PRESS RELEASE
1
Q1 2014 Business EPS(1) up 5.8% at CER
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."
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(1) See Appendix 6 for definitions of financial indicators; (2) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see
Appendix 6 for a definition); (3) See page 2.
Paris, April 29, 2014
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 in the App Store and on Google Play
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2014 first-quarter key figures
Q1 2014 Change (reported) Change (CER)
Net sales €7,842m -2.7% +3.5%
Business net income(1) €1,547m -3.2% +5.6%
Business EPS(1) €1.17 -3.3% +5.8%
In order to facilitate an understanding of our operational performance, we comment on our business net income statement. Business net income(1)
is a non-GAAP financial measure. The consolidated income statement for Q1 2014 is provided in Appendix 4 and a reconciliation of business net
income to consolidated net income in Appendix 3. Consolidated net income for Q1 2014 was €1,084 million, compared to €989 million for Q1
2013. Consolidated EPS for Q1 2014 was €0.82 versus €0.75 for Q1 2013.
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.
€ million Q1 2014
net sales
Change at
CER
Diabetes 1,662 +13.2%
Consumer Healthcare (CHC) 885 +18.6%
Vaccines 628 -4.2%
Genzyme 566 +21.5%
Animal Health 517 -1.6%
Other Innovative products(a) 190 +22.6%
Emerging Markets(b) 2,590 +5.5%
of which Diabetes, Vaccines, CHC, Animal Health, Genzyme
and Other Innovative Products 1,262 +12.4%
of which other products 1,328 -0.3%
Total Growth Platforms 5,776 +7.9%
(a) Includes products launched since 2009 which do not belong to the other Growth Platforms listed above: Multaq, Jevtana, Zaltrap, Auvi-
QTM/Allerject and Mozobil
(b) World excluding the U.S. and Canada, Western Europe, Japan, Australia and New Zealand
Pharmaceuticals
Sales for Pharmaceuticals increased 4.7% to €6,697 million in the first quarter of 2014 driven by Genzyme,
Diabetes and CHC.
(1) See Appendix 6 for definitions of financial indicators
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Diabetes
€ million Q1 2014
net sales
Change at
CER
Lantus 1,448 +13.5%
Amaryl 86 0.0%
Apidra 75 +19.7%
Insuman 32 +3.0%
Blood Glucose Monitoring 16 +45.5%
Lyxumia 5 –
Total Diabetes 1,662 +13.2%
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.
Consumer Healthcare
€ million Q1 2014
net sales
Change at
CER
Allegra 104 +14.1%
Doliprane 88 +7.2%
Essentiale 66 +45.1%
Enterogermina 38 +5.1%
Nasacort 42 –
No Spa 28 +3.3%
Maalox 27 +20.0%
Lactacyd 25 +11.1%
Dorflex 23 +7.7%
Other CHC Products 444 +11.8%
Total Consumer Healthcare 885 +18.6%
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%).
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Genzyme
€ million Q1 2014
net sales
Change at
CER
Cerezyme 168 +5.8%
Myozyme / Lumizyme 121 +7.8%
Fabrazyme 98 +13.0%
Aldurazyme 41 +16.2%
Total Rare Diseases 483 +8.5%
Aubagio 78 +305.0%
LemtradaTM 5 –
Total Multiple Sclerosis 83 +330.0%
Total Genzyme 566 +21.5%
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.
Other Innovative Products(4)
€ million Q1 2014
net sales
Change at
CER
Multaq 73 +21.0%
Jevtana 66 +30.8%
Mozobil 25 0.0%
Zaltrap 16 +45.5%
Auvi-Q/Allerject 10 +25.0%
Total Other Innovative Products 190 +22.6%
(4) Includes products launched since 2009 which do not belong to the other Growth Platforms
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.
(5) Sanofi US licensed the North America commercialization rights to Auvi-Q from Intelliject,Inc.
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Established Pharmaceutical Products
€ million Q1 2014
net sales
Change at
CER
Plavix 487 +18.2%
Lovenox 416 +1.4%
Aprovel/Avapro 179 -22.8%
Renvela/Renagel 172 +5.3%
Allegra 80 -46.2%
Myslee/Ambien/Stilnox 78 -14.9%
Synvisc / Synvisc One 70 -3.9%
Taxotere 69 -28.7%
Eloxatin 46 -15.3%
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.
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Vaccines
€ million Q1 2014
net sales
Change at
CER
Polio/Pertussis/Hib Vaccines (incl. Pentacel, Pentaxim and Imovax) 211 -15.9%
Influenza Vaccines (incl. Vaxigrip and Fluzone) 135 +19.3%
Adult Booster Vaccines (incl. Adacel ) 81 0.0%
Travel and Other Endemics Vaccines 75 +10.8%
Meningitis/Pneumonia Vaccines (incl. Menactra) 56 -25.0%
Other Vaccines 70 +4.3%
Total Vaccines (consolidated sales) 628 -4.2%
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.
Animal Health
€ million Q1 2014
net sales
Change at
CER
Companion Animal 344 -3.7%
Production Animal 173 +2.8%
Total Animal Health 517 -1.6%
of which fipronil products 171 -8.2%
of which NexGardTM 23 –
of which avermectin products 114 -14.8%
of which Vaccines 154 -1.2%
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
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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.
Net sales by geographic region
€ million Q1 2014
net sales
Change at
CER
Emerging Markets(a) 2,590 +5.5%
of which Latin America 734 +13.1%
of which Asia 734 +4.0%
of which Eastern Europe, Russia and Turkey 604 +4.0%
of which Africa 233 -11.0%
of which Middle East 253 +10.9%
United States 2,415 +7.5%
Western Europe(b) 1,998 -0.3%
Rest of the world(c) 839 -4.0%
of which Japan 587 -2.5%
TOTAL 7,842 +3.5%
(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
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.
R&D update
Consult Appendix 5 for full overview of Sanofi’s R&D pipeline
Regulatory update
Regulatory updates since the publication of the Full-year 2013 results on February 6, 2014 include the following:
In April, Sanofi and its subsidiary Genzyme announced that following constructive discussions with the
U.S. Food and Drug Administration (FDA) the company plans to resubmit in the second quarter its
supplemental Biologics License Application (sBLA) seeking approval of LemtradaTM (alemtuzumab) for
the treatment of relapsing forms of multiple sclerosis. The resubmission will provide information to
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specifically address issues noted by the FDA in its December 2013 Complete Response Letter. Once the
filing is accepted, the FDA will assign either a two month or six month review timeframe. Genzyme had
previously announced its intention to appeal the FDA’s Complete Response Letter. In light of the planned
resubmission, the company does not expect to pursue an appeal at this time.
In March, SAR650984, a monoclonal antibody anti-CD38, obtained a designation as an orphan medicinal
product from the European Medicines Agency for the treatment of myeloma.
In February, the European Commission approved NexGardTM (afoxolaner) for the treatment of flea and
tick infestations in dogs. NexGardTM can also be used as part of a treatment strategy for the control of
Flea Allergy Dermatitis.
At the end of April 2014, the R&D pipeline contained 50 projects (excluding Life Cycle Management) and vaccine
candidates in clinical development of which 12 are in Phase III or have been submitted to the health authorities
for approval.
Portfolio update
Phase III:
Sanofi Pasteur announced in April that the first of two pivotal Phase III efficacy studies with its dengue
vaccine candidate has achieved its primary clinical endpoint. The efficacy study showed a significant
reduction of 56% of dengue disease cases. Initial safety data are consistent with the good safety profile
observed in previous studies. Full analysis of the data will be undertaken in the coming weeks and
reviewed by external experts prior to disclosure at an upcoming international scientific congress and
publication in a peer-reviewed journal later this year. The results of this first, large-scale efficacy study will
be further complemented by results in the third quarter of 2014 from a second, large-scale study currently
conducted in Latin America, including more than 20,000 volunteers.
The first full data results from the Phase III ODYSSEY MONO study with alirocumab, an investigational
monoclonal antibody targeting PCSK9 (collaboration with Regeneron), were presented at the American
College of Cardiology’s 63rd Annual Scientific Session held in March. ODYSSEY is the global Phase III
trial program for investigational compound alirocumab. ODYSSEY currently comprises 14 clinical trials
enrolling more than 23,500 patients with hypercholesterolemia. We expect to report additional top-line
Phase III data, beginning in June 2014 through the third quarter of 2014. All ongoing Phase III studies
that are part of the ODYSSEY program are now fully enrolled (except ODYSSEY OUTCOMES).
The filing of alirocumab in hypercholesterolemia in EU is expected in the fourth quarter of 2014.
In April, Sanofi and Regeneron Pharmaceuticals, Inc. announced that the first Phase II study with
alirocumab in Japanese patients met its primary endpoint. The results demonstrated that the mean lowdensity
lipoprotein-cholesterol (LDL-C, or "bad" cholesterol) percentage reduction from baseline to week
12, the primary efficacy endpoint of the study, was significantly greater in patients randomized to receive
one of three doses of alirocumab administered every other week (Q2W) – 150 milligrams (mg), 75 mg,
and 50 mg, in combination with statin therapy, compared to patients receiving placebo. The Phase III
program has now started in Japan.
The Phase III program for LixiLan, the Fixed-Ratio combination of Lantus/Lyxumia, was recently
initiated.
Phase II:
ALN-TTRsc/SAR438714 (collaboration with Alnylam) is in Phase II development for the treatment of
Familial Amyloidotic Cardiomyopathy (FAC). Furthermore, in April, the European Medicines Agency
(EMA) Committee for Orphan Medicinal Products adopted a positive opinion recommending ALN-TTRsc
for designation as an orphan medicinal product.
In March, at the American Academy of Allergy, Asthma and Immunology Annual Meeting held in San
Diego, positive data from a Phase IIa trial evaluating dupilumab, a human monoclonal antibody targeting
the IL-4Rα subunit, administered for 12 weeks in patients with moderate-to-severe atopic dermatitis
poorly controlled by topical agents were presented. At 12 weeks, the dupilumab group achieved
statistically superior clinical outcomes compared to the placebo group in all measures of disease activity
and pruritus. Updated data including a follow-up assessment up to 78 days from a smaller Phase II trial
evaluating dupilumab co-administered with topical steroid (TCS) treatment were also presented. Relative
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to TCS alone, concomitant treatment with dupilumab and TCS provided marked, sustained, and
significant improvement in clinical efficacy measures, despite use of less TCS.
Sanofi has decided not to pursue the development of SAR 339658, an anti-VLA 2 monoclonal antibody,
in ulcerative colitis and will instead focus on evaluating the use of this compound in multiple sclerosis by
initiating a clinical Phase II study.
The development of SAR3419 in Acute Lymphocytic Leukemia has been discontinued.
Phase I:
Sanofi has decided not to exercise the licence option for RetinoStat.
New Collaborations:
In March, Sanofi and UCB announced they had entered into a scientific and strategic collaboration for the
discovery and development of innovative anti-inflammatory small molecules, which have the potential to treat a
wide range of immune-mediated diseases in areas such as gastroenterology and arthritis. UCB NewMedicines,
the research arm of UCB, has used an innovative approach to identify small molecule modulators of a biological
pathway, for which parenterally administered biologic therapies have proven highly efficacious in patients. A
dedicated team of scientists will be formed under the leadership of Sanofi and UCB, and will join forces in a
discovery and development based collaboration to characterize and identify new potential therapies.
Sanofi Pasteur, the vaccines division of Sanofi, announced in March a long-term strategic cooperation with SK
Chemical Co. to co-develop an innovative pneumococcal conjugate vaccine (PCV) with enhanced serotype
coverage. This agreement will enable Sanofi Pasteur to access the global PCV market of $4 billion. The World
Health Organization (WHO) recommends the use of PCVs in all countries.
First-quarter 2014 financial results
Business Net Income(1)
In the first quarter, Sanofi net sales reached €7,842 million, a decrease of 2.7% on a reported basis (+3.5% at
constant exchange rates). Other revenues were €83 million, a decrease of 15.3% reflecting the end of royalties
on Enbrel sales in the U.S. in the first quarter of 2013.
First-quarter Gross profit was €5,409 million, down 3.6% and up 2.8% at constant exchange rates. The ratio of
cost of sales to net sales (CoS ratio) reached 32.1%, an increase of 0.5 percentage points versus the first quarter
of 2013. This reflects a CoS ratio improvement for Pharmaceuticals (positive impact of 0.4 percentage points at
CER on the variation of the Group CoS ratio) but a dilutive impact of Vaccines and Animal Health (negative
impact of 0.3 percentage points at CER on the variation of the Group CoS ratio for each) as well as unfavorable
currency variations.
Research and Development expenses decreased 1.6% to €1,139 million. At constant exchange rates, Research
and Development expenses increased slightly by 1.1% reflecting investment in the late-stage portfolio.
In the first quarter, selling and general expenses were €2,078 million, down 2.9%. At constant exchange rates,
SG&A increased 2.5% reflecting investments in product launches (Aubagio, LemtradaTM, Nasacort OTC,
NexGardTM). The ratio of selling and general expenses to net sales was 26.5% versus 26.6% in the first quarter of
2013
Other current operating income net of expenses was -€25 million in the first quarter versus €29 million in the
first quarter of 2013 which included payments (€38 million) from Warner Chilcott related to Actonel in the U.S. In
the first quarter of 2014, this line included additional provisions related to ramipril litigation in Canada (€24
million).
The share of profits from associates was €13 million versus €18 million in the first quarter of 2013, while noncontrolling
interests decreased 14.6% to -€35 million.
(1) See Appendix 6 for definitions of financial indicators, and Appendix 3 for reconciliation of business net income to consolidated net income attributable to
equity holders of Sanofi
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Business operating income was €2,145 million, a decrease of 7.6%. At constant exchange rates, business
operating income grew 0.6%. The ratio of business operating income to net sales was 27.4%.
Net financial expenses were €76 million, compared to €140 million in the first quarter of 2013 and included a
capital gain of €41 million linked to the partial sale of a financial investment.
The first-quarter effective tax rate was 25%.
First-quarter business net income(1) was €1,547 million, a decrease of 3.2% and an increase of 5.6% at constant
exchange rates.
In the first quarter of 2014, Business earnings per share(1) (EPS) were €1.17, down 3.3% and up 5.8% on a
reported basis and at constant exchange rates, respectively. The average number of shares outstanding was
1,319.9 million this quarter versus 1,322.2 million in the first quarter of 2013.
From business net income to consolidated net income (see Appendix 3)
In the first quarter of 2014, the main reconciling items between business net income and consolidated net income
attributable to equity holders of Sanofi were:
– A €677 million amortization charge related to fair value remeasurement on intangible assets of acquired
companies (primarily Aventis: €257 million, Genzyme: €234 million and Merial €97 million) and to acquired
intangible assets (licenses/products: €20 million). This item has no cash impact on the Group.
– An impairment loss against intangible assets of €3 million. This item has no cash impact on the Group.
– A charge of €8 million mainly reflecting an increase in the fair value of contingent considerations related to
the CVRs (-€5 million) and Bayer contingent considerations (€12 million) linked to LemtradaTM .
– €51 million of restructuring costs mainly related to continuation of transformation in Europe and in the U.S.
– €35 million gain on Alnylam shares. This item has no cash impact on the Group.
– A €248 million tax effect arising from the items listed above, comprising €244 million generated by
amortization charged against intangible assets and €15 million associated with restructuring costs. (see
Appendix 3).
– In "Share of profits/losses from associates", a charge of €8 million, net of tax, mainly relating to the share
of amortization of intangible assets. This item has no cash impact on the Group.
Net Debt
In the first quarter of 2014, net cash generated by operating activities was €1,396 million after changes in working
capital (-€29 million) and capital expenditures (€279 million) but before restructuring costs. This amount largely
covered restructuring costs (€244 million), the repurchase of shares (€355 million), acquisitions and partnerships
(€1,556 million of which €954 million related to Regeneron and €530 million related to Alnylam). As a
consequence, net debt increased from €6,043 million at December 31, 2013 to €6,697 million at the end of March
2014 (amount net of €6,458 million cash and cash equivalents).
(1) See Appendix 6 for definitions of financial indicators, and Appendix 3 for reconciliation of business net income to consolidated net income attributable to equity
holders of Sanofi
11
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 forwardlooking
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 forwardlooking
information or statements.
Appendices
List of appendices
Appendix 1: 2014 first-quarter consolidated net sales net sales by geographic region and product
Appendix 2: 2014 first-quarter business net income statement
Appendix 3: Reconciliation of business net income to net income attributable to equity holders of Sanofi
Appendix 4: 2014 first-quarter consolidated income statements
Appendix 5: R&D pipeline
Appendix 6: Definitions
12
Appendix 1: 2014 first-quarter consolidated net sales by geographic region and product
Q1 2014 Net Sales Total % CER % reported
Western
Europe % CER
United
States % CER
Emerging
Markets % CER
Rest of the
World % CER
Lantus 1,448 13.5% 8.2% 208 5.6% 951 14.5% 225 17.9% 64 8.8%
Apidra 75 19.7% 13.6% 23 21.1% 28 11.5% 17 28.6% 7 28.6%
Amaryl 86 0.0% -8.5% 6 0.0% 0 – 65 6.0% 15 -19.0%
Insuman 32 3.0% -3.0% 21 -4.5% 0 – 12 18.2% -1 –
Lyxumia 5 – – 3 – 0 – 0 – 2 –
Diabetes 1,662 13.2% 7.8% 275 8.3% 979 14.4% 320 16.1% 88 6.2%
Taxotere 69 -28.7% -36.1% 4 -50.0% 3 -72.7% 39 -23.2% 23 -18.2%
Jevtana (*) 66 30.8% 26.9% 38 58.3% 20 0.0% 7 14.3% 1 100.0%
Eloxatine 46 -15.3% -22.0% 1 -50.0% 1 -87.5% 30 -5.9% 14 6.7%
Thymoglobulin 52 22.7% 18.2% 8 0.0% 23 0.0% 18 90.0% 3 50.0%
Mozobil (*) 25 0.0% -3.8% 8 0.0% 13 -7.1% 3 0.0% 1 100.0%
Zaltrap (*) 16 45.5% 45.5% 7 600.0% 8 -20.0% 1 – 0 –
Other Oncology 70 19.7% 14.8% 16 0.0% 45 31.4% 7 -12.5% 2 100.0%
Oncology 344 0.8% -4.7% 82 22.4% 113 -5.7% 105 -4.2% 44 0.0%
Aubagio 78 305.0% 290.0% 17 – 59 205.0% 1 – 1 –
Lemtrada 5 – – 5 – 0 – 0 – 0 –
Cerezyme 168 5.8% -1.8% 59 3.5% 45 7.0% 56 10.0% 8 -9.1%
Myozyme 121 7.8% 4.3% 63 -6.1% 31 10.0% 20 64.3% 7 16.7%
Fabrazyme 98 13.0% 6.5% 25 25.0% 51 12.8% 9 -31.3% 13 66.7%
Aldurazyme 41 16.2% 10.8% 16 6.7% 7 14.3% 14 45.5% 4 -25.0%
Others 55 5.3% -3.5% 9 -9.1% 19 -9.5% 12 33.3% 15 18.8%
Genzyme 566 21.5% 14.8% 194 14.8% 212 31.0% 112 18.2% 48 19.6%
Plavix 487 18.2% 8.2% 62 -4.6% 0 – 204 4.4% 221 42.5%
Lovenox 416 1.4% -2.8% 229 7.5% 32 -32.7% 135 4.2% 20 0.0%
Aprovel 179 -22.8% -25.7% 54 -45.5% 4 33.3% 95 -1.0% 26 -27.8%
Renagel And Renvela 172 5.3% 0.6% 32 0.0% 114 -2.5% 22 92.3% 4 0.0%
Allegra 80 -46.2% -52.7% 3 50.0% 0 – 1 -96.6% 76 -37.0%
Stilnox 78 -14.9% -22.8% 11 0.0% 16 -10.5% 16 -10.0% 35 -21.6%
Depakine 92 -7.5% -13.2% 33 0.0% 0 – 56 -12.9% 3 33.3%
Synvisc / Synvisc One 70 -5.2% -9.1% 6 20.0% 53 -12.7% 8 50.0% 3 0.0%
Tritace 68 -9.0% -12.8% 32 -5.9% 0 – 34 -7.3% 2 -66.7%
Multaq (*) 73 21.0% 17.7% 10 0.0% 60 26.5% 2 0.0% 1 0.0%
Lasix 36 -5.0% -10.0% 20 11.1% 1 0.0% 12 16.7% 3 -66.7%
Targocid 37 -9.3% -14.0% 20 -9.1% 0 – 15 -5.6% 2 -33.3%
Orudis 35 14.3% 0.0% 5 -16.7% 0 – 29 21.4% 1 0.0%
Cordarone 32 0.0% -8.6% 6 0.0% 0 – 18 5.3% 8 -10.0%
Xatral 24 -3.8% -7.7% 10 11.1% 0 -100.0% 14 14.3% 0 -200.0%
Actonel 21 -17.9% -25.0% 4 -16.7% 0 – 11 -20.0% 6 -14.3%
Auvi-Q / Allerject (*) 10 25.0% 25.0% 1 0.0% 8 33.3% 0 – 1 0.0%
Other Rx Drugs 909 -10.9% -15.8% 407 -6.5% 98 -22.8% 320 -11.3% 84 -12.6%
Total Other Rx Drugs 2,819 -5.7% -11.3% 945 -6.1% 386 -10.2% 992 -4.5% 496 -3.8%
Consumer Healthcare 885 18.6% 9.1% 200 0.0% 201 18.1% 435 34.8% 49 -13.4%
Generics 421 8.0% -0.5% 139 0.0% 28 -46.3% 244 23.6% 10 100.0%
Pharmaceuticals 6,697 4.7% -1.6% 1,835 0.0% 1,919 7.2% 2,208 8.6% 735 -1.2%
Polio Pertussis 211 -15.9% -21.9% 6 0.0% 76 90.5% 92 -32.9% 37 -43.4%
Influenza Vaccines 135 19.3% 13.4% 0 – 21 40.0% 105 17.2% 9 9.1%
Meningite/Pneumonie 56 -25.0% -30.0% 0 -100.0% 38 -4.8% 15 -54.3% 3 100.0%
Adult Booster Vaccines 81 0.0% -4.7% 8 -42.9% 64 15.5% 7 -12.5% 2 -40.0%
Travel And Other Andemics Vaccines 75 10.8% 1.4% 5 0.0% 15 6.7% 41 7.1% 14 33.3%
Other Vaccines 70 4.3% 1.4% 2 – 65 6.3% 1 0.0% 2 -100.0%
Vaccines 628 -4.2% -9.9% 21 -19.2% 279 23.8% 261 -15.0% 67 -28.4%
Fipronil 171 -8.2% -12.8% 62 -1.6% 75 -21.8% 22 13.6% 12 36.4%
Nexgard 23 – – 1 – 22 – 0 – 0 –
Vaccines 154 -1.2% -6.1% 42 -2.3% 34 6.1% 75 -3.6% 3 0.0%
Avermectines 114 -14.8% -19.7% 16 0.0% 67 -23.1% 12 16.7% 19 -8.7%
Others 55 11.5% 5.8% 21 4.8% 19 25.0% 12 27.3% 3 -25.0%
Animal Health 517 -1.6% -6.7% 142 0.0% 217 -6.2% 121 3.9% 37 2.4%
Total Group 7,842 3.5% -2.7% 1,998 -0.3% 2,415 7.5% 2,590 5.5% 839 -4.0%
13
Appendix 2: Business net income statement
* 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 1,319.9 million in the first quarter of 2014 and 1,322.2 million in the first quarter of 2013.
(1) Including impact of transition to IFRIC 21.
First quarter Group Total Pharmaceuticals Vaccines Animal Health Others
€ million Q1 2014 Q1 2013(1) Change Q1 2014 Q1 2013(1) Change Q1 2014 Q1 2013(1) Change Q1 2014 Q1 2013(1) Change Q1 2014 Q1 2013(1)
Net sales 7,842 8,059 (2.7%) 6,697 6,808 (1.6%) 628 697 (9.9%) 517 554 (6.7%)
Other revenues 83 98 (15.3%) 68 83 (18.1%) 7 7 – 8 8 –
Cost of sales (2,516) (2,545) (1.1%) (1,988) (2,034) (2.3%) (350) (345) 1.4% (178) (166) 7.2%
As % of net sales (32.1%) (31.6%) (29.7%) (29.9%) (55.7%) (49.5%) (34.4%) (29.9%)
Gross profit 5,409 5,612 (3.6%) 4,777 4,857 (1.6%) 285 359 (20.6%) 347 396 (12.4%)
As % of net sales 69.0% 69.6% 71.3% 71.3% 45.4% 51.5% 67.1% 71.5%
Research and development
expenses (1,139) (1,157) (1.6%) (995) (990) 0.5% (107) (128) (16.4%) (37) (39) (5.1%)
As % of net sales (14.5%) (14.4%) (14.9%) (14.5%) (17.0%) (18.4%) (7.2%) (7.0%)
Selling and general
expenses (2,078) (2,140) (2.9%) (1,791) (1,836) (2.5%) (129) (141) (8.5%) (158) (163) (3.1%)
As % of net sales (26.5%) (26.6%) (26.7%) (27.0%) (20.6%) (20.2%) (30.5%) (29.5%)
Other current operating
income/expenses (25) 29 (23) 30 (2) 2 6 (1) (6) (2)
Share of profit/loss of
associates* and joint
ventures
13 18 8 19 5 (1)
Net income attributable to
non-controlling interests (35) (41) (35) (41)
Business operating income 2,145 2,321 (7.6%) 1,941 2,039 (4.8%) 52 91 (42.9%) 158 193 (18.1%) (6) (2)
As % of net sales 27.4% 28.8% 29.0% 30.0% 8.3% 13.1% 30.6% 34.8%
Financial income and
expenses (76) (140)
Income tax expense (522) (583)
Tax rate** 25.0% 26.5%
Business net income 1,547 1,598 (3.2%)
As % of net sales 19.7% 19.8%
Business earnings per
share*** (in euros) 1.17 1.21 (3.3%)
14
Appendix 3: Reconciliation of Business net income to Net income attributable to equity holders
of Sanofi
(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:
€657 million in the first quarter of 2014 and €749 million in the first quarter of 2013.
(3) Day one profit on Alnylam shares presented in financial result.
(4) Based on an average number of shares outstanding of 1,319.9 million in the first quarter of 2014 and 1,322.2
million in the first quarter of 2013.
See page 10 for comments on the reconciliation of business net income to consolidated net income.
€ million Q1 2014 Q1 2013(1) Change
Business net income 1,547 1,598 (3.2%)
Amortization of intangible assets (2) (677) (775)
Impairment of intangible assets (3) (10)
Fair value remeasurement of contingent
consideration liabilities (8) (41)
Expenses arising from the impact of acquisitions on
inventories – (3)
Restructuring costs (51) (54)
Other gains and losses, litigation 35(3) –
Tax effect of items listed above: 248 280
Amortization of intangible assets 244 259
Impairment of intangible assets 1 –
Fair value remeasurement of contingent
consideration liabilities 1 4
Expenses arising from the impact of acquisitions on
inventories – 1
Restructuring costs 15 16
Other gains and losses, and litigations (13) –
Share of items listed above attributable to non-controlling
interests
1 1
Restructuring costs of associates and joint ventures, and
expenses arising from the impact of acquisitions on
associates and joint ventures
(8) (7)
Net income attributable to equity holders of Sanofi 1,084 989
Consolidated earnings per share(4) (in euros) 0.82 0.75 9.3%
15
Appendix 4: Consolidated income statement
€ million Q1 2014 Q1 2013(1)
Net sales 7,842 8,059
Other revenues 83 98
Cost of sales (2,516) (2,548)
Gross profit 5,409 5,609
Research and development expenses (1,139) (1,157)
Selling and general expenses (2,078) (2,140)
Other operating income 10 71
Other operating expenses (35) (42)
Amortization of intangible assets (677) (775)
Impairment of intangible assets (3) (10)
Fair value remeasurement of contingent consideration
liabilities (8) (41)
Restructuring costs (51) (54)
Other gains and losses, and litigation – –
Operating income 1,428 1,461
Financial expense (147) (157)
Financial income 106 17
Income before tax and associates and joint ventures 1,387 1,321
Income tax expense (274) (303)
Share of profit/loss of associates and joint ventures 5 11
Net income 1,118 1,029
Net income attributable to non-controlling interests 34 40
Net income attributable to equity holders of Sanofi 1,084 989
Average number of shares outstanding (million) 1,319.9 1,322.2
Earnings per share (in euros) 0.82 0.75
(1) Including impact of transition to IFRIC 21.
16
Appendix 5: R&D Pipeline
Registration
Lemtrada (alemtuzumab)
Anti-CD52 mAb
Multiple sclerosis, U.S.
N
Cerdelga (eliglustat tartrate)
Glucosylceramide synthetase inhibitor
Gaucher disease, U.S., EU
Quadracel
Diphtheria, tetanus, pertussis
& polio vaccine; 4-6 y of age
Fluzone QIV ID
Quadrivalent inactivated
influenza vaccine intradermal
Phase III
N
Toujeo (U300)
Insulin glargine
Type 1+2 diabetes
N
alirocumab
Anti-PCSK-9 mAb
Hypercholesterolemia
Dengue
Mild-to-severe
dengue fever vaccine
N
Lyxumia (lixisenatide)
GLP-1 agonist
Type 2 diabetes, U.S.
Kynamro (mipomersen)
Apolipoprotein B-100 antisense
Severe HeFH, U.S.
Clostridium difficile
Toxoid vaccine
LixiLan
lixisenatide + insulin glargine
Fixed-Ratio / Type 2 diabetes
N
sarilumab
Anti-IL-6R mAb
Rheumatoid arthritis
DTP-HepB-Polio-Hib (PR5I)
Pediatric hexavalent vaccine
N
patisiran SAR438037
mRNA inhibitor
Familial amyloid polyneuropathy
Jevtana (cabazitaxel)
Metastatic prostate cancer (1L)
VaxiGrip QIV IM
Quadrivalent inactivated
influenza vaccine
SYNVISC-ONE
Medical device
Pain in hip OA
Phase II
N
dupilumab
Anti-IL4Rα mAb
Atopic dermatitis; Asthma; Nasal polyposis
N
SAR391786
GDF8 mAb
Sarcopenia
N
SAR438714 (ALN-TTRsc)
RNAi
Familial amyloid cardiomyopathy
N
SAR339658
Anti-VLA 2 mAb
Multiple sclerosis
N
SAR3419
Maytansin-loaded anti-CD19 mAb
B-cell refractory/relapsed malignancies
(NHL)
Rotavirus
Live attenuated tetravalent
Rotavirus oral vaccine
N
SAR156597
IL4/IL13 Bi-specific mAb
Idiopathic pulmonary fibrosis
N
SAR256212 (MM121)
anti-ErbB3 mAb
Breast cancer (2L, 3L)
Rabies VRVg
Purified vero rabies vaccine
N
SAR100842
LPA-1 receptor antagonist
Systemic sclerosis
N
Combination
SAR245409 (XL765) / MSC1936369B
Oral dual inhibitor of PI3K & mTOR / pimasertib
Ovarian cancer
Meninge ACYW conj.
2nd generation meningococcal
conjugate infant vaccine
sarilumab
Anti-IL-6R mAb
Uveitis
N
SAR279356 (F598)
Anti-PNAG mAb
Serious infections
Tuberculosis
Recombinant subunit vaccine
N
fresolimumab
TGFβ antagonist
Focal segmental glomerulosclerosis
N
Combination
ferroquine / OZ439
Antimalarial
Malaria
17
Phase I
N
SAR650984
Anti-CD38 naked mAb
Hematological malignancies
N
SAR228810
Anti-protofibrillar AB mAb
Alzheimer’s disease
N
GZ402665
(rhASM)
Niemann-Pick type B
N
SAR405838 (MI-773)
HDM2 / p53 antagonist
Solid tumors
N
SAR252067
Anti-LIGHT mAb
Crohn’s disease
N
GZ402671
Oral GCS Inhibitor
Fabry Disease
N
SAR153192
Anti-DLL4 mAb
Solid tumors
N
SAR113244
Anti-CXCR5 mAb
Systemic lupus erythematosus
N
GZ402666
neo GAA
Pompe Disease
N
SAR566658
Maytansin-loaded anti-CA6 mAb
Solid tumors
Insulin Biosimilar Program
Diabetes
Streptococcus pneumonia
Meningitis & pneumonia vaccine
N
SAR125844
C-MET kinase inhibitor
Solid tumors
N
GZ402663 (sFLT-01)
Gene therapy
Age-related macular degeneration (AMD)
Pseudomonas aeruginosa
Antibody fragment product
Prevention of ventilator-associated pneumonia
N
SAR307746
Anti-ANG2 mAb
Solid tumors
N
StarGen
Gene therapy
Stargardt disease
Herpes Simplex Virus Type 2
HSV-2 vaccine
N
SAR260301
PI3K β selective inhibitor
PTEN – Deficient tumors
N
UshStat
Gene therapy
Usher syndrome 1B
N
SAR245408 (XL147)
Oral PI3K inhibitor
Solid tumors
N
SAR438151
undisclosed target
Combination
SAR405838 / MSC1936369B
Solid tumors
N
SAR438584
undisclosed target
N: New Molecular Entity Immune Mediated Diseases
Rare Diseases
Oncology
Diabetes Solutions
Vaccines
Infectious Diseases
Cardiovascular / Renal
Diseases
Age Related
Degenerative Diseases
Ophthalmology
Biosurgery
18
Appendix 6: 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 first quarter of 2013
€ million Q1 2014
Net sales 7,842
Effect of exchange rates 497
Net sales at constant exchange rates 8,339
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.
The effects of major tax disputes, the tax on dividends distributed to Sanofi shareholders
(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.
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