Ipsen delivers solid results in 2024, driven by strong performance across all therapeutic areas, and provides guidance for 2025

   -- FY 2024 total sales growth of 9.9% at CER1, or 8.7% as reported, with 
      growth driven by strong performance across all therapeutic areas, 
      including a 67.4% increase in the Rare Diseases portfolio, 9.2% in 
      Neuroscience, and 7.3% in Oncology; Somatuline$(R)$ (lanreotide) sales grew 
      by 5.6%, while all other products, excluding Somatuline, achieved 
      double-digit sales growth at 12.2% 
 
   -- FY 2024 core operating income of EUR1,109m, growing 10.8% as reported, 
      with core operating margin of 32.6% of total sales 
 
   -- Continued pipeline expansion in 2024, with significant regulatory 
      approvals, addition of several preclinical therapies with global rights 
      and innovative modalities, and a late-stage asset 
 
   -- Four key regulatory and clinical milestones expected in 2025, including 
      the Proof-of-Concept data readout for the Long-Acting Neurotoxin (LANT) 
 
   -- Financial guidance2 for 2025 including total sales growth greater than 
      5.0%3 at CER, and core operating margin greater than 30.0% of total sales, 
      based on accelerated sales growth of the ex-Somatuline portfolio and 
      assuming negative impact on Somatuline sales due to increased generic 
      competition in the U.S. and Europe 

PARIS, FRANCE, 13 February 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the full year 2024.

 
Extract of consolidated 
 results(4) for FY 2024 and 
 FY 2023:(4)                    FY 2024    FY 2023      % change 
-----------------------------  ----------  -------  ---------------- 
                                  EURm      EURm     Actual   CER(1) 
-----------------------------  ----------  -------  --------  ------ 
Total Sales                       3,400.6  3,127.5      8.7%    9.9% 
-----------------------------  ----------  -------  --------  ------ 
Core Operating Income             1,109.4  1,001.0     10.8% 
-----------------------------  ----------  -------  --------  ------ 
Core operating margin               32.6%    32.0%   +0.6pts 
-----------------------------  ----------  -------  --------  ------ 
Core Consolidated Net Profit        857.8    765.5     12.1% 
-----------------------------  ----------  -------  --------  ------ 
Core earnings per share 
 (fully diluted)                 EUR10.27  EUR9.15     12.3% 
-----------------------------  ----------  -------  --------  ------ 
IFRS Operating Income            496.7(5)    816.0    -39.1% 
-----------------------------  ----------  -------  --------  ------ 
IFRS operating margin               14.6%    26.1%  -11.5pts 
-----------------------------  ----------  -------  --------  ------ 
IFRS Consolidated Net Profit     347.3(5)    647.2    -46.3% 
-----------------------------  ----------  -------  --------  ------ 
IFRS earnings per share 
 (fully diluted)               EUR4.15(5)  EUR7.73    -46.3% 
-----------------------------  ----------  -------  --------  ------ 
Dividend per share(6)          EUR1.40(7)  EUR1.20     16.7% 
-----------------------------  ----------  -------  --------  ------ 
Free Cash Flow                      774.4    710.9      8.9% 
-----------------------------  ----------  -------  --------  ------ 
Closing net cash                    160.3     65.1       n/a 
-----------------------------  ----------  -------  --------  ------ 
 

"Ipsen delivered solid results and advanced its pipeline in 2024, laying a strong foundation for sustained growth," said David Loew, Chief Executive Officer, Ipsen. "With the successful global rollout of Iqirvo and Bylvay, and the U.S. launch of Onivyde, alongside multiple business development deals adding several innovative assets, we are well positioned to execute our strategic roadmap. This year, we look forward to achieving key milestones, including the first data readout for the Long-Acting Neurotoxin (LANT), and further expand and progress our pipeline across all three therapeutic areas to bring promising new medicines to patients."

Pipeline Progress

Significant regulatory milestones were achieved in 2024, including FDA approval of Onivyde(R) (irinotecan) for first-line pancreatic ductal adenocarcinoma (PDAC), along with accelerated U.S. approval and European approval for Iqirvo(R) (elafibranor), respectively. Additionally, Kayfanda(R) (odevixibat) was approved for Alagille syndrome $(ALGS)$ in the E.U.

The company also opted-in for the CABINET Phase III study of Cabometyx(R) (cabozantinib) in patients with advanced neuroendocrine tumors (NETs), with study results presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine.

An IND application was filed for IPN01194, an ERK inhibitor, advancing the potential medicine into clinical development with a Phase I/IIa trial in advanced solid tumors.

Ipsen improved further the depth and breadth of its pipeline by adding five preclinical innovative therapies with global rights and new modalities, and an ex-U.S. licensing agreement with DayOne Biopharmaceuticals for the late-stage oncology asset tovorafenib, an oral RAF inhibitor for pediatric low-grade glioma.

Two global licensing agreements for Antibody Drug Conjugate $(ADC)$ in oncology with Sutro Biopharma and Foreseen Biotechnology were signed. An extension of the oncology partnership with Marengo Therapeutics to include TriSTAR, a next-generation precision T-cell engager was completed, as well as more recently, in the fourth quarter, a global licensing agreement with Biomunex for a preclinical novel T-cell engager (TCE). A collaboration with Skyhawk Therapeutics to develop RNA-modulating small molecules for rare neurological diseases was also signed during the year.

Ipsen executed several divestments in 2024, including the sale of Increlex(R) (mecasermin injection) to Eton Pharmaceuticals and the sale of its rare pediatric disease Priority Review Voucher.

Environmental, Social and Governance

Ipsen took important steps in 2024 in delivering its ambitious sustainability strategy. The company continued to integrate sustainability across its operations. From reducing its environmental footprint to advancing patient access and fostering a strong workplace culture, the company increased its commitment to driving progress for patients, employees, communities, and the planet.

Our sustainability efforts were recognized across multiple environment initiatives. The company achieved a 45% reduction in Scopes 1 & 2 greenhouse gas emissions and a 25% reduction in Scope 3, fully in line with its 2030 targets (versus 2019 baseline). Significant efforts were made to engage suppliers and third parties in Ipsen's sustainability roadmap including the first-ever "Ipsen Supplier Sustainability Day". Following an intensive transformation project, 99.8% of Ipsen's global electricity now comes from renewable sources. Through the Fleet for Future project, the company continues to advance sustainable transportation, with 43% of its total company's fleet now electric vehicles as of 2024.

We remain committed to gender balance in leadership, with women now representing 55% of the Global Leadership Team.

2025 Upcoming Milestones

Ipsen anticipates several key milestones across its portfolio in 2025, including:

   -- Cabometyx (CABINET trial) -- Regulatory decision in Europe for advanced 
      neuroendocrine tumors (NETs), including pancreatic (pNETs) and 
      extra-pancreatic (epNETs) neuroendocrine tumors 
 
   -- Tovorafenib (FIREFLY-1 trial) -- Regulatory submission in Europe for 
      pediatric low-grade glioma 
 
   -- Fidrisertib (FALKON trial) -- Readout of the pivotal Phase IIb trial in 
      fibrodysplasia ossificans progressiva (FOP) 
 
   -- LANT88(LANTIC trial) -- Proof-of-concept data readout, evaluating its 
      potential in aesthetics 

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

2025 Financial Guidance

Ipsen has set for FY 2025 the following financial guidance, which excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions:

   -- Total sales growth greater than 5.0%, at constant currency. Based on the 
      average level of exchange rates in January 2025, a favorable effect on 
      total sales of around 1% from currencies is expected. 
 
   -- Core operating margin greater than 30.0% 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 based on accelerated sales growth of the ex-Somatuline portfolio and assumes negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe.

Consolidated financial statements

The Board of Directors approved the consolidated financial statements on 12 February 2025. 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 in due course on ipsen.com (regulated-information section).

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 Q1 2025 sales on April 16th, 2025.

Notes

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February 13, 2025 00:57 ET (05:57 GMT)