[October 29, 2014] |
|
Ipsen: sales in the 3rd quarter and first nine months of 2014
PARIS --(Business Wire)--
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today reported its sales for the third
quarter and first nine months of 2014.
Unaudited IFRS consolidated sales
|
|
|
|
|
|
|
|
3rd quarter
|
|
Nine months
|
|
|
|
|
|
(in million euros)
|
|
2014
|
|
2013
|
|
% Variation
|
|
%
Variation at constant currency
|
|
2014
|
|
2013
|
|
% Variation
|
|
%
Variation at constant currency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SALES BY REGION
|
|
|
|
|
|
|
|
|
Major Western European countries
|
|
123.8
|
|
119.0
|
|
4.0%
|
|
3.1%
|
|
380.9
|
|
375.8
|
|
1.4%
|
|
0.8%
|
Other European countries
|
|
79.1
|
|
78.1
|
|
1.3%
|
|
3.9%
|
|
244.2
|
|
245.8
|
|
-0.7%
|
|
3.2%
|
North America
|
|
26.4
|
|
13.5
|
|
95.8%
|
|
96.5%
|
|
57.9
|
|
50.0
|
|
15.8%
|
|
19.7%
|
Rest of the world
|
|
99.7
|
|
87.5
|
|
13.9%
|
|
14.1%
|
|
284.7
|
|
260.1
|
|
9.5%
|
|
13.5%
|
Group Sales
|
|
329.0
|
|
298.1
|
|
10.4%
|
|
10.8%
|
|
967.7
|
|
931.8
|
|
3.9%
|
|
5.9%
|
|
|
|
|
|
|
|
|
|
|
SALES BY THERAPEUTIC AREA
|
|
|
|
|
|
|
|
|
Specialty care
|
|
245.7
|
|
211.9
|
|
16.0%
|
|
15.7%
|
|
718.2
|
|
661.3
|
|
8.6%
|
|
10.4%
|
Primary care
|
|
78.9
|
|
77.8
|
|
1.5%
|
|
3.6%
|
|
237.7
|
|
242.6
|
|
-2.0%
|
|
1.1%
|
Total Drug Sales
|
|
324.6
|
|
289.6
|
|
12.1%
|
|
12.5%
|
|
955.9
|
|
903.9
|
|
5.8%
|
|
7.9%
|
Drug-related sales*
|
|
4.4
|
|
8.5
|
|
-47.8%
|
|
-48.3%
|
|
11.8
|
|
27.9
|
|
-57.7%
|
|
-57.9%
|
Group Sales
|
|
329.0
|
|
298.1
|
|
10.4%
|
|
10.8%
|
|
967.7
|
|
931.8
|
|
3.9%
|
|
5.9%
|
* 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 accounting2.
Commenting on the first nine months of 2014 performance, Marc de
Garidel, Chairman and Chief Executive Officer of Ipsen, stated:
"Sales were strong in the third quarter, driven by the acceleration of
Somatuline® growth, the sustained rebound of
Decapeptyl®, and the exceptional orders of
Dysport® by Galderma. This led us to revise our
annual guidance for specialty care sales and profitability upward."
1 Year-on-year sales growth excluding foreign exchange impacts 2
In accordance with the norm IFRS11 « Partnerships » applicable
since 1st January 2014 on the accounting treatment of joint
ventures
Marc de Garidel added: "In terms of external growth, we
are pleased to have signed a license agreement with Lexicon, whose
compound in the treatment of carcinoid syndrome will reinforce the
Somatuline® franchise in neuroendocrine
tumours."
Highlights of the third quarter and first nine
months 2014 sales:
Note: Unless stated otherwise, all variations in sales are stated
excluding foreign exchange impacts and are computed by restating the
nine months 2013 sales with the nine months 2014 exchange rates.
The Group's consolidated sales reached €329.0 million in the
third quarter 2014, up 10.8% year-on-year. The Group's consolidated
sales amounted to €967.7 million in the first nine months 2014, up 5.9%
year-on-year.
In the third quarter 2014, sales of Specialty care products
reached €245.7 million, up 15.7% year-on-year. In the first nine months
2014, sales amounted to €718.2 million, up 10.4%. Sales in
urology-oncology, endocrinology, and neurology grew by respectively
10.3%, 11.6% and 9.0%. In the first nine months 2014, the relative
weight of specialty care products continued to increase to reach 74.2%
of total Group sales, compared to 71.0% the previous year. In the first
nine months 2014, specialty care growth was driven by:
-
The acceleration of Somatuline® growth, supported by solid
performance in the United States and Europe. The franchise enjoys a
positive dynamics in the neuroendocrine tumor space following the
publication of the positive CLARINET® clinical phase III
results and the submission of marketing authorization applications in
the US and Europe;
-
Dysport® sales growth, which benefited from exceptional
orders in aesthetic medicine placed by Valeant and taken over by
Galderma following the agreement signed between Ipsen and Galderma in
July 2014, as well as from the good performance of therapeutic sales
in Brazil;
-
The solid rebound of Decapeptyl®, after a particularly
difficult year 2013 in China and the Middle East. In 2013, sales in
China were affected by the disruption of hospital promotion and the
launch of local competitors on gynaecological indications, while in
the Middle East Ipsen had stopped supplying its products in certain
countries of the region due to the absence of payment guarantees.
In the third quarter 2014, sales of Primary care products reached
€78.9 million, up 3.6% year-on-year. In the first nine months 2014,
sales amounted to €237.7 million, up 1.1%. In France, sales declined
8.3% over the period, affected by two price cuts and a decrease in
volumes on Smecta®, and the launch of a competing product to
Tanakan® in March 2013. International sales exhibited solid
performance in China, Algeria and Russia, offsetting the decline in
France. Primary care sales in France accounted for 27.6% of the Group's
total primary care sales, compared to 30.7% the previous year.
In the third quarter 2014, sales generated in the Major Western
European countries reached €123.8 million, up 3.1% year-on-year. In
the first nine months 2014, sales amounted to €380.9 million, up 0.8%.
Sales in the Major Western European countries represented 39.4% of total
Group sales in the first nine months 2014, compared to 40.3% the
previous year.
In the third quarter 2014, sales generated in the Other European
countries reached €79.1 million, up 3.9% year-on-year. In the first
nine months 2014, sales amounted to €244.2 million, up 3.2%, 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 8.8%, mainly driven by volume growth in
Russia, where Tanakan® benefited from a media campaign and
from 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, Denmark, Kazakhstan and Austria. Sales were impacted by the
consequences of the political crisis ongoing in Ukraine. In the first
nine months 2014, sales in this region represented 25.2% of consolidated
Group sales, compared to 26.4% the previous year.
1 In accordance with the norm IFRS11 « Partnerships »
applicable since 1st January 2014 on the accounting treatment
of joint ventures
In the third quarter 2014, sales generated in North America
reached €26.4 million, up 96.5% year-on-year, driven by the resumption
of Increlex® supply in June 2014, the strong 41.7% Somatuline®
growth, and the exceptional deliveries made to Galderma in
aesthetic medicine. In the first nine months 2014, sales amounted to
€57.9 million, up 19.7%, affected by the supply interruption of Increlex®
in the first half of the year. Restated for Increlex® supply
interruption, sales increased 36.3% in the first nine months. Sales in
North America represented 6.0% of consolidated Group sales, compared to
5.4% a year earlier.
In the third quarter 2014, sales generated in the Rest of the World
reached €99.7 million, up 14.1% year-on-year. In the first nine months
2014, sales amounted to €284.7 million, up 13.5%, boosted by a
favourable base effect in the Middle East, where Ipsen had stopped
supplying its products in certain countries of the region due to the
absence of payment guarantees in 2013. 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 medicine. In the first nine months 2014, sales in the
Rest of the World have continued their progression to reach 29.4% of
total consolidated Group sales, compared to 27.9% the previous year.
2014 objectives raised
|
|
|
|
|
|
|
Current guidance
|
|
Revised guidance
|
Specialty care sales growth
|
|
6.0% - 8.0%
|
|
9.0% - 10.0%
|
Primary care sales growth
|
|
(1.0%) - 1.0%
|
|
(1.0%) - 1.0%
|
Core Operating Income margin
|
|
19.0% - 20.0%
|
|
Around 20.0%
|
In the first nine months of the year, some favorable factors led the
Group to revise its objectives for 2014:
-
Year-on-year growth of specialty care sales between 9.0% and 10.0%,
resulting from good sales performance in the first nine months of the
year. However, the Group expects a slowdown in the fourth quarter due
to a normalization of order levels by Galderma and of Decapeptyl®
growth in China, as well as to limited growth in Russia;
-
Year-on-year growth of primary care sales between -1.0% and 1.0%,
excluding the reimbursement of Smecta®'s generic in France;
-
Core operating margin around 20.0% of sales, resulting from the
solid sales performance, partially offset by an acceleration of
spending in the United States to prepare for the launch of Somatuline®
in neuroendocrine tumours following the priority review granted by FDA
(Food and Drug Administration).
The above objectives are set at constant exchange rates.
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 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
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).
-
The Group is faced with uncertainty in relation to the prices set for
all its products, in so far as medication prices have come under
severe pressure over the last few years as a result of various
factors, including the tendency for governments and payers to reduce
prices or reimbursement rates for certain drugs marketed by the Group
in the countries in which it operates, or even to remove those drugs
from lists of reimbursable drugs.
-
The Group depends on third parties to develop and market some of its
products, which generates or may generate substantial royalties for
the Group, but these third parties could behave in ways that cause
damage to the Group's business. The Group cannot be certain that its
partners will fulfill their obligations. It might be unable to obtain
any benefit from those agreements. A default by any of the Group's
partners could generate lower revenues than expected. Such situations
could have a negative impact on the Group's business, financial
position or performance.
-
Actual results may depart significantly from the objectives given that
a new product can appear to be promising at a development stage, or
after clinical trials, but never be launched on the market, or be
launched on the market but fail to sell, notably for regulatory or
competitive reasons.
-
The Research and Development process typically lasts between eight and
twelve years from the date of discovery to a product being brought to
market. This process involves several stages; at each stage, there is
a substantial risk that the Group could fail to achieve its objectives
and be forced to abandon its efforts in respect of products in which
it has invested significant amounts. Thus, in order to develop viable
products from a commercial point of view, the Group must demonstrate,
by means of pre-clinical and clinical trials, that the molecules in
question are effective and are not harmful to humans. The Group cannot
be certain that favorable results obtained during pre-clinical trials
will subsequently be confirmed during clinical trials, or that the
results of clinical trials will be sufficient to demonstrate the
safety and efficacy of the product in question such that the required
marketing approvals can be obtained.
-
The Group must deal with or may have to deal with competition (i) from
generic products, particularly in relation to Group products which are
not protected by patents, such as Forlax® and Smecta®
(ii), products which, although they are not strictly identical to the
Group's products or which have not demonstrated their bioequivalence,
may obtain a marketing authorization for indications similar to those
of the Group's products pursuant to the bibliographic reference
regulatory procedure (well established medicinal use) before the
patents protecting its products expire. Such a situation could result
in the Group losing market share which could affect its current level
of growth in sales or profitability.
-
Third parties might claim the benefit of intellectual property rights
with respect to the Group's inventions. The Group provides the third
parties with which it collaborates (including universities and other
public or private entities) with information and data in various forms
relating to the research, development, manufacturing and marketing of
its products. Despite the precautions taken by the Group with regard
to these entities, in particular of a contractual nature, they (or
certain of their members or affiliates) could claim ownership of
intellectual property rights arising from the trials carried out by
their employees or any other intellectual property right relating to
the Group's products or molecules in development.
-
The Group's strategy includes acquiring companies or assets which may
enable or facilitate access to new markets, research projects or
geographical regions or enable the Group to realize synergies with its
existing businesses. Should the growth prospects or earnings potential
of such assets as well as valuation assumptions change materially from
initial assumptions, the Group might be under the obligation to adjust
the values of these assets in its balance sheet, thereby negatively
impacting its results and financial situation.
-
The marketing of certain products by the Group has been and could be
affected by supply shortages and other disruptions. Such difficulties
may be of both a regulatory nature (the need to correct certain
technical problems in order to bring production sites into compliance
with applicable regulations) and a technical nature (difficulties in
obtaining supplies of satisfactory quality or difficulties in
manufacturing active ingredients or drugs complying with their
technical specifications on a sufficiently reliable and uniform
basis). This situation may result in inventory shortages and/or in a
significant reduction in the sales of one or more products. More
specifically, in their US Hopkinton facility, Lonza, our supplier of
IGF-1 (Increlex® drug substance), has 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.
-
In certain countries exposed to significant public deficits, and where
the Group sells its drugs directly to public hospitals, the Group
could face discount or lengthened payment terms or difficulties in
recovering its receivables in full. The Group closely monitors the
evolution of the situation in Southern Europe where hospital payment
terms are especially long. More generally, the Group may also be
unable to purchase sufficient credit insurance to protect itself
adequately against the risk of payment default from certain customers
worldwide. Such situations could negatively impact the Group's
activities, financial situation and results.
-
In the normal course of business, the Group is or may be involved in
legal or administrative proceedings. Financial claims are or may be
brought against the Group in connection with some of these proceedings.
-
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 the first nine months of 2014, major developments included:
-
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.
-
On 14 January 2014 - Ipsen and GW Pharmaceuticals plc announced that
they have entered into an exclusive agreement for Ipsen to promote and
distribute Sativex®, a sublingual cannabis extract spray
intended for the treatment of spasticity due to multiple sclerosis in
Latin America (excluding Mexico and the Islands of the Caribbean). GW
will be responsible for commercial product supply to Ipsen. GW
Pharmaceuticals and Ipsen aim to start regulatory filings in selected
countries in Latin America during 2014 for the multiple sclerosis
spasticity indication.
-
On 14 January 2014 - Ipsen announced its decision to set up its own
oncology team to commercialize Somatuline® Depot®
(lanreotide) 120 mg Injection (« Somatuline® ») in
neuroendocrine tumors in the US. Over the past few months, the Group
had been considering both a "go-it-alone" and a partnership strategy
following the communication of the data from the investigational
CLARINET® phase III clinical study evaluating the
antiproliferative effect of Somatuline® in the treatment of
non-functioning gastrointestinal & pancreatic NETs (GEP NETs). Ipsen
expects that these encouraging results will support a key long-term
opportunity for the Group to access an US addressable market in excess
of $500 million1. Ipsen considers success in the US
as a strategic priority. The "go-it-alone" option maximizes long term
value creation and helps the US affiliate in reaching critical mass.
Ipsen
anticipates filing a Supplemental New Drug Application seeking an
indication for Somatuline® in NETs in the first half of
2014. Maximum incremental annual cost associated with the launch of
Somatuline® in the NET indication in the US is expected to
range from €30 million to €40 million. As a result, US breakeven2,
initially expected in 2014, is postponed to 2017. Ipsen will continue
to implement cost containment initiatives to minimize impact on
overall Group profitability.
-
On 17 January 2014 - Ipsen announced at ASCO GI that ELECT®
clinical trial of Somatuline® in the control of symptoms in
GEP-NET patients with carcinoid syndrome met its primary endpoint.
Results of the ELECT® phase III study (poster 268) showed
that treatment with Somatuline® 120 mg versus placebo
resulted in a statistically significant reduction in the number of
days in which immediate release octreotide was used as rescue
medication, representing a mean difference of -14.8% (95%CI: -26.8,
-2.8; p = 0.017). Somatuline® significantly improved the
rates of complete/partial treatment success versus placebo (odds ratio
= 2.4; 95%CI: 1.1, 5.3; p = 0.036).
-
On 22 January 2014 - Ipsen announced the implementation of new
governance in the United States, following its recently announced
decision to launch Somatuline® for oncology indications.
Marc de Garidel will personally oversee this projected launch. Cynthia
Schwalm will join Ipsen's US Operations to head up the
Endocrinology/Oncology Business Unit as of 3 February, 2014. As of
mid-August 2014, she will take over as General Manager of the US
commercial affiliate.
-
On 5 February 2014 - Ipsen announced the results of the international
Phase III clinical trial of Dysport® Next Generation (DNG)
in cervical dystonia and the results of the European Phase II clinical
trial of DNG in glabellar lines. In the light of these results, Ipsen
announces its intention to file the first ready-to-use liquid toxin A
in Europe and in the Rest of the World3 (ROW). DNG was
clinically and statistically superior to placebo in the cervical
dystonia Phase III study at the dose of 500 units at week 4 after
single dose (adjusted mean reduction of 12.5 with DNG versus 3.9 with
placebo as assessed by the Toronto Western Spasmodic Torticollis
Rating Scale, or TWSTRS, total score). When compared to Dysport®,
DNG did not demonstrate the statistical non-inferiority in efficacy at
week 4 (adjusted mean reduction of 12.5 with DNG versus 14.0 with
Dysport® in TWSTRS total score). This efficacy difference
is unlikely to be of clinical relevance. After repeated dose, DNG
showed comparable efficacy to that of Dysport® as observed
in former Phase III studies4. DNG was clinically and
statistically superior to placebo and comparable to Dysport®
in the glabellar lines Phase II study at the dose of 50 units after
single dose. Across the studies, DNG showed safety profiles consistent
with the known safety profile of Dysport®. Regarding DNG
stability, analysis is still ongoing. The stability data trends are
positive, providing confidence of achieving a commercially viable
product. Ipsen is continuing stability testing to establish maximum
shelf life across full product range. On the basis of these results
and feedback from the Principal Investigator of the Phase III study,
Ipsen intends to initiate a dialog with key agencies on the regulatory
approach to file the first ready-to-use liquid toxin A in Europe and
ROW1.
1 Ipsen 2013 estimates of US NET market 2
Commercial contribution excluding Increlex® (mecasermin [rDNA
origin]) Injection sales and revenues from US collaboration with Valeant
Pharmaceuticals Intl Inc. 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
-
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.
-
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.
1 Latin America, Middle East and Asia (excl. China and Japan) 2
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 Europe1 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®.
1 Excluding Russia
-
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.
-
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.
After 30 September 2014, major developments included:
-
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.
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 impacting 2014
In the Major Western European countries:
-
In France, the price of Smecta® was cut by 7.5% as of 1st
July 2014, after a first price cut of the same magnitude as of 1st
January 2014. In April 2014, Mylan launched a diosmectite generic (not
reimbursed to date). 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 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 €2.0 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. In addition, Dysport® obtained reimbursement in
spasticity indications, effective from July 2014 to July 2016. In
Primary Care, the price of Fortrans® was raised by 10.0% in
September 2014 thanks to strong support from the Polish Endoscopy
Medical Society;
-
In Portugal, the Ministry of Health is pressurizing the local
pharmaceutical association (APIFARMA) in the context of negotiations
with the industry on the 2014 spending exceeding a certain threshold.
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 Romania, the Ministry of Health published new Health Technology
Assessment (HTA) guidelines in June 2014 to be applied to drugs
already reimbursed and to new molecules pending a reimbursement
decision;
-
In Slovenia, the official price of Dysport® was decreased
in June 2014 to be aligned with the reimbursed price;
-
In Slovakia, in April 2014, Ipsen submitted prices for the second
yearly revision based on the average of the 3 lowest prices in EU 28,
leading to price decreases on all Ipsen products;
-
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 will benefit from a
1.0% price increase in 2014;
-
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 increased.
However the mandatory reimbursement discount 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 Social Security Finance Bill (PLFSS) for 2014
introduced, for the first time, the possibility for the pharmacist to
substitute biotechnology products with biosimilars, except when the
physician forbids it on the prescription. This rule has not yet been
enacted pending the publication of a decree. In addition, the French
government has presented the new Social Security Finance Bill (PLFSS)
which sets forth expenditure targets in the healthcare sector for
2015. For the first time, the Social Security Finance Bill for 2015
sets a negative threshold (L = -1%) triggering the safeguard clause
(contribution borne by pharmaceutical companies). The L rate
represents the "authorized" evolution of reimbursed drug spending.
Moreover, the budgeted drug price decreases for 2015 would amount to
900 million euros. In addition, Decapeptyl® will experience
a 3.0% price decrease as of 1st January 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 cancelled;
-
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 Croatia, Czech Republic replaced France in the basket of countries
included in the international reference pricing system;
-
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 increase 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 South Africa, the Department of Health has published draft
legislation governing pricing of novel drugs in the country. The
guidelines set forth a potential international reference pricing. No
timeline for advancement is yet known;
-
In Tunisia, the creation of a National Medicines Agency ("Agence
nationale du Médicament") is at an advanced stage of preparation.
The Ministry of Health has updated existing texts on regulatory and
clinical requirements so as to meet the highest international
standards;
-
In Turkey, authorities are contemplating the opportunity to introduce
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 third quarters and first
nine months 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
nine months 2013 sales with the nine months 2014 exchange rates.
The following table shows sales by therapeutic area and by product for
the third quarters and first nine months 2014 and 2013:
|
|
3rd quarter
|
|
9 months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in million euros)
|
|
2014
|
|
2013
|
|
% Variation
|
|
% Variation at constant currency
|
|
2014
|
|
2013
|
|
% Variation
|
|
% Variation at constant currency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urology-oncology
|
|
86.7
|
|
79.0
|
|
9.8%
|
|
10.0%
|
|
255.5
|
|
233.5
|
|
9.4%
|
|
10.3%
|
of which Hexvix®
|
|
3.8
|
|
3.2
|
|
15.5%
|
|
15.2%
|
|
12.1
|
|
10.7
|
|
13.2%
|
|
12.9%
|
of which Decapeptyl®
|
|
82.9
|
|
75.7
|
|
9.5%
|
|
9.8%
|
|
243.4
|
|
222.9
|
|
9.2%
|
|
10.2%
|
Endocrinology
|
|
92.0
|
|
77.2
|
|
19.2%
|
|
18.7%
|
|
267.1
|
|
241.4
|
|
10.7%
|
|
11.6%
|
of which Somatuline®
|
|
74.3
|
|
63.2
|
|
17.5%
|
|
17.2%
|
|
213.6
|
|
186.6
|
|
14.4%
|
|
15.5%
|
of which NutropinAq®
|
|
14.2
|
|
13.2
|
|
8.1%
|
|
7.7%
|
|
45.1
|
|
42.3
|
|
6.6%
|
|
6.7%
|
of which Increlex®
|
|
3.5
|
|
0.8
|
|
329.3%
|
|
279.2%
|
|
8.5
|
|
12.5
|
|
-32.2%
|
|
-30.8%
|
Neurology
|
|
67.0
|
|
55.7
|
|
20.2%
|
|
19.5%
|
|
195.6
|
|
186.3
|
|
4.9%
|
|
9.0%
|
of which Dysport®
|
|
66.7
|
|
55.8
|
|
19.6%
|
|
18.9%
|
|
195.3
|
|
186.3
|
|
4.8%
|
|
8.8%
|
Specialty care
|
|
245.7
|
|
211.9
|
|
16.0%
|
|
15.7%
|
|
718.2
|
|
661.3
|
|
8.6%
|
|
10.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastroenterology
|
|
56.1
|
|
54.2
|
|
3.6%
|
|
5.4%
|
|
166.7
|
|
168.2
|
|
-0.9%
|
|
2.1%
|
of which Smecta®
|
|
33.8
|
|
30.5
|
|
11.0%
|
|
13.2%
|
|
94.6
|
|
92.2
|
|
2.6%
|
|
6.0%
|
of which Forlax®
|
|
9.5
|
|
8.8
|
|
8.2%
|
|
8.8%
|
|
28.3
|
|
29.4
|
|
-3.7%
|
|
-2.9%
|
Cognitive disorders
|
|
16.4
|
|
16.0
|
|
2.3%
|
|
6.2%
|
|
47.5
|
|
48.7
|
|
-2.3%
|
|
2.7%
|
of which Tanakan®
|
|
16.4
|
|
16.0
|
|
2.3%
|
|
6.2%
|
|
47.5
|
|
48.7
|
|
-2.3%
|
|
2.7%
|
Cardiovascular
|
|
3.8
|
|
4.6
|
|
-16.3%
|
|
-16.1%
|
|
15.1
|
|
16.7
|
|
-9.6%
|
|
-9.3%
|
of which Nisis® & Nisisco®
|
|
1.6
|
|
1.9
|
|
-17.9%
|
|
-17.9%
|
|
5.0
|
|
6.0
|
|
-17.0%
|
|
-17.0%
|
of which Ginkor®
|
|
2.2
|
|
2.4
|
|
-9.4%
|
|
-9.0%
|
|
9.5
|
|
10.1
|
|
-5.2%
|
|
-4.7%
|
Other Primary Care
|
|
2.6
|
|
3.0
|
|
-13.2%
|
|
-12.9%
|
|
8.3
|
|
8.9
|
|
-7.1%
|
|
-6.9%
|
of which Adrovance®
|
|
2.3
|
|
2.6
|
|
-12.7%
|
|
-12.7%
|
|
6.9
|
|
7.8
|
|
-11.3%
|
|
-11.3%
|
Primary care
|
|
78.9
|
|
77.8
|
|
1.5%
|
|
3.6%
|
|
237.7
|
|
242.6
|
|
-2.0%
|
|
1.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Drug Sales
|
|
324.6
|
|
289.6
|
|
12.1%
|
|
12.5%
|
|
955.9
|
|
903.9
|
|
5.8%
|
|
7.9%
|
Drug-related Sales*
|
|
4.4
|
|
8.5
|
|
-47.8%
|
|
-48.3%
|
|
11.8
|
|
27.9
|
|
-57.7%
|
|
-57.9%
|
Group Sales
|
|
329.0
|
|
298.1
|
|
10.4%
|
|
10.8%
|
|
967.7
|
|
931.8
|
|
3.9%
|
|
5.9%
|
*Active ingredients and raw materials
In the third quarter 2014, sales of Specialty care products
reached €245.7 million, up 15.7% year-on-year. In the first nine months
2014, sales amounted to €718.2 million, up 10.4%. Sales in
urology-oncology, endocrinology, and neurology grew by respectively
10.3%, 11.6% and 9.0%. In the first nine months 2014, the relative
weight of specialty care products continued to increase to reach 74.2%
of total Group sales, compared to 71.0% the previous year.
In Urology-oncology, sales of Decapeptyl®
reached €82.9 million in the third quarter 2014, up 9.8% year-on-year.
In the first nine months 2014, sales amounted to €243.4 million, up
10.2%, boosted by a favorable base effect in the Middle East, where
Ipsen had stopped supplying its products in 2013 due to the absence of
payment guarantees, and in China, where 2013 was marked by the
disruption of hospital promotion. The performance of Decapeptyl® 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 the first nine months 2014, sales of Hexvix®
amounted to €12.1 million, up 12.9% compared to 2013, mainly generated
in Germany. Over the period, sales in Urology-oncology represented 26.4%
of total Group sales, compared to 25.1% the previous year.
In Endocrinology, sales reached €92.0 million in the third
quarter 2014, up 18.7% year-on-year. In the first nine months 2014,
sales amounted to €267.1 million, up 11.6%, and represented 27.6% of
total Group sales, compared to 25.9% the previous year.
Somatuline® - In the third quarter 2014, sales
reached €74.3 million, up 17.2% year-on-year. In the first nine months
2014, sales of Somatuline® grew 15.5% to €213.6 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® was penalized by a price
cut in Columbia and recorded good performance in Spain, France, the
Netherlands, Denmark and Belgium.
NutropinAq® - In the third quarter 2014, sales
reached €14.2 million, up 7.7% compared to the same period in 2013. In
the first nine months 2014, sales of NutropinAq® amounted to
€45.1 million, up 6.7% year-on-year, driven by good performance in
Germany and France.
Increlex® - In the third quarter 2014, sales
reached €3.5 million, up 279.2% compared to the same period in 2013. In
the first nine months 2014, sales of Increlex® amounted to
€8.5 million, down 30.8% year-on-year, mainly affected by 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 Neurology, Dysport® sales reached
€66.7 million in the third quarter 2014, up 18.9% year-on-year. In the
first nine months 2014, Dysport® sales amounted to
€195.3 million, up 8.8%, driven by the solid volume performance of the
therapeutic and aesthetic segments in Brazil, and by the supply of the
product to Galderma for aesthetic use. Growth was affected by intense
price competition in South Korea and Brazil but benefited in Germany
from the aforementioned reduction in mandatory rebates. Neurology sales
represented 20.2% of total Group sales in 2014, compared to 20.0% a year
earlier.
In the third quarter 2014, sales of Primary care products reached
€78.9 million, up 3.6% year-on-year. In the first nine months 2014,
sales amounted to €237.7 million, up 1.1%. In France sales declined 8.3%
over the period, affected by two price cuts and a decrease in volumes on
Smecta®, and the launch of a competing product to Tanakan®
in March 2013. International sales exhibited solid performance in
China, Algeria and Russia, offsetting the decline in France. Primary
care sales in France accounted for 27.6% of the Group's total primary
care sales, compared to 30.7% the previous year.
In Gastroenterology, sales reached €56.1 million in the third
quarter 2014, up 5.4% year-on-year. In the first nine months 2014, sales
amounted to €166.7 million euros, up 2.1% compared to 2013.
Smecta® - In the third quarter 2014, sales
reached €33.8 million, up 13.2% year-on-year. In the first nine months
2014, sales amounted to €94.6 million euros, up 6.0%, driven by solid
growth in Russia, Algeria and China, but affected in France by the 7.5%
price cuts implemented in January and July 2014 and a low level of
gastroenteritis epidemic compared to last year. Smecta® sales
represented 9.8% of total Group sales over the period, compared to 9.9%
the previous year.
Forlax® - In the third quarter 2014, sales
reached €9.5 million, up 8.8% year-on-year. In the first nine months
2014, sales amounted to €28.3 million euros, down 2.9%, 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 46.2% of total product sales,
compared to 50.6% the previous year.
1 With the "Tiers-Payant" regulation, the patient now pays
upfront for a branded drug and is reimbursed only later on
In the cognitive disorders area, sales of Tanakan®
reached €16.4 million euros in the third quarter 2014, up 6.2%
year-on-year. Sales in the first nine months 2014 amounted to €47.5
million euros, up 2.7%, driven by the good performance of the product in
Russia. Growth is partially offset 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 the first
nine months 2014, 22.8% of Tanakan® sales were achieved in
France, compared to 25.9% the previous year.
In the cardiovascular area, sales reached €3.8 million euros in
the third quarter 2014, down 16.1% year-on-year. In the first nine
months 2014, sales amounted to €15.1 million euros, down 9.3% 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 €2.6 million
in the third quarter 2014, down 12.9% year-on-year. In the first nine
months 2014, sales amounted to €8.3 million, down 6.9%, mainly affected
by the 11.3% decline in Adrovance® sales.
In the third quarter 2014, drug-related sales (active ingredients and
raw materials) reached €4.4 million, down 48.3% year-on-year.
In the first nine months 2014, sales amounted to €11.8 million euros,
down 57.9%. 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 accounting1. Restated for this base effect,
sales declined 25.6%.
1 In accordance with the norm IFRS11 « Partnerships »
applicable since 1st January 2014 on the accounting treatment
of joint ventures
Sales by geographical area
Group sales by geographical area in the third quarters and first nine
months 2014 and 2013 were as follows:
|
|
3rd quarter
|
|
9 months
|
|
|
|
|
|
(in million euros)
|
|
2014
|
|
2013
|
|
% Variation
|
|
% Variation at constant currency
|
|
2014
|
|
2013
|
|
% Variation
|
|
% Variation at constant currency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
France
|
|
51.4
|
|
51.8
|
|
-0.8%
|
|
-0.8%
|
|
158.0
|
|
165.3
|
|
-4.4%
|
|
-4.4%
|
United Kingdom
|
|
16.9
|
|
14.3
|
|
18.3%
|
|
9.6%
|
|
47.2
|
|
41.9
|
|
12.7%
|
|
7.4%
|
Spain
|
|
15.1
|
|
14.1
|
|
7.0%
|
|
7.0%
|
|
44.3
|
|
42.6
|
|
4.0%
|
|
4.0%
|
Germany
|
|
23.4
|
|
20.6
|
|
13.7%
|
|
13.7%
|
|
70.5
|
|
63.5
|
|
11.1%
|
|
11.1%
|
Italy
|
|
17.0
|
|
18.2
|
|
-6.6%
|
|
-6.6%
|
|
60.8
|
|
62.5
|
|
-2.7%
|
|
-2.7%
|
Major Western European countries
|
|
123.8
|
|
119.0
|
|
4.0%
|
|
3.1%
|
|
380.9
|
|
375.8
|
|
1.4%
|
|
0.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eastern Europe
|
|
43.4
|
|
42.7
|
|
1.6%
|
|
6.2%
|
|
134.0
|
|
135.8
|
|
-1.3%
|
|
5.6%
|
Others Europe
|
|
35.8
|
|
35.4
|
|
0.9%
|
|
1.2%
|
|
110.1
|
|
110.1
|
|
0.1%
|
|
0.5%
|
Other European Countries
|
|
79.1
|
|
78.1
|
|
1.3%
|
|
3.9%
|
|
244.2
|
|
245.8
|
|
-0.7%
|
|
3.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
26.4
|
|
13.5
|
|
95.8%
|
|
96.5%
|
|
57.9
|
|
50.0
|
|
15.8%
|
|
19.7%
|
Asia
|
|
52.3
|
|
50.4
|
|
3.7%
|
|
5.3%
|
|
144.5
|
|
135.6
|
|
6.6%
|
|
9.7%
|
Other countries in the Rest of the world
|
|
47.4
|
|
37.1
|
|
27.8%
|
|
25.8%
|
|
140.2
|
|
124.5
|
|
12.6%
|
|
17.7%
|
Rest of the World
|
|
99.7
|
|
87.5
|
|
13.9%
|
|
14.1%
|
|
284.7
|
|
260.1
|
|
9.5%
|
|
13.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group Sales
|
|
329.0
|
|
298.1
|
|
10.4%
|
|
10.8%
|
|
967.7
|
|
931.8
|
|
3.9%
|
|
5.9%
|
Of which: Total Drug Sales
|
|
324.6
|
|
289.6
|
|
12.1%
|
|
12.5%
|
|
955.9
|
|
903.9
|
|
5.8%
|
|
7.9%
|
Drug-related Sales*
|
|
4.4
|
|
8.5
|
|
-47.8%
|
|
-48.3%
|
|
11.8
|
|
27.9
|
|
-57.7%
|
|
-57.9%
|
* Active ingredients and raw materials
In the third quarter 2014, sales generated in the Major Western
European countries reached €123.8 million, up 3.1% year-on-year. In
the first nine months 2014, sales amounted to €380.9 million, up 0.8%.
Sales in the Major Western European countries represented 39.4% of total
Group sales in the first nine months 2014, compared to 40.3% the
previous year.
France - In the third quarter 2014, sales reached €51.4 million,
slightly down 0.8% year-on-year. In the first nine months 2014, sales
amounted to €158.0 million, down 4.4%, 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 consecutive 7.5% price cuts implemented in
January and July 2014. Moreover, sales of Forlax® suffered
from generics competition while Tanakan® has continued to be
impacted by the launch of a second "me-too" product in March 2013. Sales
of specialty care products, up 1.7% over the period, were driven by the
sustained growth of Somatuline® and NutropinAq®
sales, partly offset by the decrease in Decapeptyl® sales,
both in volume and value with 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 16.3% of
sales, compared to 17.7% the previous year.
United Kingdom - In the third quarter 2014, sales reached €16.9
million, up 9.6% year-on-year. In the first nine months 2014, sales
amounted to €47.2 million, up 7.4%, fueled by the double-digit volume
growth of Somatuline® and Decapeptyl®, but
affected by the decline in Dysport® sales. In the first nine
months 2014, the United Kingdom represented 4.9% of total Group sales,
compared to 4.5% the previous year.
Spain - In the third quarter 2014, sales reached €15.1 million,
up 7.0% year-on-year. In the first nine months 2014, sales amounted to
€44.3 million, up 4.0%, 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 the
first nine months 2014, sales in Spain were in line with last year at
4.6% of total Group sales.
Germany - In the third quarter 2014, sales reached €23.4
million, up 13.7% year-on-year. In the first nine months 2014, sales
reached €70.5 million, up 11.1%. 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 7.3%
of total Group sales, compared to 6.8% a year earlier.
Italy - In the third quarter 2014, sales reached €17.0 million,
down 6.6% year-on-year. In the first nine months 2014, sales reached
€60.8 million, down 2.7%. The growth of Somatuline® was not
enough to offset the impact of austerity control measures targeting
hospital products. In the first nine months 2014, Italy represented 6.3%
of total Group sales, compared to 6.7% the previous year.
In the third quarter 2014, sales generated in the Other European
countries reached €79.1 million, up 3.9% year-on-year. In the first
nine months 2014, sales amounted to €244.2 million, up 3.2%, 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 8.8%, mainly driven by volume growth in
Russia, where Tanakan® benefited from a media campaign and
from 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, Denmark, Kazakhstan and Austria. Sales were impacted by the
consequences of the political crisis ongoing in Ukraine. In the first
nine months 2014, sales in this region represented 25.2% of consolidated
Group sales, compared to 26.4% the previous year.
In the third quarter 2014, sales generated in North America
reached €26.4 million, up 96.5% year-on-year, driven by the resumption
of Increlex® supply in June 2014, the strong 41.7% Somatuline®
growth, and the exceptional orders made by Galderma in aesthetic
medicine. In the first nine months 2014, sales amounted to €57.9
million, up 19.7%, affected by the supply interruption of Increlex®
in the first half of the year. Restated for Increlex® supply
interruption, sales increased 36.3% in the first nine months. Sales in
North America represented 6.0% of consolidated Group sales, compared to
5.4% a year earlier.
In the third quarter 2014, sales generated in the Rest of the World
reached €99.7 million, up 14.1% year-on-year. In the first nine months
2014, sales amounted to €284.7 million, up 13.5%, boosted by a
favourable base effect in the Middle East, where Ipsen had stopped
supplying its products in certain countries of the region due to the
absence of payment guarantees in 2013. 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 the first nine months 2014, sales in the
Rest of the World have continued their progression to reach 29.4% of
total consolidated Group sales, compared to 27.9% the previous year.
1 In accordance with the norm IFRS11 « Partnerships » that
came into force as of 1st January 2014 on the accounting
treatment of joint ventures
[ Back To TMCnet.com's Homepage ]
|