[January 28, 2014] |
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Ipsen: sales in the fourth quarter and full year 2013
PARIS --(Business Wire)--
Regulatory News:
Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) today reported its sales
for the fourth quarter and the full year 2013.
Consolidated sales IFRS (unaudited)
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4th Quarter
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12 Months
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(in million euros)
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2013
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2012
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% Variation
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% Variation at constant currency
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2013
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2012
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% Variation
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% Variation at constant currency
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SALES BY REGION
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Major Western European countries
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121.5
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125.2
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(3.0%)
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(2.6%)
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497.3
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518.5
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(4.1%)
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(3.6%)
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Other European countries
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83.6
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76.7
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9.0%
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12.3%
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329.4
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306.0
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7.6%
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9.5%
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North America
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14.2
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18.2
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(22.0%)
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(18.0%)
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64.2
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72.8
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(11.7%)
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(8.7%)
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Rest of the world
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73.8
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74.7
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(1.2%)
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4.2%
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333.9
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322.2
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3.6%
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7.1%
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Group Sales
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293.0
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294.9
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(0.6%)
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2.0%
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1,224.8
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1,219.5
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0.4%
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2.2%
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SALES BY THERAPEUTIC AREA
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Specialty care
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209.9
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210.3
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(0.2%)
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2.6%
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871.1
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862.5
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1.0%
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3.0%
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Primary care
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77.5
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78.0
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(0.5%)
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2.0%
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320.2
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324.6
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(1.4%)
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(0.1%)
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Total Drug Sales
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287.4
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288.2
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(0.3%)
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2.4%
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1,191.3
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1,187.0
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0.4%
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2.1%
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Drug-related sales *
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5.6
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6.6
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(15.2%)
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(14.3%)
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33.5
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32.5
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3.1%
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4.2%
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Group Sales
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293.0
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294.9
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(0.6%)
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2.0%
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1,224.8
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1,219.5
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0.4%
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2.2%
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* Active substances and raw materials
Commenting on the full year 2013 sales performance, Marc de Garidel,
Chairman and Chief Executive Officer of Ipsen, said: "In 2013,
Specialty care sales were up 3.0%1, driven by
the performance of our two growth drivers, Somatuline®
and Dysport®, respectively up 11.1%1
and 7.0%1. Moreover, Primary care beat
expectations, driven by strong international performance and a slowdown
of the decline in France." Marc de Garidel added: "2013
was marked by key clinical results for the Group with the CLARINET®
study and the Dysport® study in spasticity (AUL2).
Additionally, Ipsen confirms its US commitment with the decision to
launch Somatuline® alone in the GEP NET3
indication."
Highlights of the fourth quarter and full year
2013 sales
Note: Unless stated otherwise, all variations in sales are stated
excluding foreign exchange4 impacts.
In the fourth quarter 2013, Group drug sales were up 2.4%, driven
by both specialty care, up 2.6% year-on-year, and primary care, up 2.0%
year-on-year.
In the fourth quarter 2013, Consolidated Group sales reached
€293.0 million, up 2.0% year-on-year.
In the fourth quarter 2013, sales generated in the Major Western
European countries amounted to €121.5 million, down 2.6%
year-on-year.
In the fourth quarter 2013, sales generated in North America
reached €14.2 million, down 18.0% year-on-year, mainly impacted by the
Increlex® supply interruption that occurred in mid-June.
In the fourth quarter 2013, sales generated in the Other European
countries reached €83.6 million, up 12.3% year-on-year.
In the fourth quarter 2013, sales generated in the Rest of the World
reached €73.8 million, up 4.2% year-on-year.
In 2013, Group drug sales grew 2.1% or 0.4% at current exchange rate.
Consolidated Group sales reached €1,224.8 million in 2013, up
2.2% year-on-year.
In 2013, sales generated in the major Western European countries
amounted to €497.3 million euros, down 3.6% 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, compared to 42.5% the previous year.
In 2013, sales generated in the Other European countries reached
€329.4 million, up 9.5% year-on-year, 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. 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. Sales in this region represented 26.9% of
consolidated Group sales, compared to 25.1% a year earlier.
In 2013, sales generated in North America reached €64.2 million,
down 8.7%, mainly impacted by the Increlex® supply
interruption that occurred in mid-June. Restated for the Increlex®
supply interruption, sales were up 6.3% 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. Sales in North America represented 5.2% of
consolidated Group sales, compared to 6.0% a year earlier.
In 2013, sales generated in the Rest of the World amounted to
€333.9 million, up 7.1%. 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.
In 2013, sales of Specialty Care products reached 871.1 million,
up 3.0% year-on-year or 1.0% at current exchange rate. Sales in
Neurology and in Endocrinology grew by respectively 7.0% and 4.3%, while
sales in Uro-oncology declined 1.2% year-on-year. In 2013, the relative
weight of specialty care products continued to increase to reach 71.1%
of total Group sales, compared to 70.7% the previous year.
In 2013, sales of Primary Care products amounted to €320.2
million, slightly down 0.1% year-on-year. The strong performance of
China, Russia and Algeria, in particular, offset the consequences in
France of the launch of a competitive product to Tanakan® in
March 2013 and of the implementation of the regulation known as
"Tiers-Payant5" in the summer 2012. Primary care sales
represented 26.1% of Group consolidated sales in 2013, compared to 26.6%
the previous year. Primary care sales in France accounted for 30.1% of
the Group's total primary care sales, compared to 38.1% the previous
year.
1 Year-on-year growth excluding foreign exchange impacts (see
appendix) 2 Adult Upper Limb (membres supérieurs chez
l'adulte) 3 Gastro-entero-pancreatic neuroendocrine
tumours 4 See appendix 5 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 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
2012, R&D expenditure totalled close to €250 million, representing more
than 20% of Group sales. The Group has close to 4,900 employees
worldwide. Ipsen's shares are traded on segment A of Euronext Paris
(stock code: IPN, ISIN code: FR0010259150) and eligible to the "Service
de Règlement Différé" ("SRD"). The Group is part of the SBF 120 index.
Ipsen has implemented a Sponsored Level I American Depositary Receipt
(ADR) program, which trade on the over-the-counter market in the United
States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein
are based on the Group's management strategy, current views and
assumptions. Such statements involve known and unknown risks and
uncertainties that may cause actual results, performance or events to
differ materially from those anticipated herein. All of the above risks
could affect the Group's future ability to achieve its financial
targets, which were set assuming reasonable macroeconomic conditions
based on the information available today. 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
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. 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
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 2012 figures
with the 2013 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 2012
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.
-
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.
-
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), 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. Resupply in the US is still pending. Lonza is
working closely with the Food and Drug Administration (FDA) to address
these issues.
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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. 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.
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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 in 2013
During 2013, major developments included:
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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). Lonza has been working closely with the Food and Drug
Administration (FDA) to address these issues. Ipsen has been
diligently addressing management of the shortage period to reduce its
impact on the patients and their families. The supply interruption
occurred in mid-June 2013 in the US and in Q3 2013 in Europe and the
rest of the world. Re-supply before the end of 2013 is not currently
anticipated.
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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.
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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. The costs arising from this reorganization are not
expected to be material for the Group.
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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 €28 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 will not impact 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 euros from Ipsen.
-
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 are now in
process to allow 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 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 million dollars1. 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 euros to 40
million euros. 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.
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
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
€2.44 billion. The government is aiming at €2 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 sales for the fourth quarters and full
year of 2013 and 2012:
Note: Unless otherwise stated, all variations in sales are expressed
excluding foreign exchange.
Sales by geographical area
Group sales by geographical area in the fourth quarters and full years
2013 and 2012 were as follows:
|
|
4th Quarter
|
|
|
|
12 Months
|
|
|
|
|
|
|
|
(in million euros)
|
|
2013
|
|
2012
|
|
% Change
|
|
% Change at constant currency
|
|
|
|
2013
|
|
2012
|
|
% Change
|
|
% Change at constant currency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
France
|
|
52.7
|
|
58.7
|
|
(10.2%)
|
|
(10.2%)
|
|
|
|
218.0
|
|
246.3
|
|
(11.5%)
|
|
(11.5%)
|
United Kingdom
|
|
15.4
|
|
14.7
|
|
5.2%
|
|
9.4%
|
|
|
|
57.3
|
|
56.6
|
|
1.3%
|
|
6.1%
|
Spain
|
|
14.0
|
|
14.0
|
|
(0.2%)
|
|
(0.2%)
|
|
|
|
56.6
|
|
56.8
|
|
(0.4%)
|
|
(0.4%)
|
Germany
|
|
20.6
|
|
19.6
|
|
5.2%
|
|
5.3%
|
|
|
|
84.1
|
|
77.0
|
|
9.1%
|
|
9.1%
|
Italy
|
|
18.8
|
|
18.3
|
|
2.4%
|
|
2.4%
|
|
|
|
81.3
|
|
81.7
|
|
(0.6%)
|
|
(0.6%)
|
Major Western European countries
|
|
121.5
|
|
125.2
|
|
(3.0%)
|
|
(2.6%)
|
|
|
|
497.3
|
|
518.5
|
|
(4.1%)
|
|
(3.6%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eastern Europe
|
|
49.2
|
|
43.6
|
|
12.8%
|
|
18.3%
|
|
|
|
184.9
|
|
169.1
|
|
9.3%
|
|
12.5%
|
Others Europe
|
|
34.4
|
|
33.1
|
|
3.9%
|
|
4.7%
|
|
|
|
144.5
|
|
136.9
|
|
5.5%
|
|
5.9%
|
Other European Countries
|
|
83.6
|
|
76.7
|
|
9.0%
|
|
12.3%
|
|
|
|
329.4
|
|
306.0
|
|
7.6%
|
|
9.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
14.2
|
|
18.2
|
|
(22.0%)
|
|
(18.0%)
|
|
|
|
64.2
|
|
72.8
|
|
(11.7%)
|
|
(8.7%)
|
Asia
|
|
41.8
|
|
43.2
|
|
(3.2%)
|
|
0.1%
|
|
|
|
177.3
|
|
167.3
|
|
6.0%
|
|
7.4%
|
Other countries in the Rest of the world
|
|
32.0
|
|
31.6
|
|
1.5%
|
|
10.2%
|
|
|
|
156.5
|
|
154.8
|
|
1.1%
|
|
6.8%
|
Rest of the World
|
|
73.8
|
|
74.7
|
|
(1.2%)
|
|
4.2%
|
|
|
|
333.9
|
|
322.2
|
|
3.6%
|
|
7.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group Sales
|
|
293.0
|
|
294.9
|
|
(0.6%)
|
|
2.0%
|
|
|
|
1,224.8
|
|
1,219.5
|
|
0.4%
|
|
2.2%
|
Of which: Total Drug Sales
|
|
287.4
|
|
288.2
|
|
(0.3%)
|
|
2.4%
|
|
|
|
1,191.3
|
|
1,187.0
|
|
0.4%
|
|
2.1%
|
Drug-related Sales*
|
|
5.6
|
|
6.6
|
|
(15.2%)
|
|
(14.3%)
|
|
|
|
33.5
|
|
32.5
|
|
3.1%
|
|
4.2%
|
* Active ingredients and raw materials
In the fourth quarter 2013, sales generated in the Major Western
European countries amounted to €121.5 million, down 2.6%
year-on-year. In 2013, sales generated in the major Western European
countries amounted to €497.3 million euros, down 3.6% 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.
France - In the fourth quarter 2013, sales reached €52.7 million,
down 10.2% year-on-year. In 2013, sales reached €218.0 million, down
11.5% year-on-year, affected by the continuous decline of primary care
sales, despite the strong resilience of Smecta® sales, stable
year-on-year. Moreover, sales of Tanakan® were impacted by
the delisting of the product since March 2012 and by the launch of a
competitive product in March 2013. Finally, since July 2012, sales of
the Group's genericized drugs (Nisis®/Nisisco® and
Forlax®) were negatively impacted by the step-up of the
regulation known as "Tiers-Payant1". In specialty care, sales
were slightly down in 2013, despite the strong volume growth of
Somatuline® and NutropinAq®. Sales of
specialty care products were mainly impacted by the decline in Decapeptyl®
sales, notably arising from the collateral effects of the sales
force restructuring. Consequently, the relative weight of France in the
Group's consolidated sales has continued to decrease and now represents
17.8% of total Group sales, compared to 20.2% the previous year.
United Kingdom - In the fourth quarter 2013, sales reached €15.4
million, up 9.4% year-on-year. In 2013, sales reached €57.3 million, up
6.1%, notably fuelled by the strong volume growth of Decapeptyl®
and the sustained growth of Somatuline®. Over the period, the
United Kingdom represented 4.7% of total Group sales, in line with the
previous year.
Spain - In the fourth quarter 2013, sales reached €14.0 million,
slightly down 0.2% year-on-year. In 2013, sales reached €56.6 million,
slightly down 0.4% year-on-year in a significantly contracting Spanish
pharmaceutical market. Moreover, the delisting of Tanakan®
since September 2012 negatively impacted the product's sales. In a
difficult context, Somatuline® nonetheless posted sustained
volume growth. In 2013, sales in Spain represented 4.6% of total Group
sales, a ratio in line with the previous year.
Germany - In the fourth quarter 2013, sales reached €20.6
million, up 5.3% year-on-year. In 2013, sales reached €84.1 million, up
9.1% year-on-year, driven by strong volume growth of Somatuline®,
NutropinAq® and Hexvix® of respectively 32.8%,
18.3% and 14.2%. Moreover, revenues benefited from the settlement of
litigation relative to the marketing rights of a Decapeptyl®
generic in the country. Restated for this item, sales were up 7.2%. In
2013, sales in Germany represented 6.9% of total Group sales, compared
to 6.3% a year earlier.
Italy - In the fourth quarter 2013, sales reached €18.8 million,
up 2.4% year-on-year. In 2013, sales reached €81.3 million, slightly
down 0.6% year-on-year. The deterioration of the economic environment
affected the budget of regional health funds, which have consequently
implemented austerity policies, mainly targeting hospital products.
Italy represented 6.6% of 2013 consolidated Group sales, a stable ratio
year-on-year.
In the fourth quarter 2013, sales generated in the Other European
countries reached €83.6 million, up 12.3% year-on-year. In 2013,
sales amounted to €329.4 million, up 9.5%. 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.
In the fourth quarter 2013, sales generated in North America
reached €14.2 million, down 18.0% year-on-year, mainly impacted by the
Increlex® supply interruption that occurred in mid-June. In
2013, sales reached €64.2 million, down 8.7%. Restated for the Increlex®
supply interruption, sales were up 6.3% 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.
In the fourth quarter, sales generated in the Rest of the World
reached €73.8 million, up 4.2% year-on-year. In 2013, sales amounted to
€333.9 million, up 7.1%. 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 the partnership
with Sanofi 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.
1 With the "Tiers-Payant" regulation, the patient now pays
upfront for a branded drug and is reimbursed only later on
Sales by therapeutic area and by product
The following table shows sales by therapeutic area and by product for
the fourth quarters and full year of 2013 and 2012:
|
|
4th Quarter
|
|
|
|
12 Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in million euros)
|
|
2013
|
|
2012
|
|
% Change
|
|
% Change at constant currency
|
|
|
|
2013
|
|
2012
|
|
% Change
|
|
% Change at constant currency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uro-oncology
|
|
79.5
|
|
77.9
|
|
2.0%
|
|
3.3%
|
|
|
|
313.0
|
|
318.7
|
|
(1.8%)
|
|
(1.2%)
|
of which Hexvix®
|
|
3.7
|
|
3.3
|
|
10.2%
|
|
10.2%
|
|
|
|
14.4
|
|
12.3
|
|
16.7%
|
|
16.7%
|
of which Decapeptyl®
|
|
75.8
|
|
74.5
|
|
1.7%
|
|
3.0%
|
|
|
|
298.6
|
|
306.4
|
|
(2.5%)
|
|
(1.9%)
|
Endocrinology
|
|
74.5
|
|
77.7
|
|
(4.0%)
|
|
(1.8%)
|
|
|
|
315.9
|
|
307.6
|
|
2.7%
|
|
4.3%
|
of which Somatuline®
|
|
60.3
|
|
57.3
|
|
5.4%
|
|
8.0%
|
|
|
|
246.9
|
|
225.7
|
|
9.4%
|
|
11.1%
|
of which NutropinAq®
|
|
14.0
|
|
13.9
|
|
0.7%
|
|
1.6%
|
|
|
|
56.3
|
|
53.6
|
|
5.0%
|
|
5.7%
|
of which Increlex®
|
|
0.2
|
|
6.5
|
|
(96.8%)
|
|
(96.7%)
|
|
|
|
12.7
|
|
28.3
|
|
(55.1%)
|
|
(53.9%)
|
Neurology
|
|
55.9
|
|
54.7
|
|
2.1%
|
|
7.9%
|
|
|
|
242.2
|
|
236.2**
|
|
2.5%
|
|
7.0%
|
of which Dysport®
|
|
55.9
|
|
54.7
|
|
2.1%
|
|
7.9%
|
|
|
|
242.2
|
|
236.1
|
|
2.6%
|
|
7.0%
|
Specialty Care
|
|
209.9
|
|
210.3
|
|
(0.2%)
|
|
2.6%
|
|
|
|
871.1
|
|
862.5
|
|
1.0%
|
|
3.0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastroenterology
|
|
51.6
|
|
52.7
|
|
(2.1%)
|
|
(0.3%)
|
|
|
|
219.9
|
|
199.9
|
|
10.0%
|
|
11.3%
|
of which Smecta®
|
|
28.9
|
|
30.0
|
|
(3.6%)
|
|
(1.1%)
|
|
|
|
121.1
|
|
113.5
|
|
6.8%
|
|
8.1%
|
of which Forlax®
|
|
9.3
|
|
9.3
|
|
(0.7%)
|
|
0.0%
|
|
|
|
38.7
|
|
38.7
|
|
0.0%
|
|
0.3%
|
Cognitive disorders
|
|
18.5
|
|
17.2
|
|
7.3%
|
|
11.2%
|
|
|
|
67.2
|
|
79.0
|
|
(15.0%)
|
|
(13.3%)
|
of which Tanakan®
|
|
18.5
|
|
17.2
|
|
7.3%
|
|
11.2%
|
|
|
|
67.2
|
|
79.0
|
|
(15.0%)
|
|
(13.3%)
|
Cardiovascular
|
|
3.9
|
|
4.2
|
|
(8.4%)
|
|
(8.2%)
|
|
|
|
20.6
|
|
32.4
|
|
(36.5%)
|
|
(36.4%)
|
of which Nisis® & Nisisco®
|
|
1.8
|
|
1.5
|
|
20.0%
|
|
20.0%
|
|
|
|
7.8
|
|
18.2
|
|
(57.2%)
|
|
(57.2%)
|
of which Ginkor®
|
|
1.6
|
|
2.3
|
|
(28.5%)
|
|
(28.1%)
|
|
|
|
11.7
|
|
11.9
|
|
(1.4%)
|
|
(1.1%)
|
Other Primary Care
|
|
3.6
|
|
3.8
|
|
(5.6%)
|
|
(5.6%)
|
|
|
|
12.5
|
|
13.2
|
|
(5.0%)
|
|
(5.0%)
|
of which Adrovance®
|
|
2.6
|
|
2.9
|
|
(11.4%)
|
|
(11.4%)
|
|
|
|
10.4
|
|
11.5
|
|
(9.6%)
|
|
(9.6%)
|
Primary Care
|
|
77.5
|
|
78.0
|
|
(0.5%)
|
|
2.0%
|
|
|
|
320.2
|
|
324.6
|
|
(1.4%)
|
|
(0.1%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Drug Sales
|
|
287.4
|
|
288.2
|
|
(0.3%)
|
|
2.4%
|
|
|
|
1,191.3
|
|
1,187.0
|
|
0.4%
|
|
2.1%
|
Drug-related Sales*
|
|
5.6
|
|
6.6
|
|
(15.2%)
|
|
(14.3%)
|
|
|
|
33.5
|
|
32.5
|
|
3.1%
|
|
4.2%
|
Group Sales
|
|
293.0
|
|
294.9
|
|
(0.6%)
|
|
2.0%
|
|
|
|
1,224.8
|
|
1,219.5
|
|
0.4%
|
|
2.2%
|
*Active ingredients and raw materials ** The 0.1 million euros
difference with Dysport® sales arose from a final payment
received on Apokyn®, whose North American development and
marketing rights were sold to Britannia Pharmaceuticals in November 2011
In the fourth quarter 2013, sales of Specialty Care products
reached €209.9 million, up 2.6% year-on-year. In 2013, sales reached
871.1 million, up 3.0% year-on-year or 1.0% at current exchange rate.
Sales in Neurology and in Endocrinology grew by respectively 7.0% and
4.3%, while sales in Uro-oncology declined 1.2% year-on-year. In 2013,
the relative weight of specialty care products continued to increase to
reach 71.1% of total Group sales, compared to 70.7% the previous year.
In Uro-oncology, sales of Decapeptyl®
reached €75.8 million in the fourth quarter 2013, up 3.0% year-on-year.
In 2013, sales reached €298.6 million, down 1.9%. Restated for the
situation in the Middle East, which occured in the second quarter, sales
were down 1.4% in 2013. This decrease took place in a strained
environment in Europe, negatively impacted by a more frequent use of
co-payment, a contracting pharmaceutical market in Southern Europe and a
slowdown in the growth of Eastern European countries. In France, beyond
the decline of the LhRH market, Decapeptyl® sales were
affected by the consequences of the primary care sales force
restructuring. Finally, sales were impacted by the toughening of the
competitive environment in China with the launch of new local
competitors and the disruption of hospital market promotion due to the
investigation of certain pharmaceutical companies by local authorities.
In 2013, sales of Hexvix® amounted to €14.4
million, mostly generated in Germany. Over the period, sales in
Uro-oncology represented 25.6% of total Group sales, compared to 26.1%
the previous year.
In Endocrinology, sales amounted to €74.5 million in the fourth
quarter 2013, down 1.8% year-on-year. For the year, sales reached €315.9
million, up 4.3%, affected by the Increlex® shortage
outstanding since mid-June in the United States and since August in
Europe. Restated for Increlex® sales, revenues were up 10.1%.
Endocrinology sales represented 25.8% of total Group sales in 2013,
compared to 25.2% the previous year.
Somatuline® - In the fourth quarter 2013, sales
reached €60.3 million, up 8.0% year-on-year. In 2013, Somatuline®
sales reached €246.9 million, up 11.1% year-on-year, driven by strong
growth in the United States, where Somatuline® now boasts
around 50% market share1 in acromegaly, in Germany, France,
the UK, the Netherlands, Spain, Poland, Mexico and Australia.
NutropinAq® - In the fourth quarter 2013, sales
reached €14.0 million, up 1.6% year-on-year. In 2013, sales of NutropinAq®
reached €56.3 million, up 5.7%, driven by solid performance in Germany,
France, the Netherlands, and Kazakhstan.
Increlex® - In the fourth quarter 2013, sales
reached €0.2 million, down 96.7% year-on-year. In 2013, Increlex®
sales reached €12.7 million, down 53.9% year-on-year. Sales were
impacted by the shortage situation outstanding since mid-June in the
United States and since August in Europe. On December 18th
2013, Ipsen announced that the Group was preparing for the resupply of
Increlex® in the European Union.
In Neurology, Dysport® sales reached
€55.9 million in the fourth quarter 2013, up 7.9% year-on-year. In 2013,
sales reached €242.2 million, up 7.0% year-on-year, impacted by the the
Middle East situation that took place in the second quarter 2013.
Restated for this item, Dysport® sales were up 7.6%, driven
by strong sales growth in Russia and Brazil and the continuous provision
of Dysport® for aesthetic use to Galderma and to Valeant.
Neurology sales represented 19.8% of total Group sales in 2013, compared
to 19.4% a year earlier.
In the fourth quarter 2013, sales of Primary Care products
amounted to €77.5 million, up 2.0% year-on-year. In 2013, sales amounted
to €320.2 million, slightly down 0.1% year-on-year. The strong
performance of China, Russia and Algeria, in particular, offset the
consequences in France of the launch of a competitive product to Tanakan®
in March 2013 and of the implementation of the regulation known as
"Tiers-Payant2" in the summer 2012. Primary care sales
represented 26.1% of Group consolidated sales in 2013, compared to 26.6%
the previous year. Primary care sales in France accounted for 30.1% of
the Group's total primary care sales, compared to 38.1% the previous
year.
In Gastroenterology, sales reached €51.6 million in the fourth
quarter 2013, up 0.3% year-on-year. In 2013, sales amounted to €219.9
million, up 11.3% year-on-year.
Smecta® - In the fourth quarter 2013, sales
reached €28.9 million, down 1.1% year-on-year. Smecta® sales
for the year amounted to €121.1 million, up 8.1% year-on-year, mainly
driven by strong performance in China, Russia and Algeria. Smecta®
sales represented 9.9% of total Group sales over the period, compared to
9.3% the previous year.
Forlax® - In the fourth quarter 2013, sales
reached €9.3 million, in line with the previous year. In 2013, sales
reached 38.7 million euros, slightly up 0.3%, despite the reinforcement
of the "Tiers-Payant1" regulation in France in July 2012.
Over the period, France represented 48.2% of total product sales,
compared to 57.1% the previous year.
In the cognitive disorders area, sales of Tanakan®
in the fourth quarter 2013 reached €18.5 million euros, up 11.2%
year-on-year. In 2013, sales amounted to €67.2 million, down 13.3%,
affected by the delisting of the product in France in March 2012, in
Romania in May 2012 and in Spain in September 2012. Sales were also
impacted by the launch of a competitive product in France in March 2013.
Over the period, 24.3% of Tanakan® sales were achieved in
France, compared to 32.9% the previous year.
In the cardiovascular area, sales amounted to €3.9 million euros
in the fourth quarter 2013, down 8.2% year-on-year. In 2013, sales
amounted to €20.6 million, down 36.4% year-on-year, mainly impacted by
the decline of Nisis® / Nisisco®
sales, notably arising from the reinforcement of the "Tiers-payant2"
regulation in July 2012.
Sales of Other primary care products reached €3.6 million in the
fourth quarter 2013, down 5.6%. In 2013, sales reached €12.5 million,
down 5.0% year-on-year, mainly impacted by the 9.6% decrease in Adrovance®
sales.
In the fourth quarter 2013, drug-related sales (active ingredients
and raw materials) reached €5.6 million, down 14.3%. In 2013,
sales amounted to €33.5 million, up 4.2% year-on-year.
1 US market share of Somatuline® in the sales of
somatostatin analogs for acromegaly 2 With the
"Tiers-Payant" regulation, the patient now pays upfront for a branded
drug and is reimbursed only later on
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