[February 03, 2015] |
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Ipsen: Sales in the Fourth Quarter and Full Year 2014
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today reported its sales for the
fourth quarter and the full year 2014.
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Unaudited IFRS consolidated sales
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4thquarter
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12 months
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%
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%
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%
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Variation
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%
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Variation
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(in million euros)
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2014
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2013
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Variation
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at
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2014
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2013
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Variation
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at
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constant
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constant
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currency
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currency
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SALES BY REGION
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Major Western European countries
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128.2
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121.5
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5.5%
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4.7%
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509.1
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497.3
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2.4%
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1.8%
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Other European countries
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79.9
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83.6
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-4.4%
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4.6%
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324.1
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329.4
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-1.6%
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3.6%
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North America
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21.2
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14.2
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49.4%
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36.3%
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79.2
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64.2
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23.2%
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23.7%
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Rest of the world
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77.8
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73.8
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5.4%
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0.4%
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362.5
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333.9
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8.6%
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10.4%
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Group Sales
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307.1
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293.0
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4.8%
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5.2%
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1274.8
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1 224.8
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4.1%
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5.7%
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SALES BY THERAPEUTIC AREA
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Specialty care
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228.8
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209.9
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9.0%
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8.5%
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947.1
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871.1
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8.7%
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9.9%
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Primary care
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74.2
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77.5
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-4.3%
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-1.5%
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311.9
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320.2
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-2.6%
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0.5%
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Total Drug Sales
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303.0
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287.4
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5.4%
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5.9%
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1259.0
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1 191.3
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5.7%
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7.4%
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Drug-related sales*
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4.1
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5.6
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-27.5%
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-28.5%
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15.9
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33.5
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-52.7%
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-53.0%
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Group Sales
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307.1
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293.0
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4.8%
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5.2%
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1274.8
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1 224.8
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4.1%
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5.7%
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* Active substances and raw materials. Drug-related sales are affected
by an unfavorable effect arising from the change in methodology for the
consolidation of sales of the Swiss company Linnea. Indeed, sales of
active ingredients and raw materials made by Linnea, partner on which
Ipsen and the Schwabe Group exercise joint control, will from now on be
consolidated under the equity method of accounting
1 Year-on-year growth excluding foreign exchange impacts (see
appendix)
Commenting on the full year 2014 sales performance, Marc de Garidel,
Chairman and Chief Executive Officer of Ipsen, said: "In 2014,
Specialty care sales grew 9.9%1, driven by the
acceleration of Somatuline® growth across all
geographies, Dysport® solid performance, and
the rebound of Decapeptyl® after a particularly
difficult year 2013. Moreover, Primary care started to level off thanks
to its emerging markets presence." Marc de Garidel added: "2014
was marked by key milestones for the Group with the approval of
Somatuline® in the United States for first line
treatment of pancreatic and gastrointestinal neuroendocrine tumors
(GEP-NET), the negotiation of an exclusive partnership with Galderma for
the development and marketing of neurotoxins, and the materialization of
our business development strategy with the acquisition of the European
rights to telotristat etiprate. 2015 looks just as rich with the global
launch of Somatuline® in GEP-NET, the potential
US launch of Dysport® in spasticity and the
tasquinimod phase III results in prostate cancer."
Highlights of the fourth quarter and full year
2014 sales
Note: Unless stated otherwise, all variations in sales are stated
excluding foreign exchange1 impacts.
Group drug sales grew 5.9% in the fourth quarter 2014 and 7.4%
for the year. Consolidated Group sales grew 5.2% to €307.1
million in the fourth quarter 2014 and 5.7% to €1,274.8 million euros
for the year.
Sales of Specialty care products reached €228.8 million in the
fourth quarter 2014, up 8.5% year-on-year. In 2014, sales amounted to
€947.1 million, up 9.9%. Sales in urology-oncology, endocrinology, and
neurology grew by respectively 6.7%, 14.0% and 8.8%. In 2014, the
relative weight of specialty care products continued to increase to
reach 74.3% of total Group sales, compared to 71.1% the previous year.
Sales of Decapeptyl® reached €73.2 million in
the fourth quarter 2014, down 4.2% year-on-year, and €316.6 million for
the full year 2014, up 6.5%. Sales growth in 2014 benefited from a
favorable comparison base due to weak product performance in the first
nine months 2013 in China and in the Middle East, where Ipsen had
limited the supply of its products due to the absence of payment
guarantees, but was penalized in the fourth quarter 2014 by the strong
pick-up in sales in these regions in the fourth quarter 2013. In 2014,
Decapeptyl® performance nonetheless took place in
a contracting pharmaceutical market in Europe, notably impacted by a
more frequent use of co-payment in Southern Europe and a slowdown in the
growth of Eastern European countries. As such, performance in France
suffered from a decrease in volumes sold and from the implementation of
a 4.0% price cut as of 1st April 2014.
Sales of Somatuline® reached €73.9 million in
the fourth quarter 2014, up 20.6% year-on-year. In 2014, sales of
Somatuline® grew 16.8% to €287.5 million, driven by strong
volume and value growth in the United States, strong volume growth in
Germany together with a reduction (from 16% to 7%) in mandatory rebates
on prescription drug sales, and solid volume momentum in the United
Kingdom. Somatuline® recorded good performance in Spain,
France, the Netherlands, Denmark and Belgium, and was penalized by a
price cut in Columbia.
Sales of Dysport® reached €59.2 million in the
fourth quarter 2014, up 7.7% year-on-year. In 2014, Dysport® sales
amounted to €254.5 million, up 8.6%, driven by the supply of the product
to Galderma for aesthetic use and by the solid volume performance of the
therapeutic and aesthetic segments in Brazil. Growth was affected by the
intensification of competitive intensity in South Korea and United
Kingdom, while benefiting in Germany from the reduction in mandatory
rebates.
Sales of Primary Care products reached €74.2 million, down 1.5%
year-on-year. In 2014, sales amounted to €311.9 million, up 0.5%. In
France, sales of Primary care products declined 9.9%, affected by two
7.5% consecutive price cuts on Smecta® and the launch of a
competing product to Tanakan® in March 2013. Internationally,
sales increased 5.2%, driven by solid performance in China, Algeria and
Russia, offsetting the decline in France. Primary care sales in France
accounted for 27.8% of the Group's total primary care sales, compared to
30.1% the previous year.
1 See appendix
Sales of Smecta® reached €26.8 million in the
fourth quarter 2014, down 7.3% year-on-year, mainly affected by the
interruption of direct sales in Algeria, replaced from now on by the
sales of the active principle to a local manufacturer, which are
recorded in Drug-related sales. Restated for this item, sales increased
1.8% over the quarter. In 2014, sales amounted to €121.4 million euros,
up 2.7%, driven by solid growth in Russia, Algeria and China, but
affected in France by the two 7.5% price cuts implemented in January and
July 2014 and a low level of gastroenteritis epidemic compared to last
year.
Sales of Tanakan® reached €15.0 million
euros in the fourth quarter 2014, down 9.7% year-on-year. In 2014, sales
amounted to €62.6 million euros, down 0.6%, driven by the good
performance of the product in Russia. The product's growth was penalized
by the launch of a second "me-too" product in France in 2013 and by a
change in the commercial model for Spain, where the product is now
distributed by a partner.
Sales of Forlax® reached €10.1 million in the
fourth quarter 2014, up 9.1% year-on-year. In 2014, sales amounted to
€38.5 million euros, flat year-on-year, affected by the reinforcement of
the "Tiers-Payant1" regulation in France and by the lower
sales to our partners marketing generic versions of the product.
1 With the "Tiers-Payant" regulation, the patient now pays
upfront for a branded drug and is reimbursed only later on
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.2 billion in 2014. 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 urology-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. Use of the words "believes,"
"anticipates" and "expects" and similar expressions are intended to
identify forward-looking statements, including the Group's expectations
regarding future events, including regulatory filings and
determinations. Moreover, the targets described in this document were
prepared without taking into account external growth assumptions and
potential future acquisitions, which may alter these parameters. These
objectives are based on data and assumptions regarded as reasonable by
the Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual results
may depart significantly from these targets given the occurrence of
certain risks and uncertainties, notably the fact that a promising
product in early development phase or clinical trial may end up never
being launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. The Group must face or might face
competition from generic products that might translate into a loss of
market share. Furthermore, the Research and Development process involves
several stages each of which involves the substantial risk that the
Group may fail to achieve its objectives and be forced to abandon its
efforts with regards to a product in which it has invested significant
sums. Therefore, the Group cannot be certain that 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. There can be no guarantees a product will receive the
necessary regulatory approvals or that the product will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Other risks and
uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation; global
trends toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approval; the
Group's ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of the Group's patents and other protections for
innovative products; and the exposure to litigation, including patent
litigation, and/or regulatory actions. The Group also depends on third
parties to develop and market some of its products which could
potentially generate substantial royalties; these partners could behave
in such ways which could cause damage to the Group's activities and
financial results. The Group cannot be certain that its partners will
fulfil their obligations. It might be unable to obtain any benefit from
those agreements. A default by any of the Group's partners could
generate lower revenues than expected. Such situations could have a
negative impact on the Group's business, financial position or
performance. The Group expressly disclaims any obligation or undertaking
to update or revise any forward looking statements, targets or estimates
contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such statements
are based, unless so required by applicable law. The Group's business is
subject to the risk factors outlined in its registration documents filed
with the French Autorité des Marchés Financiers.
APPENDIX
SALES EXCLUDING FOREIGN EXCHANGE IMPACTS
Unless stated otherwise, all variations in sales are stated excluding
foreign exchange impacts by restating the Q4 and full year 2013 figures
with the 2014 exchange rates.
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 2013
Registration Document available on its website (www.ipsen.com).
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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.
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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.
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Actual results may depart significantly from the objectives given that
a new product can appear to be promising at a development stage, or
after clinical trials, but never be launched on the market, or be
launched on the market but fail to sell, notably for regulatory or
competitive reasons.
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The Research and Development process typically lasts between eight and
twelve years from the date of discovery to a product being brought to
market. This process involves several stages; at each stage, there is
a substantial risk that the Group could fail to achieve its objectives
and be forced to abandon its efforts in respect of products in which
it has invested significant amounts. Thus, in order to develop viable
products from a commercial point of view, the Group must demonstrate,
by means of pre-clinical and clinical trials, that the molecules in
question are effective and are not harmful to humans. The Group cannot
be certain that favorable results obtained during pre-clinical trials
will subsequently be confirmed during clinical trials, or that the
results of clinical trials will be sufficient to demonstrate the
safety and efficacy of the product in question such that the required
marketing approvals can be obtained.
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The Group must deal with or may have to deal with competition (i) from
generic products, particularly in relation to Group products which are
not protected by patents, 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.
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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.
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The Group's strategy includes acquiring companies or assets which may
enable or facilitate access to new markets, research projects or
geographical regions or enable 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.
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The marketing of certain products by the Group has been and could be
affected by supply shortages and other disruptions. Such difficulties
may be of both a regulatory nature (the need to correct certain
technical problems in order to bring production sites into compliance
with applicable regulations) and a technical nature (difficulties in
obtaining supplies of satisfactory quality or difficulties in
manufacturing active ingredients or drugs complying with their
technical specifications on a sufficiently reliable and uniform
basis). This situation may result in inventory shortages and/or in a
significant reduction in the sales of one or more products. More
specifically, in their US Hopkinton facility, Lonza, our supplier of
IGF-1 (Increlex® drug substance), experienced manufacturing
issues with Increlex® which led in 2013 to supply
interruption in the US, Europe and the rest of the world.
Consultations with the National competent authorities of the European
Union have allowed a resupply in Europe early 2014. In the United
States, Ipsen has released a first batch of Increlex®'s
active ingredient on 2 June 2014 and a second one in September 2014.
Ipsen anticipates that additional lots will be released in the coming
months, as the company continues to work closely with the FDA to make
additional Increlex® lots available as soon as possible.
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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.
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In the normal course of business, the Group is or may be involved in
legal or administrative proceedings. Financial claims are or may be
brought against the Group in connection with some of these proceedings.
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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
During 2014, major developments included:
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On 10 January 2014 - Ipsen announced the appointment of
Jonathan Barnsley as Executive Vice President in charge of Technical
Operations. He is a member of the Executive Committee of the Ipsen
group. He took up his new position on April 1st, 2014,
reporting directly to Christel Bories, Deputy CEO of the Ipsen group.
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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.
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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.
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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).
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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.
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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
ROW5.
1 Ipsen 2013 estimates of US NET market
2 Commercial contribution excluding Increlex®
(mecasermin [rDNA origin]) Injection sales and revenues from US
collaboration withGalderma in aesthetic medicine
3 Latin America, Middle East and Asia (excl. China and Japan)
4 Truong D. et al. Mov. Disord., 2005; 20 (7) 783-791; Truong
et al., Parkinsonism Relat Disord. 2010 Jun;16(5):316-23
5 Latin America, Middle East and Asia (excl. China and Japan)
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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.
-
On 18 March 2014 - Ipsen announced positive results from its
phase IIa clinical trial assessing Dysport® in the
treatment of Neurogenic Detrusor Overactivity (NDO) in patients with
urinary incontinence not adequately managed by anticholinergics.
Results show that treatment with Dysport® was associated
with a mean reduction from baseline of urinary incontinence episodes
greater than 75%, 12 weeks after the injection, regardless of how the
drug is administered. These results were achieved with a single dose
of Dysport® 750 Units injected in either 15 or 30 sites in
the detrusor muscle. Efficacy was confirmed by improvement in
urodynamic parameters and quality of life. The safety profile observed
in the study is consistent with the safety profile expected in this
indication.
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On 20 March 2014 - Ipsen announced that Mayroy, its controlling
shareholder, had completed an institutional private placement of 5 888
290 shares representing c.7% of Ipsen's share capital, at a price of
€29.50 per share. As part of this transaction, Ipsen purchased 842 542
of its own shares (representing 1% of its share capital) to be
cancelled.Ipsen has been informed that the proceeds of this sale will
be used to partially finance the repurchase by Mayroy of the entire
stake held in its share capital by its minority shareholder, Opera
Finance Europe, a Luxembourg-registered company controlled by Mrs
Véronique Beaufour. Opera Finance Europe and its stakeholders do not
sit on the Board of Directors of Ipsen and play no active role in the
management of the Group. The repurchase of the balance of the stake of
Opera Finance Europe will be financed by the delivery by Mayroy of
Ipsen shares representing c.4% of Ipsen share capital. These shares
will be placed into an escrow account for a period of 12 months
following completion of the transaction.
As a result of this transaction, Ipsen's free-float increases to c.40%2
from c.30%. Mayroy's stake in Ipsen's share capital and voting rights
now amounts to c.57.6%3 and c.73.3%3 respectively.
The indirect stake held by Beech Tree (controlling shareholder of
Mayroy) in Ipsen has slightly increased. Ipsen has also been informed
that the shareholders' agreement between Beech Tree, its subsidiaries
and the Schwabe family, which was entered into on December 31, 2008 in
order to preserve the stability of Mayroy's controlling share ownership
structure, has been renewed until 30 June 2015.
-
On 9 April 2014 - Ipsen confirmed its eligibility for the
PEA-PME scheme, in accordance with the French decree n° 2014-283 of 4
March 2014. The Group complies with the thresholds set by the
legislator for eligibility to the PEA-PME scheme, namely having less
than 5,000 employees and total revenue below €1,500 million or total
assets below €2,000 million. As a consequence, investment in company
shares can be made through PEA-PME accounts, benefiting from the same
tax advantages as the traditional Equity Savings Plan (PEA). Ipsen was
included by Euronext in the CAC® PME index.
-
On 12 April 2014 - Ipsen announced that a first set of results
on phase III clinical study of Dysport® in the treatment of
adults suffering from Upper Limb Spasticity was presented on Saturday,
April 12th, at the 8th World Congress for
NeuroRehabilitation in Istanbul (Turkey). Four weeks after Dysport®
injection, the Phase III clinical study results demonstrated that:
-
Patients treated with Dysport® showed a statistically
significantly (p<0.0001) higher proportion of responders in muscle
tone improvement versus placebo (i.e. exhibiting =1 point
improvement as measured by the Modified Ashworth Scale, MAS). At
week 4, patients treated with Dysport® 500 units and
1000 units showed responding rates of 73.8% and 78.5%,
respectively, compared to 22.8% in the placebo arm;
-
Patients treated with Dysport® showed a statistically
significantly (p<0.0001) higher clinical benefit versus placebo,
as measured by the Physician Global Assessment (PGA). At week 4,
the mean PGA score for patients treated with Dysport®
500 units and 1000 units were 1.4 and 1.8, respectively, compared
to 0.6 in the placebo arm.
-
Additionally, patients treated with Dysport® showed a
higher proportion of responders from baseline in improved passive
function versus placebo (exhibiting =1 grade decrease as measured
by the disability assessment scale). At week 4, patients treated
with Dysport® 1000 units showed a statistically
significant response rate of 62%. Patients treated with Dysport®
500 units showed a clinically relevant response rate of 50%.
Placebo arm showed a 39% response rate.
6 Calculation taking into account the placement
aforementioned, the cancellation of the Ipsen shares purchased as part
of this transaction, and the cancellation of the 800 000 shares
purchased as part of the program announced on 6 November 2013
-
On 13 May 2014 - Ipsen announced that a supply of Increlex®
will be available in the U.S. starting 2 June 2014. In collaboration
with the FDA (Food and Drug Administration), Ipsen is releasing one
batch of Increlex®'s active ingredient. Ipsen anticipates
that additional lots will be released in the coming months, as the
company continues to work closely with the FDA to make additional
Increlex® lots available as soon as possible.
-
On 1 July 2014 - Ipsen announced that it has submitted a
Supplemental New Drug Application to the U.S. Food and Drug
Administration (FDA) for Somatuline® Depot®
120mg injection for the treatment of gastroenteropancreatic
neuroendocrine tumors (GEP-NETs). In the European Union, Ipsen has
submitted national marketing authorization variations for Somatuline®
Autogel® 120mg injection to the drug regulatory authorities
in 25 countries of the European Union. Following EU and US
submissions, Ipsen intends to implement worldwide submission roll-out.
-
On 11 July 2014 - Ipsen and Galderma, a global healthcare
company focused on dermatology and skin health, announced that they
have significantly expanded the scope of their neurotoxin partnership.
Under the terms of the agreement, the Dysport® distribution
rights in the US and Canada, held originally by Valeant, have been
included in the partnership between Ipsen and Galderma for the
distribution of Dysport®/Azzalure® in aesthetic
and dermatology indications. This partnership now covers the US,
Canada, Brazil and Europe7 for a period extending to 2036.
As part of this renegotiated agreement, Galderma will pay €25 million
to Ipsen and benefit from improved margins in those territories. Ipsen
will manufacture and supply the finished product to Galderma and
receive royalties from Galderma. In addition, the companies will
increase the scope of their R&D collaboration through which each
company will benefit from the other party's research compounds within
its respective and exclusive areas of focus. In this regard, Ipsen
will gain control of the intellectual property for Galderma's liquid
toxin in the US, Canada, Brazil and Europe1 in exchange for
a €10 million payment, while Galderma retains commercialization rights.
-
On 17 July 2014 - Ipsen announced that the New England Journal
of Medicine has published clinical trial results showing that
Somatuline® Autogel® / Somatuline®
Depot® (lanreotide) Injection 120 mg (referred to as
Somatuline®) achieved statistically significant
prolongation of progression free survival over placebo in patients
with metastatic gastroenteropancreatic neuroendocrine tumors
(GEP-NETs). CLARINET®, an investigational phase III
randomized, double-blind, placebo-controlled study of the
antiproliferative effects of Somatuline® was conducted in
48 centers across 14 countries. The article titled "Lanreotide in
Metastatic Enteropancreatic Neuroendocrine Tumors" is available online
at NEJM.org and has been published in the July 17th edition
(N. Engl. J. Med. 2014; 371: 224-233). The data gathered from 204
GEP-NET patients over the 96-week study showed that placebo-treated
patients had a median PFS of 18.0 months and 33.0% had not progressed
or died at 96 weeks, whereas the median PFS for Somatuline® treated
patients was not reached and 65.1% had not progressed or died at 96
weeks (stratified logrank test, p<0.001). This represented a 53%
reduction in risk of disease progression or death based on a hazard
ratio of 0.47 (95% CI: 0.30-0.73). These statistically and clinically
significant antiproliferative effects of Somatuline® were
observed in a large population of patients with grade G1 or G2 (World
Health Organization classification) GEP-NETs, and independent of
hepatic tumor volume (=25% or >25%). Quality of life measures were not
different between the Somatuline® and placebo groups.
Safety data generated from the study are consistent with the known
safety profile of Somatuline®.
-
On 26 August 2014 - The North-American affiliate announced that
a new supply of Increlex® would be available starting in
September 2014. In collaboration with the U.S. Food and Drug
Administration (FDA), Ipsen released a second batch of Increlex® in
2014. The first batch was made available for distribution in June of
2014.
1 Excluding Russia
-
On 1st September 2014 - Ipsen
announced that the U.S. Food and Drug Administration (FDA) had
accepted and granted priority review of its supplemental New Drug
Application (sNDA) for Somatuline® Depot® 120mg
injection in the treatment of gastroenteropancreatic neuroendocrine
tumors (GEP-NETs). The FDA designates priority review status to drug
candidates that have the potential to offer a significant improvement
in treatment compared to currently approved options. Decision is
expected in early Q1 2015. In the European Union, the dossier of the
national marketing authorization variations for Somatuline®
Autogel® 120mg injection has been validated by all national
25 drug regulatory authorities. The first decisions are expected by Q2
2015. The regulatory submissions and variations were supported by the
results of the CLARINET® Phase III study, which
demonstrated the antitumor effect of Somatuline® in the
treatment of patients with GEP-NETs, and which was recently published
in the July 17th issue of The New England Journal of
Medicine.
-
On 27 September 2014 - Ipsen announced the presentation at the
ESMO 2014 Congress (26-30 September in Madrid) of the preliminary
results of the phase II proof-of-concept clinical trial with
tasquinimod in monotherapy, evaluating the compound in four advanced
tumor types. The main objective of the study was to determine the
clinical activity of tasquinimod in advanced hepatocellular (HCC),
ovarian (OC), renal cell (RCC) and gastric (GC) carcinomas in patients
who had progressed after standard anti-tumor therapies. Primary
endpoint was the PFS rate at a predefined time for each cohort.
Secondary objectives included PFS, response rate, OS, safety,
pharmacokinetics and biomarkers.The data did not support further
development of tasquinimod in monotherapy in heavily pretreated
patients with advanced OC, RCC and GC. Pharmacokinetic and biomarkers
analyses are ongoing. Preliminary results from the futility analysis
reported sufficient clinical activity to complete the recruitment of
the HCC cohort for which results are expected in 2015.The safety
profile was consistent with the known safety profile of tasquinimod in
previous studies.
-
On 2nd October 2014 - Ipsen announced
that Susheel Surpal would step down as Chief Financial Officer of
Ipsen as of 31st October 2014 to pursue new opportunities.
-
On 10 October 2014 - Ipsen announced the appointment of Aymeric
Le Chatelier as Executive Vice President, Chief Financial Officer
effective as of 3 November 2014. He will report directly to Marc de
Garidel, Chairman and Chief Executive Officer and to Christel Bories,
Deputy Chief Executive Officer. He will be a member of the Chairman
Committee and of the Executive Committee.
-
On 10 October 2014 - Ipsen announced positive results from the
phase III study of triptorelin pamoate 11.25 mg (Decapeptyl®
3 months) administered subcutaneously in patients with locally
advanced or metastatic prostate cancer at the European Association of
Urology (EAU) 14th Central European Meeting in Cracow, Poland (10-12
October 2014). The primary objective of the study was to assess the
efficacy and safety profile of the sustained-release triptorelin
pamoate 11.25 mg (Decapeptyl® 3 months) formulation when
administered by the subcutaneous route in men with locally advanced or
metastatic prostate cancer. This objective was met with castration
levels of testosterone achieved in 97.6% [95% CI: 93.2-99.5] of men at
week 4 and castration maintained in 96.6% of these men [95% CI:
91.6-99.1] at week 26.
-
On 22 October 2014 - Ipsen and Lexicon Pharmaceuticals, Inc.
announced that they have entered into an exclusive licensing agreement
for Ipsen to commercialize telotristat etiprate outside of North
America and Japan, with a focus on the treatment of carcinoid
syndrome. Lexicon retains sole rights to commercialize telotristat
etiprate in the United States, Canada and Japan. Lexicon will continue
to lead the global Phase 3 clinical program for telotristat etiprate
in carcinoid syndrome, from which data are expected in 2015. The
pivotal Phase 3 trial is comparing telotristat etiprate to placebo on
a background of somatostatin analog (SSA) therapy, the current
standard of care, in patients whose carcinoid syndrome is not
adequately controlled with lanreotide or octreotide. The clinical
Phase 3 study is recruiting in approximately 70 centers worldwide.
Lexicon will continue to be responsible for the potential registration
of telotristat etiprate in the U.S., Canada and Japan, while Lexicon
and Ipsen will collaborate to seek regulatory approvals in Europe and
other countries within the Ipsen licensed territory, with Ipsen
assuming the lead responsibility in those markets. Under the financial
terms of the agreement, Lexicon is eligible to receive up to $145
million, comprising $23 million upfront payment and additional
payments contingent upon achievement of clinical, regulatory and
commercial milestones. In addition, Lexicon is also eligible to
receive royalties on net sales of telotristat etiprate in the licensed
territory.
-
On 6 November 2014 - Otonomy, Inc., a clinical-stage
biopharmaceutical company focused on the development and
commercialization of innovative therapeutics for diseases and
disorders of the inner and middle ear, and Ipsen, a global
specialty-driven pharmaceutical company, announced that they have
entered into an exclusive licensing agreement enabling Otonomy to
utilize Ipsen's gacyclidine data in the development and registration
of OTO-311. OTO-311 is Otonomy's sustained-exposure formulation of
gacyclidine, an N-MethylD-Aspartate (NMDA) receptor antagonist, in
development for the treatment of tinnitus.
-
On 18 November 2014 - Ipsen and the Salk Institute for
Biological Studies (Salk Institute) announced that they have agreed to
renew their collaboration in medical sciences for another three years.
The common objective for Ipsen and the Salk Institute is to achieve
critical insights in the understanding of human diseases so as to
develop new therapies for the treatment of patients afflicted with
serious medical conditions.
-
On 20 November 2014 - Ipsen and French National Center for
Scientific Research (CNRS) announced the creation of the Archi-Pex
(peptide architectures and formulations) joint research and innovation
lab in collaboration with the French Alternative Energies and Atomic
Energy Commission (CEA) and the University of Rennes 1. This is the
result of a public-private partnership active since 1999. The joint
Archi-Pex lab, supported by the French National Research Agency, seeks
to conduct multi-disciplinary research bringing together academic
teams in physics and biology with the researchers at Ipsen's center
for pharmaceutical development based in Dreux (France). The aim is to
innovate in the formulation of hormonal peptides and to reduce the
development time. Understanding of the pharmaceutical efficacy arising
from basic knowledge is the key to Archi-Pex project.
-
On 28 November 2014 - Ipsen announced that the U.S. Food and
Drug Administration (FDA) has accepted for review its supplemental
Biologics License Application (sBLA) for Dysport®
(abobotulinumtoxinA) in the treatment of upper limb spasticity in
adult patients. The regulatory filing was based on a clinical Phase
III study involving nearly 250 adult patients with upper limb
spasticity. The international, multi-center, double-blind, randomized,
placebo controlled trial compared the efficacy of Dysport®
versus placebo in hemiparetic patients following a stroke or brain
trauma. The data showed that those treated with Dysport®
demonstrated a statistically significant (p<0.0001) improvement in
muscle tone and a higher clinical benefit, versus placebo. The safety
profile observed in the study was consistent with the known safety
profile of Dysport®.
-
On 12 December 2014 - Ipsen announced that the International
Breast Cancer Study Group (IBCSG) presented results of the randomized
phase III SOFT clinical trial at the 2014 San Antonio Breast Cancer
Symposium. Suppression of Ovarian Function Trial (SOFT) assessed the
value of ovarian suppression in reducing breast cancer recurrence in
young women receiving tamoxifen, and evaluated the role of the
aromatase inhibitor exemestane plus ovarian suppression in this
population. Ovarian suppression was obtained entirely by monthly
injections of triptorelin (active ingredient of Ipsen's Decapeptyl®)
over 5 years for 81% of patients. Treatment combining tamoxifen plus
ovarian suppression reduced the relative risk of developing invasive
breast cancer recurrence by 22% in women who did not transition into
menopause after receiving chemotherapy, when compared to treatment
with tamoxifen alone.
-
On 16 December 2014 - François Garnier has been appointed
Executive Vice President, General Counsel for the Ipsen Group
effective as of January 5, 2015. As such, he will sit on the
Chairman's Committee and on the Executive Committee.
-
On 16 December 2014 - Ipsen announced that Somatuline®
Depot® (lanreotide) Injection 120 mg (referred to as
Somatuline®) was approved by the U.S. Food and Drug
Administration (FDA) for the treatment of adult patients with
unresectable, well- or moderately-differentiated, locally advanced or
metastatic gastroenteropancreatic neuroendocrine tumors
(GEP-NETs).Somatuline®'s approval was based on
demonstration of improved progression-free survival (PFS) in CLARINET®
multi-center, international, randomized (1:1), double-blind, placebo
controlled study that enrolled 204 patients with unresectable, well-
or moderately-differentiated, locally advanced or metastatic,
non-functioning GEP-NETs. Patients were randomized to receive either
Somatuline® (lanreotide) 120 mg or placebo subcutaneously
every 28 days. The primary efficacy endpoint was PFS as determined by
independent central radiology review. The trial demonstrated a
significant prolongation of PFS for the Somatuline®
(lanreotide) arm [HR 0.47 (95% CI: 0.30, 0.73); p < 0.001; stratified
log-rank test]. The median PFS in the Somatuline®
(lanreotide) arm had not been reached at the time of the final
analysis and therefore is greater than 22 months. The median PFS in
the placebo arm was 16.6 months. Safety data were evaluated in 101
patients who received at least one dose of Somatuline®
(lanreotide). The most commonly (greater than or equal to 10%)
reported adverse reactions in Somatuline®
(lanreotide)-treated patients were abdominal pain, musculoskeletal
pain, vomiting, headache, injection site reaction, hyperglycemia,
hypertension, and cholelithiasis. The most common serious adverse
reaction of Somatuline® (lanreotide) observed in this trial
was vomiting (4%).
After 31 December 2014, major developments included:
-
On 26 January 2015 - Ipsen announced topline results for two
double-blind phase III studies of Dysport®
(abobotulinumtoxinA) in Pediatric Lower Limb (PLL) spasticity in
children with cerebral palsy and in Adult Lower Limb (ALL) spasticity
in patients who had experienced a stroke or traumatic brain injury. In
the PLL phase III study, conducted in children with hemiparetic or
diplegic cerebral palsy, treatment with Dysport® showed a
statistically significant response versus placebo in the improvement
of muscle tone, as measured by the Modified Ashworth Scale (MAS;
primary endpoint), and a statistically significant overall benefit
versus placebo, as measured by the Physician Global Assessment (PGA;
first secondary endpoint). In the ALL phase III study, conducted in
hemiparetic patients who had experienced a stroke or traumatic brain
injury, treatment with Dysport® at the dose of 1500U showed
a statistically significant response versus placebo in the improvement
of muscle tone, as measured by the Modified Ashworth Scale (MAS;
primary endpoint). An overall benefit (measured by the Physician
Global Assessment (PGA); first secondary endpoint) versus placebo was
observed but did not reach statistical significance according to the
pre-specified statistical analysis. Other spasticity and functional
outcome results are currently being analyzed. The safety profile
observed in the studies was consistent with the known safety profile
of Dysport® in these indications. Comprehensive results
from these double-blind studies will be disclosed in the next few
months at major international congresses. Ipsen will share these
results with key regulatory agencies this year.
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 2014. In addition, certain measures
introduced in 2013 have continued to affect the Group's accounts
year-on-year.
Measures that have impacted 2014
In the Major Western European countries:
-
In France, the price of Smecta® was cut by 7.5% as of 1st
July 2014, following a first price cut of the same magnitude as of 1st
January 2014. Moreover, health authorities have required a 4.0% price
cut on Decapeptyl® as of 1st April 2014;
-
In the UK, Decapeptyl® has been sold at 100.0% of the NHS (National
Health Service) price since March 2014.
In the Other European countries:
-
In Belgium, Dysport® experienced a 2.4% price decrease as
of January 2015 as the product has been reimbursed for more than 15
years in the market. In Luxemburg, Dysport® will be
impacted by the same decrease as the country references the Belgium
price;
-
In Czech Republic, as of October 2014, the Ministry of Health decided
to increase drug prices to compensate for the Czech Kroun devaluation.
Ipsen benefited from a price increase of around 7.0% on all its
products;
-
In Denmark, in May 2014, the DHMA (The Danish Health and Medicines
Authority) granted a 50.0% price increase on Increlex®,
based on the Pharmacist Purchase Price;
-
In Estonia, the Ministry of Health decreased the price of Decapeptyl®
1M by 9.7% following application of international reference pricing.
However, the reimbursement rate increased to 100.0% from 50.0% for use
as adjuvant therapy to radiotherapy;
-
In Greece, the €2.44 billion claw-back introduced end of 2013 has not
been readjusted by the Ministry of Health as initially anticipated.
Health authorities are targeting €2 billion for 2014. Decapeptyl®
was impacted by a significant increase in patient co-payment. In
addition, since 1st April 2014, the Ministry of Health has
recognized the difference between biological products, biosimilars and
generics. It will therefore not be possible for these different
product types to be part of common tenders;
-
In Italy, Hexvix® experienced a 13.0% price cut in February
2014 after it became eligible for reimbursement at the national level;
-
In Lithuania, Somatuline® was granted national
reimbursement in April 2014 in the acromegaly indication;
-
In Poland, Decapeptyl® and Somatuline® have been
affected by a price revision applicable as of 1st January
2014. Dysport® obtained reimbursement in spasticity
indications, effective from July 2014 to July 2016. In Primary Care,
the price of Fortrans® increased by 10.0% in September 2014
following strong support from the Polish Endoscopy Medical Society;
-
In Portugal, the Ministry of Health is pressing the local
pharmaceutical association (APIFARMA) in the context of negotiations
with the industry on the spending exceeding a certain threshold in
2014. For the 2015 government budget, the Ministry of Finance
contemplates the introduction of an extraordinary tax with a
particular attention to pharmaceutical industry profits;
-
In the Netherlands, the application of international reference pricing
led to a price decrease on NutropinAq® and to price
increases on Somatuline®, Dysport® and Decapeptyl®
as of 1st April 2014. Somatuline® benefited from
a second price increase as of 1st October 2014;
-
In Norway, the December 2013 review of international reference pricing
led to price cuts on Dysport® and NutropinAq®,
and to a price increase on Somatuline®. In addition,
Somatuline® benefited from a price increase in November
2014 following the application of international reference pricing;
-
In Slovakia, in April 2014, Ipsen submitted prices for the second
yearly revision based on the average 3 lowest prices in EU 28. This
led to price decreases on all Ipsen products;
-
In Slovenia, the official price of Dysport® was cut in June
2014 to be aligned with the reimbursed price;
-
In Sweden, since January 2014, products that have been marketed for
more than 15 years (notably Decapeptyl®) are subject to a
mandatory price cut of 7.5%. In June 2014, TLV (The Dental and
Pharmaceutical Benefits Agency) granted a 25.0% price increase on
the Pharmacist Purchase Price to Increlex®;
-
In Switzerland, Dysport® was impacted by a price cut in
December 2013 following the application of international reference
price;
In the Rest of the World:
-
In Brazil, products with no generics on the market benefited from a
1.0% price increase in 2014;
-
In Colombia, the "National Committee of Drug Prices" (Comisión
Nacional de Precios de Medicamentos) imposed a price cut on 364
medicines in December 2013, including Dysport®. In August
2013, the prices of 195 medicines had already been regulated,
including Somatuline®;
-
In China, the NDRC (National Development & Reform Commission) issued a
"Low-Price Drug List" in May 2014 to align the prices of all ginkgo
biloba tablets. However, Tanakan® is excluded from this
list and will keep its original retail price;
-
In Turkey, due to a revision of international reference pricing in
September 2014, the price of Somatuline® was raised.
However, the mandatory rebate on the reimbursement price was also
raised.
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 2014.
Measures impacting beyond 2014
In the Major Western European countries:
-
In France, the 2014 Social Security Finance Bill (PLFSS) was
introduced, with the possibility for the first time for the pharmacist
to substitute biotechnology products by biosimilars, except when
forbidden by the physician on the prescription. This rule was not
enforced yet, pending the publication of a decree. In addition,
the French government presented the new Social Security Finance Bill
(PLFSS), which sets forth expenditure targets in the healthcare sector
for 2015. The target growth of healthcare expenditure has been fixed
at 2.1% year-on-year, down from 2.4% in 2014. This is expected to
result in €3.2 billion savings. In addition, Decapeptyl®
will experience a 3.0% price decrease as of 1st January
2015. Finally, the two Smecta® price cuts will fully impact
countries that reference French prices (incl. European Union,
sub-Saharan Africa) in 2015;
-
In Germany, the mandatory sales rebate for the official price of
prescription drugs, initially set at 16.0%, was reduced to 7.0% as of 1st
January 2014;
-
In Spain, the final Royal Decree List arising from the implementation
of the Reference Price System was published on 15 July 2014. As a
result, the official published prices of Decapeptyl® and
Dysport® will be affected. Additionally, the mandatory
rebate of 15.0% applicable on the official price of Decapeptyl®
was canceled;
-
In the UK, the new PPRS (Pharmaceutical Price Regulation Scheme)
was implemented, with the option for pharmaceutical companies to apply
a 5.0% to 7.0% price cut on the NHS (National Health Service)
selling price modulated over the whole portfolio, or the option to
reimburse this amount through pay back. Moreover, since January 2014,
tenders are managed at the regional level instead of the hospital
level.
In the Other European countries:
-
In Bulgaria, the Ministry of Health published a new ordinance to
extend the limitation of price increases of over-the-counter (OTC)
medicines to 1.0% for another year;
-
In Czech Republic, the Parliament approved the introduction of a
reduced VAT rate on medicines, down to 10.0% from 21.0% as of 2015.
The reduced VAT rate will have a positive impact on access to
medicines;
-
In Croatia, Czech Republic replaced France in the basket of countries
included in the international reference pricing system;
-
In Kazakhstan, pressurized to address corruption issues, the Ministry
of Healthcare and Social Development will amend the methodology and
mechanism for price determination, hence increasing transparency
within government procurement process. It intends to create a national
drug formulary that will include maximum pricing for medications with
proven clinical efficacy and for brands within the context of
international non-proprietary name (INN);
-
In Ukraine, the Ministry of Health published a draft resolution that
introduces Internal and External Reference Pricing for prescription
drugs and for medicines procured through state funds. Rule will be to
take the average price of the countries of origin: Bulgaria, the Czech
Republic, Hungary, Latvia, Moldova, Poland, Serbia, Slovakia. This
development reflects the intent of the Ukrainian government to monitor
drug prices, notably given the average price rise of 16.0% reported
this year, resulting from the "anti-crisis" measures (currency
devaluation and implementation of a 7.0% VAT on drug prices as of 1st
April 2014). The potential state price regulation would reportedly
affect 10,000 drugs, or approximately 80.0% of the market, with the
maximum margin on bulk purchases being 10.0%, and retail mark-up of
25.0%;
In the Rest of the World:
-
In Algeria, marketing authorisations for the Primary Care portfolio
were renewed. In addition, Smecta® "localization" has
successfully undergone review from the Algerian Price Committee. Ipsen
secured a price for the next 5 years and price revision will only
occur when a Smecta® generic is approved. In the context of
the sharp and continuous decline in oil prices, authorities are
looking at drastically reducing import costs, as of January 2015. This
will impact pharmaceuticals which account for €3 billion in the state
budget;
-
In South Africa, the Department of Health published draft legislation
governing pricing of novel drugs in the country. The guidelines set
forth a potential international reference pricing system. No timeline
for advancement is known yet;
-
In China, the NDRC (National Development & Reform Commission) will
deregulate the national drug pricing system from 2015. It will
theoretically allow the free setting of drug prices, rather than
forcing companies to adhere to government regulated price caps on drug
retail prices. However, local government tender centers will keep
control over the bidding price, which is the price to patients plus
the hospital margin;
-
In Morocco, the Ministry of Health is looking at lowering the prices
of several ranges of medications. This will affect drugs used for the
treatment of various chronic conditions, including cardiovascular
diseases, diabetes, inflammatory, infectious, digestive diseases, as
well as some cancer drugs and treatments for benign prostatic
hyperplasia;
-
In Tunisia, the creation of a National Medicines Agency ("Agence
nationale du Médicament") is at an advanced stage of preparation.
The Ministry of Health updated existing texts on regulatory and
clinical requirements so as to meet the highest international
standards;
-
In Turkey, authorities are thinking of introducing a flexible price
system in 2014. The exact content is not yet known but measures such
as not including countries under Troïka (countries where policies are
imposed by the European Commission, the European Central Bank and the
International Monetary Fund), an update of foreign exchange rates, and
a price increase for products under shortage, are currently under
consideration.
Comparison of consolidated sales for the four quarters and full years
2014 and 2013:
Sales by therapeutic area and by product
Note: Unless stated otherwise, all variations in sales are stated
excluding foreign exchange impacts and are computed by restating the
2013 sales with the 2014 exchange rates.
The following table shows sales by therapeutic area and by product for
the fourth quarters and full years 2014 and 2013:
|
|
4th quarter
|
|
12 months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
%
|
|
|
|
|
|
|
|
% Variation
|
|
|
|
|
|
|
|
%
|
|
Variation
|
|
|
|
|
|
%
|
|
at
|
|
(in million euros)
|
|
2014
|
|
2013
|
|
Variation
|
|
at
|
|
2014
|
|
2013
|
|
Variation
|
|
constant
|
|
|
|
|
|
|
|
|
|
constant
|
|
|
|
|
|
|
|
currency
|
|
|
|
|
|
|
|
|
|
currency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urology-oncology
|
|
77.1
|
|
79.5
|
|
-2.9%
|
|
-3.7%
|
|
332.7
|
|
313.0
|
|
6.3%
|
|
6.7%
|
|
of which Hexvix®
|
|
3.9
|
|
3.7
|
|
6.2%
|
|
6.0%
|
|
16.0
|
|
14.4
|
|
11.4%
|
|
11.1%
|
|
of which Decapeptyl®
|
|
73.2
|
|
75.8
|
|
-3.4%
|
|
-4.2%
|
|
316.6
|
|
298.6
|
|
6.0%
|
|
6.5%
|
|
Endocrinology
|
|
92.2
|
|
74.5
|
|
23.8%
|
|
21.7%
|
|
359.4
|
|
315.9
|
|
13.8%
|
|
14.0%
|
|
of which Somatuline®
|
|
73.9
|
|
60.3
|
|
22.5%
|
|
20.6%
|
|
287.5
|
|
246.9
|
|
16.4%
|
|
16.8%
|
|
of which NutropinAq®
|
|
13.9
|
|
14.0
|
|
-0.3%
|
|
-0.7%
|
|
59.0
|
|
56.3
|
|
4.9%
|
|
4.9%
|
|
of which Increlex®
|
|
4.4
|
|
0.2
|
|
2029.0%
|
|
865.8%
|
|
12.9
|
|
12.7
|
|
1.4%
|
|
1.3%
|
|
Neurology
|
|
59.4
|
|
55.9
|
|
6.4%
|
|
8.2%
|
|
255.0
|
|
242.2
|
|
5.3%
|
|
8.8%
|
|
of which Dysport®
|
|
59.2
|
|
55.9
|
|
5.9%
|
|
7.7%
|
|
254.5
|
|
242.2
|
|
5.1%
|
|
8.6%
|
|
Specialty care
|
|
228.8
|
|
209.9
|
|
9.0%
|
|
8.5%
|
|
947.1
|
|
871.1
|
|
8.7%
|
|
9.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastroenterology
|
|
52.6
|
|
51.6
|
|
1.8%
|
|
2.4%
|
|
219.3
|
|
219.9
|
|
-0.3%
|
|
2.2%
|
|
of which Smecta®
|
|
26.8
|
|
28.9
|
|
-7.3%
|
|
-7.3%
|
|
121.4
|
|
121.1
|
|
0.2%
|
|
2.7%
|
|
of which Forlax®
|
|
10.1
|
|
9.3
|
|
9.1%
|
|
9.1%
|
|
38.5
|
|
38.7
|
|
-0.7%
|
|
0.0%
|
|
Cognitive disorders
|
|
15.0
|
|
18.5
|
|
-18.7%
|
|
-9.7%
|
|
62.6
|
|
67.2
|
|
-6.8%
|
|
-0.6%
|
|
of which Tanakan®
|
|
15.0
|
|
18.5
|
|
-18.7%
|
|
-9.7%
|
|
62.6
|
|
67.2
|
|
-6.8%
|
|
-0.6%
|
|
Cardiovascular
|
|
3.6
|
|
3.9
|
|
-6.9%
|
|
-6.6%
|
|
18.7
|
|
20.6
|
|
-9.1%
|
|
-8.8%
|
|
of which Nisis® & Nisisco®
|
|
1.6
|
|
1.8
|
|
-12.1%
|
|
-12.1%
|
|
6.5
|
|
7.8
|
|
-15.9%
|
|
-15.9%
|
|
of which Ginkor®
|
|
1.7
|
|
1.6
|
|
1.0%
|
|
1.5%
|
|
11.2
|
|
11.7
|
|
-4.4%
|
|
-3.8%
|
|
Other Primary Care
|
|
3.0
|
|
3.6
|
|
-15.7%
|
|
-14.2%
|
|
11.3
|
|
12.5
|
|
-9.6%
|
|
-8.9%
|
|
of which Adrovance®
|
|
2.1
|
|
2.6
|
|
-16.4%
|
|
-16.4%
|
|
9.1
|
|
10.4
|
|
-12.6%
|
|
-12.6%
|
|
Primary care
|
|
74.2
|
|
77.5
|
|
-4.3%
|
|
-1.5%
|
|
311.9
|
|
320.2
|
|
-2.6%
|
|
0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Drug Sales
|
|
303.0
|
|
287.4
|
|
5.4%
|
|
5.9%
|
|
1259.0
|
|
1 191.3
|
|
5.7%
|
|
7.4%
|
|
Drug-related Sales*
|
|
4.1
|
|
5.6
|
|
-27.5%
|
|
-28.5%
|
|
15.9
|
|
33.5
|
|
-52.7%
|
|
-53.0%
|
|
Group Sales
|
|
307.1
|
|
293.0
|
|
4.8%
|
|
5.2%
|
|
1274.8
|
|
1 224.8
|
|
4.1%
|
|
5.7%
|
|
*Active ingredients and raw materials
In the fourth quarter 2014, sales of Specialty care products
reached €228.8 million, up 8.5% year-on-year. In 2014, sales amounted to
€947.1 million, up 9.9%. Sales in urology-oncology, endocrinology, and
neurology grew by respectively 6.7%, 14.0% and 8.8%. In 2014, the
relative weight of specialty care products continued to increase to
reach 74.3% of total Group sales, compared to 71.1% the previous year.
In Urology-oncology, sales of Decapeptyl®
reached €73.2 million in the fourth quarter 2014, down 4.2%
year-on-year, and €316.6 million for the full year 2014, up 6.5%. Sales
growth in 2014 benefited from a favorable comparison base weak product
performance in the first nine months 2013 in China and in the Middle
East, where Ipsen had limited the supply of its products due to the
absence of payment guarantees, but was penalized in the fourth quarter
2014 by the strong pick-up in sales in these regions in the fourth
quarter 2013. In 2014, Decapeptyl® performance nonetheless
took place in a contracting pharmaceutical market in Europe, notably
impacted by a more frequent use of co-payment in Southern Europe and a
slowdown in the growth of Eastern European countries. As such,
performance in France suffered from a decrease in volumes sold and from
the implementation of a 4.0% price cut as of 1st April 2014.
In 2014, sales of Hexvix® amounted to €16.0
million, up 11.1% compared to 2013, mainly generated in Germany. Over
the period, sales in Urology-oncology represented 26.1% of total Group
sales, compared to 25.6% the previous year.
In Endocrinology, sales reached €92.2 million in the fouth
quarter 2014, up 21.7% year-on-year. In 2014, sales amounted to €359.4
million, up 14.0%, and represented 28.2% of total Group sales, compared
to 25.8% the previous year.
Somatuline® - In the fourth quarter 2014, sales
reached €73.9 million, up 20.6% year-on-year. In 2014, sales of
Somatuline® grew 16.8% to €287.5 million, driven by strong
volume and value growth in the United States, strong volume growth in
Germany together with a reduction (from 16% to 7%) in mandatory rebates
on prescription drug sales, and solid volume momentum in the United
Kingdom. Somatuline® recorded good performance in Spain,
France, the Netherlands, Denmark and Belgium, and was penalized by a
price cut in Columbia.
NutropinAq® - In the fourth quarter 2014, sales
reached €13.9 million, down 0.7% compared to the same period in 2013. In
2014, sales of NutropinAq® amounted to €59.0 million, up 4.9%
year-on-year, driven by good performance in Germany and France.
Increlex® - In the fourth quarter 2014, sales
reached €4.4 million, up sharply compared to the same period in 2013,
helped by a favorable base effect arising from the shortage situation
that started mid-June 2013 in the United States and in August 2013 in
Europe. Supply gradually resumed in Europe in early 2014 and in the
United States in June 2014. In 2014, sales of Increlex®
amounted €12.9 million, up 1.3% year-on-year.
In Neurology, Dysport® sales reached
€59.2 million in the fourth quarter 2014, up 7.7% year-on-year. In 2014,
Dysport® sales amounted to €254.5 million, up 8.6%,
driven by the supply of the product to Galderma for aesthetic use and by
the solid volume performance of the therapeutic and aesthetic segments
in Brazil. Growth was affected by the intensification of competitive
intensity in South Korea and United Kingdom, while benefiting in Germany
from the reduction in mandatory rebates. Neurology sales represented
20.0% of total Group sales in 2014, compared to 19.8% a year earlier.
In the fourth quarter 2014, sales of Primary care products
reached €74.2 million, down 1.5% year-on-year. In 2014, sales amounted
to €311.9 million, up 0.5%. In France, sales of Primary care products
declined 9.9%, affected by two price cuts on Smecta® and the
launch of a competing product to Tanakan® in March 2013.
Internationally, sales increased 5.2%, driven by solid performance in
China, Algeria and Russia, offsetting the decline in France. Primary
care sales in France accounted for 27.8% of the Group's total primary
care sales, compared to 30.1% the previous year.
In Gastroenterology, sales reached €52.6 million in the fourth
quarter 2014, up 2.4% year-on-year. In 2014, sales amounted to €219.3
million euros, up 2.2% compared to 2013.
Smecta® - In the fourth quarter 2014, sales
reached €26.8 million, down 7.3% year-on-year, mainly affected by the
interruption of direct sales in Algeria, replaced from now on by the
sales of the active principle to a local manufacturer, which are
recorded in Drug-related sales. Restated for this item, sales increased
1.8% over the quarter. In 2014, sales amounted to €121.4 million euros,
up 2.7%, driven by solid growth in Russia, Algeria and China, but
affected in France by the two 7.5% price cuts implemented in January and
July 2014 and a low level of gastroenteritis epidemic compared to last
year. Smecta® sales represented 9.5% of total Group sales
over the period, compared to 9.9% the previous year.
Forlax® - In the fourth quarter 2014, sales
reached €10.1 million, up 9.1% year-on-year. In 2014, sales amounted to
€38.5 million euros, flat year-on-year, affected by the reinforcement of
the "Tiers-Payant1" regulation in France and by the lower
sales to our partners marketing generic versions of the product. In
2014, France represented 45.4% of total product sales, compared to 48.2%
the previous year.
In the cognitive disorders area, sales of Tanakan®
reached €15.0 million euros in the fourth quarter 2014, down 9.7%
year-on-year. In 2014, sales amounted to €62.6 million euros, down 0.6%,
driven by the good performance of the product in Russia. The product's
growth was penalized by the launch of a second "me-too" product in
France in 2013 and by a change in the commercial model for Spain, where
the product is now distributed by a partner. In 2014, 22.7% of Tanakan®
sales were achieved in France, compared to 24.3% the previous year.
In the cardiovascular area, sales reached €3.6 million euros in
the fourth quarter 2014, down 6.6% year-on-year. In 2014, sales amounted
to €18.7 million euros, down 8.8% over the period, mainly impacted by
the decline of Nisis® / Nisisco®
sales, which suffered from a 12.5% price cut in October 2013.
Sales of Other primary care products reached €3.0 million
in the fourth quarter 2014, down 14.2% year-on-year. In 2014, sales
amounted to €11.3 million, down 8.9%, mainly affected by the 12.6%
decline in Adrovance® sales.
In the fourth quarter 2014, drug-related sales (active ingredients
and raw materials) reached €4.1 million, down 28.5%
year-on-year. In 2014, sales amounted to €15.9 million euros, down
53.0%. Performance was notably explained by an unfavourable effect
associated with the change in methodology for the consolidation of sales
of the Swiss company Linnea. Indeed, sales of active ingredients and raw
materials made by Linnea, partner on which Ipsen and the Schwabe Group
exercise joint control, will from now on be consolidated under the
equity method of accounting2. Restated for this base effect,
sales declined 11.3%, affected by Ginkgo Biloba extracts and a decline
in diomagnite orders in Egypt and Korea, where local partners have
liquidity issues and margin erosion due to price cuts in the market.
1 With the "Tiers-Payant" regulation, the patient now pays
upfront for a branded drug and is reimbursed only later on
2 In accordance with the norm IFRS11 « Partnerships » that
came into force as of 1st January 2014 on the accounting
treatment of joint ventures
Sales by geographical area
Group sales by geographical area in the fourth quarters and and full
years 2014 and 2013:
|
|
4th quarter
|
|
12 months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
%
|
|
|
|
|
|
|
|
%
|
|
|
|
|
|
|
|
%
|
|
Variation
|
|
|
|
|
|
%
|
|
Variation
|
|
(in million euros)
|
|
2014
|
|
2013
|
|
Variation
|
|
at
|
|
2014
|
|
2013
|
|
Variation
|
|
at
|
|
|
|
|
|
|
|
|
|
constant
|
|
|
|
|
|
|
|
constant
|
|
|
|
|
|
|
|
|
|
currency
|
|
|
|
|
|
|
|
currency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
France
|
|
53.4
|
|
52.7
|
|
1.3%
|
|
1.3%
|
|
211.4
|
|
218.0
|
|
-3.0%
|
|
-3.0%
|
|
Germany
|
|
23.6
|
|
20.6
|
|
14.8%
|
|
14.8%
|
|
94.2
|
|
84.1
|
|
12.0%
|
|
12.0%
|
|
Italy
|
|
17.8
|
|
18.8
|
|
-5.4%
|
|
-5.4%
|
|
78.5
|
|
81.3
|
|
-3.4%
|
|
-3.4%
|
|
United Kingdom
|
|
17.8
|
|
15.4
|
|
15.6%
|
|
8.7%
|
|
65.1
|
|
57.3
|
|
13.5%
|
|
7.7%
|
|
Spain
|
|
15.6
|
|
14.0
|
|
11.4%
|
|
11.4%
|
|
59.9
|
|
56.6
|
|
5.8%
|
|
5.8%
|
|
Major Western European countries
|
|
128.2
|
|
121.5
|
|
5.5%
|
|
4.7%
|
|
509.1
|
|
497.3
|
|
2.4%
|
|
1.8%
|
|
Eastern Europe
|
|
43.0
|
|
49.2
|
|
-12.5%
|
|
2.3%
|
|
177.1
|
|
184.9
|
|
-4.2%
|
|
4.8%
|
|
Others Europe
|
|
36.8
|
|
34.4
|
|
7.1%
|
|
7.4%
|
|
147.0
|
|
144.5
|
|
1.7%
|
|
2.1%
|
|
Other European Countries
|
|
79.9
|
|
83.6
|
|
-4.4%
|
|
4.6%
|
|
324.1
|
|
329.4
|
|
-1.6%
|
|
3.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
21.2
|
|
14.2
|
|
49.4%
|
|
36.3%
|
|
79.2
|
|
64.2
|
|
23.2%
|
|
23.7%
|
|
Asia
|
|
46.0
|
|
41.8
|
|
10.1%
|
|
1.7%
|
|
190.5
|
|
177.3
|
|
7.4%
|
|
7.7%
|
|
Other countries in the Rest of the world
|
|
31.8
|
|
32.0
|
|
-0.6%
|
|
-1.5%
|
|
172.0
|
|
156.5
|
|
9.9%
|
|
13.6%
|
|
Rest of the World
|
|
77.8
|
|
73.8
|
|
5.4%
|
|
0.4%
|
|
362.5
|
|
333.9
|
|
8.6%
|
|
10.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group Sales
|
|
307.1
|
|
293.0
|
|
4.8%
|
|
5.2%
|
|
1274.8
|
|
1 224.8
|
|
4.1%
|
|
5.7%
|
|
Of which: Total Drug Sales
|
|
303.0
|
|
287.4
|
|
5.4%
|
|
5.9%
|
|
1259.0
|
|
1 191.3
|
|
5.7%
|
|
7.4%
|
|
Drug-related Sales*
|
|
4.1
|
|
5.6
|
|
-27.5%
|
|
-28.5%
|
|
15.9
|
|
33.5
|
|
-52.7%
|
|
-53.0%
|
|
* Active ingredients and raw materials
In the fourth quarter 2014, sales generated in the Major Western
European countries reached €128.2 million, up 4.7% year-on-year. In
2014, sales amounted to €509.1 million, up 1.8%. Sales in the Major
Western European countries represented 39.9% of total Group sales in
2014, compared to 40.6% the previous year.
France - In the fourth quarter 2014, sales reached €53.4 million,
up 1.3% year-on-year. In 2014, sales amounted to €211.4 million, down
3.0%, affected by the decline of primary care sales. Sales of Smecta®
decreased over the period, penalized by the low level of gastroenteritis
epidemic compared to last year and by two 7.5% price cuts implemented in
January and July 2014. Moreover, sales of Forlax® suffered
from generics competition while Tanakan® continued to be
impacted by the launch of a second "me-too" product in March 2013. Sales
of specialty care products, up 2.6% over the period, were driven by the
sustained growth of Somatuline® and NutropinAq®
sales, but penalized by the decrease in Decapeptyl® sales,
both in volume and value following the 4.0% price cut implemented as of 1st
April 2014. Consequently, the relative weight of France in the Group's
consolidated sales has continued to decrease and now represents 16.6% of
sales, compared to 17.8% the previous year.
Germany - In the fourth quarter 2014, sales reached €23.6
million, up 14.8% year-on-year. In 2014, sales reached €94.2 million, up
12.0%. The favorable impact associated with the reduction (from 16% to
7%) in mandatory rebates on prescription drug sales and the strong
volume growth of Somatuline® and Hexvix® offset
the reduction in the supply of Ginkgo Biloba extracts to our partner
Schwabe. Over the period, sales in Germany represented 7.4% of total
Group sales, compared to 6.9% a year earlier.
Italy - In the fourth quarter 2014, sales reached €17.8 million,
down 5.4% year-on-year. In 2014, sales reached €78.5 million, down 3.4%.
The growth of Somatuline® was not enough to offset the impact
of austerity control measures targeting hospital products. In 2014,
Italy represented 6.2% of consolidated Group sales, compared to 6.6% the
previous year.
United Kingdom - In the fourth quarter 2014, sales reached €17.8
million, up 8.7% year-on-year. In 2014, sales amounted to €65.1 million,
up 7.7%, fueled by the strong volume growth of Somatuline®
and Decapeptyl®, but affected by the decline in Dysport®
sales. In 2014, the United Kingdom represented 5.1% of total Group
sales, compared to 4.7% the previous year.
Spain - In the fourth quarter 2014, sales reached €15.6 million,
up 11.4% year-on-year. In 2014, sales amounted to €59.9 million, up
5.8%, driven by double-digit growth of Somatuline® sales but
affected by a change in the commercial model for Tanakan®,
for which revenues are no longer recorded in the sales line. In 2014,
Spain accounted for 4.7% of total Group sales, compared to 4.6% the
previous year.
In the fourth quarter 2014, sales generated in the Other European
countries reached €79.9 million, up 4.6% year-on-year, affected by
lower sales in Russia, where current geopolitical context is tense. In
2014, sales amounted to €324.1 million, up 3.6%, affected by an
unfavorable effect arising from the change in methodology for the
consolidation of sales of the Swiss company Linnea. Indeed, sales of
active ingredients and raw materials made by Linnea, partner on which
Ipsen and the Schwabe Group exercise joint control, will from now on be
consolidated under the equity method of accounting1. Restated
for this base effect, sales grew 9.1%, mainly driven by the good
performance of Tanakan® in Russia, following a media campaign
and the implementation of a new distribution scheme as of 1st
April 2014. Sales were also driven by the supply of Dysport®
for aesthetic use to Galderma, as well as the solid performance of the
Netherlands, Turkey, Denmark, and Belgium. Sales were impacted by the
consequences of the political crisis ongoing in Ukraine. In 2014, sales
in this region represented 25.4% of consolidated Group sales, compared
to 26.9% the previous year.
In the fourth quarter 2014, sales generated in North America
reached €21.2 million, up 36.3% year-on-year, driven by the resumption
of Increlex® supply in June 2014, and the strong 30.5% growth
of Somatuline®. In 2014, sales amounted to €79.2
million, up 23.7%, driven by the solid growth of Somatuline®
in both volume and value and the exceptional orders made by Galderma in
aesthetic medicine in the third quarter, but affected by the supply
interruption of Increlex® in the first half of the year.
Restated for the Increlex® supply interruption, sales
increased 31.6% in 2014. Sales in North America represented 6.2% of
consolidated Group sales, compared to 5.2% a year earlier.
In the fourth quarter 2014, sales generated in the Rest of the World
reached €77.8 million, up 0.4% year-on-year. In 2014, sales amounted to
€362.5 million, up 10.4%, boosted by a favourable base effect in the
Middle East, where Ipsen had stopped supplying its products in certain
countries of the region in 2013 due to the absence of payment
guarantees. Sales growth in the Rest of the World mainly arose from
strong volume growth in China and Algeria (notably of Decapeptyl® and
Smecta®), and in Brazil, where Dysport® recorded
good performance in aesthetic and therapeutic medicines. In 2014, sales
in the Rest of the World have continued their progression to reach 28.4%
of total consolidated Group sales, compared to 27.3% the previous year.
1 In accordance with the norm IFRS11 « Partnerships »
applicable since 1st January 2014 on the accounting treatment
of joint ventures
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