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PRESS RELEASE Paris

Key Takeaway: Solid sales and Business EPS(1) growth at CER in Q2 2014 Growth trajectory continues in the second quarter Group sales(2) up 6.4%(3) to 8,075 million driven by Genzyme (+29.1%) and Diabetes (+16.2%). Growth platforms(4) up 14.5%(3) to 6,163 million, representing 76.3% of total

Full Press Release Details

Solid sales and Business EPS(1) growth at CER in Q2 2014
Growth trajectory continues in the second quarter
Group sales(2) up 6.4%(3) to 8,075 million driven by Genzyme (+29.1%) and Diabetes (+16.2%).
Growth platforms(4) up 14.5%(3) to 6,163 million, representing 76.3% of total sales.
Business net income(1) increased 13.0% at CER to 1,537 million, (+3.9% on a reported basis).
Business EPS(1) grew 13.4% at CER to 1.17.
Free Cash Flow(5) increased 33.1% to 2,390 million in H1 2014.
Strong growth in Emerging Markets and executing on new launches
Emerging Markets(6) sales grew 16.5%(3) to 2,855 million representing 35.4% of total Group sales.
Merial grew 6.2% driven by a strong NexGard launch.
Successful Nasacort OTC launch in the U.S. contributed to CHC sales growth of 9.2%(7).
Significant advances achieved in the R&D pipeline
Positive results from nine Phase III ODYSSEY studies with alirocumab for hypercholesterolemia.
Positive Phase III results for Toujeo presented at ADA; filings submitted in the U.S., EU and Japan.
Strong Phase II data sets with dupilumab in atopic dermatitis; Phase III expected to begin later this year.
New detailed data from a positive Phase III trial with sarilumab in rheumatoid arthritis presented at EULAR.
Lemtrada resubmission in multiple sclerosis accepted for review by the FDA.
Financial guidance for 2014 adjusted
Given our financial performance in H1 2014 and despite increasing U.S. competitive pressure at the payor level, 2014 business EPS is expected to be between 6% to 8% higher than 2013 at CER(1), barring major unforeseen adverse events.
Sanofi Chief Executive Officer, Christopher A. Viehbacher commented:
Our solid second quarter performance reflects consistent execution of our growth strategy and allows us to slightly adjust upwards our 2014 financial guidance. This quarter, growth platforms represented more than 75% of our sales. Based on the solid momentum in our late stage pipeline, we are actively preparing for a wave of new product launches that will further redefine Sanofi as a biopharmaceutical leader.
(1) See Appendix 10 for definitions of financial indicators; (2) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 10 for a definition); (3) Excluding generics in Brazil, Group sales grew 3.9%, growth platforms grew 10.7% and Emerging Markets grew 8.6%; (4) See page 2; (5) Free Cash Flow after capital expenditures; (6) See definition on page 10; (7) Including the change of category, sales of CHC grew 20.2%.
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2014 second-quarter and first-half key figures
Q2 2014 Change (reported) Change (CER) H1 2014 Change (reported) Change (CER)
Net sales 8,075 m +0.9 % +6.4 % 15,917 m -0.9 % +4.9 %
Business net income(1) 1,537 m +3.9 % +13.0 % 3,084 m +0.2 % +9.2 %
Business EPS(1) 1.17 +4.5 % +13.4 % 2.34 +0.9 % +9.9 %
In order to facilitate an understanding of our operational performance, Sanofi comments on the business net income statement. Business net income(1) is a non-GAAP financial measure. The consolidated income statement for H1 2014 is provided in Appendix 4 and a reconciliation of business net income to consolidated net income in Appendix 3. Consolidated net income for H1 2014 was 1,861 million compared to 1,437 million for H1 2013. Consolidated EPS for H1 2014 was 1.41 versus 1.09 for H1 2013.
2014 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 2014, Sanofi sales were 8,075 million, an increase of 0.9% on a reported basis. Exchange rate movements had a negative effect of 5.5 percentage points primarily reflecting the strength of the euro versus other currencies, in particular the U.S. Dollar.
First-half sales reached 15,917 million, a decrease of 0.9% on a reported basis. Exchange rate movements had an unfavorable effect of 5.8 percentage points.
In the second quarter, sales of the Group s growth platforms totaled 6,163 million, an increase of 14.5%, driven by the performance of Emerging Markets (up 16.5%), Genzyme (up 29.1%) and Diabetes (up 16.2%). Excluding generics in Brazil which were impacted in the second quarter of 2013 by an adjustment of 122 million, growth platforms grew 10.7%. The Group s growth platforms accounted for 76.3% of total consolidated sales in the second quarter, up from 71.5% in the second quarter of 2013. First-half sales of growth platforms reached 11,939 million, an increase of 11.2%, and accounted for 75.0% of total consolidated sales compared with 71.3% in the first half of 2013. Excluding generics in Brazil, sales of growth platforms grew 9.0% in the first half of 2014.
million Q2 2014 net sales Change (CER) H1 2014 net sales Change (CER)
Diabetes 1,788 +16.2 % 3,450 +14.7 %
Consumer Healthcare (CHC) 816 +20.2 % 1,701 +19.4 %
Vaccines 718 -0.4 % 1,346 -2.2 %
Genzyme 643 +29.1 % 1,209 +25.4 %
Animal Health 537 +6.2 % 1,054 +2.2 %
Other Innovative Products(a) 189 +13.3 % 379 +17.8 %
Emerging Markets(b) 2,855 +16.5 %(c) 5,445 +11.0 %(c)
of which Diabetes, Vaccines, CHC, Animal Health, Genzyme and Other Innovative Products 1,383 +17.8 % 2,645 +15.1 %
of which other products 1,472 +15.3 % 2,800 +7.3 %
Total Growth Platforms 6,163 +14.5 % 11,939 +11.2 %
(a) Includes recent product launches which do not belong to the other Growth Platforms listed above: Multaq , Jevtana , Zaltrap , Auvi-Q and Mozobil .
(b) World excluding the U.S. and Canada, Western Europe, Japan, Australia and New Zealand.
(c) Excluding generics in Brazil, sales in Emerging Markets grew 8.6% in Q2 2014 and 6.5% in H1 2014.
(1) See Appendix 10 for definitions of financial indicators.
Second-quarter sales for the Pharmaceuticals business grew 7.2% to 6,820 million, reflecting strong performance in the U.S. and Emerging Markets. Excluding generics in Brazil, sales of Pharmaceuticals increased 4.1%. First-half sales for Pharmaceuticals grew 5.9% to 13,517 million. Excluding generics in Brazil, sales for Pharmaceuticals grew 4.2% in the first half of 2014.
million Q2 2014 net sales Change (CER) H1 2014 ne t sales Change (CER)
Lantus 1,557 +16.3 % 3,005 +14.9 %
Amaryl 96 +4.0 % 182 +2.1 %
Apidra 77 +19.1 % 152 +19.4 %
Insuman 33 +6.3 % 65 +4.6 %
BGM (Blood Glucose Monitoring) 16 +33.3 % 32 +39.1 %
Lyxumia 6 11
Total Diabetes 1,788 +16.2 % 3,450 +14.7 %
Diabetes division sales grew 16.2% to 1,788 million in the second quarter driven by Lantus (up 16.3% to 1,557 million). First-half sales of the Diabetes division grew 14.7% to 3,450 million. In the second quarter, in the U.S., Lantus sales increased 20.3% to 1,035 million and Lantus SoloSTAR represented 61.3% of total Lantus sales, versus 56.4% for the same period in 2013. In Emerging Markets, Lantus sales reached 243 million in the second quarter, an increase of 16.1% reflecting good performance in China, Turkey, Middle East and in some Latin American countries. First-half sales of Lantus reached 3,005 million, up 14.9%.
Amaryl sales were 96 million, an increase of 4.0%. In Emerging Markets, Amaryl continued to deliver good performance with sales up 16.9% to 77 million. First-half sales of Amaryl were 182 million (up 2.1%).
Second-quarter Apidra sales grew 19.1% to 77 million driven by the U.S. (up 21.7% to 27 million) and Emerging Markets (up 31.3% to 18 million). First-half sales of Apidra increased 19.4% to 152 million.
Lyxumia is now available in a number of countries such as Japan, the U.K., Italy, Spain and Mexico, with additional launches expected in 2014. Second-quarter sales of Lyxumia were 6 million. In June 2014, the German arbitration board set a new reimbursement level for Lyxumia . On the basis of this decision, Sanofi has not resumed the sale of Lyxumia in Germany. Sanofi is confident in the benefit/risk profile of Lyxumia and the value it can bring to patients and has decided to file legal action against the adjudication. First-half sales of Lyxumia reached 11 million.
million Q2 2014 net sales Change (CER) H1 2014 net sales Change (CER)
Allegra 94 +53.8 % 198 +29.9 %
Doliprane 70 +4.4 % 158 +6.0 %
Essentiale 55 +10.5 % 121 +26.9 %
Enterogermina 36 +31.0 % 74 +16.2 %
Nasacort 26 68
Lactacyd 32 +41.7 % 57 +25.5 %
No Spa 25 +20.8 % 53 +11.1 %
Dorflex 27 +55.0 % 50 +28.3 %
Maalox 23 +4.3 % 50 +12.5 %
Other CHC Products 428 +9.8 % 872 +10.8 %
Total Consumer Healthcare 816 +20.2 % 1,701 +19.4 %
Second-quarter Consumer Healthcare products (CHC) recorded sales of 816 million, an increase of 20.2%. Several products (amounting 73 million in sales) previously recorded in prescription pharmaceuticals in the second quarter of 2013 were transferred to Consumer Healthcare products. Excluding this category change, sales of CHC grew 9.2% reflecting the success of the Nasacort Rx-to-OTC switch in the U.S. and strong
performance in Emerging Markets (+12.9%). Dorflex , Lactacyd Enterogermina and No Spa recorded double-digit growth in sales over the period. Sales of Nasacort Allergy 24HR nasal spray, which has been available over-the-counter (OTC) in the U.S. since February, were 21 million in the second quarter in the U.S.
First-half sales of CHC reached 1,701 million, an increase of 19.4%. Excluding the category change mentioned above ( 141 million in the first half of 2013), sales of CHC grew 9.3%.
million Q2 2014 net sales Change (CER) H1 2014 net sales Change (CER)
Cerezyme 175 +9.9 % 343 +7.9 %
Myozyme / Lumizyme 133 +10.3 % 254 +9.1 %
Fabrazyme 123 +44.0 % 221 +28.4 %
Aldurazyme 45 +17.1 % 86 +16.7 %
Total Rare Diseases 540 +15.9 % 1,023 +12.2 %
Aubagio 97 +209.1 % 175 +245.3 %
Lemtrada 6 11
Total Multiple Sclerosis 103 +227.3 % 186 +266.0 %
Total Genzyme 643 +29.1 % 1,209 +25.4 %
Second-quarter sales of Genzyme grew 29.1% to 643 million, driven by the growth of Aubagio and Fabrazyme . Sales grew 27.3% (to 235 million) in the U.S., 47.3% (to 144 million) in Emerging Markets and 22.9% (to 209 million) in Western Europe. First-half sales of Genzyme increased 25.4% to 1,209 million.
Sales of Cerezyme increased 9.9% to 175 million in the second quarter driven by Emerging Markets (up 19.3% to 59 million). Sales of Cerezyme grew 7.1% (to 60 million) and 6.7% (to 45 million) in Western Europe and the U.S., respectively. The global market share of Cerezyme in value was 73% in the second quarter. First-half sales of Cerezyme increased 7.9% to 343 million.
In the second quarter, Fabrazyme delivered strong performance with sales of 123 million, up 44.0% driven by Emerging Markets where sales reached 27 million versus 8 million in the second quarter of 2013. In Western Europe, Fabrazyme continued to gain market share from the competitive product and recorded strong performance with sales increasing 33.3% to 28 million. In the U.S., sales of Fabrazyme reached 55 million, an increase of 16.0% reflecting from new patient accruals. The global market share of Fabrazyme in value was 56% in the second quarter. First-half sales of Fabrazyme grew 28.4% to 221 million.
Sales of Myozyme /Lumizyme were 133 million in the second quarter, up 10.3%, driven by Emerging Markets (up 40.0% to 26 million). In the U.S. and Western Europe, sales were 33 million (up 13.3%) and 67 million (down 2.9%), respectively. First-half sales of Myozyme /Lumizyme increased 9.1% to 254 million.
Second-quarter sales of Aubagio were 97 million versus 33 million in the second quarter of 2013. In the U.S., sales of Aubagio reached 72 million versus 33 million in the second quarter of 2013. In Western Europe, where the launch of the product started in the fourth quarter of 2013, sales reached 21 million in the second quarter. The product is mainly commercially available in Germany, Switzerland, Nordic countries, Canada, Argentina and Australia. First-half sales of Aubagio were 175 million, up 245.3%.
Following its approval by the European Commission in September, Lemtrada is currently commercially available in a number of countries such as Germany, Nordic countries and Canada with additional launches expected in the second half of 2014. Second quarter and first-half sales of Lemtrada were 6 million and 11 million, respectively. In May, the U.S. Food and Drug Administration (FDA) accepted for review the resubmission of the supplemental Biologics License Application (sBLA) seeking approval of Lemtrada . A six-month review period has been assigned for the Lemtrada sBLA.
Other Innovative Products(8)
million Q2 2014 net sales Change (CER) H1 2014 net sales Change (CER)
Multaq 66 +0.0 % 139 +9.9 %
Jevtana 66 +25.9 % 132 +28.3 %
Mozobil 26 +4.0 % 51 +2.0 %
Zaltrap 15 +14.3 % 31 +28.0 %
Auvi-Q 16 +54.5 % 26 +42.1 %
Total Other Innovative Products 189 +13.3 % 379 +17.8 %
Other Innovative Products grew 13.3% to 189 million in the second quarter and 17.8% to 379 million in the first half, primarily driven by recent launches of Jevtana , Zaltrap and Auvi-Q .
Jevtana sales grew 25.9% to 66 million in the second quarter driven by launches in Western Europe ( 34 million, up 36.0%) and Emerging Markets ( 10 million, up 57.1%). First-half sales of Jevtana grew 28.3% to 132 million.
In the second quarter, sales of Zaltrap reached 15 million, an increase of 14.3% driven by recent launches in Western Europe ( 9 million versus 3 million in Q2 2013) which offset lower sales in the U.S.
Second-quarter sales of Auvi-Q , which was launched in the U.S. in January 2013, were 16 million (up 54.5%). First-half sales of the product were 26 million (+42.1%).
Other Pharmaceutical Products
million Q2 2014 net sales Change (CER) H1 2014 net sales Change (CER)
Plavix 425 -8.3 % 912 +4.3 %
Lovenox 421 +0.5 % 837 +0.9 %
Aprovel /Avapro 193 -15.5 % 372 -19.2 %
Renvela /Renagel 137 -18.3 % 309 -6.6 %
Synvisc /Sy nvisc-One 93 -6.7 % 163 -6.0 %
Myslee /Ambien /Stilnox 73 -15.2 % 151 -15.0 %
Taxotere 67 -36.8 % 136 -32.9 %
Eloxatin 47 -15.0 % 93 -15.1 %
Allegra 39 -46.8 % 119 -46.4 %
Second-quarter sales of Plavix were 425 million, down 8.3% reflecting anticipation in Japan in the first quarter of 2014 of an increase in the consumption tax which occurred in the second quarter. In Japan, sales were down 18.0% to 143 million in the second quarter of 2014 and up 48.5% in the first quarter of 2014 to 215 million. In Emerging Markets, sales grew 7.8% to 222 million driven by China where sales grew 15.9% to 124 million. First-half sales of Plavix increased 4.3% to 912 million.
Sales of Lovenox increased 0.5% to 421 million in the second quarter driven by Emerging Markets where sales increased 9.5% to 148 million. In Western Europe, sales of the product grew 2.8% to 222 million.
First-half sales of Lovenox were 837 million, an increase of 0.9%.
Sales of Aprovel /Avapro were 193 million in the second quarter, down 15.5%, reflecting generic competition in Western Europe where sales decreased 44.7% to 52 million. In Emerging Markets, sales of Aprovel /Avapro grew 3.7% to 106 million. First-half sales of Aprovel /Avapro totaled 372 million, down 19.2%.
Renvela /Renagel generated sales of 137 million in the second quarter, down 18.3%. In the U.S., sales of the product decreased 19.1% to 88 million reflecting the impact of the agreement with Impax which was granted a license to sell a limited allotment of bottles of an authorized generic version of Renvela tablets in the U.S. starting from April 2014. The specific allotment corresponds to 7-10% of the total 2013 sevelamer sales in the U.S. Sales of Renvela /Renagel in Western Europe and in Emerging Markets were 33 million (down 8.3%) and 11 million (down 31.6%), respectively. First-half sales of Renvela /Renagel totaled 309 million, a decrease of 6.6%.
(8) Includes new product launches which do not belong to the other Growth Platforms
In the second quarter, sales of Allegra as a prescription drug were 39 million, down 46.8% (excluding the change of category, sales decreased 16.0%) and sales of the Ambien family of products were 73 million, down 15.2%, reflecting generic competition in Japan for both products. First-half sales of Allegra and the Ambien family of products were 119 million and 151 million, respectively.
Second-quarter and first half sales of Taxotere decreased 36.8% ( 67 million) and 32.9% ( 136 million), respectively, reflecting generic erosion. Second-quarter and first half sales of Eloxatin decreased 15.0% ( 47 million) and 15.1% ( 93 million), respectively.
In the second quarter, sales of Generics totaled 466 million reflecting the recovery in Brazil where sales were 71 million. Second-quarter sales of Generics decreased 5.6% in Western Europe and 24.5% in the U.S. due to lower sales of the authorized generics of Lovenox . In Emerging Markets, sales of Generics reached 284 million, growing at 7.4% excluding Brazil. First-half sales of Generics increased 32.0% to 887 million.
million Q2 2014 net sales Change (CER) H1 2014 net sales Change (CER)
Polio/Pertussis/Hib Vaccines (incl. Pentacel , Pentaxim and Imovax ) 284 +2.0 % 495 -6.6 %
Influenza Vaccines (incl. Vaxigrip and Fluzone ) 59 +18.9 % 194 +19.2 %
Meningitis/Pneumonia Vaccines (incl. Menactra ) 115 -1.6 % 171 -10.8 %
Travel and Other Endemic Vaccines 103 +11.2 % 178 +11.0 %
Adult Booster Vaccines (incl. Adacel ) 83 -29.8 % 164 -17.7 %
Other Vaccines 74 +13.0 % 144 +8.7 %
Total Vaccines (consolidated sales) 718 -0.4 % 1,346 -2.2 %
Second-quarter consolidated sales of Sanofi Pasteur reached 718 million (down 0.4%) reflecting continued gradual recovery of Pentacel , strong performance of Flu vaccines and Travel and Other Endemic vaccines which was offset by lower Booster vaccines sales. First-half consolidated sales of Sanofi Pasteur were 1,346 million, (down 2.2%).
Sales of Polio/Pertussis/Hib vaccines increased 2.0% to 284 million, driven by the continued gradual recovery of Pentacel in the U.S. and the performance of Pentaxim in Emerging Markets which offset lower sales of inactivated Polio vaccines due to unfavorable phasing effect. First-half sales of Polio/Pertussis/Hib vaccines were 495 million, down 6.6%.
Sales of Influenza vaccines increased 18.9% to 59 million due to record influenza vaccines sales for the Southern Hemisphere in Emerging Markets. First-half sales of influenza vaccines increased 19.2% to 194 million. Sanofi Pasteur began shipping seasonal influenza vaccine in the U.S. on July 22, 2014 and it plans to distribute at least 65 million doses to help protect people across multiple age groups against the virus in the 2014-2015 season.
Second-quarter sales of Menactra increased 11.0% to 105 million, driven by the U.S. (+23.4%) and partially offset by lower sales in Saudi Arabia. First-half sales of Menactra were 153 million (down 3.0%).
Second-quarter sales of Travel and Other Endemic vaccines increased 11.2% to 103 million driven by higher sales of Typhim Vi and Yellow fever vaccines. First-half sales of travel and other endemic vaccines increased 11.0% to 178 million.
Adult Booster vaccines sales were 83 million in the second quarter, down 29.8%, still impacted by supply limitation in the U.S. First-half sales of Adult booster vaccines were 164 million (down 17.7%).
Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe, reported sales of 155 million, a decrease of 3.1% on a reported basis reflecting lower sales of booster vaccines and Gardasil . First-half sales of Sanofi Pasteur MSD were 313 million, down 6.1% on a reported basis.
million Q2 2014 net sales Change (CER) H1 2014 net sales Change (CER)
Companion Animal 345 +10.8 % 689 +3.0 %
Production Animal 192 -1.0 % 365 +0.8 %
Total Animal Health 537 +6.2 % 1,054 +2.2 %
of which fipronil products 169 +4.2 % 340 -2.5 %
of which NexGard 35 58
of which avermectin products 98 0.0 % 212 -8.6 %
of which Vaccines 180 -3.6 % 334 -2.5 %
Second-quarter sales of Animal Health increased 6.2% to 537 million driven by the launch of NexGard . In the U.S., Animal Health sales recorded strong growth (up 14.0% to 232 million). First-half sales of Animal Health increased 2.2% to 1,054 million.
Second-quarter sales of the Companion Animals segment grew 10.8% to 345 million, reflecting the success of the NexGard launch and resilience of the anti-parasiticide Frontline /fipronil family of products. Merial launched NexGard , our next generation flea and tick product for dogs in the first quarter in the U.S. and in several European countries during the first half of 2014. Second-quarter sales of NexGard reached 35 million of which 31 million was generated in the U.S. First-half sales of the Companion Animals segment increased 3.0% to 689 million.
Second-quarter sales and first-half sales of the Production Animals segment were 192 million (down 1.0%) and 365 million (up 0.8%), respectively.
Net sales by geographic region
million Q2 2014 net sales Change (CER) H1 2014 net sales Change (CER)
Emerging Markets(a) 2,855 +16.5 % 5,445 +11.0 %
of which Latin America 884 +55.3 % 1,618 +32.3 %
of which Asia 785 +6.7 % 1,519 +5.4 %
of which Eastern Europe, Russia and Turkey 635 +5.4 % 1,239 +4.7 %
of which Africa 253 +7.2 % 486 -2.4 %
of which Middle East 267 -7.0 % 520 +0.9 %
United States 2,569 +9.4 % 4,984 +8.5 %
Western Europe(b) 1,908 -2.8 % 3,906 -1.5 %
Rest of the world(c) 743 -11.2 % 1,582 -7.4 %
of which Japan 475 -13.5 % 1,062 -7.6 %
TOTAL 8,075 +6.4 % 15,917 +4.9 %
(a) World less the U.S., Canada, Western Europe, Japan, 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, Canada, Australia and New Zealand
Second-quarter sales in Emerging Markets increased 16.5% to 2,855 million. Excluding generics in Brazil, sales grew 8.6%. Double-digit growth was recorded for Diabetes (up 18.7%), Genzyme (up 47.3%) and CHC. Sales in China grew 13.4% to 401 million driven by Plavix , Lantus and Lovenox . Sales in Eastern Europe/Russia and Turkey increased 5.4%, supported by good performance of Turkey. Sales in Russia grew 8.8% to 215 million. In the Middle-East, sales decreased 7.0% to 267 million, reflecting lower sales in Iraq due to the difficult environment and decreased sales of Menactra in Saudi Arabia. In Brazil, sales increased 182.5% to 387 million (excluding generics, sales grew 29.0% driven by CHC). First-half sales in Emerging Markets increased 11.0% to 5,445 million. Excluding Brazil generics, sales grew 6.5%.
Second-quarter sales in the U.S. were strong (up 9.4% to 2,569 million), driven by Diabetes (up 20.3%), Genzyme (up 27.3%), CHC (up 23.2%) and Animal Health (up 14.0%). First-half sales in the U.S. totaled 4,984 million, up 8.5%.
Sales in Western Europe were 1,908 million in the second quarter, a decrease of 2.8%. Strong performance of Genzyme (+22.9%) was offset by the impact of generic competition to Aprovel as well as lower sales of vaccines. First-half sales in Western Europe totaled 3,906 million (down 1.5%).
Sales in Japan totaled 475 million, a decrease of 13.5%, reflecting lower sales of Plavix following a strong first quarter due to anticipation of an increase in the consumption tax which occurred in the second quarter. The impact of generic competition to Allegra , Myslee and Amaryl was partially offset by a strong performance in vaccines. First-half sales in Japan were 1,062 million (down 7.6%).
Consult Appendix 7 for full overview of Sanofi s R&D pipeline
Regulatory updates since the publication of the first-quarter 2014 results on April 29, 2014 include the following:
In July, the U.S. Food and Drug Administration (FDA) accepted for review the company s New Drug Application (NDA) for Toujeo , an investigational basal insulin. This follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries in May 2014. In July, the NDA for Toujeo was submitted to the Japanese Health Authorities (PMDA).
In July, the Japanese Health Authority (PMDA) granted a marketing authorization for Jevtana for the treatment of prostate cancer.
In June, Genzyme submitted a new drug application in Japan for its oral Gaucher s disease treatment, Cerdelga (eliglustat tartrate).
In May, Sanofi Pasteur s pediatric pentavalent vaccine Shan5 , developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad, India, received prequalification status from the World Health Organization (WHO).
In May, the U.S. Food and Drug Administration (FDA) accepted for review Genzyme s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period was assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter.
At the end of July 2014, the R&D pipeline contained 46 projects (excluding Life Cycle Management) and vaccine candidates in clinical development of which 12 are in Phase III or have been submitted to the health authorities for approval.
Sanofi and Regeneron announced on July 30, 2014, that nine new Phase III ODYSSEY trials of alirocumab in people with hypercholesterolemia met their primary efficacy endpoint of a greater percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at 24 weeks compared to placebo or active comparator. Alirocumab is an investigational monoclonal antibody targeting PCSK9. In the nine ODYSSEY trials, the mean percent reduction in LDL-C from baseline at 24 weeks in alirocumab-treated patients was consistent with results seen in previous alirocumab trials.
In July, the detailed results from the first landmark Phase III dengue vaccine efficacy study conducted in five countries in Asia were published in The Lancet. Results show overall efficacy against symptomatic dengue of 56.5% in children aged 2 to 14 years old after a three-dose vaccination schedule. Importantly, analyses show an 88.5% reduction of dengue haemorrhagic fever, the severe form of dengue, according
Last updated: Jul 31, 2014