Ipsen delivers strong results in 2025, driven by solid execution across all therapeutic areas, and provides 2026 guidance

• FY 2025 sales growth of 10.9% at CER¹, or 8.1% as reported, driven by growth of the three therapeutic areas of Oncology (4.1%¹), Rare Disease (102.5%¹) and Neuroscience (9.7%¹); Somatuline® sales growth of 4.3%¹, with all other products, excluding Somatuline, achieving double-digit sales growth of 14.2%¹
• FY 2025 core operating income of €1,294m, growing by 16.7% as reported, with a core operating margin of 35.2% of total sales, increasing by 2.6 points
• 2025 continued pipeline expansion, driven by significant regulatory and clinical milestones, integration of multiple preclinical assets with global rights and innovative approaches, and a mid-stage candidate from the acquisition of ImCheck Therapeutics
• Five major regulatory and clinical milestones expected in 2026, in addition to the full data readout for IPN10200 in an aesthetics indication
• Financial guidance² for 2026 including total sales growth greater than 13.0%³ at CER, assuming an acceleration of our portfolio excluding Somatuline as well as the growth of Somatuline due to generic lanreotide production challenges, and core operating margin greater than 35.0% of total sales

PARIS, FRANCE, 12 February 2026 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the full year (FY) 2025 and for the fourth quarter of 2025.

“In 2025, Ipsen delivered strong sales and profit growth,” said David Loew, Chief Executive Officer, Ipsen. “We continued to execute across all three therapeutic areas, with a notable performance from Iqirvo. We have advanced multiple pipeline programs and further strengthened our innovation engine through targeted business development, including the acquisition of Imcheck Therapeutics. We also achieved promising proof-of-concept for IPN10200, our first-in-class differentiated long-acting recombinant molecule.

We are expecting another year of double-digit sales growth for 2026, supported by accelerated performance across the entire portfolio and a better outlook for Somatuline given the production challenges faced by generic competition. We anticipate five regulatory and clinical milestones this year and to further deliver on our external innovation strategy.”

Full-year 2026 guidance and mid-term outlook
Ipsen has set for FY 2026 the following financial guidance:

• Total sales growth greater than 13.0%, at constant currency. Based on the average level of exchange rates in January 2026, an adverse effect on total sales of around 2% of currencies is expected
• Core operating margin greater than 35.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities

Guidance on total sales and core operating margin is assuming accelerated sales growth of the portfolio excluding Somatuline and the growth of Somatuline sales due to generic lanreotide challenges. It excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions.

As part of its ongoing review of long-term assumptions including competitive intensity and product lifecycle considerations, Ipsen no longer expects to achieve the €500m peak sales for Onivyde and Tazverik.

Based on higher expected Somatuline sales due to continued generic lanreotide production challenges and the performance of the broader portfolio, Ipsen is highly confident on its 2027 mid-term outlook to exceed the total-sales average growth⁵ of at least 7% per year for the period 2023-27 and core operating margin in 2027 of at least 32%⁶ of total sales.

Pipeline progress
During 2025, Ipsen achieved a number of important regulatory and clinical milestones across its portfolio, reflecting continued advancement of its pipeline across the three therapeutic areas.

In the first quarter of 2025, the regulatory filing for tovorafenib, an oral, type II RAF-kinase inhibitor for pediatric low-grade glioma, was accepted for review by the European Medicines Agency (EMA).

In May 2025, Ipsen presented Phase II data from the ELMWOOD study of Iqirvo® (elafibranor) at the European Association for the Study of the Liver (EASL) Congress, demonstrating a favorable safety profile and dose-dependent efficacy over 12 weeks in people living with primary sclerosing cholangitis, a condition with high unmet medical need.

In July 2025, the European Commission approved Cabometyx® (cabozantinib) for the treatment of previously treated advanced neuroendocrine tumors (NETs), based on positive results from the Phase III CABINET trial.

In September 2025, positive Phase II data from the LANTIC trial in aesthetics were reported, demonstrating a differentiated, long-acting clinical profile for IPN10200. During the year, Ipsen also initiated a Phase II study of IPN10200 in cervical dystonia, representing the fourth clinical study in the development plan of the global long-acting recombinant molecule across therapeutic and aesthetic indications.

In December 2025, Ipsen announced that the pivotal Phase II FALKON trial of fidrisertib in fibrodysplasia ossificans progressiva (FOP) did not meet its primary endpoint and that the study was subsequently closed; fidrisertib was generally well-tolerated, with no safety concerns identified.

In addition, Ipsen initiated multiple Phase I oncology studies across IPN01195, a RAF inhibitor, the antibody-drug conjugate IPN60300 and the T-cell activator IPN01203, further strengthening its targeted oncology pipeline.

External innovation
In December 2025, Ipsen expanded its immuno-oncology portfolio with the acquisition of ImCheck Therapeutics, a biotechnology company developing next-generation immuno-oncology therapies including IPN60340 (ICT01), a first-in-class monoclonal antibody targeting BTN3A, currently in Phase I/II development, with a Phase IIb/III study planned to start in 2026. IPN60340 has the potential to be a new standard of care in combination in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults.

Interim data orally presented at the annual American Society of Clinical Oncology 2025 from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, treatment response nearly doubled relative to those seen in historical standard-of-care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard-of-care (Ven-Aza). In January 2026, Ipsen also announced that IPN60340 received U.S. FDA Breakthrough Therapy Designation in first-line unfit acute myeloid leukemia.

In December 2025, Ipsen further strengthened its oncology and early-stage pipeline through two additional targeted business development and research collaborations. Ipsen entered into an exclusive licensing agreement with Simcere Zaiming for rights outside Greater China to SIM0613, an antibody–drug conjugate (ADC) targeting LRRC15. Ipsen also announced a new research collaboration and option agreement with the Université de Montréal and IRICoR, encompassing two discovery-stage programs focused on novel inhibition of pathways complementary to the MAP kinase pathway.

2026 Upcoming Milestones
Ipsen anticipates several key milestones across its portfolio in 2026, including:

• Tovorafenib (FIREFLY-1) - European regulatory decision for pediatric low-grade glioma
• Bylvay (BOLD) - Readout of pivotal Phase III in biliary atresia
• Iqirvo (ELSPIRE) - Readout of pivotal Phase III in primary biliary cholangitis
• Dysport (BEOND) - Readout of pivotal Phase III trials in chronic and episodic migraine
• IPN10200 (LANTIC) - Readout of Phase II in lateral canthal lines and forehead lines

These milestones reinforce Ipsen’s commitment to advancing innovative therapies and expanding treatment options for patients worldwide.

Full data from the Phase II LANTIC study of IPN10200, which demonstrated a positive first-in-class, differentiated long-acting clinical profile enabling the initiation of Phase III, are expected to be presented in the first half of 2026 at an upcoming congress.

Galderma arbitration
In January 2026, the Arbitral Tribunal of the International Chamber of Commerce (ICC) issued a final decision in favor of Ipsen, dismissing the claim brought by Galderma in connection with Ipsen’s termination of the R&D agreement. The Tribunal confirmed Ipsen’s full rights to its clinical-stage toxin programs in the aesthetics field, including IPN10200. Ipsen continues to assess all options to maximize the value of its long-acting program.

Environmental, Social and Governance
Ipsen took important steps in 2025 to deliver its ambitious sustainability strategy, continuing to embed sustainability across its operations and decision-making. From reducing its environmental footprint to advancing patient access and strengthening its workplace culture, Ipsen reinforced its commitment to delivering progress for patients, employees, communities, and the planet.

Ipsen made good progress across multiple environmental targets, including: 

• 54% reduction in Scopes 1 & 2 greenhouse gas emissions (vs. a 2019 baseline)
• 16% reduction in Scope 3, fully in line with our 2030 targets (vs. a 2019 baseline)
• 100% of Ipsen’s global electricity now comes from renewable sources
• 55% of the company fleet now comprised of electric vehicles as of 2025 through the Fleet for Future Project

Ipsen received an A rating from CDP for our best-practice environmental actions and transparency, and for demonstrating our comprehensive understanding of environmental dependencies, risks, and opportunities.

Ipsen is proud to be one of the first biopharmaceutical companies to achieve full gender parity within the Executive Leadership Team, and with women now representing 53% of the Global Leadership Team.

Consolidated financial statements
The Board of Directors approved the consolidated financial statements on 11 February 2026. 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 on ipsen.com in due course, under the Reports and Accounts tab in the Investor Relations section.

Conference call
A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the webcast here. Analysts can join the call and ask questions by registering here.

Calendar
Ipsen intends to publish its Q1 2026 sales on April 23rd, 2026.

Notes
All financial figures are in € millions (€m), unless otherwise noted. The performance shown in this announcement covers the twelve-month period to 31 December 2025 (FY 2025) and the three-month period to 31 December 2025 (Q4 2025), compared to the twelve-month period to 31 December 2024 (FY 2024) and the three-month period to 31 December 2024 (Q4 2024), respectively, unless stated otherwise. The commentary is based on the performance in FY 2025, 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 internal and 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.

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 and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; 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   Excluding any impact from potential late-stage (Phase III clinical development or later) external-innovation transactions.
³   Based on the average level of exchange rates in January 2026, an adverse impact on total sales of around 2% from currencies is expected.
⁴   Extract of consolidated results. The Company’s auditors performed an audit of the consolidated financial statements.
⁵   CAGR 2023-2027 at constant exchange rates.
⁶   Excluding any impact from potential late-stage (Phase III clinical development or later) external-innovation transactions.

Attachment

• Ipsen PR_FY 2025 Results Announcement_12022026