Following the advertisement of absolute negotiations with Boehringer Ingelheim and as per the IFRS 5 presentation claim for discontinued operations, net assets for Sanofi`s Beastly Bloom business (Merial) was appear on a abstracted band (“Net assets from the captivated for barter Beastly Bloom Business”) in the Circumscribed Assets Account for 2016 and the above-mentioned year. In the aboriginal three abode of 2016, Sanofi comments included Merial for every assets account band appliance the appellation “Aggregate”. Sanofi neither presents “Aggregate” abstracts nor belletrist Beastly Bloom business as an operating articulation in Q4 2016 and in 2016 as a aftereffect of the closing aboriginal in 2017 of the bandy of the Beastly Health/CHC business with Boehringer Ingelheim. 2016 net sales including Beastly Health(3) were €36,529 actor of which €9,466 actor in the fourth division of 2016.
(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 Addendum 11 for definitions). The circumscribed assets account for Q4 2016 and 2016 is provided in Addendum 4 and a adaptation of business net assets to IFRS net assets appear is set alternating in Addendum 3; (2) changes in net sales are bidding at connected barter ante (CER) unless contrarily adumbrated (see Addendum 11); (3) Merial advice is provided in addendum 5; (4) See folio 8; (5) 2016 Business EPS was €5.68.
In the fourth division of 2016, Aggregation sales were €8,867 million, up 3.3% on a appear basis. Barter bulk movements had a abrogating aftereffect of 0.1 allotment points. At CER, Aggregation sales added 3.4%.
In 2016, Aggregation sales were €33,821 million, bottomward 0.7% on a appear basis. Barter bulk movements had an abortive aftereffect of 1.9 allotment credibility absorption mainly the adverse change of the Argentine Peso, Chinese Yuan, Mexican Peso and British Pound, which added than account the absolute furnishings from the Japanese Yen. At CER, Aggregation sales added 1.2%.
2016 achievement included a abrogating bill appulse accompanying to the change of barter bulk activated for the adaptation of Venezuela operations, constant from the change of the barter arrangement in February 2016 as able-bodied as from the assiduous disability to barter Venezuelan ivars for U.S. dollars at the advantaged official rate. In addition, in the aboriginal bisected of 2015, Sanofi benefited from a cogent admission in artefact address in Venezuela, due to affairs patterns associated with bounded bazaar conditions. As a consequence, sales in Venezuela were €18 actor in 2016 compared to €455 actor in 2015. Excluding Venezuela, Aggregation sales added 3.7% and 2.6% in the fourth division and in 2016, respectively.
The table beneath presents sales by All-around Business Units (GBU) and reflects the alignment of Sanofi which became able as of January 1, 2016. This anatomy drives added specialization, simplifies advertisement and provides bright focus on advance drivers. Please agenda that in Emerging Markets, Specialty Care and Diabetes and Cardiovascular sales 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 Care; (c) Excluding Venezuela: -1.2%; (d) Excluding Venezuela: 1.4%; (e) Excluding Venezuela: 9.0%; (f) Excluding Venezuela: 2.6%
The tables beneath present fourth division and abounding year 2016 sales by all-around franchise, including Emerging Markets, to facilitate comparisons. Addendum 1 provides a adaptation of sales by GBU and franchise.
(6) See Addendum 11 for definitions of banking indicators.
(a) Excluding Venezuela : 17.6%; (b) Excluding Venezuela : 18.8%; (c) Excluding Venezuela : 0.2%; (d) Excluding Venezuela : 10.8%; (e) Excluding Venezuela : -4.9%; (f) Excluding Venezuela: 3.8%; (g) Excluding Venezuela: 1.4%; (h) Excluding Venezuela: -0.9%; (i) Excluding Venezuela: 2.5%; (j) Excluding Venezuela: 6.1%; (k) Excluding Venezuela: 9.0%; (l) Excluding Venezuela: 13.2%; (m) Excluding Venezuela: 2.6%; (n) Excluding Venezuela: 7.0%.
Fourth-quarter Pharmaceuticals sales added 3.4% to €7,515 actor apprenticed by Assorted Sclerosis, Attenuate Ache and Cardiovascular franchises. In 2016, Pharmaceuticals sales were up 0.2% to €29,244 million. Excluding Venezuela, 2016 sales Pharmaceuticals added 1.6%.
Rare Ache franchise
In the fourth quarter, Attenuate Ache sales added 9.7% to €716 actor apprenticed by the accretion of patients common and able achievement of the authorization in Emerging Markets. In 2016, Attenuate Ache sales were up 11.7% to €2,777 million.
In the fourth quarter, Gaucher (Cerezyme® and Cerdelga®) sales added 9.9% to €213 million, apprenticed by Cerezyme® advance in Emerging Markets (up 34.7% to €57 million) and the accretion addition of Cerdelga® (€29 million, up 27.3%). In 2016, Gaucher sales added 9.6% to €854 million.
Sales of Fabrazyme® were up 13.9% to €182 actor in the fourth quarter, due to a connected accretion of new patients. In 2016, sales of Fabrazyme® were up 14.7% to €674 million.
Fourth-quarter Myozyme®/Lumizyme® sales added 15.6% to €192 million, mainly due to new accommodating accruals and added common diagnosis. In 2016, sales of Myozyme®/Lumizyme® added 13.5% to €725 million.
Multiple Sclerosis franchise
Fourth-quarter Assorted Sclerosis (MS) sales added 37.1% to €484 million, absorption able Aubagio® and Lemtrada® achievement in the U.S. and Europe as able-bodied as the accretion sales addition from Emerging Markets and the Rest of the World. In 2016, MS sales were up 56.1% to €1,720 million.
In the fourth quarter, Aubagio® sales added 34.2% to €367 actor apprenticed by the U.S. (up 34.5% to €265 million) and Europe (up 31.7% to €79 million). Aubagio® is currently the fastest growing articulate ache modifying assay in the Assorted Sclerosis bazaar with decree allotment of 8.8% in the U.S. (IMS NPA TRX -Q4 2016). In 2016, Aubagio® sales were up 49.7% to €1,295 million.
Fourth-quarter Lemtrada® sales added 46.9% to €117 million, including €67 actor in the U.S. (up 50.0%) and €39 actor in Europe (up 41.4%). In 2016, Lemtrada® sales were up 79.0% to €425 million.
Fourth-quarter Oncology sales decreased 3.9% to €369 million. Advance of Jevtana®, Thymoglobulin® and Mozobil® was account by lower Taxotere® and Eloxatin® sales. In 2016, Oncology sales were €1,453 million, bottomward 2.2%.
Jevtana® sales were up 8.3% to €92 actor in the fourth division led by Europe (up 12.5% to €35 million) and Japan. Full-year Jevtana® sales were up 11.5% to €358 million.
In the fourth quarter, Thymoglobulin® sales were up 10.1% to €77 actor accurate by the achievement in the U.S. (up 16.2% to €43 million). In 2016, Thymoglobulin® sales were up 10.9% to €281 million.
Fourth-quarter Eloxatin® sales were bottomward 27.6% to €41 actor absorption all-encompassing antagonism in Canada. Over the aforementioned period, Taxotere® sales decreased 12.2% (to €42 million) due to connected all-encompassing antagonism in Japan. In 2016, Taxotere® and Eloxatin® sales were bottomward 17.1% (€179 million) and 21.6% (€170 million), respectively.
(a) Excluding Venezuela: -1.2%;
In the fourth quarter, Diabetes sales added 1.9% to €1,945 million, including lower Lantus® sales in the U.S. Fourth-quarter U.S. Diabetes sales were up 5.5% to €1,131 million. Sales in Emerging Markets added 4.1% to €365 million. Sales in Europe were €318 million, a abatement of 5.6%. In 2016, Diabetes sales were €7,341 million, bottomward 1.8%.
Fourth-quarter sales of Sanofi glargine (Lantus® and Toujeo®) added 3.5% to €1,701 million. In the U.S., Sanofi glargine sales of €1,100 actor were up 7.0%. In Europe, Sanofi glargine sales decreased 5.4% to €240 actor due to biosimilar antagonism in several European markets. In 2016, Sanofi glargine sales were €6,363 million, bottomward 1.8%.
Over the quarter, Lantus® sales were €1,463 actor bottomward 5.1%. In the U.S., Lantus® sales decreased 1.8% to €931 actor mainly absorption lower boilerplate net bulk and patients switching to Toujeo®. In Europe, fourth-quarter Lantus® sales were €199 actor (down 17.4%) due to biosimilar antagonism and patients switching to Toujeo®. In Emerging Markets, sales were abiding at €243 actor impacted by lower sales in Russia. In 2016, Lantus® sales were €5,714 million, bottomward 9.4%.
Fourth-quarter Toujeo® sales were €238 actor of which €169 actor were recorded in the U.S. and €41million in Europe. The all-around roll-out of this artefact continues and Toujeo® is accessible in 45 countries. In Japan, the two-week decree absolute was aerial in September 2016, constant in a cogent admission in bazaar allotment (10.8% in December 2016- based on IMS basal insulin allotment bazaar in value). Full-year Toujeo® sales were €649 actor (versus €164 actor in 2015).
Amaryl® sales were €89 million, bottomward 1.1% in the fourth quarter, of which €73 actor were generated in Emerging Markets (up 4.1%). In 2016, Amaryl® sales were €362 million, bottomward 3.8%.
Fourth-quarter Apidra® sales decreased 9.6% to €95 million, absorption lower sales in the U.S. (down 31.0% to €29 million) and Europe (down 6.1% to €32 million), which account the achievement in Emerging Markets (up 33.3% to €22 million). In 2016, Apidra® sales decreased 1.1% to €367 million.
Since January 2017, Soliqua(TM) 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection; lixisenatide was in-licensed from Zealand Pharma) has been accessible in the U.S. Soliqua 100/33 is adumbrated for the assay of adults with blazon 2 diabetes clumsily controlled on basal insulin (less than 60 Units daily) or lixisenatide. Sanofi is alms Soliqua(TM) 100/33 at a $0 co-pay (see columnist absolution from January 4, 2017) for acceptable U.S. patients with bartering allowance and is alive to defended bazaar admission from payers. Sanofi is additionally alms a tailored abutment program, Soliqua(TM) 100/33 COACH, at no bulk to patients who accept been assigned the product.
Praluent® (alirocumab, accord with Regeneron) was launched in the U.S., in a cardinal of European markets and Japan in 2015 and 2016. Fourth-quarter Praluent® sales were €37 actor of which €30 actor were in the U.S. and €6 actor in Europe. Full-year Praluent® sales were €105 actor absorption cogent payer appliance administration restrictions in the U.S. and bound bazaar admission in Europe.
In January 2017, the U.S. District Court for the District of Delaware issued an admonition that requires Sanofi and Regeneron to stop marketing, affairs and accomplishment Praluent® in the U.S. starting from February 21, 2017. Until that date, Praluent® charcoal accessible in the U.S. Sanofi and Regeneron filed a motion with the United States Court of Appeals for the Federal Circuit to break (suspend) the admonition awaiting the address of the acumen advancement the authority of Amgen`s patents for antibodies targeting PCSK9 as able-bodied as the admonition ruling.
Fourth-quarter and 2016 Multaq® sales were €94 actor (up 10.6%) and €353 actor (up 3.8%), respectively.
Established Rx Products
(a) Excluding Venezuela: -1.1%; (b) Excluding Venezuela: -17.1%; (c) Excluding Venezuela: -0.7%; (d) Excluding Venezuela: 0.5%; (e) Excluding Venezuela: -2.3%; (f) Excluding Venezuela: -3.2%; (g) Excluding Venezuela: -4.9%;
In the fourth quarter, Established Rx Articles sales decreased 1.3% to €2,568 million, absorption all-encompassing antagonism to Plavix® in Japan, and the low base for allegory from the anamnesis of Auvi-Q® in the fourth division of 2015. In Emerging Markets, Established Rx Articles sales added 0.9% to €946 actor apprenticed by the achievement of Lovenox®. In the U.S., Established Rx Articles sales added 22.4% (to €371 million) mainly due to the low base for allegory from the anamnesis Auvi-Q® in the above-mentioned period. In Europe, Established Rx Articles sales decreased 3.3% to €911 million. Full-year Established Rx Articles sales decreased 6.8% to €10,311 actor and 4.9% excluding Venezuela.
Lovenox® sales added 0.7% to €414 actor in the fourth quarter, apprenticed by able achievement in Emerging Markets (up 12.2% to €124 million), which account the appulse of all-encompassing antagonism in the U.S. (down 27.8% to €13 million) and lower sales in Europe (down 1.5% to €255 million). In September, two enoxaparin biosimilars were accustomed in the European Union. In 2016, Lovenox® sales were €1,636 million, bottomward 1.7%.
In the fourth quarter, Plavix® sales were bottomward 20.0% to €363 actor due to all-encompassing antagonism in Japan that started in June 2015 (sales in Japan were bottomward 49.3% to €82 million). In 2016, Plavix® sales decreased 18.8% to €1,544 million.
Fourth-quarter Renvela®/Renagel® sales decreased 2.5% to €235 million. In the U.S. area Sanofi expects all-encompassing antagonism in the aboriginal bisected of 2017, fourth-quarter sales were bottomward 0.5% to €194 million. In Europe, Renvela®/Renagel® sales were bottomward 24.0% to €19 actor due to all-encompassing competition. Full-year Renvela®/Renagel® sales were bottomward 1.1% to €922 million.
Aprovel®/Avapro® sales were bottomward 1.8% (to €163 million) and bottomward 7.0% (to €681 million) in the fourth division and the abounding year, respectively.
In the fourth division of 2015, Sanofi recalled Auvi-Q®/Allerject® in the U.S. and Canada. The abrogating appulse of this anamnesis on sales was -€122 million, which corresponded mainly to the changeabout of sales of the artefact back the alpha of 2015. Sanofi no best commercializes this artefact and no sales were recorded in 2016.
(a) Excluding Venezuela: 1.4%;
In the fourth quarter, Customer Healthcare (CHC) sales added 2.7% to €834 actor apprenticed by the achievement in Europe, absorption an aboriginal ahem and algid season, partially account by lower sales in Russia. Excluding the denial of several baby products, sales of CHC were up 3.2% in the fourth quarter.
Fourth-quarter CHC sales in the U.S. added 4.6% to €209 actor admitting added aggressive ambiance in the abhorrence category. In Emerging Markets, sales decreased 3.2% to €326 actor absorption lower sales in Russia due to the arduous bounded bread-and-er situation. In the quarter, sales in Europe were up 9.5% to €229 actor due an aboriginal alpha of ahem and algid season, mainly in France, admitting the divesture of baby products. Adjusting for these divestitures, CHC sales in Europe were up 11.1% in the fourth quarter. Full-year CHC sales accomplished €3,330 million, bottomward 1.6% (up 2.7% excluding Venezuela and the denial of several baby products).
Sanofi and Boehringer Ingelheim afresh appear that the barter of Sanofi`s beastly bloom business (Merial) and Boehringer Ingelheim`s customer healthcare (CHC) business was auspiciously bankrupt in best markets on January 1st 2017. The closing of the auctioning of Merial in Mexico and the bandy of Merial and CHC in India accept been delayed awaiting cancellation of assertive authoritative approvals. The affairs in both countries are accustomed to aing aboriginal 2017.
In the fourth quarter, Generics sales added 0.2% to €468 actor apprenticed by Emerging Markets (up 5.1% to €209 million) and Japan, which added than account for the U.S. (down 6.8% to €43 million) and Europe (down 6.6% to €192 million). In 2016, Generics sales were up 0.7% to €1,854 actor (up 2.5% excluding Venezuela).
As appear in our 2020 cardinal roadmap, Sanofi has anxiously advised all options for our Generics business in Europe and afresh fabricated the absolute accommodation to admit a carve-out action accustomed to be completed by the end of 2018. Importantly, Sanofi confirms its allegation to Generics in added genitalia of the apple with a greater focus on the Emerging Markets.
*Comparability based on the new presentation of VaxServe sales (see below) (a) Excluding Venezuela: 9.0%;
Fourth division circumscribed Vaccines sales were up 3.7% to €1,352 actor mainly apprenticed by the Polio/Pertussis/Hib (PPH) authorization both in the U.S. (total US sales up 7.8% to €704 million) and in Emerging Markets (total Emerging Markets sales up 7.3% to €521 million) admitting aboriginal flu shipments in the U.S. in the third quarter. In Europe, vaccines sales were bottomward 46.3% to €44 actor mainly absorption both (i) accumulation issues with Repevax® and (ii) sales from Sanofi to Sanofi Pasteur MSD deferred to 2017 in affiliation with the buy-back of account as allotment of the abortion of Sanofi Pasteur MSD joint-venture. In 2016, sales of Sanofi Pasteur added 8.8% to €4,577 actor mainly apprenticed by the PPH franchise, the allowances from our flu adverse action and, to a bottom extent, the dengue launch.
In the fourth quarter, Polio/Pertussis/Hib vaccines sales added 16.5% to €544 actor absorption accumulation improvements of Pentacel® in the U.S. (€119 actor adjoin €53 actor in the fourth division of 2015). Customer allocations for Pentacel® were removed in December 2016 and both clandestine and accessible channels accept now abounding admission to Pentacel to accommodated their needs. In Emerging Markets, PPH sales added 5.1% to €304 actor apprenticed by the advance of Hexaxim®, partially account by the appulse of bounded bazaar disruption in China. Full-year PPH sales were up 12.7% to €1,495 million.
Fourth-quarter Affliction vaccines sales were bottomward 5.3% to €416 actor due to aboriginal shipments in the U.S. in the third quarter. Sales of Affliction vaccines were bottomward 14.0% to €280 actor in the U.S. in the fourth quarter. In 2016, Affliction vaccines sales added 16.6% to €1,521 million, absorption Sanofi Pasteur`s action to action a portfolio of differentiated affliction vaccines. 2016 was a new almanac year for the Affliction authorization of Sanofi Pasteur.
Adult Booster vaccines sales decreased 15.3% to €129 actor in the fourth quarter, as a aftereffect of lower sales in Europe due to a Repevax® accumulation disruption. In the U.S. developed Booster vaccines sales were bottomward 2.0% to €100 million. Full-year sales of Developed Booster vaccines decreased 15.5% to €417 actor mainly apprenticed by accumulation issues with Repevax® and added aggressive burden appear Adacel® in the US.
Dengvaxia®, the world`s aboriginal dengue vaccine, is now accustomed in 14 countries (Bolivia, Brazil, Cambodia, Costa Rica, El Salvador, Guatemala, Indonesia, Mexico, Paraguay, Peru, Thailand, Singapore Venezuela and the Philippines). As expected, sales of Dengvaxia® were bound (€5 million) in the fourth division as no new immunization programs were implemented. These sales were generated in the clandestine bazaar and by the accessible anesthetic affairs launched in Paraná State in Brazil in the third quarter. In 2016, Dengvaxia® sales were €55 million.
Fourth-quarter Menactra® sales were up 1.0% to €107 million, €93 actor of which was generated in the U.S (up 7.1%) absorption the bazaar administration of Menactra®. In 2016, sales of Menactra® added 4.8% to €586 million.
Fourth-quarter and full-year 2016 Biking and added ancient vaccines sales were €107 actor (up 4.0%) and €368 actor (down 0.8%), respectively.
In the fourth quarter, Sanofi Pasteur MSD, the collective adventure with Merck & Co. in Europe, sales (not consolidated) added 25.5% (on a appear basis) to €301 million. Excluding the 2016 anniversary inventories repurchase to both ancestor companies, sales were flat, the advance of Hexyon® (pediatric hexavalent vaccine) and biking vaccines sales actuality abundantly account by lower Affliction and boosters vaccines sales. In 2016, sales of Sanofi Pasteur MSD were up 14.1% (on a appear basis) to €940 actor (including the auctioning of 2016 anniversary inventories to both ancestor companies).
As ahead announced, on January 2, 2017, Sanofi Pasteur and MSD afar their vaccine collective adventure in Europe in acclimation to accompany their own vaccine strategies and accommodate their corresponding European vaccines businesses into their own operations.
Company sales by geographic region
(a) Apple excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico(b) India, Pakistan, 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. added 11.3% to €3,321 actor apprenticed mainly by bifold chiffre advance of the assorted sclerosis authorization (up 37.4%) and Established articles (up 22.4%), absorption the low base for allegory from the appulse (-€122 million) of the anamnesis of Auvi-Q® in the fourth division of 2015. Advance in the fourth division additionally benefited from the achievement of the Attenuate ache (up 7.7%), Oncology (up 5.0%), CHC (up 4.6%) and Vaccines (up 7.8%) franchises. The U.S. sales achievement included advance of diabetes authorization (up 5.5%), aided by a low base for allegory in the fourth division 2015. In 2016, sales in the U.S. added 5.1% to €12,391 million.
Sales in Emerging Markets added 3.5% to €2,602 actor in the fourth division apprenticed by Attenuate Ache (up 23.5%), Diabetes (up 4.1%), Generics (up 5.1%) and Vaccines (up 7.3%). In the Asia region, fourth-quarter sales decreased 2.8% to €782 actor absorption lower sales in China (down 10.5% to €496 million), primarily impacted by bounded vaccines bazaar disruption and account fluctuation. In Latin America, fourth-quarter sales added 4.2% to €710 actor apprenticed by sales in Argentina and Brazil. Fourth-quarter sales in Brazil added 5.6% to €244 actor accurate by achievement of Vaccines and Established products. Fourth-quarter sales in the Eurasia arena added 8.4% to €329 actor accurate by able advance in Turkey and Ukraine. Over the quarter, sales in Russia alternate to advance (up 3.0% to €178 million). In Africa, the Middle-East and South Asia, sales were up 11.4% to €752 actor abiding by bifold chiffre advance in Middle-East, Africa and India. In 2016, sales in Emerging Markets added 2.4% to €9,593 million. Excluding Venezuela, 2016 sales in Emerging Markets grew 7.0%. 2016 sales in China, Brazil and Russia were €2,039 actor (up 0.5%), €983 actor (up 1.7%), €499 actor (down 7.1%), respectively.
Fourth-quarter sales in Europe were bottomward 1.7% to €2,134 million. The achievement of assorted sclerosis (up 34.8%), Attenuate ache (up 4.5%) and CHC (up 9.5%) were account by lower sales in Diabetes (down 5.6%), Established Rx Articles (down 3.3%) and Vaccines (down 46.3%). In 2016, sales in Europe added 0.6% to €8,679 million.
Sales in Japan decreased 22.2% to €428 actor in the fourth quarter, impacted by all-encompassing Plavix® antagonism (down 49.3% to €82 million). In Japan, 2016 sales decreased 24.8% to €1,688 million.
Regulatory updates back the advertisement of the third division after-effects on October 28, 2016 accommodate the following:
At the alpha of February 2017, the R&D activity absolute 44 biologic new atomic entities (excluding Life Cycle Management) and vaccine candidates in analytic development of which 13 are in Phase 3 or accept been submitted to the authoritative authorities for approval.
On December 28th, 2016, Hanmi and Sanofi entered into an alteration to their antecedent authorization acceding accomplished for the development of a portfolio of long-acting diabetes treatments. Sanofi alternate to Hanmi the rights accompanying to the account long-acting insulin to primarily focus on development of the account GLP-1 (efpeglenatide). Hanmi will booty the development advance on the account insulin and will accept albatross for the development of the long-acting account efpeglenatide/insulin biologic aggregate for a assertive aeon of time, afterwards which Sanofi will re-assume albatross for development.
2016 fourth-quarter and full-year banking results(7)
Business Net Income(7)
In the fourth division of 2016, Sanofi generated sales of €8,867 million, an admission of 3.3% (up 3.4% at CER). 2016 sales were €33,821 million, bottomward 0.7% (up 1.2% at CER).
Fourth-quarter added revenues added 31.9% to €310 actor and accommodate VaxServe sales of non-Sanofi articles (up 62.5% to €221 million) afterward the change in presentation as of January 1, 2016(7). 2016 added revenues added 10.7% to €887 actor of which €581 actor were generated by VaxServe (up 20.5%).
Fourth-quarter Gross Accumulation added 4.5% to €6,221 actor (up 4.5% at CER). The gross allowance arrangement bigger by 0.8 allotment credibility to 70.2% adjoin the fourth division of 2015, absorption mainly the absolute appulse of Aubagio® and attenuate ache franchise, the low base for allegory in the fourth division of 2015 from the anamnesis of Auvi-Q® and Medicaid delayed bills accompanying to Lantus® as able-bodied as automated abundance improvements. In 2016, the gross allowance arrangement bigger by 0.7 allotment credibility to 71.0% adjoin 2015, apprenticed by the able achievement of Sanofi Genzyme. In 2016, the gross allowance arrangement of Pharmaceuticals was 72.4%, an advance of 0.9 allotment credibility and the gross allowance arrangement of Vaccines was abiding at 62.0%. Sanofi expects its gross allowance arrangement to be approximatively 70% at CER in 2017.
Research and Development costs were up 5.4% to €1,437 million, (up 4.7% at CER) in the fourth quarter. This admission reflected the alpha of several Phase 3 programs abnormally isatuximab, as able-bodied as advancing Toujeo® studies. In 2016, the arrangement of R&D to sales was 0.4 allotment credibility college at 15.3% compared to the aforementioned aeon of 2015.
Selling accepted and authoritative costs (SG&A) added 4.9% to €2,603 actor in the fourth quarter. At CER, SG&A was up 4.8% mainly absorption pre-launch costs for Kevzara(TM) and Dupixent(TM), as able-bodied as ancient costs affiliated to the pre-integration of Boehringer Ingelheim CHC business. The arrangement of SG&A to sales added 0.5 allotment credibility to 29.4% compared with the fourth division of 2015. In 2016, the arrangement of SG&A to sales was 0.5 allotment credibility college at 28.0% compared with 2015 mainly due to barrage costs of new products.
Fourth-quarter added accepted operating assets net of costs was -€78 actor adjoin €24 actor for the aforementioned aeon of 2015. In the fourth division of 2016, this band included a adopted barter accident affiliated to our operation in Egypt. In 2016, added accepted operating assets net of costs was -€127 actor adjoin -€208 actor in 2015.
The allotment of profits from assembly was €53 actor in the fourth division adjoin €31 actor for the aforementioned aeon of 2015. The allotment of profits from assembly included Sanofi`s allotment in Regeneron accumulation as able-bodied as Sanofi`s allotment of accumulation in Sanofi Pasteur MSD (the Vaccines collective adventure with Merck & Co. in Europe). In 2016, the allotment of profits from assembly was €177 actor adjoin €169 actor in 2015.
In the fourth quarter, non-controlling interests were -€32 actor adjoin -€39 actor in the fourth division of 2015. In 2016, non-controlling interests were -€113 actor adjoin -€126 actor in 2015.
Fourth-quarter business operating assets was abiding at €2,124 million. At CER, business operating assets added 3.7%. The arrangement of business operating assets to net sales decreased 0.7 allotment point to 24.0% adjoin the aforementioned aeon of 2015. In 2016, business operating assets decreased 0.3% to €9,285 actor (or up 3.1% at CER). In 2016, the arrangement of business operating assets to net sales added 0.2 allotment point to 27.5%. In 2016, the business operating assets arrangement of Pharmaceuticals was 26.8%, 0.1 allotment credibility lower and the business operating assets arrangement of vaccines bigger 1.2 allotment credibility to 34.4%.
Net banking costs were €125 actor in the fourth division adjoin €73 actor in the fourth division of 2015 which included disposals and reassessments of banking assets. Full-year net banking costs were €399 actor adjoin €381 actor in 2015.
Fourth-quarter able tax bulk (without Beastly Health) was 24.0% compared with 17.4% in 2015. The 2015 tax reflected the furnishings of the modification in France of the taxation of dividend. In 2016, the able tax bulk was 23.3% adjoin 21.7% in 2015.
Fourth-quarter and full-year 2016 business net assets of Merial was €81 actor (versus €17 actor in the aforementioned aeon of 2015) and €476 actor (versus €368 actor in 2015), respectively.
(7) See Addendum 4 for 2016 fourth-quarter and 2016 Circumscribed assets statement; see Addendum 11 for definitions of banking indicators, and Addendum 3 for adaptation of business net assets to IFRS net assets reported
Fourth-quarter business net income(7) decreased 6.0% to €1,606 actor (down 2.9% at CER). In 2016, business net assets decreased 0.9% to €7,308 million, (up 2.5% at CER).
In 2016, Sanofi delivered about €650 actor of bulk accumulation which was abundantly reinvested to abutment advance initiatives. Sanofi expects that bulk accumulation will adeptness €1.3 billion in 2017 and the aggregation confirms that it charcoal on clue to bear at atomic €1.5 billion of bulk accumulation by 2018.
Sanofi expects 2017 Business EPS to be abiding to -3% at CER, barring abrupt aloft adverse events, constant with its ahead appear Cardinal Roadmap advice for the 2016-17 period. Applying the boilerplate December 2016 barter rates, the bill appulse on 2017 Business EPS is estimated to be 3% to 4%.
The Board of Directors convened on February 7, 2017, and proposed a allotment of €2.96 per share.
From business net assets to IFRS net assets appear (see Addendum 3)
In 2016, the basic reconciling items amid business net assets and IFRS net assets appear were:
(7) See Addendum 4 for 2016 fourth-quarter and 2016 Circumscribed assets statement; see Addendum 11 for definitions of banking indicators, and Addendum 3 for adaptation of business net assets to IFRS net assets reported
In 2016, net banknote generated by operating activities decreased 4.1% to €7,798 actor afterwards basic expenditures of €1,486 actor and an admission in alive basic of €610 million. This net banknote breeze partially adjourned acquisitions and partnerships net of disposals (€936 million), restructuring costs and agnate items (€729 million), the allotment paid by Sanofi (€3,759 million) and college allotment repurchases (€2,908 million) in apprehension of the banknote to be accustomed as allotment of the asset bandy with Boehringer Ingelheim. As a consequence, net debt added from €7,254 actor at December 31, 2015 to €8,206 actor (excluding Merial) at December 31, 2016 (amount net of €10,273 actor banknote and banknote equivalents).
This columnist absolution contains advanced statements as authentic in the Clandestine Securities Action Reform Act of 1995, as amended. Advanced 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. Advanced 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 advanced statements are reasonable, investors are cautioned that advanced advice and statements are accountable to assorted risks and uncertainties, abounding of which are difficult to adumbrate and about above 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 advanced 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 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 Account Apropos Forward-Looking Statements” in Sanofi`s anniversary address on Form 20-F for the year concluded December 31, 2015. Added than as appropriate by applicative law, Sanofi does not undertake any obligation to amend or alter any advanced advice or statements.
AppendicesFinancial statements are not audited. The analysis procedures by the Statutory Auditors are underway.
List of appendices
Change in net debt
Simplified circumscribed antithesis sheet
Expected R&D milestones
Definitions of non-GAAP banking indicators
Appendix 1: 2016 fourth-quarter net sales by GBU, franchise, geographic arena and product
Appendix 1: 2016 net sales by GBU, franchise, geographic arena and product
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