[April 30, 2014] |
|
Ipsen's first quarter 2014 sales
PARIS --(Business Wire)--
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) reported today its sales for the first
quarter 2014.
First quarter 2014 unaudited IFRS consolidated sales
|
|
|
|
|
|
|
|
|
|
(in million euros)
|
|
2014
|
|
2013
|
|
% Change
|
|
% Change at constant currency
|
|
|
|
|
|
|
|
|
|
SALES BY REGION
|
|
|
|
|
|
|
|
|
Major Western European countries
|
|
129.3
|
|
127.6
|
|
1.3%
|
|
1.0%
|
Other European countries
|
|
81.6
|
|
81.7
|
|
-0.2%
|
|
4.5%
|
North America
|
|
14.3
|
|
17.3
|
|
-17.0%
|
|
-14.0%
|
Rest of the world
|
|
80.8
|
|
80.1
|
|
0.9%
|
|
6.1%
|
Group Sales
|
|
305.9
|
|
306.6
|
|
-0.2%
|
|
2.4%
|
|
|
|
|
|
|
|
|
|
SALES BY THERAPEUTIC AREA
|
|
|
|
|
|
|
|
|
Specialty care
|
|
225.3
|
|
217.0
|
|
3.8%
|
|
6.4%
|
Primary care
|
|
76.6
|
|
80.4
|
|
-4.7%
|
|
-1.7%
|
Total Drug Sales
|
|
301.9
|
|
297.3
|
|
1.5%
|
|
4.3%
|
Drug-related sales2
|
|
4.1
|
|
9.3
|
|
-56.3%
|
|
-56.4%
|
Group Sales
|
|
305.9
|
|
306.6
|
|
-0.2%
|
|
2.4%
|
Commenting on the first quarter 2014 performance, Marc de Garidel,
Chairman and Chief Executive Officer of Ipsen said: "Ipsen is off
to a good start this year with solid specialty care growth, up 6.4%1,
notably driven by the good performance of Somatuline® and
Dysport® and the return to growth of Decapeptyl®
in China. Moreover, Primary Care,
negatively impacted by a continuous decline in France, benefited from
strong international growth." Marc de Garidel added: "The
Group is paying special attention to the potential consolidations that
may alter the competitive landscape in its areas of interest."
1 Year-on-year growth excluding foreign exchange impacts 2
Drug related sales correspond to sales of active indredients and
raw materials
First quarter 2014 sales highlights
Note: Unless stated otherwise, all variations in sales are stated
excluding foreign exchange impacts by restating the Q1 2013 sales with
the Q1 2014 exchange rates.
Consolidated Group sales reached €305.9 million in the first
quarter 2014, up 2.4% year-on-year.
Drug sales reached €301.9 million in the first quarter 2014, up
4.3% year-on-year, fueled by the sales growth of Specialty Care products,
up 6.4% year-on-year. Sales in Uro-oncology, Endocrinology, and
Neurology grew by respectively 6.1%, 6.9% and 6.3% year-on-year. In the
first quarter 2014, the relative weight of specialty care products
continued to increase to reach 73.6% of total Group sales, compared to
70.8% the previous year.
Sales of Primary Care products amounted to €76.6 million, down
1.7% year-on-year. Sales recorded solid performance in China, Russia,
and Algeria. Sales in France declined by 15.3% year-on-year, affected by
the launch of a competitive product to Tanakan® in March
2013, the 7.5% price cut on Smecta® implemented as of 1st
January 2014, and the negative consequences arising from the
reinforcement of the "Tiers-Payant3" regulation.
Sales generated in the Major Western European countries amounted
to €129.3 million, up 1.0% year-on-year. The dynamic growth of specialty
care products was partially offset by the decline of French primary care
sales. Sales in the Major Western European countries represented 42.2%
of total Group sales in the first quarter 2014, compared to 41.6% the
previous year.
Sales generated in the Other European countries reached €81.6
million, up 4.5% year-on-year, penalized 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 accounting4. Restated for this base effect,
sales were up 10.2%. Moreover, sales were driven by solid volume growth
in Russia, where Dysport® continues to penetrate the
aesthetics and therapeutics markets and where Tanakan®
records strong growth, the supply of Dysport® for aesthetic
use to Galderma, and the solid performance of the Netherlands and the
Czech Republic. Sales were penalized by the consequences of the
political crisis ongoing in Ukraine. In the first quarter 2014, sales in
this region represented 26.7% of consolidated Group sales, a stable
ratio year-on-year.
Sales generated in North America reached €14.3 million, down
14.0% year-on-year, mainly impacted by the Increlex® supply
interruption that occurred in mid-June 2013. Restated for the Increlex®
supply interruption, sales were up 13.8% year-on-year, driven by the
solid volume and value growth of Somatuline®, and by the
solid performance of Dysport® in therapeutics and aesthetics
through the product supply to Valeant. Sales in North America
represented 4.7% of consolidated Group sales, compared to 5.6% a year
earlier.
Sales generated in the Rest of the World reached €80.8 million,
up 6.1% year-on-year. Performance was affected by a non-recurring effect
in Vietnam, where orders had been anticipated in the first quarter 2013
before the expiry of import licenses for certain primary care products.
Restated for this effect, sales were up 8.5%, driven by strong volume
growth in China (notably Decapeptyl® and Smecta®),
the Middle East and Brazil where Dysport® sales recorded good
performance in aesthetics and therapeutics. In the first quarter 2014,
sales in the Rest of the World accounted for 26.4% of total consolidated
Group sales, compared to 26.1% the previous year.
1 With the "Tiers-Payant" regulation, the patient now pays
upfront for a branded drug and is reimbursed only later on 2
In accordance with the norm IFRS11 « Partnerships » applicable since 1st
January 2014 on the accounting treatment of joint ventures
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.2 billion in 2013. Ipsen's ambition is to become a
leader in specialty healthcare solutions for targeted debilitating
diseases. Its development strategy is supported by 3 franchises:
neurology, endocrinology and uro-oncology. Moreover, the Group has an
active policy of partnerships. Ipsen's R&D is focused on its innovative
and differentiated technological platforms, peptides and toxins. In
2013, R&D expenditure totaled close to €260 million, representing more
than 21% of Group sales. Moreover, Ipsen also has a significant presence
in primary care. The Group has close to 4,600 employees worldwide.
Ipsen's shares are traded on segment A of Euronext Paris (stock code:
IPN, ISIN code: FR0010259150) and eligible to the "Service de Règlement
Différé" ("SRD"). The Group is part of the SBF 120 index. Ipsen has
implemented a Sponsored Level I American Depositary Receipt (ADR)
program, which trade on the over-the-counter market in the United States
under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein
are based on the Group's management strategy, current views and
assumptions. Such statements involve known and unknown risks and
uncertainties that may cause actual results, performance or events to
differ materially from those anticipated herein. All of the above risks
could affect the Group's future ability to achieve its financial
targets, which were set assuming reasonable macroeconomic conditions
based on the information available today. 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), is experiencing
manufacturing issues with Increlex®. Supply interruption
occurred in mid-June 2013 in the US and in Q3 2013 in Europe and the
rest of the world. On December 18th 2013, Ipsen announced
that Lonza had successfully re-manufactured the active ingredient of
Increlex® and that the European Medicines Agency (EMA) had
been informed that Ipsen was preparing for the resupply of Increlex®
in the European Union. Consultations with the National competent
authorities have allowed a resupply in Europe early 2014. Resupply in
the US is still pending. Ipsen is actively working with its third
party manufacturer and the Food and Drug Administration (FDA) to bring
Increlex® back to the US market as soon as possible.
-
In certain countries exposed to significant public deficits, and where
the Group sells its drugs directly to public hospitals, the Group
could face discount or lengthened payment terms or difficulties in
recovering its receivables in full. The Group closely monitors the
evolution of the situation in Southern Europe where hospital payment
terms are especially long. More generally, the Group may also be
unable to purchase sufficient credit insurance to protect itself
adequately against the risk of payment default from certain customers
worldwide. Such situations could negatively impact the Group's
activities, financial situation and results.
-
In the normal course of business, the Group is or may be involved in
legal or administrative proceedings. Financial claims are or may be
brought against the Group in connection with some of these proceedings.
-
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 quarter 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) during the 16-week double-blind phase of the study.
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
ROW5.
1 Ipsen 2013 estimates of US NET market 2
Commercial contribution excluding Increlex® (mecasermin [rDNA origin])
Injection sales and revenues from U.S. collaboration with Valeant
Pharmaceuticals Intl Inc. in aesthetic medicine 3 Latin
America, Middle East and Asia (ex Japan and China)
-
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%6 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 June 30, 2015.
1 Truong D. et al. Mov. Disord., 2005; 20 (7) 783-791; Truong
et al., Parkinsonism Relat Disord. 2010 Jun;16(5):316-23 2
Latin America, Middle East and Asia (ex Japan and China) 3
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
After 31 March 2014, major developments included:
-
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.
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 the first quarter 2014. In
addition, certain measures introduced in 2013 have continued to affect
the Group's accounts year-on-year.
Measures impacting the first quarter 2014:
In the Major Western European countries:
-
In France, health authorities have required price cuts of 5.5% on
NutropinAq® in June 2013, of 12.5% on Nisis®/Nisisco®
in October 2013, of 7.5% on Smecta® as of 1st
January 2014 (a second cut of the same magnitude will apply as of 1st
July 2014), of 6.5% on Fortrans® as of 1st
January 2014 and of 4.0% on Decapeptyl® as of 1st
April 2014. Moreover, Hexvix® has once again been
reimbursed on the list "en sus" since December 2013;
-
In the UK, the new PPRS (Pharmaceutical Price Regulation Scheme)
was implemented, with the option for pharmaceutical companies to apply
a price cut on the NHS (National Health Service) selling price
of 5.0% to 7.0%, modulated on the whole portfolio, or to repay this
amount through pay back. Moreover, since January 2014, tenders are
managed at the regional level instead of the hospital level;
-
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, a first draft of the Royal Decree was published by the
Ministry of Health in March 2014 announcing the implementation of an
international price reference system based on the lowest price per mg
in the 28 countries of the European Union. The application, which
could occur in June 2014, will affect all LhRH (Luteinizing
hormone-Releasing Hormone) analogues, including Decapeptyl®.
Moreover, prices negotiated with hospitals during tenders will
potentially be published and the official price would be aligned on
the lowest price negotiated;
-
In Italy, Hexvix® obtained reimbursement at the national
level, and as a result, experienced a 13.0% official price cut in
February 2014.
In the Other European countries:
-
In Belgium, a modulated price decrease of 1.95% on reimbursed products
has been applicable since the implementation of the Inami tax on 1st
April 2013;
-
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. The application of
international reference pricing led to price decreases on NutropinAq®
and to price increases on Somatuline®, Dysport®,
and Decapeptyl® as of 1st April 2014;
-
In Finland, a general price cut of 5.0% was applied on all drugs as of
1st February 2013;
-
In Sweden, since January 2014, products that have been marketed for
more than 15 years (i.e. Decapeptyl®) are subject to a
mandatory price cut of 7.5%;
-
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 Portugal, new measures published in 2013 call 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, a new price revision impacting the majority of specialty
care products commercialized by Ipsen occurred in February 2014.
Decapeptyl® is not concerned by the price cuts but patient
co-payment increased significantly. Finally, since 1st
April 2014, the Ministry of Health 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 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 Estonia, the price of Decapeptyl® 1M was reduced after
implementation of the international reference price;
-
In Czech Republic, the VAT on drugs has increased from 14.0% to 15.0%
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 European
Union). Moreover, since January 2013, Growth Hormones are no longer
considered a hospital product and hence 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 European Union. A new price revision associated with
the international reference price is ongoing with a publication
anticipated in October 2014;
-
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 as of 1st January 2013
and, thereafter, to a general price decrease by the industry as a way
of compensating. A price revision has been applicable since 1st
January 2014 affecting Decapeptyl® and Somatuline®;
-
In Romania, whereas prices are generally revised annually in March,
the Ministry of Health has decided to maintain a price freeze until
the final methodology for determining prices has been validated;
-
In Switzerland, Dysport® was impacted by a price cut in
December 2013 following the application of the international reference
price (which takes place every three years).
In the Rest of the World:
-
In China, the willingness to implement an international reference
pricing system, announced in 2012, has not advanced because
authorities are prioritizing price control of products included on the
Essential Drug List (EDL). In this context, Tanakan®, which
is included on the "low price product" list - about 80% of the EDL -
might experience a 10.0% cut on its hospital bidding price. The
bidding price being identical to that invoiced to patients, the
government has committed to compensate hospitals using these low price
products;
-
In Colombia, the "National Committee of Drug Prices" (Comisión
Nacional de Precios de Medicamentos) imposed a price cut on 364
medicines in December 2013, including that of Dysport®. In
August 2013, the prices of 195 medicines had already been regulated,
including that of Somatuline®;
-
In Ukraine, authorities introduced a 7.0% VAT on drugs as of 1st
April 2014 as part of an "anti-crisis" law. The measure, which was
announced and voted within a couple of days, triggered a sudden stop
in the availability of certain drugs in the country. Moreover, in
terms of referencing, there are discussions to expand the current
basket of reference countries (Bulgaria, Moldavia, Poland, Czech
Republic, Slovakia) to three other countries (Latvia, Hungary and
Serbia) on certain classes of drugs as a pilot scheme;
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 2014 and beyond
In the Major Western European countries:
-
In France, the social security budget act for 2014 (PLFSS) introduced,
for the first time, the possibility for the pharmacist to substitute
biotechnology products by biosimilars, except when the physician
forbids it on the prescription. This rule has not yet been enacted and
must be subject to a decree. It could potentially have an impact on
NutropinAq®.
In the Other European countries:
-
In Portugal, the Ministry of Health is pressing the local
pharmaceutical association (APIFARMA) in the context of negotiations
with the industry on the spending exceeding a certain threshold in
2014. For the 2015 government budget, the Ministry of Finance is
thinking of introducing an extraordinary tax with a particular
attention to pharmaceutical industry profits. Moreover, the new 3.0%
tax on all hospital business announced late 2013, to become effective
in 2014, has not been introduced;
-
In Greece, the €2.44 billion claw-back as of end 2013 has not been
readjusted by the Ministry of Health as initially anticipated. Health
authorities are aiming at €2 billion for 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 Slovakia, as of 1st March 2014, a price decrease based
on the average of the 3 lowest prices in the 28 countries of the
European Union will apply to several Ipsen products.
In the Rest of the World:
-
In Algeria, Ipsen had to renew the Marketing Authorizations for all
its Primary Care products before the end of 2013. This process could
lead to price revisions in the first semester of 2014. Moreover, the
list of reference prices edited in October 2013 has not yet triggered
price decreases. The risk lays on Decapeptyl®, which price
is likely to be aligned with the least expensive molecule;
-
In Morocco, government announced reductions of the public and hospital
prices of about 5,000 products belonging to different classes
(hypertension, anti-infective agents, migraine, etc.) in January 2014.
Although the impact on public prices was limited (1.0%), the measure
affected the hospital sector with average decreases of 5.0% to 6.0%.
This situation penalizes all pharmaceutical companies, notably foreign
ones, in a country where overall margins are already low;
-
In China, regulatory authorities are strongly encouraging innovations
regarding the management of the Essential Drug List. As such, in
February 2014, the Guangdong province (110 million inhabitants)
pioneered in the launch of an online province-wide tender platform. An
average price decrease of 9.0% was reported for products competing in
the tenders;
-
Turkey is thinking of introducing a flexible price system in 2014. The
exact content is not yet known but measures such as not including
countries under Troïka (countries where policies are imposed by the
European Commission, the European Central Bank and the International
Monetary Fund), an update of foreign exchange rates and a price
increase for products under shortage are considered;
-
In Brazil, products with no generics on the market will benefit from a
1% price increase in 2014.
Comparison of consolidated sales for the first quarters of 2014 and
2013
Sales by geographical area
Note: Unless stated otherwise, all variations in sales are stated
excluding foreign exchange impacts by restating the Q1 2013 sales with
the Q1 2014 exchange rates.
Group sales by geographical area in the first quarters of 2014 and 2013
were as follows:
|
|
1st Quarter
|
|
|
|
|
|
|
|
(in million euros)
|
|
2014
|
|
2013
|
|
% Change
|
|
% Change at constant currency
|
|
|
|
|
|
|
|
|
|
France
|
|
54.3
|
|
58.6
|
|
-7.3%
|
|
-7.3%
|
United Kingdom
|
|
13.8
|
|
13.2
|
|
4.9%
|
|
1.9%
|
Spain
|
|
14.6
|
|
14.4
|
|
1.2%
|
|
1.2%
|
Germany
|
|
24.3
|
|
20.5
|
|
18.5%
|
|
18.5%
|
Italy
|
|
22.2
|
|
20.9
|
|
6.3%
|
|
6.3%
|
Major Western European countries
|
|
129.3
|
|
127.6
|
|
1.3%
|
|
1.0%
|
|
|
|
|
|
|
|
|
|
Eastern Europe
|
|
44.2
|
|
46.0
|
|
-3.8%
|
|
4.0%
|
Others Europe
|
|
37.4
|
|
35.8
|
|
4.5%
|
|
5.1%
|
Other European Countries
|
|
81.6
|
|
81.7
|
|
-0.2%
|
|
4.5%
|
|
|
|
|
|
|
|
|
|
North America
|
|
14.3
|
|
17.3
|
|
-17.0%
|
|
-14.0%
|
Asia
|
|
40.3
|
|
39.4
|
|
2.4%
|
|
4.4%
|
Other countries in the rest of the world
|
|
40.5
|
|
40.7
|
|
-0.6%
|
|
7.8%
|
Rest of the World
|
|
80.8
|
|
80.1
|
|
0.9%
|
|
6.1%
|
|
|
|
|
|
|
|
|
|
Group Sales
|
|
305.9
|
|
306.6
|
|
-0.2%
|
|
2.4%
|
Of which: Total Drug Sales
|
|
301.9
|
|
297.3
|
|
1.5%
|
|
4.3%
|
Drug-related Sales *
|
|
4.1
|
|
9.3
|
|
-56.3%
|
|
-56.4%
|
* Active ingredients and raw materials
In the first quarter 2014, sales generated in the Major Western
European countries amounted to €129.3 million, up 1.0% year-on-year.
The dynamic growth of specialty care products was partially offset by
the decline of French primary care sales. Sales in the Major Western
European countries represented 42.2% of total Group sales in the first
quarter 2014, compared to 41.6% the previous year.
France - In the first quarter 2014, sales reached €54.3 million,
down 7.3% year-on-year, affected by the decline of primary care sales.
Sales of Smecta® decreased over the period, penalized by the
7.5% price decrease applied as of 1st January 2014 and a
lower level of gastroenteritis epidemic than last year. Sales of Tanakan®
were impacted by an unfavorable comparison base associated with the
launch of a second "me-too" product in March 2013, while sales of Forlax®
suffered from generics competition. Sales of specialty care products,
stable over the period, were driven by the sustained growth of Somatuline®
and NutropinAq® sales, offset by the decrease in
Decapeptyl® sales, notably associated with inventory
reductions in anticipation of a price decrease applied as of 1st
April 2014. 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 19.1% the previous year.
United Kingdom - In the first quarter 2014, sales reached €13.8
million, up 1.9% year-on-year, fueled by the volume growth of Somatuline®,
which market share increased six points since September 2013, and of
Decapeptyl®. In the first quarter 2014, the United Kingdom
represented 4.5% of total Group sales, compared to 4.3% the previous
year.
Spain - In the first quarter 2014, sales reached €14.6 million,
up 1.2% year-on-year, driven by the robust growth of Somatuline®
sales. In the first quarter 2014, sales in Spain represented 4.8% of
total Group sales, compared to 4.7% the previous year.
Germany - In the first quarter 2014, sales reached €24.3 million,
up 18.5% year-on-year, driven by strong volume growth of Somatuline®
and Hexvix®. Growth benefited from the favorable impact
associated with the reduction (from 16% to 7%) in mandatory rebates on
prescription drug sales. Restated from this element, sales grew 10.1%.
Over the period, sales in Germany represented 7.9% of total Group sales,
compared to 6.7% a year earlier.
Italy - In the first quarter 2014, sales reached €22.2 million,
up 6.3% year-on-year, marked by the strong growth of Somatuline®
and by a favorable effect arising from a change in the distribution
model of Forlax®. Indeed, the affiliate had recorded no Forlax®
sales in the first quarter 2013 due to this change in distribution
model. Restated for this base effect, sales were up 3.0%. In the first
quarter 2014, sales in Italy represented 7.3% of total Group sales,
compared to 6.8% the previous year.
In the first quarter 2014, sales generated in the Other European
countries reached €81.6 million, up 4.5% year-on-year, penalized 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 were up 10.2%. Moreover, sales were driven
by solid volume growth in Russia, where Dysport® continues to
penetrate the aesthetics and therapeutics markets and where Tanakan®
records strong growth, the supply of Dysport® for aesthetic
use to Galderma, and the solid performance of the Netherlands and the
Czech Republic. Sales were penalized by the consequences of the
political crisis ongoing in Ukraine. In the first quarter 2014, sales in
this region represented 26.7% of consolidated Group sales, a stable
ratio year-on-year.
In the first quarter 2014, sales generated in North America
reached €14.3 million, down 14.0% year-on-year, mainly impacted by the
Increlex® supply interruption that occurred in mid-June 2013.
Restated for the Increlex® supply interruption, sales were up
13.8% year-on-year, driven by the solid volume and value growth of
Somatuline®, and by the solid performance of Dysport®
in therapeutics and aesthetics through the product supply to Valeant.
Sales in North America represented 4.7% of consolidated Group sales,
compared to 5.6% a year earlier.
In the first quarter 2014, sales generated in the Rest of the World
reached €80.8 million, up 6.1% year-on-year. Performance was affected by
a non-recurring effect in Vietnam, where orders had been anticipated in
the first quarter 2013 before the expiry of import licenses for certain
primary care products. Restated for this effect, sales were up 8.5%,
driven by strong volume growth in China (notably Decapeptyl® and
Smecta®), the Middle East and Brazil where Dysport®
sales recorded good performance in aesthetics and therapeutics. In the
first quarter 2014, sales in the Rest of the World accounted for 26.4%
of total consolidated Group sales, compared to 26.1% the previous year.
1 In accordance with the norm IFRS11 « Partnerships »
applicable since 1st January 2014 on the accounting treatment of joint
ventures
Sales by therapeutic area and by product
The following table shows sales by therapeutic area and by product for
the first quarters of 2014 and 2013:
|
|
1st Quarter
|
|
|
|
|
|
|
|
|
|
(in million euros)
|
|
2014
|
|
2013
|
|
% Change
|
|
% Change at constant currency
|
|
|
|
|
|
|
|
|
|
Uro-oncology
|
|
78.2
|
|
74.3
|
|
5.4%
|
|
6.1%
|
of which Hexvix®
|
|
4.4
|
|
4.0
|
|
11.0%
|
|
10.5%
|
of which Decapeptyl®
|
|
73.8
|
|
70.2
|
|
5.0%
|
|
5.9%
|
Endocrinology
|
|
86.2
|
|
81.9
|
|
5.4%
|
|
6.9%
|
of which Somatuline®
|
|
68.5
|
|
61.5
|
|
11.3%
|
|
13.0%
|
of which NutropinAq®
|
|
15.8
|
|
14.1
|
|
12.4%
|
|
13.0%
|
of which Increlex®
|
|
2.0
|
|
6.3
|
|
-68.6%
|
|
-67.8%
|
Neurology
|
|
60.8
|
|
60.8
|
|
-0.1%
|
|
6.3%
|
of which Dysport®
|
|
60.8
|
|
60.8
|
|
-0.1%
|
|
6.3%
|
Specialty Care
|
|
225.3
|
|
217.0
|
|
3.8%
|
|
6.4%
|
|
|
|
|
|
|
|
|
|
Gastroenterology
|
|
51.9
|
|
53.7
|
|
-3.3%
|
|
-0.8%
|
of which Smecta®
|
|
30.2
|
|
29.7
|
|
2.0%
|
|
4.1%
|
of which Forlax®
|
|
8.4
|
|
8.9
|
|
-5.7%
|
|
-4.9%
|
Cognitive Disorders
|
|
16.3
|
|
17.4
|
|
-6.6%
|
|
-0.4%
|
of which Tanakan®
|
|
16.3
|
|
17.4
|
|
-6.6%
|
|
-0.4%
|
Cardiovascular
|
|
5.5
|
|
6.2
|
|
-10.8%
|
|
-10.4%
|
of which Nisis® & Nisisco®
|
|
1.7
|
|
2.0
|
|
-12.3%
|
|
-12.3%
|
of which Ginkor®
|
|
3.6
|
|
4.2
|
|
-14.1%
|
|
-13.6%
|
Other Primary Care
|
|
2.9
|
|
3.1
|
|
-6.2%
|
|
-5.9%
|
of which Adrovance®
|
|
2.3
|
|
2.6
|
|
-10.3%
|
|
-10.3%
|
Primary Care
|
|
76.6
|
|
80.4
|
|
-4,7%
|
|
-1.7%
|
|
|
|
|
|
|
|
|
|
Total Drug Sales
|
|
301.9
|
|
297.3
|
|
1.5%
|
|
4.3%
|
Drug-related Sales*
|
|
4.1
|
|
9.3
|
|
-56.3%
|
|
-56.4%
|
Group Sales
|
|
305.9
|
|
306.6
|
|
-0.2%
|
|
2.4%
|
* Active ingredients and raw materials
In the first quarter 2014, sales of Specialty Care products
reached €225.3 million, up 6.4% year-on-year. Sales in Uro-oncology,
Endocrinology, and Neurology grew by respectively 6.1%, 6.9% and 6.3%
year-on-year. In the first quarter 2014, the relative weight of
specialty care products continued to increase to reach 73.6% of total
Group sales, compared to 70.8% the previous year.
In Uro-oncology, sales of Decapeptyl®
reached €73.8 million in the first quarter 2014, up 5.9% year-on-year.
This performance took place in the context of a strained environment in
Europe, negatively impacted by a contracting pharmaceutical market, more
frequent use of co-payment in Southern Europe and a slowdown in the
growth of Eastern European countries. Sales in Ukraine were penalized by
the ongoing political situation. Moreover, sales in France suffered from
inventory reductions in anticipation of the 4.0% price decrease applied
as of 1st April 2014. In China, double-digit growth resumed
in the first quarter 2014 after a year 2013 affected by a strained
competitive environment and the disruption of hospital market promotion.
In addition, sales in the Middle East posted solid growth. In the first
quarter 2014, sales of Hexvix® amounted to €4.4
million, mostly generated in Germany. Over the period, sales in
Uro-oncology represented 25.6% of total Group sales, compared to 24.2%
the previous year.
In Endocrinology, sales continued to progress to reach €86.2
million in the first quarter 2014, up 6.9% year-on-year, representing
28.2% of total Group sales, compared to 26.7% the previous year.
Somatuline® - In the first quarter 2014, sales
reached €68.5 million, up 13.0% year-on-year, driven by strong volume
and value growth in the United States and by a solid performance in
Germany, where strong volume growth was accompanied by a reduction (from
16% to 7%) in mandatory rebates on prescription drug sales. The product
also recorded positive momentum in the Netherlands, Italy and Denmark.
NutropinAq® - In the first quarter 2014, sales
reached €15.8 million, up 13.0%, driven by good performance in Germany,
France and Italy.
Increlex® - In the first quarter 2014, sales
reached €2.0 million, down 67.8%, affected by the shortage situation
outstanding since mid-June 2013 in the United States and since August
2013 in Europe. Supply resumed in Europe in early 2014.
In Neurology, Dysport® sales reached
€60.8 million in the first quarter 2014, up 6.3% year-on-year. Growth
was mainly driven by the supply of Dysport® for aesthetic use
to Galderma and by solid performance in Brazil and Russia for both the
therapeutics and aesthetics segments. Growth was affected by the
consequences of the political crisis in Ukraine. Dysport®
sales represented 19.9% of total Group sales, a stable ratio
year-on-year.
In the first quarter 2014, sales of Primary Care products
amounted to €76.6 million, down 1.7% year-on-year. Sales recorded solid
performance in China, Russia, and Algeria. Sales in France declined by
15.3% year-on-year, affected by the launch of a competitive product to
Tanakan® in March 2013, the 7.5% price cut on Smecta®
implemented as of 1st January 2014, and the negative
consequences arising from the reinforcement of the "Tiers-Payant1"
regulation. In the first quarter 2014, primary care sales represented
25.0% of Group consolidated sales, compared to 26.2% the previous year.
Primary care sales in France accounted for 31.1% of the Group's total
primary care sales, compared to 35.0% the previous year.
In Gastroenterology, sales reached €51.9 million, down 0.8%
year-on-year, penalized by a strong first quarter 2013, when orders had
been anticipated before the expiry of import licenses for certain
primary care products.
Smecta® - In the first quarter 2014, sales
reached €30.2 million, up 4.1% year-on-year, driven by strong growth in
China and Algeria, partially offset by the performance in France,
affected by a low level of gastroenteritis epidemic and the 7.5% price
cut implemented as of 1st January 2014. Smecta®
sales represented 9.9% of total Group sales over the period, compared to
9.7% the previous year.
Forlax® - In the first quarter 2014, sales
reached €8.4 million, down 4.9% year-on-year, mainly affected by the
reinforcement of the "Tiers-Payant1" regulation in France. In
the first quarter 2014, France represented 46.7% of total product sales,
compared to 60.8% the previous year.
In the cognitive disorders area, sales of Tanakan®
in the first quarter 2014 reached €16.3 million euros, down 0.4%
year-on-year, penalized by the launch of a second "me-too" product in
France in March 2013 and by a change in the commercial model for Spain,
where the product is now distributed by a partner. The product recorded
good performance in Russia. In the first quarter 2014, 24.1% of Tanakan®
sales were achieved in France, compared to 25.9% the previous year.
In the cardiovascular area, sales amounted to €5.5 million euros
in the first quarter 2014, down 10.4% year-on-year, mainly impacted by
the decline of Nisis® / Nisisco®
and Ginkor Fort® sales.
Sales of Other primary care products reached €2.9 million in the
first quarter 2014, down 5.9% year-on-year, mainly impacted by the 10.3%
decline in Adrovance® sales.
1 With the "Tiers-Payant" regulation, the patient now pays
upfront for a branded drug and is reimbursed only later on
In the first quarter 2014, drug-related sales (active ingredients and
raw materials) reached €4.1 million, down 56.4% year-on-year.
Performance was penalized by an unfavourable effect associated with the
change in methodology for the consolidation of sales of the Swiss
company Linnea. Indeed, sales of active ingredients and raw materials
made by Linnea, partner on which Ipsen and the Schwabe Group exercise
joint control, will from now on be consolidated under the equity method
of accounting2. Restated for this base effect, sales were
down 23.2%.
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 ]
|