Paris, October 28, 2016
`
`Sanofi Announces Strong Q3 2016 Results
`
`Q3 2016
`
`Change
`
`Change (CER)
`
`9M 2016
`
`Change
`
`Change (CER)
`
`IFRS net sales reported
`IFRS net income reported
`IFRS EPS reported
`Aggregate Company sales(1)
`Business net income(2)
`Business EPS(2)
`
`€9,028m
`€1,674m
`€1.30
`€9,652m
`€2,300m
`€1.79
`
`+2.0%
`
`+2.8%
`
`+4.0%
`
`+2.1%
`
`+9.7%
`
`+11.2%
`
`+3.0%
`
`+3.0%
`
`+11.1%
`
`+12.4%
`
`€24,954m
`€3,919m
`€3.04
`€27,063m
`€5,702m
`€4.43
`
`-2.1%
`
`-0.9%
`
`+0.3%
`
`-1.3%
`
`+0.7%
`
`+2.3%
`
`+0.5%
`
`+1.2%
`
`+4.1%
`
`+5.8%
`
`Following the announcement of exclusive negotiations with Boehringer Ingelheim and as per the IFRS 5 presentation requirement for discontinued
`operations, net income for Sanofi's Animal Health business (Merial) will be reported on a separate line (“Net income from the held for exchange
`Animal Health Business”) in the Consolidated Income Statement for Q3 2016 and for 9M 2016, and the prior year. As of September 30 2016, Sanofi
`continues to report the performance of the Animal Health business, which remained an operating segment consistent with IFRS 8 and was included in
`the key performance indicators of the Company.
`
`2016 guidance raised on strong third-quarter financial results
` Aggregate Company sales(1) increased 3.0%(3) (up 2.1% at 2016 exchange rates) to €9,652 million.
` IFRS EPS reported was up 4.0% to €1.30.
` Business EPS(2) was up 12.4% at CER to €1.79 and up 11.2% on a reported basis.
` Given the performance in the first nine months, Sanofi now expects 2016 Business EPS(2) to grow between 3%
`and 5%(4) at CER, barring unforeseen major adverse events.
`
`Continuing to execute the simplification of the portfolio consistent with our 2020 Roadmap
` Decision to initiate a carve-out process in order to divest the EU Generics business within 12-24 months.
` CHC asset swap with Boehringer Ingelheim on track to close around year-end.
` Cost savings now expected to be at least €1.5 billion by 2018.
`
`Initiating a €3.5 billion share repurchase program to be completed by the end of 2017
`
`Solid sales performance despite continuing headwinds in diabetes and the Plavix LOE in Japan
` Sanofi Genzyme (Specialty Care) GBU continues to deliver double-digit growth (+16.9%).
` Sanofi Pasteur grew 14.4% supported by early flu vaccines shipment in the U.S.
` Diabetes and Cardiovascular GBU sales decreased 2.5%. Global diabetes franchise sales declined 1.5%.
` Aggregate sales in Emerging Markets(5) grew 5.6% driven by Diabetes and Rare Disease portfolios.
`
`Major launches and regulatory updates
` Toujeo® generated worldwide sales of €167 million. LixiLan PDUFA date extended to November 2016.
` Praluent® now approved in 41 countries.
` Dengvaxia® generated sales of €30 million and is now approved in 13 countries.
` Sarilumab: CGMP(6) observations during an FDA inspection of a Sanofi “fill-finish” facility could impact approval timing.
` Dupixent® (dupilumab) BLA accepted for priority review by U.S. FDA with March 29, 2017 PDUFA date.
`
`Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
`“We have generated solid sales momentum in the third quarter and seen a strong contribution to our financial
`performance from savings and efficiencies arising from our more focused organization. As a result, we are able to
`increase our FY 2016 Business EPS guidance. In addition, we have continued to work diligently to progress our major
`launches and the pipeline. With the filing of Dupixent®, we now have another important product under FDA review
`which we believe will enhance Sanofi’s growth profile in the coming years.”
`
`(1) Including Merial (see Appendix 8 for definition of Aggregate Company sales) which is reported on a single line in the consolidated income statements in accordance with
`IFRS 5 (Non-current assets held for sale and discontinued operations). Additionally, Sanofi comments include Merial for every income statement line using the term
`“Aggregate”; (2) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-
`
`GAAP financial measure (see Appendix 8 for definitions). The consolidated income statement for Q3 2016 and 9M 2016 is provided in Appendix 4 and a reconciliation of
`
`business net income to IFRS net income reported is set forth in Appendix 3; (3) Percentage changes in net sales and Aggregate sales are expressed at constant exchange
`rates (CER) unless otherwise indicated (see Appendix 8); (4) 2015 Business EPS was €5.64; (5) See page 8; (6) Current Good Manufacturing Practice
`
`Investor Relations: (+) 33 1 53 77 45 45 - E-mail: IR@sanofi.com - Media Relations: (+) 33 1 53 77 46 46 - E-mail: MR@sanofi.com
`Website: www.sanofi.com Mobile app: SANOFI IR available on the App Store and Google Play
`
`1
`
`AVENTIS EXHIBIT 2178
`Mylan v. Aventis, IPR2016-00712
`
`

`
`2016 third-quarter and nine-month Aggregate Sanofi sales
`
`
`Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(7).
`
`
`In the third quarter of 2016, Aggregate Company sales were €9,652 million, up 2.1% at 2016 exchange rates. Exchange
`rate movements had a negative effect of 0.9 percentage points, primarily reflecting the adverse evolution of the
`Argentine Peso, Chinese Yuan, and British Pound, which more than offset the positive effects from the Japanese Yen
`and Brazilian Real. At CER, Aggregate Company sales increased 3.0%. Year-to-date Aggregate Company sales
`reached €27,063 million, down 1.3% at 2016 exchange rates. Exchange rate movements had an unfavorable effect of
`2.5 percentage points.
`
`The first nine months performance included a negative currency impact related to the change of exchange rate applied
`for the translation of Venezuela operations, resulting from the evolution of the exchange system in February 2016 as well
`as from the persistent inability to exchange Venezuelan bolivars for U.S. dollars at the privileged official rate. In addition,
`in the first half of 2015, Sanofi benefited from a significant increase in product demand in Venezuela, due to buying
`patterns associated with local market conditions. As a consequence, sales in Venezuela were €9 million in the first nine
`months of 2016 compared to €423 million in the first nine months of 2015 (no sales were recorded in the third quarter of
`2016 compared to €24 million in the third quarter of 2015). Excluding Venezuela, Aggregate Company sales increased
`3.3% and 2.8% in the third quarter and first nine months of 2016, respectively.
`
`Global Business Units
`
`The table below presents sales by Global Business Units (GBU) and reflects the organization of Sanofi which became
`effective as of January 1, 2016. In this organizational structure, all Pharmaceutical sales in Emerging Markets are now
`included in the General Medicines and Emerging Markets GBU. This new reporting structure simplifies Sanofi, deepens
`specialization and allows clear focus on growth drivers.
`
`
`Net Sales by GBU
`(€ million)
`
`Sanofi Genzyme (Specialty Care)(a)
`
`Diabetes and Cardiovascular(a)
`
`General Medicines & Emerging Markets(b)
`
`Sanofi Pasteur (Vaccines)
`
`Merial (Animal Health)
`
`
`
`
`
`
`
`
`
`
`
`Q3 2016
`
`1,270
`
`1,585
`
`4,370
`
`1,803
`
`624
`
`Change
`(CER)
`
`+16.9%
`
`-2.5%
`
`-2.4%(c)
`
`+14.4%
`
`+4.0%
`
`
`
`
`
`
`
`
`
`
`
`9M 2016
`
`3,684
`
`4,687
`
`13,358
`
`3,225
`
`2,109
`
`Change
`(CER)
`
`+19.1%
`
`-3.9%
`
`-4.1%(e)
`
`+11.0%(f)
`
`+10.3%
`
`+1.2%(g)
`+3.0%(d)
`27,063
`9,652
`
`Total Aggregate Company sales
`
`(a) Does not include Emerging Markets sales- see definition page 8; (b) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care; (c) Excluding
`Venezuela: -1.9%; (d) Excluding Venezuela: +3.3%; (e) Excluding Venezuela:-1.4%; (f) Excluding Venezuela: +11.3%; (g) Excluding Venezuela:+2.8%;
`
`Global Franchises
`
`The table below presents sales by global franchise, which facilitates straightforward peer comparisons. Appendix 1
`provides a reconciliation of sales by GBU and franchise.
`
`Net sales by Franchise
`(€ million)
`
`Q3 2016
`
`Change
`(CER)
`
`Developed
`Markets
`
`Change
`(CER)
`
`Emerging
`Markets
`
`Change
`(CER)
`
`+16.9%
`
`+26.5%(a)
`
`Specialty Care
`
`Diabetes and Cardiovascular
`
`Established Products
`
`Consumer Healthcare (CHC)
`
`Generics
`
`Vaccines
`
`Animal Health
`
`1,517
`
`1,929
`
`2,535
`
`791
`
`453
`
`1,803
`
`624
`
`+18.5%
`
`+0.3%(b)
`
`-7.4%(d)
`
`-1.2%(f)
`
`+1.3%(h)
`
`+14.4%
`
`+4.0%
`
`1,270
`
`1,585
`
`1,587
`
`479
`
`257
`
`1,458
`
`468
`
`-2.5%
`
`-12.5%
`
`+1.3%
`
`+2.8%
`
`+16.4%
`
`+1.1%
`
`247
`
`344
`
`948
`
`312
`
`196
`
`345
`
`156
`
`+14.2%(c)
`
`+1.7%(e)
`
`-4.7%(g)
`
`-0.5%(i)
`
`+6.6%
`
`+13.3%
`
`+3.0%(j)
`+5.6%(k)
`Total Aggregate net sales
`9,652
`7,104
`2,548
`+2.1%
`(a) Excluding Venezuela: +25.9%; (b) Excluding Venezuela: +0.4%; (c) Excluding Venezuela: +15.2%; (d) Excluding Venezuela: -6.9%; (e) Excluding Venezuela: +3.4%;
`.(f) Excluding Venezuela: -1.0%; (g) Excluding Venezuela: -4.1%; (h) Excluding Venezuela: +2.2%; (i) Excluding Venezuela:+1.5%; (j) Excluding Venezuela: +3.3%; (k)
`
`Excluding Venezuela: +6.6%.
`(7) See Appendix 8 for definitions of financial indicators.
`
`
`
`2
`
`

`
`The table below presents sales by global franchise for the first nine months of 2016.
`
`
`Net sales by Franchise
`(€ million)
`
`Specialty Care
`
`Diabetes and Cardiovascular
`
`Established Products
`
`Consumer Healthcare (CHC)
`
`Generics
`
`Vaccines
`
`9M 2016
`
`4,381
`
`5,723
`
`7,743
`
`2,496
`
`1,386
`
`3,225
`
`Change
`(CER)
`
`+18.8%(a)
`
`-1.8%
`
`-8.5%(d)
`
`-2.9%(f)
`
`+0.8%(h)
`
`+11.0%(j)
`
`Developed
`Markets
`
`Change
`(CER)
`
`Emerging
`Markets
`
`3,684
`
`4,687
`
`4,930
`
`1,584
`
`810
`
`2,268
`
`+19.1%
`
`-3.9%
`
`-11.6%
`
`+1.7%
`
`+0.9%
`
`+9.2%
`
`+7.4%
`
`697
`
`1,036
`
`2,813
`
`912
`
`576
`
`957
`
`Change
`(CER)
`
`+17.5%(b)
`
`+8.2%(c)
`
`-2.9%(e)
`
`-9.3%(g)
`
`+0.8%(i)
`
`+15.3%(k)
`
`+21.1%
`
`Animal Health
`
`2,109
`
`+10.3%
`
`1,645
`
`464
`
`+3.0%(m)
`+1.2%(l)
`7,455
`19,608
`27,063
`Total Aggregate net sales
`+0.5%
`(a) Excluding Venezuela : +19.3%; (b) Excluding Venezuela : +20.1%; (c) Excluding Venezuela : +12.9%; (d) Excluding Venezuela : -6.1%; (e) Excluding Venezuela :
`+4.4%; (f) Excluding Venezuela: +0.7%; (g) Excluding Venezuela: -0.7%; (h) Excluding Venezuela: +3.0%; (i) Excluding Venezuela: +5.7%; (j) Excluding Venezuela:
`+11.3%;(k) Excluding Venezuela: +16.5%; (l) Excluding Venezuela: +2.8%; (m) Excluding Venezuela: +8.7%.
`
`
`Pharmaceuticals
`
`Third-quarter sales for Pharmaceuticals increased 0.5% to €7,225 million. Growth in the Multiple Sclerosis, Rare Disease
`and Cardiovascular franchises offset a decrease in Diabetes, CHC and Established Rx Products. Year-to-date sales for
`Pharmaceuticals decreased 0.9% to €21,729 million. Excluding Venezuela, year-to-date sales for Pharmaceuticals
`increased 0.9%.
`
`Rare Disease franchise
`
`
`Net sales (€ million)
`
`Q3 2016
`
`Cerezyme®
`Myozyme® / Lumizyme®
`Fabrazyme®
`Aldurazyme®
`Cerdelga®
`
`Total Rare Diseases
`
`183
`185
`176
`53
`28
`
`708
`
`Change
`(CER)
`
`+1.6%
`
`+16.0%
`
`+20.4%
`
`+12.5%
`
`+55.6%
`
`+14.3%
`
`9M 2016
`
`564
`533
`492
`151
`77
`
`2,061
`
`Change
`(CER)
`
`+4.5%
`
`+12.8%
`
`+15.0%
`
`+7.5%
`
`+75.0%
`
`+12.4%
`
`
`In the third quarter, Gaucher (Cerezyme® and Cerdelga®) sales grew 6.3% to €211 million, reflecting Cerezyme® growth
`in Emerging Markets (up 26.9% to €56 million) and the increasing contribution of Cerdelga® (€28 million versus €18
`million in the third quarter of 2015). Year-to-date Gaucher sales increased 9.5% to €641 million.
`
`Third-quarter sales of Fabrazyme® increased 20.4% to €176 million. The strong global momentum of Fabrazyme® is a
`result of continued accrual of new patients as a result of patients switching from competing products and earlier stage
`patient identification and treatment. Year-to-date sales of Fabrazyme® were up 15.0% to €492 million.
`
`Sales of Myozyme®/Lumizyme® increased 16.0% to €185 million in the third quarter, mainly due to new patient accruals
`as a consequence of increased patient identification. Year-to-date sales of Myozyme®/Lumizyme® increased 12.8% to
`€533 million.
`
`Multiple Sclerosis franchise
`
`
`Net sales (€ million)
`
`Q3 2016
`
`Aubagio®
`Lemtrada®
`
`Total Multiple Sclerosis
`
`334
`112
`
`446
`
`Change
`(CER)
`
`+49.8%
`
`+69.1%
`
`+54.3%
`
`9M 2016
`
`928
`308
`
`1,236
`
`Change
`(CER)
`
`+56.8%
`
`+95.1%
`
`+64.9%
`
`
`Third-quarter sales of Aubagio® were up 49.8% to €334 million driven by the U.S. (up 50.9% to €239 million) and
`Europe (up 41.5% to €75 million). Aubagio® is currently the fastest growing oral disease modifying therapy in the Multiple
`Sclerosis market with patient market share of 9.0% in the U.S. (IMS NSP TRX – second week of October). Year-to-date
`sales of Aubagio® increased 56.8% to €928 million.
`
`
`
`3
`
`

`
`
`In the third quarter, sales of Lemtrada® increased 69.1% to €112 million, including €64 million in the U.S. (up 66.7%)
`and €37 million in Europe (up 81.8%), mainly generated in the UK. Year-to-date sales of Lemtrada® were up 95.1% to
`€308 million.
`
`Oncology franchise
`
`
`Net sales (€ million)
`
`Q3 2016
`
`Change
`(CER)
`
`9M 2016
`
`Change
`(CER)
`
`88
`70
`45
`43
`39
`16
`
`363
`
`+12.8%
`
`+12.7%
`
`-22.4%
`
`-24.1%
`
`+8.3%
`
`-10.5%
`
`-2.4%
`
`266
`204
`137
`129
`111
`50
`
`1,084
`
`+12.7%
`
`+11.2%
`
`-18.5%
`
`-19.5%
`
`+7.6%
`
`-13.6%
`
`-1.6%
`
`Jevtana®
`Thymoglobulin®
`Taxotere®
`Eloxatin®
`Mozobil®
`Zaltrap®
`Total Oncology
`
`In the Third quarter, Oncology sales decreased 2.4% to €363 million, reflecting lower sales of Taxotere® and Eloxatin®.
`Year-to-date sales of Oncology were €1,084 million, down 1.6%.
`
`Sales of Jevtana® increased 12.8% to €88 million in the third quarter led by the U.S. (up 21.9% to €38 million) and
`Japan. Year-to-date sales of Jevtana® were up 12.7% to €266 million.
`
`Third-quarter Thymoglobulin® sales increased 12.7% to €70 million supported by sales in China. Year-to-date sales of
`Thymoglobulin® were up 11.2% to €204 million.
`
`Third-quarter sales of Eloxatin® were down 24.1% to €43 million reflecting generic competition in Canada. Over the
`same period, sales of Taxotere® (docetaxel) decreased 22.4% (to €45 million) due to generic competition in Japan.
`Year-to-date sales of Taxotere® and Eloxatin® were down 18.5% (€137 million) and down 19.5% (€129 million),
`respectively.
`
`Diabetes franchise
`
`
`Net sales (€ million)
`
`Q3 2016
`
`
`In the third quarter, Diabetes franchise sales were down 1.5% to €1,805 million, reflecting lower sales of Lantus® in the
`U.S. Third-quarter U.S. Diabetes sales were down 5.4% to €1,013 million. Outside the U.S., sales were €792 million, an
`increase of 3.9% driven by Emerging Markets (up 13.6% to €341 million). Sales in Europe were €325 million, a decrease
`of 0.6%. In Europe, sales of Toujeo® offset lower sales of Lantus®. Year-to-date sales for the Diabetes franchise were
`€5,396 million, down 3.0%.
`
`Third-quarter sales of Sanofi’s glargine (Lantus® and Toujeo®) were €1,558 million, down 1.9%. In the U.S., Sanofi’s
`glargine sales of €980 million were down 5.1%. In Europe, sales of Sanofi’s glargine increased 0.4% to €248 million
`despite the launch of a biosimilar glargine in several European markets. Year-to-date sales of Sanofi’s glargine were
`€4,662 million, down 3.5%.
`
`Over the quarter, sales of Lantus® were €1,391 million down 9.8%. In the U.S., as anticipated, sales of Lantus®
`decreased 13.5% to €858 million mainly reflecting lower average net price and patients switching to Toujeo®. In Europe,
`third-quarter Lantus® sales were €215 million (down 11.0%) while in Emerging Markets, sales were €232 million (up
`13.4%) driven by China and Russia. Year-to-date sales of Lantus® were €4,251 million, down 10.7%.
`4
`
`
`
`Lantus®
`Toujeo®
`
`Total glargine
`Amaryl®
`Apidra®
`Insuman®
`BGM (Blood Glucose Monitoring)
`Lyxumia®
`
`Total Diabetes
`(a) Excluding Venezuela: -2.3%;
`
`1,391
`167
`
`1,558
`92
`94
`32
`16
`9
`
`1,805
`
`Change
`(CER)
`
`-9.8%
`
`265.2%
`
`-1.9%
`
`+1.1%
`
`+6.8%
`
`-8.3%
`
`+6.7%
`
`-11.1%
`
`-1.5%
`
`9M 2016
`
`4,251
`411
`
`4,662
`273
`272
`98
`50
`26
`
`5,396
`
`Change
`(CER)
`
`-10.7%
`
`ns
`
`-3.5%
`
`-4.7%
`
`+2.2%
`
`0.0%
`
`+6.4%
`
`-3.7%
`
`-3.0%(a)
`
`

`
`Third-quarter sales of Toujeo® were €167 million of which €122 million were recorded in the U.S. and €33 million were
`from Europe. The global roll-out of this product continues and Sanofi expects Toujeo® to be available in over 40
`countries by the end of 2016. In Japan, the two-week prescription limit was lifted in September 2016, resulting in a
`significant increase in market share (9.2% the second week of October- IMS Market Share of the Basal insulin market in
`International Units). Year-to-date sales of Toujeo® were €411 million.
`
`Sales of Amaryl® were €92 million, up 1.1% in the third quarter, of which €74 million were generated in Emerging
`Markets (up 6.8%). Year-to-date sales of Amaryl® were €273 million, down 4.7%.
`
`Third-quarter sales of Apidra® were up 6.8% to €94 million, reflecting lower sales in the U.S. (down 8.8% to €31 million),
`which were more than offset by the performance in Emerging Markets (up 33.3% to €19 million) and Europe (up 10.0%
`to €32 million). Year-to-date sales of Apidra® increased 2.2% to €272 million.
`
`Sanofi has recently been informed by U.S. payers of the 2017 formulary status for its products. Despite the anticipated
`introduction of biosimilar glargine, Lantus® and Toujeo® remain competitively positioned on the vast majority of
`formularies in the U.S. Given the recent performance of our diabetes franchise in the EU and Emerging Markets, as well
`as the aforementioned coverage in the U.S., Sanofi continues to expect global diabetes sales over the period from 2015
`to 2018 to decline at an average annualized rate of between 4% and 8% at CER.
`
`
`Cardiovascular franchise
`Praluent® (alirocumab, collaboration with Regeneron) was launched in the U.S. and in a number of European markets in
`2015 and 2016. Third-quarter sales of Praluent® were €35 million of which €28 million were in the U.S. and €6 million in
`Europe. Praluent® was launched in Japan in July. Year-to-date sales of Praluent® were €68 million reflecting significant
`payer utilization management restrictions in the U.S. and limited market access in Europe.
`
`Third-quarter sales and first nine-month sales of Multaq® were €89 million (up 3.5%) and €259 million (up 1.6%),
`respectively. In August 2016, the District Court of Delaware ruled in favor of Sanofi in the Multaq® patent litigation holding
`that the defendants infringe both of the patents at suit; the ‘800 Formulation patent and the 167 Method of Use patent,
`expiring in 2018 and 2029, respectively. Both defendants appealed that ruling in September.
`
`Established Rx Products
`
`
`Net sales (€ million)
`
`Q3 2016
`
`Change
`(CER)
`
`9M 2016
`
`Change
`(CER)
`
`-9.9%
`
`-4.0%
`
`+2.9%
`
`+7.2%
`
`+4.2%
`
`+1.4%
`
`-18.2%
`
`-12.7%
`
`1,181
`1,222
`687
`518
`297
`225
`145
`3,468
`
`-18.5%(b)
`
`-2.5%(c)
`
`-0.6%
`
`-8.4%(d)
`
`+1.3%
`
`+0.5%
`
`-10.0%
`
`-9.3%(e)
`
`Plavix®
`Lovenox®
`Renvela®/Renagel®
`Aprovel®/Avapro®
`Synvisc® /Synvisc-One®
`Myslee®/Ambien®/Stilnox®
`Allegra®
`Other
`Total Established Rx Products
`-7.4%(a)
`-8.5%(f)
`2,535
`7,743
`(a) Excluding Venezuela: -6.9%; (b) Excluding Venezuela: -16.3%; (c) Excluding Venezuela: -1.7%; (d) Excluding Venezuela: -0.4%; (e) Excluding Venezuela: -6.5%; (f)
`
`Third-quarter sales of Established Rx Products decreased 7.4% to €2,535 million, reflecting generic competition to
`Plavix® in Japan, the impact of the termination of Auvi-Q® commercialization in the U.S. and lower sales in Venezuela.
`Excluding Venezuela and Auvi-Q®, sales of Established Rx Products were down 4.8%. In Emerging Markets, sales of
`Established Rx Products were €948 million, up 1.7% (up 3.4% excluding Venezuela). In the U.S., sales of Established
`Rx Products were down 13.2% (to €375 million). Excluding Auvi-Q®, sales of Established Rx Products were down 0.5%
`in the U.S. In Europe, sales of Established Rx Products decreased 7.6% to €856 million. Year-to-date sales of
`Established Rx Products decreased 8.5% to €7,743 million and 6.1% excluding Venezuela.
`
`In the third quarter, sales of Lovenox® decreased 4.0% to €404 million reflecting generic competition in the U.S. (down
`25.0% to € 12 million) and lower sales in Europe (down 2.3% to €248 million) and in Emerging Markets (down 3.1% to
`€120 million). In September, two enoxaparin biosimilars were approved in the European Union. Year-to-date sales of
`Lovenox® were €1,222 million down 2.5%.
`
`Third-quarter sales of Plavix® decreased 9.9% to €401 million due to generic competition in Japan that started in June
`2015 (sales in Japan were down 48.3% to €88 million), which was partially offset by the growth in China (up 18.1% to
`€190 million). Year-to-date sales of Plavix® decreased 18.5% to €1,181 million (16.3% excluding Venezuela).
`
`401
`404
`245
`174
`100
`77
`31
`1,103
`
`Excluding Venezuela: -6.1%;
`
`
`
`5
`
`

`
`Sales of Renvela®/Renagel® were up 2.9% to €245 million in the third quarter driven by the U.S. (€206 million, up 8.4%).
`In Europe, sales of Renvela®/Renagel® were down 27.6% to €20 million due to generics competition. Sanofi now expects
`generic competition in the U.S. in the first half of 2017. Year-to-date sales of Renvela®/Renagel® decreased 0.6% to
`€687 million.
`
`Sales of Aprovel®/Avapro® increased 7.2% to €174 million in the third quarter. Year-to-date sales of Aprovel®/Avapro®
`decreased 8.4% to €518 million (stable excluding Venezuela).
`
`In the third quarter and the first nine months of 2015, sales of Auvi-Q® and Allerject® were €61 million and €113 million,
`respectively. Sanofi no longer commercializes this product and no sales were recorded in 2016.
`
`Consumer Healthcare
`
`
`Net sales (€ million)
`
`Allegra®
`Doliprane®
`Enterogermina®
`Essentiale®
`Nasacort®
`Lactacyd®
`Maalox®
`No Spa®
`Magne B6®
`Dorflex®
`Other CHC Products
`
`Q3 2016
`
`94
`69
`38
`29
`23
`20
`18
`22
`19
`21
`438
`
`Change
`(CER)
`
`+3.3%
`
`+7.7%
`
`+18.2%
`
`-30.4%
`
`-14.8%
`
`-23.1%
`
`-9.5%
`
`4.5%
`
`-9.5%
`
`-4.8%
`
`+0.9%
`
`9M 2016
`
`331
`223
`123
`100
`91
`61
`63
`62
`55
`55
`1,332
`
`Change
`(CER)
`
`-2.9%
`
`+2.3%
`
`+2.4%
`
`-22.0%
`
`-8.9%
`
`-29.8%
`
`-10.7%
`
`+3.0%
`
`-6.5%
`
`-3.1%
`
`+0.3%
`
`2,496
`
`-2.9%(b)
`
`Total Consumer Healthcare
`(a) Excluding Venezuela: -1.0%; (b) Excluding Venezuela: +0.7%;
`
`In the third-quarter, Consumer Healthcare (CHC) sales were €791 million, down 1.2%. Excluding Venezuela and the
`divestiture of smaller products, CHC sales decreased 0.1% impacted by Russia. Third-quarter sales of CHC in the U.S.
`increased 3.3% to €216 million. This was driven by a solid performance across the portfolio partially offset by Allegra®
`(up 1.9% to €54 million) and Nasacort® (down 20.8% to €19 million), which were both impacted by a mild U.S. allergy
`season. In addition, Nasacort® is facing an increasingly competitive environment.
`
`In Emerging Markets, sales were down 4.7% to €312 million (down 4.1% excluding Venezuela) reflecting lower sales in
`Russia. In Russia, sales were significantly impacted by the challenging local economic situation. In the quarter, sales in
`Europe decreased 1.5% to €195 million reflecting the divestitures of small products and the solid performance of
`Doliprane® (up 9.4% to €58 million). Year-to-date sales of CHC reached €2,496 million, down 2.9% (up 2.3% excluding
`Venezuela and the divestiture of several small products).
`
`Sanofi continues to expect the exchange of Sanofi’s animal health business with Boehringer Ingelheim’s consumer
`healthcare business (initiated in December 2015 and signed in June 2016) to close around year-end 2016, subject to
`approval by regulatory authorities in different territories.
`
`Generics
`
`Third-quarter sales of Generics increased 1.3% to €453 million (up 2.2% excluding Venezuela) driven by the U.S. (up
`8.3% to €38 million) and Europe (up 2.0% to €197 million), which more than offset the slight decrease in Emerging
`Markets (down 0.5% to €196 million). Year-to-date sales of Generics were up 0.8% to €1,386 million (up 3.0% excluding
`Venezuela).
`
`As announced in our 2020 strategic roadmap, Sanofi has carefully reviewed all options and has decided to initiate a
`carve-out process in order to divest its Generics business in Europe. Sanofi will be looking for a potential acquirer that
`will leverage the mid and long-term sustainable growth opportunities for this business. Sanofi confirms its commitment to
`its Generics business in other parts of the world and will further focus on the Emerging Markets in order to develop its
`business in those countries.
`
`
`791
`
`-1.2%(a)
`
`
`
`6
`
`

`
`Vaccines
`
`Net sales (€ million)
`
`Polio/Pertussis/Hib vaccines
`(incl. Pentacel®, Pentaxim® and Imovax®)
`Meningitis/Pneumonia vaccines
`(incl. Menactra®)
`Adult Booster vaccines (incl. Adacel ®)
`Influenza vaccines
`(incl. Vaxigrip® and Fluzone®)
`Travel and other endemic vaccines
`Dengvaxia®
`Other vaccines
`Total Vaccines (consolidated sales)
`
`Q3 2016
`
`324
`
`254
`104
`989
`77
`30
`25
`1,803
`
`Change
`(CER)
`
`-0.3%
`
`-1.5%
`
`-21.1%
`
`+34.6%
`
`-18.8%
`-
`-24.1%
`
`+14.4%
`
`9M 2016
`
`951
`
`515
`288
`1,105
`261
`50
`55
`3,225
`
`Change
`(CER)
`
`+10.7%
`
`+4.2%
`
`-15.6%
`
`+28.0%
`
`-2.5%
`
`-30.8%
`
`+11.0%*(a)
`
`*Comparability based on the new presentation of VaxServe sales (see below)
` (a) Excluding Venezuela: +11.3%;
`
`VaxServe sales
`VaxServe is a U.S. entity of the Vaccines segment. VaxServe activities include products distribution in the U.S. in
`channels that are not the primary focus of Sanofi Pasteur. VaxServe complements its Sanofi Pasteur products offering
`by distributing vaccines and other products from third party manufacturers. All VaxServe sales were reported on the line
`Net sales in the past.
`In order to provide more relevant published information, VaxServe sales of non-Sanofi products are reported in the line
`Other revenues in the income statement from January 1, 2016. Accordingly, prior period comparative net sales have
`been reclassified to the line Other revenues.
`The 2015 quarterly and full-year 2015 business P&L as well as sales of GBUs and franchises by geographic region
`reflecting this reclassification are available on the Investors section of Sanofi’s website.
`In the third quarter of 2015 and in full-year 2015, sales of VaxServe(8) of non-Sanofi products were €136 million and €482
`million, respectively.
`
`Vaccines
`
`In the third quarter, consolidated Vaccines sales increased 14.4% to €1,803 million driven by the U.S (up 19.1% to
`€1,261 million) supported by the flu vaccines franchise. In Emerging Markets sales of vaccines increased 6.6% driven by
`the solid performance of our AcXim family (excluding China) and the launch of Dengvaxia® partially offset by a local
`market disruption in China. Year-to-date sales of Sanofi Pasteur were up 11.0% to €3,225 million.
`
`Third quarter sales of Polio/Pertussis/Hib Vaccines were down slightly (0.3%) to €324 million. In Emerging Markets,
`sales of the franchise decreased 2.2% to €170 million impacted by the local market disruption in China resulting in lower
`sales of Pentaxim® and Polio vaccines and offsetting the growth of Pentaxim® and Hexaxim® in other regions. In the U.S.,
`sales of Polio/Pertussis/Hib Vaccines decreased 8.0% to €91 million reflecting lower sales of Pentacel® (down 18.9% to
`€61 million). As previously communicated, Sanofi Pasteur is experiencing Pentacel® manufacturing delays and supply is
`expected to improve by late fourth quarter 2016. Year-to-date sales of Polio/Pertussis/Hib vaccines were up 10.7% to
`€951 million.
`
`Dengvaxia®, the world's first dengue vaccine is now approved in 13 countries (Bolivia, Brazil, Cambodia, Costa Rica, El
`Salvador, Guatemala, Indonesia, Mexico, Paraguay, Peru, the Philippines, Thailand, and Singapore). In the third quarter
`of 2016, sales of Dengvaxia® were €30 million reflecting the second shipment for the public dengue immunization
`program in the Philippines, the first dose of the public vaccination program in Paraná State in Brazil, as well as sales on
`the private market. Year-to-date sales of Dengvaxia® were €50 million.
`
`Sales of Influenza vaccines increased 34.6% to €989 million in the third quarter, driven by the U.S. (up 45.0% to €834
`million) reflecting favorable phasing as well as Sanofi Pasteur’s strategy to offer differentiated influenza vaccines. Year-
`to-date sales of Influenza vaccines were up 28.0% to €1,105 million.
`
`Third-quarter Menactra® sales were up 1.7% to €242 million, of which €219 million was generated in the U.S (down
`1.3%). Year-to-date sales of Menactra® increased 5.7% to €479 million.
`
`Adult Booster vaccines sales decreased 21.1% to €104 million in the third quarter, impacted by increased competitive
`pressure in the U.S. towards Adacel® and a contraction of the U.S. Tdap (Tetanus, Diphtheria, acellular Pertussis)
`market. Year-to-date sales of Adult Booster vaccines decreased 15.6% to €288 million.
`(8) Sales of VaxServe in Q3 2016 and in the first nine month of 2016 are provided in the Financial Results
`
`
`
`7
`
`

`
`Third-quarter sales of Travel and other endemic vaccines were €77 million, down 18.8% due to a supply constraint for
`rabies and hepatitis A vaccines. Year-to-date sales of Travel and other endemic vaccines decreased 2.5% to €261
`million.
`
`Sales of Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe, increased 5.2% (on a
`reported basis) to €299 million driven by Hexyon® (pediatric hexavalent vaccine) and Gardasil®. Year-to-date sales of
`Sanofi Pasteur MSD were up 9.4% (on a reported basis) to €639 million. In March, Sanofi Pasteur and Merck announced
`their intent to end their joint vaccines operations in Europe, Sanofi Pasteur MSD, to pursue their own distinct growth
`strategies in Europe. Sanofi Pasteur and Merck expect the separation to be completed by the end of 2016, subject to
`local labor laws and regulations as well as regulatory approvals.
`
`Animal Health(9)
`
`
`
`Net sales (€ million)
`
`Companion Animal
`
`Production Animal
`
`Total Animal Health
`
` of which vaccines
`
` of which fipronil products
`
` of which avermectin products
`
`Q3 2016
`
`400
`224
`
`624
`202
`112
`111
`
`Change
`(CER)
`
`+0.7%
`
`+10.2%
`
`+4.0%
`
`+3.0%
`
`-17.4%
`
`-4.3%
`
`9M 2016
`
`1,422
`687
`
`2,109
`619
`462
`423
`
`Change
`(CER)
`
`+10.1%
`
`+10.8%
`
`+10.3%
`
`+8.5%
`
`-10.1%
`
`+6.2%
`
`
`In the third quarter, Animal Health sales increased 4.0% to €624 million driven by strong performance of Ruminant
`business in the U.S. and NexGard®. Year-to-date sales of Animal Health were up 10.3% to €2,109 million.
`
`Third-quarter sales of the Companion Animals segment were up 0.7% to €400 million reflecting the strong performance
`of NexGard® (Merial’s next generation flea and tick products for dogs in the U.S.) and NexGard® Spectra as well as
`lower sales of the Frontline® family of products and HeartGard® mostly linked to phasing of promotional activities. Year-
`to-date sales of the Companion Animals segment were up 10.1% to €1,422 million.
`
`Sales of the Production Animals segment were up 10.2% to €224 million in the third quarter due to strong performance
`of Ruminant business in the U.S. Year-to-date sales of the Production Animals segment were up 10.8% to €687 million.
`
`Aggregate Company sales by geographic region
`
`
`Aggregate Sanofi sales (€ million)
`
`Q3 2016
`
`United States
`
`Emerging Markets(a)
`
` of which Latin America
`
` of which Asia
` of which Africa, Middle East and South Asia(b)
` of which Eurasia(c)
`Europe(d)
`
`Rest of the World(e)
`
` of which Japan
`
`4,001
`
`2,548
`
`714
`
`853
`
`699
`
`251
`
`2,264
`
`839
`
`421
`
`Change
`(CER)
`
`+7.0%
`
`+5.6%
`
`+8.5%
`
`+4.0%
`
`+8.1%
`
`-1.1%
`
`-0.5%
`
`-12.2%
`
`-21.4%
`
`9M 2016
`
`10,085
`
`7,455
`
`1,983
`
`2,490
`
`2,103
`
`780
`
`6,996
`
`2,527
`
`1,314
`
`Change
`(CER)
`
`+3.5%
`
`+3.0%
`
`-8.5%
`
`+8.0%
`
`+10.0%
`
`+4.4%
`
`+1.5%
`
`-12.6%
`
`-23.9%
`
`27,063
`9,652
`Total Aggregate Sanofi sales
`+3.0%
`(a) World 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
`Japan, South Korea, Canada, Australia, New Zealand, Puerto Rico
`(e)
`
`Third-quarter Aggregate sales in the U.S. grew 7.0% to €4,001 million driven mainly by double digit growth of the multiple
`sclerosis franchise (up 54.0%), rare disease franchise (up 10.7%) and Vaccines (up 19.1%). The U.S. sales performance
`also included lower sales of the diabetes franc