Sanofi Q1 2014 Business EPS up 5.8% at CER

Sanofi Q1 2014 Business EPS up 5.8% at CER

Paris, April 29, 2014 / PRNewswire / — Sanofi (NYSE: SNY; EURONEXT: SAN)

Total Group sales(2) increased 3.5% to €7,842 million while our growth platforms(3) sales grew 7.9% to €5,776
million and accounted for 73.7% of total sales in Q1 2014.
 First quarter business net income(1) and business EPS(1) were €1,547 million (+5.6% at CER) and €1.17 (+5.8%
at CER, -3.3% on a reported basis), respectively.
 Free Cash Flow after capital expenditures increased by 20.6% to €1,396 million.
 The first dengue vaccine Phase III study in Asia met its primary endpoint with a 56% reduction of dengue
disease cases.
 Positive results from the Phase III ODYSSEY MONO study with alirocumab were presented at the ACC
medical congress; we expect top line readouts from 9 additional Phase III studies by the end of Q3 2014.
 Positive Phase IIa study results evaluating dupilumab in Atopic Dermatitis were presented at the AAAAI
medical meeting. Top line Phase IIb data are anticipated to report in the second quarter followed by an
expected Phase III initiation in Q3 2014.
 The Phase III program for LixiLan, the Fixed-Ratio combination of Lantus®
/Lyxumia®
, was recently initiated.
 Genzyme is expected to resubmit the LemtradaTM sBLA for FDA review in Q2 2014.
 Chattem launched Nasacort®
OTC nasal spray in February 2014 while Merial launched NexGardTM, our next
generation flea and tick product, in Q1 2014 in the U.S.
 Sanofi will use the equity method to account for its 20% ownership interest in Regeneron from April 4, 2014.
 The performance of the first quarter is in line with the full year guidance announced on February 6, 2014. The
continued performance of growth platforms, expenses in new product launches and the late-stage pipeline is
expected to lead to 2014 business EPS(1) growth between 4% and 7% at CER, barring major unforeseen
adverse events.

Sanofi Chief Executive Officer, Christopher A. Viehbacher commented: 

"The Group's financial performance in the first-quarter continued the growth trajectory that emerged at the 

end of 2013. Our Business EPS(1) grew 5.8% at CER which is in line with our full-year financial 

guidance. Importantly, our pipeline showed steady progress. We presented study results for alirocumab, 

dupilumab, initiated the LixiLan Phase III program and announced plans to resubmit the sBLA for 

LemtradaTM. In addition, the first dengue vaccine Phase III study met its primary endpoint. During the next 

three quarters of 2014, we expect important development milestones for multiple high potential pipeline 

projects including ToujeoTM (U300), the Dengue vaccine, alirocumab, Cerdelga®

 and dupilumab."

 

2014 first-quarter net sales 

Unless otherwise indicated, all sales growth figures in this press release are stated at constant exchange rates(1). 

In the first quarter of 2014, Sanofi generated sales of €7,842 million, a decrease of 2.7% on a reported basis. 

Exchange rate movements had a negative effect of 6.2 percentage points primarily reflecting the depreciation of 

the U.S. Dollar, Japanese Yen, Brazilian Real, Russian Ruble, Argentine Peso, Turkish Lira and the Australian 

Dollar against the Euro. 

 

Growth Platforms 

In the first quarter, sales of the Group's growth platforms totaled €5,776 million, an increase of 7.9%, driven by 

the performance of Diabetes (up 13.2%), CHC (up 18.6%), Genzyme (up 21.5%) and "Other Innovative Products" 

(up 22.6%). The Group's growth platforms accounted for 73.7% of total consolidated sales in the first quarter, up 

from 71.0% in the first quarter of 2013. 

 

Pharmaceuticals 

Sales for Pharmaceuticals increased 4.7% to €6,697 million in the first quarter of 2014 driven by Genzyme, 

Diabetes and CHC.

The Diabetes division generated sales of €1,662 million in the first quarter, an increase of 13.2%. Lantus®

 sales 

were up 13.5% to €1,448 million driven by the U.S. (+14.5% to €951 million) and Emerging Markets (+17.9% to 

€225 million). In the U.S., Lantus®

 volume sell-in was down this quarter given unfavorable trade inventory 

fluctuations (around €70 million). Lantus®

 SoloSTAR®

 represented 60.8% of total Lantus®

 sales in the quarter in 

the U.S., versus 57.0% in the first quarter of 2013. In China, Lantus®

 sales grew 39.4% to €45 million. Sales of 

Lantus®

 in Western Europe grew 5.6% to €208 million. 

Lyxumia®

 (lixisenatide), a once-daily prandial GLP-1 receptor agonist is now available in a number of countries 

such as Italy, Spain, Japan, Mexico, with additional launches expected in 2014. First-quarter sales of Lyxumia®

 

were €5 million. In Germany, Sanofi suspended in-country distribution of lixisenatide on April 1, 2014 given 

unsuccessful pricing negotiation with the National Association of Statutory Health Insurance Funds (SpiBu). An 

arbitration process is ongoing and after the completion of this process, Sanofi will reassess the situation. 

Sales of Apidra®

 increased 19.7% to €75 million in the first quarter driven by Western Europe (+21.1% to €23 

million) and Emerging Markets (+28.6% to €17 million). 

First-quarter sales of Amaryl®

 were stable at €86 million reflecting 6.0% growth in Emerging Markets (€65 million) 

offset by generic competition in Japan where sales decreased 19.0% to €15 million. 

 

First-quarter sales of Consumer Healthcare products (CHC) grew 18.6% to €885 million. At the beginning of 

February, Nasacort®

 Allergy 24HR nasal spray was available over-the-counter (OTC) in the U.S. to relieve nasal 

allergy symptoms. Nasacort Allergy 24HR is the first and only medicine in its class to be available at full 

prescription strength without the need for a prescription. U.S. sales of Nasacort® were €36 million in the first 

quarter. In addition, Lactacyd®

 and Maalox®

 recorded double-digit growth in sales in the first quarter. 

Some products previously recorded in prescription pharmaceuticals in the first quarter of 2013 were transferred 

to Consumer Healthcare products and totaled €68 million. Excluding this change of perimeter, sales of CHC 

grew 9.4% reflecting the success of the Nasacort®

 Rx-to-OTC switch in the U.S. and strong performance in 

Emerging Markets (+13.7%). 

 

Genzyme first-quarter sales increased 21.5% to €566 million, driven by Aubagio®

 with sales of €78 million versus 

€20 million in the first quarter of 2013. Genzyme recorded double digit growth in all regions with +31.0% in the 

U.S. (€212 million), +18.2% in Emerging Markets (€112 million), +14.8% in Western Europe (€194 million) and 

+19.6% in the rest of the world (€48 million). 

First-quarter sales of Cerezyme®

, the leading therapy for Gaucher disease, were €168 million, an increase of 

5.8% driven by Emerging Markets (+10.0% to €56 million) and the U.S. (+7.0% to €45 million). 

Sales of Myozyme®

/Lumizyme®

 reached €121 million in the first quarter, an increase of 7.8%, supported by 

strong growth in Emerging Markets (+64.3% to €20 million). 

First-quarter sales of Fabrazyme®

 increased 13.0% to €98 million due to patient accruals globally. Fabrazyme®

 

continued to record strong growth in Western Europe (+25.0% to €25 million) reflecting market share gains. 

Fabrazyme®

 sales grew 12.8% to €51 million in the U.S. 

Sales of Aubagio®

 were €78 million in the first quarter of which €59 million were in the U.S. The launch of the 

product in the first Western European countries (specifically Germany, Switzerland and Nordic countries) started 

in the fourth quarter of 2013 and sales reached €17 million in the first quarter of 2014. 

Following its approval by the European Commission in September, Lemtrada™ (alemtuzumab, developed in 

collaboration with Bayer HealthCare to treat relapsing forms of multiple sclerosis) was launched in Germany in 

October 2013 with further roll-out across Europe expected in 2014. Lemtrada™ is also approved in Canada, 

Australia, Mexico and Brazil. First-quarter sales of the product were €5 million. 

 

First-quarter sales of Multaq®

 grew 21.0% to €73 million driven by the U.S. (€60 million, up 26.5%). Sales of 

Jevtana®

 increased 30.8% to €66 million in the first quarter, reflecting recent launches in Western Europe (€38 

million, up 58.3%). In the first quarter, sales of Zaltrap®

 (aflibercept, collaboration with Regeneron) reached €16 

million, an increase of 45.5% driven by recent launches in Western Europe (€7 million vs. €1 million in Q1 2013) 

which offset lower sales in the U.S. First-quarter sales of Mozobil®

 were stable at €25 million. Sales of 

Auvi-Q®

/AllerjectTM(5) which was launched in the U.S. in January 2013, were €10 million (+25.0%) in the first 

quarter. 

 

In the first quarter, sales of Plavix®

 grew 18.2% to €487 million. In Japan, sales were up 48.5% to €215 million 

reflecting strong underlying volume growth and favorable buying patterns in anticipation of an increase in the 

consumption tax. In Emerging Markets, sales grew 4.4% to €204 million. In China, sales reached €114 million, an 

increase of 6.4%. In Western Europe, sales of Plavix®

 decreased 4.6% to €62 million. 

Sales of Lovenox®

 were €416 million in the first quarter (up 1.4%), reflecting good performance in Western 

Europe (+7.5% to €229 million), in Emerging Markets (+4.2% to €135 million) and generic pressure in the U.S. 

where sales of the branded product declined 32.7% to €32 million. 

First-quarter sales of Aprovel®

/Avapro®

 decreased 22.8% to €179 million, due to generic competition in Western 

Europe where sales decreased 45.5% to €54 million. Sales of the product in Emerging Markets were relatively 

stable at €95 million. 

Sales of Renvela®

/Renagel®

 totaled €172 million in the first quarter (up 5.3%) reflecting good performance in 

Emerging Markets (sales of €22 million vs. €13 million in Q1 2013) and slightly lower sales in the U.S. (down 

2.5% to €114 million). 

In the first quarter, sales of Allegra®

 as a prescription drug were €80 million, down 46.2% and sales of the 

Ambien® family of products were €78 million, down 14.9%, reflecting generic competition in Japan for both 

products. 

Sales of Synvisc®

/Synvisc One®

 were €70 million (down 3.9%) in the first quarter, impacted by lower sales in the 

U.S. (down 12.7% to €53 million). 

First-quarter sales of Taxotere®

 decreased 28.7% to €69 million, reflecting generic erosion in the U.S. and 

Western Europe and lower sales in Emerging Markets (€39 million, down 23.2%). Sales of Eloxatin®

 decreased 

15.3% to €46 million in the first quarter of 2014. 

 

 

Generics 

In the first quarter, sales of Generics totaled €421 million, an increase of 8.0%, reflecting the recovery in Brazil 

where sales grew to €52 million partially offset by lower sales of the authorized generics of Lovenox®

 and of 

Taxotere®

 in the U.S. In Emerging Markets, sales of generics increased 23.6% to €244 million due to the strong 

improvement in Brazil. 

 

First-quarter consolidated sales of Sanofi Pasteur were €628 million, a decrease of 4.2%, reflecting a phasing 

effect in Pentaxim® deliveries in Emerging Markets and strong sales for Imovax®

 in Japan and Menactra®

 in the 

previous year period. In the U.S., sales grew 23.8% to €279 million, driven by the continued gradual Pentacel®

 

recovery. In Emerging Markets, sales were €261 million, a decrease of 15.0% due to Pentaxim®

 phasing. 

 

First-quarter sales of Polio/Pertussis/Hib vaccines reached €211 million, a decrease of 15.9%. The first-quarter 

performance was impacted by timing of supply of Pentaxim® in Mexico and China and lower sales of Imovax®

 in 

Japan due to the end of the catch-up cohort following its launch in September 2012. As expected, the first quarter 

performance reflected continued gradual Pentacel®

 recovery in the U.S. 

Sales of influenza vaccines increased 19.3% to €135 million in the first quarter and included €16 million of H7N9 

flu vaccines in the U.S. Sales of influenza vaccines were €21 million in the U.S., an increase of 40.0% (including 

H7N9 flu vaccines). In Emerging Markets, sales of influenza vaccines grew 17.2% to €105 million. 

Sales of Adult booster vaccines were stable at €81 million in the first quarter. Sales of Adacel®

 were €63 million, 

an increase of 4.8%, reflecting a gradual supply recovery from Adacel®

 in the U.S. 

First-quarter sales of travel and other endemic vaccines increased 10.8% to €75 million driven by higher 

Typhim Vi® sales. 

First-quarter sales of Menactra®

 were €48 million, a decrease of 23.9%, reflecting a strong baseline in the first 

quarter of 2013 which benefited from a meningitis outbreak in Latin America and lower sales in Middle East. 

First-quarter sales of Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe, were 

€158 million (a decrease of 8.8% on a reported basis), reflecting strong baseline for Gardasil®

 due to the catch up 

program in Nordic countries in the first quarter of 2013 and lower sales for pediatric vaccines tied to changes in 

the vaccine schedule implemented in April 2013 in France. 

 

First-quarter sales of Animal Health were €517 million, down 1.6%. In Emerging Markets, sales grew 3.9% to 

€121 million. 

Sales of the Companion Animals segment were €344 million, a decrease of 3.7% in the first quarter. Merial 

started to prepare for the flea and tick season by introducing NexGardTM for dogs in the U.S. and in France in the 

first quarter. BroadlineTM, a unique product in the fight against external and internal parasites for cats and kittens, 

was also launched in France. Sales of NexGardTM were €23 million while sales of the anti-parasiticide 7 

 

Frontline®

/fipronil family of products were down 8.3% to €169 million. Furthermore, in the first quarter of 2013, 

Heartgard®

 (avermectin products line) benefited from a competitor supply issue in the U.S. 

First-quarter sales of the Production Animals segment were €173 million, an increase of 2.8% driven by the 

performance of the swine business. 

 

 

First-quarter sales in Emerging Markets were €2,590 million, an increase of 5.5%. Double-digit growth was 

recorded for Diabetes (+16.1%), CHC and Genzyme (+18.2%). Latin America reported double-digit sales growth 

over the period driven by the performance in Brazil. Sales in Brazil grew 19.9% to €359 million, reflecting a 

recovery of Generics (+113.3% to €52 million), strong performance of Diabetes (+25.0%) and vaccines (up 

39.1%). Sales in China increased 10.3% to €377 million driven primarily by the performance of Diabetes and CHC 

partially offset by lower sales of vaccines due to timing of supply of Pentaxim®

. Sales in Eastern Europe/Russia 

and Turkey increased 4.0% to €604 million driven by Russia (+8.8% to €195 million) and Turkey (+15.5%). Sales 

in Africa were €233 million, down 11.0%, reflecting changes in buying patterns and inventory policies by some 

customers in Algeria and Morocco. 

First-quarter sales in the U.S. grew 7.5% to €2,415 million driven by strong performances from Diabetes 

(+14.4%), Genzyme (+31.0%), Vaccines (+23.8%) and CHC (+18.1%) supported by the success of the Nasacort®

 

Rx-to-OTC switch. 

First-quarter sales in Western Europe were stable (-0.3%) at €1,998 million, reflecting continued growth of 

Diabetes (+8.3%) and Genzyme (+14.8%) offset by generic competition to Aprovel®

Sales in Japan were €587 million, a decrease of 2.5%, reflecting generic competition to Allegra®

, Myslee®

 and 

Amaryl®

 and lower sales of Imovax®

 

First-quarter sales in Emerging Markets were €2,590 million, an increase of 5.5%. Double-digit growth was 

recorded for Diabetes (+16.1%), CHC and Genzyme (+18.2%). Latin America reported double-digit sales growth 

over the period driven by the performance in Brazil. Sales in Brazil grew 19.9% to €359 million, reflecting a 

recovery of Generics (+113.3% to €52 million), strong performance of Diabetes (+25.0%) and vaccines (up 

39.1%). Sales in China increased 10.3% to €377 million driven primarily by the performance of Diabetes and CHC 

partially offset by lower sales of vaccines due to timing of supply of Pentaxim®

. Sales in Eastern Europe/Russia 

and Turkey increased 4.0% to €604 million driven by Russia (+8.8% to €195 million) and Turkey (+15.5%). Sales 

in Africa were €233 million, down 11.0%, reflecting changes in buying patterns and inventory policies by some 

customers in Algeria and Morocco. 

First-quarter sales in the U.S. grew 7.5% to €2,415 million driven by strong performances from Diabetes 

(+14.4%), Genzyme (+31.0%), Vaccines (+23.8%) and CHC (+18.1%) supported by the success of the Nasacort®

 

Rx-to-OTC switch. 

First-quarter sales in Western Europe were stable (-0.3%) at €1,998 million, reflecting continued growth of 

Diabetes (+8.3%) and Genzyme (+14.8%) offset by generic competition to Aprovel®

Sales in Japan were €587 million, a decrease of 2.5%, reflecting generic competition to Allegra®

, Myslee®

 and 

Amaryl®

 and lower sales of Imovax®

 

First-quarter sales in Emerging Markets were €2,590 million, an increase of 5.5%. Double-digit growth was 

recorded for Diabetes (+16.1%), CHC and Genzyme (+18.2%). Latin America reported double-digit sales growth 

over the period driven by the performance in Brazil. Sales in Brazil grew 19.9% to €359 million, reflecting a 

recovery of Generics (+113.3% to €52 million), strong performance of Diabetes (+25.0%) and vaccines (up 

39.1%). Sales in China increased 10.3% to €377 million driven primarily by the performance of Diabetes and CHC 

partially offset by lower sales of vaccines due to timing of supply of Pentaxim®

. Sales in Eastern Europe/Russia 

and Turkey increased 4.0% to €604 million driven by Russia (+8.8% to €195 million) and Turkey (+15.5%). Sales 

in Africa were €233 million, down 11.0%, reflecting changes in buying patterns and inventory policies by some 

customers in Algeria and Morocco. 

First-quarter sales in the U.S. grew 7.5% to €2,415 million driven by strong performances from Diabetes 

(+14.4%), Genzyme (+31.0%), Vaccines (+23.8%) and CHC (+18.1%) supported by the success of the Nasacort®

 

Rx-to-OTC switch. 

First-quarter sales in Western Europe were stable (-0.3%) at €1,998 million, reflecting continued growth of 

Diabetes (+8.3%) and Genzyme (+14.8%) offset by generic competition to Aprovel®

Sales in Japan were €587 million, a decrease of 2.5%, reflecting generic competition to Allegra®

, Myslee®

 and 

Amaryl®

 and lower sales of Imovax®

 

First-quarter sales in Emerging Markets were €2,590 million, an increase of 5.5%. Double-digit growth was 

recorded for Diabetes (+16.1%), CHC and Genzyme (+18.2%). Latin America reported double-digit sales growth 

over the period driven by the performance in Brazil. Sales in Brazil grew 19.9% to €359 million, reflecting a 

recovery of Generics (+113.3% to €52 million), strong performance of Diabetes (+25.0%) and vaccines (up 

39.1%). Sales in China increased 10.3% to €377 million driven primarily by the performance of Diabetes and CHC 

partially offset by lower sales of vaccines due to timing of supply of Pentaxim®

. Sales in Eastern Europe/Russia 

and Turkey increased 4.0% to €604 million driven by Russia (+8.8% to €195 million) and Turkey (+15.5%). Sales 

in Africa were €233 million, down 11.0%, reflecting changes in buying patterns and inventory policies by some 

customers in Algeria and Morocco. 

First-quarter sales in the U.S. grew 7.5% to €2,415 million driven by strong performances from Diabetes 

(+14.4%), Genzyme (+31.0%), Vaccines (+23.8%) and CHC (+18.1%) supported by the success of the Nasacort®

 

Rx-to-OTC switch. 

First-quarter sales in Western Europe were stable (-0.3%) at €1,998 million, reflecting continued growth of 

Diabetes (+8.3%) and Genzyme (+14.8%) offset by generic competition to Aprovel®

Sales in Japan were €587 million, a decrease of 2.5%, reflecting generic competition to Allegra®

, Myslee®

 and 

Amaryl®

 and lower sales of Imovax®

Link to the full release: (PDF) 

 

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