Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven
biopharmaceutical group, publishes its sales performance for the
first quarter of 2021:
Q1 2021 sales summary (unaudited IFRS consolidated
sales)
Q1 2021
€m
% change
Actual
CER1
Specialty Care
611.5
1.5
6.4
Consumer Healthcare
47.0
-9.6
-5.4
Total Sales
658.5
0.6
5.5
Highlights
- Total Sales growth of 5.5% at CER, or 0.6% as reported, to
€658.5m, despite impact of the pandemic
- An increase in Specialty Care sales of 6.4%1 to €611.5m, driven
by the growth of Cabometyx® (cabozantinib), Decapeptyl®
(triptorelin), Somatuline® (lanreotide) and Dysport® (botulinum
toxin type A)
- A Consumer Healthcare sales decline of 5.4%1 to €47.0m,
reflecting the ongoing effects of COVID-19, partly offset by
recovery in China
- European Commission approval of Cabometyx®, in combination with
nivolumab, as a first-line treatment for patients living with
advanced renal cell carcinoma
- Guidance for FY 2021 confirmed
David Loew, Chief Executive Officer, commented: “We
delivered a strong performance in the first quarter, despite the
persistently difficult COVID-19 environment, driven by our
unrelenting focus on patients. Our execution was in line with our
plans and our financial guidance for the year. Ipsen’s Oncology
medicines stood out in the period, while the regulatory approval in
Europe of the Cabometyx® combination with nivolumab in first-line
renal cell carcinoma marked the start of an important launch. The
anticipated registration of a lanreotide-generic medicine in Europe
is fully aligned with our expectations.
In the near term, we look forward to trial results in first-line
liver cancer for the Cabometyx® combination with atezolizumab, as
well as regulatory progress with palovarotene in FOP. We continue
to support our ambitions of strengthening the pipeline and driving
sustainable growth, based on our patient-focused strategy. I am
very proud of the great execution by colleagues around the world,
especially as many teams continue to experience challenging
conditions during the pandemic.”
FY 2021 guidance The Company today confirms its financial
guidance for FY 2021, which incorporates an assumed progressive
global recovery from COVID-19 by H2 2021. A phased launch of
generic lanreotide in Europe by mid-2021 is also assumed, as is a
limited impact of the potential launch of octreotide or lanreotide
generics in the U.S.
Total Sales
Growth of more than 4.0% at
CER
Core Operating Margin
Greater than 30.0%, excluding any
potential impact of incremental investments from external
innovation
Currency impact Ipsen anticipates an adverse impact of 2%
from currencies on Total Sales in FY 2021, based on the level of
exchange rates at the end of March 2021.
Somatuline®-generic update During the quarter, a
positive outcome was received for a generic formulation of
lanreotide in 60mg, 90mg and 120mg dose presentations by the
Reference Member State, Denmark; the closure of the Decentralized
Procedure was also achieved. National marketing authorizations have
recently been granted for a lanreotide generic medicine in France,
Denmark, Hungary and Latvia. These developments were consistent
with Ipsen’s expectations.
Business development In the quarter, Ipsen and Fusion
Pharmaceuticals Inc. completed an asset purchase agreement to
acquire Ipsen's intellectual property and assets related to
IPN-1087, a small molecule in Phase I development targeting
neurotensin receptor 1, a protein expressed on multiple solid-tumor
types.
Conference call A conference call and webcast for
investors and analysts will begin at 2:30pm Paris time today.
Participants should dial in to the call early and can register
here; a recording will be available on ipsen.com, while the webcast
can be accessed here. The event ID is 2495337.
Calendar The Company intends to publish its H1 2021
results on 29 July 2021 and its nine-months’ sales update on 21
October 2021. The Annual Shareholders’ Meeting will be held behind
closed doors on 27 May 2021.
Notes All financial figures are in € millions (€m). The
performance shown in this announcement covers the three-month
period to 31 March 2021 (the quarter, the first quarter or Q1
2021), compared to three-month period to 31 March 2020 (Q1 2020)
respectively, unless stated otherwise. Growth rates are at CER,
unless stated otherwise. Commentary on performance is based on CER,
unless stated otherwise.
Ipsen Ipsen is a global, mid-sized biopharmaceutical
company focused on transformative medicines in Oncology,
Neuroscience and Rare Disease; it also has a well-established
Consumer Healthcare business. With Total Sales of over €2.5bn in FY
2020, Ipsen sells more than 20 medicines in over 115 countries,
with a direct commercial presence in more than 30 countries. The
Company’s research and development efforts are focused on its
innovative and differentiated technological platforms located in
the heart of leading biotechnological and life-science hubs:
Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai,
China. Ipsen has c.5,700 colleagues worldwide and is listed in
Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I
American Depositary Receipt program (ADR: IPSEY). For more
information, visit ipsen.com.
Sales by therapeutic area and
product
Q1 2021
€m
% change
Actual
CER2
Total Specialty Care
611.5
1.5
6.4
Oncology
495.4
0.6
4.9
Somatuline®
277.0
-3.0
2.5
Decapeptyl®
106.3
10.0
12.0
Cabometyx®
83.3
15.0
16.4
Onivyde®
26.5
-15.0
-6.9
Other Oncology
2.4
-65.6
-65.7
Neuroscience
103.1
10.3
19.8
Dysport®
101.8
9.6
18.9
Rare Disease
13.1
-21.1
-19.4
NutropinAq®
8.5
-24.0
-23.9
Increlex®
4.6
-15.2
-9.7
Total Consumer
Healthcare
47.0
-9.6
-5.4
Smecta®
16.3
-8.8
-4.9
Forlax®
9.1
-7.6
-5.6
Tanakan®
8.5
-16.4
-10.0
Fortrans/Eziclen®
6.8
-0.7
6.1
Other Consumer Healthcare
6.3
-13.5
-10.6
Total Sales
658.5
0.6
5.5
Specialty Care Sales amounted to €611.5m, an increase of
6.4%2. Oncology and Neuroscience sales increased by 4.9%2 and
19.8%2 to €495.4m and €103.1m, respectively, while Rare Disease
sales declined by 19.4%2 to €13.1m.
In the quarter, Specialty Care comprised 93% of Total Sales (Q1
2020: 92%).
Oncology Sales of €495.4m
represented growth of 4.9%2. The performance was encouraging,
particularly after challenges for the treatment of cancer patients
during the pandemic, as well as the comparative impact of limited
increased stocking in Q1 2020 in some European countries. Improved
conditions in China underpinned the strong performance of
Decapeptyl®, while there were also good results for Cabometyx® and
Somatuline® globally.
In the quarter, Oncology sales comprised 75% of Total Sales (Q1
2020: 75%).
- Somatuline® sales reached €277.0m, an increase of 2.5%2,
with growth of 5.1%2 in North America that reflected strong
volumes, even with the adverse ongoing impacts of COVID-19 on
patient diagnoses and treatments. The performance was also a result
of continued market-share gains in most geographies, despite the
high level of Somatuline® orders in March 2020. There was only a
limited impact from generic-octreotide sales in Europe.
- Decapeptyl® sales of €106.3m reflected growth of 12.0%2,
mainly driven by China, which significantly recovered from the
impacts of COVID-19. This was offset by lower sales in Europe,
reflecting the level of pandemic-related stocking in Q1 2020.
- Cabometyx® sales reached €83.3m, up by 16.4%2, driven by
a strong volume uptake across most geographies in both renal cell
carcinoma and hepatocellular carcinoma.
- Onivyde® sales of €26.5m, down by 6.9%2, reflected
mainly the impact of the pandemic on cancer treatment in the
U.S.
Neuroscience Dysport® sales
reached €101.8m, up by 18.9%2, mainly driven by Galderma’s solid
performance in the aesthetics market in Brazil and North America,
along with growth in the Middle East and higher volumes in the
Brazil and Mexico therapeutics markets. Sales in Europe continued
to be impacted by the pandemic across aesthetics and therapeutics
markets.
In the quarter, Neuroscience sales comprised 16% of Total Sales
(Q1 2020:14%).
Rare Disease NutropinAq®
(somatropin) sales of €8.5m, a decline of 23.9%2, reflected a
slowdown in the market and competitive pressures across Europe. A
decline in Increlex® (mecasermin) sales of 9.7%2 to €4.6m
was a result of lower demand in the U.S., reflecting the ongoing
effects of COVID-19.
In the quarter, Rare Disease sales comprised 2% of Total Sales
(Q1 2020: 3%).
Consumer Healthcare Sales of €47.0m, a decline of 5.4%2,
was a result of a 4.9%2 fall in sales of Smecta®
(diosmectite) that was driven by the slowdown of the diarrhea
market in Europe, partly offset by the recovery in China.
Fortrans/Eziclen® (macrogol 4000) sales increased by 6.1%2,
also reflecting the China recovery. Tanakan® (ginkgo biloba
extract) sales declined by 10.0%2, mainly due to the level of
demand in Q1 2020 in Russia.
In the quarter, Consumer Healthcare sales comprised 7% of Total
Sales (Q1 2020: 8%).
Sales by geographical
area
Q1 2021
€m
% change
Actual
CER2
Major Western European
Countries
217.5
-3.0
-2.5
France
74.5
-5.4
-4.8
Germany
53.1
5.6
5.6
Italy
33.0
-6.4
-6.4
UK
28.6
-4.7
-3.0
Spain
28.3
-5.2
-5.2
Other European
Countries
120.6
-8.7
-3.7
Eastern Europe
54.0
-5.8
3.7
Other Europe
66.6
-11.0
-9.2
North America
207.0
-3.9
4.8
Rest of the World
113.5
36.8
44.5
Asia
54.0
70.7
73.4
Other Rest of the World
59.6
15.9
26.2
Total Sales
658.5
0.6
5.5
Major Western European countries Sales reached €217.5m, a
decline of 2.5%2. Major Western European countries comprised 33% of
Total Sales (Q1 2020: 34%).
- France: sales of €74.5m, reflecting a decline of 4.8%2,
were affected by a high level of orders in Q1 2020, due to
COVID-19, and a slowdown of the diarrhea market impacting Consumer
Healthcare.
- Germany: sales reached €53.1m, up by 5.6%2, mainly
driven by continued market-share gains for Cabometyx® and
Somatuline®, with only a limited impact from the sale of generic
octreotide.
- Italy: Sales of €33.0m, reflecting a decline of 6.4%2,
were a result of a high level of orders of Decapeptyl® and
Somatuline® in Q1 2020, partly compensated by Cabometyx® growth
from market-share gains.
- U.K.: Sales reached €28.6m, a decrease of 3.0%2, with
adverse performances of Decapeptyl® and Dysport®, impacted by
COVID-19, outweighing solid growth of Somatuline®.
- Spain: Sales of €28.3m reflecting a decline of 5.2%2,
with the high level of orders in Q1 2020 from COVID-19 mainly
impacting the performance of Cabometyx®.
Other European countries Sales reached €120.6m, down by
3.7%2, mainly driven by reduced Consumer Healthcare sales in
Eastern Europe, despite successful launches and market-share gains
for Cabometyx®.
In the quarter, sales in Other European countries comprised 18%
of Total Sales (Q1 2020: 20%).
North America Sales of €207.0m reflected growth of 4.8%2,
driven by continued strong Somatuline® and Cabometyx® demand,
despite an overall adverse impact from the pandemic on cancer
treatment. Dysport® sales reflected a good performance in the
aesthetics market and growth in the therapeutics market, after the
impact of COVID-19 in FY 2020.
In the quarter, sales in North America comprised 31% of Total
Sales (Q1 2020: 33%).
Rest of the World Sales reached €113.5m, an increase of
44.5%2, driven by a China recovery that resulted in strong
Decapeptyl® and Consumer Healthcare sales. This was accompanied by
a solid Dysport® performance in Latin America and the Middle
East.
In the quarter, sales in the Rest of the World comprised 17% of
Total Sales (Q1 2020: 13%).
Forward-looking statements 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 2020 Registration
Document, available on ipsen.com.
_________________ 1 At constant exchange rates (CER), which
excludes any foreign-exchange impact by recalculating the
performance for the relevant period by applying the exchange rates
used for the prior period. 2 At CER, which excludes any
foreign-exchange impact by recalculating the performance for the
relevant period by applying the exchange rates used for the prior
period.
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Investors Craig Marks
Vice President, Investor Relations +44 7584 349 193
Adrien Dupin de Saint-Cyr Investor Relations Manager +33
6 64 26 17 49
Media Gwenan White
Executive Vice President, Communications and Public Affairs +44
7876 391 429
Fanny Allaire Global Communications Director +33 6 08 91
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