Full Press Release Details
Sanofi delivers solid 2012 results despite patent expirations
| Q4 2012 | Change on a reported basis | Change at constant exchange rates 1 | FY 2012 | Change on a reported basis | Change at constant exchange rates | |||||||||||||||||||
| Net sales | 8,526m | +0.2 | % | -1.7 | % | 34,947m | +4.7 | % | +0.5 | % | ||||||||||||||
| Business net income 1 | 1,572m | -24.3 | % | -27.1 | % | 8,179m | -7.0 | % | -12.9 | % | ||||||||||||||
| Business EPS 1 | 1.19 | -23.7 | % | -26.3 | % | 6.20 | -6.8 | % | -12.8 | % |
In order to facilitate an understanding of our operational performance, we comment on our
business net income statement. Business net income1 is a non-GAAP
financial measure. The consolidated income statement for 2012 is provided in Appendix 6 and a reconciliation of business net income to consolidated net income in Appendix 5. Consolidated net income for 2012 was 4,967 million, compared to
5,693 million for 2011. Consolidated EPS for 2012 was 3.76 versus 4.31 for 2011.
Commenting on the Group s performance in 2012, Sanofi Chief Executive Officer, Christopher A.
2012 was a turning point for Sanofi with the loss of
exclusivity in the U.S. for several significant legacy drugs. Despite the effect of the patent cliff, Sanofi was able to grow sales and mitigate the impact on Business EPS1. At the same time, Sanofi was able to obtain nine significant regulatory approvals and submit six new files with
regulatory agencies. Although the financial results in the first half will experience a residual effect from patent expirations, we expect to resume growth in the second half of 2013. This will be driven primarily by continued strong performance
from our growth platforms2 which now represent more than
70% of our sales and rose nearly 10%3 in 2012. We are on
track to meet our 2012-2015 objectives for sustainable growth .
(1) See Appendix 9 for definitions of financial indicators; (2) See page 2;
(3) 7.8% with Genzyme pro forma; (4) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 9 for a definition); (5) New Genzyme consists of rare diseases products and
Multiple Sclerosis products; (6) See definition on page 8; (7) 2012 business EPS with the retroactive application of IAS19R: 6.14.
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2012 fourth-quarter and full-year net sales
Unless otherwise indicated, all sales growth figures in this press release are
stated at constant exchange rates1.
In the fourth quarter of 2012, Sanofi generated sales of 8,526 million, an increase of 0.2% on a reported basis. Exchange
rate movements had a positive effect of 1.9 percentage points primarily reflecting the appreciation of the U.S. dollar and, to a lesser extent, the appreciation of the Chinese Yuan, Mexican Peso, Australian dollar and British Pound against the Euro.
At constant exchange rates, and adjusting for changes in the scope of consolidation (primarily the return of
Copaxone to Teva and the disposal of Dermik), net sales increased by 0.4%.
Net sales in 2012 reached 34,947 million, an increase of 4.7% on a reported basis. Exchange rate movements had a
favorable effect of 4.2 percentage points driven by the appreciation of the U.S. dollar and, to a lesser extent, the appreciation of the Japanese Yen and Chinese Yuan against the Euro. At constant exchange rates, and adjusting for changes in the
scope of consolidation (primarily the consolidation of Genzyme from the second quarter of 2011, the return of
Copaxone to Teva and the disposal of Dermik), net sales increased by 0.3%.
In the fourth quarter
of 2012, sales of the Group s growth platforms totaled 6,002 million, an increase of 11.5%, with growth exceeding 20% for Vaccines, Diabetes, new Genzyme and Other Innovative Products . The Group s growth
platforms accounted for 70.4% of total consolidated sales in the fourth quarter of 2012, up from 61.8% in the comparable quarter of 2011. In 2012, growth platforms (including new Genzyme ) recorded sales of 23,548 million, up
9.9 % or 7.8% with Genzyme pro forma (sales of Genzyme were not consolidated in the first quarter of 2011). Growth platforms sales comprised 67.4% of total consolidated sales compared with 61.7% in 2011.
Net sales of Growth Platforms
| ( million) | Q4 2012 net sales | Change at constant exchange rates | 2012 net sales | Change at constant exchange rates | ||||||||||||
| Emerging Markets*/** | 2,877 | +6.8 | % | 11,145 | +8.3 | % | ||||||||||
| Emerging Markets excluding Diabetes, Vaccines, CHC, Animal Health, new Genzyme and Other Innovative Products | 1,552 | -2.9 | % | 6,286 | +0.5 | % | ||||||||||
| Diabetes | 1,549 | +20.9 | % | 5,782 | +16.7 | % | ||||||||||
| Vaccines | 1,016 | +20.5 | % | 3,897 | +5.7 | % | ||||||||||
| Consumer Health Care (CHC) | 732 | +11.2 | % | 3,008 | +9.9 | % | ||||||||||
| Animal Health | 506 | +6.6 | % | 2,179 | +3.1 | % | ||||||||||
| New Genzyme | 481 | +22.2 | % | 1,785 | +16.9 | %*** | ||||||||||
| Other Innovative products**** | 166 | +23.7 | % | 611 | +10.5 | % | ||||||||||
| Total Growth Platforms | 6,002 | +11.5 | % | 23,548 | +9.9 | % | ||||||||||
| Total Growth Platforms with Genzyme pro forma | 6,002 | +11.5 | % | 23,548 | +7.8 | % |
In the fourth quarter of 2012, sales for the
Pharmaceuticals business were 7,004 million, a decrease of 4.8%, which reflected generic competition, EU austerity measures, the loss of sales of Copaxone (impact of 86 million) and the disposal of Dermik (impact of 35 million). Net sales lost due to generic competition on main legacy products in the
U.S. and in EU were 499 million, primarily due to declining sales of Eloxatin and Lovenox in the U.S. and Aprovel in the EU.
Full-year sales for the
Pharmaceuticals business reached 28,871 million, a decrease of 0.4%, which included the positive contribution from Genzyme (consolidated from April 2011). In 2012, net sales lost to generic competition on main legacy products in the U.S.
and in EU were 1,345 million, mainly due to Lovenox , Taxotere , Eloxatin in the U.S. and to
Aprovel , Taxotere and Plavix in the EU.
| (millions of euros) | Q4 2012 net sales | Change at constant exchange rates | 2012 net sales | Change at constant exchange rates | ||||||||||||
| Lantus | 1,335 | +22.6 | % | 4,960 | +19.3 | % | ||||||||||
| Plavix | 503 | -6.2 | % | 2,066 | -4.6 | % | ||||||||||
| Lovenox | 441 | -13.1 | % | 1,893 | -12.0 | % | ||||||||||
| Aprovel | 212 | -34.1 | % | 1,151 | -13.3 | % | ||||||||||
| Renvela /Renagel | 177 | +19.6 | % | 653 | +13.0 | %* | ||||||||||
| Cerezyme | 171 | +26.1 | % | 633 | +6.0 | %* | ||||||||||
| Taxotere | 125 | -17.3 | % | 563 | -41.9 | % | ||||||||||
| Myozyme / Lumizyme | 121 | +11.1 | % | 462 | +11.4 | %* | ||||||||||
| Synvisc / Synvisc One | 90 | -1.1 | % | 363 | +4.0 | %* | ||||||||||
| Fabrazyme | 84 | +74.5 | % | 292 | +96.4 | %* | ||||||||||
| Eloxatin | 68 | -80.0 | % | 956 | -17.3 | % | ||||||||||
| Apidra | 65 | +82.9 | % | 230 | +16.8 | % | ||||||||||
| Multaq | 63 | -4.7 | % | 255 | -8.0 | % | ||||||||||
| Jevtana | 60 | +25.5 | % | 235 | +20.2 | % | ||||||||||
| Zaltrap | 18 | 25 | ||||||||||||||
| Aubagio | 7 | 7 |
the Diabetes business totaled 1,549 million in the fourth quarter, reflecting record growth (+20.9%) driven by Lantus (+22.6% to 1,335 million) and the recovery of Apidra (+82.9% to 65 million). The solid performance of Lantus was supported by sales in the U.S. (+29.0% to 843 million) and Japan (+24.2% to 42 million). Sales in Emerging Markets grew 19.2% to 210 million. In
the U.S., Lantus SoloSTAR represented 53.4% of total
Lantus sales in the quarter, versus 50.0% in the fourth quarter of 2011. In the Emerging Markets,
Lantus sales growth was particularly strong in China (+26.0%), Brazil (+18.7%), Africa and the Middle
East (+24.3%). Full-year sales of Lantus were 4,960 million, up 19.3%. In October 2012, Sanofi
launched AllStar in India, the first Indian-manufactured, re-usable insulin pen, made by a global company in India. Sanofi intends to make AllStar accessible to other emerging markets throughout 2013.
In February 2013, the European Commission granted marketing authorisation in Europe for Lyxumia (lixisenatide licensed from Zealand Pharma). Lyxumia , the first once-daily prandial GLP-1 receptor agonist, is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in
combination with oral glucose-lowering medicinal products and / or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. Following the completion of pricing and reimbursement discussions, Sanofi
will initiate a progressive launch of Lyxumia throughout the European Union.
returned to strong growth in the fourth quarter (+82.9% to 65 million) after several quarters that were impacted by supply issues. Apidra recorded solid performance in all regions. Sales of Apidra in 2012 were 230 million (+16.8%).
In the fourth quarter, Amaryl recorded double-digit growth
in Emerging Markets (+10.3% to 65 million). Total sales decreased 11.5% to 102 million due to generic competition in Japan (where sales decreased 33.9% to 30 million). Sales of Amaryl in 2012 were 421 million (-8.0%), of which 62.5% were generated in Emerging Markets ( 263
million), an increase of 11.4%.
In 2012, the Diabetes business recorded a strong performance with sales growth of 16.7% to 5,782
In the fourth quarter, sales of Zaltrap (ziv-aflibercept,
collaboration with Regeneron) in the U.S. were 18 million. Zaltrap was launched at the end of August in
the U.S. and reached sales of 25 million in 2012. This quarter reflected the full impact of the loss of market exclusivity of Eloxatin in the U.S. which occurred on August 9, 2012, resulting in a 95.4% decrease in Eloxatin U.S. sales (to 12 million) and a 80.0% decrease in Eloxatin total sales to 60 million.
Taxotere recorded sales of 125 million (-17.3%) in the fourth quarter, reflecting generic erosion in the U.S. ( 6 million, -57.1%) and Western Europe ( 9
million, -65.2%). Sales of Taxotere in 2012 totaled 563 million (- 41.9%), of which
457 million was generated outside the U.S. and Western Europe.
Fourth-quarter sales of Jevtana increased 25.5% to 60 million, reflecting recent launches in Western Europe and certain Emerging Markets.
Full-year sales of Jevtana totaled 235 million, an increase of 20.2%.
Sales of Mozobil reached 25 million (+25.0%) and 96 million (+19.7%*) in the fourth quarter and 2012, respectively.
Fourth-quarter sales of the Oncology business decreased 38.7% to 417 million. Full-year sales of this business decreased 14.3% to
In February 2013, the European Commission granted marketing authorization in Europe for
Zaltrap (aflibercept) in combination with irinotecan/5-fluorouracil/folinic acid chemotherapy in adult
with metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen.
Worldwide presence1 of
Plavix /Iscover and Aprovel /Avapro /Karvea /Avalide
Sanofi and Bristol-Myers Squibb (BMS) announced a restructuring of their successful long-term alliance following the loss of exclusivity of Plavix and Avapro /Avalide in many major markets. Under the terms of the revised agreement, on January 1, 2013, BMS returned to Sanofi its
rights to Plavix and Avapro /Avalide in all markets
worldwide with the exception of Plavix in the U.S. and Puerto Rico, giving Sanofi sole control and freedom to operate commercially. In exchange, BMS receives royalty payments on Sanofi s sales of branded and unbranded Plavix worldwide, excluding the U.S. and Puerto Rico, and on sales of branded and unbranded Avapro /Avalide worldwide, in each case through 2018 (Japan remains excluded from the Alliance). In addition, BMS will receive a terminal payment of $200 million from Sanofi in
December 2018. Plavix rights in the U.S. and Puerto Rico will continue unchanged under the terms of the
existing agreement through December 2019.
The fourth-quarter worldwide presence of Plavix was down 68.8% to 554 million, reflecting generic competition in the U.S., following the loss of
exclusivity on May 17, 2012. U.S. sales, for which Sanofi receives royalties and sells active ingredients, declined by 98.8% to 15 million. In Europe, sales of Plavix decreased 18.0% to 107 million, also reflecting generic competition. In Emerging Markets, fourth-quarter consolidated sales grew 2.2% to 196 million.
Consolidated sales in China reached 83 million, an increase of 6.4% notwithstanding a 9.9% price decrease in October. In Japan, sales of Plavix reached 235 million, an increase of 14.6%. In 2012, the worldwide presence of Plavix was 3,984 million, down 46.2%. Sales of Plavix in Japan and China in 2012 were 837 million (+16.0%) and 371 million (+20.6%), respectively.
Worldwide presence of Plavix /Iscover : geographic split
| (millions of euros) | Q4 2012 | Change at constant exchange rates | 2012 | Change at constant exchange rates | ||||||||||||
| Europe | 107 | -18.0 | % | 453 | -21.2 | % | ||||||||||
| United States | 15 | -98.8 | % | 1,829 | -63.7 | % | ||||||||||
| Other Countries | 432 | -7.8 | % | 1,702 | -4.6 | % | ||||||||||
| TOTAL | 554 | -68.8 | % | 3,984 | -46.2 | % |
In the fourth quarter, the worldwide presence of Aprovel /Avalide decreased 41.7% to 252 million, reflecting generic competition in the U.S. and Europe. In the U.S., where the product lost its exclusivity on
March 30, 2012, sales declined 88.0%. European sales decreased 49.3% to 100 million. Consolidated sales of the product in Emerging Markets increased 5.7% to 96 million. The 2012 worldwide presence of Aprovel was 1,372 million, down 26.6%.
Worldwide presence of Aprovel /Avapro /Karvea : geographic split
| (millions of euros) | Q4 2012 | Change at constant exchange rates | 2012 | Change at constant exchange rates | ||||||||||||
| Europe | 100 | -49.3 | % | 626 | -24.3 | % | ||||||||||
| United States | 10 | -88.0 | % | 134 | -66.5 | % | ||||||||||
| Other Countries | 142 | -6.0 | % | 612 | -5.1 | % | ||||||||||
| TOTAL | 252 | -41.7 | % | 1,372 | -26.6 | % |
Other Pharmaceutical Products
Sales of Lovenox in the fourth quarter were 441 million, down 13.1%, due to generic pressure in the U.S. where sales of the branded product declined 54.2% to 55
million. Sanofi commercializes an authorized generic of Lovenox in the U.S. (sales are booked in the Generics
business). In Emerging Markets, sales of the product increased 5.0% to 149 million over the quarter. Full-year sales of Lovenox reached 1,893 million (-12.0%), of which 83.1% ( 1,574 million) was generated outside the U.S. (+5.5%). In Emerging Markets, full-year sales
increased 11.6% to 615 million.
Fourth-quarter sales of
Renvela /Renagel increased 19.6% to 177 million, sustained by the U.S. (sales were up 18.2% to 123 million) and Emerging Markets (sales were 16 million
vs. 6 million in Q4 2011). Full-year sales of Renvela /Renagel were 653 million, up 13.0%*. Genzyme and generic manufacturers settled pending U.S. litigation with
regard to the production and sale of generic formulations of Renvela tablets, Renvela for oral suspension and Renagel . According to the terms of the settlements, the first-filer for each product can enter the U.S. market on March 16, 2014 and second-filers can enter the market
on September 16, 2014, or earlier under certain circumstances, pending approval of their generic application.
Ambien family of products recorded sales of 117 million (-14.6%) in the fourth quarter. In
Japan, due to the entry of generics, sales decreased 19.8% to 68 million. Worldwide sales of the