EX-99.1 2 d380426dex991.htm EX-99.1 EX-99.1

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Information on Q1 2017 Financial Results

 

     Q1 2017      Change     Change at CER  

IFRS net sales reported

   8,648m        +11.1     +8.6

IFRS net income reported

   5,701m        +424.5     —    

IFRS EPS reported

   4.52        +438.1     —    
  

 

 

    

 

 

   

 

 

 

Business net income(1)

   1,795m        +4.2     +1.0

First-quarter 2017 accounts reflect the acquisition of the former Boehringer Ingelheim Consumer Healthcare (CHC) business and the disposal of the Animal Health business (completed on January 1, 2017(2)). In accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations), Animal Health results in 2016 and gain on disposal in 2017 are reported separately. The first quarter 2017 income statement also reflects the consolidation of European operations related to Sanofi vaccine portfolio, following the termination of the Sanofi Pasteur MSD joint venture (SPMSD JV) with Merck at the end of December 2016.

 

(1) 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 7 for definitions). The consolidated income statement for Q1 2017 is provided in Appendix 2 and a reconciliation of IFRS net income reported to business net income is set forth in Appendix 3; (2) The closing of the disposal of Merial in Mexico is expected in 2017

 

1


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.

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)
 

Sanofi Genzyme (Specialty Care)(a)

     1,379        +15.5

Diabetes and Cardiovascular(a)

     1,419        -7.7

General Medicines & Emerging Markets(b)

     3,725        +2.2

Consumer Healthcare (CHC)

     1,341        +42.7

Total Pharmaceuticals

     7,864        +7.4

Sanofi Pasteur (Vaccines)

     784        +22.2  

Total Company sales

     8,648        +8.6

 

(a) Does not include Emerging Markets sales- see definition page 7; (b) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care;

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)
   

Developed

Markets

    

Emerging

Markets

 

Specialty Care

     1,620        +15.6     1,379        241  

Diabetes and Cardiovascular

     1,795        -4.0     1,419        376  

Established Rx Products

     2,640        +0.6     1,634        1,006  

Consumer Healthcare (CHC)

     1,341        +42.7     937        404  

Generics

     468        -2.0     268        200  

Vaccines

     784        +22.2     468        316  

Total net sales

     8,648        +8.6     6,105        2,543  

Pharmaceuticals

First-quarter Pharmaceuticals sales increased 7.4% to €7,864 million.

 

(7) See Appendix 7 for definitions of financial indicators.

 

2


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).

 

3


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.

 

4


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)
 

Allergy Cough & Cold

     414        +58.7

of which Allegra®

     145        -0.7

of which Mucosolvan®

     35        na  

Pain

     324        +45.1

of which Doliprane®

     83        +7.8

of which Buscopan®

     42        na  

Digestive

     229        +55.6

of which Dulcolax®

     47        na  

of which Enterogermina®

     47        +9.5

of which Essentiale®

     35        -17.9

of which Zantac®

     27        na  

Nutritionals

     164        +36.3

of which Pharmaton®

     17        na  

Other

     210        +11.0

of which Gold Bond®

     50        +2.1

Total Consumer Healthcare

     1,341        +42.7

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).

In Europe, CHC sales were up 68.2% to €406 million.

 

5


In the U.S., first quarter CHC sales increased 18.7% to €348 million.

In Emerging Markets, first-quarter CHC sales increased 20.9% to €404 million.

In the rest of the world, CHC sales were up 151.5% to €183 million.

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)

 

Polio/Pertussis/Hib vaccines

(incl. Pentacel®, Pentaxim® and Imovax®)

     432        +46.2

Influenza vaccines

(incl. Vaxigrip® and Fluzone®)

     38        +85.0

Adult Booster vaccines (incl. Adacel ®)

     79        -5.0

Meningitis/Pneumonia vaccines

(incl. Menactra®)

     95        -24.6

Travel and other endemic vaccines

     106        +25.3

Dengvaxia®

     17        -5.3

Other vaccines

     17        +23.1

Total Vaccines (consolidated sales)

     784        +22.2

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. 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..

In the first quarter, Polio/Pertussis/Hib vaccines sales increased 46.2% to €432 million.

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%.

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%.

Company sales by geographic region

 

Sanofi sales (€ million)    Q1 2017      Change
(CER)
 

United States

     2,764        +3.0

Emerging Markets(a)

     2,543        +11.3

of which Latin America

     676        +18.6

of which Asia (including South Asia(b))

     983        +13.4

of which Africa, Middle East

     546        +1.6

of which Eurasia(c)

     298        +14.3

Europe(d)

     2,411        +10.4

Rest of the World(e)

     930        +14.9

of which Japan

     529        +19.9

Total Sanofi sales

     8,648        +8.6

 

6


(a) World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico
(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 €2,764 million, an increase of 3.0%.

First-quarter sales in Emerging Markets were €2,543 million, up 11.3%. In Asia, first quarter sales were up 13.4% to €983 million reflecting strong performance in China, driven by Pharmaceuticals and also by the end of the vaccines market disruption. In Latin America, first quarter sales increased 18.6% to €676 million sustained by Brazil. First-quarter sales in the Eurasia region increased 14.3% to €298 million supported by strong growth in Turkey. Over the quarter, sales in Russia were €147 million up 0.9%. In Africa and the Middle East, sales were €546 million up 1.6%.

First-quarter sales in Europe were €2,411 million, up 10.4%.

Sales in Japan increased 19.9% to €529 million in the first quarter..

 

7


R&D update

 

Consult Appendix 5 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.

 

8


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).. 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.

First-quarter selling general and administrative expenses (SG&A) were up 12.0% to €2,478 million (up 9.5% at CER).

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.

Net financial expenses were €63 million in the first quarter versus €117 million 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).

 

(8) See Appendix 2 for 2017 first-quarter Consolidated income statement; see Appendix 7 for definitions of financial indicators, and Appendix 3 for reconciliation of IFRS net income reported to business net income.
* Adjusted for BI CHC business and termination of SPMSD

 

9


Reconciliation of IFRS net income reported to business net income (see Appendix 3)

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.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that 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 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, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

10


Appendices

List of appendices

 

Appendix 1:   2017 first-quarter net sales by GBU, franchise, geographic region and product
Appendix 2:   2017 first-quarter consolidated income statement
Appendix 3:   Reconciliation of IFRS net income reported to business net income
Appendix 4:   Currency sensitivity
Appendix 5:   R&D pipeline

Appendix 6:

 

Expected R&D milestones

Appendix 7:   Definitions of non-GAAP financial indicators

 

11


Appendix 1: 2017 first-quarter net sales by GBU, franchise, geographic region and product

 

Q1 2017
(€ million)
   Total
GBUs
     %
CER
    %
reported
    Europe      % CER     United
States
     % CER     Rest
of the
World
     %
CER
    Emerging
Markets
     %
CER
    Total
Franchises
     %
CER
    %
reported
 

Aubagio

     363        30.1     33.5     91        23.0     259        33.0     13        30.0     8        14.3     371        29.7     33.0

Lemtrada

     120        41.2     41.2     45        31.4     67        39.1     8        150.0     5        33.3     125        40.9     42.0

Total MS

     483        32.8     35.3     136        25.7     326        34.2     21        64.3     13        20.0     496        32.4     35.1

Cerezyme

     126        -2.4     0.0     68        -2.8     46        0.0     12        -9.1     50        -10.7     176        -4.9     -3.3

Cerdelga

     31        30.4     34.8     5        66.7     25        26.3     1        0.0     0        —         31        30.4     34.8

Myozyme

     163        11.0     11.6     82        5.1     67        18.2     14        16.7     27        25.0     190        12.7     14.5

Fabrazyme

     158        12.3     14.5     40        8.1     93        13.9     25        13.6     19        54.5     177        15.4     18.8

Aldurazyme

     35        0.0     0.0     19        0.0     11        0.0     5        0.0     17        30.8     52        8.3     8.3

Total Rare Disease

     589        6.9     9.5     231        2.6     274        12.2     84        2.7     123        11.1     712        7.6     10.2

Taxotere

     10        -37.5     -37.5     1        0.0     1        0.0     8        -42.9     37        23.3     47        2.2     2.2

Jevtana

     89        4.8     6.0     37        5.7     40        2.6     12        9.1     8        16.7     97        5.6     7.8

Eloxatine

     8        -38.5     -38.5     2        100.0     0        —         6        -50.0     37        27.6     45        7.1     7.1

Thymoglobulin

     57        7.8     11.8     10        11.1     41        8.1     6        0.0     15        7.1     72        7.7     10.8

Mozobil

     38        12.1     15.2     11        10.0     25        14.3     2        0.0     2        0.0     40        11.4     14.3

Zaltrap

     15        -6.3     -6.3     13        8.3     2        -50.0     0        —         1        0.0     16        -5.9     -5.9

Total Oncology

     307        9.9     12.0     88        8.6     181        23.1     38        -26.0     105        22.6     412        12.8     15.1

Sanofi Genzyme (Specialty Care)

     1,379        15.5     18.0     455        9.8     781        23.1     143        -1.5     241        16.3     1,620        15.6     18.2

Lantus

     973        -18.8     -16.6     199        -14.8     690        -20.9     84        -9.1     253        9.6     1,226        -14.1     -12.1

Toujeo

     176        66.0     70.9     46        142.1     115        42.3     15        133.3     16        —         192        78.6     86.4

Apidra

     74        12.3     13.8     35        12.9     29        12.0     10        11.1     24        20.0     98        14.1     15.3

Amaryl

     16        -5.9     -5.9     5        -37.5     1        -100.0     10        37.5     73        8.5     89        5.7     1.1

Insuman

     21        -4.8     0.0     20        -4.8     1        0.0     0        0.0     6        -36.4     27        -15.6     -15.6

Total Diabetes

     1,290        -10.3     -8.1     326        -3.0     839        -14.7     125        5.2     373        12.1     1,663        -6.0     -4.1

Multaq

     96        10.7     14.3     11        0.0     83        9.6     2        —         2        0.0     98        10.5     14.0

Praluent

     33        166.7     175.0     8        200.0     24        155.6     1        —         1        —         34        175.0     183.3

Total Cardiovascular

     129        30.2     34.4     19        42.9     107        25.6     3        —         3        50.0     132        30.6     34.7

Diabetes & Cardiovascular

     1,419        -7.7     -5.3     345        -1.1     946        -11.5     128        7.0     376        12.3     1,795        -4.0     -2.0

Plavix

     380        -1.8     -2.1     39        -7.1     0        -100.0     79        -27.9     262        10.8     380        -1.8     -2.1

Lovenox

     415        2.2     2.7     257        -1.5     15        -6.7     23        -4.5     120        14.3     415        2.2     2.7

Renagel / Renvela

     246        2.1     5.1     18        -13.6     207        3.1     9        0.0     12        20.0     246        2.1     5.1

Aprovel

     193        13.0     14.2     31        -6.1     3        -25.0     45        61.5     114        8.5     193        13.0     14.2

Allegra

     68        -13.3     -9.3     2        50.0     0        —         66        -15.1     0        —         68        -13.3     -9.3

Myslee / Ambien / Stilnox

     73        -1.4     4.3     10        -9.1     15        0.0     29        -10.0     19        21.4     73        -1.4     4.3

Synvisc / Synvisc One

     90        -1.1     2.3     8        0.0     67        -4.5     4        150.0     11        -9.1     90        -1.1     2.3

Depakine

     112        9.8     9.8     40        2.5     0        —         4        -25.0     68        17.2     112        9.8     9.8

Tritace

     62        3.2     0.0     39        -2.5     0        —         1        —         22        4.5     62        3.2     0.0

Lasix

     35        2.9     2.9     18        -5.3     0        —         2        -50.0     15        23.1     35        2.9     2.9

Targocid

     37        0.0     0.0     19        -5.0     0        —         1        -50.0     17        13.3     37        0.0     0.0

Other Rx Drugs

     929        -1.6     0.1     426        -1.4     58        -24.3     99        3.3     346        1.8     929        -1.6     0.1

Total Established Rx Products

     2,640        0.6     1.9     907        -2.1     365        -4.9     362        -6.3     1,006        8.2     2,640        0.6     1.9

Generics

     468        -2.0     2.0     198        -3.4     37        -28.6     33        26.9     200        2.8     468        -2.0     2.0

Total Emerging Markets Specialty Care

     241        16.3     19.3                    241        16.3       

Total Emerging Markets Diabetes & Cardiovascular

     376        12.3     12.9                    376        12.3       

General Medicines & Emerging Markets

     3,725        2.2     3.9     1,105        -2.4     402        -7.6     395        -4.1     1,823        9.5     3,108        0.2     1.9

Allergy, Cough & Cold

     414        58.7     63.0     107        197.2     154        12.9     62        176.2     91        36.9     414        58.7     63.0

Pain

     324        45.1     50.7     139        47.4     44        16.7     29        600.0     112        27.5     324        45.1     50.7

Digestive

     229        55.6     61.3     85        59.3     44        500.0     12        450.0     88        3.8     229        55.6     61.3

Nutritionals

     164        36.3     45.1     33        17.9     1        0.0     63        65.7     67        26.5     164        36.3     45.1

Consumer Healthcare

     1,341        42.7     48.2     406        68.2     348        18.7     183        151.5     404        20.9     1,341        42.7     48.2

Total Pharmaceuticals

     7,864        7.4     9.9     2,311        8.1     2,477        1.9     849        13.1     2,227        11.3     7,864        7.4     9.9

Polio / Pertussis / Hib

     432        46.2     50.0     57        147.8     127        105.0     44        64.0     204        11.1     432        46.2     50.0

Adult Booster Vaccines

     79        -5.0     -1.3     17        21.4     45        -15.7     8        14.3     9        0.0     79        -5.0     -1.3

Meningitis/Pneumonia

     95        -24.6     -22.1     1        —         71        -30.3     2        -33.3     21        0.0     95        -24.6     -22.1

Influenza Vaccines

     38        85.0     90.0     0        -100.0     3        0.0     10        100.0     25        118.2     38        85.0     90.0

Travel And other endemic Vaccines

     106        25.3     27.7     22        187.5     29        16.7     14        18.2     41        0.0     106        25.3     27.7

Dengue

     17        -5.3     -10.5     0        —         0        —         0        —         17        -5.3     17        -5.3     -10.5

Vaccines

     784        22.2     25.4     100        110.4     287        13.5     81        38.2     316        11.5     784        22.2     25.4

Total Company

     8,648        8.6     11.1     2,411        10.4     2,764        3.0     930        14.9     2,543        11.3     8,648        8.6     11.1

 

12


Appendix 2: 2017 first-quarter consolidated income statement

 

€ million    Q1 2017 (1)      Q1 2016 (1)  

Net sales

     8,648        7,783  

Other revenues

     249        145  

Cost of sales

     (2,785      (2,447

Gross profit

     6,112        5,481  

Research and development expenses

     (1,309      (1,235

Selling and general expenses

     (2,478      (2,212

Other operating income

     60        217  

Other operating expenses

     (26      (124

Amortization of intangible assets

     (503      (444

Impairment of intangible assets

     —          —    

Fair value remeasurement of contingent consideration

     (36      (29

Restructuring costs and similar items

     (119      (500

Other gains and losses and litigation

     —          —    

Operating income

     1,701        1,154  

Financial expenses

     (111      (129

Financial income

     48        12  

Income before tax and associates and joint ventures

     1,638        1,037  

Income tax expense

     (336      (117

Share of profit/loss of associates and joint ventures

     6        93  

Net income excluding the held for exchange Animal Health business

     1,308        1,013  

Net income from the held for exchange Animal Health business

     4,427        100  

Net income

     5,735        1,113  

Net income attributable to non-controlling interests

     34        26  

Net income attributable to equity holders of Sanofi

     5,701        1,087  

Average number of shares outstanding (million)

     1,262.4        1,288.4  

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

     1.01        0.77  

IFRS earnings per share (in euros)

     4.52        0.84  

 

(1) Animal Health results in 2016 and gain on disposal in 2017 reported separately in accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations).

 

13


Appendix 3: Reconciliation of IFRS net income reported to business net income

 

€ million    Q1 2017      Q1 2016      Change  

Net income attributable to equity holders of Sanofi

     5,701        1,087        424.5

Amortization of intangible assets(1)

     503        444     

Impairment of intangible assets

     —          —       

Fair value remeasurement of contingent consideration

     36        29     

Expenses arising from the impact of acquisitions on inventories

     88        —       

Restructuring costs and similar items

     119        500     

Other gains and losses, and litigation

     —          —       

Tax effect of items listed above:

     (248      (338   

Amortization of intangible assets

     (182      (156   

Impairment of intangible assets

     —          —       

Fair value remeasurement of contingent consideration

     (6      (11   

Expenses arising from the impact of acquisitions on inventories

     (28      —       

Restructuring costs and similar items

     (43      (171   

Other tax effects

     11        —       

Other tax items

     —          —       

Share of items listed above attributable to non-controlling interests

     (1      (1   

Restructuring costs of associates and joint-ventures, and expenses arising from the impact of acquisitions on associates and joint-ventures

     24        (70   

Animal Health items(2)/(3)

     (4,427      71     

Business net income

     1,795        1,722        4.2

IFRS earnings per share(4) (in euros)

     4.52        0.84     

 

(1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €466 million in the first quarter of 2017 and €410 million in the first quarter of 2016.
(2) In 2017, net gain resulting from the divestment of the Animal Health business (based on preliminary closing statements).
(3) In 2016, includes the following items: impact of the discontinuation of depreciation and impairment of Property, Plant & Equipment starting at IFRS 5 application (Non-current held for sale and discontinued operations), impact of the amortization and impairment of intangible assets until IFRS 5 application, costs incurred as a result of the divestment as well as tax effect of these items.
(4) Based on an average number of shares outstanding of 1,262.4 million in the first quarter of 2017 and 1,288.4 million in the first quarter of 2016.

 

14


Appendix 4: currency sensitivity

Currency exposure on Q1 2017 sales

 

Currency    Q1 2017  

US $

     32.9

Euro €

     24.5

Chinese Yuan

     6.2

Japanese Yen

     5.6

Brazilian Real

     3.5

British Pound

     1.9

Russian Ruble

     1.7

Australian $

     1.6

Canadian $

     1.5

Mexican Peso

     1.1

Others

     19.5

Currency average rates

 

     Q1 2016      Q1 2017      Change  

€/$

     1.10        1.06        -3.3

€/Yen

     127.02        121.12        -4.6

€/Yuan

     7.21        7.32        +1.5

€/Real

     4.31        3.35        -22.3

€/Ruble

     82.47        62.53        -24.2

 

15


Appendix 5: R&D Pipeline

N : New Molecular Entity

R : Registration Study

Registration

 

N

sarilumab
Anti-IL6R mAb
Rheumatoid arthritis, U.S, EU

   Dengvaxia®(1)
Mild-to-severe
dengue fever vaccine

N

Dupixent®
Anti-IL4Ra mAb
Atopic dermatitis, EU

   PR5i
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine, U.S.

N

SAR342434
insulin lispro
Type 1+2 diabetes

   VaxiGrip® QIV IM(2)
Quadrivalent inactivated
influenza vaccine (3 years+)

Phase 3

 

dupilumab
Anti-IL4Ra mAb
Asthma, Nasal polyposis
   Clostridium difficile
Toxoid vaccine

N

isatuximab
Anti-CD38 naked mAb
Relapsed Refractory Multiple myeloma

   VaxiGrip® QIV IM
Quadrivalent inactivated
influenza vaccine (6-35 months)

N

patisiran (ALN-TTR02)
siRNA inhibitor targeting TTR
Familial amyloidotic polyneuropathy

   Pediatric pentavalent vaccine
DTP-Polio-Hib
Japan

N

GZ402666
neo GAA
Pompe Disease

   Men Quad TT
2nd generation meningococcal
ACYW conjugate vaccine

N

sotagliflozin
Oral SGLT-1&2 inhibitor
Type 1 & Type 2 diabetes

  

 

(1) Approved in 16 countries to date
(2) Approved in 28 countries as of end March 2017

 

16


Phase 2

 

 

dupilumab
Anti-IL4Ra mAb
Eosinophilic oesophagitis

  

N - R

olipudase alfa
rhASM Deficiency
Acid Sphingomyelinase Deficiency(1)

  

 

Rabies VRVg
Purified vero rabies vaccine

N

SAR156597
IL4/IL13 Bi-specific mAb
Idiopathic pulmonary fibrosis / Systemic Scleroderma

  

N

GZ402671
Oral GCS inhibitor
Gaucher related Parkinson’s Disease, Gaucher Disease Type 3, Fabry Disease

  

 

Tuberculosis
Recombinant subunit vaccine

N

GZ389988
TRKA antagonist
Osteoarthritis

  

N

fitusiran (ALN-AT3)
siRNA targeting Anti-Thrombin
Hemophilia

  

 

Fluzone® QIV HD
Quadrivalent inactivated
influenza vaccine – High dose

 

sarilumab
Anti-IL6R mAb
Uveitis

  

N

efpeglenatide
Long-acting GLP-1 receptor agonist
Type 2 diabetes

  

 

Adacel+
Tdap booster

N

SAR422459
ABCA4 gene therapy
Stargardt disease

  

N

SAR425899

GLP-1R/GCGR dual agonist

Type 2 diabetes

  

 

Shan 6
DTP-HepB-Polio-Hib

Pediatric hexavalent vaccine

N - R

SAR439684
PD-1 inhibitor
Advanced CSCC (Skin cancer)

  

N

SAR100842
LPA1 receptor antagonist
Systemic sclerosis

  

 

HIV

Viral vector prime & rgp120 boost vaccine

 

isatuximab
Anti-CD38 naked mAb
Acute Lymphoblastic Leukemia

  

N

SAR439152

Myosin inhibitor

Hypertrophic cardiomyopathy

  

 

SP0232(2)
Monoclonal antibody

Respiratory syncytial virus

N

SAR566658

Maytansin-loaded anti-CA6 mAb

Solid tumors

  

N - R

Combination

ferroquine / OZ439

Antimalarial

  

 

(1) Also known as Niemann Pick type B
(2) Also known as MEDI8897

Phase 1

 

N

SAR440340
Anti-IL33 mAb
Asthma & COPD

  

N

SAR408701

Maytansin-loaded anti-CEACAM5 mAb

Solid tumors

  

N

SAR247799

S1P1 agonist

Cardiovascular Indication

N

SAR439794
TLR4 agonist
Peanut allergy

  

N

SAR428926
Maytansin-loaded anti-Lamp1 mAb
Cancer

  

N

SAR407899

rho kinase

Microvascular angina

N

GZ402668
GLD52 (anti-CD52 mAb)
Relapsing multiple sclerosis

  

N

SAR438335

GLP-1R/GIPR dual agonist

Type 2 diabetes

  

 

Herpes Simplex Virus Type 2
HSV-2 vaccine

N

UshStat®

Myosin 7A gene therapy

Usher syndrome 1B

  

N

SAR341402

Rapid acting insulin

Diabetes

  

 

Zika
Inactivated Zika vaccine

N

SAR228810

Anti-protofibrillar AB mAb

Alzheimer’s disease

  

N

SAR440181(1)
DCM1 Myosin activation
Dilated cardiomyopathy

  

 

Respiratory syncytial virus
Infants

 

(1) Also known as MYK491

 

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Appendix 6: Expected R&D milestones

 

Products    Expected milestones    Timing
dupilumab    Start of Phase 3 trial in Asthma in 6-11 year-olds    Q2 2017
Kevzara®(1)    U.S. regulatory decision in Rheumatoid Arthritis    Q2 2017
Kevzara®(1)    European Commission decision in Rheumatoid Arthritis    Q2 2017
Dupixent®(1)    Start of Phase 3 trial in Atopic Dermatitis in 6-11 year-olds    Q3 2017
Fitusiran    Start of Phase 3 trial in Hemophilia    Q3 2017
Fluzone QIV HD    Start of Phase 3 trial    Q3 2017
VaxiGrip® QIV IM (6-35 months)    EU regulatory submission    Q3 2017
dupilumab    Phase 3 results in Asthma in Adult patients    Q4 2017
dupilumab    U.S. regulatory submission in Asthma in Adult patients    Q4 2017
patisiran    Phase 3 results in Familial amyloidotic polyneuropathy    Q4 2017
efpeglenatide    Start of Phase 3 trial in type-2 Diabetes    Q4 2017
sotagliflozine    Start of Phase 3 trials in combination therapies in type-2 Diabetes    2017
isatuximab    Start of additional Phase 3 trials in Multiple Myeloma and additional indications    2017
SAR439684 (PD-1)    Phase 2/3 to start in NSCLC(2) and BCC(3)    2017
Praluent®    ODYSSEY OUTCOMES top-line results    Q1 2018

 

(1) Name received conditional approval
(2) Non-Small Cell Lung Cancer
(3) Basal Cell Carcinoma

 

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Appendix 7: 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 of 2017

 

€ million    Q1 2017  

Net sales

     8,648  

Effect of exchange rates

     (194

Company sales at constant exchange rates

     8,454  

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 associates and joint ventures),

 

    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,

 

    tax (3%) on dividends paid to Sanofi shareholders,

 

    Animal Health items out of business net income(2),

 

    Net income attributable to non-controlling interests related to the items listed above.

We believe (subject to the limitations described below) that disclosing our business net income enhances the comparability of our operating performance, for the following reasons:

 

    the elimination of charges related to the purchase accounting effect of our acquisitions (particularly amortization and impairment of finite-lived intangible assets, other than software and other rights of an industrial or operational nature) enhances the comparability of our ongoing operating performance relative to our peers in the pharmaceutical industry that carry these intangible assets (principally patents and trademarks) at low book values either because they are the result of in-house research and development that has already been expensed in prior periods or because they were acquired through business combinations that were accounted for as poolings-of-interest;

 

    the elimination of selected items such as the incremental cost of sales arising from the workdown of inventories remeasured at fair value, gains and losses on disposals of non-current assets, and costs and provisions associated with major litigation improves comparability from one period to the next; and

 

    the elimination of restructuring costs and similar items enhances comparability because those costs are directly and only incurred in connection with transformation and reorganization processes intended to optimize our operations.

We remind investors, however, that business net income should not be considered in isolation from, or as a substitute for, Net income attributable to equity holders of Sanofi reported in accordance with IFRS. In addition, we strongly encourage investors and potential investors not to rely on any single financial measure but to review our financial statements, including the notes thereto, and our other publicly filed reports, carefully and in their entirety.

We compensate for the material limitations described above by using business net income only to supplement our IFRS financial reporting and by ensuring that our disclosures provide sufficient information for a full understanding of all adjustments included in business net income.

Because our business net income is not a standardized measure, it may not be comparable with the non-GAAP financial measures of other companies using the same or a similar non-GAAP financial measure.

 

(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.
(2) In 2016, impact of discontinuation of depreciation and impairment of Property, Plant and Equipment starting at IFRS 5 application (non-current assets held for sales and discontinued operations), amortization and impairment of intangible assets until IFRS 5 application and costs incurred as a result of the divestment as well as tax effect of these items; and in 2017 gain on the disposal of the Animal Health business, net of tax.

 

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