- Total-sales growth in FY 2023 of
6.7% at CER1 (3.4% as reported) included strong sales from the
growth platforms2 and good contributions from the new medicines. A
core operating margin of 32.0% (IFRS operating margin of 26.1%),
based on further enrichment of the pipeline and accelerated R&D
investment, mainly from recent acquisitions
- Financial guidance for 20243
comprises total-sales growth4 greater than 6.0% at CER1 and a core
operating margin5 around 30% of total sales, including the impact
of four potential launches and an advancing pipeline
- A new phase of growth and mid-term
financial outlook were outlined at the December 2023
capital-markets day
PARIS, FRANCE, 8 February 2024
- Ipsen (Euronext: IPN; ADR: IPSEY), a global
specialty-care biopharmaceutical company, today presents its
financial results for the year and final quarter of 2023.
Extract of consolidated results for FY 2023 and
FY 20226:
|
FY 2023 |
FY 2022 |
% change |
|
€m |
€m |
Actual |
CER1 |
Total Sales |
3,127.5 |
3,025.0 |
3.4% |
6.7% |
Core Operating
Income |
1,001.0 |
1,115.4 |
-10.3% |
|
Core operating margin |
32.0% |
36.9% |
-4.9%
pts |
|
Core Consolidated Net
Profit |
765.5 |
872.4 |
-12.3% |
|
Core
earnings per share (fully diluted) |
€9.15 |
€10.51 |
-13.0% |
|
IFRS Operating
Income |
816.0 |
729.9 |
11.8% |
|
IFRS operating margin |
26.1% |
24.1% |
2.0%
pts |
|
IFRS Consolidated Net
Profit |
647.2 |
647.5 |
- |
|
IFRS
earnings per share (fully diluted) |
€7.73 |
€7.81 |
-1.0% |
|
Free Cash Flow |
710.9 |
817.2 |
-13.0% |
|
Closing
net cash |
65.1 |
398.8 |
-83.7% |
|
“Solid results in the year have provided an
excellent platform for Ipsen in 2024, an exciting period in which
we anticipate four launches and further opportunities to expand the
pipeline”, commented David Loew, Chief Executive Officer, Ipsen.
“As Ipsen transforms, improving execution is supporting consistent
sales growth, while the productive pipeline is yielding further
encouraging results for patients.
“Our external-innovation strategy, underpinned
by a strong balance sheet, continues to extend the number of
potential medicines across our three therapeutic areas. Following
the acquisition of Albireo in 2023 and the successful launch of
Bylvay, we look forward to more milestones this year and enriching
the pipeline over time through additional external-innovation
transactions. I am confident that this strategy will deliver more
medicines for patients and ensure the sustainable growth of
Ipsen.”
2023 progress
Ipsen continued to deliver successfully in 2023
on its strategy, Focus. Together. For patients and society. The
growth platforms produced a further double-digit performance, with
Cabometyx and Dysport up by 22.9%7 and 14.5%7, respectively. There
were contributions from the new medicines, Bylvay® (odevixibat),
Sohonos® (palovarotene) and Tazverik® (tazemetostat), while
Somatuline® (lanreotide), continuing its gradual erosion (-10.4%7),
represented only 34% of total sales (FY 2022: 40%).
The decline in the core operating margin to
32.0% (FY 2022: 36.9%) reflected enhanced investment from the
acquisitions of Albireo and Epizyme, including a higher level of
R&D expenses to fund the new pipeline. Ipsen ended the year
with net cash of €65.1m, driven by solid free cash-flow generation
of €710.9m.
In March 2023, Ipsen enriched its Rare Disease
portfolio and pipeline by acquiring Albireo, a leading innovator in
bile-acid modulators to treat pediatric and adult cholestatic liver
diseases. The primary focus of the transaction was Bylvay, a
potent, once-daily, oral, non-systemic ileal bile acid transport
inhibitor.
Favorable pipeline developments in 2023 included
positive results from the Phase III trials of elafibranor in
primary biliary cholangitis (PBC) and Cabometyx in prostate cancer,
respectively. Regulatory submission acceptances were received for
Onivyde in first-line pancreatic ductal adenocarcinoma (1L PDAC),
as well as for elafibranor. Sohonos and Bylvay were also granted
approval during the year by the U.S. Food and Drug Administration
(FDA) in fibrodysplasia ossificans progressiva (FOP) and Alagille
syndrome, respectively.
2024 priorities and financial
guidance Ipsen anticipates four commercial launches in
2024, following regulatory decisions for Onivyde in 1L PDAC in the
U.S (H1), elafibranor in second-line PBC in the U.S. (H1) and in
the E.U. (H2), as well as odevixibat in Alagille syndrome in the
E.U. (H2). Sohonos, in FOP, was recently launched in the U.S.
The Company will continue to drive benefits from
its global efficiencies program, leveraging its current platform,
which provide significant further investment for launches and the
pipeline.
Ipsen has set the following financial guidance for FY 2024,
which excludes any impact from potential late-stage
external-innovation transactions:
- Total-sales growth greater than
6.0%, at constant currency. Based on the average level of exchange
rates in January 2024, an adverse impact on total sales of
around 1% from currencies is expected
- Core operating margin around 30% of
total sales, which includes additional R&D expenses from
anticipated early and mid-stage external-innovation
opportunities
Guidance on total sales incorporates
expectations for Somatuline of further generic lanreotide products
in the U.S and E.U.
Capital-markets day and mid-term financial
outlook
Ipsen outlined its next phase of growth at its
capital-market day, held in December 2023. Several current and
potential near-term launches are set to be complemented by many
pipeline milestones over the mid-term to build a strengthened and
diversified business, including a combination of seven anticipated
and current medicines, each with expected peak sales of at least
€500m. This will be augmented by an active external-innovation
strategy, designed to provide a platform to drive sustainable
pipeline growth.
The Company outlined the following mid-term
financial outlook8:
- Total-sales average growth of at
least 7% per year for the period 2023-2027 at constant exchange
rates
- A core operating margin in 2027 of
at least 32% of total sales
Environment, Social and Governance:
Generation IpsenIpsen presented an ambitious
sustainability roadmap at the aforementioned capital-markets day,
based on Generation Ipsen, the strategy focused on four pillars:
Environment, Patients, People and Governance. Good progress was
made in 2023.
Ipsen is committed to science-based reductions
in greenhouse-gas emissions across the entire value chain. The
Company achieved a 36% reduction in Scope 1 & 2 emissions in
2023 vs the 2019 baseline. Scope 3 reductions in 2023, against the
same baseline year, amounted to 29%. Ipsen has the ambition to be
carbon-neutral by the end of 2025 and reach net-zero emissions by
2045.
With a key focus on patients, the Company has
made progress to reduce the length of time between clinical-trial
readouts and non-FDA/EMA9 regulatory submissions by 25%. In 2023,
53% of the GLT was comprised of women versus 48% in 2022, while 43%
of colleagues were engaged in healthcare or environmental projects
in 2023.
Finally, ISO37001 certification for anti-corruption management
was renewed in the year.
Consolidated financial statements
The Board of Directors approved the consolidated
financial statements on 7 February 2024. The consolidated financial
statements have been audited and the Statutory Auditors’ report is
in the process of being published. Ipsen’s comprehensive audited
financial statements will be available in due course on ipsen.com
(regulated-information section).
Conference callA conference
call and webcast for investors and analysts will begin today at 2pm
CET. Participants can access the call and its details by
registering here; webcast details can be found here.
CalendarIpsen intends to
publish its first-quarter sales update on 25 April 2024.
NotesAll financial figures are
in € millions (€m). The performance shown in this announcement
covers the twelve-month period to 31 December 2023 (FY 2023)
and the three-month period to 31 December 2023 (Q4 2023),
compared to the twelve-month period to 31 December 2022 (FY
2022) and the three-month period to 31 December 2022
(Q4 2022), respectively, unless stated otherwise. Commentary
is based on the performance in FY 2023, unless stated
otherwise.
About Ipsen
We are a global biopharmaceutical company with a
focus on bringing transformative medicines to patients in three
therapeutic areas: Oncology, Rare Disease and Neuroscience.
Our pipeline is fueled by external innovation
and supported by nearly 100 years of development experience and
global hubs in the U.S., France and the U.K. Our teams in more than
40 countries and our partnerships around the world enable us to
bring medicines to patients in more than 100 countries.
Ipsen 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.
Ipsen contacts
InvestorsCraig Marks +44
(0)7584 349 193Nicolas Bogler +33 6 52 19 98
92
MediaAmy Wolf +41 79 576 07
23Ioana Piscociu +33 6 69 09 12 96
Disclaimers and/or 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 latest
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 Dysport® (abobotulinumtoxinA),
Decapeptyl® (triptorelin), Cabometyx® (cabozantinib) and Onivyde®
(irinotecan).3 Excludes any impact from potential late-stage
external-innovation transactions.4 Incorporates expectations for
Somatuline of further generic-lanreotide products in the U.S and
E.U. and excluding, based on the average level of exchange rates in
January 2024, an adverse expected impact on total sales of around
1% from currencies.5 Includes additional R&D expenses from
anticipated early and mid-stage external-innovation opportunities.6
Extract of consolidated results. The Company’s auditors performed
an audit of the consolidated financial statements.7 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.8 Excluding the impact of any potential
additional late-stage (Phase III clinical development or later)
external-innovation opportunities.9 European Medicines Agency.
- FY 2023 - results announcement
Ipsen (EU:IPN)
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