PARIS, FRANCE, 25 July 2024 -
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care
biopharmaceutical company, today presents its financial results for
the first half of 2024.
Business highlights
- U.S. regulatory
approvals and launches of Onivyde® (irinotecan) in
first-line pancreatic cancer and Iqirvo®
(elafibranor) in second-line primary biliary cholangitis,
respectively
- In-licensing of
tovorafenib outside the U.S.: an attractive addition to our
Oncology pipeline
- Multiple
early-stage external-innovation transactions across Oncology and
Neuroscience
Financial highlights
- Total-sales growth of 9.5% at CER1,
or 8.0% as reported, driven by the performances of
Cabometyx® (cabozantinib) and
Dysport® (abobotulinumtoxinA), as well as
contributions from Bylvay® (odevixibat) and
Onivyde
- Core operating margin of 32.4%, a
decline of 1.6% points, driven mainly by enhanced R&D
investment. An unchanged IFRS operating margin of 19.2%
- Upgraded 2024 financial guidance:
total-sales growth greater than 7.0% at CER1
(prior guidance: greater than 6.0% at CER1); core
operating margin greater than 30.0% of total sales (prior guidance:
around 30%)
“Our strategic progress was illustrated by
strong results in the first half, and we are well placed to deliver
continued attractive growth over the medium term”, commented David
Loew, Chief Executive Officer, Ipsen. “Across Oncology, Rare
Disease and Neuroscience, we now have a comprehensive portfolio of
medicines, with additional launches in key indications this year.
Onivyde and Iqirvo are now being rolled out and we are confident in
our ability to deliver on their potential. I was also delighted by
a further expansion of our pipeline, including the recent
in-licensing of the late-stage asset, tovorafenib, in pediatric
Oncology.
“Over the remainder of the year, we will remain
sharply focused on the launches and commercial execution, as well
as further opportunities to expand the pipeline. We have a clear
and focused strategic roadmap and a culture of excellence in
execution to enable us to make a real difference for patients and
society.”
Extract of consolidated results for H1 2024 and
H1 20232:
|
|
H1 2024 |
H1 2023 |
% change |
|
€m |
€m |
Actual |
CER3 |
Total Sales |
|
1,659.3 |
1,536.6 |
8.0% |
9.5% |
Core Operating Income |
|
538.0 |
523.2 |
2.8% |
|
Core operating margin |
|
32.4% |
34.0% |
-1.6% pts |
|
Core Consolidated Net Profit |
|
399.4 |
393.0 |
1.6% |
|
Core earnings per share (fully diluted) |
|
€4.78 |
€4.73 |
1.2% |
|
IFRS Operating Income |
|
317.8 |
295.6 |
7.5% |
|
IFRS operating margin |
|
19.2% |
19.2% |
- |
|
IFRS Consolidated Net Profit |
|
232.3 |
195.1 |
19.1% |
|
IFRS earnings per share (fully diluted) |
|
€2.78 |
€2.35 |
18.4% |
|
Free Cash Flow |
|
393.5 |
371.5 |
5.9% |
|
Closing net debt |
|
(6.8) |
(272.2) |
n/a |
|
Full-year 2024 guidanceWe have
upgraded our financial guidance for 2024:
- Total-sales growth
greater than 7.0%, at constant currency (prior guidance: greater
than 6.0% at constant currency). Based on the average level of
exchange rates in June 2024, an adverse impact on total sales of
around 1% from currencies is expected
- Core operating
margin greater than 30.0% of total sales (prior guidance: around
30%)
Pipeline update since Q1 2024In
June 2024, we received an accelerated approval from the U.S. FDA
for Iqirvo 80 mg tablets for the treatment of primary biliary
cholangitis, in combination with ursodeoxycholic acid (UDCA), in
adults who have an inadequate response to UDCA, or as monotherapy
in patients unable to tolerate UDCA. Iqirvo was, shortly
thereafter, available for prescription and delivery. A decision in
the E.U. is anticipated later this year.
In June 2024, we announced the expansion of our
collaboration and license agreement with Exelixis, Inc. for the
development of Cabometyx® (cabozantinib) in advanced pancreatic
neuroendocrine tumors and advanced extra-pancreatic neuroendocrine
tumors. This expansion is based on positive outcomes from the
CABINET Phase III trial.
In June 2024, we announced an extension of our
ongoing oncology research partnership with Marengo Therapeutics,
Inc., to include TriSTAR, Marengo’s next-generation, precision
T-cell engager technology. Under the terms of the agreement, we
will assume responsibility for all activities, following
development-candidate nomination.
In July 2024, we announced an exclusive global
licensing agreement with Foreseen Biotechnology for FS001, an
antibody-drug conjugate with first-in-class potential. Under the
terms of the agreement, we will assume responsibility for Phase I
preparation activities.
We also announced today a new global partnership
outside the U.S with Day One Biopharmaceuticals for tovorafenib, an
oral, once-weekly, type II RAF inhibitor for pediatric low-grade
glioma. This is the most common form of childhood brain cancer.
Under the terms of the agreement, we will be responsible for the
regulatory and commercial activities for tovorafenib in all
territories outside of the U.S.
Consolidated financial statementsThe Board of
Directors approved the condensed consolidated financial statements
on 24 July 2024. The Company’s auditors performed a limited review
of the H1 2024 condensed consolidated financial statements. The
interim financial report, with regards to the regulated
information, will be available on ipsen.com in due course, under
the Reports and Accounts tab in the Investor Relations section.
Conference callA conference call and webcast for
investors and analysts will begin today at 1pm CET. Participants
can access the call and its details by registering here; webcast
details can be found here.
CalendarIpsen intends to publish its
year-to-date and third-quarter sales update on 24 October 2024.
NotesAll financial figures are in
€ millions (€m). The performance shown in this announcement
covers the six-month period to 30 June 2024 (H1 2024) and the
three-month period to 30 June 2024 (Q2 2024), compared to the
six-month period to 30 June 2023 (H1 2023) and the three-month
period to 30 June 2023 (Q2 2023), respectively.
Commentary is based on the performance in H1 2024, 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
Investors
Craig Marks +44 (0)7584 349 193
Nicolas Bogler +33 6 52 19 98 92
Media
Amy Wolf +41 79 576 07 23
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; possible failure of
products launches; and the exposure to litigation, including patent
litigation, and/or regulatory actions; and risks of tax adjustments
given the regular audits from tax authorities considering Ipsen’s
M&A activities and its presence in multiple geographies. 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 Extract of consolidated results. The
Company’s auditors performed a limited review of the condensed
consolidated financial statements.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.
- Ipsen PR_H1 2024 results announcement_25072024
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