Sanofi: Q2 2018 Performance Positions Sanofi for New Growth Phase
Paris, July 31, 2018
Q2 2018 Performance Positions Sanofi for New Growth Phase
Q2 2018 | Change | Change at CER | H1 2018 | Change | Change at CER | |
IFRS net sales reported | €8,176m | -5.7% | +0.1% | €16,074m | -7.2% | -0.1% |
IFRS net income reported | €762m | -26.2% | - | €1,778m | -73.6%(2) | - |
IFRS EPS reported | €0.61 | -25.6% | - | €1.42 | -73,4%(2) | - |
Business net income(1) | €1,558m | -7.9% | +0.4% | €3,156m | -9.4% | +0.4% |
Business EPS(1) | €1.25 | -6.7% | +1.5% | €2.53 | -8.3% | +1.4% |
Second-quarter 2018 sales stable(3) with strong contributions from Specialty Care and Emerging Markets Net sales were €8,176 million, down 5.7% on a reported basis, up 0.1%(3) at CER and down 2.5% at CER/CS (4). Sanofi Genzyme sales up 14.1% at CER/CS (4) (33.1% at CER) driven by Dupixent® and consolidation of Bioverativ. Vaccines sales down 15.7% reflecting high basis for comparison and expected Pentaxim® supply constraint in China. CHC sales increased 4.1% supported by growth in Europe and Emerging Markets(5). DCV(6) GBU sales down 15.6%; global Diabetes franchise sales declined 11.9%, confirming expected trend for year. Emerging Markets sales(5) increased 5.2% with double-digit growth in China. 2018 business EPS guidance range slightly narrowed Second-quarter 2018 business EPS(1) up 1.5% at CER to €1.25. Second-quarter 2018 IFRS EPS was €0.61 (-25.6%). Business EPS(1) in 2018 now expected to grow 3% to 5% at CER(7) barring unforeseen major adverse events. Currency impact on 2018 business EPS is estimated to be around -6% applying the average July exchange rates. Key achievements in sustaining innovation in R&D Sanofi completed the acquisition of Ablynx in May, internalizing the innovative Nanobody® platform. Positive CHMP recommendation for CabliviTM for aTTP(8). Phase 1/2a data on BIVV001, an extended factor VIII therapy, demonstrated half-life of 37 hours. A phase 2/3 study is being initiated on venglustat, an oral glucosylceramide synthase (GCS) inhibitor, in ADPKD(9). Positive phase 3 trial evaluating Dupixent® to treat moderate-to-severe atopic dermatitis in adolescents. Priority review granted in the U.S. to cemiplimab for the treatment of CSCC(10). ZynquistaTM (sotagliflozin) accepted for review by the FDA in type 1 diabetes. Praluent® ODYSSEY OUTCOMES results submitted to the FDA and EMA in Q2. |
Sanofi Chief Executive Officer, Olivier Brandicourt, commented: "In the second quarter, we achieved significant milestones in building our new Rare Blood Disorder franchise and the successful continued execution of the global roll-out of Dupixent®. As the impact from the U.S. losses of exclusivity peaked in the second quarter, the growth of our diversified businesses largely compensated for these headwinds. We look forward to entering a new growth phase led by our increasing focus on Specialty Care and our leadership positions in Emerging Markets and Vaccines." |
(1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (see Appendix 8 for definitions). The consolidated income statement for Q2 2018 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) Excluding Animal Health gain on disposal, first-half IFRS net income was down 22.6% and first-half IFRS EPS was down 22.4%;(3) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 10); (4) Constant Structure: Adjusted for Bioverativ acquisition; (5) See definition page 8; (6) DCV: Diabetes and Cardiovascular; (7) 2017 business EPS was €5.52; (8) Acquired thrombotic thrombocytopenic purpura; (9) Autosomal Dominant Polycystic Kidney Disease; (10) Cutaneous Squamous Cell Carcinoma
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2018 Second-quarter and first-half Sanofi sales
Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(11). |
In the second quarter of 2018, Company sales were €8,176 million, down 5.7% on a reported basis. Exchange rate movements had a negative effect of 5.8 percentage points mainly driven by the movement of the U.S. Dollar accompanied by the Brazilian Real, Argentine Peso, Turkish Lira, Japanese Yen and Russian Ruble. At CER, Company sales increased 0.1%.
First-half Company sales reached €16,074 million, down 7.2% on a reported basis. Exchange rate movements had an unfavorable effect of 7.1 percentage points. At CER, Company sales were down 0.1%.
Global Business Units
The table below presents sales by Global Business Unit (GBU). Please note that Emerging Markets sales for Specialty Care and Diabetes and Cardiovascular are included in the General Medicines and Emerging Markets GBU.
Net Sales by GBU (€ million) | Q2 2018 | Change at CER | H1 2018 | Change at CER | ||
Sanofi Genzyme (Specialty Care)(a) | 1,808 | +33.1% | 3,268 | +24.8% | ||
Diabetes and Cardiovascular(a) | 1,107 | -15.6% | 2,195 | -15.6% | ||
General Medicines & Emerging Markets(b) | 3,335 | -3.7% | 6,736 | -2.6% | ||
Total Pharmaceuticals | 6,250 | +1.9% | 12,199 | +0.5% | ||
Consumer Healthcare (CHC) | 1,115 | +4.1% | 2,353 | +3.0% | ||
Sanofi Pasteur (Vaccines) | 811 | -15.7% | 1,522 | -9.3% | ||
Total net sales | 8,176 | +0.1% | 16,074 | -0.1% |
(a) Does not include Emerging Markets sales- see definition page 8; (b) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care
Global Franchises
The tables below present second-quarter and first-half 2018 sales by global franchise, including Emerging Markets sales, to facilitate comparisons. Appendix 1 provides a reconciliation of sales by GBU and franchise.
Net sales by Franchise (€ million) | Q2 2018 | Change at CER | Developed Markets | Change at CER | Emerging Markets | Change at CER |
Specialty Care | 2,071 | +29.5% | 1,808 | +33.1% | 263 | +10.3% |
Diabetes and Cardiovascular | 1,511 | -9.4% | 1,107 | -15.6% | 404 | +12.2% |
Established Rx Products | 2,266 | -7.9% | 1,301 | -17.3% | 965 | +7.8% |
Consumer Healthcare (CHC) | 1,115 | +4.1% | 723 | +0.8% | 392 | +10.1% |
Generics | 402 | -1.6% | 230 | -6.8% | 172 | +5.3% |
Vaccines | 811 | -15.7% | 482 | -15.9% | 329 | -15.5% |
Total net sales | 8,176 | +0.1% | 5,651 | -2.1% | 2,525 | +5.2% |
Net sales by Franchise (€ million) | H1 2018 | Change at CER | Developed Markets | Change at CER | Emerging Markets | Change at CER |
Specialty Care | 3,781 | +23.1% | 3,268 | +24.8% | 513 | +13.4% |
Diabetes and Cardiovascular | 2,995 | -9.0% | 2,195 | -15.6% | 800 | +15.0% |
Established Rx Products | 4,586 | -7.1% | 2,628 | -16.7% | 1,958 | +8.7% |
Consumer Healthcare (CHC) | 2,353 | +3.0% | 1,552 | -1.6% | 801 | +12.3% |
Generics | 837 | -0.3% | 486 | -3.7% | 351 | +4.1% |
Vaccines | 1,522 | -9.3% | 953 | -4.2% | 569 | -16.7% |
Total net sales | 16,074 | -0.1% | 11,082 | -3.1% | 4,992 | +6.8% |
(11) See Appendix 10 for definitions of financial indicators.
Pharmaceuticals
Second-quarter Pharmaceutical sales were up 1.9% to €6,250 million driven by the Rare Blood Disorder and Immunology franchises which were partially offset by Diabetes and Established Rx Products. First-half sales for Pharmaceuticals increased 0.5% to €12,199 million.
Rare Disease franchise
Net sales (€ million) | Q2 2018 | Change at CER | H1 2018 | Change at CER |
Myozyme® / Lumizyme® | 209 | +7.8% | 405 | +9.4% |
Fabrazyme® | 188 | +6.3% | 358 | +6.5% |
Cerezyme® | 181 | +2.6% | 356 | +6.2% |
Aldurazyme® | 52 | -1.8% | 103 | +1.8% |
Cerdelga® | 38 | +32.3% | 74 | +29.0% |
Others Rare Disease | 75 | +5.3% | 142 | -5.5% |
Total Rare Disease | 743 | +6.1% | 1,438 | +6.5% |
In the second quarter, Rare Disease sales increased 6.1% to €743 million, driven by Europe (up 6.2% to €256 million), Emerging Markets (up 7.1% to €139 million) and Rest of the World (up 12.0% to €85 million). In the U.S., second-quarter Rare Disease sales grew 3.7% to €263 million. First-half Rare Disease sales increased 6.5% to €1,438 million.
Second-quarter Gaucher (Cerezyme® and Cerdelga®) sales were up 6.7% to €219 million, supported by the increasing penetration of Cerdelga® in Europe and the U.S. and the sustained growth of Cerezyme® in Emerging Markets. Second-quarter Cerdelga® sales increased 32.3% to €38 million, with sales doubling in Europe (€12 million). First-half Gaucher sales were €430 million, up 9.5%.
Second-quarter Myozyme®/Lumizyme® sales grew 7.8% to €209 million, supported by positive trends in naïve patient accruals. Second-quarter Myozyme®/Lumizyme® sales increased 9.2% to €95 million in Europe and 8.8% to €69 million in the U.S., respectively. First-half Myozyme®/Lumizyme® sales increased 9.4% to €405 million.
Second-quarter Fabrazyme® sales grew 6.3% to €188 million. Second-quarter sales in the U.S. and Europe increased 5.2% (to €93 million) and 9.8% (to €45 million), respectively. First-half Fabrazyme® sales were up 6.5% to €358 million.
Multiple Sclerosis franchise
Net sales (€ million) | Q2 2018 | Change at CER | H1 2018 | Change at CER |
Aubagio® | 404 | +1.2% | 775 | +6.0% |
Lemtrada® | 102 | -12.9% | 207 | -10.8% |
Total Multiple Sclerosis | 506 | -2.0% | 982 | +2.0% |
Second-quarter Multiple Sclerosis (MS) sales decreased 2.0% to €506 million, reflecting lower Lemtrada® sales and a high basis of comparison for Aubagio® in Europe. First-half MS sales increased 2.0% to €982 million.
Second-quarter Aubagio® sales increased 1.2% to €404 million, supported by the U.S. performance (up 9.1% to €287 million) which was offset by lower sales in Europe (down 21.1% to €89 million) reflecting the high basis of comparison from clinical trial supply orders of approximately €30 million in the second quarter of 2017. First-half Aubagio® sales increased 6.0% to €775 million.
In the second quarter, Lemtrada® sales decreased 12.9% to €102 million due to lower U.S. sales (down 20.6% to €46 million) reflecting increased competition as well as its unique dosing and durable effect. In Europe, Lemtrada® sales were down 2.1% to €45 million. First-half Lemtrada® sales decreased 10.8% to €207 million.
Immunology franchise
Net sales (€ million) | Q2 2018 | Change at CER | H1 2018 | Change at CER |
Dupixent® | 176 | - | 283 | - |
Kevzara® | 20 | - | 30 | - |
Total Immunology | 196 | - | 313 | - |
Dupixent® (collaboration with Regeneron) for the treatment of moderate-to-severe atopic dermatitis in adults generated sales of €176 million in the second quarter compared to €26 million in the second quarter of 2017. In the U.S., Dupixent® was launched in April 2017 and reached sales of €151 million in the second quarter. Demand for the product remains strong with more than 50,000 patients having been prescribed to date and total prescriptions (source: IQVIA weekly TRx data) increasing 27% sequentially in the second quarter. Trade inventory at the end of the second quarter is estimated to have been in the middle of the normal range of three to five weeks. Outside the U.S., Dupixent® was launched in Germany in December 2017 and the Netherlands, Canada, Denmark, Sweden and Japan during the first half of 2018. Second-quarter sales in Europe were €16 million. First-half Dupixent® sales were €283 million compared to €26 million in the first half of 2017.
Kevzara® (collaboration with Regeneron) for rheumatoid arthritis was launched in the U.S. in June 2017, in Germany, the UK, the Netherlands during the second half of last year and in Japan, Belgium, Sweden and Finland in the first half of 2018. Second-quarter Kevzara® sales were €20 million, of which €15 million were generated in the U.S. reflecting improved U.S. commercial coverage. First-half Kevzara® sales were €30 million.
Rare Blood Disorder franchise
Net sales (€ million) | Q2 2018 | Change at CER | H1 2018 | Change at CER |
Eloctate® | 176 | - | 219 | - |
Alprolix® | 81 | - | 102 | - |
Total Rare Blood Disorder | 257 | - | 321 | - |
Bioverativ was consolidated in Sanofi's Financial Statements from March 9, 2018. Second-quarter sales of the Rare Blood Disorder franchise were €257 million, up 15.5% on a pro forma basis(12) including non U.S. sales of €38 million with Japan as the primary contributor. Eloctate® and Alprolix® were launched in Colombia in the first quarter of 2018. In the first half of 2018, consolidated sales of the Rare Blood Disorder franchise were €321 million, up 18.3% on a pro forma basis(12).
Eloctate®, a recombinant antihemophilic Factor VIII, Fc Fusion Protein, indicated for the treatment of hemophilia A, generated sales of €176 million in the second quarter, up 20.0% on a pro forma basis(12). First-half consolidated Eloctate® sales were €219 million, up 23.3% on a pro forma basis(12).
Alprolix®, a recombinant coagulation Factor IX, Fc Fusion Protein, indicated for the treatment of hemophilia B, generated sales of €81 million in the second quarter, up 6.6% on a pro forma basis(12) despite a delay in government contracting in Canada. First-half consolidated Alprolix® sales were €102 million, up 8.9% on a pro forma basis(12).
Oncology franchise
Net sales (€ million) | Q2 2018 | Change at CER | H1 2018 | Change at CER |
Jevtana® | 103 | +10.0% | 202 | +10.2% |
Thymoglobulin® | 74 | +3.9% | 144 | +6.1% |
Eloxatin® | 46 | +4.4% | 90 | +5.6% |
Mozobil® | 44 | +15.0% | 82 | +10.0% |
Taxotere® | 41 | 0.0% | 84 | -1.1% |
Zaltrap® | 24 | +38.9% | 46 | +41.2% |
Others | 37 | -31.7% | 79 | -44.5% |
Total Oncology | 369 | +2.4% | 727 | -1.8% |
(12) Growth comparing full second-quarter 2018 sales versus full second-quarter 2017 sales, and full first-half 2018 sales versus full first-half 2017 sales at CER. Unaudited data.
Second-quarter Oncology sales increased 2.4% to €369 million. Consistent with the Company's portfolio prioritization efforts, Sanofi sold Leukine® on January 31, 2018. Excluding Leukine®, oncology second-quarter sales were up 5.1%. First-half Oncology sales were down 1.8% to €727 million and up 4.3% excluding Leukine®.
Jevtana® sales were up 10.0% to €103 million in the second quarter supported by the performance in the U.S. (up 14.6% to €43 million). First-half Jevtana® sales increased 10.2% to €202 million. In the second quarter, Thymoglobulin® and Eloxatin® sales increased 3.9% (to €74 million) and 4.4% (to €46 million), respectively, with growth driven by China. First-half sales of Thymoglobulin® and Eloxatin® increased 6.1% (to €144 million) and 5.6% (to €90 million), respectively.
Diabetes franchise
Net sales (€ million) | Q2 2018 | Change at CER | H1 2018 | Change at CER |
Lantus® | 891 | -20.6% | 1,802 | -19.1% |
Toujeo® | 217 | +7.9% | 414 | +10.7% |
Total glargine | 1,108 | -16.2% | 2,216 | -14.9% |
Apidra® | 92 | +5.4% | 183 | +3.1% |
Amaryl® | 87 | +9.5% | 170 | +5.8% |
Insuman® | 23 | -17.2% | 47 | -12.5% |
Lyxumia® | 6 | -14.3% | 11 | -14.3% |
Soliqua® | 17 | +260.0% | 26 | +222.2% |
Total Diabetes | 1,366 | -11.9% | 2,722 | -10.9% |
In the second quarter, global Diabetes sales decreased 11.9% to €1,366 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S. Second-quarter U.S. Diabetes sales were down 30.1% to €525 million, reflecting the previously announced changes in coverage of the Part D business and a continued decline in average U.S. glargine net prices. Second-quarter sales in Emerging Markets increased 11.8% to €401 million. Second-quarter sales in Europe increased 0.3% to €325 million, supported by Toujeo® growth. First-half global Diabetes sales decreased 10.9% to €2,722 million.
Second-quarter glargine (Lantus® and Toujeo®) sales decreased 16.2% to €1,108 million. U.S. glargine sales were down 32.2% to €489 million, reflecting the aforementioned changes in coverage in Part D and a continued decline in average U.S. glargine net prices. In Europe, glargine sales increased 0.8% to €249 million due to strong Toujeo® performance, despite biosimilar glargine competition in several European markets. First-half glargine sales decreased 14.9% to €2,216 million.
In the second quarter, Lantus® sales were €891 million, down 20.6%. In the U.S., Lantus® sales decreased 33.9% to €403 million mainly reflecting lower average net price and changes in coverage in Part D. In Europe, second-quarter Lantus® sales were €174 million, down 9.8% due to biosimilar glargine competition and patients switching to Toujeo®. In Emerging Markets, second-quarter Lantus® sales were up 1.1% to €244 million. First-half Lantus® sales decreased 19.1% to €1,802 million.
Second-quarter Toujeo® sales were €217 million, up 7.9%. In the U.S., second-quarter Toujeo® sales were €86 million, down 23.0%. In Europe and Emerging Markets, second-quarter Toujeo® sales were €75 million (up 38.9%) and €37 million (versus €24 million), respectively. First-half Toujeo® sales increased 10.7% to €414 million.
Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) was launched in the U.S. in January 2017 and Suliqua(TM) was also launched in several European countries in 2017. Second-quarter and first-half Soliqua® 100/33 / Suliqua(TM) sales were €17 million and €26 million, respectively.
Amaryl® sales were €87 million, up 9.5% in the second quarter, of which €74 million were generated in Emerging Markets (up 11.4%). First-half Amaryl® sales were up 5.8% at €170 million,
Second-quarter Apidra® sales increased 5.4% to €92 million. Lower sales in the U.S. (down 22.2% to €19 million) were offset by strong growth in Emerging Markets (up 29.2% to €27 million). First-half Apidra® sales increased 3.1% to €183 million.
Cardiovascular franchise
Second-quarter Praluent® (collaboration with Regeneron) sales increased 54.8% to €62 million, of which €35 million was generated in the U.S. and €22 million in Europe. First-half Praluent® sales increased 55.3% to €111 million. The Company is in active discussions with a number of U.S. payers to simplify utilization management (UM) criteria and improve access for patients in return for greater rebates, consistent with the new commercial policy for Praluent® announced in March. As a result of recent payer agreements, around 30% of Commercial lives now benefit from improved UM criteria. Negotiations with U.S. payers are ongoing with additional contract decisions expected to be finalized in the next few months.
Second-quarter and first-half Multaq® sales were up 7.2% (to €83 million) and down 1.7% (to €162 million), respectively.
Established Rx Products
Net sales (€ million) | Q2 2018 | Change at CER | H1 2018 | Change at CER |
Lovenox® | 377 | -2.2% | 768 | -1.5% |
Plavix® | 374 | +0.3% | 761 | +4.6% |
Aprovel®/Avapro® | 171 | -6.3% | 343 | -4.7% |
Renvela®/Renagel® | 100 | -57.3% | 201 | -55.7% |
Synvisc® /Synvisc-One® | 92 | -13.8% | 160 | -14.6% |
Myslee®/Ambien®/Stilnox® | 55 | -7.8% | 116 | -8.0% |
Allegra® | 28 | -11.8% | 80 | -14.7% |
Other | 1,069 | -1.5% | 2,157 | -2.0% |
Total Established Rx Products | 2,266 | -7.9% | 4,586 | -7.1% |
In the second quarter, Established Rx Products sales decreased 7.9% to €2,266 million. This reflected generic competition to Renvela®/Renagel® (sevelamer) in the U.S., which more than offset growth in Emerging Markets (up 7.8% to €965 million). First-half Established Rx Products sales decreased 7.1% to €4,586 million.
Second-quarter Lovenox® sales decreased 2.2% to €377 million, reflecting increased competition in Europe (down 5.8% to €227 million), which offset the growth in Emerging Markets (up 10.6% to €121 million). Biosimilars are available in the UK, Germany and Italy. First-half Lovenox® sales were down 1.5% to €768 million.
In the second quarter, Plavix® sales were up 0.3% to €374 million reflecting generic competition in Japan (sales down 28.1% to €42 million) offset by strong growth in Emerging Markets (up 7.1% to €278 million) driven by China. First-half Plavix® sales increased 4.6% to €761 million.
Second-quarter Aprovel®/Avapro® sales decreased 6.3% to €171 million, reflecting the strong performance in China offset by the impact of generic competition in Japan. First-half Aprovel®/Avapro® sales decreased 4.7% to €343 million.
Second-quarter Renvela®/Renagel® (sevelamer) sales decreased 57.3% to €100 million, due to generic competition in the U.S. (down 68.9% to €60 million). First-half Renvela®/Renagel® sales decreased 55.7% to €201 million.
Generics
In the second quarter, Generics sales decreased 1.6% to €402 million. Sales in Emerging Markets sales were up 5.3% (to €172 million) and sales in Europe were down 3.2% (to €183 million). In June, Sanofi and Advent International finished negotiations for the acquisition by Advent of Zentiva, Sanofi's European generics business and the companies signed a Share Purchase Agreement worth €1.9 billion (enterprise value). The transfer of the Zentiva business to Advent is anticipated during the course of the fourth quarter 2018. The transaction remains subject to approval of the regulatory authorities.
Consumer Healthcare
CHC sales by geography and category are provided in Appendix 1.
Net sales (€ million) | Q2 2018 | Change at CER | H1 2018 | Change at CER |
Allergy Cough & Cold | 239 | +2.0% | 580 | -4.2% |
of which Allegra® | 99 | +1.9% | 229 | +2.0% |
of which Mucosolvan® | 22 | +53.3% | 49 | +13.0% |
of which Xyzal® | 7 | - | 21 | -52.9% |
Pain | 304 | +10.4% | 628 | +9.6% |
of which Doliprane® | 77 | +6.8% | 161 | +4.5% |
of which Buscopan® | 50 | +39.0% | 104 | +42.2% |
Digestive | 248 | +8.6% | 496 | +11.7% |
of which Dulcolax® | 56 | +3.6% | 109 | +12.6% |
of which Enterogermina® | 45 | +16.7% | 94 | +14.6% |
of which Essentiale® | 46 | +8.9% | 89 | +11.8% |
of which Zantac® |
By: Nasdaq / GlobeNewswire
- 31 Jul 2018
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