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

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   -- 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$(R)$ 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 EUR1,294m, 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.

 
Extract of consolidated results(4) 
 for FY25 and FY24                   FY 2025   FY 2024   % change 
                                       EURm      EURm    Actual    CER 
Total Sales                           3,675.9   3,400.6    8.1 %  10.9 % 
Core Operating Income                 1,294.1   1,109.4   16.7 % 
Core operating margin                  35.2 %    32.6 %  +2.6pts 
Core Consolidated Net Profit          1,009.1     857.8   17.6 % 
Core earnings per share (fully 
 diluted)                            EUR12.09  EUR10.27   17.8 % 
IFRS Operating Income                   625.9     496.7   26.0 % 
IFRS operating margin                  17.0 %    14.6 %  +2.4pts 
IFRS Consolidated Net Profit            444.5     347.3   28.0 % 
IFRS earnings per share (fully 
 diluted)                             EUR5.32   EUR4.15   28.3 % 
Free Cash Flow                        1,000.6     774.4   29.2 % 
Closing net cash/(debt)                 559.9     160.3      n/a 
 
 

"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 EUR500m 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 growth(5) 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(R) (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(R) (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.

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