PARIS–(BUSINESS WIRE)–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
- Specialty Care sales growth of 17.6%1, with continued
-
- Consumer Healthcare sales growth of 3.3%1
-
- Q1 2019 Group sales growth of 17.0% as reported, or 15.8%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.
- Group sales growth greater than 13.0%1 at constant
-
- Core Operating Income margin around 30.0% of net sales (excluding
incremental investments in pipeline expansion initiatives)
- Core Operating Income margin around 30.0% of net sales (excluding
-
- Full Year 2019 guidance confirmed following the completion of the
First quarter 2019 unaudited IFRS consolidated sales
| (in million euros) | Q1 2019 | Q1 2018 |
% Change |
% Change |
|||||
| 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 constant |
|||||
| 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 at |
|||||
| 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) 2071-928-000
France and continental
Europe: + 33 (0) 1 76 70 07 94
UK: 08-445-718-892
U.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).
Contacts
Media
Christian Marcoux
Senior Vice President,
Global Communications
+33 (0)1 58 33 67 94
Christian.marcoux@ipsen.com
Fanny Allaire
Director, Ipsen France Hub,
Global Communications
+33 (0) 1 58 33 58 96
Fanny.allaire@ipsen.com
Financial Community
Eugenia Litz
Vice President,
Investor Relations
+44 (0) 1753 627721
eugenia.litz@ipsen.com
Myriam Koutchinsky
Investor Relations Manager
+33 (0)1
58 33 51 04
myriam.koutchinsky@ipsen.com