Full Press Release Details
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 | 9,378 | m | +16.1 | % | +4.9 | % | 18,188 | m | +14.3 | % | +3.6 | % | |||
| Business net income(1) | 1,840 | m | +19.7 | % | +4.2 | % | 3,566 | m | +15.6 | % | +2.9 | % | |||
| Business EPS(1) | 1.41 | +20.5 | % | +5.1 | % | 2.73 | +16.7 | % | +3.8 | % | |||||
| IFRS net income reported | 1,302 | m | +67.6 | % | 2,325 | m | +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 | % |
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.
| million | Q2 2015 net sales | Change (CER) | H1 2015 net 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.
| 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 | 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.
| 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%.
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.
| 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%).
| 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.
| 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 | % |
(a) World less the U.S., Canada, Western Europe, Japan, South Korea, Australia and New Zealand;
(b) France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark;
(c) 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.
Consult Appendix 8 for full overview of Sanofi s R&D pipeline
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.
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.