Sanofi delivers 2018 business EPS growth of 5.1% at CER
Paris, February 7, 2019
Sanofi delivers 2018 business EPS growth of 5.1% at CER
Q4 2018 | Change | Change at CER | 2018 | Change | Change at CER | |
IFRS net sales reported | €8,997m | +3.5% | +3.9% | €34,463m | -1.7% | +2.5% |
IFRS net income reported | €254m | +101.6% | - | €4,306m | -48.8%(2) | - |
IFRS EPS reported | €0.20 | +100.0% | - | €3.45 | -48.5%(2) | - |
Business net income(1) | €1,364m | +2.9% | +4.3% | €6,819m | -1.8% | +4.2% |
Business EPS(1) | €1.10 | +3.8% | +4.7% | €5.47 | -0.9% | +5.1% |
Fourth-quarter sales(3) growth driven by Specialty Care and Vaccines Net sales were €8,997 million, an increase of 3.5% on a reported basis, 3.9%(3) at CER and 2.6% at CER/CS (4). Sanofi Genzyme sales were up 37.4% (16.1% at CER/CS(4)), led by Immunology and Rare Blood Disorder franchises. Vaccines sales increased 9.7%, driven by successful influenza differentiation strategy and Menactra®. CHC sales increased 1.9%, supported by Emerging Markets. DCV(5) GBU sales were down 11.3%; Global Diabetes franchise sales declined 10.5% in line with 2015-2018 guidance. Emerging Markets sales(6) were up 6.0%, reflecting strong performance in Asia. Full-Year 2018 sales growth from new products and Emerging markets more than offset impact of U.S. LoEs Net sales in 2018 were €34,463 million, down 1.7% on a reported basis and grew 2.5% at CER (up 0.6% at CER/CS(4)). Sanofi Genzyme grew 30.8% (+14.2% at CER/CS(4)) to €7,226 million. Vaccines sales increased 2.4% to €5,118 million while CHC sales were up 3.0% to €4,660 million. DCV(5) GBU sales declined 13.8% to €4,511 million. Emerging Markets sales were up 7.5%, supported by strong performance in China (up 12.7%). Sanofi delivers 2018 business EPS at the high end of its guidance range Q4 2018 business EPS(1) up 4.7% at CER to €1.10. Full-Year 2018 business EPS of €5.47 up 5.1% at CER and IFRS EPS of €3.45 (down 48.5%(2)). Board proposes dividend of €3.07, the 25th consecutive increase in dividend. Key achievements in sustaining innovation in R&D Isatuximab met primary endpoint of ICARIA phase 3 study in Relapsed/Refractory Multiple Myeloma. BIVV001 demonstrated sustained high factor levels at once-weekly dosing with data presented at ASH. FDA Priority Review granted for Dupixent® in adolescents with moderate-to-severe atopic dermatitis. R&D strategy evolves towards prioritization of Specialty Care and Vaccines, leveraging technology platforms and data science. 2019 financial outlook Sanofi expects 2019 business EPS(1) to grow between 3% and 5%(7) at CER, barring unforeseen major adverse events. Applying average January 2019 exchange rates, the positive currency impact on 2019 business EPS is estimated to be between 1% to 2%. |
Sanofi Chief Executive Officer, Olivier Brandicourt, commented: "In the fourth quarter, we continued the momentum of the previous quarter and we delivered 5% full-year business EPS growth, at the high end of our guidance. In 2018, we executed on important launches including Dupixent®, Libtayo® and Cablivi®, as the headwinds from our U.S. LoEs began to moderate. Additionally, the acquisitions of Bioverativ and Ablynx provided the foundation to build a leading Rare Blood Disorder franchise and to enhance our biologic discovery capabilities. As we enter 2019, our focus remains on delivering our business priorities and transforming Sanofi to address the evolving business dynamics facing our industry." |
(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 10 for definitions). The consolidated income statement for Q4 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, full-year IFRS net income was up 14.5% and full-year IFRS EPS was up 15.3%; (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 and divestment of European Generics business; (5) DCV: Diabetes and Cardiovascular; (6) See definition page 8; (7) 2018 business EPS was €5.47.
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2018 fourth-quarter and full-year Sanofi sales
Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(8). |
In the fourth quarter of 2018, Company sales were €8,997 million, up 3.5% on a reported basis. Exchange rate movements had a negative effect of 0.4 percentage points mainly driven by the movement of the Turkish Lira, Brazilian Real and Argentine Peso. At CER, Company sales increased 3.9%.
Full-year Company sales reached €34,463 million, down 1.7% on a reported basis. Exchange rate movements had an unfavorable effect of 4.2 percentage points. At CER, Company sales were up 2.5%.
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) | Q4 2018 | Change at CER | 2018 | Change at CER | ||
Sanofi Genzyme (Specialty Care)(a) | 2,054 | +37.4%(c) | 7,226 | +30.8%(d) | ||
Diabetes and Cardiovascular(a) | 1,170 | -11.3% | 4,511 | -13.8% | ||
General Medicines & Emerging Markets(b) | 3,052 | -6.6%(e) | 12,948 | -2.8%(f) | ||
Total Pharmaceuticals | 6,276 | +3.0% | 24,685 | +2.4% | ||
Consumer Healthcare (CHC) | 1,194 | +1.9% | 4,660 | +3.0% | ||
Sanofi Pasteur (Vaccines) | 1,527 | +9.7% | 5,118 | +2.4% | ||
Total net sales | 8,997 | +3.9% | 34,463 | +2.5% |
(a) Does not include Emerging Markets sales - see definition page 8; (b) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care; (c)+16.1% at CS; (d)+14.2% at CS; (e) -1.8% at CS; (f)-1.6% at CS
Global Franchises
The tables below present fourth-quarter and 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) | Q4 2018 | Change at CER | Developed Markets | Change at CER | Emerging Markets | Change at CER |
Specialty Care | 2,328 | +35.2% | 2,054 | +37.4% | 274 | +22.4% |
Diabetes and Cardiovascular | 1,552 | -7.1% | 1,170 | -11.3% | 382 | +7.9% |
Established Rx Products | 2,126 | -6.8% | 1,242 | -13.0% | 884 | +2.9% |
Consumer Healthcare (CHC) | 1,194 | +1.9% | 789 | -0.4% | 405 | +6.4% |
Generics | 270 | -33.8%* | 97 | -61.4%** | 173 | +3.8% |
Vaccines | 1,527 | +9.7% | 1,054 | +13.3% | 473 | +2.5% |
Total net sales | 8,997 | +3.9% | 6,406 | +3.0% | 2,591 | +6.0% |
* +6.7% at CS
**+12.9% at CS
Net sales by Franchise (€ million) | 2018 | Change at CER | Developed Markets | Change at CER | Emerging Markets | Change at CER |
Specialty Care | 8,269 | +29.0% | 7,226 | +30.8% | 1,043 | +18.7% |
Diabetes and Cardiovascular | 6,083 | -7.9% | 4,511 | -13.8% | 1,572 | +13.1% |
Established Rx Products | 8,843 | -6.1% | 5,090 | -14.1% | 3,753 | +6.6% |
Consumer Healthcare (CHC) | 4,660 | +3.0% | 3,072 | -0.1% | 1,588 | +8.9% |
Generics | 1,490 | -9.8%* | 805 | -19.4%** | 685 | +3.0% |
Vaccines | 5,118 | +2.4% | 3,647 | +4.5% | 1,471 | -2.3% |
Total net sales | 34,463 | +2.5% | 24,351 | +0.5% | 10,112 | +7.5% |
* -0.6% at CS
**-3.8% at CS
(8) See Appendix 10 for definitions of financial indicators.
Pharmaceuticals
Fourth-quarter Pharmaceutical sales were up 3.0% to €6,276 million mainly driven by the Immunology and Rare Blood Disorder franchises which were partially offset by Diabetes, Established Rx Products and the disposal of the European generics business. Full-year sales for Pharmaceuticals increased 2.4% to €24,685 million.
Rare Disease franchise
Net sales (€ million) | Q4 2018 | Change at CER | 2018 | Change at CER |
Myozyme® / Lumizyme® | 226 | +10.7% | 840 | +10.8% |
Fabrazyme® | 206 | +14.4% | 755 | +9.8% |
Cerezyme® | 190 | +9.3% | 711 | +6.4% |
Aldurazyme® | 54 | +16.7% | 206 | +6.7% |
Cerdelga® | 44 | +33.3% | 159 | +31.0% |
Others Rare Disease | 74 | -6.5% | 287 | -5.4% |
Total Rare Disease | 794 | +10.9% | 2,958 | +8.3% |
In the fourth quarter, Rare Disease delivered a solid performance with sales up 10.9% to €794 million, driven by Gaucher, Pompe and Fabry therapies. In the U.S. and Europe, fourth-quarter Rare Disease sales grew 8.5% (to €292 million) and 3.1% (to €262 million), respectively, while Emerging Markets sales were up 32.6% to €150 million. Full-year Rare Disease sales increased 8.3% to €2,958 million.
Fourth-quarter Gaucher (Cerezyme® and Cerdelga®) sales were up 13.0% to €234 million, supported by the increasing penetration of Cerdelga® in Europe and the sustained growth of Cerezyme® in Emerging Markets. Fourth-quarter Cerdelga® sales increased 33.3% to €44 million. Full-year Gaucher sales were €870 million, up 10.0%.
Fourth-quarter Pompe (Myozyme®/Lumizyme®) sales grew 10.7% to €226 million, supported by positive trends in naïve patient accruals. Fourth-quarter Myozyme®/Lumizyme® sales increased 18.8% to €79 million in the U.S. and 1.1% to €96 million in Europe, respectively. Full-year Myozyme®/Lumizyme® sales increased 10.8% to €840 million.
Fourth-quarter Fabry (Fabrazyme®) sales grew 14.4% to €206 million. Fourth-quarter sales in the U.S. and Europe increased 9.9% (to €104 million) and 4.8% (to €45 million), respectively. Full-year Fabrazyme® sales were up 9.8% to €755 million.
Multiple Sclerosis franchise
Net sales (€ million) | Q4 2018 | Change at CER | 2018 | Change at CER |
Aubagio® | 446 | +12.6% | 1,647 | +9.3% |
Lemtrada® | 96 | -14.3% | 402 | -11.6% |
Total Multiple Sclerosis | 542 | +6.6% | 2,049 | +4.4% |
Fourth-quarter Multiple Sclerosis (MS) sales were up 6.6% to €542 million, as double-digit Aubagio® sales growth was partially offset by the decline in Lemtrada® sales. Full-year MS sales increased 4.4% to €2,049 million.
Fourth-quarter Aubagio® sales increased 12.6% to €446 million, driven by the U.S. (up 13.5% to €311 million) and Europe (up 12.5% to €108 million). Full-year Aubagio® sales increased 9.3% to €1,647 million.
In the fourth quarter, Lemtrada® sales decreased 14.3% to €96 million due to lower U.S. sales (down 19.6% to €45 million) and European sales (down 11.9% to €37 million), reflecting increased competition. Full-year Lemtrada® sales decreased 11.6% to €402 million.
Immunology franchise
Net sales (€ million) | Q4 2018 | Change at CER | 2018 | Change at CER |
Dupixent® | 280 | +130.5% | 788 | +268.0% |
Kevzara® | 31 | +275.0% | 83 | +663.6% |
Total Immunology | 311 | +139.7% | 871 | +287.0% |
Dupixent® (collaboration with Regeneron) for the treatment of moderate-to-severe atopic dermatitis in adults and moderate-to-severe adolescent and adult asthma generated sales of €280 million in the fourth quarter compared to €118 million in the fourth quarter of 2017. In the U.S., Dupixent® sales reached €225 million in the fourth quarter (up 87.9%). Demand for the product remains strong and total prescriptions (source: IQVIA weekly TRx data) increased 25% sequentially in the fourth quarter, bolstered by the branded DTC campaign and the recent U.S. launch in asthma. Fourth-quarter sales in Europe were €29 million. Full-year Dupixent® sales were €788 million compared to €219 million in the same period of 2017. By the end of 2018, Dupixent® had been launched in 17 countries.
Kevzara® (collaboration with Regeneron) for rheumatoid arthritis generated sales of €31 million in the fourth quarter, of which €23 million was in the U.S. reflecting improved commercial coverage. Kevzara® was launched in 14 countries in Europe in 2018 (included France in the fourth quarter). Full-year Kevzara® sales were €83 million.
Rare Blood Disorder franchise
Net sales (€ million) | Q4 2018 | Change at CER | 2018 | Change at CER |
Eloctate® | 196 | - | 608 | - |
Alprolix® | 95 | - | 285 | - |
Cablivi® | 3 | - | 4 | - |
Total Rare Blood Disorder | 294 | - | 897 | - |
Bioverativ was consolidated in Sanofi's Financial Statements from March 9, 2018. Fourth-quarter sales of the Rare Blood Disorder franchise were €294 million (up 5.7% on a pro forma basis(9)), including non-U.S. sales of €58 million with Japan as the primary contributor. Full-year consolidated sales of the Rare Blood Disorder franchise were €897 million, up 12.5% on a pro forma basis(9).
Eloctate®, a recombinant antihemophilic Factor VIII, indicated for the treatment of hemophilia A, generated sales of
€196 million in the fourth quarter, up 4.3% on a pro forma basis(10). The performance in the U.S., Japan and Australia was partially offset by a decline in sales in Canada following the previously announced tender loss. The competitive dynamics in the U.S. resulted in a deceleration in growth compared with the previous quarter. Full-year consolidated Eloctate® sales were €608 million, up 15.0% on a pro forma basis(10).
Alprolix®, a recombinant coagulation Factor IX, indicated for the treatment of hemophilia B, generated sales of €95 million in the fourth quarter, up 5.3% on a pro forma basis(10). Full-year consolidated Alprolix® sales were €285 million, up 6.6% on a pro forma basis(10).
Cablivi® (caplacizumab) for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), received EU approval in September and was launched in its first market, Germany, in October. Sales in the fourth quarter were €3 million.
Oncology franchise
Net sales (€ million) | Q4 2018 | Change at CER | 2018 | Change at CER |
Jevtana® | 114 | +14.1% | 422 | +13.0% |
Thymoglobulin® | 78 | +9.9% | 297 | +7.2% |
Mozobil® | 47 | +15.0% | 171 | +8.6% |
Eloxatin® | 43 | 0.0% | 182 | +5.0% |
Taxotere® | 38 | -2.5% | 166 | -0.6% |
Zaltrap® | 23 | +14.3% | 91 | +27.0% |
Others | 44 | 0.0% | 165 | -32.1% |
Total Oncology | 387 | +8.1% | 1,494 | +2.1% |
(9) Growth comparing fourth-quarter 2018 sales versus fourth-quarter 2017 sales, and full 2018 sales versus full 2017 sales at CER. Excluding the Sobi contract manufacturing sales and including Cablivi® sales in 2018. Unaudited data. (10) Growth comparing fourth-quarter 2018 sales versus fourth-quarter 2017 sales, and full 2018 sales versus full 2017 sales at CER. Excluding the Sobi contract manufacturing sales. Unaudited data.
Fourth-quarter Oncology sales increased 8.1% to €387 million. Consistent with the Company's portfolio prioritization efforts, Sanofi sold Leukine® on January 31, 2018. Excluding Leukine®, Oncology fourth-quarter sales were up 10.2%. Full-year Oncology sales were up 2.1% to €1,494 million and up 6.3% excluding Leukine®.
Jevtana® sales were up 14.1% to €114 million in the fourth quarter supported by the performance in the U.S. (up 20.0% to €50 million). Full-year Jevtana® sales increased 13.0% to €422 million. In the fourth quarter and full year, Thymoglobulin® sales increased 9.9% (to €78 million) and 7.2% (to €297 million), respectively.
In September, Libtayo® (cemiplimab-rwlc, collaboration with Regeneron) was approved in the U.S. for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo® is the only treatment for advanced CSCC approved by the FDA. U.S. Libtayo® sales were $15 million and were consolidated by Regeneron.
Diabetes franchise
Net sales (€ million) | Q4 2018 | Change at CER | 2018 | Change at CER |
Lantus® | 866 | -19.7% | 3,565 | -19.0% |
Toujeo® | 211 | -2.3% | 840 | +7.2% |
Total glargine | 1,077 | -16.8% | 4,405 | -15.1% |
Apidra® | 89 | -6.2% | 357 | +0.3% |
Amaryl® | 77 | -1.3% | 335 | +4.8% |
Insuman® | 23 | -14.8% | 91 | -12.0% |
Admelog® | 57 | - | 93 | - |
Soliqua® | 27 | +188.9% | 73 | +188.5% |
Total Diabetes | 1,375 | -10.5% | 5,472 | -10.4% |
In the fourth quarter, global Diabetes sales decreased 10.5% to €1,375 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S. Fourth-quarter U.S. Diabetes sales were down 26.3% to €555 million, reflecting the previously announced changes in coverage of the Part D business and a continued decline in average U.S. glargine net prices. Fourth-quarter sales in Emerging Markets increased 7.7% to €376 million. Fourth-quarter sales in Europe decreased 0.6% to €320 million, supported by Toujeo® growth. Full-year global Diabetes sales decreased 10.4% to €5,472 million. This in turn resulted in a CAGR sales decline for the global Diabetes franchise over 2015-2018 of 7.4% at CER, in line with the guidance.
Fourth-quarter glargine (Lantus® and Toujeo®) sales decreased 16.8% to €1,077 million. U.S. glargine sales were down 35.7% to €460 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 were stable ato €245 million reflecting strong Toujeo® performance. Full-year glargine sales decreased 15.1% to €4,405 million. In 2019, Sanofi expects a further net pricing decline for its glargine products in the U.S. as a result of higher rebates needed to maintain broad payer coverage and the increased Part D coverage gap impact.
In the fourth quarter, Lantus® sales were €866 million, down 19.7%. In the U.S., Lantus® sales decreased 37.0% to €379 million, mainly reflecting lower average net price and changes in coverage in Part D. In Europe, fourth-quarter Lantus® sales were €168 million, down 8.2% due to biosimilar glargine competition and patients switching to Toujeo®. In Emerging Markets, fourth-quarter Lantus® sales were up 7.7% to €242 million. Full-year Lantus® sales decreased 19.0% to €3,565 million.
Fourth-quarter Toujeo® sales were €211 million, down 2.3%. In the U.S., fourth-quarter Toujeo® sales were €81 million, down 29.1%. In Europe and Emerging Markets, fourth-quarter Toujeo® sales were €77 million (up 23.8%) and €31 million (up 32.0%), respectively. Full-year Toujeo® sales increased 7.2% to €840 million.
Fourth-quarter Apidra® sales decreased 6.2% to €89 million. Lower sales in the U.S. (down 36.0% to €17 million) offset growth in Emerging Markets (up 10.7% to €29 million). Full-year Apidra® sales increased 0.3% to €357 million.
Amaryl® sales were €77 million, down 1.3% in the fourth quarter, of which €66 million were generated in Emerging Markets (up 1.5%). Full-year Amaryl® sales were up 4.8% at €335 million.
Admelog® (insulin lispro injection) 100 Units/mL, which was launched in the U.S. in April, generated sales of €57 million in the fourth quarter mainly due to access in Managed Medicaid. Full-year Admelog® sales were €93 million.
Fourth-quarter and full-year Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) and Suliqua(TM) sales were €27 million and €73 million, respectively.
Cardiovascular franchise
Net sales (€ million) | Q4 2018 | Change at CER | 2018 | Change at CER |
Praluent® | 82 | +50.9% | 261 | +56.1% |
Multaq® | 95 | +20.8% | 350 | +7.1% |
Total cardiovascular franchise | 177 | +33.1% | 611 | +23.5% |
Fourth-quarter Praluent® (collaboration with Regeneron) sales increased 50.9% to €82 million. U.S. sales of €52 million (up 45.7%) benefited from ESI coverage exclusivity which began in the third quarter. In Europe, sales were €23 million (up 53.3%). Full-year Praluent® sales increased 56.1% to €261 million. In 2019, Sanofi expects higher U.S. rebates to impact Praluent® sales.
Fourth-quarter and full-year Multaq® sales were up 20.8% (to €95 million) and 7.1% (to €350 million), respectively.
Established Rx Products
Net sales (€ million) | Q4 2018 | Change at CER | 2018 | Change at CER |
Lovenox® | 346 | -9.0% | 1,465 | -3.0% |
Plavix® | 328 | -4.9% | 1,440 | +1.2% |
Aprovel®/Avapro® | 151 | -2.5% | 652 | -1.7% |
Renvela®/Renagel® | 96 | -39.4% | 411 | -46.7% |
Synvisc® /Synvisc-One® | 81 | -7.0% | 313 | -15.0% |
Myslee®/Ambien®/Stilnox® | 59 | -1.7% | 231 | -6.9% |
Allegra® | 26 | -21.9% | 124 | -17.7% |
Other | 1,039 | -2.5% | 4,207 | -1.8% |
Total Established Rx Products | 2,126 | -6.8% | 8,843 | -6.1% |
In the fourth quarter, Established Rx Products sales decreased 6.8% to €2,126 million, reflecting lower U.S. sales of Renvela®/Renagel® (sevelamer) due to generic competition, together with lower sales of Lovenox® in Europe and Plavix® in Japan. Full-year Established Rx Products sales decreased 6.1% to €8,843 million.
Fourth quarter Lovenox® sales decreased 9.0% to €346 million, reflecting biosimilar competition in the UK, Poland, Germany, Italy and France. Sales in Europe were down 13.9% to €199 million impacted mainly by price erosion in France and Germany triggered by biosimilar launches. In Emerging Markets, Lovenox® sales grew 3.3% to €117 million. Full-year Lovenox® sales were down 3.0% to €1,465 million
In the fourth quarter, Plavix® sales were down 4.9% to €328 million. The decline was mainly driven by generic penetration in Japan (sales down 31.5% to €38 million) and procurement timing in the Middle East. Plavix® sales continued to grow in China. Sales of the product decreased in the rest of Emerging Markets and increased 2.9% in Europe. Full-year Plavix® sales were up 1.2% to €1,440 million.
Fourth-quarter Aprovel®/Avapro® sales decreased 2.5% to €151 million due to loss of exclusivity in Japan in December 2017. In Emerging Markets, performance continued to be strong with sales up 8.6% to €112 million. Full-year Aprovel®/Avapro® sales decreased 1.7% to €652 million.
Fourth-quarter Renvela®/Renagel® (sevelamer) sales decreased 39.4% to €96 million due to generic competition in the U.S. (down 53.0% to €57 million). Full-year Renvela®/Renagel® sales decreased 46.7% to €411 million.
Generics
In the fourth quarter, Generics sales decreased 33.8% to €270 million, reflecting the divestment of the European generics business Zentiva at the end of the third quarter. This divestiture was consistent with Sanofi's strategy to simplify and reshape the company. At CS, fourth quarter Generic sales increased 6.7%. Emerging Markets Generics sales increased 3.8% to €173 million. Full-year Generics sales decreased 9.8% to €1,490 million and decreased 0.6% at CS.
Consumer Healthcare
CHC sales by geography and category are provided in Appendix 1.
Net sales (€ million) | Q4 2018 | Change at CER | 2018 | Change at CER |
Allergy Cough & Cold | 268 | -6.3% | 1,124 | -1.7% |
By: Nasdaq / GlobeNewswire
- 07 Feb 2019
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