[February 28, 2014] |
|
Ipsen's 2013 results and 2014 financial objectives
PARIS --(Business Wire)--
Regulatory News :
The Board of Directors of Ipsen (Euronext: IPN; ADR: IPSEY), chaired by
Marc de Garidel, met on 27 February 2014 to review the Group's results
for 2013, 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 2013 and 2012 restated3
(in million euros)
|
|
2013
|
|
2012 restated3
|
|
% change
|
|
Drug sales
|
|
1,191.3
|
|
1,187.0
|
|
+2.1%4
|
|
Sales
|
|
1,224.8
|
|
1,219.5
|
|
+2.2%4
|
|
Total revenues
|
|
1,281.8
|
|
1,277.4
|
|
+0.3%
|
|
Operating profit
|
|
190.7
|
|
117.1
|
|
+62.9%
|
|
Operating margin2
|
|
15.6%
|
|
9.6%
|
|
-
|
|
Recurring adjusted1 operating profit
|
|
208.6
|
|
198.3
|
|
+5.2%
|
|
Recurring adjusted1 operating margin2
|
|
17.0%
|
|
16.3%
|
|
-
|
|
Consolidated profit
|
|
153.1
|
|
(27.5)
|
|
N/A
|
|
Earnings per share - fully diluted (€)
|
|
1.83
|
|
(0.33)
|
|
N/A
|
|
Recurring adjusted1 consolidated profit
|
|
154.0
|
|
147.1
|
|
+4.7%
|
|
Recurring adjusted1 EPS - fully diluted
(€)
|
|
1.85
|
|
1.76
|
|
+5.1%
|
|
Weighted average number of shares:
|
|
|
|
|
|
|
|
Outstanding
|
|
83,029,957
|
|
83,155,604
|
|
-
|
|
Fully diluted
|
|
83,163,230
|
|
83,460,232
|
|
-
|
|
Commenting the 2013 performance, Marc de Garidel, Chairman and Chief
Executive Officer of Ipsen, stated: "2013 results highlight
the improvement of the Group's operating result in the last two years
and reflect the past restructuring efforts. The recurring adjusted1
operating margin reached 17%2, above
expectations. From a clinical standpoint, 2013 was marked by important
results for Dysport® and Somatuline®. Marc
de Garidel added: "In 2014, the Group intends to accelerate
specialty care growth and is preparing for the US launch of Somatuline®
in NET and the tasquinimod phase III results in prostate cancer."
1 "Recurring adjusted": reconciliations between results and
recurring adjusted results for 2013 and 2012 are detailed in appendix 4
2 In % of sales
3 For purposes of comparison between the two financial years,
the 2012 income statement has been restated in accordance with IAS 19
revised (see appendix 5)
4 Sales growth excluding foreign exchange impact, calculated
by applying the average 2013 rates to 31 December 2012 sales figures
Comparison between the Group's 2013 performance and its
financial objectives
|
|
|
|
Initial financial
|
|
Revised financial
|
|
Realized in 2013
|
|
|
|
objectives(1)
|
|
objectives(2)
|
|
|
|
Specialty care drug sales
|
|
[+6% ; +8%]3
|
|
Around +3.0%3
|
|
+3.0%3
|
|
Primary care drug sales
|
|
[-8% ; -6%]3
|
|
Around -1.0%3
|
|
-0.1%3
|
|
Recurring adjusted4 operating margin
|
|
Around 16.0% of sales
|
|
Around 16.0% of sales
|
|
17.0% of sales
|
|
Review of full year 2013 results
In 2013, Group drug sales grew 2.1% year-on-year excluding
foreign exchange impact3 or 0.4% at current exchange rate.
Consolidated Group sales reached €1,224.8 million in 2013, up
2.2% year-on-year excluding foreign exchange impact3.
Other revenues reached €57.0 million in 2013, down 1.5% compared
to €57.9 million in 2012. In 2013, the Group recorded revenues of €17.7
million, compared with €20.9 million the previous year, notably arising
from the Group's co-promotion and co-marketing agreements in France. In
2013, except for residual compensation paid to Ipsen by Novartis, this
line item no longer included revenues from Exforge®,
following the April 2012 termination of the co-promotion agreement with
Novartis in France. Royalties received amounted to €15.3 million in
2013, up €3.4 million year-on-year, driven by the increase in royalties
paid by Group partners.
Total revenues amounted to €1,281.8 million in 2013, up 0.3%
compared with 2012.
Cost of goods sold amounted to €253.4 million, representing 20.7%
of sales, compared with 20.9% of sales in 2012. The improvement in cost
of goods sold stemmed notably from a favourable product mix and
increased productivity efforts, partially offset by higher custom
duties, as a result of the Group's increased business activity in
certain countries and the decline in primary care volumes.
Research and development expenses represented €259.1 million in
2013, up 4.4% year-on-year, mainly driven by the major programmes
conducted during the period on Dysport® (spasticity of the
lower and upper limbs), tasquinimod and Somatuline®.
Industrial and pharmaceutical development costs were stable between 2013
and 2012. These expenses notably included costs related to the
validation of the tasquinimod manufacturing process, to the on-going
rollout of a development platform for toxins, and to the work on a
ready-to-use, liquid formulation for Dysport® (Dysport®
Next Generation).
Selling, general and administrative expenses amounted to €555.1
million in 2013, representing 45.3% of sales, down 1.6% versus 2012.
Royalties paid to third parties on sales of products marketed by the
Group totalled €51.9 million in 2013, up 0.4% year-on-year, driven by
improved in-market sales of in-licensed products. Other sales and
marketing expenses amounted to €399.3 million, or 32.6% of sales, down
5.2% compared with 2012. The decline stemmed from the restructuring of
both the French primary care sales force and the US sales force. General
and administrative expenses grew 4.8% in 2013, notably as a result of
actions taken to accelerate the execution of the Group's strategy and of
a step-up in tax measures in France.
1 2013 initial guidance issued on 27 February 2013
2 2013 updated guidance communicated on 30 August 2013
3 Sales growth excluding foreign exchange impact, calculated
by applying the average 2013 rates to o 31 December 2012 sales figures
4 "Recurring adjusted": reconciliations between results and
recurring adjusted results for 2013 and 2012 are detailed in appendix 4
Reported operating income in 2013 amounted to €190.7 million, up
62.9% year-on-year, notably affected by:
-
Other operating income and expenses. Other operating income,
which primarily included revenue from the sublease of Ipsen's
headquarters building, amounted to €5.7 million. Other operating
expenses amounted to €12.0 million, down from €25.8 million the
previous year. Other operating expenses primarily included
non-recurring costs related to the acquisition of Syntaxin Ltd., the
reorganisation of the US subsidiary, the settlement of a trade dispute
with a partner, an administrative proceeding brought against the
Group, as well as headquarters rental costs.
-
Amortisation of intangible assets (excluding software),
represented a €4.4 million charge, compared to €5.8 million the
previous year. The decrease is mainly due to the discontinuation of
the IGF-1 license amortisation, following the new impairment loss
recognised at 30 June 2013 (see impairment losses paragraph) and the
complete amortisation of Exforge® (termination of the
co-promotion agreement with Novartis in France effective 30 April
2012).
-
Restructuring costs, which amounted to €0.2 million in
non-recurring costs, mainly arising from the reversal of an accrual
related to the primary care restructuring plan in France, offset by
restructuring costs in the US (non-recurring costs of €4.1 million,
which primarily included compensation-related expenses for the early
termination of employment contracts) and by costs incurred by the
Group to accelerate the implementation of transformation initiated in
2011, that aims at adapting the Group's operating structures to future
challenges. In 2013, these costs were mainly related to measures taken
to adjust resources in certain geographies following the
implementation of the new strategy, the transformation and
reorganization of Research and Development activities and the
adjustment of support functions.
-
Impairment losses, which represented a non-recurring charge of
€12.6 million. In view of the supply interruption and the uncertainty
about the date of re-supply in the US, the Group recognised a
non-recurring €11.6 million impairment loss on the Increlex®
IGF-1 asset at 30 June 2013. With this impairment loss, the carrying
value of the IGF-1 active ingredient became zero. Ipsen also
recognised a €1.0 million impairment loss following a decision by the
Group not to exercise its right to develop a neurology programme.
Excluding purchase price allocation impacts, non-recurring restructuring
costs and impairment charges, the Group's recurring adjusted1
operating income amounted to €208.6 million, or 17.0% of
consolidated sales, up 5.2% year-on-year.
Net financing costs represented a €5.8 million income, compared
to a €1.3 million expense the previous year. The net income mainly
resulted from a financial gain on the repayment of the
Debtor-in-Possession (DIP) financing granted by Ipsen to Inspiration
Biopharmaceuticals Inc. at the end of 2012, following the sale of its
hemophilia assets to Baxter and Cangene.
Other financial income and expenses amounted to a €14.8 million
charge at 31 December 2013. The expense primarily arose from a negative
€11.2 million foreign exchange impact and a €2.0 million depreciation
charge on convertible bonds subscribed by the Group to develop a
neurology programme. At 31 December 2012, the Group recognised other
financial income of €6.8 million, resulting from an unfavourable
exchange rate impact, additional payments received on its sale of
PregLem Holdings SA shares in 2010, and a profit from the sale of shares
in Spirogen Plc during the year.
The Group effective tax rate was 21.8% of profit before tax from
continuing operations in 2013, compared with 20.6% in 2012. Excluding
non-recurring operating, financial and fiscal items, the Group's
effective tax rate amounted to 20.6% in 2013, compared with 23.3% in
2012.
1 "Recurring adjusted": reconciliations between results and
recurring adjusted results for 2013 and 2012 are detailed in appendix 4
Net profit from continuing operations amounted to €142.2 million
at 31 December 2013, up 46.0% from the €97.4 million posted at 31
December 2012.
Net profit from discontinued operations amounted to €10.9 million
at 31 December 2013, compared with a net loss of €124.8 million in 2012.
It primarily comprises:
-
the rebilling to Baxter of production costs for OBI-1 clinical samples
prior to the effective transfer of the production site and staff,
-
the negotiated repayment of advisory fees paid by Ipsen during the
joint asset-sale process with Inspiration Biopharmaceuticals Inc.,
-
the tax impact related to the compensation paid by the Group to the US
subsidiary that sold the assets.
Consolidated net profit in 2013 was €153.1 million (€152.5
million attributable to Ipsen S.A. shareholders), compared to a €27.5
million consolidated net loss (€27.9 million loss attributable to Ipsen
S.A shareholders) in 2012.
At 31 December 2013, recurring adjusted1
profit from continuing operations amounted to €154.0 million, up
4.7% from €147.1 million a year earlier.
Net cash generated by operating activities from continuing operations amounted
to €181.4 million in 2013, up €16.4 million year-on-year. Total net cash
generated by operating activities amounted to €188.1 million in 2013, up
30.4% year-on-year. At 31 December 2013, the Group had a positive net
cash position2 of €125.4 million euros, compared
with a positive net cash position of €113.3 million euros in 2012.
Dividend for the 2013 financial year proposed
for the approval of Ipsen's shareholders
Ipsen's Board of Directors, which met on 27 February 2014, has decided
to propose at Ipsen's annual shareholders' meeting to be held on 4 June
2014 the payment of a dividend of €0.80 per share, stable year-on-year,
representing a pay-out ratio of approximately 44% of recurring adjusted1
consolidated net profit (attributable to the Group's shareholders),
compared to a pay-out ratio of approximately 46% for the 2012 financial
year.
2014 financial objectives
Based on information currently available, the Group has set the
following financial targets for 2014:
-
Specialty Care drug sales growth year-on-year between 4.0%
and 6.0%, driven by normalization of situation in the China, in a
context of continued pricing pressure and uncertainty on Increlex®
US resupply ;
-
Primary Care drug sales decline year-on-year between -2.0%
and 0.0%, excluding the launch of a Smecta® generic in
France ;
-
Recurring adjusted1 operating margin
between [16.0%; 17.0%] of sales. In 2014, Ipsen will continue to
implement operating efficiency measures. The Group notably strives to
limit the profitability impact of launching Somatuline® NET
in the US.
The above objectives are set at constant currency and exclude major
negative unforeseeable events, for instance the deterioration in the
economic environment in Ukraine.
1 "Recurring adjusted": reconciliations between results and
recurring adjusted results for 2013 and 2012 are detailed in appendix 4
2 Net cash and cash equivalents: cash and cash equivalents
after deduction of bank overdrafts
Press conference (in French)
Ipsen will host a press conference on Friday 28 February 2013 at 9:00
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 Friday 28 February 2014 at 14:30
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 reference for the conference is ID 941674. Phone numbers to
call in order to connect to the conference are: from France and
continental Europe +33 (0)17 0993 213, from UK +44 (0)207 0389 482 and
from the United States +1 646 461 1771. 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)17 0993 213, from UK +44 (0)207 0389 482 and from the
United States +1 646 461 1771 and access code is 941674. 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 2013. Ipsen's ambition is to become a
leader in specialty healthcare solutions for targeted debilitating
diseases. Its development strategy is supported by 3 franchises:
neurology, endocrinology and uro-oncology. 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
2013, R&D expenditure totaled close to €260 million, representing more
than 21% of Group sales. Moreover, Ipsen also has a significant presence
in primary care. The Group has close to 4,600 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 2012
Registration Document available on its website www.ipsen.com.
-
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 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.
-
The Group depends on third parties to develop and market some of its
products, which generates or may generate substantial royalties for
the Group, but these third parties could behave in ways that cause
damage to the Group's business. The Group cannot be certain that its
partners will fulfill their obligations. It might be unable to obtain
any benefit from those agreements. A default by any of the Group's
partners could generate lower revenues than expected. Such situations
could have a negative impact on the Group's business, financial
position or performance.
-
Actual results may depart significantly from the objectives given that
a new product can appear to be promising at a development stage, or
after clinical trials, but never be launched on the market, or be
launched on the market but fail to sell, notably for regulatory or
competitive reasons.
-
The Research and Development process typically lasts between eight and
twelve years from the date of 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.
-
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, such as Forlax® and 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
in the Group losing market share which could affect its current level
of growth in sales or profitability.
-
Third parties might claim the benefit of intellectual property rights
with respect to the Group's inventions. The Group provides the third
parties with which it collaborates (including universities and other
public or private entities) with information and data in various forms
relating to the research, development, manufacturing and marketing of
its products. Despite the precautions taken by the Group with regard
to these entities, in particular of a contractual nature, they (or
certain of their members or affiliates) could claim ownership of
intellectual property rights arising from the trials carried out by
their employees or any other intellectual property right relating to
the Group's products or molecules in development.
-
The Group's strategy includes acquiring companies or assets which may
enable or facilitate access to new markets, research projects or
geographical regions or enable the Group 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.
-
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 experiencing
manufacturing issues with Increlex®. Supply interruption
occurred in mid-June 2013 in the US and in Q3 2013 in Europe and the
rest of the world. On December 18th 2013, Ipsen announced
that Lonza had successfully re-manufactured the active ingredient of
Increlex® and that the European Medicines Agency (EMA) had
been informed that Ipsen was preparing for the resupply of Increlex®
in the European Union. Consultations with the National competent
authorities have allowed a resupply in Europe early 2014. Resupply in
the US is still pending. Ipsen is actively working with its third
party manufacturer and the Food and Drug Administration (FDA) to bring
Increlex® back to the US market as soon as possible.
-
In certain countries exposed to significant public deficits, and where
the Group sells its drugs directly to public hospitals, the Group
could face discount or lengthened payment terms or difficulties in
recovering its receivables in full. The Group closely monitors the
evolution of the situation in Southern Europe where hospital payment
terms are especially long. More generally, the Group may also be
unable to purchase sufficient credit insurance to protect itself
adequately against the risk of payment default from certain customers
worldwide. Such situations could negatively impact the Group's
activities, financial situation and results.
-
In the normal course of business, the Group is or may be involved in
legal or administrative proceedings. Financial claims are or may be
brought against the Group in connection with some of these
proceedings. 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.
-
The cash pooling arrangements for foreign subsidiaries outside the
euro zone expose the Group to financial foreign exchange risk. The
variation of these exchange rates may impact significantly the Group's
results.
Major developments in 2013
During 2013, 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) announced that they entered into an Asset Purchase
Agreement (APA) whereby Baxter International (Baxter) agree 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 that 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 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.
-
On 27 February 2013 - Ipsen's Board of Directors appointed Christel
Bories as Deputy Chief Executive Officer. This appointment will be
effective as of 1 March 2013. Working alongside Marc de Garidel,
Chairman and Chief Executive Officer, Christel Bories will be
responsible for accelerating the execution of the Group's strategy.
-
On 21 March 2013 - Ipsen and Inspiration Biopharmaceuticals Inc.
(Inspiration) announced the closing of the sale of its lead hemophilia
program, OBI-1 to Baxter International Inc. (Baxter), the global
leader in hemophilia. Baxter acquired worldwide rights to OBI-1, a
recombinant porcine factor VIII in development for the treatment of
congenital hemophilia A with inhibitors and acquired hemophilia A, as
well as Ipsen's manufacturing facility for OBI-1 in Milford, MA. The
Ipsen employees working on the development and manufacturing of OBI-1
were offered employment by Baxter. Baxter has agreed to pay $50
million upfront, up to $135 million in potential additional
development and sales milestones as well as tiered net sales payments
ranging from 12.5% to 17.5% of OBI-1 global net sales. OBI-1 is
currently in a pivotal trial for the treatment of individuals with
acquired hemophilia A. As Inspiration's only senior secured creditor
and as the owner of non-Inspiration assets that will be included in
the sale of both OBI-1 and IB1001, Ipsen will receive at least 60% of
the upfront payments. Over and above these upfront amounts, Ipsen will
receive 80% of all payments up to a present value of $304 million and
50% of all proceeds thereafter.
-
On 9 April 2013 - Ipsen announced that Health Canada had granted a
marketing authorization for Dysport® (Botulinum toxin type
A for injection) for the temporary improvement in the appearance of
moderate to severe frown lines (glabellar lines) in adult patients
younger than 65 years of age. Medicis Aesthetics Canada, a division of
Valeant Pharmaceuticals, will market Dysport® for use in
aesthetic medicine in Canada.
-
On 10 April 2013 - PeptiDream Inc., a Tokyo-based pharmaceutical
company (PeptiDream), and Ipsen, a global specialty driven
pharmaceutical Group, announced that they have entered into a research
collaboration and license option agreement to discover, evaluate,
potentially develop and launch therapeutic peptides to treat serious
medical conditions in areas of therapeutic focus for Ipsen.
-
On 24 April 2013 - Upon proposal of the Appointments and Governance
Committee, the Board of Directors of Ipsen will propose to the
Combined Shareholders' Meeting to be held on 31 May 2013 the renewal
of the terms of office as Directors of Mr. Antoine Flochel and Mr.
Gérard Hauser and the appointment as a Director of Mrs. Martha
Crawford in replacement of Mr. Klaus-Peter Schwabe who did not request
the renewal of his term of office.
-
On 25 April 2013 - Ipsen announced that the supplier of Increlex®'s
(mecasermin [rDNA origin] Injection) active ingredient, Lonza, was
facing manufacturing issues with Increlex® at its Hopkinton
site (MA, USA). The supply interruption occurred in mid-June 2013 in
the US and in Q3 2013 in Europe and the rest of the world. Ipsen is
actively working with its third party manufacturer and the Food and
Drug Administration (FDA) to bring Increlex® back to the US
market as soon as possible.
-
On 25 April 2013 - Active Biotech and Ipsen announced that the
companies have updated the analysis plan for the 10TASQ10 trial, a
global Phase III clinical trial evaluating tasquinimod in patients
with metastatic castrate-resistant prostate cancer (mCRPC) who have
not yet received chemotherapy. The companies now plan to conduct the
primary PFS analysis for the 10TASQ10 trial in 2014, at the same time
as the first interim overall survival (OS) analysis. The time point
for the OS interim analysis will be driven by the number of OS events.
The specified number of radiographic progression-free survival (PFS)
events for the primary end-point will have been exceeded at the time
of interim OS analysis.
-
On 14 June 2013 - Ipsen announced that, as part of the accelerated
execution of its strategy in the USA, the Group adopted a new
organizational model for the distribution of Dysport® in
therapeutic indications. With the growing importance of market access
and payer driven decisions in healthcare, Ipsen is shifting its
business model toward account management in the USA. As such, the
Dysport® sales force has been optimized and refocused on
key accounts, which will allow the Group to better serve physicians
and patients.
-
On 11 July 2013 - Ipsen announced results from the primary endpoint of
the CLARINET® study, assessing the effect of Somatuline®
Autogel® 120 mg on tumor progression-free survival in
patients with gastroentero and pancreatic neuroendocrine tumors
(GEP-NETs). Treatment with Somatuline® Autogel®
120 mg was found to be statistically significantly superior to placebo
in extending time to either disease progression or death. The safety
profile observed in the study is consistent with the known safety
profile of Somatuline®. Comprehensive results from this
study were disclosed at the 2013 European Cancer Congress (Sept. 27 -
Oct. 1, 2013). CLARINET® provides medically important
results as it is the first large scale placebo-controlled randomized
study to demonstrate the antitumoral activity of a somatostatin analog
in non-functioning GEP-NETs.
-
On 15 July 2013 - Ipsen announced the closing of the acquisition of
Syntaxin, a UK-based private life sciences company specialized in
botulinum toxin engineering. Under the terms of the agreement, Ipsen
will pay €27.9 million upfront, as well as further contingent payments
that could reach €130 million or more depending on the achievement of
development and commercial milestones. Furthermore, Syntaxin's
shareholders will receive the greater part of additional downstream
payments related to the company's most advanced asset, currently in
Phase II clinical trials. The transaction fits into Ipsen's strategy
to reinforce its core technological platforms, peptides and toxins.
Syntaxin has a wealth of experience in botulinum toxin biology,
supported by an extensive patent portfolio - with 75 granted patents
and over 130 patents pending. Syntaxin and Ipsen started collaborating
in 2010. In 2011, they signed a global strategic partnership to
explore the discovery and development of new compounds in the field of
recombinant botulinum toxins. Syntaxin's team has used its extensive
expertise in the discovery of new therapeutic candidates while Ipsen
applied its skills to pharmacological, preclinical and clinical
assessment of the compounds. Prior to the transaction, Ipsen owned
c.10% of Syntaxin's capital on a fully diluted basis.
-
On 15 July 2013 - Ipsen announced that it had initiated a research and
development collaboration on novel engineered botulinum toxins with
Harvard Medical School (Harvard). Under the terms of the agreement,
Ipsen will fund Harvard research for at least three years with the aim
to discover, evaluate and develop novel engineered recombinant
botulinum toxins for the treatment of serious neurologic diseases. The
collaboration will combine Harvard's discovery platform and botulinum
toxins engineering expertise with Ipsen's know-how in drug discovery
and pharmaceutical R&D. Ipsen will have exclusive worldwide rights on
any candidate recombinant toxin stemming from the collaboration. Ipsen
will be responsible for the development and marketing of the new
toxins and will make associated upfront, milestones and royalty
payments to Harvard.
-
On 29 August 2013 - Ipsen announced the departure of Eric Drapé,
Executive Vice-President, Technical Operations. Christel Bories,
Deputy CEO, takes over his responsibilities on an interim basis.
-
On 29 August 2013 - Ipsen and Allergan have signed an agreement to
settle their dispute on patents for the therapeutic use of botulinum
toxin in urology indications. This agreement has had no impact on the
Group's treasury.
-
On 17 September 2013 - Ipsen announced positive top line results from
the primary endpoint of the ELECT® study, assessing the
effect of Somatuline® Autogel® / Somatuline®
Depot® (lanreotide) Injection 120 mg on the control of
symptoms in patients with neuroendocrine tumors (NETs) associated with
carcinoid syndrome. Treatment with Somatuline® was found to
be statistically significantly superior to placebo in decreasing the
number of days patients needed to use rescue medication (subcutaneous
somatostatin analogues i.e., octreotide) to control symptoms
associated with carcinoid syndrome.
-
On 26 September 2013 - Ipsen announced plans to relocate its U.S. R&D
operations in 2014 from Milford to Cambridge, MA - a leading hub for
biotechnology research. This site will be key for innovation in
targeted therapies across Ipsen's specialty areas as well as a center
of excellence for peptides.
-
On 28 September 2013 - Ipsen announced that results from CLARINET®
Phase III clinical trial presented at the 2013 European Cancer
Congress showed the antiproliferative effect of Somatuline®
(lanreotide) 120 mg injection in the treatment of non-functioning
gastroentero and pancreatic neuroendocrine tumors (GEP-NETs). CLARINET®
met its primary endpoint by demonstrating that treatment with
Somatuline® Autogel® / Somatuline®
Depot® (lanreotide) Injection 120 mg was associated with a
statistically significant reduction of the risk of disease progression
or death by 53% vs. placebo (hazard ratio 0.47, 95% CI: 0.30-0.73;
p=0.0002). This result is based on the observation that 62% of GEP-NET
patients treated with Somatuline® had not progressed or
died versus 22% with placebo over the follow-up period (Kaplan-Meier
estimates). The median progression free survival was not reached
(beyond 2 years) in the Somatuline® group versus 18 months
in the placebo group.
-
On 2 October 2013 - Ipsen announced its new organization project as
well as the new composition of the Executive Committee to accelerate
the implementation of the Group's strategy. The objective of the new
organization is to continue to develop Specialty Care with the
creation of two divisions represented at the Executive Committee
level: Specialty Care Franchises and Specialty Care Commercial
Operations. The project will also intensify the optimization of
Primary Care activities with the creation of a dedicated Business Unit.
-
On 7 October 2013 - PeptiDream Inc., a Tokyo-based pharmaceutical
company, and Ipsen announced that they had expanded the scope of their
April 2013 research collaboration and license option agreement to
discover, evaluate, potentially develop and launch therapeutic
peptides to treat serious medical conditions in areas of therapeutic
focus for Ipsen.
-
On 9 October 2013 - Active Biotech and Ipsen announced that Active
Biotech, under the terms of the co-development and commercialization
agreement on the novel candidate drug tasquinimod, had received a
milestone payment of €12 million from Ipsen.
-
On 6 November 2013 - Ipsen announced it has granted Natixis a mandate
to purchase 800,000 shares, or 0.95% of the capital. This mandate
begins on 6 November 2013 and will end on 6 May 2014. The purchased
shares will be cancelled. This program is part of the authorization
granted by the Combined Shareholder's meeting held on 31 May 2013. The
renewal of the authorization is subject to approval by the 2014
Shareholder's meeting of Ipsen S.A.
-
On 12 December 2013 - Ipsen announced the appointment of Dominique
Brard as Executive Vice President in charge of Human Resources of the
Ipsen group, in place of Etienne de Blois. Dominique will be a member
of Ipsen's Executive Committee. She took up her new position on
January 6th, 2014, reporting directly to Christel Bories,
Deputy CEO of Ipsen.
-
On 17 December 2013 - Ipsen announced positive initial results from
the double-blind phase III study of Dysport®
(abobotulinumtoxinA) in Adult Upper Limb spasticity. Regarding the
primary endpoints, treatment with Dysport® showed
statistically significant response versus placebo in the improvement
of muscle tone, as measured by the Modified Ashworth Scale (MAS). In
addition, a statistically significant clinical benefit for the
patients treated with Dysport® was demonstrated versus
placebo, as measured by the Physician Global Assessment (PGA). The
safety profile observed in the study was consistent with the known
safety profile of Dysport® in this indication.
Comprehensive results from this double-blind study will be disclosed
in the next few months at major international congresses.
-
On 18 December 2013 - Ipsen announced that Lonza had successfully
re-manufactured the active ingredient of Increlex®
(mecasermin [rDNA origin] Injection) and that the Group was preparing
for the resupply of Increlex® in Europe. A resupply plan
was communicated to the European Medicines Agency. Consultations with
the EU Member States' national competent authorities have allowed
immediate resupply.
-
On 18 December 2013 - Ipsen and Mayoly Spindler announced the signing
of a cross-promotion agreement for their primary care activities in
France. Through the creation of a co-managed commercial platform, the
two companies will leverage their complementary competencies and
product portfolios. Mayoly Spindler will benefit from Ipsen's
experience in the promotion of medicines to general practitioners in
France, in particular in the fields of gout and gastroenterology. In
parallel, Ipsen will benefit from Mayoly Spindler's experience in
pharmacies. This agreement leverages the complementarity of each
company's product portfolio. In the field of gastroenterology,
Meteospasmyl®, indicated to treat abdominal spasms, is
complementary to Ipsen's product range which includes Smecta®
and Forlax®. In the field of rheumatology, Colchicine®
will complement Ipsen's Adenuric®. Under the terms of the
agreement, each company will continue to book the sales of its own
products.
After 31 December 2013, major developments included:
-
On 10 January 2014 - Ipsen announced the appointment of Jonathan
Barnsley as Executive Vice President in charge of Technical
Operations. He will be a member of the Executive Committee of the
Ipsen group. He will take up his new position on April 1st,
2014, reporting directly to Christel Bories, Deputy CEO of the Ipsen
group.
-
On 14 January 2014 - Ipsen and GW Pharmaceuticals plc announced that
they have entered into an exclusive agreement for Ipsen to promote and
distribute Sativex®, a sublingual cannabis extract spray
intended for the treatment of spasticity due to multiple sclerosis in
Latin America (excluding Mexico and the Islands of the Caribbean). GW
will be responsible for commercial product supply to Ipsen. GW
Pharmaceuticals and Ipsen aim to start regulatory filings in selected
countries in Latin America during 2014 for the multiple sclerosis
spasticity indication.
-
On 14 January 2014 - Ipsen announced its decision to set up its own
oncology team to commercialize Somatuline® Depot®
(lanreotide) 120 mg Injection (« Somatuline® ») in
neuroendocrine tumors in the US. Over the past few months, the Group
had been considering both a "go-it-alone" and a partnership strategy
following the communication of the data from the investigational
CLARINET® phase III clinical study evaluating the
antiproliferative effect of Somatuline® in the treatment of
non-functioning gastrointestinal & pancreatic NETs (GEP NETs). Ipsen
expects that these encouraging results will support a key long-term
opportunity for the Group to access an US addressable market in excess
of $500 million1. Ipsen considers success in the US
as a strategic priority. The "go-it-alone" option maximizes long term
value creation and helps the US affiliate in reaching critical mass.
Ipsen anticipates filing a Supplemental New Drug Application seeking
an indication for Somatuline® in NETs in the first half of
2014. Maximum incremental annual cost associated with the launch of
Somatuline® in the NET indication in the US is expected to
range from €30 million to €40 million. As a result, US breakeven2,
initially expected in 2014, is postponed to 2017. Ipsen will continue
to implement cost containment initiatives to minimize impact on
overall Group profitability.
-
On 17 January 2014 - Ipsen announced at ASCO GI that ELECT®
clinical trial of Somatuline® in the control of symptoms in
GEP-NET patients with carcinoid syndrome met its primary endpoint.
Results of the ELECT® phase III study (poster 268) showed
that treatment with Somatuline® 120 mg versus placebo
resulted in a statistically significant reduction in the number of
days in which immediate release octreotide was used as rescue
medication, representing a mean difference of -14.8% (95%CI: -26.8,
-2.8; p = 0.017). Somatuline® significantly improved the
rates of complete/partial treatment success versus placebo (odds ratio
= 2.4; 95%CI: 1.1, 5.3; p = 0.036).
-
On 22 January 2014 - Ipsen announced the implementation of new
governance in the United States, following its recently announced
decision to launch Somatuline® for oncology indications.
Marc de Garidel will personally oversee this projected launch. Cynthia
Schwalm will join Ipsen's US Operations to head up the
Endocrinology/Oncology Business Unit as of 3 February, 2014. As of
mid-August 2014, she will take over as General Manager of the US
commercial affiliate.
-
On 5 February 2014 - Ipsen announced the results of the international
Phase III clinical trial of Dysport® Next Generation (DNG)
in cervical dystonia and the results of the European Phase II clinical
trial of DNG in glabellar lines. In the light of these results, Ipsen
announces its intention to file the first ready-to-use liquid toxin A
in Europe and in the Rest of the World3 (ROW). DNG was
clinically and statistically superior to placebo in the cervical
dystonia Phase III study at the dose of 500 units at week 4 after
single dose (adjusted mean reduction of 12.5 with DNG versus 3.9 with
placebo as assessed by the Toronto Western Spasmodic Torticollis
Rating Scale, or TWSTRS, total score). When compared to Dysport®,
DNG did not demonstrate the statistical non-inferiority in efficacy at
week 4 (adjusted mean reduction of 12.5 with DNG versus 14.0 with
Dysport® in TWSTRS total score). This efficacy difference
is unlikely to be of clinical relevance. After repeated dose, DNG
showed comparable efficacy to that of Dysport® as observed
in former Phase III studies4. DNG was clinically and
statistically superior to placebo and comparable to Dysport®
in the glabellar lines Phase II study at the dose of 50 units after
single dose. Across the studies, DNG showed safety profiles consistent
with the known safety profile of Dysport®. Regarding DNG
stability, analysis is still ongoing. The stability data trends are
positive, providing confidence of achieving a commercially viable
product. Ipsen is continuing stability testing to establish maximum
shelf life across full product range. On the basis of these results
and feedback from the Principal Investigator of the Phase III study,
Ipsen intends to initiate a dialog with key agencies on the regulatory
approach to file the first ready-to-use liquid toxin A in Europe and
ROW3.
-
On 7 February 2014 - Ipsen announced that the phase III clinical trial
evaluating Decapeptyl® (triptorelin pamoate) 11.25 mg
administered subcutaneously in patients with locally advanced or
metastatic prostate cancer has met its primary endpoints. The full
study results will be presented this year during a medical congress.
Based on these results, Ipsen intends to apply for the addition of the
subcutaneous route, alongside the intramuscular route, to the label of
triptorelin pamoate 11.25 mg.
1 Ipsen 2013 estimates of US NET market
2 Commercial contribution excluding Increlex®
(mecasermin [rDNA origin]) Injection sales and revenues from U.S.
collaboration with Valeant Pharmaceuticals Intl Inc. in aesthetic
medicine
3 Latin America, Middle East and Asia (ex Japan and China)
4 Truong D. et al. Mov. Disord., 2005; 20 (7) 783-791; Truong
et al., Parkinsonism Relat Disord. 2010 Jun;16(5):316-23
Government measures
In the current context of financial and economic crisis, the governments
of many countries in which the Group operates continue to introduce new
measures to reduce public health expenses, some of which have affected
the Group sales and profitability in 2013. In addition, certain measures
introduced in 2012 have continued to affect the Group's accounts
year-on-year.
Measures impacting 2013
In the Major Western European countries:
-
In France, Tanakan® was delisted on 1st March
2012. Moreover, sales of Nisis®/Nisisco® and
Forlax® were negatively impacted by a step-up in the
regulation known as "Tiers-payant" in July 2012, whereby the patient
must pay upfront for a branded drug at the pharmacy - when genericized
- and is reimbursed only later on. In addition, health authorities
imposed price cuts of 5.5% on NutropinAq® in June 2013 and
12.5% on Nisis®/Nisico® in October 2013;
-
In Spain, Tanakan® was delisted on 1st September
2012. The new draft of the Royal Decree that establishes the prices
for products that have been marketed for more than 10 years was issued
in March 2013 and affects all the LhRH (Luteinizing
hormone-Releasing Hormone) analogues. The application of the final
version was expected in Q3 2013, but was finally postponed to Q1 2014;
-
In Italy, the price alignment of LhRH regional tenders is not yet
applicable due to the political context.
In the Other European countries:
-
In Belgium, a modulated price decrease of 1.95% on reimbursed products
has been applicable since 1st April 2013 on top of the
Inami tax;
-
In the Netherlands, the NZA (Dutch health authority) transferred the
budget for Growth Hormones from retail to hospital and introduced a
new reimbursement system on 1st January 2013. The
publication of the list containing the next wave of drugs to move to
hospital budget was officially delayed. In both April 2013 and October
2013, Ipsen products were affected by price revisions due to the
application of international reference pricing. This led to price
increases on Decapeptyl®, Dysport® and Somatuline®
and to a price decrease on NutropinAq®;
-
In Finland, a general price cut of 5% was applied on all drugs as of 1st
February 2013;
-
In Portugal, new countries were included in the basket for the
international reference pricing system, such as Slovakia, Spain and
France. For retail products, the rule is to take the average of the
basket. For hospital products, the rule is to take the lowest price of
the basket. There is no significant impact on Ipsen's products. New
measures published in 2013 called for a 6.0% price cut on all drugs
and for a contribution of the pharmaceutical industry to the decrease
of healthcare spending through the setup, by every pharmaceutical
company, of a provision fund equal to 2.0% of sales;
-
In Greece, the new reimbursement list based on hybrid ATC4
classification and patient co-payment amounts was implemented,
replacing the former reimbursement rule. A new price bulletin was
published on 1st April 2013 impacting all LhRH analogues.
Following negotiations with the Greek Ministry of Health, the price of
Increlex® was increased by 1.25% in September 2013 to
account for its orphan drug status;
-
In Latvia, a national tender for LhRH analogues was put in place by
local authorities in order to avoid parallel trades. A new reference
basket was set up in July 2013. Initially, the basket was composed of
all members of the European Union but now comprises Lithuania,
Estonia, Czech Republic, Slovakia, Romania, Hungary, and Denmark. The
reference pricing rule remains unchanged and calls for taking the 3rd
lowest price of the basket;
-
In Czech Republic, the VAT on drugs was increased from 14% to 15% in
January 2013. New prices were published on 1st January
2013. They stem from the international reference pricing system
(average of the 3 lowest prices in 18 countries of the EU). Moreover,
since January 2013, Growth Hormones are no longer considered a
hospital product and are now subject to price revisions;
-
In Slovakia, new prices were published on 1st June 2013.
They were the result of the international reference pricing system
based on the average of the 3 lowest prices prevailing in the 28
countries of the EU;
-
In Poland, a new reimbursement limit was set after the launch of a
competing product to Decapeptyl®. It led to the
introduction of patient co-payments since 1st January 2013
and, thereafter, to a general price decrease by the industry as a way
of compensating;
-
In Romania, whereas prices are generally revised annually in March,
the Ministry of Health has decided to freeze medicine prices until the
end of 2013. In the meantime, the price setting methodology for new
products will remain unchanged.
In the Rest of the World:
-
China is still working on its international reference pricing system,
which would include ten countries such as the USA, France, Germany,
South Korea and Japan. However, there was no sign of further
implementation or control at this time. Earlier this year, Tanakan®
was included on the Essential Drug List (EDL), a decision usually
accompanied by a price decrease;
-
In Algeria, the "Ministère du Travail, de l'Emploi et de la Sécurité
Sociale" (Ministry of Labour, Employment and Social Security) has
finalized its List of Reference Tariffs (LTR). Class referencing on
GnRH (Gonadotropin-Releasing Hormone) analogs was confirmed in
October 2013 and is expected to be implemented in the first months of
2014. Once effective, the price of Decapeptyl® will be
aligned with that of the cheapest molecule;
-
In Colombia, the "National Committee of Drug Prices" (Comisión
Nacional de Precios de Medicamentos) announced its intention to
regulate the price of 195 medicines, including that of Somatuline®.
New prices have been effective since their publication in the official
gazette on 23rd August 2013.
Furthermore, and in the context of the 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 which
will affect the Group sales and profitability beyond 2013.
Measures impacting 2014 and beyond
In the Major Western European countries:
-
In France, Smecta® experienced a first price cut of 7.5% on
1st January 2014 and will experience a second 7.5% cut on 1st
July 2014. Fortrans® price was cut 6.5% on 1st
January 2014;
-
In Germany, the government decided to partially revoke the AMNOG (The
Pharmaceuticals Market Reorganisation Act) legislation introduced in
2010. Among other things, the pricing act entailed a mandatory 16%
sales rebate for all prescription drugs, which has been reduced to 7%
effective 1st January 2014;
-
In Italy, the cap for pharmaceutical hospital expense was increased
from 2.4% to 3.5% of hospital expenditure. In addition, pharmaceutical
companies will have to pay 50.0% of any extra expenditure beyond this
cap level. Also, Hexvix® will now be reimbursed at national
level instead of being included in hospital budgets, which led to an
official 6.5% price decrease;
-
In the UK, a new PPRS (Pharmaceutical Price Regulation Scheme)
was voted. It will have no impact on NHS prices, but will require a
contribution estimated at less than 4% of net NHS sales in 2014, with
a further increase anticipated in the following years. Moreover,
tendering negotiations in 2014 will no longer take place by account
(hospital) but by region.
In the Other European countries:
-
In Portugal, the outcome of negotiations between the pharmaceutical
industry and the Ministry of Health on the reimbursement threshold
borne by the industry is expected soon. The final 2012 reimbursement
amount is not yet confirmed, nor is the 2013 threshold. The final
agreement will very much depend on the level of drug expenditure
reached in 2013 as a percentage of GDP. Moreover, a new 3.0% tax, to
become effective in 2014, has also been introduced on all hospital
business. Finally Slovenia replaced Slovakia in the basket for the
international reference pricing system;
-
In Greece, claw-back will potentially be adjusted by year-end and the
target set by the Ministry of Health for 2013 currently stands at €2.4
billion. The government is aiming at €2.0 billion for 2014;
-
In Belgium, the international reference pricing system was updated
with new rules and a reference basket of 6 countries (France, Germany,
the Netherlands, Austria, Ireland and Finland). The system has not yet
been implemented;
-
In the Netherlands, the new price list stemming from international
price referencing has been published in October 2013;
-
In Sweden, TLV (The Dental and Pharmaceutical Benefits Agency)
announced that all products made out of a substance that has been
registered for more than 15 years will have to lower their prices. A
7.5% price reduction will apply to all formulations of NutropinAq®
and Decapeptyl® as of 1st January 2014;
-
In Croatia, Czech Republic replaced France in the basket of countries
included in the international reference pricing system;
-
In Serbia, as of 1st July 2013, the Ministry of Health
decided to include Romania in the basket of countries used for the
calculation of international reference pricing. The rule is to take
the average of the prices prevailing in Croatia, Slovenia, Italy and
Romania;
-
In Poland, a new legal act has been published leading to price
reductions on Decapeptyl® and Somatuline® as of 1st
January 2014;
-
In Slovakia, as of 1st March 2014, a price decrease based
on the average of the 3 lowest prices in the EU 28 will apply to
several Ipsen products;
-
In Slovenia, therapeutic reference pricing was introduced in June 2013
but does not yet apply.
In the Rest of the World:
-
In Latin America, twelve 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 in the region. At this stage, there has been
no new announcement regarding this project;
-
In Colombia, the application of international price referencing will
affect the price of Dysport® 500U, after having impacted
that of Somatuline® in August 2013;
-
In Brazil, class referencing has been introduced for the public
market. Hence, due to competition, the price of Dysport®
500U could be reduced every year over the next 4 years;
-
In Tunisia, the Somatuline® Autogel® range was
officially registered in Q4 2013, which will drive the "Pharmacie
Centrale Tunisienne" import price of Somatuline® down in
2014;
-
In Algeria, Ipsen had to renew the Marketing Authorization for all its
Primary Care products before the end of 2013. This process could lead
to price revisions in the first semester of 2014;
-
In Morocco, due to class referencing, the price of Decapeptyl®
3M should be cut by 20% following the potential introduction of a
Goserelin generic in the early months of 2014;
-
In China, the price of Tanakan® could be cut in May 2014,
following its inclusion on the Essential Drug List (EDL) in the ginkgo
biloba extract category. Ipsen is contemplating different scenarios
going forward;
-
In Korea, the volume-price control implemented since 2011 will end in
2014, with an ultimate 7% price cut on Decapeptyl® in
January 2014.
Comparison of consolidated income statement for 2013 and 2012
(in million euros)
|
|
31 December 2013
|
|
31 December 2012
|
|
Change
|
|
|
|
restated(2)
|
|
|
|
|
|
% sales
|
|
|
|
% sales
|
|
|
Sales
|
|
1,224.8
|
|
100.0%
|
|
1,219.5
|
|
100.0%
|
|
0.4%
|
|
Other revenues
|
|
57.0
|
|
4.7%
|
|
57.9
|
|
4.7%
|
|
-1.5%
|
|
Revenues
|
|
1,281.8
|
|
104.7%
|
|
1,277.4
|
|
104.7%
|
|
0.3%
|
|
Cost of goods sold
|
|
(253.4)
|
|
-20.7%
|
|
(254.3)
|
|
-20.9%
|
|
-0.4%
|
|
Research and development expenses
|
|
(259.1)
|
|
-21.2%
|
|
(248.2)
|
|
-20.3%
|
|
4.4%
|
|
Selling expenses
|
|
(451.3)
|
|
-36.8%
|
|
(473.0)
|
|
-38.8%
|
|
-4.6%
|
|
General and administrative expenses
|
|
(103.8)
|
|
-8.5%
|
|
(99.1)
|
|
-8.1%
|
|
4.8%
|
|
Other operating income
|
|
5.7
|
|
0.5%
|
|
5.6
|
|
0.5%
|
|
2.2%
|
|
Other operating expenses
|
|
(12.0)
|
|
-1.0%
|
|
(25.8)
|
|
-2.1%
|
|
-53.6%
|
|
Depreciation of intangible assets (3)
|
|
(4.4)
|
|
-0.4%
|
|
(5.8)
|
|
-0.5%
|
|
-23.6%
|
|
Restructuring costs
|
|
(0.2)
|
|
0.0%
|
|
(62.1)
|
|
-5.1%
|
|
-99.6%
|
|
Impairment gain/(losses)
|
|
(12.6)
|
|
-1.0%
|
|
2.4
|
|
0.2%
|
|
-629.4%
|
|
Operating income
|
|
190.7
|
|
15.6%
|
|
117.1
|
|
9.6%
|
|
62.9%
|
|
Recurring adjusted operating income (1)
|
|
208.6
|
|
17.0%
|
|
198.3
|
|
16.3%
|
|
5.2%
|
|
Investment income
|
|
8.0
|
|
0.7%
|
|
1.0
|
|
0.1%
|
|
706.4%
|
|
Financing costs
|
|
(2.2)
|
|
-0.2%
|
|
(2.3)
|
|
-0.2%
|
|
-3.0%
|
|
Net financing costs
|
|
5.8
|
|
0.5%
|
|
(1.3)
|
|
-0.1%
|
|
-
|
|
Other financial income and expense
|
|
(14.8)
|
|
-1.2%
|
|
6.8
|
|
0.6%
|
|
-
|
|
Income taxes
|
|
(39.6)
|
|
-3.2%
|
|
(25.2)
|
|
-2.1%
|
|
-
|
|
Share of profit (loss) from associated companies
|
|
|
|
-
|
|
|
|
-
|
|
-
|
|
Net profit (loss) from continuing operations
|
|
142.2
|
|
11.6%
|
|
97.4
|
|
8.0%
|
|
46.0%
|
|
Net profit (loss) from discontinued operations
|
|
10.9
|
|
0.9%
|
|
(124.8)
|
|
-10.2%
|
|
-108.7%
|
|
Consolidated net profit
|
|
153.1
|
|
12.5%
|
|
(27.5)
|
|
-2.3%
|
|
-
|
|
- Attributable to shareholders of Ipsen S.A.
|
|
152.5
|
|
|
|
(27.9)
|
|
|
|
|
|
- Minority interests
|
|
0.6
|
|
|
|
0.5
|
|
|
|
|
|
(1) See appendix 4
(2) For purposes of comparison between the two financial
years, the 2012 income statement has been restated in accordance with
IAS 19 revised (see appendix 5)
(3) Excluding software
Consolidated Group sales reached €1,224.8 million in 2013, up 0.4%
year-on-year and up 2.2% excluding foreign exchange impact1.
Other revenues amounted to €57.0 million in 2013, down 1.5% compared to
€57.9 million in 2012.
Other revenues break down as follows:
(in million euros)
|
|
31 December 2013
|
|
31 December 2012
|
|
Change
|
|
|
|
restated(2)
|
|
in value
|
|
in %
|
|
Breakdown by type of revenue
|
|
|
|
|
|
|
|
|
|
- Royalties received
|
|
15.3
|
|
11.9
|
|
3.4
|
|
28.8%
|
|
- Milestone payments - Licensing agreements (1)
|
|
24.0
|
|
25.1
|
|
-1.1
|
|
-4.4%
|
|
- Other (co-promotion revenues, re-billings)
|
|
17.7
|
|
20.9
|
|
-3.2
|
|
-15.3%
|
|
Total
|
|
57.0
|
|
57.9
|
|
-0.9
|
|
-1.5%
|
|
(1) Milestone payments relating to licensing agreements are
recognized primarily as milestone payments received on a pro rata basis
over the life of partnership agreements
(2) For purposes of comparison between the two financial
years, the 2012 income statement has been restated in accordance with
IAS 19 revised (see appendix 5)
-
Royalties received amounted to €15.3 million in 2013, up €3.4
million year-on-year, driven by the increase in royalties paid by
Group partners.
-
Milestone payments relating to licensing agreements amounted to
€24.0 million in 2013, mainly generated by the partnerships with
Medicis (acquired by Valeant in 2012), Menarini, and Galderma.
-
Other revenues, which primarily included revenues from the
Group's co-promotion and co-marketing agreements in France, amounted
to €17.7 million in 2013, compared with €20.9 million the previous
year. In 2013, except for residual compensation paid to Ipsen by
Novartis, this line item no longer included revenues from Exforge®,
following the April 2012 termination of the co-promotion agreement
with Novartis in France.
-
Cost of goods sold
In 2013, the cost of goods sold amounted to €253.4 million, representing
20.7% of sales, compared with €254.3 million, or 20.9% of sales, for the
same period in 2012.
The improvement in cost of goods sold in 2013 stemmed notably from a
favourable product mix and increased productivity efforts, partially
offset by higher custom duties, as a result of the Group's increased
business activity in certain countries and the decline in primary care
volumes.
-
Research and development expenses
At 31 December 2013, research and development expenses represented
€259.1 million or 21.2% of sales, compared with 20.3% of sales the
previous year.
1 Variations excluding foreign exchange impact were
calculated by restating the 31 December 2012 figures with the exchange
rates at 31 December 2013
The table below provides a comparison of research and development
expenses for 2013 and 2012:
(in million euros)
|
|
31 December 2013
|
|
31 December 2012
|
|
Change
|
|
|
|
restated(4)
|
|
in value
|
|
in %
|
|
Breakdown by expense type
|
|
|
|
|
|
|
|
|
|
- Drug-related research and development (1)
|
|
(210.9)
|
|
(198.9)
|
|
(12.0)
|
|
6.0%
|
|
- Industrial and pharmaceutical development (2)
|
|
(40.9)
|
|
(40.9)
|
|
(0.0)
|
|
0.1%
|
|
- Strategic development (3)
|
|
(7.2)
|
|
(8.3)
|
|
1.1
|
|
-13.4%
|
|
Total
|
|
(259.1)
|
|
(248.2)
|
|
(10.9)
|
|
4.4%
|
|
(1) Drug-related research & development aims at identifying
new agents, determining their biological characteristics and developing
small-scale manufacturing processes. Patent-related expenses are
included in this type of expense.
(2) Industrial development includes the chemical,
biotechnical and development-process research costs to industrialise the
small-scale production of agents developed by the research laboratories.
The role of pharmaceutical development is to lead new product
development projects, such as bibliographic research, formulation
feasibility studies, method adaptation, method development and
validation, and transpositions.
(3) Strategic development includes costs incurred for
research into new product licenses and establishing partnership
agreements.
(4) For purposes of comparison between the two financial
years, the 2012 income statement has been restated in accordance with
IAS 19 revised (see appendix 5)
Drug-related research and development costs increased 6.0% versus
2012. The main research and development projects for 2013 included
Dysport® (spasticity of the lower and upper limbs),
tasquinimod and Somatuline®.
Industrial and pharmaceutical development costs were stable
year-on-year. These expenses notably included costs related to the
validation of the tasquinimod manufacturing process, to the on-going
rollout of a development platform for toxins, and to the work on a
ready-to-use, liquid formulation for Dysport® (Dysport®
Next Generation).
-
Selling, general and administrative expenses
Selling, general and administrative expenses amounted to €555.1 million
in 2013, representing 45.3% of sales, down 1.6% versus 2012.
The table below provides a comparison of selling, general and
administrative expenses between 2013 and 2012:
(in million euros)
|
|
31 December 2013
|
|
31 December 2012
|
|
Change
|
|
|
|
restated(1)
|
|
in value
|
|
in %
|
|
Breakdown by expense type
|
|
|
|
|
|
|
|
|
|
Royalties paid
|
|
(51.9)
|
|
(51.7)
|
|
(0.2)
|
|
0.4%
|
|
Other sales and marketing expenses
|
|
(399.3)
|
|
(421.3)
|
|
21.9
|
|
-5.2%
|
|
Selling expenses
|
|
(451.3)
|
|
(473.0)
|
|
21.7
|
|
-4.6%
|
|
General and administrative expenses
|
|
(103.8)
|
|
(99.1)
|
|
(4.7)
|
|
4.8%
|
|
Total
|
|
(555.1)
|
|
(572.1)
|
|
17.0
|
|
-3.0%
|
|
(1) For purposes of comparison between the two financial
years, the 2012 income statement has been restated in accordance with
IAS 19 revised (see appendix 5)
Selling expenses amounted to €451.3 million in 2013, representing
36.8% of sales, compared to €473.0 million in 2012, or 38.8% of sales.
-
Royalties paid to third parties on sales of products marketed by the
Group totalled €51.9 million in 2013, up 0.4% year-on-year. This
increase was driven by improved in-market sales of in-licensed
products;
-
Other sales and marketing expenses amounted to €399.3 million, or
32.6% of sales, down 5.2% from the €421.3 million, or 34.5% of sales,
recorded the previous year. The decline stemmed from the restructuring
of both the French primary care sales force and the US sales force.
General and selling expenses grew 4.8% in 2013. The
increase resulted notably from actions taken to accelerate the execution
of the Group's strategy, as well as from a step-up in tax measures in
France.
-
Other operating income and expenses
Other operating income, which primarily included revenue from the
sublease of Ipsen's headquarters building, amounted to €5.7 million in
2013, compared with €5.6 million the prior year.
Other operating expenses amounted to €12.0 million, down from €25.8
million in 2012. Besides headquarters rental costs, other operating
expenses primarily included non-recurring costs related to the
acquisition of Syntaxin Ltd., the reorganisation of the US subsidiary,
and the settlement of a trade dispute with a partner and of an
administrative proceeding brought against the Group.
-
Amortisation of intangible assets (excluding software)
At 31 December 2013, amortisation charges of intangible assets reached
€4.4 million, compared to €5.8 million the previous year. The decrease
is mainly due to the discontinuation of the IGF-1 license amortisation,
following the new impairment loss recognised at 30 June 2013 (see
impairment losses paragraph) and the complete amortisation of Exforge®
(termination of the co-promotion agreement with Novartis in France
effective 30 April 2012).
The Group recorded €0.2 million in non-recurring restructuring costs at
31 December 2013, mainly arising from the reversal of an accrual related
to the primary care restructuring plan in France, offset by
restructuring costs in the US and by costs incurred by the Group to
accelerate the implementation of transformation initiated in 2011, that
aims at adapting the Group's operating structures to future challenges.
In 2013, these costs were mainly related to measures taken to adjust
resources in certain geographies following the implementation of the new
strategy, the transformation and reorganization of Research and
Development activities and the adjustment of support functions.
In June 2013, as part of its effort to accelerate the execution of its
strategy in the United States, the Group adopted a new key account
management organisational model for the distribution of Dysport®
in therapeutic indications in the US market. The decision was based on
the growing importance of payer driven decision-making and new market
access conditions in healthcare. Accordingly, Dysport® sales
forces were streamlined and refocused to better serve physicians and
patients. At 31 December 2013, the Group recognised non-recurring costs
of €4.1 million, which primarily included compensation-related expenses
for the early termination of employment contracts.
At 31 December 2013, the Group recorded a non-recurring impairment loss
of €12.6 million.
In the first half of 2013, Ipsen announced that Lonza, the supplier of
Increlex®'s active ingredient (mecasermin [rDNA origin]), was
facing manufacturing issues with Increlex® at its Hopkinton
(MA, USA) production site. Increlex® supply interruption
began in the US in mid-June 2013, and affected Europe and the rest of
the world in the third quarter of the year.
Furthermore, Lonza on 25 July 2013 announced that it would gradually
wind down its Hopkinton site. Lonza however said that the closure would
not affect its obligations to customers.
In view of the supply interruption and the uncertainty about the date of
re-supply in the US, the Group recognised a non-recurring €11.6 million
impairment loss on the Increlex® IGF-1 active ingredient at
30 June 2013. On 18 December 2013, Ipsen announced that Lonza had
successfully re-manufactured the active ingredient of Increlex®.
The European Medicines Agency (EMA) was informed that Ipsen was
preparing for the resupply of Increlex® in the European Union
(EU). Consultations with the EU Member States' national competent
authorities allowed for a re-supply early 2014.
However, resupply in the US is still under review. Ipsen is actively
working with its third party manufacturer and the Food and Drug
Administration (FDA) to bring Increlex® back to the US market
as soon as possible. Given the uncertainty around the resupply of the US
market, there was no accrual reversal related to Increlex®'s
active ingredient in the consolidated financial statements for the year
ended 31 December 2013.
With this impairment loss, the carrying value of the IGF-1 asset became
zero.
Ipsen also recognised a €1.0 million impairment loss following a
decision by the Group not to exercise its right to develop a neurology
programme.
Based on the above items, the operating income reported at 31 December
2013 amounted to €190.7 million, or 15.6% of sales. In 2012, operating
income represented 9.6% of Group sales and was notably impacted by
restructuring costs associated with the primary care restructuring plan
in France and costs related to the transfer to the East cost of the
Group's North American commercial subsidiary that occurred between June
2011 and June 2012.
The Group's recurring adjusted2 operating
income amounted to €208.6 million at 31 December 2013, or 17.0% of
consolidated sales, up 5.2% compared to 2012.
-
Operating segments: Operating income by geographical region
On 2 October 2013, Ipsen announced its project of new organization and
new composition of the Executive Committee to accelerate strategy
implementation. The purpose of the new organization is to help optimize
Primary care activities through the setting up of a new dedicated
Business Unit and to continue to develop Specialty care.
Specialty care and Primary care will now be managed separately, because
their activities have very different strategic and operational
rationales, with specific organizations, resources and profiles adapted
to the challenges facing each organization.
The implementation of this project was subject to the examination by the
staff representative bodies competent in each country concerned,
according to the specific processes and methods laid down in the
regulations governing each country.
Because this organisation was not in effect in 2013, the related
operating segment information was left unchanged in the financial
statements ended 31 December 2013. Indeed, the internal reporting
provided throughout 2013 to the "chief operating decision-maker", i.e.
the Executive Committee, thus corresponds to the Group's managerial
organisation based on the geographical regions in which the Group
operates.
Accordingly, operating segments, as defined in IFRS 8, correspond to
long-term groupings of countries. Operating segments existing as of 31
December 2013 were as follows:
"Major Western European countries": France, Italy, Spain, the United
Kingdom and Germany;
"Other European countries": other Western European countries and Eastern
Europe;
"North America": comprising for the most part the United States and
Canada;
"Rest of the World": all countries not included in the three preceding
operating segments.
The table below provides an analysis of sales, revenues and operating
income by operating segment for 2013 and 2012:
|
|
31 December
|
|
31 December 2012
|
|
Change
|
|
|
|
2013
|
|
restated*
|
|
|
|
|
|
|
|
% of
|
|
|
|
% of
|
|
|
|
|
|
(in million euros)
|
|
|
|
sales
|
|
|
|
sales
|
|
|
|
%
|
|
Major Western European countries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
|
|
497.3
|
|
100.0%
|
|
518.5
|
|
100.0%
|
|
(21.2)
|
|
-4.1%
|
|
Revenue
|
|
525.2
|
|
105.6%
|
|
549.9
|
|
106.0%
|
|
(24.8)
|
|
-4.5%
|
|
Operating income
|
|
196.5
|
|
39.5%
|
|
140.5
|
|
27.1%
|
|
56.1
|
|
39.9%
|
|
Other European countries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
|
|
329.4
|
|
100.0%
|
|
306.0
|
|
100.0%
|
|
23.4
|
|
7.6%
|
|
Revenue
|
|
336.9
|
|
102.3%
|
|
312.2
|
|
102.0%
|
|
24.7
|
|
7.9%
|
|
Operating income
|
|
146.8
|
|
44.6%
|
|
135.9
|
|
44.4%
|
|
10.9
|
|
8.0%
|
|
North America
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
|
|
64.2
|
|
100.0%
|
|
72.8
|
|
100.0%
|
|
(8.5)
|
|
-11.7%
|
|
Revenue
|
|
81.8
|
|
127.3%
|
|
90.5
|
|
124.4%
|
|
(8.7)
|
|
-9.6%
|
|
Operating income
|
|
11.0
|
|
17.1%
|
|
(10.5)
|
|
-14.5%
|
|
21.5
|
|
-204.2%
|
|
Rest of the World
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
|
|
333.9
|
|
100.0%
|
|
322.2
|
|
100.0%
|
|
11.7
|
|
3.6%
|
|
Revenue
|
|
336.3
|
|
100.7%
|
|
323.5
|
|
100.4%
|
|
12.9
|
|
4.0%
|
|
Operating income
|
|
137.8
|
|
41.3%
|
|
123.2
|
|
38.2%
|
|
14.6
|
|
11.8%
|
|
Total allocated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
|
|
1,224.8
|
|
100.0%
|
|
1,219.5
|
|
100.0%
|
|
5.3
|
|
0.4%
|
|
Revenue
|
|
1,280.2
|
|
104.5%
|
|
1,276.1
|
|
104.6%
|
|
4.1
|
|
0.3%
|
|
Operating income
|
|
492.1
|
|
40.2%
|
|
389.0
|
|
31.9%
|
|
103.0
|
|
26.5%
|
|
Total unallocated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
1.6
|
|
-
|
|
1.3
|
|
-
|
|
0.3
|
|
20.4%
|
|
Operating income
|
|
(301.3)
|
|
-
|
|
(271.9)
|
|
-
|
|
(29.4)
|
|
10.8%
|
|
Group total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
|
|
1,224.8
|
|
100.0%
|
|
1,219.5
|
|
100.0%
|
|
5.3
|
|
0.4%
|
|
Revenue
|
|
1,281.8
|
|
104.7%
|
|
1,277.4
|
|
104.7%
|
|
4.4
|
|
0.3%
|
|
Operating income
|
|
190.7
|
|
15.6%
|
|
117.1
|
|
9.6%
|
|
73.6
|
|
62.9%
|
|
* For purposes of comparison between the two financial years, the 2012
income statement has been restated in accordance with IAS 19 revised
(see appendix 5)
Sales generated in the Major Western European countries amounted
to €497.3 million in 2013, down 4.1% year-on-year. The growth of
specialty care products was more than offset by the consequences of a
tougher competitive environment in the French primary care market. Sales
in the Major Western European countries represented 40.6% of total Group
sales in 2013, compared to 42.5% the previous year. In 2013, operating
income amounted to €196.5 million, up 39.9% year-on-year, representing
39.5% of sales, compared to 27.1% in 2012, notably resulting from the
primary care restructuring plan in France. In 2012, the Group had
recorded €57.6 million non-recurring costs related to the primary care
restructuring plan in France.
Sales generated in the Other European countries (other Western
and Eastern European countries) reached €329.4 million, up 7.6%. Sales
growth was mainly driven by the good performance of Russia where primary
care (notably Fortrans®, Tanakan® and Smecta®)
and specialty care (notably Dysport® and Decapeptyl®)
posted strong growth rates. Over the period, the supply of Dysport®
for aesthetic use to Galderma contributed to growth. The Netherlands,
Ukraine, Kazakhstan and Turkey notably posted strong performance. In
2013, sales in this region represented 26.9% of consolidated Group
sales, compared to 25.1% a year earlier. Operating income in 2013
amounted to €146.8 million, compared to €135.9 million the previous
year, and represented 44.6% of the region's sales for the year, up from
44.4% the previous year.
In North America, 2013 sales amounted to €64.2 million, down
11.7%. Restated for the Increlex® supply interruption, sales
were up 3.0% year-on-year, driven by the strong volume growth and
continued penetration of Somatuline® in the acromegaly
market, by the double-digit growth of Dysport® in
therapeutics and by the continuous supply of Dysport® for
aesthetic use to Valeant. In 2013, sales in North America represented
5.2% of consolidated Group sales, compared to 6.0% a year earlier.
Operating income totalled €11.0 million, representing a €21.5 million
improvement over 2012. The increase stemmed primarily from a steep
reduction in selling and administrative costs, following the
restructuring of the commercial subsidiary.
In the Rest of the World, where the Group markets most of its
products through distributors or commercial agents, except in a few
countries where Ipsen has a direct presence, sales amounted to €333.9
million, up 3.6%. During the year, sales were affected by an exceptional
political situation in certain Middle Eastern countries where Ipsen, in
the absence of payment guarantees, had stopped supplying its products in
the second quarter. Moreover, 2013 sales were affected by the
performance of Decapeptyl® in China, where the product
suffered from the disruption of hospital market promotion due to the
investigation of certain pharmaceutical companies by local authorities.
Sales growth was fuelled by the good performance of primary care in
China (notably Smecta® and Etiasa®) and in Algeria
(notably Smecta® and Forlax®), of Dysport®
in Brazil, of Somatuline® in Australia, and of the Sanofi
partnership in Mexico. Over the period, sales in the Rest of the World
continued to grow to reach 27.3% of total consolidated Group sales,
compared to 26.4% the previous year. Operating income for the year
totalled €137.8 million, up 11.8% over the €123.2 million posted in
2012, and represented respectively 41.3% and 38.2% of sales in 2013 and
2012.
Unallocated operating income (expenses) amounted to (€301.3)
million, compared with (€271.9) million in 2012. The expenses consisted
mainly of the Group's central research and developments costs for €281.1
million in 2013, compared with €263.7 million in 2012, and, to a lesser
extent, unallocated general and administrative expenses. Unallocated
revenue amounted to €1.6 million in 2013, compared with €1.3 million the
previous year.
-
Net financing costs and other financial income and expenses
At 31 December 2013, the Group had net financial expense of €9.0
million, compared to a net financial income of €5.4 million the previous
year.
The net financing costs represented a €5.8 million income,
compared to a €1.3 million expense in 2012. The net income mainly
resulted from a financial gain on the repayment of the
Debtor-in-Possession (DIP) financing granted by Ipsen to Inspiration
Biopharmaceuticals Inc. at the end of 2012, following the sale of its
hemophilia assets to Baxter and Cangene.
Other financial income and (expenses) amounted to (€14.8) million
at 31 December 2013. The expense primarily arose from a negative
€11.2 million foreign exchange impact and a €2.0 million depreciation
charge on convertible bonds subscribed by the Group to develop a
neurology programme. At 31 December 2012, the Group recognised other
financial income of €6.8 million, resulting from an unfavourable
exchange rate impact, additional payments received on its sale of
PregLem Holdings SA shares in 2010, and a profit from the sale of shares
in Spirogen Plc during the year.
At 31 December 2013, the effective tax rate was 21.8% of profit before
tax from continuing operations, compared with an effective rate of 20.6%
a year earlier.
The difference notably resulted from the implementation in France of a
new 3.0% tax on dividend payouts, which negatively impacted the
effective tax rate by 1.1 percentage points.
Excluding non-recurring operating, financial and fiscal items, the
Group's effective tax rate amounted to 20.6% in 2013, compared with
23.3% in 2012.
-
Net profit (loss) from continuing operations
As a result of the above items, at 31 December 2013, profit from
continuing operations amounted to €142.2 million, up 46.0% from the
€97.4 million posted at 31 December 2012. This profit represented 11.6%
of sales for the year, compared with 8.0% in 2012.
At 31 December 2013, recurring adjusted1
profit from continuing operations amounted to €154.0 million, up
4.7% from €147.1 million a year earlier.
-
Net profit (loss) from discontinued operations
At 31 December 2013, net profit from discontinued operations totalled
€10.9 million. It primarily comprised the rebilling to Baxter of
production costs for OBI-1 clinical samples prior to the effective
transfer of the production site and staff, the negotiated repayment of
advisory fees paid by Ipsen during the joint asset-sale process with
Inspiration Biopharmaceuticals Inc., and the tax impact related to the
compensation paid by the Group to the US subsidiary that sold the assets.
At 31 December 2012, the net loss from discontinued operations totalled
€124.8 million. The net loss included €16.7 million in depreciation
charge from discontinued operations comprised of non-recurring losses on
Group-held receivables from the rebilling of OBI-1 industrial
development costs in the second and third quarters of the year, rebilled
expenses for setting up the European operations, and a €10.6 million
gain from the accelerated recognition of deferred income recorded during
the 2010 transaction with Inspiration Biopharmaceuticals Inc. following
the OBI-1 sub-license agreement. The impairment losses recognised on
assets held for sale stemmed from a €20.0 million provision for
property, plant and equipment at the Milford site, an €18.0 million
provision for intangible assets related to OBI-1 and IBI1001 rights,
€85.0 million in losses on convertible bonds, and a €6.0 million loss
related to the Inspiration Biopharmaceuticals Inc. warrant, which the
Group waived. The tax impact from these non-recurring losses, net of the
accelerated deferred income, was a €36.0 million tax credit. The net
loss also included the €21.7 million share of losses in Inspiration
Biopharmaceuticals Inc., which was recognised until it was reclassified
in assets held for sale.
As a result of the items above, consolidated net profit was €153.1
million (€152.5 million attributable to Ipsen S.A. shareholders),
compared to a €27.5 million consolidated net loss (€27.9 million loss
attributable to Ipsen S.A shareholders) at 31 December 2012.
At 31 December 2013, recurring adjusted1
consolidated net profit amounted to €154.0 million, up 4.7% over the
€147.1 million recorded the previous year.
1 See appendix 4
At 31 December 2013, basic earnings attributable to the Group amounted
to €1.84 per share, up from basic EPS of (€0.34) a year earlier.
Recurring adjusted1 basic earnings per share
attributable to the Group amounted to €1.85 at 31 December 2013, up 5.1%
year-on-year.
-
Milestone payments received in cash but not yet recognised in the
Group income statement
At 31 December 2013, the total of milestone payments received in cash by
the Group but not yet recognised as other revenues in the income
statement amounted to €125.7 million, compared with €152.4 million a
year earlier.
The Group recorded no new deferred income from its partnerships in 2013.
These deferred revenues will be recognised in the Group's future income
statements as follows:
(in million euros)
|
|
31 December 2013
|
|
31 December 2012
|
|
|
|
restated**
|
|
Total *
|
|
125.7
|
|
152.4
|
|
Deferred revenues will be recognised over time as follows:
|
|
|
|
|
|
In the year n+1
|
|
21.7
|
|
22.4
|
|
In the years n+2 and subsequent
|
|
104.0
|
|
130.0
|
|
* Amounts converted at average exchange rates respectively at 31
December 2013 and 31 December 2012
** For purposes of comparison between the two financial years, the 2012
income statement has been restated in accordance with IAS 19 revised
(see appendix 5)
CASH FLOW AND CAPITAL
The consolidated cash flow statement at 31 December 2013 shows that the
Group's operating activities generated net cash flow from continuing
operations of €181.4 million, up €16.4 million year-on-year.
Analysis of the Group's cash flow statement
(in million euros)
|
|
31 December 2013
|
|
31 December 2012
|
|
|
|
restated*
|
|
- Cash flow from operating activities before changes in working
capital requirement
|
|
201.6
|
|
175.3
|
|
- (Increase) / decrease in working capital requirement for operations
|
|
(20.1)
|
|
(10.3)
|
|
o Net cash flow from operating activities
|
|
181.4
|
|
165.0
|
|
- Net investments in tangible and intangible assets
|
|
(62.3)
|
|
(76.5)
|
|
- Convertible note subscriptions
|
|
-
|
|
(0.2)
|
|
- Other cash flow from investments
|
|
(41.4)
|
|
11.8
|
|
o Net cash provided (used) by investment activities
|
|
(103.7)
|
|
(64.8)
|
|
o Net cash provided (used) by financing activities
|
|
(76.5)
|
|
(73.2)
|
|
o Net cash provided (used) by discontinued operations
|
|
6.7
|
|
(56.2)
|
|
CHANGES IN CASH AND CASH EQUIVALENTS
|
|
7.9
|
|
(29.2)
|
|
Opening cash and cash equivalents
|
|
113.3
|
|
144.8
|
|
Impact of exchange rate fluctuations
|
|
4.1
|
|
(2.3)
|
|
Closing cash and cash equivalents
|
|
125.4
|
|
113.3
|
|
* For purposes of comparison between the two financial years, the 2012
consolidated cash flow statement has been restated in accordance with
IAS 19 revised.
-
Net cash flow from operating activities
In 2013, cash flow from operating activities before changes in working
capital requirement amounted to €201.6 million, up from the €175.3
million generated in 2012.
Working capital requirement for operating activities amounted to €20.1
million in 2013, compared with €10.3 million the prior year. The 2013
increase stemmed from the following items:
-
In 2013, inventories decreased by €2.9 million, versus an increase of
€7.1 million in 2012. The decline resulted from the implementation of
action plans aimed at improving productivity;
-
In 2013, trade receivables grew by €1.8 million, versus a decrease of
€10.1 million at 31 December 2012. The increase stemmed primarily from
the increase in commercial activity of the Russian affiliate, which
was offset by the collection of trade receivables in Southern Europe
and the unblocking of the economic situation in some Middle Eastern
countries;
-
In 2013, trade payables decreased by €4.6 million, versus an increase
of €15.0 million in 2012. The difference resulted from lower external
costs during the year, mainly as a result of the primary care
restructuring plan in France and the strategic reallocation of
resources;
-
In 2013, the net change in other operating assets and liabilities
comprised the use of €30.8 million, versus a use of €10.9 million in
2012. The Group recorded no new deferred revenues from its
partnerships in 2013 or 2012. Conversely, in 2013, the Group
recognised €21.9 million in deferred revenues from its partnerships,
compared with €24.5 million in 2012;
-
The change in net tax liability in 2013 represented a source of funds
totalling €14.2 million. The change resulted primarily from the
reimbursement in 2013 of an excess amount of tax paid for the fiscal
year 2012.
-
Net cash flow used by investment activities
In 2013, net cash used by investment activities amounted to €103.7
million, compared with a net use of €64.8 million in the prior year. It
included:
-
Investments in tangible and intangible assets, net of disposals,
totalling €62.3 million, versus €76.5 million at 31 December 2012.
This cash outflow mainly included:
-
€42.0 million in acquisitions of property, plant and equipment,
compared with €49.0 million in 2012. These acquisitions consisted
primarily of investments required to maintain the Group's
production equipment, as well as investments in capacity, notably
at the Signes, Dublin and Wrexham industrial sites;
-
€20.4 million in investments in intangible assets, versus €27.7
million in 2012, chiefly as part of the Group's partnership
policy, in particular with Active Biotech for the rights of
tasquinimod (€12,0 million), and Mayoly Spindler for its
cross-partnership with Ipsen in the primary care business in
France.
-
The use of €28.7 million for other investment activities, including
€26.2 million to acquire Syntaxin Ltd. on 12 July 2013.
-
A €12.7 million decrease in working capital requirement for investment
activities, corresponding mainly to the recognition of a milestone
payment to Active Biotech for tasquinimod in 2013 and which was
recognised in 2012.
-
Net cash flow from investing activities
In 2013, net cash used in financing activities totalled €76.5 million,
down from a net use of €73.2 million in 2012. The Group paid out €66.9
million in dividends in 2013, versus €67.5 million paid out in the
previous year.
-
Net cash from discontinued operations
At 31 December 2013, net cash provided (used) by discontinued operations
related to Inspiration Biopharmaceuticals Inc. amounted to a net source
of funds totalling €6.7 million, versus a net use of funds totalling
€56.2 million the previous year.
(in million euros)
|
|
31 December
|
|
31 December 2012
|
|
|
|
2013
|
|
restated*
|
|
- Cash flow from operating activities before changes in working
capital requirement
|
|
7.7
|
|
(3.5)
|
|
- (Increase) / decrease in working capital requirement for
operations held for sale
|
|
(1.0)
|
|
(17.3)
|
|
o Net cash flow provided (used) by operations held for sale
|
|
6.7
|
|
(20.8)
|
|
- Net investments in tangible and intangible assets
|
|
-
|
|
(5.8)
|
|
- Convertible note subscriptions
|
|
-
|
|
(26.7)
|
|
- Other cash flow from investments
|
|
-
|
|
(2.9)
|
|
o Net cash provided (used) by investment activities
|
|
-
|
|
(35.4)
|
|
o Net cash provided (used) by financing activities
|
|
-
|
|
-
|
|
CHANGES IN CASH AND CASH EQUIVALENTS
|
|
6.7
|
|
(56.2)
|
|
* For purposes of comparison between the two financial years, the 2012
consolidated cash flow statement has been restated in accordance with
IAS 19 revised
Net cash provided (used) by operations held for sale breaks down as
follows:
-
In 2013, net cash provided (used) by operations amounted to a net
source of funds totalling €6.7 million, compared with a net use of
funds of €20.8 million a year earlier. The result stemmed mainly from
the recovery of OBI-1 sales rights in the amount of USD 22.5 million,
as part of the strategic partnership agreement renegotiated with
Inspiration Biopharmaceuticals Inc. on 21 August 2012. It also
resulted from cash generated by the supply of clinical samples to
Baxter.
-
At 31 December 2012, net cash provided (used) by investment activities
amounted to a use of funds totalling €35.4 million, primarily owing to
the subscription by Ipsen of €26.7 million in convertible bonds issued
by Inspiration Biopharmaceuticals Inc. and the €6.1 million
acquisition of commercial rights on IB1001-related intangible assets.
Analysis of the Group's treasury
|
|
|
|
31 December 2012
|
|
(in million euros)
|
|
31 December 2013
|
|
restated*
|
|
Cash
|
|
63.1
|
|
58.6
|
|
Short-term investments
|
|
67.8
|
|
45.1
|
|
Interest-bearing deposits
|
|
0.1
|
|
10.0
|
|
Cash and cash equivalents
|
|
131.0
|
|
113.6
|
|
Bank overdrafts - liabilities
|
|
(5.6)
|
|
(0.4)
|
|
Closing net cash and cash equivalents
|
|
125.4
|
|
113.3
|
|
Bank loans
|
|
-
|
|
-
|
|
Other financial liabilities
|
|
12.3
|
|
15.9
|
|
Non-current liabilities
|
|
12.3
|
|
15.9
|
|
Bank loans
|
|
4.0
|
|
4.0
|
|
Financial liabilities
|
|
3.5
|
|
4.5
|
|
Current liabilities
|
|
7.5
|
|
8.5
|
|
Debt
|
|
19.9
|
|
24.4
|
|
Derivative financial instruments
|
|
(0.2)
|
|
(1.1)
|
|
NET CASH AND CASH EQUIVALENTS (1)
|
|
105.7
|
|
90.0
|
|
* For purposes of comparison between the two financial years, the 2012
consolidated cash flow statement has been restated in accordance with
IAS 19 revised
(1) Net cash and cash equivalents: Cash and cash equivalents
and securities held for sale, less bank overdrafts, bank loans and other
financial liabilities, with derivative financial instruments added back
In January 2012, Ipsen S.A. signed a five-year, €400.0 million loan with
a bank syndicate. This single-currency credit line was established to
meet the general financing needs of the company's operations. At the
initiative of the borrower, the line may be drawn for short-term periods
of one, two, three or six months or for any other duration subject to
agreement between Ipsen S.A. and the facility agent, to better adapt the
facility to the Group's cash flow profile.
As a result, the Group ended the line contracted in June 2008 without
having to pay any penalties.
The total amount of the drawdowns at all times must be below the credit
line ceiling, which remains constant over the duration of the contract.
Under the terms and conditions of the agreement, and in addition to the
usual contractual clauses, the Group committed to staying within maximum
levels of the Net-debt-to-equity and Net-debt-to-EBITDA ratios in its
consolidated financial statements at the end of each financial half
year. The covenant ratios are as follows, as per the credit agreement:
-
Net debt to equity: 1
-
Net debt to EBITDA1: 3
In the event of default, the bank syndicate may demand early repayment
of the loan agreement.
At 31 December 2013, the Group had a positive net cash position. As a
result, the net-debt-to-equity and net-debt-to-EBITDA1
covenant ratios had no significance.
1 EBITDA: Earnings Before Interest, Taxes, Depreciation and
Amortisation
APPENDIX 1
-
Consolidated income statement
(in million euros)
|
|
31 December
|
|
31 December
|
|
|
|
2013
|
|
2012 restated*
|
|
Net sales
|
|
1,224.8
|
|
1,219.5
|
|
Other revenues
|
|
57.0
|
|
57.9
|
|
Revenue
|
|
1,281.8
|
|
1,277.4
|
|
Cost of goods sold
|
|
(253.4)
|
|
(254.3)
|
|
Research and development expenses
|
|
(259.1)
|
|
(248.2)
|
|
Selling expenses
|
|
(451.3)
|
|
(473.0)
|
|
General and administrative expenses
|
|
(103.8)
|
|
(99.1)
|
|
Other operating income
|
|
5.7
|
|
5.6
|
|
Other operating expenses
|
|
(12.0)
|
|
(25.8)
|
|
Amortisation of intangible assets (**)
|
|
(4.4)
|
|
(5.8)
|
|
Restructuring costs
|
|
(0.2)
|
|
(62.1)
|
|
Impairment losses
|
|
(12.6)
|
|
2.4
|
|
Operating income
|
|
190.7
|
|
117.1
|
|
Investment income
|
|
8.0
|
|
1.0
|
|
Financing costs
|
|
(2.2)
|
|
(2.3)
|
|
Net financing costs
|
|
5.8
|
|
(1.3)
|
|
Other financial income and expense
|
|
(14.8)
|
|
6.8
|
|
Income taxes
|
|
(39.6)
|
|
(25.2)
|
|
Share of profit (loss) from associated companies
|
|
0.0
|
|
0.0
|
|
Net profit (loss) from continuing operations
|
|
142.2
|
|
97.4
|
|
Net profit (loss) from discontinued operations
|
|
10.9
|
|
(124.8)
|
|
Consolidated net profit
|
|
153.1
|
|
(27.5)
|
|
- Attributable to shareholders of Ipsen
|
|
152.5
|
|
(27.9)
|
|
- Minority interests
|
|
0.6
|
|
0.5
|
|
|
|
|
|
|
|
Basic earnings per share, continuing operations (in € per share)
|
|
1.71
|
|
1.17
|
|
Diluted earnings per share, continuing operations (in € per share)
|
|
1.70
|
|
1.16
|
|
|
|
|
|
|
|
Basic earnings per share, discontinued operations (in € per share)
|
|
0.13
|
|
(1.50)
|
|
Diluted earnings per share, discontinued operations (in € per share)
|
|
0.13
|
|
(1.50)
|
|
|
|
|
|
|
|
Basic earnings per share (in € per share)
|
|
1.84
|
|
(0.34)
|
|
Diluted earnings per share (in € per share)
|
|
1.83
|
|
(0.33)
|
|
(*) For purposes of comparison between the two financial years, the 2012
income statement has been restated in accordance with IAS 19 revised
(see appendix 5)
(**) Excluding software
APPENDIX 2
-
Consolidated balance sheet before net profit allocation
(in million euros)
|
|
31 December
|
|
31 December 2012
|
|
|
|
2013
|
|
restated*
|
|
ASSETS
|
|
|
|
|
|
Goodwill
|
|
310.7
|
|
298.2
|
|
Other intangible assets
|
|
144.8
|
|
129.2
|
|
Property, plant & equipment
|
|
287.5
|
|
281.8
|
|
Equity investments
|
|
6.7
|
|
12.0
|
|
Investments in associated companies
|
|
-
|
|
-
|
|
Non-current financial assets
|
|
1.5
|
|
-
|
|
Other non-current assets
|
|
9.7
|
|
18.7
|
|
Deferred tax assets
|
|
202.5
|
|
215.6
|
|
Total non-current assets
|
|
963.5
|
|
955.5
|
|
Inventories
|
|
121.5
|
|
127.9
|
|
Trade receivables
|
|
243.5
|
|
256.3
|
|
Current tax assets
|
|
42.8
|
|
54.4
|
|
Other current assets
|
|
60.3
|
|
53.6
|
|
Current financial assets
|
|
0.2
|
|
0.5
|
|
Cash and cash equivalents
|
|
131.0
|
|
113.6
|
|
Assets of discontinued operations
|
|
2.6
|
|
-
|
|
Total current assets
|
|
601.8
|
|
606.3
|
|
TOTAL ASSETS
|
|
1,565.3
|
|
1,561.9
|
|
|
|
|
|
|
|
EQUITY AND LIABILITIES
|
|
|
|
|
|
Share capital
|
|
84.2
|
|
84.3
|
|
Additional paid-in capital and consolidated reserves
|
|
743.4
|
|
844.6
|
|
Net profit for the period
|
|
152.5
|
|
(27.9)
|
|
Exchange differences
|
|
(8.7)
|
|
1.6
|
|
Equity attributable to Ipsen shareholders
|
|
971.5
|
|
902.5
|
|
Attributable to minority interests
|
|
2.2
|
|
2.0
|
|
Total shareholders' equity
|
|
973.7
|
|
904.5
|
|
Retirement benefit obligation
|
|
45.7
|
|
42.7
|
|
Provisions
|
|
45.0
|
|
25.6
|
|
Bank loans
|
|
-
|
|
-
|
|
Other financial liabilities
|
|
12.3
|
|
15.9
|
|
Deferred tax liabilities
|
|
6.8
|
|
2.5
|
|
Other non-current liabilities
|
|
105.6
|
|
133.8
|
|
Total non-current liabilities
|
|
215.4
|
|
220.4
|
|
Provisions
|
|
20.7
|
|
66.2
|
|
Bank loans
|
|
4.0
|
|
4.0
|
|
Financial liabilities
|
|
3.5
|
|
4.5
|
|
Trade payables
|
|
154.8
|
|
159.8
|
|
Current tax liabilities
|
|
5.8
|
|
3.3
|
|
Other current liabilities
|
|
181.7
|
|
198.3
|
|
Bank overdrafts
|
|
5.6
|
|
0.4
|
|
Liabilities of discontinued operations
|
|
-
|
|
0.5
|
|
Total current liabilities
|
|
376.2
|
|
437.0
|
|
TOTAL EQUITY & LIABILITIES
|
|
1,565.3
|
|
1,561.9
|
|
(*) For purposes of comparison between the two financial years, the 2012
consolidated balance sheet has been restated in accordance with IAS 19
revised (see appendix 5)
APPENDIX 3
-
Consolidated cash flow statement
|
|
31 December 2013
|
|
31 December 2012 restated*
|
|
|
|
Continuing
|
|
Operations held for
|
|
|
|
Continuing
|
|
Operations held for
|
|
|
|
(in million euros)
|
|
operations
|
|
sale / discontinued
|
|
Total
|
|
operations
|
|
sale / discontinued
|
|
Total
|
|
|
|
|
|
operations
|
|
|
|
|
|
operations
|
|
|
|
Consolidated net profit
|
|
142.2
|
|
10.9
|
|
153.1
|
|
97.4
|
|
(124.8)
|
|
(27.5)
|
|
Share of profit (loss) from associated companies before impairment
losses
|
|
-
|
|
-
|
|
-
|
|
-
|
|
21.7
|
|
21.7
|
|
Net profit (loss) before share of profit (loss) from associated
companies
|
|
142.2
|
|
10.9
|
|
153.1
|
|
97.4
|
|
(103.2)
|
|
(5.8)
|
|
Non-cash and non-operating items
|
|
-
|
|
-
|
|
|
|
-
|
|
-
|
|
|
|
- Depreciation, amortisation, provisions
|
|
25.6
|
|
0.1
|
|
25.7
|
|
70.2
|
|
-
|
|
70.2
|
|
- Impairment losses included in operating income and net financial
income
|
|
12.6
|
|
-
|
|
12.6
|
|
(2.4)
|
|
125.4
|
|
123.1
|
|
- Change in fair value of financial derivatives
|
|
(0.1)
|
|
-
|
|
(0.1)
|
|
(2.5)
|
|
-
|
|
(2.5)
|
|
- Net gains or losses on disposals of non-current assets
|
|
0.6
|
|
0.1
|
|
0.7
|
|
1.9
|
|
-
|
|
1.9
|
|
- Share of government grants released to profit and loss
|
|
(0.1)
|
|
-
|
|
(0.1)
|
|
(0.1)
|
|
-
|
|
(0.1)
|
|
- Foreign exchange differences
|
|
3.4
|
|
-
|
|
3.4
|
|
(1.4)
|
|
6.1
|
|
4.6
|
|
- Change in deferred taxes
|
|
11.6
|
|
(3.4)
|
|
8.2
|
|
7.7
|
|
(31.8)
|
|
(24.1)
|
|
- Share-based payment expense
|
|
5.0
|
|
-
|
|
5.0
|
|
4.6
|
|
-
|
|
4.6
|
|
- Gain or (loss) on sales of treasury shares
|
|
0.2
|
|
-
|
|
0.2
|
|
0.1
|
|
-
|
|
0.1
|
|
- Other non-cash items
|
|
0.4
|
|
-
|
|
0.4
|
|
(0.2)
|
|
-
|
|
(0.2)
|
|
Cash flow from operating activities before changes in working
capital requirement
|
|
201.6
|
|
7.7
|
|
209.3
|
|
175.3
|
|
(3.5)
|
|
171.8
|
|
- (Increase)/decrease in inventories
|
|
2.9
|
|
-
|
|
2.9
|
|
(7.1)
|
|
-
|
|
(7.1)
|
|
- (Increase)/decrease in trade receivables
|
|
(1.8)
|
|
-
|
|
(1.8)
|
|
10.1
|
|
-
|
|
10.1
|
|
- Increase/(decrease) in trade payables
|
|
(4.6)
|
|
-
|
|
(4.6)
|
|
15.0
|
|
-
|
|
15.0
|
|
- Net change in income tax liability
|
|
14.2
|
|
(0.2)
|
|
13.9
|
|
(17.4)
|
|
-
|
|
(17.4)
|
|
- Net change in other operating assets and liabilities
|
|
(30.8)
|
|
(0.7)
|
|
(31.5)
|
|
(10.9)
|
|
(17.3)
|
|
(28.2)
|
|
Change in working capital requirement related to operating
activities
|
|
(20.1)
|
|
(1.0)
|
|
(21.1)
|
|
(10.3)
|
|
(17.3)
|
|
(27.6)
|
|
NET CASH PROVIDED (USED) BY OPERATING ACTIVITIES
|
|
181.4
|
|
6.7
|
|
188.1
|
|
165.0
|
|
(20.8)
|
|
144.2
|
|
Acquisition of property, plant & equipment
|
|
(42.0)
|
|
-
|
|
(42.0)
|
|
(49.0)
|
|
-
|
|
(49.0)
|
|
Acquisition of intangible assets
|
|
(20.4)
|
|
-
|
|
(20.4)
|
|
(27.7)
|
|
(6.1)
|
|
(33.8)
|
|
Proceeds from disposal of intangible assets and property, plant &
equipment
|
|
0.2
|
|
-
|
|
0.2
|
|
0.3
|
|
0.3
|
|
0.6
|
|
Acquisition of shares in non-consolidated companies
|
|
0.0
|
|
-
|
|
0.0
|
|
(0.4)
|
|
-
|
|
(0.4)
|
|
Convertible note subscriptions
|
|
-
|
|
-
|
|
-
|
|
(0.2)
|
|
(26.7)
|
|
(26.9)
|
|
Proceeds from sales of investment securities
|
|
-
|
|
-
|
|
-
|
|
13.9
|
|
-
|
|
13.9
|
|
Payments to post-employment benefit plans
|
|
(2.3)
|
|
-
|
|
(2.3)
|
|
(6.1)
|
|
-
|
|
(6.1)
|
|
Impact of changes in the consolidation scope
|
|
(26.2)
|
|
-
|
|
(26.2)
|
|
-
|
|
-
|
|
-
|
|
Other cash flow related to investment activities
|
|
(0.4)
|
|
-
|
|
(0.4)
|
|
(0.5)
|
|
(2.9)
|
|
(3.4)
|
|
Deposits paid
|
|
0.3
|
|
-
|
|
0.3
|
|
(0.4)
|
|
-
|
|
(0.4)
|
|
Change in working capital related to operating activities
|
|
(12.7)
|
|
-
|
|
(12.7)
|
|
5.3
|
|
-
|
|
5.3
|
|
NET CASH PROVIDED (USED) BY INVESTMENT ACTIVITIES
|
|
(103.7)
|
|
-
|
|
(103.7)
|
|
(64.8)
|
|
(35.4)
|
|
(100.2)
|
|
Additional long-term borrowings
|
|
-
|
|
-
|
|
0.0
|
|
-
|
|
-
|
|
0.0
|
|
Repayment of long-term borrowings
|
|
(0.2)
|
|
-
|
|
(0.2)
|
|
(0.3)
|
|
-
|
|
(0.3)
|
|
Net change in short-term borrowings
|
|
0.1
|
|
-
|
|
0.1
|
|
-
|
|
-
|
|
-
|
|
Capital increase by Ipsen
|
|
0.8
|
|
-
|
|
0.8
|
|
-
|
|
-
|
|
-
|
|
Treasury shares
|
|
(16.4)
|
|
-
|
|
(16.4)
|
|
0.2
|
|
-
|
|
0.2
|
|
Dividends paid by Ipsen
|
|
(66.6)
|
|
-
|
|
(66.6)
|
|
(66.5)
|
|
-
|
|
(66.5)
|
|
Dividends paid by subsidiaries to minority interests
|
|
(0.3)
|
|
-
|
|
(0.3)
|
|
(1.0)
|
|
-
|
|
(1.0)
|
|
Deposits received
|
|
0.0
|
|
-
|
|
0.0
|
|
0.0
|
|
-
|
|
0.0
|
|
DIP financing
|
|
7.1
|
|
-
|
|
7.1
|
|
(7.2)
|
|
-
|
|
(7.2)
|
|
Change in working capital related to operating activities
|
|
(1.0)
|
|
-
|
|
(1.0)
|
|
1.6
|
|
-
|
|
1.6
|
|
NET CASH PROVIDED (USED) BY FINANCING ACTIVITIES
|
|
(76.5)
|
|
-
|
|
(76.5)
|
|
(73.2)
|
|
-
|
|
(73.2)
|
|
CHANGE IN CASH AND CASH EQUIVALENTS
|
|
1.2
|
|
6.7
|
|
7.9
|
|
27.0
|
|
(56.2)
|
|
(29.2)
|
|
Opening cash and cash equivalents
|
|
113.3
|
|
-
|
|
113.3
|
|
144.8
|
|
-
|
|
144.8
|
|
Impact of exchange rate fluctuations
|
|
4.1
|
|
-
|
|
4.1
|
|
(2.3)
|
|
-
|
|
(2.3)
|
|
Closing cash and cash equivalents
|
|
118.6
|
|
6.7
|
|
125.4
|
|
169.5
|
|
(56.2)
|
|
113.3
|
|
* For purposes of comparison between the two financial years, the 2012
cash flow statement has been restated in accordance with IAS 19 revised
APPENDIX 4
-
Reconciliation of the income statement at 31 December 2013 and the
recurring adjusted income statement at 31 December 2013
|
|
31 December 2013 Adjusted recurring
|
|
Operations held for sale (1)
|
|
Other non- recurring items (2)
|
|
31 December 2013
|
|
(in million euros)
|
|
|
|
% sales
|
|
|
|
|
|
% sales
|
|
Revenue
|
|
1,281.8
|
|
104.7%
|
|
|
|
|
|
1,281.8
|
|
104.7%
|
|
Cost of goods sold
|
|
(253.4)
|
|
-20.7%
|
|
|
|
|
|
(253.4)
|
|
-20.7%
|
|
Research and development expenses
|
|
(259.1)
|
|
-21.2%
|
|
|
|
|
|
(259.1)
|
|
-21.2%
|
|
Selling expenses
|
|
(451.3)
|
|
-36.8%
|
|
|
|
|
|
(451.3)
|
|
-36.8%
|
|
General and administrative expenses
|
|
(103.8)
|
|
-8.5%
|
|
|
|
|
|
(103.8)
|
|
-8.5%
|
|
Other operating income
|
|
4.4
|
|
0.4%
|
|
|
|
1.4
|
|
5.7
|
|
0.5%
|
|
Other operating expenses
|
|
(5.9)
|
|
-0.5%
|
|
|
|
(6.0)
|
|
(12.0)
|
|
-1.0%
|
|
Amortisation of intangible assets (3)
|
|
(4.1)
|
|
-0.3%
|
|
|
|
(0.3)
|
|
(4.4)
|
|
-0.4%
|
|
Restructuring costs
|
|
0.0
|
|
0.0%
|
|
|
|
(0.2)
|
|
(0.2)
|
|
0.0%
|
|
Impairment losses
|
|
|
|
-
|
|
|
|
(12.6)
|
|
(12.6)
|
|
-1.0%
|
|
Operating income
|
|
208.6
|
|
17.0%
|
|
|
|
(17.9)
|
|
190.7
|
|
15.6%
|
|
Financial income/(expense)
|
|
(14.7)
|
|
-1.2%
|
|
|
|
5.7
|
|
(9.0)
|
|
-0.7%
|
|
Income taxes
|
|
(39.9)
|
|
-3.3%
|
|
|
|
0.3
|
|
(39.6)
|
|
-3.2%
|
|
Share of profit (loss) from associated companies
|
|
|
|
0.0%
|
|
|
|
|
|
|
|
0.0%
|
|
Net profit (loss) from continuing operations
|
|
154.0
|
|
12.6%
|
|
|
|
(11.8)
|
|
142.2
|
|
11.6%
|
|
Net profit (loss) from discontinued operations
|
|
|
|
0.0%
|
|
10.9
|
|
|
|
10.9
|
|
0.9%
|
|
Consolidated net profit
|
|
154.0
|
|
12.6%
|
|
10.9
|
|
(11.8)
|
|
153.1
|
|
12.5%
|
|
- Attributable to shareholders of Ipsen S.A.
|
|
153.5
|
|
|
|
10.9
|
|
(11.8)
|
|
152.5
|
|
|
|
- Minority interests
|
|
0.6
|
|
|
|
|
|
|
|
0.6
|
|
|
|
- Basic earnings per share
|
|
1.85
|
|
|
|
|
|
|
|
1.84
|
|
|
|
(1) Impact on profit from discontinuing haematology
operations (Inspiration Biopharmaceuticals Inc.) and from costs related
to the supply of clinical samples to Baxter
(2) Other non-recurring items included:
-
Impairment losses recognised during the period, as described in the
"Impairment losses" paragraph;
-
Certain non-recurring fees incurred as part of the acquisition of
Syntaxin Ltd.;
-
Non-recurring costs to restructure the Group's North American
commercial subsidiary and the provision release related to the
restructuring of the primary care business in France;
-
Settlement of a trade dispute with a partner;
-
Settlement of an administrative proceeding brought against the Group;
-
The repayment of Debtor-in-Possession (DIP)-type financing granted by
Ipsen to Inspiration Biopharmaceuticals Inc. at the end of 2012,
following the sale of its hemophilia assets to Baxter and Cangene, and
€2.0 million in depreciation expense on convertible bonds subscribed
by the Group to develop a neurology programme
(3) Excluding software
-
Reconciliation of the restated income statement at 31 December 2012
and the restated recurring adjusted income statement at 31 December
2012
|
|
31 December 2012, recurring adjusted* restated
|
|
Operations held for sale (1)
|
|
Other non- recurring items (2)
|
|
31 December 2012 restated*
|
|
(in million euros)
|
|
|
|
% sales
|
|
|
|
|
|
% sales
|
|
Revenue
|
|
1,277.4
|
|
104.7%
|
|
|
|
|
|
1,277.4
|
|
104.7%
|
|
Cost of goods sold
|
|
(254.3)
|
|
-20.9%
|
|
|
|
|
|
(254.3)
|
|
-20.9%
|
|
Research and development expenses
|
|
(248.2)
|
|
-20.3%
|
|
|
|
|
|
(248.2)
|
|
-20.3%
|
|
Selling expenses
|
|
(473.0)
|
|
-38.8%
|
|
|
|
|
|
(473.0)
|
|
-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)
|
|
(3.3)
|
|
-0.3%
|
|
|
|
(2.5)
|
|
(5.8)
|
|
-0.5%
|
|
Restructuring costs
|
|
1.0
|
|
0.1%
|
|
|
|
(63.1)
|
|
(62.1)
|
|
-5.1%
|
|
Impairment losses
|
|
|
|
0.0%
|
|
|
|
2.4
|
|
2.4
|
|
0.2%
|
|
Operating income
|
|
198.3
|
|
16.3%
|
|
|
|
(81.2)
|
|
117.1
|
|
9.6%
|
|
Financial income/(expense)
|
|
(6.5)
|
|
-0.5%
|
|
|
|
11.9
|
|
5.4
|
|
0.4%
|
|
Income taxes
|
|
(44.8)
|
|
-3.7%
|
|
|
|
19.6
|
|
(25.2)
|
|
-2.1%
|
|
Share of profit (loss) from associated companies
|
|
|
|
0.0%
|
|
|
|
|
|
|
|
0.0%
|
|
Net profit (loss) from continuing operations
|
|
147.1
|
|
12.1%
|
|
|
|
(49.7)
|
|
97.4
|
|
8.0%
|
|
Net profit (loss) from discontinued operations
|
|
|
|
0.0%
|
|
(124.8)
|
|
|
|
(124.8)
|
|
-10.2%
|
|
Consolidated net profit
|
|
147.1
|
|
12.1%
|
|
(124.8)
|
|
(49.7)
|
|
(27.5)
|
|
-2.3%
|
|
- Attributable to shareholders of Ipsen S.A.
|
|
146.6
|
|
|
|
(124.8)
|
|
(49.7)
|
|
(27.9)
|
|
|
|
- Minority interests
|
|
0.5
|
|
|
|
|
|
|
|
0.5
|
|
|
|
- Basic earnings per share
|
|
1.76
|
|
|
|
|
|
|
|
(0.34)
|
|
|
|
* For purposes of comparison between the two financial years, the 2012
income statement has been restated in accordance with IAS 19 revised
(1) Impact on profit (loss) from discontinuing haematology
operations (Inspiration Biopharmaceuticals Inc.)
(2) Other non-recurring items included:
-
Non-recurring fees incurred as part of executing the strategy
announced 9 June 2011;
-
Non-recurring restructuring costs arising from the relocation of the
Group's North American subsidiary to the East Coast and from the
primary care business in France;
-
The settlement of a trade dispute with a partner;
-
An administrative proceeding brought against the Group;
-
Additional payments from the sale of PregLem shares.
(3) Excluding software
APPENDIX 5
-
Reconciliation of the income statement reported at 31 December 2012
and the restated income statement at 31 December 2012
|
|
|
|
Restatements
|
|
|
|
(in million euros)
|
|
31 December 2012
|
|
according to
|
|
31 December 2012
|
|
|
|
reported
|
|
IFRS IAS19
|
|
restated
|
|
|
|
|
|
revised
|
|
|
|
|
|
|
|
|
|
|
|
Sales of goods
|
|
1,219.5
|
|
-
|
|
1,219.5
|
|
Other revenues
|
|
57.9
|
|
-
|
|
57.9
|
|
Revenue
|
|
1,277.4
|
|
-
|
|
1,277.4
|
|
Cost of goods sold
|
|
(254.8)
|
|
0.4
|
|
(254.3)
|
|
Research and development expenses
|
|
(248.6)
|
|
0.4
|
|
(248.2)
|
|
Selling expenses
|
|
(473.5)
|
|
0.5
|
|
(473.0)
|
|
General and administrative expenses
|
|
(99.1)
|
|
-
|
|
(99.1)
|
|
Other operating income
|
|
5.6
|
|
-
|
|
5.6
|
|
Other operating expenses
|
|
(25.8)
|
|
-
|
|
(25.8)
|
|
Amortisation of intangible assets (1)
|
|
(5.8)
|
|
-
|
|
(5.8)
|
|
Restructuring costs
|
|
(63.1)
|
|
1.0
|
|
(62.1)
|
|
Impairment losses
|
|
2.4
|
|
-
|
|
2.4
|
|
Operating income
|
|
114.8
|
|
2.3
|
|
117.1
|
|
Investment income
|
|
1.0
|
|
-
|
|
1.0
|
|
Financing costs
|
|
(2.3)
|
|
-
|
|
(2.3)
|
|
Net financing costs
|
|
(1.3)
|
|
-
|
|
(1.3)
|
|
Other financial income and expense
|
|
6.8
|
|
-
|
|
6.8
|
|
Income taxes
|
|
(24.4)
|
|
(0.8)
|
|
(25.2)
|
|
Share of profit (loss) from associated companies
|
|
-
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
Net profit (loss) from continuing operations
|
|
95.8
|
|
1.6
|
|
97.4
|
|
|
|
|
|
|
|
|
|
Net profit (loss) from discontinued operations
|
|
(124.8)
|
|
-
|
|
(124.8)
|
|
|
|
|
|
|
|
|
|
Consolidated net profit
|
|
(29.0)
|
|
1.6
|
|
(27.5)
|
|
- Attributable to shareholders of Ipsen
|
|
(29.5)
|
|
1.6
|
|
(27.9)
|
|
- Minority interests
|
|
0.5
|
|
-
|
|
0.5
|
|
(1) Excluding software
-
Reconciliation of the balance sheet reported at 31 December 2012
and the restated balance sheet at 31 December 2012
|
|
31
|
|
Restatements
|
|
31
|
|
(in million euros)
|
|
December
|
|
according to
|
|
December
|
|
|
|
2012
|
|
IFRS IAS19
|
|
2012
|
|
|
|
reported
|
|
revised
|
|
restated
|
|
ASSETS
|
|
|
|
|
|
|
|
Goodwill
|
|
298.2
|
|
|
|
298.2
|
|
Other intangible assets
|
|
129.2
|
|
|
|
129.2
|
|
Property, plant & equipment
|
|
281.8
|
|
|
|
281.8
|
|
Equity investments
|
|
12.0
|
|
|
|
12.0
|
|
Investments in associated companies
|
|
|
|
|
|
|
|
Non-current financial assets
|
|
6.7
|
|
(6.7)
|
|
|
|
Other non-current assets
|
|
18.7
|
|
|
|
18.7
|
|
Deferred tax assets
|
|
208.2
|
|
7.5
|
|
215.6
|
|
Total non-current assets
|
|
954.7
|
|
0.8
|
|
955.5
|
|
Inventories
|
|
127.9
|
|
|
|
127.9
|
|
Trade receivables
|
|
256.3
|
|
|
|
256.3
|
|
Current tax assets
|
|
54.4
|
|
|
|
54.4
|
|
Other current assets
|
|
53.6
|
|
|
|
53.6
|
|
Current financial assets
|
|
0.5
|
|
|
|
0.5
|
|
Cash and cash equivalents
|
|
113.6
|
|
|
|
113.6
|
|
Assets of discontinued operations
|
|
|
|
|
|
|
|
Total current assets
|
|
606.3
|
|
|
|
606.3
|
|
TOTAL ASSETS
|
|
1,561.1
|
|
0.8
|
|
1,561.9
|
|
|
|
|
|
|
|
|
|
EQUITY AND LIABILITIES
|
|
|
|
|
|
|
|
Share capital
|
|
84.3
|
|
|
|
84.3
|
|
Additional paid-in capital and consolidated reserves
|
|
867.8
|
|
(23.2)
|
|
844.6
|
|
Net profit for the period
|
|
(29.5)
|
|
1.6
|
|
(27.9)
|
|
Exchange differences
|
|
1.6
|
|
|
|
1.6
|
|
Equity attributable to Ipsen shareholders
|
|
924.2
|
|
(21.7)
|
|
902.5
|
|
Attributable to minority interests
|
|
2.0
|
|
|
|
2.0
|
|
Total equity
|
|
926.3
|
|
(21.7)
|
|
904.5
|
|
Retirement benefit obligation
|
|
19.9
|
|
22.8
|
|
42.7
|
|
Provisions
|
|
25.6
|
|
|
|
25.6
|
|
Bank loans
|
|
|
|
|
|
|
|
Other financial liabilities
|
|
15.9
|
|
|
|
15.9
|
|
Deferred tax liabilities
|
|
2.8
|
|
(0.3)
|
|
2.5
|
|
Other non-current liabilities
|
|
133.8
|
|
|
|
133.8
|
|
Total non-current liabilities
|
|
197.9
|
|
22.5
|
|
220.4
|
|
Provisions
|
|
66.2
|
|
|
|
66.2
|
|
Bank loans
|
|
4.0
|
|
|
|
4.0
|
|
Financial liabilities
|
|
4.5
|
|
|
|
4.5
|
|
Trade payables
|
|
159.8
|
|
|
|
159.8
|
|
Current tax liabilities
|
|
3.3
|
|
|
|
3.3
|
|
Other current liabilities
|
|
198.3
|
|
|
|
198.3
|
|
Bank overdrafts
|
|
0.4
|
|
|
|
0.4
|
|
Liabilities of discontinued operations
|
|
0.5
|
|
|
|
0.5
|
|
Total current liabilities
|
|
437.0
|
|
|
|
437.0
|
|
TOTAL EQUITY & LIABILITIES
|
|
1,561.1
|
|
0.8
|
|
1,561.9
|
|
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20140227006855/en/
[ Back To TMCnet.com's Homepage ]
|