Paris, February 7, 2018
Sanofi Delivers 2017 Business EPS(1) in band with Advice
Fourth-quarter and 2017 accounts reflect the accretion of the aloft Boehringer Ingelheim Consumer Healthcare (CHC) business and the auctioning of the Beastly Bloom business (completed on January 1, 2017). In accordance with IFRS 5 (Non-Current Assets Captivated for Auction and Discontinued Operations), Beastly Bloom after-effects in 2016 and accretion on auctioning in 2017 are appear separately. Fourth-quarter and 2017 assets statements additionally reflect the accord of European operations accompanying to Sanofi vaccine portfolio, afterward the abortion of the Sanofi Pasteur MSD collective adventure (SPMSD JV) with Merck at the end of 2016.
Q4 2017 sales reflect able Dupixent® barrage anniversary by advancing declines in U.S. diabetes and Renagel®
Sanofi Genzyme, Sanofi Pasteur and Emerging Markets sales advance added than anniversary Diabetes sales abatement in 2017
Sanofi meets its full-year 2017 business EPS guidance
Sanofi progresses on its cardinal priorities
2018 banking angle
(1) In acclimation to facilitate an compassionate of operational performance, Sanofi comments on the business net assets statement. Business net assets is a non-GAAP banking admeasurement (see Appendix 10 for definitions). The circumscribed assets anniversary for Q4 2017 and 2017 is provided in Appendix 3 and a adaptation of IFRS net assets appear to business net assets is set alternating in Appendix 4; (2) CS: connected structure: adapted for BI CHC business, abortion of SPMSD and others; (3) changes in net sales are bidding at connected barter ante (CER) unless contrarily adumbrated (see Appendix 10); (4) See analogue folio 8; (5) based on accepted compassionate of the US tax reform; (6) Accountable to the achievement of the acquisition; (7) 2017 business EPS was €5.54
During 2017, Sanofi has progressively chip the Consumer Healthcare operations of Boehringer Ingelheim, acquired on January 1, 2017. Afterward the achievement of the affiliation action and able December 31, 2017, the CHC business formed a audible operating segment. Additionally, Sanofi accomplished the alteration of its administration advertisement in accordance with its revised authoritative anatomy in 2017. As a result, the costs of the all-around functions (Medical Affairs, Alien Affairs, Finance, Human Resources, Legal Affairs, Advice Solutions & Technologies, Sanofi Business Services, etc.) will be included in “Other”, as reconciling items to Group numbers. However, allusive advice for the antecedent year will not be restated to reflect the changes declared aloft because the all-important advice is not accessible and would be too circuitous to develop. The Q1 2018 antithesis columnist absolution will be based on this new segmentation. Sanofi’s Anniversary address Form 20-F and Certificate de Référence will accommodate the advice for the year 2017 on both the old abject (with allusive beforehand periods) and the assay principles.
2018 acceptance of IFRS15 and IFRS9
Based on the accepted assessment, Sanofi does not apprehend a absolute acquirement acceptance change beneath the new IFRS15 acquirement accepted which becomes able in 2018. Sanofi will accommodate restated abstracts in the examination certificate accompanying to Q1 2018. In addition, the Group does not ahead a absolute digest of 2017 Business EPS from the acceptance of IFRS9, the new IFRS accepted for banking instruments, additionally able in 2018.
2017 fourth-quarter and full-year Sanofi sales
In the fourth division of 2017, Company sales were €8,691 million, bottomward 2.0% on a appear basis. Barter bulk movements had a abrogating aftereffect of 6.1 allotment credibility mainly apprenticed by the movement of the U.S. Dollar accompanied by the Japanese Yen, Turkish Lira and Chinese Yuan. Company sales benefited from the accretion of Boehringer Ingelheim’s CHC business and abounding accord of Sanofi’s European vaccines operations arch to an admission of 4.1% at CER. At CER and CS, Company sales were bottomward 1.6%.
2017 Company sales accomplished €35,055 million, up 3.6% on a appear basis. Barter bulk movements had a abrogating aftereffect of 2.0 allotment points. At CER and CS, Company sales were up 0.5%.
Global Business Units
The table beneath presents sales by All-around Business Unit (GBU) and reflects the alignment of Sanofi. This anatomy drives added specialization, simplifies advertisement and provides a bright focus on advance drivers. Please agenda that Emerging Markets sales for Specialty Affliction and Diabetes and Cardiovascular are included in the Accepted Medicines and Emerging Markets GBU.
(a) Does not accommodate Emerging Markets sales- see analogue folio 8; (b) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Affliction
The tables beneath present fourth-quarter and full-year 2017 sales by all-around franchise, including Emerging Markets sales, to facilitate comparisons. Appendix 1 provides a adaptation of sales by GBU and franchise.
(8) See Appendix 10 for definitions of banking indicators.*CS: connected structure: adapted for BI CHC business, abortion of SPMSD and others
*CS: connected structure
*CS: connected structure
Fourth-quarter Pharmaceutical sales were up 3.3% to €7,306 million. At CS, Pharmaceutical sales were bottomward 2.1% primarily due to Diabetes and Established Rx Products. Full-year 2017 sales for Pharmaceuticals added 4.2% to €29,954 actor (down 0.8% at CS).
Rare Ache franchise
In the fourth quarter, Attenuate Ache sales added 8.0% to €726 actor apprenticed by Europe (up 12.3% to €255 million) and Emerging Markets (up 11.8% to €129 million). In the U.S., Attenuate Ache sales grew 5.2% to €259 actor in the fourth quarter. In 2017, Attenuate Ache sales added 6.0% to €2,888 million.
Fourth-quarter Gaucher (Cerezyme® and Cerdelga®) sales were up 8.9% at €216 actor accurate by added launches of Cerdelga® and solid Cerezyme® performance. Over this period, Cerezyme® sales were up 7.1% to €183 actor and Cerdelga® sales added 20.7% to €33 actor of which €24 actor were generated in the U.S. (up 13.0%). Full-year 2017 Gaucher sales added 2.9% to €856 million.
Fourth-quarter Myozyme®/Lumizyme® sales grew 11.5% to €205 actor apprenticed by European sales (up 20.0% to €95 million). Full-year 2017 Myozyme®/Lumizyme® sales added 10.1% to €789 million.
Fourth-quarter Fabrazyme® sales were up 6.0% to €180 actor admitting the bazaar admission of a new adversary in Europe and some added markets. Full-year 2017 Fabrazyme® sales were up 9.2% to €722 million.
Multiple Sclerosis franchise
Fourth-quarter Assorted Sclerosis (MS) sales grew 10.5% to €501 million, apprenticed by Aubagio® achievement in the U.S. and Europe. Full-year 2017 MS sales added 20.8% to €2,041 million.
Fourth-quarter Aubagio® sales added 13.6% to €389 actor apprenticed by the U.S. (up 9.8% to €266 million) and Europe (up 21.5% to €96 million). Full-year 2017 Aubagio® sales added 23.2% to €1,567 million. In the U.S., all of the awaiting ANDA litigations associated with Aubagio® (teriflunomide), accept been acclimatized and dismissed.
In the fourth division Lemtrada® sales were up 0.9% to €112 actor apprenticed by Europe (up 10.3% to €42 million). In the U.S., sales were bottomward 10.4% to €56 million, absorption beneath all-embracing infusions due to the different concise dosing dieting with assiduous continuance of ameliorative aftereffect as able-bodied as a added aggressive environment. Full-year 2017 Lemtrada® sales added 13.6% to €474 million.
Dupixent® (collaboration with Regeneron), which was launched in the U.S. in March for the assay of moderate-to-severe developed atopic dermatitis (AD), generated sales of €118 actor in the fourth quarter. In Europe, Dupixent® was accustomed at the end of September 2017 for use in adults with moderate-to-severe AD who are candidates for systemic assay and was launched in Germany in December. Full-year 2017, Dupixent® sales were €219 million.
Kevzara® (collaboration with Regeneron) was launched for rheumatoid arthritis in the U.S. in June and in Germany, the UK and the Netherlands during the added bisected of 2017. Fourth-quarter and full-year 2017 Kevzara® sales were €8 actor and €11 million, respectively.
Fourth-quarter and full-year 2017 oncology sales added 3.5% to €361 actor and 6.4% to €1,519 million, respectively.
Jevtana® sales were up 14.1% to €99 actor in the fourth division accurate by the achievement in all regions. Full-year 2017 Jevtana® sales added 9.8% to €386 million. Thymoglobulin® sales were abiding at €72 actor and added 5.3% to €291 actor in the fourth division and full-year, respectively. Eloxatin® sales added 14.6% to €44 actor in the fourth division apprenticed by China. Fourth-quarter Taxotere® sales were abiding at €40 million. Full-year 2017 sales of Taxotere® and Eloxatin® were bottomward 0.6% (to €173 million) and up 8.2% (to €179 million), respectively.
In the fourth quarter, all-around Diabetes sales decreased 15.6% to €1,533 million, absorption lower Sanofi glargine (Lantus® and Toujeo®) sales in the U.S. Fourth-quarter U.S. Diabetes sales were bottomward 29.5% to €730 actor absorption exclusions from bartering formularies at CVS and UnitedHealthcare as able-bodied as a aerial abject of allegory in the fourth division of 2016. Full-year 2017 U.S. Diabetes sales decreased 22.8% to €3,128 million. Fourth-quarter sales in Emerging Markets added 8.2% to €363 million. Fourth-quarter sales in Europe added 1.3% to €323 actor absorption Toujeo® growth. Full-year 2017 all-around Diabetes sales decreased 11.1% to €6,395 million.
In the fourth quarter, Sanofi glargine (Lantus® and Toujeo®) sales decreased 18.6% to €1,292 million. U.S. Sanofi glargine sales were bottomward 30.9% to €694 million, absorption the appulse of the exclusion from the CVS bartering blueprint from January 1, 2017 and from the UnitedHealthcare bartering blueprint from April 1, 2017 as able-bodied as a aerial abject of allegory in the fourth division of 2016. In Europe, Sanofi glargine sales added 2.5% to €246 actor due to the Toujeo® able achievement admitting biosimilar glargine antagonism in several European markets. Full-year 2017 Sanofi glargine sales decreased 13.0% to €5,438 million.
In the fourth quarter, Lantus® sales were €1,076 million, bottomward 20.9%. In the U.S., Lantus® sales decreased 31.4% to €584 actor mainly absorption lower boilerplate net price, the aloft appulse of blueprint exclusions as able-bodied as a aerial abject of allegory in the fourth division of 2016. In Europe, fourth-quarter Lantus® sales were €183 actor (down 7.5%) due to biosimilar glargine antagonism and patients switching to Toujeo®. In Emerging Markets, fourth-quarter sales were up 4.9% to €234 million. Full-year 2017 Lantus® sales decreased 17.5% to €4,622 million.
Fourth-quarter Toujeo® sales were €216 million, bottomward 4.2%. In the U.S., fourth-quarter Toujeo® sales were €110 actor bottomward 28.4% against the fourth division of 2016 (which was a aerial abject of comparison). However, Toujeo® sales showed absolute trend compared to the third division of 2017. In Europe and Emerging Markets, fourth-quarter Toujeo sales were €63 actor (up 51.2%) and €25 actor (versus €15 actor in the fourth division of 2016). Full-year 2017 Toujeo® sales added 27.0% to €816 million.
Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) was launched in the U.S. in January 2017 and SuliquaTM was additionally launched in some European countries in 2017. Soliqua® 100/33 / SuliquaTM sales were €9 actor in the fourth division and €26 actor in 2017.
Amaryl® sales were €81 million, bottomward 2.2% in the fourth quarter, of which €66 actor were generated in Emerging Markets (down 1.4%). Full-year 2017 Amaryl® sales were bottomward 1.4% to €337 million.
Fourth-quarter Apidra® sales added 8.4% to €97 million. Lower sales in the U.S. (down 10.3% to €25 million) were anniversary by able advance in Emerging Markets (up 40.9% to €28 million). Full-year 2017 Apidra® sales added 4.9% to €377 million.
Fourth-quarter Praluent® sales (collaboration with Regeneron) were €53 million, of which €35 actor was in the U.S. and €15 actor in Europe. This reflected cogent payer appliance administration restrictions in the U.S. and bound bazaar admission in Europe. Full-year 2017 Praluent® sales were €171 actor against €105 actor in 2016. Praluent® was launched in France in February 2018.
Fourth-quarter and 2017 Multaq® sales were €77 actor (down 11.7%) and €339 actor (down 2.5%), respectively.
Established Rx Products
In the fourth quarter, Established Rx Articles sales decreased 5.5% to €2,298 million. This reflected a abatement in sales in Europe (down 4.7% to €869 million), calm with all-encompassing antagonism to Renvela®/Renagel® in the U.S. and the appulse of all-encompassing antagonism to Plavix® in Japan, which added than anniversary Emerging Markets achievement (up 3.2% to €901 million). Full-year 2017 Established Rx Articles sales decreased 3.4% to €9,761 million.
Lovenox® sales decreased 2.7% to €388 actor in the fourth quarter, absorption added antagonism in Europe (down 9.0% to €231 million) which anniversary the advance in Emerging Markets (up 5.6% to €120 million). As of September, biosimilars accept been alien in the UK and Germany. Full-year 2017 Lovenox® sales decreased 2.1% to €1,575 million.
In the fourth quarter, Plavix® sales were up 2.5% to €348 actor abiding by Emerging Markets achievement (up 13.5% to €244 million) apprenticed by China which exceeded the appulse of all-encompassing antagonism in Japan (sales in Japan were bottomward 25.6% to €54 million). Full-year 2017 Plavix® sales decreased 1.2% to €1,471 million.
Fourth-quarter Renvela®/Renagel® sales decreased 28.5% to €155 actor due to all-encompassing antagonism in the U.S. (down 33.5% to €117 million). In October, Sanofi launched an accustomed all-encompassing of Renvela®/Renagel® on the U.S. market. Full-year 2017 Renvela®/Renagel® sales decreased 12.3% to €802 million.
Fourth-quarter Aprovel®/Avapro® sales added 2.5% to €158 million, absorption able achievement in China which anniversary lower sales to Sanofi’s accomplice in Japan. Full-year 2017 Aprovel®/Avapro® sales added 3.7% to €691 million.
CHC sales by cartography and class are provided in Appendix 1.
*CS: connected structure
In the fourth quarter, Consumer Healthcare (CHC) sales added 51.8% to €1,196 actor absorption the closing of the accretion of Boehringer Ingelheim CHC business on January 1, 2017. At CS, Sanofi CHC sales added 2.5% in the fourth quarter, apprenticed by Europe (up 5.7% to €387 million) and the U.S. (up 3.8% to €251 million) which anniversary the slight abatement in Emerging Markets (down 0.5% to €400 million). At CS, full-year 2017 CHC sales added 2.1% to €4,832 million.
In Europe, fourth-quarter CHC sales were up 69.0% to €387 million. At CS, sales added 5.7% mainly apprenticed by Doliprane® and Mucosolvan®, absorption an abnormal fasten in appeal at the end of the year, beforehand than in antecedent seasons. At CS, full-year 2017 CHC sales in Europe added 2.0% to €1,422 million.
In the U.S., fourth-quarter CHC sales added 31.1% to €251 million. At CS, CHC sales were up 3.8% absorption able achievement of abhorrence allotment as able-bodied as Gold Bond®. Fourth-quarter Xyzal® Abhorrence 24HR sales (approved in February) were €7 million. Fourth-quarter sales of the Digestive class were bottomward 16.4%, absorption lower Zantac® sales. At CS, full-year 2017 CHC sales added 1.3% to €1,133 million.
In Emerging Markets, fourth-quarter CHC sales added 32.8% to €400 million. At CS, CHC sales were bottomward 0.5% absorption lower sales in Russia and Mexico. Full-year 2017 Emerging Markets CHC sales added 3.0% to €1,616 actor at CS.
In the fourth quarter, Generics sales decreased 2.1% to €435 actor absorption lower sales in Europe (down 1.6% to €189 million) and in Emerging Markets (down 4.3% to €183 million). Full-year 2017 Generics sales decreased 3.3% to €1,778 million. Signing of absolute transaction agreements(9) on denial of European Generics is accepted in the third division of 2018.
*CS: connected structure
Fourth-quarter Vaccines sales were up 8.7% to €1,385 actor and reflected the abortion of the Sanofi Pasteur MSD collective adventure in Europe from December 31, 2016. At CS, sales were up 1.2%. In Europe, sales were up 347.7% to €196 actor and up 37.8% at CS apprenticed by Polio/Pertussis/Hib, Boosters and Flu franchises. This able achievement anniversary lower sales in Emerging Markets (down 6.1% to €471 million), as a aftereffect of a phasing aftereffect of Hexaxim® sales and the buy aback of bare doses of Dengvavia® afterward the appear characterization amend in November. In the U.S. (down 0.4% to €642 million) sales were impacted by decreased sales of Polio/Pertussis/Hib and Boosters vaccines. Full-year 2017 Vaccines sales grew 8.3% at CS to €5,101 million.
In the fourth quarter, Polio/Pertussis/Hib (PPH) vaccines sales decreased 3.9% to €493 million. At CS, PPH sales were bottomward 9.8%. In the U.S., PPH allotment sales decreased 27.1% absorption the aerial sales akin in the fourth division of 2016 which benefited from a banal bushing aftereffect on Pentacel®. The able achievement of Hexaxim® in Europe and Pentaxim® in China anniversary lower sales of the Pediatric AcXim aggregate ancestors in Emerging Markets mainly absorption the timing of accessible tenders. In China, Sanofi Pasteur expects accumulation of Pentaxim® to be accountable in the aboriginal bisected of 2018 due to a testing affair which, calm with the aerial abject for allegory on Menactra®, is accepted to aftereffect in lower all-embracing Vaccines GBU sales over this time period. At CS, full-year 2017 Polio/Pertussis/Hib vaccines sales added 15.3% to €1,827 million.
(9) Afterward achievement of the chat with amusing partners
Fourth-quarter Influenza vaccines sales added 28.4% to €502 actor and 20.5% at CS. This was apprenticed by a able achievement in the U.S. (up 25.4%) absorption €43 actor of communicable flu vaccines sales to BARDA (Biomedical Avant-garde Assay and Development Authority) and by the success of VaxigripTetraTM in Europe (flu vaccines sales were up 45.5% in Europe). Full-year 2017 Influenza vaccines sales were €1,589 million, up 8.2% at CS.Fourth-quarter Menactra® sales decreased 19.6% to €79 actor due to lower sales in the U.S., absorption the phasing aftereffect from CDC (Centers for Ache Control) orders. Full-year 2017 Menactra® sales were up 4.6% to €600 million.
Fourth-quarter Developed Booster vaccines sales were €137 million, up 13.2% and bottomward 0.7% at CS absorption lower Adacel® sales in the U.S admitting bigger accumulation of Repevax® in Europe. At CS, full-year 2017 Developed Booster vaccines sales were broadly abiding at €474 million.
Fourth-quarter Travel and added ancient vaccines sales were €160 actor up 55.1% (up 33.9% at CS) absorption bigger accumulation of Rabies and Hepatitis A vaccines. At CS, full-year 2017 Travel and added ancient vaccines sales were up 19.0% to €493 million.
On November 29, 2017, Sanofi appear that it will ask bloom authorities to amend advice provided to physicians and patients on its dengue vaccine Dengvaxia® in countries area it is approved. The appeal was based on a new assay of abiding analytic balloon data, which begin differences in vaccine achievement based on above-mentioned dengue infection.Fourth-quarter Dengvaxia® sales were -€19 actor absorption the buy aback of bare doses. Full-year 2017 Dengvaxia® sales were €3 million.
Company sales by geographic region
*CS : connected anatomy : Adapted for BI CHC business and abortion of SPMSD and others(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
Fourth-quarter sales in the U.S. were €2,851 million, a abatement of 6.2% or 7.7% at CS impacted by the abatement of Diabetes sales (down 29.5%) and all-encompassing antagonism to Renvela®/Renagel® which were partially anniversary by the achievement of Dupixent®. In the U.S., full-year 2017 sales decreased 3.5% at CS to €11,855 million.
Fourth-quarter sales in Emerging Markets were €2,569 million, up 6.3% or 2.1% at CS accountable by lower Vaccines sales and abiding CHC performance. In Asia, fourth-quarter sales were up 5.1% (up 3.0% at CS) to €874 actor apprenticed by achievement in China (up 14.2% at CS to €525 million), partially anniversary by the buy aback of bare doses of Dengvaxia® in the Philippines. In Latin America, fourth-quarter sales added 14.5% (up 7.4% at CS) to €756 actor apprenticed by Brazil (up 10.3% at CS to €260 million) and abiding by Established Rx articles and the Attenuate Ache franchise. Fourth-quarter sales in the Eurasia arena added 11.2% (up 3.1% at CS) to €329 actor accurate by able advance in Turkey. During the quarter, sales in Russia were €174 actor bottomward 8.2% at CS. In Africa and the Middle East, sales were €582 actor bottomward 3.6% and bottomward 2.5% at CS (which additionally excludes Maphar in Morocco) impacted by lower sales of Vaccines. In Emerging Markets, full-year 2017 sales added 6.0% at CS to €10,258 million.
Fourth-quarter sales in Europe were €2,467 million, up 15.8% or 3.7% at CS apprenticed by Vaccines (up 37.8% at CS), Attenuate Diseases (up 12.3%) and Assorted Sclerosis allotment (up 17.8%) which anniversary lower Established Rx Articles sales (down 6.1%). In Europe, full-year 2017 sales added 0.7% at CS to €9,525 million.
Sales in Japan added 9.3% to €416 actor in the fourth quarter. At CS, sales in Japan were bottomward 9.3% absorption all-encompassing Plavix® competition, calm with lower sales of Aprovel® and Vaccines. In Japan, full-year 2017 sales decreased 7.3% at CS to €1,803 million.
Sanofi presented its R&D action and avant-garde activity on December 13, 2017 which are abbreviated in the afterward columnist release: http://mediaroom.sanofi.com/sanofi-presents-rd-strategy-and-innovative-pipeline/
Regulatory updates aback December 13, 2017 accommodate the following:
At the alpha of February 2018, the R&D activity independent 70 projects including 36 new atomic entities and atypical vaccines in analytic development. 25 projects are in Appearance 3 or accept been submitted to the authoritative authorities for approval.
2017 fourth-quarter and full-year 2017 banking results(10)
Business Net Income(10)In the fourth division of 2017, Sanofi generated net sales of €8,691 million, a abatement of 2.0% (up 4.1% at CER). Full-year 2017 net sales were €35,055 million, up 3.6% on a appear abject (up 5.6% at CER).
Fourth-quarter added revenues decreased 6.5% (up 1.6% at CER) to €290 million, absorption VaxServe sales accession of non-Sanofi articles of €223 actor (up 10.0% at CER). In 2017, added revenues added 29.5% (up 32.9% at CER) to €1,149 million, absorption VaxServe sales accession of €859 actor (up 51.8% at CER).
Fourth-quarter Gross Accumulation decreased 5.4% to €5,883 actor (up 1.3% at CER). At CER and CS*, fourth-quarter Gross Accumulation decreased 3.7% and 2.6% excluding the appulse of Dengvagia®. The gross allowance arrangement was 67.7% against 70.2% in the fourth division of 2016. The absolute gross allowance appulse of assorted sclerosis franchise, Dupixent® and China was added than anniversary by the abrogating U.S. Diabetes net bulk evolution, the appulse of the Dengvagia®, lower sales of Pentacel® and Renagel® and bill variations. In the fourth quarter, the gross allowance arrangement of Pharmaceuticals was 70.1%, a abatement of 1.6 allotment credibility and the gross allowance arrangement of Vaccines was 54.9%, a abatement of 6.7 allotment points. In 2017, the gross allowance arrangement was 70.6%, a abatement of 0.4 allotment points.
Research and Development (R&D) costs added 1.9% to €1,464 actor in the fourth quarter. At CER, R&D costs added 6.3% absorption mainly the added spending on immuno-oncology programs and sotagliflozin. In 2017, R&D costs added 5.8% to €5,472 actor (up 7.0% at CER and up 5.0% at CER and CS*).
Fourth-quarter affairs accepted and authoritative costs (SG&A) were up 3.6% to €2,698 actor (up 9.6% at CER). At CER and CS*, SG&A costs were up 2.6% absorption immunology allotment barrage costs and added costs in China, which were partially anniversary by lower Diabetes spending in the U.S. Accepted costs decreased in the fourth quarter, apprenticed by bulk ascendancy measures. In the fourth quarter, the arrangement of SG&A to sales added 1.6 allotment credibility to 31.0% compared to the fourth division of 2016. In 2017, SG&A costs added 6.0% to €10,058 actor (up 7.8% at CER and up 0.4% at CER and CS*). In 2017, the arrangement of SG&A to sales added 0.7 allotment credibility to 28.7% compared to 2016.
Fourth-quarter added accepted operating assets net of costs was -€114 actor against -€78 actor in 2016. In the fourth division of 2017, this band included an crime of absolute assets of €87 actor accompanying to Dengvaxia®. In 2017, added accepted operating assets net of costs was €4 actor against -€127 actor in 2016.
The allotment of profits from assembly was €114 actor in the fourth division against €53 actor for the aloft aeon of 2016. The allotment of profits from assembly included Sanofi’s allotment in Regeneron profit. In the fourth division of 2016, this band included the allotment of accumulation of Sanofi Pasteur MSD for an bulk of €13 million. In 2017, the allotment of profits from assembly was €235 actor against €177 actor in 2016.
In the fourth quarter, non-controlling interests were -€30 actor against -€32 actor in the fourth division of 2016. In 2017, non-controlling interests were -€125 actor against -€113 actor in 2016.
Fourth-quarter business operating assets decreased 20.4% to €1,691 million. At CER, business operating assets decreased 14.0%. At CER and CS*, business operating assets decreased 18.5%, and 11.4% excluding the €158 actor appulse affiliated to Dengvaxia®. The arrangement of business operating assets to net sales decreased 4.5 allotment credibility to 19.5% against 2016. In the fourth quarter, the business operating assets arrangement of Pharmaceuticals was 20.3%, 2 allotment credibility lower and the business operating assets arrangement of Vaccines was 16.8%, 18.9 allotment credibility lower. Full-year 2017 business operating assets added 0.6% (or up 3.0% at CER) to €9,343 million. At CER and CS*, business operating assets decreased 1.1%. In 2017, the arrangement of business operating assets to net sales decreased 0.8 allotment credibility to 26.7%.
Net banking costs were €73 actor in the fourth division against €125 actor in the fourth division of 2016. Full-year 2017 net banking costs were €273 actor against €399 actor in 2016.
The fourth-quarter able tax bulk was 18.6% compared to 24.0% in the fourth division of 2016 absorption variances in the geographic contour mix. The full-year 2017 able tax bulk was 23.5% compared to 23.3% in 2016. Taken into anniversary an estimated net absolute appulse from the contempo U.S. tax ameliorate and abridgement of tax ante in assorted countries, Sanofi expects that the 2018 able tax bulk should be about 22%.
Fourth-quarter business net income(10) decreased 17.1% to €1,332 actor (down 10.8% at CER). The arrangement of business net assets to net sales decreased 1.9 allotment credibility to 15.3% against 2016 (excluding Beastly Bloom business). Full-year 2017 business net assets decreased 4.7% to €6,964 actor (down 2.6% at CER).(10) See Appendix 3 for 2017 fourth-quarter and 2017 circumscribed assets statement; see Appendix 10 for definitions of banking indicators, and Appendix 4 for adaptation of IFRS net assets appear to business net income. * Adapted for BI CHC business and abortion of SPMSD and others.
The arrangement of business net assets to net sales decreased 0.3 allotment credibility to 19.9% compared to 2016 (excluding Beastly Bloom business).
In 2017, business antithesis per share(10) was €5.54, bottomward 2.5% on a appear abject and bottomward 0.4% at CER. The boilerplate cardinal of shares outstanding was 1,256.9 actor against 1,286.6 actor in 2016.
Sanofi expects 2018 Business EPS to abound amid 2% and 5% at CER, including the advancing accession from the afresh appear acquisitions, barring abrupt aloft adverse events. Applying the boilerplate December 2017 barter rates, the bill appulse on 2018 Business EPS is estimated to be -3% to -4%.
The Board of Directors convened on February 6, 2018, and proposed a allotment of €3.03 per share.
Financial statements are not audited. The assay procedures by the Statutory Auditors are underway.
Reconciliation of IFRS net assets appear to business net assets (see Appendix 4)
In 2017, the IFRS net assets was €8,434 actor absorption the accretion of BI’s CHC business and abounding accord of Sanofi’s European vaccine operations. The basic items afar from the business net assets were:
(10) See Appendix 3 for 2017 fourth-quarter and 2017 circumscribed assets statement; see Appendix 10 for definitions of banking indicators, and Appendix 4 for adaptation of IFRS net assets appear to business net income.
In 2017, net banknote generated by operating activities was €6,715 actor afterwards basic expenditures of €1,500 actor and an admission in alive basic of €589 million. This net banknote breeze adjourned acquisitions and partnerships net of disposals (€1,053 million), restructuring costs and agnate items (€754 million) and the allotment paid by Sanofi (€3,710 million). The bandy amid BI CHC business and Sanofi Beastly Bloom business generated a net banknote breeze of €3,535 million, partially acclimated to accounts allotment repurchases (€2,158 million) over the period. Net debt decreased from €8,206 actor at December 31, 2016 to €5,229 actor at December 31, 2017 (amount net of €10,315 actor banknote and banknote equivalents).
(11) The U.S. Tax ameliorate impacts are basic based on the Company’s antecedent assay of the 2017 Act. The final appulse may alter and will be adapted appropriately during 2018, due to, amid added things, changes in the Company’s interpretations and assumptions as able-bodied as added advice from the U.S. legislators, the U.S.Internal Acquirement Services, the U.S. Securities and Barter Commission or the Banking Accounting Standards Board.
This columnist absolution contains avant-garde statements as authentic in the Private Securities Action Ameliorate Act of 1995, as amended. Avant-garde statements are statements that are not absolute facts. These statements accommodate projections and estimates and their basal assumptions, statements apropos plans, objectives, intentions and expectations with account to approaching banking results, events, operations, services, artefact development and potential, and statements apropos approaching performance. Avant-garde statements are about articular by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and agnate expressions. Although Sanofi’s administration believes that the expectations reflected in such avant-garde statements are reasonable, investors are cautioned that avant-garde advice and statements are accountable to assorted risks and uncertainties, abounding of which are difficult to adumbrate and about aloft the ascendancy of Sanofi, that could account absolute after-effects and developments to alter materially from those bidding in, or adumbrated or projected by, the avant-garde advice and statements. These risks and uncertainties accommodate amid added things, the uncertainties inherent in assay and development, approaching analytic abstracts and analysis, including column marketing, decisions by authoritative authorities, such as the FDA or the EMA, apropos whether and back to accept any drug, accessory or biological appliance that may be filed for any such artefact candidates as able-bodied as their decisions apropos labelling and added affairs that could affect the availability or bartering abeyant of such artefact candidates, the absence of agreement that the artefact candidates if accustomed will be commercially successful, the approaching approval and bartering success of ameliorative alternatives, Sanofi’s adeptness to account from alien advance opportunities, to complete accompanying affairs and/or access authoritative clearances, risks associated with bookish acreage and any accompanying awaiting or approaching action and the ultimate aftereffect of such litigation, trends in barter ante and prevailing absorption rates, airy bread-and-er conditions, the appulse of bulk ascendancy initiatives and consecutive changes thereto, the boilerplate cardinal of shares outstanding as able-bodied as those discussed or articular in the accessible filings with the SEC and the AMF fabricated by Sanofi, including those listed beneath “Risk Factors” and “Cautionary Anniversary Apropos Forward-Looking Statements” in Sanofi’s anniversary address on Form 20-F for the year concluded December 31, 2016. Added than as appropriate by applicative law, Sanofi does not undertake any obligation to amend or alter any avant-garde advice or statements.
List of appendices
Simplified circumscribed antithesis sheet
Expected R&D milestones
Appendix 1: 2017 fourth-quarter net sales by GBU, franchise, geographic arena and product
2017 net sales by GBU, franchise, geographic arena and product
Appendix 2: Business net assets statement
* Net of tax.** Determined on the abject of Business assets afore tax, assembly and non-controlling interests.*** Based on an boilerplate cardinal of shares outstanding of 1,252.9 actor in the fourth division of 2017 and 1,282.9 actor in the fourth division of 2016.
* Net of tax.** Determined on the abject of Business assets afore tax, assembly and non-controlling interests.***Based on an boilerplate cardinal of shares outstanding of 1,256.9 actor in 2017 and 1,286.6 actor in 2016.
Appendix 3: Circumscribed assets statements
(1) Beastly Bloom after-effects and accretion on auctioning appear alone in accordance with IFRS 5 (Non-Current Assets Captivated for Auction and Discontinued Operations).
Appendix 4: Adaptation of Net assets attributable to disinterestedness holders of Sanofi to Business net income
(1) Of which accompanying to acquittal bulk generated by the remeasurement of abstract assets as allotment of business combinations: €407 actor in the fourth division of 2017 and €374 actor in the fourth division of 2016.(2) In 2016, accretion on Sanofi Pasteur MSD advance in assembly and joint-ventures aloft abortion of the joint-venture.(3) In 2017, this band includes the appulse of changes in accumulated assets tax rates, mainly in France (25% accepted bulk able as of January 1, 2022).(4) In 2016, this curve includes the appulse on deferred tax assets and liabilities advancing from the adaptation items (in accurate acquittal and crime of abstract assets and restructuring costs).(5) In 2017, 562m€ action accretion on French 3% tax on assets and acting aberrant customs and US tax ameliorate (1,193)m€.(6) In 2017, net accretion consistent from the denial of the Beastly Bloom business (including the closing in Mexico in Q4-2017).(7) In 2016, includes the afterward items: appulse of the cessation of abrasion and crime of Property, Bulb & Accessories starting at IFRS 5 appliance (Non-current captivated for auction and discontinued operations), appulse of the acquittal and crime of abstract assets until IFRS 5 application, costs incurred as a aftereffect of the denial as able-bodied as the tax aftereffect of these items.(8) In 2016, includes the afterward items: appulse of the cessation of the disinterestedness accounting of the Sanofi Pasteur MSD business net assets aback the advertisement by Sanofi and Merck of their absorbed to end their collective vaccine operations in Europe.(9) Based on an boilerplate cardinal of shares outstanding of 1,252.9 actor in the fourth division of 2017 and 1,282.9 actor in the fourth division of 2016.
(1) Of which accompanying to acquittal bulk generated by the remeasurement of abstract assets as allotment of business combinations: €1,726 actor in 2017 and €1,550 actor in 2016.(2) In 2017, mainly acclimation to vendor’s agreement accouterment in affiliation with accomplished divestment.(3) In 2016, accretion on Sanofi Pasteur MSD advance in assembly and joint-ventures aloft abortion of the joint-venture.(4) In 2017, this band includes the appulse of changes in accumulated assets tax rates, mainly in France (25% accepted bulk able as of January 1, 2022).(5) In 2016, this curve includes the appulse on deferred tax assets and liabilities advancing from the adaptation items (in accurate acquittal and crime of abstract assets and restructuring costs).(6) In 2017, 451m€ action accretion on French 3% tax on assets and acting aberrant customs and US tax ameliorate (1,193)m€.(7) In 2017, net accretion consistent from the denial of the Beastly Bloom business (including the closing in Mexico in Q4-2017).(8) In 2016, includes the afterward items: appulse of the cessation of abrasion and crime of Property, Bulb & Accessories starting at IFRS 5 appliance (Non-current captivated for auction and discontinued operations), appulse of the acquittal and crime of abstract assets until IFRS 5 application, costs incurred as a aftereffect of the denial as able-bodied as the tax aftereffect of these items.(9) In 2016, includes the afterward items: appulse of the cessation of the disinterestedness accounting of the Sanofi Pasteur MSD business net assets aback the advertisement by Sanofi and Merck of their absorbed to end their collective vaccine operations in Europe.(10) Based on an boilerplate cardinal of shares outstanding of 1,256.9 actor in 2017 and 1,286.6 actor in 2016.
Appendix 5: Change in net debt
(1) Excluding restructuring costs and agnate items.(2) Excluding Beastly Bloom business for the 2016 allusive period.
Appendix 6: Simplified circumscribed antithesis sheet
Appendix 7: bill sensitivity
2018 Business EPS bill sensitivity
Currency acknowledgment on Q4 2017 sales
Currency boilerplate ante
Appendix 8: R&D Pipeline
O : Opt-in rights articles for which rights accept not been acclimatized yetR : Registration Abstraction (other than Appearance 3)
New Atomic Entities(*)
Expected Acquiescence Timeline(1)
(1) Excluding Appearance 1 – Abstracts accompanying to all studies appear on clinicaltrials.gov(2) Additionally accepted as SAR231893(3) Additionally accepted as SAR439684 and REGN2810 (4) Acid Sphingomyelinase Deficiency(5) Acquiescence action for the U.S. beneath evaluation(6) Analytic authority aerial by FDA appear on Dec 15, 2017 – Analytic balloon dosing to resume in Q1 2018. Afterward the Alnylam/Sanofi cardinal restructuring of the RNAi assay attenuate ache accord appear in January 2018, Sanofi will accept all-around rights on fitusiran. The transaction is accountable to accepted closing altitude and clearances, including approval beneath the Hart-Scott Rodino Antitrust Improvements Act(7) Additionally accepted as SAR439152 and as MYK461(8) Hypertrophic Cardiomyopathy(9) Gaucher Accompanying Parkinson’s Disease(10) Additionally accepted as SP0232 and MEDI8897(**) Partnered and/or in accord – Sanofi may accept bound or aggregate rights on some of these products
Pipeline Movements Aback Q3 2017
(1) Additionally accepted as PRN2246(2) Additionally accepted as SAR439684 and REGN2810(3) Afterward the Alnylam/Sanofi cardinal restructuring of the RNAi assay attenuate ache accord appear in January 2018, Alnylam will accept all-around rights on patisiran and Sanofi will accept royalties based on net sales of patisiran. The transaction is accountable to accepted closing altitude and clearances, including approval beneath the Hart-Scott Rodino Antitrust Improvements Act”. (**) Partnered and/or in accord – Sanofi may accept bound or aggregate rights on some of these products
Appendix 9: Accepted R&D milestones
Appendix 10: Definitions of non-GAAP banking indicators
“Company” corresponds to Sanofi and its subsidiaries
Company sales at connected barter ante (CER)
When we accredit to changes in our net sales “at connected barter rates” (CER), this agency that we exclude the aftereffect of changes in barter rates.
We annihilate the aftereffect of barter ante by recalculating net sales for the accordant aeon at the barter ante acclimated for the antecedent period.
Reconciliation of net sales to Company sales at connected barter ante for the fourth division and full-year 2017
Business net income
Sanofi publishes a key non-GAAP indicator.Business net assets is authentic as net assets attributable to disinterestedness holders of Sanofi excluding:
(1) Appear in the band items Restructuring costs and agnate items and Assets and losses on disposals, and litigation, which are authentic in Agenda B.20. to our circumscribed banking statements.(2) In 2016, appulse of cessation of abrasion and crime of Property, Bulb and Accessories starting at IFRS 5 appliance (non-current assets captivated for sales and discontinued operations), acquittal and crime of abstract assets until IFRS 5 appliance and costs incurred as a aftereffect of the denial as able-bodied as tax aftereffect of these items; and in 2017 accretion on the auctioning of the Beastly Bloom business, net of tax.
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