Sanofi Delivers 2017 Business EPS(1) in line with Guidance
Paris, February 7, 2018
Sanofi Delivers 2017 Business EPS(1) in line with Guidance
Q4 2017 | Change | Change at CER | Change at CER/CS(2) | 2017 | Change | Change at CER | Change at CER/CS(2) | |
IFRS net sales reported | €8,691m | -2.0% | +4.1% | -1.6% | €35,055m | +3.6% | +5.6% | +0.5% |
IFRS net income reported | €129m | -83.7% | - | - | €8,434m | +79.1% | - | - |
IFRS EPS reported | €0.10 | -83.9% | - | - | €6.71 | +83.3% | - | - |
Business net income(1) | €1,332m | -17.1% | -10.8% | - | €6,964m | -4.7% | -2.6% | - |
Business EPS(1) | €1.06 | -15.2% | -8.8% | - | €5.54 | -2.5% | -0.4% | - |
Fourth-quarter and 2017 accounts reflect the acquisition of the former Boehringer Ingelheim Consumer Healthcare (CHC) business and the disposal of the Animal Health business (completed on January 1, 2017). In accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations), Animal Health results in 2016 and gain on disposal in 2017 are reported separately. Fourth-quarter and 2017 income statements also reflect the consolidation of European operations related to Sanofi vaccine portfolio, following the termination of the Sanofi Pasteur MSD joint venture (SPMSD JV) with Merck at the end of 2016.
Q4 2017 sales reflect strong Dupixent® launch offset by anticipated declines in U.S. diabetes and Renagel®
- Net sales were €8,691 million, down 2.0% on a reported basis and up 4.1%(3) at CER. At CER/CS(3), net sales were down 1.6%.
- Strong Sanofi Genzyme sales growth (up 16.8%) driven by contribution from new immunology franchise.
- Sanofi Pasteur sales increased 1.2% at CER/CS impacted by order phasing effects and Dengvaxia®.
- CHC sales grew 2.5% at CER/CS.
- Diabetes and Cardiovascular GBU sales down 19.1%.
- Emerging Markets(4) sales increased 2.1% at CER/CS, driven by Pharmaceuticals which increased 4.0% at CER/CS.
Sanofi Genzyme, Sanofi Pasteur and Emerging Markets sales growth more than offset Diabetes sales decline in 2017
- Net sales in 2017 were €35,055 million, up 3.6% on a reported basis and 5.6%(2) at CER. Net sales were up 0.5% at CER/CS.
- Sanofi Genzyme grew 15.1% to €5,674 million while Sanofi Pasteur increased 8.3% (at CER/CS) to €5,101 million.
- Emerging Markets sales were up 6.0% at CER/CS supported by strong performance in China (up 15.1% at CER/CS).
- Diabetes and Cardiovascular GBU sales declined 14.3% to €5,400 million.
Sanofi meets its full-year 2017 business EPS guidance
- Q4 2017 business EPS(1) decreased 8.8% at CER to €1.06, including financial impact from Dengvaxia® (-€0.10).
- 2017 business EPS(1) of €5.54 (-0.4% at CER) and IFRS EPS of €6.71 (+83.3% on a reported basis).
- Net debt was €5,229 million at the end of 2017, a decrease from €8,206 million at the end of 2016.
- Board proposes dividend of €3.03, an increase of 2.4%.
- 2017 business net income (BNI) effective tax rate unaffected by the U.S. tax reform. In 2018, Sanofi expects the BNI effective tax rate to be around 22% primarily as a result of U.S. tax reform(5).
Sanofi progresses on its strategic priorities
- Sanofi to acquire Bioverativ(6) for $11.6 billion to expand in specialty care and strengthen its leadership in rare diseases.
- Sanofi to acquire Ablynx(6) for €3.9 billion to strengthen its R&D strategy with innovative Nanobody® technology platform.
- Agreement signed with Regeneron to accelerate and expand investments for the development of cemiplimab and dupilumab.
- FDA supplemental BLA submission for dupilumab in uncontrolled persistent asthma for adults and adolescents.
2018 financial outlook
- Sanofi expects 2018 business EPS(1) to grow between 2% and 5%(7) at CER, including the anticipated contribution from the recently announced acquisitions, barring unforeseen major adverse events. Applying the average December 2017 exchange rates, the currency impact on 2018 business EPS is estimated to be -3% to -4%.
Sanofi Chief Executive Officer, Olivier Brandicourt, commented: "In 2017, we continued to execute on our strategic goals with the strong launch of Dupixent®, the positive pivotal data for cemiplimab and for dupilumab in asthma. At the same time, we managed the challenges in U.S. diabetes as well as the impact from sevelamer generics and Dengvaxia®. Recently, we announced a series of strategic steps - we are obtaining the global rights to fitusiran and plan to acquire Bioverativ and Ablynx - which will establish Sanofi as a new global leader in rare blood disorders. Additionally, these actions will further strengthen our pipeline and provide us with the powerful new Nanobody® technology platform. Overall, after a period of significant reshaping since 2015, we are positioned to drive growth in 2018." |
(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 2017 and 2017 is provided in Appendix 3 and a reconciliation of IFRS net income reported to business net income is set forth in Appendix 4; (2) CS: constant structure: adjusted for BI CHC business, termination of SPMSD and others; (3) changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 10); (4) See definition page 8; (5) based on current understanding of the US tax reform; (6) Subject to the completion of the acquisition; (7) 2017 business EPS was €5.54
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New segmentation
During 2017, Sanofi has progressively integrated the Consumer Healthcare operations of Boehringer Ingelheim, acquired on January 1, 2017. Following the completion of the integration process and effective December 31, 2017, the CHC business formed a distinct operating segment. Additionally, Sanofi achieved the realignment of its management reporting in accordance with its revised organizational structure in 2017. As a result, the costs of the global functions (Medical Affairs, External Affairs, Finance, Human Resources, Legal Affairs, Information Solutions & Technologies, Sanofi Business Services, etc.) will be included in "Other", as reconciling items to Group numbers. However, comparative information for the previous year will not be restated to reflect the changes described above because the necessary information is not available and would be too complex to develop. The Q1 2018 earnings press release will be based on this new segmentation. Sanofi's Annual report Form 20-F and Document de Référence will contain the information for the year 2017 on both the old basis (with comparative earlier periods) and the segmentation principles.
2018 adoption of IFRS15 and IFRS9
Based on the current assessment, Sanofi does not expect a material revenue recognition change under the new IFRS15 revenue standard which becomes effective in 2018. Sanofi will provide restated figures in the preview document related to Q1 2018. In addition, the Group does not anticipate a material restatement of 2017 Business EPS from the adoption of IFRS9, the new IFRS standard for financial instruments, also effective in 2018.
2017 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 2017, Company sales were €8,691 million, down 2.0% on a reported basis. Exchange rate movements had a negative effect of 6.1 percentage points mainly driven by the movement of the U.S. Dollar accompanied by the Japanese Yen, Turkish Lira and Chinese Yuan. Company sales benefited from the acquisition of Boehringer Ingelheim's CHC business and full consolidation of Sanofi's European vaccines operations leading to an increase of 4.1% at CER. At CER and CS, Company sales were down 1.6%.
2017 Company sales reached €35,055 million, up 3.6% on a reported basis. Exchange rate movements had a negative effect of 2.0 percentage points. At CER and CS, Company sales were up 0.5%.
Global Business Units
The table below presents sales by Global Business Unit (GBU) and reflects the organization of Sanofi. This structure drives deeper specialization, simplifies reporting and provides a clear focus on growth drivers. 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 2017 | Change (CER) | Change CER/CS* | 2017 | Change (CER) | Change CER/CS* | ||
Sanofi Genzyme (Specialty Care)(a) | 1,466 | +16.8% | +16.9% | 5,674 | +15.1% | +15.2% | ||
Diabetes and Cardiovascular(a) | 1,297 | -19.1% | -19.1% | 5,400 | -14.3% | -14.3% | ||
General Medicines & Emerging Markets(b) | 3,347 | -2.3% | -2.7% | 14,048 | -1.0% | -1.3% | ||
Consumer Healthcare (CHC) | 1,196 | +51.8% | +2.5% | 4,832 | +46.3% | +2.1% | ||
Total Pharmaceuticals | 7,306 | +3.3% | -2.1% | 29,954 | +4.2% | -0.8% | ||
Sanofi Pasteur (Vaccines) | 1,385 | +8.7% | +1.2% | 5,101 | +14.5% | +8.3% | ||
Total net sales | 8,691 | +4.1% | -1.6% | 35,055 | +5.6% | +0.5% |
(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 fourth-quarter and full-year 2017 sales by global franchise, including Emerging Markets sales, to facilitate comparisons. Appendix 1 provides a reconciliation of sales by GBU and franchise.
(8) See Appendix 10 for definitions of financial indicators.
*CS: constant structure: adjusted for BI CHC business, termination of SPMSD and others
Net sales by Franchise (€ million) | Q4 2017 | Change (CER) | Change at CER/CS* | Developed Markets | Change at CER/CS* | Emerging Markets | Change at CER/CS* |
Specialty Care | 1,714 | +16.5% | +16.6% | 1,466 | +16.9% | 248 | +15.0% |
Diabetes and Cardiovascular | 1,663 | -14.2% | -14.2% | 1,297 | -19.1% | 366 | +8.7% |
Established Rx Products | 2,298 | -5.5% | -6.0% | 1,397 | -11.4% | 901 | +3.3% |
Consumer Healthcare (CHC) | 1,196 | +51.8% | +2.5% | 796 | +4.1% | 400 | -0.5% |
Generics | 435 | -2.1% | -1.9% | 252 | -0.4% | 183 | -3.8% |
Vaccines | 1,385 | +8.7% | +1.2% | 914 | +5.3% | 471 | -6.1% |
Total net sales | 8,691 | +4.1% | -1.6% | 6,122 | -3.1% | 2,569 | +2.1% |
*CS: constant structure
Net sales by Franchise (€ million) | 2017 | Change (CER) | Change at CER/CS* | Developed Markets | Change at CER/CS* | Emerging Markets | Change at CER/CS* |
Specialty Care | 6,678 | +14.5% | +14.6% | 5,674 | +15.2% | 1,004 | +11.3% |
Diabetes and Cardiovascular | 6,905 | -9.6% | -9.6% | 5,400 | -14.3% | 1,505 | +11.6% |
Established Rx Products | 9,761 | -3.4% | -3.8% | 5,961 | -8.8% | 3,800 | +4.8% |
Consumer Healthcare (CHC) | 4,832 | +46.3% | +2.1% | 3,216 | +1.7% | 1,616 | +3.0% |
Generics | 1,778 | -3.3% | -3.1% | 1,020 | -3.6% | 758 | -2.4% |
Vaccines | 5,101 | +14.5% | +8.3% | 3,526 | +8.6% | 1,575 | +7.6% |
Total net sales | 35,055 | +5.6% | +0.5% | 24,797 | -1.7% | 10,258 | +6.0% |
*CS: constant structure
Pharmaceuticals
Fourth-quarter Pharmaceutical sales were up 3.3% to €7,306 million. At CS, Pharmaceutical sales were down 2.1% primarily due to Diabetes and Established Rx Products. Full-year 2017 sales for Pharmaceuticals increased 4.2% to €29,954 million (down 0.8% at CS).
Rare Disease franchise
Net sales (€ million) | Q4 2017 | Change (CER) | 2017 | Change (CER) |
Myozyme® / Lumizyme® | 205 | +11.5% | 789 | +10.1% |
Cerezyme® | 183 | +7.1% | 730 | +0.4% |
Fabrazyme® | 180 | +6.0% | 722 | +9.2% |
Aldurazyme® | 48 | +4.0% | 207 | +5.5% |
Cerdelga® | 33 | +20.7% | 126 | +20.8% |
Others Rare Diseases | 77 | +3.8% | 314 | -1.2% |
Total Rare Disease | 726 | +8.0% | 2,888 | +6.0% |
In the fourth quarter, Rare Disease sales increased 8.0% to €726 million driven by Europe (up 12.3% to €255 million) and Emerging Markets (up 11.8% to €129 million). In the U.S., Rare Disease sales grew 5.2% to €259 million in the fourth quarter. In 2017, Rare Disease sales increased 6.0% to €2,888 million.
Fourth-quarter Gaucher (Cerezyme® and Cerdelga®) sales were up 8.9% at €216 million supported by additional launches of Cerdelga® and solid Cerezyme® performance. Over this period, Cerezyme® sales were up 7.1% to €183 million and Cerdelga® sales increased 20.7% to €33 million of which €24 million were generated in the U.S. (up 13.0%). Full-year 2017 Gaucher sales increased 2.9% to €856 million.
Fourth-quarter Myozyme®/Lumizyme® sales grew 11.5% to €205 million driven by European sales (up 20.0% to €95 million). Full-year 2017 Myozyme®/Lumizyme® sales increased 10.1% to €789 million.
Fourth-quarter Fabrazyme® sales were up 6.0% to €180 million despite the market entry of a new competitor in Europe and some other markets. Full-year 2017 Fabrazyme® sales were up 9.2% to €722 million.
Multiple Sclerosis franchise
Net sales (€ million) | Q4 2017 | Change (CER) | 2017 | Change (CER) |
Aubagio® | 389 | +13.6% | 1,567 | +23.2% |
Lemtrada® | 112 | +0.9% | 474 | +13.6% |
Total Multiple Sclerosis | 501 | +10.5% | 2,041 | +20.8% |
Fourth-quarter Multiple Sclerosis (MS) sales grew 10.5% to €501 million, driven by Aubagio® performance in the U.S. and Europe. Full-year 2017 MS sales increased 20.8% to €2,041 million.
Fourth-quarter Aubagio® sales increased 13.6% to €389 million driven by the U.S. (up 9.8% to €266 million) and Europe (up 21.5% to €96 million). Full-year 2017 Aubagio® sales increased 23.2% to €1,567 million. In the U.S., all of the pending ANDA litigations associated with Aubagio® (teriflunomide), have been settled and dismissed.
In the fourth quarter Lemtrada® sales were up 0.9% to €112 million driven by Europe (up 10.3% to €42 million). In the U.S., sales were down 10.4% to €56 million, reflecting fewer overall infusions due to the unique short-term dosing regimen with persistent duration of therapeutic effect as well as a more competitive environment. Full-year 2017 Lemtrada® sales increased 13.6% to €474 million.
Immunology franchise
Net sales (€ million) | Q4 2017 | Change (CER) | 2017 | Change (CER) |
Dupixent® | 118 | - | 219 | - |
Kevzara® | 8 | - | 11 | - |
Total Immunology | 126 | - | 230 | - |
Dupixent® (collaboration with Regeneron), which was launched in the U.S. in March for the treatment of moderate-to-severe adult atopic dermatitis (AD), generated sales of €118 million in the fourth quarter. In Europe, Dupixent® was approved at the end of September 2017 for use in adults with moderate-to-severe AD who are candidates for systemic therapy and was launched in Germany in December. Full-year 2017, Dupixent® sales were €219 million.
Kevzara® (collaboration with Regeneron) was launched for rheumatoid arthritis in the U.S. in June and in Germany, the UK and the Netherlands during the second half of 2017. Fourth-quarter and full-year 2017 Kevzara® sales were €8 million and €11 million, respectively.
Oncology franchise
Net sales (€ million) | Q4 2017 | Change (CER) | 2017 | Change (CER) |
Jevtana® | 99 | +14.1% | 386 | +9.8% |
Thymoglobulin® | 72 | 0.0% | 291 | +5.3% |
Taxotere® | 40 | 0.0% | 173 | -0.6% |
Eloxatin® | 44 | +14.6% | 179 | +8.2% |
Mozobil® | 40 | +4.9% | 163 | +9.2% |
Zaltrap® | 22 | +53.3% | 75 | +16.9% |
Others | 44 | -26.2% | 252 | +2.0% |
Total Oncology | 361 | +3.5% | 1,519 | +6.4% |
Fourth-quarter and full-year 2017 oncology sales increased 3.5% to €361 million and 6.4% to €1,519 million, respectively.
Jevtana® sales were up 14.1% to €99 million in the fourth quarter supported by the performance in all regions. Full-year 2017 Jevtana® sales increased 9.8% to €386 million. Thymoglobulin® sales were stable at €72 million and increased 5.3% to €291 million in the fourth quarter and full-year, respectively. Eloxatin® sales increased 14.6% to €44 million in the fourth quarter driven by China. Fourth-quarter Taxotere® sales were stable at €40 million. Full-year 2017 sales of Taxotere® and Eloxatin® were down 0.6% (to €173 million) and up 8.2% (to €179 million), respectively.
Diabetes franchise
Net sales (€ million) | Q4 2017 | Change (CER) | 2017 | Change (CER) |
Lantus® | 1,076 | -20.9% | 4,622 | -17.5% |
Toujeo® | 216 | -4.2% | 816 | +27.0% |
Total glargine | 1,292 | -18.6% | 5,438 | -13.0% |
Apidra® | 97 | +8.4% | 377 | +4.9% |
Amaryl® | 81 | -2.2% | 337 | -1.4% |
Insuman® | 26 | -12.9% | 107 | -15.5% |
BGM (Blood Glucose Monitoring) | 15 | -6.3% | 62 | -6.1% |
Lyxumia® | 5 | -14.3% | 26 | -18.2% |
Soliqua® | 9 | - | 26 | - |
Total Diabetes | 1,533 | -15.6% | 6,395 | -11.1% |
In the fourth quarter, global Diabetes sales decreased 15.6% to €1,533 million, reflecting lower Sanofi glargine (Lantus® and Toujeo®) sales in the U.S. Fourth-quarter U.S. Diabetes sales were down 29.5% to €730 million reflecting exclusions from commercial formularies at CVS and UnitedHealthcare as well as a high basis of comparison in the fourth quarter of 2016. Full-year 2017 U.S. Diabetes sales decreased 22.8% to €3,128 million. Fourth-quarter sales in Emerging Markets increased 8.2% to €363 million. Fourth-quarter sales in Europe increased 1.3% to €323 million reflecting Toujeo® growth. Full-year 2017 global Diabetes sales decreased 11.1% to €6,395 million.
In the fourth quarter, Sanofi glargine (Lantus® and Toujeo®) sales decreased 18.6% to €1,292 million. U.S. Sanofi glargine sales were down 30.9% to €694 million, reflecting the impact of the exclusion from the CVS commercial formulary from January 1, 2017 and from the UnitedHealthcare commercial formulary from April 1, 2017 as well as a high basis of comparison in the fourth quarter of 2016. In Europe, Sanofi glargine sales increased 2.5% to €246 million due to the Toujeo® strong performance despite biosimilar glargine competition in several European markets. Full-year 2017 Sanofi glargine sales decreased 13.0% to €5,438 million.
In the fourth quarter, Lantus® sales were €1,076 million, down 20.9%. In the U.S., Lantus® sales decreased 31.4% to €584 million mainly reflecting lower average net price, the aforementioned impact of formulary exclusions as well as a high basis of comparison in the fourth quarter of 2016. In Europe, fourth-quarter Lantus® sales were €183 million (down 7.5%) due to biosimilar glargine competition and patients switching to Toujeo®. In Emerging Markets, fourth-quarter sales were up 4.9% to €234 million. Full-year 2017 Lantus® sales decreased 17.5% to €4,622 million.
Fourth-quarter Toujeo® sales were €216 million, down 4.2%. In the U.S., fourth-quarter Toujeo® sales were €110 million down 28.4% versus the fourth quarter of 2016 (which was a high basis of comparison). However, Toujeo® sales showed positive trend compared to the third quarter of 2017. In Europe and Emerging Markets, fourth-quarter Toujeo sales were €63 million (up 51.2%) and €25 million (versus €15 million in the fourth quarter of 2016). Full-year 2017 Toujeo® sales increased 27.0% to €816 million.
Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) was launched in the U.S. in January 2017 and SuliquaTM was also launched in some European countries in 2017. Soliqua® 100/33 / SuliquaTM sales were €9 million in the fourth quarter and €26 million in 2017.
Amaryl® sales were €81 million, down 2.2% in the fourth quarter, of which €66 million were generated in Emerging Markets (down 1.4%). Full-year 2017 Amaryl® sales were down 1.4% to €337 million.
Fourth-quarter Apidra® sales increased 8.4% to €97 million. Lower sales in the U.S. (down 10.3% to €25 million) were offset by strong growth in Emerging Markets (up 40.9% to €28 million). Full-year 2017 Apidra® sales increased 4.9% to €377 million.
Cardiovascular franchise
Fourth-quarter Praluent® sales (collaboration with Regeneron) were €53 million, of which €35 million was in the U.S. and €15 million in Europe. This reflected significant payer utilization management restrictions in the U.S. and limited market access in Europe. Full-year 2017 Praluent® sales were €171 million versus €105 million in 2016. Praluent® was launched in France in February 2018.
Fourth-quarter and 2017 Multaq® sales were €77 million (down 11.7%) and €339 million (down 2.5%), respectively.
Established Rx Products
Net sales (€ million) | Q4 2017 | Change (CER) | 2017 | Change (CER) |
Lovenox® | 388 | -2.7% | 1,575 | -2.1% |
Plavix® | 348 | +2.5% | 1,471 | -1.2% |
Renvela®/Renagel® | 155 | -28.5% | 802 | -12.3% |
Aprovel®/Avapro® | 158 | +2.5% | 691 | +3.7% |
Synvisc® /Synvisc-One® | 86 | -16.2% | 387 | -3.9% |
Myslee®/Ambien®/Stilnox® | 59 | -19.0% | 259 | -13.5% |
Allegra® | 32 | -9.8% | 158 | -12.9% |
Other | 1,072 | -3.4% | 4,418 | -2.8% |
Total Established Rx Products | 2,298 | -5.5% | 9,761 | -3.4% |
In the fourth quarter, Established Rx Products sales decreased 5.5% to €2,298 million. This reflected a decline in sales in Europe (down 4.7% to €869 million), together with generic competition to Renvela®/Renagel® in the U.S. and the impact of generic competition to Plavix® in Japan, which more than offset Emerging Markets performance (up 3.2% to €901 million). Full-year 2017 Established Rx Products sales decreased 3.4% to €9,761 million.
Lovenox® sales decreased 2.7% to €388 million in the fourth quarter, reflecting increased competition in Europe (down 9.0% to €231 million) which offset the growth in Emerging Markets (up 5.6% to €120 million). As of September, biosimilars have been introduced in the UK and Germany. Full-year 2017 Lovenox® sales decreased 2.1% to €1,575 million.
In the fourth quarter, Plavix® sales were up 2.5% to €348 million sustained by Emerging Markets performance (up 13.5% to €244 million) driven by China which exceeded the impact of generic competition in Japan (sales in Japan were down 25.6% to €54 million). Full-year 2017 Plavix® sales decreased 1.2% to €1,471 million.
Fourth-quarter Renvela®/Renagel® sales decreased 28.5% to €155 million due to generic competition in the U.S. (down 33.5% to €117 million). In October, Sanofi launched an authorized generic of Renvela®/Renagel® on the U.S. market. Full-year 2017 Renvela®/Renagel® sales decreased 12.3% to €802 million.
Fourth-quarter Aprovel®/Avapro® sales increased 2.5% to €158 million, reflecting strong performance in China which offset lower sales to Sanofi's partner in Japan. Full-year 2017 Aprovel®/Avapro® sales increased 3.7% to €691 million.
Consumer Healthcare
CHC sales by geography and category are provided in Appendix 1.
Net sales (€ million) | Q4 2017 | Change (CER) | Change at CER/CS* | 2017 | Change (CER) | Change at CER/CS* |
Allergy Cough & Cold | 293 | +71.3% | +3.7% | 1,226 | +56.6% | +3.2% |
of which Allegra® | 85 | +8.1% |
By: Nasdaq / GlobeNewswire
- 07 Feb 2018
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