Paris (France), 26 October 2023
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical
company, today presents its sales performance for the year to date and the third
quarter of 2023.
YTD YTD Q3 Q3
2023 2022 % change 2023 2022 % change
EURm EURm Actual CER(1) EURm EURm Actual CER(1)
---------------------------------------------------------------------
Oncology 1,744.1 1,767.2 -1.3% 0.8% 574.5 603.1 -4.7% 0.8%
Neuroscience 489.0 407.7 19.9% 24.5% 164.8 160.7 2.5% 13.7%
Rare Disease 76.0 33.6 n/a n/a 33.2 11.0 n/a n/a
---------------------------------------------------------------------
Total Sales 2,309.1 2,208.5 4.6% 7.1% 772.4 774.8 -0.3% 6.5%
---------------------------------------------------------------------
Sales and pipeline highlights
1. Total-sales growth in the year to date of 7.1% at CER(1), or 4.6% as
reported, driven by the performance of the growth platforms(2), up by
16.1%(1), with Dysport(®) (abobotulinumtoxinA) up by 24.7%(1) and
Cabometyx(®) (cabozantinib) up by 24.4%(1), respectively. The performance
included contributions from new medicines Bylvay(®) (odevixibat),
Tazverik(®) (tazemetostat) and Sohonos(®) (palovarotene)
1. Further pipeline progress, including the regulatory approval and launch in
the U.S. of Sohonos(®) in Rare Disease and initial results from the CONTACT-
02 Phase III trial of Cabometyx(®) plus atezolizumab in Oncology
David Loew, Chief Executive Officer, commented:
"Ipsen's strategic success has been reflected in further sales and pipeline
progress so far this year. Our portfolio has performed well across the three
therapy areas, driven by strengthened commercial execution and the results of
our external-innovation strategy. Based on the solid sales momentum, today we
are confirming our guidance for the full year.
Further good news from the pipeline, including the regulatory approval of
Sohonos in the U.S., continue to provide additional options for patients with
real unmet medical needs. In the final quarter of the year, we look forward to
regulatory steps for elafibranor in primary biliary cholangitis, as well as
sharing further details on sustainable growth opportunities across our portfolio
and pipeline at our forthcoming capital-markets day."
Full-year 2023 guidance
Ipsen has confirmed its financial guidance for FY 2023:
* Total-sales growth greater than 6.0%, at constant exchange rates. Based on
the average level of exchange rates in September 2023, an adverse impact on
total sales of around 3.5% from currencies is expected
* Core operating margin greater than 30% of total sales
Pipeline development
In August 2023, it was announced that the U.S. Food and Drug Administration
(FDA) had approved Sohonos, the first and only treatment for people with
fibrodysplasia ossificans progressiva.
It was also announced that the global CONTACT-02 pivotal Phase III trial of
Cabometyx plus atezolizumab in metastatic castration-resistant prostate cancer
met one of two primary endpoints, demonstrating a statistically significant
improvement in progression-free survival at the primary analysis.
In October 2023, the European Medicines Agency's (EMA) Committee for Orphan
Medicinal Products confirmed its negative opinion recommending not to maintain
the orphan designation for Bylvay in Alagille syndrome (ALGS). This was despite
a positive opinion from the Committee for Medicinal Products for Human Use in
July 2023. To maintain Bylvay's orphan designation in the approved treatment of
progressive familial intrahepatic cholestasis, Ipsen is planning to resubmit to
the EMA under a new brand name for the treatment of ALGS by the end of 2023.
Galderma partnership
In September 2023, the Arbitral Tribunal of the International Chamber of
Commerce issued a final decision following a difference of opinion on the
regulatory-submission strategy for the liquid botulinum toxin type A, QM1114. In
October 2023, Ipsen announced that its partner, Galderma, had received a
Complete Response Letter from the U.S. FDA related to its Biologics License
Application for QM1114.
A second arbitration proceeding, related to the territorial scope of the
Dysport/Azzalure(®) aesthetics' partnership, is anticipated to conclude next
year.
AASLD call
To accompany the presentation of the ELATIVE Phase III trial results at the
American Association for the Study of Liver Diseases (AASLD) 2023 Annual World
Congress, Ipsen plans to host a conference call for analysts and investors on
14 November 2023, at 4.30pm CET. Participants can access the call and its
details by registering here
(https://register.vevent.com/register/BIf71792872a734228a9be957aacd707ea);
webcast details can be found here (http://ipsen.to/AASLDcall). A recording will
be available on ipsen.com (https://www.ipsen.com/).
Capital-markets day
The Company is planning to host a capital-markets event, starting at 12.30pm GMT
on 7 December 2023 in London. The event will be webcast live and details will be
available on ipsen.com in due course. In-person attendance will be by invitation
only.
Calendar
Ipsen intends to publish its full-year and fourth-quarter results on 8 February
2024.
Conference call: YTD 2023
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/BIf014092ad07b4d39ae1d974a3145db9b);
webcast details can be found here (https://edge.media-
server.com/mmc/p/s77mw9mu). A recording will be available on ipsen.com
(https://www.ipsen.com/).
Notes
All financial figures are in EUR millions (EURm). The performance shown in this
announcement covers the nine-month period to 30 September 2023 (YTD 2023) and
the three-month period to 30 September 2023 (Q3 2023), compared to nine-month
period to 30 September 2022 (YTD 2022) and the three-month period to 30
September 2022 (Q3 2022), respectively, unless stated otherwise. Commentary is
based on the performance in YTD 2023, 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 EUR3.0bn
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 5,300
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 (https://www.ipsen.com/investors/).
Contacts
Investors
Craig Marks Nicolas Bogler
Vice President, Investor Relations Senior Investor Relations Manager
+44 (0)7584 349 193 +33 6 52 19 98 92
Media
Amy Wolf
Vice President and Head of Corporate
Brand Strategy
and Communications
+41 79 576 07 23
Ioana Piscociu
Senior Manager, Global Media Relations
+33 6 69 09 12 96
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 2022 Universal Registration Document, available on ipsen.com.
--------------------------------------------------------------------------------
(1) At constant exchange rates (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.
(2) Dysport, Decapeptyl(®) (triptorelin), Cabometyx and Onivyde(®) (irinotecan).
Â