Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven
biopharmaceutical group, publishes its sales performance for the
third quarter of 2021 and the year to date.
Sales summary (unaudited IFRS consolidated sales)
Third Quarter
Year To Date
2021
2020
% change
2021
2020
% change
€m
€m
Actual
CER1
€m
€m
Actual
CER1
Specialty Care
667.8
580.5
15.0%
15.1%
1,912.3
1,747.6
9.4%
12.5%
Consumer Healthcare
59.6
52.8
12.8%
12.2%
165.5
154.0
7.5%
9.8%
Total Sales
727.4
633.3
14.9%
14.9%
2,077.7
1,901.6
9.3%
12.3%
Highlights – Total sales growth of 12.3% at CER1 in the
year to date, or 9.3% as reported, to €2,077.7m. In the third
quarter, total sales of €727.4m represented growth of 14.9% at CER1
and as reported
– An increase in Specialty Care sales in the year to date
of 12.5%1 to €1,912.3m, driven by the growth of Somatuline®
(lanreotide), Cabometyx® (cabozantinib), Decapeptyl® (triptorelin)
and Dysport® (botulinum toxin type A)
– Consumer Healthcare sales growth of 9.8%1 in the year
to date to €165.5m, reflecting the performance of Smecta®
(diosmectite) and the strong COVID-19 recovery
– Strong business-development activity, with agreements
in Oncology and Neuroscience
– Full-year guidance upgraded:
- Total sales growth1: greater than +11.0% (prior guidance:
greater than +8.0%)
- Core operating margin2: around 34% (prior guidance: around
32.0%)
David Loew, Chief Executive Officer, commented: “We
delivered a strong performance in the third quarter, reflecting the
implementation of our new strategy and improving levels of
commercial execution. Somatuline and Cabometyx growth was
particularly encouraging, while strong sales of Dysport continue to
underpin confidence in the potential of this important medicine.
Despite regulatory delays for palovarotene in FOP, the
replenishment of our pipeline gathered pace, with our
external-innovation strategy providing an exciting platform for
sustainable top-line growth.
We continue to maximize our brands, strengthen the pipeline and
are driving efficiencies across our business. This strategy, built
on our culture and an unrelenting focus on patients, is delivering
strong results, giving us the confidence to upgrade this year’s
guidance while remaining focused on the long-term Ipsen growth
story.”
FY 2021 guidance Based on the strong performance in the
year to date, the gradual easing of the COVID-19 pandemic and a
limited impact from the launch of generic lanreotide in Europe, the
Company today upgrades its financial guidance for FY 2021:
New guidance
Prior guidance
Total sales growth3
Greater than 11.0%
Greater than 8.0%
Core operating margin4
Around 34%
Around 32.0%
Currency impact Ipsen anticipates an unchanged adverse
impact of 2% from currencies on total sales in FY 2021, based on
the level of exchange rates at the end of September 2021.
Business development Since the publication of the H1 2021
results announcement, Ipsen signed two agreements in line with its
external-innovation focus on strengthening the pipeline:
METTL3 (Oncology) In October 2021,
Ipsen and Accent Therapeutics (Accent) signed an exclusive
worldwide-collaboration agreement to research, develop,
manufacture, and commercialize Accent’s pre-clinical stage METTL3
program. This collaboration reinforces Ipsen’s expansion into
hematological malignancies, with a focus on acute myeloid
leukemia.
Spherical Nucleic Acids
(Neuroscience) In August 2021, Ipsen entered into an
exclusive collaboration agreement with Exicure to research,
develop, and commercialize novel Spherical Nucleic Acids as
potential investigational treatments for Huntington’s disease and
Angelman syndrome.
Palovarotene In August 2021, Ipsen withdrew the New Drug
Application (NDA) for palovarotene in FOP5, after discussions with
the U.S. Food and Drug Administration (FDA). This followed ongoing
dialogue with the FDA after the acceptance of the NDA for Priority
Review, announced in May 2021. During the review and the ongoing
dialogue, it was recognized that additional analyses and evaluation
of data collected from Ipsen’s Phase III MOVE and FOP program would
be required to progress and complete the review process. It was
agreed that it would not be possible to complete this within the
NDA review cycle. Upon successful completion of the additional data
analyses, Ipsen currently anticipates regulatory resubmission in
the U.S. in H1 2022. A ‘clock-stop’ was also granted by the
European Medicines Agency.
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 4312698.
Calendar The Company intends to publish its FY 2021
results on 11 February 2022.
Notes All financial figures are in € millions (€m). The
performance shown in this announcement covers the nine-month period
to 30 September 2021 (the year to date or YTD 2021) and the
three-month period to 30 September 2021 (the third quarter or Q3
2021), compared to nine-month period to 30 September 2020 (YTD
2020) and the three-month period to 30 September 2020 (Q3 2020)
respectively, unless stated otherwise. Commentary is based on the
performance in YTD 2021, unless stated otherwise.
Ipsen Ipsen is a global, mid-sized biopharmaceutical
company focused on transformative medicines in Oncology, Rare
Disease and Neuroscience; 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
Third Quarter
Year To Date
2021
2020
% change
2021
2020
% change
€m
€m
Actual
CER6
€m
€m
Actual
CER6
Total Specialty Care
667.8
580.5
15.0%
15.1%
1,912.3
1,747.6
9.4%
12.5%
Oncology
552.3
479.1
15.3%
15.2%
1,565.4
1,446.5
8.2%
11.0%
Somatuline
313.0
272.9
14.7%
15.0%
874.4
835.1
4.7%
8.5%
Decapeptyl
110.1
94.5
16.5%
15.0%
332.6
288.0
15.5%
15.9%
Cabometyx
91.8
76.8
19.5%
19.2%
258.6
213.6
21.1%
21.6%
Onivyde®
35.2
27.5
28.0%
29.2%
93.0
90.0
3.3%
10.4%
Other Oncology
2.2
7.4
-70.2%
-70.4%
6.7
19.8
-65.9%
-66.2%
Neuroscience
103.8
87.9
18.1%
19.1%
309.6
258.4
19.8%
25.1%
Dysport
102.5
87.4
17.3%
18.2%
305.3
256.9
18.8%
24.0%
Rare Diseases
11.7
13.5
-13.5%
-13.7%
37.3
42.6
-12.5%
-11.3%
NutropinAq®
7.5
8.5
-12.6%
-13.0%
24.5
27.7
-11.6%
-11.9%
Increlex®
4.2
5.0
-14.9%
-14.7%
12.8
14.9
-14.0%
-10.1%
Total Consumer
Healthcare
59.6
52.8
12.8%
12.2%
165.5
154.0
7.5%
9.8%
Smecta
27.9
20.2
38.1%
36.4%
63.5
58.0
9.6%
11.9%
Tanakan®
7.3
7.2
1.8%
0.6%
27.9
26.6
5.0%
8.7%
Forlax®
8.6
10.2
-16.0%
-16.0%
25.8
30.0
-13.9%
-12.9%
Fortrans/Eziclen®
9.3
7.2
30.1%
29.4%
26.0
19.0
36.8%
40.6%
Other Consumer Healthcare
6.5
8.1
-19.4%
-18.6%
22.2
20.4
8.7%
10.7%
Total Sales
727.4
633.3
14.9%
14.9%
2,077.7
1,901.6
9.3%
12.3%
Specialty Care In the year to date, Specialty Care sales
amounted to €1,912.3m, an increase of 12.5%7. Oncology and
Neuroscience sales increased by 11.0%7 and 25.1%7 to €1,565.4m and
€309.6m, respectively, while Rare Disease sales declined by 11.3%7
to €37.3m.
Specialty Care comprised 92.0% of total sales (YTD 2020:
91.9%).
Oncology Sales of €1,565.4m in the
year to date represented growth of 11.0%7 reflecting good
performance from Somatuline, Cabometyx and Decapeptyl, driven by
continued market-share gains in most markets and a strong
Decapeptyl recovery in China.
Oncology sales comprised 75.3% of total sales (YTD 2020:
76.1%).
- Somatuline sales reached €874.4m, an increase of 8.5% 7
, with growth of 9.3% 7 in North America that reflected strong
volumes, even with the residual impact of COVID-19 on patient
diagnoses and treatments. The performance was also a result of
continued market-share gains in most geographies. There was only a
limited impact from generic octreotide and no impact of generic
lanreotide sales in Europe.
- Decapeptyl sales of €332.6m reflected growth of 15.9% 7
, mainly driven by China, which significantly recovered from the
impacts of COVID-19, along with market-share gains in rest of Asia,
France and Spain.
- Cabometyx sales reached €258.6m, up by 21.6% 7 , driven
by a strong volume uptake across most geographies in both renal
cell carcinoma and hepatocellular carcinoma.
- Onivyde (irinotecan liposome injection) sales of €93.0m,
growing by 10.4% 7 , were driven by higher sales to Ipsen’s ex-U.S.
partner and higher volumes in the U.S.
Neuroscience Dysport sales
in the year to date reached €305.3m, up by 24.0%7, driven by a
strong recovery from the pandemic in most geographies for
aesthetics markets, mainly in the Middle East, Turkey and Russia,
along with therapeutics markets in North America and Europe. There
was also a continued solid aesthetics performance from Ipsen’s
partner, Galderma, in most of its markets.
Neuroscience sales comprised 14.9% of total sales (YTD 2020:
13.6%).
Rare Disease NutropinAq
(somatropin) sales in the year to date of €24.5m, a decline of
11.9%7, reflected a slowdown in the market and competitive
pressures across Europe. A decline in Increlex (mecasermin)
sales of 10.1%7 to €12.8m was a result of lower demand in the U.S.,
reflecting the ongoing effects of COVID-19.
Rare Disease sales comprised 1.8% of total sales (YTD 2020:
2.2%).
Consumer Healthcare Sales of €165.5m in the year to date,
up by 9.8%7, was a result of the 11.9%7 growth in sales of
Smecta to €63.5m that was driven by the COVID-19 recovery in
China and Russia. Fortrans/Eziclen (macrogol 4000) sales
increased by 40.6%7 to €26.0m, also reflecting the recovery in
China. Tanakan (ginkgo biloba extract) sales increased by
8.7%7 to €27.9m, driven by performance and a high level of
deliveries in Vietnam.
Consumer Healthcare sales comprised 8.0% of total sales (YTD
2020: 8.1%).
Sales by geographical area
Third Quarter
Year To Date
2021
2020
% change
2021
2020
% change
€m
€m
Actual
CER8
€m
€m
Actual
CER8
Major Western European
Countries
218.3
201.4
8.4%
7.5%
659.1
615.7
7.0%
6.9%
France
77.7
73.2
6.2%
6.2%
233.1
220.0
6.0%
6.5%
Germany
48.0
52.1
-7.8%
-7.8%
150.2
146.1
2.8%
2.8%
Italy
31.1
21.8
42.5%
42.5%
96.5
82.9
16.4%
16.4%
U.K.
31.3
28.2
11.2%
5.0%
90.0
85.6
5.1%
2.8%
Spain
30.1
26.1
15.4%
15.4%
89.2
81.0
10.1%
10.1%
Other European
Countries
136.6
115.1
18.8%
19.6%
394.2
364.3
8.2%
11.8%
Eastern Europe
66.7
50.9
30.9%
31.2%
185.5
157.9
17.4%
23.5%
Others Europe
70.0
64.1
9.1%
10.2%
208.8
206.4
1.2%
2.9%
North America
246.8
204.5
20.7%
21.7%
649.8
623.3
4.2%
10.6%
Rest of the World
125.7
112.4
11.8%
10.6%
374.6
298.2
25.6%
27.6%
Asia
62.6
60.0
4.4%
1.8%
188.9
135.7
39.2%
38.7%
Other Rest of the World
63.1
52.4
20.4%
20.6%
185.7
162.5
14.3%
18.3%
Total Sales
727.4
633.3
14.9%
14.9%
2,077.7
1,901.6
9.3%
12.3%
Major Western European countries In the year to date,
sales reached €659.1m, an increase of 6.9%8. Major Western European
countries comprised 31.7% of total sales (YTD 2020: 32.4%).
- France: sales of €233.1m, reflecting growth of 6.5% 8 ,
reflected a solid recovery from the pandemic, with continued
market-share gains for Somatuline and Decapeptyl, along with
additional Onivyde sales to Ipsen’s ex-U.S. partner. This was
offset by the effect of a low diarrhea market impacting the
Consumer Healthcare performance.
- Germany: sales reached €150.2m, up by 2.8% 8 , mainly
driven by continued market-share gains for Cabometyx and
Somatuline, with no material impact from the launch of generic
lanreotide.
- Italy: sales of €96.5m, up by 16.4% 8 , were mainly a
result of a solid Cabometyx uptake and the Somatuline
performance.
- U.K.: sales reached €90.0m, an increase of 2.8% 8 ,
mainly driven by a strong Somatuline performance, partly offset by
lower volumes of Decapeptyl.
- Spain: sales of €89.2m reflected growth of 10.1% 8 ,
driven by market-share gains for Somatuline and Decapeptyl.
Other European countries In the year to date, sales
reached €394.2m, up by 11.8%9, mainly driven by market-share gains
and successful launches for Cabometyx, strong Dysport performances
in Turkey and Russia, along with good Consumer Healthcare sales in
Eastern Europe.
Other European countries sales comprised 19.0% of total sales
(YTD 2020: 19.2%).
North America Sales of €649.8m in the year to date
reflected growth of 10.6%9, driven by continued strong Somatuline
and Cabometyx demand, despite an overall adverse impact from the
pandemic on cancer treatment. Strong Dysport sales reflected good
performance in the aesthetics and therapeutics markets after the
impact of COVID-19 in 2020.
North America sales comprised 31.3% of total sales (YTD 2020:
32.8%).
Rest of the World Sales reached €374.6m in the year to
date, an increase of 27.6%9, driven by the 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, along with good Decapeptyl sales mainly in South
Korea and Taiwan.
Rest of the World sales comprised 18.0% of total sales (YTD
2020: 15.7%).
Forward-looking statements The forward-looking
statements, objectives and targets contained herein are based on
Ipsen’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 Ipsen’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 Ipsen’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 Ipsen.
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
medicine 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. Ipsen must
face or might face competition from generic medicine 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 Ipsen may fail to achieve its
objectives and be forced to abandon its efforts with regards to a
medicine in which it has invested significant sums. Therefore,
Ipsen cannot be certain that favorable results obtained during
preclinical 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 medicine
concerned. There can be no guarantees a medicine will receive the
necessary regulatory approvals or that the medicine 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 healthcare legislation; global trends toward healthcare cost
containment; technological advances, new medicine and patents
attained by competitors; challenges inherent in new-medicine
development, including obtaining regulatory approval; Ipsen'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 Ipsen’s patents and other protections for
innovative medicines; and the exposure to litigation, including
patent litigation, and/or regulatory actions. Ipsen also depends on
third parties to develop and market some of its medicines which
could potentially generate substantial royalties; these partners
could behave in such ways which could cause damage to Ipsen’s
activities and financial results. Ipsen 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
Ipsen’s partners could generate lower revenues than expected. Such
situations could have a negative impact on Ipsen’s business,
financial position or performance. 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 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
Ipsen’s 2020 Universal Registration Document, available on
ipsen.com.
1 At constant exchange rates (CER), which exclude any
foreign-exchange impact by recalculating the performance for the
relevant period by applying the exchange rates used for the prior
period. 2 As a ratio of core operating income to total sales. 3 At
CER, which exclude any foreign-exchange impact by recalculating the
performance for the relevant period by applying the exchange rates
used for the prior period. 4 As a ratio of core operating income to
total sales. 5 Fibrodysplasia ossificans progressiva. 6 At CER,
which exclude any foreign-exchange impact by recalculating the
performance for the relevant period by applying the exchange rates
used for the prior period. 7 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. 8 At CER, which exclude any foreign-exchange impact by
recalculating the performance for the relevant period by applying
the exchange rates used for the prior period. 9 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
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