Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven
biopharmaceutical group, today announced its sales for the first
quarter of 2019.
- Q1 2019 Group sales growth of 17.0% as
reported, or 15.8%1 at constant exchange rates and consolidation
scope driven by:
- Specialty Care sales growth of 17.6%1,
with continued strong momentum across all major products and
geographies
- Consumer Healthcare sales growth of
3.3%1
- Full Year 2019 guidance confirmed
following the completion of the acquisition of Clementia
Pharmaceuticals on 17 April:
- Group sales growth greater than 13.0%1
at constant exchange rates and consolidation scope. Based on the
current level of exchange rates, there is an expected +2.0% impact
from currencies.
- Core Operating Income margin around
30.0% of net sales (excluding incremental investments in pipeline
expansion initiatives)
First quarter 2019 unaudited IFRS consolidated
sales
(in million euros)
Q1 2019 Q1 2018
%
Change
% Change at constant currency
&consolidation scope1
Specialty Care 530.9 440.4 +20.5% +17.6% Consumer Healthcare
66.3 69.9 -5.2% +3.3%
Group Sales 597.2 510.3
+17.0% +15.8%
David Meek, Chief Executive Officer of Ipsen stated:
“With robust double-digit sales growth in the first quarter, Ipsen
is on track for another year of outstanding business execution. The
Specialty Care business continues to thrive across all major
products and geographies with volume and market share gains. We are
accelerating the ongoing transformation of Ipsen by executing on
our external innovation strategy to strengthen the R&D pipeline
with novel first and best-in-class assets.
“Notably, in the first quarter, we announced and completed the
acquisition of Clementia Pharmaceuticals, a company focused on the
treatment of rare and severely-disabling bone disorders.
Palovarotene is a largely de-risked near-term launch opportunity
with significant upside potential. Together, with our new
colleagues from Clementia, we will leverage our combined scientific
and development expertise to deliver new treatments to patients
with high unmet medical needs.”
_______________1 At constant exchange rates and reflecting a
change in the consolidation method for joint arrangements related
to the Consumer Healthcare Schwabe partnership. Year-on-year growth
excluding foreign exchange impact established by recalculating net
sales for the relevant period at the rate used for the previous
period.
Comparison of Consolidated Sales for the First Quarter 2019
and 2018:
All variations in sales are stated excluding foreign exchange
impacts, established by recalculating net sales for the relevant
period at the rates from the previous period.
Starting in 2019, the joint arrangements related to the Consumer
Healthcare Schwabe partnership is consolidated using the equity
method instead of consolidating in 2018 as joint operations under
IFRS 11. Group and Consumer Healthcare variations in sales
presented below are restated to exclude 2018 sales from the Schwabe
partnership.
Sales by therapeutic area and by product
1st Quarter
(in million euros)
2019
2018 % Variation
% Variation at constantcurrency
andconsolidation scope2
Oncology
420.7 337.3
24.7% 21.2% Somatuline® 235.5 195.7 20.4% 15.7%
Decapeptyl® 88.7 83.1 6.8% 6.4% Cabometyx® 53.9 28.2 91.2% 91.1%
Onivyde® 34.6 23.8 45.8% 35.3% Other Oncology 8.0 6.6 20.4% 20.1%
Neuroscience
94.3 85.0 10.9% 9.8%
Dysport® 93.8 84.4 11.1% 9.9% Rare Diseases
15.8 18.0
-12.3% -13.9% NutropinAq® 10.5 12.2 -13.6% -13.6%
Increlex® 5.3 5.9 -9.7% -14.7%
Specialty Care 530.9
440.4 20.5% 17.6% Smecta® 29.9 29.1 2.6% 2.0%
Tanakan® 9.4 7.8 20.6% 21.3% Forlax® 8.5 10.2 -17.1% -17.1%
Fortrans/Eziclen® 7.8 6.0 31.5% 31.6% Other Consumer Healthcare
10.7 10.9 -36.3% -2.3%
Consumer Healthcare 66.3
69.9 -5.2% 3.3% Group Sales
597.2 510.3 17.0%
15.8%
Group sales reached €597.2 million, up 15.8%2, driven by
Specialty Care sales growth 17.6%2 and Consumer Healthcare sales
growth of 3.3%2.
Specialty Care sales amounted to €530.9 million, up
17.6%2. Oncology and Neuroscience sales grew by 21.2% and 9.8%,
respectively, while Rare Diseases sales decreased by 13.9%. Over
the period, the relative weight of Specialty Care continued to
increase to reach 88.9% of total Group sales, compared to 86.3% in
2018.
In Oncology, sales reached €420.7 million, up 21.2%
year-on-year, driven by the continued strong performance of
Somatuline® as well as the contribution of Cabometyx® and Onivyde®.
Over the period, Oncology sales represented 70.5% of total Group
sales, compared to 66.1% in 2018.
_______________2 At constant exchange rates and reflecting a
change in the consolidation method for joint arrangements related
to the Consumer Healthcare Schwabe partnership. Year-on-year growth
excluding foreign exchange impact established by recalculating net
sales for the relevant period at the rate used for the previous
period.
Somatuline® – Sales reached
€235.5 million, up 15.7% year-on-year, driven by 22.7% growth in
North America primarily from volume growth and despite inventory
build at the end of 2018. There was also continued double-digit
growth in most European countries, notably in Germany, the UK,
Spain, Sweden and Italy.
Decapeptyl® – Sales reached
€88.7 million, up 6.4% year-on-year, positively impacted by good
volume growth across Europe, higher sales in the Middle East and in
China, partly offset by an importation delay in Algeria.
Cabometyx® – Sales reached
€53.9 million, up 91.1% year-on-year, driven by good performance in
all European countries, as well as launches in Asia and
Oceania.
Onivyde® – Sales reached €34.6
million, up 35.3% year on year, including steady growth in the U.S.
and a growing demand from Ipsen’s ex-U.S. partner.
In Neuroscience, sales of Dysport® reached
€93.8 million, up 9.9%, driven by the good performance in the U.S.
both in the therapeutics and aesthetics markets. Over the period,
Neuroscience sales represented 15.8% of total Group sales, compared
to 16.7% in 2018.
In Rare Diseases, sales of NutropinAq®
reached €10.5 million, down 13.6% year-on-year, impacted by lower
volumes across Europe. Sales of Increlex® reached
€5.3 million, down 14.7% year-on-year mainly due to lower volumes
in the U.S. Over the period, Rare Diseases sales represented 2.6%
of total Group sales, compared to 3.5% in 2018.
Consumer Healthcare sales reached €66.3 million, up
3.3%3, driven by the good performance in Russia and Eastern Europe
of Fortrans®/Eziclen® which was up 31.6% year-on-year; the 21.3%
growth of Tanakan® year-on-year, which benefitted from the low 2018
baseline in Vietnam due to license renewal. The growth of the first
quarter was also driven by the higher sales of Smecta®, up by 2.0%
year-on-year, with a good performance in Russia, France and China,
partly offset by some importation delay in Algeria. Over the
period, Consumer Healthcare sales represented 11.1% of total Group
sales, compared to 13.7% in 2018.
Sales by geographical area
1st Quarter
(in million euros)
2019 2018 % Variation
% Variation atconstant currencyand
consolidationscope3
France 82.0 68.2 20.3% 19.9% Germany 45.4 44.2
2.5% 18.2% Italy 29.8 26.2 13.4% 13.4% United Kingdom 25.2 22.5
11.7% 11.2% Spain 23.8 21.0 13.5% 13.5%
Major Western European
countries 206.1 182.2 13.1% 16.7%
Eastern Europe 47.8 42.5 12.5% 15.0% Other Europe 65.8 66.1 -0.6%
-0.3%
Other European Countries 113.5 108.6
4.5% 5.6% North America 179.2
133.5 34.2% 23.9% Asia 50.4 39.4 27.8% 24.6%
Other countries in the Rest of the world 47.9 46.6 3.0% 3.8%
Rest of the World 98.3 86.0 14.4%
13.5% Group Sales 597.2
510.3 17.0% 15.8%
Sales in Major Western European countries reached €206.1
million, up 16.7%3 year-on-year. Over the period, sales in Major
Western European countries represented 34.5%3 of total Group sales,
compared to 34.9% in 2018.
_______________3 At constant exchange rates and reflecting a
change in the consolidation method for joint arrangements related
to the Consumer Healthcare Schwabe partnership. Year-on-year growth
excluding foreign exchange impact established by recalculating net
sales for the relevant period at the rate used for the previous
period.
France – Sales reached €82.0 million,
up 19.9% year-on-year, driven by the continued Cabometyx® ramp-up,
sustained growth of Somatuline®, positive sales trends of
Decapeptyl® and Smecta® and the contribution of Prontalgine® and
Onivyde® sales to Ipsen’s new ex-U.S. partner since September
2018.
Germany – Sales reached €45.4 million,
up 18.2%4 year-on-year, driven by Cabometyx® and the strong
double-digit growth of Somatuline®.
Italy – Sales reached €29.8 million,
up 13.4% year-on-year, mainly driven by Cabometyx® and good
double-digit growth of Somatuline® and Decapeptyl®.
United Kingdom – Sales reached €25.2
million, up 11.2% year-on-year, driven by the strong performance of
Somatuline® and Cabometyx®.
Spain – Sales reached €23.8 million,
up 13.5% year-on-year, driven by the Cabometyx® contribution and
Somatuline® sales growth.
Sales in Other European countries reached €113.5 million,
up 5.6% year-on-year, driven by the launch of Cabometyx® in certain
countries and the strong growth of Somatuline®. Over the period,
sales in the region represented 19.0% of total Group sales,
compared to 21.3% in 2018.
Sales in North America reached €179.2 million, up 23.9%
year-on-year, driven by continued strong growth of Somatuline®, as
well as the Onivyde® contribution and the good performance of
Dysport®. Over the period, sales in North America represented 30.0%
of total Group sales, compared to 26.2% in 2018.
Sales in the Rest of the World reached €98.3 million, up
13.5% year-on-year, driven by Cabometyx® launches in some countries
as well as by good performance of Dysport® and Decapeptyl®, partly
offset by an importation delay in Algeria. Over the period, sales
in the Rest of the World represented 16.5% of total Group sales,
compared to 16.9% in 2018.
Conference call
Ipsen will host a conference call on Wednesday 24 April 2019 at
2:30 p.m. (Paris time, GMT+1). A conference call will take place
and a web conference (audio and slides) will be available at
www.ipsen.com. Participants should dial in to the call
approximately 5 to 10 minutes prior to its start. No reservation is
required to participate in the conference call.
Standard International: +44 (0) 2071-928-000France and
continental Europe: + 33 (0) 1 76 70 07 94UK: 08-445-718-892U.S.:
1-6315-107-495
Conference ID: 9846139
A recording will be available for 7 days on Ipsen’s website.
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group
focused on innovation and Specialty Care. The group develops and
commercializes innovative medicines in three key therapeutic areas
- Oncology, Neuroscience and Rare Diseases. Its commitment to
Oncology is exemplified through its growing portfolio of key
therapies for prostate cancer, neuroendocrine tumors, renal cell
carcinoma and pancreatic cancer. Ipsen also has a well-established
Consumer Healthcare business. With total sales over €2.2 billion in
2018, Ipsen sells more than 20 drugs in over 115 countries, with a
direct commercial presence in more than 30 countries. Ipsen's
R&D is focused on its innovative and differentiated
technological platforms located in the heart of the leading
biotechnological and life sciences hubs (Paris-Saclay, France;
Oxford, UK; Cambridge, US). The Group has about 5,700 employees
worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the
United States through a Sponsored Level I American Depositary
Receipt program (ADR: IPSEY). For more information on Ipsen, visit
www.ipsen.com.
_______________4 At constant exchange rates and reflecting a
change in the consolidation method for joint arrangements related
to the Consumer Healthcare Schwabe partnership. Year-on-year growth
excluding foreign exchange impact established by recalculating net
sales for the relevant period at the rate used for the previous
period.
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 favorable 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. The risks and uncertainties set out are not exhaustive
and the reader is advised to refer to the Group’s 2018 Registration
Document available on its website (www.ipsen.com).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190423005945/en/
MediaChristian MarcouxSenior Vice President,
Global Communications+33 (0)1 58 33 67
94Christian.marcoux@ipsen.com
Fanny AllaireDirector, Ipsen France Hub,
Global Communications+33 (0) 1 58 33 58
96Fanny.allaire@ipsen.com
Financial CommunityEugenia LitzVice President,
Investor Relations+44 (0) 1753 627721eugenia.litz@ipsen.com
Myriam KoutchinskyInvestor Relations Manager+33 (0)1 58
33 51 04myriam.koutchinsky@ipsen.com
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