Sanofi - Sanofi delivered 2015 business EPS up 8.5% on a reported basis and stable at constant exchange rates consistent with guidance

OREANDA-NEWS. Sanofi delivered 2015 business EPS up 8.5% on a reported basis and stable at constant exchange rates consistent with guidance.

Executing on 2020 strategic roadmap
  • Key milestone in reshaping the portfolio with announcement of exclusive negotiations on business swap
  • Significant R&D alliances in oncology and diabetes
  • Praluent® launch progressing with significant U.S. market access for 2016
  • Toujeo®  available globally in over 20 countries, reaching sales of €98 million in Q4 2015
Recent achievements in advancing Sanofi's R&D pipeline of innovative medicines
  • Dengvaxia®, the world's first dengue vaccine, approved in Mexico, Brazil, El Salvador and the Philippines
  • Biologics License Application for sarilumab accepted for review by the FDA
  • FDA submission for priority review of once-daily combination of insulin glargine and lixisenatide
Sales growth in Pharmaceuticals, Vaccines and Animal Health in 2015
  • Aggregate Group sales up 2.2% (+9.7% at 2015 exchange rates) to €37,057 million
  • Genzyme continues to be a key driver with sales up 29.5% with strong momentum in multiple sclerosis
  • Vaccines sales were up 7.3% benefiting from double-digit growth in Emerging Markets(4)
  • Diabetes sales decreased 6.8% in line with October guidance, reflecting lower U.S. sales of Lantus®
  • Animal Health demonstrated strong performance with sales up 10.8% driven by NexGard®
  • Emerging Markets Aggregate sales increased 7.8%, driven by strong growth in China, up 19.5%
Solid financial results in 2015 while making significant investments in new product launches
  • Business EPS was €5.64, up 8.5% on a reported basis and stable at CER
  • Free Cash Flow up 12.2% to €8,132 million resulting in net debt of €7,254 million
  • Board proposes dividend of €2.93, the 22nd consecutive year of dividend growth
2016 financial guidance
  • Sanofi expects 2016 Business EPS to be broadly stable at CER, barring unforeseen major adverse events

Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"In 2015, Sanofi made meaningful progress with key launches, multiple business development activities and our efforts to simplify the organization. Entering into exclusive negotiations on a business swap with Boehringer Ingelheim would bring us leadership in CHC. This is a key first step in reshaping our portfolio. In 2016, we continue to allocate resources to our promising late-stage pipeline and the introduction of innovative medicines which will position us for accelerated future growth".

  Q4 2015 Change Change (CER) 2015 Change Change (CER)
Aggregate Group sales €9,278m +2.3% -1.6% €37,057m +9.7% +2.2%
Business net income €1,709m -6.5% -13.5% €7,371m +7.7% -0.9%
Business EPS €1.31 -5.8% -12.9% €5.64 +8.5% 0.0%
IFRS net sales reported €8,719m +1.8% -2.0% €34,542m +9.0% +1.6%
IFRS net income reported €334m -75.1%   €4,287m -2.3%  
IFRS EPS reported €0.26 -74.5%   €3.28 -1.8%  


Fourth-quarter Aggregate Group sales were €9,278 million up 2.3% at 2015 exchange rates. Exchange rate movements had a positive effect of 3.9 percentage points reflecting mainly the strength of the U.S. dollar against the Euro, which largely offset the negative effect of the Brazilian real and the Russian Ruble. At CER, Aggregate Group sales decreased 1.6%.This includes the impact of the voluntary recall of Auvi-Q®/Allerject® in the U.S. and Canada announced on October 30. The negative impact of the recall on sales was -€122 million which corresponded mainly to the reversal of sales of the product since the beginning of 2015. Excluding AuviQ®/Allerject®, Aggregate Group sales were down 0.3% at CER.

In 2015, Aggregate Group sales were €37,057 million, up 9.7% at 2015 exchange rates. Exchange rate movements had a favorable effect of 7.5 percentage points resulting in an increase of aggregate Group sales of 2.2% at CER.

€ million Q4 2015 Change
(CER)
2015 Change
(CER)
Pharmaceuticals   7,277   -4.7% 29,799 +0.8%
Diabetes   1,903   -12.6% 7,580 -6.8%
Genzyme   1,013   +28.2% 3,664 +29.5%
Consumer Healthcare (CHC)   809   +1.0% 3,492 +2.8%
Generics   467   +4.7% 1,917 +7.6%
Oncology   381   -7.9% 1,504 -1.9%
Established Rx Products   2,699   -10.4% 11,633 -2.3%
Vaccines   1,442   +15.0% 4,743 +7.3%
Animal Health   559   +5.9% 2,515 +10.8%
Total Aggregate Group sales   9,278   -1.6% 37,057 +2.2%

Pharmaceuticals

Fourth-quarter sales for Pharmaceuticals decreased 4.7% to €7,277 million impacted by a decline in Diabetes and Established Rx Products that was partially offset by Genzyme. Excluding AuviQ®/Allerject®, sales for Pharmaceuticals were down 3.2%. In 2015, sales for Pharmaceuticals increased 0.8% to €29,799 million.

Diabetes

€ million Q4 2015
 net sales
Change
(CER)
2015
 ne
t sales
Change
(CER)
Lantus® 1,536 -19.9% 6,390 -10.8%
Amaryl® 94 0.0% 393 +1.7%
Apidra® 104 +3.1% 376 +4.8%
Toujeo® 98 - 164 -
Insuman® 38 0.0% 141 +2.9%
BGM (Blood Glucose Monitoring) 16 -11.1% 63 -1.6%
Lyxumia® 11 +25.0% 38 +37.0%
Afrezza® 2 - 7 -
Total Diabetes 1,903 -12.6% 7,580 -6.8%

In the fourth quarter, sales of Diabetes decreased 12.6% to €1,903 million, reflecting lower sales of Lantus® in the U.S. In 2015, sales of Diabetes were €7,580 million, down 6.8% and in line with the guidance communicated in October.

In the U.S., fourth-quarter sales of Diabetes were down 25.1% to €1,056 million. Sales of Diabetes outside the U.S. were €847 million, an increase of 7.0% supported by the strong performance in Emerging Markets up 15.1% to €426 million. Sales in Western Europe reached €302 million, up 1.0% reflecting glargine biosimilar competition.

Toujeo®, the new-generation basal insulin, was launched in the U.S. market at the end of March and later in the year in other key global markets. Total sales of the product were €98 million in the fourth quarter compared to €46 million in the third quarter of 2015. In the U.S. sales of Toujeo® were €79 million reflecting strong adoption by prescribers supported by rapid and broad commercial and Medicare market access. Toujeo® is now available globally in more than 20 countries and generated full year 2015 sales of €164 million including €27 million outside the U.S.

Fourth-quarter sales of Sanofi's glargine franchise (Lantus® and Toujeo®) were €1,634 million, down 14.9%. Over the quarter, sales of Lantus® were €1,536 million down 19.9 %. In the U.S., as anticipated, sales of Lantus® decreased 31.6% to €933 million mainly reflecting higher discounts as compared to last year, a slowdown of basal insulin market growth and an unfavorable mix effect towards highly-discounted government channels such as Medicaid (which also included Medicaid delayed bills from multiple States). In Western Europe, sales of Sanofi's glargine franchise were up 0.4% to €231 million reflecting the launch of a biosimilar glargine in the second half of 2015 in several European markets. In Emerging Markets, fourth-quarter sales of Sanofi's glargine franchise were €304 million, up 17.2%, driven by Lantus® in China, Middle East, Russia and Turkey. In 2015 sales of Sanofi's glargine franchise were €6,554 million, down 8.5%.

Fourth-quarter sales of Amaryl® were stable at €94 million, of which €76 million were generated in Emerging Markets (up 4.2%). In 2015, Amaryl® sales were up 1.7% to €393 million. Fourth-quarter sales of Apidra® increased 3.1% to €104 million, reflecting lower sales in the U.S. (-12.2% to €42 million). In Emerging Markets, sales of Apidra® increased 19.0% to €24 million. In 2015, sales of Apidra® were up 4.8% to €376 million.

Afrezza® sales were €2 million and €7 million in the fourth quarter and 2015, respectively. On January 4, 2016, Sanofi informed MannKind Corporation, that it has exercised its option to terminate its agreement. This termination will become effective on April 4, 2016. This action is in line with the terms of the contract, and the decision to terminate is due to a number of factors, including the continued low level of prescriptions for Afrezza® despite Sanofi's substantial efforts. Sanofi intends to work with MannKind to support a smooth transition and will continue to make Afrezza® available in the United States for a period of up to approximately 180 days after the date of Termination, as set forth in the License and Collaboration Agreement.

Praluent®

Following European approval in September 2015, Praluent® (alirocumab, collaboration with Regeneron) was launched in the UK, Germany and Nordic countries in the fourth quarter. In the U.S., Praluent® was launched in July and is now accessible on formularies covering over 170 million lives in the U.S. In addition to the significant market access achieved, Praluent® is the only PCSK9 inhibitor preferred across UnitedHealth Group formularies. Worldwide sales of Praluent® were €5 million and €9 million in the fourth quarter and full year of 2015, respectively.

Genzyme

€ million Q4 2015
net sales
Change
(CER)
2015
net sales
Change
(CER)
Cerezyme® 180 -9.6% 757 +1.3%
Myozyme® / Lumizyme® 167 +6.7% 650 +12.4%
Fabrazyme® 158 +20.3% 592 +17.2%
Aldurazyme® 49 +6.7% 195 +8.7%
Cerdelga® 22 - 66 -
Total Rare Diseases 660 +8.4% 2,550 +11.4%
Aubagio® 272 +69.9% 871 +77.8%
Lemtrada® 81 - 243 -
Total Multiple Sclerosis 353 +99.4% 1,114 +112.2%
Total Genzyme 1,013 +28.2% 3,664 +29.5%

Fourth-quarter sales of Genzyme increased 28.2% to €1,013 million driven by Aubagio® and the launch progress of Lemtrada®. Genzyme delivered strong performance across all geographies with the U.S. up 42.1% to €485 million and Western Europe up 25.3% to €290 million over the period. In Emerging Markets, sales were €148 million, up 9.7% in the fourth quarter. In 2015, sales of Genzyme increased 29.5% to €3,664 million.
Sales of Multiple Sclerosis products increased 99.4% to €353 million in the fourth quarter. In 2015, sales of this franchise grew 112.2% exceeding €1 billion in annual sales for the first time (€1,114 million).

Fourth-quarter sales of Aubagio® were up 69.9% to €272 million driven by the U.S. (up 57.4% to €194 million) and Western Europe (€58 million in sales). In Western Europe, Aubagio® exceeded 15% market share in France and some Nordic countries. In 2015, sales of Aubagio® increased 77.8% to €871 million.

Fourth-quarter sales of Lemtrada® were €81 million including €44 million in the U.S. and €28 million in Western Europe, mainly in Germany and the UK. In 2015, sales of Lemtrada® were €243 million compared to €34 million in 2014.

Sales of Rare Disease products were up 8.4% to €660 million in the fourth quarter and 11.4% to €2,550 million in 2015.

Sales of the Gaucher franchise reached €202 million in the fourth quarter, down 1.5% and reflecting lower sales in Emerging markets of Cerezyme® (€59 million, down 14.7%) due to lower Russian government purchasing. In the U.S., fourth-quarter sales of the Gaucher franchise increased 11.5% to €66 million reflecting decreased sales of Cerezyme® (€47 million, down 12.5%) which were more than offset by Cerdelga® sales (€19 million versus €4 million in Q4 2014), the only first-line oral therapy for Gaucher disease type 1 patients. In Western Europe, where Cerdelga® is now available in several countries (Germany, France, Denmark, Norway and Sweden), sales of the Gaucher franchise were €64 million, up 3.2%. In 2015, sales of the Gaucher franchise increased 8.6% to €823 million, mainly reflecting new patient accrual by Cerdelga®.

Fourth-quarter sales of Fabrazyme® increased 20.3% to €158 million. The product recorded strong performance in the U.S. (up 20.3% to €82 million), Western Europe (up 17.2% to €35 million), and Emerging Markets (up 46.7% to €19 million) reflecting new patient accrual. In 2015, sales of Fabrazyme® increased 17.2% to €592 million.

Sales of Myozyme®/Lumizyme® were €167 million, an increase of 6.7% in the fourth quarter, driven by the U.S. (up 9.3% to €55 million) and Emerging markets (up 11.5% to €28 million). In Western Europe, sales were stable at €72 million. In 2015, sales of Myozyme®/Lumizyme® were €650 million, an increase of 12.4%.

Consumer Healthcare

€ million Q4 2015
net sales
Change
(CER)
2015
net sales
Change
(CER)
Allegra® 75 -5.4% 424 +8.0%
Doliprane® 83 +6.4% 303 -2.3%
Essentiale® 55 +1.6% 196 -6.4%
Enterogermina® 35 +5.9% 161 +1.3%
Nasacort® 21 -17.4% 122 -8.8%
Lactacyd® 20 -4.3% 114 +10.6%
Maalox® 22 -8.0% 97 +4.1%
No Spa® 22 -4.0% 88 -5.5%
Magne B6® 20 +9.1% 82 +9.1%
Dorflex® 17 +4.5% 81 +6.7%
Other CHC Products 439 +2.1% 1,824 +4.2%
Total Consumer Healthcare 809 +1.0% 3,492 +2.8%

Sales of Consumer Healthcare (CHC) products were €809 million in the fourth quarter, an increase of 1.0% driven by higher sales in Australia and Mexico. Over the quarter, sales of CHC in the U.S. were up 0.6% to €197 million reflecting lower sales of Nasacort® compared to strong sales following the product launch in 2014. Fourth-quarter sales of CHC in Emerging Markets were stable at €392 million, with lower sales in Venezuela offsetting the recovery in Mexico. In Western Europe, sales were flat at €159 million in the quarter, impacted by a second price decrease of Doliprane® in France in November. In the Rest of the World, fourth-quarter sales grew 12.5% to €61 million driven by Australia. In 2015, sales of CHC reached €3,492 million, an increase of 2.8%.

Generics

Fourth-quarter sales of Generics increased 4.7% to €467 million driven by sales in Western Europe (up 9.8% to €150 million) and sales of authorized generics version of Lovenox® in the U.S. and Plavix® in Japan. In Emerging Markets, fourth-quarter sales of Generics were €258 million, down 1.0% reflecting lower sales in Brazil. In 2015, sales of Generics increased 7.6% to €1,917 million.

Oncology

€ million Q4 2015
net sales
Change
(CER)
2015
net sales
Change
(CER)
Jevtana® 84 +8.1% 321 +9.5%
Thymoglobulin® 69 +12.3% 256 +6.0%
Eloxatin® 58 -24.3% 227 -0.5%
Taxotere® 49 -33.8% 222 -22.2%
Mozobil® 38 +12.9% 143 +16.2%
Zaltrap® 18 -10.0% 77 +5.8%
Total Oncology 381 -7.9% 1,504 -1.9%

Fourth-quarter sales of Oncology were €381 million, down 7.9% impacted by lower sales of Eloxatin® in the U.S. In 2015, sales of Oncology were €1,504 million, down 1.9%.

Sales of Jevtana® increased 8.1% to €84 million in the fourth quarter led by the U.S. (up 19.2% to €35 million) and Japan where the product was launched in September 2014. In 2015, sales of Jevtana® were up 9.5% to €321 million.

Sales of Thymoglobulin® were up 12.3% to €69 million and 6.0% to €256 million in the fourth quarter and 2015, respectively.

Fourth-quarter sales of Eloxatin® were down 24.3% (to €58 million) reflecting lower sales in the U.S. which were partially offset by the continued good performance in China. Over the same period, sales of Taxotere® decreased 33.8% (to €49 million), reflecting generic competition especially in Japan. In 2015, sales of Eloxatin® and Taxotere® were down 0.5% (€227 million) and down 22.2% (€222 million), respectively. A generic of Eloxatin® was recently introduced in Canada.

Sales of Mozobil® grew 12.9% (to €38 million) and 16.2% (to €143 million) in the fourth quarter and in 2015, respectively.

Established Rx Products

€ million Q4 2015
net sales
Change
(CER)
2015
net sales
Change
(CER)
Plavix® 455 -14.2% 1,929 -4.1%
Lovenox® 419 -3.4% 1,719 -0.5%
Renvela®/Renagel® 239 +0.9% 935 +18.9%
Aprovel®/Avapro® 170 -7.9% 762 -3.7%
Synvisc® /Synvisc-One® 116 +4.0% 413 +2.3%
Multaq® 85 0.0% 341 +0.7%
Myslee®/Ambien®/Stilnox® 85 +2.6% 306 -6.2%
Allegra® 44 +2.4% 194 -3.6%
AuviQ®/Allerject® -118   -5  
Other 1,204 -7.7% 5,039 -3.5%
Total Established Rx Products 2,699 -10.4% 11,633 -2.3%

Fourth-quarter sales of Established Rx Products were €2,699 million, down 10.4%. Excluding AuviQ®/Allerject®, sales of Established Rx Products were down 6.5%.

Sales of Plavix® decreased 14.2% to €455 million in the fourth quarter reflecting generic competition in Japan beginning in June 2015 (sales in Japan were down 36.5% to €144 million), which was partially offset by continued strong performance in China (up 17.0% to €174 million). In 2015, Plavix® decreased 4.1% to €1,929 million with sales in Japan of €695 million (down 12.5%) and China of €660 million (up 13.1%).

Sales of Lovenox® were €419 million in the fourth quarter, down 3.4% impacted by generic competition in the U.S. In Emerging Markets and in Western Europe, sales of Lovenox were up 2.0% (to €151 million) and stable (at €227 million), respectively. Sanofi is aware of competitors that have filed marketing authorization applications for biosimilar enoxaparin with health authorities in Europe. In 2015, sales of Lovenox® were €1,719 million (down 0.5%).

Sales of Renvela®/Renagel® were €239 million in the fourth quarter, up 0.9%. In the U.S., sales of the product increased 6.9% to €193 million. Generics of the product are currently marketed in some European countries, which resulted in Western Europe sales of Renvela®/Renagel® down 36.1% to €23 million. Sanofi continues to expect potential generic approvals in the U.S. in 2016. Sales of Renvela®/Renagel® were €935 million, up 18.9% in 2015.

Fourth-quarter sales of Aprovel®/Avapro® were down 7.9% to €170 million due generic competition in Western Europe (down 16.3% to €36 million). In Emerging Markets, sales of the product were down 2.0% to €100 million. The positive performance in China (up 17.8% to €58 million) was partially offset by lower sales in Venezuela and the Middle-East. In 2015, sales of Aprovel®/Avapro® were €762 million (down 3.7%).

On October 30, Sanofi announced a voluntary recall for Auvi-Q® and Allerject® in the U.S. and Canada. The negative impact of the recall on sales was -€122 million which corresponded mainly to the reversal of sales of the product since the beginning of 2015.

Vaccines

€ million Q4 2015
net sales
Change
(CER)
2015
net sales
Change
(CER)
Influenza Vaccines
(incl. Vaxigrip® and Fluzone®)
450 +25.1% 1,322 +2.0%
Polio/Pertussis/Hib Vaccines
(incl. Pentacel®, Pentaxim® and Imovax®)
466 +13.5% 1,348 +8.1%
Meningitis/Pneumonia Vaccines
(incl. Menactra®)
112 +9.8% 614 +16.7%
Adult Booster Vaccines (incl. Adacel ®) 150 +35.0% 496 +10.1%
Travel and Other Endemic Vaccines 100 -2.0% 375 -6.9%
Other Vaccines 164 -3.4% 588 +19.9%
  Of which VaxServe 135 +4.4% 481 +28.7%
Total Vaccines
(consolidated sales)
1,442 +15.0% 4,743 +7.3%

Fourth-quarter consolidated sales of Sanofi Pasteur were up 15.0% to €1,442 million driven by influenza and Adult Booster vaccines and Meningitis/Pneumonia Vaccines  in the U.S. as well as Polio/Pertussis/Hib Vaccines in Emerging Markets. In the quarter, sales of Sanofi Pasteur increased 4.4% to €776 million in the U.S. and 24.0% to €531 million in Emerging Markets. In 2015, sales of Sanofi Pasteur increased 7.3% to €4,743 million.

Sales of Influenza Vaccines increased 25.1% to €450 million in the fourth quarter benefiting from a favorable phasing in the U.S., Mexico, Middle-East, and Western Europe. In the U.S., sales of Influenza vaccines increased 30.4% to €322 million. Sales in Emerging Markets were up 8.5% to €109 million. In 2015, sales of Influenza vaccines increased 2.0% to €1,322 million of which €896 million in the U.S. (up 11.8%) reflecting Sanofi Pasteur's strategy to offer differentiated influenza vaccines. This performance was partially offset by lower sales in Brazil due to increased supply of the Butantan Institute.

Fourth quarter sales of Polio/Pertussis/Hib Vaccines increased 13.5% to €466 million driven by sales of Pentaxim® in China, Hexaxim® in Middle-East and sales of Hib vaccines in Japan resulting from delayed supply by a competitor. In Emerging Markets, sales of Polio/Pertussis/Hib Vaccines increased 45.4% to €317 million over the quarter.
In the fourth quarter, Pentacel® was under supply constraints in the U.S. and sales of Polio/Pertussis/Hib Vaccines were €86 million in the U.S. Supply constraints should continue throughout the first half of 2016. In 2015, sales of Polio/Pertussis/Hib Vaccines increased 8.1% to €1,348 million.

Sales of Menactra® increased 16.3% to €104 million in the fourth quarter driven by booster vaccinations in the U.S. In 2015, Menactra® delivered a strong performance with sales up 18.2% to €563 million.

Fourth-quarter sales of Adult Booster Vaccines increased 35% to €150 million reflecting phasing of Adacel® in the U.S. In 2015, Adult Booster vaccines were €496 million, an increase of 10.1%.

Fourth-quarter and 2015 sales of Travel and Other Endemic Vaccines declined 2.0% to €100 million and 6.9% to €375 million, respectively.

Dengvaxia®, the world's first dengue vaccine, was approved in late 2015 in three countries, Mexico, the Philippines and Brazil and no sales were recorded in Q4 2015.

Sales of Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe, were €240 million (stable on a reported basis) and €824 million (down 2.8% on a reported basis) in the fourth quarter and 2015, respectively.

Animal Health

€ million Q4 2015
net sales
Change
(CER)
2015
net sales
Change
(CER)
Companion Animal 321 +8.7% 1,629 +13.1%
Production Animal 238 +2.6% 886 +7.0%
Total Animal Health 559 +5.9% 2,515 +10.8%
  of which Vaccines 213 0.0% 804 +5.7%
  of which fipronil products 102 -14.9% 627 -4.5%
  of which avermectin products 94 +4.7% 498 +11.1%

Fourth-quarter sales of Animal Health increased 5.9% to €559 million driven by the continued success of NexGard®, Merial's next generation flea and tick product for dogs and by the performance of the Ruminant franchise. In the U.S. and rest of the World, Animal Health sales grew 12.9% (to €219 million) and 14.9% (to €54 million), respectively. In 2015, sales of Animal Health were up 10.8% to €2,515 million driven by the success of NexGard®.

Fourth-quarter sales of the Companion Animals segment were up 8.7% to €321 million reflecting the success of NexGard® which offset the decline of the Frontline® products family. In 2015, NexGard® became the third largest product of Merial. Sales of Companion Animals segment grew 13.1% to €1,629 million.

Fourth-quarter sales of the Production Animals segment increased 2.6% to €238 million driven by the Ruminant business in the U.S reflecting the success of LongRange®.The Avian business was up 1.1% in the fourth quarter of 2015 due to the strong performance in the same period of last year. In 2015, sales of the Production Animals segment grew 7.0% to €886 million.

(7) The Animal Health business is reported on a single line in the consolidated income statements in accordance with IFRS 5 (Non-current assets held for sale and discontinued operations). Sanofi will continue to manage and report the performance of the Animal Health business, which will remain an operating segment consistent with IFRS 8.

Aggregate Group sales by geographic region

€ million Aggregate Q4 2015
 Group sales
Change
(CER)
Aggegate 2015
 Group sales
Change
(CER)
United States 3,292 -8.2% 13,406 -1.0%
Emerging Markets(a) 3,102 +5.5% 12,014 +7.8%
  of which Latin America 780 -3.9% 3,305 +4.0%
  of which Asia 985 +16.2% 3,732 +13.2%
  of which Eastern Europe, Russia and Turkey 640 +4.3% 2,429 +5.4%
  of which Africa and Middle East 625 +4.5% 2,319 +6.8%
Western Europe(b) 2,009 +1.7% 8,026 +0.9%
Rest of the world(c) 875 -9.1% 3,611 -2.5%
  of which Japan 510 -13.8% 2,082 -6.6%
Total Aggregate Group sales 9,278 -1.6% 37,057 +2.2%

(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

Fourth-quarter Aggregate sales in the U.S. were down 8.2% to €3,292 million impacted by a 25.1% decrease in diabetes sales and the recall of Auvi-Q® that were partially offset by the strong performance of Genzyme (up 42.1%), and Animal Health (up 12.9%). Excluding AuviQ®, fourth-quarter sales in the U.S. were down 5.0%. In 2015, Aggregate sales in the U.S. were down 1.0% to €13,406 million.

Aggregate sales in Emerging Markets were up 5.5% to €3,102 million in the fourth quarter reflecting strong performance of Diabetes (up 15.1%), Vaccines (up 24.0%) and Genzyme (up 9.7%). In Asia, Aggregate sales were up 16.2% to €985 million in the fourth quarter boosted by the performance in China (up 26.9% to €604 million).
In China, the strong performance was mainly driven by Vaccines, Plavix®, Lantus®, Aprovel®. In Latin America, fourth-quarter Aggregate sales decreased 3.9% to €780 million reflecting lower Aggregate sales in Brazil (€225 million, down 7.2%) impacted by local economic conditions. Aggregate sales in Eastern Europe, Russia and Turkey increased 4.3% to €640 million in the fourth quarter driven by Turkey and Ukraine. Aggregate Sales in Russia were €168 million, down 0.5% reflecting lower sales of Cerezyme®. In Africa and the Middle East, Aggregate sales were up 4.5% to €625 million sustained by the performance in Middle-East. In 2015, Aggregate sales in the Emerging Markets increased 7.8% to €12,014 million. Full-year Aggregate sales of China, Russia and Brazil were €2,218 million (up 19.5%), €596 million (down 2.6%) and €1,112 million (down 6.2%), respectively.

Fourth-quarter Aggregate sales in Western Europe increased 1.7% to €2,009 million. The strong performance of Genzyme (up 25.3%) and Vaccines was partially offset by lower sales of Established Rx products (-6.6%). In 2015, Aggregate sales in Western Europe increased 0.9% to €8,026 million.

In the fourth quarter, Aggregate sales in Japan decreased 13.8% to €510 million, reflecting generic competition to Plavix® (-36.5%) despite strong growth of Vaccines (+76.0%). In 2015, in Japan, Aggregate sales decreased 6.6% to €2,082 million.