Regulatory News:
Ipsen (Paris:IPN) reported today its sales for the first quarter 2008.
First quarter 2008 unaudited IFRS consolidated sales
= = = = = = = = = = =
(in million euros)
2008
2007
% change
- - - - - -
- - - - - -
Underlying Group sales (1)
236.5
218.3
+8.4%
- - - - - -
- - - - - -
SALES BY REGION
- - - - - -
Major Western European countries
134.8
138.8
(2.9%)(2)
- - - - - -
Other European countries
60.1
52.7
+14.2%
- - - - - -
Rest of the world
43.9
35.2
+24.8%
- - - - - -
Group Sales
238.9
226.7
+5.4%
- - - - - -
- - - - - -
SALES BY PRODUCT
- - - - - -
Specialist Care
132.9
121.2
+9.7%
- - - - - -
Primary care
94.5
96.8
(2.4%)(2)
- - - - - -
Total Drug Sales
227.4
218.0
+4.3%
- - - - - -
Drug-related Sales
11.5
8.7
+31.4%
- - - - - -
Group Sales
238.9
226.7
+5.4%
- - - - - -
NOTE 1. "underlying Group sales" is defined as Group sales at constant currency, and excluding Ginkor Fort® sales which was sold to GTF Group as of 1 January 2008.
NOTE 2. 2007 sales include in-market sales of Ginkor Fort® wherehas 2008 mostly includes sales of the product to GTF.
Consolidated Group sales reached ?238.9
million, up 5.4% year-on-year. Underlying Group sales (excluding Ginkor
Fort® sales, sold to GTF Group on 1 January 2008, and at constant currency)
grew by a strong 8.4% year-on-year despite price pressure, which
represented (0.3) points of growth, or ?(0.6)
million. Therefore, in volume, underlying Group sales grew by a solid
8.7% year-on year.
This increase was fuelled notably by the strong growth in endocrinology
and neuromuscular disorders franchises, up 15.7% and 24.9% respectively
over the period and by the strong performance of gastroenterology
products, up 9.6% year-on-year.
Sales generated in the Major Western European countries amounted to ?134.8
million, down 2.9% year-on-year. Excluding the sales of Ginkor Fort®
sales in this region were flat year-on-year, due to negative price
impacts, notably on Decapeptyl® in Italy and to a decrease in Tanakan® sales in France. Sales in Major Western European countries
represented 56.4% of Group sales compared with 61.2% a year earlier.
Sales generated in the Other European countries reached ?60.1
million, up 14.2% year-on-year, mainly driven by strong growth of Tanakan® and Dysport® in
Russia and Decapeptyl®
Dysport®, Tanakan® and Smecta® in
Eastern European countries. Sales in Other European countries
represented 25.2% of Group sales, against 23.2% a year earlier.
Sales generated in the Rest of the World reached ?43.9
million, up 24.8% year-on-year thanks to the growth of Decapeptyl® and Forlax® in
China, Dysport® in
Brazil, and Somatuline® in the United States. Sales in Rest of the World represented 18.4% of
Group sales, against 15.5% a year earlier.
About Ipsen
Ipsen is an innovation-driven international specialty pharmaceutical
group with over 20 products on the market and a total worldwide staff of
nearly 4,000. Its development strategy is based on a combination of
specialty products, which are growth drivers, in targeted therapeutic
areas (oncology, endocrinology and neuromuscular disorders), and primary
care products which contribute significantly to its research financing.
The location of its four Research & Development centres (Paris, Boston
Barcelona, London) and its peptide and protein engineering platform give
the Group a competitive edge in gaining access to leading university
research teams and highly qualified personnel. More than 700 people in
R&D are dedicated to the discovery and development of innovative drugs
for patient care.This strategy is also supported by an active policy of
partnerships. In 2007, Research and Development expenditure was about ?185
million, in excess of 20% of consolidated sales, which amounted to ?920.5
million while total revenues amounted to ?993.8
million. Ipsen´s shares are traded on
Segment A of Eurolist by EuronextTM (stock
code: IPN, ISIN code: FR0010259150). Ipsen´s
shares are eligible to the "Service de Règlement
Différé" ("SRD") and the
Group is part of the SBF 120 index. For more information on Ipsen, visit
our website at www.ipsen.com.
Ipsen Forward-looking statements
The forward-looking statements and targets contained herein are based on
Ipsen´s management´s 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. The targets contained herein were prepared without
taking into account external growth assumptions, which may alter the
parameters. These targets are based on data and assumptions regarded as
reasonable by the Group and depend on conditions or facts likely to
happen in the future, and not exclusively on historical data. Actual
results may depart significantly from the targets given the occurrence
of certain risks and uncertainties. The Group does not commit nor gives
any guarantee that it will meet the targets mentioned above. Moreover
the Research and Development process involves several stages at each of
which there is a substantial risk that the Group will fail to achieve
its objectives and be forced to abandon its efforts in respect of 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. Moreover, the
targets described in this document were prepared without taking into
account external growth assumptions, which may alter these parameters.
These targets 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. The Group does not commit nor gives
any guarantee that it will meet the targets mentioned above. Ipsen
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. Ipsen´s business is subject to the risk
factors outlined in its information documents filed with the French Autorité des Marchés Financiers.
APPENDIX
Risk factors
The Group carries on business 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 Ipsen´s
2006 Registration Document available on its website (www.ipsen.com).
The Group is dependent on the setting of prices for medicines and is
vulnerable to the possible withdrawal of certain products from the
list of reimbursable products by governments or by the relevant
regulatory authorities in the countries where it does business.
A number of products that the Group is developing are still at the
very first stages of development and the Group cannot be certain that
these products will be approved by the competent regulatory
authorities and that they will be successfully marketed.
The Group depends on third parties to develop and market some of its
products, which generates substantial royalties for the Group, but
these third parties could behave in ways which cause damage to the
Group´s business.
The Group´s competitors could infringe its
patents or circumvent them through design innovations. In order to
prevent infringements, the Group could engage in patent litigation
which is costly and time-consuming. It is difficult to monitor the
unauthorised use of the Group´s
intellectual property rights and it could find itself unable to
prevent the unlawful appropriation of its intellectual property rights.
The Group must deal with or may have to deal with competition (i) from
generic products, (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
authorisation 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, in particular Tanakan® and (iii) products sold for unauthorised uses when the protection
afforded by patent law to the Group´s
products and those of its competitors expires. Such a situation could
result in the Group losing market share which could affect its current
level of growth in sales or profitability. To avoid such situations or
to reduce their impact, the Group could bring legal actions against
the counterfeiters in order to protect its rights.
Major developments in the period under review
During the first quarter 2008, the major developments included:
On March 17, 2008 "“ Medicis and Ipsen
announced that Ipsen has submitted a Biologics License Application ("BLA")
for the botulinum toxin type A, Reloxin®
in aesthetic indications (glabellar lines) to the U.S. Food and Drug
Administration´s ("FDA")
Division of Dermatology and Dental Products, within the Center for
Drug Evaluation and Research.
On February 25, 2008 "“ Ipsen announced
that GTx Inc., from which it licensed the European rights for Acapodene® (toremifene citrate 80 mg) in September 2006, presented the results of
the first phase III study evaluating the efficacy and safety of
toremifene citrate 80mg daily, on multiple side effects of androgen
deprivation therapy (ADT) in advanced prostate cancer patients. Ipsen
also announced its intention to submit the toremifene citrate 80 mg
dossier in Europe before year-end 2008.
On February 21, 2008 "“ Ipsen announced
that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMEA) provided a positive opinion for
Adenuric® (febuxostat) 80 mg and 120 mg
tablets for the treatment of chronic hyperuricaemia in gout and
recommended it for marketing authorisation.
On February 12, 2008 "“ Ipsen announced
that its partner Debiopharm presented the results of a phase III study
with its new 6-month formulation of Decapeptyl®
a luteinizing hormone releasing hormone agonist (LHRHa) for the
treatment of advanced prostate cancer. The results presented showed
similar efficacy and safety to the already marketed 1- and 3-month
formulations of triptorelin.
On January 31, 2008 "“ Ipsen announced that
the Food and Drug Administration (FDA) has accepted the filing of its
BLA for Dysport® in the United States to treat patients with cervical dystonia.
European governments continued to introduce various measures to reduce
public healthcare spending, which affected the Group´s
sales and earnings during 2008:
On 15 June 2007, a 10% price cut on Tanakan® in France as of 1 July 2007 was published in the Journal Officiel.
In the United Kingdom the Department of Health has approved list price
increases as of 1 June 2007 from 6.7 % to 9.6% for Dysport®
Somatuline® and
NutropinAq® thanks to over-delivery of savings to the Department due to
over-budget sales performance of Decapeptyl®.
Comparison of consolidated sales for the first quarters 2008 and 2007:
Sales by geographical region
Group sales by geographical region for the first quarter 2008 and 2007
were as follows:
= = = = = = = = = = =
(in thousand euros)
2008
2007
% change
- - - - - -
- - - - - -
France
75,759
84,793
(10.7%)
- - - - - -
Spain
14,706
14,010
5.0%
- - - - - -
Italy
18,043
18,558
(2.8%)
- - - - - -
Germany
16,085
11,685
37.7%
- - - - - -
United Kingdom
10,218
9,782
4.5%
- - - - - -
Major Western European countries
134,811
138,828
(2.9%)
- - - - - -
- - - - - -
Other European countries
60,123
52,657
14.2%
- - - - - -
- - - - - -
Asia
24,362
20,866
16.8%
- - - - - -
North America
1,126
ns
ns
- - - - - -
Other countries in the rest of the world
18,442
14,342
28.6%
- - - - - -
Rest of the world
43,929
35,208
24.8%
- - - - - -
- - - - - -
Group Sales
238,864
226,693
5.4%
- - - - - -
For the first quarter 2008, sales generated in the Major Western
European countries amounted to ?134.8
million, down 2.9% year-on-year (first quarter 2007, ?138.8
million). Excluding the sales of Ginkor Fort®
sales were flat year-on-year, due to negative price impacts, notably on
Decapeptyl® in
Italy and to a decrease in Tanakan® sales in France following a 10% price cut implemented on July 1, 2007
and an increased competitive environment. Sales in this region
represented 56.4% of total sales compared with 61.2% a year earlier.
France "“ For the first quarter 2008
sales reached ?75.8 million, down 10.7%
year-on-year (first quarter 2007, ?84.8
million), strongly impacted by the price cut on Tanakan® and by the transfer of the marketing authorisations of Ginkor
Fort® for France
Monaco and Andorra to GTF group as of 1 January 2008. These negative
impacts did offset the good performances of all the other products
notably Nisis® &
Nisisco®
NutropinAq®
Dysport®
Somatuline® and Smecta®.
The weight of France in the Group´s
consolidated sales continued to decline, representing 31.7% of total
Group sales against 37.4% a year earlier.
Spain "“ For the first quarter 2008
sales reached ?14.7 million, up 5.0%
year-on-year (first quarter 2007, ?14.0
million) fuelled by the double digit growth of Somatuline® and NutropinAq®
despite an increased competitive environment for Decapeptyl®.
Italy "“ For the first quarter 2008
sales reached ?18.0 million, down 2.8%
year-on-year (first quarter 2007, ?18.6
million), despite the negative price pressure on Decapeptyl®.
Sales in Italy represented 7.6% of total Group sales against 8.2% a year
earlier.
Germany "“ For the first quarter 2008
sales reached ?16.1 million, up 37.7%
year-on-year (first quarter 2007, ?11.7
million), thanks to the strong growth of Decapeptyl®
doubling sales year-on-year, as well as the double digit growth of
Dysport® and Somatuline® .
United Kingdom "“ For the first
quarter 2008, sales reached ?10.2 million
up 4.5% year-on-year (first quarter 2007, ?9.8
million) or 17.9% in local currency with all products displaying solid
volume growth partly offset by a negative foreign exchange impact of ?1.1
million.
For the first quarter 2008, sales generated in the Other European
countries reached ?60.1 million, up
14.2% year-on-year (first quarter 2007, ?52.7
million) mainly driven by strong volume growth of Tanakan® and Dysport® in
Russia and Decapeptyl®
Dysport®, Tanakan® and Smecta® in
Eastern European countries. Over the same period, sales in this region
represented 25.2% of total consolidated Group sales, against 23.2% a
year earlier.
For the first quarter 2008, sales generated in the Rest of the World reached ?43.9 million, up 24.8% year-on-year
(first quarter 2007, ?35.2 million) thanks
to the volume growth of Decapeptyl® and Forlax® in
China, Dysport® in
Brazil, and Somatuline® in the United States. Sales in this region represented 18.4% of total
consolidated Group sales, against 15.5% a year earlier.
Sales by therapeutic area and by product
The following table shows sales by products, regrouped by therapeutic
areas for the first quarter 2008 and 2007:
= = = = = = = = = = =
(in thousand euros)
2008
2007
% change
- - - - - -
- - - - - -
Oncology
60,800
61,145
(0.6%)
- - - - - -
of which
Decapeptyl® (1)
60,798
61,135
(0.6%)
- - - - - -
Endocrinology
36,463
31,520
15.7%
- - - - - -
of which
Somatuline® (1)
28,402
25,217
12.6%
- - - - - -
NutropinAq® (1)
7,196
5,742
25.3%
- - - - - -
Increlex® (1)
270
ns
- - - - - -
Neuromuscular disorders
35,629
28,520
24.9%
- - - - - -
of which
Dysport® (1)
35,629
28,520
24.9%
- - - - - -
Specialist Care
132,892
121,184
9.7%
- - - - - -
- - - - - -
Gastroenterology
46,621
42,537
9.6%
- - - - - -
of which
Smecta®
24,573
22,863
7.5%
- - - - - -
Forlax®
13,486
11,897
13.4%
- - - - - -
Cognitive disorders
26,569
31,023
(14.4%)
- - - - - -
of which
Tanakan®
26,569
31,023
(14.4%)
- - - - - -
Cardiovascular
18,131
22,233
(18.5%)
- - - - - -
of which
Nisis® & Nisisco®
12,625
11,801
7.0%
- - - - - -
Ginkor Fort®
4,423
8,398
(47.3%)
- - - - - -
Other Primary Care products
3,158
971
ns
- - - - - -
of which
Adrovanceâ„¢
1,971
ns
- - - - - -
Primary care
94,479
96,764
(2.4%)
- - - - - -
- - - - - -
Total Drug sales
227,371
217,949
4.3%
- - - - - -
Drug-related sales
11,493
8,744
31.4%
- - - - - -
Group Sales
238,864
226,693
5.4%
- - - - - -
(1) Peptide- or protein-based products
- - - - - -
For the first quarter 2008, sales of specialist care products reached
?132.9 million, up 9.7% year-on-year (first
quarter 2007, ?121.2 million), representing
55.6% of the Group´s consolidated sales
against 53.5% a year earlier.
In the oncology franchise, sales of Decapeptyl® reached ?60.8 million for the
first quarter 2008, down 0.6% year-on-year, compared with a strong
first quarter 2007, which benefited from sustained sales in the Middle
East. Solid growth in China, Germany and in the United Kingdom was
offset by a slow-down in France and the Middle East.
In endocrinology, sales reached ?36.5
million for the first quarter 2008, up 15.7% year-on-year (first
quarter 2007, ?31.5 million), driven by
the strong performance of Somatuline® in all markets.
Somatuline® -- For the first quarter 2008, sales reached ?28.4
million, up 12.6% year-on-year (first quarter 2007, ?25.2
million) fuelled by strong volume growth in Germany, Spain, Nordic
countries and Belgium, where the product continued to gain market share
and by the launch of Somatuline® Depot in the United States, as the Group books the sales of the product
to Tercica Inc..
NutropinAq® -- For the first quarter 2008, sales reached ?7.2
million, up 25.3% year-on-year (first quarter 2007, ?5.7
million) driven by strong performance in all countries, especially in
France, Italy, Spain and Romania.
Increlex® "“ For the first quarter 2008, sales of
Increlex® reached ?0.3 million. The product has has
been launched in Germany and the United Kingdom and is being rolled out
in Italy and Spain.
In the neuromuscular disorders franchise, Dysport® sales reached ?35.6 million, up 24.9%
year-on-year (first quarter 2007, ?28.5
million), fuelled by strong growth in Russia, Germany and in the
United Kingdom along with strong sales in Brazil compared to a low base"“line
in the first quarter of last year.
In the first quarter 2008, sales of Primary Care products reached ?94.5
million, down 2.4% year-on-year (first quarter 2007, ?96.8
million), negatively impacted by slower sales in France resulting
notably from the the price cuts enforced on Tanakan® in July 2007 and from the divestment of Ginkor Fort® in January 2008. Sales of Primary care drugs outside of the Major
Western European countries continued to perform well, notably
gastroenterology products in China. Primary Care products represented
39.6% of the Group´s consolidated sales over
the period, against 42.7% a year earlier.
In gastroenterology, sales reached ?46.6
million, up 9.6% year-on-year (first quarter 2007, ?42.5
million).
Smecta® -- For the first quarter 2008, sales reached ?24.6
million, up 7.5% year-on-year (first quarter 2007, ?22.9
million), thanks to strong sales in Algeria, China and France, where a
new formulation was recently launched.
Forlax® -- For the first quarter 2008, sales reached ?13.5
million, up 13.4% year-on-year (first quarter 2007, ?11.9
million), with particularly strong sales growth in China, Italy and
Belgium. As a consequence, the relative weight of France in the overall
sales of the product, amounted to only 67.0% in the first quarter of
2008, from 76.5% a year ago.
In the cognitive disorders area, sales of Tanakan® for the first quarter of 2008 reached ?26.6
million, down 14.4% year-on-year (first quarter 2007, ?31.0
million) following the implementation of a 10% price reduction by the
French Comité Économique
des Produits de Santé on July 1, 2007.
The sales of Tanakan® were also negatively impacted by an increased
competitive environment in France, following the launch, mid 2007, of
a new product containing a Ginkgo biloba extract. Sales of Tanakan® in France represented only 50.1% of total product sales compared with
64.7% a year earlier as sales growth of the product outside of France
reached 21.2% over the period.
In the cardiovascular area, sales in the first quarter 2008
amounted to ?18.1 million, down 18.5%
year-on-year (first quarter 2007, ?22.2
million), mainly due to the divestment of Ginkor Fort® as of January 2008 to GTF.
Nisis® and Nisisco® -- For the first quarter 2008, sales reached ?12.6
million, up 7.0% year-on-year (first quarter 2007, ?11.8
million).
Ginkor Fort® -- For the first quarter 2008, sales amounted to ?4.4
million, down 47.3% year-on-year (first quarter 2007, ?8.4
million), reflecting the supply sales of the product to GTF and the
sound performance of Ginkor Fort® in an OTC setting.
Other primary care products sales reached ?3.2
million for the first quarter 2008, against ?1.0
million a year earlier, with sales of Adrovanceâ„¢ launched in France in April 2007 contributing to ?2.0
million during the first quarter 2008.
For the first quarter 2008, drug-related sales (active ingredients
and raw materials) were up 31.4% to ?11.5
million, notably due to seasonal strong sales of Ginkgo biloba extract
in Germany and other active ingredients in Switzerland (up ?0.4
million, 12.8%).
