Ipsen delivers strong sales in the first quarter of 2024, driven by growth platforms & new medicines, and confirms its full-year guidance
24 Abril 2024 - 2:00AM
Ipsen delivers strong sales in the first quarter of 2024, driven by
growth platforms & new medicines, and confirms its full-year
guidance
PARIS, FRANCE, 24 April 2024 - Ipsen (Euronext:
IPN; ADR: IPSEY), a global specialty-care biopharmaceutical
company, today presents its sales for the first quarter of
2024.
|
Q1 2024 |
Q1 2023 |
% change |
€m |
€m |
Actual |
CER1 |
Growth platforms2 |
509.7 |
452.0 |
12.8% |
16.2% |
New medicines3 |
45.5 |
14.3 |
n/a |
n/a |
Somatuline® |
257.8 |
263.2 |
-2.0% |
-1.3% |
Other |
9.5 |
12.4 |
-23.8% |
-20.5% |
Total Sales |
822.4 |
741.9 |
10.9% |
13.3% |
Highlights
- Total-sales growth of 13.3% at
CER1, or 10.9% as reported, driven by the
16.2%1 increase in sales of the growth
platforms2 and the increased contributions from
new medicines, while Somatuline sales declined by only
1.3%1
- Regulatory approval
and launch of Onivyde in the U.S. as a first-line treatment for
metastatic pancreatic ductal adenocarcinoma (mPDAC)
- Confirmation of
financial guidance for 2024
“An excellent first-quarter performance has laid
a solid foundation for Ipsen's growth in 2024”, commented David
Loew, Chief Executive Officer, Ipsen. “The delivery of our
strategic plan continues to be evidenced by a strong top line,
supported by the success of the growth platforms and the increased
contribution of the new medicines. Moreover, the pipeline continues
to deliver, illustrated this quarter by the regulatory approval in
the U.S. of Onivyde as a first-line treatment for pancreatic
cancer.
“This year marks a pivotal period for our growth
plans, with the launches of four new medicines or indications. Our
focus remains on the performance of our portfolio and the expansion
of our pipeline, and a well-defined strategy for sustainable growth
centred on enhancing the lives and medical outcomes of
patients.”Full-year 2024 guidance
Ipsen has confirmed its financial guidance for
2024, which excludes the impact of any potential additional
late-stage4 external-innovation opportunities:
- Total-sales growth greater than
6.0%, at constant currency. Based on the average level of exchange
rates in March 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.
Business update
In February 2024, Ipsen announced that the U.S.
Food and Drug Administration (FDA) had approved the supplemental
new drug application for Onivyde plus oxaliplatin, fluorouracil and
leucovorin (NALIRIFOX) as a first-line treatment for adults living
with mPDAC. This was the second approval for an Onivyde regimen in
mPDAC, after the FDA’s approval in 2015 of Onivyde plus
fluorouracil and leucovorin, following disease progression with
gemcitabine-based therapy. In conjunction with the approval in the
U.S. of Onivyde as a first-line treatment in adults living with
mPDAC, Orphan Drug Exclusivity was awarded and regulatory
exclusivity was extended to 2031, driven by the automatic
seven-year exclusivity period upon approval.
In April 2024, Ipsen announced an exclusive
global licensing agreement for STRO-003, an antibody-drug conjugate
(ADC) targeting the ROR1 tumor antigen. STRO-003 is in the final
stages of pre-clinical development. The agreement gives Ipsen
exclusive worldwide rights to develop and commercialize STRO-003
and is the first ADC candidate to join Ipsen’s expanding
pipeline.
Ipsen and Skyhawk Therapeutics announced, in
April 2024, the signing of an exclusive worldwide collaboration to
discover and develop novel small molecules that modulate RNA for
rare neurological diseases. The agreement includes an option
pursuant to which Ipsen would acquire an exclusive licence for the
worldwide rights to develop successful development candidates.
Onivyde litigation
In March 2024, Ipsen received a Paragraph IV
notice letter regarding a 505(b)(2) submission to the U.S. FDA by
Conjupro Biotherapeutics, Inc. (Conjupro), requesting approval to
market an irinotecan hydrochloride liposome injection for the
treatment of patients with mPDAC, following gemcitabine-based
therapy. The letter challenges various patents that protect Onivyde
and its use. In response, Ipsen filed in April 2024 a patent
infringement lawsuit against Conjupro and certain related corporate
entities in the U.S. District Court for the District of New Jersey
and will fully defend its rights as its patent portfolio includes
U.S. patent protection for the liposome composition to expire in
2027, with additional patents covering the formulation and approved
use in the treatment of patients with mPDAC following
gemcitabine-based therapy having expiration dates up to 2033, with
additional protection on the first-line use until 2036.
Conference call
A 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.
Calendar
Ipsen intends to publish its half-year and
second-quarter results on 25 July 2024.
Notes
All financial figures are in € millions
(€m). The performance shown in this announcement covers the
three-month period to 31 March 2024 (Q1 2024, the quarter),
compared to the three-month period to 31 March 2023
(Q1 2023).
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 fuelled 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
- 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.
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 Bylvay® (odevixibat), Tazverik® (tazemetostat) and
Sohonos® (palovarotene).4 Phase III clinical development or
later.
- Ipsen - Q1 2024 - sales announcement
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