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PRESS RELEASE Paris

Key Takeaway: Sanofi delivered 2015 business EPS up 8.5% on a reported basis and stable at constant exchange rates consistent with guidance Executing on 2020 strategic roadmap Recent achievements in advancing Sanofi s R&D pipeline of innovative medicines growth in Pharmaceuticals, Vaccines

Full Press Release Details

Sanofi delivered 2015 business EPS up 8.5% on a reported basis
and stable at constant exchange rates consistent with guidance
Executing on 2020 strategic roadmap
Recent achievements in advancing Sanofi s R&D pipeline of innovative medicines
growth in Pharmaceuticals, Vaccines and Animal Health in 2015
financial results in 2015 while making significant investments in new product launches
2016 financial guidance
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
In 2015, Sanofi made meaningful progress with key launches, multiple business development activities and our efforts to simplify the organization.
Entering into exclusive negotiations on a business swap with Boehringer Ingelheim would bring us leadership in CHC. This is a key first step in reshaping our portfolio. In 2016, we continue to allocate resources to our promising late-stage pipeline
and the introduction of innovative medicines which will position us for accelerated future growth .
Q4 2015 Change Change (CER) 2015 Change Change (CER)
Aggregate Group sales (2) 9,278m +2.3 % -1.6 % 37,057m +9.7 % +2.2 %
Business net income (1) 1,709m -6.5 % -13.5 % 7,371m +7.7 % -0.9 %
Business EPS (1) 1.31 -5.8 % -12.9 % 5.64 +8.5 % 0.0 %
IFRS net sales reported 8,719m +1.8 % -2.0 % 34,542m +9.0 % +1.6 %
IFRS net income reported 334m -75.1 % 4,287m -2.3 %
IFRS EPS reported 0.26 -74.5 % 3.28 -1.8 %
Following the announcement of exclusive negotiations with Boehringer Ingelheim and as the IFRS 5 presentation requirement
for discontinued operations, net income for Sanofi s Animal Health business (Merial) will be reported on a separate line ( net income from the held for exchange Animal Health Business ) in the Consolidated Income Statement for 2015
and the prior year. Until the closing of the transaction, Sanofi will continue to manage and report the performance of the Animal Health business, which will remain an operating segment consistent with IFRS 8 and be included in the key performance
indicators of the Group.
Investor Relations: (+) 33 1 53 77 45 45 - E-mail: IR@sanofi.com - Media
Relations: (+) 33 1 53 77 46 46 - E-mail: MR@sanofi.com
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2015 fourth-quarter and full-year Aggregate Group sales
Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(1).
Fourth-quarter Aggregate Group sales were 9,278 million up 2.3% at 2015 exchange rates. Exchange rate movements had a positive effect of 3.9
percentage points reflecting mainly the strength of the U.S. dollar against the Euro, which largely offset the negative effect of the Brazilian real and the Russian Ruble. At CER, Aggregate Group sales decreased 1.6%. This includes the impact of the
voluntary recall of Auvi-Q /Allerject in the U.S. and Canada announced on October 30. The negative impact of the recall on sales was
- 122 million which corresponded mainly to the reversal of sales of the product since the beginning of 2015. Excluding
AuviQ /Allerject , Aggregate Group sales were down 0.3% at CER.
In 2015, Aggregate Group sales were 37,057 million, up 9.7% at 2015 exchange rates. Exchange rate movements had a favorable effect of 7.5 percentage
points resulting in an increase of aggregate Group sales of 2.2% at CER.
million Q4 2015 Change (CER) 2015 Change (CER)
Pharmaceuticals 7,277 -4.7 % 29,799 +0.8 %
Diabetes 1,903 -12.6 % 7,580 -6.8 %
Genzyme 1,013 +28.2 % 3,664 +29.5 %
Consumer Healthcare (CHC) 809 +1.0 % 3,492 +2.8 %
Generics 467 +4.7 % 1,917 +7.6 %
Oncology 381 -7.9 % 1,504 -1.9 %
Established Rx Products 2,699 -10.4 % 11,633 -2.3 %
Vaccines 1,442 +15.0 % 4,743 +7.3 %
Animal Health 559 +5.9 % 2,515 +10.8 %
Total Aggregate Group sales 9,278 -1.6 % 37,057 +2.2 %
Fourth-quarter sales for Pharmaceuticals decreased 4.7% to 7,277 million impacted by a decline in Diabetes and Established Rx Products that was partially
offset by Genzyme. Excluding AuviQ /Allerject , sales for Pharmaceuticals were down 3.2%. In 2015, sales for Pharmaceuticals increased
0.8% to 29,799 million.
million Q4 2015 net sales Change (CER) 2015 net sales Change (CER)
Lantus 1,536 -19.9 % 6,390 -10.8 %
Amaryl 94 0.0 % 393 +1.7 %
Apidra 104 +3.1 % 376 +4.8 %
Toujeo 98 164
Insuman 38 0.0 % 141 +2.9 %
BGM (Blood Glucose Monitoring) 16 -11.1 % 63 -1.6 %
Lyxumia 11 +25.0 % 38 +37.0 %
Afrezza 2 7
Total Diabetes 1,903 -12.6 % 7,580 -6.8 %
In the fourth quarter, sales of Diabetes decreased 12.6% to 1,903 million, reflecting lower sales of Lantus in the U.S. In 2015, sales of Diabetes were 7,580 million, down 6.8% and in line with the guidance communicated in October.
In the U.S., fourth-quarter sales of Diabetes were down 25.1% to 1,056 million. Sales of Diabetes outside
the U.S. were 847 million, an increase of 7.0% supported by the strong performance in Emerging Markets up 15.1% to 426 million. Sales in Western Europe reached 302 million, up 1.0% reflecting glargine biosimilar competition.
Toujeo , the new-generation basal insulin, was launched in the U.S. market at the end of March
and later in the year in other key global markets. Total sales of the product were 98 million in the fourth quarter compared to 46 million in the third quarter of 2015. In the U.S. sales of Toujeo were 79 million reflecting strong adoption by prescribers supported by rapid and broad commercial and Medicare market access.
Toujeo is now available globally in more than 20 countries and generated full year 2015 sales of 164 million including 27 million outside the U.S.
Fourth-quarter sales of Sanofi s glargine franchise (Lantus and Toujeo ) were 1,634 million, down 14.9%. Over the quarter, sales of Lantus were 1,536 million down 19.9%. In the U.S., as
anticipated, sales of Lantus decreased 31.6% to 933 million mainly reflecting higher discounts as compared to last year, a slowdown of basal insulin market growth and an unfavorable mix
effect towards highly-discounted government channels such as Medicaid (which also included Medicaid delayed bills from multiple States). In Western Europe, sales of Sanofi s glargine franchise were up 0.4% to 231 million reflecting the
launch of a biosimilar glargine in the second half of 2015 in several European markets. In Emerging Markets, fourth-quarter sales of Sanofi s glargine franchise were 304 million, up 17.2%, driven by Lantus in China, Middle East, Russia and Turkey. In 2015 sales of Sanofi s glargine franchise were 6,554 million, down 8.5%.
Fourth-quarter sales of Amaryl were stable at 94 million, of which 76 million
were generated in Emerging Markets (up 4.2%). In 2015, Amaryl sales were up 1.7% to 393 million. Fourth-quarter sales of
Apidra increased 3.1% to 104 million, reflecting lower sales in the U.S. (-12.2% to 42 million). In Emerging Markets, sales of Apidra increased 19.0% to 24 million. In 2015, sales of Apidra were up 4.8% to 376 million.
Afrezza sales were 2 million and 7 million in the fourth quarter and 2015,
respectively. On January 4, 2016, Sanofi informed MannKind Corporation, that it has exercised its option to terminate its agreement. This termination will become effective on April 4, 2016. This action is in line with the terms of the contract, and
the decision to terminate is due to a number of factors, including the continued low level of prescriptions for Afrezza despite Sanofi s substantial efforts. Sanofi intends to work with
MannKind to support a smooth transition and will continue to make Afrezza available in the United States for a period of up to approximately 180 days after the date of Termination, as set
forth in the License and Collaboration Agreement.
Following European approval in September 2015, Praluent (alirocumab, collaboration with
Regeneron) was launched in the UK, Germany and Nordic countries in the fourth quarter. In the U.S., Praluent was launched in July and is now accessible on formularies covering over 170
million lives in the U.S. In addition to the significant market access achieved, Praluent is the only PCSK9 inhibitor preferred across UnitedHealth Group formularies. Worldwide sales of
Praluent were 5 million and 9 million in the fourth quarter and full year of 2015, respectively.
million Q4 2015 net sales Change (CER) 2015 net sales Change (CER)
Cerezyme 180 -9.6 % 757 +1.3 %
Myozyme / Lumizyme 167 +6.7 % 650 +12.4 %
Fabrazyme 158 +20.3 % 592 +17.2 %
Aldurazyme 49 +6.7 % 195 +8.7 %
Cerdelga 22 66
Total Rare Diseases 660 +8.4 % 2,550 +11.4 %
Aubagio 272 +69.9 % 871 +77.8 %
Lemtrada 81 243
Total Multiple Sclerosis 353 +99.4 % 1,114 +112.2 %
Total Genzyme 1,013 +28.2 % 3,664 +29.5 %
Fourth-quarter sales of Genzyme increased 28.2% to 1,013 million driven by Aubagio and the launch progress of Lemtrada . Genzyme delivered strong performance across all geographies with the U.S. up 42.1% to 485
million and Western Europe up 25.3% to 290 million over the period. In Emerging Markets, sales were 148 million, up 9.7% in the fourth quarter. In 2015, sales of Genzyme increased 29.5% to 3,664 million.
Sales of Multiple Sclerosis products increased 99.4% to 353 million in the fourth quarter. In 2015,
sales of this franchise grew 112.2% exceeding 1 billion in annual sales for the first time ( 1,114 million).
Fourth-quarter sales of
Aubagio were up 69.9% to 272 million driven by the U.S. (up 57.4% to 194 million) and Western Europe ( 58 million in sales). In Western Europe, Aubagio exceeded 15% market share in France and some Nordic countries. In 2015, sales of Aubagio increased 77.8% to 871 million.
Fourth-quarter sales of Lemtrada were 81 million including 44 million in the U.S.
and 28 million in Western Europe, mainly in Germany and the UK. In 2015, sales of Lemtrada were 243 million compared to 34 million in 2014.
Sales of Rare Disease products were up 8.4% to 660 million in the fourth quarter and 11.4% to 2,550 million in 2015.
Sales of the Gaucher franchise reached 202 million in the fourth quarter, down 1.5% and reflecting lower sales in Emerging markets of Cerezyme ( 59 million, down 14.7%) due to lower Russian government purchasing. In the U.S., fourth-quarter sales of the Gaucher franchise increased 11.5% to 66 million reflecting decreased
sales of Cerezyme ( 47 million, down 12.5%) which were more than offset by Cerdelga sales ( 19 million versus 4
million in Q4 2014), the only first-line oral therapy for Gaucher disease type 1 patients. In Western Europe, where Cerdelga is now available in several countries (Germany, France, Denmark,
Norway and Sweden), sales of the Gaucher franchise were 64 million, up 3.2%. In 2015, sales of the Gaucher franchise increased 8.6% to 823 million, mainly reflecting new patient accrual by Cerdelga .
Fourth-quarter sales of Fabrazyme
increased 20.3% to 158 million. The product recorded strong performance in the U.S. (up 20.3% to 82 million), Western Europe (up 17.2% to 35 million), and Emerging Markets (up 46.7% to 19 million) reflecting new patient
accrual. In 2015, sales of Fabrazyme increased 17.2% to 592 million.
Myozyme /Lumizyme were 167 million, an increase of 6.7% in the fourth quarter, driven by the U.S. (up 9.3% to
55 million) and Emerging markets (up 11.5% to 28 million). In Western Europe, sales were stable at 72 million. In 2015, sales of Myozyme /Lumizyme were 650 million, an increase of 12.4%.
million Q4 2015 net sales Change (CER) 2015 net sales Change (CER)
Allegra 75 -5.4 % 424 +8.0 %
Doliprane 83 +6.4 % 303 -2.3 %
Essentiale 55 +1.6 % 196 -6.4 %
Enterogermina 35 +5.9 % 161 +1.3 %
Nasacort 21 -17.4 % 122 -8.8 %
Lactacyd 20 -4.3 % 114 +10.6 %
Maalox 22 -8.0 % 97 +4.1 %
No Spa 22 -4.0 % 88 -5.5 %
Magne B6 20 +9.1 % 82 +9.1 %
Dorflex 17 +4.5 % 81 +6.7 %
Other CHC Products 439 +2.1 % 1,824 +4.2 %
Total Consumer Healthcare 809 +1.0 % 3,492 +2.8 %
Sales of Consumer Healthcare (CHC) products were 809 million in the fourth quarter, an increase of 1.0% driven by
higher sales in Australia and Mexico. Over the quarter, sales of CHC in the U.S. were up 0.6% to 197 million reflecting lower sales of Nasacort compared to strong sales following the
product launch in 2014. Fourth-quarter sales of CHC in Emerging Markets were stable at 392 million, with lower sales in Venezuela offsetting the recovery in Mexico. In Western Europe, sales were flat at 159 million in the quarter,
impacted by a second price decrease of Doliprane in France in November. In the Rest of the World, fourth-quarter sales grew 12.5% to 61 million driven by Australia. In 2015, sales of
CHC reached 3,492 million, an increase of 2.8%.
Fourth-quarter sales of Generics increased 4.7% to 467 million driven by sales in Western Europe (up 9.8% to 150 million) and sales of
authorized generics version of Lovenox in the U.S. and Plavix in Japan. In Emerging Markets, fourth-quarter sales of Generics were
258 million, down 1.0% reflecting lower sales in Brazil. In 2015, sales of Generics increased 7.6% to 1,917 million.
million Q4 2015 net sales Change (CER) 2015 net sales Change (CER)
Jevtana 84 +8.1 % 321 +9.5 %
Thymoglobulin 69 +12.3 % 256 +6.0 %
Eloxatin 58 -24.3 % 227 -0.5 %
Taxotere 49 -33.8 % 222 -22.2 %
Mozobil 38 +12.9 % 143 +16.2 %
Zaltrap 18 -10.0 % 77 +5.8 %
Total Oncology 381 -7.9 % 1,504 -1.9 %
Fourth-quarter sales of Oncology were 381 million, down 7.9% impacted by lower sales of Eloxatin in the U.S. In 2015, sales of Oncology were 1,504 million, down 1.9%.
Sales of Jevtana increased 8.1% to 84 million in the fourth quarter led by the U.S. (up 19.2% to 35 million) and Japan where the product was launched in September 2014. In 2015, sales of Jevtana were up 9.5% to 321 million.
Sales of Thymoglobulin were up 12.3% to 69 million and 6.0% to 256 million in the fourth quarter and 2015, respectively.
Fourth-quarter sales of Eloxatin were down 24.3% (to 58 million) reflecting lower sales
in the U.S. which were partially offset by the continued good performance in China. Over the same period, sales of Taxotere decreased 33.8% (to 49 million), reflecting generic
competition especially in Japan. In 2015, sales of Eloxatin and Taxotere were down 0.5% ( 227 million) and down 22.2% ( 222
million), respectively. A generic of Eloxatin was recently introduced in Canada.
Mozobil grew 12.9% (to 38 million) and 16.2% (to 143 million) in the fourth quarter and in 2015, respectively.
Established Rx Products
million Q4 2015 net sales Change (CER) 2015 net sales Change (CER)
Plavix 455 -14.2 % 1,929 -4.1 %
Lovenox 419 -3.4 % 1,719 -0.5 %
Renvela /Renagel 239 +0.9 % 935 +18.9 %
Aprovel /Avapro 170 -7.9 % 762 -3.7 %
Synvisc /Synvisc-One 116 +4.0 % 413 +2.3 %
Multaq 85 0.0 % 341 +0.7 %
Myslee /Ambien /Stilnox 85 +2.6 % 306 -6.2 %
Allegra 44 +2.4 % 194 -3.6 %
AuviQ /Allerject -118 -5
Other 1,204 -7.7 % 5,039 -3.5 %
Total Established Rx Products 2,699 -10.4 % 11,633 -2.3 %
Fourth-quarter sales of Established Rx Products were 2,699 million, down 10.4%. Excluding AuviQ /Allerject , sales of Established Rx Products were down 6.5%.
Sales of Plavix decreased 14.2% to 455 million in the fourth quarter reflecting generic
competition in Japan beginning in June 2015 (sales in Japan were down 36.5% to 144 million), which was partially offset by continued strong performance in China (up 17.0% to 174 million). In 2015, Plavix decreased 4.1% to 1,929 million with sales in Japan of 695 million (down 12.5%) and China of 660 million (up 13.1%).
Sales of Lovenox were 419 million in the
fourth quarter, down 3.4% impacted by generic competition in the U.S. In Emerging Markets and in Western Europe, sales of Lovenox were up 2.0% (to 151 million) and stable (at 227 million), respectively. Sanofi is aware of competitors
Last updated: Feb 9, 2016