* Total-sales growth in FY 2023 of 6.7% at CER(1) (3.4% as reported) included
strong sales from the growth platforms(2) 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 2024(3) comprises total-sales growth(4) greater than
6.0% at CER(1) and a core operating margin(5) 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 2022(6):
FY 2023 FY 2022 % change
EURm EURm Actual CER(1)
-------------------------------------------------------------------------
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) EUR9.15 EUR10.51 -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) EUR7.73 EUR7.81 -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 EUR65.1m, driven by solid free cash-flow generation of EUR710.9m.
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
EUR500m. 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 outlook(8):
* 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 Ipsen
Ipsen 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/EMA(9) 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 (https://www.ipsen.com/) (regulated-information section).
Conference call
A 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
(https://register.vevent.com/register/BIf6f25106b1004f9e9d4a6bf0a2055f94);
webcast details can be found here (http://ipsen.to/FYResults2023).
Calendar
Ipsen intends to publish its first-quarter sales update on 25 April 2024.
Notes
All financial figures are in EUR millions (EURm). 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 (https://www.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
Ioana 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
(https://www.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.
Â