Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, today announced sales for the third quarter of 2017.
Financial highlights
Recent pipeline highlights
Key figures
Third quarter and nine months 2017 unaudited IFRS consolidated sales |
||||||||||||||||
Third Quarter | Nine Months | |||||||||||||||
(in million euros) | 2017 | 2016 |
% |
% |
2017 | 2016 |
% |
% |
||||||||
Specialty Care | 396.2 | 319.7 | 23.9% | 26.5% | 1,160.8 | 933.2 | 24.4% | 24.3% | ||||||||
Consumer Healthcare | 73.9 | 70.9 | 4.3% | 5.0% | 228.8 | 221.2 | 3.4% | 2.5% | ||||||||
Group sales | 470.1 | 390.6 | 20.4% | 22.6% | 1,389.6 | 1,154.4 | 20.4% | 20.1% | ||||||||
David Meek, Chief Executive Officer of Ipsen stated: “The excellent performance in the third quarter reflects the continued execution against our 2017 objectives with an accelerated momentum of our Specialty Care business. We achieved several important pipeline milestones during the quarter, notably in Oncology, further strengthening our leadership position in the neuroendocrine tumor market and increasing the potential value of the Cabometyx franchise. We remain focused on the launch execution of our new products and building an innovative and sustainable pipeline.”
____________________
1 Year-on-year growth
excluding foreign exchange impacts
2 Food and Drug
Administration (FDA), European Medicines Agency (EMA), Somatostatin
Analog (SSA)
Third quarter 2017 sales highlights
Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts.
Third quarter 2017 unaudited IFRS consolidated sales |
||||||||
Third Quarter | ||||||||
(in million euros) | 2017 | 2016 |
% Variation |
% |
||||
Specialty Care | 396.2 | 319.7 | 23.9% | 26.5% | ||||
Somatuline® | 173.0 | 137.0 | 26.2% | 29.9% | ||||
Decapeptyl® | 88.2 | 84.2 | 4.7% | 6.4% | ||||
Cabometyx® | 14.3 | 0.0 | NA | NA | ||||
Onivyde® | 17.9 | 0.0 | NA | NA | ||||
Dysport® | 77.4 | 73.9 | 4.8% | 6.1% | ||||
Consumer Healthcare | 73.9 | 70.9 | 4.3% | 5.0% | ||||
Smecta® | 23.3 | 25.3 | -7.8% | -6.4% | ||||
Forlax® | 10.4 | 9.0 | 16.0% | 16.7% | ||||
Tanakan® | 11.2 | 8.9 | 26.1% | 24.7% | ||||
Group sales | 470.1 | 390.6 | 20.4% | 22.6% | ||||
Consolidated Group sales grew 22.6% to €470.1 million.
Sales of Specialty Care products reached €396.2 million, up 26.5% year-on-year.
Somatuline® sales reached €173.0 million, up 29.9%, year-on-year, driven by the continued excellent growth in the United States, and by strong performance in Europe, notably in the UK, Germany and France.
Decapeptyl® sales reached €88.2 million, up 6.4% year-on-year, supported by strong volume growth in China despite some pricing pressure as well as good sales trends in France and Spain.
Cabometyx® sales reached €14.3 million, driven primarily by the performance in France and Germany and also in the Netherlands and in the UK.
Onivyde® sales reached €17.9 million, stable versus the second quarter.
Dysport® sales reached €77.4 million, up 6.1% year-on-year, led by a solid performance in the United States, notably in aesthetics through the Galderma partnership (despite some unfavorable phasing of shipments) and in the Middle East.
Consumer Healthcare product sales totaled €73.9 million, up 5.0% year-on-year, supported by the good performance of Tanakan® in Russia, as well as Bedelix® and Forlax® in Algeria, offset by a new contractual set up in China which started to impact Etiasa® in the third quarter.
Smecta® sales reached €23.3 million, down 6.4% year-on-year, mainly affected by a negative stocking impact in China and the performance in Russia.
Forlax® sales reached €10.4 million, up 16.7% year-on-year, positively impacted by a favorable basis of comparison in Algeria where import programs were suspended in the third quarter of 2016.
Tanakan® sales reached €11.2 million, up 24.7% year-on-year, driven by a rebound of sales in Russia as compared to 2016 which was impacted by challenging market conditions.
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neurosciences and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales close to €1.6 billion in 2016, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,100 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2016 Registration Document available on its website (www.ipsen.com).
Comparison of Consolidated Sales for the Third Quarter and First Nine Months of 2017 and 2016:
Sales by therapeutic area and by product3
Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts.
The following table shows sales by therapeutic area and by product for the third quarter and the first nine months of 2017 and 2016:
3rd Quarter | 9 months | ||||||||||||||
(in millions euros) | 2017 | 2016 |
% |
% Variation |
2017 | 2016 |
% |
% Variation |
|||||||
Oncology | 299.2 | 225.6 | 32.6% | 35.7% | 860.0 | 657.5 | 30.8% | 31.3% | |||||||
Somatuline® | 173.0 | 137.0 | 26.2% | 29.9% | 513.3 | 391.9 | 31.0% | 31.1% | |||||||
Decapeptyl® | 88.2 | 84.2 | 4.7% | 6.4% | 259.1 | 251.8 | 2.9% | 3.8% | |||||||
Cabometyx® | 14.3 | 0.0 | NA | NA | 31.1 | 0.0 | NA | NA | |||||||
Onivyde® | 17.9 | 0.0 | NA | NA | 37.2 | 0.0 | NA | NA | |||||||
Other Oncology | 5.9 | 4.4 | 34.6% | 34.8% | 19.2 | 13.8 | 39.4% | 39.6% | |||||||
Neurosciences | 78.0 | 74.2 | 5.1% | 6.4% | 243.3 | 214.7 | 13.3% | 11.3% | |||||||
Dysport® | 77.4 | 73.9 | 4.8% | 6.1% | 241.0 | 213.5 | 12.9% | 11.0% | |||||||
Rare Diseases | 19.0 | 19.8 | -4.4% | -3.2% | 57.4 | 60.9 | -5.8% | -5.5% | |||||||
NutropinAq® | 12.4 | 13.3 | -6.7% | -6.6% | 39.5 | 43.7 | -9.6% | -9.2% | |||||||
Increlex® | 6.5 | 6.5 | 0.5% | 3.7% | 17.9 | 17.2 | 3.7% | 3.8% | |||||||
Specialty Care | 396.2 | 319.7 | 23.9% | 26.5% | 1,160.8 | 933.2 | 24.4% | 24.3% | |||||||
Smecta® | 23.3 | 25.3 | -7.8% | -6.4% | 82.1 | 79.4 | 3.4% | 2.4% | |||||||
Forlax® | 10.4 | 9.0 | 16.0% | 16.7% | 31.7 | 29.1 | 8.9% | 8.6% | |||||||
Tanakan® | 11.2 | 8.9 | 26.1% | 24.7% | 26.7 | 27.7 | -3.9% | -5.7% | |||||||
Fortrans/Eziclen® | 7.6 | 6.2 | 23.3% | 23.6% | 23.4 | 19.0 | 23.3% | 18.2% | |||||||
Etiasa® | 5.3 | 8.5 | -38.0% | -34.8% | 14.7 | 17.9 | -17.9% | -15.6% | |||||||
Other Consumer Healthcare | 16.1 | 13.0 | 23.7% | 23.5% | 50.2 | 48.1 | 4.4% | 3.9% | |||||||
Consumer Healthcare | 73.9 | 70.9 | 4.3% | 5.0% | 228.8 | 221.2 | 3.4% | 2.5% | |||||||
Group Sales | 470.1 | 390.6 | 20.4% | 22.6% | 1,389.6 | 1,154.4 | 20.4% | 20.1% | |||||||
Nine months 2017 sales highlights
Group sales amounted to €1,389.6 million, up 20.1%, driven by 24.3% growth of Specialty Care sales and 2.5% growth of Consumer Healthcare sales.
Specialty Care sales amounted to €1,160.8 million, up 24.3% year-on-year. Oncology and Neurosciences sales grew by 31.3% and 11.3%, respectively, while Rare Diseases sales decreased by 5.5%. Over the period, the relative weight of Specialty Care continued to increase to reach 83.5% of Group sales, compared to 80.8% in the previous year.
In Oncology, sales reached €860.0 million, up 31.3% year-on-year, driven by the launches of Onivyde®and Cabometyx®, as well as thecontinued strong performance of Somatuline®. Over the period, Oncology sales represented 61.9% of total Group sales, compared to 57.0% in the previous year.
____________________
3 New sales reporting according to
main therapeutic indication of each project
Somatuline®– Sales reached €513.3 million, up 31.1% year-on-year, driven by strong volume growth in North America as well as good performance in most European countries, notably in the UK, Germany and France.
Decapeptyl® – Sales reached €259.1 million, up 3.8% year-on-year, positively impacted by volume growth in Europe, East Middle East and Algeria, as well as a good sales trend in China despite pricing pressure.
Cabometyx® – Sales reached €31.1 million, driven by good performance across Europe, especially in France and Germany which accounted for the majority of product sales.
Onivyde® – Sales amounted to €37.2 million, reflecting two quarters of sales following completion of the acquisition from Merrimack in April 2017.
In Neurosciences, sales of Dysport® reached €241.0 million, up 11.0% year-on-year, driven by the good performance of Galderma in North America as well as strong growth in the Middle East, offset by the aesthetics sales decrease in Brazil due to temporary importation issues. Over the period, Neurosciences sales represented 17.5% of total Group sales, compared to 18.6% in the previous year.
In Rare Diseases, sales of NutropinAq®reached €39.5 million, down 9.2% year-on-year, impacted by lower volumes across Europe especially in Germany. Sales of Increlex® reached €17.9 million, up 3.8% year-on-year, driven by the United States. Over the period, Rare Diseases sales represented 4.1% of total Group sales, compared to 5.3% in the previous year.
Consumer Healthcare sales reached €228.8 million, up 2.5% year-on-year driven the launch of Diosmectal® in Italy following the acquisition of an equity stake in Akkadeas Pharma in January 2017 and the good performance of Fortrans/Eziclen®. Over the period, Consumer Healthcare sales represented 16.5% of total Group sales, compared to 19.2% in the previous year.
Smecta® – Sales reached €82.1 million, up 2.4% year-on-year, driven by the Diosmectal® launch in Italy, Smebiocta® launch in France and Eastern Europe and a good sales dynamic in China reflecting the commercial efforts deployed to support the implementation of the OTx strategy, partly offset by a negative inventory impact in China that occurred in Q3 2017.
Forlax® – Sales reached €31.7 million, up 8.6% year-on-year, driven by growing sales to partners.
Tanakan® – Sales reached €26.7 million, down 5.7 % year-on-year impacted by a continuous market slowdown in France despite higher sales in Russia in the third quarter.
Fortrans/Eziclen® – Sales reached €23.4 million up 18.2% year-on-year helped by favorable basis of comparison after Fortrans® shortage issues in the first half of 2016.
Etiasa® – Sales reached €14.7 million, down 15.6% year-on-year, impacted by accounting changes due to the new contractual set up in China which started to occur in the third quarter of 2017.
Other Consumer Healthcare – Sales reached €50.2 million, up 3.9% year-on-year supported by Prontalgine® and Buscopan® sales despite some pressure on Nisis®/Nisisco® after the price cut that occurred in January 2017.
Sales by geographical area
Group sales by geographical area in the third quarter and first nine months of 2017 and 2016:
3rd Quarter | 9 months | ||||||||||||||
|
|||||||||||||||
(in million euros) | 2017 | 2016 |
% |
% Variation |
2017 | 2016 |
% |
% Variation |
|||||||
France | 58.6 | 52.5 | 11.6% | 11.6% | 182.8 | 164.0 | 11.4% | 11.4% | |||||||
Germany | 38.5 | 30.8 | 25.2% | 25.2% | 108.8 | 91.6 | 18.8% | 18.8% | |||||||
Italy | 19.3 | 19.4 | -0.7% | -0.7% | 68.2 | 62.4 | 9.3% | 9.3% | |||||||
United Kingdom | 19.5 | 17.5 | 11.8% | 17.5% | 57.9 | 54.6 | 6.1% | 15.5% | |||||||
Spain | 17.8 | 15.8 | 12.5% | 12.5% | 53.1 | 50.7 | 4.8% | 4.8% | |||||||
Major Western European |
153.7 | 136.0 | 13.0% | 13.8% | 470.9 | 423.3 | 11.2% | 12.4% | |||||||
Eastern Europe | 44.4 | 40.4 | 9.8% | 8.1% | 142.5 | 125.6 | 13.5% | 6.8% | |||||||
Others Europe | 48.0 | 41.8 | 14.9% | 15.8% | 144.3 | 125.9 | 14.6% | 15.3% | |||||||
Other European countries | 92.4 | 82.2 | 12.4% | 12.0% | 286.8 | 251.5 | 14.1% | 11.0% | |||||||
North America | 119.0 | 71.6 | 66.3% | 74.4% | 339.4 | 189.7 | 78.9% | 78.7% | |||||||
Asia | 50.2 | 54.6 | -8.1% | -3.5% | 150.2 | 156.0 | -3.7% | -1.8% | |||||||
Other countries in the Rest |
54.9 | 46.2 | 18.7% | 18.0% | 142.3 | 134.0 | 6.2% | 3.4% | |||||||
Rest of the World | 105.0 | 100.8 | 4.2% | 6.3% | 292.5 | 289.9 | 0.9% | 0.6% | |||||||
Group Sales | 470.1 | 390.6 | 20.4% | 22.6% | 1,389.6 | 1,154.4 | 20.4% | 20.1% | |||||||
Sales in Major Western European countries reached €470.9 million, up 12.4% year-on-year. Over the period, sales in Major Western European countries represented 33.9% of total Group sales, compared to 36.7% in the previous year.
France – Sales reached €182.8 million, up 11.4% year-on-year, driven by the Cabometyx® launch contribution, the sustained growth of Somatuline® and thepositive sales trend of Decapeptyl®.
Germany – Sales reached €108.8 million, up 18.8% year-on-year, driven by Cabometyx® sales and the strong growth of Somatuline® slightly offset by lower sales in Rare Diseases.
Italy – Sales reached €68.2 million, up 9.3% year-on-year, mainly driven by the launch of Diosmectal® in Italy following the acquisition of an equity stake in Akkadeas Pharma in January 2017, and the good performance of Somatuline®.
United Kingdom – Sales reached €57.9 million, up 15.5% year-on-year, mainly driven by the strong performance of Somatuline® and the first sales contribution of Cabometyx®.
Spain – Sales reached €53.1 million, up 4.8% year-on-year, driven by the good performance of Somatuline® and Decapeptyl®.
Sales in Other European countries reached €286.8 million, up 11.0% year-on-year, supported by the strong performance of Dysport® and the launch of Cabometyx® in certain countries. Over the period, sales in the region represented 20.6% of total Group sales compared to 21.8% in the previous year.
Sales generated in North America reached €339.4 million, up 78.7% year-on-year, supported by continued strong growth of Somatuline®, partially driven by new contracts, the Onivyde® launch contribution and the good performance Dysport® by Galderma in the aesthetics market. Over the period, sales in North America represented 24.4% of total Group sales, compared to 16.4% in the previous year.
Sales in the Rest of the World reached €292.5 million, up 0.6% year-on-year, driven by the good performance of Decapeptyl® in the Middle East and Somatuline® in certain countries, offset by the sales decrease of Dysport® in Brazil due to temporary importation issues and of Etiasa® in China impacted by accounting changes due to the new contractual set up in China. Over the period, sales in the Rest of the World represented 21.1% of total Group sales, compared to 25.1% in the previous year.
MAJOR DEVELOPMENTS
During the first nine months 2017, major developments included:
APPENDIX
RISK FACTORS
The Group operates in an environment which is undergoing rapid change and exposes its operations to a number of risks, some of which are outside its control. The risks and uncertainties set out below are not exhaustive and the reader is advised to refer to the Group’s 2016 Registration Document available on its website (www.ipsen.com).
View source version on businesswire.com: http://www.businesswire.com/news/home/20171025006347/en/
Ipsen
Media
Ian Weatherhead, +44 (0)
7584230549
Vice-President, Corporate External communications
ian.weatherhead@ipsen.com
or
Financial
Community
Eugenia Litz, +44 (0) 1753 627721
Vice-President
Investor Relations
eugenia.litz@ipsen.com
or
Brigitte
Le Guennec, +33 (0)1 58 33 51 17
Senior Manager, Corporate
Communications
brigitte.le.guennec@ipsen.com
or
Côme
de La Tour du Pin, +33 (0)1 58 33 53 31
Investor Relations
Manager
come.de.la.tour.du.pin@ipsen.com
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