EX-99.1 2 d591991dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

INFORMATION ON Q1 2018 FINANCIAL RESULTS

 

     Q1 2018      Change    

Change
at Constant Exchange

Rates

  

Net sales reported

    € 7,898m        -8.7 %      -0.4 % 

Net income reported

    € 1,016m        -82.2 %(1)      —    

Earnings per Share reported

    € 0.81        -82.0 %(2)      —    

Business net income(3)

    € 1,598m        -10.7 %      +0.4 % 

First-quarter 2018

 

•   Net sales were €7,898 million, down 8.7% on a reported basis, down 0.4%(4) at constant exchange rates (“CER”) and down 1.1% at constant scope (“CS”) and CER(5).

 

•   Sanofi Genzyme sales grew strongly, up 5.9% on a reported basis and 16.2% at CER(6), driven by contribution from the new immunology franchise.

 

•   Vaccines sales (-9.3% on a reported basis and -0.9% at CER) reflected strong performance in EU, offset by expected Pentaxim® supply constraint in China.

 

•   CHC sales were down on a reported basis (-6.9%) but grew 2.0% at CER supported by double-digit growth in Emerging Markets(7).

 

•   Diabetes and Cardiovascular GBU sales were down 23.4% on a reported basis and 15.7% at CER; global Diabetes franchise sales declined 10.0% at CER.

 

•   Emerging Markets sales(8) were down 3.1% on a reported basis and grew 8.3% at CER, driven by double-digit growth in China and Latin America

 

•   Announcement of a €1.5 billion share buyback program expected to be completed in mid-2019.

Specialty Care

 

•   Sanofi completed the acquisition of Bioverativ and consolidated its financial results from March 9, 2018.

 

•   First patient dosed with fitusiran, a novel RNAi therapeutic for hemophilia, in phase 3 ATLAS program.

 

•   Ablynx acquisition(9) will add caplacizumab for aTTP(10) (submitted in EU) and innovative Nanobody® platform.

R&D Update

 

•   Praluent® significantly reduced the risk of cardiovascular events in high risk patients in the ODYSSEY OUTCOMES study and was associated with a lower death rate.

 

•   Dupixent® supplemental BLA filed in the U.S., Japan and EU for moderate-to-severe asthma in adults and adolescents.

 

•   Cemiplimab filed in EU for metastatic cutaneous squamous cell carcinoma.

 

•   Sotagliflozin submitted in the U.S. and EU for type 1 diabetes.

2018 first-quarter Sanofi sales

In the first quarter of 2018, Company sales were €7,898 million, down 8.7% on a reported basis. Exchange rate movements had a negative effect of 8.3 percentage points mainly driven by the movement of the U.S. Dollar accompanied by the Brazilian Real, Chinese Yuan, Japanese Yen and Argentine Peso. At CER, Company sales decreased slightly (down 0.4%).

 

 

(1)  Excluding Animal Health gain on disposal, IFRS net income was down 19.9% and IFRS EPS was down 19.8%.
(2)  Excluding Animal Health gain on disposal, IFRS net income was down 19.9% and IFRS EPS was down 19.8%.
(3)  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 6 for definitions). The consolidated income statement for Q1 2018 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4.
(4)  See Appendix 6 for a discussion of CER.
(5)  CS is as adjusted for the Bioverativ acquisition.
(6)  Adjusted for Bioverativ acquisition: + 11.2% at CER/CS.
(7)  See definition below.
(8)  See definition below.
(9)  Subject to the completion of the acquisition.
(10)  Acquired thrombotic thrombocytopenic purpura.

 

1

Global Business Units

The table below presents sales by Global Business Unit (GBU). Please note that Emerging Markets sales for Specialty Care and Diabetes and Cardiovascular are included in the General Medicines and Emerging Markets GBU.

 

  Net Sales by GBU

  (€ million)

    Q1 2018      Change     Change
at CER		  

  Sanofi Genzyme (Specialty Care)(a)

      1,460        +5.9 %      +16.2 % 

  Diabetes and Cardiovascular(a)

      1,088        -23.4 %      -15.7 % 

  General Medicines & Emerging Markets(b)

      3,401        -9.1 %      -1.5 % 

  Total Pharmaceuticals

      5,949        -9.0 %      -0.9 % 

  Consumer Healthcare (CHC)

      1,238        -6.9 %      +2.0 % 

  Sanofi Pasteur (Vaccines)

      711        -9.3 %      -0.9 % 

  Total net sales

      7,898        -8.7 %      -0.4 % 

 

(a) Does not include Emerging Markets sales- see definition below; (b) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care.

Global Franchises

The tables below present first-quarter 2018 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 2018      Change     Change
at CER		    

Developed

Markets

      Change     Change
at CER		    

Emerging

Markets

      Change     Change
at CER		  

  Specialty Care

      1,710        +5.4 %      +16.3 %      1,460        +5.9 %      +16.2 %      250        +2.9 %      +16.9 % 

  Diabetes and Cardiovascular

      1,484        -17.3 %      -8.7 %      1,088        -23.4 %      -15.7 %      396        +5.6 %      +17.9 % 

  Established Rx Products

      2,320        -12.7 %      -6.4 %      1,327        -19.7 %      -16.1 %      993        -1.1 %      +9.7 % 

  Consumer Healthcare (CHC)

      1,238        -6.9 %      +2.0 %      829        -10.0 %      -3.5 %      409        +0.0 %      +14.4 % 

  Generics

      435        -6.7 %      +0.9 %      256        -3.8 %      -0.8 %      179        -10.5 %      +3.0 % 

  Vaccines

      711        -9.3 %      -0.9 %      471        +0.6 %      +10.9 %      240        -24.1 %      -18.4 % 

  Total net sales

      7,898        -8.7 %      -0.4 %      5,431        -11.1 %      -4.1 %      2,467        -3.1 %      +8.3 % 

Pharmaceuticals

First-quarter Pharmaceutical sales were down 9.0% on a reported basis and 0.9% at CER to €5,949 million primarily due to Diabetes and Established Rx Products.

Rare Disease franchise

 

  Net sales (€ million)    Q1 2018      Change    

Change

at CER

  

  Myozyme® / Lumizyme®

      196        +3.2 %      +11.1 % 

  Cerezyme®

      175        -0.6 %      +10.2 % 

  Fabrazyme®

      170        -4.0 %      +6.8 % 

  Aldurazyme®

      51        -3.8 %      +5.7 % 

  Cerdelga®

      36        +16.1 %      +25.8 % 

  Others Rare Diseases

      67        -23.0 %      -14.9 % 

  Total Rare Disease

      695        -2.7 %      +6.9 % 

In the first quarter of 2018, Rare Disease sales increased 6.9% at CER to €695 million, driven by Emerging Markets (up 20.8% at CER to €129 million) and Europe (up 7.4% at CER to €246 million). In the U.S., first-quarter Rare Disease sales grew 3.3% to €246 million.

First-quarter Gaucher (Cerezyme® and Cerdelga®) sales were up 12.6% at CER to €211 million, supported by the increasing penetration of Cerdelga® in the U.S. and Europe and the sustained growth of Cerezyme® in Emerging Markets. First-quarter Cerdelga® sales increased 25.8% at CER to €36 million, driven by Europe performance up 100% at CER (to €10 million).

 

2

First-quarter Myozyme®/Lumizyme® sales grew 11.1% at CER to €196 million, supported by positive trends in naïve patient accruals. First-quarter Myozyme®/Lumizyme® sales increased 14.6% at CER to €93 million in Europe and 10.4% at CER to €64 million in the U.S., respectively.

First-quarter Fabrazyme® sales grew 6.8% at CER to €170 million. First-quarter sales in the U.S. and Europe increased 6.5% at CER (to €86 million) and 5.0% at CER (to €42 million), respectively.

Multiple Sclerosis franchise

 

  Net sales (€ million)    Q1 2018      Change     Change
at CER		  

  Aubagio®

      371        0.0 %      +11.6 % 

  Lemtrada®

      105        -16.0 %      -8.8 % 

  Total Multiple Sclerosis

      476        -4.0 %      +6.5 % 

First-quarter Multiple Sclerosis (MS) sales grew 6.5% at CER to €476 million, driven by Aubagio®.

First-quarter Aubagio® sales increased 11.6% at CER to €371 million, supported by the U.S. (up 13.1% at CER to €254 million) and Europe (up 4.4% at CER to €95 million). In 2017, Sanofi reached settlement with all 20 generic Aubagio® ANDA first filers granting each a royalty-free license to enter the U.S. market on March 12, 2023.

In the first quarter, Lemtrada® sales decreased 8.8% at CER to €105 million due to lower U.S. sales (down 17.9% at CER to €47 million) reflecting increased competition as well as its unique dosing and durable effect. In Europe, Lemtrada® sales were up 4.4% at CER to €47 million.

Immunology franchise

 

  Net sales (€ million)    Q1 2018      Change      Change
at CER		  

  Dupixent®

      107        —          —    

  Kevzara®

      10        —          —    

  Total Immunology

      117        —          —    

Dupixent® (collaboration with Regeneron) was launched in the U.S. in April 2017 for the treatment of moderate-to-severe atopic dermatitis in adults, in Germany in December 2017 and in the Netherlands, Canada and Denmark during the first quarter of 2018. Dupixent® generated worldwide sales of €107 million in the first quarter, of which €95 million were in the U.S. Underlying demand in the U.S. remained strong with total prescriptions (source: IQVIA weekly TRx data) growing by 25% compared with the prior quarter. Sales evolution in the U.S. was impacted by trade inventory reduction as well as usual higher contribution to patient assistance programs in the beginning of the year (combined effect of approximately €30 million).

Kevzara® (collaboration with Regeneron) for rheumatoid arthritis was launched in the U.S. in June 2017 and in Germany, the UK and the Netherlands during the second half of last year. First-quarter Kevzara® sales were €10 million, of which €8 million were generated in the U.S. where commercial coverage of the product reached more than 80% of lives.

Rare Blood Disorder franchise

 

  Net sales (€ million)    Q1 2018      Change      Change
at CER		  

  Eloctate®

      43        —          —    

  Alprolix®

      21        —          —    

  Total Rare Blood Disorder

      64        —          —    

Sanofi announced the successful completion of its acquisition of Bioverativ, which was consolidated in the Company’s Financial Statements from March 9, 2018. Consolidated sales of the Rare Blood Disorder franchise were €64 million in the first quarter, including non U.S. sales of €13 million with Japan as the primary contributor. Following the market entry in Colombia in the first quarter of 2018, additional launches in Emerging Markets are expected this year.

 

3

Consolidated sales of Eloctate® (a recombinant antihemophilic Factor VIII, Fc Fusion Protein, indicated for the treatment of hemophilia A) were €43 million. Including the sales made by Bioverativ prior to consolidation in Sanofi’s results and compared to the first quarter of 2017, first-quarter Eloctate® sales growth was 27% at CER(11).

Consolidated sales of Alprolix® (a recombinant coagulation Factor IX, Fc Fusion Protein, indicated for the treatment of hemophilia B) were €21 million. Including the sales made by Bioverativ prior to consolidation in Sanofi’s results and compared to the first quarter of 2017, first-quarter Alprolix® sales growth was 12% at CER(12).

Oncology franchise

 

  Net sales (€ million)    Q1 2018      Change     Change
at CER		  

  Jevtana®

      99        +2.1 %      +10.3 % 

  Thymoglobulin®

      70        -2.8 %      +8.3 % 

  Eloxatin®

      44        -2.2 %      +6.7 % 

  Taxotere®

      43        -8.5 %      -2.1 % 

  Mozobil®

      38        -5.0 %      +5.0 % 

  Zaltrap®

      22        +37.5 %      +43.8 % 

  Others

      42        -55.8 %      -52.6 % 

  Total Oncology

      358        -13.1 %      -5.6 % 

First-quarter oncology sales decreased 5.6% at CER to €358 million. Consistent with the Company’s portfolio prioritization efforts, Sanofi sold Leukine® on January 31, 2018. Excluding Leukine®, oncology first-quarter sales were up 3.5% at CER.

Jevtana® sales were up 10.3% at CER to €99 million in the first quarter supported by the performance in the U.S. (up 17.5% at CER to €41 million). In the first quarter, Thymoglobulin® and Eloxatin® sales increased 8.3% at CER (to €70 million) and 6.7% at CER (to €44 million), respectively, with growth driven by China. First-quarter Zaltrap® sales increased 43.8% at CER to €22 million, driven by Japan.

Diabetes franchise

 

  Net sales (€ million)    Q1 2018      Change     Change
at CER		  

  Lantus®

      911        -25.9 %      -17.7 % 

  Toujeo®

      197        +4.2 %      +13.8 % 

  Total glargine

      1,108        -21.9 %      -13.5 % 

  Apidra®

      91        -7.1 %      +1.0 % 

  Amaryl®

      83        -6.7 %      +2.2 % 

  Insuman®

      24        -11.1 %      -7.4 % 

  BGM (Blood Glucose Monitoring)

      13        -23.5 %      -23.5 % 

  Lyxumia®

      5        -28.6 %      -14.3 % 

  Soliqua®

      9        +125.0 %      +175.0 % 

  Total Diabetes

      1,356        -18.5 %      -10.0 % 

In the first quarter, global Diabetes sales decreased at CER 10.0% to €1,356 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S. First-quarter U.S. Diabetes sales were down 26.6% at CER to €534 million, reflecting the previously announced changes in coverage in the Part D business and a continued decline in average U.S. glargine net prices. First-quarter sales in Emerging Markets increased at CER 17.7% to €392 million. First-quarter sales in Europe decreased 0.9% at CER to €323 million, despite Toujeo® growth.

In the first quarter, glargine (Lantus® and Toujeo®) sales decreased 13.5% at CER to €1,108 million. U.S. Sanofi glargine sales were down 28.7% at CER to €498 million, reflecting the aforementioned changes in coverage in Part D and a continued decline in average U.S. glargine net prices. In Europe, glargine sales increased 1.2% at CER to €248 million due to the Toujeo® strong performance, despite biosimilar glargine competition in several European markets.

 

(11)  Growth comparing full first-quarter 2018 sales versus full first-quarter 2017 sales, at constant exchange rate. Unaudited data.
(12)  Growth comparing full first-quarter 2018 sales versus full first-quarter 2017 sales, at constant exchange rate. Unaudited data.

 

4

In the first quarter, Lantus® sales were €911 million, down 17.7% at CER. In the U.S., Lantus® sales decreased 31.0% at CER to €413 million mainly reflecting lower average net price and the change in coverage in Sanofi’s Part D business.

In Europe, first-quarter Lantus® sales were €181 million (down 9.0% at CER) due to biosimilar glargine competition and patients switching to Toujeo®. In Emerging Markets, first-quarter Lantus® sales were up 8.6% at CER to €248 million.

First-quarter Toujeo® sales were €197 million, up 13.8% at CER. In the U.S., first-quarter Toujeo® sales were €85 million, down 14.8% at CER versus the first quarter of 2017. In Europe and Emerging Markets, first-quarter Toujeo sales were €67 million (up 45.7% at CER) and €28 million (versus €13 million in the first quarter of 2017).

Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) was launched in the U.S. in January 2017 and Suliqua™ was also launched in several European countries in 2017. Soliqua® 100/33 / Suliqua™ sales were €9 million in the first quarter of 2018.

Amaryl® sales were €83 million, up 2.2% at CER in the first quarter, of which €72 million were generated in Emerging Markets (up 9.7% at CER).

First-quarter Apidra® sales increased 1.0% at CER to €91 million. Lower sales in the U.S. (down 17.2% at CER to €21 million) were offset by strong growth in Emerging Markets (up 29.2% at CER to €27 million).

Cardiovascular franchise

First-quarter Praluent® sales (collaboration with Regeneron) increased 55.9% at CER to €49 million, of which €26 million was generated in the U.S. and €19 million in Europe. This reflected the continued significant payer utilization management restrictions in the U.S. and limited market access in Europe.

In March, Sanofi and Regeneron announced positive data from the ODYSSEY OUTCOMES study. Results showed that Praluent® significantly reduced the risk of cardiovascular events in high-risk patients. For the first time, adding a lipid-lowering therapy to maximally-tolerated statins was associated with a reduction of all-cause mortality(13). Sanofi and Regeneron also announced plans to make Praluent® more accessible and affordable for patients with the greatest health risk and unmet need.

First-quarter Multaq® sales were €79 million (down 9.2% at CER).

Established Rx Products

 

  Net sales (€ million)    Q1 2018      Change     Change
at CER		  

  Lovenox®

      391        -5.6 %      -0.7 % 

  Plavix®

      387        +1.8 %      +8.9 % 

  Renvela®/Renagel®

      101        -58.9 %      -54.1 % 

  Aprovel®/Avapro®

      172        -10.4 %      -3.1 % 

  Synvisc® /Synvisc-One®

      68        -24.4 %      -15.6 % 

  Myslee®/Ambien®/Stilnox®

      61        -16.4 %      -8.2 % 

  Allegra®

      52        -23.5 %      -16.2 % 

  Other

      1,088        -8.8 %      -2.5 % 

  Total Established Rx Products

      2,320        -12.7 %      -6.4 % 

In the first quarter, Established Rx Products sales decreased 6.4% to €2,320 million. This reflected generic competition to Renvela®/Renagel® (sevelamer) in the U.S., which more than offset strong growth in Emerging Markets (up 9.7% at CER to €993 million).

Lovenox® sales decreased 0.7% at CER to €391 million in the first quarter, reflecting increased competition in Europe (down 5.1% at CER to €244 million), which offset the growth in Emerging Markets (up 9.2% at CER to €115 million). Biosimilars are available in the UK, Germany and Italy.

 

(13)  HR=0.85; CI: 0.73-0.98; nominal p value = 0.026

 

5

In the first quarter, Plavix® sales were up 8.9% at CER to €387 million sustained by strong Emerging Markets performance (up 22.1% at CER to €297 million) driven by China. Sales in Japan were down 37.5% at CER to €37 million, reflecting generic competition.

First-quarter Renvela®/Renagel® (sevelamer) sales decreased 54.1% at CER to €101 million, due to generic competition in the U.S. (down 66.2% at CER to €61 million).

First-quarter Aprovel®/Avapro® sales decreased 3.1% at CER to €172 million, reflecting lower sales to Sanofi’s partner in Japan which offset the strong performance in China.

Consumer Healthcare

CHC sales by geography and category are provided in Appendix 1.

 

 Net sales (€ million)    Q1 2018      Change     Change
at CER		  

 Allergy Cough & Cold

      341        -16.2 %      -8.1 % 

of which Allegra®

      130        -9.7 %      +2.1 % 

of which Mucosolvan®

      27        -12.9 %      -6.5 % 

of which Xyzal®

      14        -67.4 %      -62.8 % 

 Pain

      324        -0.3 %      +8.9 % 

of which Doliprane®

      84        +1.2 %      +2.4 % 

of which Buscopan®

      54        +28.6 %      +45.2 % 

 Digestive

      248        +6.0 %      +15.0 % 

of which Dulcolax®

      53        +12.8 %      +23.4 % 

of which Enterogermina®

      49        +4.3 %      +12.8 % 

of which Essentiale®

      43        +7.5 %      +15.0 % 

of which Zantac®

      31        +14.8 %      +33.3 % 

 Nutritionals

      164        -5.7 %      +3.4 % 

 Other

      161        -15.3 %      -5.3 % 

of which Gold Bond®

      49        -2.0 %      +12.0 % 

 Total Consumer Healthcare

      1,238        -6.9 %      +2.0 % 

In the first quarter, Consumer Healthcare (CHC) sales increased 2.0% at CER to €1,238 million, sustained by Emerging Markets (up 14.4% at CER to €409 million) especially Latin America.

In Europe, first-quarter CHC sales were down 5.0% at CER to €382 million, due to a high base for comparison in the first quarter of 2017 which benefited from an early cough and cold season. As a consequence, first-quarter sales of Allergy Cough & Cold and Pain categories were down at CER 4.7% and 5.0%, respectively.

In the U.S., first-quarter CHC sales decreased 4.9% at CER to €287 million due to inventory build-up for the U.S. launch of Xyzal® Allergy 24HR in the prior year period as well as increased competition from private labels especially on intranasal spray allergy products.

In Emerging Markets, first-quarter CHC sales increased 14.4% at CER to €409 million driven by strong performance of Pain and Digestive categories (up 30.4% at CER and 23.7% at CER, respectively) mostly driven by Brazil and Argentina.

Generics

In the first quarter, Generics sales increased 0.9% at CER to €435 million, sustained by Emerging Markets sales (up 3.0% at CER to €179 million), partially offset by lower sales in Europe (down 6.1% at CER to €184 million). In April, Advent International and Sanofi entered into exclusive negotiations under which Advent would acquire Zentiva, Sanofi’s European generics business for an Enterprise Value of €1.9 billion. The transaction is expected to close by the end of 2018, subject to finalization of definitive agreements, completion of the appropriate social processes and approval of relevant regulatory authorities.

 

6

Vaccines

 

 Net sales (€ million)

 

   

Q1 2018

 

     

Change

 

    

 

Change
at CER

 

  

 

 Polio/Pertussis/Hib vaccines (incl. Hexaxim® / Hexyon® Pentacel®, Pentaxim® and Imovax®)

   

 

 

 

380

 

 

   

 

 

 

-12.0

 

% 

  

 

 

 

-4.6

 

% 

 Travel and endemic vaccines

      102        -3.8 %      +2.8 % 

 Adult Booster vaccines (incl. Adacel ®)

      92        +16.5 %      +26.6 % 

 Meningitis/Pneumonia vaccines (incl. Menactra®)

      89        -6.3 %      +7.4 % 

 Influenza vaccines (incl. Vaxigrip®, Fluzone HD® & Fluzone®)

      29        -23.7 %      -15.8 % 

 Other vaccines (including Dengvaxia®)

 

     

 

 19

 

  

 

     

 

 -44.1

 

 % 

 

    

 

 -35.3

 

 % 

 

 

 Total Vaccines

 

   

 

 

 

 

711

 

 

 

 

   

 

 

 

 

-9.3

 

 

% 

 

  

 

 

 

 

-0.9

 

 

% 

 

First-quarter Vaccines performance was impacted as expected by the constrained supply of Pentaxim® in China and low sales of Dengvaxia® (€1 million versus €17 million in the first quarter of 2017) following the announced label update in November 2017. As a consequence, first-quarter Vaccines sales slightly decreased by 0.9% at CER to €711 million and declined by 18.4% at CER to €240 million in Emerging Markets. In the U.S., first-quarter Vaccines sales increased 4.2% at CER to €259 million. In Europe, first-quarter Vaccines sales were up 38.0% at CER to €137 million driven by Polio/Pertussis/Hib and Boosters franchises.

As previously communicated, Vaccines GBU sales are expected to be lower in the first half of 2018 due to continued supply constraints of Pentaxim® in China and a high base for comparison on Menactra® in the second quarter.

In the first quarter, Polio/Pertussis/Hib (PPH) vaccines sales decreased 4.6% at CER to €380 million, impacted by the anticipated constrained supply of Pentaxim® in China. Consequently, PPH sales in Emerging Markets decreased 17.6% at CER to €157 million despite good performance of the pediatric AcXim combination family in some other countries. In Europe, PPH sales were up 26.3% at CER to €71 million, driven by the success of Hexyon®, our ready to use 6-in-1 pediatric vaccine.

First-quarter Travel and endemic vaccines sales were €102 million up 2.8% at CER.

First-quarter Adult Booster vaccines sales increased 26.6% at CER to €92 million driven by strong performance in Europe (up 117.6% at CER to €37 million) which reflected the end of Repevax® supply constraint. In the U.S, Adult Booster sales increased 4.4% at CER to €41 million.

First-quarter Menactra® sales increased 13.3% at CER to €89 million with 8.5% sales growth at CER in the U.S.

First-quarter Influenza vaccines sales were €29 million (down 15.8% at CER) due to a delay of the Southern Hemisphere campaign delivery.

In April, Sanofi announced that it is investing €350 million for the construction of a new state-of-the-art vaccine manufacturing facility in Toronto. The new facility is designed to allow Sanofi Pasteur to meet the growing demand for five-component acellular pertussis (5-acP) antigen. Upon completion in 2021, the new building will also be equipped to produce the antigens used in the diphtheria and tetanus vaccines.

Company sales by geographic region

 

 

 Sanofi sales (€ million)

 

   

 

Q1 2018

 

     

 

Change

 

    

 

Change
at CER

 

  

 

 United States

   

 

 

 

2,198

 

 

   

 

 

 

-20.5

 

% 

  

 

 

 

-8.2

 

% 

 Emerging Markets(a)

      2,467        -3.1 %      +8.3 % 

of which Latin America

      650        -3.8 %      +13.6 % 

of which Asia(b)

      1,000        +1.2 %      +9.3 % 

of which Africa, Middle East

      491        -9.9 %      -0.7 % 

of which Eurasia(c)

      290        -3.0 %      +11.0 % 

 Europe(d)

      2,416        +0.2 %      +0.5 % 

 Rest of the World(e)

      817        -12.2 %      -3.4 % 

of which Japan

 

     

 

 445

 

  

 

     

 

 -15.9

 

 % 

 

    

 

 -7.6

 

 % 

 

 

 Total Sanofi sales

 

   

 

 

 

 

7,898

 

 

 

 

   

 

 

 

 

-8.7

 

 

% 

 

  

 

 

 

 

-0.4

 

 

% 

 

 

(a) World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico

 

7

(b) India, Bangladesh, Sri Lanka
(c) Russia, Ukraine, Georgia, Belarus, Armenia and Turkey
(d) Western Europe + Eastern Europe except Eurasia
(e) Japan, South Korea, Canada, Australia, New Zealand, Puerto Rico

First-quarter sales in the U.S. were €2,198 million, a decrease of 8.2% at CER reflecting the decline of Diabetes sales (down 26.6% at CER) and generic competition for sevelamer which were partially offset by the performance of Dupixent® and the consolidation of Eloctate® and Alprolix® sales.

First-quarter sales in Emerging Markets increased 8.3% at CER to €2,467 million, driven by Established Rx Products (up 9.7% at CER), Diabetes (up 17.7% at CER), CHC (up 14.4% at CER) and Rare Disease (up 20.8% at CER) franchises. In Asia, first-quarter sales were up 9.3% at CER to €1 billion, reflecting strong performance in China (up 13.6% at CER to €641 million) despite Pentaxim® local supply constraint. In Latin America, first-quarter sales increased 13.6% at CER to €650 million driven by Brazil (up 12.2% at CER to €301 million), Argentina and Mexico. CHC and Vaccines performances were particularly strong in Latin America in the first quarter with sales up 31.3% at CER and 22.5% at CER, respectively. In Africa and the Middle East, first-quarter sales were €491 million down 0.7% at CER and up 4.0% at CER excluding Maphar in Morocco (as part of its strategic objective to simplify the Company, Sanofi sold a controlling stake in Maphar at the end of Q2 2017 and therefore is no longer consolidating sales). First-quarter sales in the Eurasia region increased 11.0% at CER to €290 million, supported by strong growth in Turkey. First-quarter sales in Russia were €139 million up 4.7% at CER.

First-quarter sales in Europe were €2,416 million, up 0.5% at CER mainly driven by Vaccines (up 38.0% at CER) and Rare Disease (up 7.4% at CER) which offset lower sales in Established Rx Products (down 4.3% at CER) and CHC (down 5.0% at CER) sales.

Sales in Japan decreased 7.6% at CER to €445 million in the first quarter, impacted by generic Plavix® competition, together with lower sales of Aprovel® and Allegra®.

R&D update

Regulatory update

Regulatory updates since February 7, 2018 include the following:

 

  •   In March, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for cemiplimab (collaboration with Regeneron) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.

 

  •   In March, the EMA accepted for review an application for Dupixent® as an add-on maintenance treatment in certain adults and adolescents with inadequately controlled moderate-to-severe asthma. The U.S. Food and Drug Administration (FDA) also accepted for review the supplemental Biologics License Application of Dupixent® as an add-on maintenance treatment in certain adults and adolescents with moderate-to-severe asthma. Per the Prescription Drug User Fee Act, the target action date is October 20, 2018.

 

  •   In March, the EMA accepted for review Sanofi’s regulatory submission for sotagliflozin (developed in partnership with Lexicon) for adults with type 1 diabetes. Sotagliflozin was also submitted in the U.S. for type 1 diabetes.

At the end of April 2018, the R&D pipeline contained 74 projects including 37 new molecular entities in clinical development. 28 projects are in Phase 3 or have been submitted to the regulatory authorities for approval.

Portfolio update

Phase 3:

 

  •   The fitusiran phase 3 ATLAS program was reinitiated and the first patient was dosed in the ATLAS-INH study which will assess the benefit of fitusiran in adults and adolescents with hemophilia A or B with inhibitors.

 

  •   In March, ODYSSEY OUTCOMES results were presented during a late-breaker session at the American College of Cardiology. This trial met its primary endpoint, showing Praluent® (alirocumab, collaboration with Regeneron) significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event. Praluent® was also associated with a lower risk of death overall, known as “all-cause mortality”(14), and there were also numerically fewer CHD deaths(15). In a pre-specified

 

(14)  HR=0.85; CI: 0.73-0.98, nominal p=0.026
(15)  HR=0.92; CI: 0.76-1.11, p=0.38

 

8

 

analysis, the patients with baseline LDL-C levels at or above 100 mg/dL experienced a more pronounced effect from Praluent®, reducing their risk of MACE by 24%(16). In a post-hoc analysis of this group, Praluent® was associated with a lower risk of death from any cause by 29%(17).

 

  •   BIVV009 entered into Sanofi’s portfolio through the acquisition of Bioverativ. BIVV009 is being evaluated in Cold Agglutinin Disease, a rare blood disorder and the first patient was dosed in phase 3.

Phase 2:

 

  •   The phase 2 proof of concept study evaluating the dual-agonist (SAR425899) in overweight and obese type 2 diabetic patients confirmed SAR425899 is a potent hypoglycemic agent and can induce significant weight loss. However, the gastrointestinal tolerability observed with the dose escalation regimen used in the study is not considered to be acceptable for clinical use. An additional study was initiated in the first quarter to explore alternative titration regimens to facilitate improved tolerability and adherence and is expected to read-out in 2018.

 

  •   SAR440340 (collaboration with Regeneron), a monoclonal antibody anti IL33, moved into phase 2 for the treatment of asthma.

Alliances/Collaboration

 

  •   In March, Evotec and Sanofi entered into exclusive negotiations for Evotec to accelerate infectious disease research and development through a new open innovation platform near Lyon in France.

2018 first-quarter financial results(18)

Business Net Income(19)

In the first quarter of 2018, Sanofi generated net sales of €7,898 million, a decrease of 8.7% (down 0.4% at CER).

First-quarter other revenues decreased 8.4% (up 4.4% at CER) to €228 million, reflecting VaxServe sales contribution of non-Sanofi products of €169 million (up 12.7% at CER).

First-quarter Gross Profit decreased 9.6% to €5,611 million (down 0.8% at CER). The gross margin ratio was 71.0% (71.5% at CER) versus 71.7% in the first quarter of 2017. The positive impact of business mix toward Specialty Care was more than offset by the negative U.S. Diabetes net price evolution, sevelamer generic competition, Pentaxim® supply constraint in China, and currency variations. In the first quarter of 2018, the gross margin ratio of segments were 74.3% for Pharmaceuticals (down 0.7 percentage points), 67.8% for CHC (down 0.2 percentage points) and 57.1% for Vaccines (down 1.4 percentage points).

Research and Development (R&D) expenses decreased 2.2% to €1,280 million in the first quarter of 2018. At CER, R&D expenses increased 4.5% mainly reflecting the spend on immuno-oncology programs and medical investment behind the immunology franchise, partially offset by the end of the Regeneron antibody discovery program.

First-quarter selling general and administrative expenses (SG&A) decreased 6.9% to €2,310 million. At CER, SG&A expenses were up 1.0% reflecting investments in immunology, additional expenses in China and consolidation of Bioverativ’s operating expenses from March 9, which were partially offset by lower Diabetes expenses in the U.S. General expenses decreased in the first quarter, driven by cost containment measures. In the first quarter, the ratio of SG&A to sales increased 0.5 percentage points to 29.2% on a reported basis compared to the first quarter of 2017.

First-quarter other current operating income net of expenses was -€31 million versus €34 million in the first quarter of 2017 and included the share of profit to Regeneron of the monoclonal antibodies Alliance. In the first quarter of 2018, this line also included the Bioverativ acquisition-related fees.

The share of profits from associates was €74 million in the first quarter versus €24 million for the same period of 2017 partly driven by the increased contribution of the share of profits in Regeneron.

 

(16)  HR=0.76, CI: 0.65-0.87
(17)  HR=0.71, CI: 0.56-0.90
(18)  See Appendix 3 for 2018 first-quarter consolidated income statement; see Appendix 6 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income.
(19)  See Appendix 3 for 2018 first-quarter consolidated income statement; see Appendix 6 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income.

 

9

In the first quarter, non-controlling interests were -€30 million versus -€35 million in the first quarter of 2017.

First-quarter business operating income decreased 16.5% to €2,034 million(20). At CER, business operating income decreased 6.5%. The ratio of business operating income to net sales decreased 2.4 percentage points to 25.8% versus the first quarter of 2017. Over the period, the business operating income ratio of segments were 37.5% for Pharmaceuticals (down 1.5 percentage points), 34.2% for CHC (down 1.2 percentage points) and 18.0% for Vaccines (down 2.8 percentage points).

Net financial income (expense) was €2 million in the first quarter versus -€63 million in the same period of 2017. In the first quarter of 2018, net financial income (expense) included a gain of €76 million related to the shareholding in Impact Biomedicines which was acquired by Celgene.

The first-quarter effective tax rate was 22.0% compared to 24.5% in the first quarter of 2017 mainly reflecting the net positive impact of the U.S. tax reform and lower tax rates in different countries.

Reconciliation of IFRS net income reported to business net income (see Appendix 4)

In the first quarter of 2018, the IFRS net income was €1,016 million. The main items excluded from the business net income were:

 

  •   An amortization charge of €458 million related to fair value remeasurement on intangible assets of acquired companies (primarily Aventis: €73 million, Genzyme: €194 million, BI CHC business: €60 million and Bioverativ: €37 million) and to acquired intangible assets (licenses/products: €33 million). These items have no cash impact on the Company.

 

  •   A charge of €56 million mainly reflecting an increase of Bayer contingent considerations linked to Lemtrada® (a charge of €14 million) and fair value adjustment of contingent consideration linked to Sanofi Pasteur MSD termination (a charge of €33 million).

 

  •   Restructuring costs and similar items of €191 million mainly related to streamlining initiatives in the U.S. and Japan.

 

  •   A €185 million tax effect arising from the items listed above, mainly comprising €122 million of deferred taxes generated by amortization and impairments of intangible assets, and €52 million associated with restructuring costs and similar items (see Appendix 4).

 

  •   A €66 million tax effect arising mainly from the U.S. tax reform.

 

  •   An income of €44 million net of tax related to restructuring costs relating to investments accounted for using the equity method, and expenses arising from the impact of acquisitions on investments accounted for using the equity method.

Capital Allocation

In the first quarter of 2018, net cash generated by operating activities was €915 million after capital expenditures of €332 million and an increase in working capital of €445 million. This net cash flow funded restructuring costs and similar items (€170 million) and share repurchases (€603 million). Over the period, acquisitions and partnerships net of disposals were €8,888 million (including €8,979 million related to Bioverativ). As a consequence, debt, net of cash and cash equivalents increased from €5,229 million at December 31, 2017, to €14,142 million at March 31, 2018 (see the table below).

 

 

 (€ million)

 

   

 

At March 31,
2018

 

     

 

At December 31,
2017

 

  

 

 Long-term debt

 

   

 

 

 

 

21,460

 

 

 

 

   

 

 

 

 

14,326

 

 

 

 

 

 Short-term debt and current portion of long-term debt

 

   

 

 

 

 

5,542

 

 

 

 

   

 

 

 

 

1,275

 

 

 

 

 

 Interest rate and currency derivatives used to hedge debt

 

   

 

 

 

 

(61

 

 

) 

 

   

 

 

 

 

(57

 

 

) 

 

 

 Cash and cash equivalents

 

   

 

 

 

 

(12,799

 

 

) 

 

   

 

 

 

 

(10,315

 

 

) 

 

 

 Debt, net of cash and cash equivalents

 

   

 

 

 

 

14,142

 

 

 

 

   

 

€

 

 

5,229

 

 

 

 

 

(20)  See Appendix 2 for the reconciliation of business operating income to income before tax and investments accounted for using the equity method.

 

10

Forward-Looking Statements

This document 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 forward-looking 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, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions, and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives 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, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

11

Appendices

List of appendices

 

Appendix 1:    2018 first-quarter net sales by GBU, franchise, geographic region and product
Appendix 2:    2018 first-quarter components of business operating income and reconciliation of business operating income to income before tax and investments accounted for using the equity method
Appendix 3:    2018 first-quarter consolidated income statement
Appendix 4:    Reconciliation of IFRS net income reported to business net income
Appendix 5:    Currency sensitivity
Appendix 6:    Definitions of non-GAAP financial indicators

 

12

Appendix 1: 2018 first-quarter net sales by GBU, franchise, geographic region and product

 

 Q1 2018
 (€ million)

 

   

Total
GBUs

 

     

% CER

 

    

%
reported

 

             Europe     

% CER

 

            

United
States

 

     

% CER

 

            

Rest of

the World

 

     

%
CER

 

           

Emerging
Markets

 

     

% CER

 

           

Total
Franchises

 

     

% CER

 

    

%

reported

 

  

Aubagio

      359        10.2 %      -1.1 %         95        4.4 %         254        13.1 %         10        -7.7 %         12        75.0 %         371        11.6 %      0.0 % 

Lemtrada

      100        -10.0 %      -16.7 %         47        4.4 %         47        -17.9 %         6        -25.0 %         5        20.0 %         105        -8.8 %      -16.0 % 
 Total MS      459        5.2 %      -5.0 %         142        4.4 %         301        6.7 %         16        -14.3 %         17        53.8 %         476        6.5 %      -4.0 % 

Cerezyme

      116        -0.8 %      -7.2 %         66        -2.9 %         41        4.3 %         9        -9.1 %         59        37.3 %         175        10.2 %      -0.6 % 

Cerdelga

      36        25.8 %      16.1 %         10        100.0 %         24        8.0 %         2        100.0 %         0        —            36        25.8 %      16.1 % 

Myozyme

      170        11.0 %      4.3 %         93        14.6 %         64        10.4 %         13        -7.1 %         26        11.1 %         196        11.1 %      3.2 % 

Fabrazyme

      152        6.3 %      -3.8 %         42        5.0 %         86        6.5 %         24        8.0 %         18        10.5 %         170        6.8 %      -4.0 % 

Aldurazyme

      34        2.9 %      -2.9 %         19        0.0 %         10        9.1 %         5        0.0 %         17        11.1 %         51        5.7 %      -3.8 % 

 Total Rare Disease

      566        3.9 %      -3.9 %         246        7.4 %         246        3.3 %         74        -3.6 %         129        20.8 %         695        6.9 %      -2.7 % 

Taxotere

      8        -20.0 %      -20.0 %         1        0.0 %         0        0.0 %         7        -25.0 %         35        2.7 %         43        -2.1 %      -8.5 % 

Jevtana

      94        13.5 %      5.6 %         40        8.1 %         41        17.5 %         13        16.7 %         5        -25.0 %         99        10.3 %      2.1 % 

Eloxatin

      7        0.0 %      -12.5 %         1        -50.0 %         0        —            6        16.7 %         37        8.1 %         44        6.7 %      -2.2 % 

Thymoglobulin

      51        1.8 %      -10.5 %         9        -10.0 %         37        4.9 %         5        0.0 %         19        33.3 %         70        8.3 %      -2.8 % 

Mozobil

      36        2.6 %      -5.3 %         12        9.1 %         21        -4.0 %         3        50.0 %         2        50.0 %         38        5.0 %      -5.0 % 

 Total Oncology

      254        -10.1 %      -17.3 %         89        1.1 %         122        -22.7 %         43        23.7 %         104        7.6 %         358        -5.6 %      -13.1 % 

Dupixent

      107        —         —            10        —            95        —            2        —            0        —            107        —         —    

Kevzara

      10        —         —            2        —            8        —            0        —            0        —            10        —         —    

 Total Immunology

      117        —         —            12        —            103        —            2        —            0        —            117        —         —    

Alprolix

      21        —         —            0        —            16        —            5        —            0        —            21        —         —    

Eloctate

      43        —         —            0        —            35        —            8        —            0        —            43        —         —    

 Total Rare Blood Disorder

      64        —         —            0        —            51        —            13        —            0        —            64        —         —    

 Sanofi Genzyme (Specialty Care)

      1,460        16.2 %      5.9 %         489        7.9 %         823        21.4 %         148        14.7 %         250        16.9 %         1,710        16.3 %      5.4 % 

Lantus

      663        -24.5 %      -31.9 %         181        -9.0 %         413        -31.0 %         69        -8.2 %         248        8.6 %         911        -17.7 %      -25.9 % 

Toujeo

      169        4.0 %      -4.0 %         67        45.7 %         85        -14.8 %         17        20.0 %         28        146.2 %         197        13.8 %      4.2 % 

Apidra

      64        -8.1 %      -13.5 %         35        0.0 %         21        -17.2 %         8        -10.0 %         27        29.2 %         91        1.0 %      -7.1 % 

Amaryl

      11        -29.4 %      -35.3 %         4        -20.0 %         0        -100.0 %         7        -27.3 %         72        9.7 %         83        2.2 %      -6.7 % 

Soliqua / Suliqua

      9        175.0 %      125.0 %         0        —            9        150.0 %         0        —            0        —            9        175.0 %      125.0 % 

 Total Diabetes

      964        -18.0 %      -25.3 %         323        -0.9 %         534        -26.6 %         107        -4.8 %         392        17.7 %         1,356        -10.0 %      -18.5 % 

Multaq

      77        -9.4 %      -19.8 %         11        0.0 %         66        -8.4 %         0        -100.0 %         2        0.0 %         79        -9.2 %      -19.4 % 

Praluent

      47        54.5 %      42.4 %         19        137.5 %         26        25.0 %         2        100.0 %         2        100.0 %         49        55.9 %      44.1 % 

 Total Cardiovascular

      124        7.0 %      -3.9 %         30        57.9 %         92        -0.9 %         2        -33.3 %         4        33.3 %         128        7.6 %      -3.0 % 

 Diabetes & Cardiovascular

      1,088        -15.7 %      -23.4 %         353        2.3 %         626        -23.7 %         109        -5.4 %               396        17.9 %         1,484        -8.7 %      -17.3 % 

Plavix

      387        8.9 %      1.8 %         38        -2.6 %         0        —            52        -29.1 %         297        22.1 %         387        8.9 %      1.8 % 

Lovenox

      391        -0.7 %      -5.6 %         244        -5.1 %         12        -6.7 %         20        0.0 %         115        9.2 %         391        -0.7 %      -5.6 % 

Renagel / Renvela

      101        -54.1 %      -58.9 %         16        -11.1 %         61        -66.2 %         9        11.1 %         15        41.7 %         101        -54.1 %      -58.9 % 

Aprovel/Avapro

      172        -3.1 %      -10.4 %         28        -9.7 %         2        0.0 %         20        -52.3 %         122        17.5 %         172        -3.1 %      -10.4 % 

Allegra

      52        -16.2 %      -23.5 %         2        0.0 %         0        —            50        -16.7 %         0        —            52        -16.2 %      -23.5 % 

Myslee / Ambien / Stilnox

      61        -8.2 %      -16.4 %         11        10.0 %         10        -20.0 %         22        -17.2 %         18        5.3 %         61        -8.2 %      -16.4 % 

Synvisc / Synvisc One

      68        -15.6 %      -24.4 %         6        -25.0 %         45        -22.4 %         4        -25.0 %         13        36.4 %         68        -15.6 %      -24.4 % 

Depakine

      114        6.2 %      0.9 %         42        0.0 %         0        —            3        -25.0 %         69        11.9 %         114        6.2 %      0.9 % 

Tritace

      57        -3.2 %      -8.1 %         36        -7.7 %         0        —            1        0.0 %         20        4.5 %         57        -3.2 %      -8.1 % 

Other Rx Drugs

      917        -3.4 %      -9.9 %         448        -3.4 %         50        1.7 %         95        -7.8 %         324        -2.9 %         917        -3.4 %      -9.9 % 

 Total Established
Rx Products

      2,320        -6.4 %      -12.7 %         871        -4.3 %         180        -42.5 %         276        -19.3 %         993        9.7 %         2,320        -6.4 %      -12.7 % 

 Generics

      435        0.9 %      -6.7 %         184        -6.1 %         23        -27.0 %         49        60.6 %         179        3.0 %         435        0.9 %      -6.7 % 

 Total Emerging Markets Specialty Care

      250        16.9 %      2.9 %                                                                     250        16.9 %                             

 Total Emerging Markets Diabetes & Cardiovascular

      396        17.9 %      5.6 %                                                                     396        17.9 %                             

 General Medicines & Emerging Markets

      3,401        -1.5 %      -9.1 %         1,055        -4.6 %         203        -41.0 %         325        -12.8 %         1,818        11.6 %             
                                                       

 Total Pharmaceuticals

      5,949        -0.9 %      -9.0 %         1,897        -0.4 %         1,652        -10.4 %         582        -5.6 %         1,818        11.6 %         5,949        -0.9 %      -9.0 % 
                                                       

Allergy, Cough and Cold

      341        -8.1 %      -16.2 %         100        -4.7 %         105        -20.8 %         54        3.6 %         82        2.2 %         341        -8.1 %      -16.2 % 

Pain

      324        8.9 %      -0.3 %         132        -5.0 %         37        -2.3 %         27        7.4 %         128        30.4 %         324        8.9 %      -0.3 % 

Digestive

      248        15.0 %      6.0 %         84        -1.2 %         48        25.0 %         13        25.0 %         103        23.7 %         248        15.0 %      6.0 % 

Nutritional

      164        3.4 %      -5.7 %         33        3.1 %         9        0.0 %         58        0.0 %         64        7.5 %         164        3.4 %      -5.7 % 

 Consumer Healthcare

      1,238        2.0 %      -6.9 %         382        -5.0 %         287        -4.9 %         160        2.9 %         409        14.4 %         1,238        2.0 %      -6.9 % 
                                                       

Polio / Pertussis / Hib

      380        -4.6 %      -12.0 %         71        26.3 %         111        0.8 %         41        0.0 %         157        -17.6 %         380        -4.6 %      -12.0 % 

Adult Booster Vaccines

      92        26.6 %      16.5 %         37        117.6 %         41        4.4 %         7        12.5 %         7        -22.2 %         92        26.6 %      16.5 % 

Meningitis / Pneumonia

      89        7.4 %      -6.3 %         0        -100.0 %         67        8.5 %         4        150.0 %         18        -4.8 %         89        7.4 %      -6.3 % 

Influenza Vaccines

      29        -15.8 %      -23.7 %         1        —            4        66.7 %         5        -50.0 %         19        -16.0 %         29        -15.8 %      -23.7 % 

Travel And Other Endemics Vaccines

      102        2.8 %      -3.8 %         27        22.7 %         22        -13.8 %         15        21.4 %         38        -2.4 %         102        2.8 %      -3.8 % 

 Vaccines

      711        -0.9 %      -9.3 %         137        38.0 %         259        4.2 %         75        1.2 %         240        -18.4 %         711        -0.9 %      -9.3 % 

 Total Company

      7,898        -0.4 %      -8.7 %               2,416        0.5 %               2,198        -8.2 %               817        -3.4 %               2,467        8.3 %         7,898        -0.4 %      -8.7 % 

 

13

Appendix 2:

Components of Business Operating Income by Segment

 

 First quarter
 2018		    Pharmaceuticals     Consumer Healthcare     Vaccines     Others(2)     Total Group  
 € million    Q1
2018		     Q1
2017(1)		     Change     Q1
2018		     Q1
2017(1)		     Change     Q1
2018		     Q1
2017(1)		     Change     Q1
2018		     Q1
2017(1)		     Change     Q1
2018		     Q1
2017(1)		     Change  

 Net sales

      5,949       6,539       (9.0 %)      1,238       1,330       (6.9 %)      711       784       (9.3 %)      —         —         —         7,898       8,653       (8.7 %) 

 Other revenues

      58       76       (23.7 %)      —         —         —         170       173       (1.7 %)      —         —         —         228       249       (8.4 %) 

 Cost of sales

      (1,587 )      (1,710 )      (7.2 %)      (399 )      (425 )      (6.1 %)      (475 )      (498 )      (4.6 %)      (54 )      (64 )      (15.6 %)      (2,515 )      (2,697 )      (6.7 %) 

 As % of net sales

      (26.7 %)      (26.2 %)        (32.2 %)      (32.0 %)        (66.8 %)      (63.5 %)              (31.8 %)      (31.2 %)   

 Gross profit

      4,420       4,905       (9.9 %)      839       905       (7.3 %)      406       459       (11.5 %)      (54 )      (64 )      (15.6 %)      5,611       6,205       (9.6 %) 

 As % of net sales

      74.3 %      75.0 %        67.8 %      68.0 %        57.1 %      58.5 %              71.0 %      71.7 %   

 Research & Development expenses

      (978 )      (1,000 )      (2.2 %)      (28 )      (22 )      27.3 %      (126 )      (123 )      2.4 %      (148 )      (164 )      (9.8 %)      (1,280 )      (1,309 )      (2.2 %) 

 As % of net sales

      (16.4 %)      (15.3 %)        (2.3 %)      (1.7 %)        (17.7 %)      (15.7 %)              (16.2 %)      (15.1 %)   

 Selling and general expenses

      (1,254 )      (1,385 )      (9.5 %)      (389 )      (436 )      (10.8 %)      (153 )      (170 )      (10.0 %)      (514 )      (491 )      4.7 %      (2,310 )      (2,482 )      (6.9 %) 

 As % of net sales

      (21.1 %)      (21.2 %)        (31.4 %)      (32.8 %)        (21.5 %)      (21.7 %)              (29.2 %)      (28.7 %)   

 Other current operating income/ expenses

      (7 )      33         5       32         2       (3 )        (31 )      (28 )        (31 )      34    

 Share of profit/loss of associates* and joint-ventures

      75       24         —         —           (1 )      —           —         —           74       24    

 Net income attributable to non-controlling interests

      (26 )      (27 )        (4 )      (8 )        —         —           —         —           (30 )      (35 )   

 Business operating income

      2,230       2,550       (12.5 %)      423       471       (10.2 %)      128       163       (21.5 %)      (747 )      (747 )      —         2,034       2,437       (16.5 %) 

 As % of net sales

      37.5 %      39.0 %        34.2 %      35.4 %        18.0 %      20.8 %              25.8 %      28.2 %   

 

* Net of tax.
(1) 2017 restated using the new revenue recognition standard IFRS15, effective January 1, 2018.
(2) Others include the cost of global support functions (Medical Affairs, External Affairs, Finance, Human Resources, Information Solution & Technologies, Sanofi Business Services, etc.).

 

14

Reconciliation of business operating income to income before tax

and investments accounted for using the equity method

 

 € million    Q1 2018     Q1 2017(3)     % change  

 Business operating income

      2 034       2 437       (16.5 %) 

Share of profit/loss from investments accounted for using the equity method(1)

      (74 )      (24 )   

Net income attributable to non-controlling interests(2)

      30       35    

Amortization of intangible assets

      (458 )      (503 )   

Impairment of intangible assets

      (3 )      —      

Fair value remeasurement of contingent consideration liabilities

      (56 )      (36 )   

Expenses arising from the impact of acquisitions on inventories

      (30 )      (88 )   

Restructuring costs and similar items

      (191 )      (119 )   

Other expenses related to business combinations

      (2 )      —      

Other gains and losses, and litigation

      (49 )      —      

 Operating income

      1 201       1 702       (29.4 %) 

Financial expense

      (95 )      (111 )   

Financial income

      97       48    

 Income before tax and investments accounted for using the equity method

      1 203       1 639       (26.6 %) 

 

(1) Excluding restructuring costs relating to investments accounted for using the equity method and expenses arising from the impact of acquisitions on investments accounted for using the equity method.
(2) Excluding share of restructuring and other adjusting items attributable to non-controlling interests.
(3) 2017 restated using the new revenue recognition standard IFRS 15, effective January 1, 2018.

 

15

Appendix 3: Consolidated income statements

 

  € million    Q1 2018      Q1 2017(1)  

  Net sales

      7,898        8,653  

Other revenues

      228        249  

Cost of sales

      (2,545 )       (2,785 ) 

  Gross profit

      5,581        6,117  

Research and development expenses

      (1,280 )       (1,309 ) 

Selling and general expenses

      (2,312 )       (2,482 ) 

Other operating income

      25        60  

Other operating expenses

      (56 )       (26 ) 

Amortization of intangible assets

      (458 )       (503 ) 

Impairment of intangible assets

      (3 )       —    

Fair value remeasurement of contingent consideration

      (56 )       (36 ) 

Restructuring costs and similar items

      (191 )       (119 ) 

Other gains and losses and litigation

      (49 )       —    

  Operating income

      1,201        1,702  

Financial expenses

      (95 )       (111 ) 

Financial income

      97        48  

  Income before tax and investments accounted for using the equity method

      1,203        1,639  

Income tax expense

      (187 )       (336 ) 

Share of profit/loss from investments accounted for using the equity method

      30        —    

  Net income excluding the held for exchange Animal Health business

      1,046        1,303  

Net income from the held for exchange Animal Health business(2)

      (1 )       4,427  

  Net income

      1,045        5,730  

Net income attributable to non-controlling interests

      29        34  

  Net income attributable to equity holders of Sanofi

      1,016        5,696  

  Average number of shares outstanding (million)

      1,248.2        1,262.4  

  Earnings per share (in euros) excluding the held for exchange Animal Health business

      0.81        1.01  

  IFRS earnings per share (in euros)

      0.81        4.51  

 

(1) 2017 restated using the new revenue recognition standard IFRS15, effective January 1, 2018.
(2) In 2017, net gain resulting from the divestment of the Animal Health business presented separately in accordance with IFRS 5, Non current assets held-for-sale and discontinued operations.

 

16

Appendix 4: Reconciliation of Net income attributable to equity holders of Sanofi to Business net income

 

  € million    Q1 2018     Q1 2017(1)     Variation  

  Net income attributable to equity holders of Sanofi

      1,016       5,696       (82.2 %) 

  Amortization of intangible assets(2)

      458       503    

  Impairment of intangible assets

      3       —      

  Fair value remeasurement of contingent consideration

      56       36    

  Expenses arising from the impact of business combinations on inventories

      30       88    

  Other expenses related to business combinations

      2       —      

  Restructuring costs and similar items

      191       119    

  Other gains and losses, and litigation(3)

      49       —      

  Tax effect of items listed above:

      (185 )      (248 )   

Amortization & impairment of intangible assets

      (122 )      (182 )   

Fair value remeasurement of contingent consideration

      (6 )      (6 )   

Expenses arising from the impact of business combinations on inventories

      (6 )      (28 )   

Other expenses related to business combinations

      (1 )      —      

Restructuring costs and similar items

      (52 )      (43 )   

Other tax effects

      2       11    

  Other tax ítems(4)

      (66 )      —      

  Share of items listed above attributable to non-controlling interests

      (1 )      (1 )   

  Restructuring costs relating to investments accounted for using the equity method, and expenses arising from the impact of acquisitions on investments accounted for using the equity method

      44       24    

  Animal Health items(5)

      1       (4,427 )   

  Business net income

      1,598       1,790       (10.7 %) 

  IFRS earnings per share(6) (in euros)

      0.81       4.51    

 

(1) 2017 restated using the new revenue recognition standard IFRS15, effective January 1, 2018.
(2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €425 million in the first quarter of 2018 and €466 million in the first quarter of 2017.
(3) In 2018, separation costs for the European Generics business divestiture.
(4) In 2018, mainly due to US tax reform.
(5) In 2017, net gain resulting from the divestment of the Animal Health business presented separately in accordance with IFRS 5, Non current assets held-for-sale and discontinued operations.
(6) Based on an average number of shares outstanding of 1,248.2 million in the first quarter of 2018 and 1,262.4 million in the first quarter of 2017.

 

17

Appendix 5: Currency sensitivity

Currency exposure on Q1 2018 sales

 

  Currency    Q1 2018  

  US $

      28.9 % 

  Euro €

      26.4 % 

  Chinese Yuan

      7.8 % 

  Japanese Yen

      5.3 % 

  Brazilian Real

      3.7 % 

  British Pound

      2.1 % 

  Russian Ruble

      1.8 % 

  Australian $

      1.5 % 

  Canadian $

      1.5 % 

  Mexican Peso

      1.3 % 

  Others

      19.7 % 

Currency average rates

 

     Q1 2018      Q1 2017      Change  

  €/$

      1.23        1.06        +15.4 % 

  €/Yen

      133.16        121.12        +9.9 % 

  €/Yuan

      7.81        7.32        +6.8 % 

  €/Real

      3.99        3.35        +19.3 % 

  €/Ruble

      69.93        62.53        +11.8 % 

 

18

Appendix 6: Definitions of non-GAAP financial indicators

Company

“Company” corresponds to Sanofi and its subsidiaries

Company 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 net sales to Company sales at constant exchange rates for the first quarter 2018

 

  € million    Q1 2018  

  Net sales

      7,898  

  Effect of exchange rates

      (719 ) 

  Company sales at constant exchange rates

      8,617  

Business net income

Sanofi publishes a key non-GAAP indicator.

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 related to business combinations or to disposals,

 

  •   other impacts associated with acquisitions (including impacts of acquisitions on investments accounted for using the equity method),

 

  •   restructuring costs and similar items(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,

 

  •   net income attributable to non-controlling interests related to the items listed above,

 

(1) Reported in the line items Restructuring costs and similar items and Gains and losses on disposals, and litigation, which are defined in Note B.20. to our consolidated financial statements.

 

19