icon-avatar

Empresas

Empresas y finanzas

Ipsen´s First Quarter 2016 Sales

    Regulatory News:

    Ipsen (Euronext: IPN; ADR: IPSEY) today reported its sales for the first quarter 2016.

    First quarter 2016 unaudited IFRS consolidated sales

    		  
                                       
    (in million euros)       Q1 2016       Q1 2015       % Change      

    % Change at
    constant
    currency

    		  
                                       
    Specialty care       288.1       265.7       8.4%       9.7%  
    of which Somatuline®       121.7       89.3       36.3%       36.3%  
    of which Decapeptyl®       78.2       82.9       -5,6%       -4.6%  
    of which Dysport®       63.2       68.6       -7.9%       -4.2%  
    Primary care*       73.9       84.4       -12.4%       -11.0%  
    of which Smecta®       29.3       35.9       -18.6%       -16,9%  
    of which Forlax®       10.0       9.1       10.6%       11.5%  
    of which Tanakan®       9.8       10.5       -6.9%       -4.1%  
    Group Sales       362.0       350.1       3.4%       4.7%  

    * Drug-related sales (active ingredients and raw materials) are recorded within Primary care sales.

    Commenting on the first quarter 2016 performance, Marc de Garidel, Chairman and Chief Executive Officer of Ipsen said: “In the first quarter, the Group continued to benefit from the acceleration of the growth of Somatuline® in neuroendocrine tumors, both in the United States and Europe. However, the environment in emerging markets, especially in China, is still adversely affecting the performance of Decapeptyl® and the primary care.” Marc de Garidel added: “We are fully committed, upon regulatory approval, to preparing the upcoming commercial launches of cabozantinib in advanced renal cell carcinoma in Europe, and Dysport® in pediatric lower limb spasticity in the United States.”

    1 Year-on-year growth excluding foreign exchange impacts

    First quarter 2016 sales highlights

    Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts.

    Consolidated Group sales grew 4.7% to €362.0 million.

    Sales of Specialty care products reached €288.1 million, up 9.7% year-on-year. Oncology sales grew by 16.3% while neurosciences and endocrinology sales decreased by respectively 3.9% and 1.4%. The relative weight of specialty care continued to increase to reach 79.6% of Group sales, compared to 75.9% the previous year.

    Sales of Somatuline®reached €121.7 million, up 36.3%, driven by a strong growth in North America following the launch of the new indication of neuroendocrine tumors at the beginning of 2015, and the strong performance in most European countries, notably in Germany, France, Poland, Italy and the UK.

    Sales of Dysport® reached €63.2 million, down 4.2% year-on-year impacted by unfavorable inventory effects in the aesthetic indication through the Galderma partnership. These effects were partly offset by a very good performance in Russia and to a lesser extent in Germany and the United States with a limited growth in therapeutic sales.

    Sales of Decapeptyl® reached €78.2 million, down 4.6% year-on-year, mainly impacted by negative inventory effects in the Middle East and Algeria. In China, the product suffered from a high comparison base in the first quarter 2015, and from increased price pressure in some provinces. However, the product registered a good performance in some European countries especially in Russia, the United Kingdom and Belgium.

    Primary care sales reached €73.9 million, down 11.0% year-on-year. International sales declined 13.7%, while sales were down 3.6% in France. Over the period, primary care sales represented 20.4% of total Group sales, compared to 24.1% the previous year.

    Sales of Smecta® reached €29.3 million, down 16.9% year-on-year, affected by inventory effects in China related to the change in business model in a slower market.

    Sales of Forlax® reached €10.0 million, up 11.5%, driven by supply sales to the Group’s partners in charge of marketing the generic versions of the product.

    Sales of Tanakan®reached €9.8 million, down 4.1% year-on-year, penalized by a market slowdown in France and in Russia.

    2016 financial objectives

    The Group confirms its financial targets for 2016:

    • Specialty care sales growth year-on-year in excess of 10.0%;
    • Slight primary care sales growth year-on-year;
    • Core operating margin of around 21%, including the impact from the investment required to prepare the commercial launch of cabozantinib for the treatment of advanced renal cell carcinoma in Europe.

    Sales objectives are set at constant currency.

    About Ipsen

    Ipsen is a global specialty-driven biotechnological group with total sales exceeding €1.4 billion in 2015. Ipsen sells more than 20 drugs in more than 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its fields of expertise cover oncology, neurosciences and endocrinology. Ipsen’s commitment to oncology is exemplified through its growing portfolio of key therapies improving the care of patients suffering from prostate cancer, bladder cancer and neuro-endocrine tumors. Ipsen also has a significant presence in primary care. Moreover, the Group has an active policy of partnerships. Ipsen´s R&D is focused on its innovative and differentiated technological platforms, peptides and toxins, located in the heart of the leading biotechnological and life sciences hubs (Les Ulis/Paris-Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2015, R&D expenditure totaled close to €193 million. The Group has more than 4,600 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol 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 favourable 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 2015 Registration Document available on its website (www.ipsen.com).

    Comparison of consolidated sales for the first quarters 2016 and 2015:

    Sales by therapeutic area and by product1

    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 first quarters 2016 and 2015:

               
            1st quarter  
       
    (in million euros)       2016       2015       % Variation      

    % Variation at
    constant currency

    		  
                                       
    Oncology       204.4       176.5       15.8 %       16.3%  
    of which Somatuline®       121.7       89.3       36.3%       36.3%  
    of which Decapeptyl®       78.2       82.9       -5.6%       -4.6%  
    of which Hexvix®       4.5       4.3       3.5%       3.6%  
    Neurosciences       63.6       68.8       -7.6%       -3.9%  
    of which Dysport®       63.2       68.6       -7.9%       -4.2%  
    Endocrinology       20.1       20.4       -1.4%       -1.4%  
    of which NutropinAq®       15.1       15.8       -4.2%       -3.8%  
    of which Increlex®       5.0       4.6       8.3%       6.8%  
    Specialty care       288.1       265.7       8.4%       9.7%  
                                       
    Gastroenterology       51.0       59.2       -13.9%       -12.4%  
    of which Smecta®       29.3       35.9       -18.6%       -16.9%  
    of which Forlax®       10.0       9.1       10.6%       11.5%  
    Cognitive disorders       9.8       10.5       -6.9%       -4.1%  
    of which Tanakan®       9.8       10.5       -6.9%       -4.1%  
    Other Primary Care       6.6       8.0       -16.9%       -16.9%  
                                       
    Drug-related sales*       6.5       6.7       -2.6%       -2.7%  
                                       
    Primary care       73.9       84.4       -12.4%       -11.0%  
                                       
    Group sales       362.0       350.1       3.4%       4.7%  

    * Drug-related sales (active ingredients and raw materials) are recorded within Primary care sales

    In the first quarter 2016, sales reached €362.0 million, up 4.7%, driven by the 9.7% growth of specialty care sales, while primary care sales declined 11.0%.

    In the first quarter 2016, sales of Specialty care products reached €288.1 million, up 9.7% year-on-year. Oncology sales grew by 16.3% while neurosciences and endocrinology sales decreased by respectively 3.9% and 1.4%. The relative weight of specialty care continued to increase to reach 79.6% of Group sales, compared to 75.9% the previous year.

    In oncology, sales reached €204.4 million in the first quarter 2016, up 16.3% year-on-year, continuously driven by the acceleration of Somatuline® growth. Somatuline®sales reached €121.7 million, up 36.3%, driven by a strong growth in North America following the launch of the new indication of neuroendocrine tumors at the beginning of 2015 and by a strong performance in most European countries, notably in Germany, France, Poland, Italy and the UK. Sales of Decapeptyl® reached €78.2 million, down 4.6% year-on-year, mainly impacted by negative inventory effects in the Middle East and Algeria. In China, the product suffered from a high comparison base in the first quarter 2015, and from increased price pressure in some provinces. However, the product registered a good performance in some European countries especially in Russia, the United Kingdom and Belgium. Sales of Hexvix® reached €4.5 million, up 3.6%, mainly driven by the good performance in Germany, which accounted for 69.5% of total product sales. Over the period, oncology sales represented 56.5% of total Group sales, compared to 50.4% a year earlier.

    In neurosciences, sales of Dysport® reached €63.2 million in the first quarter 2016, down 4.2% year-on-year impacted by unfavorable inventory effects in the aesthetic indication through the Galderma partnership. These effects were partly offset by a very good performance in Russia and to a lesser extent in Germany and the United States with a limited growth in therapeutic sales. Over the period, neurosciences sales represented 17.6% of total Group sales, compared to 19.7% the previous year.

    In endocrinology, sales of NutropinAq®reached €15.1 million, down 3.8% year-on-year, impacted by lower volumes especially in Germany and Italy. Sales of Increlex® reached €5.0 million, up 6.8% year-on-year, notably driven by France. Over the period, endocrinology sales represented 5.6% of total Group sales, compared to 5.8% the previous year.

    In the first quarter 2016, Primary care sales reached €73.9 million, down 11.0% year-on-year, mainly impacted by lower Smecta® sales. International sales declined 13.7%, while sales were down 3.6% in France. Over the period, primary care sales represented 20.4% of total Group sales, compared to 24.1% the previous year.

    In the first quarter 2016, gastroenterology sales reached €51.0 million, down 12.4% year-on-year, affected by inventory effects in China on Smecta®in a slower market, on Etiasa® following the transfer to local production, and on Fortrans®in Russia following product shortage at the beginning of the year. Sales of Forlax® increased 11.5%, driven by supply sales to the Group’s partners in charge of marketing the generic versions of the product.

    In the cognitive disorders area, sales of Tanakan®reached €9.8 million in the first quarter 2016, down 4.1% year-on-year, penalized by a market slowdown in France and in Russia.

    Sales of Other primary care productsreached €6.6 million in the first quarter 2016, down 16.9% year-on-year, mainly affected by the 14.0% decline of Nisis®/Nisisco®, penalized by an additional 40.0% price cut in February 2015 in France, and by Adrovance® sales, down 12.0% sales over the quarter.

    In the first quarter 2016, Drug-related sales (active ingredients and raw materials) reached €6.5 million, down 2.7% year-on-year. The solid supply sales of Gingko Biloba extracts to Group’s partner Schwabe did not compensate the unfavorable inventory effects in Korea and Egypt.

    1 New sales reporting according to the main therapeutic indication of each product

    Sales by geographical area

    Group sales by geographical area in the first quarters of 2016 and 2015 were as follows:

               
            1st quarter  
               
    (in million euros)       2016       2015       % Variation      

    % Variation at
    constant currency

    		  
                                       
    France       55.1       54.1       1.9%       1.9%  
    Germany       29.4       26.5       10.8%       10.8%  
    Italy       21.6       21.1       1.9%       1.9%  
    United Kingdom       18.5       18.4       0.4%       3.7%  
    Spain       16.9       16.8       0.5%       0.5%  
    Major Western European countries       141.5       137.0       3.2%       3.7%  
    Eastern Europe       39.5       39.4       0.4%       6.4%  
    Others Europe       40.9       37 .4       9.3%       10.0%  
    Other European Countries       80.4       76.8       4.7%       8.1%  
                                       
    North America       53.4       29.8       79.0%       74.7%  
    Asia       46.0       59.7       -22.9%       -22.1%  
    Other countries in the Rest of the world       40.7       46.8       -12.9%       -8.4%  
    Rest of the World       86.7       106.5       -18.6%       -16.1%  
                                       
    Group sales       362.0       350.1       3.4%       4.7%  
                                       

    In the first quarter 2016, sales generated in the Major Western European countries reached €141.5 million, up 3.7% year-on-year. Sales in the Major Western European countries, stable year-on-year, represented 39.1% of total Group sales.

    France – In the first quarter 2016, sales reached €55.1 million, up 1.9% year-on-year, driven by the sustained growth of Somatuline® and NutropinAq®. Primary care sales continued to deteriorate, notably due to Tanakan® and Nisis®/Nisisco®,but partlycompensated by a good performance of Forlax®. The relative weight of France in the Group’s consolidated sales has continued to decrease to represent 15.2% of total Group sales, compared to 15.5% the previous year.

    Germany – In the first quarter 2016, sales reached €29.4 million, up 10.8% year-on-year, driven by strong growth of Somatuline® and Dysport®. Over the period, sales in Germany represented 8.1% of total Group sales, compared to 7.6% the previous year.

    Italy – In the first quarter 2016, sales reached €21.6 million, up 1.9% year-on-year. The strong growth of Somatuline® was partly offset by sales decline in Dysport® and NutropinAq®. Over the period, sales in Italy represented 6.0% of total Group sales, stable year-on-year.

    United Kingdom – In the first quarter 2016, sales reached €18.5 million, up 3.7% year-on-year, driven by Somatuline® and Decapeptyl® growth and a positive impact from the 2016 price adjustment mechanism (PPRS1). Over the period, the United Kingdom represented 5.1% of total Group sales, compared to 5.3% the previous year.

    Spain – In the first quarter 2016

    WhatsAppFacebookFacebookTwitterTwitterLinkedinLinkedinBeloudBeloudBluesky