Rx Products 3,105   +3.1% 6,088 +0.8%
Vaccines   887   +8.6% 1,584 +2.5%
Animal Health   691   +14.2% 1,349 +13.9%
Total net sales   9,378   +4.9% 18,188 +3.6%

Pharmaceuticals

Second-quarter sales for Pharmaceuticals were €7,800 million, an increase of 3.7%, driven mainly by Genzyme and Generics, which were partially offset by lower sales of Diabetes. First-half sales for Pharmaceuticals grew 3.0% to €15,255 million.

  1. See Appendix 10 for definitions of financial indicators.

Diabetes

€ million Q2 2015
net sales
Change
(CER)
H1 2015
 ne
t sales
Change
(CER)
Lantus® 1,709 -5.8% 3,293 -5.4%
Amaryl® 109 0.0% 206 +0.5%
Apidra® 93 +11.7% 184 +11.2%
Insuman® 34 0.0% 67 +1.5%
BGM (Blood Glucose Monitoring) 16 0.0% 32 0.0%
Toujeo® 13 20
Lyxumia® 10 +50.0% 18 +54.5%
Afrezza® 2 3
Total Diabetes 1,988 -3.8% 3,825 -3.5%

Second-quarter sales of the Diabetes division were €1,988 million, a decrease of 3.8% reflecting lower sales of Lantus® in the U.S. as expected and in line with the previous quarter. In the U.S., sales of Diabetes were €1,134 million (down 14.0%) and accounted for 57% of worldwide Diabetes sales. Sales of Diabetes outside the U.S. were €854 million, an increase of 11.2% and represented 43% of worldwide Diabetes sales. First-half sales for the Diabetes division were €3,825 million down 3.5%.

Second-quarter sales of Lantus® were €1,709 million down 5.8%. In the U.S., sales of Lantus® decreased 15.4% to €1,086 million due to increased rebates granted to maintain favorable formulary positions with key payers. Sales of Lantus® outside the U.S. grew 13.0% over the period. In Emerging Markets, second-quarter sales of Lantus® were up 21.4% to €305 million, driven by Latin America, China and Middle East. In Western Europe, sales of the product were up 6.1% to €230 million over the period driven by double-digit growth in France and Germany. A biosimilar of Lantus® was launched in some small Eastern European markets in July. First-half sales of Lantus® reached €3,293 million, down 5.4%.

Toujeo®, a next-generation basal insulin, was launched in the U.S. market at the end of March and significant market access has already been achieved. Indeed, as of August, 73% of lives are covered by commercial plans and have unrestricted access to Toujeo®, including 45% of lives with preferred Tier 2 access. In Medicare Part D, 91% of lives are covered with unrestricted access to Toujeo®. Following EU approval in April, Toujeo® was launched in Germany, the Netherlands and some Nordic countries. Toujeo® was also recently approved in Japan, Canada and Australia. Total sales of the product were €13 million and €20 million in the second quarter and the first half of 2015, respectively.

Second-quarter sales of Amaryl® were stable at €109 million, of which €90 million were generated in Emerging Markets (up 1.3%). First-half sales of Amaryl® were relatively stable at €206 million.

Sales of Apidra® were up 11.7% to €93 million in the second quarter, driven by Emerging Markets (up 27.8% to €24 million). In Western Europe sales were up 8.3% (to €26 million), while in the U.S. sales of the product remained stable (at €34 million). First-half sales of Apidra® were up 11.2% to €184 million.

Second-quarter sales of Lyxumia® (lixisenatide) were €10 million. The results of the Phase IIIb ELIXA cardiovascular outcomes study of Lyxumia® were presented at American Diabetes Association’s 75th Scientific Sessions in June and were included in the U.S. New Drug Application for lixisenatide submitted at the end of July. First-half sales of Lyxumia® were €18 million.

Afrezza®, a new rapid-acting inhaled insulin therapy (partnered with MannKind), was launched in the U.S. in February 2015. Sales of the product were €2 million and €3 million in the second quarter and the first half of 2015, respectively.

Genzyme

€ million Q2 2015
net sales
Change
(CER)
H1 2015
net sales
Change
(CER)
Cerezyme® 199 +6.3% 388 +5.5%
Myozyme® / Lumizyme® 165 +14.3% 321 +16.5%
Fabrazyme® 146 +4.9% 287 +14.9%
Aldurazyme® 50 +4.4% 98 +7.0%
Cerdelga® 16 26  
Total Rare Diseases 647 +9.1% 1,260 +12.3%
Aubagio® 204 +80.4% 374 +84.0%
Lemtrada(TM) 56 ns 94 ns
Total Multiple Sclerosis 260 +118.4% 468 +118.3%
Total Genzyme 907 +26.6% 1,728 +28.6%

Sales of Genzyme increased 26.6% to €907 million in the second quarter sustained by the strong performance of Aubagio® and the launch progress of Lemtrada®. Genzyme recorded another quarter with double-digit sales growth in all territories; U.S. sales increased 37.0% to €398 million, Western Europe sales grew 24.9% to €265 million and Emerging Markets sales were up 18.0% to €162 million. First-half sales of Genzyme increased 28.6% to €1,728 million.

Second-quarter sales of Rare Diseases grew 9.1% to €647 million.

Sales of the Gaucher franchise grew 13.1% to €215 million in the second-quarter. Sales of Cerezyme® increased 6.3% to €199 million driven by strong performance in Emerging Markets (up 28.1% to €76 million). In the U.S., sales of Cerezyme® were down 11.1% reflecting the launch of Cerdelga®, the only first-line oral therapy for Gaucher disease type 1 patients. In the U.S., sales of the Gaucher franchise were up 15.6% to €64 million in the second quarter. First-half sales of Cerezyme® increased 5.5% to €388 million. Cerdelga® recorded sales of €16 million in the second quarter and €26 million in the first-half.

Sales of Fabrazyme® reached €146 million, an increase of 4.9% in the second quarter. The performance recorded by the product in the U.S. (up 9.1% to €76 million), Western Europe, (up 14.3% to €33 million) and the rest of the world (up 25.0% to €19 million) was partially offset by decreased sales in Emerging Markets (down 29.2% to €18 million) reflecting an unfavorable phasing effect in Brazil. First-half sales of Fabrazyme® increased 14.9% to €287 million.

Second-quarter sales of Myozyme®/Lumizyme® increased 14.3% to €165 million, largely driven by new patient accruals. In the U.S., growth (up 21.2% to €51 million) was partially due to the conversion of clinical study patients in late 2014. In Emerging Markets, sales were up 20.0% to €31 million. First-half sales of Myozyme®/Lumizyme® increased 16.5% to €321 million.

Sales of Multiple Sclerosis products increased 118.4% to €260 million in the second quarter.

For the first time, Aubagio® became Genzyme largest brand in terms of quarterly sales. Sales of Aubagio® grew 80.4% to €204 million driven by sales in the U.S. (up 59.7% to €142 million) and Western Europe (€46 million versus €21 million in the same period of 2014) with strong performance in France. First-half sales of Aubagio® increased 84.0% to €374 million.

Second-quarter sales of Lemtrada® were €56 million including €21 million in Western Europe (mainly in Germany and the UK) and €29 million in the U.S. where the product was introduced late last year. First-half sales of Lemtrada® were €94 million compared to €11 million in the first half of 2014.

Consumer Healthcare

€ million Q2 2015
net sales
Change
(CER)
H1 2015
net sales
Change
(CER)
Allegra® 116 +6.4% 258 +11.6%
Doliprane® 70 0.0% 155 -1.9%
Essentiale® 45 -18.2% 95 -12.4%
Lactacyd® 42 +12.5% 68 +5.3%
Enterogermina® 36 -5.6% 93 +16.2%
Nasacort® 32 0.0% 74 -10.3%
Maalox® 26 +13.0% 54 +8.0%
No Spa® 22 -4.0% 44 -1.9%
Dorflex® 20 -18.5% 43 -10.0%
Magne B6® 21 +22.2% 41 +15.0%
Other CHC Products 460 +2.9% 944 +4.9%
Total Consumer Healthcare 890 +1.3% 1,869 +3.4%

In the second quarter, sales of Consumer Healthcare (CHC) products increased 1.3% to €890 million driven by Allegra®, Lactacyd®, Maalox® and Magne B6®. Sales of CHC in the U.S. were up 7.9% to €237 million over the period sustained by Allegra® and Other CHC Products. Sales of CHC in Emerging Markets were down slightly (2.1% to €432 million) reflecting lower sales in Russia due to softer demand following price increases implemented to partially offset the Ruble depreciation. In Western Europe, sales were broadly stable (down 0.6% to €161 million) despite a price decrease of Doliprane® in France in January 2015. First-half sales of CHC reached €1,869 million, an increase of 3.4%.

Generics

Second-quarter sales of Generics were up 9.2% to €520 million driven by sales in Japan (Rest of the World sales were €27 million, up 225.0%) where Sanofi and its partner Nichi-Iko Pharmaceuticals launched an authorized generic of Plavix® at the end of the quarter. In Emerging Markets, sales of Generics increased 6.0% to €297 million led by Eastern Europe. In the U.S. and Western Europe, second-quarter sales of generics were up 5.3% (to €50 million) and 4.4% (to €146 million), respectively. First-half sales of Generics increased 9.7% to €998 million.

Oncology

€ million Q2 2015
net sales
Change
(CER)
H1 2015
net sales
Change
(CER)
Jevtana® 82 +13.6% 159 +10.6%
Thymoglobulin® 69 +13.0% 124 +2.8%
Taxotere® 62 -16.4% 115 -24.3%
Eloxatin® 57 +6.4% 111 +5.4%
Mozobil® 35 +19.2% 69 +19.6%
Zaltrap® 20 +20.0% 40 +19.4%
Total Oncology 390 +3.6% 747 -1.9%

Sales of Oncology grew 3.6% to €390 million with the performance of Jevtana®, Thymoglobulin®, Mozobil® and Zaltrap® partially offset by the continued impact of generics on Taxotere® in Japan. First-half sales of Oncology were €747 million, down 1.9%.

Second-quarter sales of Jevtana® grew 13.6% to €82 million led by the U.S. (up 18.2% to €33 million) and Japan where the product was launched in September 2014. First-half sales of Jevtana® increased 10.6% to €159 million.

Sales of Thymoglobulin® increased 13.0% to €69 million in the second quarter driven by the U.S. (up 14.8%). First-half sales of Thymoglobulin® increased 2.8% to €124 million.

Second-quarter sales of Taxotere® decreased 16.4% (to €62 million), mainly due to generic competition in Japan. Over the same period, sales of Eloxatin® increased 6.4% (to €57 million) sustained by growth in China. First-half sales of Taxotere® and Eloxatin® were down 24.3% (€115 million) and up 5.4% (€111 million), respectively.

Sales of Mozobil® increased 19.2% to €35 million in the second quarter, driven by growth in the U.S. (up 21.4% to €21 million). First-half sales of Mozobil® increased 19.6% to €69 million.

Second-quarter sales of Zaltrap® grew 20.0% to €20 million, led by sales in Western Europe offseting lower sales in the U.S. First-half sales of Zaltrap® increased 19.4% to €40 million.

Established Rx Products

€ million Q2 2015
net sales
Change
(CER)
H1 2015
net sales
Change
(CER)
Plavix® 545 +15.3% 1,028 +2.1%
Lovenox® 433 -0.5% 871 +0.4%
Renvela®/Renagel® 231 +43.1% 457 +26.5%
Aprovel®/Avapro® 224 +1.0% 425 +0.5%
Synvisc® /Synvisc-One® 116 +4.3% 201 +3.7%
Multaq® 87 +10.6% 170 +2.9%
Myslee®/Ambien®/Stilnox® 74 -6.8% 149 -9.3%
Allegra® 37 -10.3% 117 -6.7%
Other 1,358 -3.0% 2,670 -1.9%
Total Established Rx Products 3,105 +3.1% 6,088 +0.8%

Total sales of Established Rx Products increased 3.1% to €3,105 million and 0.8% to €6,088 million in the second quarter and the first half of 2015, respectively.

Second-quarter sales of Plavix® were up 15.3% to €545 million and benefited from a low second quarter 2014 comparison basis in Japan due to favorable buying patterns in the first quarter of 2014. As expected, multiple generic versions of Plavix® entered the market in Japan at the end of June 2015 and will impact Plavix® sales in the second half of 2015. The performance of Plavix® was driven by Japan (up 39.2% to €208 million) and Emerging Markets (up 9.4% to €278 million), which largely offset the decrease in Western Europe (-16.7% to €45 million). First-half sales of Plavix® increased 2.1% to €1,028 million.

Sales of Lovenox® were €433 million (down 0.5%) in the second quarter. The performance of the product in Emerging Markets (up 5.4% to €163 million) and Western Europe (up 2.7% to €230 million) was offset by lower sales in the U.S. (down 55.2% to €17 million) due to generic competition. Sanofi is aware of competitors that have filed marketing authorisation applications for biosimilar enoxaparin with health authorities in Europe. First-half sales of Lovenox® were €871 million (up 0.4%).

Second-quarter sales of Renvela®/Renagel® were up 43.1% to €231 million driven by the growth in the U.S. (up 59.1% to 174 million) benefited from a low second quarter 2014 comparison due to a  limited allotment of generic Renvela® tablets granted to Impax. Renvela®/Renagel® also recorded strong sales growth in Emerging Markets (up 90.9% to €23 million) in the quarter. Generics are currently marketed in some European countries and we continue to expect potential generic approvals in the U.S. First-half sales of Renvela®/Renagel® were up 26.5% to €457 million.

Sales of Aprovel®/Avapro® were €224 million, up 1.0% in the second quarter. The performance in Emerging Markets (up 19.8% to €143 million) was driven by Latin America and offset lower sales in Western Europe (down 26.9% to €38 million) due to generic competition. First-half sales of Aprovel®/Avapro® were €425 million (up 0.5%).

Vaccines

€ million Q2 2015
net sales
Change
(CER)
H1 2015
net sales
Change
(CER)
Polio/Pertussis/Hib Vaccines
(incl. Pentacel®, Pentaxim® and Imovax®)
273 -14.1% 555 -1.4%
Meningitis/Pneumonia Vaccines
(incl. Menactra®)
145 +7.0% 242 +19.3%
Adult Booster Vaccines (incl. Adacel ®) 118 +21.7% 213 +10.4%
Influenza Vaccines
(incl. Vaxigrip® and Fluzone®)
114 +88.1% 136 -32.0%
Travel and Other Endemic Vaccines 97 -14.6% 179 -9.0%
Other Vaccines 140 +52.7% 259 +47.2%
Total Vaccines
(consolidated sales)
887 +8.6% 1,584 +2.5%

Second-quarter consolidated sales of Sanofi Pasteur increased 8.6% to €887 million driven by influenza vaccines in the Southern Hemisphere, adult booster vaccines and VaxServe (a Sanofi Pasteur company and U.S. specialty supplier of vaccines, sales reported in the line «Other Vaccines »). Second-quarter sales of Sanofi Pasteur grew 7.6% (to €452 million) in the U.S. and 11.3% (to €344 million) in Emerging Markets. First-half sales of Sanofi Pasteur were up 2.5% to €1,584 million.

Sales of Polio/Pertussis/Hib vaccines decreased 14.1% to €273 million in the second quarter reflecting lower sales of Pentacel® in the U.S. due to a high basis for comparison in the second quarter of 2014 and Pentaxim® in China due to phasing effects. Over the period, Shantha sold €7 million of Shan5TM, its pediatric pentavalent vaccine, to supply global health organizations. First-half sales of Polio/Pertussis/Hib vaccines decreased 1.4% to €555 million.

Second-quarter sales of Menactra® were up 5.7% to €133 million driven by sales in Emerging market (up 30.8% to €19 million). First-half sales of Menactra® increased 19.6% to €220 million.

Sales of Adult Booster vaccines increased 21.7% to €118 million in the second quarter led by the U.S. (up 16.9% to €86 million) which benefited from a supply ramp up of Adacel®. First-half sales of Adult Booster vaccines increased 10.4% to €213 million.

Second-quarter sales of Influenza vaccines grew 88.1% to €114 million, benefiting from the delay of the Southern Hemisphere influenza campaign due to the two new strains included in influenza vaccines this year. First-half sales of Influenza vaccines decreased 32.0% to €136 million reflecting lower sales in Brazil due to supply ramp up of the Butantan Institute as a result of the technology transfer agreement with Sanofi Pasteur and sales of pandemic flu vaccines in the U.S. in the first half of 2014.

Second-quarter and first-half sales of Travel and Other Endemic Vaccines declined 14.6% to €97 million and 9.0% to €179 million, respectively.

Sales of Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe, were €161 million (up 3.6% on a reported basis) and €300 million (down 4.2% on a reported basis) in the second quarter and first half, respectively.

Animal Health

€ million Q2 2015
net sales
Change
(CER)
H1 2015
net sales
Change
(CER)
Companion Animal 464 +16.2% 907 +14.7%
Production Animal 227 +10.4% 442 +12.3%
Total Animal Health 691 +14.2% 1,349 +13.9%
  of which Vaccines 205 +5.0% 391 +8.1%
  of which fipronil products 194 +1.8% 387 +1.5%
  of which avermectin products 131 +16.3% 288 +17.0%

Animal Health delivered another quarter of double-digit growth with sales up 14.2% to €691 million in the second quarter continuing the impressive recovery of this business. In the U.S. and Emerging Markets, Animal Health sales grew 20.3% (to €345 million) and 16.3% (to €164 million), respectively. First-half sales of Animal Health increased 13.9% to €1,349 million.

Sales of the Companion Animals segment increased 16.2% to €464 million in the second quarter, reflecting the success of NexGard® and the performance of Heartgard®, which continued to benefit from a limited supply of competitor products. Sales of NexGard®, Merial’s next generation flea and tick product for dogs, more than doubled compared to the second quarter of 2014. Sales of the Frontline® family of products were stable over the period. In July, Merial launched Oravet®, dental hygiene chews for dogs in the U.S. Oravet®, provides a unique, easy-to-administer option, and joins Merial’s extensive product portfolio for pets. First-half sales of Companion Animals segment grew 14.7% to €907 million.

Second-quarter sales of the Production Animals segment were up 10.4% to €227 million driven by the continued recovery of the Avian business in Emerging Markets as well as the Ruminant business, which benefited from the success of LongRange® in the U.S. and IvermecGold® in Brazil. First-half sales of the Production Animals segment grew 12.3% to €442 million.

Net sales by geographic region

€ million Q2 2015
 net sales
Change
(CER)
H1 2015
 net sales
Change
(CER)
United States 3,250 +2.1% 6,226 +1.5%
Emerging Markets(a) 3,182 +7.5% 6,041 +7.4%
  of which Latin America 982 +7.1% 1,828 +7.1%
  of which Asia 934 +9.3% 1,783 +9.0%
  of which Eastern Europe, Russia and Turkey 616 +3.0% 1,202 +5.7%
  of which Africa and Middle East 602 +9.0% 1,132 +6.0%
Western Europe(b) 1,998 +3.4% 4,029 +1.9%
Rest of the world(c) 948 +8.2% 1,892 +2.0%
  of which Japan 545 +9.1% 1,114 -0.5%
TOTAL 9,378 +4.9% 18,188 +3.6%
  1. World less the U.S., Canada, Western Europe, Japan, South Korea, Australia and New Zealand;
  2. France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark;
  3. Japan, South Korea, Canada, Australia and New Zealand;

Second-quarter sales in the U.S. were €3,250 million, up 2.1%. The performance of Genzyme (up 37.0%), Animal Health (up 20.3%), Vaccines (up 7.6%), Oncology (up 8.7%) and CHC (up 7.9%) were partially offset by lower sales of Lantus® (down 15.4%). First-half sales in the U.S. increased 1.5% to €6,226 million.

In Emerging Markets, second-quarter sales grew 7.5% to €3,182 million led by Diabetes (up 17.0%), Genzyme (up 18.0%), vaccines (up 11.3%) and Animal Health (up 16.3%). In Asia, second-quarter sales were up 9.3% led by Pharmaceuticals (up 10.6%). Sales in China grew 9.2% to €537 million driven by Lantus® and Plavix®, which were partially offset by lower Vaccines sales. In Latin America, second-quarter sales grew 7.1% to €982 million driven by Vaccines (up 23.8%) and Animal Health (up 12.9%). Latin American sales benefited from continued higher sales in Venezuela (up 31.1% to €199 million) due to buying patterns associated with local market conditions (Sanofi does not expect this increased demand to be replicated throughout 2015). Sales in Brazil were €334 million (down 5.2%) where sales growth of Diabetes and Vaccines were offset by lower CHC and rare disease sales. Sales in Eastern Europe, Russia and Turkey were up 3.0% to €616 million in the second quarter with the performance in Turkey and Poland was partially offset by lower sales in Russia. Sales in Russia were €159 million, down 11.6% impacted by the local economic and currency situation. In Africa and Middle-East, sales increased 9.0% to €602 million. In the Emerging Markets, first-half sales increased 7.4% to €6,041 million.

In the second quarter, sales in Western Europe increased 3.4% to €1,998 million, which included strong performance of Genzyme (up 24.9%) and 6.5% growth of Diabetes sales. In Western Europe, first-half sales increased 1.9% to €4,029 million.

In Japan, second-quarter sales grew 9.1% to €545 million, reflecting a low basis for comparison for Plavix® and strong contribution from generics, which largely offset lower sales of Vaccines and generic Taxotere® competition. In Japan, first-half sales decreased 0.5% to €1,114 million.

R&D update

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

Regulatory update

Regulatory updates since the publication of the first quarter results on April 30, 2015 include the following:

  • In late July, a New Drug Application (NDA) for lixisenatide, a once-daily GLP-1 analogue, was submitted to the U.S. Food and Drug Administration (FDA) for the treatment of Diabetes.
  • In July, the U.S. FDA approved Praluent® (alirocumab, collaboration with Regeneron), the first FDA-approved treatment in a new class of drugs known as PCSK9 inhibitors. Praluent® is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein (LDL) cholesterol. In parallel, the CHMP also issued an opinion recommending the approval of Praluent® in EU in July. The final EMA decision is expected in late September.
  • In July, the Ministry of Health, Labor and Welfare (MHLW) in Japan granted a marketing authorization for Lantus® XR (known as Toujeo® in the U.S. and Europe), a next-generation basal insulin for the treatment of type 1 and type 2 diabetes. Toujeo® was also approved in Canada in May and Australia in June.
  • In June, the FDA granted Breakthrough Therapy designation to olipudase alfa. This enzyme replacement therapy is being investigated by Genzyme for the treatment of patients with Niemann-Pick disease Type B.

At the end of July 2015, the R&D pipeline contained 36 pharmaceutical new molecular entities (excluding Life Cycle Management) and vaccine candidates in clinical development of which 12 are in Phase III or have been submitted to the regulatory authorities for approval.

Collaboration

At the end of July, Sanofi and Regeneron entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the emerging field of immuno-oncology. As part of the agreement, the two companies will jointly develop a programmed cell death protein 1 (PD-1) inhibitor currently in Phase 1 testing, and plan to initiate clinical trials in 2016 with new therapeutic candidates based on ongoing, innovative preclinical programs. Beyond PD-1, other targets in preclinical development include antibodies to lymphocyte-activation gene 3 (LAG3), glucocorticoid-induced tumornecrosis-factor-receptor-related protein (GITR) and a programmed death-ligand 1 (PD-L1) inhibitor.

Portfolio update

Phase III:

  • In June, Sanofi and Regeneron announced that the Phase III ODYSSEY JAPAN trial of Praluent® (alirocumab) met its primary endpoint. At week 24, patients in the Praluent group experienced an average 64 percent greater reduction from baseline in their LDL-C, when added to current standard of care including statins, compared to standard of care alone (p<0.0001).
  • The full results of the Phase IIIb ELIXA study, which was designed to assess the cardiovascular (CV) safety of Lyxumia® (lixisenatide) in adults with type 2 diabetes and high CV risk were presented in June and support the recent U.S. NDA for lixisenatide submitted to the FDA.
  • In June the results from the EDITION JP 1 and EDITION JP 2 extension studies where Japanese participants (with type 1 and type 2 diabetes, respectively) received Toujeo® or Lantus® for a total of 12 months, were presented and showed that Toujeo® maintained similar blood sugar control, with fewer people experiencing night-time low blood sugar events, compared with Lantus®.
  • In May, Sanofi and Regeneron announced that, SARIL-RA-TARGET, a Phase III study of sarilumab, an investigational, fully-human IL6 receptor antibody, met its co-primary efficacy endpoints in patients with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of TNF-alpha inhibitors (TNF-IR). Two additional trials from the Phase III program, SARIL-RA-EASY and SARIL-RA-ASCERTAIN evaluating the usability of the sarilumab autoinjector device and a safety calibrator study designed to assess the safety of two subcutaneous doses of sarilumab and tocilizumab infusion, respectively, also met their primary endpoints. Detailed results from all three SARIL-RA trials will be presented at future medical congresses

Phase II:

  • Additional positive results from an interim analysis of a pivotal Phase IIb study of dupilumab (in collaboration with Regeneron) in adult patients with moderate-to-severe asthma who are uncontrolled despite treatment with inhaled corticosteroids and long-acting beta agonists, were presented in May. The study met its primary endpoint of improving lung function in asthma patients with high blood eosinophils counts. Based on discussions with the U.S. FDA, this Phase IIb study may be considered one of two pivotal efficacy studies required for a potential dupilumab biologics license application (BLA) in asthma. A Phase III clinical trial of dupilumab in patients with uncontrolled persistent asthma has been initiated.
  • Olipudase alfa, GZ402665, an investigational enzyme replacement therapy for Niemann-Pick type B, moved into Phase II.
  • Sanofi decided to opt out the anti-GDF8 monoclonal antibody (SAR391786, collaboration with Regeneron) evaluated in Sarcopenia.
  • The Proof of Concept study of fresolimumab in focal segmental glomerulosclerosis was not achieved.

Phase I:

  • A TrkA antagonist GR389988, entered Phase I in osteo-arthritis.

2015 second-quarter and first-half financial results

Business Net Income(5)

In the second quarter of 2015, Sanofi generated net sales of €9,378 million, an increase of 16.1% on a reported basis (up 4.9% at constant exchange rates). First-half sales were €18,188 million, an increase of 14.3% on a reported basis (up 3.6% at constant exchange rates).

Other revenues were €83 million, up 16.9% and €163 million, up 5.8% in the second quarter and the first half, respectively. At constant exchange rates, other revenues were stable in the second quarter and down 7.8% in the first half, reflecting lower royalties received on Enbrel® sales in Europe.

Second-quarter gross profit increased 17.8% (up 4.8% at constant exchange rates) to €6,523 million. The gross margin ratio improved by 1.0 percentage points to 69.6% versus the second quarter of 2014. This improvement was driven essentially by the favorable currency effect. The positive impact from Genzyme and Renagel® was offset by Vaccines mix and Lantus® U.S. In the first half of 2015, the gross margin ratio improved by 0.6 percentage points to 69.4% versus the first half of 2014. Sanofi continues to expect that the gross margin for 2015 will be between 68% and 69%.

Second-quarter Research and development expenses were up 8.6% (down 0.3% at constant exchange rates) to €1,290 million reflecting lower spend in Diabetes, alirocumab and Oncology but higher spend on dupilumab. First-half R&D expenses increased 7.0% (down 1.0% at constant exchange rates) to €2,489 million. In the first half of 2015, the ratio of R&D to net sales was 0.9 percentage points lower at 13.7%.

Selling and general expenses (SG&A) increased 17.4% to €2,648 million in the second quarter. At constant exchange rates, SG&A grew 5.9% driven by launches in Multiple Sclerosis, Animal Health and Diabetes. The ratio of SG&A to net sales was 0.3 percentage points higher to 28.2% compared with the second quarter of 2014. First-half SG&A expenses were €5,086 million, an increase of 17.4% (up 6.2% at constant exchange rates). In the first half of 2015, the ratio of selling and general expenses to net sales was 0.8 percentage points higher to 28.0% compared with the first half of 2014.

Other current operating income net of expenses was -€20 million in the second quarter versus €54 million in the second quarter of 2014 which included a payment of €62 million related to the return of Eligard® U.S. rights to Tolmar Pharmaceuticals. First-half other current operating income net of expenses was -€87 million compared to €29 million for the same period of 2014. In the first half of 2015, this line included a foreign exchange loss of €100 million in connection with our Venezuelan operations.

The share of profits from associates was €30 million in the second quarter versus €26 million in the second quarter of 2014 and included Sanofi’s share in Regeneron profit recorded under the equity method since the beginning of April 2014 as well as Sanofi’s share of profit in Sanofi Pasteur MSD (the Vaccines joint venture with Merck & Co. in Europe). In the first half, the share of profits from associates was €61 million versus €39 million for the same period of 2014.

Non-controlling interests were -€29 million in the second quarter (versus -€30 million in the second quarter of 2014). First-half non-controlling interests were -€62 million versus -€65 million for the same period of 2014.

Business operating income(6) increased 19.6% to €2,566 million in the second quarter. At constant exchange rates, business operating income grew 4.7%. The ratio of business operating income to net sales was 0.8 percentage points higher to 27.4% versus the same period of last year. First-half business operating income was €4,964 million, up 15.7% (or up 3.4% at constant exchange rates). In the first half of 2015, the ratio of business operating income to net sales improved by 0.3 percentage points to 27.3%.

 (5) See Appendix 10 for definitions of financial indicators, and Appendix 3 for reconciliation of business net income to IFRS net income reported
(6) Business operating income is the segment result used by the Group. The consolidated income statement for Q2 2015 is provided in Appendix 4

Net financial expenses were €112 million in the second quarter compared to €94 million in the second quarter of 2014. In the second quarter 2014, this line included a capital gain of €31 million before tax linked to the sales of some financial investments. First-half net financial expenses were €209 million versus €170 million in the first half of 2014.

Second-quarter and first-half effective tax rates were 25%, which were stable versus the same periods of 2014.

Second-quarter business net income(5) was up 19.7% to €1,840 million. At constant exchange rates, business net income increased 4.2%. The ratio of business net income to net sales was 19.6% in the second quarter versus 19.0% in the second quarter of 2014. First-half business net income increased 15.6% to €3,566 million, (up 2.9% at constant exchange rates). The ratio of business net income to net sales improved by 0.2 percentage points to 19.6% compared to the first half of 2014.

In the second quarter of 2015, business earnings per share(5) (EPS) was €1.41, up 20.5% on a reported basis and up 5.1% at constant exchange rates. The average number of shares outstanding was 1,305.9 million in the second quarter versus 1,314.5 million in the same period in 2014. In the first half of 2015, business earnings per share(1) was €2.73, up 16.7% on a reported basis and up 3.8% at constant exchange rates. The average number of shares outstanding was 1,307.2 million in the first half versus 1,317.2 million in the first half of 2014.

From business net income to IFRS net income reported (see Appendix 3)

In the first half of 2015, the main reconciling items between business net income and IFRS net income reported were:

  • A €1,229 million amortization charge related to fair value remeasurement on intangible assets of acquired companies (primarily Aventis: €354 million, Genzyme: €449 million and Merial: €241 million) and to acquired intangible assets (licenses/products: €57 million). A €611 million amortization charge on intangible assets related to fair value remeasurement of acquired companies (primarily Aventis: €176 million, Genzyme: €223 million and Merial: €122 million), and to acquired intangible assets (licenses/products: €29 million) was booked in the second quarter. These items have no cash impact on the Group.
  • An impairment of intangible assets of €28 million (of which €1 million in the second quarter of 2015). This item has no cash impact on the Group.
  • An income of €71 million mainly reflecting a decrease in the fair value of contingent considerations related to the CVRs (€18 million, of which a charge of €5 million in the second quarter of 2015) and a decrease of Bayer contingent considerations (€39 million, of which €59 million in the second quarter of 2015) linked to Lemtrada®.
  • Restructuring costs of €381 million (including €28 million in the second quarter mainly related to continuation of transformation in Europe).
  • A €561 million tax effect arising from the items listed above, comprising €431 million of deferred taxes generated by amortization charged against intangible assets, €135 million associated with restructuring costs, €10 million associated with impairment of intangible assets and a charge of €15 million associated with fair value remeasurement of contingent consideration liabilities The second quarter tax effect was €206 million, including €214 million of deferred taxes generated by amortization charged against intangible assets and a charge of €22 million associated with fair value remeasurement of contingent consideration liabilities (see Appendix 3).
  • A tax of €111 million on dividends paid to shareholders of Sanofi.

(5) See Appendix 10 for definitions of financial indicators, and Appendix 3 for reconciliation of business net income to IFRS net income reported

  • In “Share of profits/losses from associates”, a charge of €127 million, net of tax, (of which €65 million in the second quarter of 2015) mainly relating to the share of the fair-value re-measurements on assets and liabilities as part of the acquisition of associates and to the share of amortization of intangible assets of joint-ventures. This item has no cash impact on the Group.

Capital Allocation

In the first half of 2015, net cash generated by operating activities increased 29% to €3,084 million after capital expenditures of €667 million and an increase in working capital by €181 million. This net Cash Flow has contributed to finance a share repurchase (€1,243 million), partially offset by proceeds from the issuance of new shares (€462 million), dividend paid by Sanofi (€3,694 million), acquisitions and partnerships net of disposals (€363 million) and restructuring costs (€345 million). As a consequence, net debt increased from €7,171 million at December 31, 2014 to €9,726 million at the end of June 2015 (amount net of €4,701 million cash and cash equivalents) and included the translation impact of the debt, which represented €391 million, mainly related to the debt held in U.S. dollars.

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, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies 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, 2014. 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: 2015 second-quarter and 2015 first-half consolidated net sales by geographic region and product
Appendix 2: 2015 second-quarter and 2015 first-half business net income statement
Appendix 3: Reconciliation of business net income to IFRS net income reported
Appendix 4: 2015 second-quarter and 2015 first-half consolidated income statement
Appendix 5: Change in net debt
Appendix 6: Simplified consolidated balance sheet
Appendix 7: 2015 currency sensitivity
Appendix 8: R&D pipeline
Appendix 9: Expected R&D milestones
Appendix 10: Definitions

Appendix 1: Net sales by geographic region and product

Q2 2015 net sales
(€ million)
Total % CER %
reported
Western
Europe
% CER United
States
% CER Emer-ging
Markets
% CER Rest of the World % CER
Lantus 1,709 -5.8% 9.8% 230 6.1% 1,086 -15.4% 305 21.4% 88 6.7%
Apidra 93 11.7% 20.8% 26 8.3% 34 0.0% 24 27.8% 9 25.0%
Amaryl 109 0.0% 13.5% 4 0.0% 0 -100.0% 90 1.3% 15 0.0%
Insuman 34 0.0% 3.0% 20 5.3% 1 0.0% 14 8.3% -1 -200.0%
BGM 16 0.0% 0.0% 15 0.0% 0 0 1 0.0%
Lyxumia 10 50.0% 66.7% 5 25.0% 0 1 0.0% 4 200.0%
Afrezza 2 0 2 0 0
Toujeo 13 1 11 0 1
Other Diabetes 2 -33.3% -33.3% 0 0 1 1 -66.7%
Diabetes 1,988 -3.8% 11.2% 301 6.5% 1,134 -14.0% 435 17.0% 118 4.8%
Taxotere 62 -16.4% -7.5% 2 -75.0% 1 -50.0% 38 6.1% 21 -32.1%
Jevtana 82 13.6% 24.2% 35 2.9% 33 18.2% 8 -10.0% 6
Eloxatine 57 6.4% 21.3% 1 0.0% 1 33 16.0% 22 -4.8%
Thymoglobulin 69 13.0% 27.8% 9 25.0% 38 14.8% 18 6.7% 4 0.0%
Mozobil 35 19.2% 34.6% 9 12.5% 21 21.4% 3 50.0% 2 0.0%
Zaltrap 20 20.0% 33.3% 12 22.2% 6 -16.7% 2 100.0% 0 -100.0%
Other Oncology 65 -6.6% 6.6% 13 0.0% 41 0.0% 5 -25.0% 6 -28.6%
Oncology 390 3.6% 16.1% 81 3.9% 141 8.7% 107 6.4% 61 -9.8%
Aubagio 204 80.4% 110.3% 46 123.8% 142 59.7% 7 250.0% 9 200.0%
Lemtrada 56 733.3% 833.3% 21 300.0% 29 2 4 200.0%
Cerezyme 199 6.3% 13.7% 62 1.7% 49 -11.1% 76 28.1% 12 -7.7%
Cerdelga 16 1 15 0 0
Myozyme 165 14.3% 24.1% 73 6.0% 51 21.2% 31 20.0% 10 37.5%
Fabrazyme 146 4.9% 18.7% 33 14.3% 76 9.1% 18 -29.2% 19 25.0%
Aldurazyme 50 4.4% 11.1% 18 6.3% 11 -11.1% 17 6.3% 4 25.0%
Other Rare Diseases products 71 -1.6% 10.9% 11 0.0% 25 9.5% 11 11.1% 24 -18.2%
Genzyme 907 26.6% 41.1% 265 24.9% 398 37.0% 162 18.0% 82 12.1%
Plavix 545 15.3% 28.2% 45 -16.7% 0 -100.0% 278 9.4% 222 35.0%
Lovenox 433 -0.5% 2.9% 230 2.7% 17 -55.2% 163 5.4% 23 0.0%
Renagel / Renvela 231 43.1% 68.6% 29 -15.2% 174 59.1% 23 90.9% 5 40.0%
Aprovel 224 1.0% 16.1% 38 -26.9% 5 -40.0% 143 19.8% 38 -5.7%
Allegra 37 -10.3% -5.1% 3 0.0% 0 1 -50.0% 33 -8.8%
Myslee / Ambien / Stilnox 74 -6.8% 1.4% 9 -10.0% 17 -22.2% 17 7.1% 31 -3.2%
Synvisc / Synvisc One 116 4.3% 24.7% 8 0.0% 90 -2.7% 14 44.4% 4 100.0%
Multaq 87 10.6% 31.8% 10 -16.7% 74 15.4% 2 0.0% 1
Depakine 108 2.0% 9.1% 35 0.0% 0 70 6.6% 3 -50.0%
Tritace 70 -10.7% -6.7% 30 -9.1% 0 38 -10.0% 2 -50.0%
Lasix 47 0.0% 4.4% 20 -5.0% 1 16 7.7% 10 0.0%
Targocid 42 2.6% 10.5% 20 -4.8% 0 19 13.3% 3 0.0%
Orudis 43 -16.7% -10.4% 5 0.0% 0 37 -19.0% 1 0.0%
Cordarone 33 -3.0% 0.0% 6 0.0% 0 19 0.0% 8 -11.1%
Xatral 23 -8.7% 0.0% 9 0.0% 0 12 -15.4% 2 0.0%
Actonel 6 -75.0% -70.0% 0 -100.0% 0 4 -62.5% 2 -71.4%
Auvi-Q / Allerject 35 81.3% 118.8% 0 32 92.3% 0 3 33.3%
Other Rx Drugs 951 -2.4% 2.6% 391 5.2% 83 -29.3% 385 1.9% 92 -18.8%
Total Other Rx Drugs 3,105 3.1% 12.1% 888 -1.8% 493 4.7% 1,241 5.3% 483 6.3%
Consumer Healthcare 890 1.3% 9.1% 161 -0.6% 237 7.9% 432 -2.1% 60 14.6%
Generics 520 9.2% 11.6% 146 4.4% 50 5.3% 297 6.0% 27 225.0%
Pharmaceuticals 7,800 3.7% 14.4% 1,842 3.5% 2,453 -1.0% 2,674 6.5% 831 8.2%
Polio / Pertussis / Hib 273 -14.1% -3.9% 10 66.7% 89 -20.0% 147 -8.8% 27 -32.5%
Adult Booster Vaccines 118 21.7% 42.2% 8 0.0% 86 16.9% 19 63.6% 5 20.0%
Meningitis / Pneumonia 145 7.0% 26.1% 0 113 -1.1% 30 31.8% 2
Influenza Vaccines 114 88.1% 93.2% 1 0.0% 0 102 81.8% 11 233.3%
Travel And Other Andemics Vaccines 97 -14.6% -5.8% 6 -25.0% 31 -16.1% 44 -19.2% 16 16.7%
Other Vaccines 140 52.7% 89.2% -1 0.0% 133 59.7% 2 -60.0% 6 66.7%
Vaccines 887 8.6% 23.5% 24 9.1% 452 7.6% 344 11.3% 67 1.6%
Fipronil products 194 1.8% 14.8% 52 2.0% 104 -4.5% 33 34.8% 5 -28.6%
Vaccines 205 5.0% 13.9% 45 -2.2% 51 7.9% 94 4.8% 15 25.0%
Avermectin products 131 16.3% 33.7% 10 -16.7% 83 17.5% 18 41.7% 20 17.6%
Others 161 53.3% 78.9% 25 9.1% 107 79.2% 19 31.3% 10 75.0%
Animal Health 691 14.2% 28.7% 132 0.0% 345 20.3% 164 16.3% 50 17.5%
Total Group 9,378 4.9% 16.1% 1,998 3.4% 3,250 2.1% 3,182 7.5% 948 8.2%

 

H1 2015 net sales
(€ million)
Total % CER %
reported
Western
Europe
% CER United
States
% CER Emer-ging
Markets
% CER Rest of the World % CER
Lantus 3,293 -5.4% 9.6% 453 6.2% 2,093 -14.3% 581 19.7% 166 4.1%
Apidra 184 11.2% 21.1% 51 8.5% 69 1.8% 46 29.4% 18 12.5%
Amaryl 206 0.5% 13.2% 8 -20.0% 1 0.0% 168 6.5% 29 -18.2%
Insuman 67 1.5% 3.1% 38 -5.0% 1 0.0% 28 16.7% 0
BGM 32 0.0% 0.0% 30 3.4% 0 1 0.0% 1 -50.0%
Lyxumia 18 54.5% 63.6% 10 42.9% 0 3 200.0% 5 33.3%
Afrezza 3 0 3 0 0
Toujeo 20 1 18 0 1
Other Diabetes 2 -33.3% -33.3% 0 0 1 1 -66.7%
Diabetes 3,825 -3.5% 10.9% 591 5.6% 2,185 -13.0% 828 17.7% 221 -0.5%
Taxotere 115 -24.3% -15.4% 4 -62.5% 3 -40.0% 69 -11.6% 39 -33.3%
Jevtana 159 10.6% 20.5% 73 0.0% 60 16.7% 16 -5.9% 10 800.0%
Eloxatine 111 5.4% 19.4% 2 0.0% 2 0.0% 65 12.0% 42 -2.5%
Thymoglobulin 124 2.8% 17.0% 18 12.5% 70 14.0% 27 -18.8% 9 0.0%
Mozobil 69 19.6% 35.3% 19 12.5% 39 18.5% 8 60.0% 3 0.0%
Zaltrap 40 19.4% 29.0% 25 50.0% 12 -28.6% 3 50.0% 0 -100.0%
Other Oncology 129 -13.7% -1.5% 27 -6.9% 79 -17.9% 13 -20.0% 10 11.1%
Oncology 747 -1.9% 9.9% 168 3.1% 265 -0.5% 201 -4.2% 113 -7.9%
Aubagio 374 84.0% 113.7% 82 115.8% 265 64.1% 13 300.0% 14 333.3%
Lemtrada 94 663.6% 754.5% 39 280.0% 45 4 6 400.0%
Cerezyme 388 5.5% 13.1% 123 2.5% 99 -10.0% 142 22.3% 24 0.0%
Cerdelga 26 1 25 0 0
Myozyme 321 16.5% 26.4% 142 6.9% 99 25.0% 59 27.3% 21 31.3%
Fabrazyme 287 14.9% 29.9% 64 18.9% 147 12.3% 37 12.9% 39 19.4%
Aldurazyme 98 7.0% 14.0% 35 6.3% 20 0.0% 33 10.3% 10 11.1%
Other Rare Diseases products 140 4.2% 17.6% 23 9.5% 55 15.0% 19 18.8% 43 -14.3%
Genzyme 1,728 28.6% 42.9% 509 24.6% 755 37.4% 307 25.5% 157 16.1%
Plavix 1,028 2.1% 12.7% 89 -24.1% 0 -100.0% 504 5.1% 435 7.0%
Lovenox 871 0.4% 4.1% 461 1.3% 43 -42.6% 320 8.2% 47 0.0%
Renagel / Renvela 457 26.5% 47.9% 62 -6.2% 339 36.6% 45 31.3% 11 20.0%
Aprovel 425 0.5% 14.2% 75 -30.2% 8 -33.3% 268 19.3% 74 0.0%
Allegra 117 -6.7% -1.7% 6 0.0% 0 1 -50.0% 110 -6.3%
Myslee / Ambien / Stilnox 149 -9.3% -1.3% 19 -9.5% 35 -14.7% 33 7.1% 62 -13.2%
Synvisc / Synvisc One 201 3.7% 23.3% 15 7.1% 155 -0.8% 24 29.4% 7 20.0%
Multaq 170 2.9% 22.3% 20 -9.1% 144 4.5% 5 0.0% 1 100.0%
Depakine 212 4.7% 11.0% 70 1.5% 0 135 8.6% 7 -25.0%
Tritace 145 -2.8% 1.4% 60 -7.7% 0 82 4.1% 3 -40.0%
Lasix 89 4.9% 9.9% 38 -7.5% 2 0.0% 30 8.0% 19 33.3%
Targocid 82 2.7% 9.3% 40 -2.4% 0 38 13.3% 4 -25.0%
Orudis 93 3.6% 12.0% 9 -10.0% 0 82 5.6% 2 0.0%
Cordarone 67 0.0% 3.1% 12 0.0% 0 39 5.6% 16 -11.8%
Xatral 48 -6.4% 2.1% 18 -5.3% 0 27 -7.7% 3 0.0%
Actonel 13 -70.7% -68.3% 1 -88.9% 0 8 -55.6% 4 -78.6%
Auvi-Q / Allerject 52 65.4% 100.0% 1 0.0% 45 71.4% 0 6 50.0%
Other Rx Drugs 1,869 -2.7% 1.8% 785 0.4% 164 -31.5% 736 5.1% 184 -12.4%
Total Other Rx Drugs 6,088 0.8% 8.9% 1,781 -4.1% 935 -0.5% 2,377 7.1% 995 -2.1%
Consumer Healthcare 1,869 3.4% 9.9% 363 0.0% 496 6.6% 887 2.1% 123 15.0%
Generics 998 9.7% 12.5% 284 0.7% 91 10.6% 574 9.1% 49 161.1%
Pharmaceuticals 15,255 3.0% 12.9% 3,696 1.7% 4,727 -1.8% 5,174 8.4% 1,658 2.2%
Polio / Pertussis / Hib 555 -1.4% 12.1% 17 41.7% 207 1.2% 279 6.7% 52 -38.0%
Adult Booster Vaccines 213 10.4% 29.9% 13 -18.8% 159 4.9% 31 61.1% 10 42.9%
Meningitis / Pneumonia 242 19.3% 41.5% 1 187 16.0% 50 29.7% 4 0.0%
Influenza Vaccines 136 -32.0% -29.9% 1 0.0% -2 -104.8% 122 -25.6% 15 8.3%
Travel And Other Andemics Vaccines 179 -9.0% 0.6% 14 7.7% 50 -10.9% 84 -14.1% 31 3.7%
Other Vaccines 259 47.2% 79.9% -1 -200.0% 246 50.8% 6 -16.7% 8 80.0%
Vaccines 1,584 2.5% 17.7% 45 4.7% 847 11.1% 572 -3.1% 120 -15.8%
Fipronil products 387 1.5% 13.8% 121 6.3% 192 -4.9% 57 20.0% 17 -15.8%
Vaccines 391 8.1% 17.1% 87 -1.1% 94 5.6% 173 7.2% 37 59.1%
Avermectin products 288 17.0% 35.8% 27 -3.6% 191 25.0% 29 17.4% 41 5.4%
Others 283 46.4% 68.5% 53 15.9% 175 59.6% 36 29.6% 19 125.0%
Animal Health 1,349 13.9% 28.0% 288 4.4% 652 17.8% 295 13.0% 114 25.6%
Total Group 18,188 3.6% 14.3% 4,029 1.9% 6,226 1.5% 6,041 7.4% 1,892 2.0%

Appendix 2: Business net income statement

Second quarter 2015 Group Total Pharmaceuticals Vaccines Animal Health Others
€ million Q2
2015
Q2
2014
Change Q2
2015
Q2
2014
Change Q2
2015
Q2
2014
Change Q2
2015
Q2
2014
Change Q2
2015
Q2
2014
Net sales 9,378 8,075 16.1% 7,800 6,820 14.4% 887 718 23.5% 691 537 28.7%
Other revenues 83 71 16.9% 67 58 15.5% 8 7 14.3% 8 6 33.3%
Cost of sales (2,938) (2,608) 12.7% (2,252) (2,058) 9.4% (450) (350) 28.6% (236) (200) 18.0%
As % of net sales (31.3%) (32.3%)   (28.9%) (30.2%)   (50.7%) (48.8%)   (34.2%) (37.2%)      
Gross profit 6,523 5,538 17.8% 5,615 4,820 16.5% 445 375 18.7% 463 343 35.0%
As % of net sales 69.6% 68.6%   72.0% 70.7%   50.2% 52.2%   67.0% 63.9%      
Research & Development expenses (1,290) (1,188) 8.6% (1,104) (1,030) 7.2% (142) (123) 15.4% (44) (35) 25.7%
As % of net sales (13.8%) (14.7%)   (14.2%) (15.1%)   (16.0%) (17.1%)   (6.4%) (6.5%)      
Selling and general expenses (2,648) (2,255) 17.4% (2,216) (1,930) 14.8% (188) (142) 32.4% (244) (183) 33.3%
As % of net sales (28.2%) (27.9%)   (28.4%) (28.3%)   (21.2%) (19.8%)   (35.3%) (34.1%)      
Other current operating income / expenses (20) 54   (11) 42   1 3   5 11   (15) (2)
Share of profit / loss of associates (1) and joint ventures 30 26   29 25   1 1    
Net income attributable to non-controlling interests (29) (30)   (29) (30)      
Business operating income 2,566 2,145 19.6% 2,284 1,897 20.4% 117 114 2.6% 180 136 32.4% (15) (2)
As % of net sales 27.4% 26.6%   29.3% 27.8%   13.2% 15.9%   26.0% 25.3%      
Financial income and expenses (112) (94)                        
Income tax expense (614) (514)                        
Tax rate (2) 25.0% 25.0%                        
Business net income 1,840 1,537 19.7%                      
As % of net sales 19.6% 19.0%                        
Business earnings per share (3)
(in euros)
1.41 1.17 20.5%                      
  1. Net of tax
  2. Determined on the basis of Business income before tax, associates and non-controlling interests
  3. Based on an average number of shares outstanding of 1,305.9 million in the second quarter of 2015 and 1,314.5 million in the second quarter of 2014
First Half 2015 Group Total Pharmaceuticals Vaccines Animal Health Others
€ million H1
2015
H1
2014
Change H1
2015
H1
2014
Change H1
2015
H1
2014
Change H1
2015
H1
2014
Change H1
2015
H1
2014
Net sales 18,188 15,917 14.3% 15,255 13,517 12.9% 1,584 1,346 17.7% 1,349 1,054 28.0%
Other revenues 163 154 5.8% 129 126 2.4% 14 14 20 14 42.9%
Cost of sales (5,724) (5,124) 11.7% (4,442) (4,046) 9.8% (826) (700) 18.0% (456) (378) 20.6%
As % of net sales (31.5%) (32.2%)   (29.1%) (29.9%)   (52.1%) (52.0%)   (33.8%) (35.8%)      
Gross profit 12,627 10,947 15.3% 10,942 9,597 14.0% 772 660 17.0% 913 690 32.3%
As % of net sales 69.4% 68.8%   71.7% 71.0%   48.7% 49.0%   67.7% 65.5%      
Research & Development expenses (2,489) (2,327) 7.0% (2,143) (2,025) 5.8% (262) (230) 13.9% (84) (72) 16.7%
As % of net sales (13.7%) (14.6%)   (14.0%) (15.0%)   (16.5%) (17.1%)   (6.2%) (6.8%)      
Selling and general expenses (5,086) (4,333) 17.4% (4,310) (3,721) 15.8% (344) (271) 26.9% (432) (341) 26.7%
As % of net sales (28.0%) (27.2%)   (28.3%) (27.5%)   (21.7%) (20.1%)   (32.0%) (32.4%)      
Other current operating income / expenses (87) 29   (39) 19   2 1   5 17   (55) (8)
Share of profit/loss of associates (1) and joint ventures 61 39   61 33   6    
Net income attributable to non-controlling interests (62) (65)   (62) (65)      
Business operating income 4,964 4,290 15.7% 4,449 3,838 15.9% 168 166 1.2% 402 294 36.7% (55) (8)
As % of net sales 27.3% 27.0%   29.2% 28.4%   10.6% 12.3%   29.8% 27.9%      
Financial income and expenses (209) (170)                        
Income tax expense (1,189) (1,036)                        
Tax rate (2) 25.0% 25.0%                        
Business net income 3,566 3,084 15.6%                      
As % of net sales 19.6% 19.4%                        
Business earnings per share (3)
(in euros)
2.73 2.34 16.7%                      
  1. Net of tax
  2. Determined on the basis of Business income before tax, associates and non-controlling interests
  3. Based on an average number of shares outstanding of 1,307.2 million in the first semester of 2015 and 1,317.2 million in the first semester of 2014

Appendix 3: Reconciliation of Business net income to IFRS net income reported

€ million Q2 2015 Q2 2014 Change
Business net income 1,840 1,537 19.7%
Amortization of intangible assets(1) (611) (624)  
Impairment of intangible assets (1) (71)  
Fair value remeasurement of contingent
consideration liabilities
70 (124)  
Restructuring costs (28) (84)  
Other gains and losses, and litigation  
Tax effect of items listed above: 206 274
Amortization of intangible assets 214 207  
Impairment of intangible assets 25  
Fair value remeasurement of contingent consideration liabilities (22) 13  
Other gains and losses, and litigation  
Restructuring costs 14 29  
Other tax items(2) (111) (110)  
Share of items listed above attributable to non-controlling interests 2 3
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures (65) (24)
IFRS net income reported (3) 1,302 777 67.6%
IFRS earnings per share(4) reported (in euros) 1.00 0.59  
  1. Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €582 million in the second quarter of 2015 and €601 million in the second quarter of 2014
  2. Tax on dividends paid to shareholders of Sanofi
  3. Net income attributable to equity holders of Sanofi
  4. Based on an average number of shares outstanding of 1,305.9 million in the second quarter of 2015 and 1,314.5 in the second quarter of 2014

See page 12 for comments on the reconciliation of business net income to consolidated net income.

€ million H1 2015 H1 2014 Change
Business net income 3,566 3, 084 15.6%
Amortization of intangible assets(1) (1,229) (1,301)  
Impairment of intangible assets (28) (74)  
Fair value remeasurement of contingent
consideration liabilities
71 (132)  
Restructuring costs (381) (135)  
Other gains and losses, and litigation 35  
Tax effect of items listed above: 561 522
Amortization of intangible assets 431 451  
Impairment of intangible assets 10 26  
Fair value remeasurement of contingent consideration liabilities (15) 14  
other gains and losses, and litigation (13)  
Restructuring costs 135 44  
Other tax items(2) (111) (110)  
Share of items listed above attributable to non-controlling interests 3 4
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures (127) (32)
IFRS net income reported(3) 2,325 1,861 24.9%
IFRS earnings per share(4) reported (in euros) 1.78 1.41  
  1. Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €1,172 million in the first semester of 2015 and €1,258 million in the first semester of 2014
  2. Tax on dividends paid to shareholders of Sanofi
  3. Net income attributable to equity holders of Sanofi
  4. Based on an average number of shares outstanding of 1,307.2 million in the first semester of 2015 and 1,317.2 in the first semester of 2014

See page 12 for comments on the reconciliation of business net income to IFRS net income reported.

Appendix 4: Consolidated income statement

€ million Q2 2015 Q2 2014 H1 2015 H1 2014
Net sales 9,378 8,075 18,188 15,917
Other revenues 83 71 163 154
Cost of sales (2,938) (2,608) (5,724) (5,124)
Gross profit 6,523 5,538 12,627 10,947
Research and development expenses (1,290) (1,188) (2,489) (2,327)
Selling and general expenses (2,648) (2,255) (5,086) (4,333)
Other operating income 47 106 83 116
Other operating expenses (67) (52) (170) (87)
Amortization of intangible assets (611) (624) (1,229) (1,301)
Impairment of intangible assets (1) (71) (28) (74)
Fair value remeasurement of contingent consideration liabilities 70 (124) 71 (132)
Restructuring costs (28) (84) (381) (135)
Operating income 1,995 1,246 3,398 2,674
Financial expense (134) (145) (267) (292)
Financial income 22 51 58 157
Income before tax and associates and joint ventures 1,883 1,152 3,189 2,539
Income tax expense(1) (519) (350) (739) (624)
Share of profit/loss of associates and joint ventures (35) 2 (66) 7
Net income 1,329 804 2,384 1,922
Net income attributable to non-controlling interests 27 27 59 61
Net income attributable to equity holders of Sanofi 1,302 777 2,325 1,861
Average number of shares outstanding (million) 1,305.9 1,314.5 1,307.2 1,317.2
Earnings per share (in euros) 1.00 0.59 1.78 1.41
  1. In 2015, including a tax on dividends paid to shareholders of Sanofi: (111) M€ compared to (110) M€ in 2014

Appendix 5: Change in net debt

€ million H1 2015 H1 2014
Business net income 3,566 3,084
Depreciation amortization and impairment of property. plant and equipment and software 628 582
Net gains and losses on disposals of non-current assets, net of tax (44) (97)
Other non-cash items (218) (98)
Operating cash flow before changes in working capital (1) 3,932 3,471
Changes in working capital (1) (181) (552)
Acquisitions of property, plant and equipment and software (667) (529)
Free cash flow (1) 3,084 2,390
Acquisitions of intangibles, excluding software (280) (108)
Acquisitions of investments, including assumed debt (169) (1,679)
Restructuring costs paid (345) (382)
Proceeds from disposals of property, plant and equipment, intangibles, and other non-current assets, net of tax(1) 86 179
Issuance of Sanofi shares 462 240
Dividends paid to shareholders  of Sanofi (3,694) (3,676)
Acquisition of treasury shares (1,243) (1,010)
Transactions with non-controlling interests including dividends (16) (6)
Foreign exchange impact (391) (37)
Other items (49) (62)
Change in net debt (2,555) (4,151)
  1.  Excluding restructuring costs

Appendix 6: Simplified consolidated balance sheets

ASSETS
€ million
06/30/15 12/31/14 LIABILITIES & EQUITY
€ million
06/30/15 12/31/14
Property, plant and equipment 10,540 10,396 Equity attributable to equity-holders of sanofi 56,618 56,120
Intangible assets (including goodwill) 55,062 53,740 Equity attributable to non-controlling interests 156 148
Non-current financial assets, investments in associates 5,373 4,959 Total equity 56,774 56,268
Deferred tax assets 4,923 4,860 Long-term debt 10,770 13,276
      Non-current liabilities related to business combinations and to non-controlling interests 1,132 1,133
Non-current assets 75,898 73,955 Provisions and other non-current liabilities 9,206 9,578
Deferred tax liabilities 3,742 4,105
Inventories, accounts receivable and other current assets 17,308 16,086 Non-current liabilities 24,850 28,092
Cash and cash equivalents 4,701 7,341 Accounts payable and other current liabilities 12,192 11,363
Current liabilities related to business combinations and  to non-controlling interests 141 131
Short-term debt and current portion of long-term debt 3,962 1,538
Current assets 22,009 23,427 Current liabilities 16,295 13,032
Assets held for sale or exchange 16 10 Liabilities related to assets held for sale or exchange 4
Total ASSETS 97,923 97,392 Total LIABILITIES & EQUITY 97,923 97,392

Appendix 7: 2015 currency sensitivity

2015 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 0.03
Russian Ruble +10 RUB/EUR -EUR 0.06

Currency exposure on Q2 2015

Currency Q2 2015
US $ 35.6%
Euro € 23.0%
Japanese Yen 5.5%
Chinese Yuan 5.4%
Brazilian Real 3.2%
British Pound 2.0%
Russian Ruble 1.6%
Canadian $ 1.5%
Australian $ 1.5%
Mexican Peso 1.4%
Others 19.3%

Currency average rates

  Q2 2014 Q2 2015 Change Average June 2015
€/$ 1.37 1.10 -20% 1.12
€/Yen 140.03 134.14 -4% 138.74
€/Yuan 8.54 6.85 -20% 6.96
€/Ruble 47.96 58.12 +21% 61.24

Appendix 8: R&D Pipeline

Registration

N
Praluent® (alirocumab)
Anti-PCSK9 mAb
Hypercholesterolemia, EU
 

Dengue
Mild-to-severe
dengue fever vaccine
N
lixisenatide
GLP-1 agonist
Type 2 diabetes, U.S.
PR5i
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine, U.S., EU

Phase III


LixiLan

lixisenatide + insulin glargine
Fixed-Ratio / Type 2 diabetes
N
patisiran (ALN-TTR02)
siRNA inhibitor targeting TTR
Familial amyloid polyneuropathy

Clostridium difficile
Toxoid vaccine
N
SAR342434
insulin lispro
Type 1+2 diabetes
N
revusiran (ALN-TTRsc)
siRNA inhibitor targeting TTR
Familial amyloid cardiomyopathy

Rotavirus

Live attenuated tetravalent
Rotavirus oral vaccine
N
sarilumab
Anti-IL6R mAb
Rheumatoid arthritis

Kynamro® (mipomersen)
Apolipoprotein B-100 antisense
Severe HeFH, U.S.

VaxiGrip® QIV IM
Quadrivalent inactivated
influenza vaccine
N
dupilumab
Anti-IL4R alpha mAb
Atopic dermatitis, Asthma

Jevtana
® (cabazitaxel)
Metastatic prostate cancer (1L)

SYNVISC-ONE
®
Medical device
Pain in hip OA
   

Phase II


dupilumab

Anti-IL4R alpha mAb
Nasal polyposis;
Eosinophilic oesophagitis
N
isatuximab
Anti-CD38 naked mAb
Multiple myeloma

Rabies VRVg

Purified vero rabies vaccine

N
vatelizumab
Anti-VLA 2 mAb
Multiple sclerosis
N
SAR125844
C-MET kinase inhibitor
NSCLC

Meninge ACYW conj.

2nd generation meningococcal
conjugate infant vaccine
N
SAR156597
 IL4/IL13 Bi-specific mAb
Idiopathic pulmonary fibrosis
N
GZ402671
Oral GCS Inhibitor
Fabry Disease

Tuberculosis

Recombinant subunit vaccine

sarilumab

Anti-IL6R mAb
Uveitis
N
olipudase alfa
rhASM
 Niemann-Pick type B
 
N
Combination
ferroquine / OZ439
Antimalarial
 

Phase I

N
GZ402668
GLD52 (anti-CD52 mAb)
Relapsing multiple sclerosis
N
SAR566658
Maytansin-loaded anti-CA6 mAb
Solid tumors
N
GZ402666
neo GAA
Pompe Disease
N
SAR113244
Anti-CXCR5 mAb
Systemic lupus erythematosus
N
SAR408701
Anti-CEACAM5 ADC
Solid tumors
N
GZ389988
TRKA antagonist
Osteoarthritis
N
SAR228810
Anti-protofibrillar AB mAb
Alzheimer’s disease
N
REGN2810
PD-1 inhibitor
Cancer
N
StarGen®
Gene therapy
Stargardt disease
N
SAR425899
GLP-1 / GCGR agonist
Diabetes
SAR125844
C-MET kinase inhibitor
Solid tumors

 
N
UshStat®
Gene therapy
Usher syndrome 1B
N
SAR439152
Myosin inhibitor
Hypertrophic cardiomyopathy

 
 
Streptococcus pneumonia

Meningitis & pneumonia vaccine
 
Herpes Simplex Virus Type 2

HSV-2 vaccine

N : New molecular entity

Appendix 9: Expected R&D milestones

Product Event Timing
Praluent® (alirocumab) Expected EC regulatory approval in Hypercholesterolemia Q3 2015
LixiLan Expected Phase III top line results in Diabetes Q3 2015
Vaxigrip® QIV IM (3+ years) Expected EU regulatory submission Q4 2015
Dengue vaccine Expected regulatory decision in endemic countries Q4 2015
LixiLan Expected U.S. regulatory submission in Diabetes Q4 2015
Sarilumab Expected U.S. regulatory submission in Rheumatoid Arthritis Q4 2015
PR5i vaccine (DTP-HepB-Polio-Hib) Expected U.S. regulatory decision Q4 2015
LixiLan Expected EU regulatory submission in Diabetes Q1 2016
Dupilumab Expected start of Phase III trial in Nasal Polyposis Q1 2016
PR5i vaccine (DTP-HepB-Polio-Hib) Expected EU regulatory decision Q1 2016
Meningitis ACYW conj. vaccine Expected start of Phase III trial Q1 2016
Dupilumab Expected Phase III top line results in Atopic Dermatitis Q1 2016
Rotavirus vaccine Expected regulatory submission in India Q2 2016
Insulin lispro Expected Phase III top line results in Diabetes Q2 2016
Lixisenatide Expected U.S. regulatory decision in Diabetes Q3 2016

Appendix 10: Definitions of non-GAAP financial indicators

Net 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 reported net sales to net sales at constant exchange rates for the second quarter and the first half of 2015

€ million Q2 2015 H1 2015
Net sales 9,378 18,188
Effect of exchange rates -910 -1,692
Net sales at constant exchange rates 8,468 16,496

Net sales on a constant structure basis

We eliminate the effect of changes in structure by restating prior-period net sales as follows:

  • by including sales from the acquired entity or product rights for a portion of the prior period equal to the portion of the current period during which we owned them, based on sales information we receive from the party from whom we make the acquisition;
  • similarly, by excluding sales in the relevant portion of the prior period when we have sold an entity or rights to a product;
  • for a change in consolidation method, by recalculating the prior period on the basis of the method used for the current period.

Business net income

Sanofi publishes a key non-GAAP indicator. This indicator “Business net income”, replaced “adjusted net income excluding selected items”.

Business net income is defined as net income attributable to equity holders of Sanofi excluding:

  • amortization of intangible assets,
  • impairment of intangible assets,
  • fair value remeasurement of contingent consideration liabilities related to business combinations,
  • other impacts associated with acquisitions (including impacts of acquisitions on associates),
  • restructuring costs(1),
  • other gains and losses (including gains and losses on disposals of non-current assets(1)),
  • costs or provisions associated with litigation(1),
  • tax effects related to the items listed above as well as effects of major tax disputes.
  • tax (3%) on dividends paid to Sanofi shareholders.
  1. Reported in the line items Restructuring costs and Gains and losses on disposals, and litigation, which are defined in Note B.20. to our consolidated financial statements.