Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today reported its sales for the third quarter and first nine months of 2015.
| Third quarter and first nine months 2015 unaudited IFRS consolidated sales | ||||||||||||||||
| 3rd quarter | 9 months | |||||||||||||||
| (in million euros) | 2015 | 2014 | % Variation | % Variation at constant currency | 2015 | 2014 | % Variation | % Variation at constant currency | ||||||||
| Specialty care | 275.6 | 245.7 | 12.2% | 8.6% | 824.5 | 718.2 | 14.8% | 10.9% | ||||||||
| of which Somatuline® | 103.4 | 74.3 | 39.2% | 33.7% | 291.6 | 213.6 | 36.6% | 30.7% | ||||||||
| of which Decapeptyl® | 81.6 | 82.9 | -1.6% | -6.3% | 250.8 | 243.4 | 3.0% | -1.6% | ||||||||
| of which Dysport® | 68.2 | 66.7 | 2.3% | 1.5% | 208.8 | 195.3 | 6.9% | 5.2% | ||||||||
| Primary care* | 78.9 | 83.3 | -5.4% | -5.0% | 243.8 | 249.5 | -2.3% | -4.1% | ||||||||
| of which Smecta® | 26.7 | 33.8 | -21.0% | -22.8% | 89.1 | 94.6 | -5.8% | -11.2% | ||||||||
| of which Tanakan® | 12.8 | 16.4 | -21.8% | -12.5% | 37.0 | 47.5 | -22.3% | -15.8% | ||||||||
| of which Forlax® | 10.0 | 9.5 | 5.2% | 3.2% | 28.8 | 28.3 | 1.5% | -0.3% | ||||||||
| Group sales | 354.5 | 329.0 | 7.7% | 5.2% | 1068.3 | 967.7 | 10.4% | 7.0% | ||||||||
* Drug-related sales (active ingredients and raw materials) are recorded within Primary care sales
Commenting on the third quarter 2015 performance, Marc de Garidel, Chairman and Chief Executive Officer of Ipsen said: “Specialty care remains our main growth driver thanks to the successful launch of Somatuline® in neuroendocrine tumors in the US and Europe and the growth of Dysport®, notably in the aesthetic indication. Moreover, the challenging environment in emerging markets, especially in China, is still adversely affecting the performance of Decapeptyl® and of the primary care.” Marc de Garidel added: “We are pleased with the positive Phase 3 results for telotristat etiprate released early August, which are an important milestone in our strategy to become global leaders in neuroendocrine tumors.”
1 Year-on-year growth excluding foreign exchange impacts
Review of the third quarter 2015:
Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts.
Consolidated Group sales grew 5.2% to €354.5 million, driven by the performance of specialty care.
Specialty care products reached €275.6 million, up 8.6% year-on-year, supported by the strong growth of Somatuline®,up 33.7% year-on-year.
Somatuline® sales reached €103.4 million, up 33.7% year-on-year, driven by strong growth in North America following the launch of the new indication in neuroendocrine tumors at the beginning of the year, and by a good overall performance in Europe, notably in Germany, Italy and France.
Decapeptyl® sales reached €81.6 million, down 6.3% year-on-year, affected by sales decrease in China in the context of a market slowdown and pricing pressure in some provinces, as well as further contraction of the European pharmaceutical market impacted by additional price reductions.
Dysport® sales reached €68.2 million, up 1.5% year-on-year, driven by the solid performance of the aesthetic indication, notably in Russia, Brazil, Mexico and Australia, yet affected by an unfavorable base effect in the United States arising from the exceptional orders in aesthetics placed by Valeant and taken over by Galderma following the agreement signed between Ipsen and Galderma in July 2014.
Primary care products reached €78.9 million, down 5.0% year-on-year, affected by sales decline of Smecta® in China and of Tanakan® in Russia.
Smecta® sales reached €26.7 million, down 22.8% year-on-year, affected by sales decrease in China due to an unfavorable inventory effect in the distribution channel during the second and third quarters and pricing pressure in some regions, as well as the termination of direct sales in Algeria (where Ipsen now supplies the active ingredient instead of the finished product) and sales decrease in Vietnam (where the majority of sales in the period were anticipated in the first quarter ahead of the import license renewal).
Tanakan® sales reached €12.8 million euros, down 12.5% year-on-year, impacted by a market slowdown in France and in Russia.
Forlax® sales reached €10.0 million, up 3.2% year-on-year, driven by the performance in Algeria and in Russia, despite a sales decline in France, penalized by the “Tiers-Payant1” regulation.
2015 objectives confirmed
As a result of the good performance of Somatuline® and despite the slowdown in emerging markets, Ipsen confirms its 2015 objectives2:
- Specialty care sales growth at or above 14.0% year-on-year
- Primary care sales decline between -3.0% and 0.0% year-on-year
- Core Operating margin at or above 22.0% of Group sales
1 With the “Tiers-Payant” regulation, the patient now pays upfront for a branded drug and is reimbursed only later on
2 Sales objectives are set at constant currency and drug-related sales (active substances and raw materials) are from now on recorded in the Primary Care sales line
About Ipsen
Ipsen is a global specialty-driven biotechnological group with total sales exceeding €1.2 billion in 2014. Ipsen sells more than 20 drugs in more than 115 countries, with a direct commercial presence in 30 countries. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and urology-oncology. 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, France; Slough/Oxford, UK; Cambridge, US). In 2014, R&D expenditure totaled close to €187 million, representing about 15% of Group sales. The Group has more than 4,500 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 2014 Registration Document available on its website (www.ipsen.com).
Comparison of consolidated sales for the third quarter and first nine months 2015 and 2014:
Sales by therapeutic area and by product
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 quarters and first nine months 2015 and 2014:
| 3rd Quarter | 9 months | |||||||||||||||
| (in millions euros) | 2015 | 2014 | % Variation | % Variation at constant currency | 2015 | 2014 | % Variation | % Variation at constant currency | ||||||||
| Urology-oncology | 85.7 | 86.7 | -1.1% | -5.6% | 263.7 | 255.5 | 3,2% | -1.2% | ||||||||
| of which Hexvix® | 4.1 | 3.8 | 9.7% | 9.1% | 12.9 | 12.1 | 6.7% | 6.0% | ||||||||
| of which Decapeptyl® | 81.6 | 82.9 | -1.6% | -6.3% | 250.8 | 243.4 | 3.0% | -1.6% | ||||||||
| Endocrinology | 121.4 | 92.0 | 31.9% | 27.0% | 351.2 | 267.1 | 31.5% | 26.3% | ||||||||
| of which Somatuline® | 103.4 | 74.3 | 39.2% | 33.7% | 291.6 | 213.6 | 36.6% | 30.7% | ||||||||
| of which NutropinAq® | 13.9 | 14.2 | -2.7% | -3.3% | 45.5 | 45.1 | 0.9% | 0.2% | ||||||||
| of which Increlex® | 4.1 | 3.5 | 18.1% | 4.6% | 14.0 | 8.5 | 65.6% | 49.7% | ||||||||
| Neurology | 68.5 | 67.0 | 2.3% | 1.6% | 209.6 | 195.6 | 7.2% | 5.5% | ||||||||
| of which Dysport® | 68.2 | 66.7 | 2.3% | 1.5% | 208.8 | 195.3 | 6.9% | 5.2% | ||||||||
| Specialty care | 275.6 | 245.7 | 12.2% | 8.6% | 824.5 | 718.2 | 14.8% | 10.9% | ||||||||
| Gastroenterology | 53.6 | 56.1 | -4.5% | -6.7% | 167.4 | 166.7 | 0.4% | -4.4% | ||||||||
| of which Smecta® | 26.7 | 33.8 | -21.0% | -22.8% | 89.1 | 94.6 | -5.8% | -11.2% | ||||||||
| of which Forlax® | 10.0 | 9.5 | 5.2% | 3.2% | 28.8 | 28.3 | 1.5% | -0.3% | ||||||||
| Cognitive disorders | 12.8 | 16.4 | -21.8% | -12.5% | 37.0 | 47.5 | -22.3% | -15.8% | ||||||||
| of which Tanakan® | 12.8 | 16.4 | -21.8% | -12.5% | 37.0 | 47.5 | -22.3% | -15.8% | ||||||||
| Cardiovascular | 3.9 | 3.8 | 3.0% | 3.0% | 13.4 | 15.1 | -11.6% | -11.9% | ||||||||
| Other Primary Care | 2.3 | 2.6 | -10.0% | -9.3% | 7.8 | 8.3 | -6.1% | -6.0% | ||||||||
| Drug-related Sales | 6.2 | 4.4 | 39.6% | 38.5% | 18.3 | 11.8 | 55.4% | 54.5% | ||||||||
| Primary care* | 78.9 | 83.3 | -5.4% | -5.0% | 243.8 | 249.5 | -2.3% | -4.1% | ||||||||
| Group Sales | 354.5 | 329.0 | 7.7% | 5.2% | 1068.3 | 967.7 | 10.4% | 7.0% | ||||||||
* Drug-related sales (active ingredients and raw materials) are recorded within Primary care sales.
In the third quarter, sales have reached €354.5 million, up 5.2% year-on-year, driven by specialty care sales growth of 8.6% despite primary care sales decline of 5.0%. In the first nine months 2015, sales amounted to €1 068.3 million, up 7.0% year-on-year.
In the third quarter 2015, sales of Specialty care products reached €275.6 million, up 8.6% year-on-year. In the first nine months 2015, sales amounted to €824.5 million, up 10.9%. Sales in urology-oncology were down 1.2% while sales in endocrinology and neurology grew by respectively 26.3% and 5.5%. The relative weight of specialty care products continued to increase to reach 77.2% of total Group sales, compared to 74.2% the previous year.
In Urology-oncology, sales of Decapeptyl® reached €81.6 million in the third quarter 2015, down 6.3% year-on-year, affected by sales decrease in China in the context of a market slowdown and pricing pressure in some provinces. In the first nine months 2015, sales amounted to €250.8 million, down 1.6%, affected by the slowdown in China as well as the contraction of the European pharmaceutical market with a more frequent use of co-payment in Southern Europe and additional price reductions, notably an 11.0% cut as of 1st January 2015 in Greece and a 3.0% cut as of 1st February 2015 in France and more than 20% in Algeria. In the first nine months 2015, sales of Hexvix® amounted to €12.9 million, up 6.0% compared to the previous year, mostly driven by the performance in France and Germany. Germany represented around 70% of total product sales. Over the period, sales in Urology-oncology represented 24.7% of total Group sales, compared to 26.4% the previous year.
In Endocrinology, sales reached €121.4 million in the third quarter 2015, up 27.0% year-on-year. In the first nine months 2015, sales amounted to €351.2, up 26.3%, representing 32.9% of total Group sales, compared to 27.6% the previous year.
Somatuline® – In the third quarter 2015, sales reached €103.4 million, up 33.7% year-on-year. In the first nine months 2015, sales of Somatuline® grew 30.7%, driven by strong growth in North America following the launch of the new indication of neuroendocrine tumors at the beginning of the year. The product also registered good performance in Europe, notably in Germany, the UK, Spain and France.
NutropinAq® – In the third quarter 2015, sales reached €13.9 million, down 3.3% year-on-year. In the first nine months 2015, sales of NutropinAq® amounted to €45.5 million, up 0.2%, compared to 2014.
Increlex® – In the third quarter 2015, sales reached €4.1 million, up 4.6% year-on-year. In the first nine months 2015, sales of Increlex® amounted to €14.0 million, up 49.7% year-on-year, boosted by a favorable base effect related to the shortage which started mid-June 2013 in the United States and in August 2013 in Europe. Supply gradually resumed in Europe in early 2014 and in the United States in June 2014.
In Neurology, Dysport® sales reached €68.2 million in the third quarter 2015, up 1.5% year-on-year, affected by an unfavorable base effect in the United States related to exceptional orders in the aesthetic segment placed by Valeant and taken over by Galderma following the agreement signed between Ipsen and Galderma in July 2014. In the first nine months 2015, sales amounted to €208.8 million, up 5.2%, driven by the solid performance in the aesthetic indication, notably in Russia, Brazil, Mexico and Australia. Over the period, Neurology sales represented 19.6% of total Group sales, compared to 20.2% a year earlier.
In the third quarter 2015, sales of Primary care products reached €78.9 million, down 5.0% year-on-year, affected by Smecta® sales decrease in China, in Algeria (where Ipsen now supplies the active ingredient of Smecta® instead of the finished product) and in Vietnam (where the majority of sales in the period were anticipated in the first quarter ahead of the import license renewal), as well as by Tanakan® sales decrease in Russia. In the first nine months 2015, sales amounted to €243.8 million, down 4.1% year-on-year. In France, sales of primary care were down 7.8%, penalized by the 7.5% price cut on Smecta® in July 2014 and by the continued erosion of Tanakan® sales. Internationally, sales decreased 2.9%, affected by sales decline in China and Russia, notably on Smecta® and Tanakan®. Primary care sales in France accounted for 24.9% of the Group’s total primary care sales, compared to 26.3% the previous year.
In Gastroenterology, sales reached €53.6 million in the third quarter 2015, down 6.7% year-on-year. In the first nine months 2015, sales amounted to €167.4 million euros, down 4.4% year-on-year.
Smecta® – In the third quarter 2015, sales reached €26.7 million, down 22.8% year-on-year. In the first nine months 2015, sales amounted to €89.1 million euros, down 11.2% year-on-year, affected by sales decrease in China due to an unfavorable inventory effect in the distribution channel during the second and third quarters in a context of pricing pressure in some regions, as well as the termination of direct sales in Algeria. Sales were also affected in France by the price cut implemented in July 2014.
Forlax® – In the third quarter 2015, sales reached €10.0 million, up 3.2% year-on-year, driven by the performance in Algeria and in Russia, despite a sales decline in France, penalized by the “Tiers-Payant1” regulation. In the first nine months 2015, sales amounted to €28.8 million euros, down 0.3% year-on-year.
In the cognitive disorders area, sales of Tanakan®reached €12.8 million euros in the third quarter 2015, down 12.5% year-on-year. Sales in the first nine months 2015 amounted to €37.0 million euros, down 15.8%, impacted by a market slowdown in France and in Russia.
In the cardiovascular area, sales reached €3.9 million euros in the third quarter 2015, up 3.0% year-on-year. In the first nine months 2015, sales amounted to €13.4 million euros, down 11.9%, mainly impacted by the decline of Nisis® / Nisisco® sales, hit by an additional 40.0% price cut in February 2015 in France.
Sales of Other primary care productsreached €2.3 million in the third quarter 2015, down 9.3% year-on-year, mainly affected by the 19.1% decline in Adrovance® sales over the period. In the first nine months 2015, sales amounted to €7.8 million, down 6.0%.
In the third quarter 2015, Drug-related sales (active ingredients and raw materials) reached€6.2 million, up 38.5% year-on-year. In the first nine months 2015, sales amounted to €18.3 million euros, up 54.5%. This performance is mainly explained by the new business model in Algeria where Ipsen now supplies the active ingredient of Smecta® to a local manufacturer and records sales in Drug-related sales, the good performance of the supply of Gingko Biloba extracts to Schwabe Group’s partner, and the sales resumption of Smecta®‘s active ingredient in South Korea.
1 With the “Tiers-Payant” regulation, the patient now pays upfront for a branded drug and is reimbursed only later on
Sales by geographical area
Group sales by geographical area in the third quarters and first nine months 2015 and 2014 were as follows:
| 3rd Quarter | 9 months | |||||||||||||||
| (in million euros) | 2015 | 2014 | % Variation | % Variation at constant currency | 2015 | 2014 | % Variation | % Variation at constant currency | ||||||||
| France | 51.6 | 51.4 | 0.5% | 0.5% | 158.5 | 158.0 | 0.3% | 0.3% | ||||||||
| United Kingdom | 19.4 | 16.9 | 15.1% | 3.5% | 56.5 | 47.2 | 19.6% | 7.0% | ||||||||
| Spain | 15.5 | 15.1 | 2.4% | 2.4% | 48.1 | 44.3 | 8.5% | 8.5% | ||||||||
| Germany | 26.9 | 23.4 | 15.0% | 14.9% | 80.4 | 70.5 | 14.0% | 14.0% | ||||||||
| Italy | 18.0 | 17.0 | 5.8% | 5.8% | 60.0 | 60.8 | -1.3% | -1.3% | ||||||||
| Major Western European countries | 131.5 | 123.8 | 6.2% | 4.6% | 403.5 | 380.9 | 5.9% | 4.4% | ||||||||
| Eastern Europe | 40.3 | 43.4 | -7.0% | 10.5% | 124.4 | 134.0 | -7.2% | 6.0% | ||||||||
| Others Europe | 39.6 | 35.8 | 10.7% | 8.9% | 116,2 | 110.1 | 5.5% | 5.2% | ||||||||
| Other European Countries | 79.9 | 79.1 | 1.0% | 9.7% | 240.6 | 244.2 | -1.5% | 5.6% | ||||||||
| North America | 41.8 | 26.4 | 58.1% | 31.6% | 109.2 | 57.9 | 88.6% | 55.6% | ||||||||
| Asia | 54.7 | 52.3 | 4.7% | -10.6% |
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