Form 6-K Sanofi For: Oct 28
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.� 20549
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FORM�6-K
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REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
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For the month of October�2014
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Commission File Number: 001-31368
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SANOFI
(Translation of registrant�s name into English)
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54, rue La Bo�tie, 75008 Paris, FRANCE
(Address of principal executive offices)
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Indicate by check mark whether the registrant files or will file annual reports under cover Form�20-F or Form�40-F.
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Form�20-F x |
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Form�40-F o |
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Indicate by check mark if the registrant is submitting the Form�6-K in paper as permitted by Regulation S-T Rule�101(b)(1): o
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Indicate by check mark if the registrant is submitting the Form�6-K in paper as permitted by Regulation S-T Rule�101(b)(7): o
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Indicate by check mark whether the registrant by furnishing the information contained in this Form�is also thereby furnishing the information to the Commission pursuant to Rule�12g3-2(b)�under the Securities Exchange Act of 1934.
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Yes o |
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No x |
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If �Yes� marked, indicate below the file number assigned to the registrant in connection with Rule�12g3-2(b):� 82-
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In September�and October�2014, Sanofi issued the statements attached hereto as Exhibits 99.1 to 99.8 which are incorporated herein by reference.
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Exhibit�List
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Exhibit�No. |
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Description |
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Exhibit�99.1 |
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Press release dated October�28, 2014: Third Quarter 2014 Results |
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Exhibit�99.2 |
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Press release dated October�20, 2014: Sanofi and Regeneron Announce Start of Phase 3 Study of Dupilumab in Patients with Atopic Dermatitis |
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Exhibit�99.3 |
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Press release dated October�16, 2014: Sanofi Pasteur and Immune Design Collaborate on a Vaccine to Treat Herpes Simplex Virus |
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Exhibit�99.4 |
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Press release dated October�14, 2014: Shantha�s Investigational Rotavirus Vaccine Enters Phase III Clinical Trials in India |
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Exhibit�99.5 |
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Press release dated September�30, 2014: Sanofi and Regeneron Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps |
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Exhibit�99.6 |
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Press release dated September�17, 2014: Sanofi and MyoKardia Announce Groundbreaking Collaboration to Develop Targeted Therapies for Patients with Genetic Heart Disease |
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Exhibit�99.7 |
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Press release dated September�11, 2014: At Four Years, Treatment Effect Maintained in More Than Two-Thirds of Patients Who Received Genzyme�s Lemtrada in Pivotal Studies |
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Exhibit�99.8 |
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Genzyme Product Sales Statement, for the Product Sales Measuring Period ended September�30, 2014 |
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SIGNATURES
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Dated: October�28, 2014 |
SANOFI | ||
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By |
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/S/ John Felitti |
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Name: |
John Felitti |
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Title: |
Associate Vice President, |
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Corporate Law, Financial�& Securities Law |
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Exhibit�Index
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Exhibit�No. |
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Description |
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Exhibit�99.1 |
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Press release dated October�28, 2014: Third Quarter 2014 Results |
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Exhibit�99.2 |
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Press release dated October�20, 2014: Sanofi and Regeneron Announce Start of Phase 3 Study of Dupilumab in Patients with Atopic Dermatitis |
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Exhibit�99.3 |
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Press release dated October�16, 2014: Sanofi Pasteur and Immune Design Collaborate on a Vaccine to Treat Herpes Simplex Virus |
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Exhibit�99.4 |
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Press release dated October�14, 2014: Shantha�s Investigational Rotavirus Vaccine Enters Phase III Clinical Trials in India |
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Exhibit�99.5 |
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Press release dated September�30, 2014: Sanofi and Regeneron Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps |
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Exhibit�99.6 |
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Press release dated September�17, 2014: Sanofi and MyoKardia Announce Groundbreaking Collaboration to Develop Targeted Therapies for Patients with Genetic Heart Disease |
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Exhibit�99.7 |
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Press release dated September�11, 2014: At Four Years, Treatment Effect Maintained in More Than Two-Thirds of Patients Who Received Genzyme�s Lemtrada in Pivotal Studies |
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Exhibit�99.8 |
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Genzyme Product Sales Statement, for the Product Sales Measuring Period ended September�30, 2014 |
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Exhibit�99.1
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PRESS RELEASE
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Paris, October�28, 2014 |
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Sanofi delivers Business EPS(1)�growth of 10.3% at CER in Q3 2014
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Solid sales and business EPS(1)�growth at CER in the third quarter
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��������� Group sales(2)�up 5.1% to �8,781 million
��������� Growth platforms(3)�increased 10.0% to �6,862 million, representing 78.1% of total sales
��������� Business net income(1)�grew 9.4% at CER to �1,935 million (+7.8% on a reported basis)
��������� Business EPS(1)�increased 10.3% at CER to �1.47
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Steady sales increase in growth platforms
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��������� Diabetes grew 8.3% to �1,799 million despite increased price competition in the U.S.
��������� Vaccines sales grew 11.2% driven by strong performance of flu vaccine and progressive supply recovery
��������� Genzyme continued to deliver with sales growth of 24.6%
��������� Animal Health grew 12.7% due to strong sales in the U.S. market
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Significant advances in bringing new medicines to market
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��������� Cerdelga�, the only oral therapy for adult Gaucher disease type 1 patients, approved in the U.S.
��������� Detailed results from four pivotal Phase III alirocumab trials presented at the ESC congress
��������� Final landmark Phase III efficacy study in Latin America for Dengue vaccine successfully completed
��������� Dupilumab, an investigational therapy for moderate-to-severe atopic dermatitis, entered Phase III
��������� Investigational rotavirus vaccine for Emerging Markets entered Phase III
��������� Global licensing agreement announced for Afrezza�, a new rapid-acting inhaled insulin
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Financial guidance for 2014 confirmed
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��������� 2014 business EPS(1)�is expected to be between 6% to 8% higher than 2013 at CER, barring major unforeseen adverse events
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Sanofi Chief Executive Officer, Christopher A. Viehbacher commented:
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�We are pleased with our performance in the third quarter. We achieved solid Business EPS growth driven by continued strong contribution from our growth platforms, allowing us to confirm 2014 outlook. Growth platforms reached over 78% of sales and grew 10%. We have recently seen a more challenging U.S. diabetes price environment which will impact our diabetes sales throughout 2015, while growth platforms globally are expected to continue to show solid growth. At the same time, our pipeline delivered strong results, with the release of exciting Phase III data for alirocumab and our Dengue vaccine, the entry of dupilumab in Phase III as well as the FDA approval of Cerdelga� and the licensing of Afrezza�.�
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(1)�See Appendix 8 for definitions of financial indicators; (2)�Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8 for a definition); (3)�See page�2
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Investor Relations: (+) 33 1 53 77 45 45 - E-mail: [email protected] �- �Media Relations: (+) 33 1 53 77 46 46 - E-mail: [email protected]
Web site: www.sanofi.com� Mobile app�: SANOFI IR available on the App Store and Google Play
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2014 third-quarter and 9-month figures
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� |
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Q3�2014 |
� |
Change |
� |
Change |
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9M�2014 |
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Change |
� |
Change |
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Net sales |
� |
� |
8,781 |
m |
+4.1 |
% |
+5.1 |
% |
� |
24,698 |
m |
+0.8 |
% |
+5.0 |
% |
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� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� | ||
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Business net income(1) |
� |
� |
1,935 |
m |
+7.8 |
% |
+9.4 |
% |
� |
5,019 |
m |
+3.0 |
% |
+9.3 |
% |
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� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
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Business EPS(1) |
� |
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1.47 |
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+8.1 |
% |
+10.3 |
% |
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3.81 |
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+3.5 |
% |
+10.1 |
% |
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In order to facilitate an understanding of 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 9M 2014 is provided in Appendix 4 and a reconciliation of business net income to consolidated net income in Appendix 3. Consolidated net income for 9M 2014 was �3,051 million compared to �2,656 million for 9M 2013. Consolidated EPS for 9M 2014 was �2.32 versus �2.01 for 9M 2013. Consolidated EPS for Q3 2014 was �0.91 versus �0.92 for Q3 2013.
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2014 third-quarter and 9-month sales
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Unless otherwise indicated, all sales growth figures in this press release are stated at constant exchange rates(1).
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In the third quarter of 2014, Sanofi generated sales of �8,781 million, an increase of 4.1% on a reported basis. Exchange rate movements had a negative effect of 1.0 percentage point primarily reflecting the strength of the euro versus other currencies, in particular the Argentine Peso, Japanese Yen and Russian Ruble.
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Year-to-date sales increased 0.8% to �24,698 million on a reported basis. Exchange rate movements had an unfavorable effect of 4.2 percentage points.
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Growth Platforms
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In the third quarter, sales of the Group�s growth platforms increased 10.0% to �6,862 million, driven by the performance of Genzyme (up 24.6%), Vaccines (up 11.2%), Animal Health (up 12.7%) and Other Innovative Products (up 18.0%). The Group�s growth platforms accounted for 78.1% of total consolidated sales in the third quarter, up from 74.7% in the third quarter of 2013. Year-to-date sales of growth platforms reached �18,801 million, an increase of 10.8%, and accounted for 76.1% of total consolidated sales compared with 72.5% in the first nine month of 2013.
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� million |
� |
Q3�2014 |
� |
Change |
� |
9M�2014 |
� |
Change |
� |
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Diabetes |
� |
1,799 |
� |
+8.3 |
% |
5,249 |
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+12.5 |
% |
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Vaccines |
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1,451 |
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+11.2 |
% |
2,797 |
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+4.1 |
% |
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Consumer Healthcare (CHC) |
� |
819 |
� |
+12.9 |
% |
2,520 |
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+17,3 |
% |
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Genzyme |
� |
649 |
� |
+24.6 |
% |
1,858 |
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+25.1 |
% |
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Animal Health |
� |
515 |
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+12.7 |
% |
1,569 |
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+5.3 |
% |
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Other Innovative Products(a) |
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227 |
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+18.0 |
% |
606 |
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+17.9 |
% |
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Emerging Markets(b) |
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2,776 |
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+7.6 |
% |
8,221 |
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+9.9 |
%(c) |
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of which Diabetes, Vaccines, CHC, Animal Health, Genzyme and Other Innovative Products |
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1,374 |
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+14.0 |
% |
4,019 |
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+14.8 |
% |
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of which other products |
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1,402 |
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+2.0 |
% |
4,202 |
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+5.5 |
% |
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Total Growth Platforms |
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6,862 |
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+10.0 |
% |
18,801 |
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+10.8 |
% |
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(a)�������� Includes product launches since 2009 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 6.1% in 9M 2014.
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(1)�See Appendix 8 for definitions of financial indicators.
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Pharmaceuticals
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Third-quarter sales for the Pharmaceuticals business grew 3.4% to �6,815 million, driven by Emerging Markets. Year-to-date sales for Pharmaceuticals increased 5.1% to �20,332 million.
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Diabetes
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� million |
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Q3�2014 |
� |
Change |
� |
9M�2014 |
� |
Change |
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Lantus� |
� |
1,567 |
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+8.1 |
% |
4,572 |
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+12.5 |
% |
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Amaryl� |
� |
87 |
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-2.2 |
% |
269 |
� |
+0.7 |
% |
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Apidra� |
� |
88 |
� |
+21.9 |
% |
240 |
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+20.3 |
% |
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Insuman� |
� |
34 |
� |
0.0 |
% |
99 |
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+3.0 |
% |
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BGM (Blood Glucose Monitoring) |
� |
14 |
� |
+25.0 |
% |
46 |
� |
+34.3 |
% |
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Lyxumia� |
� |
8 |
� |
� |
� |
19 |
� |
� |
� |
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Total Diabetes |
� |
1,799 |
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+8.3 |
% |
5,249 |
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+12.5 |
% |
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Third-quarter sales of the Diabetes division reached �1,799 million, an increase of 8.3%. Year-to-date sales of the Diabetes division increased 12.5% to �5,249 million. Lantus��sales increased 8.1% to �1,567 million in the third quarter. In the U.S., third-quarter sales of Lantus��reached �1,042 million, an increase of 5.8%, reflecting increasing competitive pressure at the payor level. Lantus��SoloSTAR��represented 62.2% of total Lantus��sales, versus 57.4% for the same period in 2013. In Emerging Markets, Lantus��sales grew 19.7% to �232�million in the third quarter, reflecting good performance in China, Turkey, Middle East, Mexico and Africa. In Western Europe, sales of Lantus��recorded a strong performance with sales up 9.5% to �222 million driven by Germany, France and Italy. Year-to-date sales of Lantus��reached �4,572 million, up 12.5%.
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Sanofi has recently concluded payor negotiations in the U.S.�and has secured favorable formulary positions for Lantus��with key payors. The level of rebates required to maintain these positions has increased significantly due to aggressive discounting by competitors. The rebates will not change the Group�s Business EPS guidance for 2014. The increased rebates in the U.S. and the impact of the Affordable Care Act will continue in 2015. Sanofi expects to mitigate this impact on the Diabetes division in 2015 through the launches of Toujeo��and Afrezza��as well as continued strong growth in Emerging Markets. Therefore, global sales of the Diabetes division are expected to be broadly stable in 2015.
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Third-quarter sales of Amaryl��were �87 million, down 2.2%. In Emerging Markets, Amaryl��sales increased 6.2% to �68 million. Year-to-date sales of Amaryl��were �269 million (up 0.7%).
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Apidra��sales increased 21.9% to �88 million. The product recorded strong growth in all territories. In the U.S., sales were up 20.7% to �35 million. In Emerging Markets, sales were up 25.0% to �19 million and in Western Europe, sales grew 19.0% to �26 million. Year-to-date sales of Apidra��grew 20.3% to �240 million.
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Third-quarter and year-to-date sales of Lyxumia��were �8 million and �19 million, respectively.
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In August, Sanofi and MannKind entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza�, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. The companies plan to launch Afrezza��in the United States in the first quarter of 2015. Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities.
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Consumer Healthcare
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� million |
� |
Q3�2014 |
� |
Change |
� |
9M�2014 |
� |
Change |
� |
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Allegra� |
� |
78 |
� |
+31.7 |
% |
276 |
� |
+30.4 |
% |
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Doliprane� |
� |
74 |
� |
+4.2 |
% |
232 |
� |
+5.4 |
% |
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Essentiale� |
� |
53 |
� |
+46.2 |
% |
174 |
� |
+32.0 |
% |
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Enterogermina� |
� |
48 |
� |
+53.1 |
% |
122 |
� |
+28.0 |
% |
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No Spa� |
� |
31 |
� |
+6.3 |
% |
84 |
� |
+9.3 |
% |
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Lactacyd� |
� |
24 |
� |
-3.7 |
% |
81 |
� |
+15.4 |
% |
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Nasacort� |
� |
23 |
� |
� |
� |
91 |
� |
� |
� |
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Maalox� |
� |
23 |
� |
+9.5 |
% |
73 |
� |
+11.6 |
% |
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Dorflex� |
� |
18 |
� |
-25.0 |
% |
68 |
� |
+10.0 |
% |
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Other CHC Products |
� |
447 |
� |
+4.1 |
% |
1,319 |
� |
+8.6 |
% |
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Total Consumer Healthcare |
� |
819 |
� |
+12.9 |
% |
2,520 |
� |
+17.3 |
% |
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Sales of Consumer Healthcare products (CHC) were �819 million in the third quarter, an increase of 12.9%. Several products (amounting to �64 million in sales) previously recorded in prescription pharmaceuticals in the third quarter of 2013 were transferred to Consumer Healthcare products. Excluding this category change, sales of CHC grew 4.0% driven by the success of the Nasacort��Rx-to-OTC switch in the U.S. and good performance in Emerging Markets (+7.8%). Sales of Nasacort� Allergy 24HR nasal spray, which has been available over-the-counter (OTC) in the U.S. since February, were �18 million in the third quarter in the U.S.
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Year-to-date sales of CHC were �2,520 million, an increase of 17.3%. Excluding the category change mentioned above (�205 million in the first nine month of 2013), CHC sales grew 7.6%.
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Genzyme
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� million |
� |
Q3�2014 |
� |
Change |
� |
9M�2014 |
� |
Change |
� |
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Cerezyme� |
� |
175 |
� |
+9.1 |
% |
518 |
� |
+8.3 |
% |
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Myozyme� / Lumizyme� |
� |
138 |
� |
+9.4 |
% |
392 |
� |
+9.2 |
% |
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Fabrazyme� |
� |
116 |
� |
+21.9 |
% |
337 |
� |
+26.2 |
% |
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Aldurazyme� |
� |
41 |
� |
+7.9 |
% |
127 |
� |
+13.8 |
% |
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Total Rare Diseases |
� |
530 |
� |
+10.9 |
% |
1,553 |
� |
+11.8 |
% |
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Aubagio� |
� |
112 |
� |
+156.8 |
% |
287 |
� |
+205.2 |
% |
|
Lemtrada� |
� |
7 |
� |
� |
� |
18 |
� |
� |
� |
|
Total Multiple Sclerosis |
� |
119 |
� |
+175.0 |
% |
305 |
� |
+224.7 |
% |
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Total Genzyme |
� |
649 |
� |
+24.6 |
% |
1,858 |
� |
+25.1 |
% |
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Sales of Genzyme increased 24.6% to �649 million in the third quarter driven by the growth of Aubagio� and Fabrazyme�. Sales grew 28.2% to �259 million in the U.S., 25.0% to �207 million in Western Europe and 19.8% to �124 million in Emerging Markets. Year-to-date sales of Genzyme reached �1,858 million, an� increase of 25.1%.
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Third quarter-sales of Cerezyme��grew 9.1% to �175 million, reflecting double digit-growth in Western Europe (up 15.4% to �60 million). Sales of Cerezyme��grew 7.0% to �56 million and 4.3% to �48 million in Emerging Markets and the U.S., respectively. Year-to-date sales of Cerezyme� grew 8.3% to �518 million. In August, the FDA approved Cerdelga�, the only first-line oral therapy for Gaucher disease type 1 patients (GD1). The vast majority of adult GD1 patients should be eligible for Cerdelga�, which is now available in the U.S.
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Fabrazyme��continued its strong performance with sales of �116 million, up 21.9% in the third quarter driven by Western Europe (up 40.0% to �28 million) and Emerging Markets (up 33.3% to �15 million). In the U.S., sales of Fabrazyme��reached �58 million, an increase of 14.0%. Year-to-date sales of Fabrazyme� grew 26.2% to �337 million.
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Third-quarter sales of Myozyme�/Lumizyme��increased 9.4% to �138 million, driven by Emerging Markets (up 42.1% to �25 million). In the U.S. and Western Europe, sales were �35 million (up 9.4%) and �69 million (up 1.5%), respectively. Year-to-date sales of Myozyme�/Lumizyme��grew 9.2% to �392 million.
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Third-quarter sales of Aubagio��reached �112 million versus �44 million in the third quarter of 2013. In the U.S., sales of Aubagio��were �87 million versus �44 million in the third quarter of 2013. In Western Europe, where the launch of the product started in the fourth quarter of 2013, sales reached �18 million in the third quarter. The product is mainly commercially available in the U.S., Germany, Switzerland, Nordic countries, Canada, Argentina and Australia. Year-to-date sales of Aubagio��totaled �287 million, up 205.2%.
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In October, the Food and Drug Administration (FDA) approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of Aubagio��in the product�s U.S. label. Aubagio��is the only oral treatment to significantly slow progression of disability in two Phase III studies of patients with relapsing multiple sclerosis (TEMSO and TOWER), and to have positive data on early multiple sclerosis in its label.
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Third quarter and year-to-date sales of Lemtrada� were �7 million and �18�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� for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada� sBLA.
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Other Innovative Products(4)
�
|
� million |
� |
Q3�2014 |
� |
Change |
� |
9M�2014 |
� |
Change |
� |
|
Multaq� |
� |
76 |
� |
+13.4 |
% |
215 |
� |
+11.1 |
% |
|
Jevtana� |
� |
67 |
� |
+15.3 |
% |
199 |
� |
+23.6 |
% |
|
Auvi-Q� |
� |
37 |
� |
+26.7 |
% |
63 |
� |
+32.7 |
% |
|
Mozobil� |
� |
29 |
� |
+20.0 |
% |
80 |
� |
+7.9 |
% |
|
Zaltrap� |
� |
18 |
� |
+30.8 |
% |
49 |
� |
+28.9 |
% |
|
Total Other Innovative Products |
� |
227 |
� |
+18.0 |
% |
606 |
� |
+17.9 |
% |
�
Other Innovative Products increased 18.0% to �227 million in the third quarter and 17.9% to �606 million in the first nine months.
�
Sales of Multaq��were �76 million, up 13.4% in the third quarter. Year-to-date sales of the product increased 11.1% to �215 million.
�
Third-quarter sales of Jevtana��increased 15.3% to �67 million driven by launches in Western Europe and Emerging Markets. Year-to-date sales of Jevtana��grew 23.6% to �199 million.
�
Third-quarter sales of Auvi-Q� were �37 million (up 26.7%). Year-to-date sales of the product were �63 million (up 32.7%).
�
In the third quarter, sales of Zaltrap��reached �18 million, an increase of 30.8% driven by recent launches in Western Europe which offset lower sales in the U.S. Year-to-date sales of the product were �49 million (up 28.9%).
�
Other Pharmaceutical Products
�
|
� million |
� |
Q3�2014 |
� |
Change |
� |
9M�2014 |
� |
Change |
� |
|
Plavix� |
� |
450 |
� |
+9.0 |
% |
1,362 |
� |
+5.8 |
% |
|
Lovenox� |
� |
426 |
� |
+7.2 |
% |
1,263 |
� |
+2.9 |
% |
|
Aprovel�/Avapro� |
� |
178 |
� |
-14.8 |
% |
550 |
� |
-17.9 |
% |
|
Renvela�/Renagel� |
� |
162 |
� |
-13.4 |
% |
471 |
� |
-9.0 |
% |
|
Synvisc� /Synvisc-One� |
� |
88 |
� |
-2.2 |
% |
251 |
� |
-4.8 |
% |
|
Myslee�/Ambien�/Stilnox� |
� |
78 |
� |
-16.0 |
% |
229 |
� |
-15.3 |
% |
|
Taxotere� |
� |
59 |
� |
-28.6 |
% |
195 |
� |
-31.7 |
% |
|
Eloxatin� |
� |
43 |
� |
-12.0 |
% |
136 |
� |
-14.2 |
% |
|
Allegra� |
� |
32 |
� |
-52.1 |
% |
151 |
� |
-47.6 |
% |
�
(4)�Includes new product launches which do not belong to the other Growth Platforms
�
�
Sales of Plavix��grew 9.0% to �450 million in the third quarter, driven by strong performance in Emerging Markets (up 21.3% to �203 million) and Japan (up 8.7% to �190 million). The performance of the product in Emerging Markets was driven by China where sales grew 47.1% to �125 million. Year-to-date sales of Plavix��increased 5.8% to �1,362 million.
�
Third-quarter sales of Lovenox��were up 7.2% to �426 million sustained by the strong performance in Emerging Markets where sales increased 16.9% to �147 million driven by China and Latin America. In Western Europe, sales of the product grew 5.8% to �221 million. Year-to-date sales of Lovenox��totaled �1,263 million, an increase of 2.9%.
�
Aprovel�/Avapro��generated sales of �178 million in the third quarter, down 14.8%, reflecting generic competition in Western Europe where sales decreased 47.4% to �41 million. In Emerging Markets, sales of Aprovel�/Avapro� increased 9.3% to �105 million driven by China. Year-to-date sales of Aprovel�/Avapro��were �550 million, down 17.9%.
�
Third-quarter sales of Renvela�/Renagel��were �162 million in the third quarter, down 13.4%. In the U.S., sales of the product decreased 22.0% to �103 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 up to 10% of the total 2013 sevelamer sales in the U.S. In Emerging Markets, sales of Renvela�/Renagel��increased 22.2% to �22 million. In Western Europe sales were stable at �32 million. Year-to-date sales of Renvela�/Renagel��were �471 million, a decrease of 9.0%.
�
In the third quarter, sales of Allegra��as a prescription drug were �32 million, down 52.1% (excluding the change of category, sales decreased 19.0%) and sales of the Ambien� family of products were �78 million, down 16.0%, reflecting generic competition in Japan for both products. Year-to-date sales of Allegra��and the Ambien��family of products were �151 million and �229 million, respectively.
�
Third-quarter and year-to-date sales of Taxotere� decreased 28.6% (�59 million) and 31.7% (�195 million), respectively, mainly due to generic erosion. Third-quarter and year-to-date sales of Eloxatin� decreased 12.0% (�43�million) and 14.2% (�136 million), respectively.
�
Generics
�
Third-quarter sales of Generics increased 8.3% to �451 million reflecting the recovery in Brazil where sales were �76 million. Third-quarter sales of Generics decreased 3.9% in Western Europe (to �125 million) and 24.3% in the U.S. (to �28 million). In Emerging Markets, sales of Generics grew 19.8% to �287 million driven by the recovery in Brazil. Year-to-date sales of Generics increased 23.2% to �1,338 million.
�
Vaccines
�
|
� million |
� |
Q3�2014 |
� |
Change |
� |
9M�2014 |
� |
Change |
� |
|
Polio/Pertussis/Hib Vaccines |
� |
259 |
� |
+7.4 |
% |
754 |
� |
-2.4 |
% |
|
Influenza Vaccines |
� |
650 |
� |
+15.0 |
% |
844 |
� |
+16.0 |
% |
|
Meningitis/Pneumonia Vaccines |
� |
191 |
� |
-10.0 |
% |
362 |
� |
-10.4 |
% |
|
Adult Booster Vaccines |
� |
131 |
� |
+54.8 |
% |
295 |
� |
+3.1 |
% |
|
Travel and Other Endemic Vaccines |
� |
99 |
� |
-3.0 |
% |
277 |
� |
+5.9 |
% |
|
Other Vaccines |
� |
121 |
� |
+21.8 |
% |
265 |
� |
+14.2 |
% |
|
Total Vaccines (consolidated sales) |
� |
1,451 |
� |
+11.2 |
% |
2,797 |
� |
+4.1 |
% |
�
Third-quarter consolidated sales of Sanofi Pasteur increased 11.2% to �1,451 million driven by strong performance of influenza vaccines in the U.S. and in Emerging Markets as well as continued gradual recovery of Pentacel��and Adacel��in the U.S. Year-to-date consolidated sales of Sanofi Pasteur increased 4.1% to �2,797 million.
�
�
Third-quarter sales of Influenza vaccines grew 15.0% to �650 million due to strong influenza vaccines sales in the U.S. and in Emerging Markets. In the U.S., Sanofi Pasteur�s strategy to offer differentiating vaccines leads to a strong uptake of Fluzone��High-Dose for elderly people and Fluzone��Quadrivalent vaccine, a four-strain influenza vaccine. Year-to-date sales of influenza vaccines increased 16.0% to �844�million.
�
Sales of Polio/Pertussis/Hib vaccines increased 7.4% to �259 million in the third quarter. In the U.S., Polio/Pertussis/Hib vaccines sales were �97 million, an increase of 94.0% sustained by the continued gradual recovery of Pentacel�. In Emerging Markets sales of Polio/Pertussis/Hib vaccines decreased 20.6% to �120 million reflecting lower sales of Pentaxim��and Polio vaccines in Asia. Year-to-date sales of Polio/Pertussis/Hib vaccines were �754 million, down 2.4%.
�
Third-quarter sales of Menactra��were �174 million, down 10.3%. In the U.S., lower sales of Menactra��reflected phasing of public orders while strong market share was maintained. Year-to-date sales of Menactra��were �327 million down 6.9%.
�
Sales of Travel and Other Endemic vaccines were down 3.0% to �99 million and up 5.9% to �277 million in the third quarter and the first nine months of 2014, respectively.
�
Third-quarter sales of Adult Booster vaccines increased 54.8% to �131 million, reflecting supply improvement and positive phasing of Adacel��sales. Year-to-date sales of Adult booster vaccines were �295 million, an increase of 3.1%.
�
Sanofi Pasteur MSD (not consolidated), the joint venture with Merck�& Co. in Europe, reported stable sales at �295�million. Increased sales of Zostavax� were offset by lower sales of Gardasil�. Year-to-date sales of Sanofi Pasteur MSD were �608 million, down 3.4% on a reported basis.
�
Animal Health
�
|
� million |
� |
Q3�2014 |
� |
Change |
� |
9M�2014 |
� |
Change |
� |
|
Companion Animal |
� |
317 |
� |
+13.3 |
% |
1,006 |
� |
+5.9 |
% |
|
Production Animal |
� |
198 |
� |
+11.7 |
% |
563 |
� |
+4.2 |
% |
|
Total Animal Health |
� |
515 |
� |
+12.7 |
% |
1,569 |
� |
+5.3 |
% |
|
of which fipronil products |
� |
143 |
� |
-5.3 |
% |
483 |
� |
-3.3 |
% |
|
of which NexGard� |
� |
27 |
� |
� |
� |
85 |
� |
� |
� |
|
of which avermectin products |
� |
101 |
� |
+11.1 |
% |
313 |
� |
-3.3 |
% |
|
of which Vaccines |
� |
176 |
� |
+11.3 |
% |
510 |
� |
+1.7 |
% |
�
Third-quarter sales of Animal Health increased 12.7% to �515 million driven by the launch of NexGard� and the strong performance of the production animal segment. In the U.S., Animal Health sales grew 23.2% to �220 million. Year-to-date sales of Animal Health increased 5.3% to �1,569 million.
�
Third-quarter sales of the Companion Animals segment increased 13.3% to �317 million, reflecting the NexGard� launch as well as performance of pet vaccines and Heartgard�. Merial launched, its next generation flea and tick product for dogs, NexGard�, in the U.S. in the first quarter and in several European countries during the first nine months of the year. Third-quarter sales of NexGard� reached �27 million of which �23 million was generated in the U.S. Sales of the Companion Animals segment increased 19.5% in the U.S. to �185 million. Year-to-date sales of the Companion Animals segment increased 5.9% to �1,006�million.
�
Third-quarter sales of the Production Animals segment increased 11.7% to �198 million driven by double-digit growth of products for ruminants and swine. Furthermore, favorable phasing for tenders of Veterinary Public Health products had a positive impact in the quarter. Sales of the Production Animals segment increased 4.2% to �563 million year-to-date.
�
�
Net sales by geographic region
�
|
� million |
� |
Q3�2014 |
� |
Change |
� |
9M�2014 |
� |
Change |
� |
|
Emerging Markets(a) |
� |
2,776 |
� |
+7.6 |
% |
8,221 |
� |
+9.9 |
% |
|
of which Latin America |
� |
811 |
� |
+8.0 |
% |
2,429 |
� |
+23.7 |
% |
|
of which Asia |
� |
814 |
� |
+9.6 |
% |
2,333 |
� |
+6.8 |
% |
|
of which Eastern Europe, Russia and Turkey |
� |
629 |
� |
+4.8 |
% |
1,868 |
� |
+4.7 |
% |
|
of which Africa |
� |
257 |
� |
+13.9 |
% |
743 |
� |
+2.5 |
% |
|
of which Middle East |
� |
236 |
� |
+3.5 |
% |
756 |
� |
+1.7 |
% |
|
United States |
� |
3,208 |
� |
+7.2 |
% |
8,192 |
� |
+8.0 |
% |
|
Western Europe(b) |
� |
2,003 |
� |
+3.1 |
% |
5,909 |
� |
+0.0 |
% |
|
Rest of the world(c) |
� |
794 |
� |
-5.4 |
% |
2,376 |
� |
-6.8 |
% |
|
of which Japan |
� |
507 |
� |
-7.2 |
% |
1,569 |
� |
-7.4 |
% |
|
TOTAL |
� |
8,781 |
� |
+5.1 |
% |
24,698 |
� |
+5.0 |
% |
�
(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
�
In the third quarter, sales in Emerging Markets grew 7.6% to �2,776 million. Pharmaceuticals sales increased 9.2% driven by Diabetes (up 17.5%), Genzyme (up 19.8%), and Generics (up 19.8%). Sales in China grew 10.5% to �386 million reflecting strong performance of Pharmaceuticals (up 20.1%) partially offset by Vaccines notably due to lower sales of Pentaxim�. In China, the Pharmaceuticals sales growth was driven by Plavix�, Lantus��and Aprovel�. Sales in Eastern Europe, Russia and Turkey were up 4.8%, supported by good performance in Turkey and Hungary. Sales in Russia reached �195 million, an increase of 4.3%. In the Middle-East, sales grew 3.5% to �236 million. In Brazil, sales increased 17.5% to �318 million sustained by the performance of generics. Year-to-date sales in Emerging Markets increased 9.9% to �8,221 million. Excluding Brazil generics, sales in Emerging Markets grew 6.1%.
�
In the U.S., sales were up 7.2% to �3,208 million in the third quarter, due largely to strong performance of Genzyme (up 28.2%), Vaccines (up 15.8%) and Animal Health (up 23.2%). Year-to-date sales in the U.S. increased 8.0% to �8,192�million.
�
Western Europe returned to growth in the third-quarter with sales increasing 3.1% to �2,003 million. Strong performance of Genzyme (up 25.0%) was offset by the impact of generic competition to Aprovel�. Year-to-date sales in Western Europe were stable at �5,909 million.
�
Third-quarter sales in Japan were �507 million, a decrease of 7.2%, reflecting the impact of generic competition to Allegra�, Myslee�, Amaryl��and Taxotere��partially offset by the performance of Plavix��and Vaccines. Year-to-date sales in Japan were �1,569 million (down 7.4%).
�
R&D update
�
Consult Appendix 6 for full overview of Sanofi�s R&D pipeline
�
Regulatory update
�
Regulatory updates since the publication of the second-quarter 2014 results on July�31, 2014 include the following:
�
������������������ In August, the U.S. Food and Drug Administration (FDA) approved Cerdelga� (eliglustat) capsules, the only first-line oral therapy for certain adult Gaucher disease type 1 patients.
�
������������������ The sBLA for Lumizyme��label expansion and 4,000L manufacturing process was also approved in August�by the FDA. Lumizyme��is now indicated for all patients with Pompe disease regardless of age or phenotype.
�
�
������������������ In September, the BLA for a pediatric hexavalent vaccine PR5i (DTP-Hep B-Polio-Hib) was submitted in the U.S.
�
������������������ At the end of July, Sanofi and Regeneron announced that the companies intend to use a U.S. Food and Drug Administration rare pediatric disease priority review voucher in connection with the Biologics License Application (BLA) submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review. Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end.
�
At the end of October�2014, the R&D pipeline contained 46 projects (excluding Life Cycle Management) and vaccine candidates in clinical development of which 14 are in Phase III or have been submitted to the regulatory authorities for approval.
�
Portfolio update
�
Phase III:
�
������������������ In October, dupilumab, (an investigational monoclonal antibody that blocks IL-4 and IL-13 signaling, in collaboration with Regeneron), entered into Phase III in adults with moderate-to-severe atopic dermatitis that is not adequately controlled with topical atopic dermatitis medications.
�
������������������ In October, Sanofi Pasteur announced the start of a phase III clinical trial in India for its investigational rotavirus vaccine, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad,�India.
�
������������������ In September, positive interim results from the second year of the extension study of Lemtrada� (alemtuzumab) for multiple sclerosis were announced. In this analysis, relapse rates and sustained accumulation of disability remained low among patients who had previously received Lemtrada in either of the Phase III CARE-MS I and CARE-MS II studies. In these pivotal studies, Lemtrada� was given as two annual courses, at the start of the study and 12 months later. Approximately 70% of patients who received Lemtrada� in the pivotal studies did not receive further treatment with Lemtrada� through the second year of the extension study (corresponding to year 4). No new safety signals were identified.
�
������������������ In September, Sanofi Pasteur, announced that the final landmark phase III efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. Results showed an overall significant reduction of 60.8%* of dengue disease cases in children and adolescents 9-16 years old after a three-dose vaccination schedule. Importantly, efficacy was observed against each of the four dengue serotypes. Additional observations of the results showed a clinically important reduction by 80.3% in the risk of hospitalization due to dengue during the study. The results also showed in the study population an efficacy against dengue haemorrhagic fever, the severe form of dengue, which is consistent with the results released from Sanofi�s Phase III dengue study in Asia. Lastly, the results suggest better protection in case of prior exposure to dengue. A full analysis of the efficacy and safety data from the phase III study will be presented at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting, 2-6 November�2014, in New Orleans, U.S.
�
������������������ In August, detailed positive results from four Phase III ODYSSEY trials (ODYSSEY LONG TERM, ODYSSEY COMBO II, FH I and FH II) of alirocumab, an investigational monoclonal antibody targeting PCSK9, (collaboration with Regeneron), in people with hypercholesterolemia were presented at a Hot Line session at the ESC Congress 2014. All of these four studies met their primary endpoint. Alirocumab showed significant and sustained reductions in LDL-C over one year on top of standard-of-care statin therapy across different patient types. Futhermore, in a post hoc safety analysis of ODYSSEY LONG TERM trial, (designed to evaluate the long-term safety and efficacy of 150 mg alirocumab every two weeks versus placebo in patients with hypercholesterolemia who are at high or very-high cardiovascular risk) there was a lower rate of adjudicated major cardiovascular events (cardiac death, myocardial infarction, stroke, and unstable angina requiring hospitalization) in the alirocumab group compared to placebo (1.4 percent compared to 3.0 percent, nominal p-value <0.01). These cardiovascular events comprise the composite primary endpoint of the ongoing 18,000-patient ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of alirocumab to demonstrate CV benefit.
�
*95 percent CIs overall efficacy [52.0 percent, 68.0 percent]; Efficacy per serotype (ST1 50.3%, ST2 42.3%, ST3 74.0%, ST4 77.7%); 95 percent CIs reduction of the risk of hospitalization [64.7 percent, 89.5 percent]
�
�
������������������ In August, The New England Journal of Medicine published positive results from a large-scale, multi-center efficacy trial, which found that Fluzone��High-Dose (Influenza Vaccine) was more efficacious in preventing influenza in adults 65 years of age and older compared to standard-dose Fluzone��vaccine.� Fluzone��High-Dose vaccine was found to be 24.2 percent (95% CI, 9.7 to 36.5) more effective in preventing influenza relative to standard-dose Fluzone��vaccine for the primary endpoint.
�
Phase II:
�
������������������ In September, Sanofi and Regeneron announced that a Phase IIa proof-of-concept study of dupilumab, an investigational monoclonal antibody that blocks IL-4 and IL-13 signaling (in collaboration with Regeneron), met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps who did not respond to intranasal corticosteroids. In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score, the primary endpoint of the study. The safety profile was consistent with previous studies. The most common adverse events with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
�
������������������ Valetizumab (an anti-VLA2 monoclonal antibody) entered into Phase IIb in multiple sclerosis.
�
������������������ Sanofi and Alopexx have agreed to let Alopexx take primary responsibility for development of SR279356 (an anti-PNAG monoclonal antibody). As a consequence both parties have agreed to terminate their agreement relating to the development of SAR279356.
�
Phase I:
�
������������������ Sanofi and Regeneron have disclosed that the project SAR 438584 (REGN2222) currently in Phase I is a fully human anti-RSV F protein monoclonal antibody under evaluation for the prevention of Respiratory Sincytial Virus�related disease, a leading cause of respiratory morbidity in infants.
�
������������������ SAR408701, an anti-CEACAM5 ADC, entered into Phase I in solid tumors during the quarter.
�
New Collaborations:
�
������������������ In October, Sanofi Pasteur and Immune Design Corp., a clinical-stage immunotherapy company, announced that they have entered into a broad collaboration for the development of a herpes simplex virus (HSV) immune therapy
�
������������������ In August�Sanofi and MannKind announced that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza�, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes.
�
������������������ In September, Sanofi and MyoKardia,�Inc., a privately-held company leading the development of precision therapies for genetic heart disease, announced a worldwide collaboration to discover and develop first-of-its-kind targeted therapeutics for heritable heart diseases known as cardiomyopathies, the most common forms of heart muscle disease.
�
�
Third-quarter and first 9-months 2014 financial results
�
Business Net Income(1)
�
In the third quarter, Sanofi generated net sales of �8,781 million, an increase of 4.1% on a reported basis (up 5.1% at constant exchange rates). Year-to-date sales were �24,698 million, an increase of 0.8% on a reported basis (up 5.0% at constant exchange rates).
�
Other revenues were �87 million (up 1.2%) and �241 million (down 9.7%) in the third quarter and the first nine months, respectively, reflecting the end of royalties on Enbrel��sales in the U.S during Q1 2013.
�
Gross profit was �6,004 million in the third quarter, an increase of 6.3% (up 7.3% at constant exchange rates). The ratio of cost of sales to net sales (CoS ratio) improved by 1.4 percentage points to 32.6%, versus the third quarter of 2013. This reflected the resolution of Toronto manufacturing issues, improved industrial performance of Genzyme combined with higher sales in multiple sclerosis and positive mix effect in the U.S. and China. Year-to-date gross profit was �16,951 million, up 1.6% (or up 6.1% at constant exchange rates). In the first nine months, the ratio of cost of sales to net sales improved by 0.6 percentage points to 32.4% versus the same period of 2013.
�
Research and Development expenses were down 3.0% at �1,146 million in the third quarter. At constant exchange rates, R&D expenses decreased by 2.6% reflecting lower spend in oncology and completion of the Toujeo� EDITION program more than offsetting higher spend on dupilumab. Year-to-date R&D expenses were down 1.4% to �3,473 million (or up 0.6% at constant exchange rates), the ratio of R&D to net sales was 0.3 percentage points lower at 14.1% compared with the same period of 2013.
�
Third-quarter selling and general expenses increased 9.0% to �2,193 million. At constant exchange rates, SG&A increased 10.0% reflecting a rebound of commercial activity in China, higher Advertising�& Promotional expenses in the U.S. on NexGard� and Frontline��as well as Genzyme�s launch investments in multiple sclerosis and Rare Diseases. The ratio of selling and general expenses to net sales was 1.1 percentage points higher to 25.0% compared with the third quarter of 2013. Year-to-date SG&A expenses increased 1.1% to �6,526 million (an increase of 4.9% at constant exchange rates). In the first nine months, the ratio of selling and general expenses to net sales was stable at 26.4%.
�
Other current operating income net of expenses was �39 million in the third quarter versus �28 million in the third quarter of 2013. This quarter included a �40 million gain associated with the termination of a licence of a U.S. product.
�
The share of profits from associates was �43 million in the third quarter (versus �38 million in the third quarter of 2013) and included our share in Regeneron profit recorded under the equity method since the beginning of April�as well as our share of profit in Sanofi Pasteur MSD (the Vaccines joint venture with Merck�& Co. in Europe).
�
Non-controlling interests were -�31 million in the third quarter versus -�36 million in the third quarter of 2013.
�
In the third-quarter, business operating income increased 9.3% to �2,716 million. At constant exchange rates, business operating income grew 11.0%. The ratio of business operating income to net sales improved by 1.4 percentage points to 30.9%. Year-to-date business operating income grew 2.6% to �7,006 million (up 8.6% at constant exchange rates). The ratio of business operating income to net sales was 28.4%, compared to 27.9% in the same period of 2013.
�
Net financial expenses were �139 million in the third quarter compared to �123 million in the third quarter of 2013). Year-to-date net financial expenses were �309 million versus �400 million in the same period of 2013.
�
The third quarter and year-to-date effective tax rate was 25% (versus 24% in the third quarter of 2013).
�
Third-quarter business net income(1)�increased 7.8% to �1,935 million. At constant exchange rates, the growth was 9.4%. The ratio of business net income to net sales improved by 0.7 percentage points to 22.0% in the third quarter of 2014 compared to the third quarter of 2013. Year-to-date business net income grew 3.0% to �5,019�million (an increase of 9.3% at constant exchange rates). The ratio of business net income to net sales improved by 0.4 percentage points to 20.3% compared to the first nine months of 2013.
�
(1)�������� See Appendix 8 for definitions of financial indicators, and Appendix 3 for reconciliation of business net income to consolidated net income attributable to equity holders of Sanofi
�
�
In the third quarter of 2014, business earnings per share(1)�(EPS) was �1.47, up 8.1% on a reported basis and up 10.3% at constant exchange rates. The average number of shares outstanding was 1,313.0 million this quarter versus 1,323.5 million in the third quarter of 2013. In the first nine months of 2014, business earnings per share(1)�was �3.81, up 3.5% on a reported basis and up 10.1% at constant exchange rates. The average number of shares outstanding was 1,315.8 million in the first nine months of 2014 versus 1,323.8 million in the first nine months of 2013.
�
From business net income to consolidated net income (see Appendix 3)
�
In the first nine months of 2014, the main reconciling items between business net income and consolidated net income attributable to equity holders of Sanofi were:
�
������������������ A �1,862 million amortization charge related to fair-value re-measurement on intangible assets of acquired companies (primarily Aventis: �689 million, Genzyme: �608 million and Merial: �294 million) and to acquired intangible assets (licenses/products: �64 million). A �561 million amortization charge on intangible assets related to fair-value re-measurement of acquired companies (primarily Aventis: �182 million, Genzyme: �188�million and Merial: �100 million), and to acquired intangible assets (licenses/products: �21 million) was booked in the third quarter. These items have no cash impact on the Group.
�
������������������ An impairment loss against intangible assets of �109 million (of which �35 million in Q3 2014 mainly related to SAR 279356). This item has no cash impact on the Group.
�
������������������ A charge of �177 million mainly reflecting an increase in the fair value of contingent considerations�related to the CVRs (�21 million, of which a gain of �7 million in Q3 2014) and Bayer contingent considerations (�155 million, of which �51 million in Q3 2014) linked to Lemtrada�.
�
������������������ Restructuring costs of �298 million (including �163 million in Q3 2014 mainly related to transformation in France).
�
������������������ A �35 million gain on Alnylam shares. This item has no cash impact on the Group.
�
������������������ An annual fee of �116 million related to 2013 sales in the U.S. following the final IRS regulation issued in July�2014 that has changed the timing of liability recognition and leads to a one-time �double� expense in 2014.
�
������������������ A �783 million tax effect arising from the items listed above, comprising �639 million generated by amortization charged against intangible assets, �99 million associated with restructuring costs and �39�million associated with impairment against intangible assets. The third quarter tax effect was �261�million, including �188�million of deferred taxes generated by amortization charged against intangible assets, �55 million linked to restructuring costs and �13 million associated with impairment loss on intangible assets (see Appendix 3).
�
������������������ A tax of �110 million on dividends paid to shareholders of Sanofi.
�
������������������ In �Share of profits/losses from associates�, a charge of �118 million, net of tax, 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 (of which �86 million in Q3 2014). This item has no cash impact on the Group.
�
Capital Allocation
�
In the first nine months of 2014, net cash generated by operating activities increased 15.8% to �4,239 million after capital expenditures of �802 million and an increase in working capital by �577 million. This net Cash Flow has contributed to finance a share repurchase (�1,102 million) partially offset by proceeds from the issuance of new shares (�635 million), dividend paid by Sanofi (�3,676 million), acquisitions and partnerships net of disposals (�2,220 million of which �1,492 million was related to Regeneron and �535 million was related to Alnylam) and restructuring costs (�603�million).
�
(1)�������� See Appendix 8 for definitions of financial indicators, and Appendix 3 for reconciliation of business net income to consolidated net income attributable to equity holders of Sanofi
�
�
As a consequence, net debt increased from �6,043 million at December�31, 2013 to �9,228 million at the end of September�2014 (amount net of �6,526 million cash and cash equivalents).
�
Forward-Looking Statements
�
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words �expects�, �anticipates�, �believes�, �intends�, �estimates�, �plans� and similar expressions. Although Sanofi�s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, 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, 2013. 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:���������������������������� 2014 third-quarter and 2014 9-month of consolidated net sales by geographic region and product
�
Appendix 2:���������������������������� 2014 third-quarter and 2014 9-month business net income statement
�
Appendix 3:���������������������������� Reconciliation of business net income to net income attributable to equity holders of Sanofi
�
Appendix 4:���������������������������� 2014 third-quarter and 2014 9-month consolidated income statement
�
Appendix 5:���������������������������� 2014 currency sensitivity
�
Appendix 6:���������������������������� R&D pipeline
�
Appendix 7:���������������������������� Expected R&D milestones in H2 2014 / 9M 2015
�
Appendix 8:���������������������������� Definitions
�
�
Appendix 1: 2014 Third-quarter and 9-month consolidated net sales by geographic region and product
�
|
Q3�2014�net�sales |
� |
Total |
� |
%�CER |
� |
%�reported |
� |
Western |
� |
%�CER |
� |
United |
� |
%�CER |
� |
Emerging |
� |
%�CER |
� |
Rest�of�the |
� |
%�CER |
� |
|
Lantus |
� |
1,567 |
� |
8.1 |
% |
7.6 |
% |
222 |
� |
9.5 |
% |
1,042 |
� |
5.8 |
% |
232 |
� |
19.7 |
% |
71 |
� |
4.2 |
% |
|
Apidra |
� |
88 |
� |
21.9 |
% |
20.5 |
% |
26 |
� |
19.0 |
% |
35 |
� |
20.7 |
% |
19 |
� |
25.0 |
% |
8 |
� |
28.6 |
% |
|
Amaryl |
� |
87 |
� |
-2.2 |
% |
-4.4 |
% |
5 |
� |
0.0 |
% |
2 |
� |
� |
� |
68 |
� |
6.2 |
% |
12 |
� |
-38.1 |
% |
|
Insuman |
� |
34 |
� |
0.0 |
% |
0.0 |
% |
21 |
� |
-4.5 |
% |
0 |
� |
� |
� |
13 |
� |
8.3 |
% |
0 |
� |
� |
� |
|
Lyxumia |
� |
8 |
� |
166.7 |
% |
166.7 |
% |
4 |
� |
100.0 |
% |
0 |
� |
� |
� |
2 |
� |
� |
� |
2 |
� |
100.0 |
% |
|
Diabetes |
� |
1,799 |
� |
8.3 |
% |
7.7 |
% |
292 |
� |
10.3 |
% |
1,079 |
� |
6.4 |
% |
336 |
� |
17.5 |
% |
92 |
� |
-3.9 |
% |
|
Taxotere |
� |
59 |
� |
-28.6 |
% |
-29.8 |
% |
3 |
� |
-40.0 |
% |
2 |
� |
-33.3 |
% |
35 |
� |
-23.9 |
% |
19 |
� |
-33.3 |
% |
|
Jevtana (*) |
� |
67 |
� |
15.3 |
% |
13.6 |
% |
34 |
� |
22.2 |
% |
23 |
� |
9.5 |
% |
8 |
� |
12.5 |
% |
2 |
� |
0.0 |
% |
|
Eloxatine |
� |
43 |
� |
-12.0 |
% |
-14.0 |
% |
2 |
� |
0.0 |
% |
-4 |
� |
-500.0 |
% |
31 |
� |
-3.1 |
% |
14 |
� |
0.0 |
% |
|
Thymoglobulin |
� |
54 |
� |
3.8 |
% |
3.8 |
% |
8 |
� |
0.0 |
% |
28 |
� |
7.7 |
% |
14 |
� |
-12.5 |
% |
4 |
� |
100.0 |
% |
|
Mozobil (*) |
� |
29 |
� |
20.0 |
% |
16.0 |
% |
10 |
� |
12.5 |
% |
17 |
� |
21.4 |
% |
2 |
� |
0.0 |
% |
0 |
� |
� |
� |
|
Zaltrap (*) |
� |
18 |
� |
30.8 |
% |
38.5 |
% |
9 |
� |
100.0 |
% |
6 |
� |
-25.0 |
% |
2 |
� |
� |
� |
1 |
� |
� |
� |
|
Other Oncology |
� |
61 |
� |
-6.3 |
% |
-4.7 |
% |
14 |
� |
7.7 |
% |
34 |
� |
-12.2 |
% |
8 |
� |
-14.3 |
% |
5 |
� |
33.3 |
% |
|
Oncology |
� |
331 |
� |
-4.0 |
% |
-4.6 |
% |
80 |
� |
16.2 |
% |
106 |
� |
-5.3 |
% |
100 |
� |
-10.7 |
% |
45 |
� |
-13.2 |
% |
|
Aubagio |
� |
112 |
� |
156.8 |
% |
154.5 |
% |
18 |
� |
� |
� |
87 |
� |
97.7 |
% |
3 |
� |
300.0 |
% |
4 |
� |
-500.0 |
% |
|
Lemtrada |
� |
7 |
� |
� |
� |
� |
� |
6 |
� |
� |
� |
0 |
� |
� |
� |
1 |
� |
� |
� |
0 |
� |
� |
� |
|
Cerezyme |
� |
175 |
� |
9.1 |
% |
6.1 |
% |
60 |
� |
15.4 |
% |
48 |
� |
4.3 |
% |
56 |
� |
7.0 |
% |
11 |
� |
10.0 |
% |
|
Myozyme |
� |
138 |
� |
9.4 |
% |
8.7 |
% |
69 |
� |
1.5 |
% |
35 |
� |
9.4 |
% |
25 |
� |
42.1 |
% |
9 |
� |
0.0 |
% |
|
Fabrazyme |
� |
116 |
� |
21.9 |
% |
20.8 |
% |
28 |
� |
40.0 |
% |
58 |
� |
14.0 |
% |
15 |
� |
33.3 |
% |
15 |
� |
14.3 |
% |
|
Aldurazyme |
� |
41 |
� |
7.9 |
% |
7.9 |
% |
16 |
� |
14.3 |
% |
8 |
� |
28.6 |
% |
12 |
� |
0.0 |
% |
5 |
� |
-20.0 |
% |
|
Other Rare Diseases products |
� |
60 |
� |
3.4 |
% |
1.7 |
% |
10 |
� |
-10.0 |
% |
23 |
� |
0.0 |
% |
12 |
� |
20.0 |
% |
15 |
� |
6.3 |
% |
|
Genzyme |
� |
649 |
� |
24.6 |
% |
22.7 |
% |
207 |
� |
25.0 |
% |
259 |
� |
28.2 |
% |
124 |
� |
19.8 |
% |
59 |
� |
19.2 |
% |
|
Plavix |
� |
450 |
� |
9.0 |
% |
6.4 |
% |
52 |
� |
-17.5 |
% |
0 |
� |
� |
� |
203 |
� |
21.3 |
% |
195 |
� |
6.8 |
% |
|
Lovenox |
� |
426 |
� |
7.2 |
% |
6.2 |
% |
221 |
� |
5.8 |
% |
34 |
� |
-12.8 |
% |
147 |
� |
16.9 |
% |
24 |
� |
0.0 |
% |
|
Aprovel |
� |
178 |
� |
-14.8 |
% |
-15.2 |
% |
41 |
� |
-47.4 |
% |
4 |
� |
0.0 |
% |
105 |
� |
9.3 |
% |
28 |
� |
-9.7 |
% |
|
Renagel And Renvela |
� |
162 |
� |
-13.4 |
% |
-13.4 |
% |
32 |
� |
0.0 |
% |
103 |
� |
-22.0 |
% |
22 |
� |
22.2 |
% |
5 |
� |
0.0 |
% |
|
Allegra |
� |
32 |
� |
-52.1 |
% |
-54.9 |
% |
2 |
� |
0.0 |
% |
0 |
� |
-100.0 |
% |
1 |
� |
-96.7 |
% |
29 |
� |
-24.4 |
% |
|
Stilnox |
� |
78 |
� |
-16.0 |
% |
-17.0 |
% |
10 |
� |
-9.1 |
% |
19 |
� |
-5.0 |
% |
16 |
� |
0.0 |
% |
33 |
� |
-27.7 |
% |
|
Depakine |
� |
100 |
� |
-1.0 |
% |
-2.0 |
% |
36 |
� |
0.0 |
% |
0 |
� |
� |
� |
61 |
� |
0.0 |
% |
3 |
� |
-25.0 |
% |
|
Synvisc / Synvisc One |
� |
88 |
� |
-2.2 |
% |
-2.2 |
% |
6 |
� |
0.0 |
% |
69 |
� |
-4.2 |
% |
11 |
� |
10.0 |
% |
2 |
� |
0.0 |
% |
|
Tritace |
� |
69 |
� |
-5.3 |
% |
-8.0 |
% |
31 |
� |
-8.8 |
% |
0 |
� |
� |
� |
38 |
� |
0.0 |
% |
0 |
� |
-33.3 |
% |
|
Multaq (*) |
� |
76 |
� |
13.4 |
% |
13.4 |
% |
11 |
� |
10.0 |
% |
62 |
� |
17.0 |
% |
3 |
� |
0.0 |
% |
0 |
� |
-50.0 |
% |
|
Lasix |
� |
42 |
� |
2.3 |
% |
-2.3 |
% |
19 |
� |
0.0 |
% |
1 |
� |
0.0 |
% |
13 |
� |
18.2 |
% |
9 |
� |
-8.3 |
% |
|
Targocid |
� |
40 |
� |
8.1 |
% |
8.1 |
% |
20 |
� |
17.6 |
% |
0 |
� |
� |
� |
17 |
� |
5.9 |
% |
3 |
� |
-33.3 |
% |
|
Orudis |
� |
33 |
� |
-8.3 |
% |
-8.3 |
% |
4 |
� |
0.0 |
% |
0 |
� |
� |
� |
28 |
� |
-12.9 |
% |
1 |
� |
� |
� |
|
Cordarone |
� |
31 |
� |
-3.0 |
% |
-6.1 |
% |
6 |
� |
0.0 |
% |
0 |
� |
� |
� |
17 |
� |
6.3 |
% |
8 |
� |
-18.2 |
% |
|
Xatral |
� |
22 |
� |
-15.4 |
% |
-15.4 |
% |
9 |
� |
-10.0 |
% |
0 |
� |
-100.0 |
% |
13 |
� |
-14.3 |
% |
0 |
� |
0.0 |
% |
|
Actonel |
� |
21 |
� |
-8.7 |
% |
-8.7 |
% |
4 |
� |
-33.3 |
% |
0 |
� |
� |
� |
11 |
� |
0.0 |
% |
6 |
� |
0.0 |
% |
|
Auvi-Q / Allerject (*) |
� |
37 |
� |
26.7 |
% |
23.3 |
% |
1 |
� |
� |
� |
33 |
� |
22.2 |
% |
0 |
� |
� |
� |
3 |
� |
33.3 |
% |
|
Other Rx Drugs |
� |
881 |
� |
-12.1 |
% |
-13.1 |
% |
382 |
� |
-3.3 |
% |
75 |
� |
-37.8 |
% |
324 |
� |
-12.1 |
% |
100 |
� |
-16.1 |
% |
|
Total Other Rx Drugs |
� |
2,766 |
� |
-5.4 |
% |
-6.6 |
% |
887 |
� |
-5.4 |
% |
400 |
� |
-14.4 |
% |
1,030 |
� |
-0.6 |
% |
449 |
� |
-7.2 |
% |
|
Consumer Healthcare |
� |
819 |
� |
12.9 |
% |
10.4 |
% |
157 |
� |
0.0 |
% |
158 |
� |
3.3 |
% |
452 |
� |
26.2 |
% |
52 |
� |
-11.9 |
% |
|
Generics |
� |
451 |
� |
8.3 |
% |
6.4 |
% |
125 |
� |
-3.9 |
% |
28 |
� |
-24.3 |
% |
287 |
� |
19.8 |
% |
11 |
� |
0.0 |
% |
|
Pharmaceuticals |
� |
6,815 |
� |
3.4 |
% |
2.1 |
% |
1,748 |
� |
1.3 |
% |
2,030 |
� |
2.3 |
% |
2,329 |
� |
9.2 |
% |
708 |
� |
-5.7 |
% |
|
Polio Pertussis |
� |
259 |
� |
7.4 |
% |
6.1 |
% |
8 |
� |
0.0 |
% |
97 |
� |
94.0 |
% |
120 |
� |
-20.6 |
% |
34 |
� |
9.7 |
% |
|
Influenza Vaccines |
� |
650 |
� |
15.0 |
% |
16.3 |
% |
89 |
� |
15.6 |
% |
456 |
� |
11.7 |
% |
99 |
� |
31.6 |
% |
6 |
� |
25.0 |
% |
|
Meningite/Pneumonie |
� |
191 |
� |
-10.0 |
% |
-9.5 |
% |
2 |
� |
100.0 |
% |
168 |
� |
-6.1 |
% |
19 |
� |
-34.5 |
% |
2 |
� |
-50.0 |
% |
|
Adult Booster Vaccines |
� |
131 |
� |
54.8 |
% |
56.0 |
% |
28 |
� |
107.7 |
% |
90 |
� |
58.9 |
% |
11 |
� |
-8.3 |
% |
2 |
� |
0.0 |
% |
|
Travel And Other Andemics Vaccines |
� |
99 |
� |
-3.0 |
% |
-2.0 |
% |
6 |
� |
50.0 |
% |
31 |
� |
-18.4 |
% |
50 |
� |
6.3 |
% |
12 |
� |
-9.1 |
% |
|
Other Vaccines |
� |
121 |
� |
21.8 |
% |
19.8 |
% |
0 |
� |
-50.0 |
% |
116 |
� |
21.3 |
% |
5 |
� |
300.0 |
% |
0 |
� |
0.0 |
% |
|
Vaccines |
� |
1,451 |
� |
11.2 |
% |
11.6 |
% |
133 |
� |
26.7 |
% |
958 |
� |
15.8 |
% |
304 |
� |
-4.0 |
% |
56 |
� |
3.6 |
% |
|
Fipronil products |
� |
143 |
� |
-5.3 |
% |
-5.3 |
% |
39 |
� |
-4.9 |
% |
67 |
� |
-9.6 |
% |
28 |
� |
16.0 |
% |
9 |
� |
-25.0 |
% |
|
Nexgard |
� |
27 |
� |
� |
� |
� |
� |
3 |
� |
� |
� |
23 |
� |
� |
� |
1 |
� |
� |
� |
0 |
� |
� |
� |
|
Vaccines |
� |
176 |
� |
11.3 |
% |
10.0 |
% |
47 |
� |
23.7 |
% |
40 |
� |
11.1 |
% |
84 |
� |
6.1 |
% |
5 |
� |
0.0 |
% |
|
Avermectin products |
� |
101 |
� |
11.1 |
% |
12.2 |
% |
11 |
� |
0.0 |
% |
61 |
� |
27.1 |
% |
14 |
� |
7.1 |
% |
15 |
� |
-25.0 |
% |
|
Others |
� |
68 |
� |
21.1 |
% |
19.3 |
% |
22 |
� |
-5.0 |
% |
29 |
� |
45.0 |
% |
16 |
� |
15.4 |
% |
1 |
� |
50.0 |
% |
|
Animal Health |
� |
515 |
� |
12.7 |
% |
12.4 |
% |
122 |
� |
8.1 |
% |
220 |
� |
23.2 |
% |
143 |
� |
9.7 |
% |
30 |
� |
-13.9 |
% |
|
Total Group |
� |
8,781 |
� |
5.1 |
% |
4.1 |
% |
2,003 |
� |
3.1 |
% |
3,208 |
� |
7.2 |
% |
2,776 |
� |
7.6 |
% |
794 |
� |
-5.4 |
% |
�
�
�
|
9�months�net�sales |
� |
Total |
� |
%�CER |
� |
%�reported |
� |
Western |
� |
%�CER |
� |
United |
� |
%�CER |
� |
Emerging |
� |
%�CER |
� |
Rest�of�the |
� |
%�CER |
� |
|
Lantus |
� |
4,572 |
� |
12.5 |
% |
8.8 |
% |
643 |
� |
6.5 |
% |
3,028 |
� |
13.3 |
% |
700 |
� |
17.8 |
% |
201 |
� |
4.2 |
% |
|
Apidra |
� |
240 |
� |
20.3 |
% |
15.9 |
% |
73 |
� |
18.0 |
% |
90 |
� |
17.9 |
% |
54 |
� |
28.3 |
% |
23 |
� |
18.2 |
% |
|
Amaryl |
� |
269 |
� |
0.7 |
% |
-5.3 |
% |
15 |
� |
-11.8 |
% |
3 |
� |
200.0 |
% |
210 |
� |
9.9 |
% |
41 |
� |
-28.6 |
% |
|
Insuman |
� |
99 |
� |
3.0 |
% |
0.0 |
% |
61 |
� |
-9.0 |
% |
1 |
� |
0.0 |
% |
37 |
� |
29.0 |
% |
0 |
� |
� |
� |
|
Lyxumia |
� |
19 |
� |
375.0 |
% |
375.0 |
% |
11 |
� |
266.7 |
% |
0 |
� |
� |
� |
3 |
� |
� |
� |
5 |
� |
400.0 |
% |
|
Diabetes |
� |
5,249 |
� |
12.5 |
% |
8.6 |
% |
846 |
� |
7.7 |
% |
3,122 |
� |
13.5 |
% |
1,007 |
� |
17.5 |
% |
274 |
� |
1.0 |
% |
|
Taxotere |
� |
195 |
� |
-31.7 |
% |
-36.3 |
% |
11 |
� |
-42.1 |
% |
7 |
� |
-78.8 |
% |
110 |
� |
-25.0 |
% |
67 |
� |
-24.5 |
% |
|
Jevtana (*) |
� |
199 |
� |
23.6 |
% |
20.6 |
% |
106 |
� |
38.2 |
% |
65 |
� |
6.3 |
% |
25 |
� |
27.3 |
% |
3 |
� |
0.0 |
% |
|
Eloxatine |
� |
136 |
� |
-14.2 |
% |
-19.5 |
% |
4 |
� |
-20.0 |
% |
-3 |
� |
-118.8 |
% |
90 |
� |
-3.1 |
% |
45 |
� |
-2.0 |
% |
|
Thymoglobulin |
� |
160 |
� |
11.5 |
% |
8.1 |
% |
24 |
� |
4.3 |
% |
78 |
� |
5.3 |
% |
49 |
� |
27.5 |
% |
9 |
� |
11.1 |
% |
|
Mozobil (*) |
� |
80 |
� |
7.9 |
% |
5.3 |
% |
26 |
� |
4.2 |
% |
44 |
� |
7.1 |
% |
8 |
� |
12.5 |
% |
2 |
� |
50.0 |
% |
|
Zaltrap (*) |
� |
49 |
� |
28.9 |
% |
28.9 |
% |
25 |
� |
177.8 |
% |
20 |
� |
-28.6 |
% |
4 |
� |
300.0 |
% |
0 |
� |
� |
� |
|
Other Oncology |
� |
192 |
� |
3.7 |
% |
1.6 |
% |
43 |
� |
4.9 |
% |
112 |
� |
3.5 |
% |
23 |
� |
4.5 |
% |
14 |
� |
0.0 |
% |
|
Oncology |
� |
1,011 |
� |
-3.8 |
% |
-7.3 |
% |
239 |
� |
20.3 |
% |
323 |
� |
-10.2 |
% |
309 |
� |
-5.8 |
% |
140 |
� |
-13.0 |
% |
|
Aubagio |
� |
287 |
� |
205.2 |
% |
195.9 |
% |
56 |
� |
� |
� |
218 |
� |
130.9 |
% |
6 |
� |
700.0 |
% |
7 |
� |
-900.0 |
% |
|
Lemtrada |
� |
18 |
� |
� |
� |
� |
� |
16 |
� |
� |
� |
0 |
� |
� |
� |
1 |
� |
� |
� |
1 |
� |
� |
� |
|
Cerezyme |
� |
518 |
� |
8.3 |
% |
2.2 |
% |
179 |
� |
8.5 |
% |
138 |
� |
6.0 |
% |
171 |
� |
12.1 |
% |
30 |
� |
-2.9 |
% |
|
Myozyme |
� |
392 |
� |
9.2 |
% |
6.2 |
% |
199 |
� |
-2.5 |
% |
99 |
� |
10.9 |
% |
71 |
� |
47.2 |
% |
23 |
� |
19.0 |
% |
|
Fabrazyme |
� |
337 |
� |
26.2 |
% |
20.8 |
% |
81 |
� |
32.8 |
% |
164 |
� |
14.3 |
% |
51 |
� |
58.3 |
% |
41 |
� |
31.4 |
% |
|
Aldurazyme |
� |
127 |
� |
13.8 |
% |
9.5 |
% |
48 |
� |
6.8 |
% |
24 |
� |
19.0 |
% |
43 |
� |
20.5 |
% |
12 |
� |
8.3 |
% |
|
Other Rare Diseases products |
� |
179 |
� |
3.4 |
% |
0.0 |
% |
31 |
� |
3.3 |
% |
63 |
� |
-11.0 |
% |
37 |
� |
39.3 |
% |
48 |
� |
4.2 |
% |
|
Genzyme |
� |
1,858 |
� |
25.1 |
% |
20.1 |
% |
610 |
� |
20.9 |
% |
706 |
� |
28.7 |
% |
380 |
� |
28.4 |
% |
162 |
� |
18.8 |
% |
|
Plavix |
� |
1,362 |
� |
5.8 |
% |
-0.3 |
% |
168 |
� |
-14.7 |
% |
1 |
� |
-80.0 |
% |
629 |
� |
10.4 |
% |
564 |
� |
8.8 |
% |
|
Lovenox |
� |
1,263 |
� |
2.9 |
% |
-0.2 |
% |
672 |
� |
5.3 |
% |
95 |
� |
-27.9 |
% |
430 |
� |
10.0 |
% |
66 |
� |
-1.4 |
% |
|
Aprovel |
� |
550 |
� |
-17.9 |
% |
-20.2 |
% |
147 |
� |
-45.8 |
% |
13 |
� |
30.0 |
% |
306 |
� |
3.9 |
% |
84 |
� |
-14.0 |
% |
|
Renagel And Renvela |
� |
471 |
� |
-9.0 |
% |
-11.6 |
% |
97 |
� |
-3.0 |
% |
305 |
� |
-14.7 |
% |
55 |
� |
20.0 |
% |
14 |
� |
-6.7 |
% |
|
Allegra |
� |
151 |
� |
-47.6 |
% |
-52.7 |
% |
8 |
� |
0.0 |
% |
0 |
� |
-100.0 |
% |
4 |
� |
-95.6 |
% |
139 |
� |
-30.5 |
% |
|
Stilnox |
� |
229 |
� |
-15.3 |
% |
-20.2 |
% |
31 |
� |
-3.1 |
% |
53 |
� |
-8.5 |
% |
48 |
� |
0.0 |
% |
97 |
� |
-26.0 |
% |
|
Depakine |
� |
291 |
� |
-2.6 |
% |
-6.4 |
% |
103 |
� |
0.0 |
% |
0 |
� |
� |
� |
178 |
� |
-3.5 |
% |
10 |
� |
-9.1 |
% |
|
Synvisc / Synvisc One |
� |
251 |
� |
-4.8 |
% |
-7.7 |
% |
20 |
� |
11.1 |
% |
196 |
� |
-7.4 |
% |
28 |
� |
20.0 |
% |
7 |
� |
-33.3 |
% |
|
Tritace |
� |
212 |
� |
-5.6 |
% |
-9.0 |
% |
96 |
� |
-6.8 |
% |
0 |
� |
� |
� |
112 |
� |
-2.5 |
% |
4 |
� |
-37.5 |
% |
|
Multaq (*) |
� |
215 |
� |
11.1 |
% |
8.6 |
% |
33 |
� |
6.5 |
% |
174 |
� |
12.6 |
% |
7 |
� |
16.7 |
% |
1 |
� |
-50.0 |
% |
|
Lasix |
� |
123 |
� |
3.2 |
% |
-2.4 |
% |
59 |
� |
5.4 |
% |
2 |
� |
0.0 |
% |
38 |
� |
16.7 |
% |
24 |
� |
-15.6 |
% |
|
Targocid |
� |
115 |
� |
-5.6 |
% |
-8.0 |
% |
61 |
� |
0.0 |
% |
0 |
� |
� |
� |
48 |
� |
-7.1 |
% |
6 |
� |
-33.3 |
% |
|
Orudis |
� |
116 |
� |
14.7 |
% |
6.4 |
% |
14 |
� |
-16.7 |
% |
0 |
� |
� |
� |
99 |
� |
20.2 |
% |
3 |
� |
50.0 |
% |
|
Cordarone |
� |
96 |
� |
-1.9 |
% |
-8.6 |
% |
18 |
� |
-5.3 |
% |
0 |
� |
� |
� |
53 |
� |
3.6 |
% |
25 |
� |
-9.7 |
% |
|
Xatral |
� |
69 |
� |
-7.8 |
% |
-10.4 |
% |
28 |
� |
-3.4 |
% |
0 |
� |
-100.0 |
% |
40 |
� |
-2.3 |
% |
1 |
� |
-50.0 |
% |
|
Actonel |
� |
62 |
� |
-12.0 |
% |
-17.3 |
% |
13 |
� |
-23.5 |
% |
0 |
� |
� |
� |
32 |
� |
-5.6 |
% |
17 |
� |
-13.6 |
% |
|
Auvi-Q / Allerject (*) |
� |
63 |
� |
32.7 |
% |
28.6 |
% |
2 |
� |
0.0 |
% |
54 |
� |
31.0 |
% |
0 |
� |
� |
� |
7 |
� |
60.0 |
% |
|
Other Rx Drugs |
� |
2,717 |
� |
-10.5 |
% |
-13.9 |
% |
1,156 |
� |
-5.9 |
% |
272 |
� |
-25.1 |
% |
1,015 |
� |
-9.0 |
% |
274 |
� |
-16.6 |
% |
|
Total Other Rx Drugs |
� |
8,356 |
� |
-6.3 |
% |
-10.1 |
% |
2,726 |
� |
-7.0 |
% |
1,165 |
� |
-12.8 |
% |
3,122 |
� |
-1.6 |
% |
1,343 |
� |
-9.3 |
% |
|
Consumer Healthcare |
� |
2,520 |
� |
17.3 |
% |
10.4 |
% |
518 |
� |
0.0 |
% |
536 |
� |
15.0 |
% |
1,321 |
� |
32.4 |
% |
145 |
� |
-16.8 |
% |
|
Generics |
� |
1,338 |
� |
23.2 |
% |
16.7 |
% |
400 |
� |
-3.2 |
% |
94 |
� |
-32.6 |
% |
815 |
� |
56.4 |
% |
29 |
� |
22.2 |
% |
|
Pharmaceuticals |
� |
20,332 |
� |
5.1 |
% |
0.7 |
% |
5,339 |
� |
-0.2 |
% |
5,946 |
� |
6.1 |
% |
6,954 |
� |
12.9 |
% |
2,093 |
� |
-6.8 |
% |
|
Polio Pertussis |
� |
754 |
� |
-2.4 |
% |
-6.6 |
% |
20 |
� |
-20.0 |
% |
263 |
� |
56.1 |
% |
361 |
� |
-19.1 |
% |
110 |
� |
-15.5 |
% |
|
Influenza Vaccines |
� |
844 |
� |
16.0 |
% |
15.5 |
% |
90 |
� |
15.4 |
% |
477 |
� |
14.1 |
% |
259 |
� |
20.2 |
% |
18 |
� |
11.1 |
% |
|
Meningite/Pneumonie |
� |
362 |
� |
-10.4 |
% |
-12.6 |
% |
2 |
� |
-50.0 |
% |
299 |
� |
1.3 |
% |
56 |
� |
-42.9 |
% |
5 |
� |
0.0 |
% |
|
Adult Booster Vaccines |
� |
295 |
� |
3.1 |
% |
0.7 |
% |
44 |
� |
-15.4 |
% |
213 |
� |
10.1 |
% |
30 |
� |
-6.1 |
% |
8 |
� |
-10.0 |
% |
|
Travel And Other Andemics Vaccines |
� |
277 |
� |
5.9 |
% |
1.5 |
% |
19 |
� |
58.3 |
% |
77 |
� |
1.3 |
% |
144 |
� |
4.1 |
% |
37 |
� |
5.3 |
% |
|
Other Vaccines |
� |
265 |
� |
14.2 |
% |
10.9 |
% |
1 |
� |
-50.0 |
% |
248 |
� |
14.0 |
% |
10 |
� |
42.9 |
% |
6 |
� |
12.5 |
% |
|
Vaccines |
� |
2,797 |
� |
4.1 |
% |
1.5 |
% |
176 |
� |
1.7 |
% |
1,577 |
� |
15.3 |
% |
860 |
� |
-8.4 |
% |
184 |
� |
-8.1 |
% |
|
Fipronil products |
� |
483 |
� |
-3.3 |
% |
-6.2 |
% |
151 |
� |
-1.3 |
% |
231 |
� |
-9.2 |
% |
74 |
� |
12.5 |
% |
27 |
� |
0.0 |
% |
|
Nexgard |
� |
85 |
� |
� |
� |
� |
� |
7 |
� |
� |
� |
76 |
� |
� |
� |
1 |
� |
� |
� |
1 |
� |
� |
� |
|
Vaccines |
� |
510 |
� |
1.7 |
% |
-2.1 |
% |
135 |
� |
4.7 |
% |
112 |
� |
2.7 |
% |
250 |
� |
-0.4 |
% |
13 |
� |
7.7 |
% |
|
Avermectin products |
� |
313 |
� |
-3.3 |
% |
-6.6 |
% |
39 |
� |
-2.5 |
% |
185 |
� |
-3.0 |
% |
39 |
� |
2.4 |
% |
50 |
� |
-8.9 |
% |
|
Others |
� |
178 |
� |
8.2 |
% |
4.7 |
% |
62 |
� |
-1.6 |
% |
65 |
� |
8.2 |
% |
43 |
� |
27.8 |
% |
8 |
� |
0.0 |
% |
|
Animal Health |
� |
1,569 |
� |
5.3 |
% |
1.8 |
% |
394 |
� |
2.4 |
% |
669 |
� |
8.9 |
% |
407 |
� |
4.8 |
% |
99 |
� |
-2.7 |
% |
|
Total Group |
� |
24,698 |
� |
5.0 |
% |
0.8 |
% |
5,909 |
� |
0.0 |
% |
8,192 |
� |
8.0 |
% |
8,221 |
� |
9.9 |
% |
2,376 |
� |
-6.8 |
% |
�
�
Appendix 2: Business net income statement
�
|
Third�quarter�2014 |
� |
Group�Total |
� |
Pharmaceuticals |
� |
Vaccines |
� |
Animal�Health |
� |
Others |
� | ||||||||||||||||||
|
� million |
� |
Q3�2014 |
� |
Q3�2013(1) |
� |
Change |
� |
Q3�2014 |
� |
Q3�2013(1) |
� |
Change |
� |
Q3�2014 |
� |
Q3�2013(1) |
� |
Change |
� |
Q3�2014 |
� |
Q3�2013(1) |
� |
Change |
� |
Q3�2014 |
� |
Q3�2013(1) |
� |
|
Net sales |
� |
8,781 |
� |
8,432 |
� |
4.1 |
% |
6,815 |
� |
6,674 |
� |
2.1 |
% |
1,451 |
� |
1,300 |
� |
11.6 |
% |
515 |
� |
458 |
� |
12.4 |
% |
� |
� |
� |
� |
|
Other revenues |
� |
87 |
� |
86 |
� |
1.2 |
% |
69 |
� |
69 |
� |
� |
� |
9 |
� |
9 |
� |
� |
� |
9 |
� |
8 |
� |
12.5 |
% |
� |
� |
� |
� |
|
Cost of sales |
� |
(2,864 |
) |
(2,870 |
) |
(0.2 |
)% |
(2,036 |
) |
(2,133 |
) |
(4.5 |
)% |
(629 |
) |
(580 |
) |
8.4 |
% |
(199 |
) |
(157 |
) |
26.8 |
% |
� |
� |
� |
� |
|
As % of net sales |
� |
(32.6 |
)% |
(34.0 |
)% |
� |
� |
(29.9 |
)% |
(32.0 |
)% |
� |
� |
(43.3 |
)% |
(44.6 |
)% |
� |
� |
(38.6 |
)% |
(34.2 |
)% |
� |
� |
� |
� |
� |
� |
|
Gross profit |
� |
6,004 |
� |
5,648 |
� |
6.3 |
% |
4,848 |
� |
4,610 |
� |
5.2 |
% |
831 |
� |
729 |
� |
14.0 |
% |
325 |
� |
309 |
� |
5.2 |
% |
� |
� |
� |
� |
|
As % of net sales |
� |
68.4 |
% |
67.0 |
% |
� |
� |
71.1 |
% |
69.1 |
% |
� |
� |
57.3 |
% |
56.1 |
% |
� |
� |
63.1 |
% |
67.5 |
% |
� |
� |
� |
� |
� |
� |
|
Research and development expenses |
� |
(1,146 |
) |
(1,182 |
) |
(3.0 |
)% |
(987 |
) |
(1,011 |
) |
(2.4 |
)% |
(121 |
) |
(133 |
) |
(9.0 |
)% |
(38 |
) |
(38 |
) |
� |
� |
� |
� |
� |
� |
|
As % of net sales |
� |
(13.1 |
)% |
(14.0 |
)% |
� |
� |
(14.5 |
)% |
(15.1 |
)% |
� |
� |
(8.3 |
)% |
(10.2 |
)% |
� |
� |
(7.4 |
)% |
(8.3 |
)% |
� |
� |
� |
� |
� |
� |
|
Selling and general expenses |
� |
(2,193 |
) |
(2,012 |
) |
9.0 |
% |
(1,859 |
) |
(1,706 |
) |
9.0 |
% |
(170 |
) |
(154 |
) |
10.4 |
% |
(164 |
) |
(152 |
) |
7.9 |
% |
� |
� |
� |
� |
|
As % of net sales |
� |
(25.0 |
)% |
(23.9 |
)% |
� |
� |
(27.3 |
)% |
(25.6 |
)% |
� |
� |
(11.7 |
)% |
(11.8 |
)% |
� |
� |
(31.8 |
)% |
(33.2 |
)% |
� |
� |
� |
� |
� |
� |
|
Other current operating income/expenses |
� |
39 |
� |
28 |
� |
� |
� |
57 |
� |
33 |
� |
� |
� |
2 |
� |
(1 |
) |
� |
� |
1 |
� |
(1 |
) |
� |
� |
(21 |
) |
(3 |
) |
|
Share of profit/loss of associates* and joint ventures |
� |
43 |
� |
38 |
� |
� |
� |
22 |
� |
3 |
� |
� |
� |
21 |
� |
36 |
� |
� |
� |
� |
� |
(1 |
) |
� |
� |
� |
� |
� |
� |
|
Net income attributable to non-controlling interests |
� |
(31 |
) |
(36 |
) |
� |
� |
(31 |
) |
(37 |
) |
� |
� |
� |
� |
1 |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Business operating income |
� |
2,716 |
� |
2,484 |
� |
9.3 |
% |
2,050 |
� |
1,892 |
� |
8.4 |
% |
563 |
� |
478 |
� |
17.8 |
% |
124 |
� |
117 |
� |
6.0 |
% |
(21 |
) |
(3 |
) |
|
As % of net sales |
� |
30.9 |
% |
29.5 |
% |
� |
� |
30.1 |
% |
28.3 |
% |
� |
� |
38.8 |
% |
36.8 |
% |
� |
� |
24.1 |
% |
25.5 |
% |
� |
� |
� |
� |
� |
� |
|
Financial income and expenses |
� |
(139 |
) |
(123 |
) |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Income tax expense |
� |
(642 |
) |
(566 |
) |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Tax rate** |
� |
25.0 |
% |
24.0 |
% |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Business net income |
� |
1,935 |
� |
1,795 |
� |
7.8 |
% |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
As % of net sales |
� |
22.0 |
% |
21.3 |
% |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Business earnings per share*** (in euros) |
� |
1.47 |
� |
1.36 |
� |
8.1 |
% |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
�
*����� Net of tax.
**�� Determined on the basis of Business income before tax, associates and non-controlling interests.
*** Based on an average number of shares outstanding of 1,313.0 million in the third quarter of 2014 and 1,323.5 million in the third quarter of 2013.
(1)�� Including impact of transition to IFRIC 21.
�
�
|
Nine�months�2014 |
� |
Group�Total |
� |
Pharmaceuticals |
� |
Vaccines |
� |
Animal�Health |
� |
Others |
� | ||||||||||||||||||
|
� million |
� |
9M�2014 |
� |
9M�2013(1) |
� |
Change |
� |
9M�2014 |
� |
9M�2013(1) |
� |
Change |
� |
9M�2014 |
� |
9M�2013(1) |
� |
Change |
� |
9M�2014 |
� |
9M�2013(1) |
� |
Change |
� |
9M�2014 |
� |
9M�2013(1) |
� |
|
Net sales |
� |
24,698 |
� |
24,494 |
� |
0.8 |
% |
20,332 |
� |
20,196 |
� |
0.7 |
% |
2,797 |
� |
2,757 |
� |
1.5 |
% |
1,569 |
� |
1,541 |
� |
1.8 |
% |
� |
� |
� |
� |
|
Other revenues |
� |
241 |
� |
267 |
� |
(9.7 |
)% |
195 |
� |
224 |
� |
(12.9 |
)% |
23 |
� |
21 |
� |
9.5 |
% |
23 |
� |
22 |
� |
4.5 |
% |
� |
� |
� |
� |
|
Cost of sales |
� |
(7,988 |
) |
(8,085 |
) |
(1.2 |
)% |
(6,082 |
) |
(6,307 |
) |
(3.6 |
)% |
(1,329 |
) |
(1,275 |
) |
4.2 |
% |
(577 |
) |
(503 |
) |
14.7 |
% |
� |
� |
� |
� |
|
As % of net sales |
� |
(32.4 |
)% |
(33.0 |
)% |
� |
� |
(29.9 |
)% |
(31.2 |
)% |
� |
� |
(47.5 |
)% |
(46.3 |
)% |
� |
� |
(36.8 |
)% |
(32.6 |
)% |
� |
� |
� |
� |
� |
� |
|
Gross profit |
� |
16,951 |
� |
16,676 |
� |
1.6 |
% |
14,445 |
� |
14,113 |
� |
2.4 |
% |
1,491 |
� |
1,503 |
� |
(0.8 |
)% |
1,015 |
� |
1,060 |
� |
(4.2 |
)% |
� |
� |
� |
� |
|
As % of net sales |
� |
68.6 |
% |
68.1 |
% |
� |
� |
71.0 |
% |
69.9 |
% |
� |
� |
53.3 |
% |
54.5 |
% |
� |
� |
64.7 |
% |
68.8 |
% |
� |
� |
� |
� |
� |
� |
|
Research and development expenses |
� |
(3,473 |
) |
(3,524 |
) |
(1.4 |
)% |
(3,012 |
) |
(3,019 |
) |
(0.2 |
)% |
(351 |
) |
(382 |
) |
(8.1 |
)% |
(110 |
) |
(123 |
) |
(10.6 |
)% |
� |
� |
� |
� |
|
As % of net sales |
� |
(14.1 |
)% |
(14.4 |
)% |
� |
� |
(14.8 |
)% |
(14.9 |
)% |
� |
� |
(12.5 |
)% |
(13.9 |
)% |
� |
� |
(7.0 |
)% |
(8.0 |
)% |
� |
� |
� |
� |
� |
� |
|
Selling and general expenses |
� |
(6,526 |
) |
(6,458 |
) |
1.1 |
% |
(5,580 |
) |
(5,507 |
) |
1.3 |
% |
(441 |
) |
(455 |
) |
(3.1 |
)% |
(505 |
) |
(496 |
) |
1.8 |
% |
� |
� |
� |
� |
|
As % of net sales |
� |
(26.4 |
)% |
(26.4 |
)% |
� |
� |
(27.4 |
)% |
(27.3 |
)% |
� |
� |
(15.8 |
)% |
(16.5 |
)% |
� |
� |
(32.2 |
)% |
(32.2 |
)% |
� |
� |
� |
� |
� |
� |
|
Other current operating income/expenses |
� |
68 |
� |
198 |
� |
� |
� |
76 |
� |
163 |
� |
� |
� |
3 |
� |
6 |
� |
� |
� |
18 |
� |
(2 |
) |
� |
� |
(29 |
) |
31 |
� |
|
Share of profit/loss of associates* and joint ventures |
� |
82 |
� |
59 |
� |
� |
� |
55 |
� |
30 |
� |
� |
� |
27 |
� |
32 |
� |
� |
� |
� |
� |
(3 |
) |
� |
� |
� |
� |
� |
� |
|
Net income attributable to non-controlling interests |
� |
(96 |
) |
(122 |
) |
� |
� |
(96 |
) |
(123 |
) |
� |
� |
� |
� |
1 |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Business operating income |
� |
7,006 |
� |
6,829 |
� |
2.6 |
% |
5,888 |
� |
5,657 |
� |
4.1 |
% |
729 |
� |
705 |
� |
3.4 |
% |
418 |
� |
436 |
� |
(4.1 |
)% |
(29 |
) |
31 |
� |
|
As % of net sales |
� |
28.4 |
% |
27.9 |
% |
� |
� |
29.0 |
% |
28.0 |
% |
� |
� |
26.1 |
% |
25.6 |
% |
� |
� |
26.6 |
% |
28.3 |
% |
� |
� |
� |
� |
� |
� |
|
Financial income and expenses |
� |
(309 |
) |
(400 |
) |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Income tax expense |
� |
(1,678 |
) |
(1,557 |
) |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Tax rate** |
� |
25.0 |
% |
24.0 |
% |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Business net income |
� |
5,019 |
� |
4,872 |
� |
3.0 |
% |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
As % of net sales |
� |
20.3 |
% |
19.9 |
% |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Business earnings per share*** (in euros) |
� |
3.81 |
� |
3.68 |
� |
3.5 |
% |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
�
*�� Net of tax.
**� Determined on the basis of Business income before tax, associates and non-controlling interests.
*** Based on an average number of shares outstanding of 1,315.8 million in the first nine months of 2014 and 1,323.8 million in the first nine months of 2013.
(1)�Including impact of transition to IFRIC 21.
�
�
Appendix 3: Reconciliation of Business net income to Net income attributable to equity holders of Sanofi
�
|
� million |
� |
Q3�2014 |
� |
Q3�2013(1) |
� |
Change |
� |
|
Business net income |
� |
1,935 |
� |
1,795 |
� |
7.8 |
% |
|
Amortization of intangible assets(2) |
� |
(561 |
) |
(689 |
) |
� |
� |
|
Impairment of intangible assets |
� |
(35 |
) |
(28 |
) |
� |
� |
|
Fair value remeasurement of contingent consideration liabilities |
� |
(45 |
) |
(68 |
) |
� |
� |
|
Expenses arising from the impact of acquisitions on inventories |
� |
� |
� |
(1 |
) |
� |
� |
|
Restructuring costs |
� |
(163 |
) |
(71 |
) |
� |
� |
|
Additional year expense related to US Branded Prescription Drug Fee(3) |
� |
(116 |
) |
� |
� |
� |
� |
|
Tax effect of items listed above: |
� |
261 |
� |
289 |
� |
� |
� |
|
Amortization of intangible assets |
� |
188 |
� |
233 |
� |
� |
� |
|
Impairment of intangible assets |
� |
13 |
� |
9 |
� |
� |
� |
|
Fair value remeasurement of contingent consideration liabilities |
� |
5 |
� |
23 |
� |
� |
� |
|
Expenses arising from the impact of acquisitions on inventories |
� |
� |
� |
� |
� |
� |
� |
|
Restructuring costs |
� |
55 |
� |
24 |
� |
� |
� |
|
� |
� |
� |
� |
� |
� |
� |
� |
|
Other tax items |
� |
� |
� |
� |
� |
� |
� |
|
� |
� |
� |
� |
� |
� |
� |
� |
|
Share of items listed above attributable to non-controlling interests |
� |
� |
� |
1 |
� |
� |
� |
|
� |
� |
� |
� |
� |
� |
� |
� |
|
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures |
� |
(86 |
) |
(9 |
) |
� |
� |
|
Net income attributable to equity holders of Sanofi |
� |
1,190 |
� |
1,219 |
� |
(2.4 |
)% |
|
Consolidated earnings per share(4)�(in euros) |
� |
0.91 |
� |
0.92 |
� |
� |
� |
�
(1)�������� Including impact of transition to IFRIC 21.
�
(2)�������� Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: �540 million in the third quarter of 2014 and �658 million in the third quarter of 2013.
�
(3)�������� Annual fee related to 2013 sales in the U.S. following the final IRS regulation issued in July�2014 that has changed the timing of liability recognition and leads to a one-time �double� expense in the year of 2014.
�
(4)�������� Based on an average number of shares outstanding of 1,313.0 million in the third quarter of 2014 and 1,323.5 in the third quarter of 2013.
�
See page�12 for comments on the reconciliation of business net income to consolidated net income.
�
�
|
� million |
� |
9M�2014 |
� |
9M�2013(1) |
� |
Change |
� |
|
Business net income |
� |
5,019 |
� |
4,872 |
� |
3.0 |
% |
|
Amortization of intangible assets(2) |
� |
(1,862 |
) |
(2,232 |
) |
� |
� |
|
Impairment of intangible assets |
� |
(109 |
) |
(468 |
) |
� |
� |
|
Fair value remeasurement of contingent consideration liabilities |
� |
(177 |
) |
(185 |
) |
� |
� |
|
Expenses arising from the impact of acquisitions on inventories |
� |
� |
� |
(7 |
) |
� |
� |
|
Restructuring costs |
� |
(298 |
) |
(230 |
) |
� |
� |
|
Other gains and losses, and litigation(3) |
� |
35 |
� |
� |
� |
� |
� |
|
Additional year expense related to US Branded Prescription Drug Fee(4) |
� |
(116 |
) |
� |
� |
� |
� |
|
Tax effect of items listed above: |
� |
783 |
� |
1,038 |
� |
� |
� |
|
Amortization of intangible assets |
� |
639 |
� |
723 |
� |
� |
� |
|
Impairment of intangible assets |
� |
39 |
� |
189 |
� |
� |
� |
|
Fair value remeasurement of contingent consideration liabilities |
� |
19 |
� |
43 |
� |
� |
� |
|
Expenses arising from the impact of acquisitions on inventories |
� |
� |
� |
2 |
� |
� |
� |
|
Other gains and losses, and litigation |
� |
(13 |
) |
� |
� |
� |
� |
|
Restructuring costs |
� |
99 |
� |
81 |
� |
� |
� |
|
� |
� |
� |
� |
� |
� |
� |
� |
|
Other tax items(5) |
� |
(110 |
) |
(109 |
) |
� |
� |
|
� |
� |
� |
� |
� |
� |
� |
� |
|
Share of items listed above attributable to non-controlling interests |
� |
4 |
� |
3 |
� |
� |
� |
|
� |
� |
� |
� |
� |
� |
� |
� |
|
Restructuring costs of associates and joint ventures. and expenses arising from the impact of acquisitions on associates and joint ventures |
� |
(118 |
) |
(26 |
) |
� |
� |
|
Net income attributable to equity holders of Sanofi |
� |
3,051 |
� |
2,656 |
� |
14.9 |
% |
|
Consolidated earnings per share(6)�(in euros) |
� |
2.32 |
� |
2.01 |
� |
� |
� |
�
(1)�������� Including impact of transition to IFRIC 21.
�
(2)�������� Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: �1,798 million� in the first nine months of 2014 and �2,147 million in the first nine months of 2013.
�
(3)�������� Day one profit on Alnylam shares presented in financial result.
�
(4)�������� Annual fee related to 2013 sales following the final IRS regulation issued in July�2014 that has changed the timing of liability recognition and leads to a one-time �double� expense in the year of 2014.
�
(5)�������� Tax on dividends paid to shareholders of� Sanofi.
�
(6)�������� Based on an average number of shares outstanding of 1,315.8 million in the first nine months of 2014 and 1,323.8 million in the first nine months of 2013.
�
�
Appendix 4: Consolidated income statement
�
|
� million |
� |
Q3�2014 |
� |
Q3�2013(1) |
� |
9M�2014 |
� |
9M�2013(1) |
� |
|
Net sales |
� |
8,781 |
� |
8,432 |
� |
24,698 |
� |
24,494 |
� |
|
Other revenues |
� |
87 |
� |
86 |
� |
241 |
� |
267 |
� |
|
Cost of sales |
� |
(2,864 |
) |
(2,871 |
) |
(7,988 |
) |
(8,092 |
) |
|
Gross profit |
� |
6,004 |
� |
5,647 |
� |
16,951 |
� |
16,669 |
� |
|
Research and development expenses |
� |
(1,146 |
) |
(1,182 |
) |
(3,473 |
) |
(3,524 |
) |
|
Selling and general expenses |
� |
(2,309 |
) |
(2,012 |
) |
(6,642 |
) |
(6,458 |
) |
|
Other operating income |
� |
47 |
� |
56 |
� |
163 |
� |
403 |
� |
|
Other operating expenses |
� |
(8 |
) |
(28 |
) |
(95 |
) |
(205 |
) |
|
Amortization of intangible assets |
� |
(561 |
) |
(689 |
) |
(1,862 |
) |
(2,232 |
) |
|
Impairment of intangible assets |
� |
(35 |
) |
(28 |
) |
(109 |
) |
(468 |
) |
|
Fair value remeasurement of contingent consideration liabilities |
� |
(45 |
) |
(68 |
) |
(177 |
) |
(185 |
) |
|
Restructuring costs |
� |
(163 |
) |
(71 |
) |
(298 |
) |
(230 |
) |
|
Operating income |
� |
1,784 |
� |
1,625 |
� |
4,458 |
� |
3,770 |
� |
|
Financial expenses |
� |
(154 |
) |
(147 |
) |
(446 |
) |
(458 |
) |
|
Financial income |
� |
15 |
� |
24 |
� |
172 |
� |
58 |
� |
|
Income before tax and associates and joint ventures |
� |
1,645 |
� |
1,502 |
� |
4,184 |
� |
3,370 |
� |
|
Income tax expense(2) |
� |
(381 |
) |
(277 |
) |
(1,005 |
) |
(628 |
) |
|
Share of profit/loss of associates and joint ventures |
� |
(43 |
) |
29 |
� |
(36 |
) |
33 |
� |
|
Net income |
� |
1,221 |
� |
1,254 |
� |
3,143 |
� |
2,775 |
� |
|
Net income attributable to non-controlling interests |
� |
31 |
� |
35 |
� |
92 |
� |
119 |
� |
|
Net income attributable to equity holders of Sanofi |
� |
1,190 |
� |
1,219 |
� |
3,051 |
� |
2,656 |
� |
|
Average number of shares outstanding (million) |
� |
1,313.0 |
� |
1,323.5 |
� |
1,315.8 |
� |
1,323.8 |
� |
|
Earnings per share (in euros) |
� |
0.91 |
� |
0.92 |
� |
2.32 |
� |
2.01 |
� |
�
(1)�������� Including impact of transition to IFRIC 21.
�
(2)�������� In 2014, including a tax on dividends paid to shareholders of Sanofi: (110) M� compared to (109) M� in 2013.
�
�
Appendix 5: 2014 currency sensitivity
�
Business EPS currency sensitivity
�
����������������� 1% variation in �/$�corresponds to an impact of 0.5% on 2014 Business EPS
����������������� 1% variation in �/Yen corresponds to an impact of 0.1% on 2014 Business EPS
�
Currency exposure on Q3 2014 sales
�
|
Currency |
� |
� |
� | |
|
US $ |
� |
37.3 |
% | |
|
Euro � |
� |
23.1 |
% | |
|
Japanese Yen |
� |
5.5 |
% | |
|
Brazilian Real |
� |
3.5 |
% | |
|
Chinese Yuan |
� |
4.3 |
% | |
|
Russian Ruble |
� |
2.2 |
% | |
|
� |
� |
� |
2.2 |
% |
|
Mexican Peso |
� |
2.0 |
% | |
|
Canadian $ |
� |
1.5 |
% | |
|
Australian $ |
� |
1.6 |
% | |
|
Others |
� |
16.8 |
% | |
�
Currency average rates
�
|
� |
� |
Q3�2013 |
� |
Q3�2014 |
� |
Change |
� |
|
�/$ |
� |
1.32 |
� |
1.33 |
� |
+0.8 |
% |
|
�/Yen |
� |
131.05 |
� |
137.74 |
� |
+5.1 |
% |
|
�/Real |
� |
3.03 |
� |
3.01 |
� |
-0.7 |
% |
|
�/Ruble |
� |
43.45 |
� |
48.08 |
� |
+10.7 |
% |
�
�
�
Appendix 6: R&D Pipeline
�
Registration
�
|
N Toujeo��(U300) |
� |
� PR5i |
|
� |
� |
� |
|
Lemtrada� (alemtuzumab) |
� |
Fluzone��QIV ID |
|
� |
� |
� |
|
N Cerdelga� (eliglustat tartrate) |
� |
� Quadracel� |
�
Phase III
�
|
� LixiLan |
� |
N alirocumab |
� |
� Dengue |
|
� |
� |
� |
� |
� |
|
N Lyxumia��(lixisenatide) |
� |
|
� |
� Clostridium difficile |
|
� |
� |
� |
� |
� |
|
N sarilumab |
� |
� Jevtana��(cabazitaxel) |
� |
|
|
� |
� |
� |
� |
� |
|
N dupilumab |
� |
� SYNVISC-ONE� |
� |
� VaxiGrip��QIV IM |
|
� |
� |
� |
� |
� |
|
N patisiran |
� |
� |
� |
� |
�
Phase II
�
|
� dupilumab |
� |
N SAR391786 |
� |
� Rabies VRVg |
|
� |
� |
� |
� |
� |
|
N valetizumab |
� |
N SAR650984 |
� |
|
|
� |
� |
� |
� |
� |
|
N SAR156597 |
� |
N SAR3419 |
� |
� Tuberculosis |
|
� |
� |
� |
� |
� |
|
N SAR438714 (ALN-TTRsc) |
� |
N Combination |
� |
� |
|
� |
� |
� |
� |
� |
|
� sarilumab |
� |
N Combination |
� |
� |
|
� |
� |
� |
� |
� |
|
N fresolimumab TGF� antagonist Focal segmental glomerulosclerosis |
� |
� |
� |
� |
�
�
Phase I
�
|
N SAR405838 (MI-773) |
� |
N SAR113244 |
� |
N SAR438584 (REGN2222) Respiratory syncytial virus |
|
� |
� |
� |
� |
� |
|
N SAR566658 |
� |
N SAR252067 |
� |
N GZ402665 |
|
� |
� |
� |
� |
� |
|
N SAR125844 |
� |
N SAR228810 |
� |
N GZ402671 |
|
� |
� |
� |
� |
� |
|
N SAR260301 |
� |
N SAR425899 GLP-1 / GCGR agonist Diabetes |
� |
N GZ402666 |
|
� |
� |
� |
� |
� |
|
N SAR307746 |
� |
� SAR342434 |
� |
� Streptococcus pneumonia |
|
� |
� |
� |
� |
� |
|
N SAR245408 (XL147) |
� |
N GZ402663 (sFLT-01) |
� |
� Herpes Simplex Virus Type 2 |
|
� |
� |
� |
� |
� |
|
� Combination |
� |
N StarGen� |
� |
� |
|
� |
� |
� |
� |
� |
|
N SAR408701 |
� |
N UshStat� |
� |
� |
�
N : New molecular entity
�
�
Appendix 7: Expected R&D milestones in Q4 2014 / H1 2015
�
|
Product |
� |
Event |
� |
Timing |
|
� |
� |
� |
� |
� |
|
Dupilumab (anti-IL4R� mAb) |
� |
Start of Phase III trial in Atopic Dermatitis |
� |
Q3 2014 |
|
� |
� |
� |
� |
� |
|
Rotavirus vaccine |
� |
Start of Phase III trial |
� |
Q4 2014 |
|
� |
� |
� |
� |
� |
|
New Insulin Lispro (SAR342434) |
� |
Expected start of Phase III trial in Diabetes |
� |
Q4 2014 |
|
� |
� |
� |
� |
� |
|
Lemtrada� (alemtuzumab) |
� |
Expected U.S. regulatory decision in Multiple Sclerosis |
� |
Q4 2014 |
|
� |
� |
� |
� |
� |
|
Cerdelga� (eliglustat tartrate) |
� |
Expected EU regulatory decision in Gaucher disease |
� |
Q4 2014 |
|
� |
� |
� |
� |
� |
|
Alirocumab (anti-PCSK9 mAb) |
� |
Expected U.S. and EU regulatory submissions in Hypercholesterolemia |
� |
Q4 2014 |
|
� |
� |
� |
� |
� |
|
Fluzone��QIV ID |
� |
Expected U.S. regulatory decision |
� |
Q4 2014 |
|
� |
� |
� |
� |
� |
|
Fluzone��High Dose |
� |
Expected U.S. label upgrade |
� |
Q4 2014 |
|
� |
� |
� |
� |
� |
|
Dupilumab (anti-IL4R� mAb) |
� |
Expected Phase IIb top-line results in Asthma |
� |
Q4 2014 |
|
� |
� |
� |
� |
� |
|
Dengue vaccine |
� |
Expected regulatory submission in priority countries |
� |
Q1 2015 |
|
� |
� |
� |
� |
� |
|
PR5i (DTP-HepB-Polio-Hib) |
� |
Expected EU regulatory submission |
� |
Q1 2015 |
|
� |
� |
� |
� |
� |
|
Quadracel� |
� |
Expected U.S. regulatory decision |
� |
Q1 2015 |
|
� |
� |
� |
� |
� |
|
Toujeo��(U300) |
� |
Expected U.S. regulatory decisions in Diabetes |
� |
Q1 2015 |
|
� |
� |
� |
� |
� |
|
Toujeo��(U300) |
� |
Expected EU regulatory decisions in Diabetes |
� |
Q2 2015 |
|
� |
� |
� |
� |
� |
|
Lyxumia� (lixisenatide) |
� |
Expected ELIXA CV outcome trial top-line results |
� |
Q2 2015 |
�
�
Appendix 8: 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 third quarter and the first nine month of 2014
�
|
��million |
� |
Q3�2014 |
� |
9M�2014 |
� |
|
� |
� |
� |
� |
� |
� |
|
Net sales |
� |
8,781 |
� |
24,698 |
� |
|
� |
� |
� |
� |
� |
� |
|
Effect of exchange rates |
� |
81 |
� |
1,021 |
� |
|
� |
� |
� |
� |
� |
� |
|
Net sales at constant exchange rates |
� |
8,862 |
� |
25,719 |
� |
�
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.
�
Additionally, the business net income was adjusted by the one-time additional yearly expense, unrelated to segment performance and recorded in 2014 on the income statement line selling and general expenses, following the final US IRS regulation related to annual Branded Prescription Drug Fee issued in July 2014.
�
(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.
�
Exhibit 99.2
�
|
PRESS RELEASE |
� |
|
� |
� |
|
|
|
�
Sanofi and Regeneron Announce Start of Phase 3 Study of Dupilumab
in Patients with Atopic Dermatitis
�
TARRYTOWN, N.Y. and PARIS, October�20, 2014 � Sanofi and Regeneron Pharmaceuticals,�Inc. today announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with topical AD medications.
�
LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks. Secondary objectives of the study will evaluate the long-term safety and efficacy of dupilumab up to 52 weeks. The trial will enroll approximately 700 adult patients.
�
�Moderate-to-severe atopic dermatitis is a serious disease characterized by severe itching, sleep disturbances and widespread rash, and existing treatment options have limited efficacy,� said Donald Y. M. Leung, MD,�PhD, a member of the LIBERTY AD Clinical Trials Steering Committee and Head of the Division of Pediatric Allergy and Immunology at National Jewish Health in Denver,�CO. �This Phase 3 program will evaluate if blocking IL-4 and IL-13, two key cytokines in the Th2 inflammatory pathway, may provide a potential new approach for this chronic, difficult-to-manage disease.�
�
The LIBERTY AD Phase 3 clinical program will consist of at least five trials of patients with moderate-to-severe AD at sites worldwide. For more information on the LIBERTY AD CHRONOS study, please visit: http://clinicaltrials.gov/ct2/show/NCT02260986?term=dupilumab&phase=2&rank=2.
�
About the IL-4/IL-13 Pathway and Atopic Dermatitis
�
Moderate-to-severe atopic dermatitis, a serious, chronic form of eczema, is a systemic inflammatory disease characterized by an allergic response driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of this Th2 immune response.
�
Moderate-to-severe forms of atopic dermatitis can be characterized by pronounced pruritus (itch), cutaneous dryness, and skin lesions marked by redness, infiltration/papulation, crusting/oozing, and lichenification (skin thickening), with periods of lesion exacerbation. Intense itching, scratching, and skin damage can lead to secondary infections. Atopic dermatitis is often associated with other inflammatory disorders such as asthma.[1] Moderate-to-severe atopic dermatitis can negatively impact patients� lives and is associated with a high burden to society in terms of direct costs of medical care and prescription drugs and loss of productivity.[2] ,[3] ,[4] ,[5]
�
�
About Dupilumab
�
Dupilumab, a fully-human monoclonal antibody, is directed against the IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-13. Dupilumab was created using Regeneron�s pioneering VelocImmune� technology and is being co- developed with Sanofi in atopic dermatitis, asthma and chronic sinusitis with nasal polyposis. Dupilumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
�
About Sanofi
�
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients� needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
�
About Regeneron
�
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. Several Regeneron programs are based on human genetics findings. For additional information about the company, please visit www.regeneron.com.
�
Sanofi 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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
�
Regeneron Forward-Looking Statements
�
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements.� Words such as �anticipate,� �expect,� �intend,� �plan,� �believe,� �seek,� �estimate,� variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.� These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron�s products, product candidates, and research and clinical programs now underway or planned, including without limitation dupilumab; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron�s product candidates in clinical trials, such as the current and contemplated future clinical trials evaluating dupilumab; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron�s late-stage product candidates, including without limitation dupilumab for
the treatment of chronic sinusitis with nasal polyps; ongoing regulatory obligations and oversight impacting Regeneron�s
�
�
research and clinical programs and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron�s ability to continue to develop or commercialize Regeneron�s products and product candidates; competing drugs and product candidates that may be superior to Regeneron�s products and product candidates; uncertainty of market acceptance and commercial success of Regeneron�s products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron�s agreements with Sanofi and Bayer HealthCare LLC, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto.� A more complete description of these and other material risks can be found in Regeneron�s filings with the United States Securities and Exchange Commission, including its Form�10-K for the year ended December�31, 2013 and its Form�10-Q for the quarter ended June�30, 2014.� The reader is cautioned not to rely on any forward-looking statements made by Regeneron.� Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
�
[1] Bieber T. Mechanisms of disease: atopic dermatitis. N Engl J Med 2008;358:1483-94.
�
[2] Garside R. et al. 2005. The effectiveness and cost-effectiveness of pimecrolimus and tacrolimus for atopic eczema: a systematic review and economic evaluation. Health Technology Assessment. 9(29).
�
[3] Bickers D R. et al. 2006. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. Journal of the American Academy of Dermatology. 5(3):490 - 500.
�
[4] Fowler J F. et al. Direct and indirect cost burden of Atopic Dermatitis: An employer-payer perspective. Managed care interface. 20(10): 26 � 32.
�
[5] Holm E A. et al. 2006. The handicap caused by atopic dermatitis - sick leave and job avoidance. Journal of the� European Academy of Dermatology and Venereology. 20(3):255- 259.
�
|
Contacts Sanofi: |
� |
|
Media Relations |
Investor Relations |
|
Jack Cox |
S�bastien Martel |
|
Tel: +33 (0) 1 53 77 94 74 |
Tel: +33 (0)1 53 77 45 45 |
|
Mobile: +33 (0) 6 78 52 05 36 |
E-mail: [email protected] |
|
E-mail: [email protected] |
� |
|
� |
� |
|
Contacts Regeneron: |
� |
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Media Relations |
Investor Relations |
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Hala Mirza |
Manisha Narasimhan, Ph.D |
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Tel: +1 (914) 847 3422 |
Tel: +1 (914) 847 5126 |
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Exhibit 99.3
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PRESS RELEASE
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Sanofi Pasteur and Immune Design Collaborate on a Vaccine
to Treat Herpes Simplex Virus
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- The two companies will develop a product jointly through phase II -
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Lyon, France - October�16, 2014 - Sanofi Pasteur, the vaccines division of Sanofi and Immune Design Corp., a clinical-stage immunotherapy company, today announced that they have entered into a broad collaboration for the development of a herpes simplex virus (HSV) immune therapy.
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Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including Immune Design�s GLAASTM platform, with the goal to select the best potential immune therapy for patients.
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�We intend to develop the best in class HSV therapeutic vaccine by pooling assets of Sanofi Pasteur and of Immune Design,� explained John Shiver,�PhD, Senior VP for R&D, Sanofi Pasteur. �Given the challenges of vaccine development,� Shiver continued, �collaborations are important to help ensure that the medical need will eventually be met.�
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The two companies will develop the products jointly through Phase II clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase II studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
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About GLAAS
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Immune Design�s GLAAS platform works in vivo and is based on a small synthetic molecule called GLA, which stands for glucopyranosyl lipid adjuvant. GLA selectively binds to the TLR4 receptor and causes potent activation of dendritic cells (DCs) leading to the production of cytokines and chemokines that drive a Th1-type immune response. When GLA is accompanied by an antigen and injected into a patient, the combination is taken up by DCs and leads to the production and expansion of immune cells called CD4 T helper lymphocytes with a Th1 phenotype. These CD4 T cells play a key role in boosting pre-existing cytotoxic T cells that are specific to the same antigen and providing help to other immune cells, including B lymphocytes that are the precursor to antibodies, and natural killer cells that are also important in the overall immune response.
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About Sanofi Pasteur�s HSV Vaccine Program
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Sanofi Pasteur�s HSV vaccine candidate is classified as a replication-defective virus, where the virus possesses all the components of wild-type virus with the exception of two proteins that are involved in viral DNA replication. The vaccine candidate is still capable of infecting cells but does
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not have the necessary machinery to undergo replication and establish latent or long-term infection.� Because of these attributes, the candidate is capable of eliciting a broad immune response, both a B-cell and T-cell response that is directed against the majority of the antigenic components of the virus. The investigative vaccine is currently being studied in a phase I trial sponsored by the U.S. National Institutes of Health (NIH) in people with the infection as well as those without in the United States. Due to the lengthy follow-up of volunteers in the trial, results are expected in 2016. Encouraging preclinical results have been generated by the vaccine candidate where protection against infection has been demonstrated in the guinea pig genital herpes challenge model.
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About HSV
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Herpes is a common sexually transmitted disease (STD) that any sexually active person can acquire. Most people with the virus don�t have symptoms. It is important to know that even without signs of disease, it can still spread to sexual partners. You can get herpes by having vaginal, anal, or oral sex with someone who has the disease. Fluids found in a herpes sore carry the virus, and contact with those fluids can cause infection. You can also get herpes from an infected sex partner who does not have a visible sore or who may not know that he or she is infected, because the virus can be released through your skin and spread the infection to your sex partner(s). Genital herpes is common in the United States, as about one out of every six people aged 14 to 49 years have genital herpes.(1)
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About Sanofi
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Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients� needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company�s heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us
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(1)�http://www.cdc.gov/std/herpes/STDFact-herpes.htm� Accessed September�22, 2014
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Forward Looking Statements
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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
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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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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Contacts:
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Global Media Relations |
Investor Relations |
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Alain Bernal |
S�bastien Martel |
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T. +33-4-37-37-50-38 |
T. +33 1 53 77 45 45 |
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www.sanofipasteur.com |
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U.S. Media Relations
Susan Watkins
T. + 570-957-2563
www.sanofipasteur.com
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Exhibit 99.4
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PRESS RELEASE
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Shantha�s Investigational Rotavirus Vaccine Enters Phase III Clinical Trials in India
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- The live, oral, ready-to-use tetravalent rotavirus vaccine candidate is designed to protect young children from severe diarrhea -
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Lyon, France - October�14, 2014 - Sanofi Pasteur, the vaccines division of Sanofi, announced today the start of a phase III clinical trial in India for its investigational rotavirus vaccine, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad,�India. The trial is designed to show non-inferiority against a currently licensed vaccine with the use of three, ready-to-use liquid doses administered orally, starting from six-to-eight weeks of age, with the subsequent doses administered at 4 weeks intervals.� Close to 1,200 volunteers are being sought at 12 clinical trial sites in India. Shantha�s investigational rotavirus vaccine includes antigens against serotypes G1, G2, G3 and G4.
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A phase I/II study was carried out with the long-term aim to produce a locally licensed vaccine that is safe and able to protect children against rotavirus gastroenteritis. Overall, the results showed that all three doses of the vaccine evaluated in the study were safe, well tolerated and displayed good immunogenicity (dose�response) in healthy Indian infants.(1)
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�We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets, like India, and through partnerships with organizations like Gavi, the Vaccine Alliance�, commented Olivier Charmeil, Sanofi Pasteur�s President�& CEO. � �Sanofi Pasteur wants to be in the position to target a major role in the growing rotavirus market in developing countries, with a key focus on the Gavi market, in public markets for non-Gavi countries, as well as private segments in emerging markets.�
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The World Health Organization (WHO) recommends that vaccination with rotavirus vaccines should be included in all national immunization programs.(2)�Gavi, has established an accelerated vaccine introduction initiative with the objective of driving the sustainable introduction of rotavirus vaccine in 30 Gavi-eligible countries by 2015.(3)�In addition, PATH, an international, non-profit organization to improve public health,�is working to accelerate access to rotavirus vaccines and sustain their implementation and use in countries where children need them most urgently.(4)
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About Rotavirus
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Rotavirus infections, caused mostly by Group A viruses, are prevalent in human populations worldwide. Although the virus can and does infect older individuals, illness caused by rotavirus can be quite severe in infants and young children. In low income countries, the median age at the primary rotavirus infection ranges from 6 to 9 months (80% occur among infants less than 1 year old) whereas in high income countries the first episode may occasionally be delayed until the age of 2�5 years, though the majority still occur in infancy (65% occur among infants less than 1 year old).(1)
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The WHO estimates that in 2008 approximately 453,000 (420,000�494,000) rotavirus gastroenteritis (RVGE)-associated child deaths occurred worldwide. These fatalities accounted for about 5% of all child deaths and a cause-specific mortality rate of 86 deaths per 100,000 population
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aged less than 5 years. About 90% of all rotavirus-associated fatalities occur in low income countries in Africa and Asia and are related to poor healthcare.(1)
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It is estimated that one of every 260 children born each year will die from diarrhea caused by rotavirus infection by their fifth birthday.(2)�Recent studies indicate that rotavirus causes approximately 40% of childhood diarrheal hospitalizations worldwide,(3)�40.7% in Sub Saharan African countries,(4)�33% in Nepal,(5)�34% in Pakistan(6)�,40�50% in Japan,(7)�and around 39% in India in children less than 5 years of age.(8)� India, with more than 1 billion people, 11% of whom are less than 5 years of age, has an especially large population at risk of clinically significant RVGE.(9)
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There is no specific drug approved to cure or ameliorate rotavirus gastroenteritis. Since virtually all infants and young children will suffer at least one rotavirus infection and many will become infected two or more times, even in settings where good hygiene is practiced, universal immunization of infants with a vaccine is clearly the way to reduce rotavirus related morbidity, mortality, and associated medical costs.(1)
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About Shantha�s Rotavirus Vaccine Candidate
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Shantha�s investigational vaccine is designed to prevent severe rotavirus gastroenteritis in infants and children when administered as a 3-dose series to infants between the ages of 6 to 32 weeks Each dose is an all-in-one formulation containing an antacid.� The vaccine is a live-attenuated bovine-human reassortant comprising four serotypes, G1, G2, G3 and G4, and is targeted to be safe, confer non-inferior immunogenicity to already licensed vaccines and have the ability to prevent rotavirus gastroenteritis.
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About Shantha
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Shantha, which was acquired by Sanofi Pasteur Holding in 2009, is a biotechnology pioneer from the emerging countries, founded by Dr.�K I Varaprasad Reddy in 1993 in Hyderabad,�India. Shantha is a fully integrated biotechnology company involved in R&D, manufacturing and marketing.�Shantha�s mission is to develop, produce and market human healthcare products that are affordable and meet the highest International standards. Shantha�s products complement Sanofi Pasteur�s portfolio. Four of its licensed vaccines are WHO-prequalified: Shan5� pediatric vaccine, Shanchol� cholera vaccine, Shanvac-B� hepatitis B vaccine, and ShanTT� tetanus vaccine. Sanofi Pasteur and Shantha are also developing a new pediatric combination vaccine based on Shan5 that will incorporate Sanofi Pasteur�s Inactivated Polio Vaccine (IPV) in order to secure polio eradication.
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About Sanofi
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Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients� needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company�s heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.shanthabiotech.com
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References
(1)�M.S. Dhingra et al. Evaluation of safety and immunogenicity of a live attenuated tetravalent (G1�G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infants. Vaccine 32S (2014) A117�A123
(2)�http://www.who.int/immunization/topics/rotavirus/en/� Accessed 15 Sept 2014
(3)�http://www.gavi.org/support/nvs/rotavirus/� Accessed 15 Sept 2014
(4)�http://sites.path.org/rotavirusvaccine/� Accessed 15 Sept 2014
(5)�WHO. Rotavirus vaccines. WHO position paper - January�2013. Wkly Epidemiol Rec 2013; 88:49�64.
(6)�Tate JE, Burton AH, Pinto CB, Steele AD, Duque J, Parashar UD, et al. 2008 estimate of worldwide rotavirus-associated mortality in children younger than 5years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12:136�41.
(7)�World Health Organization. Global networks for surveillance of rotavirus gastroenteritis, 2001-2008. Wkly Epidemiol Rec 2008; 83:421�5.
(8)�Mwenda JM, Tate JE, Parashar UD, Mihigo R, Ag�cs M, Serhan F, et al. African rotavirus surveillance network. A brief overview.� Pediatr Infect Dis J2014; 33:S6�8.
(9)�Sherchand JB, Nakagomi O, Dove W, Nakagomi T, Yokoo M, Pandey BD, et al. Molecular epidemiology of rotavirus diarrhea among children aged less than 5 years in Nepal: predominance of emergent G12 strains during 2 years. JID2009; 2000(Suppl. 1):S182�7.
(10)�Alam MM, Khurshid A, Shaukat S, Naeema A, Sharifa S, Angeza M, et al. Epidemiology and genetic diversity of rotavirus strains in children with acute gastroenteritis in Lahore, Pakistan. PLoS ONE 2013; 8(6):e67998.
(11) Kamiya H, Nakano T, Kamiya Hi, Yui A, Taniguchi K, Parashar U. Rotavirus associated acute gastroenteritis hospitalizations among Japanese children aged less than 5 years: active rotavirus surveillance in Mie Prefecture, Japan. Jpn J Infect Dis2011; 64:482�7.
(12) Kang G, Arora R, Chitamber SD, Deshpande J, Gupte MD, Kulkarni M. Multicenter, hospital based surveillance of rotavirus disease and strains among Indian children aged less than 5 years. J Infect Dis 2009; 200 (Suppl. 1):S147�53.
(13) Census of India. Govt. of India - Ministry of Home Affairs, Official web-site. Table C-10: population attending educational institution by age, sex, and type of educational institution (Census of India 2001); 2001.Available at: http://www.censusindia.gov.in/Tables Published/C-Series/C-Series�link/c10 india.pdf.� Accessed 15 Sept 2014.
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Forward Looking Statements
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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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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Contacts:
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Global Media Relations |
Investor Relations |
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Alain Bernal |
S�bastien Martel |
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T. +33-4-37-37-50-38 |
T. +33 1 53 77 45 45 |
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www.sanofipasteur.com |
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India Media Relations
Tashif Ayaz
T. +91-40 � 66-30-11-04
www.shanthabiotech.com
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Exhibit 99.5
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PRESS RELEASE
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Sanofi and Regeneron Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps
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Paris and Tarrytown, N.Y. � September�30, 2014 - Sanofi and Regeneron Pharmaceuticals,�Inc. today announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps (CSwNP) who did not respond to intranasal corticosteroids.
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�These data suggest the potential of dupilumab for use in the treatment of another allergic inflammatory condition,� said Gianluca Pirozzi, M.D.,�PhD, Vice President, Global Project Head at Sanofi. �Based on these results, we plan to move forward with further clinical development of dupilumab in patients with chronic sinusitis with nasal polyps, in addition to the ongoing development in atopic dermatitis and in asthma.�
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In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score (NPS), the primary endpoint of the study.� Statistically significant improvements in all secondary efficacy endpoints were also observed, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms (sense of smell, congestion, postnasal drip, runny nose and sleep disturbance). In a pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control. The safety profile was consistent with previous studies. The most common AEs with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
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�There is growing recognition that patients suffering from one type of allergic disease often have additional allergic conditions.� For example, many patients with chronic sinusitis with nasal polyps also have asthma or atopic dermatitis and vice versa,� said Neil Graham, M.D., Vice President, Program Management at Regeneron. �The new data reported today, together with prior Phase 2 data with dupilumab in asthma and atopic dermatitis, support the growing body of scientific evidence that these conditions may result from a core allergic inflammatory process driven by the IL-4/IL-13 pathway.�
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The randomized, double-blind, placebo-controlled study enrolled 60 adult patients with moderate-to-severe CSwNP. Patients in the study received 300 milligrams (mg) of dupilumab or placebo administered once per week (QW) subcutaneously for 16 weeks, following an initial loading dose of 600 mg. All patients in the study also received a standard-of-care nasal corticosteroid spray. Patients were eligible for the study if they continued to have severe CSwNP despite standard treatment for at least one month. Fifty percent of patients in the study had received prior surgery for their condition.
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Asthma was also present in 58 percent of CSwNP patients in the study. The conditions are often co-morbid and symptoms/exacerbations are frequently interdependent.
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Detailed results of the study will be presented at an upcoming medical conference.
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About Dupilumab and IL-4/IL-13 Signaling
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Dupilumab, a fully-human monoclonal antibody, is directed against the IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-13. IL-4 and IL-13 are key cytokines that are required
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for the initiation and maintenance of the Th2 (Type 2 helper T-cell) immune response, which is believed to be a critical pathway in allergic inflammation.
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Dupilumab was created using Regeneron�s pioneering VelocImmune� technology and is being co-developed with Sanofi in atopic dermatitis, asthma and CSwNP. Dupilumab is an investigational agent under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
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About Chronic Sinusitis with Nasal Polyps
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CSwNP causes mucosal inflammation and polyps in the nasal cavity and sinuses, which result in long-term symptoms of nasal obstruction and congestion, reduction in or loss of sense of smell, and facial pain. Nasal polyps can block normal drainage from the sinuses and patients with nasal obstruction related to nasal polyposis have a 2-fold higher risk of sleep dysfunction. About 75 percent of CSwNP patients have a decreased sense of smell. The estimated prevalence of CSwNP is 3% to 5% (in Europe and US), and many patients do not respond to the only currently available therapy (intranasal corticosteroids). In the U.S., approximately 200,000 CSwNP patients have sinus surgery to improve breathing, nasal drainage and remove inflamed mucosal tissue. CSwNP is often associated with asthma.� Approximately 30% of patients with CSwNP have asthma.
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About Sanofi
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Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients� needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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About Regeneron
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Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. For additional information about the company, please visit www.regeneron.com.
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Regeneron Forward-Looking Statements
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This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements.� Words such as �anticipate,� �expect,� �intend,� �plan,� �believe,� �seek,� �estimate,� variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.� These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron�s products, product candidates, and research and clinical programs now underway or planned, including without limitation dupilumab; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron�s product candidates in clinical trials, such as the current and contemplated future clinical trials evaluating dupilumab; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron�s late-stage product candidates, including without limitation dupilumab for the treatment of chronic sinusitis with nasal polyps; ongoing regulatory obligations and oversight impacting Regeneron�s research and clinical programs and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron�s ability to continue to develop or commercialize Regeneron�s products and product candidates; competing drugs and product candidates that may be superior to Regeneron�s products and product candidates; uncertainty of market acceptance and commercial success of Regeneron�s products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron�s agreements with Sanofi and Bayer HealthCare LLC, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto.� A more complete description of these and other material risks can be found in Regeneron�s filings with the United States Securities and Exchange Commission, including its Form�10-K for the year ended December�31, 2013 and its Form�10-Q for the quarter
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ended June�30, 2014.� The reader is cautioned not to rely on any forward-looking statements made by Regeneron.� Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
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Sanofi Forward-Looking Statements
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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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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Sanofi Contacts:
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Media Relations Jack Cox Tel.�: +33 (0)1 53 77 46 46 |
Investor Relations S�bastien Martel Tel.: +33 (0)1 53 77 45 45 |
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Regeneron Contacts: |
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Media Relations Hala Mirza Tel.�+1 (914) 847-3422 |
Investor Relations Manisha Narasimhan, Ph.D. Tel. +1 (914) 847-5126 |
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Exhibit 99.6
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PRESS RELEASE
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Sanofi and MyoKardia Announce Groundbreaking Collaboration to
Develop Targeted Therapies for Patients with Genetic Heart Disease
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- Up to $200 Million Collaboration to Support Pioneering Science and New Treatments -
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Paris and South San Francisco, CA - September�17, 2014 - Sanofi (EURONEXT: SAN and NYSE:�SNY) and MyoKardia,�Inc., a privately-held company leading the development of precision therapies for genetic heart disease, announced today a worldwide collaboration to discover and develop first-of-its-kind targeted therapeutics for heritable heart diseases known as cardiomyopathies, the most common forms of heart muscle disease. The collaboration builds upon MyoKardia�s pioneering science, which hopes to correct the disruptive effects that disease mutations have on heart muscle contraction.
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The collaboration, representing one of the largest research and development commitments to genetic forms of cardiomyopathy, encompasses three MyoKardia programs. Two of these programs are focused on hypertrophic cardiomyopathy (HCM) and the other is focused on dilated cardiomyopathy (DCM). The collaboration provides up to $200 million in equity investments, milestone payments and research and development services through 2018, of which $45 million has already been received in an upfront licensing fee and an initial equity investment. In addition, Sanofi and MyoKardia will equally share development costs on the HCM programs following initial demonstration of efficacy in patients, with Sanofi fully covering the development costs of the DCM program.
�
The collaboration is an outgrowth of Sanofi�s Sunrise initiative, a strategic partnership model that seeks to invest in early stage opportunities that align with Sanofi�s expert development and commercialization abilities. The commitment of resources from Sanofi will accelerate and broaden MyoKardia�s basic disease research and will support the shared commitment of bringing desperately needed therapies to patients.
�
�This collaboration illustrates Sanofi�s research and development philosophy for Sunrise projects. It combines in a meaningful way the unique expertise in rare and cardiovascular diseases of our top scientists with that of the best innovators in the world, like MyoKardia�s founders and scientists, to achieve real breakthroughs in medicine,� said Dr.�Elias Zerhouni, President Global R&D for Sanofi.
�
�MyoKardia�s research represents the first hope for targeted treatments that address the primary cause of each patient�s disease,� said Tassos Gianakakos, Chief Executive Officer, MyoKardia. �By genetically defining HCM and DCM into several underlying rare genetic diseases, MyoKardia�s candidate therapies have the potential to be developed far more efficiently than traditional cardiovascular drugs. The collaboration extends MyoKardia�s competitive advantage, allowing advancement of a broad portfolio of important treatments for patients�.
�
Within the collaboration, MyoKardia will drive research and worldwide development activities through early human efficacy studies. Thereafter, MyoKardia will lead worldwide development and U.S. commercial activities for the two HCM programs, where it has retained product rights, and Sanofi will lead global development and commercial activities for DCM where it has obtained worldwide rights, and ex-U.S. regulatory and commercial activities to the two HCM programs where it has ex-U.S. commercialization rights. Sanofi also has the option to co-promote in the U.S. for potential expanded cardiovascular diseases outside of the genetically targeted indications for either
�
�
of the HCM programs, with MyoKardia having the option to co-promote the DCM program in the U.S.
�
�We are very excited to embark on this deep collaboration with MyoKardia, to identify first-in-class, life-changing therapies for HCM and DCM patients,� said Dr.�Kathy Bowdish, Vice President Global R&D and Head of Sunrise. �This opportunity allows us to advance our collective knowledge and bench strength in this exciting and emerging field. This creative collaboration truly demonstrates Sanofi�s open innovation model.�
�
About Genetic Cardiomyopathies
�
HCM and DCM are types of heritable heart diseases that are caused by mutations in the genes of the proteins that are primarily responsible for the contraction of the heart muscle. HCM is the leading cause of sudden cardiac death in young adults, and DCM, the leading genetic illness requiring heart transplantation, together are believed to affect nearly 800,000 children and adults in the U.S. alone. Available treatments for patients suffering from these forms of heart disease have been approved for other illnesses and only treat the symptoms of their disease. As their disease progresses, it can require invasive procedures including heart transplantation, and can lead to sudden cardiac death and complications associated with heart failure, including stroke.
�
HCM is believed to be the most common heritable cardiovascular disease, thought to affect one in 500 people in the general population. HCM is characterized by an abnormal thickening and stiffening of the walls of the heart�s main pumping chamber, the left ventricle. Disease-causing HCM mutations make it difficult for the heart to relax and refill with fresh blood between beats, causing shortness of breath and sometimes dizziness, fainting or chest pain. About one-fourth of HCM patients experience an abnormal heart rhythm called atrial fibrillation that profoundly increases the risk of potentially debilitating or even fatal stroke.
�
Genetically-defined DCM, estimated to occur in one in 2,500 people in the general population, is a condition in which the heart becomes enlarged and weakened, and is unable to pump enough blood to the rest of the body. DCM is also known to be associated with harmful blood clots, which can cause strokes, and with irregular and harmful heartbeats and sudden cardiac death. More than 20 percent of heart transplantations are performed every year for patients with genetic DCM.
�
About Sanofi
�
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients� needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, and consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
�
To learn more about Sunrise, please visit www.sanofi-sunrise.com
�
About MyoKardia
�
MyoKardia,�Inc. is pioneering a precision medicine approach to treat patients with genetic heart disease. By combining leading-edge cardiovascular genetics with recent advances in heart muscle biochemistry, MyoKardia seeks to make a meaningful difference in the lives of people suffering from these diseases. Leveraging powerful genetic insights MyoKardia intends to classify these heritable cardiovascular diseases into a series of underlying rare genetic disorders, enabling physicians to treat patients based on their unique genetic and clinical profiles. MyoKardia has helped organize an international patient registry, the Sarcomeric Human Cardiomyopathy Registry (SHaRe) to help in this effort. As a result, MyoKardia�s therapeutic candidates have the potential to be developed far more efficiently than traditional cardiovascular drugs � matching the appropriate therapy to each patient Launched in 2012, MyoKardia was founded by world-class experts in cardiovascular disease, cardiac muscle biology and genetics, and is funded by leading healthcare investor Third Rock Ventures. For more information, please visit www.myokardia.com.
�
�
Sanofi 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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
�
Contacts Sanofi�:
�
|
Media Relations Laurence Bollack Tel: +33 (0) 1 53 77 46 46 E-mail: [email protected] � Global R&D Communications Amy Ba, Ph. D. T�l: +1 617-665-4851 E-mail: [email protected] |
� |
Investor Relations Sebastien Martel Tel: +33 (0)1 53 77 45 45 E-mail: [email protected] � |
�
Contacts MyoKardia�:
�
|
Sheryl Seapy Pure Communications T�l. : 949-903-4750 |
� |
�
Exhibit�99.7
�
PRESS RELEASE
�
|
|
|
�
At Four Years, Treatment Effect Maintained in More Than Two-Thirds
of Patients Who Received Genzyme�s Lemtrada in Pivotal Studies
�
- In approximately 70 percent of patients, disability scores improved or remained stable for
an additional two years beyond the two-year pivotal multiple sclerosis studies -
�
- Approximately 70 percent of patients treated with Lemtrada did not receive
a third course of treatment through the second year of the extension �
�
Paris � September�11, 2014 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today positive interim results from the second year of the extension study of Lemtrada� (alemtuzumab) for multiple sclerosis.
�
In this analysis, relapse rates and sustained accumulation of disability remained low among patients who had previously received Lemtrada in either of the Phase III CARE-MS I and CARE-MS II studies. In these pivotal studies, Lemtrada was given as two annual courses, at the start of the study and 12 months later. Approximately 70 percent of patients who received Lemtrada in the pivotal studies did not receive further treatment with Lemtrada through the second year of the extension study. No new safety signals were identified. These data will be presented today at the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) meeting in Boston.
�
�These extension study results provide further evidence of the prolonged efficacy of Lemtrada on both relapses and disability,� said Dr.�Alasdair Coles, Senior Lecturer, Department of Clinical Neurosciences, University of Cambridge.� �The majority of patients continued to experience reduced disease activity, even though their last Lemtrada treatment was three years earlier.�
�
Extension Study Results
�
The Phase III trials of Lemtrada were randomized, two-year pivotal studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif�) in patients with relapsing-remitting multiple sclerosis who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).
�
More than 90 percent of the patients who were treated with Lemtrada in the Phase III trials enrolled in the extension study.� These patients were eligible to receive additional treatment with Lemtrada in the extension study if they experienced at least one relapse or at least two new or enlarging brain or spinal cord lesions.
�
The following interim results are from the second year of the extension study for patients who previously received Lemtrada in the two-year pivotal studies:
�
������������������ In year four, the annualized relapse rates for patients who received Lemtrada in CARE-MS I and CARE-MS II were 0.14 and 0.23, respectively. These rates were comparable to the annualized relapse rates for those patients who received Lemtrada in the pivotal trials.
�
������������������ Through year four, 74 percent of patients in CARE-MS I and 66 percent in CARE-MS II had improved or stable disability as measured by the Expanded Disability Status Scale (EDSS).
�
�
������������������ Through year four, 83 percent and 76 percent of patients who received Lemtrada in the pivotal trials, respectively, did not experience six-month sustained accumulation of disability � meaning they did not experience a worsening of their disability that persisted for six continuous months in the four years of observation.
�
������������������ Approximately 70 percent of patients treated with Lemtrada in the pivotal studies did not receive a third course of treatment in years three and four.
�
�MS is a devastating disease and patients remain in need of new treatment options that may offer greater efficacy. These new data reinforce the transformative potential of Lemtrada,� said Genzyme President and CEO, David Meeker, M.D. �It is encouraging to see the durable efficacy and manageable safety of Lemtrada maintained two years into the extension study.�
�
Safety results from the second year of the extension study were reported. No new risks were identified. As previously reported, there were two deaths in the extension study. One was from sepsis and the other was presumed accidental and deemed unrelated to study treatment. Over four years, approximately 2 percent of patients treated with Lemtrada in the pivotal trials developed immune thrombocytopenia (ITP), all of whom responded to treatment.� Patient monitoring for autoimmune disorders is incorporated in all Genzyme-sponsored trials of Lemtrada.
�
The most common side effects of Lemtrada are infusion associated reactions (headache, rash, pyrexia, nausea, fatigue, urticaria, insomnia, pruritus, diarrhea, chills, dizziness, and flushing), infections (upper respiratory tract and urinary tract), and thyroid disorders. Autoimmune conditions (including immune thrombocytopenia, other cytopenias, glomerulonephritis and thyroid disease) and serious infections can occur in patients receiving Lemtrada. A comprehensive risk management program incorporating education and monitoring will help support early detection and management of these identified risks.
�
About CARE-MS
�
The Lemtrada clinical development program included two randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif�) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study.� In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.
�
About LemtradaTM�(alemtuzumab)
�
Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up.� Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
�
Lemtrada is approved in the European Union, Australia, Canada, Mexico, Brazil, Argentina, Chile and Guatemala. �Lemtrada is currently not approved in the United States.� The U.S. Food and Drug Administration (FDA) has accepted for review the company�s resubmission of its application seeking approval of Lemtrada, and Genzyme expects FDA action on the application in the fourth quarter.� Marketing applications for Lemtrada are also under review in other countries.
�
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the
�
�
onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.
�
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive contingent payments based on global sales revenue.
�
About Genzyme, a Sanofi Company
�
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme�s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world�s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
�
Genzyme��is a registered trademark and LemtradaTM�is a trademark of Genzyme Corporation.� Rebif��is a registered trademark of EMD Serono,�Inc.
�
About Sanofi
�
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients� needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
�
Sanofi 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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
�
Contacts:
�
|
Media Relations Jack Cox Tel.�: +33 (0)1 53 77 46 46 |
� |
Investor Relations S�bastien Martel Tel.: +33 (0)1 53 77 45 45 |
� |
Genzyme Media Relations Erin Pascal Tel: + 1 617 768 6864 |
�
Exhibit 99.8
�
PRODUCT SALES STATEMENT, FOR THE PRODUCT SALES MEASURING PERIOD ENDED SEPTEMBER 30, 2014
�
As called for under �5.4 of the Contingent Value Rights Agreement by and between Sanofi (formerly known as sanofi-aventis) and American Stock Transfer�& Trust Company LLC dated as of March�30, 2011.� All capitalized terms used in the present Product Sales Statement have the respective meanings ascribed to them therein. Amounts set forth herein are not necessarily indicative of results that will be achieved in subsequent Product Sales Measuring Periods.
�
Sales data to be provided prior to fulfilment of Product Sales Milestone #1:
�
For the Product
�
|
� |
� |
Q3�2014 |
� |
Q2�2014 |
� |
Q1�2014 |
� |
Q4�2013 |
� | ||||||||||||||||
|
Market |
� |
(I) |
� |
(II) |
� |
X- rate |
� |
(I) |
� |
(II) |
� |
X- rate |
� |
(I) |
� |
(II) |
� |
X- rate |
� |
(I) |
� |
(II) |
� |
X- rate |
� |
|
Major Markets |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
USA |
� |
� |
� |
� |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
|
UK |
� |
0.9 |
� |
0.8 |
� |
0.599 |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
|
France |
� |
� |
� |
� |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
|
Germany |
� |
4.8 |
� |
4.4 |
� |
0.755 |
� |
6.1 |
� |
5.7 |
� |
0.729 |
� |
4.7 |
� |
4.3 |
� |
0.730 |
� |
2.0 |
� |
1.7 |
� |
0.735 |
� |
|
Italy |
� |
� |
� |
� |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
|
Spain |
� |
� |
� |
� |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
|
Subtotal |
� |
5.7 |
� |
5.2 |
� |
� |
� |
6.1 |
� |
5.7 |
� |
� |
� |
4.7 |
� |
4.3 |
� |
� |
� |
2.0 |
� |
1.7 |
� |
� |
� |
|
All other� |
� |
4.5 |
� |
4.4 |
� |
Misc. |
� |
2.9 |
� |
2.7 |
� |
Misc. |
� |
2.3 |
� |
2.2 |
� |
Misc. |
� |
0.7 |
� |
0.6 |
� |
Misc. |
� |
|
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Exclusions |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
� |
|
Oncology(1) |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
0 |
� |
0 |
� |
� |
� |
|
Transplant Indications* |
� |
** |
� |
** |
� |
� |
� |
1.1(2) |
� |
N/A |
� |
� |
� |
1.2 |
� |
N/A |
� |
� |
� |
1.3 |
� |
N/A |
� |
� |
� |
�
Legend:
�
|
(I): |
Aggregate gross amount invoiced by the Company, its Affiliates and its licensees for sales of the Product by the Company, its Affiliates and licensees of the Company and its Affiliates to third parties, in millions of United States dollars. |
|
(II): |
Product Sales, in millions of United States dollars. |
|
X-rate: |
Exchange rates used for conversion of the specified Major Market�s foreign currency into United States dollars for the quarter indicated. Exchange rates for other markets will be provided to the extent there are sales invoiced in currencies other than the United States dollar. |
|
*: |
Note that amounts appearing in this line are a subset of the amounts appearing in the �Oncology� line, above, provided for information purposes and calculated by reference to relevant data compiled by the UNOS (United Network for Organ Sharing). |
|
**: |
During the period under review, there were no Transplant Indication stock keeping units (SKUs) recorded. UNOS data specifying Transplant Indication usage for the specified period is not available as of the date of this Statement. |
|
N/A: |
Not applicable. |
|
(1): |
The Company is in the process of ceasing the commercialization of Campath��on a global basis. In the countries where the sales have ceased, Campath��is being made available to patients at no cost through a patient access/distribution program. Previously sold product amounting to 0.3 million of United States dollars were returned to the Company during the quarter. |
|
(2): |
Preliminary figure. |
�
Do Product Sales in the Product Sales Measuring Period ended September�30, 2014 include Product Sales of a Combination Product? x No� o Yes
�
�
Has any Product Sales Milestone been achieved during the Product Sales Measuring Period ended September�30, 2014? x No o Yes
�
After due inquiry and to the best of the knowledge and belief of the undersigned, the undersigned hereby certifies that the information set forth in this statement is true, complete and correct.
�
�
|
� |
Sanofi | |
|
� |
� | |
|
� |
By: |
/s/ J�r�me Contamine |
|
� |
Name: |
J�r�me Contamine |
|
� |
Title: |
Executive Vice President, Chief Financial Officer |
|
� |
� |
� |
|
� |
Date: |
October�28, 2014 |
�






