On April 28, 2017 Sanofi reported financial results for the quarter ended March 31, 2017 (Press release, Sanofi, APR 28, 2017, View Source [SID1234518740]).

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Q1 2017 sales growth supported by Specialty Care, Vaccines and Emerging Markets

Net sales were €8,648 million, up 11.1% on a reported basis and 8.6%(4) at CER reflecting the acquisition of Boehringer Ingelheim’s (BI) CHC business and full consolidation of Sanofi’s European vaccine operations. At constant structure and CER, net sales were up 3.5%.
Sanofi Genzyme (Specialty Care) GBU sales increased 15.5% at CER driven by Multiple Sclerosis products.
Diabetes and Cardiovascular GBU sales were down 7.7% at CER; Global Diabetes franchise sales decreased 6.0%.
Sanofi Pasteur GBU grew 13.2% at CER and constant structure due to the strong performance of pediatric combinations.
CHC GBU sales were up 4.7% at CER and constant structure driven by the performance in Europe.
Emerging Markets(5) sales increased 8.5% at CER and constant structure.

Strong financial results and 2017 guidance confirmed

Business operating income of €2,442 million, up 7.6% at CER and constant structure.
Business EPS(2) grew 3.0% at CER to €1.42 and increased 6.0% on a reported basis.
Sanofi continues to expect 2017 Business EPS(2) to be stable to -3%(6) at CER, barring unforeseen major adverse events.
IFRS net income of €5,701 million (up 424%) included a net gain of €4,427 million resulting from the divestment of Merial.

Sanofi progresses on its 2020 roadmap

Integration of Boehringer Ingelheim CHC business on track, enhancing Sanofi’s position in key categories and regions.
Following the termination of the SPMSD JV, European vaccine business now fully driven by Sanofi.
Dupixent, a breakthrough therapy for moderate-to-severe atopic dermatitis, now available to adult patients in the U.S.
Soliqua100/33, first once-daily fixed combination of Lantus and lixisenatide for type-2 diabetes, launched in the U.S.
Kevzara BLA for the treatment of rheumatoid arthritis granted PDUFA date of May 22, 2017.
FDA approval of Xyzal Allergy 24H for OTC use and launch underway ahead of the U.S. spring allergy season.


Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"We have started the year with robust growth driven by Specialty Care and Vaccines as well as good performance in Emerging Markets. Our top line in the first quarter also benefited from the integration of the Boehringer Ingelheim CHC and European vaccine businesses. At the same time, the simplified organization continues to contribute to Sanofi’s financial performance. The U.S. launch of Dupixent for moderate-to-severe atopic dermatitis marks a key innovation milestone on our strategic roadmap and lays the foundation for our new immunology franchise. We are excited to bring this highly innovative medicine to patients suffering from this devastating disease".

(1) CS: constant structure: adjusted for BI CHC business, termination of SPMSD and others; (2) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (see Appendix 8 for definitions). The consolidated income statement for Q1 2017 is provided in Appendix 3 and a reconciliation of IFRS net income reported to business net income is set forth in Appendix 4; (3) The closing of the disposal of Merial in Mexico is expected in 2017; (4) changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8); (5) See page 7; (6) 2016 Business EPS was €5.68

Investor Relations: (+) 33 1 53 77 45 45 – E-mail: [email protected] – Media Relations: (+) 33 1 53 77 46 46 – E-mail: [email protected]
Website: www.sanofi.com Mobile app: SANOFI IR available on the App Store and Google Play

2017 first-quarter Sanofi sales
Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(7).
In the first quarter of 2017, Company sales were €8,648 million, up 11.1% on a reported basis. Exchange rate movements had a favorable effect of 2.5 percentage points reflecting mainly the positive evolution of the U.S. dollar, Brazilian Real and Japanese Yen which more than offset the negative impact from the Egyptian Pound, Turkish Lira and British Pound. Company sales benefited from the acquisition of BI’s CHC business and full consolidation of Sanofi’s European vaccines operations leading to an increase of 8.6% at CER. At CER and constant structure, Company sales were up 3.5%.

Global Business Units
The table below presents sales by Global Business Unit (GBU) and reflects the organization of Sanofi which became effective as of January 1, 2016. This structure drives deeper specialization, simplifies reporting and provides clear focus on growth drivers. Please note that in Emerging Markets, Specialty Care and Diabetes and Cardiovascular sales are included in the General Medicines and Emerging Markets GBU.

Net Sales by GBU
(€ million)
Q1 2017
Change
(CER)
Change
at CER/CS*
Sanofi Genzyme (Specialty Care)(a)
1,379
+15.5%
+15.5%
Diabetes and Cardiovascular(a)
1,419
-7.7%
-7.7%
General Medicines & Emerging Markets(b)
3,725
+2.2%
+2.1%
Consumer Healthcare (CHC)
1,341
+42.7%
+4.7%
Total Pharmaceuticals
7,864
+7.4%
+2.6%
Sanofi Pasteur (Vaccines)
784
+22.2
+13.2%
Total Company sales
8,648
+8.6%
+3.5%
(a) Does not include Emerging Markets sales- see definition page 7; (b) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care;
*CS : constant structure

Global Franchises
The table below presents first quarter 2017 sales by global franchise, including Emerging Markets sales, to facilitate comparisons. Appendix 1 provides a reconciliation of sales by GBU and franchise.
Net sales by Franchise
(€ million)
Q1 2017
Change
(CER)
Change
at CER/CS*
Developed
Markets
Change
at CER/CS*
Emerging
Markets
Change
at CER/CS*
Specialty Care
1,620
+15.6%
+15.6%
1,379
+15.5%
241
+16.3%
Diabetes and Cardiovascular
1,795
-4.0%
-4.0%
1,419
-7.7%
376
+12.3%
Established Rx Products
2,640
+0.6%
+0.3%
1,634
-4.1%
1,006
+8.3%
Consumer Healthcare (CHC)
1,341
+42.7%
+4.7%
937
+6.1%
404
+1.3%
Generics
468
-2.0%
-1.7%
268
-5.0%
200
+3.4%
Vaccines
784
+22.2%
+13.2%
468
+14.6%
316
+11.1%
Total net sales
8,648
+8.6%
+3.5%
6,105
+1.6%
2,543
+8.5%
*CS : constant structure
Pharmaceuticals
First-quarter Pharmaceuticals sales increased 7.4% to €7,864 million. At constant structure, Pharmaceuticals sales were up 2.6% driven by Multiple Sclerosis, CHC, Rare Disease, Oncology and Cardiovascular franchises.
(7) See Appendix 8 for definitions of financial indicators.

Rare Disease franchise
Net sales (€ million)
Q1 2017
Change
(CER)
Myozyme / Lumizyme
190
+12.7%
Cerezyme
176
-4.9%
Fabrazyme
177
+15.4%
Aldurazyme
52
+8.3%
Cerdelga
31
+30.4%
Others
86
+3.8%
Total Rare Diseases
712
+7.6%

In the first quarter, Rare Disease sales increased 7.6% to €712 million driven by the accrual of patients worldwide. Rare Disease sales grew at double digits in the U.S. and Emerging Markets, up 12.2% and 11.1%, respectively.

In the first quarter, Gaucher (Cerezyme and Cerdelga) sales decreased 1.0% to €207 million, due to lower Cerezyme sales in Emerging Markets (down 10.7% to €50 million) mostly driven by ordering patterns in Latin America. Cerdelga sales increased 30.4% to €31 million of which €25 million were generated in the U.S. (up 26.3%).

First-quarter Fabrazyme sales were up 15.4% to €177 million, reflecting a continued accrual of new Fabry patients.
Myozyme/Lumizyme sales increased 12.7% to €190 million in the first quarter, mainly due to new patient accruals and increased worldwide diagnosis of Pompe disease.

Multiple Sclerosis franchise
Net sales (€ million)
Q1 2017
Change
(CER)
Aubagio
371
+29.7%
Lemtrada
125
+40.9%
Total Multiple Sclerosis
496
+32.4%

First-quarter Multiple Sclerosis (MS) sales increased 32.4% to €496 million, reflecting strong Aubagio and Lemtrada performance in the U.S. and Europe.

In the first quarter, Aubagio sales increased 29.7% to €371 million driven by the U.S. (up 33.0% to €259 million) and Europe (up 23.0% to €91 million). In the U.S., Aubagio has achieved market share of 9.0% (source IMS TRX-Q1 2017) and is now the most "switched to" disease modifying therapy in the U.S. (source IMS NPA Market Dynamics).

First-quarter Lemtrada sales increased 40.9% to €125 million, including €67 million in the U.S. (up 39.1%) and €45 million in Europe (up 31.4%).

Oncology franchise
Net sales (€ million)
Q1 2017
Change
(CER)
Jevtana
97
+5.6%
Thymoglobulin
72
+7.7%
Taxotere
47
+2.2%
Eloxatin
45
+7.1%
Mozobil
40
+11.4%
Zaltrap
16
-5.9%
Others
95
+46.0%
Total Oncology
412
+12.8%

First-quarter Oncology sales increased 12.8% to €412 million driven mainly by Jevtana and boosted by a U.S. government order for Leukine. Jevtana sales were up 5.6% to €97 million in the first quarter led by Europe (up 5.7% to €37 million) and Japan. In the first quarter, Thymoglobulin sales increased 7.7% to €72 million supported by the U.S. (up 8.1% to €41 million).

Eloxatin sales increased 7.1% to €45 million in the first quarter supported by China (Emerging Markets sales were up 27.6% to €37 million) which offset generic competition in Canada. First-quarter Taxotere sales increased 2.2% (to €47 million) driven by Emerging Markets (up 23.3% to €37) which offset continued generic competition in Japan.

Diabetes franchise
Net sales (€ million)
Q1 2017
Change
(CER)
Lantus
1,226
-14.1%
Toujeo
192
+78.6%
Total glargine
1,418
-7.7%
Apidra
98
+14.1%
Amaryl
89
+5.7%
Insuman
27
-15.6%
BGM (Blood Glucose Monitoring)
17
–
Lyxumia
7
-22.2%
Soliqua
4
–
Total Diabetes
1,663
-6.0%

In the first quarter, Diabetes sales decreased 6.0% to €1,663 million, including lower Lantus sales in the U.S. First-quarter U.S. Diabetes sales were down 14.7% to €839 million. Sales in Emerging Markets increased 12.1% to €373 million. Sales in Europe were €326 million, a decrease of 3.0%.

In the first quarter, Sanofi glargine (Lantus and Toujeo) sales decreased 7.7% to €1,418 million. In the U.S., Sanofi glargine sales of €805 million were down 15.5% and reflected the impact of the exclusion from various CVS commercial formularies. The U.S. Diabetes sales decline is expected to accelerate over the remainder of the year primarily due to the United Health formulary exclusion which started April 1, 2017 as well as an incremental impact from the CVS formulary exclusion. In Europe, Sanofi glargine sales decreased 3.1% to €245 million due to biosimilar competition in several European markets.

Over the quarter, Lantus sales were €1,226 million down 14.1%. In the U.S., Lantus sales decreased 20.9% to €690 million mainly reflecting lower average net price and patients switching to Toujeo as well as the aforementioned impact of formulary exclusions. In Europe, first-quarter Lantus sales were €199 million (down 14.8%) due to biosimilar competition and patients switching to Toujeo. In Emerging Markets, sales were up 9.6% to €253 million.

First-quarter Toujeo sales were €192 million (up 78.6%) of which €115 million (up 42.3%) were recorded in the U.S. and €46 million in Europe.

Amaryl sales were €89 million, up 5.7% in the first quarter, of which €73 million were generated in Emerging Markets (up 8.5%).

First-quarter Apidra sales increased 14.1% to €98 million, reflecting double digit growth in the U.S. (up 12.0% to €29 million), Europe (up 12.9% to €35 million), and Emerging Markets (up 20.0% to €24 million).

Since January 2017, Soliqua 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection; lixisenatide was in-licensed from Zealand Pharma) has been available in the U.S. Soliqua sales were €4 million in the first quarter.

Cardiovascular franchise
First-quarter Praluent sales (collaboration with Regeneron) were €34 million of which €24 million was in the U.S. and €8 million in Europe. This reflected significant payer utilization management restrictions in the U.S. and limited market access in Europe.

In January 2017, the U.S. District Court for the District of Delaware issued an injunction that required Sanofi and Regeneron to stop marketing, selling and manufacturing Praluent in the U.S. starting from February 21, 2017.

However, on February 8, 2017, the Court of Appeals for the Federal Circuit stayed (suspended) the permanent injunction for Praluent pending the companies’ appeal. As a result, Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent in the U.S. during the appeal process. The Court of Appeals is scheduled to hear oral arguments on June 6, 2017.

First-quarter Multaq sales were €98 million, up 10.5% reflecting 9.6% growth (to €83 million) in the U.S.
Established Rx Products
Net sales (€ million)
Q1 2017
Change
(CER)
Lovenox
415
+2.2%
Plavix
380
-1.8%
Renvela/Renagel
246
+2.1%
Aprovel/Avapro
193
+13.0%
Synvisc /Synvisc-One
90
-1.1%
Myslee/Ambien/Stilnox
73
-1.4%
Allegra
68
-13.3%
Other
1,175
-0.2%
Total Established Rx Products
2,640
+0.6%

In the first quarter, Established Rx Products sales increased 0.6% to €2,640 million, reflecting strong performance in Emerging Markets (up 8.2% to €1,006 million) which offset the impact of generic competition to Plavix in Japan. In the U.S., Established Rx Products sales decreased 4.9% (to €365 million). In Europe, Established Rx Products sales decreased 2.1% to €907 million.

Lovenox sales increased 2.2% to €415 million in the first quarter, driven by strong performance in Emerging Markets (up 14.3% to €120 million), which offset lower sales in Europe (down 1.5% to €257 million).
In the first quarter, Plavix sales were down 1.8% to €380 million due to generic competition in Japan that started in June 2015 (sales in Japan were down 33.7% to €64 million). In Emerging Markets, Plavix sales increased 10.8% to €262 million sustained by the performance in China.

First-quarter Renvela/Renagel sales increased 2.1% to €246 million. In the U.S. where Sanofi expects generic competition before the end of 2017, first-quarter sales were up 3.1% to €207 million. In Europe, Renvela/Renagel sales were down 13.6% to €18 million due to generic competition.
Aprovel/Avapro sales were up 13.0% (to €193 million) driven by product sales to our partner in Japan and sales in China.

Consumer Healthcare
CHC sales by geography and category are provided in Appendix 1.
Net sales (€ million)
Q1 2017
Change
(CER)
Change
at CER/CS*
Allergy Cough & Cold
414
+58.7%
+12.6%
of which Allegra
145
-0.7%
–
of which Mucosolvan
35
na
na
Pain
324
+45.1%
+10.2%
of which Doliprane
83
+7.8%
–
of which Buscopan
42
na
na
Digestive
229
+55.6%
-8.3%
of which Dulcolax
47
na
na
of which Enterogermina
47
+9.5%
–
of which Essentiale
35
-17.9%
–
of which Zantac
27
na
na
Nutritionals
164
+36.3%
-1.3%
of which Pharmaton
17
na
na
Other
210
+11.0%
+3.1%
of which Gold Bond
50
+2.1%
–
Total Consumer Healthcare
1,341
+42.7%
+4.7%
*CS : constant structure

In the first quarter, Consumer Healthcare (CHC) sales increased 42.7% to €1,341 million reflecting the closing of the acquisition of Boehringer Ingelheim CHC business on January 1st, 2017 and the transfer of some Sanofi products to the new Chinese joint-venture between Sanofi and China Resources Sanjiu (CR999). At constant structure, Sanofi CHC sales increased 4.7% in the first quarter mainly driven by the strong performance in Europe.

In Europe, CHC sales were up 68.2% to €406 million. At constant structure, sales were up 10.0%, due to an early cough and cold season. Over the period double-digit growth at constant structure was achieved by the Allergy Cough and Cold category (up 21.6%, driven by Mucosolvan, Bisolvon and Allegra) and the pain category (up 15.7% driven by Buscopan and Doliprane).

In the U.S., first quarter CHC sales increased 18.7% to €348 million. At constant structure, CHC sales were up 2.4% driven by the launch of Xyzal Allergy 24HR (sales of €43 million) which was approved in February as an over-the-counter treatment for the relief of symptoms associated with seasonal and year-round allergies. In the first quarter, the performance at constant structure of the Allergy, Cough and Cold (up 12.9%, driven by Xyzal launch) and Pain categories (up 16.7%) were partially offset by lower sales of the Digestive category (down 19.2%, impacted by lower sales of Dulcolax and Zantac).

In Emerging Markets, first-quarter CHC sales increased 20.9% to €404 million. At constant structure, CHC sales were up 1.3% reflecting lower sales in Russia which continued to be impacted by the economic environment. In Emerging Markets, the strong performance at constant structure of the Allergy Cough and Cold category (up 14.1%) was partially offset by lower sales of the Digestive category due to Essentiale.

In the rest of the world, CHC sales were up 151.5% to €183 million. At constant structure, CHC sales were up 4.9% mainly driven by the Nutritionals and Pain categories.

Generics
In the first quarter, Generics sales decreased 2.0% to €468 million reflecting lower sales in Europe (down 3.4% to €198 million), and a 2.8% increase in Emerging Markets (to €200 million).

As announced in our 2020 strategic roadmap, Sanofi has carefully reviewed all options for our Generics business in Europe and made the definitive decision to initiate a carve-out process expected to be completed by the end of 2018. Importantly, Sanofi confirms its commitment to Generics in other parts of the world with a greater focus on the Emerging Markets.
Vaccines
Net sales (€ million)
Q1 2017
Change
(CER)
Change
at CER/CS*
Polio/Pertussis/Hib vaccines
(incl. Pentacel, Pentaxim and Imovax)
432
+46.2%
+38.0%
Influenza vaccines
(incl. Vaxigrip and Fluzone)
38
+85.0%
+85.0%
Adult Booster vaccines (incl. Adacel )
79
-5.0%
-23.2%
Meningitis/Pneumonia vaccines
(incl. Menactra)
95
-24.6%
-24.6%
Travel and other endemic vaccines
106
+25.3%
+8.3%
Dengvaxia
17
-5.3%
-5.3%
Other vaccines
17
+23.1%
+14.3%
Total Vaccines (consolidated sales)
784
+22.2%
+13.2%
*CS : constant structure

First quarter consolidated Vaccines sales were up 22.2% to €784 million and reflected the termination of the Sanofi Pasteur MSD joint-venture in Europe from December 31, 2016. At constant structure, sales were up 13.2% mainly driven by the Polio/Pertussis/Hib (PPH) franchise. In the U.S., sales were up 13.5% to €287 million. In Emerging Markets, sales grew 11.5% to €316 million. In Europe, sales were up 110.4% to €100 million reflecting the termination of SPMSD JV. At constant structure, European sales were up 4.1%.

In the first quarter, Polio/Pertussis/Hib vaccines sales increased 46.2% to €432 million. At constant structure, PPH sales grew 38.0% reflecting supply recovery of Pentacel and CDC order phasing in the U.S. (U.S. Pentacel sales: €89 million versus €21 million in the first quarter of 2016), and increased release of Pentaxim batches in China.
Influenza vaccines sales were up 85.0% to €38 million boosted by supply to Butantan in Brazil in the first quarter.
First-quarter Adult Booster vaccines sales were €79 million, down 5.0%, or down 23.2% at constant structure impacted by Repevax supply disruption in Europe.

First quarter Dengvaxia sales were €17 million mainly reflecting the sales of the third dose for the public immunization program implemented in the Philippines at the beginning of 2016.

First-quarter Menactra sales were down 21.6% to €90 million mainly due to the U.S. CDC ordering pattern in the previous year.

First-quarter Travel and other endemic vaccines sales were €106 million up 25.3% and up 8.3% at constant structure.
Company sales by geographic region
Sanofi sales (€ million)
Q1 2017
Change
(CER)
Change
(CER/CS)
United States
2,764
+3.0%
+1.2%
Emerging Markets(a)
2,543
+11.3%
+8.5%
of which Latin America
676
+18.6%
+12.0%
of which Asia (including South Asia(b))
983
+13.4%
+12.4%
of which Africa, Middle East
546
+1.6%
-0.7%
of which Eurasia(c)
298
+14.3%
+9.9%
Europe(d)
2,411
+10.4%
+1.8%
Rest of the World(e)
930
+14.9%
+2.2%
of which Japan
529
+19.9%
-0.6%
Total Sanofi sales
8,648
+8.6%
+3.5%
*CS : constant structure

World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico
India, Bangladesh, Sri Lanka
Russia, Ukraine, Georgia, Belarus, Armenia and Turkey
Western Europe + Eastern Europe except Eurasia
Japan, South Korea, Canada, Australia, New Zealand, Puerto Rico
First-quarter sales in the U.S. were €2,764 million, an increase of 3.0% or 1.2% at constant structure driven mainly by the Multiple Sclerosis franchise (up 34.2%), Vaccines (up 13.5%), Oncology (up 23.1%), Rare Diseases (up 12.2%) and Cardiovascular (up 25.6%) which offset lower sales of Diabetes (down 14.7%).

First-quarter sales in Emerging Markets were €2,543 million, up 11.3% or 8.5% at constant structure driven by Established Rx products (up 8.3% at constant structure), Diabetes (up 12.1%), Vaccines (up 11.5%), Oncology (up 22.6%) and Rare Disease (up 11.1%). In Asia, first quarter sales were up 13.4% (up 12.4% at constant structure) to €983 million reflecting strong performance in China (up 17.0% at constant structure to €597 million), driven by Pharmaceuticals and also by the end of the vaccines market disruption. In Latin America, first quarter sales increased 18.6% (up 12.0% at constant structure) to €676 million sustained by Brazil. First-quarter sales in Brazil increased 24.5% at constant structure to €320 million supported by performance of Established Rx Products, Vaccines, generics and CHC. First-quarter sales in the Eurasia region increased 14.3% (9.9% at constant structure) to €298 million supported by strong growth in Turkey. Over the quarter, sales in Russia were €147 million up 0.9% and down 4.3% at constant structure impacted by local economic conditions. In Africa and the Middle East, sales were €546 million up 1.6% or down 0.7% at constant structure reflecting lower sales in Middle East due to phasing of vaccines supply and a modest growth in Africa.

First-quarter sales in Europe were €2,411 million, up 10.4% or 1.8% at constant structure, mainly driven by the performance of the Multiple Sclerosis franchise (up 25.7%) and CHC (up 10.0% at constant structure) which offset lower sales in Diabetes (down 3.0%) and Established Rx Products (down 3.1% at constant structure).
Sales in Japan increased 19.9% to €529 million in the first quarter. At constant structure, sales in Japan were down 0.6% impacted by generic Plavix competition which was partially offset by strong growth of vaccines sales.

R&D update
Consult Appendix 6 for full overview of Sanofi’s R&D pipeline
Regulatory update
Regulatory updates since the publication of 2016 full-year results on February 8, 2017 include the following:
In April, the FDA approved a new dosing regimen for Praluent of 300 mg administered subcutaneously once monthly (every 4 weeks).

In April the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for the marketing authorization of Kevzara (sarilumab), recommending its approval for use in adult patients with moderately to severely active rheumatoid arthritis.

In March, the U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab), the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Following successful conclusion of Le Trait manufacturing site inspection by FDA, the Kevzara (sarilumab) U.S. BLA was accepted in April for the treatment of rheumatoid arthritis with a PDUFA date of May 22, 2017.

At the end of April 2017, the R&D pipeline contained 46 pharmaceutical new molecular entities (excluding Life Cycle Management) and vaccine candidates in clinical development of which 13 are in Phase 3 or have been submitted to the regulatory authorities for approval.

Portfolio update
Phase 4:
Top-line results of the ODYSSEY OUTCOMES study on Praluent are now expected to be reported in the first quarter of 2018 based on communications from the independent DSMB (Data and Safety Monitoring Board). Recruitment for this 18,600-patient cardiovascular outcomes trial was completed in November 2015 and the scheduled two-year follow-up of patients is underway.

Phase 3:
The results of the CAFÉ study evaluating dupilumab in cyclosporine-resistant patients in moderate-to-severe atopic dermatitis were positive and demonstrated an acceptable safety profile. These results will be submitted to the EMA and presented at a scientific Congress.

In March, detailed results from the one-year Phase 3 CHRONOS study were presented at the Annual Meeting of the American Academy of Dermatology (AAD). In this study, patients receiving Dupixent with topical corticosteroids (TCS) achieved significantly improved measures of overall disease severity compared to TCS alone in adults with uncontrolled moderate-to-severe AD with a safety profile consistent with previous studies.

Phase 2:
SP0232 / MEDI8897 (partnership with MedImmune), a monoclonal antibody, entered the portfolio in Phase 2 for the prevention of lower respiratory tract illness in infants caused by respiratory syncytial virus.
SAR566658, a maytansin-loaded anti-CA6 monoclonal antibody, entered into Phase 2 for the treatment of triple negative breast cancer.

A Phase 2 study was initiated to evaluate isatuximab in acute lymphoblastic leukemia.
Phase 1:
SAR440181 / MYK491 (collaboration with MyoKardia), for the treatment of dilated cardiomyopathy (DCM1 myosin activation), entered Phase 1.

2017 first-quarter financial results(8)
Business Net Income(8)

In the first quarter of 2017, Sanofi generated sales of €8,648 million, an increase of 11.1% (up 8.6% at CER).
First-quarter other revenues increased 71.7% (up 66.9% at CER) to €249 million including VaxServe sales of non-Sanofi products of €173 million (versus €83 million in the first quarter of 2016).

First-quarter Gross Profit increased 13.1% to €6,200 million (up 10.6% at CER). At CER and constant structure*, Gross Profit increased 5.4%. The gross margin ratio improved by 1.3 percentage points to 71.7% versus the first quarter of 2016, mainly reflecting the positive impact of the growing Multiple Sclerosis business, a favorable product and geographical mix in our Established Rx Product franchise, as well as industrial productivity improvements. These impacts more than offset the negative U.S. Diabetes net price evolution. In the first quarter, the gross margin ratio of Pharmaceuticals was 73.1%, an improvement of 1.6 percentage points and the gross margin ratio of Vaccines decreased 0.6 percentage points to 58.0%. Sanofi expects its gross margin ratio to be approximately 70% at CER in 2017.

Research and Development expenses increased 6.0% to €1,309 million (up 4.0% at CER) in the first quarter. At CER and constant structure*, R&D expenses were up 2.1% reflecting the increased spending on our development programs in oncology (isatixumab, PD-1) and sotagliflozin.

First-quarter selling general and administrative expenses (SG&A) were up 12.0% to €2,478 million (up 9.5% at CER).
At CER and constant structure*, SG&A was up 1.5% mainly reflecting launch costs for Dupixent, Kevzara and Xyzal, commercial and marketing investments behind key Emerging countries and our Europe Vaccines business, as well as one-time costs associated with the integration of Boehringer Ingelheim CHC business. On the other hand, our Diabetes sales and marketing spending in the U.S. was adapted to the new competitive environment.

First-quarter other current operating income net of expenses was €34 million versus €93 million for the same period of 2016. In the first quarter of 2016, this line included an arbitration award of €192 million to Sanofi and also a foreign exchange loss related to Venezuela (€92 million).

The share of profits from associates was €30 million in the first quarter versus €23 million for the same period of 2016. The share of profits from associates included Sanofi’s share in Regeneron profit.

In the first quarter, non-controlling interests were -€35 million versus -€27 million in the first quarter of 2016.
First-quarter business operating income increased 15.0% to €2,442 million. At CER, business operating income increased 11.7%. At CER and constant structure*, business operating income increased 7.6%. The ratio of business operating income to net sales increased 0.9 percentage point to 28.2% versus the same period of 2016. In the first quarter, the business operating income ratio of Pharmaceuticals was 30.1%, 1.4 percentage points higher and the business operating income ratio of Vaccines increased 0.7 percentage points to 13.5%.

Net financial expenses were €63 million in the first quarter versus €117 million in the first quarter of 2016, reflecting mainly a lower cost of net debt.

First-quarter effective tax rate was 24.5% compared with 22.6% in the first quarter of 2016.
First-quarter business net income(8) increased 4.2% to €1,795 million (up 1.0% at CER). The ratio of business net income to net sales increased 0.9 percentage points to 20.8% versus the same period of 2016 (excluding Animal Health business).

In the first quarter of 2017, business earnings per share(8) (EPS) increased 6.0% to €1.42 on a reported basis and 3.0% at CER. The average number of shares outstanding was 1,262.4 million in the first quarter of 2017 versus 1,288.4 million in the first quarter of 2016.

(8) See Appendix 3 for 2017 first-quarter Consolidated income statement; see Appendix 8 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income.

* Adjusted for BI CHC business and termination of SPMSD

2017 guidance
Sanofi expects 2017 Business EPS to be stable to -3% at CER, barring unforeseen major adverse events, consistent with its previously announced Strategic Roadmap guidance for the 2016-17 period. Applying the average March 2017 exchange rates to the rest of the year, the currency impact on 2017 Business EPS is estimated to be +3% to +4%.
Reconciliation of IFRS net income reported to business net income (see Appendix 4)

In the first quarter of 2017, the IFRS net income was €5,701 million reflecting the acquisition of BI’s CHC business and full consolidation of Sanofi’s European vaccine operations. The main items excluded from the business net income were:
A net gain of €4,427 million resulting from the divestment of the Animal Health business (subject to post-closing adjustment).

\A €503 million amortization charge related to fair value remeasurement on intangible assets of acquired companies (primarily Aventis: €104 million, Genzyme: €231 million and BI CHC business €66 million) and to acquired intangible assets (licenses/products: €37 million). These items have no cash impact on the Company.

A charge of €36 million mainly reflecting an increase of Bayer contingent considerations linked to Lemtrada (charge of €21 million) and CVR fair value adjustment (charge of €16 million).

Expenses of €88 million arising from the impact of the acquisition of BI CHC business and the termination of SPMSD joint venture on inventories.

Restructuring costs and similar items of €119 million mainly related to the organizational transformation program at the industrial level in Europe and North America.

A €248 million tax effect arising from the items listed above, comprising €182 million of deferred taxes generated by amortization charged against intangible assets, €43 million associated with restructuring costs and similar items, €28 million associated with the impact of acquisition on inventories and €6 million associated with fair value remeasurement of contingent consideration liabilities.

An expense of €24 million net of tax related to restructuring costs of associates and joint-ventures, and expenses arising from the impact of acquisitions on associates and joint-ventures.

Capital Allocation
In the first quarter of 2017, net cash generated by operating activities was €954 million after capital expenditures of €382 million and an increase in working capital of €766 million. This net cash flow largely funded acquisitions and partnerships net of disposals (€222 million) and restructuring costs and similar items (€211 million). The swap between BI CHC business and Sanofi Animal Health business generated a net cash flow of €5,288 million (pre-tax amount as tax payments on the gain are expected in the next quarters), partially used to finance share repurchases (€1,289 million) over the quarter. As a consequence, net debt decreased from €8,206 million at December 31, 2016 to €3,685 million at March 31, 2017 (amount net of €14,924 million cash and cash equivalents).