On Apriil 26, 2018 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales for the first quarter of 2018 (Press release, Ipsen, APR 26, 2018, View Source [SID1234526809]).
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Q1 2018 Financial highlights:
Group sales growth of 23.1%, driven by Specialty Care sales growth of 27.4%, reflecting continued Somatuline momentum and increasing contribution from Cabometyx and Onivyde
Full year 2018 guidance confirmed with Group sales growth greater than 16.0% and Core Operating Income margin greater than 28.0% of net sales
Q1 2018 Pipeline highlights:
Positive opinion issued by the CHMP for Cabometyx for the first-line treatment of adults with intermediate or poor risk advanced renal cell carcinoma (aRCC)
Validation by the EMA of the filing for an additional indication for Cabometyx for patients with previously treated advanced Hepatocellular Carcinoma (HCC)
In the first quarter of 2018, Consolidated Group sales rose to €510.3 million. Sales grew by 23.1% at constant exchange rates driven by Specialty Care sales growth of 27.4%. Reported Group sales grew by 16.5%, impacted by the appreciation of the euro against a number of currencies, notably the U.S. dollar.
David Meek, Chief Executive Officer of Ipsen stated: "The first quarter of 2018 marked a robust start to the year. Specialty Care drove the growth of Group sales due to the continued strong momentum of Somatuline and the execution of the Cabometyx and Onivyde launches. We also made significant advancements during the period to expand the market potential of Cabometyx, which further strengthens our presence in Oncology. We remain focused on the execution of our commercial products and identifying new business development opportunities to maintain the sustainable longer-term growth of the company."
Conference call
Ipsen will host a conference call on Thursday 26 April 2018 at 2:30 p.m. (Paris time, GMT+1). Details provided on page 7.
Group sales reached €510.3 million, up 23.1%, driven by 27.4% growth of Specialty Care sales and 0.8% growth of Consumer Healthcare sales.
Specialty Care sales amounted to €440.4 million, up 27.4%. Oncology and Neuroscience sales grew by 36.9% and 4.7%, respectively, and Rare Diseases sales increased by 0.3%. Over the period, the relative weight of Specialty Care continued to increase to reach 86.3% of Group sales, compared to 83.7% in 2017.
In Oncology, sales reached €337.0 million, up 36.9% year-on-year, driven by the continued strong performance of Somatuline as well as the launches of Onivyde and Cabometyx. Over the period, Oncology sales represented 66.0% of total Group sales, compared to 59.6% in 2017.
Somatuline – Sales reached €195.7 million, up 25.1% year-on-year, driven by a strong growth of 39.7% in North America, a solid performance in most European countries, notably in France, the United Kingdom and Germany, as well as the contribution from Japan following the launch of the neuroendocrine tumor indication in 2017.
Decapeptyl – Sales totaled €83.1 million, up 9.2% year-on-year, positively impacted by good volume growth, notably in France, Algeria and Ukraine, and also in China despite pricing pressure.
Cabometyx – Sales reached €28.2 million, driven by good performance in Germany, France and the UK, as well as by volume growth in Spain, Italy and new launches in other European countries. In the first quarter of 2018, sales were up 37.2% versus the fourth quarter of 2017, positively impacted by inventory build up in newly reimbursed territories.
Onivyde – Sales amounted to €23.8 million. In the first quarter of 2018, sales were up 28.1% versus the fourth quarter of 2017, reflecting a progressive sales ramp in the U.S. and increasing sales to Ipsen’s European partner.
In Neuroscience, sales of Dysport reached €84.4 million, up 4.8%, driven by the resupply following the renewal of the Good Manufacturing Practices (GMP) certificate and a strong demand in Brazil in the first quarter of 2018, a good performance in North America in the therapeutics market, partly offset by lower sales in North America to Galderma as compared to the first quarter of 2017 when there was a higher phasing of shipments. Over the period, Neuroscience sales represented 16.7% of total Group sales, compared to 19.8% in 2017.
In Rare Diseases, sales of NutropinAq reached €12.2 million, down 8.2% year-on-year, impacted by lower volumes across Europe. Sales of Increlex reached €5.9 million, growing by 14.8% year-on-year, driven by performance in the U.S. Over the period, Rare Diseases sales represented 3.6% of total Group sales, compared to 4.3% in 2017.
Consumer Healthcare sales reached €69.9 million, up 0.8% year-on-year (or up 6.4% excluding the impact of the new Etiasa contractual set up in China), driven by the performance of Tanakan and of other Consumer Healthcare products, as well as the contribution of the newly acquired OTC products (including Prontalgine and Buscopan). Over the period, Consumer Healthcare sales represented 13.7% of total Group sales, compared to 16.3% in 2017.
Smecta – Sales reached €25.4 million, down 8.5% year-on-year, due to the negative impact of inventory in the first quarter of 2017 in Russia and in China, partly compensated by higher sales in France from the new OTC formulation.
Forlax – Sales reached €10.2 million, up 4.1% year-on-year, driven by growing sales to partners.
Tanakan – Sales reached €7.8 million, up 26.9% year-on-year, positively impacted by the lower inventory in Russia in the first quarter of 2017.
Fortrans/Eziclen – Sales reached €6.0 million, down 11.6% year-on-year, impacted by the negative inventory impact and high competitive pressure in Russia, partly offset by good local performance in China.
Etiasa – Sales reached only €0.1 million, due to the new contractual set up in China which started in the third quarter of 2017.
Other Consumer Healthcare – Sales reached €3.4 million, up 12.7% year-on-year, supported by the new products Prontalgine and Buscopan.
Sales in Major Western European countries reached €182.2 million, up 17.4% year-on-year. Over the period, sales in Major Western European countries represented 35.7% of total Group sales, compared to 35.5% in 2017.
France – Sales reached €68.2 million, up 11.0% year-on-year, driven by the Cabometyx launch, the sustained growth of Somatuline, the strong sales of Decapeptyl and Smecta and the contribution of Prontalgine.
Germany – Sales reached €44.2 million, up 27.7% year-on-year, driven by the Cabometyx launch and the strong growth of Somatuline.
Italy – Sales reached €26.2 million, up 10.5% year-on-year, mainly driven by the launch of Cabometyx.
United Kingdom – Sales reached €22.5 million, up 23.5% year-on-year, driven by the strong performance of Somatuline and Cabometyx.
Spain – Sales reached €21.0 million, up 23.0% year-on-year, driven by the good performance of Somatuline and Decapeptyl, as well as the contribution of Cabometyx.
Sales in Other European countries reached €107.7 million, up 13.5% year-on-year, supported by the strong growth of Dysport, the launch of Cabometyx in certain countries, Onivyde sales to Ipsen’s partner, as well as the solid performance of Somatuline and Decapeptyl. Over the period, sales in the region represented 21.1% of total Group sales compared to 22.2% in 2017.
Sales generated in North America reached €134.4 million, up 51.1% year-on-year, driven by continued strong growth of Somatuline, the good performance of Dysport in the therapeutics market and the contribution of Onivyde. Over the period, sales in North America represented 26.3% of total Group sales, compared to 23.4% in 2017.
Sales in the Rest of the World reached €86.0 million, up 11.6% year-on-year, driven by the good performance of Dysport in Brazil and Australia, and the growth of Somatuline in certain countries. Over the period, sales in the Rest of the World represented 16.9% of total Group sales, compared to 18.9% in 2017.
MAJOR DEVELOPMENTS
During the first quarter of 2018, major developments included:
12 January 2018 – Ipsen announced the appointment of Richard Paulson as Executive Vice-President and Chief Executive Officer of Ipsen North America, responsible for all commercial operations throughout the region. He joined Ipsen from Amgen where he most recently served as Vice-President and General Manager of the Oncology Business Unit.
16 January 2018 – Ipsen and Exelixis announced detailed results of the pivotal Phase 3 CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC), were presented in a late-breaking oral session at the 2018 ASCO (Free ASCO Whitepaper)-GI Symposium being held in San Francisco, January 18-20, 2018.
26 January 2018 – Ipsen announced that Sotirios G. Stergiopoulos, MD, has been appointed as Chief Medical Officer. Dr Stergiopoulos joined Ipsen in January 2017 as Senior Vice President, Head of Global Medical Affairs (GMA) and retains this position in addition to the role as the new Chief Medical Officer within the company.
21 February 2018 – Arix Bioscience plc, a global healthcare and life science company supporting medical innovation, and Ipsen announced a strategic agreement to develop and commercialize innovative therapies.
13 March 2018 – Ipsen announced the appointment of two key executive positions in its Executive Leadership Team. Ivana Magovčević-Liebisch, Ph.D., J.D., joined as Executive Vice-President, Chief Business Officer, and Régis Mulot joined as Executive Vice-President, Chief Human Resources Officer.
23 March 2018 – Ipsen announced that the Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion for Cabometyx (cabozantinib) for the first-line treatment of adults with intermediate or poor risk advanced renal cell carcinoma (aRCC).
28 March 2018 – Ipsen announced that the European Medicines Agency (EMA) has validated the filing of a new application for an additional indication for Cabometyx, for patients with previously treated advanced Hepatocellular Carcinoma (HCC).
Conference call
Ipsen will host a conference call on Thursday 26 April 2018 at 2:30 p.m. (Paris time, GMT+1). A conference call will take place and a web conference (audio and slides) will be available at www.ipsen.com. Participants should dial in to the call approximately 5 to 10 minutes prior to its start. No reservation is required to participate in the conference call.
France and continental Europe: +33 (0)1 76 74 24 28
UK: +44 (0) 1452 555 566
US: +1 631 510 7498
Conference ID: 7769826
A recording will be available for 7 days on Ipsen’s website and at the above numbers