Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical group, today reported its sales for the third quarter and first nine months of 2016.
| Third quarter and first nine months 2016 unaudited IFRS consolidated sales | ||||||||||||||||||
| Third Quarter | Nine Months | |||||||||||||||||
| (in million euros) | 2016 | 2015 | % Variation | % Variation at constant currency | 2016 | 2015 | % Variation | % Variation at constant currency | ||||||||||
| Specialty Care | 319.7 | 275.6 | 16.0% | 17.8% | 933.2 | 824.5 | 13.2% | 15.5% | ||||||||||
| of which Somatuline® | 137.0 | 103.4 | 32.5% | 34.1% | 391.9 | 291.6 | 34.4% | 36.0% | ||||||||||
| of which Decapeptyl® | 84.2 | 81.6 | 3.2% | 6.3% | 251.8 | 250.8 | 0.4% | 2.8% | ||||||||||
| of which Dysport® | 73.9 | 68.2 | 8.3% | 9.3% | 213.5 | 208.8 | 2.3% | 5.9% | ||||||||||
| Primary Care | 70.9 | 78.9 | -10.1% | -7.5% | 221.2 | 243.8 | -9.3% | -6.4% | ||||||||||
| of which Smecta® | 25.3 | 26.7 | -5.3% | -1.0% | 79.4 | 89.1 | -10.8% | -6.7% | ||||||||||
| of which Forlax® | 9.0 | 10.0 | -9.9% | -8.8% | 29.1 | 28.8 | 1.1% | 2.5% | ||||||||||
| of which Tanakan® | 8.9 | 12.8 | -30.6% | -31.0% | 27.7 | 37.0 | -25.0% | -23.2% | ||||||||||
| Group sales | 390.6 | 354.4 | 10.2% | 12.2% | 1 154.4 | 1 068.3 | 8.1% | 10.5% | ||||||||||
Commenting on the third quarter 2016 performance, David Meek, Chief Executive Officer of Ipsen said: “We are satisfied with the excellent performance achieved in the third quarter. The momentum of the Specialty Care business accelerated in the third quarter, led by the strong global performance of Somatuline® as well as a strong performance of Dysport® in the US and Decapeptyl® in Europe. The Primary Care business is still experiencing challenges in emerging markets and in the third quarter was particularly adversely impacted by a difficult market environment in Russia and Algeria and a slower ramp-up of the new commercial strategy in China.”
David Meek added: “We advanced several pipeline programs during the quarter, most notably for our oncology portfolio the Cabometyx® program. The recent approval for the second line treatment of advanced Renal Cell Carcinoma (RCC) in Europe and positive clinical results from the CABOSUN study in first line advanced RCC reinforce our conviction in the potential of Cabometyx®. We are fully committed to the launch of Cabometyx® in the first European countries in the coming weeks.”
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1 Year-on-year growth excluding foreign exchange impacts
Third quarter 2016 sales highlights
Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts.
Consolidated Group sales grew 12.2% to €390.6 million.
Sales of Specialty Care products reached €319.7 million, up 17.8% year-on-year. The relative weight of Specialty Care continued to increase to reach 81.8% of Group sales, compared to 77.8% the previous year.
Somatuline® sales reached €137.0 million, up 34.1%, year-on-year, driven by the continued strong growth in the United States, and by a good overall performance in Europe, notably in Germany, France, and the UK.
Decapeptyl® sales reached €84.2 million, up 6.3% year-on-year, supported by strong volume growth in Europe.
Dysport® sales reached €73.9 million, up 9.3% year-on-year, led by a solid performance in the United States, notably in aesthetics through the Galderma partnership. This good performance was negatively impacted by volume declines in Brazil due to importation issues and in Russia due to lower demand.
Primary Care product sales totaled €70.9 million, down 7.5% year-on-year, affected by the decline in sales of Tanakan® in Russia, Forlax® in Algeria, and also the tail portfolio in France.
Smecta® sales reached €25.3 million, down 1.0% year-on-year, affected by the sales decrease in China with a slower ramp-up of the new commercial strategy in China, as well as in France and in Italy despite good performance in Russia.
Forlax® sales amounted to €9.0 million, down 8.8% year-on-year, affected by the sales decline in Algeria where import programs have been suspended and despite good volume growth in France.
Tanakan® sales comprised €8.9 million, down 31.0% year-on-year, impacted by continued market challenges in Russia.
2016 objectives revised
Based on the performance of the first nine months of 2016, the Group raises its guidance for Specialty Care sales to greater or equal to 15% growth and revises its guidance for Primary Care sales to a range of -3% to -5%. The guidance for Core Operating margin is raised to around 22%.
| Previous FY 2016 guidance | Revised FY 2016 guidance | |||
| Specialty Care sales | Growth >+12% | Growth ≥+15% | ||
| Primary Care sales | Slight growth | -3% to -5% | ||
| Core Operating margin1 | Around 21% | Around 22% |
Sales objectives are set at constant currency.
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1 As percentage of net sales
About Ipsen
Ipsen is a global specialty-driven pharmaceutical 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 (adult & pediatric). Ipsen’s commitment to oncology is exemplified through its growing portfolio of key therapies improving the care of patients suffering from neuro-endocrine tumors, prostate cancer, bladder cancer and renal cancer. 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 expenditures neared €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 are 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 trades 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 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 2015 Registration Document available on its website (www.ipsen.com).
Comparison of Consolidated Sales for the Third Quarter and First Nine Months of 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 third quarter and the first nine months of 2016 and 2015:
| Third Quarter | Nine Months | ||||||||||||||||
| (in million euros) | 2016 | 2015 | % Variation | % Variation at constant currency | 2016 | 2015 | % Variation | % Variation at constant currency | |||||||||
| Oncology | 225.6 | 189.1 | 19.3% | 21.5% | 657.5 | 555.4 | 18.4% | 20.3% | |||||||||
| Somatuline® | 137.0 | 103.4 | 32.5% | 34.1% | 391.9 | 291.6 | 34.4% | 36.0% | |||||||||
| Decapeptyl® | 84.2 | 81.6 | 3.2% | 6.3% | 251.8 | 250.8 | 0.4% | 2.8% | |||||||||
| Hexvix® | 4.4 | 4.1 | 6.2% | 6.7% | 13.8 | 12.9 | 6.9% | 7.2% | |||||||||
| Neurosciences | 74.2 | 68.5 | 8.4% | 9.4% | 214.7 | 209.6 | 2.5% | 6.2% | |||||||||
| Dysport® | 73.9 | 68.2 | 8.3% | 9.3% | 213.5 | 208.8 | 2.3% | 5.9% | |||||||||
| Endocrinology | 19.8 | 18.0 | 10.3% | 11.4% | 60.9 | 59.6 | 2.3% | 3.1% | |||||||||
| NutropinAq® | 13.3 | 13.9 | -3.8% | -2.8% | 43.7 | 45.5 | -4.0% | -3.4% | |||||||||
| Increlex® | 6.5 | 4.1 | 57.5% | 58.8% | 17.2 | 14.0 | 23.1% | 23.9% | |||||||||
| Specialty Care | 319.7 | 275.6 | 16.0% | 17.8% | 933.2 | 824.5 | 13.2% | 15.5% | |||||||||
| Gastroenterology | 52.0 | 53.6 | -3.1% | 0.8% | 155.3 | 167.4 | -7.2% | -3.5% | |||||||||
| Smecta® | 25.3 | 26.7 | -5.3% | -1.0% | 79.4 | 89.1 | -10.8% | -6.7% | |||||||||
| Forlax® | 9.0 | 10.0 | -9.9% | -8.8% | 29.1 | 28.8 | 1.1% | 2.5% | |||||||||
| Cognitive Disorders | 8.9 | 12.8 | -30.6% | -31.0% | 27.7 | 37.0 | -25.0% | -23.2% | |||||||||
| Tanakan® | 8.9 | 12.8 | -30.6% | -31.0% | 27.7 | 37.0 | -25.0% | -23.2% | |||||||||
| Other Primary Care | 4.7 | 6.3 | -25.3% | -25.1% | 18.1 | 21.2 | -14.5% | -14.3% | |||||||||
| Drug-related Sales | 5.3 | 6.2 | -13.4% | -13.4% | 20.1 | 18.3 | 9.6% | 9.6% | |||||||||
| Primary Care | 70.9 | 78.9 | -10.1% | -7.5% | 221.2 | 243.8 | -9.3% | -6.4% | |||||||||
| Group Sales | 390.6 | 354.5 | 10.2% | 12.2% | 1 154.4 | 1 068.3 | 8.1% | 10.5% | |||||||||
In the third quarter of 2016, sales reached €390.6 million, up 12.2%, led by the 17.8% growth of Specialty Care sales, while Primary Care sales declined by 7.5%. In the first nine months of 2016, sales amounted to €1,154.4 million, up 10.5%, driven by the 15.5% growth of Specialty Care sales, while Primary Care sales declined by 6.4%.
In the third quarter of 2016, sales of Specialty Care products amounted to €319.7 million, up 17.8% year-on-year. In the first nine months of 2016, sales totaled €933.2 million, up 15.5%. Oncology sales grew by 20.3%, Neurosciences sales grew by 6.2%, and Endocrinology sales by 3.1%. Over the period, the relative weight of Specialty Care continued its increase to reach 80.8% of Group sales, compared to 77.2% in the previous year.
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1 New sales reporting according to main therapeutic indication of each project
In Oncology, sales reached €225.6 million in the third quarter of 2016, up 21.5% year-on-year, driven by the continued acceleration of Somatuline® growth in the United States and in Europe. In the first nine months of 2016, sales amounted to €657.5 million, up 20.3%. Over the period, Oncology sales represented 57.0% of total Group sales, compared to 52.0% in the previous year.
Somatuline®–In the third quarter of 2016, sales reached €137.0 million, up 34.1%. In the first nine months of 2016, sales amounted to €391.9 million, up 36.0%. Somatuline®’s improved performance was driven by strong volume growth and a continued favorable pricing trend in North America and by a strong performance in most European countries, notably in Germany, Poland, and France.
Decapeptyl® – In the third quarter of 2016, sales totaled €84.2 million, up 6.3% year-on-year, led by strong volume growth in Europe. In the first nine months of 2016, sales amounted to €251.8 million, up 2.8%. Decapeptyl®’s growth was negatively impacted by competition and price pressure in China as well as difficulties importing the drug in some Middle East countries.
Hexvix® – In the third quarter of 2016, sales amounted to €4.4 million, up 6.7% year-on-year. In the first nine months of 2016, sales of Hexvix® reached €13.8 million, up 7.2%, mainly driven by the good performance in Germany, which accounts for the majority of product sales.
In Neurosciences, sales of Dysport® reached €73.9 million in the third quarter of 2016, up 9.3% year-on-year, driven by the product strong volume growth in the US aesthetics market. In the first nine months of 2016, sales amounted to €213.5 million, up 5.9%. This was driven by good performances in Russia and Germany and by the aesthetics business in the US with partner Galderma, despite the negative impact of inventory patterns at the beginning of the year and importation issues in the third quarter in Brazil, and difficulties with a partner in Asia. Over the period, Neurosciences sales represented 18.6% of total Group sales, compared to 19.6% for the previous year.
In Endocrinology, sales of NutropinAq®reached €13.3 million in the third quarter of 2016, down 2.8% year-on-year. In the first nine months of 2016, sales amounted to €43.7 million, down 3.4%, impacted by lower volumes, especially in Germany and the UK, and partly offset by a good performance in France. In the third quarter of 2016, sales of Increlex® reached €6.5 million, up 58.8% year-on-year, mostly driven by the United States. In the first nine months of 2016, sales amounted to €17.2 million, up 23.9%. Over the period, Endocrinology sales represented 5.3% of total Group sales, compared to 5.6% in the previous year.
In the third quarter of 2016, Primary Care sales totaled €70.9 million, down 7.5% year-on-year, negatively impacted by Tanakan®andsales of other Primary Care products. In the first nine months of 2016, sales amounted to €221.2 million, down 6.4%, mainly impacted by Tanakan® sales in Russia and lower Smecta® sales in Asia. Over the period, Primary Care sales represented 19.2% of total Group sales, compared to 22.8% in the previous year.
In the third quarter of 2016, Gastroenterology sales reached €52.0 million, up 0.8% year-on-year led by Etiasa® and Fortrans®. In the nine months of 2016, sales amounted to €155.3 million, down 3.5%, negatively impacted by inventory trends in Asia for Smecta® as wellas for Fortrans®in Europe and Asiafollowing the product shortage at the beginning of the year and the delisting of Bedelix® in Algeria.
Smecta® – In the third quarter of 2016, sales reached €25.3 million, slightly down 1.0% year-on-year. The volume growth in Russia was offset by the sales decline in other countries including Ukraine and China. In the first nine months of 2016, sales amounted to €79.4 million, down 6.7%, affected by high inventories in China in the first nine months of 2015 and a slow ramp-up of the new commercial model, as well as inventory build in Vietnam last year for license product renewal, offsetting the good performance in Russia.
Forlax® – In the third quarter of 2016, sales reached €9.0 million, down 8.8% year-on-year. The good performance in France was offset by the sales decline in Algeria where imports have been suspended. In the first nine months of 2016, sales amounted to €29.1 million, up 2.5%, supported by growing sales to partners marketing the generic version of the product and a good performance in Italy.
In the Cognitive Disorders area, sales of Tanakan®reached €8.9 million in the third quarter of 2016, down 31.0% year-on-year, due continued market challenges in Russia. Sales in the first nine month of 2016 amounted to €27.7 million, down 23.2%.
Sales of Other Primary Care productsreached €4.7 million in the third quarter of 2016, down 25.1% year-on-year. In the first nine months of 2016, sales amounted to €18.1 million, down 14.3%, mainly affected by the 20.4% decline of Nisis®/Nisisco® impacted by an additional 40.0% price cut in February 2015 in France, and by the underperformance of Adrovance®, which is down 15.9% over the period.
In the third quarter of 2016, Drug-related Sales (active ingredients and raw materials) reached €5.3 million, down 13.4% year-on-year, mostly affected by import difficulties in Algeria. In the first nine months of 2016, sales amounted to €20.1 million, up 9.6% driven by solid sales to the Group partner Schwabe.
Sales by geographical area
Group sales by geographical area in the third quarter and first nine months of 2016 and 2015:
| Third Quarter | Nine months | ||||||||||||||||
| (in million euros) | 2016 | 2015 | % Variation | % Variation at constant currency | 2016 | 2015 | % Variation | % Variation at constant currency | |||||||||
| France | 52.5 | 51.6 | 1.7% | 1.7% | 164.0 | 158.5 | 3.5% | 3.5% | |||||||||
| Germany | 30.8 | 26.9 | 14.3% | 14.3% | 91.6 | 80.4 | 13.9% | 13.9% | |||||||||
| Italy | 19.4 | 18.0 | 7.8% | 7.8% | 62.4 | 60.0 | 4.0% | 4.0% | |||||||||
| United Kingdom | 17.5 | 19.4 | -10.0% | 7.6% | 54.6 | 56.5 | -3.4% | 6.6% | |||||||||
| Spain | 15.8 | 15.5 | 1.9% | 1.9% | 50.7 | 48.1 | 5.4% | 5.4% | |||||||||
| Major Western European countries | 136.0 | 131.5 | 3.4% | 6.0% | 423.3 | 403.5 | 4.9% | 6.3% | |||||||||
| Eastern Europe | 40.4 | 40.3 | 0.2% | 3.3% | 125.6 | 124.4 | 0.9% | 7.9% | |||||||||
| Others Europe | 41.8 | 39.6 | 5.5% | 5.4% | 125.9 | 116.2 | 8.4% | 8.7% | |||||||||
| Other European Countries | 82.2 | 79.9 | 2.8% | 4.4% | 251.5 | 240.6 | 4.5% | 8.3% | |||||||||
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