[February 27, 2013] |
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Ipsen's 2012 Results and 2013 Financial Objectives
PARIS --(Business Wire)--
Regulatory News:
The Board of Directors of Ipsen (Euronext: IPN; ADR: IPSEY) (Paris:IPN),
chaired by Marc de Garidel, met on 26 February 2013 to review the
Group's results for 2012, published today. The annual financial report,
with regards to the regulated information, will be available on the
Group's website, www.ipsen.com,
Investor Relations section.
Extract from audited consolidated results for 2012 and 2011 (in
million euros)
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2012
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2011 Proforma3
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% change
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Drug sales
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1 187.0
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1 127.9
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+5.2%
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Sales
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1 219.5
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1 159.8
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+5.1%
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Total revenues
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1 277.4
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1 210.2
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+5.6%
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Operating profit
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114.8
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72.6
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+58.2%
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Operating margin2
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9.4%
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6.3%
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-
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Recurring adjusted1 operating profit
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196.0
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197.5
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(0.8%)
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Recurring adjusted1 operating margin2
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16.1%
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17.0%
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Consolidated profit
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(29.0)
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0.9
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Earnings per share - fully diluted (€)
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(0.35)
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0.01
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Recurring adjusted1 consolidated profit
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145.5
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154.4
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(5.8%)
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Recurring adjusted1 EPS - fully diluted
(€)
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1.74
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1.85
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(5.9%)
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Weighted average number of shares:
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Outstanding
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83 155 604
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83 217 638
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(0.07%)
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Fully diluted
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83 460 232
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83 465 467
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(0.01%)
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Commenting the 2012 performance, Marc de Garidel, Chairman and Chief
Executive Officer of Ipsen, stated: « 2012 results
highlight the Group's resilience, with both sales and profitability
objectives beaten in the context of a challenging French primary care
environment, showing a 30% sales decline year-on-year. » Marc de
Garidel added: « 2013 will be marked by the implementation of a
new French primary care commercial operations organization and the
publication of crucial clinical data. On a different note, I am pleased
to announce the appointment of Christel Bories as Deputy Chief Executive
Officer. Christel will help us accelerate the execution of the Group
strategy. »
1 « Recurring adjusted »: Reconciliations between results and
recurring adjusted results for 2012 and 2011 are detailed in appendix 4 2
In percentage of sales 3 In compliance with provisions
on "discontinued activities", 2011 figures have been restated to provide
comparative information between 2011 and 2012 (see appendix 5)
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Comparison between the Group's 2012 performance and its
financial objectives
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Financial objectives4
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2012 actuals
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Specialty Care drug sales growth
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Around 10.0%
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+11.3%
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Primary Care drug sales growth
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Approximately -15.0%
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-13.2%
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Recurring adjusted5
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Approximately 15.0% of sales
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16.1% of sales
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Review of full year 2012 results
Note: Comparisons are made on a proforma basis with all income and
expense related to Inspiration recorded in discontinued operations
In 2012, Group drug sales grew 3.4% year-on-year excluding
foreign exchange impact1, fuelled notably by the dynamic
growth of specialty care sales.
Consolidated Group sales reached €1,219.5 million in 2012, up
3.3% year-on-year excluding foreign exchange impact1.
Other revenues reached €57.9 million in 2012, up 14.9%
year-on-year. In 2012, the Group recorded a revenue of €20.9 million,
against €17.8 million the previous year, related to the Group's
co-promotion and co-marketing agreements in France as well as promotion
of Hexvix® in some countries. Royalties received amounted to
€11.9 million in 2012, up 30.9% year-on-year, driven by the increase in
royalties paid by the Group's partners.
Total revenues amounted to €1,277.4 million, up 5.6% compared
with 2011.
Cost of goods sold amounted to €254.8 million, or 20.9% of sales,
against 21.5% in 2011. The cost of goods sold, positively impacted by
the favourable mix related to the growth in specialty care sales and the
Group's productivity efforts, was partially offset by custom duties in
high growth countries.
Research and Development expenses reached €248.6 million in 2012,
up 5.9% year-on-year, mainly driven by the major programmes conducted
during the period on Dysport®, Somatuline® and
tasquinimod. Increase of Research and Development drug-related costs was
partially offset by a favourable comparison basis: costs related to the
phase II clinical study of Irosustat (BN-83495) were no longer recorded
in 2012 as the program was discontinued on 6 June 2011. Moreover,
industrial and pharmaceutical development expenses grew by 14.9% in
2012, mainly resulting from investments in the Group's toxins and
peptides technology platforms.
Selling, general and administrative expenses amounted to
€572.6 million at 31 December 2012, or 46.9% of sales, up 9.3%
year-on-year. In line with the strategy announced on 9 June 2011, the
Group continued to increase commercial investments in specialty care
while selectively allocating business resources to high growth areas
mainly China, Russia and Brazil. Furthermore, selling expenses related
to primary care in France increased proportionally to declining sales.
Synergies from the new organization of French primary care commercial
operations are expected to materialize in 2014.
1 Sales growth excluding foreign exchange impacts. Variations
excluding foreign exchange impacts are computed by restating the 2011
figures with the 2012 average exchange rates 2
« Recurring adjusted »: Reconciliations between results and recurring
adjusted results for 2012 and 2011 are detailed in appendix 4
Reported operating income in 2012 reached €114.8 million,
up 58.2% year-on-year, notably affected by:
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Other operating expenses of €25.8 million, mainly comprising
non-recurring costs resulting from the search for potential acquirers
for the Dreux industrial site and partners for the primary care
commercial activity in France, the settlement of a trade dispute with
a partner and an administrative procedure involving the Group.
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Amortisation of intangible assets (excluding software), a charge
of €5.8 million, compared to €7.8 million the previous year. This
decrease is mainly due to the change in the amortization plan of IGF-1
following the impairment loss recorded on 31 December 2011 and to the
total amortization of Exforge® (end of co-promotion
contract in France with Novartis effective since 30 April 2012). This
decrease was partially offset by initiation of the amortization of
Hexvix®.
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Restructuring costs of €63.1 million, mainly related to the
implementation of the new organization of French primary care
commercial operations and to the transfer to the East coast of the
Group's North American commercial subsidiary that occurred between
June 2011 and June 2012.
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Impairment losses representing a non-recurring revenue of €2.4
million. Following the announcement to retain the Dreux-based
industrial facility within its scope of activity, the Group reassessed
the value of this asset and recorded an impairment write-back of €12.5
million in its consolidated financial statements as of 30 June 2012.
The Group recorded a €10.1 million impairment charge on the brand of
Nisis®/Nisisco®, following a step-up in July
2012 in France in the regulation known as « Tiers-Payant », whereby
the patient now pays upfront for a branded drug and is later
reimbursed. This has generated an unprecedented increase in generic
penetration in France.
Excluding purchase price allocation impacts, non-recurring impairment
charges and restructuring costs, the Group's recurring adjusted6
operating income amounted to €196.0 million in 2012, or 16.1%
of sales, down 0.8% year-on-year.
The effective tax rate amounted in 2012 to 20.3% of profit from
continuing activities before tax. Excluding non-recurring operating,
financing and tax items, the effective tax rate amounted to 23.2% in
2012 compared to 19.3% in 2011.
Net profit from continuing operations amounted to €95.8 million
as of 31 December 2012, up 29.9% compared to €73.8 million in 2011.
Consolidated net profit in 2012 was a loss of €29.0 million
(attributable to shareholders of Ipsen S.A.: (€29.5) million) compared
with a profit of €0.9 million in 2011 (attributable to shareholders of
Ipsen S.A.: €0.4 million). 2012 consolidated net profit was notably
affected by:
Profit from discontinued operations: a loss of €124.8 million as
of 31 December 2012, compared to a loss of €72.9 million in 2011,
composed of activities related to Inspiration:
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a non-recurring impairment charge of €100 million after tax on
tangible, intangible and financial assets;
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receivables related to the OBI-1 development costs for the second and
third quarters 2012;
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rebilling of the costs associated with the implementation of the
European platform;
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share of loss in Inspiration's result over the period before
classification as "discontinued operations";
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all of the above, partially offset by acceleration of recognition of
hemophilia related deferred revenues.
1 « Recurring adjusted »: Reconciliations between results and
recurring adjusted results for 2012 and 2011 are detailed in appendix 4
The Recurring adjusted1 consolidated net
profit amounted to €145.5 million at 31 December 2012, down 5.8%
compared with €154.4 million in 2011.
Net cash generated by operating activities (continuing operations) amounted
to €165.0 million in 2012, slightly down year-on-year. At 31 December
2012, the net cash position7 stood at €113.3
million, compared with a net cash position of €144.8 million a year
earlier, notably affected by the Group's active partnership policy:
Inspiration, Active Biotech for tasquinimod and Photocure for Hexvix®.
Dividend for the 2012 financial year proposed
for the approval of Ipsen's shareholders
Ipsen's Board of Directors, which met on 26 February 2013, has decided
to propose at Ipsen's annual shareholders' meeting to be held on 31 May
2013 the payment of a dividend of €0.80 per share, stable year-on-year,
representing a pay-out ratio of approximately 46% of recurring adjusted8
consolidated net profit (attributable to the Group's shareholders),
compared to a pay-out ratio of approximately 47% for the 2011 financial
year.
Financial objectives for 2013
Based on information currently available, the Group has set the
following financial targets for 2013:
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Specialty Care drug sales growth year-on-year between 6.0%
and 8.0%, driven by continued and solid volume growth, in a
context of increased pricing pressure and uncertainty as of today on
Increlex® supply.
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Primary Care drug sales decrease year-on-year between -8.0%
and -6.0%, with French activity to remain under pressure
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Recurring adjusted2 operating margin
around 16.0% of sales. The Group expects a continued decrease of
French primary care margin in 2013. Synergies from the new
organization of French primary care commercial operations are expected
to materialize in 2014.
The above sales objectives are set excluding foreign exchange impacts.
1 Net cash and cash equivalents: Cash and cash equivalents
after deduction of bank overdrafts, short-term bank borrowings, other
financial liabilities plus or minus derivative financial instruments. 2
« Recurring adjusted »: Reconciliations between results and recurring
adjusted results for 2012 and 2011 are detailed in appendix 4
Press conference (in French)
Ipsen will host a press conference on Wednesday 27 February 2013 at
11:30 a.m. (Paris time, GMT +1) at Pavillon Kléber - 7 rue Cimarosa -
75116 Paris (France).
Meeting, webcast and Conference Call (in English) for the financial
community
Ipsen will host an analyst meeting on Wednesday 27 February 2013 at 8:30
a.m. (Paris time, GMT+1) at its headquarters in Boulogne-Billancourt
(France). A web conference (audio and video webcast) and conference call
will take place simultaneously. The web conference will be available at www.ipsen.com.
Participants in the conference call should dial in approximately 5 to 10
minutes prior to its start. No reservation is required to participate.
The conference ID 929339. Phone numbers to call in order to
connect to the conference are: from France and continental Europe +33
(0) 1 70 99 32 08, from UK +44 (0) 20 7162 0077 and from the United
States +1 334 323 6201. No access code is required. A recording will be
available shortly after the call. Phone numbers to access the replay of
the conference are: from France and continental Europe +33 (0) 1 70 99
35 29, from UK +44 (0) 20 7031 4064 and from the United States +1 954
334 0342 and access code is 929339. This replay will be available for
one week following the meeting.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.2 billion in 2012. 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 / Dysport®, endocrinology / Somatuline®
and uro-oncology / Decapeptyl®. 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. In
2012, R&D expenditure totaled close to €250 million, representing more
than 20% of Group sales. The Group has close to 4,900 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.
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 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. 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.
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 2011
Registration Document available on its website www.ipsen.com
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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.
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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. More specifically and on the basis of
available information, according to the auction procedure under the
supervision of the US Federal Bankruptcy Court for the common sale of
Ipsen's and Inspiration's assets, the Group has impaired
haemophilia-related assets (mainly composed of the convertible bonds
and the Milford manufacturing site) for a total amount, as of 31
December 2012, of €100 million after tax. (Excluding DIP financing,
fully covered by the upfront payment in the deal recently announced
with Baxter).
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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.
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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 favorable 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.
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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 authorization 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.
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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.
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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 realize 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.
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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. More
specifically, in their US Hopkinton facility, Lonza, our supplier of
IGF-1 (Increlex® drug substance), is facing a regulatory
challenge by the Food and Drug Administration that may result in a
supply shortage in the US and in Europe.
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In certain countries exposed to significant public deficits, and where
it sells its drugs directly to public hospitals, the Group could face
discount or lengthened payment terms or difficulties in recovering its
receivables in full. In Greece notably, which represented in 2011
approximately 1.6% of 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.
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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. Ipsen Pharmaceuticals, Inc. has received an
administrative demand from the United States Attorney's Office for the
Northern District of Georgia seeking documents relating to its sales
and marketing of Dysport® (abobotulinumtoxinA) for
therapeutic use. Ipsen's policy is to fully comply with all applicable
laws, rules and regulations. Ipsen is cooperating with the U.S.
Attorney's Office in responding to the government's administrative
demand. Additionally, In February 2012, Allergan has commenced legal
proceedings against Ipsen in Italy and in the United Kingdom
concerning an alleged patent infringement. The patents claim certain
therapeutic uses of botulinum toxin products in the field of urology.
Ipsen will vigorously defend its rights in these legal proceedings,
which are based on patents that are being challenged by Ipsen in
opposition proceedings before the European Patent Office.
Major developments in 2012
In 2012, major developments included:
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On January 5, 2012 - Oncodesign, a Drug Discovery company and
Oncology pharmacology service provider, and Ipsen announced that the
two companies have entered into a research collaboration to discover
and develop innovative LRRK2 kinase inhibitors as potential
therapeutic agents against Parkinson's disease and for potential
additional uses in other therapeutic areas.
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On January 24, 2012 - Santhera Pharmaceuticals and Ipsen announced
that they had renegotiated their fipamezole licensing agreement.
Santhera regains the worldwide rights to the development and
commercialization of fipamezole, its first-in-class selective
adrenergic alpha-2 receptor antagonist for the management of
levodopa-induced Dyskinesia in Parkinson's disease. Under the
renegotiated terms, Ipsen returns its rights for territories outside
of North America and Japan in exchange for milestone payments and
royalties based on future partnering and commercial success of
fipamezole. Ipsen retains a call option for worldwide license to the
program under certain conditions.
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On January 27, 2012 - Ipsen acknowledged the French government's
decision to no longer reimburse Tanakan®, Tramisal®
and Ginkogink®. This decision is linked to the French
policy to reassess the reimbursement of a certain number of drugs by
the French Social Security. Although Tanakan®, Tramisal®
and Ginkogink® have been delisted from 1st March 2012
onwards, they can continue to be prescribed and delivered by
healthcare professionals to patients in France. The Group plans a
decrease of Tanakan® sales of around 35% in France in 2012.
This estimate is based on decreases of sales following the delisting
of veintonics in 2008.
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On February 24, 2012 - Active Biotech's and Ipsen's castrate resistant
prostate cancer project, TASQ, announced the presentation of the up to
three years safety data from the TASQ Phase II study in
chemotherapy-naïve metastatic castrate resistant prostate cancer
(CRPC) at the 27th Annual EAU Congress.
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On April 17, 2012 - Ipsen announced that its partner, Inspiration
Biopharmaceuticals, Inc. (Inspiration), has submitted a Biologics
License Application to the U.S. Food and Drug Administration (FDA) for
the approval of IB1001, an intravenous recombinant factor IX (rFIX)
for the treatment and prevention of bleeding in individuals with
hemophilia B. Under the terms of this partnership and following the
filing, Ipsen decided to pay Inspiration a $35 million milestone
payment. In return, Inspiration has issued a convertible note to
Ipsen, bringing Ipsen's fully diluted equity ownership position in
Inspiration to approximately 43.5%.
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On April 25, 2012 - Ipsen announced the official opening of its new US
commercial headquarters in Basking Ridge, New Jersey. This is an
important step forward for Ipsen in the United States. This
announcement confirms Ipsen's commitment to growth for its uniquely
targeted neurology and endocrinology therapeutics in the United States
and to provide innovative specialty medicines to US patients in need.
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On May 3, 2012 - Ipsen disclosed that it had sold, under a share
purchase agreement, all of its shares in Spirogen Limited (19.31% of
Spirogen's equity) on February 24, 2012, and is no longer represented
on the board of Spirogen. Ipsen received an upfront cash payment and
may receive deferred consideration.
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On May 3, 2012 - Ipsen disclosed that it had terminated its agreement
with Novartis for the co-promotion of Exforge® in France
effective April 30, 2012. Ipsen will receive a contractual cash exit
fee payment of €4 million from Novartis.
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On May 18, 2012 - Active Biotech and Ipsen announced the presentation
of overall survival (OS) data from the Phase II study on tasquinimod
(TASQ), their prostate cancer drug candidate (CRPC), at the scientific
conference "2012 ASCO Annual Meeting" held in Chicago (USA) on 1-5
June 2012.
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On May 21, 2012 - Active Biotech and Ipsen announced that recruitment
to the global, pivotal, randomized, double-blind, placebo-controlled
phase III study of tasquinimod in patients with metastatic
castrate-resistant prostate cancer (CRPC) had reached an inclusion of
600 patients, half of the planned accrual. This triggered a €10
million milestone payment from Ipsen to Active Biotech.
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On June 4, 2012 - Active Biotech and Ipsen presented overall survival
(OS) data from the tasquinimod Phase II study in chemotherapy-naïve
metastatic castrate resistant prostate cancer (CRPC) at the scientific
conference "2012 ASCO Annual Meeting" held in Chicago (USA).
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On June 29, 2012 - Ipsen announced that its partner Teijin received
manufacturing and marketing approval from the Japan's Ministry of
Health, Labour and Welfare (MHLW) for Somatuline® 60/90/120
mg for s.c. injection (lanreotide acetate). In Japan, Somatuline®
is indicated for the treatment of growth hormone and IGF-I
(somatomedin-C) hypersecretion and related symptoms in acromegaly and
pituitary gigantism (when response to surgical therapies is not
satisfactory or surgical therapies are difficult to perform).
Somatuline® will be available in a new enhanced
presentation with a pre-filled syringe that does not need
reconstitution and with a retractable needle that enhances safety for
caregivers.
-
On July 10, 2012 - Ipsen announced that its partner Inspiration
Biopharmaceuticals Inc. (Inspiration) was notified by the Food and
Drug Administration (FDA) that the two clinical trials evaluating the
safety and efficacy of IB1001 were placed on clinical hold. During the
course of routine laboratory evaluations conducted as part of the
ongoing phase III clinical trials, Inspiration observed, and reported
to the FDA, a trend towards a higher proportion of IB1001 treated
individuals developing a positive response to testing of antibodies to
Chinese Hamster Ovary (CHO) protein, the product's host cell protein
(HCP). A total of 86 people with hemophilia B have received IB1001 in
clinical studies and, to date, no adverse events (anaphylaxis or other
serious allergic type reaction and nephrotic syndrome) related to the
development of antibodies to CHO protein have been reported.
Furthermore, no relationship has been demonstrated between the
development of antibodies to CHO protein and the development of any
antibodies to factor IX. Inspiration continues to follow subjects
enrolled in clinical trials of IB1001 to collect safety-related
information and will share this information with regulators.
-
On July 11, 2012 - Ipsen announced its decision to retain the Dreux
(France)-based industrial facility within the scope of its activity.
Considering the perspectives of Ipsen's primary care activity
internationally and as a result the higher than-expected production
volumes at this site since the beginning of this year, the Group has
decided to keep its Dreux industrial site.
-
On August 21, 2012 - Ipsen announced the renegotiation of its 2010
strategic partnership agreement with Inspiration Biopharmaceuticals,
Inc. (Inspiration) for the development and commercialization of
Inspiration's recombinant product portfolio: OBI-1, a recombinant
porcine factor VIII (rpFVIII) being developed for the treatment of
patients with acquired hemophilia A and congenital hemophilia A with
inhibitors, and IB1001, a recombinant factor IX (rFIX) for the
treatment and prevention of bleeding in patients with hemophilia B.
The new agreement aims to establish an effective structure whereby
Ipsen gains commercial rights in key territories. Inspiration remains
responsible for the world-wide development of OBI-1 and IB1001. As
part of the renegotiation, Ipsen paid Inspiration $30.0 million
(approximately €24.0 million, based on current exchange rates)
upfront. Including this upfront payment, Ipsen is entitled to pay
Inspiration milestones for a total amount of up to $200m, of which
$27.5m are regulatory milestones and the remaining are commercial
milestones.
-
On September 10, 2012 - Ipsen announced that it has avoided an
interruption in US supply of Increlex® (IGF-1) for the
treatment of Severe Primary IGF-1 Deficiency due to delays in
manufacturing site approval. Increlex® is an important drug
used to treat patients with Severe Primary IGF-1 Deficiency (Primary
IGFD) and is considered to be a drug of medical necessity. As a
result, Ipsen has worked closely with the US Food and Drug
Administration to maintain product supply.
-
On October 1, 2012 - Active Biotech and Ipsen have presented a new set
of data on biomarkers from the previously concluded tasquinimod Phase
II study in chemotherapy-naïve metastatic castrate resistant prostate
cancer (CRPC) at the scientific congress ESMO (European Society for
Medical Oncology) held in Vienna from 28 September to 02 October 2012.
-
On October 3, 2012 - Ipsen and Active Biotech announced the initiation
of a new phase II proof of concept clinical trial, evaluating the
activity of tasquinimod in advanced metastatic castrate resistant
prostate cancer patients. The study aims at establishing the clinical
efficacy of tasquinimod used as maintenance therapy in patients with
metastatic castrate-resistant prostate cancer (mCRPC) who have not
progressed after a first line docetaxel based chemotherapy.
-
On October 3, 2012 - Ipsen announced that Inspiration
Biopharmaceuticals Inc. (Inspiration) had not raised third party
financing by the contractual deadline of 30 September 2012.
Consequently, Ipsen is no longer obligated to pay the additional $12.5
million in exchange for Inspiration equity. The parties continue to
explore various options.
-
On October 19, 2012 - Ipsen announced that it will shortly initiate a
new phase II, proof-of-concept clinical trial with tasquinimod in a
so-called umbrella study evaluating the compound in four different
tumour types. The study will evaluate the safety and efficacy of
tasquinimod in advanced or metastatic hepato-cellular, ovarian, renal
cell and gastric carcinomas in patients who have progressed after
standard anti-tumor therapies.
-
On October 31 2012 - Ipsen announced that Inspiration
Biopharmaceuticals Inc. (Inspiration) has commenced a voluntary
reorganization case pursuant to Chapter 11's provisions of the United
States Bankruptcy Code. Inspiration's Chapter 11 case was filed on
October 30, 2012 with the United States Bankruptcy Court in Boston,
Massachusetts. With this filing, Inspiration seeked to have the
Bankruptcy Court's approval on detailed bidding and auction procedures
for the sale of its assets to a third party purchaser. Inspiration's
assets are notably comprised of commercial rights to OBI-1, a
recombinant porcine factor VIII (rpFVIII) for the treatment of
hemophilia A with inhibitors and IB1001, a recombinant factor IX
(rFIX) for the treatment of hemophilia B. Through its $200 million of
convertible bonds, Ipsen is Inspiration's only senior secured
creditor. Ipsen has agreed to include its hemophilia assets in the
sale process under certain conditions. Ipsen's assets are comprised of
commercial rights to OBI-1 and IB1001 as well as its OBI-1 industrial
facility in Milford (Boston, MA).
-
On November 20 2012 - Ipsen and Inspiration Biopharmaceuticals Inc.
(Inspiration) announced that Inspiration has received Fast Track
designation from the US Food and Drug Administration (FDA) for OBI-1
in acquired hemophilia A. OBI-1, an intravenous recombinant porcine
factor VIII (FVIII), is being evaluated for the treatment of
individuals with acquired hemophilia A, who have developed inhibitory
antibodies (inhibitors) against their innate FVIII. Fast track is a
designation that the FDA reserves for a drug intended to treat a
serious disease and has a potential to fill an unmet medical need.
Fast track designation is designed to facilitate the development and
expedite the review of new drugs. Marketing applications for fast
track development programs are likely to be considered appropriate for
priority review, which implies an abbreviated review time of eight
months. Inspiration intends to submit a biologics license application
(BLA) to FDA in the first half of 2013.
-
On December 3, 2012 -Ipsen and Galderma, a leading global
pharmaceutical company focused on dermatology, announced that their
collaboration for the promotion and distribution of Dysport®,
Ipsen's botulinum toxin type A in aesthetic indications, has been
extended. Both companies renewed their collaboration in Brazil and
Argentina and extended their partnership to Australia where Galderma
has the exclusive promotion and distribution rights for Ipsen's Dysport®
in aesthetic indications. Both companies also entered into a
co-promotion agreement in South Korea where Galderma and Ipsen will
co-promote Dysport® and Restylane®.
-
On December 10, 2012 - Active Biotech and Ipsen announced that the
Phase III clinical trial for tasquinimod, a novel compound for the
treatment of prostate cancer, is successfully enrolled with over 1,200
randomized patients as planned in the clinical protocol. This
achievement triggers a €10 million milestone payment from Ipsen to
Active Biotech.
-
On December 18, 2012 - Oncodesign, a Drug Discovery company and
oncology pharmacology service provider, and the Laboratory for
Neurobiology and Gene Therapy (LNGT) at the Department of
Neurosciences at the KU Leuven, an expert academic group exploring the
roles of LRRK2 and a-synuclein in Parkinson's disease headed by
Professor Veerle Baekelandt, announced that they have entered into a
research collaboration. The collaboration builds on Oncodesign's LRRK2
program with advanced Nanocyclix® lead molecules that was
partnered with Ipsen in January 2012.
After 31 December 2012, major developments included:
-
On January 17, 2013 - Teijin Pharma Limited, the core company of the
Teijin Group's healthcare business, and Ipsen announced the launch of
Somatuline® 60/90/120 mg for subcutaneous injection in
Japan for the treatment of acromegaly and pituitary gigantism (when
response to surgical therapies is not satisfactory or surgical
therapies are difficult to perform). In Japan, Teijin Pharma holds the
rights to develop and market the drug.
-
On January 24, 2013 - Ipsen and Inspiration Biopharmaceuticals Inc.
(Inspiration) today announced they entered into an Asset Purchase
Agreement (APA) whereby Baxter International (Baxter) agrees to
acquire the worldwide rights to OBI-1, a recombinant porcine factor
VIII (rpFVIII) in development for congenital hemophilia A with
inhibitors and acquired hemophilia A, and Ipsen's industrial facility
in Milford (Boston, MA). The APA was filed on 23 January 2013, with
the US Federal Bankruptcy Court in Boston (MA). The sale is a result
of joint marketing and sale process pursued by Ipsen and Inspiration
shortly after Inspiration filed for protection under Chapter 11 of the
U.S. Bankruptcy Code on October 30, 2012. The APA is subject to
certain closing conditions, including Bankruptcy Court and regulatory
approvals. Ipsen has agreed to extend the DIP to Inspiration for a
period of 45 days i.e. for an additional amount of up to c. $5 million.
-
On 6 February 2013 - Ipsen and Inspiration Biopharmaceuticals Inc.
(Inspiration) announced they entered into an Asset Purchase Agreement
(APA) whereby Cangene Corporation (Cangene) agrees to acquire the
worldwide rights to IB1001, a recombinant factor IX (rFIX) for the
treatment of hemophilia B. Under the terms of the APA, Cangene has
agreed to pay $5.9 million upfront, up to $50 million in potential
additional commercial milestones as well net sales payments equivalent
to tiered double digit percentage of IB1001 annual net sales. The APA
is subject to certain closing conditions including Bankruptcy Court
approval.
-
On 7 February 2013 - Ipsen and Braintree Laboratories, Inc., a
US-based company specializing in the development, manufacturing and
marketing of specialty pharmaceuticals announced today that Eziclen®
/ Izinova® (BLI-800) successfully completed its European
decentralized registration procedure involving sixteen countries. The
product will be indicated in adults for bowel cleansing prior to any
procedure requiring a clean bowel (e.g. bowel visualization including
bowel endoscopy and radiology or surgical procedure).
-
On 20 February 2013 - Ipsen and Inspiration Biopharmaceuticals Inc.
(Inspiration) announced the closing of the sale of the proprietary
hemophilia B product, IB1001 (recombinant FIX), to Cangene Corporation
(Cangene). Ipsen and Inspiration jointly agreed to sell their
respective commercialization rights to IB1001 as part of the
transaction. Cangene acquired worldwide rights to IB1001, a
recombinant factor IX currently under regulatory review in the United
States and Europe.
Administrative measures
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 are affecting the Group
sales and profitability in 2012. In addition, certain measures
introduced in 2011 have continued to affect the Group's accounts
year-on-year.
Measures impacting 2012
In the Major Western European countries:
-
In France, the price of Forlax® was reduced by 3.5% on 1
October, 2011 and the prices of Nisis®/Nisisco®
by 15.0% on 14 November, 2011. On 1 January, 2012, the price of
Decapeptyl® was reduced by 3.0% for both 3-month and
6-month formulations while the price of Adrovance® was
reduced by 33.0%. On 1 March 2012, Tanakan® was delisted in
France.
An additional tax on promotional expenses of 0.6% has
also been introduced. Moreover, sales of Nisis®/Nisisco®
and Forlax® were negatively impacted by a step-up in
July in the regulation known as « tiers-payant », whereby the patient
now pays upfront for a branded drug (when genericized) at the pharmacy
and is reimbursed only later on;
-
In Spain, as of 1 November, 2011, tax on drug sales was raised from
7.5% (introduced in June 2010) to 15.0% for products that have been on
the market for more than 10 years and have no generic or biosimilar on
the Spanish market. In addition, Tanakan® was
dereimbursed on 1 September 2012.
In the Other European countries:
-
In Belgium, as from 1 April 2012, as soon as a generic or a hybrid is
launched on the market, drugs are regrouped per active ingredient
regardless of their galenic form and prices are cut by up to 31.0%;
-
In Poland, a new Reimbursement Law Reform was enforced on 1 January
2012, introducing a sales tax in case of budget excess and a tax on
manufacturers' income to fund clinical trials. Regulated margins have
been decreased as well. As a result, prices of Decapeptyl®
and Somatuline® were both reduced by 3.0% on 1 January 2012;
-
Greece voted new measures designed to decrease pharmaceutical
expenditure. Key measures include higher rebates to wholesalers and
retail pharmacies (9.0% instead of 4.0% - retroactive effect as of 1
January 2012), an obligation to prescribe drugs labelled International
Non-proprietary Name (INN) through an e-prescription system and
introduction of a payback contribution in case of Health public budget
overrun;
-
In 2011, Portugal introduced an electronic system encouraging
prescription of the cheapest product (including generics). New
countries have been included in the reference basket for the
International Pricing System such as Slovakia, Spain and France. New
measures for 2013 have already been published: 6.0% price cut on all
drugs and contribution of the pharmaceutical industry to the decrease
of healthcare spending through the set up by every Pharma company of a
provision fund equal to 2.0% of sales;
-
In Hungary, a 10.0% additional tax on sales, on top of the 20.0% tax
already in force, was introduced as of 1 August 2012 for all Somatuline®
formulations;
-
In Czech Republic, VAT on drugs was increased from 9.0% to 14.0% in
January 2012.
In the Rest of the World:
-
China is finalizing its international reference pricing system
including ten countries including the USA, France, Germany, South
Korea and Japan;
-
In January 2011, Algeria set reference pricing per therapeutic class,
hence a price alignment of Decapeptyl® on the cheapest GnRH
seems imminent;
-
In Korea, under the volume-control regulation in force since November
2011, the price of the 11.25 mg formulation of Diphereline®
has been cut by 4.5% on 1 September, 2012;
Furthermore, and in the context of financial and economic crisis,
governments of many countries in which the Group operates continue to
introduce new measures to reduce public health expenses, some of them
will affect the Group sales and profitability beyond 2012. Health
Technology Assessment (HTA) methods are more broadly used in market
access decisions in several part of the world, including some emerging
countries and Eastern European countries.
Measures which may have impacts beyond 2012
In the Major Western European countries:
-
The Spanish Health Minister confirmed a 14.0% reduction of healthcare
budget in 2012. The new Royal Decree published in April 2011 stated
that molecules that have been introduced in Europe for more than ten
years will be regrouped per active ingredient and prices will be
aligned on the cheapest daily dosage;
-
In France, the taxable basis for the promotion tax has been
significantly extended to the institutional communication and
congresses by a decree published in December 2012, with a retroactive
impact since the beginning of the year;
-
In Italy, the cap for hospital expenditure has been increased from
2.4% to 3.5%. In addition, Pharma Companies will have to pay 50.0% of
any extra expenditure beyond this cap level;
In the Other European countries:
-
In Greece, a new price bulletin has been published in November 2011
based on the average of the 3 lowest prices within the Eurozone (27
countries), as well as a reimbursement reference price based on lower
product price of ATC4 classification and a co-payment change. They
should be in force in early 2013;
-
In Belgium, IRPP was updated with new rules and a reference basket of
6 countries (France, Germany, the Netherlands, Austria, Ireland and
Finland); it should be implemented in April 2013;
-
Within the frame of the Healthcare Reform, Russian Health Authorities
are considering a possible change in the price-setting methodology for
drugs on the Essential Drug List (EDL). Future registered prices for
drugs on EDL should be set as the weighted average price of all drugs
with the same International Non-proprietary Name (INN);
In the Rest of the World:
-
In Colombia, a new International Reference pricing system was
implemented during the second semester 2012, as well as maximum
reimbursement prices on expensive drugs. Somatuline® could
face a price cut in the range of 40%-50%;
-
Twelve Latin American countries (Argentina, Bolivia, Brazil, Chile,
Colombia, Ecuador, Guyana, Paraguay, Peru, Surinam, Uruguay, and
Venezuela) agreed to create a regional drug-pricing database in order
to harmonize drug prices. Launch and impacts are unknown at this stage;
-
In South Korea, price-volume agreements negotiated in 2011 which have
led to a 7.0% price decrease of Decapetpyl® and Dysport®
will continue to negatively impact prices in 2013 with a further 7,5%
decrease.
Comparison of consolidated income statement for 2012 and 2011
|
|
(in million euros)
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011 Proforma (2)
|
|
|
|
% change
|
|
|
|
|
|
|
|
% of sales
|
|
|
|
|
|
|
|
% of sales
|
|
|
|
Sales
|
|
|
|
1,219.5
|
|
|
|
100.0%
|
|
|
|
1,159.8
|
|
|
|
100.0%
|
|
|
|
5.1%
|
Other revenues
|
|
|
|
57.9
|
|
|
|
4.7%
|
|
|
|
50.4
|
|
|
|
4.3%
|
|
|
|
14.9%
|
Revenues
|
|
|
|
1,277.4
|
|
|
|
104.7%
|
|
|
|
1,210.2
|
|
|
|
104.3%
|
|
|
|
5.6%
|
Cost of goods sold
|
|
|
|
(254.8)
|
|
|
|
-20.9%
|
|
|
|
(249.2)
|
|
|
|
-21.5%
|
|
|
|
2.2%
|
Research and development expenses
|
|
|
|
(248.6)
|
|
|
|
-20.4%
|
|
|
|
(234.6)
|
|
|
|
-20.2%
|
|
|
|
5.9%
|
Selling expenses
|
|
|
|
(473.5)
|
|
|
|
-38.8%
|
|
|
|
(424.4)
|
|
|
|
-36.6%
|
|
|
|
11.6%
|
General and administrative expenses
|
|
|
|
(99.1)
|
|
|
|
-8.1%
|
|
|
|
(99.7)
|
|
|
|
-8.6%
|
|
|
|
-0.6%
|
Other operating income
|
|
|
|
5.6
|
|
|
|
0.5%
|
|
|
|
17.5
|
|
|
|
1.5%
|
|
|
|
-68.0%
|
Other operating expenses
|
|
|
|
(25.8)
|
|
|
|
-2.1%
|
|
|
|
(17.6)
|
|
|
|
-1.5%
|
|
|
|
46.4%
|
Depreciation of intangible assets
|
|
|
|
(5.8)
|
|
|
|
-0.5%
|
|
|
|
(7.8)
|
|
|
|
-0.7%
|
|
|
|
-26.5%
|
Restructuring costs
|
|
|
|
(63.1)
|
|
|
|
-5.2%
|
|
|
|
(36.5)
|
|
|
|
-3.2%
|
|
|
|
72.8%
|
Impairment gain/(losses)
|
|
|
|
2.4
|
|
|
|
0.2%
|
|
|
|
(85.2)
|
|
|
|
-7.3%
|
|
|
|
-102.8%
|
Operating income
|
|
|
|
114.8
|
|
|
|
9.4%
|
|
|
|
72.6
|
|
|
|
6.3%
|
|
|
|
58.2%
|
Recurring Adjusted operating income (1)
|
|
|
|
196.0
|
|
|
|
16.1%
|
|
|
|
197.5
|
|
|
|
17.0%
|
|
|
|
-0.8%
|
- Investment income
|
|
|
|
1.0
|
|
|
|
0.1%
|
|
|
|
1.6
|
|
|
|
0.1%
|
|
|
|
-37.8%
|
- Costs of financing
|
|
|
|
(2.3)
|
|
|
|
-0.2%
|
|
|
|
(1.8)
|
|
|
|
-0.2%
|
|
|
|
31.9%
|
Net financing cost
|
|
|
|
(1.3)
|
|
|
|
-0.1%
|
|
|
|
(0.2)
|
|
|
|
-0.0%
|
|
|
|
-
|
Other financial income and expense
|
|
|
|
6.8
|
|
|
|
0.6%
|
|
|
|
(0.5)
|
|
|
|
-0.0%
|
|
|
|
-
|
Income taxes
|
|
|
|
(24.4)
|
|
|
|
-2.0%
|
|
|
|
1.9
|
|
|
|
0.2%
|
|
|
|
-
|
Share of profit/loss from associated companies
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
Net profit/loss from continuing operations
|
|
|
|
95.8
|
|
|
|
7.9%
|
|
|
|
73.8
|
|
|
|
6.4%
|
|
|
|
29.9%
|
Net profit/loss from discontinued operations
|
|
|
|
(124.8)
|
|
|
|
-10.2%
|
|
|
|
(72.9)
|
|
|
|
-6.3%
|
|
|
|
71.3%
|
Consolidated net profit
|
|
|
|
(29.0)
|
|
|
|
-2.4%
|
|
|
|
0.9
|
|
|
|
0.1%
|
|
|
|
-
|
- Attributable to shareholders of Ipsen S.A.
|
|
|
|
(29.5)
|
|
|
|
|
|
|
|
0.4
|
|
|
|
|
|
|
|
|
- Minority interests
|
|
|
|
0.5
|
|
|
|
|
|
|
|
0.5
|
|
|
|
|
|
|
|
|
(1) See appendix 4
|
(2) In compliance with provisions on
"discontinued activities", 2011 figures have been restated to
provide comparative information between 2011 and 2012
(see appendix 5)
|
|
Consolidated Group sales reached € 1,219.5 million as of 31 December
2012, up 5.1% year-on-year or up 3.3% excluding foreign exchange impact1.
Other revenues amounted to € 57.9 million in 2012, up 14.9% compared to
€ 50.4 million in 2011.
Other revenues breakdown is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in million euros)
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011 Proforma (2)
|
|
|
|
Change
|
|
|
|
|
|
|
|
|
|
In value
|
|
|
|
in %
|
Breakdown by type of revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- Royalties received
|
|
|
|
11.9
|
|
|
|
9.1
|
|
|
|
2.8
|
|
|
|
30.9%
|
- Milestone payments - licensing agreements (1)
|
|
|
|
25.1
|
|
|
|
23.5
|
|
|
|
1.6
|
|
|
|
6.7%
|
- Other (co-promotion revenues, re-billings)
|
|
|
|
20.9
|
|
|
|
17.8
|
|
|
|
3.1
|
|
|
|
17.6%
|
Total
|
|
|
|
57.9
|
|
|
|
50.4
|
|
|
|
7.5
|
|
|
|
14.9%
|
(1) Milestone payments relating to licensing
agreements primarily represent recognition of payments received
over the life of partnership agreements
|
(2) In compliance with provisions on
"discontinued activities", 2011 figures have been restated to
provide comparative information between 2011 and 2012
(see appendix 5)
|
|
-
Royalties received amounted to €11.9 million in 2012, up €2.8
million year-on-year, driven by the increase in royalties paid by the
Group's partners.
-
Milestone payments relating to licensing agreements amounted to
€25.1 million, mainly generated by the partnerships with Medicis,
Menarini and Galderma.
-
Other revenues amounted to €20.9 million in 2012 compared with
€17.8 million a year earlier, driven by the revenues relating to the
Group's co-promotion and co-marketing agreements in France as well as
promotion of Hexvix® in some countries.
1 Variations excluding foreign exchange impacts are computed
by restating the 2011 figures with the 2012 average exchange rates
In 2012, cost of goods sold amounted to €254.8 million, representing
20.9% of sales, compared with €249.2 million, or 21.5% of sales, for the
same period in 2011.
The cost of goods sold, positively impacted by the favourable mix
related to the growth in specialty care sales and the Group's
productivity efforts, was partially offset by custom duties in high
growth countries.
-
Research and development expenses
At 31 December 2012, research and development expenses represented
€248.6 million or 20.4% of sales, compared with 20.2% the previous year.
The table below provides a comparison of research and development
expenses during the full years 2012 and 2011, according to the new
segmentation of research and development expenses as defined by the new
strategy announced on 9 June 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in million euros)
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011 Proforma(4)
|
|
|
|
Change
|
|
|
|
|
|
|
|
|
|
In value
|
|
|
|
in %
|
Breakdown by expenses type
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- Drug-related research and development(1)
|
|
|
|
(199.4)
|
|
|
|
(192.0)
|
|
|
|
(7.3)
|
|
|
|
3.8%
|
- Industrial and pharmaceutical development(2)
|
|
|
|
(40.8)
|
|
|
|
(35.5)
|
|
|
|
(5.3)
|
|
|
|
14.9%
|
- Strategic development(3)
|
|
|
|
(8.4)
|
|
|
|
(7.1)
|
|
|
|
(1.3)
|
|
|
|
18.6%
|
Total
|
|
|
|
(248.6)
|
|
|
|
(234.6)
|
|
|
|
(13.9)
|
|
|
|
5.9%
|
(1) Drug-related research & development is aimed at identifying
new agents, determining their biological characteristics and
developing small-scale manufacturing processes. The expenses
relating to patents are also included in this type of expense
|
(2) Industrial development includes chemical, biotechnical and
development-process research costs to industrialize small-scale production
of agents developed by the research laboratories. Pharmaceutical
development is the process through which active agents become
drugs approved by regulatory authorities and is also used to
improve existing drugs and to search new therapeutic indications
for them. Pharmaceutical development is associated to industrial
development after bringing together both activities in the
framework of the new strategy announced on 9 June 2011, in order
to build a Department « Chemistry, Manufacturing, Controls
& Engineering »
|
(3) Strategic development includes costs incurred for research
into new product licenses and establishing partnership agreements
|
|
In compliance with provisions on "discontinued activities", 2011 figures
have been restated to provide comparative information between 2011 and
2012 (see appendix 5)
-
Research and development drug-related costs increased by 3.8%
compared to the prior year. The main research and development projects
conducted in 2012 focused on Dysport®, Somatuline®
and tasquinimod. This increase was partially offset by a favourable
comparison basis: costs related to the phase II clinical study of
Irosustat (BN-83495) were no longer recorded in 2012 as the program
was discontinued on 6 June 2011.
-
Industrial and pharmaceutical development expenses increased by
14.9% year-on-year in 2012, mainly resulting from investments in the
Group's toxins and peptides technology platforms.
-
Selling, general and administrative expenses
Selling, general and administrative expenses amounted to €572.6 million
in 2012, representing 46.9% of sales, up 9.3% versus 2011.
|
|
|
|
|
|
|
|
|
|
|
|
|
(in million euros)
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011 Proforma(1)
|
|
|
|
Change
|
|
|
|
|
|
|
|
|
|
In value
|
|
|
|
in %
|
Breakdown by expense type
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties paid
|
|
|
|
(51.7)
|
|
|
|
(46.6)
|
|
|
|
(5.1)
|
|
|
|
11.0%
|
Other sales and marketing expenses
|
|
|
|
(421.7)
|
|
|
|
(377.8)
|
|
|
|
(43.9)
|
|
|
|
11.6%
|
Selling expenses
|
|
|
|
(473.5)
|
|
|
|
(424.4)
|
|
|
|
(49.1)
|
|
|
|
11.6%
|
General and administrative expenses
|
|
|
|
(99.1)
|
|
|
|
(99.7)
|
|
|
|
0.6
|
|
|
|
-0.6%
|
Total
|
|
|
|
(572.6)
|
|
|
|
(524.1)
|
|
|
|
(48.5)
|
|
|
|
9.3%
|
The table below provides a comparison of selling, general and
administrative expenses in 2012 and 2011:
(1) In compliance with provisions on "discontinued activities", 2011
figures have been restated to provide comparative information between
2011 and 2012 (see appendix 5)
-
Selling expenses amounted to €473.5 million in 2012, or 38.8%
of sales, compared to €424.4 million, or 36.6% of sales, in 2011.
-
Royalties paid to third parties on sales of products marketed by the
Group amounted to €51.7 million in 2012, up 11.0% year-on-year. This
increase was driven by improved in-market sales of in-licensed
products ;
-
Other selling expenses amounted to €421.7 million, or 34.6% of sales,
up 11.6% compared to €377.8 million, or 32.6% of sales, in 2011. In
line with the strategy announced on 9 June 2011, the Group continued
to increase commercial investments in specialty care while selectively
allocating business resources to high growth areas mainly China,
Russia and Brazil. Furthermore selling expenses related to primary
care in France increased proportionally to declining sales. Synergies
from the new organization of French primary care commercial operations
are expected to materialize in 2014.
-
General and administrative expenses slightly decreased by 0.6%
in 2012.
-
Other operating income and expenses
Other operating income amounted to €5.6 million in 2012, compared with
€17.5 million the previous year, mainly composed of revenues from the
sublease of Ipsen's headquarters building. In 2011, the other operating
income was composed of a non-recurring income of €17.2 million following
the enforceable court judgment relating to the trade dispute between the
Group and Mylan.
Other operating expenses amounted to €25.8 million, compared with €17.6
million for the same period in 2011. The other operating expenses were
mainly composed of non-recurring costs resulting from the search for
potential acquirers for the Dreux industrial site, for potential
partners for the primary care activity in France, the settlement of a
trade dispute with a partner and an administrative procedure involving
the Group.
-
Amortisation of intangible assets (excluding software)
In 2012, amortization charges of intangible assets reached €5.8 million,
compared to €7.8 million the previous year. This decrease is mainly due
to the change in the amortization plan of IGF-1 following the impairment
loss recorded on 31 December 2011 and to the amortization completion of
Exforge® (end of co-promotion contract in France with
Novartis effective since 30 April 2012). This decrease was partially
offset by the initiation of Hexvix® amortization.
At 31 December 2012, the Group recorded non-recurring restructuring
costs of €63.1 million, mainly related to the implementation of the new
organization of French primary care commercial operations and to the
transfer to the East coast of the Group's North American commercial
subsidiary that occurred between June 2011 and June 2012.
At 31 December 2012, the Group recorded a non-recurring revenue of
€2.4million. Following the announcement to retain the Dreux-based
industrial facility within its scope of activity, the Group reassessed
the value of this asset and recorded an impairment write-back of €12.5
million in its consolidated financial statements as of 30 June 2012. The
Group recorded a €10.1 million impairment charge on the brand of Nisis®/Nisisco®,
following a step-up in July 2012 in France in the regulation known as «
Tiers-Payant », whereby the patient now pays upfront for a branded drug
and is later reimbursed. This has generated an unprecedented and sudden
increase in generic penetration in France.
Based on above items, the operating income reported in 2012 amounted to
€114.8 million or 9.4% of sales, up 58.2% compared to 2011, where it
represented 6.3% of Group's sales.
The Group's recurring adjusted2 operating
income in 2012 amounted to €196 million or 16.1% of consolidated
sales, down 0.8% year-on-year.
-
Operating segments: Operating income by geographical regions
Internal reporting provided to the Executive Committee corresponds to
the Group's managerial organisation based on the geographical regions
within which the Group operates. Accordingly, operating segments as
defined by IFRS8, equal to long-term groupings of countries.
The operating segments existing as of 31 December 2012 are as follows:
-
"Main Western European countries", which combines France, Italy,
Spain, United Kingdom and Germany;
-
"Other European countries", which combines Other in Western European
countries and Eastern European countries;
-
"North America", which includes essentially the United States;
-
"Rest of the world", which includes the countries not included in the
three preceding segments.
The table below provides an analysis of sales, revenues and operating
income by operating segment for the 2012 and 2011 periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011 Proforma*
|
|
|
|
Change
|
(in thousand euros)
|
|
|
|
|
|
|
|
% of sales
|
|
|
|
|
|
|
|
% of sales
|
|
|
|
|
|
|
|
%
|
Major Western European countries (1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales of goods
|
|
|
|
518.5
|
|
|
|
100.0%
|
|
|
|
542.0
|
|
|
|
100.0%
|
|
|
|
(23.5)
|
|
|
|
-4.3%
|
Revenue
|
|
|
|
549.9
|
|
|
|
106.0%
|
|
|
|
567.5
|
|
|
|
104.7%
|
|
|
|
(17.6)
|
|
|
|
-3.1%
|
Operating income
|
|
|
|
138.3
|
|
|
|
26.7%
|
|
|
|
155.9
|
|
|
|
28.8%
|
|
|
|
(17.6)
|
|
|
|
-11.3%
|
Other European countries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales of goods
|
|
|
|
306.0
|
|
|
|
100.0%
|
|
|
|
279.6
|
|
|
|
100.0%
|
|
|
|
26.5
|
|
|
|
9.5%
|
Revenue
|
|
|
|
312.2
|
|
|
|
102.0%
|
|
|
|
284.8
|
|
|
|
101.8%
|
|
|
|
27.4
|
|
|
|
9.6%
|
Operating income
|
|
|
|
135.7
|
|
|
|
44.4%
|
|
|
|
118.4
|
|
|
|
42.3%
|
|
|
|
17.4
|
|
|
|
14.7%
|
North America
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales of goods
|
|
|
|
72.8
|
|
|
|
100.0%
|
|
|
|
65.7
|
|
|
|
100.0%
|
|
|
|
7.1
|
|
|
|
10.8%
|
Revenue
|
|
|
|
90.5
|
|
|
|
124.4%
|
|
|
|
82.8
|
|
|
|
126.0%
|
|
|
|
7.7
|
|
|
|
9.3%
|
Operating income
|
|
|
|
(10.5)
|
|
|
|
-14.5%
|
|
|
|
(35.7)
|
|
|
|
-54.4%
|
|
|
|
25.2
|
|
|
|
-70.6%
|
Rest of the World
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales of goods
|
|
|
|
322.2
|
|
|
|
100.0%
|
|
|
|
272.5
|
|
|
|
100.0%
|
|
|
|
49.7
|
|
|
|
18.2%
|
Revenue
|
|
|
|
323.5
|
|
|
|
100.4%
|
|
|
|
273.2
|
|
|
|
100.3%
|
|
|
|
50.3
|
|
|
|
18.4%
|
Operating income
|
|
|
|
123.2
|
|
|
|
38.2%
|
|
|
|
106.4
|
|
|
|
39.1%
|
|
|
|
16.7
|
|
|
|
15.7%
|
Total Allocated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales of goods
|
|
|
|
1 219.5
|
|
|
|
100.0%
|
|
|
|
1 159.8
|
|
|
|
100.0%
|
|
|
|
59.7
|
|
|
|
5.1%
|
Revenue
|
|
|
|
1 276.1
|
|
|
|
104.6%
|
|
|
|
1 208.3
|
|
|
|
104.2%
|
|
|
|
67.8
|
|
|
|
5.6%
|
Operating income
|
|
|
|
386.7
|
|
|
|
31.7%
|
|
|
|
345.0
|
|
|
|
29.7%
|
|
|
|
41.7
|
|
|
|
12.1%
|
Total non-allocated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
1.3
|
|
|
|
-
|
|
|
|
1.9
|
|
|
|
-
|
|
|
|
(0.6)
|
|
|
|
-30.6%
|
Operating income
|
|
|
|
(271.9)
|
|
|
|
-
|
|
|
|
(272.4)
|
|
|
|
-
|
|
|
|
0.5
|
|
|
|
-0.2%
|
Total Group
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales of goods
|
|
|
|
1 219.5
|
|
|
|
100.0%
|
|
|
|
1 159.8
|
|
|
|
100.0%
|
|
|
|
59.7
|
|
|
|
5.1%
|
Revenue
|
|
|
|
1 277.4
|
|
|
|
104.7%
|
|
|
|
1 210.2
|
|
|
|
104.3%
|
|
|
|
67.2
|
|
|
|
5.6%
|
Operating income
|
|
|
|
114.8
|
|
|
|
9.4%
|
|
|
|
72.6
|
|
|
|
6.3%
|
|
|
|
42.2
|
|
|
|
58.2%
|
* In compliance with provisions on "discontinued activities",
2011 figures have been restated to provide comparative information
between 2011 and 2012 (see appendix 5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales generated in the Major Western European countries amounted
to €518.5 million in 2012, down 4.9% year-on-year excluding foreign
exchange impacts3. Dynamic volume sales growth of specialty
care products were more than offset by the consequences of a tougher
competitive environment in the French primary care landscape and
administrative measures in Spain. As a result, sales in the Major
Western European countries represented 42.5% of total Group sales at the
end of 2012, compared to 46.7% a year earlier. The Group recorded a
€10.1 million impairment charge on the brand of Nisis®/Nisisco®,
following a step-up in July 2012 in France in the regulation known as «
Tiers-Payant », which has generated an unprecedented and sudden increase
in generic penetration. The Group also recorded non-recurring
restructuring cost related to the implementation of the new organization
of French primary care commercial operations. Operating income in 2012
amounted to €138.3 million, down 11.3% year-on-year, representing 26.7%
of sales, compared to 28.8% for the same period in 2011. Excluding
non-recurring impacts, operating income in 2012 reached €204.1 million,
compared to €223.9 million in 2011.
Sales generated in the Other European countries reached €306.0
million in 2012, up 8.5% year-on-year excluding foreign exchange impacts4.
Sales were mainly driven by Russia with the good performance of
specialty care products and Tanakan®. Over the period,
Poland, the Netherlands, Ukraine and Belgium also contributed to the
volume growth. In 2012, sales in this region represented 25.1% of total
consolidated Group sales, compared to 24.1% a year earlier. Operating
income in 2012 amounted to €135.7 million compared to €118.4 million in
2011, representing 44.4% of sales for 2012, compared with 42.3% over the
same period in 2011.
In 2012, sales generated in North America amounted to €72.8
million, up 2.3% excluding foreign exchange impacts1.
Restated to exclude Apokyn® sales, North American sales were
up 11.5% year-on-year, driven by strong supply of Dysport®
for aesthetic use to Medicis, by the continuous penetration of Somatuline®
in acromegaly and by the growth of Dysport® in the treatment
of cervical dystonia. Sales in North America represented 6.0% of total
consolidated Group sales, compared to 5.7% a year earlier. Operating
income in 2012 amounted to (€10.5) million, up €25.2 million compared to
2011. This increase is mainly due to non-recurring costs booked in 2011,
of which €10.9 million related to the transfer to the East coast of the
Group's North American commercial subsidiary and €24.4 million
impairment charge on IGF-1.
In 2012, in the Rest of the World, where the Group markets
most of its products through distributors or commercial agents, sales
reached €322.2 million, up 14.1% excluding foreign exchange impacts1,
driven by a strong volume growth in China, Colombia, Vietnam, Australia,
Brazil and Mexico. In 2012, sales in the Rest of the World continued to
increase, representing 26.4% of total consolidated Group sales, compared
to 23.5% a year earlier. Operating income in 2012 amounted to €123.2
million, or 38.2% of sales, up 15.7% compared to €106.4 million, or
39.1% of sales, in 2011.
Non allocated operating income amounted to (€271.9) million in
2012 versus (€272.4) million in 2011. It mainly included the Group's
central research and developments costs for (€203.9) million in 2012 and
(€194.2) million in 2011 and, to a lesser extent, unallocated general
and administrative expenses.
1 See appendix 4 1 Variations excluding
foreign exchange impacts are computed by restating the 2011 figures with
the 2012 average exchange rates
-
Costs of net financial debt and other financial income and expenses
In 2012, the Group's financial result amounted to (€5.5) million
compared with (€0.7) million the prior year
-
The cost of net financial debt amounted to €1.3 million in
2012, compared to €0.2 million in 2011, mainly including the
non-utilisation fees on the new credit line subscribed on 31 January
2012, partially offset by cash investment income.
-
The other financial income and expenses amounted to €6.8
million in 2012 versus €(0.5) million in 2011. As of 31 December 2011,
the Group had recorded a €36.4 million loss, mainly comprising a €42.0
million non-recurring impairment loss on the four convertible bonds
issued by Inspiration and subscribed by the Group, partially offset by
a €6.1 million positive foreign exchange impact mainly related to the
revaluation of these four convertible bonds. In the 2011 proforma
accounts, those impacts are recorded in the discontinued operations
line following Ipsen announcement on 30 October 2012 to sell all its
hemophilia-related assets and to exit this therapeutic area. Restated
to exclude the above elements, the year-on- year increase mainly
resulted from positive foreign exchange rates, a profit derived from
the sale of its Spirogen shares, and a non-recurring profit derived
from additional payments received upon the divestment by the Group in
2010 of its shares in PregLem Holding SA.
-
Income taxes
On 31 December 2012, the effective tax rate (ETR) was 20.3% of profit
before tax from continuing activities, compared to an ETR of (2.6)% on
31 December 2011.
The items reducing the Group's effective tax rate were applied to an
increased profit before tax. As a consequence, the research tax credit,
while stable in volume between 2011 and 2012, had a diluted positive
impact, down 13 points. Also, the effect of reduced corporate tax rates
in comparison with standard French corporate tax rate was diluted by 8
points between 2011 and 2012.
Excluding non-recurring operating, financing and tax items, the
effective tax rate amounted to 23.2% in 2012 compared to 19.3% in 2011.
1 Variations excluding foreign exchange impacts are computed
by restating the 2011 figures with the 2012 average exchange rates
-
Share of profit / loss from associated companies
At 31 December 2011 and 2012, share of profit / loss from associated
companies was nil. The Group's 22.0% stake in Inspiration's net loss was
recorded in the discontinued operations line as mentioned below.
-
Net profit from continuing operations
As a result of the items above, the profit from continuing operations in
2012 amounted to €95.8 million, up 29.9% compared to €73.8 million in
2011. It represented 7.9% Group's sales in 2012 and 6.4% in 2011.
Recurring adjusted5 profit from continuing
operations amounted to €145.5 million in 2012, compared to €154.4
million in 2011, down 5.8% year-on-year.
-
Profit from discontinued operations
Profit from discontinued operations amounted to (€124.8 million) as of
31 December 2012, versus (€72.9) millions at the end of 2011. It
comprised the activities related to Inspiration. On 30 October 2012,
Ipsen and Inspiration decided to sell all their hemophilia-related
assets and Ipsen announced its exit from this therapeutic area.
Reminder of the evolution of Inspiration's
situation
On 10 July 2012, Ipsen's partner in hemophilia, Inspiration, was
notified by the Food and Drug Administration (FDA) that both clinical
trials evaluating the safety and efficacy of IB1001, an investigational
intravenous recombinant factor IX (rFIX) therapy for the treatment and
prevention of bleeding episodes in people with hemophilia B, were placed
on clinical hold.
In this context, on 21 August 2012, Ipsen announced the renegotiation of
its 2010 strategic partnership agreement with Inspiration for the
development and commercialization of IB1001 and OBI-1, a recombinant
porcine factor VIII (rpFVIII) being developed for the treatment of
patients with acquired hemophilia A and congenital hemophilia A with
inhibitors. The new agreement aimed to establish a structure whereby
Ipsen gained commercial rights in its key territories while Inspiration
remained responsible for the world-wide development of OBI-1 and IB1001.
As part of the renegotiation, Ipsen paid Inspiration $30.0 million
upfront and, in certain countries6, has:
-
recovered OBI-1 commercial rights
-
gained IB1001 commercial rights
Ipsen had agreed to pay Inspiration an additional financing if
Inspiration raised third party financing by the end of the third quarter
2012.
As Inspiration did not manage to raise external financing and was cash
constrained, it commenced, on 30 October 2012, a voluntary
reorganization case pursuant to Chapter 11's provisions of the United
States Bankruptcy Code with the objective of leading a joint marketing
and sales process. Inspiration's assets include commercial rights on
OBI-1 and IB1001 on several countries. With this filing, Inspiration
sought to have the Bankruptcy Court's approval on detailed bidding and
auction procedures for the sale of its assets to a third party
purchaser. Inspiration's assets are notably comprised of commercial
rights to OBI-1 and IB1001 in certain countries7.
Ipsen agreed to include its hemophilia assets in the sale process.
Ipsen's assets are comprised of commercial rights to OBI-1 and IB1001 as
well as its OBI-1 industrial facility in Milford (Boston, MA).
Inspiration and Ipsen jointly mandated an investment bank for the
transaction.
Under the Chapter 11 procedure, Ipsen agreed to provide Inspiration with
so-called: "Debtor-in-Possession financing" (DIP) for an amount of up to
$18.3 million assuming certain conditions were met. The DIP financing
allows a company with debt to undertake, under acceptance by its
creditors, some restructuring actions according to a plan which has been
defined and approved by the Court. It was anticipated that the DIP
financing was sufficient to enable Inspiration and Ipsen to successfully
sell their assets.
As Ipsen announced it put all its hemophilia-related assets up for sale,
it officially showed its intention to exit the specialized therapeutic
area of hemophilia. As a consequence, in compliance with IFRS5, the
Group classified all its hemophilia-related income and expense in «
Profit from discontinued operations ». Furthermore, in compliance with
IFRS5 « Non-current Assets Held for Sale and Discontinued Operations »,
all assets and liabilities related to hemophilia (excluding DIP
financing) have been classified as of 31 December 2012 in « non-current
asset as held for sale» in the Group's consolidated financial statements.
Hemophilia was one of the four focus and investment therapeutic areas
for Ipsen. Furthermore, flows from this activity are clearly identified
and the business is included in an exclusive and organized sales plan.
In this regard, this activity meets the "discontinued operations"
requirements; hence the associated result for the period is recorded on
a separate line on the consolidated Income statement. This line is
composed of the loss from "discontinued operations" and the loss after
tax resulting from valuation at fair value less the estimated costs
necessary to make the sale.
On 24 January 2013, Ipsen and Inspiration announced that they entered
into an Asset Purchase Agreement (APA) for the sale of OBI-1 to Baxter
International. Under the terms of the APA, Baxter has agreed to pay $50
million upfront, and potential additional development and commercial
milestones.
This APA is subject to Fair Trade Commission (FTC) approval.
On 6 February 2013, Ipsen and Inspiration announced they entered into an
Asset Purchase Agreement (APA) whereby Cangene Corporation (Cangene)
agrees to acquire the worldwide rights to IB1001. Under the terms of the
APA, Cangene has agreed to pay $5.9 million upfront and potential
additional commercial milestones.
The Group reassessed the value of its hemophilia assets, now recorded in
«non-current asset held for sale», and valued at the lower of carrying
amount and fair value less the estimated costs necessary to make the
sale. The milestones payments being contingent on regulatory approvals
and products sales, the Group estimated that they were not certain
income and, hence, did not include them in the fair value calculation of
hemophilia assets held for sale as of 31 December 2012.
On the basis of available information at closing date, the share of
upfront payment to be received by Ipsen should mainly cover the total
amount of DIP financing provided to Inspiration. As a consequence, the
Group, as of 31 December 2012, impaired all hemophilia related assets
and liabilities, classified as « non-current asset as held for sale » on
the balance sheet.
Hence, profit from discontinued operations mainly comprised
non-recurring provisions of €100m after tax on tangible, intangible and
financial assets, receivables related to the OBI-1 development costs for
the second and third quarters of 2012, the rebilling of the costs
associated with the implementation of the European platform, partially
offset by acceleration of recognition of deferred revenues related to
hemophilia. It also comprised the share of loss in Inspiration's result
for the period before it was classified as "discontinued operations".
1 See appendix 4 2 Europe (EU, Switzerland,
Monaco, Norway, Lichtenstein, Georgia, Bosnia, Albania and all EU
candidates excluding Turkey), Russia and CIS (Community of Independent
States), part of Asia Pacific (main countries are Australia, New
Zealand, China, Singapore, South Korea and Vietnam) and certain
countries in North Africa (Morocco, Algeria, Tunisia, Libya) 1
Mainly the Americas and Japan
As a result of the items above, consolidated net profit in 2012 was a
loss of €29 (attributable to shareholders of Ipsen S.A.:
(€29.5) million) compared with a profit of €0.9 million (attributable to
shareholders of Ipsen S.A.: €0.4 million) in 2011.
The Recurring adjusted consolidated net profit8
amounted to €145.5 million at 31 December 2012, down 5.8% compared with
€154.4 million in 2011.
The Group's earnings per share at 31 December 2012 amounted to €(0.35),
compared with €0.01 a year earlier.
The recurring adjusted1 diluted earnings per
share attributable to the Group at 31 December 2012 amounted to
€1.74, down by 5.9% year-on-year.
-
Milestone payments received in cash but not yet recognised in the
Group income statement
At 31 December 2012, the total of milestone payments received in cash by
the Group and not yet recognised as other revenues on the income
statement amounted to €152.4 million, compared with €199.0 million the
previous year.
The Group recorded no new deferred revenue for its partnerships. All
deferred income related to Inspiration (€28.0 million) was written back
in 2012 following Inspiration decision to seek protection under Chapter
11 of the United States Bankruptcy Code on 30 October 2012.
These deferred revenues will be recognised in the Group's future income
statements as follows:
|
|
|
|
|
|
|
|
|
(in million euros)
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011**
|
|
|
|
|
|
|
Total*
|
|
|
|
152.4
|
|
|
|
199.0
|
Deferred revenues will be recognised over time as follows:
|
|
|
|
|
|
|
|
|
In the year n+1
|
|
|
|
|
|
|
|
22.4
|
|
|
|
26.0
|
In the years n+2 and beyond
|
|
|
|
|
|
|
|
130.0
|
|
|
|
173.0
|
* Amounts converted at average exchange rate at 31 December
2012 and 31 December 2011 respectively
|
** In compliance with provisions on "discontinued activities",
2011 figures have been restated to provide comparative information between
2011 and 2012 (see appendix 5)
|
|
1 See appendix 4
CASH FLOW AND CAPITAL
The consolidated cash flow statement shows that the Group's operating
activities in December 2012 generated a net cash flow of €165.0 million,
slightly down compared with €168.8 million generated over the same
period in 2011.
Analysis of the cash flow statement
|
|
|
|
|
|
|
|
|
|
(in million euros)
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011 Proforma*
|
- Cash generated from operating activities before changes in
working capital requirements
|
|
|
|
175.3
|
|
|
|
189.5
|
- (Increases) / Decreases in working capital requirements for
operations
|
|
|
|
(10.3)
|
|
|
|
(20.7)
|
-
Net cash flow from operating activities
|
|
|
|
165.0
|
|
|
|
168.8
|
- Net investments in tangible and intangible assets
|
|
|
|
(76.5)
|
|
|
|
(95.2)
|
- Impact of changes in consolidation scope
|
|
|
|
(0.2)
|
|
|
|
-
|
- Other cash flow from investments
|
|
|
|
11.9
|
|
|
|
(2.6)
|
-
Net cash flow from investing activities
|
|
|
|
(64.8)
|
|
|
|
(95.7)
|
|
|
|
|
|
|
|
|
|
-
Net cash flow from financing activities
|
|
|
|
(73.2)
|
|
|
|
(65.2)
|
-
Net cash flow from discontinued operations**
|
|
|
|
(56.2)
|
|
|
|
(40.2)
|
CHANGES IN CASH AND CASH EQUIVALENTS
|
|
|
|
(29.2)
|
|
|
|
(32.9)
|
Opening cash and cash equivalents
|
|
|
|
144.8
|
|
|
|
177.9
|
Forex impact
|
|
|
|
(2.3)
|
|
|
|
(0.2)
|
Closing cash and cash equivalents
|
|
|
|
113.3
|
|
|
|
144.8
|
* In compliance with provisions on "discontinued
activities", 2011 figures have been restated to provide
comparative information between 2011 and 2012 (see
appendix 5)
|
** see " Net cash flow from discontinued operations"
|
|
-
Net cash flow from operating activities
Cash flow from operating activities in 2012 amounted to €175.3 million,
down compared with €189.5 million generated in 2011.
Working capital requirements for operating activities increased by
€10.3 million in 2012, against an increase of €20.7 million in 2011.
This change in 2012 was related to the following:
-
Inventories increased by €7.1 million in 2012 as a result of
reconstitution of stocks in high growth territories such as Russia and
Brazil.
-
Accounts receivables decreased by €10.1 million in 2012, compared with
an increase of €16.7 million in 2011, mainly due to decrease of public
receivables in Southern Europe, mainly Italy, Spain and Portugal.
-
Trade payables increased by €15.0 million in 2012, compared with an
increase of €9.4 million in 2011.
-
The change in other assets and liabilities comprised a use of fund of
€10.9 million in 2012, against a use of fund of €13.1 million in 2011.
In 2012, the Group recorded no deferred revenues from partnerships,
against €10.6 million in 2011. The Group recorded €24.5 million of
deferred revenues from partnerships on its income statement, against
of €25.8 million in 2011.
-
The change in net tax liability in 2012 represented a use of funds of
€17.4 million related to the payment of an excess amount of tax to
authorities with an expected reimbursement in 2013.
-
Net cash flow from investing activities
In 2012, the net cash flow from investing activities represented a net
use of funds of €64.8 million, compared to a net use of €95.7 million in
2011. It included:
-
Investments in tangible and intangible assets net of disposals,
amounting to €76.5 million, compared with €95.2 million the previous
year. This cash flow mainly included:
-
Acquisition of property, plant and equipment totalling €49.0 million,
compared with €44.3 million in 2011. These investments mainly
comprised items required for the maintenance of the Group's industrial
facilities and in capacity investments in the Wrexham and Signes
factories;
-
Investments in intangible assets for €27.7 million, compared with
€58.0 million in 2011, mainly related to the partnership with Active
Biotech for the rights of tasquinimod (€20 million) and Photocure pour
Hexvix® (€1.5 million);
-
A net cash flow of €13.9 million composed of the disposal of shares,
mainly from additional payments received upon the divestment by the
Group in 2010 of its shares in PregLem Holding SA;
-
A use of funds of €7.5 million related to investing activities, mainly
related to a €6.1 million payment of plan asset;
-
A decrease of €5.3 million in working capital requirements related to
investment activity, mainly related to a liability recorded in 2012
and payable to Active Biotech following the announcement of the
completion of the recruitment of the clinical trial of phase III with
tasquinimod;
-
Net cash flow from financing activities
In 2012, the net cash flow used in financing activities amounted to
€66.0 million, compared with a net use of €65.2 million over the same
period in 2011. In 2012, the Group paid €67.5 million in dividends to
its shareholders, up 1.5% compared with €66.5 million paid a year
earlier.
Under the Chapter 11 procedure, the Group provided Inspiration with
"Debtor-in-possession" (DIP) financing amounting to €7.5 million as of
31 December 2012. The purpose of this financing is to enable the sale of
Inspiration and Ipsen assets.
-
Net cash flow from discontinued operations
As of 31 December 2012, the net cash flow from discontinued activities
related to Inspiration amounted to (€56.2) million, against (€40.8)
million in 2011.
|
|
|
|
|
|
|
|
|
(in millions euros)
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011
|
- Cash flow before changes in working capital requirement
|
|
|
|
(3.5)
|
|
|
|
17.6
|
- Change in working capital related to discontinued activities
|
|
|
|
(17.3)
|
|
|
|
(10.9)
|
-
Net cash flow provided by discontinued activities
|
|
|
|
(20.8)
|
|
|
|
6.7
|
- Investment in intangible assets
|
|
|
|
(5.8)
|
|
|
|
-
|
- Convertible bond subscriptions
|
|
|
|
(26.7)
|
|
|
|
(45.3)
|
- Other cash flow related to investment activities
|
|
|
|
(2.9)
|
|
|
|
(2.2)
|
-
Net cash flow used in investing activities
|
|
|
|
(35,4)
|
|
|
|
(47.5)
|
-
Net cash flow used in financing activities
|
|
|
|
-
|
|
|
|
-
|
Change in cash and cash equivalents
|
|
|
|
(56.2)
|
|
|
|
(40.8)
|
This change in cash and cash equivalents from discontinued operations
included:
-
A net cash flow from discontinued activities of (€20.8) million
against €6.7 million in 2011, mainly composed of the regained OBI-1
commercial rights ($22.5 million) according to the renegotiation of
the partnership with Inspiration on 21 August 2012.
-
A use of fund of €35.4 million composed of the subscription by the
Group to a €26.7 million convertible bond issued by Inspiration and to
the acquisition of the IB1001 intangible asset for €6.1 million. In
2011, the Group had subscribed to two convertible bond issued by
Inspiration for €45.3 million. Also, in 2012, the Group recorded €2.9
million interest to be received on those obligations, against €2.2
million the previous year.
APPENDIX 1
|
-
Condensed consolidated income statement
|
(in million euros)
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011 (1)
|
|
|
|
|
|
|
|
|
|
Sales of goods
|
|
|
|
1 219.5
|
|
|
|
1 159.8
|
Other revenues
|
|
|
|
57.9
|
|
|
|
50.4
|
Revenue
|
|
|
|
1 277.4
|
|
|
|
1 210.2
|
Cost of goods sold
|
|
|
|
(254.8)
|
|
|
|
(249.2)
|
Research and development expenses
|
|
|
|
(248.6)
|
|
|
|
(234.6)
|
Selling expenses
|
|
|
|
(473.5)
|
|
|
|
(424.4)
|
General and administrative expenses
|
|
|
|
(99.1)
|
|
|
|
(99.7)
|
Other operating income
|
|
|
|
5.6
|
|
|
|
17.5
|
Other operating expenses
|
|
|
|
(25.8)
|
|
|
|
(17.6)
|
Amortisation of intangible assets
|
|
|
|
(5.8)
|
|
|
|
(7.8)
|
Restructuring costs
|
|
|
|
(63.1)
|
|
|
|
(36.5)
|
Impairment losses
|
|
|
|
2.4
|
|
|
|
(85.2)
|
Operating income
|
|
|
|
114.8
|
|
|
|
72.6
|
Investment income
|
|
|
|
1.0
|
|
|
|
1.6
|
Financing costs
|
|
|
|
(2.3)
|
|
|
|
(1.8)
|
Net financing costs
|
|
|
|
(1.3)
|
|
|
|
(0.2)
|
Other financial income and expense
|
|
|
|
6.8
|
|
|
|
(0.5)
|
Income taxes
|
|
|
|
(24.4)
|
|
|
|
1.9
|
Share of profit / loss from associated companies
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Net profit from continuing operations
|
|
|
|
95.8
|
|
|
|
73.8
|
|
|
|
|
|
|
|
|
|
Net profit from discontinued operations
|
|
|
|
(124.8)
|
|
|
|
(72.9)
|
|
|
|
|
|
|
|
|
|
Consolidated net profit
|
|
|
|
(29.0)
|
|
|
|
0.9
|
- Attributable to shareholders of Ipsen
|
|
|
|
(29.5)
|
|
|
|
0.4
|
- attributable to minority interests
|
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
|
|
|
|
|
|
Basic earnings per share, continuing operations (in euros)
|
|
|
|
1.15
|
|
|
|
0.88
|
Diluted earnings per share for continuing operations (in euros)
|
|
|
|
1.14
|
|
|
|
0.88
|
|
|
|
|
|
|
|
|
|
Basic earnings per share from discontinued operations (in euros)
|
|
|
|
(1.50)
|
|
|
|
(0.88)
|
Diluted earnings per share from discontinued operations (in euros)
|
|
|
|
(1.50)
|
|
|
|
(0.88)
|
|
|
|
|
|
|
|
|
|
Basic earnings per share (in euros)
|
|
|
|
(0.35)
|
|
|
|
0.01
|
Diluted earnings per share (in euros)
|
|
|
|
(0.35)
|
|
|
|
0.01
|
(1) In compliance with provisions on "discontinued activities",
2011 figures have been restated to provide comparative information
between 2011 and 2012 (see appendix 5)
|
|
APPENDIX 2
|
-
Condensed consolidated balance sheet
|
(in million euros)
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011
|
ASSETS
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
|
298.2
|
|
|
|
299.5
|
Other intangible assets
|
|
|
|
129.2
|
|
|
|
135.6
|
Property, plant & equipment
|
|
|
|
281.8
|
|
|
|
271.7
|
Equity investments
|
|
|
|
12
|
|
|
|
12.3
|
Investments in associated companies
|
|
|
|
0
|
|
|
|
-
|
Non-current financial assets
|
|
|
|
6.7
|
|
|
|
2.9
|
Other non-current assets
|
|
|
|
18.7
|
|
|
|
94
|
Deferred tax assets
|
|
|
|
208.2
|
|
|
|
184.6
|
Total non-current assets
|
|
|
|
954.7
|
|
|
|
1 000.6
|
Inventories
|
|
|
|
127.9
|
|
|
|
117.8
|
Trade receivables
|
|
|
|
256.3
|
|
|
|
259.4
|
Current tax assets
|
|
|
|
54.4
|
|
|
|
39.1
|
Other current assets
|
|
|
|
53.6
|
|
|
|
71.4
|
Current financial assets
|
|
|
|
0.5
|
|
|
|
-
|
Cash and cash equivalents
|
|
|
|
113.6
|
|
|
|
145
|
Assets from discontinued operations
|
|
|
|
-
|
|
|
|
-
|
Total current assets
|
|
|
|
606.3
|
|
|
|
632.8
|
TOTAL ASSETS
|
|
|
|
1 561.1
|
|
|
|
1 633.4
|
|
|
|
|
|
|
|
|
|
EQUITY AND LIABILITIES
|
|
|
|
|
|
|
|
|
Share capital
|
|
|
|
84.3
|
|
|
|
84.2
|
Additional paid-in capital and consolidated reserves
|
|
|
|
867.8
|
|
|
|
929.6
|
Net profit for the period
|
|
|
|
(29.5)
|
|
|
|
0.4
|
Exchange differences
|
|
|
|
1.6
|
|
|
|
(1.4)
|
Equity - attributable to shareholders of Ipsen
|
|
|
|
924.2
|
|
|
|
1 012.8
|
Attributable to minority interests
|
|
|
|
2
|
|
|
|
2.6
|
Total shareholders' equity
|
|
|
|
926.3
|
|
|
|
1 015.4
|
Retirement benefit obligation
|
|
|
|
19.9
|
|
|
|
19.5
|
Provisions
|
|
|
|
25.6
|
|
|
|
25.7
|
Short term debt
|
|
|
|
0
|
|
|
|
-
|
Other financial liabilities
|
|
|
|
15.9
|
|
|
|
16.6
|
Deferred tax liabilities
|
|
|
|
2.8
|
|
|
|
2.6
|
Other non-current liabilities
|
|
|
|
133.8
|
|
|
|
183.3
|
Total non-current liabilities
|
|
|
|
197.9
|
|
|
|
247.6
|
Provisions
|
|
|
|
66.2
|
|
|
|
24.5
|
Short term debt
|
|
|
|
4
|
|
|
|
4
|
Other financial liabilities
|
|
|
|
4.5
|
|
|
|
5
|
Accounts payable
|
|
|
|
159.8
|
|
|
|
149.8
|
Current tax liabilities
|
|
|
|
3.3
|
|
|
|
5.6
|
Other current liabilities
|
|
|
|
198.3
|
|
|
|
181.3
|
Bank overdrafts
|
|
|
|
0.4
|
|
|
|
0.2
|
Liabilities from discontinued operations
|
|
|
|
0.5
|
|
|
|
-
|
Total current liabilities
|
|
|
|
437
|
|
|
|
370.4
|
TOTAL EQUITY AND LIABILITIES
|
|
|
|
1 561.1
|
|
|
|
1 633.4
|
|
|
|
|
|
|
|
|
|
APPENDIX 3
|
-
Condensed consolidated cash flow statement
|
|
|
|
|
31 December 2012
|
|
|
|
31 December 2011
|
|
|
|
|
Continued activity
|
|
|
|
Discontinued activity
|
|
|
|
Total
|
|
|
|
Continued activity
|
|
|
|
Discontinued activity
|
|
|
|
Total
|
Consolidated net profit
|
|
|
|
95.8
|
|
|
|
(124.8)
|
|
|
|
(29.0)
|
|
|
|
73 763
|
|
|
|
(72 856)
|
|
|
|
907
|
Net profit/loss from discontinued operations
|
|
|
|
-
|
|
|
|
21.7
|
|
|
|
21.7
|
|
|
|
-
|
|
|
|
20.2
|
|
|
|
20.2
|
Share of profit/loss from associated companies
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
34.3
|
|
|
|
34.3
|
Net profit/loss from continuing operations before share of profit/loss
from associated companies
|
|
|
|
95.8
|
|
|
|
(103.2)
|
|
|
|
(7.4)
|
|
|
|
73.8
|
|
|
|
(18.4)
|
|
|
|
55.4
|
Non-cash and non-operating items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- Amortisation, provisions and impairment losses
|
|
|
|
72.6
|
|
|
|
-
|
|
|
|
72.6
|
|
|
|
71.1
|
|
|
|
1.0
|
|
|
|
72.0
|
- Impairment losses
|
|
|
|
(2.4)
|
|
|
|
125.4
|
|
|
|
123.1
|
|
|
|
85.2
|
|
|
|
42.0
|
|
|
|
127.2
|
- Change in fair value of derivative financial instruments
|
|
|
|
(2.5)
|
|
|
|
-
|
|
|
|
(2.5)
|
|
|
|
2.2
|
|
|
|
-
|
|
|
|
2.2
|
- Net gains or losses on disposals of non-current assets
|
|
|
|
1.9
|
|
|
|
-
|
|
|
|
1.9
|
|
|
|
4.6
|
|
|
|
-
|
|
|
|
4.6
|
- Share of government grants released to profit and loss
|
|
|
|
(0.1)
|
|
|
|
-
|
|
|
|
(0.1)
|
|
|
|
(0.1)
|
|
|
|
-
|
|
|
|
(0.1)
|
- Exchange differences
|
|
|
|
(1.4)
|
|
|
|
6.1
|
|
|
|
4.6
|
|
|
|
(2.3)
|
|
|
|
(6.1)
|
|
|
|
(8.4)
|
- Change in deferred taxes
|
|
|
|
6.9
|
|
|
|
(31.8)
|
|
|
|
(24.9)
|
|
|
|
(49.0)
|
|
|
|
(1.0)
|
|
|
|
(50.0)
|
- Share-based payment expense
|
|
|
|
4.6
|
|
|
|
-
|
|
|
|
4.6
|
|
|
|
4.1
|
|
|
|
-
|
|
|
|
4.1
|
- Gain/loss on sales of treasury shares
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
0.1
|
|
|
|
(0.1)
|
|
|
|
-
|
|
|
|
(0.1)
|
- Other non-cash items
|
|
|
|
(0.2)
|
|
|
|
-
|
|
|
|
(0.2)
|
|
|
|
0.2
|
|
|
|
-
|
|
|
|
0.2
|
Cash flow from operating activities before changes in working
capital requirement
|
|
|
|
175.3
|
|
|
|
(3.5)
|
|
|
|
171.8
|
|
|
|
189.5
|
|
|
|
17.6
|
|
|
|
207.1
|
- (Increase)/decrease in inventories
|
|
|
|
(7.1)
|
|
|
|
-
|
|
|
|
(7.1)
|
|
|
|
(5.1)
|
|
|
|
-
|
|
|
|
(5.1)
|
- (Increase)/decrease in trade receivables
|
|
|
|
10.1
|
|
|
|
-
|
|
|
|
10.1
|
|
|
|
(16.7)
|
|
|
|
-
|
|
|
|
(16.7)
|
- Increase/(decrease) in trade payables
|
|
|
|
15.0
|
|
|
|
-
|
|
|
|
15.0
|
|
|
|
9.4
|
|
|
|
-
|
|
|
|
9.4
|
- Change in income tax liability
|
|
|
|
(17.4)
|
|
|
|
-
|
|
|
|
(17.4)
|
|
|
|
4.7
|
|
|
|
-
|
|
|
|
4.7
|
- Net change in other operating assets and liabilities
|
|
|
|
(10.9)
|
|
|
|
(17.3)
|
|
|
|
(28.2)
|
|
|
|
(13.1)
|
|
|
|
(10.9)
|
|
|
|
(24.0)
|
Change in working capital related to operating activities
|
|
|
|
(10.3)
|
|
|
|
(17.3)
|
|
|
|
(27.6)
|
|
|
|
(20.7)
|
|
|
|
(10.9)
|
|
|
|
(31.6)
|
NET CASH FLOW PROVIDED BY OPERATING ACTIVITIES
|
|
|
|
165.0
|
|
|
|
(20.8)
|
|
|
|
144.2
|
|
|
|
168.8
|
|
|
|
6.7
|
|
|
|
175.4
|
Investment in property, plant & equipment
|
|
|
|
(49.0)
|
|
|
|
0.0
|
|
|
|
(49.0)
|
|
|
|
(44.3)
|
|
|
|
-
|
|
|
|
(44.3)
|
Investment in intangible assets
|
|
|
|
(27.7)
|
|
|
|
(6.1)
|
|
|
|
(33.8)
|
|
|
|
(58.0)
|
|
|
|
-
|
|
|
|
(58.0)
|
Proceeds from disposal of intangible assets and property, plant &
equipment
|
|
|
|
0.3
|
|
|
|
0.3
|
|
|
|
0.6
|
|
|
|
7.0
|
|
|
|
-
|
|
|
|
7.0
|
Acquisition of shares in non-consolidated companies
|
|
|
|
(0.4)
|
|
|
|
-
|
|
|
|
(0.4)
|
|
|
|
(5.7)
|
|
|
|
-
|
|
|
|
(5.7)
|
Convertible bond subscriptions
|
|
|
|
(0.2)
|
|
|
|
(26.7)
|
|
|
|
(26.9)
|
|
|
|
-
|
|
|
|
(45.3)
|
|
|
|
(45.3)
|
Proceeds of financial assets
|
|
|
|
13.9
|
|
|
|
-
|
|
|
|
13.9
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
Payments to post-employment benefit plans
|
|
|
|
(6.1)
|
|
|
|
-
|
|
|
|
(6.1)
|
|
|
|
(2.0)
|
|
|
|
-
|
|
|
|
(2.0)
|
Other cash flow related to investment activities
|
|
|
|
(0.5)
|
|
|
|
(2.9)
|
|
|
|
(3.4)
|
|
|
|
(0.7)
|
|
|
|
(2.2)
|
|
|
|
(2.9)
|
Deposits
|
|
|
|
(0.4)
|
|
|
|
-
|
|
|
|
(0.4)
|
|
|
|
(0.1)
|
|
|
|
-
|
|
|
|
(0.1)
|
Change in working capital related to investing activities
|
|
|
|
5.3
|
|
|
|
-
|
|
|
|
5.3
|
|
|
|
8.0
|
|
|
|
-
|
|
|
|
8.0
|
NET CASH USED IN INVESTING ACTIVITIES
|
|
|
|
(64.8)
|
|
|
|
(35.4)
|
|
|
|
(100.2)
|
|
|
|
(95.7)
|
|
|
|
(47.5)
|
|
|
|
(143.2)
|
Repayment of long-term borrowings
|
|
|
|
(0.3)
|
|
|
|
-
|
|
|
|
(0.3)
|
|
|
|
(0.3)
|
|
|
|
0.0
|
|
|
|
(0.3)
|
Capital increase by Ipsen
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
0.1
|
Treasury shares
|
|
|
|
0.2
|
|
|
|
-
|
|
|
|
0.2
|
|
|
|
1.0
|
|
|
|
-
|
|
|
|
1.0
|
Dividends paid by Ipsen
|
|
|
|
(66.5)
|
|
|
|
-
|
|
|
|
(66.5)
|
|
|
|
(66.5)
|
|
|
|
-
|
|
|
|
(66.5)
|
Dividends paid by subsidiaries to minority interests
|
|
|
|
(1.0)
|
|
|
|
-
|
|
|
|
(1.0)
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
Deposits
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
"DIP" financing
|
|
|
|
(7.2)
|
|
|
|
-
|
|
|
|
(7.2)
|
|
|
|
0.0
|
|
|
|
-
|
|
|
|
0.0
|
Change in working capital related to financing activities
|
|
|
|
1.6
|
|
|
|
-
|
|
|
|
1.6
|
|
|
|
0.6
|
|
|
|
-
|
|
|
|
0.6
|
NET CASH USED IN FINANCING ACTIVITIES
|
|
|
|
(73.2)
|
|
|
|
-
|
|
|
|
(73.2)
|
|
|
|
(65.2)
|
|
|
|
-
|
|
|
|
(65.2)
|
CHANGE IN CASH AND CASH EQUIVALENTS
|
|
|
|
27.0
|
|
|
|
(56.2)
|
|
|
|
(29.2)
|
|
|
|
7.9
|
|
|
|
(40.8)
|
|
|
|
(32.9)
|
Opening cash and cash equivalents
|
|
|
|
144.8
|
|
|
|
-
|
|
|
|
144.8
|
|
|
|
177.9
|
|
|
|
-
|
|
|
|
177.9
|
Impact of exchange rate fluctuations
|
|
|
|
(2.3)
|
|
|
|
-
|
|
|
|
(2.3)
|
|
|
|
(0.2)
|
|
|
|
-
|
|
|
|
(0.2)
|
Closing cash and cash equivalents
|
|
|
|
169.5
|
|
|
|
(56.2)
|
|
|
|
113.3
|
|
|
|
185.6
|
|
|
|
(40.8)
|
|
|
|
144.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
APPENDIX 4
|
-
Reconciliation between the income statement at 31 December
2012 and the recurring adjusted income statement at 31 December
2012
|
|
|
|
|
31 December 2012 restated
|
|
|
|
Assets from discontinued operations (1)
|
|
|
|
Other non-recurring items(2)
|
|
|
|
31 December 2011
|
(in million euros)
|
|
|
|
|
|
|
|
% Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% Sales
|
Revenue
|
|
|
|
1 277.4
|
|
|
|
104.7%
|
|
|
|
|
|
|
|
|
|
|
|
1 277.4
|
|
|
|
104.7%
|
Cost of goods sold
|
|
|
|
(254.8)
|
|
|
|
-20.9%
|
|
|
|
|
|
|
|
|
|
|
|
(254.8)
|
|
|
|
-20.9%
|
Research and development expenses
|
|
|
|
(248.6)
|
|
|
|
-20.4%
|
|
|
|
|
|
|
|
|
|
|
|
(248.6)
|
|
|
|
-20.4%
|
Selling expenses
|
|
|
|
(473.5)
|
|
|
|
-38.8%
|
|
|
|
|
|
|
|
|
|
|
|
(473.5)
|
|
|
|
-38.8%
|
General and administrative expenses
|
|
|
|
(99.1)
|
|
|
|
-8.1%
|
|
|
|
|
|
|
|
|
|
|
|
(99.1)
|
|
|
|
-8.1%
|
Other operating income
|
|
|
|
5.6
|
|
|
|
0.5%
|
|
|
|
|
|
|
|
|
|
|
|
5.6
|
|
|
|
0.5%
|
Other operating expenses
|
|
|
|
(7.8)
|
|
|
|
-0.6%
|
|
|
|
|
|
|
|
(18.0)
|
|
|
|
(25.8)
|
|
|
|
-2.1%
|
Amortisation of intangible assets
|
|
|
|
(3.3)
|
|
|
|
-0.3%
|
|
|
|
|
|
|
|
(2.5)
|
|
|
|
(5.8)
|
|
|
|
-0.5%
|
Restructuring costs
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
(63.1)
|
|
|
|
(63.1)
|
|
|
|
-5.2%
|
Impairment losses
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
2.4
|
|
|
|
2.4
|
|
|
|
0.2%
|
Operating income
|
|
|
|
196.0
|
|
|
|
16.1%
|
|
|
|
|
|
|
|
(81.2)
|
|
|
|
114.8
|
|
|
|
9.4%
|
Financial income/(expense)
|
|
|
|
(6.5)
|
|
|
|
-0.5%
|
|
|
|
|
|
|
|
11.9
|
|
|
|
5.5
|
|
|
|
0.4%
|
Income taxes
|
|
|
|
(44.0)
|
|
|
|
-3.6%
|
|
|
|
|
|
|
|
19.6
|
|
|
|
(24.4)
|
|
|
|
-2.0%
|
Share of profit/loss from associated companies
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
Net profit from continuing operations
|
|
|
|
145.5
|
|
|
|
11.9%
|
|
|
|
|
|
|
|
(49.7)
|
|
|
|
95.8
|
|
|
|
7.9%
|
Profit from discontinued operations
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(124.8)
|
|
|
|
|
|
|
|
(124.8)
|
|
|
|
-10.2%
|
Consolidated net profit
|
|
|
|
145.5
|
|
|
|
11.9%
|
|
|
|
(124.8)
|
|
|
|
(49.7)
|
|
|
|
(29.0)
|
|
|
|
-2.4%
|
- attributable to shareholders of Ipsen S.A.
|
|
|
|
145.0
|
|
|
|
-
|
|
|
|
(124.8)
|
|
|
|
(49.7)
|
|
|
|
(29.5)
|
|
|
|
-
|
- attributable to minority interests
|
|
|
|
0.5
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
0.5
|
|
|
|
-
|
Diluted earnings per share (in euros)
|
|
|
|
1.74
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.35)
|
|
|
|
|
(1) Income statement impact linked to Inspiration
Biopharmaceuticals Inc.
(2) Other non-recurring items include:
-
non-recurring fees incurred during the preparation and early
implementation of the strategy announced on 9 June 2011
-
non-recurring expenses linked with restructuring corresponding to the
transfer of the Group's North American commercial subsidiary to the
East Coast
-
the settlement of a trade dispute with a partner
-
an administrative proceeding towards the Group
-
and proceed on disposal of PregLem shares
-
non-recurring tax elements
-
Reconciliation between the income statement at 31 December
2011 and the recurring adjusted income statement at 31 December
2011
|
|
|
|
|
31 December 2011 Proforma Recurring
Adjusted
|
|
|
|
Assets from discontinued operations (1)
|
|
|
|
Impairment
(2)
|
|
|
|
Other non- recurring items(2)
|
|
|
|
31 December 2011 Proforma
|
(in million euros)
|
|
|
|
|
|
|
|
% Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% Sales
|
Revenue
|
|
|
|
1 210.2
|
|
|
|
104.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 210.2
|
|
|
|
104.3%
|
Cost of goods sold
|
|
|
|
(249.2)
|
|
|
|
-21.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(249.2)
|
|
|
|
-21.5%
|
Research and development expenses
|
|
|
|
(234.6)
|
|
|
|
-20.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(234.6)
|
|
|
|
-20.2%
|
Selling expenses
|
|
|
|
(424.4)
|
|
|
|
-36.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(424.4)
|
|
|
|
-36.6%
|
General and administrative expenses
|
|
|
|
(99.7)
|
|
|
|
-8.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(99.7)
|
|
|
|
-8.6%
|
Other operating income
|
|
|
|
0.4
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
17.2
|
|
|
|
17.5
|
|
|
|
1.5%
|
Other operating expenses
|
|
|
|
(0.4)
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
(17.3)
|
|
|
|
(17.6)
|
|
|
|
-1.5%
|
Amortisation of intangible assets
|
|
|
|
(4.7)
|
|
|
|
-0.4%
|
|
|
|
|
|
|
|
|
|
|
|
(3.1)
|
|
|
|
(7.8)
|
|
|
|
-0.7%
|
Restructuring costs
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
(36.5)
|
|
|
|
(36.5)
|
|
|
|
-3.2%
|
Impairment losses
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
(85.2)
|
|
|
|
|
|
|
|
(85.2)
|
|
|
|
-7.3%
|
Operating income
|
|
|
|
197.5
|
|
|
|
17.0%
|
|
|
|
|
|
|
|
(85.2)
|
|
|
|
(39.7)
|
|
|
|
72.6
|
|
|
|
6.3%
|
Financial income/(expense)
|
|
|
|
(0.7)
|
|
|
|
-0.1%
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(0.7)
|
|
|
|
-0.1%
|
Income taxes
|
|
|
|
(43.1)
|
|
|
|
-3.7%
|
|
|
|
|
|
|
|
32.3
|
|
|
|
12.7
|
|
|
|
1.9
|
|
|
|
0.2%
|
Share of profit/loss from associated companies
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
Net profit from continuing operations
|
|
|
|
153.7
|
|
|
|
13.3%
|
|
|
|
|
|
|
|
(52.9)
|
|
|
|
(27.0)
|
|
|
|
73.8
|
|
|
|
6.4%
|
Profit from discontinued operations
|
|
|
|
0.7
|
|
|
|
-1.0%
|
|
|
|
(73.5)
|
|
|
|
|
|
|
|
|
|
|
|
(72.9)
|
|
|
|
-6.3%
|
Consolidated net profit
|
|
|
|
154.4
|
|
|
|
12.2%
|
|
|
|
(73.5)
|
|
|
|
(52.9)
|
|
|
|
(27.0)
|
|
|
|
0.9
|
|
|
|
0.1%
|
- attributable to shareholders of Ipsen S.A.
|
|
|
|
153.9
|
|
|
|
|
|
|
|
(73.5)
|
|
|
|
(52.9)
|
|
|
|
(27.0)
|
|
|
|
0.4
|
|
|
|
|
- attributable to minority interests
|
|
|
|
0.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.5
|
|
|
|
|
Diluted earnings per share (in euros)
|
|
|
|
1.86
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.01
|
|
|
|
|
(1) The 2011 presentation is compliant with IFRS5: 2011 has
been restated to provide a comparative information between 2011 and 2012
(see appendix5).
(2) Impairment booked over the period 2012 (details in note
« Impaiment »
(3) Other non-recurring items include:
-
non-recurring fees incurred during the preparation and early
implementation of the strategy announced on 9 June 2011
-
impact related to allocation of purchase price acquisition on North
America transactions
-
non-recurring expenses linked with restructuring corresponding to the
transfer of the Group's North American commercial subsidiary to the
East Coast
-
the settlement of a trade dispute with a partner
-
an administrative proceeding towards the Group
APPENDIX 5
|
-
Reconciliation between the income statement at 31 December
2011 as published and the income statement proforma at 31
December 2011
|
|
|
|
|
31 December 2011 Proforma
|
|
|
|
Restatements according to IFRS 5
|
|
|
|
31 December 2011 As published
|
(in million euros)
|
|
|
|
|
|
|
|
% sales
|
|
|
|
|
|
|
|
|
|
|
% sales
|
Revenue
|
|
|
|
1 210.2
|
|
|
|
104.3%
|
|
|
|
(24.7)
|
|
|
|
1 234.9
|
|
|
|
106.5%
|
Cost of goods sold
|
|
|
|
(249.2)
|
|
|
|
-21.5%
|
|
|
|
-
|
|
|
|
(249.2)
|
|
|
|
-21.5%
|
Research and development expenses
|
|
|
|
(234.6)
|
|
|
|
-20.2%
|
|
|
|
19.0
|
|
|
|
(253.6)
|
|
|
|
-21.9%
|
Selling expenses
|
|
|
|
(424.4)
|
|
|
|
-36.6%
|
|
|
|
0.7
|
|
|
|
(425.2)
|
|
|
|
-36.7%
|
General and administrative expenses
|
|
|
|
(99.7)
|
|
|
|
-8.6%
|
|
|
|
1.8
|
|
|
|
(101.5)
|
|
|
|
-8.7%
|
Other operating income
|
|
|
|
17.5
|
|
|
|
1.5%
|
|
|
|
-
|
|
|
|
17.5
|
|
|
|
1.5%
|
Other operating expenses
|
|
|
|
(17.6)
|
|
|
|
-1.5%
|
|
|
|
-
|
|
|
|
(17.6)
|
|
|
|
-1.5%
|
Amortisation of intangible assets
|
|
|
|
(7.8)
|
|
|
|
-0.7%
|
|
|
|
-
|
|
|
|
(7.8)
|
|
|
|
-0.7%
|
Restructuring costs
|
|
|
|
(36.5)
|
|
|
|
-3.2%
|
|
|
|
-
|
|
|
|
(36.5)
|
|
|
|
-3.2%
|
Impairment losses
|
|
|
|
(85.2)
|
|
|
|
-7.3%
|
|
|
|
-
|
|
|
|
(85.2)
|
|
|
|
-7.3%
|
Operating income
|
|
|
|
72.6
|
|
|
|
6.3%
|
|
|
|
(3.2)
|
|
|
|
75.8
|
|
|
|
6.5%
|
Financial income/(expense)
|
|
|
|
(0.7)
|
|
|
|
-0.1%
|
|
|
|
33.7
|
|
|
|
(34.4)
|
|
|
|
-3.0%
|
Income taxes
|
|
|
|
1.9
|
|
|
|
0.2%
|
|
|
|
(11.5)
|
|
|
|
13.3
|
|
|
|
1.2%
|
Share of profit/loss from associated companies
|
|
|
|
-
|
|
|
|
-
|
|
|
|
54.5
|
|
|
|
(54.5)
|
|
|
|
-4.7%
|
Net profit from continuing operations
|
|
|
|
73.8
|
|
|
|
6.4%
|
|
|
|
73.5
|
|
|
|
0.2
|
|
|
|
0.0%
|
Profit from discontinued operations
|
|
|
|
(72.9)
|
|
|
|
-6.3%
|
|
|
|
(73.5)
|
|
|
|
0.7
|
|
|
|
0.1%
|
Consolidated net profit
|
|
|
|
0.9
|
|
|
|
0.1%
|
|
|
|
-
|
|
|
|
0.9
|
|
|
|
0.1%
|
- attributable to shareholders of Ipsen S.A.
|
|
|
|
0.4
|
|
|
|
|
|
|
|
|
|
|
|
0.4
|
|
|
|
|
- attributable to minority interests
|
|
|
|
0.5
|
|
|
|
|
|
|
|
|
|
|
|
0.5
|
|
|
|
|
Diluted earnings per share (in euros)
|
|
|
|
0.01
|
|
|
|
|
|
|
|
|
|
|
|
0.01
|
|
|
|
|
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