Ipsen delivers robust sales growth in the first quarter of 2023 and
confirms its full-year guidance
Ipsen delivers robust sales growth in the first quarter
of 2023 and confirms its full-year
guidance
Paris (France), 27 April
2023Ipsen (Euronext: IPN; ADR: IPSEY), a global
specialty-driven biopharmaceutical company, today presents its
sales performance for the first quarter of 2023.
|
|
Q1 2023 |
Q1 2022 |
% change |
|
€m |
€m |
Actual |
CER1 |
|
|
|
|
|
|
Oncology |
|
570.8 |
556.4 |
2.6% |
1.1% |
Neuroscience |
|
156.4 |
120.2 |
30.2% |
24.4% |
Rare Disease |
|
14.7 |
11.3 |
29.8% |
29.0% |
Total Sales2 |
|
741.9 |
687.9 |
7.8% |
5.7% |
|
|
|
|
|
|
Highlights
- Total-sales growth of 5.7% at CER1, or 7.8% as reported, driven
by the performance of the growth platforms3, up by 14.7%1, with
Dysport® (abobotulinumtoxinA) up by 25.2%1 and Cabometyx®
(cabozantinib) up by 31.0%1, respectively. The performance included
contributions from newly acquired Tazverik® (tazemetostat) and
Bylvay® (odevixibat)
- Completion of the definitive merger agreement for the
acquisition of Albireo, expanding Ipsen’s scope in Rare
Disease
- Regulatory-decision dates in the U.S. confirmed for Bylvay in
Alagille syndrome and palovarotene in fibrodysplasia ossificans
progressiva (FOP), respectively
- Full-year 2023 guidance confirmed, with total-sales growth
greater than 4.0% at CER1 and a core operating margin of around 30%
of total sales
David Loew, Chief Executive Officer,
commented:“Ipsen continues to make excellent progress in
its transformation. We delivered further robust sales growth in the
quarter, led by the standout performances of Dysport and Cabometyx.
Based on the continued sales momentum, we are confirming our
guidance for the full year. I was also delighted by the further
enhancement of our pipeline, portfolio and organization as a result
of the recent acquisition of Albireo; through our global presence,
we will continue to meet the unmet medical needs of an increasing
number of patients. As we replenish the pipeline and execute on
recent transactions, we look forward to several milestones for our
business, including the Phase III data readout for elafibranor and
anticipated regulatory developments for Onivyde, palovarotene and
Bylvay.”
Full-year 2023 guidanceIpsen
has confirmed its financial guidance for FY 20234:
- Total-sales growth greater than
4.0%, at constant exchange rates. Based on the average level of
exchange rates in Q1 2023, an adverse impact on total sales of
around 2% from currencies is expected
- Core operating margin around 30% of
total sales, excluding any potential impact of incremental
investments from future external-innovation transactions
Business development
In March 2023, Ipsen announced that it had
completed the acquisition of Albireo Pharma, Inc., a leading
innovator in bile-acid modulators to treat rare liver conditions.
Ipsen acquired all issued and outstanding shares at a price of
$42.00 per share in cash, plus one non-transferable contingent
value right of $10.00 per share.
Pipeline development
In February 2023, it was announced that the U.S.
Food and Drug Administration had accepted the supplemental New Drug
Application for a second Bylvay indication, for patients with
Alagille syndrome. The administration also issued a Prescription
Drug User Fee Act (PDUFA) action date of 15 June 2023.
In March 2023, it was announced that the PDUFA
action date in the U.S., for the resubmitted New Drug Application
for palovarotene as a potential treatment for FOP, will be 16
August 2023. The Company also recently requested a re-examination
of the negative opinion from the CHMP5 for palovarotene, received
in January 2023.
Conference callA conference
call and webcast for investors and analysts will begin today at
2pm, Paris time. Participants can access the call and its details
by registering here; webcast details can be found here. A recording
will be available on ipsen.com.
CalendarIpsen intends to
publish its half-year and second-quarter results on 27 July
2023.
Notes
All financial figures are in € millions (€m).
The performance shown in this announcement covers the three-month
period to 31 March 2023 (the first quarter or Q1 2023), compared to
the three-month period to 31 March 2022 (Q1 2022), unless stated
otherwise.
Ipsen
Ipsen is a global, mid-sized biopharmaceutical
company focused on transformative medicines in Oncology, Rare
Disease and Neuroscience. With total sales of €3.0bn in FY 2022,
Ipsen sells medicines in over 100 countries. Alongside its
external-innovation strategy, 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
around 5,400 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.
Contacts |
|
Investors |
|
Craig MarksVice President, Investor Relations+44
(0)7584 349 193 |
|
Media |
|
Amy WolfVice President and Head of Corporate Brand
Strategy and Communications+41 79 576 07 23 |
Ioana PiscociuSenior Manager, Global Media
Relations+33 6 69 09 12 96 |
Total sales by therapy area and medicine |
A breakdown of medicine sales by geographical
area is shown in the appendix.
|
|
Q1 2023 |
Q1 2022 |
% change |
|
€m |
€m |
Actual |
CER6 |
|
|
|
|
|
|
Oncology |
|
570.8 |
556.4 |
2.6% |
1.1% |
Somatuline® |
|
263.2 |
286.0 |
-8.0% |
-9.8% |
Cabometyx |
|
130.4 |
98.9 |
31.9% |
31.0% |
Decapeptyl |
|
130.0 |
129.2 |
0.6% |
0.8% |
Onivyde |
|
36.9 |
40.1 |
-7.9% |
-12.3% |
Tazverik |
|
9.2 |
- |
n/a |
n/a |
Other Oncology |
|
1.0 |
2.2 |
-54.0% |
-53.6% |
Neuroscience |
|
156.4 |
120.2 |
30.2% |
24.4% |
Dysport |
|
154.6 |
118.4 |
30.5% |
25.2% |
Other Neuroscience |
|
1.8 |
1.7 |
4.5% |
-18.0% |
Rare Disease |
|
14.7 |
11.3 |
29.8% |
29.0% |
Bylvay |
|
5.0 |
- |
n/a |
n/a |
NutropinAq® |
|
5.4 |
7.1 |
-24.1% |
-24.0% |
Increlex® |
|
4.2 |
4.2 |
-0.6% |
-3.2% |
Total Sales |
|
741.9 |
687.9 |
7.8% |
5.7% |
-
Somatuline® (lanreotide): in
North America, limited sales erosion of 2.7%7, with adverse U.S.
pricing partly offset by a favourable impact reflecting the reduced
level of U.S wholesaler-buying levels in Q1 2022. In Europe, sales
declined by 25.7%7, driven by the impact of generic lanreotide in a
number of markets, including France, Spain and Italy. Sales in the
Rest of the World increased by 7.3%7, a result of solid
performances in several geographies, including Latin America
-
Decapeptyl: performance impacted by reduced sales
in China, reflecting the prior-year benefit from increased stocking
in anticipation of COVID-19 lockdown restrictions, partly offset by
continuous market-share uptakes across a number of geographies
- Cabometyx:
performance reflected strong volume uptakes in renal cell carcinoma
across most geographies, as a second-line monotherapy and as a
first-line therapy in combination with nivolumab in more
countries
- Onivyde:
performance impacted by phasing of shipments to Ipsen’s ex-U.S.
partner, partly offset by the solid underlying growth in the
U.S.
- Tazverik: sales
consolidated for the full quarter, following the completion of the
acquisition of Epizyme in August 2022. Commercial sales growing by
21% year on year7,8
- Dysport:
performance driven by further growth in the aesthetics market,
reflected in increased sales to Ipsen’s partner, Galderma, and
strong demand in most therapeutics markets
- Bylvay: sales
consolidated for one month, following the acquisition of Albireo
that was completed in March 2023
Total sales by geographical area |
|
|
Q1 2023 |
Q1 2022 |
% change |
|
€m |
€m |
Actual |
CER7 |
|
|
|
|
|
|
North America |
|
244.8 |
226.4 |
8.1% |
3.6% |
Europe9 |
|
296.3 |
304.7 |
-2.7% |
-2.3% |
Rest of the World |
|
200.8 |
156.9 |
28.0% |
23.2% |
Total Sales |
|
741.9 |
687.9 |
7.8% |
5.7% |
|
|
|
|
|
|
- North America:
sales grew by 3.6%7, driven by a solid performance from Onivyde and
the contribution from newly acquired medicines Tazverik and Bylvay,
partly offset by reduced sales of Dysport to Galderma in
aesthetics, as well as the gradual erosion of Somatuline
- Europe: sales
declined by 2.3%7, mainly driven by the performance of Somatuline
that reflected the impact of generic lanreotide and by reduced
Onivyde sales to Ipsen’s ex-U.S. partner, offset by strong growth
of Cabometyx, as well as Dysport in the therapeutics and aesthetics
markets
- Rest of the World:
sales grew by 23.2%7, driven by a solid Cabometyx performance and
Dysport, primarily in Latin America, the Middle East and North
Africa
Appendix: geographic breakdown of total sales by
medicine |
|
|
Total |
|
North America |
|
Europe |
|
Rest of the World |
|
Q1 2023 |
Q1 2022 |
% change |
|
Q1 2023 |
Q1 2022 |
% change |
|
Q1 2023 |
Q1 2022 |
% change |
|
Q1 2023 |
Q1 2022 |
% change |
|
€m |
€m |
Actual |
CER10 |
|
€m |
€m |
Actual |
CER10 |
|
€m |
€m |
Actual |
CER10 |
|
€m |
€m |
Actual |
CER10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology |
|
570.8 |
556.4 |
2.6% |
1.1% |
|
202.9 |
184.3 |
10.1% |
5.7% |
|
239.8 |
267.9 |
-10.5% |
-10.0% |
|
128.0 |
104.3 |
22.8% |
19.9% |
Somatuline |
|
263.2 |
286.0 |
-8.0% |
-9.8% |
|
153.7 |
151.5 |
1.4% |
-2.7% |
|
77.4 |
105.5 |
-26.7% |
-25.7% |
|
32.1 |
29.0 |
10.9% |
7.3% |
Cabometyx |
|
130.4 |
98.9 |
31.9% |
31.0% |
|
4.2 |
4.0 |
4.8% |
6.9% |
|
87.1 |
75.2 |
15.7% |
16.3% |
|
39.2 |
19.7 |
99.1% |
85.8% |
Decapeptyl |
|
130.0 |
129.2 |
0.6% |
0.8% |
|
- |
- |
- |
- |
|
73.3 |
73.7 |
-0.5% |
0.1% |
|
56.7 |
55.5 |
2.2% |
1.6% |
Onivyde |
|
36.9 |
40.1 |
-7.9% |
-12.3% |
|
35.7 |
28.7 |
24.7% |
19.1% |
|
1.2 |
11.4 |
-89.5% |
-90.9% |
|
- |
- |
- |
- |
Tazverik |
|
9.2 |
- |
n/a |
n/a |
|
9.2 |
- |
n/a |
n/a |
|
- |
- |
- |
- |
|
- |
- |
- |
- |
Other Oncology |
|
1.0 |
2.2 |
-54.0% |
-53.6% |
|
0.1 |
0.1 |
50.8% |
53.8% |
|
0.9 |
2.0 |
-55.9% |
-55.8% |
|
0.0 |
0.1 |
n/a |
n/a |
Neuroscience |
|
156.4 |
120.2 |
30.2% |
24.4% |
|
36.5 |
39.5 |
-7.5% |
-11.9% |
|
47.7 |
28.4 |
68.1% |
69.6% |
|
72.2 |
52.3 |
38.0% |
29.0% |
Dysport |
|
154.6 |
118.4 |
30.5% |
25.2% |
|
36.5 |
39.5 |
-7.5% |
-11.9% |
|
47.7 |
28.4 |
68.1% |
69.6% |
|
70.3 |
50.5 |
39.1% |
31.0% |
Other Neuroscience |
|
1.8 |
1.7 |
4.5% |
-18.0% |
|
- |
- |
- |
- |
|
- |
- |
- |
- |
|
1.8 |
1.7 |
4.5% |
-18.0% |
Rare Disease |
|
14.7 |
11.3 |
29.8% |
29.0% |
|
5.3 |
2.6 |
n/a |
95.6% |
|
8.7 |
8.4 |
4.0% |
4.2% |
|
0.6 |
0.3 |
n/a |
n/a |
Bylvay |
|
5.0 |
- |
n/a |
n/a |
|
3.0 |
- |
n/a |
n/a |
|
2.0 |
- |
n/a |
n/a |
|
0.0 |
- |
n/a |
n/a |
NutropinAq |
|
5.4 |
7.1 |
-24.1% |
-24.0% |
|
- |
- |
- |
- |
|
5.1 |
6.8 |
-25.0% |
-24.9% |
|
0.3 |
0.3 |
-2.3% |
-1.5% |
Increlex |
|
4.2 |
4.2 |
-0.6% |
-3.2% |
|
2.3 |
2.6 |
-10.2% |
-14.1% |
|
1.5 |
1.5 |
-2.8% |
-2.1% |
|
0.3 |
0.0 |
n/a |
n/a |
Total Sales |
|
741.9 |
687.9 |
7.8% |
5.7% |
|
244.8 |
226.4 |
8.1% |
3.6% |
|
296.3 |
304.7 |
-2.7% |
-2.3% |
|
200.8 |
156.9 |
28.0% |
23.2% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 2021
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 Total sales in this announcement are
unaudited IFRS consolidated sales.3 Dysport, Decapeptyl®
(triptorelin), Cabometyx and Onivyde® (irinotecan).4 The
performance of Consumer HealthCare, divested in July 2022, has been
excluded from all commentary and comparisons to prior performance.5
The Committee for Medicinal Products for Human Use, the European
Medicines Agency's committee responsible for human medicines.6 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.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 Reference to Epizyme’s published Q1 2022 performance.9
Defined in this announcement as the E.U., the U.K., Iceland,
Liechtenstein, Norway and Switzerland.10 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.
- Ipsen - Q1 2023 sales-results announcement
Ipsen (EU:IPN)
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Ipsen (EU:IPN)
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