Regulatory News:
The Board of Directors of Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY), chaired by Marc de Garidel, met on 26 August 2011 to approve the financial statements for the first half 2011, published today. The interim financial report, with regard to regulated information, is available on the Group´s website, www.ipsen.com, under the Regulated Information tab in the Investor Relations section. The 2011 half year financial statements have been subject to a limited review by statutory auditors.
Commenting on the first half 2011 performance, Marc de Garidel, Chairman and Chief Executive Officer of Ipsen, said: "With drug sales totalling €567 million, up by 5.2% year-on-year excluding foreign exchange impacts3, Ipsen has once again seen dynamic growth in its specialty care products. This sales performance has resulted in the Group increasing its financial objectives for the full year 2011. Taking into account the strategic review and the gradual re-focusing of the Group spending, particularly on the 10 phase III clinical trials currently underway, 2011 must be viewed as a transitional year in terms of profitability." Marc de Garidel added: "Since the announcement of the new strategy on 9 June, Ipsen has been gearing up to fulfil its 2020 ambition. To this end, all the positions in the Group´s Executive Committee have now been filled and the administrative and employee-related procedures required for authorisation to close the Barcelona R&D site have been completed. In Europe, we have just entered into an agreement in hemophilia with our partner Inspiration Biopharmaceuticals to build a strong commercial presence. Lastly, in North America, we began transferring our commercial activities to the East Coast. Now that we have laid down the foundations in our vision, we will introduce in the coming months the investments announced on 9 June."
1 Growth in sales expressed excluding foreign exchange impacts
2 "Recurring adjusted": Profit adjusted by non-recurring expenses particularly linked with the preparation and the implementation of the strategy announced on 9 June 2011. A reconciliation between the operating income and the recurring adjusted operating income is attached in appendix 4.
3 Variations excluding foreign exchange impacts are computed by restating the first half 2010 with the first half 2011 average exchange rates.
Extract of consolidated results
(in million of euros) These results were subject to a limited review by the auditors | H1 2011 | H1 2010 | % change | |||
Specialty Care sales | 381.0 | 352.1 | +8.2% | |||
Primary Care sales | 185.6 | 185.6 | 0.0% | |||
Total drug sales | 566.6 | 537.8 | +5.4% | |||
Drug-related sales | 16.5 | 16.2 | +2.1% | |||
Consolidated sales | 583.1 | 553.9 | +5.3% | |||
Other revenues | 36.3 | 31.7 | +14.4% | |||
Total revenues | 619.4 | 585.7 | +5.8% | |||
Research and development expenses | (105.8) | (99.1) | +6.7% | |||
Operating income | 120.8 | 104.9 | +15.1% | |||
In % of sales | 20.7% | 18.9% | - | |||
Recurring adjusted operating income1 | 143.9 | 113.2 | +27.1% | |||
In % of sales | 24.7% | 20.4% | - | |||
Share of profit/loss from associated companies | (4.1) | (5.1) | (19.6)% | |||
Consolidated net profit (attributable to shareholders of Ipsen) | 91.7 | 75.5 | +21.4% | |||
Earnings per share "´ fully diluted (€) (attributable to shareholders of Ipsen) | 1.09 | 0.89 | +22.5% | |||
Recurring adjusted consolidated net profit1 (attributable to shareholders of Ipsen) | 107.3 | 80.7 | +33.0% | |||
Recurring adjusted earnings per share "´ fully diluted1 (€) (attributable to shareholders of Ipsen) | 1.27 | 0.96 | +32.3% | |||
Net cash flow from operating activities | 97.3 | 134.7 | ||||
1 See appendix 4. |
Review of the first half 2011 sales and results
The Group´s consolidated sales amounted to €583.1 million, up 5.3% year-on-year (+4.9% excluding foreign exchange impacts2). Sales of specialty care products totalled €381.0 million, up 8.2% year-on-year (7.9% excluding foreign exchange impacts2). Specialty care products represented 65.3% of the Group´s consolidated sales, compared with 63.6% a year earlier. Sales of primary care products totalled €185.6 million, stable year-on-year.
Drug sales grew 5.4% year-on-year (+5.2% excluding foreign exchange impacts2) mainly driven by:
- Sales of the Neurology franchise, up 18.1% (+16.9% excluding foreign exchange impacts2) thanks primarily to the increase in the sales of Dysport® in North America, the product´s performance in Latin America and to increased supply of the product to the Group´s partners, Medicis and Galderma;
- The performance of the Endocrinology franchise, up 11.5% mainly due to the Group´s presence in North America;
- The resilience of primary care drugs, supported by international sales.
2 Variations excluding foreign exchange impacts are computed by restating the first half 2010 with the first half 2011 average exchange rates
Sales in the major Western European countries in the first half 2011 totalled €273.7 million, down 3.5% year-on-year excluding foreign exchange impacts1. The dynamic growth in sales volumes of speciality care products was more than offset by the consequences of the tougher primary care environment in France and by administrative measures in Germany and Spain. In the other European countries, sales totalled €144.4 million, up 10.6% excluding foreign exchange impacts1, driven by sustained growth in volumes, particularly in Switzerland where the Group sells Azzalure® to its partner Galderma, and in Russia, Austria and Ukraine. Sales in North America totalled €33.1 million, up 25.6% excluding foreign exchange impacts1, sustained by the continuous penetration of Somatuline® in the treatment of acromegaly and the increase in the sales of Dysport® in the treatment of cervical dystonia. In the rest of the World, sales totalled €131.9 million, up 14.4% excluding foreign exchange impacts1, fuelled in particular by strong growth in volumes in Algeria, Australia, Colombia and China despite a destocking effect on Decapeptyl® related to implementation of a new distribution model in the latter country.
Other revenues amounted to €36.3 million in the first half 2011, up 14.4% compared with €31.7 million the previous year. This growth is linked to the increased royalties paid by Medicis, Galderma and Menarini, and to the rebilling of OBI-1 industrial development expenses related to the agreements signed with Inspiration Biopharmaceuticals Inc..
Consequently, total revenues totalled €619.4 million in the first half 2011, up 5.8% year-on-year.
R&D expenses totalled €105.8 million in the first half 2011, up 6.7% year-on-year. Excluding industrial development expenses for OBI-1, billed to Inspiration Biopharmaceuticals Inc., research and development expenses accounted for 16.7% of sales, up 5.6% year-on-year, excluding foreign exchange impacts1.
Selling, general and administrative expenses amounted to €248.2 million in the first half 2011, almost stable year-on-year, reflecting the Group´s selective commercial resources allocation policy to growth geographies.
In the first half 2011, the Group posted a non-recurring income of €17.2 million in other operating income and expenses following the enforceable ruling handed down in relation to the commercial dispute between the Group and Mylan. This income was partially offset by non-recurring expenses linked to implementation of the strategy announced on 9 June 2011.
With regard to implementation of the new strategy, the Group posted €28.1 million of non-recurring costs for restructuring, mainly corresponding to the closure of the Research and Development centre at the Barcelona (Spain) site and to the transfer of the Group´s North-American commercial subsidiary to the East coast.
Consequently, operating income totalled €120.8 million in the first half 2011, up 15.1% compared with June 2010, and accounted for 20.7% of sales, compared with 18.9% in the previous year. Excluding certain non-recurring costs, linked this year to the implementation of the Group´s new strategy and excluding the effects in the two periods of the allocation of goodwill from the Group´s transactions in North America, recurring adjusted operating income2 at 30 June 2011 amounted to €143.9 in the first half 2011, or 24.7% of sales compared to 20.4% the previous year, and up 27.1% year-on-year.
At 30 June 2011 the Group posted a share in the loss of associated companies of €(4.1) million, consisting of its share in the loss of the company Inspiration Biopharmaceuticals Inc., which has been accounted for using the equity method since January 2010.
1 Variations excluding foreign exchange impacts are computed by restating the first half 2010 with the first half 2011 average exchange rates
2 See appendix 4.
Consolidated net profit (attributable to shareholders of Ipsen) amounted to €91.7 million compared with €75.5 million the previous year. Excluding certain non-recurring costs, linked this year to the implementation of the Group´s new strategy and excluding accounting consequences linked to the allocation of goodwill from the Group´s transactions in North America, recurring adjusted1 profit diluted per share (attributable to shareholders of Ipsen) amounted to €1.27, a sharp rise of 32.3% year-on-year.
At 30 June 2011, the total of milestones received in cash and not yet recognised in the consolidated income statement amounted to €206.1 million, down 26.6% compared with €280.6 million recorded the previous year. In the first half 2010, the Group notably posted €53.1 million of deferred revenue for its partnerships with Menarini and Inspiration Biopharmaceuticals Inc..
Net cash flow from operating activities represented €97.3 million, compared with €134.7 million in the previous year. In 2010, the Group received significant cash payments in relation to its partnerships. At 30 June 2011, the Group had a positive closing net cash and cash equivalents of €155.0 million, down by €9.1 million compared with 30 June 2010.
Update of 2011 financial targets
Based on information currently available and given its solid performance in the first half 2011, the Group is now targeting for the full year 2011:
- Specialty Care drug sales growth close to 8.0% year-on-year
- Primary Care drug sales decrease of 3.0% to 5.0% year-on-year
- A recurring adjusted1 operating income ranging from 190 million euros to 200 million euros
The above objectives are set excluding any foreign exchange impacts.
1 "Recurring adjusted": before non-recurring expenses particularly linked with the preparation and the implementation of the strategy announced on 9 June 2011. A reconciliation between the operating income and the recurring adjusted operating income is attached in appendix 4.
Ipsen - Media conference call (in French)
Ipsen will host a conference call on Tuesday 30 August 2011 at 9:30 am (Paris time - GMT+1).
Participants in the conference call may connect for the meeting 5-10 minutes prior to its start. No reservations are required to participate. The access code is 90862774. The telephone number to call in order to connect to the conference call from France is 0805 110 480, from other countries in Europe it is +44 (0) 1452 568 328 and from the United States +1 866 261 3627. The telephone number to call in order to access a recording of the conference call from France is 0805 111 337, from other countries in Europe it is +44 (0) 1452 55 00 00, from the United States +1 866 247 4222. The access code is 90862774#. The conference call is available for one week following the meeting.
Webcast and Conference Call (in English) for financial analysts and journalists
Ipsen will host a web conference (webcast & video) and conference call on Tuesday, August 30, 2011 at 2:00 pm (Paris time - GMT+1). The webcast will be available live at: www.ipsen.com
Participants in the conference call may connect for the meeting 5-10 minutes prior to its start. No reservations are required to participate. The conference ID is 899925. The telephone number to call in order to connect to the conference call from France is +33 (0) 1 70 99 32 08, from the UK is +44 (0) 207 162 0077 and from the United States +1 334 323 6201. The telephone number to call in order to access a recording of the conference call from France is +33 (0) 1 70 99 35 29, from the UK is +44 (0) 207 031 4064 and from the United States +1 954 334 03 42. The access code is 899925. The conference call and webcast will be available for one week following the meeting.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.1 billion in 2010. Ipsen´s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by four franchises: neurology / Dysport®, endocrinology / Somatuline®, uro-oncology / Decapeptyl® and hemophilia. Moreover, the Group has an active policy of partnerships. R&D is focused on innovative and differentiated technological patient-driven platforms, peptides and toxins. In 2010, R&D expenditure totaled more than €220 million, above 20% of Group sales. The Group has total worldwide staff of close to 4,500 employees. 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.
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 Generics that might translate into loose of market shares.
Furthermore, the Research and Development process involves several stages each of which involve 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. 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 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.
APPENDICES
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 2010 Registration Document available on its website (www.ipsen.com).
- The Group is dependent on the setting of prices for medicines and is vulnerable to the possible reduction of prices of certain of its products by public or private payers or to their possible withdrawal from the list of reimbursable products by the relevant regulatory authorities in the countries where it does business. In general terms, the Group is faced with uncertainty in relation to the prices set for all its products, in so far as medication prices have come under severe pressure over the last few years as a result of various factors, including the tendency for governments and private payers to reduce prices or reimbursement rates for certain drugs marketed by the Group in the countries in which it operates, or even to remove those drugs from lists of reimbursable drugs. For example, the reimbursement rate of Ginkor Fort® in France was lowered from 35% to 15%. The product was finally withdrawn from the list of reimbursable drugs on 1 January 2008. At the same time, Ipsen sold its Ginkor Fort® marketing licences for France, Monaco and Andorra to the GTF Group with effect from 1 January 2008. Ginkor Fort® generated sales of €9.6 million in France in 2010, while in France in 2007, Ginkor Fort® generated €34.1 million. The reimbursement rate for drugs with a low or insufficient therapeutic value (Service Médical Rendu Faible ou Insuffisant), including Tanakan® was lowered to 15% on 1 April 2010. Additionally, on January 15th 2011, the French Health Minister announced a set of new rules on drugs with an insufficient therapeutic value (Service Médical Rendu Insuffisant) that include Tanakan®: "In the absence of specific notice from the Health Minister, the social security will no longer reimburse this class of drugs";
- The Group depends on third parties to develop and market some of its products which generate or may generate substantial royalties for the Group, but these third parties could behave in ways which cause damage to the Group´s business. The Group cannot be certain that its partners will fulfill 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.
- Actual results may depart significantly from the objectives given that a new product can appear to be promising at a development stage or after clinical trials but never be launched on the market or be launched on the market but fail to sell notably for regulatory or competitive reasons;
- The Research and Development process typically lasts between eight and twelve years from the date of a discovery to a product being brought to market. This process involves several stages; at each stage, there is a substantial risk that the Group could fail to achieve its objectives and be forced to abandon its efforts in respect of products in which it has invested significant amounts. Thus, in order to develop viable products from a commercial point of view, the Group must demonstrate, by means of pre-clinical and clinical trials, that the molecules in question are effective and are not harmful to humans. The Group cannot be certain that favourable results obtained during pre-clinical trials will subsequently be confirmed during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safety and efficacy of the product in question such that the required marketing approvals can be obtained;
- The Group must deal with or may have to deal with competition (i) from generic products, particularly in relation to Group products which are not protected by patents, for example, Forlax® or Smecta® (ii), products which, although they are not strictly identical to the Group´s products or which have not demonstrated their bioequivalence, may obtain a marketing authorisation for indications similar to those of the Group´s products pursuant to the bibliographic reference regulatory procedure (well established medicinal use) before the patents protecting its products expire. Such a situation could result to the Group losing market share which could affect its current level of growth in sales or profitability;
- Third parties might claim the benefit of intellectual property rights in respect to the Group´s inventions. The Group provides the third parties with which it collaborates (including universities and other public or private entities) with information and data in various forms relating to the research, development, manufacturing and marketing of its products;
Despite the precautions taken by the Group with regard to these entities, in particular of a contractual nature, they (or certain of their members or affiliates) could claim ownership of intellectual property rights arising from the trials carried out by their employees or any other intellectual property right relating to the Group´s products or molecules in development;
- The Group´s strategy includes acquiring companies or assets which may enable or facilitate access to new markets, research projects or geographical regions or enable it to realise synergies with its existing businesses. Should the growth prospects or earnings potential of such assets as well as valuation assumptions change materially from initial assumptions, the Group might be under the obligation to adjust the values of these assets in its balance sheet, thereby negatively impacting its results and financial situation;
- The marketing of certain products by the Group has been and could be affected by supply shortages and other disruptions. Such difficulties may be of both a regulatory nature (the need to correct certain technical problems in order to bring production sites into compliance with applicable regulations) and a technical nature (difficulties in obtaining supplies of satisfactory quality or difficulties in manufacturing active ingredients or drugs complying with their technical specifications on a sufficiently reliable and uniform basis). This situation may result in inventory shortages and/or in a significant reduction in the sales of one or more products;
- In certain countries exposed to significant public deficits, and where it sells its drugs directly to public hospitals, the Group could experience discount or lengthened payment terms or difficulties in recovering its receivables in full. In Greece notably, which represented in 2010 approximately 1.5% of its consolidated sales, and where payment terms from public hospitals are particularly long, the Group is closely monitoring the current situation. More generally, the Group may also be unable to purchase sufficient credit insurance to protect itself adequately against the risk of payment default from certain customers worldwide. Such situations could negatively impact the Group´s activities, financial situation and results;
- In the normal course of business, the Group is or may be involved in legal or administrative proceedings. Financial claims are or may be brought against the Group in connection with some of these proceedings;
- The implementation of the strategy has to be submitted to the relevant staff representation authorities in each country concerned, in compliance with the specific procedures, terms and conditions set forth by each national legislation.
- In France, the government presented at the Council of Ministers on August 1 a bill on enhancing drug safety. This reform has three main parts: transparency and management of links of interest for experts, governance of health products and measures on the drug (including restrictions of company rep visits to hospitals and new regulation of Named Patient Basis "ATU"). Other measures announced by the Minister for Work, Employment and Health but not in this bill, should also be decided, such as a new tax for drug companies to fund continuing medical education for physicians.
Major developments in the first half 2011
- On February 2, 2011 - Ipsen announced that Roche informed it on its decision to return taspoglutide to Ipsen. Roche´s decision is based on the analysed data stemming from the root cause analysis carried-out on both nausea and hypersensitivity. According to the agreements signed with Roche in 2003 and 2006, Ipsen is entitled to the full body of data generated by Roche. Ipsen will thouroughly assess the available data to determine potential further partnership opportunities. Given the level of required investment, Ipsen does not intend to clinically develop taspoglutide on its own.
- On February 3, 2011 "´ Ipsen announced that its partner Inspiration Biopharmaceuticals Inc. (Inspiration) presented pharmacokinetic (PK) data on its lead product, IB1001, a recombinant factor IX (FIX) for the treatment and the prevention of bleeding in individuals with hemophilia B. According to Inspiration, results of the Phase I portion of an ongoing IB1001 clinical study demonstrated non-inferiority of IB1001 in achieving overall levels of replacement facto compared to BeneFIX®, the only approved recombinant FIX product for the treatment of hemophilia B. Currently, IB1001 is in Phase III and safety and efficacy results are expected later this year.
- On February 25, 2011 - Ipsen and bioMérieux announced that they have entered into a partnership to create a global collaboration in theranostics, with a focus on hormone-dependent cancers. The two companies have signed a framework agreement to leverage their expertise and resources to develop a personalized approach to medicine based on Ipsen´s broad portfolio of innovative compounds and bioMérieux´s diagnostic tests.
- On March 2, 2011 "´ GTx announced that a decision has been taken with its European partner Ipsen to terminate their agreement on the development of toremifene citrate for the reduction of fractures in men with advanced prostate cancer on androgen deprivation therapy.
- On 9 March 2011 "´ Ipsen announced that the Food and Drug Administration (FDA) has approved Ipsen´s Prior Approval Supplement application for the Extended Dosing Interval of Somatuline® Depot for patients suffering from acromegaly.
- On 18 April 2011 "´ The Group and Active Biotech announced the signature of a partnership agreement to co-develop and commercialize Tasquinimod "TASQ". A phase III clinical trial in men with metastatic castrate-resistant prostate cancer has recently been initiated by Active Biotech and patient recruitment is ongoing. Under the terms of the contract, Active Biotech grants to Ipsen exclusive rights to commercialize TASQ worldwide, except for North America, South America and Japan, where Active Biotech retains all commercial and marketing rights. Both companies will co-develop TASQ for the treatment of castrate-resistant prostate cancer, with the possibility to develop TASQ in other cancer indications. Active Biotech is responsible for conducting and financing the Phase III pivotal clinical trial and will receive up to €200 million consisting of an upfront payment of €25 million and additional payments contingent upon achievement of clinical, regulatory and commercial milestones. In addition, Ipsen will pay Active Biotech double-digit progressive royalties on its net sales and will conduct and fund a European supportive study in prostate cancer patients out of its R&D budget. Eventual costs to develop TASQ in future other cancer indications will be shared.
- On 28 April 2011 "´ The Paris Court of Appeal invalidated the Paris Commercial Court decision of 24 January 2008 relating to the commercialisation of Vitalogink®, and in favour of the arguments put forward by the Group. The Court ordered Mylan to pay Ipsen €17.2 million in compensation for losses incurred. On 7 July 2011 - Mylan announced that it has submitted an appeal against this decision to the Supreme Court.
- On 2 May 2011 "´ Ipsen announced the departures of Frédéric Babin, Executive Vice-President Human Resources, and Stéphane Thiroloix, Executive Vice-President-Corporate Development.
- On 11 May 2011 "´ Ipsen announced the appointment of Etienne de Blois as Executive Vice-President Human Resources, member of the Group´s Executive Committee.
- On 27 May 2011 "´ Ipsen announced the departure of Claire Giraut, Executive Vice-President, Chief Financial Officier, as of 1 September 2011.
- On 6 June 2011 "´ Ipsen announced its decision to stop the development of Irosustat (BN 83495) in monotherapy and to assess its alternative development in combination with other hormonal therapies. This decision is based on the futility analysis from the proof-of-concept trial phase II clinical study carried out in Europe in monotherapy in endometrial cancer, and on the phase I/II clinical study results obtained in metastatic prostate and breast cancers.
- On 9 June 2011 "´ Ipsen announced the appointment of Pierre Boulud as Executive Vice-President, Strategy, Business Development and Market Access, member of the Group´s Executive Committee.
- On 9 June 2011 "´ Ipsen announced its new strategy based on three major pillars: Increase focus, Invest to grow and Leverage footprint
After 30 June 2011, major developments included:
- On 12 July 2011 - Ipsen and the Salk Institute for Biological Studies announced that they are renewing the Ipsen Life Sciences Program at the Salk Institute. The mission of the partnership is to advance knowledge in the field of proliferative and degenerative diseases through fundamental and applied biology research.
- On 12 July 2011 "´ Ipsen and Institut de cancérologie Gustave Roussy (IGR, Villejuif), announced the signature of a partnership in the area of medical oncology to leverage the combined expertises of their respective R&D teams. This 3 year agreement was signed on 27 June 2011.
- On 28 July 2011 - Ipsen announced that its partner Inspiration Biopharmaceuticals presented data from its clinical development program for OBI-1, a recombinant porcine factor VIII product (rpFVIII), intended for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia. A total of three patients with acquired hemophilia, who had experienced severe bleeds not controlled with by-passing agents, were treated with OBI-1; in all three patients, treatment with OBI-1 stopped the bleeding.
Administrative measures
European governments continued introducing various measures targeting the reduction of public health expenses.
In a context of financial and economic crisis, the governments of many countries in which the Group operates continue to introduce new measures to reduce public health expenses, some of which have affected Group sales and profitability in the first half 2011. In addition, certain measures introduced in 2010 have continued to affect the Group´s accounts year-on-year.
- After introducing an 8% tax on drug sales, Romania has announced a reform wherein the new tax would be based on the growth in sales of the entire portfolio of reimbursed products (a portion paid by the State) since 2009.
- In 2010, the Czech Republic announced its intention to limit the reimbursement level of different therapeutic classes to the lowest levels of the same therapeutic classes in Europe, which could lead to price reductions in the order of 20% (voted measure, implementation pending); the setting-up of reverse electronic calls for bids and the reinforcement of reimbursement rules for innovative products are also on the agenda.
- In early 2011, Ireland announced an austerity plan, including measures relating to public health expenses.
- In addition to the 7.5% tax on drug sales since June 2010, Spain introduced a price reduction by 30% for products which have a generic or a biosimilar product marketed in at least on of the European countries.
- In 2011 Portugal has introduced an electronic system encouraging the prescription of the cheapest product (including generics).
- In late 2010 Belgium increased the price reduction percentage applicable to certain products from 12% to 15% for products which have been on the market for more than 12 years, and from 15% to 19% for products which have been on the market for more than 15 years.
- The Baltic States have introduced price/volume agreements based on the growth of the State budget, in November 2010 for Lithuania and beginning of 2011 for Latvia.
Furthermore, and still in the financial and economic crisis context, governments of many countries in which the Group operates continue to introduce new measures to reduce public health expenses, some of which may affect the Group sales and profitability beyond the first half 2011.
- Hungary has doubled the health visitor tax, taking it to €40 thousand per year, and increased the tax on sales from 12% to 20%.
- As of November 1st, 2011, Spain will raise its tax on drug sales from 7.5% to 15.0% from products that have been on the market for more than 10 years.
- On August 4, 2011 China announced an average retail price decrease of 14% on 82 drugs primarily targeting steroid, endocrine and central nervous system therapeutics. This price cut will be effective on September 1st, 2011.
Governments of many countries in which the Group operates continue to consider or implement new or additional measures.
Comparison of consolidated sales for the second quarters and first halves 2011 and 2010:
Sales by geographical area
For the second quarters and first halves 2011 and 2010, the Group sales by geographical region were as follows:
2nd quarter | 1st half | |||||||||||||
(in million of euros) | 2011 | 2010 | % Change | 2011 | 2010 | % Change | % Change at constant currency1 | |||||||
France | 80.3 | 85.7 | -6.3% | 149.5 | 161.4 | -7.4% | -7.4% | |||||||
United Kingdom | 10.3 | 10.9 | -5.4% | 21.4 | 21.0 | 2.2% | 1.6% | |||||||
Spain | 15.4 | 14.7 | 5.1% | 31.0 | 30.5 | 1.7% | 1.7% | |||||||
Germany | 14.8 | 14.0 | 5.9% | 29.6 | 30.5 | -2.9% | -2.9% | |||||||
Italy | 20.9 | 19.9 | 5.4% | 42.2 | 40.1 | 5.3% | 5.3% | |||||||
Major Western European countries | 141.7 | 145.0 | -2.3% | 273.7 | 283.4 | -3.4% | -3.5% | |||||||
Eastern Europe | 32.9 | 34.6 | -5.0% | 77.0 | 71.6 | 7.5% | 7.5% | |||||||
Other European countries | 34.4 | 28.6 | 20.0% | 67.4 | 57.3 | 17.7% | 14.3% | |||||||
Other European countries | 67.3 | 63.2 | 6.4% | 144.4 | 128.9 | 12.1% | 10.6% | |||||||
North America | 16.4 | 17.6 | -6.7% | 33.1 | 27.5 | 20.3% | 25.6% | |||||||
Asia | 38.0 | 33.1 | 14.7% | 65.6 | 60.8 | 7.9% | 8.3% | |||||||
Other rest of the world | 33.9 | 28.7 | 18.0% | 66.3 | 53.4 | 24.2% | 21.2% | |||||||
Rest of the world | 71.9 | 61.8 | 16.2% | 131.9 | 114.2 | 15.5% | 14.4% | |||||||
Group Sales | 297.3 | 287.7 | 3.3% | 583.1 | 553.9 | 5.3% | 4.9%
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idVisited.unshift(idNoticia);
document.cookie = "ee_idVisited="+JSON.stringify(idVisited)+"; expires="+cookie_now.toUTCString()+"; domain=.eleconomista.es; path=/";
}
} else {
let idVisited = [idNoticia];
document.cookie = "ee_idVisited=" + JSON.stringify(idVisited) +"; expires="+cookie_now.toUTCString()+"; domain=.eleconomista.es; path=/";
}
}
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