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?
?
EURm? EURm? Actual CER(1)
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Growth platforms(2) 509.7 452.0 12.8% 16.2%
New medicines(3) 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%
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Total Sales 822.4 741.9 10.9% 13.3%
Highlights
* Total-sales growth of 13.3% at CER(1), or 10.9% as reported, driven by the
16.2%(1) increase in sales of the growth platforms(2) 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-stage(4) 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
(https://register.vevent.com/register/BI466c7a8caea5470f9c6a1633dda49cf8);
webcast details can be found here (http://ipsen.to/Q1_2024_Sales_Update).
Calendar
Ipsen intends to publish its half-year and second-quarter results on 25 July
2024.
Notes
All financial figures are in EUR millions (EURm). 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 (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/).
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(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.
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